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QUESTION | |
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05. Should education and monitoring techniques vs. usual care be used for adult patients living with heart failure? | |
Population | adult patients living with heart failure |
Intervention | Monitoring techniques See more |
Comparison | Usual Care |
Main outcomes | Adherence; All cause admisions; All cause readmisions; Heart failure admissions; Heart failure readmissions; Knowledge; Mortality; Quality of life; Self-efficacy; |
Setting | European Union, outpatient care |
Perspective | Clinical recommendation- Population perspective |
Background | Heart failure (HF), a complex clinical syndrome, is considered a global pandemic with an increasing overall incidence and prevalence due to ageing of population (Savarese G et al., 2017). HF clinical practice guideline self-management strategies are recommended to increase quality of life and to reduce the risk of HF hospitalization and mortality. However, there are still gaps in the evidence especially regarding the comparative effectiveness and cost-effectiveness of the strategies, due to variations in study locations and time of occurrence and to suboptimal reporting of patient-relevant outcomes (ESC 2021, Jonkman NH et al., 2016, Takeda A et al., 2019). |
Conflict of interest |
This work was supported by the EU Horizon 2020 research and innovation programme (grant agreement no. 754936). The funder had no role in developing the protocol or obtaining the results for this study. |
ASSESSMENT | |||||||||||||||||||||||||||||
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Priority of problem Is the problem a priority? |
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JUDGEMENT | RESEARCH EVIDENCE | ||||||||||||||||||||||||||||
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Heart failure (HF), a complex clinical syndrome, is considered a global pandemic with an increasing overall incidence and prevalence due to ageing of population (Savarese G et al., 2017). HF clinical practice guideline self-management strategies are recommended to increase quality of life and to reduce the risk of HF hospitalization and mortality. However, there are still gaps in the evidence especially regarding the comparative effectiveness and cost-effectiveness of the strategies, due to variations in study locations and time of occurrence and to suboptimal reporting of patient-relevant outcomes (ESC 2021, Jonkman NH et al., 2016, Takeda A et al., 2019. |
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Desirable Effects How substantial are the desirable anticipated effects? |
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JUDGEMENT | RESEARCH EVIDENCE | ||||||||||||||||||||||||||||
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View summary of findings of network meta-analysis
View summary of findings of component network meta-analysis |
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ADDITIONAL CONSIDERATIONS | |||||||||||||||||||||||||||||
The guideline panel judged the desirable effects as large.
No data available for the rest of critical/important outcomes.
Proportion of direct evidence contributing to the final NMA estimate per outcome: Adherence to medication: 100% All-cause admission: 89% All-cause readmission: 95% Emergency: 100% Exercise_capacity: 82% Heart failure admission: 98% Heart failure readmission: 85% Knowledge: 79% Mortality (All cause): 90% Quality of life: 76% Self-efficacy: 89%
Component Network Meta-analysis: - Adherence to medication: the components with larger effects are education (E) and monitoring techniques (MT) - Knowledge: the components with larger effects are education (E) and monitoring techniques (MT) - Quality of life: the components with larger effects are education (E) - Self-efficacy: the components with larger effects are education (E) and monitoring techniques (MT)
Studies that include this SMI: Kalter-Leibovici-2017 - Disease management, delivered by multi-disciplinary teams, included coordination of care, patient education, monitoring disease symptoms and patient adherence to medication regimen, titration of drug therapy, and home tele-monitoring of body weight, blood pressure and heart rate. - 1 face-to-face session, phone calls and internet-based contacts when needed; all individual - Duration unclear - Expected patient (or carer) self-management behaviours: o Clinical management § Self-monitoring § Medication use and adherence § Early recognition of symptoms o Working with healthcare and/or social care providers § Communication with health care and/or social care provider
Koehler-2010 - Daily remote device monitoring (electrocardiogram, blood pressure, body weight) coupled with medical telephone support - 1 face-to-face session, phone calls and specific device contacts when needed; all individual - Duration unclear - Expected patient (or carer) self-management behaviours: o Clinical management § Condition-specific behaviours § Self-monitoring § Early recognition of symptoms § Asking for professional help or emergency care when needed § Managing devices o Working with healthcare and/or social care providers § Communication with health care and/or social care provider
