Fall Incidence as the Primary Outcome in Multiple Sclerosis Falls-Prevention Trials: Recommendation from the International MS Falls Prevention Research Network.
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ABSTRACT:
SUBMITTER: Coote S
PROVIDER: S-EPMC4321456 | biostudies-other | 2014
REPOSITORIES: biostudies-other
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Project description:ObjectivesThe aim was to describe falls and the perceived causes, experienced by people with multiple sclerosis shortly after falling.DesignA qualitative study using content analysis and quantitative data to illustrate where and why people report falls most commonly. Semi-structured telephone interviews were performed. Interviews were conducted shortly (0-10 days) after a fall.SubjectsIn all, 67 informants who had reported at least one fall during the previous three-month period and who used a walking aid participated.ResultsA total of 57 (85%) informants fell at least once during eight months resulting in 115 falls; 90 (78%) falls happened indoors, most commonly in the kitchen ( n = 20; 17%) or bathroom ( n = 16; 14%). Informants fell during everyday activities and walking aids had been used in more than a third of the reported falls. The falls were influenced of both intrinsic and extrinsic factors. Two categories emerged from the analysis: 'activities when falling' and 'influencing factors'. The category contained three (basic activities of daily living, instrumental activities of daily living and leisure and work) and six (multiple sclerosis-related symptoms, fluctuating body symptoms, being distracted, losing body control, challenging surrounding and involvement of walking aid) subcategories, respectively.ConclusionThe majority of falls occurs indoors and in daily activities. Several factors interacted in fall situations and should be monitored and considered to reduce the gap between the person's capacity and the environmental demands that cause fall risk. Fluctuation of bodily symptoms between and within a day is a variable not earlier targeted in multiple sclerosis fall risk research.
| S-EPMC5865469 | biostudies-literature
Project description:BackgroundFalls are common in older adults and can lead to severe injuries. The Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) trial cluster-randomized 86 primary care practices across 10 health systems to a multifactorial intervention to prevent fall injuries, delivered by registered nurses trained as falls care managers, or enhanced usual care. STRIDE enrolled 5451 community-dwelling older adults age ≥70 at increased fall injury risk.MethodsWe assessed fall-related outcomes via telephone interviews of participants (or proxies) every 4 months. At baseline, 12 and 24 months, we assessed health-related quality of life (HRQOL) using the EQ-5D-5L and EQ-VAS. We used Poisson models to assess intervention effects on falls, fall-related fractures, fall injuries leading to hospital admission, and fall injuries leading to medical attention. We used hierarchical longitudinal linear models to assess HRQOL.ResultsFor recurrent event models, intervention versus control incidence rate ratios were 0.97 (95% confidence interval [CI], 0.93-1.00; p = 0.048) for falls, 0.93 (95% CI, 0.80-1.08; p = 0.337) for self-reported fractures, 0.89 (95% CI, 0.73-1.07; p = 0.205) for adjudicated fractures, 0.91 (95% CI, 0.77-1.07; p = 0.263) for falls leading to hospital admission, and 0.97 (95% CI, 0.89-1.06; p = 0.477) for falls leading to medical attention. Similar effect sizes (non-significant) were obtained for dichotomous outcomes (e.g., participants with ≥1 events). The difference in least square mean change over time in EQ-5D-5L (intervention minus control) was 0.009 (95% CI, -0.002 to 0.019; p = 0.106) at 12 months and 0.005 (95% CI, -0.006 to 0.015; p = 0.384) at 24 months.ConclusionsAcross a standard set of outcomes typically reported in fall prevention studies, we observed modest improvements, one of which was statistically significant. Future work should focus on patient-, practice-, and organization-level operational strategies to increase the real-world effectiveness of interventions, and improving the ability to detect small but potentially meaningful clinical effects.Clinicaltrialsgov identifier: NCT02475850.
