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Efficacy and moderators of cognitive behavioural therapy versus interpersonal psychotherapy for adult depression: study protocol of a systematic review and individual participant data meta-analysis

Por: Lin · T. · Cohen · Z. D. · Stefan · S. · Soflau · R. · Fodor · L. A. · Georgescu · R. · Bruijniks · S. J. E. · Lemmens · L. · Bagby · M. · Quilty · L. · Ekeblad · A. · Holmqvist · R. · Evans · J. · OMahen · H. A. · Johnson · J. E. · Zlotnick · C. · Hilpert · P. · Carter · J. · McBride · C.
Introduction

Cognitive behavioural therapy (CBT) and interpersonal psychotherapy (IPT) are both efficacious treatments for depression, but it is less clear how both compare on outcome domains other than depression and in the longer term. Moreover, it is unclear which of these two psychotherapies works better for whom. This article describes the protocol for a systematic review and individual participant data (IPD) meta-analysis that aims to compare the efficacy of CBT and IPT for adults with depression on a range of outcomes in both the short and long term, and to explore moderators of the treatment effect. This study can enhance our understanding of treatments for depression and inform treatment personalisation.

Methods and analysis

Systematic literature searches will be conducted in PubMed, PsycINFO, EMBASE and the Cochrane Library from inception to 1 January 2026, to identify randomised clinical trials (RCTs) comparing CBT and IPT for adult depression. Researchers of eligible studies will be invited to contribute their participant-level data. One-stage IPD meta-analyses will be conducted with mixed-effects models to examine (a) treatment efficacy on all outcome measures that are assessed at post-treatment or follow-up in at least two studies, and (b) various baseline participant characteristics as potential moderators of depressive symptom level at treatment completion.

Ethics and dissemination

Ethical approval is not required for this study since it will be based on anonymised data from RCTs that have already been completed. The findings of the present study will be disseminated through a peer-reviewed journal or conference presentation.

Study protocol for a multi-site case study evaluation of a Canadian quality improvement collaborative to improve Baby-Friendly practices in community health services

Por: Turner · S. E. · Enns · J. E. · Seager · E. · LeDrew · M. · Benoit · B. · Semenic · S. · Snelgrove-Clarke · E. · Shittu · B. · Gordon Pappas · D. · CBFI-C Implementation and Evaluation Team · Nickel · N. C. · Campbell-Yeo · Frittenburg · Haiek · McClure · Rashid · Swan · Abbass-Di
Introduction

In Canada, many families want to breastfeed, but there are several common challenges they may encounter. Currently, 91% of Canadian families initiate breastfeeding after giving birth, yet only 38% of babies are breastfed exclusively to 6 months. In 1991, the Breastfeeding Committee for Canada (BCC) was established to implement the World Health Organization’s Ten-Step Baby-Friendly Hospital Initiative, a series of evidence-based in-hospital practices to support families to breastfeed. Then, in recognition of the need to support breastfeeding beyond the hospital setting, the BCC expanded the Baby-Friendly Initiative (BFI) to apply the Ten Steps to both hospitals and community health settings. However, uptake of the BFI Ten Steps in community settings has been low and methodology on how to optimise implementation of the Ten Steps in community is not well developed. Therefore, the objective of this project is to develop and evaluate a quality improvement collaborative with 25 community health services from across Canada to learn how to best support the implementation of the BFI Ten Steps in community, with the ultimate goal of improving breastfeeding outcomes.

Methods and analysis

This protocol describes the activities of the Community Baby-Friendly Initiative Collaborative (CBFI-C) and the methods used to evaluate its effectiveness. We will use the Institute for Healthcare Information Breakthrough Series (IHI-BTS) model, a proven quality improvement model that has been widely used in clinical settings, but is not yet widely used in community settings. The IHI-BTS combines three virtual learning sessions with action cycles that allow the participating sites time to test and track small practice changes. Sites will be asked to track care indicator and breastfeeding outcome data, engage in monthly webinars, receive coaching from trained mentors, participate in focus groups and participate in a final summative workshop. We will use a multi-site case study approach, combining aggregate care indicator data and qualitative data from webinars, focus groups and workshops to evaluate how the CBFI-C model supports community sites in the process of implementing the BFI Ten Steps.

Ethics and dissemination

Ethics approval for this evaluation was obtained from the CHIPER Health Research Ethics Board (Number HS26947-H2025:157)). The results of the CBFI-C evaluation will be shared in a report, peer-reviewed publications and presentations to government and academic audiences. The findings will inform effective quality improvement strategies to enhance uptake of the BFI in community health settings.

Preferences and predictors driving opioid-involved polysubstance use profiles and trajectories: a prospective cohort study protocol

Por: Campbell · M. · Lafayette · J. I. · Vallejo Vasquez · K. · Rivard · A. · Diamond · J. · Nguyen · C. · Caputo · D. · Lothumalla · S. · Rodriguez · C. R. · Tomlinson · D. C. · Bonar · E. E. · Goldstick · J. E. · Walton · M. · Lee · S. · Menke · N. · Lin · L. · Coughlin · L. N.
Introduction

Polysubstance use (PSU), particularly opioid-involved and stimulant-involved PSU, is a growing issue in the USA. PSU increases the risk of negative health consequences, including infectious diseases, worsening physical and mental health conditions, and overdose-related deaths. These consequences occur in the context of varying health risk behaviours, substance-related preferences, and treatment engagements among people with PSU. To inform improvements in prevention, harm reduction, and substance use disorder (SUD) treatment, additional research is needed to comprehensively understand the current context and drivers of PSU preferences, motivations, and behaviours.

