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Table 5 Data collection; content of case report form (CRF)

From: Preventing hospital admissions by reviewing medication (PHARM) in primary care: design of the cluster randomised, controlled, multi-centre PHARM-study

Part Data content
Patient data • patient ID* • age*§ • gender*§ • pharmacist*§ • GP*§ • weight#/+ • lengths#/+ • diet+ • alcohol consumption+ • smoking habits+ • cognition$ • abilities/disabilities+ • daily activities+ • former education\language+ • religion+ • home situation+ • home help+ • carer+ • medication aids+ • other relevant information (free text) +
Medical data • acute medical conditions (menu, coded with ICPC-code[31])# • chronic medical conditions (menu, coded with ICPC-code[31])* # • current complaints or symptoms (menu, coded with ICPC-code[31]) # • significant past medical conditions or procedures# • other relevant health information (free text) #
Clinical data • laboratory values# • blood pressure# • temperature# • weight# • other relevant measured clinical data# available clinical data is collected from 12 months before inclusion till the end of the inclusion period.#
Medication data full drug history: all dispensed drugs from 12 months before inclusion till the end of the inclusion period§, containing information on: • chemical substance (menu, coded with ATC-code[25]) § • dispensed product (extracted from pharmacy database)* § • dispensed amount (extracted from pharmacy database)* § • dispensing date (extracted from pharmacy database)* § • prescribed dose (extracted from pharmacy database)* § • over the counter (OTC) drugs§, + • vitamins, dietary or nutritional supplements§, + • other health products§, + • medical devices§, + • drug allergies§, + • intolerabilities or adverse drug events§, +
Study outcomes • hospital admissions (discharge letter as appendix)# • date of each admissions# • reason for eacht admission# • quality of life; EQ5D score (at t = 0* and t = 12 months)+ • visual analogue scale score(at t = 0* and t = 12 months) + • adverse drug events (ADE) with symptom, related drug and timing information (at t = 12 months) +, # • severity of the ADE+, #
Pharmaceutical care plan$ • DTPs (according to the Subjective-Objective-Assessment-Plan (SOAP) notes[29]) • therapy goals • priorities • interventions • clinician who is executing the action • date of action • date of evaluation of the action
  1. * obligatory; $ for intervention patients only
  2. # Obtained from medical record
  3. § Obtained from medication record
  4. + Obtained from the patient during pharmaceutical anamnesis or questionnaire