Suboptimal Implementation Research Articles

Perspectives and Attitudes of General Practitioners Towards Pharmacological and Non-Pharmacological COPD Management in a Belgian Primary Care Setting: A Qualitative Study.

Chronic obstructive pulmonary disease (COPD) is a complex and heterogeneous condition that requires multidisciplinary management. In Belgium, the treatment of COPD is mainly managed by general practitioners (GPs). Several clinical practice guidelines (CPGs) recommend the use of non-pharmacological treatments, such as pulmonary rehabilitation, and interdisciplinary care for COPD patients. Although considerable research has been devoted to addressing the multitude of reasons for the lack of adherence to these aspects of the CPGs, less attention has been paid to understanding the perspectives and attitudes of GPs that lead to this suboptimal implementation. This study aimed to 1) explore Belgian GPs' perceptions regarding COPD management in a primary care setting and 2) collect their views on the importance of pulmonary rehabilitation and interprofessional care in COPD management. A descriptive study, conducted between August 2014 and May 2015, used interviews from a sample of 30 Flemish GPs. Data were analyzed following the principles of thematic analysis. COPD management was patient-centered, focusing on immediate symptom relief and reducing future risks through pharmacotherapy and proper patient education. Deviations from the CPGs were noted, with only a few GPs performing spirometry themselves. Conditions to prescribe respiratory physiotherapy were not well known. Some GPs remained unconvinced about the (cost-)effectiveness of respiratory physiotherapy despite the fast-expanding scientific evidence. Interprofessional care was limited to GP-respiratory physician (re)-referral and communication. GPs showed a reactive attitude towards interprofessional collaboration for non-pharmacological therapies, which is not in line with the proactive approach recommended in CPGs. GPs managed COPD patients mainly by reducing symptoms with pharmacological therapy. Integrated care regarding non-pharmacological treatments was not well implemented due to the obstacles in interprofessional collaboration. Future care models incorporating personalized care planning could provide a solution to manage COPD's complex healthcare demands.

"HOW WILL I LIVE THIS LIFE I AM TRYING TO SAVE?": EXPLORING DUALITIES IN CANCER SURVIVORSHIP EXPERIENCES IN NIGERIA

Abstract Objectives. Cancer mortality rate is high in Nigeria with about 102,000 new cases and 72,000 deaths per year. Cancer incidence rate is projected to increase with its rapidly aging population and growth — emphasizing its growing cancer burden. Due to Nigeria’s weak health system, limited cancer therapy and expert oncological services, lack of cancer education and awareness, and sub-optimal implementation of its national cancer control plan, there is an increase in the risk of poor outcomes from cancer. To further understand the mechanism behind the poor outcomes, we explored cancer survivorship experiences of breast cancer survivors in Nigeria. Methods. The study employed a qualitative descriptive method. Semi-structured interviews were conducted with a purposive sample of 30 female breast cancer survivors in Abuja, Nigeria (Mage = 42 years). Their responses were transcribed, coded, and analyzed for themes. Results. The four major themes identified were: 1) life after cancer diagnosis (hope vs despair), 2) faith and religion (coping with faith vs issues with religion), 3) accessing cancer therapy (alternative therapy vs orthodox therapy), and 4) relationship with medical providers (encouragement from medical providers vs hinderance from medical providers). Discussion. Cancer death rates may be high but there is also a growing number of survivors in Nigeria. It is crucial to improve the health and well-being of Nigerians from the time of diagnosis until end of life, thus, the focus of cancer survivorship. The findings point to the critical need for policies to help strengthen cancer survivorship in Nigeria.

An Open-Access, Interactive Decision-Support Tool to Facilitate Guideline-Driven Care for Hepatocellular Carcinoma.

