The same methodology was used as described in section for the whole domain.

Introduction to Results section

591 records were identified through database searching and 28 additional records were identified through other sources; 428 remained after duplicates were removed. One hundred full-text articles were assessed for eligibility and after the exclusion of 76 full-text articles, five high quality SRs and 19 full text published RCTs were included in our SR (Appendix 3 and 4). Of the included RCTs, only three were judged to be of low risk of bias. The PRISMA flowchart outlining the study selection process is presented in Appendix 2.

Updating only one SR of already available SRs was not possible due to different, and a wide range of our research questions, as well as different inclusion criteria and followed-up duration of RCTs included. If data from existing SRs or HTAs was not available we used data from the included 19 RCTs.

Five high quality SRs were found to answer some of the assessment element questions {Feltner et al, 2014; Kotb et al, 2015; Pandor et al, 2013; Inglis et al, 2011; Clark et al, 2007}, details can be found in Appendix 3. Only three RCTs on STS in chronic heart failure patients {Laramee 2003, Riegel 2002, Riegel 2006} were included in all five SRs (see Appendix 5). Becausue not all assessment element questions could be answered by the results from the five included SRs, 19 published RCTs (Appendix 4 and 6), were included in order to answer the remaining assessment element questions. Out of them, 17 RCTs were already included in one or several of the five SRs (Appendix 5).

The two most recent RCTs, published by Angermann et al 2012 { } and Krum et al 2013 { } were not included in the SR published by Kotb et al 2015 { }, and RCT published by Krum et al 2013 { } was not included in the SR published by Feltner et al 2014 { }. Out of the 19 RCTs (see Appendix 4 and 6), only three  were judged to be of low risk of bias {DeBusk 2004, GESICA 2005, Chaudhry 2010}, five as unclear risk of bias {Tsuyuki 2004, Cleland 2005, Riegel 2006, Sisk 2006, Krum 2013} and the remaining 11 were rated as high risk of bias {Gattis 1999, Rainville 1999, Barth 2001, Riegel 2002, Laramee 2003, Galbreath 2004, DeWalt 2006, Ramachandran 2007, Wakefield 2008, Mortara 2009, Angermann 2012}. The majority of RCTs (17 RCTs) had a follow-up period of 6 or 12 months or more; more specifically two RCTs had 3 months period {Barth 2001, Laramee 2003}; eight had 6 months follow-up period {Gattis 1999, Riegel 2002, Tsuyuki 2004, Riegel 2006, Ramachandran 2007, Wakefield 2008, Chaudhry 2010, Angermann 2012}; for six  RCTs follow-up period was 12 months {Rainville 1999, DeBusk 2004, DeWalt 2006, Sisk 2006, Wakefield 2008, Krum 2013}. One RCT had follow-up period of 8 months {Cleland 2005}, one of 16 months {GESICA 2005} and one RCT had 18 months {Galbreath 2004} follow-up period. Only one ongoing RCT was found in publicly available register noted that participants were not yet being recruitinig (Appendix 7).

Answers on specific assessment element questions

All five high quality systematic reviews were used to answer the question ”What is the effects of Structured telephone support (STS) on overall mortality in adults with chronic heart failure, compared to standard care without Structured telephone support (STS)?” {Feltner et al, 2014; Kotb et al, 2015; Pandor et al, 2013; Inglis et al, 2011; Clark et al, 2007}, as well as two more recent RCTs {Angremann 2012, Krum 2013}, details can be found in Appendices 3 and 4.

Data found on overal mortality in STS group compared with usual care were conflicting. One SR Feltner et al, 2014 { }, including RCT published by Angermann 2012  { } and one SR with network meta analysis published by Kotb et al, 2015 { } were found which reported significantly lower overal mortality in STS group comparing with usual care. RCT published by Cleland 2005 { } found significantly lower overal mortality in STS group (UC=20 (24%) vs NTS=27 (16%), P=0.0397) as well.

The three other SRs and two out of 19  RCTs, reported non-significant difference in overall mortality in STS group compared to usual care {Pandor 2013, Inglis 2011, Clark 2007, Angermann 2012, Cleland 2005}.

Seven studies ({Krum et al 2013, Gatiss 1999, Rainville 1999, DeWalt et al 2006 { }, Chaudhry et al 2010 { }, Angermann et al 2013, DeBusk et al 2004) assessed the composite outcome (composite end point of all-cause death or hospitalisation or combined outcome of rehospitalisation, emergency department visit, or death). Only three of them {Krum et al 2013, Gatiss 1999, Rainville 1999}, found a significant reduction on this outcome.  