Mortara-2009 - Home telemonitoring to monitor clinical and physiological parameters - Face-to-face sessions (number unclear), 12 phone calls; all individual - Duration 12 months - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Eating behaviours § Doing physical activity o Clinical management § Self-monitoring § Managing devices
Holland-2007 - Two home visits by one of 17 community pharmacists within two and eight weeks of discharge. Pharmacists reviewed drugs and gave symptom self-management and lifestyle advice. - 2 individual face-to-face sessions - Duration 68 weeks - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Eating behaviours § Doing physical activity § Smoking cessation or reduction o Clinical management § Self-monitoring § Medication use and adherence
Brotons-2009 - Monthly visits to the patients’ home were scheduled for the entire year. In addition, nurses contacted patients by telephone every 15 days to evaluate their clinical status. - 12 face-to-face sessions, 24 phone calls; all individual - Duration 12 months - Expected patient (or carer) self-management behaviours: o Clinical management § Condition-specific behaviours § Medication use and adherence
Deek-2017 - Patients and their family caregivers were provided with a comprehensive, culturally appropriate, educational session on self-care maintenance and symptom management along with self-care resources - Sessions unclear - Duration unclear - Expected patient (or carer) self-management behaviours: o Clinical management § Self-monitoring § Medication use and adherence § Managing devices
Nguyen-2007 - Close follow-up by a nurse-led multidisciplinary team at a maximum of 2 weeks after randomization, then on a monthly basis or more frequently if needed - 7 face-to-face sessions, phone calls when needed; all individual - Duration 6 months - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Eating behaviours § Doing physical activity o Clinical management § Self-monitoring § Medication use and adherence § Early recognition of symptoms
Sadik-2005 - Pharmacist-led pharmaceutical care program - 4 face-to-face sessions, phone calls when needed; all individual - Duration 12 months - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Eating behaviours § Doing physical activity o Clinical management § Self-monitoring § Medication use and adherence § Early recognition of symptoms § Asking for professional help or emergency care when needed § Physical management
Modeling estimations for long term consequences We used the COMPAR-EU heart failure (HF) model developed for the cost-effectiveness analysis to also inform about long-term health outcomes. Decision analytic models can provide valuable information for outcomes when empirical evidence is not available or is unfeasible (Trikalinos TA, 2009). The following events were estimated over a lifetime and informed by the NMA effect of each SMI on all-cause mortality and all-cause admission outcomes. We suggest cautious interpretation as the certainty of the evidence for those input parameters was low to very low across comparisons. Long-term model outcomes: - Life-Years (LY): no days of additional life per patient - Effect on the all-cause admission: reduction in hospital costs of 720 euros per patient. |
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Undesirable Effects How substantial are the undesirable anticipated effects? |
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View summary of findings of network meta-analysis
There are no undesirable effects observed. |
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ADDITIONAL CONSIDERATIONS | |||||||||||||||||||||||||||||
The guideline panel judged the undesirable effects as trivial or marginal. |
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Certainty of the evidence What is the overall certainty of the evidence of effects? |
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ADDITIONAL CONSIDERATIONS | |||||||||||||||||||||||||||||
The guideline panel has judged the certainty of the evidence as Very low.
Certainty of the evidence was downgraded due to heterogeneity (of interventions and severity of disease), risk of bias, and imprecision. |
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Values Is there important uncertainty about or variability in how much people value the main outcomes? |
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An overview of systematic reviews provided information about how patients value several of the outcomes of interest (critical/important) included in this clinical question:
References
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ADDITIONAL CONSIDERATIONS | |||||||||||||||||||||||||||||
The guideline panel judged that there is probably no important uncertainty or variabilty on how patients value the main outcomes.
