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Anatomic versus reverse total shoulder replacement for patients with osteoarthritis and intact rotator cuff: the RAPSODI-UK randomised controlled trial protocol

Por: Rodrick · H. L. · Dias · J. · Watts · A. C. · Walton · M. J. · Brealey · S. · Page · R. · Foster · N. E. · Boland · K. · Cunningham · L. J. · Fairhurst · C. · Geoghegan · J. · Greenwood · W. · Hewitt · C. · Kirwan · C. · Leggett · H. · McDaid · C. · Parkes · M. · Parrott · S. · Powell · R.
Introduction

Shoulder osteoarthritis most commonly affects older adults, causing pain, reduced function and quality of life. Total shoulder replacements (TSRs) are indicated once other non-surgical options no longer provide adequate pain relief. Two main types of TSRs are widely used: anatomic TSR (aTSR) and reverse TSR (rTSR). It is not clear whether one TSR type provides better short- or long-term outcomes for patients, and which, if either, is more cost-effective for the National Health Service (NHS).

Methods and analysis

RAPSODI-UK is a multi-centre, pragmatic, two-parallel arm, superiority randomised controlled trial comparing the clinical- and cost-effectiveness of aTSR versus rTSR for adults aged 60+ with a primary diagnosis of osteoarthritis, an intact rotator cuff and bone stock suitable for TSR. Participants in both arms of the trial will receive usual post-operative rehabilitation. We aim to recruit 430 participants from approximately 28 NHS sites across the UK. The primary outcome is the Shoulder Pain and Disability Index (SPADI) at 2 years post-randomisation. Outcomes will be collected at 3, 6, 12, 18 and 24 months after randomisation. Secondary outcomes include the pain and function subscales of the SPADI, the Oxford Shoulder Score, health-related quality of life (EQ-5D-5L), complications, range of movement and strength, revisions and mortality. The between-group difference in the primary outcome will be derived from a constrained longitudinal data analysis model. We will also undertake a full health economic evaluation and conduct qualitative interviews to explore perceptions of acceptability of the two types of TSR and experiences of recovery with a sample of participants.

Ethics and dissemination

Ethics committee approval for this trial was obtained (London - Queen Square Research Ethics Committee, Rec Reference 22/LO/0617) on 4 October 2022. The results of the main trial will be submitted for publication in a peer-reviewed journal and using other professional and media outlets.

Trial registration number

ISRCTN12216466.

Measuring the continuation of antidepressant exposure prior to, during, and after pregnancy: A scoping review protocol

by Lauren S. Tailor, Hilary K. Brown, Jessie Cunningham, Simone N. Vigod, Erzsébet Horváth-Puhó, Sonia M. Grandi

Objective

The goal of this scoping review is to summarize how prior studies have measured antidepressant continuation/discontinuation prior to, during, and after pregnancy.

Introduction

Pregnant individuals and healthcare providers are faced with difficult decisions about whether to continue antidepressants in pregnancy due to the historical exclusion of pregnant women from clinical trials and the lack of rigorous evidence to support these decisions. Prior studies examining the effects of pre- and perinatal antidepressant use on perinatal outcomes using observational data have been inconsistent, primarily due to the binary (ever/never) categorization of exposure, which may not accurately reflect real-world use.

Inclusion criteria

The population for this review consists of pregnant individuals. The concept is the measurement of continued preconception, prenatal, and postpartum antidepressant use. We will include human studies (no restrictions on language or geographic location) with the following study designs: cohort studies, cross-sectional studies, case-control studies, and descriptive analyses or spontaneous reports that reference antidepressant use over time.

Methods

We will conduct a scoping review using the JBI (formerly Joanna Briggs Institute) manual for scoping reviews and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews Checklist (PRISMA-ScR). The search strategy will be performed using database-specific nomenclature in MEDLINE, EMBASE, PsycINFO, Cochrane, Web of Science, and Canada’s Drug Agency Grey Matters Guide for grey literature, limiting the final search to publications since 2022 to include contemporary data. Two independent reviewers will 1) screen titles/abstracts/full-texts and 2) extract data. Findings will summarize measurements of antidepressant continuation during the perinatal period, categorizing studies based on the descriptions of timing, duration, adherence, and exposure ascertainment.

