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Exploring the feasibility and acceptance of an optimised physiotherapy approach for lateral elbow tendinopathy: a qualitative investigation within the OPTimisE trial

Por: Bateman · M. · Saunders · B. · Cooper · K. · Littlewood · C. · Hill · J. C.
Objectives

To explore the acceptability of an optimised physiotherapy (OPTimisE) intervention for people with lateral elbow tendinopathy (LET) and feasibility of comparing it to usual care in a randomised controlled trial.

Design

Semistructured interviews, analysed using thematic analysis and mapped onto the COM-B model of behaviour change.

Setting

Conducted as part of the OPTimisE Pilot & Feasibility randomised controlled trial within physiotherapy departments in the United Kingdom National Health Service.

Participants

17 patients with LET (purposively sampled to provide representativeness based on age, sex, ethnicity, deprivation index and treatment allocation) and all 8 physiotherapists involved as treating clinicians or site principal investigators.

Results

Four themes were identified. First, participants reported the OPTimisE intervention as acceptable. Second, differences between the OPTimisE intervention and usual care were identified, including the use of an orthosis, holistic advice/education including modifiable risk factors, forearm stretches, general upper body strengthening and a more prescriptive exercise-dosing regimen. Third, participants provided feedback related to the trial resources, which were viewed positively, but identified language translation as a need. Fourth, feedback related to trial processes identified the need for changes to outcome collection and reduction of administrative burden. From the perspective of adopting the OPTimisE intervention, we found evidence that participants were able to change their behaviour. Considering the findings through the lens of the COM-B model, the intervention is likely to be deliverable in practice and the trial can be delivered at scale with some additional support for physiotherapists.

Conclusions

Overall, the OPTimisE intervention was found to be different to usual care and acceptable to patients and physiotherapists. The study highlighted the need to refine trial processes and resources prior to a full-scale trial, to reduce administrative burden, increase support for physiotherapists, improve return rate of outcome questionnaires and provide language translation.

Trial registration number

ISRCTN database 19 July 2021. https://www.isrctn.com/ISRCTN64444585.

Association between long-term use of calcium channel blockers (CCB) and the risk of breast cancer: a retrospective longitudinal observational study protocol

Por: Ho · C. · Ha · N. T. · Youens · D. · Abhayaratna · W. P. · Bulsara · M. K. · Hughes · J. D. · Mishra · G. · Pearson · S.-A. · Preen · D. B. · Reid · C. M. · Ruiter · R. · Saunders · C. M. · Stricker · B. H. · van Rooij · F. J. A. · Wright · C. · Moorin · R.
Introduction

Calcium channel blockers (CCB), a commonly prescribed antihypertensive (AHT) medicine, may be associated with increased risk of breast cancer. The proposed study aims to examine whether long-term CCB use is associated with the development of breast cancer and to characterise the dose–response nature of any identified association, to inform future hypertension management.

Methods and analysis

The study will use data from 2 of Australia’s largest cohort studies; the Australian Longitudinal Study on Women’s Health, and the 45 and Up Study, combined with the Rotterdam Study. Eligible women will be those with diagnosed hypertension, no history of breast cancer and no prior CCB use at start of follow-up (2004–2009). Cumulative dose-duration exposure to CCB and other AHT medicines will be captured at the earliest date of: the outcome (a diagnosis of invasive breast cancer); a competing risk event (eg, bilateral mastectomy without a diagnosis of breast cancer, death prior to any diagnosis of breast cancer) or end of follow-up (censoring event). Fine and Gray competing risks regression will be used to assess the association between CCB use and development of breast cancer using a generalised propensity score to adjust for baseline covariates. Time-varying covariates related to interaction with health services will also be included in the model. Data will be harmonised across cohorts to achieve identical protocols and a two-step random effects individual patient-level meta-analysis will be used.

Ethics and dissemination

Ethical approval was obtained from the following Human research Ethics Committees: Curtin University (ref No. HRE2022-0335), NSW Population and Health Services Research Ethics Committee (2022/ETH01392/2022.31), ACT Research Ethics and Governance Office approval under National Mutual Acceptance for multijurisdictional data linkage research (2022.STE.00208). Results of the proposed study will be published in high-impact journals and presented at key scientific meetings.

