Harmsen 2005.

Methods	Randomization procedure: Randomisation was not described Informed consent obtained: Insufficient data Protection against contamination: Adequate Outcomes assessors blinded: Adequate. "Interviewers, experts, and research assistants who conducted preliminary data processing were blinded for intervention assignment" Patients were also blinded to group assignment of their providers Intention to treat analysis: Not done Potential for unit of analysis error: Yes, acknowledged and adjusted for. Sample size was calculated "taking the multilevel design into account and assuming an ICC of 0.2" In analysis, "differences between the two patient groups were tested by means of regression analysis with adjustment for baseline fraction, weighing cases (physicians) wit total number of patients seen at baseline plus at measurement concerned" Used multilevel multiple regression techniques Comments on study quality: Underpowered study, no account for multiple testing, different patients were used at each measurement point, the changes reported are likely due to chance with a double intervention.  It is not clear how much impact to ascribe to each. Low rates of doctor recruitment preclude generalisability. The study did not address the hypothesis of improving equality of care between western and non‐western patients just reflect on mutual understanding
Participants	Profession: Medicine Specialty: General Practice Years experience: Over 5 years in current practice Clinical setting: Primary care practices of all types Level of Care: Primary Country: Holland Health problem/Type of patient: Primary care for a variety of unspecified problems. Median age 30‐49 years. Female 62.8%. Not proficient in Dutch 9.5%
Interventions	Aim of study (hypothesis): To evaluate the effects of dual education intervention on intercultural communication given to both doctors and patients on intercultural communication.  To reduce differences in mutual understanding, primary outcome, and perception of quality of care in patients with different native origins. The hypothesis was that this will decrease inequalities in care between western and non‐western patients Content of intervention: Training on intercultural communication based on 3‐step method.  Doctors reflected on their own cultural norms, views, and communication style.  To improve sensitivity and knowledge about cultural differences especially from non‐western countries.  Trained doctors in self‐selected strategies to solve gaps in views and culturally determined communication style.  Two weeks later in the final session additional problems and advice was discussed.  Patients received a co‐intervention of viewing a 12 minute videotape in the waiting room immediately before consultation; available in Dutch, Moroccan‐Arabic, Moroccan‐Berber, and Turkish.  The main message of the video was to communicate directly and express misunderstanding or disagreement Conceptual Focus: None checked (0/7).  Skills were taught but idiosyncratic and self‐selected Duration and timing: For doctors, 3 sessions over 2.5 days spread over 2 weeks. For patients, one 12 minute session Number of providers receiving intervention: 19/38 (start) 19/36 (end) Number of patient receiving intervention: baseline group 1 = 175, one month group 2 = 161, 6 month group 3 = 151 Fidelity/integrity of intervention: Not given
Outcomes	Primary outcomes:  Mutual understanding Consultation process: Mutual Understanding (Patient and doctor report) Satisfaction: Satisfaction with consultation by 3 item survey dichotomized to yes/no Health behaviours: NA Health status:  NA
Notes	References included in review of this article:  None Meta‐analysis: Satisfaction, Dichotomous (patient satisfaction; assume ICC of .2 per article) Unadjusted sample sizes: intervention: 151 patients/18 physicians control: 151 patients/17 doctors ICC: .2 DEFF: 1+ICCx(cluster size‐1)=1+0.2[(151+151)/(18+17)‐1]=2.526 Adjusted sample sizes: intervention: n=151/2.526=60 control: n=151/2.526=60
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomisation was not described
Allocation concealment (selection bias)	Unclear risk	Did not indicate whether randomisation was concealed
Blinding (performance bias and detection bias) All outcomes	Low risk	"Interviewers, experts, and research assistants who conducted preliminary data processing were blinded for intervention assignment" Patients were also blinded to group assignment of their providers
Incomplete outcome data (attrition bias) All outcomes	High risk	351/717 (43.9%), 333/848 (39.2%), and 302/842 (35.8%) patients completed interview in first, second and third wave respectively. Did not use intention to treat analysis
Selective reporting (reporting bias)	Low risk	Main outcome parameter was mutual understanding. Secondary outcomes were patient satisfaction with consultation and feeling that physician had been considerate. Quality of care was measured with Quote‐Mi. They reported on all measures in results
Other bias	High risk	Baseline measurements were collected and adjusted for in multiple regression. Unit of analysis error was acknowledged and adjusted for. Contamination was possible but not addressed ‐ would have underestimated effect