Don't be late! Postponing cognitive decline and preventing early unemployment in people with multiple sclerosis: a study protocol.

BACKGROUND: Up to 65% of people with multiple sclerosis (PwMS) develop cognitive deficits, which hampers their ability to work, participating in day-to-day life and ultimately reducing quality of life (QoL). Early cognitive symptoms are often less tangible to PwMS and their direct environment and are noticed only when symptoms and work functioning problems become more advanced, i.e., when (brain) damage is already advanced. Treatment of symptoms at a late stage can lead to cognitive impairment and unemployment, highlighting the need for preventative interventions in PwMS. AIMS: This study aims to evaluate the (cost-) effectiveness of two innovative preventative interventions, aimed at postponing cognitive decline and work functioning problems, compared to enhanced usual care in improving health-related QoL (HRQoL). METHODS: Randomised controlled trial including 270 PwMS with mild cognitive impairment, who have paid employment ≥ 12 h per week and are able to participate in physical exercise (Expanded Disability Status Scale < 6.0). Participants are randomised across three study arms: 1) 'strengthening the brain' - a lifestyle intervention combining personal fitness, mental coaching, dietary advice, and cognitive training; 2) 'strengthening the mind' - a work-focused intervention combining the capability approach and the participatory approach in one-on-one coaching by trained work coaches who have MS themselves; 3) Control group-receiving general information about cognitive impairment in MS and receiving care as usual. Intervention duration is four months, with short-term and long-term follow-up measurements at 10 and 16 months, respectively. The primary outcome measure of the Don't be late! intervention study will be HRQoL as measured with the 36-item Short Form. Secondary outcomes include cognition, work related outcomes, physical functioning, structural and functional brain changes, psychological functioning, and societal costs. Semi-structured interviews and focus groups with stakeholders will be organised to qualitatively reflect on the process and outcome of the interventions. DISCUSSION: This study seeks to prevent (further) cognitive decline and job loss due to MS by introducing tailor-made interventions at an early stage of cognitive symptoms, thereby maintaining or improving HRQoL. Qualitative analyses will be performed to allow successful implementation into clinical practice. TRIAL REGISTRATION: Retrospectively registered at ClinicalTrials.gov with reference number NCT06068582 on 10 October 2023.

Costs of care trajectories of people with dementia compared with matched controls. Longitudinal analysis of linked health and administrative data.

OBJECTIVES: To provide insight into the health and social care costs during the disease trajectory in persons with dementia and the impact of institutionalization and death on healthcare costs compared with matched persons without dementia. METHODS: Electronic health record data from family physicians were linked with national administrative databases to estimate costs of primary care, medication, secondary care, mental care, home care and institutional care for people with dementia and matched persons from the year before the recorded dementia diagnosis until death or a maximum of 4 years after the diagnosis. RESULTS: Total mean health and social care costs among persons with dementia increased substantially during the disease trajectory, mainly due to institutional care costs. For people who remained living in the community, mean health and social care costs are higher for people with dementia than for those without dementia, while for those who are admitted to a long-term care facility, mean health and social care costs are higher for people without dementia than for those with dementia. CONCLUSIONS: The steep rise in health and social care costs across the dementia care trajectory is mainly due to increasing costs for institutional care. For those remaining in the community, home care costs and hospital care costs were the main cost drivers. Future research should adopt a societal perspective to investigate the influence of including social costs.

Cost-effectiveness of the FindMyApps eHealth intervention vs. digital care as usual: results from a randomised controlled trial.

