Research Ethics Committee Research Articles

Towards painless and productive research relationships: reflections on study design by a researcher with chronic pain for participants with chronic pain

Building flexibility into the research design of a study allows for responsiveness to the embodied and fluctuating nature of participants’ chronic illnesses, which may be shaped, for instance, by flare-ups and periods of remission of acute pain. Whilst the methodology literature has, to some extent, considered how to accommodate the pain of research participants when designing a study, consideration of how methodological choices are responsive to the researcher's pain needs has not to date been foregrounded. From the perspective of a researcher with Ankylosing Spondylitis (AS), a form of inflammatory arthritis characterized by chronic pain, and Crohn's disease, a type of inflammatory bowel disease, characterized by stomach and joint pain, this paper provides insight into pain and researcher-participant relationships, from the perspective of a researcher in pain, designing a study to accommodate her own pain needs, as well as anticipating the needs of prospective participants in pain. This paper proposes the use of flexible, remote, and asynchronous research methods as ways to make studies inclusive for researchers living with pain, whilst fostering the most fruitful research relationships with participants who also live with pain, thereby moving towards a position of shared vulnerability. It also highlights the relative absence of the researcher's needs and possible vulnerability in ethics forms and considered by research ethics committees, in comparison to the needs and vulnerability of participants.

Evaluation of Health Awareness and Perceived Health Status among Men in Limpopo Province, South Africa

Background Men's health has emerged as an important public health concern requiring new healthcare interventions and increased resources. Knowledge about one’s own health influences engagement in preventive behaviours including health-seeking behaviour in men. Objective This study assessed health awareness and perceived health status among men in the Limpopo Province of South Africa. Methods A quantitative cross-sectional design was used to administer a self-administered questionnaire on 387 men conveniently available in randomly selected communities. The data were analysed using a Statistical Package for Social Science (SPSS) version 29.0. for windows. Descriptive statistics and inferential statistics were used. The significance level was set at 0.05, and all tests were two-tailed. Ethical approval was granted by the University of Venda Research ethics committee with reference number FHS/21/PH/26/1215, and permission was also obtained from community leaders. Results The majority (68%) of men knew that smoking poses a risk of developing lung cancer, and more than half (51%) knew it was not normal to experience pain when urinating. Health care workers were the main source of health formation, with about 75% of men receiving health care from these practitioners. More than half (54%) of men perceived their health status to be in good condition six (6) months before the study. Conclusion However, they lacked knowledge that too much alcohol was harmful to their health. The majority of men received health information from healthcare workers and perceived their health status to be in good condition six months before the study. There is a need for education about the impact of too much intake of alcohol on health.

Beyond ethical guidelines: upholding Aboriginal and Torres Strait Islander ethical governance in health and medical research. A scoping review.

To examine what ethics approvals are being sought for Aboriginal and Torres Strait Islander health and medical research, and to determine what proportion of this research upholds Aboriginal and Torres Strait Islander ethical governance via an Aboriginal and Torres Strait Islander community-controlled human research ethics committee (AHREC) by jurisdiction and funding body type. Scoping review of all original, peer-reviewed health and medical literature published over a 5-year period (January 2018 to December 2022). Extending on a previous review, the search tool LIt.search was used to access all literature relating to Aboriginal and Torres Strait Islander health and medical research. 589 eligible publications were included from the parent review, and a further 1703 publications were identified from the updated search. A total of 945 publications were included. A substantial number of ethics approvals were obtained from government-based ethics committees (394, 41.7%). More than half of the publications reported obtaining institutional ethics approval (514, 54.4%). Less than half (400, 42.3%) reported obtaining AHREC approval. Almost one-third of publications were on research that was conducted in states or territories where there is no AHREC (334, 35.3%). Publications did not always report obtaining AHREC approvals, including in jurisdictions where one operates. We found a concerning lack of Aboriginal and Torres Strait Islander ethical governance reported in health and medical research. Acknowledging that Aboriginal and Torres Strait Islander ethics guidelines and AHRECs were established due to harm caused to communities, these results suggest a high risk, with research not consistently being deemed safe, respectful and beneficial with appropriate AHREC ethics review and approval. We join calls for the establishment of AHRECs in all jurisdictions and nationally. Furthermore, we urge funding bodies and institutions to uphold requirements for Aboriginal and Torres Strait Islander ethical governance in research and funding agreements, as well as institutional policies and procedures.

