Is well-becoming important for children and young people? Evidence from in-depth interviews with children and young people and their parents.

PURPOSE: This study explores how important well-becoming factors appear to be to children during childhood. We define well-becoming as the indicators which predict children and young people's future wellbeing and opportunities. The priority for this work was to explore whether well-becoming might be an important factor to include in outcome measures for children and young people. The inclusion of well-becoming indicators could ensure that opportunities to invest in promoting wellbeing in children's futures are not missed. METHODS: In-depth, qualitative interviews (N = 70) were undertaken with children and young people aged 6-15 years and their parents. Analysis used constant comparison and framework methods to investigate whether well-becoming factors were considered important by informants to children and young people's current wellbeing. RESULTS: The findings of the interviews suggested that children and young people and their parents are concerned with future well-becoming now, as factors such as future achievement, financial security, health, independence, identity, and relationships were identified as key to future quality of life. Informants suggested that they considered it important during childhood to aspire towards positive outcomes in children and young people's futures. CONCLUSION: The study findings, taken alongside relevant literature, have generated evidence to support the notion that future well-becoming is important to current wellbeing. We have drawn on our own work in capability wellbeing measure development to demonstrate how we have incorporated a well-becoming attribute into our measures. The inclusion of well-becoming indicators in measures could aid investment in interventions which more directly improve well-becoming outcomes for children and young people.

Expanding health technology assessment towards broader value: Ireland as a case study.

Healthcare innovations often represent important improvements in population welfare, but at what cost, and to whom? Health technology assessment (HTA) is a multidisciplinary process to inform resource allocation. HTA is conventionally anchored on health maximization as the only relevant output of health services. If we accept the proposition that health technologies can generate value outside the healthcare system, resource allocation decisions could be suboptimal from a societal perspective. Incorporating "broader value" in HTA as derived from social values and patient experience could provide a richer evaluative space for informing resource allocation decisions. This article considers how HTA is practiced and what its current context implies for adopting "broader value" to evaluating health technologies. Methodological challenges are highlighted, as is a future research agenda. Ireland serves as an example of a healthcare system that both has an explicit role for HTA and is evolving under a current program of reform to offer universal, single-tier access to public services. There are various ways in which HTA processes could move beyond health, including considering the processes of care delivery and/or expanding the evaluative space to some broader concept of well-being. Methods to facilitate the latter exist, but their adaptation to HTA is still emerging. We recommend a multi-stakeholder working group to develop and advance an international agenda for HTA that captures welfare/benefit beyond health.

A think-aloud study of the feasibility of patients with end-stage organ failure completing the ICECAP-SCM.

BACKGROUND: The ICECAP-Supportive Care Measure (SCM) is a self-complete measure developed to inform economic decision making at the end-of-life. Previous research has demonstrated its feasibility in hospice and nursing home settings. This is the first study of its use with patients on the organ failure trajectory. AIM: To determine the feasibility of using the ICECAP-SCM with patients experiencing end-stage organ failure in a hospital setting. DESIGN: Participants were asked to 'think aloud' when completing the ICECAP-SCM, ICECAP-A and EQ-5D-5L measures. The interviews were transcribed verbatim and examined for errors in comprehension, retrieval, judgement, and response by five raters. Qualitative data were collected to explore reasons for errors in completing the measures and participants' views about the measures. SETTING/PARTICIPANTS: Sixty patients (with end-stage renal failure n = 18; end-stage heart failure n = 21; end-stage chronic obstructive pulmonary disease n = 21) participated. Senior clinicians applied prognostic criteria to determine eligibility. RESULTS: Participants reported that the measures were acceptable, clear, and easy to complete. Error rates in completing the measures were low (ICECAP-A = 3%,and ICECAP-SCM = 5.7% and EQ-5D-5L = 6.3%). There was some variation in responses between patients with different end-stage conditions, particularly those with symptom fluctuation. Some patients had not considered their end-of-life (i.e. advance care planning) and reported finding questions about this difficult to answer. CONCLUSION: It is feasible to use the ICECAP-SCM with patients with end-stage organ failure receiving care in hospital settings. This study provides evidence for researchers and policy makers involved in measuring end-of-life care globally. The ICECAP-SCM can be recommended for research with patients in end-stage organ failure to appropriately capture the broader benefits of end-of-life care.

