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The home of collaborative applied health and social care research in Oxford and the Thames Valley.
A systematic review of the association between early comprehensive geriatric assessment and outcomes in hip fracture care for older people.
AIMS: Performance indicators are increasingly used to improve the quality of healthcare provided to hip fracture patients. Joint care, under orthopaedic surgeons and physicians with an interest in older patients, is one of the more common indicators of high-quality care. In this systematic review, we investigated the association between 'comprehensive geriatric assessment' and patient outcomes following hip fracture injury. METHODS: In total, 12 electronic databases and other sources were searched for evidence, and the methodological quality of studies meeting the inclusion criteria was assessed. The protocol for this suite of related systematic reviews was registered with PROSPERO (ID: CRD42023417515). RESULTS: A total of 24,591 articles were reviewed, and 39 studies met the inclusion criteria for the review, involving a total of 25,363 patients aged over 60 years with a hip fracture. There were five randomized clinical trials, three quasi-experimental studies, two non-randomized parallel group control trials, 22 pre-/post-intervention studies, and seven retrospective cohort studies, conducted between January 1992 and December 2021. The timing and content of a comprehensive geriatric assessment was ill-defined in many studies and care pathways were heterogeneous, which precluded meta-analysis of the data. Early comprehensive geriatric assessment was associated with improved outcomes in 31 of the 36 (86%) patient-reported outcomes, including improved mobility (acute/long-term), functional status, and better quality of life. In total, 155 out of 219 (70.78%) clinical outcomes derived from hospital records showed a positive association with early comprehensive geriatric review, including reduced preoperative time and length of hospital stay, reduced incidence of postoperative complications, fewer hospital readmissions, and lower mortality. CONCLUSION: Early comprehensive geriatric assessments after hip fracture in older people is associated with improved patient-reported outcomes and better clinical outcomes such as reduced incidence of complications, length of hospital stay, preoperative waiting time, and mortality. Standardization of the definitions of 'early' and 'comprehensive' geriatric assessments and consistent reporting of care pathway models would improve future evidence synthesis.
Driving cognitive change: a guide to behavioural experiments in cognitive therapy for anxiety disorders and PTSD.
Behavioural experiments are experiential exercises used in Cognitive Behavioural Therapy to drive cognitive change by testing patients' idiosyncratic, emotionally linked beliefs. In this paper, we provide clinical guidance on how to deliver effective behavioural experiments that maximise cognitive change based on lessons learnt over the last 30 years from our work using Cognitive Therapy to treat Panic Disorder (CT-PD), Social Anxiety Disorder (CT-SAD) and Post-Traumatic Stress Disorder (CT-PTSD). We describe key steps for setting up and carrying out powerful experiments, including common blocks and barriers patients and therapists come across when using them.
Inclusion of under-served groups in trials: an audit at a UK primary care clinical trials unit.
BACKGROUND: Clinical trials need to include patients who are representative of the population who may receive the tested interventions in the future. The importance of inclusivity is recognised by ethical and funding bodies and has public support. Appropriate inclusion is required to provide equitable evidence-based healthcare and to comply with ethical principles for research. However, there is little information about the inclusivity of most under-served groups in UK clinical trials. METHODS: This audit assesses the inclusion of under-served groups in trials run by the Oxford Primary Care Clinical Trials Unit (PC-CTU). We included trials with ethical approval between 2017 and 2023. We checked protocols, patient-facing information and selected data collection tools for information on the under-served groups in the INCLUDE guidance and protected characteristics in the UK Equality Act 2010, to identify explicit exclusions and data collection. RESULTS: We included 19 trials. They were in a variety of clinical conditions, testing different types of interventions, both Clinical Trial of an Investigational Medicinal Product (CTIMP) and non-CTIMP. Most were non-commercially funded. We reviewed 21 protocols, 29 Patient Information Sheets/Leaflets and 40 data collection tools. Common exclusions were based on age (19), sex or gender (11), language (8), capacity to consent (14), pregnancy (11), multiple health conditions (10) and severity of illness (17). Trials most often collected data on age (19), sex or gender (15), ethnicity (16), education (11), address (13), mental health conditions (6), who gave consent (19), addiction (6), multiple health conditions (10), severity of illness (17), smoking status (12) and obesity (13). CONCLUSIONS: Often, exclusions were due to the focusing of the trial for a specific group, such as older people, women, or people being treated for a specific severity of condition. However, many explicit exclusions may not have been essential, may have reduced the inclusivity of the trials and might limit the applicability of the trial's findings to people to whom the tested interventions might be relevant. These include the exclusion of people aged under 18, people without English language fluency and people without capacity to consent. All trials could have collected more informative data on under-served group status.
