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We suggest the intervention (Conditional recommendation)
In patients with type-2 diabetes, the COMPAR-EU T2DM panel, suggests in favour of using monitoring techniques and social support delivered remotely rather than usual care
Justification
The COMPAR-EU T2DM panel made a conditional recommendation in favour of the intervention due to a balance that probably favours the intervention.
The panel agreed that the cost-effectiveness relationship that does not favour either the intervention or the comparison, and that the intervention probably increases equity, and is probably acceptable and feasible.
Subgroup considerations
None.
Implementation
When implementing SMI in general, the most important contextual factors to keep in mind are:
- Healthcare providers’ level: it is important to adapt the advice, communication or intervention to patient’s personal situation and level of knowledge; to have adequate communication skills (for example, show empathy, provide understandable information, ask questions);
- Patients’ level: patient’s motivation to engage in self-management; patient’s attitude towards self-management (for example, beliefs about the importance of self-management for health, beliefs about the usefulness of certain self-management tasks).
- 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).
When implementing monitoring techniques, the most important contextual factors to keep in mind are:
- Healthcare providers’ level: it is important to adapt the advice, communication or intervention to patient’s personal situation and level of knowledge; to be aware of your attitude toward the patients’ knowledge and personal beliefs.
- Patients’ level: patient’s motivation to engage in self-management; patient’s attitude towards self-management.
- 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).
When implementing Social support the most important contextual factors to keep in mind are:
- Healthcare providers’ level: it is important to adapt the advice, communication or intervention to patient’s personal situation and level of knowledge; to have expertise in supporting self-management for chronic diseases;
- Patients’ level: (perceived) available support from family and friends; peer support and interaction
When implementing SMI delivered Remotely the most important contextual factors to keep in mind are:
- Healthcare providers’ level: it is important to adapt the advice, communication or intervention to patient’s personal situation and level of knowledge; to have adequate communication skills (for example, show empathy, provide understandable information, ask questions);
- Patients’ level: patient’s motivation to engage in self-management;
- System level: the availability of a suitable infrastructure for self-management support
SoF
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ComparEuEtdsWeb
QUESTION | |
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08. Should monitoring techniques and social support delivered remotely vs. usual care be used for adult patients with type 2 diabetes mellitus (T2DM)? | |
Population | Adult patients with type 2 diabetes mellitus (T2DM) |
Intervention | Monitoring techniques and social support delivered remotely See more |
Comparison | Usual Care |
Main outcomes | Critical outcomes HbA1C Weight management (BMI; waist; weight) Qol (Qol overall; Psychological distress) Hypoglycaemia Blood pressure (SBP; DBP) Long term complications Lipid profile (LDL/triglycerides) Mortality Important outcomes Self-efficacy Self-management (Self-management foot care; Self-management behaviours) Dietary habits (Dietary habits; Fat consumption) Knowledge Physical activity (Physical activity; Steps per day) Self-monitoring glucose Adherence Care satisfaction Lipid profile (HDL; Total cholesterol) * Unscheduled visits/hospitalization |
Setting | European Union, Outpatient care |
Perspective | Clinical recommendation- Population perspective |
Background | Type 2 diabetes mellitus (T2DM) is one of the most prevalent chronic diseases worldwide, with a trend of continuous growth of its incidence and prevalence rates in Europe. Self-management interventions (SMI) for T2DM, like groups based-education programmes, have shown clinically relevant improvements in glycaemic control, T2DM knowledge, triglyceride levels, blood pressure, medication reduction, and self-management (Khunti et al., 2012, Speight J et al., 2010). Also, SMI may improve measures of psychological health, self-efficacy, and of adherence (Umpierre D et al., 2011, Steinsbekk A et al., 2012, de Jongh T et al., 2012, Tricco AC et al., 2012, Deakin T et al., 2005; Odgers-Jewell K et al., 2017). However, there are still gaps in the evidence that include the effect of SMI on micro- and macrovascular complications, to determine the effects of group versus individual-based SMI, the effects of different modes of delivery, and how do different factors (e.g., ethnicity, gender, and comorbidities) influence in the SMI effects (ESC/EASD 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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Type 2 diabetes mellitus (T2DM) is one of the most prevalent chronic diseases worldwide. There are more than 64 million people in the European Region are living with diabetes. Diabetes is also among the leading causes of noncommunicable disease-related deaths in the region and can lead to systemic complications including heart attack and heart failure, stroke, blindness, kidney failure, liver malfunction, loss of limbs and loss of life. Although self-management interventions (SMI) may improve some health outcomes, there are still gaps in the evidence that include the need to determine their long term effect on micro- and macrovascular complications, the effects of the different components (e.g. group versus individual-based SMI, modes of delivery), and how do different contextual factors influence in the SMI effects. |
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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. The panel considered the possibility that the effect of the intervention could differ according to the management in usual care, the HbA1c baseline levels, and duration of the diabetes.
