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. 2012 Dec 12;2012(12):CD003267. doi: 10.1002/14651858.CD003267.pub2

Wilkinson 2008.

Methods Randomization procedure: Randomization was based on a random number sequence, using a computer randomized number generator, and stratified for the 10 course locations? Random allocation was performed by the statistician before the commencement of the study and placed in a sealed envelope, which was kept securely by the administrator within the central research department. On receipt of completed tapes 1 and 2, the nurses were randomized in the order that the tapes arrived at the researcher’s office. The research coordinator contacted the administrator by telephone to find out allocation
Informed consent obtained: Yes
Protection against contamination: contamination was possible but not addressed
Outcomes assessors blinded: The independent rater was blinded to which group tapes were from and whether it was the first, second or third taping.   
Intention to treat analysis: Primary analysis was on an intention to treat basis
Potential for unit of analysis error: Some measures were analysed by patient and simulated patients with randomisation by provider. However, the main outcomes are provider outcomes and ANCOVA for intervention groups before scores were fitted as covariates
Comments on study quality: Power was calculated with 90% power at the 5% significance level with 80 nurses per group. They had 85 & 87 in the groups. Raters kappa statistics for inter‐rater reliability were assessed for each item rated
Participants Profession: Nursing
Specialty: Registered Nurses in cancer and palliative care
Years experience: (RN at least 1 year). Mean time since qualified: Intervention 18.6 (9.4) Control 18.3 (10.6)
Clinical setting: Hospice, Community nursing service, other
Level of Care: Secondary
Country: UK (10 geographic locations)
Health problem/Type of Patient: Cancer Care both real and simulated patients
Interventions Aim of study (hypothesis): To evaluate the effectiveness of the 3‐day Wilkinson communication skills course in ability to change nurses’ communication skills
Following a 3‐day communication skills course, nurses’ communication skills would improve compared with nurses who did not take the course. Nurses attending the course would have a greater level of confidence in communicating with patients. Patients assessed by nurses following a course would have  lower levels of emotional distress, anxiety, and higher levels of satisfaction compared with those treated by nurses not attending the course
Content of intervention: The course included didactic teaching or communication and evidence base for communication skills training. Discussion of positive and negative communication behaviours. Learning strategies for handling difficult situations. Discussion of the emotional impact of communication
Interactive demonstration of the communication skills model. Role plays with actors to practice skills with feedback from participants and facilitators. Audio‐tapes of nurse‐patient interviews with feedback led by the facilitator. Consolidation materials were provided including CD‐ROM, handouts, reading list, and references      
Conceptual Focus:
  1. Focus in the consultation on the patient as a whole person who has individual preferences situated within social contexts. 

  2. Interactional skills

  3. Doctor patient relationship/Interviewing skills 

  4. Adult learner centred training


Number of providers receiving intervention: start 85/172 end 84/170
Number of patient receiving intervention: 321 tapes were completed and rated, 112 real patients. Intervention: 12 missing tape #3, 3 not usable = 50 patients.  Control: 62 patients (4 missing tape #3)
Fidelity/integrity of intervention: Audio‐taped interviews during the training sessions
Outcomes Primary Outcomes: 1. Communication Skills
Consultation process: Observed from audio tapes (coverage score at baseline; skills change score)
Satisfaction: Patient survey with care as measured by Patient Satisfaction With Communication survey by J. Ware
Health behaviours: NA
Health status: health status as measured General Health Questionnaire‐12 (GHQ‐12).
Notes Provider outcomes were also measured. Confidence with patients score 1. Baseline  2. Follow‐up 16 wks 3. Change from t1 to t2
Meta‐analysis
1) Consultation process continuous
1 patient/physician: no ICC needed
2) Satisfaction with Care, Continuous
1 patient/1 physician: no ICC
3) Health Status, Continuous
1 patient/1 physician: no ICC
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomization was based on a random number sequence, using a computer randomized number generator
Allocation concealment (selection bias) Low risk Random allocation was performed by the statistician before the commencement of the study and placed in a sealed envelope, which was kept securely by the administrator within the central research department
Blinding (performance bias and detection bias) 
 All outcomes Low risk The independent rater was blinded to which group tapes were from and whether it was the first, second or third taping
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Had minimal attrition rate: 1/85 (1.2) in intervention and 1/87 (1.1 in control). Intention to treat analysis was done with n = 85 and 87. 11% 0f nurses group had missing data. Those with missing data had lower baseline score but were otherwise similar to the res. However, because they were mostly in the control group effect would be to underestimate the effect of the positive intervention
Selective reporting (reporting bias) Low risk They reported on all outcomes measured
Other bias High risk Contamination was possible, but not addressed. Would have underestimated positive effects. Potential for unit of analysis error was addressed with ANCOVA in which intervention group scores were fitted as covariates. Baseline differences in primary outcome were adjusted for with pre‐post analysis