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Making Health Care Safer: A Critical Review of Evidence Supporting Strategies to Improve Patient Safety
5 March 2013

Patient Safety Strategies Targeted at Diagnostic Errors: A Systematic ReviewFREE

Publication: Annals of Internal Medicine
Volume 158, Number 5_Part_2


Missed, delayed, or incorrect diagnosis can lead to inappropriate patient care, poor patient outcomes, and increased cost. This systematic review analyzed evaluations of interventions to prevent diagnostic errors. Searches used MEDLINE (1966 to October 2012), the Agency for Healthcare Research and Quality's Patient Safety Network, bibliographies, and prior systematic reviews. Studies that evaluated any intervention to decrease diagnostic errors in any clinical setting and with any study design were eligible, provided that they addressed a patient-related outcome. Two independent reviewers extracted study data and rated study quality.
There were 109 studies that addressed 1 or more intervention categories: personnel changes (n = 6), educational interventions (n = 11), technique (n = 23), structured process changes (n = 27), technology-based systems interventions (n = 32), and review methods (n = 38). Of 14 randomized trials, which were rated as having mostly low to moderate risk of bias, 11 reported interventions that reduced diagnostic errors. Evidence seemed strongest for technology-based systems (for example, text message alerting) and specific techniques (for example, testing equipment adaptations). Studies provided no information on harms, cost, or contextual application of interventions. Overall, the review showed a growing field of diagnostic error research and categorized and identified promising interventions that warrant evaluation in large studies across diverse settings.

Key Summary Points

Missed, delayed, or incorrect diagnosis can lead to inappropriate patient care, poor patient outcomes, and increased cost.
Patient safety strategies targeting diagnostic errors have only recently been studied.
Approaches to reduce errors may involve technical, cognitive, and systems-oriented strategies tailored to specific conditions or settings.
A framework that organizations might use to classify intervention strategies aimed at reducing diagnostic errors includes technique, personnel, education, structured process, technology-based systems, and review methods.
Limited evidence from randomized, controlled trials shows that some interventions, such as text messaging—a technology-based systems strategy—can reduce diagnostic errors in certain situations.
Very few studies of interventions to reduce diagnostic errors have examined clinical outcomes (for example, morbidity, mortality) or evaluated the utility of engaging patients and families in prevention of diagnostic errors.

The Problem

The family of patient safety targets that includes diagnostic errors has unclear boundaries. An operational definition includes diagnoses that are “unintentionally delayed (sufficient information was available earlier), wrong (another diagnosis was made before the correct one), or missed (no diagnosis was ever made), as judged from the eventual appreciation of more definitive information” (1, 2).
Although the definition is a bit fluid, there is no doubt that the scope of the problem is large. A systematic review of 53 series of autopsies reported a median antemortem error rate of 23.5% (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% (range, 0% to 20.7%) for incorrect diagnoses that are likely to have affected patient outcomes (3). Disease-specific studies show that 2% to 61% of patients experience missed or delayed diagnoses (4). In a survey of pediatricians, 54% admitted making a diagnostic error at least once per month, and 45% noted making diagnostic errors that harmed patients at least once per year (5). Lack of pertinent historical or clinical information and team processes (for example, inadequate care coordination) contributed to errors (5).
Furthermore, research on variation in patient outcomes related to diagnosis timing suggests that there is room for improvement for some high-risk conditions. For example, early identification of sepsis may decrease mortality in surgical intensive care (6).
Problems in care related to diagnosis are particularly prevalent among precipitating causes for lawsuits; 25% to 59% of malpractice claims are attributable to diagnostic errors (4, 7, 8). A recent study of 91 082 diagnosis-related malpractice claims from 1986 to 2005 estimated payments summing to $34.5 billion (inflation-adjusted to 2010 U.S. dollars) (9). Among 10 739 malpractice claims from the 2005–2009 National Practitioner Data Bank, diagnosis-related problems accounted for 45.9% of paid claims from outpatient settings and 21.1% of paid claims from inpatient settings (10).
Some authors have asserted that diagnostic errors are both more likely to result in patient harms and more preventable than treatment-related errors (such as wrong-site surgery or incorrect medication dose), making the problem particularly important to address (11). Given this potential, the purpose of this review is to assess the multitude of interventions to prevent diagnostic errors and better understand their effectiveness.

Patient Safety Strategies

There is a broad array of patient safety strategies (PSSs) that could affect diagnostic errors. Approaches might involve technical, cognitive, and systems-oriented strategies, usually tailored to specific conditions or settings.
Strategies might address specific types of diagnostic error, root causes of the error, or particular technologies that are available. Strategies might target clinician errors related to assessment (for example, failure or delay in considering an important diagnosis) or laboratory and radiology testing (including failure to order needed tests, technical errors in processing specimens or tests, or erroneous reading of tests) (2). Interventions that target such failure areas might include tools that generate differential diagnosis lists based on algorithms and checklists; electronic monitoring of test result follow-up; and redesigned documentation systems that efficiently aggregate relevant evidence and aid cognitive interpretation (2). Broad-based strategies might target changes in residency training, board certification, and even patient and family engagement in diagnostic problem solving.
Finally, many strategies could incorporate advances in medical problem solving (including heuristics and metacognition), decision analytic or normative decision making, and clinical diagnostic decision support (12–14). Strategies in this area—computerized diagnosis management—could include computerized physician order entry with clinical decision support.

Review Processes

We captured relevant literature for review through 2 main mechanisms. First, we identified 2 key systematic reviews that summarized data on system-related interventions addressing organizational vulnerabilities to diagnostic errors (15) and cognitively related interventions that could affect diagnosis (16). Then, we used broad search strategies to identify additional literature. We searched MEDLINE (1966 to October 2012), the Agency for Healthcare Research and Quality (AHRQ) Patient Safety Network (, and bibliographies of background articles and previous systematic reviews to identify literature on effects of interventions targeting diagnostic errors and/or diagnostic delays. The major Medical Subject Heading terms were “diagnostic errors” and “delayed diagnosis.”
Eligible studies were those that evaluated any intervention to decrease diagnostic errors (incorrect diagnoses or missed diagnoses) in any clinical setting and with any study design, provided that they addressed patient-related outcomes (that is, the correct diagnosis was eventually confirmed through patient follow-up testing, surgery, autopsy, or other means) or proxy measures of patient-related outcomes. We also considered studies that evaluated interventions intended to affect the time to correct diagnosis or appropriate clinical action. We excluded studies in which there was no intervention or no real patients (for example, simulations), the intervention was not aimed to reduce diagnostic errors, or there were no patient outcomes or proxies thereof.
Two independent investigators screened articles for eligibility at the title and abstract level, and any discrepancies about selection were resolved through discussion with the entire research team. We also screened all of the studies included in the reviews by Singh and colleagues (15) and Graber and associates (16) and identified 23 studies that were evaluations of interventions.
In total, we identified 109 articles that met inclusion criteria. The Supplement provides a complete description of the search strategies, article flow diagram, and evidence tables.
We used AMSTAR, a tool that addresses such items as the comprehensiveness of the search, the assessment of the quality of included studies, and the methods for synthesizing the results, to assess the methodological quality of the 2 key systematic reviews (17). We used a standard risk of bias assessment to evaluate quality of the randomized trials (Table 3 of the Supplement) (18). We developed and used a categorization scheme to classify, from an organizational perspective, interventions that target diagnostic errors (Table). Categories included changes that an organization might consider generically to reduce errors. Such changes include techniques investment; personnel configurations; additional review steps for higher reliability; structured processes; education of professionals, patients, and families; and information and communications technology–based enhancements.
Table. Categories of Organizational Interventions to Decrease Diagnostic Errors
Table. Categories of Organizational Interventions to Decrease Diagnostic Errors
This review was supported by the AHRQ, which had no role in the selection or review of the evidence or the decision to submit this manuscript for publication.