All but three trials in this SR were rated at a medium risk of bias; three trials were rated at high risk of bias primarily for high risk of selection bias and measurement bias. Most trials were conducted in the United States: three in multicenter settings and all others at a single center. Three trials were conducted in multicenter settings in Europe and Canada one trial was conducted at a single center in Brazil. In this most recent SR and HTA { }, STS interventions produced a mortality benefit, with  RR (95% CI) of 0.74 (0.56–0.97), at 3-6 months, with NNT of 27 (Table 1). Specific RR with 95% CI was listed for already included RCTs in previous SRs and in our new SR {Laramee 2003, Riegel 2006, Wakefield 2008, Angermann 2012}. According the Angermann et al, 2012 { } results, mortality was significantly lower in STS group comparing with usual care (HR, 0.62; 0.40–0.96; P=0.03)

Table 1. Mortality data from six RCTs on STS compared with usual care, Feltner et al, 2014 { }

Abbreviations: NNT = number needed to treat; RR = risk ratio; SOE = strength of evidence according the Feltner et al 2014 { }

Kotb et al, 2015 { } with direct comparisons of data from 15 trials showed mortality Odds Ratio (OR) of 0.85 (0.73 to 1.0), compared to usual care. In Network meta-analysis (NMA), compared to usual care, structured telephone support significantly reduced the odds of mortality (Odds Ratio 0.80; 95% Credible Intervals CrI [0.66 to 0.96]).

Pandor et al, 2013 { } included 11 studies evaluating STS [10 used standard telephone equipment using human to human (HH) support and one provided support via an automated telephone interactive response system (HM) with an alert system]; 1 study assessed both STS and telemonitoring compared with usual care. The duration of follow-up ranged from 6 months to 18 months.

Compared with usual care, STS HH did not show statistically significant benefit in reducing all-cause mortality [hazard ratio (HR) 0.77, 95% CrI 0.55 to 1.08]. No favourable effect on mortality was observed with STS HM.

In SR published by Inglis et al, 2011 { }, out of the 25 full text peer-reviewed studies included in the meta-analysis, 16 evaluated structured telephone support (5613 participants), 11 evaluated telemonitoring (2710 participants), and two tested both interventions. Structured telephone support demonstrating a non-significant positive effect on all-cause mortality (RR 0.88, 95% CI 0.76 to 1.01, P = 0.08) (Box 1). In sensitivity analysis done on 9 RCT with a follow-up period longer than 6 months, also included in our new SR, difference between two groups was not statistically significant  {Rainville 1999, DeBusk 2004, Galbreath 2004, Cleland 2005, GESICA 2005, DeWalt 2006, Sisk 2006, Wakefield 2008, Mortara 2009}.

Box 1. All-cause mortality, structured telephone support in comparison with usual care, in SR published by  Inglis et al, 2011 { }

All-cause mortality

STS vs UC RR 0.88 (95% CI 0.76 to 1.01, P = 0.08) (15 published trials, n= 5563)

Sensitivity analysis: Follow-up period (>6 months), 9 published trials, n=4292, RR 0.87 [0.74, 1.02]:

Cleland et al, 2005 (Struct Tele): 0.66 [0.40, 1.11]

DeBusket al, 2004: 0.74 [0.44, 1.26]

DeWalt et al, 2006: 0.79 [0.18, 3.37]

Galbreath et al, 2004: 0.70 [0.47, 1.04]

GESICA 2005 (DIAL): 0.88 [0.77, 1.00]

Mortara et al, 2009 (Struct Tele): 1.51 [0.62, 3.68]

Rainville et al, 1999: 0.25 [0.03, 2.04]

Sisk et al, 2006: 1.00 [0.57, 1.75]

Wakefield  et al, 2008: 1.12 [0.60, 2.09]

Adding two studies on structured telephone support (Angermann 2007; Krum 2009 (CHAT) which were not full peer-reviewed publications to the meta-analysis increased the effect of structured telephone support (RR 0.85, 95% CI 0.75 to 0.97, P = 0.02, I² 0%).

Abbreviations: RR = risk ratio; STS: structured telephone support; UC: usual care

telephone support, based on 10 RCTs results (also included in our SR) {Cleland 2005, Rainville 1999, Gattis 1999, Barth 2001, Riegel 2002, Laramee 2003, DeBusk 2004, Tsuyuki 2004, GESICA 2005, Riegel 2006} not statistically significant reduced all-cause mortality by 20% (8% to 31%); RR 0.85 (0.72 to 1.01, P=0.06, based on 482 deaths in 3542 patients)(Box 2).

