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Serious adverse events of older adults in nursing home and community intervention trials.

ABSTRACT: Background/Aims:Clinical trials of older adults are increasingly common, but risks of serious adverse events (SAE) may vary. We describe the incidence of SAE in two randomized trials, one community-based and one nursing home-based. Methods:We performed a secondary data analysis from two randomized clinical trials at one academic health center and 21 nursing homes involving 200 sedentary community dwellers aged 70-89 years and 185 female nursing home residents aged 65 years or older. Interventions included structured physical activity to reduce mobility disability in the Lifestyle Interventions and Independence for Elders (LIFE) study and oral cranberry capsules to reduce bacteriuria plus pyuria in nursing home residents (CRANNY) trial. We measured SAE incidence per 100 person-years and incidence of protocol-related unanticipated SAE per 100 person-years in LIFE and CRANNY trials. Results:Mean age and proportion of patients with dementia in LIFE and CRANNY trials were 79.3 years and 86.4 years and 0% and 78%, respectively. There were 179 total SAE in LIFE including 8 (4%) deaths, and 116 total SAE in CRANNY including 33 (28%) deaths. SAE incidence was 33.7 (95% CI 27.2, 41.8) events per 100 person-years in LIFE and 69.4 (95% CI 49.1, 98.1) events per 100 person-years in CRANNY. No protocol-related unanticipated SAE occurred in either trial. Conclusions:The frequency and severity of SAE vary in older adults. While SAE are common in nursing home residents, protocol-related, unanticipated SAE are rare in nursing home residents and community dwellers. This finding can inform trial monitoring protocols. Trial registration:ClinicalTrials.gov identifiers: NCT01072500 and NCT01691430.

SUBMITTER: Datta R

PROVIDER: S-EPMC5898490 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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Serious adverse events of older adults in nursing home and community intervention trials.

Datta Rupak R Trentalange Mark M Van Ness Peter H PH McGloin Joanne M JM Guralnik Jack M JM Miller Michael E ME Walkup Michael P MP Nadkarni Neelesh N Pahor Marco M Gill Thomas M TM Quagliarello Vincent V Juthani-Mehta Manisha M

Contemporary clinical trials communications 20171221

<h4>Background/aims</h4>Clinical trials of older adults are increasingly common, but risks of serious adverse events (SAE) may vary. We describe the incidence of SAE in two randomized trials, one community-based and one nursing home-based.<h4>Methods</h4>We performed a secondary data analysis from two randomized clinical trials at one academic health center and 21 nursing homes involving 200 sedentary community dwellers aged 70-89 years and 185 female nursing home residents aged 65 years or olde ...[more]

PMID: 29696228

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Project description:BackgroundImmune Checkpoint Inhibitors (ICI) have been progressively used in cancer treatment and produced unique toxicity profiles. This systematic review aims to comprehend the patterns and occurrence of treatment-related adverse events (trAEs) based on ICI.MethodsPICOS/PRISMA methods were used to identify published English-language on PubMed, Web of Science, and Scopus from 2015 to 2020. Published clinical trials on ICI monotherapy, combined ICIs, and ICI plus other treatment with tabulated data on grade≥3 trAEs were included. Odds ratio (OR), χ2 tests were used to analyze for effect size and associations.ResultsThis review included 145 clinical trials involving 21786 patients. Grade 3-5 trAEs were more common with ICI when they were plused with other treatments compared with ICI monotherapy(54.3% versus 17.7%, 46.1%, p<0.05). Grade 3-5 trAEs were also more common with CTLA-4 mAbs compared with anti-PD-1 and anti-PD-L1 (34.2% versus 15.1%, 13.6%, p<0.05). Hyperthyroidism (OR 3.8, 95%CI 1.7-8.6), nausea (OR 3.7, 95%CI 2.5-5.3), diarrhea (OR 2.7, 95%CI 2.2-3.2), colitis (OR 3.4, 95%CI 2.7-4.3), ALT increase (OR 4.9, 95%CI 3.9-6.1), AST increase (OR 3.8, 95%CI 3.0-4.9), pruritus (OR 2.4, 95%CI 1.5-3.9), rash (OR 2.8, 95%CI 2.1-3.8), fatigue (OR 2.8, 95%CI 2.2-3.7), decreased appetite (OR 2.4, 95%CI 1.5-3.8), and hypophysitis (OR 2.0, 95%CI 1.2-3.3) were more frequent with combined ICIs. Diarrhea (OR 8.1, 95%CI 6.4-10.3), colitis (OR 12.2, 95%CI 8.7-17.1), ALT increase (OR 5.1, 95%CI 3.5-7.4), AST increase (OR 4.2, 95%CI 2.8-6.3), pruritus (OR 4.1, 95%CI 2.0-8.4), rash (OR 4.4, 95%CI 2.9-6.8), hypophysitis (OR 12.1, 95%CI 6.3-23.4) were more common with CTLA-4 mAbs; whereas pneumonitis (OR 4.7, 95% CI 2.1-10.3) were more frequent with PD-1 mAbs.ConclusionsDifferent immune checkpoint inhibitors are associated with different treatment-related adverse events profiles. A comprehensive data in this systematic review will provide comprehensive information for clinicians.

Project description:BackgroundIncreasing numbers of older people are receiving support with medicines management from community nursing services (CNSs) to enable them to live in their own homes. Little is known about these people and the support they receive.ObjectivesTo explore the characteristics of older people referred for medicines management support, type of support provided, medication errors and adverse medication events (AMEs).MethodsA retrospective observational study of a random sample of 100 older people referred to a large non-profit CNS for medicines management support over a 3-month period was conducted. Measures were: demographics, referral source, current medical problems, medicines, medication aids, types of medication authorisations used by nurses, frequency of nurse visits and type of support provided, medication errors, AMEs and interdisciplinary teamwork among community nurses, general practitioners and pharmacists.ResultsOlder people (median 80 years) were referred for medicines support most often by hospitals (39 %). Other referrals were from families/carers, case-managers, palliative care services and general practitioners. Multiple health conditions (median 5) and medicines (median 10) were common; 66 % used ≥5 medicines; 48 % used ≥1 high-risk medicines-most commonly opiates, anticoagulants and insulin. Medication aids were frequently used, mostly multi-compartment dose administration aids (47 %). Most people received regular community nurse visits (≥4 per week) to administer medicines or monitor medicine-taking. Only 16 % had a medication administration chart; for other clients nurses used medicine lists or letters from doctors for medication authorisation. Medication errors occurred in 41 % of people and 13 % had ≥1 AME requiring medical consultation or hospitalisation; 9/13 (64 %) AMEs were potentially preventable. There was little evidence of interdisciplinary teamwork or medication review.ConclusionCNS clients had multiple risk-factors for medication misadventure. Deficiencies in medicines management were identified, including low use of medication charts and interdisciplinary medication review. Strategies are needed to improve medicines management in the home-care setting.

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Serious adverse events of older adults in nursing home and community intervention trials.

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Serious adverse events of older adults in nursing home and community intervention trials.

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