No data available for the rest of critical/important outcomes: Critical outcomes: Hypoglacaemia Long term complications
Important outcomes HDL: 3.87 [-1.96, 9.7] Total cholesterol: -4.25 [-19.94, 11.43] Physical activitiy: 0.53 [-0.46, 1.52]
Component NMA HbA1c: the components with larger effects are education (E), monitoring (MT), emotional-based behavioural techniques (EB), social support (SS), remotly delivered (R). Proportion of direct evidence contributing to the final NMA estimate: -HbA1c: 0% -SBP: 0 % -DBP: 0% -BMI: 0% -Triglycerides: 0% -LDL: 0%
Studies' interventions
McMahon-2012 - internet access and training (‘‘Web training’’) that was directed to a series of diabetes self-management - provision of a laptop computer and Internet access with training in the use of the device as necessary - no care management support - 2 sessions, length unclear (information session and individual computer training)
Tjam-2006 - interactive internet program, consisting of a central data repository that the patient or healthcare provider could access - 1 individual session face-to-face, length unclear - internet-based sessions when needed - duration 6 months
Component NMA HbA1c: the components with larger effects are education (E), monitoring techniques (MT) and social support (SS), remotly delivered (R).
Modeling estimations for long term consequences We used the COMPAR-EU model developed for the cost-effectiveness analysis to also inform about long-term health outcomes. Decision analysis models estimate 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 effect on HBA1C, LDL/HLD cholesterol, and BMI from the NMA.
We suggest cautious interpretation as the certainty of the evidence for those input parameters was low to very low across comparisons.
- Life-Years (LY): 4.02 days of additional life per person - Quality-Adjusted Life Years (QALY): 2.95 days of additional full health life per person - Heart failure: 0.31 more events per 1,000 persons - Myocardial infarction: 0,80 fewer events per 1,000 persons - Stroke: 0.43 fewer events per 1,000 persons -Blindness: 0.67 fewer events per 1,000 persons -Renal failure: 0. fewer/more events per 1,000 persons -Amputations: 0.46 fewer events per 1,000 persons. |
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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 no effect, or causing no harmful effects except for the potential associated burden of the intervention. |
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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 low, being HbA1c the most relevant outcomes and the certainty of that evidence being low. |
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Values Is there important uncertainty about or variability in how much people value the main outcomes? |
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JUDGEMENT | RESEARCH EVIDENCE | |||||||||||||||||||||
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An overview of systematic reviews [Niño de Guzman et al. 2021, pending to publish] provided information about how patients value several of the outcomes of interest (critical/important) included in this clinical question:
Abbreviations: CI: confidence interval, EQ5D: EuroQol-5D Utility values findings were assessed using the GRADE approach guidance (Zang 2019), and for findings assessing the burden for patients, we applied the CERQual approach (https://www.cerqual.org/) 1: Serious risk of indirectness (findings derived from a Japanese population) and imprecision (wide range of values reported). Moderate concerns in the adequacy of findings (scarce and thin data) 2:Serious concerns in the adequacy of findings (scarce and thin data) 3: Serious risk of indirectness regarding how the outcome was assessed, in studies of utility values, exploring the final state of having a specific BMI, and only some studies explored the weight change as BMI excess over 25, reporting it as the value per unit of excess. Moderate concerns in the relevance of findings referred explicitly to adherence to medication (insulin and others) that can be integrated into SM treatment but were not collected from patients who explicitly participated in SM interventions. 4: Serious indirectness due to variable methods applied for collecting health utilities. Serious concerns in adequacy of findings since we identified scarce qualitative evidence for other long term complications. Moreover, moderate concerns regarding relevance of findings, some findings may not represent the majority of patients. 5:Moderate concerns in relevance of findings, some findings might reflect systematic reviews author’s points of view
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ADDITIONAL CONSIDERATIONS | ||||||||||||||||||||||
The guideline panel judged that there is no important uncertainty or variability of how patients value the main outcomes.
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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 favorus the intervention. This is due to the small desirable effects, the trivial undesirable effects, and the lack of uncertainty and variability of how patients value outcomes, as well as the low certainty of evidence of effects |
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Resources required How large are the resource requirements (costs)? |
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Available data on resource use: The two studies providing information for this intervention (Mcmahon 2012 & Tjam 2006) lacked sufficient information on resource use.
