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Evidence-based Dentistry
This document discusses evidence-based dentistry and randomized controlled trials (RCTs) in orthodontics. It defines evidence-based dentistry as integrating systematic assessments of scientific evidence with clinical expertise and patient preferences. RCTs are described as the gold standard for testing hypotheses as they minimize bias through randomization and blinding. However, RCTs can be challenging to conduct in orthodontics due to long treatment times and variability between patients. Recommendations for improving RCT quality include clearly defining the research question, proper randomization, sufficient sample sizes, and using valid and reliable methods.
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Evidence-based Dentistry
- 1. Evidence-based Dentistry Nalaka JayaratneBDS, PhD Resident in Orthodontics, University of Connecticut School of Dental Medicine USA
- 3.
- 4. Evidence-based Dentistry ADADefinition - 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
- 5. Why is evidence-baseddentistry important?
- 6. Why is evidence-baseddentistry important? To improve quality of health-care delivery
- 7. Why is evidence-baseddentistry important? To improve quality of health-care delivery By incorporating effective practices
- 8. Why is evidence-baseddentistry important? To improve quality of health-care delivery By incorporating effective practices While eliminating those that are ineffective or inappropriate
- 9. The five stepsof evidence-based dentistry practice
- 10. The five stepsof evidence-based dentistry practice 1. Developing a clear, clinically focused question
- 11. The five stepsof 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
- 12. The five stepsof 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
- 13. The five stepsof 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
- 14. The five stepsof 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
- 16. Level Evidence 1++ High-qualitymeta-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. Level Evidence 1++ High-qualitymeta-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. Level Evidence 1++ High-qualitymeta-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
- 19. Level Evidence 1++ High-qualitymeta-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
- 20.
- 21. Features of RCT’s Rarticipants are randomly assigned
- 22. Features of RCT’s Rarticipants are randomly assigned Comparative - Treatment group compared with control group with similar characteristics
- 23. Features of RCT’s Rarticipants are randomly assigned Comparative - Treatment group compared with control group with similar characteristics Allocation concealment
- 24. Features of RCT’s Rarticipants are randomly assigned Comparative - Treatment group compared with control group with similar characteristics Allocation concealment Blinding
- 25. 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
- 26. Bias in RCT’s Typeof 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. Bias in RCT’s Typeof 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. Bias in RCT’s Typeof 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. Bias in RCT’s Typeof 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. Bias in RCT’s Typeof 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
- 31. Bias in RCT’s Typeof 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
- 32. Systematic Review Aresearch article that,
- 33. Systematic Review Aresearch article that, o Identify relevant studies
- 34. Systematic Review Aresearch article that, o Identify relevant studies o Appraises their quality
- 35. Systematic Review Aresearch article that, o Identify relevant studies o Appraises their quality o Summarizes their results using scientific methodology
- 36.
- 37. Meta-analysis The useof statistical techniques to combine the results of studies addressing the same question into a summary measure Systematic Review Systematic ReviewMeta-Analysis
- 38. Meta-analysis The useof 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
- 39. Meta-analysis The useof 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
- 40. Meta-analysis The useof 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
- 48. What are Cochranereviews?
- 49. What are Cochranereviews? 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
- 50. What are Cochranereviews? 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
- 51. Preferred Reporting Itemsfor Systematic Reviews and Meta-Analyses (PRISMA)
- 52. Assessing the quality Assessmentof Multiple Systematic Reviews - AMSTAR
- 53. This article isthe result of a debate at the European Journal of Orthodontics Open Session in 2013 in Reykjavik, Iceland
- 54. Part I: RCTsare for orthodontics Lars Bondemark
- 55. Part I: RCTsare for orthodontics The first published RCT 1948 ‘Streptomycin treatment of pulmonary tuberculosis’ Lars Bondemark
- 56. Part I: RCTsare for orthodontics The first published RCT 1948 ‘Streptomycin treatment of pulmonary tuberculosis’ Orthodontic RCTs per year between 1990 and 2013 Lars Bondemark
- 57.
- 58. Randomization Ensures bothknown and unknown determinants are evenly distributed among the different study groups
- 59. Randomization Ensures bothknown 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
- 60. Randomization Ensures bothknown 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
- 61. Randomization Ensures bothknown 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
- 62. CONSORT Consolidated Standardsof Reporting Trials
- 63.
- 64. Recommendations Create arelevant question use PICO
- 65. Recommendations Create arelevant question use PICO • P - population • I - intervention • C - control • O - outcome
- 66. Recommendations Create arelevant 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)?
- 67. Recommendations Create arelevant 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
- 68. Recommendations Create arelevant 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
- 69. Recommendations Create arelevant 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
- 70. Recommendations Create arelevant 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
- 71. Recommendations Create arelevant 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
- 72. Recommendations Create arelevant 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
- 73. Recommendations Create arelevant 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
- 74.
- 75. Part II: RCTsare not for orthodontics Sabine Ruf
- 76. Part II: RCTsare not for orthodontics New EBM ideology - RCTs may minimize, but do not eliminate bias Sabine Ruf
- 77. Why RCTs arenot ‘working’ for crucial clinical orthodontic questions?
- 78. Why RCTs arenot ‘working’ for crucial clinical orthodontic questions? Primary goal of RCT test whether an intervention works by comparing it to a control condition
- 79. Why RCTs arenot ‘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
- 80. Why RCTs arenot ‘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
- 81. Why RCTs arenot ‘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
- 82. Why RCTs arenot ‘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
- 83. Effect of InformedConsent
- 84. Effect of InformedConsent RCT by Bergmann et al. in 1994, shortly before informed consent became mandatory in France
- 85. Effect of InformedConsent 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
- 86. Effect of InformedConsent 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
- 87. Effect of InformedConsent 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
- 88. Effect of InformedConsent 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
- 89. Effect of InformedConsent 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
- 90. Changes (mm) inVAS pain levels after naproxen or placebo intake in patients with and without informed consent
- 91. Changes (mm) inVAS 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
- 92. Changes (mm) inVAS 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
- 93. First describedin 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
- 94. All orthodontic treatmentmodalities 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
- 95. Drawbacks of RCT’s High costs Ethical problems Informed consent Bias problems Clinicians/patients preference for certain treatment Recruiting sufficient patients
- 96. Final Thoughts Lackof 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