Components of a good Protocol

Components of a good Protocol

This discussion describes sections which would be expected to be found in a good protocol, in the order given.

The sections and their arrangement might, however, vary with the topic selected:

a. Title: A good title says what will be done, and where it will take place. It is usually best to polishthe title

when you have finished a report as your ideas will inevitably shift as your study proceeds. A typical title would be

Risk factors for teenage smoking in the Blacktown community.Make sure the title reflects what the intended study will actually cover and avoid giving a vague, rhetorical or

romantic title. Do not give a double title (eg: Smoking in the Blacktown community, or why kids die young, as

is popular in magazine articles). You will probably need to rewrite the title as the study progresses. This is a healthy

sign, however, as it shows you have reshaped your basic idea as you develop the study design.

b. Table of contents: This should assist the reader to find the main sections of the Protocol, but should not

be detailed down to the level of sub-sections. Lists of tables or figures, and a glossary is not essential.

c. Introduction: This should introduce the importance of the disease or health state and give reasons for the

risk factors or behaviour modifiers selected for study, supported with ample references (use this opportunity to draw

on the journal reviews for referencing purposes). The introduction should at least have:

Motivation for the study (e.g. local relevance of the health state, severity or extent of disease, new method

or technique). Personal motivations are not relevant (eg: I, myself, have asthma).

Study objectives (what the study aims to achieve). Potential products (e.g. reports, journal publications)

can be outlined.

Ethical constraints, briefly described where necessary, and relating to the need to deal with humans in a

respectful and empathetic way when collecting data.

d. Journal reviews: The importance of this section has already been discussed. Make sure you study three journalarticles in depth and provide review of each. Each review should include a summary, assessment, and statement

of relevance to your own study. The assessment component should discuss any weaknesses or problems detected in

the paper (does each paper address all six interrogative questions, who, what, where, when, why, and how? Would

a few diagrams have helped? Does it seem logical and easy to understand?). It would be pedantic to use who,

what, where, etc. as sub-headings so try to blend these areas into a cohesive answer. Include the journal abstracts of

the papers used in an appendix of your Protocol to assist the marker. Entire copies of the paper are not necessary.

e. Study design: This is probably the most neglected part of any protocol, but it is very important. It gives,

in concise language, an overview of the epidemiological design and how the study will be done. You can also mention why you have chosen the particular design.

f. Materials and methods: Under this section place of study, population at risk, the sampling frame, and the

sample and sampling technique to be included.

In epidemiological studies, materials includes data, and the measuring instrument (eg: questionnaire) used to obtain

the data. You need to discuss which instruments you will use for data collection. The section should refer to your

questionnaire which should be presented in its entirety in another appendix at the end of the report, as it will be

assessed. You could also include the first version of your questionnaire (before pilot testing), and comment on why

some questions were modified. You might also want to add information motivating why each question was included.

Criteria for interpreting the answers to each question to guide the interviewer in the field should be given as the

criteria contribute substantially to the standardisationof the questionnaire (ie.: the process by which it could be

applied to the same population group by different interviewers at different times, and still yield the same results).

Questionnaire design is challenging, but this area will be well covered in lectures, with practical examples of good

and bad questions and approaches.

The questionnaire presented in the Protocol should essentially be usable, although there is not an expectation that it

will have the same artistic and layout quality as a final questionnaire. Please note that students are not required to

go out and do an actual survey using the questionnaire; in fact this would be in contradiction with University Ethics

Committee requirements.The intended analytical methods which would be used to analyse the data should be discussed down to details of

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the statistical tests and computer applications which would be used. It should be noted that a grey boundary exists

between design and method but, in general, design is more concerned with the overall plan, whereas method tends

to cover detail explaining how the survey would be carried out (locations where interviewers would stand, how a random sample would be drawn, etc.).This section is the heart of any protocol and will be discussed in detail in the class.

g. Presentation: In the Protocol you should mention how you would want to show your results, if the study

was carried out. Results can be shown in different ways, although tables and different types of graphs are the main

methods. In this regard one of the Subject Exercises will deal with the use and conventions (rules) for setting out

tables, graphs, maps, etc..

h. Products: This would include a discussion of the number of papers or presentations which might arise from the

study, what their titles might be, and which journals or venues (such as conferences) you might target for presenting

your results. Any other presentation opportunities and possible reports should also be mentioned.

i. Required resources: The Protocol should include a timeline for carrying out the survey, analysis and report,

preferably in Gantt Chart format. A well-constructed basic budget in spreadsheet format is also required showing

details of income and expenditure on capital items, expendables, maintenance and salaries. It is not necessary to

prepare this using Excel, however. Where Excel or other spreadsheets are used, they must be copied back into

the one Word document used for submission in the Protocol.

j. Referencing: This is a very important section as in scientific reporting all statements of fact must be supported by research published in refereed (peer-reviewed) publications such as professional and scientific journals, or

by the reporters own research