Escaping the Scalpel

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12 CHAPTER I ment effectiveness. [31, 32] Therefore, the old guideline does not make any statement on the treatment for degenerative meniscal tears.[32] Whereas, the current Dutch, but also international guidelines, recommend against surgical treatment for middle aged and older patients with a degenerative meniscus tear and nonsurgical management should last for at least 3 months.[1, 29, 31] Despite that the guidelines recommend nonsurgical treatment, meniscus surgery is still frequently performed in middle aged and older patients with a meniscus tear.[4, 28] It seems that with 25.992 (75%) of the arthroscopic partial meniscectomies performed in patients over 40 years old in 2005, and still 20.833 (70%) in 2014, clinicians are not convinced by the evidence and uncertain about the quality of the current evidence.[3, 5] A non-inferiority design can fill this knowledge gap and provide high quality evidence that is need to empower clinicians in their evidence-based treatment decisions.[26] Figure 2. Different examples of non-inferiority results and interpretation In favor of intervention In favor of control treatment A Non-inferior and superior B Non-inferior C Inconclusive D inferior 0 Non-inferiority margin A. The upper limit of the 95% confidence interval of the between-group difference is smaller than the non-inferiority margin and zero. The intervention is non-inferior and superior compared to the control treatment. B. The upper limit of the 95% confidence interval of the between-group difference is smaller than the non-inferiority margin. The intervention is non-inferior compared to the control treatment. C. The upper limit 95% confidence interval crosses the non-inferiority margin, therefore the between group difference is not smaller. The result is inconclusive. D. The lower limit of the 95% confidence interval of the between-group is greater than the noninferiority margin. The intervention is inferiortothe control treatment Methodological considerations Noninferiority studies provide evidence whether an intervention (in this thesis: exercisebased physical therapy) is or is not less effective compared to the control treatment (in this thesis: meniscus surgery).[26] This study design is appropriate when the intervention has
GENERAL INTRODUCTION13 potential benefits over the control treatment. For instance, exercise-based physical therapy has a lower risk of complications, is less invasive and cheaper compared to meniscus surgery. Prior to the study a non-inferiority margin is defined, which indicates the threshold of clinical relevance for the outcome measure of interest. With noninferiority testing the between group difference (i.e. the mean difference and the upper limit of the 95% confidence intervals) is tested in respect to the non-inferiority margin, rather than with respect to zero. [26] Figure 2 displays an example of noninferiority figure and an explanation of the conclusions one can draw from these results. I Although results of RCTs are important to determine the effectiveness of treatments, they cannot always directly be implemented in clinical practice due to the experimental nature of an RCT that can result in a discrepancy between the study population and the general population seen in clinical practice, or due to healthcare policy rules and regulations. Besides, the RCT-based treatment recommendations do not account for the individual variation in treatment effect and are therefore not always applicable to the individual patient.[19] For instance, in the published trials an average of 24% (range 1.9 to 36%) of the patients underwent delayed meniscus surgery after initial physical therapy failed.[2] Published prognostic models cannot accurately predict treatment outcome or select subgroups of patients who benefit from either meniscus surgery or physical therapy.[16, 27, 34] With the growing interest in personalized medicine, professional guidelines for clinical prediction models have been established [23] and advanced statistical methods have been proposed to account for heterogeneity of treatment effects [18]. The TRIPOD statement is a guideline for multivariable prognostic models in which baseline variables are combined and the model is internally validate to correct for a possible overestimation of the models’ accuracy.[23] Another, more advanced, approach is a Marker-by-Treatment analyses.[13, 19] This novel approach in orthopedic research, provides specific cut-off points for patient characteristics to determine which treatment, exercise-based physical therapy or meniscus surgery gives the best outcome.[19] This thesis will apply two prognostic techniques to RCT data, in order to strengthen the evidence base for treatment of patients with degenerative meniscus tears. ESCAPE Trial This thesis is an in-depth analyses and continuation of the ESCAPE trial. The ESCAPE trial is a multi-center randomized controlled trial with a noninferiority design comparing meniscus surgery with exercise-based physical therapy.[36] We enrolled patients for the ESCAPE trial in nine participating hospitals in The Netherlands. The inclusion and exclusion criteria are displayed in figure 3.[36]
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64 CHAPTER IV Multivariable regress
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66 CHAPTER IV Discussion Two progno
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68 CHAPTER IV References 1. Abram S
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Chapter 5 An individualized decisio
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98 CHAPTER VI score (range, 0 [best
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100 CHAPTER VI Results Patients We
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102 CHAPTER VI Table 1. Baseline ch
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104 CHAPTER VI Over the 5 years of
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108 CHAPTER VI Table 3. Five year o
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110 CHAPTER VI of exercise-based ph
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114 CHAPTER VI 33. Pihl K, Ensor J,
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Chapter 7 General Discussion
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GENERAL DISCUSSION & CONCLUSION119
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128 CHAPTER VIII What we already kn
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130 CHAPTER VIII analyses to reveal
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132 CHAPTER VIII References 1. Abra
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134 CHAPTER VIII basis van de activ
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Chapter 9 Appendices
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APPENDICES139 Appendix 1 Physical t
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APPENDICES141 Appendix 2 Patient in
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APPENDICES143 We determined the opt
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APPENDICES145 Appendix 5 Detail des
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APPENDICES147 Appendix 6 Table of c
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APPENDICES149 Appendix 8 An example
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APPENDICES151 IX
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154 CHAPTER X List of publications
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156 CHAPTER X Honors and awards 201
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158 CHAPTER X Lieve Victor, ‘jouw
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