How well are researchers applying ethical principles and practices in Aboriginal and Torres Strait Islander health and medical research? A cross-sectional study.

Describe perceptions of how well researchers conducting Aboriginal and Torres Strait Islander health and medical research apply ethical research practices. Cross-sectional online survey. Researchers who included Aboriginal and Torres Strait Islander people or their data in their projects, and current or past members (previous 5 years) of a human research ethics committee that assessed Aboriginal and Torres Strait Islander research. Researchers' engagement with 15 ethical research practices (on a 5-point Likert scale, poor to excellent). 561 participants (382 researchers [68.1%] and 179 human research ethics committee members [31.9%]) completed the survey. Across all research practices, a rating of excellent was least frequently endorsed, with the highest frequency being for employing Aboriginal and Torres Strait Islander team members (38 participants [6.8%]). A rating of poor was most common for enacting Indigenous data sovereignty and governance principles (156 participants [27.8%]). Aboriginal and Torres Strait Islander respondents had significantly lower odds of perceiving high levels of adherence to ethical principles than non-Aboriginal and Torres Strait Islander respondents for all ethical principles, except employing Aboriginal and Torres Strait Islander team members. In particular, Aboriginal and Torres Strait Islander participants had 65% lower odds of perceiving that researchers have high rates of adhering to disseminating results back to the community (odds ratio [OR], 0.35; 95% CI, 0.22-0.57), 56% lower odds of perceiving that researchers have high rates of adhering to engaging Aboriginal community in research implementation (OR, 0.44; 95% CI, 0.27-0.73), and 54% lower odds of perceiving that researchers have high rates of adhering to engaging Aboriginal community in developing research questions (OR, 0.46; 95% CI, 0.28-0.75). Researchers are not consistently implementing all ethical practices outlined in guidelines for research involving Aboriginal and Torres Strait Islander people. We call for commitment from researchers, institutions and funding bodies to address shortfalls, embed processes, and hold researchers accountable to Aboriginal and Torres Strait Islander people, communities and the principles and guidelines they have established.

Reported processes and practices of researchers applying for human research ethics approval for Aboriginal and Torres Strait Islander health research: a mixed methods study.

To examine self-reported practices for obtaining ethics approval and reflections on ethics application processes among researchers who have conducted Aboriginal and Torres Strait Islander health and medical research. Cross-sectional online survey. Australian-based researchers who conducted research that included Aboriginal and Torres Strait Islander people or their data. Results from a 74-item online survey that participants completed, which included questions on demographics, ethics processes, perceptions of engagement in Aboriginal and Torres Strait Islander research, and barriers to and enablers of conducting Aboriginal and Torres Strait Islander research. Of 553 eligible researchers who commenced the survey, 439 (79.4%) answered all of the questions and were included in the analysis. A total of 327 participants (74.5%) had obtained ethics approval from an Aboriginal human research ethics committee (AHREC), 254 (57.9%) had obtained multistate ethics approvals and 270 (61.5%) had not participated in ethics training specifically for Aboriginal and Torres Strait Islander research. Participants were significantly more likely to report being very or extremely confident in managing the ethics application process if they had ≥ 6 years of research experience, had participated in training, had obtained ethics approval from an AHREC, or dedicated > 50% of their time to Aboriginal and Torres Strait Islander research. Participants acknowledged the importance of ethics approval processes in improving research practices, however they identified time and costs as barriers. Aboriginal and Torres Strait Islander participants identified that ethics processes do not always uphold Indigenous approaches or methodologies. Processes for obtaining ethics approval for Aboriginal and Torres Strait Islander health and medical research do not meet contemporary research needs and would be strengthened by streamlining ethics application processes, reducing time and cost barriers, and enhancing cultural appropriateness. We join calls for the establishment of state-based AHRECs in every jurisdiction, and a national Aboriginal and Torres Strait Islander human research ethics committee to review cross-jurisdictional research.

