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RESEARCH PRODUCT
External validity of randomized controlled trials in older adults, a systematic review.
Alexander B. PothofKaren BroekhuizenIris PostmusDanielle J Van Der HamFloor J. Van DeudekomSimon P. MooijaartGerard J. Blauwsubject
MaleAgingMedical DoctorsHealth Care ProvidersPhysical fitnessPatient characteristicslcsh:MedicineSocial EnvironmentGeriatric Depressionlaw.invention0302 clinical medicineElderlyRandomized controlled triallawMedicine and Health SciencesMedicineMental Competency030212 general & internal medicinelcsh:ScienceRandomized Controlled Trials as TopicAged 80 and overeducation.field_of_studyMultidisciplinaryFrailtyDepressionResearch AssessmentMiddle AgedProfessions030220 oncology & carcinogenesisFemaleResearch Articlemedicine.medical_specialtyDrug Research and DevelopmentSystematic ReviewsFrail ElderlyPopulationGeriatric PsychiatryMEDLINEResearch and Analysis MethodsExternal validity03 medical and health sciencesPhysiciansMental Health and PsychiatryHumansClinical TrialseducationGeriatric AssessmentAgedPharmacologyDescriptive statisticsbusiness.industryMood Disorderslcsh:RSocial environmentRandomized Controlled TrialsHealth CareGeriatricsAge GroupsPhysical FitnessPeople and PlacesPhysical therapyPopulation Groupingslcsh:QGeriatric CareClinical Medicinebusinessdescription
Background To critically assess the external validity of randomized controlled trials (RCTs) it is important to know what older adults have been enrolled in the trials. The aim of this systematic review is to study what proportion of trials specifically designed for older patients report on somatic status, physical and mental functioning, social environment and frailty in the patient characteristics. Methods PubMed was searched for articles published in 2012 and only RCTs were included. Articles were further excluded if not conducted with humans or only secondary analyses were reported. A random sample of 10% was drawn. The current review analyzed this random sample and further selected trials when the reported mean age was ≥ 60 years. We extracted geriatric assessments from the population descriptives or the in- and exclusion criteria. Results In total 1396 trials were analyzed and 300 trials included. The median of the reported mean age was 66 (IQR 63-70) and the median percentage of men in the trials was 60 (IQR 45-72). In 34% of the RCTs specifically designed for older patients somatic status, physical and mental functioning, social environment or frailty were reported in the population descriptives or the in- and exclusion criteria. Physical and mental functioning was reported most frequently (22% and 14%). When selecting RCTs on a mean age of 70 or 80 years the report of geriatric assessments in the patient characteristics was 46% and 85% respectively but represent only 5% and 1% of the trials. Conclusion Somatic status, physical and mental functioning, social environment and frailty are underreported even in RCTs specifically designed for older patients published in 2012. Therefore, it is unclear for clinicians to which older patients the results can be applied. We recommend systematic to transparently report these relevant characteristics of older participants included in RCTs.
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2017-03-01 | PLoS ONE |