| S-EPMC9669115 | biostudies-literature
Project description:ObjectivesPrevention of falls and fall-related injuries is a priority due to the substantial health and financial burden of falls on patients and healthcare systems. Deprescribing medications known as 'fall-risk increasing drugs' (FRIDs) is a common strategy to prevent falls. We conducted a systematic review to determine its efficacy for the prevention of falls and fall-related complications.DesignSystematic review and meta-analysis.Data sourcesMEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, CINAHL and grey literature from inception to 1 August 2020.Eligibility criteria for selecting studiesRandomised controlled trials of FRID withdrawal compared with usual care evaluating the rate of falls, incidence of falls, fall-related injuries, fall-related fractures, fall-related hospitalisations or adverse effects related to the intervention in adults aged ≥65 years.Data extraction and synthesisTwo reviewers independently performed citation screening, data abstraction, risk of bias assessment and certainty of evidence grading. Random-effects models were used for meta-analyses.ResultsFive trials involving 1305 participants met eligibility criteria. Deprescribing FRIDs did not change the rate of falls (rate ratio (RaR) 0.98, 95% CI 0.63 to 1.51), the incidence of falls (risk difference 0.01, 95% CI -0.06 to 0.09; relative risk 1.04, 95% CI 0.86 to 1.26) or rate of fall-related injuries (RaR 0.89, 95% CI 0.57 to 1.39) over a follow-up period of 6-12 months. No trials evaluated the impact of deprescribing FRIDs on fall-related fractures or hospitalisations.ConclusionThere is a paucity of robust high-quality evidence to support or refute that a FRID deprescribing strategy alone is effective at preventing falls or fall-related injury in older adults. Although there may be other reasons to deprescribe FRIDs, our systematic review found that it may result in little to no difference in the rate or risk of falls as a sole falls reduction strategy.Prospero registration numberCRD42016040203.
| S-EPMC7878138 | biostudies-literature
Project description:Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease with an average survival of 3-5 years. While therapies for ALS remain limited, basic and translational ALS research has been host to numerous influential discoveries in recent years. These discoveries have led to a large pipeline of potential therapies that await testing in clinical trials. Until recently, ALS clinical trials have relied on a limited cadre of 'traditional' outcome measures, including survival and measures of function. These measures have proven useful, although imperfect, in Phase III ALS trials. However, their utility in early-phase ALS trials is limited. For these early trials, outcome measures focused on target engagement or biological pathway analysis might improve trial outcomes and better support the drug development process.
| S-EPMC5305182 | biostudies-other
Project description:ObjectiveTo evaluate whether a service to prevent falls in the community would help reduce the rate of falls in older people who call an emergency ambulance when they fall but are not taken to hospital.DesignRandomised controlled trial.SettingCommunity covered by four primary care trusts, England.Participants204 adults aged more than 60 living at home or in residential care who had fallen and called an emergency ambulance but were not taken to hospital.InterventionsReferral to community fall prevention services or standard medical and social care.Main outcome measuresThe primary outcome was the rate of falls over 12 months, ascertained from monthly diaries. Secondary outcomes were scores on the Barthel index, Nottingham extended activities of daily living scale, and falls efficacy scale at baseline and by postal questionnaire at 12 months. Analysis was by intention to treat.Results102 people were allocated to each group. 99 (97%) participants in the intervention group received the intervention. Falls diaries were analysed for 88.6 person years in the intervention group and 84.5 person years in the control group. The incidence rates of falls per year were 3.46 in the intervention group and 7.68 in the control group (incidence rate ratio 0.45, 95% confidence interval 0.35 to 0.58, P<0.001). The intervention group achieved higher scores on the Barthel index and Nottingham extended activities of daily living and lower scores on the falls efficacy scale (all P<0.05) at the 12 month follow-up. The number of times an emergency ambulance was called because of a fall was significantly different during follow-up (incidence rate ratio 0.60, 95% confidence interval 0.40 to 0.92, P=0.018).ConclusionA service to prevent falls in the community reduced the fall rate and improved clinical outcome in the high risk group of older people who call an emergency ambulance after a fall but are not taken to hospital.Trial registrationCurrent Controlled Trials ISRCTN67535605.