OBJECTIVES: Despite growing interest, the cost-effectiveness of eHealth interventions for supporting quality of life of people with dementia and their caregivers remains unclear. This study evaluated the cost-effectiveness of the FindMyApps intervention, compared to digital care-as-usual. FindMyApps aims to help people with dementia and their caregivers find and learn to use tablet apps that may support social participation and self-management of people with dementia and sense of competence of caregivers. METHOD: A randomised controlled trial (Netherlands Trial Register NL8157) was conducted, including people with mild cognitive impairment (MCI) or mild dementia and their informal caregivers (FindMyApps n = 76, digital care-as-usual n = 74). Outcomes for people with MCI/dementia were Quality-Adjusted Life-Years (QALYs), calculated from EQ-5D-5L data and the Dutch tariff for utility scores, social participation (Maastricht Social Participation Profile) and quality of life (Adult Social Care Outcomes Toolkit), and for caregivers, QALYs and sense of competence (Short Sense of Competence Questionnaire). Societal costs were calculated using data collected with the RUD-lite instrument and the Dutch costing guideline. Multiple imputation was employed to fill in missing cost and effect data. Bootstrapped multilevel models were used to estimate incremental total societal costs and incremental effects between groups which were then used to calculate Incremental Cost-Effectiveness Ratios (ICERs). Cost-effectiveness acceptability curves were estimated. RESULTS: In the FindMyApps group, caregiver SSCQ scores were significantly higher compared to care-as-usual, n = 150, mean difference = 0.75, 95% CI [0.14, 1.38]. Other outcomes did not significantly differ between groups. Total societal costs for people with dementia were not significantly different, n = 150, mean difference = €-774, 95%CI [-2.643, .,079]. Total societal costs for caregivers were significantly lower in the FindMyApps group compared to care-as-usual, n = 150, mean difference = € -392, 95% CI [-1.254, -26], largely due to lower supportive care costs, mean difference = €-252, 95% CI [-1.009, 42]. For all outcomes, the probability that FindMyApps was cost-effective at a willingness-to-pay threshold of €0 per point of improvement was 0.72 for people with dementia and 0.93 for caregivers. CONCLUSION: FindMyApps is a cost-effective intervention for supporting caregivers' sense of competence. Further implementation of FindMyApps is warranted.

Dealing with confounding in observational studies: A scoping review of methods evaluated in simulation studies with single-point exposure.

The aim of this article was to perform a scoping review of methods available for dealing with confounding when analyzing the effect of health care treatments with single-point exposure in observational data. We aim to provide an overview of methods and their performance assessed by simulation studies indexed in PubMed. We searched PubMed for simulation studies published until January 2021. Our search was restricted to studies evaluating binary treatments and binary and/or continuous outcomes. Information was extracted on the methods' assumptions, performance, and technical properties. Of 28,548 identified references, 127 studies were eligible for inclusion. Of them, 84 assessed 14 different methods (ie, groups of estimators that share assumptions and implementation) for dealing with measured confounding, and 43 assessed 10 different methods for dealing with unmeasured confounding. Results suggest that there are large differences in performance between methods and that the performance of a specific method is highly dependent on the estimator. Furthermore, the methods' assumptions regarding the specific data features also substantially influence the methods' performance. Finally, the methods result in different estimands (ie, target of inference), which can even vary within methods. In conclusion, when choosing a method to adjust for measured or unmeasured confounding it is important to choose the most appropriate estimand, while considering the population of interest, data structure, and whether the plausibility of the methods' required assumptions hold.

Behavioural Activation versus Treatment as Usual for Depressed Older Adults in Primary Care: A Pragmatic Cluster-Randomised Controlled Trial.

INTRODUCTION: Effective non-pharmacological treatment options for depression in older adults are lacking. OBJECTIVE: The effectiveness of behavioural activation (BA) by mental health nurses (MHNs) for depressed older adults in primary care compared with treatment as usual (TAU) was evaluated. METHODS: In this multicentre cluster-randomised controlled trial, 59 primary care centres (PCCs) were randomised to BA and TAU. Consenting older (≥65 years) adults (n = 161) with clinically relevant symptoms of depression (PHQ-9 ≥ 10) participated. Interventions were an 8-week individual MHN-led BA programme and unrestricted TAU in which general practitioners followed national guidelines. The primary outcome was self-reported depression (QIDS-SR16) at 9 weeks and 3, 6, 9, and 12-month follow-up. RESULTS: Data of 96 participants from 21 PCCs in BA and 65 participants from 16 PCCs in TAU, recruited between July 4, 2016, and September 21, 2020, were included in the intention-to-treat analyses. At post-treatment, BA participants reported significantly lower severity of depressive symptoms than TAU participants (QIDS-SR16 difference = -2.77, 95% CI = -4.19 to -1.35), p < 0.001; between-group effect size = 0.90; 95% CI = 0.42-1.38). This difference persisted up to the 3-month follow-up (QIDS-SR16 difference = -1.53, 95% CI = -2.81 to -0.26, p = 0.02; between-group effect size = 0.50; 95% CI = 0.07-0.92) but not up to the 12-month follow-up [QIDS-SR16 difference = -0.89 (-2.49 to 0.71)], p = 0.28; between-group effect size = 0.29 (95% CI = -0.82 to 0.24). CONCLUSIONS: BA led to a greater symptom reduction of depressive symptoms in older adults, compared to TAU in primary care, at post-treatment and 3-month follow-up, but not at 6- to 12-month follow-up.

