Assessing the validity and reliability of self-report data on contraception use in the MObile Technology for Improved Family Planning (MOTIF) randomised controlled trial

Abstract Background Neuromuscular and quadriceps exercises have been shown to be effective approaches to relieve pain and to improve function for patients with knee osteoarthritis. In this study, we aim to provide an informative feasible model in which therapeutic exercise and education will be undertaken with physiotherapy supervision and instruction via video link. We also aim to explore the relationship between program-induced pain alleviation/functional improvements and reduction in irritability, which might be mediated through program-induced psychosocial benefits. Methods In this proposed two-parallel group (neuromuscular exercise versus quadriceps exercise), single-blinded, randomised controlled trial, participants aged ≥50 years with osteoarthritic knee pain will undergo a 12-week intervention, comprising video-linked education, supervised exercises, and a 12-week follow-up. Seven measurements will be taken to collect longitudinal data. A generalised estimating equation will be used to establish the adjusted difference in effectiveness on pain, function, irritability, and psychosocial outcomes between participants undertaking neuromuscular exercises and those undertaking quadriceps exercises. The primary outcomes are overall average pain in the knee joint during walking, as assessed through the 11-point Numerical Pain Rating Scale, and the Western Ontario and McMaster Universities osteoarthritis index physical function subscale. Furthermore, pressure pain threshold and changes in self-report pain scores pre-, during, and post-exercise were also measured as an indication of irritability. In addition, both the 6-min walk test and a timed up & go test were used to assess walking function performance. Finally, patients’ emotions (e.g., fear and catastrophising), self-trust, needs in terms of disease knowledge, mental resilience, social support and health-related quality of life were investigated. Two four-wave cross-lagged models will be used to investigate directional relationships, aiming to investigate the complex mechanisms concerning the effects of exercise programmes. Discussion Through summarising the study’s strengths and limitations, this study may provide promising insights in terms of exercise therapy optimisation for people with knee osteoarthritis and/or other chronic pain within a psychosocial framework. Trial registration ChiCTR2100041978 (chictr.org.cn), January 10, 2021.

Download Full-text

The impact of mobile technology devices on street checks and crime incidents reported: results of a randomised controlled trial

Journal of Experimental Criminology ◽

10.1007/s11292-021-09470-1 ◽

2021 ◽

Author(s):

Laura Bedford ◽

Lorraine Mazerolle ◽

John Gilmour ◽

Peter Martin

Keyword(s):

Randomised Controlled Trial ◽

Mobile Technology ◽

Controlled Trial ◽

Randomised Controlled ◽

The Impact

Download Full-text

Effectiveness of a hydrogel dressing as an analgesic adjunct to first aid for the treatment of acute paediatric burn injuries: a prospective randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-039981 ◽

2021 ◽

Vol 11 (1) ◽

pp. e039981

Author(s):

Maleea Denise Holbert ◽

Roy M Kimble ◽

Mark Chatfield ◽

Bronwyn R Griffin

Keyword(s):

Randomised Controlled Trial ◽

Repeated Measures ◽

Controlled Trial ◽

Geometric Mean ◽

First Aid ◽

Self Report ◽

Thermal Burn ◽

Pain Scores ◽

Registration Number ◽

Randomised Controlled

ObjectiveTo compare the effectiveness of two acute burn dressings, Burnaid hydrogel dressing and plasticised polyvinylchloride film, on reducing acute pain scores in paediatric burn patients following appropriate first aid.DesignSingle-centre, superiority, two-arm, parallel-group, prospective randomised controlled trial.Participants and settingPaediatric patients (aged ≤16) presenting to the Emergency Department at the Queensland Children’s Hospital, Brisbane, Australia, with an acute thermal burn were approached for participation in the trial from September 2017–September 2018.InterventionsPatients were randomised to receive either (1) Burnaid hydrogel dressing (intervention) or (2) plasticised polyvinylchloride film (Control) as an acute burn dressing.Primary and secondary outcomesObservational pain scores from nursing staff assessed 5 min post application of the randomised dressing, measured using the Face Legs Activity Cry and Consolability Scale was the primary outcome. Repeated measures of pain, stress and re-epithelialisation were also collected at follow-up dressing changes until 95% wound re-epithelialisation occurred.ResultsSeventy-two children were recruited and randomised (n=37 intervention; n=35 control). No significant between-group differences in nursing (mean difference: −0.1, 95% CI −0.7 to 0.5, p=0.72) or caregiver (MD: 1, 95% CI −8 to 11, p=0.78) observational pain scores were identified. Moreover, no significant differences in child self-report pain (MD: 0.3, 95% CI −1.7 to 2.2, p=0.78), heart rate (MD: −3, 95% CI −11 to 5, p=0.41), temperature (MD: 0.6, 95% CI −0.13 to 0.24, p=0.53), stress (geometric mean ratio: 1.53, 95% CI 0.93 to 2.53, p=0.10), or re-epithelialisation rates (MD: −1, 95% CI −3 to 1, p=0.26) were identified between the two groups.ConclusionsA clear benefit of Burnaid hydrogel dressing as an analgesic adjunct to first aid for the treatment of acute paediatric burns was not identified in this investigation.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12617001274369).

