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Showing posts with label Epidemiology and Research 2020. Show all posts
Showing posts with label Epidemiology and Research 2020. Show all posts

200915P - IRB SERVICES OVERVIEW

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Presentation at an Online Research Program held on Tuesday, 15 September 2020 at 10:00 AM - 12:00 PM. By Professor Omar Hasan Kasule Sr. MB ChB (MUK), MPH (Harvard), DrPH (Harvard) Chairman of the Institutional Review Board

 

SCOPE OF RESEARCH: IRB Covers The Following Types Of Research:

· Research by clinical observation.

· Controlled clinical comparative research.

· Laboratory research.

· Epidemiological research.

· Genetic research.

· Qualitative research.

· Genetic research.

 

CORE FUNCTIONS OF IRB:

· Assessing and approving research on patients, volunteers, KFMC staff and human tissues.

· Assessing any research involving access to medical records with a potential to breach confidentiality.

· Monitoring the conduct of research to detect any ethical violations.

 

CORE FUNCTIONS OF IRB, con’t.:

· IRB oversight activities include monitoring full review IRB approved research yearly and monitoring the consent process.

o A continuing review process is integral to the audit and monitoring processes.

· Assuring protection of research subjects’ physical and mental well-being as stipulated in the Helsinki Declaration.

· Protection of the researchers and the institution in which they work by advising them about ethical conduct so that they do not commit.

 

OTHER IRB FUNCTIONS:

· Issue letters to heads of department to allow researchers.

· Issue letters to security to allow external researchers to enter KFMC.

· Certification of various issues to sponsors and other agencies.

· Approval of manuscripts for publication.

· General advice on research methods for researchers.

 

200204P - CRITICAL READING OF A JOURNAL ARTICLE

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Presented at CRC course held at King Fahad Medical City, Riyadh on 26 January 2020. 11:00 am - 12:00 pm by Professor Omar Hasan Kasule Sr. MB ChB (MUK). MPH (Harvard), DrPH (Harvard) Chairman of the Institutional Review Board, King Fahad Medical City

 

INTRODUCTION:

} For a critical reading of scientific literature, the reader must be equipped with tools to analyze their methodology and data analysis critically before accepting their conclusions.

} Common problems in published studies are incomplete documentation, design deficiencies, improper significance testing and interpretation.

 

ISSUES IN THE TITLE:

} The main problem of the title is irrelevance to the body of the article.

} Too long and too short.

} Title lacking key words of the research.

 

PROBLEMS OF THE ABSTRACT:

} Failure to show the focus of the study.

} Failure to provide sufficient information to assess the study (design, analysis, and conclusions).

} Focusing on only one part of the study.

} Including literature review and taking much space.

 

PROBLEMS OF THE INTRODUCTION:

} Failure to state the reason for the study.

} Failure to review previous studies, succinct and relevant.

} The laundry list of previous studies.

} Failure to point out the gap in knowledge and the contribution of the present study.

} Failure to provide the background and historical perspective.

} Failure to state the study population.

} Failure to state the study hypothesis.

 

PROBLEMS OF STUDY DESIGN:

} Going on a fishing expedition without a prior hypothesis.

} Study design not appropriate for the hypothesis tested.

} Lack of a comparison group.

} Use of an inappropriate comparison group.

} The Berkson's fallacy.

} Selection of cases and controls from different populations.

} Sample size not big enough to answer the research questions.

 

PROBLEMS OF CONFUSED TERMINOLOGY:

} ‘Measurement’ uses instruments. ‘Calculation’ deals with numbers and formulas.

} ‘Estimation’ is used in two senses as an approximation in measurements or as computation of statistical parameters.

} ‘Determination’ is a general term for getting to a conclusion by use of the 4 methods above.

} The term ‘study’ is generic and can be confused with experiment that refers to only some types of studies.


