Patient-reported outcome (PRO) instruments are questionnaires designed to measure outcomes of importance to patients from their perspective. This article describes the methods used to develop a new PRO instrument for obese patients and patients having bariatric and cosmetic body contouring surgery. The BODY-Q is composed of 19 newly designed scales that measure: (1) appearance; (2) health-related quality of life; and (3) process of care. Recommended guidelines for PRO instrument development were followed to ensure that the BODY-Q meets requirements of regulatory bodies. The BODY-Q is currently being field-tested in an international study.
Key points
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Weight loss following bariatric surgery leaves many patients with unsightly excesses of skin.
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Body contouring procedures have the potential to improve appearance and health-related quality of life.
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Patient-reported outcome (PRO) instruments are questionnaires designed to measure outcomes from the point of view of the patient.
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The BODY-Q is a new PRO instrument designed for obese patients and patients having bariatric and cosmetic body contouring surgery.
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BODY-Q scales measure appearance, health-related quality of life, and process of care.
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The BODY-Q can be used to measure change over the entire weight loss journey, starting at obesity and ending after body contouring surgery is performed.
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The BODY-Q is being designed using modern psychometric methods (ie, Rasch Measurement Theory analysis).
Introduction
Increasing rates of obesity, coupled with the growing pursuit of a slender physique, have resulted in an increasing number of people seeking both bariatric and body contouring surgery. Although bariatric surgery and subsequent weight loss may have a positive impact on medical conditions such as diabetes and heart disease, many patients seek such procedures primarily to improve quality of life and body image. This trend is also true for many normal-weight patients, who increasingly pursue cosmetic body contour surgery to address so-called problem areas and to improve satisfaction with their appearance.
Bariatric Surgery
Bariatric surgery has been shown to be the most effective therapy available for weight loss in moderately and severely obese people. In addition to reducing body weight, such surgery can improve or resolve a range of obesity-related conditions, such as type 2 diabetes, heart disease, sleep apnea, hypertension, and high cholesterol. The large amount of weight loss that can be achieved through bariatric surgery leaves many patients with excess skin that is cosmetically unsightly as well as detrimental to their body image and physical, psychological, and social function; that is, their health-related quality of life (HR-QOL).
Research measuring the HR-QOL impact of bariatric surgery requires urgent attention. After reviewing 26 publications in a National Institutes of Health Research (United Kingdom) clinical and cost-effectiveness study of bariatric surgery, the investigators called for further research to provide detailed data on patient HR-QOL because of conflicting findings. More recently, a systematic search by Tayyem and colleagues, who looked for HR-QOL instruments used in bariatric research, identified that 112 studies used 42 HR-QOL instruments (8 generic, 9 obesity specific, and 25 other condition-specific instruments). The content (items and scales) of these 42 questionnaires varies substantially, suggesting a lack of consensus about which questionnaires should be used to measure patient outcomes. The most frequently used generic patient-reported outcome (PRO) instrument was the Short Form 36 (SF-36), which was used in 28 studies. Although generic instruments are helpful for making comparisons with population norms and other patient groups, the use of such an instrument in research with patients having bariatric surgery and/or body contouring would miss important health concepts and underestimate the HR-QOL impact of their condition.
The most frequently used condition-specific instruments included the Moorehead-Ardelt Quality of Life Instrument (MAQOL), Impact of Weight on Quality of Life–Lite (IWQOL-Lite) instrument, and the Swedish Obese Subjects Obesity Psychosocial Problem (OSQOL) module. The most common of these, used in 29 studies, was the MAQOL, created to accompany the Bariatric Analysis and Reporting Outcome System (BAROS), which measures bariatric surgery clinical outcomes. This short HR-QOL instrument is composed of only 6 items that cover self-esteem and physical, social, work, sexual, and eating behavior. The MAQOL does not ask about appearance even though bariatric patients are usually left with excess hanging skin, which has a negative impact on their HR-QOL.