Benefits and Harms


Prior Systematic Reviews

Singh and colleagues (15) considered 43 diagnostic error studies of systems interventions related to provider–patient encounters, diagnostic test performance and interpretation, follow-up and tracking, referral-related issues, and patient-related issues. Their high-quality review (score of 9 out of 9 relevant AMSTAR criteria) identified only 6 evaluations of interventions that met eligibility criteria for our review. Three of the 6 reported diagnostic outcomes, such as incidence of delayed diagnosis of injury, incidence of missed injuries, or misdiagnosis rates. None provided information on patients' downstream clinical course.
Graber and colleagues (16) summarized 141 articles on improving cognition and human factors affecting diagnosis. Their high-quality review (score of 9 out of 9 relevant AMSTAR criteria) included 42 evaluations of interventions. These investigators classified interventions in 3 dimensions. For interventions to increase knowledge and expertise, only 1 (19) of 7 studies provided information on diagnostic outcomes and clinical course for actual patients. For interventions to improve intuitive and deliberate considerations, none of the 5 identified studies reported effects on documented diagnoses with actual patients during clinical course of care. In the largest group of studies—interventions on getting help from colleagues, consultants, and tools—16 of the 28 identified studies evaluated diagnostic outcomes in actual patients (20–35).
Graber and colleagues noted the current scarcity of evidence for any single intervention targeting cognitive and human factors in reducing diagnostic error. They 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.

Studies of PSS Evaluations

We identified 109 studies, including 14 randomized trials, of interventions that targeted diagnostic errors and addressed patient-related outcomes (see Tables 1 to 4 of the Supplement). Of the 6 categories of interventions, most studies pertained to interventions in the categories of technology-based systems and additional review methods (Figure 1). Figure 2 shows increases over time in available evidence related to the categories of additional review methods, structured process changes, technique, and technology-based systems interventions.
Figure 1. Interventions, by type.  The percentage of studies as categorized by the 6 types of interventions.
Figure 1. Interventions, by type.
The percentage of studies as categorized by the 6 types of interventions.
Figure 2. Intervention studies, by year.  Timeline of the included studies categorized by the 6 types of interventions.
Figure 2. Intervention studies, by year.
Timeline of the included studies categorized by the 6 types of interventions.
Patient-related outcomes and their proxies can be categorized as diagnostic accuracy outcomes (for example, false-positive and false-negative results), management outcomes (for example, use of further diagnostic tests or therapeutic interventions), and direct patient outcomes (for example, death, disease progression, or deterioration). An intervention that leads to better diagnosis does not automatically change management or improve patient outcomes. Management change depends on treatment options and the feasibility of implementing those options. Improvements in direct patient outcomes depend also on effectiveness of treatment or management. Outcomes that were assessed in the 109 studies varied markedly, but few studies (5 randomized, controlled trials and 8 other designs) evaluated direct patient-level clinical outcomes (6, 31, 36–46).

Results of Randomized, Controlled Trials

Primary and secondary outcomes that were assessed in the 14 randomized trials are summarized in Table 2 of the Supplement. Eight 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, 1 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 morphine (47). Two trials that involved patients with mental conditions (46, 48) reported no beneficial diagnostic error effects from computerized decision-support systems. Only 1 trial (42) 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.


There were 23 studies of interventions related to medical techniques (39, 47, 49–69). Most of these studies, including 3 randomized trials (47, 49, 55), found that these interventions can enhance diagnosis (for example, visual enhancements via ultrasonography-guided biopsy, changes to number of biopsy cores, and cap-fitted colonoscopy) or not make it worse (for example, medical interventions for pain relief in patients with abdominal pain).

Personnel Changes

Six studies (44, 45, 70–73) compared the effect on diagnosis of substituting 1 type of professional for another, or adding another professional to the care team. The 3 studies (71–73) in which a specialist was added 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. There was only 1 randomized trial, showing that emergency nurse practitioners perform better than junior physicians (45).

Educational Interventions

Eleven studies (19, 43, 74–82) used educational interventions for various targets: patients, parents, community doctors, and intensive care unit doctors and nurses. Strategies targeted at professionals produced improvements, but the studies were nonrandomized. Two randomized trials that targeted consumers found that parent education improved discrimination of serious symptoms necessitating physician diagnosis and patient education improved the performance of breast cancer screening (74, 78).

Structured Process Changes

Twenty-seven studies (43, 44, 46, 48, 56–59, 73, 77, 79, 83–98) examined interventions that added structure to the diagnostic process. Structure included, among other things, triage protocols, feedback steps, and quality improvement processes. Most interventions included the addition of a tool, often a checklist or a form (for example, to guide and standardize physical examination of a patient). Some of the studies centered on laboratory processes, whereas others occurred during clinical management, often in situations related to trauma patients. Beneficial effects on diagnosis-related outcomes were seen in most nonrandomized studies, but of the 3 randomized trials, 2 did not show benefit for improving diagnosis of mental illness (46, 48) and 1 had mixed results for a protocol for ordering radiography in injured patients (84).

Technology-Based Systems Interventions

Thirty-two studies (6, 29–36, 40–42, 44, 46, 60, 71, 78, 80, 97, 99–111) included computerized decision support systems and alerting systems (for example, for abnormal laboratory results), most of which were associated with improvements to processes on the diagnostic pathway (for example, relaying a critical laboratory value to the clinician in a more timely manner). Some interventions related to specific symptoms (for example, a computer-aided diagnostic tool for abdominal pain interpretation), whereas others intervened at the level of a particular test (for example, an electronic medical record alert for a positive result on a fecal occult blood screen for cancer). All 4 randomized trials (31, 36, 42, 100) reported beneficial diagnostic error effects (see Table 2 of the Supplement).

