Local Research Staff Research Articles

What Happens When you Ask for Feedback? Anticipating and Addressing Challenges Can Be Effective for Eliciting Parents' Views About Their Critically Ill Child's Retrieval to Paediatric Intensive Care.

User feedback is an important element of health-service evaluation and can be used to improve services but can be difficult to obtain, particularly in acute care situations. As part of a national study, we explored stakeholders' perspectives on paediatric critical care retrieval processes through questionnaires and interviews. Obtaining feedback in a highly charged, stressful and busy paediatric intensive care unit (PICU) environment is fraught with difficulties so we aimed to optimise each stage of data collection by being both proactive and reactive. Patient and public involvement occurred throughout and engagement with sites and supporting local research staff to approach and recruit families were prioritised. High-quality study materials were developed to reduce local staff burden and promote and maintain study awareness. We describe strategies used and what worked/did not work. We suggest approaches for optimising elicitation of parents' experiences in difficult circumstances, highlighting the importance of engagement and commitment of PICU staff.

Open urethroplasty versus endoscopic urethrotomy for recurrent urethral stricture in men: the OPEN RCT.

Men who suffer recurrence of bulbar urethral stricture have to decide between endoscopic urethrotomy and open urethroplasty to manage their urinary symptoms. Evidence of relative clinical effectiveness and cost-effectiveness is lacking. To assess benefit, harms and cost-effectiveness of open urethroplasty compared with endoscopic urethrotomy as treatment for recurrent urethral stricture in men. Parallel-group, open-label, patient-randomised trial of allocated intervention with 6-monthly follow-ups over 24 months. Target sample size was 210 participants providing outcome data. Participants, clinicians and local research staff could not be blinded to allocation. Central trial staff were blinded when needed. UK NHS with recruitment from 38 hospital sites. A total of 222 men requiring operative treatment for recurrence of bulbar urethral stricture who had received at least one previous intervention for stricture. A centralised randomisation system using random blocks allocated participants 1 : 1 to open urethroplasty (experimental group) or endoscopic urethrotomy (control group). The primary clinical outcome was control of urinary symptoms. Cost-effectiveness was assessed by cost per quality-adjusted life-year (QALY) gained over 24 months. The main secondary outcome was the need for reintervention for stricture recurrence. The mean difference in the area under the curve of repeated measurement of voiding symptoms scored from 0 (no symptoms) to 24 (severe symptoms) between the two groups was -0.36 [95% confidence interval (CI) -1.78 to 1.02; p = 0.6]. Mean voiding symptom scores improved between baseline and 24 months after randomisation from 13.4 [standard deviation (SD) 4.5] to 6 (SD 5.5) for urethroplasty group and from 13.2 (SD 4.7) to 6.4 (SD 5.3) for urethrotomy. Reintervention was less frequent and occurred earlier in the urethroplasty group (hazard ratio 0.52, 95% CI 0.31 to 0.89; p = 0.02). There were two postoperative complications requiring reinterventions in the group that received urethroplasty and five, including one death from pulmonary embolism, in the group that received urethrotomy. Over 24 months, urethroplasty cost on average more than urethrotomy (cost difference £2148, 95% CI £689 to £3606) and resulted in a similar number of QALYs (QALY difference -0.01, 95% CI -0.17 to 0.14). Therefore, based on current evidence, urethrotomy is considered to be cost-effective. We were able to include only 69 (63%) of the 109 men allocated to urethroplasty and 90 (80%) of the 113 men allocated to urethrotomy in the primary complete-case intention-to-treat analysis. The similar magnitude of symptom improvement seen for the two procedures over 24 months of follow-up shows that both provide effective symptom control. The lower likelihood of further intervention favours urethroplasty, but this had a higher cost over the 24 months of follow-up and was unlikely to be considered cost-effective. Formulate methods to incorporate short-term disutility data into cost-effectiveness analysis. Survey pathways of care for men with urethral stricture, including the use of enhanced recovery after urethroplasty. Establish a pragmatic follow-up schedule to allow national audit of outcomes following urethral surgery with linkage to NHS Hospital Episode Statistics. Current Controlled Trials ISRCTN98009168. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 61. See the NIHR Journals Library website for further project information.

