Overview and General Information about Oral Presentation
- Daily Presentations During Work Rounds
- The New Patient Presentation
- The Holdover Admission Presentation
- Outpatient Clinic Presentations
- The structure of presentations varies from service to service (e.g. medicine vs. surgery), amongst subspecialties, and between environments (inpatient vs. outpatient). Applying the correct style to the right setting requires that the presenter seek guidance from the listeners at the outset.
- Time available for presenting is rather short, which makes the experience more stressful.
- Individual supervisors (residents, faculty) often have their own (sometimes quirky) preferences regarding presentation styles, adding another layer of variability that the presenter has to manage.
- Students are evaluated/judged on the way in which they present, with faculty using this as one way of gauging a student’s clinical knowledge.
- Done well, presentations promote efficient, excellent care. Done poorly, they promote tedium, low morale, and inefficiency.
General Tips:
- Practice, Practice, Practice! Do this on your own, with colleagues, and/or with anyone who will listen (and offer helpful commentary) before you actually present in front of other clinicians. Speaking "on-the-fly" is difficult, as rapidly organizing and delivering information in a clear and concise fashion is not a naturally occurring skill.
- Immediately following your presentations, seek feedback from your listeners. Ask for specifics about what was done well and what could have been done better – always with an eye towards gaining information that you can apply to improve your performance the next time.
- Listen to presentations that are done well – ask yourself, “Why was it good?” Then try to incorporate those elements into your own presentations.
- Listen to presentations that go poorly – identify the specific things that made it ineffective and avoid those pitfalls when you present.
- Effective presentations require that you have thought through the case beforehand and understand the rationale for your conclusions and plan. This, in turn, requires that you have a good grasp of physiology, pathology, clinical reasoning and decision-making - pushing you to read, pay attention, and in general acquire more knowledge.
- Think about the clinical situation in which you are presenting so that you can provide a summary that is consistent with the expectations of your audience. Work rounds, for example, are clearly different from conferences and therefore mandate a different style of presentation.
- Presentations are the way in which we tell medical stories to one another. When you present, ask yourself if you’ve described the story in an accurate way. Will the listener be able to “see” the patient the same way that you do? Can they come to the correct conclusions? If not, re-calibrate.
- It's O.K. to use notes, though the oral presentation should not simply be reduced to reading the admission note – rather, it requires appropriate editing/shortening.
- In general, try to give your presentations on a particular service using the same order and style for each patient, every day. Following a specific format makes it easier for the listener to follow, as they know what’s coming and when they can expect to hear particular information. Additionally, following a standardized approach makes it easier for you to stay organized, develop a rhythm, and lessens the chance that you’ll omit elements.
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Specific types of presentations
There are a number of common presentation-types, each with its own goals and formats. These include:
- Daily presentations during work rounds for patients known to a service.
- Newly admitted patients, where you were the clinician that performed the H&P.
- Newly admitted patients that were “handed off” to the team in the morning, such that the H&P was performed by others.
- Outpatient clinic presentations, covering several common situations.
Key elements of each presentation type are described below. Examples of how these would be applied to most situations are provided in italics. The formats are typical of presentations done for internal medicine services and clinics.
Note that there is an acceptable range of how oral presentations can be delivered. Ultimately, your goal is to tell the correct story, in a reasonable amount of time, so that the right care can be delivered. Nuances in the order of presentation, what to include, what to omit, etc. are relatively small points. Don’t let the pursuit of these elements distract you or create undue anxiety.
Daily presentations during work rounds of patients that you’re following:
- Organize the presenter (forces you to think things through)
- Inform the listener(s) of 24 hour events and plan moving forward
- Promote focused discussion amongst your listeners and supervisors
- Opportunity to reassess plan, adjust as indicated
- Demonstrate your knowledge and engagement in the care of the patient
- Rapid (5 min) presentation of the key facts
Key features of presentation:
- Opening one liner: Describe who the patient is, number of days in hospital, and their main clinical issue(s).
- 24-hour events: Highlighting changes in clinical status, procedures, consults, etc.
- Subjective sense from the patient about how they’re feeling, vital signs (ranges), and key physical exam findings (highlighting changes)
- Relevant labs (highlighting changes) and imaging
- Assessment and Plan : Presented by problem or organ systems(s), using as many or few as are relevant. Early on, it’s helpful to go through the main categories in your head as a way of making sure that you’re not missing any relevant areas. The broad organ system categories include (presented here head-to-toe): Neurological; Psychiatric; Cardiovascular; Pulmonary; Gastrointestinal; Renal/Genitourinary; Hematologic/Oncologic; Endocrine/Metabolic; Infectious; Tubes/lines/drains; Disposition.
Example of a daily presentation for a patient known to a team:
- Opening one liner: This is Mr. Smith, a 65 year old man, Hospital Day #3, being treated for right leg cellulitis
- MRI of the leg, negative for osteomyelitis
- Evaluation by Orthopedics, who I&D’d a superficial abscess in the calf, draining a moderate amount of pus
- Patient appears well, states leg is feeling better, less painful
- T Max 101 yesterday, T Current 98; Pulse range 60-80; BP 140s-160s/70-80s; O2 sat 98% Room Air
- Ins/Outs: 3L in (2 L NS, 1 L po)/Out 4L urine
- Right lower extremity redness now limited to calf, well within inked lines – improved compared with yesterday; bandage removed from the I&D site, and base had small amount of purulence; No evidence of fluctuance or undrained infection.
- Creatinine .8, down from 1.5 yesterday
- WBC 8.7, down from 14
- Blood cultures from admission still negative
- Gram stain of pus from yesterday’s I&D: + PMNS and GPCs; Culture pending
- MRI lower extremity as noted above – negative for osteomyelitis
- Continue Vancomycin for today
- Ortho to reassess I&D site, though looks good
- Follow-up on cultures: if MRSA, will transition to PO Doxycycline; if MSSA, will use PO Dicloxacillin
- Given AKI, will continue to hold ace-inhibitor; will likely wait until outpatient follow-up to restart
- Add back amlodipine 5mg/d today
- Hep lock IV as no need for more IVF
- Continue to hold ace-I as above
- Wound care teaching with RNs today – wife capable and willing to assist. She’ll be in this afternoon.
- Set up follow-up with PMD to reassess wound and cellulitis within 1 week
The Brand New Patient (admitted by you)
- Provide enough information so that the listeners can understand the presentation and generate an appropriate differential diagnosis.
- Present a thoughtful assessment
- Present diagnostic and therapeutic plans
- Provide opportunities for senior listeners to intervene and offer input
- Chief concern: Reason why patient presented to hospital (symptom/event and key past history in one sentence). It often includes a limited listing of their other medical conditions (e.g. diabetes, hypertension, etc.) if these elements might contribute to the reason for admission.
- The history is presented highlighting the relevant events in chronological order.
- 7 days ago, the patient began to notice vague shortness of breath.
- 5 days ago, the breathlessness worsened and they developed a cough productive of green sputum.
- 3 days ago his short of breath worsened to the point where he was winded after walking up a flight of stairs, accompanied by a vague right sided chest pain that was more pronounced with inspiration.
- Enough historical information has to be provided so that the listener can understand the reasons that lead to admission and be able to draw appropriate clinical conclusions.
- Past history that helps to shed light on the current presentation are included towards the end of the HPI and not presented later as “PMH.” This is because knowing this “past” history is actually critical to understanding the current complaint. For example, past cardiac catheterization findings and/or interventions should be presented during the HPI for a patient presenting with chest pain.
- Where relevant, the patient's baseline functional status is described, allowing the listener to understand the degree of impairment caused by the acute medical problem(s).
- It should be explicitly stated if a patient is a poor historian, confused or simply unaware of all the details related to their illness. Historical information obtained from family, friends, etc. should be described as such.
- Review of Systems (ROS): Pertinent positive and negative findings discovered during a review of systems are generally incorporated at the end of the HPI. The listener needs this information to help them put the story in appropriate perspective. Any positive responses to a more inclusive ROS that covers all of the other various organ systems are then noted. If the ROS is completely negative, it is generally acceptable to simply state, "ROS negative.”
- Other Past Medical and Surgical History (PMH/PSH): Past history that relates to the issues that lead to admission are typically mentioned in the HPI and do not have to be repeated here. That said, selective redundancy (i.e. if it’s really important) is OK. Other PMH/PSH are presented here if relevant to the current issues and/or likely to affect the patient’s hospitalization in some way. Unrelated PMH and PSH can be omitted (e.g. if the patient had their gall bladder removed 10y ago and this has no bearing on the admission, then it would be appropriate to leave it out). If the listener really wants to know peripheral details, they can read the admission note, ask the patient themselves, or inquire at the end of the presentation.
- Medications and Allergies: Typically all meds are described, as there’s high potential for adverse reactions or drug-drug interactions.
- Family History: Emphasis is placed on the identification of illnesses within the family (particularly among first degree relatives) that are known to be genetically based and therefore potentially heritable by the patient. This would include: coronary artery disease, diabetes, certain cancers and autoimmune disorders, etc. If the family history is non-contributory, it’s fine to say so.
- Social History, Habits, other → as relates to/informs the presentation or hospitalization. Includes education, work, exposures, hobbies, smoking, alcohol or other substance use/abuse.
- Sexual history if it relates to the active problems.
- Vital signs and relevant findings (or their absence) are provided. As your team develops trust in your ability to identify and report on key problems, it may become acceptable to say “Vital signs stable.”
- Note: Some listeners expect students (and other junior clinicians) to describe what they find in every organ system and will not allow the presenter to say “normal.” The only way to know what to include or omit is to ask beforehand.
- Key labs and imaging: Abnormal findings are highlighted as well as changes from baseline.
- Summary, assessment & plan(s) Presented by problem or organ systems(s), using as many or few as are relevant. Early on, it’s helpful to go through the main categories in your head as a way of making sure that you’re not missing any relevant areas. The broad organ system categories include (presented here head-to-toe): Neurological; Psychiatric; Cardiovascular; Pulmonary; Gastrointestinal; Renal/Genitourinary; Hematologic/Oncologic; Endocrine/Metabolic; Infectious; Tubes/lines/drains; Disposition.
- The assessment and plan typically concludes by mentioning appropriate prophylactic considerations (e.g. DVT prevention), code status and disposition.
- Chief Concern: Mr. H is a 50 year old male with AIDS, on HAART, with preserved CD4 count and undetectable viral load, who presents for the evaluation of fever, chills and a cough over the past 7 days.
- Until 1 week ago, he had been quite active, walking up to 2 miles a day without feeling short of breath.
- Approximately 1 week ago, he began to feel dyspneic with moderate activity.
- 3 days ago, he began to develop subjective fevers and chills along with a cough productive of red-green sputum.
- 1 day ago, he was breathless after walking up a single flight of stairs and spent most of the last 24 hours in bed.
- Diagnosed with HIV in 2000, done as a screening test when found to have gonococcal urethritis
- Was not treated with HAART at that time due to concomitant alcohol abuse and non-adherence.
- Diagnosed and treated for PJP pneumonia 2006
- Diagnosed and treated for CMV retinitis 2007
- Became sober in 2008, at which time interested in HAART. Started on Atripla, a combination pill containing: Efavirenz, Tonofovir, and Emtricitabine. He’s taken it ever since, with no adverse effects or issues with adherence. Receives care thru Dr. Smiley at the University HIV clinic.
- CD4 count 3 months ago was 400 and viral load was undetectable.
- He is a gay male, not currently sexually active. He has never used intravenous drugs.
- He has no history of asthma, COPD or chronic cardiac or pulmonary condition. No known liver disease. Hepatitis B and C negative. His current problem seems different to him then his past episode of PJP.
- Review of systems: negative for headache, photophobia, stiff neck, focal weakness, chest pain, abdominal pain, diarrhea, nausea, vomiting, urinary symptoms, leg swelling, or other complaints.
- Hypertension x 5 years, no other known vascular disease
- Gonorrhea as above
- Alcohol abuse above and now sober – no known liver disease
- No relevant surgeries
- Atripla, 1 po qd
- Omeprazole 20 mg, 1 PO, qd
- Lisinopril 20mg, qd
- Naprosyn 250 mg, 1-2, PO, BID PRN
- No allergies
- Both of the patient's parents are alive and well (his mother is 78 and father 80). He has 2 brothers, one 45 and the other 55, who are also healthy. There is no family history of heart disease or cancer.
- Patient works as an accountant for a large firm in San Diego. He lives alone in an apartment in the city.
- Smokes 1 pack of cigarettes per day and has done so for 20 years.
- No current alcohol use. Denies any drug use.
- Sexual History as noted above; has sex exclusively with men, last partner 6 months ago.
- Seated on a gurney in the ER, breathing through a face-mask oxygen delivery system. Breathing was labored and accessory muscles were in use. Able to speak in brief sentences, limited by shortness of breath
- Vital signs: Temp 102 F, Pulse 90, BP 150/90, Respiratory Rate 26, O2 Sat (on 40% Face Mask) 95%
- HEENT: No thrush, No adenopathy
- Lungs: Crackles and Bronchial breath sounds noted at right base. E to A changes present. No wheezing or other abnormal sounds noted over any other area of the lung. Dullness to percussion was also appreciated at the right base.
- Cardiac: JVP less than 5 cm; Rhythm was regular. Normal S1 and S2. No murmurs or extra heart sounds noted.
- Abdomen and Genital exams: normal
- Extremities: No clubbing, cyanosis or edema; distal pulses 2+ and equal bilaterally.
- Skin: no eruptions noted.
- Neurological exam: normal
- WBC 18 thousand with 10% bands;
- Normal Chem 7 and LFTs.
- Room air blood gas: pH of 7.47/ PO2 of 55/PCO2 of 30.
- Sputum gram stain remarkable for an abundance of polys along with gram positive diplococci.
- CXR remarkable for dense right lower lobe infiltrate without effusion.
- Monitored care unit, with vigilance for clinical deterioration.
- Hypertension: given significant pneumonia and unclear clinical direction, will hold lisinopril. If BP > 180 and or if clear not developing sepsis, will consider restarting.
- Low molecular weight heparin
- Code Status: Wishes to be full code full care, including intubation and ICU stay if necessary. Has good quality of life and hopes to return to that functional level. Wishes to reconsider if situation ever becomes hopeless. Older brother Tom is surrogate decision maker if the patient can’t speak for himself. Tom lives in San Diego and we have his contact info. He is aware that patient is in the hospital and plans on visiting later today or tomorrow.
- Expected duration of hospitalization unclear – will know more based on response to treatment over next 24 hours.
The holdover admission (presenting data that was generated by other physicians)
- Handoff admissions are very common and present unique challenges
- Understand the reasons why the patient was admitted
- Review key history, exam, imaging and labs to assure that they support the working diagnostic and therapeutic plans
- Does the data support the working diagnosis?
- Do the planned tests and consults make sense?
- What else should be considered (both diagnostically and therapeutically)?
- This process requires that the accepting team thoughtfully review their colleagues efforts with a critical eye – which is not disrespectful but rather constitutes one of the main jobs of the accepting team and is a cornerstone of good care *Note: At some point during the day (likely not during rounds), the team will need to verify all of the data directly with the patient.
- 8-10 minutes
- Chief concern: Reason for admission (symptom and/or event)
- Temporally presented bullets of events leading up to the admission
- Review of systems
- Relevant PMH/PSH – historical information that might affect the patient during their hospitalization.
- Meds and Allergies
- Family and Social History – focusing on information that helps to inform the current presentation.
- Habits and exposures
- Physical exam, imaging and labs that were obtained in the Emergency Department
- Assessment and plan that were generated in the Emergency Department.
- Overnight events (i.e. what happened in the Emergency Dept. and after the patient went to their hospital room)? Responses to treatments, changes in symptoms?
- How does the patient feel this morning? Key exam findings this morning (if seen)? Morning labs (if available)?
- Assessment and Plan , with attention as to whether there needs to be any changes in the working differential or treatment plan. The broad organ system categories include (presented here head-to-toe): Neurological; Psychiatric; Cardiovascular; Pulmonary; Gastrointestinal; Renal/Genitourinary; Hematologic/Oncologic; Endocrine/Metabolic; Infectious; Tubes/lines/drains; Disposition.
- Chief concern: 70 yo male who presented with 10 days of progressive shoulder pain, followed by confusion. He was brought in by his daughter, who felt that her father was no longer able to safely take care for himself.
- 10 days ago, Mr. X developed left shoulder pain, first noted a few days after lifting heavy boxes. He denies falls or direct injury to the shoulder.
- 1 week ago, presented to outside hospital ER for evaluation of left shoulder pain. Records from there were notable for his being afebrile with stable vitals. Exam notable for focal pain anteriorly on palpation, but no obvious deformity. Right shoulder had normal range of motion. Left shoulder reported as diminished range of motion but not otherwise quantified. X-ray negative. Labs remarkable for wbc 8, creat 2.2 (stable). Impression was that the pain was of musculoskeletal origin. Patient was provided with Percocet and told to see PMD in f/u
- Brought to our ER last night by his daughter. Pain in shoulder worse. Also noted to be confused and unable to care for self. Lives alone in the country, home in disarray, no food.
- ROS: negative for falls, prior joint or musculoskeletal problems, fevers, chills, cough, sob, chest pain, head ache, abdominal pain, urinary or bowel symptoms, substance abuse
- Hypertension
- Coronary artery disease, s/p LAD stent for angina 3 y ago, no symptoms since. Normal EF by echo 2 y ago
- Chronic kidney disease stage 3 with creatinine 1.8; felt to be secondary to atherosclerosis and hypertension
- aspirin 81mg qd, atorvastatin 80mg po qd, amlodipine 10 po qd, Prozac 20
- Allergies: none
- Family and Social: lives alone in a rural area of the county, in contact with children every month or so. Retired several years ago from work as truck driver. Otherwise non-contributory.
- Habits: denies alcohol or other drug use.
- Temp 98 Pulse 110 BP 100/70
- Drowsy though arousable; oriented to year but not day or date; knows he’s at a hospital for evaluation of shoulder pain, but doesn’t know the name of the hospital or city
- CV: regular rate and rhythm; normal s1 and s2; no murmurs or extra heart sounds.
- Left shoulder with generalized swelling, warmth and darker coloration compared with Right; generalized pain on palpation, very limited passive or active range of motion in all directions due to pain. Right shoulder appearance and exam normal.
- CXR: normal
- EKG: sr 100; nl intervals, no acute changes
- WBC 13; hemoglobin 14
- Na 134, k 4.6; creat 2.8 (1.8 baseline 4 m ago); bicarb 24
- LFTs and UA normal
- Vancomycin and Zosyn for now
- Orthopedics to see asap to aspirate shoulder for definitive diagnosis
- If aspiration is consistent with infection, will need to go to Operating Room for wash out.
- Urine electrolytes
- Follow-up on creatinine and obtain renal ultrasound if not improved
- Renal dosing of meds
- Strict Ins and Outs.
- follow exam
- obtain additional input from family to assure baseline is, in fact, normal
- Since admission (6 hours) no change in shoulder pain
- This morning, pleasant, easily distracted; knows he’s in the hospital, but not date or year
- T Current 101F Pulse 100 BP 140/80
- Ins and Outs: IVF Normal Saline 3L/Urine output 1.5 liters
- L shoulder with obvious swelling and warmth compared with right; no skin breaks; pain limits any active or passive range of motion to less than 10 degrees in all directions
- Labs this morning remarkable for WBC 10 (from 13), creatinine 2 (down from 2.8)
- Continue with Vancomycin and Zosyn for now
- I already paged Orthopedics this morning, who are en route for aspiration of shoulder, fluid for gram stain, cell count, culture
- If aspirate consistent with infection, then likely to the OR
- Continue IVF at 125/h, follow I/O
- Repeat creatinine later today
- Not on any nephrotoxins, meds renaly dosed
- Continue antibiotics, evaluation for primary source as above
- Discuss with family this morning to establish baseline; possible may have underlying dementia as well
- SC Heparin for DVT prophylaxis
- Code status: full code/full care.
Outpatient-based presentations
There are 4 main types of visits that commonly occur in an outpatient continuity clinic environment, each of which has its own presentation style and purpose. These include the following, each described in detail below.
- The patient who is presenting for their first visit to a primary care clinic and is entirely new to the physician.
- The patient who is returning to primary care for a scheduled follow-up visit.
- The patient who is presenting with an acute problem to a primary care clinic
- The specialty clinic evaluation (new or follow-up)
It’s worth noting that Primary care clinics (Internal Medicine, Family Medicine and Pediatrics) typically take responsibility for covering all of the patient’s issues, though the amount of energy focused on any one topic will depend on the time available, acuity, symptoms, and whether that issue is also followed by a specialty clinic.
The Brand New Primary Care Patient
Purpose of the presentation
- Accurately review all of the patient’s history as well as any new concerns that they might have.
