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538 Obesity Surgery, 15, 2005 © FD-Communications Inc. Obesity Surgery, 15, 538-545 Background: Quality of life (QoL) is considered to be the true measure for the effectiveness of a surgical pro- cedure, but there are only a few validated instruments available for bariatric surgery.Therefore, a new disease- specific 30-item instrument was created, which was called Bariatric Quality of Life (BQL) questionnaire. Methods: To validate the BQL, we studied 133 patients after 4 different types of bariatric surgery. Initially, mean body mass index (BMI) was 47.2 ±7.6 kg/m2 and mean age was 38.8 ±11.0 years. At base- line, and 1, 6, and 12 months after surgery, patients filled in the BQL, the SF-12 (Short Form of SF-36 Health Survey), the GIQLI (Gastrointestinal Quality of Life Index), and the BAROS (Bariatric Analysis and Reporting Outcome System). Results: Internal consistency of the BQL was found to be good, with Cronbach’s alpha ranging between 0.71 and 0.86. Factor analyses suggested that the BQL included a highly consistent set of QoL items and a second part on co-morbidities and gastrointestinal symptoms. At the 12 months follow-up, the BQL was closely correlated to SF 12 (Pearson’s r = 0.86), GIQLI (0.68), BAROS (0.71), and excess weight loss (0.55). Standardized effect sizes over time were larger for the BQL (1.39 and 1.58) than for the other instruments. Conclusions: The BQL questionnaire is a validated instrument ready for clinical use. Key words: Quality of life, obesity, morbid obesity, psy- chology, questionnaires, validation study, bariatric surgery Introduction As surgery is the most effective treatment for mor- bid obesity, there is growing interest on assessing health-related quality of life (QoL) in these patients.1,2 Generic instruments, such as the SF-36 (Short Form 36), have difficulties in grasping all important obesity-related QoL issues.3,4 Currently, several validated disease-specific instruments are available to measure QoL in obese persons.5-8 These instruments were primarily intended to describe patients who are under no or only conservative treat- ment. Consequently, the instruments include global and obesity-related domains, but fail to analyze sur- gery-related problems. Since gastrointestinal (GI) side-effects commonly impair QoL after bariatric surgery, the sole assessment of obesity-related prob- lems would mean looking only at the benefits of weight loss, while turning a blind eye to the harms caused. Accordingly, many obesity surgeons use symptom specific questionnaires, especially the Gastrointestinal Quality of Life Index (GIQLI),9,10 in addition to an assessment of obesity-related QoL. A further important QoL issue in the obese patient is the ameliorization of co-morbidities. Many of the available instruments were not specifically designed for the morbidly obese patient who undergoes weight loss surgery. In consequence, the standard instruments did not assess co-morbidities, because these instruments were validated either in patients who never had obesity-related co-morbidities or in patients who had co-morbidities but never received The Bariatric Quality of Life (BQL) Index: A Measure of Well-being in Obesity Surgery Patients Sylvia Weiner, MD1; Stefan Sauerland, MD, MPH2; Martin Fein, MD1; Rafael Blanco, MD3; Ingmar Pomhoff, MD3; Rudolf A. Weiner, MD3 1Obesity Academy Frankfurt e. V., Frankfurt, Germany; 2Biochemical and Experimental Division, Medical Faculty, University of Cologne, Germany; 3Department of Surgery, Sachsenhausen Hospital, Frankfurt, Germany Reprint requests to: Sylvia Weiner, MD, Obesity Academy Frankfurt e. V., Eschersheimer Landstr. 