Protocol for the economic evaluation of metacognitive therapy for cardiac rehabilitation participants with symptoms of anxiety and/or depression by Patrick Doherty, David Reeves, Gemma E Shields, Adrian Wells, Lora Capobianco, Anthony Heagerty, Deborah Buck, Linda M Davies

“…The PATHWAY Group MCT study has been prospectively designed to collect comprehensive self-reported resource use and health outcome data, including the EQ-5D, within a randomised controlled trial study design (UK Clinical Trials Gateway). …”
Get full text

Nissen-Sleeve procedure versus laparoscopic Roux-en-Y gastric bypass in patients with morbid obesity and gastro-oesophageal reflux disease: protocol for a non-inferiority randomise... by Jan A Apers, Martin Dunkelgrun, Ivonne Leeuwenburgh, Judith W H 't Hart, Bo J Noordman, Laser U Biter

“…The aim of this study is to compare effectiveness of Nissen-Sleeve with LRYGB.Method and analysis This is a single-centre, phase III, parallel-group randomised controlled trial in a high-volume bariatric centre in the Netherlands. …”
Get full text

Health profile of residents of retirement villages in Auckland, New Zealand: findings from a cross-sectional survey with health assessment by Kathy Peri, Michal Boyd, Martin J Connolly, Joanna B Broad, Dale Bramley, Zhenqiang Wu, Katherine Bloomfield, Joanna Hikaka, Annie Tatton, Cheryl Calvert, Ann-Marie Higgins

“…The cohort formed will also be used for a longitudinal study and a randomised controlled trial. Village managers (sometimes after consulting residents) decided if representative sampling could be undertaken in each village. …”
Get full text

Mixed-methods process evaluation of a proactive approach to healthcare in Parkinson’s disease—ParkProReakt: a protocol of a hybrid efficacy-implementation study by Xinyu Huang, Max Geraedts, Elke Kalbe, Carsten Eggers, David José Pedrosa, Ann-Kristin Folkerts, Marcin Grzegorzek, Marlena van Munster, Johanne Stümpel, Natalie Altschuck, Ingmar Wellach, Hannes Boebinger, Anna Pedrosa, Kati Niemand, Dirk Becker, Nicole Pohlschmidt, Isabel Doblinger, Kristina Schmidt, Daniel Wolferts, Marius Nisslmueller, Gennet Beer, Mohammad Osman Ashraf, Florian Eberhardt, Rebecca Wichartz, Birgit Samans, Volker Gross, Keywan Sohrabi, Linda Kerkemeyer, Uemran Seven, Paulina Olgemoeller, Artur Piet, Mona Irsfeld, Marlena van Munster

“…This study protocol describes the process evaluation within a randomised clinical trial to assess the implementation and its impact on patient health outcomes of ParkProReakt—a proactive, multidisciplinary, digitally supported care model for community-dwelling PwPD.Methods and analysis The hybrid efficacy-implementation study will assess key implementation outcomes using the Medical Research Council framework for complex interventions alongside a randomised controlled trial. A combination of quantitative and qualitative methods will be used to assess process data from care providers and patients. …”
Get full text

Transition to home after very preterm birth: improving outcomes of children and their families—a systematic review protocol by Beatrice Latal, Ulrike Held, Ursula Kiechl-Kohlendorfer, Sandra Siegfried, Vivienne Engel, Valentina Mauron-Papadimitriou, Lea Bührer, Laura Ebner, Lena Keller, Martina Gosteli

“…The most promising interventions will then be combined and used as the basis of a subsequent randomised controlled trial of a new transition-to-home intervention. …”
Get full text

Attributable risk factors for asymptomatic malaria and anaemia and their association with cognitive and psychomotor functions in schoolchildren of north-eastern Tanzania. by Geofrey Makenga, Vito Baraka, Filbert Francis, Daniel T R Minja, Samwel Gesase, Edna Kyaruzi, George Mtove, Swabra Nakato, Rashid Madebe, Sif R Søeborg, Kathrine H Langhoff, Helle S Hansson, Michael Alifrangis, John P A Lusingu, Jean-Pierre Van Geertruyden

