SUPPORTING THE ROUTINE COLLECTION OF PATIENT REPORTED OUTCOME MEASURES IN THE NATIONAL CLINICAL AUDITS FOR ASSESSING COST EFFECTIVENESS Work Package 1 - What patient reported outcome measures should be used in the 13 health conditions specified in the 2013/14 National Clinical Audit programme?
OBJECTIVES: To assess the appropriateness of the EQ-5D in 13 specified conditions (inflammatory bowel disease (IBD), epilepsy, diabetes, bowel cancer, head and neck cancer, psychological therapies, schizophrenia, dementia, cardiac arrhythmia, heart failure, coronary angioplasty, acute coronary syndrome, adult cardiac surgery); identify what measures may be used when the EQ-5D is not appropriate; identify if fields in corresponding National Clinical Audits (NCA) will suffice to conduct economic evaluations; present recommendations and future research questions in this area.
METHOD: For each condition, three reviews were considered (WP1.1, 1.2 and 1.3). WP1.1 comprised a review of the appropriateness of the EQ-5D. Known reviews were assessed in the first instance for adequacy according to a set of criteria and expert opinion. Where a known review was not available or not adequate, a systematic review of systematic reviews was conducted. Where no adequate systematic review was identified, a systematic review of primary studies was conducted. For WP1.1, systematic searches were conducted in PubMed and Embase and two conference proceedings citation indexes (Web of Science and EuroQoL) using appropriate free-text keywords and MeSH/thesaurus terms, and applying appropriate limits according to the review being conducted (review of reviews or of primary studies). WP1.2 comprised a review of condition specific measures that could be used and was only conducted for conditions where there was evidence that the EQ-5D was not adequate. This review consulted several online sources, such as Royal College websites, to identify research guidelines describing which condition specific measures should be used in research. WP1.3 comprised a review of existing cost-effectiveness evaluations used in recent health technology assessments (HTA) across the 13 conditions. Multiple technology appraisals (MTA) and single technology appraisals (STA) were systematically identified from the National Institute for Health and Care Excellence (NICE) HTA programme and the methods used to assess the cost effectiveness were extracted and compared to the data collected routinely in the NCAs.
In all reviews, retrieved citations were considered for inclusion against a set of standardised selection criteria by one reviewer, and a second reviewer consulted in cases of uncertainty. Syntheses included tabulation of study results and either: presentation of a structured abstract and critique in the case of included systematic reviews or HTAs (WP1.1, 1.3); a narrative synthesis and discussion of results in the case of primary studies (WP1.1); or a tabulation and narrative synthesis in the case of research guidelines (WP1.2).
RESULTS:
Patient reported outcome measures (WP1.1 and 1.2)
For WP1.1, conclusions were drawn from known reviews in four cases (psychological therapies; diabetes; epilepsy children; dementia); from updates and reanalyses of existing reviews in five cases (epilepsy adults; bowel cancer; head and neck cancer; schizophrenia; CVD); and from systematic reviews of primary studies in two cases (IBD adults; IBD children). For WP1.2, six reviews of the literature, augmented with literature known to the authors, were used to identify alternative or additional patient reported outcome measures (PROMs) for patients with epilepsy (paediatrics), IBD (paediatrics), schizophrenia, head and neck cancer, dementia, and patients receiving psychological therapies.
The psychometric properties of the EQ-5D were found to be adequate in ten of the 13 conditions. The exceptions were epilepsy (where the Paediatric quality of life inventory (PedsQL)TM was recommended), schizophrenia (where WEMWBS, to be replaced by ReQOL, was recommended) and dementia (where DEMQOL-U was recommended).
With the exception of the mental health condition, no reference was made to the possibility of the EQ-5D being less responsive in older age groups. The presence of comorbidities in subjects was not reported in either the existing reviews or most of the primary studies. However, as the presence of comorbidities was not identified as an explicit exclusion criterion in all but the metal health review and in the diabetes studies, and the broad age ranges covered, it is assumed that the results and conclusions drawn will generalise across subjects with comorbidities.
Funding
NIHR Policy Research Unit - Economic Methods of Evaluation in Health and Care Interventions
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