Box 2. All-cause mortality, structured telephone support in comparison with usual care, in SR published by  Clark et al, 2007 { }

All-cause mortality

Structured telephone support RR 0.85 (0.72 to 1.01, P=0.06), based on 482 deaths in 3542 patients;

Cleland et al, 2005: RR 0.61 (0.40 to 0.94)

Gattis et al, 1999: RR 0.61 (0.15 to 2.46)

Rainville et al, 1999: RR 0.25 (0.03 to 2.01)

Barth et al, 2001: RR not estimated

Riegel et al, 2002: RR 0.88 (0.50 to 1.54)

Laramee et al, 2003: RR 0.90 (0.44 to 1.82)

DeBusk et al, 2004: RR 0.74 (0.44 to 1.26)

Tsuyuki et al, 2004: RR 1.30 (0.64 to 2.64)

GESICA Investigators 2005: RR 0.95 (0.75 to 1.20)

Riegel et al, 2006: RR 0.71 (0.26 to 1.93)

Angermann et al, 2012 { } in open, randomized, 2-armed, parallel-group, multicenter 6 months trial, aimed to clarify the mode of action of the program and individual patient requirements, thus providing a rational basis for more targeted health care strategies in heart failure, showed overall mortality significantly lower in intervention group in comparison to usual care group. Overall, 32 (9%) patients in the intervention group and 52 (14%) patients in the usual care group died (HR, 0.62; 0.40–0.96; P=0.03). Five of these deaths occurred after dropout (HNC: n=4, UC: n=1).

Krum et al, 2013 { } aimed at determining whether an automated telephone support system would improve quality of life and reduce death and hospital admissions for rural and remote heart failure patients in Australia, at 12 months follow up. This RCT reported that 16 out of 209 patients in the usual care (UC) group and 17 out of 170 patients in UC + Intervention (I) group died during the study. This resulted in an non statisticaly significant unadjusted hazard ratio (HR) for  all-cause death of 1.3 (range 0.65–2.77, P = 0.43) and an adjusted hazard ratio of 1.36 (0.63–2.93, P = 0.439).

Despite the fact that study Krum et al, 2013 { }  found no change in the primary endpoint (Packer clinical composite score, a clinical composite consisting of mortality, overnight hospitalization for worsened HF and NYHA class global self-assessment), the intervention did lead to a significant reduction in the risk of the composite of all-cause death or hospitalization, as well as all-cause hospitalization alone. 124 of 209 UC and 86 of 170 UC + I patients reached the endpoint of all-cause death or all-cause hospitalization. This resulted in an unadjusted hazard ratio of 0.75 (range 0.57–0.99, P = 0.045) and an adjusted hazard ratio of 0.70 (range 0.53–0.92, P = 0.011). The same is true for other RCTs that looked at composite end point of all cause mortality and rehospitalization for heart failure or all cause hospitalization {Gatiss 1999, Rainville 1999}. DeWalt et al 2006 { }, Chaudhry et al 2010 { }, and Angermann et al 2013 did not find any significant reduction in the risk of the composite of all-cause death or hospitalization or in the combined outcome of rehospitalization, emergency department visit, or death, DeBusk et al 2004 { }  .

 Details can be found in Appendix 3 and 4.

The same methodology was used as described in section for the whole domain.

Only three RCTs {Angremann 2012, Cleland 2005, DeBusk 2004} with different follow-up period (6, 8 and 12 months) were found to answer question ”What is the effects of Structured telephone support (STS) on disease-specific mortality in adults with chronic heart failure, compared to standard care without Structured telephone support (STS) ?”. They did not find any statistically significant different rates between two groups.

Angremann et al, 2012 { }, at 6 months, reported a lower disease specific mortality in the Intervention group  (22 [6%] versus 35 cases [10%]) in usual care group (UC), but this difference was not statistically significant; HR 0.66 (0.38 –1.12; P=0.12).  

Cleland et al, 2005 { } reported circulatory failure in UC=14 (16.5%) patients versus NTS=21 (12.3%) patients, as well as sudden death in UC=4 (4.7%) patients, in comparisons to NTS=5 (3%) patients, with a follow-up period of 8 months.

DeBusk et al, 2004 { } in randomized, controlled trial of usual care with nurse management versus usual care alone with aim to determine whether a telephone-mediated nurse care management program for heart failure reduced the rate of rehospitalization for heart failure and for all causes over a 12 months follow-up period, reported a disease specific mortality in UC: 29 (79%) versus STS: 21 (62%) patients. Of these deaths, 13 in the treatment group and 23 of 29 (79%) in the usual care group were due to cardiac causes.

Details could be found in Appendix 4.

