The document provides an overview of different study designs used in epidemiology and public health research. It defines observational studies like cohort, case-control, and cross-sectional studies as well as experimental studies. It also includes examples to classify different study scenarios and provides definitions for key terminology related to research methodology and study design.
This is an easiest power-point slide you will get on topic Epidemiology. It’s basic of Epidemiology. This ppt includes difference between observational study & experimental study. Classification of Epidemiological study. You can read this & have an overview of Epidemiological study design in short. This power point will help you regarding understanding Epidemiological study. Including cohort study, case control study, descriptive study. This includes advantage & disadvantage of many studies of Epidemiological study design such ase cohort study, case control study, analytical study. It was our group presentation so we made with all our affords. I was the leader of our team I can assure you, you won’t get disappointment after studying this slides.
Clinical Research Regulation:
Various types of Clinical Study, Phases of Clinical Trial, Clinical Trial Protocol..
Drug discovery and development together are the complete process of identifying a new drug and bringing it to market.
Discovery may involve
Screening of chemical libraries
Identification of the active ingredient from a natural remedy.
Design resulting from an understanding of the target.
Development includes 0
Studies on microorganisms and animals.
Analytical method development and validation
Clinical trials and ultimately regulatory approval.
Drug Development/Approval Process..
Types of Clinical Study: Descriptive and Analytical..
Difference between Case Control and Cohort Study
Phases of Clinical Study
Phase 0: Phase 0 includes exploratory, first-in-human (FIH) trials that are carried out in accordance with FDA regulations.
The single subtherapeutic doses are administered to 10 to 15 volunteers in phase 0 trials, which are also known as human micro dose studies. These trials provide pharmacokinetic data or aid in the imaging of certain targets without causing pharmacological effects.
Phase 1: The initial evaluation of a medicine is done in phase I studies, which use fewer healthy human participants.
Phase 1 typically involves 20 to 80 healthy volunteers who have the illness or condition. Patients are often only utilized when a drug's mechanism of action indicates that healthy individuals will not tolerate it.
Nonetheless, researchers carry out Phase 1 studies in patients with that particular form of diabetes if a new medication is recommended for use in diabetic patients.
Phase 2: The purpose of phase II studies, which involve larger patient populations (a few hundreds), is to confirm the results of phase I safety evaluations and examine the drug's efficacy.
These tests are insufficient to determine whether the medicine will be effective in treating patients.
Phase 3: Researchers plan Phase 3 studies to prove whether a product deals an action benefit to a specific people or not.
Sometimes known as pivotal studies/ pilot, these studies comprise 300 to 3,000 volunteers.
Phase 3 studies deliver most of the safety data.
Phase 4: Phase 4 trials are conducted when the drug or device has been approved by FDA.
These trials are also recognized as post-marketing surveillance involving pharmacovigilance and continuing technical support after approval.
There are numerous observational strategies and assessment patterns used in Phase 4 trials to evaluate the efficacy, cost-effectiveness, and safety of an involvement in real-world settings.
This is an easiest power-point slide you will get on topic Epidemiology. It’s basic of Epidemiology. This ppt includes difference between observational study & experimental study. Classification of Epidemiological study. You can read this & have an overview of Epidemiological study design in short. This power point will help you regarding understanding Epidemiological study. Including cohort study, case control study, descriptive study. This includes advantage & disadvantage of many studies of Epidemiological study design such ase cohort study, case control study, analytical study. It was our group presentation so we made with all our affords. I was the leader of our team I can assure you, you won’t get disappointment after studying this slides.
Clinical Research Regulation:
Various types of Clinical Study, Phases of Clinical Trial, Clinical Trial Protocol..
Drug discovery and development together are the complete process of identifying a new drug and bringing it to market.
Discovery may involve
Screening of chemical libraries
Identification of the active ingredient from a natural remedy.
Design resulting from an understanding of the target.
Development includes 0
Studies on microorganisms and animals.
Analytical method development and validation
Clinical trials and ultimately regulatory approval.
Drug Development/Approval Process..
Types of Clinical Study: Descriptive and Analytical..
Difference between Case Control and Cohort Study
Phases of Clinical Study
Phase 0: Phase 0 includes exploratory, first-in-human (FIH) trials that are carried out in accordance with FDA regulations.
The single subtherapeutic doses are administered to 10 to 15 volunteers in phase 0 trials, which are also known as human micro dose studies. These trials provide pharmacokinetic data or aid in the imaging of certain targets without causing pharmacological effects.
Phase 1: The initial evaluation of a medicine is done in phase I studies, which use fewer healthy human participants.
Phase 1 typically involves 20 to 80 healthy volunteers who have the illness or condition. Patients are often only utilized when a drug's mechanism of action indicates that healthy individuals will not tolerate it.
Nonetheless, researchers carry out Phase 1 studies in patients with that particular form of diabetes if a new medication is recommended for use in diabetic patients.
Phase 2: The purpose of phase II studies, which involve larger patient populations (a few hundreds), is to confirm the results of phase I safety evaluations and examine the drug's efficacy.
These tests are insufficient to determine whether the medicine will be effective in treating patients.
Phase 3: Researchers plan Phase 3 studies to prove whether a product deals an action benefit to a specific people or not.
Sometimes known as pivotal studies/ pilot, these studies comprise 300 to 3,000 volunteers.
Phase 3 studies deliver most of the safety data.
Phase 4: Phase 4 trials are conducted when the drug or device has been approved by FDA.
These trials are also recognized as post-marketing surveillance involving pharmacovigilance and continuing technical support after approval.
There are numerous observational strategies and assessment patterns used in Phase 4 trials to evaluate the efficacy, cost-effectiveness, and safety of an involvement in real-world settings.
From History to Application Procedure OF CLINICAL TRIALS IN INDIA. PHASES 0,1,2,3,4 & 5.IMPORTANCE, advantages, guidelines global and India. Types, Design & blinding technique.
The randomised controlled trial (RCT) .pptxPRITIBISANE
Randomized controlled trials (RCT) are prospective studies that measure the effectiveness of a new intervention or treatment.
Randomization reduces bias and provides a rigorous tool to examine cause-effect relationships between an intervention and outcome
- يعتبر تقييم نتائج غازات الدم الشرياني (ABG) مصدر إزعاج للعديد من الطلاب والأطباء المبتدئين حيث يتم تعلمها بشكل سيئ أو يتم تدريسها بشكل سيء.
- تحليل غازات الدم هو أداة تساعد على التشخيص، وليست تشخيصية، وهي شائعة الاستخدام لتقييم الضغوط الجزئية للغاز في الدم ومحتوى القاعدة الحمضية.
- يتيح فهم تحليل غازات الدم واستخدامه لمقدمي الخدمات تفسير اضطرابات الجهاز التنفسي والدورة الدموية والتمثيل الغذائي.
- يمكن إجراء "تحليل غازات الدم" على الدم المأخوذ من أي مكان في الدورة الدموية (الشريان أو الوريد أو الشعيرات الدموية).
- ارتباط تفسير نتائج غازات الدم الشرياني (ABG) مرتبط ارتباطا وثيقا بالحالة الاكلينيكية للمريض ولا يمكن فصلهما بحال.
- اختبار غازات الدم الشرياني (ABG) بشكل صريح للدم المأخوذ من الشريان. يقيم تحليل ABG ضغط المريض الجزئي للأكسجين (PaO2) وثاني أكسيد الكربون (PaCO2). يوفر PaO2 معلومات عن حالة الأوكسجين ، ويقدم PaCO2 معلومات عن حالة التهوية (فشل تنفسي مزمن أو حاد) يتأثر PaCO2 بفرط التنفس (التنفس السريع أو العميق) ، ونقص التهوية (التنفس البطيء أو الضحل)، وحالة القاعدة الحمضية. على الرغم من أنه يمكن تقييم الأكسجين والتهوية بطريقة غير جراحية عن طريق قياس التأكسج النبضي ومراقبة ثاني أكسيد الكربون في نهاية المد ، على التوالي ، فإن تحليل ABG هو المعيار.
- فمن المثير ألا ينزعج الطبيب أو الممرضة اذا وجد صعوبة في تفسير بعض النتائج لغازات الدم.
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Similar to Writing the research protocol part 2- Methodology-Dr. Yasser Mohammed Hassanain Elsayed.pptx
From History to Application Procedure OF CLINICAL TRIALS IN INDIA. PHASES 0,1,2,3,4 & 5.IMPORTANCE, advantages, guidelines global and India. Types, Design & blinding technique.
The randomised controlled trial (RCT) .pptxPRITIBISANE
Randomized controlled trials (RCT) are prospective studies that measure the effectiveness of a new intervention or treatment.
Randomization reduces bias and provides a rigorous tool to examine cause-effect relationships between an intervention and outcome
- يعتبر تقييم نتائج غازات الدم الشرياني (ABG) مصدر إزعاج للعديد من الطلاب والأطباء المبتدئين حيث يتم تعلمها بشكل سيئ أو يتم تدريسها بشكل سيء.
- تحليل غازات الدم هو أداة تساعد على التشخيص، وليست تشخيصية، وهي شائعة الاستخدام لتقييم الضغوط الجزئية للغاز في الدم ومحتوى القاعدة الحمضية.
- يتيح فهم تحليل غازات الدم واستخدامه لمقدمي الخدمات تفسير اضطرابات الجهاز التنفسي والدورة الدموية والتمثيل الغذائي.
