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Lack of association between the brain penetrance of calcium channel blockers and the incidence of neuropsychiatric outcomes: a retrospective, multidatabase cohort study

Por: Kern · D. M. · Bohn · J. · Maher · M. P. · Dymshyts · D. · Shoaibi · A.
Objective

To use best practices in pharmacoepidemiology to assess the association between new use of brain-penetrant calcium channel blockers (BP-CCBs) compared with use of non-brain-penetrant CCBs (NP-CCBs) and the incidence of neuropsychiatric outcomes.

Design

Retrospective comparative cohort study.

Setting

Secondary data from nine claims and electronic health record databases from across the globe were used.

Participants

First use of a CCB was the index date. There were 1.2 million BP-CCB patients and 9.3 million NP-CCB patients identified across all databases, with 881 758 matched in each group.

Interventions

Patients were categorised as either initiating BP-CCBs or NP-CCBs. On-treatment and intention-to-treat analyses were conducted. Large-scale propensity models were used to match cohorts and control for observed confounding. Cox models were used to analyse the time to incident neuropsychiatric disorders. Negative control outcomes were used to calibrate estimates, CIs and p values to account for residual confounding. Diagnostics were used to assess the validity of the analysis.

Primary and secondary outcome measures

The time to first diagnosis of schizophrenia, schizoaffective disorder, major depressive disorder (MDD) and bipolar disorder was assessed independently. HRs compared the BP-CCB group to the NP-CCB group.

Results

For the outcome of incident MDD in the intention-to-treat design, the meta-analytic HR (95% CI) was 1.02 (0.97, 1.08). Meta-analytic HRs for bipolar disorder (1.04 (0.96, 1.13)), schizophrenia (1.05 (0.94, 1.18)) and schizoaffective disorder (1.04 (0.87, 1.23)) showed similar null effects. The on-treatment analysis was largely consistent: MDD (1.01 (0.96, 1.06)), bipolar (1.05 (0.86, 1.27)), schizophrenia (1.09 (0.87, 1.38)) and schizoaffective (1.00 (0.71, 1.40)).

Conclusions

There was no evidence of an association with any of the neuropsychiatric conditions of interest between use of BP-CCB and NP-CCB. This does not rule out the potential beneficial effect of CCB formulations and doses targeted specifically for the brain rather than the cardiovascular system.

Prevalence of and factors associated with pain-related disabilities among First Nations people living off-reserve in Canada in 2017: a secondary analysis of data from the 2017 Aboriginal Peoples Survey

Por: DeSouza · A. · Cancelliere · C. · Hogg-Johnson · S. · Sheppard · A. J. · Taylor · D. · Ward · J. L. · Radyk · R. · Maher · J. · Garner · J. · Lynds · R. · Cote · P.
Objectives

To determine the prevalence and factors associated with pain-related disabilities among First Nations people living off-reserve in Canada in 2017.

Design and setting

Secondary analysis of the 2017 Aboriginal Peoples Survey, a cross-sectional survey of individuals living in private dwellings throughout Canada.

Participants

First Nations people living off-reserve aged 15 years and older (n=9115; weighted n=482 066).

Outcome measure

Pain-related disabilities, defined as pain-related activity limitations lasting ≥6 months.

Results

Overall, 22.1% (95% CI 20.9% to 23.4%) of First Nations people living off-reserve reported pain-related disabilities. Prevalence was higher among females (26.1%; 95% CI (24.3% to 28.0%)), increased with age (34.3%; 95% CI (30.3% to 38.5%) among those 45 to 54 years) and was similar across geographic areas (ranging from 21.0%; 95% CI (18.3% to 23.9%) to 22.5%; 95% CI (20.8% to 24.2%)). Pain-related disabilities increased with the number of coexisting disabilities (96.2%; 95% CI (94.3% to 97.5%) among those with >3 disabilities) and was highest among those reporting physical disabilities (ranging from 88.2%; 95% CI (85.6% to 90.4%) for those with mobility disabilities to 91.0%; 95% CI (88.6% to 92.9%) for those with disability related to flexibility). Regression models suggested that individuals with unmet basic needs, housing dissatisfaction, unmet healthcare needs, a history of mental health consultations, part-time or no employment, chronic conditions, residential school attendance or a low sense of belonging were more likely to report pain-related disabilities.

Conclusions

Pain-related disabilities are common among First Nations people living off-reserve, and their aetiology may be multifactorial. Continued collaboration with Indigenous partners is required to contextualise findings and to inform culturally responsive clinical and rehabilitation strategies.