Mapping Oswestry Disability Index Responses to EQ-5D-3L Utility Values: Are Cost-Utility Results Valid?

OBJECTIVES: To develop and validate approaches for mapping Oswestry Disability Index responses to 3-level version of EQ-5D utility values and to evaluate the impact of using mapped utility values on cost-utility results compared with published regression models. METHODS: Three response mapping approaches were developed in a random sample of 70% of 18 692 patients with low back pain: nonparametric approach (Non-p), nonparametric approach excluding logical inconsistencies (Non-peLI), and ordinal logistic regression (OLR). Performance was assessed in the remaining 30% using R-square (R2), root mean square error (RMSE), and mean absolute error (MAE). To evaluate whether MAEs and their 95% limits of agreement (LA) were clinically relevant, a minimally clinically important difference of 0.074 was used. Probabilities of cost-effectiveness estimated using observed and mapped utility values were compared in 2 economic evaluations. RESULTS: The Non-p performed the best (R2 = 0.43; RMSE = 0.22; MAE = 0.03; 95% LA = -0.40 to 0.47) compared with the Non-peLI (R2 = 0.07; RMSE = 0.29; MAE = -0.15; 95% LA = -0.63 to 0.34) and OLR (R2 = 0.22; RMSE = 0.26; MAE = 0.02; 95% LA = -0.49 to 0.53). MAEs were lower than the minimally clinically important difference for the Non-p and OLR but not for the Non-peLI. Differences in probabilities of cost-effectiveness ranged from 1% to 4% (Non-p), 0.1% to 9% (Non-peLI), and 0.1% to 20% (OLR). CONCLUSIONS: Results suggest that the developed response mapping approaches are not valid for estimating individual patients' 3-level version of EQ-5D utility values, and-depending on the approach-may considerably affect cost-utility results. The developed approaches did not perform better than previously published regression-based models and are therefore not recommended for use in economic evaluations.

The cost effectiveness of personalized dietary advice to increase protein intake in older adults with lower habitual protein intake: a randomized controlled trial.

PURPOSE: To examine the cost effectiveness of dietary advice to increase protein intake on 6-month change in physical functioning among older adults. METHODS: In this multicenter randomized controlled trial, 276 community-dwelling older adults with a habitual protein intake < 1.0 g/kg adjusted body weight (aBW)/d were randomly assigned to either Intervention 1; advice to increase protein intake to ≥ 1.2 g/kg aBW/d (PROT, n = 96), Intervention 2; similar advice and in addition advice to consume protein (en)rich(ed) foods within half an hour after usual physical activity (PROT + TIMING, n = 89), or continue the habitual diet with no advice (CON, n = 91). Primary outcome was 6-month change in 400-m walk time. Secondary outcomes were 6-month change in physical performance, leg extension strength, grip strength, body composition, self-reported mobility limitations and quality of life. We evaluated cost effectiveness from a societal perspective. RESULTS: Compared to CON, a positive effect on walk time was observed for PROT; - 12.4 s (95%CI, - 21.8 to - 2.9), and for PROT + TIMING; - 4.9 s (95%CI, - 14.5 to 4.7). Leg extension strength significantly increased in PROT (+ 32.6 N (95%CI, 10.6-54.5)) and PROT + TIMING (+ 24.3 N (95%CI, 0.2-48.5)) compared to CON. No significant intervention effects were observed for the other secondary outcomes. From a societal perspective, PROT was cost effective compared to CON. CONCLUSION: Dietary advice to increase protein intake to ≥ 1.2 g/kg aBW/d improved 400-m walk time and leg strength among older adults with a lower habitual protein intake. From a societal perspective, PROT was considered cost-effective compared to CON. These findings support the need for re-evaluating the protein RDA of 0.8 g/kg BW/d for older adults. TRIAL REGISTRATION: The trial has been registered at ClinicalTrials.gov (NCT03712306). Date of registration: October 2018. Registry name: The (Cost) Effectiveness of Increasing Protein Intake on Physical Functioning in Older Adults. Trial Identifier: NCT03712306.

A scoping review of statistical methods for trial-based economic evaluations: The current state of play.

