Search results for: randomised controlled trial

Authors: R. Botrugno, S Basyuni, G. Nugent, I. Jenkyn, A. Ferro, H. Bennett, C. Hjalmarsson, J. Chu, V. Santhanam

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This trainee led randomised controlled trial (RCT) aims to assess various outcomes for resorbable versus non-resorbable sutures for traumatic lacerations to the face. Within this trial of resorbable versus non-resorbable sutures for traumatic lacerations of the face (TORNFace), patient recruitment was facilitated by trainees who were employed at an NHS University Teaching Hospital in the United Kingdom. The trainees received appropriate training prior to recruiting patients for the trial. This included the completion of a national research e-learning module and face-to-face training that was provided locally. The locally delivered training provided an understanding of the eligibility criteria for the trial and the consent process. Existing trainee skills were utilised involving clinical photography to record baseline data and delivering the intervention based on the treatment arm selected. Eligible patients who required primary closure of traumatic lacerations of the face were randomised into one of two treatment arms. These comprised of resorbable (vicryl rapide) or non-resorbable sutures (ethilon). Primarily the cosmetic outcome was assessed. Secondary outcomes included: complications rates, health care economics, and patient-reported outcomes. Remote follow-up of recruited patients utilised photographs of the facial laceration which had received the intervention. These took place at 1 week, 3 months and 6 months post-intervention. This study aims to demonstrate an example of trainee-led research within the specialty of oral and maxillofacial surgery. The available data for the randomised controlled trial will also be presented.

Keywords: laceration, suture, trauma, trial

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Authors: Phomid Techi, L. N. Padmasini, Mohan Mathew

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Objective: To evaluate the effectiveness of co-parent support on the duration of exclusive breastfeeding by a randomized control trial. Introduction: The current rates of exclusive breastfeeding for 6 months in India is 46% (NFHS3 2008.). The purpose of the study is to evaluate the effectiveness of co-parenting support on duration of exclusive breastfeeding in primi mothers. Design: RCT: Willing parents of healthy TAGA babies born in our hospital were explained about the study purpose and randomly assigned to either trial or control group. The control group was given the usual care. The intervention group received usual care and in addition the trial intervention. Follow-up data was collected at the end of 6 mon. Intervention: Face to face 30-minute discussion in post partum unit on breast feeding benefits, techniques, and problem-solving information followed up by phone calls to mother every 4 weeks to answer questions/concerns. Outcome measures: Duration of exclusive breastfeeding Baseline demographic variables were measured. Results: After obtaining IEC approval a total of 100 couples were recruited, 100 is each group. In the intervention group, the rate of exclusive breastfeeding was 97.2% while in the control group it was 64% (p-value 0.00). Conclusion: Co-parenting support has an important role in promoting exclusive breastfeeding.

Keywords: co-parenting, exclusive breastfeeding, developing nation, randomised control trial

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Authors: Laila Khawaja

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In recent years, an increasing emphasis has been placed on measuring program implementation, in part because of the great variability in how complex interventions are delivered in real-life settings. There is an increased awareness that while conducting process evaluations, one should aim to identify and understand the complexities of intervention if they are to be used for future intervention development or the strategies needed to implement the same intervention in a different setting. Complex interventions are public health interventions that are not drugs or surgical procedures but have many potential active aspects of intervention. In this paper, process evaluations are aligned with MRC guidelines to identify contextual factors related to outcomes to assess the quality of implementation. This paper briefly discusses the perceptions of research team on the implementation of the intervention of ‘Engaging Adolescents in Changing Behaviour’ (EACH-B), a school-based complex intervention study aiming to improve diet and physical activity among adolescents aged 12-13 years. Through qualitative interviews and focus groups with 10 staff members, we aimed to understand their experiences and reflections on implementing the EACH-B trial delivered in 49 Schools around Hampshire, England. Data were uploaded into NVivo, and analysis was conducted using thematic analysis. The investigation revealed two overarching themes: (a) how the communication patterns with teachers were impacted during the delivery of implementation and (b) what were the team’s strategies to keep logistics aligned with the research process that impacted the overall implementation of the trial. The paper informs adaptation strategies used by the research team to establish and maintain effective communication with the teachers as well as the thoughtfulness of the team’s logistic strategy for the successful delivery of the trial.

Keywords: complex interventions, process evaluation, adaptation strategies, randomised controlled trial

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Authors: Modi Alsubaie, Chris Dickens, Barnaby Dunn, Andy Gibson, Obioha Ukoumunned, Alison Evans, Rachael Vicary, Manish Gandhi, Willem Kuyken

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Background: Depression co-occurs in 20% of people with cardiovascular disorders, can persist for years and predicts worse physical health outcomes. While psychosocial treatments have been shown to effectively treat acute depression in those with comorbid cardiovascular disorders, to date there has been no evaluation of approaches aiming to prevent relapse and treat residual depression symptoms in this group. Therefore, the current study aimed to examine the feasibility and acceptability of a randomised controlled trial design evaluating an adapted version of mindfulness-based cognitive therapy (MBCT) designed specifically for people with co-morbid depression and cardiovascular disorders. Methods: A 3-arm feasibility randomised controlled trial was conducted, comparing MBCT adapted for people with cardiovascular disorders plus treatment as usual (TAU), mindfulness-based stress reduction (MBSR) plus TAU, and TAU alone. Participants completed a set of self-report measures of depression severity, anxiety, quality of life, illness perceptions, mindfulness, self-compassion and affect and had their blood pressure taken immediately before, immediately after, and three months following the intervention. Those in the adapted-MBCT arm additionally underwent a qualitative interview to gather their views about the adapted intervention. Results: 3400 potentially eligible participants were approached when attending an outpatient appointment at a cardiology clinic or via a GP letter following a case note search. 242 (7.1%) were interested in taking part, 59 (1.7%) were screened as being suitable, and 33 (<1%) were eventually randomised to the three groups. The sample was heterogeneous in terms of whether they reported current depression or had a history of depression and the time since the onset of cardiovascular disease (one to 25 years). Of 11 participants randomised to adapted MBCT seven completed the full course, levels of home mindfulness practice were high, and positive qualitative feedback about the intervention was given. Twenty-nine out of 33 participants randomised completed all the assessment measures at all three-time points. With regards to the primary outcome (depression), five out of the seven people who completed the adapted MBCT and three out of five under MBSR showed significant clinical change, while in TAU no one showed any clinical change at the three-month follow-up. Conclusions: The adapted MBCT intervention was feasible and acceptable to participants. However, aspects of the trial design were not feasible. In particular, low recruitment rates were achieved, and there was a high withdrawal rate between screening and randomisation. Moreover, the heterogeneity in the sample was high meaning the adapted intervention was unlikely to be well tailored to all participants needs. This suggests that if the decision is made to move to a definitive trial, study recruitment procedures will need to be revised to more successfully recruit a target sample that optimally matches the adapted intervention.

