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Protocol for the economic evaluation alongside the PARTICIPATE (PArticipatory Research model for medicaTIon adherenCe In People with diAbetes and hyperTEnsion) multicenter cluster randomized trial

Por: John · D. · Reddy · P. · Jha · A. · Gupta · H. · Verma · V. · Kumar · D. · Bansal · A. K. · Mahapatra · S. · Rehman · T. · Parida · S. K. · Jena · M. · Pon Ruban · A. C. · Kalyanaraman · S. · Sunitha · K. · Cherian · J. J. · Anand · T.
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Trial registration number

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

Neonatal complications and referral practices at birth: insights from a population-based study in the Indian state of Bihar

Por: Kumar · G. A. · Bisht · I. · Akbar · M. · Dora · S. S. P. · Majumder · M. · Mahapatra · T. · Dandona · R.
Objectives

To explore neonatal survival by type of neonatal complications at birth and referral pattern for these complications by place of delivery.

Setting

Bihar, India.

Participants

Women aged 15–49 years who had given live birth between July 2020 and June 2021.

Primary and secondary measures

Prevalence of neonatal complications at birth, referral pattern by complication and neonatal deaths by type of complication.

Results

Data were available for 6767 (81.8%) newborns including 717 neonatal deaths. The prevalence of at least one neonatal complication at birth was reported for 32.9% (95% CI 32.4 to 33.4) newborns, with the most common complications including difficulty in breathing (21.9%), high fever (20.7%), low birth weight (12.5%) and jaundice (13.2%). A total of 578 (26.6%; 95% CI 25.8 to 27.4) neonates with complications at birth were referred to another health provider, predominantly to private sector (68.1%, 93% and 78.7% from public facility, private facility and home). The complications with high referrals included meconium aspiration syndrome (64.1%; 95% CI: 61.1 to 67.1), inability to pass urine (54.7%; 95% CI: 42.1 to 67.2), difficulty in suckling (49.7%; 95% CI: 46.9 to 52.5), cold to touch (48.5%; 95% CI: 43.5 to 53.6), inability to cry (47.2%; 95% CI: 44.2 to 50.1), pneumonia (45.6%; 95% CI: 42.0 to 49.1), difficulty in breathing (44.0%; 95% CI: 42.5 to 45.6) and lethargy (43.5%; 95% CI: 38.4 to 48.6). Referrals were linked to higher neonatal deaths, in particular, among neonates born at home and referred for complications (84.7%; p

Conclusions

With one-third of the neonates reported to have complications at birth and those referred more likely to die, critical gaps in addressing neonatal complications at birth and improvement in the referral services are urgently needed to reduce neonatal mortality.

Misinformation on cardiovascular disease spreads through social networks: a scoping review protocol

Por: Bhandari · B. · Zafra-Tanaka · J. H. · Mahapatra · P. · Njelekela · M. · Infante-Garcia · M. M. · Ramalingam · S. · Gonzalez-Rivas · J. P.
Introduction

Misinformation about cardiovascular health has the potential to negatively impact public health outcomes. Understanding the nature and spread of such misinformation is crucial for developing effective interventions to mitigate this potential risk. However, despite the critical importance of this issue, there is a gap in comprehensive reviews mapping the existing literature on cardiovascular health misinformation. This scoping review aims to map the existing literature on cardiovascular health misinformation, identifying its spread, prevalence, impact and strategies for correction across diverse populations and settings.

Methods

This review will follow the Joanna Briggs Institute guidelines for conducting a scoping review. A comprehensive search will be conducted across multiple databases, including MEDLINE, EMBASE, SCOPUS and Web of Science, along with grey literature sources. The last date of search was January 2025. The review will include studies without date that involve individuals affected by cardiovascular disease (CVD) misinformation, examine the spread, prevalence, impact or correction of misinformation related to cardiovascular health, and capture various cultural, geographic or setting-specific factors. The exclusion criteria include studies that do not directly address misinformation related to CVD. All identified records will be imported into Covidence systematic review software. Two reviewers will independently screen titles and abstracts, followed by full-text reviews of potentially relevant studies. Discrepancies will be resolved through discussion or by consulting a third reviewer. Data extraction will be conducted by two reviewers using a pre-piloted tool, and a descriptive presentation of the findings will be done. Both inductive and deductive content analysis methods will be employed for objectives related to the impact and strategies to combat misinformation.

Ethics and dissemination

Given that the study involves synthesising data from existing published literature, ethical approval is not required. The findings will be disseminated through international conference presentations, published in a peer-reviewed journal and shared with public health organisations and policymakers.

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