Two additional measures that are specific to bariatric patients and are not covered in the Tayyem and colleagues review are the Bariatric Quality of Life (BQL) Index and the Treatment Related Impact Measure of Weight (TRIM-Weight). The BQL assesses HR-QOL in terms of 14 items (eg, exercise, social activities, feeling under pressure, depression, life satisfaction, restrictions, self-confidence). The TRIM-Weight is a new 22-item questionnaire developed to measure the key HR-QOL impact of bariatric medicine. This instrument was developed by carefully following internationally recommended guidelines for item generation, item reduction, and psychometric evaluation.
Body Contouring
Body contouring is a growing area in plastic surgery. According to the 2013 American Society of Plastic Surgery procedural statistics, 436,006 body contouring procedures were performed in the United States and included liposuction (199,817), abdominoplasty (111,986), upper arm lift (15,769), breast lift (mastopexy) (90,006), thigh lift (8709), lower body lift (7281), and buttock lift (2438). Together, these procedures made up 26.1% of total cosmetic surgical procedures in 2013. Although body contouring for cosmetic reasons is common, body contouring following massive weight loss is less common. In 2012, a total of 45,534 body contouring procedures were performed on patients after massive weight loss. Whether performed purely for cosmetic reasons or as a component of the post–bariatric surgery treatment plan, body contouring surgery has the potential to improve or restore a patient’s body image and HR-QOL.
Our team published a systematic review of HR-QOL instruments in patients having body contouring surgery. MEDLINE, EMBASE, PsychINFO, CINAHL, HAPI, Science Citation Index/Social Sciences Citation Index, and Ovid Evidence Based Medicine databases were searched from the inception of each database to August 2010. Articles included in the study described the development and/or psychometric evaluation of a PRO instrument for patients having body contouring. From 1504 articles 5 such instruments were found, including a liposuction questionnaire (Freiburg Questionnaire on Aesthetic Dermatology and Cosmetic Surgery ), a general plastic surgery questionnaire (Derriford Appearance Scale ), and 3 breast reduction instruments: Breast Reduction Assessed Severity Scale Questionnaire (BRASSQ), Breast Related Symptoms questionnaire, and the BREAST-Q. Detailed examination by our team revealed that the first 3 instruments are limited in terms of content range and psychometric properties, leaving only 2 breast surgery–specific instruments that have strong psychometric properties and could be recommended for use. Although the BREAST-Q and BRASSQ could be used with patients having breast reduction, there is a lack of adequately developed instruments for other body contouring procedures.
Need for a New PRO Instrument: The BODY-Q
An important oversight in the literature to date is the lack of evidence about how HR-QOL and other important patient outcomes, such as body image and satisfaction with appearance, change over the weight loss journey (ie, starting at obesity and ending after body contouring surgery is performed). A limitation in the pursuit of such evidence is the lack of availability of an instrument designed specifically to cover concerns that are common across patients having cosmetic body contouring surgery as well as obese patients and patients after massive weight loss. To address this oversight, our team set out to develop a new PRO instrument called the BODY-Q. We followed recommended guidelines for PRO instrument development to ensure that the BODY-Q meets requirements of regulatory bodies. In the first phase, a conceptual model to be measured is formally defined, and a pool of items is generated and developed into scales. In the second phase, the scales are field-tested in a large sample of target subjects. In the field test, items for the refined scales are retained based on their performance against a set of psychometric criteria and the new scales are evaluated with respect to their psychometric properties (ie, reliability, validity, responsiveness). In the third phase, psychometric evaluation of the item-reduced scales is performed in various samples of participants to further explore, report, and improve the scientific soundness of the instrument. This article describes the steps we have taken to date to develop the BODY-Q scales, and what remains to be accomplished to refine these scales for future use in research and clinical practice.
Methods and results
Phase 1
Theoretic approach
We started our research by developing a conceptual framework and preliminary set of scales using an approach called interpretive description, which is an applied health services qualitative method. Interpretive description presumes that there is theoretic knowledge, clinical knowledge, and a scientific basis informing a study.
