Project description:BackgroundPoor 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.MethodThis 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.ResultsInitial 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.ConclusionMultidisciplinary 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.
Project description:The re-establishment of conscious awareness after discontinuing general anesthesia has often been assumed to be the inverse of loss of consciousness. This is despite the obvious asymmetry in the initiation and termination of natural sleep. In order to characterize the restoration of consciousness after surgery, we recorded frontal electroencephalograph (EEG) from 100 patients in the operating room during maintenance and emergence from general anesthesia. We have defined, for the first time, 4 steady-state patterns of anesthetic maintenance based on the relative EEG power in the slow-wave (<14 Hz) frequency bands that dominate sleep and anesthesia. Unlike single-drug experiments performed in healthy volunteers, we found that surgical patients exhibited greater electroencephalographic heterogeneity while re-establishing conscious awareness after drug discontinuation. Moreover, these emergence patterns could be broadly grouped according to the duration and rapidity of transitions amongst these slow-wave dominated brain states that precede awakening. Most patients progressed gradually from a pattern characterized by strong peaks of delta (0.5-4 Hz) and alpha/spindle (8-14 Hz) power ('Slow-Wave Anesthesia') to a state marked by low delta-spindle power ('Non Slow-Wave Anesthesia') before awakening. However, 31% of patients transitioned abruptly from Slow-Wave Anesthesia to waking; they were also more likely to express pain in the post-operative period. Our results, based on sleep-staging classification, provide the first systematized nomenclature for tracking brain states under general anesthesia from maintenance to emergence, and suggest that these transitions may correlate with post-operative outcomes such as pain.
Project description:ImportanceModification of the World Health Organization's Surgical Safety Checklist (SSC) is a critical component of its implementation. To facilitate the SSC's use, it is important to know how surgical teams modify their SSCs, their reasons for making modifications, and the opportunities and challenges teams face in SSC tailoring.ObjectiveTo study SSC modifications in high-income hospital settings in 5 countries: Australia, Canada, New Zealand, the United States, and the United Kingdom.Design, setting, and participantsThis qualitative study used semistructured interviews based on the survey used in the quantitative study. Each interviewee was asked a core set of questions and various follow-up questions based on their survey responses. Interviews were conducted from July 2019 to February 2020 in person and online using teleconferencing software. Surgeons, anesthesiologists, nurses, and hospital administrators from the 5 countries were recruited through a survey and snowball sampling.Main outcomes and measuresInterviewees' attitudes and perceptions on SSC modifications and their perceived impact on operating rooms.ResultsA total of 51 surgical team members and hospital administrators from the 5 countries were interviewed (37 [75%] with >10 years of service; 28 [55%] women). There were 15 (29%) surgeons, 13 (26%) nurses, 15 (29%) anesthesiologists, and 8 (16%) health administrators. Five themes emerged concerning the awareness and involvement in SSC modifications; reasons for modifications; types of modifications; the outcomes of modifications; and perceived barriers to SSC modifications. Based on the interviews, some SSCs may go many years without being revisited or modified. SSCs are modified to ensure they address local issues and standards of practice and that they are fit for purpose. Modifications are also made following adverse events to reduce the risk of reoccurrence. Interviewees described adding, moving, and removing elements from their SSCs, which increased their sense of ownership in their SSC and participation in its performance. Some barriers to modification included leadership and the SSC's inclusion in hospitals' electronic medical record.Conclusions and relevanceIn this qualitative study of surgical team members and administrators, interviewees described addressing contemporary surgical issues through various SSC modifications. The process of SSC modification may improve team cohesion and buy-in in addition to providing opportunities for teams to improve patient safety.
