Beliefs About Medication and Uptake of Preventive Therapy in Women at Increased Risk of Breast Cancer: Results From a Multicenter Prospective Study

Introduction Uptake of preventive therapies for breast cancer is low. We examined whether women at increased risk of breast cancer can be categorized into groups with similar medication beliefs, and whether belief group membership was prospectively associated with uptake of preventive therapy. Patients and Methods Women (n = 732) attending an appointment to discuss breast cancer risk were approached; 408 (55.7%) completed the Beliefs About Medicines and the Perceived Sensitivity to Medicines questionnaires. Uptake of tamoxifen at 3 months was reported in 258 (63.2%). The optimal number of belief groups were identified using latent profile analysis. Results Uptake of tamoxifen was 14.7% (38/258). One in 5 women (19.4%; 78/402) reported a strong need for tamoxifen. The model fit statistics supported a 2-group model. Both groups held weak beliefs about their need for tamoxifen for current and future health. Group 2 (38%; 154/406 of the sample) reported stronger concerns about tamoxifen and medicines in general, and stronger perceived sensitivity to the negative effects of medicines compared with group 1 (62%; 252/406). Women with low necessity and lower concerns (group 1) were more likely to initiate tamoxifen (18.3%; 33/180) than those with low necessity and higher concerns (group 2) (6.4%; 5/78). After adjusting for demographic and clinical factors, the odds ratio was 3.37 (95% confidence interval, 1.08-10.51; P = .036). Conclusion Uptake of breast cancer preventive therapy was low. A subgroup of women reported low need for preventive therapy and strong medication concerns. These women were less likely to initiate tamoxifen. Medication beliefs are targets for supporting informed decision-making

Peri-operative red blood cell transfusion in neonates and infants: NEonate and Children audiT of Anaesthesia pRactice IN Europe: A prospective European multicentre observational study

BACKGROUND: Little is known about current clinical practice concerning peri-operative red blood cell transfusion in neonates and small infants. Guidelines suggest transfusions based on haemoglobin thresholds ranging from 8.5 to 12 g dl-1, distinguishing between children from birth to day 7 (week 1), from day 8 to day 14 (week 2) or from day 15 (≥week 3) onwards. OBJECTIVE: To observe peri-operative red blood cell transfusion practice according to guidelines in relation to patient outcome. DESIGN: A multicentre observational study. SETTING: The NEonate-Children sTudy of Anaesthesia pRactice IN Europe (NECTARINE) trial recruited patients up to 60 weeks' postmenstrual age undergoing anaesthesia for surgical or diagnostic procedures from 165 centres in 31 European countries between March 2016 and January 2017. PATIENTS: The data included 5609 patients undergoing 6542 procedures. Inclusion criteria was a peri-operative red blood cell transfusion. MAIN OUTCOME MEASURES: The primary endpoint was the haemoglobin level triggering a transfusion for neonates in week 1, week 2 and week 3. Secondary endpoints were transfusion volumes, 'delta haemoglobin' (preprocedure - transfusion-triggering) and 30-day and 90-day morbidity and mortality. RESULTS: Peri-operative red blood cell transfusions were recorded during 447 procedures (6.9%). The median haemoglobin levels triggering a transfusion were 9.6 [IQR 8.7 to 10.9] g dl-1 for neonates in week 1, 9.6 [7.7 to 10.4] g dl-1 in week 2 and 8.0 [7.3 to 9.0] g dl-1 in week 3. The median transfusion volume was 17.1 [11.1 to 26.4] ml kg-1 with a median delta haemoglobin of 1.8 [0.0 to 3.6] g dl-1. Thirty-day morbidity was 47.8% with an overall mortality of 11.3%. CONCLUSIONS: Results indicate lower transfusion-triggering haemoglobin thresholds in clinical practice than suggested by current guidelines. The high morbidity and mortality of this NECTARINE sub-cohort calls for investigative action and evidence-based guidelines addressing peri-operative red blood cell transfusions strategies. TRIAL REGISTRATION: ClinicalTrials.gov, identifier: NCT02350348

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

Theory and practical guidance for effective de-implementation of practices across health and care services:a realist synthesis

