Health Research Ethics Committee Research Articles

Gastrointestinal and respiratory morbidity when introducing eggs as complementary food: a randomised controlled trial in South African infants

We investigated the incidence and duration of morbidity symptoms among infants aged 6 to 9 months from a low socioeconomic community receiving one egg daily for 6 months. This was a secondary outcome of a randomised controlled trial (RCT) of 500 infants conducted in Jouberton, South Africa. The primary outcome was linear growth. Morbidity data were collected weekly using a symptoms diary and qualitative data with focus group discussions at the endpoint. Ethical approval was obtained from the North-West University Health Research Ethics Committee. The intervention group had a ~ 5% higher incidence of gastrointestinal morbidity (17.0%) compared to the control group (11.9%). Gastrointestinal morbidity without fever tended to be 1.4 times higher in the intervention group (OR: 1.43, 95% CI: 1.03, 1.93; P = 0.058) and tended to be 4 times higher with fever (OR: 4.07, 95% CI: 0.86, 19.23; P = 0.077). The duration of total gastrointestinal and respiratory morbidity was 1.5 days longer in the intervention group (β: 1.491; 95% CI 0.064, 2.918; P = 0.041). Complementary feeding with eggs may have contributed towards an increased risk for gastrointestinal morbidity.

Exploring the relationship between self-stigma and resilience among people living with HIV: a cross-sectional study

HIV is a disease that not only affects physical health but also carries a heavy psychological burden, primarily through self-stigma. Self-stigma can lead to low self-esteem, helplessness, and social isolation, weakening resilience or an individual's ability to survive and adapt to life's challenges. However, there is a gap in knowledge regarding the specific mechanisms by which resilience can mitigate the impact of self-stigma on PLHIV. Whether resilience can completely neutralize the effects of self-stigma or only partially is a question that still requires further answers. This study aims to find out the relationship between self-stigma and resilience among people living with HIV. This research used an observational research design using a cross-sectional approach. 150 HIV patients at Six Public Health Centre of Semarang City were involved in using purposive sampling techniques. The data was gathered using the Indonesian version of CD-RISC and the Indonesian version of the Self-Stigma Questionnaire. Spearman rank correlations were used to analyze the data. The health research ethics committee of the faculty of nursing at Universitas Islam Sultan Agung has approved this study as ethically appropriate. The results found a relationship between self-stigma and resilience where a p-value of 0.006 < α (0.05) with a contingency coefficient value of 0.222. The self-stigma and resilience have a weak correlation. Self-stigma can weaken the ability to create resilience in PLHIV, although the impact may vary depending on other factors. Nurses or health workers need to pay attention to PLHIV, who experience self-stigma, to rise and be resilient while being HIV positive.

Prevalence and Pattern of Labial Frenal Attachments in Adult Nigerians - a Pilot Study

Introduction The frenum is a band of mucous membrane which connects the lips and cheeks to the alveolar mucosa, underlying periosteum, or the gingiva with a primary function of stabilizing the lips and tongue. There are variations of frenal attachment and morphologies, some associated with health, others resulting to loss of periodontium. This study therefore aims to assess the various attachments and morphologies within our study population. Materials and Methods This was a descriptive cross-sectional study conducted at the Oral Diagnosis and Periodontology clinics of the Lagos University Teaching Hospital Idi-Araba among participants who reported to both clinics. Convenience sampling method was employed in participants’ selection, and interviewer-administered questionnaires were used for data collection and documentation of socio-demographic variables, and findings of intra-oral examination. Ethical approval was obtained from the institutional Health Research Ethics Committee and informed consent was obtained from each participant. Data was analyzed using the Statistical Product and Service Solutions (SPSS) version 27. P values < 0.05 were statistically significant. Results The study comprised 337 participants, 203 (60.2%) were females. Mean age was 34.6±15.2 years. The frenal attachment distribution in the maxilla was mucosal 204 (60.5%), gingival 105 (31.2%), papillary 23 (6.8%), and papillary penetrating 5 (1.5%);while in the mandible, 233 (69.1%), 92 (27.3%), 9 (2.7%) and 3 (0.9%) presented with mucosal, gingival, papillary, and papillary penetrating frenal attachment respectively. Simple frenum was the most prevalent frenum morphology in the maxilla [328 (97.3%)] and the mandible [321 (95.2%)], followed by trifid frenum in both maxilla [5 (1.5%)] and mandible [4 (1.2%)]. Diastema was present in 27.6% in maxilla and 11.0% in the mandible. Conclusion In this study, mucosal type was predominant among all age groups. Males presented more with gingival and mucosal type of frenal insertion, while females presented more with papillary type of frenal insertion. Papillary and/or papillary penetrating were significantly associated with the presence of diastema.

