Three more retractions for former record-holder Boldt, maybe more to come

Justus Liebig University in Germany has been investigating concerns that Joachim Boldt, number two on the Retraction Watch Leaderboard and now up to 92 retractions, may have “manipulated” more data than previously believed. Until now, the vast majority of Boldt’s retractions were thought to have involved inadequate ethics approval. However, new retraction notices for Boldt’s […]

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Intent was there, but not the intention-to-treat analysis: Breast cancer study retracted

A group of Dutch researchers has retracted a paper they published in March after apparently learning that they’d bungled their statistical analysis in the study.

The article, “Effects of a pre-visit educational website on information recall and needs fulfilment in breast cancer genetic counselling, a randomized controlled trial,” was published in Breast Cancer Research by Akke Albada of the Netherlands Institute for Health Services Research and colleagues.

But according to the notice, Utrecht, we have a problem:

The authors would like to retract their article “Effects of a pre-visit educational website on information recall and needs fulfilment in breast cancer genetic counselling, a randomized controlled trial” [1]. After publication of this paper the co-authors noticed a discrepancy between the analyses as described (intention-to-treat analysis) and the analyses as performed (per-protocol analysis), leading to an overestimation of the intervention effects. Therefore the authors have decided to retract this paper in its current form.

Those results:

Intent-to-treat analysis showed that counselees in the intervention group (= 103) had higher levels of recall of information from the consultation (β = .32; confidence interval (CI): .04 to .60; P= .02; d = .17) and post-visit knowledge of breast cancer and heredity (β = .30; CI: .03 to .57; P= .03) than counselees in the UC group (= 94). Also, intervention group counselees reported better fulfilment of information needs (β = .31; CI: .03 to .60; = .03). The effects of the intervention were strongest for those counselees who did not receive an indication for DNA testing. Their recall scores showed a larger increase (β = .95; CI: .32 to 1.59; = .003; d = .30) and their anxiety levels dropped more in the intervention compared to the UC group (β = -.60; CI: -1.12 to -.09; = .02). No intervention effects were found after the first visit on risk perception alignment or perceived personal control.

So what, exactly, was their mistake? In a nutshell, an intention to treat analysis takes into account whether subjects in a trial have dropped out. If too many have, the results may skew in a particular direction, often that an intervention works better than it does. The intention to treat analysis tries to keep the statistics honest by assuming that the reason people dropped out was because they had a negative outcome.

Although these sorts of errors aren’t particularly common, they’re not unheard of. Indeed, we reported recently on a similar case involving a former Pfizer researcher. And one of us (Ivan) has pointed out the importance of such problems in print in the past. So it’s good to see authors taking responsibility in this case.


Anesthesia journal retracts paper from Estonian researchers in wake of legal inquiry

Acta Anaesthesiologica Scandinavica has retracted a 2008 paper by a group of Estonian researchers who appear to have wound up in legal jeopardy for misrepresenting their work.

Here’s the notice:

Retraction: The following article ‘Spinal 2-chloroprocaine: effective dose for ambulatory surgery’ by A. Sell, T. Tein and M. Pitkänen in Acta Anaesthesiologica Scandinavica 2008; 52: 695-699, and first published online on 15 April 2008 in Wiley Online Library (www.wileyonlinelibrary.com), has been retracted at the request of the Tartu University Hospital and the Estonian State Agency of Medicines by agreement with the journal Editor in Chief, Lars S Rasmussen and Blackwell Publishing Ltd. The retraction has been agreed following the conclusion of an investigation conducted by the Estonian legal authorities. The study was not approved as required according to Estonian law and the study design was misrepresented in the article.

The paper has been cited 11 times, according to Thomson Scientific’s Web of Knowledge.

The study is described as being a randomized controlled trial in which:

Sixty-four ASA physical status I-III patients undergoing elective lower limb surgery were randomly allocated to one of the four local anaesthetic groups for spinal anaesthesia in a double-blind manner. The patients (n=16 patients in each group) received 35, 40, 45 or 50 mg of 10 mg/ml isobaric 2-CP.

Rasmussen declined to discuss the nature of the problems with us, but he did confirm that Pitkänen was a member of his journal’s editorial board when the paper was published and still is.

We have tried to reach Pitkänen but haven’t heard back. We’ll update this post if we learn more.