Designing Protocol.pdf
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The document outlines the general components and considerations for designing an effective research protocol. It discusses including a title page with key details, a clear introduction defining terms, a justification of need for the study addressing what is known and unknown, a literature review identifying gaps, objectives that are specific and measurable, a methodology outlining the study design and processes, a timeline, and a reference list in a standard format. The protocol provides a written plan to guide execution and evaluation of a research study.
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Protocol writing
DETAILS OF WRITING A PROTOCOL.
By Dr. Amreen Saba Attariya
Dept of Pharmacology
M.R.Medical college, Gulbarga-India
Clinical Trail and Pharmacovigilance
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This document provides an overview of drug utilization studies. It defines drug utilization studies as assessing the marketing, distribution, prescription, and use of drugs in a society with emphasis on resulting medical, social and economic consequences. The goals of such studies are to describe drug use patterns, identify early signals of irrational drug use, enable interventions to improve drug use, and provide quality control of drug use. Data sources include large databases, drug regulatory agencies, supplier data, and practice setting data. Future areas of focus include relating drug utilization data to public health trends, pharmacovigilance, pharmacoeconomics, environmental impacts, and pharmacogenetics.
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Study Objectives and Research Questions: Clearly define the primary and secondary objectives of the study. State the research questions or hypotheses that the study aims to answer. This sets the foundation for the study design and data analysis plan.
Study Design: Describe the study design, such as randomized controlled trial (RCT), observational study, or non-inferiority trial. Specify the study phases (if applicable) and the allocation of study participants to different arms or groups. Justify the chosen design and explain how it aligns with the research objectives.
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M E D I C I N E
M edical research studies can be split into fivephases—planning, performance, documenta-
tion, analysis, and publication (1, 2). Aside from finan-
cial, organizational, logistical and personnel questions,
scientific study design is the most important aspect of
study planning. The significance of study design for
subsequent quality, the relability of the conclusions,
and the ability to publish a study are often underestimated
(1). Long before the volunteers are recruited, the study
design has set the points for fulfilling the study objec-
tives. In contrast to errors in the statistical evaluation,
errors in design cannot be corrected after the study has
been completed. This is why the study design must be
laid down carefully before starting and specified in the
study protocol.
The term "study design" is not used consistently in
the scientific literature. The term is often restricted to
the use of a suitable type of study. However, the term
can also mean the overall plan for all procedures in-
volved in the study. If a study is properly planned, the
factors which distort or bias the result of a test procedure
can be minimized (3, 4). We will use the term in a
comprehensive sense in the present article. This will
deal with the following six aspects of study design:
the question to be answered, the study population, the
type of study, the unit of analysis, the measuring tech-
nique, and the calculation of sample size—, on the
basis of selected articles from the international litera-
ture and our own expertise. This is intended to help
the reader to classify and evaluate the results in publi-
cations. Those who plan to perform their own studies
must occupy themselves intensively with the issue of
study design.
Question to be answered
The question to be answered by the research is of
decisive importance for study planning. The research
worker must be clear about the objectives. He must
think very carefully about the question(s) to be
answered by the study. This question must be opera-
tionalized, meaning that it must be converted into a
measurable and evaluable form. This demands an
adequate design and suitable measurement parameters.
A distinction must be made between the main questions
to be answered and secondary questions. The result of
the study should be that open questions are answered
R E V I E W A RT I C L E
Study Design in Medical Research
Part 2 of a Series on the Evaluation of Scientific Publications
Bernd Röhrig, Jean-Baptist du Prel, Maria Blettner
SUMMARY
Background: The scientific value and informativeness of
a medical study are determined to a major extent by the
study design. Errors in study design cannot be corrected
afterwards. Various aspects of study design are discussed
in this article.
Methods: Six essential considerations in the planning and
evaluation of medical research studies are presented and
discussed in the light.
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- 1. Designing Protocol Dr. Ramesh Bhandari Asst. Professor Department of Pharmacy Practice KLE College of Pharmacy, Belagavi KLE Academy of Higher Education and Research (KAHER)
- 2. DISCLAIMER Views, thought and opinions expressed in this presentation are my own and not necessarily with organization I am affiliated.