PROBLEMS IN DATA COLLECTION:

} Missing data due to incomplete coverage,

} Loss of information due to censoring and loss to follow-up,

} Poor documentation of data collection,

} Methods of data collection inappropriate to the study design.

 

PROBLEMS OF DATA ANALYSIS:

} Failures to state the type of hypothesis testing (p value or confidence interval).

} Use of the wrong statistical tests mostly because of confusing discrete and continuous data.

} Drawing inappropriate conclusions.

} Use of parametric tests for non-normal data.

} Multiple comparisons or multiple significance testing.

} Failure to assess errors.

} Failure to assess normality of data.

} Failure to use the appropriate data scale: qualitative/quantitative/discrete/continuous.

} Using the wrong statistical formula.

 

PROBLEMS IN REPORTING RESULTS:

} Selective reporting of favorable results,

} Numerators without denominator,

} Inappropriate denominators,

} Numbers that do not add up,

} Tables not labeled properly or completely,

} Numerical inconsistency (rounding, decimals, and units),

} Stating results as mean +/- 2sd for non-normal data,

} Stating p values as inequalities instead of the exact values,

} Missing degrees of freedom and confidence limits.

 

PROBLEMS OF THE CONCLUSION - 1:

} Repeating the results section,

} Failure to discuss the consistency of conclusions with the data and the hypothesis,

} Extrapolations beyond the data,

} Failure to discuss short-comings and limitations of the study,

} Failure to evaluate statistical conclusions in view of testing errors,

} Failure to assess bias (misclassification, selection, and confounding).

 

PROBLEMS OF THE CONCLUSION - 2:

} Failure to assess precision (lack of random error), and assessment of validity (lack of systematic error).

} Failure to appreciate the difference between internal and external validity: Internal validity is achieved when the study is internally consistent and the results and conclusions reflect the data. External validity is generalizability (i.e. how far can the findings of the present study be applicable to other situations) and is achieved by several independent studies showing the same result.

} Inability to detect the outcome of interest due to insufficient period of follow-up, inadequate sample size, and inadequate power.

 

ABUSE OR MISUSE OF STATISTICS:

} Incomplete and inaccurate documentation of results.

} Selection of a favorable rate and ignoring unfavorable ones. This is done by 'playing' either with the numerator or the denominator.

} The scales of numerators and denominators can be made artificially wider or narrower giving false and misleading impressions.

 

MISLEADING STATISTICS:

} Violating the principle of parsimony.

} Study objective unclear and not reflected in the study hypothesis.

} Fuzzy, inconsistently, and subjective definitions (of cases, non-cases, the exposed, the non-exposed, comparison groups, exposure, method of measurement).

} Incomplete information on response rates and missing data.

  

201227P - IDENTIFYING HEALTH PROBLEMS AND CHOOSING RESEARCH PRIORITIES

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Presentation at a workshop on Research Methodology in Health Sciences held at the Northern Area Armed Forces Hospital on 27 December 2020 at 4:20pm. By Professor Omar Hasan Kasule Sr. MB ChB (MUK). MPH (Harvard), DrPH (Harvard)

 

 

1.0 IDENTIFYING HEALTH PROBLEMS BY MEASUREMENT OF DISEASE INCIDENCE:

}  New disease is measured by incidence.

}  Incidence rate (IR) = incident number/ total person-time.

}  Cumulative incidence = incident number / susceptible population at the start.

 

2.0 IDENTIFYING HEALTH PROBLEMS BY MEASUREMENT OF DISEASE PREVALENCE:

} Existing disease is measured by prevalence.

} Prevalence proportion = # cases of illness at a particular time (old and new) / # of individuals in the population at the same time.

} Prevalence can be point, period, and lifetime prevalence.

} Prevalence proportion = incidence rate x average duration of disease.

} Prevalence is useful for administrative purposes.

} Prevalence is not used for etiological studies because the time sequence is not obvious. Prevalence changes due to changes in incidence and duration.