| S-EPMC2868162 | biostudies-literature
Project description:Recent studies suggest that the RANK/RANKL system impacts muscle function and/or mass. In the pivotal placebo-controlled fracture trial of the RANKL inhibitor denosumab in women with postmenopausal osteoporosis, treatment was associated with a lower incidence of non-fracture-related falls (p = 0.02). This ad hoc exploratory analysis pooled data from five placebo-controlled trials of denosumab to determine consistency across trials, if any, of the reduction of fall incidence. The analysis included trials in women with postmenopausal osteoporosis and low bone mass, men with osteoporosis, women receiving adjuvant aromatase inhibitors for breast cancer, and men receiving androgen deprivation therapy for prostate cancer. The analysis was stratified by trial, and only included data from the placebo-controlled period of each trial. A time-to-event analysis of first fall and exposure-adjusted subject incidence rates of falls were analyzed. Falls were reported and captured as adverse events. The analysis comprised 10,036 individuals; 5030 received denosumab 60 mg subcutaneously once every 6 months for 12 to 36 months and 5006 received placebo. Kaplan-Meier estimates showed an occurrence of falls in 6.5% of subjects in the placebo group compared with 5.2% of subjects in the denosumab group (hazard ratio = 0.79; 95% confidence interval 0.66-0.93; p = 0.0061). Heterogeneity in study designs did not permit overall assessment of association with fracture outcomes. In conclusion, denosumab may reduce the risk of falls in addition to its established fracture risk reduction by reducing bone resorption and increasing bone mass. These observations require further exploration and confirmation in studies with muscle function or falls as the primary outcome. © 2020 The Authors. Journal of Bone and Mineral Research published by American Society for Bone and Mineral Research..
| S-EPMC9328365 | biostudies-literature
Project description:ObjectivePediatric studies for new biological agents are mandated by recent legislation, necessitating careful thought to evaluation of emerging multiple sclerosis (MS) therapies in children with MS. Challenges include a small patient population, the lack of prior randomized clinical trials, and ethical concerns. The goal of this meeting was to assess areas of consensus regarding clinical trial design and outcome measures among academic experts involved in pediatric MS care and research.MethodsThe Steering Committee of the International Pediatric MS Study Group identified key focus areas for discussion. A total of 69 meeting attendees were assembled, including 35 academic experts. Regulatory and pharmaceutical representatives also attended, and provided input, which informed academic expert consensus decisions.ResultsThe academic experts agreed that clinical trials were necessary in pediatric MS to obtain pharmacokinetic, safety and efficacy data, and regulatory approval allowing for greater medication access. The academic experts agreed that relapse was an appropriate primary outcome measure for phase III pediatric trials. An international standardized cognitive battery was identified. The pros and cons of various trial designs were discussed. Guidelines surrounding MRI studies, pharmacokinetics, pharmacodynamics, and registries were developed. The academic experts agreed that given the limited subject pool, a stepwise approach to the launch of clinical trials for the most promising medications is necessary in order to ensure study completion. Alternative approaches could result in unethical exposure of patients to trial conditions without gaining knowledge.ConclusionConsensus points for conduct of clinical trials in the rare disease pediatric MS were identified amongst a panel of academic experts, informed by regulatory and industry stakeholders.
