Using the community-based participatory research (CBPR) methodology, sustained peer group treatment has effectively improved medication adherence. Although many studies investigate the effectiveness of peer group therapy, there is a lack of evidence addressing the cost-effectiveness of CBPR models in low- and middle-income countries. This protocol outlines the methods for the economic evaluation of the PArticipatory Research model for medicaTIon adherenCe In People with diAbetes and hyperTEnsion (PARTICIPATE) trial to determine whether the CBPR approach to enhance medication adherence among patients with diabetes and/or hypertension is cost-effective in India.

A within-trial cost-effectiveness analysis (CEA) from a societal perspective will be conducted alongside a multicentre cluster randomised controlled trial to identify, measure and evaluate the key resource and outcome impacts of a CBPR model compared with usual care aimed at improving medication adherence in adult rural Indian patients with diabetes and/or hypertension. The CEA will provide results in terms of the cost per improvement in medication adherence score, and a cost-utility analysis (CUA) will express the findings as the cost per disability-adjusted life year (DALY) or quality-adjusted life year (QALY) gained. Intervention costs and effects will be projected for the population of Indian adults with diabetes and/or hypertension who are on medication, analysed over the cohort’s lifetime. Results from the modelled CUA will detail incremental costs, costs per death averted and costs per DALY averted/QALY gained for the interventions relative to the comparator. Incremental cost-effectiveness ratios will be computed by dividing the cost difference between the intervention and comparator by the difference in benefits. Health economic evaluation methods, including a lifetime horizon, a 3% discount rate for costs and benefits and a societal perspective, will be followed. The effects of sampling uncertainty on estimated incremental costs and effectiveness parameters, as well as the influence of methodological assumptions (such as the discount rate and study perspective), will be examined through both deterministic and probabilistic sensitivity analyses. Relevant differences in costs, outcomes or cost-effectiveness disparities among subgroups of patients with varying baseline characteristics will also be reported. Results will be illustrated using cost-effectiveness acceptability curves across a range of willingness-to-pay thresholds. Modelled CUA will broaden the target population and time frame to offer decision-makers insights into the cost-effectiveness of the CBPR approach for enhancing medication adherence. Furthermore, a return on investment analysis will be performed to express benefits in monetary terms relative to investments made, allowing for a comprehensive expression of both costs and the full spectrum of intervention benefits in monetary units.

The Institutional Ethics Committee of Sri Aurobindo Medical College and PGI, Indore, provided ethics approval. The results of the main trial and economic evaluation will be submitted for publication in a peer-reviewed journal and disseminated through reports to Indian Council of Medical Research and conference presentations.

Clinical Trial Registry of India (CTRI) CTRI/2024/01/061939.

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.

Cluster randomised trial.

320 000 women from up to 80 hospital maternity units.

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.

The primary outcome is all-cause early (

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.

ISRCTN49639731.

Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality globally. Early diagnosis and intervention are crucial for preventing disease progression. The concept of early COPD is considered to represent the initial phase of the disease course. However, different terms are used, and a standardised definition is lacking. This has hindered research and clinical utility. This systematic review aims first to examine current early COPD research and outline the definitions and terms used to help reach consensus and direct future clinical research. Second, it will identify currently proposed markers and tools for predicting the progression of early COPD and the quality of evidence to help direct future research and facilitate the development of novel management strategies.

This study will search for all clinical studies on early COPD, using a standardised search strategy, searching CENTRAL (the Cochrane Library), MEDLINE (Ovid), PubMed, Scopus, Web of Science and Google Scholar. Titles and abstracts will be reviewed and compared against inclusion and exclusion criteria. Stage 1 of this review will assess the terms and definitions used for early COPD. Stage 2 will assess studies presenting additional markers or tools for predicting the progression of early COPD. Study quality will be assessed using a modified Downs and Black checklist for observational studies and the risk of bias (RoB) 2 tool for randomised controlled trials. This protocol has been registered in PROSPERO (CRD42025645320).

This systematic review will use freely available data within the literature and will not directly involve human participants; therefore, ethical approval is not required. The results of this systematic review will be prepared and submitted for presentation as conference presentation(s) and for publication as a peer-reviewed article.

CRD42025645320.