“…This study was a comprehensive baseline survey, within the scope of a randomised, controlled trial on the effectiveness and safety of antimalarial drugs in preventing malaria and its related morbidity in schoolchildren. …”
Get full text

Evaluation of the protective efficacy of OlysetPlus ceiling nets for reduction of malaria incidence in children in Homa Bay County, Kenya: a cluster-randomised controlled study pro... by Daisuke Yoneoka, Jesse Gitaka, James Kongere, Wataru Kagaya, Akira Kaneko, Yura K Ko, Chim W Chan, Mariko Kanamori, Bernard N Kanoi, Gordon Odhiambo Okomo, Protus Omondi, Kelvin B Musyoka, Takatsugu Okai, Victor Opiyo, Jared Oginga, Samuel Mungai, Kibor K Keitany, Elijah Songok, Noboru Minakawa

“…With this proposed second trial, we aim to evaluate the impact of this tool in a different eco-epidemiological setting in the lake endemic region of Kenya.Methods A cluster-randomised controlled trial is designed to evaluate the impact of pyrethroid-PBO ceiling nets in Ndhiwa Sub-County, Homa Bay County, Kenya. …”
Get full text

The Tools for Integrated Management of Childhood Illness (TIMCI) study protocol: a multi-country mixed-method evaluation of pulse oximetry and clinical decision support algorithms by Fenella Beynon, Hélène Langet, Leah F. Bohle, Shally Awasthi, Ousmane Ndiaye, James Machoki M’Imunya, Honorati Masanja, Susan Horton, Maymouna Ba, Silvia Cicconi, Mira Emmanuel-Fabula, Papa Moctar Faye, Tracy R. Glass, Kristina Keitel, Divas Kumar, Gaurav Kumar, Gillian A. Levine, Lena Matata, Grace Mhalu, Andolo Miheso, Deusdedit Mjungu, Francis Njiri, Elisabeth Reus, Michael Ruffo, Fabian Schär, Kovid Sharma, Helen L. Storey, Irene Masanja, Kaspar Wyss, Valérie D’Acremont, TIMCI Collaborator Group

“…Health impact is assessed through: a pragmatic parallel group, superiority cluster randomised controlled trial (RCT), with primary care facilities randomly allocated (1:1) in India to pulse oximetry or control, and (1:1:1) in Tanzania to pulse oximetry plus CDSA, pulse oximetry, or control; and through a quasi-experimental pre-post study in Kenya and Senegal. …”
Get full text

Efficacy of Chinese traditional quadruple single pill combination versus valsartan/hydrochlorothiazide for the treatment of hypertension (COSPQ-BP): study protocol for randomised c... by Kai Liu, Yu Yan, Xin Zhang, Yanan Li, Yuanyuan Yao, Lu Liu, Runyu Ye, Si Wang, Xiangyu Yang, Xiaoping Chen, Shanshan Jia, Qingtao Meng, Xianghao Zuo

“…It is widely employed in primary medical institutions and has favourable efficacy, tolerability and cost-effectiveness.Methods and analysis The COSPQ-BP trial is a 12-week prospective randomised controlled trial to enrol 1332 patients with primary mild-to-moderate hypertension. …”
Get full text

An analytical cross-sectional study on optimal (timely or cumulative age-appropriate) routine childhood immunization coverage in the communities of Ebonyi state, Nigeria by Ugwu I. Omale, Cordis O. Ikegwuonu, Glory E. Nkwo, Chimaobi C. Iwegbulam, Louisa C. Ekwuazi, Chidinma I. Amuzie, Richard L. Ewah

“…This study was a baseline cross-sectional household survey within a cluster-randomised controlled trial and was conducted from July 2 to 16, 2022 among consenting mother–child pairs, in which the children were aged 5–23 months (subdivided into 5–11 and 12–23 months), in 16 randomly selected geographical clusters where the primary health care (PHC) facilities were providing maternal and child health care services including weekly routine childhood immunization. …”
Get full text

