Establishing the minimal clinically important difference of the EQ-5D-3L in older adults with a history of falls.

PURPOSE: Establish the minimal clinically important difference (MCID) of a health-related quality of life (HRQoL) measure-the EuroQol EQ-5 Dimensions-3 Level (EQ-5D-3L)-in older adults with a history of falls. METHODS: This study is a secondary analysis of 255 complete cases who were enrolled in a 12-month randomized controlled trial (NCT01029171; NCT00323596); participants were randomized to the Otago Exercise Program (OEP; n = 126/172; Age:81.2 ± 6.2 years; 60.3% Female) or control (CON; n = 129/172; Age:81.7 ± 5.7 years; 70.5% Female). Participants completed the EQ-5D-3L and Visual Analogue Scale (VAS) at baseline and 1-year. The VAS was associated with HRQoL and was the health status anchor (VAS minimal improvement = 7 to 17, maximal improvement ≥ 18, minimal decline = - 7 to - 17, maximal decline ≤ - 18 points). We used four distinct approaches to estimate MCID ranges: (1) anchor-based change differences of the EQ-5D-3L (1-year minus baseline); (2) anchor-based beta coefficients from ordinary least squares regressions (OLS); (3) anchor-based receiver operating characteristic (ROC), and 4) distribution-based standard deviation and standardized effect size of 0.5. RESULTS: EQ-5D-3L MCID ranges for minimal improvements (OEP = 0.028 to 0.059; CON = 0.007 to 0.051), maximal improvements (OEP = 0.059 to 0.090; CON = 0.051 to 0.090), minimal declines (OEP = - 0.029 to - 0.105; CON = - 0.015 to - 0.051), and maximal declines (OEP = - 0.018 to - 0.072; CON = - 0.018 to - 0.082) were established using change difference, OLS, and distribution-based methods. The ROC area under the curve was poor, thus, it was not used to estimate the MCID. CONCLUSIONS: Our results will assist in the interpretation of changes in HRQoL, as measured by the EQ-5D-3L, in older adults with a history of falls.

Baseline health-related quality of life predicts falls: a secondary analysis of a randomized controlled trial.

PURPOSE: Among older adults, health-related quality of life (HRQoL) and falls are associated. Generic patient-reported outcomes measures (PROMs) assess individual's HRQoL. The role for PROMs, a potential tool for predicting subsequent falls, remains under-explored. Our primary aim was to determine whether a baseline PROMs assessment of HRQoL may be a useful tool for predicting future falls. METHODS: A secondary analysis of a 12-month randomized clinical trial (RCT) of a home-based exercise program among 344 adults (67% female), aged ≥ 70 years, with ≥ 1 falls in the prior year who were randomized (1:1) to either a home-based exercise program (n = 172) or usual care (n = 172). A negative binomial regression model with total falls count as the dependent variable evaluated the main effect of the independent variable-baseline HRQoL (measured by the Short-Form-6D)-controlling for total exposure time and experiment group (i.e., exercise or usual care) for the total sample. For the usual care group alone, the model controlled for total exposure time. RESULTS: For the total sample, the rate of subsequent total falls was significantly predicted by baseline HRQoL (IRR = 0.044; 95% CI [0.005-0.037]; p = .004). For the usual care group, findings were confirmed with wider confidence intervals and the rate of prospective total falls was significantly predicted by baseline HRQoL (IRR = 0.025; 95% CI [0.001-0.909]; p = .044). CONCLUSION: These findings suggest the ShortForm-6D should be considered as part of falls prevention screening strategies within a Falls Prevention Clinic setting. Trial Registrations ClinicalTrials.gov Protocol Registration System. Identifier: NCT01029171; URL: https://clinicaltrials.gov/ct2/show/NCT01029171 . Identifier: NCT00323596; URL: https://clinicaltrials.gov/ct2/show/NCT00323596 .

Minimal Clinically Important Difference of Executive Function Performance in Older Adults Who Fall: A Secondary Analysis of a Randomized Controlled Trial.

