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ComparEuEtdsWeb
QUESTION | |
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1. Should Monitoring and action-based behavioural techniques (problem solving and/or goal settings) vs. Usual care be used for adult patients living with obesity? | |
Population | adult patients living with obesity |
Intervention | Monitoring and action-based behavioural techniques See more |
Comparison | Usual Care |
Main outcomes | Adherence; 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; Exercise self-efficacy; Fiber consumption; Fruit and vegetable consumption; Physical activity; Total steps; Weight-management; Carbohydrates; Consumption of fat; Coping with the disease; Dietary habits; |
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. |
ASSESSMENT | ||||||||||||||||||||||||||||
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Priority of problem Is the problem a priority? |
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JUDGEMENT | RESEARCH EVIDENCE | |||||||||||||||||||||||||||
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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 (LeBlanc, 2018). Also, the association between weight loss and other health outcomes is still not clear. |
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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 | ||||||||||||||||||||||||||||
The guideline panel judged the desirable effects as small. This was due to the effect on blood presssure, considered the most relevant outcome of those that showed at least a small effect.
No data available for the rest of critical/important outcomes.
The pooled affect of all SMIs compared to usual care, showed a marginal effect (little to no effect) across all critical outcomes.
Proportion of direct evidence contributing to the final NMA estimate per outcome: - Adherence: 100% * - DBP: 60% - SBP: 60% - BMI: 51% - Body fat: 70% - Waist size: 60% - QoL: 59% - Depression: 100% - Eating self-efficacy: 60% - Excercise self-efficacy: 0%
*Results for this outcome come an additional pairwise meta-analysis, where Linde et al 2011 was the main study. Linde et al 2011 evaluated a intervention consisting of 90-minute weight control education sessions that emphasized three validated behavioral strategies for weight control: daily monitoring of body weight, healthy dietary habits, and increasing time spent each week in physical activity. Participants were instructed to set specific shortand long-term weight goals by selecting behavioral strategies and adjusting their selection of strategies over time based on preferences and/or weight loss progress. Participants (n=42) where obsese, non-diabetic patients,
Component Network Meta-analysis [Treatment effect (95%Confidence Interval)] : - DBP: -2.39 (-3.28 to -1.51) mmHg - SBP: -2.87 (-4.28 to -1.47) mmHg - BMI: -1.07 (-1.32 to -0.83) kg/m2 - Body fat: -0.18 (-0.45 to 0.07) - Waist size: -3.26 (-3.78 to -2.74) cm - QoL: 0.07 (-0.26 to 0.40) SD - Depression: -0.17 (-0.67 to 0.31) SD - Eating self-efficacy: -0.60 (-1.38 to 0.18) SD - Exercise self-efficacy: 0.38 (-0.37 to 1.14) SD
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 estimates 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 of 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): 82 days of additional life per person - Years with diabetes: 104 fewer days per person - Quality-Adjusted Life Years (QALY): 93 days of additional life equivalent to full health per person (undiscounted) - Diabetes mellitus: 13 fewer events per 1,000 persons - Myocardial infarction: 6 fewer events per 1,000 persons - Stroke: 5 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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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.
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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 due to very serious risk of bias and very serious 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.
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 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. 2: Serious concerns in adequacy of data due to scarce and thin data 3: Moderate concerns in relevance of findings since these were not collected from patients who explicitly participated in SM interventions, some findings may not represent the majority of patients. |
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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.
New habits require changes in obesogenic behaviours and dealing with conflicts between lifestyle changes and other priorities. Patients who find lifestyle behaviours that can be adapted in the long term are more likely to maintain a new weight after losing it. Better physical functioning is a personal motivation for taking or maintaining action regarding weight loss. Negative aspects such as being unhappy with their body image, feeling shame and having a low self-esteem are important motivators for wanting to lose weight. Successful long-term weight loss maintenance is often accompanied by changes in self-concept. Patients face a battle with body standards even in healthcare settings, where devices and furniture are not adapted to their bodies. Depression, anxiety and stress are associated with weight stigma. Unhealthy eating is used as a strategy to regulate emotions by some patients Adherence is a decisive factor in predicting successful weight management. Methods used to help patients to adhere to weight management programmes include self-accountability on food choices/energy intake and self-monitoring that helps to increase attention and adherence to a desired behaviour change through monitoring the target behaviour or by sharing of self-monitored data with others. Better physical functioning and psychological improvement encourage participants to persist with weight management efforts. However, there are factors that limit adherence to weight management programmes, such as negative experiences with health-care professionals, negative self-image, embarrassment about being weighed, unsolicited advice about weight loss, among others. Finally, there are opposing views among patients and healthcare professionals about weight management adherence. Healthcare professionals see non-adherence as an individual personal failing which is not directly linked to the social context, while patients frequently refer to social factors as an important influence on their adherence to weight management. |
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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 438 euros with a range of 11 to 1565 euros.
