Table 1

Study outcome measures

Questionnaire at baseline (T0= directly after making a decision)Questionnaires at follow-up (T1=3 months, T2=6 months, T3=12 months after treatment)
PatientsPrimary outcomeDecisional conflict scale
Secondary outcomesSubjective and objective knowledge about prostate cancer (based on DQI knowledge, Karen Sepucha (Massachusetts General Hospital) and PCA 0915 of Carrie Levin)
Communication between patient and partner (study-specific questionnaire based on the study of Zeliadt)
Treatment preferences (study-specific questionnaire)
Experienced role in decision-making involvement (study-specific questionnaire based on the Deber-Kraetschmer Problem-Solving Decision-Making Scale)
Expectations of the treatment (SETS pretreatment)Outcome of the treatment (SETS post-treatment)
Quality of life (EORTC QLQ-C30 and PR25)Quality of life (EORTC QLQ-C30 and PR25)
The need for supportive care (SCNS SF-34 and prostate module)The need for supportive care (SCNS SF-34 and prostate module)
Decision regret (DRS)
Cost-evaluationQuality of life for the benefit of cost analysis (EQ-5D)Quality of life for the benefit of cost analysis (EQ-5D)
Direct medical and direct non-medical cost (TiC-P)Direct medical and direct non-medical cost (TiC-P)
Productivity costs (PRODISQ)Productivity costs (PRODISQ)
Additional questions patients in the intervention groupSatisfaction with interventionUse of the PDA (study-specific questionnaire)
Appreciation for the PDA (study-specific questionnaire)
Satisfaction with the use of the PDA (SCIP-B)
Preparation for decision making (Prep-DM)
Promoting and impeding factors using the PDA (study-specific questionnaire based on the study of Légaré)
PartnersSecondary outcomesCommunication between patient, partner and HCPs (study-specific questionnaire based on the study of Zeliadt)
Treatment preferences (study-specific questionnaire)
Experienced role in decision-making involvement (study-specific questionnaire based on the Deber-Kraetschmer Problem-Solving Decision-Making Scale)
Social contacts and support (AES)
Quality of life of partners (SF-12)Quality of life of partners (SF-12)
Effect of prostate cancer on the relationship of patient and partner (study-specific questionnaire based on the study of Zeliadt)Effect of prostate cancer on the relationship of patient and partner (study-specific questionnaire based on the study of Zeliadt)
Role as caregiver (CSI)Role as caregiver (CSI)
Additional questions partners in the intervention groupSatisfaction with interventionUse of the PDA (study-specific questionnaire)
Appreciation for the PDA (study-specific questionnaire)
Promoting and impeding factors using the PDA (study-specific questionnaire based on the study of Légaré)
Moderating factors patients and partnersStudy specific questionnaire including sociodemographic and clinical factors
Threatening Medical Situations Inventory (TMSI) questionnaire
HCPsDeterminants important for implementing an innovationMeasurement instrument for determinants of innovation: Identifying barriers and facilitators at the level of the innovation (the PDA itself), the user (HCP) and the organisation (hospital), only measured 3 months after using the PDA
  • AES, Active Engagement Scale; CSI, Caregiver Strain Index; DQI, Decision Quality Instrument; EORTC QLQ-C30, European Organisation for Research and Treatment of Cancer Quality of life questionnaire- Core questionnaire; EORTC QLQ-PR25, European Organisation for Research and Treatment of Cancer Quality of life questionnaire- Prostate cancer questionnaire; HCP, healthcare professional; PDA, Patient decision aids; Prep-DM, Preparation for Decision Making Scale; PRODISQ, PROductivity and DISease Questionnaire; SCIP-B, Satisfaction with Cancer Information Profile; SCNS, Supportive Care Needs Survey; SETS, Stanford Expectations of Treatment Scale; TiC-P, Trimbos and iMTA Questionnaire on Costs Associated with Psychiatric Illness.