Cost estimates for other self management interventions for type 2 diabetes: A previously published review of the resource use and costs for self management interventions for type 2 diabetes (Lian et al., 2017) found that such costs vary strongly between interventions, depending both on the design of the intervention and the costing perspective (i.e. which cost items are taken into account). We combined data from this review with the data from all papers in the COMPAR-EU database reporting on the cost of interventions. Published costs for self management interventions for type 2 diabetes range from 3.90 EUR to 3747 EUR per patient, with a mean of 853 EUR and median of 324 EUR per patient |
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ADDITIONAL CONSIDERATIONS | ||||||||||||||||||||||
Because of the lack of information, the guideline panel agreed on a Don't know judgmenet about the resources required for this SMI.
The publications on the studies underlying this node of the NMA did not provide enough information to make any judgement on the resource use required.
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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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No study on resource use was available |
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Cost-effectiveness Does the cost-effectiveness of the intervention favor the intervention or the comparison? |
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JUDGEMENT | RESEARCH EVIDENCE | |||||||||||||||||||||
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Available data on resource use: The two studies providing information for this intervention (Mcmahon 2012 & Tjam 2006) lacked sufficient information on resources.
Abbreviations: NA: non applicable; QALY: quality adjusted life years; ICER: incremental cost-effectiveness ratio; GBP: Great British Pound; EUR: Euros Explanations: a. The model used the following input parameters from the NMA: FEV1% predicted, exacerbations and symptoms b. Inconsistency: the costing 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.
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ADDITIONAL CONSIDERATIONS | ||||||||||||||||||||||
The guideline panel judged that the cost-effectiveness does not favor either the intervention or the comparison.
Whether this intervention is cost-effective strongly depends on the cost for which the intervention can be provided to participants. This, in turn, strongly depends on the exact implementation of the intervention, such as the duration and intensity. It should be noted that the headroom estimate for this intervention is lower than the mean and median cost of self management interventions as published in literature. Therefore, there is a considerable probability that the cost of the intervention is actually higher than the headroom, meaning that the intervention would not be cost-effective.
The estimated headroom is close to the estimated costs of the intervention. Given the large uncertainty around both estimates, we are unable to say whether these interventions will be cost-effective or not given the current evidence.
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Equity What would be the impact on health equity? |
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No specific systematic review was conducted to inform this domain. |
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ADDITIONAL CONSIDERATIONS | ||||||||||||||||||||||
The panel agreed that if implemented tailored to culture and health literacy it could increase equity. Equity might be affected by geography and accessibility. Equity might be affected by access to mobile technology.
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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.
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ADDITIONAL CONSIDERATIONS | ||||||||||||||||||||||
The guideline panel 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.
Studies' interventions McMahon-2012:
Tjam-2006:
o Lifestyle related behaviours § Eating behaviours § Doing physical activity o Clinical management § Condition-specific behaviours § Self-monitoring § Medication use and adherence § 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.
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ADDITIONAL CONSIDERATIONS | ||||||||||||||||||||||
The guideline panel judged that this type of SMI is probably feasible. Limited human resources may complicate the implementation of this intervention
Studies' interventions McMahon-2012:
Tjam-2006:
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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 type-2 diabetes, the COMPAR-EU T2DM panel, suggests in favour of using monitoring techniques and social support delivered remotely , rather than usual care (conditional, low certainty of the evidence about the effects). |
Justification |
The COMPAR-EU T2DM panel made a conditional recommendation in favour of the intervention due to a balance that probably favours the intervention. The panel agreed that the cost-effectiveness relationship that does not favour either the intervention or the comparison, and that the intervention probably increases equity, and is probably acceptable and feasible. |
Subgroup considerations |
None. |
Implementation considerations |
When implementing SMI in general, the most important contextual factors to keep in mind are:
When implementing monitoring techniques, the most important contextual factors to keep in mind are:
When implementing Social support the most important contextual factors to keep in mind are:
When implementing SMI delivered Remotely the most important contextual factors to keep in mind are:
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Monitoring and evaluation |
No suggestion |
Research priorities |
- Future studies should prioritise measuring patient outcomes, both critical and important (see list of outcomes included in COMPAR-EU core outcome set below), have adequate sample size and follow-up, including after the intervention is finished. - Feasibility of the interventions should also be assessed. - Populations should include both patients with different levels of health literacy. - Future studies shpuld include long term effects of these interventions - Future studies shpuld also assess other psychosocial outcomes (Diabetes distress levels, patient activation to measure engagement with care, psychological wellbeing, social support).