Trial registration number

NCT05972785.

REVISE: Re-Evaluating the Inhibition of Stress Erosions in the ICU: a randomised trial protocol

Por: Deane · A. M. · Alhazzani · W. · Guyatt · G. · Finfer · S. · Marshall · J. C. · Myburgh · J. · Zytaruk · N. · Hardie · M. · Saunders · L. · Knowles · S. · Lauzier · F. · Chapman · M. J. · English · S. · Muscedere · J. · Arabi · Y. · Ostermann · M. · Venkatesh · B. · Young · P. · Thabane · L
Introduction

The Re-Evaluating the Inhibition of Stress Erosions (REVISE) Trial aims to determine the impact of the proton pump inhibitor pantoprazole compared with placebo on clinically important upper gastrointestinal (GI) bleeding in the intensive care unit (ICU), 90-day mortality and other endpoints in critically ill adults. The objective of this report is to describe the rationale, methodology, ethics and management of REVISE.

Methods and analysis

REVISE is an international, randomised, concealed, stratified, blinded parallel-group individual patient trial being conducted in ICUs in Canada, Australia, Saudi Arabia, UK, US, Kuwait, Pakistan and Brazil. Patients≥18 years old expected to remain invasively mechanically ventilated beyond the calendar day after enrolment are being randomised to either 40 mg pantoprazole intravenously or an identical placebo daily while mechanically ventilated in the ICU. The primary efficacy outcome is clinically important upper GI bleeding within 90 days of randomisation. The primary safety outcome is 90-day all-cause mortality. Secondary outcomes include rates of ventilator-associated pneumonia, Clostridioides difficile infection, new renal replacement therapy, ICU and hospital mortality, and patient-important GI bleeding. Tertiary outcomes are total red blood cells transfused, peak serum creatinine level in the ICU, and duration of mechanical ventilation, ICU and hospital stay. The sample size is 4800 patients; one interim analysis was conducted after 2400 patients had complete 90-day follow-up; the Data Monitoring Committee recommended continuing the trial.

Ethics and dissemination

All participating centres receive research ethics approval before initiation by hospital, region or country, including, but not limited to – Australia: Northern Sydney Local Health District Human Research Ethics Committee and Mater Misericordiae Ltd Human Research Ethics Committee; Brazil: Comissão Nacional de Ética em Pesquisa; Canada: Hamilton Integrated Research Ethics Board; Kuwait: Ministry of Health Standing Committee for Coordination of Health and Medical Research; Pakistan: Maroof Institutional Review Board; Saudi Arabia: Ministry of National Guard Health Affairs Institutional Review Board: United Kingdom: Hampshire B Research Ethics Committee; United States: Institutional Review Board of the Nebraska Medical Centre. The results of this trial will inform clinical practice and guidelines worldwide.

Trial registration number

NCT03374800.

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.

Factors associated with risk of falling among younger inpatients in a mental health setting—A systematic review

Abstract

Aim

To synthesise evidence related to risk factors of falls among younger mental health inpatients age ≤65 years old.

Background

Hospitalised patients with mental illness are at increased risk of falling. Specific risk factors for falls for younger inpatients are poorly understood.

Design

Systematic review.

Methods

Medline, CINAHL, APA PsycINFO, Scopus and Web of Science were searched for studies published in English till December 2022. The review followed the 2020 PRISMA checklist. Odds ratios and P values of significant risk fall factors and the frequency of factors related to circumstances of falls were extracted.

Results

Nine studies were included and 95 risk factors, across seven categories were extracted. These categories included socio-demographic, fall-related factors, functional status, health and mental status, psychiatric diagnosis and assessment, medication, and staff related factors. Factors related to medication, health and mental status are most reported. Majority of the patients sustained minor or no injury from the fall and circumstances of fall vary across studies.

Conclusion

Factors strongly associated with risk of falls were dizziness, use of psychotropics and antihypertensive drugs. A meta-analysis of risk factors was not possible due to different dependent variables studied, controlled confounding variables and control groups used.

Relevance to clinical practice

Fall prevention is relevant to all patients in mental health settings. Approaches to fall risk assessment and management need to be better tailored to younger mental health patients in the psychiatric setting.

Patient and public contribution

Patient or public contribution was not possible because of the study design.

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