The same methodology was used as described in section for the whole domain.

One SR {Inglis et al, 2011} with four RCTs reporting on this specific question (three overlapping with our SR {Ramachandran et al, 2007, Galbreath et al, 2004, Cleland et al, 2005} and one recently published full text RCT Angermann et al, 2012 { } were found to answer question ”How does Structured telephone support (STS) affect disease-specific symptoms and findings (severity, frequency) of adults with chronic heart failure, compared to standard care without Structured telephone support (STS)?”. )?”. Data on this outcome were conflicting.

In SR published by Inglis et al, 2011 { }, three RCTs (Angermann 2007 published only as Abstract; Ramachandran 2007, Galbreath 2004) out of four assessing it (Cleland et al 2004 in addition) showed a significant improvement in NYHA Functional Class. Ramachandran et al, 2007 { }, in RCT aimed to assess 6 months role of telephonic disease management programme in improving the quality-of-life (QOL) of patients with heart failure showed  that for every 20 patients in the intervention group, 14 patients improved by 1 functional class while in the control group this was observed in only 3 patients for every 20 treated. Significant improvement in functional capacity of patients was found in the intervention group compared with controls over a 6-month period, measured by the 6-minute walk test in the intervention group (from 202.2 [81.5] to 238.1 [100.9] metres, p<0.05) but not in the control group (193.8 [81.5] to 179.7 [112.0] metres). Galbreath et al, 2004 { } in RCT with aim to evaluate the effectiveness of telephonic disease management (DM) as a clinical and cost-containment strategy in both systolic and diastolic CHF over a longer time period (18 months) and with a larger and more heterogeneous sample than those of previous studies, reported a statistically significant improvements in NYHA class in intervention group (P=0.001), but 6-minute walk data from 217 patients in whom data were available at each visit showed no significant benefit from telephonic DM (P=0.08). Cleland et al, 2005 { } showed similar, not statisticaly different NYHA functional class after 8 months in the two groups. Angermann et al, 2012 { }, in published full text article, reported HR of 0.73 (0.53-1.00), statistically significant more favourable results regarding NYHA class (P=0.05), in Intervention group patients, after clinical evaluation at 6 months. No differences between groups were found regarding pump function, heart rate, and blood pressure.

Details could be found in Appendix 3 and 4.

The same methodology was used as described in section for the whole domain.

No RCTs were found to answer question “How does Structured telephone support (STS) affect the progression of chronic heart failure of adults patients, compared to standard care without Structured telephone support (STS)?”. Some indirect answers could be found in assessment element D0005.

The same methodology was used as described in section for the whole domain.

All five high quality systematic reviews were used to answer the question ”Does Structured telephone support (STS) impact on the re-hospitalization rate (disease-specific and all-cause) of adults with chronic heart failure, compared to standard care without Structured telephone support (STS)?” {Feltner et al, 2014; Kotb et al, 2015; Pandor et al, 2013; Inglis et al, 2011; Clark et al, 2007}, as well as two recently published RCTs {Angermann 2012, Krum 2013}; studies’ details can be found in Appendices 3 and 4.

Data found on all-cause and HF-specific re-hospitalization rate in STS group comparing with usual care were conflicting. The majority (included 5 published SRs) reported significantly lower HF-specific re-hospitalization rate in STS group {Feltner 2014, Kotb 2015, Pandor 2013, Inglis 2011, Clark 2007}. When sensitivity analysis was done including only RCT with follow-up period longer than 6 months this difference was not statistically significant anymore {Inglis 2011}.

On the contrary, two recently published RCTs  {Angermann 2012, Krum 2013} with 6 and 12 months follow-up period, respectively, reported a non-significant difference in HF-specific re-hospitalization between STS and Usual care groups.

In the most recent SR and HTA published by Feltner et al, 2014 { } whilst structured telephone support (STS) interventions statistically significant reduced HF-specific readmission (high strength of evidence, SOE) but not all-cause readmissions (moderate SOE), in follow-up period of 3-6 months, with NNT of 14 (Table 1).

Table 1. All-cause and heart failure (HF)-specific re-hospitalisation data from 8 RCTs on STS compared with usual care, at 3-6 months follow-up period, Feltner et al, 2014 { }

Abbreviations: NNT = number needed to treat; RR = risk ratio; SOE = strength of evidence assessed by Feltner et al 2014 { }

Kotb et al, 2015 { } in direct comparisons showed that statistically significant fewer patients receiving structured telephone support interventions were hospitalized for all causes (0.86 [0.77, 0.97)]  (data from 12 trials) and due to heart failure (0.76 [0.65, 0.89)] (data from 11 trials)  than patients who received usual care. In Network meta-analysis (NMA), compared to usual care, structured telephone support, significantly reduced the odds of hospitalizations due to heart failure (0.69; [0.56 to 0.85]). STS no longer found to significantly reduce all-cause hospitalization compared to usual care.

