{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,24]],"date-time":"2026-10-24T04:45:51Z","timestamp":1792817151372,"version":"4.5.0"},"reference-count":141,"publisher":"BMJ","issue":"6","license":[{"start":{"date-parts":[[2021,6,30]],"date-time":"2021-06-30T00:00:00Z","timestamp":1625011200000},"content-version":"unspecified","delay-in-days":29,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2021,1,8]]},"published-print":{"date-parts":[[2021,6]]},"abstract":"<jats:p>Patient-reported outcomes (PROs) are used in clinical trials to provide valuable evidence on the impact of disease and treatment on patients\u2019 symptoms, function and quality of life. High-quality PRO data from trials can inform shared decision-making, regulatory and economic analyses and health policy. Recent evidence suggests the PRO content of past trial protocols was often incomplete or unclear, leading to research waste. To address this issue, international, consensus-based, PRO-specific guidelines were developed: the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)-PRO Extension. The SPIRIT-PRO Extension is a 16-item checklist which aims to improve the content and quality of aspects of clinical trial protocols relating to PRO data collection to minimise research waste, and ultimately better inform patient-centred care. This SPIRIT-PRO explanation and elaboration (E&amp;E) paper provides information to promote understanding and facilitate uptake of the recommended checklist items, including a comprehensive protocol template. For each SPIRIT-PRO item, we provide a detailed description, one or more examples from existing trial protocols and supporting empirical evidence of the item\u2019s importance. We recommend this paper and protocol template be used alongside the SPIRIT 2013 and SPIRIT-PRO Extension paper to optimise the transparent development and review of trial protocols with PROs.<\/jats:p>","DOI":"10.1136\/bmjopen-2020-045105","type":"journal-article","created":{"date-parts":[[2021,6,30]],"date-time":"2021-06-30T12:36:18Z","timestamp":1625056578000},"page":"e045105","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":128,"title":["SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials"],"prefix":"10.1136","volume":"11","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1856-837X","authenticated-orcid":false,"given":"Melanie","family":"Calvert","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Madeleine","family":"King","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3708-9099","authenticated-orcid":false,"given":"Rebecca","family":"Mercieca-Bebber","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olalekan","family":"Aiyegbusi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Derek","family":"Kyte","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anita","family":"Slade","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"An-Wen","family":"Chan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"E","family":"Basch","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jill","family":"Bell","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonia","family":"Bennett","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vishal","family":"Bhatnagar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3354-3330","authenticated-orcid":false,"given":"Jane","family":"Blazeby","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew","family":"Bottomley","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julia","family":"Brown","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Brundage","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lisa","family":"Campbell","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph C","family":"Cappelleri","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heather","family":"Draper","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amylou C","family":"Dueck","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carolyn","family":"Ells","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lori","family":"Frank","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert M","family":"Golub","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ingolf","family":"Griebsch","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kirstie","family":"Haywood","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2156-7279","authenticated-orcid":false,"given":"Amanda","family":"Hunn","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bellinda","family":"King-Kallimanis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura","family":"Martin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandra","family":"Mitchell","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Morel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Linda","family":"Nelson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Josephine","family":"Norquist","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"O'Connor","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Palmer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Donald","family":"Patrick","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gary","family":"Price","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antoine","family":"Regnault","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ameeta","family":"Retzer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dennis","family":"Revicki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jane","family":"Scott","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard","family":"Stephens","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9783-9413","authenticated-orcid":false,"given":"Grace","family":"Turner","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonia","family":"Valakas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Galina","family":"Velikova","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"von Hildebrand","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anita","family":"Walker","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lari","family":"Wenzel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2021,6,30]]},"reference":[{"key":"2024112411563022000_11.6.e045105.1","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-158-3-201302050-00583"},{"key":"2024112411563022000_11.6.e045105.2","doi-asserted-by":"crossref","DOI":"10.1136\/bmj.e7586","article-title":"Spirit 2013 explanation and elaboration: guidance for protocols of clinical trials","volume":"346","author":"Chan","year":"2013","journal-title":"BMJ"},{"key":"2024112411563022000_11.6.e045105.3","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0110229","article-title":"Systematic evaluation of the patient-reported outcome (pro) content of clinical trial protocols","volume":"9","author":"Kyte","year":"2014","journal-title":"PLoS One"},{"key":"2024112411563022000_11.6.e045105.4","doi-asserted-by":"crossref","first-page":"2457","DOI":"10.1007\/s11136-016-1339-x","article-title":"The patient-reported outcome content of international ovarian cancer randomised controlled trial protocols","volume":"25","author":"Mercieca-Bebber","year":"2016","journal-title":"Qual Life Res"},{"key":"2024112411563022000_11.6.e045105.5","first-page":"1170","volume-title":"Systematic evaluation of patient-reported outcome protocol content and reporting in cancer trials","volume":"111","author":"Kyte","year":"2019"},{"key":"2024112411563022000_11.6.e045105.6","doi-asserted-by":"crossref","DOI":"10.1136\/bmjopen-2016-012281","article-title":"Current practices in patient-reported outcome (pro) data collection in clinical trials: a cross-sectional survey of UK trial staff and management","volume":"6","author":"Kyte","year":"2016","journal-title":"BMJ Open"},{"key":"2024112411563022000_11.6.e045105.7","doi-asserted-by":"crossref","first-page":"5","DOI":"10.1186\/s41687-017-0008-3","article-title":"A systematic evaluation of compliance and reporting of patient-reported outcome endpoints in ovarian cancer randomised controlled trials: implications for generalisability and clinical practice","volume":"1","author":"Mercieca-Bebber","year":"2017","journal-title":"J Patient Rep Outcomes"},{"key":"2024112411563022000_11.6.e045105.8","doi-asserted-by":"crossref","first-page":"156","DOI":"10.1186\/s12955-019-1220-z","article-title":"The impact of patient-reported outcome (pro) data from clinical trials: a systematic review and critical analysis","volume":"17","author":"Rivera","year":"2019","journal-title":"Health Qual Life Outcomes"},{"key":"2024112411563022000_11.6.e045105.9","first-page":"55","article-title":"Systematic evaluation of patient-reported outcome (pro) protocol content and reporting in cancer clinical trials: the EPIC study","volume":"26","author":"Kyte","year":"2017","journal-title":"Quality of Life Research"},{"key":"2024112411563022000_11.6.e045105.10","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2017.21903"},{"key":"2024112411563022000_11.6.e045105.11","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0076625","article-title":"Inconsistencies in quality of life data collection in clinical trials: a potential source of bias? interviews with research nurses and Trialists","volume":"8","author":"Kyte","year":"2013","journal-title":"PLoS One"},{"key":"2024112411563022000_11.6.e045105.12","doi-asserted-by":"crossref","first-page":"23","DOI":"10.1016\/j.conctc.2017.11.009","article-title":"The administration of patient-reported outcome questionnaires in cancer trials: interviews with trial coordinators regarding their roles, experiences, challenges and training","volume":"9","author":"Mercieca-Bebber","year":"2018","journal-title":"Contemp