Result card

  • SAF1a: What is the frequency of all AEs with Structured telephone support (STS) in adults with chronic heart failure, compared to standard care without Structured telephone support (STS)?
  • SAF1b: What is the frequency of discontinuation of Structured telephone support (STS) due to adverse events in adults with chronic heart failure, compared to standard care without Structured telephone support (STS)? Jump to
  • SAF1c: What is the frequency of and what are the serious-SAEs with Structured telephone support (STS) in adults with chronic heart failure, compared to standard care without Structured telephone support (STS)? Jump to
  • SAF1d: What is the frequency of SAE leading to deaths with Structured telephone support (STS) in adults with chronic heart failure, compared to standard care without Structured telephone support (STS)? Jump to
  • SAF1e: What are the most frequent AEs with Structured telephone support (STS) in adults with chronic heart failure, compared to standard care without Structured telephone support (STS)? Jump to
English

What is the frequency of all AEs with Structured telephone support (STS) in adults with chronic heart failure, compared to standard care without Structured telephone support (STS)?

Authors: Mirjana Huic, Pernilla Östlund, Romana Tandara Hacek, Jelena Barbaric, Marius Ciutan, Silvia Florescu, Silvia Gabriela Scintee

Internal reviewers: Y. Triñanes, H. Stürzlinger, J. Gonzalez-Enriquez, A. Lo Scalzo, S. Maltoni

Acknowledgments: We would like to thank Ms Ana Utrobičić, MLIS, the Head of the Central Medical Library at the University of Split School of Medicine, Split, Croatia for development of systematic literature search strategy and performed search on standard medical and HTA databases.

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 duration of follow-up 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

One SRs, published by Feltner et al, 2014 { } and 19 RCTs were included to answer domain assessment element questions { }. Little evidence identified on the potential harms of STS.

Feltner et al, 2014 { } included 13 RCTs described in 15 publications comparing STS with usual care. Most trials averaged 1 or 2 calls during the intervention period, with the first contact occurring within 7 days of discharge. Interventions differed in whether predischarge education was delivered with STS or not. Most trials included a patient-initiated hotline for questions or additional support. One three-arm trial compared two modes of delivering STS (standard telephone versus videophone) with usual care.  Trial sample sizes ranged from 32 to 715; only one trial reported a readmission rate at 30 days.

 

All but three trials included in this SR were rated as at medium risk of bias; three trials 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 and one trial was conducted at a single center in Brazil (Appendix 3). In this most recent SR and HTA {Feltner et al, 2014}, no evidence on potential harms was found on STS interventions.

None of 19 included RCTs specifically predefined adverse events (AEs) as primary or secondary outcomes. The same is true for one identified trial in publicly available clinical trial register (Appendix 4 and 7).

Only one RCT specifically mentioned AEs and only one RCT provided explanation for the reason why they did not monitor AEs. Chaudhry et al, 2010 { }, in 6 months treatment period, multicenter, randomized, single-blind, low risk of bias controlled trial, with aim  to assess whether telemonitoring would reduce the combined end point of readmission or death from any cause among patients recently hospitalized for heart failure, no adverse events were reported. Authors discussed that the primary anticipated adverse event associated with telemonitoring was a delay in seeking care for urgent or emergency situations because of a belief that the telemonitoring data would immediately alert clinicians. Sisk et al, 2006, explained that since both, nurse management and usual care, involved only services delivered in routine practice, the study did not monitor adverse effects.

Details could be found in Appendices 3, 4 and 7:

Appendix 3  Characteristics of included secondary studies: Systematic reviews/HTA, main study findings and authors conclusions. Assessing the quality of included SRs – AMSTAR Criteria

Appendix 4 RCTs included in SR of effectiveness and safety: Evidence tables and Risk of bias tables

Appendix 7 List of Ongoing RCTs in clinical trials registries

Critical
Partially
Huic M et al. Result Card SAF1a In: Huic M et al. Safety In: Jefferson T, Cerbo M, Vicari N [eds.]. Structured telephone support (STS) for adult patients with chronic heart failure [Core HTA], Agenas - Agenzia nazionale per i servizi sanitari regionali ; 2015. [cited 16 June 2021]. Available from: http://corehta.info/ViewCover.aspx?id=305

What is the frequency of discontinuation of Structured telephone support (STS) due to adverse events in adults with chronic heart failure, compared to standard care without Structured telephone support (STS)?

Authors: Mirjana Huic, Pernilla Östlund, Romana Tandara Hacek, Jelena Barbaric, Marius Ciutan, Silvia Florescu, Silvia Gabriela Scintee

Internal reviewers: Y. Triñanes, H. Stürzlinger, J. Gonzalez-Enriquez, A. Lo Scalzo, S. Maltoni

Acknowledgments: We would like to thank Ms Ana Utrobičić, MLIS, the Head of the Central Medical Library at the University of Split School of Medicine, Split, Croatia for development of systematic literature search strategy and performed search on standard medical and HTA databases.

