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Critical evaluation of drugs.pptx by queeny

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Critical evaluation

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CRITICAL EVALUATION OF DRUG INFORMATION AND LITERATURE ? DRUG LITERATURE EVALUATION: ? Among the skills of drug Information is knowledge of drug literature evaluation which allows one to provide a critical analysis of the literature and have a better understanding of the studies done in health and medicine. ? It is a key component to provide a good quality answer to a requester. ? Being able to separate good data from poor data is essential. ? Knowing the limitations of any study can help in evaluating the usability of its data. ? Drug information specialists will often use some standard questions to help in this process. ? Several references provide guides to evaluate the medical and pharmacy literature.
? NEED OF THE LITERATURE EVALUATION: ? Increasing sophisticated patient population who educate themselves about drug therapy (from various sources such as healthcare professionals, purveyors of alternative meds, family and friends), internet and reading some medical literatures and lay press. ? The physicians and other health care often contact the pharmacist for opinion on various aspects of the therapy. ? Addition and deletion of the drugs from the formulary. ? These responses can only be made after careful analysis of the available studies by the pharmacist.
? REASON OF FLAWS AND BIAS IN THE LITERATURES PUBLISHED: ? Quantity of publication to become tenured academicians may lead to an attempt to publish suboptimal quality publication or same study in more than one journal orNportions ofthe same study in multiple journals. ? Researchers may have lack of knowledge in study design and statistical analysis to perform well conducted study. Or maybe the reviewers of the journal may be deficient in such knowledge. ? Even if the peer reviewers recognize the flaw they may consider it worthy of publication if the research is in an area of importance and its publication may stimulate further investigations.
? LITERATURE EVALUATION: ? l. Title/ Abstract: ? Title of the article should be brief and catch the attention of the readers interested in the topic. And it should not be biased or indicate the authors preference's viz., "study on the superiority of drug A against drug B in xyz diseased patients. ? Abstract is the road map of a study. It is less time consummg and by scaning the abstracts, readers should be able to determme whether the study is of interest and deserves further reading. ? Some discrepancies regularly seen in the abstracts is that some data or numerical values mentioned in the abstract will not be discussed in the body of the article or will not be the same as the one given in the results of the study. ? Structured abstracts for clinical studies include the following sections: objective, research design, clinical setting, participants, Interventions, main outcome measurements, results, and discussion.
? 2. Introduction: ? This will contain the background information for the study and states study objectives and hypotheses. ? The background information states that the study is important and ethical. It familiarizes the readers with the research subject. Previous investigations and their limitations; need of the present study; and should clarify that the benefits of the study outweighs the risks tot eh patients entering the study. Superscriptions of references made for cross references. ? Study objectives or goals should be precise and clearly stated that it Will not confuse the readers and come to an erroneous conclusion regarding study results.
? The ill stated objective shows that the study was not well planned. ? Some studies state the null hypothesis and research hypothesis (researchers expect to find durmg the course of their study) in the introduction part. ? Ethical issues are either addressed in the introduction part or in the methodology part. ? This is to ensure that the risks to subjects are minimal and they know about the possible benefits and hazards of the study. Also mention regarding the Informed consent form if necessary.
? 3. Methodology: ? The most important section of a clinical study. ? Results of studies that show methodological flaws are unreliable. ? The main contents of the methodology can include: the research site, study period, ethical committee approval statement, study design, study population, instrumentation, and statistics used for the investigation.
? 4. Study Design: ? Two major types of study design seen in the true experiments: Parallel studies and Cross - Over studies. ? In parallel study the patients/ subjects (either the control or the treatment group) receives only one treatment throughout the study. Whereas In case of cross-over study subjects receive all study drugs. ? Parallel studies are appropriate in case when therapies are definitive or when disease states are self limited (e.g., antimicrobials for infectious diseases). ? Cross -over studies are appropnate in case diseases are chronic and/or variable (e.g.,glaucoma, migraine headache). In this study the error caused by variability among subjects are minimized since the each subject serves as his or her own control
? 5. Study Criteria: ? Inclusion criteria: ? List the subject characteristics that must be present for enrolment into the study. ? Exclusion criteria: ? List the characteristics in the target population that should not be included In the study. ? Subjects who are harmed by the therapy or who may confound the results of the study. ? Diagnosis criteria for the disease state should be clearly defined. (Climcal, laboratory and demographic criteria that justifies the diagnosis). ? The reader should check whether the enrolled subjects represent the patients routinely encountered in the clinical practice
? 6. Sample size: ? A sample is a subgroup from the entire population of patients With a particular disease state. ? Samples are used because of logistic, financial, and resource constraints that prohibit studying an entire population. ? The study needs a relevant sample size. Depends on the study objectives and design. ? Can be confident about the study in case the number of patients who completed the study equals the investigator's initial sample size calculations presented n the methodology.