The incremental health cost (without the intervention) was 862 euros.
Note: The average estimate has been based on 13 cost estimates of SMI for obesity reported in publications. |
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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.
We could not provide the 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). Some costs were omitted such as information on booklets and other training materials,
Therefore, these estimates provide uncertain evidence of the potential cost across all self-management interventions.
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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 Obesity 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.
Explanations
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ADDITIONAL CONSIDERATIONS | ||||||||||||||||||||||||||||
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 are cost-effective, in particular when the range of cost estimates is in the same range as the headroom estimates (see below for an 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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No specific systematic review was conducted to inform 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.
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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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ADDITIONAL CONSIDERATIONS | ||||||||||||||||||||||||||||
The panel felt the acceptability varies given the very different type of interventions. Sample of included trials in the network metanalysis below is based on: 1. Variation in countries; 2. Largest sample sizes; 3. variation in severity, and; 4. most recent years of publication. Logue-2005
Assuncao-2010
Van Gemert-2015
Madigan-2014
Fritz-2011
Gallagher-2014a
Pedersen-2007b
Silina-2017
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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 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. Lack of human resources, healthcare system coordination and transport services may make the implementation difficult. Usually, duration of follow-up was not provided in the studies. |
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 Obesity, the COMPAR-EU Obesity panel, suggests in favour of the use of monitoring and action-based behavioural techniques (problem solving and/or goal settings), rather than usual care (conditional, very low certainty of the evidence about the effects). |
Justification |
The COMPAR-EU Obesity panel made a conditional recommendation in favour of Monitoring and action-based behavioural techniques (problem solving and/or goal settings), rather than usual care alone, due to a probably favourable balance of effects and cost-effectiveness that probably favours the intervention. |
Subgroup considerations |
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 action-based behavioural techniques (problem solving and/or goal setting), the most important contextual factors to keep in mind are:
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Monitoring and evaluation |
Research priorities |
- Future studies should measure patient important outcomes, both critical and important (list below), have adequate sample size and follow-up, including after the intervention is finished. - - Future studies should address also preferences and values of patients in relation to their self management, cost effectiveness and sub-categories of self-monitoring interventions. - Future studies should describe in detail the aspects of the intervention and evalute the long term effectiveness.
Critical outcomes
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-ANALISIS (sensitivity analysis)
Components' definition:
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.
Action-based behavioural change techniques (AB)
Action-based behavioural change techniques (AB)
There are different action-based behavioural change techniques:
Enhancing problem-solving skills. This technique consists in teaching on how to analyse factors that influence your behaviour and provide you or help you to develop strategies to reduce or overcome barriers and/or support facilitators (e.g., not eating unhealthy foods when you feel depressed). Strategies include anticipation, self-treatment, resource utilization, and problem management. Ideally, there should be an initial plan, but this is not a requisite.
Example: Identification and attenuation of environmental barriers (e.g., no gym in the neighbourhood when one want to exercise) and facilitators (e.g., someone who keeps you company during exercise) to everyday physical activities.
Goal setting and action planning. This technique consists in encouraging you to set one or more achievable goals based on your needs and preferences. These goals may be behaviours (e.g., a consuming a healthy meal three times a day) or outcomes (e.g., less pain) and can be used as a starting point. The process usually involves the formulation of a detailed action plan, specifying what you would do and at least when and/or where you will do it. It could also include an assessment of your behaviours with your health care provider and a discussion of goals and the writing up of agreed-on action plans, including plans for emergency situations.
Examples of goals: achieving a daily walking distance of 2 km or a weight loss of some kilograms in x months with diet and exercise.
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.