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Description : Check out this medical presentation on Pathology, which is titled "Research Design & EBM", to know about Research Design and EBM (Evidence based medicine).

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1 Research Design & EBM Ravi Kant MS, DNB, FAMS, FRCS (Edin), FRCS (Glasg), FRCS (Engl.), FRCS (Irel.), FACS, FICS, FAIS Professor of Surgery
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2 Science Intelligent Hypothesis Experiments & analysis of results prove that hypothesis is correct. Replicable universally= Most Important
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3 Evidence based medicine: what it is and what it isn't Integrating individual clinical expertise and the best external evidence BMJ 1996;312:71-72 (13 January) Editorial
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5 Evidence-based health care? = best evidence
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6 Evidence-based health care? decision-making
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8 Observational study Evaluating results of condition or treatment in a defined population
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9 Retrospective: analyzing past events
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10 Prospective: collecting data contemporaneously
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11 Case-control Series of patients with a particular disease or condition contrasted with matched control patients
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12 Cross-sectional Measurements mode on a single occasion, not looking at whole population but selecting small similar group & expanding results
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13 Longitudinal Measurements are taken over a period of time, not looking at whole population but selecting small similar group & expanding results
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14 Experimental Two or more treatments are compared. Allocation to treatment groups is under the control of the researcher
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15 Randomized Two randomly allocated treatments
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16 Prospective Randomized controlled Includes control group with no treatment = GOLD STANDARD
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17 Confidence Interval To p or not to p
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18 RR Relative Risk
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19 Hazard ratio/ Odds ratio
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20 Systemic Review reliable systematic predefined, explicit methodology minimize bias Systemic review+ Statistics= meta-analysis
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21 Systemic Review = ?
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22
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23 Levels of evidence 1= Meta-analyses of Prospective Double blind randomized controlled trials 2=Prospective Randomized Controlled study/ Meta-analyses of retrospective studies 3= Case series/ Cohort study 4= Case report/ observational 5= Expert opinion
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24 Evidence grade: I I (High): the described effect is plausible, precisely quantified and not vulnerable to bias
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25 Evidence grade: I II (Intermediate): the described effect is plausible but is not quantified precisely or may be vulnerable to bias
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26 Evidence grade : III III (Low): concerns about plausibility or vulnerability to bias severely limit the value of the effect being described and quantified
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27 Strength of recommendation Definition A A=Recommendation based on consistent and good quality patient-oriented evidence
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28 Strength of recommendation Definition B B=Recommendation based on inconsistent or limited quality patient-oriented evidence
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29 Strength of recommendation Definition C C=Recommendation based on consensus, usual practice, opinion, disease-oriented evidence or case series for studies of diagnosis, treatment, prevention, or screening.
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30 Recommendation grade: A A (Recommendation): there is robust evidence to recommend a pattern of care
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31 Recommendation grade : B B (Provisional recommendation): on balance of evidence, a pattern of care is recommended with caution
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32 Recommendation grade : C C (Consensus opinion): evidence being inadequate, a pattern of care is recommended by consensus
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33 US Government Agency for Health Care Policy and Research (AHCPR):A A: requires at least one randomized controlled trial as part of the body of evidence.
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34 US Government Agency for Health Care Policy and Research (AHCPR):B B: requires availability of well-conducted clinical studies but no randomized controlled trials in the body of evidence.
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35 US Government Agency for Health Care Policy and Research (AHCPR):C C: requires evidence from expert committee reports or opinions and/ or clinical experience of respected authorities. Indicates absence of directly applicable studies of good quality
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37 Grading of evidence Ia: Systematic review or meta-analysis of randomized controlled trials Ib: at least one randomized controlled trial IIa: at least one well-designed controlled study without randomization IIb: at least one well-designed quasi-experimental study, such as a cohort study III: well-designed non-experimental descriptive studies, such as comparative studies, correlation studies, case–control studies and case series IV: expert committee reports, opinions and/or clinical experience of respected authorities
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38 Grading of recommendations A: based on hierarchy I evidence B: based on hierarchy II evidence or extrapolated from hierarchy I evidence C: based on hierarchy III evidence or extrapolated from hierarchy I or II evidence D: directly based on hierarchy IV evidence or extrapolated from hierarchy I, II or III evidence
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40 Research can be Quantitative: A medical condition is analyzed systematically using hard, objective end point such as death or amputation.
