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).
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 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.
by Lauren S. Tailor, Hilary K. Brown, Jessie Cunningham, Simone N. Vigod, Erzsébet Horváth-Puhó, Sonia M. Grandi
ObjectiveThe goal of this scoping review is to summarize how prior studies have measured antidepressant continuation/discontinuation prior to, during, and after pregnancy.
IntroductionPregnant 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 criteriaThe 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.
MethodsWe 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.
ConclusionThis 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
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.
Scoping review.
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.
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.
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.
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.
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.
This review adheres to the preferred reporting items for systematic reviews and meta-analysis protocols extension for scoping reviews.
No patient or public contribution.
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.
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.
The CORE-OM 34 item rating scale was administered both pre- and post-intervention. Service user attendances in secondary care was monitored.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
NHS Scotland during the COVID-19 pandemic and beyond.
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).
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.
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.
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.
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.
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.
Healthcare consumers require diverse resources to assist their navigation of complex healthcare interactions, however, these resources need to be fit for purpose.
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.
Multi-site, parallel, multi-method, prospective cohort study.
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.
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.
Several recommendations were made to improve the end-user experience including ‘how to’ instructions; and scheduling functionality for routine care.
The IV Passport can be safely and appropriately integrated into healthcare, to support consumers.
Patient-/parent-reported feedback suggests the Intravenous Passport is a useful tool for record-keeping, and positive communication between patients/parents, and clinicians.
Not applicable.
Consumers reported their experiences surrounding the use of the IV Passport for up to 6 months.