SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials
出版年份 2021 全文链接
标题
SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials
作者
关键词
-
出版物
BMJ Open
Volume 11, Issue 6, Pages e045105
出版商
BMJ
发表日期
2021-07-01
DOI
10.1136/bmjopen-2020-045105
参考文献
相关参考文献
注意:仅列出部分参考文献,下载原文获取全部文献信息。- Quality of life assessment and reporting in colorectal cancer: A systematic review of phase III trials published between 2012 and 2018
- (2020) Pasquale Lombardi et al. CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY
- Moving beyond project-specific patient and public involvement in research
- (2020) Grace Turner et al. JOURNAL OF THE ROYAL SOCIETY OF MEDICINE
- International standards for the analysis of quality-of-life and patient-reported outcome endpoints in cancer randomised controlled trials: recommendations of the SISAQOL Consortium
- (2020) Corneel Coens et al. LANCET ONCOLOGY
- 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
- (2020) Madeleine T King et al. LANCET ONCOLOGY
- Maximising the impact of patient reported outcome assessment for patients and society
- (2019) Melanie Calvert et al. BMJ-British Medical Journal
- Quality of life assessment and reporting in prostate cancer: a systematic review of phase III trials testing anticancer drugs published between 2012 and 2018.
- (2019) Laura Marandino et al. Clinical Genitourinary Cancer
- Paediatric goal management training in patients with acquired brain injury: study protocol for a randomised controlled trial
- (2019) Ruth Elizabeth Hypher et al. BMJ Open
- The impact of patient-reported outcome (PRO) data from clinical trials: a systematic review and critical analysis
- (2019) Samantha Cruz Rivera et al. Health and Quality of Life Outcomes
- 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
- (2019) Mallorie H Fiero et al. LANCET ONCOLOGY
- Quality of life analysis in lung cancer: A systematic review of phase III trials published between 2012 and 2018
- (2019) Maria Lucia Reale et al. LUNG CANCER
- The Association of Proxy Care Engagement with Proxy Reports of Patient Experience and Quality of Life
- (2018) Jessica K. Roydhouse et al. HEALTH SERVICES RESEARCH
- Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols
- (2018) Melanie Calvert et al. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
- Quality of Life From Canadian Cancer Trials Group MA.17R: A Randomized Trial of Extending Adjuvant Letrozole to 10 Years
- (2018) Julie Lemieux et al. JOURNAL OF CLINICAL ONCOLOGY
- Incorporating the patient experience into regulatory decision making in the USA, Europe, and Canada
- (2018) Paul G Kluetz et al. LANCET ONCOLOGY
- Statistical analysis of patient-reported outcome data in randomised controlled trials of locally advanced and metastatic breast cancer: a systematic review
- (2018) Madeline Pe et al. LANCET ONCOLOGY
- Deficiencies in health-related quality-of-life assessment and reporting: a systematic review of oncology randomized phase III trials published between 2012 and 2016
- (2018) L Marandino et al. ANNALS OF ONCOLOGY
- Making a picture worth a thousand numbers: recommendations for graphically displaying patient-reported outcomes data
- (2018) Claire Snyder et al. QUALITY OF LIFE RESEARCH
- Use of an electronic patient-reported outcome measure in the management of patients with advanced chronic kidney disease: the RePROM pilot trial protocol
- (2018) Derek Kyte et al. BMJ Open
- Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration
- (2018) Karla Hemming et al. BMJ-British Medical Journal
- Guidelines for the Content of Statistical Analysis Plans in Clinical Trials
- (2017) Carrol Gamble et al. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
- Tofacitinib for Psoriatic Arthritis in Patients with an Inadequate Response to TNF Inhibitors
- (2017) Dafna Gladman et al. NEW ENGLAND JOURNAL OF MEDICINE
- Presenting comparative study PRO results to clinicians and researchers: beyond the eye of the beholder
- (2017) Michael Brundage et al. QUALITY OF LIFE RESEARCH
- Preliminary evidence on the uptake, use and benefits of the CONSORT-PRO extension
- (2017) Rebecca Mercieca-Bebber et al. QUALITY OF LIFE RESEARCH
- GRIPP2 reporting checklists: tools to improve reporting of patient and public involvement in research
- (2017) S Staniszewska et al. BMJ-British Medical Journal
- GRIPP2 reporting checklists: tools to improve reporting of patient and public involvement in research