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41 Research can be Qualitative Data come from patient narratives, and the psychosocial impact of the disease and its treatment are analyzed, for example narratives of breast cancer.
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42 Project design include: Sample size. Eliminating bias. Study protocol. Ethics.
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43 Sample size An incorrect sample size is probably the most frequent reason for research to be invalid. Never forget that more patients will need to be randomized than the final sample size to take into account patients who die, drop out or are lost to follow up.
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44 Sample size nX[r(100-r)+s(100-s)]/(r-s)2
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45 Type I error Benefit is perceived when really there is none (false positive)
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46 Type II error Benefit is missed because the study has small numbers (false negative)
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47 Eliminating bias: Single blind The observers or recorders who do not know which treatment has been used.
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48 Eliminating bias: Double blind Neither patient nor researcher is aware of which therapy has been used until after study has finished, & these are the best randomized studies.
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49 The Cochrane Collaboration Best evidence an international not-for-profit and independent organization, It produces and disseminates systematic reviews of healthcare interventions and promotes the search for evidence in the form of clinical trials and other studies of interventions. The Cochrane Collaboration was founded in 1993 and named after the British epidemiologist, Archie Cochrane.
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50 Current reliable evidence-based medicine resources for the busy clinician -1 American College of Physicians Journal Club http://www.acpj.org American Family Physician http://www.aafp.org/afp Bandolier http://www.rj2.ox.ac.uk/bandolie Clinical Evidence http://www.clinicalevidence.com
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51 Current reliable evidence-based medicine resources for the busy clinician -2 Cochrane Database of Systematic Reviews http://www.cochrane.org/reviews/en/ Database of Abstracts of Reviews of Effects (DARE) http://www.york.ac.uk/inst/crd/crddatabases.htm Dr. Alper's Useful Links http://www.myhq.com/public/a/l/alperDynaMed http://www.dynamicmedical.com Family Practitioners Inquiries Network (FPIN) Clinical Inquiries http://www.fpin.org FIRSTConsult http://www.firstconsult.comInfoPOEMs – The Clinical Awareness Systemhttp://www.infopoems.com
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52 Current reliable evidence-based medicine resources for the busy clinician -3 Institute for Clinical Systems Improvement (ISCI) http://www.icsi.org/knowledge Journal of Family Practice http://www.jfponline.org SUM Search http://sumsearch.uthscsa.edu TRIP Database http://www.tripdatabase.comUpToDate http://www.uptodate.com
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53 Current reliable evidence-based medicine resources for the busy clinician -4 US National Guideline Clearinghouse http://www.guidelines.gov U.S. Preventive Services Task Force (USPSTF) Recommendations http://www.ahrq.gov/clinic/uspstfix.htm
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54 Current reliable evidence-based medicine resources for the busy clinician -5 Bandolier Evidence based thinking about healthcare Cochrane Library Database of Systematic Reviews Full text systematic reviews of health care interventions, prepared by The Cochrane Collaboration. The Database of Abstracts of Reviews of Effects (DARE) Critical appraisal of systematic reviews published in the medical literature. Health Technology Assessment Database (HTA) Completed and on-going health technology assessments from around the world NHS Economic Evaluation Database (NHS EED) Reliable information about the costs as well as the effects of drugs, treatments and procedures, to inform decisions. UK Database of Uncertainties about the Effects of Treatments Publishes those patients' and clinicians' questions about the effects of treatments which cannot currently be answered reliably by referring to up-to-date systematic reviews of existing research.
