Rebecca L Mercieca-Bebber1, Alessandro Perreca2, Madeleine King3, Andrew Macann4, Katie Whale5, Salvatore Soldati2, Marc Jacobs6, Fabio Efficace2. 1. 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. 2. Data Center and Health Outcomes Research Unit, Italian Group for Adult Hematologic Diseases (GIMEMA), Via Benevento, 6, 00161 Rome, Italy. 3. 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. 4. Department of Radiation Oncology, Auckland Regional Cancer and Blood Service, Auckland City Hospital, 1023, New Zealand. 5. School of Social and Community Medicine, University of Bristol, Bristol, UK. 6. Academic Medical Center, University of Amsterdam, Department of Medical Psychology, Amsterdam, The Netherlands; Pharmerit International. Marten Meesweg 107, 3068 AV, Rotterdam, The Netherlands.
Abstract
AIM: 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.
AIM: 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: Rebecca Mercieca-Bebber; Julie Rouette; Melanie Calvert; Madeleine T King; Lori McLeod; Patricia Holch; Michael J Palmer; Michael Brundage Journal: Qual Life Res Date: 2017-02-07 Impact factor: 4.147
Authors: Matthew R LeBlanc; Rachel Hirschey; Ashley Leak Bryant; Thomas W LeBlanc; Sophia K Smith Journal: Qual Life Res Date: 2019-12-17 Impact factor: 4.147
Authors: Rebecca Mercieca-Bebber; Michael J Palmer; Michael Brundage; Melanie Calvert; Martin R Stockler; Madeleine T King Journal: BMJ Open Date: 2016-06-15 Impact factor: 2.692
Authors: Arnold Degboe; Sarah L Knight; Katarina Halling; Andrew Trigg; Tamara Al-Zubeidi; Natalie Aldhouse; Helen Kitchen; Lori Wirth; Simon N Rogers Journal: J Patient Rep Outcomes Date: 2018-08-01