Public versus patient health preferences: protocol for a study to elicit EQ-5D-5L health state valuations for patients who have survived a stay in intensive care.

INTRODUCTION: The value set used when calculating quality-adjusted life-years (QALYs) is most often based on stated preference data elicited from a representative sample of the general population. However, having a severe disease may alter a person's health preferences, which may imply that, for some patient groups, experienced QALYs may differ from those that are estimated via standard methods. This study aims to model 5-level EuroQol 5-dimensional questionnaire (EQ-5D-5L) valuations based on preferences elicited from a sample of patients who have survived a stay in a Danish intensive care unit (ICU) and to compare these with the preferences of the general population. Further, the heterogeneity in the ICU patients' preferences will be investigated. METHODS AND ANALYSIS: This valuation study will elicit EQ-5D-5L health state preferences from a sample of 300 respondents enrolled in two randomised controlled trials at Danish ICUs. Patients' preferences will be elicited using composite time trade-off based on the EuroQol Valuation Technology, the same as that used to generate the EQ-5D-5L value set for the Danish general population. The patient-based and the public-based EQ-5D-5L valuations will be compared. Potential underlying determinants of the ICU preferences will be investigated through analyses of demographic characteristics, time since the ICU stay, self-reported health, willingness to trade-off length of life for quality of life, health state reference dependency and EQ-5D dimensions that patients have experienced themselves during their illness. ETHICS AND DISSEMINATION: Under Danish regulations, ethical approval is not required for studies of this type. Written informed consent will be obtained from all patients. The study results will be published in peer-reviewed scientific journals and presented at national and international conferences. The modelling algorithms will be publicly available for statistical software, such as Stata and R.

A cost-minimisation analysis of performing point-of-care ultrasonography on patients with vaginal bleeding in early pregnancy in general practice: a decision analytical model.

BACKGROUND: Spotting and light vaginal bleeding are common and usually harmless symptoms in early pregnancy. Still, vaginal bleeding may be the first sign of an abortion and often causes distress to pregnant women and leads to an expectation of an ultrasonography examination of the uterus. As point-of-care ultrasonography (POCUS) is increasingly being integrated into general practice, these patients may be clinically evaluated and managed by general practitioners (GPs). This can potentially reduce referrals of patients from the primary to the secondary healthcare sector resulting in societal cost-savings. The primary purpose of this study was to investigate whether the accessibility of POCUS in general practice for patients with vaginal bleeding in early pregnancy is cost-saving compared to usual practice where GPs do not have access to POCUS. A secondary purpose of this study was to estimate a remuneration for GPs performing POCUS on these patients in general practice. METHODS: A cost-minimisation analysis was based on a decision tree model reflecting the two alternatives: general practice with and without GPs having access to POCUS. The robustness of the model results was investigated using probabilistic sensitivity analysis and the following deterministic sensitivity analyses: one-way analyses for the model input parameters and a scenario analysis with a change from a societal to a healthcare sector perspective. An expected remuneration reflecting the add-on cost of Danish GPs performing POCUS was estimated based on the related costs: cost of an ultrasonography scanner, GP's time consumption, ultrasonography training, and utensils per scanning. RESULTS: The difference in average cost between the two alternatives from a societal perspective was estimated to be €110, in favour of general practice with GPs using POCUS. The deterministic sensitivity analyses demonstrated robustness of the results to plausible changes in the input parameters. The expected remuneration for performing POCUS in this specific setting was estimated to be €32 per examination. CONCLUSION: Having GPs perform POCUS on patients with vaginal bleeding in early pregnancy is cost-saving compared to usual practice. The results should be taken with caution as this study was based on early modelling with uncertainties associated with the input parameters in the model.

The Danish EQ-5D-5L Value Set: A Hybrid Model Using cTTO and DCE Data.

OBJECTIVES: Quality-adjusted life-years (QALYs) are expected to be used for priority setting of hospital-dispensed medicines in Denmark from 2021. The aim of this study was to develop the first Danish value set for the EQ-5D-5L based on interviews with a representative sample of the Danish adult population. METHODS: A nationally representative sample based on age (> 18 years), gender, education, and geographical region was recruited using data provided by Statistics Denmark. Computer-assisted personal interviews were carried out using the EQ-VT 2.1. Respondents each valued ten health states using composite time trade-off (cTTO) and seven health states using discrete-choice experiment (DCE). Different predictive models were explored using cTTO and DCE data alone or in combination as hybrid models. Model performance was assessed using logical consistency. RESULTS: A total of 1014 interviews were included in the analyses. The sample was representative of the Danish adult population, though the sample contained slightly more respondents with higher education than in the general population. Only the heteroscedastic censored hybrid model combining cTTO and DCE data yielded consistent results, and hence was chosen for modelling the final Danish value set. The predicted values ranged from - 0.757 to 1, and anxiety/depression was the dimension assigned most value by respondents. CONCLUSIONS: This study established the Danish EQ-5D-5L value set, which represents the preferences of the Danish general population, and is expected to provide key input for healthcare decision-making in a Danish context.

