Paula R Williamson

Paula R Williamson

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Identifying Possible Outcome Domains from Existing Outcome Measures to Inform an OMERACT Core Domain Set for Safety in Rheumatology Trials.

J Rheumatol 2019 Sep 1;46(9):1173-1178. Epub 2019 May 1.

From the Clinical Epidemiology, Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen; Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital, Denmark; David Geffen School of Medicine, Division of Rheumatology, University of California at Los Angeles (UCLA), Los Angeles; Division of Immunology and Rheumatology, Stanford University, Stanford; Healthy Motivation, and Global Alliance for Musculoskeletal Health, Bone and Joint Decade, Santa Barbara, California; Section of Rheumatology and Clinical Immunology, University of Texas MD Anderson Cancer Center, Houston, Texas; Division of Rheumatology, Duke University School of Medicine, Durham; UCB Bio Sciences Inc., Raleigh, North Carolina; Rutgers-Robert Wood Johnson Medical School, New Brunswick, New Jersey; SDG LLC, Cambridge, Massachusetts, USA; Department of Family Medicine, McGill University, Montreal, Quebec; Health Services Research, Department of Medicine, University of Calgary, Cumming School of Medicine, Calgary, Alberta; Division of Rheumatology, Department of Medicine, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa; Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada; Institute of Translational Medicine, University of Liverpool, Liverpool, UK; Department of Epidemiology and Biostatistics, Amsterdam Rheumatology and Immunology Center, VU University Medical Center, Amsterdam, the Netherlands; Centre for Health Policy Melbourne School of Population and Global Health, University of Melbourne, Melbourne; University of Sydney, Sydney, Australia.

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http://dx.doi.org/10.3899/jrheum.190196DOI Listing
September 2019

Assessing the impact of a research funder's recommendation to consider core outcome sets.

PLoS One 2019 13;14(9):e0222418. Epub 2019 Sep 13.

MRC North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, Liverpool, United Kingdom.

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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0222418PLOS
September 2019

The OMERACT-OARSI Core Domain Set for Measurement in Clinical Trials of Hip and/or Knee Osteoarthritis.

J Rheumatol 2019 Aug 15;46(8):981-989. Epub 2019 Jan 15.

From the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, and UK National Institute for Health Research (NIHR) Oxford Biomedical Research Centre, John Radcliffe Hospital, Oxford; Institute of Translational Medicine, University of Liverpool, Liverpool; Faculty of Health and Medical Sciences, University of Surrey, Guildford; Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; NIHR Leeds Biomedical Research Centre, Leeds, UK; Department of Medicine, Faculty of Medicine, and Institute of Health Policy, Management, and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto; Division of Rheumatology, Department of Medicine, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa; Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada; Institute of Bone and Joint Research, Department of Rheumatology, School of Medicine, University of Sydney and Royal North Shore Hospital; Inner West Psychology; School of Biological, Earth and Environmental Sciences, University of New South Wales, Sydney, Australia; Department of Epidemiology and Biostatistics, Amsterdam University Medical Centers, location VUmc; Amsterdam University Medical Centre, Department of Medical Humanities, Amsterdam Public Health, Amsterdam; Departments of Rheumatology and Clinical Epidemiology, Leiden University Medical Centre, Leiden, the Netherlands; Musculoskeletal Statistics Unit, the Parker Institute, Bispebjerg and Frederiksberg Hospital, and Department of Rheumatology, Odense University Hospital; Center for Muscle and Joint Health, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark; Université de Lorraine, Approches Épidémiologiques et Psychologiques (APEMAC), Nancy, France; Division of Rheumatology, Allergy and Immunology, Thurston Arthritis Research Center, University of North Carolina, Chapel Hill, North Carolina; Department of Physical Medicine and Rehabilitation, Northwestern University Feinberg School of Medicine, Chicago, Illinois; Sections of Clinical Epidemiology and Rheumatology, Boston University School of Medicine, Boston, Massachusetts; TissueGene Inc., Rockville; Division of Rheumatology and Clinical Immunology, Department of Medicine and Division of Gerontology, Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland, USA; Merck Biopharma, Merck KGaA, Darmstadt; University Pain Centre, University Hospital Carl Gustav Carus, Dresden, Germany; Department of Regenerative Medicine, State Research Institute Centre for Innovative Medicine, Vilnius, Lithuania; Faculty of Humanities and Social Sciences, University of Lucerne, Lucerne, Switzerland.