Clin Trials Commun"},{"key":"2024112411563022000_11.6.e045105.13","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pmed.1000217","article-title":"Guidance for developers of health research reporting guidelines","volume":"7","author":"Moher","year":"2010","journal-title":"PLoS Med"},{"key":"2024112411563022000_11.6.e045105.14","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0110216","article-title":"Patient-Reported outcome (pro) assessment in clinical trials: a systematic review of guidance for trial protocol writers","volume":"9","author":"Calvert","year":"2014","journal-title":"PLoS One"},{"key":"2024112411563022000_11.6.e045105.15","unstructured":"Rivera S , Stephens R , Mercieca-Bebber R . \u201cGive Us The Tools!\u201d - Development of knowledge transfer tools to support the involvement of patient partners in clinical trial protocol development with patient-reported outcomes, in accordance with SPIRIT-PRO guideline. BMJ. Under review."},{"key":"2024112411563022000_11.6.e045105.16","unstructured":"FDA . Guidance for industry, patient-reported outcome measures: use in medical product development to Suport labeling claims, 2009. Available: https:\/\/www.fda.gov\/media\/77832\/download [Accessed 25 Nov 2019]."},{"key":"2024112411563022000_11.6.e045105.17","unstructured":"FDA-NIH Biomarker Working Group . Best (biomarkers, endpoints, and other tools) resource, 2016. Available: https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK326791\/"},{"key":"2024112411563022000_11.6.e045105.18","unstructured":"Curtis LHA , Weinfurt K . Choosing and specifying endpoints and outcomes: introduction. in: rethinking clinical trials: a living textbook of pragmatic clinical trials, 2019."},{"key":"2024112411563022000_11.6.e045105.19","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2013.879"},{"key":"2024112411563022000_11.6.e045105.20","doi-asserted-by":"crossref","first-page":"67","DOI":"10.1200\/EDBK_159514","article-title":"Patient-Reported Outcomes in Cancer Clinical Trials: Measuring Symptomatic Adverse Events With the National Cancer Institute\u2019s Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)","volume":"35","author":"Kluetz","year":"2016","journal-title":"Am Soc Clin Oncol Educ Book"},{"key":"2024112411563022000_11.6.e045105.21","unstructured":"ClinicalTrials.gov . Glossary of common site terms, 2020. Available: https:\/\/clinicaltrials.gov\/ct2\/about-studies\/glossary [Accessed 12 Mar 2020]."},{"key":"2024112411563022000_11.6.e045105.22","unstructured":"FDA . Drug Development Tool Glossary [updated 08\/15\/2017], 2020. Available: https:\/\/www.fda.gov\/drugs\/drug-development-tool-ddt-qualification-programs\/ddt-glossary [Accessed 03 Jul 2020]."},{"key":"2024112411563022000_11.6.e045105.23","doi-asserted-by":"publisher","DOI":"10.1016\/S0959-8049(96)00412-1"},{"key":"2024112411563022000_11.6.e045105.24","doi-asserted-by":"crossref","DOI":"10.1136\/bmj.c869","article-title":"Consort 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials","volume":"340","author":"Moher","year":"2010","journal-title":"BMJ"},{"key":"2024112411563022000_11.6.e045105.25","doi-asserted-by":"crossref","first-page":"k1614","DOI":"10.1136\/bmj.k1614","article-title":"Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration","volume":"14","author":"Hemming","year":"2018","journal-title":"BMJ"},{"key":"2024112411563022000_11.6.e045105.26","unstructured":"SPIRIT-Statement, 2020. Available: https:\/\/www.spirit-statement.org\/ [Accessed 27 Apr 2020]."},{"key":"2024112411563022000_11.6.e045105.27","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2013.54.3694"},{"key":"2024112411563022000_11.6.e045105.28","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.j3453"},{"key":"2024112411563022000_11.6.e045105.29","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1315226"},{"key":"2024112411563022000_11.6.e045105.30","doi-asserted-by":"crossref","DOI":"10.1136\/bmjopen-2015-010938","article-title":"Design, implementation and reporting strategies to reduce the instance and impact of missing patient-reported outcome (pro) data: a systematic review","volume":"6","author":"Mercieca-Bebber","year":"2016","journal-title":"BMJ Open"},{"key":"2024112411563022000_11.6.e045105.31","unstructured":"Trog 11.03 a randomised phase III trial of high dose palliative radiotherapy (HDPRT) versus concurrent chemotherapy + HDPRT (C-HDPRT) in patients with good performance status, locally Advanced\/Small volume metastatic non small cell lung cancer (NSCLC) not suitable for radical chemo-radiotherapy (P_LUNG GP), 2012. Available: https:\/\/www.anzctr.org.au\/Trial\/Registration\/TrialReview.aspx?id=363229&showOriginal=true&isReview=true [Accessed 05 Dec 2019]."