Economic Evaluation of a Mobile Stroke Unit Service in Germany.

BACKGROUND: Lower global disability and higher quality of life among ischemic stroke patients was found to be associated with the dispatch of mobile stroke units (MSUs) among patients eligible for recanalizing treatments in the Berlin_Prehospital Or Usual Delivery of stroke care (B_PROUD) study. The current study assessed the cost-utility and cost-effectiveness of additional MSU dispatch using data from this prospective, controlled, intervention study. METHODS: Outcomes considered in the economic evaluation included quality-adjusted life years (QALYs) derived from the 3-level version of EQ-5D (EQ-5D-3L) and modified Rankin Scale (mRS) scores for functional outcomes 3-months after stroke. Costs were prospectively collected during the study by the MSU provider (Berlin Fire Brigade) and the B_PROUD research team. We focus our results on the societal perspective. As we aimed to determine the economic consequences of the intervention beyond the study's follow-up period, both care costs and QALYs were extrapolated over 5 years. RESULTS: The additional MSU dispatch resulted in an incremental €40,984 per QALY. The best-case scenario and the worst-case scenario yielded additional costs of, respectively, €24,470.76 and €61,690.88 per QALY. In the cost-effectiveness analysis, MSU dispatch resulted in incremental costs of €81,491 per survival without disability. The best-case scenario and the worst-case scenario yielded additional costs of, respectively, €44,455.30 and €116,491.15 per survival without disability. INTERPRETATION: Among patients eligible for recanalizing treatments in ischemic stroke, MSU dispatch was associated with both higher QALYs and higher costs and is cost-effective when considering internationally accepted thresholds ranging from an additional €40,000 to €80,000 per QALY. ANN NEUROL 2023;93:942-951.

Mapping Studies to Estimate Health-State Utilities From Nonpreference-Based Outcome Measures: A Systematic Review on How Repeated Measurements are Taken Into Account.

OBJECTIVES: Mapping algorithms are developed using data sets containing patient responses to a preference-based questionnaire and another health-related quality-of-life questionnaire. When data sets include repeated measurements from the same individuals over time, the assumption of observations' independence, required by standard models, is violated, and standard errors are underestimated. This review aimed to identify how studies deal with methodological challenges of repeated measurements, provide an overview of practice to date, and potential implications for future work. METHODS: We conducted a systematic literature search of MEDLINE, Cumulative Index to Nursing and Allied Health Literature, specialized databases, and previous systematic reviews. A data template was used to extract, among others, start and target instruments if the data set(s) used for estimation and validation had repeated measurements per patient, used regression techniques, and which (if any) adjustments were made for repeated measurements. RESULTS: We identified 278 publications developing at least 1 mapping algorithm. Of the 278 publications, 121 used a data set with repeated measurements, among which 92 used multiple time points for estimation, and 39 selected specific time points to have 1 observation per participant. A total of 36 studies did not account for repeated measurements. An adjustment was conducted using cluster-robust standard errors (21), random-effects models (30), generalized estimating equations (7), and other methods (7). CONCLUSIONS: The inconsistent use of methods to account for interdependent observations in the literature indicates that mapping guidelines should include recommendations on how to deal with repeated measurements, and journals should update their guidelines accordingly.

Study Design and Protocol of a Randomized Controlled Trial of the Efficacy of a Smartphone-Based Therapy of Migraine (SMARTGEM).

Background: Digitalization and electronic health (eHealth) offer new treatment approaches for patients with migraine. Current smartphone applications (apps) for migraine patients include a wide spectrum of functions ranging from digital headache diaries to app-based headache treatment by, among others, analysis of the possible triggers, behavioral therapy approaches and prophylactic non-drug treatment methods with relaxation therapy or endurance sport. Additional possibilities arise through the use of modern, location-independent communication methods, such as online consultations. However, there is currently insufficient evidence regarding the benefits and/or risks of these electronic tools for patients. To date, only few randomized controlled trials have assessed eHealth applications. Methods: SMARTGEM is a randomized controlled trial assessing whether the provision of a new digital integrated form of care consisting of the migraine app M-sense in combination with a communication platform (with online consultations and medically moderated patient forum) leads to a reduction in headache frequency in migraine patients, improving quality of life, reducing medical costs and work absenteeism (DRKS-ID: DRKS00016328). Discussion: SMARTGEM constitutes a new integrated approach for migraine treatment, which aims to offer an effective, location-independent, time-saving and cost-saving treatment. The design of the study is an example of how to gather high quality evidence in eHealth. Results are expected to provide insightful information on the efficacy of the use of electronic health technology in improving the quality of life in patients suffering from migraine and reducing resource consumption.