Download Full-text

A Randomised Controlled Trial of Strategies to Prompt Attendance for a Pap Smear

Journal of Medical Screening ◽

10.1177/096914139500200408 ◽

1995 ◽

Vol 2 (4) ◽

pp. 211-218 ◽

Cited By ~ 23

Author(s):

Jenny Bowman ◽

Rob Sanson-Fisher ◽

Catherine Boyle ◽

Stephanie Pope ◽

Sally Redman

Keyword(s):

At Risk ◽

Randomised Controlled Trial ◽

Pap Smear ◽

Controlled Trial ◽

Self Report ◽

Health Clinic ◽

Control Group ◽

Screening Attendance ◽

Randomised Controlled

Objective – To assess the comparative efficacy, by randomised controlled trial, of three interventions designed to encourage “at risk” women to have a Pap smear: an educational pamphlet; letters inviting attendance at a women's health clinic; and letters from physicians. Methods – Subjects at risk for cervical cancer who had not been adequately screened were identified by a random community survey and randomly allocated to one of the intervention groups or a control group. Six months after intervention implementation, a follow up survey assessed subsequent screening attendance. Self report was validated by comparison with a national screening data base. Results – A significantly greater proportion of women (36.9%) within the group receiving a physician letter reported screening at follow up than in any other group (P =0.012). The variables most strongly predicting screening attendance were: age, perceived frequency of screening required, use of oral contraceptives, and allocation to receive the physician letter intervention. Conclusions – The relative efficacy of the GP letter in prompting screening attendance shows that this strategy is worthy of further investigation. There remains a need to examine the barriers to screening for older women, and to develop tailored strategies for this population.

Download Full-text

Shoe cushioning, body mass and running biomechanics as risk factors for running injury: a study protocol for a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2017-017379 ◽

2017 ◽

Vol 7 (8) ◽

pp. e017379 ◽

Cited By ~ 10

Author(s):

Laurent Malisoux ◽

Nicolas Delattre ◽

Axel Urhausen ◽

Daniel Theisen

Keyword(s):

Risk Factors ◽

Randomised Controlled Trial ◽

Injury Prevention ◽

Body Mass ◽

Injury Risk ◽

Cox Regression ◽

Controlled Trial ◽

Study Groups ◽

Self Report ◽

Randomised Controlled

IntroductionRepetitive loading of the musculoskeletal system is suggested to be involved in the underlying mechanism of the majority of running-related injuries (RRIs). Accordingly, heavier runners are assumed to be at a higher risk of RRI. The cushioning system of modern running shoes is expected to protect runners again high impact forces, and therefore, RRI. However, the role of shoe cushioning in injury prevention remains unclear. The main aim of this study is to investigate the influence of shoe cushioning and body mass on RRI risk, while exploring simultaneously the association between running technique and RRI risk.Methods and analysisThis double-blinded randomised controlled trial will involve about 800 healthy leisure-time runners. They will randomly receive one of two running shoe models that will differ in their cushioning properties (ie, stiffness) by ~35%. The participants will perform a running test on an instrumented treadmill at their preferred running speed at baseline. Then they will be followed up prospectively over a 6-month period, during which they will self-report all their sports activities as well as any injury in an internet-based database TIPPS (Training and Injury Prevention Platform for Sports). Cox regression analyses will be used to compare injury risk between the study groups and to investigate the association among training, biomechanical and anatomical risk factors, and injury risk.Ethics and disseminationThe study was approved by the National Ethics Committee for Research (Ref: 201701/02 v1.1). Outcomes will be disseminated through publications in peer-reviewed journals, presentations at international conferences, as well as articles in popular magazines and on specialised websites.Trial registration numberNCT03115437, Pre-results.