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

To answer on ”What is the frequency of discontinuation of Structured telephone support (STS)  due to adverse events in adults with chronic heart failure, compared to standard care without Structured telephone support (STS)?” please see assessment element C0001.

Critical
Partially
Huic M et al. Result Card SAF1b In: Huic M et al. Safety In: Jefferson T, Cerbo M, Vicari N [eds.]. Structured telephone support (STS) for adult patients with chronic heart failure [Core HTA], Agenas - Agenzia nazionale per i servizi sanitari regionali ; 2015. [cited 16 June 2021]. Available from: http://corehta.info/ViewCover.aspx?id=305

What is the frequency of and what are the serious-SAEs with Structured telephone support (STS) in adults with chronic heart failure, compared to standard care without Structured telephone support (STS)?

Authors: Mirjana Huic, Pernilla Östlund, Romana Tandara Hacek, Jelena Barbaric, Marius Ciutan, Silvia Florescu, Silvia Gabriela Scintee

Internal reviewers: Y. Triñanes, H. Stürzlinger, J. Gonzalez-Enriquez, A. Lo Scalzo, S. Maltoni

Acknowledgments: We would like to thank Ms Ana Utrobičić, MLIS, the Head of the Central Medical Library at the University of Split School of Medicine, Split, Croatia for development of systematic literature search strategy and performed search on standard medical and HTA databases.

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

To answer on ”What is the frequency of and what are the serious-SAEs with Structured telephone support (STS) in adults with chronic heart failure, compared to standard care without Structured telephone support (STS)?” please see assessment element C0001.

Critical
Partially
Huic M et al. Result Card SAF1c In: Huic M et al. Safety In: Jefferson T, Cerbo M, Vicari N [eds.]. Structured telephone support (STS) for adult patients with chronic heart failure [Core HTA], Agenas - Agenzia nazionale per i servizi sanitari regionali ; 2015. [cited 16 June 2021]. Available from: http://corehta.info/ViewCover.aspx?id=305

What is the frequency of SAE leading to deaths with Structured telephone support (STS) in adults with chronic heart failure, compared to standard care without Structured telephone support (STS)?

Authors: Mirjana Huic, Pernilla Östlund, Romana Tandara Hacek, Jelena Barbaric, Marius Ciutan, Silvia Florescu, Silvia Gabriela Scintee

Internal reviewers: Y. Triñanes, H. Stürzlinger, J. Gonzalez-Enriquez, A. Lo Scalzo, S. Maltoni

Acknowledgments: We would like to thank Ms Ana Utrobičić, MLIS, the Head of the Central Medical Library at the University of Split School of Medicine, Split, Croatia for development of systematic literature search strategy and performed search on standard medical and HTA databases.

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

To answer on ” What is the frequency of SAE leading to deaths with Structured telephone support (STS) in adults with chronic heart failure, compared to standard care without Structured telephone support (STS)?” please see assessment element C0001.

Critical
Partially
Huic M et al. Result Card SAF1d In: Huic M et al. Safety In: Jefferson T, Cerbo M, Vicari N [eds.]. Structured telephone support (STS) for adult patients with chronic heart failure [Core HTA], Agenas - Agenzia nazionale per i servizi sanitari regionali ; 2015. [cited 16 June 2021]. Available from: http://corehta.info/ViewCover.aspx?id=305

What are the most frequent AEs with Structured telephone support (STS) in adults with chronic heart failure, compared to standard care without Structured telephone support (STS)?

Authors: Mirjana Huic, Pernilla Östlund, Romana Tandara Hacek, Jelena Barbaric, Marius Ciutan, Silvia Florescu, Silvia Gabriela Scintee

Internal reviewers: Y. Triñanes, H. Stürzlinger, J. Gonzalez-Enriquez, A. Lo Scalzo, S. Maltoni

Acknowledgments: We would like to thank Ms Ana Utrobičić, MLIS, the Head of the Central Medical Library at the University of Split School of Medicine, Split, Croatia for development of systematic literature search strategy and performed search on standard medical and HTA databases.

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

Please see assessment element C0001.

Critical
Partially
Huic M et al. Result Card SAF1e In: Huic M et al. Safety In: Jefferson T, Cerbo M, Vicari N [eds.]. Structured telephone support (STS) for adult patients with chronic heart failure [Core HTA], Agenas - Agenzia nazionale per i servizi sanitari regionali ; 2015. [cited 16 June 2021]. Available from: http://corehta.info/ViewCover.aspx?id=305

References