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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