664 e-Letters

  • Authors' reply to Steele et al.

    We thank Steele et al for their interest in the article. 1,2
    We agree that over ascertainment and treatment is a limitation of the currently available screening methods as they do not accurately identify which of the carriers will pass on the infection to the baby. But screening will, at least, ensure that IAP is given to most women who may pass on the infection to the baby. This is in contrast to risk based IAP where IAP is given to women who do not carry GBS and consequently cannot pass the infection to the baby. Furthermore, the potential to be effective is limited by the fact that an estimated 65% of the mothers of babies with EOGBS infection do not have risk factors. 3
    We wish to point out that we never set out to undertake a comparative trial. We implemented screening based IAP as a service improvement in response to rates of EOGBS reaching to 1.65/1000 live births in 2013, considerably higher than average for the UK. 3
    An analysis adjusting for confounding variables was not originally undertaken for three reasons. Firstly, the number of EOGBS cases was small, and thus may not be sufficient for a fully adjusted analysis. Additionally, the full patient level data was unavailable for all cases in the pre-screening period, meaning we were unable to perform an analysis with adjustments for more than one variable. Finally, whilst statistically significant due to the large sample size, differences in age and mode of birth are fairly negligible practical...

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  • Correction to cohort numbers

    On further analysis of the cohort data, two participants from one cohort from Kenya (EMEP) were found with implausible birth weights. It was not possible to discover the true birth weights, and so these women have been censored from ongoing analyses, decreasing the cohort from 14635 to 14633 deliveries. This does not affect the conclusions of the paper.

  • Gaps in the evidence base

    We are grateful to the authors of “Outcome of a screening programme for the prevention of neonatal invasive early-onset group B Streptococcus infection in a UK maternity unit:
    an observational study” for publishing the results of the screening programme for GBS carriage at Northwick Park Hospital.1 The impetus behind the programme was clearly driven by concern for the health of newborn babies and enthusiasm to reduce the rate of EOGBS in the hospital’s population.

    However, the national policy on culture based screening at 35-37 weeks gestation is that this should not be offered. In large part this is informed by concern about the screening test’s inability to reliably distinguish between women whose babies would be affected by EOGBS and those whose babies would not. The consequence of this is a high rate of overdiagnosis and subsequent overtreatment. The Northwick Park experience provides an insight into this which was not brought out in the paper.

    The paper reports an EOGBS rate of 0.99 / 1000 deliveries prior to screening and a GBS carriage rate of 29% in the population. With 9098 live births in the study period 9 cases of EOGBS in approximately 2600 carriers would be expected. Screening at 35 – 37 weeks aims to identify these carriers and offer IAP to reduce the risk of EOGBS. From what is presented in the paper regarding transmission rates, and elsewhere regarding test accuracy,2,3 between 60% and 80% of these carriers would be eligible for IAP wh...

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  • We're not as popular as we look! Explaining the high view numbers for this paper...

    Dear all readers,

    It's the authors here. We just wanted to add a note about the enthusiastic article metrics this paper has been generating. No doubt, of course, a number of these are genuine. However, the runaway popularity of the paper earlier this year was, we now know, driven by a badly behaved function on our university website: this function is supposed to collect related links for blog posts we carry, but was in fact looping incorrectly and triggering hits on the journal's website page for the paper. This fault - entirely non-malicious, we should stress - has now been corrected. Hopefully reading figures will go down to the levels of interest we might expect for those interested in inequalities in care for minority ethnic groups, and vignette methods. Apologies to the journal, and to readers, for this occurrence.

    Best wishes,

    Jenni Burt
    [on behalf of the authors]

  • Little evidence to support OPAT versus oral antibiotics

    Mitchell and colleagues make the point that OPAT has not realized its full potential in the UK because there is a paucity of evidence of effectiveness, associated risks and patient preferences for this form of treatment. However, there is another reason why OPAT is not used more and that is there is no evidence to support intravenous antibiotics versus oral antibiotics for a large proportion of the patients using OPAT services. OPAT is often used to treat skin infections such as cellulitis (1) for which the evidence supports short courses of oral antibiotics (2,3).
    Very few of the other indications for OPAT are supported by evidence of superiority over oral continuation therapy, as there are few clinical trials, and where evidence exists of comparison it is often from retrospective studies (4). MacGregor summarized the evidence, and the obstacles, 10 years ago (5).
    There are perverse incentives for the use of OPAT; payments to hospitals to provide OPAT as an alternative to inpatient IV therapy and thus an incentive to recommend IV therapy instead of oral. During a recently completed clinical trial we faced problems recruiting from hospitals that had OPAT services, as they would receive a lower payment if they prescribed oral flucloxacillin instead of IV ceftriaxone delivered via OPAT.
    The infectious diseases community need to provide us with good evidence that the IV antibiotic therapies being recommended have a sound evidence base. The present support fo...

