Effectiveness of a national quality improvement programme to improve survival after emergency abdominal surgery (EPOCH): a stepped-wedge cluster-randomised trial

Background: Emergency abdominal surgery is associated with poor patient outcomes. We studied the effectiveness of a national quality improvement (QI) programme to implement a care pathway to improve survival for these patients. Methods: We did a stepped-wedge cluster-randomised trial of patients aged 40 years or older undergoing emergency open major abdominal surgery. Eligible UK National Health Service (NHS) hospitals (those that had an emergency general surgical service, a substantial volume of emergency abdominal surgery cases, and contributed data to the National Emergency Laparotomy Audit) were organised into 15 geographical clusters and commenced the QI programme in a random order, based on a computer-generated random sequence, over an 85-week period with one geographical cluster commencing the intervention every 5 weeks from the second to the 16th time period. Patients were masked to the study group, but it was not possible to mask hospital staff or investigators. The primary outcome measure was mortality within 90 days of surgery. Analyses were done on an intention-to-treat basis. This study is registered with the ISRCTN registry, number ISRCTN80682973. Findings: Treatment took place between March 3, 2014, and Oct 19, 2015. 22 754 patients were assessed for elegibility. Of 15 873 eligible patients from 93 NHS hospitals, primary outcome data were analysed for 8482 patients in the usual care group and 7374 in the QI group. Eight patients in the usual care group and nine patients in the QI group were not included in the analysis because of missing primary outcome data. The primary outcome of 90-day mortality occurred in 1210 (16%) patients in the QI group compared with 1393 (16%) patients in the usual care group (HR 1·11, 0·96–1·28). Interpretation: No survival benefit was observed from this QI programme to implement a care pathway for patients undergoing emergency abdominal surgery. Future QI programmes should ensure that teams have both the time and resources needed to improve patient care. Funding: National Institute for Health Research Health Services and Delivery Research Programme

Effectiveness of a national quality improvement programme to improve survival after emergency abdominal surgery (EPOCH): a stepped-wedge cluster-randomised trial

BACKGROUND: Emergency abdominal surgery is associated with poor patient outcomes. We studied the effectiveness of a national quality improvement (QI) programme to implement a care pathway to improve survival for these patients. METHODS: We did a stepped-wedge cluster-randomised trial of patients aged 40 years or older undergoing emergency open major abdominal surgery. Eligible UK National Health Service (NHS) hospitals (those that had an emergency general surgical service, a substantial volume of emergency abdominal surgery cases, and contributed data to the National Emergency Laparotomy Audit) were organised into 15 geographical clusters and commenced the QI programme in a random order, based on a computer-generated random sequence, over an 85-week period with one geographical cluster commencing the intervention every 5 weeks from the second to the 16th time period. Patients were masked to the study group, but it was not possible to mask hospital staff or investigators. The primary outcome measure was mortality within 90 days of surgery. Analyses were done on an intention-to-treat basis. This study is registered with the ISRCTN registry, number ISRCTN80682973. FINDINGS: Treatment took place between March 3, 2014, and Oct 19, 2015. 22 754 patients were assessed for elegibility. Of 15 873 eligible patients from 93 NHS hospitals, primary outcome data were analysed for 8482 patients in the usual care group and 7374 in the QI group. Eight patients in the usual care group and nine patients in the QI group were not included in the analysis because of missing primary outcome data. The primary outcome of 90-day mortality occurred in 1210 (16%) patients in the QI group compared with 1393 (16%) patients in the usual care group (HR 1·11, 0·96-1·28). INTERPRETATION: No survival benefit was observed from this QI programme to implement a care pathway for patients undergoing emergency abdominal surgery. Future QI programmes should ensure that teams have both the time and resources needed to improve patient care. FUNDING: National Institute for Health Research Health Services and Delivery Research Programme

Parents’ refusal to vitamin-K supplementation among neonates and its association with vaccine refusal: A systematic review and meta-analysis

Objective: This systematic review and meta-analysis aims to estimate the prevalence of neonatal vitamin K prophylaxis refusal among parents and its possible association with subsequent vaccine hesitancy or refusal. Method: The databases searched included PubMed, Cochrane Library, Embase via Ovid, CINAHL Plus and Medline via EBSCOhost, ProQuest and PsycINFO from inception to 31 Aug 2017. Keywords, such as “vitamin K”, “refusal”, “decline”, “hesitancy”, and “vaccination” were used to identify potential studies. Analysis of proportions was conducted, while odd ratios and relative risks were estimated using the random effect model. Results: Of the 2216 studies identified, 8(0.36%) were subjected to qualitative analysis; 4(50%) retrospective cohort studies and 4(50%) cross-sectional studies. Overall, 6(75%) studies were of good quality, while 2(25%) were ranked as of fair quality. Of the 273,714 parents, 3,136(1.14%) refused to opt for the vitamin K prophylaxis. Meta-analysis concluded that refusal to vitamin K prophylaxis was significant among the included studies ((p<0.184). Conclusion: The overall risk of refusal to essential vaccination among vitamin K prophylaxis refusal group was 6.45 times compared to the group that accepted vitamin K prophylaxis. Key Words: Vaccine hesitancy, Vitamin K prophylaxis, Vaccine refusal, Newborn, Parents

General Public Views, Attitudes, and Experiences toward Drug Safety in Dubai, United Arab Emirates: A Qualitative Approach

Ensuring drug safety among the patients is the main domain of pharmacovigilance activities worldwide. A pharmacovigilance system was established in the United Arab Emirates (UAE) in 2008. Research evidence reflects that the current system is lacking in active participation from patients, and also, the inadequate role of healthcare professionals is anticipated. In this context, it is pertinent to know the general public&#8217;s understandings and their patterns of safe use of medication, which are unexplored areas in Dubai, UAE. The current study aimed to explore the public views, attitudes, and experiences toward medication safety, and to explore key factors enhancing the safe use of medications among the public in Dubai. This study adopted a qualitative approach and face-to-face, 14 in-depth interviews with public individuals, selected purposively using the snowball sampling technique. The interviews were conducted in different places in Dubai recorded and transcribed verbatim and thematically analyzed for data analysis. Reporting of adverse drug reaction was not well-known among all the participants. Public views towards safe use of medicines were limited to the side effects of the consumed medicines only, and to a lesser extent to the inappropriate indication and dosage. Most of the participants mentioned that gaining knowledge about the side effects of the prescribed drug was the main reason for reading the patient information leaflet. Quite a few participants have experienced side effects while consuming their medicines and they were unsure of how to deal with the situation. The current research also reflected the lack of proper communication between pharmacists and physicians in managing drug safety issues. Conclusively, the current research revealed gaps in public views regarding medication&#8217;s safety, which consequently may impact their attitudes during the course of medication use. Efforts need to be strengthened to enhance positive views and attitudes of the public towards medication safety and ADR reporting in the UAE