title: VALFORTA: a randomised trial to validate the FORTA (Fit fOR The Aged) classification.
abstract: METHODS
  to further validate the FORTA (Fit fOR The Aged) concept, a bicentric randomised, controlled trial was run in two geriatric clinics.
  
  
  METHODS
  patients (≥65 years, ≥3 drugs or ≥60 years, ≥6 drugs) with three relevant diseases and hospitalisation for ≥5 days were randomised. In the intervention, but not the control group, a FORTA team instructed ward physicians on FORTA. FORTA is the first positive/negative listing approach labelling medications used to treat chronic illnesses in older patients from A (indispensable), B (beneficial), C (questionable) to D (avoid). The primary end point was the FORTA score: sum of medication errors classified as over-, under- and mistreatment. Consecutive patients were randomised to the intervention and control ward; outcome assessment was blinded.
  
  
  RESULTS
  four hundred and nine patients (age 81.5 years, 64% female, hospitalisation 17.4 days) were included. The primary end point was significantly (P < 0.0001) more reduced in the intervention versus control groups (2.7 ± 2.25 versus 1 ± 1.8, mean ± SD, intergroup comparison of admission/discharge differences). Over- and under-treatment scores and use of A (increase) and D (decrease) drugs were significantly improved (P < 0.01). The total number of adverse drug reactions (ADRs) was significantly reduced by FORTA (P < 0.05, number needed to treat is 5). Activities of daily living and renal failure improved significantly (P < 0.05). Blood pressure remained constant in the intervention, but decreased significantly in the control group.
  
  
  CONCLUSIONS
  applying FORTA to hospitalised geriatric patients leads to improvement of medication quality and may improve secondary clinical end points (e.g. ADRs). The concept is amenable to successful communication and implementation. Registration (DRKS-ID): DRKS00000531.
  
  
  BACKGROUND
  DFG-German Research Foundation (WE 1184/15-1).
authors.affiliation: Clinical Pharmacology, University of Heidelberg, Mannheim 68169, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Wehling
authors.affiliation: IV. Medical Clinic, Geriatrics, University Hospital Mannheim, Heidelberg University, Mannheim, Germany.
authors.forename: Heinrich
authors.initials: H
authors.lastname: Burkhardt
authors.affiliation: Clinical Pharmacology, University of Heidelberg, Mannheim 68169, Germany.
authors.forename: Alexandra
authors.initials: A
authors.lastname: Kuhn-Thiel
authors.affiliation: Clinical Pharmacology, University of Heidelberg, Mannheim 68169, Germany.
authors.forename: Farhad
authors.initials: F
authors.lastname: Pazan
authors.affiliation: Clinical Pharmacology, University of Heidelberg, Mannheim 68169, Germany.
authors.forename: Christina
authors.initials: C
authors.lastname: Throm
authors.affiliation: Department of Medical Statistics, Biomathematics and Information Processing, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.
authors.forename: Christel
authors.initials: C
authors.lastname: Weiss
authors.affiliation: Essen-Mitte Hospital, Knappschafts Hospital, Teaching Hospital at the University of Duisburg in Essen, Am Deimelsberg 34a, 45276 Essen, Germany and Faculty of Health, University of Witten-Herdecke, Witten, Germany.
authors.forename: Helmut
authors.initials: H
authors.lastname: Frohnhofen
mesh_terms: D000203:Activities of Daily Living; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000375:Aging; D001794:Blood Pressure; D015897:Comorbidity; D064420:Drug-Related Side Effects and Adverse Reactions / Q000517:prevention & control*; D005260:Female; D015577:Geriatric Assessment / Q000379:methods*; D005858:Germany; D006304:Health Status; D006305:Health Status Indicators; D006801:Humans; D057970:Inappropriate Prescribing / Q000517:prevention & control; D008297:Male; D008508:Medication Errors / Q000517:prevention & control*; D054539:Medication Therapy Management / Q000592:standards; D008875:Middle Aged; D010343:Patient Admission; D019338:Polypharmacy; D058996:Quality Improvement; D019984:Quality Indicators, Health Care; D051437:Renal Insufficiency / Q000175:diagnosis / Q000628:therapy; D012307:Risk Factors
keywords: FORTA score; activities of daily living; clinical trial; geriatric pharmacotherapy; older people; polypharmacy