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CORRESPONDENCE

Bad assumptions on primary care diagnostic errors. Response to: ‘Advancing the science of measurement of diagnostic errors in healthcare: the Safer Dx framework’ by Singh and Sittig There are so many bad assumptions in this article.1 I will just expand on two. First, there is no recognition in their model of probabilities. Everything is constructed as a black or white phenomenon, which is a world away from the day to day realities of patient care. This is another prime example of the inappropriate application of industrial thinking to the human endeavour of patient care. (This was written by two engineers apparently, and not surprisingly). How will their machines handle a patient who went to work, drove herself to the clinic, filled out all the papers correctly, and the proceeds to tell me the severity of the pain she has had for 2 years without a diagnosis is an 11 on a 10-point scale? Second, this kind of thinking undermines primary care. In fact, the whole concept of delayed diagnosis in primary care needs to be severely curtailed, or my preference would be to abandon it. When I see a patient who has had a cough for 2 weeks, of course I realise that it could be the earliest manifestation of a whole host of rare conditions: Wegener’s, an inhaled foreign body, lung cancer, histoplasmosis, occupational lung disease and other conditions. However, I do not order CT scans, rheumatologic panels and blood titres for rare infections with every patient I see with a cough. This means that the few times over the course of my career that I care for a patient with the first manifestations of a rare disease, I should not be vilified for making a delayed diagnosis. I will figure out the rare disease a few weeks or months later

when the cough persists beyond that of a common condition, or when a true red flag sign or symptom appears. Every element of the history, review of systems, family history, social history, examination and other factual nuggets speaks to the probabilities of the rare disease (or unusual presentation of a more common disease), but the chance of complete reassurance of a benign condition or harbinger of a severe disease at the initial presentation never comes close to certainty. Instead of vilifying me, the regulators and other pundits should congratulate me for keeping from harm the thousands of patients with coughs I did not expose to unnecessary fear, expense and radiation. Family physicians and general practitioners deliver better care at a lower cost than all other physicians precisely because we are more comfortable with uncertainty and are comfortable applying overall probabilities to individual patient care situations. Except in the most straightforward cases of blatant negligence, the language of delayed or missed diagnoses has no place in our world. Richard A Young

Correspondence to Dr Richard A Young, John Peter Smith Hospital Family Medicine Residency Program, 1500 S. Main, Fort Worth, Texas 76104, USA; [email protected]

Competing interests None. Provenance and peer review Not commissioned; internally peer reviewed.

To cite Young RA. BMJ Qual Saf 2015;24:345. Accepted 19 February 2015 Published Online First 6 March 2015

▸ http://dx.doi.org/10.1136/bmjqs-2015-004140 BMJ Qual Saf 2015;24:345. doi:10.1136/bmjqs-2015-004091

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REFERENCE 1 Singh H, Sittig DF. Advancing the science of measurement of diagnostic errors in healthcare: the Safer Dx framework. BMJ Qual Saf 2015;24:103–10.

Setting the record straight on measuring diagnostic errors. Reply to: ’Bad assumptions on primary care diagnostic errors’ by Dr Richard Young Upon reading Dr Young’s letter,1 we felt we should have prefaced our article by quoting Box and Draper who wrote in their classic 1987 book,2 ‘all models are wrong, but some are useful’. Our goal in developing a new model for safer diagnosis in healthcare was to illustrate the myriad, complex, sociotechnical issues and their interactions within a complex adaptive healthcare system that must be considered when attempting to define and measure errors in the diagnostic process.3 While the comments by Dr Young provide one clinician’s view of the complexity and breadth of diagnostic error, we welcome an opportunity to respond to clarify the premise of the Safer Dx framework. Dr Young is concerned that we presented the problem of diagnostic error as black and white rather than considering day-to-day realities of patient care that includes vast uncertainties in data collection, interpretation and synthesis. He further asserts that the concept of delayed diagnosis in primary care needs to be severely curtailed and that except for straightforward cases of blatant negligence we should not even use the language of delayed or missed diagnoses. Lastly, he writes that physicians might be vilified for missed or delayed diagnosis even though they made appropriate and informed decisions including watchful waiting when the

