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Recent eLetters

Displaying 1-10 letters out of 491 published

  1. The need to attend to outcome reporting bias

    I am the author of the NEJM article cited as reference #17, in which we showed stark differences in antidepressant efficacy according to two data sources-published journal articles and FDA reviews. The authors of this BMJ Open protocol list a number of sources they plan to search. What is not clear is how what they plan to do when faced with results of the same clinical trial from two (or more) sources. In our NEJM article, we found 11 trials which were positive according to journal articles but negative according to the FDA. When one considers that those journal articles were authored by those with a conflict of interest, and that the discrepancies were due to post hoc outcome switching, it seems clear that FDA reviews should be prioritized as the more credible data source.

    Conflict of Interest:

    None declared

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  2. Re:Statins do prevent heart attacks and strokes in the elderly

    One of Daniel Kellers arguments is right; association is not the same as causation. However, an inverse association is one of the strongest arguments against causation. Furthermore, we have not written that statin treatment is useless, but that its effect is minuscule. Keller has used a meta-analysis of statin trials in old people as an argument, but to claim that the risk of myocardial infarction was lowered by 39.4% and stroke by 23% is seriously misleading, because the absolute risk reduction was only 1.2% and 0.7%, respectively, and in accordance with our findings neither total or cardiovascular mortality was lowered.

    Conflict of Interest:

    None declared

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  3. Re:Re: Are depression and poor sexual health neglected comorbidities? Evidence from a population sample

    We thank Mr Islam for his interest in our study investigating the associations between depression and sexual behaviour, sexual function, and sexual health service use, using data from Britain's third National Survey of Sexual Attitudes and Lifestyles (Natsal-3), a probability sample survey of over 15,000 participants aged 16-74 years old.(1) We would like to draw attention to the open access methodology publications that underpin the study, including a two-volume technical report and a peer-reviewed methodology paper, as cited in our paper,(2,3) as these provide comprehensive methodological details about the study and statistical analyses and address a number of the points that he raises.

    In response to the specific methodological query as to why we only adjusted for age in our multivariable analyses: as in previous Natsal publications (see www.natsal.ac.uk), our rationale was guided by a priori consideration of variables likely to be confounders. While we explored adjusting for other variables (including partnership status), doing so made little or no difference to the patterns or strength of associations observed when we adjusted for age alone.

    Given two different depression outcomes, with different time periods, there were obviously several options for grouping participants in our study, and our approach selected groups that we judged to be readily identifiable in a clinical setting. We refer to Figure 1 in the paper, showing that around one in three men and women in the treated group had depressive symptoms, which may clear up some misunderstanding by Mr Islam about the allocation of individuals to the different groups. It would be overly simplistic to assume individuals reporting treatment for depression but not scoring highly on the PHQ-2 were 'cured', and combining these groups would complicate interpretation. We believe that our approach adds value by showing that there are individuals in the population reporting depressive symptoms but who have not been treated recently for depression, and that this group has similar sexual health characteristics to those recently treated for depression.

    Importantly, our work does not aim to demonstrate causality, which cannot be established by a cross-sectional study. Instead, the stated objective of our paper is to consider how depression is associated with reporting key sexual behaviours and sexual health outcomes, for which it is well-established that there are differences in men and women,(4) and different 'sexual scripts' that shape these behaviours.(5) As in other Natsal analyses, we stratified by sex, which is a potential effect modifier, and present all analyses separately for men and women, which also reflects observed differences in the prevalence of depression.

    Finally, Mr Islam was concerned about the age-range of participants included in the analysis, which draws attention to a strength of our study. In Natsal-3, around 60% of men and over 40% of women aged 65-74 years old reported at least one sexual partner in the past year,(4) which highlights the relevance of including older people when considering associations with a chronic health condition such as depression, which is common in older age.

    References

    1. Field, N. et al. Are depression and poor sexual health neglected comorbidities? Evidence from a population sample. BMJ Open 6, e010521 (2016).

    2. Erens, B. et al. Methodology of the third British National Survey of Sexual Attitudes and Lifestyles (Natsal-3). Sex. Transm. Infect. 90, 84 -89 (2014).