Literature review
As described briefly earlier, we conducted a systematic literature review to identify published PRO instruments for patients having body contouring surgery. The 2 objectives for the review were to identify instruments designed to measure patient satisfaction, body image, and/or quality of life issues of patients having body contouring surgery; and to evaluate these instruments with respect to their development process, content, and psychometric properties. We searched multiple databases from their inception to August 2010. In each database, we used search terms that enabled us to find relevant articles for the following topics: obesity or overall body image, plastic surgery in general or specific body contouring surgical procedures, and quality of life outcomes in general or as assessed with questionnaires. From articles that used a PRO instrument, we evaluated the content to identify preoperative and postoperative issues likely to be relevant to the body contouring population. Five PRO instruments were found that were specifically developed for patients having body contouring. The content covered in these instruments helped our team in the development of an initial interview guide ( Box 1 for example questions).
Why did you decide to have weight loss and/or body contouring surgery?
What methods of weight loss you have used in the past?
Tell me about the weight loss and/or body contouring surgery you had or are planning to have.
Describe any postoperative issues you experienced after weight loss and/or body contouring surgery (eg, pain, complications).
What was it like going back to work or your normal routine after body contouring surgery?
How have weight loss and/or body contouring changed the way you look?
How satisfied are you with how your body looked before/now?
How satisfied are you with how specific areas of your body looked before/now (eg, arms, abdomen, buttocks, hips, legs, skin)?
Can you describe how your body contouring scars look/feel (eg, redness, swelling, size)?
How did weight loss/excess skin and/or body contouring affect how you look (eg, in clothes, naked, in mirror, photos, age)?
Describe any physical problems caused by your weight/excess skin after weight loss/any changes following body contouring surgery.
Describe any activity limitations caused by your weight/excess skin after weight loss/any changes following body contouring surgery.
Describe how your weight/excess skin after weight loss affected your emotional health and any changes following body contouring surgery.
Describe how your weight/excess skin after weight loss affected how you feel about your body and any changes following body contouring surgery.
Describe how your weight/excess skin after weight loss affected your sexual life and any changes following body contouring surgery.
Describe how your weight/excess skin after weight loss affected social relationships and any changes following body contouring surgery.
Describe how your weight/excess skin after weight loss interfered with your usual social roles and any changes following body contouring surgery (eg, work, family life, friends).
How satisfied are you with the weight loss and/or body contouring health care you received?
How did you feel about the information you received regarding weight loss and/or body contouring?
How did you feel about your weight loss and/or body contouring physician, team, and office staff?
Are you pleased with the results of your weight loss and/or body contouring surgery?
Would you do it again?
Note: these questions are examples of the types of questions asked during interviews. Depending on the treatment history of a participant, questions were tailored to fit their experiences.
Qualitative interviews
We conducted qualitative interviews with 14 patients having cosmetic body contouring and 49 postbariatric patients (37 had undergone body contouring and 12 were waiting for body contouring). Participants were recruited between September 2009 and February 2012 from the offices of 5 plastic surgeons located in the United States and Canada. We interviewed patients aged 18 years or older who had undergone bariatric surgery and were at any point along their weight loss journey and/or patients who had undergone any form of body contouring surgery within the past 7 years. Patient characteristics are shown in Table 1 . Interviews were used to explore the impact that obesity, weight loss, and body contouring surgery had on participants’ appearance and HR-QOL (eg, physical, psychological, sexual, and social function), and process of care (eg, relationship with health care providers, expectations, information needs). The interviews were digitally recorded and transcribed verbatim with any identifiable information excluded from interview transcripts.