Methods and analysis

Herein, we describe the protocol for a prospective cohort study designed to capture detailed patterns, profiles, and trajectories of PSU, with the aim of comprehensively examining the drivers of PSU behaviours and SUD treatment utilisation. Adults (ages 18–75; n=400) who engage in PSU will be recruited from healthcare institutions, an established participant database maintained by an adjacent SUD research team, and online advertisements. Study assessments will capture dynamic patterns, choice preferences, and motivators of PSU via behavioural economic (BE) measures, detailed Timeline Follow-Back (TLFB) interviews, and self-administered surveys. The assessment timeline will include a baseline survey and TLFB interview, weekly TLFB interviews for 4 weeks post-baseline, and follow-up surveys and TLFB interviews at 4-, 8-, and 12-months post-baseline.

Ethics and dissemination

The study is funded through the National Institutes of Health Helping to End Addiction Long-term (HEAL) initiative and was approved by the University of Michigan Medical Institutional Review Board. Findings will be disseminated to academic, clinical, and community partners through the Michigan Innovations in Addiction Care through Research and Education programme. Results from this study will inform actionable and practical insights relevant to the delivery of personalised care in the context of PSU.

How do musculoskeletal disorders impact on quality of life in Tanzania? Results from a community-based survey

Por: Grieve · E. · Deidda · M. · Krauth · S. J. · Biswaro · S. M. · Halliday · J. E. B. · Hsieh · P.-H. · Kelly · C. · Kilonzo · K. · Kiula · K. P. · Kolimba · R. · Msoka · E. F. · Siebert · S. · Walker · R. · Yongolo · N. M. · Mmbaga · B. · McIntosh · E. · NIHR Global Health Group · Biswaro
Objectives

There are little available data on the prevalence, economic and quality of life impacts of musculoskeletal disorders in sub-Saharan Africa. This lack of evidence is wholly disproportionate to the significant disability burden of musculoskeletal disorders as reported in high-income countries. Our research aimed to undertake an adequately powered study to identify, measure and value the health impact of musculoskeletal conditions in the Kilimanjaro region, Tanzania.

Design

A community-based cross-sectional survey was undertaken between January 2021 and September 2021. A two-stage cluster sampling with replacement and probability proportional to size was used to select a representative sample of the population.

Setting

The survey was conducted in 15 villages in the Hai District, Kilimanjaro region, Tanzania.

Participants

Economic and health-related quality of life (HRQOL) questionnaires were administered to a sample of residents (aged over 5 years old) in selected households (N=1050). There were a total of 594 respondents, of whom 153 had a confirmed musculoskeletal disorder and 441 matched controls. Almost three-quarters of those identified as having a musculoskeletal disorder were female and had an average age of 66 years.

Primary and secondary outcome measures

Questions on healthcare resource use, expenditure and quality of life were administered to all participants, with additional more detailed economic and quality of life questions administered to those who screened positive, indicating probable arthritis.

Results

There is a statistically significant reduction in HRQOL, on average 25% from a utility score of 0.862 (0.837, 0.886) to 0.636 (0.580, 0.692) for those identified as having a musculoskeletal disorder compared with those without. The attributes ‘pain’ and ‘discomfort’ were the major contributors to this reduction in HRQOL.

Conclusions

This research has revealed a significant impact of musculoskeletal conditions on HRQOL in the Hai district in Tanzania. The evidence will be used to guide clinical health practices, interventions design, service provisions and health promotion and awareness activities at institutional, regional and national levels.

The Associations Between Nurses' Perceived Adequacy of Staffing and Quality of Nursing Care and Job Enjoyment: A Multilevel Modelling Approach

ABSTRACT

Aim

To explore the associations of (1) shift-to-shift Nurse Perceived Adequacy of Staffing Scale (NPASS) scores and (2) the relative contribution of individual NPASS items to nurse-perceived quality of care (NPQoC) and job enjoyment.

Design

Multihospital prospective observational study.

Methods

The study was conducted across 15 medical, surgical or acute admission hospital wards in three teaching hospitals in the Netherlands. Vocationally and bachelor-trained nurses conducted 1550 measurements of perceived adequacy of staffing using the NPASS, NPQoC and job enjoyment in 797 shifts. Multilevel models were used to assess associations between NPASS scores and NPASS items and the outcome variables.

Results

Higher NPASS scores were significantly associated with improved NPQoC and job enjoyment. An increase in 1.0 point NPASS score leads to an increase of 0.97 points in NPQoC and 1.04 points in job enjoyment. Of the NPASS items, energy level, adherence to protocols and the opportunity for adequate breaks had the most positive effect on both outcomes.

Conclusion

Perceived adequacy of staffing as measured by the NPASS is highly relevant for improvements in both NPQoC and job enjoyment.

Implications for the Profession and/or Patient Care

Decision-makers on nurse staffing should incorporate the NPASS in staffing methods to ensure adequate staffing and the associated benefits. Policies that ensure adequate breaks, adherence to protocols and maintenance of nurses' energy levels during the shift should be implemented with special attention.

Impact

This study provides supportive evidence for incorporating nurses' perceived adequacy of staffing, as measured by the NPASS, to ensure adequate staffing. This is crucial for nurse retention, and therefore vital to maintaining accessible healthcare given the global nursing shortages.

Reporting Method

The STROBE checklist was used to conduct and describe the study.