Keywords: mindfulness-based cognitive therapy (MBCT), depression, cardiovascular disorders, feasibility, acceptability

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Authors: Emmanuel A. David, Rebecca O. Soremekun, Roseline I. Aderemi-Williams

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Background: The complexities involved in the management of diabetes mellitus require a multi-dimensional, multi-professional collaborative and continuous care by health care providers and a substantial self-care by the patients in order to achieve desired treatment outcomes. The effect of pharmacists’ care in the management of diabetes in resource-endowed nations is well documented in literature, but randomised-controlled assessment of the impact of pharmacist-led care among patients with diabetes in resource-limited settings like Nigeria and sub-Saharan Africa countries is scarce. Objective: To evaluate the impact of Pharmacist-led care on glycaemic control in patients with uncontrolled type 2 diabetes, using a randomised-controlled study design Methods: This study employed a prospective randomised controlled design, to assess the impact of pharmacist-led care on glycaemic control of 108 poorly controlled type 2 diabetic patients. A total of 200 clinically diagnosed type 2 diabetes patients were purposively selected using fasting blood glucose ≥ 7mmol/L and tested for long term glucose control using Glycated haemoglobin measure. One hundred and eight (108) patients with ≥ 7% Glycated haemoglobin were recruited for the study and assigned unique identification numbers. They were further randomly allocated to intervention and usual care groups using computer generated random numbers, with each group containing 54 subjects. Patients in the intervention group received pharmacist-structured intervention, including education, periodic phone calls, adherence counselling, referral and 6 months follow-up, while patients in usual care group only kept clinic appointments with their physicians. Data collected at baseline and six months included socio-demographic characteristics, fasting blood glucose, Glycated haemoglobin, blood pressure, lipid profile. With an intention to treat analysis, Mann-Whitney U test was used to compared median change from baseline in the primary outcome (Glycated haemoglobin) and secondary outcomes measure, effect size was computed and proportion of patients that reached target laboratory parameter were compared in both arms. Results: All enrolled participants (108) completed the study, 54 in each study. Mean age was 51±11.75 and majority were female (68.5%). Intervention patients had significant reduction in Glycated haemoglobin (-0.75%; P<0.001; η2 = 0.144), with greater proportion attaining target laboratory parameter after 6 months of care compared to usual care group (Glycated haemoglobin: 42.6% vs 20.8%; P=0.02). Furthermore, patients who received pharmacist-led care were about 3 times more likely to have better glucose control (AOR 2.718, 95%CI: 1.143-6.461) compared to usual care group. Conclusion: Pharmacist-led care significantly improved glucose control in patients with uncontrolled type 2 diabetes mellitus and should be integrated in the routine management of diabetes patients, especially in resource-limited settings.

Keywords: glycaemic control , pharmacist-led care, randomised-controlled trial , type 2 diabetes mellitus

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Authors: Keith T. S. Tung, Frederick K. Ho, Rosa S. Wong, Camilla K. M. Lo, Wilfred H. S. Wong, C. B. Chow, Patrick Ip

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Objectives: Underage drinking is an important public health problem both locally and globally. Conventional prevention/intervention relies on unidirectional knowledge transfer such as mail leaflets or health talks which showed mixed results in changing the target behaviour. Previously, we conducted a school internet-based intervention which was found to be effective in reducing alcohol use among adolescents, yet the underlying mechanisms have not been properly investigated. This study, therefore, examined the mechanisms that explain how the intervention produced a change in alcohol drinking behaviours among Chinese adolescent as observed in our previous clustered randomised controlled trial (RCT) study. Methods: This is a cluster randomised controlled trial with parallel group design. Participating schools were randomised to the Internet intervention or the conventional health education group (control) with a 1:1 allocation ratio. Secondary 1–3 students of the participating schools were enrolled in this study. The Internet intervention was a web-based quiz game competition, in which participating students would answer 1,000 alcohol-related multiple-choice quiz questions. Conventional health education group received a promotional package on equivalent alcohol-related knowledge. The participants’ alcohol-related attitude, knowledge, and perceived behavioural control were self-reported before the intervention (baseline) and one month and three months after the intervention. Results: Our RCT results showed that participants in the Internet group were less likely to drink (risk ratio [RR] 0.79, p < 0.01) as well as in lesser amount (β -0.06, p < 0.05) compared to those in the control group at both post-intervention follow-ups. Within the intervention group, regression analyses showed that high quiz scorer had greater improvement in alcohol-related knowledge (β 0.28, p < 0.01) and attitude (β -0.26, p < 0.01) at 1 month after intervention, which in turn increased their perceived behavioural control against alcohol use (β 0.10 and -0.26, both p < 0.01). Attitude, compared to knowledge, was found to be a stronger contributor to the intervention effect on perceived behavioural control. Conclusions: Our internet-based intervention has demonstrated effectiveness in reducing the risk of underage drinking when compared with conventional health education. Our study results further showed an attitude to be a more important factor than knowledge in changing health-related behaviour. This has an important implication for future prevention/intervention on an underage drinking problem.

Keywords: adolescents, internet-based intervention, randomized controlled trial, underage drinking

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Authors: Mark Linden, Rachel Leonard, Trisha Forbes, Michael Brown, Lynne Marsh, Stuart Todd, Nathan Hughes, Maria Truesdale

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Background: Current interventions which aim to improve the mental health of family carers are often face to face, which can create barriers to full participation. Online interventions can offer flexibility in delivery compared to face to face approaches. The primary objective of this study is to determine the feasibility of delivering the Carers-ID online intervention, while the secondary outcome is to improve the mental health of family carers of people with intellectual disabilities. Methods: Family carers (n = 120) will be randomised to receive the intervention (n=60) or assigned to a wait-list control (n=60) group. The intervention (www.Carers-ID.com) consists of fourteen modules which cover topics including promoting resilience, providing peer support, reducing anxiety, managing stress, accessing local supports, managing family conflict and information for siblings who are carers. Primary outcomes for this study include acceptability and feasibility of the outcome measures, recruitment, participation and retention rates and effect sizes. Secondary outcomes will be completed at three time points (baseline, following intervention completion and three months after completion). Secondary outcomes include, depression, anxiety, stress, well-being , resilience and social connectedness. Participants (n=12) who have taken part in the intervention arm of the research will be invited to participate in semi-structured interviews as part of the process evaluation. Discussion: To determine whether a full-scale randomised controlled effectiveness trial is warranted, feasibility testing of the intervention and trial procedures is a necessary first step. The Carers-ID intervention provides an accessible resource for family carers to support their mental health and well-being.