Perceptions of best practice, pain science and structure-focused education for rotator cuff-related shoulder pain: a content analysis of qualitative data from a randomised experiment

Por: Zhang · Z. · Ferreira · G. E. · Muller · R. · Sousa · F. · Malliaras · P. · West · C. A. · OKeeffe · M. · Maher · C. · Zadro · J.
Objectives

To explore how people perceive different forms of education for rotator cuff-related shoulder pain in terms of words or feelings evoked by the education and treatments they feel are needed.

Setting

We performed a content analysis of qualitative data collected in a randomised experiment.

Participants

2237 participants with rotator cuff-related shoulder pain were randomly assigned to receive three forms of education: best practice education, best practice education plus pain science messages and structure-focused education.

Primary and secondary outcomes

After receiving the education, participants answered two questions regarding (1) words or feelings evoked by the education and (2) treatments they felt were needed.

Results

2232 responses for each question were analysed (99.7% response rate). Participants who received best practice education more frequently expressed feelings of unhappiness/frustration. The addition of pain science messages to best practice education resulted in slightly more emotional responses and a greater sense of being validated or cared for. In contrast, participants who received structure-focused education more frequently expressed trust in the clinician’s expertise and the need for medication, activity modification, rest, diagnostic imaging, injections and surgery. These participants also less frequently considered exercise as a viable treatment option.

Conclusion

Participants with rotator cuff-related shoulder pain expressed generally similar emotional responses across groups, with small differences in treatment preferences favouring self-management in the best practice education groups compared with those who received structure-focused education. Those in the best practice education also less frequently reported needing potentially unnecessary treatments (eg, imaging, injections and surgery).

Trial registration number

Australia New Zealand Clinical Trials Registry (ACTRN12623000197639).

Efficacy of YOga in people with chronic non-specific low BACK pain and poor PROgnosis (YOBACK-PRO): protocol for a randomised clinical trial

Por: Nunes · S. M. · Rizzo · R. R. · Franco · M. R. · Ferreira · F. R. · Barros · L. J. G. · Maciel · I. T. · Santos · R. L. · Nascimento · R. R. · Couto · A. J. · Quaresma · L. S. · Fontes · R. M. · Ferreira · E. M. R. · Maher · C. G. · McAuley · J. H. · Pinto · R. Z.
Introduction

Yoga has been shown to improve pain and function compared with no exercise in people with chronic low back pain (LBP), but treatment effects are small. Given that yoga is a mind–body intervention that addresses physical as well as psychological factors, it may be more effective for patients with chronic LBP who are at high risk of poor prognosis. The study aims to investigate the efficacy of a 12-week yoga programme combined with education in reducing pain and disability for individuals with chronic LBP at high risk of poor prognosis at short (12 weeks) and intermediate (24 weeks) terms, compared with a control group receiving education only.

Methods and analysis

A randomised controlled trial will include 110 adults with chronic non-specific LBP reporting an average pain intensity of 3 points or more on a 0–10 scale over the past week and classified as high risk of poor prognosis (ie, scoring 50 points or above) on the Orebro Musculoskeletal Pain Questionnaire short-form. Participants in the control group will receive an educational booklet and attend three face-to-face lectures over a 3-month period. In the intervention group, in addition to the booklet and lectures, participants will attend group yoga sessions twice a week for 12 weeks, totalling 24 yoga sessions. The primary outcome is disability assessed at 12 weeks, measured using the Roland-Morris Disability Questionnaire.

Ethics and dissemination

The study was approved by the Human Research Ethics Committee of Universidade Federal de Minas Gerais (Protocol number CAAE: 57028022.0.0000.5149). Findings will be disseminated to trial participants, clinicians and the broader public and scientific community.

Trial registration number

NCT05953155.

Exploring the Development of Early Career Nurses: Insights 4 Years After Graduation

ABSTRACT

Aim

To explore how Early Career Nurses perceive their preparedness for nursing practice, the teaching and learning experiences, and the role of professional experience placements on their professional development.

Design

A qualitative study using a hermeneutic phenomenological approach.

Method

The study involved 25 Early Career Nurses who participated in follow-up interviews 4 years post-graduation in Australia between 2022 and 2024. Data were collected through semi-structured interviews and analysed using Thematic Analysis.

Results

Three key themes emerged: gaps in preparedness, the power of being embedded and too many balls to juggle. Participants indicated a mixed sense of preparedness with significant gaps in clinical skills. They emphasised the critical role of professional experience placements and mentorship to bridge the gap between theoretical knowledge and practical application. Placements and mentorship opportunities were considered essential to develop confidence and competence for effective nursing practice.