List of outcomes included in COMPAR-EU core outcome set Critical outcomes
Important outcomes
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REFERENCES SUMMARY |
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1. World Health Organization, WHO. Registries and information systems for diabetes care in the WHO European Region: preliminary findings for consultation. 2021. 2. Francesco Cosentino, Peter J Grant,Victor Aboyans,Clifford J Bailey,Antonio Ceriello,Victoria Delgado,Massimo Federici,Gerasimos Filippatos,Diederick E Grobbee,Tina Birgitte Hansen,Heikki V Huikuri,Isabelle Johansson,Peter Jüni,Maddalena Lettino,Nikolaus Marx,Linda G Mellbin,Carl J Östgren,Bianca Rocca,Marco Roffi,Naveed Sattar,Petar M Seferović,Miguel Sousa-Uva,Paul Valensi,David C Wheeler,ESC Scientific Document Group. 2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD: The Task Force for diabetes, pre-diabetes, and cardiovascular diseases of the European Society of Cardiology (ESC) and the European Association for the Study of Diabetes (EASD). European Heart Journal; 2020. 3. Trikalinos TA, Siebert U,Lau J. ecision-Analytic Modeling to Evaluate Benefits and Harms of Medical Tests—Uses and Limitations. 2009 Nov 9. In: Medical Tests-White Paper Series [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2009-. 2009. 4. von Arx, L. B., Kjeer, T.. The patient perspective of diabetes care: a systematic review of stated preference research. Patient; 2014. 5. Ho, A. Y., Berggren, I., Dahlborg-Lyckhage, E.. Diabetes empowerment related to Pender's Health Promotion Model: a meta-synthesis. Nurs Health Sci; Jun 2010. 6. Janssen, M. F., Lubetkin, E. I., Sekhobo, J. P., Pickard, A. S.. The use of the EQ-5D preference-based health status measure in adults with Type 2 diabetes mellitus. Diabet Med; Apr 2011. 7. Nam, S., Chesla, C., Stotts, N. A., Kroon, L., Janson, S. L.. Barriers to diabetes management: patient and provider factors. Diabetes Res Clin Pract; Jul 2011. 8. Beaudet, A., Clegg, J., Thuresson, P. O., Lloyd, A., McEwan, P.. Review of utility values for economic modeling in type 2 diabetes. Value Health; Jun 2014. 9. Ellis, K., Mulnier, H., Forbes, A.. Perceptions of insulin use in type 2 diabetes in primary care: a thematic synthesis. BMC Fam Pract; May 22 2018. 10. Polinski, J. M., Smith, B. F., Curtis, B. H., Seeger, J. D., Choudhry, N. K., Connolly, J. G., Shrank, W. H.. Barriers to insulin progression among patients with type 2 diabetes: a systematic review. Diabetes Educ; Jan-Feb 2013. 11. Psarou, A., Cooper, H., Wilding, J. P. H.. Patients' Perspectives of Oral and Injectable Type 2 Diabetes Medicines, Their Body Weight and Medicine-Taking Behavior in the UK: A Systematic Review and Meta-Ethnography. Diabetes Ther; Oct 2018. 12. Alleman, C. J., Westerhout, K. Y., Hensen, M., Chambers, C., Stoker, M., Long, S., van Nooten, F. E.. Humanistic and economic burden of painful diabetic peripheral neuropathy in Europe: A review of the literature. Diabetes Res Clin Pract; Aug 2015. 13. Lung, T. W., Hayes, A. J., Hayen, A., Farmer, A., Clarke, P. M.. A meta-analysis of health state valuations for people with diabetes: explaining the variation across methods and implications for economic evaluation. Qual Life Res; Dec 2011.