An analysis of the construct validity and responsiveness of the ICECAP-SCM capability wellbeing measure in a palliative care hospice setting.

BACKGROUND: For outcome measures to be useful in health and care decision-making, they need to have certain psychometric properties. The ICECAP-Supportive Care Measure (ICECAP-SCM), a seven attribute measure (1. Choice, 2. Love and affection, 3. Physical suffering, 4. Emotional suffering, 5. Dignity, 6. Being supported, 7. Preparation) developed for use in economic evaluation of end-of-life interventions, has face validity and is feasible to use. This study aimed to assess the construct validity and responsiveness of the ICECAP-SCM in hospice inpatient and outpatient settings. METHODS: A secondary analysis of data collated from two studies, one focusing on palliative care day services and the other on constipation management, undertaken in the same national hospice organisation across three UK hospices, was conducted. Other quality of life and wellbeing outcome measures used were the EQ-5D-5L, McGill Quality of Life Questionnaire - Expanded (MQOL-E), Patient Health Questionnaire-2 (PHQ-2) and Palliative Outcomes Scale Symptom list (POS-S). The construct validity of the ICECAP-SCM was assessed, following hypotheses generation, by calculating correlations between: (i) its domains and the domains of other outcome measures, (ii) its summary score and the other measures' domains, (iii) its summary score and the summary scores of the other measures. The responsiveness of the ICECAP-SCM was assessed using anchor-based methods to understand change over time. Statistical analysis consisted of Spearman and Pearson correlations for construct validity and paired t-tests for the responsiveness analysis. RESULTS: Sixty-eight participants were included in the baseline analysis. Five strong correlations were found with ICECAP-SCM attributes and items on the other measures: four with the Emotional suffering attribute (Anxiety/depression on EQ-5D-5L, Psychological and Burden on MQOL-E and Feeling down, depressed or hopeless on PHQ-2), and one with Physical suffering (Weakness or lack of energy on POS-S). ICECAP-SCM attributes and scores were most strongly associated with the MQOL-E measure (0.73 correlation coefficient between summary scores). The responsiveness analysis (n = 36) showed the ICECAP-SCM score was responsive to change when anchored to changes on the MQOL-E over time (p < 0.05). CONCLUSIONS: This study provides initial evidence of construct validity and responsiveness of the ICECAP-SCM in hospice settings and suggests its potential for use in end-of-life care research.

Test-guided dietary management of eczema in children: A randomized controlled feasibility trial (TEST).

BACKGROUND: Parents commonly ask about food allergy tests, to find a cause for their child's eczema, yet the value of routine testing is uncertain. OBJECTIVE: To determine whether a clinical trial comparing test-guided dietary advice versus usual care, for the management of eczema, is feasible. METHODS: Children (>3 months and <5 years) with mild-to-severe eczema, recruited via primary care, were individually randomized (1:1) to intervention or usual care. Intervention participants underwent structured allergy history and skin prick tests (SPT) with dietary advice for cow's milk, hen's egg, wheat, peanut, cashew and codfish. All participants were followed up for 24 weeks. A sample of doctors and parents was interviewed. Registration ISRCTN15397185. RESULTS: From 1059 invitation letters sent to carers of potentially eligible children, 84 were randomized (42 per group) with mean age of 32.4 months (SD 13.9) and POEM of 8.7 (4.8). Of the 42, 6 (14%) intervention participants were advised to exclude one or more foods, most commonly egg, peanut or milk. By participant, 1/6 had an oral food challenge (negative); 3/6 were told to exclude until review in allergy clinic; and 6/6 advised a home dietary trial (exclusion and reintroduction of food over 4-6 weeks) - with 1/6 partially completing it. Participant retention (four withdrawals) and data completeness (74%-100%) were acceptable and contamination low (two usual care participants had allergy tests). There were three minor SPT-related adverse events. During follow-up, 12 intervention and 8 usual care participants had minor, unrelated adverse events plus one unrelated hospital admission. CONCLUSIONS: It is possible to recruit, randomize and retain children with eczema from primary care into a trial of food allergy screening and to collect the outcomes of interest. Changes to recruitment and inclusion criteria are needed in a definitive trial, to ensure inclusion of younger children from more diverse backgrounds.