The statistical quality of trial-based economic evaluations is often suboptimal, while a comprehensive overview of available statistical methods is lacking. Therefore, this review summarized and critically appraised available statistical methods for trial-based economic evaluations. A literature search was performed to identify studies on statistical methods for dealing with baseline imbalances, skewed costs and/or effects, correlated costs and effects, clustered data, longitudinal data, missing data and censoring in trial-based economic evaluations. Data was extracted on the statistical methods described, their advantages, disadvantages, relative performance and recommendations of the study. Sixty-eight studies were included. Of them, 27 (40%) assessed methods for baseline imbalances, 39 (57%) assessed methods for skewed costs and/or effects, 27 (40%) assessed methods for correlated costs and effects, 18 (26%) assessed methods for clustered data, 7 (10%) assessed methods for longitudinal data, 26 (38%) assessed methods for missing data and 10 (15%) assessed methods for censoring. All identified methods were narratively described. This review provides a comprehensive overview of available statistical methods for dealing with the most common statistical complexities in trial-based economic evaluations. Herewith, it can provide valuable input for researchers when deciding which statistical methods to use in a trial-based economic evaluation.

Can EQ-5D-3L utility values of low back pain patients be validly predicted by the Oswestry Disability Index for use in cost-effectiveness analyses?

PURPOSE: To assess whether regression modeling can be used to predict EQ-5D-3L utility values from the Oswestry Disability Index (ODI) in low back pain (LBP) patients for use in cost-effectiveness analysis. METHODS: EQ-5D-3L utility values of LBP patients were estimated using their ODI scores as independent variables using regression analyses, while adjusting for case-mix variables. Six different models were estimated: (1) Ordinary Least Squares (OLS) regression, with total ODI score, (2) OLS, with ODI item scores as continuous variables, (3) OLS, with ODI item scores as ordinal variables, (4) Tobit model, with total ODI score, (5) Tobit model, with ODI item scores as continuous variables, and (6) Tobit model, with ODI item scores as ordinal variables. The models' performance was assessed using explained variance (R2) and root mean squared error (RMSE). The potential impact of using predicted instead of observed EQ-5D-3L utility values on cost-effectiveness outcomes was evaluated in two empirical cost-effectiveness analysis. RESULTS: Complete individual patient data of 18,692 low back pain patients were analyzed. All models had a more or less similar R2 (range 45-52%) and RMSE (range 0.21-0.22). The two best performing models produced similar probabilities of cost-effectiveness for a range of willingness-to-pay (WTP) values compared to those based on the observed EQ-5D-3L values. For example, the difference in probabilities ranged from 2 to 5% at a WTP of 50,000 €/QALY gained. CONCLUSION: Results suggest that the ODI can be validly used to predict low back pain patients' EQ-5D-3L utility values and QALYs for use in cost-effectiveness analyses.

Endometrial ablation plus levonorgestrel releasing intrauterine system versus endometrial ablation alone in women with heavy menstrual bleeding: study protocol of a multicentre randomised controlled trial; MIRA2 trial.

BACKGROUND: It is estimated that between 12 to 25% of women who undergo an endometrial ablation for heavy menstrual bleeding (HMB) are dissatisfied after two years because of recurrent menstrual bleeding and/or cyclical pelvic pain, with around 15% of these women ultimately having a hysterectomy. The insertion of a levonorgestrel-releasing intrauterine system (LNG-IUS) immediately after endometrial ablation may inactivate residual untreated endometrium and/or inhibit the regeneration of endometrial tissue. Furthermore, the LNG-IUS may prevent agglutination of the uterine walls preventing intrauterine adhesion formation associated with endometrial ablation. In these ways, insertion of an LNG-IUS immediately after endometrial ablation might prevent subsequent hysterectomies because of persisting uterine bleeding and cyclical pelvic pain or pain that arises de novo. Hence, we evaluate if the combination of endometrial ablation and an LNG-IUS is superior to endometrial ablation alone in terms of reducing subsequent rates of hysterectomy at two years following the initial ablative procedure. METHODS/DESIGN: We perform a multicentre randomised controlled trial in 35 hospitals in the Netherlands. Women with heavy menstrual bleeding, who opt for treatment with endometrial ablation and without contraindication for an LNG-IUS are eligible. After informed consent, participants are randomly allocated to either endometrial ablation plus LNG-IUS or endometrial ablation alone. The primary outcome is the hysterectomy rate at 24 months following endometrial ablation. Secondary outcomes include women's satisfaction, reinterventions, complications, side effects, menstrual bleeding patterns, quality of life, societal costs. DISCUSSION: The results of this study will help clinicians inform women with HMB who opt for treatment with endometrial ablation about whether concomitant use of the LNG-IUS is beneficial for reducing the need for hysterectomy due to ongoing bleeding and/or pain symptoms. Trial registration Dutch Trial registration: NL7817. Registered 20 June 2019, https://www.trialregister.nl/trial/7817 .

