FormalPara Key Summary Points

Why carry out this study?

People with overweight or obesity may face communication challenges and other barriers to pursuing effective weight-management strategies with their healthcare providers.

The aim of this study was to develop a patient-completed assessment tool to facilitate conversations related to weight management between patients and healthcare providers.

What was learned from the study?

A five-item, patient-completed measure was rigorously developed to encourage and facilitate conversations regarding weight between patients and healthcare providers.

The tool is expected to foster patient self-advocacy for individuals with overweight or obesity by giving them an opportunity to define their weight-management goals and discuss these, along with various medical interventions, with a healthcare provider.

The tool provides insight into patients’ past challenges and goals for weight management, thus paving the way for patient-centered discussions of weight-management strategies with providers.

Introduction

Obesity, an adiposity-based chronic disease, and its complications are contributing to a global health crisis [1,2,3], with 13% of the world’s population having obesity in 2016 [4]. In the USA, the prevalence of obesity increased from 30.5% in 1999–2000 to 42.4% in 2017–2018 [5]. Obesity-related comorbidities are numerous, including cardiometabolic disease (metabolic syndrome and increased cardiovascular risk), dysglycemic-based chronic disease including type 2 diabetes, and reproductive disease [6,7,8,9,10]. In addition to these health risks, health-related quality of life (HRQOL) impairments associated with obesity are significant and increase with greater severity of obesity [11]. Weight loss is generally associated with improvements in HRQOL and reductions in obesity-related comorbidities [12, 13].

Increasingly, obesity is understood as a multifactorial and chronic disease with environmental, sociodemographic, behavioral, psychological, physiologic, and medical determinants [14, 15]. The ACTION (Awareness, Care, and Treatment In Obesity maNagement) study to examine obesity-related perceptions, attitudes, and behaviors among 3008 adults with obesity and 606 healthcare providers (HCPs) in the USA found that people with obesity who had maintained a weight loss of at least 10% for a year were more likely to report having received a medical diagnosis of obesity and to have discussed a weight-loss plan with an HCP [16].

Despite the positive association between patient–HCP communication and weight loss, people with overweight or obesity encounter barriers to pursuing effective weight-management strategies with their HCPs [17]. Such barriers include persistent stigma, suboptimal treatment, and communication challenges, particularly in the primary care setting [18]. A joint consensus statement with recommendations to eliminate weight bias was developed by a group of multidisciplinary international experts [19]. Even among HCPs who report being comfortable with weight-related conversations, time constraints limit these efforts. In the ACTION study, only 24% of people with obesity had a scheduled follow-up after an initial weight-related conversation with an HCP [17]. In the primary care setting, open and positive patient–provider communication and increased awareness of patients’ and providers’ respective beliefs can improve weight-management discussions and interventions [18, 20].

The purpose of this study was to develop a brief, self-completed assessment tool to facilitate communications between patients with overweight or obesity and their HCPs about the impact of excess weight on patients’ lives (as perceived by the patient), paving the way for an open dialog about treatment options. To maximize the utility of the tool, an iterative and systematic development process was followed with concept identification and tool modifications guided by input from clinical experts and individuals with overweight or obesity.

Methods

Study Design Overview

The patient assessment tool was developed iteratively (Fig. 1), beginning with the identification of common and important impacts of obesity on patients’ functioning identified during prior qualitative research conducted with patients during development of the validated Impact of Weight on Quality of Life–Lite Clinical Trials questionnaire (IWQOL-Lite-CT) [21,22,23] and the Impact of Weight on Daily Activities Questionnaire (IWDAQ), two obesity-specific patient-reported outcome (PRO) measures [24]. An initial version of the tool, addressing key concepts, was developed and subsequently refined on the basis of feedback from key opinion leaders (KOLs) in the field of obesity. Three iterative rounds of qualitative interviews were then conducted with individuals with overweight or obesity to further refine and maximize the content validity of the tool. Considering the results of all patient interviews, the same KOLs reviewed the revised tool and provided input for its finalization.