The panel agreed that there is some variability on how patients value the outcomes, since preferences will vary based on patients' particular starting point, and their disease progression. The panel also noted, that the variability on how patients value the main outcomes, could also depend on the intensity of monitoring. |
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Balance of effects Does the balance between desirable and undesirable effects favor the intervention or the comparison? |
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ADDITIONAL CONSIDERATIONS | |||||||||||||||||||||||||||||
The guideline panel judged that the balance of effects probably favours the intervention. This is due to the moderate desirable effects, the trivial undesirable effects, the probably no important uncertainty and variability on how patients value outcomes, as well as the very low certainty of evidence of effects. |
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Resources required How large are the resource requirements (costs)? |
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Estimated costs for the intervention across all types of self-management interventions (SMIs), as described in the included studies of the network meta-analysis, were on average 794 euros per patient, with a range from 85 to 2,045 euros. Please note that this average/range estimate has been based on ten cost estimates of SMIs for HF reported in publications.
Furthermore, most of the SMIs were an element of a management program, which means that the other costs of the management program are not taken into account in the intervention costs.
Model analyses showed that over lifetime the total costs (without cost of the intervention) for the SMI were 720 euros lower compared to usual care. This cost decrease was mainly the result of reduction in number of admissions. This SMI only affect the number of admissions.
References Trikalinos TA, Siebert U, Lau J. Decision-analytic modeling to evaluate benefits and harms of medical tests: uses and limitations. Med Decis Making. 2009 Sep-Oct;29(5):E22-9. Girling A, Lilford R, Cole A, Young T. Headroom approach to device development: current and future directions. Int J Technol Assess Health Care. 2015 Jan;31(5):331-8. |
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ADDITIONAL CONSIDERATIONS | |||||||||||||||||||||||||||||
Despite the scarcity of data in available publications, and the important variability in the characteristics of self-monitoring interventions the panel considered that the resources required varies for this SMI.
Resource use and costing data for SMIs should be interpreted with caution. We could not provide cost for any specific type of SMI intervention, because in many publications detailed information needed to estimate the intervention cost was missing (for example number of sessions, average group size or duration of sessions). As an alternative, we searched for intervention cost estimates as presented by the authors of publications and used the average value as an estimate of the average costs of SMI programs for HF in general. |
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Certainty of evidence of required resources What is the certainty of the evidence of resource requirements (costs)? |
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ADDITIONAL CONSIDERATIONS | |||||||||||||||||||||||||||||
The guideline panel agreed on a very low certainty of the evidence on this domain .
Resource use and costing data for SMIs should be interpreted with caution. We could not provide cost for any specific type of SMI intervention, because in many publications detailed information needed to estimate the intervention cost was missing (for example number of sessions, average group size or duration of sessions). As an alternative, we searched for intervention cost estimates as presented by the authors of publications and used the average value as an estimate of the average costs of SMI programs for HF in general. Further, the costs of the SMI, implementation of SMIs and HF management programs vary between countries and target group. |
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Cost-effectiveness Does the cost-effectiveness of the intervention favor the intervention or the comparison? |
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The table below shows the cost-effectiveness results for the SMI intervention. Costs and QALYs in this analysis were discounted at 3.5% annual rate.
NA: not applicable; QALY: quality adjusted life years; ICER: incremental cost-effectiveness ratio. Explanations
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ADDITIONAL CONSIDERATIONS | |||||||||||||||||||||||||||||
The guideline panel judged that the cost-effectiveness probably favors the intrvention.
