Shared decision making in patients with low risk chest pain: prospective randomized pragmatic trialBMJ 2016; 355 doi: https://doi.org/10.1136/bmj.i6165 (Published 05 December 2016) Cite this as: BMJ 2016;355:i6165
All rapid responses
Abdullah Almanea,1 Abdulaziz Alsaad,1 Rajkumar Rajendram2
1. College of Medicine, King Saud bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia
2. Department of Internal Medicine, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia
In Saudi Arabia (SA), 25% of adults have hypertension, 23.7% have diabetes and 35.5% are either obese or overweight.[1-3] It is therefore unsurprising that the prevalence of coronary artery disease is high (5.5%). Patients presenting with acute coronary syndrome in SA are almost a decade younger than those in developed countries and in 2014, cardiovascular diseases caused 41000 deaths (46% of all-cause mortality) in SA. These horrific statistics mandate early detection of those at high risk; so patients presenting with chest pain in SA are generally managed aggressively.
We therefore read with great interest the study of shared decision making in patients with low risk chest pain reported by Hess et al. Their model improved patient autonomy and increased patients’ understanding of their health. They delivered a personalized service tailored to the ideas, concerns and expectations of the patients; reducing decisional conflict whilst avoiding hospital admissions.
However the effective and safe use of such decision aids hinges upon the accurate risk stratification of patients. The Thrombolysis in Myocardial Infarction (TIMI) and Global Registry of Acute Cardiac Events (GRACE) risk scores, for example, were developed from high risk populations and so are not as useful in lower risk populations in the emergency department. So, to achieve the outcomes reported by Hess et al. in our patients; an appropriate risk stratification tool must first be validated in the general population of SA.
Secondly, it is important to recognize that the majority of Saudi women, and even some men, routinely delegate the responsibility for decisions about their healthcare to a senior male relative. So not only must the accompanying decision aid be translated into Arabic it must also be adapted to reflect the cultural sensitivities of the local population.
The significant morbidity and mortality associated with cardiovascular diseases in SA provokes anxiety in both patients and healthcare professionals. Patient dissatisfaction is most commonly associated with unmet desire for further investigation and poor involvement in decision-making.[8-9] However, hospital admissions is one of the highest contributors to the total cost of treating ischemic heart disease in SA. Shared decision making may be able to elegantly resolve all these issues. However significant work is required before this can be effectively and safely applied to the general population of Saudi Arabia.
1. Al-Nozha MM, Abdullah M, Arafah MR, Khalil MZ, Khan NB, Al-Mazrou YY, Al-Maatouq MA, Al-Marzouki K, Al-Khadra A, Nouh MS, Al-Harthi SS, Al-Shahid MS, Al-Mobeireek A. Hypertension in Saudi Arabia. Saudi Med J. 2007;28:77-84.
2. Al-Nozha MM, Al-Maatouq MA, Al-Mazrou YY, Al-Harthi SS, Arafah MR, Khalil MZ, Khan NB, Al-Khadra A, Al-Marzouki K, Nouh MS, Abdullah M, Attas O, Al-Shahid MS, Al-Mobeireek A. Diabetes mellitus in Saudi Arabia. Saudi Med J. 2004;25:1603-10.
3. Al-Nozha MM, Al-Mazrou YY, Al-Maatouq MA, Arafah MR, Khalil MZ, Khan NB, Al-Marzouki K, Abdullah MA, Al-Khadra AH, Al-Harthi SS, Al-Shahid MS, Al-Mobeireek A, Nouh MS. Obesity in Saudi Arabia. Saudi Med J. 2005;26:824-9.
4. Alhabib KF, Hersi A, Alfaleh H, Alnemer K, Alsaif S, Taraben A, Kashour T, Bakheet A, Qarni AA, Soomro T, Malik A, Ahmed WH, Abuosa AM, Butt MA, Almurayeh MA, Zaidi AA, Hussein GA, Balghith MA, Abu-Ghazala T. Baseline characteristics, management practices, and in-hospital outcomes of patients with acute coronary syndromes: results of the Saudi project for assessment of coronary events (SPACE) registry. J Saudi Heart Assoc. 2011; 23: 233–239.
5. World Health Organisation. Saudi Arabia, Noncommunicable Diseases Country Profiles, 2014. World Health Organisation, 2014, Switzerland. Available at: http://www.who.int/nmh/countries/sau_en.pdf (accessed 12/05/17).
