Medicine Research Ethics Committee Research Articles

Modular multimodal hospital-home chain physical activity rehabilitation programme (3M2H-PARP) in liver cancer: a protocol for a randomised controlled trial

IntroductionPatients with liver cancer are susceptible to experiencing a decline in muscle mass and function, which can lead to physical frailty and have a negative impact on prognosis. However, there...

Dynamic Level of Fibronectin in Calcium Hydroxide and Mineral Trioxide Aggregate Used as Pulp-Capping Materials

Abstract Objectives The aim of this study was to evaluate the dynamics of fibronectin levels in teeth treated with pulp capping using calcium hydroxide (Ca(OH)2) and mineral trioxide aggregate (MTA). Materials and Methods Test mice were divided into two treatment groups for pulp capping, with group 1 receiving Ca(OH)2 and group 2 receiving MTA. The maxillary first molars of each group's six rats were pulp capped. After pulp capping, blood samples were collected at 1 hour, 24 hours, and 48 hours. A subsequent analysis of the ELISA—enzyme-linked immunosorbent assay—data was performed on additional samples. Hasanuddin University's Faculty of Medicine's Research Ethics Committee allowed the use of experimental animals. Statistical analysis The data normality test uses the Kolmogorov-Smirnov test (sample > 50) or the Shapiro-Wilk test (sample 50) to identify the analytical application of the distribution of the standard data. Wilk test outcomes had a value of p > 0.05; for both the fibronectin and Shapiro leptin levels, the data are considered to be normally distributed. Results Following the application of Ca(OH)2 and MTA to the treated tooth pulp capping, changes in the levels of leptin and fibronectin were observed after 1 hour, 24 hours, and 48 hours. These changes generally tended to decrease leptin levels and increase fibronectin levels. Conclusion As a pulp-capping material, the results showed that MTA materials have higher levels of dynamics of fibronectin than Ca(OH)2. This indicates MTA is a better material for pulp-capping treatment.

Investigating the prevalence of cognitive impairment and dementia in the Northern Ireland Cohort for the Longitudinal Study of Ageing (NICOLA): the Harmonised Cognitive Assessment Protocol (HCAP) cross-sectional substudy

IntroductionThe Northern Ireland Cohort for the Longitudinal Study of Ageing (NICOLA) study is the largest study of ageing in Northern Ireland (NI). The Harmonised Cognitive Assessment Protocol (HCAP) is a...

From tradition to innovation: a comparison of the traditional 4-step approach versus a blended learning modification for technical skills teaching

BackgroundThis experimental study was performed to evaluate the role of blended learning for technical skill teaching on the European Trauma Course (ETC). While online modules are extensively used for theoretical teaching, their role in skills training remains less well explored. The ETC currently relies on the established 4-step technique for teaching technical skills. However, the required large cohort of skilled instructors and the time intensity prove increasingly challenging in a current climate of staff shortages and funding constraints. This study assesses if blended learning, combining pre-course online elements with face-to-face training matches the effectiveness of the traditional 4-step approach whilst being more time-efficient.MethodsIn a randomised, multi-centre trial, the conventional face-to-face 4-step technique for teaching a skill of medium complexity, the application of a pelvic binder, was compared with an innovative blended approach. It was hypothesised that the blended approach was non-inferior for skill performance measured after the teaching session and after two days (skill retention) with the time needed for teaching and student/teacher satisfaction as secondary outcomes.ResultsNinety participants, divided into 44 traditional and 46 blended method students, were analysed. Independent-samples t-test showed no significant difference in performance scores and non-inferiority of the blended approach with a half of one standard deviation margin. A statistically significant difference in mean retention scores favored the blended approach. A Mann–Whitney U Test revealed no significant difference in candidate satisfaction levels but a statistically significant difference in instructors' satisfaction levels in favour of the blended approach. Analysis with Welch' t-test demonstrated that the face-to-face teaching time needed for the blended approach was significantly shorter (by 6 min).ConclusionsThe integration of a blended approach with the 4-step technique for teaching pelvic binder application in the ETC streamlined teaching without compromising skill acquisition quality. This innovative approach addresses traditional limitations and shows promise in adapting medical education to modern learning and teaching demands. We suggest that blended learning could also be applied for other skills taught on life support courses.Trial registration: University of Dundee (Schools of Medicine and Life sciences Research Ethics Committee, REC number 22/59, 28th June 2022).