- (2017) S Staniszewska et al. BMJ-British Medical Journal
- Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials: Symptomatic Adverse Events, Physical Function, and Disease-Related Symptoms
- (2016) P. G. Kluetz et al. CLINICAL CANCER RESEARCH
- Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials: a start in setting international standards
- (2016) Andrew Bottomley et al. LANCET ONCOLOGY
- Establishing the values for patient engagement (PE) in health-related quality of life (HRQoL) research: an international, multiple-stakeholder perspective
- (2016) Kirstie Haywood et al. QUALITY OF LIFE RESEARCH
- The patient-reported outcome content of international ovarian cancer randomised controlled trial protocols
- (2016) Rebecca Mercieca-Bebber et al. QUALITY OF LIFE RESEARCH
- Evaluating the effectiveness and cost-effectiveness of Dementia Care Mapping™ to enable person-centred care for people with dementia and their carers (DCM-EPIC) in care homes: study protocol for a randomised controlled trial
- (2016) Claire A. Surr et al. Trials
- How to select outcome measurement instruments for outcomes included in a “Core Outcome Set” – a practical guideline
- (2016) Cecilia A. C. Prinsen et al. Trials
- Current practices in patient-reported outcome (PRO) data collection in clinical trials: a cross-sectional survey of UK trial staff and management
- (2016) Derek Kyte et al. BMJ Open
- Design, implementation and reporting strategies to reduce the instance and impact of missing patient-reported outcome (PRO) data: a systematic review
- (2016) Rebecca Mercieca-Bebber et al. BMJ Open
- Management of Patient-Reported Outcome (PRO) Alerts in Clinical Trials: A Cross Sectional Survey.
- (2016) Derek Kyte et al. PLoS One
- Planning and reporting of quality-of-life outcomes in cancer trials
- (2015) S. Schandelmaier et al. ANNALS OF ONCOLOGY
- Quality of patient-reported outcome reporting across cancer randomized controlled trials according to the CONSORT patient-reported outcome extension: A pooled analysis of 557 trials
- (2015) Fabio Efficace et al. CANCER
- Putting patients at the heart of health-care research
- (2015) Melanie Calvert et al. LANCET
- Elotuzumab Therapy for Relapsed or Refractory Multiple Myeloma
- (2015) Sagar Lonial et al. NEW ENGLAND JOURNAL OF MEDICINE
- EAPC White Paper on outcome measurement in palliative care: Improving practice, attaining outcomes and delivering quality services – Recommendations from the European Association for Palliative Care (EAPC) Task Force on Outcome Measurement
- (2015) Claudia Bausewein et al. PALLIATIVE MEDICINE
- Mode of administration does not cause bias in patient-reported outcome results: a meta-analysis
- (2015) Claudia Rutherford et al. QUALITY OF LIFE RESEARCH
- Handling missing data in RCTs; a review of the top medical journals
- (2014) Melanie L Bell et al. BMC Medical Research Methodology
- The PCORI Perspective on Patient-Centered Outcomes Research
- (2014) Lori Frank et al. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
- Patient-Reported Outcome Results From the Open-Label Phase III AURELIA Trial Evaluating Bevacizumab-Containing Therapy for Platinum-Resistant Ovarian Cancer
- (2014) Martin R. Stockler et al. JOURNAL OF CLINICAL ONCOLOGY
- Multicenter Randomized Controlled Trial of Conventional Versus Laparoscopic Surgery for Colorectal Cancer Within an Enhanced Recovery Programme: EnROL
- (2014) Robin H. Kennedy et al. JOURNAL OF CLINICAL ONCOLOGY
- Bevacizumab Combined With Chemotherapy for Platinum-Resistant Recurrent Ovarian Cancer: The AURELIA Open-Label Randomized Phase III Trial
- (2014) Eric Pujade-Lauraine et al. JOURNAL OF CLINICAL ONCOLOGY
- Reducing waste from incomplete or unusable reports of biomedical research
- (2014) Paul Glasziou et al. LANCET
- Increasing value and reducing waste in research design, conduct, and analysis
- (2014) John P A Ioannidis et al. LANCET
- Idelalisib and Rituximab in Relapsed Chronic Lymphocytic Leukemia
- (2014) Richard R. Furman et al. NEW ENGLAND JOURNAL OF MEDICINE
- Systematic Evaluation of the Patient-Reported Outcome (PRO) Content of Clinical Trial Protocols
- (2014) Derek Kyte et al. PLoS One
- Patient-Reported Outcome (PRO) Assessment in Clinical Trials: A Systematic Review of Guidance for Trial Protocol Writers
- (2014) Melanie Calvert et al. PLoS One
- Pooling of cross-cultural PRO data in multinational clinical trials: How much can poor measurement affect statistical power?