Additional Review Methods

The most common type of intervention that was evaluated was the introduction of redundancy in interpreting test results (6, 20–28, 34, 37–39, 72, 73, 76, 78, 79, 81, 95, 96, 109, 112–126). Most studies showed that an additional review step (usually by a separate reader, from the same specialty or from another specialty) had a positive effect on diagnostic performance. However, in some cases, false-positive results also increased. Tradeoffs between sensitivity and specificity were reported erratically. Some studies targeted higher-risk patients for enriched review. However, the systems to support such targeting were neither described nor evaluated. Randomized evidence was weak, based on 1 group of 1 trial showing statistically significant benefit (no effect size reported) for an audit and feedback approach (78).

Studies With Interventions That Corresponded to Multiple Categories

Twenty-four studies (6, 34, 39, 43, 44, 46, 56–60, 71–73, 76–80, 95–97, 109, 127) combined approaches in a variety of ways and covered diverse clinical areas, with mixed results. These studies are also included in the categories covered above. Twenty of the 24 studies combined 2 categories of intervention in almost every permutation possible (11 of 15 combinations). With only 1 to 4 studies for any combination set, it is not possible to draw conclusions about whether benefits are enhanced with more complex interventions. Moreover, complex approaches may be more costly, but this information was not reported.

Notifying Patients of Test Results

Another potential grouping of PSSs focuses on the interface between the system and the patient, such as strategies that involve patient notification of test results (128). No studies with comparative designs evaluated this intervention. The review by Singh and colleagues (15) identified 7 studies of patient preferences or satisfaction with different options for receipt of test results. They also found no studies that tested ways to reduce error using an intervention that affected test notification.
Casalino and colleagues (129) found a 7.1% rate of apparent failures to inform patients of an abnormal test result and identified a positive association between use of simple processes by physician practices for managing results and lower failure rates. A systematic review that examined failures to follow up test results with ambulatory care patients reported that failed follow-up ranged from 1.0% to 62.0%, depending on the type of test result, including failures associated with missed cancer diagnoses (130). None of the studies included in that systematic review evaluated patient-oriented interventions.


No studies in our review evaluated direct patient harm. Studies generally did not assess unintended adverse effects, although some reported false-positive rates.

Implementation Considerations and Costs

The context in which a safety strategy is implemented depends on the specific type of diagnostic error and practice being examined. The studies that we reviewed covered a range of subspecialties, settings, patient populations, and interventions. Context varied greatly. Most interventions were not tested in more than 1 site. Many studies were small, early proof-of-concept evaluations. No information was reported on the cost of implementing the reviewed PSSs; costs would probably vary greatly, depending on the particular strategy or practice.


This review identified over 100 evaluations of interventions to reduce diagnostic errors, many of which had a reported positive effect on at least 1 end point, including statistically significant improvements in at least 1 end point in 11 of the 14 randomized trials. Mortality and morbidity end points were seldom reported.
We also identified 2 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 PSSs 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 PSSs 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 2 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 PSSs are scaled up in this domain.
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.