The impact of community-based integrated HIV and sexual and reproductive health services for youth on population-level HIV viral load and sexually transmitted infections in Zimbabwe: protocol for the CHIEDZA cluster-randomised trial.

Youth have poorer HIV-related outcomes when compared to other age-groups. We describe the protocol for a cluster randomised trial (CRT) to evaluate the effectiveness of community-based, integrated HIV and sexual and reproductive health services for youth on HIV outcomes. The CHIEDZA trial is being conducted in three provinces in Zimbabwe, each with eight geographically demarcated areas (clusters) (total 24 clusters) randomised 1:1 to standard of care (existing health services) or to the intervention. The intervention comprises community-based delivery of HIV services including testing, antiretroviral therapy, treatment monitoring and adherence support as well as family planning, syndromic management of sexually transmitted infections (STIs), menstrual health management, condoms and HIV prevention and general health counselling. Youth aged 16-24 years living within intervention clusters are eligible to access CHIEDZA services. A CRT of STI screening (chlamydia, gonorrhoea and trichomoniasis) is nested in two provinces (16 of 24 clusters). The intervention is delivered over a 30-month period by a multidisciplinary team trained and configured to provide high-quality, youth friendly services.Outcomes will be ascertained through a population-based survey of 18-24-year-olds. The primary outcome is HIV viral load <1000 copies/ml in those living with HIV and proportion who test positive for STIs (for the nested trial). A detailed process and cost evaluation of the trial will be conducted. The trial protocol was approved by the Medical Research Council of Zimbabwe, the Biomedical Research and Training Institute Institutional Review Board and the London School of Hygiene & Tropical Medicine Research Ethics Committee. Results will be submitted to open-access peer-reviewed journals, presented at academic meetings and shared with participating communities and with national and international policy-making bodies. https://clinicaltrials.gov/: NCT03719521.

Evaluating the implementation of a dynamic digital application to enable community-based decentralisation of rheumatic heart disease case management in Uganda: protocol for a hybrid type III effectiveness-implementation study

IntroductionRheumatic heart disease (RHD) affects over 39 million people worldwide, the majority in low-income and middle-income countries. Secondary antibiotic prophylaxis (SAP), given every 3–4 weeks can improve outcomes, provided more...

Paediatric oncology nursing education and training programmes: a scoping review protocol

IntroductionThe care of children with cancer is a highly specialised field which requires well-educated, trained and dedicated nurses to provide high-quality care. In low/middle-income countries, the survival rate of children...

Association between HIV and treatment-resistant hypertension in Malawian adults: a protocol for a case–control study

IntroductionTreatment-resistant hypertension (RH), defined as uncontrolled blood pressure (≥140/90 mm Hg) despite treatment with ≥3 medications of different classes (including diuretics) at optimal doses, is associated with poor prognosis and...

Further development and feasibility randomised controlled trial of a digital programme for adolescent depression, MoodHwb: study protocol

IntroductionA digital programme, MoodHwb, was codesigned with young people experiencing or at high risk of depression, parents/carers and professionals, to provide support for young people with their mood and well-being....

Investigating point-of-care diagnostics for sexually transmitted infections and antimicrobial resistance in antenatal care in Zimbabwe (IPSAZ): protocol for a mixed-methods study

IntroductionSexually transmitted infections (STIs) can cause serious morbidity, including pelvic inflammatory disease, and adverse pregnancy outcomes. In low/middle-income countries, limited laboratory infrastructure has resulted in a syndrome-based approach being used...

