RESEARCH PROTOCLE
- Definition
- Outline of a research protocol
- Research plan
- Conclusion
- References
Definition
Written document describing the study, whatever the type of clinical research, with or without experimentation. It is a detailed description of all the steps which allows to avoid any ambiguity of interpretation and any subsequent improvisation.
It is developed jointly by: project initiator, promoter, investigators (clinicians, epidemiologists, scientists, etc.), methodologist (guarantor of scientific value) as well as the various people involved in the project: (biologists, computer scientists, psychologists, pharmacologists, etc.
- Outline of a research protocol
The standard plan, valid for all research, includes:
1. Title page;
2. Synoptic summary;
3. Introduction: justification, context, objectives;
4. Materials and methods: type of study, population studied, practical procedure, statistical aspect, regulatory and ethical aspects;
5. Bibliography;
6. Annexes.
II.1. Project title page
The information on the title page is:
• Title of the study (clear, precise, short but explicit);
• Name of the principal investigator and contact details;
• Names of the principal co-investigators and their contact details ;
• Name of the promoter and his address;
II.2. SUMMARY
In the abstract, it is necessary to specify the objectives, methods, expected results, and keywords of the planned study. It includes:
- Title of the study;
- Introduction = justification of the study;
- Methodology:
• Type of study and objectives
• Population characteristics (selection criteria)
• Evaluation criteria
• Experimental plan and number of subjects
• Study procedure and expected duration
• Analysis strategy
- Possible results and/or benefits expected
II.3. INTRODUCTION
In the introduction, the following sections should be elaborated:
General context : its aim is to attract the attention and interest of the reader/evaluator from the outset. To situate the project in relation to the current state of knowledge and practices (bibliography) and possibly specify the importance of the question addressed in scientific, public health and economic terms.
Problematic : This is the conceptualization of the research problem. It consists of defining the problem, identifying and defining the main aspect(s) involved in the study by highlighting the importance of the subject for example:
- Problem not solved by previous work;
- Providing useful information in the field;
- Expected outcomes of the research;
- Perspectives for the scientific community, for public health, for the environment, for the clinic, etc.
Identification of the research question
In which the questioning felt by the researcher, justifying the project presented, must be specified and the situation with regard to this questioning (literature review) must be explained.
To clearly formulate a clinical question, it is necessary to:
• First classify it according to the type of question (diagnosis, therapeutic, etiology, prognosis, educational).
• Then break it down into 4 PICO criteria: Patient, Intervention, Comparator, Outcome, result (judgment criterion).
- P atient or Medical Problem: *Who is the intervention for, the method to be applied? Men, women, of a certain age group, having such a characteristic, such a pathology?
*And/or the problem it poses (diagnosis….)
- Intervention : Are we looking for information on an exposure, a drug treatment, a physical treatment, a diagnostic test, a health education action?
- C omparison: what should the intervention described above possibly be compared to? Reference method, alternative? example: placebo, reference treatment or test, controls, etc.
- Outcome : in English (clinical outcome, measured event, judgment criterion, practice sought? example: one-year mortality rate, myocardial infarction rate, etc.).
Having answered these 4 questions, you are able to search for your keywords (NB: the question regarding comparison does not apply in every case).
Example: Is there any benefit ( O ) in vaccinating preschool children ( P ) against chickenpox ( I ) rather than allowing epidemics to develop spontaneously in schools ( C )?
In Table 2, some research questions are formulated according to the medical problem.
Table 1Example of research questions according to the problem
| Medical problem | Question |
| Diagnosis: | How to select and interpret a diagnostic test? |
| Etiology: | How to identify the causes of a disease? |
| Treatment: | How to choose the best treatment for the patient? |
| Prognosis: | How to anticipate the evolution and probable complications of an illness? |
| Patient education: | How to provide patients and their families with the information they need |
Research objectives
The project objectives are the keystone of the protocol. Indeed, the choice of objectives , in particular the specific objectives, must be in perfect harmony with the questions previously raised, as well as the means envisaged.
General objective: this is the aim or interest of the study. The general objective must express what is the expected benefit of the answers provided by the research.
Example: “Evaluation of excess mortality from myocardial infarctions in order to reduce it”.
Specific objectives
The specific objectives must express, in technical terms, the areas precisely studied.
