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Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet]. York (UK): Centre for Reviews and Dissemination (UK); 1995-.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet].

Patient safety strategies targeted at diagnostic errors: a systematic review

KM McDonald, B Matesic, DG Contopoulos-Ioannidis, J Lonhart, E Schmidt, N Pineda, and JP Ioannidis.

Review published: 2013.

Link to full article: [Journal publisher]

CRD summary

The authors concluded that there was a growing amount of research on diagnostic errors, with promising interventions that should be evaluated, in large studies and various settings. The review focused on the results of randomised controlled trials and was largely well conducted. The authors' conclusion reliably reflects the limited evidence from trials, and their research recommendations seem justified.

Authors' objectives

To evaluate patient safety strategies aimed at the prevention of diagnostic errors.

Searching

MEDLINE (1996 to 2012) and the Agency for Healthcare Research and Quality (AHRQ) Patient Safety Network were searched. Search terms were reported. Bibliographies and previous systematic reviews were screened to identify further studies.

Study selection

Eligible for inclusion was any design of study that evaluated any intervention to decrease diagnostic errors, or the time to a correct diagnosis or clinical action, in any clinical setting. Studies had to measure patient-related outcomes, such as correct diagnosis – confirmed by patient follow-up tests, surgery, autopsy, or other method, or a proxy measure. Simulation studies were excluded.

The included studies evaluated medical techniques, personnel changes, educational interventions, structured process changes, technology-based systems, or (most studies) additional review methods, such as redundancy in interpreting test results. Control groups, in the included randomised controlled trials (RCTs), largely received usual care. The patient-related outcomes included diagnostic accuracy, such as false-positive and false-negative results; management outcomes, such as the use of further diagnostic tests or therapy; and (less often) direct patient-level clinical outcomes, such as death, disease progression, or deterioration. Some studies assessed composites of these outcomes. Few details were given on those delivering or receiving the intervention; some were presented in the full report (Shekelle, et al. 2013, see Other Publications of Related Interest).

Two independent reviewers selected the studies for inclusion. Discrepancies were resolved by discussion with the research team.

Assessment of study quality

The quality of the RCTs was assessed using Cochrane criteria for sequence generation, allocation concealment, blinding, completeness of outcome data, selective outcome reporting, and other sources of bias. The risk of bias was assessed as low, medium, high, or unclear. It was unclear how other study designs were assessed.

Two independent reviewers assessed study quality.

Data extraction

For RCTs, the data were extracted to present effect sizes and 95% confidence intervals. Other extracted data included the proportions and directions of effect for a variety of measures, and the diagnostic accuracy or time to diagnosis.

Two independent reviewers extracted the data.

Methods of synthesis

A narrative synthesis was conducted. The authors grouped the results according to the type of intervention.

Results of the review

One hundred and nine studies were included in the review. There were 14 RCTs. The number of participants was neither reported in the paper, nor in the full report. Nine trials had a moderate risk of bias, and five trials had a low risk of bias. The areas of high risk or uncertainty were sequence generation, allocation concealment, blinding, and selective outcome reporting.

In 11 of the 14 RCTs, statistically significant improvements were seen for at least one outcome.

Medical technique: Most of the 23 studies (including the three RCTs) showed that diagnosis could be improved (or not made worse) following interventions, such as ultrasonography-guided biopsy, changes to the number of biopsy cores, cap-fitted colonoscopy, and relief for abdominal pain.

Personnel changes: There were six studies, one of which was a RCT. The RCT favoured the performance of emergency nurse practitioners over junior physicians, in reducing unplanned follow-up visits.

Educational interventions: There were 11 studies, and two were RCTs. The RCTs showed that parent education improved their identification of serious symptoms necessitating physician intervention, and patient education improved the performance of screening for breast cancer.

Structured process changes: Of the 27 studies, three were RCTs and these provided mixed evidence on diagnosis-related outcomes, for mental illness and radiography ordering for injured patients. Two of the three trials did not demonstrate a significant effect.

Technology-based systems: There were 32 studies, and four were RCTs. All four RCTs reported beneficial effects in reducing diagnostic error following computer-based diagnosis and decision-making interventions.

Additional review methods: Of the 38 studies, one was a RCT and this trial showed a statistically significant effect following an audit and feedback approach, in cancer screening, but the evidence was weak.

There were no studies that evaluated direct patient harm, and no conclusions could be drawn on the effects of complex interventions (24 studies). The full results were reported in the paper.

Authors' conclusions

There was a growing amount of research on diagnostic errors, with promising interventions that should be evaluated, in large studies and various settings.

