An epistemology of patient safety research: a framework for study design and interpretation. Part 2. Study design

Brown, Celia; Hofer, Timothy P.; Johal, Amanpreet; Thomson, Richard; Nicholl, J P; Franklin, Bryony Dean; Lilford, Richard

doi:10.1136/qshc.2007.023648

Cited by 125 publications

(115 citation statements)

References 41 publications

Supporting

Mentioning

106

Contrasting

Unclassified

Order By: Relevance

“…But although they are not easy to perform, n-of-1 studies can produce meaningful evidence of efficacy. Moreover, because "the problems of internal validity are soluble within the limits of probability statistics," 21 single-site studies of social programs can be internally valid, provided the study methods (for example, stepped-wedge designs 22 or time-series analyses 23 ) take into account the special properties of social programs.…”

Section: Quality Improvement As a Social And Behavioral Processmentioning

confidence: 99%

Heterogeneity Is Not Always Noise

Davidoff

2009

JAMA

104

View full text Add to dashboard Cite

Section: Quality Improvement As a Social And Behavioral Processmentioning

confidence: 99%

Heterogeneity Is Not Always Noise

Davidoff

2009

JAMA

104

View full text Add to dashboard Cite

“…However, because team members who previously used the APIC may still implicitly work according to the APIC, even while not explicitly using it, cross-contamination would improve the performance of the control group and bias the results toward an underestimation of the effects and not an overestimation. 36 The study data may be biased because the data collection took place in 7 separate OR areas. However, inductions are performed according to institutional directives valid in all operation areas; hence, the possibility that certain differences in the areas influenced the results cannot be fully excluded.…”

Section: Discussionmentioning

confidence: 99%

An Anesthesia Preinduction Checklist to Improve Information Exchange, Knowledge of Critical Information, Perception of Safety, and Possibly Perception of Teamwork in Anesthesia Teams

Tscholl

Weiss

Kolbe

et al. 2016

Survey of Anesthesiology

View full text Add to dashboard Cite

BACKGROUND: An anesthesia preinduction checklist (APIC) to be performed before anesthesia induction was introduced and evaluated with respect to 5 team-level outcomes, each being a surrogate end point for patient safety: information exchange (the percentage of checklist items exchanged by a team, out of 12 total items); knowledge of critical information (the percentage of critical information items out of 5 total items such as allergies, reported as known by the members of a team); team members' perceptions of safety (the median scores given by the members of a team on a continuous rating scale); their perception of teamwork (the median scores given by the members of a team on a continuous rating scale); and clinical performance (the percentage of completed items out of 14 required tasks, e.g., suction device checked). METHODS: A prospective interventional study comparing anesthesia teams using the APIC with a control group not using the APIC was performed using a multimethod design. Trained observers rated information exchange and clinical performance during on-site observations of anesthesia inductions. After the observations, each team member indicated the critical information items they knew and their perceptions of safety and teamwork. RESULTS: One hundred five teams using the APIC were compared with 100 teams not doing so. The medians of the team-level outcome scores in the APIC group versus the control group were as follows: information exchange: 100% vs 33% (P < 0.001), knowledge of critical information: 100% vs 90% (P < 0.001), perception of safety: 91% vs 84% (P < 0.001), perception of teamwork: 90% vs 86% (P = 0.028), and clinical performance: 93% vs 93% (P = 0.60). CONCLUSIONS: This study provides empirical evidence that the use of a preinduction checklist significantly improves information exchange, knowledge of critical information, and perception of safety in anesthesia teams-all parameters contributing to patient safety. There was a trend indicating improved perception of teamwork. The WHO Guidelines for Safe Surgery also encourage a formal inspection of the anesthetic equipment, breathing circuit, medications, and a patient's anesthetic risk before each case.The reason for introducing the separate anesthesia preinduction checklist (APIC), in addition to the already introduced WHO surgical safety checklist, was that the WHO surgical safety checklist contains only a few supercritical anesthesia items (e.g., checks of saturation sensor, but not electrocardiogram or blood pressure monitoring).In this study, we sought to evaluate whether the APIC complementing the WHO surgical safety checklist is suited to improve 5 team-level outcomes, each shown to be critical surrogate end points for patient safety: information exchange, knowledge of critical information, team members' perceptions of both safety and teamwork, and clinical performance. Figure 1 outlines the series of subitems assessed for the outcome scores: information exchange, knowledge of critical information, and clinical performance...

show abstract

“…To overcome these concerns, a type of cluster RCT, the stepped wedge design, has gained attention [61][62][63][64][65][66][67]. A randomized stepped wedge design involves the randomized sequential roll-out of an intervention to study units at different time points until all units have received the intervention [59,68,69]. No study included in this review employed a cluster RCT methodology.…”

Section: Study Design Study Design and Hierarchy Of Evidencementioning

confidence: 99%