Example: “Study the risk factors for infections associated with care in the intensive care unit.”
Assumption
The formulation of a hypothesis characterizes analytical studies (as opposed to descriptive studies). It must be perfectly explicit and unambiguous and expressed in an affirmative mode.
Example: “We hypothesize that treatment A is …… “
All terms used in the “hypothesis sentence” must be defined and transformed into operational variables (limits, possible classes, etc.) for the purposes of statistical calculations.
The argument supporting this hypothesis must be recalled, whether it comes from the literature, the team’s experience or the researcher’s intuition.
II.4. Materials (patients) and methods
Includes the following:
-Research device (type of study);
-Participants (population): sampling and recruitment procedures ; study population; Sampling: inclusion criteria, exclusion criteria, recruitment methods or procedure, sample size;
-Data collection procedures/Study conduct;
-Variables and measuring instruments;
-Statistical analyses.
1. Type of study
Name and describe the chosen research device. The main devices: experimental, quasi- and pre-experimental, single case, observational (case-control, cohort, transversal).
The choice must be made considering: nature of the problem, available resources, internal and external validity of the devices.
Discuss potential biases that may threaten the validity of the study and indicate how they will be minimized.
Discussion of the validity of the project
External validity
This discussion is intended to clarify the use that can be made of the research results. The reproducibility of the results will be a function of the limitations related to:
* to the study population: Example: selection linked to hospital recruitment,
* to the conditions of the study: Example: experimental nature of the test.
Internal validity
This discussion, which is essential in analytical studies, must address, one by one, the 3 major biases likely to affect the quality of the results: * selection bias (the groups compared differ systematically, before the start of the experiment for any characteristic), linked to the characteristics of the groups;
* observation bias (the observation of the compared groups differs systematically for any aspect of the exploration method), linked to the observation conditions;
* confusion bias (there is a “confounding” factor likely to artificially create a cause and effect relationship between 2 other factors), linked to a factor external to the groups and to the observation (outside temperature and neuroleptic accident).
2. Study population
A. Characteristics
Specify the target population: the population on which the research focuses. This does not always involve individuals. Units of analysis.
This step of the protocol must specify:
*Inclusion : precise description of the characteristics of the subjects (age, sex, duration, etc.), of the pathology envisaged (the clinical and paraclinical definition of the disease studied) and written consent of the subject.
*Exclusion: exhaustive list of criteria/characteristics prohibiting participation in the study (reason for caution, difficulty of evaluation or monitoring, ethical or legal problems)
*Relative exclusions
– To illness,
– To the sick,
– To incompatible treatments.
*Exit criteria
The outputs of the trial should be explicitly defined and recorded in order to enrich the discussion of the results.
B. Number of subjects required
It is necessary to insist on the need to grant the study the means (number of subjects required) of its ambitions (that is to say its objectives and its hypotheses).
The statistician who will process the data must be involved in the development of the protocol from this stage. Demonstrate the parameters used, power, justify…
*Sampling
Consists of constituting a subset of the target population which is as representative as possible,
The characteristics of the sampling (possibly the design and type of survey) allow the reader to assess the representativeness of the sample studied (and therefore, the external validity).
The main sampling methods: probability and non-probability. The choice depends on the research question, the budget, the availability of lists of individuals.
*Drawing
Specify its technical modalities, the possibilities of decoding in the event of an emergency and the identification of those responsible (particular difficulties during multicenter trials).
C. Action to be taken in the event of:
Lost from sight, failure to follow protocol.
3. Data collection method (observation strategies)
Justify the method. Who will collect them? Training of assessors? Order of tests? Where? When? Time required for each subject? Blinded measurements? Justify all choices.
If verification of an intervention: who will perform the intervention? Where will it be performed? Dosage (time and duration)? What to do to avoid abandonments?
Control group? What are they offered? Always anticipate difficulties…
Variables and measuring instruments
The data to be collected should be limited to the framework of the specific objectives and the variables included in the hypotheses. Must be measurable and observable; They must be defined operationally; it is often convenient to describe the variable and its measuring instrument at the same time (summarily describe the measurement procedure, the rating scale and report its metrological qualities);
-Can be categorized into dependent, independent or other variables (controls, confounders, intermediates); Take into account feasibility and required quality (precision).
