Rebecca Mercieca-Bebber1,2, Michael Friedlander3,4, Peey-Sei Kok3,4, Melanie Calvert5, Derek Kyte5, Martin Stockler3, Madeleine T King6,7,4. 1. Central Clinical School, Sydney Medical School, University of Sydney, Sydney, NSW, 2006, Australia. Rebecca.mercieca@sydney.edu.au. 2. Quality of Life Office, Psycho-oncology Co-operative Research Group, School of Psychology, University of Sydney, Level 6 North, Chris O'Brien Lifehouse C39Z, Sydney, NSW, 2006, Australia. Rebecca.mercieca@sydney.edu.au. 3. NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, 2006, Australia. 4. Australian New Zealand Gynecological Oncology Group (ANZGOG), Camperdown, NSW, 2050, Australia. 5. Institute of Applied Health Research, University of Birmingham, Birmingham, UK. 6. Central Clinical School, Sydney Medical School, University of Sydney, Sydney, NSW, 2006, Australia. 7. Quality of Life Office, Psycho-oncology Co-operative Research Group, School of Psychology, University of Sydney, Level 6 North, Chris O'Brien Lifehouse C39Z, Sydney, NSW, 2006, Australia.
Abstract
PURPOSE: Patient-reported outcomes (PROs) provide the patient's perspective of the impact of treatment. Evidence suggests that PRO content of randomised controlled trials (RCTs) protocols is generally sub-optimal. This study aimed to describe and evaluate the PRO-specific content of ovarian cancer RCT protocols. METHODS: Published, phase III, ovarian cancer RCTs with PRO endpoints were identified following a systematic search of Medline and Cochrane databases (Jan 2000 to Feb 2016). Corresponding RCT protocols were downloaded (if published) or obtained by contacting authors. Two investigators independently assessed adherence of PRO-specific content of included protocols to a checklist of 58 recommended PRO protocol items currently being developed by the International Society for Quality of Life Research. Discrepancies were resolved with a third investigator. RESULTS: Of 41 eligible trials identified, 26 protocols were assessed (developed 1995-2010). We were unable to obtain the remaining 15 protocols. Protocols addressed a mean of 28 % PRO checklist items (range 8-66 %). Fifteen (58 % of assessed protocols) provided a rationale for PRO assessment, 8 (31 %) described a PRO objective, 24 (92 %) included a PRO assessment schedule, but only 6 (23 %) justified timing of PRO assessments. Twelve protocols (46 %) provided staff data collection instructions, 4 (15 %) included plans for monitoring PRO compliance, and 16 (62 %) included a PRO analysis plan. CONCLUSIONS: On average, protocols addressed less than one-third of PRO protocol checklist items. In some cases, key guidance regarding PRO administration was lacking, which may lead to inconsistent and sub-optimal PRO methodology. Efforts are needed to improve PRO protocol content in cancer trials.
PURPOSE:Patient-reported outcomes (PROs) provide the patient's perspective of the impact of treatment. Evidence suggests that PRO content of randomised controlled trials (RCTs) protocols is generally sub-optimal. This study aimed to describe and evaluate the PRO-specific content of ovarian cancer RCT protocols. METHODS: Published, phase III, ovarian cancer RCTs with PRO endpoints were identified following a systematic search of Medline and Cochrane databases (Jan 2000 to Feb 2016). Corresponding RCT protocols were downloaded (if published) or obtained by contacting authors. Two investigators independently assessed adherence of PRO-specific content of included protocols to a checklist of 58 recommended PRO protocol items currently being developed by the International Society for Quality of Life Research. Discrepancies were resolved with a third investigator. RESULTS: Of 41 eligible trials identified, 26 protocols were assessed (developed 1995-2010). We were unable to obtain the remaining 15 protocols. Protocols addressed a mean of 28 % PRO checklist items (range 8-66 %). Fifteen (58 % of assessed protocols) provided a rationale for PRO assessment, 8 (31 %) described a PRO objective, 24 (92 %) included a PRO assessment schedule, but only 6 (23 %) justified timing of PRO assessments. Twelve protocols (46 %) provided staff data collection instructions, 4 (15 %) included plans for monitoring PRO compliance, and 16 (62 %) included a PRO analysis plan. CONCLUSIONS: On average, protocols addressed less than one-third of PRO protocol checklist items. In some cases, key guidance regarding PRO administration was lacking, which may lead to inconsistent and sub-optimal PRO methodology. Efforts are needed to improve PRO protocol content in cancer trials.
