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      Patient-Reported Outcomes (PROs) and Patient-Reported Outcome Measures (PROMs)

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          Abstract

          In recent years, there has been an increased focus on placing patients at the center of health care research and evaluating clinical care in order to improve their experience and ensure that research is both robust and of maximum value for the use of medicinal products, therapy, or health services. This paper provides an overview of patients’ involvement in clinical research and service evaluation along with its benefits and limitations. We describe and discuss patient-reported outcomes (PROs) and patient-reported outcome measures (PROMs), including the trends in current research. Both the patient-reported experiences measures (PREMs) and patient and public involvement (PPI) initiative for including patients in the research processes are also outlined. PROs provide reports from patients about their own health, quality of life, or functional status associated with the health care or treatment they have received. PROMs are tools and/or instruments used to report PROs. Patient report experiences through the use of PREMs, such as satisfaction scales, providing insight into the patients’ experience with their care or a health service. There is increasing international attention regarding the use of PREMS as a quality indicator of patient care and safety. This reflects the ongoing health service commitment of involving patients and the public within the wider context of the development and evaluation of health care service delivery and quality improvement.

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          Most cited references35

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          Cochrane Handbook for Systematic Reviews of Interventions

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            Increasing response rates to postal questionnaires: systematic review.

            To identify methods to increase response to postal questionnaires. Systematic review of randomised controlled trials of any method to influence response to postal questionnaires. 292 randomised controlled trials including 258 315 participants INTERVENTION REVIEWED: 75 strategies for influencing response to postal questionnaires. The proportion of completed or partially completed questionnaires returned. The odds of response were more than doubled when a monetary incentive was used (odds ratio 2.02; 95% confidence interval 1.79 to 2.27) and almost doubled when incentives were not conditional on response (1.71; 1.29 to 2.26). Response was more likely when short questionnaires were used (1.86; 1.55 to 2.24). Personalised questionnaires and letters increased response (1.16; 1.06 to 1.28), as did the use of coloured ink (1.39; 1.16 to 1.67). The odds of response were more than doubled when the questionnaires were sent by recorded delivery (2.21; 1.51 to 3.25) and increased when stamped return envelopes were used (1.26; 1.13 to 1.41) and questionnaires were sent by first class post (1.12; 1.02 to 1.23). Contacting participants before sending questionnaires increased response (1.54; 1.24 to 1.92), as did follow up contact (1.44; 1.22 to 1.70) and providing non-respondents with a second copy of the questionnaire (1.41; 1.02 to 1.94). Questionnaires designed to be of more interest to participants were more likely to be returned (2.44; 1.99 to 3.01), but questionnaires containing questions of a sensitive nature were less likely to be returned (0.92; 0.87 to 0.98). Questionnaires originating from universities were more likely to be returned than were questionnaires from other sources, such as commercial organisations (1.31; 1.11 to 1.54). Health researchers using postal questionnaires can improve the quality of their research by using the strategies shown to be effective in this systematic review.
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              Use of existing patient-reported outcome (PRO) instruments and their modification: the ISPOR Good Research Practices for Evaluating and Documenting Content Validity for the Use of Existing Instruments and Their Modification PRO Task Force Report.

              Patient-reported outcome (PRO) instruments are used to evaluate the effect of medical products on how patients feel or function. This article presents the results of an ISPOR task force convened to address good clinical research practices for the use of existing or modified PRO instruments to support medical product labeling claims. The focus of the article is on content validity, with specific reference to existing or modified PRO instruments, because of the importance of content validity in selecting or modifying an existing PRO instrument and the lack of consensus in the research community regarding best practices for establishing and documenting this measurement property. Topics addressed in the article include: definition and general description of content validity; PRO concept identification as the important first step in establishing content validity; instrument identification and the initial review process; key issues in qualitative methodology; and potential threats to content validity, with three case examples used to illustrate types of threats and how they might be resolved. A table of steps used to identify and evaluate an existing PRO instrument is provided, and figures are used to illustrate the meaning of content validity in relationship to instrument development and evaluation. RESULTS & RECOMMENDATIONS: Four important threats to content validity are identified: unclear conceptual match between the PRO instrument and the intended claim, lack of direct patient input into PRO item content from the target population in which the claim is desired, no evidence that the most relevant and important item content is contained in the instrument, and lack of documentation to support modifications to the PRO instrument. In some cases, careful review of the threats to content validity in a specific application may be reduced through additional well documented qualitative studies that specifically address the issue of concern. Published evidence of the content validity of a PRO instrument for an intended application is often limited. Such evidence is, however, important to evaluating the adequacy of a PRO instrument for the intended application. This article provides an overview of key issues involved in assessing and documenting content validity as it relates to using existing instruments in the drug approval process.

                Author and article information

                Journal
                Health Serv Insights
                Health Serv Insights
                Health Services Insights
                Libertas Academica
                1178-6329
                2013
                04 August 2013
                : 6
                : 61-68
                Affiliations
                [1 ]Research Nurse, Chelsea and Westminster Hospital, Fulham Road, London SW10 9NH, United Kingdom.
                [2 ]Director, Family and Community Health University Research Group, School of Nursing and Midwifery, University of Western Sydney, Sydney, NSW Australia.
                [3 ]Visiting Professor, Centre for Pharmacology and Therapeutics, Imperial College, Chelsea and Westminster Campus, London, SW10 9NH, United Kingdom.
                Author notes
                Corresponding author email: sheree.smith@ 123456uws.edu.au
                Article
                hsi-6-2013-061
                10.4137/HSI.S11093
                4089835
                25114561
                55b143d0-779d-4de6-a4dc-1dbcd6d4c80f
                © 2013 the author(s), publisher and licensee Libertas Academica Ltd.

                This is an open access article published under the Creative Commons CC-BY-NC 3.0 license.

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                patient reported outcomes,patient reported measures,clinical research,patient experience

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