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We suggest the intervention (Conditional recommendation)
In patients with Obesity, the COMPAR-EU Obesity panel, suggests the use of monitoring techniques, rather than usual care
Justification
The COMPAR-EU Obesity panel made a conditional recommendation in favour of Monitoring techniques, rather than usual care alone, due to a probably favourable balance of effects and cost-effectiveness that does not favour either the intervention or the comparison.
Subgroup considerations
None.
Implementation
- It should consider the patient specific factors such as medical history and current psychosocial situation, Local factors and HCP skills
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 Education 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 cognitive and behavioural skills to self-management.
SoF
EtD
ComparEuEtdsWeb
| QUESTION | |
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| 4. Should monitoring techniques vs. usual care be used for adult patients living with obesity? | |
| Population | adult patients living with obesity |
| Intervention | Monitoring techniques See more |
| Comparison | Usual Care |
| Main outcomes | Blood Pressure - Diastolic Blood Pressure; Blood pressure - Systolic Blood Pressure; Weight management- BMI; Weight management- Body fat; Weight management - waist; Quality of life; Depression; Eating self-efficacy; Self-efficacy; Fiber consumption; Total steps; Dietary habits; Consumption of fat; Carbohydrates; Physical activity; Fruit and vegetable consumption; Weight management- Weight; |
| Setting | European Union, outpatient care |
| Perspective | Clinical recommendation- Population perspective |
| Background | Overweight and obesity are chronic metabolic diseases considered as a global public health problem, highly prevalent among adult population (i.e., ̴40%). Obesity increases the risk for many other diseases like diabetes, hypertension, and cancer, thus is a leading cause of disability and death. Some self-management interventions, as behavioural-based weight-loss interventions, have shown more weight loss than usual care and a decreased risk of developing diabetes. However, other health outcomes and long-term effects have been less well reported. Also, the association between weight loss and other health outcomes is still not clear. |
| 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. |
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| Priority of problem Is the problem a priority? |
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| Desirable Effects How substantial are the desirable anticipated effects? |
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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 | ||||||||||||||||||||||||||||
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The guideline panel has judged the desirable effects as moderate
Important outcomes: Fiber consumption(SMD): 0.0351 SD lower (0.4597 lower to 0.3895 higher) Total steps (MD): 1262 steps more (2131.84 fewer to 4655.84 more) Dietary habits (SMD): 0.3953 SD lower (0.9675 lower to 0.1768 higher) Consumption of fat (SMD): 0.1818 SD lower (0.4721 lower to 0.1085 higher) Carbohydrates (SMD): 0.1818 SD lower (0.4721 lower to 0.1085 higher) Physical activity (SMD): 0.6439 SD higher (0.2372 lower to 1.5251 higher) Fruit and vegetable consumption (SMD): 0.0629 SD lower (0.5791 lower to 0.4533 higher)
Proportion of direct evidence contributing to the final NMA estimate per outcome: - Self-efficacy: 100% - Eating self-efficacy: x% - Depression: 0% - DBP: 55% - SBP: 54% - BMI: 49% - Body fat: 18% - Waist size: 55% - Weight: 41% - QoL: 100%
Studies' intervention Logue-2005 - Dietary and exercise advice, prescriptions, and three 24-hour dietary recalls every 6 months - 4 individual face-to-face sessions - Duration 24 months - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Eating behaviours § Doing physical activity o Clinical management § Self-monitoring § Physical management
Kliemann-2017 - A leaflet containing ten tips for weight loss and healthy habits formation, a self-monitoring log book and a wallet-sized shopping guide on how to read food labels - 1 individual face-to-face session - Duration 3 months - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Eating behaviours § Doing physical activity o Clinical management § Self-monitoring
Austel-2015 - Modified Mediterranean-type diet using fat modification - 12-week self-help modified Mediterranean-type diet, 6 weeks of diet plans and 6 weeks of weight loss maintenance training - 12 individual face-to-face sessions - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Eating behaviours o Clinical management § Self-monitoring § Physical management
Jamal-2016 - Dietary counseling sessions - 2 individual face-to-face sessions, once every 12 weeks - Duration 6 months - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Eating behaviours § Doing physical activity
Alcantara-Aragon – 2018 - Tailored exercise and dietary prescriptions based on a Mediterranean dietary pattern, food intake logged on paper - 7 individual face-to-face contacts - Duration 6 months - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Eating behaviours § Doing physical activity o Clinical management § Self-monitoring
Cayir-2015 - Pedometers as a motivational technique - 6 individual face-to-face sessions - Duration 3 months - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Doing physical activity
Jane-2017 - Weight management program delivered by a booklet - 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 § Managing devices
Bergman-2018 - Treadmill workstations that enable office workers to walk on a treadmill while working at their computers - 1 face-to-face session, 4 internet-based sessions when needed; all individual - Duration 13 months - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Doing physical activity o Clinical management § Self-monitoring § Managing devices o Social management § Fitting in at work
Component Network Meta-analysis: Depression: the components with larger effects are education (E) and monitoring techniques (MT) Eating self-efficacy: the components with larger effects is monitoring techniques (MT)
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 each SMIs over BMI from the NMA (see below). We suggest cautious interpretation as the certainty of the evidence for those input parameters was low to very low across comparisons.