Human research ethics committee processes and practices for approving Aboriginal and Torres Strait Islander health research: a mixed methods study.

To describe human research ethics committee (HREC) members' reports of: HREC membership structures; HREC processes for reviewing Aboriginal and Torres Strait Islander health and medical research; and experiences and perceptions of review operations. Cross-sectional 36-item survey and qualitative interviews with a subsample of survey participants. Current and past members (preceding five years) of HRECs who assessed Aboriginal and Torres Strait Islander research. Survey and interview results related to HREC structures, processes and functioning; challenges in review processes; and what is needed to improve ethical governance. 229 HREC members completed the survey and 13 were interviewed. Half the participants (115 of 221, 52%) reported having an Aboriginal and Torres Strait Islander representative position. Key issues identified related to assessment processes and resourcing, including burden on Aboriginal and Torres Strait Islander members, ability for Aboriginal and Torres Strait Islander HRECs to manage additional applications, lack of clarity around specific assessment criteria for general population studies, lack of cohesion across the application or complaints processes, and lack of resourcing and infrastructure to monitor ethical practice after approval. Aboriginal and Torres Strait Islander people carry an important role and burden in the review of applications and monitoring of health research. However, Aboriginal and Torres Strait Islander people are not presently involved in all aspects of ethical research governance within current HREC structures, including the review and monitoring of approved research. Standardised processes and guidelines that uphold Aboriginal and Torres Strait Islander rights and expert knowledges are required.

HER-SAFE study design: an open-label, randomised controlled trial to investigate the safety of withdrawal of pharmacological treatment for recovered HER2-targeted therapy-related cardiac dysfunction

IntroductionA quarter of breast cancers show human epidermal growth factor-2 (HER2) overexpression, where targeted therapy dramatically improves survival. However, cancer therapy-related cardiac dysfunction (CTRCD) occurs in up to 15% of patients. With the interruption of HER2 therapy, if necessary, and the initiation of heart failure therapy (HFT), HER2 CTRCD recovers in over 80% of cases. The need to continue HFT in ‘recovered’ HER2 CTRCD following completion of HER2 therapy is unclear and there are potential significant impacts on patient’s quality of life (QoL). The Randomised Controlled Trial for the Safety of Withdrawal of Pharmacological Treatment for Recovered HER2 Targeted Therapy Related Cardiac Dysfunction (HER-SAFE) aims to evaluate whether HFT can be safely withdrawn in non-high cardiovascular (CV) risk patients with ‘recovered’ HER2 CTRCD.Methods and analysisThis is a multicentre, open-label randomised controlled trial investigating whether withdrawal of HFT is non-inferior to continuation in non-high CV risk, breast cancer survivors with recovered HER2 CTRCD after cancer treatment completion. The primary endpoint is the incidence of guideline-defined cardiac dysfunction or clinical heart failure. Secondary endpoints include changes in cardiac blood biomarkers, cardiovascular magnetic resonance (CMR)-derived strain and tissue mapping and heart failure symptom questionnaires. The study will recruit 90 participants who will undergo serial clinical assessment over 12 months with advanced cardiovascular imaging (CMR scans with automated analysis at baseline, 6 and 12 months), cardiac biomarker measurement (six time points over 12 months), plus complete heart failure QoL and medication disutility questionnaires. This is the first multicentre study to address this significant clinical issue.Ethics and disseminationThis study was approved by the research ethics committee (London—London Bridge, 23/LO/0152). The results will be disseminated in peer-reviewed scientific journals.Trial registration numberNCT05880160.

Azithromycin to prevent acute lower respiratory infections among Australian and New Zealand First Nations and Timorese children (PETAL trial): study protocol for a multicentre, international, double-blind, randomised controlled trial

