No favourable effect on mortality was observed with STS HM .
Similar reductions were observed in all-cause hospitalisations for TM interventions , whereas STS interventions had no major effect .
STS HM was dominated by usual care .
Similar results were observed in scenario analyses performed using higher costs of usual care , higher costs of STS HH and lower costs of TM during office hours .
As a result , the economic model developed scenarios for different RM classifications and their costs were estimated using bottom-up costing methods .
Despite wide variation in usual care and RM strategies , cost-effectiveness analyses suggest that TM during office hours was an optimal strategy ( in most costing scenarios ) .
However , clarity was lacking among descriptions of the components of RM packages and usual care and there was a lack of robust estimation of costs .
BACKGROUND Remote monitoring ( RM ) strategies have the potential to deliver specialised care and management to patients with heart failure ( HF ) .
OBJECTIVE To determine the clinical effectiveness and cost-effectiveness of home telemonitoring ( TM ) or structured telephone support ( STS ) strategies compared with usual care for adult patients who have been recently discharged ( within 28 days ) from acute care after a recent exacerbation of HF .
The review included r and omised controlled trials ( RCTs ) or observational cohort studies with a contemporaneous control group that included the following RM interventions : ( 1 ) TM ( including cardiovascular implanted monitoring devices ) with medical support provided during office hours or 24/7 ; ( 2 ) STS programmes delivered by human-to-human contact ( HH ) or human-to-machine interface ( HM ) .
Rationale and design of a prospective trial to assess the sensitivity and positive predictive value of implantable intrathoracic impedance monitoring in the prediction of heart failure hospitalizations: the SENSE-HF study.
BACKGROUND Intrathoracic impedance monitoring is a new diagnostic tool for patients with heart failure that may aid early identification of decompensation and pulmonary congestion . METHODS AND RESULTS The Sensitivity of the InSync Sentry feature for the Prediction of Heart Failure ( ie , SENSE-HF ) trial is a prospect i ve multicenter international study design ed to evaluate the sensitivity and positive predictive value ( PPV ) of the intrathoracic impedance diagnostic tool , OptiVol , present in Medtronic implantable devices . A total of 500 patients will be enrolled in the trial , with follow-up for up to 24 months . The study has 3 phases . Phase I is double-blind , and evaluates retrospectively the sensitivity and PPV of the intrathoracic impedance data for the prediction of hospitalization with the signs and /or symptoms of pulmonary congestion . At 6 months , the patient enters Phase II , which evaluates the clinical utility of the nominal " alarm " threshold value for identification of episodes of decompensation . The patient enters the final phase ( Phase III ) after an episode of decompensation correctly identified by the Fluid Trend data ( " true " positive alarm ) , with data collection on how physicians use the Fluid Trend data to influence management . An end point committee adjudicates health care utilizations events ( hospitalizations and doctor visits ) for their association with signs and /or symptoms of pulmonary congestion . CONCLUSIONS The study completed recruitment during 2008
No favourable effect on mortality was observed with STS HM .
Similar reductions were observed in all-cause hospitalisations for TM interventions , whereas STS interventions had no major effect .
STS HM was dominated by usual care .
Similar results were observed in scenario analyses performed using higher costs of usual care , higher costs of STS HH and lower costs of TM during office hours .
As a result , the economic model developed scenarios for different RM classifications and their costs were estimated using bottom-up costing methods .
Despite wide variation in usual care and RM strategies , cost-effectiveness analyses suggest that TM during office hours was an optimal strategy ( in most costing scenarios ) .
However , clarity was lacking among descriptions of the components of RM packages and usual care and there was a lack of robust estimation of costs .
BACKGROUND Remote monitoring ( RM ) strategies have the potential to deliver specialised care and management to patients with heart failure ( HF ) .
OBJECTIVE To determine the clinical effectiveness and cost-effectiveness of home telemonitoring ( TM ) or structured telephone support ( STS ) strategies compared with usual care for adult patients who have been recently discharged ( within 28 days ) from acute care after a recent exacerbation of HF .
The review included r and omised controlled trials ( RCTs ) or observational cohort studies with a contemporaneous control group that included the following RM interventions : ( 1 ) TM ( including cardiovascular implanted monitoring devices ) with medical support provided during office hours or 24/7 ; ( 2 ) STS programmes delivered by human-to-human contact ( HH ) or human-to-machine interface ( HM ) .