Trial registration 10 years on
BMJ 2015; 351 doi: https://doi.org/10.1136/bmj.h3572 (Published 06 July 2015) Cite this as: BMJ 2015;351:h3572
All rapid responses
Rapid responses are electronic comments to the editor. They enable our users to debate issues raised in articles published on bmj.com. A rapid response is first posted online. If you need the URL (web address) of an individual response, simply click on the response headline and copy the URL from the browser window. A proportion of responses will, after editing, be published online and in the print journal as letters, which are indexed in PubMed. Rapid responses are not indexed in PubMed and they are not journal articles. The BMJ reserves the right to remove responses which are being wilfully misrepresented as published articles or when it is brought to our attention that a response spreads misinformation.
From March 2022, the word limit for rapid responses will be 600 words not including references and author details. We will no longer post responses that exceed this limit.
The word limit for letters selected from posted responses remains 300 words.
Dear Editor,
I really fear if it’s only me who feels a bit different about the so called laid down policies for publication and research. What if a doctor is posted at a really remote place, where a doctor may feel handicapped with the available knowledge, and the availability of resources? What, for instance, must a doctor do in case he or she happens to try out whatever he or she can to help a patient who has taken all the risks and trouble to reach out to a doctor in the remote wilderness? While serving with the Indian Army as one of its doctors, and posted to far-flung remote border areas where there were no roads or tracks in a high altitude mountainous region, at times I had found it very difficult to evacuate a patient to the next medical centre which had better medical facilities and availability of specialists. It was in such instances, and not wanting any patient to succumb in my presence, that I followed my conscience and took a few extra steps in order to help my patients. These were not trials, and were not registered. To me these were my last calculated efforts at saving and helping my patients for whom I was directly responsible.
Many of those novel and accidental medical techniques of mine have already been showcased by me to an international audience at various international medical conferences, and which are now a part of your BMJ’s domain now, as ‘rapid responses’. After my premature and voluntary retirement seven years ago from the army, after having served for nearly 25 years, I have spent some of my spare time at the age of 53 years helping myself with some of my medical problems.
Now ‘Essential Hypertension’ had been one of the many nagging problems I had, that had continuously glared at me, and at my incapacity to deal with it. Now that I have overcome this medical problem as well, and possibly for good, I would like the medical fraternity to hear and learn about it from me (before I die and take away the innovative technique with me). There have been many people thereafter who insisted and prevailed on me, and many of them now have their blood pressures settled within the normal range and are off anti-hypertensive drugs. I believe that there would be thousands who would have come across with some real breakthroughs, but would have been unable to disclose the same to the world. Possibly here lies the story of missed opportunities due to the policies that we have. Possibly the world needs to give a fresh thought to such accidental and novel innovations, that could be very useful to the whole world. Surely, with all the resources that the world has, the global medical and scientific fraternity could help improve these innovations further.
I also feel that the world community must spare some acknowledgement and encouragement as well to such people who have come up with innovations, as people like me may not feel up to it, and may not like to fill in the nomination forms for various awards and nominations, including the one that is being organized by you, The BMJ. The world must do it for them to encourage them and keep them motivated and going. Don't let them sulk or feel neglected anymore, please.
Best regards.
Competing interests: To date, there are more than a dozen patients who are not taking anti-hypertensive medication anymore, which they otherwise used to take regularly for past so many years. I happened to strike an accidental discovery that enabled settling down of blood pressure to within normal range. This elderly patient was a distant relative who had come all the way a very .ong way for treatment. He had been suffering from a very rare syndrome that affected his blood pressure as well, which was way beyond the accepted limits despite regular intake of anti-hypertensive medicines. This case was published as an e-letter to Editor in the Canadian Medical Association Journal (CMAJ) on 28 May 2014 (http://www.cmaj.ca/content/186/8/E281/reply). Ever since then my other relatives, family members and close friends became aware of this unintentional and accidental technique, and I was unable to refuse some of them who wanted their hypertension should be taken care of by this accidental technique. Yes, during my service days and now after my retirement some seven years ago, I have been experimenting on my body, and have accidentally developed a few novel and innovative techniques, that I had presented at various international medical conferences. All these 16 novel techniques have been summarized in a book that I was invited to write by an international publisher last year. This book is titled, "Innovative medical techniques showcased at international conferences", and much of it is also published as 'rapid responses' in your BMJ over the last few years. With no resources at my disposal, and with my own pension, and with no help, encouragement, or acknowledgment, I could not pursue these techniques any further, but have always wanted that the global community and the medical fraternity picks up from hereon. It would help if the continuous need of antihypertensive treatment is done away with, even in a small percentage of patients, with my technique. Surely this technique, and all the other sixteen techniques that have been showcased to the international fraternity, can be improved by world's scientists and the medical fraternity, and I would love to see my techniques helping the world. Now that is my competing interest.
