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. 2018 Jul 19;2018(7):CD006732. doi: 10.1002/14651858.CD006732.pub4

Wolderslund 2017.

Methods Study design: randomized trial
Unit of allocation: patient
Unit of analysis: patient
Power calculation: done
Participants Care setting: ambulatory care, specialized care, Denmark
Health professionals: 49; various types; fully trained
Patients: 4349; pediatrics
Interventions Multifaceted intervention: Patient‐mediated intervention (question prompt list) + other (digital audio recording)
Single intervention: other (digital audio recording)
Usual care: Quote: "The study was designed as a three‐armed randomised controlled trial. One group of patients received standard care (Control), while the other two groups received either QPL in combination with a recording of their consultation (QPL‐DAR) or only the recording (DAR)." page 244
Outcomes Involvement in decision making (qualitative)
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Patients were randomly assigned on a weekly basis to one of the three groups using computer‐generated random numbers." page 244
Allocation concealment (selection bias) Unclear risk Comment: not enough information to make a judgement.
Blinding (performance bias and detection bias) 
 Participant‐reported outcome High risk Comment: Quote: "Neither the patients nor the health professionals were blinded to the randomisation group. Blinding would have required recordings of consultations in the control group without the patients having the possibility to replay the consultation, which we found unethical." page 248
Incomplete outcome data (attrition bias) 
 Participant‐reported outcome High risk Comment: very high rate of loss to follow‐up and proportion of losses to follow‐up were not well‐balanced between groups (flow chart).
Selective reporting (reporting bias) Unclear risk Comment: study protocol not available to permit judgement.
Other bias Low risk Comment: no evidence of other risk of biases.
Baseline measurement? 
 Participant‐reported outcome Unclear risk Comment: no information.
Protection against contamination? Unclear risk Comment: not enough information to make a decision.
Baseline characteristics patients Low risk Comment: characteristics between groups were similar at baseline (Table 1).
Baseline characteristics healthcare professionals Unclear risk Comment: no information about clinicians at baseline.

ACEPP: Assessing Communication about Evidence and Patient Preferences; ACP: Advanced care planning; ADDITION: Anglo‐Danish‐Dutch Study of Intensive Treatment;AHRQ: Agency for Healthcare Research and Quality; ASK: Ask Share Know; BRCA: Breast cancer susceptibility gene; CAPI: Computer Assisted Personal Interviewing; CCS: Canadian Cardiovascular Society; CGD: Chronic granulomatous disorder; CHC: Community health centre; CHD: Coronary heart disease; CHW: Community health worker; CME: Continuing medical education; COMRADE: Combined Outcome Measure for Risk Communication and Treatment Decision‐making Effectiveness; COPD: Chronic obstructive pulmonary disease; CPS: Control Preferences Scale; CRC: Colorectal cancer; CRS: Conventional risk score; CVD: Cardiovascular disease; DA: Decision aid; DAS‐O: Decision Analysis System for Oncology; DCS: Decision Control Scale; EHR: Electronic health record; EI: Enhanced intervention; FAPI: Fragebogen zur Arzt‐Patient‐Interaktion (quality of physician‐patient interaction scale); FCR: Family‐centered rounds; FRAX: WHO online calculator for discussing treatment options; GI: gastrointestinal; GP: General practitioner; GRS: Genetic risk score; HCCQ: Health Care Communication Questionnaire; HCP: Healthcare professional; HMO: Health maintenance organization; ICTRP: International Clinical Trials Registry Platform (WHO); ID: Identification; IPC: Interpersonal Processes of Care; MI: Mediated intervention; MS: Multiple sclerosis; NA: Not applicable; OPTION: Observing patient involvement; PAM: Patient Activation Measure; PANDA: Patient decision aid; PCI: Percutaneous coronary intervention; PCP: Primary care physician; PDA: Patient decision aid; PDM: Participatory Decision Making; PEF‐FB‐9: Partizipative Entscheidungsfindung‐Fragebogen‐9; PP: Patient participation; PROM: Patient‐reported outcome measure; PROMIS: Patient‐Reported Outcomes Measurement Information System; QPL: Question prompt list; QPS: Question prompt sheets;QQPPI: Questionnaire on the Quality of Physician‐Patient Interaction; RA: Rheumatoid arthritis; SAS: Statistical Analysis System; SDM‐Q9: Shared Decision Making Questionnaire (9‐item); SDM: Shared decision making; SDMI: Shared decision making intervention; SES: Socioeconomic status; TAS: Treatment Alliance Scale; TTE: Time to event; TTO: Time trade‐off; UC: Usual care; VOICE: Valuing Opinions, Individual Communication and Experience.