Cost-effectiveness of screening and treatment using direct-acting antivirals for chronic Hepatitis C virus in a primary care setting in Karachi, Pakistan.

Despite the availability of effective direct-acting antiviral (DAA) treatments for Hepatitis C virus (HCV) infection, many people remain undiagnosed and untreated. We assessed the cost-effectiveness of a Médecins Sans Frontières (MSF) HCV screening and treatment programme within a primary health clinic in Karachi, Pakistan. A health state transition Markov model was developed to estimate the cost-effectiveness of the MSF programme. Programme cost and outcome data were analysed retrospectively. The incremental cost-effectiveness ratio (ICER) was calculated in terms of incremental cost (2016 US$) per disability-adjusted life year (DALY) averted from the provider's perspective over a lifetime horizon. The robustness of the model was evaluated using deterministic and probabilistic sensitivity analyses (PSA). The ICER for implementing testing and treatment compared to no programme was US$450/DALY averted, with 100% of PSA runs falling below the per capita Gross Domestic Product threshold for cost-effective interventions for Pakistan (US$1,422). The ICER increased to US$532/DALY averted assuming national HCV seroprevalence (5.5% versus 33% observed in the intervention). If the cost of liver disease care was included (adapted from resource use data from Cambodia which has similar GDP to Pakistan), the ICER dropped to US$148/DALY, while it became cost-saving if a recently negotiated reduced drug cost of $75/treatment course was assumed (versus $282 in base-case) in addition to cost of liver disease care. In conclusion, screening and DAA treatment for HCV infection are expected to be highly cost-effective in Pakistan, supporting the expansion of similar screening and treatment programmes across Pakistan.

Measurement Instruments of Productivity Loss of Paid and Unpaid Work: A Systematic Review and Assessment of Suitability for Health Economic Evaluations From a Societal Perspective.

OBJECTIVES: This study aimed (1) to perform a systematic literature review of instruments for measuring productivity loss of paid and unpaid work and (2) to assess the suitability (in terms of identification, measurement, and valuation) of these instruments for use in health economic evaluations from a societal perspective. METHODS: Articles published from 2018 were sourced from PubMed/Medline, PsycInfo, Embase, and Econlit. Using 2 separate search strategies, eligible economic evaluations and validation studies were selected and unique measurement instruments identified. A data-extraction form was developed by studying previous literature and consulting an international panel of experts in the field of productivity costs. This data-extraction form was applied to assess the suitability of instruments for use in economic evaluations. RESULTS: A total of 5982 articles were retrieved from the databases, of which 99 economic evaluations and 9 validation studies were included in the review. A total of 42 unique measurement instruments were identified. Nine instruments provided quantified measures of absenteeism, presenteeism, and unpaid work. Five instruments supplied the necessary information to enable the use of at least 1 common valuation method. The Health and Labour Questionnaire-Short Form, Health and Labour Questionnaire, and Institute for Medical Technology Assessment Productivity Cost Questionnaire met both criteria. Nevertheless, the developers replaced the Health and Labour Questionnaire-Short Form and Health and Labour Questionnaire by the more recently developed Institute for Medical Technology Assessment Productivity Cost Questionnaire. CONCLUSIONS: Although many instruments for measuring productivity loss were identified, most were not suitable for capturing productivity changes for economic evaluations from a societal perspective. Future research can benefit from this study by making an informed instrument choice for the measurement of productivity loss of paid and unpaid work.

