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Making Health Care Safer II: An Updated Critical Analysis of the Evidence for Patient Safety Practices. Rockville (MD): Agency for Healthcare Research and Quality (US); 2013 Mar. (Evidence Reports/Technology Assessments, No. 211.)

Chapter 35Patient Safety Practices Targeted at Diagnostic Errors (NEW)

Kathryn M McDonald, MM, Despina Contopoulos-Ioannidis, MD, Julia Lonhart, BS, BA, Brian Matesic, BS, Eric Schmidt, BA, Noelle Pineda, BA, and John PA Ioannidis, MD.

How Important Is the Problem?

The family of patient safety targets that includes diagnostic errors, diagnostic delays, and other diagnostic misadventures is not fully defined with clear boundaries. However, one operational definition adapted from the Australian Patient Safety Foundation by Mark Graber and colleagues is that “diagnosis is unintentionally delayed (sufficient information was available earlier), wrong (another diagnosis was made before the correct one), or missed (no diagnosis ever made), as judged from the eventual appreciation of more definitive information.”1 Alternatively and similarly, Gordon Schiff and colleagues have defined diagnostic errors as “any mistake or failure in the diagnostic process leading to a misdiagnosis, a missed diagnosis, or a delayed diagnosis.”2

Depending on the definition and data source, the exact scope of the problem varies, although its magnitude is consistently impressive. A systematic review of 53 different series of autopsies reported a median error rate of 23.5 percent (range, 4.1% to 49.8%) for major errors (clinically missed diagnoses involving a principal underlying disease or primary cause of death) and 9.0 percent (range, 0% to 20.7%)1 for class I errors (the most serious subset of major errors being those likely to have affected patient outcomes).3 These data translate to approximately 35,000 patients who might have survived to discharge from United States hospitals annually had misdiagnosis not happened.(3) A Harris poll found that three in five Americans (63%) are very or extremely concerned that a diagnostic error can take place.4

Numerous disease-specific studies show that 2 percent to 61 percent of patients experienced missed or delayed diagnoses.5 Examining potential causes of delay in diagnosis for colorectal cancer (CRC), 161 of 513 patients (31.4%) with newly diagnosed CRC had at least one previously missed opportunity for their physician to initiate diagnostic workup. These patients averaged 4.2 missed imaging initiation opportunities despite a mean of 5.3 clinical indications for diagnostic workup for CRC.6 In a study of 587 patients diagnosed with lung cancer, 37.8 percent experienced missed clinical opportunities due to failure in recognizing predefined clinical indications for follow-up or failure to complete requested follow-ups. Patients with missed opportunities experienced a significantly longer median time to diagnosis than patients without missed opportunities (132 vs. 19 days, respectively; p < .001). Patient non-adherence to physician recommendations was present in 44 percent of patients with missed opportunities.7 In a survey administered to academic, community, and trainee pediatricians, 54 percent reported making a diagnostic error at least once per month and 45 percent noted making diagnostic errors that harmed patients at least once per year. Survey respondents reported that lack of pertinent historical or clinical information and team processes such as care coordination were contributors to errors.8 Furthermore, research on variation in patient outcomes related to diagnosis timing suggests room for improvement for some high stakes conditions. For example, early identification of sepsis (along with protocols for treatment pathways) has been associated with decreased mortality in surgical intensive care.9 Improving diagnostic speed, accuracy and triage to treatment of such high risk, rapidly developing conditions is another important frontier for those seeking to improve consequential diagnostic delays.

