Transcription

Guidelines for protocol writingGeneral information:1-The protocol should be written in “Times new Roman” Font 14, with normalpage layout margins, justified paragraph style and line spacing of 1.15. Titlesshould be written in Bold “Times new Roman” Font 18 and subtitles in Bold“Times new Roman” Font 16.2-Each section of the protocol (Introduction, Aim, Methods, ) should start ina separate page.3-The page numbering of the protocol should be at the bottom center of eachpage.4-Title page should not be numbered.5- The candidate should add the page number of each item in the Ethicsapproval checklist.6- Words in blue are to be replaced by the relevant data.

Faculty of DentistryThe British University in EgyptTitle (The population/problem, intervention, control/comparator, primary outcome , study design & Time factor)Protocol submitted toFaculty of Dentistry, The British University in Egyptfor partial fulfillment of the requirements for the Doctor/ Master Degree in .By(Name, Affiliation and degree/s)Supervised by:(Main Supervisor Name and Affiliation(s))(Assistant Supervisor/s Name and Affiliation(s))Faculty of DentistryThe British University in Egypt(year)

I. Administrative information:1. blem,control/comparator, primary outcome & study design.intervention,2. Protocol Registration: (For clinical trials)Site and registration number of the protocol should be reported before finalapproval of the protocol (e.g. Clinicaltrials.gov: NCT01066572).3. Protocol version:Date and version identifier. (e.g. 25 Jul 2018 Protocol number: 5)4. Funding:A description of the sources of financial and non-financial (material) support.5. Roles and responsibilities:Names, Email addresses, affiliations, contacts and actual roles of candidate and allsupervisors (Coauthors).Roles: e.g. principle investigator, main supervisor, co-supervisorResponsibilities: e.g. initiated the study design, will generate random sequence,will provide statistical expertise in clinical trial design.Name and contact information for trial sponsor.II. Introduction:(should be to the point and concise)6. Background and rationale:Scientific background with all known information related to the point of interest.7.Statement of the problem:The research problem should be clearly identified, stating its prevalence wheneverapplicable.An understanding of how it is original and relevant.How the proposed study will help fill the gap of knowledge in the literature.8.Rationale for conducting the research:Detailed justification for the trial should be clearly stated including why theresearch needs to be conducted in the selected population based on the currentlyavailable evidence.Explanation of potential benefits to patients/ health service, relevance to currentpolicies and community priorities.It is strongly recommended that an up-to-date systematic review of relevantstudies be summarized and cited in the protocol.

9.Explanation for choice of comparators:Selection of control/comparator should be justified with reference including datafrom an up-to-date systematic review.Comparator may be:Placebo, no treatment (Clear reason should be mentioned in case of placebo or notreatment), gold standard, standard of care, another active drug, same drug with adifferent route or dose of administration.10.Hypothesis:A hypothesis states the predicted effect of interventions on trial outcomes.Avoid biased statements, suggesting the author has prejudged the outcome.Stated as a Null or alternative hypothesis.III. Review of literature:Review briefly the existing body of knowledge on the topic (but not in details).Description of the current treatment options and their limitations.Description of the treatment under investigation including; any available dataregarding the effects and mechanism of action of the interventions (published andunpublished) and reference to any previous evidence of its usefulness.Examining benefits and harms for each intervention (summarize the known andpotential risks of the intervention, giving a clear description of any expectedadverse reactions).Outline the rationale for the route of administration, dosage, regimen and periodselected for the proposed study based on available non-clinical and clinical data.Explain how the study will substantially add to science, change practice, savemoney, save lives and/or improve quality of life.This section should be updated and backed up by a brief and focused literaturereview of previous related studies highlighting inadequacies in the body ofevidence.IV. Objectives:Objectives: include aim of the study and hypothesis.Aim of the study reflects the research questions to be answered by the trial.Should be clear & very precise, only a few sentences long.Use neutral words (e.g. “to compare effect of treatment A vs. treatment B onoutcome X”) rather than in terms of a particular direction of effect.Outcome “X” is the primary outcome.