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http://www.jrheum.org/lookup/doi/10.3899/jrheum.181194
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http://dx.doi.org/10.3899/jrheum.181194DOI Listing
August 2019

Uptake of the OMERACT-OARSI Hip and Knee Osteoarthritis Core Outcome Set: Review of Randomized Controlled Trials from 1997 to 2017.

J Rheumatol 2019 Aug 1;46(8):976-980. Epub 2019 Mar 1.

From the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford; School of Health and Social Care, London South Bank University, London; Institute of Translational Medicine, University of Liverpool, Liverpool; Faculty of Health and Medical Sciences, University of Surrey, Guildford; Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; National Institute for Health Research (NIHR) Leeds Biomedical Research Centre (BRC), Leeds, UK; Department of Medicine, Faculty of Medicine, and Institute of Health Policy, Management, and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto; Division of Rheumatology, Department of Medicine, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa; Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada; Institute of Bone and Joint Research, Department of Rheumatology, School of Medicine, University of Sydney and Royal North Shore Hospital, Sydney, Australia; Department of Epidemiology and Biostatistics, Amsterdam University Medical Centres, location VUmc; Amsterdam University Medical Centre, Department of Medical Humanities, Amsterdam Public Health, Amsterdam; Departments of Rheumatology and Clinical Epidemiology, Leiden University Medical Centre, Leiden, the Netherlands; Musculoskeletal Statistics Unit, the Parker Institute, Bispebjerg and Frederiksberg Hospital and Department of Rheumatology, Odense University Hospital; Center for Muscle and Joint Health, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark; Université de Lorraine, APEMAC, Nancy, France; Division of Rheumatology, Allergy and Immunology, Thurston Arthritis Research Center, University of North Carolina, Chapel Hill, North Carolina; Department of Physical Medicine and Rehabilitation, Northwestern University Feinberg School of Medicine, Chicago; Sections of Clinical Epidemiology and Rheumatology, Boston University School of Medicine, Boston; TissueGene Inc., Rockville; Division of Rheumatology and Clinical Immunology, Department of Medicine and Division of Gerontology, Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland, USA; Merck Biopharma, Merck KGaA, Darmstadt; University Pain Centre, University Hospital Carl Gustav Carus, Dresden, Germany; Inner West Psychology; Institute of Bone and Joint Research, Department of Rheumatology, School of Medicine, University of Sydney and Royal North Shore Hospital; School of Biological, Earth and Environmental Sciences, University of New South Wales, Sydney, Australia; Department of Regenerative Medicine, State Research Institute Centre for Innovative Medicine, Vilnius, Lithuania; Faculty of Humanities and Social Sciences, University of Lucerne, Lucerne, Switzerland.

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http://www.jrheum.org/lookup/doi/10.3899/jrheum.181066
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http://dx.doi.org/10.3899/jrheum.181066DOI Listing
August 2019

Improvement was needed in the standards of development for cancer core outcome sets.

J Clin Epidemiol 2019 Aug 19;112:36-44. Epub 2019 Apr 19.

Department of Biostatistics, MRC North West Hub for Trials Methodology Research, University of Liverpool, Liverpool, United Kingdom.

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https://linkinghub.elsevier.com/retrieve/pii/S08954356183107
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http://dx.doi.org/10.1016/j.jclinepi.2019.04.006DOI Listing
August 2019

Pirfenidone in Heart Failure with Preserved Ejection Fraction-Rationale and Design of the PIROUETTE Trial.

Cardiovasc Drugs Ther 2019 Aug;33(4):461-470

Division of Cardiovascular Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, University of Manchester, Oxford Road, Manchester, M13 9PL, UK.