"It is not a scientific number it is just a feeling": Populating a multi-dimensional end-of-life decision framework using deliberative methods.

The capability approach is potentially valuable for economic evaluation at the end of life because of its conceptualization of wellbeing as freedom and the potential for capturing outcomes for those at end of life and those close to persons at the end of life. For decision making, however, this information needs to be integrated into current evaluation paradigms. This research explored weights for an integrated economic evaluation framework using a deliberative approach. Twelve focus groups were held (38 members of the public, 29 "policy makers," seven hospice volunteers); budget pie tasks were completed to generate weights. Constant comparison was used to analyze qualitative data, exploring principles behind individuals' weightings. Average weights elicited from members of the general population and policy makers for the importance that should be given to close persons (vs. patients) were very similar, at around 30%. A "sliding scale" of weights between health gain and the capability for a good death resulted from the policy maker and volunteer groups, with increasing weight given to the capability for a good death as the trajectory got closer to death. These weights can be used in developing a more comprehensive framework for economic evaluation at end of life.

Challenges in developing capability measures for children and young people for use in the economic evaluation of health and care interventions.

Methods for measuring outcomes suitable for economic evaluations of health and care interventions have primarily focused on adults. The validity of such methods for children and young people is questionable in areas including the outcome domains measured and how they are measured and valued, with most existing measures narrowly focusing on health. Novel methods for assessing benefits beyond health by focusing on a person's capability have also concentrated on adults to date. This paper aims to set out the rationale for capability measures in children and young people. It argues for the need to expand the evaluative space beyond health functioning towards broader capabilities, with children and young people playing an integral role in capability measure development. Drawing from existing literature, specific challenges related to the identification, measurement, and valuation of capabilities in children and young people are also discussed. Finally, the practical implications for conducting economic evaluation when measuring and valuing capabilities at different stages across the life-course are illustrated. We develop an alternative framework based on conceiving capabilities as evolving across the life-course. This framework may also be helpful in thinking about how to model health outcomes across the life-course.

Measuring capability wellbeing in adults at different stages of life for use in economic evaluation of health and care interventions: a qualitative investigation in people requiring kidney care.

PURPOSE: Capability wellbeing measures, such as the ICECAP measures, have been proposed for use in economic evaluations to capture broader outcomes of health and care interventions. The ICECAP measures have been developed to reflect capabilities at different stages of life. Some patient groups include patients of different ages and at different stages of life, so it is not always apparent which ICECAP measure is most relevant. This study explores the impact of age and life stage on completion, where both ICECAP-A and ICECAP-O were completed by the same patient. METHODS: A think-aloud study, and an associated semi-structured interview were conducted with people receiving kidney care as a renal outpatient, kidney transplant outpatient, or through receiving facility-based haemodialysis. Qualitative analysis focused on (1) differences in responses across measures by individuals, where attributes had conceptual overlap, (2) key factors in self-reported capability levels, and (3) measure preference. RESULTS: Thirty participants were included in the study, with a mix of older and younger adults. Attributes with similar wording across measures produced similar responses compared to attributes where wording differed. Age and health were key factors for self-reported capability levels. ICECAP-A was slightly preferred overall, including by older adults. CONCLUSION: This study suggests use of ICECAP-A in patients with certain chronic health conditions that include a mix of adults across the life course. This study highlights the importance of considering the stage of life when using capability measures and in economic evaluations of health and care interventions more generally.

Valuing end-of-life care: translation and content validation of the ICECAP-SCM measure.