Cognitive bias modification for social anxiety: protocol for a living systematic review of human studies and meta-analysis.
BACKGROUND: Social anxiety is a heightened fear and discomfort in social situations. Cases of elevated distress and impaired functioning can lead to a clinical diagnosis of social anxiety disorder. Altering cognitive biases associated with social anxiety has been suggested as potentially beneficial; however, little is known about the comparative effectiveness of such interventions. The aim of this living systematic review is to examine the efficacy of cognitive bias modification for reducing social anxiety. METHODS: We will search multiple electronic databases for randomised controlled trials evaluating the efficacy of cognitive bias modification for people diagnosed with social anxiety and people exposed to a social stressor. The primary outcome will be change in social anxiety related symptoms; secondary outcomes will be changes in social functioning and quality of life and adverse events. Study selection, data extraction and risk of bias assessment will be done by at least two reviewers using pre-defined tools. We will synthesise data from people with social anxiety diagnosis and those subjected to a simulated social stressor separately using random effects meta-analyses. Heterogeneity will be evaluated by investigating characteristics of included studies and we will conduct a network meta-analysis in order to compare the efficacy of subtypes of cognitive bias modification for social anxiety disorder. We will appraise the strength of the evidence for each outcome by reviewing the overall association, internal and external validity, and reporting biases. Where data allows, we will triangulate the evidence from both sources with a multidisciplinary group of experts. We will also descriptively report factors reported to mediate cognitive bias modification, The review will begin in living mode and the database search will be rerun every three months to identify potential new evidence. We will co-produce this review with members of a global lived experience advisory board. This protocol was registered on 15.10.2024 (CRD42024601380)..
Using qualitative research and the person-based approach to coproduce an inclusive intervention for postpartum blood pressure self-management.
OBJECTIVE: To coproduce an inclusive intervention for blood pressure (BP) self-management post partum. DESIGN: Using the person-based approach, an intervention was coproduced in three phases. Phase 1 entailed intervention coproduction with a diverse patient and public involvement panel and stakeholders (clinical, academic, government and third sector-based). Phase 2 involved intervention optimisation through think-aloud interviews with former patients and clinicians. Phase 3 was user-testing followed by semistructured interviews with current patients and their clinicians. SETTING: Patients and clinicians from primary and secondary care drawn from Southern and Northern England. PARTICIPANTS: Seven former patients and 11 clinicians participated in think-aloud interviews to provide their views of intervention prototypes (phase 2). Additionally, 23 patients and 9 of their clinicians participated in semistructured interviews after using the intervention for 2 weeks (phase 3). INTERVENTION: An interactive patient app-My BP Care-and accompanying leaflet to support BP self-monitoring. These were linked to a clinician dashboard with alerts and an emailing system to facilitate appropriate titration of patient medication. RESULTS: The intervention was codeveloped following these guiding principles to ensure it was accessible and inclusive: easily comprehensible, motivating, simple and quick to use. Interview findings indicated that patient adherence to the intervention was promoted by the initial patient training conducted by the midwives, the enhanced clinical oversight they felt they received as a result of the intervention, the free BP monitor they received, reassurance they received of the medication safety for them and their baby, the intervention's simplicity and the motivating reminders they received. CONCLUSIONS: Through coproduction with a diverse group of patients and stakeholders, and optimisation through testing among further diverse patients and clinicians, we developed a multicomponent intervention that is accessible and engaging for diverse patients, compatible with prevailing clinical practice and adaptable to different clinical contexts.
Addressing international research challenges in child and adolescent mental health during global crises: Experience and Recommendations of the Co-SPACE International Consortium
During the most recent global crisis due to COVID-19 pandemic, mental health researchers globally were tasked with carrying out high-quality and responsive research to understand the changes and long-term trajectories in young people’s mental health symptoms. Comparative international longitudinal research has been recommended as a particularly promising avenue to understand pandemic impacts and facilitate global solutions. The Co-SPACE International Consortium comprises researchers from 14 sites who aimed to compare findings on the impact of the pandemic on young people and family mental health. This paper describes the process and challenges associated with the Consortium’s efforts to combine country-level data to produce global insights for research and clinical practice for the past three years. Several key challenges were identified, particularly about the conduct of international comparative research. These challenges concerned funding, ethics review, data sharing, variations in cultural and local contexts, lack of cross-culturally comparable or meaningful measures, research design, and dissemination. After considering these challenges, we provide a range of recommendations that provide a blueprint for the gathering of timely and robust evidence, the identification of global trends, the mobilisation of resources, and effective support to children and families in public health crises.
