Karin Pukk Härenstam

Application of statistical process control in healthcare improvement: systematic review

Objective: To systematically review the literature regarding how statistical process control—with control charts as a core tool—has been applied to healthcare quality improvement, and to examine the benefits, limitations, barriers and facilitating factors related to such application. Data sources: Original articles found in relevant databases, including Web of Science and Medline, covering the period 1966 to June 2004. Study selection: From 311 articles, 57 empirical studies, published between 1990 and 2004, met the inclusion criteria. Methods: A standardised data abstraction form was used for extracting data relevant to the review questions, and the data were analysed thematically. Results: Statistical process control was applied in a wide range of settings and specialties, at diverse levels of organisation and directly by patients, using 97 different variables. The review revealed 12 categories of benefits, 6 categories of limitations, 10 categories of barriers, and 23 factors that facilitate its application and all are fully referenced in this report. Statistical process control helped different actors manage change and improve healthcare processes. It also enabled patients with, for example asthma or diabetes mellitus, to manage their own health, and thus has therapeutic qualities. Its power hinges on correct and smart application, which is not necessarily a trivial task. This review catalogues 11 approaches to such smart application, including risk adjustment and data stratification. Conclusion: Statistical process control is a versatile tool which can help diverse stakeholders to manage change in healthcare and improve patients’ health.

Is detection of adverse events affected by record review methodology? an evaluation of the “Harvard Medical Practice Study” method and the “Global Trigger Tool”

BackgroundThere has been a theoretical debate as to which retrospective record review method is the most valid, reliable, cost efficient and feasible for detecting adverse events. The aim of the present study was to evaluate the feasibility and capability of two common retrospective record review methods, the “Harvard Medical Practice Study” method and the “Global Trigger Tool” in detecting adverse events in adult orthopaedic inpatients.MethodsWe performed a three-stage structured retrospective record review process in a random sample of 350 orthopaedic admissions during 2009 at a Swedish university hospital. Two teams comprised each of a registered nurse and two physicians were assigned, one to each method. All records were primarily reviewed by registered nurses. Records containing a potential adverse event were forwarded to physicians for review in stage 2. Physicians made an independent review regarding, for example, healthcare causation, preventability and severity. In the third review stage all adverse events that were found with the two methods together were compared and all discrepancies after review stage 2 were analysed. Events that had not been identified by one of the methods in the first two review stages were reviewed by the respective physicians.ResultsAltogether, 160 different adverse events were identified in 105 (30.0%) of the 350 records with both methods combined. The “Harvard Medical Practice Study” method identified 155 of the 160 (96.9%, 95% CI: 92.9-99.0) adverse events in 104 (29.7%) records compared with 137 (85.6%, 95% CI: 79.2-90.7) adverse events in 98 (28.0%) records using the “Global Trigger Tool”. Adverse events “causing harm without permanent disability” accounted for most of the observed difference. The overall positive predictive value for criteria and triggers using the “Harvard Medical Practice Study” method and the “Global Trigger Tool” was 40.3% and 30.4%, respectively.ConclusionsMore adverse events were identified using the “Harvard Medical Practice Study” method than using the “Global Trigger Tool”. Differences in review methodology, perception of less severe adverse events and context knowledge may explain the observed difference between two expert review teams in the detection of adverse events.

Validation of triggers and development of a pediatric trigger tool to identify adverse events

BackgroundLittle is known about adverse events (AEs) in pediatric patients. Record review is a common methodology for identifying AEs, but in pediatrics the record review tools generally have limited focus. The aim of the present study was to develop a broadly applicable record review tool to identify AEs in pediatric inpatients.MethodsUsing a broad literature review and expert opinion with a modified Delphi process, a pediatric trigger tool with 88 triggers, definitions, and descriptions including AE preventability decision support was developed and tested in a random sample of 600 hospitalized pediatric patients admitted in 2010 to a single university children’s hospital. Four registered nurse-physician teams performed complete two-stage retrospective reviews of 150 records each from either neonatal, surgical/orthopedic, medicine, or emergency medicine units.ResultsRegistered nurse review identified 296 of 600 records with triggers indicating potential AEs. Records (n = 121) with only false positive triggers not indicating any potential AEs were not forwarded to the next review stage. On subsequent physician review, 204 (34.0%) of patients were found to have had 563 AEs, range 1–27 AEs/patient. A total of 442 preventable AEs were found in 161 patients (26.8%), range 1–22. Overall, triggers were found 3,598 times in 417 (69.5%) records, with a mean of 6 (median 1, range 0–176) triggers per patient. The overall positive predictive value of the triggers was 22.9%, (range 0.0-100.0%). The final pediatric trigger tool, developed with a second Delphi round, required 29 triggers.ConclusionsAEs are common in pediatric patients and most are preventable. The main contributions of this study are to further develop and adapt trigger definitions, including AE preventability decision support, to introduce new triggers in pediatric care, as well as to apply pediatric triggers in different clinical specialties. Our findings resulted in a national pediatric trigger tool, and might also be adapted internationally. The pediatric trigger tool can help healthcare organizations to measure and analyze the AEs occurring in hospitalized children in order to improve patient safety.

Retrospective record review in proactive patient safety work – identification of no-harm incidents

BackgroundIn contrast to other safety critical industries, well-developed systems to monitor safety within the healthcare system remain limited. Retrospective record review is one way of identifying adverse events in healthcare. In proactive patient safety work, retrospective record review could be used to identify, analyze and gain information and knowledge about no-harm incidents and deficiencies in healthcare processes. The aim of the study was to evaluate retrospective record review for the detection and characterization of no-harm incidents, and compare findings with conventional incident-reporting systems.MethodsA two-stage structured retrospective record review of no-harm incidents was performed on a random sample of 350 admissions at a Swedish orthopedic department. Results were compared with those found in one local, and four national incident-reporting systems.ResultsWe identified 118 no-harm incidents in 91 (26.0%) of the 350 records by retrospective record review. Ninety-four (79.7%) no-harm incidents were classified as preventable. The five incident-reporting systems identified 16 no-harm incidents, of which ten were also found by retrospective record review. The most common no-harm incidents were related to drug therapy (n = 66), of which 87.9% were regarded as preventable.ConclusionsNo-harm incidents are common and often preventable. Retrospective record review seems to be a valuable tool for identifying and characterizing no-harm incidents. Both harm and no-harm incidents can be identified in parallel during the same record review. By adding a retrospective record review of randomly selected records to conventional incident-reporting, health care providers can gain a clearer and broader picture of commonly occurring, no-harm incidents in order to improve patient safety.

Results from the National Perinatal Patient Safety Program in Sweden: the challenge of evaluation

We studied the effects of the national Perinatal Patient Safety Program in Sweden, addressing local improvement measures, changes in the proportion of low Apgar score and the number of settled injury claims due to asphyxia.