- يمكن إجراء "تحليل غازات الدم" على الدم المأخوذ من أي مكان في الدورة الدموية (الشريان أو الوريد أو الشعيرات الدموية).
- ارتباط تفسير نتائج غازات الدم الشرياني (ABG) مرتبط ارتباطا وثيقا بالحالة الاكلينيكية للمريض ولا يمكن فصلهما بحال.
- اختبار غازات الدم الشرياني (ABG) بشكل صريح للدم المأخوذ من الشريان. يقيم تحليل ABG ضغط المريض الجزئي للأكسجين (PaO2) وثاني أكسيد الكربون (PaCO2). يوفر PaO2 معلومات عن حالة الأوكسجين ، ويقدم PaCO2 معلومات عن حالة التهوية (فشل تنفسي مزمن أو حاد) يتأثر PaCO2 بفرط التنفس (التنفس السريع أو العميق) ، ونقص التهوية (التنفس البطيء أو الضحل)، وحالة القاعدة الحمضية. على الرغم من أنه يمكن تقييم الأكسجين والتهوية بطريقة غير جراحية عن طريق قياس التأكسج النبضي ومراقبة ثاني أكسيد الكربون في نهاية المد ، على التوالي ، فإن تحليل ABG هو المعيار.
- فمن المثير ألا ينزعج الطبيب أو الممرضة اذا وجد صعوبة في تفسير بعض النتائج لغازات الدم.
Three and One Method (Yasser’s Method) to Overcome Streptokinase-Induced Hypo...YasserMohammedHassan1
Aim of the study: The study aimed to clarify how to overcome streptokinase-induced hypotension during acute myocardial infarction intravenous infusion? Background: Streptokinase is the cheapest approved thrombolytic agent. Streptokinase is commonly associated with hypotension. The delay in giving a thrombolytic agent for acute myocardial infarction may be hazardous. Method of study and patients: My study was an observational-retrospective twenty-case report series. The study was conducted in Fraskour Central Hospital and Kafr El-Bateekh Central Hospital. The author reported twenty cases of confirmed acute myocardial infarction with indications for thrombolytic over about 34 months, starting on October 5, 2018, ended on July 25, 2021. Testing for the probability of hypotension during infusion of streptokinase was done for all cases. Three and One Method (Yasser’s Method) was only applied in the cases of hypotension during streptokinase intravenous infusion. Results: The mean age in the current study is; 60.6 with male sex predominance (85%). Acute inferior myocardial infarction is the most common (55%) infarction. Pre-testing for the probability of hypotension during infusion of streptokinase was only applied in (50%) with equal positive probability and negative probability test was (50%). Yasser’s Methods was applied in (75%) in response in (100%). Conclusions: Three and One Method (Yasser’s Method) is an innovative clinical and therapeutic method in cardiovascular science. The method is used in cases of acute myocardial infarction. It is indicated in the cases of hypotension during the intravenous infusion of streptokinase. Three and One Method (Yasser’s Method) is effective, safe, and time saving for cases of acute myocardial infarction.
Three and One Method (Yasser’s Method) to Overcome Streptokinase-Induced Hypo...YasserMohammedHassan1
Aim of the study: The study aimed to clarify how to overcome streptokinase-induced hypotension during acute myocardial infarction intravenous infusion? Background: Streptokinase is the cheapest approved thrombolytic agent. Streptokinase is commonly associated with hypotension. The delay in giving a thrombolytic agent for acute myocardial infarction may be hazardous. Method of study and patients: My study was an observational-retrospective twenty-case report series. The study was conducted in Fraskour Central Hospital and Kafr El-Bateekh Central Hospital. The author reported twenty cases of confirmed acute myocardial infarction with indications for thrombolytic over about 34 months, starting on October 5, 2018, ended on July 25, 2021. Testing for the probability of hypotension during infusion of streptokinase was done for all cases. Three and One Method (Yasser’s Method) was only applied in the cases of hypotension during streptokinase intravenous infusion. Results: The mean age in the current study is; 60.6 with male sex predominance (85%). Acute inferior myocardial infarction is the most common (55%) infarction. Pre-testing for the probability of hypotension during infusion of streptokinase was only applied in (50%) with equal positive probability and negative probability test was (50%). Yasser’s Methods was applied in (75%) in response in (100%). Conclusions: Three and One Method (Yasser’s Method) is an innovative clinical and therapeutic method in cardiovascular science. The method is used in cases of acute myocardial infarction. It is indicated in the cases of hypotension during the intravenous infusion of streptokinase. Three and One Method (Yasser’s Method) is effective, safe, and time saving for cases of acute myocardial infarction.
Mimic HL MI in chest tetany with mirror ECG change, Movable phenomenon (Yasse...YasserMohammedHassan1
The reversal of mirror electrocardiographic change, reversal of ST-segment depression coronary artery spasm, and normalization of Movable phenomenon (Yasser’s phenomenon) after oxygenation. It signifies the role of oxygen in both coronary artery spasm and tetany. Mirror local electrocardiographic change is a novel described expression that may reflect the myocardial polarity in this chest tetany.
COVID-19 Pneumonia with Atrial Fibrillation, Coronary Spasm, and Wavy Triple ...YasserMohammedHassan1
Rationale: A novel COVID-19 with severe acute respiratory syndrome had arisen in Wuhan, China in December 2019 Arrhythmias are commonly recognized sequel in COVID-19 patients. Interestingly, the presentation of COVID-19 infection with a newly coronary artery spasm has a risk impact on both morbidity and mortality of COVID-19 patients. Wavy triple an electrocardiographic sign (Yasser Sign) is a new innovated diagnostic sign in hypocalcemia. Patient concerns: An elderly farmer male COVID-19 patient presented to physician outpatient clinic with bilateral pneumonia, atrial fibrillation, evidence of coronary artery spasm, and Wavy triple an electrocardiographic sign (Yasser Sign). Diagnosis: COVID-19 pneumonia with coronary artery spasm and the Wavy triple an electrocardiographic sign (Yasser Sign). Interventions: Chest CT scan, electrocardiography, oxygenation, and echocardiography. Outcomes: Gradual dramatic clinical, electrocardiographic, and radiological improvement had happened. Lessons: The reversal of electrocardiographic ST-segment depressions in a COVID-19 patient after adding oral nitroglycerine is an indicator for the presence of coronary artery spasm. It signifies the role of the anti-infective drugs, anticoagulants, antiplatelet, and steroids in COVID-19 patients with bilateral pneumonia, AF, coronary artery spasm are effective therapies. The disappearance of AF after initial therapy may a guide for a good prognosis in this case study. The evanescence of Wavy triple ECG sign as a hallmark for the existence of the Movable-weaning phenomenon of hypocalcemia is recommended for further wide-study.
Sgarbossa Criteria in Left Bundle Branch Block in a Hypertensive Emergency, a...YasserMohammedHassan1
Left bundle branch block and hypertensive emergency are very often to occur in the clinical practice. But, developing of Sgarbossa criteria in left bundle branch block throughout the course of hypertensive emergency was an extremely rare. My current case is a hypertensive emergency patient with acute chest pain and left bundle branch block. Sgarbossa criteria were initially very weak but, became highly suggestive for acute ST-segment elevation myocardial infarction with time. With strong collective data for the case, the chance for thrombolytic therapy was strictly indicated. So why was the case developed an acute ST-segment elevation myocardial infarction to received thrombolytic therapy?.
Oxygen Reversal of Coronary Artery Spasm with Modification of International S...YasserMohammedHassan1
Abstract Aim of the study: the study aims to clear the initial effect of non-baric oxygen inhalation on the coronary artery spasm. Background: Coronary artery spasm (CAS) is a cardiovascular disorder that plays an important role in the pathogenesis of stable angina, unstable angina, myocardial infarction, and sudden cardiac death. Nitrate, calcium channel blockers, and statins are known established medications in the reversal of coronary artery spasms. Oxygen safety versus adverse effects of nitrate, calcium channel blockers, and statins are comparable. Method of study and patients: My case study was an observational-retrospective seventeen case report series. The study was conducted in Fraskour Central Hospital, Kafr El-Bateekh Central Hospital, and physician outpatient. The author reported the seventeen cases of acute angina with rest chest pain over about 38-months, starting on December 15, 2018, ended on February 7, 2022. Results: The mean age is; 43.2 with the female sex predominance (64.71%). Housewife (29.41%) and students (23.53%) are the most affected occupations. The main complaint is chest pain (64.71%). The most common associated risk factors are female sex (64.71%) and stress (23.53%). Drug-induced (23.53%), hyperventilation syndrome-induced (23.53%), and CO toxicity-induced coronary artery spasm (17.65%) are common diagnoses. The dose of inhaled O2 dose that achieved the reversal of CAS varied from 5 to 12 liter. A maximal dose (12 minutes) was given for CO toxicity. The duration of inhaled O2 dose that achieved the reversal CAS varied from 15 to 80 minutes. Maximal duration (80 minutes) was given in CO toxicity. The complete response had happened in 94.12%. Conclusions: Dramatic clinical reliving and reversal response of electrocardiographic ST-segment depression after oxygen inhalation is an indication for its initial use in coronary artery spasm. Yasser's Modification or Oxygen test for the past "international standards for the diagnostic criteria of coronary vasomotor disorders" improves patient safety and decreases the hazards of nitrate and other medications.
