Reporting the results of meta-analyses: a plea for incorporating clinical relevance referring to an example

Bartels, Ronald H. M. A.; Donk, Roland; Verhagen, W. I. M.; Hosman, Allard J. F.; Verbeek, A.L.M.

doi:10.1016/j.spinee.2017.05.019

Cited by 8 publications

(7 citation statements)

References 35 publications

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“…38 In determining the values for MCID we attempted to base the used values on different publications, each using different methods to approximate MCID. 24,[29][30][31][32][33][34][35][36][37][38][39] Results from this study demonstrate that there is no clinical benefit for ACDA, when compared with ACDF or ACD 2 years after surgery. The small differences with narrow confidence intervals found in this study, especially for the ACDA versus ACD and ACDF versus ACD comparison, are surprising and suggest that this method should not be ruled out in future comparative research.…”

Section: Discussionmentioning

confidence: 99%

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The Clinical Relevance of the Cervical Disc Prosthesis

Goedmakers

Bartels

Donk

et al. 2021

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Study Design. Retrospective analysis was performed on data from 251 patients that were included in two randomized, double-blinded clinical trials comparing clinical results of anterior cervical discectomy and arthroplasty (ACDA) to anterior cervical discectomy and fusion (ACDF), and anterior cervical discectomy (ACD), for single-level disc herniation.Objective. This study aimed to investigate whether the ACDA procedure offers superior clinical results 2 years after surgery, to either ACDF or ACD without instrumentation, in the entire group of patients or in a particular subgroup of patients. Summary of Background Data. The cervical disc prosthesis was introduced to provide superior clinical outcomes after ACD. Methods. Neck Disability Index (NDI), and subscales of the 36-item short-form health survey (SF-36) and McGill pain score were collected at baseline, 1 year and 2 years after surgery. Reoperations and complications were also evaluated. A preliminary subgroup analysis was performed for age, disc height, body mass index (BMI), smoking, and sex. Results. The NDI decreased comparably in all treatment arms to circa 50% of the baseline value and marginal mean NDI differences varied from 0.4 to 1.1 on a 100 point NDI scale, with confidence intervals never exceeding the 20-point minimal clinical important difference (MCID). Secondary outcome parameters showed comparable results. Preliminary subgroup analysis could not demonstrate clinically relevant differences in NDI between treatments after 2 years. Conclusion. After combining data from two Randomized Controlled Trials it can be concluded that there is no clinical benefit for ACDA, when compared with ACDF or ACD 2 years after surgery. Preliminary subgroup analysis indicated outcomes were similar between treatment groups, and that no subgroup could be appointed that benefited more from either ACD, ACDF, or ACDA.

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Section: Discussionmentioning

confidence: 99%

“…Substantial evidence about the MCIDs for the MPQ-DLV is lacking. The importance of incorporating clinical relevance of results in articles is discussed previously 15,33 …”

Section: Methodsmentioning

confidence: 99%

The Clinical Relevance of the Cervical Disc Prosthesis

Goedmakers

Bartels

Donk

et al. 2021

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“…When the literature search was repeated in August 2017, a meta-analysis by Bartels et al was found [6].…”

Section: Literature Search Strategymentioning

confidence: 99%

“…Comparing the results of ACDF and ACDA has been done before in systematic reviews and meta-analyses. An overview of Bartels et al (2017) considered 21 meta-analyses in which the included studies tended to conclude that ACDA gave a better outcome, but differences were small and not clinically relevant [6]. However, it appeared that the meta-analyses considered mainly randomized controlled trials (RCTs) that were performed on mixed patient populations: patients suffering from primarily radiculopathy and patients suffering from primarily myelopathy.…”