},{"key":"2024112411563022000_11.6.e045105.32","unstructured":"RATE-AF trial protocol. Available: https:\/\/www.birmingham.ac.uk\/research\/activity\/mds\/trials\/bctu\/trials\/portfolio-v\/RateAF\/index.aspx [Accessed 21 Nov 2019]."},{"key":"2024112411563022000_11.6.e045105.33","unstructured":"EMA . Ich E9 (R1) addendum on estimands and sensitivity analysis in clinical trials, 2019. Available: https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/ich-e9-r1-addendum-estimands-sensitivity-analysis-clinical-trials-guideline-statistical-principles_en.pdf"},{"key":"2024112411563022000_11.6.e045105.34","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(19)30790-9"},{"key":"2024112411563022000_11.6.e045105.35","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-153-6-201009210-00008"},{"key":"2024112411563022000_11.6.e045105.36","doi-asserted-by":"crossref","first-page":"e459","DOI":"10.1016\/S1470-2045(18)30418-2","article-title":"Statistical analysis of patient-reported outcome data in randomised controlled trials of locally advanced and metastatic breast cancer: a systematic review","volume":"19","author":"Pe","year":"2018","journal-title":"Lancet Oncol"},{"key":"2024112411563022000_11.6.e045105.37","doi-asserted-by":"crossref","first-page":"e582","DOI":"10.1016\/S1470-2045(19)30335-3","article-title":"Us food and drug administration review of statistical analysis of patient-reported outcomes in lung cancer clinical trials Approved between January, 2008, and December, 2017","volume":"20","author":"Fiero","year":"2019","journal-title":"Lancet Oncol"},{"key":"2024112411563022000_11.6.e045105.38","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(16)30510-1"},{"key":"2024112411563022000_11.6.e045105.39","unstructured":"SWOG-9208 Quality of Life and Health Status in Patients With Stage I or Stage II Hodgkin\u2019s Disease. Available: https:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT00002563 [Accessed 25 Nov 2019]."},{"key":"2024112411563022000_11.6.e045105.40","doi-asserted-by":"publisher","DOI":"10.1097\/00005650-199810000-00009"},{"key":"2024112411563022000_11.6.e045105.41","doi-asserted-by":"crossref","DOI":"10.1136\/bmj.d1828","article-title":"Reporting of eligibility criteria of randomised trials: cohort study comparing trial protocols with subsequent articles","volume":"342","author":"Bl\u00fcmle","year":"2011","journal-title":"BMJ"},{"key":"2024112411563022000_11.6.e045105.42","doi-asserted-by":"crossref","first-page":"1073","DOI":"10.1016\/S0140-6736(15)60599-2","article-title":"Putting patients at the heart of health-care research","volume":"385","author":"Calvert","year":"2015","journal-title":"The Lancet"},{"key":"2024112411563022000_11.6.e045105.43","unstructured":"EMA . Appendix 2 to the Guideline on the evaluation of anticancer medicinal products in man. The use of patient-reported outcome (pro) measures in oncology studies, 2016. Available: https:\/\/www.ema.europa.eu\/en\/documents\/other\/appendix-2-guideline-evaluation-anticancer-medicinal-products-man_en.pdf"},{"key":"2024112411563022000_11.6.e045105.44","doi-asserted-by":"publisher","DOI":"10.1001\/jama.1995.03520250075037"},{"key":"2024112411563022000_11.6.e045105.45","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-15-2035"},{"key":"2024112411563022000_11.6.e045105.46","doi-asserted-by":"crossref","first-page":"S106","DOI":"10.1111\/j.1524-4733.2007.00273.x","article-title":"Analysis and interpretation of results based on patient-reported outcomes","volume":"10(Suppl 2)","author":"Sloan","year":"2007","journal-title":"Value Health"},{"key":"2024112411563022000_11.6.e045105.47","doi-asserted-by":"crossref","DOI":"10.1186\/1745-6215-15-115","article-title":"The chronic autoimmune thyroiditis quality of life selenium trial (catalyst): study protocol for a randomized controlled trial","volume":"15","author":"Winther","year":"2014","journal-title":"Trials"},{"key":"2024112411563022000_11.6.e045105.48","doi-asserted-by":"crossref","DOI":"10.1186\/1471-2482-11-24","article-title":"Cosmesis and body image after single-port laparoscopic or conventional laparoscopic cholecystectomy: a multicenter double blinded randomised controlled trial (SPOCC-trial)","volume":"11","author":"Steinemann","year":"2011","journal-title":"BMC Surg"},{"key":"2024112411563022000_11.6.e045105.49","doi-asserted-by":"crossref","first-page":"685","DOI":"10.1016\/S1470-2045(20)30085-1","article-title":"Quality of life after breast-conserving therapy and adjuvant radiotherapy for non-low-risk ductal carcinoma in situ (big 3-07\/TROG 07.01): 2-year results of a randomised, controlled, phase 3 trial","volume":"21","author":"King","year":"2020","journal-title":"Lancet Oncol"},{"key":"2024112411563022000_11.6.e045105.50","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2007.03.012"},{"key":"2024112411563022000_11.6.e045105.51","doi-asserted-by":"publisher","DOI":"10.1586\/erp.11.9"},{"key":"2024112411563022000_11.6.e045105.52","doi-asserted-by":"crossref","first-page":"273","DOI":"10.1007\/s11136-014-0765-x","article-title":"Pooling