How to design a protocol for medical research

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How to design a protocol for medical research

  1. 1. How to Design a ProtocolHow to Design a Protocolfor Medical Researchfor Medical Research(research proposal),(research proposal),Abbassia Psychiatry Hospital, training sectionAbbassia Psychiatry Hospital, training sectionDr. Ahmed ALbehairy, M.DDr. Ahmed ALbehairy, M.DConsultant of Psychiatry, MOH, EgyptConsultant of Psychiatry, MOH, Egypt
  2. 2. Abbassia Psychiatry Hospital, training sectionAbbassia Psychiatry Hospital, training section In need for training a group of working staffIn need for training a group of working staff( psychiatrists and psychologists ) , in research( psychiatrists and psychologists ) , in researchmethodology .methodology . Aims to participate and share with others, interestedAims to participate and share with others, interestedorganizations, in forming a data base of psychiatry inorganizations, in forming a data base of psychiatry inEgypt .Egypt . Also , aims to improve patients’ care through moreAlso , aims to improve patients’ care through moreunderstanding of research and to get a critical thinkersunderstanding of research and to get a critical thinkerspersonnel , do study design and do statistics.personnel , do study design and do statistics.
  3. 3. Abbassia Psychiatry Hospital, training sectionAbbassia Psychiatry Hospital, training section Approaching our aims , a work shop in medicalApproaching our aims , a work shop in medicalresearch has been held, in Abbassia psychiatryresearch has been held, in Abbassia psychiatryhospital, on 28 –29- 30 may 2013.hospital, on 28 –29- 30 may 2013. 21 personnel of our staff attended the21 personnel of our staff attended theworkshop.workshop.
  4. 4. Abbassia Psychiatry Hospital, training sectionAbbassia Psychiatry Hospital, training section Continuing to prepare the emerging research team in abbassia , 3Continuing to prepare the emerging research team in abbassia , 3training projects have been allocated as follow:training projects have been allocated as follow:‫اللول‬ ‫المشرلوع‬‫اللول‬ ‫المشرلوع‬::“Burden on Families of Adolescents diagnosed with Psychiatric Disorders”“Burden on Families of Adolescents diagnosed with Psychiatric Disorders”Cross sectional studyCross sectional studySCID-ISCID-ISample Size= 120Sample Size= 120Adolescence Clinic- Abbasseya Hospital for Mental HealthAdolescence Clinic- Abbasseya Hospital for Mental Health:‫العمل‬ ‫فريق‬:‫العمل‬ ‫فريق‬11--(‫البحث‬ ‫)منسق‬ ‫حسن‬ ‫محمود‬ ‫حسن‬(‫البحث‬ ‫)منسق‬ ‫حسن‬ ‫محمود‬ ‫حسن‬22--‫الوهاب‬ ‫عبد‬ ‫اسماء‬‫الوهاب‬ ‫عبد‬ ‫اسماء‬33--‫فرج‬ ‫اكرم‬‫فرج‬ ‫اكرم‬44--‫حماد‬ ‫عبدالرحمن‬‫حماد‬ ‫عبدالرحمن‬55--‫عبدالحميد‬ ‫صل ح‬ ‫محمد‬‫عبدالحميد‬ ‫صل ح‬ ‫محمد‬66--‫لطفى‬ ‫عبدالعزيز‬ ‫رنا‬‫لطفى‬ ‫عبدالعزيز‬ ‫رنا‬77--(‫نفسى‬ ‫)اخصائى‬ ‫عبدالخالق‬ ‫احمد‬ ‫عبير‬(‫نفسى‬ ‫)اخصائى‬ ‫عبدالخالق‬ ‫احمد‬ ‫عبير‬‫على‬ ‫السميع‬ ‫عبد‬ ‫ريهام‬ /‫د‬ :‫العام‬ ‫المشرف‬‫على‬ ‫السميع‬ ‫عبد‬ ‫ريهام‬ /‫د‬ :‫العام‬ ‫المشرف‬