Hepatocellular carcinoma (HCC) is increasing in incidence and is a leading cause of cancer-related mortality worldwide. Adherence to HCC surveillance guidelines and appropriate treatment triage of liver lesions may improve receipt of curative-intent treatment and improved survival. Late-stage HCC diagnosis reflects sub-optimal implementation of effective HCC surveillance, whereas inappropriate treatment triage or linkage to care accounts for the non-receipt of curative-intent in close to half of early-stage HCC in the USA. A free, open-access decision-support tool for liver lesions that incorporates current guideline recommendations in a user-friendly interface could improve appropriate and timely triage of patients to appropriate care. This review provides a summary of gaps and disparities in linkage to HCC care and introduces a free, internet-based, interactive decision-support tool for managing liver lesions. This tool has been developed by the HCC Steering Committee of the Chronic Liver Disease Foundation and is targeted toward clinicians across specialties who may encounter liver lesions during routine care or as part of dedicated HCC surveillance.

Beyond checklists: Using clinic ethnography to assess the enabling environment for tuberculosis infection prevention control in South Africa.

Sub-optimal implementation of infection prevention and control (IPC) measures for airborne infections is associated with a rise in healthcare-acquired infections. Research examining contributing factors has tended to focus on poor infrastructure or lack of health care worker compliance with recommended guidelines, with limited consideration of the working environments within which IPC measures are implemented. Our analysis of compromised tuberculosis (TB)-related IPC in South Africa used clinic ethnography to elucidate the enabling environment for TB-IPC strategies. Using an ethnographic approach, we conducted observations, semi-structured interviews, and informal conversations with healthcare staff in six primary health clinics in KwaZulu-Natal, South Africa between November 2018 and April 2019. Qualitative data and fieldnotes were analysed deductively following a framework that examined the intersections between health systems 'hardware' and 'software' issues affecting the implementation of TB-IPC. Clinic managers and front-line staff negotiate and adapt TB-IPC practices within infrastructural, resource and organisational constraints. Staff were ambivalent about the usefulness of managerial oversight measures including IPC protocols, IPC committees and IPC champions. Challenges in implementing administrative measures including triaging and screening were related to the inefficient organisation of patient flow and information, as well as inconsistent policy directives. Integration of environmental controls was hindered by limitations in the material infrastructure and behavioural norms. Personal protective measures, though available, were not consistently applied due to limited perceived risk and the lack of a collective ethos around health worker and patient safety. In one clinic, positive organisational culture enhanced staff morale and adherence to IPC measures. 'Hardware' and 'software' constraints interact to impact negatively on the capacity of primary care staff to implement TB-IPC measures. Clinic ethnography allowed for multiple entry points to the 'problematic' of compromised TB-IPC, highlighting the importance of capturing dimensions of the 'enabling environment', currently not assessed in binary checklists.

How to tackle the global challenge of falls?

Worldwide, falls and accompanying injuries are increasingly common, making their prevention and management a critical global challenge. The wealth of evidence to support interventions to prevent falls has recently (2022) been distilled in the first World Falls Guideline for Prevention and Management for Older Adults. The core of falls prevention includes (i) risk assessment and stratification; (ii) general recommendations on optimising physical function and mobility for all and (iii) offering a holistic, multidomain intervention to older adults at high risk of falls, in which the older adult's priorities, beliefs and resources are carefully considered. In recent decades, sustainable and adequately resourced falls prevention has proved challenging, although evidence suggests that suboptimal implementation of falls prevention is ineffective. Future research should focus on understanding the most successful approaches for implementation. To further optimise falls prevention, recent developments include technological innovation to identify and prevent falls, including exergaming. Further work is warranted to understand how to best incorporate the concepts of frailty and sarcopenia in falls prevention and management. This themed collection includes key articles in the field of falls prevention, covering several topics including risk factors, effective interventions, older adult's views, implementation issues and future perspectives.

