Value and engagement : what can clinical trials learn from techniques used in not-for-profit marketing?

No funding has been received for this work.Peer reviewedPublisher PD

A mixed-methods study to investigate feasibility and acceptability of an early warning score for preterm infants in neonatal units in Kenya: results of the NEWS-K study

Preterm birth (\u3c 37 weeks gestation) complications are the leading cause of neonatal mortality. Early-warning scores (EWS) are charts where vital signs (e.g., temperature, heart rate, respiratory rate) are recorded, triggering action. To evaluate whether a neonatal EWS improves clinical outcomes in low-middle income countries, a randomised trial is needed. Determining whether the use of a neonatal EWS is feasible and acceptable in newborn units, is a prerequisite to conducting a trial. We implemented a neonatal EWS in three newborn units in Kenya. Staff were asked to record infants’ vital signs on the EWS during the study, triggering additional interventions as per existing local guidelines. No other aspects of care were altered. Feasibility criteria were pre-specified. We also interviewed health professionals (n = 28) and parents/family members (n = 42) to hear their opinions of the EWS. Data were collected on 465 preterm and/or low birthweight (\u3c 2.5 kg) infants. In addition to qualitative study participants, 45 health professionals in participating hospitals also completed an online survey to share their views on the EWS. 94% of infants had the EWS completed at least once during their newborn unit admission. EWS completion was highest on the day of admission (93%). Completion rates were similar across shifts. 15% of vital signs triggered escalation to a more senior member of staff. Health professionals reported liking the EWS, though recognised the biggest barrier to implementation was poor staffing. Newborn unit infant to staff ratios varied between 10 and 53 staff per 1 infant, depending upon time of shift and staff type. A randomised trial of neonatal EWS in Kenya is possible and acceptable, though adaptations are required to the form before implementation

Dietetics students’ construction of competence through assessment and placement experiences

Aim Competency standards are widely adopted as a framework to describe standards of performance required in the workplace. Little is known, however, about how students construct competence. This qualitative study aimed to explore how dietetics students ready to graduate construct the concept of competence and the role of assessment in developing professional competence. Methods A qualitative description was used to gather data from a convenience sample of students ready to graduate from universities with accredited dietetics programs across Australia (10 out of 15 at the time of the study). A total of 11 focus groups were conducted to explore perspectives of competence and experiences of ‘competency-based’ assessment. Data were audio-recorded, transcribed and analysed using a thematic analysis approach. Results A total of 81 (n = 81) participants across 10 universities representing 22% of total students participated in the focus groups. Themes revealed that: (i) there is no shared understanding of competence; (ii) current work placement experiences may not reflect current standards or workforce needs; (iii) assessment approaches may not fully support the development of competence; and (iv) the competent performance of supervising dietitians/clinical educators in the workplace influences the construction of competence. Conclusions There is a need to work towards a shared understanding of dietetic entry-level competence in the profession. ‘Work-based’ learning experiences may need to be modified to ensure students meet current competency standards. Practitioners involved in student supervision need to acknowledge the influential role they have in the development of the future workforce

e-Consent in UK academic-led clinical trials : current practice, challenges, and the need for more evidence

Peer reviewe

Evaluation of an enhanced training package to support clinical trials training in low and middle income countries (LMICs): experiences from the Born Too Soon Optimising Nutrition study

Training is essential before working on a clinical trial, yet there is limited evidence on effective training methods. In low and middle income countries (LMICs), training of research staff was considered the second highest priority in a global health methodological research priority setting exercise. Methods We explored whether an enhanced training package in a neonatal feasibility study in Kenya and India, utilising elements of the train-the-trainer approach, altered clinicians and researchers’ clinical trials knowledge. A lead “trainer” was identified at each site who attended a UK-based introductory course on clinical trials. A two-day in-country training session was conducted at each hospital. Sessions included the study protocol, governance, data collection and ICH-Good Clinical Practice (GCP). To assess effectiveness of the training package, participants completed questionnaires at the start and end of the study period, including demographics, prior research experience, protocol-specific questions, informed consent and ICH-GCP. Results Thirty participants attended in-country training sessions and completed baseline questionnaires. Around three quarters had previously worked on a research study, yet only half had previously received training. Nineteen participants completed questionnaires at the end of the study period. Questionnaire scores were higher at the end of the study period, though not significantly so. Few participants ‘passed’ the informed consent and ICH-Good Clinical Practice (GCP) modules, using the Global Health Network Training Centre pass mark of ≥ 80%. Participants who reported having prior research experience scored higher in questionnaires before the start of the study period. Conclusions An enhanced training package can improve knowledge of research methods and governance though only small improvements in mean scores between questionnaires completed before and at the end of the study period were seen and were not statistically significant. This is the first report evaluating a clinical trial training package in a neonatal trial in LMICs. Due to the Covid-19 pandemic, research activity was paused and there was a significant time lapse between training and start of the study, which likely impacted upon the scores reported here. Given the burden of disease in LMICs, developing high-quality training materials which utilise a variety of approaches and build research capacity, is critical