7.PI(E)COTs elementsP: Problem (Population)I: Intervention. E: ExposureC: ComparatorO: Outcome (should be measurable and patient related)T: Time frame. S: SettingIn case of diagnostic test, it will be PIRT (Population, Index test,Reference test and target condition)8.Research question:Research question should be clear, properly formulated and well-structuredfollowed with a question mark at the end (PICO format).V. Methods9.Trial design:Description of trial design, including the type of trial (e.g. parallel group, crossover etc.) and allocation ratio & framework should be included.Framework of a trial is objective to test superiority, non-inferiority, or equivalenceof one intervention with another.The most common design for RCTs is parallel group, two arm, superiority trialwith 1:1 allocation ratio.A- Participants, interventions & outcomes10. Sample size calculationEstimated number of participants needed to achieve study objectives and how itwas determined, including clinical and statistical assumptions supporting anysample size calculations. This should include:1. The primary outcome.2. Values for outcome (mean & SD).3. Statistical test used for calculation.4. Alpha level of significance (5%)5. Power (80%)6. The calculated sample size.7. 20 -30% increase for anticipated missing data depending on nature of study.8. A reference for outcome assumed.Example: To compare clinical and radiographic criteria of deep carious lesions after partialremoval of caries vs stepwise excavation in the form of pulp vitality, independent chi square test

will be done. A total sample size of 102 will be needed (51 in each group), if the true success rateswere 0.69 and 0.91 in SW and PCR respectively based on previous study by Maltz et al., 2012(10),with a power of 80% and 5% significance level. This number have to be increased to 132 tocompensate for losses during follow up by 30%. Sample size was calculated by PS (power andsample size program)(11).11. Study settings:Description of the environment in which a trial will be conducted (e.g, communityclinic, academic hospital) and list of countries where data will be collected.Reference to where list of study sites can be obtained. (Unicentred/ Multicentered)*In case of vitro studies: mention places of;Specimen’s collection, processing and examination. Also devices used inspecimens examination should be specified12. Eligibility criteria (For clinical trials)Eligibility criteria for potential trial participants i.e. Inclusion and exclusioncriteria for participants.They can relate to demographic information; type or severity of the healthcondition; previous or current treatment; diagnostic procedures; pregnancy; orother relevant considerations.In trials of operator-dependent interventions such as surgery, it is usuallyimportant to promote consistency of intervention delivery by also defining theeligibility criteria for care providers and centers where the intervention will beadministered.Try to avoid restrictive participant selection. When trial participants differsubstantially from the overall population to whom the intervention will be applied,the trial results may not reflect the impact in real world practice settings thusaffecting the external validity (generalizability or applicability) Patient informed consent if applicable should be attached (Additionalconsent provisions for collection and use of participant data and biologicalspecimens in ancillary studies, if applicable).13. Recruitment:Strategies for achieving adequate participant enrolment to reach target samplesize.1. Where?2. By whom?3. When?4. How?

5. Expected recruitment rates.6. Duration of recruitment period.7. Financial/non-financial incentives to investigators/participants.B- Assignment of interventions14. Allocation:14a. Randomization:Key elements of Random Sequence Generation in protocol are:1-Method of random sequence generation (computerized random numbergenerator).2- Allocation ratio (1:1, 2:1).3- Type of randomization: simple, blocked, stratified.14b. Allocation concealment mechanism:Mechanism of implementing the allocation sequence (e.g. central telephone;sequentially numbered, opaque, sealed envelopes), describing any steps to concealthe sequence until interventions are assigned.14c. ImplementationWho will generate the allocation sequence, who will enroll participants, and whowill assign participants to interventions?15. Masking/blinding:Who will be blinded after assignment to interventions (e.g., trial participants,investigator/surgeon, outcome assessors, data analysts, statistician ) and how.16. Interventions-Description of Intervention/Control, including how and when it will beadministered, with sufficient detail to allow replication.For drugs, biological agents, or placebos, the protocol description should include: Generic name, manufacturer, constituent components, route ofadministration & dosing schedule. The description of non-drug interventions—such as devices, surgicalprocedures needs additional details about the settings and individualsadministering the interventions. e.g., the level of individuals administeringthese interventions (e.g, for surgeons).

