736 e-Letters

  • A valuable addition to the literature

    This paper is a very valuable addition to the literature on clinical trial transparency. It illustrates once again that self-regulation by the medical research sector does not work.

    One limitation is the data provided in the supplementary appendix. The authors could have listed the full information gathered on each trial, including trial number (where available), name of PI, and sponsor name. As the recent STAT investigation into unreported trials (https://www.statnews.com/2018/01/09/clinical-trials-reporting-nih/) has shown, making performance transparent in and of itself can drive the subsequent adoption of best practices, which is in the interests of patients and the research community alike.

    Even if confidentiality agreements precluded the identification of trials, it may have been possible to include more granular data without enabling the re-identification of specific trials. For example, many countries and funders have laws, policies and regulations that make prospective trial registration compulsory (https://docs.wixstatic.com/ugd/01f35d_def0082121a648529220e1d56df4b50a.pdf).

    Knowing in which countries (rather than aggregated global regions) the unregistered and retrospectively registered trials were conducted, which funders (rather than aggregated funder types) funded them,...

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  • Guidelines alone don't change practice, software might help.

    ​A fascinating review showing both over and under use of tests. One might conclude that we're not very good at following guidelines. Another view would be that guideline developers have failed to develop implementation plans and then track whether the guidance is being followed. As a General Practitioner I wonder how I'd perform if tested on the detail of the guidelines that were relevant to my practice. One factor that will be driving under / over testing will simply be ignorance. Only this morning I had to remind a colleague that the local antibiotic of choice for community pneumonia was amoxicillin not doxycyline. We need to recognise that some aspects of medicine are now too complex to rely on the practitioner's memory and consider developing minimally intrusive software which makes it easier to do the right thing.

  • Underestimation of chronic kidney diseasein persons with diabetes: ACE inhibitors and albuminuria

    Dear authors,

    We read the article titled "Screening for chronic kidney disease in a community-based diabetes cohort in rural Guatemala: a cross-sectional study" published in BMJ Open. The article summoned our interest as your research work is very much relevant to the operational research in the field of diabetes. The studies in the past have consistently reported, early screening for diabetes complications, risk stratification and adhering to management guidelines are the mainstay to reduce premature mortality. As estimates show almost 20% of all ESRD cases may be attributed to diabetes alone, the targeted screening for CKD among diabetes patients becomes imperative.1

    Though renal complications of diabetes are known to be common among persons with diabetes, there are no global estimates of burden and yield of targeted screening. Most of the data regarding the burden of CKD among diabetics is from isolated studies mostly from high-income countries.2 These studies have shown varied estimates based on the criteria’s, standards and techniques used to determine CKD in each of these studies. Also, a majority of the studies were based in tertiary care facilities and might have failed to report the real burden of the disease of interest in the risk group. In its latest guidelines, American Diabetes Association (ADA) recommended screening for Diabetes Kidney Disease through assessment of albuminuria and estimated glomerular filtration rate in all patients...

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  • The increases in population mortality observed in the past few years are more than just the result of an ageing population

    Ramsay points out that the UK’s ageing population was predicted to lead to an increase or slower rate of decline in mortality rates. However, our findings suggest that the changes in mortality rate are robust to an ageing population. In Supplementary Table S4, we show that most of the age groups above 60+ have significantly higher-than-expected mortality rates in 2012, 2013, and 2014. In particular, the mortality rates for the 85+ age group is consistently higher than expected for all years. If population mortality rates were expected to spike mostly as the result of an increasing proportion of very old people, we would not see such big spikes within these older age groups.

  • The conclusion that changes in spending are significantly associated with mortality is robust to the source of standardisation for calculating mortality rates

    As noted by Black, our use of the 1976 European standard population (ESP) reference instead of the 2013 ESP for age-standardising death rates (ASDR) is the source of the discrepancy between our ASDR and more recently published ONS ASDR.

    We calculated ASDr de novo using raw mortality counts and population data since ASDR broken down by sex and specific to England (not England and Wales) were unavailable at the time of data collection and initial data processing (mid-2014). To do this, we used the 1976 ESP data since to our knowledge, the 2013 ESP data were not available at that time.

    To demonstrate that the source of standardisation did not affect our conclusion, we re-processed the data using 2013 ESP data and re-ran the time-trend analyses. Despite this difference, we again found that the spending constraints of 2010/11 were linked with a significant increase in ASDR. Comparing the actual and predicted ASDR revealed 12,111 higher than expected number of deaths in 2012 (95% CI 4,912 to 19,309), 23,311 (95% CI 15,994 to 30,628) in 2013, and 20,351 (95% CI 12,865 to 27,838) in 2014 (see Figure 1: http://blogs.bmj.com/bmjopen/files/2018/01/BMJ-Open-Response-Figure-1.jpg). These numbers are all within the corresponding confidence intervals of the results using the 1976 ESP-standardised data.

    Furthermore, it is worth noting that our findings that life expectancy was si...

