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Efficacy of migraine prophylaxis treatments for treatment-naïve patients and those with prior treatment failure: a protocol for systematic review and network meta-analysis of randomised controlled trials

Por: Numthavaj · P. · Anothaisintawee · T. · Attia · J. · McKay · G. · Thakkinstian · A.
Introduction

Migraine headache is a significant health problem affecting patients’ psychological well-being and quality of life. Several network meta-analyses (NMAs) have compared the efficacy of migraine prophylaxis medications. However, some have focused exclusively on oral medications, while others were limited to injectable medications. Moreover, none of these NMAs conducted a stratified analysis between treatment-naïve patients and those with prior treatment failure. Therefore, this systematic review and NMA will compare the efficacy among all treatments for migraine prophylaxis, stratified by the treatment status of patients (ie, treatment-naïve and previous treatment failure).

Methods and analysis

Randomised-controlled trials that included patients with chronic or episodic migraine, assessed the efficacy of oral or injectable treatments for migraine prophylaxis and measured the outcomes as monthly migraine day, monthly headache day, migraine-related disability, health-related quality of life or adverse drug events will be eligible for inclusion in this review. Relevant studies will be searched from Medline, Scopus, the US National Institutes of Health Register, and the World Health Organization International Clinical Trials Registry Platform (WHO-ICTRP) databases since inception through 15 August 2023. Risk of bias assessment will be performed using a revised tool for assessing the risk of bias in randomised trials. Two-stage NMA will be applied to compare relative treatment effects among all treatments of migraine prophylaxis. Surface under the cumulative ranking curve will be applied to estimate and rank the probability to be the best treatment. Consistency assumption will be assessed using a design-by-treatment interaction model. Publication bias will be assessed by comparison-adjusted funnel plot. All analyses will be stratified according to patients’ status (ie, treatment-naïve and prior treatment failure).

Ethics and dissemination

This study is a systematic review protocol collecting data from published literature and does not require approval from an institutional review board. Results from this systematic review will be published in a peer-reviewed journal.

PROSPERO registration number

CRD42020171843.

Understanding and addressing changing administrative workload in primary care in Canada: protocol for a mixed-method study

Por: Lavergne · M. R. · Moravac · C. · Bergin · F. · Buote · R. · Easley · J. · Grudniewicz · A. · Hedden · L. · Leslie · M. · McKay · M. · Marshall · E. G. · Martin-Misener · R. · Mooney · M. · Palmer · E. · Tracey · J.
Introduction

Many Canadians struggle to access the primary care they need while at the same time primary care providers report record levels of stress and overwork. There is an urgent need to understand factors contributing to the gap between a growing per-capita supply of primary care providers and declines in the availability of primary care services. The assumption of responsibility by primary care teams for services previously delivered on an in-patient basis, along with a rise in administrative responsibilities may be factors influencing reduced access to care.

Methods and analysis

In this mixed-methods study, our first objective is to determine how the volume of services requiring primary care coordination has changed over time in the Canadian provinces of Nova Scotia and New Brunswick. We will collect quantitative administrative data to investigate how services have shifted in ways that may impact administrative workload in primary care. Our second objective is to use qualitative interviews with family physicians, nurse practitioners and administrative team members providing primary care to understand how administrative workload has changed over time. We will then identify priority issues and practical response strategies using two deliberative dialogue events convened with primary care providers, clinical and system leaders, and policy-makers.

We will analyse changes in service use data between 2001/2002 and 2021/2022 using annual total counts, rates per capita, rates per primary care provider and per primary care service. We will conduct reflexive thematic analysis to develop themes and to compare and contrast participant responses reflecting differences across disciplines, payment and practice models, and practice settings. Areas of concern and potential solutions raised during interviews will inform deliberative dialogue events.

Ethics and dissemination

We received research ethics approval from Nova Scotia Health (#1028815). Knowledge translation will occur through dialogue events, academic papers and presentations at national and international conferences.

Clinical deterioration as a nurse sensitive indicator in the out‐of‐hospital context: A scoping review

Abstract

Aims

To explore and summarise the literature on the concept of ‘clinical deterioration’ as a nurse-sensitive indicator of quality of care in the out-of-hospital context.

Design

The scoping review adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Review and the JBI best practice guidelines for scoping reviews.

Methods

Studies focusing on clinical deterioration, errors of omission, nurse sensitive indicators and the quality of nursing and midwifery care for all categories of registered, enrolled, or licensed practice nurses and midwives in the out-of-hospital context were included regardless of methodology. Text and opinion papers were also considered. Study protocols were excluded.

Data Sources

Data bases were searched from inception to June 2022 and included CINAHL, PsychINFO, MEDLINE, The Allied and Complementary Medicine Database, EmCare, Maternity and Infant Care Database, Australian Indigenous HealthInfoNet, Informit Health and Society Database, JSTOR, Nursing and Allied Health Database, RURAL, Cochrane Library and Joanna Briggs Institute.

