how to design a protocol for medical research

How to Design a How to Design a Protocol for Medical Protocol for Medical

ResearchResearch(research proposal),(research proposal),

Abbassia Psychiatry Hospital, Abbassia Psychiatry Hospital,

training sectiontraining section Dr. Ahmed ALbehairy, M.DDr. Ahmed ALbehairy, M.D

Consultant of Psychiatry, Consultant of Psychiatry, MOH, EgyptMOH, Egypt

Abbassia Psychiatry Hospital, training Abbassia Psychiatry Hospital, training sectionsection

In need for training a group of working staff In need for training a group of working staff ( psychiatrists and psychologists ) , in ( psychiatrists and psychologists ) , in

research methodology .research methodology .

Aims to participate and share with others, Aims to participate and share with others, interested organizations, in forming a data interested organizations, in forming a data base of psychiatry in Egypt .base of psychiatry in Egypt .

Also , aims to improve patients’ care Also , aims to improve patients’ care through more understanding of research through more understanding of research and to get a critical thinkers personnel , do and to get a critical thinkers personnel , do study design and do statistics. study design and do statistics.


Approaching our aims , a work shop Approaching our aims , a work shop in medical research has been held, in medical research has been held, in Abbassia psychiatry hospital, on in Abbassia psychiatry hospital, on 28 –29- 30 may 2013.28 –29- 30 may 2013.

21 personnel of our staff attended 21 personnel of our staff attended the workshop.the workshop.


Continuing to prepare the emerging research team Continuing to prepare the emerging research team in abbassia , 3 training projects have been allocated in abbassia , 3 training projects have been allocated as follow:as follow:

االول االول المشروع ::المشروع“Burden on Families of Adolescents diagnosed with “Burden on Families of Adolescents diagnosed with Psychiatric Disorders”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 فريق

11 - -) البحث ) منسق حسن محمود (حسن البحث ) منسق حسن محمود حسنالوهاب - - 22 عبد الوهاب اسماء عبد اسماء

فرج - - 33 فرج اكرم اكرمحماد - - 44 حماد عبدالرحمن عبدالرحمن

عبدالحميد - - 55 صالح عبدالحميد محمد صالح محمدلطفى - - 66 عبدالعزيز لطفى رنا عبدالعزيز رنا

77 - -) نفسى ) اخصائى عبدالخالق احمد (عبير نفسى ) اخصائى عبدالخالق احمد عبير / : على السميع عبد ريهام د العام / المشرف : على السميع عبد ريهام د العام المشرف


الثانى الثانى المشروع ::المشروع“Effectiveness of Parent Training Program for Adolescents “Effectiveness of Parent Training Program for Adolescents diagnosed with Conduct Disorders”diagnosed with 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 Population: candidates with conduct disorder from 1/6/2013 to 31/12/201331/12/2013Adolescence Clinic - Abbasseya Hospital for Mental HealthAdolescence Clinic - Abbasseya Hospital for Mental Health: العمل :فريق العمل فريق

11 - -) البحث ) منسق عراقى (صفاء البحث ) منسق عراقى صفاءشاهين - - 22 احمد شاهين حسناء احمد حسناء

على - - 33 محمد مجدى على لقاء محمد مجدى لقاءسعيد - - 44 محمود سعيد شيرين محمود شيرين

جاويش - - 55 تفيد جاويش ايمن تفيد ايمنمحمد - - 66 فؤاد محمد محمد فؤاد محمد

77 - -) نفسى ) اخصائى الغنام محمد (ريهام نفسى ) اخصائى الغنام محمد ريهام /. . : رامى هشام د ا العام ./ المشرف . : رامى هشام د ا العام المشرف


الثالث الثالث المشروع ::المشروع“Prevalence of Personality Disorders in the Addict “Prevalence of Personality Disorders in the Addict Population”Population”Case-Control StudyCase-Control StudySample Size (120)Sample Size (120)Tools: SCID-IITools: SCID-IIAddiction Section- Abbasseya Hospital for Mental Addiction Section- Abbasseya Hospital for Mental HealthHealth: العمل :فريق العمل فريق

11 - -) البحث ) منسق اسماعيل مسعد (خالد البحث ) منسق اسماعيل مسعد خالدفهيم - - 22 كامل فهيم ديفيد كامل ديفيد

الحمد - - 33 ابو الحمد محمد ابو محمدالمجد - - 44 ابو المجد هناء ابو هناء

اسماعيل - - 55 سيد اسماعيل بسنت سيد بسنت66 - -) نفسى ) اخصائى خيرى (دعاء نفسى ) اخصائى خيرى دعاء

/ : البحيرى احمد د العام / المشرف : البحيرى احمد د العام المشرف


Of course ,each training project Of course ,each training project might be supervised and completed might be supervised and completed by its supervisor and listed team by its supervisor and listed team work.work.

