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Clinical psychology interventions for reducing obesity have developed alongside pharmacological and surgical treatments, but usually as interventions for individual patients. Any healthcare intervention rests on a logic model: assumptions that through specific physical and social mechanisms, it will produce certain intended outcomes, provided that conducive background conditions (‘contexts’) exist. Using evidence from the feasibility trial preceding a full randomised controlled trial (RCT), this paper assesses the empirical validity of the initial logic model of a new group-based weight management intervention: PROGROUP, designed for patients with body mass index (BMI) ≥40 kg/m2 or ≥35 kg/m2 with comorbidities. We aimed to test whether:
PROGROUP’s programme components produce the intended outcomes at all, whatever their size and how. The intervention can practicably be implemented (‘delivered’) as designed. How the programme and delivery components affected each other.
Multimethod proof-of-concept study by means of realist evaluation of the initial PROGROUP logic model. We:
Elicited the logic model underlying the intervention design. Compared these assumptions with data from a pre-RCT feasibility study in two English and one Welsh National Health Service (NHS) sites during 2021–2023. Revised the logic model in light of the data, noting how much variation in delivery the programme components (therapeutic mechanisms) could tolerate.
Specialised ambulatory mental health services in the English NHS.
Adults with severe obesity (BMI ≥40 kg/m2 or ≥35 kg/m2 with comorbidities).
Group-building techniques to enhance group members’ adoption of evidence-based methods of behaviour change affecting their dietary behaviour and physical activity.
Qualitative outcomes. What kinds of:
Mechanisms were established and triggered by the attempt to implement PROGROUP (secondary outcome, see objective 1 above). Patient behaviours resulted and whether patients sustained them after the intervention ended (primary outcome; see objective 1 above); and what kinds of context affected that (objectives 2 and 3).
Quantitative measures not used.
The initial logic model assumed that the following sequence of mechanisms would produce weight loss: referral from GP to specialist weight management services; further referral to PROGROUP; preparatory individual consultation; facilitated group sessions produce a group identity; group identity reinforces weight management capability and motivation; further individual consultations adjust for individual circumstances; behaviour change outside the treatment setting, producing weight loss. Contexts necessary for these mechanisms to work included: sufficient catchment population; group size, continuity and membership retention; suitable location; facilitator training; and practical support outside the treatment setting.
The findings suggested revisions to the logic model, but more in the delivery components and contextual assumptions than the core therapeutic mechanisms. There was scope to simplify the referral mechanisms. Different professions could implement the model. A realist evaluation of a pre-RCT feasibility study can be used to make the intervention’s logic model more securely evidence-based, serving as a proof-of-concept test for the intervention. It indicated the conditions under which such group psychological interventions might be more widely used.
This study aimed to explore culturally and linguistically diverse (CALD) fathers' early parenting support needs in the perinatal period in Australia.
A qualitative descriptive research study. Participant fathers were recruited using purposive and snowball sampling who self-identified as CALD.
Data were collected through semi-structured telephone interviews with 15 Australian fathers aged between 29 and 56 years in July–November 2022. Data were analysed using Braun and Clarke's six stages of thematic analysis to code, categorise and identify themes from the data.
Four major themes and six sub-themes emerged from the data, ‘Under pressure’, ‘Slipping through the cracks’, ‘Gaining knowledge and support by health professionals’, and ‘Path ahead: changed roles and being supported by peers’ that encompassed fathers' early parenting experiences and support needs in the perinatal period.
Culturally and linguistically diverse fathers experience challenges in navigating maternal health care settings and at times interactions with health professionals. However, findings from this study showed that fathers were determined to navigate resources, services and networks that supported their transition to fatherhood in the early postpartum weeks. There is a need for maternity settings to be a ‘father-inclusive’ environment where informational and practical support is readily available to them. Legislation reform is needed that recognises fathers as parents who require adequate ‘paid’ parental leave entitlements that foster family relationships and recognises the role fathers play in the development of their child.