Comparing qualitative and quantitative echocardiographic markers to assess cardiac contractility in newborn infants: protocol for a prospective cohort study

IntroductionNeonatologist-performed echocardiography (NPE) is increasingly used in the neonatal intensive care unit, aiding clinicians in enhancing diagnostic precision and guiding treatment decisions based on underlying pathophysiology. Experienced NPE operators typically...

A Self-led Self-management Intervention Supporting Teens with IBD (ASSIST-IBD): protocol for a feasibility study of a novel digital treatment adherence intervention

IntroductionTreatment non-adherence is common in young people with inflammatory bowel disease (IBD), yet support is lacking. A self-led self-management intervention supporting teens with IBD (ASSIST-IBD) is a new theory-based digital...

Evaluating the impact of the global evidence, local adaptation (GELA) project for enhancing evidence-informed guideline recommendations for newborn and young child health in three African countries: a mixed-methods protocol

BackgroundPoverty-related diseases (PRD) remain amongst the leading causes of death in children under-5 years in sub-Saharan Africa (SSA). Clinical practice guidelines (CPGs) based on the best available evidence are key to strengthening health systems and helping to enhance equitable health access for children under five. However, the CPG development process is complex and resource-intensive, with substantial scope for improving the process in SSA, which is the goal of the Global Evidence, Local Adaptation (GELA) project. The impact of research on PRD will be maximized through enhancing researchers and decision makers’ capacity to use global research to develop locally relevant CPGs in the field of newborn and child health. The project will be implemented in three SSA countries, Malawi, South Africa and Nigeria, over a 3-year period. This research protocol is for the monitoring and evaluation work package of the project. The aim of this work package is to monitor the various GELA project activities and evaluate the influence these may have on evidence-informed decision-making and guideline adaptation capacities and processes. The specific project activities we will monitor include (1) our ongoing engagement with local stakeholders, (2) their capacity needs and development, (3) their understanding and use of evidence from reviews of qualitative research and, (4) their overall views and experiences of the project.MethodsWe will use a longitudinal, mixed-methods study design, informed by an overarching project Theory of Change. A series of interconnected qualitative and quantitative data collections methods will be used, including knowledge translation tracking sheets and case studies, capacity assessment online surveys, user testing and in-depth interviews, and non-participant observations of project activities. Participants will comprise of project staff, members of the CPG panels and steering committees in Malawi, South Africa and Nigeria, as well as other local stakeholders in these three African countries.DiscussionOngoing monitoring and evaluation will help ensure the relationship between researchers and stakeholders is supported from the project start. This can facilitate achievement of common goals and enable researchers in South Africa, Malawi and Nigeria to make adjustments to project activities to maximize stakeholder engagement and research utilization. Ethical approval has been provided by South African Medical Research Council Human Research Ethics Committee (EC015-7/2022); The College of Medicine Research and Ethics Committee, Malawi (P.07/22/3687); National Health Research Ethics Committee of Nigeria (01/01/2007).

Intravenous ferric carboxymaltose versus oral ferrous sulphate for the treatment of moderate to severe postpartum anaemia in Nigerian women (IVON-PP): protocol for an open-label randomised controlled type 1 hybrid effectiveness-implementation trial

IntroductionPostpartum anaemia is often caused by iron deficiency with onset during the antepartum period and can be exacerbated by excessive blood loss at birth. Its prevalence is estimated as 50–80%...

Disparity between statistical and clinical significance in published randomised controlled trials indexed in PubMed: a protocol for a cross-sectional methodological survey

IntroductionThe commonly used frequentist paradigm of null hypothesis statistics testing with its reliance on the p-value and the corresponding notion of ‘statistical significance’ has been under ongoing criticism. Misinterpretation and...

Does metformin prolong pregnancy in preterm pre-eclampsia? A study protocol for a South African, hospital-based double-blind, randomised, placebo-controlled trial

IntroductionPreterm pre-eclampsia is a leading cause of maternal morbidity and mortality. The Pre-eclampsia Intervention 2 (PI 2) trial suggested that metformin sustained release (XR) may prolong gestation by a week...