    3. Erens, B., Phelps, A. & Clifton, S. The third National Survey of Sexual Attitudes and Lifestyles (Natsal-3): Technical report. National Centre for Social Research, 2013. (2013).

    4. Mercer, C. H. et al. Changes in sexual attitudes and lifestyles in Britain through the life course and over time: findings from the National Surveys of Sexual Attitudes and Lifestyles (Natsal). Lancet Lond. Engl. 382, 1781-1794 (2013).

    5. Simon, W. & Gagnon, J. H. Sexual scripts: permanence and change. Arch. Sex. Behav. 15, 97-120 (1986).

    Conflict of Interest:

    None declared

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  4. Statins do prevent heart attacks and strokes in the elderly

    Ravnskov and colleagues conclude that their analysis of observational data requires "re-evaluation of guidelines recommending pharmacological reduction of LDL-C in the elderly as a component of cardiovascular disease prevention strategies." [1] I disagree, because the guidelines they challenge were based on large, randomized, placebo-controlled, double-blinded prospective interventional trials, higher-quality studies yielding more convincing data than the observational studies examined by Ravnskov. Statisticians warn us that observational data can only demonstrate associations, not causality, and should only be used for hypothesis generation, not for treatment decisions. [2]

    A meta-analysis of eight high-quality trials, including over 24,000 subjects with average age 73 years, was performed by Savarese and colleagues in 2013, which proved that elderly patients with CV risk factors but without established cardiovascular (CV) disease actually do benefit from statin therapy. [3] Statin therapy significantly reduced heart attacks by over 39%, and reduced strokes by over 23%, and non-significantly reduced all-cause mortality by 5.9%, and CV mortality by 9.3%. Mortality trends did not reach significance likely due to early termination of studies, required by the significant reductions in non-fatal CV events, among other reasons.

    Elderly patients with CV risk factors do benefit from pharmacologic reduction of LDL-C, and they should not discontinue statin therapy on the basis of this study alone. This study is based on observational data, of inferior quality to the data on which the treatment guidelines are based.

    References

    1. Ravnskov U, et al. Lack of an association or an inverse association between low-density-lipoprotein cholesterol and mortality in the elderly: a systematic review. BMJ Open, 2016 Jun 12;6(6):e010401.

    2. Hannan EL. Randomized clinical trials and observational studies: guidelines for assessing respective strengths and limitations. JACC Cardiovasc Interv, 2008 Jun;1(3):211-7.

    3. Savarese G, et al. Benefits of statins in elderly subjects without established cardiovascular disease: a meta-analysis. J Am Coll Cardiol, 2013 Dec 3;62(22):2090-9.

    Conflict of Interest:

    None declared

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  5. Consumer concerns about paracetamol: a retrospective analysis of a medicines call centre

    The study," Consumer concerns about paracetamol: a retrospective analysis of a medicines call centre" conducted by Lau et al highlights the importance of dissemination of drug information to the general public which I found to be very interesting and informative. The use of both quantitative and narrative analysis allows one to appreciate not only the inadequate information and comparatively high usage of paracetamol but also the specific concerns expressed by the consumers. Most of the paracetamol calls were related to inadequate information at various stages of the life cycle: the child, the elderly, pregnancy and lactation. A significantly high proportion of the callers were also concerned about the safety of the drug. Even though this research was conducted in Australia, the findings concerning paracetamol could be very applicable to consumers in other territories where this product is sold. The findings would suggest that in general, the public is desirous of reliable, easily accessible and readily understood information. However, there is a gap between knowledge/information and its availability and usefulness to the consumer.

    Napoles (2011) underscores the importance of planned implementation of strategies for effective knowledge translation that would allow for movement through the action cycle (Graham, 2006) Whereas regulating OTC medications to prescription only drugs may be somewhat restrictive, I do support the notion of confining OTC drugs to only pharmacies where the controlled environment allows for close contact with the pharmacist and easier access to reliable information. I certainly endorse the standardization of patient information provided by the patient leaflets and I think this should be applied to all OTC medications. Drug companies should be mandated to provide basic relevant information for all OTC medications regardless of the country of distribution.