Patient or Public Contribution

This study did not include patient or public involvement in its design, conduct or reporting.

Protocol for the process evaluation of a randomised clinical trial of incremental-start versus conventional haemodialysis: the TwoPlus study

Por: Murea · M. · Foley · K. L. · Gautam · S. C. · Flythe · J. E. · Raimann · J. G. · Abdel-Rahman · E. · Awad · A. S. · Niyyar · V. D. · Kovach · C. · Roberts · G. V. · Jefferson · N. M. · Conway · P. T. · Rosales · L. M. · Woldemichael · J. · Sheikh · H. I. · Raman · G. · Huml · A. M. · Kni
Introduction

Process evaluation provides insight into how interventions are delivered across varying contexts and why interventions work in some contexts and not in others. This manuscript outlines the protocol for a process evaluation embedded in a hybrid type 1 effectiveness-implementation randomised clinical trial of incremental-start haemodialysis (HD) versus conventional HD delivered to patients starting chronic dialysis (the TwoPlus Study). The trial will simultaneously assess the effectiveness of incremental-start HD in real-world settings and the implementation strategies needed to successfully integrate this intervention into routine practice. This manuscript describes the rationale and methods used to capture how incremental-start HD is implemented across settings and the factors influencing its implementation success or failure within this trial.

Methods and analysis

We will use the Consolidated Framework for Implementation Research (CFIR) and the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) frameworks to inform process evaluation. Mixed methods include surveys conducted with treating providers (physicians) and dialysis personnel (nurses and dialysis administrators); semi-structured interviews with patient participants, caregivers of patient participants, treating providers (physicians and advanced practice practitioners), dialysis personnel (nurses, dieticians and social workers); and focus group meetings with study investigators and stakeholder partners. Data will be collected on the following implementation determinants: (a) organisational readiness to change, intervention acceptability and appropriateness; (b) inner setting characteristics underlying barriers and facilitators to the adoption of HD intervention at the enrollment centres; (c) external factors that mediate implementation; (d) adoption; (e) reach; (f) fidelity, to assess adherence to serial timed urine collection and HD treatment schedule; and (g) sustainability, to assess barriers and facilitators to maintaining intervention. Qualitative and quantitative data will be analysed iteratively and triangulated following a convergent parallel and pragmatic approach. Mixed methods analysis will use qualitative data to lend insight to quantitative findings. Process evaluation is important to understand factors influencing trial outcomes and identify potential contextual barriers and facilitators for the potential implementation of incremental-start HD into usual workflows in varied outpatient dialysis clinics and clinical practices. The process evaluation will help interpret and contextualise the trial clinical outcomes’ findings.

Ethics and dissemination

The study protocol was approved by the Wake Forest University School of Medicine Institutional Review Board (IRB). Findings from this study will be disseminated through peer-reviewed journals and scientific conferences.

Trial registration number

NCT05828823.

COVID-19 antibody testing study: a nested substudy within Albertas Tomorrow Project (ATP) in Alberta, Canada

Por: Nejatinamini · S. · Charlton · C. · Harman · S. · Kanji · J. N. · Kellner · J. D. · Lines · K. · Murdoch · K. · Powell · W. · Roberts · J. · Rosner · W. · Shen-Tu · G. · Tipples · G. · Xu · J.-Y. · Vena · J. E.
Purpose

The Alberta’s Tomorrow Project (ATP) prospective cohort study was established in 2000 to investigate the causes of cancer and chronic disease. The cohort consists of almost 55 000 participants aged 35–69 years at the time of recruitment. From 2020 to 2022, ATP conducted a longitudinal substudy, the COVID-19 Antibody Testing (CAT) study, nested in this existing cohort, to understand the spread and impact of the SARS-CoV-2. In this cohort profile, we describe the CAT study design, recruitment and initial findings.

Participants

In this prospective cohort substudy, ~4000 participants completed online surveys and provided blood samples at a study centre every 4 months for 1 year, across four cities in Alberta, Canada. The study was launched on a rolling basis beginning in September 2020 and data collection was completed in May 2022. The surveys collected information on health and lifestyle factors, COVID-19 (testing, symptoms, vaccination, public health recommendations) and impacts of the pandemic (including economic, health services, mental health). Blood samples were tested for antinucleocapsid and antispike protein SARS-CoV-2 antibodies.

Findings to date

A total of 4102 participants consented and attended a study centre at baseline, and almost 90% of these completed the study. Overall, participants were aged 61±10 years, 60% female, 12% came from rural areas, 45% had at least a bachelor’s degree, 24% reported a household income 4 weeks). By the end of the study, 96% of participants had received at least one COVID-19 vaccine dose. Through investigating other outcomes, it was observed that participants under 50 years of age were more likely to be assessed to have mild or moderate-to-severe anxiety and depressive symptoms compared with older participants. In addition, approximately 15% of participants reported a moderate to major impact on their ability to meet financial obligations.

Future plans

Serology results, together with health, lifestyle and sociodemographic data, and the continued follow-up of these participants as part of the broader ATP cohort study (planned through 2065), will provide opportunities to investigate the long-term sequelae of COVID-19 infection as well as the broader impacts of the pandemic on physical, mental and emotional health. Data are available to researchers on request through the ATP access process.