Exploring presence practices: a study of unit managers in a selected Provincial Hospital in Free State Province

BackgroundNursing presence depends on an individual’s belief system, truths, sensory experience, professional skills, and active listening. Thus, one may assume that presence occurs when nurses care for patients in a kind and compassionate way. This study aimed to explore and describe presence practices amongst unit managers in a selected provincial hospital in Free State Province.MethodsA qualitative research approach with an exploratory descriptive contextual research design was employed in this study. A purposive nonprobability sampling technique was utilised to select participants. Data were collected through semi-structured interviews and analysed using the six steps of thematic qualitative data analysis. The study’s trustworthiness was ensured through ascertaining credibility, dependability, confirmability, transferability, and authenticity. Approval to conduct the study was obtained from the North-West University Health Research Ethics Committee (NWU-HREC), DoH in the Free State Province, and the CEO (the gatekeeper) of the selected hospital.ResultsFour themes were generated, namely, presence practices amongst unit managers in a selected provincial hospital in Free State, the impact of presence practices on hospital dynamics in a selected provincial hospital in Free State, unit managers’ practices of relational care and human connectedness in the unit, and the perceptions of unit managers on barriers to presence practices in a selected provincial hospital in Free State. Each of these themes presents categories and sub-categories. Unit managers actively foster supportive work cultures, effective management, human connectedness and relational care, and effective communication to yield team cohesion and positive impacts on patient care. Unit managers also display resilience and highlight the need for ongoing support from colleagues and top management.ConclusionUnit managers exhibit diverse presence practices which emphasise their commitment through visibility and accessibility despite staff shortages and resource constraints.

Consumer Profiles and Drink Menus Made from Medicinal Plants at the Jamu Cafe in Depok Sleman District, Yogyakarta

The use of medicinal plants as ingredients in making drinks in cafes is increasing along with the number of cafes. Herbal café makes a unique menu using medicinal plants in drink recipes to produce a distinctive taste, color, and aroma. This research aims to identify visitor profiles and drink menus made from medicinal plants and explore the understanding of visitors and cafe owners regarding the benefits of medicinal plants added to drinks. The research data collection technique uses a questionnaire equipped with an interview sheet. The questionnaires and interview sheets used have been tested for language comprehension and validity. The research was conducted at 272 cafes in Depok District, Sleman Regency, Special Region of Yogyakarta. The sample was determined using purposive sampling, data was collected after obtaining ethical clearance approval from the Health Research Ethics Committee Team. Data was obtained through filling out surveys by visitors and cafe owners, complemented by interviews with cafe owners. Data was collected three times: August, September, and October 2023. Data analysis was carried out descriptively and qualitatively. Most herbal cafe visitors (70%) are aged between 21–30 years with the majority of professions (44%) being students. The source of information about herbal cafe menus was mostly obtained (56%) from friends or family, and the frequency of visits to cafes was mostly (82%) between 1–5 times per month. More than 98% of visitors stated the benefits of medicinal plants in the drink menu, namely as a refresher or body warmer. There are 14 types of medicinal plants used as ingredients in the herbal cafe's drink menu, with a total monthly requirement for all medicinal plants of 545.1 kilograms; ginger ranks among the highest requirements. Recipe information for the menu was obtained from the family, the Ministry of Health Republic Indonesia website, and the herbal cafe owner made the recipe independently.

Comprehensive observational study evaluating the enduring effectiveness of 4CMenB, the meningococcal B vaccine against gonococcal infections in the Northern Territory and South Australia, Australia: study protocol

IntroductionThe effectiveness of antibiotics for treating gonococcal infections is compromised due to escalating antibiotic resistance; and the development of an effective gonococcal vaccine has been challenging. Emerging evidence suggests that...

Cost analysis for initiating an integrated package of essential non-communicable disease interventions (PEN-Plus) in Kondoa District Hospital, Tanzania: a time-driven activity-based costing (TDABC) study protocol

IntroductionNon-communicable diseases (NCDs) constitute approximately 74% of global mortality, with 77% of these deaths occurring in low-income and middle-income countries. Tanzania exemplifies this situation, as the percentage of total disability-adjusted...