? A discussion on the sample size calculation should be made by the investigator and whether the final number of subjects equals this calculation. ? Many Investigators add 10 20% ofthe sample size calculation keeping In mind about the drop outs or death of the subject that can happen during the study. ? In case of multicentre study it should be mentioned and make sure that the all the centres understand the protocol and receives adequate training in the conduct of trial. ? A minimum level of sample can be presented as pilot study that give nse to further research or hypotheses.
? Controls or Control groups: ? ?Two types of controls mainly used in the clinical trials: a) placebo control, and b)active control. ? Historical controls (retrospective data) are used In case the use of the previously used drug is no longer ethical. ? The criteria's and variables of the historical control should be similar to the current study. Time of data collection effects the patient response. ? All the interventions and care should be smilar in both the control and treatment group.
? Outcome variables: ? The variables to be measured and amount of difference between the treatment and control groups that the study is designed to detect should be clearly defined. ? The clinical outcomes should be relevant, clearly defined, objective, and clinically and biologically significant ? Instruments used to measure outcome variables should be justified. E.g., questionnaires, sensitivity and specificity of the instruments or techniques used, etc., ? Follow up time and length ofthe study should be mentioned.
? Randomization and Blinding: ? By randomization the subjects have an equal and independent chance of receiving any of the treatment modalities. ? Similar in regard to clinical and socioeconomic factors that may affect the treatment outcome. And diminishes the investigator and patient bias. ? Blinding: Single, Double or Triple blinding. This Improves the validity ofthe study. ? Statistical analysis: ? Errors in statistical analysis of data ate commonly encountered and invalidate the study
? 7. Results: ? Data should be presented in a clear and understandable format. ? Original data should be presented in case ofrequest from the reader. ? Data should present the actual numbers rather than percentage values since this can be use for the calculation purposes or the readers own analysis. ? Reasons for termination of study or reason of drop outs can be mentioned. ? Study validity whether the result was actual treatment related consequence and can it be generalized.
? 8. Conclusions/ Discussions: ? Interpretation of data and how it relates to the clinical practice. ? Consistent to the results and the initial study question. ? Study limitations can be mentioned ? 9. References: ? Used by the authors for support of the study. ? Limit the citing of own research efforts and publications. ? 10. Acknowledgments: ? Sources of funding and other support. ? Individuals who contributed to the research effort but do not qualify for authorship. ? Multicentre trials the investigational sites participating in the study should be listed.

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Critical evaluation of drugs.pptx by queeny

  • 1. CRITICAL EVALUATION OF DRUG INFORMATION AND LITERATURE ? DRUG LITERATURE EVALUATION: ? Among the skills of drug Information is knowledge of drug literature evaluation which allows one to provide a critical analysis of the literature and have a better understanding of the studies done in health and medicine. ? It is a key component to provide a good quality answer to a requester. ? Being able to separate good data from poor data is essential. ? Knowing the limitations of any study can help in evaluating the usability of its data. ? Drug information specialists will often use some standard questions to help in this process. ? Several references provide guides to evaluate the medical and pharmacy literature.
  • 2. ? NEED OF THE LITERATURE EVALUATION: ? Increasing sophisticated patient population who educate themselves about drug therapy (from various sources such as healthcare professionals, purveyors of alternative meds, family and friends), internet and reading some medical literatures and lay press. ? The physicians and other health care often contact the pharmacist for opinion on various aspects of the therapy. ? Addition and deletion of the drugs from the formulary. ? These responses can only be made after careful analysis of the available studies by the pharmacist.
  • 3. ? REASON OF FLAWS AND BIAS IN THE LITERATURES PUBLISHED: ? Quantity of publication to become tenured academicians may lead to an attempt to publish suboptimal quality publication or same study in more than one journal orNportions ofthe same study in multiple journals. ? Researchers may have lack of knowledge in study design and statistical analysis to perform well conducted study. Or maybe the reviewers of the journal may be deficient in such knowledge. ? Even if the peer reviewers recognize the flaw they may consider it worthy of publication if the research is in an area of importance and its publication may stimulate further investigations.
  • 4. ? LITERATURE EVALUATION: ? l. Title/ Abstract: ? Title of the article should be brief and catch the attention of the readers interested in the topic. And it should not be biased or indicate the authors preference's viz., "study on the superiority of drug A against drug B in xyz diseased patients. ? Abstract is the road map of a study. It is less time consummg and by scaning the abstracts, readers should be able to determme whether the study is of interest and deserves further reading. ? Some discrepancies regularly seen in the abstracts is that some data or numerical values mentioned in the abstract will not be discussed in the body of the article or will not be the same as the one given in the results of the study. ? Structured abstracts for clinical studies include the following sections: objective, research design, clinical setting, participants, Interventions, main outcome measurements, results, and discussion.