This study provides insights into the support needs of CALD fathers in the perinatal period. Findings from this study have the potential to shape and design culturally appropriate health services and interventions tailored to CALD fathers that meet their nuanced needs through the lens of cultural competence and trauma informed maternity care.
What problem did the study address?: The study explored the support needs of CALD fathers in the perinatal period. What were the main findings?: The findings revealed CALD fathers feel a sense of responsibility and pressure to live up to socio-cultural expectations and support the family unit while engaging in paid employment to earn a living. At times fathers were not encouraged to be parenting partners by health professionals, and there was an expectation that they would be familiar and have knowledge about pregnancy, labour, birth and the transition to fatherhood. Some fathers struggled with their transition to parenthood either due to lack of paid parental support or limited to no family support. However, some fathers found alternatives to manage and adjust in the early weeks postpartum, which included peer support groups and online information. Where and on whom will the research have an impact?: The research has the potential to impact all fathers, as the findings may be transferrable across a number of communities. The research also has the potential to influence cultural competence training for health care professionals and inform policy development that employs a family centred model of maternity care inclusive of culturally diverse families.
The paper has adhered to the EQUATOR COREQ reporting guideline.
This study did not include patient or public involvement in its design, conduct or reporting.
by Paola Ximena Gonzalez-Lerma, Crystal Lloyd, Scarlet J. Park, Ken Dawson-Scully
Chemotherapeutic agents used for most common cancers are frequently associated with neurotoxicity, which often include debilitating side effects such as seizures. Docetaxel, one of the most widely and effectively used chemotherapeutic drugs, is associated with an array of symptoms referred to as Docetaxel-Induced Peripheral Neuropathies (DIPNs), including motor neuropathy, tingling, muscle weakness, and numbness. In this study, we use the electroconvulsive assay to model DIPN-related muscle weakness in C. elegans, via shock induction. We show that acutely or chronically exposing nematodes to docetaxel increases time to recovery from shock-induced seizure-like behaviors. Additionally, we find that sildenafil citrate, a PDE-5 inhibitor, and a novel bicyclic bridge compound, Resveramorph-3 (RVM-3), are both effective at rescuing the animals from prolonged seizure-like movement duration following acute and chronic exposure to docetaxel. The results demonstrate that sildenafil citrate and RVM-3 are potential candidates for mitigating the neurological deficits resulting from DIPNs.Administering supplemental oxygen to prevent hypoxaemia is a fundamental treatment for patients hospitalised with acute injury or illness. However, the amount of oxygen administered frequently exceeds that needed to maintain normoxaemia, causing patients to experience hyperoxaemia and wasting supplemental oxygen. Closed-loop, autonomous oxygen titration systems are designed to optimise oxygen delivery by administering the lowest possible oxygen flow that maintains peripheral oxygen saturation (SpO2) within a predefined range. For adults hospitalised with an acute injury or illness, it remains uncertain whether the use of a closed-loop, autonomous oxygen titration system safely increases the proportion of time spent in normoxaemia (SpO2 90%–96%) compared with usual care.
The Strategy to Avoid Excessive Oxygen using Autonomous Oxygen Titration Intervention trial is a multicentre, unblinded, parallel-group, randomised trial being conducted at four level 1 trauma centres in the USA. The trial compares an autonomous oxygen titration system versus usual care among 300 adults hospitalised for major trauma, burn, acute care surgery or acute respiratory illness. The primary outcome is the proportion of patient-time spent within the targeted normoxaemia range (SpO2 90%–96%) as measured by continuous non-invasive pulse oximetry, during the first 72 hours after randomisation. Secondary outcomes include the amount of supplemental oxygen administered and the proportion of time spent in hypoxaemia (SpO22 >96%). Specifying the protocol and statistical analysis plan before the conclusion of enrolment increases the rigour, reproducibility and interpretability of the trial. Enrolment began on 6 May 2024.
The trial protocol was approved by the single institutional review board at the University of Colorado School of Medicine and the Office of Human Research Oversight at the Department of Defense. We will present the results at scientific conferences and submit them for publication in a peer-reviewed journal.