Supplemental Material

Supplement. Patient Safety Strategies Targeted at Diagnostic Errors


Graber ML. Next steps: envisioning a research agenda. Adv Health Sci Educ Theory Pract. 2009;14 Suppl 1 107-12. [PMID: 19669917]
Schiff GDHasan OKim SAbrams RCosby KLambert BLet al. Diagnostic error in medicine: analysis of 583 physician-reported errors. Arch Intern Med. 2009;169:1881-7. [PMID: 19901140]
Shojania KGBurton ECMcDonald KMGoldman L. Changes in rates of autopsy-detected diagnostic errors over time: a systematic review. JAMA. 2003;289:2849-56. [PMID: 12783916]
Schiff GDKim SAbrams RCosby KLambert BElstein ASet al. Diagnosing diagnosis errors: lessons from a multi-institutional collaborative project. In: Henriksen K, Battles JB, Marks ES, Lewin DI, eds. Advances in Patient Safety: From Research to Implementation. vol 2. Rockville, MD: Agency for Healthcare Research and Quality; 2005.
Singh HThomas EJWilson LKelly PAPietz KElkeeb Det al. Errors of diagnosis in pediatric practice: a multisite survey. Pediatrics. 2010;126:70-9. [PMID: 20566604]
Moore LJJones SLKreiner LAMcKinley BSucher JFTodd SRet al. Validation of a screening tool for the early identification of sepsis. J Trauma. 2009;66:1539-46. [PMID: 19509612]
Phillips RL JrBartholomew LADovey SMFryer GE JrMiyoshi TJGreen LA. Learning from malpractice claims about negligent, adverse events in primary care in the United States. Qual Saf Health Care. 2004;13:121-6. [PMID: 15744204]
Selbst SM. Pediatric emergency medicine: legal briefs. Pediatr Emerg Care. 2005;21:214-8.
Tehrani AS, Lee H, Mathews S, Shore A, Frick KD, Makary M, et al. 20-year summary of U.S. malpractice claims for diagnostic errors from 1985-2005 [Abstract]. 33rd Annual Meeting of the Society for Medical Decision Making, Chicago, Ilinois, 22–26 October 2011.
Bishop TFRyan AMCasalino LP. Paid malpractice claims for adverse events in inpatient and outpatient settings. JAMA. 2011;305:2427-31. [PMID: 21673294]
Ely JWGraber MLCroskerry P. Checklists to reduce diagnostic errors. Acad Med. 2011;86:307-13. [PMID: 21248608]
Cosby KS. A framework for classifying factors that contribute to error in the emergency department. Ann Emerg Med. 2003;42:815-23. [PMID: 14634609]
Tversky AKahneman D. Judgment under uncertainty: heuristics and biases. Science. 1974;185:1124-31. [PMID: 17835457]
Metcalfe JShimamura AP. Metacognition: Knowing About Knowing. Cambridge, MA: MIT Press; 1994.
Singh HGraber MLKissam SMSorensen AVLenfestey NFTant EMet al. System-related interventions to reduce diagnostic errors: a narrative review. BMJ Qual Saf. 2012;21:160-70. [PMID: 22129930]
Graber MLKissam SPayne VLMeyer ANSorensen ALenfestey Net al. Cognitive interventions to reduce diagnostic error: a narrative review. BMJ Qual Saf. 2012;21:535-57. [PMID: 22543420]
Shea BJGrimshaw JMWells GABoers MAndersson NHamel Cet al. Development of AMSTAR: a measurement tool to assess the methodological quality of systematic reviews. BMC Med Res Methodol. 2007;7:10. [PMID: 17302989]
Assessing risk of bias in included studies. In: Higgins JP, Green S, eds. Cochrane Handbook for Systematic Reviews of Interventions. Version 5.0.1. The Cochrane Collaboration; September 2008. Accessed at on 6 September 2012.
Fridriksson SHillman JLandtblom AMBoive J. Education of referring doctors about sudden onset headache in subarachnoid hemorrhage. A prospective study. Acta Neurol Scand. 2001;103:238-42. [PMID: 11328195]
Raab SSStone CHJensen CSZarbo RJMeier FAGrzybicki DMet al. Double slide viewing as a cytology quality improvement initiative. Am J Clin Pathol. 2006;125:526-33. [PMID: 16627263]
Raab SSGrzybicki DMMahood LKParwani AVKuan SFRao UN. Effectiveness of random and focused review in detecting surgical pathology error. Am J Clin Pathol. 2008;130:905-12. [PMID: 19019767]
Manion ECohen MBWeydert J. Mandatory second opinion in surgical pathology referral material: clinical consequences of major disagreements. Am J Surg Pathol. 2008;32:732-7. [PMID: 18360282]
Nordrum IJohansen MAmin AIsaksen VLudvigsen JA. Diagnostic accuracy of second-opinion diagnoses based on still images. Hum Pathol. 2004;35:129-35. [PMID: 14745735]
Hamady ZZMather NLansdown MRDavidson LMaclennan KA. Surgical pathological second opinion in thyroid malignancy: impact on patients' management and prognosis. Eur J Surg Oncol. 2005;31:74-7. [PMID: 15642429]
Espinosa JANolan TW. Reducing errors made by emergency physicians in interpreting radiographs: longitudinal study. BMJ. 2000;320:737-40. [PMID: 10720354]
Duijm LEGroenewoud JHFracheboud Jde Koning HJ. Additional double reading of screening mammograms by radiologic technologists: impact on screening performance parameters. J Natl Cancer Inst. 2007;99:1162-70. [PMID: 17652282]
Kwek BHLau TNNg FCGao F. Non-consensual double reading in the Singapore Breast Screening Project: benefits and limitations. Ann Acad Med Singapore. 2003;32:438-41. [PMID: 12968545]
Canon CLSmith JKMorgan DEJones BCFell SCKenney PJet al. Double reading of barium enemas: is it necessary? AJR Am J Roentgenol. 2003;181:1607-10. [PMID: 14627582]
Pozen MWD'Agostino RBSelker HPSytkowski PAHood WB Jr. A predictive instrument to improve coronary-care-unit admission practices in acute ischemic heart disease. A prospective multicenter clinical trial. N Engl J Med. 1984;310:1273-8. [PMID: 6371525]
Selker HPBeshansky JRGriffith JLAufderheide TPBallin DSBernard SAet al. Use of the acute cardiac ischemia time-insensitive predictive instrument (ACI-TIPI) to assist with triage of patients with chest pain or other symptoms suggestive of acute cardiac ischemia. A multicenter, controlled clinical trial. Ann Intern Med. 1998;129:845-55. [PMID: 9867725]
Bogusevicius AMaleckas APundzius JSkaudickas D. Prospective randomised trial of computer-aided diagnosis and contrast radiography in acute small bowel obstruction. Eur J Surg. 2002;168:78-83. [PMID: 12113275]
Ramnarayan PWinrow ACoren MNanduri VBuchdahl RJacobs Bet al. Diagnostic omission errors in acute paediatric practice: impact of a reminder system on decision-making. BMC Med Inform Decis Mak. 2006;6:37. [PMID: 17087835]
Olsson SEOhlsson MOhlin HDzaferagic SNilsson MLSandkull Pet al. Decision support for the initial triage of patients with acute coronary syndromes. Clin Physiol Funct Imaging. 2006;26:151-6. [PMID: 16640509]
Peldschus KHerzog PWood SACheema JICostello PSchoepf UJ. Computer-aided diagnosis as a second reader: spectrum of findings in CT studies of the chest interpreted as normal. Chest. 2005;128:1517-23. [PMID: 16162752]
Kakeda SMoriya JSato HAoki TWatanabe HNakata Het al. Improved detection of lung nodules on chest radiographs using a commercial computer-aided diagnosis system. AJR Am J Roentgenol. 2004;182:505-10. [PMID: 14736690]
Kuperman GJTeich JMTanasijevic MJMa'Luf NRittenberg EJha Aet al. Improving response to critical laboratory results with automation: results of a randomized controlled trial. J Am Med Inform Assoc. 1999;6:512-22. [PMID: 10579608]
Dudley MChanner KS. Assessment of the value of technician reporting of electrocardiographs in an accident and emergency department. J Accid Emerg Med. 1997;14:307-10. [PMID: 9315933]
Nam YSPikarsky AJWexner SDSingh JJWeiss EGNogueras JJet al. Reproducibility of colonic transit study in patients with chronic constipation. Dis Colon Rectum. 2001;44:86-92. [PMID: 11805568]
Beigi BUddin JMMcMullan TFLinardos E. Inaccuracy of diagnosis in a cohort of patients on the waiting list for dacryocystorhinostomy when the diagnosis was made by only syringing the lacrimal system. Eur J Ophthalmol. 2007;17:485-9. [PMID: 17671919]
Major KShabot MMCunneen S. Wireless clinical alerts and patient outcomes in the surgical intensive care unit. Am Surg. 2002;68:1057-60. [PMID: 12516808]
Etchells EAdhikari NKWu RCheung MQuan SMraz Ret al. Real-time automated paging and decision support for critical laboratory abnormalities. BMJ Qual Saf. 2011;20:924-30. [PMID: 21725046]
Fitzgerald MCameron PMackenzie CFarrow NScicluna PGocentas Ret al. Trauma resuscitation errors and computer-assisted decision support. Arch Surg. 2011;146:218-25. [PMID: 21339436]
Chern CHHow CKWang LMLee CHGraff L. Decreasing clinically significant adverse events using feedback to emergency physicians of telephone follow-up outcomes. Ann Emerg Med. 2005;45:15-23. [PMID: 15635301]
Vernon DDFurnival RAHansen KWDiller EMBolte RGJohnson DGet al. Effect of a pediatric trauma response team on emergency department treatment time and mortality of pediatric trauma victims. Pediatrics. 1999;103:20-4. [PMID: 9917434]