Problems in care related to diagnosis are particularly prevalent among precipitating causes for lawsuits, with studies reporting 25 percent to 59 percent of malpractice claims attributable to diagnostic errors.5,10,11 A recent study of 91,082 diagnosis-related malpractice claims from 1986 to 2005 estimated payments summing to 34.5 billion dollars (inflation-adjusted to 2010 dollars), well over one billion dollars per year. The mean per-claim payout was $378,858 (interquartile range: $72,250 to $472,000).12 Diagnosis-related claims made up 29.1 percent of total claims and accounted for the highest proportion of total payments (35.6%). In terms of severity, lethal injuries accounted for 40 percent of total payments. Another study of 10,739 malpractice claims from the 2005-2009 National Practitioner Data Bank found that diagnosis-related reasons accounted for 45.9 percent of paid claims from outpatient settings (95% confidence interval [CI], 44.4 to 47.4), the most frequently cited reason from that setting. Diagnostic reasons were the second-most frequently cited for paid claims in the inpatient setting (21.1%; 95% CI, 20.0 to 22.3) and when both settings were involved (26.7%; 95% CI, 23.9 to 29.5).13

Some have asserted that diagnostic errors are more likely to be preventable and more likely to result in patient harms than other types of errors (e.g., treatment-related errors, such as wrong-site surgery or incorrect medication dose), making the problem particularly important as well as useful to address.14 Given this potential, the purpose of this review is to assess the multitude of interventions to prevent diagnostic errors and better understand their effectiveness.

What Is the Patient Safety Practice?

Many types of patient safety practices (PSPs) have been devised to address diagnostic errors, and a number haven even been tailored to specific types of diagnostic error, root causes for the error, technologies available, and other factors. Studies of the epidemiology and etiology of diagnostic errors offer the foundation for an even richer and more robust set of potential PSPs in this area. In an analysis of physician-reported errors, Schiff and colleagues found that the most common missed or delayed diagnoses that physicians recalled were pulmonary embolism, drug reactions or overdose, various cancers, acute coronary syndrome, and stroke.2 Incidence rates could not be calculated from the convenience sample: The study focused on understanding the potential root causes of the errors. They determined that errors occurred throughout the diagnostic process and classified the reported cases using the “Diagnostic Error Evaluation and Research (DEER)” project tool. From analysis of the subgroup of major diagnostic errors, over 43 percent were related to clinician assessment (including failure/delay in considering the diagnosis, placing too much weight on competing/coexisting diagnosis) and 42 percent to laboratory and radiology testing (including failure to order needed tests, technical errors in processing specimens/tests, erroneous reading of a test). Some PSPs are designed to target these failure areas—for example, the design and application of algorithms, checklists, and related tools to help identify and weight potential diagnoses.

Viewing diagnostic errors from specific departments or specialties is another approach to understanding contributing factors and designing interventions to mitigate these in specific settings. As an example, Crosby developed a human- and system-oriented framework based on a decade of reviewing emergency department (ED) cases from an urban, public, teaching hospital.15 This framework examined ten areas, each one tied to points of leverage for development and testing of PSPs, and together demonstrating the broad scope of possible interventions to reduce diagnostic errors:

  • Patient factors: systems may be designed around areas that are more prone to risk (e.g., improved staffing with translators).
  • Human/clinician factors: interventions may aim at errors of planning separately from errors of execution, and may also be designed to address cognitive error, skill-set error, task-based error, and/or personal impairment.
  • Outside care systems, ED access, and triage: consideration of these three framework areas aims to understand patterns of failure and errors that affect patients before their arrival in the ED or initiation of care.
  • Teamwork: interventions in this area focus on communication, coordination, conflict resolution, personnel assignment practices (e.g., considerations of capability, workload), and training.
  • Local ED environment, hospital environment, hospital administration and third parties, and community level: systems and resources at each of these four additional levels of the framework have potential for effective interventions to reduce diagnostic errors within the ED and after the patient leaves.