Development of a core outcome set and identification of patient-reportable outcomes for primary brain tumour trials: protocol for the COBra study.

IntroductionPrimary brain tumours, specifically gliomas, are a rare disease group. The disease and treatment negatively impacts on patients and those close to them. The high rates of physical and cognitive morbidity differ from other cancers causing reduced health-related quality of life. Glioma trials using outcomes that allow holistic analysis of treatment benefits and risks enable informed care decisions. Currently, outcome assessment in glioma trials is inconsistent, hindering evidence synthesis. A core outcome set (COS) - an agreed minimum set of outcomes to be measured and reported - may address this. International initiatives focus on defining core outcomes assessments across brain tumour types. This protocol describes the development of a COS involving UK stakeholders for use in glioma trials, applicable across glioma types, with provision to identify subsets as required. Due to stakeholder interest in data reported from the patient perspective, outcomes from the COS that can be patient-reported will be identified.Methods and analysisStage I: (1) trial registry review to identify outcomes collected in glioma trials and (2) systematic review of qualitative literature exploring glioma patient and key stakeholder research priorities. Stage II: semi-structured interviews with glioma patients and caregivers. Outcome lists will be generated from stages I and II. Stage III: study team will remove duplicate items from the outcome lists and ensure accessible terminology for inclusion in the Delphi survey. Stage IV: a two-round Delphi process whereby the outcomes will be rated by key stakeholders. Stage V: a consensus meeting where participants will finalise the COS. The study team will identify the COS outcomes that can be patient-reported. Further research is needed to match patient-reported outcomes to available measures.Ethics and disseminationEthical approval was obtained (REF SMREC 21/59, Cardiff University School of Medicine Research Ethics Committee). Study findings will be disseminated widely through conferences and journal publication. The final COS will be adopted and promoted by patient and carer groups and its use by funders encouraged.PROSPERO registration numberCRD42021236979.

Mixed-methods process evaluation of a residence-based SARS-CoV-2 testing participation pilot on a UK university campus during the COVID-19 pandemic

BackgroundRegular testing for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is an important strategy for controlling virus outbreaks on university campuses during the COVID-19 pandemic but testing participation rates can be low. The Residence-Based Testing Participation Pilot (RB-TPP) was a novel intervention implemented at two student residences on a large UK university campus over 4 weeks. The aim of the pilot was to increase the frequency of asymptomatic SARS-CoV-2 saliva testing onsite. This process evaluation aimed to determine whether RB-TPP was implemented as planned and identify implementation barriers and facilitators.MethodsA mixed-methods process evaluation was conducted alongside the RB-TPP. Evaluation participants were students (opting in, or out of RB-TPP) and staff with a role in service provision or student support. Monitoring data were collected from the intervention delivery team and meeting records. Data were collected from students via online survey (n = 152) and seven focus groups (n = 30), and from staff via individual interviews (n = 13). Quantitative data were analysed descriptively and qualitative data thematically. Barriers and facilitators to implementation were mapped to the ‘Capability, Opportunity, Motivation–Behaviour’ (COM-B) behaviour change framework.ResultsFour hundred sixty-four students opted to participate in RB-TPP (98% of students living onsite). RB-TPP was implemented broadly as planned but relaxed social distancing was terminated early due to concerns relating to national escalation of the COVID-19 Delta variant, albeit testing continued. Most students (97.9%) perceived the period of relaxed social distancing within residences positively. The majority engaged in asymptomatic testing (88%); 46% (52% of testers) were fully compliant with pre-determined testing frequency. Implementation was facilitated by convenience and efficiency of testing, and reduction in the negative impacts of isolation through opportunities for students to socialise. Main barriers to implementation were perceived mixed-messages about the rules, ambivalent attitudes, and lack of adherence to COVID-19 protective measures in the minority.ConclusionsThis process evaluation identifies factors that help or hinder the success of university residence-based outbreak prevention and management strategies. RB-TPP led to increased rates of SARS-CoV-2 testing participation among students in university residences. Perceived normalisation of university life significantly enhanced student mental wellbeing. The complexity and challenge generated by multiple lines of communication and rapid adaptions to a changing pandemic context was evident.Trial registration numberUKAS 307727–02-01; Pre-results. ClinicalTrials.gov Identifier: NCT05045989; post-results (first posted, 16/09/21).Ethical approvalFaculty of Medicine & Health Sciences Research Ethics Committee, University of Nottingham (Ref: FMHS 96-0920)

