Endometriosis is a chronic condition affecting up to 11% of people presumed female at birth by the age of 44 years, characterised by the growth of tissue similar to the lining of the uterus on other organs. Endometriosis significantly impacts health-related quality of life (HRQoL) and imposes a substantial burden on both individuals and the healthcare system. International guidelines recommend the interdisciplinary management of endometriosis due to its significant biopsychosocial burden; however, research aimed at exploring psychological approaches for endometriosis is limited. This trial aims to evaluate the effectiveness of CodeEndo, an online co-designed interdisciplinary supportive care program, compared with a waitlist control (WLC), on HRQoL and biopsychosocial outcomes in people with a diagnosis of endometriosis.

A hybrid type 1 effectiveness and implementation randomised controlled trial (RCT) will be conducted. Eligible participants will be randomly allocated to either the CodeEndo program (n=176) or WLC group (n=176) for 8 weeks. The primary outcome will be HRQoL, and secondary outcomes will include psychological symptoms (anxiety, depression, stress), self-efficacy, menstrual, bladder and gastrointestinal symptoms, pain, fatigue, sleep, exercise, diet, symptom bothersomeness and physical and psychological well-being, measured at 8 weeks post-randomisation (T2) and 6-month follow-up (T3). Cost-effectiveness will also be examined. Longitudinal qualitative individual interviews (up to n=40) will be conducted with participants who complete the CodeEndo program to explore benefits, barriers and facilitators of ongoing use. Additionally, the CodeEndo program will undergo evaluation by a group of endometriosis healthcare providers, who will assess potential barriers and facilitators to its real-world implementation. Various process evaluation strategies will also be measured to inform future implementation. Data analyses will incorporate mixed-effects regression models on an intention-to-treat basis, cost-consequences and cost-utility, dietary and qualitative thematic analysis.

This protocol received ethics approval from Deakin University Research Ethics Committee (DUREC Ref: 2024-157). Dissemination is expected to include peer-reviewed journal articles, reports, conference presentations as well as websites or social media platforms of relevant chronic pain organisations. Participants will be sent a summary of trial results.

ACTRN12623000598684p.

This study aims to assess the feasibility of respondent-driven sampling (RDS) to recruit participants with recent abortion experiences in humanitarian contexts, and describe the composition of the study sample generated with this sampling method.

This was a three-phase mixed-methods community-engaged research study employing an exploratory and explanatory sequential approach. We conducted in-depth interviews, focus group discussions, an interviewer-administered questionnaire on abortion experiences and a health facility assessment.

Bidibidi Refugee Settlement, Uganda and Kakuma Refugee Camp, Kenya from November 2021 to December 2022.

Using RDS, we recruited 600 participants in Kakuma and 601 participants in Bidibidi with recent abortion experiences. In Kakuma, participants were primarily from Burundi, the Democratic Republic of the Congo and South Sudan; participants in Bidibidi were primarily from South Sudan. Most participants in both sites had completed at least some primary school and were not employed.

RDS recruitment dynamics: convergence and bottlenecks on key sociodemographic variables, recruitment and population homophily, reciprocity of social ties, success and experiences recruiting.

There were minor violations of RDS assumptions, particularly regarding assumptions of reciprocity of ties and seed composition independent of sample. In addition, there was a strong tendency of participants to recruit those from the same home country and living within the same camp zone. However, sample proportions for age, home country, marital status, zone of residence and student status reached equilibrium (stabilised) by around 500 participants at each site, and we were able to quickly attain the study sample size.

While the true representativeness of our sample remains unknown, RDS is a practical and effective recruitment method in humanitarian contexts for sensitive topics, particularly for research questions in which no data or sampling frames exist. However, attention to representativeness and community engagement is essential to optimising its application and ensuring success.

The COVID-19 pandemic disrupted maternal healthcare access globally, leading many women to give birth outside of healthcare facilities, often assisted by traditional birth attendants (TBAs). This study explored the experiences of Kenyan women who gave birth outside of healthcare facilities during the COVID-19 pandemic based on the Person-Centered Maternity Care (PCMC) framework.

