HEALTH SYSTEM
RESEARCH
LEARNING OBJECTIVES:
Definition.
Knowledge, skills of research methods.
Experimental study design.
Pre- and post-marketing surveys.
Application of various statistical procedures in Pharmacy and Medical Research.
The sensitivity and specificity tests in pharmacy practice.
DEFINITION
Health system research is a part of health research. It closely links field evidences
and applies its results for the improvement of the health system.
Initially, it was known as health service research and the terminology shifted to
health system research from 1980s.
The health service research focused on problems encountered in government health
care facilities.
KNOWLEDGE, SKILLS OF
RESEARCH METHODS:
It is important to think about what skills you will develop during your research project when choosing what
and how you will study. it is a large piece of independent work and is therefore something you can really
sell to employers.
Some transferrable skills will apply to any type of research project. These include:
Planning and Organization.
Adaptability and Flexibility.
Problem Solving.
Initiative.
Written Communication.
EXPERIMENTAL STUDY
DESIGN:
Experimental research is a scientific approach to research, where one or more independent
variables are manipulated and applied to one or more dependent variables to measure their
effect on the latter. The effect of the independent variables on the dependent variables is
usually observed and recorded over some time, to aid researchers in drawing a reasonable
conclusion regarding the relationship between these 2 variable types.
Mostly related to a laboratory test procedure, experimental research designs involve
collecting quantitative data and performing statistical analysis on them during research.
Therefore, making it an example of quantitative research method.
PRE- AND POST-
MARKETING SURVEYS:
In the final stages of the drug development, the drug will be exposed on to a group of volunteers and/or patients in
order to obtain the approval required to launch the new drug to the market. Clinical trials are divided into four
phases; being the three first stages the pre-marketing clinical trials and the last one the post-marketing monitoring.
Pre-marketing clinical trials are studies conducted to evaluate, first, the safety and, second, the efficacy of the new
compound in humans.
Post-marketing monitoring includes the identification and monitoring of new additional adverse drug events from
doctors or other health professionals. Unlike previous stages, these will be observational studies where the long-
term effectiveness will be evaluated; these are conducted right after the commercialization of the drug to the “real
world”.
Pre-marketing clinical trials Post-marketing monitoring
Small number of patients: 100- <10000 Big number of patients: >10000
Age and gender limitation No Age and gender limitation
Patients selected with precise diagnosis Patients not selected; more random
Well defined and short duration: 1-3 Undefined and longer duration
years
Careful and constant follow-up Casual and less constant follow-up
Highly detailed reports Much less detailed reports
Other concomitant treatments are Possible concomitant treatments
excluded (usually)
Used of surrogates markers instead of Used the outcome of interest
the outcome of interest
BENEFITS OF THE PRE-
MARKETING CLINICAL
TRIALS:
Controlled environment.
Strict inclusion/exclusion criteria.
Data collected on standardized form.
Follow-up information is generally accessible.
All reports are medically confirmed.
The data collected in clinical trials is clean and reproducible.
BENEFITS OF POST-
MARKETING
MONITORING:
High risk groups.
Long-term effects.
Drug-drug/food interactions.
Increased severity and / or reporting frequency of known reactions.
APPLICATION OF VARIOUS
STATISTICAL PROCEDURES IN
PHARMACY AND MEDICAL
RESEARCH:
Statistics provide methods and tools for making decisions in uncertain or variable conditions, such as those produced from data
collected during research. As study designs increase in complexity, interpreting the results using statistics becomes more difficult.
Planning research involves selecting an appropriate and important research question with measurable outcomes. Next, a single
hypothesis or multiple hypotheses should be developed. These hypotheses will be critical to interpreting the results of the research.
Thirdly, the researcher needs to identify the types of variables being studied, because these will determine the most appropriate
statistical test, method of reporting the data or both. These three steps should be accomplished before commencing the study.
The data must be collected using a good sampling plan; recorded accurately; entered correctly into a computer program (chosen
based on the type of variables studied); and analyzed by appropriate software. However, the most important step is then deciding
based on the computer output. Here, the hypotheses will assist in interpreting the result for the study.
COMMON TERMS
Sensitivity: the ability of a test to correctly identify patients with a disease.
Specificity: the ability of a test to correctly identify people without the disease.
True positive: the person has the disease, and the test is positive.
True negative: the person does not have the disease and the test is negative.
False positive: the person does not have the disease and the test is positive.
False negative: the person has the disease, and the test is negative.
By having a foundational understanding of the interpretation of sensitivity and
specificity, healthcare providers will understand outputs from current and new
diagnostic assessments, aiding in decision-making and ultimately improving
healthcare for patients.
REFERENCES
https://www.formpl.us/blog/experimental-research.
https://generic.wordpress.soton.ac.uk/ethnographicencounters/201
5/07/17/transferableskills/
.
https://howtobecomeapharmacovigilanceexpert.wordpress.com/spe
cific-pv-topics/pre-marketing-clinical-trials-vs-post-marketing-monit
oring/
.
Statistics in Pharmacology.
A basic introduction to statistics.
https://www.statpearls.com/ArticleLibrary/viewarticle/96435.