  5. 5. Abbassia Psychiatry Hospital, training sectionAbbassia Psychiatry Hospital, training section‫الثانى‬ ‫المشروع‬‫الثانى‬ ‫المشروع‬::“Effectiveness of Parent Training Program for Adolescents diagnosed with“Effectiveness of Parent Training Program for Adolescents diagnosed withConduct Disorders”Conduct Disorders”Cohort Prospective studyCohort Prospective studyTools: revised Behavior Problem ChecklistTools: revised Behavior Problem Checklist& Parenting Style Questionnaire& Parenting Style QuestionnairePopulation: candidates with conduct disorder from 1/6/2013 to 31/12/2013Population: candidates with conduct disorder from 1/6/2013 to 31/12/2013Adolescence Clinic - Abbasseya Hospital for Mental HealthAdolescence Clinic - Abbasseya Hospital for Mental Health:‫العمل‬ ‫فريق‬:‫العمل‬ ‫فريق‬11--(‫البحث‬ ‫)منسق‬ ‫عراقى‬ ‫صفاء‬(‫البحث‬ ‫)منسق‬ ‫عراقى‬ ‫صفاء‬22--‫شاهين‬ ‫احمد‬ ‫حسناء‬‫شاهين‬ ‫احمد‬ ‫حسناء‬33--‫على‬ ‫محمد‬ ‫مجدى‬ ‫لقاء‬‫على‬ ‫محمد‬ ‫مجدى‬ ‫لقاء‬44--‫سعيد‬ ‫محمود‬ ‫شيرين‬‫سعيد‬ ‫محمود‬ ‫شيرين‬55--‫جاويش‬ ‫تفيد‬ ‫ايمن‬‫جاويش‬ ‫تفيد‬ ‫ايمن‬66--‫محمد‬ ‫فؤاد‬ ‫محمد‬‫محمد‬ ‫فؤاد‬ ‫محمد‬77--(‫نفسى‬ ‫)اخصائى‬ ‫الغنام‬ ‫محمد‬ ‫ريهام‬(‫نفسى‬ ‫)اخصائى‬ ‫الغنام‬ ‫محمد‬ ‫ريهام‬‫رامى‬ ‫هشام‬ /.‫ا.د‬ :‫العام‬ ‫المشرف‬‫رامى‬ ‫هشام‬ /.‫ا.د‬ :‫العام‬ ‫المشرف‬
  6. 6. Abbassia Psychiatry Hospital, training sectionAbbassia Psychiatry Hospital, training section‫الثالث‬ ‫المشروع‬‫الثالث‬ ‫المشروع‬::“Prevalence of Personality Disorders in the Addict Population”“Prevalence of Personality Disorders in the Addict Population”Case-Control StudyCase-Control StudySample Size (120)Sample Size (120)Tools: SCID-IITools: SCID-IIAddiction Section- Abbasseya Hospital for Mental HealthAddiction Section- Abbasseya Hospital for Mental Health:‫العمل‬ ‫فريق‬:‫العمل‬ ‫فريق‬11--(‫البحث‬ ‫)منسق‬ ‫اسماعيل‬ ‫مسعد‬ ‫خالد‬(‫البحث‬ ‫)منسق‬ ‫اسماعيل‬ ‫مسعد‬ ‫خالد‬22--‫فهيم‬ ‫كامل‬ ‫ديفيد‬‫فهيم‬ ‫كامل‬ ‫ديفيد‬33--‫الحمد‬ ‫ابو‬ ‫محمد‬‫الحمد‬ ‫ابو‬ ‫محمد‬44--‫المجد‬ ‫ابو‬ ‫هناء‬‫المجد‬ ‫ابو‬ ‫هناء‬55--‫اسماعيل‬ ‫سيد‬ ‫بسنت‬‫اسماعيل‬ ‫سيد‬ ‫بسنت‬66--(‫نفسى‬ ‫)اخصائى‬ ‫خيرى‬ ‫دعاء‬(‫نفسى‬ ‫)اخصائى‬ ‫خيرى‬ ‫دعاء‬‫البحيرى‬ ‫احمد‬ /‫د‬ :‫العام‬ ‫المشرف‬‫البحيرى‬ ‫احمد‬ /‫د‬ :‫العام‬ ‫المشرف‬
  7. 7. Abbassia Psychiatry Hospital, training sectionAbbassia Psychiatry Hospital, training section Of course ,each training project might beOf course ,each training project might besupervised and completed by its supervisor andsupervised and completed by its supervisor andlisted team work.listed team work. In this lecture , it is a facilitation to do the 1In this lecture , it is a facilitation to do the 1stststep , of designing a research and write astep , of designing a research and write aprotocol .protocol .
  8. 8. Steps of Writing a ProtocolSteps of Writing a Protocol
  9. 9. AA  Research Proposal ( ProtocolResearch Proposal ( Protocol))   is a document written by a researcher thatis a document written by a researcher thatprovides a detailed description of the proposedprovides a detailed description of the proposedprogram.program. It is like an outline of the entire researchIt is like an outline of the entire researchprocess that gives a reader a summary of theprocess that gives a reader a summary of theinformation discussed in a project.information discussed in a project.