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http://dx.doi.org/10.1007/s10557-019-06876-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6689029PMC
August 2019

Industry funding was associated with increased use of core outcome sets.

J Clin Epidemiol 2019 Jul 18;115:90-97. Epub 2019 Jul 18.

Department of Biostatistics, University of Liverpool, Liverpool, UK.

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http://dx.doi.org/10.1016/j.jclinepi.2019.07.007DOI Listing
July 2019

Higher number of items associated with significantly lower response rates in COS Delphi surveys.

J Clin Epidemiol 2019 Apr 15;108:110-120. Epub 2018 Dec 15.

MRC North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, Liverpool, UK.

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http://dx.doi.org/10.1016/j.jclinepi.2018.12.010DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6438267PMC
April 2019

Cost-Effectiveness Analysis of Adalimumab for the Treatment of Uveitis Associated with Juvenile Idiopathic Arthritis.

Ophthalmology 2019 Mar 16;126(3):415-424. Epub 2018 Oct 16.

Bristol Medical School, University of Bristol, Bristol, United Kingdom; University Hospitals Bristol NHS Foundation Trust, Bristol, United Kingdom.

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http://dx.doi.org/10.1016/j.ophtha.2018.09.043DOI Listing
March 2019

Reducing attrition within clinical trials: The communication of retention and withdrawal within patient information leaflets.

PLoS One 2018 31;13(10):e0204886. Epub 2018 Oct 31.

North West Hub for Trials Methodology Research/ Clinical Trial Research Centre, Biostatistics, University of Liverpool, Liverpool, United Kingdom.

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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0204886PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6209179PMC
March 2019

Core Outcome Set-STAndardised Protocol Items: the COS-STAP Statement.

Trials 2019 Feb 11;20(1):116. Epub 2019 Feb 11.

MRC North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, Block F Waterhouse Building, 1-5 Brownlow Street, Liverpool, L69 3GL, UK.

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http://dx.doi.org/10.1186/s13063-019-3230-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6371434PMC
February 2019

Incorporating patients' perspectives into the initial stages of core outcome set development: a rapid review of qualitative studies of type 2 diabetes.

BMJ Open Diabetes Res Care 2019 28;7(1):e000615. Epub 2019 Feb 28.

MRC North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, Liverpool, UK.

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http://dx.doi.org/10.1136/bmjdrc-2018-000615DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6398822PMC
February 2019

Involving people living with dementia in research: an accessible modified Delphi survey for core outcome set development.

Trials 2019 Jan 6;20(1):12. Epub 2019 Jan 6.

Division of Health Research, Faculty of Health and Medicine, Furness College, Lancaster University, Lancaster, LA1 4YG, UK.

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http://dx.doi.org/10.1186/s13063-018-3069-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6322337PMC
January 2019

A framework for prospectively defining progression rules for internal pilot studies monitoring recruitment.

Stat Methods Med Res 2018 12 7;27(12):3612-3627. Epub 2017 Jun 7.

1 Department of Mathematics and Statistics, Medical and Pharmaceutical Statistics Research Unit, Lancaster University, Lancaster, UK.

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http://dx.doi.org/10.1177/0962280217708906DOI Listing
December 2018

A core outcome set for clinical trials of chemoradiotherapy interventions for anal cancer (CORMAC): a patient and health-care professional consensus.

Lancet Gastroenterol Hepatol 2018 12;3(12):865-873

Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK; Manchester Cancer Research Centre and National Institute for Health Research, Manchester Biomedical Research Centre, University of Manchester, Manchester, UK; Colorectal and Peritoneal Oncology Centre, Christie National Health Service Foundation Trust, Manchester, UK.

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http://dx.doi.org/10.1016/S2468-1253(18)30264-4DOI Listing
December 2018

Reporting of outcomes in gastric cancer surgery trials: a systematic review.

BMJ Open 2018 10 17;8(10):e021796. Epub 2018 Oct 17.

Division of Dentistry, School of Medical Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.

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http://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2018-02179
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http://dx.doi.org/10.1136/bmjopen-2018-021796DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6196805PMC
October 2018

Outcome reporting bias in trials: a methodological approach for assessment and adjustment in systematic reviews.