- Identify health related problems that need additional evaluation and/or treatment
- Provide an opportunity for senior listeners to intervene and offer input
Key features of the presentation
- If this is truly their first visit, then one of the main reasons is typically to "establish care" with a new doctor.
- It might well include continuation of therapies and/or evaluations started elsewhere.
- If the patient has other specific goals (medications, referrals, etc.), then this should be stated as well. Note: There may well not be a "chief complaint."
- For a new patient, this is an opportunity to highlight the main issues that might be troubling/bothering them.
- This can include chronic disorders (e.g. diabetes, congestive heart failure, etc.) which cause ongoing symptoms (shortness of breath) and/or generate daily data (finger stick glucoses) that should be discussed.
- Sometimes, there are no specific areas that the patient wishes to discuss up-front.
- Review of systems (ROS): This is typically comprehensive, covering all organ systems. If the patient is known to have certain illnesses (e.g. diabetes), then the ROS should include the search for disorders with high prevalence (e.g. vascular disease). There should also be some consideration for including questions that are epidemiologically appropriate (e.g. based on age and sex).
- Past Medical History (PMH): All known medical conditions (in particular those requiring ongoing treatment) are listed, noting their duration and time of onset. If a condition is followed by a specialist or co-managed with other clinicians, this should be noted as well. If a problem was described in detail during the “acute” history, it doesn’t have to be re-stated here.
- Past Surgical History (PSH): All surgeries, along with the year when they were performed
- Medications and allergies: All meds, including dosage, frequency and over-the-counter preparations. Allergies (and the type of reaction) should be described.
- Social: Work, hobbies, exposures.
- Sexual activity – may include type of activity, number and sex of partner(s), partner’s health.
- Smoking, Alcohol, other drug use: including quantification of consumption, duration of use.
- Family history: Focus on heritable illness amongst first degree relatives. May also include whether patient married, in a relationship, children (and their ages).
- Physical Exam: Vital signs and relevant findings (or their absence).
- Key labs and imaging if they’re available. Also when and where they were obtained.
- Summary, assessment & plan(s) presented by organ system and/or problems. As many systems/problems as is necessary to cover all of the active issues that are relevant to that clinic. This typically concludes with a “health care maintenance” section, which covers age, sex and risk factor appropriate vaccinations and screening tests.
The Follow-up Visit to a Primary Care Clinic
- Organize the presenter (forces you to think things through).
- Accurately review any relevant interval health care events that might have occurred since the last visit.
- Identification of new symptoms or health related issues that might need additional evaluation and/or treatment
- If the patient has no concerns, then verification that health status is stable
- Review of medications
- Provide an opportunity for listeners to intervene and offer input
- Reason for the visit: Follow-up for whatever the patient’s main issues are, as well as stating when the last visit occurred *Note: There may well not be a “chief complaint,” as patients followed in continuity at any clinic may simply be returning for a visit as directed by their doctor.
- Events since the last visit: This might include emergency room visits, input from other clinicians/specialists, changes in medications, new symptoms, etc.
- Review of Systems (ROS): Depth depends on patient’s risk factors and known illnesses. If the patient has diabetes, then a vascular ROS would be done. On the other hand, if the patient is young and healthy, the ROS could be rather cursory.
- PMH, PSH, Social, Family, Habits are all OMITTED. This is because these facts are already known to the listener and actionable aspects have presumably been added to the problem list (presented at the end). That said, these elements can be restated if the patient has a new symptom or issue related to a historical problem has emerged.
- MEDS : A good idea to review these at every visit.
- Physical exam: Vital signs and pertinent findings (or absence there of) are mentioned.
- Lab and Imaging: The reason why these were done should be mentioned and any key findings mentioned, highlighting changes from baseline.
- Assessment and Plan: This is most clearly done by individually stating all of the conditions/problems that are being addressed (e.g. hypertension, hypothyroidism, depression, etc.) followed by their specific plan(s). If a new or acute issue was identified during the visit, the diagnostic and therapeutic plan for that concern should be described.
The Focused Visit to a Primary Care Clinic
- Accurately review the historical events that lead the patient to make the appointment.
- Identification of risk factors and/or other underlying medical conditions that might affect the diagnostic or therapeutic approach to the new symptom or concern.
- Generate an appropriate assessment and plan
- Allow the listener to comment
Key features of the presentation:
- Reason for the visit
- History of Present illness: Description of the sequence of symptoms and/or events that lead to the patient’s current condition.
- Review of Systems: To an appropriate depth that will allow the listener to grasp the full range of diagnostic possibilities that relate to the presenting problem.
- PMH and PSH: Stating only those elements that might relate to the presenting symptoms/issues.
- PE: Vital signs and key findings (or lack thereof)
- Labs and imaging (if done)
- Assessment and Plan: This is usually very focused and relates directly to the main presenting symptom(s) or issues.
The Specialty Clinic Visit
Specialty clinic visits focus on the health care domains covered by those physicians. For example, Cardiology clinics are interested in cardiovascular disease related symptoms, events, labs, imaging and procedures. Orthopedics clinics will focus on musculoskeletal symptoms, events, imaging and procedures. Information that is unrelated to these disciples will typically be omitted. It’s always a good idea to ask the supervising physician for guidance as to what’s expected to be covered in a particular clinic environment.
- Highlight the reason(s) for the visit
- Review key data
- Provide an opportunity for the listener(s) to comment
- 5-7 minutes
- If it’s a consult, state the main reason(s) that the patient was referred as well as who referred them.
- If it’s a return visit, state the reasons why the patient is being followed in the clinic and when the last visit took place
- If it’s for an acute issue, state up front what the issue is Note: There may well not be a “chief complaint,” as patients followed in continuity in any clinic may simply be returning for a return visit as directed
- For a new patient, this highlights the main things that might be troubling/bothering the patient.
- For a specialty clinic, the history presented typically relates to the symptoms and/or events that are pertinent to that area of care.
- Review of systems , focusing on those elements relevant to that clinic. For a cardiology patient, this will highlight a vascular ROS.
- PMH/PSH that helps to inform the current presentation (e.g. past cardiac catheterization findings/interventions for a patient with chest pain) and/or is otherwise felt to be relevant to that clinic environment.
- Meds and allergies: Typically all meds are described, as there is always the potential for adverse drug interactions.
- Social/Habits/other: as relates to/informs the presentation and/or is relevant to that clinic
- Family history: Focus is on heritable illness amongst first degree relatives
- Physical Exam: VS and relevant findings (or their absence)
- Key labs, imaging: For a cardiology clinic patient, this would include echos, catheterizations, coronary interventions, etc.
- Summary, assessment & plan(s) by organ system and/or problems. As many systems/problems as is necessary to cover all of the active issues that are relevant to that clinic.
- Reason for visit: Patient is a 67 year old male presenting for first office visit after admission for STEMI. He was referred by Dr. Goins, his PMD.
- The patient initially presented to the ER 4 weeks ago with acute CP that started 1 hour prior to his coming in. He was found to be in the midst of a STEMI with ST elevations across the precordial leads.
- Taken urgently to cath, where 95% proximal LAD lesion was stented
- EF preserved by Echo; Peak troponin 10
- In-hospital labs were remarkable for normal cbc, chem; LDL 170, hdl 42, nl lfts
- Uncomplicated hospital course, sent home after 3 days.
- Since home, he states that he feels great.
- Denies chest pain, sob, doe, pnd, edema, or other symptoms.
- No symptoms of stroke or TIA.
- No history of leg or calf pain with ambulation.
- Prior to this admission, he had a history of hypertension which was treated with lisinopril
- 40 pk yr smoking history, quit during hospitalization
- No known prior CAD or vascular disease elsewhere. No known diabetes, no family history of vascular disease; He thinks his cholesterol was always “a little high” but doesn’t know the numbers and was never treated with meds.
- History of depression, well treated with prozac
- Discharge meds included: aspirin, metoprolol 50 bid, lisinopril 10, atorvastatin 80, Plavix; in addition he takes Prozac for depression
- Taking all of them as directed.
- Patient lives with his wife; they have 2 grown children who are no longer at home
- Works as a computer programmer
- Smoking as above
- ETOH: 1 glass of wine w/dinner
- No drug use
- No known history of cardiovascular disease among 2 siblings or parents.
- Well appearing; BP 130/80, Pulse 80 regular, 97% sat on Room Air, weight 175lbs, BMI 32
- Lungs: clear to auscultation
- CV: s1 s2 no s3 s4 murmur
- No carotid bruits
- ABD: no masses
- Ext; no edema; distal pulses 2+
- Cath from 4 weeks ago: R dominant; 95% proximal LAD; 40% Cx.
- EF by TTE 1 day post PCI with mild Anterior Hypokinesis, EF 55%, no valvular disease, moderate LVH
- Labs of note from the hospital following cath: hgb 14, plt 240; creat 1, k 4.2, lfts normal, glucose 100, LDL 170, HDL 42.
- EKG today: SR at 78; nl intervals; nl axis; normal r wave progression, no q waves
- Plan: aspirin 81 indefinitely, Plavix x 1y
- Given nitroglycerine sublingual to have at home.
- Reviewed symptoms that would indicate another MI and what to do if occurred
- Plan: continue with current dosages of meds
- Chem 7 today to check k, creatinine
- Plan: Continue atorvastatin 80mg for life
- Smoking cessation: Doing well since discharge without adjuvant treatments, aware of supports.
- Plan: AAA screening ultrasound
Tools for the Patient Presentation
The formal patient presentation.
- Posing the Clinical Question
- Searching the Medical Literature for EBM
Sources & Further Reading
First Aid for the Wards
Lingard L, Haber RJ. Teaching and learning communications in medicine: a rhetorical approach . Academic Medicine. 74(5):507-510 1999 May.
Lingard L, Haber RJ. What do we mean by "relevance"? A clinical and rhetorical definition with implications for teaching and learning the case-presentation format . Academic Medicine. 74(10):S124-S127.
The Oral Presentation (A Practical Guide to Clinical Medicine, UCSD School of Medicine) http://meded.ucsd.edu/clinicalmed/oral.htm
"Classically, the formal oral presentation is given in 7 minutes or less. Although it follows the same format as a written report, it is not simply regurgitation. A great presentation requires style as much as substance; your delivery must be succinct and smooth. No time should be wasted on superfluous information; one can read about such matters later in your admit note. Ideally, your presentation should be formulated so that your audience can anticipate your assessment and plan; that is, each piece of information should clue the listener into your thinking process and your most likely diagnosis." [ Le, et al, p. 15 ]
Types of Patient Presentations
New Patient
New patients get the traditional H&P with assessment and plan. Give the chief complaint and a brief and pertinent HPI. Next give important PMH, PSH, etc. The ROS is often left out, as anything important was in the HPI. The PE is reviewed. Only give pertinent positives and negatives. The assessment and plan should include what you think is wrong and, briefly, why. Then, state what you plan to do for the patient, including labs. Be sure to know why things are being done: you will be asked.
The follow-up presentation differs from the presentation of a new patient. It is an abridged presentation, perhaps referencing major patient issues that have been previously presented, but focusing on new information about these issues and/or what has changed. Give the patient’s name, age, date of admission, briefly review the present illness, physical examination and admitting diagnosis. Then report any new finding, laboratory tests, diagnostic procedures and changes in medications.
The attending physician will ask the patient’s permission to have the medical student present their case. After making the proper introductions the attending will let the patient know they may offer input or ask questions at any point. When presenting at bedside the student should try to involve the patient.
Preparing for the Presentation
There are four things you must consider before you do your oral presentation
- Occasion (setting and circumstances)
Ask yourself what do you want the presentation to do
- Present a new patient to your preceptor : the amount of detail will be determined by your preceptor. It is also likely to reflect your development and experience, with less detail being required as you progress.
- Present your patient at working or teaching rounds : the amount of detail will be determined by the customs of the group. The focus of the presentation will be influenced by the learning objectives of working responsibilities of the group.
- Request a consultant’s advice on a clinical problem : the presentation will be focused on the clinical question being posed to the consultant.
- Persuade others about a diagnosis and plan : a shorter presentation which highlights the pertinent positives and negatives that are germane to the diagnosis and/or plan being suggested.
- Enlist cooperation required for patient care : a short presentation focusing on the impact your audience can have in addressing the patient’s issues.
Preparation
- Patient evaluation : history, physical examination, review of tests, studies, procedures, and consultants’ recommendations.
- Selected reading : reference texts; to build a foundational understanding.
- Literature search : for further elucidation of any key references from selected reading, and to bring your understanding up to date, since reference text information is typically three to seven years old.
- Write-up : for oral presentation, just succinct notes to serve as a reminder or reference, since you’re not going to be reading your presentation.
Knowledge (Be prepared to answer questions about the following)
- Pathophysiology
- Complications
- Differential diagnosis
- Course of conditions
- Diagnostic tests
- Medications
- Essential Evidence Plus
Template for Oral Presentations
Chief Complaint (CC)
The opening statement should give an overview of the patient, age, sex, reason for visit and the duration of the complaint. Give marital status, race, or occupation if relevant. If your patient has a history of a major medical problem that bears strongly on the understanding of the present illness, include it. For ongoing care, give a one sentence recap of the history.
History of Present Illness (HPI)
This will be very similar to your written HPI. Present the most important problem first. If there is more than one problem, treat each separately. Present the information chronologically. Cover one system before going onto the next. Characterize the chief complaint – quality, severity, location, duration, progression, and include pertinent negatives. Items from the ROS that are unrelated to the present problem may be mentioned in passing unless you are doing a very formal presentation. When you do your first patient presentation you may be expected to go into detail. For ongoing care, present any new complaints.
Review of Systems (ROS)
Most of the ROS is incorporated at the end of the HPI. Items that are unrelated to the present problem may be briefly mentioned. For ongoing care, present only if new complaints.
Past Medical History (PMH)
Discuss other past medical history that bears directly on the current medical problem. For ongoing care, have the information available to respond to questions.
Past Surgical History
Provide names of procedures, approximate dates, indications, any relevant findings or complications, and pathology reports, if applicable. For ongoing care, have the information available to respond to questions.
Allergies/Medications
Present all current medications along with dosage, route and frequency. For the follow-up presentation just give any changes in medication. For ongoing care, note any changes.
Smoking and Alcohol (and any other substance abuse)
Note frequency and duration. For ongoing care, have the information available to respond to questions.
Social/Work History
Home, environment, work status and sexual history. For ongoing care, have the information available to respond to questions.
Family History Note particular family history of genetically based diseases. For ongoing care, have the information available to respond to questions.
Physical Exam/Labs/Other Tests
Include all significant abnormal findings and any normal findings that contribute to the diagnosis. Give a brief, general description of the patient including physical appearance. Then describe vital signs touching on each major system. Try to find out in advance how thorough you need to be for your presentation. There are times when you will be expected to give more detail on each physical finding, labs and other test results. For ongoing care, mention only further positive findings and relevant negative findings.
Assessment and Plan
Give a summary of the important aspects of the history, physical exam and formulate the differential diagnosis. Make sure to read up on the patient’s case by doing a search of the literature.
- Include only the most essential facts; but be ready to answer ANY questions about all aspects of your patient.
- Keep your presentation lively.
- Do not read the presentation!
- Expect your listeners to ask questions.
- Follow the order of the written case report.
- Keep in mind the limitation of your listeners.
- Beware of jumping back and forth between descriptions of separate problems.
- Use the presentation to build your case.
- Your reasoning process should help the listener consider a differential diagnosis.
- Present the patient as well as the illness .
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Presenting a patient is an essential skill that is rarely taught
Clinical presenting is the language that doctors use to communicate with each other every day of their working lives. Effective communication between doctors is crucial, considering the collaborative nature of medicine. As a medical student and later as a doctor you will be expected to present cases to peers and senior colleagues. This may be in the setting of handovers, referring a patient to another specialty, or requesting an opinion on a patient.
A well delivered case presentation will facilitate patient care, act a stimulus for timely intervention, and help identify individual and group learning needs. 1 Case presentations are also used as a tool for assessing clinical competencies at undergraduate and postgraduate level.
Medical students are taught how to take histories, examine, and communicate effectively with patients. However, we are expected to learn how to present effectively by observation, trial, and error.
Principles of presentation
Remember that the purpose of the case presentation is to convey your diagnostic reasoning to the listener. By the end of your presentation the examiner should have a clear view of the patient’s condition. Your presentation should include all the facts required to formulate a management plan.
There are no hard and fast rules for a perfect presentation, rather the content of each presentation should be determined by the case, the context, and the audience. For example, presenting a newly admitted patient with complex social issues on a medical ward round will be very different from presenting a patient with a perforated duodenal ulcer who is in need of an emergency laparotomy.
Whether you’re presenting on a busy ward round or during an objective structured clinical …
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How to Give an Excellent Medical Presentation
- By Sulaiman Ahmad
- July 22, 2019
- Medical Student , Pre-med
- Self-improvement
In medicine, we are constantly learning from each other. Professors stand in front of lecture halls to teach the fundamental knowledge needed to pass board exams and to treat our patients. Outside of the classroom, medical students, researchers, and physicians attend conferences to communicate ideas and update their colleagues with oral and poster presentations. In the clinic, students and resident physicians relay pertinent patient information to the physician in charge. Eventually, you will find yourself in front of an audience listening to your talk or an attending grading your clinical presentation. First, I will discuss what it takes to make an excellent presentation. I will then finish this topic by providing guidelines for perfecting different types of presentations.
Critical Elements of an Excellent Presentation
do some research.
Your audience will consider you an expert on the information you deliver. It is your job to achieve the expected level of comprehension of the topic. After choosing a topic, gather enough background information from diverse but appropriate sources (e.g., journals articles, relevant chapters in textbooks, personal discussion with subject matter experts, online videos). Your research should provide you with a thorough understanding of the topic and a list of the important facts supporting your take-home message . Any gaps in your knowledge will become evident during your presentation. The goal is to develop confidence in your understanding of the topic and ability to share what you know.
Know Your Audience
Before putting your presentation together, take a moment to assess the baseline understanding of your expected audience . Ultimately your audience should walk away having learned something new. Try to figure out their collective interest, reasons for attending, and prior experience with the topic. Knowing your audience will allow you to focus on information that will keep them engaged and interested. For example, premed students have a different understanding of medical topics than medical students. A presentation on the same subject should be different for both groups. If your listeners have different levels of expertise, take a moment to explain the fundamental concept, then build up the language and complexity to allow everyone to benefit from the information shared. Your audience is the reason why you are presenting.
Tell a Story
The human brain is wired to remember stories , especially if presented logically. A presentation is about the information shared, but it should also include the presenters’ passion, excitement, and personal style. All topics can be formatted to include characters, a description of the setting, plot, conflict, and a resolution. The story should allow the audience to take a journey with you. The hardest part is identifying the start and endpoint of your story and which details are needed. Make every word count by checking if it adds value to your narrative. Consider using metaphors, real examples, and descriptions that give life to your words .
Practicing your presentation is a vital step in developing an excellent presentation. You can memorize a script. However, memorization can reduce your connection with the audience. But in certain situations, scripts are quick and effective means of communicating important facts. Another approach is drafting bullet points of the main ideas and practicing the natural flow of information . This method allows your personality to shine on stage. To become comfortable speaking, start by practicing on your own . You can also record yourself with a cellphone or tablet and review the recording to evaluate your performance. Next, find a small group to present in front of and ask for their honest assessment . Eventually, your presentation will feel natural, and your stage presence will aid in communicating your main idea.
Q&A Session
Usually, your presentation does not end until after a question and answer session. Most presentations should include approximately five minutes in the end for the audience to ask questions . This part of the presentation allows you to clarify or further explain any part of your presentation. A question can also lead to expanding your presentation beyond what you originally planned to discuss . It is important for you to understand what is being asked and address the specific question directly. And if you do not have an answer, it is okay to admit that you do not know . Questions will force you to be creative and truly test your knowledge of the topic.
Different Types of Presentations
Presentations have many different forms, each with different goals; thus, each form requires a unique approach. In medicine, professors and clinician often provide students with lecture objectives and PowerPoint presentations that guide the students in their hour-long lecture. Conferences are a researcher’s platform to share their lab’s progress and conclusions. The last presentation I will go into is the clinical presentation a student typically performs for the physician in charge.
The main purpose of the lecture is to educate the attendees. We all have had great professors captivate our attention and other experiences that were a complete waste of time. But what makes some lectures better than others? The lecturer’s knowledge on the topic becomes obvious, and their stage presence confirms how comfortable they are with the topic. If you are tasked with lecturing on a topic or a series, ensure that you have a solid understanding and address your learning objectives in the time allotted . The main concepts should be repeated multiple times throughout the lecture, followed by examples . Your PowerPoint slides should be limited to only main points and images that support your talking points. After difficult concepts are covered, ask questions to gauge your audience’s understanding . It is better to reemphasize a concept before building up to more complex learning objectives.