HIT-6 and EQ-5D-5L in patients with migraine: assessment of common latent constructs and development of a mapping algorithm.

OBJECTIVE: The aims of this study were to assess whether there is a conceptual overlap between the questionnaires HIT-6 and EQ-5D and to develop a mapping algorithm allowing the conversion of HIT-6 to EQ-5D utility scores for Germany. METHODS: This study used data from an ongoing randomised controlled trial for patients suffering from migraine. We assessed the conceptual overlap between the two instruments with correlation matrices and exploratory factor analysis. Linear regression, tobit, mixture, and two-part models were used for mapping, accounting for repeated measurements, tenfold cross-validation was conducted to validate the models. RESULTS: We included 1010 observations from 410 patients. The EQ-5D showed a substantial ceiling effect (47.3% had the highest score) but no floor effect, while the HIT-6 showed a very small ceiling effect (0.5%). The correlation between the instruments' total scores was moderate (- 0.30), and low to moderate among each domain (0.021-0.227). The exploratory factor analysis showed insufficient conceptual overlap between the instruments, as they load on different factors. Thus, there is reason to believe that the instruments' domains do not capture the same latent constructs. To facilitate future mapping, we provide coefficients and a variance-covariance matrix for the preferred model, a two-part model with the total HIT-6 score as the explanatory variable. CONCLUSION: This study showed that the German EQ-5D and the HIT-6 lack the conceptual overlap needed for appropriate mapping. Thus, the estimated mapping algorithms should only be used as a last resort for estimating utilities to be employed in economic evaluations.

Determining the Evolution of Headache Among Regular Users of a Daily Electronic Diary via a Smartphone App: Observational Study.

BACKGROUND: Smartphone-based apps represent a major development in health care management. Specifically in headache care, the use of electronic headache diaries via apps has become increasingly popular. In contrast to the soaring volume of available data, scientific use of these data resources is sparse. OBJECTIVE: In this analysis, we aimed to assess changes in headache and migraine frequency, headache and migraine intensity, and use of acute medication among people who showed daily use of the headache diary as implemented in the freely available basic version of the German commercial app, M-sense. METHODS: The basic version of M-sense comprises an electronic headache diary, documentation of lifestyle factors with a possible impact on headaches, and evaluation of headache patterns. This analysis included all M-sense users who had entered data into the app on a daily basis for at least 7 months. RESULTS: We analyzed data from 1545 users. Mean MHD decreased from 9.42 (SD 5.81) at baseline to 6.39 (SD 5.09) after 6 months (P<.001; 95% CI 2.80-3.25). MMD, AMD, and migraine intensity were also significantly reduced. Similar results were found in 985 users with episodic migraine and in 126 users with chronic migraine. CONCLUSIONS: Among regular users of an electronic headache diary, headache and migraine frequency, in addition to other headache characteristics, improved over time. The use of an electronic headache diary may support standard headache care.

Primary headaches during the COVID-19 lockdown in Germany: analysis of data from 2325 patients using an electronic headache diary.

