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Evidence-based Dentistry

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An introduction to basics of Evidence-based Dentistry techniques with a special emphasis on orthodontics.

Veröffentlicht in: Gesundheit & Medizin

Evidence-based Dentistry

  1. 1. Evidence-based Dentistry Nalaka Jayaratne BDS, PhD Resident in Orthodontics, University of Connecticut School of Dental Medicine USA
  2. 2. Evidence-based Dentistry
  3. 3. Evidence-based Dentistry  ADA Definition - an approach to oral health care that requires the judicious integration of systematic assessments of clinically relevant scientific evidence, relating to the patient's oral and medical condition and history, with the dentist's clinical expertise and the patient's treatment needs and preference
  4. 4. Why is evidence-based dentistry important?
  5. 5. Why is evidence-based dentistry important?  To improve quality of health-care delivery
  6. 6. Why is evidence-based dentistry important?  To improve quality of health-care delivery  By incorporating effective practices
  7. 7. Why is evidence-based dentistry important?  To improve quality of health-care delivery  By incorporating effective practices  While eliminating those that are ineffective or inappropriate
  8. 8. The five steps of evidence-based dentistry practice
  9. 9. The five steps of evidence-based dentistry practice 1. Developing a clear, clinically focused question
  10. 10. The five steps of evidence-based dentistry practice 1. Developing a clear, clinically focused question 2. Identifying, summarizing, and synthesizing all relevant studies that directly answer the formulated question
  11. 11. The five steps of evidence-based dentistry practice 1. Developing a clear, clinically focused question 2. Identifying, summarizing, and synthesizing all relevant studies that directly answer the formulated question 3. Appraising evidence in terms of validity and applicability
  12. 12. The five steps of evidence-based dentistry practice 1. Developing a clear, clinically focused question 2. Identifying, summarizing, and synthesizing all relevant studies that directly answer the formulated question 3. Appraising evidence in terms of validity and applicability 4. Combining research evidence with clinical expertise and patients characteristics
  13. 13. The five steps of evidence-based dentistry practice 1. Developing a clear, clinically focused question 2. Identifying, summarizing, and synthesizing all relevant studies that directly answer the formulated question 3. Appraising evidence in terms of validity and applicability 4. Combining research evidence with clinical expertise and patients characteristics 5. Assessing the successful implementation of previous steps
  14. 14. Level Evidence 1++ High-quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias 1+ Well-conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias 1- Meta-analyses, systematic reviews or RCTs, or RCTs with a high risk of bias 2++ High-quality systematic reviews of case-control or cohort studies or high-quality case-control or cohort studies with a very low risk of confounding, bias, or chance and a high probability that the relationship is causal 2+ Well-conducted case-control or cohort studies with a low risk of confounding, bias, or chance and a moderate probability that the relationship is causal 2- Case-control or cohort studies with a high risk of confounding, bias, or chance and a significant risk that the relationship is not causal 3 Non-analytic studies, e.g., case reports, case series 4 Expert opinion Scottish Intercollegiate Guidelines Network (SIGN) Revised grading system for recommendations in evidence-based guidelines
  15. 15. Level Evidence 1++ High-quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias 1+ Well-conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias 1- Meta-analyses, systematic reviews or RCTs, or RCTs with a high risk of bias 2++ High-quality systematic reviews of case-control or cohort studies or high-quality case-control or cohort studies with a very low risk of confounding, bias, or chance and a high probability that the relationship is causal 2+ Well-conducted case-control or cohort studies with a low risk of confounding, bias, or chance and a moderate probability that the relationship is causal 2- Case-control or cohort studies with a high risk of confounding, bias, or chance and a significant risk that the relationship is not causal 3 Non-analytic studies, e.g., case reports, case series 4 Expert opinion Scottish Intercollegiate Guidelines Network (SIGN) Revised grading system for recommendations in evidence-based guidelines
  16. 16. Level Evidence 1++ High-quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias 1+ Well-conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias 1- Meta-analyses, systematic reviews or RCTs, or RCTs with a high risk of bias 2++ High-quality systematic reviews of case-control or cohort studies or high-quality case-control or cohort studies with a very low risk of confounding, bias, or chance and a high probability that the relationship is causal 2+ Well-conducted case-control or cohort studies with a low risk of confounding, bias, or chance and a moderate probability that the relationship is causal 2- Case-control or cohort studies with a high risk of confounding, bias, or chance and a significant risk that the relationship is not causal 3 Non-analytic studies, e.g., case reports, case series 4 Expert opinion Scottish Intercollegiate Guidelines Network (SIGN) Revised grading system for recommendations in evidence-based guidelines