Implementation science: A critical but undervalued part of the healthcare innovation ecosystem

AbstractHealthcare systems face many competing demands and insufficient resources. Service innovations to improve efficiency are important to address this challenge. Innovations can range from new pharmaceuticals, alternate models of care, novel devices, and the use other technologies. Suboptimal implementation can mean lost benefits. This review article aims to highlight the role of implementation science, summarize how settings have leveraged this methodology to promote translation of innovation into practice, and describe our own experience of embedding implementation science into an academic medical center in Singapore. Implementation science offers a range of methods to promote systematic uptake of research findings about innovations and is gaining recognition worldwide as an important discipline for health services researchers. Health systems around the world have tried to promote implementation research in their settings by establishing (1) dedicated centers/programs, (2) offering funding, and (3) building knowledge and capacity among staff. Implementation science is a critical piece in the translational pathway of “evidence to innovation.” The three efforts we describe should be strengthened to integrate implementation science into the innovation ecosystem around the world.

Evaluation of the community-based outpatient therapeutic feeding program implementation for managing children with severe acute malnutrition in Northwest Ethiopia: A mixed-method evaluation protocol.

Community-based outpatient therapeutic feeding program (C-OTP) in Ethiopia has been launched to manage uncomplicated severe acute malnutrition (SAM) by trained Health Extension Workers (HEWs). This program is believed to be the most effective strategy for reaching a large group of children suffering from SAM in rural and disadvantaged communities. Nonetheless, poor treatment outcomes, notably mortality and prolonged recovery time, become pressing public health problems, which could be a result of suboptimal implementation and poor service quality. To evaluate the implementation of C-OTP for managing uncomplicated severe acute malnutrition in the Central Gondar Zone. Multiple studies involving both qualitative and quantitative will be conducted. Availability of essential drugs and equipment, acceptability of the program by mothers/caregivers, health extension workers' compliance to the treatment protocol, and treatment outcome will be assessed employing different methods. Likewise, knowledge of health extension workers about SAM diagnosis and management and their skills to diagnose and manage uncomplicated malnutrition will be determined. Health extension workers, mothers/caregivers, supervisors, and healthcare administrators will be enrolled in the study. Besides, children's medical records registered between 2017 and 2020 will be reviewed to determine the treatment outcome. The data will be collected using pretested self-administered and face-to-face interviewer-administered questionnaires. Similarly, focus group discussions (FGDs), in-depth interviews, and observation checklists will be applied. Binary logistic regression analysis will be conducted, while the qualitative data will be analyzed using thematic content analysis. Severe acute malnutrition is a public health problem that remains the underlying cause for over half of under-five mortality in Ethiopia. As a result, community-based therapeutic care has been launched in the country to address these problems and maximize population-level impact by improving treatment coverage, access, and cost-effectiveness. Despite its achievement, the program has been threatened with unfavourable treatment outcomes and a shortfall of resources. Hence, this implementation evaluation study will also identify gaps between healthcare systems and service users. The output will help programmers pass evidence-based and sound decisions to tackle the key barriers.

Investigating the quality of HIV rapid testing practices in public antenatal health care facilities, South Africa.

Monitoring HIV prevalence using antenatal HIV sentinel surveillance is important for efficient epidemic tracking, programme planning and resource allocation. HIV sentinel surveillance usually employs unlinked anonymous HIV testing which raises ethical, epidemiological and public health challenges in the current era of universal test and treat. The World Health Organization (WHO) recommends that countries should consider using routine prevention of mother-to-child transmission of HIV (PMTCT) data for surveillance. We audited antenatal care clinics to assess the quality of HIV rapid testing practices as the first step to assess whether South Africa is ready to utilize PMTCT programme data for antenatal HIV surveillance. In 2017, we conducted a cross-sectional survey in 360 randomly sampled antenatal care clinics using the adapted WHO Stepwise-Process-for-Improving-the-Quality-of-HIV-Rapid-Testing (SPI-RT) checklist. We calculated median percentage scores within a domain (domain-specific median score), and across all domains (overall median percentage scores). The latter was used to classify sites according to five implementation levels; (from 0:<40% to 4: 90% or higher). Of 346 (96.1%) facilities assessed, an overall median percentage score of 62.1% (inter-quartile range (IQR): 50.8-71.9%) was obtained. The lowest domain-specific median percentage scores were obtained under training/certification (35% IQR: 10.0-50.0%) and external quality assurance (12.5% IQR: 0.0-50.0%), respectively. The majority (89%) of sites had an overall median score at level 2 or below; of these, 37% required improvement in specific areas and 6.4% in all areas. Facilities in districts implementing the HIV Rapid Test Quality Improvement Initiative and supported by the President's Emergency Plan for AIDS Relief (PEPFAR) had significantly higher median overall scores (65.6% IQR: 53.9-74.2%) (P-value from rank sum test: <0.001) compared with non-PEPFAR-supported facilities (56.6% IQR:47.7-66.0%). We found sub-optimal implementation of HIV rapid testing practices. We recommend the expansion of the PEPFAR-funded Rapid Test Continuous Quality Improvement (RTCQI) support to all antenatal care testing sites.