Acute myocardial infarction diagnosis and treatment following implementation of a multicomponent intervention in Tanzania: the MIMIC pilot trial

Por: Hertz · J. T. · Nworie · J. E. · Shayo · F. · Galson · S. W. · Coaxum · L. A. · Daniel · I. · Makambay · P. S. · Akrabi · A. M. · Manyangu · G. J. · Thielman · N. M. · Bloomfield · G. · Sakita · F. M.
Background

In Tanzania, acute myocardial infarction (AMI) is underdiagnosed, and uptake of evidence-based care is suboptimal. Using an implementation science approach, an intervention was developed to address local barriers to care: the Multicomponent Intervention for Improving Myocardial Infarction Care in Tanzania (MIMIC).

Methods

This sequential cohort design trial was conducted in a single northern Tanzanian emergency department (ED). During the preintervention phase (February–August 2023) and the postintervention phase (September 2023–August 2024), adults presenting with chest pain and/or dyspnoea were prospectively enrolled and their ED care was observed. AMI was defined by the Fourth Universal Definition criteria. Telephone follow-ups were conducted to ascertain 30-day mortality. Pearson’s ² was used to compare care before and after MIMIC implementation.

Results

A total of 275 participants were enrolled in the preintervention phase and 577 were enrolled in the postintervention phase. Following MIMIC implementation, significant increases were observed in ECG testing (89.4% of postintervention participants vs 55.3% preintervention, OR 6.82, 95% CI 4.79 to 9.79, p

Conclusions

The MIMIC intervention was associated with large increases in uptake of AMI testing, case identification and evidence-based treatment in a single Tanzanian ED. Multisite studies are needed to evaluate the effect of MIMIC on AMI care in diverse settings across Tanzania.

Trial registration number

NCT04563546.

Aspirin to prevent cardiovascular events in patients with community-acquired pneumonia or influenza (ASCAP study): protocol for a multicentre, randomised, double-blind, placebo-controlled trial

Por: Hovsepjan · V. · Thijs · A. · van Diemen · J. J. K. · Bogaards · J. A. · Winter · M. M. · Bosmans · J. E. · Prins · J. M. · ASCAP study group · Altenburg · Bogaards · Bosmans · van Diemen · Hovsepjan · Prins · Thijs · Winter · Fritsma-Terwisscha van Scheltinga · Weijer · Berk · H
Introduction

Cardiovascular events (CVEs), in particular acute coronary syndrome (ACS), complicate the course of a significant number of patients hospitalised for community-acquired pneumonia (CAP) or influenza. Emerging evidence suggests that this increased risk of CVEs could be mitigated by the use of acetylsalicylic acid (aspirin). The ASCAP study investigates whether the addition of aspirin to standard therapy in hospitalised patients with moderate-to-severe CAP or influenza can reduce the incidence of CVEs.

Methods and analysis

The ASCAP study is a multicentre, double-blind, placebo-controlled randomised trial in 16 university and general hospitals in the Netherlands, in which patients are randomised to acetylsalicylic acid or matching placebo for 90 days. Eligible patients are adults hospitalised for moderate-to-severe CAP or influenza. Patients with antithrombotic or anticoagulant drugs, or those with contraindications for aspirin, are excluded. The primary outcome is the incidence of ACS up to day 180. Secondary outcomes include the incidence of 4-point major adverse cardiovascular events up to day 180, as well as the incidence of major bleeding and clinically relevant non-major bleeding events up to day 90, all-cause mortality up to day 180 and quality of life and societal costs up to day 180. Survival time will be analysed by the log-rank test, stratified for CAP and influenza, with a two-sided alpha of 0.05. Assuming an average baseline ACS risk of 7.5% over 180 days with up to 30% variation across strata, and a 60% hazard reduction due to aspirin, the required sample size to achieve 80% power is 760 patients. Currently, 114 patients are enrolled in the study.

Ethics and dissemination

This study is approved by the Medical Ethics Committee Amsterdam UMC (Amsterdam, The Netherlands) under reference number 2023.0741 and registered under EU trial number 2023-504553-12-01 in the EU portal CTIS (Clinical Trials Information System). Results of the study will be published in a peer-reviewed journal.

Trial registration number

EU CTIS: 2023-504553-12-01.

Examining the role of staff and team communication in reducing seclusion, restraint and forced tranquilisation in acute inpatient mental health settings: protocol for the Communication and Restraint Reduction (CaRR) study

Por: Cibelli · F. · Forbes · T. · McCabe · R. · Anderson · J. E. · Hoe · J. · Tahir · S. · McKeown · G. J. · Brew · B. · Deamer · F. · Lavelle · M.
Introduction

Over 100 000 service users are admitted to acute mental health wards annually, many involuntarily. Wards are under incredible pressure due to high bed occupancy rates and staff shortages. In a recent survey, over 80% of mental health nurses reported experiencing aggression and violence within their role. National and international policy dictates that mental health ward staff manage incidents of aggression and violence using communication, known as de-escalation. However, de-escalation practice is variable, and there is little empirical evidence to underpin training. As such, there is still a reliance on more restrictive practices, including seclusion and physical restraint.

Aim

The aim of this study is to identify the communication and organisational factors that characterise effective management of service users’ behaviour and distress in acute adult inpatient mental health wards, reducing the reliance on more restrictive practices (eg, seclusion and restraint).

Methods and analysis

This observational study will be conducted on mental health wards in England. It will be comprised of three work packages (WPs).

  • A microanalysis of communication during de-escalation incidents from Body Worn Camera footage on wards (n=64), to identify staff communication practices that lead to effective management of service users’ distress.

  • Ethnographic observations of ward routine practice, alongside interviews and questionnaires with staff and service users, to examine how challenging behaviour is anticipated, planned for and responded to on wards, and staff experiences and perceptions of this process.