 

3.0 IDENTIFYING HEALTH PROBLEMS BY MEASURING EXCESS DISEASE (Odds Ratio):

}  OR up to 0.3 = strong benefit,

}  OR 0.4 – 0.5 = moderate benefit,

}  OR 0.6 – 0.8 = weak benefit,

}  OR 0.9 – 1.1 = no effect,

}  OR 1.2 –1.6 = weak hazard,

}  OR 1.7 –2.5 = moderate hazard,

}  OR >=2.6 = strong hazard.

 

4.0 IDENTIFYING HEALTH PROBLEMS BY MEASURING DISEASE IMPACT:

} Life expectancy at birth.

} A common measure of disease impact is the years of potential life lost (YPLL).

} YPLL is the number of years a person would have lived if he did not die prematurely

} Premature death is generally considered below 65 years.

} QUALITY ADJUSTED LIFE YEAR (QUALY) is a generic measure of disease burden combining quantity and quality of life. I QUALY = 1 year in perfect health

} DISABILITY ADJUSTED LIFE YEARS (DALY) is an overall measure of overall disease burden. 1 DALY = loss of the equivalent of one year of full health.

 

5.0  DETERMINING RESEARCH PRIORITIES BY ASKING VITAL QUESTIONS:

}  Does a health problem exist?: Is there a gap between the actual and the ideal? Are the reasons for the gap not clear? Is potentially more than one solution possible?

}  What information needed to define a research question?: 1. Information on present health status 2. Information to evaluate on-going interventions 3. information to define problems.

}  What criteria used to prioritize among research questions: 1. relevance 2. urgency 3. political acceptability 4. feasibility of study 7. applicability of results 8. ethical acceptability

 

6.0 SELECTING RESEARCH PRIORITIES BY THE NOMINAL GROUP TECHNIQUE - 1: Process

}  Individuals list their ideas on paper,

}  Lists are displayed and are grouped,

}  Voting and ranking,

}  Scoring and re-discussion,

}  Second vote and re-ranking

 

7.0 SELECTING RESEARCH PRIORITIES BY THE NOMINAL GROUP TECHNIQUE - 2: Advantages

}  Separation of discussion from voting,

}  Voting is anonymous,

}  Results indicate input from all members,

}  Voting aggregates individual judgments

 

8.0 STEPS IN HEALTH PROBLEM ANALYSIS:

}  Obtaining views of managers and health care workers.

}  Specification of the core problem(s).

}  Triangulation, looking at a problem from various angles.

}  Listing factors of the problem, the relation between the problem and the factors and the interrelations among factors.

}  Grouping factors as: socio-cultural, economic, service related, disease related. 6. Constructing a problem analysis diagram.

 

9.0 STATING THE HEALTH PROBLEM:

}  Socio-cultural and economic background to the problem.

}  Health status assessment.

}  Nature of the problem: how, who, when, where, how.

}  Solutions tried in the past.

}  Justification for new research.

}  Type of information needed.

}  Definition of crucial terms and concepts.

 

10.0 FORMULATION OF RESEARCH OBJECTIVES:

}  Types of research objectives: 1. general 2. specific.

}  Advantages of stating research objectives: 1. focusing the study 2. avoiding unnecessary data collection 3. organizing the study in parts/phases.

}  Guidelines for writing objectives: 1. coherent and in logical sequence 2. in operational terms 3. realistic 4. action verbs.

}  Research title: 1. must be concise 2.  must reflect objectives.

 

11.0 RESEARCH HYPOTHESES:

} Types of hypotheses: 1. null hypothesis 2. alternative hypothesis.

} Hypotheses based on causal relations.

} Criteria of causality (sababiyyat) by Bradford Hill: strength of association, consistency, specificity, temporarity, biological gradient, plausibility, coherence, experiment, analogy).

} Advantage of hypothesis-based research: 1. Research based on hypotheses is more powerful than research based only on stating problems. 2. avoiding fishing trip findings.