Within the above framework, human and clinician factors have received significant attention from researchers interested in diagnosis. Cognitive factors may affect diagnostic accuracy through rote over-learned actions or through purposive reasoning and decisionmaking processes. The cluster of automatic or quasi-automatic decisionmaking processes may be classified as heuristics, or rule-based decisionmaking processes. Heuristics aid in making decisions quickly and are important for keeping cognitive capacity high for other, more demanding, cognitive tasks. However, the very thing that makes heuristics helpful, decisions based on logical assumptions gained from experience, can also lead to systematic bias and incorrect decisionmaking when assumptions are wrong.16 Other cognitive processes affecting diagnosis involve working memory in conjunction with learned knowledge, or more plainly, information that is purposefully stored, recalled and used for completing a current goal. An example of these cognitive processes can be seen in physicians listening to their patients describe symptoms. The physician cognitively stores symptomatic information in the short term until she or he can classify the symptoms into a more general descriptive category of a diagnosis. This process is also subject to error when attention is pulled away from the task at hand or cognitive capacity is altered for others reasons (e.g., lack of sleep). The process of metacognition involves continued focusing and re-focusing attention on these cognitive processes so as to reflect on one's own potential for biases, incorrect assumptions, and reduced cognitive capacity.17 Ultimately, both human factors and the systems within which they operate have long been recognized as unique contributors to human error.18

PSPs relevant to diagnostic error are also being actively developed by those bringing more attention to this important patient safety target, and drawing on previous work in the research domains of medical problem solving, decision analytic/normative decisionmaking, and clinical diagnostic decision support.19 As health information technologies become more pervasive, electronically-supported workflow and system redesign might target preventing or mitigating diagnostic errors. PSPs in this area would be akin to computerized physician order entry with clinical decision support, though more aptly named something like computerized diagnosis management.

Why Should This Patient Safety Practice Work?

Many types of interventions, spanning a range of specialties and settings, are potentially applicable to reducing diagnostic errors. Thus, it is impossible to answer the question of why these interventions should work with one general statement. In addition to some of the frameworks described above as the bases for logic models, recent commentaries and focus group reports offer examples of why specific approaches could work (e.g., electronic clinical documentation, checklists, interventions to decrease the frequency of missed test results).20-22 For electronic documentation, for example, researchers have suggested goals and features of redesigned systems for improved diagnosis (e.g., “aid cognition through aggregation, trending, contextual relevance, and minimizing of superfluous data”) tied to specific roles for that particular approach (e.g., “providing access to information”).20

What Are the Beneficial Effects of the Patient Safety Practice?

A recently published systematic review on system-related interventions addressing organizational vulnerabilities to diagnostic errors23 based on a search from 2000 to 2009 included 43 studies. A companion piece focused on cognitively-related interventions.24 To build on the previous work, we conducted a separate systematic review, encompassing a longer time period, and with broader inclusion criteria to provide a high-level summary of categories of interventions studied. We searched MEDLINE, PSNet, bibliographies of background articles and previous systematic reviews to identify literature about effects of practices with implications for errors and delays in diagnosis. For further detail, see Appendix C.

Although numerous articles proposed or described interventions, few reported evaluations of these interventions. Singh and colleagues summarized 37 studies with no evaluations, classifying them along five process dimensions: provider-patient encounter, diagnostic test performance and interpretation, follow-up and tracking, referral-related issues, and patient-related issues.23 Their review also identified six evaluations of interventions, of which only three reported diagnostic outcomes (incidence of delayed diagnosis of injury, incidence of missed injuries, misdiagnosis rates), and none provided information on patients' downstream clinical course.23

Graber and colleagues summarized 141 articles on improving congition and human factors affecting diagnosis, 42 of which reported evaluation of interventions.24 These investigators classified the literature along three dimensions. In the first dimension, interventions to increase knowledge and expertise, the authors identified seven evaluation studies, only one of which provided information on diagnostic outcomes and clinical course for actual patients. The second dimension included interventions to improve intuitive and deliberate considerations. Among the five studies evaluating interventions for this dimension, none reported resultant effects on documented diagnoses with actual patients during clinical course of care. In the largest group of studies, interventions assigned to the third dimension of getting help from colleagues, consultants and tools, 16 of 28 studies evaluated diagnostic outcomes in actual patients. Graber and colleagues note the current scarcity of evidence for any single intervention targeting cognitive and human factors in reducing diagnostic error. The authors highlighted potential for interventions that target content-focused training, feedback on performance, simulation-based training, metacognitive training, second opinion or group decision-making, and the use of decision support tools and computer-aided technologies.