  • Triangulation of the findings from WPs 1 and 2 to examine the relationship between approaches to aggression management and staff communication, exploring the similarities and differences within and between wards.

  • Ethics and dissemination

    Ethical approval for sites in England has been granted by the Wales Research Ethics Committee 3, REF 22/WA/0066. Findings will be disseminated through peer-reviewed journals, scientific conferences and service user and clinical networks.

    Association between ABO blood group and blood component transfusion requirements in dengue infection: a retrospective study from a tertiary hospital in Kerala, India

    Por: Cherupanakkal · C. · Jacob · A. · Olickal · J. J. · Varughese · J. E. · Thampi · A. · Jacob · A. A. · Mathew · R. · Jayaprasad · G. · Varghese · J. E.
    Objective

    Platelet and fresh frozen plasma (FFP) transfusions are routinely employed in the management of severe dengue. Previous research has indicated a potential link between ABO blood groups and susceptibility to dengue, with evidence suggesting that mosquito vector feeding preferences may be influenced by host blood type. These factors could potentially impact transfusion demands during outbreaks. This retrospective study aimed to investigate the relationship between ABO blood groups and transfusion requirements in patients with dengue.

    Design

    Retrospective study.

    Setting

    The study was conducted at a tertiary care hospital in Kerala.

    Methods

    Clinical and laboratory data were reviewed for 199 patients confirmed with dengue who received blood component transfusions and compared with two control groups: 200 randomly selected patients with dengue who did not require transfusions and 200 patients without dengue who required transfusions, over a period spanning January 2015 to March 2023.

    Results

    Among transfused dengue cases, blood groups O (41.71%), A (28.14%) and B (23.12%) were most prevalent; however, no statistically significant association was observed between ABO blood group and transfusion requirement. Furthermore, the total volumes of FFP and platelet transfusions did not differ significantly across ABO groups among patients with dengue. Notably, platelet transfusions were significantly more frequent in dengue cases (92.0%) compared with transfused patients without dengue (35.5%), whereas FFP transfusions were more common in non-dengue transfused cases (84.5%) than in patients with dengue (44.7%). Patients with dengue also received significantly higher mean volumes of both FFP and platelets.

    Conclusion

    Despite earlier reports linking ABO blood types to dengue susceptibility, this study found no significant association with transfusion requirements, warranting confirmation through larger multicentre studies.

    Comparative effectiveness of take-home dosing schedules for opioid agonist treatment in British Columbia, Canada: a target trial emulation protocol using a population-based observational study

    Por: Kurz · M. · Guerra-Alejos · B. C. · Hossain · M. B. · Min · J. E. · Yan · R. · Bruneau · J. · Catherine · N. L. A. · Greenland · S. · Gustafson · P. · Hedden · L. · Karim · E. · McCandless · L. · Nolan · S. · Platt · R. W. · Bach · P. · Seaman · S. · Siebert · U. · Socias · M. E. · Nosyk
    Introduction

    The introduction of fentanyl and its analogues in the illicit drug supply has prompted greater emphasis on refining clinical treatment protocols to ensure sustained retention in opioid agonist treatment (OAT). Take-home dosing may lessen the treatment burden on clients and thus reduce the risk of treatment discontinuation. The evidence base supporting the use of take-home dosing, including the optimal duration of dispensations, is, however, limited. The objective of this study is to determine the comparative effectiveness of alternative take-home dosing schedules, as observed in clinical practice in British Columbia, Canada from 2010 to 2022.

    Methods and analysis

    We propose to emulate a target trial with a population-level retrospective study of individuals initiating methadone or buprenorphine/naloxone between 1 January 2010 and 31 December 2022 who are 18 years of age or older and not currently incarcerated or pregnant with no history of cancer or palliative care. Our study will draw on nine linked health administrative databases from British Columbia and will evaluate take-home doses of 2–5 days, 6 days or >6 days compared with continuous daily dosing. The primary outcomes include OAT discontinuation and all-cause mortality on treatment. A causal per-protocol analysis is proposed with longitudinal matching and inverse probability of censoring weighting approaches to adjust for time-fixed and time-varying confounding. A range of sensitivity analyses will be executed to determine the robustness of results.

    Ethics and dissemination

    The protocol, cohort creation and analysis plan have been classified and approved as a quality improvement initiative by Providence Health Care Research Ethics Board and the Simon Fraser University Office of Research Ethics. Results will be disseminated and shared with local advocacy groups and decision-makers, developers of national and international clinical guidelines, presented at national and international conferences and published in peer-reviewed journals electronically and in print.

    Evaluating care pathways in Alzheimers disease: a qualitative interview study with GPs in England

    Por: Carter · M. · Butterworth · J. E. · Fox · C. · Allan · L.
    Aim

    To understand general practitioners’ (GPs’) experience of existing care pathways for people with moderate-severe Alzheimer’s Disease (AD) and explore their attitudes towards potential modifications to these pathways.

    Design

    Secondary thematic analysis of qualitative interviews, originally conducted with GPs to explore prescribing of memantine in general practice. The theoretical domains framework was used to structure the data.

    Setting

    The study participants were recruited via an online survey completed by GPs across England.

    Participants

    Semi-structured, qualitative interviews were conducted with thirteen male and ten female GPs from a range of general practices in England.

    Primary outcome

    Insights into GPs’ views and experiences regarding existing and possible care pathways for individuals with moderate to severe AD.

