SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials
21 September 2021
Patient Reported Outcomes (PROs) can 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 clinical care, regulatory decisions and health policy. However, problems such as poor data collection, analysis, reporting and interpretation often reduce or negate their value. This paper attempts to raise standards by enhancing the international SPRIT-PRO guidelines that were created to optimise the design of clinical trials and encourage the consistent, high-quality reporting of PROs and ultimately to inform patient-centred care.
The PRO content of past trial protocols has often been incomplete or unclear leading to research waste. An appraisal of the PRO content of >350 past trial protocols showed that many lacked the specific information needed for high-quality PRO data collection and evidence generation. As a result this may lead to poor quality or non-reporting of PRO trial results, which may hinder the potential for PRO evidence to be used in regulatory decision-making, health policy and clinical care
The SPIRIT-PRO guidance and the subsequent SPIRIT-PRO Extension (a 16-item checklist intended to improve the content and quality of aspects of clinical trial protocols relating to PRO data collection) were created to establish standards to improve the content and quality of trial protocols. However, further work is required to support uptake and implementation.
A team led by Melanie Calvert, NIHR Senior Investigator, Professor of Outcomes Methodology at the University of Birmingham and Director of Centre for Patient Reported Outcomes Research and Professor Madeleine King, University of Sydney, have developed tools to support the use of SPIRIT-PRO by researchers to generate high quality PRO data to inform patient care. This includes a protocol template, detailed descriptions and examples of good practice.
Impact and outcomes
While trial protocols are the foundation for study planning, conduct, reporting and appraisal, they vary greatly in content and quality. By providing specific recommendations about PRO endpoints it is possible to improve the situation – providing valuable information for clinicians and patients about the risks, benefits and tolerability of an intervention.
The work carried out by Prof. Calvert, Prof. King, Dr Olalekan Aiyegbusi with international collaborators (supported by UCB Pharma, Macmillan Cancer Support, the NIHR and HDR UK) has the potential to dramatically improve the quality and value of PRO data gathering and reporting in clinical trials. This in turn has far-reaching implications for care – allowing patients and their care teams to understand how an intervention will affect someone, whether it is appropriate or if an alternative should be considered.
Patient and Public Involvement and Engagement
Patient partners were involved in the design, conduct, reporting and dissemination plans of the research. This included the development of the SPIRIT-PRO Extension, the paper, protocol template, tools to support implementation by patient partners. Patient partners are included as co-authors.
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Prof. Calvert: email@example.com
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