of cross-cultural PRO data in multinational clinical trials: how much can poor measurement affect statistical power?","volume":"24","author":"Regnault","year":"2015","journal-title":"Qual Life Res"},{"key":"2024112411563022000_11.6.e045105.53","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2377-10-3"},{"key":"2024112411563022000_11.6.e045105.54","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2407-11-466"},{"key":"2024112411563022000_11.6.e045105.55","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(18)30097-4"},{"key":"2024112411563022000_11.6.e045105.56","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.k5267"},{"key":"2024112411563022000_11.6.e045105.57","unstructured":"Comet initiative. Available: http:\/\/www.comet-initiative.org\/"},{"key":"2024112411563022000_11.6.e045105.58","doi-asserted-by":"crossref","first-page":"S125","DOI":"10.1111\/j.1524-4733.2007.00275.x","article-title":"Patient-Reported outcomes to support medical product labeling claims: FDA perspective","volume":"10(Suppl 2)","author":"Patrick","year":"2007","journal-title":"Value Health"},{"key":"2024112411563022000_11.6.e045105.59","doi-asserted-by":"publisher","DOI":"10.1016\/j.jval.2011.06.014"},{"key":"2024112411563022000_11.6.e045105.60","doi-asserted-by":"publisher","DOI":"10.1016\/j.jval.2011.06.013"},{"key":"2024112411563022000_11.6.e045105.61","doi-asserted-by":"publisher","DOI":"10.1007\/s11136-012-0344-y"},{"key":"2024112411563022000_11.6.e045105.62","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-016-1555-2"},{"key":"2024112411563022000_11.6.e045105.63","doi-asserted-by":"publisher","DOI":"10.1111\/j.1524-4733.2007.00309.x"},{"key":"2024112411563022000_11.6.e045105.64","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.2011.195"},{"key":"2024112411563022000_11.6.e045105.65","doi-asserted-by":"crossref","first-page":"353","DOI":"10.2147\/PROM.S156279","article-title":"The importance of patient-reported outcomes in clinical trials and strategies for future optimization","volume":"9","author":"Mercieca-Bebber","year":"2018","journal-title":"Patient Relat Outcome Meas"},{"key":"2024112411563022000_11.6.e045105.66","doi-asserted-by":"crossref","DOI":"10.1186\/1471-230X-13-49","article-title":"Early surgery versus optimal current step-up practice for chronic pancreatitis (escape): design and rationale of a randomized trial","volume":"13","author":"Ahmed Ali","year":"2013","journal-title":"BMC Gastroenterol"},{"key":"2024112411563022000_11.6.e045105.67","doi-asserted-by":"crossref","DOI":"10.1186\/1471-2407-12-598","article-title":"The StAR trial protocol: a randomised multi-stage phase II\/III study of sunitinib comparing temporary cessation with allowing continuation, at the time of maximal radiological response, in the first-line treatment of locally advanced\/metastatic renal cancer","volume":"12","author":"Collinson","year":"2012","journal-title":"BMC Cancer"},{"key":"2024112411563022000_11.6.e045105.68","unstructured":"Standard vs modified drug therapy (StAR), 2015. Available: https:\/\/njl-admin.nihr.ac.uk\/document\/download\/2024304 [Accessed 03 Mar 2020]."},{"key":"2024112411563022000_11.6.e045105.69","unstructured":"FDA . Methods to Identify What is Important to Patients & Select, Develop or Modify Fit-for-Purpose Clinical Outcomes Assessments, 2018. Available: https:\/\/www.fda.gov\/drugs\/news-events-human-drugs\/patient-focused-drug-development-guidance-methods-identify-what-important-patients-and-select"},{"key":"2024112411563022000_11.6.e045105.70","doi-asserted-by":"crossref","first-page":"559","DOI":"10.1007\/s11136-015-1110-8","article-title":"Mode of administration does not cause bias in patient-reported outcome results: a meta-analysis","volume":"25","author":"Rutherford","year":"2016","journal-title":"Qual Life Res"},{"key":"2024112411563022000_11.6.e045105.71","doi-asserted-by":"publisher","DOI":"10.1111\/j.1524-4733.2008.00470.x"},{"key":"2024112411563022000_11.6.e045105.72","doi-asserted-by":"publisher","DOI":"10.1016\/j.jval.2014.06.005"},{"key":"2024112411563022000_11.6.e045105.73","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1505654"},{"key":"2024112411563022000_11.6.e045105.74","doi-asserted-by":"publisher","DOI":"10.1111\/j.1524-4733.2005.04054.x"},{"key":"2024112411563022000_11.6.e045105.75","doi-asserted-by":"publisher","DOI":"10.1111\/j.1524-4733.2008.00471.x"},{"key":"2024112411563022000_11.6.e045105.76","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(11)70212-1"},{"key":"2024112411563022000_11.6.e045105.77","unstructured":"Slade A , Retzer A , Ahmed K . Systematic review of the use of translated patient reported outcome measures in cancer trials. Submitted, under review."