Conclusion

This scoping review will establish the extent to which prior studies have been able to measure continued use to inform a clear definition of continued antidepressant exposure to be used in future studies. Review registration: Open Science Framework https://osf.io/2ewpq

Crying wolf, alarm safety and management in paediatrics: A scoping review

Abstract

Aim

To provide a contemporaneous evidentiary overview of neonatal and paediatric studies investigating alarm-related patient safety and alarm system management. Furthermore, to describe how clinical alarm burden is captured and reported, to identify clinical devices that contribute to alarm burden, to explore alarm-related and patient safety measures and terminologies and to review alarm management initiatives.

Design

Scoping review.

Data Sources

A systematic search of PubMed, Embase, Cumulative Index to Nursing and Allied Health Literature, Scopus and EBSCOhost was conducted from 2013 to 2023 using predetermined search terms, index terms, medical subject headings and truncation.

Methods

Observational and qualitative studies with neonatal and paediatric populations reporting monitoring and alarm practices; and interventional studies reporting the success of alarm safety interventions were included. The quality of the included studies was assessed using the mixed methods appraisal tool.

Results

The search yielded 37 studies of acceptable quality. The majority explored alarm burden associated with physiological monitoring (n = 35; 95%). Alarm definitions were reported in 46% (n = 17) of studies, and commonly included what constituted actionable and non-actionable alarms. While 32% (n = 12) of studies considered alarms in relation to clinical outcomes surrounding patient safety, clinician response to alarms was only reported in 19% (n = 7) of studies. Alarm and monitoring interventions were assessed in 51% (n = 19) of included studies, with categorization into six domains: changing alarm parameters, clinician education, communication and planning, technology, alarm ordering and standardization or guidelines.

Conclusion

This review has demonstrated the enormity of alarms in clinical settings, heterogeneity of alarm definitions and outlined interventions associated with alarm burden and patient safety.

Implication for the Profession/Patient Care

Strategies to ensure appropriate alarm limits are set and clinicians are empowered through education to recognize and respond appropriately to alarms can maximize patient safety.

Reporting Method

This review adheres to the preferred reporting items for systematic reviews and meta-analysis protocols extension for scoping reviews.

Patient or Public Contribution

No patient or public contribution.

Implementation of Positive Advanced Recovery Connections in Primary and Secondary Mental Health Care—A Registered Advanced Nurse Practitioner‐Led Initiative

ABSTRACT

Aim(s)

This study reports on the implementation of a registered advanced nurse practitioner intervention. Aims include improving access, service user outcomes and integration between primary and secondary care.

Design

This paper reports the quantitative results of a mixed methods implementation study. Qualitative data are reported separately. The PARiHS framework informs the implementation process itself, with considerations for nurses and other healthcare professionals explored.

Methods

The CORE-OM 34 item rating scale was administered both pre- and post-intervention. Service user attendances in secondary care was monitored.

Results

Findings suggest that the intervention was associated with clinically significant improvements in global or generic distress, reported by service users, as evidenced by changes in the CORE-OM scores. Access to care was recorded at an average of 3.6 days. Implementation science supported effective and safe implementation with clear governance structures.

Conclusion

Registered advanced nurse practice in mental health clinics which provide full episodes of care results in improved integration and may be associated with positive patient outcomes. Implementation science is taught on Irish nursing programmes and this is important if innovative services are to be embedded in the healthcare system.

Impact

The development of a model of care for mental health Registered Advanced Nurse Practitioners at the interface of primary and secondary care settings may be merited. Positive Advanced Recovery Connections may be associated with improving mental health outcomes and bolstering integration of primary and secondary care services. The utilisation of implementation science highlights the need for collaboration with all stakeholders to overcome barriers and recognise facilitators to attain the necessary model of integrated care.

Patient and Public Contribution

Peer recovery input was provided by members of the service Recovery College, with participation evident in all stages of the project. The psychosocial assessment template was also co-designed.

Study protocol for an open-label, single-arm, mixed methods feasibility study of the MWIQ AI-powered decision support tool for diabetes management in GP practices

Por: Dickson · J. · Cunningham · S. G. · Sainsbury · C. · Rutter · M. K. · Kanumilli · N. · Pearson · E. · Brodie · D. · Stevens · M. · Wake · D. J. · Conway · N.
Introduction

Diabetes affects ~10% of the world’s population and is rising. Treatment costs in the UK are ~15% of the NHS budget. Diabetes-related complications can be lowered through better evidence-based clinician management and patient self-management. MyWay intelligence quotient (MWIQ) is an electronic platform that will provide clinical decision support around the diagnosis and treatment of patients with diabetes. This study evaluates the safety and clinical performance (clinical appropriateness/applicability, clinical impact and clinical usability) of MWIQ.