Sakr MAngus JPerrin JNixon CNicholl JWardrope J. Care of minor injuries by emergency nurse practitioners or junior doctors: a randomised controlled trial. Lancet. 1999;354:1321-6. [PMID: 10533859]
Rollman BLHanusa BHLowe HJGilbert TKapoor WNSchulberg HC. A randomized trial using computerized decision support to improve treatment of major depression in primary care. J Gen Intern Med. 2002;17:493-503. [PMID: 12133139]
Thomas SHSilen WCheema FReisner AAman SGoldstein JNet al. Effects of morphine analgesia on diagnostic accuracy in emergency department patients with abdominal pain: a prospective, randomized trial. J Am Coll Surg. 2003;196:18-31. [PMID: 12517545]
Schriger DLGibbons PSLangone CALee SAltshuler LL. Enabling the diagnosis of occult psychiatric illness in the emergency department: a randomized, controlled trial of the computerized, self-administered PRIME-MD diagnostic system. Ann Emerg Med. 2001;37:132-40. [PMID: 11174229]
Attard ARCorlett MJKidner NJLeslie APFraser IA. Safety of early pain relief for acute abdominal pain. BMJ. 1992;305:554-6. [PMID: 1393034]
Resnick NMBrandeis GHBaumann MMDuBeau CEYalla SV. Misdiagnosis of urinary incontinence in nursing home women: prevalence and a proposed solution. Neurourol Urodyn. 1996;15:599-613. [PMID: 8916113]
Borgstein PJGordijn RVEijsbouts QACuesta MA. Acute appendicitis—a clear-cut case in men, a guessing game in young women. A prospective study on the role of laparoscopy. Surg Endosc. 1997;11:923-7. [PMID: 9294274]
Vermeulen BMorabia AUnger PFGoehring CGrangier CSkljarov Iet al. Acute appendicitis: influence of early pain relief on the accuracy of clinical and US findings in the decision to operate—a randomized trial. Radiology. 1999;210:639-43. [PMID: 10207461]
Prieto VGArgenyi ZBBarnhill RLDuray PHElenitsas RFrom Let al. Are en face frozen sections accurate for diagnosing margin status in melanocytic lesions? Am J Clin Pathol. 2003;120:203-8. [PMID: 12931550]
Kokki HLintula HVanamo KHeiskanen MEskelinen M. Oxycodone vs placebo in children with undifferentiated abdominal pain: a randomized, double-blind clinical trial of the effect of analgesia on diagnostic accuracy. Arch Pediatr Adolesc Med. 2005;159:320-5. [PMID: 15809382]
Hewett DGRex DK. Cap-fitted colonoscopy: a randomized, tandem colonoscopy study of adenoma miss rates. Gastrointest Endosc. 2010;72:775-81. [PMID: 20579648]
Brössner CMadersbacher SBayer GPycha AKlingler HCMaier U. Comparative study of two different TRUS-guided sextant biopsy techniques in detecting prostate cancer in one biopsy session. Eur Urol. 2000;37:65-71. [PMID: 10671788]
Naughton CKMiller DCMager DEOrnstein DKCatalona WJ. A prospective randomized trial comparing 6 versus 12 prostate biopsy cores: impact on cancer detection. J Urol. 2000;164:388-92. [PMID: 10893592]
Presti JC JrChang JJBhargava VShinohara K. The optimal systematic prostate biopsy scheme should include 8 rather than 6 biopsies: results of a prospective clinical trial. J Urol. 2000;163:163-6. [PMID: 10604337]
Ravery VGoldblatt LRoyer BBlanc EToublanc MBoccon-Gibod L. Extensive biopsy protocol improves the detection rate of prostate cancer. J Urol. 2000;164:393-6. [PMID: 10893593]
Weatherburn GBryan SNicholas ACocks R. The effect of a picture archiving and communications system (PACS) on diagnostic performance in the accident and emergency department. J Accid Emerg Med. 2000;17:180-4. [PMID: 10819379]
Johnson AJZywiel MGStroh AMarker DRMont MA. Serological markers can lead to false negative diagnoses of periprosthetic infections following total knee arthroplasty. Int Orthop. 2011;35:1621-6. [PMID: 21181540]
Larson EMO'Donnell MChamblee SHorsburgh CR JrMarsh BJMoreland JDet al. Dual skin tests with Mycobacterium avium sensitin and PPD to detect misdiagnosis of latent tuberculosis infection. Int J Tuberc Lung Dis. 2011;15:1504-9, i. [PMID: 22008764]
Maclean JESolomon MCorey MSelvadurai H. Cystic fibrosis newborn screening does not delay the identification of cystic fibrosis in children with negative results. J Cyst Fibros. 2011;10:333-7. [PMID: 21536503]
Bachur RGHennelly KCallahan MJChen CMonuteaux MC. Diagnostic imaging and negative appendectomy rates in children: effects of age and gender. Pediatrics. 2012;129:877-84. [PMID: 22508920]
Zheng YHawkins LWolff JGoloubeva OGoldberg E. Detection of lesions during capsule endoscopy: physician performance is disappointing. Am J Gastroenterol. 2012;107:554-60. [PMID: 22233695]
Garcia EALopez JRMeier JLSwislocki ALSiegel D. Resistant hypertension and undiagnosed primary hyperaldosteronism detected by use of a computerized database. J Clin Hypertens (Greenwich). 2011;13:487-91. [PMID: 21762361]
Piliouras PAllison SRosendahl CBuettner PGWeedon D. Dermoscopy improves diagnosis of tinea nigra: a study of 50 cases. Australas J Dermatol. 2011;52:191-4. [PMID: 21834814]
Leufkens AMDeMarco DCRastogi AAkerman PAAzzouzi KRothstein RIet alThird Eye Retroscope Randomized Clinical Evaluation [TERRACE] Study Group. Effect of a retrograde-viewing device on adenoma detection rate during colonoscopy: the TERRACE study. Gastrointest Endosc. 2011;73:480-9. [PMID: 21067735]
Kline JAHogg MMCourtney DMMiller CDJones AESmithline HA. D-dimer threshold increase with pretest probability unlikely for pulmonary embolism to decrease unnecessary computerized tomographic pulmonary angiography. J Thromb Haemost. 2012;10:572-81. [PMID: 22284935]
de Lacey GBarker AHarper JWignall B. An assessment of the clinical effects of reporting accident and emergency radiographs. Br J Radiol. 1980;53:304-9. [PMID: 7378697]
Jacobs MJEdmondson MJLowry JC. Accuracy of diagnosis of fractures by maxillofacial and accident and emergency doctors using plain radiography compared with a telemedicine system: a prospective study. Br J Oral Maxillofac Surg. 2002;40:156-62. [PMID: 12180212]
Trotter MJBruecks AK. Interpretation of skin biopsies by general pathologists: diagnostic discrepancy rate measured by blinded review. Arch Pathol Lab Med. 2003;127:1489-92. [PMID: 14567717]
Tsai JJYeun JYKumar VADon BR. Comparison and interpretation of urinalysis performed by a nephrologist versus a hospital-based clinical laboratory. Am J Kidney Dis. 2005;46:820-9. [PMID: 16253721]
McCarthy PLSznajderman SDLustman-Findling KBaron MAFink HDCzarkowski Net al. Mothers' clinical judgment: a randomized trial of the Acute Illness Observation Scales. J Pediatr. 1990;116:200-6. [PMID: 2405140]
Thaler TTempelmann VMaggiorini MRudiger A. The frequency of electrocardiographic errors due to electrode cable switches: a before and after study. J Electrocardiol. 2010;43:676-81. [PMID: 20591441]
Seltzer SEHessel SJHerman PGSwensson RGSheriff CR. Resident film interpretations and staff review. AJR Am J Roentgenol. 1981;137:129-33. [PMID: 6787863]
Gleadhill DNThomson JYSimms P. Can more efficient use be made of x ray examinations in the accident and emergency department? Br Med J (Clin Res Ed). 1987;294:943-7. [PMID: 3107669]
McPhee SJBird JAJenkins CNFordham D. Promoting cancer screening. A randomized, controlled trial of three interventions. Arch Intern Med. 1989;149:1866-72. [PMID: 2764657]
Kundel HLNodine CFKrupinski EA. Computer-displayed eye position as a visual aid to pulmonary nodule interpretation. Invest Radiol. 1990;25:890-6. [PMID: 2394571]
Linver MNPaster SBRosenberg RDKey CRStidley CAKing WV. Improvement in mammography interpretation skills in a community radiology practice after dedicated teaching courses: 2-year medical audit of 38,633 cases. Radiology. 1992;184:39-43. [PMID: 1609100]
Thomas HGMason ACSmith RMFergusson CM. Value of radiograph audit in an accident service department. Injury. 1992;23:47-50. [PMID: 1541500]
Itri JNKang HCKrishnan SNathan DScanlon MH. Using focused missed-case conferences to reduce discrepancies in musculoskeletal studies interpreted by residents on call. AJR Am J Roentgenol. 2011;197:W696-705. [PMID: 21940542]
Enderson BLReath DBMeadors JDallas WDeBoo JMMaull KI. The tertiary trauma survey: a prospective study of missed injury. J Trauma. 1990;30:666-9. [PMID: 2352294]
Klassen TPRopp LJSutcliffe TBlouin RDulberg CRaman Set al. A randomized, controlled trial of radiograph ordering for extremity trauma in a pediatric emergency department. Ann Emerg Med. 1993;22:1524-9. [PMID: 8214829]
Biffl WLHarrington DTCioffi WG. Implementation of a tertiary trauma survey decreases missed injuries. J Trauma. 2003;54:38-43. [PMID: 12544897]