What factors are important to whom in what context, when adults are prescribed hearing aids for hearing loss? A realist review protocol

IntroductionHearing aids are the gold standard treatment to help manage hearing loss. However, not everyone who needs them has them, and of those who do, a significant proportion of people...

How do diverse low-income and middle-income countries implement primary healthcare team integration to support the delivery of comprehensive primary health care? A mixed-methods study protocol from India, Mexico and Uganda

IntroductionAttainment of universal health coverage is feasible via strengthened primary health systems that are comprehensive, accessible, people-centred, continuous and coordinated. Having an adequately trained, motivated and equipped primary healthcare workforce...

Use of biochemical markers for diabetes prevention in the new decade

Abstract Use of biochemical markers for diabetes prevention in the new decade. There is established evidence that type 2 diabetes mellitus is preceded by a phase, during which there is a cluster of conditions including raised triglycerides and lowered high-density lipoprotein cholesterol, raised fasting glucose, high blood pressure and central obesity. This cluster of risk factors for type 2 diabetes mellitus, constitutes the metabolic syndrome (MetS). Therefore, there is need to screen for this syndrome among the population for the primary prevention of type 2 diabetes mellitus which is a global public health problem. Despite the high prevalence of type 2 diabetes in Mauritius, research work on MetS is scarce. This study was thus undertaken with the primary objective to determine the prevalence of MetS among the employees of a public educational institution in Mauritius. A cross-sectional study which involved randomly identified employees was conducted. The participants were requested to fill in a survey questionnaire, undergo biometric measurements (waist circumference and blood pressure) and venous blood sample collection in a fasting condition. The blood tests included the determination of glucose, triglyceride and cholesterol levels. The 2009 International Diabetes Federation criteria were used for the diagnosis of MetS. The presence of any 3 of 5 risk factors, raised triglycerides, raised glucose, lowered high-density lipoprotein cholesterol, high blood pressure and central obesity constitutes a diagnosis of metabolic syndrome. Ethical clearance was obtained from the Department of Medicine Research Ethics Committee of the University of Mauritius. The prevalence of MetS was found to be 20.1% (40 participants), in the overall population, 31.4% in men (22 out of 70) and 13.95% in women (18 out of 129). The determination of any association by means of the Chi square tests showed there was a significant association between gender and MetS (p &lt; 0.01). Educational level was also associated with the MetS (p &lt; 0.05). Logistic regression analysis confirmed t\he significant association between MetS with gender (p &lt; 0.01) where male gender was more associated with MetS than female. This study with the determination of the prevalence of the MetS among employees constituted the first step in the implementation of a structured workplace health intervention programme in Mauritius. We highlight the importance of workplace interventions with the involvement of a multi-disciplinary team of health professionals for the primary prevention of diabetes, through the screening for the MetS among employees.