CRD commentary

The review question was clear. The inclusion criteria were broad, and found a wide variety of studies. Two major data sources were searched, but no sources of unpublished material were accessed, meaning that relevant studies might have been overlooked. The review process was conducted with sufficient attempts to minimise error and bias, and the quality assessment of the included trials showed that they were generally of a sufficient standard on set criteria. The study details were presented, but the participants and those delivering the intervention were not described, making the generalisability of the findings unclear. In most cases it was not possible to determine the trial sample size, which limits interpretation of their ability to detect significant effects. Clinical variation between the studies suggests that the chosen method of synthesis was appropriate.

The review focused on the results of RCTs and was largely well conducted. The authors' conclusion reliably reflects the limited evidence from trials, and their research recommendations seem justified.

Implications of the review for practice and research

Practice: The authors did not state any implications for practice, but they noted that further evidence was required before any patient safety strategy targeting diagnostic errors was scaled up.

Research: The authors stated that further research should use appropriate measurements of diagnostic errors and consequential delays in diagnosis. Evaluations of the costs of the interventions and their implementation were needed.

Funding

Funded by the Agency for Healthcare Research and Quality (AHRQ), USA.

Bibliographic details

McDonald KM, Matesic B, Contopoulos-Ioannidis DG, Lonhart J, Schmidt E, Pineda N, Ioannidis JP. Patient safety strategies targeted at diagnostic errors: a systematic review. Annals of Internal Medicine 2013; 158(5 Part 2): 381-389. [PubMed: 23460094]

Other publications of related interest

Shekelle PG, Wachter RM, Pronovost PJ, Schoelles K, McDonald KM, Dy SM, Shojania K, Reston J, Berger Z, Johnsen B, Larkin JW, Lucas S, Martinez K, Motala A, Newberry SJ, Noble M, Pfoh E, Ranji SR, Rennke S, Schmidt E, Shanman R, Sullivan N, Sun F, Tipton K, Treadwell JR, Tsou A, Vaiana ME, Weaver SJ, Wilson R, Winters BD. Making health care safer II: an updated critical analysis of the evidence for patient safety practices. Rockville, MD, USA: Agency for Healthcare Research and Quality. Comparative Effectiveness Review; 211. 2013.

Weaver SJ, Lubomski LH, Wilson RF, Pfoh ER, Martinez KA, Dy SM. Promoting a culture of safety as a patient safety strategy: a systematic review. Annals of Internal Medicine 2013; 158(5 Part 2): 369-374.

Reston JT, Schoelles KM. In-facility delirium prevention programs as a patient safety strategy: a systematic review. Annals of Internal Medicine 2013; 158(5 Part 2): 375-380.

Kwan JL, Lo L, Sampson M, Shojania KG. Medication reconciliation during transitions of care as a patient safety strategy: a systematic review. Annals of Internal Medicine 2013; 158(5 Part 2): 397-403.

Rennke S, Nguyen OK, Shoeb MH, Magan Y, Wachter RM, Ranji SR. Hospital-initiated transitional care interventions as a patient safety strategy: a systematic review. Annals of Internal Medicine 2013; 158(5 Part 2): 433-440.

Miake-Lye IM, Hempel S, Ganz DA, Shekelle PG. Inpatient fall prevention programs as a patient safety strategy: a systematic review. Annals of Internal Medicine 2013; 158(5 Part 2): 390-393.

Sullivan N, Schoelles KM. Preventing in-facility pressure ulcers as a patient safety strategy: a systematic review. Annals of Internal Medicine 2013; 158(5 Part 2): 410-416.

Shekelle PG. Nurse-patient ratios as a patient safety strategy: a systematic review. Annals of Internal Medicine 2013; 158(5 Part 2): 404-409.

Winters BD, Weaver SJ, Pfoh ER, Yang T, Pham JC, Dy SM. Rapid-response systems as a patient safety strategy: a systematic review. Annals of Internal Medicine 2013; 158(5 Part 2): 417-425.

Schmidt E, Goldhaber-Fiebert SN, Ho LA, McDonald KM. Simulation exercises as a patient safety strategy: a systematic review. Annals of Internal Medicine 2013; 158(5 Part 2): 426-432.

Indexing Status

Subject indexing assigned by NLM

MeSH

Costs and Cost Analysis; Diagnostic Errors /economics /prevention & control; Health Facility Administration /economics /standards; Humans; Organizational Objectives; Outcome Assessment (Health Care); Patient Safety /economics /standards; Randomized Controlled Trials as Topic; Safety Management /economics /methods; Text Messaging

AccessionNumber

12013013337

Database entry date

15/03/2013

Record Status

This is a critical abstract of a systematic review that meets the criteria for inclusion on DARE. Each critical abstract contains a brief summary of the review methods, results and conclusions followed by a detailed critical assessment on the reliability of the review and the conclusions drawn.

CRD has determined that this article meets the DARE scientific quality criteria for a systematic review.

Copyright © 2014 University of York.

PMID: 23460094

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