BMJ 2018 Sep 28;362:k3802. Epub 2018 Sep 28.

MRC North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, Liverpool L69 3GL, UK.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6161807PMC
http://dx.doi.org/10.1136/bmj.k3802DOI Listing
September 2018

Correction to: Survey indicated that core outcome set development is increasingly including patients, being conducted internationally and using Delphi surveys.

Trials 2018 08 8;19(1):430. Epub 2018 Aug 8.

MRC North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, Liverpool, UK.

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http://dx.doi.org/10.1186/s13063-018-2595-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6081937PMC
August 2018

Time-dependent efficacy of longitudinal biomarker for clinical endpoint.

Stat Methods Med Res 2018 06 17;27(6):1909-1924. Epub 2016 Oct 17.

Institute of Translational Medicine, University of Liverpool, Liverpool, UK.

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http://dx.doi.org/10.1177/0962280216673084DOI Listing
June 2018

A taxonomy has been developed for outcomes in medical research to help improve knowledge discovery.

J Clin Epidemiol 2018 04 28;96:84-92. Epub 2017 Dec 28.

MRC North West Hub for Trials Methodology Research, Department of Biostatistics, Institute of Translational Medicine, University of Liverpool, Liverpool L69 3GS, UK. Electronic address:

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http://dx.doi.org/10.1016/j.jclinepi.2017.12.020DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5854263PMC
April 2018

Survey indicated that core outcome set development is increasingly including patients, being conducted internationally and using Delphi surveys.

Trials 2018 Feb 17;19(1):113. Epub 2018 Feb 17.

MRC North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, Liverpool, UK.

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http://dx.doi.org/10.1186/s13063-018-2493-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5816387PMC
February 2018

A randomized trial comparing three Delphi feedback strategies found no evidence of a difference in a setting with high initial agreement.

J Clin Epidemiol 2018 01 7;93:1-8. Epub 2017 Oct 7.

Department of Biostatistics, University of Liverpool, Liverpool, UK.

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http://dx.doi.org/10.1016/j.jclinepi.2017.09.024DOI Listing
January 2018

A systematic review of primary outcomes and outcome measure reporting in randomized trials evaluating treatments for pre-eclampsia.

Int J Gynaecol Obstet 2017 Dec 7;139(3):262-267. Epub 2017 Sep 7.

Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.

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http://dx.doi.org/10.1002/ijgo.12298DOI Listing
December 2017

SCORE-IT (Selecting Core Outcomes for Randomised Effectiveness trials In Type 2 diabetes): a systematic review of registered trials.

Trials 2017 Dec 15;18(1):597. Epub 2017 Dec 15.

Department of Biostatistics, Institute of Translational Medicine, University of Liverpool, Liverpool, L69 3GL, UK.

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http://dx.doi.org/10.1186/s13063-017-2317-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5732470PMC
December 2017

A core outcome set for localised prostate cancer effectiveness trials.

BJU Int 2017 11 3;120(5B):E64-E79. Epub 2017 May 3.

Academic Urology Unit, University of Aberdeen, Aberdeen, UK.

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http://dx.doi.org/10.1111/bju.13854DOI Listing
November 2017

Core Outcome Set-STAndards for Development: The COS-STAD recommendations.

PLoS Med 2017 Nov 16;14(11):e1002447. Epub 2017 Nov 16.

MRC North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, Liverpool, United Kingdom.

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http://dx.doi.org/10.1371/journal.pmed.1002447DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5689835PMC
November 2017

Core outcome research measures in anal cancer (CORMAC): protocol for systematic review, qualitative interviews and Delphi survey to develop a core outcome set in anal cancer.

BMJ Open 2017 Nov 22;7(11):e018726. Epub 2017 Nov 22.

Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.

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http://dx.doi.org/10.1136/bmjopen-2017-018726DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5719280PMC
November 2017

Do systematic reviews still exclude studies with "no relevant outcome data"?

