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临床试验/NCT05272215
NCT05272215Unknown不适用

Longitudinal Follow-up and Comparison of Bariatric and Post-bariatric Body Contouring Patient's Health-related Quality of Life Relative to Population Norms Using the BODY-Q

Odense University Hospital1 个研究点 分布在 1 个国家目标入组 20,000 人开始时间: 2015年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
20,000
试验地点
1
主要终点
BODY-Q Health-related quality of life (HRQL) domain

研究概览

简要总结

Obesity is a global epidemic that has nearly tripled since 1975. Worldwide, over 650 million people live with obesity, and it is therefore a growing cause for concern. Bariatric surgery (BaS) is the most effective long-term weight loss method in morbidly obese patients. BaS can result in sustained weight loss and resolve obesity-related comorbidities. However, BaS most often results in various extremes of excess skin, where subsequent body contouring surgery (BC) can be needed. The excess skin following massive weight loss is known to negatively impacts patients' body image, physical and psychological well-being, which previous studies have indicated to improve after BC.

The purpose of this study is to assess change in patients' health-related quality of life (HRQL) relative to the general population score. To the best of our knowledge, there are no studies measuring change of patient's HRQL throughout the entire weight loss journey and comparing these scores with the scores of the general population.

It is hypothesized that 1) BaS will improve patients' quality of life on short terms (1-2 years) after surgery, however patients' HRQL will decrease with increasing amounts of excess skin. 2) Patients' HRQL will improve after post-BC equivalent of the scores of the general population.

详细描述

HRQL is best measured through patient-reported outcomes (PRO), defined as a patient evaluation of outcomes without interference from clinicians or any other intermediary. A vast array of patient-reported outcome measure (PROM)s have been used in weight loss and BC patients, many of which do not possess strong evidence of reliability and validity for the patient population.

In 2016, The BODY-Q, a condition-specific PROM developed following internationally recommended guidelines to measure PRO in weight loss, including bariatric surgery, and body contouring surgery (BC) patients were introduced. It consists of 32 independently functioning scales measuring four domains: appearance, HRQL, eating-related concerns, and patient experience of care. It is rigorously tested to ensure content validity, reliability, and responsiveness. Due to the strongest evidence for validity and its psychometric properties, recent systematic review based on the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) methodology only recommend the BODY-Q for use in this patient population.

The BODY-Q has been shown to be responsive to change and subsequently to measure change over the entire weight loss trajectory, i.e., from obesity to weight loss with or without BC. In previous studies, the BODY-Q has been used to demonstrate the efficacy of weight loss therapy and BC.

However, a current limitation of the BODY-Q is the lack of general population norms as a reference value of the four domains (HRQL, appearance, eating-related concerns, and experience of care). To date, it is not known how published preoperative and postoperative scores compare to population norms, enabling a better understanding of HRQL of obesity and change through the weight loss trajectory.

The primary aim of this study is to investigate the change of HRQL through the entire weight loss journey from obesity to post-BC in a longitudinal, prospective cohort study of Danish patients. The study will be performed as part of an international collaboration and Danish data will be merged with data from the Netherlands, Finland, Poland, Italy, Germany, and the United States. The secondary aim of this study is to compare international patient results with the general population norms. The general population norms. Currently, the general population norms study is under submission.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Pre- and post-bariatric surgery patients
  • Pre- and post body contouring surgery patients
  • Fluent in Danish

排除标准

  • Patients who do not speak Danish
  • Patients with cognitive impairments
  • Patients who have not undergone BaS/BC

结局指标

主要结局

BODY-Q Health-related quality of life (HRQL) domain

时间窗: June 2015 to May 2022

Following scales are included: 1. Appearance distress 2. Body image 3. Physical function 4. Physical symptoms 5. Psychological 6. Sexual 7. Social 8. Work life

次要结局

  • Comparison of patient scores to general population normative scores(June 2015 to May 2022)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Farima Dalaei

MD

Odense University Hospital

研究点 (1)

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