Budget impact analysis of a Lifestyle-integrated Functional Exercise (LiFE) program for older people in Germany: a Markov model based on data from the LiFE-is-LiFE trial.

BACKGROUND: Fall prevention is important for healthy ageing, but the economic impact of fall prevention are scarcely investigated. A recent cost-effectiveness analysis compared a group-delivered Lifestyle-integrated Functional Exercise Program (gLiFE) with an individually-delivered program (LiFE) in community-dwelling people (aged ≥ 70 years) at risk of falling. In addition, the current study aimed to analyze the budget impact of LiFE and gLiFE, compared with standard care in Germany. METHODS: A Markov model was developed to reflect falls and associated care needs for community-dwelling persons over 5 years. The intervention effects of LiFE and gLiFE were shown to be equivalent in a non-inferiority trial, although the costs differed. Outpatient, inpatient, and intervention costs were assessed from a payer's perspective. The effect of parameter uncertainty was assessed in sensitivity analyses. RESULTS: The budget impact due to intervention costs was €510 million for LiFE and €186 million for gLiFE. Over five years, health care expenditures were €35,008 million for those receiving standard care, €35,416 million for those receiving LiFE, and €35,091 million for persons receiving gLiFE. Thereby, LiFE and gLiFE could prevent 2700 deaths and 648,000 falls over 5 years. Parameter uncertainties in the risk of falling, uptake of an intervention offer, and in the intervention effects had a major influence; thus cost savings for LiFE and gLiFE compared with standard care could be achieved for individuals with a high risk of falling. CONCLUSIONS: The results revealed that cost savings for LiFE and gLiFE compared with standard care could only be achieved for individuals at high risk of falling, with gLiFE being superior to LiFE. Future research should consider benefits and aspects of fall prevention beyond falls (e.g., physical activity, social aspects, and personal preferences of participants). TRIAL REGISTRATION: The study was preregistered under underclinicaltrials.gov (identifier: NCT03462654) on 12th March 2018; https://clinicaltrials.gov/ct2/show/NCT03462654 .

Estimation of Average and Maximum Daily-Life Mobility Performance Using the Timed Up-and-Go: Exploring the Added Value of an Instrumented Timed Up-and-Go.

INTRODUCTION: The association between specific motor capacity variables obtained in a laboratory and parameters of daily-life mobility performance (MP) obtained via wearables is still unclear. The Timed Up-and-Go (TUG) test is a widely used motor capacity tests available either as traditional hand-stopped TUG or as instrumented TUG (iTUG), providing specific information about its subphases. This study aimed to: (1) estimate the association between the TUG and specific parameters reflecting average and maximum daily-life MP, (2) estimate the benefits of the iTUG in terms of explaining MP in daily life compared to the TUG. METHODS: The present study was a cross-sectional analysis using baseline data of 294 older persons (mean age: 76.7 ± 5.3 years). Univariate linear regression analysis was performed to delineate the coefficient of determination between TUG time and participants' MP. MP variables containing mean cadence (MCA) to represent average performance and the 95th percentile of mean cadence of walks with more than three steps (p95>3stepsMCA) to represent maximum performance. To determine whether the iTUG variables give more information about MP, a stepwise multivariate regression analysis between iTUG variables and the p95>3stepsMCA variable to represent maximum performance was conducted. RESULTS: The univariate regression models revealed associations of the TUG with MCA (adjusted R2 = 0.078, p < 0.001) and p95>3stepsMCA (adjusted R2 = 0.199, p < 0.001). The multivariate stepwise regression models revealed a total explanation of maximum daily-life MP (p95>3stepsMCA) of the TUG (adjusted R2 = 0.199, p < 0.001) versus iTUG (adjusted R2 = 0.278, p < 0.010). DISCUSSION/CONCLUSION: This study shows that the TUG better reflects maximum daily-life MP than average daily-life MP. Moreover, we demonstrate the added value of the iTUG for a more accurate estimation of daily MP compared to the traditional TUG. The iTUG is recommended to estimate maximum daily-life MP in fall-prone older adults. The study is a step toward a specific assessment paradigm using capacity variables from the iTUG to estimate maximum daily-life MP.

Comparison of falls and cost-effectiveness of the group versus individually delivered Lifestyle-integrated Functional Exercise (LiFE) program: final results from the LiFE-is-LiFE non-inferiority trial.