- Life-Years (LY): 57 days of additional life per person - Years with diabetes: 74 fewer days per person - Quality-Adjusted Life Years (QALY): 59 days of additional life equivalent to full health per person (undiscounted) - Diabetes mellitus: 9 fewer events per 1,000 persons - Myocardial infarction: 4 fewer events per 1,000 persons - Stroke: 4 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 observed effects. |
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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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The guideline panel judged the certainty of evidence as very 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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An overview of systematic reviews 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 a 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). 2: Moderate concerns in the adequacy of findings (scarce and thin data) 3: Moderate concerns in relevance of findings, since these were reported in populations not participating in self-management interventions, they were collected based on general experiences with diabetes management. 4: 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. 5 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. |
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The guideline panel judged that there is probably 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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The guideline panel judged that the balance of effects probably favorus the intervention. This is due to the desirable effects, the trivial undesirable effects, the lack of uncertainty and variability of 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 438 euros, with a range from 11 to 1565 euros. Incremental health costs (without the intervention) was 604 euros. Note: This average/range estimate has been based on 13 cost estimates of SMI for obesity reported in publications. |
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| ADDITIONAL CONSIDERATIONS | ||||||||||||||||||||||||||||
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The guideline panel considered that the resources required for this intervention varies.
We could not provide cost for any specific type of SMI intervention. Instead the cost described is the average across all the SMIs assessed in the overall network meta-analysis Costing data for SMIs should be interpreted with caution. We used the data collected from the included studies on the number of sessions, duration of sessions, group size, and primary person performing the intervention to estimate the labor cost of providing the intervention. In many instances, detailed information was missing in the available literature (for example the average group size or duration of sessions). In those cases, we assumed an average of what was reported within a comparison. Some costs were omitted such as information on booklets and other training materials,
Therefore, these estimates provide uncertain evidence of the potential cost for any given intervention.
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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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The guideline panel has agreed on a very low certainty of the evidence on this domain |
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| Cost-effectiveness Does the cost-effectiveness of the intervention favor the intervention or the comparison? |
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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 438 euros, with a range from 11 to 1565 euros.
NA: non applicable; QALY: quality adjusted life years; ICER: incremental cost-effectiveness ratio Explanations The cost-effectiveness results are for the UK setting. For more information on the cost-effectiveness analysis and the results for other countries, please see the cost-effectiveness section. The ICER calculation is based on total costs and QALY estimations from the cost-effectiveness analyses. While total cost in the cost-effectiveness analyses exclude intervention costs, a minimum and maximum intervention cost was estimated based on literature and added to the total costs to estimate the ICER. As such, the ICERs indicate the potential range of cost per QALY including intervention cost. |
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| ADDITIONAL CONSIDERATIONS | ||||||||||||||||||||||||||||
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The guideline panel judged that the cost-effectiveness does not favor either the intervention or the comparison. Overall interpretation should be that there is a possibility that these SMIs can be cost-effective, but this depends on the intervention costs of the particular intervention. The intervention may cost 1061 euro maximum (headroom estimate), which is within the observed range of cost estimates of SMI in the literature (average 438 euro, range: 11 to 1565).(see below the explanation of headroom analysis). Given the uncertainty in the cost estimates, it is important to be very cautious when comparing the ICERs (incremental cost-effectiveness ratio) for specific SMIs to the headroom to determine the most efficient intervention.
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| Equity What would be the impact on health equity? |
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The panel agreed that if implemented tailored to culture and health literacy it could increase equity. Equity might be affected by geography and accessibility. |
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| Acceptability Is the intervention acceptable to key stakeholders? |
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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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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 Jane-2017 - Weight management program delivered by a booklet - 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 § Managing devices
Kliemann-2017 - A leaflet containing ten tips for weight loss and healthy habits formation, a self-monitoring log book and a wallet-sized shopping guide on how to read food labels - 1 individual face-to-face session - Duration 3 months - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Eating behaviours § Doing physical activity o Clinical management § Self-monitoring
Usually, duration of follow-up was not provided in the studies.
