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Calvert, M., King, M., Mercieca-bebber, R., Aiyegbusi,, O.L., Kyte, Derek 
ORCID: https://orcid.org/0000-0002-7679-6741, Slade, A., Chan, A.W., Basch, E., Bell, J.A., Bennett, A.V., Bhatnagar, V., Blazeby, J., Bottomley, A., Brown, J., Campbell, L., Cappelleri, J.C., Draper, H., Dueck, A., Ells, C., Frank, L., Golub, R.M., Griebsch, I., Hayward, K., Hunn, A., King-Kallimanis, B.L., Martin, L., Mitchell, S., Morel, T., Nelson, L., Norquist, J.M., O'Connor, D., Palmer, M.J., Patrick, D., Price, G., Regnault, A., Retzer, A., Revicki, D., Scott, J., Stephens, R., Turner, G., Valakas, A., Velikova, G., Von Hildebrand,, M., Walker, A. and Wenzel, L.
(2021)
SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials.
BMJ Open, 11 (6).
e045105..
ISSN Online: 2044-6055
Abstract
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.
| Item Type: | Article |
|---|---|
| Additional Information: | This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. The full-text of the published article can be accessed via the Official URL. |
| Uncontrolled Discrete Keywords: | SPIRIT-PRO, Patient-reported outcomes |
| Divisions: | College of Health, Life and Environmental Sciences > School of Allied Health and Community |
| Related URLs: | |
| Copyright Info: | Open Access article |
| Depositing User: | Derek Kyte |
| Date Deposited: | 27 Aug 2021 08:22 |
| Last Modified: | 27 Aug 2021 08:22 |
| URI: | https://eprints.worc.ac.uk/id/eprint/11304 |
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