We conducted a pilot randomised controlled trial (the PHaCT study), including a process evaluation to assess the acceptability of a housing-led Critical Time Intervention (CTI) for prison leavers and the use of a trial design. This paper presents the process evaluation findings.
To explore the acceptability of both the intervention and the trial design to participants and those delivering the intervention, and to assess whether the intervention was delivered with fidelity.
A process evaluation following Medical Research Council guidelines. Data collection included semi-structured interviews with participants and CTI caseworkers and observations of intervention delivery. A thematic analysis of interviews and observations was conducted to understand the intervention’s implementation and contextual factors as well as the trial process acceptability.
Participants for the pilot trial were recruited from three prisons in England and Wales where the intervention was being delivered.
While 28 out of 34 trial participants consented to interviews, only one was completed. Seven caseworkers were interviewed.
A housing-led CTI to support people leaving prison at risk of homelessness, involving phased, time-limited support from caseworkers, starting prerelease and continuing postrelease, to help secure stable housing and build independence, without directly providing housing.
The intervention’s acceptability was primarily reflected through the positive feedback and success stories shared by CTI caseworkers, as well as observational data indicating high acceptance among service users. The trial design’s acceptability was challenged by concerns about randomisation and equipoise, with staff viewing randomisation as unethical due to limited support for vulnerable populations. The fidelity to the CTI intervention housing-led approach was adhered to as best as possible; stable housing was prioritised for service users before addressing other needs. Despite these efforts, both sites encountered significant challenges due to limited housing availability and complex systems for securing social housing, particularly for single men leaving prison.
This wider study faced significant challenges which impacted the process evaluation. Despite these issues, the evaluation provides important insights into the challenges of conducting trials on interventions for people leaving prison. The challenges experienced should inform future study designs with similar populations and in similar settings.
To determine whether a full-scale randomised control trial (RCT) assessing the efficacy and cost-effectiveness of a housing led Critical Time Intervention (CTI) is feasible and acceptable.
Pilot parallel two-arm individual level RCT, including process evaluation and embedded exploratory health economic evaluation.
Four prisons for men across England and Wales, UK.
Men leaving prison at risk of homelessness and intervention delivery staff.
CTI has four components: (1) pre-engagement phase: assessing the needs of the client and implementing a plan pre-discharge; (2) transition to community: forming relationships and goal setting; (3) try out: encouraging problem-solving and managing practical issues and (4) transfer of care: developing long-term goals and transferring responsibilities to community providers.
Progression criteria: recruitment, retention, acceptability of the processes (CTI and trial method) and fidelity of intervention delivery. We also assessed the completeness of primary, secondary and exploratory outcome measures and estimated intervention costs.
The recruitment progression criterion was met, with 92% (34/37) of approached individuals consenting to participate (target: 50%). However, the overall recruitment target of 80 was not achieved, and retention was low, only 18% (6/34) provided follow-up data, well below the 60% threshold. Retention was hindered by systemic challenges, including changes to prison release policies and reduced probation support. While the CTI model was acceptable to staff and service users, the trial design, particularly randomisation, was not. Intervention fidelity met the progression criteria. Baseline data collection for health economics and resource use was feasible, and intervention costs were estimated.
This pilot trial identified significant challenges to conducting a full-scale RCT of CTI in this context, particularly around retention, trial acceptability and systemic instability. While CTI remains a promising model, a traditional RCT design may not be viable in this setting without substantial structural and ethical adaptations.
There is substantial literature on opioid pharmacotherapies from a service user perspective, mostly focused on methadone and buprenorphine. However, as a relatively new formulation, much less is known about user experiences and views of Long-Acting Injectable Buprenorphine (LAIB). To date, no published reviews have qualitatively described LAIB service user experience. The objective of this scoping review is to identify and describe the peer-reviewed qualitative studies examining the service user experience of LAIB.
