SU7.2 Priciples and steps of clinical research in Surgery.pptx

Lecture notes for UG MBBS

1. Learning Objectives At the end of this session the learner will be able to describe the “ The principles and steps of research in clinical surgery.”

2. Research in clinical surgery Research  is "creative and systematic work undertaken to increase the stock of knowledge.”

3. Basic principles of research Inductive – Collect data and try to find the mechanism -Newton. Deductive –Form a hypothesis and match with observations The clinical research plan is based directly on inductive Newtonian ideas for proceeding from observation to inference.

4. Why to do research? To advance knowledge for the good of society. To improve the health of people worldwide To find better ways to treat and prevent disease.  The high quality of medical care we enjoy today is built upon years of effort by physicians, physician-scientists, PhDs, and other medical professionals investigating the causes of and potential treatments for disease. 

5. Types of research in Surgery Basic science research(Fundamental Research) -to increase understanding of fundamental life processes Clinical research- important questions of normal function and disease using human subjects. Translational Research  takes a result from basic or fundamental science and studies its applicability in the clinical or human situation. Applied Research  seeks the specific knowledge necessary to improve the treatment of a particular disease.

6. What is clinical research? Clinical research is the branch of scientific endeavor devoted to the evaluation of patients and the analysis of associated health outcomes. These analyses serve to identify potential areas for change in physician or patient behavior or in clinical processes. The findings will be used to modify clinical practice to achieve better outcomes.

7. Clinical Research Clinical research involves interaction with - Patients Diagnostic clinical materials or data Populations

8. Clinical Research Areas • Disease mechanisms; • Translational research • Clinical knowledge, detection, diagnosis, and natural history of disease • Therapeutic interventions, including clinical trials • Prevention and health promotion • Behavioral research • Health services research • Epidemiology • Community-based and managed care-based research.

9. Evidence Based Medicine . Evidence-based medicine is the foundation on which clinical research is built and is the explicit use of scientific data in decision making for clinical care. Approach to medical practice intended to optimize decision-making by emphasizing the use of evidence from well-designed and well-conducted research. EBM evaluates the answers to research question by meta-analysis of all research studies done on the research question

10. Evidence Based Medicine . Level IA: evidence obtained from a meta-analysis of multiple, well-conducted, and well-designed randomized trials. Randomized trials provide some of the strongest clinical evidence, and if these are repeated and the results combined in a meta-analysis, then the overall results are assumed to be even stronger. Level IB: evidence obtained from a single well-conducted and well-designed randomized controlled trial. The randomized controlled study, when well-designed and well-conducted, is a gold standard for clinical medicine.

11. Evidence Based Medicine . Level IIA: evidence from at least one well-designed and executed non-randomized controlled study. When randomization does not occur, there may be more bias introduced into the study.  Level IIB: evidence from at least one well-designed case-control or cohort study.  Not all clinical questions can be effectively or ethically studied with a randomized controlled study.  Level III: evidence from at least one non-experimental study.  Typically level III evidence would include case series as well as not well-designed case-control or cohort studies.    Level IV: expert opinions from respected authorities on the subject based on their clinical experience. :

12. Evidence Based Medicine . The evidence is commonly stratified into six different levels:  Level IA: Level IB: Level IIA: Level IIB: Level III: Level IV:

13. Research Question A  research question  pinpoints exactly what you want to find out in your work. A good research question is essential to guide your research .

14. Research Question Research questions should be: Focused  on a single problem or issue Researchable  using primary and/or secondary sources. Feasible  to answer within the timeframe and practical constraints Specific  enough to answer thoroughly Complex  enough to develop the answer over the space of a paper or thesis Relevant  to your field of study and/or society more broadly

15. Research Question:Examples What is the gate to knife time of our hospital? Does eating sour increases the SSI rate? Which is better 2ml or 4ml. perkg bodyweight per percent of burn in burn resuscitation? Does postoperative antibiotics reduce SSI rate? What are the dignoses attending our opd in the year 2024? Are the members of surgical team scrubbing for 3minutes?

