NCT02771964

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17,850

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 13, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

February 12, 2019

Status Verified

January 1, 2019

Enrollment Period

1.7 years

First QC Date

May 11, 2016

Last Update Submit

February 11, 2019

Conditions

Quality of LifeSurgical Procedure, Unspecified

Keywords

outcome assessmentpostoperative period

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • 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

Other Outcomes (1)

  • 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

Study Arms (1)

All patients

All patients receive both types of quality of life assessment, thus serving as their own controls.

Other: Quality of life survey

Interventions

Quality of life surveyOTHER

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.

All patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology

St Louis, Missouri, 63110, United States

Location

Related Publications (5)

  • 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.

    PMID: 16552327BACKGROUND

  • 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.

    PMID: 19051059BACKGROUND

  • 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.

    PMID: 12719681BACKGROUND

  • 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.

    PMID: 23904756BACKGROUND

  • 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.

    PMID: 28357679DERIVED

Related Links

Study Officials

  • Michael S Avidan, MBBCh

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesiology

Study Record Dates

First Submitted

May 11, 2016

First Posted

May 13, 2016

Study Start

January 1, 2014

Primary Completion

October 1, 2015

Study Completion

July 1, 2016

Last Updated

February 12, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will share

De-identified data can be provided upon email request.

Locations

US(1)