Keywords: intellectual disability, family carer, feasibility trial, online intervention

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Authors: Elaine Yee Sing Wong, Jonine Jancey, Andy H. Lee, Anthony P. James

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Singapore has a rapidly aging population, where the majority of older women aged 50 years and above, are physically inactive and have unhealthy dietary habits, placing them at ‘high risk’ of non-communicable diseases. Given the multiplicity of less than optimal dietary habits and high levels of physical inactivity among Singaporean women, it is imperative to develop appropriate lifestyle interventions at recreational centres to enhance both their physical and nutritional knowledge, as well as provide them with the opportunity to develop skills to support behaviour change. To the best of our knowledge, this proposed study is the first physical activity and nutrition cluster randomised controlled trial conducted in Singapore for older women. Findings from this study may provide insights and recommendations for policy makers and key stakeholders to create new healthy living, recreational centres with supportive environments. This 6-month community-based cluster randomised controlled trial will involve the implementation and evaluation of physical activity and nutrition program for community dwelling Singaporean women, who currently attend recreational centres to promote social leisure activities in their local neighbourhood. The intervention will include dietary education and counselling sessions, physical activity classes, and telephone contact by certified fitness instructors and qualified nutritionists. Social Cognitive Theory with Motivational Interviewing will inform the development of strategies to support health behaviour change. Sixty recreational centres located in Singapore will be randomly selected from five major geographical districts and randomly allocated to the intervention (n=30) or control (n=30) cluster. A sample of 600 (intervention n=300; control n=300) women aged 50 years and above will then be recruited from these recreational centres. The control clusters will only undergo pre and post data collection and will not receive the intervention. It is hypothesised that by the end of the intervention, the intervention group participants (n = 300) compared to the control group (n = 300), will show significant improvements in the following variables: lipid profile, body mass index, physical activity and dietary behaviour, anthropometry, mental and physical health. Data collection will be examined and compared via the Statistical Package for the Social Science version 23. Descriptive and summary statistics will be used to quantify participants’ characteristics and outcome variables. Multi-variable mixed regression analyses will be used to confirm the effects of the proposed health intervention, taking into account the repeated measures and the clustering of the observations. The research protocol was approved by the Curtin University Human Research Ethics Committee (approval number: HRE2016-0366). The study has been registered with the Australian and New Zealand Clinical Trial Registry (12617001022358).

Keywords: community based, healthy aging, intervention, nutrition, older women, physical activity

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Authors: B. W. Kenny, D.Mansour, K. G. Mansour, J. Attia, B. Meads

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There is currently insufficient evidence to make a conclusive statement about safety while immobilized in a short arm cast. There is a paucity of published literature on this topic. The purpose of this study is to specifically evaluate short arm casts and their effect on driving abilities, particularly steering and avoidance of obstacles. The ability to drive safely is extrapolated from this data. In this study, a randomised, controlled, crossover design was used to assess 30 subjects randomised into 2 groups. A Logitech force feedback steering column and simulated driving program with a standardised road course was used. Objective outcome measures were the number of times subjects drove off the track, the number of crashes, time to lap completion and subjective assessment on whether wearing a short arm plaster cast impeded their steering. Recruited subjects had no upper limb pathology. The side of the applied plaster cast was randomised. The mean lap completion time reduced with repetition, the difference being statistically significant. There was no significant difference in mean number of times subjects in casts drove off the track (3 with vs. 3.07 without casts), average number of crashes (1.27 vs 0.97). Steering ability was not reduced whilst a subject was immobilised in a short arm Plaster of Paris cast, despite subject’s own impressions that their steering was impeded. This may help guide doctors in their advice to patients regarding driving in these casts.

Keywords: upper limb, arm injury, plaster cast, splint, driving, automobile, bone fracture

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Authors: Wenru Wang

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Over the past decades, Asia has emerged as the ‘diabetes epicentre’ in the world due to rapid economic development, urbanization and nutrition transition. There is an urgent need to develop more effective and cost-effective care management strategies in response to this rising diabetes epidemic. This study aims to develop and compare a nurse-led smartphone-based self-management programme with an existing nurse-led diabetes service on health-related outcomes among type 2 diabetes patients with poor glycemic control in Singapore. We proposed a randomized controlled trial with pre- and repeated post-tests control group design. A total of 128 type 2 diabetes patients with poor glycemic control will be recruited from the diabetes clinic of an acute public hospital in Singapore through convenience sampling. Study participants will be either randomly allocated to the experimental group or control group. Outcome measures used will include the 10-item General Self-Efficacy Scale, 11-item Revised Summary of Diabetes Self-care Activities, and 19-item Diabetes-Dependent Quality of Life. Data will be collected at 3-time points: baseline, three months and six months from the baseline, respectively. It is expected that this programme will be an alternative offered to diabetes patients to master their self-care management skills, in addition to the existing diabetes service provided in diabetes clinics in Singapore hospitals. Also, the self-supporting and less resource-intensive nature of this programme, through the use of smartphone app as a mode of intervention delivery, will greatly reduce nurses’ direct contact time with patients and allow more time to be allocated to those who require more attention. The study has been registered with clinicaltrials.gov. The trial registration number is NCT03088475.

Keywords: type 2 diabetes, poor glycaemic control, nurse-led, smartphone-based, self-management, health-relevant outcomes

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Authors: Anna Rinaldi, Pierfrancesco Dellino

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COVID-19 vaccine hesitancy can be observed at different rates in different countries. In June 2021, 1,068 people were surveyed in France and Italy to inquire about individual potential acceptance, focusing on time preferences in a risk-return framework: having the vaccination today, in a month, and in 3 months; perceived risks of vaccination and COVID-19; and expected benefit of the vaccine. A randomized controlled trial was conducted to understand how everyday stimuli like fact-based news about vaccines impact an audience's acceptance of vaccination. The main experiment involved two groups of participants and two different articles about vaccine-related thrombosis taken from two Italian newspapers. One article used a more abstract description and language, and the other used a more anecdotal description and concrete language; each group read only one of these articles. Two other groups were assigned categorization tasks; one was asked to complete a concrete categorization task, and the other an abstract categorization task. Individual preferences for vaccination were found to be variable and unstable over time, and individual choices of accepting, refusing, or delaying could be affected by the way news is written. In order to understand these dynamic preferences, the present work proposes a new model based on seven categories of human behaviors that were validated by a neural network. A treatment effect was observed: participants who read the articles shifted to vaccine hesitancy categories more than participants assigned to other treatments and control. Furthermore, there was a significant gender effect, showing that the type of language leading to a lower hesitancy rate for men is correlated with a higher hesitancy rate for women and vice versa. This outcome should be taken into consideration for an appropriate gender-based communication campaign aimed at achieving herd immunity. The trial was registered at ClinicalTrials.gov NCT05582564 (17/10/2022).