CHI study: protocol for an observational cohort study on ageing and mental health in community-dwelling older adults by Lei Feng, Lieng Hsi Ling, Qiushi Feng, Rachael Zhi Yi Lee, Junhong Yu, Iris Rawtaer, Patrick Finbarr Allen, Zhiming Bao, Jeong Kyu Lee, Chin Tat Lim, Leng Leng Thang, Thet Naing, D Y Wang, Kai Zhen Yap, EH Kua, Rathi Mahendran

“…The Community Health and Intergenerational study aims to holistically examine ageing in place by investigating the resilience and vulnerability factors of the ageing process in the biological, psychological and social domains within the environment.Methods and analysis Using a cohort multiple randomised controlled trial design, comprehensive health profiles of community-dwelling older adults will be collected. …”
Get full text

Long-term safety and sustained efficacy of bimekizumab in patients with ankylosing spondylitis (radiographic axial spondyloarthritis): 5-year results from BE AGILE (phase 2b) and i... by Sofia Ramiro, Désirée van der Heijde, Atul Deodhar, Xenofon Baraliakos, Denis Poddubnyy, Lianne S Gensler, Helena Marzo-Ortega, Natasha de Peyrecave, Victoria Navarro-Compán, Tetsuya Tomita, Carmen Fleurinck, Ute Massow, Thomas Vaux

“…Objective Assess long-term safety, tolerability and efficacy of bimekizumab in ankylosing spondylitis (radiographic axial spondyloarthritis (r-axSpA)).Methods Patients with active r-axSpA completing the dose-ranging 48-week randomised controlled trial could enrol in the open-label extension, where patients received bimekizumab 160 mg every 4 weeks. …”
Get full text

Protocol for a feasibility study and process evaluation of a psychosocially modelled diabetes education programme for young people with type 1 diabetes: the Youth Empowerment Skill... by Nick Sevdalis, Khalida Ismail, Tayana Soukup, Trevor Murrells, Dulmini Kariyawasam, Stephen Thomas, Judith Parsons, Angus Forbes, Rita Forde, Maria Baldellou Lopez, Marie Jones, Martha Ford-Adams, Nardos Yemane, Siobhan Pender, Alex Silverstien

“…We will conduct a feasibility randomised controlled trial (waiting-list design) with integrated process evaluation. …”
Get full text

Mamá Empoderada: study protocol for a pilot trial of a novel parenting and mental health prevention intervention for migrant mothers with young children at the Mexico-US border by Gudelia Rangel, Shira M Goldenberg, Eileen Pitpitan, Kaylee Ramage, Ietza Bojorquez-Chapela, Cecilia Martinez-Torteya, Katherine Rosenblum, Chelsie Hernandez, Monica Alvarez

“…We have recently adapted this intervention for MMC in Mexico and will conduct a pilot randomised controlled trial (RCT) of the intervention with MMC (n=100; Ntreatment=50; Ncontrol=50). …”
Get full text

Identifying barriers and potential solutions to improve equitable access to community eye services: an exploratory sequential mixed methods study protocol by Min Kim, David Macleod, Michael Gichangi, Andrew Bastawrous, Matthew J Burton, Jacqueline Ramke, Oathokwa Nkomazana, Sailesh Mishra, Shalinder Sabherwal, Luke Nelson Allen, Abhishek Roshan, Sarah Karanja, Ari Ho-Foster, Keneilwe Motlhatlhedi, Nigel Bolster, Mohd Javed, Malebogo Tlhajoane, Bakgaki Ratshaa, John Tlhakanelo

“…The most promising service modifications will be implemented and evaluated in a follow-on randomised controlled trial, the methods for which will be reported elsewhere.Ethics and dissemination This project has been approved by independent research ethics committees in Botswana, Kenya, India, Nepal and the UK. …”
Get full text

Patients’ acceptability and implementation outcomes of a case management approach to encourage participation in colorectal cancer screening for people with schizophrenia: a qualita... by Tempei Miyaji, Yosuke Uchitomi, Hiroyuki Okada, Masatoshi Inagaki, Maiko Fujimori, Taichi Shimazu, Masaki Fujiwara, Masafumi Kodama, Ryuhei So, Takanori Matsushita, Yusaku Yoshimura, Shigeo Horii, Hirokazu Takahashi, Naoki Nakaya, Shiro Hinotsu, Keita Harada, Norihito Yamada, Yuto Yamada, Tsuyoshi Etoh

