Items where the Publication is Trials

Year Authors/Creators Item Type Full Text

2023

Clinical research for life-threatening illnesses requiring emergency hospitalisation: a critical interpretive synthesis of qualitative data related to the experience of participants and their caregivers. (2023) Lawrence, David S; Ssali, Agnes; Jarvis, Joseph N; Seeley, Janet

Complex and alternate consent pathways in clinical trials: methodological and ethical challenges encountered by underserved groups and a call to action. (2023) Russell, Amy M; Shepherd, Victoria; Woolfall, Kerry; Young, Bridget; Gillies, Katie; Volkmer, Anna; Jayes, Mark; Huxtable, Richard; Perkins, Alexander; Noor, Nurulamin M; Nickolls, Beverley; Wade, Julia

A comparison of covariate adjustment approaches under model misspecification in individually randomized trials. (2023) Tackney, Mia S; Morris, Tim; White, Ian; Leyrat, Clemence; Diaz-Ordaz, Karla; Williamson, Elizabeth

2022

Study protocol for a phase 1/2, single-centre, double-blind, double-dummy, randomized, active-controlled, age de-escalation trial to assess the safety, tolerability and immunogenicity of a measles and rubella vaccine delivered by a microneedle patch in healthy adults (18 to 40 years), measles and rubella vaccine-primed toddlers (15 to 18 months) and measles and rubella vaccine-naïve infants (9 to 10 months) in The Gambia [Measles and Rubella Vaccine Microneedle Patch Phase 1/2 Age De-escalation Trial]. (2022) Adigweme, Ikechukwu; Akpalu, Edem; Yisa, Mohammed; Donkor, Simon; Jarju, Lamin B; Danso, Baba; Mendy, Anthony; Jeffries, David; Njie, Abdoulie; Bruce, Andrew; Royals, Michael; Goodson, James L; Prausnitz, Mark R; McAllister, Devin; Rota, Paul A; Henry, Sebastien; Clarke, Ed

Intravenous versus oral iron for iron deficiency anaemia in pregnant Nigerian women (IVON): study protocol for a randomised hybrid effectiveness-implementation trial. (2022) Afolabi, Bosede B; Babah, Ochuwa A; Akinajo, Opeyemi R; Adaramoye, Victoria O; Adeyemo, Titilope A; Balogun, Mobolanle; Banke-Thomas, Aduragbemi; Quao, Rachel A; Olorunfemi, Gbenga; Abioye, Ajibola I; Galadanci, Hadiza S; Sam-Agudu, Nadia A

Safety and effectiveness of delivering mass drug administration for helminths through the seasonal malaria chemoprevention platform among Senegalese children: study protocol for a randomised controlled trial. (2022) Afolabi, Muhammed O; Sow, Doudou; Ndiaye, Jean Louis A; Greenwood, Brian

Protocol for an automated, pragmatic, embedded, adaptive randomised controlled trial: behavioural economics-informed mobile phone-based reminder messages to improve clinic attendance in a Botswanan school-based vision screening programme. (2022) Allen, Luke N; Ratshaa, Bakgaki; Macleod, David; Bolster, Nigel; Burton, Matthew; Kim, Min; Bastawrous, Andrew; Ho-Foster, Ari; Chroston, Hannah; Nkomazana, Oathokwa

Attractive targeted sugar bait phase III trials in Kenya, Mali, and Zambia. (2022) Attractive Targeted Sugar Bait Phase III Trial Group

TB-PRACTECAL: study protocol for a randomised, controlled, open-label, phase II-III trial to evaluate the safety and efficacy of regimens containing bedaquiline and pretomanid for the treatment of adult patients with pulmonary multidrug-resistant tuberculosis. (2022) Berry, Catherine; du Cros, Philipp; Fielding, Katherine; Gajewski, Suzanne; Kazounis, Emil; McHugh, Timothy D; Merle, Corinne; Motta, Ilaria; Moore, David AJ; Nyang'wa, Bern-Thomas

Postpartum haemorrhage in anaemic women: assessing outcome measures for clinical trials. (2022) Brenner, Amy; Roberts, Ian; Balogun, Eni; Bello, Folasade Adenike; Chaudhri, Rizwana; Fleming, Charlotte; Javaid, Kiran; Kayani, Aasia; Lubeya, Mwansa Ketty; Mansukhani, Raoul; Olayemi, Oladapo; Prowse, Danielle; Vwalika, Bellington; Shakur-Still, Haleema

The 2nd European Carotid Surgery Trial (ECST-2): rationale and protocol for a randomised clinical trial comparing immediate revascularisation versus optimised medical therapy alone in patients with symptomatic and asymptomatic carotid stenosis at low to intermediate risk of stroke. (2022) Cheng, Suk Fun; van Velzen, Twan J; Gregson, John; Richards, Toby; Jäger, Hans Rolf; Simister, Robert; Kooi, M Eline; de Borst, Gert J; Pizzini, Francesca B; Nederkoorn, Paul J; Brown, Martin M; Bonati, Leo H

Menstrual health interventions, schooling, and mental health problems among Ugandan students (MENISCUS): study protocol for a school-based cluster-randomised trial. (2022) Kansiime, Catherine; Hytti, Laura; Nelson, Kate Andrews; Torondel, Belen; Francis, Suzanna C; Tanton, Clare; Greco, Giulia; Belfield, Sophie; Nakalema, Shamirah; Matovu, Fred; Ssemata, Andrew Sentoogo; Alezuyo, Connie; Neema, Stella; Jerrim, John; Bonell, Chris; Seeley, Janet; Weiss, Helen A; MENISCUS Group

Practical guidance for running late-phase platform protocols for clinical trials: lessons from experienced UK clinical trials units. (2022) Love, Sharon B; Cafferty, Fay; Snowdon, Claire; Carty, Karen; Savage, Joshua; Pallmann, Philip; McParland, Lucy; Brown, Louise; Masters, Lindsey; Schiavone, Francesca; Hague, Dominic; Townsend, Stephen; Amos, Claire; South, Annabelle; Sturgeon, Kate; Langley, Ruth; Maughan, Timothy; James, Nicholas; Hall, Emma; Kernaghan, Sarah; Bliss, Judith; Turner, Nick; Tutt, Andrew; Yap, Christina; Firth, Charlotte; Kong, Anthony; Mehanna, Hisham; Watts, Colin; Hills, Robert; Thomas, Ian; Copland, Mhairi; Bell, Sue; Sebag-Montefiore, David; Jones, Robert; Parmar, Mahesh KB; Sydes, Matthew R

A cluster-randomised, non-inferiority trial of the impact of a two-dose compared to three-dose schedule of pneumococcal conjugate vaccination in rural Gambia: the PVS trial. (2022) Mackenzie, Grant A; Osei, Isaac; Salaudeen, Rasheed; Hossain, Ilias; Young, Benjamin; Secka, Ousman; D'Alessandro, Umberto; Palmu, Arto A; Jokinen, Jukka; Hinds, Jason; Flasche, Stefan; Mulholland, Kim; Nguyen, Cattram; Greenwood, Brian

Pneumococcal vaccine schedules (PVS) study: a cluster-randomised, non-inferiority trial of an alternative versus standard schedule for pneumococcal conjugate vaccination-statistical analysis plan. (2022) Mackenzie, Grant A; Palmu, Arto A; Jokinen, Jukka; Osei, Isaac; Flasche, Stefan; Greenwood, Brian; Mulholland, Kim; Nguyen, Cattram

WILL (When to Induce Labour to Limit risk in pregnancy hypertension): a multicentre randomised controlled trial - adaptations to deliver a timing-of-birth trial during the COVID-19 international pandemic. (2022) Magee, Laura A; Tohill, Sue; Kirkham, Katie; Evans, Ruth; Gkini, Eleni; Moakes, Catherine A; Stubbs, Clive; Thornton, Jim; von Dadelszen, Peter; WILL Trial Study Group

Reducing HIV-related stigma among young people attending school in Northern Uganda: study protocol for a participatory arts-based population health intervention and stepped-wedge cluster-randomized trial. (2022) Mendelsohn, Joshua B; Fournier, Bonnie; Caron-Roy, Stéphanie; Maina, Geoffrey; Strudwick, Gillian; Ojok, Santo; Lim, Hyun June; Sanches, Marcos; Logie, Carmen H; Sommerfeldt, Susan; Nykiforuk, Candace; Harrowing, Jean; Adyanga, Francis Akena; Hakiigaba, Jussy Okello; Bilash, Olenka

Planning a method for covariate adjustment in individually randomised trials: a practical guide. (2022) Morris, Tim P; Walker, A Sarah; Williamson, Elizabeth J; White, Ian R

Correction: Assessing the impact of a novel house design on the incidence of malaria in children in rural Africa: study protocol for a household-cluster randomized controlled superiority trial. (2022) Mshamu, Salum; Mmbando, Arnold; Meta, Judith; Bradley, John; Bøjstrup, Thomas Chevalier; Day, Nicholas PJ; Mukaka, Mavuto; Okumu, Fredros; Olotu, Ally; Pell, Christopher; Deen, Jacqueline; Knudsen, Jakob; Lindsay, Steven W; von Seidlein, Lorenz

Rifapentine and isoniazid for prevention of tuberculosis in people with diabetes (PROTID): protocol for a randomised controlled trial. (2022) Ntinginya, Nyanda Elias; Te Brake, Lindsey; Sabi, Issa; Chamba, Nyasatu; Kilonzo, Kajiru; Laizer, Sweetness; Andia-Biraro, Irene; Kibirige, Davis; Kyazze, Andrew Peter; Ninsiima, Sandra; Critchley, Julia A; Romeo, Renee; van de Maat, Josephine; Olomi, Willyhelmina; Mrema, Lucy; Magombola, David; Mwayula, Issakwisa Habakkuk; Sharples, Katrina; Hill, Philip C; van Crevel, Reinout; PROTID Consortium

Insecticide-treated eave nets and window screens for malaria control in Chalinze district, Tanzania: a study protocol for a household randomised control trial. (2022) Odufuwa, Olukayode G; Moore, Sarah Jane; Mboma, Zawadi Mageni; Mbuba, Emmanuel; Muganga, Joseph Barnabas; Moore, Jason; Philipo, Rose; Rashid, Mohammed Ally; Bosselmann, Rune; Skovmand, Ole; Bradley, John

The Positive Choices trial: update to study protocol for a phase-III RCT trial of a whole-school social-marketing intervention to promote sexual health and reduce health inequalities. (2022) Ponsford, Ruth; Meiksin, Rebecca; Allen, Elizabeth; Melendez-Torres, GJ; Morris, Steve; Mercer, Catherine; Campbell, Rona; Young, Honor; Lohan, Maria; Coyle, Karin; Bonell, Chris

Comprehensive Anaemia Programme and Personalized Therapies (CAPPT): protocol for a cluster-randomised controlled trial testing the effect women's groups, home counselling and iron supplementation on haemoglobin in pregnancy in southern Nepal. (2022) Saville, Naomi M; Kharel, Chandani; Morrison, Joanna; Harris-Fry, Helen; James, Philip; Copas, Andrew; Giri, Santosh; Arjyal, Abriti; Beard, B James; Haghparast-Bidgoli, Hassan; Skordis, Jolene; Richter, Adam; Baral, Sushil; Hillman, Sara

A quasi-randomised controlled trial of online distribution of home-based hepatitis C self-testing for key populations in Malaysia: a study protocol. (2022) Shilton, Sonjelle; Sem, Xiaohui; Chan, Huan-Keat; Chung, Han Yang; Karunanithy, Anu; Markby, Jessica; Chan, Po-Lin; Luhmann, Niklas; Johnson, Cheryl; Nabeta, Pamela; Nasir, Nazrila Hairizan Bt; Ongarello, Stefano; Reipold, Elena Ivanova; Hassan, Muhammad Radzi Abu

Are realist randomised controlled trials possible? A reflection on the INCLUSIVE evaluation of a whole-school, bullying-prevention intervention. (2022) Warren, Emily A; Melendez-Torres, GJ; Bonell, Chris

A cost-effectiveness and value of information analysis to inform future research of tranexamic acid for older adults experiencing mild traumatic brain injury. (2022) Williams, Jack; Ker, Katharine; Roberts, Ian; Shakur-Still, Haleema; Miners, Alec

A cost-effectiveness and value of information analysis to inform future research of tranexamic acid for older adults experiencing mild traumatic brain injury. (2022) Williams, Jack; Ker, Katharine; Roberts, Ian; Shakur-Still, Haleema; Miners, Alec

2021

Correction to: Partnership for Research on Ebola VACcination (PREVAC): protocol of a randomized, double-blind, placebo-controlled phase 2 clinical trial evaluating three vaccine strategies against Ebola in healthy volunteers in four West African countries. (2021) Badio, Moses; Lhomme, Edouard; Kieh, Mark; Beavogui, Abdoul Habib; Kennedy, Stephen B; Doumbia, Seydou; Leigh, Bailah; Sow, Samba O; Diallo, Alpha; Fusco, Daniela; Kirchoff, Matthew; Termote, Monique; Vatrinet, Renaud; Wentworth, Deborah; Esperou, Helène; Lane, H Clifford; Pierson, Jerome; Watson-Jones, Deborah; Roy, Céline; D'Ortenzio, Eric; Greenwood, Brian; Chêne, Genevieve; Richer, Laura; Neaton, James D; Yazdanpanah, Yazdan; PREVAC study team

Partnership for Research on Ebola VACcination (PREVAC): protocol of a randomized, double-blind, placebo-controlled phase 2 clinical trial evaluating three vaccine strategies against Ebola in healthy volunteers in four West African countries. (2021) Badio, Moses; Lhomme, Edouard; Kieh, Mark; Beavogui, Abdoul Habib; Kennedy, Stephen B; Doumbia, Seydou; Leigh, Bailah; Sow, Samba O; Diallo, Alpha; Fusco, Daniela; Kirchoff, Matthew; Termote, Monique; Vatrinet, Renaud; Wentworth, Deborah; Esperou, Helène; Lane, H Clifford; Pierson, Jerome; Watson-Jones, Deborah; Roy, Céline; D'Ortenzio, Eric; Greenwood, Brian; Chêne, Genevieve; Richert, Laura; Neaton, James D; Yazdanpanah, Yazdan; PREVAC study team