Keywords: vaccine hesitancy, risk elicitation, neural network, covid19

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Authors: Derwin K. C. Chan, Alfred S. Y. Lee

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The integrated model of self-determination theory and the theory of planned behaviour has been successfully applied to explain individuals’ adherence to health behaviours, including behavioural adherence toward rehabilitation. This study was a randomised controlled trial that examined the effectiveness of an mHealth intervention (i.e., mobile application) developed based on this integrated model in promoting treatment adherence of patients of anterior cruciate ligament rupture during their post-surgery home-based rehabilitation period. Subjects were 67 outpatients (aged between 18 and 60) who undertook anterior cruciate ligament (ACL) reconstruction surgery for less than 2 months for this study. Participants were randomly assigned either into the treatment group (who received the smartphone application; N = 32) and control group (who receive standard treatment only; N = 35), and completed psychological measures relating to the theories (e.g., motivations, social cognitive factors, and behavioural adherence) and clinical outcome measures (e.g., subjective knee function (IKDC), laxity (KT-1000), muscle strength (Biodex)) relating to ACL recovery at baseline, 2-month, and 4-month. Generalise estimating equation showed the interaction between group and time was significant on intention was only significant for intention (Wald x² = 5.23, p = .02), that of perceived behavioural control (Wald x² = 3.19, p = .07), behavioural adherence (Wald x² = 3.08, p = .08, and subjective knee evaluation (Wald x² = 2.97, p = .09) were marginally significant. Post-hoc between-subject analysis showed that control group had significant drop of perceived behavioural control (p < .01), subjective norm (p < .01) and intention (p < .01), behavioural adherence (p < .01) from baseline to 4-month, but such pattern was not observed in the treatment group. The treatment group had a significant decrease of behavioural adherence (p < .05) in the 2-month, but such a decrease was not observed in 4-month (p > .05). Although the subjective knee evaluation in both group significantly improved at 2-month and 4-month from the baseline (p < .05), and the improvements in the control group (mean improvement at 4-month = 40.18) were slightly stronger than the treatment group (mean improvement at 4-month = 34.52). In conclusion, the findings showed that the theory driven mobile application ameliorated the decline of treatment intention of home-based rehabilitation. Patients in the treatment group also reported better muscle strength than control group at 4-month follow-up. Overall, the mobile application has shown promises on tackling the problem of orthopaedics outpatients’ non-adherence to medical treatment.

Keywords: self-determination theory, theory of planned behaviour, mobile health, orthopaedic patients

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Authors: Jeffey George, Varghese Thomas

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Background and Objectives: PHG is an important source of gastrointestinal bleeding in patients with portal hypertension. Aim: To assess the progression to severe portal hypertensive gastropathy(PHG) in patients with cirrhosis who were treated with maximum tolerated dose of propranalol, after variceal eradication to grade II or below. Methods: Cirrhotic patients(child A and B) presenting with upper gastrointestinal bleeding with endoscopic findings of mild or no PHG were followed up over 6 months after variceal eradication to assess the progression to severe PHG. Included patients were randomised to either maximum tolerated doses of propranalol (group A) or to no treatment (group B). Primary end point of the study were the development of gastrointestinal bleed, evidence of hepatic decompensation and death. Progression to severe PHG were compared between the two groups. Results: 56 patients (49 males) were enrolled (group A = 28, group B = 28). 8 patients were excluded from final analysis (gi bleed=5, encephalopathy=2,HCC=1 including 4 deaths).3 patients were lost to follow-up, and 1 developed intolerance to propranalol. Mean dose of propranalol used was 60 mg per day. Progression to severe PHG in the fundus over 6 months was 23.8% in group A versus 15.8 % in group B (p = 0.52). Severe PHG was noted in body in 14.3% in group A versus 21.1% in group B (p = 0.57). 23.8 % in group A had progression to severe PHG compared with 15.8 % in group B (p =0.52). There was no statistically significant difference in the progression of PHG between the two groups(p=0.43). Conclusion: In this short term study propranalol was found not to prevent the progression to severe portal hypertensive gastropathy in cirrhotic patients who had undergone endotherapy for esophageal varices.

Keywords: propranalol, portal hypertensive gastropathy, cirrhotic patients, gastroenterology

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Authors: Aisling Gough, Ruth F. Hunter, Jianjun Tang, Sarah F. Brennan, Oliver Smith, Mark A. Tully, Chris Patterson, Alberto Longo, George Hutchinson, Lindsay Prior, David French, Jean Adams, Emma McIntosh, Frank Kee

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Background: As a large proportion of the UK workforce is employed in sedentary occupations, worksite interventions have the potential to contribute significantly to the health of the population. The UK Government is currently encouraging the use of financial incentives to promote healthier lifestyles but there is a dearth of evidence regarding the effectiveness and sustainability of incentive schemes to promote physical activity in the workplace. Methods: A large cluster RCT is currently underway, incorporating nested behavioural economic field experiments and process evaluation, to evaluate the effectiveness of a Physical Activity Loyalty Scheme. Office-based employees were recruited from large public sector organisations in Lisburn and Belfast (Northern Ireland) and randomised to an Intervention or Control group. Participants in the Intervention Group were encouraged to take part in 150 minutes of physical activity per week through provision of financial incentives (retailer vouchers) to those who met physical activity targets throughout the course of the 6 month intervention. Minutes of physical activity were monitored when participants passed by sensors (holding a keyfob) placed along main walking routes, parks and public transport stops nearby their workplace. Participants in the Control Group will complete the same outcome assessments (waiting-list control). The primary outcome is steps per day measured via pedometers (7 days). Secondary outcomes include health and wellbeing (Short Form-8, EuroQol-5D-5L, Warwick Edinburgh Mental Well Being Scale), and work absenteeism and presenteeism. Data will be collected at baseline, 6, 12 and 18 months. Information on PAL card & website usage, voucher downloads and redemption of vouchers will also be collected as part of a comprehensive process evaluation. Results: In total, 853 participants have been recruited from 9 workplaces in Lisburn, 12 buildings within the Stormont Estate, Queen’s University Belfast and Belfast City Hospital. Participants have been randomised to intervention and control groups. Baseline and 6-month data for the Physical Activity Loyalty Scheme has been collected. Findings regarding the effectiveness of the intervention from the 6-month follow-up data will be presented. Discussion: This study will address the gap in knowledge regarding the effectiveness and cost-effectiveness of a workplace-based financial incentive scheme to promote a healthier lifestyle. As the UK workforce is increasingly sedentary, workplace-based physical activity interventions have significant potential in terms of encouraging employees to partake in physical activity during the working day which could lead to substantial improvements in physical activity levels overall. Implications: If a workplace based physical activity intervention such as this proves to be both effective and cost-effective, there is great potential to contribute significantly to the health and wellbeing of the workforce in the future. Workplace-based physical activity interventions have the potential to improve the physical and mental health of employees which may in turn lead to economic benefits for the employer, such as reduction in rates of absenteeism and increased productivity.

Keywords: behaviour change, cluster randomised controlled trial, loyalty scheme, physical activity

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Authors: Jennifer A. Barrowclough, Caroline A. Crowther, Bridget Kool

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Fetal malposition in labour is associated with adverse maternal and infant health outcomes. Evidence for effective interventions for fetal malposition is inconclusive. The feasibility and design of a randomized controlled trial (RCT) of maternal posture to improve maternal and infant outcomes of malposition should be considered, based on the hypothesis that gravity corrects malposition. The aim was to assess pregnant women’s views on the acceptability of a future trial of maternal posture for fetal malposition in labour, and the enablers and barriers of participation. Method: An online anonymous survey of pregnant women was conducted in Auckland during 2020. Descriptive summaries of quantitative data used chi-square to assess differences in proportions. The influence of maternal characteristics on women’s responses was assessed using cross-tabulation. Free text responses were analysed thematically. Results: Respondents (n=206) were mostly aged26-35 years (75%), of 29-38 weeks gestation (71%), of European (40%) or Asian (36%) ethnicity, were evenly nulliparous or multiparous. Most women (76%) had heard of fetal malposition in labour however only 28% were aware of the use of maternal posture to correct this. Most women (86%) were interested in labour research. Although 37% indicated they would participate in a future RCT of posture for fetal malposition, nearly half (47%) were unsure and a further quarter (15%) indicated they would not participate. Comfort was the predominant concern (22%). Almost half of the respondents (49%) indicated they would consult their partner before deciding on participation in an RCT. Conclusions: Participation in a trial of maternal posture in labour can be enabled through measures to enhance maternal comfort, increased awareness of malposition and the role of posture, and the involvement of partners during trial counselling and recruitment.