“…Simultaneously, the study aimed to determine the acceptability, appropriateness and feasibility of the intervention from the perspective of psychiatric care providers.Study design and setting This study was a secondary qualitative analysis of a mixed-method randomised controlled trial that evaluated the efficacy of the CM approach to encourage participation in cancer screening for people with schizophrenia. …”
Get full text

Antenatal pelvic floor muscle exercise intervention led by midwives in England to reduce postnatal urinary incontinence: APPEAL feasibility and pilot randomised controlled cluster... by Karla Hemming, Jonathan Bishop, Sarah Dean, Jean Hay-Smith, Tim Coleman, Elizabeth Edwards, Christine MacArthur, Debra Bick, Mark Pearson, Rohini Terry, Eivor Oborn, Sara Webb, Eleni Gkini, Victoria Salmon, Ellie Jones, Helena Frawley

“…Objectives To assess the feasibility of an intervention of midwifery support for antenatal pelvic floor muscle exercises (PFME) to prevent postnatal urinary incontinence (UI).Design Feasibility and pilot cluster randomised controlled trial. Clusters were community midwifery teams.Setting Community maternity antenatal care.Participants One hundred seventy-five women; 186 midwives.Intervention Midwifery training and resources for midwives and women to support antenatal PFME. …”
Get full text

Can nebulised heparin reduce acute lung injury in patients with SARS‑CoV‑2 requiring advanced respiratory support in Ireland: the CHARTER‑Ireland phase Ib/IIa, randomised, parallel... by David Cosgrave, Bairbre McNicholas, Ciara Hanley, John Robert Sheehan, Padraig Calpin, Maeve Kernan, Darragh Murphy, Alberto Alvarez‑Iglesias, John Ferguson, Camilla Giacomini, Christine Greene, Catriona Cody, Shane McGeary, Marion Murphy, Marianne Fitzgerald, Gerard Curley, Barry Dixon, Roger J. Smith, Claire Masterson, Daniel O’Toole, Frank van Haren, John G. Laffey

“…Methods This was a phase Ib/IIa open-label multi-centre, randomised controlled trial. The study was designed to evaluate whether nebulised unfractionated heparin decreased d-dimer concentrations, with safety as a co-primary outcome. …”
Get full text

Cost-effectiveness analysis of proactive home visits compared with site-based community health worker care on antenatal care outcomes in Mali: a cluster-randomised trial by Osondu Ogbuoji, Caroline Whidden, Emily Treleaven, Youssouf Keita, Kassoum Kayentao, Ari Johnson, Jenny X Liu, Minahil Shahid, Mohamed Berthé, Armand Zimmerman, David Charles Boettiger, Coumba Traoré, Mahamadou Sogoba, Saibou Doumbia, Amadou Beydi Cissé

“…However, despite the success of CHW programmes in various countries, WHO has called for additional research to develop evidence-based models that optimise CHW service delivery and that can be replicated across geographies.Methods The ProCCM Trial was a cluster-randomised controlled trial to compare proactive home visits by CHWs (intervention, 69 village clusters) to the provision of CHW care at community fixed sites only (control, 68 village clusters) in the Bankass health district in Central Mali. …”
Get full text

Evaluation of Modified Frailty Index-5 as a Predictor of 60-day Perioperative Morbidity and Mortality in Geriatric Patients Presenting for Orthopaedic Surgery: A Prospective Cohort... by Aparna Ashay Nerurkar, Amreen Fatima

“…Conclusion: Patients aged >65 years with mFI-5 scores ≥3, having CHF, DM, ASA grades >2, undergoing orthopaedic surgeries of duration up to three hours, had statistically significant chance of developing postoperative complications, other than death, up to 60 days. A randomised controlled trial with mFI-5 cut-off of ≥3 and longer follow-up periods would yield better results.…”
Get full text