CHARGE syndrome hallmarked with Wolff-Parkinson-White syndrome and patent duc...YasserMohammedHassan1
Abstract
Rationale: CHARGE syndrome or Hall-Hittner syndrome is a pleiotropic disorder, in which the name is derived from the abbreviation epitomizing its six clinical criteria: ocular coloboma, cardiac defects, choanal atresia, growth or developmental retardation, genital hypoplasia, and ear anomalies or deafness. Wolff-Parkinson-White syndrome is the most frequent pattern of ventricular pre-excitation. Patent ductus arteriosus is one of the most frequent congenital heart diseases due to failure of closure of the ductus arteriosus within 72 hours of birth. CHARGE syndrome, Wolff-Parkinson-White syndrome, and patent ductus arteriosus are so difficult to be present in a single entity. Patient concerns: A young female girl patient presented to the physician outpatient clinic with acute confusion status with a past repaired patent ductus arteriosus. Diagnosis: CHARGE syndrome hallmarked with Wolff-Parkinson-White syndrome and patent ductus arteriosus; 20 years post-repairing. Interventions: Plain chest x-ray, electrocardiography, oxygenation, and echocardiography. Outcomes: A dramatic clinical improvement post-oxygenation had happened. Lessons: CHARGE syndrome with Wolff-Parkinson-White syndrome and repaired patent ductus arteriosus is an extreme combination. The existence of infantile electrocardiographic Tee-Pee sign of hypocalcemia and adult low ionized calcium with CHARGE syndrome is highly suggestive of associated DiGeorge phenotype syndrome. An absence of tachycardia post- repairing of patent ductus arteriosus from 11 mo until the 20th-year-old is a good prognostic sign. The presence of an infantile T-wave alternance will strengthen both the risk of serious arrhythmia and the efficacy of patent ductus arteriosus repairing.
Sgarbossa Criteria in Left Bundle Branch Block in a Hypertensive Emergency, a...YasserMohammedHassan1
ABSTRACT
Rationale: Left bundle branch block and hypertensive emergency are very common conditions in clinical cardiovascular and emergency practice. Hypertensive emergency encompasses a spectrum of clinical presentations in which uncontrolled blood pressure leads to progressive end-organ dysfunction. Suspected acute myocardial infarction in the setting of a left bundle branch block presents a unique diagnostic and therapeutic challenge to the clinician. The diagnosis is especially difficult due to electrocardiographic changes caused by altered ventricular depolarization. However, reports on the use of Sgarbossa’s criteria in the management of hypertensive emergencies are rare. Patient concerns: A middle-aged married heavy-smoker Egyptian male worker presented to the emergency department with a hypertensive emergency patient with acute chest pain and left bundle branch block. Sgarbossa’s criteria were initially very weak and, over time, became highly suggestive of acute ST-segment elevation myocardial infarction. Interestingly, chest pain increased as Sgarbossa’s diagnostic criteria were met. Thrombolytic therapy was strongly indicated because of a higher development of Sgarbossa criteria scoring. Intervention; Electrocardiography, oxygenation, streptokinase IVI, and echocardiography Diagnosis: Developing acute ST-segment elevation myocardial infarction in the presence of
left bundle branch block post hypertensive emergency. Outcomes: The dramatic response to developing acute myocardial infarction in the left bundle branch block with hypertensive emergency to streptokinase. Lessons: The higher Sgarbossa criteria scoring in the case was the only indication for thrombolytic. Therefore, how did Sgarbossa's criteria develop during case management to indicate the need for thrombolytic therapy?
Oxygen Reversal of Coronary Artery Spasm with Modification of International S...YasserMohammedHassan1
Abstract
Aim of the study: the study aims to clear the initial effect of non-baric oxygen inhalation on the coronary artery spasm. Background: Coronary artery spasm (CAS) is a cardiovascular disorder that plays an important role in the pathogenesis of stable angina, unstable angina, myocardial infarction, and sudden cardiac death. Nitrate, calcium channel blockers, and statins are known established medications in the reversal of coronary artery spasms. Oxygen safety versus adverse effects of nitrate, calcium channel blockers, and statins are comparable. Method of study and patients: My case study was an observational-retrospective seventeen case report series. The study was conducted in Fraskour Central Hospital, Kafr El-Bateekh Central Hospital, and physician outpatient. The author reported seventeen cases of acute angina with rest chest pain over about 38 months; starting on December 15, 2018, ended on February 7, 2022. Results: The mean age is 43.2 with the female sex predominance (64.71%). Housewives (29.41%) and students (23.53%) are the most affected occupations. The main complaint is chest pain (64.71%). The most common associated risk factors are female sex (64.71%) and stress (23.53%). Drug-induced (23.53%); hyperventilation syndrome-induced (23.53%); and CO toxicity-induced coronary artery spasm (17.65%) are common diagnoses. The dose of inhaled O2 dose that achieved the reversal of CAS varied from 5 to 12 liter. A maximal dose (12 minutes) was given for CO toxicity. The duration of inhaled O2 dose that achieved the reversal CAS varied from 15 to 80 minutes. Maximal duration (80 minutes) was given in CO toxicity. The complete response had happened in 94.12%. Conclusion: Dramatic clinical reliving and reversal response of electrocardiographic ST-segment depression after oxygen inhalation is an indication of its initial use in coronary artery spasms. Yasser’s Modification or Oxygen test for the past “international standards for the diagnostic criteria of coronary vasomotor disorders” improves patient safety and decreases the hazards of nitrate and other medications.
Mimic high lateral myocardial infarction in chest tetany with mirror electroc...YasserMohammedHassan1
The reversal of mirror electrocardiographic change, reversal of ST-segment depression coronary artery spasm, and normalization of Movable phenomenon (Yasser’s phenomenon) after oxygenation. It signifies the role of oxygen in both coronary artery spasm and tetany. Mirror local electrocardiographic change is a novel described expression that may reflect the myocardial polarity in this chest tetany.
Zavras-Kounis syndrome simultaneously with reactional myoclonus post-streptok...YasserMohammedHassan1
Rationale: Drug-associated adverse effects are one of the most important entities in clinical medicine. Involuntary movements may have a dynamic serious impact on myocardial muscle. Myoclonus is well as abnormal involuntary movements with a distinct description. Myoclonus is a physical trauma and stress for coronary arteries. Physical and mechanical stress may be causing coronary artery spasm. Drug-inducing allergic angina, allergic coronary artery spasm, and allergic myocardial infarction are renowned as Zavras-Kounis syndrome. Streptokinase is a still-known effective thrombolytic in myocardial infarction. There is a correlation between COVID-19 infection and myocardial infarction. Patient concerns: A 70-year-old married, farmer, smoker, Egyptian male patient was admitted to the critical care unit with acute inferior myocardial infarction and suspected COVID-19 pneumonia. An interlacing generalized myoclonus and allergic coronary artery spasm occurred. Diagnosis: Reactional myoclonus with allergic coronary artery spasm post-streptokinase in COVID-19 inducing myocardial infarction. Interventions: Electrocardiography, oxygenation, streptokinase intravenous infusion, and echocardiography. Outcomes: Reactional generalized myoclonus with coronary artery spasm had happened during-streptokinase infusion but the dramatic response was the result. Lessons: Dramatic clinical and electrocardiographic response after using the traditional anti-allergic signifying its role and suggest the diagnosis of Zavras-Kounis syndrome. The presence of continuing generalized myoclonus movements with the disappearance of coronary artery spasm after stoppage may be directed to the myoclonus cause. Streptokinase causing generalized myoclonus movements previously unknown, so it is a new recording adverse effect finding. The presence of involuntary movements, COVID-19 pneumonia, myocardial infarction, elderly, and cigarette smoking are prognostic factors for the severity of the disease.
Café Au Lait Spot is A Marker for Pheochromocytoma in Hypertensive Crisis Wit...YasserMohammedHassan1
Café au lait Spot is a marker for pheochromocytoma in hypertensive crisis but with a wide-differential diagnosis. Labetalol may be chosen in hypertensive crisis due to pheochromocytoma.
Acute myocardial infarction associated with right bundle branch block and cha...YasserMohammedHassan1
Acute myocardial infarction may be associated right bundle branch block.
Accompanied trifascicular heart block had pre-streptokinase left anterior fascicular block
with left axis deviation and post-streptokinase left posterior fascicular block with right axis
deviation.
Wavy Triple Sign of Hypocalcemia or Yasser’s Sign-in Diabetic Ketoacidosis-Dr...YasserMohammedHassan1
The wavy triple an electrocardiographic sign (Yasser’s sign) and hypocalcemia are commonly seen in diabetic ketoacidosis. Dramatic spontaneous improvement of both wavy triple an electrocardiographic sign (Yasser’s sign) and hypocalcemia simultaneously after the management of diabetic ketoacidosis in most cases.
الأدوية الخطرة بالعناية والطوارئ-Dr. Yasser Mohammed Hassanain Elsayed.pptxYasserMohammedHassan1
• هنالك العديد من الأدوية الخطرة التي طالما نستخدمها بالمستشفيات، خاصة بأقسام الطوارىء أو الرعاية الحرجة.
• البعض منها يكون في أقسام الطوارئ، والبعض الأخر يكون في أقسام الرعاية الحرجة، وأحيانا تكون في الأقسام الداخلية للمستشفيات.
