Antonicelli 2008.

Methods	Randomized controlled trial
Participants	The study location was the Italian National Research Centre on Aging, Ancona, Italy 29 participants were randomized to the intervention group and 28 participants were randomized to the control group The inclusion criteria were patients with congestive heart failure of NYHA class II‐IV The exclusion criteria were lack of co‐operation and/or of reliable family assistance at home, severe dementia or debilitating psychiatric disorders, inability to access a home telephone line, end‐stage heart failure requiring regular inotropic drug infusions, cachexia, chronic renal failure, requiring dialysis treatment, and unstable angina
Interventions	Intervention: HOME TELEMONITORING Patients were in a 12‐month follow‐up period. Patients (or one of their relatives) were contacted by telephone at least once a week by the chronic heart failure (CHF) team to obtain information on symptoms and adherence to prescribed treatment, as well as blood pressure, heart rate, bodyweight, and 24‐hour urine output data for the previous day. A weekly ECG transmission was also required. Evaluation of these parameters was followed by reassessment of the therapeutic regimen and modification whenever needed. In addition, clinic visits were arranged as required on the basis of the data provided by telemonitoring or telephone interviews. Decisions on hospital re‐admission during follow‐up in both groups were made after consultation with a CHF team member Control: STANDARD CARE Patients (or one of their relatives) in the control group were contacted monthly for 12 months of follow‐up by telephone to obtain data on new hospital admissions, cardiovascular complications, and death. These patients were also routinely seen in the CHF outpatient clinic every 4 months, with additional visits being arranged whenever changes in clinical status made this necessary
Outcomes	The measures of adherence were in the telemonitoring group, patients (or one of their relatives) were contacted by telephone at least once a week by the CHF team to obtain information on adherence to prescribed treatment. It is not clear how adherence was measured in the control group The patient outcomes were new hospital admissions, cardiovascular complications and death, and symptoms, which were assessed by telephone contact at least once a week by the CHF team with patients (or one of their relatives). These calls also assessed blood pressure, heart rate, bodyweight, and 24‐hour urine output data for the previous day. A weekly ECG transmission was also required. The primary composite endpoint was the combined rate of mortality and re‐admission to hospital because of CHF. The secondary endpoints were rates of mortality and re‐hospitalization considered separately over the follow‐up period.
Notes	―
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Author's note: All randomization steps were done by the statistician
Allocation concealment (selection bias)	Low risk	Author's note: All randomization steps were done by the statistician. All envelopes were concealed; there was no possibility for investigator bias
Selective reporting (reporting bias)	Low risk	Author note: We followed the protocol from the previous study, published at Journal of Telemedicine and Telecare 2008;14:300‐5. All outcomes were reported
Other bias	High risk	Limitations noted by author: small sample size and short follow‐up period
Blinding of outcome assessment (detection bias) Adherence measure	Unclear risk	(PRIMARY) TELEPHONE SURVEY ‐ No information about blinding is provided
Blinding of outcome assessment (detection bias) Patient outcome	Low risk	(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Author note ‐ Yes, outcome assessors were blind
Blinding of participants (performance bias) Adherence measure	High risk	(PRIMARY) TELEPHONE SURVEY ‐ No information about blinding in the manuscript, but likely that patients were not blinded because it is impossible to blind participants to the study group
Blinding of participants (performance bias) Patient outcome	Unclear risk	(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Author note ‐ Patients were blind to the intervention
Blinding of personnel (performance bias) Adherence measure	Unclear risk	(PRIMARY) TELEPHONE SURVEY ‐ No mention of blinding study staff or note on role in study; unclear how this would impact the outcome
Blinding of personnel (performance bias) Patient outcome	Low risk	(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Author note ‐ Yes, study personnel were blind
Incomplete outcome data (attrition bias) Adherence measure	Unclear risk	(PRIMARY) TELEPHONE SURVEY ‐ No mention of dropouts; thus may have 100% follow‐up but not sure
Incomplete outcome data (attrition bias) Patient outcome	Unclear risk	(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ No mention of dropouts; thus assume 100% follow‐up but this is unclear