The impact of universal mental health screening on stigma in primary schools by Annabel Songco, Deanna A. Francis, Emma A. McDermott, Chloe Y. S. Lim, Abigail Allsop, Joseph Croguennec, Gemma Sicouri, Andrew Mackinnon, Jennifer L. Hudson

“…Methods Across 6 primary schools, a cluster randomised controlled trial allocated schools to one of two conditions. …”
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Comparison of two skin protection regimes for the Prevention of Incontinence-associated Dermatitis in geriatric care (PID): a study protocol for an exploratory randomised controlle... by Jan Kottner, Monira El Genedy-Kalyoncu, Alexandra Fastner, Bettina Völzer, Kathrin Raeder, Konrad Neumann, Nils Axel Lahmann

“…IAD incidence of the control and intervention groups will be compared to estimate effect sizes, and the procedural feasibility of the intervention will be tested to plan a possible subsequent confirmatory randomised controlled trial.Ethics and dissemination The study received the approval of the ethics committee of Charité–Universitätsmedizin Berlin (EA4/043/22). …”
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Development and validation of the Multimorbidity Treatment Burden Questionnaire (MTBQ) by Daisy Gaunt, Chris Salisbury, Mei-See Man, Katherine Chaplin, Polly Duncan, Mairead Murphy

“…The scale was piloted and the final version was tested in 1546 adults with multimorbidity (mean age 71 years) who took part in the 3D Study, a cluster randomised controlled trial. For each question, we examined the proportion of missing data and the distribution of responses. …”
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Attitudes and adherence to changes in nutrition and physical activity following surgery for prostate cancer: a qualitative study by Richard M Martin, Raj Persad, J Athene Lane, Ellie Shingler, Luke A Robles, Edward Rowe, Anthony Koupparis, Amit Bahl, Constance Shiridzinomwa, Lucy McGeagh

“…We aimed to explore these factors in men following prostatectomy for prostate cancer (PCa).Design, setting and participants A qualitative study using semistructured interviews with men, who made changes to their diet and/or PA as part of a factorial randomised controlled trial conducted at a single hospital in South West England. …”
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Melatonin supplementation for the treatment of infantile spasms: protocol for a randomised placebo-controlled triple-blind trial by Jing Wang, Tao Xu, Miao Liu, Jian Chen, Guang Yang, Weiwei Feng, Yulin Sun, Xiuyu Shi, Liping Zou

“…This study aims to analyse the therapeutic effect of melatonin supplementation for the treatment of IS.Methods and analysis This is a triple-blinded (trial participant, outcome assessor and the data analyst), prospective, randomised controlled trial to be conducted in the Department of Paediatrics, The First Medical Center of Chinese PLA General Hospital, Beijing, China from November 2020. …”
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The Impact of Chronic Pelvic Pain and Bowel Morbidity on Quality of Life in Cervical Cancer Patients Treated With Radio (Chemo) Therapy. A Systematic Literature Review by Natuhwera G, Ellis P

“…Data were extracted using a structured checklist designed to capture key elements about the methods and findings of the research.Results: There were 245 articles retrieved with 29 meeting the inclusion criteria. 11 studies were conducted in Europe, eight in Asia, one in North America, three in Africa, while six were multinational/multicontinental. 13 of the papers were longitudinal, 10 cross-sectional, three literature reviews, one open randomised controlled trial, and two retrospective studies of prospectively collected data. …”
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Cognitive behavioural therapy plus Kiesler Circle Training (CBT+) versus CBT only for patients with interpersonal problems: study protocol for a randomised controlled feasibility t... by Stephan Köhler, Philipp Sterzer, Eva-Lotta Brakemeier, Karen Ollrogge, Daniel Schulze, Eva Friedel, Nina Romanczuk-Seiferth, Anna-Lena Siegerist, Anne Guhn

“…This study aims to evaluate the efficacy and feasibility of a transdiagnostic group intervention, the Kiesler Circle Training (KCT), in improving interpersonal skills.Methods and analysis In a prospective randomised controlled trial (RCT), 156 outpatients with a primary diagnosis of either depression or anxiety disorder according to DSM-5, and significant interpersonal problems, will be investigated. …”
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Refreshing medical students’ intravenous-cannulation skills: a blinded observer three-arm randomised comparison of mental imagery, part-task trainer simulation and written instruct... by Robert Greif, Joana Berger-Estilita, Rafael Blülle, Daniel Stricker, Mathias Balmer, Christoph Berendonk