Pandor et al, 2013 { } showed that, compared with usual care, STS interventions had no major effect on all-cause hospitalisations. There were no major effects on HF-related hospitalisation for STS HM (HR 1.03, 95% CrI 0.66 to 1.54); STS HH (HR 0.77, 95% CrI 0.62 to 0.96) was associated with a statistically significant 23% reduction.

In SR published by Inglis et al, 2011 { }, based on data from 13 RCTs, Structured telephone support significantly reduced CHF-related hospitalisations (RR 0.77, 95% CI 0.68 to 0.87, P < 0.0001) (Box 1) as well as risk of all-cause hospitalization (RR 0.92, 95% CI 0.85 to 0.99, P = 0.02). In Sensitivity analysis including only RCTs with a follow-up period >6 months (6 published studies), both risks were not statistically significant between two groups.

Box 1. All-cause and HF-specific re-hospitalization, structured telephone support in comparison with usual care, in SR published by  Inglis et al, 2011 { }

All-cause hospitalisation (11 published studies, n=4295)

Structured telephone support was effective in reducing the risk of all-cause hospitalisation in patients with CHF (RR 0.92, 95% CI 0.85 to 0.99, P = 0.02, I² 24%).

Sensitivity analysis: Follow-up period (>6 months), 6 published studies, n=3058, RR 0.91 [0.83, 0.99]:

Cleland 2005 (Struct Tele): 0.91 [0.71, 1.16]

DeBusk  2004: 1.02 [0.85, 1.22]

GESICA 2005 (DIAL): 0.88 [0.77, 1.00]

Mortara 2009 (Struct Tele): 1.16 [0.82, 1.65]

Sisk 2006: 0.84 [0.64, 1.10]

Wakefield 2008: 0.70 [0.50, 0.97]

With the addition of one study of structured telephone support published as an abstract only (Krum 2009 (CHAT)), the effect of this intervention on all-cause hospitalisation in patients with CHF increased minimally (RR 0.90, 95% 0.84 to 0.97, P = 0.003, I² =32%.

CHF-related hospitalisation outcomes (13 studies, n=4269)

Structured telephone support was effective in reducing the proportion of patients with a CHF-related hospitalisation

RR 0.77, 95% CI 0.68 to 0.87, P < 0.0001, I² = 7%

Sensitivity analysis: Follow-up period (>6 months), 6 published studies, n=2948:  RR 0.76 [0.65, 0.89]

Cleland 2005 (Struct Tele): 0.70 [0.44, 1.10]

DeBusk 2004: 0.91 [0.61, 1.35]

GESICA 2005 (DIAL): 0.76 [0.61, 0.93]

Mortara 2009 (Struct Tele): 0.97 [0.57, 1.66]

Rainville 1999: 0.40 [0.15, 1.05]

Sisk 2006: 0.62 [0.36, 1.08]

In SR published by Clark et al, 2007 { }, based on 9 RCTs data, structured telephone support significantly reduced the rates of admission to hospital for chronic heart failure by 21% (95% confidence interval 11% to 31%), RR 0.78 (0.68 to 0.89), P=0.0003, but not all-cause hospital admission rate (based on 7 RCTs data provided) (Box 2).

Riegel et al 2006: 0.99 (0.74 to 1.33)

Riegel et al 2006: RR 0.90 (0.55 to 1.47)

Angermann et al. 2012 { } showed non statistically significant difference between STS and usual care groups on all-cause, P=0.28 and HF-specific re-hospitalization, P=0.36.

Krum et al, 2013 { } showed for all-cause hospitalization that there were significantly fewer patients hospitalized for any cause (74 vs. 114, adjusted HR 0.67 [95% CI 0.50–0.89], P = 0.006) and who died or were hospitalized (89 vs. 124, adjusted HR 0.70 [95% CI 0.53–0.92], P = 0.011), in the usual care (UC) + intervention group (I) versus UC group. Heart Failure (HF)-hospitalizations were reduced with UC+I (23 vs. 35, adjusted HR 0.81 [95% CI 0.44–1.38]), although this was not significant (P = 0.43). There were 16 deaths in the UC group and 17 in the UC+I group (P = 0.43). Authors concluded that although no difference was observed in the primary endpoint (Packer composite score), UC+I significantly reduced the number of HF patients hospitalized among a rural and remote cohort. These data suggest that telephone support may be an efficacious approach to improve clinical outcomes in rural and remote HF patients.

