Sally Hopewell
MSc, DPhil
Professor of Clinical Trials and Evidence Synthesis
- Theme Lead for Clinical Trials
My key areas of research expertise are in the design, conduct and transparent reporting of randomized trials and systematic reviews. I have published a number of research studies in these areas and have been instrumental in the development of key reporting guidelines including the CONSORT and SPIRIT Statements.
In my current role I am involved in leading the design and delivery of clinical trials within the OCTRU portfolio. I am co-chief investigator on several NIHR funded trials in the areas of rehabilitation and musculoskeletal sciences and co-investigator on a number of other NIHR funded trials and evidence syntheses.
Previously, I worked at the Centre for Statistics in Medicine (2007 – 2015) on an MRC-funded programme of research related to CONSORT and the conduct and reporting of clinical trials. I also worked, and continue to collaborate with, the Centre d’Epidemiologie Clinique (2012 – present), University Paris Descartes, on research activities related to the methodology of systematic reviews and randomized trials. Prior to this I worked at the UK Cochrane Centre (2004 – 2012) and with the NHS National Blood Service (2010 – 2012) systematic review programme. In 2005, I was awarded a D.Phil at the University of Oxford on research into the effects of unpublished data in systematic reviews.
I have a particular interest in clinical trial registration, data sharing, transparent reporting of trial protocols, development of core outcome sets, pilot trials and trials of complex interventions. I am a member of the advisory board for Current Controlled Trials, a member of the NIHR Open Research Advisory Board and member of the NIHR Health Technology Assessment Clinical Evaluation and Trials Board (2018-2023). I regularly carry out peer review for high impact medical journals and various funding bodies (e.g. NIHR and Medical Research Council).
I have considerable experience in the teaching and supervision of MSc and DPhil students both at the University of Oxford and Université Paris Descartes; and previously for the London School of Hygiene and Tropical Medicine and Stellenbosch University in South Africa.
Key publications
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An update to SPIRIT and CONSORT reporting guidelines to enhance transparency in randomized trials.
Hopewell S. et al, (2022), Nat med
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Progressive exercise compared with best practice advice, with or without corticosteroid injection, for the treatment of patients with rotator cuff disorders (GRASP): a multicentre, pragmatic, 2 × 2 factorial, randomised controlled trial.
Hopewell S. et al, (2021), Lancet, 398, 416 - 428
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Guidelines for Reporting Trial Protocols and Completed Trials Modified Due to the COVID-19 Pandemic and Other Extenuating Circumstances: The CONSERVE 2021 Statement.
Orkin AM. et al, (2021), Jama
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TIDieR-Placebo: A guide and checklist for reporting placebo and sham controls.
Howick J. et al, (2020), Plos med, 17
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Reporting of Multi-Arm Parallel-Group Randomized Trials: Extension of the CONSORT 2010 Statement.
Juszczak E. et al, (2019), Jama, 321, 1610 - 1620
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RoB 2: a revised tool for assessing risk of bias in randomised trials.
Sterne JAC. et al, (2019), Bmj, 366
Recent publications
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SPIRIT 2025 statement: updated guideline for protocols of randomized trials.
Chan A-W. et al, (2025), Nat med
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SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials.
Hróbjartsson A. et al, (2025), Bmj, 389
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SPIRIT 2025 statement: updated guideline for protocols of randomised trials.
Chan A-W. et al, (2025), Bmj, 389
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CONSORT 2025 statement: updated guideline for reporting randomized trials.
Hopewell S. et al, (2025), Nat med
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CONSORT 2025 explanation and elaboration: updated guideline for reporting randomised trials.
Hopewell S. et al, (2025), Bmj, 389
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CONSORT 2025 statement: updated guideline for reporting randomised trials.
Hopewell S. et al, (2025), Bmj, 389
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CONSORT 2025 statement: updated guideline for reporting randomised trials.
Hopewell S. et al, (2025), Lancet
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Patient and public involvement in research reporting.
Staniszewska S. et al, (2025), Bmj, 389
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CONSORT 2025 statement: Updated guideline for reporting randomised trials.
Hopewell S. et al, (2025), Plos med, 22
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Describing the landscape of nutrition- and diet-related randomized controlled trials: metaresearch study of protocols published between 2012 and 2022.