Research Presentation
Attending a conference is exciting, especially if you are representing your lab with an oral presentation. It is an opportunity to share your research story, from the point of identifying a question to the process of reaching a conclusion. Realize your audience will include Primary Investigators, post-docs, and Ph.D. students that are also experts in the field . Attempt to grab the audience’s attention from the beginning by providing them with a reason to care. Then continue to explain how your study relates to the published work . After building up the background, address how you arrived at your research question. The most exciting part of your presentation should be explaining your conclusions and the path you took to get there. Finish up strong by discussing the implications of your findings and how they will have an impact in the field . The natural flow of information will come with practice and a deep understanding of your research topic. Presenting as a student usually leads to networking with professors and clinicians that can help you progress in your career.
Patient Presentation
Medical students learn how to take a patient’s history and perform a physical exam, but it is more challenging to reason through your clinical findings and subsequently present to an attending . Your clinical presentation style will change depending on the environment, medical department, and supervising physician . Upon joining a medical team, discuss the expectations and preference with each physician . It may be a good idea to draft a script that can get you started on organizing your patient presentation. The success of your presentation is correlated to your knowledge of the basic sciences and ability to critically assess the patient’s history and physical exam; the more you learn and read, the easier decision making and producing a plan becomes. Another important element is practicing your presentation style until it comes out naturally . Take the time to listen to your peers and experienced colleagues; learn from their mistakes and strengths . After concluding your presentation, ask for feedback and practice implementing the suggestions. You will be the eyes and ears for the physicians in charge, perfecting your patient presentation will help get the care the patients need while making everyone’s job a little easier.
Final remarks
There are some basic steps to achieving an excellent presentation: know the topic well, understand who you’re presenting to, develop a memorable story, and practice until it comes out naturally. A career in medicine is very versatile; you can be at the forefront of the next generation of physicians sharing your experiences or updating the science community with your research conclusions. At the minimum, you will be presenting the patient in the clinic. Thus, presenting is a skill every physician must master.
Sulaiman Ahmad
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7: Atypical Presentations of Illness in Older Adults
Carla M. Perissinotto, MD, MHS; Christine Ritchie, MD, MSPH
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Introduction, defining atypical presentations, identifying patients at risk.
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Traditional education of health care clinicians hinges on typical presentations of common illnesses. Yet, what is often left out from medical training is the frequent occurrence of atypical presentations of illness in older adults. These presentations are termed “ atypical ” because they lack the usual signs and symptoms characterizing a particular condition or diagnosis. In older adults, “atypical” presentations are actually quite common. For example, a change in behavior or functional ability is often the only sign of a new, potentially serious illness. Failure to recognize atypical presentations may lead to worse outcomes, missed diagnoses, and missed opportunities for treatment of common conditions in older patients.
In medical education, teaching about atypical presentations of medical illness in the older patient offers a unique opportunity to introduce key geriatric principles to trainees at all levels of training. Furthermore, atypical medical presentations in the older adult are now an Accreditation for Graduate Medical Education (ACGME) Geriatrics competency, underscoring the importance of integrating this concept into medical education for all learners.
The definition of an atypical presentation of illness is: when an older adult presents with a disease state that is missing some of the traditional core features of the illness usually seen in younger patients . Atypical presentations usually include one of 3 features: (a) vague presentation of illness, (b) altered presentation of illness, or (c) nonpresentation of illness (ie, underreporting).
The prevalence of atypical presentation of illness in older adults increases with age. With the aging of the world’s population, atypical presentations of illness will represent an increasingly large proportion of illness presentations. The most common risk factors include:
Increasing age (especially age 85 years or older)
Multiple medical conditions (“multimorbidity”)
Multiple medications (or “polypharmacy”)
Cognitive or functional impairment
Understanding which patients may be more at risk of atypical disease presentation will guide clinicians to more astutely pick up subtle signs of illness. Rather than approaching a patient visit in the “traditional” way, the clinician may also need to expand beyond the “typical” evaluation of illness and incorporate questions or exam findings that correlate with an atypical presentation ( Table 7–1 ). For example, recognition of an atypical presentation of illness requires a clinician to pay more attention to small changes in cognition compared to baseline. In the case of a patient with dementia, this can be difficult to determine as some older adults with dementia still experience minor daily variations in cognition. Gathering this baseline level of information requires patience, time, and having reliable caregivers and family member informants. Many times, in order to arrive at an accurate history of present illness, the clinician will have to undertake a systematic investigative approach.
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Preparing the Research Presentation
If you have never presented a paper at a scientific meeting, you should read this article. Even if you have presented before, it is likely that this article contains information that will improve your presentation. This article contains a set of practical, proven steps that will guide your preparation of the presentation. Our assumptions are that you will schedule appropriate planning and preparation time, are interested in doing the best job possible, and know that a quality presentation is a combination of good research and communication skills. This and subsequent articles will focus on planning, preparation, creating visual aids (slides), and presentation skills for a scientific presentation. The intent of this series of articles is to help you make a favorable impression at the scientific meeting and reap the rewards, personal and professional, of a job well done.
To begin with, you need to create an outline of the topics you might present at the meeting. Your outline should follow the IMRAC format (introduction, methods, results, and conclusion). This format is chosen because your audience understands it and expects it. If you have already prepared a paper for publication, it can be a rich source of content for the topic outline.
To get you started, we have prepared a generic outline to serve as an example. We recognize that a generic outline does not necessarily adapt to all research designs, but we ask you to think, "How can I adapt this to my situation?" To help you visualize the content you might include in the outline, two types of examples have been included, one that describes a cross-sectional study using a survey methodology (example A), and a second using a combination of a case-control and cohort designs (example B).
Use the Preparing the Research Presentation Checklist to assist you in preparing the topic outline.
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Breast Cancer Clinical Presentation
- Author: Pavani Chalasani, MD, MPH; Chief Editor: John V Kiluk, MD, FACS more...
- Sections Breast Cancer
- Practice Essentials
- Pathophysiology
- Epidemiology
- Physical Examination
- Approach Considerations
- Breast Cancer Screening
- Ultrasonography
- Magnetic Resonance Imaging
- Imaging Studies for Staging
- Accuracy of Breast Imaging Modalities
- Breast Biopsy
- HER2 Testing
- Breast Cancer Staging
- Additional Testing
- Tumor Molecular Testing
- Treatment of Invasive Breast Cancer
- Systemic Adjuvant Therapy for Breast Cancer
- Treatment of Carcinoma in Situ
- Treatment of Locally Advanced and Inflammatory Breast Cancer
- Systemic Treatment of Metastatic Breast Cancer
- Surgical Treatment of Metastatic Breast Cancer
- Bone Health Management
- Pharmacologic Reduction of Breast Cancer Risk
- Prophylactic Mastectomy
- Long-Term Monitoring
- Integrative Therapy
- Medication Summary
- Antineoplastics, Alkylating
- Antineoplastics, Anthracycline
- Calcium Metabolism Modifiers
- Antineoplastics, Antimetabolite
- Antineoplastics, Vinca Alkaloid
- Monoclonal Antibodies
- Tyrosine Kinase Inhibitors
- Antineoplastics, Antimicrotubular
- Aromatase Inhibitors
- CDK Inhibitors
- Antineoplastics, PARP Inhibitors
- Antineoplastics, Estrogen Receptor Antagonist
- PD-1/PD-L1 Inhibitors
- PI3K Inhibitors
- AKT Inhibitors
- Questions & Answers
- Media Gallery
Many early breast cancers are asymptomatic, particularly if they were discovered during a breast-screening program. Larger tumors may present as a painless mass. Pain or discomfort is not usually a symptom of breast cancer; only 5% of patients with a malignant mass present with breast pain.
Often, the purpose of the history is not diagnosis but risk assessment. A family history of breast cancer in a first-degree relative is the most widely recognized breast cancer risk factor.
The US Preventive Services Task Force (USPSTF) guidelines on risk assessment, genetic counseling, and genetic testing for BRCA-related cancer in women are as follows [ 89 ] :
Women who have family members with breast, ovarian, tubal, or peritoneal cancer should be screened to identify a family history that may be associated with an increased risk for mutations in the breast cancer susceptibility genes BRCA1 or BRCA2
Women who have positive screening results should receive genetic counseling and then BRCA testing if warranted
Women without a family history associated with an increased risk for mutations should not receive routine genetic counseling or BRCA testing
If the patient has not noticed a lump, then signs and symptoms indicating the possible presence of breast cancer may include the following:
- Change in breast size or shape
- Skin dimpling or skin changes (eg, thickening, swelling, or redness)
- Recent nipple inversion or skin change or other nipple abnormalities (eg, ulceration, retraction, or spontaneous bloody discharge)
- Nipple discharge, particularly if bloodstained
- Axillary lump
To detect subtle changes in breast contour and skin tethering, the examination must include an assessment of the breasts with the patient upright with arms raised. The following findings should raise concern:
- Lump or contour change
- Skin tethering
- Nipple inversion
- Dilated veins
- Redness or eczemalike rash involving nipple or surrounding area ( mammary Paget disease )
- Edema or peau d’orange
The nature of palpable lumps is often difficult to determine clinically, but the following features should raise concern:
- Irregularity
- Focal nodularity
- Asymmetry compared with the other breast
- Fixation to skin or muscle (assess fixation to muscle by moving the lump in the line of the pectoral muscle fibers with the patient bracing her arms against her hips)
A complete examination includes assessment for lymphatic and distant metastases; in descending order of frequency, distant metastases are to bone, lung, liver, and brain. [ 90 ] Thus, the assessment should include the axillae and supraclavicular fossae, the chest and sites of skeletal pain, and abdominal and neurologic examinations. The clinician should be alert to symptoms of metastatic spread, such as the following:
- Symptoms of hypercalcemia
- Breathing difficulties
- Abdominal distention
- Localizing neurologic signs
- Altered cognitive function
The clinical evaluation should include a thorough assessment of specific risk factors for breast cancer (see Breast Cancer Risk Factors ).
Breast Cancer Signs and Symptoms. American Cancer Society. Available at https://www.cancer.org/cancer/types/breast-cancer/screening-tests-and-early-detection/breast-cancer-signs-and-symptoms.html . January 14, 2022; Accessed: May 6, 2024.
Breast Cancer Screening and Diagnosis. National Comprehensive Cancer Network. Available at https://www.nccn.org/professionals/physician_gls/pdf/breast-screening.pdf . Version 2.2024 — April 9, 2024; Accessed: May 6, 2024.
American Cancer Society Recommendations for the Early Detection of Breast Cancer. American Cancer Society. Available at https://www.cancer.org/cancer/types/breast-cancer/screening-tests-and-early-detection/american-cancer-society-recommendations-for-the-early-detection-of-breast-cancer.html . January 14, 2022; Accessed: August 17, 2023.
[Guideline] Qaseem A, Lin JS, Mustafa RA, Horwitch CA, Wilt TJ, Clinical Guidelines Committee of the American College of Physicians., et al. Screening for Breast Cancer in Average-Risk Women: A Guidance Statement From the American College of Physicians. Ann Intern Med . 2019 Apr 16. 170 (8):547-560. [QxMD MEDLINE Link] . [Full Text] .
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Lancellotti P, Nkomo VT, Badano LP, Bergler J, Bogaert J, Davin L, et al. Expert consensus for multi-modality imaging evaluation of cardiovascular complications of radiotherapy in adults: a report from the European Association of Cardiovascular Imaging and the American Society of Echocardiography. Eur Heart J Cardiovasc Imaging . 2013 Aug. 14(8):721-40. [QxMD MEDLINE Link] .
[Guideline] Greenlee H, Balneaves L, Carlson M, et al. Clinical Practice Guidelines on the Use of Integrative Therapies as Supportive Care in Patients Treated for Breast Cancer. J Natl Cancer Inst . 2014. 50:346-358. [Full Text] .
Maia LO, Beaussant Y, Garcia ACM. The Therapeutic Potential of Psychedelic-assisted Therapies for Symptom Control in Patients Diagnosed With Serious Illness: A Systematic Review. J Pain Symptom Manage . 2022 Jun. 63 (6):e725-e738. [QxMD MEDLINE Link] .
Lehto RH, Miller M, Sender J. The Role of Psilocybin-Assisted Psychotherapy to Support Patients With Cancer: A Critical Scoping Review of the Research. J Holist Nurs . 2022 Sep. 40 (3):265-280. [QxMD MEDLINE Link] .
Olsson Möller U, Beck I, Rydén L, Malmström M. A comprehensive approach to rehabilitation interventions following breast cancer treatment - a systematic review of systematic reviews. BMC Cancer . 2019 May 20. 19 (1):472. [QxMD MEDLINE Link] . [Full Text] .
Smith RA, Andrews KS, Brooks D, Fedewa SA, Manassaram-Baptiste D, Saslow D, et al. Cancer screening in the United States, 2019: A review of current American Cancer Society guidelines and current issues in cancer screening. CA Cancer J Clin . 2019 May. 69 (3):184-210. [QxMD MEDLINE Link] . [Full Text] .
Saslow D, Boetes C, Burke W, Harms S, Leach MO, Lehman CD, et al. American Cancer Society guidelines for breast screening with MRI as an adjunct to mammography. CA Cancer J Clin . 2007 Mar-Apr. 57 (2):75-89. [QxMD MEDLINE Link] .
[Guideline] Practice Bulletin Number 179: Breast Cancer Risk Assessment and Screening in Average-Risk Women. Obstet Gynecol . 2017 Jul. 130 (1):e1-e16. [QxMD MEDLINE Link] . [Full Text] .
[Guideline] Schünemann HJ, Lerda D, Quinn C, et al, European Commission Initiative on Breast Cancer (ECIBC) Contributor Group. Breast Cancer Screening and Diagnosis: A Synopsis of the European Breast Guidelines. Ann Intern Med . 2019 Nov 26. [QxMD MEDLINE Link] . [Full Text] .
Visvanathan K, Hurley P, Bantug E, Brown P, Col NF, Cuzick J, et al. Use of pharmacologic interventions for breast cancer risk reduction: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol . 2013 Aug 10. 31 (23):2942-62. [QxMD MEDLINE Link] .
[Guideline] US Preventive Services Task Force., Owens DK, Davidson KW, Krist AH, Barry MJ, Cabana M, et al. Medication Use to Reduce Risk of Breast Cancer: US Preventive Services Task Force Recommendation Statement. JAMA . 2019 Sep 3. 322 (9):857-867. [QxMD MEDLINE Link] .
[Guideline] Allison KH, Hammond MEH, Dowsett M, McKernin SE, Carey LA, Fitzgibbons PL, et al. Estrogen and Progesterone Receptor Testing in Breast Cancer: ASCO/CAP Guideline Update. J Clin Oncol . 2020 Jan 13. JCO1902309. [QxMD MEDLINE Link] .
[Guideline] Morrow M, Van Zee KJ, Solin LJ, Houssami N, Chavez-MacGregor M, Harris JR, et al. Society of Surgical Oncology-American Society for Radiation Oncology-American Society of Clinical Oncology Consensus Guideline on Margins for Breast-Conserving Surgery With Whole-Breast Irradiation in Ductal Carcinoma in Situ. Pract Radiat Oncol . 2016 Sep-Oct. 6 (5):287-95. [QxMD MEDLINE Link] . [Full Text] .
Moran MS, Schnitt SJ, Giuliano AE, Harris JR, Khan SA, Horton J, et al. Society of Surgical Oncology-American Society for Radiation Oncology consensus guideline on margins for breast-conserving surgery with whole-breast irradiation in stages I and II invasive breast cancer. Int J Radiat Oncol Biol Phys . 2014 Mar 1. 88 (3):553-64. [QxMD MEDLINE Link] .
[Guideline] Smith BD, Bellon JR, Blitzblau R, et al. Radiation therapy for the whole breast: Executive summary of an American Society for Radiation Oncology (ASTRO) evidence-based guideline. Practical Radiation Oncology . 2018. [Full Text] .
[Guideline] Burstein HJ, Lacchetti C, Anderson H, Buchholz TA, Davidson NE, Gelmon KE, et al. Adjuvant Endocrine Therapy for Women With Hormone Receptor-Positive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update on Ovarian Suppression. J Clin Oncol . 2016 May 10. 34 (14):1689-701. [QxMD MEDLINE Link] . [Full Text] .
Burstein HJ, Temin S, Anderson H, Buchholz TA, Davidson NE, Gelmon KE, et al. Adjuvant endocrine therapy for women with hormone receptor-positive breast cancer: american society of clinical oncology clinical practice guideline focused update. J Clin Oncol . 2014 Jul 20. 32 (21):2255-69. [QxMD MEDLINE Link] .
[Guideline] Harris LN, Ismaila N, McShane LM, Andre F, Collyar DE, Gonzalez-Angulo AM, et al. Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline. J Clin Oncol . 2016 Apr 1. 34 (10):1134-50. [QxMD MEDLINE Link] .
[Guideline] Paluch-Shimon S, Pagani O, Partridge AH, Abulkhair O, Cardoso MJ, Dent RA, et al. ESO-ESMO 3rd international consensus guidelines for breast cancer in young women (BCY3). Breast . 2017 Oct. 35:203-217. [QxMD MEDLINE Link] . [Full Text] .
[Guideline] Runowicz CD, Leach CR, Henry NL, Henry KS, Mackey HT, Cowens-Alvarado RL, et al. American Cancer Society/American Society of Clinical Oncology Breast Cancer Survivorship Care Guideline. CA Cancer J Clin . 2016 Jan-Feb. 66 (1):43-73. [QxMD MEDLINE Link] . [Full Text] .
[Guideline] Freedman RA, Minami CA, Winer EP, et al. Individualizing Surveillance Mammography for Older Patients After Treatment for Early-Stage Breast Cancer: Multidisciplinary Expert Panel and International Society of Geriatric Oncology Consensus Statement. JAMA Oncol . 2021 Jan 28. [QxMD MEDLINE Link] .
[Guideline] Cardoso F, Kyriakides S, Ohno S, Penault-Llorca F, Poortmans P, Rubio IT, et al. Early breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up†. Ann Oncol . 2019 Aug 1. 30 (8):1194-1220. [QxMD MEDLINE Link] . [Full Text] .
- Anatomy of the breast.
- Intrinsic subtypes of breast cancer.
- Breast cancer. Intraductal carcinoma, comedo type. Distended duct with intact basement membrane and central tumor necrosis.
- Breast cancer. Intraductal carcinoma, noncomedo type. Distended duct with intact basement membrane, micropapillary, and early cribriform growth pattern.
- Breast cancer. Lobular carcinoma in situ. Enlargement and expansion of lobule with monotonous population of neoplastic cells.
- Breast cancer. Infiltrating ductal carcinoma. Low-grade carcinoma with well-developed glands invading fibrous stroma.
- Breast cancer. Colloid (mucinous) carcinoma. Nests of tumor cells in pool of extracellular mucin.
- Breast cancer. Papillary carcinoma. Solid papillary growth pattern with early cribriform and well-developed thin papillary fronds.
- Anatomy of the breast. Courtesy of Wikimedia Commons (Patrick J Lynch, medical illustrator).