BMJ 2017 08 21;358:j3919. Epub 2017 Aug 21.

Department of Biostatistics, University of Liverpool, Liverpool, UK.

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http://dx.doi.org/10.1136/bmj.j3919DOI Listing
August 2017

How Much Participant Outcome Data Is Missing from Sight: Findings from a Cohort of Trials Submitted to a German Research Ethics Committee.

PLoS One 2016 17;11(6):e0157883. Epub 2016 Jun 17.

MRC North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, Liverpool, United Kingdom.

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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0157883PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4912080PMC
July 2017

Choosing Important Health Outcomes for Comparative Effectiveness Research: An Updated Review and Identification of Gaps.

PLoS One 2016 14;11(12):e0168403. Epub 2016 Dec 14.

MRC North West Hub for Trials Methodology Research (NWHTMR), Department of Biostatistics, University of Liverpool, Liverpool, United Kingdom.

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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0168403PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5156438PMC
July 2017

Citation analysis did not provide a reliable assessment of core outcome set uptake.

J Clin Epidemiol 2017 Jun 23;86:153-159. Epub 2017 Mar 23.

MRC North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, Block F Waterhouse Building, 1-5 Brownlow Street, Liverpool L69 3GL, United Kingdom.

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http://dx.doi.org/10.1016/j.jclinepi.2017.03.003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5513440PMC
June 2017

Improving core outcome set development: qualitative interviews with developers provided pointers to inform guidance.

J Clin Epidemiol 2017 Jun 8;86:140-152. Epub 2017 May 8.

Department of Psychology, Health and Society, University of Liverpool, Whelan Building, Brownlow Hill, Liverpool L69 3GB. Electronic address:

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http://dx.doi.org/10.1016/j.jclinepi.2017.04.024DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5513443PMC
June 2017

The COMET Handbook: version 1.0.

Trials 2017 Jun 20;18(Suppl 3):280. Epub 2017 Jun 20.

MRC North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, Block F Waterhouse Building, 1-5 Brownlow Street, Liverpool, L69 3GL, UK.

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http://dx.doi.org/10.1186/s13063-017-1978-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5499094PMC
June 2017

A methodological approach for assessing the uptake of core outcome sets using ClinicalTrials.gov: findings from a review of randomised controlled trials of rheumatoid arthritis.

BMJ 2017 May 17;357:j2262. Epub 2017 May 17.

MRC North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, Liverpool L69 3GL, UK.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5434459PMC
http://dx.doi.org/10.1136/bmj.j2262DOI Listing
May 2017

Clinical trials and systematic reviews addressing similar interventions for the same condition do not consider similar outcomes to be important: a case study in HIV/AIDS.

J Clin Epidemiol 2017 Apr 27;84:85-94. Epub 2017 Feb 27.

Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, Room E6152, Baltimore, MD 21205, USA.

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http://dx.doi.org/10.1016/j.jclinepi.2017.02.005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5441957PMC
April 2017

Adalimumab plus Methotrexate for Uveitis in Juvenile Idiopathic Arthritis.

N Engl J Med 2017 04;376(17):1637-1646

From University Hospitals Bristol NHS Foundation Trust (A.V.R., A.D.D., D.B.) and the School of Clinical Sciences, University of Bristol (A.V.R., A.D.D.), Bristol, National Institute for Health Research (NIHR) Biomedical Research Centre at Moorfields Eye Hospital and University College London Institute of Ophthalmology (A.D.D., P.W.) and Great Ormond Street Hospital (S.C.-L., C.E.), London, Institute of Translational Medicine, University of Liverpool (A.P.J., A.M., P.R.W., B.H., H.H., M.W.B.), and the Department of Paediatric Rheumatology, Alder Hey Children's NHS Foundation Trust (M.W.B.), Liverpool, and Bangor University, Bangor (D.H.) - all in the United Kingdom.

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http://dx.doi.org/10.1056/NEJMoa1614160DOI Listing
April 2017

Informing efficient randomised controlled trials: exploration of challenges in developing progression criteria for internal pilot studies.