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55 Web search-6 Clinical evidence.com Cochrane.org Consolidated Standards of Reporting trials= consort-statement.htm National Institute for Health & Clinical excellence (NICE.org.uk Scottish Intercollegiate Guideline Network (SIGN) www.sign.ac.uk
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58 Cochrane
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59 Bandolier
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60 DARE= data base of abstracts of reviews of effects
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63 Web-based evidence-based medicine courses-1 • http://www.poems.msu.edu/infomastery: • http://www.hsl.unc.edu/services/tutorials/ebm/welcome.htm: • http://www.uic.edu/depts/lib/lhsp/resources/ebm.shtml:. • http://library.ncahec.net/ebm/pages/index.htm:
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64 Web-based evidence-based medicine courses-2 http://www.urmc.rochester.edu/hslt/miner/resources/evidence_based/index.cfm: http://library.downstate.edu/EBM2/contents.htm: http://www.healthsystem.virginia.edu/internet/library/collections/ebm/index.cfm: http://www.cebm.net/: http://www.sheffield.ac.uk/∼scharr/ir/netting/:
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65 POEMS Journals with highest frequency of articles that contain patient oriented evidence that matters (POEMs)
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66 Impact factor = average number of citations to those papers that were published during the two preceding years.
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67 Impact factor For example, the 2008 impact factor of a journal would be calculated as follows: A = the number of times articles published in 2006 and 2007 were cited by indexed journals during 2008 B = the total number of "citable items" published in 2006 and 2007. ("Citable items" are usually articles, reviews, proceedings, or notes; not editorials or Letters-to-the-Editor.) 2008 impact factor = A/B
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68 High-impact journals (those cited most frequently by others) Annals of Internal Medicine British Medical Journal Journal of the American Medical Association Lancet New England Journal of Medicine
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69 A new drug project
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70 Preclinical studies Even animal studies need ethical clearance in Europe Efficacy, toxicity and pharmacokinetic data
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71 Phase 0 Human microdosing Distinctive features of Phase 0 trials include the administration of single subtherapeutic doses of the study drug to a small number of subjects (10 to 15) to gather preliminary data on the agent's pharmacokinetics (how the body processes the drug) and pharmacodynamics (how the drug works in the body)
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72 Phase 1 trial Dose escalation =Dose ranging Pharmacovigilance
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73 SAD Single Ascending Dose studies MAD Multiple Ascending Dose studies Crossover study A short trial designed to investigate any differences in absorption of the drug by the body, caused by eating before the drug is given. These studies are usually run as a crossover study, with volunteers being given two identical doses of the drug on different occasions; one while fasted, and one after being fed.
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74 Phase II Larger group Phase IIA is specifically designed to assess dosing requirements (how much drug should be given). Phase IIB is specifically designed to study efficacy (how well the drug works at the prescribed dose(s)).
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75 Phase II Toxixity & efficacy defines go ahead or not
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76 Phase III Phase III studies are randomized controlled multicenter trials on large patient groups (300–3,000 or more depending upon the disease/medical condition studied)
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77 Phase IV Phase IV trial is also known as Post Marketing Surveillance Trial = Pharmacovigilance
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78 Research Design It's always easier to explain design notation through examples than it is to describe it in words. The figure shows the design notation for apretest-posttest (or before-after) treatment versus comparison group randomized
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79 Research Design
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81 Experimental study- steps Animal model Induce tumor by viral inoculation Treat tumor by various laser wavelength Correct wavelength applied in incurable humans Regular Clinical approach
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82 Pilot study Somprakas Basu, Bina Ravi & Ravi Kant: Interstitial laser Hyperthermia, a New Method in the Management of Fibroadenoma of the Breast: A Pilot Study. Lasers in Surgery and Medicine, 1999: Vol. 25: p 148-152.
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85 Interstitial Laser Hyperthermia For solid tumors of- Liver Pancreas Lymph nodes
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91 ILH & Pancreas Kant Ravi, Masters A, Lees WR, Bown SG: Interstitial Laser Hyperthermia in Human pancreas tumors: GUT, supplement 1992. Vol. 33 No 1 W69, p S18.
