REAL WORLD EVIDENCE (RWE) _AN

INDIAN PRESPECTIVE

- RWE working group (2021 – 2022)

STUDY REPORT
 Study report
Title and Abstract
Introduction
Methodology
Data Collection
Statistical Method
Bias and Confounding factors
Result
Discussion
 Introduction
RWE studies,
• Clinical effectiveness and safety of medical product.
Limited number of accepted principles for evaluation and interpretation.
• Need of transparency and reproducibility.
Reproducible research is recognized in many reporting guidelines,
• STROBE – “Strengthening the Reporting of Observational Studies in Epidemiology”.
• RECORD – “REporting of studies Conducted using Observational Routinely collected Data”.
• GRACE – “Good ReseArch for Comparative Effectiveness”.
ISCR recommended for the content of the report(s) to consider,
• Good Pharmacoepidemiology Practices (GPP)
• STROBE
• RECORD
 STUDY REPORT
1.Title and Abstract:
Title Page
Title
Name, degrees, address and Affiliation of PI and Co-I.
Name and address of the sponsor
Time frame of the study
Abstract
Informative and balanced summary. 2. Introduction:
Background and rationale.
Study’s Objective.
Purpose of finding new relationship of data (or)
Purpose of testing one or more hypothesis.
 3. Methodology
Design
• Study plan
Disease / Condition
• diagnostic certainty, severity, significant co-morbidities, treatment history.
Population
• Population characteristics.
Comparators
• Unrealistic – consider all intervention instead of single comparator.
 Variables
• Outcomes , exposures, Outcome measures (endpoint).
Setting
• The setting, locations, and relevant dates.
 STUDY REPORT
5. Statistical Method:
How?
• populations, interventions, and outcomes
• missing data
• Outliers
• Unmeasured confounders
analytic approaches
Data cleaning methods.
4. Data Collection:
How? Methods used to examine subgroups and

Quality interactions.

Validity of conclusion
 6. Bias and Confounding Factors
Selection Bias
• Systematic differences among the groups being compared.
Misclassification Bias
• occurs when an exposure is incorrect or missing.
Detection Bias
• comparison groups are assessed at different points in time or using different methods or by assessors.
Performance Bias
 Refers to systematic differences in care other than the intervention under study.
Attrition Bias
• refers to selective loss to follow-up.
 7. Result:
The number of individuals screened.
Superficial evidence that the study procedures were implemented correctly.
Final analyzable sample.
Sufficient tables, graphs, and illustrations which reflect the analyses performed.
Both unadjusted and adjusted results.
Statistical techniques like propensity score methods and instrument variable methods.
Absolute measures of effect.
• proportions, means, rates, number-needed-to-harm (NNH), number-needed-to-treat-to-harm (NNTH) and
number-needed-to-treat (NNT).
Relative measures of effect.
• odds ratios (ORs), incidence rate ratios, relative risks, and hazard ratios (HR).
 8. Discussion:
The implications of using data that were not created or collected
to answer the specific research question(s) should be discussed.
Discussion related,
• major protocol deviations.
• misclassification bias
• unmeasured confounding
• missing data
• changing eligibility over time
A statement of the conclusions drawn from the analyses of the
data.