BMJ Open 2017 02 17;7(2):e013537. Epub 2017 Feb 17.

Medical Research Council ConDuCT-II Hub for Trials Methodology Research, School of Social and Community Medicine, University of Bristol, Bristol, UK.

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http://dx.doi.org/10.1136/bmjopen-2016-013537DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5318608PMC
February 2017

Assessing the feasibility of injectable growth-promoting therapy in Crohn's disease.

Pilot Feasibility Stud 2016 5;2:71. Epub 2016 Dec 5.

Centre for Digestive Diseases, Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, 4 Newark Street, London, E1 2AT UK.

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http://dx.doi.org/10.1186/s40814-016-0112-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5153677PMC
December 2016

Core Outcome Set-STAndards for Reporting: The COS-STAR Statement.

PLoS Med 2016 Oct 18;13(10):e1002148. Epub 2016 Oct 18.

MRC North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, Liverpool, United Kingdom.

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http://dx.doi.org/10.1371/journal.pmed.1002148DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5068732PMC
October 2016

Individual participant data meta-analyses compared with meta-analyses based on aggregate data.

Cochrane Database Syst Rev 2016 Sep 6;9:MR000007. Epub 2016 Sep 6.

Department of Biostatistics, The University of Liverpool, Shelley's Cottage, Brownlow Street, Liverpool, UK, L69 3GS.

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http://dx.doi.org/10.1002/14651858.MR000007.pub3DOI Listing
September 2016

How to select outcome measurement instruments for outcomes included in a "Core Outcome Set" - a practical guideline.

Trials 2016 09 13;17(1):449. Epub 2016 Sep 13.

Department of Epidemiology and Biostatistics, EMGO Institute for Health and Care Research, VU University Medical Center, De Boelelaan 1089a, 1081 HV, Amsterdam, The Netherlands.

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http://dx.doi.org/10.1186/s13063-016-1555-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5020549PMC
September 2016

A patient and public involvement (PPI) toolkit for meaningful and flexible involvement in clinical trials - a work in progress.

Res Involv Engagem 2016 27;2:15. Epub 2016 Apr 27.

Department of Biostatistics, Clinical Trials Research Centre, Institute of Translational Medicine, University of Liverpool, Liverpool, L69 3BX UK.

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http://dx.doi.org/10.1186/s40900-016-0029-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5611579PMC
April 2016

TO THE EDITOR.

Spine (Phila Pa 1976) 2016 Mar;41(5):E301-2

*Division of Neurosurgery, Addenbrooke's Hospital & University of Cambridge, Cambridge, UK†MRC North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, Liverpool, UK‡Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Bristol, UK.

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http://dx.doi.org/10.1097/BRS.0000000000001410DOI Listing
March 2016

Improving the relevance and consistency of outcomes in comparative effectiveness research.

J Comp Eff Res 2016 Mar 1;5(2):193-205. Epub 2016 Mar 1.

Department of Biostatistics, University of Liverpool, Liverpool, UK.

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http://dx.doi.org/10.2217/cer-2015-0007DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4926524PMC
March 2016

The need for consensus, consistency, and core outcome sets in perioperative research.

Can J Anaesth 2016 Feb 10;63(2):133-7. Epub 2015 Dec 10.

Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology & Musculoskeletal Sciences, University of Oxford, Oxford, UK.

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http://dx.doi.org/10.1007/s12630-015-0529-2DOI Listing
February 2016

A Core Outcome Set for Evaluation of Interventions to Prevent Preterm Birth.

Obstet Gynecol 2016 Jan;127(1):49-58

Department of Obstetrics and Gynecology, Academic Medical Center, Amsterdam, the Netherlands; the Irish Neonatal Health Alliance, Wicklow, Ireland; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, MRC North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, and Liverpool Women's Hospital, Liverpool, and Imperial College Health Care NHS Trust, Queen Charlotte's and Chelsea Hospital, and the Women's Health Research Unit, the Blizard Institute, Barts and the London School of Medicine and Dentistry, London, United Kingdom; the George Washington University Biostatistics Center, Rockville, Maryland; the Department of Obstetrics and Gynecology, University of Texas Medical Branch Hospitals, Galveston, Texas; and the Department of Obstetrics and Gynaecology, the Robinson Research Institute, School of Paediatrics and Reproductive Health, University of Adelaide, Adelaide, Australia.