Mapping Dermatology Life Quality Index (DLQI) scores to EQ-5D utility scores using data of patients with atopic dermatitis from the National Health and Wellness Study.

PURPOSE: To develop a mapping algorithm for generating EQ-5D-5-level (EQ-5D-5L) utility scores from the Dermatology Life Quality Index (DLQI) in patients with atopic dermatitis (AD). METHODS: The algorithm was developed using data from 1232 patients from four countries participating in the National Health and Wellness Study. Spearman's rank correlation coefficient was used to evaluate the conceptual overlap between DLQI and EQ-5D-5L. Six mapping models (ordinary least squares [OLS], Tobit, three different two-part models, and a regression mixture model) were tested with different specifications to determine model performance and were ranked based on the sum of mean absolute error (MAE), and root mean squared error (RMSE). RESULTS: The mean DLQI score was 7.23; mean EQ-5D-5L score was 0.78; and there were moderate negative correlations between DLQI and EQ-5D-5L scores (p = - 0.514). A regression mixture model with total DLQI, and age and sex as independent variables performed best for mapping DLQI to EQ-5D-5L (RMSE = 0.113; MAE = 0.079). CONCLUSION: This was the first study to map DLQI to EQ-5D-5L exclusively in patients with AD. The regression mixture model with total DLQI, and age and sex as independent variables was the best performing model and accurately predicted EQ-5D-5L. The results of this mapping can be used to translate DLQI data from clinical studies to health state utility values in economic evaluations.

Predictive ability of the start back tool: an ancillary analysis of a low back pain trial from Danish general practice.

BACKGROUND: Low back pain (LBP) is a common cause of contact with the primary healthcare sector. In some patients, symptoms quickly resolve, but others develop long-lasting pain and disability. To improve the care pathway for patients with LBP, the STarT Back Tool (STarT) questionnaire has been developed. It helps initial decision-making by subgrouping patients on the basis of their prognosis and helps to target treatment according to prognosis. An assumption behind the use of STarT is the ability to predict functional improvement. This assumption has never been tested in a population that consists exclusively of patients enrolled when consulting a Danish general practitioner for LBP. The aim of this study was to investigate STarT's ability to predict a 30% improvement in the Roland Morris Disability Questionnaire (RMDQ) score. METHODS: This was an ancillary analysis using data from a Danish guideline implementation study (registered at ClinicalTrials.gov NCT01699256). An inclusion criterion was age 18 to 65 years of age. Exclusion criteria were pregnancy, fractures, and signs of underlying pathology. Patient-reported STarT score and the Roland Morris Disability Questionnaire were administered at baseline and again after 4, 8, and 52 weeks. RESULTS: Between January 2013 and July 2014, 475 patients from the original trial participated with questionnaires. From this subpopulation, 441 (92.8%) patients provided information regarding STarT. Baseline and eight-week RMDQ data were available for 304 (64.0%) patients. After 8 weeks, 61 (65.6%) in the low-risk group, 67 (54.9%) in the medium-risk group, and 33 (37.1%) in the high-risk group had achieved a 30% improvement in the RMDQ score. After 8 weeks, high-risk patients were at 61% (95% CI: 20-125%, P < 0.001) higher risk of not achieving a 30% improvement in the RMDQ score compared with patients in either the low-risk group or the medium-risk group. CONCLUSION: STarT was predictive for functional improvement in patients from general practice with LBP. TRIAL REGISTRATION: ClinicalTrials.gov NCT01699256 , Nov 29, 2016 (registered retrospectively).

Economic evaluation of an implementation strategy for the management of low back pain in general practice.

In connection with the publication of a clinical practice guideline on the management of low back pain (LBP) in general practice in Denmark, a cluster randomised controlled trial was conducted. In this trial, a multifaceted guideline implementation strategy to improve general practitioners' treatment of patients with LBP was compared with a usual implementation strategy. The aim was to determine whether the multifaceted strategy was cost effective, as compared with the usual implementation strategy. The economic evaluation was conducted as a cost-utility analysis where cost collected from a societal perspective and quality-adjusted life years were used as outcome measures. The analysis was conducted as a within-trial analysis with a 12-month time horizon consistent with the follow-up period of the clinical trial. To adjust for a priori selected covariates, generalised linear models with a gamma family were used to estimate incremental costs and quality-adjusted life years. Furthermore, both deterministic and probabilistic sensitivity analyses were conducted. Results showed that costs associated with primary health care were higher, whereas secondary health care costs were lower for the intervention group when compared with the control group. When adjusting for covariates, the intervention was less costly, and there was no significant difference in effect between the 2 groups. Sensitivity analyses showed that results were sensitive to uncertainty. In conclusion, the multifaceted implementation strategy was cost saving when compared with the usual strategy for implementing LBP clinical practice guidelines in general practice. Furthermore, there was no significant difference in effect, and the estimate was sensitive to uncertainty.

