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. 2014 Nov 20;2014(11):CD000011. doi: 10.1002/14651858.CD000011.pub4

Jiang 2007.

Methods Randomized controlled trial
Participants The study location was Chengdu, Sichuan Province, China
83 participants were randomized to the intervention group and 84 participants were randomized to the control group
The inclusion criteria were first hospitalization with either angina pectoris or myocardial infarction, willing to participate in this study, able to speak, read and write Chinese, living at home with family after hospital discharge, living in Chengdu and available for telephone follow‐up, with fasting blood sample taken for lipid test within 24 hours of hospitalization
The exclusion criteria were planning for surgical treatment, pre‐existing mobility problems, hypothyroidism or nephrotic syndrome, diagnosed psychosis or currently undergoing antipsychosis treatment or with terminal illness
Interventions Intervention: CARDIAC REHABILITATION PROGRAM
 Patients in the intervention group received a 12‐week, hospital‐initiated, home‐based, multifaceted cardiac rehabilitation intervention led by a nurse. Phase I of the intervention involved in‐hospital individual and family education about CHD and self management principles, medication management, angina prevention and management, physical exercise, dietary management, smoking cessation, and family support. All sessions employed principles of adult learning and were short to facilitate time for discussion. All participants received a self help practical workbook. In Phase II of the intervention provided home‐based supervision, coaching and support by a experienced cardiac nurse over 12 weeks using home visits and telephone calls that included goal setting, practice, monitoring, problem solving and reinforcement, with iteration of this process to ensure the achievement of mutually set behavioral goals on a daily basis and used a log record for goal‐directed self reporting, self monitoring and self reinforcement of daily rehabilitative behaviors and mobilization of the family to join the behavioral change and provide appropriate support
Control: ROUTINE CARE
 Control patients received conventional care and were not offered any additional interventions
Outcomes The measures of adherence were self reported drug compliance scale was selected to assess the patients' level of medication adherence. The measure is a 5‐point Likert scale ranging from 1 (totally drug refusal) to 5 (about 100% drug compliance). The assessment span was 1 week
The patient outcomes were body weight examined using a balance scale, with patients in light clothing, shoes removed, and after urination. Arterial BP on the right arm in a sitting position was measured by the auscultatory method. Lipid testing was carried out in the Blood Biochemistry Laboratory of the 2 hospitals. All plasma samples were taken before 9 am. Subjects were instructed to take nothing orally except water and medication for 12 hours before the test. Measurements were made by a trained research assistant at baseline, 3, and 6 months
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk (pg 2) The research design used in this study is a 2‐group randomized intervention design, involving randomized assignment of subjects into an intervention group and a control group according to a computer‐generalized random table
Allocation concealment (selection bias) Unclear risk Allocation concealment not described. Insufficient information to permit judgment of 'Low risk' or 'High risk'
Selective reporting (reporting bias) Unclear risk None detected but protocol not available
Other bias Unclear risk They do not report the details of standard/routine care, so we are unsure of how different the intervention is from what the control group received. They also do not report the intensity (frequency and duration) of each contact by the study registered nurse (RN) with the patient
Blinding of outcome assessment (detection bias) 
 Adherence measure Low risk (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ (pg 1888) "Before proceeding to data collection in the pilot study, two research assistants underwent the following training...They were blinded to patient group assignment. One was responsible for the face‐to‐face interview according to the questionnaire. The other was responsible for conducting the health assessment for body weight and BP and for taking blood samples for lipid testing."
Blinding of outcome assessment (detection bias) 
 Patient outcome Low risk (PRIMARY) SERUM LIPIDS ‐ Objective measure
Blinding of participants (performance bias) 
 Adherence measure High risk (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Patients are likely to know to which group they are assigned. Subjective measure
Blinding of participants (performance bias) 
 Patient outcome Low risk (PRIMARY) SERUM LIPIDS ‐ Objective measure
Blinding of personnel (performance bias) 
 Adherence measure Unclear risk (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Insufficient information to permit judgment of 'Low risk' or 'High risk'
Blinding of personnel (performance bias) 
 Patient outcome Low risk (PRIMARY) SERUM LIPIDS ‐ Objective measure
Incomplete outcome data (attrition bias) 
 Adherence measure Unclear risk (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ During the course of this study, 4 subjects in the intervention group and 12 subjects in the control group dropped out at 3 months; 10 (5 in the intervention group and 5 in the control group) dropped out at 6 months. A total of 151 and 141 patients completed the study at 3 and 6 months, respectively. This means of 167 participants, 83 in intervention, 75 completed data at 6 months, while of 84 in control group, 67 completed data at 6 months. They never suggest how this was accounted for in analysis. Randomized 167 participants
Incomplete outcome data (attrition bias) 
 Patient outcome Unclear risk (PRIMARY) SERUM LIPIDS ‐ 9 lost in the intervention groups and 17 in control; thus an imbalance in dropouts; but unclear in terms of bias