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92 Lab studies► need infrastructure Hedau S, Jain N, Husain SA, Mandal AK, Ray G, Shahid M, Kant R, Gupta V, Shukla NK, Deo SS, & Das BC. Novel germ line mutations in breast cancer susceptibility genes BRCA1, BRCA2 and p53 gene in breast cancer patients from India. Breast Cancer Research Treat 2004 Nov, 88(2):177-86.
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93 The Liver: The drains do not offer any benefit after elective liver resections. Marcello Spampinato Hassan Elberm & Colin D Johnson in Recent Advances in Surgery # 31, by Irving Taylor & Colin Johnson, The Royal Society of Medicine Press, 2008 page 189- Gurusamy KS, Samraj K, Davidson BR. Routine abdominal drainage for uncomplicated liver resections. Cochrane Database Systemic Rev 2007; CD006232
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94 GB The Gall Bladder: The drains do not offer any benefit after routine uncomplicated laparoscopic cholecystectomy. Marcello Spampinato Hassan Elberm & Colin D Johnson in Recent Advances in Surgery # 31, by Irving Taylor & Colin Johnson, The Royal Society of Medicine Press, 2008 page 196- Gurusamy KS, Samraj K, Mullerat P et al. Routine abdominal drainage for uncomplicated laparoscopic cholecystectomy. Cochrane Database Systemic Rev 2007; CD006004
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95 The Thyroid: No drain is required following thyroidectomy. Khanna J, Mohil RS, Chintamani, Bhatnagar D, Mittal MK, Sahoo M, Mehrotra M. Is the routine drainage after surgery for thyroid necessary? A prospective randomized clinical study [ISRCTN63623153]. BMC Surg. 2005 May 19; 5:11. Suslu N, Vural S, Oncel M, Demirca B, Gezen FC, Tuzun B, Erginel T, Dalkilic G. Is the insertion of drains after uncomplicated thyroid surgery always necessary? Surg Today. 2006; 36(3):215-8. Lee SW, Choi EC, Lee YM et al. Is lack of placement of drains after thyroidectomy with central neck dissections safe? A prospective randomized study. Laryngoscope 2006;116:1632-1635
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96 The Breast: No drain is required after conservation surgery for breast cancer Stojkovic C, Smeulders MJ, Van der Horst CM. Wound drainage after plastic and reconstructive surgery of the breast (Protocol). Cochrane Database of Systematic Reviews 2008, Issue 3. Art. No.: CD007258. DOI: 10.1002/14651858.CD007258.
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97 Rectal Surgery: The pelvic drainage after rectal surgery adds no benefit. Urbach DR, Kennedy ED, Cohen MM. Colon and rectal anastomosis donot require routine drainage: a systemic review and meta-analysis. Ann Surg 1999; 229:174-180.
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98 Incision by electrocautery heal as well as incision by knife. No difference in either postoperative results or in cosmesis. Kears SR, Connolly EM, Mc Nally S, McNamara DA, Deasy J. Randomized clinical trial of diathermy versus scalpel incision in elective midline laparotomy. Br J Surg 2001; 88:41-44.
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99 Summary
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100 Evidence-Based surgery Evidence-base study is a move to find out the best ways of managing patients using clinical evidence from collected studies. Collecting published evidence together and analyzing it often requires review of multiple randomized trials. These meta-analysis involve complex statistical analysis designed to interpret multiple findings and synthesize the results of multiple studies.
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101 Important advantages of evidence-based medicine Has the potential to improve quality of patient care Identifies and promotes practices that are proven scientifically to be effective Identifies practices that are ineffective or harmful Promotes critical thinking Requires clinicians to be open-minded Encourages researchers to focus on evidence and outcomes that are important to clinicians and patients
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104 POEMS patient-oriented evidence that matters (POEMs)
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105 Drains & Evidence Presented in your book as a chapter
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106 Cochrane
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