Details could be found in Appendix 3 and 4.

The same methodology was used as described in section for the whole domain.

One systematic review were used to answer the question ” Does Structured telephone support (STS) impact on the emergency room visit rate (disease-specific) of adults with chronic heart failure, compared to standard care without Structured telephone support (STS)?” {Feltner et al, 2014}, as well as 7 RCTs out of 19 included in our new SR {Ramachandran 2007, Sisk 2006, Cleland 2005, Tsuyuki 2004, Galbreath 2004, DeBusk 2004, Barth 2001}; details can be found in Appendices 3 and 4.

Data found on the emergency room (ER) visit rate in STS group comparing with usual care were conflicting, but majority of the retrieved evidence found no significant difference in the number of emergency room visits in either group.

The most recent SR and HTA published by Feltner et al, 2014 { } reported that STS interventions had no effect on the rate of ER visits over 3 to 6 months (low SOE). Six STS trials provided data on ER visits at different time points and using different methods; two of them were also included in our SR { Barth 2001, Tsuyuki 2004}. Tsuyuki 2004}. Individual data of these two and of additional five RCTs included in our review are presented below.  

Ramachandran et al, 2007 { }, in a RCT aimed to assess 6 months role of telephonic disease management programme in improving the quality-of-life (QOL) of patients with heart failure, found no significant difference in the number of emergency room visits between the two groups.

Sisk et al, 2006 { } found no significant difference in the number of emergency room visits (total ER visit, 157 usual care group vs 147 in STS group, in follow-up period of 12 months.

Cleland et al, 2005 { } showed a significant difference in the number of emergency room visits in favour of usual care group (total ER visit, 8 usual care group vs 54 in STS group, in period of 8 months (Total/1000 days at risk (95% CI): UC= 0.5 (0.2 to 0.8) vs NTS= 1.6 (1.2 to 2.0).

Tsuyuki et al, 2004 { } presented a non-significant difference in all cause  of emergency room visits between groups (UC=69 vs STS=41, p=0.206), but significant difference in the number of cardiovascular emergency room visits (UC=49 vs STS=20, p=0.030).

Galbreath et al, 2004 { }  in a RCT with a treatment period of 18 months, showed that total and CHF-related healthcare utilization, including medications, office or emergency department visits, procedures, or hospitalizations, was not decreased by DM.

In the RCT published by DeBusk et al, 2004 { }  no significant difference in the number of emergency room visits was found: 126 out of 228 patients (55%) in the care management group made 1 or more emergency department visits for any cause compared with 132 out of the 234 patients (56%) in the usual care group. The mean number of emergency department visits in the treatment and usual care groups during the first year of follow-up was 3.2 (median, 2.0) and 3.5 (median, 2.0), respectively.

In the RCT published by Barth et al, 2001, { } no significant difference was found: none of the patients in the experimental group had any unexpected emergency department visits during the study period of 3 months. One patient from the control group had an unexpected visit to a local emergency department due to CHF.

 Details could be found in Appendix 3 and 4.

The same methodology was used as described in section for the whole domain.

Assessment element questions EFF6b and EFF6c, based on assessment element: D0023, were answered together:

To answer question ”Does Structured telephone support (STS) impact on the cardiology visit rate (disease-specific) of adults with chronic heart failure, compared to standard care without Structured telephone support (STS)?” 7, out of 19 RCTs were found {Barth 2001, Riegel 2002, Laramee 2003, DeBusk 2004, Tsuyuki 2004, Cleland 2005, Angermann 2012}, and one more RCT was found {Krum 2013} to answer question ”Does Structured telephone support (STS) impact on the primary care visit rate (disease-specific) of adults with chronic heart failure, compared to standard care without Structured telephone support (STS)?”. Not all RCTs were specific on cardiology visit rate nor on primary care visit rate. Six RCTs (on cardiology visit rate) found no significant difference, and one {Cleland 2005} found difference, in favour of control group. Two found a difference on primary care visit rate; one in favour of control group and one in favour of STS group {Cleland 2005, Krum 2013}. RCTs varied in follow-up duration period (3 month to 12 months period) as well in sample size.

Barth et al, 2001 { }, in 3 months follow-up period showed that CHF patients who received the structured nurse managed post discharge program did not have any unexpected physician office visit due to exacerbation of CHF during the time they were enrolled in the study. One participant in the control group had an unexpected visit to the physician’s office for adjustment of medications.