BACKGROUND: the individually delivered Lifestyle-integrated Functional Exercise (LiFE) was shown to improve physical activity (PA) and reduce fall incidence, however being rather resource-consuming due to one-to-one delivery. A potentially less resource-intensive group format (gLiFE) was developed and compared against the original program, considering higher risk of falling due to possible PA enhancement. OBJECTIVE: to investigate non-inferiority in terms of PA-adjusted fall risk and cost-effectiveness of gLiFE at 12-month follow-up. DESIGN: single-blinded, randomised, multi-centre non-inferiority trial. SETTING: community. SUBJECTS: in total, 309 adults aged 70+ years at risk of or with history of falling; n = 153 in gLiFE, n = 156 in LiFE. METHODS: LiFE was delivered one-to-one at the participants' homes, gLiFE in a group. PA-adjusted fall risk was analysed using negative binomial regression to compare incidence rate ratios (IRR). Cost-effectiveness was presented by incremental cost-effectiveness ratios and cost-effectiveness acceptability curves, considering quality-adjusted life years, PA and falls as effect measures. Secondary analyses included PA (steps/day) and fall outcomes. RESULTS: non-inferiority was inconclusive (IRR 0.96; 95% confidence interval, CI 0.67; 1.37); intervention costs were lower for gLiFE, but cost-effectiveness was uncertain. gLiFE participants significantly increased PA (+1,090 steps/day; 95% CI 345 and 1.835) versus insignificant increase in LiFE (+569, 95% CI -31; 1,168). Number of falls and fallers were reduced in both formats. CONCLUSION: non-inferiority of gLiFE compared with LiFE was inconclusive after 12 months. Increases in PA were clinically relevant in both groups, although nearly twice as high in gLiFE. Despite lower intervention costs of gLiFE, it was not clearly superior in terms of cost-effectiveness.

Willingness to pay for a group and an individual version of the Lifestyle-integrated Functional Exercise program from a participant perspective.

BACKGROUND: Perceived benefits of intervention programs from a participant perspective can be examined by assessing their willingness to pay (WTP). Aiming to support decision-makers in their decision to implement a fall prevention program, this study examined (1) the WTP for a group-based and an individually delivered fall prevention program, (2) which factors influence WTP, and (3) whether the WTP exceeds the intervention costs. METHODS: WTP was elicited using Payment Cards from 237 individuals who participated in a randomized non-inferiority trial (LiFE-is-LiFE) comparing a group version of the Lifestyle-integrated Functional Exercise program (gLiFE) with the individually delivered version (LiFE). Linear regression models were used to examine factors associated with WTP. The net benefit for (g)LiFE was calculated as the difference between WTP and intervention costs, assuming different scenarios of intervention costs (varying group sizes of gLiFE) and hypothetical subsidy levels by a payer (€0, €50, or €75). RESULTS: The mean WTP was €196 (95% CI [172, 221]) for gLiFE and €228 (95% CI [204, 251]) for LiFE. In the linear regression model, WTP was significantly associated with delivery format (-€32, 95% CI [- 65, - 0.2], for gLiFE) and net household income (+ 68€, 95% CI [23, 113], for ≥€3000 compared to <€2000). The net benefit for gLiFE was positive in most cases. Due to higher intervention costs of LiFE compared to gLiFE (€298 vs. €113), the net benefit for LiFE was negative for the majority of the sample, even at a subsidy of €75. CONCLUSION: The results provide insight into how valuable the interventions are perceived by the participants and thereby may be used by decision-makers as complement to cost-effectiveness analyses. WTP for both programs was generally high, probably indicating that participants perceived the intervention as quite valuable. However, further research is needed on the WTP and net benefit of fall prevention programs, as results relied on the specific context of the LiFE-is-LiFE trial.

Cost-Effectiveness of a Group vs Individually Delivered Exercise Program in Community-Dwelling Persons Aged ≥70 Years.