Routine testing for group B streptococcus in pregnancy: protocol for a UK cluster randomised trial (GBS3).
INTRODUCTION: It is unclear whether routine testing of women for group B streptococcus (GBS) colonisation either in late pregnancy or during labour reduces early-onset neonatal sepsis, compared with a risk factor-based strategy. METHODS AND ANALYSIS: Cluster randomised trial. SITES AND PARTICIPANTS: 320 000 women from up to 80 hospital maternity units. STRATEGIES: Sites will be randomised 1:1 to a routine testing strategy or the risk factor-based strategy, using a web-based minimisation algorithm. A second-level randomisation allocates routine testing sites to either antenatal enriched culture medium testing or intrapartum rapid testing. Intrapartum antibiotic prophylaxis will be offered if a test is positive for GBS, or if a maternal risk factor for early-onset GBS infection in her baby is identified before or during labour. Economic and acceptability evaluations will be embedded within the trial design. OUTCOMES: The primary outcome is all-cause early (<7 days of birth) neonatal sepsis, defined as either a positive blood/cerebrospinal fluid culture, early neonatal death from infection or a negative/unknown culture status with ≥3 agreed clinical signs or symptoms, who receive intravenous antibiotics ≥5 days. All women giving birth ≥24 weeks' gestation, regardless of mode of birth, and all her babies will be included in the dataset. Cost-effectiveness will be expressed in terms of incremental cost per case of early neonatal sepsis avoided and incremental cost per quality-adjusted life-year associated with each strategy. ETHICS AND DISSEMINATION: The trial received a favourable opinion from Derby Research Ethics Committee on 16 September 2019 (19/EM/0253). The allocated testing strategy will be adopted as standard clinical practice by the site. Women in the routine testing sites will give verbal consent for the test. The trial will use routinely collected data retrieved from National Health Service databases, supplemented with limited participant-level collection of process outcomes. Individual written consent will not be sought. The trial results, and parallel economic, qualitative, implementation and methodological results, will be published in the journal Health Technology Assessment. TRIAL REGISTRATION NUMBER: ISRCTN49639731.
Collaborative risk assessment and management planning in secure mental health services in England: protocol for a realist review.
INTRODUCTION: Secure mental health pathways are complex. They are typically based around secure hospitals, but also interface with justice agencies and other clinical services, including in the community. Consideration of risk is fundamental to clinical care and to decisions relating to a patient's stepwise journey through the pathway. Patient autonomy and involvement in decision-making are policy priorities for health services. However, improving collaboration in risk-related decisions in secure services is complicated by potential issues with insight and capacity and the necessary involvement of other agencies. In addition, although some collaborative approaches are feasible and effective, their impact, mechanisms and the contexts in which they work are not well understood. Therefore, using realist methodology, this review will outline what works, for whom, why and under what circumstances in terms of collaborative risk assessment and management in secure services. METHODS AND ANALYSIS: The review will consist of four stages: (1) Development of an initial programme theory to explain how and why collaborative risk assessment and management works for different groups of people, (2) search for evidence, (3) data selection and extraction and (4) evidence synthesis and development of a final programme theory. Our initial programme theory will be informed by an informal search of the literature and consultation with experts and patient and public involvement and engagement representatives. Following this, our formal literature search will include both the published and unpublished literature. During full text screening, each document will be assessed according to the principles of rigour and relevance and, if included, data will be extracted and synthesised to refine the programme theory. ETHICS AND DISSEMINATION: This protocol is for a review of published literature and so does not require ethical approval. The main output will be the final programme theory. Remaining gaps will inform planned future work to further refine the theory using mixed methods. Our dissemination strategy will be codeveloped with our public and patient involvement group and will include publishing findings in a peer-reviewed journal and presenting findings at relevant professional conferences, as well as engaging patient, carer and clinician groups directly.
The importance of experience: insights into optimal home-blood pressure monitoring regimens from the TASMINH4 Trial.
