Protocol writing

What is your research question ? Why is your study important ? How are you going to do it ? Key Points of Your Proposal

Choosing a topic Should be interesting – to investigator, funding agency, journal editors, consumers (colleagues, public, medical community), etc. Relevance - add new information to the scientific world Simple and manageable in scope (feasibility in terms of money, time, manpower) Expected results likely to alter clinical or health policy decisions in future

The GOOD IDEA must be Feasible Do-able by you Do-able at your institution, hospital & community Acceptable to your institution In conformity with human welfare policies Conceptually significant

Steps in conduct of research planning and execution The first and foremost is formulating a research question, the most challenging part

Identify the Research Question Sources for identifying the research question or problem: Personal experiences Literature review Theories Ideas from others

Identify the Research Question Criteria for evaluating the research question: Significance Practicality Feasibility Interest to researcher

RESEARCH QUESTION IT SHOULD BE A SINGLE SENTENCE IN THE FORM OF A QUESTION. IT SHOULD BE CLEAR, UNAMBIGUOUS AND SPECIFIC

RESEARCH QUESTION IS DRUG “A” BETTER THAN DRUG “B” IN THE MANAGEMENT OF HEPATIC FAILURE IN PATIENTS WITH CIRROSIS? IS ALCOHOLISM RELATED TO THE DEVELOPMENT OF CIRROSIS LIVER?

What to have in a complete study protocol ? Title Summary Background (Literature Review), Preliminary Studies, and Justification/Rationale Study Objectives and/or Questions Testable Hypotheses Study Design Study Population and Methods of Recruitment Variables List and Sample Size

Methods of Data Collection Data Collection Tools Plan of Analysis Timeline Issues for Ethical Review & Approvals Operational Planning and Budgeting Plan of Dissemination/Results Reporting References

Title Title must reflect the central theme: selling point Attractive and easy to understand Concise and Informative: avoid non-informative words like “ A study of---”

Background Briefly sketch the background of the proposal. Critically evaluate the existing knowledge – What is the general situation and how is the problem developing ? – Will it grow rapidly if unchecked? – What has been done so far to address the problem and with what effect? Specifically identify the gaps the proposed research is intended to fill. – What do you propose to do? – Explain why it is a good idea ? State concisely the importance of your research

Significance State concisely and clearly the importance of your study. Emphasize on any novelty or innovation Convey the significance of your research to –1) scientific contribution –2) improving in public health –3) change in health policies –4) change in patient care – etc.,

Study Objectives State the objectives of the proposal: Describe concisely and realistically what the specific research is intended to accomplish Avoid grandiose designs- Over-ambitious proposals that aim to do everything – burdens, determinants, prevention and control of…. Specify clear objectives

Objective -examples To assess the general population knowledge & attitude towards Organ donation. To identify the risk factors for Type-II diabetes. Hypotheses Any hypotheses to be tested. Have clear hypotheses State hypotheses in form of short bulleted list Avoid narrative paragraphs

Hypothesis and Specific Aims List the specific aims one by one concisely Not too many aims; 2-4 best Be specific, no general and ambiguous statements Be realistic, no unachievable aims Aims should be logically linked and arranged accordingly; testing your hypothesis

When you divide a section into subsections, all the pieces should be of the same pie

Hypothesis-example We hypothesize that standard care plus new intervention (additional drug) will be superior to standard care alone in reducing CVD mortality among patients with preexisting heart disease. We hypothesize that prophylaxis with inhaled drug A will be superior to oral preparation of drug B in preventing acute exacerbation of reactive airway disease. We hypothesize that low birth weight is an independent risk factor for type II diabetes.

What is your question Hypothesis Why is your study important  Significance How are you going to do it  Research design Key Points of Your Proposal

Develop the Study Design A study design is the researcher’s overall plan to obtain the answer (s) to the question being asked and the hypothesis being tested It spells out strategies to develop information that is accurate, objective and meaningful It explains methods that will be used to collect and analyze data

Study Design Describe the overall design of the study, example: This is a randomized, double blind placebo controlled trail. This is a cross sectional survey

Research Designs Purpose Study Design To determine frequency & burden of a disease * Cross sectional survey (Prevalence) * Cohort study (Incidence) To identify the risk factors * Cohort study * Case-Control study To determine prognosis of a disease * Cohort study To determine efficacy/ effectiveness of new treatment  * Clinical trials  *Community intervention To evaluate community programs * Evaluation

Feasibility- Study subjects What is the estimated sample size? Who is the study subject (case definition)? Selection criteria (inclusion & exclusion) How they are sampled ? (sampling) Time span for meeting the sample size

Can we meet the sample size? Estimated sample size (based on the research hypothesis, outcome variable) Estimated subjects likely to be available for recruitment Estimated subjects likely to refuse Estimated subjects likely to be lost to follow up

Study Population and Method of Recruitment -- Describe clearly what type of subjects will be studied -- How will they be identified -- Inclusion and Exclusion criteria -- Describe each step involved in recruitment of study subjects -- Describe the role of research personnel in this process -- Mention “informed consent”

Variables List State all the information that is to be collected (demographic data, clinical and lab data) in detail.

Method of data collection Explain precisely when and how the data will be collected, and measured (units). Explain method of ensuring quality control

Data Collection Tools Explain why a particular tool is being used to collect the data. For instance, if a survey questionnaire is being used explain reliability and validity of the instrument. Pretest

Analyzing the Data Upon completion of the study, data should be analyzed List out the appropriate statistical tests based on the type of data

Plan of analysis List the names of variables that will be used in the analyses. State the name of statistical analysis that will be performed to assess the outcome.

References The list of references should be at the end of the proposal. List names of all authors, the title of the publication, the name of journal, year, volume, page numbers.

Benefits of Writing Proposal Allow you to review and critically evaluate the published literature of your interested topic. Develop novel ideas during writing proposal. Convince yourself and others that your research is worth doing. Keep you focused on your research work.

Writing Stages 2. Writing the First Draft 4. Finishing 3. Revising, Revising, Revising 1. Getting in the Mood Save multiple copies of your draft

Conclusions Developing, and communicating a research protocol is a sophisticated and time-consuming process. It is important to understand the steps in developing a research protocol in order to perform an appropriate study and obtain reliable results.

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