INTRODUCTION: Executive function is responsive to exercise and predictive of subsequent falls. Minimal clinically important differences (MCIDs) are critical for understanding whether observed changes are meaningful. However, MCIDs of many cognitive measures are not established. We aimed to determine MCIDs of the Digit Symbol Substitution Test ([DSST] processing speed measure), Stroop (inhibition measure), and Trail Making Test B-A (TMT; set-shifting measure), using anchor- and distribution-based approaches in older adults who have fallen and received the Otago Exercise Program (OEP) relative to usual care only (CON). Our secondary aim was to establish construct (convergent and divergent) validity of these measures. METHODS: Complete case analyses of cognitive outcomes (DSST, Stroop, TMT, and Montreal Cognitive Assessment [MoCA]) were acquired at baseline and 1 year (NCT01029171; NCT003235960); participants were randomized to the OEP (n = 114/172; Age: 80.6 ± 6.1 years; 64.9% Female) or CON (n = 128/172; Age: 82.3 ± 5.8 years; 71.9% Female)]. The MoCA was used as the anchor. We estimated MCIDs using anchor- and distribution-based approaches. Anchor-based executive function change differences ([CD] 1 year minus baseline) observed in participants with meaningful changes in the MoCA (≥3 or ≤ -3 points) receiving the OEP were subtracted from the CON. An anchor-based receiver operator characteristic (ROC) curve was employed to identify optimal cut-off scores of the 3 executive function measures. The distribution-based approach (DA) accounted for variability in baseline and follow-up data. MCID ranges were estimated using these approaches. We used Spearman's correlations to explore convergent validity between executive function measures and other measures involving the same construct (DSST, Stroop, TMT, MoCA, and Mini-Mental State Examination), and divergent validity between executive function measures and variables reflecting different constructs (Geriatric Depression Scale, Instrumental Activities of Daily Living, sex, and body mass index). RESULTS: Based on the 3 approaches, MCID improvement ranges were 3-5 symbols for the DSST (CD = 5; ROC = 2.5; DA = 3.3 symbols), and -11.5 to -26.0 s for the Stroop (CD = -26.0; ROC = -11.5; DA = -20.6 s). MCID decline ranges were -3 to -6 symbols for the DSST (CD = -5.2; ROC = -2.5; DA = -3.3 symbols) and 5.4-30.6 s for the Stroop (CD = 30.6; ROC = 5.4; DA = 20.6 s). MCIDs for the TMT were not meaningful due to high variability (Improvement: CD = -106.6; ROC = -18.4; DA = -69.1 s; Decline: CD = 69.1; ROC = 14.5; DA = 69.1 s). The executive function measures exhibited good convergent (r = -0.22 to r = 0.42) and divergent (r < -0.01 to r = 0.16) validity. CONCLUSIONS: These established MCIDs will allow clinicians to interpret meaningful changes in executive function following exercise amongst older adults who have fallen. The DSST, Stroop, and TMT demonstrated good construct validity, supporting their use in comprehensive fall-risk assessments in older adults who fall.

Comparing the cost-effectiveness of the Otago Exercise Programme among older women and men: A secondary analysis of a randomized controlled trial.

OBJECTIVE: Using stratified analyses, we examined the cost-effectiveness of the Otago Exercise Programme (OEP), from a health care system perspective, among older women and men who have previously fallen. METHODS: This study was a secondary stratified analysis (by women and men), of a 12-month prospective economic evaluation of a randomized clinical trial (OEP compared with usual care). Three hundred and forty four community-dwelling older adults (≥70; 172 OEP (110 women; 62 men), 172 usual care (119 women; 53 men)) who sustained a fall in the past 12 months and received a baseline assessment at the Vancouver Falls Prevention Clinic, Canada were included. A gender by OEP/usual care interaction was examined for the falls incidence rate ratio (IRR). Outcome measures stratified by gender included: falls IRR, incremental cost-per fall prevented (ICER), incremental cost per quality adjusted life year (QALY, ICUR) gained, and mean total health care resource utilization costs. RESULTS: Men were frailer than women at baseline. Men incurred higher mean total healthcare costs $6794 (SD: $11906)). There was no significant gender by OEP/usual care interaction on falls IRR. The efficacy of the OEP did not vary by gender. The adjusted IRR for the OEP group demonstrated a 39% (IRR: 0.61, CI: 0.40-0.93) significant reduction in falls among men but not women (32% reduction (IRR: 0.69, CI: 0.47-1.02)). The ICER showed the OEP was effective in preventing falls and less costly for men, while it was costlier for women by $42. The ICUR showed the OEP did not impact quality of life. CONCLUSION: Future studies should explore gender factors (i.e., health seeking behaviours, gender related frailty) that may explain observed variation in the cost-effectiveness of the OEP as a secondary falls prevention strategy. TRIAL REGISTRATIONS: ClinicalTrials.gov Protocol Registration System Identifier: NCT01029171; URL: https://clinicaltrials.gov/ct2/show/NCT01029171 Identifier: NCT00323596; URL: https://clinicaltrials.gov/ct2/show/NCT00323596.