IntroductionAcute lower respiratory infections (ALRIs) remain the leading causes of repeated hospitalisations among young disadvantaged Australian and New Zealand First Nations and Timorese children. Severe (hospitalised) and recurrent ALRIs in the first years of life are associated with future chronic lung diseases (eg, bronchiectasis) and impaired lung function. Despite the high burden and long-term consequences of severe ALRIs, clinical, evidence-based and feasible interventions (other than vaccine programmes) that reduce ALRI hospitalisations in children are limited. This randomised controlled trial (RCT) will address this unmet need by trialling a commonly prescribed macrolide antibiotic (azithromycin) for 6–12 months. Long-term azithromycin was chosen as it reduces ALRI rates by 50% in Australian and New Zealand First Nations children with chronic suppurative lung disease or bronchiectasis. The aim of this multicentre, international, double-blind, placebo-containing RCT is to determine whether 6–12 months of weekly azithromycin administered to Australian and New Zealand First Nations and Timorese children after their hospitalisation with an ALRI reduces subsequent ALRIs compared with placebo. Our primary hypothesis is that children receiving long-term azithromycin will have fewer medically attended ALRIs over the intervention period than those receiving placebo.Methods and analysisWe will recruit 160 Australian and New Zealand First Nations and Timorese children aged <2 years to a parallel, superiority RCT across four hospitals from three countries (Australia, New Zealand and Timor-Leste). The primary outcome is the rate of medically attended ALRIs during the intervention period. The secondary outcomes are the rates and proportions of children with ALRI-related hospitalisation, chronic symptoms/signs suggestive of underlying chronic suppurative lung disease or bronchiectasis, serious adverse events, and antimicrobial resistance in the upper airways, and cost-effectiveness analyses.Ethics and disseminationThe Human Research Ethics Committees of the Northern Territory Department of Health and Menzies School of Health Research (Australia), Health and Disability Ethics Committee (New Zealand) and the Institute National of Health-Research Technical Committee (Timor-Leste) approved this study. The study outcomes will be disseminated to academic and medical communities via international peer-reviewed journals and conference presentations, and findings reported to health departments and consumer-based health organisations.Clinical trial registrationAustralia New Zealand Clinical Trial Registry ACTRN12619000456156.

Multicentre, 26-week, open-label phase 2 trial of the JAK inhibitor filgotinib in Behçet’s disease, idiopathic inflammatory myopathies and IgG4-related disease: DRIMID study protocol

IntroductionResearch into novel therapies for rare, immune-mediated inflammatory diseases (IMIDs) faces significant challenges, including small patient populations, complex clinical trial design and difficulties in patient recruitment. Patients with Behçet’s disease (BD), idiopathic inflammatory myopathies (IIM) and IgG4-related disease (IgG4-RD) typically undergo treatment involving prolonged administration of high-dose glucocorticoids and immunosuppressants. Both are associated with an increased risk of infection. Additionally, glucocorticoids carry long-term toxicity risks. Thus, there is an urgent need to develop more targeted and effective anti-inflammatory treatments. Given the activation of the type 1 interferon pathway in BD, IIM and IgG4-RD, inhibition of the Janus kinase (JAK) STAT pathway emerges as a promising therapeutic strategy. The Drug Rediscovery in IMIDs (DRIMID) consortium aims to conduct a prospective pilot basket trial to investigate the effects of filgotinib, a JAK1 preferential inhibitor approved for ulcerative colitis and rheumatoid arthritis, on disease activity, quality of life and safety in patients with refractory BD, IIM and IgG4-RD.Methods and analysisIn this investigator-initiated, multicentre, open-label phase 2 study, up to 60 patients with rare IMIDs will be enrolled for a 26-week treatment period with filgotinib 200 mg once daily. The trial consists of two stages, each involving a consecutively treated cohort of up to 20 patients per disease. An interim analysis is conducted between these stages, where the trial will proceed only in diseases showing potential effectiveness. Baseline, 3-month and 6-month assessments will include data on quality of life, disease activity, corticosteroid toxicity and biomarkers. The coprimary endpoints are disease activity and quality of life across and within each disease.Ethics and disseminationThe study received approval from the Medical Research Ethics Committee in Utrecht, Netherlands. A Data Safety Monitoring Board has been established to monitor the trial’s safety and progress.Trial registration numberNCT06285539.

Prevalence OF HPV IN a Peruvian Healthcare Network: A Descriptive Cross-Sectional Study.

