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? Appendix I, Schizophrenia

EEPRU was approached by Jason Cox (R&D Division) to prepare a programme of research to support the appropriateness of, and use of, patient reported outcome measures (PROMs) collected for the National Clinical Audit (NCA). The EEPRU programme was informed by a R&D template prepared by Simon Bennett, Steve Fairman and Keith Willett at NHS England.The purpose of introducing PROMs into the NCA programme is to be able to 1) compare performance between providers and commissioners in the National Health Service (NHS), 2) compare the cost-effectiveness of alternative providers in delivering the specific services (i.e. linking outcomes and resource use), and 3) assess the cost-effectiveness of alternative interventions and other changes in the NHS. The intention is to introduce PROMs across a range of conditions over the next 3 years commencing with 13 conditions in the 2014/15 NCA programme.The agreed research programme consists of 3 concurrent work packages (WP) as described in the document submitted to the Department of Health (DH) (8th November 2013). The current document provides details on the objectives, methodology and results for Work Package 1 (WP1): to determine what PROMS should be used in the 13 health conditions specified in the 2014/15 NCA programme.2. OVERVIEWWP1 is split into three separate components consisting of:WP1.1 To examine whether the EuroQoL 5 dimensions (EQ-5D) is appropriate in the 13 health conditions specified in the 2013/14 NCA programme.WP1.2 To identify what measure could be used when the EQ-5D is not appropriate in the 13 health conditions, taking into account that the proposed measure would be used to generate preference-based utility measures (either directly through existing preference-based weights, or indirectly through existing mapping functions suitable for the proposed measure).WP1.3 To identify the evidence required to address questions of cost-effectiveness using the NCA data.Each component consists of a series of reviews of the literature and the specific review objectives and methodologies are described in detail in the following sections.</p

Supporting the routine collection of patient reported outcome measures (PROMS) for the national clinical audit work package 2 how should proms data be collected?

ObjectivesAcross health care settings, electronic patient reported outcome measures (e-PROMs) can be administered using a range of systems and administration modes (for example web-based, mobile phones or kiosks). The use of e-PROMs is not widespread in the UK and there is no clear guidance regarding the best ways in which to deliver the questionnaires, set up and implement the systems required, or feedback data to clinicians, other health care professionals and patients.The overall aim of the research described in this report is to understand current practice for the administration and application of e-PROMs in health care settings, to inform the use of these measures in the National Clinical Audit (NCA), and to identify areas where future research would be beneficial. The specific objectives are threefold:1. Identify and critique the existing evidence on the use of electronic methods for the administration of PROMs for routine use in health care settings and the systems used to deliver them.2. Review the potential benefits, uses and applications of e-PROMs.3. Highlight the challenges involved in the collection and implementation of e-PROMs.MethodsExisting literature and interviews with clinicians and academics working in the field were used to understand the current practice for the administration and application of e-PROMs. To source existing literature, four different approaches were used. The first approach involved searching International Society for Pharmacoeconomics and Outcomes Research and the International Society for Quality of Life Research websites which list publications relating to e-PROMs. The second approach involved searching several conference abstract websites. The third approach involved searches for UK and international guidelines, recommendations and standards. The fourth approach adopted was to ask the interviewees whether they knew of relevant papers and reports (published or unpublished).The qualitative study was carried out with a selection of clinicians and researchers with experience of developing, applying and using e-PROMs. Potential interviewees were identified from contacts known by the research team. A snowball approach was used to develop a long list of potential interviewees who were asked to take part. A semi-structured interview guide based on the objectives of the project, the results of key review papers in the area, and the personal experience of the research team were used. Interviews were transcribed verbatim, and analysed using a simple content analysis approach where the interview topic guide was used to code the interviews.Results and conclusionsA wide range of published articles, reviews and abstracts were sourced. Nine interviews were carried out with academics (n=3) and clinicians (n=6). The data sources provided information regarding: the mode of administration and specifics of collecting e-PROMS, the benefits and impacts of using e-PROMs, engagement of others regarding the use of e-PROMs, and the challenges of implementing and using e-PROMs. The results provide important evidence that can be used to inform the implementation of e-PROMs as part of the NCA, and about potential difficulties in the widespread application of these systems. From this, recommendations for the implementation of e-PROMs can be drawn. These include: Using multiple data collection modes to improve response rates. There is some evidence to suggest that there are limited issues of equivalence of using different modes of administration. Allowing multiple places of completion (i.e. home and in clinical settings). Gaining support from all key stakeholders (i.e. clinicians, IT departments, support staff, patients). Using the PROMs data in clinical decision making. Developing systems in a collaborative manner. Choosing which PROMs to use based on the available evidence and the purpose of the system.There are a range of limitations of existing e-PROMs systems. The systems do not always have the full support of clinicians and other key stakeholders (such as other staff or managers and commissioners) involved in their implementation. Mixed response rates are also reported. It is unclear how best to maximise response beyond offering as much flexibility as possible.Future researchThe results of this study highlight a number of areas where future research would be informative for the NCA. These include: Investigating how to maximise response rates. Investigating how to engage clinicians and users. Investigating how to present the PROMs data to patients, clinicians, providers and commissioners. Evaluating the benefits of collecting PROMs. Carrying out usability research into the presentation of the e-PROM systems across different modes of administration. Investigating how different clinical pathways would most benefit from e-PROMs. Investigating equity issues and the impact of e-PROMs on the application of the systems.</p