A 'case-mix' approach to understand adherence trajectories for a falls prevention exercise intervention: A longitudinal cohort study.

OBJECTIVE: We identified adherence-based case-mixes from participants' longitudinal adherence to falls prevention exercise interventions over 12 months. Second, we identified modifiable baseline predictors (cognition, mobility and functional status) based on participants' case-mix adherence trajectories. STUDY DESIGN AND OUTCOME MEASURES: This study was a 12-month longitudinal secondary analysis of data from 172 participants who received the Otago Exercise Program (OEP) in a randomized controlled trial. Adherence to the OEP was ascertained monthly via self-report. Case-mixes, groups of individuals who followed similar adherence trajectories, were visually defined using 12-month longitudinal trajectories; we used latent class growth modeling. Baseline predictors of adherence were examined for the following categories: 1) cognition, 2) mobility and 3) functional status. RESULTS: Four distinct case-mixes were identified. The "non-adherent" case-mix (18 %) was distinguished by a non-adherent and decreasing adherence trajectory over time. The "low adherence" case-mix (45 %) did not have complete adherence or consistent adherence over the 12-month follow-up. The "moderate adherence" case-mix (27 %) was characterized by a stable (i.e., non-variable) adherence trajectory with a slightly increasing pattern at midpoint. The "high adherence" case-mix (10 %) demonstrated consistent and high adherence over the 12-month follow-up. For individuals with "moderate adherence", the Digit Symbol Substitution Test (DSST) significantly predicted adherence (relative risk ratio (RRR) = 1.12 (0.95 CI: 1.0-1.26); p = 0.049). For individuals with "high adherence", the Digits Forward minus Digits Backward (RRR = 0.43 (0.95 CI: 0.23-0.79); p = 0.002) and Instrumental Activities of Daily Living (RRR = 0.36 (0.95 CI: 0.16-0.81); p = 0.01) significantly predicted adherence. CONCLUSIONS: Cognitive profile and activities of daily living at baseline may predict the longitudinal pattern of adherence.

Geriatrician-led evidence-based Falls Prevention Clinic: a prospective 12-month feasibility and acceptability cohort study among older adults.

OBJECTIVE: We assessed the feasibility and acceptability of delivering a geriatrician-led evidence-based Falls Prevention Clinic to older adults with a history of falls. DESIGN: 12-month prospective cohort study. SETTING: Vancouver Falls Prevention Clinic, Vancouver, British Columbia, Canada (www.fallsclinic.ca). PARTICIPANTS: 188 community-dwelling older adults aged ≥70 years who received a baseline assessment at the Vancouver Falls Prevention Clinic due to having had at least one fall resulting in medical attention in the previous 12 months. Fifty-six per cent of participants were also participating in a randomised controlled trial. MEASUREMENTS: Feasibility was ascertained by measuring demand (clinic attendance). Acceptability was measured by compliance with recommendations, completion of monthly fall calendars and patient experience. RESULTS: The attendance was 65% of those eligible and invited. This indicates feasibility for demand. 155 received at least one of the following clinical management recommendations from four domains (compliance reported in %): (1) medication changes (78%); (2) exercise prescription (58%); (3) referrals to other healthcare professionals (78%); and/or (4) lifestyle modifications (35%) excluding exercise. Overall compliance to all recommendations was 69%. Patient experience was related to factors impacting patient perceived physical benefit and attributes influencing patient satisfaction. CONCLUSION: This study demonstrated the feasibility and acceptability of a multifactorial intervention approach based on best available evidence-based medicine.