Methods and analysis

The system will be implemented in real time in four to seven general practitioner (GP) practices. Clinicians with diabetes expertise will be recruited as validators, who will inspect records to ensure system robustness before use, and up to 14 healthcare professionals will use and evaluate the system.

Quantitative and qualitative analyses will be triangulated to assess the MWIQ system. Assessment of clinical outcomes will be made using pseudonymised routinely collected clinical data, including adherence to quality performance indicators, diabetes diagnosis, diabetes investigations (eg, genetic testing), HbA1c, blood pressure, body mass index, cholesterol and foot risk score for the diabetes population concerned. Clinical and validator participants will also submit a weekly questionnaire, and these, along with interviews, which are scheduled during the testing process, will be analysed to provide data on the utility, safety and usability of the system.

Ethics and dissemination

This study was approved, 08/01/2024, by the North of Scotland Research Ethics Committee (REC), IRAS project ID: 305267, REC, reference 23/NS/0134. The study has gained confidentiality advisory group (CAG) support (reference: 24/CAG/0002), medicines and healthcare products regulatory agency (MHRA) and health research authority (27/08/2024) approvals.

Findings will be reported to (1) The funding body, (2) The participating GP practices, (3) The study PPIE group, (4) The MHRA to support a submission for recognition as a class 2 CE/UKCA marked device, (5) Presented at local, national and international conferences and (6) Disseminated by peer-reviewed publications.

Trial registration number

ISRCTN17422256.

The adaptive physical activity programme in stroke (TAPAS): protocol for a process evaluation in a sequential multiple assignment randomised trial

Por: Rocliffe · P. · Whiston · A. · O Mahony · A. · OReilly · S. M. · OConnor · M. · Cunningham · N. · Glynn · L. · Walsh · J. C. · Walsh · C. · Hennessy · E. · Murphy · E. · Hunter · A. · Butler · M. · Paul · L. · Fitzsimons · C. F. · Richardson · I. · Bradley · J. G. · Salsberg · J. · Hayes
Introduction

Participation in physical activity (PA) is a cornerstone of the secondary prevention of stroke. Given the heterogeneous nature of stroke, PA interventions that are adaptive to individual performance capability and associated co-morbidity levels are recommended. Mobile health (mHealth) has been identified as a potential approach to supporting PA post-stroke. To this end, we used a Sequential Multiple Assignment Randomised Trial design to develop an adaptive, mHealth intervention to improve PA post-stroke – The Adaptive Physical Activity programme in Stroke (TAPAS) (Clinicaltrials.Gov NCT05606770). As the first trial in stroke recovery literature to use this design, there is an opportunity to conduct a process evaluation for this type of adaptive intervention. The aim of this process evaluation is to examine the implementation process, mechanism of change and contextual influences of TAPAS among ambulatory people with stroke in the community.

Methods and analysis

Guided by the Medical Research Council Framework for process evaluations, qualitative and quantitative methods will be used to examine the (1) implementation process and the content of TAPAS (fidelity adaptation, dose and reach); (2) mechanisms of change (participants’ response to the intervention; mediators; unexpected pathways and consequences) and (3) influence of the context of the intervention. Quantitative data will be presented descriptively, for example, adherence to exercise sessions. Qualitative data will be collected among TAPAS participants and the interventionist using semi-structured one-to-one or focus group interviews. Transcribed interviews will be analysed using reflexive thematic analysis. Key themes and sub-themes will be developed.

Ethics and dissemination

Ethical approval has been granted by the Health Service Executive Mid-Western Ethics Committee (REC Ref: 026/2022) (25/03/2024). The findings will be submitted for publication and presented at relevant national and international academic conferences.

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.

Exploring associations between active school environments and childrens physical activity, mental health and educational performance in Greater London primary schools: the Health and Activity of Pupils in the Primary Years (HAPPY) study protocol

Por: Ram · B. · Gullett · N. · Benkhelfa · A. · Cunningham · M. · Taghavi Azar Sharabiani · M. · van Sluijs · E. · Siddiqui · N. · Hillsdon · M. · Summerbell · C. · Pallan · M. · Saxena · S.
Introduction

School environments that encourage children to be physically active can embed lifelong positive health behaviours and contribute towards reducing health inequalities. The Health and Activity of Pupils in the Primary Years (HAPPY) study aims to: (1) explore the extent to which the WHO criteria for creating active school environments are implemented by primary schools and (2) examine associations between active school environments and children’s physical activity, mental health and educational performance.

