Case-mix methodology for the NHS outcomes framework GP patient survey questionnaire data

ObjectiveThe objective of the research described in the current report was to explore alternative methodologies which could be used to determine whether the health status of people living with long-term conditions in England is changing over time, all other factors being equal.MethodData from the Health Survey for England (HSE) were used in the analyses and EQ-5D was used to represent health related quality of life (HRQoL). The proposed case-mix ratio approach which utilised ordinary least square regressions (with the EQ-5D preference-based score as the dependent variable) was replicated, and alternatives using logistic regressions and two-part models (both using the responses to the EQ-5D health dimensions as the dependent variables) were explored. An alternative method using the HSE year as a performance indicator (PI) was explored and results presented for the four most prevalent health conditions. Results were compared in terms of errors in predicted scores and the ability to capture changes in the distributions of the preference-based scores. Both expected and simulated values were compared.ResultsThe EQ-5D data were not normally distributed irrespective of survey or health condition. The annual fluctuations in mean EQ-5D scores, and the proportions in full health, were relatively small overall but differed substantially by health condition. The annual fluctuations in mean EQ-5D scores did not necessarily describe the shifts in the EQ-5D distributions.Comparing the predicted results from the ordinary least squares (OLS) regressions and the health dimensions models, magnitude and statistical significance of the coefficients in the models differed by health condition. While the linear model was more accurate in terms of errors in the mean of predicted values for the base year (2003), it was less accurate than the logistic models for two of the remaining four surveys. The approaches were not particularly accurate at predicting EQ-5D scores across the full range of the EQ-5D index. However, the dimension models replicated the observed distributions well, unlike the linear models which produced a normally distributed sample with a proportion of scores outside the bounds of the index. The substantial errors in the predicted scores had implications with regard to the face validity of using a case-mix adjustment factor, which was based on a ratio of individual observed and predicted scores.4The results for the performance indicator models were promising and again the logistic dimension models out-performed the linear models. The magnitude and statistical significance of the coefficients in the models were both condition and health dimension specific. The linear models again predicted mean EQ-5D scores more accurately than the dimension models, but the latter performed better across the range of the EQ-5D index in terms of mean errors and mean absolute errors. This was reflected in distributions of predicted scores as the linear models predicted scores outside the EQ-5D range, covered a truncated range and did not capture the characteristics of the actual data.ConclusionWhile linear models obtained using OLS regressions performed well on the aggregate level, they did not capture the underlying distributions of the EQ-5D scores and were not able to detect shifts in these. The bias in the errors of predicted values raised questions relating to confidence in any case-mix adjustment derived from a ratio based in individual predicted scores. The results from the logistic models appeared to capture the underlying distributions far better than the linear models but additional research is required to develop this approach further.</p

Evaluating public health interventions for obesity from the perspective of local health authorities

This paper has been produced on request from the DH and is designed as a discussion document intended for dissemination to policy makers to help identify areas around which joint discussions would be useful in terms of identifying potential ideas, issues and questions relating to the project remit. Scoping searches In February and March 2011, we conducted a series of scoping searches covering both clinical databases and the internet (see Annex 2 for detailed results and methods). The object was to identify interventions or studies, devised to prevent or manage obesity, and funded by local authorities or public bodies in the Sheffield area. Given the local and specialist nature of the materials sought, the majority of relevant data are unlikely to be identified in the large health care databases such as Medline. Our findings from the scoping searches suggest that these data will be found by searching the internet to identify key schemes in a specific area and through contacting principal staff involved with the schemes. </p

Examining productivity losses associated with health related quality of life using patient and general population data

