Building a Clinical Protocol
- Dr Pallavi Jane Pereira (Unlicensed)
WHAT IS A CLINICAL PROTOCOL?
A Clinical History taking and examination protocol is a document that outlines the methods to conduct a complete clinical case evaluation. The protocol must be carefully designed so that the outcome safeguards the health and interest of the participants/ patients, as well as gathers as much data to fully understand the patient’s condition needed for management of the case by a remote doctor.
A clinical protocol should have:
A full and detailed description of the clinical history (personal info, chief complaints, risk factors, past, family, medical and social history)
Simple, but specific to each case, clinical examinations that can be performed by a trained but not skilled personnel
Evidence-based universal safety precautions and techniques for clinical procedures
All of the above ensures that the final case data would be clear, extensive yet concise and provide enough details for all those involved in the study to use it.
HOW TO BUILD A CLINICAL PROTOCOL?
In order to build a clinical protocol, one has to start thinking about how a doctor would think. For example, when a patient comes in a clinic/ OPD setting, the doctor would first proceed to a checklist that is already in his mind which has molded over years of medical schooling and his or her own experience and skill set. Now, this is a very subjective checklist and may vary between different sets of doctors and also between individual doctors.
Thus to have an objective, robust and medico-legally risk-free system we need to have a clinically correct, personalized, up-to-date and reliable scientific evidence system. Also, for the same reasons, physicians prefer the knowledge base provided by clinical practice guidelines or protocols and recommendations that is compiled systematically by experts in specific areas of medicine. These systems provide an Evidence-Based Approach to Clinical Case Evaluation and are therefore aptly termed as Evidence-Based Medicine (EBM).
HOW TO USE EVIDENCE-BASED RESEARCH TO BUILD A PROTOCOL?
For an evidence-based approach to writing clinical protocols, we need certain guidelines. These guidelines are basically literature in the latest editions of internationally acclaimed medical textbooks (gold standard), research articles in journals (national and international), local disease trends and demographics, etc. While this dogged search for guidelines and answers is not the quickest, it is the cornerstone of good care.
Gold standard medical books include, not in any order, Davidson's Principles and Practice of Medicine, Harrison's Principles of Internal Medicine, Mc Leods Guide to physical examination, Gray’s Anatomy, Robbins and Cotran Pathological Basics of Disease, Guyton and Hall, Textbook of Medical Physiology, etc. You can find a more extensive list here. (ADD LINK)
A review article is a piece of literature that summarizes the current and popular understanding of a topic. A review article also surveys and summarizes previously published studies, rather than reporting new facts or analysis. Medical academic publications that specialize in review articles are known as Medical review journals.
Internationally acclaimed journals include BMJ, NEJM, The Lancet, JAMA, etc.
In research articles, there are different types of studies which denote the quality of the article. For example, Meta-Analysis and Systematic Reviews are the gold-standard of clinical information. They summarise the findings of several studies on a particular subject.
Other ways of gathering Evidence-based medical data:
Online libraries such as PubMed (Central), Scopus, Medline, Cochrane and Google scholar, besides others. These sometimes have a subscription fee for their platform which can be borne by self or by institutions one is a part of.
Online content from internationally prominent and renowned organizations such as WHO, AHRQ, IOM, AMA, IMA, MOHFW, etc. can also be used and is a practice well accepted while researching and citing articles.
Evidence-based research must be backed by peer reviews. Therefore research papers or articles of various subjects always include citation or references. While writing a research paper, it is always important to give credit and cite your sources. This lets you acknowledge others’ ideas and research you’ve used in your own work and to prove your work is based on/ has the backing of certain standard guidelines and to avoid Plagiarism.