Section: Introductionmentioning

confidence: 99%

Cervical radiculopathy: is a prosthesis preferred over fusion surgery? A systematic review

et al. 2019

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Background Meta-analyses on the comparison between fusion and prosthesis in the treatment of cervical radiculopathy mainly analyse studies including mixed patient populations: patients with radiculopathy with and without myelopathy. The outcome for patients with myelopathy is different compared to those without. Furthermore, apart from decompression of the spinal cord, restriction of motion is one of the cornerstones of the surgical treatment of spondylotic myelopathy. From this point of view, the results for arthroplasty might be suboptimal for this category of patients. Comparing clinical outcome in patients exclusively suffering from radiculopathy is therefore a more valid method to compare the true clinical effect of the prosthesis to that of fusion surgery. Aim The objective of this study was to compare clinical outcome of cervical arthroplasty (ACDA) to the clinical outcome of fusion (ACDF) after anterior cervical discectomy in patients exclusively suffering from radiculopathy, and to evaluate differences with mixed patient populations. Methods A literature search was completed in PubMed, EMBASE, Web of Science, COCHRANE, CENTRAL and CINAHL using a sensitive search strategy. Studies were selected by predefined selection criteria (i.a.) patients exclusively suffering from cervical radiculopathy), and risk of bias was assessed using a validated Cochrane Checklist adjusted for this purpose. An additional overview of results was added from articles considering a mix of patients suffering from myelopathy with or without radiculopathy. Results Eight studies were included that exclusively compared intervertebral devices in radiculopathy patients. Additionally, 29 articles concerning patients with myelopathy with or without radiculopathy were studied in a separate results table. All articles showed intermediate to high risk of bias. There was neither a difference in decrease in mean NDI score between the prosthesis (20.6 points) and the fusion (20.3 points) group, nor was there a clinically important difference in neck pain (VAS). Comparing these data to the mixed population data demonstrated comparable mean values, except for the 2-year follow-up NDI values in the prosthesis group: mixed group patients that received a prosthesis reported a mean NDI score Electronic supplementary material The online version of this article (

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“…An MCID is the smallest difference which patients perceive as beneficial and which would mandate a change in patient treatment (Donohue, 2005). Establishing whether an improvement on a clinical endpoint exceeds the MCID is a way to evaluate the clinical relevance of a (new) pharmacological treatment (Make, 2007;Koynova et al, 2013;Bartels et al, 2017).…”

Section: Introductionmentioning

confidence: 99%

Healthcare Professionals’ Preferred Efficacy Endpoints and Minimal Clinically Important Differences in the Assessment of New Medicines for Chronic Obstructive Pulmonary Disease

et al. 2020

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Background: Registration authorities evaluate effects of new medicines for chronic obstructive pulmonary disease (COPD) on airway obstruction, dyspnea, health status and exacerbations. To establish clinical relevance, minimal clinically important differences (MCIDs) are used. The aim of this study was to investigate which efficacy endpoints and MCIDs healthcare professionals consider clinically relevant for new COPD medicines. Materials and Methods: 7,731 Healthcare professionals received an electronic questionnaire. Participants were asked for: 1) preferred efficacy endpoints for new COPD medicines and 2) cutoff values defining clinical relevance for forced expiratory volume in 1 sec (FEV 1), Transition Dyspnea Index (TDI) and St. George's Respiratory Questionnaire (SGRQ). Those cutoff values were compared to the MCIDs used by registration authorities, namely 100 ml for FEV 1 , 1 unit for TDI and 4 units for SGRQ. Results: 227 Healthcare professionals responded to the questionnaire. Most preferred efficacy endpoints were exacerbations (51.0%), airway obstruction (46.9%) and health status (44.9%). Mean cutoff values for TDI and SGRQ were significantly higher than the corresponding MCIDs, mean differences 1.5 (95%CI = 1.3-1.8, p < 0.001) and 7.0 (95% CI = 5.1-8.8, p < 0.001), respectively. The mean cutoff value for FEV 1 was comparable to the MCID (mean difference 2.2, 95%CI =-19.9-24.3, p = 0.84). Conclusions: Healthcare professionals largely agree with efficacy endpoints used for the evaluation of new COPD medicines. However, they seem to prefer higher cutoff values for clinical relevance for TDI and SGRQ than the registration authorities. Effects of new

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Reporting the results of meta-analyses: a plea for incorporating clinical relevance referring to an example

Cited by 8 publications

References 35 publications

The Clinical Relevance of the Cervical Disc Prosthesis

The Clinical Relevance of the Cervical Disc Prosthesis

Cervical radiculopathy: is a prosthesis preferred over fusion surgery? A systematic review

Healthcare Professionals’ Preferred Efficacy Endpoints and Minimal Clinically Important Differences in the Assessment of New Medicines for Chronic Obstructive Pulmonary Disease

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