Soundappan SVHolland AJCass DT. Role of an extended tertiary survey in detecting missed injuries in children. J Trauma. 2004;57:114-8. [PMID: 15284560]
Perno JFSchunk JEHansen KWFurnival RA. Significant reduction in delayed diagnosis of injury with implementation of a pediatric trauma service. Pediatr Emerg Care. 2005;21:367-71. [PMID: 15942513]
Ursprung RGray JEEdwards WHHorbar JDNickerson JPlsek Pet al. Real time patient safety audits: improving safety every day. Qual Saf Health Care. 2005;14:284-9. [PMID: 16076794]
Raab SSAndrew-Jaja CCondel JLDabbs DJ. Improving Papanicolaou test quality and reducing medical errors by using Toyota production system methods. Am J Obstet Gynecol. 2006;194:57-64. [PMID: 16389010]
Raab SSGrzybicki DMSudilovsky DBalassanian RJanosky JEVrbin CM. Effectiveness of Toyota process redesign in reducing thyroid gland fine-needle aspiration error. Am J Clin Pathol. 2006;126:585-92. [PMID: 16938657]
Raab SSTworek JASouers RZarbo RJ. The value of monitoring frozen section-permanent section correlation data over time. Arch Pathol Lab Med. 2006;130:337-42. [PMID: 16519561]
Raab SSJones BASouers RTworek JA. The effect of continuous monitoring of cytologic-histologic correlation data on cervical cancer screening performance. Arch Pathol Lab Med. 2008;132:16-22. [PMID: 18181668]
Mueller CAKlaassen-Mielke RPenner EJunius-Walker UHummers-Pradier ETheile G. Disclosure of new health problems and intervention planning using a geriatric assessment in a primary care setting. Croat Med J. 2010;51:493-500. [PMID: 21162161]
de Vries ENEikens-Jansen MPHamersma AMSmorenburg SMGouma DJBoermeester MA. Prevention of surgical malpractice claims by use of a surgical safety checklist. Ann Surg. 2011;253:624-8. [PMID: 21209590]
Ross PDHuang CKarpf DLydick ECoel MHirsch Let al. Blinded reading of radiographs increases the frequency of errors in vertebral fracture detection. J Bone Miner Res. 1996;11:1793-800. [PMID: 8915788]
Goodyear NUlness BKPrentice JLCookson BTLimaye AP. Systematic assessment of culture review as a tool to assess errors in the clinical microbiology laboratory. Arch Pathol Lab Med. 2008;132:1792-5. [PMID: 18976017]
Lewis GSharp DBartholomew JPelosi AJ. Computerized assessment of common mental disorders in primary care: effect on clinical outcome. Fam Pract. 1996;13:120-6. [PMID: 8732321]
Meier FAVarney RCZarbo RJ. Study of amended reports to evaluate and improve surgical pathology processes. Adv Anat Pathol. 2011;18:406-13. [PMID: 21841408]
Wexler JRSwender PTTunnessen WW JrOski FA. Impact of a system of computer-assisted diagnosis. Initial evaluation of the hospitalized patient. Am J Dis Child. 1975;129:203-5. [PMID: 1091140]
Wellwood JJohannessen SSpiegelhalter DJ. How does computer-aided diagnosis improve the management of acute abdominal pain? Ann R Coll Surg Engl. 1992;74:40-6. [PMID: 1736794]
Poon EGKuperman GJFiskio JBates DW. Real-time notification of laboratory data requested by users through alphanumeric pagers. J Am Med Inform Assoc. 2002;9:217-22. [PMID: 11971882]
Gur DSumkin JHRockette HEGanott MHakim CHardesty Let al. Changes in breast cancer detection and mammography recall rates after the introduction of a computer-aided detection system. J Natl Cancer Inst. 2004;96:185-90. [PMID: 14759985]
Cupples TECunningham JEReynolds JC. Impact of computer-aided detection in a regional screening mammography program. AJR Am J Roentgenol. 2005;185:944-50. [PMID: 16177413]
Fenton JJTaplin SHCarney PAAbraham LSickles EAD'Orsi Cet al. Influence of computer-aided detection on performance of screening mammography. N Engl J Med. 2007;356:1399-409. [PMID: 17409321]
Park HIMin WKLee WPark HPark CJChi HSet al. Evaluating the short message service alerting system for critical value notification via PDA telephones. Ann Clin Lab Sci. 2008;38:149-56. [PMID: 18469361]
Piva ESciacovelli LZaninotto MLaposata MPlebani M. Evaluation of effectiveness of a computerized notification system for reporting critical values. Am J Clin Pathol. 2009;131:432-41. [PMID: 19228648]
Singh HWilson LPetersen LASawhney MKReis BEspadas Det al. Improving follow-up of abnormal cancer screens using electronic health records: trust but verify test result communication. BMC Med Inform Decis Mak. 2009;9:49. [PMID: 20003236]
David CVChira SEells SJLadrigan MPapier AMiller LGet al. Diagnostic accuracy in patients admitted to hospitals with cellulitis. Dermatol Online J. 2011;17:1. [PMID: 21426867]
Jiang YNishikawa RMSchmidt RAToledano AYDoi K. Potential of computer-aided diagnosis to reduce variability in radiologists' interpretations of mammograms depicting microcalcifications. Radiology. 2001;220:787-94. [PMID: 11526283]
Leaper DJHorrocks JCStaniland JRDe Dombal FT. Computer-assisted diagnosis of abdominal pain using “estimates” provided by clinicians. Br Med J. 1972;4:350-4. [PMID: 4629240]
Nishikawa RMSchmidt RALinver MNEdwards AVPapaioannou JStull MA. Clinically missed cancer: how effectively can radiologists use computer-aided detection? AJR Am J Roentgenol. 2012;198:708-16. [PMID: 22358014]
Ciatto SDel Turco MRMorrone DCatarzi SAmbrogetti DCariddi Aet al. Independent double reading of screening mammograms. J Med Screen. 1995;2:99-101. [PMID: 7497164]
Howard JSundararajan RThomas SGWalsh MSundararajan M. Reducing missed injuries at a level II trauma center. J Trauma Nurs. 2006;13:89-95. [PMID: 17052086]
Singh PWarnakulasuriya S. The two-week wait cancer initiative on oral cancer; the predictive value of urgent referrals to an oral medicine unit. Br Dent J. 2006;201:717-20. [PMID: 17159958]
Bruner JMInouye LFuller GNLangford LA. Diagnostic discrepancies and their clinical impact in a neuropathology referral practice. Cancer. 1997;79:796-803. [PMID: 9024718]
Carew-McColl M. Radiological interpretation in an accident and emergency department. Br J Clin Pract. 1983;37:375-7. [PMID: 6671078]
Galasko CSMonahan PR. Value of re-examining x-ray films of outpatients attending accident services. Br Med J. 1971;1:643-4. [PMID: 5548841]
Lind ACBewtra CHealy JCSims KL. Prospective peer review in surgical pathology. Am J Clin Pathol. 1995;104:560-6. [PMID: 7572817]
Lufkin KCSmith SWMatticks CABrunette DD. Radiologists' review of radiographs interpreted confidently by emergency physicians infrequently leads to changes in patient management. Ann Emerg Med. 1998;31:202-7. [PMID: 9472181]
Murphy RSlater AUberoi RBungay HFerrett C. Reduction of perception error by double reporting of minimal preparation CT colon. Br J Radiol. 2010;83:331-5. [PMID: 19651707]
Parameswaran LPrihoda TJSharkey FE. Diagnostic efficacy of additional step-sections in colorectal biopsies originally diagnosed as normal. Hum Pathol. 2008;39:579-83. [PMID: 18289637]
Robson Nvan Benthem PPGan RDixon AK. Casualty X-ray reporting: a student survey. Clin Radiol. 1985;36:479-81. [PMID: 4075715]
Thiesse POllivier LDi Stefano-Louineau DNégrier SSavary JPignard Ket al. Response rate accuracy in oncology trials: reasons for interobserver variability. Groupe Français d'Immunotherapie of the Fédération Nationale des Centres de Lutte Contre le Cancer. J Clin Oncol. 1997;15:3507-14. [PMID: 9396404]
Westra WHKronz JDEisele DW. The impact of second opinion surgical pathology on the practice of head and neck surgery: a decade experience at a large referral hospital. Head Neck. 2002;24:684-93. [PMID: 12112543]
Buchner AMShahid MWHeckman MGDiehl NNMcNeil RBCleveland Pet al. Trainee participation is associated with increased small adenoma detection. Gastrointest Endosc. 2011;73:1223-31. [PMID: 21481861]
Swanson JOThapa MMIyer RSOtto RKWeinberger E. Optimizing peer review: a year of experience after instituting a real-time comment-enhanced program at a children's hospital. AJR Am J Roentgenol. 2012;198:1121-5. [PMID: 22528902]
Thomas DCSpitzer WOMacFarlane JK. Inter-observer error among surgeons and nurses in presymptomatic detection of breast disease. J Chronic Dis. 1981;34:617-26. [PMID: 7309826]
Davis Giardina TSingh H. Should patients get direct access to their laboratory test results? An answer with many questions. JAMA. 2011;306:2502-3. [PMID: 22122864]
Casalino LPDunham DChin MHBielang RKistner EOKarrison TGet al. Frequency of failure to inform patients of clinically significant outpatient test results. Arch Intern Med. 2009;169:1123-9. [PMID: 19546413]
Callen JLWestbrook JIGeorgiou ALi J. Failure to follow-up test results for ambulatory patients: a systematic review. J Gen Intern Med. 2012;27:1334-48. [PMID: 22183961]