BACKGROUND: The evaluation of care strategies at the end of life is particularly important due to the globally increasing proportion of very old people in need of care. The ICECAP-Supportive Care Measure is a self-complete questionnaire developed in the UK to evaluate palliative and supportive care by measuring patient's wellbeing in terms of 'capability'. It is a new measure with high potential for broad and international use. The aims of this study were the translation of the ICECAP-Supportive Care Measure from English into German and the content validation of this version. METHODS: A multi-step and team-based translation process based on the TRAPD model was performed. An expert survey was carried out to assess content validity. The expert panel (n = 20) consisted of four expert groups: representative seniors aged 65+, patients aged 65+ living in residential care, patients aged 65+ receiving end-of-life care, and professionals in end-of-life care. RESULTS: The German version of the ICECAP-Supportive Care Measure showed an excellent content validity on both item- and scale-level. In addition, a high agreement regarding the length of the single items and the total length of the questionnaire as well as the number of answer categories was reached. CONCLUSIONS: The German ICECAP-SCM is a valid tool to assess the quality of life at the end of life that is suitable for use in different settings. The questionnaire may be utilized in multinational clinical and economic evaluations of end-of-life care.

Cost and cost-effectiveness of a simplified treatment model with direct-acting antivirals for chronic hepatitis C in Cambodia.

BACKGROUND & AIMS: In 2016, Médecins Sans Frontières established the first general population Hepatitis C virus (HCV) screening and treatment site in Cambodia, offering free direct-acting antiviral (DAA) treatment. This study analysed the cost-effectiveness of this intervention. METHODS: Costs, quality adjusted life years (QALYs) and cost-effectiveness of the intervention were projected with a Markov model over a lifetime horizon, discounted at 3%/year. Patient-level resource-use and outcome data, treatment costs, costs of HCV-related healthcare and EQ-5D-5L health states were collected from an observational cohort study evaluating the effectiveness of DAA treatment under full and simplified models of care compared to no treatment; other model parameters were derived from literature. Incremental cost-effectiveness ratios (cost/QALY gained) were compared to an opportunity cost-based willingness-to-pay threshold for Cambodia ($248/QALY). RESULTS: The total cost of testing and treatment per patient for the full model of care was $925(IQR $668-1631), reducing to $376(IQR $344-422) for the simplified model of care. EQ-5D-5L values varied by fibrosis stage: decompensated cirrhosis had the lowest value, values increased during and following treatment. The simplified model of care was cost saving compared to no treatment, while the full model of care, although cost-effective compared to no treatment ($187/QALY), cost an additional $14 485/QALY compared to the simplified model, above the willingness-to-pay threshold for Cambodia. This result is robust to variation in parameters. CONCLUSIONS: The simplified model of care was cost saving compared to no treatment, emphasizing the importance of simplifying pathways of care for improving access to HCV treatment in low-resource settings.

Measuring Quality-Adjusted Life-Years When Health Fluctuates.

Recurrent fluctuations in health states can occur as a result of long-term conditions with episodic symptoms or through side effects of cycles of treatment. Fluctuations and associated duration of symptoms can be predictable (eg, side effects of chemotherapy treatment) or unpredictable (eg, relapse in multiple sclerosis). Such recurrent fluctuations in health states can have an important impact on a person's health-related quality of life. When symptoms vary by time of day, day of the week, or during the month, it is challenging to obtain reliable health-related quality of life estimates for use in assessing cost-effectiveness of interventions. The adequacy of the quality of life estimate will be affected by (1) the standard recall period associated with the chosen measure (eg, "health today" EQ-5D, "past 4 weeks" for SF-36/SF-6D) and the way that respondents understand and make judgments about these recall periods, (2) the chosen time points for assessing health-related quality of life in relation to the fluctuations in health, and (3) the assumptions used to interpolate between measurement time points and thus calculate the quality-adjusted life-years. These issues have not received sufficient methodological attention and instead remain poorly accounted for in economic analyses. There is potential for these issues to considerably distort treatment decisions away from the optimal allocation. This article brings together evidence from health economics, psychology, and behavioral economics to explore these challenges in depth; presents the solutions that have been applied to date; and details a methodological research agenda for measuring quality-adjusted life-years in recurrent fluctuating health states.