A multifaceted implementation strategy versus passive implementation of low back pain guidelines in general practice: a cluster randomised controlled trial.

BACKGROUND: Guidelines are often slowly adapted into clinical practice. However, actively supporting healthcare professionals in evidence-based treatment may speed up guideline implementation. Danish low back pain (LBP) guidelines focus on primary care treatment of LBP, to reduce referrals from primary care to secondary care. The primary aim of this project was to reduce secondary care referral within 12 weeks by a multifaceted implementation strategy (MuIS). METHODS: In a cluster randomised design, 189 general practices from the North Denmark Region were invited to participate. Practices were randomised (1:1) and stratified by practice size to MuIS (28 practices) or a passive implementation strategy (PaIS; 32 practices). Included were patients with LBP aged 18 to 65 years who were able to complete questionnaires, had no serious underlying pathology, and were not pregnant. We developed a MuIS including outreach visits, quality reports, and the STarT Back Tool for subgrouping patients with LBP. Both groups were offered the usual dissemination of guidelines, guideline-concordant structuring of the medical record, and a new referral opportunity for patients with psycho-social problems. In an intention-to-treat analysis, the primary and secondary outcomes pertained to the patient, and a cost-effectiveness analysis was performed from a healthcare sector perspective. Patients and the assessment of outcomes were blinded. Practices and caregivers delivering the interventions were not blinded. RESULTS: Between January 2013 and July 2014, 60 practices were included, of which 54 practices (28 MuIS, 26 PaIS) included 1101 patients (539 MuIS, 562 PaIS). Follow-up data for the primary outcome were available on 100 % of these patients. Twenty-seven patients (5.0 %) in the MuIS group were referred to secondary care vs. 59 patients (10.5 %) in the PaIS group. The adjusted odds ratio (AOR) was 0.52 [95 % CI 0.30 to 0.90; p = 0.020]. The MuIS was cost-saving £-93.20 (£406.51 vs. £499.71 per patient) after 12 weeks. Conversely, the MuIS resulted in less satisfied patients after 52 weeks (AOR 0.50 [95 % CI 0.31 to 0.81; p = 0.004]). CONCLUSIONS: Using a MuIS changed general practice referral behaviour and was cost effective, but patients in the MuIS group were less satisfied. This study supports the application of a MuIS when implementing guidelines. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01699256.

Systematic review of the cost-effectiveness of implementing guidelines on low back pain management in primary care: is transferability to other countries possible?

OBJECTIVE: The primary aim is to identify, summarise and quality assess the available literature on the cost-effectiveness of implementing low back pain guidelines in primary care. The secondary aim is to assess the transferability of the results to determine whether the identified studies can be included in a comparison with a Danish implementation study to establish which strategy procures most value for money. DESIGN: Systematic review. DATA SOURCES: The search was conducted in Embase, PubMed, Cochrane Library, NHS Economic Evaluation Database, Scopus, CINAHL and EconLit. No restrictions were made concerning language, year of publication or publication type. The bibliographies of the included studies were searched for any studies not captured in the literature search. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: To be included, a study must be: (1) based on a randomised controlled trial comparing implementation strategies, (2) the guideline must concern treatment of low back pain in primary care and (3) the economic evaluation should contain primary data on cost and cost-effectiveness. RESULTS: The title and abstract were assessed for 308 studies; of these, three studies were found eligible for inclusion. The Consensus Health Economic Criteria (CHEC) list showed that the 3 studies were of moderate methodological quality while application of Welte's model showed that cost results from two studies could, with adjustments, be transferred to a Danish setting. It was questionable whether the associated effects could be transferred. CONCLUSIONS: Despite the resemblance of the implementation strategies, the 3 studies report conflicting results on cost-effectiveness. This review showed that transferring the results from the identified studies is not straightforward and underlines the importance of transparent reporting. Future research should focus on transferability of effects, for example, development of a supplement to Welte's model.

Study protocol of an economic evaluation of an extended implementation strategy for the treatment of low back pain in general practice: a cluster randomised controlled trial.