  17. 17. Level Evidence 1++ High-quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias 1+ Well-conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias 1- Meta-analyses, systematic reviews or RCTs, or RCTs with a high risk of bias 2++ High-quality systematic reviews of case-control or cohort studies or high-quality case-control or cohort studies with a very low risk of confounding, bias, or chance and a high probability that the relationship is causal 2+ Well-conducted case-control or cohort studies with a low risk of confounding, bias, or chance and a moderate probability that the relationship is causal 2- Case-control or cohort studies with a high risk of confounding, bias, or chance and a significant risk that the relationship is not causal 3 Non-analytic studies, e.g., case reports, case series 4 Expert opinion Scottish Intercollegiate Guidelines Network (SIGN) Revised grading system for recommendations in evidence-based guidelines
  18. 18. Features of RCT’s
  19. 19. Features of RCT’s  Rarticipants are randomly assigned
  20. 20. Features of RCT’s  Rarticipants are randomly assigned  Comparative - Treatment group compared with control group with similar characteristics
  21. 21. Features of RCT’s  Rarticipants are randomly assigned  Comparative - Treatment group compared with control group with similar characteristics  Allocation concealment
  22. 22. Features of RCT’s  Rarticipants are randomly assigned  Comparative - Treatment group compared with control group with similar characteristics  Allocation concealment  Blinding
  23. 23. Features of RCT’s  Rarticipants are randomly assigned  Comparative - Treatment group compared with control group with similar characteristics  Allocation concealment  Blinding  Is the most scientifically rigorous method of hypothesis testing  gold standard
  24. 24. Bias in RCT’s Type of bias Prevention / elimination of bias Selection bias Proper randomization Performance bias Blinding of participants and people administering treatment Detection bias Blinding of outcome assessors/analyzers Attrition bias Intention-to-treat analysis Publication bias Trial registration, no selective reporting
  25. 25. Bias in RCT’s Type of bias Prevention / elimination of bias Selection bias Proper randomization Performance bias Blinding of participants and people administering treatment Detection bias Blinding of outcome assessors/analyzers Attrition bias Intention-to-treat analysis Publication bias Trial registration, no selective reporting
  26. 26. Bias in RCT’s Type of bias Prevention / elimination of bias Selection bias Proper randomization Performance bias Blinding of participants and people administering treatment Detection bias Blinding of outcome assessors/analyzers Attrition bias Intention-to-treat analysis Publication bias Trial registration, no selective reporting
  27. 27. Bias in RCT’s Type of bias Prevention / elimination of bias Selection bias Proper randomization Performance bias Blinding of participants and people administering treatment Detection bias Blinding of outcome assessors/analyzers Attrition bias Intention-to-treat analysis Publication bias Trial registration, no selective reporting
  28. 28. Bias in RCT’s Type of bias Prevention / elimination of bias Selection bias Proper randomization Performance bias Blinding of participants and people administering treatment Detection bias Blinding of outcome assessors/analyzers Attrition bias Intention-to-treat analysis Publication bias Trial registration, no selective reporting
  29. 29. Bias in RCT’s Type of bias Prevention / elimination of bias Selection bias Proper randomization Performance bias Blinding of participants and people administering treatment Detection bias Blinding of outcome assessors/analyzers Attrition bias Intention-to-treat analysis Publication bias Trial registration, no selective reporting
  30. 30. Systematic Review  A research article that,
  31. 31. Systematic Review  A research article that, o Identify relevant studies
  32. 32. Systematic Review  A research article that, o Identify relevant studies o Appraises their quality
  33. 33. Systematic Review  A research article that, o Identify relevant studies o Appraises their quality o Summarizes their results using scientific methodology
  34. 34. Meta-analysis Systematic Review Systematic ReviewMeta-Analysis
  35. 35. Meta-analysis  The use of statistical techniques to combine the results of studies addressing the same question into a summary measure Systematic Review Systematic ReviewMeta-Analysis
  36. 36. Meta-analysis  The use of statistical techniques to combine the results of studies addressing the same question into a summary measure  Increases the size of the `overall sample’  enhances statistical power Systematic Review Systematic ReviewMeta-Analysis
  37. 37. Meta-analysis  The use of statistical techniques to combine the results of studies addressing the same question into a summary measure  Increases the size of the `overall sample’  enhances statistical power  Quantitative synthesis  only when the studies to be combined are clinically and statistically homogeneous Systematic Review Systematic ReviewMeta-Analysis
  38. 38. Meta-analysis  The use of statistical techniques to combine the results of studies addressing the same question into a summary measure  Increases the size of the `overall sample’  enhances statistical power  Quantitative synthesis  only when the studies to be combined are clinically and statistically homogeneous  Systematic Review ≠ Meta-Analysis Systematic Review Systematic ReviewMeta-Analysis
  39. 39. What are Cochrane reviews?