Economic evaluation is used to inform decisions related to setting priorities in health care and whether health care interventions should be reimbursed by combining information on costs with benefits. The key focus when assessing the benefits from health care interventions is health which may be assessed in natural units such as life years saved or quality adjusted life years (QALY) for use in cost effectiveness and cost utility analysis respectively. QALYs focus on the health related quality of life (HRQoL) associated with different health states which are valued by members of the general public. Costs are the direct costs of providing health care but indirect costs (not funded directly through the health care system), which result from having poor health may also be included.Indirect costs include productivity losses which refer to costs associated with time off paid and unpaid work due to illness. Measuring the productivity losses associated with specific health conditions has typically focused on self-reported or objective data on time off work (Zhang et al.2011). A different approach relies on estimating productivity directly from the health states. This allows productivity losses associated with different health states to be predicted where this information is not available. In order to assess the relationship between productivity and health, patient datasets containing information on health related quality of life (HRQoL) on a wide range of conditions measured using accepted HRQoLmeasures (such as EQ-5D) alongside productivity information are required. This would allow productivity losses, for example days off work, to be linked to particular health states described by these HRQoL measures. In addition to patient data, the recall period for the HRQoL measures should match the recall period of the productivity losses to minimise bias associated with mismatch due to different recall periods. For example, the recall period in the EQ-5D is today whereas measures of productivity such as the Health and Labour Questionnaire (van Roijen et al.1996) use a two-week recall period. Larger studies focusing on productivity tend to ask respondents to consider longer periods such as four weeks, three (six or twelve) months (Zhang et al.2011). Linking longer productivity losses to current HRQoL may either overestimate or underestimate the effect of conditions. This aggregate approach of estimating productivity has been used by Krol et al.(2013) using Dutch general public data, and Rowen et al.(2013) using UK patient data. Krol et al.(2013) used the EQ-5D and hypothetical time off work estimated by the respondents to develop their model. Rowen et al.(2013) used EQ-5D, International Classification of Diseases (ICD 10) codes and self-reported days of work to develop models to predict productivity losses. Models from Rowen et al.(2013) are 6 applicable in the UK setting as they use the recommended heatlh technology assessment measure, the EQ-5D, and have clinical diagnosis data based on ICD which is used by the Department of Health in the UK. However, Rowen et al.(2013) identified a number of limitations which may limit applicability of their research.The patient dataset that was used represents individuals who had recently been hospitalised and on average, these patients are likely to be sicker than the typical patient treated by the National Health Service (NHS) in the UK. Sicker respondents are likely to have higher productivity losses and models derived from these data would overestimate the productivity effects in typical patients. There were also concerns that different recall periods were used for the HRQoL measure (EQ-5D) and the number of days off work. The EQ-5D recall period was today while productivity information related to the previous 6 weeks. Some individuals who reported full health (EQ-5D=1) also reported having a large number of days off work and this may have been a result of the mismatch in recall periods.The work described in this report was commissioned by the Department of Health to inform its work on Value-Based-Pricing (VBP) (Department of Health, 2010), which is due to replace the current Pharmaceutical Pricing Regulation Scheme (PPS) in January 2014 for pricing medicines in the UK.VBP will include additional payments to interventions that are deemed to provide benefit that is of greater social value instead of the current narrow focus on outcomes relevant to the NHS and Personal Social Services (PSS). This requires taking into account wider societal benefits of medicines beyond the health of the patient including productivity.</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 D, Epilepsy.

The Policy Research Unit in Economic Evaluation of Health and Care Interventions (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-5D (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 epilepsy 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 C, Inflammatory Bowel Disease.

The Policy Research Unit in Economic Evaluation of Health and Care Interventions (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-5D (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.EEPRU NCA Appendix C: Inflammatory Bowel Disease This Appendix provides the detailed results for the condition inflammatory bowel disease (IBD) 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 E, Diabetes.

The Policy Research Unit in Economic Evaluation of Health and Care Interventions (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-5D (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.This Appendix provides the results for diabetes and should be read in conjunction with both the main report and the method/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 F, Bowel 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 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 bowel cancer and should be read in conjunction with both the main report and the methods/search strategy appendices.</p

A rapid review of the cost-effectiveness of alternative interventions across cancer care pathways: radiotherapy and surgery