Human papillomavirus (HPV) infection is a common sexually transmitted infection often associated with cancer development. This study aimed to estimate the prevalence of HPV in women receiving care at the AUNA healthcare network in Peru. We conducted an observational, descriptive, cross-sectional, retrospective study. A de-identified database of HPV-positive women who underwent the BD Onclarity™ HPV Assay between December 2018 and December 2021 at Auna clinics was analyzed. The database contained information regarding age, city, and HPV type. High-risk HPV types were analyzed individually (16, 18, 31, 45, 51, 52) and pooled [P1 (33, 58), P2 (56,59,66), and P3 (35,39,68)]. The study was approved by an independent research ethics committee in Peru. Of 68,714 women included in the study, the HPV prevalence was 14.21% (N = 9765, 95%CI:13.95%-14.47%). The highest prevalence was detected in Piura (16.85%, 95%CI:15.40%-18.38%), where HPV-51, HPV-52, HPV-P1, HPV-P2, and HPV-P3 were most common compared to other Peruvian cities included in the study. In Arequipa, the prevalence was the lowest (13.58%, 95%CI:12.38%-14.85%), but the percentage prevalence of HPV-16 was the highest compared to other cities. The prevalence of multiple HPV infections was 2.88% (N = 1981, 95%CI:2.76%-3.01%), with most of them co-presenting two types of HPV (N = 1522). The most frequent co-occurrences were P2 and P3, P2 and 52, and P2 and 16. Among HPV-positive women, the mean age was 41.31 years (±9.48) and 25.29% were in the 31-35 years group. HPV-P2 was the most frequent in all age groups except in the 65-72 years group, where HPV-P3 was the most common. HPV prevalence was shown to be highest in Piura, with the most prevalent types being HPV-16, HPV-52, and HPV-P2 (HPV-56, -59, -66). HPV infection was found to be more frequent among women in the 31-35 years age group.

An investigator-blinded, 24-month, parallel-group, non-inferiority study to compare aesthetic restorations in primary anterior teeth in a paediatric dental clinic: study protocol for a randomised controlled trial

IntroductionChildren who suffer from severe caries in childhood may have negative impacts on the growth, development, nutritional problems and quality-of-life problems related to the oral health of the child and their family. There are no studies that have compared rehabilitative techniques of primary anterior teeth regarding patient-centred outcomes and even longevity of the restoration. Thus, this project aims to evaluate the effectiveness of restorative treatment of anterior primary teeth with monochromatic composite resin in single insertion through polyvinyl crowns, after selective removal of carious tissue compared with the effectiveness of conventional restoration.Methods and analysisThis study proposes to conduct a randomised clinical trial, composed of a sample of 194 deciduous central and lateral incisors with active cavitated lesions, simplified International Caries Detection and Assessment System (ICDAS) C+ score (active and extensive stage caries: ICDAS 5 and 6), with involvement of more than two surfaces. This sample will be divided into two experimental groups, both with selective removal of carious tissue: a group in which conventional restoration will be performed using opaque resins, and another group with monochrome resin with chameleon effect and polyvinyl crowns. The explanatory variables—gender, age, toothbrushing, use of fluoridated toothpaste and dental floss, and socioeconomic status—will be collected through a questionnaire with open questions. The progression of caries lesions after 24 months of follow-up will be considered as the primary outcome. Secondary outcomes will include tooth survival, longevity of restoration, quality of life, perception and satisfaction of the participants’ parents/guardians.Ethics and disseminationThis protocol has been approved by the Human Research Ethics Committee of Universidade Metropolitana de Santos (protocol number: 6.019.297. Approved 24 April 2023). Results will be submitted to international peer-reviewed journals and presented at international conferences.Trial registration numberNCT05875064.

The effectiveness and risks of Treating people with Idiopathic Pulmonary fibrosis with the Addition of Lansoprazole (TIPAL): study protocol for a randomised placebo-controlled multicentre clinical trial.