How 'place' matters for addressing the HIV epidemic: evidence from the HPTN 071 (PopART) cluster-randomised controlled trial in Zambia and South Africa. (2021) Bond, Virginia; Hoddinott, Graeme; Viljoen, Lario; Ngwenya, Fredrick; Simuyaba, Melvin; Chiti, Bwalya; Ndubani, Rhoda; Makola, Nozizwe; Donnell, Deborah; Schaap, Ab; Floyd, Sian; Hargreaves, James; Shanaube, Kwame; Fidler, Sarah; Bock, Peter; Ayles, Helen; Hayes, Richard; Simwinga, Musonda; Seeley, Janet; HPTN071 (PopART) study team

Trends in clinical trial registration in sub-Saharan Africa between 2010 and 2020: a cross-sectional review of three clinical trial registries. (2021) Edem, Bassey; Onwuchekwa, Chukwuemeka; Wariri, Oghenebrume; Nkereuwem, Esin; Nkereuwem, Oluwatosin O; Williams, Victor

Including random centre effects in design, analysis and presentation of multi-centre trials. (2021) Edgar, Kate; Roberts, Ian; Sharples, Linda

Recruiting for research on sensitive topics in schools: an experience with Vaxcards, a collectable vaccine card game. (2021) Epstein, DS; Enticott, JC; Larson, HJ; Barton, C

A cluster randomized controlled trial for assessing POC-CCA test based praziquantel treatment for schistosomiasis control in pregnant women and their young children: study protocol of the freeBILy clinical trial in Madagascar. (2021) Fusco, Daniela; Rakotozandrindrainy, Raphäel; Rakotoarivelo, Rivo Andry; Andrianarivelo, Mala Rakoto; Rakotozandrindrainy, Njary; Rasamoelina, Tahinamandranto; Puradiredja, Dewi Ismajani; Klein, Philipp; Stahlberg, Karl; Dechenaud, Marie; Lorenz, Eva; Jaeger, Anna; Kreidenweiss, Andrea; Hoekstra, Pytsje T; Adegnika, Akim Ayola; Sicuri, Elisa; Corstjens, Paul LAM; van Dam, Govert J; May, Jürgen; Schwarz, Norbert Georg; freeBILy consortium

The impact of improved water supply on cholera and diarrhoeal diseases in Uvira, Democratic Republic of the Congo: a protocol for a pragmatic stepped-wedge cluster randomised trial and economic evaluation. (2021) Gallandat, Karin; Jeandron, Aurélie; Ross, Ian; Mufitini Saidi, Jaime; Bashige Rumedeka, Baron; Lumami Kapepula, Vercus; Cousens, Simon; Allen, Elizabeth; MacDougall, Amy; Cumming, Oliver

The Early Youth Engagement in first episode psychosis (EYE-2) study: pragmatic cluster randomised controlled trial of implementation, effectiveness and cost-effectiveness of a team-based motivational engagement intervention to improve engagement. (2021) Greenwood, Kathryn; Webb, Rebecca; Gu, Jenny; Fowler, David; de Visser, Richard; Bremner, Stephen; Abramowicz, Iga; Perry, Nicky; Clark, Stuart; O'Donnell, Anastacia; Charlton, Dan; Jarvis, Rebecca; Garety, Philippa; Nandha, Sunil; Lennox, Belinda; Johns, Louise; Rathod, Shanaya; Phiri, Peter; French, Paul; Law, Heather; Hodgekins, Jo; Painter, Michelle; Treise, Cate; Plaistow, James; Irwin, Francis; Thompson, Rose; Mackay, Tanya; May, Carl R; Healey, Andy; Hooper, Richard; Peters, Emmanuelle

A comparison of different community models of antiretroviral therapy delivery with the standard of care among stable HIV+ patients: rationale and design of a non-inferiority cluster randomized trial, nested in the HPTN 071 (PopART) study. (2021) Limbada, Mohammed; Bwalya, Chiti; Macleod, David; Floyd, Sian; Schaap, Ab; Situmbeko, Vasty; Hayes, Richard; Fidler, Sarah; Ayles, Helen; HPTN 071 (PopART) Study Team

Effect of a nurse-led lifestyle choice and coaching intervention on systolic blood pressure among type 2 diabetic patients with a high atherosclerotic cardiovascular risk: study protocol for a cluster-randomized trial. (2021) Lumu, William; Kibirige, Davis; Wesonga, Ronald; Bahendeka, Silver

Accessing routinely collected health data to improve clinical trials: recent experience of access. (2021) Macnair, Archie; Love, Sharon B; Murray, Macey L; Gilbert, Duncan C; Parmar, Mahesh KB; Denwood, Tom; Carpenter, James; Sydes, Matthew R; Langley, Ruth E; Cafferty, Fay H

Educational films for improving screening and self-management of gestational diabetes in India and Uganda (GUIDES): study protocol for a cluster-randomised controlled trial. (2021) Oakley, Laura L; R, Deepa; Namara, Arthur; Sahu, Biswamitra; Nadal, Iliatha Papachristou; Ana, Yamuna; Coombe, Helen; Oteng-Ntim, Eugene; Seeley, Janet; Nyirenda, Moffat; Babu, Giridhar; Kinra, Sanjay

The Positive Choices trial: study protocol for a Phase-III RCT trial of a whole-school social marketing intervention to promote sexual health and reduce health inequalities. (2021) Ponsford, Ruth; Meiksin, Rebecca; Allen, Elizabeth; Melendez-Torres, GJ; Morris, Steve; Mercer, Catherine; Campbell, Rona; Young, Honor; Lohan, Maria; Coyle, Karin; Bonell, Chris

Missing clinical trial data: the evidence gap in primary data for potential COVID-19 drugs. (2021) Rodgers, Florence; Pepperrell, Toby; Keestra, Sarai; Pilkington, Victoria

Measuring the effectiveness of integrated vector management with targeted outdoor residual spraying and autodissemination devices on the incidence of dengue in urban Malaysia in the iDEM trial (intervention for Dengue Epidemiology in Malaysia): study protocol for a cluster randomized controlled trial. (2021) Saadatian-Elahi, Mitra; Alexander, Neal; Möhlmann, Tim; Langlois-Jacques, Carole; Suer, Remco; Ahmad, Nazni Wasi; Mudin, Rose Nani; Ariffin, Farah Diana; Baur, Frederic; Schmitt, Frederic; Richardson, Jason H; Rabilloud, Muriel; Hamid, Nurulhusna Ab

Effectiveness of low-dose theophylline for the management of biomass-associated COPD (LODOT-BCOPD): study protocol for a randomized controlled trial. (2021) Siddharthan, Trishul; Pollard, Suzanne L; Jackson, Peter; Robertson, Nicole M; Wosu, Adaeze C; Rahman, Nihaal; Padalkar, Roma; Sekitoleko, Isaac; Namazzi, Esther; Alupo, Patricia; Hurst, John R; Kalyesubula, Robert; Dowdy, David; Wise, Robert; Barnes, Peter J; Checkley, William; Kirenga, Bruce

A framework for handling missing accelerometer outcome data in trials. (2021) Tackney, Mia S; Cook, Derek G; Stahl, Daniel; Ismail, Khalida; Williamson, Elizabeth; Carpenter, James

The praziquantel in preschoolers (PIP) trial: study protocol for a phase II PK/PD-driven randomised controlled trial of praziquantel in children under 4 years of age. (2021) Webb, Emily L; Edielu, Andrew; Wu, Hannah W; Kabatereine, Narcis B; Tukahebwa, Edridah M; Mubangizi, Alfred; Adriko, Moses; Elliott, Alison M; Hope, William W; Mawa, Patrice A; Friedman, Jennifer F; Bustinduy, Amaya L

2020

Protocol for a cluster randomised trial in Madhya Pradesh, India: community health promotion and medical provision and impact on neonates (CHAMPION2); and support to rural India's public education system and impact on numeracy and literacy scores (STRIPES2). (2020) Agarwal, Arjun; Banerji, Rukmini; Boone, Peter; Elbourne, Diana; Fazzio, Ila; Frost, Chris; Gopal, Madan; Karnati, Sridevi; Nair, Rakhi; Reddy, Harshavardhan; Reddy, Padmanabh; Sharma, Dropti; Shekhawat, Sajjan Singh; Shivalli, Siddharudha

Update to the AWED (Applying Wolbachia to Eliminate Dengue) trial study protocol: a cluster randomised controlled trial in Yogyakarta, Indonesia. (2020) Anders, Katherine L; Indriani, Citra; Ahmad, Riris Andono; Tantowijoyo, Warsito; Arguni, Eggi; Andari, Bekti; Jewell, Nicholas P; Dufault, Suzanne M; Ryan, Peter A; Tanamas, Stephanie K; Rancès, Edwige; O'Neill, Scott L; Simmons, Cameron P; Utarini, Adi

Protocol for a randomised trial of early kangaroo mother care compared to standard care on survival of pre-stabilised preterm neonates in The Gambia (eKMC). (2020) Brotherton, Helen; Gai, Abdou; Tann, Cally J; Samateh, Ahmadou Lamin; Seale, Anna C; Zaman, Syed MA; Cousens, Simon; Roca, Anna; Lawn, Joy E

When assessing generalisability, focusing on differences in population or setting alone is insufficient. (2020) Burchett, Helen ED; Kneale, Dylan; Blanchard, Laurence; Thomas, James

Tailored, psychological intervention for anxiety and/or depression in people with chronic obstructive pulmonary disease (COPD), TANDEM (Tailored intervention for ANxiety and DEpression Management in COPD): statistical analysis plan for a randomised controlled trial. (2020) Chan, Claire L; Smuk, Melanie; Sohanpal, Ratna; Pinnock, Hilary; Taylor, Stephanie JC; TANDEM Investigators

The HOME Study: Statistical and economic analysis plan for a randomised controlled trial comparing the addition of Proactive Psychological Medicine to usual care, with usual care alone, on the  time spent in hospital by older acute hospital inpatients. (2020) Magill, Nicholas; White, Ian R; Walker, Jane; Burke, Katy; Toynbee, Mark; van Niekerk, Maike; Yang, Fan; Walker, Simon; Sculpher, Mark; Sharpe, Michael; Frost, Chris

Accuracy of time to treatment estimates in the CRASH-3 clinical trial: impact on the trial results. (2020) Mansukhani, Raoul; Frimley, Lauren; Shakur-Still, Haleema; Sharples, Linda; Roberts, Ian

Operationalising kangaroo Mother care before stabilisation amongst low birth Weight Neonates in Africa (OMWaNA): protocol for a randomised controlled trial to examine mortality impact in Uganda. (2020) Medvedev, Melissa M; Tumukunde, Victor; Mambule, Ivan; Tann, Cally J; Waiswa, Peter; Canter, Ruth R; Hansen, Christian H; Ekirapa-Kiracho, Elizabeth; Katumba, Kenneth; Pitt, Catherine; Greco, Giulia; Brotherton, Helen; Elbourne, Diana; Seeley, Janet; Nyirenda, Moffat; Allen, Elizabeth; Lawn, Joy E

Safety and efficacy of belimumab after B cell depletion therapy in systemic LUPUS erythematosus (BEAT-LUPUS) trial: statistical analysis plan. (2020) Muller, Patrick; Chowdhury, Kashfia; Gordon, Caroline; Ehrenstein, Michael R; Doré, Caroline J

A randomised, multi-centre trial of total ankle replacement versus ankle arthrodesis in the treatment of patients with end stage ankle osteoarthritis (TARVA): statistical analysis plan. (2020) Muller, Patrick; Skene, Simon S; Chowdhury, Kashfia; Cro, Suzie; Goldberg, Andrew J; Doré, Caroline J; TARVA Study Group

Combined HIV Adolescent Prevention Study (CHAPS): comparison of HIV pre-exposure prophylaxis regimens for adolescents in sub-Saharan Africa-study protocol for a mixed-methods study including a randomised controlled trial. (2020) Nash, S; Dietrich, J; Ssemata, AS; Herrera, C; O'Hagan, K; Else, L; Chiodi, F; Kelly, C; Shattock, R; Chirenje, M; Lebina, L; Khoo, S; Bekker, L-G; Weiss, HA; Gray, C; Stranix-Chibanda, L; Kaleebu, P; Seeley, J; Martinson, N; Fox, J; CHAPS team

Serial prophylactic exchange blood transfusion in pregnant women with sickle cell disease (TAPS-2): study protocol for a randomised controlled feasibility trial. (2020) Oakley, Laura L; Awogbade, Moji; Brien, Sarah; Briley, Annette; Chorozoglou, Maria; Drasar, Emma; Johns, Jemma; Rhodes, Elizabeth; Robinson, Vicky; Seed, Paul; Sharif, Joseph; Singh, Claire; Telfer, Paul; Thompson, Hilary; Watt-Coote, Ingrid; Howard, Jo; Oteng-Ntim, Eugene

Optimizing the efficiency and implementation of cash transfers to improve adherence to antiretroviral therapy: study protocol for a cluster randomized controlled trial. (2020) Packel, Laura; Njau, Prosper; Fahey, Carolyn; Ramadhani, Angela; Dow, William H; Jewell, Nicholas P; McCoy, Sandra

Digital crowdsourced intervention to promote HIV testing among MSM in China: study protocol for a cluster randomized controlled trial. (2020) Ren, Ci; Tucker, Joseph D; Tang, Weiming; Tao, Xiaorun; Liao, Meizhen; Wang, Guoyong; Jiao, Kedi; Xu, Zece; Zhao, Zhe; Yan, Yu; Lin, Yuxi; Li, Chuanxi; Wang, Lin; Li, Yijun; Kang, Dianmin; Ma, Wei

Impact of a package of diagnostic tools, clinical algorithm, and training and communication on outpatient acute fever case management in low- and middle-income countries: protocol for a randomized controlled trial. (2020) Salami, Olawale; Horgan, Philip; Moore, Catrin E; Giri, Abhishek; Sserwanga, Asadu; Pathak, Ashish; Basnyat, Buddha; Kiemde, Francois; Smithuis, Frank; Kitutu, Freddy; Phutke, Gajanan; Tinto, Halidou; Hopkins, Heidi; Kapisi, James; Swe, Myo Maung Maung; Taneja, Neelam; Baiden, Rita; Dutta, Shanta; Compaore, Adelaide; Kaawa-Mafigiri, David; Hussein, Rashida; Shakya, Summita Udas; Kukula, Vida; Ongarello, Stefano; Tomar, Anjana; Chadha, Sarabjit S; Walia, Kamini; Kelly-Cirino, Cassandra; Olliaro, Piero

