Effectiveness of a specialist palliative home care nurse–patient consultation followed by an interprofessional telephone case conference compared with usual care among patients with non-oncological palliative care needs: protocol for the multicentre KOPAL cluster-randomised controlled trial by Judith Dams, Hans-Helmut König, Tim Friede, Nils Schneider, Stephanie Stiel, Martin Scherer, Silke Böttcher, Gabriella Marx, Ingmar Schäfer, Nadine Janis Pohontsch, Hendrik van den Bussche, Friedemann Nauck, Michael Freitag, Eva Hummers, Tina Mallon, Franziska Schade, Manuel Zimansky, Thomas Asendorf, Christiane A Mueller

“…The KOPAL study (a concept for strenghtening interprofessional collaboration for patients with palliative care needs) will test the effectiveness of a SPHC nurse–patient consultation followed by an interprofessional telephone case conference.Methods and analysis Multicentre two-arm cluster randomised controlled trial KOPAL with usual care as control arm. …”
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Adaptive clinical trial of AZD7442 and SARS-CoV-2 vaccination in immunosuppressed patients highly vulnerable to infection with SARS-CoV-2 virus (RAPID-PROTECTION): protocol for a multicentre, interventional open-label, randomised controlled trial by Ernest Choy, Kerenza Hood, Emma Thomas-Jones, Eleanor Barnes, Keith Wilson, Christian H Ottensmeier, Debbie Harris, Adrian Hill, Mark Tuthill, Richard Adams, Catherine Porter, Katie Ewer, Sian Griffin, Rebecca Tangney, Joanne Euden, Shirley Pringle, Lawrence Raisanen, Ruby Ray, Lisette Sheena Nixon, Melanie Varley, Craig Bodman, Paola Cicconi, Vivien Dagley, Steven Knapper

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Study protocol for a pragmatic randomised controlled trial of comparing enhanced acceptance and commitment therapy plus (+) added to usual aftercare versus usual aftercare only, in patients living with or beyond cancer: SUrvivors’ Rehabilitation Evaluation after CANcer (SURECAN) trial by Imran Khan, Stephanie J. C. Taylor, Clare Robinson, Elisavet Moschopoulou, Paul McCrone, Liam Bourke, Mohamed Thaha, Kamaldeep Bhui, Derek Rosario, Damien Ridge, Sheila Donovan, Ania Korszun, Paul Little, Adrienne Morgan, Olivier Quentin, Rebecca Roylance, Peter White, Trudie Chalder

“…Methods We will conduct a multi-centre, pragmatic, theory driven, randomised controlled trial. We will assess whether ACT+ including usual aftercare (intervention) is more effective and cost-effective than usual aftercare alone (control). …”
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Treating common mental disorder including psychotic experiences in the primary care improving access to psychological therapies programme (the TYPPEX study): protocol for a stepped wedge cluster randomised controlled trial with nested economic and process evaluation of a training package for therapists by David Fowler, Jesus Perez, Peter B Jones, Debra Russo, Clare Knight, Mary Dixon-Woods, Allan B Clark, Margaret Heslin, Sarah Byford, Paul French, Thomas Kabir, Jan Stochl, Mona Kanaan, James Clarke, Nick Grey, Ann Marie Swart, Polly-Anna Ashford, Ushma Patel, Freya Stuart, Hannah Murray, J Hodgekins, Nesta Reeve, Nicola Marshall, Michelle Painter, Maria Leathersich, Martin Pond

“…The Tailoring evidence-based psychological therapY for People with common mental disorder including Psychotic EXperiences study will evaluate the clinical and cost-effectiveness of an enhanced training for cognitive behavioural therapists that aims to address this clinical gap.Methods and analysis This is a multisite, stepped-wedge cluster randomised controlled trial. The setting will be IAPT services within three mental health trusts. …”
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Statistical analysis plan for a pragmatic randomised controlled trial comparing enhanced acceptance and commitment therapy plus ( +) added to usual aftercare versus usual aftercare only, in patients living with or beyond cancer: SUrvivors' Rehabilitation Evaluation after CANcer (SURECAN) trial by Clare Robinson, Trudie Chalder, Paul McCrone, Olivier Quintin, Evdoxia Gkaintatzi, Imran Khan, Stephanie J. C. Taylor, on behalf of the SURECAN GROUP

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Holistic health and social care outreach for people experiencing homelessness with recent non-fatal overdose in Glasgow, Scotland: the Pharmacist and third sector Homeless charity worker Outreach Engagement Non-medical Independent prescriber Rx (PHOENIx) pilot randomised controlled trial by Vibhu Paudyal, Nicola Greenlaw, Frances S Mair, Kate Stock, Andrew McPherson, Andrea E Williamson, Richard Lowrie, Donogh Maguire, Steven Ross, James Roy Robertson, Alison Boyle, Clare Duncan, Rebecca Blair, Cian Lombard, Fiona Hughes, Jane Moir, Ailsa Scott, Frank Reilly, Laura Sills, Jennifer Hislop, Stephen Wishart, David Brannan, Rebekah Ramage

