A proposal for the retrospective identification and categorization of older people with functional impairments in scientific studies : recommendations of the Medication and Quality of Life in Frail Older Persons (MedQoL) research group

When treating older adults, a main factor to consider is physical frailty. Because specific assessments in clinical trials are frequently lacking, critical appraisal of treatment evidence with respect to functional status is challenging. Our aim was to identify and categorize assessments for functional status given in clinical trials in older adults to allow for a retrospective characterization and indirect comparison of treatment evidence from these cohorts. We conducted 4 separate systematic reviews of randomized and nonrandomized controlled clinical trials in older people with hypertension, diabetes, depression, and dementia. All assessments identified that reflected functional status were analyzed. Assessments were categorized across 4 different functional status levels. These levels span from functionally not impaired, slightly impaired, significantly impaired, to severely impaired/disabled. If available from the literature, cut-offs for these 4 functioning levels were extracted. If not, or if the existing cut-offs did not match the predefined functional levels, cut-off points were defined by an expert group composed of geriatricians, pharmacists, pharmacologists, neurologists, psychiatrists, and epidemiologists using a patient-centered approach. We identified 51 instruments that included measures of functional status. Although some of the assessments had clearly defined cut-offs across our predefined categories, many others did not. In most cases, no cut-offs existed for slightly impaired or severely impaired older adults. Missing cut-offs or values to adjust were determined by the expert group and are presented as described. The functional status assessments that were identified and operationalized across 4 functional levels could now be used for a retrospective characterization of functional status in randomized controlled trials and observational studies. Allocated categories only serve as approximations and should be validated head-to-head in future studies. Moreover, as general standard, upcoming studies involving older adults should include and explicitly report functional impairment as a baseline characteristic of all participants enrolled

Additional file 1: of Understanding adverse drug reactions in package leaflets – an exploratory survey among health care professionals

PDF-document (.pdf), questionnaires and supplementary data on convenience samples and their knowledge on EbM. (PDF 272 kb

Alternative package leaflets improve people's understanding of drug side effects-A randomized controlled exploratory survey.

BACKGROUND:Current German and EU package leaflets (PLs) do not distinguish to what extent listed side effects are indeed side effects caused by drug intake or instead symptoms that occur regardless of drug use. We recently showed that most health professionals misinterpret the frequencies of listed side effects as solely caused by the drug. The present study investigated whether (1) these misinterpretations also prevail among laypeople and (2) alternative PLs reduce these misinterpretations. METHODS:In March 2017, 397 out of 400 laypeople approached completed an online survey. They were randomized to one of four PL formats: three alternative PLs (drug facts box with/without reading instruction, narrative format with numbers) and one standard PL. Each PL listed four side effects for a fictitious drug: two were presented as occurring more often, one as equally often, and one as less often with drug intake. The alternative formats (interventions) included information on frequencies with and without drug intake and included a statement on the causal relation. The standard PL (control) only included information on frequency ranges with drug intake. Questions were asked on general occurrence and causality of side effects. RESULTS:Participants randomized to the standard PL were unable to answer questions on causality. For side effects occurring more often (equally; less often) with drug intake, only 1.9% to 2.8% (equally: 1.9%; less often: 1.9%) provided correct responses about the causal nature of side effects, compared to 55.0% to 81.9% (equally: 23.8% to 70.5%; less often: 21.0% to 43.2%) of participants who received alternative PLs. It remains unclear whether one alternative format is superior to the others. CONCLUSION:In conclusion, information on the frequency of side effects in current package leaflets is misleading. Comparative presentation of frequencies for side effects with and without drug intake including statements on the causal relation significantly improves understanding

Communicating prognosis to women with early breast cancer – overview of prediction tools and the development and pilot testing of a decision aid

Abstract Background Shared decision-making in oncology requires information on individual prognosis. This comprises cancer prognosis as well as competing risks of dying due to age and comorbidities. Decision aids usually do not provide such information on competing risks. We conducted an overview on clinical prediction tools for early breast cancer and developed and pilot-tested a decision aid (DA) addressing individual prognosis using additional chemotherapy in early, hormone receptor-positive breast cancer as an example. Methods Systematic literature search on clinical prediction tools for the effects of drug treatment on survival of breast cancer. The DA was developed following criteria for evidence-based patient information and International Patient Decision Aids Standards. We included data on the influence of age and comorbidities on overall prognosis. The DA was pilot-tested in focus groups. Comprehension was additionally evaluated through an online survey with women in breast cancer self-help groups. Results We identified three prediction tools: Adjuvant!Online, PREDICT and CancerMath. All tools consider age and tumor characteristics. Adjuvant!Online considers comorbidities, CancerMath displays age-dependent non-cancer mortality. Harm due to therapy is not reported. Twenty women participated in focus groups piloting the DA until data saturation was achieved. A total of 102 women consented to participate in the online survey, of which 86 completed the survey. The rate of correct responses was 90.5% and ranged between 84 and 95% for individual questions. Conclusions None of the clinical prediction tools fulfilled the requirements to provide women with all the necessary information for informed decision-making. Information on individual prognosis was well understood and can be included in patient decision aids

The Effectiveness of Assistive Technologies for Older Adults and the Influence of Frailty: Systematic Literature Review of Randomized Controlled Trials

BackgroundThe use of assistive technologies (ATs) to support older people has been fueled by the demographic change and technological progress in many countries. These devices are designed to assist seniors, enable independent living at home or in residential facilities, and improve quality of life by addressing age-related difficulties. ObjectiveWe aimed to evaluate the effectiveness of ATs on relevant outcomes with a focus on frail older adults. MethodsA systematic literature review of randomized controlled trials evaluating ATs was performed according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. The Ovid Medline, PsycINFO, SocIndex, CINAHL (Cumulative Index to Nursing and Allied Health Literature), CENTRAL (Cochrane Central Register of Controlled Trials), and IEEEXplore databases were searched from January 1, 2009, to March 15, 2019. ATs were included when aiming to support the domains autonomy, communication, or safety of older people with a mean age ≥65 years. Trials performed within a laboratory setting were excluded. Studies were retrospectively categorized according to the physical frailty status of participants. ResultsA total of 19 trials with a high level of heterogeneity were included in the analysis. Six device categories were identified: mobility, personal disease management, medication, mental support, hearing, and vision. Eight trials showed significant effectiveness in all or some of the primary outcome measures. Personal disease management devices seem to be the most effective, with four out of five studies showing significant improvement of disease-related outcomes. Frailty could only be assessed for seven trials. Studies including participants with significant or severe impairment showed no effectiveness. ConclusionsDifferent ATs show some promising results in well-functioning but not in frail older adults, suggesting that the evaluated ATs might not (yet) be suitable for this subgroup. The uncertainty of the effectiveness of ATs and the lack of high-quality research for many promising supportive devices were confirmed in this systematic review. Large studies, also including frail older adults, and clear standards are needed in the future to guide professionals, older users, and their relatives. Trial RegistrationPROSPERO CRD42019130249; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=13024