In this lecture , it is a facilitation to In this lecture , it is a facilitation to do the 1do the 1stst step , of designing a step , of designing a research and write a protocol .research and write a protocol .

Steps of Writing a ProtocolSteps of Writing a Protocol

AA Research Proposal Research Proposal ( Protocol)( Protocol)

is a document written by a is a document written by a researcher that provides a detailed researcher that provides a detailed description of the proposed description of the proposed program.program.

It is like an outline of the entire It is like an outline of the entire research process that gives a reader research process that gives a reader a summary of the information a summary of the information discussed in a project. discussed in a project.

StepsSteps

1- 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 - -Title pageTitle page

Includes :Includes : Title :Title : must be discussed well , as it must must be discussed well , as it must

be most related and carries the main be most related and carries the main concept , according to the review, concept , according to the review, hypothesis, and aim of the work.hypothesis, and aim of the work.

Name and short C.V , of the principal Name and short C.V , of the principal investigator. investigator.

Name and short C.V, of the team work Name and short C.V, of the team work researchers.researchers.

Date of action , usually M. and Yr. only.Date of action , usually M. and Yr. only.

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 most important feature of the background to the project is that it should be brief and to the the project is that it should be brief and to the point. For a research protocol the background point. For a research protocol the background should be no longer than two pages of A4 paper. should be no longer than two pages of A4 paper.

you should concisely review the literature that is you should concisely review the literature that is relevant to the problem that you are trying to relevant to the problem that you are trying to solve. it is probably good practice to limit the solve. it is probably good practice to limit the number of papers quoted to less than 20. number of papers quoted to less than 20.

The literature review should logically lead to The literature review should logically lead to the statement of the aims of the proposed the statement of the aims of the proposed project.project...

33 - -The aimsThe aims

The aims of the project should be The aims of the project should be explicitly statedexplicitly stated. . These should be These should be confined to the intention of the confined to the intention of the project and they should arise from project and they should arise from the literature reviewthe literature review..

44 - -The hypothesisThe hypothesis..

It s not important to write , if you It s not important to write , if you write the aims in term of difference write the aims in term of difference and relation.and relation.

The hypothesis that you are trying to The hypothesis that you are trying to prove should be stated in the prove should be stated in the simplest form possiblesimplest form possible..

It is general practice that It is general practice that hypotheses are stated in the null hypotheses are stated in the null ( N0 )form.( N0 )form.

55 - -Methodology ( materials and Methodology ( materials and method )method )

( method of investigation) ( method of investigation)

Sample size calculation .Sample size calculation .

Design and type of sample, e.g random , case-Design and type of sample, e.g random , case-control study.control study.

Subjects : criteria for groups ( numbers , Subjects : criteria for groups ( numbers , inclusion and exclusion criteria ) . inclusion and 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 Prepare questionnaire, pilot study to pretest the questions.questions.

55 - -Methodology ( materials and Methodology ( materials and method )method )

( method of investigation) – cont ( method of investigation) – cont..

Tools and measurements used , appendix , with Tools and measurements used , appendix , with summarized explanation.summarized explanation.

Procedures and their milestones. How, when, who, and Procedures and their milestones. How, when, who, and whom .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 Statistical tests that researchers will use to analyze the data.data.

Method of dissemination of the results and findings. Not Method of dissemination of the results and findings. Not essential to be done.essential to be done.

Resource required . Abbassia Psychiatry Hospital, training Resource required . Abbassia Psychiatry Hospital, training sectionsection

66 - -Bibliography ,ReferencesBibliography ,References Each paper usually have a minimum of ten Each paper usually have a minimum of ten

(10) references of which 8 must be from (10) references of which 8 must be from periodicals.periodicals.

E.g., of reference from book:E.g., of reference from book:Calan J. and Bartas,A , “ Writing Medical Papers Calan J. and Bartas,A , “ Writing Medical Papers

: a Practical Guide” Heinemann Medical : a Practical Guide” Heinemann Medical Books Limited, U.K.-1973.p26.Books Limited, U.K.-1973.p26.

E.g., of reference from a periodical:E.g., of reference from a periodical:Weinman ER. (1978): “ Multiple Screening of Weinman ER. (1978): “ Multiple Screening of

Longshoreman with Organized Medical Longshoreman with Organized Medical Follow – up “ Amer J Public Health 42 : 1552-Follow – up “ Amer J Public Health 42 : 1552-1567.1567.

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how to design a protocol for medical research

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