Capability instruments in economic evaluations of health-related interventions: a comparative review of the literature.

PURPOSE: Given increasing interest in using the capability approach for health economic evaluations and a growing literature, this paper aims to synthesise current information about the characteristics of capability instruments and their application in health economic evaluations. METHODS: A systematic literature review was conducted to assess studies that contained information on the development, psychometric properties and valuation of capability instruments, or their application in economic evaluations. RESULTS: The review identified 98 studies and 14 instruments for inclusion. There is some evidence on the psychometric properties of most instruments. Most papers found moderate-to-high correlation between health and capability measures, ranging between 0.41 and 0.64. ASCOT, ICECAP-A, -O and -SCM instruments have published valuation sets, most frequently developed using best-worst scaling. Thirteen instruments were originally developed in English and one in Portuguese; however, some translations to other languages are available. Ten economic evaluations using capability instruments were identified. The presentation of results show a lack of consensus regarding the most appropriate way to use capability instruments in economic evaluations with discussion about capability-adjusted life years (CALYs), years of capability equivalence and the trade-off between maximisation of capability versus sufficient capability. CONCLUSION: There has been increasing interest in applying the capability-based approach in health economic evaluations, but methodological and conceptual issues remain. There is still a need for direct comparison of the different capability instruments and for clear guidance on when and how they should be used in economic evaluations.

Exploring the costs, consequences and efficiency of three types of palliative care day services in the UK: a pragmatic before-and-after descriptive cohort study.

BACKGROUND: Palliative Care Day Services (PCDS) offer supportive care to people with advanced, progressive illness who may be approaching the end of life. Despite the growth of PCDS in recent years, evidence of their costs and effects is scarce. It is important to establish the value of such services so that health and care decision-makers can make evidence-based resource allocation decisions. This study examines and estimates the costs and effects of PCDS with different service configurations in three centres across the UK in England, Scotland and Northern Ireland. METHODS: People who had been referred to PCDS were recruited between June 2017 and September 2018. A pragmatic before-and-after descriptive cohort study design analysed data on costs and outcomes. Data on costs were collected on health and care use in the 4 weeks preceding PCDS attendance using adapted versions of the Client Service Receipt Inventory (CSRI). Outcomes, cost per attendee/day and volunteer contribution to PCDS were also estimated. Outcomes included quality of life (MQOL-E), health status (EQ-5D-5L) and capability wellbeing (ICECAP-SCM). RESULTS: Thirty-eight attendees were recruited and provided data at baseline and 4 weeks (centre 1: n = 8; centre 2: n = 8, centre 3: n = 22). The cost per attendee/day ranged from £121-£190 (excluding volunteer contribution) to £172-£264 (including volunteer contribution) across the three sites. Volunteering constituted between 28 and 38% of the total cost of PCDS provision. There was no significant mean change at 4 week follow-up from baseline for health and care costs (centre 1: £570, centre 2: -£1127, centre 3: £65), or outcomes: MQOL-E (centre 1: - 0.48, centre 2: 0.01, centre 3: 0.24); EQ-5D-5L (centre 1: 0.05, centre 2: 0.03, centre 3: - 0.03) and ICECAP-SCM (centre 1:0.00, centre 2: - 0.01, centre 3: 0.03). Centre costs variation is almost double per attendee when attendance rates are held constant in scenario analysis. CONCLUSIONS: This study highlights the contribution made by volunteers to PCDS provision. There is insufficient evidence on whether outcomes improved, or costs were reduced, in the three different service configurations for PCDS. We suggest how future research may overcome some of the challenges we encountered, to better address questions of cost-effectiveness in PCDS.

Appropriate frameworks for economic evaluation of end of life care: A qualitative investigation with stakeholders.