BACKGROUND: Lockdown measures due to the COVID-19 pandemic have led to lifestyle changes, which in turn may have an impact on the course of headache disorders. We aimed to assess changes in primary headache characteristics and lifestyle factors during the COVID-19 lockdown in Germany using digital documentation in the mobile application (app) M-sense. MAIN BODY: We analyzed data of smartphone users, who entered daily data in the app in the 28-day period before lockdown (baseline) and in the first 28 days of lockdown (observation period). This analysis included the change of monthly headache days (MHD) in the observation period compared to baseline. We also assessed changes in monthly migraine days (MMD), the use of acute medication, and pain intensity. In addition, we looked into the changes in sleep duration, sleep quality, energy level, mood, stress, and activity level. Outcomes were compared using paired t-tests. The analysis included data from 2325 app users. They reported 7.01 ± SD 5.64 MHD during baseline and 6.89 ± 5.47 MHD during lockdown without significant changes (p > 0.999). MMD, headache and migraine intensity neither showed any significant changes. Days with acute medication use were reduced from 4.50 ± 3.88 in the baseline to 4.27 ± 3.81 in the observation period (p < 0.001). The app users reported reduced stress levels, longer sleep duration, reduced activity levels, along with a better mood, and an improved energy level during the first lockdown month (p ≤ 0.001). In an extension analysis of users who continued to use M-sense every day for 3 months after initiation of lockdown, we compared the baseline and the subsequent months using repeated-measures ANOVA. In these 539 users, headache frequency did not change significantly neither (6.11 ± 5.10 MHD before lockdown vs. 6.07 ± 5.17 MHD in the third lockdown month, p = 0.688 in the ANOVA). Migraine frequency, headache and migraine intensity, and acute medication use were also not different during the entire observation period. CONCLUSION: Despite slight changes in factors that contribute to the generation of headache, COVID-19-related lockdown measures did not seem to be associated with primary headache frequency and intensity over the course of 3 months.

Patients prefer clinical handover at the bedside; nurses do not: Evidence from a discrete choice experiment.

BACKGROUND: Shift-to-shift bedside handover is advocated as a patient-centred approach, yet its enactment is challenging. OBJECTIVES: To describe and compare the preferences of both patients and nurses in the implementation of bedside handover in a Swedish University Hospital. DESIGN: A discrete choice experiment (DCE) survey. SETTINGS: University setting, four medical wards in two hospitals. PARTICIPANTS: Adult medical patients (n = 218) and registered nurses (n = 101) METHODS: The survey was administered by an electronic tablet-assisted face-to-face survey. Respondents made repeated choices between two hypothetical bedside handover alternatives and a third alternative of 'handover away from the bedside'. Handover alternatives were described according to six attributes: invitation to participate, number of nurses present at the handover, family member, carer or trusted friend (of the patient) allowed to be present, level of (patient) involvement, what information related to your (patient) care is discussed. Choice data were analyzed using a mixed logit model. RESULTS: A total of 1308 (patients) and 909 (nurses) choice observations were included in the preference models. Patients showed a strong preference for handover at the bedside compared to nurses. Nurses generally preferred handover away from the bedside. Patients perceived their level of involvement in handover as highly important, being able to speak, hear what was said being the most important characteristic, closely followed by being invited to participate and asked questions as well as being heard. Nurses considered patients being invited to participate most important, followed by level of involvement. Different options for handing over sensitive information were not perceived of importance by patients or nurses. There was substantial variation at the individual level across both patients and nurses for where and how handover is delivered. CONCLUSIONS: In this study, patients strongly preferred handover at the bedside, while the nurses considered patients to be invited to participate to be the most important preference but generally preferred handover to take place away from the bedside, all else equal. When implementing bedside handover in a Swedish context this must be considered, although participation is a prerequisite for bedside handover. Differences between patients and nurses' preferences could jeopardize future introduction of bedside handover in Swedish health care, and might explain why bedside handover is still not very common in hospital wards.

Cost-minimisation analysis alongside a pilot study of early Tissue Doppler Evaluation of Diastolic Dysfunction in Emergency Department Non-ST Elevation Acute Coronary Syndromes (TEDDy-NSTEACS).