Riegel et al, 2002 { }, during a 6 months period, showed a non-significant difference in physician office visits (5.63±3.6 in intervention group vs 6.17±4.87 in usual care group).

Laramee et al, 2003 { }, during a 3 months period showed that no significant differences were found in outpatient and inpatient resource utilization between the groups.

DeBusk et al, 2004 { }, showed that in the 12 months, patients in both groups had an average of 3 cardiology outpatient visits, 6 internal medicine visits, and 4 non–internal medicine visits.

Tsuyuki et al, 2004, presented that in 6 months no significant difference was found in physician visits all-cause (p=0.795) or cardiovascular cause (p=0.366) between groups.

Cleland et al, 2005 { }, in 8 months period showed a higher rate of both, cardiology visit (UC=34 vs NTS=117) and primary care visit rates (UC=119 vs NTS=602) for patients in the intervention group. Authors discussed that patient contacts were evaluated only once every four months in the usual care group compared with monthly in NTS group, which may led to under-reporting of contacts in the control group.

Angermann et al, 2012 { }, during the 6 months period, showed a non-significant difference: across the entire study population, mean numbers of visits to cardiologists were 0.7±2.3 and 0.7±2.6 per patient in HNC and UC, respectively (P=0.86), and of visits to other specialists were 1.3±5.4 and 2.1±9.9, respectively (P=0.17). In HNC, this included also specialist care arranged by the INH team. Average numbers of contacts per alive patient/month, out of hospital, and under observation were 2.4±1.8 versus 2.4±2.1 (GP p=0.82), 0.1±0.4 versus 0.1±0.4 (cardiologists, P=0.88), and 0.2±0.9 versus 0.4±1.7 (other specialists, P=0.12) in HNC and UC, respectively.

Authors {Angermann et al, 2012},  showed non-significant difference for GPs visits as well: across the entire study population, mean contact frequencies with GPs (home and office visits) were 13.5±10.6 in HNC and 12.9±11.1 in UC, respectively (P=0.46). Average numbers of contacts per patient month alive, out of hospital, and under observation were 2.4±1.8 versus 2.4±2.1 (GP p=0.82), 0.1±0.4 versus 0.1±0.4 in HNC and UC, respectively.

Krum et al, 2013, during 12 months period, showed that patients in the usual care group visited their general practitioner more frequently compared with those in UC + intervention group (12.55 GP visits/patient [UC] vs. 5.85 GP visits/patient [UC + I]). Reduction in the utilization of general practitioners, with the control group visiting their general practitioner more than twice as often as the intervention group, may be due to compliance (in 65%) with the automated telephone support system in the intervention group, reducing the need for participants in the intervention group to visit their general practitioner.

Details could be found in Appendix 4.

The same methodology was used as described in section for the whole domain.

Assessment element questions EFF6b and EFF6c, based on assessment element: D0023, were answered together, please see above.

The same methodology was used as described in section for the whole domain.

Assessment element questions D0012 and D0013 (EFF7 and EFF8) were answered together:

Three SRs were used to answer ”What is the effect of Structured telephone support (STS) on generic health-related quality of life of adults with chronic heart failure, compared to standard care without  Structured telephone support (STS)?” and ”What is the effect of Structured telephone support (STS) on disease specific quality of life of adults with chronic heart failure, compared to standard care without Structured telephone support (STS)?” {Feltner 2014, Pandor 2013, Inglis 2011}, with 8 RCTs overlappin with those from our sample of 19 RCTs {Riegel 2006, Angermann 2012, Barth 2001, Wakefield 2008, DeWalt 2006; GESICA 2005; Ramachandran 2007; Sisk 2006}. Data found was controversial, but majority presented statisticaly significant QoL improvements.

In the most recent SR and HTA published by Feltner et al, 2014 { } STS interventions did not improve HF-specific quality of life at 3 or 6 months. Meta-analysis {Feltner et al, 2014} (two trials, Riegel et al, 2006 and Dominiquez et al, 2011) found no difference in Minnesota Living With Health Failure Questionnaire (MLWHFQ) scores among patients receiving STS and those receiving usual care at either 3 months (WMD, -3.78; 95% CI, -10.39 to 2.83) or 6 months (WMD, -7.14; 95% CI, -21.07 to 6.78).

Three additional trials reported on quality of life at 6 months {Angermann et al, 2012, Dunagan et al, 2005, Barth et al, 2001}; in one trial, patients receiving STS had significantly better NYHA classification and SF-36 physical functioning subscale and physical health summary measure scores at 3 months than patients receiving usual care {Angermann et al, 2012}. Another trial reported on physical and emotional subscales of the MLWHFQ and on physical and mental health summary measures of the SF-12; patients receiving STS had significantly better scores on the SF-12 physical scale than controls at 6 months, but all other comparisons were not significant {Dunagan et al, 2005}.