Tailored, psychological intervention for anxiety or depression in people with chronic obstructive pulmonary disease (COPD), TANDEM (Tailored intervention for ANxiety and DEpression Management in COPD): protocol for a randomised controlled trial. (2020) Sohanpal, Ratna; Pinnock, Hilary; Steed, Liz; Heslop Marshall, Karen; Chan, Claire; Kelly, Moira; Priebe, Stefan; Roberts, C Michael; Singh, Sally; Smuk, Melanie; Saqi-Waseem, Sarah; Healey, Andy; Underwood, Martin; White, Patrick; Warburton, Chris; Taylor, Stephanie JC; TANDEM Investigators

Effect of community active case-finding strategies for detection of tuberculosis in Cambodia: study protocol for a pragmatic cluster randomized controlled trial. (2020) Teo, Alvin Kuo Jing; Prem, Kiesha; Evdokimov, Konstantin; Ork, Chetra; Eng, Sothearith; Tuot, Sovannary; Chry, Monyrath; Mao, Tan Eang; Hsu, Li Yang; Yi, Siyan

Protocol for a randomized controlled trial: peer-to-peer Group Problem Management Plus (PM+) for adult Syrian refugees in Turkey. (2020) Uygun, Ersin; Ilkkursun, Zeynep; Sijbrandij, Marit; Aker, A Tamer; Bryant, Richard; Cuijpers, Pim; Fuhr, Daniela C; de Graaff, Anne M; de Jong, Joop; McDaid, David; Morina, Naser; Park, A-La; Roberts, Bayard; Ventevogel, Peter; Yurtbakan, Taylan; Acarturk, Ceren; STRENGHTS consortium

Using qualitative research to explore intervention mechanisms: findings from the trial of the Learning Together whole-school health intervention. (2020) Warren, Emily; Melendez-Torres, GJ; Viner, Russell; Bonell, Chris

2019

Trial management: we need a cadre of high-class triallists to deliver the answers that patients need. (2019) Beaumont, Danielle; Arribas, Monica; Frimley, Lauren; Balogun, Eni; Roberts, Ian; Shakur-Still, Haleema

Expert panel process to optimise the design of a randomised controlled trial in chronic rhinosinusitis (the MACRO programme). (2019) Blackshaw, Helen; Vennik, Jane; Philpott, Carl; Thomas, Mike; Eyles, Caroline; Carpenter, James; Clarke, Caroline S; Morris, Steve; Schilder, Anne; Lund, Valerie; Little, Paul; Durham, Stephen; Denaxas, Spiros; Williamson, Elizabeth; Beard, David; Cook, Jonathan; Le Conte, Steffi; Airey, Kim; Boardman, Jim; Hopkins, Claire

Tranexamic acid for acute gastrointestinal bleeding (the HALT-IT trial): statistical analysis plan for an international, randomised, double-blind, placebo-controlled trial. (2019) Brenner, Amy; Afolabi, Adefemi; Ahmad, Syed Masroor; Arribas, Monica; Chaudhri, Rizwana; Coats, Timothy; Cuzick, Jack; Gilmore, Ian; Hawkey, Christopher; Jairath, Vipul; Javaid, Kiran; Kayani, Aasia; Mutti, Muttiullah; Nadeem, Muhammad Arif; Shakur-Still, Haleema; Stanworth, Simon; Veitch, Andrew; Roberts, Ian; HALT-IT Trial Collaborators

Addressing challenges in tuberculosis adherence via performance-based payments for integrated case management: protocol for a cluster randomized controlled trial in Georgia. (2019) Chikovani, Ivdity; Diaconu, Karin; Duric, Predrag; Sulaberidze, Lela; Uchaneishvili, Maia; Mohammed, Nuredin Ibrahim; Zoidze, Akaki; Witter, Sophie

Beyond interviews and focus groups: a framework for integrating innovative qualitative methods into randomised controlled trials of complex public health interventions. (2019) Davis, Katy; Minckas, Nicole; Bond, Virginia; Clark, Cari Jo; Colbourn, Tim; Drabble, Sarah J; Hesketh, Therese; Hill, Zelee; Morrison, Joanna; Mweemba, Oliver; Osrin, David; Prost, Audrey; Seeley, Janet; Shahmanesh, Maryam; Spindler, Esther J; Stern, Erin; Turner, Katrina M; Mannell, Jenevieve

Reducing research waste by promoting informed responses to invitations to participate in clinical trials. (2019) Elbourne, Diana

Reducing research waste by promoting informed responses to invitations to participate in clinical trials. (2019) Gillies, Katie; Chalmers, Iain; Glasziou, Paul; Elbourne, Diana; Elliott, Jim; Treweek, Shaun

COMPare: Qualitative analysis of researchers' responses to critical correspondence on a cohort of 58 misreported trials. (2019) Goldacre, Ben; Drysdale, Henry; Marston, Cicely; Mahtani, Kamal R; Dale, Aaron; Milosevic, Ioan; Slade, Eirion; Hartley, Philip; Heneghan, Carl

How context can impact clinical trials: a multi-country qualitative case study comparison of diagnostic biomarker test interventions. (2019) Haenssgen, Marco J; Charoenboon, Nutcha; Do, Nga TT; Althaus, Thomas; Khine Zaw, Yuzana; Wertheim, Heiman FL; Lubell, Yoel

Protocol for the cost-consequence and equity impact analyses of a cluster randomised controlled trial comparing three variants of a nutrition-sensitive agricultural extension intervention to improve maternal and child dietary diversity and nutritional status in rural Odisha, India (UPAVAN trial). (2019) Haghparast-Bidgoli, Hassan; Skordis, Jolene; Harris-Fry, Helen; Krishnan, Sneha; O'Hearn, Meghan; Kumar, Abhinav; Pradhan, Ronali; Mishra, Naba Kishore; Upadhyay, Avinash; Pradhan, Shibananth; Ojha, Amit Kumar; Cunningham, Sarah; Rath, Shibanand; Palmer, Tom; Koniz-Booher, Peggy; Kadiyala, Suneetha

Changing platforms without stopping the train: experiences of data management and data management systems when adapting platform protocols by adding and closing comparisons. (2019) Hague, Dominic; Townsend, Stephen; Masters, Lindsey; Rauchenberger, Mary; Van Looy, Nadine; Diaz-Montana, Carlos; Gannon, Melissa; James, Nicholas; Maughan, Tim; Parmar, Mahesh KB; Brown, Louise; Sydes, Matthew R; STAMPEDE and FOCUS4 investigators

Prevention of Morbidity in Sickle Cell Disease (POMS2a)-overnight auto-adjusting continuous positive airway pressure compared with nocturnal oxygen therapy: a randomised crossover pilot study examining patient preference and safety in adults and children. (2019) Howard, Jo; Lee, Sophie A; Inusa, Baba; Cheng, Man Ying Edith; Bavenjit, Cheema; Reading, Isabel C; Wakeford, Sally Ann; Gavlak, Johanna C; Murphy, Patrick B; Hart, Nicholas; Gupta, Atul; Sahota, Sati; Jacob, Eufemia; Chorozoglou, Maria; Ossai, Carol; Gwam, Maureen; Kirkham, Fenella J; Wade, Angela M; Liossi, Christina

Can selenium deficiency in Malawi be alleviated through consumption of agro-biofortified maize flour? Study protocol for a randomised, double-blind, controlled trial. (2019) Joy, Edward JM; Kalimbira, Alexander A; Gashu, Dawd; Ferguson, Elaine L; Sturgess, Joanna; Dangour, Alan D; Banda, Leonard; Chiutsi-Phiri, Gabriella; Bailey, Elizabeth H; Langley-Evans, Simon C; Lark, R Murray; Millar, Kate; Young, Scott D; Matandika, Limbanazo; Mfutso-Bengo, Joseph; Phuka, John C; Phiri, Felix P; Gondwe, Jellita; Ander, E Louise; Lowe, Nicola M; Nalivata, Patson C; Broadley, Martin R; Allen, Elizabeth

Can selenium deficiency in Malawi be alleviated through consumption of agro-biofortified maize flour? Study protocol for a randomised, double-blind, controlled trial. (2019) Joy, Edward; Kalimbira, Alexander; Gashu, Dawd; Ferguson, Elaine; Sturgess, Joanna; Dangour, Alan; Banda, Leonard; Chiutsi-Phiri, Gabriella; Bailey, Elizabeth; Langley-Evans, Simon; Lark, Murray; Millar, Kate; Young, Scott; Matandika, Limbanazo; Mfutso-Bengo, Joseph; Phuka, John; Phiri, Felix; Gondwe, Jellita; Ander, Louise; Lowe, Nicola; Nalivata, Patson; Broadley, Martin; Allen, Elizabeth

Study protocol for a peer-led web-based intervention to promote safe usage of dating applications among young adults: a cluster randomized controlled trial. (2019) Lau, Stephanie Tsz Hei; Choi, Kitty Wai Ying; Chen, Julie; Mak, William Pak-Hing; Yeung, Ho Kong Christopher Au; Tucker, Joseph; Wong, William Chi-Wai

A randomized controlled trial of an intervention delivered by mobile phone text message to increase the acceptability of effective contraception among young women in Palestine. (2019) McCarthy, Ona L; Zghayyer, Hanadi; Stavridis, Amina; Adada, Samia; Ahamed, Irrfan; Leurent, Baptiste; Edwards, Phil; Palmer, Melissa; Free, Caroline

The effectiveness of a low-intensity problem-solving intervention for common adolescent mental health problems in New Delhi, India: protocol for a school-based, individually randomized controlled trial with an embedded stepped-wedge, cluster randomized controlled recruitment trial. (2019) Parikh, Rachana; Michelson, Daniel; Malik, Kanika; Shinde, Sachin; Weiss, Helen A; Hoogendoorn, Adriaan; Ruwaard, Jeroen; Krishna, Madhuri; Sharma, Rhea; Bhat, Bhargav; Sahu, Rooplata; Mathur, Sonal; Sudhir, Paulomi; King, Michael; Cuijpers, Pim; Chorpita, Bruce F; Fairburn, Christopher G; Patel, Vikram

Peek Community Eye Health - mHealth system to increase access and efficiency of eye health services in Trans Nzoia County, Kenya: study protocol for a cluster randomised controlled trial. (2019) Rono, Hillary; Bastawrous, Andrew; Macleod, David; Wanjala, Emmanuel; Gichuhi, Stephen; Burton, Matthew

LLIN Evaluation in Uganda Project (LLINEUP) - Impact of long-lasting insecticidal nets with, and without, piperonyl butoxide on malaria indicators in Uganda: study protocol for a cluster-randomised trial. (2019) Staedke, Sarah G; Kamya, Moses R; Dorsey, Grant; Maiteki-Sebuguzi, Catherine; Gonahasa, Samuel; Yeka, Adoke; Lynd, Amy; Opigo, Jimmy; Hemingway, Janet; Donnelly, Martin J

Using discrete choice experiments to inform the design of complex interventions. (2019) Terris-Prestholt, Fern; Neke, Nyasule; Grund, Jonathan M; Plotkin, Marya; Kuringe, Evodius; Osaki, Haika; Ong, Jason J; Tucker, Joseph D; Mshana, Gerry; Mahler, Hally; Weiss, Helen A; Wambura, Mwita; VMMC study team

The HOME Study: study protocol for a randomised controlled trial comparing the addition of Proactive Psychological Medicine to usual care, with usual care alone, on the time spent in hospital by older acute hospital inpatients. (2019) Walker, Jane; Burke, Katy; Toynbee, Mark; van Niekerk, Maike; Frost, Chris; Magill, Nicholas; Walker, Simon; Sculpher, Mark; White, Ian R; Sharpe, Michael

2018

The AWED trial (Applying Wolbachia to Eliminate Dengue) to assess the efficacy of Wolbachia-infected mosquito deployments to reduce dengue incidence in Yogyakarta, Indonesia: study protocol for a cluster randomised controlled trial. (2018) Anders, Katherine L; Indriani, Citra; Ahmad, Riris Andono; Tantowijoyo, Warsito; Arguni, Eggi; Andari, Bekti; Jewell, Nicholas P; Rances, Edwige; O'Neill, Scott L; Simmons, Cameron P; Utarini, Adi

Combined Protocol for Acute Malnutrition Study (ComPAS) in rural South Sudan and urban Kenya: study protocol for a randomized controlled trial. (2018) Bailey, Jeanette; Lelijveld, Natasha; Marron, Bethany; Onyoo, Pamela; Ho, Lara S; Manary, Mark; Briend, André; Opondo, Charles; Kerac, Marko

Are randomised controlled trials positivist? Reviewing the social science and philosophy literature to assess positivist tendencies of trials of social interventions in public health and health services. (2018) Bonell, Chris; Moore, Graham; Warren, Emily; Moore, Laurence

Outcome measures in clinical trials of treatments for acute severe haemorrhage. (2018) Brenner, Amy; Arribas, Monica; Cuzick, Jack; Jairath, Vipul; Stanworth, Simon; Ker, Katharine; Shakur-Still, Haleema; Roberts, Ian

Application of causal inference methods in the analyses of randomised controlled trials: a systematic review. (2018) Farmer, Ruth E; Kounali, Daphne; Walker, A Sarah; Savović, Jelena; Richards, Alison; May, Margaret T; Ford, Deborah

Upscaling Participatory Action and Videos for Agriculture and Nutrition (UPAVAN) trial comparing three variants of a nutrition-sensitive agricultural extension intervention to improve maternal and child nutritional outcomes in rural Odisha, India: study protocol for a cluster randomised controlled trial. (2018) Kadiyala, Suneetha; Prost, Audrey; Harris-Fry, Helen; O'Hearn, Meghan; Pradhan, Ronali; Pradhan, Shibananth; Mishra, Naba Kishore; Rath, Suchitra; Nair, Nirmala; Rath, Shibanand; Tripathy, Prasantha; Krishnan, Sneha; Koniz-Booher, Peggy; Danton, Heather; Elbourne, Diana; Sturgess, Joanna; Beaumont, Emma; Haghparast-Bidgoli, Hassan; Skordis-Worrall, Jolene; Mohanty, Satyanarayan; Upadhay, Avinash; Allen, Elizabeth