- Table 1. Accuracy of Breast Imaging Modalities
- Table 2. Grading System in Invasive Breast Cancer (Modified Bloom and Richardson)
- Table 3. Ductal Carcinoma in Situ Subtypes
- Table 4. TNM Classification for Breast Cancer
- Table 5. Histologic grade
- Table 6. Anatomic stage/prognostic groups
- Table 7. Clinical prognostic stage
- Table 8. Pathological prognostic stage
- Table 9. Hormone Agents Used in Breast Cancer
- Table 10. Targeted Chemotherapy for Metastatic Breast Cancer
- Table 11. Combination Regimens for Metastatic Breast Cancer
- Table 12. Follow-up Recommendations for Breast Cancer Survivors
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Mammography | 63-95% (>95% palpable, 50% impalpable, 83-92% in women older than 50 y; decreases to 35% in dense breasts) | 14-90% (90% palpable) | 10-50% (94% palpable) | Initial investigation for symptomatic breast in women older than 35 y and for screening; investigation of choice for microcalcification |
Ultrasonography | 68-97% palpable | 74-94% palpable | 92% (palpable) | Initial investigation for palpable lesions in women younger than 35 y |
MRI | 86-100% | 21-97% (< 40% primary cancer) | 52% | Scarred breast, implants, multifocal lesions, and borderline lesions for breast conservation; may be useful in screening high-risk women |
Scintigraphy | 76-95% palpable, 52-91% impalpable | 62-94% (94% impalpable) | 70-83% (83% palpable, 79% impalpable) | Lesions >1 cm and axilla assessment; may help predict drug resistance |
PET | 96% (90% axillary metastases) | 100% |
| Axilla assessment, scarred breast, and multifocal lesions |
MRI = magnetic resonance imaging; PET = positron emission tomography; PPV = positive predictive value. |
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A. Tubule formation | >75% | 10-75% | < 10% |
B. Mitotic count/HPF (microscope- and field-dependent) | < 7 | 7-12 | >12 |
C. Nuclear size and pleomorphism | Near normal; little variation | Slightly enlarged; moderate variation | Markedly enlarged; marked variation |
Grade I cancer if total score (A + B + C) is 3-5 | |||
Grade II cancer if total score (A + B + C) is 6 or 7 | |||
Grade III cancer if total score (A + B + C) is 8 or 9 | |||
HPF = high-power field. |
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Nuclear grade | High | Low |
Estrogen receptor | Often negative | Positive |
Distribution | Continuous | Multifocal |
Necrosis | Present | Absent |
Local recurrence | High | Low |
Prognosis | Worse | Better |
DCIS = ductal carcinoma in situ. |
| |
TX | Primary tumor cannot be assessed |
T0 | No evidence of primary tumor |
Tis | Carcinoma in situ |
Tis (DCIS) | Ductal carcinoma in situ |
Tis (Paget) | Paget disease of the nipple NOT associated with invasive carcinoma and/or carcinoma in situ (DCIS) in the underlying breast parenchyma. Carcinomas in the breast parenchyma associated with Paget disease are categorized on the basis of the size and characteristics of the parenchymal disease, although the presence of Paget disease should still be noted |
T1 | Tumor ≤ 20 mm in greatest dimension |
T1mi | Tumor ≤ 1 mm in greatest dimension |
T1a | Tumor > 1 mm but ≤ 5 mm in greatest dimension (round any measurement >1.0-1.9 mm to 2 mm) |
T1b | Tumor > 5 mm but ≤ 10 mm in greatest dimension |
T1c | Tumor > 10 mm but ≤ 20 mm in greatest dimension |
T2 | Tumor > 20 mm but ≤ 50 mm in greatest dimension |
T3 | Tumor > 50 mm in greatest dimension |
T4 | Tumor of any size with direct extension to the chest wall and/or to the skin (ulceration or skin nodules), not including invasion of dermis alone |
T4a | Extension to chest wall, not including only pectoralis muscle adherence/invasion |
T4b | Ulceration and/or ipsilateral satellite nodules and/or edema (including peau d’orange) of the skin, which do not meet the criteria for inflammatory carcinoma |
T4c | Both T4a and T4b |
T4d | Inflammatory carcinoma |
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cNX | Regional lymph nodes cannot be assessed (eg, previously removed) |
cN0 | No regional lymph node metastasis (on imaging or clinical examination) |
cN1 | Metastasis to movable ipsilateral level I, II axillary lymph node(s) |
cN1mi | Micrometastases (approximately 200 cells, larger than 0.2 mm, but none larger than 2.0 mm) |
cN2 | Metastases in ipsilateral level I, II axillary lymph nodes that are clinically fixed or matted; in ipsilateral internal mammary nodes in the absence of clinically evident axillary lymph node metastases |
cN2a | Metastases in ipsilateral level I, II axillary lymph nodes fixed to one another (matted) or to other structures |
cN2b | Metastases only in ipsilateral internal mammary nodes and in the absence of axillary lymph node metastases |
cN3 | Metastases in ipsilateral infraclavicular (level III axillary) lymph node(s), with or without level I, II axillary node involvement, in ipsilateral internal mammary lymph node(s) with level I, II axillary lymph node metastasis; metastases in ipsilateral supraclavicular lymph node(s), with or without axillary or internal mammary lymph node involvement |
cN3a | Metastasis in ipsilateral infraclavicular lymph node(s) |
cN3b | Metastasis in ipsilateral internal mammary lymph node(s) and axillary lymph node(s) |
cN3c | Metastasis in ipsilateral supraclavicular lymph node(s) |
Note: (sn) and (f) suffixes should be added to the N category to denote confirmation of metastasis by sentinel node biopsy or fine needle aspiration/core needle biopsy, respectively. | |
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pNX | Regional lymph nodes cannot be assessed (for example, previously removed, or not removed for pathologic study) |
pN0 | No regional lymph node metastasis identified histologically, or isolated tumor cell clusters (ITCs) only. ITCs are defined as small clusters of cells ≤ 0.2 mm, or single tumor cells, or a cluster of < 200 cells in a single histologic cross-section; ITCs may be detected by routine histology or by immunohistochemical (IHC) methods; nodes containing only ITCs are excluded from the total positive node count for purposes of N classification but should be included in the total number of nodes evaluated |
pN0(i) | No regional lymph node metastases histologically, negative IHC |
pN0(i+) | ITCs only in regional lymph node(s) |
pN0(mol-) | No regional lymph node metastases histologically, negative molecular findings (reverse transcriptase polymerase chain reaction [RT-PCR]) |
pN0(mol+) | Positive molecular findings by RT-PCR; no ITCs detected |
pN1 | Micrometastases; or metastases in 1-3 axillary lymph nodes and/or in internal mammary nodes; and/or in clinically negative internal mammary nodes with micrometastases or macrometastases by sentinel lymph node biopsy |
pN1mi | Micrometastases (200 cells, > 0.2 mm but none > 2.0 mm) |
pN1a | Metastases in 1-3 axillary lymph nodes (at least 1 metastasis > 2.0 mm) |
pN1b | Metastases in ipsilateral internal mammary lymph nodes, excluding ITCs, detected by sentinel lymph node biopsy |
pN1c | Metastases in 1-3 axillary lymph nodes and in internal mammary sentinel nodes (ie, pN1a and pN1b combined) |
pN2 | Metastases in 4-9 axillary lymph nodes; or positive ipsilateral internal mammary lymph nodes by imaging in the absence of axillary lymph node metastases |
pN2a | Metastases in 4-9 axillary lymph nodes (at least 1 tumor deposit > 2.0 mm) |
pN2b | Clinically detected* metastases in internal mammary lymph nodes with or without microscopic confirmation; with pathologically negative axillary lymph nodes |
pN3 | Metastases in ≥ 10 axillary lymph nodes; in infraclavicular (level III axillary) lymph nodes; or positive ipsilateral internal mammary lymph nodes by imaging in the presence of one or more positive level I, II axillary lymph nodes; in > 3 axillary lymph nodes and micrometastases or macrometastases by sentinel lymph node biopsy in clinically negative ipsilateral internal mammary lymph nodes; or in ipsilateral supraclavicular lymph nodes |
pN3a | Metastases in ≥ 10 axillary lymph nodes (at least 1 tumor deposit > 2.0 mm); metastases to the infraclavicular (level III axillary lymph) nodes |
pN3b | pN1a or pN2a in the presence of cN2b (positive internal mammary nodes by imaging) pN2a in the presence of pN1b |
pN3c | Metastases in ipsilateral supraclavicular lymph nodes |
*"Clinically detected" is defined as detected by imaging studies (excluding lymphoscintigraphy) or by clinical examination and having characteristics highly suspicious for malignancy or a presumed pathologic macrometastasis on the basis of FNA biopsy with cytologic examination. | |
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M0 | No clinical or radiographic evidence of distant metastasis |
cM0(i+) | No clinical or radiographic evidence of distant metastases in the presence of tumor cells or deposits no larger than 0.2 mm detected microscopically or by molecular techniques in circulating blood, bone marrow, or other nonregional nodal tissue in a patient without symptoms or signs of metastase |
cM1 | Distant metastases detected by clinical and radiographic means |
pM1 | Any histologically proven metastases in distant organs; or if in non-regional nodes, metastases > 0.2 mm |
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GX | Grade cannot be assessed |
G1 | Low combined histologic grade (favorable) |
G2 | Intermediate combined histologic grade (moderately favorable) |
G3 | High combined histologic grade (unfavorable) |
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0 | Tis | N0 | M0 |
IA | T1 | N0 | M0 |
IB | T0 | N1mi | M0 |
| T1 | N1mi | M0 |
IIA | T0 | N1 | M0 |
| T1 | N1 | M0 |
| T2 | N0 | M0 |
IIB | T2 | N1 | M0 |
| T3 | N0 | M0 |
IIIA | T0 | N2 | M0 |
| T1 | N2 | M0 |
| T2 | N2 | M0 |
| T3 | N1 | M0 |
| T3 | N2 | M0 |
IIIB | T4 | N0 | M0 |
| T4 | N1 | M0 |
| T4 | N2 | M0 |
IIIC | Any T | N3 | M0 |
IV | Any T | Any N | M1 |
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Tis N0 M0 | Any | Any | Any | Any | 0 |
T1 N0 M0 T0 N1mi M0 T1 N1mi M0 | G1 | Positive | Positive | Positive | IA |
Negative | |||||
Negative | Positive | ||||
Negative | |||||
Negative | Positive | Positive | |||
Negative | |||||
Negative | Positive | ||||
Negative | IB | ||||
G2 | Positive | Positive | Positive | IA | |
Negative | |||||
Negative | Positive | ||||
Negative | |||||
Negative | Positive | Positive | |||
Negative | |||||
Negative | Positive | ||||
Negative | IB | ||||
G3 | Positive | Positive | Positive | IA | |
Negative | |||||
Negative | Positive | ||||
Negative | |||||
Negative | Positive | Positive | |||
Negative | IB | ||||
Negative | Positive | ||||
Negative | |||||
T0 N1 M0 T1 N1 M0 T2 N0 M0 | G1 | Positive | Positive | Positive | IB |
Negative | IIA | ||||
Negative | Positive | ||||
Negative | |||||
Negative | Positive | Positive | IB | ||
Negative | IIA | ||||
Negative | Positive | ||||
Negative | |||||
G2 | Positive | Positive | Positive | IB | |
Negative | IIA | ||||
Negative | Positive | ||||
Negative | |||||
Negative | Positive | Positive | IB | ||
Negative | IIA | ||||
Negative | Positive | ||||
Negative | IIB | ||||
G3 | Positive | Positive | Positive | IB IIA | |
Negative | |||||
Negative | Positive | ||||
Negative | |||||
Negative | Positive | Positive | |||
Negative | IIB | ||||
Negative | Positive | ||||
Negative | |||||
T2 N1 M0 T3 N0 M0 | G1 | Positive | Positive | Positive | IB |
Negative | IIA | ||||
Negative | Positive | ||||
Negative | IIB | ||||
Negative | Positive | Positive | IIA | ||
Negative | IIB | ||||
Negative | Positive | ||||
Negative | |||||
G2 | Positive | Positive | Positive | IB | |
Negative | IIA | ||||
Negative | Positive | ||||
Negative | IIB | ||||
Negative | Positive | Positive | IIA | ||
Negative | IIB | ||||
Negative | Positive | ||||
Negative | IIIB | ||||
G3 | Positive | Positive | Positive | IB | |
Negative | IIB | ||||
Negative | Positive | ||||
Negative | |||||
Negative | Positive | Positive | |||
Negative | IIIA | ||||
Negative | Positive | ||||
Negative | IIIB | ||||
T0 N2 M0 T1 N2 M0 T2 N2 M0 T3 N1 M0 T3 N2 M0 | G1 | Positive | Positive | Positive | IIA |
Negative | IIIA | ||||
Negative | Positive | ||||
Negative | |||||
Negative | Positive | Positive | IIA | ||
Negative | IIIA | ||||
Negative | Positive | ||||
Negative | IIIB | ||||
G2 | Positive | Positive | Positive | IIA | |
Negative | IIIA | ||||
Negative | Positive | ||||
Negative | |||||
Negative | Positive | Positive | IIA | ||
Negative | IIIA | ||||
Negative | Positive | ||||
Negative | IIIB | ||||
G3 | Positive | Positive | Positive | IIB | |
Negative | IIIA | ||||
Negative | Positive | ||||
Negative | |||||
Negative | Positive | Positive | |||
Negative | IIIB | ||||
Negative | Positive | ||||
Negative | IIIC | ||||
T4 N0 M0 T4 N1 M0 T4 N2 M0 Any T N3 M0 | G1 | Positive | Positive | Positive | IIIA |
Negative | IIIB | ||||
Negative | Positive | ||||
Negative | |||||
Negative | Positive | Positive | |||
Negative | |||||
Negative | Positive | ||||
Negative | IIIC | ||||
G2 | Positive | Positive | Positive | IIIA | |
Negative | IIIB | ||||
Negative | Positive | ||||
Negative | |||||
Negative | Positive | Positive | |||
Negative | |||||
Negative | Positive | ||||
Negative | IIIC | ||||
G3 | Positive | Positive | Positive | IIIB | |
Negative | |||||
Negative | Positive | ||||
Negative | |||||
Negative | Positive | Positive | |||
Negative | IIIC | ||||
Negative | Positive | ||||
Negative | |||||
Any T Any N M1 | Any | Any | Any | Any | IV |
ER=estrogen receptor; PR=progesterone receptor |
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Tis N0 M0 | Any | Any | Any | Any | 0 |
T1 N0 M0 T0 N1mi M0 T1 N1mi M0 | G1 | Positive | Positive | Positive | IA |
Negative | |||||
Negative | Positive | ||||
Negative | |||||
Negative | Positive | Positive | |||
Negative | |||||
Negative | Positive | ||||
Negative | |||||
G2 | Positive | Positive | Positive | ||
Negative | |||||
Negative | Positive | ||||
Negative | |||||
Negative | Positive | Positive | |||
Negative | |||||
Negative | Positive | ||||
Negative | IB | ||||
G3 | Positive | Positive | Positive | IA | |
Negative | |||||
Negative | Positive | ||||
Negative | |||||
Negative | Positive | Positive | |||
Negative | |||||
Negative | Positive | ||||
Negative | IB | ||||
T0 N1 M0 T1 N1 M0 T2 N0 M0 | G1 | Positive | Positive | Positive | IA |
Negative | IB | ||||
Negative | Positive | ||||
Negative | IIA | ||||
Negative | Positive | Positive | IA | ||
Negative | IB | ||||
Negative | Positive | ||||
Negative | IIA | ||||
G2 | Positive | Positive | Positive | IA | |
Negative | IB | ||||
Negative | Positive | ||||
Negative | IIA | ||||
Negative | Positive | Positive | IA | ||
Negative | IIA | ||||
Negative | Positive | ||||
Negative | |||||
G3 | Positive | Positive | Positive | IA IIA | |
Negative | |||||
Negative | Positive | ||||
Negative | |||||
Negative | Positive | Positive | IB | ||
Negative | IIA | ||||
Negative | Positive | ||||
Negative | |||||
T2 N1 M0 T3 N0 M0 | G1 | Positive | Positive | Positive | IA |
Negative | IIB | ||||
Negative | Positive | ||||
Negative | |||||
Negative | Positive | Positive | IA | ||
Negative | IIB | ||||
Negative | Positive | ||||
Negative | |||||
G2 | Positive | Positive | Positive | IB | |
Negative | IIB | ||||
Negative | Positive | ||||
Negative | |||||
Negative | Positive | Positive | IB | ||
Negative | IIB | ||||
Negative | Positive | ||||
Negative | |||||
G3 | Positive | Positive | Positive | IB | |
Negative | IIB | ||||
Negative | Positive | ||||
Negative | |||||
Negative | Positive | Positive | IIA | ||
Negative | IIB | ||||
Negative | Positive | ||||
Negative | IIIA | ||||
T0 N2 M0 T1 N2 M0 T2 N2 M0 T3 N1 M0 T3 N2 M0 | G1 | Positive | Positive | Positive | IB |
Negative | IIIA | ||||
Negative | Positive | ||||
Negative | |||||
Negative | Positive | Positive | IB | ||
Negative | IIIA | ||||
Negative | Positive | ||||
Negative | |||||
G2 | Positive | Positive | Positive | IB | |
Negative | IIIA | ||||
Negative | Positive | ||||
Negative | |||||
Negative | Positive | Positive | IB | ||
Negative | IIIA | ||||
Negative | Positive | ||||
Negative | IIIB | ||||
G3 | Positive | Positive | Positive | IIA | |
Negative | IIIA | ||||
Negative | Positive | ||||
Negative | |||||
Negative | Positive | Positive | IIA | ||
Negative | IIIA | ||||
Negative | Positive | ||||
Negative | IIIC | ||||
T4 N0 M0 T4 N1 M0 T4 N2 M0 Any T N3 M0 | G1 | Positive | Positive | Positive | IIIA |
Negative | IIIB | ||||
Negative | Positive | ||||
Negative | |||||
Negative | Positive | Positive | IIIA | ||
Negative | IIIB | ||||
Negative | Positive | ||||
Negative | |||||
G2 | Positive | Positive | Positive | IIIA | |
Negative | IIIB | ||||
Negative | Positive | ||||
Negative | |||||
Negative | Positive | Positive | IIIA | ||
Negative | IIIB | ||||
Negative | Positive | ||||
Negative | IIIC | ||||
G3 | Positive | Positive | Positive | IIIB | |
Negative | |||||
Negative | Positive | ||||
Negative | |||||
Negative | Positive | Positive | |||
Negative | IIIC | ||||
Negative | Positive | ||||
Negative | |||||
Any T Any N M1 | Any | Any | Any | Any | IV |
ER=estrogen receptor; PR=progesterone receptor |
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Tamoxifen | 20 mg PO every day |
Elacestrant | 345 mg PO every day |
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Aromatase inhibitor | |
Anastrozole | 1 mg PO every day |
Letrozole | 2.5 mg PO every day |
Exemestane | 25 mg PO every day |
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Fulvestrant | 500 mg IM on days 1, 15, 29, and once monthly thereafter |
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Megestrol | 40 mg PO 4 times a day |
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Tamoxifen | 20 mg PO every day |
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Aromatase inhibitor + LHRH* | |
Leuprolide | 7.5 mg IM depot q28d 22.5 mg IM q3mo 30 mg IM q4mo |
Goserelin | 3.6 mg SC depot q28d 10.8 mg SC q3mo |
Megestrol | 40 mg PO 4 times a day |
*LHRH = luteinizing hormone–releasing hormone. |
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Abemaciclib | CDK inhibitor | 200 mg PO BID continue until disease progression | 19.7% | Diarrhea, fatigue, neutropenia and nausea |
Alpelisib | PI3K inhibitor | 300 mg PO qDay continue until disease progression | 26.6% | Hypersensitivity, diarrhea, cutaneous adverse reactions, hyperglycemia |
Capecitabine | Oral fluoro-pyrimidine | 1250 mg/m²/d PO for 2 weeks with 1 wk off | 30% | Rash, hand-foot syndrome, diarrhea, mucositis |
Docetaxel | Antimicrotubule | 75-100 mg/m² IV q3wk or 40 mg/m²/wk X IV for 6 wk with 2 wk off | 30-68% | Myelosuppression, alopecia, skin reaction, mucositis, and fluid retention |
Doxorubicin | Anthracycline (antitumor antibiotic) | 45-60 mg/m² IV q3wk or 20 mg/m² IV qwk (not to exceed a cumulative dose of 450-500 mg/m²) | 35-50% | Myelosuppression, nausea/ vomiting, mucositis, diarrhea cardiotoxicity, alopecia |
Doxil (liposomal encapsulated doxorubicin) | Anthracycline | 20 mg/m² IV q2wk or 35-40 mg/m² IV q4wk |
| Less cardiotoxicity, neutropenia, alopecia, stomatitis, hand-foot syndrome |
Epirubicin | Anthracycline | 90 mg/m² IV q3wk (not to exceed cumulative dose of 900 mg/m²) | 35-50% | Myelosuppression, mucositis, nausea, vomiting, cardiotoxicity |
Everolimus | mTor kinase inhibitor | 10 mg PO qDay continue until disease progression | 12.6% | Stomatitis, constipation, infection, asthenia, fatigue, cough |
Gemcitabine | Antimetabolite | 725 mg/m²/wk IV for 3 wk then 1 wk off or 1 g/m²/wk IV X 2 then 1 wk off |
| Myelosuppression, nausea/ vomiting, flulike syndrome, elevated LFTs |
Nab-paclitaxel | Antimicrotubule | 80-100 mg/m²/wk IV X 3 then 1 wk off or 260 mg/m² IV q3wk | 58-62% 33% | Less neuropathy, and allergic reaction |
Olaparib | PARP inhibitor | 300 mg PO BID | 59.9% | Anemia, fatigue, nausea, and vomiting |
Paclitaxel | Antimicrotubule | 80 mg/m²/wk IV or 175 mg/m² IV over 3 hours q3wk | 25-50% | Myelosuppression, alopecia, neuropathy, allergic reaction |
Pertuzumab | Monoclonal antibody | 840 mg IV loading dose, then 420 mg q3wk Give with trastuzumab and docetaxel | 80.2% (objective response rate) | Fever, allergic reaction, cardiotoxicity/congestive heart failure |
Palbociclib | CDK inhibitor | 125 mg/day PO for 3 weeks with 1 wk off Give with letrozole | Data are not available for ORR Mean PFS was 10.2 months in the letrozole group and 20.2 months for palbociclib plus letrozole group | Neutropenia, leukopenia, thrombocytopenia, anemia, stomatitis |
Ribociclib | CDK inhibitor | 600 mg/day PO for 3 weeks with 1 wk off Give with letrozole | Mean PFS was 16 months in the letrozole group and 25.3 months for ribociclib | QT prolongation, hepatobiliary toxicity, neutropenia, alopecia, diarrhea, vomiting, constipation, fatigue, anorexia |
Sacituzumab govitecan | Monoclonal antibody | 10 mg/kg IV on Days 1 and 8 with 2 wk off | 33.3% | Nausea, neutropenia, diarrhea, fatigue, anemia, vomiting |
