Manraj Nirmal Kaur

The BODY-Q: A Patient-Reported Outcome Instrument for Weight Loss and Body Contouring Treatments

Background: Body contouring performed for cosmetic purposes, or after weight loss, has the potential to improve body image and health-related quality of life (HRQL). The BODY-Q is a new patient-reported outcome (PRO) instrument designed to measure patient perceptions of weight loss and/or body contouring. In this article, we describe the psychometric properties of the BODY-Q scales after an international field-test. Methods: Weight loss and body contouring patients from Canada, United States, and United Kingdom were recruited between November 2013 and February 2015. Data were collected using an iPad directly into a web-based application or a questionnaire booklet. Rasch measurement theory analysis was used for item reduction and to examine reliability, validity, and ability to detect change. Results: The sample included 403 weight loss and 331 body contouring patients. Most BODY-Q items had ordered thresholds (134/138) and good item fit. Scale reliability was acceptable, ie, Person separation index >0.70 for 16 scales, Cronbach &agr; ≥0.90 for 18 of 18 scales, and Test–retest ≥0.87 for 17 of 18 scales. Appearance and HRQL scores were lower in participants with more obesity-related symptoms, higher body mass index, and more excess skin and in those pre- versus postoperative body contouring. The 134 weight loss patients who completed the BODY-Q twice, either 6 weeks (weight loss/nonsurgical body contouring program) or 6 months (bariatric program) later, improved significantly on 7 appearance and 4 HRQL scales. Conclusion: The BODY-Q is a clinically meaningful and scientifically sound patient-reported outcome instrument that can be used to measure outcomes in patients who undergo weight loss and/or body contouring.

A Systematic Review of Surgical Randomized Controlled Trials: Part I. Risk of Bias and Outcomes: Common Pitfalls Plastic Surgeons Can Overcome

Background: The authors investigated the methodological validity of plastic surgery randomized controlled trials that compared surgical interventions. Methods: An electronic search identified randomized controlled trials published between 2000 and 2013. Reviewers, independently and in duplicate, assessed manuscripts and performed data extraction. Methodological safeguards (randomization, allocation concealment, blinding, and incomplete outcome data) were examined using the Cochrane risk of bias tool. Regression analysis was used to identify trial characteristics associated with risk of bias. Results: Of 1664 potentially eligible studies, 173 randomized controlled trials were included. Proper randomization and allocation concealment methods were described in 61 of 173 (35 percent) and 21 of 173 (12 percent), respectively. Outcome assessors were blinded in 58 of 173 (34 percent) trials, and patients were blinded in 45 of 173 (26 percent). Follow-up rates were high, with 99 of 173 (57 percent) randomized controlled trials appearing to have complete follow-up. An intention-to-treat analysis was used in 19 of 173 (11 percent) trials. One-third (58 of 173, 34 percent) did not state their primary outcomes. The most common type of primary outcome used was a symptom/quality of life, class III, outcome (73 of 173, 42 percent). Multinomial regression demonstrated trials reporting an a priori sample size as more likely to have a low risk of bias (p = 0.001). Conclusions: This article highlights methodological safeguards that plastic surgeons should consider when interpreting results of a surgical randomized controlled trial. Allocation concealment, outcome assessor blinding, and patient blinding were identified as areas of concern. Valid and reliable outcome measures are being used in plastic surgery. This analysis provides strong rationale for continued focus on the performance and reporting of clinical trials within our specialty.

A Systematic Review of Surgical Randomized Controlled Trials: Part 2. Funding Source, Conflict of Interest, and Sample Size in Plastic Surgery.

Background: The authors examined industry support, conflict of interest, and sample size in plastic surgery randomized controlled trials that compared surgical interventions. They hypothesized that industry-funded trials demonstrate statistically significant outcomes more often, and randomized controlled trials with small sample sizes report statistically significant results more frequently. Methods: An electronic search identified randomized controlled trials published between 2000 and 2013. Independent reviewers assessed manuscripts and performed data extraction. Funding source, conflict of interest, primary outcome direction, and sample size were examined. Chi-squared and independent-samples t tests were used in the analysis. Results: The search identified 173 randomized controlled trials, of which 100 (58 percent) did not acknowledge funding status. A relationship between funding source and trial outcome direction was not observed. Both funding status and conflict of interest reporting improved over time. Only 24 percent (six of 25) of industry-funded randomized controlled trials reported authors to have independent control of data and manuscript contents. The mean number of patients randomized was 73 per trial (median, 43, minimum, 3, maximum, 936). Small trials were not found to be positive more often than large trials (p = 0.87). Conclusions: Randomized controlled trials with small sample size were common; however, this provides great opportunity for the field to engage in further collaboration and produce larger, more definitive trials. Reporting of trial funding and conflict of interest is historically poor, but it greatly improved over the study period. Underreporting at author and journal levels remains a limitation when assessing the relationship between funding source and trial outcomes. Improved reporting and manuscript control should be goals that both authors and journals can actively achieve.

Health-related quality of life in patients undergoing palmar fasciectomy for Dupuytren's disease.