OBJECTIVES: This study investigates how prior home blood pressure monitoring (HBPM) experience affects blood pressure variability and evaluates if reduced HBPM regimens could be recommended for experienced patients. METHODS: This posthoc analysis of the TASMINH4 trial included self-monitored blood pressure (BP) data from 225 patients. The standard deviation of systolic BP recordings was calculated for each patient-week to assess how BP variability changes with HBPM duration. A subgroup of 84 patients, who submitted at least 1 reading a day for 7 days at months 1, 3, and 6, was analysed to assess the impact of reduced HBPM regimens on BP estimates. RESULTS: Day 1 readings were significantly higher than day 2-7 in the first 3 months of HBPM: 1.1 (95% CI 1.8, 0.4) day 1 vs. day 2. This effect diminished after 6 months: 1.0 (95% CI -0.8, 2.8) day 1 vs. 2. Long term monitoring significantly reduced intra-week BP variability, with the standard deviation of systolic BP recordings within each patient-week significantly reduced after 6 months. After 6 months of HBPM, the inclusion of day 1 readings or use of an abbreviated monitoring regimen had a reduced impact on estimates of mean systolic and diastolic blood pressure. CONCLUSIONS: Long-term HBPM reduces intra-week BP variability, making day 1 readings insignificantly raised after 6 months of HBPM. This provides rationale for different HBPM recommendations: longer regimes, excluding day one readings, for diagnosis and short-term monitoring; and abbreviated regimes including day 1 for longer term monitoring in those with HBPM experience.
The value of mental science: we publish what matters.
Recent changes to US research funding are having far-reaching consequences that imperil the integrity of science and the provision of care to vulnerable populations. Resisting these changes, the BJPsych Portfolio reaffirms its commitment to publishing mental science and advancing psychiatric knowledge that improves the mental health of one and all.
Mechanisms through which exercise reduces symptom severity and/or functional impairment in posttraumatic stress disorder (PTSD): Protocol for a living systematic review of human and non-human studies.
BACKGROUND: Exercise can play an important role in reducing symptom severity and improving functional impairment in patients with posttraumatic stress disorder (PTSD). However, the precise mechanisms underpinning the effect of exercise in PTSD management are not fully understood. This living systematic review aims to synthesize and triangulate the evidence from non-human and human studies to gain insight into the biopsychosocial mechanisms through which exercise reduces symptom severity and functional impairment. METHODS: Independent searches will be conducted in electronic databases to identify eligible studies. Two reviewers will independently conduct the study selection, data extraction, and risk of bias assessment. We will extract outcome data and variables that can act as effect modifiers or as mediators of the effect of exercise. For the non-human studies, outcome data will include the non-human equivalents of PTSD symptom clusters. For human studies, the primary outcome will be PTSD symptom severity. The secondary outcomes will be avoidance symptom severity, reexperiencing symptom severity, hyperarousal symptom severity, negative cognitions and mood severity, functional impairment, loss of PTSD diagnosis, and dropout rates.To explain the biopsychosocial mechanisms through which exercise affects the outcome of interest, we will extract effects that relate to the impact of exercise on potential mediating variables and the effect of the later outcomes. Comparison of within-study direct and indirect effects obtained from mediation analysis, when reported, will provide insight into the importance of the examined mediator.If appropriate, we will synthesize study results using meta-analyses. We will examine potential effect modifiers of the total exercise effect to understand better the impact of exercise on PTSD symptoms and function impairment (when possible). The evidence about the potential mediators of the association between exercise and PTSD-related outcomes will be considered in a consensus meeting when sufficient evidence is available. PROTOCOL REGISTRATION: PROSPERO-ID: 453615.
A Cluster Randomized Controlled Trial of Social Workers in Schools (SWIS) in England
Purpose: “Social Workers in Schools” (SWIS) is a school-based intervention aiming to reduce the need for children to receive child protection services in England. This article reports the findings of a randomized controlled trial (RCT) designed to evaluate SWIS. Method: The study was a two-arm pragmatic cluster RCT with an embedded process and economic evaluation. The intervention physically located social workers within schools. The primary outcome was the rate of child protection inquiries and secondary outcomes included care entry and educational outcomes. Results: 278,858 students in 268 schools were randomized to the intervention (136 schools) or control arm (132 schools). We found no statistically significant effects on primary or secondary outcomes. SWIS was implemented well and positively perceived. Discussion: SWIS appears ineffective in reducing the need for statutory services. The study demonstrates it is possible to conduct a large-scale school-based social work RCT. The study was registered at https://www.isrctn.com/, ref: ISRCTN90922032.