Knowledge interface co-design of a diabetes and metabolic syndrome initiative with and for Aboriginal people living on Ngarrindjeri country

ObjectivesThis research program involves two phases to identify enablers and barriers to diabetes care for Aboriginal people on Ngarrindjeri country; and co-design a strength-based metabolic syndrome and Type 2 Diabetes (T2D) remission program with the Ngarrindjeri community. Study designA study protocol on qualitative research. MethodsThe study will recruit Aboriginal people living on Ngarrindjeri country above 18 years of age with a diagnosis of metabolic syndrome or T2D. Recruitment for phases one and two will occur through the Aboriginal Health Team at the Riverland Mallee Coorong Local Health Network. The lived experiences of T2D will be explored with 10–15 Aboriginal participants, through an Aboriginal conversational technique called ‘yarning’ (60–90 min) in phase 1. Elders and senior community representatives (n = 20–30) will participate in four co-design workshops (2–4 h) in phase 2. Qualitative data will be transcribed and thematically analysed (NVivo version 12). The analysis will focus on protective factors for the Cultural Determinants of Health. Ethics approval was obtained from Aboriginal Health Research Ethics Committee in South Australia (04-22-1009), and Flinders University Human Research Ethics Committee (5847). ResultsThis work will be used to pilot the co-designed diabetes remission trial. Outcomes will be published in peer-reviewed journals, presented at conferences, focusing on following best practice guidelines from the Australian Institute of Aboriginal and Torres Strait Islander Studies and National Health and Medical Research Council. Research translation will occur through digital posters, manuals, and infographics. ConclusionsThe findings will be summarised to all Aboriginal organisations involved in this study, along with peak bodies, stakeholders, Aboriginal Services, and interested participants.

A protocol for the study of environmental risk factors and candidate gene–environment interactions in neurodegenerative disorders in Nigeria (SERGEND): A cross-sectional descriptive study

Introduction: The risk of developing neurodegenerative disorders (NDDs) such as Alzheimer’s disease and related dementias (ADRD) and Parkinson’s disease and atypical parkinsonism (PDAP), has been alluded to arise predominantly from the interplay between environmental exposures and genetic variability. The contributions of these factors to NDD in Black sub-Saharan Africans are largely unknown. The broad aim of SERGEND is to investigate the effect of specific environmental exposures and genetic variability on the risk of developing ADRD and PDAP in our population. Methods: The SERGEND, a national, multi-center, cross-sectional, descriptive study, will be conducted in Nigeria, within academic hospitals located in all six geopolitical zones of the country. The study population will comprise 3000 consenting adult Nigerians aged 18 years and above, residing within the recruiting geopolitical zone in the preceding 12 months. Cases will be persons with ADRD or PDAP and age-matched healthy controls. Assessments will include dementia and parkinsonism-specific case ascertainment, disease severity, functional status, and environmental risk factors assessment. Genotyping for APOE and SNCA REP1 polymorphic variability will be conducted. Future analyses will be performed on biobanked samples. Ethics and Dissemination: The study protocol was approved by the National Health Research Ethics Committee in Nigeria, with institutional HREC concordant approval for all participating sites before enrollment of the study participants. Written informed consent was obtained from all study participants or identified proxies. The study results will be published in peer-reviewed journals and as conference abstracts. Trial Registration: International Standard Registered Clinical/soCial sTudy Number (ISRCTN) registry (www.isrctn.com). Trial registration number: ISRCTN10548575. Locator ID: https://doi.org/10.1186/ISRCTN10548575.

Assessing adherence and comprehension of cardiovascular medicines with pharmacist intervention post‐acute myocardial infarction: a pilot study