| Qualitative Interviews | Cognitive Interviews | ||
|---|---|---|---|
| Round 1 | Round 2 | ||
| Number of Participants | 63 | 19 | 3 |
| Age (y) | |||
| Mean (SD) | 48 (12) | 47 (11) | 42 (3) |
| Range | 23–71 | 28–63 | 39–44 |
| Gender, N (%) | |||
| Female | 60 (95) | 16 (84) | 3 (100) |
| Male | 3 (5) | 3 (16) | 0 (0) |
| Marital Status, N (%) | |||
| Married/common law | 32 (51) | 10 (53) | 1 (33) |
| Other | 31 (49) | 8 (42) | 2 (67) |
| Missing | 0 | 1 (5) | 0 |
| Highest Level of Education, N (%) | |||
| High school | 8 (13) | 2 (11) | 1 (33) |
| College/university diploma | 50 (79) | 11 (58) | 2 (67) |
| Other | 0 | 5 (26) | 0 |
| Missing | 5 (8) | 1 (5) | 0 |
| Employment Status, N (%) | |||
| Employed | 38 (60) | 13 (68) | 2 (67) |
| Other | 22 (35) | 5 (26) | 1 (33) |
| Missing | 3 (5) | 1 (5) | 0 |
| Household Income, N (%) | |||
| <$40,000 | 10 (16) | 3 (16) | 1 (33) |
| $40,000–100,000 | 30 (48) | 7 (37) | 2 (67) |
| >$100,000 | 14 (22) | 7 (37) | 0 |
| Missing | 9 (14) | 2 (10) | 0 |
| Type of Patient, N (%) | |||
| Cosmetic body contouring | 14 (22) | 11 (58) | 0 |
| Before weight loss body contouring | 12 (19) | 6 (32) | 3 (100) |
| After weight loss body contouring | 37 (59) | 2 (10) | 0 |
| Body Contouring Procedures, N (%) | |||
| Abdominoplasty | 43 (68) | 10 (53) | 0 |
| Liposuction | 27 (43) | 4 (21) | 0 |
| Upper arm lift | 15 (24) | 0 | 0 |
| Breast lift | 12 (19) | 3 (16) | 0 |
| Thigh lift | 9 (14) | 0 | 0 |
| Buttock lift | 6 (10) | 0 | 0 |
| Breast reduction | 9 (14) | 2 (11) | 0 |
| Lower body lift | 5 (8) | 0 | 0 |
Data were coded using a line-by-line approach with the application of codes to text within NVivo 8 software. Constant comparison was used to examine relationships within and across codes in order to develop themes and subthemes. In an earlier qualitative article, we described a range of important health and aesthetic concerns of obese patients, patients after massive weight loss, and patients having body contouring surgery. Note that we described that body contouring played an instrumental role in the completion of the weight loss process for formerly obese patients.
The qualitative findings were used to develop a conceptual framework composed of 3 major themes: appearance, HR-QOL, and process of care. Within each theme were a varying number of subthemes. For example, the subthemes under the HR-QOL theme included body image and psychological, social, sexual, and physical function and physical symptoms.
Development of preliminary items and scales
The next step involved developing a comprehensive set of preliminary items from the qualitative data. This step necessitated creating coding reports within NVivo 8 software in order to extract all the data (coded text) associated with each of the subthemes. For each subtheme, the patient quotes for coded text were cut and pasted into Excel spreadsheets. Then, each code text was considered in turn and 1 or more preliminary items generated. To provide an example, one participant said the following about the appearance of her body after weight loss and before body contouring surgery: “I looked very old. My whole body was like my mother’s [body] who was 90 with all the skin hanging.” This quote was similar to another participant, who said: “You’re, like, older because of that hanging skin there.” These patient’s quotes had been coded as Appearance (theme) as well as Skin (subtheme) in NVivo8. We developed preliminary items from the patient data, which are reflected in the following 2 items that appear in the final version of the Skin scale: “Your excess skin making you look older than you are” and “How much your excess skin hangs.”
Once we had developed a comprehensive list of items, we used the item pool to populate a set of scales. At this stage we also examined other published obesity/bariatric and body contouring–specific PRO instruments to assess whether we had missed any important issues. In creating the wording of items for our scales, our intention was to retain the words of patients as much as possible to ensure that the items would resonate with patients, we used positive or neutral language, and we used simple wording to ensure comprehension.