The MOMENTUM study: Putting the ‘Three Delays’ to work to evaluate access to emergency obstetric and neonatal care in a remote island community in Western Kenya

ABSTRACT Despite worldwide improvements in maternal and infant mortality, mothers and babies in remote, low-resource communities remain disproportionately vulnerable to adverse health outcomes. In these settings, delays in accessing emergency care are a major driver of poor outcomes. The ‘Three Delays’ model is now widely utilised to conceptualise these delays. However, in out-of-hospital contexts, operational and methodological constraints present major obstacles in practically quantifying the ‘Three Delays’. Here, we describe a novel protocol for the MOMENTUM study (Monitoring of Maternal Emergency Navigation and Triage on Mfangano), a 12-month cohort design to assess delays during obstetric and neonatal emergencies within the remote villages of Mfangano Island Division, Lake Victoria, Kenya. This study also evaluates the preliminary impact of a community-based intervention called the ‘Mfangano Health Navigation’ programme. Utilising participatory case audits and contextually specific chronological reference strategies, this study combines quantitative tools with deeper-digging qualitative inquiry. This pragmatic design was developed to empower local research staff and study participants themselves as assets in unravelling the complex socio-economic, cultural, and logistical dynamics that contribute to delays, while providing real-time feedback for locally driven intervention. We present our methods as an adaptive framework for researchers grappling with similar challenges across fragmented, rural health landscapes.

Oral curcumin in elective abdominal aortic aneurysm repair: a multicentre randomized controlled trial.

Curcumin, a popular herbal supplement from the plant turmeric, has prevented ischemic reperfusion and toxin-induced injury in many animal studies and a single-centre randomized human trial. We sought to test whether perioperative oral curcumin (compared with placebo) affects the inflammatory response and risk of postrepair complications after elective abdominal aortic aneurysm repair in humans. We conducted a parallel-group, randomized, placebo-controlled trial of patients from 10 hospitals in Canada who were scheduled to undergo elective repair of an unruptured abdominal aortic aneurysm (November 2011 to November 2014). Patients in the treatment group received perioperative oral curcumin (2000-mg doses 8 times over 4 d). Patients, health care providers and local research staff were unaware of the treatment assignment. The primary outcomes were median concentrations of 4 bio markers indicating injury and inflammation (postoperative urine interleukin-18 and perioperative rise in serum creatinine, plasma N-terminal pro-B-type natriuretic peptide and plasma high-sensitivity C-reactive protein). Baseline characteristics were similar in the 2 groups (606 patients overall; median age 76 yr). More than 85% of patients in each group took more than 80% of their scheduled capsules. Neither curcumin nor placebo significantly affected any of the 4 biomarkers (p > 0.05 for all comparisons). Regarding the secondary outcomes, there was a higher risk of acute kidney injury with curcumin than with placebo (17% v. 10%, p = 0.01), but no between-group difference in the median length of hospital stay (5 v. 5 days, p > 0.9) or the risk of clinical events (9% v. 9%, p = 0.9). Curcumin had no beneficial effects when used in elective abdominal aortic aneurysm repair. These findings emphasize the importance of testing turmeric and curcumin before espousing their health benefits, as is currently done in the popular media. ClinicalTrials.gov, no. NCT01225094.

The Young Women\u2019s Health CoOp in Cape Town, South Africa: Study protocol for a cluster-randomised trial for adolescent women at risk for HIV