Introduction: Based on a scope determined by the Department of Health, a rapid review was undertaken to explore the existing literature describing the cost-effectiveness of surgical and/or radiotherapy interventions in patients with (i) breast cancer, (ii) colorectal cancer, (iii) prostate cancer, (iv) cervical cancer and (v) head and neck cancer. The aim was to assess the relevance of the cost-effectiveness evidence to current UK policy and decision making.Methods: Full systematic literature searches were undertaken with tiered criteria used for inclusion of studies into the eight reviews. Inclusion criteria were based on the relevance of studies to policy decision making. Cost-effectiveness studies analysing the incremental cost per quality adjusted life year (QALY) or cost per life year (LY) met the initial, preferred criteria. Cost per QALY analyses enable comparison across other disease areas and reflect the methods guidance for the NICE reference case. The studies in each cancer area were sub-grouped into clinically meaningful categories where possible and were assessed in terms of their alignment with the NICE reference case. Relevance of the interventions in terms of current UK clinical practice was informed by clinical experts.Findings: Almost 9,000 studies were identified and screened for inclusion. Of these, 45 studies met the initial criteria for inclusion in the reviews. Applying the NICE threshold value of £30k per QALY at the time of publication, irrespective of setting or adherence to the NICE methods guide:Breast cancer, surgery, based on three non-UK based studies:• breast conserving surgery plus axillary mode dissection compared to modified radical mastectomy would be considered cost-effective (£12.8k per QALY)• breast conservation surgery with radiation therapy compared to mastectomy would not be considered cost-effective. There are multiple reasons for this including cosmesis, patient preferences and the added cost of reconstruction which is employed after mastectomy in over 20% of all cases. (This comparison is no longer appropriate in the current clinical context as it is now current practice, with rare exceptions, for radiation to be administered after conservation therapy)Breast cancer, radiotherapy, based on one UK study and 13 non-UK studies:• whole breast radiotherapy following breast conservation is generally considered cost-effective (range £3.0k to £23k per QALY), but further studies are required to identify a very 3low risk group of patients who derive minimal benefit and can therefore safely avoid radiotherapy (cost per QALY much greater than threshold in low risk patients)• post-mastectomy radiotherapy is cost-effective in patients at higher risk of recurrence but the definition of this level of risk is not clear (£19k per QALY to dominating (lower costs and larger benefits))• partial breast radiotherapy is still experimental and there is currently insufficient mature outcome data from which to draw conclusions about the cost-effectiveness of this interventionColorectal cancer, surgery, based on two UK studies and three non UK studies:• comparing laparoscopic surgery to open surgery, although there is a large amount of uncertainty in the results reported (ranging from dominating (lower costs and larger benefits) to dominated (higher costs and lower benefits) based on the two UK studies), laparoscopic surgery is currently recommended in the UK due to the potential short-term quality of life benefits• emergency colonic stenting dominated emergency surgery in patients with emergent, malignant left colonic obstruction• surgical resection with both diagnostic/palliative surgery is dominated by non-surgical treatmentColorectal cancer, radiotherapy, based on two non UK based studies:• preoperative radiotherapy followed by surgery compared to surgery alone would be considered cost-effective (range £2.3k to £15.7k per QALY)Prostate cancer, surgery, based on two UK studies and four non-UK based studies:• radical prostatectomy in patients with localised prostate cancer was dominated by watchful waiting based on a UK study• radical prostatectomy would be considered cost-effective in patients with localised prostate cancer compared to watchful watching only when side-effects of the surgical technique are excluded (£8k per QALY)Prostate cancer, radiotherapy, based on one UK study and nine non-UK studies:• cryotherapy compared to traditional radiotherapy and radical prostatectomy would not be considered cost-effective based on the UK study (over £100k per QALY) 4• brachytherapy and 3D conformal radiation would be considered cost-effective compared to traditional radiotherapy and radical prostatectomy (£0.7k to £11.7k per QALY)• intensity modulated radiotherapy compared to 3D conformal radiation would be considered cost-effective (£10.5 to £25k per QALY)• radiotherapy plus hormone therapy compared to just radiotherapy in locally advanced patients would be considered cost-effective (lower costs and larger benefits)• single or multi-fraction radiotherapy compared to palliative treatments (pain medication or chemotherapy) in hormone-refractory prostate cancer patients would be considered cost-effective (£4.2k to £22.4)Cervical cancer, radiotherapy: Although 13 full papers were retrieved for review, none satisfied the initial or relaxed inclusion criteria.Head and neck cancer, radiotherapy, based on three non-UK studies:• trans oral CO2 laser excision dominated external beam radiation for patients with T1 glottic carcinoma (lower costs and higher QALY)• accelerated fractionated radiotherapy with concomitant boost, and hyper fractionated radiotherapy would be considered cost-effective compared to standard fractionated radiotherapy in patients with local advanced head and neck cancer (£8.8k to £15k per QALY) proton therapy would be considered cost-effective compared to conventional radiotherapy (£3.1k per QALY)Caveats: The results presented here should be treated with caution as there are some fundamental issues which limit the generalisability of the results to current policy decision making in the UK. In particular, the relevance to current UK clinical practice is questionable for some indications, very few of the studies were based in the UK and international costs of interventions and health care do not generally transfer to the UK; the clinical evidence used in the majority of the studies is dated and rarely synthesised to capture all the uncertainty associated with the particular interventions under evaluation.</p