Our review identified 94 studies of PSPs targeted at patient diagnosis. These studies reported missed diagnosis, misdiagnosis, delayed diagnosis, or some other diagnostic discrepency with potential for clinical consequence. The Supplementary Evidence Table (see Appendix D, Table 2) provides basic descriptions of targeted diagnostic errors, intervention descriptions, patient outcome, study design and results with respect to the effectiveness of the proposed interventions.

Drawing from frameworks proposed by others, we classified interventions into one or more of the following six types (Figure 1):

Figure 1 is a pie chart illustrating the percentage of studies in each of the six intervention categories: Technique, Educational Interventions, Technology-based Systems Interventions, Personnel Changes, Additional Review Methods, and Structured Process Changes.

Figure 1, Chapter 35

Interventions by type. This pie chart illustrates the percentage of studies as categorized to the six intervention types: Technique, Educational, Technology-Based Systems, Personnel Changes, Additional Review Methods, and Structured Process Changes.

  • Technique (introduction of novel technologies for testing, adaptations of testing equipment, or changes in medical interventions potentially affecting diagnostic performance)
  • Additional Review Methods (introduction of additional steps from the interpretation through reporting of test results)
  • Personnel Changes (introduction of additional health care members and/or replacing certain professionals with others)
  • Educational Interventions (implementation of educational strategies)
  • Structured Process Changes (implementation of feedback systems or additional stages in the diagnostic pathway)
  • Technology-based Systems Interventions (implementation of technology-based tools at the system level—computer assistive diagnostic aids, decision support algorithms, text message alerting, pager alerts, etc.)

All six of the evaluative studies identified by Singh and colleagues,23 many of the evaluative studies identified by Graber and colleagues,24 and most of the studies included in our systematic review, reported beneficial effects along the diagnostic pathway for a broad array of intervention types. Because the evidence is predominantly from uncontrolled before-after study designs or other uncontrolled study types (Table 1) with markedly different outcomes, the strength of the evidence about interventions to reduce diagnostic errors is insufficient to draw any strong conclusions. Furthermore, the magnitude of difference attributable to interventions varied by study and clinical process. For example, some researchers demonstrated what would be moderate-to-large effects on diagnosis if the assumption of causality were made (e.g., Perno and colleagues, 2005),25 although methodologies were not designed to test causality, whereas other studies were designed to demonstrate the absence of change in diagnostic outcomes despite intervention (e.g., Thomas and colleagues, 2003).26

Table 1, Chapter 35. Study design distribution.

Table 1, Chapter 35

Study design distribution.

As a result of the state of the science in this area, no meta-analyses have been conducted. Pooled analysis may be feasible in the near future as the evaluative literature is growing rapidly in some intervention categories. Figure 2 shows particular increases for several classes of interventions: Additional Review Methods, Technology-based Systems Interventions, and Structured Process Changes. The other intervention types have not been studied much over the entire period.

Figure 2 is a graph illustrating a timeline of the years of publication of the included studies according to the six intervention types. The X-axis spans the time period from 1970 to 2011. The Y-axis plots the number of studies for the following six intervention types: Additional Review Methods; Technology-based Systems Interventions; Structured Process Changes; Technique; Educational Interventions; and Personnel Changes.

Figure 2, Chapter 35

Intervention studies by year. The graph illustrates a timeline of the included studies broken down by the six intervention types.

Few studies (5 randomized, controlled trials and 8 other designs) have evaluated patient-level clinical outcomes to reduce diagnostic errors.9,27-38 Diagnostic errors have a complex relationship with direct patient outcomes because they can play a role at many different time points in a patient's care; that is, many opportunities exist to catch diagnostic errors. If a diagnostic error is caught at any of these opportunities, then negative effects on clinical outcomes could potentially be avoided. Thus, examining the direct relationship between diagnostic errors and clinical outcomes is complex and explains why many of the articles do not report on hard patient outcomes. The remainder of this section summarizes the findings of the review.