    Results

    Gaps in GPs’ current levels of knowledge and skill in respect of caring for patients with moderate-to-severe AD affect their confidence and ability to identify opportunities for additional treatments. While GPs emphasise their role as providers of holistic care, features of the current healthcare context, including a lack of additional funding, inhibit their willingness to assume additional responsibilities as part of a revised pathway.

    Conclusion

    A considerable knowledge, skills and confidence gap must be addressed to support the implementation of new care pathways that include revised responsibilities for GPs. GPs need appropriate support and resources to manage their patients’ changing needs and to provide the best possible pharmacological management as the disease develops.

    Finding the optimal regimen for Mycobacteroides abscessus treatment (FORMaT) in people with Mycobacteroides abscessus pulmonary disease: a multicentre, randomised, multi-arm, adaptive platform trial

    Por: Jong · T. · Baird · T. · Barr · H. L. · Bell · S. · Bigirumurame · T. · Brady · K. · Burke · A. · Byrnes · J. · Caudri · D. · Clark · J. E. · Coin · L. J. M. · Goh · F. · Grimwood · K. · Hicks · D. · Jayawardana · K. · Joshi · S. · Lee · K. · Qvist · T. · Reid · D. · Rice · M. · Roberts · J. A.
    Introduction

    Mycobacteroides abscessus (MABS) is within the non-tuberculous mycobacteria family. It inhabits soil and water, exhibits multi-antibiotic resistance and causes opportunistic lung infections, which may progress to symptomatic MABS-pulmonary disease (MABS-PD) associated with substantial morbidity, increased healthcare utilisation, impaired quality of life and increased mortality. Treatment regimens for MABS-PD are highly variable, not evidence-based and involve complex, expensive drug combinations administered for prolonged periods (>12 months) with frequent adverse effects and treatment failure. There is an urgent need for safe, efficacious and cost-effective MABS-PD therapy. Here, we describe the Master Protocol for the Finding the Optimal Regimen for Mycobacteroides abscessus Treatment (FORMaT) trial. FORMaT aims to determine the most effective and best tolerated treatment for MABS-PD as defined by MABS clearance from respiratory samples with good treatment tolerance.

    Methods and analysis

    FORMaT is an international multicentre, adaptive platform trial evaluating treatment combinations for MABS-PD. Participants are randomised multiple times during the trial, with assessment of the primary outcome of clearance of MABS infection with good treatment tolerance. Initially, therapies recommended in international consensus guidelines are being tested. Data obtained will eliminate therapies lacking efficacy or causing unacceptable toxicity. Novel treatments can then be added and tested against previously determined optimal approaches, leading in an iterative fashion to improved microbiological clearance and health outcomes. In parallel, an Observational cohort and several integrated and discovery studies are embedded in FORMaT to identify biomarkers of MABS-PD and MABS clearance, clinical and radiographic treatment response, drug pharmacokinetics and Mycobacteroides genomics and resistome.

    Ethics and dissemination

    The FORMaT Master Protocol and related documents are approved by regulatory authorities in each participating jurisdiction and/or site. Results will be published in peer-reviewed journals and presented at scientific meetings. De-identified, aggregated data will be shared on an approved online platform.

    Trial registration numbers

    NCT04310930, ANZCTR12618001831279, 2020-000050-10, ISRCTN67303903.

    Developing an approach to enhance recruitment for a cluster-randomised implementation trial: leveraging deliberative participation and credible messengers

    Por: Vaughn · V. M. · Horowitz · J. · Gandhi · T. · Neetz · R. A. · Petty · L. · Hersh · A. · Lindenauer · P. · Bernstein · S. J. · Flanders · S. A. · Harrison · J. D. · Smith · J. D. · White · A. T. · Szymczak · J. E.
    Objectives

    To evaluate an innovative approach to recruit 40 hospitals to a cluster randomised controlled trial (RCT) to improve discharge antibiotic prescribing.

    Design

    This study describes the design, implementation and impact of a theory-informed recruitment approach for hospitals participating in the Reducing Overuse of Antibiotics at Discharge (ROAD) Home trial.

    Setting

    An inperson meeting of a quality improvement collaborative of acute care hospitals in the state of Michigan.

    Participants

    Representatives from acute care hospitals that are part of the Michigan Hospital Medicine Safety Consortium.

    Interventions

    Small group recruitment sessions that combined deliberative participation and credible messengers to recruit hospitals to participate in a cluster RCT on a single date (1 November 2023).

    Primary and secondary outcomes

    The primary outcome was the number of hospitals which agreed to participate in the trial. We also assessed participant feedback, effectiveness of recruitment methods and resources required for implementation of this approach.

    Results

    We recruited 51 (74%) of 69 eligible hospitals. Survey participants reported: sessions made clear the purpose of the trial (94%, 64/68) and time commitment required (87%, 59/68); agreed deliberative participation was helpful (82%, 56/68) and were ‘very satisfied’ with the session (82%, 56/68). Investigators largely reported credible messengers were a positive influence, though this varied across sessions. Hospital recruitment was time intensive, taking 179.5 total person hours. The recruitment process involved 3 months of preparation for the sessions and 2 months of follow-up prior to closing recruitment.

    Conclusions

    We demonstrated the feasibility and impact of a novel approach to recruit hospitals from an existing collaborative to a cluster RCT using the principles of deliberative participation and credible messengers. While the approach was time-consuming, we achieved success at over-recruiting hospitals in a relatively short period of time. Strategies presented here may assist future trial organisers in implementing hospital-based cluster RCTs.