Tranexamic acid for the prevention of postpartum bleeding in women with anaemia: study protocol for an international, randomised, double-blind, placebo-controlled trial. (2018) Ker, Katharine; Roberts, Ian; Chaudhri, Rizwana; Fawole, Bukola; Beaumont, Danielle; Balogun, Eni; Prowse, Danielle; Pepple, Tracey; Javaid, Kiran; Kayani, Aasia; Arulkumaran, Sabaratnam; Bates, Imelda; Shakur-Still, Haleema; WOMAN-2 trial collaborators

'Test n Treat (TnT)'- Rapid testing and same-day, on-site treatment to reduce rates of chlamydia in sexually active further education college students: study protocol for a cluster randomised feasibility trial. (2018) Kerry-Barnard, Sarah; Fleming, Charlotte; Reid, Fiona; Phillips, Rachel; Drennan, Vari M; Adams, Elisabeth J; Majewska, Wendy; Balendra, Anjella; Harding-Esch, Emma; Cousins, Emma; Tariq Sadiq, S; Oakeshott, Pippa

AMBIsome Therapy Induction OptimisatioN (AMBITION): High Dose AmBisome for Cryptococcal Meningitis Induction Therapy in sub-Saharan Africa: Study Protocol for a Phase 3 Randomised Controlled Non-Inferiority Trial. (2018) Lawrence, David S; Youssouf, Nabila; Molloy, Síle F; Alanio, Alexandre; Alufandika, Melanie; Boulware, David R; Boyer-Chammard, Timothée; Chen, Tao; Dromer, Francoise; Hlupeni, Admire; Hope, William; Hosseinipour, Mina C; Kanyama, Cecilia; Lortholary, Oliver; Loyse, Angela; Meya, David B; Mosepele, Mosepele; Muzoora, Conrad; Mwandumba, Henry C; Ndhlovu, Chiratidzo E; Niessen, Louis; Schutz, Charlotte; Stott, Katharine E; Wang, Duolao; Lalloo, David G; Meintjes, Graeme; Jaffar, Shabbar; Harrison, Thomas S; Jarvis, Joseph N

The "ComPAS Trial" combined treatment model for acute malnutrition: study protocol for the economic evaluation. (2018) Lelijveld, Natasha; Bailey, Jeanette; Mayberry, Amy; Trenouth, Lani; N'Diaye, Dieynaba S; Haghparast-Bidgoli, Hassan; Puett, Chloe

Evaluation of a medication monitor-based treatment strategy for drug-sensitive tuberculosis patients in China: study protocol for a cluster randomised controlled trial. (2018) Lewis, James J; Liu, Xiaoqiu; Zhang, Zhiying; Thomas, Bruce V; Vassall, Anna; Sweeney, Sedona; Caihong, Xu; Dongmei, Hu; Xue, Li; Yongxin, Gao; Huan, Shitong; Shiwen, Jiang; Fielding, Katherine L

Bias due to MEasurement Reactions In Trials to improve health (MERIT): protocol for research to develop MRC guidance. (2018) Miles, Lisa M; Elbourne, Diana; Farmer, Andrew; Gulliford, Martin; Locock, Louise; McCambridge, Jim; Sutton, Stephen; French, David P

A protocol for the process evaluation of a multi-centre randomised trial to compare the effectiveness of geriatrician-led admission avoidance hospital at home versus inpatient admission. (2018) Mäkelä, Petra; Godfrey, Mary; Cradduck-Bamford, Andrea; Ellis, Graham; Shepperd, Sasha

Traumatic injury clinical trial evaluating tranexamic acid in children (TIC-TOC): study protocol for a pilot randomized controlled trial. (2018) Nishijima, Daniel K; VanBuren, John; Hewes, Hilary A; Myers, Sage R; Stanley, Rachel M; Adelson, P David; Barnhard, Sarah E; Bobinski, Matthew; Ghetti, Simona; Holmes, James F; Roberts, Ian; Schalick, Walton O; Tran, Nam K; Tzimenatos, Leah S; Michael Dean, J; Kuppermann, Nathan; TIC-TOC Collaborators of the Pediatric Emergency Care Applied Re

Reactive community-based self-administered treatment against residual malaria transmission: study protocol for a randomized controlled trial. (2018) Okebe, Joseph; Ribera, Joan Muela; Balen, Julie; Jaiteh, Fatou; Masunaga, Yoriko; Nwakanma, Davis; Bradley, John; Yeung, Shunmay; Peeters Grietens, Koen; D'Alessandro, Umberto

Assessing dengue transmission risk and a vector control intervention using entomological and immunological indices in Thailand: study protocol for a cluster-randomized controlled trial. (2018) Overgaard, Hans J; Pientong, Chamsai; Thaewnongiew, Kesorn; Bangs, Michael J; Ekalaksananan, Tipaya; Aromseree, Sirinart; Phanitchat, Thipruethai; Phanthanawiboon, Supranee; Fustec, Benedicte; Corbel, Vincent; Cerqueira, Dominique; Alexander, Neal

WASH Benefits Bangladesh trial: system for monitoring coverage and quality in an efficacy trial. (2018) Rahman, Mahbubur; Ashraf, Sania; Unicomb, Leanne; Mainuddin, AKM; Parvez, Sarker Masud; Begum, Farzana; Das, Kishor Kumar; Naser, Abu Mohd; Hussain, Faruqe; Clasen, Thomas; Luby, Stephen P; Leontsini, Elli; Winch, Peter J

When participants get involved: reconsidering patient and public involvement in clinical trials at the MRC Clinical Trials Unit at UCL. (2018) Vale, Claire L; Cragg, William J; Cromarty, Ben; Hanley, Bec; South, Annabelle; Stephens, Richard; Sturgeon, Kate; Gafos, Mitzy

Development of a standardised set of metrics for monitoring site performance in multicentre randomised trials: a Delphi study. (2018) Whitham, Diane; Turzanski, Julie; Bradshaw, Lucy; Clarke, Mike; Culliford, Lucy; Duley, Lelia; Shaw, Lisa; Skea, Zoe; Treweek, Shaun P; Walker, Kate; Williamson, Paula R; Montgomery, Alan A; Site Performance Metrics for Multicentre Randomised Trials Colla

2017

Randomized controlled trial and economic evaluation of nurse-led group support for young mothers during pregnancy and the first year postpartum versus usual care. (2017) Barnes, Jacqueline; Stuart, Jane; Allen, Elizabeth; Petrou, Stavros; Sturgess, Joanna; Barlow, Jane; Macdonald, Geraldine; Spiby, Helen; Aistrop, Dipti; Melhuish, Edward; Kim, Sung Wook; Elbourne, Diana

Safety of tubal ligation by minilaparotomy provided by clinical officers versus assistant medical officers: study protocol for a noninferiority randomized controlled trial in Tanzanian women. (2017) Barone, Mark A; Mbuguni, Zuhura; Achola, Japhet Ominde; Cordero, Carmela; Kanama, Joseph; Muganyizi, Projestine S; Mwanga, Jamilla; Shannon, Caitlin; Tibyehabwa, Leopold

Initiating change locally in bullying and aggression through the school environment (INCLUSIVE) trial: update to cluster randomised controlled trial protocol. (2017) Bonell, Chris; Mathiot, Anne; Allen, Elizabeth; Bevilacqua, Leonardo; Christie, Deborah; Elbourne, Diana; Fletcher, Adam; Grieve, Richard; Legood, Rosa; Scott, Stephen; Warren, Emily; Wiggins, Meg; Viner, Russell M

Effectiveness of an implementation optimisation intervention aimed at increasing parent engagement in HENRY, a childhood obesity prevention programme - the Optimising Family Engagement in HENRY (OFTEN) trial: study protocol for a randomised controlled trial. (2017) Bryant, Maria; Burton, Wendy; Cundill, Bonnie; Farrin, Amanda J; Nixon, Jane; Stevens, June; Roberts, Kim; Foy, Robbie; Rutter, Harry; Hartley, Suzanne; Tubeuf, Sandy; Collinson, Michelle; Brown, Julia

The impact of maintaining serum potassium ≥3.6 mEq/L vs ≥4.5 mEq/L on the incidence of new-onset atrial fibrillation in the first 120 hours after isolated elective coronary artery bypass grafting - study protocol for a randomised feasibility trial for the proposed Tight K randomized non-inferiority trial. (2017) Campbell, Niall G; Allen, Elizabeth; Sanders, Julie; Swinson, Rebecca; Birch, Sophie; Sturgess, Joanna; Al-Subaie, Nawaf; Elbourne, Diana; Montgomery, Hugh; O'Brien, Ben

Investigating interventions to increase uptake of HIV testing and linkage into care or prevention for male partners of pregnant women in antenatal clinics in Blantyre, Malawi: study protocol for a cluster randomised trial. (2017) Choko, Augustine T; Fielding, Katherine; Stallard, Nigel; Maheswaran, Hendramoorthy; Lepine, Aurelia; Desmond, Nicola; Kumwenda, Moses K; Corbett, Elizabeth L

The INVEST project: investigating the use of evidence synthesis in the design and analysis of clinical trials. (2017) Clayton, Gemma L; Smith, Isabelle L; Higgins, Julian PT; Mihaylova, Borislava; Thorpe, Benjamin; Cicero, Robert; Lokuge, Kusal; Forman, Julia R; Tierney, Jayne F; White, Ian R; Sharples, Linda D; Jones, Hayley E

Statistical analysis plan for the 'Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage' (TICH-2) trial. (2017) Flaherty, Katie; Bath, Philip M; Dineen, Robert; Law, Zhe; Scutt, Polly; Pocock, Stuart; Sprigg, Nikola; TICH-2 investigators

The KiVa antibullying program in primary schools in Chile, with and without the digital game component: study protocol for a randomized controlled trial. (2017) Gaete, Jorge; Valenzuela, Daniela; Rojas-Barahona, Cristian; Valenzuela, Eduardo; Araya, Ricardo; Salmivalli, Christina

Improving diets and nutrition through an integrated poultry value chain and nutrition intervention (SELEVER) in Burkina Faso: study protocol for a randomized trial. (2017) Gelli, Aulo; Becquey, Elodie; Ganaba, Rasmane; Headey, Derek; Hidrobo, Melissa; Huybregts, Lieven; Verhoef, Hans; Kenfack, Romain; Zongouri, Sita; Guedenet, Hannah

Azithromycin versus placebo for the treatment of HIV-associated chronic lung disease in children and adolescents (BREATHE trial): study protocol for a randomised controlled trial. (2017) Gonzalez-Martinez, Carmen; Kranzer, Katharina; McHugh, Grace; Corbett, Elizabeth L; Mujuru, Hilda; Nicol, Mark P; Rowland-Jones, Sarah; Rehman, Andrea M; Gutteberg, Tore J; Flaegstad, Trond; Odland, Jon O; Ferrand, Rashida A; BREATHE study team

Evaluating the effect of the Helping Mothers Survive Bleeding after Birth (HMS BAB) training in Tanzania and Uganda: study protocol for a randomised controlled trial. (2017) Hanson, Claudia; Pembe, Andrea B; Alwy, Fadhlun; Atuhairwe, Susan; Leshabari, Sebalda; Morris, Jessica; Kaharuza, Frank; Marrone, Gaetano; HMS BAB study team

The added value of a mobile application of Community Case Management on referral, re-consultation and hospitalization rates of children aged under 5 years in two districts in Northern Malawi: study protocol for a pragmatic, stepped-wedge cluster-randomized controlled trial. (2017) Hardy, Victoria; O'Connor, Yvonne; Heavin, Ciara; Mastellos, Nikolaos; Tran, Tammy; O'Donoghue, John; Fitzpatrick, Annette L; Ide, Nicole; Wu, Tsung-Shu Joseph; Chirambo, Griphin Baxter; Muula, Adamson S; Nyirenda, Moffat; Carlsson, Sven; Andersson, Bo; Thompson, Matthew

Determining the efficacy of guppies and pyriproxyfen (Sumilarv® 2MR) combined with community engagement on dengue vectors in Cambodia: study protocol for a randomized controlled trial. (2017) Hustedt, John; Doum, Dyna; Keo, Vanney; Ly, Sokha; Sam, BunLeng; Chan, Vibol; Alexander, Neal; Bradley, John; Prasetyo, Didot Budi; Rachmat, Agus; Muhammad, Shafique; Lopes, Sergio; Leang, Rithea; Hii, Jeffrey

Multicomponent intervention versus usual care for management of hypertension in rural Bangladesh, Pakistan and Sri Lanka: study protocol for a cluster randomized controlled trial. (2017) Jafar, Tazeen H; Jehan, Imtiaz; de Silva, H Asita; Naheed, Aliya; Gandhi, Mihir; Assam, Pryseley; Finkelstein, Eric A; Quigley, Helena Legido; Bilger, Marcel; Khan, Aamir Hameed; Clemens, John David; Ebrahim, Shah; Turner, Elizabeth L; for COBRA-BPS Study Group; Kasturiratne, Anuradhani

A nested mechanistic sub-study into the effect of tranexamic acid versus placebo on intracranial haemorrhage and cerebral ischaemia in isolated traumatic brain injury: study protocol for a randomised controlled trial (CRASH-3 Trial Intracranial Bleeding Mechanistic Sub-Study [CRASH-3 IBMS]). (2017) Mahmood, Abda; Roberts, Ian; Shakur, Haleema

Evaluating a multi-component, community-based program to improve adherence and retention in care among adolescents living with HIV in Zimbabwe: study protocol for a cluster randomized controlled trial. (2017) Mavhu, Webster; Willis, Nicola; Mufuka, Juliet; Mangenah, Collin; Mvududu, Kudzanayi; Bernays, Sarah; Mangezi, Walter; Apollo, Tsitsi; Araya, Ricardo; Weiss, Helen A; Cowan, Frances M

An intervention delivered by text message to increase the acceptability of effective contraception among young women in Palestine: study protocol for a randomised controlled trial. (2017) McCarthy, Ona L; Wazwaz, Ola; Jado, Iman; Leurent, Baptiste; Edwards, Phil; Adada, Samia; Stavridis, Amina; Free, Caroline