16. Steps Louis Pasteur established the “IMRD” format for reporting scientific information: Introduction Methods Results Discussion

17. Steps of clinical research Background and objectives Literature review T rial design Ethical approval Funding Register in registry. Recruit participants Data collection Analysis Conclusions Discussion Publish

18. Study Designs Randomized controlled trial (RCT): Observational studies Retrospective (Data Mining) Prospective Interventional studies Cohort study Case-control study Cross-sectional study Case series/case report Multicenter trials Systematic review and meta-analysis

19. Case-control Study A case-control study is a type of observational study commonly used to look at factors associated with diseases or outcomes. We compare two existing groups differing in outcome ie . subject of interest. Except for the subject of interest the participants of two groups are otherwise similar.

20. Case-control Study The case-control study starts with a group of cases, which are the individuals who have the outcome of interest.  The researcher then tries to construct a second group of individuals called the controls, who are similar to the case individuals but do  not  have the outcome of interest. 

21. Case-control Study The researcher then looks at historical factors to identify if some exposure(s) is/are found more commonly in the cases than the controls.  If the exposure is found more commonly in the cases than in the controls, the researcher can hypothesize that the exposure may be linked to the outcome of interest.. 

22. Cohort Study Cohort studies are types of observational studies in which a cohort, ie . a group of individuals sharing some characteristic, are followed up over time, and outcomes are measured at one or more time points. Cohort studies can be classified as prospective or retrospective studies, 

23. Principles of research Informed consent Safety and ethical considerations Validity and reliability Statistical significance Transparency and openness Conflict of interest Bias Validity Sampling Blinding Randomisation Study protocol Peer review Plagiarism

24. Bias An error which tends to produce results or conclusions that differ systematically from the truth.

25. Types of Bias Selection Bias Classification bias, also aka measurement or information bias Confounding bias is a spurious association made between the outcome and a factor that is not itself causally related to the outcome. Lead-time bias Publication bias

26. Validity Internal validity examines whether the study design, conduct, and analysis answer the research questions without bias. External validity examines whether the study findings can be generalized to other contexts.

27. Plagiarism Plagiarism  is the fraudulent representation of another person's language, thoughts, ideas, or expressions as one's own original work. Not citing (acknowledging) the source is also plagiarism. It is a serious ethical offense. Punishable.

28. Types of Plagiarism Direct Plagiarism. Direct plagiarism is the word-for-word transcription of a section of someone else's work, without attribution and without quotation marks. ... Self Plagiarism. ... Mosaic Plagiarism. ... Accidental Plagiarism.

29. Conflict of Interest Conflicts of interest may be defined as “circumstances that create a risk that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest”  Primary interest is research itself. Secondary interest is financial gain or career advancement of researcher.

30. Title Conventional versus Prophylactic Mesh placement technique of midline laparotomy: A comparative study. Dr. Kameshwar Assistant Professor - Dr. Pradeep Pande Associate Professor Deptt . Of Surgery

31. Abstrac t Background and Objectives The midline laparotomy is frequently used for abdominal surgeries. Main complication is incisional hernia. The objective of this study is to compare Mesh Placement Technique with conventional Mass closure technique in preventing the incisional hernia

32. Introduction Introduction: The median laparotomy is frequently used by abdominal surgeons to gain rapid and wide access to the abdominal cavity with minimal damage to nerves, vascular structures and muscles of the abdominal wall. However, incisional hernia remains the most common complication after median laparotomy, with reported incidences varying between 2-20% 1.

33. Introduction Median laparotomies and incisional hernias have been subject of investigation for a long period of time already. Although a lot is known about patient related risk factors and suture materials, technical risk factors such as suture techniques have not been investigated thoroughly 2 .

34. Materials and Methods Trial Design This trial has been designed as a prospective, double-blind, randomized controlled trial, in which Prophylactic Mesh placementTechnique will be compared with the conventionally used large bites mass closure technique for the closure of midline laparotomy.

35. Materials and Methods 100 consecutive patients reporting to the department of General Surgery of BRK Memorial Medical College in whom midline laparotomy is indicated will be included in this study. These 100 patients will be randomized into two groups of 50 each.