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Elisa Piva, MD, Mario Plevani, MD29 July 2013
The paper by Kathryn M McDonald et al. deals with the topic of patient safety strategies which aim to reduce diagnostic errors. Given the complexity of the issue and the nature of diagnostic errors, the key point that “approaches to reduce errors may involve technical, cognitive, and system-oriented strategies tailored to specific conditions or settings” (1) represents a crucial strategy with which we are complete agreement. Focusing on technology-based systems interventions, a body of evidence has been collected to demonstrate the importance of timely and safe notification of laboratory critical values to clinicians. The Joint Commission (2) and many accreditation agencies (3) agree that critical value reporting is an important mission of clinical laboratory. More recently, the possible harmonization of existing policies, based on robust evidence, has been advocated for improving quality and patient safety (4). However, there are few reports on the relationship between the notification of critical values, clinicians’ reaction and improved clinical outcomes. We recently performed a clinical audit aimed at evaluating the effectiveness of a computerized notification system in reporting critical values within our University-Hospital as previously described (5). In particular, we evaluated over 200 critical values over a three-month period for inpatients, of which 75% were from Internal Medicine Departments and 25% from Surgical Departments. In both settings, 43% of the critical values were unexpected by clinicians and the therapy was modified in 90% of the patients admitted to the Internal Medicine wards, and in 96% of the patients in the Surgery department, respectively. Our data underline the importance of timely and safe notification of critical values to clinical outcomes, namely immediate changes in therapy or patient management and as a quality indicator in laboratory medicine. Therefore, timeliness of laboratory results, especially for critical values and critical tests, should always be correlated with clinical effectiveness, and procedures should provide the best clinical outcomes at the lowest reasonable cost. Further initiatives to promote the harmonization of laboratory practices, including the reporting of critical values, should help to further improve the quality of care and patient safety.Elisa Piva and Mario PlebaniDepartment of Laboratory Medicine, University-Hospital, Padova, ItalyReferences1. McDonald KM, Matesic B, Contopoulos-Ioannidis DG, Lonhart J, Schmidt E, PinedaN, Ioannidis JP. Patient safety strategies targeted at diagnostic errors: a systematic review. Ann Intern Med. 2013 ;158:381-9. 2. Singh H, Vij MS. Eight recommendations for policies for communicating abnormal test results. Jt Comm J Qual Patient Saf. 2010; 36:226-32.3. International Organization for Standardization. ISO 15189:2012: Medical laboratories: particular requirements for quality and competence. Geneva, Switzerland: International Organization for Standardization; 2012.4. Plebani M. Harmonization in laboratory medicine: the complete picture. Clin Chem Lab Med. 2013; 51:741-51.5. Piva E, Sciacovelli L, Zaninotto M, Laposata M, Plebani M. Evaluation of effectiveness of a computerized notification system for reporting critical values. Am J Clin Pathol. 2009;131:43