248, 60320 Frankfurt a. M., Germany. Fax: ++49 (0) 69 956 36 41 0; e-mail: sylvia.weiner@gmx.de a treatment of sufficient efficacy for improvement of co-morbidities. Only two QoL measures are currently well- accepted: The BAROS (Bariatric Analysis and Reporting Outcome System)11 and the IWQoL (Impact of Weight on Quality of Life).12 The BAROS assigns point scores to medical events (e.g. EWL, reoperation) and QoL data, as measured with the Moorehead-Ardelt QoL questionnaire (M-A QoLQ I).13 Although the first version of the BAROS has never been validated and can only be adminis- tered after surgery, it is commonly used.14 Only recently, therefore, a revised version has been devel- oped (M-A QoLQ II) and validated to overcome the shortcomings of the first version.14 The recently shortened version of the IWQoL with 31 items, cur- rently appears to be another very good QoL measure for obesity surgery patients. Its psychometric prop- erties have been extensively tested,8,15-18 but it fails to assess GI symptoms which are common after obesity surgery. We therefore set out to develop a new short instrument that measures QoL in relation to weight, weight-related co-morbidity, and surgery- related GI symptoms. Patients and Methods Questionnaire Development In the pilot phase, 50 patients were given two ques- tionnaires, the SF-36 and the BAROS.19 All patients were asked to provide comments on the usefulness of the different items and suggest further issues. Based on these suggestions and comments of various sur- geons on face validity, questionnaire items were for- mulated to generate a new instrument for the assess- ment of Bariatric Quality of Life (BQL). Relying on these data, a new questionnaire was tested on 110 patients and adapted again (Figures 1 and 2).The 19- item selection was based on the conceptual rationale that the following domains should be addressed: psy- chological well-being, social functioning, physical functioning, and problems and symptoms related to obesity surgery and obesity-related co-morbidity. BQL scores can range between 0 and 78 points, with lower scores denoting worse results. Patients With this new instrument, we studied three different populations. The first group consisted of 133 bariatric surgery patients (Table 1). This cohort was The Bariatric Quality of Life (BQL) Index Obesity Surgery, 15, 2005 539 Do you suffer from: vomiting...................................... Yes o0 No o0.5 sour belching.............................. Yes o0 No o0.5 heartburn.................................... Yes o0 No o0.5 nausea....................................... Yes o0 No o0.5 diarrhea...................................... Yes o0 No o0.5 flatulence (gassing)..................... Yes o0 No o0.5 foul-odor feces........................... Yes o0 No o0.5 bladder problems / urinary incontinence.................. Yes o0 No o0.5 hair loss..................................... Yes o0 No o0.5 gallstones (or gallbladder removed)........... Yes o0 No o0.5 diabetes..................................... Yes o0 No o0.5 high blood pressure / hyper- tension (also if treated).............. Yes o0 No o0.5 asthma / sleep apnea................ Yes o0 No o0.5 arthrosis / joint pain................... Yes o0 No o0.5 gout............................................ Yes o0 No o0.5 others: ______________________________________ Do you take any medication regulary?...................................Yes o0 No o0.5 If yes, what kind of medication do you take? - antidiabetics.............................. Yes o No o - insulin....................................... Yes o No o - antihypertensives...................... Yes o No o - antidepressants......................... Yes o No o - appetite suppressants............... Yes o No o - diuretics.................................... Yes o No o - pain killers................................. Yes o No o others: _______________________________________ Figure 1. The Bariatric Quality of Life (BQL) questionnaire (part 1). Please note that only the German version of the BQL was validated within this study. Weiner et al 540 Obesity Surgery, 15, 2005 selected from a consecutive series of 321 operated patients. We excluded those cases in whom BQL data was missing for more than one of the three major time points (at baseline and after 6 and 12 months). Missingdata were caused either by loss to follow-up or by the fact that surgery was <1 year ago. Mean age was 38.8 (SD ±11.0) years. To increase the generalizability of results, all four major types of bariatric surgery were considered, although this was a monocentric study. After sur- gery, BMI fell from a baseline mean value of 47.2 kg/m2 (SD ±7.6) down to 36.6 (±6.2) after 6 months and to 33.4 (±5.7) after 12 months. Average %EWL (±SD) increased from 17.3 (±10.3) after 1 month and 30.6 (±12.5) after 3 months to 42.5 (±16.8) and 53.6 (±21.7) after 6 and 12 months. In addition, the BQL was administered to a con- venience sample of 220 healthy volunteers selected from hospital staff and friends (mean age 36.2 years, range 17 to 72). A third group consisted of 40 patients who were hospitalised in the wards of the division of general surgery at the University of Wuerzburg and were willing to fill in the questionnaires. The patients were mainly trauma patients or admitted to hospital because of general surgical indications (e.g. appen- dicitis, gallstones, etc). These clinically stable patients (mean age 50, mean BMI 24.4) were sur- veyed twice within a 48-hour period in order to inves- tigate the test-retest reliability of the BQL. QoL Assessments As recently recommended,20 we based our QoL assessments on a combination of generic and specific instruments. However, we were unable to administer the IWQoL, because no German version was avail- able at the start of this study. As collateral QoL meas- ures we therefore used the SF-12 (a shortened version of the SF-36),21 a translated version of the BAROS,11 and the GIQLI, which has been validated in English and German.9,10 All questionnaire results were stan- dardized on a 0 100 percentage scale. Statistical Analysis In compliance with general psychometric stan- dards,22,23 we examined the conceptual model, reli- ability (including internal consistency), validity (cri- terion and construct related), and responsiveness 1. I like my weight. o1 o2 o3 o4 o5 absolutely wrong half/half true absolutely wrong right 2. I can accept my weight. o1 o2 o3 o4 o5 absolutely wrong half/half true absolutely wrong right 3. How is your actual quality of life? o1 o2 o3 o4 o5 very bad bad OK good very good 4. I exercise regularly. o1 o2 o3 o4 o5 absolutely wrong half/half true absolutely wrong right 5. I am participating in social activities (theatre, etc.). o1 o2 o3 o4 o5 absolutely wrong half/half true absolutely wrong right 6. I often meet friends or family. o1 o2 o3 o4 o5 absolutely wrong half/half true absolutely wrong right 7. I feel excluded from social life. o1 o2 o3 o4 o5 absolutely wrong half/half true absolutely wrong right 8. I feel under pressure because of my weight. o1 o2 o3 o4 o5 absolutely wrong half/half true absolutely wrong right 9. Sometimes, I feel depressed. o1 o2 o3 o4 o5 absolutely wrong half/half true absolutely wrong right 10. All in all, I feel satisfied in my life. o1 o2 o3 o4 o5 absolutely wrong half/half true absolutely wrong right 11. I feel restricted because of my weight. a) at home o1 o2 o3 o4 o5 absolutely wrong half/half true absolutely right wrong a) at work o1 o2 o3 o4 o5 absolutely wrong half/half true absolutely right wrong a) privately o1 o2 o3 o4 o5 absolutely wrong half/half true absolutely right wrong 12. I feel self-confident. o1 o2 o3 o4 o5 absolutely wrong half/half true absolutely wrong right Figure 2. The Bariatric Quality of Life (BQL) question- naire (part 2). The Bariatric Quality of Life (BQL) Index Obesity Surgery, 15, 2005 541 (i.e. sensitivity to change) of the BQL. Standard statistical tests (Student’s t-test and analysis of variance) were used for groupwise com- parisons of continuous data. Cronbach's alpha was calculated to determine the internal consistency of the BQL total and subscale scores. Pearson's corre- lation coefficient was used to examine the relation- ship between BQL scores and other QoL instru- ments as well as weight related parameters. For the quantification of test retest reliability, we calculated relative differences and constructed a Bland-Altman plot.24 To analyze the structure of the BQL, factor analyses were performed without rotation. Factor analyses were repeated for the 6- and 12-month fol- low up examination. We extracted eigenvalues >1, in order to describe the different subdomains of the BQL (i.e. principal component analysis). The size of an eigenvalue describes how much variation among the original data that this factor explains. As measures of internal responsiveness, standard- ized effect sizes were calculated by dividing the dif- ference between two means (e.g. at baseline and after 1 year) by the total group standard deviation. Effect sizes >0.8 represent large changes.25 Significance was defined by a threshold of P< 0.05. Results