Measuring Sensitivity to Nonignorability
Primary Purpose
Cardiovascular Diseases, Heart Diseases
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by

About this trial
This is an observational trial for Cardiovascular Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00037362
First Posted
May 16, 2002
Last Updated
July 28, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00037362
Brief Title
Measuring Sensitivity to Nonignorability
Study Type
Observational
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
August 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief Summary
To develop a new statistical index that measures sensitivity to non-ignorability (index of sensitivity to nonignorability, or ISNI) for model-based inferences.
Detailed Description
BACKGROUND:
Despite a considerable number of recent developments, missing data and associated methodology continues to be an important topic of research in biostatistics, medicine and public health. As investigators begin to understand the limitations of model-based inferences under the assumption of non-ignorable missingness, recent attention has turned to the formulation and implementation of sensitivity analyses. Having a general-purpose index to assess sensitivity to departures from ignorability would be extremely useful to researchers in a variety of fields in the health sciences. This is especially true if the index is relatively easy to compute and interpret.
DESIGN NARRATIVE:
It would be useful to have a general, easily computed diagnostic that characterizes data sets with respect to their potential for sensitivity to nonignorability. The investigators have developed a diagnostic that measures the effect of small perturbations from ignorability on coefficient estimates in the univariate linear model with missing observations.They will extend their analysis in a number of directions: i) They will develop a general class of diagnostics for Bayes and direct- likelihood inferences, and demonstrate its application to a number of important special cases. ii) They will develop an analogous theory for sensitivity to nonignorability in frequentist estimation and testing. iii) They will develop a general form of the diagnostic for the coarse-date model, a generalization of missing data that includes censoring and rounding as special cases. iv) They will analyze a number of real- world data sets that represent important cases where nonignorability is of interest, including dropout in longitudinal data, censored survival data, and cross-over in clinical trials.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Heart Diseases
7. Study Design
10. Eligibility
Sex
Male
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Heitjan
Organizational Affiliation
Columbia University Health Sciences
12. IPD Sharing Statement
Citations:
PubMed Identifier
15909292
Citation
Ma G, Troxel AB, Heitjan DF. An index of local sensitivity to nonignorable drop-out in longitudinal modelling. Stat Med. 2005 Jul 30;24(14):2129-50. doi: 10.1002/sim.2107.
Results Reference
background
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Measuring Sensitivity to Nonignorability
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