  10. 10. StepsSteps1- Title page.1- Title page.2- Introduction.2- Introduction.3- The aims.3- The aims.4- The hypothesis.4- The hypothesis.5- Methodology ( materials and method )5- Methodology ( materials and method )( method of investigation).( method of investigation).6- Bibliography ,References.6- Bibliography ,References.7- Arabic Summary.7- Arabic Summary.8- Arabic title page.8- Arabic title page.
  11. 11. 11--Title pageTitle pageIncludes :Includes : Title :Title : must be discussed well , as it must be mostmust be discussed well , as it must be mostrelated and carries the main concept , according to therelated and carries the main concept , according to thereview, hypothesis, and aim of the work.review, hypothesis, and aim of the work. Name and short C.V , of the principal investigator.Name and short C.V , of the principal investigator. Name and short C.V, of the team work researchers.Name and short C.V, of the team work researchers. Date of action , usually M. and Yr. only.Date of action , usually M. and Yr. only.
  12. 12. 22--IntroductionIntroduction It shows the background of the project.It shows the background of the project. The most important feature of the background to the project isThe most important feature of the background to the project isthat it should be brief and to the point. For a research protocolthat it should be brief and to the point. For a research protocolthe background should be no longer than two pages of A4 paper.the background should be no longer than two pages of A4 paper.   you should concisely review the literature that is relevant to theyou should concisely review the literature that is relevant to theproblem that you are trying to solve. it is probably good practiceproblem that you are trying to solve. it is probably good practiceto limit the number of papers quoted to less than 20.to limit the number of papers quoted to less than 20. The literature review should logically lead to the statementThe literature review should logically lead to the statementof the aims of the proposed project.of the aims of the proposed project...
  13. 13. 33--The aimsThe aims The aims of the project should be explicitlyThe aims of the project should be explicitlystatedstated.. These should be confined to theThese should be confined to theintention of the project and they should ariseintention of the project and they should arisefrom the literature reviewfrom the literature review..
  14. 14. 44--The hypothesisThe hypothesis.. It s not important to write , if you write the aimsIt s not important to write , if you write the aimsin term of difference and relation.in term of difference and relation. The hypothesis that you are trying to proveThe hypothesis that you are trying to proveshould be stated in the simplest form possibleshould be stated in the simplest form possible.. It is general practice that hypotheses are statedIt is general practice that hypotheses are statedin the null ( N0 )form.in the null ( N0 )form.
  15. 15. 55--Methodology ( materials and method )Methodology ( materials and method )( method of investigation( method of investigation(( Sample size calculation .Sample size calculation . Design and type of sample, e.g random , case-control study.Design and type of sample, e.g random , case-control study. Subjects : criteria for groups ( numbers , inclusion andSubjects : criteria for groups ( numbers , inclusion andexclusion criteria ) .exclusion criteria ) . Site of research.Site of research. Dates of research, starting and closing.Dates of research, starting and closing. Prepare questionnaire, pilot study to pretest the questions.Prepare questionnaire, pilot study to pretest the questions.
  16. 16. 55--Methodology ( materials and method )Methodology ( materials and method )( method of investigation) – cont( method of investigation) – cont.. Tools and measurements used , appendix , with summarizedTools and measurements used , appendix , with summarizedexplanation.explanation. Procedures and their milestones. How, when, who, and whom .Procedures and their milestones. How, when, who, and whom . Prepare abstract sheet to collect data in separate variables.Prepare abstract sheet to collect data in separate variables. Statistical tests that researchers will use to analyze the data.Statistical tests that researchers will use to analyze the data. Method of dissemination of the results and findings. Not essential toMethod of dissemination of the results and findings. Not essential tobe done.be done. Resource required . Abbassia Psychiatry Hospital, training sectionResource required . Abbassia Psychiatry Hospital, training section
  17. 17. 66--Bibliography ,ReferencesBibliography ,References Each paper usually have a minimum of ten (10)Each paper usually have a minimum of ten (10)references of which 8 must be from periodicals.references of which 8 must be from periodicals. E.g., of reference from book:E.g., of reference from book:Calan J. and Bartas,A , “ Writing Medical Papers : aCalan J. and Bartas,A , “ Writing Medical Papers : aPractical Guide” Heinemann Medical Books Limited,Practical Guide” Heinemann Medical Books Limited,U.K.-1973.p26.U.K.-1973.p26. E.g., of reference from a periodical:E.g., of reference from a periodical:Weinman ER. (1978): “ Multiple Screening ofWeinman ER. (1978): “ Multiple Screening ofLongshoreman with Organized Medical Follow – up “Longshoreman with Organized Medical Follow – up “Amer J Public Health 42 : 1552-1567.Amer J Public Health 42 : 1552-1567.
  18. 18. THANKTHANKYOUYOU

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