Background: The present study was undertaken to assess the health-related quality of life in patients with Dupuytren’s disease who undergo palmar fasciectomy. Methods: A prospective cohort of patients with Dupuytren’s disease undergoing palmar and/or digital fasciectomy was recruited from the practice of three plastic surgeons in Hamilton, Ontario, Canada. After written informed consent was obtained, participants were asked to complete three health-related quality-of-life questionnaires (i.e., Short Form-36, Michigan Hand Outcomes Questionnaire, and Health Utility Index Mark 3) at five time points: at 1 week and 1 day preoperatively, and at 1, 3, 6, and 12 months postoperatively. Ranges of motion and grip strength measurement were also recorded. Results: For the 26 patients in the study, the multiattribute scores of the Health Utility Index Mark 3 improved from 0.80 before surgery to 0.83 at 12 months postoperatively (p > 0.05). There was no difference in the Short Form-36 scores, but the Michigan Hand Outcomes Questionnaire scores improved from 74 at 1 week preoperatively to 90 at the 12-month postoperative visit (p < 0.001). Conclusions: Patients who undergo palmar fasciectomy for Dupuytren’s disease experience a substantial improvement in their health-related quality of life 12 months after surgery. In the authors’ study population, a benefit of 0.85 quality-adjusted life-year within 12 months was observed. This can be translated as follows: the average patient who undergoes palmar fasciectomy gains the equivalent of approximately 14.4 days (0.48 months) in perfect health by undergoing palmar fasciectomy. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Measuring utilities of severe facial disfigurement and composite tissue allotransplantation of the face in patients with severe face and neck burns from the perspectives of the general public, medical experts and patients

PURPOSE In an otherwise healthy patient with severe facial disfigurement secondary to burns, composite tissue allotransplantation (CTA) results in life-long immunosuppressive therapy and its associated risk. In this study, we assess the net gain of CTA of face (in terms of utilities) from the perspectives of patient, general public and medical expert, in comparison to the risks. METHODS Using the standard gamble (SG) and time-trade off (TTO) techniques, utilities were obtained from members of general public, patients with facial burns, and medical experts (n=25 for each group). The gain (or loss) in utility and quality adjusted life years (QALY) were estimated using face-to-face interviews. A sensitivity analysis using variable life expectancy was conducted. RESULTS From the patient perspective, severe facial burn was associated with a health utility value of 0.53, and 27.1 QALYs as calculated by SG, and a health utility value of 0.57, and 28.9 QALYs as calculated by TTO. In comparison, CTA of the face was associated with a health utility value of 0.64, and 32.3 QALYs (or 18.2 QALYs years per sensitivity analysis) as calculated by SG, and a health utility value of 0.67, and 34.1 QALYs (or 19.2QALYs per sensitivity analysis) as calculated by TTO. However, a loss of 8.9 QALYs (by SG method) to 9.5 QALYs (by TTO method) was observed when the life expectancy was decreased in the sensitivity analysis. Similar results were obtained from the general population and medical experts perspectives. CONCLUSION We found that severe facial disfigurement is associated with a significant reduction in the health-related quality of life, and CTA has the potential to improve this. Further, we found that a trade-off exists between the life expectancy and gain in the QALYs, i.e. if life expectancy following CTA of face is reduced, the gain in QALY is also diminished. This trade-off needs to be validated in future studies.

Psychometric properties of health-related quality of life instruments in patients undergoing palmar fasciectomy for dupuytren’s disease: a prospective study

BackgroundThe traditional outcome measured following treatment of Dupuytren’s Disease (DD) has been digital range of motion; specifically the gain in digital extension. The outcomes research movement in the last three decades however has been advocating the measurement of outcomes from the patient’s perspective using Health-Related Quality of Life questionnaires (HRQOL). Although several generic and region-specific HRQOL questionnaires exist, there is no guidance as to which one is the most appropriate for this population. The objective of this study is to evaluate the psychometric properties of three self-reported HRQOL outcome measures in patients with DD.MethodsPatients with DD were enrolled from the practices of three plastic surgeons. Test-retest reliability, concurrent validity and responsiveness of three HRQOL questionnaires were compared in a prospective study design. The HRQOL measures included Health Utilities Index Mark 3 (HUI3), Short Form-36 (SF-36), and the Michigan Hand Questionnaire (MHQ).ResultsAll three measures demonstrated good test-retest reliability (ICC = 0.77–0.85). Concurrent validity was found between the HUI3 pain and dexterity attributes and SF-36 physical summary score. The sensitivity of the MHQ to detect changes in the status of the patient was found to be high (effect size = 1.14) whereas that of the SF-36 was trivial.ConclusionsThe HUI3 and the MHQ seem to be reliable and valid tools to assess the HRQOL in patients with Dupuytren’s Disease.

Cost-effectiveness analysis parallel to a randomized controlled trial comparing vertical scar reduction and inverted T-shaped reduction mammaplasty.

Background: A previous randomized controlled trial showed no clear superiority of vertical scar over inverted T-shaped reduction mammaplasty in terms of health-related quality of life. No economic evaluation has been undertaken comparing vertical scar reduction and inverted T -shaped reduction. Methods: A total of 255 patients were randomized to either vertical scar or inverted T -shaped reduction. The effectiveness was measured with the Health Utilities Index Mark 3. Direct and productivity costs were captured parallel to the randomized controlled trial. Perspectives of the Ministry of Health, patient, and society were considered. Results: Inverted T -shaped reduction dominated vertical scar reduction from the Ministry of Health perspective by being slightly less costly (

A Systematic Review of Utilities in Hand Surgery Literature

3090.06 versus

Ulnar hammer syndrome: a systematic review of the literature.

3106.58) and slightly more effective (0.87 quality-adjusted life-years versus 0.86 quality-adjusted life-years). From the societal and patient perspectives, vertical scar reduction was both less costly and less effective. At the commonly quoted Canadian threshold of

Functional outcomes post-radial head arthroplasty: a systematic review of literature

50,000 per quality-adjusted life-year gained, the probability that vertical scar reduction was cost-effective was 29.3, 68.2, and 66.9 percent from the Ministry of Health, patient, and societal perspectives. Subgroup analysis of reductions less than 500 g found that vertical scar reduction was more likely cost-effective. Conclusions: Vertical scar reduction is more likely than not cost-effective from patient and societal perspectives but not from the Ministry of Health perspective at a willingness-to-pay threshold of