“…Objectives To examine randomised controlled trial (RCT) progression criteria including emergency department (ED) attendance and non-fatal overdose, from a holistic, integrated health and social care outreach intervention (PHOENIx), for people experiencing homelessness with recent non-fatal street drug overdose.Design Pilot RCT. 1:1 randomisation to PHOENIx plus usual care (UC) or UC.Setting Glasgow, Scotland.Participants 128 adults experiencing homelessness with at least one non-fatal street drug overdose in the preceding 6 months.Interventions Pharmacists from the National Health Service and third sector homelessness workers offered weekly outreach. …”
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Protocol for a multicentre, prospective, open-label, randomised controlled trial to compare PROs and safety outcomes between preoperative and postmastectomy radiotherapy in locally advanced breast cancer patients with immediate reconstruction via a deep inferior epigastric perforator flap (CAPPELLA) in China by Li Zhang, Jiong Wu, Guangyu Liu, Shuang Hao, Jianjing Hou, Changming Zhou, Yifeng Hou, Keda Yu, Zhen Hu, Genhong Di, Zhi Min Shao, Xiaoli Yu

“…Further evaluation in a randomised trial comparing preoperative radiotherapy versus conventional PMRT in breast reconstruction is required to assess both oncological and patient-reported outcomes (PROs).Methods and analysis The CAPPELLA trial is a prospective, multicentre, open-label, randomised controlled trial across nine centres comparing PROs and safety outcomes between preoperative and postoperative radiotherapy in patients with locally advanced breast cancer requiring immediate DIEP flap reconstruction. …”
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Comparing propofol anaesthesia guided by Bispectral Index monitoring and frontal EEG wave analysis with standard monitoring in laparoscopic surgery: protocol for the ‘EEG in General Anaesthesia - More Than Only a Bispectral Index’ Trial, a multicentre, double-blind, randomised controlled trial by Luzius A Steiner, Salome Dell-Kuster, Bettina U Gruber, Valerie Girsberger, Lukas Kusstatscher, Simon Funk, Anita Luethy, Lien Jakus, Julien Maillard, Christoph S Burkhart

“…We hypothesise that quality of recovery (QoR) in patients undergoing laparoscopic surgery is better, if propofol is titrated by anaesthesia practitioners able to interpret the EEG.Methods and analysis This is a multicentre, double-blind (patients and outcome assessors) randomised controlled trial taking place in four Swiss hospitals. …”
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Protocol for a phase IV double-blind randomised controlled trial to investigate the effect of the 13-valent pneumococcal conjugate vaccine and the 23-valent pneumococcal polysaccharide vaccine on pneumococcal colonisation using the experimental human pneumococcal challenge model in healthy adults (PREVENTING PNEUMO 2) by Tao Chen, Duolao Wang, Konstantinos Liatsikos, Stephen B Gordon, Hassan Burhan, Ben Morton, Tinashe K Nyazika, Bradford D Gessner, Helen Hill, Andrea Collins, Josh Hamilton, Kelly Davies, Fred Fyles, Phoebe Hazenberg, Elizabeth Begier, Angela Hyder-Wright, Sherin Pojar, Christopher Myerscough, Jesus Reine, Ryan E Robinson, Britta Urban, Elena Mitsi, Carla Solorzano, Angela Quinn, Kaijie Pan, Annaliesa S Anderson, Christian Theilacker, Daniela M Ferreira, Kelly Convey, James Court, Madlen Farrar, Lisa Hitchins, Ashleigh Howard, Lauren Kerruish, Samuel Latham, Annabel Murphy, Elissavet Nikolaou, Angelina Peterson

“…Here, we summarise an ethically approved protocol for a double-blind, randomised controlled trial investigating the effect of the 13-valent pneumococcal conjugate vaccine (PCV13) and the 23-valent pneumococcal polysaccharide vaccine (PPV23) on pneumococcal nasopharyngeal colonisation acquisition, density and duration using experimental human pneumococcal challenge (EHPC).Methods and analysis Healthy adult participants aged 18–50 years will be randomised to receive PCV13, PPV23 or placebo and then undergo one or two EHPCs involving intranasal administration of SPN at 1-month post-vaccination with serotype 3 (SPN3) and 6 months with serotype 6B (SPN6B). …”
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Investigation of the effects of combined exercises and self-management education, with and without functional exercises, on pain and functional outcomes in patients with avascular necrosis of the femoral head: a protocol for a single-blind, randomised controlled trial with a parallel design and a 4 month follow-up by Zohreh Gholami, Seyedeh Tahereh Faezi, Elham Madreseh, Raghad Mimar