    References

    1. Graham ID1, Logan J, Harrison MB, Straus SE, Tetroe J, Caswell W, Robinson N. Lost in knowledge translation: time for a map? J Contin Educ Health Prof, 2006;26(1):13-24.

    2. Ann Maria Napoles, Jasmine Santoyo-Olsson, Anita Stewart. Methods of Translating Evidence-Based Behavioral Interventions for Health-Disparity Communities. Prev Chronic Dis, 2013;10:130133.

    Conflict of Interest:

    None declared

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  6. Re:Reply to: BMJ Open - Conflict of interest between professional medical societies and industry: a cross sectional study of Italian medical societies' websites

    We would like to thank Franco Vimercati and Francesco Macri for pointing out an imprecision in our paper with regard to the Law Decree approved by the Ministry of Health in 2004 and revoked by the Constitutional Court in 2006. We have already asked BMJ Open to publish an errata corrige which will be online soon.

    Moreover, since the aim of our paper is to stimulate a reflection on the relationship between medical societies and industry, we highly appreciate FISM readiness to share the work the Federation is doing on this issue.

    Conflict of Interest:

    None declared

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  7. Factors contributing to delay of cancer among Aboriginal People in Australia: a qualitative study

    Dear Editor, I am writing in reference to an article written by Shahid S, Teng T-HK, Bessarab, D, et al. "Factors contributing to delay of cancer among Aboriginal People in Australia: a qualitative study". BMJ Open 2016;6:e010909 doi:10.1136/bmjopen-2015-010909. What I found very interesting about this research is that the findings of this study revealed multi-factorial contributory issues that exist for this population. By using a qualitative design you were able to capture the context of the behavior and the experience that exist to better under their diagnostic delay among this population. The greater challenge moving forward, I believe, is to use knowledge translation to strength health systems through policy change etc. in order to improve the health of this population (Straus, Tetroe, & Graham, 2009) thereby closing the gap of the health disparity. I look forward prospective research on this population.

    Ingrid Gibson-Mobley Assistant Professor The College of The Bahamas

    Reference Straus, S. E., Tetroe, J., & Graham, I. (2009). Defining knowledge translation. CMAJ?: Canadian Medical Association Journal, 181(3-4), 165- 168. http://doi.org/10.1503/cmaj.081229

    Conflict of Interest:

    None declared

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  8. Gender Plays a role in Hypertension Prevalence

    Dear Editor

    I write in reference the article, Prevalence, awareness, treatment and control of hypertension in a self-selected Sub-Saharan African Urban Population: a cross-sectional study (2012). Although hypertension is a major health problem in the Caribbean findings of the article showed men to be at greater risk for the development of cardiovascular diseases. I would like to raise the point that women still have significant risk for hypertension and that the outcomes for women may be more severe given the inequities on roles and access to services that exist between men and women, particularly in low- and middle-income countries. According to the American Heart Association (2016), each year more women than men suffer and die from cardiovascular complications such as stroke. In my own work, I also found Bahamian women to be at greater risk than men for the development of complications due to hypertension and that their status in society was likely a contributing factor. Gender roles held by Caribbean women results in women bearing a greater burden in balancing careers, childbearing, and placing the needs of their family above their own. As a result, many women with hypertension may not access treatment until into the late stages of cardiovascular symptoms development. Additionally, women have other risk factors for hypertension that men don't, including the use of birth control pills, pregnancy, history of preeclampsia/eclampsia or gestational diabetes, oral contraceptive use, smoking, and post-menopausal hormone therapy. A stratified analysis of the risk factors by gender in the study by Dzudie and colleagues, therefore, would have been more informative, such that predictors for men and women would have been identified separately. Data such as this would provide greater insight into the predictive factors and aid in the advancement to prevent, better manage and reduce morbidity and mortality due to hypertension in both men and women of African Heritage living in low- and middle-income countries.