Keywords: pregnant women, labour, presentation, posture, randomized controlled trial, survey

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Authors: Antonio Lopez-Villegas, Rafael Bautista-Mesa, Emilio Robles-Musso, Daniel Catalan-Matamoros, Cesar Leal-Costa

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Objectives: The purpose of this trial was to evaluate the burden borne by and the costs to informal caregivers of users with telemonitoring of pacemakers. Methods: This is a controlled, non-randomised clinical trial, with data collected from informal caregivers, five years after implantation of pacemakers. The Spanish version of the Survey on Disabilities, Personal Autonomy, and Dependency Situations was used to get information on clinical and social characteristics, levels of professionalism, duration and types of care, difficulties in providing care, health status, economic and job aspects, impact on the family or leisure due to informal caregiving for patients with pacemakers. Results: After five years of follow-up, 55 users with pacemakers finished the study. Of which, 50 were helped by a caregiver, 18 were included in the telemonitoring group (TM) and 32 in the conventional follow-up group (HM). Overall, females represented 96.0% of the informal caregivers (88.89% in TM and 100.0% in HM group). The mean ages were 63.17 ± 15.92 and 63.13 ± 14.56 years, respectively (p = 0.83) in the groups. The majority (88.0%) of the caregivers declared that they had to provide their services between 6 and 7 days per week (83.33% in TM group versus 90.63% in HM group), without significant differences between both groups. The costs related to care provided by the informal caregivers were 47.04% higher in the conventional follow-up group than in the TM group. Conclusions: The results of this trial confirm that there were no significant differences between the informal caregivers regarding to baseline characteristics, workload and time worked in both groups of follow-up. The costs incurred by the informal caregivers providing care for users with pacemakers included in telemonitoring group are significantly lower than those in the conventional follow-up group. Trial registration: ClinicalTrials.gov NCT02234245. Funding: The PONIENTE study, has been funded by the General Secretariat for Research, Development and Innovation, Regional Government of Andalusia (Spain), project reference number PI/0256/2017, under the research call 'Development and Innovation Projects in the Field of Biomedicine and Health Sciences', 2017.

Keywords: costs, disease burden, informal caregiving, pacemaker follow-up, remote monitoring, telemedicine

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Authors: Nicole Selvi Hill, Archchana Radhakrishnan

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Introduction: Traumatic brain injury (TBI) is a leading cause of mortality among trauma patients. In the management of TBI, the main principle is avoiding cerebral ischemia, as this is a strong determiner of neurological outcomes. The use of vasoactive drugs, such as vasopressin, has an important role in maintaining cerebral perfusion pressure to prevent secondary brain injury. Current guidelines do not suggest a preferred vasoactive drug to administer in the management of TBI, and there is a paucity of information on the therapeutic potential of vasopressin following TBI. Vasopressin is also an endogenous anti-diuretic hormone (AVP), and pathways mediated by AVP play a large role in the underlying pathological processes of TBI. This creates an overlap of discussion regarding the therapeutic potential of vasopressin following TBI. Currently, its popularity lies in vasodilatory and cardiogenic shock in the intensive care setting, with increasing support for its use in haemorrhagic and septic shock. Methodology: This is a review article based on a literature review. An electronic search was conducted via PubMed, Cochrane, EMBASE, and Google Scholar. The aim was to identify clinical studies looking at the therapeutic administration of vasopressin in severe traumatic brain injury. The primary aim was to look at the neurological outcome of patients. The secondary aim was to look at surrogate markers of cerebral perfusion measurements, such as cerebral perfusion pressure, cerebral oxygenation, and cerebral blood flow. Results: Eight papers were included in the final number. Three were animal studies; five were human studies, comprised of three case reports, one retrospective review of data, and one randomised control trial. All animal studies demonstrated the benefits of vasopressors in TBI management. One animal study showed the superiority of vasopressin in reducing intracranial pressure and increasing cerebral oxygenation over a catecholaminergic vasopressor, phenylephrine. All three human case reports were supportive of vasopressin as a rescue therapy in catecholaminergic-resistant hypotension. The retrospective review found vasopressin did not increase cerebral oedema in TBI patients compared to catecholaminergic vasopressors; and demonstrated a significant reduction in the requirements of hyperosmolar therapy in patients that received vasopressin. The randomised control trial results showed no significant differences in primary and secondary outcomes between TBI patients receiving vasopressin versus those receiving catecholaminergic vasopressors. Apart from the randomised control trial, the studies included are of low-level evidence. Conclusion: Studies favour vasopressin within certain parameters of cerebral function compared to control groups. However, the neurological outcomes of patient groups are not known, and animal study results are difficult to extrapolate to humans. It cannot be said with certainty whether vasopressin’s benefits stand above usage of other vasoactive drugs due to the weaknesses of the evidence. Further randomised control trials, which are larger, standardised, and rigorous, are required to improve knowledge in this field.

Keywords: catecholamines, cerebral perfusion pressure, traumatic brain injury, vasopressin, vasopressors

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Authors: Jamunarani Appalasamy, Tha Kyi Kyi, Quek Kia Fatt, Joyce Pauline Joseph, Anuar Zaini M. Zain

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Background: The Health Belief Theory had always been associated with chronic disease management. Various health behaviour concepts and perception branching from this Health Belief Theory had involved with medication understanding, use, and self-efficacy which directly link to medication adherence. In a previous quantitative and qualitative study, stroke patients in Malaysia were found to be strongly believing information obtained by various sources such as the internet and social communication. This action leads to lower perception of their stroke preventative medication benefit which in long-term creates non-adherence. Hence, this study intends to pilot an intervention which uses audio-visual concept incorporated with mHealth service to enhance learning and self-reflection among stroke patients to manage their disease. Methods/Design: Twenty patients will be allocated to a proposed intervention whereas another twenty patients are allocated to the usual treatment. The intervention involves a series of developed audio-visual videos sent via mobile phone which later await for responses and feedback from the receiver (patient) via SMS or recorded calls. The primary outcome would be the medication understanding, use and self-efficacy measured over two months pre and post intervention. Secondary outcome is measured from changes of blood parameters and other self-reported questionnaires. Discussion: This study shall also assess uptake/attrition, feasibility, and acceptability of this intervention. Trial Registration: NMRR-15-851-24737 (IIR)