Entities:
Keywords:
Clinical trials as topic; Guideline adherence; Ovarian cancer; Patient-reported outcomes; Protocol checklist; Quality of life
Authors: An-Wen Chan; Jennifer M Tetzlaff; Peter C Gøtzsche; Douglas G Altman; Howard Mann; Jesse A Berlin; Kay Dickersin; Asbjørn Hróbjartsson; Kenneth F Schulz; Wendy R Parulekar; Karmela Krleza-Jeric; Andreas Laupacis; David Moher Journal: BMJ Date: 2013-01-08
Authors: Derek Kyte; Bryce B Reeve; Fabio Efficace; Kirstie Haywood; Rebecca Mercieca-Bebber; Madeleine T King; Josephine M Norquist; William R Lenderking; Claire Snyder; Lena Ring; Galina Velikova; Melanie Calvert Journal: Qual Life Res Date: 2015-08-15 Impact factor: 4.147
Authors: Paul Glasziou; Douglas G Altman; Patrick Bossuyt; Isabelle Boutron; Mike Clarke; Steven Julious; Susan Michie; David Moher; Elizabeth Wager Journal: Lancet Date: 2014-01-08 Impact factor: 79.321
Authors: An-Wen Chan; Jennifer M Tetzlaff; Douglas G Altman; Andreas Laupacis; Peter C Gøtzsche; Karmela Krleža-Jerić; Asbjørn Hróbjartsson; Howard Mann; Kay Dickersin; Jesse A Berlin; Caroline J Doré; Wendy R Parulekar; William S M Summerskill; Trish Groves; Kenneth F Schulz; Harold C Sox; Frank W Rockhold; Drummond Rennie; David Moher Journal: Ann Intern Med Date: 2013-02-05 Impact factor: 25.391
Authors: Melanie Calvert; Derek Kyte; Helen Duffy; Adrian Gheorghe; Rebecca Mercieca-Bebber; Jonathan Ives; Heather Draper; Michael Brundage; Jane Blazeby; Madeleine King Journal: PLoS One Date: 2014-10-15 Impact factor: 3.240
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: Melanie Calvert; Madeleine King; Rebecca Mercieca-Bebber; Olalekan Aiyegbusi; Derek Kyte; Anita Slade; An-Wen Chan; E Basch; Jill Bell; Antonia Bennett; Vishal Bhatnagar; Jane Blazeby; Andrew Bottomley; Julia Brown; Michael Brundage; Lisa Campbell; Joseph C Cappelleri; Heather Draper; Amylou C Dueck; Carolyn Ells; Lori Frank; Robert M Golub; Ingolf Griebsch; Kirstie Haywood; Amanda Hunn; Bellinda King-Kallimanis; Laura Martin; Sandra Mitchell; Thomas Morel; Linda Nelson; Josephine Norquist; Daniel O'Connor; Michael Palmer; Donald Patrick; Gary Price; Antoine Regnault; Ameeta Retzer; Dennis Revicki; Jane Scott; Richard Stephens; Grace Turner; Antonia Valakas; Galina Velikova; Maria von Hildebrand; Anita Walker; Lari Wenzel Journal: BMJ Open Date: 2021-06-30 Impact factor: 2.692
Authors: Ameeta Retzer; Thomas Keeley; Khaled Ahmed; Jo Armes; Julia M Brown; Lynn Calman; Chris Copland; Fabio Efficace; Anna Gavin; Adam Glaser; Diana M Greenfield; Anne Lanceley; Rachel M Taylor; Galina Velikova; Michael Brundage; Rebecca Mercieca-Bebber; Madeleine T King; Melanie Calvert; Derek Kyte Journal: BMJ Open Date: 2018-02-03 Impact factor: 2.692
Authors: Houssein Safa; Monica Tamil; Philippe E Spiess; Brandon Manley; Julio Pow-Sang; Scott M Gilbert; Firas Safa; Brian D Gonzalez; Laura B Oswald; Adele Semaan; Adi Diab; Jad Chahoud Journal: J Natl Cancer Inst Date: 2021-05-04 Impact factor: 13.506