Research Study Designs Overview

Health Analytics offers a vast range of studies to deliver real-world evidence. Detailed below are the typical uses for the diverse types of research study designs offered by Health Analytics.

Research Study Designs Offered by Health Analytics

As a research centered company, Health Analytics offers a vast range of studies to deliver real-world evidence (RWE). With a diverse range of clientele this requires evaluating various strategies to deliver a final product that concurs with the client’s desired outcome. Different methodologies ensure we effectively address client need and constitutes the blueprint for the collection, measurement, and analysis of data and/or literature. Detailed below are the typical uses for the diverse types of research study designs offered by Health Analytics:

Case Reports and Series

Case reports and series aim to provide an in-depth understanding of complex issues in a real-life setting; a case report describes and interprets a specific incident or case. Case reports can be used to identify new trends or disease (including an important variation of a disease or condition), detect new drug side effects and/or potential uses. To determine whether there is a relationship between relevant factors based on multiple case reports, a case-control study might be the next step.

Systematic Literature Reviews and Meta-Analysis

The aim of a systematic literature review and meta-analysis is to find as much relevant research on a particular research question or topic. Typically, they are used to confirm or refute whether current practices are supported by relevant evidence, assess the quality of that evidence, and identify any gaps in the literature.

Secondary Analysis of Controlled Clinical Trials

Secondary data analysis is leveraged in an attempt to answer a new research question or to examine an alternative perspective on the original question of a previous study (this could be a study that the client has already ran). These are typically used when a secondary perspective is needed.

Prospective Observational Cohort Study

Prospective observational studies provide greater potential to examine a broader range of clinically relevant outcomes. This allows us to track new developments and/or changes regarding disease or treatment among a specific population compared to another group unaffected by the condition or treatment.

Retrospective Cohort Study

Retrospective studies are similar to prospective studies in that they both require examination of a target population over a specific time frame however, retrospective studies are typically conducted after both the exposure and the outcome have already occurred. Because of this, they tend to be completed in a shorter period of time than prospective studies.

NOTE: Deliverables can be customized based on client needs.

Study	Design and Methods	Study Deliverablesα
Case Reports and Series	In-depth investigations into individual patient experiences or a consecutive series of patients presenting for a healthcare encounter.	- IRB Approved Study Protocol - Final Report - Executive Summary of Results
Systematic Literature Review and Meta-Analysis	Systematic literature reviews (SLR), with or without the corresponding meta-analysis, offer critical assessments and evaluation of the current state of knowledge. By systematically identifying, retrieving, and reviewing all peer-reviewed publications on a specific clinical issue, systematic literature reviews and meta-analyses are essential for identifying gaps in current knowledge and guiding the development of a thoughtful future research agenda.	- IRB Approved Study Protocol - Statistical Analysis Plan - Final Report - Executive Summary of Results - Final List of Included Studies - PDFs of All Included Studies
Secondary Analysis of Controlled Clinical Trials	Health Analytics performs a re-analysis of de-identified, individual participant data from a recently performed controlled clinical trial to gain preliminary insights into important supplemental research questions.	- IRB Approved Study Protocol - Statistical Analysis Plan - Final Report - Executive Summary of Results
Prospective Observational Cohort Study	In this study design, Health Analytics identifies and recruits clinics or clinicians, patients, or caregivers in a prospective study. In collaboration with the client, Health Analytics designs a research questionnaire and examines outcomes (e.g., development of a disease, product satisfaction or quality) specific to your research questions, business objectives and target populations. Using this design, individuals with a certain experience, condition, or receiving a particular treatment, can be surveyed at one time, or followed longitudinally, and compared with another group of individuals unaffected by the condition, not receiving treatment or that had a different experience .	- IRB Approved Study Protocol - Statistical Analysis Plan - Final Report - Executive Summary of Results
Retrospective Cohort Study	In this study design, an eligible population is defined based on historical information and followed forward using previously collected healthcare or administrative data to identify outcomes of interest. A single eligible population with a certain condition can be explored for outcomes of interest, or compared for outcomes of interest, with another group of individuals who are not affected by the condition.	- IRB Approved Study Protocol - Statistical Analysis Plan - Final Report - Executive Summary of Results
Case-Control Study	Case-control studies begin with the outcomes and do not follow people over time. Health Analytics would choose individuals with a particular result (the cases) and interview the groups or examine records to determine what different experiences they had. We would compare the odds of having an experience with the outcome to the odds of having an experience without the outcome.	- IRB Approved Study Protocol - Statistical Analysis Plan - Final Report - Executive Summary of Results