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AnteayerBMJ Open

Clinical and cost-effectiveness of individualised (early) patient-directed rehabilitation versus standard rehabilitation after surgical repair of the rotator cuff of the shoulder: protocol for a multicentre, randomised controlled trial with integrated Qui

Por: Mazuquin · B. · Moffatt · M. · Realpe · A. · Sherman · R. · Ireland · K. · Connan · Z. · Tildsley · J. · Manca · A. · Gc · V. S. · Foster · N. E. · Rees · J. · Drew · S. · Bateman · M. · Fakis · A. · Farnsworth · M. · Littlewood · C.
Introduction

Despite the high number of operations and surgical advancement, rehabilitation after rotator cuff repair has not progressed for over 20 years. The traditional cautious approach might be contributing to suboptimal outcomes. Our aim is to assess whether individualised (early) patient-directed rehabilitation results in less shoulder pain and disability at 12 weeks after surgical repair of full-thickness tears of the rotator cuff compared with current standard (delayed) rehabilitation.

Methods and analysis

The rehabilitation after rotator cuff repair (RaCeR 2) study is a pragmatic multicentre, open-label, randomised controlled trial with internal pilot phase. It has a parallel group design with 1:1 allocation ratio, full health economic evaluation and quintet recruitment intervention. Adults awaiting arthroscopic surgical repair of a full-thickness tear are eligible to participate. On completion of surgery, 638 participants will be randomised. The intervention (individualised early patient-directed rehabilitation) includes advice to the patient to remove their sling as soon as they feel able, gradually begin using their arm as they feel able and a specific exercise programme. Sling removal and movement is progressed by the patient over time according to agreed goals and within their own pain and tolerance. The comparator (standard rehabilitation) includes advice to the patient to wear the sling for at least 4 weeks and only to remove while eating, washing, dressing or performing specific exercises. Progression is according to specific timeframes rather than as the patient feels able. The primary outcome measure is the Shoulder Pain and Disability Index total score at 12-week postrandomisation. The trial timeline is 56 months in total, from September 2022.

Trial registration number

ISRCTN11499185.

Effect of implementation strategies on the routine provision of antenatal care addressing smoking in pregnancy: study protocol for a non-randomised stepped-wedge cluster controlled trial

Por: Daly · J. B. · Doherty · E. · Tully · B. · Wiggers · J. · Hollis · J. · Licata · M. · Foster · M. · Tzelepis · F. · Lecathelinais · C. · Kingsland · M.
Introduction

Globally, guideline-recommended antenatal care for smoking cessation is not routinely delivered by antenatal care providers. Implementation strategies have been shown to improve the delivery of clinical practices across a variety of clinical services but there is an absence of evidence in applying such strategies to support improvements to antenatal care for smoking cessation in pregnancy. This study aims to determine the effectiveness and cost effectiveness of implementation strategies in increasing the routine provision of recommended antenatal care for smoking cessation in public maternity services.

Methods and analysis

A non-randomised stepped-wedge cluster-controlled trial will be conducted in maternity services across three health sectors in New South Wales, Australia. Implementation strategies including guidelines and procedures, reminders and prompts, leadership support, champions, training and monitoring and feedback will be delivered sequentially to each sector over 4 months. Primary outcome measures will be the proportion of: (1) pregnant women who report receiving a carbon monoxide breath test; (2) smokers or recent quitters who report receiving quit/relapse advice; and (3) smokers who report offer of help to quit smoking (Quitline referral or nicotine replacement therapy). Outcomes will be measured via cross-sectional telephone surveys with a random sample of women who attend antenatal appointments each week. Economic analyses will be undertaken to assess the cost effectiveness of the implementation intervention. Process measures including acceptability, adoption, fidelity and reach will be reported.

Ethics and dissemination

Ethics approval was obtained through the Hunter New England Human Research Ethics Committee (16/11/16/4.07; 16/10/19/5.15) and the Aboriginal Health and Medical Research Council (1236/16). Trial findings will be disseminated to health policy-makers and health services to inform best practice processes for effective guideline implementation. Findings will also be disseminated at scientific conferences and in peer-reviewed journals.

