Fil d'Ariane
ComparEuEtdsWeb
QUESTION | |
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1.Should education and monitoring techniques vs. usual care be used for adult patients living with COPD? | |
Population | Adult patients living with COPD |
Intervention | Monitoring techniques See more |
Comparison | Usual Care |
Main outcomes | Dyspnea; Anxiety; Depression; ER (all cause); Exacerbations; Mortality; Quality of life (generic); QoL (specific); Smoking cessation; Activities of daily life (generic); |
Setting | European Union, outpatient care |
Perspective | Clinical recommendation- Population perspective |
Background | Chronic Obstructive Pulmonary Disease (COPD) is one of the major causes of morbidity and mortality worldwide. The economic and social burden related to COPD are expected to increase over the coming decades due to the continued exposure to COPD risk factors and the increasing aging of the world’s population. COPD prevalence varies across countries and across different groups within countries (i.e., being male, older and former or current smoker). It is directly related to the prevalence of tobacco smoking, although in many countries out-door and indoor air pollution constitute major risk factors. |
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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Chronic Obstructive Pulmonary Disease (COPD) is one of the major causes of morbidity and mortality worldwide [1,2]. The economic and social burden related to COPD are expected to increase over the coming decades due to the continued exposure to COPD risk factors and the increasing aging of the world’s population [3]. COPD prevalence varies across countries and across different groups within countries (i.e., being male, older and former or current smoker) [4]. It is directly related to the prevalence of tobacco smoking, although in many countries out- door and indoor air pollution constitute major risk factors [5,6].
References: 1. Lozano R, Naghavi M, Foreman K, Lim S, Shibuya K, Aboyans V, et al. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Bur- den of Disease Study 2010. Lancet. 2012 Dec; 380(9859):2095–128. https://doi.org/10.1016/S0140- 6736(12)61728-0 PMID: 23245604 2. Vos T, Flaxman AD, Naghavi M, Lozano R, Michaud C, Ezzati M, et al. Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990–2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012 Dec; 380(9859):2163–96. https://doi.org/10.1016/S0140- 6736(12)61729-2 PMID: 23245607 3. Mathers CD, Loncar D. Projections of Global Mortality and Burden of Disease from 2002 to 2030. Samet J, editor. PLoS Med. 2006 Nov 28; 3(11):e442. https://doi.org/10.1371/journal.pmed.0030442 PMID: 17132052 4. Whitmore G, Aaron S, Gershon A, Gao Y, Yang J. Influence of country-level differences on COPD prev- alence. Int J Chron Obstruct Pulmon Dis. 2016 Sep; Volume 11:2305–13. https://doi.org/10.2147/ COPD.S113868 PMID: 27698561 5. Eisner MD, Anthonisen N, Coultas D, Kuenzli N, Perez-Padilla R, Postma D, et al. An Official American Thoracic Society Public Policy Statement: Novel Risk Factors and the Global Burden of Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2010 Sep; 182(5):693–718. https://doi. org/10.1164/rccm.200811-1757ST PMID: 20802169 6. Salvi SS, Barnes PJ. Chronic obstructive pulmonary disease in non-smokers. Lancet. 2009 Aug; 374 (9691):733–43. https://doi.org/10.1016/S0140-6736(09)61303-9 PMID: 19716966 |
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ADDITIONAL CONSIDERATIONS | ||||||||||||||||||||||||||
Note: The more serious a problem is, the more likely it is that an intervention (option) that addresses the problem should be a priority or should be recommended (if it helps). |
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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 small due to the effect on dyspnea, activities of daily life, quality of life and smoking cessation, as well as, the little to no effect in other critical outcomes (including mortality and exacerbations). The panel considered the possibilty that the effect of the intervention could differ according to the intensity of the monitoring and duration of the intervention.
No data available for the rest of critical/important outcomes.
Proportion of direct evidence contributing to the final NMA estimate per outcome: - Dyspnoea: 39% - Anxiety: 100% - Depression: 100% - Emergency room visits: 100% - Mortality: 96% - QoL (generic): 87% - QoL (specific): 60% - Smoking cessation: 100% (pairwise meta-analysis) - Activities of daily life: 100% (pairwise meta-analysis)
Component Network Meta-analysis Components with largest contribution: Dyspnea: Education (E) component. Quality of life: Education (E) and monitoring techniques (MT) component.