  • 5. ? 2. Introduction: ? This will contain the background information for the study and states study objectives and hypotheses. ? The background information states that the study is important and ethical. It familiarizes the readers with the research subject. Previous investigations and their limitations; need of the present study; and should clarify that the benefits of the study outweighs the risks tot eh patients entering the study. Superscriptions of references made for cross references. ? Study objectives or goals should be precise and clearly stated that it Will not confuse the readers and come to an erroneous conclusion regarding study results.
  • 6. ? The ill stated objective shows that the study was not well planned. ? Some studies state the null hypothesis and research hypothesis (researchers expect to find durmg the course of their study) in the introduction part. ? Ethical issues are either addressed in the introduction part or in the methodology part. ? This is to ensure that the risks to subjects are minimal and they know about the possible benefits and hazards of the study. Also mention regarding the Informed consent form if necessary.
  • 7. ? 3. Methodology: ? The most important section of a clinical study. ? Results of studies that show methodological flaws are unreliable. ? The main contents of the methodology can include: the research site, study period, ethical committee approval statement, study design, study population, instrumentation, and statistics used for the investigation.
  • 8. ? 4. Study Design: ? Two major types of study design seen in the true experiments: Parallel studies and Cross - Over studies. ? In parallel study the patients/ subjects (either the control or the treatment group) receives only one treatment throughout the study. Whereas In case of cross-over study subjects receive all study drugs. ? Parallel studies are appropriate in case when therapies are definitive or when disease states are self limited (e.g., antimicrobials for infectious diseases). ? Cross -over studies are appropnate in case diseases are chronic and/or variable (e.g.,glaucoma, migraine headache). In this study the error caused by variability among subjects are minimized since the each subject serves as his or her own control
  • 9. ? 5. Study Criteria: ? Inclusion criteria: ? List the subject characteristics that must be present for enrolment into the study. ? Exclusion criteria: ? List the characteristics in the target population that should not be included In the study. ? Subjects who are harmed by the therapy or who may confound the results of the study. ? Diagnosis criteria for the disease state should be clearly defined. (Climcal, laboratory and demographic criteria that justifies the diagnosis). ? The reader should check whether the enrolled subjects represent the patients routinely encountered in the clinical practice
  • 10. ? 6. Sample size: ? A sample is a subgroup from the entire population of patients With a particular disease state. ? Samples are used because of logistic, financial, and resource constraints that prohibit studying an entire population. ? The study needs a relevant sample size. Depends on the study objectives and design. ? Can be confident about the study in case the number of patients who completed the study equals the investigator's initial sample size calculations presented n the methodology.
  • 11. ? A discussion on the sample size calculation should be made by the investigator and whether the final number of subjects equals this calculation. ? Many Investigators add 10 20% ofthe sample size calculation keeping In mind about the drop outs or death of the subject that can happen during the study. ? In case of multicentre study it should be mentioned and make sure that the all the centres understand the protocol and receives adequate training in the conduct of trial. ? A minimum level of sample can be presented as pilot study that give nse to further research or hypotheses.
  • 12. ? Controls or Control groups: ? ?Two types of controls mainly used in the clinical trials: a) placebo control, and b)active control. ? Historical controls (retrospective data) are used In case the use of the previously used drug is no longer ethical. ? The criteria's and variables of the historical control should be similar to the current study. Time of data collection effects the patient response. ? All the interventions and care should be smilar in both the control and treatment group.
  • 13. ? Outcome variables: ? The variables to be measured and amount of difference between the treatment and control groups that the study is designed to detect should be clearly defined. ? The clinical outcomes should be relevant, clearly defined, objective, and clinically and biologically significant ? Instruments used to measure outcome variables should be justified. E.g., questionnaires, sensitivity and specificity of the instruments or techniques used, etc., ? Follow up time and length ofthe study should be mentioned.
  • 14. ? Randomization and Blinding: ? By randomization the subjects have an equal and independent chance of receiving any of the treatment modalities. ? Similar in regard to clinical and socioeconomic factors that may affect the treatment outcome. And diminishes the investigator and patient bias. ? Blinding: Single, Double or Triple blinding. This Improves the validity ofthe study. ? Statistical analysis: ? Errors in statistical analysis of data ate commonly encountered and invalidate the study
  • 15. ? 7. Results: ? Data should be presented in a clear and understandable format. ? Original data should be presented in case ofrequest from the reader. ? Data should present the actual numbers rather than percentage values since this can be use for the calculation purposes or the readers own analysis. ? Reasons for termination of study or reason of drop outs can be mentioned. ? Study validity whether the result was actual treatment related consequence and can it be generalized.
  • 16. ? 8. Conclusions/ Discussions: ? Interpretation of data and how it relates to the clinical practice. ? Consistent to the results and the initial study question. ? Study limitations can be mentioned ? 9. References: ? Used by the authors for support of the study. ? Limit the citing of own research efforts and publications. ? 10. Acknowledgments: ? Sources of funding and other support. ? Individuals who contributed to the research effort but do not qualify for authorship. ? Multicentre trials the investigational sites participating in the study should be listed.