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

Gould 2009.

Methods Randomized controlled trial
Participants The study location was not specified
64 participants were randomized to the intervention group and 65 participants were randomized to the control group
The inclusion criteria were adult male and female patients between the ages of 30 and 80 years treated for an acute cardiac event with percutaneous coronary intervention (PCI) and discharged from a hospital setting within 72 hours of the procedure
The exclusion criteria were if the patients were not accessible by telephone, had conditions that may impair telephone communication, or were enrolled in clinical trials or other research activity requiring telephone follow‐up
Interventions Intervention: DISCHARGE NURSING INTERVENTION (DNI)
 The discharge nursing intervention consisted of written discharge materials and telephone follow‐up by an expert cardiovascular nurse. Expert nurses were defined as those having advanced education and clinical expertise in the care and management of this population. Delivery of the intervention was time‐sensitive. The intervention was offered at discharge and continued within 24 hours of discharge. DNI group received a packet containing group instructions, medication review materials, a medication pocket card, suggested Internet sites, copies of the interview tools, and the Revised Illness Perception Questionnaire (IPQ‐R) instrument
Control: USUAL CARE
 Control group patients received routine discharge materials and usual care. Subjects in the control group received an envelope containing group instructions, copies of interview tools, and the IPQ‐R
Outcomes The measures of adherence were the Self‐Reported Medication Taking Scale and the Machtinger and Bansberg visual analog scale. They were given the patients at discharge, with responses collected 1 to 3 days later via telephone
The patient outcome was urgent care visits. This was measured via questions in a telephone interview 3 days after hospital discharge. Patients were asked if they had placed an urgent call to their physician or to the hospital or visited an ER since discharge
Notes The authors got consent from 154 patients but only 129 were included in the analysis. It is not clear whether the 154 patients were randomized and then they dropped out or whether they dropped out prior to randomization
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information to judge. (pg 120) Following consent, patients were randomly assigned into 2 groups: control and experimental, determined by selection of sealed envelopes containing group assignment and study materials
Allocation concealment (selection bias) Low risk Additional info provided by author: the PI completed the consent process and delivered the intervention. Allocation concealment was done as patients were assigned to groups using a sealed envelope technique. The envelopes were identical visually and physically. Envelopes were prepared by the primary investigator but were shuffled and placed in a container by 2 adults without the PI present. The PI had no knowledge of group assignment until the patient opened the envelope. At that point both patient and PI became aware of group assignment. The staff caring for the patient was not aware of group assignment
Selective reporting (reporting bias) Unclear risk No protocol available
Other bias Unclear risk None noted but unclear
Blinding of outcome assessment (detection bias) 
 Adherence measure Low risk (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Additional info provided by author: the PI completed the consent process and delivered the intervention. Allocation concealment was done as patients were assigned to groups using a sealed envelope technique. The envelopes were identical visually and physically. Envelopes were prepared by the primary investigator but were shuffled and placed in a container by 2 adults without the PI present. The PI had no knowledge of group assignment until the patient opened the envelope. At that point both patient and PI became aware of group assignment. The staff caring for the patient was not aware of group assignment
Blinding of outcome assessment (detection bias) 
 Patient outcome High risk (PRIMARY) USE OF URGENT CARE ‐ Author's note: the staff in the cardiovascular department, caring for the patients, were not aware of group assignment. The PI was aware of patient assignment during the interviews and patients were aware of assignment during interview
Blinding of participants (performance bias) 
 Adherence measure High risk (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Author's note: the PI and patients were blinded only during the enrollment stage. Following consent, both patients and PI became aware of group assignment
Blinding of participants (performance bias) 
 Patient outcome High risk (PRIMARY) USE OF URGENT CARE ‐ Author info: patients were aware of assignment during interviews
Blinding of personnel (performance bias) 
 Adherence measure High risk (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Author's note: the PI and patients were blinded only during the enrollment stage. Following consent, both patients and PI became aware of group assignment
Blinding of personnel (performance bias) 
 Patient outcome High risk (PRIMARY) USE OF URGENT CARE ‐ Author's note: the PI was aware of patient assignment during the interviews
Incomplete outcome data (attrition bias) 
 Adherence measure Unclear risk (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ No information given about the group membership of the dropouts, or if they were disproportionate in one group over the other
Incomplete outcome data (attrition bias) 
 Patient outcome Low risk (PRIMARY) USE OF URGENT CARE ‐ There is a low risk of bias; there seems to be no missing information. Refer to Table 3, 4 and 5: there seems to be no data missing for use of urgent care data, and patient satisfaction. 1 participant's data are missing from the control group for illness perception (because there are only 64/65)