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Voluntariness of consent in paediatric HIV clinical trials: a mixed-methods, cross-sectional study of participants in the CHAPAS-4 and ODYSSEY trials in Uganda

Por: Makumbi · S. · Bajunirwe · F. · Ford · D. · Turkova · A. · South · A. · Lugemwa · A. · Musiime · V. · Gibb · D. · Tamwesigire · I. K.
Objectives

To examine the voluntariness of consent in paediatric HIV clinical trials and the associated factors.

Design

Mixed-methods, cross-sectional study combining a quantitative survey conducted concurrently with indepth interviews.

Setting and participants

From January 2021 to April 2021, we interviewed parents of children on first-line or second-line Anti-retroviral therapy (ART) in two ongoing paediatric HIV clinical trials [CHAPAS-4 (ISRCTN22964075) and ODYSSEY (ISRCTN91737921)] at the Joint Clinical Research Centre Mbarara, Uganda.

Outcome measures

The outcome measures were the proportion of parents with voluntary consent, factors affecting voluntariness and the sources of external influence. Parents rated the voluntariness of their consent on a voluntariness ladder. Indepth interviews described participants’ lived experiences and were aimed at adding context.

Results

All 151 parents randomly sampled for the survey participated (84% female, median age 40 years). Most (67%) gave a fully voluntary decision, with a score of 10 on the voluntariness ladder, whereas 8% scored 9, 9% scored 8, 6% scored 7, 8% scored 6 and 2.7% scored 4. Trust in medical researchers (adjusted OR 9.90, 95% CI 1.01 to 97.20, p=0.049) and male sex of the parent (adjusted OR 3.66, 95% CI 1.00 to 13.38, p=0.05) were positively associated with voluntariness of consent. Prior research experience (adjusted OR 0.31, 95% CI 0.12 to 0.78, p=0.014) and consulting (adjusted OR 0.25. 95% CI 0.10 to 0.60, p=0.002) were negatively associated with voluntariness. Consultation and advice came from referring health workers (36%), spouses (29%), other family members (27%), friends (15%) and researchers (7%). The indepth interviews (n=14) identified the health condition of the child, advice from referring health workers and the opportunity to access better care as factors affecting the voluntariness of consent.

Conclusions

This study demonstrated a high voluntariness of consent, which was enhanced among male parents and by parents’ trust in medical researchers. Prior research experience of the child and advice from health workers and spouses were negatively associated with the voluntariness of parents’ consent. Female parents and parents of children with prior research experience may benefit from additional interventions to support voluntary participation.

Detection of CTLA-4 level and humeral immune response after the second dose of COVID-19 vaccine in certain Iraqi provinces participants

by Laith A. I. K. Al-Kaif, Hussain Al-Ameri, Wael Rasheed Obaead Alfatlawi, Ammar Eesa Mahdi, Younis A. K. Al-Khafaji, Mohammad Abd-Kadhum Al-Saadi, Alaa H. Al-Charrakh, Raheem T. Al-Mammori, Mohammed Ahmed Akkaif

Background

Evaluating immune responses following COVID-19 vaccination is paramount to understanding vaccine effectiveness and optimizing public health interventions. This study seeks to elucidate individuals’ immune status after administering a second dose of diverse COVID-19 vaccines. By analyzing immune responses through serological markers, we aim to contribute valuable insights into the uniformity of vaccine performance.

Methods

A total of 80 participants were enrolled in this study, with demographic and COVID-19 infection-related data collected for categorization. Serum samples were acquired within a specified timeframe, and SARS-CoV-2 IgM/IgG rapid tests were conducted. Moreover, CTLA-4 levels were measured through ELISA assays, allowing us to assess the immune responses comprehensively. The participants were divided into eight groups based on various factors, facilitating a multifaceted analysis.

Results

The outcomes of our investigation demonstrated consistent immune responses across the diverse types of COVID-19 vaccines administered in Iraq. Statistical analysis revealed no significant distinctions among the vaccine categories. In contrast, significant differences were observed in CTLA-4 among the control group (non-infected/non-vaccinated, infected/non-vaccinated) and infected/Pfizer, non-infected/Pfizer, and infected/Sinopharm, non-infected/sinopharm (P = 0.001, Conclusions

In conclusion, our study’s results underscore the lack of discriminatory variations between different COVID-19 vaccine types utilized in Iraq. The uniform immune responses observed signify the equitable efficacy and performance of these vaccines. Despite minor quantitative discrepancies, these variations do not hold statistical significance, reaffirming the notion that the various vaccines serve a similar purpose in conferring protection against COVID-19.

Study protocol for a national observational cohort investigating frailty, delirium and multimorbidity in older surgical patients: the third Sprint National Anaesthesia Project (SNAP 3)

Por: Swarbrick · C. · Poulton · T. · Martin · P. · Partridge · J. · Moppett · I. K. · SNAP 3 Project Team · Cortes · Evans · Green · Lourtie · Shah · Taylor · Williams
Introduction

Older surgical patients are more likely to be living with frailty and multimorbidity and experience postoperative complications. The management of these conditions in the perioperative pathway is evolving. In order to support objective decision-making for patients, services and national guidance, accurate, contemporary data are needed to describe the impact and associations between frailty, multimorbidity and healthcare processes with patient and service-level outcomes.