Study registration 10 years forward: a perspective on observational research
Dear Sir,
We read with interest the editorial by Weber and colleagues [1]. Clinical trial registration provides centralisation of methodological quality assurance to all healthcare stakeholders. The pre-publication of trial protocols minimises post-hoc statistical manipulation and subsequent reporting bias. Interventional study registration has now therefore become a requirement for publication in most prominent scientific journals [2]. Across other study types, pre-registration of study protocols is also emerging as standard of practice. For example, a recent British Medical Journal (BMJ) publication outlined the 17-item ‘PRISMA-P’ checklist for protocol-driven systematic review and meta-analysis [3]. However, the mandate for pre-publication of a study protocol is yet to descend upon observational study types.
Observational studies represent 90% of published research, influencing clinical decision-making where published clinical trial data is lacking [4]. The STrengthening the Reporting of OBservational studies in Epidemiology group (STROBE, www.strobe-statement.org/) have identified protocol registration as one of the key steps in improving quality of observational studies and reducing the selective reporting bias [5]. It has been suggested that a priori definition of a primary endpoint and statistical analysis strategy would significantly improve the quality of evidence generated from these studies, with impact on grouped analyses [6, 7]. Whilst it is possible to publish protocols for observational research on registries such as ClinicalTrials.gov, this is infrequent, with only 17% of studies registered here being of observational design [8].
Some journals have pioneered mandatory protocol registration for observational studies (e.g. the Lancet). However many, including the BMJ are yet to follow suit (e.g. The Journal of the American Medical Association, Annals of Surgery and the British Journal of Surgery). We encourage authors to preregister study protocols for observational research, and for journal editors to require this. This is particularly important in surgery, where observational studies predominate, and risk of bias is high [6].
John Manley, James Lloyd, James C Glasbey*
University Hospital of Wales, Cardiff, UK
*jamesglasbey@gmail.com
Acknowledgments: With thanks to the Cardiff University Research Society (CuRES) - Short Duration Project Scheme (http://cures.cardiff.ac.uk/)
References:
[1] Weber WE, Merino JG, Loder E. Trial registration 10 years on. BMJ. 2015 Jul 6;351:h3572. doi: 10.1136/bmj.h3572.
[2] Zarin DA, Tse T. Medicine. Moving toward transparency of clinical trials. Science. 2008;319(5868):1340-2.
[3] Shamseer L, Moher D, Clarke M, Ghersi D, Liberati A, Petticrew M, et al. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015: elaboration and explanation. BMJ. 2015;349:g7647.
[4] Boccia S. Credibility of observational studies: why public health researchers should care? Eur J Public Health. 2015.
[5] Peat G, Riley RD, Croft P, Morley KI, Kyzas PA, Moons KG, et al. Improving the transparency of prognosis research: the role of reporting, data sharing, registration, and protocols. PLoS Med. 2014;11(7):e1001671.
[6] The PLOS Medicine Editors (2014) Observational Studies: Getting Clear about Transparency. PLoS Med 11(8): e1001711.
[7] Wu R, Glen P, Ramsay T, Martel G. Reporting quality of statistical methods in surgical observational studies: protocol for systematic review. Syst Rev. 2014;3:70.
[8] Williams RJ, Tse T, Harlan WR, Zarin DA. Registration of observational studies: is it time? CMAJ. 2010;182(15):1638-42.
Competing interests: No competing interests