709 e-Letters

  • The Importance of Methodological Rigor and Communication of Information

    Dr. Mamluk and colleagues’ recent systematic review and publication in BMJ Open (1) carries with it a provocative title and over the past week its conclusions have garnered substantial attention by news organizations such as CNN (2), Newsweek (3), and the New York Post (4). Although we agree completely with the authors’ assertion that there is a significant gap in the literature concerning low levels of maternal alcohol consumption during pregnancy, we have some substantial concerns regarding misleading statements in the paper and inconsistencies between the methodology that was stated versus that which was conducted.

    First, in the introduction, the authors claim that “Internationally, clinical guidelines recommend that pregnant women should abstain from heavy or ‘binge’ drinking”. Although technically correct, it is misleading since the messaging reported in the authors’ cited reference actually shows that nearly every country advises abstaining from any alcohol consumption during pregnancy – not just heavy or binge drinking. Furthermore, the authors state that “…UK guidelines advised women to avoid drinking alcohol while trying to conceive, and in the first trimester, but at the same time indicated that consumption should be restricted to within ‘1 to 2 UK units, one or twice a week.” Their statement makes it seem as though the UK message is contradictory regarding maternal alcohol consumption during pregnancy – it is not. In the 2016 UK Chief Medical Officers’ Lo...

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  • Comments on PROMISE data interpretation in Siemieniuk meta-analysis from PROMISE team

    To the BMJ Editor:

    A recent analysis in BMJ Open accompanied by a clinical practice guideline on antiretroviral therapy (ART) in pregnant women living with HIV by Siemieniuk et al has concluded that “tenofovir/emtricitabine is likely to increase stillbirth/early neonatal death and early premature delivery compared with zidovudine/lamivudine” (1,2). While the clinical practice guideline was based on a systematic review, in reality, the conclusion was based solely on results of the PROMISE study (3). Evidence from large observational studies did not support this recommendation, but was viewed as too low quality to consider in making recommendations. As coauthors of the PROMISE study, we would like to comment on the authors’ conclusion.

    The objective of the PROMISE trial was to compare the efficacy of zidovudine/single-dose nevirapine (AZT-alone) with protease inhibitor-based (lopinavir-ritonavir) combination ART (AZT-based ART [AZT-ART] or tenofovir-based ART [TDF-ART]) to prevent mother-to-child transmission in women with CD4 cell count >350 cells/mm3 (3).The study enrolled during two periods, and the comparisons of the TDF-ART arm to the other arms are restricted to the women who were concomitantly randomized among the three study arms, which occurred only in the second period of the study. In Period 1 – accounting for about two-thirds of enrollment - only hepatitis B virus (HBV)-coinfected women (~1% of overall enrollment) were randomized to TDF-ART vs...

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  • Challenges in reviewing methamphetamine-associated psychosis

    Stuart and colleagues protocol for a systematic review of psychological treatment for methamphetamine use [1] is a timely and relevant response to a significant gap in guidance for treatment of psychological sequelae arising from psychostimulant use. Given that levels of psychological distress and clinical mental health symptoms are very common in people who use methamphetamine, there is an urgent need for psychological treatment guidelines for this population.

    While many psychological interventions to date have also targeted comorbid anxiety and depressive symptoms, psychotic symptoms are also highly prevalent, clinically challenging and often poorly addressed. Methamphetamine-associated psychosis has been associated with significant morbidity, including increased agitation and violence, presentation to acute health services, and considerable health service burden [2]. A subset of individuals may also be at risk of developing more persistent psychotic symptoms, later transitioning to a diagnosis of chronic psychotic disorder.

    To date, the presence of psychotic symptoms has either been excluded, or not routinely screened for, in the majority of studies of psychological treatment for methamphetamine use. For instance, some studies have excluded participants with recent antipsychotic medication use[3], while measurement of psychotic symptoms or clinical assessments of psychotic disorder are typically absent [4-7]. On the other hand, many pharmacological inte...

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  • Liquor lobby cited (incorrectly) in article

    It is concerning to read on page 1 of the introduction that “Internationally, clinical guidelines recommend that pregnant women should abstain from heavy or ‘binge’ drinking'". The reference cites the liquor industry social aspects organisation [http://www.iard.org/] as their source, which we admit find rather unusual. What is more unfortunate is the authors then misrepresent the content found on the industry website. Rather than the guidelines recommending the avoidance of heavy drinking, all of the 54 countries’ guidelines for alcohol and pregnancy advise abstinence, and the only exception is Bulgaria which offers a low-risk level for pregnant women who do choose to consume. This appears contradictory to the statement made by the authors in their introduction.

  • The burden of respiratory infections in primary care – the missing piece of the puzzle?

    We would like to thank the authors for their informative and innovative research, which interrogated electronic medical record free text, to demonstrate the significant impact of childhood respiratory illness on primary care workload in New Zealand. The findings indicate that almost half (46%) of all child-general practitioner consultations between January 2008 and December 2013 were attributed to the management of respiratory conditions.

    The findings of this research are not surprising given that children in developed and developing countries report six to eight episodes of acute respiratory tract infection every year (1). The high rate of consultations may be partly explained by the fact that there is no cure for acute respiratory infections, only symptomatic relief (1). For some parents, this might necessitate frequent and repeat consultations with general practitioners.