This study used data from descriptive qualitative indepth interviews with Kenyan women who gave birth outside of healthcare facilities between March and November 2020. Participants lived within the catchment areas of six health facilities in Kiambu and Nairobi counties and were recruited by community leaders and community health workers. Interviews were conducted in 2020 via phone and inductively coded and analysed by a team of researchers.

A total of 28 Kenyan women who gave birth outside of healthcare facilities between March and November 2020 completed indepth interviews.

In this sample, approximately one-third of women were assisted by TBAs, while the majority were supported by friends and family members. Women generally described salient aspects of their care pertaining to the PCMC domain of supportive care. During labour, birth and the immediate postpartum, women received emotional support, basic medical assistance and instrumental support such as preparing food and baths. However, women also described concerns about giving birth outside of healthcare facilities, including poor hygiene and lack of privacy in birthing spaces as well as instances of verbal and physical harassment by TBAs. Overall, women worried about potential complications during birth, and many women delayed seeking postpartum and postnatal care.

Women who were unable to access healthcare facilities during the COVID-19 pandemic relied on TBAs and/or friends and family for support during labour and birth. These women faced gaps in PCMC, specifically related to supportive care. Given that birthing outside of healthcare facilities remains common globally, particularly during emergencies such as pandemics, TBAs should be supported to provide more person-centred care to women giving birth outside of healthcare facilities.

In the UK, approximately 5.4 million adults live with asthma, of whom one in five have an uncontrolled form. Uncontrolled asthma reduces quality of life and increases healthcare use. Engaging with peers through online health communities (OHCs) can empower patients to self-manage their long-term condition. While OHCs have been in existence for several years and growing numbers of patients access them, the role of primary care in signposting patients to them has been minimal and ad hoc. We have co-developed with patients and healthcare professionals (HCPs) an intervention for adult patients with asthma, consisting of an appointment with a primary care HCP to introduce online peer support and sign patients up to an established asthma OHC, followed by OHC engagement. Feasibility work found the intervention acceptable to patients and HCPs. This protocol outlines our plan to test the intervention’s effectiveness and cost-effectiveness.

An individual randomised controlled trial will be carried out. Eligible participants will be recruited via an online survey sent to adult patients on the asthma register in 50–70 general practices in several UK locations. Participants will be invited to attend a one-off, face-to-face appointment with a primary care HCP, during which they will be individually randomised to the intervention or usual care. An asthma control test (primary outcome) and other measures of clinical effectiveness will be collected at baseline and every 3 months over a 12-month follow-up period. Descriptive and inferential statistics will be used to compare outcome measures between study arms. Cost-effectiveness assessment of the intervention compared with current standard of asthma management in primary care will be reported. A sample of patients and HCPs will be interviewed at study exit and the data analysed thematically.

The study was approved by a National Health Service Research Ethics Committee (reference: 25/NE/0006). Written consent will be obtained from all participants. Findings will be disseminated through various means, including sharing with general practices, conference presentations and peer-reviewed publications.

NCT06849245.

Hypertension is a major health challenge imposing substantial economic and health burdens worldwide. This study compared treatment outcomes and costs between cost-intensive and non-cost-intensive pharmacotherapies, defined by prescribing intervals and the type of drugs, using electronic health record (EHR) data from multiple healthcare facilities, focusing on the type of antihypertensive drug and prescribing patterns.

A retrospective cohort study. A mixed-effects Cox proportional hazards model was used to investigate the association between cardiovascular events and healthcare resource use.

EHRs from 34 primary care facilities in Japan.

Patients prescribed either angiotensin receptor blockers (ARBs) alone or calcium channel blockers (CCBs) alone were included.

During 6629 person-years of follow-up, 71 events were observed. Model diagnostics confirmed the proportional hazards assumption and substantial inter-clinic heterogeneity. The type of drug (ARBs or CCBs) had no statistically significant impact on the incidence of cardiovascular events (HR 0.999, 95% CI 0.603 to 1.655). Similarly, shorter prescribing intervals (less than 36 days) were not significantly associated with the outcome (HR 1.724, 95% CI 0.906 to 3.279). The mean annual medical cost per patient for the cost-intensive (ARB with short prescribing intervals) and non-cost-intensive (CCB with long prescribing intervals) groups was Japanese yen (JPY) 137 023 and JPY 85 911, respectively. Sensitivity analysis using different time windows yielded similar results, confirming the robustness of the findings.