Keywords: health belief, medication understanding, medication use, self-efficacy

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Authors: Sharon Millen, Sarah Miller, Laura Dunne, Clare McGeady, Laura Neeson

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This paper presents the findings from a randomised controlled trial (RCT) and process evaluation of the Lifestart parenting programme. Lifestart is a structured child-centred programme of information and practical activity for parents of children aged from birth to five years of age. It is delivered to parents in their own homes by trained, paid family visitors and it is offered to parents regardless of their social, economic or other circumstances. The RCT evaluated the effectiveness of the programme and the process evaluation documented programme delivery and included a qualitative exploration of parent and child outcomes. 424 parents and children participated in the RCT: 216 in the intervention group and 208 in the control group across the island of Ireland. Parent outcomes included: parental knowledge of child development, parental efficacy, stress, social support, parenting skills and embeddedness in the community. Child outcomes included cognitive, language and motor development and social-emotional and behavioural development. Both groups were tested at baseline (when children were less than 1 year old), mid-point (aged 3) and at post-test (aged 5). Data were collected during a home visit, which took two hours. The process evaluation consisted of interviews with parents (n=16 at baseline and end-point), and focus groups with Lifestart Coordinators (n=9) and Family Visitors (n=24). Quantitative findings from the RCT indicated that, compared to the control group, parents who received the Lifestart programme reported reduced parenting-related stress, increased knowledge of their child’s development, and improved confidence in their parenting role. These changes were statistically significant and consistent with the hypothesised pathway of change depicted in the logic model. There was no evidence of any change in parents’ embeddedness in the community. Although four of the five child outcomes showed small positive change for children who took part in the programme, these were not statistically significant and there is no evidence that the programme improves child cognitive and non-cognitive skills by immediate post-test. The qualitative process evaluation highlighted important challenges related to conducting trials of this magnitude and design in the general population. Parents reported that a key incentive to take part in study was receiving feedback from the developmental assessment, which formed part of the data collection. This highlights the potential importance of appropriate incentives in relation to recruitment and retention of participants. The interviews with intervention parents indicated that one of the first changes they experienced as a result of the Lifestart programme was increased knowledge and confidence in their parenting ability. The outcomes and pathways perceived by parents and described in the interviews are also consistent with the findings of the RCT and the theory of change underpinning the programme. This hypothesises that improvement in parental outcomes, arising as a consequence of the programme, mediate the change in child outcomes. Parents receiving the Lifestart programme reported great satisfaction with and commitment to the programme, with the role of the Family Visitor being identified as one of the key components of the programme.

Keywords: parent-child relationship, parental self-efficacy, parental stress, school readiness

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Authors: Mohammad Javad Zehtab, S. Alireza Mirghasemi, Ali Majlesara, Parvin Tajik, Babak Siavashi

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Objective: There are different modalities proposed for tennis elbow treatment with few randomized trials comparing them. We designed a study to compare the effectiveness of five different modalities and determine the usefulness of recently proposed extensor grip test (EGT) in predicting the response to treatment. Methods: In a randomized controlled clinical trial 92 of 98 tennis elbow patients in Sina hospital of Tehran, Iran between 2006 and 2007 fulfill trial entry criteria, among these patients 56 (60.9%) had positive EGT result. Stratified on EGT result, patients allocated randomly to 5 treatment groups: Brace (B) group, physiotherapy (P), brace + physiotherapy (BP), injection (I) and injection + physiotherapy (IP). Results: Patients who had positive result of EGT had better response to treatments: less SOC (p = 0.06), less PFFQ and patients’ satisfaction scores (p < 0.001). Among the treatment IP was the most successful, then BP, P and B, respectively; injection was the worst treatment modality. Response to treatment was comparable in all groups between EGT positive and negative patients except bracing; in which positive EGT was correlated with a dramatic response to treatment. Conclusion: In all patients IP and then BP is recommended but in EGT negatives, bracing seems to be of no use. Injection alone is not recommended in either group.

Keywords: tennis elbow, extensor grip test, physiotherapy, tennis elbow treatment

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Authors: Sayeeda Laeque Bangi

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Objectives: Treating white spot lesions (WSL) to create a sound and esthetically pleasing enamel surface is a question yet to be fully answered. The objective of this randomized controlled trial was to measure and compare the degree of regression of WSL during orthodontic treatment achieved by using three commercially available materials. Methods: A single-blinded randomized prospective clinical trial, comprising 80 patients categorized into four groups (one control group and three experimental groups, with 20 subjects per group) using block randomization, was conducted. Group A (control group): Colgate strong toothpaste; and experiments groups were Group B: GC tooth mousse, Group C: Phos-Flur mouthwash and Group D: SHY-NM. Subjects were instructed to use the designated dentifrice/mouthwash and photographs were taken at baseline, third and sixth months, and white spot lesions were reassessed in the maxillomandibular anterior teeth. Results: All the three groups had shown an improvement in WSL. But Group B has shown the greatest difference in mean values of decalcification index (DI) scores. Conclusion: All three commercially available products showed a regression of WSL over a 6-month duration. GC tooth mousse proved to be the most effective means of treating WSL over other regimens.

Keywords: white spot lesions, dentifrices, orthodontic therapy, remineralization

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Authors: Teris Cheung, Joyce Yuen Ting Lam, Kwan Hin Fong, Calvin Pak-Wing Cheng, Julie Sittlington, Yu-Tao Xiang, Tim Man Ho Li

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Insomnia is one of the most common health problems in the general population. Insomnia can be acute, intermittent, and become chronic, often due to comorbidity with other physical and mental health conditions. Although there are conventional pharmaceutical and psychotherapeutic treatments to treat symptoms of insomnia, however; there is no robust and novel randomized controlled trial (RCT) using transdermal neurostimulation on individuals with insomnia symptoms. This gives us the impetus to execute the first nationwide RCT. Aim: To evaluate the efficacy of Electrical Vestibular Stimulation (VeNS) on individuals with insomnia in Hong Kong. Design: This study was a two-armed, double blinded, randomized, sham-controlled trial. Sampling: 60 community-dwelling adults aged 18 and 60 years with moderate insomnia symptoms or above (Insomnia Severity Index > 14) were recruited. All subjects were computerized randomized into either the active VeNS group or the sham VeNS group on a 1:1 ratio. Intervention: All participants received a home-use VeNS device and used 30-min VeNS sessions during five consecutive days across a 4-week period (total treatment hours: 10). Baseline measurements and post-VeNS evaluation of the psychological outcomes, including 1) insomnia severity, 2) sleep quality, and 3) quality of life were investigated. The short-and long-term sustainability of the VeNS intervention was assessed immediately after poststim and at a 1-month and 3-month follow-up period. Data analysis: A mixed GEE model was used to analyze the repeated measures data. Missing data were managed by multiple imputations. The level of significance was set to p < 0.05. Significance of the study: This is the first trial to examine the efficacy and safety of VeNS among adults with insomnia symptoms in Hong Kong. Findings that emerged were used to determine whether this VeNS device can be considered a self-help technological device to reduce the severity of insomnia in the community setting and to reduce the global disease burden. Clinical Trial Registration: ClinicalTrials.gov, identifier: NCT04452981.