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http://dx.doi.org/10.1097/AOG.0000000000001195DOI Listing
January 2016

Core outcome sets and systematic reviews.

Syst Rev 2016 Jan 20;5:11. Epub 2016 Jan 20.

North West Hub for Trials Methodology Research, University of Liverpool, 1st floor Duncan Building, Daulby Street, Liverpool, L69 3GA, UK.

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http://dx.doi.org/10.1186/s13643-016-0188-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4719739PMC
January 2016

WITHDRAWN: Common antiepileptic drugs in pregnancy in women with epilepsy.

Cochrane Database Syst Rev 2015 Dec 17(12):CD004848. Epub 2015 Dec 17.

Department of Neurology, A5 Corridor, Walsgrave Hospital, University Hospitals Coventry and Warwickshire NHS Trust, Clifford Bridge Road, Coventry, Warwickshire, UK, CV2 2DX.

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http://dx.doi.org/10.1002/14651858.CD004848.pub2DOI Listing
December 2015

The COMET initiative database: progress and activities update (2014).

Trials 2015 Nov 11;16:515. Epub 2015 Nov 11.

Queens University Belfast, Institute of Clinical Sciences, Block B, Royal Hospitals, Grosvenor Road, Belfast, BT12 6BA, UK.

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http://dx.doi.org/10.1186/s13063-015-1038-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4642751PMC
November 2015

Consensus on the Need for a Hierarchical List of Patient-reported Pain Outcomes for Metaanalyses of Knee Osteoarthritis Trials: An OMERACT Objective.

J Rheumatol 2015 Oct 1;42(10):1971-1975. Epub 2015 May 1.

From the Musculoskeletal Statistics Unit, The Parker Institute, Department of Rheumatology, Copenhagen University Hospital; Bispebjerg and Frederiksberg, Denmark; Institute of Population Health, and Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada; Institute of Social and Preventive Medicine and Clinical Trials Unit Bern, Department of Clinical Research, University of Bern, Bern, Switzerland; Cochrane Collaboration, London; Department of Biostatistics, University of Liverpool, Liverpool, UK; departments of Epidemiology and Biostatistics, and Rheumatology, VU University Medical Center, Amsterdam, The Netherlands; Quintiles Inc.; Division of Rheumatology, Department of Medicine, Duke University School of Medicine, Durham, North Carolina, USA; Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, and Monash Department of Clinical Epidemiology, Cabrini Health, Melbourne; Northern Clinical School, Institute of Bone and Joint Research, University of Sydney, Department of Rheumatology, Sydney, Australia; Department of Epidemiology and Biostatistics and the EMGO Institute for Health and Care Research, VU University Medical Center Amsterdam, Amsterdam, The Netherlands; Birmingham Veterans Affairs (VA) Medical Center and University of Alabama at Birmingham, Birmingham, Alabama, USA.

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http://dx.doi.org/10.3899/jrheum.141384DOI Listing
October 2015

Multivariate meta-analysis helps examine the impact of outcome reporting bias in Cochrane rheumatoid arthritis reviews.

J Clin Epidemiol 2015 May 28;68(5):542-50. Epub 2014 Nov 28.

Department of Biostatistics, University of Liverpool, 1st Floor Duncan Building, Daulby Street, Liverpool, L69 3GA, United Kingdom.

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http://dx.doi.org/10.1016/j.jclinepi.2014.11.017DOI Listing
May 2015

RE: Recommended patient-reported core set of symptoms to measure in adult cancer treatment trials.

J Natl Cancer Inst 2015 Apr 6;107(4). Epub 2015 Feb 6.

Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, UK (BGM, NB, JMB); Department of Biostatistics, Institute of Translational Medicine, University of Liverpool, UK (PRW); Division of Surgery, Head and Neck, University Hospitals Bristol NHS Foundation Trust, UK (NB, JMB).

