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Division of Population Health Sciences

Irish Gerontological Society PhD Study Day 2013

Royal College of Surgeons in Ireland Coláiste Ríoga na Máinleá in Éirinn

Protocol development

Dr. Rose Galvin Royal College of Surgeons in Ireland



The protocol

Getting a PhD An action plan to help manage your research, your supervisor and your project

John A. Finn

Routledge Study Guides



Questions to consider...

• Why write a protocol?

• What are the components of a protocol?

• What do I need to consider if I am writing a protocol for a grant?



Why write a study protocol?

• Forces researcher to create, define, and refine the research project – Check if the objectives can be achieved

– Check the feasibility of the study

– Prevents failure to collect essential information

– Lays down the rules for all involved

– Required for ethical approval

– Grant applications

– Writing articles



How to write a protocol – basic structure

• Checklist of items to include

1. Title 2. Background 3. Research question – aims & objectives 4. Methods 5. Ethical considerations 6. Project management 7. Timetable 8. Resources 9. References



1. Title

• Ensure title does not promise more than the thesis (or the paper) can deliver – ‘The effect of....on.....’

– ‘ The association between ....and.....’

• Ensure title is succint and avoids redundant phrases

– ‘ A study of...’ – ‘An exploration of…’

• Academic journals

– Running head



2. Background

• Builds case for the proposed study

– Present burden of the problem in quantitative terms – Puts the study in context

– Demonstrate why this research is important

• Suggestion – Write a ‘significance’ paragraph at the end of the background section

– This will help to frame the current status of the work in the field and your study’s potential contribution



3. Research question: aims & objectives

• State overall aim • Objectives link to the hypothesis to be tested

– (primary/ secondary objectives)

• Hypothesis

– Null hypothesis – Alternative hypothesis

• Research question

– PICO/PRO/PER may help to clarify research question



Recap on basic structure of protocol





4. Methods

• Study design and setting – What study design will be

used

(Cohort, case-control, cross-sectional, RCT, qualitative)

– What are the strengths and weakness of the particular design?



Standardised reporting of biomedical research

• Guidelines to guide standardised reporting – available for all study designs

• Uniform reporting of different elements of the study – Background

– Methodology

– Statistical approach

– Results

– Discussion

– Funding sources

• Requirement for publication by all major academic journals



Standardised reporting guidelines

• Follow appropriate guidelines http://www.equator-network.org/home/

• Protocols for RCTS: SPIRIT (only published in January 2013)

• RCT: CONSORT

• Observational studies: STROBE

• Diagnostic accuracy: STARD

• Systematic reviews: PRISMA

• Qualitative research (focus groups and interviews): COREQ

http://www.equator-network.org/home/





4. Methods

• Study sample – Inclusion criteria

• Describe and justify study sample

• Address any potential biases – invalidate study results?

– Exclusion criteria

• Justify reasons for exclusion e.g. feasibility or safety

• Address any potential biases – invalidate study results or applicability to more general samples

– Consider availability of study sample



4. Methods

• Data required – Explanatory variables

• Potential risk factors, protective factors, confounders

– Outcome variables

• Dichotomous (dead/alive, yes/no), continuous (time, blood loss), ordinal (Likert scale)

Example

• Smoking: definition, quantification, categories

• Osteoarthritis: case definition, definition of a control

http://www.annals.org/content/vol142/issue4/images/large/9TT5.jpeg



4. Methods

• Data collection – How?

• Interview, observation, record review, clinical assessment

– By whom? • Interviewers, clinician (training effect)

– Tools? • Questionnaires – self or interviewer administered – face to face or

telephone interview

– Blinding? • Blinding of outcome assessor, patient



4. Methods

• Data analysis/ sample size calculation – Describes all data analysis issues

• Data management procedures

• Analytic approach

• Sample size/power calculations

• Interview, observation, record review

– Common critique • Insufficient description of analytic approach

• Inadequate control for confounders

• Insufficient description of the handling of missing data

• Not enough consideration of attrition



Structure of protocol





5. Ethical Considerations

• Informed consent

• Confidentiality, anonymity

• Data storage and protection

• Ethical review committee



Structure of protocol





6. Project management

• Participating institutes and persons

• Responsibilities of each partner

• Quality assurance – Compliance with protocol

– Problem identification

• Data ownership



7. Timetable

• Study plan – Study design, tools, ethical approval, recruitment, purchases

• Pilot study – Testing of methods and questionnaires – Adjust procedures as result of pilot – Opportunities and threats may change

• Final study – Data collection – Analysis – Write up



Timeline for study



8. Resources

• Extent of this section varies depending on target audience

• Specify – Available resources – Requested resources

• Keep budget – Reasonable – Detailed – Well justified



9. References

• Limit number of references to key articles

• Follow recommended referencing style – Vancouver style

– Harvard style

• Use of bibliographic/reference management systems – Endnote

– RefWorks



General issues

• Poor layout – Editing/typographical/grammatical errors

– Inconsistencies

– Omitted tables or graphs

• Use of jargon, abbreviations, or undefined terms

• Information appearing in wrong sections

• Limitations not adequately discussed



Protocol writing for grant bodies

• Know your funding source – Seek clarity from grants administrator

• Review successful grant applications from funding source

• Allow time – Preparation – Revision

• Be prepared – Costs – Collaborators



Summary

• Protocol follows a basic structure – 9 key areas

• Forces researcher to refine research project – Feasibility etc.

• Protocol guidelines vary depending on study design – CONSORT: RCT

– STROBE: Observational studies

– PRISMA: Systematic reviews & meta-analyses



Remember……

The crucial examination of your PhD candidacy is that of the thesis, not the viva.

• “40% of examiners . . . said that the decision about the thesis

was made before the viva. In 74% of cases the viva served merely to confirm the examiners’ opinions of the candidate. . .”

(Jackson and Tinkler 2001: 361)

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