title: Patient-reported outcomes in head and neck and thyroid cancer randomised controlled trials: A systematic review of completeness of reporting and impact on interpretation.
abstract: OBJECTIVE
  To determine the completeness of reporting of patient-reported outcomes (PROs) of head and neck cancer (HNC) and thyroid cancer randomised-controlled trials (RCTs) and identify PRO measures used.
  
  
  METHODS
  A systematic literature search was conducted for HNC and thyroid cancer RCTs with PRO end-points (January 2004-June 2015). Two investigators independently extracted data, assessed adherence to the International Society for Quality of Life Research (ISOQOL) PRO reporting standards and concordance between hypotheses and PRO measures used. Data were entered into the Patient-Reported Outcomes Measurements Over Time in Oncology (PROMOTION) Registry.
  
  
  RESULTS
  Sixty-six RCTs were included, 56 (85%) HNC and 10 (15%) thyroid cancer. Twenty-two (33%) included a primary and 44 (67%) included a secondary PRO end-point. A total of 40 unique PRO measures were used. Adherence to the ISOQOL PRO reporting standards was higher for RCTs with primary PRO end-points than for secondary PRO end-points: (mean adherence of 43% and 29% respectively). Completeness of PRO reporting did not improve with time: r = .13, p = .31. ISOQOL checklist items poorly reported included: PRO hypothesis (reported for eight RCTs, 12%), justification chosen of PRO measures (n = 16, 24%), rates of missing PRO data (n = 19, 29%), and generalisability of results (n = 12, 18%). Encouragingly, PROs were identified in 55 RCT abstracts (83%) and PRO results interpreted for 30 RCTs (45%).
  
  
  CONCLUSIONS
  Reporting of PRO end-points was more comprehensive in RCTs with primary rather than secondary PRO end-points. Improvement is needed in the transparent reporting of PRO studies, particularly regarding data collection, analyses and generalisability of PRO results.
authors: Central Clinical School, Sydney Medical School, University of Sydney, NSW 2006, Australia; Psycho-oncology Co-operative Research Group, School of Psychology, University of Sydney. Level 6 North, Chris O'Brien Lifehouse C39Z, University of Sydney, NSW 2006, Australia. Electronic address: Rebecca.Mercieca@sydney.edu.au.
authors: Rebecca L
authors: RL
authors: Mercieca-Bebber
authors: Data Center and Health Outcomes Research Unit, Italian Group for Adult Hematologic Diseases (GIMEMA), Via Benevento, 6, 00161 Rome, Italy.
authors: Alessandro
authors: A
authors: Perreca
authors: Central Clinical School, Sydney Medical School, University of Sydney, NSW 2006, Australia; Psycho-oncology Co-operative Research Group, School of Psychology, University of Sydney. Level 6 North, Chris O'Brien Lifehouse C39Z, University of Sydney, NSW 2006, Australia.
authors: Madeleine
authors: M
authors: King
authors: Department of Radiation Oncology, Auckland Regional Cancer and Blood Service, Auckland City Hospital, 1023, New Zealand.
authors: Andrew
authors: A
authors: Macann
authors: School of Social and Community Medicine, University of Bristol, Bristol, UK.
authors: Katie
authors: K
authors: Whale
authors: Data Center and Health Outcomes Research Unit, Italian Group for Adult Hematologic Diseases (GIMEMA), Via Benevento, 6, 00161 Rome, Italy.
authors: Salvatore
authors: S
authors: Soldati
authors: Academic Medical Center, University of Amsterdam, Department of Medical Psychology, Amsterdam, The Netherlands; Pharmerit International. Marten Meesweg 107, 3068 AV, Rotterdam, The Netherlands.
authors: Marc
authors: M
authors: Jacobs
authors: Data Center and Health Outcomes Research Unit, Italian Group for Adult Hematologic Diseases (GIMEMA), Via Benevento, 6, 00161 Rome, Italy.
authors: Fabio
authors: F
authors: Efficace
mesh_terms: D057189:Checklist; D023381:Endpoint Determination; D006258:Head and Neck Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D006801:Humans; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D057566:Self Report; D013964:Thyroid Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D013997:Time Factors; D016896:Treatment Outcome
keywords: Data Reporting; Head and Neck Neoplasms; Patient-reported outcome; Quality of Life [I01.800]; Systematic Review; Thyroid Neoplasms