Fig. 1
figure 1

Study overview. KOL key opinion leader

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Study Participants

Adult men and women in the USA meeting the following inclusion criteria were eligible to participate in web-enabled patient interviews: an age of at least 18 years; body mass index (BMI; kg/m2), based on self-reported weight and height, greater than 30 or 27.0–29.9 with at least one weight-related comorbidity (e.g., musculoskeletal pain, cardiovascular disease, sleep apnea, prediabetes, or type 2 diabetes); previous weight-loss attempts; interest in losing weight and discussing weight with an HCP; ability and willingness to participate in a 1-h interview in English; and access to a computer or tablet with a video camera and high-speed internet (to participate in the interview). Women who were pregnant at the time of the study, those self-reporting Cushing syndrome or hypothyroidism, and those self-reporting a diagnosis of bipolar disorder or schizophrenia were excluded.

Tool Development

Step 1: Development of an Initial Draft

To identify the most common and important impacts of obesity from the patient perspective for inclusion in the initial draft of the tool, the study team collaboratively reviewed the results of previous qualitative patient interviews conducted during development of two obesity-specific PRO measures, the validated IWQOL-Lite-CT [21,22,23] and the IWDAQ [24], as well as rates of endorsement for individual IWQOL-Lite-CT items within several phase 3a clinical trials of semaglutide for weight management. To optimize the potential relevance and importance of selected concepts, those endorsed by at least 35% of patients were considered. After discussion among the study team, additional concepts were identified for tool inclusion to further facilitate communication and engage patients in information sharing (e.g., by reflecting previous weight-loss attempts and interest in speaking with an HCP about treatment options).

Three clinicians (R.L.K. and K.N., plus a nonauthor clinician) and one patient advocacy representative (J.N.) provided insight on patient–HCP communications regarding weight and provided feedback on drafts of the patient assessment tool before and after testing it with patients.

Step 2: Patient Interviews and Tool Refinement

L&E Research, a qualitative research firm, recruited participants with overweight or obesity for qualitative patient interviews using their proprietary nationwide panel. A diverse sample with regard to sex, educational levels, ages, and US geographic areas, as well as general representation, was targeted. The study materials and protocol were reviewed on ethical grounds by the institutional review board of RTI International, and the study was deemed exempt from full review. The study was conducted in accordance with the 1964 Declaration of Helsinki and its later amendments. All participants provided verbal informed consent to participate in the study and have their responses and characteristics published in summary form, which was considered sufficient for a non-interventional interview study, prior to initiation of the interviews. Each 60-min, web-conference interview was audio recorded and conducted by two experienced qualitative interviewers (T.M.B. and C.K.). Each interview began with a brief introduction to the study followed by a concept elicitation exercise, wherein interview participants answered open-ended questions about the impacts of obesity on their lives that were most important to them. Following the concept elicitation portion of each interview, cognitive debriefing was conducted to assess how participants interpreted the items included in the tool and selected their responses, to identify any refinements necessary to facilitate use of the tool, and to gather additional information about participants’ perceptions of the concepts included in the tool and any important concepts that may have been missing.

Analyses

Immediately following each interview, key learnings were identified and discussed by the interviewers. This step was followed by more formal thematic analysis facilitated by interview transcripts and field notes. Specifically, the relative importance and frequency with which concepts were reported was tabulated. On the basis of participants’ feedback, the clarity and ease of response to each item, as well as the overall comprehensiveness of the tool, were evaluated. If new concepts were mentioned and deemed relevant, they were added to the tool; item modifications were also driven by participant input.

Results

Step 1: Development of an Initial Draft

On the basis of previous qualitative research, 24 specific concepts related to the impact of obesity on patients’ lives were identified and informed development of the initial draft of the tool. These concepts were transformed to positively worded statements by the inclusion of a common stem (“If I lost weight, I would...”), and agreement with each statement was measured on a five-point verbal response scale ranging from strongly agree to strongly disagree (weight-loss benefit statements). The initial draft of the tool was updated on the basis of the KOLs’ recommendations, which resulted in a version with 19 weight-loss benefit statements (reduced from the initial set of 24) for testing in the first round of patient interviews. KOLs stressed the importance of the tool’s wording to avoid offending patients or suggesting blame or shame so that patients would feel comfortable discussing weight with their HCP. KOLs recommended using a friendly title (Feeling Frustrated About Your Weight) and introducing the tool in the context of obesity as a disease.