6. Hess EP, Hollander JE, Schaffer JT, Kline JA, Torres CA, Diercks DB, Jones R, Owen KP, Meisel ZF, Demers M, Leblanc A, Shah ND, Inselman J, Herrin J, Castaneda-Guarderas A, Montori VM. Shared decision making in patients with low risk chest pain: prospective randomized pragmatic trial. BMJ 2016;355:i6165.
7. Yan AT1, Yan RT, Huynh T, Casanova A, Raimondo FE, Fitchett DH, Langer A, Goodman SG; Canadian Acute Coronary Syndrome Registry 2 Investigators. Understanding physicians' risk stratification of acute coronary syndromes: insights from the Canadian ACS 2 Registry. Arch Intern Med. 2009;169:372-8.
8. Marple RL, Kroenke K, Lucey CR, Wilder J, Lucas CA. Concerns and expectations in patients presenting with physical complaints: frequency, physician perceptions and actions, and 2-week outcome. Arch Intern Med. 1997;157:1482–1488.
9. Abolfotouh MA, Al-Assiri MH, Alshahrani RT, Almutairi ZM, Hijazi RA, Alaskar AS. Predictors of patient satisfaction in an emergency care centre in central Saudi Arabia: a prospective study. Emerg Med J. 2017;34:27-33.
10. Osman AM, Alsultan MS, Al-Mutairi MA. The burden of ischemic heart disease at a major cardiac center in Central Saudi Arabia. Saudi Med J. 2011;32:1279-84.
Competing interests: No competing interests
I read with interest the article. An attempt to solve this common dilemma is praiseworthy. However, the low risk chest pain and the chest pain in a low-risk patient is qute different. To clarify, a true vignette: a 32- year old Bangaladeshi male manual labour patient presents to emergency department with burning in epigastrium for last 36 hours. He has no identifiable major coronary risk factor. He came to emergency as he finds it difficulty to work effectively, even though he can work slowly . His ECG and hs- troponin I (two sets 3-hour apart) are non-contributory. As per the criteria used in the study he has low-risk symptom. He was discharged from emergency, only to be readmitted in another hospital, following a out-of-hospital (resucitated) cardiac arrest at workplace.
While evaluating chest pain, it should be mentioned pain/discomfort from jaw- to- umbilicus, located both anteriorly, posteriorly and on either side (not only anterior chest pain, as commonly perceive) and not only characteristics of pain (typical/atypical/non-anginal) along with ECG and cardaic enzyme are taken into account, but overll assessment of the patient background, race, eductional status, accessibility to the nearest heathcare services, and coverage with medical insurance schemes are to be figured into decision making/conveying to the patient to impart comprehensive heathcare.
We have encountered enough blunders based on conventional decision making in our patients: a lesson worth memorizing.
Competing interests: No competing interests
We commend Hess et al for their well-designed and clinically useful pragmatic shared decision making study (1). This is sure to serve as an example for shared decision making research addressing other clinical scenarios, both in the emergency department and beyond.
Shared decision making is best suited for the fork in the road, a divergence of care where neither course is clearly superior (2). Such a decision, though equivocal from the clinician’s perspective, is “preference-sensitive” when seen in a patient-centered light. The Centers for Medicare and Medicaid Services applies shared decision making to conditions “for which the clinical evidence does not clearly support one treatment option, and the appropriate course of treatment depends on the values or preferences of the beneficiary regarding the benefits, harms, and scientific evidence for each treatment option” (3). This appears to be true at the moment regarding the site-of-care decision for many low-risk chest pain patients: should they go home to follow-up with their primary care provider or should they be admitted for short-term observation and provocative testing? Let’s educate our patients and help them decide.
But the field is rapidly changing: what is equivocal today may not be so in the coming years. The advent of highly sensitive troponin assays, with or without the use of refined risk stratification pathways, will help us identify emergency department patients with short-term risks of acute coronary syndrome sufficiently low to obviate the need for observation and advanced cardiac testing prior to home discharge (4-6). As evidence continues to accumulate that this practice is safe, clinicians will feel empowered to confidently shift the site of care in an outpatient direction for a growing number of low-risk chest pain patients. This shift in emergency department disposition is a familiar transition, and when done safely can be associated with increased patient convenience and satisfaction as well as a more responsible stewardship of healthcare resources. We have learned to do this with low-risk pneumonia (7) and are learning to do it with low-risk pulmonary embolism (8).