    Elizabeth J. Williams Assistant Professor The College of The Bahamas

    Conflict of Interest:

    None declared

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  9. Medical writing support plays an important role in raising the quality of clinical trial reporting

    We thank Tom Lang for his interest in our paper (Professional medical writing support and the quality of randomised controlled trial reporting: a cross-sectional study) [1,2]. We are pleased that Mr Lang agrees with us on the need for serious research into the value of medical writing. Our study used robust methodology to address exactly that. We applied independent and well-accepted measures to assess the quality of reporting (CONSORT adherence and peer-reviewer assessment) in all eligible articles with declared medical writing support (and control articles without such support) in the first and largest open-access journal publisher. We believe that our study provides the best available evidence of the value of declared medical writing support, by showing how it improves both the completeness and quality of reporting of medical research.

    On the basis of his experience, Mr Lang states that medical writing is most often provided by in-house medical writers employed by the sponsor company. In our study, however, affiliation of writing support to the sponsor company alone was acknowledged in only 20% of cases (22/110 articles). The majority of articles acknowledged medical writers from an external communications agency (52.7%, 58/110 articles). In a small number of articles, acknowledgement was to medical writers from both an agency and the sponsor (4.5%, 5/110 articles) or to a freelance medical writer (5.5%, 6/110); the affiliation of the medical writer was not stated in 17.3% of cases (19/110 articles). Our data show that the proportion of completely reported CONSORT items was similar in the 22 articles with only in-house medical writing support (43.8% of items) and the 88 articles written with the involvement of publication professionals with other affiliations (42.1% of items).

    Mr Lang also argues that the improved quality of reporting seen in articles prepared with medical writing support may result from the involvement of the sponsors of such support, rather than the medical writers themselves. However, among articles without medical writing support, industry-funded articles were no more likely to report at least 50% of studied CONSORT items completely than non- or part-industry-funded articles (17.9% vs 22.6%, p = not significant) [3]. Furthermore, among industry-funded articles, those with acknowledged medical writer support were more likely to report at least 50% of studied items completely than those without such support (38.0% vs 17.9%, p < 0.05). Taken together, our results are consistent with the idea that it is medical writing support rather than industry involvement that improves the quality of reporting.

    CONSORT is the longest established and most widely accepted reporting guideline [4], and one of us was an author of the most recent update [5]. Arguably, not all CONSORT criteria are equally important. Medical writing support was associated with marked improvements in reporting of clearly important criteria such as specification of the primary outcome and sample size calculation, and inclusion of a participant flow diagram and details of trial registration (all reported in over 50% of articles with medical writing support). In fact, a participant flow diagram was included in 65% of articles with medical writing support and 33% of those without such support, rather than the 40% and 32% calculated by Mr Lang.

    Mr Lang argues that, because articles without medical writing support were smaller on average than those with such support, they may be less likely to report a sample size calculation, method of stratification and so on, for the simple reason that a sample size calculation and stratification are less likely to have been conducted for small studies. We agree that this is a possibility worth excluding. We have taken the median number of patients in studies written up without medical writing support (n = 43) to be the upper limit for a study to be considered small. Then, focusing solely on these small studies, we have found that the proportion of articles reporting at least 50% of items completely was 21.7% (n = 23) for articles with medical writing support compared with 6.5% (n = 62) for articles without such support. Thus, with the caveat that post hoc analyses must be interpreted with caution, involvement of professional medical writing support is still associated with a higher percentage of complete reporting in small studies.

    As Mr Lang points out, there is room for improvement in compliance with CONSORT criteria, even in articles prepared with medical writing support. Therefore, it is encouraging that, as shown in the supplementary material to our original article (http://bmjopen.bmj.com/content/suppl/2016/02/17/bmjopen-2015- 010329.DC1/bmjopen-2015-010329supp_figures.pdf), CONSORT adherence in articles with medical writing support appears to be increasing. We believe that education and training provided by bodies such as the International Society for Medical Publication Professionals (ISMPP), the European Medical Writers Association (EMWA), the American Medical Writers Association (AMWA) and the EQUATOR Network, and by individual medical communications agencies and journals [6] will improve the standards of reporting further, to the benefit of researchers, clinicians and, ultimately, patients.