Idiopathic pulmonary fibrosis (IPF) is a chronic progressive fibrotic lung disease frequently complicated by gastro-oesophageal reflux disease. Although several observational studies and a pilot study have investigated the role of proton pump inhibitors (PPIs) in IPF, their efficacy is unknown and there is much debate in international IPF guidelines on their use. We aim to undertake an adequately powered double-blind placebo-controlled randomised multicentre clinical trial to assess the change in forced vital capacity (FVC), cough and other important patient-reported outcomes, following 12-month therapy with PPIs in people with IPF. A total of 298 patients with IPF diagnosed by a multidisciplinary team according to international guidelines who are not receiving PPIs will be enrolled. Patients are randomised equally to receive two capsules of lansoprazole or two placebo capsules, two times per day for 12 months. The primary outcome for the trial is change in FVC, measured at home, between the first week and last week of the study period. Secondary assessments include cough frequency (in a subgroup) measured using the VitaloJAK cough monitor, the King's Brief Interstitial Lung Disease questionnaire, the Raghu Scale for Pulmonary Fibrosis, Medical Research Council dyspnoea score, EQ-5D-5L, Leicester Cough Questionnaire, modified DeMeester reflux symptoms questionnaire and opportunistically captured routine lung function measurements. High-resolution CT scoring will be undertaken in a subgroup. The trial is designed to determine whether treating people with IPF with lansoprazole will reduce the reduction in FVC over a year. The COVID-19 pandemic required the study to be undertaken as a remote trial. This study received ethical approval from the East of England Cambridgeshire and Hertfordshire Research Ethics Committee (reference 20/EE/0043; integrated research application system number 269050). Trial results will be published in a peer-reviewed journal upon completion. ISRCTN13526307; ClinicalTrials.gov NCT04965298.

The Effect of Weight Loss by Acupuncture Therapy on Fecal Microbiota Composition in Obese Female Patients

Objective: The aim of this study was to investigate the possible effects of acupuncture therapy on anthropometric and biochemical parameters, as well as on gut microbiota in obese females and to describe any changes that occurred. Method: This prospectively designed study was approved by the xxx Faculty of Medicine Ethics Committee for Research on Medicine and Non-Medical Devices, dated 11.04.2019 and numbered 2019/1820. This study was performed on voluntary obese female individuals who applied to xxx Center between May 2019 and December 2019 to lose weight. The study was conducted with 15 individuals who displayed the following inclusion criteria: aged 34–45, female gender, body mass index (BMI)≥30 kg/m2, not taking antibiotic medication in the last six months, no known systemic disease (diabetes mellitus, hypertension, chronic kidney disease, etc.), no smoking or alcohol use, not pregnant, not using supplements such as probiotics, antioxidants, vitamins, etc., and not using systemic drugs. Results: The ages and anthropometric and biochemical measurements of a total of 15 individuals (acupuncture group, n=9; diet group, n=6) included in the study as a consequence of two different treatment methods are summarized in Table 1. There was no significant difference observed in pre-treatment (0 month) levels of age, body weight, BMI, waist circumference, glucose, insulin, and HOMA-IR of the groups (p>0.05). Conclusion: Considering the detected results of relationship between PA level sleep quality and well-being in the present study, we suggest that regular and adequate PA in every period of life, especially such a sedentary life process may have positive impacts on the sleep quality, energy and well-being, and reduce conditions such as depression and anxiety for individuals with DM.

Relationships of maternal hemodynamics in the third trimester with fetal umbilical artery doppler indices, estimated fetal weight and birth weight in women with and without congenital heart disease.

To compare differences in maternal hemodynamics, measured non-invasively by impedance cardiography and mean arterial blood pressure (MAP)-at rest and with high-intensity exercise-between pregnant women with corrected congenital heart disease (CHD) and low-risk (LR) pregnant controls, and to correlate these findings with umbilical artery Doppler in the third trimester, estimated fetal weight (EFW) and birth weight (BW). Prospective longitudinal study with hemodynamic exercise studies and fetal ultrasound between 30 and 34 weeks' gestation. Approval was obtained from London South East Research Ethics Committee. There were no differences in heart rate (HR), stroke volume (SV), or cardiac output (CO) at rest between the two groups. HR at peak exercise was significantly lower in the CHD group, and MAP was significantly higher at rest and immediately after exercise. In the CHD group there was a significant association between CO at peak exercise and BW. In the LR group there was a significant association between peak CO with exercise and the abdominal circumference/EFW ratio and between HR at rest and BW. There were no differences in the Doppler indices between groups. There was a statistically significant association between uterine artery Doppler pulsatility index and BW in the LR group, but not in the CHD group. There was no difference between Doppler indices in the third trimester between a LR population and a population with corrected CHD with no or minimal functional impairment. This suggests that factors other than defective placentation may be causing the lower BW in the CHD population.