    Trial registration number

    The ROAD Home trial is registered on Clinical.Trials.gov (NCT06106204).

    LDL-C achievement in patients with coronary artery disease: a study protocol for the EDHIPO-MARCA retrospective registry

    Por: Cordoba-Melo · B. D. · Arango-Ibanez · J. P. · Posso-Marin · S. · Ruiz · A. J. · Molina · D. I. · Gomez-Mesa · J. E.
    Introduction

    Elevated lipid profiles increase the risk of atherosclerotic cardiovascular disease (ASCVD), a leading cause of mortality worldwide. Despite the availability of lipid-lowering therapy (LLT), adherence to therapy and achievement of Low-Density Lipoprotein Cholesterol (LDL-C) target levels remain suboptimal. Coronary artery disease (CAD) presents substantial public health challenges, with LDL-C goal attainment rates reported to be between 30.0% and 54.0%. The EDHIPO MARCA (Evaluación De adherencia a la terapia HIPOlipemiante en pacientes de Muy Alto Riesgo CArdiovascular) study aims to evaluate LDL-C target achievement among Colombian patients with CAD.

    Methods and analysis

    This is a retrospective and multicentre study aiming to evaluate LDL-C target achievement within 12 months of coronary angiography across multiple Colombian institutions. Data will be retrospectively extracted from medical records corresponding to the years 2011, 2012, 2016, 2017, 2021 and 2022, which were selected to correspond with the European Society of Cardiology/European Atherosclerosis Society guideline updates. Inclusion criteria included patients ≥18 years old with confirmed CAD and LDL-C reports recorded during outpatient follow-up. The study will evaluate a minimum sample size of 5000 patients, with data collected through medical records and managed using the REDCap platform. Statistical analyses will be conducted to assess LDL-C target achievement, associated factors and temporal trends using mixed-effects models. Uncertainty will also be explored through sensitivity analysis. The EDHIPO MARCA study will provide key insights into LDL-C target achievement in Colombia, contributing to both regional and global CAD management. Its findings will be used to help shape public health policies and serve as a foundation for future prospective research and interventions aimed at mitigating the burden of cardiovascular disease.

    Ethics and dissemination

    This study was approved by the Comité de Ética en Investigación Biomédica of Fundación Valle del Lili, the coordinating institution and creator of the study protocol. Each participating centre will obtain approval from its local ethics committee prior to data collection. Data will be collected in a de-identified manner, ensuring confidentiality. In accordance with Colombian Resolution 8430, this study is classified as 'no-risk', and informed consent was not required. The findings will be disseminated through scientific events and published in international peer-reviewed journals to contribute to cardiovascular disease management and public health policies.

    Comparative effectiveness of alternative initial doses of opioid agonist treatment for individuals with opioid use disorder: a protocol for a retrospective population-based study using target trial emulation in British Columbia, Canada

    Por: Yan · R. · Hossain · M. B. · Min · J. E. · Kurz · M. · Smith · K. · Piske · M. · Seaman · S. · Bach · P. · Karim · E. · Platt · R. W. · Siebert · U. · Socias · M. E. · Xie · H. · Nosyk · B.
    Introduction

    Selecting an optimal initial dosage of opioid agonist treatment (OAT) balances effectiveness and safety, as initial doses that are too low may be insufficient, potentially prompting clients to seek unregulated drugs to alleviate withdrawal symptoms, which may increase the likelihood of treatment discontinuation. Conversely, initial doses that are too high carry a risk of overdose. As opioid tolerance levels have risen in the fentanyl era, linked population-level data capturing initial doses in the real world provide a valuable opportunity to refine existing guidance on optimal OAT dosing at treatment initiation. Our objective is to determine the comparative effectiveness of alternative initial doses of methadone, buprenorphine-naloxone and slow-release oral morphine at OAT initiation, as observed in clinical practice in British Columbia (BC), Canada.

    Methods and analysis

    We propose a population-level retrospective observational study with a linkage of nine provincial health administrative databases in BC, Canada (1 January 2010 to 31 December 2022). Our study includes two time-to-event primary outcomes: OAT discontinuation and all-cause mortality during follow-up. We propose ‘initiator’ target trial analyses for each medication using both propensity score weighting and instrumental variable analyses to compare the effect of different initial OAT doses on the hazard of time-to-OAT discontinuation and all-cause mortality. A range of sensitivity analyses will be used to assess the robustness of the results.

    Ethics and dissemination

    The protocol, cohort creation and analysis plan have been classified and approved as a quality improvement initiative by Providence Health Care Research Ethics Board and the Simon Fraser University Office of Research Ethics. Results will be disseminated to local advocacy groups and decision-makers, national and international clinical guideline developers, presented at international conferences and published in peer-reviewed journals electronically and in print.

    Considering the full care pathway in regional variation in paediatric otitis media treatment in the Netherlands: an observational study

    Por: de Weerdt · V. · van Dijk · C. · Burgers · J. · Gaspar · K. · Hek · K. · Hemler · R. J. · Repping · S. · Verheij · R. A. · Willems · H. C. · van der Hijden · E. J. E. · Koolman · X.
    Objective

    Ventilation tube insertion for paediatric otitis media (POM), including acute otitis media (AOM) and otitis media with effusion (OME), has been signalled in the past for potential unwarranted treatment variation. Quality improvement initiatives, like Audit & Feedback (A&F), often ignore the care pathway when identifying such variation, possibly overestimating variation at a specific care step. To gain more insight into the effect of prior care steps, this study examined (1) the degree of regional variation in each step of the care pathway (general practitioner (GP) contacts, referrals and surgeries) and (2) investigated the effect of adjusting for prior care steps.