Results of Randomized, Controlled Trials

Primary and secondary comparative quantitative outcomes data were available in 13 randomized trials, and are summarized in Appendix Table 1 (See Appendix D). Seven trials (9 comparisons) addressed diagnostic accuracy outcomes, and 3 trials (5 comparisons) addressed outcomes related to further diagnostic test use. Six trials (8 comparisons) addressed outcomes related to further therapeutic management. Five trials (7 comparisons) addressed direct patient-related outcomes. Three trials addressed composite outcomes (diagnostic accuracy and therapeutic management, and therapeutic management and patient outcome). One trial addressed time to correct therapeutic management, and another trial addressed time to diagnosis.

Trials evaluated various interventions. The control group used most often was usual care. No trials had high risk of bias, whereas 9 and 5 trials had moderate and low risk of bias, respectively.

Statistically significant improvements were seen for at least 1 outcome in all but 3 trials. Of the 3 trials with non–statistically significant improvements, one was a noninferiority trial that showed no more diagnostic errors occurred during work-up of abdominal pain among patients given morphine and those not given morphine26. Two trials that involved patients with mental conditions38,39 reported no beneficial diagnostic error effects from computerized decision-support systems. Only 1 trial34 reported improvements in direct patient outcomes; whether improvements were related to the comparison against the randomized concurrent control group or a preintervention period was unclear.

Use of Additional Review Methods

The most common intervention type evaluated was the review of test interpretation (n=36).9,29-31,40-71 Most studies showed a positive impact on diagnostic performance of an additional review step (usually by a separate reader, sometimes from the same specialty and other times from another specialty). However, in some cases, the detection of errors came at a high cost in terms of additional false positives. Not all studies reported the tradeoffs between sensitivity and specificity. Some of the studies targeted higher risk patients for enriched review. However, the systems to support such targeting were neither described nor evaluated.

Diagnostic Techniques

The studies of interventions related to medical techniques (n=14)26,31,72-83 demonstrated that technologies as well as diagnostic test selection might either enhance diagnosis (e.g., visual enhancements via ultrasound-guided biopsy, changes to number of biopsy cores, cap-fitted colonoscopy) or impede it (e.g., medical interventions for pain relief in patients with abdominal pain). In the latter cases, the interventions hypothesized to impede diagnosis did not have that effect, and interventions expected to enhance diagnostic accuracy did not always do so.

Personnel Changes

Six studies36,37,67,69,84,85 compared the impact on diagnosis of substituting one type of professional for another, or adding another professional to the care team. The three studies67,69,85 that added a specialist to examine the interpretation of a test result reported an increase in case detection, although the studies were quite small and targeted narrow patient populations.

Educational Interventions

Ten studies employed educational interventions35,61-64,86-90 for various targets: consumers, community doctors, and intensive care unit doctors and nurses. Strategies targeted at professionals produced improvements. Only two studies targeted consumers (parents, candidates for screening) and both intervened on a behavior that occurs much earlier than actual diagnosis (e.g., awareness of symptom seriousness with the intent of reducing office visits in ways that would not adversely affect diagnosis)86

Structured Process Changes

Twenty six studies25,35,36,38,39,63,65,69,70,79-82,89,91-102 examined interventions that added structure to the diagnostic process; this structure included, among other things, triage protocols, feedback steps, and quality improvement processes (“Q-Track”, Toyota Production Process). Most interventions included the addition of a tool, often a checklist or a form (i.e., to guide and standardize physical examination of a patient). Some of the studies centered on laboratory processes, whereas others occurred during clinical management. Results were mixed for these types of interventions, with positive results (e.g., improved diagnosis) only among studies that were not randomized, controlled trials (RCTs). Two of the three RCTs tested interventions in mental health diagnosis.

Technology-Based Systems Interventions

Twenty nine studies9,27,28,32-34,103-117 included computerized decision support systems and alerting systems (e.g., for abnormal lab results), most associated with improvements to processes on the diagnostic pathway (e.g., critical laboratory value relayed to clinician in a more timely manner).