Step 2: Patient Interviews and Tool Refinement

A total of 18 adults participated in three rounds of interviews (six participants per round). The tool was refined following each round of interviews to incorporate feedback from concept elicitation and cognitive debriefing discussions. The overall sample had a mean age of 41 years and an equal representation of male and female participants; 38.9% of the sample was White with a mix of BMI categories, education levels, and geographic location within the USA (Table 1).

Table 1 Characteristics of participants by round
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Concept Elicitation

Interview participants were asked to share their weight history, including the impact of weight on their lives and strategies they had employed to lose weight in the past, if any (Table 2). Most participants shared long-term struggles with their weight and reported multiple attempts to lose weight in the past, most commonly centering on diet changes (n = 16) and/or increased physical activity/exercise (n = 14). Despite some success with weight loss in the past, participants shared that the main challenge was weight maintenance (keeping the weight off). All participants referenced the impact of their weight on some aspect of their lives, including health/comorbidities (n = 5), physical function (n = 4), emotional/mental functioning (n = 7), social life (n = 4), physical appearance (n = 6), work/career (n = 3), and family life (n = 2). For all participants, in addition to losing a specific amount of weight, overcoming these weight-related negative impacts was an important goal.

Table 2 Concept elicitation patient feedback (N = 18)
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All participants reported having discussions with physicians regarding their weight and weight loss in the past (Table 2). Most participants reported that the discussions had been initiated by their physicians (n = 12), while others reported either a combination of physician- and self-initiated conversations (n = 3) or solely self-initiated conversations (n = 3). There were mixed reactions regarding prior interactions with physicians regarding weight and weight loss regardless of who initiated the conversations. The majority of participants (n = 14) were open to using medications to aid weight loss. However, they were generally unsure of currently available medications and shared concerns about potential side effects and costs of medications as well as rebound weight gain upon treatment discontinuation (Table 2).

Cognitive Debriefing of the Patient Assessment Tool

The tool was refined over three iterative rounds of patient interviews; the Supplementary Material presents the final version of the tool. “Feeling Frustrated About Your Weight” was selected as the tool title based on feedback from patients and KOLs. Participants appreciated the introductory statements explaining that myriad factors influence weight management and acknowledging the importance of lowering the risk for weight-related conditions through small reductions in weight. Participants generally felt that the statement was motivating, informative, and nonjudgmental, sharing that it validated their perceptions regarding weight and weight loss.

While debriefing item 1, describing the benefits of weight loss, round 1 participants were asked how much they agreed or disagreed with 19 concepts capturing anticipated weight-loss goals. On the basis of participant feedback, an additional statement regarding sex life was added to subsequent interview rounds (Table 3). In each round, after participants provided a response and feedback to each concept, they were asked to identify the “top five” most important concepts. Almost all participants agreed (i.e., selected agree or strongly agree) with the statements that were included in their top five.

Table 3 Weight-loss benefits patient feedback (item 1)
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Across all three rounds of interviews, participants reported that the open-ended question (“In your own words, why would you like to lose weight?”; item 2) was clear as written and important to include in a tool designed to encourage patient–HCP discussion about weight. No changes were made to this item, and it was retained for the final patient assessment tool.

Participants in all three interview rounds considered the question about prior weight-loss efforts (item 3) to be clear as written and important to include in the tool. No changes were made to the question, but the response options were refined on the basis of feedback from round 1 and/or round 2 interviews and tested in subsequent rounds. This item was retained for the final patient assessment tool.

Participants believed that the question regarding willingness to speak with an HCP about weight (item 4) was clear as written. Even though a few participants assumed that anyone who took time to complete the form was already interested in speaking with an HCP about their weight, they did not feel that the item would be burdensome to complete. No changes were made to this item, and it was retained for the final patient assessment tool.

Across all three rounds of interviews, participants reported that the question about discussion topics with an HCP (item 5) was clear as written and would facilitate patient–HCP discussion regarding weight-management strategies. No changes were made to the question, but the response options were refined on the basis of feedback from the round 1 and/or round 2 interviews and tested in subsequent rounds. This item was retained for the final tool.

