Pain researcher in Italy up to seven retractions

A physiatrist in Italy has lost four publications this year after two groups of researchers raised concerns about his research.

The physician, Marco Monticone, a professor at the University of Cagliari, had three papers pulled in 2022, as we reported at the time. Those retractions followed a critique by Cochrane researchers who analyzed data in 10 randomized controlled trials (RCTs) headed by Monticone.

Neil O’Connell, of Brunel University of London, lead author of the critique, told us:

In eight trials we found serious concerns that we felt amounted to a body of evidence that warrants consideration for retraction. The 2 trials that look like outsiders were both small pilot studies (2014, 2018) with some concerns but less clear. However, after our investigation we flagged all 10 trials to the respective editors and shared our work. There is a wider question of trust when concerns are raised across multiple papers from a single author team.

In February of this year, The Clinical Journal of Pain retracted one more of the studies flagged by O’Connell’s team, “Effect of a Long-lasting Multidisciplinary Program on Disability and Fear-Avoidance Behaviors in Patients With Chronic Low Back Pain Results of a Randomized Controlled Trial.” The notice cited the critique, stating:

When approached for an explanation, the authors provided detailed responses; however, they were unable to provide an adequate explanation that satisfactorily addressed our concerns, which includes the veracity of the data presented in the article. The authors have been informed of the decision to retract their article from this Journal, and have published a response in the journal Pain [see “Untrustworthiness of trial data on spinal pain: a stigmatizing investigation to take with many a grain of salt” by Marco Monticone and the reply by O’Connell and his colleagues].

The paper has been cited 98 times, according to Clarivate’s Web of Science.

On August 15, the journal Clinical Rehabilitation pulled three additional studies by Monticone:

• “Task-oriented exercises and early full weight-bearing contribute to improving disability after total hip replacement: a randomized controlled trial.”
• “How balance task-specific training contributes to improving physical function in older subjects undergoing rehabilitation following hip fracture: a randomized controlled trial.”
• “Regent Suit’ training improves recovery of motor and daily living activities in subjects with subacute stroke: a randomized controlled trial.”

The papers have been cited a total of 79 times, according to Clarivate’s Web of Science. The notices included identical statements:

Sage and Clinical Rehabilitation were contacted by a reader who stated concerns about the authenticity of the data presented in these studies. In a recent publication [by Mark J. Bolland of the University of Auckland in New Zealand and colleagues], evidence was presented that successful randomization may not have occurred in the aforementioned studies. The reader stated that along with their concerns, another publication [by O’Connell and colleagues] has also noted irregularities in these trial results.

The authors provided their raw, underlying data when Sage contacted them for comment. The Journal Editors believe that the core questions on the authenticity of the data from these publications have not been fully addressed and resolved.

Due to the unresolved questions about the authenticity of the data the Editors retract these articles.

M.M., E.A., and S.F. disagree with the retraction decision. All other authors did not respond to this notice. 

We asked Avril Drummond, editor-in-chief of Clinical Rehabilitation, to elaborate on the concerns mentioned in the notices and the “unresolved questions,” but she had not replied by press time. (We also pointed out that, contrary to what the notice stated, O’Connell’s critique did not include the studies retracted in August.)

Bolland and colleagues, whose work the notice cited, examined data with known or suspected integrity issues, including 17 RCTs by Monticone’s group. Describing Monticone’s research, their paper stated:

[T]he differences between trial groups were smaller than expected. Again, there were about twice as many variables as expected that only differed by one or two participants between groups, and far fewer variables than expected that differed by four or more participants between groups. Again, the overall observed distribution was markedly different from the expected distribution (P=1.5*10⁹).

Monticone did not respond to emails seeking comment.

Meanwhile, several of the studies flagged by O’Connell’s group in 2022 remain in print, as his team pointed out last year in a letter to the editor titled “Effective quality control in the medical literature: investigation and retraction vs inaction.”

“Our team’s view is best captured by Amanda Williams in that paper,” O’Connell told us, referring to a passage that stated:

What have we learned? … while error and fraud are acknowledged as widespread, some editors appear disinclined to believe that their journals are affected; and that whistleblowers may still need to pursue concerns that are editors’ responsibilities.

We contacted the editors-in-chief and publishers of two of the journals in which these papers appear, the European Spine Journal and the European Journal of Pain. A spokesperson for Springer Nature, which publishes the European Spine Journal, told us:

We can confirm that we are aware of concerns with these papers and are carefully investigating the matter in line with our usual processes. We would be happy to provide an update once further information is available.

A spokesperson for Wiley, which publishes the European Journal of Pain, said: “We are investigating these concerns in accordance with COPE guidelines.”

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