36. Materials and Methods Group A patients will be managed by conventional closure of the midline incision GroupB patients will be managed by Mesh placement technique. One year after surgery the patients will be examined for the complication of incisional hernia clinically and sonographically.

37. Results: Outcome parameters Primary outcome Primary outcome will be incisional hernia occurrence within one year after surgery, either clinically and/or ultrasonographically detected.

38. Results: Outcome parameters Secondary outcomes Postoperative complications Pain Quality of life Cost effectiveness

39. Conclusions: The trial will provide level 1b evidence to support the preference for either a Prophylactic Mesh placementTechnique or for the conventionally used large bites technique

40. Participants Participants: Patients undergoing midline laparotomy in BRK Memorial Medical College Jagdalpur will be included in this study .

41. Inclusion criteria: Patients undergoing midline laparotomy in BRK Memorial Medical College Jagdalpur .

42. Exclusion criteria None

43. Analysis Differences between randomized groups will be tested with appropriate statistical methods

44. Conclusion This trial is a comparative studyof Conventional versus Prophylactic Mesh placement technique of midline laparotomy closure.

45. Bibliography Muysoms FE,  Detry O,  Vierendeels T,  Huyghe M,  Miserez M,  Ruppert M,  Tollens T,  Defraigne JO,  Berrevoet

46. MCQ A research aims at (A) Verifying the existing knowledge (B) Acquiring new knowledge (C) Filling the missing links in the existing Knowledge  (D) All of the above

47. MCQ A research aims at (A) Verifying the existing knowledge (B) Acquiring new knowledge (C) Filling the missing links in the existing Knowledge  (D) All of the above

48. MCQ Reliability of a research result implies its (A) Verifiability (B) Validity (C) Uniqueness (D) Usefulness

49. MCQ Reliability of a research result implies its (A) Verifiability (B) Validity (C) Uniqueness (D) Usefulness

50. MCQ In clinical research studies, conflict of interest is a risk factor for scientific misconduct. A.True B. False

51. MCQ In clinical research studies, conflict of interest is a risk factor for scientific misconduct. A.True B. False

52. MCQ What is "blinding" and what is its purpose? A. Blinding means you begin with the null hypothesis, and base your conclusions totally on a statistical analysis of the data without any preconceived ideas. B. Blinding refers to equipoise, i.e. uncertainty regarding whether a new treatment is effective. C. Blinding means that the subjects and/or investigators do not know which treatment group the subject is in. The purpose is to prevent bias in assessing the outcome. D. Blinding occurs when the results totally disagree with previously published studies. Its purpose is to cause a re-evaluation of the data.

53. MCQ What is "blinding" and what is its purpose? A. Blinding means you begin with the null hypothesis, and base your conclusions totally on a statistical analysis of the data without any preconceived ideas. B. Blinding refers to equipoise, i.e. uncertainty regarding whether a new treatment is effective. C. Blinding means that the subjects and/or investigators do not know which treatment group the subject is in. The purpose is to prevent bias in assessing the outcome. D. Blinding occurs when the results totally disagree with previously published studies. Its purpose is to cause a re-evaluation of the data.

54. MCQ Which statement about blinding in an intervention study is NOT correct? The purpose of blinding is to reduce bias in determining the outcome. The purpose of blinding is to reduce confounding. In a double blinded study, neither the subject nor the investigators know which treatment the subject is receiving. Blinding can be accomplished by using a placebo.

55. MCQ Which statement about blinding in an intervention study is NOT correct? The purpose of blinding is to reduce bias in determining the outcome. The purpose of blinding is to reduce confounding. In a double blinded study, neither the subject nor the investigators know which treatment the subject is receiving. Blinding can be accomplished by using a placebo.

56. MCQ What are the documents mandatory to enroll a subject in a clinical research study? A. Protocol B. Case Report Form C. Informed Consent Form D. Investigator's Brochure

57. MCQ What are the documents mandatory to enroll a subject in a clinical research study? A. Protocol B. Case Report Form C. Informed Consent Form D. Investigator's Brochure

58. Lectures one drive

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