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? Appendix J, Dementia

EEPRU was approached by Jason Cox (Research and development (R&D) Division) to prepare a programme of research to support the appropriateness of, and use of, patient reported outcome measures (PROMs) collected for the National Clinical Audit (NCA). The EEPRU programme was informed by a R&D template prepared by Simon Bennett, Steve Fairman and Keith Willett at National Health Service (NHS) England.The purpose of introducing PROMs into the NCA programme is to be able to 1) compare performance between providers and commissioners in the NHS, 2) compare the cost-effectiveness of alternative providers in delivering the specific services (i.e. linking outcomes and resource use), and 3) assess the cost-effectiveness of alternative interventions and other changes in the NHS. The intention is to introduce PROMs across a range of conditions over the next 3 years commencing with 13 conditions in the 2014/15 NCA programme.The agreed research programme consists of 3 concurrent work packages (WP) as described in the document submitted to the Department of Health (DH) (8th November 2013). The current document provides details on the objectives, methodology and results for Work Package 1 (WP1): to determine what PROMS should be used in the 13 health conditions specified in the 2014/15 NCA programme.2. OVERVIEWWP1 is split into three separate components consisting of:WP1.1 To examine whether the EuroQol 5 dimensions (EQ-5D) is appropriate in the 13 health conditions specified in the 2013/14 NCA programme.WP1.2 To identify what measure could be used when the EQ-5D is not appropriate in the 13 health conditions, taking into account that the proposed measure would be used to generate preference-based utility measures (either directly through existing preference-based weights, or indirectly through existing mapping functions suitable for the proposed measure).WP1.3 To identify the evidence required to address questions of cost-effectiveness using the NCA data.Each component consists of a series of reviews of the literature.This Appendix provides the detailed results for the condition dementia and should be read in conjunction with both the main report and the methods/search strategy appendices.</p

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.</p

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? Appendix G, Head and Neck Cancer

EEPRU was approached by Jason Cox (R&D Division) to prepare a programme of research to support the appropriateness of, and use of, patient reported outcome measures (PROMs) collected for the National Clinical Audit (NCA). The EEPRU programme was informed by a Research and Development (R&D) template prepared by Simon Bennett, Steve Fairman and Keith Willett at NHS England.The purpose of introducing PROMs into the NCA programme is to be able to 1) compare performance between providers and commissioners in the National Health Service (NHS), 2) compare the cost-effectiveness of alternative providers in delivering the specific services (i.e. linking outcomes and resource use), and 3) assess the cost-effectiveness of alternative interventions and other changes in the NHS. The intention is to introduce PROMs across a range of conditions over the next 3 years commencing with 13 conditions in the 2014/15 NCA programme.The agreed research programme consists of 3 concurrent work packages (WP) as described in the document submitted to the DH (8th November 2013). The current document provides details on the objectives, methodology and results for Work Package 1 (WP1): to determine what PROMS should be used in the 13 health conditions specified in the 2014/15 NCA programme.2. OVERVIEWWP1 is split into three separate components consisting of:WP1.1 To examine whether the Euro-QoL 5 dimensions (EQ-5D) is appropriate in the 13 health conditions specified in the 2013/14 NCA programme.WP1.2 To identify what measure could be used when the EQ-5D is not appropriate in the 13 health conditions, taking into account that the proposed measure would be used to generate preference-based utility measures (either directly through existing preference-based weights, or indirectly through existing mapping functions suitable for the proposed measure).WP1.3 To identify the evidence required to address questions of cost-effectiveness using the NCA data.Each component consists of a series of reviews of the literature.This Appendix provides the detailed results for the condition head and neck cancer and should be read in conjunction with both the main report and the methods/search strategy appendices.</p