OBJECTIVE: To estimate the cost implications of early angiography for patients with suspected non-ST elevation acute coronary syndrome (NSTEACS) using tissue Doppler imaging (TDI). DESIGN: A decision tree model was used to synthesise data from the pilot study and literature sources. Sensitivity analyses tested the impact of assumptions incorporated into the analysis. SETTING: Emergency department (ED), Brisbane, Australia. PARTICIPANTS: Patients with suspected NSTEACS. INTERVENTIONS: TDI as a diagnostic tool for triaging patients within 4 hours of presentation in addition to conventional risk stratification, compared with conventional risk stratification alone. DATA SOURCES: Resource used for diagnosis and management were recorded prospectively and costed for 51 adults who had echocardiography within 24 hours of admission. Costs for conventional care were based on observed data. Cost estimates for the TDI intervention assumed patients classified as high risk at TDI (E/e'>14) progressed early to angiography with an associated 1-day reduction in length of stay. PRIMARY OUTCOME MEASURES: Costs until discharge from the Australian healthcare perspective in 2016-2017 prices. RESULTS: Findings suggest that using TDI as a diagnostic tool for triaging patients with suspected NSTEACS is likely to be cost saving by $A1090 (95% credible interval: $A573 to $A1703) per patient compared with conventional care. The results are mainly driven by the assumed reduction in length of stay due to the inclusion of early TDI in clinical decision-making. CONCLUSIONS: This pilot study indicates that compared with conventional risk stratification, triaging patients presenting with suspected NSTEACS with TDI within 4 hours of ED presentation has potential cost savings. Findings assume a reduction in hospital stay is achieved for patients considered to be high risk at TDI. Larger, comparative studies with longer follow-up are needed to confirm the clinical effectiveness of TDI as a diagnostic strategy for NSTEACS, the assumed reduction in hospital stay and any cost saving.

Preferences for the administration of testosterone gel: evidence from a discrete choice experiment.

Objectives: Differences in testosterone replacement therapy (TRT) gel products may affect patient satisfaction, quality-of-life, and treatment response and adherence. This study investigated preferences for TRT gel in terms of formulation and administration. Methods: 525 male adults aged 45 years and over completed a discrete choice experiment. Respondents made repeated choices between two hypothetical testosterone gel treatments described according to four attributes: form, ease of use, impact of use on showering/swimming, and location/dosage of the application. Choice data were analyzed using a latent class model. Results: Three preference classes were identified. Respondents across all classes displayed a preference for the gel being dispensed in smaller units with accurate dosing, waiting shorter times after the gel application before swimming/showering, and using 2.5 gm of gel to be applied to the inner thigh/abdomen as opposed 5 gm to shoulder/abdomen. The importance of these characteristics differed across classes, with preference class membership predicted by age and education level. For instance, younger men (aged 45-64 years) were more likely to belong to a class that prioritized reduced waiting time before being able to undertake activities. Formulation was not an important driver of choice. Conclusions: Preferences demonstrate a predilection for TRT gel dispensed in small units allowing precise dosing, shorter waiting time after application, and application to the inner thigh/abdomen. However, the strength of importance of these characteristics differs between men. This study highlights the attributes of TRT gel considered important to patient subgroups, and which may ultimately affect treatment response, medication adherence, and patient quality-of-life.

A Systematic Review Comparing the Acceptability, Validity and Concordance of Discrete Choice Experiments and Best-Worst Scaling for Eliciting Preferences in Healthcare.

OBJECTIVE: The aim of this study was to compare the acceptability, validity and concordance of discrete choice experiment (DCE) and best-worst scaling (BWS) stated preference approaches in health. METHODS: A systematic search of EMBASE, Medline, AMED, PubMed, CINAHL, Cochrane Library and EconLit databases was undertaken in October to December 2016 without date restriction. Studies were included if they were published in English, presented empirical data related to the administration or findings of traditional format DCE and object-, profile- or multiprofile-case BWS, and were related to health. Study quality was assessed using the PREFS checklist. RESULTS: Fourteen articles describing 12 studies were included, comparing DCE with profile-case BWS (9 studies), DCE and multiprofile-case BWS (1 study), and profile- and multiprofile-case BWS (2 studies). Although limited and inconsistent, the balance of evidence suggests that preferences derived from DCE and profile-case BWS may not be concordant, regardless of the decision context. Preferences estimated from DCE and multiprofile-case BWS may be concordant (single study). Profile- and multiprofile-case BWS appear more statistically efficient than DCE, but no evidence is available to suggest they have a greater response efficiency. Little evidence suggests superior validity for one format over another. Participant acceptability may favour DCE, which had a lower self-reported task difficulty and was preferred over profile-case BWS in a priority setting but not necessarily in other decision contexts. CONCLUSION: DCE and profile-case BWS may be of equal validity but give different preference estimates regardless of the health context; thus, they may be measuring different constructs. Therefore, choice between methods is likely to be based on normative considerations related to coherence with theoretical frameworks and on pragmatic considerations related to ease of data collection.