Abstract Background Health-care systems across the globe are facing increased pressures to balance the efficient use of resources and at the same time provide high-quality care. There is greater requirement for services to be evidence based, but practices that are of limited clinical effectiveness or cost-effectiveness still occur. Objectives Our objectives included completing a concept analysis of de-implementation, surfacing decision-making processes associated with de-implementing through stakeholder engagement, and generating an evidence-based realist programme theory of ‘what works’ in de-implementation. Design A realist synthesis was conducted using an iterative stakeholder-driven four-stage approach. Phase 1 involved scoping the literature and conducting stakeholder interviews to develop the concept analysis and an initial programme theory. In Phase 2, systematic searches of the evidence were conducted to test and develop this theory, expressed in the form of contingent relationships. These are expressed as context–mechanism–outcomes to show how particular contexts or conditions trigger mechanisms to generate outcomes. Phase 3 consisted of validation and refinement of programme theories through stakeholder interviews. The final phase (i.e. Phase 4) formulated actionable recommendations for service leaders. Participants In total, 31 stakeholders (i.e. user/patient representatives, clinical managers, commissioners) took part in focus groups and telephone interviews. Data sources Using keywords identified during the scoping work and concept analysis, searches of bibliographic databases were conducted in May 2018. The databases searched were the Cochrane Library, Campbell Collaboration, MEDLINE (via EBSCOhost), the Cumulative Index to Nursing and Allied Health Literature (via EBSCOhost), the National Institute for Health Research Journals Library and the following databases via the ProQuest platform: Applied Social Sciences Index and Abstracts, Social Services Abstracts, International Bibliography of the Social Sciences, Social Sciences Database and Sociological Abstracts. Alerts were set up for the MEDLINE database from May 2018 to December 2018. Online sources were searched for grey literature and snowballing techniques were used to identify clusters of evidence. Results The concept analysis showed that de-implementation is associated with five main components in context and over time: (1) what is being de-implemented, (2) the issues driving de-implementation, (3) the action characterising de-implementation, (4) the extent that de-implementation is planned or opportunistic and (5) the consequences of de-implementation. Forty-two papers were synthesised to identify six context–mechanism–outcome configurations, which focused on issues ranging from individual behaviours to organisational procedures. Current systems can perpetuate habitual decision-making practices that include low-value treatments. Electronic health records can be designed to hide or remove low-value treatments from choice options, foregrounding best evidence. Professionals can be made aware of their decision-making strategies through increasing their attention to low-value practice behaviours. Uncertainty about diagnosis or patients’ expectations for certain treatments provide opportunities for ‘watchful waiting’ as an active strategy to reduce inappropriate investigations and prescribing. The emotional component of clinician–patient relationships can limit opportunities for de-implementation, requiring professional support through multimodal educational interventions. Sufficient alignment between policy, public and professional perspectives is required for de-implementation success. Limitations Some specific clinical issues (e.g. de-prescribing) dominate the de-implementation evidence base, which may limit the transferability of the synthesis findings. Any realist inquiry generates findings that are essentially cumulative and should be developed through further investigation that extends the range of sources into, for example, clinical research and further empirical studies. Conclusions This review contributes to our understanding of how de-implementation of low-value procedures and services can be improved within health-care services, through interventions that make professional decision-making more accountable and the prominence of a whole-system approach to de-implementation. Given the whole-system context of de-implementation, a range of different dissemination strategies will be required to engage with different stakeholders, in different ways, to change practice and policy in a timely manner

Perioperative critical events and morbidity associated with anesthesia in early life: subgroup analysis of United Kingdom participation in the neonate and children audit of anesthesia practice in Europe (NECTARINE) prospective multicenter observational study

BACKGROUND: The NEonate and Children audiT of Anaesthesia pRactice IN Europe (NECTARINE) prospective observational study reported critical events requiring intervention during 35.2% of 6542 anesthetic episodes in 5609 infants up to 60 weeks postmenstrual age. The United Kingdom (UK) was one of 31 participating countries. METHODS: Subgroup analysis of UK NECTARINE cases (12.8% of cohort) to identify perioperative critical events that triggered medical interventions. Secondary aims were to describe UK practice, identify factors more commonly associated with critical events, and compare 30-day morbidity and mortality between participating UK and non-UK centers. RESULTS: Seventeen UK centers recruited 722 patients (68.7% male, 36.1% born preterm, 48.1% congenital anomalies) undergoing anesthesia for 876 surgical or diagnostic procedures at 25-60 weeks postmenstrual age. Repeat anesthesia/surgery was common: 17.6% patients prior to and 14.4% during the recruitment period. Perioperative critical events triggered interventions in 300/876 (34.3%) cases. Cardiovascular instability (16.9% of cases) and/or reduced oxygenation (11.4%) were more common in younger patients and those with co-morbidities or requiring preoperative intensive support. A higher proportion of UK than non-UK cases were graded as ASA-Physical Status scores >2 or requiring urgent or emergency procedures, and 39% required postoperative intensive care. Thirty-day morbidity (complications in 17.2%) and mortality (8/715, 1.1%) did not differ from non-UK participants. CONCLUSIONS: Perioperative critical events and co-morbidities are common in neonates and young infants. Thirty-day morbidity and mortality data did not demonstrate national differences in outcome. Identifying factors associated with increased risk informs preoperative assessment, resource allocation, and discussions between clinicians and families