Review and Assessment of Intellectual Property Policy Implementation in Tanzanian Universities and Research Institutions of Health and Sciences.

Intellectual Property Policy is one of the tools that can be used to address challenges faced by universities and research institutions in protecting and commercialising of products resulting from research activities. The aim of this study was to the review and assess the implementation of IP policies in universities and research institutions of health and allied sciences in Tanzania. This study targeted universities and research institutions of health sciences in Tanzania. Data was collected through in-depth interviews and review of intellectual property policy documents. Interviewed key informants indicated sub-optimal or lack of implementation of intellectual property policies in their respective institutions. Major reasons for lack or suboptimal implementation of intellectual property policy included limited awareness on existing institutions' intellectual property policy, and in some institutions, lack of guidelines and regulations for implementation of intellectual property policy, and not knowing how and the importance of protecting and exploiting intellectual property. Sub optimal and non-implementation of Intellectual Property policy in the studied institutions can be partly attributed to lack of policy guidelines and low awareness on intellectual property policy among staff members. Effective approaches for dissemination of approved Intellectual Property policy, regulations and guidelines will enhance its implementation and hence promote IP protection and commercialisation.

Implementation of the 2018 ESC/ESH Guidelines for the management of hypertension in primary care: the HYPEDIA study

The HYPEDIA study aimed at evaluating the implementation of the 2018 European guidelines for treating hypertension in primary care. A nationwide prospective non-interventional cross-sectional study was performed in consecutive untreated or treated hypertensives recruited mainly in primary care in Greece. Participants’ characteristics, office blood pressure (BP) (triplicate automated measurements, Microlife BPA3 PC) and treatment changes were recorded on a cloud platform. A total of 3,122 patients (mean age 64 ± 12.5 [SD] years, 52% males) were assessed by 181 doctors and 3 hospital centers. In 772 untreated hypertensives (25%), drug treatment was initiated in the majority, with monotherapy in 53.4%, two-drug combination in 36.3%, and three drugs in 10.3%. Angiotensin receptor blocker (ARB) monotherapy was initiated in 30%, ARB/calcium channel blocker (CCB) 20%, ARB/thiazide 8%, angiotensin converting enzyme inhibitor (ACEi)-based 19%. Of the combinations used, 97% were in single-pill. Among 977 treated hypertensives aged <65 years, 79% had BP ≥ 130/80 mmHg (systolic and/or diastolic), whereas among 1,373 aged ≥65 years, 66% had BP ≥ 140/80 mmHg. ARBs were used in 69% of treated hypertensives, CCBs 47%, ACEis 19%, diuretics 39%, beta-blockers 19%. Treatment modification was decided in 53% of treated hypertensives aged <65 years with BP ≥ 130/80 mmHg and in 62% of those ≥65 years with BP ≥ 140/80 mmHg. Renin-angiotensin system blocker-based therapy constitutes the basis of antihypertensive drug treatment in most patients in primary care, with wide use of single-pill combinations. In almost half of treated uncontrolled hypertensives, treatment was not intensified, suggesting suboptimal implementation of the guidelines and possible physician inertia.

