Costa 2008.
Methods | Randomized controlled trial | |
Participants | The study location was a tertiary outpatient clinic in Brazil 78 participants were randomized to the intervention group and 75 participants were randomized to the control group The inclusion criterion was hospitalization because of first acute myocardial infarction |
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Interventions | Intervention: TRANSDISCIPLINARY APPROACH
The transdisciplinary intervention consisted of clinical follow‐up, smoking cessation assistance, dietary advice and lifestyle modification advice. The intervention was delivered by a team consisting of an endocrinologist, a cardiologist, a nurse, and a dietician. There were 2 follow‐up assessments ‐ at 60 to 90 days after MI and 120 to 180 days after MI. In diabetic patients, capillary glycemia was measured (Advantage reagent strips, Roche, Indianapolis, IN, USA), lower limbs were examined, and adherence to prescribed oral antidiabetic agents and insulin was reviewed. Those patients who were still smoking were advised to stop smoking by the nurse and also by the cardiologist. No oral medication was prescribed in this regard since these drugs are not routinely provided by the Public Health System in Brazil. After the above‐described procedures, the dietitian evaluated body weight and performed a nutritional review. This review was followed by reinforcement of healthy nutritional habits, which included information on the characteristics and amount of healthy meals according to each case and also lifestyle modification reinforcement. The management plan was formulated as an individualized therapeutic alliance among the patient and family, the physician, and other members of the healthcare team. Finally, patients were evaluated by the cardiologist, who completed the visit with the specific medical history, physical examination and specific complementary tests. Drug prescription by the cardiologist followed the AHA guidelines for both groups (statins, antiplatelet therapy, beta‐blockers, and angiotensin‐converting enzyme inhibitors). Diabetic patients were evaluated by an endocrinologist. Drug prescription by the endocrinologist followed the American Diabetes Association (ADA) guidelines for both groups Control: CONVENTIONAL CARE Conventional care group received regular care. Before discharge, they were visited by a dietitian who prescribed a post‐discharge diet plan after nutritional evaluation. Then they were referred to the conventional outpatient clinic for heart care, where the patients were seen only by the appointed cardiologist. Cardiologists kept a routine schedule with the patients and were seen for no more than 15 minutes. Then these participants were asked to be present at the clinic 180 days after AMI to perform a clinical examination and to obtain blood samples |
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Outcomes | The measures of adherence were a questionnaire administered to the patient/family members twice during the follow‐up period, 60 to 90 days after MI and 120 to 180 days after MI The patient outcomes were clinical improvement, which was evaluated by means of a constructed index comprising lowering of body weight (> 5% from baseline), lowering of blood pressure levels (< 135/85 mm Hg), cessation of smoking (yes or no), increased physical activity and compliance with medication. Reduction in smoking was not counted as cessation. Blood pressure was measured with the patient seated for 5 minutes and using an aneroid or mercury sphygmomanometer, periodically calibrated according to the recommendations of the VII Joint National Committee (JNC). Body weight and height were measured on a manual balance (Filizzola, SP, Brazil), with a maximum capacity for a 150 kg load and 1.90 m height. Compliance with medication was evaluated by asking questions directly to the patient/family members. For each item with a positive change, 1 point value was assigned. A final sum of greater than or equal to 4 points was considered very good. In addition blood samples were collected at the outpatient clinic for the measurement of total plasma cholesterol and triglycerides. All the measurements were performed during the 2 follow‐up visits, first one between days 60 to 90 post MI and the second 120 to 180 days post MI |
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Notes | ― | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | (pg 490) "This randomized clinical trial contained two groups, control and intervention, which were distributed randomly in blocks of 20 by randomization software (Random, PEPI 4.0)." |
Allocation concealment (selection bias) | Unclear risk | Insufficient information was provided. "This randomized clinical trial contained two groups, control and intervention, which were distributed randomly in blocks of 20 by randomization software (Random, PEPI 4.0)." (pg 490) |
Selective reporting (reporting bias) | High risk | Fasting plasma glucose was measured using the automated enzymatic method. (pg 491) This outcome is not reported anywhere |
Other bias | High risk | Self reporting bias. Large amount of data are missing. E.g. for primary outcome 48 and 51 missing from CC and TC groups |
Blinding of outcome assessment (detection bias) Adherence measure | High risk | (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ The patients and health professionals involved in outpatient treatment were not blinded as to their allocation (pg 490) |
Blinding of outcome assessment (detection bias) Patient outcome | High risk | (PRIMARY) CLINICAL EXAMINATION ‐ The patients and health professionals involved in outpatient treatment were not blinded as to their allocation (pg 490) |
Blinding of participants (performance bias) Adherence measure | High risk | (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Participants were aware of the intervention due to its nature |
Blinding of participants (performance bias) Patient outcome | High risk | (PRIMARY) CLINICAL EXAMINATION ‐ The patients and health professionals involved in outpatient treatment were not blinded as to their allocation |
Blinding of personnel (performance bias) Adherence measure | Unclear risk | (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ The patients and health professionals involved in outpatient treatment were not blinded as to their allocation (pg 490) |
Blinding of personnel (performance bias) Patient outcome | High risk | (PRIMARY) CLINICAL EXAMINATION ‐ The patients and health professionals involved in outpatient treatment were not blinded as to their allocation (pg 490) |
Incomplete outcome data (attrition bias) Adherence measure | Unclear risk | (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ ITT analysis used, missing data not balanced between groups, reasons unknown. Not sufficient information to make a judgment |
Incomplete outcome data (attrition bias) Patient outcome | Unclear risk | (PRIMARY) CLINICAL EXAMINATION ‐ Refer to Table 2: there are 3 dead in CC group and 1 from the TC group. Refer to Table 3. The reasons for missing information are not available |