OPEN Research Support
head

PhD-student
Lotte Poulsen
Department of Plastic Surgery, Odense University Hospital


Projekt styring
Projekt status    Sampling ongoing
 
Data indsamlingsdatoer
Start 01.02.2015  
Slut 01.02.2021  
 



Validation of The Body-Q in Denmark - a new Patient-Reported Outcome Measure

Short summary

The study is a cohort study on patient-reported outcome in bariatric and body contouring surgery. We aim to identify patients' expectations, quality of life and behavioral change following bariatric and body contouring surgery and to test an international patient-reported outcome measure (BODY-Q) in the Danish context.


Rationale

Obesity is a global epidemic that is linked to a range of health problems including diabetes, cardiovascular disease, depression and some forms of cancer. In Denmark, 47% are considered overweight. Bariatric and body contouring surgery are in Denmark available in the public system within sudden criteria including body mass index (BMI) and amount of excessive skin following weight loss. Weight loss can be induced by several methods including diet and exercise, but bariatric surgery has been shown to be the most effective therapy available for weight loss in moderately and severely obese people. Bariatric surgery promotes weight loss by surgically reducing stomach size to restrict food intake. In addition to lowering body weight, bariatric surgery can improve or resolve a range of obesity-related conditions, e.g., type 2 diabetes, heart disease, sleep apnoea, hypertension and high cholesterol. In Denmark, in the period 2006-2014, approximately 15.800 bariatric procedures have been performed.

The surgical treatment of severe obesity seems to create both success and distress. Several studies have shown cost-effectiveness and improvement of Quality of Life after gastric bypass and furthermore several qualitative studies describe the impact of bariatric surgery on the patient's life. These studies reveal that bariatric surgery can lead to emotional and social changes with following imbalance in family and other relationships.

Studies investigating the correlation between the body contouring procedures and impact on quality of life are in general few. In earlier publications outcome data regarding body contouring and quality of life have been reported, however few had a longer follow up period. Some studies have indicated an effect of body contouring on physical, mental and social quality of life, and recently two important long term follow up studies have been published, demonstrating significant improvement of quality of life in the group with body contouring in comparison to those who had only gastric bypass. Furthermore, a qualitative study has recently been published, describing that the removal of skin leads to improvements in a patient's appearance and enhanced physical, psychological, and social health and well-being. It is concluded that, a well-developed psychometrically sound patient-reported outcome instrument is needed. There are no Danish studies investigating the general assumption, that body contouring following massive weight loss might improve quality of life.

Since 2010 in Denmark, all patients undergoing bariatric surgery have been registered in the Danish Bariatric Surgery Database. The database has 8 indicators including complications data, weight loss data and effect on comorbidity. The database also searches, physical and psychological improvements. Currently the Moorehead Ardelt Quality of Life Questionnaire (MAQOL) is being used to collect data according to quality of life in both bariatric and body contouring patients. The MAQOL has several limitations including content validity for the body contouring patients as it 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. Other important limitations are the total score and that the questionnaire has not been designed to measure change in the overall weight loss journey. It is clear, that the MAQOL only has been implemented for body contouring patients in the absence of a better instrument at the time, and overall that a better instrument is needed in order to collect reliable data concerning change in quality of life. 


Description of the cohort

All patients referred to bariatric and body contouring surgery in the Region of Southern Denmark will be included. Participants will be asked to fill out the questionnaire at different points in the patient journey:

  • Pre bariatric surgery
  • 4 months post bariatric surgery
  • 12 months post bariatric surgery
  • Pre body contouring surgery
  • 3 months post body contouring surgery
  • 12 months post body contouring suregery
Eligible participants will include male and female patients, aged 18 years of age or older and being pre-bariatric surgery, post-bariatric surgery, pre-body contouring surgery or post-body contouring surgery. Exclusion criteria are inability to speak or understand Danish.



Data and biological material

As mentioned above, the study is a cohort study on patient-reported outcome in bariatric and body contouring patients. Participants will fill out the BODY-Q questionnaire via REDcap. 


Collaborating researchers and departments

Department of Plastic Surgery, Odense University Hospital 

  • PhD-student Lotte Poulsen
  • Professor and main supervisor Jens Ahm Sørensen, PhD

the Institute of Psychology, University of Southern Denmark

  • Professor and Co-supervisor Kirsten Kaya Roessler, PhD

Department of Surgery, Section of Plastic Surgery, Sydvestjysk Sygehus, Esbjerg

  • Consultant and Co-supervisor Michael Rose

The Faculty of Health Sciences at McMaster University, Canada
  • Associate Professor and Co-supervisor Anne Klassen