Proposal for an Ambulatory Heart Failure Management Curriculum for Cardiology Residency Training Programs

BackgroundThe suboptimal implementation of guideline-directed medical therapy (GDMT) for heart failure (HF) patients has been linked with poor clinical outcomes. Little is known about the potential role of cardiology residency training programs in improving trainees’ (ie, future cardiologists’) ability to utilize GDMT. MethodsIn this survey-based study, we examined the degree of exposure to ambulatory HF patient management among cardiology trainees in Canada. All cardiology residency program directors (n = 15; 100% response rate) completed our survey. ResultsAlthough 9 programs (60%) mandated ≥ 3 ambulatory cardiology rotations, only 3 (20%) required ≥ 2 ambulatory HF rotations. When HF rotations were provided, only 7 programs (47%) offered moderate or higher exposure to ambulatory nontransplant HF patients (defined as ≥ 5 clinics/rotations). This element was independent of program- and institution-specific characteristics. All institutions had a multidisciplinary HF clinic, and the majority (13 [87%]) had access to an inpatient HF service, a consultative HF service, and/or a specialist pharmacist. Furthermore, 13 program directors (87%) agreed on the importance of adopting HF training curriculum and their program’s readiness to implement such a module. ConclusionsThe current state of HF training among cardiology residencies is suboptimal and in need of improvement. Most programs have access to a HF clinic, a specialist pharmacist, or an inpatient consultative service, which would facilitate adoption of a HF management curriculum that focuses on practical and experiential aspects of GDMT optimization. This program, which is under development, will be offered to training programs nationwide, to enable trainees to manage this growing and increasingly complex patient population.

Clinician Maladaptive Anxious Avoidance in the Context of Implementation of Evidence-Based Interventions: A Commentary.

This paper posits that a clinician's own anxious reaction to delivering specific evidence-based interventions (EBIs) should be better accounted for within implementation science frameworks. A key next step for implementation science is to delineate the causal processes most likely to influence successful implementation of evidence-based interventions (EBIs). This is critical for being able to develop tailored implementation strategies that specifically target mechanisms by which implementation succeeds or fails. First, we review the literature on specific EBIs that may act as negatively valenced stimuli for clinicians, leading to a process of clinician maladaptive anxious avoidance that can negatively impact EBI delivery. In the following sections, we argue that there are certain EBIs that can cause emotional distress or discomfort in a clinician, related to either: (1) a clinicians' fear of the real or predicted short-term distress the EBI can cause patients, or (2) fears that the clinician will inadvertently cause the patient harm and/or face liability. This distress experienced by the clinician can perpetuate a cycle of maladaptive anxious avoidance by the clinician, contributing to lack of or suboptimal EBI implementation. We illustrate how this cycle of maladaptive anxious avoidance can influence implementation by providing several examples from leading EBIs in the psychosocial literature. To conclude, we discuss how leveraging decades of treatment literature aimed at mitigating maladaptive anxious avoidance can inform the design of more tailored and effective implementation strategies for EBIs that are negatively valenced.

Improving implementation of evidence‐based therapies for heart failure

Treatment options for patients with heart failure have improved rapidly over the last few decades. Data from large scale clinical trials demonstrate that medical and device therapies can improve quality of life, reduce hospitalizations for acute heart failure, and reduce mortality. However, the use of many of these therapies in routine practice is remarkably low. There are many reasons for suboptimal implementation of evidence‐based therapies for heart failure, and we believe addressing the large gap between what can be accomplished in clinical trials versus routine practice is a critical and urgent public health issue. In this review, we outline reasons for this implementation gap and review recent studies attempting to address this issue. We also provide recommendations for future interventions and areas of clinical investigation to improve implementation for patients with heart failure.