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  • Authors' reply to Dr Sandeep Reddy

    Dear Dr Reddy

    Thank you for your letter expressing your “astonishment” at the title and methods of our paper “Cost and outcome of behavioural activation versus cognitive behavioural therapy for depression (COBRA): A qualitative process evaluation”, BMJ Open 2017;7:e014161. Whilst we welcome your comments, we respond by pointing to the Medical Research Council (MRC)’s guidelines for developing and evaluating complex interventions, which state that a process evaluation assists in: understanding how context influences outcome, identifying problems with implementation and providing insights to aid implementation, understanding how an intervention can be optimised, clarifying causal mechanisms, and identifying contextual factors associated with variation in outcomes.[1] In addition, the MRC’s subsequent guidance for the process evaluation of complex interventions recommends the use of qualitative methods to understand experiences of the intervention and unanticipated or complex causal pathways.[2]

    Whilst you are quite correct that our paper did not report the full process evaluation in the comprehensive manner you describe, our qualitative study did indeed provide insights, from patients’ perspectives, on personal, contextual and therapeutic factors that facilitated or hindered the therapeutic process, as well as reporting the mechanisms by which patients believed BA and CBT to have brought about positive change in symptoms of depression and other domains of life...

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  • Response to: Commentary on a study about retraction notices in journals of BioMed Central

    Thank you for your comments and feedback. Here we clarify the main scientific points raised.

    The retractions in this study span subject areas across the publisher’s portfolio of journals. Where multiple reasons for the retraction were given, the main over-arching reason why the retraction occurred was described. We clearly note in the paper that, in 13 cases of retraction there were two reasons given and in one case three reasons were given. The premise of the study was to look at reasons why published retractions occurred and if they adhered to COPE guidelines.
    The study period was from 2000-2015 and did not include an analysis of any retractions which took place in 2016. Our analysis includes full articles, not abstracts published as supplements in journals.

    BioMed Central’s Editorial Policy page (http://www.biomedcentral.com/getpublished/editorial-policies) contains details of our retraction policy and information on COPE membership.
    Thank you for flagging that some retractions have been displayed as errata. This was not the case when the retractions were published and has only come about recently due to system updates to our websites. This has now been resolved.
    BioMed Central as a Publisher is a member of COPE, as well as all individual BioMed Central journals.

    All BioMed Central’s research articles are available as we are an...

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  • Process Evaluation: Unlikely

    Dear Editors and Authors,

    I am astonished the article and the methodology are titled as a 'process evaluation'? None of what the article describe's in its methodology lends itself to a process evaluation framework. A proper evaluation process involves assessment of the program objectives and how the program activities are tracking towards the objectives. In addition, sophisticated versions of process evaluation assess the theory behind the implementation and if the participants are receiving the benefits stated in the objectives. From what I read in the article, there isn't any of this nor a program logic: textual or illustrated. It is a really poor form to have titled this article as a program evaluation, while it is nothing but a qualitative data collection.

    Sincerely yours,
    Dr Sandeep Reddy

  • A call for more adherence to guidelines for creatinine and potassium monitoring and discontinuation following renin–angiotensin system blockade.

    Schmidt et al examined the adherence to serum creatinine and potassium monitoring and discontinuation guidelines following initiation of treatment with ACE inhibitors (ACEI) or angiotensin receptor blockers (ARBs) in a general practice-based cohort study using electronic health records from the UK Clinical Practice Research Datalink and Hospital Episode Statistics.; and whether high-risk patients were monitored.1 223,814 new ACEI/ARB users were investigated.1 Only 10% of patients had neither baseline nor follow-up monitoring of creatinine within 12 months before and 2 months after initiation of an ACEI/ARB, 28% had monitoring only at baseline, 15% only at follow-up, and 47% both at baseline and follow-up.1 The median period between the most recent baseline monitoring and drug initiation was 40 days (IQR 12–125 days). 34% of patients had baseline creatinine monitoring within 1 month before initiating therapy, but <10% also had the guideline-recommended follow-up test recorded within 2 weeks. Among patients experiencing a creatinine increase ≥30% (n=567, 1.2%) or potassium level >6 mmol/L (n=191, 0.4%), 80% continued treatment.1 Although patients with prior myocardial infarction, hypertension or baseline potassium >5 mmol/L were at high risk of ≥30% increase in creatinine after ACEI/ARB initiation, there was no evidence that they were more frequently monitored.1

    In our opinion, it is indeed disheartening and most disappointing that healthcare providers contin...

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    Leprosy Post-Exposure Prophylaxis (LPEP) programmes is a good initiative for tropical stigmatized disease leprosy.
    A single dose of rifampicin given to contacts of new patients with leprosy was found to be 57% effective in preventing the development of clinical leprosy after two years.1 The findings of the study helps to use single dose rifampicin as a cheap and practical preventive intervention for contacts of patients with leprosy control programmes but implementing in the field is a promising act.
    The protocol of LPEP is designed nicely for evaluating the feasibility and its impact on case detection rates by contact tracing and administration of single dose rifampicin for consented contacts. There are few more points to be considered when it is implemented in the practical set up or in the field. A note or information regarding the adverse effects or flu like syndrome should be noted in the protocol. Even though the side effects/adverse events are rarely seen in a single dose it is mandate to note the possible adverse events/effects due to rifampicin.
    It was found that approximately 5063 were females in rifampicin received group in the study by Moet et al1. As the protocol clearly mentioned regarding the age restrictions in pediatrics and pregnancy status as an exclusion criteria, the reproductive age group especially women should be interviewed properly regarding her plan for pregnancy or plan for postponement of pregnancy by means of any drugs or bar...

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