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Correspondence diagnosis was not yet clear. In our response below, we attempt to lay many of these concerns to rest and provide further information on diagnostic error reduction research. We believe the concepts that we clarify herein will reassure hardworking primary care clinicians on the frontlines that the major goal of our framework is to promote the understanding and reduction of preventable diagnostic harm to our patients and not assign blame. Moreover, the rationale for the framework and our response applies to all clinicians, not just those in primary care. First, we would like to clarify that the goal of the paper was to establish a foundation for using a systems-based approach to advance the science of measurement of diagnostic error rather than to debate the challenges of defining diagnostic error in individual patients, which we agree are plentiful, as seen in our research.4–6 Frameworks allow researchers and other stakeholders to have a highlevel, conceptual understanding of the problem they are trying to solve as well as help them consider the many moving parts and their relationships that influence the problem. To specifically respond to Dr Young’s concern, we explicitly mentioned the ‘difficult conceptualisation of the diagnostic process’ as a problem in the introduction of the paper as well as acknowledged that ‘diagnosis evolves over time and is not limited to events during a single provider visit’. We also stated the need to address the problem of diagnostic error through better measurement tools and rigorous definitions. This conceptual approach will lead to a more robust understanding of what the diagnostic process entails and what breakdowns exist, especially beyond the patient-provider level, such as at the system level. Over the last 15 years since the ‘To Err Is Human’ Institute of Medicine report,7 there has been little progress in reducing diagnostic errors,

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which consistently show up in many studies as a prominent reason for preventable harm to patients.8–12 One of the many gaps contributing to this lack of progress is precisely the poor understanding of the entire diagnostic measurement process that we are trying to improve with the Safer Dx framework. The framework helps ensure that improvement efforts are consistent within the larger systems-based approach in improving patient safety.13 As we mention in our paper, ‘high quality diagnostic performance requires both a well-functioning healthcare system along with high-performing individual providers and care teams within that system’. By borrowing concepts from non-healthcare-related disciplines (such as human factors and medical informatics) to improve systems, we are ensuring that the many moving parts of our framework, including tools and technologies, can best fit within and support the physician’s work environment in order to improve patient safety.14–17 In fact, one of the paper’s authors (DFS) is a clinical informatician who has worked for >25 years to improve patient care through the use of better information systems and technology. Second, our paper uses a ‘realworld’ definition of diagnostic error18 and acknowledges some of the uncertainties and evolution in the diagnostic process that Dr Young writes about. This definition has been developed through several large studies over the past decade4–6 by one of the authors (HS), who is a practising internist with primary care experience in both academic and rural settings. All of these studies have illustrated the many ‘grey zones’ related to diagnostic error. Although a briefer version of the definition of diagnostic error is mentioned in the paper, the following passage from the original citation we referenced in our paper18 might help clarify how we contextualise the concept of errors as missed opportunities to promote learning and improvement rather than to assign blame:

Although it’s tempting to assign responsibility for a diagnostic error to a single clinician, research suggests that the interplay of both system and cognitive contributory factors is almost universal. Thus, in our work within our multidisciplinary research group, we have shifted toward rebranding diagnostic errors as “missed opportunities”. While our research team continues to refine definitions and measurement, we have found the following three criteria useful in defining diagnostic errors: 1. Case Analysis Reveals Evidence of a Missed Opportunity to Make a Correct or Timely Diagnosis. The concept of a missed opportunity implies that something different could have been done to make the correct diagnosis earlier. The missed opportunity may result from cognitive and/or system factors or may be attributable to more blatant factors, such as lapses in accountability or clear evidence of liability or negligence. 2. Missed Opportunity Is Framed Within the Context of an “Evolving” Diagnostic Process. The determination of error depends on the temporal or sequential context of events. Evidence of omission (failure to do the right thing) or commission (doing something wrong) exists at the particular point in time at which the “error” occurred. 3. The Opportunity Could Be Missed by the Provider, Care Team, System, and/or Patient. A preventable error or delay in diagnosis may occur due to factors outside the clinician’s immediate control or when a clinician’s performance is not contributory. This criterion suggests a system-centric versus physician-centric approach to diagnostic error. Reframing diagnostic errors as missed opportunities in diagnosis could help shift attention and resources from attributing blame to learning from these scenarios.