AbstractBackgroundDue to the addition of multiple new medicines following an acute myocardial infarction (MI), medication non‐adherence occurs frequently. Medication education can improve adherence, comprehension, and health‐related outcomes. There is currently limited literature about individualised pharmacist‐led medication education post‐hospital discharge following an MI.AimTo assess whether individualised, pharmacist‐led education increased patient adherence and comprehension of cardiovascular medicines over a 12‐week period following an MI.MethodAll participants completed the Morisky Medication Assessment Scale (MMAS) of self‐reported adherence at 1 week and 12 weeks post‐hospital discharge. Alongside this, a questionnaire was completed to quantify comprehension of their treatment plan. Participants were randomised to receive individualised pharmacist‐led education directed at their medication regimen at 4–6 weeks post‐discharge. Data were analysed using paired t‐tests and mixed‐design analysis of variance (ANOVA). Ethical approval was granted by the Monash Health Human and Research Ethics Committee (Reference no: RES‐21‐0000234L) and the study conforms to the Australian National Statement on Ethical Conduct in Human Research. Informed consent was obtained from all participants via project information sheets, verbal explanations by recruiting pharmacists with reassurance there would be no difference in standard treatment should patients decline involvement in the project, and written consent forms were completed by all participants.ResultsOf the 29 participants, 15 (51%) received pharmacist‐led education. The intervention group's mean MMAS score increased from 6.7 (moderate adherence) at week 1 to 7.6 (moderate adherence) at week 12 post‐hospital discharge (p = 0.009). At 12 weeks, the intervention group demonstrated a statistically significant and greater mean MMAS score compared to the control group (7.6 moderate adherence and 6.9 moderate adherence respectively, p = 0.003). The intervention group's mean comprehension level increased from 58% at 1 week to 90% at 12 weeks (p < 0.05). The intervention group demonstrated a greater mean comprehension level at 12 weeks compared to the control group (90% and 48.21% respectively, p < 0.001).ConclusionThis pilot study demonstrated that individualised, pharmacist‐led education may improve self‐reported medication adherence and comprehension.

Illness duration and quality of sleep among people living with HIV: a cross-sectional study

HIV is a chronic condition that requires ongoing medical management, and sleep disturbances are common among individuals living with the virus. By examining the relationship between the duration of illness and sleep quality, healthcare professionals can gain insights into the unique challenges faced by HIV patients and develop targeted interventions to address their specific sleep-related needs. This study aims to find out the relationship between the illness duration and the quality of sleep among people living with HIV/AIDS. This research used an observational research design using a cross-sectional approach. 128 HIV patients on Balai Kesehatan Masyarakat Wilayah Semarang were involved in using purposive sampling techniques. The data was gathered with medical records and the Pittsburgh Sleep Quality Index (PSQI). Spearman rank correlations were used to analyze the data. This study has been declared ethically appropriate by the Health Research Ethics Committee faculty of Nursing Universitas Islam Sultan Agung. The results found a relationship between the illness duration and quality of sleep where a p-value of 0.019 < α (0.05) with a contingency coefficient value of 0.208. The length of diagnosis and sleep quality have a strong correlation. Nurses and other healthcare providers need to provide interventions for PLHIV to improve sleep quality.

Protocol for a mixed-methods study to develop and feasibility test a digital system for the capture of patient-reported outcomes (PROs) in patients receiving chimeric antigen receptor T-cell (CAR-T) therapies (the PRO-CAR-T study)

IntroductionChimeric antigen receptor (CAR) T-cell therapies are novel, potentially curative therapies for haematological malignancies. CAR T-cell therapies are associated with severe toxicities, meaning patients require monitoring during acute and postacute...

Examining the impact of COVID-19 on Māori:non-Māori health inequities in Aotearoa, New Zealand: an observational study protocol

IntroductionThe COVID-19 pandemic has had both direct and indirect impacts on the health of populations worldwide. While racial/ethnic health inequities in COVID-19 infection are now well known (and ongoing), knowledge...

Views of Nigerian civil servants about compulsory COVID-19 vaccination: A qualitative study.

COVID-19 caused unforeseen global burden, although vaccine strategy rapidly stalled transmission and protected those at risk. Many governments made vaccination mandatory for public space access. This study aimed to elucidate perception of Nigerian civil servants towards mandatory COVID-19 vaccination and elicited their recommendations. This study was conducted in twelve purposively selected states in the six geopolitical zones and the Federal Capital Territory (FCT), Nigeria. Relevant ministries, departments and agencies were selected within the study sites. It was a qualitative study that interviewed consenting civil servants. Ethical approval was obtained from the National Health Research Ethics Committee. Interviews were conducted in person, following a pre-test. Data was analysed using NVivo software version 12. Most participants were willing to take the vaccine if their safety was assured. However, enforcement to do so was a hindrance. Most participants commended the government for the effort to curb COVID-19 transmission and create awareness but were displeased with planning and handling of misconceptions. They recommended a more committed approach to vaccine production and funding by the government. Participants were willing to take the COVID-19 vaccines because the gains of protection outweighed the risks. They suggested a less involuntary approach through reinforcing awareness creation and avoiding threats.Contribution:There is limited qualitative research on perception of Nigerian civil servants regarding mandatory COVID-19 vaccination. Being the main driving force of Nigeria's public service, their views are invaluable. Findings could contribute to future policies in times of emergency.