• ربما تتصدر مشكلات كبيرة عن استخدام هذه الأدوية، هذا فضلا عن الصغيرة منها، مثل:
- توقف القلب وربما الموت المفاجيء.
- الزيادة الخطرة بضربات القلب
- حدوث ذبحة صدرية
- أو حدوث جلطة دموية في القلب
- حدوث ألم شديد بالصدر
- حدوث فشل تنفسي أو إثارته.
- حدوث فشل كبدي أو إثارته.
- حدوث ضعف حاد بعضلة القلب أو إثارته.
- الى غير ذلك من صور وأشكال عديدة، من المضاعفات.
ألم الصدر التشخيص- وكيفية التعامل معه-Dr. Yasser Mohammed Hassanain Elsayed.pptxYasserMohammedHassan1
• يعتمد تشخيص وعلاج ألم الصدر على السبب.
فقد تتنوع أسباب ألم الصدر من مشكلات صغيرة، مثل:
- حرقة المعدة
- الضغط النفسي
- حالات الطوارئ الطبية الخطيرة مثل النوبة القلبية
- أو تكوُّن جلطة دموية في الرئتين (الإنصمام الرئوي).
• يأخذ ألم الصدر صورا وأشكالا عديدة، وتتراوح حدته بين الشعور بطعنات حادة وحتى الألم الخفيف. وفي بعض الأحيان، يكون ألم الصدر ساحقًا أو حارقًا. وفي حالات أخرى، ينتقل الألم صعودًا إلى الرقبة وإلى داخل الفك، ثم ينتشر للخلف أو للأسفل لتشعر به في أحد الذراعين أو في الذراعين معًا.
Explore our comprehensive data analysis project presentation on predicting product ad campaign performance. Learn how data-driven insights can optimize your marketing strategies and enhance campaign effectiveness. Perfect for professionals and students looking to understand the power of data analysis in advertising. for more details visit: https://bostoninstituteofanalytics.org/data-science-and-artificial-intelligence/
Levelwise PageRank with Loop-Based Dead End Handling Strategy : SHORT REPORT ...Subhajit Sahu
Abstract — Levelwise PageRank is an alternative method of PageRank computation which decomposes the input graph into a directed acyclic block-graph of strongly connected components, and processes them in topological order, one level at a time. This enables calculation for ranks in a distributed fashion without per-iteration communication, unlike the standard method where all vertices are processed in each iteration. It however comes with a precondition of the absence of dead ends in the input graph. Here, the native non-distributed performance of Levelwise PageRank was compared against Monolithic PageRank on a CPU as well as a GPU. To ensure a fair comparison, Monolithic PageRank was also performed on a graph where vertices were split by components. Results indicate that Levelwise PageRank is about as fast as Monolithic PageRank on the CPU, but quite a bit slower on the GPU. Slowdown on the GPU is likely caused by a large submission of small workloads, and expected to be non-issue when the computation is performed on massive graphs.
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Empowering the Data Analytics Ecosystem: A Laser Focus on Value
The data analytics ecosystem thrives when every component functions at its peak, unlocking the true potential of data. Here's a laser focus on key areas for an empowered ecosystem:
1. Democratize Access, Not Data:
Granular Access Controls: Provide users with self-service tools tailored to their specific needs, preventing data overload and misuse.
Data Catalogs: Implement robust data catalogs for easy discovery and understanding of available data sources.
2. Foster Collaboration with Clear Roles:
Data Mesh Architecture: Break down data silos by creating a distributed data ownership model with clear ownership and responsibilities.
Collaborative Workspaces: Utilize interactive platforms where data scientists, analysts, and domain experts can work seamlessly together.
3. Leverage Advanced Analytics Strategically:
AI-powered Automation: Automate repetitive tasks like data cleaning and feature engineering, freeing up data talent for higher-level analysis.
Right-Tool Selection: Strategically choose the most effective advanced analytics techniques (e.g., AI, ML) based on specific business problems.
4. Prioritize Data Quality with Automation:
Automated Data Validation: Implement automated data quality checks to identify and rectify errors at the source, minimizing downstream issues.
Data Lineage Tracking: Track the flow of data throughout the ecosystem, ensuring transparency and facilitating root cause analysis for errors.
5. Cultivate a Data-Driven Mindset:
Metrics-Driven Performance Management: Align KPIs and performance metrics with data-driven insights to ensure actionable decision making.
Data Storytelling Workshops: Equip stakeholders with the skills to translate complex data findings into compelling narratives that drive action.
Benefits of a Precise Ecosystem:
Sharpened Focus: Precise access and clear roles ensure everyone works with the most relevant data, maximizing efficiency.
Actionable Insights: Strategic analytics and automated quality checks lead to more reliable and actionable data insights.
Continuous Improvement: Data-driven performance management fosters a culture of learning and continuous improvement.
Sustainable Growth: Empowered by data, organizations can make informed decisions to drive sustainable growth and innovation.
By focusing on these precise actions, organizations can create an empowered data analytics ecosystem that delivers real value by driving data-driven decisions and maximizing the return on their data investment.
Chatty Kathy - UNC Bootcamp Final Project Presentation - Final Version - 5.23...John Andrews
SlideShare Description for "Chatty Kathy - UNC Bootcamp Final Project Presentation"
Title: Chatty Kathy: Enhancing Physical Activity Among Older Adults
Description:
Discover how Chatty Kathy, an innovative project developed at the UNC Bootcamp, aims to tackle the challenge of low physical activity among older adults. Our AI-driven solution uses peer interaction to boost and sustain exercise levels, significantly improving health outcomes. This presentation covers our problem statement, the rationale behind Chatty Kathy, synthetic data and persona creation, model performance metrics, a visual demonstration of the project, and potential future developments. Join us for an insightful Q&A session to explore the potential of this groundbreaking project.
Project Team: Jay Requarth, Jana Avery, John Andrews, Dr. Dick Davis II, Nee Buntoum, Nam Yeongjin & Mat Nicholas
Opendatabay - Open Data Marketplace.pptxOpendatabay
Opendatabay.com unlocks the power of data for everyone. Open Data Marketplace fosters a collaborative hub for data enthusiasts to explore, share, and contribute to a vast collection of datasets.
First ever open hub for data enthusiasts to collaborate and innovate. A platform to explore, share, and contribute to a vast collection of datasets. Through robust quality control and innovative technologies like blockchain verification, opendatabay ensures the authenticity and reliability of datasets, empowering users to make data-driven decisions with confidence. Leverage cutting-edge AI technologies to enhance the data exploration, analysis, and discovery experience.
From intelligent search and recommendations to automated data productisation and quotation, Opendatabay AI-driven features streamline the data workflow. Finding the data you need shouldn't be a complex. Opendatabay simplifies the data acquisition process with an intuitive interface and robust search tools. Effortlessly explore, discover, and access the data you need, allowing you to focus on extracting valuable insights. Opendatabay breaks new ground with a dedicated, AI-generated, synthetic datasets.
Leverage these privacy-preserving datasets for training and testing AI models without compromising sensitive information. Opendatabay prioritizes transparency by providing detailed metadata, provenance information, and usage guidelines for each dataset, ensuring users have a comprehensive understanding of the data they're working with. By leveraging a powerful combination of distributed ledger technology and rigorous third-party audits Opendatabay ensures the authenticity and reliability of every dataset. Security is at the core of Opendatabay. Marketplace implements stringent security measures, including encryption, access controls, and regular vulnerability assessments, to safeguard your data and protect your privacy.
8. Classify each of the following studies as:
A. Experimental
B. Observational cohort
C. Observational case-control
D. Observational cross-sectional
E. Not an analytical or epidemiologic study
1. Representative sample of residents were telephoned and asked how much they
exercise each week and whether they currently have (have ever been
diagnosed with) heart disease.
2. Occurrence of cancer was identified between April 1991 and July 2002 for
50,000 troops who served in the first Gulf War (ended April 1991) and 50,000
troops who served elsewhere during the same period.
3. Persons diagnosed with new-onset Lyme disease were asked how often they
walk through woods, use insect
9. repellant, wear short sleeves and pants, etc. Twice as many patients
without Lyme disease from the same physician’s practice were asked
the same questions, and the responses in the two groups were
compared.
4.Subjects were children enrolled in a health maintenance organization.
At 2 months, each child was randomly given one of two types of a
new vaccine against rotavirus infection. Parents were called by a
nurse two weeks later and asked whether the children had experienced
any of a list of side-effects.
12. • Study design refers to the methods and methodologies used in research to gather the data
needed to explore a specific question.
• Observational study A study design in which the investigators observe and record events
taking place in the study. The subjects are exposed under more natural conditions
• Descriptive study; An observational study that simply describes the distribution of a
characteristic.
• Analytical study; An observational study that describes associations and analyses them for
possible cause and effect.
• Experimental study; the investigator determines through a controlled process the exposure
for each individual (clinical trial) or community (community trial), and then tracks the
individuals or communities over time to detect the effects of the exposure.
• Cohort study; The term used in clinical and epidemiological research to describe a
longitudinal prospective observational study.
In an observational cohort study, subjects are enrolled or grouped on the basis of their
exposure, then are followed to document occurrence of disease. Differences will be in disease
rates between the exposed and
13. unexposed groups. A cohort study is similar in concept to the experimental study. Note that
this differs from an experimental study because, in a cohort study, the investigator observes
rather than determines the participants’ exposure status. After a period of time, the
investigator compares the disease rate in the exposed group with the disease rate in the
unexposed group.