Some interventions related to specific symptoms (e.g., computer aided diagnostic tool for abdominal pain interpretation), while others intervened at the level of a particular test (e.g., electronic medical record alert for positive fecal occult blood (FOBT) cancer screening test results).

Studies With Interventions that Corresponded to Multiple Categories

Twenty-four studies9,31,35,36,38,61-63,65-70,79-83,85,89,90,102,118 combined approaches in a variety of ways and also covered a broad range of clinical areas, with mixed results. These studies are included in the categories above. Twenty of the 23 studies combined two categories of intervention in almost every permutation possible (11 of 15 combinations). All but three studies included at least one of the two predominant categories in this set of multiple category interventions: Additional Review Methods (11/23) and Structured Process Changes (13/23). With combined approaches comes an inherent complexity in the intervention. However, the results from studies of combined intervention strategies largely parallel those reported above. With only one to four studies for any combination set, it is not possible to draw any conclusions about whether benefits are enhanced with more complex interventions. In addition, these more complex approaches may be more costly, but this information was not reported.

Notifying Patients of Test Results

Another potential grouping of PSPs focuses on the interface between the system and the patient. Indeed interim care processes such as patient notification of test results has gained attention at the national level.119 However, no studies evaluated this intervention with comparative designs. The review by Singh and colleagues identified seven studies of patient preferences or satisfaction with different options for receipt of test results.23 However, they also found no studies that tested ways to reduce error using an intervention that affected test notification. One of the articles identified in the Singh review by Casalino and colleagues found a 7.1 percent rate of apparent failures to inform patients of an abnormal test result, and identified an association between use of simple processes by physician practices for managing results and lower failure rates.120 A systematic review of failures to follow-up test results with ambulatory care patients reported that failed follow-ups ranged from 1 percent to 62 percent depending on type of test result, and these failures were associated with missed cancer diagnoses. Electronic record systems appeared to exert a mild protective effect against failed follow-ups, although the authors note the pool of literature was small in this analysis.121

What Are the Harms of the Patient Safety Practice?

In general evaluations of PSPs have not assessed unintended adverse effects. However, some of the screening test literature is applicable to maintaining a balanced perspective on diagnostic error reduction. For example, an excluded study by Molins and colleagues122 reported on the negative effects of multiple mammogram screening (patient anxiety, higher costs, poorer subsequent screening attendance). Although this study did not involve an intervention to reduce diagnostic error per se, it was similar to some of the included interventions with added testing. Although none of the studies in our review evaluated direct patient harm, some reported false positive rates.

How Has the Patient Safety Practice Been Implemented, and In What Contexts?

The context in which a PSP is implemented depends on the specific type of diagnostic error and PSP being examined. The studies identified in our literature search covered a range of subspecialties, settings, and patient populations, with varying contexts. Most of the interventions studied have not been tested in more than one site, with some even more appropriately categorized as proof of concept. For diagnostic practice, another important context is the sequence of events and the role of time itself. Sometimes these factors are embedded in the patient safety target analyzed, as is the case for delayed diagnosis, which was an outcome in 26 studies included in the Appendix Supplementary Evidence Table.

Are There Any Data About Costs?

The main source of information about costs related to diagnostic error is derived from malpractice claims, as noted in an earlier section. In terms of costs of implementing some of the PSPs reviewed, no information was reported, but would likely range from low to high depending upon the PSP. For example, a PSP that involves an additional reviewer of imaging tests might double the cost of that step in the diagnostic process for all patients, meaning a relatively large investment per diagnostic error averted. For PSPs that compared the results of one technology to another, the cost might be more or less, though often, technologies that perform with greater accuracy cost more because they deliver a clinical benefit. For PSPs that revise a workflow to follow a structured process, the start-up cost would depend on whether a structured process is already available and can be adapted inexpensively or if workgroups have to spend significant time to reengineer a local process. In either case, the cost may still be relatively low compared with interventions that have ongoing incremental costs. Finally, information technology PSPs to reduce diagnostic errors may be relatively expensive, though these costs could vary as well.

Are There Any Data About the Effect of Context on Effectiveness?