Feasibility of using an Early Warning Score for preterm or low birthweight infants in a low-resource setting: Results of a mixed-methods study at a national referral hospital in Kenya

© 2020 BMJ Publishing Group. All rights reserved. Introduction Fifteen million babies are born prematurely, before 37 weeks gestational age, globally. More than 80% of these are in sub-Saharan Africa and Asia. 35% of all deaths in the first month of life are due to prematurity and the neonatal mortality rate is eight times higher in low-income and middle-income countries (LMICs) than in Europe. Early Warning Scores (EWS) are a way of recording vital signs using standardised charts to easily identify adverse clinical signs and escalate care appropriately. A range of EWS have been developed for neonates, though none in LMICs. This paper reports the findings of early work to examine if the use of EWS is feasible in LMICs.Methods We conducted an observational study to understand current practices for monitoring of preterm infants at a large national referral hospital in Nairobi, Kenya. Using hospital records, data were collected over an 8-week period in 2019 on all live born infants born a

Parents, healthcare professionals and other stakeholders’ experiences of caring for babies born too soon in a low resource setting: A qualitative study of essential newborn care for preterm infants in Kenya

Objectives: Prematurity is the leading cause of global neonatal and infant mortality. Many babies could survive by the provision of essential newborn care. This qualitative study was conducted in order to understand, from a family and professional perspective, the barriers and facilitators to essential newborn care. The study will inform the development of an early warning score for preterm and LBW infants in low and middle income countries (LMICs).Setting: Single-centre, tertiary referral hospital in Nairobi, Kenya.Participants: Nineteen mothers and family members participated in focus group discussions and twenty key-informant interviews with professionals (healthcare professionals and policy-makers) were conducted. Focus group participants were identified via postnatal wards, the Newborn Unit and Kangaroo Mother Care Unit. Convenience and purposive sampling was used to identify professionals. Outcome measures: Understanding facilitators and barriers to provision of essential newborn care in preterm infants.Results: From 27 themes, three global themes emerged from the data; mothers’ physical and psychological needs, system pillars and kangaroo mother care. Conclusion: Meeting mothers’ needs in the care of their babies is important to mothers, family members and professionals, and deserves greater attention. Functioning system pillars depended on a standardised approach to care and low cost, universally applicable interventions are needed to support the existing care structure. Kangaroo Mother Care (KMC) was effective in both meeting mothers’ needs, supporting existing care structures and also provided a space for the resolution of the dialectical relationship between families and hospital procedures. Lessons learnt from the implementation of KMC could be applied to the development of an early warning score in LMICs

Home interventions and light therapy for treatment of vitiligo (HI-Light Vitiligo Trial): study protocol for a randomized controlled trial

Vitiligo is a condition resulting in white patches on the skin. People with vitiligo can suffer from low self-esteem, psychological disturbance and diminished quality of life. Vitiligo is often poorly managed, partly due to lack of high quality evidence to inform clinical care. We describe here a large, independent, randomised controlled trial (RCT) assessing the comparative effectiveness of potent topical corticosteroid, home-based hand-held narrowband ultraviolet B-light (NB-UVB) or combination of the two, for the management of vitiligo. Methods and Analysis The HI-Light Vitiligo Trial is a multi-centre, three-arm, parallel group, pragmatic, placebo-controlled RCT. 516 adults and children with actively spreading, but limited, vitiligo are randomised (1:1:1) to one of three groups: mometasone furoate 0.1% ointment plus dummy NB-UVB light, vehicle ointment plus NB-UVB light, or mometasone furoate 0.1% ointment plus NB-UVB light. Treatment of up to three patches of vitiligo is continued for up to 9 months with clinic visits at baseline, 3, 6 and 9 months and four post treatment questionnaires. The HI-Light Vitiligo Trial assesses outcomes included in the vitiligo core outcome set and places emphasis on participants’ views of treatment success. The primary outcome is proportion of participants achieving treatment success (patient-rated Vitiligo Noticeability Scale) for a target patch of vitiligo at 9 months with further independent blinded assessment using digital images of the target lesion before and after treatment. Secondary outcomes include time to onset of treatment response, treatment success by body region, percentage repigmentation, quality of life, time-burden of treatment, maintenance of response, safety, and within-trial cost effectiveness. Ethics and Dissemination Approvals were granted by East Midlands–Derby Research Ethics Committee (14/EM/1173) and the MHRA (EudraCT 2014-003473-42). The trial was registered 8th January 2015 ISRCTN (17160087). Results will be published in full as open access in the NIHR Journal library and elsewhere