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| Feasibility Is the intervention feasible to implement? |
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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 | ||||||||||||||||||||||||||||
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The guideline panel judged that this type of SMI is probably feasible.
Lack of human resources may make the implementation difficult.
Studies' Interventions Logue-2005 - Dietary and exercise advice, prescriptions, and three 24-hour dietary recalls every 6 months - 4 individual face-to-face sessions - Duration 24 months - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Eating behaviours § Doing physical activity o Clinical management § Self-monitoring § Physical management
Alcantara-Aragon – 2018 - Tailored exercise and dietary prescriptions based on a Mediterranean dietary pattern, food intake logged on paper - 7 individual face-to-face contacts - Duration 6 months - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Eating behaviours § Doing physical activity o Clinical management § Self-monitoring
Austel-2015 - Modified Mediterranean-type diet using fat modification - 12-week self-help modified Mediterranean-type diet, 6 weeks of diet plans and 6 weeks of weight loss maintenance training - 12 individual face-to-face sessions - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Eating behaviours o Clinical management § Self-monitoring § Physical management
Jamal-2016 - Dietary counseling sessions - 2 individual face-to-face sessions, once every 12 weeks - Duration 6 months - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Eating behaviours § Doing physical activity
Cayir-2015 - Pedometers as a motivational technique - 6 individual face-to-face sessions - Duration 3 months - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Doing physical activity
Bergman-2018 - Treadmill workstations that enable office workers to walk on a treadmill while working at their computers - 1 face-to-face session, 4 internet-based sessions when needed; all individual - Duration 13 months - Expected patient (or carer) self-management behaviours: o Lifestyle related behaviours § Doing physical activity o Clinical management § Self-monitoring § Managing devices o Social management § Fitting in at work
Usually, duration of follow-up was not provided in the studies. |
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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 |
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In patients with Obesity, the COMPAR-EU Obesity panel, suggests the use of monitoring techniques, rather than usual care (conditional, very low certainty of the evidence about the effects). |
| Justification |
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The COMPAR-EU Obesity panel made a conditional recommendation in favour of Monitoring techniques, rather than usual care alone, due to a probably favourable balance of effects and cost-effectiveness that does not favour either the intervention or the comparison. |
| Subgroup considerations |
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None. |
| Implementation considerations |
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- It should consider the patient specific factors such as medical history and current psychosocial situation, Local factors and HCP skills 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 Education the most important contextual factors to keep in mind are:
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| Monitoring and evaluation |
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No suggestions. |
| Research priorities |
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- 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. - Future studies should address patient well-being. - Future studies should addresss practical outcomes for patients with obesity, for example, levels of cortisol, inflammation markers and include psychological needs of the patients. - Future studies should address patient's related costs. Critical outcomes
Important outcomes
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| REFERENCES SUMMARY |
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Summary of findings of network meta-analysis
COMPAR-EU Isof Web
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 | |
Depression | -0,2063 (-1,2956 to 0,8829) | -0,1101 (-0,6118 to 0,3915) | -0,3448 (-0,8812 to 0,1916) |
Self-efficacy | 0,8434 (0,3176 to 1,3693) | -0,3121 (-0,8024 to 0,1781) | 0,1613 (-0,4953 to 0,8179) |
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.
| Physical Activity | Quality of life-Physical and psychological functioning | Weight management | Healthy nutrition habits/personalized nutrition | Comorbidities managament | Self-efficacy | |
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| Monitoring techniques | ||||||
| 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 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.
- Future studies should address patient well-being.
- Future studies should addresss practical outcomes for patients with obesity, for example, levels of cortisol, inflammation markers and include psychological needs of the patients.
- Future studies should address patient's related costs.
Critical outcomes
- Self-Efficacy
- Eating self-efficacy
- Exercise self-efficacy ((Physical activity; Steps per day)
- Qol (Stress; Depression)
- Blood pressure (SBP; DBP)
- Long term complications
- Weight management (BMI; waist; weight; body fat)
Important outcomes
- Patient activation
- Self-monitoring (dietary; weight)
- Adherence (to medication; to programme)
- Comorbidities (diabetes)
- Dietary habits (Dietary habits; Fat consumption, fibre consumption; carbohydrates; fruit and vegetable; consumption of fat)
- Coping with the disease
Background
Overweight and obesity are chronic metabolic diseases considered as a global public health problem, highly prevalent among adult population (i.e., ̴40%). Obesity increases the risk for many other diseases like diabetes, hypertension, and cancer, thus is a leading cause of disability and death. Some self-management interventions, as behavioural-based weight-loss interventions, have shown more weight loss than usual care and a decreased risk of developing diabetes. However, other health outcomes and long-term effects have been less well reported. Also, the association between weight loss and other health outcomes is still not clear.