Physical activity as a risk or protective factor for falls and fall-related fractures in non-frail and frail older adults: a longitudinal study.

BACKGROUND: Physical activity may be both a risk and protective factor for falls and fall-related fractures. Despite its positive effects on muscle and bone health, physical activity also increases exposure to situations where falls and fractures occur. This paradox could possibly be explained by frailty status. Therefore, the aim of this study was to investigate the associations between physical activity and both falls and fractures, and to determine whether frailty modifies the association of physical activity with falls, and fractures. METHODS: Data of 311 community-dwelling participants aged 75 years or older from the Longitudinal Aging Study Amsterdam, who participated in a three-year longitudinal study with five nine-monthly measurements between 2015/2016 and 2018/2019. Their mean age was 81.1 (SD 4.8) years and frailty was present in 30.9% of the participants. Physical activity in minutes per day was objectively assessed with an inertial sensor (Actigraph) for seven consecutive days. Falls and fractures were assessed every nine months using self-report during an interview over a follow-up period of three years. Frailty was determined at baseline using the frailty index. Associations were estimated using longitudinal logistic regression analyses based on generalized estimating equations. RESULTS: No association between physical activity and falls was found (OR = 1.00, 95% CI: 0.99-1.00). Fall risk was higher in frail compared to non-frail adults (OR = 2.21, 95% CI: 1.33-3.68), but no effect modification was seen of frailty on the association between physical activity and falls. Also no relation between physical activity and fractures was found (OR = 1.00, 95% CI: 0.99-1.01). Fracture risk was higher in frail compared to non-frail adults (OR = 2.81, 95% CI: 1.02-7.75), but also no effect modification of frailty was present in the association between physical activity and fractures. CONCLUSIONS: No association between physical activity and neither falls nor fractures was found, and frailty appeared not to be an effect modifier. However, frailty was a risk factor for falls and fractures in this population of older adults. Our findings suggest that physical activity can be safely recommended in non-frail and frail populations for general health benefits, without increasing the risk of falls.

Cost-effectiveness of Guided Internet-Delivered Cognitive Behavioral Therapy in Comparison with Care-as-Usual for Patients with Insomnia in General Practice.

STUDY OBJECTIVES: Clinical guidelines recommend cognitive-behavioral therapy for insomnia (CBT-I) as first-line treatment. However, provision of CBT-I is limited due to insufficient time and expertise. Internet-delivered CBT-I might bridge this gap. This study aimed to estimate the cost-effectiveness of guided, internet-delivered CBT-I (i-Sleep) compared to care-as-usual for insomnia patients in general practice over 26 weeks from a societal perspective. METHODS: Primary outcomes were the Insomnia Severity Index (ISI, continuous score and clinically relevant response), and Quality-Adjusted Life Years (QALYs). Societal costs were assessed at baseline, and at 8 and 26 weeks. Missing data were imputed using multiple imputation. Statistical uncertainty around cost and effect differences was estimated using bootstrapping, and presented in cost-effectiveness planes and acceptability curves. RESULTS: The difference in societal costs between i-Sleep and care-as-usual was not statistically significant (-€318; 95% CI -1282 to 645). Cost-effectiveness analyses revealed a 95% probability of i-Sleep being cost-effective compared to care-as-usual at ceiling ratios of €450/extra point of improvement in ISI score and €7,000/additional response to treatment, respectively. Cost-utility analysis showed a 67% probability of cost-effectiveness for i-Sleep compared to care-as-usual at a ceiling ratio of 20,000 €/QALY gained. CONCLUSIONS: The internet-delivered intervention may be considered cost-effective for insomnia severity in comparison with care-as-usual from the societal perspective. However, the improvement in insomnia severity symptoms did not result in similar improvements in QALYs.

Assessing the Impact of EQ-5D Country-specific Value Sets on Cost-utility Outcomes.