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  • Types of fractures and a bone strength

    The type of vertebral fractures object of the study of Smits et al. is defined as A2-C by AO [1]. The classification of AO of a thoracolumbar fracture includes three types of fractures: type A, type B and type C. Accordingly, type A has five subtypes:
    А0 – minor, nonstructural fractures;
    А1 – wedge-compression;
    А2 – split;
    А3 – incomplete burst;
    А4 – complete burst .
    Thoracolumbar fractures of type A2-C are not present in the AO classification [2].
    The article states that forty-six patients enrolled in the study were between 18 to 65 years of age but did not refer to the distribution of patients by age and gender. The bone quality will be different in one 18-year-old patient and a 65-year-old patient respectively [3]. Bone quality is important for the attachment of pedicular screw synthesis and it can be compromised in osteoporotic patients [4,5]. The use of three-point hyperextension brace in these patients postoperatively would be advisable [6].

    Abbreviation: AO – Müller AO Classification of fractures.


    1. Smits AJ, Deunk J, Stadhouder A, Altena MC, Kempen DHR, Bloemers FW. Is postoperative bracing after pedicle screw fixation of spine fractures necessary? Study protocol of the ORNOT study: a randomised controlled. http://bmjopen.bmj.com/content/8/1/e019596
    2. Spinal Fractures Classification System - AO: Tools....

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  • Authors' reply to Kumar: Limitation of Results

    Kumar raises concerns about the interpretation of our study examining the cost savings of different repeat prescription durations, and argues monthly dispensing should be maintained. We thank Mr Kumar for his comments and interest in our article and respond below.

    In response to Kumar's first point, our study suggests that with shorter prescription lengths, the cost savings due to reductions in waste are more than offset by the additional dispensing fees; these fees can therefore not be considered "nominal". White1 further highlights the non-nominal impact of additional dispensing fees due to short prescriptions lengths, estimating an additional cost of £700 million if all prescription items issued by the NHS in England were issued as 28-day repeat-dispensing items.

    We are also not aware of any evidence that increased frequency of contact with the community pharmacist (or indeed “indirect contact" with the GP authorising a prescription) due to shorter prescription lengths impacts in a valuable way in terms of patient outcomes as implied, either from a clinical or cost effectiveness perspective. Work by Elliott et al.2 has shown the pharmacy-based New Medicines Service to be cost-effective at improving adherence. However, un-targeted clinical pharmacy services, more generally, lack conclusive evidence of their effect on medication adherence and prescription appropriateness.3 Indeed, in many cases, the contact between patient and pharmacist...

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  • Thank you for your suggestion

    Thank you for your suggestion. We agree with you that parental autistic disorders might increase the risk of ASD in children. In our study, we set all parental psychiatric disorders (ICD-10 codes F00-F99) including autism disorders (ICD-10 codes F84.0 F84.1, F84.5, F84.8 and F84.9) as potential confounding factors, and we adjusted for mother psychiatric disorders (including ASD) in model 1, and father psychiatric disorders (including ASD) in model 2. Besides, we also conducted sibling-matched analyses to control for shared family-related confounding factors like genetic liability for neuropsychiatric conditions.

  • Lack of reliable data confuses discussion on safety of midwife-led and obstetrician-led care

    With interest we read the article of Wiegerinck et al. on intrapartum and neonatal mortality among low-risk women in midwife-led versus obstetrician-led care based on case notes and data from the Dutch national perinatal database (PRN, nowadays called ‘Perined’). In a recent commentary we addressed some important pitfalls associated with the use of register-based data.1 Although the authors acknowledge the methodological challenges of their study, and the limitations of the Perined database, it is important to specify these issues in more detail. Secondly, we want to challenge the interpretation of the findings.
    In this study clinical information regarding the women and babies in the numerators and denominators for intrapartum and neonatal mortality rates were derived from different sources. For the numerators information on women and their babies who died was taken from case notes. For the denominators information was taken from the Perined database, in which information on risk factors is often missing. The authors show in their supplementary file that in a sample of 100 women who started labour in obstetrician-led care no information was recorded for 13% of women on one or more of the eight risk factors which were defined as exclusion criteria in this study. Most women with risk factors will have been removed from the numerator, because information was available in their case notes. On the other hand, an unknown number of women with risk factors were not removed f...

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  • Limitation of Results

    The research result has emphasized that increase medicines waste with longer intervals. Also, increase Prescribing cost for shorterter intervals. These findings should lead to The authors of this article suggesting:
    - Shorter intervals save significant medicines waste in comparison to nominal dispensing fee and offers Very valuable patient contact with a healthcare professional.
    - Authors has totally ignored the e-Repeats and eRDS (EPS most important automation already in place in almost all GP surgeries & Pagrmacies) to save Significant Prescribing cost. That was the main one of the main purpose of EPS; authorities should look into using the existing Tools to savings on both Prescribing cost and reducing costly mesicine waste by keeping Monthly dispensing intervals.

    I hope, authorities use the existing wheels; rather than trying to reinvent / disbalance the existing wheels.