Silva FM. et al, (2025), Am j clin nutr, 121, 882 - 891
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SPIRIT 2025 statement: Updated guideline for protocols of randomised trials.
Chan A-W. et al, (2025), Plos med, 22
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Guidance for protocol content and reporting of factorial randomised trials: explanation and elaboration of the CONSORT 2010 and SPIRIT 2013 extensions.
Kahan BC. et al, (2025), Bmj, 388
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CONSORT-DEFINE explanation and elaboration: recommendations for enhancing reporting quality and impact of early phase dose-finding clinical trials.
Rekowski J. et al, (2025), Eclinicalmedicine, 79
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SPIRIT-DEFINE explanation and elaboration: recommendations for enhancing quality and impact of early phase dose-finding clinical trials protocols.
Ursino M. et al, (2025), Eclinicalmedicine, 79
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Integrating environmental outcomes in randomised clinical trials: a call to action.
Petersen JJ. et al, (2024), Lancet
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Facilitating the transition from hospital to home after hip fracture surgery: a qualitative study from the HIP HELPER trial.
Welsh A. et al, (2024), Bmc geriatr, 24
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A cross-sectional study assessing visual abstracts of randomized trials revealed inadequate reporting and high prevalence of spin.
Duran M. et al, (2024), J clin epidemiol, 176
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Reporting completeness of nutrition and diet-related randomised controlled trials protocols.
Silva FM. et al, (2024), Clin nutr, 43, 1626 - 1635
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Reports of randomised control trials should begin and conclude with up-to-date systematic reviews of other relevant trials: a 25-year audit of the quality of trial reports.
Clarke M. et al, (2024), J r soc med, 117, 212 - 216
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Development of a topic‐specific bibliographic database supporting the updates of SPIRIT 2013 and CONSORT 2010
Østengaard L. et al, (2024), Cochrane evidence synthesis and methods, 2
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Anti-TNF (adalimumab) injection for the treatment of pain-predominant early-stage frozen shoulder: the Anti-Freaze-Feasibility randomised controlled trial.
Hopewell S. et al, (2024), Bmj open, 14
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Methods used to develop the SPIRIT 2024 and CONSORT 2024 Statements.
Tunn R. et al, (2024), J clin epidemiol, 169
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Pharmacological interventions for early-stage frozen shoulder: a systematic review and network meta-analysis.
Berner JE. et al, (2024), Rheumatology (oxford)
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Hospital-based caregiver intervention for people following hip fracture surgery (HIP HELPER): multicentre randomised controlled feasibility trial with embedded qualitative study in England.
Smith TO. et al, (2023), Bmj open, 13
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Reporting of Factorial Randomized Trials: Extension of the CONSORT 2010 Statement.
Kahan BC. et al, (2023), Jama, 330, 2106 - 2114
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Consensus Statement for Protocols of Factorial Randomized Trials: Extension of the SPIRIT 2013 Statement.
Kahan BC. et al, (2023), Jama netw open, 6
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Perspectives of informal caregivers who support people following hip fracture surgery: a qualitative study embedded within the HIP HELPER feasibility trial.
Welsh A. et al, (2023), Bmj open, 13
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Enhancing quality and impact of early phase dose-finding clinical trial protocols: SPIRIT Dose-finding Extension (SPIRIT-DEFINE) guidance.
Yap C. et al, (2023), Bmj, 383
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Enhancing reporting quality and impact of early phase dose-finding clinical trials: CONSORT Dose-finding Extension (CONSORT-DEFINE) guidance.
Yap C. et al, (2023), Bmj, 383
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Patient-Relevant Outcomes Following First Revision Total Knee Arthroplasty, by Diagnosis: An Analysis of Implant Survivorship, Mortality, Serious Medical Complications, and Patient-Reported Outcome Measures Utilizing the National Joint Registry Data Set.
Sabah SA. et al, (2023), J bone joint surg am, 105, 1611 - 1621
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Patient-relevant outcomes following elective, aseptic revision knee arthroplasty: a systematic review.
Sabah SA. et al, (2023), Syst rev, 12
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Development of consensus-driven SPIRIT and CONSORT extensions for early phase dose-finding trials: the DEFINE study.
Solovyeva O. et al, (2023), Bmc med, 21
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Describing the landscape of nutrition or diet-related randomised controlled trials: meta-research study of protocols published between 2012 and 2022
Silva FM. et al, (2023)
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Reminding Peer Reviewers of Reporting Guideline Items to Improve Completeness in Published Articles: Primary Results of 2 Randomized Trials.
