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 ) .
Framework for design and evaluation of complex interventions to improve health
R and omised controlled trials are widely accepted as the most reliable method of determining effectiveness , but most trials have evaluated the effects of a single intervention such as a drug . Recognition is increasing that other , non-pharmacological interventions should also be rigorously evaluated.1 - 3 This paper examines the design and execution of research required to address the additional problems result ing from evaluation of complex interventions —that is , those “ made up of various interconnecting parts.”4 The issues dealt with are discussed in a longer Medical Research Council paper ( www.mrc.ac.uk/complex_packages.html ) . We focus on r and omised trials but believe that this approach could be adapted to other design s when they are more appropriate . # # # # Summary points Complex interventions are those that include several components The evaluation of complex interventions is difficult because of problems of developing , identifying , documenting , and reproducing the intervention A phased approach to the development and evaluation of complex interventions is proposed to help research ers define clearly where they are in the research process Evaluation of complex interventions requires use of qualitative and quantitative evidence There are specific difficulties in defining , developing , documenting , and reproducing complex interventions that are subject to more variation than a drug . A typical example would be the design of a trial to evaluate the  benefits of specialist stroke units .  Such a trial would have to consider the expertise of various health professionals as well as investigations , drugs , treatment guidelines , and arrangements for discharge and follow up . Stroke units may also vary in terms of organisation , management , and skill mix . The active components of the stroke unit may be difficult to specify , making it difficult to replicate the intervention . The box gives other examples of complex interventions . # # # # Examples of complex interventions Service delivery and organisation : Stroke units Hospital at home Interventions directed at health professionals ' behaviour : Strategies for implementing guidelines Computerised decision support Community interventions : Community
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 ) .