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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