Trial registration number

Australian New Zealand Clinical Trials Registry—ACTRN12622001010785.

Exploring young peoples attitudes to HIV prevention medication (PrEP) in England: a qualitative study

Por: Rathbone · A. · Cartwright · N. · Cummings · L. · Noble · R. · Budaiova · K. · Ashton · M. · Foster · J. · Payne · B. · Duncan · S.
Introduction

Young people aged 18–24 years old are a key demographic target for eliminating HIV transmission globally. Pre-exposure prophylaxis (PrEP), a prevention medication, reduces HIV transmission. Despite good uptake by gay and bisexual men who have sex with men, hesitancy to use PrEP has been observed in other groups, such as young people and people from ethnic minority backgrounds. The aim of this study was to explore young people’s perceptions and attitudes to using PrEP.

Design

A qualitative transcendental phenomenological design was used.

Participants and setting

A convenience sample of 24 young people aged between 18 and 24 years was recruited from England.

Methods

Semistructured interviews and graphical elicitation were used to collect data including questions about current experiences of HIV care, awareness of using PrEP and decision-making about accessing PrEP. Thematic and visual analyses were used to identify findings.

Results

Young people had good levels of knowledge about HIV but poor understanding of using PrEP. In this information vacuum, negative stigma and stereotypes about HIV and homosexuality were transferred to using PrEP, which were reinforced by cultural norms portrayed on social media, television and film—such as an association between using PrEP and being a promiscuous, white, gay male. In addition, young people from ethnic minority communities appeared to have negative attitudes to PrEP use, compared with ethnic majority counterparts. This meant these young people in our study were unable to make decisions about when and how to use PrEP.

Conclusion

Findings indicate an information vacuum for young people regarding PrEP. A strength of the study is that theoretical data saturation was reached. A limitation of the study is participants were largely from Northern England, which has low prevalence of HIV. Further work is required to explore the information needs of young people in relation to PrEP.

Reinforcing informed medication prescription for low back pain in the emergency department (RIME): a controlled interrupted time series implementation study protocol

Por: O'Leary · S. · Heine · J. · Warren · J. · Smyth · T. · Ballard · E. · Mitchell · G. · See · W. · Barlas · P. · Machado · G. C. · Cottrell · M. · Comans · T. · Foster · N. E.
Introduction

Management guidelines for low back pain (LBP) recommend exclusion of serious pathology, followed by simple analgesics, superficial heat therapy, early mobilisation and patient education. An audit in a large metropolitan hospital emergency department (ED) revealed high rates of non-recommended medication prescription for LBP (65% of patients prescribed opioids, 17% prescribed benzodiazepines), high inpatient admission rates (20% of ED LBP patients), delayed patient mobilisation (on average 6 hours) and inadequate patient education (48% of patients). This study aims to improve medication prescription for LBP in this ED by implementing an intervention shown previously to improve guideline-based management of LBP in other Australian EDs.

Methods and analysis

A controlled interrupted time series study will evaluate the intervention in the ED before (24 weeks; 20 March 2023–3 September 2023) and after (24 weeks; 27 November 2024–12 May 2024) implementation (12 weeks; 4 September 2023–26 November 2023), additionally comparing findings with another ED in the same health service. The multicomponent implementation strategy uses a formalised clinical flow chart to support clinical decision-making and aims to change clinician behaviour, through clinician education, provision of alternative treatments, educational resources, audit and feedback, supported by implementation champions. The primary outcome is the percentage of LBP patients prescribed non-recommended medications (opioids, benzodiazepines and/or gabapentinoids), assessed via routinely collected ED data. Anticipated sample size is 2000 patients (n=1000 intervention, n=1000 control) based on average monthly admissions of LBP presentations in the EDs. Secondary outcomes include inpatient admission rate, time to mobilisation, provision of patient education, imaging requests, representation to the ED within 6 months and healthcare costs. In nested qualitative research, we will study ED clinicians’ perceptions of the implementation and identify how benefits can be sustained over time.