NIFTy: near-infrared fluorescence (NIRF) imaging to prevent postsurgical hypoparathyroidism (PoSH) after thyroid surgery—a phase II/III pragmatic, multicentre randomised controlled trial protocol in patients undergoing a total or completion thyroidectomy

IntroductionPostsurgical hypoparathyroidism (PoSH) is an iatrogenic condition that occurs as a complication of several different procedures with thyroid surgery being the most common. PoSH has significant short- and long-term morbidities....

2785 Protocol for a feasibility randomised controlled trial of the OUTDOOR mobility intervention for older adults after hip fracture

Abstract Introduction A high proportion of patients do not regain outdoor mobility after hip-fracture. Rehabilitation explicitly targeting outdoor mobility is needed to enable older adults to resume activities that they value most. The aim of this study is to determine the feasibility of a randomised, controlled trial intended to assess the clinical and cost-effectiveness of an intervention enabling recovery of outdoor mobility post hip-fracture (the OUTDOOR intervention). Method OUTDOOR is a multi-centre, parallel group, randomised, controlled, feasibility trial. Adults 60 years and older, admitted to hospital and planned discharge to home; with self-reported outdoor mobility three-months pre-fracture, surgically treated for hip fracture, who are able to consent and participate, are eligible. Individuals requiring two or more people to support mobility upon discharge are excluded. Screening and consent (or consent to contact) will take place in hospital. Baseline assessment and randomisation will follow discharge. Participants will receive usual care (physiotherapy, occupational therapy), or usual care plus the OUTDOOR intervention. OUTDOOR intervention includes a goal-orientated outdoor mobility programme, therapist-led motivational dialogue supported by a past-patient led videos sharing recovery experiences; and support to transition to independent recovery. Therapists delivering the OUTDOOR intervention will receive training in motivational interviewing, and behaviour change techniques. Patient reported outcome measures—health-related quality of life, daily activities, pain, community mobility, falls related self-efficacy, resource use, and readmission; will be collected at baseline, 6-weeks, 12-weeks, and 6-months (if enrolled early in the trial) post-randomisation. Exercise adherence and intervention acceptability will be collected. Subset of 20 participants will support accelerometery data collection for 10 days at each time point. Trial received approval from East of England—Essex Research Ethics Committee (REF: 23/EE/0246) and the Health Research Authority. Findings will be disseminated to patients, the public, health professionals and researchers through publications, presentations, and social media. Trial registered at ISRCTN16147125.

Exercise-based cardiac rehabilitation for patients with atrial fibrillation receiving catheter ablation: protocol for a feasibility randomised controlled trial (RCT) with embedded process evaluation

IntroductionAtrial fibrillation (AF) affects approximately 2.5% of the UK population, with a risk of 1 in 3–5 individuals after the age of 45 years. The global prevalence has risen sharply...

Protocol for a randomised ‘screen-and-treat’ Helicobacter pylori eradication trial in 14–18-years-old adolescents residing in three regions of Chile: effectiveness and microbiological host implications

IntroductionGastric cancer is a major global health concern, being the final stage of a long-term process, primarily associated with Helicobacter pylori (H. pylori) infection. Early childhood acquisition of H. pylori...

Human versus Analogue Insulin for Youth with Type 1 Diabetes in Low-Resource Settings (HumAn-1): protocol for a randomised controlled trial

IntroductionLong-acting insulin analogues are the standard of care for people with type 1 diabetes (T1D) in high-income countries but remain largely inaccessible and understudied in low-resource settings. In settings where...

Observational study protocol: the faecal microbiome in the acute stage of new-onset paediatric type 1 diabetes in an Irish cohort

IntroductionType 1 diabetes (T1D) is an autoimmune-mediated disorder caused by the destruction of pancreatic beta cells. Although there is an underlying genetic predisposition to developing T1D, the trigger is multifactorial...