Haesum-2017: - Telehomecare solution comprising a tablet, a Digital Blood Pressure Monitor, a Health Scale and an attached Fingertip Pulse Oximeter; instructions from nurse - 2 individual face-to-face sessions, phone calls when needed - Duration 12 months - 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
Bucknall-2012: - Training sessions by nurse to detect and treat exacerbations promptly - Four 40 minute individual training sessions at home; further home visits at least every six weeks - Duration 12 months - Expected patient (or carer) self-management behaviours: o Clinical management § Condition-specific behaviours § Self-monitoring § Medication use and adherence § Early recognition of symptoms
Xin-2016: - Structured education about COPD was by a clinical pharmacist at a pharmacist-managed clinic - Individual face-to-face sessions (number, length and frequency unclear); phone calls and internet-based contacts when needed - Duration 12 months - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Eating behaviours § Smoking cessation or reduction o Clinical management § Condition-specific behaviours § Medication use and adherence
Soriano-2018: - specific monitoring protocol with telehealth - 1 individual face-to face session (length unclear); phone calls when needed - Duration 12 months - Expected patient (or carer) self-management behaviours: o Clinical management § Condition-specific behaviours § Self-monitoring § Medication use and adherence § Early recognition of symptoms § Managing devices
Nguyen-2013: - Dyspnea self-management program focusing on education, skills training, and coaching on dyspnea self-management strategies, including exercise - Individual, 2-hour face-to-face sessions (number and frequency unclear) - Duration 12 months - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Doing physical activity o Clinical management § Condition-specific behaviours § Self-monitoring
Chan-2016: - Tablet-based instruction of breathing technique - 3 face-to-face sessions (25 minutes, groups and individual), frequency unclear - Duration unclear - Expected patient (or carer) self-management behaviours: o Clinical management § Condition-specific behaviours
Chau-2012: - Telecare device kit including a specially designed mobile phone, a respiratory rate sensor, and a pulse oximeter; home visits by community nurse - Individual face-to-face sessions (number, length and frequency unclear) - Duration 8 weeks - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Eating behaviours § Doing physical activity o Clinical management § Condition-specific behaviours § Self-monitoring § Medication use and adherence § Asking for professional help or emergency care when needed § Managing devices
Shany-2017: - Home telemonitoring of oximetry, temperature, pulse, electrocardiogram, blood pressure, spirometry, and weight with telephone support and home visits by respiratory community nurse - Individual face-to-face sessions and phone calls when needed - Duration 12 months - 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
Modeling estimations for long term consequences We used the COMPAR-EU COPD 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 lung function (FEV1% predicted), exacerbations and symptoms. 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): 18 days of additional life per patient - Total exacerbations: average reduction of 0.40 per patient over lifetime - Severe exacerbations (defined as hospitalization): average reduction of 0.05 per patient over lifetime |
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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, or causing no undesirable effects, except for the potential associated burden of the intervention.
The panel agreed that the burden could vary according to the intensity of monitoring.
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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 judged the certainty of 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:
CERQUAL (assessing 3 domains Coherence, Relevance, Adequacy) and GRADE Abbreviations:
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ADDITIONAL CONSIDERATIONS | ||||||||||||||||||||||||||
The guideline panel judged that there is probably no important uncertainty or variability 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 small 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 972 euros per patient, with a range from 53 to 2921 euros.
Please note that this average/range estimate has been based on ten cost estimates of SMIs for COPD reported in publications.
Model analyses showed that over lifetime the total costs (without cost of the intervention) for the SMI were 529 euros higher compared to usual care. This cost increase was mainly the result of an increased life-expectancy with additional costs in the life-years gained.
References:
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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 COPD 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 COPD in general.
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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 a.The model used the following input parameters from the NMA: FEV1% predicted, exacerbations and symptoms b. Inconsistency: the cost analysis for the intervention showed inconsistent measurements which precluded us from providing specific interventions costs. c. For the headroom analysis a threshold of 20,000 Euro or 50,000 Euro per QALY was used to consider an intervention to be cost-effective.
Headroom Analyses: Headroom analysis is an alternative to conducting a full cost-effectiveness analysis. This is a threshold approach, which determines the maximum amount that could be spent on an intervention to still be regarded as cost-effective, also known as the maximum reimbursable price (MRP) (Girling, Lilford, Cole, & Young, 2015) At a 20,000 euro per QALY threshold, the resulting headroom estimate is: References:
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ADDITIONAL CONSIDERATIONS | ||||||||||||||||||||||||||
The guideline panel judged that the cost-effectiveness does not favor either the intervention or the comparison.
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 may cost 602 euro maximum (headroom estimate) when a threshold value of 20,000 euro/QALY is used and 2,299 euro maximum when a threshold value of 50,000 euro/QALY is used. Both cost estimates are within the observed range of cost estimates of SMI in the literature (average 972 euro, range: 53 to 2,921) (see below for an explanation of headroom analysis). |
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Equity What would be the impact on health equity? |
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No specific systematic review was conducted for this domain |
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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. (drop-out varies 0-20%)
Healthcare perspective: It could be time and resource consuming.
Healthcare payers’ perspective: Overall acceptable.
Studies' Interventions (NMA) If nodes contain a large number of studies, these below are selected using the following criteria: 1. variation in countries; 2. largest sample sizes; 3. variation in severity; 4. most recent years of publication.