  40. 40. What are Cochrane reviews?  The Cochrane Collaboration is an international organization that aims to organize medical research information in a systematic way promoting the accessibility of systematic reviews of the effects of health- care interventions
  41. 41. What are Cochrane reviews?  The Cochrane Collaboration is an international organization that aims to organize medical research information in a systematic way promoting the accessibility of systematic reviews of the effects of health- care interventions  Systematic reviews of primary research in human health care and health policy, undertaken by members of The Cochrane Collaboration adhering to a specific methodology
  42. 42. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)
  43. 43. Assessing the quality Assessment of Multiple Systematic Reviews - AMSTAR
  44. 44. This article is the result of a debate at the European Journal of Orthodontics Open Session in 2013 in Reykjavik, Iceland
  45. 45. Part I: RCTs are for orthodontics Lars Bondemark
  46. 46. Part I: RCTs are for orthodontics  The first published RCT 1948 ‘Streptomycin treatment of pulmonary tuberculosis’ Lars Bondemark
  47. 47. Part I: RCTs are for orthodontics  The first published RCT 1948 ‘Streptomycin treatment of pulmonary tuberculosis’ Orthodontic RCTs per year between 1990 and 2013 Lars Bondemark
  48. 48. Randomization
  49. 49. Randomization  Ensures both known and unknown determinants are evenly distributed among the different study groups
  50. 50. Randomization  Ensures both known and unknown determinants are evenly distributed among the different study groups  Minimizes bias in assessment of differences in effects between two or more treatment alternatives Confounding factors equally distributed
  51. 51. Randomization  Ensures both known and unknown determinants are evenly distributed among the different study groups  Minimizes bias in assessment of differences in effects between two or more treatment alternatives Confounding factors equally distributed  Idea with randomization is that the treatment will be the only thing that will constitute a significant difference between the patient groups
  52. 52. Randomization  Ensures both known and unknown determinants are evenly distributed among the different study groups  Minimizes bias in assessment of differences in effects between two or more treatment alternatives Confounding factors equally distributed  Idea with randomization is that the treatment will be the only thing that will constitute a significant difference between the patient groups  Best if done by an independent person
  53. 53. CONSORT  Consolidated Standards of Reporting Trials
  54. 54. Recommendations
  55. 55. Recommendations  Create a relevant question use PICO
  56. 56. Recommendations  Create a relevant question use PICO • P - population • I - intervention • C - control • O - outcome
  57. 57. Recommendations  Create a relevant question use PICO • P - population • I - intervention • C - control • O - outcome e.g. Is Quad-helix treatment (intervention) more cost-effective (outcome) than platal expansion (control) in 8–10 year-old patients with unilateral posterior crossbite (population)?
