DSS211 Study Design by Dr. Mai Salah El-Din PDF
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Mai Salah El-Din
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The document provides a summary of various types of epidemiological studies, such as experimental and observational ones. It also covers factors related to the validity of clinical trials, such as randomization techniques, control groups, and the concept and importance of blinding. Furthermore, the document presents examples of databases and medical publishers.
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STUDY DESIGN Lecturer. MAI SALAH EL-DIN BDs, MSc, PHD Study design:- I-Non-Intervention studies (Non experimental, Observational): -Where the researcher just describes or analyzes researchable objects or situations but does not intervene. II-Intervention studies (Experimental):...
STUDY DESIGN Lecturer. MAI SALAH EL-DIN BDs, MSc, PHD Study design:- I-Non-Intervention studies (Non experimental, Observational): -Where the researcher just describes or analyzes researchable objects or situations but does not intervene. II-Intervention studies (Experimental): -Where the researcher manipulates objects or situations ,either by preventive or therapeutic measures ,and determine the outcome of his manipulation. II-Intervention studies (Experimental): CLINICAL TRIAL Factors affecting the validity of the trial:- 1- Randomization: -Parallel design. 1)- Cross-Over design. 2)- Split-mouth design. 3)- Pretest and posttest (Before and after). 4)- External Control. 2- Control: a- Positive control. b- Negative control. c- Placebo. II-Intervention studies (Experimental): CLINICAL TRIAL Factors affecting the validity of the trial:- 3- Blinding Concept: a- Open-label. b- Single-Blinded. c- Double-Blinded. d- Triple-Blinded. 4- Sample size. 5- Follow- up period. 6- Inter and Intra- examiner reliability. Factors affecting the validity of the trial:- 4-Sample size: -If sample size is sufficient, all factors influential in the outcome are likely to be distributed equally between the groups which were randomly allocated. -Therefore, any difference in the observed outcome between the groups is likely to be due to the intervention. Factors affecting the validity of the trial:- 6: Follow- up period: -Clinical trial must be continued long enough to permit detection of new disease or extension of lesion already present during the trial: ex.: 1-For caries trial, minimum duration 2 years. 2-For plaque inhibiting agents trial, 8-21 days. 3-To demonstrate gingivitis reduction, 6 month 4-For calculus preventing agents should last 90 days for supra gingival calculus & longer for sub gingival calculus. Factors affecting the validity of the trial:- 7: Inter, Intra-examiner reliability test: -Reliability in diagnosis can be achieved by the inter & intra examiner reliability tests. 7: Intra, Inter-examiner reliability test: 7: Inter, Intra-examiner reliability test: 7: Inter, Intra-examiner reliability test: Database: Online database is accessible via web browser, and are hosted on website, as opposed to one that is stored locally on an individual computer. They maybe free or require payment, such as a monthly subscription. It provides access to multiple journals at a time. Publisher: Publishing company, organization, or an individual who leads to publishing company, imprint, periodical or newspaper. Database Ex. 1-Pubmed:The number one source for medical and healthcare research. 2-Cochrane library: The best known for its systematic reviews. 3-Pubmed Central (PMC): Open access branch of PubMed. It includes full-text versions for all indexed papers. 4- Science direct: Scientific medical publications. 5- Scopus: Scientific abstract and citations database. Database Ex. 6- Web of science. 7- EBSCO. 8- Researchgate: it is popular hub for sharing academic publications. 9-Google scholar: Web search engine, rather than database or library. Publisher ex. 1- Springer. 2- Elsevier. 3- Thieme medical publisher: The number one source for medical and healthcare research. Lecturer: MAI SALAH EL-DIN BDs, MSc, PHD