Estimating Road Mortality Hotspots While Accounting for Imperfect Detection: A Case Study with Amphibians and Reptiles

Wildlife road mortality tends to aggregate spatially at locations commonly referred to as road mortality hotspots. Predictive models can be used to identify locations appropriate for mitigation measures that reduce road mortality. However, the influence of imperfect detection (e.g., false absences) during road mortality surveys can lead to inaccurate or imprecise spatial patterns of road mortality hotspots and suboptimal implementation of mitigation measures. In this research, we used amphibians and reptiles as a case study to address imperfect detection issues when estimating the probability of road mortality hotspots using occupancy detection modeling. In addition, we determined the survey effort needed to achieve a high probability of detecting large roadkill events. We also assessed whether vehicle travel reductions associated with the COVID-19 pandemic travel restrictions led to reductions in road mortality. We conducted surveys at 48 sites throughout Rhode Island, USA, from 2019–2021. In total, we observed 657 carcasses representing 19 of Rhode Island’s 37 native species. Of the 19 native species, eight species of frogs, four species of salamanders, four species of snakes, and three species of turtles were observed. We documented a reduction in roadkill density and the proportion of dead versus live amphibians and reptiles in pandemic years (2020 and 2021), but we were unable to link reductions in roadkill density to reductions in traffic volume. Our model results indicated that large roadkill events were more likely to occur on roads near wetlands and with low traffic volume and were more likely to be detected as daily precipitation increased. We determined that there was a low probability of detecting large roadkill events, suggesting that imperfect detection influences detection of large roadkill events, and many were likely missed during our surveys. Therefore, we recommend using occupancy modeling to account for the influence of imperfect detection when estimating road mortality hotspots. This approach will more effectively guide the implementation of mitigation measures.

Modified complex multitask Bayesian compressive sensing using Laplacian scale mixture prior

Bayesian compressive sensing (BCS) is an important sub-class of sparse signal reconstruction algorithms. In this paper, a modified complex multitask Bayesian compressive sensing (MCMBCS) algorithm using the Laplacian scale mixture (LSM) prior is proposed. The LSM prior is first introduced into the complex BCS framework by exploiting its better sparse characteristic and flexibility than traditional Laplacian prior. Furthermore, by integrating out the noise variance analytically, the MCMBCS algorithm significantly improves the signal recovery performance than the original CMBCS. More importantly, the authors not only present the iterative algorithm but also develop the sub-optimal fast implementation method based on the marginal likelihood maximisation, which dramatically reduce the computational complexity. Finally, sufficient numerical simulations validate the better performance of the proposed algorithm in reconstruction accuracy and computational effectiveness than existing work. It is revealed that the proposed algorithm has great potential in the complex-valued signal processing field.

HBSniff: A static analysis tool for Java Hibernate object-relational mapping code smell detection

Code smells are symptoms of sub-optimal software design and implementation choices. Detection tools were actively developed for general code smell related to coupling and cohesion issues, but such tools cannot capture domain-specific problems. In this work, we fill the gap in data persistence and query code quality by proposing HBSniff, i.e., a static analysis tool for detecting 14 code smells as well as 4 mapping metrics in Java Hibernate Object-Relational Mapping (ORM) codes. HBSniff is tested, documented, and manually validated. It also generates readable and customizable reports for every project. Moreover, it is beneficial to Mining Software Repository (MSR) research requiring large-scale analysis since project compilation is not needed for detection.