Barth et al, 2001 { } found no significant difference between the groups in the emotional dimension of the questionnaire prior to discharge (t = .36, p = .718) or the physical dimension of the questionnaire prior to discharge (t =.83, p = .414). The total scores for the two groups on the LHFQ were not significantly different (t = .22, p =.829) before discharge from the acute-care setting. A t test for paired samples was done on the scores of the LHFQ obtained from the participants at the conclusion of their involvement in the study. Within the control group, the comparison of means on the emotional dimension of the LHFQ predischarge with the emotional dimension of the LHFQ at the conclusion of the study revealed that there was not a statistically significant difference (t = 2.53, p = .022). There also was not a statistically significant difference between the prescores and postscores in the control group on the physical dimension (t = .93, p = .367) or for the total scores (t = 1.81, p = .088).

A paired sample t test was used to determine if there was a difference in LHFQ scores prior to discharge and at the study conclusion for the experimental group. All three areas were found to be statistically significant, with participants showing improvement in their perceived quality of life at the conclusion of their involvement in the study. Participants in the experimental group showed significant improvement in the physical dimension (t = 6.63, p ≤.0005), the emotional dimension (t = 4.55, p ≤ .0005), and the total LHFQ score (t = 7.80, p ≤ .0005).

Pandor et al, 2013 { } showed that STS improved QoL. Three of the four STS studies reported improvements in QoL {Angermann 2012, Barth 2001, Wakefield 2008}, with significant improvements in physical (p = 0.03) {Angermann 2012} and overall (MLHFQ, p < 0.001) measures {Barth 2001, Wakefield 2008}. One study found no significant differences between groups in either the MLHFQ or the EQ-5D measure {Riegel 2006}.

In SR published by Inglis et al, 2011 { }, Quality of Life (QoL) was a secondary outcome for 16 of the 30 included studies.

Several different psychometric tools were used for evaluation (Chronic Heart Failure Symptomatology Questionnaire (CHFSQ); Minnesota Living with Heart Failure Questionnaire (MLWHFQ); Kansas City Cardiomyopathy Questionnaire (KCCQ); Short Form 12 Item (SF-12); Short Form 36 Item (SF-36) and Health Distress Score (HDS)).

Six structured telephone support studies {Angermann 2007; DeWalt 2006; GESICA 2005 (DIAL); Ramachandran 2007; Sisk 2006; Wakefield 2008} demonstrated a significant improvements in component scores or overall QoL measures. Studies which assessed both telemonitoring and structured telephone support {Cleland 2005, Mortara 2009} did not report QoL outcomes.

Details could be found in Appendix 3 and 4.

The same methodology was used as described in section for the whole domain.

To answer on ”What is the effect of Structured telephone support (STS) on disease specific quality of life of adults with chronic heart failure, compared to standard care without Structured telephone support (STS)?” please see assessment element D0012.

The same methodology was used as described in section for the whole domain.

To answer on ”What is the effect of Structured telephone support (STS) on body functions of adults with chronic heart failure, compared to standard care without Structured telephone support (STS)?” please look assessment element D0005.

The same methodology was used as described in section for the whole domain.

No SRs or HTAs or RCTs that addressed question “What is the effect of Structured telephone support (STS) on work ability of adults with chronic heart failure, compared to standard care without Structured telephone support (STS)?” were identified.

The same methodology was used as described in section for the whole domain.

No SRs or HTAs or RCTs that addressed question “What is the effect of Structured telephone support (STS) on return to previous living conditions of adults with chronic heart failure, compared to standard care without Structured telephone support (STS)?” were identified.

The same methodology was used as described in section for the whole domain.

No SRs or HTAs or RCTs that addressed question “How does Structured telephone support (STS) affects activities of daily living of adults with chronic heart failure, compared to standard care without Structured telephone support (STS)?” were identified.

The same methodology was used as described in section for the whole domain.

No SRs or HTAs or RCTs that addressed question “Was the use of Structured telephone support (STS) worthwhile?” were identified.

The same methodology was used as described in section for the whole domain.

No SRs or HTAs or RCTs that addressed question “Are adults with chronic heart failure willing to use the Structured telephone support (STS) again?” were identified.

The same methodology was used as described in section for the whole domain.

Due the fact that little evidence identified on the potential harms of STS (please see SAF Domain) it is not possible to answer this question: “What are the overall benefits and harms of the Structured telephone support (STS) in adults with chronic heart failure?”.