- (2014) Antoine Regnault et al. QUALITY OF LIFE RESEARCH
- Using quantitative methods within the Universalist model framework to explore the cross-cultural equivalence of patient-reported outcome instruments
- (2014) Antoine Regnault et al. QUALITY OF LIFE RESEARCH
- The chronic autoimmune thyroiditis quality of life selenium trial (CATALYST): study protocol for a randomized controlled trial
- (2014) Kristian Winther et al. Trials
- PRO Data Collection in Clinical Trials Using Mixed Modes: Report of the ISPOR PRO Mixed Modes Good Research Practices Task Force
- (2014) Sonya Eremenco et al. VALUE IN HEALTH
- Clinical Trials: Discerning Hype From Substance
- (2013) Thomas R. Fleming ANNALS OF INTERNAL MEDICINE
- SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials
- (2013) An-Wen Chan et al. ANNALS OF INTERNAL MEDICINE
- Early surgery versus optimal current step-up practice for chronic pancreatitis (ESCAPE): design and rationale of a randomized trial
- (2013) Usama Ahmed Ali et al. BMC GASTROENTEROLOGY
- Incomplete Data in Randomized Dermatology Trials: Consequences and Statistical Methodology
- (2013) Michael A. McIsaac et al. DERMATOLOGY
- Patient-Reported Outcome Alerts
- (2013) Derek Kyte et al. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
- Reporting of Patient-Reported Outcomes in Randomized Trials
- (2013) Melanie Calvert et al. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
- Randomized Phase III Study of Erlotinib Versus Observation in Patients With No Evidence of Disease Progression After First-Line Platin-Based Chemotherapy for Ovarian Carcinoma: A European Organisation for Research and Treatment of Cancer-Gynaecological Cancer Group, and Gynecologic Cancer Intergroup Study
- (2013) Ignace B. Vergote et al. JOURNAL OF CLINICAL ONCOLOGY
- The Selection and Use of Outcome Measures in Palliative and End-of-Life Care Research: The MORECare International Consensus Workshop
- (2013) Catherine J. Evans et al. JOURNAL OF PAIN AND SYMPTOM MANAGEMENT
- Inconsistencies in Quality of Life Data Collection in Clinical Trials: A Potential Source of Bias? Interviews with Research Nurses and Trialists
- (2013) Derek Kyte et al. PLoS One
- ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research
- (2013) Bryce B. Reeve et al. QUALITY OF LIFE RESEARCH
- SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials
- (2013) A.-W. Chan et al. BMJ-British Medical Journal
- 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
- (2012) Fiona J Collinson et al. BMC CANCER
- The design and conduct of clinical trials to limit missing data
- (2012) R. J. Little et al. STATISTICS IN MEDICINE
- SCOPE1: a randomised phase II/III multicentre clinical trial of definitive chemoradiation, with or without cetuximab, in carcinoma of the oesophagus
- (2011) Christopher N Hurt et al. BMC CANCER
- Imputation by the mean score should be avoided when validating a Patient Reported Outcomes questionnaire by a Rasch model in presence of informative missing data
- (2011) Jean-Benoit Hardouin et al. BMC Medical Research Methodology
- Developing a Valid Patient-Reported Outcome Measure
- (2011) N E Rothrock et al. CLINICAL PHARMACOLOGY & THERAPEUTICS
- Clinician-trialist rounds: 5. Cointervention bias – how to diagnose it in their trial and prevent it in yours
- (2011) David L Sackett Clinical Trials
- Carboplatin Plus Paclitaxel Versus Carboplatin Plus Pegylated Liposomal Doxorubicin As First-Line Treatment for Patients With Ovarian Cancer: The MITO-2 Randomized Phase III Trial
- (2011) Sandro Pignata et al. JOURNAL OF CLINICAL ONCOLOGY