A mixed-methods study to investigate feasibility and acceptability of an early warning score for preterm infants in neonatal units in Kenya: results of the NEWS-K study

Preterm birth (< 37 weeks gestation) complications are the leading cause of neonatal mortality. Early-warning scores (EWS) are charts where vital signs (e.g., temperature, heart rate, respiratory rate) are recorded, triggering action. To evaluate whether a neonatal EWS improves clinical outcomes in low-middle income countries, a randomised trial is needed. Determining whether the use of a neonatal EWS is feasible and acceptable in newborn units, is a prerequisite to conducting a trial. We implemented a neonatal EWS in three newborn units in Kenya. Staff were asked to record infants’ vital signs on the EWS during the study, triggering additional interventions as per existing local guidelines. No other aspects of care were altered. Feasibility criteria were pre-specified. We also interviewed health professionals (n = 28) and parents/family members (n = 42) to hear their opinions of the EWS. Data were collected on 465 preterm and/or low birthweight (< 2.5 kg) infants. In addition to qualitative study participants, 45 health professionals in participating hospitals also completed an online survey to share their views on the EWS. 94% of infants had the EWS completed at least once during their newborn unit admission. EWS completion was highest on the day of admission (93%). Completion rates were similar across shifts. 15% of vital signs triggered escalation to a more senior member of staff. Health professionals reported liking the EWS, though recognised the biggest barrier to implementation was poor staffing. Newborn unit infant to staff ratios varied between 10 and 53 staff per 1 infant, depending upon time of shift and staff type. A randomised trial of neonatal EWS in Kenya is possible and acceptable, though adaptations are required to the form before implementation

Silk garments plus standard care compared with standard care for treating eczema in children: a randomised controlled, observer blind, pragmatic trial (CLOTHES Trial)

Background The role of clothing in the management of eczema (syn. atopic dermatitis, atopic eczema) is poorly understood. This trial evaluated the effectiveness and cost-effectiveness of silk garments (in addition to standard care) for the management of eczema in children with moderate to severe disease. Methods and findings This was a parallel group randomised controlled, observer-blind trial. Children aged 1 to 15 years with moderate to severe eczema were recruited from secondary care and the community in five UK centres. Participants were allocated using on-line randomisation (1:1) to standard care, or standard care plus silk garments; stratified by age and recruiting centre. Silk garments were worn for 6 months. Primary outcome (eczema severity) was assessed at baseline, 2, 4 and 6 months, by nurses blinded to treatment allocation using the Eczema Area and Severity Index (EASI), which was log-transformed for analysis (intention-to-treat analysis). Safety outcome: number of skin infections. Three hundred children were randomised (26th Nov 2013 to 5th May 2015): 42% girls, 79% white, mean age 5 years. Primary analysis included 282/300 (94%) children (n = 141 in each group). The garments were worn more often at night than in the day (median of 81% of nights (25th to 75th centile 57% to 96%) and 34% of days (25th to 75th centile 10% to 76%)). Geometric mean EASI scores at baseline, 2, 4 and 6 months were 9·2, 6·4, 5·8, 5·4 for silk clothing and 8·4, 6·6, 6·0, 5·4 for standard care. There was no evidence of any difference between the groups in EASI score averaged over all follow up visits adjusted for baseline EASI score, age and centre (adjusted ratio of geometric means: 0·95, 95% CI 0·85 to 1·07). This confidence interval is equivalent to a difference of -1·5 to 0·5 in the original EASI scale units which is not clinically important. Skin infections occurred in 36/142 (25%) and 39/141 (28%) for silk clothing and standard care respectively. Even if the small observed treatment effect was genuine, the incremental cost per QALY was £56,881 in the base case analysis from an NHS perspective, suggesting that silk garments are unlikely to be cost-effective within currently accepted thresholds. Main limitations: whilst minimising detection bias, use of an objective primary outcome may have underestimated treatment effects. Conclusions Silk clothing is unlikely to provide additional benefit over standard care in children with moderate to severe eczema