Conclusion

The study highlights the necessity for nursing curricula to address significant gaps in clinical skills, particularly in surgical and emergency nursing. By incorporating more simulation-based learning, interprofessional education and robust mentorship programmes, nursing education can better prepare graduates for the realities of clinical practice. These enhancements will help ease the transition from academic training to clinical practice, reducing reality shock and fostering a more confident, competent and resilient nursing workforce.

Implications for the Profession

Nursing education must integrate more simulation-based learning and interprofessional education opportunities, which are crucial for bridging the gap between theoretical knowledge and practical application, ensuring that graduates are adequately prepared for the demands of clinical practice. Additionally, professional experience placements and mentorship should be prioritised to develop the confidence and competence for effective nursing practice.

Reporting Method

This study adheres to the Consolidated criteria for reporting qualitative research guidelines.

Patient or Public Contribution

No Patient or Public Contribution.

Implementation of an Australian helpline for low back pain: protocol of a type 2 hybrid effectiveness-implementation trial

Por: Zouch · J. · Roberts · K. · Bauman · A. · Jentz · H. · Ho · E. K. · Hodges · P. · Maher · C. · Baysari · M. T. · Thompson · J. · Calder · R. · Luscombe · G. · Ceprnja · D. · Maka · K. · Tian · Y. · Chen · Y. · Chen · M. · Mork · P. J. · Li · Q. · Wise · S. · Gilbert · M. · Hall · M. · Ferreira
Introduction

Low back pain (LBP) is the leading contributor to disability globally. It has a substantial impact on the lives of those who experience it, and places considerable economic burden on healthcare systems. Despite these impacts, and the consistency of guideline recommendations, many individuals do not receive recommended LBP management. Structural barriers to accessing timely, evidence-based care, as well as public uncertainty about where to seek appropriate management, can influence the care individuals receive. Telephone and digitally based helplines assist to overcome many traditional barriers to accessing care and offer a scalable platform to improve the delivery of guideline recommended management for LBP. However, uptake of such services can be limited without targeted promotion and patient-centred design. This project aims to codesign, implement and evaluate an upgraded component of an existing Australian helpline service, tailored for people with back pain and supported by a media awareness campaign. This protocol outlines the codesign process, implementation and planned evaluation of the helpline.

Methods and analyses

This protocol uses three complementary frameworks—an iterative codesign process, the Practical Robust Implementation Sustainability Model, and the Reach, Effectiveness, Adoption, Implementation and Maintenance framework—to guide the codesign and development, implementation and evaluation of an upgraded helpline for people with LBP. The codesign process involves key stakeholders, including consumers and clinicians, to inform the development and implementation of both the upgraded helpline service and the media campaign to raise awareness and uptake of the helpline. Data sources will include a pre–post cohort of helpline service users, routinely collected service data (eg, monthly call rate) and health system data to evaluate the broader population level impact (eg, rates of emergency department presentations for LBP in the Australian region targeted by the media campaign). Implementation evaluation will include Reach, Effectiveness, Adoption, Implementation and Maintenance as well as internal and external environmental factors that influence the success of these outcome measures.

Ethics and dissemination

The project was approved by the University of Sydney’s Human Research Ethics Committee (HE001081). This project involves collaboration with consumers, clinicians and other stakeholders to interpret, translate and disseminate research findings to relevant audiences.

Kidney failure risk equation to predict kidney transplant failure in individuals with an eGFR<30 mL/min/1.73 m2: a UK Renal Registry external validation and recalibration study

Por: Masoud · S. · Bello · A. · Santhakumaran · S. · Casula · A. · Maher · F. · Benoy-Deeney · F. · Medcalf · J. · Major · R. · Nitsch · D.
Objectives

To externally validate and subsequently repurpose/recalibrate the easily accessible kidney failure risk equation (KFRE) for a prevalent transplant population with an estimated glomerular filtration rate (eGFR)

Design

Retrospective cohort study using UK Renal Registry data.

Setting

68 adult UK kidney centres.

Participants

4092 patients with grafts at least 2 years old and eGFR2 from 2009 to 2018.

Primary outcome measure

Death-censored allograft failure at 2 years, defined as dialysis initiation, re-transplantation or, in the absence of the former two, the recorded date of transplant failure.

Prognostic model validation

The KFRE was calculated at baseline using the 2-year, 8-variable non-North American KFRE, and performance was assessed using Harrell’s C-statistic and calibration plots. The model was recalibrated using Cox Regression (2009–2013 cohort) and temporally validated using the 2014–2018 cohort. Clinical utility was assessed using decision-curve analysis, estimating per-100-patient gains in timely planning and reductions in unnecessary interventions compared with eGFR triggers.