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http://dx.doi.org/10.1093/jnci/dju506DOI Listing
April 2015

Collating the knowledge base for core outcome set development: developing and appraising the search strategy for a systematic review.

BMC Med Res Methodol 2015 Mar 29;15:26. Epub 2015 Mar 29.

All Ireland Hub for Trials Methodology Research, Queen's University Belfast, Belfast, UK.

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http://dx.doi.org/10.1186/s12874-015-0019-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4395975PMC
March 2015

Sharing individual participant data from clinical trials: an opinion survey regarding the establishment of a central repository.

PLoS One 2014 29;9(5):e97886. Epub 2014 May 29.

North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, Liverpool, England.

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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0097886PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4038514PMC
January 2015

The natural history of conducting and reporting clinical trials: interviews with trialists.

Trials 2015 Jan 26;16:16. Epub 2015 Jan 26.

Centre for Medical Statistics and Health Evaluation, University of Liverpool, Liverpool, L69 3GS, UK.

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http://dx.doi.org/10.1186/s13063-014-0536-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4322554PMC
January 2015

The COMET Initiative database: progress and activities from 2011 to 2013.

Trials 2014 Jul 10;15:279. Epub 2014 Jul 10.

University of Liverpool, Department of Biostatistics, 1st floor Duncan Building, Daulby Street, Liverpool L69 3GA, UK.

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http://dx.doi.org/10.1186/1745-6215-15-279DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4107994PMC
July 2014

Time to 12-month remission and treatment failure for generalised and unclassified epilepsy.

J Neurol Neurosurg Psychiatry 2014 Jun 29;85(6):603-10. Epub 2013 Nov 29.

Department of Biostatistics, University of Liverpool, , Liverpool, UK.

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http://dx.doi.org/10.1136/jnnp-2013-306040DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4033033PMC
June 2014

Methodology of clinical trials for rare diseases.

Best Pract Res Clin Rheumatol 2014 Apr;28(2):247-62

Department of Women's and Children's Health, Institute of Translational Medicine, University of Liverpool, Liverpool, UK; Department of Paediatric Rheumatology, Alder Hey Children's NHS Foundation Trust, Liverpool, UK. Electronic address:

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http://dx.doi.org/10.1016/j.berh.2014.03.004DOI Listing
April 2014

The UK Lung Screen (UKLS): demographic profile of first 88,897 approaches provides recommendations for population screening.

Cancer Prev Res (Phila) 2014 Mar 17;7(3):362-71. Epub 2014 Jan 17.

Roy Castle Lung Cancer Research Programme, The University of Liverpool Cancer Research Centre, Department of Molecular and Clinical Cancer Medicine, Institute of Translational Medicine, The University of Liverpool, Roy Castle Building, 200 London Road, Liverpool L3 9TA, United Kingdom.

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http://dx.doi.org/10.1158/1940-6207.CAPR-13-0206DOI Listing
March 2014

A randomized trial of genotype-guided dosing of warfarin.

N Engl J Med 2013 Dec 19;369(24):2294-303. Epub 2013 Nov 19.

From the University of Liverpool (M.P., G.B., A.L.J., C.H.T., J.E.Z., P.R.W.) and Royal Liverpool and Broadgreen University Hospital National Health Service (NHS) Trust (M.P., C.H.T.), Liverpool, Whiston Hospital, Prescot (T.N.), and Newcastle upon Tyne NHS Trust (P.K.) and Newcastle University (J.B.L., A.K.D., P.A., F.K.), Newcastle upon Tyne - all in the United Kingdom; Uppsala University, Department of Medical Sciences (N.E., C.C., H.K., M.W.), Uppsala Clinical Research Center (N.E.) and Uppsala University Hospital (C.C., B.W., M.W.), Uppsala, and Enköping Hospital, Enköping (C.S.) - all in Sweden; and Utrecht University, Utrecht, the Netherlands (A.H.M.Z.).

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http://dx.doi.org/10.1056/NEJMoa1311386DOI Listing
December 2013