Chan-2016: - Tablet-based instruction of breathing technique - 3 face-to-face sessions (25 minutes, groups and individual), frequency unclear - Duration unclear - Expected patient (or carer) self-management behaviours: o Clinical management § Condition-specific behaviours
Chau-2012: - Telecare device kit including a specially designed mobile phone, a respiratory rate sensor, and a pulse oximeter; home visits by community nurse - Individual face-to-face sessions (number, length and frequency unclear) - Duration 8 weeks - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Eating behaviours § Doing physical activity o Clinical management § Condition-specific behaviours § Self-monitoring § Medication use and adherence § Asking for professional help or emergency care when needed § Managing devices
Haesum-2017: - Telehomecare solution comprising a tablet, a Digital Blood Pressure Monitor, a Health Scale and an attached Fingertip Pulse Oximeter; instructions from nurse - 2 individual face-to-face sessions, phone calls when needed - Duration 12 months - 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
Shany-2017: - Home telemonitoring of oximetry, temperature, pulse, electrocardiogram, blood pressure, spirometry, and weight with telephone support and home visits by respiratory community nurse - Individual face-to-face sessions and phone calls when needed - Duration 12 months - 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
Soriano-2018: - specific monitoring protocol with telehealth - 1 individual face-to face session (length unclear); phone calls when needed - Duration 12 months - Expected patient (or carer) self-management behaviours: o Clinical management § Condition-specific behaviours § Self-monitoring § Medication use and adherence § Early recognition of symptoms § Managing devices |
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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 (NMA) If nodes contain a large number of studies, these below are selected using the following criteria: 1. variation in countries; 2. largest sample sizes; 3. variation in severity; 4. most recent years of publication.
Bucknall-2012: - Training sessions by nurse to detect and treat exacerbations promptly - Four 40 minute individual training sessions at home; further home visits at least every six weeks - Duration 12 months - Expected patient (or carer) self-management behaviours: o Clinical management § Condition-specific behaviours § Self-monitoring § Medication use and adherence § Early recognition of symptoms
Soriano-2018: - specific monitoring protocol with telehealth - 1 individual face-to face session (length unclear); phone calls when needed - Duration 12 months - Expected patient (or carer) self-management behaviours: o Clinical management § Condition-specific behaviours § Self-monitoring § Medication use and adherence § Early recognition of symptoms § Managing devices
Xin-2016: - Structured education about COPD was by a clinical pharmacist at a pharmacist-managed clinic - Individual face-to-face sessions (number, length and frequency unclear); phone calls and internet-based contacts when needed - Duration 12 months - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Eating behaviours § Smoking cessation or reduction o Clinical management § Condition-specific behaviours § Medication use and adherence
Nguyen-2013: - Dyspnea self-management program focusing on education, skills training, and coaching on dyspnea self-management strategies, including exercise - Individual, 2-hour face-to-face sessions (number and frequency unclear) - Duration 12 months - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Doing physical activity o Clinical management § Condition-specific behaviours § Self-monitoring
Haesum-2017: - Telehomecare solution comprising a tablet, a Digital Blood Pressure Monitor, a Health Scale and an attached Fingertip Pulse Oximeter; instructions from nurse - 2 individual face-to-face sessions, phone calls when needed - Duration 12 months - 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
Shany-2017: - Home telemonitoring of oximetry, temperature, pulse, electrocardiogram, blood pressure, spirometry, and weight with telephone support and home visits by respiratory community nurse - Individual face-to-face sessions and phone calls when needed - Duration 12 months - 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
Chau-2012: - Telecare device kit including a specially designed mobile phone, a respiratory rate sensor, and a pulse oximeter; home visits by community nurse - Individual face-to-face sessions (number, length and frequency unclear) - Duration 8 weeks
Chan-2016: - Tablet-based instruction of breathing technique - 3 face-to-face sessions (25 minutes, groups and individual), frequency unclear - Duration unclear - Expected patient (or carer) self-management behaviours: o Clinical management § Condition-specific behaviours |
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 |
In patients with COPD, the COMPAR-EU COPD panel, suggests in favour of the use of Education and monitoring techniques, rather than usual care (conditional, due to very low certainty of the evidence about the effects). |
Justification |
The COMPAR-EU COPD 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 neither the intervention nor usual care, and an intervention that is probably acceptable for main stakeholders. |
Subgroup considerations |
Effect of the intervention may differ according to the intensity of the intervention 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:
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Monitoring and evaluation |
No suggestions |
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 be patient specific from a person-centred care perspective.
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REFERENCES SUMMARY |
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Summary of findings of network meta-analysis
Isof web COMPAR-EU
Summary of findings of component network meta-analysis
COMPONENT NETWORK META-ANALYSIS (sensitivity analysis)
| Components's effect (95% Confidence Interval) | CNMA effect (95% Confidence Interval) | |
Outcome | E | MT | |
Dyspnoea | - 0,84 (-1.12 to -0.49) | - 0,15 (-0.51 to 0.19) | - 0,99 (-1.40 to -0.58) |
Quality of life (specific) | - 0,47 (-0.73 to -0.21) | - 0,07 (-0.34 to -0.21) | - 0,54 (-0.82 to -0.27) |
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.