Results

Thirty-four studies were included. Workloads, education and training opportunities, access to technology, home visits, clinical assessments and use of screening tools or guidelines impacted the ability to recognise, relay information and respond to clinical deterioration in the out-of-hospital setting.

Conclusions

Little is known about the work of nurses or midwives in out-of-hospital settings and their recognition, reaction to and relay of information about patient deterioration. The complex and subtle nature of non-acute deterioration creates challenges in defining and subsequently evaluating the role and impact of nurses in these settings.

Implications for the profession and/or patient care

Further research is needed to clarify outcome measures and nurse contribution to the care of the deteriorating patient in the out-of-hospital setting to reduce the rate of avoidable hospitalisation and articulate the contribution of nurses and midwives to patient care.

Impact

What Problem Did the Study Address?

Factors that impact a nurse's ability to recognise, relay information and respond to clinical deterioration in the out-of-hospital setting are not examined to date.

What Were the Main Findings?

A range of factors were identified that impacted a nurse's ability to recognise, relay information and respond to clinical deterioration in the out-of-hospital setting including workloads, education and training opportunities, access to technology, home visits, clinical assessments, use of screening tools or guidelines, and avoidable hospitalisation.

Where and on whom will the research have an impact?

Nurses and nursing management will benefit from understanding the factors that act as barriers and facilitators for effective recognition of, and responding to, a deteriorating patient in the out-of-hospital setting. This in turn will impact patient survival and satisfaction.

Reporting Method

The Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Review guidelines guided this review. The PRISMA-Scr Checklist (Tricco et al., 2018) is included as (supplementary file 1).Data sharing is not applicable to this article as no new data were created or analysed in this study.”

No Patient or Public Contribution

Not required as the Scoping Review used publicly available information.

Supporting adolescents participation in muscle-strengthening physical activity: protocol for the 'Resistance Training for Teens (RT4T) hybrid type III implementation-effectiveness trial

Por: Kelly · H. T. · Smith · J. J. · Verdonschot · A. · Kennedy · S. G. · Scott · J. J. · McKay · H. · Nathan · N. · Sutherland · R. · Morgan · P. J. · Salmon · J. · Penney · D. · Boyer · J. · Lloyd · R. S. · Oldmeadow · C. · Reeves · P. · Pursey · K. · Hua · M. · Longmore · S. · Norman · J. · Vo
Introduction

In Australia, only 22% of male and 8% of female adolescents meet the muscle-strengthening physical activity guidelines, and few school-based interventions support participation in resistance training (RT). After promising findings from our effectiveness trial, we conducted a state-wide dissemination of the ‘Resistance Training for Teens’ (RT4T) intervention from 2015 to 2020. Despite high estimated reach, we found considerable variability in programme delivery and teachers reported numerous barriers to implementation. Supporting schools when they first adopt evidence-based programmes may strengthen programme fidelity, sustainability, and by extension, programme impact. However, the most effective implementation support model for RT4T is unclear.

Objective

To compare the effects of three implementation support models on the reach (primary outcome), dose delivered, fidelity, sustainability, impact and cost of RT4T.

Methods and analysis

We will conduct a hybrid type III implementation–effectiveness trial involving grade 9 and 10 (aged 14–16 years) students from 90 secondary schools in New South Wales (NSW), Australia. Schools will be recruited across one cohort in 2023, stratified by school type, socioeconomic status and location, and randomised in a 1:1:1 ratio to receive one of the following levels of implementation support: (1) ‘low’ (training and resources), (2) ‘moderate’ (training and resources+external support) or ‘high’ (training and resources+external support+equipment). Training includes a teacher workshop related to RT4T programme content (theory and practical sessions) and the related resources. Additional support will be provided by trained project officers from five local health districts. Equipment will consist of a pack of semiportable RT equipment (ie, weighted bars, dumbbells, resistance bands and inverted pull up bar stands) valued at ~$A1000 per school. Study outcomes will be assessed at baseline (T0), 6 months (T1) and 18 months (T2). A range of quantitative (teacher logs, observations and teacher surveys) and qualitative (semistructured interviews with teachers) methods will be used to assess primary (reach) and secondary outcomes (dose delivered, fidelity, sustainability, impact and cost of RT4T). Quantitative analyses will use logistic mixed models for dichotomous outcomes, and ordinal or linear mixed effects regression models for continuous outcomes, with alpha levels set at p

Ethics and dissemination

Ethics approval has been obtained from the University of Newcastle (H-2021-0418), the NSW Department of Education (SERAP:2022215), Hunter New England Human Research Ethics Committee (2023/ETH00052) and the Catholic Schools Office. The design, conduct and reporting will adhere to the Consolidated Standards of Reporting Trials statement, the Standards for Reporting Implementation Studies statement and the Template for Intervention Description and Replication checklist. Findings will be published in open access peer-reviewed journals, key stakeholders will be provided with a detailed report. We will support ongoing dissemination of RT4T in Australian schools via professional learning for teachers.

Trial registration number

ACTRN12622000861752.

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