Effectiveness of a novel mobile health education intervention (Peek) on spectacle wear among children in India: study protocol for a randomized controlled trial. (2017) Morjaria, Priya; Bastawrous, Andrew; Murthy, Gudlavalleti Venkata Satyanarayana; Evans, Jennifer; Gilbert, Clare

Erratum to: Effectiveness of a novel mobile health education intervention (Peek) on spectacle wear among children in India: study protocol for a randomized controlled trial. (2017) Morjaria, Priya; Bastawrous, Andrew; Murthy, Gudlavalleti Venkata Satyanarayana; Evans, Jennifer; Gilbert, Clare

Tranexamic acid in bleeding trauma patients: an exploration of benefits and harms. (2017) Roberts, Ian; Edwards, Phil; Prieto, David; Joshi, Miland; Mahmood, Abda; Ker, Katharine; Shakur, Haleema

Crowdsourcing to promote HIV testing among MSM in China: study protocol for a stepped wedge randomized controlled trial. (2017) SESH Study Group; Tucker, Joseph D

Assessing loss to follow-up in the MObile Technology for Improved Family Planning (MOTIF) randomised controlled trial. (2017) Smith, Chris; Jarvis, Christopher; Free, Caroline

The optimal design of the stepped wedge trial and a comparison to other trial designs. (2017) Thompson, JA; Fielding, K; Hargreaves, J; Copas, A

The immune response to 6-monthly versus annual standard dose inactivated trivalent influenza vaccination in older people: study protocol for a randomised clinical trial. (2017) Young, Barnaby; Sadarangani, Sapna; Yew, Haur Sen; Yung, Chee Fu; Leo, Yee Sin; Chen, Mark I-Cheng; Wilder-Smith, Annelies

2016

Family-led rehabilitation after stroke in India: the ATTEND trial, study protocol for a randomized controlled trial. (2016) Alim, Mohammed; Lindley, Richard; Felix, Cynthia; Gandhi, Dorcas Beulah Chandramathy; Verma, Shweta Jain; Tugnawat, Deepak Kumar; Syrigapu, Anuradha; Anderson, Craig Stuart; Ramamurthy, Ramaprabhu Krishnappa; Langhorne, Peter; Murthy, Gudlavalleti Venkata Satyanarayana; Shamanna, Bindiganavale Ramaswamy; Hackett, Maree Lisa; Maulik, Pallab Kumar; Harvey, Lisa Anne; Jan, Stephen; Liu, Hueiming; Walker, Marion; Forster, Anne; Pandian, Jeyaraj Durai

The quality of reporting in cluster randomised crossover trials: proposal for reporting items and an assessment of reporting quality. (2016) Arnup, Sarah J; Forbes, Andrew B; Kahan, Brennan C; Morgan, Katy E; McKenzie, Joanne E

Community-based Rehabilitation Intervention for people with Schizophrenia in Ethiopia (RISE): study protocol for a cluster randomised controlled trial. (2016) Asher, Laura; De Silva, Mary; Hanlon, Charlotte; Weiss, Helen A; Birhane, Rahel; Ejigu, Dawit A; Medhin, Girmay; Patel, Vikram; Fekadu, Abebaw

Realist trials and the testing of context-mechanism-outcome configurations: a response to Van Belle et al. (2016) Bonell, Chris; Warren, Emily; Fletcher, Adam; Viner, Russell

Perspectives on the design and methodology of periconceptional nutrient supplementation trials. (2016) Brabin, Bernard J; Gies, Sabine; Owens, Stephen; Claeys, Yves; D'Alessandro, Umberto; Tinto, Halidou; Brabin, Loretta

An analysis of baseline data from the PROUD study: an open-label randomised trial of pre-exposure prophylaxis. (2016) Dolling, David I; Desai, Monica; McOwan, Alan; Gilson, Richard; Clarke, Amanda; Fisher, Martin; Schembri, Gabriel; Sullivan, Ann K; Mackie, Nicola; Reeves, Iain; Portman, Mags; Saunders, John; Fox, Julie; Bayley, Jake; Brady, Michael; Bowman, Christine; Lacey, Charles J; Taylor, Stephen; White, David; Antonucci, Simone; Gafos, Mitzy; McCormack, Sheena; Gill, Owen N; Dunn, David T; Nardone, Anthony; PROUD Study Group

Process evaluation of a knowledge translation intervention using facilitation of local stakeholder groups to improve neonatal survival in the Quang Ninh province, Vietnam. (2016) Eriksson, Leif; Huy, Tran Q; Duc, Duong M; Ekholm Selling, Katarina; Hoa, Dinh P; Thuy, Nguyen T; Nga, Nguyen T; Persson, Lars-Åke; Wallin, Lars

Evaluation of alternative school feeding models on nutrition, education, agriculture and other social outcomes in Ghana: rationale, randomised design and baseline data. (2016) Gelli, Aulo; Masset, Edoardo; Folson, Gloria; Kusi, Anthoni; Arhinful, Daniel K; Asante, Felix; Ayi, Irene; Bosompem, Kwabena M; Watkins, Kristie; Abdul-Rahman, Lutuf; Agble, Rosanna; Ananse-Baden, Getrude; Mumuni, Daniel; Aurino, Elisabetta; Fernandes, Meena; Drake, Lesley

OpenTrials: towards a collaborative open database of all available information on all clinical trials. (2016) Goldacre, Ben; Gray, Jonathan

The role of therapeutic optimism in recruitment to a clinical trial in a peripartum setting: balancing hope and uncertainty. (2016) Hallowell, Nina; Snowdon, Claire; Morrow, Susan; Norman, Jane E; Denison, Fiona C; Lawton, Julia

Statistical design and analysis plan for an impact evaluation of an HIV treatment and prevention intervention for female sex workers in Zimbabwe: a study protocol for a cluster randomised controlled trial. (2016) Hargreaves, James R; Fearon, Elizabeth; Davey, Calum; Phillips, Andrew; Cambiano, Valentina; Cowan, Frances M

The effects of improved sanitation on diarrheal prevalence, incidence, and duration in children under five in the SNNPR State, Ethiopia: study protocol for a randomized controlled trial. (2016) Jung, Sunghoon; Doh, Young-Ah; Bizuneh, Dawit Belew; Beyene, Habtamu; Seong, Jieun; Kwon, Hyunjin; Kim, Yongwhan; Habteyes, Girma Negussie; Tefera, Yigrem; Cha, Seungman

Increased risk of type I errors in cluster randomised trials with small or medium numbers of clusters: a review, reanalysis, and simulation study. (2016) Kahan, Brennan C; Forbes, Gordon; Ali, Yunus; Jairath, Vipul; Bremner, Stephen; Harhay, Michael O; Hooper, Richard; Wright, Neil; Eldridge, Sandra M; Leyrat, Clémence

European COMPARative Effectiveness research on blended Depression treatment versus treatment-as-usual (E-COMPARED): study protocol for a randomized controlled, non-inferiority trial in eight European countries. (2016) Kleiboer, Annet; Smit, Jan; Bosmans, Judith; Ruwaard, Jeroen; Andersson, Gerhard; Topooco, Naira; Berger, Thomas; Krieger, Tobias; Botella, Cristina; Baños, Rosa; Chevreul, Karine; Araya, Ricardo; Cerga-Pashoja, Arlinda; Cieślak, Roman; Rogala, Anna; Vis, Christiaan; Draisma, Stasja; van Schaik, Anneke; Kemmeren, Lise; Ebert, David; Berking, Matthias; Funk, Burkhardt; Cuijpers, Pim; Riper, Heleen

TSCQ study: a randomized, controlled, open-label trial of daily trimethoprim-sulfamethoxazole or weekly chloroquine among adults on antiretroviral therapy in Malawi: study protocol for a randomized controlled trial. (2016) Laurens, Matthew B; Mungwira, Randy G; Nyirenda, Osward M; Divala, Titus H; Kanjala, Maxwell; Muwalo, Francis; Mkandawire, Felix A; Tsirizani, Lufina; Nyangulu, Wongani; Mwinjiwa, Edson; Taylor, Terrie E; Mallewa, Jane; Blackwelder, William C; Plowe, Christopher V; Laufer, Miriam K; van Oosterhout, Joep J

Recruiting and consenting into a peripartum trial in an emergency setting: a qualitative study of the experiences and views of women and healthcare professionals. (2016) Lawton, Julia; Snowdon, Claire; Morrow, Susan; Norman, Jane E; Denison, Fiona C; Hallowell, Nina

The impact of albendazole treatment on the incidence of viral- and bacterial-induced diarrhea in school children in southern Vietnam: study protocol for a randomized controlled trial. (2016) Leung, Jacqueline M; Hong, Chau Tran Thi; Trung, Nghia Ho Dang; Thi, Hoa Nhu; Minh, Chau Nguyen Ngoc; Thi, Thuy Vu; Hong, Dinh Thanh; Man, Dinh Nguyen Huy; Knowles, Sarah CL; Wolbers, Marcel; Hoang, Nhat Le Thanh; Thwaites, Guy; Graham, Andrea L; Baker, Stephen

Simple steps to develop trial follow-up procedures. (2016) McCarthy, Ona; French, Rebecca S; Roberts, Ian; Free, Caroline

Spectacle wearing in children randomised to ready-made or custom spectacles, and potential cost savings to programmes: study protocol for a randomised controlled trial. (2016) Morjaria, Priya; Murali, Kaushik; Evans, Jennifer; Gilbert, Clare

Assessment of learning curves in complex surgical interventions: a consecutive case-series study. (2016) Papachristofi, Olympia; Jenkins, David; Sharples, Linda D

The RooPfs study to assess whether improved housing provides additional protection against clinical malaria over current best practice in The Gambia: study protocol for a randomized controlled study and ancillary studies. (2016) Pinder, Margaret; Conteh, Lesong; Jeffries, David; Jones, Caroline; Knudsen, Jakob; Kandeh, Balla; Jawara, Musa; Sicuri, Elisa; D'Alessandro, Umberto; Lindsay, Steve W

The effect of tranexamic acid on the risk of death and hysterectomy in women with post-partum haemorrhage: statistical analysis plan for the WOMAN trial. (2016) Shakur, Haleema; Roberts, Ian; Edwards, Philip; Elbourne, Diana; Alfirevic, Zarko; Ronsmans, Carine

Erratum to: 'Models and impact of patient and public involvement in studies carried out by the Medical Research Council Clinical Trials Unit at University College London: findings from ten case studies'. (2016) South, A; Hanley, B; Gafos, M; Cromarty, B; Stephens, R; Sturgeon, K; Scott, K; Cragg, WJ; Tweed, CD; Teera, J; Vale, CL

Models and impact of patient and public involvement in studies carried out by the Medical Research Council Clinical Trials Unit at University College London: findings from ten case studies. (2016) South, Annabelle; Hanley, Bec; Gafos, Mitzy; Cromarty, Ben; Stephens, Richard; Sturgeon, Kate; Scott, Karen; Cragg, William J; Tweed, Conor D; Teera, Jacqueline; Vale, Claire L

Implications of Misspecifed Mixed Effect Models in Stepped Wedge Trial Analysis: How Wrong Can It Be? (2016) Thompson, JA; Fielding, KL; Davey, C; Aiken, AM; Hargreaves, JR; Hayes, RJ

The impact of long-lasting microbial larvicides in reducing malaria transmission and clinical malaria incidence: study protocol for a cluster randomized controlled trial. (2016) Zhou, Guofa; Wiseman, Virginia; Atieli, Harrysone E; Lee, Ming-Chieh; Githeko, Andrew K; Yan, Guiyun

2015

Generalizing boundaries for triangular designs, and efficacy estimation at extended follow-ups. (2015) Allison, Annabel; Edwards, Tansy; Omollo, Raymond; Alves, Fabiana; Magirr, Dominic; E Alexander, Neal D

Sample size calculation for a stepped wedge trial. (2015) Baio, Gianluca; Copas, Andrew; Ambler, Gareth; Hargreaves, James; Beard, Emma; Omar, Rumana Z

Informal Health Provider and Practical Approach to Lung Health interventions to improve the detection of chronic airways disease and tuberculosis at primary care level in Malawi: study protocol for a randomised controlled trial. (2015) Banda, Hastings T; Mortimer, Kevin; Bello, George AF; Mbera, Grace B; Namakhoma, Ireen; Thomson, Rachael; Nyirenda, Moffat J; Faragher, Brian; Madan, Jason; Malmborg, Rasmus; Stenberg, Berthe; Mpunga, James; Mwagomba, Beatrice; Gama, Elvis; Piddock, Katherine; Squire, Stephen B

Stepped wedge randomised controlled trials: systematic review of studies published between 2010 and 2014. (2015) Beard, Emma; Lewis, James J; Copas, Andrew; Davey, Calum; Osrin, David; Baio, Gianluca; Thompson, Jennifer A; Fielding, Katherine L; Omar, Rumana Z; Ononge, Sam; Hargreaves, James; Prost, Audrey

Interventions in randomised controlled trials in surgery: issues to consider during trial design. (2015) Blencowe, Natalie S; Brown, Julia M; Cook, Jonathan A; Metcalfe, Chris; Morton, Dion G; Nicholl, Jon; Sharples, Linda D; Treweek, Shaun; Blazeby, Jane M; Members of the MRC Hub for Trials Methodology Research Network W

Remedial after-school support classes offered in rural Gambia (The SCORE trial): study protocol for a cluster randomized controlled trial. (2015) Boone, Peter; Camara, Alpha; Eble, Alex; Elbourne, Diana; Fernandes, Samory; Frost, Chris; Jayanty, Chitra; Lenin, Maitri; Silva, Ana Filipa

The quality of reporting of pilot and feasibility cluster randomised trials: a systematic review. (2015) Coleman, Claire; Leyrat, Clemence; Eldridge, Sandra

Designing a stepped wedge trial: three main designs, carry-over effects and randomisation approaches. (2015) Copas, Andrew J; Lewis, James J; Thompson, Jennifer A; Davey, Calum; Baio, Gianluca; Hargreaves, James R

Assessing sensitivity to assumptions in mixed effects analyses of stepped-wedge trials. (2015) Davey, C; Thompson, JA

