Epstein 2017.
Methods |
Study design: randomized trial Unit of allocation: provider Unit of analysis: patient Power calculation: done |
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Participants |
Care setting: ambulatory care, specialized care, USA Health professionals: 38; specialists; fully trained; male and female Patients: 265; non hematologic cancer; male and female |
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Interventions |
Multifaced intervention Patient MI + educational meeting
Quote: "(1) a 2‐session in‐office physician training (1.75 hours) using a brief video, feedback from standardized patients portraying roles of patients with advanced cancer, audio recorded study patient visits, and (2) a single 1‐hour patient and caregiver coaching session incorporating a question prompt list to help patients bring their most important concerns to their oncologist’s attention at an upcoming office visit, plus up to 3 follow‐up phone calls (Table 1; eTable 2 in Supplement 3). Trainers and coaches underwent 3‐day on‐site training. To promote patient centered communication about disease course, prognosis, treatment decisions and end‐of‐life care, physician and patient interventions focused on the same 4 key domains of patient centered communication." page 94 Usual care Quote from the abstract : "Control participants received no training." |
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Outcomes | Health Care Climate Questionnaire (HCCQ) (continuous) | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient information to make a judgement |
Allocation concealment (selection bias) | Low risk | Quote: "Only the study statisticians were aware of the random number sequences and treatment assignment, preserving blinding among transcriptionists, coders, and abstractors." Page 95 |
Blinding (performance bias and detection bias) Participant‐reported outcome | Unclear risk | Comment: insufficient information to permit judgement. |
Incomplete outcome data (attrition bias) Participant‐reported outcome | Unclear risk | Comment: missing outcome data were not specified. |
Selective reporting (reporting bias) | High risk | Comment: some relevant outcomes prespecified in the study protocol were not reported in the results: preferred role and actual role in decision making, PEACE (NCT01485627). |
Other bias | Low risk | |
Baseline measurement? Participant‐reported outcome | Unclear risk | Comment: insufficient information to permit judgement. |
Protection against contamination? | Unclear risk | Comment: professionals were allocated within a clinic or practice and it is possible that communication between intervention and control professionals could have occurred. |
Baseline characteristics patients | Low risk | Comment: see Table 1: no statistically significant differences between intervention and control for pre‐randomization or cluster‐RCT |
Baseline characteristics healthcare professionals | Low risk | COmment: eTable 1: no statistically significant differences between intervention and control for pre‐randomization or cluster‐RCT |