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Background Chronic pain affects nursing home residents’ daily life. Pain assessment is central to adequate pain management. The overall aim was to investigate effects of a pain management intervention on nursing homes residents and to describe staffs’ experiences of the intervention. Methods A cluster-randomized trial and a mixed-methods approach. Randomized nursing home assignment to intervention or comparison group. The intervention group after theoretical and practical training sessions, performed systematic pain assessments using predominately observational scales with external and internal facilitators supporting the implementation. No measures were taken in the comparison group; pain management continued as before, but after the study corresponding training was provided. Resident data were collected baseline and at two follow-ups using validated scales and record reviews. Nurse group interviews were carried out twice. Primary outcome measures were wellbeing and proxy-measured pain. Secondary outcome measures were ADL-dependency and pain documentation. Results Using both non-parametric statistics on residential level and generalized estimating equation (GEE) models to take clustering effects into account, the results revealed non-significant interaction effects for the primary outcome measures, while for ADL-dependency using Katz-ADL there was a significant interaction effect. Comparison group ( n  = 66 residents) Katz-ADL values showed increased dependency over time, while the intervention group demonstrated no significant change over time ( n  = 98). In the intervention group, 13/44 residents showed decreased pain scores over the period, 14/44 had no pain score changes ≥ 30% in either direction measured with Doloplus-2. Furthermore, 17/44 residents showed increased pain scores ≥ 30% over time, indicating pain/risk for pain; 8 identified at the first assessment and 9 were new, i.e. developed pain over time. No significant changes in the use of drugs was found in any of the groups. Nursing pain related documentation was sparse. In general, nurses from the outset were positive regarding pain assessments. Persisting positive attitudes seemed strengthened by continued assessment experiences and perceptions of improved pain management. Conclusion The implementation of a systematic work approach to pain issues in nursing homes indicates that an increased awareness, collaboration across and shared understanding among the team members of the pain assessment results can improve pain management and lead to decreased physical deterioration or the maintenance of physical and functional abilities among NH residents. However, pain (proxy-measured) and wellbeing level did not reveal any interaction effects between the groups over time. Trial registration The study was registered in ISRCTN71142240 in September 2012, retrospectively registered.

Semi-parametric methods are often used for the estimation of intervention effects on correlated outcomes in cluster-randomized trials (CRTs). When outcomes are missing at random (MAR), Inverse Probability Weighted (IPW) methods incorporating baseline covariates can be used to deal with informative missingness. Also, augmented generalized estimating equations (AUG) correct for imbalance in baseline covariates but need to be extended for MAR outcomes. However, in the presence of interactions between treatment and baseline covariates, neither method alone produces consistent estimates for the marginal treatment effect if the model for interaction is not correctly specified. We propose an AUG–IPW estimator that weights by the inverse of the probability of being a complete case and allows different outcome models in each intervention arm. This estimator is doubly robust (DR); it gives correct estimates whether the missing data process or the outcome model is correctly specified. We consider the problem of covariate interference which arises when the outcome of an individual may depend on covariates of other individuals. When interfering covariates are not modeled, the DR property prevents bias as long as covariate interference is not present simultaneously for the outcome and the missingness. An R package is developed implementing the proposed method. An extensive simulation study and an application to a CRT of HIV risk reduction-intervention in South Africa illustrate the method.