Reliability Test retest reliability was good with an average vari- ation of 8.3 points (14.2%). There was no difference between the results of the first and second test administration, with a mean difference of 0.75 points. The Bland-Altman plot failed to show any problems in test repeatability, although variation was smaller when BQL scores were nearly normal (i.e. 78 points). Among obese patients, the mean (±SD) preoperative BQL score reached only 41.6 (±10.5) points, which was significantly lower than the scores among healthy volunteers (65.3 ±7.2) and other hospital patients (60.0 ±9.2). The results on healthy volunteers are shown in Table 2. Internal consistency of the BQL was found to be good, with Cronbach's alpha ranging between 0.71 and 0.86 at the different time points (Table 3). As expected, the QoL subscale of the BQL was more consistent (range 0.80 to 0.93) than the remaining 16 items on co-morbidity and side-effects (range 0.55 to 0.69). The SF-12 displayed perfect consis- tency with Cronbach's alpha between 0.84 and 0.91, whereas the GIQLI and the BAROS were less con- sistent. The QoL subscale of the BAROS was also Table 1. Patient characteristics LAGB VBG RYGBP BPD Total P-value Number of patients 55 6 49 23 133 n.a. Females (proportion) 48 (87%) 4 (66%) 39 (80%) 17 (74%) 108 (81%) 0.39a Age (years) 37.6 ±12.2 38.2 ±14.8 41.6 ±10.4 36.1 ±7.0 38.8 ±11.0 0.16b Preoperative BMI (kg/m2) 44.3 ±6.2 43.9 ±5.2 48.3 ±7.5 52.5 ±7.9 47.2 ±7.6 <0.001b Data are means ± standard deviations or counts with percentages. aby chi-square test bby analysis of variance Table 2. Results obtained in a convenience sample of healthy volunteers BMI <25 BMI 25-30 BMI >30 P-value Number of persons 159 48 13 n.a. Females (proportion) 110 (69%) 19 (40%) 9 (69%) 0.001a Age (years) 34.0 ±12.5 41.7 ±14.3 43.1 ±13.2 <0.001b BMI (kg/m2) 21.6 ±1.9 26.6 ±1.2 32.6 ±2.9 <0.001b BQL (%) 84.6 ±9.0 83.1 ±8.9 75.8 ±8.6 0.003b For explanations, see footnote of Table 1. Weiner et al 542 Obesity Surgery, 15, 2005 less consistent than its BQL counterpart. Of note, consistency results for the GIQLI and also for the non-QoL subscale of the BQL improved in parallel to increasing lengths of follow-up. Principal Component Analysis Analysis of the 6-month data showed that 9 factors with eigenvalues >1 were necessary to describe answer patterns. We decided to extract only 3 factors with eigenvalues of 7.2, 2.6 and 2.0, thus explaining 39.4% of total variance. The factor structure is shown in Table 4. Similarly, examination of the eigenvalues and the scree plot for the 12-month data indicated that a 3-factor solution may be appropriate, because these factors accounted for 44.3% of the total variance. Eigenvalues of the three factors were 8.6, 2.5, and 2.1. However, there were seven further factors with eigenvalues between 1.7 and 1. Factor structure was stable over time, but three items (biliary symptoms, loss of hair, and sporting) did not load on any of the main factors. The first and strongest factor with 13 loading items denotes general QoL, while the second and third factor quite consistently measure co-mor- biditiesand GI side-effects. Construct Validity Good correlations between the BQL and the other instruments indicated a high construct validity for the BQL. At baseline, BQL scores were highly cor- related to the SF-12 (r= 0.79; P<0.0001), but the cor- relation with the GIQLI was questionable (r= 0.13; P=0.28). Six months after surgery, highly significant correlations between the BQL and the SF-12 (r= 0.79), the GIQLI (r= 0.64), and the BAROS (r= 0.52) were observed. Similar coefficients were calculated for the 1-year follow-up data (0.86, 0.68, and 0.71). The correlation between EWL over time and QoL instruments is shown in Table 5. High BMI before surgery was associated with high scores on the BQL (r= 0.26, P=0.01) and the SF-12 (r= 0.26, P<0.01), but not on the GIQLI (r= 0.10, P=0.38). BMI after 6 months was closely connected to the BQL (r= 0.40) and the BAROS (0.47), rather than to the SF- 12 (0.32) and the GIQLI (0.22). These correlations to BMI improved over time, with coefficients of 0.48 and 0.46 for BQL and BAROS, and 0.37 and 0.33 for SF-12 and GIQLI after 1 year. Sensitivity to Change The comparison of scores between baseline and