OBJECTIVES: Interventions aimed at reducing falls and physical inactivity could alleviate the economic burden attributable to these factors. The study aimed to analyze the cost-effectiveness of a group-delivered version of the Lifestyle-integrated Functional Exercise Program compared with an individually delivered program version. DESIGN: An economic evaluation conducted alongside the LiFE-is-LiFE randomized non-inferiority trial. INTERVENTIONS: Group and individually delivered version of a program consisting of strength and balance exercises integrated into everyday activities to prevent falls. SETTING AND PARTICIPANTS: 309 community-dwelling older adults (aged ≥70 years) at risk of falling recruited around Heidelberg and Stuttgart (Germany). METHODS: Cost-effectiveness of the group program was assessed over 6 months using different effect measures [quality-adjusted life years (QALYs, EQ-5D-5L), physical activity (mean number of steps/day), and falls] and cost perspectives (societal and payer's). Incremental cost-effectiveness ratios were determined, and cost-effectiveness acceptability curves were constructed. RESULTS: From a societal perspective, mean costs, the number of falls, and the number of steps/day were somewhat higher in the group program, whereas QALYs were almost identical between the 2 interventions. From the payer's perspective, the incremental cost-effectiveness ratio for the group compared to the individual program were €56,733 per QALY and €4755 per fall prevented. Based on the cost-effectiveness acceptability curves, the cost-effectiveness of the group program had to be rated as uncertain for both effect measures and perspectives. In contrast, it demonstrated cost-effectiveness for increasing physical activity at willingness-to-pay values per additional 1000 steps/day of €1600 (societal perspective) or €600 (payer's perspective). CONCLUSIONS AND IMPLICATIONS: Compared to the individual program, the group program might be cost-effective for increasing physical activity in older adults but was unlikely to be cost-effective with regard to QALY or for preventing falls. The cost-effectiveness should be evaluated long-term and compared to a regular care group.

Sensitivity to Change and Responsiveness of the Original and the Shortened Version of the Community Balance and Mobility Scale for Young Seniors.

OBJECTIVE: To examine sensitivity to change and responsiveness of the Community Balance and Mobility Scale (CBM) and shortened CBM (s-CBM). DESIGN: Secondary analysis using data of a randomized controlled trial. SETTING: General community. PARTICIPANTS: Young community-dwelling seniors aged 61-70 years (N=134; mean age, 66.2±2.5y). INTERVENTIONS: Participants underwent 12 months of exercise intervention. MAIN OUTCOME MEASURES: CBM and s-CBM. Sensitivity to change was assessed using standardized response mean (SRM) and paired t tests as appropriate. Responsiveness was assessed using 2 minimal important difference (MID) estimates. Analyses were conducted for the full sample and for the subgroups "high-balance" and "low-balance," divided by median split. RESULTS: Inferential statistics revealed a significant CBM (P<.001) and s-CBM (P<.001) improvement within the full sample and the subgroups (high-balance: P=.001, P=.019; low-balance: P<.001, P<.001). CBM and s-CBM were moderately sensitive to change (SRM, 0.48 vs 0.38) within the full sample. In the high-balance subgroup, moderate SRM values (0.70) were found for the CBM and small values for the s-CBM (0.29). In the low-balance subgroup, moderate SRM values were found for the CBM (0.67) and high values for the s-CBM (0.80). For the full sample, CBM and s-CBM exceeded the lower but not the higher MID value. In the high-balance subgroup, the CBM exceeded both MID values, but the s-CBM exceeded only the lower. In the low-balance subgroup, CBM and s-CBM exceeded both MID values. CONCLUSIONS: The CBM is a suitable tool to detect intervention-related changes of balance and mobility in young, high-performing seniors. Both versions of the CBM scale show good sensitivity to change and responsiveness, particularly in young seniors with low balance.

Comparison of a group-delivered and individually delivered lifestyle-integrated functional exercise (LiFE) program in older persons: a randomized noninferiority trial.

BACKGROUND: The Lifestyle-Integrated Functional Exercise (LiFE) program is effective in improving strength, balance, and physical activity (PA) while simultaneously reducing falls in older people by incorporating exercise activities in recurring daily tasks. However, implementing the original LiFE program includes substantial resource requirements. Therefore, as part of the LiFE-is-LiFE project, a group format (gLiFE) of the LiFE program has been developed, which will be tested regarding its noninferiority to the individually delivered LiFE in terms of PA-adjusted fall incidence and overall cost-effectiveness. METHODS: In a multi-centre, single-blinded noninferiority trial, an envisaged sample of N = 300 participants (> 70 years; faller and/or confirmed falls risk; community-dwelling) will be randomized in either LiFE or gLiFE. Both groups will undergo the same strength and balance activities as well as PA promotion activities and habitualization strategies as described in the LiFE programme, however, based on different approaches of delivery: During the 6-month intervention phase, LiFE participants will receive seven home visits and two telephone calls; in gLiFE, the program will be delivered in seven group sessions and also two telephone calls. Main outcomes are a) fall incidence per PA and b) incremental cost-effectiveness ratio comparing costs and quality-adjusted life years between the two interventions. Secondary outcomes include PA behaviour, motor performance, health status, psychosocial status, program evaluation, and adherence. Measurements will be conducted at baseline, 6-month and 12-month follow-up; evaluation of intervention sessions and assessment of psychosocial variables related to execution and habitualization of LiFE activities will be made during the intervention period as well. DISCUSSION: Compared to LiFE, we expect gLiFE to (a) reduce falls per PA by a similar rate; (b) be more cost-effective; (c) comparably enhance physical performance in terms of strength and balance as well as PA. By investigating the economic and societal benefit, this study will be of high practical relevance as noninferiority of gLiFE would facilitate large-scale implementation due to lower resource usage. This would result in better reach and increased accessibility, which is important for subjects with a history of falls and/or being at risk of falls. TRIAL REGISTRATION: ClinicalTrials.gov NCT03462654 . Registered on March 12, 2018.