BackgroundSouth Africa remains the global epicentre of HIV infection, and adolescent women have the highest incidence of HIV in the country. South Africa also has high rates of alcohol and other drug (AOD) use, violence, and gender inequality. Violence converges with AOD use, gender inequities and other disparities, such as poverty, to increase sexual risk and poor educational attainment for adolescent women. This study seeks to test the efficacy of peer recruitment and cofacilitation of the Young Women’s Health CoOp (YWHC), a comprehensive gender-focused intervention to reduce HIV risk behaviours and increase the uptake of HIV counselling and testing (HCT) among out-of-school, adolescent women who use AODs. The YWHC is facilitated by local research staff and supported by peers.MethodsThis cluster-randomised trial is enrolling participants into two arms: a control arm that receives standard HCT, and an intervention arm that receives the YWHC. Participants are enrolled from 24 economically disadvantaged communities in Cape Town, South Africa. These geographically distinct communities serve as clusters that are the units of randomisation. This study uses adolescent peer role models and research field staff to recruit marginalised adolescent women. At baseline, participants complete a questionnaire and biological testing for HIV, recent AOD use, and pregnancy. The core intervention is delivered in the month following enrollment, with linkages to health services and educational programmes available to participants throughout the follow-up period. Follow-up interviews and biological testing are conducted at 6 and 12 months post enrollment.DiscussionThe study findings will increase knowledge of the efficacy of a comprehensive HCT, gender-focused programme in reducing AOD use, victimisation, and sexual risk behaviour and increase uptake services for out-of-school, adolescent women who use AODs. The trial results could lead to wider implementation of the YWHC for vulnerable adolescent women, a key population often neglected in health services.Trial registrationTrial registration no: NCT02974998, November 29, 2016.

Community and research staff collaboration for development of materials to inform microbicide study participants in Africa.

IntroductionClinical trials of new vaginal products require careful communication with participants about trial requirements. Most microbicide trials have been multi-site studies conducted among women in sub-Saharan Africa, where literacy levels and understanding of scientific methods differ from those designing and conducting the trials. Microbicide trials require women to insert objects in their vagina and ensure they are present in the vagina during sex. For many women, this is a novel behaviour. These behaviours take place within the context of clinical trial participation, which is an additional novelty. Research teams must develop informational materials to help participants understand the clinical trial and input from local research staff and community members can improve the content and format of these materials.MethodsThis paper discusses the development of illustrated materials developed for microbicide trial participants, presenting examples from two studies. In both studies, research staff and community advisory groups collaborated to review and revise materials.ResultsCollaborative efforts revealed insights about how to convey information about clinical trial participation and microbicide use. These insights highlighted realities of the local context, details that might be misunderstood, illustrations of a sensitive nature and concerns about blood testing. In particular, information about blood testing and product use instructions required careful consideration. Although the research team anticipated needing advice on how best to convey information on these topics to participants, some aspects of potential participant concerns about these topics were also new to the research team. Community advisors and local research staff suggested better ways to convey this information, and provided guidance on how to use the materials.ConclusionsThe collaboration served to develop informational materials for microbicide trial participants. Furthermore, staff gained a better understanding of issues and concerns that could influence trial participation. A collaborative engagement process can provide important insights into local culture and knowledge beyond what is needed for development of clinical trial participant information materials. Research teams should be sensitive to this possibility, avail themselves of information and take appropriate action.

Challenges to clinical research in a rural african hospital; a personal perspective from Tanzania.

This article is based on a talk given at the Japanese Society for Tropical medicine Annual Meeting in 2014. The severe febrile illness study was established in 2005. The aim of the project was to define the aetiology of febrile disease in children admitted to a hospital in Tanzania. Challenges arose in many areas: Study design: An initial plan to recruit only the severely ill was revised to enroll all febrile admissions leading to a more comprehensive dataset but much increased costs. Operationally a decision was made to set up a paediatric acute admissions unit (PAAU) in the hospital to facilitate recruitment and to provide appropriate initial care in line with perceived ethical obligations. This had knock on effects relating to the responsibilities that were taken on but also some unexpected positive outcomes. Study personnel: Local research staff were sometimes called upon to make up temporary shortfalls in the hospital staffing. Lack of staff made it impossible to recruit patients around the clock, seven days a week creating the challenge of ensuring representative sampling. Quality control: Studies based on clinical examination create unique quality control challenges—how to ensure that clinical staff are examining in a systematic and reproducible way. We designed a sub-study to both explore this and improve quality. Summary: Setting up clinical research projects is severely resource poor settings creates many challenges including those of an operational, technical and ethical nature. Whilst there are no ‘right answers’ an awareness of these problems can help overcome them.