• Longitudinal study; An observational study design in which measurements are made over a
period of time.
• Longitudinal prospective study; An observational study design in which the investigators
follow subjects for future events.
• Case–control study; A type of observational analytical longitudinal retrospective study in
which investigators start by enrolling a group of people with disease (at CDC such persons are
called case-patients rather than cases, because case refers to occurrence of disease, not a
person). As a comparison group, the investigator then enrolls a group of people without disease
(controls). Investigators then compare previous exposures between the two groups.
14. • Crossover study; A special design of controlled trials in which half of the participants are
randomly assigned to start with the placebo and then switch to active treatment, while the
other half does the opposite.
• Cross-sectional study; An observationaldescriptive study design, not causal or relational,
in which, a sample of persons from a population is enrolled and their exposures and health
outcomes are measured simultaneously. The cross-sectional study tends to assess the presence
(prevalence) of the health outcome at that point of time without regard to duration.
• The cross-sectional study is weaker than either a cohort or a case-control study because a
cross-sectional study usually cannot disentangle risk factors for occurrence of disease
(incidence) from risk factors for survival with the disease. On the other hand, a cross-sectional
study is a perfectly fine tool for descriptive epidemiology purposes. Cross-sectional studies are
used routinely to document the prevalence.
• Retrospective study; An observational study design in which the investigators study present
and past events.
15. • Meta-analysis; A methodology to critically review research studies and statistically
combine their data to help answer questions that are beyond the power of single papers.
• Questionnaire; A means of collecting data from people where they provide written
responses to a set of questions, either in their own words (open-ended questions), or by
selecting from among pre-defined answers (closed response questions).
• Pilot study; A preliminary study to test the feasibility of the protocol, before implementing the
study proper. It may also be called “pre-test”.
• Phase I clinical trials; First trials of a new active ingredient or new formulation in humans,
often carried out in healthy volunteers.
• Phase II clinical trials; Trials performed in a limited number of subjects and often of a
comparative (e.g. placebo-controlled) design, to demonstrate therapeutic activity and to
assess the short-term safety of the active ingredient in patients suffering from a disease or
condition for which the active ingredient is intended.
• Phase III clinical trials; Trials including larger (and possibly varied) patient groups, with the
purpose of determining the short-and long-term
16. safety/efficacy balance of formulation(s) of the active ingredient, and of assessing its overall
and relative therapeutic value.
• Phase IV clinical trials; Studies performed after marketing of the pharmaceutical product
to discover rare and remote side-effects.
• Randomized controlled trials; Intervention studies characterized by the prospective
assignment of subjects, through a random method, into an experimental group and a control
group.
Odds ratio; Term used in case-control studies as a measure of the odds of having the risk
factor among people with the disease divided by the odds of having the risk factor among
people without the disease.
• Hypothesis; The research hypothesis is a tentative statement that can be tested by a scientific
research design.
• The key feature of analytic epidemiology is a comparison group.
• Assignment; The process in an experiment where the researcher allocates subjects to two or
more groups, trying to achieve having groups as identical as possible to allow a valid comparison
of the results. Matching and
17. random assignment are the two most common methods.
• Attributable risk; An estimate to quantify the contribution which a particular risk factor
makes in producing the disease within a population.
• Audit of a trial; A systematic examination, carried out independently of those directly
involved in the clinical trial.
• Blinding; A randomized controlled trial may be blinded if participants in the trial are likely to
change their behavior in a systematic way that may influence the outcome of the study when
they are aware of which intervention they receive. The term “masking” is often used instead of
“blinding”.
• Coding; A method of analysis of qualitative data obtained for example in interviews, where
categories are labelled to facilitate computer analysis and examination of relationships.
• Cost–benefit analysis; A type of economic study design in which both costs and benefits of
interventions are expressed in monetary units, allowing direct comparison of competing
interventions.
18. • Cost–effectiveness analysis; A type of economic study design in which the net monetary costs
of a health care intervention per unit measure of clinical outcome or effectiveness allows direct
comparison of competing interventions.
• Validity; The extent to which a test measures what it is intended to measure.
• External validity; The extent to which the results of the study sample may be generalized to
the population from which the sample was withdrawn; also called generalizability.
• Internal validity; The degree to which the investigator’s conclusions correctly describe what
actually happened in the study. It means that within the confines of the study, results appear to be
accurate, the methods and analysis used stand up to scrutiny, and the interpretation of the
investigators appears supported.
• Matching; A sampling method to ensure that the two groups to be compared have similar
characteristics. In an intervention study, pairs of similar “matched” subjects are formed and then
one member of the pair is randomly assigned to one group and the other member to the other
group.
19. • P value; The probability that a difference or an association as large as the one observed could have occurred by
chance alone.
• Type I error; The error committed when, on the basis of a statistical test applied to the sample
of data, a conclusion is made that there is evidence of an association between variables or
difference between groups in the population, when in fact there is no difference or association.
The probability of type I error is represented by the symbol alpha (α). Another name for alpha is
the level of statistical significance.
• Type II error; A “miss”, when, on the basis of a statistical test applied to the sample of data,
a conclusion is made that there is no evidence of an association between variables or difference
between groups in the population, when in fact there is a difference or association. The probability of type I error is
represented by the symbol beta (β).
• Population; An entire set of persons, animals, objects or events which the researcher intends to
study.
• Sample; A subset selected for the study from the larger population.
• Proposal; A document written for the purpose of obtaining funding for a research project.
• Protocol; The detailed written plan of the study. Any research study should have a protocol.
20. • Qualitative methods; A research approach that emphasizes the non-numerical data and
interpretive analysis.
• Quantitative methods; A research approach that emphasizes the collection of numerical data
or data than can be quantified, and statistical analysis.
• Risk factor; A factor that is believed to increase the probability of a certain outcome or illness.
• Demographic factor; such as age, race, or sex.
• Constitutional factor; such as blood group or immune status.
• Behavior; or act such as smoking or having eaten salsa.
• Circumstance; such as living near a toxic waste site.
• Sampling error; The discrepancy between the values obtained from the relatively small
sample and the larger population from which the sample was drawn.
• Selection bias; A systematic difference between people who are selected for a study and those
who are not selected.
• Sensitivity; of a diagnostic test is the proportion of people who test as positive to a
21. disease who really have the disease, i.e. they are true positive.
• Specificity; The proportion of people who test negatively for a disease.
• True negative; A diagnostic test correctly indicating that a person does not have the
disease.
• True positive; A diagnostic test correctly indicating that a person has the disease.
• Standard deviation; A measure of the dispersion or variability of a group of scores.
• Standard error; A statistical measure of the probability that the finding in the sample will
reflect the finding in the population from which the sample was drawn.
• Statistical significance; A statistic indicating that the result obtained is probably not due to
chance but is real. A statistically significant result does not necessarily mean that it is important
or interesting.
23. • Some research questions are best approached by statistical analysis of data. This is
quantitative research. Others are better answered by looking for patterns, features or themes
in the data. This is qualitative research.
• Whereas quantitative research aims to develop objective theories by generating quantifiable
numerical data, qualitative research aims to understand meaning. This might be the
meanings that people attribute to their work, their behaviors or beliefs, or their attitudes or
perceptions.
• Qualitative research is often based on methods of observation and enquiry; qualitative
research “explores the meaning of human experiences and creates the possibilities of change
through raised awareness and purposeful action”.
• Qualitative research focuses on life experiences; they are more about the “why” and “how”
rather than the “how many”, or “how often”.
24. • Qualitative study designs might be chosen for any number of reasons. In health, you might
be interested in finding out how nurses feel or experience care in the ICU; or you might want
to find out how people engaged in heavy substance use found the experience of connecting
with a support agency.
• Qualitative study designs are beneficial for certain types of research questions such as
those looking to provide unique insights into specific contexts or social situations.
• However, they are not as strong when wanting to find direct cause and effects links or where
a statistically significant result is required.
25. 5 W and One H questions
• This section attempts to answer the 5 W and One H questions—Who, What, When,
Where, Why and How.
• It should include detailed information on the interventions to be made, procedures to be
used, measurements to be taken, observations to be made, laboratory investigations to be
done etc.
29. • In a case report is a detailed report of the diagnosis, treatment, response to treatment,
and follow-up after treatment of an individual patient.
• A case study/case report can be used in the following instances:
• Where there is atypical or abnormal behaviour or development
• An unexplained outcome to treatment
• An emerging disease or condition
34. • Case reports and case series usually contain demographic information about the patient(s),
for example, age, gender, ethnic origin.
• When information on more than three patients is included, the case series is considered to
be a systematic investigation designed to contribute to generalizable knowledge (i.e.,
research), and therefore submission is required to the IRB (Consent form).
35. • Advantages
• Can be published quickly
• Provides very detailed information
• Allows detailed investigation into situations which would be unethical or impractical
to perform using another study design
• Disadvantages
• May include researcher bias
• Difficult to replicate
• Can't always be generalized to the broader population
• The concept of “case series” is not well defined in the literature and does not reflect a
specific research design.
• A case series should have more than four patients while four patients or less should be reported
individually as case reports.
36. • Critical appraisal tools
• JBI Critical Appraisal Checklist for Case Series
• JBI Critical Appraisal Checklist for Case Reports
38. • Analytical studies are of 2 types: observational and experimental.