Thus, case examples that would qualify as errors would include failure to evaluate a patient further

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Correspondence despite the presence of red flag symptoms for cord compression,19 failure to notify a patient and follow-up on their abnormal chest X-ray report suggestive of cancer leading to delay in cancer diagnosis,20 and delays in diagnosis due to breakdowns in the referral process.21 22 Instances of appropriate and informed decisions including watchful waiting when the diagnosis is not clear will not be categorised as diagnostic errors with this definition. Furthermore, one of the authors (HS) has recently outlined the many challenges of defining diagnostic error in a separate paper that discusses concepts such as diagnosis is not always black and white, watchful waiting and overzealous diagnostic pursuits.23 At the risk of duplicating our previous publication materials and due to journal space constraints, we did not offer this level of detail while describing the Safer Dx framework but are pleased to use this opportunity to do so. In summary, this approach acknowledges the complexity of identifying diagnostic errors, addresses the concern that we need to contextualise diagnostic errors within real-world clinical settings and highlights our responsibility to continually improve. Lastly, we disagree that the paper makes attempts to blame and vilify primary care physicians. We would hope that concepts we mention such as feedback and learning from missed opportunities, which are important concepts in patient safety, are not misconstrued as blame or vilification. In fact, in a recent opinion editorial in a national newspaper,24 HS further called for the need to address system issues such as time pressures, administrative burden, lack of support tools and slow innovations with electronic health records in order to improve diagnosis through better patient– physician interactions. We recognise the value of primary care and the difficulties that come with its practice and hope that advancing the science of measuring diagnostic errors will bring more attention and

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resources to help reduce preventable harm to our patients. Hardeep Singh,1 Dean F Sittig2 1

Houston Veterans Affairs Center for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey Veterans Affairs Medical Center and the Section of Health Services Research, Department of Medicine, Baylor College of Medicine, Houston, Texas, USA 2 University of Texas School of Biomedical Informatics and the UT-Memorial Hermann Center for Healthcare Quality & Safety, Houston, Texas, USA Correspondence to Dr Hardeep Singh, VA Medical Center (152), 2002 Holcombe Blvd, Houston, TX 77030, USA; [email protected]

Twitter Follow Dean Sittig at @DeanSittig and Hardeep Singh at @HardeepSinghMD Funding HS was supported by the VA Health Services Research and Development Service (CRE 12-033; Presidential Early Career Award for Scientists and Engineers USA 14-274), the VA National Center for Patient Safety and the Agency for Health Care Research and Quality (R01HS022087). This work was supported in part by the Houston VA HSR&D Center for Innovations in Quality, Effectiveness and Safety (CIN 13-413). Disclaimer The views expressed in this article are those of the authors and do not necessarily represent the views of the Department of Veterans Affairs or the University of Texas. Competing interests None. Provenance and peer review Not commissioned; internally peer reviewed.

To cite Singh Hardeep, Sittig DF. BMJ Qual Saf 2015;24:345–348. Accepted 3 March 2015 Published Online First 17 March 2015

▸ http://dx.doi.org/10.1136/bmjqs-2015-004091 BMJ Qual Saf 2015;24:345–348. doi:10.1136/bmjqs-2015-004140

REFERENCES 1 Young RA. Bad assumptions on primary care diagnostic errors. Response to: ‘Advancing the science of measurement of diagnostic errors in healthcare: the Safer Dx framework’ by Singh and Sittig. BMJ Qual Saf 2015;24:345. 2 Box GEP, Draper NR. Empirical model-building and response surfaces. Hoboken: Wiley, 1987.