There is a possibility that this specific SMI can be cost-effective, but this depends on the intervention costs of the particular intervention and the threshold used. The intervention can cost up to 2,250 euro with a threshold value of 20,000 euro/QALY and 4,546 euro maximum when a threshold value of 50,000 euro/QALY is used. Both cost estimates are above the observed range of cost estimates of SMI in the literature (average 793 euro, range: 65 to 2,045) (see research evidence for an explanation of headroom analysis). Therefore, this specific SMI might be cost-effective at both threshold values of 20,000 and 50,000 euro/QALY. |
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Equity What would be the impact on health equity? |
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In a study on home telemonitoring in Italy, Poland and the UK, a reduction of multiple (two or more) heart failure hospitalizations was observed in Italy when compared with the other two countries (3 vs. 11%, P = 0.02) (Mortara, 2009). However, this analysis was not pre-specified at the beginning of the study and should be considered with caution as a post hoc analysis. |
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ADDITIONAL CONSIDERATIONS | |||||||||||||||||||||||||||||
The panel agreed that the impact on health equity varies, due to the variability across European countries on the levels of health literacy and socioeconomic status. Equity may be affected by geography and accessibility. If implemented, tailored to culture and health literacy, it may increase equity. |
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Acceptability Is the intervention acceptable to key stakeholders? |
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JUDGEMENT | RESEARCH EVIDENCE | ||||||||||||||||||||||||||||
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The information below has been obtained through an overview of systematic reviews of contextual factors, as well as a scoping review and one overview of systematic reviews of values and preferences. It also includes considerations from a Delphi study that was conducted in COMPAR-EU that included the most important contextual factors for the implementation of components (e.g. groups, peers) of self-management interventions according to stakeholders.
References
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ADDITIONAL CONSIDERATIONS | |||||||||||||||||||||||||||||
The guideline panel has judged that this type of SMI is probably acceptable to key stakeholders.
Patients/caregivers: overall acceptable but may vary since it could be influenced by setting, accessibility, tailoring, and other factors.
Healthcare perspective: It could be time and resource consuming.
Healthcare payers’ perspective: Overall acceptable.
Studies' Interventions Kalter-Leibovici-2017 - Disease management, delivered by multi-disciplinary teams, included coordination of care, patient education, monitoring disease symptoms and patient adherence to medication regimen, titration of drug therapy, and home tele-monitoring of body weight, blood pressure and heart rate. - 1 face-to-face session, phone calls and internet-based contacts when needed; all individual - Duration unclear - Expected patient (or carer) self-management behaviours: o Clinical management § Self-monitoring § Medication use and adherence § Early recognition of symptoms o Working with healthcare and/or social care providers § Communication with health care and/or social care provider
Koehler-2010 - Daily remote device monitoring (electrocardiogram, blood pressure, body weight) coupled with medical telephone support - 1 face-to-face session, phone calls and specific device contacts when needed; all individual - Duration unclear - Expected patient (or carer) self-management behaviours: o Clinical management § Condition-specific behaviours § Self-monitoring § Early recognition of symptoms § Asking for professional help or emergency care when needed § Managing devices o Working with healthcare and/or social care providers § Communication with health care and/or social care provider
Mortara-2009 - Home telemonitoring to monitor clinical and physiological parameters - Face-to-face sessions (number unclear), 12 phone calls; all individual - Duration 12 months - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Eating behaviours § Doing physical activity o Clinical management § Self-monitoring § Managing devices
Holland-2007 - Two home visits by one of 17 community pharmacists within two and eight weeks of discharge. Pharmacists reviewed drugs and gave symptom self-management and lifestyle advice. - 2 individual face-to-face sessions - Duration 68 weeks - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Eating behaviours § Doing physical activity § Smoking cessation or reduction o Clinical management § Self-monitoring § Medication use and adherence
Brotons-2009 - Monthly visits to the patients’ home were scheduled for the entire year. In addition, nurses contacted patients by telephone every 15 days to evaluate their clinical status. - 12 face-to-face sessions, 24 phone calls; all individual - Duration 12 months - Expected patient (or carer) self-management behaviours: o Clinical management § Condition-specific behaviours § Medication use and adherence
Deek-2017 - Patients and their family caregivers were provided with a comprehensive, culturally appropriate, educational session on self-care maintenance and symptom management along with self-care resources - Sessions unclear - Duration unclear - Expected patient (or carer) self-management behaviours: o Clinical management § Self-monitoring § Medication use and adherence § Managing devices
Nguyen-2007 - Close follow-up by a nurse-led multidisciplinary team at a maximum of 2 weeks after randomization, then on a monthly basis or more frequently if needed - 7 face-to-face sessions, phone calls when needed; all individual - Duration 6 months - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Eating behaviours § Doing physical activity o Clinical management § Self-monitoring § Medication use and adherence § Early recognition of symptoms
Sadik-2005 - Pharmacist-led pharmaceutical care program - 4 face-to-face sessions, phone calls when needed; all individual - Duration 12 months - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Eating behaviours § Doing physical activity o Clinical management § Self-monitoring § Medication use and adherence § Early recognition of symptoms § Asking for professional help or emergency care when needed § Physical management |
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Feasibility Is the intervention feasible to implement? |
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JUDGEMENT | RESEARCH EVIDENCE | ||||||||||||||||||||||||||||
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The information below has been obtained through an overview of systematic reviews of contextual factors, as well as a scoping review and one overview of systematic reviews of values and preferences. It also includes considerations from a Delphi study that was conducted in COMPAR-EU that included the most important contextual factors for the implementation of components (e.g. groups,peers) of self-management interventions according to stakeholders.