- Assessing Agreement Between Terminally Ill Cancer Patients’ Reports of Their Quality of Life and Family Caregiver and Palliative Care Physician Proxy Ratings
- (2011) Jennifer M. Jones et al. JOURNAL OF PAIN AND SYMPTOM MANAGEMENT
- Psychological morbidity and quality of life of ethnic minority patients with cancer: a systematic review and meta-analysis
- (2011) Tim Luckett et al. LANCET ONCOLOGY
- Content Validity—Establishing and Reporting the Evidence in Newly Developed Patient-Reported Outcomes (PRO) Instruments for Medical Product Evaluation: ISPOR PRO Good Research Practices Task Force Report: Part 2—Assessing Respondent Understanding
- (2011) Donald L. Patrick et al. VALUE IN HEALTH
- Content Validity—Establishing and Reporting the Evidence in Newly Developed Patient-Reported Outcomes (PRO) Instruments for Medical Product Evaluation: ISPOR PRO Good Research Practices Task Force Report: Part 1—Eliciting Concepts for a New PRO Instrument
- (2011) Donald L. Patrick et al. VALUE IN HEALTH
- Cosmesis and body image after single-port laparoscopic or conventional laparoscopic cholecystectomy: a multicenter double blinded randomised controlled trial (SPOCC-trial)
- (2011) Daniel C Steinemann et al. BMC Surgery
- A point of minimal important difference (MID): a critique of terminology and methods
- (2011) Madeleine T King Expert Review of Pharmacoeconomics & Outcomes Research
- Study protocol of the YOU CALL - WE CALL TRIAL: impact of a multimodal support intervention after a "mild" stroke
- (2010) Annie Rochette et al. BMC Neurology
- Guidance for Developers of Health Research Reporting Guidelines
- (2010) David Moher et al. PLOS MEDICINE
- Dangers in Using Translated Medical Questionnaires
- (2009) Raoul Breugelmans CHEST
- How Do Proxy Responses and Proxy-Assisted Responses Differ from What Medicare Beneficiaries Might Have Reported about Their Health Care?
- (2008) Marc N. Elliott et al. HEALTH SERVICES RESEARCH
- Survival End Point Reporting in Randomized Cancer Clinical Trials: A Review of Major Journals
- (2008) Simone Mathoulin-Pelissier et al. JOURNAL OF CLINICAL ONCOLOGY
- Consistency of Phase III Clinical Trial Abstracts Presented at an Annual Meeting of the American Society of Clinical Oncology Compared With Their Subsequent Full-Text Publications
- (2008) Vincent C. Tam et al. JOURNAL OF CLINICAL ONCOLOGY
- Development of EMPRO: A Tool for the Standardized Assessment of Patient-Reported Outcome Measures
- (2008) Jose M. Valderas et al. VALUE IN HEALTH
- Multinational Trials—Recommendations on the Translations Required, Approaches to Using the Same Language in Different Countries, and the Approaches to Support Pooling the Data: The ISPOR Patient-Reported Outcomes Translation and Linguistic Validation Good Research Practices Task Force Report
- (2008) Diane Wild et al. VALUE IN HEALTH
- Recommendations on Evidence Needed to Support Measurement Equivalence between Electronic and Paper-Based Patient-Reported Outcome (PRO) Measures: ISPOR ePRO Good Research Practices Task Force Report
- (2008) Stephen Joel Coons et al. VALUE IN HEALTH
- Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes
- (2007) Dennis Revicki et al. JOURNAL OF CLINICAL EPIDEMIOLOGY
Add your recorded webinar
Do you already have a recorded webinar? Grow your audience and get more views by easily listing your recording on Peeref.
Upload NowAsk a Question. Answer a Question.
Quickly pose questions to the entire community. Debate answers and get clarity on the most important issues facing researchers.
Get Started