Time trends in health-related quality of life assessment and reporting within publications of oncology randomised phase III trials: a meta-research study
Raimondo Di Liello,
Massimo Di Maio,
Francesco Perrone,
Fabio Turco,
Alessandro Rossi,
Piera Gargiulo,
Andrea Caglio,
Valentina Tuninetti,
Eleonora Ghisoni,
Laura Marandino,
Federica Trastu,
Pasquale Lombardi,
Annapaola Mariniello,
Maria Lucia Reale,
Giacomo Aimar,
Marco Audisio,
Maristella Bungaro,
Teresa Gamba,
Chiara Paratore
Affiliations
Raimondo Di Liello
Clinical Trial Unit, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Italy
Massimo Di Maio
Department of Oncology, University of Turin, AOU Città della Salute e della Scienza di Torino, Torino, Italy
Francesco Perrone
Clinical Trial Unit, Istituto Nazionale Tumori Istituto di Ricovero e Cura a Carattere Scientifico Fondazione Pascale, Naples, Italy
Fabio Turco
Department of Oncology, University of Turin, at San Luigi Gonzaga Hospital, Orbassano, Italy
Alessandro Rossi
Department of Clinical and Molecular Medicine, “La Sapienza” University of Rome, at Azienda Ospedaliera Sant’Andrea, Rome, Italy
Piera Gargiulo
Clinical Trial Unit, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Italy
Andrea Caglio
Department of Oncology, University of Turin, at Ordine Mauriziano Hospital, Torino, Italy
Valentina Tuninetti
Department of Oncology, University of Turin, at Ordine Mauriziano Hospital, Torino, Italy
Eleonora Ghisoni
Department of Oncology, Ludwig Institute for Cancer Research, Lausanne, Switzerland
Laura Marandino
Department of Medical Oncology, IRCCS Ospedale San Raffaele, Milano, Italy
Federica Trastu
Department of Oncology, University of Turin, at Ordine Mauriziano Hospital, Torino, Italy
Pasquale Lombardi
Phase I Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy
Annapaola Mariniello
Emory Vaccine Center, Emory University School of Medicine, Atlanta, Georgia, USA
Maria Lucia Reale
Department of Oncology, University of Turin, at San Luigi Gonzaga Hospital, Orbassano, Italy
Giacomo Aimar
Department of Oncology, University of Turin, at Santa Croce e Carle Hospital, Cuneo, Italy
Marco Audisio
Department of Oncology, University of Turin, at San Luigi Gonzaga Hospital, Orbassano, Italy
Maristella Bungaro
Department of Oncology, University of Turin, at San Luigi Gonzaga Hospital, Orbassano, Italy
Teresa Gamba
Department of Oncology, University of Turin, at Ordine Mauriziano Hospital, Torino, Italy
Chiara Paratore
Department of Oncology, University of Turin, at San Luigi Gonzaga Hospital, Orbassano, Italy
Objective To assess time trends in the inclusion of health-related quality of life (QoL) among study endpoints and in the reporting of QoL results in study publications, randomised phase III oncology trials published between 2017 and 2021 were compared with the trials published in the previous 5 years.Methods and analysis All issues published between 2012 and 2021 by 11 major journals were handsearched for primary publications of phase III trials in adult patients with solid tumours. Trials published in 2017–2021 were compared with trials published in 2012–2016 for three endpoints: (1) proportion of publications including QoL among endpoints out of all the eligible publications; (2) proportion of publications presenting QoL results out of those including QoL among endpoints and (3) proportion of publications presenting QoL data out of all the eligible publications.Results 388 publications between 2017 and 2021 were eligible and compared with 446 publications between 2012 and 2016. QoL was included among endpoints in 67.8% of trials in 2017–2021 vs 52.9% in 2012–2016 (univariate OR 1.87, 95% CI 1.41 to 2.48, p<0.001). QoL results were available in 52.1% in 2017–2021 vs 62.3% in 2012–2016 of primary publications of trials including QoL among endpoints (OR 0.66, 95% CI 0.46 to 0.94, p=0.02). Overall, QoL was analysed and presented in 35.3% of primary publications in 2017–2021 vs 33.0% in 2012–2016 (OR 1.11, 95% CI 0.83 to 1.48, p=0.48).Conclusions The proportion of oncology trials including QoL among endpoints increased in 2017–2021 compared with 2012–2016. However, the proportion of primary publications reporting QoL results remains suboptimal.