“…This study investigates the effectiveness of three educational strategies used to refresh the intravenous cannulation skills of first-year medical students: mental imagery, part-task trainer simulation and written instructions.Materials and methods In this single-centre randomised controlled trial, first-year medical students were assigned to one of three different refresher tutorials on intravenous cannulation. …”
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Randomised feasibility study of an intestinal adsorbent in acute diarrhoea in The Gambia by Elena Markaryan, Matthew Dodd, Stephen Allen, Carol Howell, Angela Allen, Paul Rahden, Abdoulie Fatty, Momodou Lamin Jobarteh, Abdoulwahab Sallah, Ebrahim Jaiteh, Doreen Umoh, Fanta Bass, Radovan Hnatič

“…One serious event (death) occurred in the control arm.Conclusions A randomised, controlled trial is feasible. Further clinical trials are warranted to confirm the efficacy of polymethylsiloxane polyhydrate in acute diarrhoea and inform management guidelines.Trial registration number PACTR202302683128875.…”
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The Effectiveness of Acupuncture on Myofascial Trigger Points Versus Traditional Chinese Medicine Acupoints for Treating Plantar Fasciitis With Low Back Pain: A Study Protocol for... by Huang Z, Liang X, Luo Y, Fang Z, Xu M, Xu Y, Cheng S, Li L

“…This trial aims to compare the effectiveness of acupuncture at trigger points versus Traditional Chinese Medicine (TCM) acupoints in the treatment of participants with plantar fasciitis and low back pain.Methods: The trial will be a single-centre, parallel two-group, randomised controlled trial with 62 participants allocated in a 1:1 ratio to either the trigger point group or the TCM acupoint group. …”
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Structured follow-up pathway to support people after transient ischaemic attack and minor stroke (SUPPORT TIA): protocol for a feasibility study and process evaluation by Grace M Turner, Melanie Calvert, Sue Jowett, Robbie Foy, Jonathan Mant, Sarah Tearne, Lou Atkins, Rachael Jones, Smitaa Patel, Phillip Collis

“…The study aims to assess the feasibility and acceptability of (1) the intervention and (2) the trial procedures for a future randomised controlled trial of this intervention.Methods and analysis This is a multicentre, randomised (1:1) feasibility study with a mixed-methods process evaluation. …”
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Procedural sedative effect of remimazolam in ICU patients on invasive mechanical ventilation: a randomised, prospective study by Youli Tian, Jintong Li, Minggen Jin, YiHua Piao, Jisheng Sheng, Zhixiong Mei, Qingsong Cui, Lilin Li

“…Methods In this single-centre randomised controlled trial, intubated patients were randomly assigned to the remimazolam group or the propofol group. …”
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Action Imagery and Observation in Neurorehabilitation for Parkinson’s Disease (ACTION-PD): Development of a User-Informed Home Training Intervention to Improve Functional Hand Move... by Judith Bek, Paul S. Holmes, Chesney E. Craig, Zoë C. Franklin, Matthew Sullivan, Jordan Webb, Trevor J. Crawford, Stefan Vogt, Emma Gowen, Ellen Poliakoff

“…Preliminary data on feasibility were obtained via a six-week pilot randomised controlled trial (ISRCTN 11184024) of 10 participants with mild to moderate PD (6 intervention; 4 treatment as usual). …”
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Cross-agency working when conducting a pragmatic RCT for older victims of crime: our experiences and lessons learned by Marc Serfaty, Jessica Satchell, Gloria K. Laycock, Chris R. Brewin, Marta Buszewicz, Gerard Leavey, Vari M. Drennan, Jonathan Cooke, Anthony Kessel

“…Our recent Victim Improvement Package (VIP) randomised controlled trial (RCT) involved cross-agency collaboration between our university, a police service and a mental health charity. …”
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Barriers and enablers to recruiting participants within paediatric perioperative and anaesthetic settings: lessons learned from a trial of melatonin versus midazolam in the premedi... by Marie C. Hyslop, Diana E. Papaioannou, Robert Bolt, Matthew J. Wilson, Michael Bradburn, Janet Clarkson, Esther Herbert, Nicholas Ireland, Jennifer Kettle, Amanda Loban, Amy C. Norrington, Christopher Vernazza, Christopher Deery

“…Background: Poor recruitment is one key reason for premature closure of randomised controlled trials. The Melatonin for Anxiety prior to General Anaesthesia In Children (MAGIC) trial was a multicentre randomised controlled trial of melatonin vs midazolam in the premedication of anxious children, before surgery. …”
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Symptom patterns in patients newly sick listed for common mental disorders and associations with work-related and socioeconomic factors: a cross-sectional study in Swedish primary... by Cecilia Björkelund, Dominique Hange, Eva-Lisa Petersson, Irene Svenningsson, Nashmil Ariai, Lilian Wiegner