    While this research sheds light on the role of general practitioners in the management of childhood respiratory illness, there continues to persist ongoing knowledge gaps in an equally important field. There is some evidence to indicate that many parents manage their child’s acute respiratory infections at home, using a range of therapies, including complementary and alternative medicines (CAM)(2). With the increasing popularity of CAM and emerging high level evidence to support the role of CAM therapies for acute respiratory tract infection (e.g. Sambucus nigra (3), Pelargonium sidoides...

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  • Response to Vibha Jaiswal, Barriers to real world deployment of HPV consultation guides by ENT surgeons

    On behalf of the authors: We thank Dr Jaiswal for her generous and supportive comments about our article, ‘Talking about human papillomavirus and cancer: development of consultation guides through lay and professional stakeholder coproduction using qualitative, quantitative and secondary data’. We are pleased that reading it prompted her to conduct a rapid assessment of our consultation guides.
    We were delighted to discover the close similarities between the comments expressed by the clinicians in our study and the doctors who took part in Dr Jaiswal’s assessment exercise, and gratified that they found the consultation guides useful and would give the information leaflets to their patients. That the number of doctors fairly or very confident discussing HPV in the context of a Head and Neck consultation rose from 56% to 100% is very encouraging. This further strengthens our confidence in these tools. We would be pleased to receive continuing feedback from clinicians on their use of the guides or the patient information leaflets.
    The main barriers to deployment of the consultation guides in the real world are the practical ones of dissemination and implementation. How can we inform the appropriate clinicians of their existence, and make these resources more easily accessible to them? At present they are available to download; we would like to see them produced as print versions that could be more readily to hand in a consultation. We also believe that the...

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  • Comment on statistics

    Poisson regression is unsuitable for analysing data from Likert scales, even in aggregate (see http://rcompanion.org/handbook/E_01.html).

    Summing enough Likert scales (as when summing enough random variables) might result in summary data which are suitable for least squares regression, via the central limit theorem. But, Poisson regression is suitable for count data where the variance is equal to the mean (count data that violate this equality may require negative binomial regression).

    Since the statistical analysis is inappropriate, the Results and Conclusions may be unsound.

    Multi-level IRT is probably an appropriate way to analyse multiple Likert scales (e.g. Luo & Wang, Stat Med. 2014 Oct 30; 33(24): 4279–4291)

  • Important issues for casualty trauma care and an ethical plea

    The authors accomplish to objectify the experiences of military surgeons collected in current military conflicts by this scientific study and manage to give practical guidelines for the treatment of the sustained injuries.

    Especially the significance of multiple amputations and perineal injuries as indicators of more severe injuries (e.g. pelvic fractures) due to a massive transfer of energy is highlighted. These patients are at a higher risk of exsanguination and infection. First important measures can be applied in the field by the attending medic: the liberal use of tourniquets and pelvic binders cannot be stressed enough. A finding that even has impact on the civilian sector. With an increase of terroristic attacks we can implement the knowledge which was won in military conflicts.

    Moreover we may not neglect the effects of these injuries onto the whole life of the patients which are mostly young men. A lot of subsequent problems have to be expected that represent major challenges for both the patients and the societies. Especially as a result of ageing many patients will compensate their lost limbs to a lesser extent over time.

    Beyond the medical findings this paper stands out especially because of its ethical assessment of AP-IED’s. It was utterly justified to outlaw the use of APM’s, in today’s conflicts APM’s only play a minor role. A similar process concerning the AP-IED’s is extremely desirable which even have more gruesome effects as shown...

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  • Amendment to the OPTIMUM Protocol

    To the editor

    We would like to notify readers of two amendments that have been made to the OPTIMUM trial protocol since its publication in the BMJ Open in October 2016. These have been approved by the Regional Ethics Committee (Brighton and Sussex - 15/LO/1018)

    1) Indwelling Pleural Catheter Pathway: On the day follow-up 4 for the indwelling pleural catheter group, the criteria of <150ml/day fluid output to administer talc has been removed as complete drainage on day 1 may be limited due to symptoms.

    2) Set up of international sites: For international sites (defined as outside of the UK), the trial pathway will remain the same. To ensure satisfactory trial conduct and accurate data capture, the OPTIMUM database will be contained on a web-based browser-accessible database. This password protected, secure database service will only be accessible to the trial team at GSTT as well as the satellite international sites.

    User policies (with unique logins) will be implemented to prevent unauthorised data manipulation and access to data outside of the institutions recruited and a full GCP compliant audit trail will be used to monitor activity.

    Yours Sincerely

    Dr Parthipan Sivakumar & Dr Liju Ahmed

  • Thanks for your Comments related to International Humanitarian Law

    Thanks for your comments and I agree it is difficult to address Rule 70 in countries who do not subscribe to the conventions. However this does not negate the need for continued efforts to add AP-IEDs to the list of weapons that cause excessive injury or suffering that is disproportionate to the military advantage sought by their use, and only by only by documenting and publishing these injury patterns can we offer the necessary evidence. The data also suggests the indiscriminate nature of this weapon - in that children were part of the co-hort – and this also needed to be identified.