    Design

    Observational study using general practice electronic health record data linked to specialist claims data.

    Participants

    272 790 children ≤12 years with and without POM registered in 320 GP practices between 2017 and 2018.

    Primary and secondary outcomes

    Using multilevel logistic regression, the degree of regional variation in each step of the POM care pathway was assessed by calculating the coefficient of variation (CV).

    The effect of adjusting for prior care steps was determined by estimating correlations between subsequent care steps and analysing the impact on the CV.

    Results

    Regional variation in POM treatment was larger in each subsequent step in the care pathway (CV POM GP contacts 0.110; referral 0.179; surgery 0.239). In regions with a higher proportion of children with frequent AOM/persistent OME, referral rates were higher (POM: OR: 1.06; 95% CI: 1.02 to 1.11) and surgical rates were higher (for OME only: OR: 1.08; 95% CI: 1.02 to 1.15). Regional variation in referrals and surgery decreased after adjusting for the regional frequent AOM/persistent OME rate (CV referrals POM 0.103 vs 0.128; CV surgery OME 0.047 vs 0.059).

    Conclusions

    Regional variation is observed in GP contact rates for POM and is larger in referrals and surgeries. Adjusting for the proportion of frequent AOM/persistent OME significantly reduces regional variation in POM treatment. Future A&F should adjust for prior care processes and develop tailored interventions for quality improvement.

    Perceived satisfaction of prenatal care among women without social security: comparative qualitative analysis between individual and group care models in Mexico

    Por: Santivanez Salazar · M. R. · Alcalde-Rabanal · J. E. · Heredia-Pi · I. B. · Darney · B. · Campero · L.
    Background

    The inadequate handling of obstetrical complications may be attributed to the suboptimal quality of prenatal care (PC) and a lack of trust in healthcare provider (HP) among pregnant women.

    Objective

    This study explores the perceptions of satisfaction among women without social security regarding the PC provided by public health services, and compares the dimensions of satisfaction between those who received group prenatal care (GPC) and those who received individual prenatal care (IPC), as well as to identify the dimensions of satisfaction most valued by women to support the inclusion of said dimensions in primary health guidelines.

    Design

    We performed a qualitative analysis to explore women’s satisfaction perception regarding PC. Satisfaction was explored using the following dimensions: women-HP relationship, educational support, opportunity of PC, emotional support and perception of clinical procedures.

    Setting

    The study was conducted between 2015 and 2018 across eight primary health facilities, from which four implemented IPC and four implemented GPC. Semi-structured interviews were applied: 28 for women with IPC and 18 for women with GPC. The sample size was defined by theoretical saturation. Content analysis was performed using a combination of deductive–inductive process into dimensions and attributes. To analyse the relationship among dimensions and attributes, we performed onto semiotic networks. ATLAS.ti was used to analyse the information.

    Participants

    Women without social security who received PC care in public health facilities.

    Results

    Women who received GPC reported higher satisfaction than those who received IPC. In GPC, the most valued dimensions were (1) women-HP relationship, particularly the continuity of care delivered by the same HP and (2) the trust in that same provider. According to semiotic networks, these dimensions showed interconnections with each other, but also connected with attributes of other dimensions. Therefore, they have the potential to enhance trust, communication, the effectiveness of educational activities and emotional support.

    Conclusion

    A holistic approach to GPC is essential for ensuring a positive prenatal experience. However, a hybrid model that incorporates elements of both IPC can further enhance overall satisfaction among women. Consistency in care, particularly by providing services in public health facilities with the same HP, should be a fundamental strategy in PC, as it can significantly improve women’s satisfaction.

    Investigating discrepancies in perceptions regarding the provision of hospital rest and relaxation spaces in Scotland during the COVID-19 pandemic and beyond: a qualitative study

    Por: Walker · K. A. · Cunningham · K. B. · Ferguson · J. · Gibson Smith · K. · Scanlan · G. M. · Cecil · J. E. · Gordon · L. · Laidlaw · A. · Pope · L. M. · Johnston · P. · Aitken · G.
    Objectives

    To investigate discrepancies in perceptions regarding the accessibility and availability of rest and relaxation (R&R) spaces between hospital doctors in Scotland and NHS Scotland regional health boards (HBs), with the intention of informing best practices for organisational policy on the provision of R&R spaces both now and in the future.

    Design

    A qualitative study, through an inhabited institutionalism (II) lens, of semi-structured interviews of hospital doctors across the career continuum in Scotland and all NHS regional HBs in Scotland providing written information relating to R&R space provision.

    Setting

    NHS Scotland during the COVID-19 pandemic and beyond.

    Participants

    Hospital doctors (n=30) who had participated in a larger qualitative study and provided specific insights on R&R spaces. All NHS Scotland regional HBs (n=14).

    Results

    Although HBs reported the provision of R&R spaces, numerous doctors reported R&R spaces had been removed, relocated or were inaccessible. Furthermore, limited awareness of their availability attributed to inadequate communication, compounded the issue. This divergence between institutional reporting and front-line experience can be interpreted through the lens of II, which posits that institutional polices are often interpreted and implemented differently.

    Conclusions

    This study emphasises how crucial R&R spaces are to promoting doctors’ well-being especially during the time of high stress. HBs must not only guarantee the accessibility and physical availability of R&R spaces but also enhance their communication regarding the provision.

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