Information & Authors


Published In

cover image Annals of Internal Medicine
Annals of Internal Medicine
Volume 158Number 5_Part_25 March 2013
Pages: 381 - 389


Published online: 5 March 2013
Published in issue: 5 March 2013




Kathryn M. McDonald, MM
From Stanford Center for Health Policy/Center for Primary Care and Outcomes Research; Stanford University School of Medicine; Stanford Prevention Research Center; School of Humanities and Sciences, Stanford University, Stanford, California; and Palo Alto Medical Foundation Research Institute, Palo Alto, California.
Brian Matesic, BS
From Stanford Center for Health Policy/Center for Primary Care and Outcomes Research; Stanford University School of Medicine; Stanford Prevention Research Center; School of Humanities and Sciences, Stanford University, Stanford, California; and Palo Alto Medical Foundation Research Institute, Palo Alto, California.
Despina G. Contopoulos-Ioannidis, MD
From Stanford Center for Health Policy/Center for Primary Care and Outcomes Research; Stanford University School of Medicine; Stanford Prevention Research Center; School of Humanities and Sciences, Stanford University, Stanford, California; and Palo Alto Medical Foundation Research Institute, Palo Alto, California.
Julia Lonhart, BS, BA
From Stanford Center for Health Policy/Center for Primary Care and Outcomes Research; Stanford University School of Medicine; Stanford Prevention Research Center; School of Humanities and Sciences, Stanford University, Stanford, California; and Palo Alto Medical Foundation Research Institute, Palo Alto, California.
Eric Schmidt, BA
From Stanford Center for Health Policy/Center for Primary Care and Outcomes Research; Stanford University School of Medicine; Stanford Prevention Research Center; School of Humanities and Sciences, Stanford University, Stanford, California; and Palo Alto Medical Foundation Research Institute, Palo Alto, California.
Noelle Pineda, BA
From Stanford Center for Health Policy/Center for Primary Care and Outcomes Research; Stanford University School of Medicine; Stanford Prevention Research Center; School of Humanities and Sciences, Stanford University, Stanford, California; and Palo Alto Medical Foundation Research Institute, Palo Alto, California.
John P.A. Ioannidis, MD, DSc
From Stanford Center for Health Policy/Center for Primary Care and Outcomes Research; Stanford University School of Medicine; Stanford Prevention Research Center; School of Humanities and Sciences, Stanford University, Stanford, California; and Palo Alto Medical Foundation Research Institute, Palo Alto, California.
Note: The AHRQ reviewed contract deliverables to ensure adherence to contract requirements and quality, and a copyright release was obtained from the AHRQ before the manuscript was submitted for publication.
Disclaimer: All statements expressed in this work are those of the authors and should not in any way be construed as official opinions or positions of Stanford University, the AHRQ, or the U.S. Department of Health and Human Services.
Financial Support: From the AHRQ, U.S. Department of Health and Human Services (contract HHSA-290-2007-100621).
Disclosures: Ms. McDonald: Grant (money to institution): AHRQ. Mr. Schmidt: Grant (money to institution): AHRQ. All other authors had no disclosures to report. Disclosures can also be viewed at
Corresponding Author: Kathryn M. McDonald, MM, Stanford University, 117 Encina Commons, Stanford, CA 94305-6019; e-mail, [email protected].
Current Author Addresses: Ms. McDonald, Ms. Lonhart, and Mr. Schmidt: Stanford Center for Health Policy/Center for Primary Care and Outcomes Research, Stanford University, 117 Encina Commons, Stanford, CA 94305-6019.
Mr. Matesic and Ms. Pineda: School of Medicine, Stanford University, 291 Campus Drive, Stanford, CA 94305.
Dr. Contopoulos-Ioannidis: Department of Pediatrics, Division of Infectious Diseases, Stanford University School of Medicine, 300 Pasteur Drive, G312, Stanford, CA 94305.
Dr. Ioannidis: Stanford Prevention Research Center, Department of Medicine, School of Medicine, Stanford University, 1265 Welch Road, X306, Stanford, CA 94305.
Author Contributions: Conception and design: K.M. McDonald, B. Matesic, D.G. Contopoulos-Ioannidis, J. Lonhart, J.P.A. Ioannidis.
Analysis and interpretation of the data: K.M. McDonald, B. Matesic, D.G. Contopoulos-Ioannidis, J. Lonhart, E. Schmidt, J.P.A. Ioannidis.
Drafting of the article: K.M. McDonald, B. Matesic, D.G. Contopoulos-Ioannidis, J. Lonhart, E. Schmidt, J.P.A. Ioannidis.
Critical revision of the article for important intellectual content: K.M. McDonald, B. Matesic, D.G. Contopoulos-Ioannidis, J.P.A. Ioannidis.
Final approval of the article: K.M. McDonald, B. Matesic, D.G. Contopoulos-Ioannidis, J. Lonhart, E. Schmidt, N. Pineda, J.P.A. Ioannidis.
Provision of study materials or patients: J. Lonhart.
Statistical expertise: D.G. Contopoulos-Ioannidis, J.P.A. Ioannidis.
Obtaining of funding: K.M. McDonald.
Administrative, technical, or logistic support: K.M. McDonald, B. Matesic, J. Lonhart, E. Schmidt, N. Pineda.
Collection and assembly of data: K.M. McDonald, B. Matesic, J. Lonhart, E. Schmidt, N. Pineda, J.P.A. Ioannidis.

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Kathryn M. McDonald, Brian Matesic, Despina G. Contopoulos-Ioannidis, et al. Patient Safety Strategies Targeted at Diagnostic Errors: A Systematic Review. Ann Intern Med.2013;158:381-389. [Epub 5 March 2013]. doi:10.7326/0003-4819-158-5-201303051-00004

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