Investigating the veracity of a sample of divergent published trial data in spinal pain
PAIN: April 25, 2022 - Volume - Issue - 10.1097/j.pain.0000000000002659
Abstract In Brief: Evidence-based medicine is replete with studies assessing quality and bias, but few evaluating research integrity or trustworthiness. A recent Cochrane review of psychological interventions for chronic pain identified trials with a shared lead author with highly divergent results. We sought to systematically identify all similar trials from this author to explore their risk of bias, governance procedures, and trustworthiness. We searched OVID MEDLINE, EMBASE, CENTRAL, and PEDro from 2010 to December 22, 2021 for trials. We contacted the authors requesting details of trial registration, ethical approval, protocol, and access to the trial data for verification. We used the Cochrane risk-of-bias tool and the Cochrane Pregnancy and Childbirth group's Trustworthiness Screening Tool to guide systematic exploration of trustworthiness.
Ten trials were included: 9 compared cognitive behavioural therapy and physical exercise to usual care, exercise alone, or physiotherapy and 1 compared 2 brief cognitive behavioural therapy programmes. Eight trials reported results divergent from the evidence base. Assessment of risk of bias and participant characteristics identified no substantial concerns. Responses from the lead author did not satisfactorily explain this divergence. Trustworthiness screening identified concerns about research governance, data plausibility at baseline, the results, and apparent data duplication. We discuss the findings within the context of methods for establishing the trustworthiness of research findings generally. Important concerns regarding the trustworthiness of these trials reduce our confidence in them. They should probably not be used to inform the results and conclusions of systematic reviews, in clinical training, policy documents, or any relevant instruction regarding adult chronic pain management.
On that basis we designed a protocol to systematically identify trials in this field from this author and explore aspects of the trustworthiness of the trials. We use a tool developed by the Cochrane Pregnancy and Childbirth group for this. To summarise our findings, we found 10 trials and identified a number of concerns across those trials that included: a lack of trial pre-registration, baseline values that did not seem consistent with randomisation, cases of erroneous (impossible) p values in baseline tables, extremely large effect sizes at both short and long-term follow up, (which is something that is really not common in the field of chronic pain and certainly not seen in other trials of CBT), and notably low or zero attrition in some studies. In addition we identified identical, and highly similar data across 3 trials reported as independent studies. On that basis we recommended that these trials should probably not be used to inform the results and conclusions of systematic reviews, in clinical training, policy documents, or any relevant instruction regarding adult chronic pain management. Neil O’Connell
For complete commentary go to Pain researchers lose three papers after Cochrane group questioned data – Retraction Watch
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