Talazoparib | PARP inhibitor | 1 mg PO qDay | 62.6% | Fatigue, anemia, nausea, neutropenia, headache, thrombocytopenia, vomiting, alopecia, diarrhea, and decreased appetite |
Trastuzumab or biosimilars of trastuzumab | Monoclonal antibody | Combination therapy: 4 mg/kg IV once, then 2 mg/kg weekly for 12-18 weeks, then 6 mg/kg q3weeks to total 52 weeks Single agent: 8 mg/kg IV once, then 6 mg/kg q3weeks to total 52 weeks | 10-15% | Fever, allergic reaction, cardiotoxicity/congestive heart failure |
Trastuzumab deruxtecan ] | Monoclonal antibody conjugate | 5.4 mg/kg IV q3weeks | 60.3% | Interstitial lung disease and pneumonitis; neutropenia; left ventricular dysfunction |
Tucatinib ] | Tyrosine kinase inhibitor of HER2 | 300 mg PO BID | 40.6% | Diarrhea, hand-foot syndrome, nausea, fatigue, hepatotoxicity |
Vinorelbine | Vinca alkaloid | 20 mg/m²/wk IV | 35-45% | Myelosuppression, nausea/ vomiting, constipation, fatigue, stomatitis, anorexia |
|
|
|
| ||
Capecitabine Docetaxel | 1250 mg/m² bid days 1-14 75 mg/m² day 1 | Repeat cycle every 21 days May decrease capecitabine dose to 850-1000 mg/m² to reduce toxicity risk |
| ||
Capecitabine Paclitaxel | 825 mg/m² bid days 1-14 175 mg/m² day 1 | Repeat cycle every 21 days |
| ||
Capecitabine Navelbine | 1000 mg/m² bid days 1-14 25 mg/m² days 1 and 8 | Repeat cycle every 21 days |
Gemcitabine ] Paclitaxel | 1250 mg/m² days 1 and 8 175 mg/m² day 1 | Repeat cycle every 21 days |
Carboplatin ] Paclitaxel | AUC of 6 day 1 200 mg/m² day 1 | Repeat cycle every 21 days |
Carboplatin ] Docetaxel | AUC of 6 day 1 75 mg/m² day 1 | Repeat cycle every 21 days |
Palbociclib ] Letrozole | 125 mg PO once daily days 1-21 2.5 mg PO once daily days 1-28 | Repeat cycle every 28 days |
Palbociclib Fulvestrant | 125 mg PO once daily days 1-21 500 mg IM on days 1, 15, 29 and once monthly thereafter | Repeat cycle every 28 days |
Ribociclib ] Letrozole | 600 mg PO once daily days 1-21 2.5 mg PO once daily days 1-28 | Repeat cycle every 28 days |
Paclitaxel ] | 90 mg/m² day 1, 8, and 15 | Repeat cycle every 28 days |
Abemaciclib Fulvestrant ] | 150 mg PO BID 500 mg IM on Days 1, 15 and 29 and once monthly thereafter | Repeat cycle every 28 days |
Ribociclib ] Fulvestrant | 600 mg PO once daily days 1-21 500 mg IM on Days 1, 15 and 29 and once monthly thereafter | Repeat cycle every 28 days |
| ||
Trastuzumab Paclitaxel | 4 mg/kg loading dose then 2 mg/kg weekly 80 mg/m² IV weekly |
|
Trastuzumab Docetaxel | 8 mg/kg loading dose then 6 mg/kg day 1 100 mg/m² IV day 1 | Repeat cycle every 21 days |
Pertuzumab/trastuzumab/hyaluronidase Docetaxel | Loading dose of 1,200 mg pertuzumab/600 mg trastuzumab SC x 1 dose followed by 600 mg pertuzumab/600 mg trastuzumab SC Docetaxel is 75 mg/m IV, may escalate to 100 mg/m | Repeat cycle every 3 week; continue until disease recurrence or unmanageable toxicity, whichever occurs first |
Trastuzumab Vinorelbine | 4 mg/kg loading dose then 2 mg/kg weekly 25 mg/m² day 1 weekly |
|
Trastuzumab Capecitabine Tucatinib ] | 8 mg/kg loading dose then 6 mg/kg weekly 1000 mg/m2 PO BID days 1-14 300 mg PO BID | Repeat cycle every 21 days |
Lapatinib Capecitabine | 1250 mg PO daily 2000 mg/m² daily days 1-14 | Repeat cycle every 21 days |
Paclitaxel Lapatinib | 175 mg/m 1500 mg/d | Repeat cycle every 3 weeks |
AUC = area under the curve (systemic exposure) References for chemotherapy regimens: XT, ] XP, ] XN, ] HER2-positive metastatic breast cancer regimens , , , ] |
|
|
|
History and physical examination | Year 1, every 3-4 mo Year 2, every 4 mo Year 3-5, every 6 mo Year 6+, annually | Year 1-3, every 3-6 mo Year 4-5, every 6-12 mo Year 6+, annually |
Breast self-examination | No recommendation | Counseled to perform monthly breast self-examination |
Mammography | 6 mo after post-BCS radiation therapy Annually thereafter | 6 mo after definitive radiation therapy Every 6-12 mo for surveillance of abnormalities Annually if stability of abnormalities is achieved |
Pelvic examination | Annually, for women on tamoxifen Annual exam if uterus present | Regular gynecologic follow-up Patients on tamoxifen should be advised to report any vaginal bleeding |
Routine blood tests | Not recommended | Not recommended |
Imaging studies | Not recommended | Not recommended |
Tumor marker testing | Not recommended | Not recommended |
Women aged ≥65 years |
Woman aged 60-64 years with ≥1 of the following: 1. Family history of osteoporosis 2. Low body weight 3. Prior nontraumatic fracture 4. Other risk factors (eg, smoking, sedentary lifestyle) |
Postmenopausal women on aromatase inhibitors |
Premenopausal women who develop treatment related premature menopause |
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Contributor Information and Disclosures
Pavani Chalasani, MD, MPH Professor of Medicine, Director, Division of Hematology and Oncology, Leader, Breast Cancer Clinical Research Team, Co-Program Leader, Clinical and Translational Oncology Program, George Washington Cancer Center, George Washington University School of Medicine and Health Sciences Pavani Chalasani, MD, MPH is a member of the following medical societies: American Association for Cancer Research , American College of Physicians , American Society of Clinical Oncology , American Society of Hematology , Hemostasis and Thrombosis Research Society , SWOG Disclosure: Serve(d) as a director, officer, partner, employee, advisor, consultant or trustee for: Bayer, Heron, Amgen, Athenex, Novartis, Eisai, Eli Lilly, Zentalis <br/>Received research grant from: Pfizer.
Abigail Camenisch, BS, MPH MD Candidate, University of Arizona College of Medicine Disclosure: Nothing to disclose.
John V Kiluk, MD, FACS Associate Professor, Department of Oncologic Sciences, Department of Surgery (Joint Appointment), University of South Florida Morsani College of Medicine; Clinical Director, Breast Surgical Oncology, Associate Member, Comprehensive Breast Program, Department of Women's Oncology, H Lee Moffitt Cancer Center and Research Institute John V Kiluk, MD, FACS is a member of the following medical societies: American College of Surgeons , American Society of Breast Surgeons , Moretz Surgical Society, Society of Surgical Oncology , Southeastern Surgical Congress Disclosure: Nothing to disclose.
Alison T Stopeck, MD Professor of Medicine, Arizona Cancer Center, University of Arizona Health Sciences Center; Director of Clinical Breast Cancer Program, Arizona Cancer Center; Medical Director of Coagulation Laboratory, University Medical Center; Director of Arizona Hemophilia and Thrombosis Center Alison T Stopeck, MD is a member of the following medical societies: American Association for Cancer Research , American College of Physicians , American Society of Hematology , SWOG , American Society of Clinical Oncology , Hemophilia and Thrombosis Research Society Disclosure: Received honoraria from Genentech for speaking and teaching; Received honoraria from AstraZeneca for speaking and teaching; Received grant/research funds from AstraZeneca for other.
Patricia A Thompson, PhD Assistant Professor, Department of Pathology, University of Arizona College of Medicine Disclosure: Nothing to disclose.
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Leona Downey, MD is a member of the following medical societies: American Geriatrics Society , American Society of Clinical Oncology , and Southwest Oncology Group
Disclosure: Nothing to disclose.
Manjit Singh Gohel, MD, MRCS, MB, ChB Specialist Registrar, Division of Breast and Endocrine Surgery, Northwick Park Hospital
Harold Harvey, MD Professor, Department of Medicine, Pennsylvania State University
Kanchan Kaur, MBBS, MS (General Surgery), MRCS (Ed) Consulting Breast and Oncoplastic Surgeon, Medanta, The Medicity, India
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Julie Lang, MD is a member of the following medical societies: American College of Surgeons , American Society of Breast Surgeons, American Society of Clinical Oncology , Association for Academic Surgery , and Society of Surgical Oncology
Disclosure: Genomic Health Grant/research funds Speaking and teaching; Agendia Grant/research funds Speaking and teaching; Surgical Tools Grant/research funds Research; Sysmex Grant/research funds Research
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Robert B Livingston, MD is a member of the following medical societies: American Association for Cancer Research , American Federation for Clinical Research, and American Society of Clinical Oncology
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Robert C Shepard, MD, FACP is a member of the following medical societies: American Association for Cancer Research , American College of Physician Executives , American College of Physicians , American Federation for Clinical Research, American Federation for Medical Research , American Medical Association , American Medical Informatics Association , American Society of Hematology , Association of Clinical Research Professionals , Eastern Cooperative Oncology Group , European Society for Medical Oncology , Massachusetts Medical Society , and Society for Biological Therapy
Hemant Singhal, MD, MBBS, FRCSE, FRCS(C) Senior Lecturer, Director of Breast Service, Department of Surgery, Imperial College School of Medicine; Consultant Surgeon, Northwick Park and St Marks Hospitals, UK
Hemant Singhal, MD, MBBS, FRCSE, FRCS(C) is a member of the following medical societies: Royal College of Physicians and Surgeons of Canada and Royal College of Surgeons of Edinburgh
Carl V Smith, MD The Distinguished Chris J and Marie A Olson Chair of Obstetrics and Gynecology, Professor, Department of Obstetrics and Gynecology, Senior Associate Dean for Clinical Affairs, University of Nebraska Medical Center
Carl V Smith, MD is a member of the following medical societies: American College of Obstetricians and Gynecologists , American Institute of Ultrasound in Medicine , Association of Professors of Gynecology and Obstetrics , Central Association of Obstetricians and Gynecologists , Council of University Chairs of Obstetrics and Gynecology , Nebraska Medical Association , and Society for Maternal-Fetal Medicine
Wiley Souba, MD Chairman, Professor, Department of General Surgery, Pennsylvania State College of Medicine; Chief Surgeon, The Milton S Hershey Medical Center
Rachel Swart, MD, PhD Assistant Professor of Medicine, Department of Hematology and Oncology, Arizona Cancer Center, University of Arizona
Rachel Swart, MD, PhD is a member of the following medical societies: American Association for Cancer Research , American Society of Clinical Oncology , Arizona Medical Association , and Southwest Oncology Group
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Clinical depression: what does that mean, what does the term "clinical depression" mean.
Depression ranges in seriousness from mild, temporary episodes of sadness to severe, persistent depression. Clinical depression is the more-severe form of depression, also known as major depression or major depressive disorder. It isn't the same as depression caused by a loss, such as the death of a loved one, or a medical condition, such as a thyroid disorder.
To diagnose clinical depression, many doctors use the symptom criteria for major depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), published by the American Psychiatric Association.
Signs and symptoms of clinical depression may include:
- Feelings of sadness, tearfulness, emptiness or hopelessness
- Angry outbursts, irritability or frustration, even over small matters
- Loss of interest or pleasure in most or all normal activities, such as sex, hobbies or sports
- Sleep disturbances, including insomnia or sleeping too much
- Tiredness and lack of energy, so even small tasks take extra effort
- Reduced appetite and weight loss or increased cravings for food and weight gain
- Anxiety, agitation or restlessness
- Slowed thinking, speaking or body movements
- Feelings of worthlessness or guilt, fixating on past failures or self-blame
- Trouble thinking, concentrating, making decisions and remembering things
- Frequent or recurrent thoughts of death, suicidal thoughts, suicide attempts or suicide
- Unexplained physical problems, such as back pain or headaches
Symptoms are usually severe enough to cause noticeable problems in relationships with others or in day-to-day activities, such as work, school or social activities.
Clinical depression can affect people of any age, including children. However, clinical depression symptoms, even if severe, usually improve with psychological counseling, antidepressant medications or a combination of the two.
Daniel K. Hall-Flavin, M.D.
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- Depression. National Institute of Mental Health. https://www.nimh.nih.gov/health/topics/depression/index.shtml. Accessed April 20, 2017.
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Medical Definition of presenting
Dictionary entries near presenting.
presentation
preservative
Cite this Entry
“Presenting.” Merriam-Webster.com Medical Dictionary , Merriam-Webster, https://www.merriam-webster.com/medical/presenting. Accessed 4 Sep. 2024.
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- Introduction
- Conclusions
- Article Information
a Each excluded patient was recorded as having a single reason on screening logs (eg, “met exclusion criteria”).
b Randomization was stratified according to type of atrial fibrillation (paroxysmal or persistent).
AF indicates atrial fibrillation.
a Mixed models with repeated measures. The geometric mean is on a ratio scale and describes the relative reduction in mean AF at the end point for participants in the ablation group compared with participants in the sham group, accounting for their baseline values. P < .001 for geometric mean difference at 6 months.
AFEQT indicates Atrial Fibrillation Effect on Quality of Life questionnaire; MAFSI, Mayo AF-Specific Symptom Inventory; SF-36, 36-Item Short Form Health Survey. Additional AFEQT and MAFST estimates at 3 months are available in eTables 3-6 and eFigures 4 and 5 in Supplement 2 . AFEQT overall and subscale scores range from 0 to 100. A score of 0 corresponds to complete disability (responding “extremely” limited, difficult, or bothersome to all questions answered), while a score of 100 corresponds to no disability (responding “not at all” limited, difficult, or bothersome to all questions answered). A change of 5 points or greater is considered to be a clinically important difference. MAFSI frequency scores were measured via 5-item Likert scale ranging from 0 (never) to 4 (always) and summed to generate a summary score with a theoretical range from 0 (no atrial fibrillation [AF] symptoms) to 40 (all symptoms constant). MAFSI severity scores were measured via 4-item Likert scale ranging from 0 (never) to 3 (severe) and summed to generate a summary score with a theoretical range from 0 (no AF symptoms) to 30 (all 10 symptoms at the most severe level). Scores for each SF-36 domain range from 0 to 100, with higher scores defining a more favorable health state.
a Mixed models with repeated measures.
Trial Protocol
eTable 1. Implantable loop recorder (Medtronic LINQ) programming settings
eTable 2. Hazard ratios and 95% confidence intervals for time to event outcomes
eFigure 1. Time to any atrial tachyarrhythmia (lasting more than 30 seconds)
eFigure 2. Time to any atrial tachyarrhythmia (lasting more than 7 days)
eFigure 3. Time to any symptomatic atrial tachyarrhythmia (determined by ILR activation only)
eTable 3. AFEQT Overall, Symptoms, Daily Activities, and Treatment Concern Scores in the SHAM-PVI Trial
eFigure 4. Estimated difference of AFEQT scores at 3 months
eTable 4. Estimated difference in AFEQT treatment satisfaction scores at 3 months and 6 months
eTable 5. Individual and total MAFSI frequency scores in the SHAM-PVI Trial
eTable 6. Individual and total MAFSI severity scores in the SHAM-PVI Trial
eFigure 5. Estimated difference of individual MAFSI scores at 3 months
eFigure 6. Estimated difference of individual MAFSI scores at 6 months
eTable 7. 36-Item Short Form Survey (SF-36) Scoring in the SHAM-PVI study
eFigure 7. Estimated difference of SF-36 scores at 3 months
eTable 8 . Number of activations and AF episodes during follow up
eTable 9. EHRA scores at baseline
eTable 10. EHRA scores at 3 months
eTable 11. EHRA scores at 6 months
eTable 12. Healthcare utilisation and medication use in follow-up
eTable 13. Blinding assessment frequency scores and Bang index
Statistical Analysis Plan
Data Sharing Statement
- Pulmonary Vein Isolation With or Without Left Atrial Appendage Ligation in Atrial Fibrillation JAMA Original Investigation April 2, 2024 This multicenter randomized clinical trial examines the effectiveness and safety of left atrial appendage ligation plus pulmonary vein isolation for nonparoxysmal atrial fibrillation treatment. Dhanunjaya R. Lakkireddy, MD; David J. Wilber, MD; Suneet Mittal, MD; David Tschopp, MD; Christopher R. Ellis, MD; Abdi Rasekh, MD; Troy Hounshell, DO; Rudy Evonich, MD; Sheetal Chandhok, MD; Ronald D. Berger, MD, PhD; Rodney Horton, MD; Michael H. Hoskins, MD; Hugh Calkins, MD; Steven J. Yakubov, MD; Pamela Simons, BS; Benjamin R. Saville, PhD; Randall J. Lee, MD, PhD; aMAZE Investigators
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Dulai R , Sulke N , Freemantle N, et al. Pulmonary Vein Isolation vs Sham Intervention in Symptomatic Atrial Fibrillation : The SHAM-PVI Randomized Clinical Trial . JAMA. Published online September 02, 2024. doi:10.1001/jama.2024.17921
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Pulmonary Vein Isolation vs Sham Intervention in Symptomatic Atrial Fibrillation : The SHAM-PVI Randomized Clinical Trial
- 1 Cardiology Research Department, Eastbourne District General Hospital, East Sussex Hospitals NHS Trust, Eastbourne, United Kingdom
- 2 Institute of Cardiovascular Science, University College London, London, United Kingdom
- 3 Mid and South Essex NHS Foundation Trust, Essex Cardiothoracic Centre, Basildon, United Kingdom
- 5 Institute for Clinical Trials and Methodology, University College London, London, United Kingdom
- 6 Circulatory Health Research Group, Medical Technology Research Centre, School of Medicine, Anglia Ruskin University, Chelmsford, United Kingdom
- 7 Nottingham University Hospital NHS Trust, Nottingham, United Kingdom
- Original Investigation Pulmonary Vein Isolation With or Without Left Atrial Appendage Ligation in Atrial Fibrillation Dhanunjaya R. Lakkireddy, MD; David J. Wilber, MD; Suneet Mittal, MD; David Tschopp, MD; Christopher R. Ellis, MD; Abdi Rasekh, MD; Troy Hounshell, DO; Rudy Evonich, MD; Sheetal Chandhok, MD; Ronald D. Berger, MD, PhD; Rodney Horton, MD; Michael H. Hoskins, MD; Hugh Calkins, MD; Steven J. Yakubov, MD; Pamela Simons, BS; Benjamin R. Saville, PhD; Randall J. Lee, MD, PhD; aMAZE Investigators JAMA
Question Does pulmonary vein isolation have a placebo effect in treatment of atrial fibrillation?
Findings In this double-blind randomized trial of 126 patients with symptomatic atrial fibrillation, pulmonary vein isolation resulted in a significant and clinically important decrease in atrial fibrillation burden, with substantial improvements in symptoms and quality of life, compared with a sham procedure.
Meaning Pulmonary vein isolation significantly reduced atrial fibrillation burden compared with a sham control, providing evidence that the benefit of pulmonary vein isolation in symptomatic atrial fibrillation is not because of a placebo effect.
Importance There are concerns that pulmonary vein isolation for atrial fibrillation may have a profound placebo effect, but no double-blind randomized clinical trials have been conducted.
Objective To determine whether pulmonary vein isolation is more effective than a sham procedure for improving outcomes in atrial fibrillation.
Design, Setting, and Participants Double-blind randomized clinical trial conducted at 2 tertiary centers in the UK between January 2020 and March 2024 among patients with symptomatic paroxysmal or persistent atrial fibrillation. Major exclusion criteria included long-standing persistent atrial fibrillation, prior left atrium ablation, other arrhythmias requiring ablative therapy, a left atrium of 5.5 cm or larger, and ejection fraction of less than 35%.
Intervention Participants were randomly assigned to receive pulmonary vein isolation with cryoablation (n = 64) or a sham procedure with phrenic nerve pacing (n = 62).
Main Outcomes and Measures The primary end point was atrial fibrillation burden at 6 months, excluding a 3-month blanking period. Secondary outcomes included quality-of-life measures, time to events, and safety. Atrial fibrillation burden was measured by an implantable loop recorder.