Introduction Differentiated service delivery (DSD) models for HIV treatment decrease health facility visit frequency and limit healthcare facility‐based exposure to severe acute respiratory syndrome coronavirus 2. However, two important evidence gaps include understanding DSD effectiveness amongst clients commencing DSD within 12 months of antiretroviral treatment (ART) initiation and amongst clients receiving only single annual clinical consultations. To investigate these, we pooled data from two cluster‐randomized trials investigating community‐based DSD in Zimbabwe and Lesotho. Methods Individual‐level participant data of newly stable adults enrolled between 6 and 12 months after ART initiation were pooled. Both trials (conducted between August 2017 and July 2019) had three arms: Standard‐of‐care three‐monthly ART provision at healthcare facilities (SoC, control); ART provided three‐monthly in community ART groups (CAGs) (3MC) and ART provided six‐monthly in either CAGs or at community‐distribution points (6MC). Clinical visits were three‐monthly in SoC and annually in intervention arms. The primary outcome was retention in care and secondary outcomes were viral suppression (VS) and number of unscheduled facility visits 12 months after enrolment. Individual‐level regression analyses were conducted by intention‐to‐treat specifying for clustering and adjusted for country. Results and Discussion A total of 599 participants were included; 212 (35.4%), 128 (21.4%) and 259 (43.2%) in SoC, 3MC and 6MC, respectively. Few participants aged <25 years were included (n = 32). After 12 months, 198 (93.4%), 123 (96.1%) and 248 (95.8%) were retained in SoC, 3MC and 6MC, respectively. Retention in 3MC was superior versus SoC, adjusted risk difference (aRD) = 4.6% (95% CI: 0.7%−8.5%). Retention in 6MC was non‐inferior versus SoC, aRD = 1.7% (95% CI: −2.5%−5.9%) (prespecified non‐inferiority aRD margin −3.25%). VS was similar between arms, 99.3, 98.6 and 98.1% in SoC, 3MC and 6MC, respectively. Adjusted risk ratio's for VS were 0.98 (95% CI: 0.92−1.03) for 3MC versus SoC, and 0.98 (CI: 0.95−1.00) for 6MC versus SoC. Unscheduled clinic visits were not increased in intervention arms: incidence rate ratio = 0.53 (CI: 0.16−1.80) for 3MC versus SoC; and 0.82 (CI: 0.25−2.79) for 6MC versus SoC. Conclusions Community‐based DSD incorporating three‐ and six‐monthly ART refills and single annual clinical visits were at least non‐inferior to standard facility‐based care amongst newly stable ART clients aged ≥25 years. ClinicalTrials.gov: NCT03238846 & NCT03438370

Fixed‐dose combination (FDC) therapy is recommended for hypertension management in Nigeria based on randomized trials at the individual level. This cluster‐randomized trial evaluates effectiveness and safety of a treatment protocol that used two‐drug FDC therapy as the second and third steps for hypertension control compared with a protocol that used free pill combinations. From January 2021 to June 2021, 60 primary healthcare centers in the Federal Capital Territory of Nigeria were randomized to a protocol using FDC therapy as second and third steps compared with a protocol that used the same medications in free pill combination therapy for these steps. Eligible patients were adults (≥18 years) with hypertension. The primary outcome was the odds of a patient being controlled at their last visit between baseline to 6‐month follow‐up in the FDC group compared to the free pill group. 4427 patients (mean [SD] age: 49.0 [12.4] years, 70.5% female) were registered with mean (SD) baseline systolic/diastolic blood pressure 155 (20.6)/96 (13.1) mm Hg. Baseline characteristics of groups were similar. After 6‐months, hypertension control rate improved in the two treatment protocols, but there were no differences between the groups after adjustment (FDC = 53.9% versus free pill combination = 47.9%, cluster‐adjusted p = .29). Adverse events were similarly low (<1%) in both groups. Both protocols improved hypertension control rates at 6‐months in comparison to baseline, though no differences were observed between groups. Further work is needed to determine if upfront FDC therapy is more effective and efficient to improve hypertension control rates.

Background Early prevention is a promising strategy for reducing obesity in childhood, and Early Years settings are ideal venues for interventions. This work evaluated an educational intervention with the primary aim of preventing overweight and obesity in pre-school children. Methods A pragmatic, cluster randomised trial with a parallel, matched-pair design was undertaken. Interventions were targeted at both the cluster (Early Years’ Centres, matched by geographical area) and individual participant level (families: mother and 2-year old child). At the cluster level, a staff training intervention used the educational resource Be Active, Eat Healthy. Policies and provision for healthy eating and physical activity were evaluated at baseline and 12-months. The intervention at participant level was the Healthy Heroes Activity Pack : delivered over 6 months by Centre staff to promote healthy eating and physical activity in a fun, interactive way. Child and parent height and weight were measured at four time-points over 2 years. The trial primary outcome was the change in BMI z-score of the child between ages 2 and 4 years. Secondary outcomes consisted of parent-reported measures administered at baseline and two-year follow-up. Results Five pairs of Early Years’ Centres were recruited. Four pairs were analysed as one Centre withdrew (47 intervention families; 34 control families). At the cluster level, improvement in Centre policies and practices was similar for both groups ( p  = 0.830). At the participant level, the intervention group reduced their mean BMI z-score between age 2 and 4 years ( p  = 0.002; change difference 0.49; 95% CI 0.17 to 0.80) whereas the control group showed increasing BMI z-score throughout. Changes in parent-reported outcomes and parent BMI ( p  = 0.582) were similar in both groups. Conclusions The Healthy Heroes educational resource deterred excess weight gain in pre-school children from poor socioeconomic areas. With training, Early Years’ staff can implement the Healthy Heroes programme. Trial registration ISRCTN22620137 Registered 21st December 2016.