},{"key":"2024112411563022000_11.6.e045105.78","unstructured":"Eortc translation procedure manual. Available: https:\/\/www.eortc.org\/app\/uploads\/sites\/2\/2018\/02\/translation_manual_2017.pdf [Accessed 25 Nov 2019]."},{"key":"2024112411563022000_11.6.e045105.79","doi-asserted-by":"publisher","DOI":"10.1023\/A:1026410721664"},{"key":"2024112411563022000_11.6.e045105.80","doi-asserted-by":"publisher","DOI":"10.1023\/A:1008846618880"},{"key":"2024112411563022000_11.6.e045105.81","doi-asserted-by":"publisher","DOI":"10.1378\/chest.09-1684"},{"key":"2024112411563022000_11.6.e045105.82","doi-asserted-by":"crossref","first-page":"37","DOI":"10.1097\/01.mlr.0000103529.63132.77","article-title":"Assessing and adjusting for cross-cultural validity of impairment and activity limitation scales through differential item functioning within the framework of the Rasch model","volume":"42","author":"Tennant","year":"2004","journal-title":"Med Care"},{"key":"2024112411563022000_11.6.e045105.83","doi-asserted-by":"crossref","first-page":"115","DOI":"10.1007\/s11136-014-0722-8","article-title":"Using quantitative methods within the Universalist model framework to explore the cross-cultural equivalence of patient-reported outcome instruments","volume":"24","author":"Regnault","year":"2015","journal-title":"Qual Life Res"},{"key":"2024112411563022000_11.6.e045105.84","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2019-029273"},{"key":"2024112411563022000_11.6.e045105.85","doi-asserted-by":"crossref","DOI":"10.1186\/s13063-016-1416-z","article-title":"Evaluating the effectiveness and cost-effectiveness of dementia care Mapping\u2122 to enable person-centred care for people with dementia and their carers (DCM-EPIC) in care homes: study protocol for a randomised controlled trial","volume":"17","author":"Surr","year":"2016","journal-title":"Trials"},{"key":"2024112411563022000_11.6.e045105.86","doi-asserted-by":"publisher","DOI":"10.1177\/0269216315589898"},{"key":"2024112411563022000_11.6.e045105.87","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpainsymman.2013.01.010"},{"key":"2024112411563022000_11.6.e045105.88","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpainsymman.2010.11.018"},{"key":"2024112411563022000_11.6.e045105.89","doi-asserted-by":"publisher","DOI":"10.1111\/j.1475-6773.2007.00820.x"},{"key":"2024112411563022000_11.6.e045105.90","doi-asserted-by":"crossref","first-page":"33","DOI":"10.2147\/PROM.S126919","article-title":"Patient-rated versus proxy-rated cognitive and functional measures in older adults","volume":"8","author":"Howland","year":"2017","journal-title":"Patient Relat Outcome Meas"},{"key":"2024112411563022000_11.6.e045105.91","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpainsymman.2013.01.010"},{"key":"2024112411563022000_11.6.e045105.92","doi-asserted-by":"crossref","first-page":"3809","DOI":"10.1111\/1475-6773.12980","article-title":"The association of proxy care engagement with proxy reports of patient experience and quality of life","volume":"53","author":"Roydhouse","year":"2018","journal-title":"Health Serv Res"},{"key":"2024112411563022000_11.6.e045105.93","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2010.33.8566"},{"key":"2024112411563022000_11.6.e045105.94","doi-asserted-by":"crossref","first-page":"563","DOI":"10.1200\/JCO.2017.75.7500","article-title":"Quality of life from Canadian cancer trials Group MA.17R: a randomized trial of extending adjuvant letrozole to 10 years","volume":"36","author":"Lemieux","year":"2018","journal-title":"J Clin Oncol"},{"key":"2024112411563022000_11.6.e045105.95","doi-asserted-by":"crossref","first-page":"95","DOI":"10.1177\/1740774517741113","article-title":"A systematic review and development of a classification framework for factors associated with missing patient-reported outcome data","volume":"15","author":"Palmer","year":"2018","journal-title":"Clinical Trials"},{"key":"2024112411563022000_11.6.e045105.96","doi-asserted-by":"publisher","DOI":"10.1002\/(SICI)1097-0258(19980315\/15)17:5\/7<781::AID-SIM821>3.0.CO;2-O"},{"key":"2024112411563022000_11.6.e045105.97","doi-asserted-by":"publisher","DOI":"10.1002\/(SICI)1097-0258(19980315\/15)17:5\/7<667::AID-SIM813>3.0.CO;2-6"},{"key":"2024112411563022000_11.6.e045105.98","doi-asserted-by":"crossref","DOI":"10.1186\/1471-2288-14-118","article-title":"Handling missing data in RCTs; a review of the top medical journals","volume":"14","author":"Bell","year":"2014","journal-title":"BMC Med Res Methodol"},{"key":"2024112411563022000_11.6.e045105.99","unstructured":"FDA . FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency 2020 [updated 21\/09\/2020], 2020. Available: https:\/\/www.fda.gov\/media\/136238\/download [Accessed 22 Oct 2020]."