Keywords: adults, insomnia, neuromodulation, rct, vestibular stimulation

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Authors: Bara M Yousef, Naresh B Raj, Nadiah W Arfah, Brightlin N Dhas

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Background: Executive function (EF) impairment is common in children with autism spectrum disorder (ASD). EF strategies are considered effective in improving the therapeutic outcomes of children with ASD. Aims: This study primarily aims to explore whether integrating EF strategies combined with regular occupational therapy intervention is more effective in improving daily life skills (DLS) and sensory integration/processing (SI/SP) skills than regular occupational therapy alone in children with ASD and secondarily aims to assess treatment outcomes on improving visual motor integration (VMI) skills. Procedures: A total of 92 children with ASD will be recruited and, following baseline assessments, randomly assigned to the treatment group (45-min once weekly individual occupational therapy plus EF strategies) and control group (45-min once weekly individual therapy sessions alone). Results and Outcomes: All children will be evaluated systematically by assessing SI/SP, DLS, and VMI, skills at baseline, 7 weeks, and 14 weeks of treatment. Data will be analyzed using ANCOVA and T-test. Conclusions and Implications: This single-blind, randomized controlled trial will provide empirical evidence for the effectiveness of EF strategies when combined with regular occupational therapy programs. Based on trial results, EF strategies could be recommended in multidisciplinary programs for children with ASD. Trial Registration: The trial has been registered in the clinicaltrail.gov for a registry, protocol ID: MRC-01-22-509 ClinicalTrials.gov Identifier: NCT05829577, registered 25th April 2023

Keywords: autism spectrum disorder, executive function strategies, daily life skills, sensory integration/processing, visual motor integration, occupational therapy, effectiveness

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Authors: Hannah M. Russell

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‘The Attach Project’ (TAP), is an educational intervention aimed at improving educational and socio-emotional outcomes for children who are looked after. TAP is underpinned by Attachment Theory and is adapted from Dyadic Developmental Psychotherapy (DDP), which is a treatment for children and young people impacted by complex trauma and disorders of attachment. TAP has been implemented in primary schools in Northern Ireland throughout the 2018/19 academic year. During this time, a design and implementation study has been conducted to assess the promise of effectiveness for the future dissemination and ‘scaling-up’ of the programme for a larger, randomised control trial. TAP has been designed specifically for implementation in a school setting and is comprised of a whole school element and a more individualised Key Adult-Key Child pairing. This design and implementation study utilises a mixed-methods research design consisting of quantitative, qualitative, and observational measures with stakeholder input and involvement being considered an integral component. The use of quantitative measures, such as self-report questionnaires prior to and eight months following the implementation of TAP, enabled the analysis of the strengths and direction of relations between the various components of the programme, as well as the influence of implementation factors. The use of qualitative measures, incorporating semi-structured interviews and focus groups, enabled the assessment of implementation factors, identification of implementation barriers, and potential methods of addressing these issues. Observational measures facilitated the continual development and improvement of ‘TAP training’ for school staff. Preliminary findings have provided evidence of promise for the effectiveness of TAP and indicate the potential benefits of introducing this type of attachment-based intervention across other educational settings. This type of intervention could benefit not only children who are looked after but all children who may be impacted by complex trauma or disorders of attachment. Furthermore, findings from this study demonstrate that it is possible for children to form a secondary attachment relationship with a significant adult in school. However, various implementation factors which should be addressed were identified throughout the study, such as the necessity of protected time being introduced to facilitate the development of a positive Key Adult- Key Child relationship. Furthermore, additional ‘re-cap’ training is required in future dissemination of the programme, to maximise ‘attachment friendly practice’ in the whole staff team. Qualitative findings have also indicated that there is a general opinion across school staff that this type of Key Adult- Key Child pairing could be more effective if it was introduced as soon as children begin primary school. This research has provided ample evidence for the need to introduce relationally based interventions in schools, to help to ensure that children who are looked after, or who are impacted by complex trauma or disorders of attachment, can thrive in the school environment. In addition, this research has facilitated the identification of important implementation factors and barriers to implementation, which can be addressed prior to the ‘scaling-up’ of TAP for a robust, randomised controlled trial.

Keywords: attachment, complex trauma, educational interventions, implementation

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Authors: Seyed Fakhreddin Hejazi, Leili Iranirad, Mohammad Sadeghi, Mohsen Talebizadeh

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Background: Contrast-induced nephropathy (CIN) remains to be a potentially serious complication of radiographic procedures. We performed this clinical trial to assess the preventive effect of allopurinol against CIN in high-risk patients undergoing coronary angiography. Methods: In this prospective randomized controlled trial, 140 patients with at least two risk factors for CIN undergoing coronary angiography were randomly assigned to either the allopurinol group or the control group. Patients in the allopurinol group received 300 mg allopurinol 24 hours before a procedure and intravenous hydration for 12 hours before and after coronary angiography, whereas patients in the control group received intravenous hydration. Serum creatinine (SCr), blood urea nitrogen (BUN) and uric acid were measured before contrast exposure and at 48 hours. CIN was defined as an increase of 25% in serum creatinine (SCr) or >0.5 mg/dl 48 hours after contrast administration. Results: CIN occurred in 11 out of 70 (7.9%) patients in the control group and in 8 out of 70 (5.7%) patients in the allopurinol group. There was no significant difference in the incidence of CIN between the two groups at 48 hours after administering the radiocontrast agent (p = 0.459). However, there were significant differences between the two groups in SCr, BUN, uric acid, and eGFR 48 hours after radiocontrast administration (p < 0.05). Conclusion: Our findings revealed that allopurinol had no substantial efficacy over hydration protocol in high-risk patients for the development of CIN.

Keywords: contrast-induced nephropathy, allopurinol, coronary angiography, contrast agent

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Authors: N. Dunleavy, E. Lovemore, K. Siljeur, D. Jackson, M. Hendricks, M. Hoosain, N. Plastow, S. Marais

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Background: The work requirements of sewing machine operators cause physical and emotional strain. Past ergonomic interventions have been provided to alleviate physical concerns; however, a holistic, multimodal intervention was needed to improve these factors. Aim: The study aimed to examine the effect of an occupational therapy programme on sewing machine operators’ pain, mental health, and productivity within a factory in the South African context. Methods: A pilot randomised control trial was conducted with 22 sewing machine operators within a single factory. Stratified randomisation was used to determine the experimental (EG) and control groups (CG), using measures for pain intensity, level of depression (mental health), and productivity rates as stratification variables. The EG received the multimodal intervention, incorporating education, seating adaptations, and mental health intervention. In three months, the CG will receive the same intervention. Pre- and post-intervention testing have occurred with upcoming three- and six-month follow-ups. Results: Immediate results indicate a statistically significant decrease in pain in both experimental and control groups; no change in productivity scores and depression between the two groups. This may be attributed to external factors. The values for depression further showed no statistical significance between the two groups and within pre-and post-test results. The Statistical Program for Social Sciences (SPSS) version-24 was used as the data analysis testing, where all the tests will be evaluated at a 5% significance level. Contribution of research: The research adds to the body of knowledge informing the Occupational Therapy role in work settings, providing evidence on the effectiveness of workplace-based multimodal interventions. Conclusion: The study provides initial data on the effectiveness of a pilot randomised control trial on pain and mental health in South Africa. Results indicated no quantitative change between the experimental and control groups; however, qualitative data suggest a clinical significance of the findings.