The evidence base for this topic does not yet include an examination of the influence of contextual factors during implementation.

Conclusions and Comment

The original “Making Health Care Safer” report did not consider diagnostic errors because just a decade ago, few studies had quantified the prevalence and clinical consequence of this patient safety target. As a result, much of the literature over this period has focused on quantifying the scope of the problem, and elucidating potential causal pathways that result in failures in diagnosis. Very few intervention studies have tested strategies to reduce diagnostic errors. However, frameworks for filling in the evidence gaps are beginning to emerge.

This review identified over 90 evaluations of interventions to reduce diagnostic errors, many of which had a reported positive effect on at least one end point, including statistically significant improvements in at least one end point in 10 of the 13 randomized trials. Mortality and morbidity end points were seldom reported.

We also identified two previous systematic reviews of cognitive and systems-oriented approaches to improve diagnostic accuracy that mostly found proof-of-concept strategies not yet tested in practice. Our review built on the previous systematic reviews by grouping PSPs targeting diagnostic errors from an organizational perspective into changes that an organization might consider more generically (techniques investment; personnel configurations; additional review steps for higher reliability; structured processes; education of professionals, patients, families; and information and communications technology–based enhancements), as opposed to individual clinicians looking for ways to improve their own cognitive processing in specific diagnostic contexts. Although many of the PSPs tested thus far target diagnostic pathways for specific symptoms or conditions, grouping interventions into common leverage points will support future development in this field by the various stakeholders who seek to reduce diagnostic problems. Involvement of patients and families has received minimal attention, with only two studies addressing education of consumers.

Data synthesis is difficult because few studies have used randomized designs, comparable outcomes, or similar interventions packages. The existing literature may be susceptible to reporting biases favoring “positive” results for different interventions. It is expected that with heightened awareness of the problem, the number of studies in this field will increase further in the future, including more randomized trials and studies testing different approaches: for example, policy-level efforts. However, the range of outcomes assessed in the studies that we reviewed highlights the known lack of tools to routinely measure the effect of interventions to decrease diagnostic errors. Additional work is needed on appropriate measurements of diagnostic errors and consequential delays in diagnosis. A final limitation, especially for synthesis, is the diversity of interventions that are reverse-engineered on the basis of the many diagnostic targets; the diverse tailored needs for each clinical situation (for example, protocols designed for specific work-up pathways); and the variety of specialized personnel, and even patients, receiving educational or cognitive-support approaches.

Evidence is also lacking on the costs of interventions and implementation, particularly how to reduce diagnostic errors without producing other diagnostic problems, such as overuse of tests. Eventually reaching the correct diagnosis with inefficient testing strategies (for example, some sequences of multiple test ordering) is not the appropriate pathway to improved diagnostic safety. Our review found a paucity of studies that assessed both sensitivity and specificity of interventions addressing diagnostic performance in the context of mitigating diagnostic errors. Thus, although we found several promising interventions, evaluations need to be strengthened before any specific PSPs are scaled up in this domain.

Alongside the literature scoping the problem and generating ideas for potential solutions, some are also working on policy level efforts. Singh and Vij describe potential institutional-level policies for communicating test results within the clinical team and to the patient.123 These types of policies respond to national attention (e.g., the Joint Commission Patient Safety Goals), spotlighting this part of the diagnostic pathway as ripe for intervention. They note that the area of notifying patients about their test results is an emerging area for intervention testing.

In conclusion, our review demonstrates that the nascent field of diagnostic error research is growing, with new interventions being tested that involve technical, cognitive, and systems-oriented strategies. The framework of intervention types developed in the review provides a basis for categorizing and designing new studies, especially randomized, controlled trials, in these areas. A summary table is located below (Table 2).

Table 2, Chapter 35. Summary table.

Table 2, Chapter 35

Summary table.


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Cover of Making Health Care Safer II
Making Health Care Safer II: An Updated Critical Analysis of the Evidence for Patient Safety Practices.
Evidence Reports/Technology Assessments, No. 211.

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