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? Appendix H, Psychological Therapies

EEPRU was approached by Jason Cox (R&D Division) to prepare a programme of research to support the appropriateness of, and use of, patient reported outcome measures (PROMs) collected for the National Clinical Audit (NCA). The EEPRU programme was informed by a Research and Development (R&D) template prepared by Simon Bennett, Steve Fairman and Keith Willett at NHS England.The purpose of introducing PROMs into the NCA programme is to be able to 1) compare performance between providers and commissioners in the National Health Service (NHS), 2) compare the cost-effectiveness of alternative providers in delivering the specific services (i.e. linking outcomes and resource use), and 3) assess the cost-effectiveness of alternative interventions and other changes in the NHS. The intention is to introduce PROMs across a range of conditions over the next 3 years commencing with 13 conditions in the 2014/15 NCA programme.The agreed research programme consists of 3 concurrent work packages (WP) as described in the document submitted to the DH (8th November 2013). The current document provides details on the objectives, methodology and results for Work Package 1 (WP1): to determine what PROMS should be used in the 13 health conditions specified in the 2014/15 NCA programme.2. OVERVIEWWP1 is split into three separate components consisting of:WP1.1 To examine whether the Euro-QoL 5 dimensions (EQ-5D) is appropriate in the 13 health conditions specified in the 2013/14 NCA programme.WP1.2 To identify what measure could be used when the EQ-5D is not appropriate in the 13 health conditions, taking into account that the proposed measure would be used to generate preference-based utility measures (either directly through existing preference-based weights, or indirectly through existing mapping functions suitable for the proposed measure).WP1.3 To identify the evidence required to address questions of cost-effectiveness using the NCA data.Each component consists of a series of reviews of the literature.This Appendix provides the detailed results for recipients of psychological therapies and should be read in conjunction with both the main report and the methods/search strategy appendices.</p

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? Appendix K, Cardiovascular Disease

1. BACKGROUNDEEPRU was approached by Jason Cox (R&D Division) to prepare a programme of research to support the appropriateness of, and use of, patient reported outcome measures (PROMs) collected for the National Clinical Audit (NCA). The EEPRU programme was informed by a R&D template prepared by Simon Bennett, Steve Fairman and Keith Willett at NHS England.The purpose of introducing PROMs into the NCA programme is to be able to 1) compare performance between providers and commissioners in the National Health Service (NHS), 2) compare the cost-effectiveness of alternative providers in delivering the specific services (i.e. linking outcomes and resource use), and 3) assess the cost-effectiveness of alternative interventions and other changes in the NHS. The intention is to introduce PROMs across a range of conditions over the next 3 years commencing with 13 conditions in the 2014/15 NCA programme.The agreed research programme consists of 3 concurrent work packages (WP) as described in the document submitted to the DH (8th November 2013). The current document provides details on the objectives, methodology and results for Work Package 1 (WP1): to determine what PROMS should be used in the 13 health conditions specified in the 2014/15 NCA programme.2. OVERVIEWWP1 is split into three separate components consisting of:WP1.1 To examine whether the EQ-5D is appropriate in the 13 health conditions specified in the 2013/14 NCA programme.WP1.2 To identify what measure could be used when the EQ-5D is not appropriate in the 13 health conditions, taking into account that the proposed measure would be used to generate preference-based utility measures (either directly through existing preference-based weights, or indirectly through existing mapping functions suitable for the proposed measure).WP1.3 To identify the evidence required to address questions of cost-effectiveness using the NCA data.Each component consists of a series of reviews of the literature.This Appendix provides the detailed results for the cardiovascular disease (CVD), which include cardiac arrhythmia, heart failure (HF), coronary angioplasty, cardiac surgery and acute coronaryEEPRU NCA Appendix K: Cardiovascular Disease syndrome (ACS), and should be read in conjunction with both the main report and the methods/search strategy appendices.3. METHODThe full detailed methodology used is provided in Appendix A, including the search strategy, selection criteria for studies included, and data extraction etc. In summary, for each included cardiovascular condition a review of the literature was undertaken to assess the appropriateness of the EQ-5D in terms of classic psychometric criteria (WP1.1); where the EQ-5D was not considered appropriate, additional searches were undertaken to identify alternative measures (WP1.2); and finally, existing health technology appraisals were reviewed and data requirements were compared with variables currently collected in the CVD audits (WP1.3).</p