Statistical Modeling for Practical Pooled Testing During the COVID-19 Pandemic

Pooled testing offers an efficient solution to the unprecedented testing demands of the COVID-19 pandemic, despite their potentially lower sensitivity and increased costs to implementation in certain settings. Assessments of this trade-off typically assume the underlying infection statuses of pooled specimens to be independent and identically distributed. Yet, in the context of COVID-19, these assumptions are often violated: testing done on networks (housemates, spouses, co-workers) captures individuals with correlated infection statuses and risk, while infection risk varies substantially across time, place and individuals. Neglecting dependencies and heterogeneity may bias established optimality grids and induce a sub-optimal implementation of the procedure. As a lesson learned from this pandemic, this paper highlights the necessity of integrating field sampling information with statistical modeling to efficiently optimize pooled testing. Using real data, we show that (a) greater gains can be achieved at low logistical cost by exploiting natural correlations (nonindependence) between samples—allowing improvements in sensitivity and efficiency of up to 30% and 90%, respectively; and (b) these gains are robust despite substantial heterogeneity across pools (nonidentical). Our modeling results complement and extend the observations of Barak et al. (Sci. Transl. Med. 13 (2021) 1–8) who report an empirical sensitivity well beyond expectations. Finally, we provide an interactive tool for selecting an optimal pool size using contextual information.1 1 The corresponding shiny-app interface is available at: https://homecovidtests.shinyapps.io/Group-testing/.

The Good Behaviour Game intervention to improve behavioural and other outcomes for children aged 7–8 years: a cluster RCT

BackgroundUniversal, school-based behaviour management interventions can produce meaningful improvements in children’s behaviour and other outcomes. However, the UK evidence base for these remains limited.ObjectiveThe objective of this trial was to investigate the impact, value for money and longer-term outcomes of the Good Behaviour Game. Study hypotheses centred on immediate impact (hypothesis 1); subgroup effects (at-risk boys, hypothesis 2); implementation effects (dosage, hypothesis 3); maintenance/sleeper effects (12- and 24-month post-intervention follow-ups, hypothesis 4); the temporal association between mental health and academic attainment (hypothesis 5); and the health economic impact of the Good Behaviour Game (hypothesis 6).DesignThis was a two-group, parallel, cluster-randomised controlled trial. Primary schools (n = 77) were randomly assigned to implement the Good Behaviour Game for 2 years or continue their usual practice, after which there was a 2-year follow-up period.SettingThe trial was set in primary schools across 23 local authorities in England.ParticipantsParticipants were children (n = 3084) aged 7–8 years attending participating schools.InterventionThe Good Behaviour Game is a universal behaviour management intervention. Its core components are classroom rules, team membership, monitoring behaviour and positive reinforcement. It is played alongside a normal classroom activity for a set time, during which children work in teams to win the game to access the agreed rewards. The Good Behaviour Game is a manualised intervention delivered by teachers who receive initial training and ongoing coaching.Main outcome measuresThe measures were conduct problems (primary outcome; teacher-rated Strengths and Difficulties Questionnaire scores); emotional symptoms (teacher-rated Strengths and Difficulties Questionnaire scores); psychological well-being, peer and social support, bullying (i.e. social acceptance) and school environment (self-report Kidscreen survey results); and school absence and exclusion from school (measured using National Pupil Database records). Measures of academic attainment (reading, standardised tests), disruptive behaviour, concentration problems and prosocial behaviour (Teacher Observation of Child Adaptation Checklist scores) were also collected during the 2-year follow-up period.ResultsThere was no evidence that the Good Behaviour Game improved any outcomes (hypothesis 1). The only significant subgroup moderator effect identified was contrary to expectations: at-risk boys in Good Behaviour Game schools reported higher rates of bullying (hypothesis 2). The moderating effect of the amount of time spent playing the Good Behaviour Game was unclear; in the context of both moderate (≥ 1030 minutes over 2 years) and high (≥ 1348 minutes over 2 years) intervention compliance, there were significant reductions in children’s psychological well-being, but also significant reductions in their school absence (hypothesis 3). The only medium-term intervention effect was for peer and social support at 24 months, but this was in a negative direction (hypothesis 4). After disaggregating within- and between-individual effects, we found no temporal within-individual associations between children’s mental health and their academic attainment (hypothesis 5). Last, our cost–consequences analysis indicated that the Good Behaviour Game does not provide value for money (hypothesis 6).LimitationsLimitations included the post-test-only design for several secondary outcomes; suboptimal implementation dosage (mitigated by complier-average causal effect estimation); and moderate child-level attrition (18.5% for the primary outcome analysis), particularly in the post-trial follow-up period (mitigated by the use of full information maximum likelihood procedures).Future workQuestions remain regarding programme differentiation (e.g. how distinct is the Good Behaviour Game from existing behaviour management practices, and does this makes a difference in terms of its impact?) and if the Good Behaviour Game is impactful when combined with a complementary preventative intervention (as has been the case in several earlier trials).ConclusionThe Good Behaviour Game cannot be recommended based on the findings reported here.Trial registrationThis trial is registered as ISRCTN64152096.FundingThis project was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme and will be published in full inPublic Health Research; Vol. 10, No. 7. See the NIHR Journals Library website for further project information.