Even in this projected future of increasing outpatient care for low-risk chest pain, the best emergency department disposition will at times remain an open question. Here the patient’s preference elicited during shared decision making can be called upon to guide management, as Hess et al have shown (1). But absent the equipoise of “preference-sensitive” conditions, when the clinician believes that home management is the optimal disposition, we still need to do better at educating our patients about their risks and explaining to them the rationale of the recommendations we provide. The well-conceived, field-tested patient-centered decision aid that Hess and colleagues used in this study is readily adaptable for just this task. Whether we’re soliciting a patient’s tie-breaking opinion on site of care (shared decision making) or we’re informing them why we think a certain disposition is most appropriate (patient education), a clear, accessible pictographic decision aid can help us more clearly communicate our thoughts and leave the patient with a fuller understanding of their situation (1).
The next generation of electronic shared decision making tools may take this even further by incorporating principles from learning healthcare systems. These new tools that we envision would update risk calculators based on the most recent evidence and also tailor the risk profiling to the very population and heathcare setting where the patient is being treated. We also foresee a day when patient-specific preferences – their risk-tolerance, cultural affiliations and even prior shared decision making choices – are integrated into the electronic shared decision making interface that frames the patient-physician discussion. As we have learned from this study, with a good decision aid in hand, that extra patient-centered discussion takes only an extra minute. And we can’t imagine a minute better spent.
1. Hess EP, Hollander JE, Schaffer JT, et al. Shared decision making in patients with low risk chest pain: prospective randomized pragmatic trial. BMJ 2016;355:i6165. DOI: 10.1136/bmj.i6165 [PMCID: PMC5152707]
2. Melnick ER, Probst MA, Schoenfeld E, et al. Development and testing of shared decision making interventions for use in emergency care: a research agenda. Acad Emerg Med 2016;23:1346-1353. DOI: 10.1111/acem.13045 [PMID: 27457137]
3. Centers for Medicare and Medicaid Services. Beneficiary Engagement Initiative: Shared Decision Making (SDM) Model. https://innovation.cms.gov/initiatives/beneficiary-engagement-sdm/ Accessed December 16, 2016.
4. Shah AS, Anand A, Sandoval Y, et al. High-sensitivity cardiac troponin I at presentation in patients with suspected acute coronary syndrome: a cohort study. Lancet 2015;386(10012):2481-8. DOI: 10.1016/S0140-6736(15)00391-8 [PMCID: PMC4765710]
5. Than MP, Pickering JW, Aldous SJ, et al. Effectiveness of EDACS versus ADAPT Accelerated Diagnostic Pathways for chest pain: A pragmatic randomized controlled trial embedded within practice. Ann Emerg Med 2016;68:93-102.e1. DOI: 10.1016/j.annemergmed.2016.01.001 [PMID: 26947800]
6. Mahler SA, Riley RF, Hiestand BC, et al. The HEART Pathway randomized trial: identifying emergency department patients with acute chest pain for early discharge. Circ Cardiovasc Qual Outcomes 2015;8:195-203. DOI: 10.1161/CIRCOUTCOMES.114.001384 [PMCID: PMC4413911]
7. Chalmers JD, Akram AR, Hill AT. Increasing outpatient treatment of mild community-acquired pneumonia: systematic review and meta-analysis. Eur Respir J 2011;37:858-64. DOI: 10.1183/09031936.00065610 [PMID: 20729221]
8. Vinson DR, Zehtabchi S, Yealy DM. Can selected patients with newly diagnosed pulmonary embolism be safely treated without hospitalization? A systematic review. Ann Emerg Med 2012;60:651-662.e4. DOI: 10.1016/j.annemergmed.2012.05.041 [PMID: 22944455]
Competing interests: No competing interests
Re: Shared decision making in patients with low risk chest pain: prospective randomized pragmatic trial
This research is certainly welcome; it brings to mind the critique of Michel Foucault. So often knowledge is kept within our hands as doctors, leaving patients bereft of both knowledge and the power of what should happen next, a rather vulnerable position to be in, only augmented by what can be a terrifying experience lying prone in an emergency department, petrified that the pain might be a heart attack. This study reclaims both knowledge and power for the patient.
The main caveat is the study's applicability for socialised forms of healthcare. Are paying patients more likely to avoid hospital admission? Would a patient receiving care in Germany, Switzerland, UK et al, be more likely to stay in hospital-precisely because the cost is not borne directly?
Additionally, as per Foucault, Power's "success is proportional to its ability to hide its own mechanisms." Perhaps these decision aids are just another means of imposing our will, in the hope of avoiding litigation?