  58. 58. Recommendations  Create a relevant question use PICO • P - population • I - intervention • C - control • O - outcome e.g. Is Quad-helix treatment (intervention) more cost-effective (outcome) than platal expansion (control) in 8–10 year-old patients with unilateral posterior crossbite (population)?  Use proper randomization
  59. 59. Recommendations  Create a relevant question use PICO • P - population • I - intervention • C - control • O - outcome e.g. Is Quad-helix treatment (intervention) more cost-effective (outcome) than platal expansion (control) in 8–10 year-old patients with unilateral posterior crossbite (population)?  Use proper randomization  Plan and coordinate the trial carefully - have patience since it takes time to run an RCT
  60. 60. Recommendations  Create a relevant question use PICO • P - population • I - intervention • C - control • O - outcome e.g. Is Quad-helix treatment (intervention) more cost-effective (outcome) than platal expansion (control) in 8–10 year-old patients with unilateral posterior crossbite (population)?  Use proper randomization  Plan and coordinate the trial carefully - have patience since it takes time to run an RCT  Have sufficient sample size – if small, greater risk of unknown or confounding factors that may interfere the outcomes
  61. 61. Recommendations  Create a relevant question use PICO • P - population • I - intervention • C - control • O - outcome e.g. Is Quad-helix treatment (intervention) more cost-effective (outcome) than platal expansion (control) in 8–10 year-old patients with unilateral posterior crossbite (population)?  Use proper randomization  Plan and coordinate the trial carefully - have patience since it takes time to run an RCT  Have sufficient sample size – if small, greater risk of unknown or confounding factors that may interfere the outcomes  Use valid and reliable methods
  62. 62. Recommendations  Create a relevant question use PICO • P - population • I - intervention • C - control • O - outcome e.g. Is Quad-helix treatment (intervention) more cost-effective (outcome) than platal expansion (control) in 8–10 year-old patients with unilateral posterior crossbite (population)?  Use proper randomization  Plan and coordinate the trial carefully - have patience since it takes time to run an RCT  Have sufficient sample size – if small, greater risk of unknown or confounding factors that may interfere the outcomes  Use valid and reliable methods  Follow the CONSORT statement
  63. 63. Recommendations  Create a relevant question use PICO • P - population • I - intervention • C - control • O - outcome e.g. Is Quad-helix treatment (intervention) more cost-effective (outcome) than platal expansion (control) in 8–10 year-old patients with unilateral posterior crossbite (population)?  Use proper randomization  Plan and coordinate the trial carefully - have patience since it takes time to run an RCT  Have sufficient sample size – if small, greater risk of unknown or confounding factors that may interfere the outcomes  Use valid and reliable methods  Follow the CONSORT statement  Use blinding if possible
  64. 64. Recommendations  Create a relevant question use PICO • P - population • I - intervention • C - control • O - outcome e.g. Is Quad-helix treatment (intervention) more cost-effective (outcome) than platal expansion (control) in 8–10 year-old patients with unilateral posterior crossbite (population)?  Use proper randomization  Plan and coordinate the trial carefully - have patience since it takes time to run an RCT  Have sufficient sample size – if small, greater risk of unknown or confounding factors that may interfere the outcomes  Use valid and reliable methods  Follow the CONSORT statement  Use blinding if possible  Use the Intention-to-treat (ITT)analysis to evaluate the results
  65. 65. Intention-to-treat Analysis https://www.youtube.com/watch?v=nnxg0FJwPjY
  66. 66. Part II: RCTs are not for orthodontics Sabine Ruf
  67. 67. Part II: RCTs are not for orthodontics  New EBM ideology - RCTs may minimize, but do not eliminate bias Sabine Ruf
  68. 68. Why RCTs are not ‘working’ for crucial clinical orthodontic questions?