Researchers' perspectives on adverse event reporting in resistance training trials: a qualitative study.

The objectives of our study were to understand researchers' current practices and perspectives on adverse event (AE) reporting in clinical trials of resistance training (RT) and to identify barriers and facilitators of AE reporting. We conducted web conference or telephone-based one-on-one semistructured interviews with 14 researchers who have published RT studies. We audio-recorded and transcribed the interviews and analyzed the data using the thematic framework method. Four themes were identified: (1) researchers lack guidance and/or motivation for rigorous AE reporting; (2) researchers who undertake AE reporting educate and value participants, use trained personnel, and implement standardized guidelines; (3) suboptimal implementation of existing AE reporting standards and the perception that available guidelines do not apply to exercise trials; and (4) acceptability and feasibility of an exercise-specific guide for AE reporting depend on its content and format. In conclusion, AE reporting methods in the field of exercise science do not align with best practice. Strategies to reduce inconsistent and suboptimal AE reporting in RT trials are urgently needed and could be based on the barriers and facilitators identified in this study.

Global Oral Anticoagulation Use Varies by Region in Patients With Recent Diagnosis of Atrial Fibrillation: The GLORIA-AF Phase III Registry.

BackgroundEffective stroke prevention with oral anticoagulants (OAC) is recommended for some patients with atrial fibrillation (AF). We aimed to describe OAC use by geographical region and type of site in patients with recent‐onset AF enrolled in a large global registry.Methods and ResultsEligible participants were recruited into GLORIA‐AF (Global Registry on Long‐Term Oral Antithrombotic Treatment in Patients With Atrial Fibrillation), a prospective observational cohort study from 2014 to 2016 in 4 international regions: North America, Europe, Asia, and Latin America. Cumulative incidence functions were generated for direct OACs (DOAC), vitamin K antagonists, and antiplatelet drugs considering competing risks, stratified by region and type of site. Time‐to‐treatment initiation after AF diagnosis was analyzed with Fine‐Gray subdistribution hazard models. A total of 21 237 patients eligible for analysis were identified. By 30 days after AF diagnosis, 40%, 16%, and 8.6% of patients had DOAC, vitamin K antagonists, and antiplatelet drugs initiated, respectively. Earlier initiation of DOACs was observed in Europe, with Asia and Latin America having lower hazard rates of DOAC time‐to‐treatment initiation than Europe (hazard ratio [HR], 0.66; 95% CI, 0.62–0.70 and HR, 0.79; 95% CI, 0.73–0.85, respectively). DOAC initiation was highest in community hospitals, vitamin K antagonists in outpatient health care centers/anticoagulation clinics, and antiplatelet drugs in primary care clinics.ConclusionsImportant geographic variability exists with the use of OACs for patients with AF. Differences in the time‐to‐treatment initiation of OAC by type of site suggests suboptimal implementation of guideline recommendations and could result in less benefit and more harm. Optimizing OAC use for patients with AF may improve outcomes and reduce health care costs.RegistrationURL: http://www.clinicaltrials.gov; Unique identifiers: NCT01468701, NCT01671007.