| S-EPMC3662305 | biostudies-literature
Project description:ImportanceThere is insufficient research on the costs of patient falls in health care systems, a leading source of nonreimbursable adverse events.ObjectiveTo report the costs of inpatient falls and the cost savings associated with implementation of an evidence-based fall prevention program.Design, setting, and participantsIn this economic evaluation, a matched case-control study used the findings from an interrupted time series analysis that assessed changes in fall rates following implementation of an evidence-based fall prevention program to understand the cost of inpatient falls. An economic analysis was then performed to assess the cost benefits associated with program implementation across 2 US health care systems from June 1, 2013, to August 31, 2019, in New York, New York, and Boston, Massachusetts. All adults hospitalized in participating units were included in the analysis. Data analysis was performed from October 2021 to November 2022.InterventionsEvidence-based fall prevention program implemented in 33 medical and surgical units in 8 hospitals.Main outcomes and measuresPrimary outcome was cost of inpatient falls. Secondary outcome was the costs and cost savings associated with the evidence-based fall prevention program.ResultsA total of 10 176 patients who had a fall event (injurious or noninjurious) with 29 161 matched controls (no fall event) were included in the case-control study and the economic analysis (51.9% were 65-74 years of age, 67.1% were White, and 53.6% were male). Before the intervention, there were 2503 falls and 900 injuries; after the intervention, there were 2078 falls and 758 injuries. Based on a 19% reduction in falls and 20% reduction in injurious falls from the beginning to the end of the postintervention period, the economic analysis demonstrated that noninjurious and injurious falls were associated with cost increases of $35 365 and $36 776, respectively. The implementation of the evidence-based fall prevention program was associated with $14 600 in net avoided costs per 1000 patient-days.Conclusions and relevanceThis economic evaluation found that fall-related adverse events represented a clinical and financial burden to health care systems and that the current Medicare policy limits reimbursement. In this study, costs of falls only differed marginally by injury level. Policies that incentivize organizations to implement evidence-based strategies that reduce the incidence of all falls may be effective in reducing both harm and costs.
| S-EPMC9860521 | biostudies-literature
Project description:IntroductionClinical trials evaluating the effectiveness of falls prevention interventions for people with Multiple Sclerosis (MS), Parkinson's Disease (PD) and stroke measure heterogeneous outcomes, often omitting those meaningful to patients. A core outcome set (COS) is a standardised set of outcomes that should be assessed in all trials within a research area. The aim of this study was to develop a COS for evaluating mixed-diagnosis falls prevention interventions for people with MS, PD and stroke in non-acute and community settings, with input from relevant stakeholder groups.MethodsPreviously published research undertaken by the team, including a qualitative study with 20 patients and a review of the literature, were used to derive a longlist of potential outcomes. Outcomes were prioritised for inclusion in the COS using a three-round online Delphi survey. A multi-stakeholder, consensus meeting was conducted to agree upon the final COS and to provide a recommendation for a single outcome measure for each outcome in the COS.ResultsForty-eight participants were recruited across four stakeholder groups (researchers, patients, clinicians, and service-planners/policymakers). A total of 42 participants (87.5%) completed all three rounds of the surveys. Sixty-two outcomes were considered for inclusion in the COS throughout the Delphi process. A total of 15 participants attended the consensus meeting where they agreed upon the final COS and accompanying measurement instruments: fall incidence, injurious fall incidence, quality of life, falls self-efficacy, fear of falling, activity curtailment due to fear of falling, and cost-effectiveness. Attendees at the consensus meeting recommended that the proposed mechanism of impact of an intervention is considered when selecting additional outcomes outside of those in the COS to assess.ConclusionsThis study identified a COS for evaluating the effectiveness of mixed-diagnosis falls prevention interventions for people with MS, PD and stroke. It is recommended that this COS and accompanying measurement instruments be used in all future trials in this research area so that findings can be combined and compared.
| S-EPMC10642845 | biostudies-literature
Project description:Imaging markers that are reliable, reproducible and sensitive to neurodegenerative changes in progressive multiple sclerosis (MS) can enhance the development of new medications with a neuroprotective mode-of-action. Accordingly, in recent years, a considerable number of imaging biomarkers have been included in phase 2 and 3 clinical trials in primary and secondary progressive MS. Brain lesion count and volume are markers of inflammation and demyelination and are important outcomes even in progressive MS trials. Brain and, more recently, spinal cord atrophy are gaining relevance, considering their strong association with disability accrual; ongoing improvements in analysis methods will enhance their applicability in clinical trials, especially for cord atrophy. Advanced magnetic resonance imaging (MRI) techniques (e.g. magnetization transfer ratio (MTR), diffusion tensor imaging (DTI), spectroscopy) have been included in few trials so far and hold promise for the future, as they can reflect specific pathological changes targeted by neuroprotective treatments. Positron emission tomography (PET) and optical coherence tomography have yet to be included. Applications, limitations and future perspectives of these techniques in clinical trials in progressive MS are discussed, with emphasis on measurement sensitivity, reliability and sample size calculation.
| S-EPMC5650056 | biostudies-literature