},{"key":"2024112411563022000_11.6.e045105.100","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2013.51.4489"},{"key":"2024112411563022000_11.6.e045105.101","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2013.51.4240"},{"key":"2024112411563022000_11.6.e045105.102","doi-asserted-by":"crossref","unstructured":"Fairclough DL . Design and analysis of quality of life studies in clinical trials. CRC Press, 2010.","DOI":"10.1201\/9781420061185"},{"key":"2024112411563022000_11.6.e045105.103","doi-asserted-by":"crossref","first-page":"1525","DOI":"10.1056\/NEJMoa1615977","article-title":"Tofacitinib for psoriatic arthritis in patients with an inadequate response to TNF inhibitors","volume":"377","author":"Gladman","year":"2017","journal-title":"N Engl J Med"},{"key":"2024112411563022000_11.6.e045105.104","doi-asserted-by":"publisher","DOI":"10.1093\/jnci\/85.5.365"},{"key":"2024112411563022000_11.6.e045105.105","unstructured":"FDA . Multiple endpoints in clinical trials. Guidance for industry, 2017. Available: https:\/\/www.fda.gov\/media\/102657\/download [Accessed 19 Mar 2020]."},{"key":"2024112411563022000_11.6.e045105.106","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2013.50.5669"},{"key":"2024112411563022000_11.6.e045105.107","doi-asserted-by":"publisher","DOI":"10.1007\/BF00433916"},{"key":"2024112411563022000_11.6.e045105.108","unstructured":"Fayers P , Aaronson N , Bjordal K . Bottomley a, on behalf of the EORTC quality of life group: the EORTC QLQ\u2013C30 scoring manual. 3rd edn, 2001."},{"key":"2024112411563022000_11.6.e045105.109","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2288-11-105"},{"key":"2024112411563022000_11.6.e045105.110","doi-asserted-by":"publisher","DOI":"10.1002\/sim.5519"},{"key":"2024112411563022000_11.6.e045105.111","doi-asserted-by":"publisher","DOI":"10.1159\/000346247"},{"key":"2024112411563022000_11.6.e045105.112","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2017.18556"},{"key":"2024112411563022000_11.6.e045105.113","first-page":"1","article-title":"How much missing data is too much? Monte Carlo simulations to develop SISAQOL guidelines for missing data handling","author":"Mazza","year":"2018"},{"key":"2024112411563022000_11.6.e045105.114","doi-asserted-by":"crossref","DOI":"10.1136\/bmjopen-2018-026080","article-title":"Use of an electronic patient-reported outcome measure in the management of patients with advanced chronic kidney disease: the RePROM pilot trial protocol","volume":"8","author":"Kyte","year":"2018","journal-title":"BMJ Open"},{"key":"2024112411563022000_11.6.e045105.115","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2013.277222"},{"key":"2024112411563022000_11.6.e045105.116","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0144658","article-title":"Management of patient-reported outcome (pro) alerts in clinical trials: a cross sectional survey","volume":"11","author":"Kyte","year":"2016","journal-title":"PLoS One"},{"key":"2024112411563022000_11.6.e045105.117","doi-asserted-by":"publisher","DOI":"10.1177\/1740774511410995"},{"key":"2024112411563022000_11.6.e045105.118","unstructured":"European Parliament, Council of the European Union . Regulation (EU) 2016\/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing directive 95\/46\/EC (General data protection regulation), 2016."},{"key":"2024112411563022000_11.6.e045105.119","unstructured":"Calvert M , Kyte D , Mercieca-Bebber R . Supplement 3 - Summary Recommendations for Inclusion of PRO-Specific Information in the Trial Protocol, Supplementary Documents for Training for Staff, 2018. Available: https:\/\/jamanetwork.com\/journals\/jama\/fullarticle\/2671472"},{"key":"2024112411563022000_11.6.e045105.120","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdv283"},{"key":"2024112411563022000_11.6.e045105.121","doi-asserted-by":"publisher","DOI":"10.1002\/cncr.29489"},{"key":"2024112411563022000_11.6.e045105.122","doi-asserted-by":"crossref","first-page":"1427","DOI":"10.1007\/s11136-017-1508-6","article-title":"Preliminary evidence on the uptake, use and benefits of the CONSORT-PRO extension","volume":"26","author":"Mercieca-Bebber","year":"2017","journal-title":"Qual Life Res"},{"key":"2024112411563022000_11.6.e045105.123","doi-asserted-by":"crossref","first-page":"2288","DOI":"10.1093\/annonc\/mdy449","article-title":"Deficiencies in health-related quality-of-life assessment and reporting: a systematic review of oncology randomized phase III trials published between 2012 and 2016","volume":"29","author":"Marandino","year":"2018","journal-title":"Ann Oncol"},{"key":"2024112411563022000_11.6.e045105.124","doi-asserted-by":"crossref","DOI":"10.1016\/j.critrevonc.2020.102877","article-title":"Quality of life assessment and reporting in colorectal cancer: a systematic review of phase III trials published between 2012 and 