Keywords: ergonomics programme, occupational therapy, sewing machine operators, workplace-based multimodal interventions

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Authors: Kim H. K. Choy, Oliva H. K. Chu, W. Y. Keung, B. Lim, Winnie P. Y. Tang

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Background: The prevalence of workplace obesity is rising worldwide; therefore, the workplace is an ideal venue to implement weight control intervention. This pilot randomized controlled trial aimed to develop, implement, and evaluate a nutritional wellness program for obese health care providers working in a hospital. Methods: This hospital-based nutritional wellness program was an 8-week pilot randomized controlled trial for obese health care providers. The primary outcomes were body weight and body mass index (BMI). The secondary outcomes were serum fasting glucose, fasting cholesterol, triglyceride, high-density (HDL) and low-density (LDL) lipoprotein, body fat percentage, and body mass. Participants were randomly assigned to the intervention (n = 20) or control (n = 22) group. Participants in both groups received individual nutrition counselling and nutrition pamphlets, whereas only participants in the intervention group were given mobile phone text messages. Results: 42 participants completed the study. In comparison with the control group, the intervention group showed approximately 0.98 kg weight reduction after two months. Participants in intervention group also demonstrated clinically significant improvement in BMI, serum cholesterol level, and HDL level. There was no improvement of body fat percentage and body mass for both intervention and control groups. Conclusion: The nutritional wellness program for obese health care providers was feasible in hospital settings. Health care providers demonstrated short-term weight loss, decrease in serum fasting cholesterol level, and HDL level after completing the program.

Keywords: weight management, weight control, health care providers, hospital

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Authors: Sara Ataei, Molouk Hadjibabaie, Amirhossein Moslehi, Maryam Taghizadeh-Ghehi, Asieh Ashouri, Elham Amini, Kheirollah Gholami, Alireza Hayatshahi, Mohammad Vaezi, Ardeshir Ghavamzadeh

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Acute kidney injury (AKI) is one of the complications of hematopoietic stem cell transplantation and is associated with increased mortality. N-acetylcysteine (NAC) is a thiol compound with antioxidant and vasodilatory properties that has been investigated for the prevention of AKI in several clinical settings. In the present study, we evaluated the effects of intravenous NAC on the prevention of AKI in allogeneic hematopoietic stem cell transplantation patients. A double-blind randomized placebo-controlled trial was conducted, and 80 patients were recruited to receive 100 mg/kg/day NAC or placebo as intermittent intravenous infusion from day -6 to day +15. AKI was determined on the basis of the Risk-Injury-Failure-Loss-Endstage renal disease and AKI Network criteria as the primary outcome. We assessed urine neutrophil gelatinase-associated lipocalin (uNGAL) on days -6, -3, +3, +9, and +15 as the secondary outcome. Moreover, transplant-related outcomes and NAC adverse reactions were evaluated during the study period. Statistical analysis was performed using appropriate parametric and non-parametric methods including Kaplan–Meier for AKI and generalized estimating equation for uNGAL. At the end of the trial, data from 72 patients were analyzed (NAC: 33 patients and placebo: 39 patients). Participants of each group were not different considering baseline characteristics. AKI was observed in 18% of NAC recipients and 15% of placebo group patients, and the occurrence pattern was not significantly different (p = 0.73). Moreover, no significant difference was observed between groups for uNGAL measures (p = 0.10). Transplant-related outcomes were similar for both groups, and all patients had successful engraftment. Three patients did not tolerate NAC because of abdominal pain, shortness of breath and rash with pruritus and were dropped from the intervention group before transplantation. However, the frequency of adverse reactions was not significantly different between groups. In conclusion, our findings could not show any clinical benefits from high-dose NAC particularly for AKI prevention in allogeneic hematopoietic stem cell transplantation patients.

Keywords: acute kidney injury, N-acetylcysteine, hematopoietic stem cell transplantation, urine neutrophil gelatinase-associated lipocalin, randomized controlled trial

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Authors: Abdoullah Nyassi, Golam Sarwar, Sarra Baldeh, Mamadou S. K. Jallow, Bai Lamin Dondeh, Isaac Osei, Grant A. Mackenzie

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A randomized controlled trial is the "gold standard" for evaluating the efficacy of an intervention. Large-scale, cluster-randomized trials are expensive and difficult to conduct, though. To guarantee the validity and generalizability of findings, high-quality, dependable, and accurate data management systems are necessary. Robust data management systems are crucial for optimizing and validating the quality, accuracy, and dependability of trial data. Regarding the difficulties of data gathering in clinical trials in low-resource areas, there is a scarcity of literature on this subject, which may raise concerns. Effective data management systems and implementation goals should be part of trial procedures. Publicizing the creative clinical data management techniques used in clinical trials should boost public confidence in the study's conclusions and encourage further replication. In the ongoing pneumococcal vaccine schedule study in rural Gambia, this report details the development and deployment of multi-data management systems and methodologies. We implemented six different data management, synchronization, and reporting systems using Microsoft Access, RedCap, SQL, Visual Basic, Ruby, and ASP.NET. Additionally, data synchronization tools were developed to integrate data from these systems into the central server for reporting systems. Clinician, lab, and field data validation systems and methodologies are the main topics of this report. Our process development efforts across all domains were driven by the complexity of research project data collected in real-time data, online reporting, data synchronization, and ways for cleaning and verifying data. Consequently, we effectively used multi-data management systems, demonstrating the value of creative approaches in enhancing the consistency, accuracy, and reporting of trial data in a poor resource setting.

Keywords: data management, data collection, data cleaning, cluster-randomized trial

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Authors: Jing Ding

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The present study will propose a Randomized Controlled Trial (RCT) that will assess the efficacy of group Cognitive Behavioral Therapy (CBT) in treating depressive symptoms among menopausal women in China. Considering the high prevalence of menopausal symptoms and depressive disorders among this population, the present study is intended to explore whether group CBT can provide relief for these psychological disturbances commonly linked with hot flashes and night sweats during menopause. Thus, participants will be recruited through gynecologic and psychological outpatient clinics in Beijing, China, and then randomly assigned to either the CBT intervention group or the waitlist control group. The primary outcome measures for major depression will include the PHQ-9, while for menopausal symptoms, the main outcome measure will be the KMI. Secondary measures will include the assessment of sleep quality, quality of life, and general well-being. The current study offers evidence-based intervention for non-pharmacological menopausal symptoms in women and underlines the benefits that group CBT can have, both at a mental health level and for physical symptoms during menopause. This study could set the stage for the wider clinical practice of CBT with this demographic.

Keywords: group CBT, depression, women's mental health, menopause

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