The development of a core outcomes set for self‐management interventions for patients living with obesity

Abstract

Self-management interventions (SMIs) can improve the life of patients living with obesity. However, there is variability in the outcomes used to assess the effectiveness of SMIs and these are often not relevant for patients. In the context of COMPAR-EU, our aim was to develop a core outcome set (COS) for the evaluation of SMIs for patients with obesity. We followed a four steps multimethod approach:(1) the development of the initial catalogue of outcomes; (2) a scoping review of reviews on patients' values and preferences on outcomes of self-management (SM);(3) a Delphi survey including patients and patient representatives to rate the importance of outcomes; and (4) a 2-day consensus workshop with patients, patient representatives, healthcare professionals and researchers. The initial catalogue included 82 outcomes. Ten patients and patient's representatives participated in the Delphi survey. We identified 16 themes through the thematic synthesis of the scoping review that informed 37.80% of the outcomes on initial catalogue. Five patients, five healthcare professionals, and four researchers participated in the consensus workshop. After the consensus process, 15 outcomes were selected to be part of the final COS, and five supplementary outcomes were also provided. We developed a COS for the evaluation of SMIs in obesity with a significant involvement of patients and other key stakeholders. This COS will help improving data synthesis and increasing the value of SM research data in healthcare decision making.

Self-management interventions for adults living with obesity to improve patient-relevant outcomes: An evidence map

“…Our inclusion criteria included: i) Population, adults (≥18 years of age) with a diagnosis of overweight (defined as having a BMI ≥ 25 kg/m 2 or ≥ 23 kg/m 2 in case of Asian population) or obesity (defined as having a BMI ≥ 30 kg/m 2 or ≥ 25 kg/m 2 in case of Asian population) and their informal caregivers. When a study had a mixed population of patients (i.e., not only people living with overweight or obesity) and did not report the outcomes per condition separately, it was included if at least 80% of the population targeted the chronic condition of interest; ii) Intervention, SMIs; iii) Comparison, usual care (usual care or usual care plus if included self-management support techniques), other SMIs (head-to-head) and not SMIs (excluding surgery); iv) Outcomes, studies must have reported at least one of the outcomes from the “COMPAR-EU” predefined COS [12] ; v) Study design, RCTs; quasi-randomized studies were excluded. We included only studies published in English or Spanish [10] .…”

“…The level of adaptation or modification of the SMI when delivered to the study population (tailoring) was as well assessed and extracted. The list of outcomes considered for extraction were classified into basic empowerment, adherence to self-management behaviours, clinical outcomes, patient/informal caregiver quality of life, care perception/satisfaction and costs (see Table 1 for more detail) [12] .…”

“…The taxonomy of SMIs [11] was refined and validated through expert consultation, including patients’ representatives and allowed us to define the components that helped us extract the information about the interventions from the included studies. The obesity “COMPAR-EU” COS [12] was developed together with patients, patients’ representatives and professionals and also included a systematic review on patients and informal caregiver priorities regarding treatment [21] . Descriptive findings displayed in this study have been presented and discussed in a “COMPAR-EU” patient panel lead by the European Patient Forum.…”

“…The taxonomy includes four domains: target population characteristics, intervention characteristics, expected patient (or informal caregiver) self-management behaviors and patient-relevant outcomes [11] . For selecting the outcomes, we developed a Core Outcome Set (COS) specifically for SMIs for adult people living with overweight or obesity in Europe [12] . This COS was developed with patients, patient representatives and healthcare professionals, including a systematic review on patients and informal caregiver priorities [12] .…”

“…For selecting the outcomes, we developed a Core Outcome Set (COS) specifically for SMIs for adult people living with overweight or obesity in Europe [12] . This COS was developed with patients, patient representatives and healthcare professionals, including a systematic review on patients and informal caregiver priorities [12] . Within “COMPAR-EU” project, a comprehensive systematic review and network meta-analysis was performed on any SMI for type 2 diabetes, obesity, chronic obstructive pulmonary disease, and heart failure.…”