- 3. DESIGNING PROTOCOL An official set of procedures for what actions to take in a certain situation.1 A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial.2 A written plan for a study 1 - https://www.dictionary.com/browse/protocol 2 - ICH GCP
- 4. DESIGNING PROTOCOL The protocol is based on the study design: Systematic review/meta analysis RCT/Non-RCT Cohort Case-control Cross-sectional Case Series Case report / Editorial
- 5. DESIGNING PROTOCOL General Components of Protocol: ➢ Title Page / Cover page ➢ Introduction ➢ Need for study ➢ Review of literature ➢ Objective(s) ➢ Methodology ➢ Timeline ➢ References
- 6. DESIGNING PROTOCOL Title Page / Cover Page Title of the study: Population, Intervention/Exposure, Comparator, Outcome (PICO/PECO) Time, Type of study design, settings Names and contact details of Investigator(s)
- 7. DESIGNING PROTOCOL Introduction ➢ Definition of technical terms ➢ Acronyms written in full (first use) ➢ Introduce the topic of the research ➢ Enough detail to understand the research
- 8. DESIGNING PROTOCOL ASSESSMENT OF COGNITION LEVEL AMONG EPILEPSY PATIENT’S AND IT’S PREDICTORS: A CROSS SECTIONAL STUDY ➢ Definition of terms (Epilepsy, cognition level, Predictors) ➢ Introduce research topic ➢ Place those terms in context with the research topic (assessment of cognition level)
- 9. DESIGNING PROTOCOL Need for Study ➢ What is already known about this topic? ➢ Define the research problem. ➢ Research question outline clearly ➢ Research question justified given what is already known about the topic?
- 10. DESIGNING PROTOCOL Need for Study ➢ Explain why the current research is essential. ➢ Logical progression from existing to current knowledge progression ➢ What values does the paper add? ➢ Are the claims justified?
- 12. DESIGNING PROTOCOL Review of literature ➢ Process of: ✓ Synthesizing what is known and what is not known ✓ Identifying the gap
- 13. DESIGNING PROTOCOL Objective(s) ➢ Purpose of the study ➢ Clearly state the objective(s) ✓ S – Specific ✓ M – Measurable ✓ A – Achievable ✓ R – Relevance ✓ T – Time-bound
- 14. DESIGNING PROTOCOL Objective(s) ➢ To compare the cognition level among epileptic patients taking anti-epileptic drugs using three different scales. ➢ To identify the predictors affecting cognition level. ➢ To correlate between the cognition level and duration of anti- epileptic drugs
- 15. DESIGNING PROTOCOL Methodology ➢ Study design: Validity and Reliability ➢ Study Site ➢ Sampling methods ➢ Sample Size ➢ Study population
- 16. DESIGNING PROTOCOL Methodology ➢ Subject Selection: ▪ How? ▪ What Population do they represent? ▪ Generalization? ▪ Process ➢ Materials required
- 17. DESIGNING PROTOCOL Methodology ➢ Description of Interventions/Exposure ➢ Data collection ➢ Analysis Plan ➢ Variables defined ➢ Proposed Outcome
- 18. DESIGNING PROTOCOL Timeline Mention the timeline for the completion of the study. Starts from Development of Protocol to the completion of thesis writing.
- 19. DESIGNING PROTOCOL References ➢ Vancouver system ➢ Chicago style ➢ MLA (Modern Languages Association) system ➢ The APA (American Psychological Association) system ➢ The Harvard system ➢ The MHRA (Modern Humanities Research Association) system
- 20. DESIGNING PROTOCOL Vancouver style references ➢ Journal: Manford M. Assessment and Investigation of Possible Epileptic Seizures. Journal of Neurology, Neurosurgery & Psychiatry. 2001;70:ii3-ii8.
- 21. DESIGNING PROTOCOL Vancouver style references ➢ Book: Frog RR. Experts guide to artisanal fly cuisine. 2nd Ed. Halifax: Imaginary Publishing INC; 1998. 243
- 22. DESIGNING PROTOCOL Vancouver style references ➢ Internet/websites: Wikipedia.org. Introduction to general relativity [Internet]. 2021 [updated 2021 May 28; cited 2021 July 13]. [9 screens]. Available from: https://en.wikipedia.org/wiki/Introduction_to_gen eral_relativity.