Methods and analysis

The study is comprised of an observational cohort study of approximately 7500 patients; an organisational survey of perioperative services and a clinician survey of the unplanned, medical workload generated from older surgical patients. The cohort will consist of patients who are 60 years and older, undergoing a surgical procedure during a 5-day recruitment period in participating UK hospitals. Participants will be assessed for baseline frailty and multimorbidity; postoperative morbidity including delirium; and quality of life. Data linkage will provide additional details about individuals, their admission and mortality.

The study’s primary outcome is length of stay, other outcome measures include incidence of postoperative morbidity and delirium; readmission, mortality and quality of life. The cohort’s incidence of frailty, multimorbidity and delirium will be estimated using 95% CIs. Their relationships with outcome measures will be examined using unadjusted and adjusted multilevel regression analyses. Choice of covariates in the adjusted models will be prespecified, based on directed acyclic graphs.

A parallel study is planned to take place in Australia in 2022.

Ethics and dissemination

The study has received approval from the Scotland A Research Ethics Committee and Wales Research Ethics Committee 7.

This work hopes to influence the development of services and guidelines. We will publish our findings in peer-reviewed journals and provide summary documents to our participants, sites, healthcare policy-makers and the public.

Trial registration number

ISRCTN67043129.

Perceptions of academic staff and students of senior high school in implementing game-based exercises in physical education classes--a research protocol for a qualitative descriptive study

Por: Manlapaz · D. · Vergara · J. A. · Alpuerto · K. M. B. · De Los Santos · I. K. S. · Enriquez · M. U. · Manicio · Z. Z. · Mendres · J. E. F. · Tolosa · C. G. S. · Vilela · Z. G. D. · Zabat · Z. E. G. A.
Background

The COVID-19 pandemic has taken a toll on both physical activity and fitness as several pursuits and activities have been restricted. Coupled with this, increased food intake and sedentary lifestyles have produced poor physical health outcomes. Online physical education classes have been more difficult to conduct given the limitations of the setup. As such, exergaming has been identified as a possible educational tool that could improve students’ motivation, participation and fitness levels and reduce negative behaviours in class while contributing to the current curriculum.

Objectives

The study explores the perspectives of both the physical education academic staff and senior high school students from the University of Santo Tomas on the implementation of exergaming to determine the feasibility of exergaming as an educational tool in the Philippines’ physical education curriculum.

Methodology

A descriptive qualitative design will be used and participants will be selected through criterion sampling. The authors will conduct a process of question development and pilot FGDs beforehand to ensure smooth proceedings. Once done, they will undergo FGDs conducted through Google Meet. Data will be coded and analysed via thematic analysis using manual coding and NVivo V.12 software to summarise central themes and perceptions.

Ethics and dissemination

This study will abide by the Nuremberg Code, Declaration of Helsinki, Belmont Report, Data Privacy Act of 2012 and National Ethical Guidelines (for health-related research) of 2017. The study has received approval from the University of Santo Tomas (UST)-College of Rehabilitation Sciences (CRS) Ethics Review Committee. All participant data will be labelled according to random two-digit computer generated codes to preserve anonymity and stored in password-protected laptops and Google Drive folders to preserve confidentiality. Results will be made available to individual UST physical education academic staff and senior high school students prior to publication in peer-reviewed journal.

Protocol for the PATHOME study: a cohort study on urban societal development and the ecology of enteric disease transmission among infants, domestic animals and the environment

Por: Baker · K. K. · Simiyu · S. · Busienei · P. · Gutema · F. D. · Okoth · B. · Agira · J. · Amondi · C. S. · Ziraba · A. · Kapanka · A. G. · Osinuga · A. · Ouma · C. · Sewell · D. K. · Gaire · S. · Tumwebaze · I. K. · Mberu · B.
Introduction

Global morbidity from enteric infections and diarrhoea remains high in children in low-income and middle-income countries, despite significant investment over recent decades in health systems and water and sanitation infrastructure. Other types of societal development may be required to reduce disease burden. Ecological research on the influence of household and neighbourhood societal development on pathogen transmission dynamics between humans, animals and the environment could identify more effective strategies for preventing enteric infections.

Methods and analysis

The ‘enteric pathome’—that is, the communities of viral, bacterial and parasitic pathogens transmitted from human and animal faeces through the environment is taxonomically complex in high burden settings. This integrated cohort-exposure assessment study leverages natural socioeconomic spectrums of development to study how pathome complexity is influenced by household and neighbourhood infrastructure and hygiene conditions. We are enrolling under 12-month-old children in low-income and middle-income neighbourhoods of two Kenyan cities (Nairobi and Kisumu) into a ‘short-cohort’ study involving repeat testing of child faeces for enteric pathogens. A mid-study exposure assessment documenting infrastructural, behavioural, spatial, climate, environmental and zoonotic factors characterises pathogen exposure pathways in household and neighbourhood settings. These data will be used to inform and validate statistical and agent-based models (ABM) that identify individual or combined intervention strategies for reducing multipathogen transmission between humans, animals and environment in urban Kenya.

Ethics and dissemination

The protocols for human subjects’ research were approved by Institutional Review Boards at the University of Iowa (ID-202004606) and AMREF Health Africa (ID-ESRC P887/2020), and a national permit was obtained from the Kenya National Commission for Science Technology and Innovation (ID# P/21/8441). The study was registered on Clinicaltrials.gov (Identifier: NCT05322655) and is in pre-results stage. Protocols for research on animals were approved by the University of Iowa Animal Care and Use Committee (ID 0042302).

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