• Observational studies are studies that we conduct without any intervention or
experiment. In those studies, we purely observe the outcomes.
• On the other hand, in experimental studies, we conduct experiments and
interventions.
43. •The stages of a Cross-Sectional study
• Repeated Cross-Sectional Data Analysis
44. • This design is transverse where we take a specific sample at a specific time
without any follow-up
• It allows us to calculate the frequency of disease (prevalence) or the frequency of
a risk factor
• This design is easy to conduct
• For example 1; if we want to know the prevalence of migraine in a population,
we can conduct a cross-sectional study whereby we take a sample from the
population and calculate the number of patients with migraine headaches.
Example 2; researchers studying developmental psychology might select
groups of people who are different ages but investigate them at one point in
time. By doing this, any differences between the ages groups can presumably be
attributed to age differences rather than something that happened over time.
45. • Which clinical questions does a Cross-Sectional study best answer?
• Cross-sectional study designs are useful when:
• Answering questions about the incidence or prevalence of a condition, belief
or situation.
• Establishing what the norm is for a specific demographic at a specific time.
For example: what is the most common or normal age for students
completing secondary education in Victoria?
• Justifying further research on a topic. Cross-sectional studies can infer a
relationship or correlation but are not always sufficient to determine a direct
cause. As a result, these studies often pave the way for other investigations.
46. Table -clinical questions does a Cross-Sectional study
Question Type Study Example
Frequency
How common is the outcome (disease, risk factor,
etc.)?
This cross-sectional study looks at how many
Australian people meet DSM-IV and ICD-10
diagnostic criteria for the major mental health
disorders.
Aetiology
What risk factors are associated with these
outcomes?
This cross-sectional study identifies the
characteristics of women calling the perinatal
anxiety & depression Australia (PANDA) national
helpline.
Diagnosis
Does the new test perform as well as the ‘gold
standard’?
This cross-sectional study investigates the accuracy
of a Client Satisfaction Questionnaire in relation to
client satisfaction in mental health service support.
47. • What are the advantages and disadvantages to consider when using a Cross-Sectional study design?
Advantages
• An efficient and fast study design option.
• Cross-sectional studies may still use some experimental approaches such as physically
observing participants.
• Using a cross-sectional design, multiple variables can be investigated at the one time. For
example, cross-sectional studies can collect data on a range of attributes in the one instance; the
gender, age, health conditions, access to services, etc.
• Cross-sectional studies are often useful when looking for an ethical approach to investigate
harmful situations that would otherwise be unethical if inflicted on a participant.
• Cross-sectional studies can identify potential correlations, associations and relationships
between variables.
Disadvantages
• It cannot define direct causation.
• Rare diseases and conditions can be hard to investigated
https://deakin.libguides.com/quantitative-study-designs/cross-sectional
48. Key characteristics of a cross-sectional study
The study takes place at a single point in time
It does not involve manipulating variables
It allows researchers to look at numerous characteristics at once (age,
income, gender, etc.)
It's often used to look at the prevailing characteristics in a given
population
It can provide information about what is happening in a current
population
49. • What does a strong Cross-Sectional study look like?
• Appropriate recruitment of participants. The sample of
participants must be an accurate representation of the
population being measured.
• Sample size. As is the case for most study types a larger
sample size gives greater power and is more ideal for a
strong study design.
• A suitable number of variables. Cross-sectional studies
ideally measure at least three variables.
50. • What are the pitfalls to look for?
• Cross-sectional studies are at risk of participation
bias, or low response rates from participants. If a
large number of surveys are sent out and only a quarter
are completed and returned then this becomes an issue as
those who responded may not be a true representation of
the overall population.
51. • Critical appraisal tools
Axis Appraisal Tool for Cross Sectional Studies
Critical Appraisal Tool for Cross- Sectional Studies (CAT-CSS)
Critical Appraisal of a Cross-Sectional Study on Environmental Health
Critical appraisal tool for cross-sectional studies using biomarker data
(BIOCROSS)
CEBM Critical Appraisal of a Cross-Sectional Study (Survey)
JBI Critical Appraisal checklist for analytical cross-sectional studies
Specialist Unit for Review Evidence (SURE) 2018. Questions to assist with the
critical appraisal of cross sectional studies
STROBE Checklist for cross-sectional studies
53. History
• These findings (and more) have come out of a large cohort
study started in 1972 by researchers at the University of Otago
in New Zealand. This study is known as The Dunedin Study
and it has followed the lives of 1037 babies born between 1
April 1972 and 31 March 1973 since their birth. The study is
now in its fifth decade and has produced over 1200 publications
and reports, many of which have helped inform policy makers
in New Zealand and overseas.
54. • Characteristics
• Cohort Studies are a type of observational longitudinal study.
• We conduct this study by comparing two samples from the
population: one sample with a risk factor while the other lacks this
risk factor
• It shows us the risk of developing the disease in individuals with the
risk factor compared to those without the risk factor (RR = relative
risk)
• We may approach this study by 2 longitudinal designs:
• Prospective: we follow the individuals in the future to know who
will develop the disease
• Retrospective: we look to the past to know who developed the
55. disease (e.g. using medical records)
• This design is the strongest among the observational studies
• For example – to find out the relative risk of developing chronic
obstructive pulmonary disease (COPD) among smokers, we take a
sample including smokers and non-smokers. Then, we calculate the
number of individuals with COPD among both.
56. • How Cohort Studies are carried out, A. Prospective;
https://deakin.libguides.com/quantitative-study-designs/cohortstudies
57. • How Cohort Studies are carried out-B. Retrospective;
https://deakin.libguides.com/quantitative-study-designs/cohortstudies
59. • What is a Cohort Study design?
• Cohort studies are longitudinal, observational studies, which
investigate predictive risk factors and health outcomes.
• They differ from clinical trials, in that no intervention, treatment,
or exposure is administered to the participants. The factors of interest
to researchers already exist in the study group under investigation.
• Study participants are observed over a period of time. The
incidence of disease in the exposed group is compared with the
incidence of disease in the unexposed group.
• Because of the observational nature of cohort studies they can only
find correlation between a risk factor and disease rather than the
cause.
60. • Cohort studies are useful if:
• There is a persuasive hypothesis linking an exposure to an
outcome.
• The time between exposure and outcome is not too long
(adding to the study costs and increasing the risk of participant
attrition).
• The outcome is not too rare.
61. • The stages of a Cohort Study
• A cohort study starts with the selection of a group of participants
(known as a ‘cohort’) sourced from the same population, who must
be free of the outcome under investigation but have the potential
to develop that outcome.
• The participants must be identical, having common characteristics
except for their exposure status.
• The participants are divided into two groups – the first group is
the ‘exposure’ group, the second group is free of the exposure.
62. • Types of Cohort Studies
Prospective
• The two groups of cohorts (exposed and un-exposed) are followed prospectively over time to
track the development of new disease.
• Example: In a prospective cohort study researchers compared four different groups of women
(two at-high risk groups, two low-risk groups) to investigate which groups were more likely to
develop PTSD symptoms after a birthing event.
Retrospective
• Cohorts are defined from a previous point in time, and are not followed up in the future.
• Information or data is collected from past clinical records and the outcome of interest is
investigated.
• Useful for tracking the progress of a disease with a long latency period.
• Example: used previously data collected to investigate whether there was an association between
birth experience and subsequent maternal care-giving attitudes and behaviour over a 12-month
period
https://deakin.libguides.com/quantitative-study-designs/cohortstudies
63. • Which clinical questions does this study design best answer?
Question Type Study Example
Risks What risk factors predict disease?
This cohort study looks at dietary and lifestyle risk factors and
investigates how they might contribute to hypertension in
women.
Aetiology What factors cause these outcomes?
This cohort study looks at factors in early life that may predict
the occurrence of adolescent suicide.
Prognosis
What happens with this disease over
time?
This cohort study examines the instances of recovery from a
first-time episode of psychosis.
Diagnosis
If the test is positive, what happens
to the patient?
This cohort study examines recently released adults from prison
who have been diagnosed with both a mental illness and
substance use disorder and investigates what happens to them
following their diagnosis.
https://deakin.libguides.com/quantitative-study-designs/cohortstudies
64. • What are the advantages and disadvantages to consider when using a
Cohort Study?
Advantages
• The only observational study design that directly investigates risk of
disease and the factors contributing to it.
• Ethically safe.
• Multiple outcomes can be measured.
• They are good for rare types of exposures, e.g. an exposure to a chemical
spill in a factory.
Disadvantages
• Not appropriate for rare diseases or those that take a long time to develop
e.g. mesothelioma.
• Not appropriate for studying multiple exposures.
• Can be costly and time consuming.
https://deakin.libguides.com/quantitative-study-designs/cohortstudies
65. • What does a strong Cohort Study look like?
• The aim of the study is clearly stated.
• It is clear how the sample population was sourced, including inclusion and
exclusion criteria. The sample group accurately reflects the population.
• Loss of participants to follow up.
• The control group is clearly described to minimize bias and confounding.
• It is clearly stated whether the study was blinded or not.
• The methodology was rigorously adhered to.
valid measurements and appropriate statistical tests.
• The conclusions are logically drawn from the results.
• Includes a clear description of the data, including accessibility and
availability.
66. • What are the pitfalls to look for?