Background and Aims Declining sleep quality is common among hemodialysis patients, adversely affecting their quality of life and treatment adherence. Improving sleep is a nursing priority, and targeted interventions might be beneficial. This study aimed to evaluate the effect of a spiritual care program on treatment adherence and sleep quality in hemodialysis patients. Methods This study was a parallel, two‐group, cluster‐randomized clinical trial with a pretest–posttest design. In 2023, 80 hemodialysis patients from two teaching hospitals in Urmia, Iran, were enrolled via convenience sampling and cluster‐randomized by hospital unit to intervention (n = 39) or control (n = 37 completers) groups. The intervention involved four 1 h spiritual care sessions twice weekly post‐dialysis. Outcomes were measured using the End‐Stage Renal Disease Adherence Questionnaire (ESRD‐AQ) and Pittsburgh Sleep Quality Index (PSQI) at baseline and 1 month post‐intervention. Data were analyzed in SPSS v26.0. Normality was checked with Kolmogorov−Smirnov, between‐group differences with independent t‐tests, and within‐group changes with paired t‐tests. Results The mean age of the 76 participants was 52.09 years (range: 20–84 years); 65 participants (85.5%) were male, and 11 (14.5%) were female. Baseline scores showed no significant between‐group differences (adherence: p = 0.848; sleep quality: p = 0.891). Post‐intervention, the intervention group had significantly higher adherence (mean difference: 219.60 [95% CI: 159.51–279.69]; p < 0.001; Cohen's d = 1.92) and better sleep quality (mean difference: −2.67 [95% CI: −1.46 to −3.88]; p = 0.006; Cohen's d = 0.68) compared to the control group. Within the intervention group, adherence improved (p < 0.001; Cohen's d = 2.15) and sleep quality enhanced (p < 0.001; Cohen's d = 0.79); no changes were observed in the control group (p > 0.05). Conclusion A spiritual care program improves treatment adherence and sleep quality in hemodialysis patients. Hospital administrators should integrate spiritual interventions like meditation and counseling, considering barriers such as staffing. Future studies should include diverse populations and longer follow‐ups. Reporting Tool The CONSORT 2010 checklist was used. Summary What does this paper contribute to the wider global community? The Spiritual Care Program can improve treatment adherence and enhance sleep quality in hemodialysis patients. This study's results emphasize the importance of spiritual care for patients receiving hemodialysis. This report urges health authorities to take spiritual care seriously for hemodialysis patients. As the number of hemodialysis patients increases in Iran and worldwide, these findings could significantly help reduce complications and mortality rates.

Introduction The “Migrants’ Approached Self‐Learning Intervention in HIV/AIDS for Tajiks” (MASLIHAT) recruits and trains Tajik labour migrants who inject drugs as peer educators (PEs) in delivering HIV prevention information and encouragement to adopt risk‐reduction norms and practices within their diaspora social networks while reducing their own HIV risk. Methods The MASLIHAT intervention was tested in Moscow in a cluster‐randomized controlled trial with 12 recruitment sites assigned to either the MASLIHAT intervention or an equal‐time peer‐educator training focused on other health conditions (TANSIHAT). From October 2021 to April 2022, 140 male Tajik migrants who inject drugs were recruited as PEs to attend the 5‐session MASLIHAT training or the TANSIHAT non‐HIV comparison condition. Each participant in both groups recruited two network members (NMs) who inject drugs with the intent to share with them the information and positive strategies for change they had learned (n = 280). All PEs and NMs (n = 420) participated in baseline and follow‐up interviews at 3‐month intervals for 1 year. All received HIV counselling and testing. Modified mixed effects Poisson regressions tested for group differences in injection practices, sexual risk behaviours and heavy alcohol use over time. Results At baseline, across both groups, 75% of participants reported receptive syringe sharing (RSS), 42% reported condomless sex and 20% reported binge drinking at least once a month. In contrast to TANSIHAT where HIV risk behaviours remained the same, significant intervention effects that were sustained over the 12 months were observed for receptive syringe and ancillary equipment sharing among both MASLIHAT PEs and NMs (p < 0.0001). Significant declines in the prevalence of sexual risk behaviours were also associated with the MASLIHAT intervention (p < 0.01), but not the comparison condition. Binge alcohol use was not affected in either condition; the MASLIHAT intervention had a transitory effect on drinking frequency that dissipated after 9 months. Conclusions The MASLIHAT peer‐education intervention proved highly effective in reducing HIV‐related injection risk behaviour, and moderately effective in reducing sexual risk behaviour among both PEs and NMs. Network‐based peer education is an important tool for HIV prevention among people who inject drugs, especially in environments that are not amenable to community‐based harm reduction.