2018","volume":"146","author":"Lombardi","year":"2020","journal-title":"Crit Rev Oncol Hematol"},{"key":"2024112411563022000_11.6.e045105.125","doi-asserted-by":"crossref","first-page":"332","DOI":"10.1016\/j.clgc.2019.07.007","article-title":"Quality-Of-Life assessment and reporting in prostate cancer: systematic review of phase 3 trials testing anticancer drugs published between 2012 and 2018","volume":"17","author":"Marandino","year":"2019","journal-title":"Clin Genitourin Cancer"},{"key":"2024112411563022000_11.6.e045105.126","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2007.14.1192"},{"key":"2024112411563022000_11.6.e045105.127","doi-asserted-by":"crossref","first-page":"47","DOI":"10.1016\/j.lungcan.2019.10.022","article-title":"Quality of life analysis in lung cancer: a systematic review of phase III trials published between 2012 and 2018","volume":"139","author":"Reale","year":"2020","journal-title":"Lung Cancer"},{"key":"2024112411563022000_11.6.e045105.128","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2007.14.6795"},{"key":"2024112411563022000_11.6.e045105.129","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(13)62227-8"},{"key":"2024112411563022000_11.6.e045105.130","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(13)62228-X"},{"key":"2024112411563022000_11.6.e045105.131","unstructured":"European Commission . Clinical trials regulations (EU) NO 536\/2014, 2019. Available: https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-10\/regulation5362014_qa_en.pdf [Accessed 19 Mar 2020]."},{"key":"2024112411563022000_11.6.e045105.132","unstructured":"EU Clinical Trials . Summaries of Clinical Trial Results for Laypersons 2018 [Recommendations of the expert group on clinical trials for the implementation of Regulation (EU) No 536\/2014 on clinical trials on medicinal products for human use]. Available: https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-10\/2017_01_26_summaries_of_ct_results_for_laypersons.pdf [Accessed 03 May 2020]."},{"key":"2024112411563022000_11.6.e045105.133","unstructured":"FDA . CDER patient-focused drug development, 2019. Available: https:\/\/www.fda.gov\/drugs\/development-approval-process-drugs\/cder-patient-focused-drug-development [Accessed 23 Apr 2020]."},{"key":"2024112411563022000_11.6.e045105.134","doi-asserted-by":"crossref","first-page":"16","DOI":"10.1177\/0141076819890551","article-title":"Moving beyond project-specific patient and public involvement in research","volume":"113","author":"Turner","year":"2020","journal-title":"J R Soc Med"},{"key":"2024112411563022000_11.6.e045105.135","doi-asserted-by":"publisher","DOI":"10.1007\/s11136-018-2020-3"},{"key":"2024112411563022000_11.6.e045105.136","doi-asserted-by":"crossref","first-page":"1848","DOI":"10.1002\/cncr.30530","article-title":"What do these scores mean? Presenting patient-reported outcomes data to patients and clinicians to improve interpretability","volume":"123","author":"Snyder","year":"2017","journal-title":"Cancer"},{"key":"2024112411563022000_11.6.e045105.137","doi-asserted-by":"publisher","DOI":"10.1007\/s11136-017-1710-6"},{"key":"2024112411563022000_11.6.e045105.138","doi-asserted-by":"crossref","first-page":"1393","DOI":"10.1007\/s11136-016-1465-5","article-title":"Establishing the values for patient engagement (PE) in health-related quality of life (HRQoL) research: an international, multiple-stakeholder perspective","volume":"26","author":"Haywood","year":"2017","journal-title":"Qual Life Res"},{"key":"2024112411563022000_11.6.e045105.139","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2014.11100"},{"key":"2024112411563022000_11.6.e045105.140","unstructured":"Supremo useful links. Available: https:\/\/www.supremo-trial.com\/useful-links.asp [Accessed 19 Mar 2020]."},{"key":"2024112411563022000_11.6.e045105.141","doi-asserted-by":"crossref","first-page":"S59","DOI":"10.1111\/j.1524-4733.2007.00267.x","article-title":"The Mayo clinic manuscript series relative to the discussion, Dissemination, and operationalization of the food and drug administration guidance on patient-reported outcomes","volume":"10(Suppl 2)","author":"Sloan","year":"2007","journal-title":"Value Health"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2020-045105","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,11,24]],"date-time":"2024-11-24T14:59:23Z","timestamp":1732460363000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2020-045105"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,6]]},"references-count":141,"journal-issue":{"issue":"6","published-online":{"date-parts":[[2021,6,30]]},"published-print":{"date-parts":[[2021,6]]}},"alternative-id":["10.1136\/bmjopen-2020-045105"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2020-045105","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,6]]}}}