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Table 3 Methods and instruments for measuring the effects of a multifaceted implementation strategy to implement the Dutch national perioperative safety guidelines

From: Improving the implementation of perioperative safety guidelines using a multifaceted intervention approach: protocol of the IMPROVE study, a stepped wedge cluster randomized trial

Outcome variable Data source (type of measurement) Frequency of measurement and sample size per measurement Moment of measurement Unit of analysis
Primary outcome (guideline adherence measured by an indicator set of nine process and structure indicators)     
Completion of the total STOP bundle (seven separate stop moments in the perioperative care process), % patients Retrospective patient record review in the hospital information systems 4 (T0 (before), T1, T2, T3 (after) measurement) N = 1,800 −3 months, +4 months, +11 months and +18 months Patient
Availability of a protocol on antibiotic use Short questionnaire on the underlying items of the structure indicators 4 (T0 (before), T1, T2, T3 (after) measurement) N = 1 −3 months, +4 months, +11 months and +18 months Hospital
Timely administration of antibiotic prophylaxis, % patients Retrospective patient record review in the hospital information systems 4 (T0 (before), T1, T2, T3 (after) measurement) N = 1,800 −3 months, +4 months, +11 months and +18 months Patient
Availability of a protocol on anticoagulant use Short questionnaire on the underlying items of the structure indicators 4 (T0 (before), T1, T2, T3 (after) measurement) N = 1 −3 months, +4 months, +11 months and +18 months Hospital
Availability of a protocol on responsibilities regarding maintenance of medical equipment Short questionnaire on the underlying items of the structure indicators 4 (T0 (before), T1, T2, T3 (after) measurement) N = 1 −3 months, +4 months, +11 months and +18 months Hospital
Availability of a protocol on (performing) prospective risk analysis of medical equipment Short questionnaire on the underlying items of the structure indicators 4 (T0 (before), T1, T2, T3 (after) measurement) N = 1 −3 months, +4 months, +11 months and +18 months Hospital
Availability of OR regulations Short questionnaire on the underlying items of the structure indicators 4 (T0 (before), T1, T2, T3 (after) measurement) N = 1 −3 months, +4 months, +11 months and +18 months Hospital
Presence of a surveillance system for postoperative wound infections Short questionnaire on the underlying items of the structure indicators 4 (T0 (before), T1, T2, T3 (after) measurement) N = 1 −3 months, +4 months, +11 months and +18 months Hospital
Presence of a morbidity and mortality registration Short questionnaire on the underlying items of the structure indicators 4 (T0 (before), T1, T2, T3 (after) measurement) N = 1 −3 months, +4 months, +11 months and +18 months Hospital
Secondary outcomes     
Complications (in-hospital), % patients Retrospective patient record review in the hospital information systems 4 (T0 (before), T1, T2, T3 (after) measurement) N = 1,800 −3 months, +4 months, +11 months and +18 months Patient
Postoperative wound infections (in-hospital), % patients Retrospective patient record review in the hospital information systems 4 (T0 (before), T1, T2, T3 (after) measurement) N = 1,800 −3 months, +4 months, +11 months and +18 months Patient
Postoperative mortality (in-hospital), % patients Retrospective patient record review in the hospital information systems 4 (T0 (before), T1, T2, T3 (after) measurement) N = 1,800 −3 months, +4 months, +11 months and +18 months Patient
Length of hospital stay, number of days Retrospective patient record review in the hospital information systems 4 (T0 (before), T1, T2, T3 (after) measurement) N = 1,800 −3 months, +4 months, +11 months and +18 months Patient
Unscheduled transfer to the ICU (within 30 days after the initial surgery), % patients Retrospective patient record review in the hospital information systems 4 (T0 (before), T1, T2, T3 (after) measurement) N = 1,800 −3 months, +4 months, +11 months and +18 months Patient
Non-elective hospital readmission (within 30 days after the initial surgery), % patients Retrospective patient record review in the hospital information systems 4 (T0 (before), T1, T2, T3 (after) measurement) N = 1,800 −3 months, +4 months, +11 months and +18 months Patient
Unscheduled reoperation (within 30 days after the initial surgery), % patients Retrospective patient record review in the hospital information systems 4 (T0 (before), T1, T2, T3 (after) measurement) N = 1,800 −3 months, +4 months, +11 months and +18 months Patient
Determinants of change     
Team climate Team climate inventory 1 (T0 (before) measurement) −3 months Professional
Patients safety culture Hospital survey on patient safety culture 1 (T0 (before) measurement) −3 months Professional
Barriers and facilitators of guideline adherence Questionnaire 1 (before the start of the implantation period in the concerning group of hospitals) N ≥ 7 (at least one surgeon, anesthesiologist, OR, anesthesia, recovery, and ward nurse, and ICU employee) Variable (depending on the start of the implementation period) Professional