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. 2012 Jul 11;2012(7):CD007672. doi: 10.1002/14651858.CD007672.pub2

Liu 2006.

Methods CCT; Unit of allocation: Patient; Stratified by: Day of visit to the hospital
Participants Women newly diagnosed as having breast cancer and scheduled to have a breast operation within a few days.
Setting / country: Two urban teaching hospitals in Taipei /Taiwan
Type of cancer: Breast
Phase of care: Pre‐treatment, treatment, discharge, surveillance
Sample size at randomisation: 61
Interventions Education and continuing supportive care (CSC): A follow‐up care plan was implemented. Through it, patients were sequentially provided with psychological support and health education on care of the breast cancer by a trained registered nurse. With this program, a senior nurse served as a coordinator to organise all the important information and to provide the proper teaching time scheduler. In this study, a senior nurse not only provided teaching and emotional support to both the subjects and their primary caregivers but also followed up the outcome step‐by‐step. The main contents of the continuing supportive care (CSC) were comprehensive, including provision of information, emotional and psychological support, appropriate referral, and continuous follow‐up (see the Appendix published with the article for more details).
Control: Routine care provided by nurses from different units of hospital. Nurses would decide how and when to teach the subjects based on their own experience, and educational contents were not organised. Emotional support and education provided by nurses were not continuous but occasional throughout the whole disease progress.
Outcomes Patient: Social support, uncertainty  
Notes Length of follow‐up: 3 months
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Quote: "We used a quasi‐experimental research design in which study participants were not randomly assigned to the comparison groups. (...) Instead, we referred patients who came to the hospital on the same day to the same group."
Comment: This trial used a quasi‐experimental design.
Allocation concealment (selection bias) High risk See quote first item.
Blinding (performance bias and detection bias) 
 All outcomes High risk The outcomes were evaluated with self‐administered questionnaires, and patients were not blinded, so assessment could not possibly be blinded.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Quote: "Five patients failed to complete the follow‐up over the 3‐month period: 4 in the experimental group and 1 in the control group. Reasons for dropping out included emigration soon after surgery was completed (n = 1) and inability to respond on time at 3 months after surgery (n = 4)." 
Comment: Reasons for attrition in each group are not described. No imputation seems to have been used.
Selective reporting (reporting bias) Low risk All outcomes described in Methods are reported in Results.
Other bias Low risk  No evidence of any other bias.
Baseline outcomes similar? Low risk Table 2 shows that patients had similar outcomes at baseline.
Baseline characteristics similar? Low risk Table 1 shows that patients had similar characteristics at baseline.
Protected against contamination? Low risk Quote: "We decided not to perform random assignment of individual patients into groups for comparison to avoid a possible contamination bias that could be caused by 2 or more patients visiting the clinic on the same day likely discovering the contents of the nursing care received by the other person, so that those assigned to the control group would get information from their experiment counterparts on a later day."