BACKGROUND: In Denmark, guidelines on low back pain management are currently being implemented; in association with this, a clinical trial is conducted. A health economic evaluation is carried out alongside the clinical trial to assess the cost-effectiveness of an extended implementation strategy to increase the general practitioners' adherence to the guidelines. In addition to usual dissemination, the extended implementation strategy is composed of visits from a guideline facilitator, stratification tools, and feedback on guideline adherence. The aim of this paper is to provide the considerations on the design of the health economic evaluation. METHODS/DESIGN: The economic evaluation is carried out alongside a cluster randomised controlled trial consisting of 60 general practices in the North Denmark Region. An expected 1,200 patients between the age of 18 and 65 years with a low back pain diagnosis will be enrolled. The economic evaluation comprises both a cost-effectiveness analyses and a cost-utility analysis. Effectiveness measures include referral to secondary care, health-related quality of life measured by EQ-5D-5L, and disability measured by the Roland Morris disability questionnaire. Cost measures include all relevant additional costs of the extended implementation strategy compared to usual implementation. The economic evaluation will be performed from both a societal perspective and a health sector perspective with a 12-month time horizon. DISCUSSION: It is expected that the extended implementation strategy will reduce the number of patients referred to secondary care. It is hypothesised that the additional upfront cost of extended implementation will be counterbalanced by improvements in clinical practice and patient-related outcomes, thereby rendering the extended implementation strategy cost-effective. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01699256.

In Denmark kidney transplantation is more cost-effective than dialysis.

INTRODUCTION: Approximately 5,000 Danish patients are being treated for end-stage renal disease, for which the two treatment options are dialysis and transplantation. The objective of this study was to estimate the cost-effectiveness of kidney transplantation versus dialysis from a public health-care perspective. MATERIAL AND METHODS: A cost-utility analysis was conducted using a decision analytic model. The model was designed as a Markov model in which all relevant costs and effects of the two alternative treatments were included. Deterministic data were used alongside the best available evidence from the literature. To estimate the overall uncertainty concerning the incremental cost-effectiveness ratio (ICER), a probabilistic sensitivity analysis with second-order Monte Carlo simulations was carried out on a hypothetical cohort of 10,000 patients. RESULTS: The cost per quality-adjusted life year (QALY) was 1,032,934 DKK for dialysis compared with 810,516 DKK for transplantation. When comparing kidney transplantation with dialysis, kidney transplantation was cost-saving and resulted in additional QALYs. When taking the overall uncertainty associated with the ICER into account, an incremental cost-effectiveness scatter plot supported that transplantation was dominating and that the results were robust. In addition, a cost-effectiveness acceptability curve showed that transplantation had a 99.93% likelihood of being cost-effective at a willingness-to-pay value of 0 DKK. CONCLUSION: The cost-effectiveness ratio was favourable for kidney transplantation when compared with dialysis. In view of this, it was concluded that transplantation is preferable to dialysis when treating patients with end-stage renal disease. FUNDING: not relevant. TRIAL REGISTRATION: not relevant.

Enhanced implementation of low back pain guidelines in general practice: study protocol of a cluster randomised controlled trial.

BACKGROUND: Evidence-based clinical practice guidelines may improve treatment quality, but the uptake of guideline recommendations is often incomplete and slow. Recently new low back pain guidelines are being launched in Denmark. The guidelines are considered to reduce personal and public costs. The aim of this study is to evaluate whether a complex, multifaceted implementation strategy of the low back pain guidelines will reduce secondary care referral and improve patient outcomes compared to the usual simple implementation strategy. METHODS/DESIGN: In a two-armed cluster randomised trial, 100 general practices (clusters) and 2,700 patients aged 18 to 65 years from the North Denmark region will be included. Practices are randomly allocated 1:1 to a simple or a complex implementation strategy. Intervention practices will receive a complex implementation strategy, including guideline facilitator visits, stratification tools, and quality reports on low back pain treatment. Primary outcome is referral to secondary care. Secondary outcomes are pain, physical function, health-related quality of life, patient satisfaction with care and treatment outcome, employment status, and sick leave. Primary and secondary outcomes pertain to the patient level. Assessments of outcomes are blinded and follow the intention-to-treat principle. Additionally, a process assessment will evaluate the degree to which the intervention elements will be delivered as planned, as well as measure changes in beliefs and behaviours among general practitioners and patients. DISCUSSION: This study provides knowledge concerning the process and effect of an intervention to implement low back pain guidelines in general practice, and will provide insight on essential elements to include in future implementation strategies in general practice. TRIAL REGISTRATION: Registered as NCT01699256 on ClinicalTrials.gov.