References
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ADDITIONAL CONSIDERATIONS | |||||||||||||||||||||||||||||
The guideline panel judged that the feasibility of implementing this type of SMI varies.
Implementation may be difficult, depending on the context and the use of specific devices for monitoring, for example, online feedback could be more complicated to obtain in certain contexts. and may depend on resources availablity.
Limited human resources, healthcare system coordination and transport services may complicate the implementation of this SMI.
Usually, duration of follow-up was not provided in the studies.
Studies' Interventions Kalter-Leibovici-2017 - Disease management, delivered by multi-disciplinary teams, included coordination of care, patient education, monitoring disease symptoms and patient adherence to medication regimen, titration of drug therapy, and home tele-monitoring of body weight, blood pressure and heart rate. - 1 face-to-face session, phone calls and internet-based contacts when needed; all individual - Duration unclear - Expected patient (or carer) self-management behaviours: o Clinical management § Self-monitoring § Medication use and adherence § Early recognition of symptoms o Working with healthcare and/or social care providers § Communication with health care and/or social care provider
Koehler-2010 - Daily remote device monitoring (electrocardiogram, blood pressure, body weight) coupled with medical telephone support - 1 face-to-face session, phone calls and specific device contacts when needed; all individual - Duration unclear - Expected patient (or carer) self-management behaviours: o Clinical management § Condition-specific behaviours § Self-monitoring § Early recognition of symptoms § Asking for professional help or emergency care when needed § Managing devices o Working with healthcare and/or social care providers § Communication with health care and/or social care provider
Mortara-2009 - Home telemonitoring to monitor clinical and physiological parameters - Face-to-face sessions (number unclear), 12 phone calls; all individual - Duration 12 months - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Eating behaviours § Doing physical activity o Clinical management § Self-monitoring § Managing devices
Holland-2007 - Two home visits by one of 17 community pharmacists within two and eight weeks of discharge. Pharmacists reviewed drugs and gave symptom self-management and lifestyle advice. - 2 individual face-to-face sessions - Duration 68 weeks - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Eating behaviours § Doing physical activity § Smoking cessation or reduction o Clinical management § Self-monitoring § Medication use and adherence
Brotons-2009 - Monthly visits to the patients’ home were scheduled for the entire year. In addition, nurses contacted patients by telephone every 15 days to evaluate their clinical status. - 12 face-to-face sessions, 24 phone calls; all individual - Duration 12 months - Expected patient (or carer) self-management behaviours: o Clinical management § Condition-specific behaviours § Medication use and adherence
Deek-2017 - Patients and their family caregivers were provided with a comprehensive, culturally appropriate, educational session on self-care maintenance and symptom management along with self-care resources - Sessions unclear - Duration unclear - Expected patient (or carer) self-management behaviours: o Clinical management § Self-monitoring § Medication use and adherence § Managing devices
Nguyen-2007 - Close follow-up by a nurse-led multidisciplinary team at a maximum of 2 weeks after randomization, then on a monthly basis or more frequently if needed - 7 face-to-face sessions, phone calls when needed; all individual - Duration 6 months - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Eating behaviours § Doing physical activity o Clinical management § Self-monitoring § Medication use and adherence § Early recognition of symptoms
Sadik-2005 - Pharmacist-led pharmaceutical care program - 4 face-to-face sessions, phone calls when needed; all individual - Duration 12 months - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Eating behaviours § Doing physical activity o Clinical management § Self-monitoring § Medication use and adherence § Early recognition of symptoms § Asking for professional help or emergency care when needed § Physical management |
TYPE OF RECOMMENDATION | ||||