• Confounding factors within the sample groups may be difficult to
identify.
• Participants may move between exposure/non-exposure
categories.
• Study may influence behavior of participants.
• Too many participants may drop out.
67. • Critical appraisal tools
• Critical appraisal checklist for cohort studies (JBI)
• CASP appraisal checklist for cohort studies
70. • We conduct this study by comparing 2 groups: one group with the disease (cases) and
another group without the disease (controls)
• This design is always retrospective
• We aim to find out the odds of having a risk factor or an exposure if an individual has a
specific disease (Odds ratio)
• Relatively easy to conduct
• For example – we want to study the odds of being a smoker among hypertensive patients
compared to normotensive ones.
• There are two groups of people: one has a health issue (Case group), and this group is
“matched” to a Control group without the health issue based on characteristics like age,
gender, occupation.
• We can look back in the patient’s histories to look for exposure to risk factors to the Case group,
but not the Control group.
• There is a link between carcinoma of the lung and smoking tobacco. These studies estimate the
odds between the exposure and the health outcome, however they cannot prove causality.
71. • Referred to as retrospective or case-referent studies.
• Stages of a Case-Control study
• This diagram represents taking both the case (disease) and the control (no disease) groups
and looking back at their histories to determine their exposure to possible contributing
factors.
• For Accessibility: A case control study is likely to show that most, but not all exposed
people end up with the health issue, and some unexposed people may also develop the health
issue).
72. • Which Clinical Questions does Case-Control best answer?
• The best used for Prognosis questions.
• For example: Do anticholinergic drugs increase the risk of dementia in later life?
73. • What are the advantages and disadvantages to consider when using Case-
Control?
Advantages • Find the source of an existing illness or epidemic.
• Cheap and quick.
• Few ethics issues as the patient already has the health condition
• Looks at multiple risk factors.
Disadvantages • Patient recall about their history can be inaccurate (recall bias).
• Certain risk factors may focus and ignore other exposures.
• No randomization is possible, lowering internal validity.
• Finding a Control group that matches the Case group appropriately can be difficult.
• Not prove a clear causal relationship between risk factors and illness, only calculates the odds.
Opportunities • Useful for rare conditions.
• Identify point of outbreak.
• Can look at many exposure factors of the patient’s environment.
Confounding* • If the health issue causes multiple common exposures…which is more likely. For example, having a chronic illness. spend more time
in hospital environments, have a lower immune system, and suffer high levels of stress – so any of these could potentially be the cause
of that chronic illness. The study must make an attempt to eliminate some of these exposures as causes if possible.
• If the Control group is overmatched.
• If the Control group is under-matched.
For example, if you could not find female Controls to match female Cases.
https://deakin.libguides.com/quantitative-study-designs/casecontrol
74. • What does a strong Case-Control study look like?
• A strong study will have:
• Well-matched controls.
• Detailed medical histories are available, reducing unreliable recall.
75. • What are the pitfalls to look for?
• Poorly matched or over-matched controls. Poorly-matched means that not
enough factors are similar between the Case and Control. e.g. age, gender,
geography. Over-matched conversely means that so many things match (age,
occupation, geography, health habits) that in all likelihood the
• Selection bias: Selection of Controls is biased. E.g. All Controls are in the
hospital, so they’re likely already sick.
76. • Critical appraisal tools
• CASP - Case Control Checklist
• JBI – Critical appraisal checklist for case control studies
• CEBMA – Centre for Evidence Based Management – Critical
appraisal questions (focus on leadership and management)
• STROBE - Observational Studies checklists includes Case control
• SIGN - Case-Control Studies Checklist
• NCCEH - Critical Appraisal of a Case Control Study for
environmental health
78. • Also known as interventional studies
• Can involve animals and humans
• Pre-clinical trials involve animals
• Clinical trials are experimental studies involving humans
• In clinical trials, we study the effect of an intervention compared to another
intervention or placebo.
• An example, I have listed the four phases of a drug trial:
• I: We aim to assess the safety of the drug (is it safe ?)
• II: We aim to assess the efficacy of the drug (does it work ?)
• III: We want to know if this drug is better than the old treatment (is it
better ?)
• IV: We follow-up to detect long-term side effects (can it stay in the market ?)
79. • In 1747, James Lind, a ship’s surgeon, tested his theory for preventing the
effects of scurvy by giving 12 sailors different dietary acids. He subsequently
found that only sailors who consumed citric acid in the form of oranges and
lemons improved. This trial looked at a sample cohort (12 sailors) from a broader
population (all the sailors) and tested whether exposing part of that cohort to an
intervention of interest (citric acid), and the other part of that cohort to a different
intervention (other dietary acids), resulted in different outcomes (improved
symptoms) for the two parts of the sample cohort.
81. Forms of interventions
• In randomized controlled trials, one group of participants receives the control,
while the other receives the tested drug/intervention. Those studies are the best
way to evaluate the efficacy of a treatment.
• Interventions should be described in detail, including a description of the
drug/device/vaccine that is being tested. Interventions could also be in the realm
of social sciences for example providing training or information to groups of
individuals.
• Procedures could be biomedical (collection of blood or sputum samples to
develop a diagnostic test), or in the realm of social sciences (doing a
questionnaire survey, carrying out a focus group discussion as part of formative
research, observation of the participant's environment, etc.).
82. • Standardized and/or documented procedures/techniques should be
described and bibliographic references, if not provided earlier should be
provided.
• Instruments which are to be used to collect information (questionnaires, Focus
group discussion (FGD) guides, observation recording form, case report forms
etc.) must also be provided.
• In the case of a randomized controlled trial additional information on the
process of randomization and blinding, description of stopping rules for
individuals, for part of the study or entire study, the procedures and conditions
for breaking the codes etc. should also be described.
• A graphic outline of the study design and procedures using a flow diagram
must be provided. This should include the timing of assessments.
83. • What is a Randomized Controlled Trial?
Lind’s experiment illustrates some principles of a randomized controlled trial, but
not all. The common important features of a randomized controlled trial include:
• Researchers pre-determine eligibility criteria for the population considered
for inclusion in the trial, resulting in a population that is reasonably similar in
important ways. From here a sample is taken; this sample are the trial
participants.
• Participants are randomly assigned to an experimental or control group.
This reduces the potential for bias and the impact of variables outside researcher
control.
• Researchers manage trial participants’ engagement with the study, including
exposure to the intervention of interest. This is a key difference to other,
observational
84. studies where researchers do not directly expose participants to
interventions.
• The experimental group is exposed to the intervention of interest
while the control group is not. Both groups are then followed in
order for a comparison to be made between their respective outcomes.
85. • The stages of a Randomised Controlled Trial
Principles Identified • Eligible population defined and sample cohorts enrolled as participants
Randomisation • Participants randomly allocated to experimental or control group
Pre-exposure
Measurement
• Feature (s) of interest measured in both groups
Exposure
• Experimental group exposed to intervention of interest
• Control group exposed to comparison intervention
Post-exposure
Measurement
• Feature (s) of interest measured in both groups
Analysis
• Feature (s) of interest in both groups are compared
• Conclusions about intervention of interest are made
https://deakin.libguides.com/quantitative-study-designs/rct
86. • Which clinical questions does this study design best answer?
• Randomized controlled trials are excellent at answering questions about the effects of an intervention on a population.
Question Type Study Example
Effectiveness
Is a proposed intervention as effective as the
established intervention?
This study looked at the effectiveness of
play-based interventions for pre-schoolers
with behavioural issues.
Side effects
Does a proposed intervention have worse side effects
than the established intervention?
This study looked at medication intended to
reduce blood loss after vaginal delivery.
Cost of treatment
Which intervention for a specific condition results in
less cost to a healthcare service?
This study compared two methods of
repairing aortic aneurysms.
Patient adherence to treatment
Which intervention are patients more likely to
positively respond to?
This study looked at whether SMS
messages improved adherence rates in
patients receiving antiretroviral therapy.
Duration of effect of treatment Which intervention provides longer-lasting benefit?
This study looked at treatments for
colorectal cancer and measured survival
rates among participants.
https://deakin.libguides.com/quantitative-study-designs/rct
87. • What are the advantages and disadvantages to consider when using a
Randomized Controlled Trial?
Advantages
• Randomisation and blinding reduce bias and impact of confounders.
Confounders are variables which impact the outcome of a study and are outside
the control of the researchers.
• Researchers have greater control over the study’s circumstances.
• Can lead to strong conclusions about a causal relationship between exposure
and feature(s) of interest.
Disadvantages
• Design, execution and evaluation can be complex, costly and lengthy.
• Recruitment of participants can be difficult for some research.
• May not be appropriate for some research due to ethical concerns.
• May not be appropriate for some research due to difficulty of blinding
participants for some interventions.
https://deakin.libguides.com/quantitative-study-designs/rct
88. • What does a strong Randomised Controlled Trial look like?
• Interest
• It is important for RCTs to begin with a clear understanding of what is being measured and
how measures will be taken, and for these to be adhered to throughout the life of the trial..
• Random allocation to groups
• In a RCT trial participants are randomly allocated to control or experimental groups. Well-
designed trials feature randomization that is as free from bias as possible. A strong report of a
RCT should also include details of the randomization method in order to be as transparent as
possible.