BACKGROUND: The use of quality-adjusted life years rests on the assertion that the objective of the health care system is to improve health. AIM: To elicit the views of expert stakeholders on the purpose and evaluation of supportive end of life care, and explore how different purposes of end of life care imply the need for different evaluative frameworks. DESIGN: Semi-structured qualitative interviews, analysed through an economic lens using a constant comparative approach. PARTICIPANTS: Twenty professionals working in or visiting the United Kingdom or Republic of Ireland, with clinical experience and/or working as academics in health-related disciplines. RESULTS: Four purposes of end of life care were identified from and are critiqued with the aid of the qualitative data: to improve health, to enable patients to die in their preferred place, to enable the patient to experience a good death, and to enable the patient to experience a good death, and those who are close to the patient to have an experience which is as free as possible from fear, stress and distress. CONCLUSION: Managing symptoms and reducing anxiety were considered to be core objectives of end of life care and fit with the wider health service objective of improving/maximising health. A single objective across the entire health system ensures consistency in the way that resource allocation is informed across that entire system. However, the purpose of care at the end of life is more complex, encompassing diverse and patient-centred objectives which we have interpreted as enabling the patient to experience a good death.

Developing a framework of quality indicators for healthcare business cases: a qualitative document analysis consolidating insight from expert guidance and current practice.

BACKGROUND: Business cases are used to provide a structured justification in favour of investing in new projects, services or interventions. Despite the use of business cases in determining how limited resources will be allocated within England's National Health Service (NHS), guidance concerning how to develop and evaluate business cases in the context of healthcare is inconstant and of varying relevance. This study aimed to develop a new framework of quality indicators for healthcare-related business cases by analysing the content of expert guidance documents and a sample of NHS business cases. METHODS: Qualitative document analysis was conducted on guidance documents (n = 7) and existing NHS business case documents (n = 18). Documents were purposefully sampled using criteria to ensure the framework reflected a diverse spread of expert opinion, and a varied sample of example business cases from current practice. Data were analysed using thematic and content analysis, and are presented in a visualised framework. RESULTS: Seven themes were identified within the qualitative document analysis (purpose, strategic priorities, options, benefits, costs, risks and evaluation). These themes were described and presented with a framework of quality indicators for healthcare-related business cases. CONCLUSION: To ou`r knowledge, this is the first framework of business case quality indicators designed specifically for use in a healthcare context. The framework presented in this study has implications for how business cases are developed and evaluated by decision makers. In the future it would be beneficial to investigate how the framework could be used in practice as a tool for critical appraisal.

Breaking bread: examining the impact of policy changes in access to state-funded provisions of gluten-free foods in England.

BACKGROUND: Coeliac disease affects approximately 1% of the population and is increasingly diagnosed in the United Kingdom. A nationwide consultation in England has recommend that state-funded provisions for gluten-free (GF) food should be restricted to bread and mixes but not banned, yet financial strain has prompted regions of England to begin partially or fully ceasing access to these provisions. The impact of these policy changes on different stakeholders remains unclear. METHODS: Prescription data were collected for general practice services across England (n = 7176) to explore changes in National Health Service (NHS) expenditure on GF foods over time (2012-2017). The effects of sex, age, deprivation and rurality on GF product expenditure were estimated using a multi-level gamma regression model. Spending rate within NHS regions that had introduced a 'complete ban' or a 'complete ban with age-related exceptions' was compared to spending in the same time periods amongst NHS regions which continued to fund prescriptions for GF products. RESULTS: Annual expenditure on GF products in 2012 (before bans were introduced in any area) was £25.1 million. Higher levels of GF product expenditure were found in general practices in areas with lower levels of deprivation, higher levels of rurality and higher proportions of patients aged under 18 and over 75. Expenditure on GF food within localities that introduced a 'complete ban' or a 'complete ban with age-related exceptions' were reduced by approximately 80% within the 3 months following policy changes. If all regions had introduced a 'complete ban' policy in 2014, the NHS in England would have made an annual cost-saving of £21.1 million (equivalent to 0.24% of the total primary care medicines expenditure), assuming no negative sequelae. CONCLUSIONS: The introduction of more restrictive GF prescribing policies has been associated with 'quick wins' for NHS regions under extreme financial pressure. However, these initial savings will be largely negated if GF product policies revert to recently published national recommendations. Better evidence of the long-term impact of restricting GF prescribing on patient health, expenses and use of NHS services is needed to inform policy.