No apparent reduction in cardiovascular events associated with the use of ARBs or shorter prescribing intervals was observed despite the elevated cost caused by intensive pharmacotherapy and frequent clinic visits.

This study explored the barriers to and facilitators of weight reduction among urban, young adults with obesity in Sri Lanka.

A qualitative descriptive study, using the framework method in thematic analysis to identify key themes for barriers and facilitators.

An urban community setting in Sri Lanka in January–March 2022.

62 young adults (18–35 years) with obesity (body mass index ≥25 kgm^-2) representing different socio-demographic characteristics were recruited into the focus group discussions (n=10).

The majority of participants were women (n=40; 64.5%). More than 70% (n=45) of the participants were classified as having class I obesity. Inconsistent knowledge, emotions and mood, poor self-control, inadequate support from others, lack of time, lack of resources and facilities and unsafe environment for physical activities were the identified barriers. The desire to improve appearance and body image, health-related concerns, limitations to day-to-day activities, previous positive experiences, support from others and weight-related victimisation were identified as facilitators.

A multitude of factors were found to interfere with weight-reduction attempts. Due consideration of these barriers and facilitators is important when planning weight management programmes targeting young adults with obesity.

To provide insight into how people cope with living with atrial fibrillation (AF) and taking oral anticoagulants (OACs), informing how services and healthcare delivery could be improved to offer the appropriate support patients require, thereby optimising their quality of life and well-being.

A qualitative study employing focus group discussions (FGDs).

11 primary care units in a socioeconomically deprived area of the Butantan district in São Paulo, Brazil.

Adults (≥18 years) with AF purposively recruited based on sex, age and socioeconomic status.

Saturation was met with three FGDs comprising seven, five and five participants, respectively. Theme one focused on self-management, where many participants discussed their methods for adhering to dietary restrictions and alternative medications, including plant-based options and specific foods, and how they modified their daily activities to reduce AF complications and symptoms. Theme two was rationality, where participants described three main ways that they cope with taking long-term medication (often warfarin): thinking that it controls their AF symptoms; it is an obligation; it prevents morbidity and premature death. Theme three was attitude and emotions, where participants described their initial reactions of shock and fear after diagnosis and ongoing emotions of sadness and frustration due to required self-management activities and regular blood tests. Theme four was medication regimen, where participants discussed difficulties with polypharmacy, changes to AF medication (particularly from non-vitamin K antagonist OACs (NOACs) to warfarin), side effects from taking warfarin and various methods of medication management.

This study presents three key findings with implications for patient care and support. First, the shock and fear experienced during diagnosis due to a lack of knowledge about AF suggests that improvements in public knowledge about AF are needed. Second, people with additional chronic conditions may need improved care and support, given the concern participants had regarding when and how to take their medications safely. Third, improved access to NOACs may reduce the difficulties, frustrations and concerns participants had regarding warfarin use (eg, diet, dose adjustments, self-management and monthly international normalised ratio tests).

To identify currently available functional vision tests and evaluate their use as clinical trial outcome measures in ophthalmology.

Scoping review using the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-analysis Extension for Scoping Reviews) guidelines.

A literature search was conducted in MEDLINE and Embase (via Ovid) for articles published between 1 January 2003 and 1 August 2024. Additional grey literature was sourced from institutional repositories, conference proceedings and a manual citation search. Article screening was conducted against a predefined inclusion criteria by two independent, masked reviewers, with a third reviewer acting as arbiter. The inclusion criteria were English language articles which feature a test assessing functional vision in patients with an ophthalmological disease. Details of source characteristics, test methodology and accessibility and evidence of test validation were collected.