Competing interests: No competing interests
A short discussion of ‘risk informed shared decision-making in the emergency setting’ in the context of English Law
I recently read both ‘Realistic Medicine’, written by the Chief Medical Officer of Scotland (ref 1), and ‘Consent: Supported Decision-Making, a guide to good practice’ from the Royal College of Surgeons of England (ref 2). Both mention the Montgomery court ruling (ref 3), but interestingly the RCS guidance does not mention ‘shared decision-making’ at all, although it mentions ‘supported decision-making’ many times – whereas Realistic Medicine never uses the term supported decision-making but has many mentions of shared decision-making.
This paper by Hess et al uses ‘interesting phrasing’, such as:
‘We sought to assist patients and clinicians in making a risk informed shared decision in the emergency setting in which patients typically do not have the opportunity to learn about their condition prior to the visit and clinicians often make decisions unilaterally to facilitate patient safety and rapid treatment of life threatening conditions.’
The study by Hess et al took place in the US, which I understood had arrived at ‘Informed Consent’ before England and Scotland reached the same [legal] situation: and it is the Royal College of Surgeons, in its recent guidance about consent, which correctly explains the objective of obtaining Informed Consent from a patient, and the process of Supported Decision-Making in which the doctor provides the patient with the information necessary to consider the decision, and thus equipped the patient then makes the decision.
This is unequivocally not ‘shared decision-making’: Hess et al tell readers that ‘Compared with the usual care arm, patients in the decision aid arm had greater knowledge of their risk for acute coronary syndrome and options for care’ which equates to ‘the decision aid led to the patients being better-informed’. There are obvious complications, with the legal objective of supported decision-making as it applies during an unforeseen ‘emergency’ situation, which include:
* time constraints on how much information can be imparted to the patient
* time constraints on the process of checking if the patient understood the information
and also more complex issues, such as the patient not wanting to make the decision, and asking the doctor to decide. Or the patient expressing an objective - ‘just get on with it, and keep me alive !’ - which is ‘legally interesting’ (it amounts to ‘non-informed consent’: I decline to analyse non-informed consent, here). But, either the necessary support for the patient to express a genuinely-informed decision has been achieved, or else for some reason ‘Informed Consent’ has not been achieved. The situation is even more complex if there is a legitimate reason to doubt the patient's mental capacity, but the word-limit on rapid responses precludes discussion of that situation: I am assuming the patient is mentally capable for the purposes of this piece.
If Informed Consent has not been achieved, for whatever reason, then either the patient has expressed an ‘inadequately-informed’ decision [compared to adequately-informed consent] or else the doctor has made the decision – neither is ‘shared’.
Hess et al also tell readers:
‘The decision aid was found to be acceptable to both patients and physicians, and its use, which took an average of one additional minute of clinician time, decreased the rate of admission to an observation unit for advanced cardiac testing and cardiac stress testing within 30 days of the emergency department visit. No major adverse cardiovascular events (MACEs) were related to the intervention.’
Which viewed in terms of outcomes, looks fine. Although informed consent does not look at outcomes, in legal terms – the law examines whether the patient was informed, and not the eventual outcome of the patient’s decision (things such as ‘targets’ and ‘quality markers’ almost certainly do look at ‘outcomes’ - I can only describe this as doctors being squeezed between a legal rock and a ‘managerial’ hard place). Hess et al also tell readers:
‘While use of shared decision making might decrease clinician’s liability risk by improving the patient-clinician relationship, enhancing communication (which is often at the root of lawsuits brought against clinicians after an adverse outcome  ), and decreasing the frequency of invasive procedures,  shared decision making might increase liability risk if the care agreed on by the patient and clinician is sensible but perhaps at odds with what other clinicians would have selected without patient input, as the latter is often used to determine “standard of care.”’
This phrase ‘standard of care’ presumably applies to things aside from consent: it must describe concepts such as ‘the best treatment(s) to offer’, and in Montgomery Lady Hale was very clear about this, in section 115:
‘A patient is entitled to take into account her own values, her own assessment of the comparative merits of giving birth in the “natural” and traditional way and of giving birth by caesarean section, whatever medical opinion may say, alongside the medical evaluation of the risks to herself and her baby. She may place great value on giving birth in the natural way and be prepared to take the risks to herself and her baby which this entails. The medical profession must respect her choice, unless she lacks the legal capacity to decide‘
And, in section 116:
‘Gone are the days when it was thought that, on becoming pregnant, a woman lost, not only her capacity, but also her right to act as a genuinely autonomous human being.’
The key word is ‘autonomous’ - it is deeply perverse to blame a doctor for a bad decision which an autonomous patient had made and expressed, when senior judges are making it very clear that our law is now Informed Consent.
Competing interests: No competing interests