3 Singh H, Sittig DF. Advancing the science of measurement of diagnostic errors in healthcare: the Safer Dx framework. BMJ Qual Saf 2015;24:103–10. 4 Singh H, Thomas EJ, Khan MM, et al. Identifying diagnostic errors in primary care using an electronic screening algorithm. Arch Intern Med 2007;167:302–8. 5 Singh H, Giardina TD, Meyer AN, et al. Types and origins of diagnostic errors in primary care settings. JAMA Intern Med 2013;173:418–25. 6 Singh H, Giardina TD, Forjuoh SN, et al. Electronic health record-based surveillance of diagnostic errors in primary care. BMJ Qual Saf 2012;21:93–100. 7 Institute of Medicine. To Err is Human: building a safer health system. Kohn LT, Corrigan JM, Donaldson MS, eds. Washington DC: National Academies Press, 1999. 8 Graber ML, Franklin N, Gordon R. Diagnostic error in internal medicine. Arch Intern Med 2005;165:1493–9. 9 Schiff GD, Hasan O, Kim S, et al. Diagnostic error in medicine: analysis of 583 Physician-reported errors. Arch Intern Med 2009;169:1881–7. 10 Zwaan L, Thijs A, Wagner C, et al. Design of a study on suboptimal cognitive acts in the diagnostic process, the effect on patient outcomes and the influence of workload, fatigue and experience of physician. BMC Health Serv Res 2009;9:65. 11 Singh H, Meyer AN, Thomas EJ. The frequency of diagnostic errors in outpatient care: estimations from three large observational studies involving US adult populations. BMJ Qual Saf 2014;23:727–31. 12 Schiff GD. Diagnosis and diagnostic errors: time for a new paradigm. BMJ Qual Saf 2014;23:1–3. 13 Wachter RM. Why diagnostic errors don’t get any respect–and what can be done about them. Health Aff (Millwood) 2010;29:1605–10. 14 Henriksen K, Brady J. The pursuit of better diagnostic performance: a human factors perspective. BMJ Qual Saf 2013;22(Suppl 2):ii1–5. 15 El-Kareh R, Hasan O, Schiff GD. Use of health information technology to reduce diagnostic errors. BMJ Qual Saf 2013;22(Suppl 2):ii40–51. 16 Smith MW, Murphy DR, Laxmisan A, et al. Developing software to “Track

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Correspondence and Catch” missed follow-up of abnormal test results in a complex sociotechnical environment. Appl Clin Inform 2013;4:359–75. 17 Sittig DF, Krall MA, Dykstra RH, et al. A survey of factors affecting clinician acceptance of clinical decision support. BMC Med Inform Decis Mak 2006;6:6. 18 Singh H. Editorial: helping health care organizations to define diagnostic errors as missed opportunities in diagnosis. Jt Comm J Qual Patient Saf 2014;40:99–101. 19 Singh H, Petersen LA, Thomas EJ. Understanding diagnostic errors in

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medicine: a lesson from aviation. Qual Saf Health Care 2006;15:159–64. 20 Singh H, Thomas EJ, Mani S, et al. Timely follow-up of abnormal diagnostic imaging test results in an outpatient setting: are electronic medical records achieving their potential? Arch Intern Med 2009;169:1578–86. 21 Singh H, Esquivel A, Sittig DF, et al. Follow-up Actions on Electronic Referral Communication in a Multispecialty Outpatient Setting. J Gen Intern Med 2011;26:64–9. 22 Gandhi TK, Kachalia A, Thomas EJ, et al. Missed and delayed diagnoses in

the ambulatory setting: a study of closed malpractice claims. Ann Intern Med 2006;145:488–96. 23 Zwaan L, Singh H. The challenges in defining and measuring diagnostic error. Diagnosis 2015;2. doi:10.1515/ dx-2014-0069 24 Singh H. The Battle Against Misdiagnosis. American doctors make the wrong call more than 12 million times a year. The Wall Street Journal 7 August 2014; Sect. Opinion.

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Setting the record straight on measuring diagnostic errors. Reply to: 'Bad assumptions on primary care diagnostic errors' by Dr Richard Young Hardeep Singh and Dean F Sittig BMJ Qual Saf 2015 24: 345-348 originally published online March 17, 2015

doi: 10.1136/bmjqs-2015-004140 Updated information and services can be found at: http://qualitysafety.bmj.com/content/24/5/345.2

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Setting the record straight on measuring diagnostic errors. Reply to: 'Bad assumptions on primary care diagnostic errors' by Dr Richard Young.

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