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Strong recommendation against the intervention | Conditional recommendation against the intervention | Conditional recommendation for either the intervention or the comparison | Conditional recommendation for the intervention | Strong recommendation for the intervention |
CONCLUSIONS |
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Recommendation |
For patients with heart failure, the COMPAR-EU heart failure panel, suggests in favour of the use of Education and monitoring techniques rather than usual care (conditional, very low certainty of the evidence about the effects). |
Justification |
The COMPAR-EU heart failure panel made a conditional recommendation in favour of, Education and monitoring techniques, rather than usual care, given a balance that probably favours the intervention (very low quality evidence of effects), the cost-effectiveness evaluation that favours either the intervention or usual care, and an intervention that is probably acceptable for main stakeholders. |
Subgroup considerations |
Effect of the intervention may differ according to the intensity and duration of the intervention. |
Implementation considerations |
When implementing SMI in general, the most important contextual factors to keep in mind are:
When implementing Education the most important contextual factors to keep in mind are:
When implementing monitoring techniques, the most important contextual factors to keep in mind are:
Interaction level:patients’ preference regarding their own role in treatment (for example, the extent to which a patient wants to be involved in shared decision-making, extent to which a patient expects or wants professional involvement in the daily management of their disease). |
Monitoring and evaluation |
Research priorities |
- Future studies should measure patient important outcomes, both critical and important (list below), have adequate sample size and follow-up, including after the intervention is finished. - Future studies should address also preferences and values of patients in relation to their self management, cost effectiveness and sub-categories of self-monitoring interventions. - Future studies should describe in detail the aspects of the intervention and evalute the long term effectiveness. Critical outcomes
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REFERENCES SUMMARY |
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Summary of findings of network meta-analysis
COMPAR-EU Web Isof
Summary of findings of component network meta-analysis
COMPONENT NETWORK META-ANALYSIS (sensitivity analysis)
| Components’ effect (95% Confidence Interval) | CNMA effect (95% Confidence Interval) | |
Outcome | E | MT | |
Adherence to medication | 0.58 (0.25 to 0.91) | 0,71 (0,19 to 1,22) | 1,16 (0,69 to 1,63) |
Knowledge | 0.83 (0.28 to 1.38) | 0.19 (-0.32 to 0.71) | 1,02 (0,52 to 1,53) |
Quality of life | 0.58 (0.25 to 0.91) | 0.05 (-0.25 to 0.35) | 0,63 (0,35 to 0,91) |
Self-efficacy | 0.95 (0. 41 to 1.49) | 0.47 (-0.07 to 1.01) | 1,42 (0,89 to 1,94) |
Components' definition:
E: Education; MT Monitoring techniques
Components
Education (E)
Education (E)
Sharing information. This form of support consists in sharing of information about self-management topics like coping with symptoms, diet, exercise, medication, information about what other people are doing, and information about the disease itself, or about any other relevant aspects that could lead to improved self-management, and ultimately better health. This information can be told or distributed in printed materials like a folder or workbook, or via website or DVD.
Examples: Educational session on healthy eating for people with obesity, provision of a printed leaflet on the importance of foot care in diabetes, or a link to a website with information on chronic obstructive pulmonary disease care.
Monitoring techniques (MT)
Monitoring techniques (MT)
Self-monitoring training and feedback. Training and encouraging people to recognize, monitor, and record behaviours, symptoms, or clinical data. This process may include regular feedback from a clinician, or a synopsis of information registered in a digital tool to encourage you to continue monitoring your illness and behaviours.
Example: Showing a patient how to record blood sugar levels, physical activity, or pain.
Individual sessions
A single person receives the self-management support. Examples: self-guided actions (without the participation of any other person) during a clinical visit or within the context of a support or educational session
Face-to-face
Self-management support delivered in a face-to-face encounter between the providers and patients and/or caregivers.