    We conclude that medical writing support plays an important role in raising the quality of clinical trial reporting. As with any observational study, causality cannot be definitively established, but there are good reasons to believe that professional medical writing support has an important role to play in improving the quality of reporting of randomized clinical trials.

    References

    1. Gattrell WT, Hopewell S, Young K, et al. Professional medical writing support and the quality of randomised controlled trial reporting: a cross-sectional study. BMJ Open 2016;6:e010329. doi:10.1136/bmjopen-2015 -010329.

    2. Lang T. Response to Gattrell et al. Professional medical writing support and the quality of randomised controlled trial reporting: a cross- sectional study. BMJ Open 2016; 1 April.

    3. Gattrell W, Hopewell S, Young K, et al. Professional medical writing support improves the quality of reporting of randomized controlled trials. Curr Med Res Opin 2015;31(S9):S20 [poster 36]. Presented at the 11th Annual Meeting of the International Society for Medical Publication Professionals, 27-29 April 2015. Available from: http://www.eposters2u.com/349587 (Accessed 29 April 2015).

    4. Altman DG, Simera I. A history of the evolution of guidelines for reporting medical research: the long road to the EQUATOR Network. JLL Bulletin: Commentaries on the history of treatment evaluation 2015. Available from: http://www.jameslindlibrary.org/articles/a-history-of-the- evolution-of-guidelines-for-reporting-medical-research-the-long-road-to- the-equator-network/ (Accessed 25 May 2016).

    5. Schulz KF, Altman DG, Moher D, for the CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c332.

    6. Turner L, Shamseer L, Altman DG, et al. Does use of the CONSORT Statement impact the completeness of reporting of randomised controlled trials published in medical journals? A Cochrane review. Systematic Reviews 2012;1:60. doi:10.1186/2046-4053-1-60.

    Conflict of Interest:

    Competing interests: PF, RW and CCW are medical communication professionals employed by Oxford PharmaGenesis. WTG and KY are former employees of Oxford PharmaGenesis. PF, RW and CCW are shareholders of Oxford PharmaGenesis. CCW holds shares in AstraZeneca and Shire Pharmaceuticals. SH is a member of the CONSORT group. EW is the owner of Sideview, which provides training and consultancy in medical writing, and has previously worked as a medical writer.

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  10. Re: Association between employment status change and depression in Korean adults

    Response to the article titled: Association between employment status change and depression in Korean adults. March 1, 2016

    This study sought to determine the effects of employment status on the mental health, specifically depression, of Korean adults who were permanently employed, precariously employed and unemployed. It was a 5 year longitudinal study which used data collected from the Korean Welfare Panel Study. The findings of the study showed that change in employment status from being permanently employed to precariously employed or unemployed increased the risk of depressive symptoms especially in men and women who are head of households.

    I found the study very relevant and I appreciated the comparisons made between the various changes in employment status (i.e. permanent employment to precarious employment or permanent employment to unemployment) and depression. I particularly liked that sub group analyses by gender and head of household were conducted. I would be really interested in seeing a similar study done in my own country, Jamaica, where mental illness remains understudied and female-headed households account for almost half of all households. I believe that this study adds to the knowledge base, and it is an important area to study, although as mentioned in the article is not the first of its kind.

    Depression has been highlighted as a common disorder globally and is the leading cause of disability in terms of total years lost due to disability. It is also noted that this illness presents a public health issue which will affect the socio-economics of a country (WHO, 2012). As such I felt that the article may have been strengthened if the authors had gone further in the discussion to examine the implications that may arise if the problem of negative changes in employment status is not dealt with. The article mentions that policymakers should consider gender and head of household status for creating welfare policies; but what about considering the overall impact of the problem on the society.

    Reference

    Marcus, M., Yasamy, M. T., van Ommeren, M., Chisholm, D., & Saxena, S. (2012). Depression: A Global Public Health Concern. WHO department of Mental Health and Substance Abuse

    Shatha Richards (Miss) Email: ahtahs.richards@gmail.com

    Conflict of Interest:

    None declared

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