This scoping review will follow the methodology described by Arksey and O’Malley, further adapted by Levac et al and others. The search strategy will be developed in collaboration with an expert librarian and will include searches of Medline, Embase, PsycINFO, CINAHL, Scopus and Web of Science as well as citation chaining. The search dates will range from 2016, when LAIB was first approved, to the date of the final search. Included studies will investigate the perspectives and experiences of LAIB treatment participants with opioid dependence, within an Opioid Treatment Programme (OTP). For service users, the pharmacological formulation of LAIB significantly reshapes both the clinical practice and the social dynamics within OTPs. To effectively capture the depth and nuance of service users’ experiences, this review will be limited to qualitative, mixed-method, case series or case study designs, with a further restriction to peer-reviewed articles published in English. Identified references, with duplicates removed, will be imported into Covidence for title/abstract screening, full-text review and data extraction by two independent reviewers. All decisions on data inclusion or exclusion will be by consensus agreement, using a third reviewer if necessary. A living experience researcher will lead analysis of manuscript content in NVivo using inductive coding to produce a descriptive thematic analysis. The narrative summary will present key study characteristics, quality appraisal and synthesised findings that describe service user experiences and perspectives of LAIB, guided by the Systematic Reviews and Meta-Analysis for Scoping Reviews checklist.
This scoping review undertakes secondary analysis of data in the public domains only and thus does not require ethics approval given no participants are directly involved. The results of the review will be published in a peer-reviewed journal, presented at relevant academic and community conferences, and discussed and disseminated to/with community organisations, service users and policy-makers.
Prepublication history and additional supplemental material for this paper are available online. To view these files, visit: Open Science Framework https://doi.org/10.17605/OSF.IO/XMHKN.
by Priscilla Kapombe, Choolwe Jacobs, Mark W. Tenforde, Kashala Kamalonga, Diane Morof, Terrence Lo, Mweene Cheelo, Lloyd Mulenga, Sombo Fwoloshi, Cordilia M. Himwaze, Patrick Musonda, Mpundu Makasa, Jonas Z. Hines
Zambia has achieved improvements in life expectancy among persons living with HIV (PLHIV) because of high antiretroviral therapy (ART) coverage, which should improve survival due to reductions in AIDS-defining conditions. However, recent estimates of the most common causes of death are not widely available. We utilized mortality surveillance data to report on common causes of death among persons with HIV who died in community settings in Zambia. The Zambian Ministry of Health conducted sentinel mortality surveillance of community deaths in 45 hospitals in 33 of 116 districts from January 2020 through December 2023. Verbal autopsies (VA) were conducted through interviews with relatives or close associates of deceased persons using the 2016 World Health Organization tool. HIV status was reported. A probable cause of death was assigned by a validated computer algorithm (InterVA5). We describe the top assigned causes of death stratified by HIV status. Verbal autopsies were conducted for 67,079 community deaths, of which 11,475 (17.1%) were persons with HIV. The mean age at death was 45 years among persons with HIV and 48 years for persons without HIV (T-test pThis study aims to develop a robust, targeted measure of patient experiences of person-centred care (PCC), informed by the lived experiences of patients with chronic illness using the psychometric theory of Rasch measurement.
The Rasch measurement model was used to analyse the psychometric functioning of 57 candidate items and select appropriate items for a targeted measure.
Participants were recruited from Prolific.com, having experience of both chronic or long-term illness and first-hand experience of primary or secondary care in the UK healthcare setting and completed a survey containing PCC items and descriptors of healthcare experience.
Data from 501 adult persons (49.5% men and 49.7% women) with different types of long-term conditions recruited from the prolific web panel.
For an initial analysis of all 57 candidate items, there were several indicators of misfit, such as signs of local dependence and multidimensionality. The response options worked as intended according to threshold ordering. After removal of misfitting items and refinement for the best spread of locations, a 14-item solution showed good fit to the Rasch model in this UK sample.
The results support a unidimensional measurement of patients’ experiences of PCC, once the local dependency was accommodated. The present work thus offers a 14-item measure of PCC experience. The present work also contains a robust item bank for the further development of dynamic computerised adaptive testing.
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