Pre-testing is sometimes necessary;
Attach the instruments in the appendix (protocol, data collection sheet).
Data source
These may be direct sources (environmental sources) (clinical examination data, interview data, etc.) or indirect sources (archives, statistical data already collected, etc.).
What to do in the event of:
* Failure to comply with protocol
These difficulties are essential to consider in studies characterized by the continuous monitoring of a population (survival study, etc.).
* Lost from sight
Provide for recording of test exit conditions.
Specify the characteristics of non-responses and those lost to follow-up (aspect, qualitative).
Data quality
Specify the steps and means of control intended to prevent unequal quality between groups or a drift in the quality of the collection over time. With regard to clinical trials, specify adherence to the principles of “Good Clinical Practice”. The guarantees of “Good Practice” (calibration, verification of equipment) of biological analysis laboratories will be specified.
5. Data analysis
Describe and explain the main statistical operations for analyzing data;
Provide the plan and stages of the analysis. This is guided by the meaning of the question asked;
A first stage, descriptive, will guide the use of certain analytical techniques;
The statistical methods used must be justified.
6. Ethical considerations
Consists of taking all necessary measures to respect the integrity of the participants.
The research ethics committee: may require, recommend or suggest changes to the protocol
Consent Form : Contains four main elements:
– Describe the role of the subject;
– Insist on free and informed consent and the right to withdraw;
– Discuss the benefits and risks of the research;
– Insist on respecting the confidentiality of the results.
Patient information and informed consent letters should be included in the appendix.
III. RESEARCH PLAN
1. Calendar
* Specify the research steps including preliminary studies and analysis.
* Set dates for interim and final reports.
2. Stopping rules
They concern studies involving a danger or a significant issue. They must be clearly stated.
3. Resources required
It is necessary to insist on the need for a real budget, specifying the total costs (in personnel, equipment, operating costs, etc.) generated by the research.
- Funding
Every researcher must know that there is no research without cost! Mobilization of resources
financial is a mandatory condition for the successful completion of the research operation. Thus, any researcher
must be able to develop, defend and mobilize a study budget before committing to the field.
It is useful to specify the planned expenditure for each stage of the programme, which allows financiers to stagger their support “effort”.
- Other resources
Existing resources, their financial value and origin must be identified; Personnel, Premises, Equipment.
4. Final report
The target audience (type of journals) for the results should be mentioned because this determines the presentation of the final report and its promotion. The signatories of the reports should be provided for as far as possible.
III.5 References and annexes
Include all references uniformly
Annexes
Useful to supplement the information given in the protocol. No information essential to the project Measuring instruments, data collection sheets, description of the intervention program to be evaluated, letters of support, consent form, acceptance of the ethics committee
Conclusion :
The research protocol is a research project precisely written by a researcher. This project includes the clauses that require the researcher to conduct the research work according to the chosen method. The research protocol facilitates the research work and guarantees the validity of the results.
The study method which constitutes the essential part of the research protocol must be reproducible allowing other researchers to repeat the experiment and thus verify the veracity of the results of a published study.
Thus, every researcher must master the procedure for developing a research protocol which is a guarantee of credibility of the scientific articles that he will have to publish throughout his career. All research must result in publication. In its absence, research on humans is not ethical.
References
-Contandriopoulos. AP et al. Knowing how to prepare research, define it, structure it, finance it. Editor Gaëtan Morin, Montreal, 2005
-Alla F, Bouaziz V, Ducki C et al. Standard plan of a clinical research protocol.INSERM, 2004 http://www.chu-nancy.fr
-Jean-Denis. C, Michelle. F, “Methods of written and oral communication” 3rd edition; Dunod, Paris, 2008, 205 p.
– Patrick Reid. C. P, “Manual for the preparation and writing of research proposals” French version C. Doumenge (Ed.) Vienna, Austria, IUFRO special programme for developing countries, 2001, 158 p.
– the-research-question-pico-method. Available at http://www.mgtfe.be/guide-de-redaction/5-recherche-bibliographique/5-3-la-question-de-recherche-methode-pico/
-formulation of the clinical question, the PICO methodology file:///C:/Users/USER/Downloads/BURTIN2_CIFEPK_03-02-12.pdf