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Implementing a nurse-enabled, integrated, shared-care model involving specialists and general practitioners in early breast cancer post-treatment follow-up (EMINENT): a single-centre, open-label, phase 2, parallel-group, pilot, randomised, controlled trialResearch in context by Raymond J. Chan, Fiona Crawford-Williams, Chad Yixian Han, Lee Jones, Alexandre Chan, Daniel McKavanagh, Marissa Ryan, Christine Carrington, Rebecca L. Packer, Megan Crichton, Nicolas H. Hart, Emma McKinnell, Melissa Gosper, Juanita Ryan, Bethany Crowe, Ria Joseph, Carolyn Ee, Jane Lee, Steven M. McPhail, Katharine Cuff, Laisa Teleni, Jon Emery

“…Methods: In this single-centre, open-label, phase II, pilot, randomised, controlled trial, individuals diagnosed with breast cancer (Stage 0–III) were randomised 1:1 to either usual care or intervention, which includes a 1) Specialist Nurse Consultation to co-develop a survivorship care plan (SCP), 2) Pharmacist Consultation, 3) Case Conference with General Practitioner (GP), and 4) shared follow-up care arrangements. …”
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The Taking Charge After Stroke (TaCAS) study protocol: a multicentre, investigator-blinded, randomised controlled trial comparing the effect of a single Take Charge session, two Take Charge sessions and control intervention on health-related quality of life 12 months after stroke for non-Māori, non-Pacific adult New Zealanders discharged to community living by Mark Weatherall, Harry McNaughton, Vivian Wai Yin Fu

“…However, there is limited information on the generalisability and optimum dose of these interventions.Methods The Taking Charge After Stroke (TaCAS) study is a multicentre, investigator-blinded, randomised controlled trial recruiting 400 participants following acute stroke from seven hospitals in New Zealand. …”
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Lay Health Trainers Supporting Self-Management amongst Those with Low Heath Literacy and Diabetes: Lessons from a Mixed Methods Pilot, Feasibility Study by Bernadette Bartlam, Trishna Rathod, Gillian Rowlands, Joanne Protheroe

“…This article reports a mixed methods process evaluation of a pilot feasibility randomised controlled trial comparing a Lay Health Trainer (LHT) intervention and usual care for those with poorly controlled Type 2 Diabetes Melitus (T2DM). …”
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Zoledronic acid as adjuvant therapy in neovascular age-related macular degeneration: a randomised controlled pilot study by Øystein Kalsnes Jørstad, Morten Carstens Moe, Morten Wang Fagerland, Yngvil Solheim Husum, Erik Fink Eriksen

“…There were no between-group differences in mean change in central retinal thickness, refractory nAMD proportion or mean number of injections.Conclusion It is feasible to conduct a randomised controlled trial of ZA as adjuvant therapy for nAMD in terms of recruitment and adherence to the pilot study protocol. …”
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Prevention of Postoperative Events following Reversal with Sugammadex or Neostigmine (the P-PERSoN Trial): Pilot Data Following Early Termination of a Prospective, Blinded, Randomi... by Benjamin Olesnicky, Matthew Doane, Clare Farrell, Greg Knoblanche, Anthony Delaney

“…We support the need for an adequately resourced and funded randomised controlled trial to address this important clinical question.…”
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Socket Preservation Using Platelet-Rich Fibrin and Free Gingival Grafts by Haya Hesham Abdel-Latif Afifi, Shaimaa Saieed Nasr, Munerah Saleh BinShabaib, Shatha Subhi Alharthi, Mona Shoeib

“…Methods: This study is a parallel-arm randomised controlled trial. Patients in the test and control groups underwent SP using PRF and FGG, respectively. …”
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Effect of integrated case-based and problem-based learning on clinical thinking skills of assistant general practitioner trainees: a randomized controlled trial by Dingyuan Jiang, Danpei Huang, Hua Wan, Wuliang Fu, Weidong Shi, Jin Li, Huan Zou, Niannan Hou, Qing Li, Nani Li

“…Methods This randomised controlled trial involved 70 second-year AGP trainees who were randomly assigned to either the CBL-PBL group or the LBL group using a simple randomisation method. …”
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Hydrophobic and Hydrophilic IOLs in Patients with Uveitis – A Randomised Clinical Trial by Pålsson S, Schuborg C, Sterner B, Andersson Grönlund M, Zetterberg M

“…Improvement in vision and possible complications vary depending on the type of replacement lens used. This randomised controlled trial compares inflammation, improvement in vision, and possible complications in patients that received two differing types of intraocular lenses. …”
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Challenges and opportunities in enhanced recovery after surgery programs: An overview by Vijaya Gottumukkala, Girish P. Joshi

“…Finally, research methodologies should focus on controlling for adherence to the core elements of the pathways and testing for the effectiveness of an individual intervention in a randomised controlled trial.…”
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How Physically Active Are People with Stroke in Physiotherapy Sessions Aimed at Improving Motor Function? A Systematic Review by Gurpreet Kaur, Coralie English, Susan Hillier

“…Seven studies were included; six observational and one randomised controlled trial. People with stroke were found to be physically active for an average of 60 percent of their physiotherapy session duration. …”
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