Session 3: Protocol and MSSM project

Question 1

Define a protocol.

Answer 1

A formal written document which is prepared prior to the study. It documents the background to and reasons for the study; states the aims and objectives; provides the details of the methods that will be used; and outlines the ethical aspects as well as important administrative aspects of the study.

Question 2

Describe the 8 functions of a protocol.

Answer 2

1. Helps researcher focus on main issue
2. Enables outsiders to understand what is planned
3. Necessary if funding is sought from funding agencies
4. Needs to be submitted to a research ethics committee before the research can be started
5. Required to request permission to get access to the facility
6. Needed to confirm the registration of a student for postgrad study
   7.

Question 3

Describe the 8 functions of a protocol.

Answer 3

1. Helps researcher focus on main issue
2. Enables outsiders to understand what is planned
3. Necessary if funding is sought from funding agencies
4. Needs to be submitted to a research ethics committee before the research can be started
5. Required to request permission to get access to the facility
6. Needed to confirm the registration of a student for postgrad study
7. Helps in the writing up of the study as methods and motivation are described
8. Enables other researchers to repeat the same design in another setting and allows comparability of results

Question 4

Describe and discuss the 10 different components of a protocol.

Answer 4

1. Title and author’s page
   - an informative title which clearly describes the purpose of the study
   - principal investigator’s name, qualifications, institutional affiliation and a list of co-investigators should be stated.
2. Introduction
   - describes the problem to be studied and reviews relevant available information
   - motivation of the research
   - overall aim should be stated
3. Methods
   - includes term definitions, state the study design, identify the study population and sampling frame source
   - state the measurement method and the intention to conduct a pilot study
4. Logistics and time schedule
   - clear task allocation, attaching a realistic time schedule for carrying out various aspects of the study
5. Data management and analysis
   - details such as data entry, cleaning and data security
   - methods of analysis, any statistical support received
   to date or planned future
   - mock tables
6. Resources:
   - indicate available personnel, equipment and funds
   - an estimated budget
7. Ethical and legal considerations
   - plans for safeguarding the rights and welfare of the
   participants
   - steps to ensure legal and ethical access to
   communities
   - method of obtaining informed consent, anonymity and
   confidentiality of data
8. Reporting of the results
   - state specific format in which results will be reported
   to scientific community
   - give feedback to stakeholders directly
   - avoid specialised terminology
9. References
   - include references using an accepted format and only list sources in protocol
10. Appendices
    - include a copy of the questionnaire, consent form,
    permission letter

Question 5

Define bias in research.

Answer 5

Any approach or process which produces results or conclusions that differ from the truth in a systematic (one-sided) way.

Question 6

State the 7 stages at which bias can enter the research process.

Answer 6

1. Reviewing the literature- articles restricted to those that support a particular view
2. Sample selection- selecting a sample which isn’t representative or selection of non-comparable groups
3. Executing an intervention - patients unintentionally being influenced by the intervention, thereby contaminating the results
4. Measuring exposures and outcomes - asking leading questions, using instruments that over- or underscore measurements, hiding real differences or showing differences where here are none
5. Data analysis - deciding which categories variables fit into after instead of before the results
6. Interpreting the data - over-interpreting results that are statistically significant but not of clinical relevance
7. Publication of results - publishing only positive results gives a false impression on state of knowledge about the subject