Analysis and reporting of stepped wedge randomised controlled trials: synthesis and critical appraisal of published studies, 2010 to 2014. (2015) Davey, Calum; Hargreaves, James; Thompson, Jennifer A; Copas, Andrew J; Beard, Emma; Lewis, James J; Fielding, Katherine L

"I never expected that it would happen, coming to ask me such questions":Ethical aspects of asking children about violence in resource poor settings. (2015) Devries, Karen M; Child, Jennifer C; Elbourne, Diana; Naker, Dipak; Heise, Lori

Complier-average causal effects for multivariate outcomes: an instrumental variable approach with application to health economics. (2015) DiazOrdaz, Karla; Franchini, Angelo; Grieve, Richard

Evaluation of a point-of-care tuberculosis test-and-treat algorithm on early mortality in people with HIV accessing antiretroviral therapy (TB Fast Track study): study protocol for a cluster randomised controlled trial. (2015) Fielding, Katherine L; Charalambous, Salome; Hoffmann, Christopher J; Johnson, Suzanne; Tlali, Mpho; Dorman, Susan E; Vassall, Anna; Churchyard, Gavin J; Grant, Alison D

Five questions to consider before conducting a stepped wedge trial. (2015) Hargreaves, James R; Copas, Andrew J; Beard, Emma; Osrin, David; Lewis, James J; Davey, Calum; Thompson, Jennifer A; Baio, Gianluca; Fielding, Katherine L; Prost, Audrey

How important is randomisation in a stepped wedge trial? (2015) Hargreaves, James R; Prost, Audrey; Fielding, Katherine L; Copas, Andrew J

Exploring the role and function of trial steering committees: results of an expert panel meeting. (2015) Harman, Nicola L; Conroy, Elizabeth J; Lewis, Steff C; Murray, Gordon; Norrie, John; Sydes, Matt R; Lane, J Athene; Altman, Douglas G; Baigent, Colin; Bliss, Judith M; Campbell, Marion K; Elbourne, Diana; Evans, Stephen; Sandercock, Peter; Gamble, Carrol

The three stages of building and testing mid-level theories in a realist RCT: a theoretical and methodological case-example. (2015) Jamal, Farah; Fletcher, Adam; Shackleton, Nichola; Elbourne, Diana; Viner, Russell; Bonell, Chris

Effects of study design and allocation on self-reported alcohol consumption: randomized trial. (2015) Kypri, Kypros; Wilson, Amanda; Attia, John; Sheeran, Paschal J; McCambridge, Jim

Evaluating the effect of innovative motivation and supervision approaches on community health worker performance and retention in Uganda and Mozambique: study protocol for a randomised controlled trial. (2015) Källander, Karin; Strachan, Daniel; Soremekun, Seyi; Hill, Zelee; Lingam, Raghu; Tibenderana, James; Kasteng, Frida; Vassall, Anna; Meek, Sylvia; Kirkwood, Betty

Challenges to undertaking randomised trials with looked after children in social care settings. (2015) Mezey, Gillian; Robinson, Fiona; Campbell, Rona; Gillard, Steve; Macdonald, Geraldine; Meyer, Deborah; Bonell, Chris; White, Sarah

AMBITION-cm: intermittent high dose AmBisome on a high dose fluconazole backbone for cryptococcal meningitis induction therapy in sub-Saharan Africa: study protocol for a randomized controlled trial. (2015) Molefi, Mooketsi; Chofle, Awilly A; Molloy, Síle F; Kalluvya, Samuel; Changalucha, John M; Cainelli, Francesca; Leeme, Tshepo; Lekwape, Nametso; Goldberg, Drew W; Haverkamp, Miriam; Bisson, Gregory P; Perfect, John R; Letang, Emili; Fenner, Lukas; Meintjes, Graeme; Burton, Rosie; Makadzange, Tariro; Ndhlovu, Chiratidzo E; Hope, William; Harrison, Thomas S; Jarvis, Joseph N

The Lake Victoria Island Intervention Study on Worms and Allergy-related diseases (LaVIISWA): study protocol for a randomised controlled trial. (2015) Nampijja, Margaret; Webb, Emily L; Kaweesa, James; Kizindo, Robert; Namutebi, Milly; Nakazibwe, Esther; Oduru, Gloria; Kabuubi, Prossy; Kabagenyi, Joyce; Kizito, Dennison; Muhangi, Lawrence; Akello, Mirriam; Verweij, Jaco J; Nerima, Barbara; Tukahebwa, Edridah; Elliott, Alison M; LaVIISWA trial team

The gametocytocidal efficacy of primaquine in malaria asymptomatic carriers treated with dihydroartemisinin-piperaquine in The Gambia (PRINOGAM): study protocol for a randomised controlled trial. (2015) Okebe, Joseph; Bousema, Teun; Affara, Muna; DiTanna, GianLuca; Eziefula, Alice C; Jawara, Musa; Nwakanma, Davis; Amambua-Ngwa, Alfred; Van Geertruyden, Jean-Pierre; Drakeley, Chris; D'Alessandro, Umberto

Investigating the non-specific effects of BCG vaccination on the innate immune system in Ugandan neonates: study protocol for a randomised controlled trial. (2015) Prentice, Sarah; Webb, Emily L; Dockrell, Hazel M; Kaleebu, Pontiano; Elliott, Alison M; Cose, Stephen

Logistic, ethical, and political dimensions of stepped wedge trials: critical review and case studies. (2015) Prost, Audrey; Binik, Ariella; Abubakar, Ibrahim; Roy, Anjana; De Allegri, Manuela; Mouchoux, Christelle; Dreischulte, Tobias; Ayles, Helen; Lewis, James J; Osrin, David

PREVENTT: preoperative intravenous iron to treat anaemia in major surgery: study protocol for a randomised controlled trial. (2015) Richards, Toby; Clevenger, Ben; Keidan, Jane; Collier, Tim; Klein, Andrew A; Anker, Stefan D; Kelly, John D

Baseline characteristics, analysis plan and report on feasibility for the Prevention Of Decline in Cognition After Stroke Trial (PODCAST). (2015) Scutt, Polly; Blackburn, Dan; Krishnan, Kailash; Ballard, Clive; Burns, Alistair; Ford, Gary A; Mant, Jonathan; Passmore, Peter; Pocock, Stuart; Reckless, John; Sprigg, Nikola; Stewart, Rob; Wardlaw, Joanna M; Bath, Philip M

The effectiveness and cost-effectiveness of the peer-delivered Thinking Healthy Programme for perinatal depression in Pakistan and India: the SHARE study protocol for randomised controlled trials. (2015) Sikander, Siham; Lazarus, Anisha; Bangash, Omer; Fuhr, Daniela C; Weobong, Benedict; Krishna, Revathi N; Ahmad, Ikhlaq; Weiss, Helen A; Price, LeShawndra; Rahman, Atif; Patel, Vikram

Qualitative and mixed methods research in trials. (2015) Snowdon, Claire

Considering the design effect for the stepped wedge trial: what can it tell us? (2015) Thompson, J; Fielding, K; Hargreaves, J; Copas, A

Making randomised trials more efficient: report of the first meeting to discuss the Trial Forge platform. (2015) Treweek, Shaun; Altman, Doug G; Bower, Peter; Campbell, Marion; Chalmers, Iain; Cotton, Seonaidh; Craig, Peter; Crosby, David; Davidson, Peter; Devane, Declan; Duley, Lelia; Dunn, Janet; Elbourne, Diana; Farrell, Barbara; Gamble, Carrol; Gillies, Katie; Hood, Kerry; Lang, Trudie; Littleford, Roberta; Loudon, Kirsty; McDonald, Alison; McPherson, Gladys; Nelson, Annmarie; Norrie, John; Ramsay, Craig; Sandercock, Peter; Shanahan, Daniel R; Summerskill, William; Sydes, Matt; Williamson, Paula; Clarke, Mike

Development of a composite outcome score for a complex intervention - measuring the impact of Community Health Workers. (2015) Watt, Hilary; Harris, Matthew; Noyes, Jane; Whitaker, Rhiannon; Hoare, Zoe; Edwards, Rhiannon Tudor; Haines, Andy

2014

Adapted motivational interviewing to improve the uptake of treatment for glaucoma in Nigeria: study protocol for a randomized controlled trial. (2014) Abdull, Mohammed M; Gilbert, Clare; McCambridge, Jim; Evans, Jennifer

Initiating change locally in bullying and aggression through the school environment (INCLUSIVE): study protocol for a cluster randomised controlled trial. (2014) Bonell, Chris; Allen, Elizabeth; Christie, Deborah; Elbourne, Diana; Fletcher, Adam; Grieve, Richard; LeGood, Rosa; Mathiot, Anne; Scott, Stephen; Wiggins, Meg; Viner, Russell M

Uthando Lwethu ('our love'): a protocol for a couples-based intervention to increase testing for HIV: a randomized controlled trial in rural KwaZulu-Natal, South Africa. (2014) Darbes, Lynae A; van Rooyen, Heidi; Hosegood, Victoria; Ngubane, Thulani; Johnson, Mallory O; Fritz, Katherine; McGrath, Nuala

Theory of Change: a theory-driven approach to enhance the Medical Research Council's framework for complex interventions. (2014) De Silva, Mary J; Breuer, Erica; Lee, Lucy; Asher, Laura; Chowdhary, Neerja; Lund, Crick; Patel, Vikram

Using marketing theory to inform strategies for recruitment: a recruitment optimisation model and the txt2stop experience. (2014) Galli, Leandro; Knight, Rosemary; Robertson, Steven; Hoile, Elizabeth; Oladapo, Olubukola; Francis, David; Free, Caroline

HPTN 071 (PopART): rationale and design of a cluster-randomised trial of the population impact of an HIV combination prevention intervention including universal testing and treatment - a study protocol for a cluster randomised trial. (2014) Hayes, Richard; Ayles, Helen; Beyers, Nulda; Sabapathy, Kalpana; Floyd, Sian; Shanaube, Kwame; Bock, Peter; Griffith, Sam; Moore, Ayana; Watson-Jones, Deborah; Fraser, Christophe; Vermund, Sten H; Fidler, Sarah; HPTN 071 (PopART) Study Team

Coping with persistent pain, effectiveness research into self-management (COPERS): statistical analysis plan for a randomised controlled trial. (2014) Kahan, Brennan C; Diaz-Ordaz, Karla; Homer, Kate; Carnes, Dawn; Underwood, Martin; Taylor, Stephanie Jc; Bremner, Stephen A; Eldridge, Sandra

The percutaneous coronary intervention prior to transcatheter aortic valve implantation (ACTIVATION) trial: study protocol for a randomized controlled trial. (2014) Khawaja, Muhammed Zeeshan; Wang, Duolao; Pocock, Stuart; Redwood, Simon Robert; Thomas, Martyn Rhys

Computer-assisted cognitive-behavioral therapy for adolescent depression in primary care clinics in Santiago, Chile (YPSA-M): study protocol for a randomized controlled trial. (2014) Martínez, Vania; Martínez, Pablo; Vöhringer, Paul A; Araya, Ricardo; Rojas, Graciela

Introducing rapid diagnostic tests for malaria into drug shops in Uganda: design and implementation of a cluster randomized trial. (2014) Mbonye, Anthony K; Magnussen, Pascal; Chandler, Clare IR; Hansen, Kristian S; Lal, Sham; Cundill, Bonnie; Lynch, Caroline A; Clarke, Siân E

Assessing the external validity of a randomized controlled trial of anthelminthics in mothers and their children in Entebbe, Uganda. (2014) Millard, James D; Muhangi, Lawrence; Sewankambo, Moses; Ndibazza, Juliet; Elliott, Alison M; Webb, Emily L

Ethical and scientific considerations for patient enrollment into concurrent clinical trials. (2014) Myles, Paul S; Williamson, Elizabeth; Oakley, Justin; Forbes, Andrew

An efficacy and mechanism evaluation study of Levosimendan for the Prevention of Acute oRgan Dysfunction in Sepsis (LeoPARDS): protocol for a randomized controlled trial. (2014) Orme, Robert M L'E; Perkins, Gavin D; McAuley, Daniel F; Liu, Kathleen D; Mason, Alexina J; Morelli, Andrea; Singer, Mervyn; Ashby, Deborah; Gordon, Anthony C

The effectiveness and cost-effectiveness of lay counsellor-delivered psychological treatments for harmful and dependent drinking and moderate to severe depression in primary care in India: PREMIUM study protocol for randomized controlled trials. (2014) Patel, Vikram; Weobong, Benedict; Nadkarni, Abhijit; Weiss, Helen A; Anand, Arpita; Naik, Smita; Bhat, Bhargav; Pereira, Jesina; Araya, Ricardo; Dimidjian, Sona; Hollon, Steven D; King, Michael; McCambridge, Jim; McDaid, David; Murthy, Pratima; Velleman, Richard; Fairburn, Christopher G; Kirkwood, Betty

HALT-IT--tranexamic acid for the treatment of gastrointestinal bleeding: study protocol for a randomised controlled trial. (2014) Roberts, Ian; Coats, Timothy; Edwards, Phil; Gilmore, Ian; Jairath, Vipul; Ker, Katharine; Manno, Daniela; Shakur, Haleema; Stanworth, Simon; Veitch, Andrew

Community-based scheduled screening and treatment of malaria in pregnancy for improved maternal and infant health in The Gambia, Burkina Faso and Benin: study protocol for a randomized controlled trial. (2014) Scott, Susana; Mens, Petra F; Tinto, Halidou; Nahum, Alain; Ruizendaal, Esmée; Pagnoni, Franco; Grietens, Koen Peeters; Kendall, Lindsay; Bojang, Kalifa; Schallig, Henk; D'Alessandro, Umberto

MObile Technology for Improved Family Planning: update to randomised controlled trial protocol. (2014) Smith, Chris; Ngo, Thoai D; Edwards, Phil; Free, Caroline

2013

Long-term consistent use of a vaginal microbicide gel among HIV-1 sero-discordant couples in a phase III clinical trial (MDP 301) in rural south-west Uganda. (2013) Abaasa, Andrew; Crook, Angela; Gafos, Mitzy; Anywaine, Zacchaeus; Levin, Jonathan; Wandiembe, Symon; Nanoo, Ananta; Nunn, Andrew; McCormack, Sheena; Hayes, Richard; Kamali, Anatoli