Project description:BackgroundThe WHO Surgical Safety Checklist has a growing evidence base to support its role in improving perioperative safety, although its impact is likely to be directly related to the effectiveness of its implementation. There remains a paucity of documented experience from low-resource settings on Checklist implementation approaches. We report an implementation strategy in a public referral hospital in Addis Ababa, Ethiopia, based on consultation, local leadership, formal introduction, and supported supervision with subsequent audit and feedback.MethodsPlanning, implementation and assessment took place from December 2011 to December 2012. The planning phase, from December 2011 until April 2012, involved a multidisciplinary consultative approach using local leaders, volunteer clinicians, and staff from non-governmental organisations, to draw up a locally agreed and appropriate Checklist. Implementation in April 2012 involved formal teaching and discussion, simulation sessions and role play, with supportive supervision following implementation. Assessment was performed using completed Checklist analysis and staff satisfaction questionnaires at one month and further Checklist analysis combined with semi-structured interviews in December 2012.Results and discussionChecklist compliance rates were 83% for general anaesthetics at one month after implementation, with an overall compliance rate of 65% at eight months. There was a decrease in Checklist compliance over the period of the study to less than 20% by the end of the study period. The 'Sign out' section was reported as being the most difficult section of the Checklist to complete, and was missed completely in 21% of cases. The most commonly missed single item was the team introduction at the start of each case. However, we report high staff satisfaction with the Checklist and enthusiasm for its continued use.ConclusionWe report a detailed implementation strategy for introducing the WHO Surgical Safety Checklist to a low-resource setting. We show that this approach can lead to high completion rates and high staff satisfaction, albeit with a drop in completion rates over time. We argue that maximal benefit of the Surgical Safety Checklist is likely to be when it engenders a conversation around patient safety within a department, and when there is local ownership of this process.
Project description:BackgroundCharting is an essential component of professional nursing practice and is arguably a key element of patient safety in surgery: without proper, objective, and timely documentation, both benign and tragical errors can occur. From surgery on wrong patients to wrong limbs, to the omission of antibiotics administration, many harms can happen in the operating room. Documentation has thus served as a safeguard for patient safety, professional responsibility, and professional accountability. In this context, we were puzzled by the practices we observed with respect to charting compliance with the surgical safety checklist (SSC) during a study of surgical teams in a large, urban teaching hospital in Canada (pseudonym 'C&C').MethodsThis article leverages institutional ethnography and a subset of data from a larger study to describe and explain the social organisation of the system that monitored surgical safety compliance at C&C from the standpoint of operating room nurses. This data included fieldnotes from observations of 51 surgical cases, on-the-spot interviews with nurses, formal interviews with individuals who were involved in the design and implementation of the SSC, and open-ended questions from two rounds of survey of OR teams.FindingsWe found that the compliance form and not the SSC itself formed the basis for reporting. To meet hospital accuracy in charting goals and legislated compliance documentation reporting requirements nurses 'pre-charted' compliance with the surgical checklist. The adoption of this workaround technically violated nursing charting principles and put them in ethically untenable positions.ConclusionsDocumenting compliance of the SSC constituted a moral hazard, constrained nurses' autonomy and moral agency, and obscured poor checklist adherence. The findings highlight how local and extra local texts, technologies and relations create ethical issues, raise questions about the effectiveness of resulting data for decision-making and contribute to ongoing conversations about nursing workarounds.
Project description:BackgroundThe WHO Surgical Safety Checklist improves surgical outcomes, but evidence and theoretical frameworks for successful implementation in low-income countries remain lacking. Based on previous research in Madagascar, a nationwide checklist implementation in Benin was designed and evaluated longitudinally.MethodsThis study had a longitudinal embedded mixed-methods design. The well validated Consolidated Framework for Implementation Research (CFIR) was used to structure the approach and evaluate the implementation. Thirty-six hospitals received 3-day multidisciplinary training and 4-month follow-up. Seventeen hospitals were sampled purposively for evaluation at 12-18 months. The primary outcome was sustainability of checklist use at 12-18 months measured by questionnaire. Secondary outcomes were CFIR-derived implementation outcomes, measured using the WHO Behaviourally Anchored Rating Scale (WHOBARS), safety questionnaires and focus groups.ResultsAt 12-18 months, 86·0 per cent of participants (86 of 100) reported checklist use compared with 31·1 per cent (169 of 543) before training and 88·8 per cent (158 of 178) at 4 months. There was high-fidelity use (median WHOBARS score 5·0 of 7; use of basic safety processes ranged from 85·0 to 99·0 per cent), and high penetration shown by a significant improvement in hospital safety culture (adapted Human Factors Attitude Questionnaire scores of 76·7, 81·1 and 82·2 per cent before, and at 4 and 12-18 months after training respectively; P < 0·001). Acceptability, adoption, appropriateness and feasibility scored 9·6-9·8 of 10. This approach incorporated 31 of 36 CFIR implementation constructs successfully.ConclusionThis study shows successfully sustained nationwide checklist implementation using a validated implementation framework.