Speich B. et al, (2023), Jama netw open, 6
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Anti-TNF (adalimumab) injection for the treatment of adults with frozen shoulder during the pain predominant stage protocol for a multi-centre, randomised, double blind, parallel group, feasibility trial
Hopewell S. et al, (2023), Nihr open research, 2, 28 - 28
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Recommendations for progression criteria during external randomised pilot trial design, conduct, analysis and reporting.
Mellor K. et al, (2023), Pilot feasibility stud, 9
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Tailored exercise management (TEMPO) versus usual care for people aged 80 years or older with hip/knee osteoarthritis: study protocol for a feasibility randomised controlled trial.
Nicolson PJA. et al, (2023), Pilot feasibility stud, 9
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SPIRIT and CONSORT extensions for early phase dose-finding clinical trials: the DEFINE (DosE-FIndiNg Extensions) study protocol.
Espinasse A. et al, (2023), Bmj open, 13
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Completeness of Reporting in Diet- and Nutrition-Related Randomized Controlled Trials and Systematic Reviews With Meta-Analysis: Protocol for 2 Independent Meta-Research Studies.
Silva F. et al, (2023), Jmir res protoc, 12
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79MO Developing international consensus-driven SPIRIT and CONSORT extensions for early phase dose-finding clinical trials: The DEFINE (DosE FIndiNg Extensions) study
Solovyeva O. et al, (2023), Esmo open, 8
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Pilot and feasibility studies: extending the conceptual framework.
Bond C. et al, (2023), Pilot feasibility stud, 9
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Determining external randomised pilot trial feasibility in preparation for a definitive trial: a web-based survey of corresponding authors of external pilot trial publications.
Mellor K. et al, (2023), Trials, 24
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A scoping review identifies multiple comments suggesting modifications to SPIRIT 2013 and CONSORT 2010.
Nejstgaard CH. et al, (2023), J clin epidemiol
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CONSORT 2010 Statement: updated guidelines for reporting parallel group randomized trials
Schulz KF. et al, (2023), Japanese pharmacology and therapeutics, 51, 1891 - 1899
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Protocol for a meta-research study of protocols for diet or nutrition-related trials published in indexed journals: general aspects of study design, rationale and reporting limitations.
Silva FM. et al, (2022), Bmj open, 12
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Progressive exercise versus best practice advice for adults aged 50 years or over after ankle fracture: the AFTER pilot randomised controlled trial.
Keene DJ. et al, (2022), Bmj open, 12
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Inclusion of progression criteria in external randomised pilot trials: a cross-sectional study of funding applications submitted to the NIHR Research for Patient Benefit Programme.
Mellor K. et al, (2022), Trials, 23
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Evaluation of cultural competency in a South African cluster randomised controlled trial: lessons learned for trial reporting standards.
Siegfried NL. et al, (2022), Trials, 23
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Completeness of Reporting in Diet- and Nutrition-Related Randomized Controlled Trials and Systematic Reviews With Meta-Analysis: Protocol for 2 Independent Meta-Research Studies (Preprint)
Silva F. et al, (2022)
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An update to SPIRIT and CONSORT reporting guidelines to enhance transparency in randomized trials.
Hopewell S. et al, (2022), Nat med
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Corrigendum: Progressive exercise compared with best-practice advice, with or without corticosteroid injection, for rotator cuff disorders: the GRASP factorial RCT.
Hopewell S. et al, (2022), Health technol assess, 25, 159 - 160
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One-off physiotherapy and at-home exercise are effective in treating shoulder pain.
Saul H. et al, (2022), Bmj, 378
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A longitudinal assessment of trial protocols approved by research ethics committees: The Adherance to SPIrit REcommendations in the UK (ASPIRE-UK) study.
Speich B. et al, (2022), Trials, 23
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A core outcome set for lower limb orthopaedic surgery for children with cerebral palsy: An international multi-stakeholder consensus study.
Almoajil H. et al, (2022), Dev med child neurol
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A meta-research study of randomized controlled trials found infrequent and delayed availability of protocols.
Schönenberger CM. et al, (2022), J clin epidemiol
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Reporting quality of clinical trial protocols: a repeated cross-sectional study about the Adherence to SPIrit Recommendations in Switzerland, CAnada and GErmany (ASPIRE-SCAGE).
