Rapid Responses to:
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Rapid Responses: Rapid Responses published:
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What do "Symptoms" tell us
- Matthias Miesch (29 March 1999)
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Measuring additional drug use
- John Taylor (29 April 1999)
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Author's response: Measuring additional drug use
- N J Talley (1 June 1999)
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Author's response: What do "Symptoms" tell us
- N J Talley (1 June 1999)
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Value of contacting editors for papers in press: experience of systematic review of dyspepsia
- Brendan Delaney, David Forman (13 October 1999)
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Response from BMJ editor
- Richard Smith (13 October 1999)
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Matthias Miesch, SHO in Psychiatry Hairmyres Hospital, Scotland
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This study showed us that eradication of H. pylori does not relieve the symptoms of functional dyspepsia 12 months after treatment. The study did not look at psychological factors, like anxiety, depression, stress, somatisation or habits (alcohol, coffee, nicotine abuse) of the patients, which can all cause functional dyspepsia. I know that is was not part of the design of the study to look at the above named issues, but I think it should have been mentioned in the discussion. Even if we are all becoming more and more specialized we shouldn't forget "mind, body and soul", when we are treating our patients on a day to day bases. Our patients deserve a broad approach. Thank you very much. |
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John Taylor, 3rd year medical student Department of Epidemiology and Public Health, University of Newcastle-upon-Tyne
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Editor- The study by Talley et al demonstrated no convincing evidence that the eradication of H.pylori relieved the symptoms of functional dyspepsia 12 months after treatment. Whilst we found the results interesting, we would like to address and seek clarification on the following issues: The authors considered those patients taking gastro-intestinal drugs other than antacids within two weeks of the 12 month assessment to be treatment failures. However, drug usage prior to this two week period, although difficult to monitor, may confound the observations and conceal any effect of treatment. Secondly, the authors did not provide any baseline gastritis scores and thus the influence of intervention upon gastritis could not be determined. In addition, at the 12 month follow up, there were 127 patients with no or mild gastritis, compared to 123 patients with moderate or severe gastritis, a cumulative total of 250 patients. However only 195 patients made up the final analysis group. Clearly there is a discrepancy between these two figures, which although partially explained by the authors (inclusion of some patient gastritis scores from endoscopy findings at 3 months post intervention), there is still ambiguity over the origin of these 250 patients. John Taylor, Peter Watson, Paul Davies |
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N J Talley, Professor University of Sydney
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Thank you for the comments. We agree that medication use could be a confounder in non-ulcer dyspepsia trials, which is why we monitored the use of medications carefully in the trial. Medication use, however, did not appear to explain the outcomes in our analyses. The numbers are correct in the paper. You appear to be referring to the 195 patients in the per protocol analysis whereas our primary analysis was performed in the intention-to-treat cohort. Nicholas J. Talley |
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N J Talley, Professor University of Sydney
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Thank you for the comments. I agree that optimal patient management should include reassurance, explanation and exploration of psychological distress (which drives many of these patients to consult). However, it remains very unclear whether psychological factors are causally linked to non-ulcer dyspepsia, and this remains a fruitful albeit difficult research area. In a randomised trial hopefully psychological factors will be similarly distributed in the active and placebo arms and hence will not have confounded the results. Nicholas J. Talley |
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Brendan Delaney, Senior lecturer, Professor , David Forman
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Earlier this year we wrote to the editors of 28 specialist gastrointestinal, general medical and primary care journals worldwide, asking whether they could help us in obtaining relevant and up-to-date material for a systematic review of the management of dyspepsia which we are preparing for the UK National Health Technology Assessment Programme. [1] We were aware that there is a delay, often up to six months, between the acceptance of a manuscript and its subsequent publication. We asked if it would be possible for editors to tell us about any "in press" papers regarding the management of dyspepsia. If the material was of relevance then we planned to ask the authors and the journal for permission to use it in our review. In any case, the publication date for our review would be likely to be after any primary data had been published. Nine editors replied. Two anonymised abstracts, and the title of one paper to be published the next month, were sent. One editor had two papers in press but wished to contact the authors before releasing details. Six editors wrote to say they had no relevant papers in press. Several editors were concerned with confidentiality and workload, indicating that they would have to contact authors before releasing any information. The poor response to this approach may indicate that most editors are unwilling to undertake the work of contacting authors to preserve confidentiality. A number of the replies indicated that the journals concerned would be interested in exploring ways of notifying reviewers of papers in press. The recent announcement of the BMJ's plans to anticipate any development by the NIH of a biomedical e-print server by developing their own, [2] may go some of the way to meet the needs of those conducting systematic reviews and other researchers to keep up with fast-moving fields. However, not all papers will travel this route, and we were particularly concerned with papers that had been peer reviewed and were awaiting publication, rather than un-reviewed pre-prints. Conducting and maintaining up-to-date systematic reviews lies at the heart of the Cochrane Collaboration.[3] Knowing that an important study was just about to be published might influence contributors to the Cochrane Collaboration and other systematic reviewers in the timing of their reviews. Although formal and informal trials networks, research registers and the publication of abstracts all aid this process, information from journals would be a useful adjunct. One way around this would be to draw together the separate initiatives around registers of clinical trials, [4] e-print servers and electronic publishing. If authors and funding bodies are to be genuinely open in the conduct and dissemination of research, the publication of trial protocols, full disclosure of results, pre-publication open peer review, publication, discussion and synthesis with other relevant trials is all part of the same continuum. Research by Ida Sim and colleagues, presented at last year's Cochrane Colloquium [5] has established a format that could be used for such 'Trial banks', a demonstration of which is available on the web. [6] This is clearly a major undertaking. However, if the interested parties within each field could work together towards this aim, not an impossible task. 1. HTA project 96/37/01 www.hta.nhsweb.nhs.uk/ 2. Moving beyond journals: the future arrives with a crash [Editorial] BMJ 1999;318:1637-1639 ( 19 June ) 3. http://hiru.mcmaster.ca/COCHRANE/DEFAULT.HTM 4. www.update-software.com/nrronline/NRROpen.htm 5. http://rctbank.ucsf.edu:8000/home/dissertation.pdf 6. http://rctbank.ucsf.edu:8000/Presenter/ Dr Brendan Delaney Professor David Forman |
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Richard Smith, Editor, BMJ
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I was one of the editors contacted by Dr Delaney and Professor Forman, and I responded to them in the following way. "You raise an important but rather difficult question. I can see the sense of including in systematic reviews material that is in the pipeline for publication, particularly when many specialist journals take more than a year to publish. But there are thousands of journals, and clearly if you were going to conduct such a process systematically then you would need to write to every single one that might possibly have material in the pipeline on dyspepsia. This would be a formidable task. "It would be a formidable task not only for you but also for the editorial teams you approached. Firstly, we don't have any very systematic way of recording the content of papers in our system. We thus couldn't confidently tell you that we had identified every paper on dyspepsia. Secondly, we would not give you the names of authors without getting their permission first. We would want do to this because we regard ourselves as being in a confidential relationship with authors rather like the one that doctors have with patients. This would create more work for us. "The next question is where do we draw the line with which papers we might notify you about. We receive some 5000 papers a year and publish only 15%. Should we let you know about papers on dyspepsia that we've rejected, ones that we are currently considering, or only ones that are in the pipeline to publication? It seems to me that ideally you would want to know about all of them. "Another problem is that really every author doing a sytematic review should do something similar, making the whole process completely unmanageable. "Although I'm sounding defeated, I do see a way through. I think that we will soon have eprints in medicine, whereby people will post their studies on a website the minute they are completed. You should then be able to find them with comparative ease." Richard Smith |
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