Cost-effectiveness of internet-based training for primary care clinicians on antibiotic prescribing for acute respiratory tract infections in Europe.

Objectives: Overprescribing of antibiotics by general practitioners (GPs) is seen as a major driver of antibiotic resistance. Training in communication skills and C-reactive protein (CRP) testing both appear effective in reducing such prescribing. This study assesses the cost-effectiveness (compared with usual care) of: (i) training GPs in the use of CRP testing; (ii) training GPs in communication skills; and (iii) training GPs in both CRP testing and communication skills. Methods: Economic analyses [cost-utility analysis (CUA) accounting for the cost of antibiotic resistance and cost-effectiveness analysis (CEA)] were both conducted from a healthcare perspective with a time horizon of 28 days alongside a multinational, cluster, randomized, factorial controlled trial in patients with respiratory tract infections in five European countries. The primary outcome measures were QALYs and percentage reduction in antibiotic prescribing. Hierarchical modelling was used to estimate an incremental cost per QALY gained and an incremental cost per percentage reduction in antibiotic prescribing. Results: Overall, the results of both the CUA and CEA showed that training in communication skills is the most cost-effective option. However, excluding the cost of antibiotic resistance in the CUA resulted in usual care being the most cost-effective option. Country-specific results from the CUA showed that training in communication skills was cost-effective in Belgium, UK and Netherlands whilst training in CRP was cost-effective in Poland. Conclusions: Internet-based training in communication skills is a cost-effective intervention to reduce antibiotic prescribing for respiratory tract infections in primary care if the cost of antibiotic resistance is accounted for.

Cost-effectiveness of prostate cancer screening: a systematic review of decision-analytical models.

BACKGROUND: There is ongoing debate about the harms and benefits of a national prostate cancer screening programme. Several model-based cost-effectiveness analyses have been developed to determine whether the benefits of prostate cancer screening outweigh the costs and harms caused by over-detection and over-treatment, and the different approaches may impact results. METHODS: To identify models of prostate cancer used to assess the cost-effectiveness of prostate cancer screening strategies, a systematic review of articles published since 2006 was conducted using the NHS Economic Evaluation Database, Medline, EMBASE and HTA databases. The NICE website, UK National Screening website, reference lists from relevant studies were also searched and experts contacted. Key model features, inputs, and cost-effectiveness recommendations were extracted. RESULTS: Ten studies were included. Four of the studies identified some screening strategies to be potentially cost-effective at a PSA threshold of 3.0 ng/ml, including single screen at 55 years, annual or two yearly screens starting at 55 years old, and delayed radical treatment. Prostate cancer screening was modelled using both individual and cohort level models. Model pathways to reflect cancer progression varied widely, Gleason grade was not always considered and clinical verification was rarely outlined. Where quality of life was considered, the methods used did not follow recommended practice and key issues of overdiagnosis and overtreatment were not addressed by all studies. CONCLUSION: The cost-effectiveness of prostate cancer screening is unclear. There was no consensus on the optimal model type or approach to model prostate cancer progression. Due to limited data availability, individual patient-level modelling is unlikely to increase the accuracy of cost-effectiveness results compared with cohort-level modelling, but is more suitable when assessing adaptive screening strategies. Modelling prostate cancer is challenging and the justification for the data used and the approach to modelling natural disease progression was lacking. Country-specific data are required and recommended methods used to incorporate quality of life. Influence of data inputs on cost-effectiveness results need to be comprehensively assessed and the model structure and assumptions verified by clinical experts.