This editorial introduces articles in this Special Issue, which are based on presentations given at the 2017 meeting of the Global Forum of Bioethics in Research meeting. The main themes presented at the meeting were the use of cluster randomized trials, stepped-wedge cluster randomized trials, and controlled human infection models in research conducted in low-resource settings. The editorial sets out which ethical issues may arise in the context of alternative trial designs and describes the articles in this issue that addresses some or more of the ethical issues, such as justification of the research design, risk-benefit evaluations and consent.

Summary Objectives A cluster‐randomized trial of home‐based care using primary‐care resources for people with epilepsy has been set up to optimize epilepsy care in resource‐limited communities in low‐ and middle‐income countries. The primary aim is to determine whether treatment adherence to antiepileptic drugs is better with home‐based care or with routine clinic‐based care. The secondary aims are to compare the effects of the two care pathways on seizure control and quality of life. Methods The home‐based intervention comprises epilepsy medication provision, adherence reinforcement, and epilepsy self‐management and stigma management guidance provided by an auxiliary nurse‐midwife equivalent. The experimental group will be compared to a routine clinic‐based care group using a cluster‐randomized design in which the unit of analysis is a cluster of 10 people with epilepsy residing in an area cared for by a single accredited government grass‐roots health care worker. The primary outcome is treatment adherence as measured by monthly tablet counts supplemented by two self‐completed questionnaires. The secondary outcomes include monthly seizure frequency, time to first seizure (in days) after enrollment, proportion of patients experiencing seizure freedom for the duration of the study, and quality of life measured by the “Personal Impact of Epilepsy Scale,” all assessed by an independent study nurse. Results The screening phase and neurologic evaluations and randomizations have been recently completed and follow‐up is underway. Significance The results of the trial are likely to have substantial bearing on the development of governmental policies and strategies to provide coverage and care for patients with epilepsy in resource‐limited countries.

Background Mental health policies outline the need for codesign of services and quality improvement in partnership with service users and staff (and sometimes carers), and yet, evidence of systematic implementation and the impacts on healthcare outcomes is limited. Objective The aim of this study was to test whether an adapted mental health experience codesign intervention to improve recovery‐orientation of services led to greater psychosocial recovery outcomes for service users. Design A stepped wedge cluster randomized‐controlled trial was conducted. Setting and Participants Four Mental Health Community Support Services providers, 287 people living with severe mental illnesses, 61 carers and 120 staff were recruited across Victoria, Australia. Main Outcome Measures The 24‐item Revised Recovery Assessment Scale (RAS‐R) measured individual psychosocial recovery. Results A total of 841 observations were completed with 287 service users. The intention‐to‐treat analysis found RAS‐R scores to be similar between the intervention (mean = 84.7, SD= 15.6) and control (mean = 86.5, SD= 15.3) phases; the adjusted estimated difference in the mean RAS‐R score was −1.70 (95% confidence interval: −3.81 to 0.40; p = .11). Discussion This first trial of an adapted mental health experience codesign intervention for psychosocial recovery outcomes found no difference between the intervention and control arms. Conclusions More attention to the conditions that are required for eight essential mechanisms of change to support codesign processes and implementation is needed. Patient and Public Involvement The State consumer (Victorian Mental Illness Awareness Council) and carer peak bodies (Tandem representing mental health carers) codeveloped the intervention. The adapted intervention was facilitated by coinvestigators with lived‐experiences who were coauthors for the trial and process evaluation protocols, the engagement model and explanatory model of change for the trial.