Overall, participants felt that the tool was comprehensive in its coverage of topics that could be discussed between patients and HCPs regarding weight loss. As such, participants did not suggest any additional concepts or items that they believed should be included in the tool. Participants expressed their belief that the tool would achieve its intended purpose of facilitating weight-related discussions between patients and HCPs. Furthermore, they found the tool to be motivating and felt that it would encourage self-advocacy in that they felt validated with little, if any, self-blame.

Tool Finalization

During the second consultation with KOLs, refinements made to the tool between interview rounds based on participant feedback were discussed, and key decisions were made about which of the 19 weight-loss benefit statements should be retained in item 1. The decision was made to retain the weight-loss benefit statements endorsed as most important and relevant by patients and KOLs while also maintaining a smaller number of statements for the brief tool. A total of eight weight-loss benefit statements were retained in item 1 for the final tool. These concepts were consistently deemed important by participants; each was also selected by at least 33% of participants as a “top five” concept and endorsed by all four KOLs (Table 4). No changes were made to any other items.

Table 4 Summary of patient and KOL feedback on weight-loss benefit statements
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Discussion

This study aimed to develop a brief, self-completed assessment tool to facilitate communications between patients with overweight or obesity and their HCPs about the impact of excess weight on patients’ lives (as perceived by the patient), paving the way for an open dialogue about treatment options. In addition to items pertaining to patients’ feelings and experiences related to their weight, the measure includes eight potential benefits of weight loss:

  • Be healthier

  • Live longer

  • Feel better about myself

  • Have more energy or stamina

  • Have fewer aches and pains

  • Be able to find clothes I feel good in

  • Be more physically active

  • Feel more confident

Respondents are asked to rate their degree of agreement (or disagreement) with each statement “If I lost weight I would...”. To ensure that patients are able to express more personal or unique goals in the assessment tool, it also includes an open-ended statement for completion. Furthermore, the final tool includes information on obesity to both inform and support users (patients and HCPs), as well as historical information on past weight-loss strategies and patients’ desires for future strategies to guide patient–HCP discussion.

On the basis of KOL feedback and patients’ prior experiences, awareness and acceptance of the tool by HCPs likely to come in contact with it (i.e., likely to be presented a completed tool by patients) will help maximize the utility of the tool and should potentially be considered a prerequisite to its dissemination. As part of this adoption, HCPs need education about obesity as a chronic, adiposity-based disease and available resources to fully support the intended goal of the tool. It is anticipated that a multistep and multi-sourced communications plan will be needed to ensure sufficient and successful HCP adoption and patient access.

Limitations of this study are acknowledged. Participant recruitment was purposeful, aimed at obtaining a mix of participants to obtain a sample that generally reflects the intended end user of the patient tool, although representativeness of the population at large cannot be assured with the intentional small sample. Given the wealth of qualitative interview data available from development of the IWQOL-Lite-CT and the IWDAQ, as well as input from KOLs, the focus of the interviews in this study was on refining the draft tool rather than de novo concept elicitation. As such, a large sample would have been unnecessary because major issues with the tool should be revealed with just a few interviews [25]. Sample sizes of 5–15 have been suggested as a typical range [26]. A sample size of 18, including three rounds of interviews with six participants each, was considered appropriate for this study.

Another potential limitation is that views of both patient and KOL participants may not be fully representative of the populations from which these research samples were drawn. For example, participants who provided feedback on the tool expressed both a desire to lose weight and willingness to participate in the study. As such, on average, they may have been more motivated to lose weight than many individuals with overweight or obesity. Finally, feedback obtained from four KOLs cannot be considered representative of all HCPs or experts in the field of obesity.

Conclusions

The patient assessment tool is a five-question, self-completed measure, expected to require less than 5 min for completion. The tool was rigorously developed for the purpose of encouraging and facilitating conversations between patients and their HCPs. On the basis of participant feedback, the tool is expected to foster patient self-advocacy for individuals with overweight or obesity by giving them an opportunity to define their weight-management goals and discuss these, along with various medical interventions, with an HCP. Additionally, this tool can capture important information for HCPs by providing insight into patients’ past challenges and future goals with regard to weight management, thus paving the way for a patient-centered and personalized strategy for discussion.