When intervention delivery is subject to variation, it is important to statewhether the same individuals will deliver the trial interventions in all studygroups, or whether different individuals will manage each study group. Interventions that consist of “standard of care” require further elaborationin the protocol, as this care can vary substantially across centers andpatients.In case of RCT;-Strategies used to improve adherence to intervention protocols, and proceduresused to monitor these strategies (e.g. Pill count, adherence reminder sessions).-Relevant care/interventions that will be permitted or prohibited during the trial.-Criteria for discontinuing allocated interventions for a participant, if applicable,e.g. allergic reactions have been observed in rare cases. If this is suspectedwithdraw the trial medication from the patient.17. Outcomes:Primary, secondary and other outcomes should be described, with specific andmeasurable assessment unit.It is important to explain the rationale for the choice of trial outcomes.An ideal outcome is:1. Valid reproducible2. Relevant to the target population.3. Responsive to changes in the health condition being studied.Primary outcome should be: Defined in the PICO. Of greatest therapeutic importance. Essential for decision-making. Used in sample size calculation (mostly) Preferred to be patient oriented or patient-centred or mary outcomeMethodofMeasurementPainVisual analogue scaleC) Data collection, management, and analysis:18. Data collection methodsUnitofMeasurementNumerical

Plans for assessment and collection of outcome, baseline and other trial data,including processes used to promote data quality (e.g. duplicate measurements,calibration of assessors)Description of study instruments used for data collection, along with theirreliability and validity.Describe clearly the data collection process:1. The personnel (standardized training consistency).2. Methods (standardized methods variability).3. Data collection instruments, valid & reliable (questionnaire).4. Data collection forms (appendices/reference).Plans for data collected from participants who discontinue or deviate fromintervention protocols19. Data management:Plans for data entry, coding, security, and storage, including any relatedprocesses to promote data quality (e.g., double data entry). Reference to wheredetails of data management procedures can be found should be included.D) Data monitoring:20. Monitoring (RCT)Formal data monitoring committee21. Harms (RCT)Plans for collecting, assessing, reporting, and managing solicited andspontaneously reported adverse events and other unintended effects of trialinterventions or trial conduct.22. AuditFrequency and procedures for auditing trial conduct, if any, and whether theprocess will be independent from investigators and the sponsor.Ethics and dissemination23. Research ethics approvalPlans for seeking research ethics committee/institutional review board (REC/IRB)approval24. ConfidentialityHow personal information about enrolled participants will be collected, shared,and maintained in order to protect confidentiality before, during, and after the trial.25. Declaration of interest

Financial and other competing interests for principal investigators for the overalltrial and each study site26. Access to dataStatement of who will have access to the final trial dataset.27. Post-trial careProvisions, if any, for post-trial care, and for compensation to those who sufferharm from trial participation28. Dissemination policy-Plans for investigators to communicate trial results to participants, healthcareprofessionals, the public, groups (e.g., via publication), including any publicationrestrictions.-Authorship eligibility guidelines and any intended use of professional writers-Plans, if any, for granting public access to the full protocol & participant dataset.VI. Appendices29. Informed consent (RCT)Model consent form and other related documentation given to participants.30. Biological specimens (Biological specimen)Plans for collection, laboratory evaluation, storage and getting rid of biologicalspecimens for genetic, histopathological, or molecular analysis in the current trialand for future use in ancillary studies, if applicable.31. Checklist for the Ethics approvalAttach the checklist and mention the page number in each part.VII. ReferencesAll references should be written in the same font, and should be written through acitation/reference manager e.g. Mendeley or endnote. All references should followthe same style .

الملخص العربى للبحث (مختصر) صفحة العنوان و المشرفين مقدمة مختصرة اهداف البحث طرق و اساليب البحث

Guidelines for protocol writing General information: 1-The protocol should be written in "Times new Roman" Font 14, with normal page layout margins, justified paragraph style and line spacing of 1.15. Titles should be written in Bold "Times new Roman" Font 18 and subtitles in Bold "Times new Roman" Font 16.