Project description:BackgroundThe 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.MethodsThis 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.ResultsOut 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.ConclusionsElective 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 registrationClinicaltrials.gov: NCT03105713. Registered 10.04.2017.
Project description:BackgroundThe World Health Organization (WHO) Surgical Safety Checklist has fostered safe practice for 10 years, yet its place in emergency surgery has not been assessed on a global scale. The aim of this study was to evaluate reported checklist use in emergency settings and examine the relationship with perioperative mortality in patients who had emergency laparotomy.MethodsIn two multinational cohort studies, adults undergoing emergency laparotomy were compared with those having elective gastrointestinal surgery. Relationships between reported checklist use and mortality were determined using multivariable logistic regression and bootstrapped simulation.ResultsOf 12 296 patients included from 76 countries, 4843 underwent emergency laparotomy. After adjusting for patient and disease factors, checklist use before emergency laparotomy was more common in countries with a high Human Development Index (HDI) (2455 of 2741, 89·6 per cent) compared with that in countries with a middle (753 of 1242, 60·6 per cent; odds ratio (OR) 0·17, 95 per cent c.i. 0·14 to 0·21, P < 0·001) or low (363 of 860, 42·2 per cent; OR 0·08, 0·07 to 0·10, P < 0·001) HDI. Checklist use was less common in elective surgery than for emergency laparotomy in high-HDI countries (risk difference -9·4 (95 per cent c.i. -11·9 to -6·9) per cent; P < 0·001), but the relationship was reversed in low-HDI countries (+12·1 (+7·0 to +17·3) per cent; P < 0·001). In multivariable models, checklist use was associated with a lower 30-day perioperative mortality (OR 0·60, 0·50 to 0·73; P < 0·001). The greatest absolute benefit was seen for emergency surgery in low- and middle-HDI countries.ConclusionChecklist use in emergency laparotomy was associated with a significantly lower perioperative mortality rate. Checklist use in low-HDI countries was half that in high-HDI countries.
Project description:BackgroundPatients' 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.MethodA 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.ResultsSafety 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.ConclusionA 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 registrationThe study is registered as part of a clinical trial in ClinicalTrials.gov: NCT03105713.
Project description:The 2009 World Health Organisation (WHO) surgical safety checklist significantly reduces surgical mortality and morbidity (up to 47%). Yet in 2016, only 25% of East African anesthetists regularly use the checklist. Nationwide implementation of the checklist is reported in high-income countries, but in low- and middle-income countries (LMICs) reports of successful implementations are sparse, limited to single institutions and require intensive support. Since checklist use leads to the biggest improvements in outcomes in LMICs, methods of wide-scale implementation are needed. We hypothesized that, using a three-day course, successful wide-scale implementation of the checklist could be achieved, as measured by at least 50% compliance with six basic safety processes at three to four months. We also aimed to determine predictors for checklist utilization.Using a blended educational implementation strategy based on prior pilot studies we designed a three-day dynamic educational course to facilitate widespread implementation of the WHO checklist. The course utilized lectures, film, small group breakouts, participant feedback and simulation to teach the knowledge, skills and behavior changes needed to implement the checklist. In collaboration with the Ministry of Health and local hospital leadership, the course was delivered to 427 multi-disciplinary staff at 21 hospitals located in 19 of 22 regions of Madagascar between September 2015 and March 2016. We evaluated implementation at three to four months using questionnaires (with a 5-point Likert scale) and focus groups. Multivariate linear regression was used to test predictors of checklist utilization.At three to four months, 65% of respondents reported always using the checklist, with another 13% using it in part. Participant's years in practice, hospital size, or surgical volume did not predict checklist use. Checklist use was associated with counting instruments (p< 0.05), but not with verifying: patient identity, difficult intubation risk, risk of blood loss, prophylactic antibiotic administration, or counting needles and sponges.Use of a multi-disciplinary three-day course for checklist implementation resulted in 78% of participants using the checklist, at three months; and an increase in counting surgical instruments. Successful checklist implementation was not predicted by participant length of medical service, hospital size or surgical volume. If reproducible in other countries, widespread implementation in LMICs becomes a realistic possibility.