PURPOSE: To assess the impact of EQ-5D country-specific value sets on cost-utility outcomes. METHODS: Data from 2 randomized controlled trials on low back pain (LBP) and depression were used. 3L value sets were identified from the EuroQol Web site. A nonparametric crosswalk was employed for each tariff to obtain the likely 5L values. Differences in quality-adjusted life years (QALYs) between countries were tested using paired t tests, with United Kingdom as reference. Cost-utility outcomes were estimated for both studies and both EQ-5D versions, including differences in QALYs and cost-effectiveness acceptability curves. RESULTS: For the 3L, QALYs ranged between 0.650 (Taiwan) and 0.892 (United States) in the LBP study and between 0.619 (Taiwan) and 0.879 (United States) in the depression study. In both studies, most country-specific QALY estimates differed statistically significantly from that of the United Kingdom. Incremental cost-effectiveness ratios ranged between &OV0556;2044/QALY (Taiwan) and &OV0556;5897/QALY (Zimbabwe) in the LBP study and between &OV0556;38,287/QALY (Singapore) and &OV0556;96,550/QALY (Japan) in the depression study. At the NICE threshold of &OV0556;23,300/QALY (≈£20,000/QALY), the intervention's probability of being cost-effective versus control ranged between 0.751 (Zimbabwe) and 0.952 (Taiwan) and between 0.230 (Canada) and 0.396 (Singapore) in the LBP study and depression study, respectively. Similar results were found for the 5L, with extensive differences in ICERs and moderate differences in the probability of cost-effectiveness. CONCLUSIONS: This study indicates that the use of different EQ-5D country-specific value sets impacts on cost-utility outcomes. Therefore, to account for the fact that health state preferences are affected by sociocultural differences, relevant country-specific value sets should be used.

Cost-Effectiveness of perioperative Vaginally Administered estrogen in postmenopausal women undergoing prolapse surgery (EVA trial): study protocol for a multicenter double-blind randomized placebo-controlled trial.

BACKGROUND: Surgery for pelvic organ prolapse (POP) is associated with high recurrence rates. The costs associated with the treatment of recurrent POP are huge, and the burden from women who encounter recurrent POP, negatively impacts their quality of life. Estrogen therapy might improve surgical outcome for POP due to its potential beneficial effects. It is thought that vaginal estrogen therapy improves healing and long-term maintenance of connective tissue integrity. Hence, this study aims to evaluate the cost-effectiveness of perioperative vaginal estrogen therapy in postmenopausal women undergoing POP surgery. METHODS: The EVA trial is a multi-center double-blind randomized placebo-controlled trial conducted in the Netherlands comparing the effectiveness and costs-effectiveness of vaginal estrogen therapy. This will be studied in 300 postmenopausal women undergoing primary POP surgery, with a POP-Q stage of ≥ 2. After randomization, participants administer vaginal estrogen cream or placebo cream from 4 to 6 weeks preoperative until 12 months postoperative. The primary outcome is subjective improvement of POP symptoms at 1 year follow-up, measured with the Patient Global Impression of Improvement (PGI-I) scale. Secondary outcomes are POP-Q anatomy in all compartments, re-interventions, surgery related complications, general and disease specific quality of life, sexual function, signs and complaints of vaginal atrophy, vaginal pH, adverse events, costs, and adherence to treatment. Follow up is scheduled at 6 weeks, 6 months and 12 months postoperative. Data will be collected using validated questionnaires and out-patient visits including gynecological examination performed by an independent gynecologist. DISCUSSION: This study investigates whether perioperative vaginal estrogen will be cost-effective in the surgical treatment of POP in postmenopausal women. It is hypothesized that estrogen therapy will show a reduction in recurrent POP symptoms and a reduction in reoperations for POP, with subsequent improved quality of life among women and cost savings. Trial registrationNetherlands Trial Registry: NL6853; registered 19-02-2018, https://www.trialregister.nl/trial/6853 . EudraCT: 2017-003144-21; registered: 24-07-2017.

The (cost-)effectiveness of an implemented fall prevention intervention on falls and fall-related injuries among community-dwelling older adults with an increased risk of falls: protocol for the in balance randomized controlled trial.