Results A total of 126 participants were randomized (mean age, 66.8 years; 89 men [70.63%]; 20.63% with paroxysmal atrial fibrillation). The absolute mean atrial fibrillation burden change from baseline to 6 months was 60.31% in the ablation group and 35.0% in the sham group (geometric mean difference, 0.25; 95% CI, 0.15-0.42; P < .001). The estimated difference in the overall Atrial Fibrillation Effect on Quality of Life score at 6 months, favoring catheter ablation, was 18.39 points (95% CI, 11.48-25.30 points). The Short Form 36 general health score also improved substantially more with ablation, with an estimated difference of 9.27 points at 6 months (95% CI, 3.78-14.76 points).
Conclusions and Relevance Pulmonary vein isolation resulted in a statistically significant and clinically important decrease in atrial fibrillation burden at 6 months, with substantial improvements in symptoms and quality of life, compared with a sham procedure.
Trial Registration ClinicalTrials.gov Identifier: NCT04272762
Pulmonary vein isolation (PVI) is the standard ablation technique used to treat atrial fibrillation (AF) and currently has a class 1 recommendation for treatment of symptomatic AF when antiarrhythmic medication has failed or patients do not tolerate it. 1 Despite evidence-led indications and previous studies showing that ablation reduces the occurrence of AF and improves quality of life and symptoms, there have been no randomized clinical trials comparing PVI with a sham procedure. 2 , 3
Previous studies of catheter ablation for AF have not shown consistent benefits in end points such as death, stroke, and cardiac arrest. 4 Given these results, there is concern that PVI exhibits a substantial placebo effect that has not been evaluated. 5 , 6 Thus, a sham-controlled trial is warranted to provide conclusive evidence for the efficacy of PVI.
Additionally, previous clinical studies involving a sham procedure have been shown to be safe and feasible and have shown placebo effects of therapy, eg, coronary angioplasty and kidney denervation. 7 , 8 We conducted the SHAM-PVI study to compare the effects of PVI vs a sham procedure on AF burden, quality of life, and symptoms.
The SHAM-PVI study was a dual-center, double-blind randomized clinical trial to evaluate PVI (via cryoballoon ablation) compared with a sham procedure in patients with symptomatic paroxysmal or persistent AF. The trial protocol has been previously published and is available in Supplement 1 . 9 The trial was designed and overseen by a steering committee, sponsored by the East Sussex Healthcare NHS Trust, and conducted in accordance with the Declaration of Helsinki. 10 The trial was approved by the West Midlands–South Birmingham Ethics Committee. An independent data and safety monitoring committee advised the sponsor on safety of participants. A blinded adjudication committee assessed the implantable loop recordings. Written informed consent was obtained from all patients who participated in the study.
Adults with symptomatic paroxysmal or persistent AF despite being treated with at least 1 class I or III antiarrhythmic drug, including β-blockers, or who had antiarrhythmic drug intolerance, and who had been referred for catheter ablation were enrolled in the study. Major exclusion criteria included long-standing persistent AF (any continuous AF episode lasting more than 1 year), prior left atrium catheter or surgical AF ablation, other arrhythmias requiring ablative therapy, left atrium size of 5.5 cm or larger, and ejection fraction of less than 35%.
At enrollment, all patients had a Medtronic Reveal LINQ implantable loop recorder inserted, if one had not been inserted previously, per the manufacturer’s guidelines. The device settings were optimized to record all AF episodes longer than 2 minutes and any tachycardia episode lasting more than 16 beats (eTable 1 in Supplement 2 ). All patients had an implantable loop recorder inserted at least 2 weeks before the day of the main procedure (see footnote to eTable 1 in Supplement 2 ).
Antiarrhythmic medication was discontinued 5 half-lives (up to 5 days) before the procedure day, except for amiodarone, which was discontinued 8 weeks before the procedure day. All procedures were performed using uninterrupted anticoagulation, and all patients continued anticoagulation treatment during the study.
Participants were randomly assigned in a 1:1 ratio to undergo either catheter ablation plus direct current cardioversion (DCCV) if in AF or a sham procedure plus DCCV if in AF. A computerized central blocked randomization design was generated and stratified according to the type of AF (paroxysmal or persistent). Randomization was conducted using a concealed central process. 9
During each procedure, patients were given over-the-ear headphones to play music to prevent hearing communication between the catheter laboratory staff. The patients then underwent sedation during the procedure using opiates and benzodiazepines and had eye coverings provided if necessary. After the procedure, all nursing staff, physicians, and other health care professionals involved in the procedure had no further contact with patients during follow-up. Health care professionals and research staff involved in postprocedure patient care and during follow-up were blinded to the treatment strategy. All patients were discharged with standardized discharge documentation that did not reveal treatment allocation. Participant and staff blinding was assessed at discharge and at 3 and 6 months’ follow-up.
At the beginning of the procedure, 2 right femoral venous access points were established using ultrasound guidance. If a patient was in AF, DCCV was performed to cardiovert to sinus rhythm. Transseptal puncture was performed and PVI was achieved using a Medtronic 28-mm cryoballoon catheter as previously described, with phrenic nerve pacing when ablating the right pulmonary veins. 9 At the end of the procedure, once the sheaths were removed, all patients underwent a 3-way stopcock suture to achieve hemostasis. 11
After 2 right femoral venous access points were established using ultrasound guidance, DCCV was performed if a patient was in AF. A 5F pacing catheter was then placed in the right subclavian vein to pace the phrenic nerves, as described previously. 9 The phrenic nerve were paced for 4 minutes on 4 occasions during the procedure. At the end of the procedure, once sheaths had been removed, all patients underwent a 3-way stopcock suture to achieve hemostasis. 11
Episodes of AF were managed medically per the European Society of Cardiology guidelines during the follow-up phase. 12 Only 1 DCCV was permitted per participant during the follow-up phase. Antiarrhythmic medications were allowed to be restarted depending on the recurrence of AF and symptoms. Antiarrhythmic medications were stopped 5 half-lives before follow-up at 3 months. Use of amiodarone was discouraged. If patients had an alternative indication for β-blocker medications (eg, hypertension or heart failure), they were continued when clinically indicated. Patients underwent scheduled follow-up at 3 and 6 months.
The primary outcome of AF burden was measured using continuous monitoring between the end of month 3 and the end of month 6 postrandomization and compared between the ablation group and sham procedure group. The first 3 months of follow-up were defined as the blanking period, and AF burden and arrhythmia-based outcomes in this period were censored. Baseline AF burden was derived from the implantable loop recorder monitor from the time of insertion until the day of the main procedure.
Prespecified secondary end points included AF symptoms, which were assessed using the Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire, Mayo AF-Specific Symptom Inventory (MAFSI), and European Heart Rhythm Association (EHRA) classification score, with scores compared between baseline, 3 months, and 6 months. Overall quality of life was assessed using the 36-Item Short Form Health Survey (SF-36). Health care use and medication use were also compared between the 2 groups. Secondary arrhythmia-based end points included time to any atrial tachyarrhythmia, stratified by the length of episode (>30 seconds and >7 days), time to symptomatic atrial tachyarrhythmia, and number of atrial tachyarrhythmia episodes (symptomatic and asymptomatic) in the follow-up period. Other end points included serious adverse events and procedural characteristics.
In the calculations of sample size, we estimated the AF burden in the intervention group to be 25% at 6-month follow-up and in the sham procedure group to be 50%, based on previously published data and clinical investigators’ experience. 13 We assumed a standard deviation of 48%. Based on these data and assumptions with 80% power and a 2-sided α = .05, 118 patients were required in total to be recruited. We recruited 140 patients to take into account unexpected methodological challenges and withdrawals, which were minimized by design.
All analyses were based on the intention-to-treat population using available data. Missing data were not input as part of the principal analyses. Data are summarized and presented as means with SDs or medians with IQRs for continuous variables and as absolute numbers and percentages for categorical data.
The primary efficacy end point was evaluated using a generalized mixed repeated-measures model, including baseline and postintervention observations for each participant parameterized to identify the period (baseline or postrandomization) and the randomized condition in the posttreatment period. The stratification factor (persistent vs paroxysmal AF) was included in this and all other statistical models for prespecified outcomes. Within-patient observations were linked with a random intercept term, and the denominator degrees of freedom for the primary analysis were derived from the number of patients rather than the number of observations. 14 It was our expectation from previous experience that the distribution of data would follow a log(e) linear distribution, so the generalized mixed model included the log(e) AF burden. The log(e) AF burden was back-transformed and presented as a geometric mean.
The widths of the 95% CIs were not adjusted for multiple comparisons and should not be used to infer definitive effects of the intervention; instead, inference should be through the primary analysis.
Frequency distribution of patients and staff perception of treatment allocation postprocedure and at 3-month and 6-month follow-up is reported. We used the Bang Index to describe the extent to which blinding appears intact. 15
All analyses were conducted with R version 4.3.1 (R Foundation) and SAS version 9.4 (SAS Institute Inc). Additional details regarding the statistical analyses are provided in Supplement 3 .
One hundred forty patients were enrolled between January 2020 and August 2023. The study was suspended and paused between March 2020 and July 2021 due to COVID-19 restrictions. Thirteen patients recruited between January 2020 and March 2020 were withdrawn from the study due to COVID-19 measures. The primary end-point analysis intention-to-treat population consisted of 123 patients, 62 randomized to receive ablation and 61 randomized to receive the sham procedure ( Figure 1 ). No patients crossed over from the sham group to the ablation group during the trial, and 61 of the 64 randomized to ablation received the treatment. Demographic and clinical characteristics were generally well balanced between the groups ( Table 1 ). Procedural characteristics are shown in Table 2 .
Results for the primary end point of AF burden are summarized in Figure 2 . The absolute change from baseline in AF burden in the ablation group was 60.31% and in the sham procedure group was 35.0% (geometric mean difference, 0.25; 95% CI, 0.15-0.42; P < .001). In patients with persistent AF, there was an absolute reduction of 71.39% in the ablation group and 44.85% in the sham procedure group (geometric mean difference, 0.26; 95% CI, 0.14-0.46). In patients with paroxysmal AF, there was an absolute reduction of 16.13% in the ablation group and an absolute increase of 2.81% in the sham procedure group (geometric mean difference, 0.23; 95% CI, 0.10-0.54). There was a P = .04 for the interaction between ablation and paroxysmal AF (vs persistent AF). Time-to-event hazard ratios and Kaplan-Meier curves are presented in eTable 2 and eFigures 1-3 in Supplement 2 .
The mean AFEQT summary score (range, 0-100; a higher score indicates a lower level of AF-related disability) at baseline was 53.3 (SD, 16.3) points in the ablation group and 51.3 (SD, 18.1) points in the sham procedure group (eTables 3 and 4 in Supplement 2 ). At 6 months, the mean scores were 77.4 (SD, 20.4) points in the catheter ablation group and 58.3 (SD, 25.2) points in the sham procedure group. The estimated difference at 6 months, favoring catheter ablation, was 18.39 points (95% CI, 11.48-25.30 points). All subdomains of the AFEQT were substantially in favor of ablation at 6 months ( Figure 3 A) and at 3 months (eFigure 4 in Supplement 2 ).
The mean MAFSI frequency and severity scores at baseline were 15.5 (SD, 5.8) and 11.3 (SD, 4.8) points in the ablation group and 16.1 (SD, 6.2) and 11.3 (SD, 4.6) points in the sham procedure group. At 6 months, the mean frequency and severity scores in the catheter ablation group were 7.2 (SD, 6.5) and 5.2 (SD, 4.8) points and in the sham procedure group were 13.9 (SD, 7.3) and 10.2 (SD, 5.4) points. The estimated difference in frequency score at 6 months, favoring catheter ablation, was −6.36 points (95% CI, −8.46 to −4.26 points), and the estimated difference in severity score at 6 months, favoring catheter ablation, was −4.84 points (95% CI, −6.43 to −3.26 points) ( Figure 3 B). All subdomain results of the MAFSI frequency and severity scoring are presented in eTables 5 and 6 and eFigures 5 and 6 in Supplement 2 .
The SF-36 general health score improved more in the ablation group than in the sham procedure group ( Figure 3 C; eTable 7 and eFigure 7 in Supplement 2 ). At baseline, the mean scores were 54.2 (SD, 20.1) in the ablation group and 51.4 (SD, 18.6) in the sham procedure group. At 6 months, the means scores improved to 58.3 (SD, 20.3) in the ablation group and decreased to 47.2 (SD, 20.7) in the sham procedure group. The estimated difference at 6 months, favoring catheter ablation, was 9.27 points (95% CI, 3.78-14.76 points). All 7 remaining SF-36 subscales showed substantial improvements with catheter ablation vs the sham procedure, as shown in Figure 3 C.
During follow-up, the numbers of AF episodes and symptomatic AF episodes were lower in the ablation group than in the sham procedure group (eTable 8 in Supplement 2 ). EHRA classification scores are provided in eTables 9-11 in Supplement 2 .
There were no differences in the number of repeat cardioversions between the groups during follow-up (eTable 12 in Supplement 2 ). During the blanking period, 25 (39.7%) and 30 (48.4%) patients underwent repeat DCCV in the ablation and sham procedure groups, respectively. Between 3 and 6 months 33 of 61 patients (54.1%) in the sham procedure group had restarted a class I or III antiarrhythmic medication vs 20 of 62 patients (32.3%) in the ablation group.
Patients’ Bang Index on discharge on the procedure day was 0.016 (95% CI, −0.053 to 0.084) in the ablation group and −0.032 (95% CI −0.095 to 0.030) in the sham procedure group, indicating nearly perfect blinding (eTable 13 in Supplement 2 ). At 6-month follow-up, 24 of 62 patients in the ablation group correctly guessed their treatment allocation, and 8 of 62 patients believed they had a sham procedure (Bang Index, 0.258; 95% CI, 0.091-0.425). In the sham procedure group, 18 of 61 patients correctly guessed their treatment allocation and 11 of 61 patients believed they had undergone an ablation procedure (Bang Index, 0.115; 95% CI, −0.056 to 0.285).
There was 1 serious adverse event in the sham procedure group. One patient randomized to sham procedure died of an intracranial hemorrhage 2 months after their procedure, which was deemed unrelated to the study procedures by the independent data and safety monitoring committee. In the ablation group, 1 patient had pericarditis postprocedure, 1 patient had an aortic pressure tracing on transseptal puncture without further adverse consequence, and 1 patient had transient leg weakness/numbness due to lidocaine.
In this double-blind, sham-controlled, randomized clinical trial of PVI with cryoballoon ablation, there was a significant decrease in AF burden, the primary objective, compared with that in the sham procedure group. In addition, the reduction in AF burden was accompanied by robust and clinically important improvements in symptoms and quality of life.
To date, there have been multiple clinical trials reporting the beneficial effects of PVI using several end points, including AF burden, time to AF, and symptoms. The CIRCA-DOSE study reported significant reductions in AF burden in paroxysmal AF using cryoballoon and radiofrequency technologies, although no group was treated with medical therapy alone. 16 In addition, the CAPTAF trial also reported significant improvements in quality-of-life measures when comparing AF ablation with medical therapy, and also, the CABANA trial reported significant improvements in AF-specific symptoms. 2 , 17 However, to date, all previous trials have not included a group with a sham procedure, raising the possibility of a placebo effect. This trial is the first to compare PVI with a sham procedure. Our findings confirm previous trial results and show that PVI exhibits no clinically relevant placebo effect.
This study shows and confirms a clear direct relationship between AF burden reduction and symptom improvement. This is similar to previous studies, notably CIRCA-DOSE, which indirectly demonstrated an inverse association between AF burden and quality of life, although CIRCA-DOSE did not include a sham procedure group. 18 Changes in AFEQT score of ±5 points have been shown to be associated with clinically important changes in patients’ health status. 19 In this study, we report a robust and clinically important change of 18.39. Atrial fibrillation burden was chosen as the primary outcome in this study as it is directly related to symptom improvement and due to the difficulty in estimating the placebo effect with a quality-of-life measure.
Previous studies examining PVI have had high crossover rates, which affect the interpretation of results. For example, in the CABANA trial, 9% of patients in the ablation group did not undergo ablation and 22.3% of the patients in the medical therapy group underwent ablation. 4 In the CAPTAF trial comparing ablation and antiarrhythmic medications, 8 of 72 participants (10.5%) randomized to antiarrhythmic therapy crossed over to having an ablation. 17 In the current study, there were no crossovers, increasing the validity of the study and highlighting that the improvements seen are solely due to PVI. At the end of follow-up, 58 of 61 patients in the sham procedure group proceeded to ablation treatment.
The SHAM-PVI study reports similar outcomes to that of the APPROVAL study, 20 with significant reductions in recurrence rates in patients randomized to PVI vs those who did not receive PVI. The major strength of this study compared with the APPROVAL study is the inclusion of continuous monitoring to assess outcomes and AF-specific quality-of-life measures that all showed PVI to be favorable to a sham intervention. The APPROVAL study also consisted of a different patient cohort, including patients with cavotricuspid isthmus–dependent atrial flutter, whereas these patients were excluded in the SHAM-PVI study.
In this study, a substantial number of patients underwent repeat cardioversion (25 in the ablation group and 30 in the sham procedure group) during the blanking period because patients were treated without bias with rhythm control intent throughout the study. Despite this, PVI resulted in reductions in AF burden with improvements in quality of life compared with the sham procedure group. Furthermore, there was a numerical increase in the use of class I or III antiarrhythmic medications in the sham procedure group compared with patients randomized to PVI. Reintroduction of antiarrhythmic medications was guided by the European Society of Cardiology guidelines, and it was not mandated to use previously ineffective antiarrhythmic medications.
We assessed patient and staff blinding before discharge on the day of the procedure, which showed nearly perfect blinding in each group. During follow-up, there was loss of blinding in both patient groups, although half of all patients were still unable to guess their treatment allocation. The loss of blinding appeared to be attributable to the clinical effect of the treatment or lack thereof.
Our study has several limitations. First, the study was limited to 6 months. This is shorter than previous clinical trials assessing AF ablation, which typically have a follow-up of at least 1 year; however, the study aim was not to elucidate the long-term effect of AF ablation but rather the placebo effect, if any. There may be regression to the mean with a longer follow-up, but this would not be due to a placebo effect but rather treatment failure due to disease progression or nondurable PVI. Second, the study was limited to PVI only. This is unlikely to affect the results given that additional ablation, including complex fractionated electrogram and linear ablation, has not been shown to be superior to PVI alone in large randomized clinical trials. 21 Despite advances in technology, PVI remains the cornerstone ablation strategy for treatment of symptomatic AF. It would not be expected that PVI with radiofrequency or pulsed-field ablation would have a differing result than that of cryoablation. Third, the study was conducted in only 2 centers.
In conclusion, PVI resulted in a clinically important decrease in AF burden with substantial improvements in symptoms and quality of life compared with a sham procedure. At 6-month follow-up, this study demonstrated no clinically relevant placebo effect with PVI.
Corresponding Authors: Rick A. Veasey, MD, Cardiology Research Department, East Sussex Hospitals NHS Trust, Eastbourne District General Hospital, Kings Drive, Eastbourne BN21 2UD, United Kingdom ( [email protected] ); Rajdip Dulai, MBBS, University College London, 62 Huntley St, London WC1E 6DD, United Kingdom ( [email protected] ).
Accepted for Publication: August 16, 2024.
Published Online: September 2, 2024. doi:10.1001/jama.2024.17921
Author Contributions: Drs Dulai and Veasey had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Dulai, Sulke, Freemantle, Patel, Veasey.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Dulai.
Critical review of the manuscript for important intellectual content: All authors.
Statistical analysis: Dulai, Freemantle, Srinivasan, Veasey.
Obtained funding: Dulai, Veasey.
Administrative, technical, or material support: All authors.
Supervision: Lambiase, Veasey.
Conflict of Interest Disclosures: Dr Sulke reported being a trustee of the Eastbourne Cardiology Research Charity Fund. Dr Freemantle reported receipt of personal fees from the Eastbourne Cardiology Research Charity Fund during the conduct of the study and personal fees from ALK, Sanofi, Gilead, Orion, AstraZeneca, Ipsen, and Vertex outside the submitted work. Dr Lambiase reported receipt of grants and personal fees from Boston Scientific and grants from Abbott. Dr Srinivasan reported receipt of grants from Abbott and Medtronic. Dr Veasey reported receipt of grants from Medtronic. No other disclosures were reported.
Funding/Support: The study was supported by an unrestricted research grant from the Eastbourne Cardiology Research Charity Fund. Unrestricted in-kind support (implantable loop recorder devices) was provided by Medtronic. Dr Lambiase receives support from UCL/UCLH Biomedicine NIHR.
Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication.
Meeting Presentation: This paper was presented at the European Society of Cardiology (ESC) Congress; September 2, 2024; London, United Kingdom.
Data Sharing Statement: See Supplement 4 .