“…Objective The aim was to determine symptom patterns of depression, anxiety and stress-related mental disorders in newly sick listed due to common mental disorders in Swedish primary care patients and to examine associations with sick leave diagnosis, also in relation to socioeconomic, work-related and demographic factors.Design Cross-sectional study.Setting Primary care in western Sweden.Participants From a randomised controlled trial, patients aged 18–67, seeking primary care and on sick leave due to depression, anxiety and/or mental stress, in total 341 individuals, during 2018–2020.Primary outcome measures Patterns of depressive, anxiety and stress symptoms measured via self-assessment questionnaires (Montgomery Asberg Depression Rating Scale-Self (MADRS-S), General Anxiety Disorder Scale-7 (GAD-7), Karolinska Exhaustion Disorder Scale (KEDS)), sick leave diagnosis, perception of Work Ability Index and job strain via the job strain model.Results A combination of high levels of depressive and stress-related symptoms was more frequent than single symptom clusters among persons with common mental disorders (CMD) on sick leave: 7% of the patients had scores above cut-off for one of the instruments MADRS-S, GAD-7 and KEDS, 12% above cut-off for two and 80% had above cut-off for all three instruments. …”
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Assessing the use of geospatial data for immunization program implementation and associated effects on coverage and equity in the Democratic Republic of Congo by Dosithée Ngo-Bebe, Patricia Mechael, Fulbert Nappa Kwilu, Théophane Kekemb Bukele, Félicité Langwana, Genèse Lolimo Lobukulu, Marcelo Ilunga Kalonji, Bahindwa Kalalizi, Kevin Tschirhart, Christophe Lungayo Luhata, Carine Gachen

“…Trial registration The study was registered and given BMC Central International Standard. Randomised Controlled Trial Number ISRCTN65876428 on March 11, 2021.…”
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Evaluation of two electronic-rehabilitation programmes for persistent knee pain: protocol for a randomised feasibility trial by Philip G Conaghan, Kim L Bennell, Mark Conner, Rana S Hinman, Sarah R Kingsbury, Elizabeth M A Hensor, Gretl A McHugh, Christine Comer, Dawn Groves-Williams, Rachel K Nelligan

“…If considered feasible and acceptable, a definitive randomised controlled trial can be conducted to investigate the clinical effectiveness and cost-effectiveness of one or both interventions with a view to implementation in routine care.Ethics and dissemination The trial was approved by the West of Scotland Research Ethics Committee 5 (Reference: 20/WS/0006). …”
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Efficacy, efficiency and safety of a cardiac telerehabilitation programme using wearable sensors in patients with coronary heart disease: the TELEWEAR-CR study protocol by Andrew Xanthopoulos, Eleni Kapreli, Garyfallia Pepera, Konstantinos I Gourgoulianis, Varsamo Antoniou, Gregory Giamouzis, Constantinos Davos, Ladislav Batalik, Vasileios Stavrou, John Skoularigis

“…This study will investigate the efficacy, efficiency, safety and cost-effectiveness of a telerehabilitation programme based on objective exercise telemonitoring and evaluation of cardiorespiratory fitness.Methods and analysis A supervised, parallel-group, single-blind randomised controlled trial will be conducted. A total of 124 patients with coronary disease will be randomised in a 1:1 ratio into two groups: intervention telerehabilitation group (TELE-CR) (n=62) and control centre-based cardiac rehabilitation group (CB-CR) (n=62). …”
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Acceptance commitment therapy (ACT) for psychological distress associated with inflammatory bowel disease (IBD): protocol for a feasibility trial of the ACTforIBD programme by Richard Gearry, Matthew Fuller-Tyszkiewicz, Andrew McCombie, Peter Gibson, Simon Knowles, Lisa Olive, Antonina Mikocka-Walus, Subhadra Evans, Leanne Raven, Daniel Romano, Eric O, Madeleine Dober, Leesa van Niekerk, Susan Chesterman

“…This study aims to evaluate the feasibility and preliminary efficacy of ACTforIBD to reduce psychological distress in patients with IBD. Using a randomised controlled trial, 25 participants will be randomised to ACTforIBD, and 25 patients to an active control condition.Ethics and dissemination This protocol has been approved by Deakin University Research Ethics Committee in September 2021 (Ref. 2021-263) and the New Zealand Central Health and Disability Ethics Committee in December 2021 (Ref. 2021 EXP 11384). …”
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