Of 2665 articles returned by the search, 73 were included and 45 unique tests of functional vision were identified. Diseases affecting the peripheral retina were mainly affected, accounting for 77% (56 out of 73) of the diseases featured in all included studies. Overall, 82% (37 out of 45) functional vision tests reported evidence of statistical validation with varying robustness. Functional vision tests were mapped to domains of orientation and mobility, facial recognition, observer-rated task performance, visual search and driving. Obstacle courses assess vision-guided orientation and mobility, correlate highly with clinical measures of visual function in severe peripheral retinal disease and have been validated for use in clinical trials. Their requirement of physical space and time limits utility in multicentre trials; equivalent tests leveraging virtual reality and eye tracking technologies are in development. Early iterations of visual search tests to simulated realistic scenes have demonstrated discriminative ability, even in paediatric patients.

Functional vision tests can facilitate research into future novel ophthalmological treatments that prioritise patients in terms of how clinical benefit is defined. The principal barriers to the uptake of these tests are lack of accessibility, low quality validation and that many tests remain early in their development stage. This review captures the current landscape of functional vision tests and serves as a reference for investigators and regulatory bodies to evaluate the suitability of these tests for ophthalmic clinical trials.

Cardiac surgery is frequently associated with vasoplegia and vasopressor treatment. Both may be associated with postoperative complications and prolonged length of stay. The most frequently used vasopressor is norepinephrine. However, in a pilot, double-blind, randomised controlled trial (RCT) in cardiac surgery patients, angiotensin II was effective in maintaining blood pressure and was associated with a shorter duration of hospital stay than norepinephrine. Furthermore, hyperreninaemic patients were more sensitive to angiotensin II. These findings support the need for a larger RCT to determine whether angiotensin II is superior to norepinephrine as a first-line treatment for low blood pressure after cardiac surgery.

We will conduct a double-blind RCT comparing an infusion of either angiotensin II or norepinephrine intraoperatively and for up to 48 hours after the start of surgery. We will randomly allocate 400 cardiac surgery patients at multiple centres in two countries to either an equipotent angiotensin II or norepinephrine infusion, titrated to a mean arterial pressure of 70–80 mm Hg. The primary outcome will be length of hospital stay. Secondary outcomes will include a composite of renal, cardiovascular and neurological events. A subgroup analysis of patients with elevated baseline renin levels will be undertaken.

Ethical approval has been granted by the Alfred Human Research Ethics Committee on 14 July 2023 (HREC/97814/Alfred-2023). Results will be published on completion of the trial.

Australian and New Zealand Clinical Trials Registry: ACTRN12623000848606.

Research indicates the effectiveness of participatory interventions to address rapid rises in type 2 diabetes in low-income countries. Understanding their transferability to different contexts is a priority. We aimed to analyse how the COVID-19 post-lockdown context and adjustments to a participatory learning and action intervention affected theorised mechanisms of effect in rural Bangladesh and to examine the broader implications of this context and intervention adjustments for developing optimal contexts for participatory interventions.

Mixed methods using longitudinal qualitative and quantitative observation data, focus group discussions and interviews with group and community members and project personnel. We used descriptive content analysis, guided by realist evaluation research questions about context, implementation and mechanisms. We used team reflection to enhance the rigour of our analysis.

Cluster-randomised trial in Alfadanga upazila, Faridpur district, in the central region of Bangladesh. The intervention was implemented between January 2020 and December 2022, during the COVID-19 pandemic.

Participatory group members, community members and project personnel (n=32). Structured observations of participatory groups (n=1820) and unstructured observations of groups and their environments (n=15).

Participatory learning and action community groups of men and women implemented by community-based facilitators.

Due to COVID-19, the participatory learning and action (PLA) intervention was not implemented as planned, which had major effects on the time available to develop the intervention with communities. Communities learnt about diabetes and were motivated to address its causes at an individual level, but community action was a more challenging mechanism to trigger. The post-pandemic context made it difficult to build community rapport, and strategies to engage communities through home visits were challenging. Communities’ prior negative experience in working together and in working with non-governmental organisations led to low community cohesion and low motivation to address diabetes collectively. This also resulted in expectations that the implementing organisation would implement community actions and incentivise attendance at meetings. This misalignment of expectations further disabled relationship building, and community strategies addressing the social causes of diabetes were largely not enacted.

PLA has optimal effects when time is available to build trust and social cohesion. These are contextual elements and mechanisms that need to be activated to enable critical reflection and community action to develop an enabling environment to address type 2 diabetes.

ISRCTN42219712.