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• W2950266420 abstract "We would like to thank the authors for publishing this article (Vibe Fersum, Smith, Kvåle, Skouen, & O'Sullivan, 2019). The approach called CFT is very promising and has caught the attention and interest of a huge number of clinicians in the management of non-specific disabling chronic low back pain. We wholeheartedly agree that it is necessary to publish the results of the long-term follow-up even in circumstances where there may be a high risk of bias. Notably, the 1-year follow-up study of Vibe Fersum, O'Sullivan, Skouen, Smith, and Kvåle (2013) already presented a number of methodological shortcomings, such as lack of clear information regarding blinding of assessors. Our concern is that the conclusions of the recent study without emphasizing the risk of attrition bias and how it could have influenced the results can misguide the reader about the reasonable likelihood of false positive. First, in the 3-year follow-up results (Vibe Fersum et al., 2019), the authors considered the pain and disability at 3 years as primary outcomes. However, the trial was registered on Clinical Trials with the time point 1 year as the primary outcome—in agreement with the report of 2013. Therefore, pain and disability at the 3-year follow-up should have been considered as secondary outcomes even when published in a new article. Second, the 1-year follow-up study reported the analysis of the “available cases” (i.e. pairwise deletion or no intention-to-treat) after a substantial exclusion of the participants assigned to the control (27%) and the experimental (18%) groups. Conversely, an intention-to-treat analysis was performed for the 3-year follow-up data. An intention-to-treat analysis of a clinical trial includes all data that can be obtained from each participant and analyses each participant's data in the group to which that participant was randomized, regardless of whether that participant received the allocated intervention (Elkins & Moseley, 2015). There was a substantial violation of intention-to-treat principles with the exclusion of 27/121 patients before 3-month follow-up. Notably, the statement that intention-to-treat analysis was performed for the 3-year follow-up analysis clearly show that the authors have changed their minds during the process and decided to put the excluded participants back to the trial as if it was loss of follow-up (attrition rate of 48%) for the 3-year analysis. It means that we don't know the outcomes of nearly half of the sample. Nevertheless, we know that trials with patient exclusions showed more beneficial effects of the experimental treatment than analyses based on all or most patients randomized (Akl et al., 2012). The same occurs when investigators stop a trial based on an apparently beneficial treatment effect and their results may therefore provide misleading estimates of the benefit (Bassler et al., 2010). Bias may arise because large random fluctuations of the estimated treatment effect. In the case of the 3-year follow-up of Vibe Fersum's trial, the patients lost to follow-up may have a different prognosis than those who have completed the study and therefore poses a potential threat to validity. The Fragility Index (FI) is a measure of the robustness (or fragility) of the results of an randomized clinical trial (RCT) and is an important aid to the clinician's interpretation of RCT results with dichotomous outcome variables (Tignanelli & Napolitano, 2018). The FI is the minimum number of participants whose status would have to change from a non-event (not experiencing the primary end point) to an event (experiencing the primary end point) required to turn a statistically significant result to a non-significant result. Because the outcome—disability—was measured as a continuous variable, we adapted the FI considering a worst-case scenario: how many participants of the intervention group would have to change from an event (the participant's own pre-post treatment change) to a non-event (the average change of the control group) are required to flip the statistical significance of the interaction effect group*phase. Our simulation of 1,000 bootstrap samples using Vibe Fersum's trial summary statistics and same attrition rate with data imputation showed that if only 1 [95% confidence interval 0; 8] participant of the intervention group had the average improvement of the control group would be enough to flip the statistical significance. Therefore, the small sample size and the considerable loss of follow-up resulted in a FI of 1. Vibe Fersum's trial is vulnerable not only due to the high risk of bias but also because of the high risk of random error. Finally, the authors suggest that further studies of CFT are required in different countries. There is an independent RCT that is replicating the Vibe Fersum's trial in Brazil with an approximate date of reporting to July 2020." @default.
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• W2950266420 title "Comment on the paper “Cognitive functional therapy in patients with non specific chronic low back pain”, by Vibe Fersum et al." @default.
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