Results

The original KFRE had excellent discrimination but was miscalibrated, underpredicting graft failure. Temporal validation demonstrated that the performance of the recalibrated KFRE could be maintained across time periods (Harrell’s C-index of 0.81 (95% CI 0.80 to 0.83); O/E (Observed/Expected events) ratio 1.00 (95% CI 0.93 to 1.07). It identified 9/100 more patients for timely intervention and 13/100 more for whom intervention could be delayed compared with a late clinical trigger of an eGFR2.

Conclusions

While there are other prognostic models, this is the first study to focus on the understudied and clinically important cohort of patients with an eGFR

Evaluating the scale-up of the Play Active programme for childrens physical activity in early childhood education and care services: a national type III hybrid effectiveness-implementation trial protocol

Por: Christian · H. · Maher · C. · Trost · S. G. · Schipperijn · J. · Murray · K. · Li · I. · Nathan · A. · Papageorgiou · A. · Mclaughlin · M. · Bauman · A.
Introduction

Physical activity is crucial for young children’s health and development. Many young children do not meet the recommended 3 hours of daily physical activity, including 60 min of energetic play. Early childhood education and care (ECEC/childcare) is a key setting to intervene to improve children’s physical activity. The Play Active programme is a scalable evidence-informed ECEC-specific physical activity policy intervention with implementation support strategies to improve educators’ physical activity-related practices.

Methods and analysis

This hybrid type III effectiveness-implementation trial will use a quasi-experimental repeated measures design to assess the real-world effectiveness of Play Active’s scalable implementation support strategies in helping ECEC services adopt the practices included in the Play Active policy. Secondary aims will examine changes in educator-reported and device-measured children’s physical activity; assess the sustainability of the programme; identify effective dissemination strategies; assess cost-effectiveness; and involve comprehensive process evaluation. All ECEC services in Western Australia (n=776), Queensland (n=1744) and South Australia (n=445) will be invited to participate. Data will be collected at baseline, 6, 12, 18, 24 and 30 months.

Ethics and dissemination

Ethics approval has been provided by The University of Western Australia Human Research Ethics Committee (HREC) (2023/ET000187), the University of Queensland HREC (2024/HE000076) and the University of South Australia HREC (206023). This real-world trial of Play Active is vital for understanding its implementation in practice and to generate evidence for further scale-up and roll-out nationally. Key findings will be disseminated to stakeholders, collaborators, policy-makers as well as families and practitioners in the ECEC sector.

Trial registration number

ACTRN12624000406505.

Behaviour change interventions addressing patient antibiotic treatment-seeking behaviour for respiratory tract infections in primary and community care settings: a scoping review

Por: Maher · A. · Roche · K. · Morrissey · E. · Murphy · A. · Sheaf · G. · Ryan · C. · Molloy · G. J.
Objectives

This scoping review aimed to map studies on behaviour change interventions that address antibiotic treatment-seeking behaviour for respiratory tract infections in primary and community care settings.

Design

This review is based on the Joanna Briggs Institute guidelines for scoping reviews, guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews.

Data sources

A literature search in January 2024 and May 2024 was performed across Medline, Embase, CINAHL, PsycINFO, Web of Science Core Collection, Scopus, EThOS and Google Scholar was performed.

Eligibility criteria

Eligible studies described behaviour change interventions in primary and community care settings, published from 2000 onward across all countries.

Data extraction and synthesis

Descriptive data relating to study details and intervention functions were gathered and organised according to the Capability, Opportunity, Motivation and Behaviour change framework in a predeveloped data extraction sheet. Dual data extraction occurred, and inter-rater reliability results are reported (K=0.83).

Results

The scoping review identified 38 eligible studies, which consisted of randomised controlled trials (7/38), cluster randomised controlled trials (6/38), randomised experiments (5/38), cross-sectional studies (5/38), qualitative investigations (5/38) and quasi-experimental designs (4/38). Most interventions focused on educational resources (15/38), digital tools (7/38) and community campaigns (6/38), with fewer targeting decision-making processes (4/38) or psychological drivers of antibiotic-seeking behaviour (3/38). Only one study was conducted in low-income and middle-income countries, and only one separately assessed behaviour change as a measured outcome.

Conclusions

This scoping review highlights a wide range of research methodologies within the topic area. There was some limited evidence of intervention efficacy for antibiotic prescription rates, particularly interventions focused on enhancing knowledge and access to resources. However, more emphasis is needed on standardising outcome measures and evaluating long-term outcomes.

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