the 1-year follow-up showed a larger effect size for the BQL (1.58) than for the SF-12 (1.14) or the GIQLI (1.00). However, the biggest effect size of surgery was that on BMI (2.12). At 6 months after surgery, similar results were already apparent for the BQL (1.39), the SF-12 (1.04), the GIQLI (0.91), and BMI (2.24). When comparing BQL scores among patients with EWL ≥50% (n= 64) versus <50% (n= 39), an effect size of 1.20 was calculated. This again com- pares well with the BAROS (1.01), the GIQLI (0.86), and the SF-12 (0.76). Even in the normal population (n= 220), mean BQL scores differed between normal weight, overweight, and obese persons (Table 2). The frequency distribution for most of the BQL items showed no evidence of ceiling or floor effects. Some co-morbidities were found to be quite rare (i.e. <10% prevalence) at the 6 and 12 month fol- Table 3. Internal consistency of the difference instruments over time (Data represent Cronbach's alpha or countages) Number of items at baseline after 1 month after 6 months after 12 months Number of patients 100 61 122 106 BQL 30 0.790 0.712 0.809 0.857 QoL subscale 14 0.892 0.801 0.898 0.932 non-QoL subscale 16 0.548 0.620 0.690 0.654 SF 12 12 0.882 0.835 0.892 0.913 GIQLI 36 0.686 0.774 0.880 0.854 BAROS 9 n.a. n.a. 0.622 0.710 QoL subscale 5 n.a. n.a. 0.785 0.848 non-QoL subscale 4 n.a. n.a. 0.387 0.466 The Bariatric Quality of Life (BQL) Index Obesity Surgery, 15, 2005 543 low-up: heartburn (13 and 12 cases, respectively), urinary incontinence (7 and 5), biliary symptoms (7 and 4), diabetes (8 and 6), pulmonary problems (13 and 9), osteoarthritis (3 and 1). However, they were not rare at the preoperative assessment, thus justify- ing their inclusion in the BQL. Discussion We have developed a new instrument, the BQL, to assess QoL together with co-morbidities and GI problems. We have shown that the BQL question- naire is valid, reliable, and responsive. Although this was not formally examined, our experience suggests that the BQL is also very practical and user-friendly. Filling out the questionnaire takes about 10 minutes, and none of the patients refused to fill it out. Our validation study used the German BQL version, but from our initial experience with foreign patients, we also can recommend the English version for clinical use. Although we also found a significant difference between obese and normal weight persons in the control group, it should be noted that the BQL was Table 4. Results of factor analysis with communalities for the BQL data at 6- and 12-month follow-up Item 6 months after surgery 12 months after surgery Factor 1 Factor 2 Factor 3 Factor 1 Factor 2 Factor 3 Vomiting -.306 .457 .296 -.351 .305 .484 Acid reflux -.257 .510 -.139 -.104 -.126 .637 Heartburn -.320 .282 -.113 -.172 .218 .638 Nausea -.150 .433 .022 -.384 .482 .176 Diarrhea -.095 .555 -.116 -.272 .522 .182 Flatulence (gassing) -.242 .617 -.055 -.370 .447 .163 Foul-odor feces -.346 .447 -.150 -.302 .415 .026 Urinary incontinence -.462 .123 -.053 -.364 .398 -.133 Hair loss -.033 .200 -.223 -.043 .104 .170 Gallstones -.160 .213 -.020 .011 .170 .076 Diabetes -.140 .134 .507 -.253 -.035 -.000 Hypertension -.234 .232 .611 -.224 .172 -.242 Asthma/sleep apnea -.292 .452 -.095 -.226 .555 -.103 Arthrosis -.187 -.014 .495 -.254 .608 -.026 Gout -.412 .084 .111 -.283 .408 -.260 Medication -.431 .085 .519 -.296 .081 -.526 Weight satisfaction .672 .342 -.211 .749 .291 -.274 Acceptance of weight .623 .392 -.265 .696 .295 -.355 Quality of life .751 .009 .023 .809 .090 -.171 Sports .266 -.169 -.261 .351 -.083 .123 Exercise .586 .092 -.202 .718 .032 .282 Social activities .644 -.025 -.120 .622 .008 .359 Feeling excluded .511 .082 .207 .704 .152 .097 Under pressure .653 .363 -.090 .741 .312 -.177 Depressed .668 .007 .257 .688 .135 .119 Life satisfaction .763 -.017 .143 .856 .092 .018 Restriction at home .686 .082 .252 .789 -.014 .089 Restriction at work .701 .140 .360 .766 .172 .081 Restriction in privacy .761 .162 .269 .858 .087 .071 Self-confidence .692 .189 .080 .756 .190 .090 Salient factor loadings (i.e. values >0.40) are marked in bold. Table 5. Association among different psychometric indices and excess weight loss (EWL) after 6 and 12 months (All values are Pearson’s correlation coeffi- cients; all