The Impact of Mild Cognitive Impairment on Gait and Balance: A Systematic Review and Meta-Analysis of Studies Using Instrumented Assessment.

BACKGROUND: In addition to cognitive deficits, people with mild cognitive impairment (MCI) can experience motor dysfunction, including deficits in gait and balance. Objective, instrumented motor performance assessment may allow the detection of subtle MCI-related motor deficits, allowing early diagnosis and intervention. Motor assessment under dual-task conditions may increase diagnostic accuracy; however, the sensitivity of different cognitive tasks is unclear. OBJECTIVE: To systematically review the extant literature focusing on instrumented assessment of gait and balance parameters for discriminating MCI patients from cognitively intact peers. METHODS: Database searches were conducted in PubMed, EMBASE, Cochrane Library, PsycINFO and Web of Science. Inclusion criteria were: (1) clinically confirmed MCI; (2) instrumented measurement of gait and/or balance; (3) English language, and (4) reporting gait or balance parameters which could be included in a meta-analysis for discriminating between MCI patients and cognitively intact individuals based on weighted effect size (d). RESULTS: Fourteen studies met the inclusion criteria and reported quantitative gait (n = 11) or postural balance (n = 4) parameters to be included in the meta-analysis. The meta-analysis revealed that several gait parameters including velocity (d = -0.74, p < 0.01), stride length (d = -0.65, p < 0.01), and stride time (mean: d = 0.56, p = 0.02; coefficient of variation: d = 0.50, p < 0.01) discriminated best between MCI and healthy controls under single-task conditions. Importantly, dual-task assessment increased the discriminative power of gait variables wherein gait variables with counting tasks appeared to be more sensitive (range d = 0.84-1.35) compared to verbal fluency tasks such as animal naming (range d = 0.65-0.94). Balance parameters identified as significant discriminators were anterior-posterior (d = 0.49, p < 0.01) and mediolateral (d = -0.34, p = 0.04) sway position in the eyes-open condition but not eyes-closed condition. CONCLUSION: Existing studies provide evidence that MCI affects specific gait parameters. MCI-related gait changes were most pronounced when subjects are challenged cognitively (i.e., dual task), suggesting that gait assessment with an additional cognitive task is useful for diagnosis and outcome analysis in the target population. Static balance seems to also be affected by MCI, although limited evidence exists. Instrumented motor assessment could provide a critical opportunity for MCI diagnosis and tailored intervention targeting specific deficits and potentially slowing progression to dementia. Further studies are required to confirm our findings.

Wearable sensor-based in-home assessment of gait, balance, and physical activity for discrimination of frailty status: baseline results of the Arizona frailty cohort study.