Gryaznov D. et al, (2022), Bmj open, 12
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Anti-TNF (adalimumab) injection for the treatment of adults with frozen shoulder during the pain predominant stage protocol for a multi-centre, randomised, double blind, parallel group, feasibility trial
Hopewell S. et al, (2022), Nihr open research, 2, 28 - 28
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A COMORBIDITY-TAILORED EXERCISE INTERVENTION FOR PEOPLE AGED 80 YEARS OR OLDER WITH HIP/KNEE OSTEOARTHRITIS: INTERVENTION DEVELOPMENT USING BEHAVIOUR CHANGE THEORY
Nicolson PJ. et al, (2022), Osteoarthritis and cartilage, 30, S197 - S198
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Nonregistration, discontinuation, and nonpublication of randomized trials: A repeated metaresearch analysis.
Speich B. et al, (2022), Plos med, 19
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How are progression decisions made following external randomised pilot trials? A qualitative interview study and framework analysis.
Mellor K. et al, (2022), Trials, 23
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Outcomes of importance to children and young adults with cerebral palsy, their parents and health professionals following lower limb orthopaedic surgery: A qualitative study to inform a Core Outcome Set.
Almoajil H. et al, (2022), Health expect
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Exploring the factors that influence stakeholders’ expectations and subsequent perception of lower limb orthopaedic surgical outcomes for ambulant children with cerebral palsy – a qualitative study
Almoajil H. et al, (2022), Disability and rehabilitation, 1 - 8
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The need for reporting guidelines for early phase dose-finding trials: Dose-Finding CONSORT Extension.
Yap C. et al, (2022), Nat med
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CONSORT and Its Extensions for Reporting Clinical Trials
Hopewell S. et al, (2022), Principles and Practice of Clinical Trials, 2073 - 2087
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A feasibility study to assess the design of a multicentre randomized controlled trial of the clinical and cost-effectiveness of a caregiving intervention for people following hip fracture surgery.
Smith T. et al, (2021), Bone jt open, 2, 909 - 920
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Reliability of Trial Information Across Registries for Trials With Multiple Registrations: A Systematic Review.
Speich B. et al, (2021), Jama netw open, 4
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Patient-reported outcome measures following revision knee replacement: a review of PROM instrument utilisation and measurement properties using the COSMIN checklist.
Sabah SA. et al, (2021), Bmj open, 11
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A Guideline for Reporting Mediation Analyses of Randomized Trials and Observational Studies: The AGReMA Statement.
Lee H. et al, (2021), Jama, 326, 1045 - 1056
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The Effect of Therapeutic Exercise Interventions on Physical and Psychosocial Outcomes in Adults Aged 80 Years and Older: A Systematic Review and Meta-Analysis.
Nicolson PJA. et al, (2021), J aging phys act, 1 - 18
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Base of thumb osteoarthritis in UK interface services-a cohort and survey-based study to assess current practice.
Dean BJF. et al, (2021), Rheumatology (oxford), 60, 4094 - 4102
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Findings from the patch augmented rotator cuff surgery (PARCS) feasibility study.
Cook JA. et al, (2021), Pilot feasibility stud, 7
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Progressive exercise compared with best-practice advice, with or without corticosteroid injection, for rotator cuff disorders: the GRASP factorial RCT.
Hopewell S. et al, (2021), Health technol assess, 25, 1 - 158
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Progressive exercise compared with best-practice advice, with or without corticosteroid injection, for rotator cuff disorders: the GRASP factorial RCT.
Hopewell S. et al, (2021), Health technol assess, 25, 1 - 158
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Progressive exercise compared with best practice advice, with or without corticosteroid injection, for the treatment of patients with rotator cuff disorders (GRASP): a multicentre, pragmatic, 2 × 2 factorial, randomised controlled trial.
Hopewell S. et al, (2021), Lancet, 398, 416 - 428
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Randomised study within a trial (SWAT) to evaluate personalised versus standard text message prompts for increasing trial participant response to postal questionnaires (PROMPTS).