Methods and analysis

The HAPPY study is a quasi-experimental study comprising: (1) a survey of state-funded Greater London primary schools to identify implementation of the WHO’s six criteria and (2) a cross-sectional study to examine associations between schools’ active environment score (derived from the school survey) and pupils’ physical activity, mental health and educational performance. For our cross-sectional study, we will recruit up to 1000 year-three children (aged 7–8 years). Our primary outcome is accelerometer (GENEActiv) assessed physical activity, our secondary outcomes are parent-reported child mental health (Strengths and Difficulties Questionnaire) and teacher-reported educational performance (age-related expectations). Using multilevel mixed-effects regression models, we will examine associations between the active environment score and physical activity. Physical activity will be included as a measure of acceleration and also different intensities (light, moderate, vigorous). We will repeat this analysis to examine associations between the active environment score and mental health and educational performance. We will adjust for school characteristics and area-level deprivation and include pupil characteristics (eg, sex, ethnic group) as covariates. Clustering at the school level will be included as a random effect.

Ethics and dissemination

Ethical approval has been obtained from Imperial College Research Ethics Committee (ref: 6800895). Findings will be disseminated through a summary report to all participating schools, peer-reviewed publications, presentations at national and international conferences and National Institute for Health and Care Research policy briefings.

Reliability and Validity of Measures Commonly Utilized to Assess Nurse Well-Being

imageBackground A healthy nursing workforce is vital to ensuring that patients are provided quality care. Assessing nurses' well-being and related factors requires routine evaluations from health system leaders that leverage brief psychometrically sound measures. To date, measures used to assess nurses' well-being have primarily been psychometrically tested among other clinicians or nurses working in specific clinical practice settings rather than in large, representative, heterogeneous samples of nurses. Objectives This study aimed to psychometrically test measures frequently used to evaluate factors linked to nurse well-being in a heterogeneous sample of nurses within a large academic health system. Methods This cross-sectional, survey-based study used a convenience sample of nurses working across acute care practice settings. A total of 177 nurses completed measures, which included the Professional Quality of Life, the short form of the Professional Quality of Life measure, the two-item Connor–Davidson Resilience Scale, the five-item World Health Organization Well-Being Index, the Secondary Traumatic Stress Scale, and the single-item Mini-Z. Internal reliability and convergent validity were assessed for each measure. Results All the measures were found to be reliable. Brief measures used to assess domains of well-being demonstrated validity with longer measures, as evident by significant correlation coefficients. Discussion This study provides support for the reliability and validity of measures commonly used to assess well-being in a diverse sample of nurses working across acute care settings. Data from routine assessments of the nursing workforce hold the potential to guide the implementation and evaluation of interventions capable of promoting workplace well-being. Assessments should include psychometrically sound, low-burden measures, such as those evaluated in this study.

An mHealth application for chronic vascular access: A multi‐method evaluation

Abstract

Background

Healthcare consumers require diverse resources to assist their navigation of complex healthcare interactions, however, these resources need to be fit for purpose.

Aim

In this study, we evaluated the utility, usability and feasibility of children, families and adults requiring long-term intravenous therapy using a recently developed mobile health application (App), intravenous (IV) Passport.

Design

Multi-site, parallel, multi-method, prospective cohort study.

Methods

A multi-site, multi-method study was carried out in 2020–2021, with 46 participants (20 adults, 26 children/family) reporting on their experiences surrounding the use of the IV Passport for up to 6 months.

Results

Overall, utility rates were acceptable, with 78.3% (N = 36) using the IV Passport over the follow-up period, with high rates of planned future use for those still active in the project (N = 21; 73%), especially in the child/family cohort (N = 13; 100%). Acceptability rates were high (9/10; IQR 6.5–10), with the IV Passport primarily used for documenting new devices and complications. Thematic analysis revealed three main themes (and multiple subthemes) in the qualitative data: Advocacy for healthcare needs, Complexity of healthcare and App design and functionality.

Conclusion

Several recommendations were made to improve the end-user experience including ‘how to’ instructions; and scheduling functionality for routine care.

Implications for the Profession and/or Patient Care

The IV Passport can be safely and appropriately integrated into healthcare, to support consumers.

Impact

Patient-/parent-reported feedback suggests the Intravenous Passport is a useful tool for record-keeping, and positive communication between patients/parents, and clinicians.

Reporting Method

Not applicable.

Patient Contribution

Consumers reported their experiences surrounding the use of the IV Passport for up to 6 months.

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