• Blinding of participants and administrators
• Blinding is do not know whether a participant has been allocated to the experimental or the
control group. This is done to avoid the influence of bias. “Single-blind” trials have only the
participants unaware of group allocation while “double-blind” trials have both the
participants and administrators unaware of group allocation.
• Appropriate sample characteristics and size
• Minimal bias
• It is difficult for a study to be entirely free of bias.
89. • What are the pitfalls to look for?
• Poor recruitment
• Poor randomization
• While randomization is an important strength of randomized controlled trials, some forms of
randomization are susceptible to bias.
• Participants lost to follow-up
• Intention-to-treat not adhered to in analysis
• Bias due to industry sponsorship of trial
• Many trials are conducted with the sponsorship of companies that sell the intervention being
studied in the trial. Common examples include pharmaceuticals or medical devices. Research
published in 2018 found that studies which had industry sponsorship were more likely to
report results favorable to the intervention of interest than studies not sponsored by industry.
This suggests the existence of a bias for the studies which received industry sponsorship.
90. • How should Randomized Controlled Trials be evaluated?
• Critical appraisal
• CASP (Critical Appraisal Skills Programme)
• CEBM (Centre for Evidence-Based Medicine)
• SIGN (Scottish Intercollegiate Guidelines Network)
• RoB 2 (Cochrane risk of bias tool for randomised trials)
Finally, while not technically a critical appraisal checklist, the CONSORT
guidelines for reporting randomised trials could be useful to help understand the
expectations for appropriate reporting of such a study.
91. General information
• Name and title of the investigator(s) who is (are) responsible for conducting the
research, and the address and telephone number(s) of the research site(s), including
responsibilities of each.
• Name(s) and address(es) of the clinical laboratory(ies) and other medical
and/or technical department(s) and/or institutions involved in the research.
• Name and address of the sponsor/funder.
94. • Three widely used scholarly styles: the parenthetical author–date system recommended by
1. The sequential numerical or Vancouver system;
• It is based on an American National Standards Institute (ANSI) standard
adapted by the National Library of Medicine (NLM) for databases such as
medline.
• In Vancouver style, up to six authors, the names of all the authors are written. If
there are more than six authors, then after writing the first six authors, ‘et al’ is
used.
• Each reference number is placed in parentheses or superscripted throughout
the text, tables, and legends.
• This style recommends the use of official abbreviations for titles of journals.
95. • While using Vancouver style, if an author’s name is to be used in text, it is mandatory to use
the citation number as well. For example, as Kaur (2) emphasized the high prevalence of
depression in elderly. If there is more than one author it is recommended to use term “et al”
after writing the sir name of first author.
• Format of Article; “Surname Initial(s). Title of article. Journal title/or title abbreviation.
Year; volume (issue): page(s). DOI - if available” * It is optional to omit the month and issue
number if a journal carries continous pagination. *It is also optional to use the database unique
idenfiers such as PMID for pubmed and the clinical trial registration number.
• Example; 1. Wilson S, Bond F. Political and personal readings of the earliest zone poem.
Urban Poetry. 2016;12:72–94. doi:00.0000/00000000000000.
2. Petrie KJ, Mueller JT, Schirmbeck F, Donkin L, Broadbent E, Ellis CJ et al.
96. Effect of providing information about normal test results on patients’ reassurance:
randomised controlled trial. British Medical Journal. 2007;334(7589): 352-354. Available
from: doi:10.1136/bmj.39093.464190.55.
• Format of Book; “Surname author Initial(s). In: Surname editor Initial(s), editor(s).
Book title. Place of publication: Publisher; Year. page(s).”
• Example; Kaur S, Singh M. In: Singh A, Kaur S, Kishore J. Comprehensive Textbook
of Elderly Care. New Delhi: Century Publications, 1st Edition 2014. p 239–248.
Citation; (1).
• Several studies have taken this approach to the text (1,2,5–8).
97. 2. APA STYLE;
• The APA style is a structured format for all sort of academic writings including the journal
articles, books and other commentaries devised by the American Psychological Association
(APA).
• This style is very widely used in social and behavioral sciences like psychology, sociology,
social work, nursing and education.
• While citing reference in text, where one needs to cite one work by one author, the following
format is used: “Author’s Surname (year)”.
• For example; Sharma (2014) reported that 43% of antenatal females experience intimate partner
violence.
• When the citation has three, four, or five authors, cite all authors when the reference appears
for first time; in subsequent citations, include only the surname of the first author followed by et
al. and the year.
98. • For example; Kaur, Sharma, Bakshi and Sinha (2012) reported high prevalence of
stress among nurses. (Used as first citation in text) Kaur et al. (2012) also found
• The order of the reference list is prepared by arranging all entries in alphabetical
order by the surname of first author followed by initials of the author’s given name.
The rule is to alphabetize letter by letter.
• When there are several works by the same author, they are to be arranged by year
of publication, the earliest first.
• For example, Sharma N (2010) precedes Sharma N (2014).
• One-author entries precede multiple-author entries beginning with the same
surname even if the multiple-author work was published earlier.
• For example, Kaur (2014) shall precede Kaur, Singh and Sharma (2010). This
style mandates writing names of all the authors in reference list up to seven authors.
• If there are more than seven authors, following format is used: Kaur, S.,
Sharma,
99. N., Sharma, S., Thakur, M., Agnihotri, N. Thakur M,.… Saini, S. (2015).
• Format of Article; “Author, A.A. Author, B. B., and Author, C. C. (year). Title
of article. Title of journal, xx, pp-pp. doi:xx.xxxxxxxxxx”
• Example; Ager, A. (2013). Annual Research Review: Resilience and child
well-being – public policy implications. Journal of Child Psychology and
Psychiatry, 54(4), 488–500. doi:10.1111/ jcpp.12030
• Format of Book; “Author, A.A. (Year of Publication). Title of work. Publisher
City, State: Publisher
”
.
• Examples; 1. Wilson, S., & Bond, F. (2016). Political and personal readings
of the earliest zone poem. Urban Poetry, 12, 72–94.
doi:00.0000/00000000000000
2. Kaur, S., Singh, M. (2014). Clinical Neuroscience and Critical Care
Nursing. 1st Edition. New Delhi : Jaypee Medical Publishers
Citation; (Kaur, Singh, 2016).
100. 3. Harvard style
• This is also known as Author and Date system.
• Harvard system puts the authors and the date of work being referred to at the appropriate point
in the text rather than using a number. This is called a “citation”.
• All the works cited are then listed at the end of the report/paper in an alphabetical order
according to the authors’ surname. The reader can then refer from the text to the reference.
• It is economical in terms of time. It is very flexible as entries can be added, deleted, or changed
with a minimum of disruption to the rest of the document.
• In addition, the reader can tell immediately who the author is and when the study was
published. It emphasizes the name of the author and the publication year in the text with full
bibliographic details in a reference list.
• Format of Article; “Author(s) of article’s FAMILY/SURNAME, Initials. (Publication
101. year) Title of article. Title of journal - italicised or underlined. Volume number (Part number/
month). pp. followed by the page number of the article
”
.
• Example; Kaur, S, Singh, A., Dhillon, M.S., Tewari, M.K., Sekhon, P.K. (2015). Incidence of
bedsore among the admitted patients in a tertiary care hospital. JPMER, vol 49, no. 1, pp. 26-31.
Citation; Kaur, Singh, Dhillon, Tewari, Sekhon (2015) has reported that-
• Format of Book; “FAMILY/SURNAME, Initials. (Publication year) Book title – italicized.
Series title and volume if applicable. Edition – if not the first. Place of publication: publisher
”
.
”
.
• Examples; Dempsey, P.A. and Dempsey, A.D. (2000) Using Nursing Research: Process,
Critical Evaluation, and Utilization. 5th ed. Philadelphia: Lippincott Williams and
Wilkins.
• Citation; Dempsey, Dempsey (2014) emphasized that_.
• The reference list for sequential numerical citations is arranged, not surprisingly, by the
numerical sequence of the citations.
102. References
1. Tullu MS. Writing the title and abstract for a research paper: Being concise, precise, and meticulous is the key. Saudi J Anaesth. 2019;13(Suppl
1):S12-S17. doi:10.4103/sja.SJA_685_18
2. WHO. Recommended format for a 'research protocol". https://www.who.int/groups/research-ethics-review-committee/recommended-format-
for-a-research-protocol 14 October 2020
3. Abbas H. An introduction to different types of study design. https://s4be.cochrane.org/blog/2021/04/06/an-introduction-to-different-types-of-
study-design/ April 6, 2021.
4. Deakin University. Quantitative Study Designs. https://deakin.libguides.com/quantitative-study-designs/casestudy Last Updated: Jun 4, 2021.
5. Grimes, DA, & Schulz KF. An overview of clinical research: The lay of the land. The Lancet, 2002;359(9300), 57-61
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6. Sayre JW, Toklu HZ, Ye F, Mazza J, Yale S. Case Reports, Case Series - From Clinical Practice to Evidence-Based Medicine in Graduate
Medical Education. Cureus. 2017 Aug 7;9(8):e1546. doi: 10.7759/cureus.1546. PMID: 29018643; PMCID: PMC5630458
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PMCID: PMC3598300
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8. Lander B, Balka E. Exploring How Evidence is Used in Care Through an Organizational Ethnography of Two Teaching Hospitals. Med
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10. CDC. Principles of Epidemiology in Public Health Practice, Third Edition An Introduction to Applied Epidemiology and Biostatistics.
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(