correlations were significant at the 0.001 level) EWL after 6 months EWL after 12 months BQL 0.458 (n= 110) 0.553 (n= 103) BAROS 0.619 (n= 83) 0.586 (n= 86) GIQLI 0.411 (n= 100) 0.406 (n= 95) SF-12 0.392 (n= 110) 0.421 (n= 103) Weiner et al 544 Obesity Surgery, 15, 2005 not intended to examine obesity-related QoL in the normal population. Furthermore, the BQL can aid surgeons in selecting patients for bariatric surgery, but its main purpose is to assess postoperative patient outcomes. Internal consistency values for the BQL exceeded the threshold that is required for good consistency, but the factor structure of the BQL was heteroge- neous. Nevertheless, we have to keep in mind that the BQL contains two parts dealing with different domains. It was anticipated that some of the co-mor- bidity items (e.g. loss of hair) were quite independ- ent of GI problems and weight loss. Therefore, we decided not to change the instrument, even if inter- nal consistency for this part of the questionnaire was clearly lower than for the directly QoL related items. It also may be helpful for other purposes to have different self-reported items on co-morbidity. Our study has several limitations. First, the test- retest reliability was examined only in a patient sample that did not undergo obesity surgery. Secondly, as in any study like this, no true gold stan- dard was available to define the QoL construct for bariatric surgery patients. We believe that BQL includes all major aspects of QoL, but this cannot be proven. Those researchers who think that a more detailled assessment of eating behavior or psycho- logical functioning is necessary should supplement the BQL with other specific instruments.26-29 One of the advantages of our study is the large patient sam- ple, which we surveyed at more than just two time points. An additional advantage is the inclusion of all major types of bariatric procedures in the study, because each of the procedures may lead to specific problems from the surgical, gastrointestinal, or nutritional point of view. When comparing BQL and BAROS, it is no sur- prise that the BAROS was more closely correlated to EWL, because an EWL point score is part of the BAROS. Furthermore, it is very possible that those operations which produced greater weight loss also caused more GI side-effects. This inverse relation- ship between GI symptoms and EWL might have compromised the results for the BQL, whereas the BAROS remains unaffected. However, it is essential also to measure the presence and severity of such problems. Focussingonly on EWL would be a too simplistic approach to bariatric surgery.30 Furthermore, it is interesting to compare different time points, because the impact of GI problems is probably higher, the longer the follow-up lasts. Preoperatively such problems are usually mild, but once weight loss has reached a plateau phase, QoL will be strongly influenced by such symptoms. Our results strengthen this hypothesis, because we observed better consistency of BQL and GIQLI with increasing duration of follow-up, whereas SF- 12 results were similar over time. On the other hand, the time course of co-morbid conditions must also be considered, even if some of these co-morbidities are relatively rare. This heterogeneity of coexistent illnesses makes it difficult to reduce the number of questions in the BQL. As we considered it important to cover all aspects of obesity, we left the first part of the BQL unchanged. By using a yes-or-no format for these items rather than a likert scale, the BQL can still be filled in very quickly. Studies dealing with side-effects could additionally use the GIQLI, because this instrument allows a more detailled assessment of the severity of GI symptoms.31 The clearest advantages of the BQL were found when looking at responsiveness. It was expected that the BQL exhibited better sensitivity to change than the SF-12, because a disease-specific instru- ment usually is more responsive than a generic instrument.6,32 High responsiveness is crucial when selecting an instrument as a outcome measure in a clinical trial. In this regard, using the BQL in future studies would allow researchers to find significant results with smaller sample sizes. 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