First steps: study protocol for a randomized controlled trial of the effectiveness of the Group Family Nurse Partnership (gFNP) program compared to routine care in improving outcomes for high-risk mothers and their children and preventing abuse. (2013) Barnes, Jacqueline; Aistrop, Dipti; Allen, Elizabeth; Barlow, Jane; Elbourne, Diana; Macdonald, Geraldine; Melhuish, Edward; Petrou, Stavros; Pink, Joshua; Snowdon, Claire; Spiby, Helen; Stuart, Jane; Sturgess, Joanna

Prevention of Decline in Cognition after Stroke Trial (PODCAST): a study protocol for a factorial randomised controlled trial of intensive versus guideline lowering of blood pressure and lipids. (2013) Blackburn, Daniel J; Krishnan, Kailash; Fox, Lydia; Ballard, Clive; Burns, Alistair; Ford, Gary A; Mant, Jonathan; Passmore, Peter; Pocock, Stuart; Reckless, John; Sprigg, Nikola; Stewart, Rob; Wardlaw, Joanna; Bath, Philip MW

The impact of hotspot-targeted interventions on malaria transmission: study protocol for a cluster-randomized controlled trial. (2013) Bousema, Teun; Stevenson, Jennifer; Baidjoe, Amrish; Stresman, Gillian; Griffin, Jamie T; Kleinschmidt, Immo; Remarque, Edmond J; Vulule, John; Bayoh, Nabie; Laserson, Kayla; Desai, Meghna; Sauerwein, Robert; Drakeley, Chris; Cox, Jonathan

Psychological advocacy toward healing (PATH): study protocol for a randomized controlled trial. (2013) Brierley, Gwen; Agnew-Davies, Roxane; Bailey, Jayne; Evans, Maggie; Fackrell, Morgan; Ferrari, Giulia; Hollinghurst, Sandra; Howard, Louise; Howarth, Emma; Malpass, Alice; Metters, Carol; Peters, Tim J; Saeed, Fayeza; Sardhina, Lynnmarie; Sharp, Debbie; Feder, Gene S

The Good Schools Toolkit to prevent violence against children in Ugandan primary schools: study protocol for a cluster randomised controlled trial. (2013) Devries, Karen M; Allen, Elizabeth; Child, Jennifer C; Walakira, Eddy; Parkes, Jenny; Elbourne, Diana; Watts, Charlotte; Naker, Dipak

RApid Primary care Initiation of Drug treatment for Transient Ischaemic Attack (RAPID-TIA): study protocol for a pilot randomised controlled trial. (2013) Edwards, Duncan; Fletcher, Kate; Deller, Rachel; McManus, Richard; Lasserson, Daniel; Giles, Matthew; Sims, Don; Norrie, John; McGuire, Graham; Cohn, Simon; Whittle, Fiona; Hobbs, Vikki; Weir, Christopher; Mant, Jonathan

Using evidence from observational healthcare data to inform a trial design. (2013) Hansen, CH; Murray, G; Sharpe, M

An integrated approach to the development of a Bayesian response-adaptive dose-finding study using sas and winbugs. (2013) Hansen, CH; Weir, C; Warner, P; Critchley, H

Evaluation of the impact of immediate versus WHO recommendations-guided antiretroviral therapy initiation on HIV incidence: the ANRS 12249 TasP (Treatment as Prevention) trial in Hlabisa sub-district, KwaZulu-Natal, South Africa: study protocol for a cluster randomised controlled trial. (2013) Iwuji, Collins C; Orne-Gliemann, Joanna; Tanser, Frank; Boyer, Sylvie; Lessells, Richard J; Lert, France; Imrie, John; Bärnighausen, Till; Rekacewicz, Claire; Bazin, Brigitte; Newell, Marie-Louise; Dabis, François; ANRS 12249 TasP Study Group

Feasibility intervention trial of two types of improved cookstoves in three resource-limited settings: study protocol for a randomized controlled trial. (2013) Klasen, Elizabeth; Miranda, J Jaime; Khatry, Subarna; Menya, Diana; Gilman, Robert H; Tielsch, James M; Kennedy, Caitlin; Dreibelbis, Robert; Naithani, Neha; Kimaiyo, Sylvester; Chiang, Marilu; Carter, E Jane; Sherman, Charles B; Breysse, Patrick N; Checkley, William; COCINAS Trial Working Group

An oral preparation of Lactobacillus acidophilus for the treatment of uncomplicated acute watery diarrhoea in Vietnamese children: study protocol for a multicentre, randomised, placebo-controlled trial. (2013) Kolader, Marion-Eliëtte; Vinh, Ha; Ngoc Tuyet, Pham Thi; Thompson, Corinne; Wolbers, Marcel; Merson, Laura; Campbell, James I; Ngoc Dung, Tran Thi; Manh Tuan, Ha; Vinh Chau, Nguyen Van; Farrar, Jeremy; van Doorn, H Rogier; Baker, Stephen

Impact of a novel molecular TB diagnostic system in patients at high risk of TB mortality in rural South Africa (Uchwepheshe): study protocol for a cluster randomised trial. (2013) Lessells, Richard J; Cooke, Graham S; McGrath, Nuala; Nicol, Mark P; Newell, Marie-Louise; Godfrey-Faussett, Peter

Improving community development by linking agriculture, nutrition and education: design of a randomised trial of "home-grown" school feeding in Mali. (2013) Masset, Edoardo; Gelli, Aulo

Investigating the relationship between predictability and imbalance in minimisation: a simulation study. (2013) McPherson, Gladys C; Campbell, Marion K; Elbourne, Diana R

Challenges for consent and community engagement in the conduct of cluster randomized trial among school children in low income settings: experiences from Kenya. (2013) Okello, George; Jones, Caroline; Bonareri, Maureen; Ndegwa, Sarah N; McHaro, Carlos; Kengo, Juddy; Kinyua, Kevin; Dubeck, Margaret M; Halliday, Katherine E; Jukes, Matthew CH; Molyneux, Sassy; Brooker, Simon J

A community-based intervention for primary prevention of cardiovascular diseases in the slums of Nairobi: the SCALE UP study protocol for a prospective quasi-experimental community-based trial. (2013) Oti, Samuel O; van de Vijver, Steven JM; Kyobutungi, Catherine; Gomez, Gabriela B; Agyemang, Charles; Moll van Charante, Eric P; Brewster, Lizzy M; Hendriks, Marleen E; Schultsz, Constance; Ettarh, Remare; Ezeh, Alex; Lange, Joep

MObile Technology for Improved Family Planning Services (MOTIF): study protocol for a randomised controlled trial. (2013) Smith, Chris; Vannak, Uk; Sokhey, Ly; Ngo, Thoai D; Gold, Judy; Khut, Khemrin; Edwards, Phil; Rathavy, Tung; Free, Caroline

When enough is enough: how the decision was made to stop the FEAST trial: data and safety monitoring in an African trial of Fluid Expansion As Supportive Therapy (FEAST) for critically ill children. (2013) Todd, Jim; Heyderman, Robert S; Musoke, Philippa; Peto, Tim

2012

A community mobilisation intervention to prevent violence against women and reduce HIV/AIDS risk in Kampala, Uganda (the SASA! Study): study protocol for a cluster randomised controlled trial. (2012) Abramsky, Tanya; Devries, Karen; Kiss, Ligia; Francisco, Leilani; Nakuti, Janet; Musuya, Tina; Kyegombe, Nambusi; Starmann, Elizabeth; Kaye, Dan; Michau, Lori; Watts, Charlotte

Efficacy of early neonatal vitamin A supplementation in reducing mortality during infancy in Ghana, India and Tanzania: study protocol for a randomized controlled trial. (2012) Bahl, R; Bhandari, N; Dube, B; Edmond, K; Fawzi, W; Fontaine, O; Kaur, J; Kirkwood, BR; Martines, J; Masanja, H; Mazumder, S; Msham, S; Newton, S; Oleary, M; Ruben, J; Shannon, C; Smith, E; Taneja, S; Yoshida, S

Cluster randomized trial in the general practice research database: 2. Secondary prevention after first stroke (eCRT study): study protocol for a randomized controlled trial. (2012) Dregan, Alex; van Staa, Tjeerd; McDermott, Lisa; McCann, Gerard; Ashworth, Mark; Charlton, Judith; Wolfe, Charles; Rudd, Anthony; Yardley, Lucy; Gulliford, Martin; eCRT Research Team

Alcohol email assessment and feedback study dismantling effectiveness for university students (AMADEUS-1): study protocol for a randomized controlled trial. (2012) McCambridge, Jim; Bendtsen, Preben; Bendtsen, Marcus; Nilsen, Per

Efficacy of early neonatal vitamin A supplementation in reducing mortality during infancy in Ghana, India and Tanzania: study protocol for a randomized controlled trial. (2012) NEOVITA Study Author Group; Bahl, Rajiv; Bhandari, Nita; Dube, Brinda; Edmond, Karen; Fawzi, Wafaie; Fontaine, Olivier; Kaur, Jasmine; Kirkwood, Betty R; Martines, Jose; Masanja, Honorati; Mazumder, Sarmila; Msham, Salum; Newton, Sam; Oleary, Maureen; Ruben, Julia; Shannon, Caitlin; Smith, Emily; Taneja, Sunita; Yoshida, Sachiyo

Diarrhea and dengue control in rural primary schools in Colombia: study protocol for a randomized controlled trial. (2012) Overgaard, Hans J; Alexander, Neal; Mátiz, Maria Ines; Jaramillo, Juan Felipe; Olano, Victor Alberto; Vargas, Sandra; Sarmiento, Diana; Lenhart, Audrey; Seidu, Razak; Stenström, Thor Axel

The Well London program--a cluster randomized trial of community engagement for improving health behaviors and mental wellbeing: baseline survey results. (2012) Phillips, Gemma; Renton, Adrian; Moore, Derek G; Bottomley, Christian; Schmidt, Elena; Lais, Shahana; Yu, Ge; Wall, Martin; Tobi, Patrick; Frostick, Caroline; Clow, Angela; Lock, Karen; Petticrew, Mark; Hayes, Richard

Brief intervention for alcohol misuse in people attending sexual health clinics: study protocol for a randomized controlled trial. (2012) Sanatinia, Rahil; Barrett, Barbara; Byford, Sarah; Dean, Madeleine; Green, John; Jones, Rachel; Leurent, Baptiste; Lingford-Hughes, Anne; Sweeting, Michael; Touquet, Robin; Tyrer, Peter; Ward, Helen; Crawford, Mike J

Information on blinding in registered records of clinical trials. (2012) Viergever, Roderik F; Ghersi, Davina

Lovastatin for adult patients with dengue: protocol for a randomised controlled trial. (2012) Whitehorn, James; Van Vinh Chau, Nguyen; Truong, Nguyen Thanh; Tai, Luong Thi Hue; Van Hao, Nguyen; Hien, Tran Tinh; Wolbers, Marcel; Merson, Laura; Dung, Nguyen Thi Phuong; Peeling, Rosanna; Simmons, Cameron; Wills, Bridget; Farrar, Jeremy

A cost-effectiveness analysis of provider interventions to improve health worker practice in providing treatment for uncomplicated malaria in Cameroon: a study protocol for a randomized controlled trial. (2012) Wiseman, Virginia; Mangham, Lindsay J; Cundill, Bonnie; Achonduh, Olivia A; Nji, Akindeh Mbuh; Njei, Abanda Ngu; Chandler, Clare; Mbacham, Wilfred F

A cost-effectiveness analysis of provider and community interventions to improve the treatment of uncomplicated malaria in Nigeria: study protocol for a randomized controlled trial. (2012) Wiseman, Virginia; Ogochukwu, Ezeoke; Emmanuel, Nwala; Lindsay J, Mangham; Bonnie, Cundill; Jane, Enemuo; Eloka, Uchegbu; Benjamin, Uzochukwu; Obinna, Onwujekwe

2011

The efficacy of a brief intervention in reducing hazardous drinking in working age men in Russia: the HIM (Health for Izhevsk men) individually randomised parallel group exploratory trial. (2011) Allen, Elizabeth; Polikina, Olga; Saburova, Lyudmila; McCambridge, Jim; Elbourne, Diana; Pakriev, Sergey; Nekrasova, Nadezhda; Vasilyev, Maxim; Tomlin, Keith; Oralov, Alexey; Gil, Artyom; McKee, Martin; Kiryanov, Nikolay; Leon, David A

European society of intensive care medicine study of therapeutic hypothermia (32-35 °C) for intracranial pressure reduction after traumatic brain injury (the Eurotherm3235Trial). (2011) Andrews, Peter JD; Sinclair, Helen Louise; Battison, Claire G; Polderman, Kees H; Citerio, Giuseppe; Mascia, Luciana; Harris, Bridget A; Murray, Gordon D; Stocchetti, Nino; Menon, David K; Shakur, Haleema; De Backer, Daniel; Eurotherm3235Trial collaborators

School-based intervention to improve the mental health of low-income, secondary school students in Santiago, Chile (YPSA): study protocol for a randomized controlled trial. (2011) Araya, Ricardo; Montgomery, Alan A; Fritsch, Rosemarie; Gunnell, David; Stallard, Paul; Noble, Sian; Martinez, Vania; Barroilhet, Sergio; Vohringer, Paul; Guajardo, Viviana; Cova, Felix; Gaete, Jorge; Gomez, Alejandro; Rojas, Graciela

Developing a placebo-controlled trial in surgery: issues of design, acceptability and feasibility. (2011) Campbell, MK; Entwistle, VA; Cuthbertson, BH; Skea, ZC; Sutherland, AG; McDonald, AM; Norrie, JD; Carlson, RV; Bridgman, S; KORAL study group

Collaborative community based care for people and their families living with schizophrenia in India: protocol for a randomised controlled trial. (2011) Chatterjee, Sudipto; Leese, Morven; Koschorke, Mirja; McCrone, Paul; Naik, Smita; John, Sujit; Dabholkar, Hamid; Goldsmith, Kimberley; Balaji, Madhumitha; Varghese, Mathew; Thara, Rangaswamy; Patel, Vikram; Thornicroft, Graham; COmmunity care for People with Schizophrenia in India (COPSI) gr