Ethics and dissemination

This study received ethical approval from the Metro North Human Research Ethics Committee (HREC/2022/MNHA/87995). Study findings will be published in peer-reviewed journals and presented at international conferences and educational workshops.

Trial registration number

ACTRN12622001536752.

Gaawaadhi Gadudha: understanding how cultural camps impact health, well-being and resilience among Aboriginal adults in New South Wales, Australia--a collaborative study protocol

Por: Yashadhana · A. · Zwi · A. B. · Brady · B. · De Leeuw · E. · Kingsley · J. · O'Leary · M. · Raven · M. · Serova · N. · Topp · S. M. · Fields · T. · Foster · W. · Jopson · W. · Biles · B.
Introduction

The health and well-being of Aboriginal Australians is inextricably linked to culture and Country. Our study challenges deficit approaches to health inequities by seeking to examine how cultural connection, practice and resilience among Aboriginal peoples through participation in ‘cultural camps’ held on sites of cultural significance promotes health and well-being.

Methods and analysis

The study will be undertaken in close collaboration and under the governance of traditional cultural knowledge holders from Yuwaalaraay, Gamilaraay and Yuin nation groups in New South Wales, Australia. Three cultural camps will be facilitated, where participants (n=105) will engage in activities that foster a connection to culture and cultural landscapes. A survey assessing connection to culture, access to cultural resources, resilience, self-rated health and quality of life will be administered to participants pre-camp and post-camp participation, and to a comparative group of Aboriginal adults who do not attend the camp (n=105). Twenty participants at each camp (n=60) will be invited to participate in a yarning circle to explore cultural health, well-being and resilience. Quantitative analysis will use independent samples’ t-tests or 2 analyses to compare camp and non-camp groups, and linear regression models to determine the impact of camp attendance. Qualitative analysis will apply inductive coding to data, which will be used to identify connections between coded concepts across the whole data set, and explore phenomenological aspects. Results will be used to collaboratively develop a ‘Model of Cultural Health’ that will be refined through a Delphi process with experts, stakeholders and policymakers.

Ethics and dissemination

The study has ethics approval from the Aboriginal Health and Medical Research Council (#1851/21). Findings will be disseminated through a combination of peer-reviewed articles, media communication, policy briefs, presentations and summary documents to stakeholders.

Predictors of outcome in sciatica patients following an epidural steroid injection: the POiSE prospective observational cohort study protocol

Por: Stynes · S. · Snell · K. I. · Riley · R. D. · Konstantinou · K. · Cherrington · A. · Daud · N. · Ostelo · R. · O'Dowd · J. · Foster · N. E.
Introduction

Sciatica can be very painful and, in most cases, is due to pressure on a spinal nerve root from a disc herniation with associated inflammation. For some patients, the pain persists, and one management option is a spinal epidural steroid injection (ESI). The aim of an ESI is to relieve leg pain, improve function and reduce the need for surgery. ESIs work well in some patients but not in others, but we cannot identify these patient subgroups currently. This study aims to identify factors, including patient characteristics, clinical examination and imaging findings, that help in predicting who does well and who does not after an ESI. The overall objective is to develop a prognostic model to support individualised patient and clinical decision-making regarding ESI.

Methods

POiSE is a prospective cohort study of 439 patients with sciatica referred by their clinician for an ESI. Participants will receive weekly text messages until 12 weeks following their ESIand then again at 24 weeks following their ESI to collect data on leg pain severity. Questionnaires will be sent to participants at baseline, 6, 12 and 24 weeks after their ESI to collect data on pain, disability, recovery and additional interventions. The prognosis for the cohort will be described. The primary outcome measure for the prognostic model is leg pain at 6 weeks. Prognostic models will also be developed for secondary outcomes of disability and recovery at 6 weeks and additional interventions at 24 weeks following ESI. Statistical analyses will include multivariable linear and logistic regression with mixed effects model.

Ethics and dissemination

The POiSE study has received ethical approval (South Central Berkshire B Research Ethics Committee 21/SC/0257). Dissemination will be guided by our patient and public engagement group and will include scientific publications, conference presentations and social media.

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