BACKGROUND: Falls and fall-related injuries among older adults are a serious threat to the quality of life and result in high healthcare and societal costs. Despite evidence that falls can be prevented by fall prevention programmes, practical barriers may challenge the implementation of these programmes. In this study, we will investigate the effectiveness and cost-effectiveness of In Balance, a fourteen-week, low-cost group fall prevention intervention, that is widely implemented in community-dwelling older adults with an increased fall risk in the Netherlands. Moreover, we will be the first to include cost-effectiveness for this intervention. Based on previous evidence of the In Balance intervention in pre-frail older adults, we expect this intervention to be (cost-)effective after implementation-related adjustments on the target population and duration of the intervention. METHODS: This study is a single-blinded, multicenter randomized controlled trial. The target sample will consist of 256 community-dwelling non-frail and pre-frail adults of 65 years or older with an increased risk of falls. The intervention group receives the In Balance intervention as it is currently widely implemented in Dutch healthcare, which includes an educational component and physical exercises. The physical exercises are based on Tai Chi principles and focus on balance and strength. The control group receives general written physical activity recommendations. Primary outcomes are the number of falls and fall-related injuries over 12 months follow-up. Secondary outcomes consist of physical performance measures, physical activity, confidence, health status, quality of life, process evaluation and societal costs. Mixed model analyses will be conducted for both primary and secondary outcomes and will be stratified for non-frail and pre-frail adults. DISCUSSION: This trial will provide insight into the clinical and societal impact of an implemented Dutch fall prevention intervention and will have major benefits for older adults, society and health insurance companies. In addition, results of this study will inform healthcare professionals and policy makers about timely and (cost-)effective prevention of falls in older adults. TRIAL REGISTRATION: Netherlands Trial Register: NL9248 (registered February 13, 2021).

Evaluation of FindMyApps: protocol for a randomized controlled trial of the effectiveness and cost-effectiveness of a tablet-based intervention to improve self-management and social participation of community-dwelling people with mild dementia, compared to usual tablet use.

BACKGROUND: For the rising number of people living with dementia, cost-effective community-based interventions to support psychosocial care are needed. The FindMyApps intervention has been developed with and for people with dementia and their caregivers, to help them use tablets to facilitate self-management and engagement in meaningful social activities. A feasibility study and exploratory pilot trial evaluating FindMyApps have been carried out. This definitive trial further evaluates the effectiveness of the intervention and, for the first time, the cost-effectiveness. METHODS: A randomized controlled non-blinded single-center two-arm superiority trial will be conducted. Community-dwelling people with Mild Cognitive Impairment (MCI), or dementia with a Mini Mental-State Examination (MMSE) of > 17 and < 26, or Global Deterioration Scale 3 or 4, with an informal caregiver and access to a wireless internet connection will be included. In total, 150 patient-caregiver dyads will be randomly allocated to receive either usual care (control arm - tablet computer; n = 75 dyads) or usual care and the FindMyApps intervention (experimental arm - tablet computer and FindMyApps; n = 75 dyads). The primary outcomes are: for people with dementia, self-management and social participation; for caregivers, sense of competence. In addition to a main effect analysis, a cost-effectiveness analysis will be performed. In line with MRC guidance for evaluation of complex interventions a process evaluation will also be undertaken. DISCUSSION: Results of the trial are expected to be available in 2023 and will be submitted for publication in international peer-reviewed scientific journals, in addition to conference presentations and reporting via the EU Marie Sklodowska-Curie DISTINCT ITN network. By providing evidence for or against the effectiveness and cost-effectiveness of the FindMyApps intervention, the results of the trial will influence national implementation of FindMyApps. We hope that the results of the trial will further stimulate research and development at the intersection of technology and psycho-social care in dementia. We hope to further demonstrate that the randomized controlled trial is a valuable and feasible means of evaluating new digital technologies, to stimulate further high-quality research in this growing field. TRIAL REGISTRATION NUMBER: Netherlands Trial Register: NL8157 ; registered 15th November 2019.

The statistical approach in trial-based economic evaluations matters: get your statistics together!

