NCT02771964|Completed
Assessing Change in Patient-reported Quality of Life After Elective Surgery: an Observational Comparison Study
Assessing Preoperative Falls as a Predictor for Postoperative Surgical Outcomes
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Assessing Preoperative Falls as a Predictor for Postoperative Surgical Outcomes
Sponsor study identifier
Secondary identifiers
observational
17,850
1 country
1
Study Start
January 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2015
Actual (reported)Study Completion
July 2016
Actual (reported)This study will compare two commonly-used methods for assessing patient-reported quality of life. The first is to assess quality of life before surgery and again after surgery using the same validated scale (ie Veterans Rand 12). The second is simply to ask patients whether or not they think their post-operative quality of life is better, worse, or the same. The investigators hypothesize that the second method may be inaccurate due to cognitive bias.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2014
Date type not reportedThis date has not been verified as actual or estimated.
October 2015
Actual (reported)May 11, 2016
Actual (reported)May 13, 2016
Actual (reported)July 2016
Actual (reported)Agreement between self-reported quality of life measurement (better/same/worse) and validated quality of life measurement (Veterans Rand 12 Item Health Survey)
Up to 4 months
Minimum detectable difference in quality of life on the VR-12 scale, using self-reported quality of life (better/same/worse) as the anchor
Up to 4 months
Change in quality of life across surgical specialties, using both the self-reported (better/same/worse) measure and the validated (VR-12) measure
Up to 4 months
All patients receive both types of quality of life assessment, thus serving as their own controls.
All enrolled patients complete a survey of baseline health during their visit to the preoperative assessment clinic and then complete a follow-up survey approximately 30 days after surgery. The intervention for this study is to compare self-reported quality of life ("How would you rate your quality of life now? (better/same/worse)") to the quantitative change in their VR-12 quality of life scores between the baseline survey and 30-day follow-up survey.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The target population is all adult patients undergoing elective surgery at Barnes Jewish Hospital who attend the center for preoperative assessment and planning.
Contact the study team to confirm eligibility.
Department of Anesthesiology
St Louis, Missouri, 63110, United States
Kazis LE, Miller DR, Skinner KM, Lee A, Ren XS, Clark JA, Rogers WH, Sprio A III, Selim A, Linzer M, Payne SM, Mansell D, Fincke BG. Applications of methodologies of the Veterans Health Study in the VA healthcare system: conclusions and summary. J Ambul Care Manage. 2006 Apr-Jun;29(2):182-8. doi: 10.1097/00004479-200604000-00011.
Selim AJ, Rogers W, Fleishman JA, Qian SX, Fincke BG, Rothendler JA, Kazis LE. Updated U.S. population standard for the Veterans RAND 12-item Health Survey (VR-12). Qual Life Res. 2009 Feb;18(1):43-52. doi: 10.1007/s11136-008-9418-2. Epub 2008 Dec 3.
Michael S Avidan, MBBCh
Washington University School of Medicine
17,850 participants (actual enrollment reported by the registry).
First Submitted
May 11, 2016
First Posted
May 13, 2016
Study Start
January 2014
Date type not reportedThis date has not been verified as actual or estimated.
Food as Medicine: An RCT to Study the Effect of Home Delivered, Medically Tailored Meals on Patients With Metastatic Cancer
Norman GR, Sloan JA, Wyrwich KW. Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care. 2003 May;41(5):582-92. doi: 10.1097/01.MLR.0000062554.74615.4C.
Wright A, Hannon J, Hegedus EJ, Kavchak AE. Clinimetrics corner: a closer look at the minimal clinically important difference (MCID). J Man Manip Ther. 2012 Aug;20(3):160-6. doi: 10.1179/2042618612Y.0000000001.
Kronzer VL, Jerry MR, Ben Abdallah A, Wildes TS, McKinnon SL, Sharma A, Avidan MS. Changes in quality of life after elective surgery: an observational study comparing two measures. Qual Life Res. 2017 Aug;26(8):2093-2102. doi: 10.1007/s11136-017-1560-2. Epub 2017 Mar 29.
Primary Completion
October 2015
Actual (reported)Study Completion
July 2016
Actual (reported)Last Updated
February 12, 2019
Record last verified: 2019-01
De-identified data can be provided upon email request.
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Source: ClinicalTrials.gov.
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