Assessing the efficacy of the healthy eating and lifestyle programme (HELP) compared with enhanced standard care of the obese adolescent in the community: study protocol for a randomized controlled trial. (2011) Christie, Deborah; Hudson, Lee; Mathiot, Anne; Cole, Tim J; Karlsen, Saffron; Kessel, A; Kinra, Sanjay; Morris, Steve; Nazareth, Irwin; Sovio, Ulla; Wong, Ian CK; Viner, Russell M

Assessing the efficacy of the Healthy Eating and Lifestyle Programme (HELP) compared with enhanced standard care of the obese adolescent in the community: study protocol for a randomized controlled trial. (2011) Christie, Deborah; Hudson, Lee; Mathiot, Anne; Cole, Tim J; Karlsen, Saffron; Kessel, Anthony; Kinra, Sanjay; Morris, Steve; Nazareth, Irwin; Sovio, Ulla; Wong, Ian CK; Viner, Russell M

The mesenchymal stem cells in multiple sclerosis (MSCIMS) trial protocol and baseline cohort characteristics: an open-label pre-test: post-test study with blinded outcome assessments. (2011) Connick, Peter; Kolappan, Madhan; Patani, Rickie; Scott, Michael A; Crawley, Charles; He, Xiao-Ling; Richardson, Karen; Barber, Kelly; Webber, Daniel J; Wheeler-Kingshott, Claudia AM; Tozer, Daniel J; Samson, Rebecca S; Thomas, David L; Du, Ming-Qing; Luan, Shi L; Michell, Andrew W; Altmann, Daniel R; Thompson, Alan J; Miller, David H; Compston, Alastair; Chandran, Siddharthan

Single-dose liposomal amphotericin B (AmBisome®) for the treatment of visceral leishmaniasis in East Africa: study protocol for a randomized controlled trial. (2011) Edwards, Tansy; Omollo, Raymond; Khalil, Eltahir AG; Yifru, Sisay; Musa, Brima; Musa, Ahmed; Wasunna, Monique; Smith, Peter G; Royce, Catherine; Ellis, Sally; Balasegaram, Manica; Hailu, Asrat

Cluster randomised trial in the General Practice Research Database: 1. Electronic decision support to reduce antibiotic prescribing in primary care (eCRT study). (2011) Gulliford, Martin C; van Staa, Tjeerd; McDermott, Lisa; Dregan, Alex; McCann, Gerard; Ashworth, Mark; Charlton, Judith; Grieve, Andrew P; Little, Paul; Moore, Michael V; Yardley, Lucy; electronic Cluster Randomised Trial Research Team eCRT Research

Effects of Study Design and Allocation on participant behaviour--ESDA: study protocol for a randomized controlled trial. (2011) Kypri, Kypros; McCambridge, Jim; Wilson, Amanda; Attia, John; Sheeran, Paschal; Bowe, Steve; Vater, Tina

Between-centre differences and treatment effects in randomized controlled trials: a case study in traumatic brain injury. (2011) Lingsma, Hester F; Roozenbeek, Bob; Perel, Pablo; Roberts, Ian; Maas, Andrew IR; Steyerberg, Ewout W

Using a business model approach and marketing techniques for recruitment to clinical trials. (2011) McDonald, Alison M; Treweek, Shaun; Shakur, Haleema; Free, Caroline; Knight, Rosemary; Speed, Chris; Campbell, Marion K

Safety and efficacy of miltefosine alone and in combination with sodium stibogluconate and liposomal amphotericin B for the treatment of primary visceral leishmaniasis in East Africa: study protocol for a randomized controlled trial. (2011) Omollo, Raymond; Alexander, Neal; Edwards, Tansy; Khalil, Eltahir AG; Younis, Brima M; Abuzaid, Abuzaid A; Wasunna, Monique; Njoroge, Njenga; Kinoti, Dedan; Kirigi, George; Dorlo, Thomas PC; Ellis, Sally; Balasegaram, Manica; Musa, Ahmed M

To assess whether indoor residual spraying can provide additional protection against clinical malaria over current best practice of long-lasting insecticidal mosquito nets in The Gambia: study protocol for a two-armed cluster-randomised trial. (2011) Pinder, Margaret; Jawara, Musa; Jarju, Lamin BS; Kandeh, Ballah; Jeffries, David; Lluberas, Manuel F; Mueller, Jenny; Parker, David; Bojang, Kalifa; Conway, David J; Lindsay, Steve W

Reduction of surgical site infection using a novel intervention (ROSSINI): study protocol for a randomised controlled trial. (2011) Pinkney, Thomas D; Bartlett, David C; Hawkins, William; Mak, Tony; Youssef, Haney; Futaba, Kaori; Harrison, Gareth; Gheorghe, Adrian; Bradbury, Jennifer M; Calvert, Melanie J; Dowswell, George; Magill, Laura; Redman, Val; Wilson, Sue; Leaper, David; Morton, Dion G; West Midlands Research Collaborative

Exploring meaning of participation in a clinical trial in a developing country setting: implications for recruitment. (2011) Reynolds, Joanna; Mangesho, Peter; Vestergaard, Lasse S; Chandler, Clare

Pilot randomized trial of therapeutic hypothermia with serial cranial ultrasound and 18-22 month follow-up for neonatal encephalopathy in a low resource hospital setting in Uganda: study protocol. (2011) Robertson, Nicola J; Hagmann, Cornelia F; Acolet, Dominique; Allen, Elizabeth; Nyombi, Natasha; Elbourne, Diana; Costello, Anthony; Jacobs, Ian; Nakakeeto, Margaret; Cowan, Frances

Reducing the environmental impact of trials: a comparison of the carbon footprint of the CRASH-1 and CRASH-2 clinical trials. (2011) Subaiya, Saleena; Hogg, Euan; Roberts, Ian

An effectiveness study of an integrated, community-based package for maternal, newborn, child and HIV care in South Africa: study protocol for a randomized controlled trial. (2011) Tomlinson, Mark; Doherty, Tanya; Jackson, Debra; Lawn, Joy E; Ijumba, Petrida; Colvin, Mark; Nkonki, Lungiswa; Daviaud, Emmanuelle; Goga, Ameena; Sanders, David; Lombard, Carl; Persson, Lars Åke; Ndaba, Thoko; Snetro, Gail; Chopra, Mickey

Randomised Evaluations of Accepted Choices in Treatment (REACT) trials: large-scale pragmatic trials within databases of routinely collected electronic healthcare records. (2011) van Staa, TP; Goldacre, B; Gulliford, M; Cassell, J; Pirmohamed, M; Taweel, A; Delaney, B; Smeeth, L

2010

Improving educational achievement and anaemia of school children: design of a cluster randomised trial of school-based malaria prevention and enhanced literacy instruction in Kenya. (2010) Brooker, Simon; Okello, George; Njagi, Kiambo; Dubeck, Margaret M; Halliday, Katherine E; Inyega, Hellen; Jukes, Matthew CH

Evaluation of exercise on individuals with dementia and their carers: a randomised controlled trial. (2010) Cerga-Pashoja, Arlinda; Lowery, David; Bhattacharya, Rahul; Griffin, Mark; Iliffe, Steve; Lee, James; Leonard, Claire; Ricketts, Sue; Strother, Lyn; Waters, Fiona; Ritchie, Craig W; Warner, James

The STRIPES trial--support to rural India's public education system. (2010) Eble, Alex; Mann, Vera; Bhakta, Preetha; Lakshminarayana, Rashmi; Frost, Chris; Elbourne, Diana; Boone, Peter

Questionnaires in clinical trials: guidelines for optimal design and administration. (2010) Edwards, Phil

Managing clinical trials. (2010) Farrell, Barbara; Kenyon, Sara; Shakur, Haleema

NEWHINTS cluster randomised trial to evaluate the impact on neonatal mortality in rural Ghana of routine home visits to provide a package of essential newborn care interventions in the third trimester of pregnancy and the first week of life: trial protocol. (2010) Kirkwood, Betty R; Manu, Alexander; Tawiah-Agyemang, Charlotte; ten Asbroek, Guus; Gyan, Thomas; Weobong, Benedict; Lewandowski, R Eric; Soremekun, Seyi; Danso, Samuel; Pitt, Catherine; Hanson, Kara; Owusu-Agyei, Seth; Hill, Zelee

The WOMAN Trial (World Maternal Antifibrinolytic Trial): tranexamic acid for the treatment of postpartum haemorrhage: an international randomised, double blind placebo controlled trial. (2010) Shakur, Haleema; Elbourne, Diana; Gülmezoglu, Metin; Alfirevic, Zarko; Ronsmans, Carine; Allen, Elizabeth; Roberts, Ian

The BRACELET Study: surveys of mortality in UK neonatal and paediatric intensive care trials. (2010) Snowdon, Claire; Harvey, Sheila E; Brocklehurst, Peter; Tasker, Robert C; Platt, Martin P Ward; Allen, Elizabeth; Elbourne, Diana

2009

Microbicides Development Programme: design of a phase III trial to measure the efficacy of the vaginal microbicide PRO 2000/5 for HIV prevention. (2009) Nunn, Andrew; McCormack, Sheena; Crook, Angela M; Pool, Robert; Rutterford, Clare; Hayes, Richard

The BRAIN TRIAL: a randomised, placebo controlled trial of a Bradykinin B2 receptor antagonist (Anatibant) in patients with traumatic brain injury. (2009) Shakur, Haleema; Andrews, Peter; Asser, Toomas; Balica, Laura; Boeriu, Cristian; Quintero, Juan Diego Ciro; Dewan, Yashbir; Druwé, Patrick; Fletcher, Olivia; Frost, Chris; Hartzenberg, Bennie; Mantilla, Jorge Mejia; Murillo-Cabezas, Francisco; Pachl, Jan; Ravi, Ramalingam R; Rätsep, Indrek; Sampaio, Cristina; Singh, Manmohan; Svoboda, Petr; Roberts, Ian

Response to: The BRAIN TRIAL: a randomised, placebo controlled trial of a Bradykinin B2 receptor antagonist (Anatibant) in patients with traumatic brain injury. (2009) Simmon, Vincent F

2008

ZAMSTAR, The Zambia South Africa TB and HIV Reduction Study: design of a 2 x 2 factorial community randomized trial. (2008) Ayles, Helen M; Sismanidis, Charalambos; Beyers, Nulda; Hayes, Richard J; Godfrey-Faussett, Peter

Study protocol for a three-armed randomized controlled trial to assess whether house screening can reduce exposure to malaria vectors and reduce malaria transmission in The Gambia. (2008) Kirby, Matthew J; Milligan, Paul J; Conway, David J; Lindsay, Steve W

Improving the outcomes of primary care attenders with common mental disorders in developing countries: a cluster randomized controlled trial of a collaborative stepped care intervention in Goa, India. (2008) Patel, Vikram H; Kirkwood, Betty R; Pednekar, Sulochana; Araya, Ricardo; King, Michael; Chisholm, Daniel; Simon, Gregory; Weiss, Helen

2007

Marketing and clinical trials: a case study. (2007) Francis, David; Roberts, Ian; Elbourne, Diana R; Shakur, Haleema; Knight, Rosemary C; Garcia, Jo; Snowdon, Claire; Entwistle, Vikki A; McDonald, Alison M; Grant, Adrian M; Campbell, Marion K

Figures in clinical trial reports: current practice & scope for improvement. (2007) Pocock, Stuart J; Travison, Thomas G; Wruck, Lisa M

Does it matter if clinicians recruiting for a trial don't understand what the trial is really about? Qualitative study of surgeons' experiences of participation in a pragmatic multi-centre RCT. (2007) Ziebland, Sue; Featherstone, Katie; Snowdon, Claire; Barker, Karen; Frost, Helen; Fairbank, Jeremy

2006

Fracture risk and the use of a diuretic (indapamide SR) +/- perindopril: a substudy of the Hypertension in the Very Elderly Trial (HYVET). (2006) Bulpitt, Christopher J; Peters, Ruth; Staessen, Jan A; Thijs, Lutgarde; De Vernejoul, Marie-Christine; Fletcher, Astrid E; Beckett, Nigel S

CRASH2 in Germany [ISRCTN86750102]. (2006) Chung, CH; Freiberger, A; Kalkum, M; Luntz, SP; Shakur, H; Seiler, CM

Lessons and implications from a mass immunization campaign in squatter settlements of Karachi, Pakistan: an experience from a cluster-randomized double-blinded vaccine trial [NCT00125047]. (2006) Khan, Mohammad Imran; Ochiai, Rion Leon; Hamza, Hasan Bin; Sahito, Shah Muhammad; Habib, Muhammad Atif; Soofi, Sajid Bashir; Bhutto, Naveed Sarwar; Rasool, Shahid; Puri, Mahesh K; Ali, Mohammad; Wasan, Shafi Mohammad; Khan, Mohammad Jawed; Abu-Elyazeed, Remon; Ivanoff, Bernard; Galindo, Claudia M; Pang, Tikki; Donner, Allan; von Seidlein, Lorenz; Acosta, Camilo J; Clemens, John D; Nizami, Shaikh Qamaruddin; Bhutta, Zulfiqar A

Increasing participation of cancer patients in randomised controlled trials: a systematic review. (2006) Mc Daid, Catriona; Hodges, Zoé; Fayter, Debra; Stirk, Lisa; Eastwood, Alison

What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies. (2006) McDonald, Alison M; Knight, Rosemary C; Campbell, Marion K; Entwistle, Vikki A; Grant, Adrian M; Cook, Jonathan A; Elbourne, Diana R; Francis, David; Garcia, Jo; Roberts, Ian; Snowdon, Claire

CHARITY: Chagas cardiomyopathy bisoprolol intervention study: a randomized double-blind placebo force-titration controlled study with Bisoprolol in patients with chronic heart failure secondary to Chagas cardiomyopathy [NCT00323973]. (2006) Quiros, Franklin R; Morillo, Carlos A; Casas, Juan P; Cubillos, Luz A; Silva, Federico A

Financial considerations in the conduct of multi-centre randomised controlled trials: evidence from a qualitative study. (2006) Snowdon, Claire; Elbourne, Diana R; Garcia, Jo; Campbell, Marion K; Entwistle, Vikki A; Francis, David; Grant, Adrian M; Knight, Rosemary C; McDonald, Alison M; Roberts, Ian