The impact of community-based integrated HIV and sexual and reproductive health services for youth on population-level HIV viral load and sexually transmitted infections in Zimbabwe: protocol for the CHIEDZA cluster-randomised trial

Background: Youth have poorer HIV-related outcomes when compared to other age-groups. We describe the protocol for a cluster randomised trial (CRT) to evaluate the effectiveness of community-based, integrated HIV and sexual and reproductive health services for youth on HIV outcomes. Protocol: The CHIEDZA trial is being conducted in three provinces in Zimbabwe, each with eight geographically demarcated areas (clusters) (total 24 clusters) randomised 1:1 to standard of care (existing health services) or to the intervention. The intervention comprises community-based delivery of HIV services including testing, antiretroviral therapy, treatment monitoring and adherence support as well as family planning, syndromic management of sexually transmitted infections (STIs), menstrual health management, condoms and HIV prevention and general health counselling. Youth aged 16-24 years living within intervention clusters are eligible to access CHIEDZA services. A CRT of STI testing (chlamydia, gonorrhoea and trichomoniasis) is nested in two provinces (16 of 24 clusters). The intervention is delivered over a 30-month period by a multidisciplinary team trained and configured to provide high-quality, youth friendly services. Outcomes will be ascertained through a population-based survey of 18–24-year-olds. The primary outcome is HIV viral load &lt;1000 copies/ml in those living with HIV and proportion who test positive for STIs (for the nested trial). A detailed process and cost evaluation of the trial will be conducted. Ethics and Dissemination: The trial protocol was approved by the Medical Research Council of Zimbabwe, the Biomedical Research and Training Institute Institutional Review Board and the London School of Hygiene &amp; Tropical Medicine Research Ethics Committee. Results will be submitted to open-access peer-reviewed journals, presented at academic meetings and shared with participating communities and with national and international policy-making bodies. Trial Registration https://clinicaltrials.gov/: NCT03719521

Qualitative perspectives of teaching and learning in clinical skills laboratories in a developing country

IntroductionSimulation laboratories help students build a strong foundation of clinical competence in a stress-free environment. There is a paucity of research findings on this topic from nursing education institutions in resource-constrained countries. An evaluation study was therefore conducted at the Kamuzu College of Nursing in Malawi. The purpose of the study was to explore the experiences of students and educators on teaching and learning in a college-based skills laboratories.Data were collected using in-depth and focus group interviews with nurse educators (n = 6) and students (n = 45) respectively following semi-structured interview guides. Seven focus groups were conducted with students and six in-depth interviews with nurse educators. Data were managed using a MAXQDA software and analysed thematically. Ethical approval was obtained from the Human Research Ethics Committee, University of the Witwatersrand and the College of Medicine Research Ethics Committee, University of Malawi. The findings show that demonstrations, return demonstrations, practise sessions and resources contribute effectively to learning. Hasty demonstrations, limited practice time and inadequate resources, affect learning negatively. ConclusionIncreasing practise sessions, increasing staff and modernizing resources, can improve the quality of learning with respect to transitioning to practice and building students’ competence and confidence.

Managing responsive behaviours of care home residents with dementia during the COVID‐19 pandemic

BackgroundMost care home residents with dementia exhibit responsive behaviours including aggression, agitation and wandering (Cerejeira et al., 2012). Psychotropic drugs are often prescribed to manage responsive behaviours but contravene guidance as they increase the rate of strokes and death in people with dementia (Gustafsson et al., 2013). However, the use of psychotropic drugs for behaviour management may potentially increase during the COVID‐19 pandemic (Howard et al., 2020). Therefore, it is imperative to understand how responsive behaviours are managed to identify facilitators and barriers to implementing non‐pharmacological approaches.MethodDuring the Covid‐19 pandemic, 25 interviews were conducted with managers, nurses and care assistants from 21 care homes across Ireland. All participants provided written informed consent. Themes emerging from thematic analysis (Braun & Clarke, 2006) conceptualised understanding of how care home staff managed responsive behaviours during the COVID‐19 pandemic. Ethics approval was obtained from Lancaster University Faculty of Health and Medicine Research Ethics Committee (FHMREC20099).ResultResidents with dementia were perceived to be more depressed during the COVID‐19 pandemic due to the absence of family visits. However, care home staff reported that psychotropic drugs were not used more frequently for behaviour management than before the pandemic and that a person‐centred care approach was taken which involved supporting residents to participate in activities in smaller groups. Maintaining adequate staffing levels was challenging due to recruitment of nurses and care assistants from private care homes to acute public hospitals during the pandemic. Moreover, psychiatry and mental health support were difficult to access in rural regions of Ireland during COVID‐19 restrictions. Another emerging theme demonstrated that care assistants rarely contributed to equitable decision‐making, posing a barrier to implementing non‐pharmacological strategies to manage responsive behaviours.ConclusionThis study recommends that care homes should be prioritised in public health planning for Covid‐19, particularly to ensure optimal staffing levels and access to mental health support. In addition, care assistants should be provided with opportunities to contribute to decision‐making including case conferences. These recommendations will inform development of Department of Health policy and dementia care guidelines to facilitate implementation of non‐pharmacological strategies to manage responsive behaviours in dementia.