Additional Contributions: We thank Stanislav Hadjivassilev, MBBS, University Hospitals Sussex NHS Foundation Trust, for his assistance in the preparation of the randomization sequences (not compensated), and we also thank the dedicated staff at East Sussex Healthcare NHS Trust and the Mid and South Essex NHS Foundation Trust who supported the study. We thank Steven Podd, MBBS (Royal Devon University Healthcare NHS Foundation Trust), Conn Sugihara, MBBS (Maidstone and Tunbridge Wells NHS Trust), and Senthil Kirubakaran, MD (Portsmouth Hospitals University NHS Trust), who formed the independent data and safety monitoring committee. Drs Podd, Sugihara, and Kirubakaran received no compensation. During the course of the study, Stephen S. Furniss, FRCP, who was part of the steering committee and blinded adjudication committee, unexpectedly passed away on May 14, 2022. Dr Furniss was a pioneer in the field of electrophysiology and trained many of the electrophysiologists in the UK. He was previously president of the British Heart Rhythm Society. Without his input, guidance, and supervision the study would not have been possible.
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Whole Person Health: What It Is and Why It's Important
.header_greentext{color:greenimportant;font-size:24pximportant;font-weight:500important;}.header_bluetext{color:blueimportant;font-size:18pximportant;font-weight:500important;}.header_redtext{color:redimportant;font-size:28pximportant;font-weight:500important;}.header_darkred{color:#803d2fimportant;font-size:28pximportant;font-weight:500important;}.header_purpletext{color:purpleimportant;font-size:31pximportant;font-weight:500important;}.header_yellowtext{color:yellowimportant;font-size:20pximportant;font-weight:500important;}.header_blacktext{color:blackimportant;font-size:22pximportant;font-weight:500important;}.header_whitetext{color:whiteimportant;font-size:22pximportant;font-weight:500important;}.header_darkred{color:#803d2fimportant;}.green_header{color:greenimportant;font-size:24pximportant;font-weight:500important;}.blue_header{color:blueimportant;font-size:18pximportant;font-weight:500important;}.red_header{color:redimportant;font-size:28pximportant;font-weight:500important;}.purple_header{color:purpleimportant;font-size:31pximportant;font-weight:500important;}.yellow_header{color:yellowimportant;font-size:20pximportant;font-weight:500important;}.black_header{color:blackimportant;font-size:22pximportant;font-weight:500important;}.white_header{color:whiteimportant;font-size:22pximportant;font-weight:500important;} what is whole person health.
Whole person health involves looking at the whole person—not just separate organs or body systems—and considering multiple factors that promote either health or disease. It means helping and empowering individuals, families, communities, and populations to improve their health in multiple interconnected biological, behavioral, social, and environmental areas. Instead of just treating a specific disease, whole person health focuses on restoring health, promoting resilience, and preventing diseases across a lifespan.
![what is a clinical presentation in medical terms Multilevel Whole Person Health Framework](https://files.nccih.nih.gov/multilevel-whole-person-health-framework.png)
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Health and disease are not separate, disconnected states but instead occur on a path that can move in two different directions, either toward health or toward disease.
On this path, many factors, including one’s biological makeup; some unhealthy behaviors, such as poor diet, sedentary lifestyle, chronic stress, and poor sleep; as well as social aspects of life—the conditions in which people are born, grow, live, work, and age—can lead to chronic diseases of more than one organ system. On the other hand, self-care, lifestyle, and behavioral interventions may help with the return to health.
Chronic diseases, such as diabetes, cardiovascular disease, obesity, and degenerative joint disease, can also occur with chronic pain, depression, and opioid misuse—all conditions exacerbated by chronic stress. Some chronic diseases increase the immediate and long-term risks with COVID-19 infection. Understanding the condition in which a person has lived, addressing behaviors at an early stage, and managing stress can not only prevent multiple diseases but also help restore health and stop the progression to disease across a person’s lifespan.
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Some health care systems and programs are now focusing more on whole person health.
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The VA’s Whole Health System of Care and Whole Health approach aims to improve the health and well-being of veterans and to address lifestyle and environmental root causes of chronic disease. The approach shifts from a disease-centered focus to a more personalized approach that engages and empowers veterans early in and throughout their lives to prioritize healthy lifestyle changes in areas like nutrition, activity, sleep, relationships, and surroundings. Conventional testing and treatment are combined with complementary and integrative health approaches that may include acupuncture, biofeedback, massage therapy, yoga, and meditation.
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The Total Force Fitness program arose within the U.S. Department of Defense Military Health System in response to the need for a more holistic approach—a focus on the whole person instead of separate parts or only symptoms—to the demands of multiple deployments and the strains on the U.S. Armed Forces and their family members. The focus extends the idea of total fitness to include the health, well-being, and resilience of the whole person, family, community, and U.S. military.
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Established in 2020, the Whole Health Institute’s Whole Health model helps people identify what matters most to them and build a plan for their journey to whole health. The model provides tools to help people take good care of their body, mind, and spirit, and involves working with a health care team as well as tapping into the support of family, friends, and communities.
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The North Carolina Department of Health and Human Services has incorporated a whole person health approach into its health care system by focusing on integrating physical, behavioral, and social health. The state has taken steps to encourage collaborative behavioral health care and help resolve widespread inequities in social conditions, such as housing and nutritious food access.
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The Ornish Program for Reversing Heart Disease is an intensive cardiac rehabilitation program that has been shown to reverse the progression of coronary heart disease through lifestyle changes, without drugs or surgery. The program is covered by Medicare and some health insurance companies. The program’s lifestyle changes include exercise, smoking cessation, stress management, social support, and a whole-foods, plant-based diet low in total fat. The program is offered by a team of health care professionals who provide the support that individuals need to make and maintain lasting changes in lifestyle.
.header_greentext{color:green!important;font-size:24px!important;font-weight:500!important;}.header_bluetext{color:blue!important;font-size:18px!important;font-weight:500!important;}.header_redtext{color:red!important;font-size:28px!important;font-weight:500!important;}.header_darkred{color:#803d2f!important;font-size:28px!important;font-weight:500!important;}.header_purpletext{color:purple!important;font-size:31px!important;font-weight:500!important;}.header_yellowtext{color:yellow!important;font-size:20px!important;font-weight:500!important;}.header_blacktext{color:black!important;font-size:22px!important;font-weight:500!important;}.header_whitetext{color:white!important;font-size:22px!important;font-weight:500!important;}.header_darkred{color:#803d2f!important;}.Green_Header{color:green!important;font-size:24px!important;font-weight:500!important;}.Blue_Header{color:blue!important;font-size:18px!important;font-weight:500!important;}.Red_Header{color:red!important;font-size:28px!important;font-weight:500!important;}.Purple_Header{color:purple!important;font-size:31px!important;font-weight:500!important;}.Yellow_Header{color:yellow!important;font-size:20px!important;font-weight:500!important;}.Black_Header{color:black!important;font-size:22px!important;font-weight:500!important;}.White_Header{color:white!important;font-size:22px!important;font-weight:500!important;} What does research show about whole person health?
A growing body of research suggests the benefits of healthy behaviors, environments, and policies to maintain health and prevent, treat, and reverse chronic diseases. This research includes several large, long-term epidemiological studies—such as the Framingham Heart Study, Nurses’ Health Study, and Adventist Health Studies—that have evaluated the connections between lifestyle, diet, genetics, health, and disease.
There is a lack, however, of randomized controlled trials and other types of research on multicomponent interventions and whole person health. Challenges come with conducting this type of research and with finding appropriate ways to assess the evidence. But opportunities are emerging to explore new paths toward reliable and rigorous research on whole person health.
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Yes, NCCIH plans to fund research on whole person health . (Details can be found in the NCCIH Strategic Plan FY 2021–2025: Mapping a Pathway to Research on Whole Person Health . )
By deepening the scientific understanding of the connections that exist across the different areas of human health, researchers can better understand how conditions interrelate, identify multicomponent interventions that address these problems, and determine the best ways to support individuals through the full continuum of their health experience, including the return to health.
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Nccih clearinghouse.
The NCCIH Clearinghouse provides information on NCCIH and complementary and integrative health approaches, including publications and searches of Federal databases of scientific and medical literature. The Clearinghouse does not provide medical advice, treatment recommendations, or referrals to practitioners.
Toll-free in the U.S.: 1-888-644-6226
Telecommunications relay service (TRS): 7-1-1
Website: https://www.nccih.nih.gov
Email: [email protected] (link sends email)
Know the Science
NCCIH and the National Institutes of Health (NIH) provide tools to help you understand the basics and terminology of scientific research so you can make well-informed decisions about your health. Know the Science features a variety of materials, including interactive modules, quizzes, and videos, as well as links to informative content from Federal resources designed to help consumers make sense of health information.
Explaining How Research Works (NIH)
Know the Science: How To Make Sense of a Scientific Journal Article
Understanding Clinical Studies (NIH)
A service of the National Library of Medicine, PubMed® contains publication information and (in most cases) brief summaries of articles from scientific and medical journals. For guidance from NCCIH on using PubMed, see How To Find Information About Complementary Health Approaches on PubMed .
Website: https://pubmed.ncbi.nlm.nih.gov/
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- Aggarwal M, Ornish D, Josephson R, et al. Closing gaps in lifestyle adherence for secondary prevention of coronary heart disease. American Journal of Cardiology. 2021;145:1-11.
- Centers for Medicare & Medicaid Services. Decision Memo for Intensive Cardiac Rehabilitation (ICR) Program—Dr. Ornish’s Program for Reversing Heart Disease (CAG-00419N). Accessed at https://www.cms.gov/ on April 26, 2021.
- Deuster PA, O’Connor FG. Human performance optimization: culture change and paradigm shift. Journal of Strength and Conditioning Research. 2015;29(suppl 11):S52-S56.
- Gaudet T, Kligler B. Whole health in the whole system of the Veterans Administration: how will we know we have reached this future state? Journal of Alternative and Complementary Medicine. 2019;25(S1):S7-S11.
- Malecki HL, Gollie JM, Scholten J. Physical activity, exercise, whole health, and integrative health coaching. Physical Medicine and Rehabilitation Clinics of North America. 2020;31(4):649-663.
- National Center for Complementary and Integrative Health. NCCIH Strategic Plan FY 2021–2025: Mapping a Pathway to Research on Whole Person Health. National Center for Complementary and Integrative Health website. Accessed at https://www.nccih.nih.gov/about/nccih-strategic-plan-2021-2025 on May 14, 2021.
- North Carolina Department of Health and Human Services website. Healthy Opportunities and Medicaid Transformation. Accessed at https://www.ncdhhs.gov/about/department-initiatives/healthy-opportunities/healthy-opportunities-pilots/healthy on April 26, 2021.
- Military Health System website. Total Force Fitness. Accessed at https://health.mil/Military-Health-Topics/Total-Force-Fitness on April 26, 2021.
- Tilson EC, Muse A, Colville K, et al. Investing in whole person health: working toward an integration of physical, behavioral, and social health. North Carolina Medical Journal. 2020;81(3):177-180.
- U.S. Department of Veterans Affairs website. Whole Health. Accessed at https://www.va.gov/wholehealth/ on April 26, 2021.
- U.S. Department of Veterans Affairs website. Whole Health Library. Accessed at https://www.va.gov/wholehealthlibrary/ on April 26, 2021.
- Vodovotz Y, Barnard N, Hu FB, et al. Prioritized research for the prevention, treatment, and reversal of chronic disease: recommendations from the Lifestyle Medicine Research Summit. Frontiers in Medicine (Lausanne). 2020;7:585744.
- Whitehead AM, Kligler B. Innovations in care: complementary and integrative health in the Veterans Health Administration Whole Health System. Medical Care. 2020;58(9S)(suppl 2):S78-S79.
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- Bisht K, Sharma K, Tremblay M-È. Chronic stress as a risk factor for Alzheimer's disease: roles of microglia-mediated synaptic remodeling, inflammation, and oxidative stress. Neurobiology of Stress. 2018;9:9-21.
- Buettner D, Skemp S. Blue Zones: lessons from the world’s longest lived. American Journal of Lifestyle Medicine. 2016;10(5):318-321.
- Chen T-L, Chang S-C, Hsieh H-F, et al. Effects of mindfulness-based stress reduction on sleep quality and mental health for insomnia patients: a meta-analysis. Journal of Psychosomatic Research. 2020;135:110144.
- Conversano C, Orrù G, Pozza A, et al. Is mindfulness-based stress reduction effective for people with hypertension? A systematic review and meta-analysis of 30 years of evidence. International Journal of Environmental Research and Public Health. 2021;18(6):2882.
- Katz DL, Karlsen MC, Chung M, et al. Hierarchies of evidence applied to lifestyle medicine (HEALM): introduction of a strength-of-evidence approach based on a methodological systematic review. BMC Medical Research Methodology. 2019;19(1):178.
- Kruk J, Aboul-Enein BH, Bernstein J, et al. Psychological stress and cellular aging in cancer: a meta-analysis. Oxidative Medicine and Cellular Longevity. 2019;2019:1270397.
- Levesque C. Therapeutic lifestyle changes for diabetes mellitus. Nursing Clinics of North America. 2017;52(4):679-692.
- Ni Y, Ma L, Li J. Effects of mindfulness-based stress reduction and mindfulness-based cognitive therapy in people with diabetes: a systematic review and meta-analysis. Journal of Nursing Scholarship. 2020;52(4):379-388.
- Ornish Lifestyle Medicine website. The Ornish Reversal Program: Intensive Cardiac Rehabilitation. Accessed at https://www.ornish.com/intensive-cardiac-rehab/ on April 26, 2021.
- Schneiderman N, Ironson G, Siegel SD. Stress and health: psychological, behavioral, and biological determinants. Annual Review of Clinical Psychology. 2005;1:607-628.
- Seal KH, Becker WC, Murphy JL, et al. Whole Health Options and Pain Education (wHOPE): a pragmatic trial comparing whole health team vs primary care group education to promote nonpharmacological strategies to improve pain, functioning, and quality of life in veterans—rationale, methods, and implementation. Pain Medicine. 2020;21(suppl 2):S91-S99.
- Tamashiro KL, Sakai RR, Shively CA, et al. Chronic stress, metabolism, and metabolic syndrome. Stress. 2011;14(5):468-474.
- Whayne TF Jr, Saha SP. Genetic risk, adherence to a healthy lifestyle, and ischemic heart disease. Current Cardiology Reports. 2019;21(1):1.
- Whole Health Institute website. Accessed at https://www.wholehealth.org/ on May 19, 2021.
Acknowledgments
NCCIH thanks Mary Beth Kester, M.S., and Helene M. Langevin, M.D., NCCIH, for their review of this publication.
This publication is not copyrighted and is in the public domain. Duplication is encouraged.
NCCIH has provided this material for your information. It is not intended to substitute for the medical expertise and advice of your health care provider(s). We encourage you to discuss any decisions about treatment or care with your health care provider. The mention of any product, service, or therapy is not an endorsement by NCCIH.
Related Topics
NCCIH Strategic Plan FY 2021–2025 Mapping a Pathway to Research on Whole Person Health
Methodological Approaches for Whole Person Research Workshop
Transforming Veterans’ Health: Implementing a Whole Health System of Care
Complementary, Alternative, or Integrative Health: What’s In a Name?
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Bayer to unveil new data from its Phase III OASIS 3 long-term study of elinzanetant in the treatment of vasomotor symptoms associated with menopause
Not intended for uk media – the menopause society annual meeting 2024:.
Detailed results from the Phase III OASIS 3 study evaluating the efficacy and long-term safety of investigational compound elinzanetant will be presented for the first time at this year’s Annual Meeting of The Menopause Society (TMS) / First presentation of pooled efficacy analysis from pivotal Phase III studies OASIS 1 and 2 / Elinzanetant is the first dual neurokinin-1 and 3 (NK-1 and 3) receptor antagonist being studied for the non-hormonal treatment of moderate to severe VMS associated with menopause, administered orally once daily
Berlin, September 4, 2024 – Bayer will present detailed results from the Phase III long-term study OASIS 3, evaluating the efficacy and long-term safety of the investigational compound elinzanetant versus placebo, at the upcoming annual meeting of The Menopause Society (TMS) which takes place from September 10 – 14, in Chicago, IL, United States. Additional elinzanetant presentations include pooled efficacy results from the pivotal Phase III studies OASIS 1 and 2, which will be presented for the first time during the meeting.
OASIS 1, 2 and 3 data presentations:
· Poster #121 : “Efficacy and Long-term Safety of Elinzanetant for the Treatment of VMS Associated with Menopause: A Phase 3 Randomized Trial (OASIS 3)”
o Nick Panay o Thursday, September 12, 06:15 PM to 7:15 PM CDT, Location: Riverside East, Riverside West/South – Exhibit Hall Level- East Tower
· Oral presentation: “Efficacy Of Elinzanetant for the treatment of vasomotor symptoms associated with menopause: pooled data from two Phase 3 studies”
o James A Simon; MD o Thursday, September 12, 5:00 PM to 5:15 PM CDT, Location: Grand Ballroom – Ballroom Level - East Tower
Additional Bayer presentations include:
· Poster #117: “Clinically meaningful improvements in vasomotor symptoms, sleep and quality of life of postmenopausal women: thresholds derived from OASIS-2 data”
o Christian Seitz o Thursday, September 12, 06:15 PM to 7:15 PM CDT, Location: Riverside East, Riverside West/South – Exhibit Hall Level- East Tower
· Poster #122: “Do sleep disturbances have an impact on depression and anxiety in perimenopausal and postmenopausal women? A US-based Survey”
o Claudio N Soares, MD o Thursday, September 12, 06:15 PM to 7:15 PM CDT, Location: Riverside East, Riverside West/South – Exhibit Hall Level- East Tower
· Poster #116: “Design of NIRVANA: a phase 2 pilot trial to assess the efficacy of elinzanetant for the treatment of sleep disturbances associated with menopause”
· Poster #37: “ The effects of elinzanetant on simulated driving performance in healthy women: a phase I study”
o Senka Djordjevic o Thursday, September 12, 06:15 PM to 7:15 PM CDT, Location: Riverside East, Riverside West/South – Exhibit Hall Level- East Tower
· Educational Session: “Dishing on Menopause: An Invitation to Listen”
o Donna Klassen, Wendee Lee Curtis and Susan LaPlae Miller o Thursday, September 12, 4:30 to 5:00 PM CDT, Location: Grand Hall G to I – Ballroom Level – East Tower
Elinzanetant is the first dual neurokinin-1 and 3 (NK-1 and 3) receptor antagonist in late-stage clinical development for the non-hormonal treatment of moderate to severe VMS associated with menopause. Results from the OASIS 1 and 2 studies were recently published in The Journal of the American Medical Association (JAMA) 1 . Based on positive results from OASIS 1, 2 and 3, Bayer has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for elinzanetant for the treatment of moderate to severe VMS associated with menopause. Bayer will submit applications for marketing authorizations of elinzanetant to other health authorities as well.
About the OASIS 1, 2 and 3 studies
OASIS 1 and 2 (NCT05042362 and NCT05099159) are double-blind, randomized, placebo-controlled multicenter studies investigating the efficacy and safety of elinzanetant administered orally once daily in women with moderate to severe VMS associated with menopause over 26 weeks. OASIS 1 and 2 randomized 396 and 400 postmenopausal women between 40 and 65 years across 184 sites in 15 countries. Patients in the elinzanetant arm received a 120 mg dose of elinzanetant once daily for 26 weeks and patients in the control arm received a matching placebo once daily for 12 weeks, followed by elinzanetant 120 mg dose for 14 weeks. OASIS 3 (NCT05030584) is a double-blind, randomized, placebo-controlled multicenter study to investigate the efficacy and safety of elinzanetant for the treatment of vasomotor symptoms over 52 weeks in postmenopausal women. OASIS 3 randomized 628 postmenopausal women between 40 and 65 years across 83 sites in 9 countries.
About the Elinzanetant clinical development program
The Phase III clinical development program of elinzanetant, OASIS, currently comprises four Phase III studies: OASIS 1, 2, 3 and 4. The OASIS 1, 2 and 3 studies investigate the efficacy and safety of elinzanetant 120 mg in women with moderate to severe VMS associated with menopause. The OASIS 4 study is an expansion of the clinical Phase III program and investigates the efficacy and safety of elinzanetant in women with moderate to severe VMS caused by endocrine therapy for treatment or prevention of breast cancer.
The design and dosing of the Phase III clinical development program is based on the positive data from two Phase II studies (RELENT-1 and SWITCH-1). RELENT-1 was a Phase Ib/IIa study investigating the safety, pharmacokinetics and preliminary efficacy of elinzanetant. SWITCH-1 was a Phase IIb study investigating the efficacy and safety of four different doses of elinzanetant compared to placebo in women with VMS.