BACKGROUND: Baseline imbalances, skewed costs, the correlation between costs and effects, and missing data are statistical challenges that are often not adequately accounted for in the analysis of cost-effectiveness data. This study aims to illustrate the impact of accounting for these statistical challenges in trial-based economic evaluations. METHODS: Data from two trial-based economic evaluations, the REALISE and HypoAware studies, were used. In total, 14 full cost-effectiveness analyses were performed per study, in which the four statistical challenges in trial-based economic evaluations were taken into account step-by-step. Statistical approaches were compared in terms of the resulting cost and effect differences, ICERs, and probabilities of cost-effectiveness. RESULTS: In the REALISE study and HypoAware study, the ICER ranged from 636,744€/QALY and 90,989€/QALY when ignoring all statistical challenges to - 7502€/QALY and 46,592€/QALY when accounting for all statistical challenges, respectively. The probabilities of the intervention being cost-effective at 0€/ QALY gained were 0.67 and 0.59 when ignoring all statistical challenges, and 0.54 and 0.27 when all of the statistical challenges were taken into account for the REALISE study and HypoAware study, respectively. CONCLUSIONS: Not accounting for baseline imbalances, skewed costs, correlated costs and effects, and missing data in trial-based economic evaluations may notably impact results. Therefore, when conducting trial-based economic evaluations, it is important to align the statistical approach with the identified statistical challenges in cost-effectiveness data. To facilitate researchers in handling statistical challenges in trial-based economic evaluations, software code is provided.

[Five years University Practice of Elderly Care: users, care provided, costs and experiences]. / Vijf jaar Universitaire Praktijk Ouderengeneeskunde: gebruikers, geleverde zorg, kosten en ervaringen.

The increasing number of elderly people living at home demands a strengthening of primary care for (vulnerable) older adults. Therefore, in 2015 the VU University Medical Centre in Amsterdam founded the Universitaire Praktijk Ouderengeneeskunde (UPO) (University Practice for Elderly Care). This practice makes the expertise of the Elderly Care physician (SO) available in primary care through a close and easy accessible collaboration between the SO and the General Practitioner. The aim of this research is an evaluation of the UPO, in order to determine the added value of this care innovation and to identify areas for improvement. This research consists of a quantitative part in which the characteristics of the 190 treated UPO patients have been assessed. Also, costs have been estimated of UPO care compared to expected usual care. The qualitative part of this study consists of 22 interviews with the most important UPO stakeholders. The results of this study show  that 1) the UPO seems to meet a demand from general practitioners to support them in the care of vulnerable elderly people with mostly cognitive disorders, 2) this care seems to save costs and 3) the UPO was appreciated by most of those involved. The current results call for applying this care innovation in other regions and to evaluate it on a larger scale.

[Assessing quality of life in older adults living at home: Overview and justification of fourteen relevant domains]. / Evalueren van kwaliteit van leven bij thuiswonende ouderen.

An increasing group of older adults living at home in the Netherlands requires proper support through the use of services. Determining important outcomes is crucial in this respect. For this specific group, broad outcomes in terms of quality of life (QoL) are relevant, focusing on the influence of services on capabilities. This article describes the development and content of the ASCOT-NL (Adult Social Care Outcomes Toolkit, Dutch version) and the EQLT (Extended Quality of Life Tool), and highlights application possibilities in the evaluation of care. Both instruments aim to measure effects of care on QoL of elderly people living at home in multiple relevant domains. The ASCOT-NL has eight domains, the EQLT includes these eight domains and adds six domains, resulting in a total of fourteen domains. The domains of the ASCOT-NL are based on the goals of social support and care; the additional domains of the EQLT are based on empirical research on QoL from the perspective of older people living at home and how care can contribute to QoL.

The effects of once- versus twice-weekly sessions on psychotherapy outcomes in depressed patients.

BACKGROUND: It is unclear what session frequency is most effective in cognitive-behavioural therapy (CBT) and interpersonal psychotherapy (IPT) for depression. AIMS: Compare the effects of once weekly and twice weekly sessions of CBT and IPT for depression. METHOD: We conducted a multicentre randomised trial from November 2014 through December 2017. We recruited 200 adults with depression across nine specialised mental health centres in the Netherlands. This study used a 2 × 2 factorial design, randomising patients to once or twice weekly sessions of CBT or IPT over 16-24 weeks, up to a maximum of 20 sessions. Main outcome measures were depression severity, measured with the Beck Depression Inventory-II at baseline, before session 1, and 2 weeks, 1, 2, 3, 4, 5 and 6 months after start of the intervention. Intention-to-treat analyses were conducted. RESULTS: Compared with patients who received weekly sessions, patients who received twice weekly sessions showed a statistically significant decrease in depressive symptoms (estimated mean difference between weekly and twice weekly sessions at month 6: 3.85 points, difference in effect size d = 0.55), lower attrition rates (n = 16 compared with n = 32) and an increased rate of response (hazard ratio 1.48, 95% CI 1.00-2.18). CONCLUSIONS: In clinical practice settings, delivery of twice weekly sessions of CBT and IPT for depression is a way to improve depression treatment outcomes.