Assessment of ethical competence among clinical nurses in health facilities

Ethical competence in nursing practice helps clinical nurses to think critically, analyse issues, make ethical decisions, solve ethical problems and behave ethically in their daily work. Thus, ethical competence contributes to the promotion of high-quality care. However, studies on ethical competence in Malawi are scanty. The aim of this study was to explore ethical competence among clinical nurses in selected hospitals in Malawi. A cross-sectional survey was conducted in four selected hospitals in Malawi with a sample of 271 clinical nurses. Data were collected using self-administered questionnaires, which included a Moral Competence Scale for Home Care Nurses. Descriptive statistics and logistic regression were computed for the dataset using STATA version 12.0. The study protocol complied with all ethical requirements and was approved by the College of Medicine Research Ethics Committee under the University of Malawi. The clinical nurses in Malawi are ethically competent. However, there is a significantly high number (p < 0.05) of nurses 57% (n = 135) with low ethical competence. There was no significant association between respondents' demographic variables and level of ethical competence (p > 0.05). Three determinants of high ethical competence level (strong will, judgement skills and recognition of discrepancy of intention) were identified through a reduced model after stepwise logistic regression analysis. Furthermore, results show that indicators of ethical competence include caring, confidentiality and observance of nurses dressing code. The study has also confirmed that the Moral Competence Scale for Home Care Nurses is a reliable tool to assess ethical competence in low-resource settings. The majority of nurses who completed the survey had low ethical competence. However, clinical nurses with high ethical competence level are required to competently manage complex ethical challenges in health facilities. Strategies for enhancing ethical competence such as continuing ethics education, establishment of ethics committees and provision of supportive supervision are recommended to enable nurses in Malawi attain a high level of ethical competence.

Do CRP Levels Predict Severity in COVID-19 Hospitalized Patients?

Background: Coronavirus disease 2019 (COVID-19), has affected countless countries all over the world with rapidly increasing case fatality reports and a highly variable clinical course. Since the evolution of the clinical condition of these patients is difficult to forecast, early identification of prognostic indicators is an essential foundation to regulate treatment plans and promptly identify the severity of patients’ conditions.Method: A retrospective cohort study where the clinical data of patients with laboratory-confirmed COVID-19 infection were collected from El Obour Ain Shams University Specialized Hospital for Isolation records on admission from April 10, 2020 till July 30, 2020.we assessed the correlation between CRP level on admission with the severity of the COVID-19, the risk for ICU admission and the findings in CT chest in 276 patients.Results: Fever was the most common presenting symptom (total number 135; 41.7%), followed by cough (total number 133; 41.2%). High CRP levels were predictive of higher COVID-19 severity and ICU admission (p=0.000). Likewise, CRP levels were higher in patients with more chest affection as denoted by the CT chest findings (p=0.000).Conclusion: Serum CRP is a simple and effective prognosticator which casts light on potentially critical patients. Consequently, it can be used to reduce the mortality of patients.Funding Statement: None.Declaration of Interests: None.Ethics Approval Statement: Ethical approval or the current study protocol was obtained from Ain Shams University Faculty of Medicine Research Ethics Committee (REC) FWA 00017585.