  69. 69. Why RCTs are not ‘working’ for crucial clinical orthodontic questions?  Primary goal of RCT  test whether an intervention works by comparing it to a control condition
  70. 70. Why RCTs are not ‘working’ for crucial clinical orthodontic questions?  Primary goal of RCT  test whether an intervention works by comparing it to a control condition o No treatment o A placebo treatment o An alternative treatment
  71. 71. Why RCTs are not ‘working’ for crucial clinical orthodontic questions?  Primary goal of RCT  test whether an intervention works by comparing it to a control condition o No treatment o A placebo treatment o An alternative treatment  Orthodontics is a device-driven specialty  not a series of pills that can be administered at random and evaluated blindly
  72. 72. Why RCTs are not ‘working’ for crucial clinical orthodontic questions?  Primary goal of RCT  test whether an intervention works by comparing it to a control condition o No treatment o A placebo treatment o An alternative treatment  Orthodontics is a device-driven specialty  not a series of pills that can be administered at random and evaluated blindly  Even ‘invisible’ appliances are visible to the pt & operator
  73. 73. Why RCTs are not ‘working’ for crucial clinical orthodontic questions?  Primary goal of RCT  test whether an intervention works by comparing it to a control condition o No treatment o A placebo treatment o An alternative treatment  Orthodontics is a device-driven specialty  not a series of pills that can be administered at random and evaluated blindly  Even ‘invisible’ appliances are visible to the pt & operator  Excludes the possibility of orthodontic placebo treatments at least for the majority of the questions
  74. 74. Effect of Informed Consent
  75. 75. Effect of Informed Consent  RCT by Bergmann et al. in 1994, shortly before informed consent became mandatory in France
  76. 76. Effect of Informed Consent  RCT by Bergmann et al. in 1994, shortly before informed consent became mandatory in France  Aim: Effect of informed consent on analgesic activity of pain killers
  77. 77. Effect of Informed Consent  RCT by Bergmann et al. in 1994, shortly before informed consent became mandatory in France  Aim: Effect of informed consent on analgesic activity of pain killers  49 consecutively hospitalized patients with mild to moderate cancer pain
  78. 78. Effect of Informed Consent  RCT by Bergmann et al. in 1994, shortly before informed consent became mandatory in France  Aim: Effect of informed consent on analgesic activity of pain killers  49 consecutively hospitalized patients with mild to moderate cancer pain  Uninformed group - 25 received both treatments without any information
  79. 79. Effect of Informed Consent  RCT by Bergmann et al. in 1994, shortly before informed consent became mandatory in France  Aim: Effect of informed consent on analgesic activity of pain killers  49 consecutively hospitalized patients with mild to moderate cancer pain  Uninformed group - 25 received both treatments without any information  Informed-consent group - 24 had a complete information about the trial; 6 refused to participate 18 pt’s
  80. 80. Effect of Informed Consent  RCT by Bergmann et al. in 1994, shortly before informed consent became mandatory in France  Aim: Effect of informed consent on analgesic activity of pain killers  49 consecutively hospitalized patients with mild to moderate cancer pain  Uninformed group - 25 received both treatments without any information  Informed-consent group - 24 had a complete information about the trial; 6 refused to participate 18 pt’s  VAS score of pain before and 30, 60, 120 and 180 min after the intake of naproxen and placebo were recorded
  81. 81. Changes (mm) in VAS pain levels after naproxen or placebo intake in patients with and without informed consent
  82. 82. Changes (mm) in VAS pain levels after naproxen or placebo intake in patients with and without informed consent Pain reduces with the drug in the non-informed group Pain increases after receiving the placebo in the non-informed group
  83. 83. Changes (mm) in VAS pain levels after naproxen or placebo intake in patients with and without informed consent Pain reduces in both the drug and placebo in the informed consent group
  84. 84.  First described in the 1950s by Henry A. Landsberger after experiments conducted at the Hawthorne works electric company to determine if increasing or decreasing the amount of light workers received would have an effect on worker productivity  Employee productivity seemed to increase due to the changes, but then decreased at after the experiment was over  Researchers suggested that productivity increased due to attention from the research team and not because of changes to the experimental variables  Lansdberger defined the Hawthorne effect as a short-term improvement in performance caused by observing workers
  85. 85. All orthodontic treatment modalities requiring cooperation cannot be tested reliably using a RCT design, at least not if we are seeking clinically relevant truth. And that is maybe ‘why RCTs in orthodontics have not achieved their intended objective
  86. 86. Drawbacks of RCT’s  High costs  Ethical problems  Informed consent  Bias problems  Clinicians/patients preference for certain treatment  Recruiting sufficient patients
  87. 87. Final Thoughts  Lack of evidence does not necessarily imply lack of effect  Instead, there is need for further relevant evaluations. Clearly, new well-designed RCTs and non-randomized studies can achieve important support to reliable evidence in orthodontics

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