14. Poku, E., Brazier, J., Carlton, J., Ferreira, A.. Health state utilities in patients with diabetic retinopathy, diabetic macular oedema and age-related macular degeneration: a systematic review. BMC Ophthalmol; Dec 4 2013. 15. Coffey, L., Mahon, C., Gallagher, P.. Perceptions and experiences of diabetic foot ulceration and foot care in people with diabetes: A qualitative meta-synthesis. Int Wound J; Feb 2019. 16. Rouyard, T., Kent, S., Baskerville, R., Leal, J., Gray, A.. Perceptions of risks for diabetes-related complications in Type 2 diabetes populations: a systematic review. Diabet Med; Apr 2017. 17. Zhang, Y., Alonso-Coello, P., Guyatt, G. H., Yepes-Nunez, J. J., Akl, E. A., Hazlewood, G., Pardo-Hernandez, H., Etxeandia-Ikobaltzeta, I., Qaseem, A., Williams, J. W.,Jr., Tugwell, P., Flottorp, S., Chang, Y., Zhang, Y., Mustafa, R. A., Rojas, M. X., Schunemann, H. J.. GRADE Guidelines: 19. Assessing the certainty of evidence in the importance of outcomes or values and preferences-Risk of bias and indirectness. J Clin Epidemiol; Jul 2019. 18. Zhang, Y., Coello, P. A., Guyatt, G. H., Yepes-Nunez, J. J., Akl, E. A., Hazlewood, G., Pardo-Hernandez, H., Etxeandia-Ikobaltzeta, I., Qaseem, A., Williams, J. W.,Jr., Tugwell, P., Flottorp, S., Chang, Y., Zhang, Y., Mustafa, R. A., Rojas, M. X., Xie, F., Schunemann, H. J.. GRADE guidelines: 20. Assessing the certainty of evidence in the importance of outcomes or values and preferences-inconsistency, imprecision, and other domains. J Clin Epidemiol; Jul 2019. |
Summary of findings of network meta-analysis
COMPAR-EU Isof Web
Summary of findings of component network meta-analysis
Component network meta-analysis model (sensitivity analysis)
Outcomes | Components’ effect (95% Confidence Interval) | CNMA effect (95% Confidence Interval) | |||
E | MT | SS |
R | ||
Hb1Ac | -0,2543 (-0,3444 to -0,1643) | -0,1439 (-0,2242 to -0,0637) | -0,0644 (-0,1618 to 0,0331) | -0,0157 (-0,1136 to 0,0822) | -0,5276 (-0,6634 to -0,3917) |
Components' definition:
E: Education; MT: Monitoring techniques; SS Social support; R: remotly delivered
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.
Social support (SS)
Social support (SS)
Helping you to think through how you could obtain social support from others to help them achieve behavioural or outcome goals. It could also include the actual provision of social support or discussions about social support networks suited to your preferences, needs, disease burden, or additional life burdens. Part of this support would include linking you to relevant community services to enhance socialization and make the most of support mechanisms in the local community.
Examples: Encouraging family members to become involved in helping you to manage your disease or encouraging you to participate in a local exercise group.
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
Remote
When patients (and/or caregivers) are not in the same place as the health care providers. This interaction can take place through different communication means or tools (e.g., telephone, smartphone, Internet).
Weight (management) | Blood-pressure | Lipid profile | HbA1C | |
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Monitoring techniques and social support delivered remotely | ||||
See practical considerations |
Evidence table description for recommendations section
To enter the decision aids section please press "start".
Practical considerations
Research priorities
- Future studies should prioritise measuring patient outcomes, both critical and important (see list of outcomes included in COMPAR-EU core outcome set below), have adequate sample size and follow-up, including after the intervention is finished.
- Feasibility of the interventions should also be assessed.
- Populations should include both patients with different levels of health literacy.
- Future studies shpuld include long term effects of these interventions
- Future studies shpuld also assess other psychosocial outcomes (Diabetes distress levels, patient activation to measure engagement with care, psychological wellbeing, social support).
List of outcomes included in COMPAR-EU core outcome set
Critical outcomes
- HbA1C
- Weight management (BMI; waist; weight)
- Qol (Qol overall; Psychological distress)
- Hypoglycaemia
- Blood pressure (SBP; DBP)
- Long term complications
- Lipid profile (LDL/triglycerides)
- Mortality
Important outcomes
- Self-efficacy
- Self-management (Self-management foot care; Self-management behaviours)
- Dietary habits (Dietary habits; Fat consumption)
- Knowledge
- Physical activity (Physical activity; Steps per day)
- Self-monitoring glucose
- Adherence
- Care satisfaction
- Lipid profile (HDL; Total cholesterol)
- Unscheduled visits/hospitalization
Background
Type 2 diabetes mellitus (T2DM) is one of the most prevalent chronic diseases worldwide, with a trend of continuous growth of its incidence and prevalence rates in Europe. Self-management interventions (SMI) for T2DM, like groups based-education programmes, have shown clinically relevant improvements in glycaemic control, T2DM knowledge, triglyceride levels, blood pressure, medication reduction, and self-management (Khunti et al., 2012, Speight J et al., 2010). Also, SMI may improve measures of psychological health, self-efficacy, and of adherence (Umpierre D et al., 2011, Steinsbekk A et al., 2012, de Jongh T et al., 2012, Tricco AC et al., 2012, Deakin T et al., 2005; Odgers-Jewell K et al., 2017). However, there are still gaps in the evidence that include the effect of SMI on micro- and macrovascular complications, to determine the effects of group versus individual-based SMI, the effects of different modes of delivery, and how do different factors (e.g., ethnicity, gender, and comorbidities) influence in the SMI effects (ESC/EASD 2019)