Download Full-text

Evaluating the effectiveness of a group-based resilience intervention versus psychoeducation for emergency responders in England: A randomised controlled trial

PLoS ONE ◽

10.1371/journal.pone.0241704 ◽

2020 ◽

Vol 15 (11) ◽

pp. e0241704

Author(s):

Jennifer Wild ◽

Shama El-Salahi ◽

Michelle Degli Esposti ◽

Graham R. Thew

Keyword(s):

Mental Health ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Self Report ◽

Post Traumatic Stress ◽

Emergency Responders ◽

Significant Difference ◽

Randomised Controlled ◽

Resilience Intervention

Background Emergency responders are routinely exposed to traumatic critical incidents and other occupational stressors that place them at higher risk of mental ill health compared to the general population. There is some evidence to suggest that resilience training may improve emergency responders’ wellbeing and related health outcomes. The aim of this study was to evaluate the effectiveness of a tertiary service resilience intervention compared to psychoeducation for improving psychological outcomes among emergency workers. Methods We conducted a multicentre, parallel-group, randomised controlled trial. Minim software was used to randomly allocate police, ambulance, fire, and search and rescue services personnel, who were not suffering from depression or post-traumatic stress disorder, to Mind’s group intervention or to online psychoeducation on a 3:1 basis. The resilience intervention was group-based and included stress management and mindfulness tools for reducing stress. It was delivered by trained staff at nine centres across England in six sessions, one per week for six weeks. The comparison intervention was psychoeducation about stress and mental health delivered online, one module per week for six weeks. Primary outcomes were assessed by self-report and included wellbeing, resilience, self-efficacy, problem-solving, social capital, confidence in managing mental health, and number of days off work due to illness. Follow-up was conducted at three months. Blinding of participants, researchers and outcome assessment was not possible due to the type of interventions. Results A total of 430 participants (resilience intervention N = 317; psychoeducation N = 113) were randomised and included in intent-to-treat analyses. Linear Mixed-Effects Models did not show a significant difference between the interventions, at either the post-intervention or follow-up time points, on any outcome measure. Conclusions The limited success of this intervention is consistent with the wider literature. Future refinements to the intervention may benefit from targeting predictors of resilience and mental ill health. Trial registration ISRCTN registry, ISRCTN79407277.

Download Full-text

Joint observation in NICU (JOIN): study protocol of a clinical randomised controlled trial examining an early intervention during preterm care

BMJ Open ◽

10.1136/bmjopen-2018-026484 ◽

2019 ◽

Vol 9 (3) ◽

pp. e026484 ◽

Cited By ~ 2

Author(s):

Juliane Schneider ◽

Ayala Borghini ◽

Mathilde Morisod Harari ◽

Noemie Faure ◽

Chloé Tenthorey ◽

...

Keyword(s):

Early Intervention ◽

Randomised Controlled Trial ◽

Study Protocol ◽

Self Efficacy ◽

Maternal Mental Health ◽

Controlled Trial ◽

Self Report ◽

Parental Role ◽

Child Psychiatrist ◽

Randomised Controlled

IntroductionPreterm birth may generate significant distress among the parents, who often present with difficulties in appropriating their parental role. Parental stress and low perceived parental self-efficacy may interfere with the infant’s socioemotional and cognitive development, particularly through disrupted parent–infant interactions. Perceived parental self-efficacy represents the belief of efficacy in caring for one’s own infant and successful incarnation of the parental role, as well as the perception of one’s own abilities to complete a specified task. Interventions to support parental role, as well as infant development, are needed, and parental self-efficacy represents a useful indicator to measure the effects of such early interventions.Methods and analysisThis study protocol describes a randomised controlled trial that will test an early intervention in the neonatal intensive care unit (NICU) (JOIN: Joint Observation In Neonatology) carried out by an interdisciplinary staff team. Mothers of preterm neonates born between 28 and 32 6/7 weeks of gestational age are eligible for the study. The intervention consists of a videotaped observation by a clinical child psychologist or child psychiatrist and a study nurse of a period of care delivered to the neonate by the mother and a NICU nurse. The care procedure is followed by an interactive video guidance intended to demonstrate the neonate’s abilities and resources to his parents. The primary outcome will be the difference in the perceived maternal self-efficacy between the intervention and control groups assessed by self-report questionnaires. Secondary outcomes will be maternal mental health, the perception of the parent– infant relationship, maternal responsiveness and the neurodevelopment of the infant at 6 months corrected age.Ethics and disseminationEthical approval was granted by the Human Research Ethics Committee of the Canton de Vaud (study number 496/12). Results from this study will be disseminated at national and international conferences, and in peer-reviewed journals.Trial registration numberNCT02736136, Pre-results.

Download Full-text