SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials

Calvert, Melanie; King, Madeleine; Mercieca-Bebber, Rebecca; Aiyegbusi, Olalekan; Kyte, Derek; Slade, Anita; Chan, An-Wen; Basch, E; Bell, Jill; Bennett, Antonia; Bhatnagar, Vishal; Blazeby, Jane; Bottomley, Andrew; Brown, Julia; Brundage, Michael; Campbell, Lisa; Cappelleri, Joseph C; Draper, Heather; Dueck, Amylou C; Ells, Carolyn; Frank, Lori; Golub, Robert M; Griebsch, Ingolf; Haywood, Kirstie; Hunn, Amanda; King-Kallimanis, Bellinda; Martin, Laura; Mitchell, Sandra; Morel, Thomas; Nelson, Linda; Norquist, Josephine; O'Connor, Daniel; Palmer, Michael; Patrick, Donald; Price, Gary; Regnault, Antoine; Retzer, Ameeta; Revicki, Dennis; Scott, Jane; Stephens, Richard; Turner, Grace; Valakas, Antonia; Velikova, Galina; von Hildebrand, Maria; Walker, Anita; Wenzel, Lari

Patient-reported outcomes (PROs) are used in clinical trials to provide valuable evidence on the impact of disease and treatment on patients’ symptoms, function and quality of life. High-quality PRO data from trials can inform shared decision-making, regulatory and economic analyses and health policy. Recent evidence suggests the PRO content of past trial protocols was often incomplete or unclear, leading to research waste. To address this issue, international, consensus-based, PRO-specific guidelines were developed: the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)-PRO Extension. The SPIRIT-PRO Extension is a 16-item checklist which aims to improve the content and quality of aspects of clinical trial protocols relating to PRO data collection to minimise research waste, and ultimately better inform patient-centred care. This SPIRIT-PRO explanation and elaboration (E&E) paper provides information to promote understanding and facilitate uptake of the recommended checklist items, including a comprehensive protocol template. For each SPIRIT-PRO item, we provide a detailed description, one or more examples from existing trial protocols and supporting empirical evidence of the item’s importance. We recommend this paper and protocol template be used alongside the SPIRIT 2013 and SPIRIT-PRO Extension paper to optimise the transparent development and review of trial protocols with PROs.