For each scale, we developed Likert scale scoring options. The response options were limited to 4 labeled options to keep our scales simple and in line with guidelines published by Khadka and colleagues. This research team showed that rating scales with complicated question formats, a large number of response categories, or unlabeled categories tended to be problematic and recommended that PRO instruments should have simple question formats, only a few (4–5 at most) response options, and that all response options should be labeled using words (eg, strongly agree, agree, disagree, strongly disagree).
Cognitive interviews
The BODY-Q scales ( Table 2 ) were shown to 22 patients in a series of one-on-one cognitive interviews. Qualitative methods, such as cognitive interviews, are valuable for identifying new items as well as tailoring existing item wording, item format, and presentation to ensure that they are optimally understood by respondents. Cognitive interviews often lead to modifications to instrument content (eg, item deletion, addition, rewording).
| Name of Scale | Items | Example Item | Response Option Format | Time Frame (wk) | Flesch-Kincaid Grade Level Average (Range) |
|---|---|---|---|---|---|
| Appearance | |||||
| Body | 11 | The size (ie, weight) of your body | Dissatisfied/satisfied | Past 2 | 2.1 (0.5–3.7) |
| Abdomen | 13 | How your abdomen looks when you are naked | Dissatisfied/satisfied | Past 2 | 2.5 (0.0–4.8) |
| Upper arms | 10 | How your upper arms look in long-sleeved shirts | Dissatisfied/satisfied | Past 2 | 1.5 (0.5–5.2) |
| Back | 8 | How the skin on your back looks | Dissatisfied/satisfied | Past 2 | 0.0 (0.0–3.9) |
| Buttocks | 9 | How your clothes fit your buttocks | Dissatisfied/satisfied | Past 2 | 0.9 (0.5–3.6) |
| Inner thighs | 9 | How similar (ie, the same) your inner thighs look | Dissatisfied/satisfied | Past 2 | 1.2 (0.5–4.9) |
| Hips and outer thighs | 10 | The shape of your hips and outer thighs | Dissatisfied/satisfied | Past 2 | 1.3 (0.8–2.6) |
| Excess skin | 14 | Having to dress in a way to hide your excess skin | Not at all/extremely bothered | Past 2 | 4.0 (0.5–7.6) |
| Stretch marks | 13 | The color of your stretch marks | Not at all/extremely bothered | Past 2 | 1.3 (0–4.4) |
| Body contouring scars | 12 | How noticeable your scars are | Not at all/extremely bothered | Past 2 | 1.6 (0.0–5.2) |
| Quality of Life | |||||
| Body image | 12 | My body is not perfect but I like it | Agree/disagree | Past 2 | 2.8 (0.5–6.4) |
| Psychological Function | 16 | I feel good about myself | Agree/disagree | Past 2 | 3.7 (0.5–9.5) |
| Social function | 15 | I feel included in social situations | Agree/disagree | Past 2 | 4.3 (1.0–8.3) |
| Sexual function a | 13/11 | I am comfortable having the lights on during sex | Agree/disagree | N/A | 4.5 (0.5–7.5) |
| Physical function | 13 | Putting on or taking off clothes | All the time/never | Past 2 | 3.4 (0.5–12.3) |
| Physical symptoms | 15 | Skin rash or infection | All the time/never | Past 2 | 3.0 (0.0–9.1) |
| Process of Care | |||||
| Information b | 20/19 | The kinds of complications that could happen | Dissatisfied/satisfied | N/A | 4.4 (0.8–11.1) |
| Doctor | 17 | Talked to you in a way that was easy to understand | Agree/disagree | N/A | 3.9 (0.5–14.6) |
| Medical team | 15 | Treated you with respect | Agree/disagree | N/A | 4.2 (0.5–14.6) |
| Office staff | 17 | Were available when you had concerns | Agree/disagree | N/A | 5.1 (0.5–14.6) |
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