BACKGROUND: Frailty is a geriatric syndrome resulting from age-related cumulative decline across multiple physiologic systems, impaired homeostatic reserve, and reduced capacity to resist stress. Based on recent estimates, 10% of community-dwelling older individuals are frail and another 41.6% are prefrail. Frail elders account for the highest health care costs in industrialized nations. Impaired physical function is a major indicator of frailty, and functional performance tests are useful for the identification of frailty. Objective instrumented assessments of physical functioning that are feasible for home frailty screening have not been adequately developed. OBJECTIVE: To examine the ability of wearable sensor-based in-home assessment of gait, balance, and physical activity (PA) to discriminate between frailty levels (nonfrail, prefrail, and frail). METHODS: In an observational cross-sectional study, in-home visits were completed in 125 older adults (nonfrail: n=44, prefrail: n=60, frail: n=21) living in Tucson, Ariz., USA, between September 2012 and November 2013. Temporal-spatial gait parameters (speed, stride length, stride time, double support, and variability of stride velocity), postural balance (sway of hip, ankle, and center of mass), and PA (percentage of walking, standing, sitting, and lying; mean duration and variability of single walking, standing, sitting, and lying bouts) were measured in the participant's home using validated wearable sensor technology. Logistic regression was used to assess the most sensitive gait, balance, and PA variables for identifying prefrail participants (vs. nonfrail). Multinomial logistic regression was used to identify variables sensitive to discriminate between three frailty levels. RESULTS: Gait speed (area under the curve, AUC=0.802), hip sway (AUC=0.734), and steps/day (AUC=0.736) were the most sensitive parameters for the identification of prefrailty. Multinomial regression revealed that stride length (AUC=0.857) and double support (AUC=0.841) were the most sensitive gait parameters for discriminating between three frailty levels. Interestingly, walking bout duration variability was the most sensitive PA parameter for discriminating between three frailty levels (AUC=0.818). No balance parameter discriminated between three frailty levels. CONCLUSION: Our results indicate that unique parameters derived from objective assessment of gait, balance, and PA are sensitive for the identification of prefrailty and the classification of a subject's frailty level. The present findings highlight the potential of wearable sensor technology for in-home assessment of frailty status.

Should mycophenolate mofetil replace cyclophosphamide as first-line therapy for severe lupus nephritis?

Available treatments for severe (class III, IV, and V) lupus nephritis (LN) have expanded greatly over the last 40 years. In the 1970s and 1980s, cyclophosphamide (CYC), in combination with glucocorticoids, gained favor as induction and maintenance therapy for severe LN. However, the adverse event profile of CYC led to the search for other medications for severe LN. Beginning in the late 1990 s, mycophenolate mofetil (MMF) was introduced as induction and maintenance therapy for severe LN. This review discusses the clinical trial results, pharmacology, cost-effectiveness, and adverse effect profiles of CYC compared to MMF for induction and maintenance therapy for severe LN. The authors conclude that MMF should be considered first-line induction and maintenance treatment therapy for severe LN, although CYC may have a place under specific clinical and economic circumstances.

Assessment of physical activity in older people with and without cognitive impairment.

The purpose of this study was to validate a new interview-administered physical activity questionnaire (Assessment of Physical Activity in Frail Older People; APAFOP) in older people with and without cognitive impairment. The authors assessed feasibility, validity, and test-retest reliability in 168 people (n = 78 with, n = 88 without cognitive impairment). Concurrent validity was assessed against an inertia-based motion sensor and an established questionnaire. Sensitivity to change was tested in an ongoing study in patients with mild to moderate dementia (n = 81). Assessment of physical activity by the APAFOP and the motion sensor correlated well in the total sample (TS; p = .705), as well as in the subsamples with cognitive impairment (CI; p = .585) and without CI (p = .787). Excellent feasibility with an acceptance rate of 100%, test-retest reliability (intraclass correlation coefficients ranging from .973 (TS) to .975 (CI) to .966 (no CI), and sensitivity to change (effect sizes: 0.35-1.47) were found in both subsamples.

Rollator use adversely impacts on assessment of gait and mobility during geriatric rehabilitation.

OBJECTIVE: To investigate the influence of the use of a rollator walking aid on assessment of gait and mobility. DESIGN: Prospective, longitudinal study. SUBJECTS: Geriatric patients during inpatient rehabilitation (n=109; mean age 83.1 years). METHODS: Assessment at the beginning and prior to discharge from rehabilitation using: gait-analysis (GAITRite®, speed, cadence, stride-time, stride-length, base-of-support, double-support), Performance-Oriented-Mobility-Assessment (POMA), and Timed-Up-and-Go (TUG). Differences between outcomes obtained without and with rollator use were calculated for baseline assessment and for changes over time for the total group and subgroups according to diagnosis (hip fracture vs. other). Responsiveness was calculated using standardized response means. RESULTS: Baseline performances were significantly (p ≤ 0.05) higher when assessed with vs. without rollator in the total group and in hip fracture (except cadence) and other (except cadence, stride-time, TUG) patients. Changes over time were significantly greater when assessed without vs. with rollator in the total group and hip fracture (except cadence, POMA) and other patients (except base-of-support, double-support). Tests without rollator showed superior responsiveness (except TUG). CONCLUSION: The use of rollator walking aids limits the detection of initial gait and mobility deficits, adversely affects the assessment of changes over time in gait and mobility performance, and reduces the responsiveness of tests. When full weight-bearing is permitted, assessment without a walking aid is recommended.