Background: Patients' involvement in patient safety has increased in healthcare. Use of checklists may improve patient outcome in surgery, though few have attempted to engage patients' use of surgical checklist. To identify risk elements of complications based on patients' and healthcare workers' experiences is warranted. This study aims to identify what the patients and healthcare workers find to be the risk elements that should be included in a patient-driven surgical patient safety checklist. Method: A qualitative study design where post-operative patients, surgeons, ward physicians, ward nurses, and secretaries from five surgical specialties took part in focus group interviews. Eleven focus groups were conducted including 25 post-operative patients and 27 healthcare workers at one tertiary teaching hospital and one community hospital in Norway. Based on their experiences, participants were asked to identify perceived risks before and after surgery. The interviews were analysed using content analysis.Results: Safety risk factors were categorised as pre-operative information: pre-operative preparations, post-operative information, post-operative plans and follow-up. The subcategories under pre-operative information and preparations were: contact information, medication safety, health status, optimising health, dental status, read information, preparation two weeks before surgery, inform your surgical ward, planning your own discharge, preparation on admission and just before surgery. The subcategories under post-operative information, further plans and follow-up were: prevention and complications, restriction and activity, medication safety, pain relief, stomach functions, further care and appointments. Both healthcare workers and patients express the need for a surgical patient safety checklist. Conclusion:A broad spectre of risk elements for a patient safety checklist were identified. Developing a surgical safety checklist based on these risk elements might reduce complications and unwanted errors. Trail registration: The study is registered as part of a clinical trial in ClinicalTrials.gov: NCT03105713.
Background Poor uptake and understanding of critical perioperative information represent a major safety risk for surgical patients. Implementing a patient-driven surgical safety checklist might enhance the way critical information is given and increase patient involvement in their own safety throughout the surgical pathway. The aim of this study was to develop and validate a Surgical Patient Safety Checklist (PASC) for use by surgical patients. Method This was a prospective study, involving patient representatives, multidisciplinary healthcare professionals and elective surgical patients to develop and validate PASC using consensus-building techniques in two Norwegian hospitals. A set of items intended for PASC were rated by patients and then submitted to Content Validation Index (CVI) analyses. Items of low CVI went through a Healthcare Failure Mode and Effect Analysis (HFMEA) Hazard Scoring process, as well as a consensus process before they were either kept or discarded. Reliability of patients’ PASC ratings was assessed using Intraclass Correlation Coefficient analysis. Lastly, the face validity of PASC was investigated through focus group interviews with postoperative patients. Results Initial development of PASC resulted in a checklist consisting of two parts, one before (32 items) and one after surgery (26 items). After achieving consensus on the PASC content, 215 surgical patients from six surgical wards rated the items for the CVI analysis on a 1-4 scale and mostly agreed on the content. Five items were removed from the checklist, and six items were redesigned to improve PASCs’ user-friendliness. The total Scale-level index/Average (S-CVI/Ave) before revision was 0.83 and 0.86 for pre- and post-operative PASC items, respectively. Following revision, these increased to 0.86 and 0.93, respectively. The PASC items reliability score was 0.97 (95% confidence interval 0.96 to 0.98). The qualitative assessment identified that patients who used PASC felt more in control of their situation; this was achieved when PASC was given to them at what they felt was the right time and healthcare professionals took part in its usage. Conclusion Multidisciplinary perioperative care staff and surgical patients agreed upon PASC content, the checklist ratings were reliable, and qualitative assessment suggested good face validity. PASC appears to be a usable and valid checklist for elective surgical patients across specialties.
Background The World Health Organization’s Global Patient Safety Action Plan 2021–2030 call for attention to patient and family involvement to reduce preventable patient harm. Existing evidence indicates that patients’ involvement in their own safety has positive effects on reducing hospitalisation time and readmissions. One intervention reported in the literature is the use of checklists designed for patients’ completion. Studies on such checklists are small scale, but they are linked to reduction in length of hospital stay and readmissions. We have previously developed and validated a two-part surgical patient safety checklist (PASC). This study aims to investigate the feasibility of the PASC usage and implementation prior to its use in a large-scale clinical trial. Methods This is a prospective cross-sectional feasibility study, set up as part of the design of a larger stepped-wedge cluster randomised controlled trial (SW-CRCT). Descriptive statistics were used to investigate patient demographics, reasons for not completing the PASC and percentage of PASC item usage. Qualitative patient interviews were used to identify barriers and drivers for implementation. Interview was analysed through content analysis. Results Out of 428 recruited patients, 50.2% (215/428) used both parts of PASC. A total of 24.1% (103/428) of the patients did not use it at all due to surgical or COVID-19-related cancellations. A total of 19.9% (85/428) did not consent to participate, 5.1% (22/428) lost the checklist and 0.7% (3/428) of the patients died during the study. A total of 86.5% (186/215) patients used ≥ 80% of the checklist items. Barriers and drivers for PASC implementation were grouped into the following categories: Time frame for completing the checklist, patient safety checklist design, impetus to communicate with healthcare professionals and support throughout the surgical pathway. Conclusions Elective surgical patients were willing and able to use PASC. The study further revealed a set of barriers and drivers to the implementation. A large-scale definitive clinical-implementation hybrid trial is being launched to ascertain the clinical effectiveness and scalability of PASC in improving surgical patient safety. Trial registration Clinicaltrials.gov: NCT03105713. Registered 10.04.2017
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