In addition to the OASIS program, Bayer is conducting NIRVANA (NCT06112756), an exploratory Phase II randomized, parallel-group treatment, double-blind study. The primary objective is to explore the efficacy of elinzanetant on sleep disturbances associated with menopause as determined by polysomnography (PSG). PSG is a validated method to study sleep and underlying causes of sleep disturbances. Additional objectives include exploring the efficacy of elinzanetant on SDM as determined by patient-reported outcomes and further evaluating the safety of elinzanetant.
About Elinzanetant Elinzanetant is the first dual neurokinin-1 and 3 (NK-1 and 3) receptor antagonist, in late-stage clinical development for the non-hormonal treatment of moderate to severe VMS associated with menopause, administered orally once daily. Elinzanetant may address moderate to severe VMS by modulating a group of estrogen sensitive neurons in the hypothalamus region of the brain (the KNDy neurons) which, with the decrease of estrogen, become hypertrophic and lead to a hyperactivation of the thermoregulatory pathway, consequently disrupting body heat control mechanisms resulting in VMS. Elinzanetant may also decrease sleep disturbances associated with menopause.
About Vasomotor Symptoms Vasomotor symptoms (VMS; also referred to as hot flashes) result from hyperactivation of the thermoregulatory pathway mediated by hypertrophy of the KNDy neurons. This is due to a decrease of estrogen, which can result from the progressive reduction of ovarian function due to natural menopause or medical intervention by bilateral oophorectomy or endocrine therapy.
VMS are reported by up to 80% of women at some point during the menopausal transition and are one of the leading causes for seeking medical attention during this phase of a woman’s life. Over one-third of menopausal women report severe symptoms, which can last 10 years or more after the last menstrual period, with relevant impact on quality of life.
VMS may also be caused by endocrine therapy, for the treatment or prevention of breast cancer, impacting quality of life and treatment adherence. For these women, there are currently no approved treatment options.
About Menopause By 2030, the global population of women experiencing menopause is projected to increase to 1.2 billion, with 47 million women entering this phase each year. Menopause is a transitional phase in women’s lives, related to the progressive decline of ovarian function. It usually occurs in women during their 40s or early 50s. It can also be the result of surgical or medical treatment such as breast cancer treatment. The hormonal decline can lead to various symptoms which can substantially affect a woman’s health, quality of life, healthcare utilization and work productivity. The most frequently reported and disruptive symptoms during the menopausal transition are VMS, sleep disturbances and mood changes. Addressing these symptoms is key to maintaining functional ability and quality of life in menopause which is highly relevant from both a healthcare and socio-economic perspective.
About Women’s Healthcare at Bayer Women’s Health is in Bayer’s DNA. As a global leader in women’s healthcare Bayer has a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. Bayer offers a wide range of effective short- and long-acting birth control methods as well as therapies for menopause management and gynecological diseases. Bayer is also focusing on innovative options to address the unmet medical needs of women worldwide and to broadening treatment choices such as in menopause. Additionally, Bayer intends to provide 100 million women per year in low-and-middle income countries by 2030 with access to family planning by funding multi-stakeholder aid programs for capacity building and by ensuring the supply of affordable modern contraceptives. This is part of the comprehensive sustainability measures and commitments from 2020 onwards and in line with the Sustainable Development Goals of the United Nations.
About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to www.bayer.com .
ind more information at https://pharma.bayer.com Follow us on Facebook: http://www.facebook.com/bayer Follow us on LinkedIn: Bayer | Pharmaceuticals
Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com . The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
Contact for global media inquiries: Katja Wiggers, phone +49 30 221541614 Email: [email protected]
Contact for US media inquiries: Courtney Ambrosi, phone 1 (908) 798-1107 Email: [email protected]
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Presentation
Different Types of Slides for Your Presentations
![what is a clinical presentation in medical terms Different Types of Slides for Your Presentations](https://cdn.slidesai.io/cdn-cgi/image/width=1920/https://cms-media.slidesai.io/wp-content/uploads/2024/09/03143733/Types-of-Slides.png)
Table of Contents
Presentations are a great way to share information and ideas. Whether you’re selling a product, teaching a class, or showing off your work, the slides you use can make a big difference.
There are many different kinds of slides you can add to your presentations, each with its own purpose and advantages. By knowing the different types of slides and how to use them well, you can create interesting and informative presentations that will stick with your audience.
Different Types of Slides
There are many different types of slides that you can use in your presentations. Some of the most common types include:
Opening Slides
1. title slide.
![what is a clinical presentation in medical terms title slide](https://cdn.slidesai.io/cdn-cgi/image/width=2048/https://cms-media.slidesai.io/wp-content/uploads/2024/09/03151051/title-slide.png)
The title slide is your chance to make a strong first impression and set the tone for your presentation. It should clearly convey the topic, your identity, and relevant details. A good title is both practical and creative.
The main title is the focal point and should be concise yet descriptive. Use a large font size that’s easy to read from a distance. If needed, add a subtitle for more context. Clearly state your name, job title, and affiliation. Include the date and venue for reference.
Design your slide to reflect your brand or personal style using logos, colors, and fonts. Keep it clean and uncluttered for a professional look. Remember, less is more. Use high contrast for readability and avoid distracting background images. Consider adding subtle effects like fade-in or morph for visual interest.
2. Agenda Slide
![what is a clinical presentation in medical terms agenda slide](https://cdn.slidesai.io/cdn-cgi/image/width=2048/https://cms-media.slidesai.io/wp-content/uploads/2024/09/03151116/agenda-slide.png)
Agenda slides serve as a valuable tool for guiding your audience through the structure of your presentation. By outlining the main topics and their expected duration, you can help them anticipate the flow of information and manage their expectations.
This is especially beneficial for lengthy presentations or academic talks where a clear roadmap can enhance understanding and engagement.
When creating an agenda slide, consider including the following elements:
- Clear Topic List: Present a concise and well-organized list of the main topics to be covered.
- Optional Timings: Indicate the estimated duration of each section to provide a sense of pacing.
- Visual Progress Indicator: Use checkmarks, arrows, or other visual cues to highlight the current topic and show what’s ahead.
- Distinctive Headings: Use clear and concise headings to visually separate different sections.
- Hyperlink Integration: If using PowerPoint, consider adding hyperlinks to specific slides to ensure smooth navigation and avoid abrupt jumps.
Learn more on How to Create Agenda Slides in Powerpoint .
Transitional Slides
Transitional slides act like bridges that connect different parts of your presentation. They help your audience smoothly move from one topic to the next. These slides are important because they:
- Clearly Signal a Change: Let your audience know that you’re moving on to something new.
- Keep the Audience Engaged: Prevent sudden jumps between topics, helping them stay focused.
- Make Your Presentation More Visually Interesting: Add variety and visual appeal.
Here are some examples of transitional slides:
3. Quote Slide
![what is a clinical presentation in medical terms quote slide](https://cdn.slidesai.io/cdn-cgi/image/width=2048/https://cms-media.slidesai.io/wp-content/uploads/2024/09/03151127/quote-slide.png)
Quote slides incorporate wisdom, authority, or inspiration from renowned sources into your presentations. They can provide strong support for your arguments or motivate your audience.
These slides are perfect for emphasizing a point, sparking thought, or introducing a new direction in your presentation. Use them to highlight the importance of an idea.
Here are the elements of a quote slide:
- The Quote: Clearly presented and attributed to the speaker or writer. The text should be easy to read and emphasized to stand out.
- Author’s Name and Credentials: Provide context by including the author’s name and, if relevant, their qualifications or why they are an expert on the topic.
- Related Imagery or Background: An image or design that matches the theme of the quote can make it more impactful.
Consider using a quote presentation template with a professional layout. You can find something directly on SlidesAI . For readability, ensure there is a good contrast between the text and the background. Text boxes with backgrounds are often used. If you use an image, choose one that enhances the text, not competes with it.
4. Image Slides
![what is a clinical presentation in medical terms image slide](https://cdn.slidesai.io/cdn-cgi/image/width=2048/https://cms-media.slidesai.io/wp-content/uploads/2024/09/03151146/image-slide.png)
Image slides can significantly make your presentations better by gaining attention with their visual appeal and transitions. For a smooth flow, use a full-screen image with a fade effect. To create a more dynamic experience, experiment with the Morph transition between slides featuring overlapping images.
You can also build anticipation with a thematic image series that subtly connects your topics. Remember to keep these transitions concise and impactful to maintain your audience’s attention.
Closing Slides
5. q&a slide.
![what is a clinical presentation in medical terms q and a slide](https://cdn.slidesai.io/cdn-cgi/image/width=2048/https://cms-media.slidesai.io/wp-content/uploads/2024/09/03151203/q-and-a-slide.png)
Q&A slides are often used in presentations for various reasons. For instance, some presenters like to ask questions to the audience after their presentation and answer any questions they may have.
Other presentations might encourage the audience or panel members to ask questions throughout the presentation. If you’re planning to incorporate Q&A into your presentation, consider using some well-designed templates to make a positive impression.
6. CTA Slides
![what is a clinical presentation in medical terms CTA slide](https://cdn.slidesai.io/cdn-cgi/image/width=2048/https://cms-media.slidesai.io/wp-content/uploads/2024/09/03151214/CTA-slide.png)
A call-to-action slide, or CTA slide for short, serves to encourage viewers to take a specific step after your presentation. This could range from initiating a conversation to purchasing a product or service, or even engaging in a project.
Typically placed at the end, following the concluding remarks and thank you slide, the CTA aims to spark immediate action. Here’s what makes a strong CTA slide:
- A Clear Direction: The heart of the CTA itself should be direct and persuasive. Think of something like “Register Now,” “Join Our Team,” or “Visit Us Online.”
- Reasons to Act: Briefly remind viewers of the benefits they reap by taking action. This strengthens the appeal and motivates them to follow through.
- Contact Information or Links: Make it easy for them to act! Include all necessary links or contact details so viewers know exactly where to go next.
- Visually Appealing Design: Grab their attention! Use a design that pops and features large, easy-to-read text. Opt for strong, action-oriented language to drive the message home.
7. Summary Slide
![what is a clinical presentation in medical terms summary slide](https://cdn.slidesai.io/cdn-cgi/image/width=2048/https://cms-media.slidesai.io/wp-content/uploads/2024/09/03151227/summary-slide.png)
A summary slide is a great way to give your viewers an overview of the presentation once it ends. By recapping everything that was presented, summary slides make it easier to remember the most important takeaways.
A summary slide should include:
- Important Points: Clearly summarize the main points covered in your presentation.
- Visual Recap: Use simple visuals like graphics, charts, or callouts to visually represent significant data or conclusions.
- Concluding Remark: End with a sentence or two that encapsulates the overall message or conclusion of your presentation
- Maintain consistency in styling throughout your presentation for a cohesive look.
- Use color or size variations to emphasize the hierarchy of concepts summarized.
Closing Thoughts
Understanding the different types of slides and how to use them can significantly enhance your presentations. Feel free to mix and match slides based on your needs and presentation style. By choosing the right slides, you can create a more engaging presentation that leaves a lasting impression on your audience.
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Frequently Asked Questions
Which are the important slides for any presentation.
The core slides include:
- Title Slide: Captures attention with your presentation title, your name, and affiliation (if applicable).
- Agenda Slide: Briefly outline the key points you’ll cover, setting expectations for your audience.
- Closing Slide: Summarize your main takeaways and leave a lasting impression.
I have a ton of data. Should I use a text-heavy slide or a chart?
Charts win every time! Bullet points and dense text overload audiences. Visualize your data with clear charts (bar graphs, pie charts) to make it easily digestible.
Can I use images and videos in my slides?
Absolutely! High-quality visuals like pictures, infographics, and short videos can boost engagement and illustrate complex concepts. Just ensure they’re relevant and add value.
How can I make my slides more visually appealing?
Maintain a consistent color scheme, use high-resolution images, and avoid clutter. Explore presentation software features like animations and transitions, but use them sparingly to avoid distraction.
How can I find high-quality visual templates for my slides?
There are many resources available! Many presentation software programs like SlidesAI offer built-in image libraries. You can also find free stock photo websites or purchase royalty-free images from online marketplaces. Remember to check licensing requirements before using any visuals.
Are there any slide types I should avoid?
Slides overloaded with text are a major turn-off for audiences. Aim for visuals and concise points. Similarly, avoid excessive animations and transitions, which can be distracting.
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- Published: 04 September 2024
Immunological studies in trans-individuals undergoing gender affirming hormone therapy
- Anna James 1 &
- Petter Brodin 1 , 2 , 3
Nature Reviews Immunology ( 2024 ) Cite this article
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- Therapeutics
- Translational immunology
Personalized medicine for all requires a shift in science and clinical culture that puts more emphasis on the sources of inter-individual variation. Important examples are sex differences in the presentation and severity of diseases, as well as in responses to therapy. Understanding the mechanisms that drive these differences is important in the context of individualized healthcare, and also to better understand the immune sequelae of long-term sex hormone supplementation or inhibition in transgender individuals.
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Forsyth, K. S., Jiwrajka, N., Lovell, C. D., Toothacre, N. E. & Anguera, M. C. The conneXion between sex and immune responses. Nat. Rev. Immunol. 24 , 487–502 (2024).
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Unit for Clinical Pediatrics, Dept. of Women’s and Children’s Health, Karolinska Institutet, Solna, Sweden
Anna James & Petter Brodin
Medical Research Council Laboratory of Medical Sciences (MRC LMS), Imperial College Hammersmith Campus, London, UK
Petter Brodin
Department of Immunology and Inflammation, Imperial College London, London, UK
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James, A., Brodin, P. Immunological studies in trans-individuals undergoing gender affirming hormone therapy. Nat Rev Immunol (2024). https://doi.org/10.1038/s41577-024-01070-0
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IMAGES
VIDEO
COMMENTS
Patient age, gender, clinical presentation, tumour size, TNM staging as per CT scan findings, surgical procedure, pathological TNM staging, histopathological findings, adjuvant therapy, tumour recurrence and patient survival were assessed.
Key elements of each presentation type are described below. Examples of how these would be applied to most situations are provided in italics. The formats are typical of presentations done for internal medicine services and clinics. Note that there is an acceptable range of how oral presentations can be delivered.
Presenting patient cases is a key part of everyday clinical practice. A well delivered presentation has the potential to facilitate patient care and improve efficiency on ward rounds, as well as a means of teaching and assessing clinical competence.1 The purpose of a case presentation is to communicate your diagnostic reasoning to the listener, so that he or she has a clear picture of the ...
A clinical and rhetorical definition with implications for teaching and learning the case-presentation format. Academic Medicine. 74(10):S124-S127. ... Request a consultant's advice on a clinical problem: the presentation will be focused on the clinical question being posed to the consultant. ... Discuss other past medical history that bears ...
The epidemiology, definitions, risk factors, clinical presentation, diagnosis, and outcomes of sepsis are reviewed here. The pathophysiology and treatment of sepsis are discussed separately. (See "Pathophysiology of sepsis" and "Evaluation and management of suspected sepsis and septic shock in adults".) EPIDEMIOLOGY
Clinical presenting is the language that doctors use to communicate with each other every day of their working lives. Effective communication between doctors is crucial, considering the collaborative nature of medicine. As a medical student and later as a doctor you will be expected to present cases to peers and senior colleagues.
Patient Presentation. Medical students learn how to take a patient's history and perform a physical exam, but it is more challenging to reason through your clinical findings and subsequently present to an attending. Your clinical presentation style will change depending on the environment, medical department, and supervising physician.
A clinical presentation is the mode by which a patient presents to a physician and represents the clinical problem a physician is expected to manage. Big picture: The curriculum begins and ends with a focus on the patient, specifically the patient's clinical presentation. Deconstruct and independent learning: Each clinical presentation is ...
Chronic obstructive pulmonary disease (COPD) is estimated to affect 32 million persons in the United States and is the third leading cause of death in this country. Patients typically have symptoms of chronic bronchitis and emphysema, but the classic triad also includes asthma (see the image below).
Presentations of COVID-19 range from asymptomatic/mild symptoms to severe illness and mortality. ... infection is the medical term for what is commonly called long COVID or "long haulers". ... A Non-systematic Review of Clinical Presentation, Potential Effects of Physiological Adaptations in Pregnancy, and Placental Vascular Alterations. Front ...
The most common clinical presentations of hypertensive emergencies are cerebral infarction (24.5%), pulmonary edema ... hypertensive heart disease is a term applied generally to heart diseases—such as LVH, ... Patients Without Other Major Medical Condition. First-line Drugs. Added 2 nd Drug (if needed to reach BP target)
The documentation should state "evolving clinical presentation with changing characteristics" and describe what has been changing and what will be monitored, such as fluctuating pain, swelling, changes in vital signs, etc., to support an "evolving" clinical presentation statement. UNSTABLE and unpredictable characteristics are evident ...
Management of Land and Natural Resources (Social Science) Pollution and Threats to the Environment (Social Science) Social Impact of Environmental Issues (Social Science) AbstractThis chapter provides concise details of the clinical features, immediate management, key investigations, and further management of all of the comm.
The clinical presentation and diagnostic evaluation of undifferentiated shock and the evaluation of patients with specific forms of shock are discussed separately. ... It is not intended to be medical advice or a substitute for the medical advice, diagnosis, or treatment of a health care provider based on the health care provider's examination ...
AbstractThe term supraventricular tachycardia (SVT) refers to all tachycardias originating from supraventricular tissue (i.e. the sinus node, atria, or atr ... 32.10 Dilated cardiomyopathy: clinical diagnosis and medical management Notes. Notes. 32.11 ... 38.14 Congenital atrioventricular block: Clinical presentation, clinical evaluation, and ...
2 meanings: of or relating to a clinic [...].... Click for more definitions.
Presentation (medical) This definition of medical jargon . In medicine, a presentation is the appearance in a patient of illness or disease—or signs or symptoms thereof—before a medical professional. In practice, one usually speaks of a patient as presenting with this or that. Examples include:
The definition of an atypical presentation of illness is: when an older adult presents with a disease state that is missing some of the traditional core features of the illness usually seen in younger patients. Atypical presentations usually include one of 3 features: (a) vague presentation of illness, (b) altered presentation of illness, or (c ...
To begin with, you need to create an outline of the topics you might present at the meeting. Your outline should follow the IMRAC format (introduction, methods, results, and conclusion). This format is chosen because your audience understands it and expects it. If you have already prepared a paper for publication, it can be a rich source of ...
Numerous recommendations for presenting well are available to academic physicians. 1-13 Even though we agree with these guides, little empirical evidence is available in the medical field defining the most important features of a presentation, especially at scientific meetings. 14-17 Shorter presentations at scientific meetings, usually 10 ...
History. Many early breast cancers are asymptomatic, particularly if they were discovered during a breast-screening program. Larger tumors may present as a painless mass. Pain or discomfort is not usually a symptom of breast cancer; only 5% of patients with a malignant mass present with breast pain. Often, the purpose of the history is not ...
Anxiety, agitation or restlessness. Slowed thinking, speaking or body movements. Feelings of worthlessness or guilt, fixating on past failures or self-blame. Trouble thinking, concentrating, making decisions and remembering things. Frequent or recurrent thoughts of death, suicidal thoughts, suicide attempts or suicide.
Importance Advancing precision psychiatry, where treatments are based on an individual's biology rather than solely their clinical presentation, requires attention to several key attributes for any candidate biomarker. These include test-retest reliability, sensitivity to relevant neurophysiology, cost-effectiveness, and scalability. Unfortunately, these issues have not been systematically ...
pre· sent· ing pri-ˈzent-iŋ. : of, relating to, or being a symptom, condition, or sign which is evident or disclosed by a patient on physical examination. may be the presenting sign of a severe systemic disease H. H. Roenigk, Jr.
Our study has several limitations. First, the study was limited to 6 months. This is shorter than previous clinical trials assessing AF ablation, which typically have a follow-up of at least 1 year; however, the study aim was not to elucidate the long-term effect of AF ablation but rather the placebo effect, if any.
The Total Force Fitness program arose within the U.S. Department of Defense Military Health System in response to the need for a more holistic approach—a focus on the whole person instead of separate parts or only symptoms—to the demands of multiple deployments and the strains on the U.S. Armed Forces and their family members.
Detailed results from the Phase III OASIS 3 study evaluating the efficacy and long-term safety of investigational compound elinzanetant will be presented for the first time at this year's Annual Meeting of The Menopause Society (TMS) / First presentation of pooled efficacy analysis from pivotal Phase III studies OASIS 1 and 2 / Elinzanetant is the first dual neurokinin-1 and 3 (NK-1 and 3 ...
Frequently Asked Questions Which are the important slides for any presentation? The core slides include: Title Slide: Captures attention with your presentation title, your name, and affiliation (if applicable). Agenda Slide: Briefly outline the key points you'll cover, setting expectations for your audience. Closing Slide: Summarize your main takeaways and leave a lasting impression.
Immunological research has been slow to consider sex as a biological variable, despite the many reports of sex differences in the prevalence and mortality of autoimmune diseases, viral infections ...