Cureton L. et al, (2021), Trials, 22
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Randomised study within a trial (SWAT) to evaluate personalised versus standard text
message prompts for increasing trial participant response to postal questionnaires
(PROMPTS)
CURETON L. et al, (2021), Trials
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When Factorial Design Randomized Control Trials are no plain sailing
MARIAN I. et al, (2021)
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Challenges in Factorial Design Randomized Control Trials
MARIAN I. et al, (2021)
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Progression from external pilot to definitive randomised controlled trial: a methodological review of progression criteria reporting.
Mellor K. et al, (2021), Bmj open, 11
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Guidelines for Reporting Trial Protocols and Completed Trials Modified Due to the COVID-19 Pandemic and Other Extenuating Circumstances: The CONSERVE 2021 Statement.
Orkin AM. et al, (2021), Jama
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Reporting quality of trial protocols improved for non-regulated interventions but not regulated interventions: a repeated cross-sectional study.
Lohner S. et al, (2021), J clin epidemiol
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Compression stockings for preventing deep vein thrombosis in airline passengers.
Clarke MJ. et al, (2021), Cochrane database syst rev, 4
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Transparency of informed consent in pilot and feasibility studies is inadequate: a single-center quality assurance study.
Khan MIU. et al, (2021), Pilot feasibility stud, 7
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Preferred reporting items for journal and conference abstracts of systematic reviews and meta-analyses of diagnostic test accuracy studies (PRISMA-DTA for Abstracts): checklist, explanation, and elaboration.
Cohen JF. et al, (2021), Bmj, 372
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A meta-research study revealed several challenges in obtaining placebos for investigator-initiated drug trials.
Speich B. et al, (2021), J clin epidemiol, 131, 70 - 78
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Cognitive-behavioural therapy for a variety of conditions: an overview of systematic reviews and panoramic meta-analysis.
Fordham B. et al, (2021), Health technol assess, 25, 1 - 378
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Patch augmentation surgery for rotator cuff repair: the PARCS mixed-methods feasibility study.
Cook JA. et al, (2021), Health technol assess, 25, 1 - 138
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Alternative agents to prophylactic platelet transfusion for preventing bleeding in people with thrombocytopenia due to chronic bone marrow failure: A meta-analysis and systematic review (Russian Translation of Cochrane Plain Language Summary)
Desborough MJR. et al, (2021), Journal of modern oncology, 23, 635 - 636
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Base of thumb osteoarthritis (BTOA) in UK interface services-a cohort and survey based study to assess current practice.
Dean BJF. et al, (2020), Rheumatology (oxford)
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Use of implantable meshes for augmented rotator cuff repair: a systematic review and meta-analysis.
Baldwin M. et al, (2020), Bmj open, 10
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Patients' and parents' views about lower limb orthopaedic surgery for ambulant children and young people with cerebral palsy: a qualitative evidence synthesis.
Almoajil H. et al, (2020), J child orthop, 14, 562 - 573
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Multifactorial interventions for preventing falls in older people living in the community: a systematic review and meta-analysis of 41 trials and almost 20 000 participants.
Hopewell S. et al, (2020), Br j sports med, 54, 1340 - 1350
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Rationale and design of repeated cross-sectional studies to evaluate the reporting quality of trial protocols: the Adherence to SPIrit REcommendations (ASPIRE) study and associated projects.
Gryaznov D. et al, (2020), Trials, 21
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Progressive exercise compared with best practice advice, with or without corticosteroid injection, for the treatment of rotator cuff disorders: statistical analysis plan for the Getting it Right: Addressing Shoulder Pain (GRASP) 2 × 2 factorial multicentre randomised controlled trial.
Marian IR. et al, (2020), Trials, 21
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TIDieR-Placebo: A guide and checklist for reporting placebo and sham controls.
Howick J. et al, (2020), Plos med, 17
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Items for consideration in a reporting guideline for mediation analyses: a Delphi study.
Cashin AG. et al, (2020), Bmj evid based med
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Prediction of RECRUITment In randomized clinical Trials (RECRUIT-IT)-rationale and design for an international collaborative study.
Kasenda B. et al, (2020), Trials, 21
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Exercise for preventing falls in older people living in the community: an abridged Cochrane systematic review.
Sherrington C. et al, (2020), Br j sports med, 54, 885 - 891
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Blood transfusion for preventing primary and secondary stroke in people with sickle cell disease.
Estcourt LJ. et al, (2020), Cochrane database syst rev, 7
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Preoperative blood transfusions for sickle cell disease.
Estcourt LJ. et al, (2020), Cochrane database syst rev, 7