679 e-Letters

  • Reply to the comment "A sandwich won’t sway a doctor"

    We acknowledge of course that the pharmaceutical industry produces many medicines that are an important part of healthcare. However, inappropriate use and overuse of medicines is detrimental to health, and use of an unnecessarily expensive medicine that is no better than a cheaper alternative represents wasteful health care spending.

    Although Mr. Catelin states “It’s ludicrous to suggest that a sandwich and a soda water would sway the opinions of medical practitioners”, the evidence shows otherwise. Among the studies that have examined the relationship between exposure to pharmaceutical industry information or payments and the quality, quantity and cost of prescribing, there is an overwhelming finding of no benefit. (1-4) Pharmaceutical industry payments, even small payments such as a meal, are associated with increased prescriptions of the promoted drug. One US study found a “dose-response effect” on prescribing of cholesterol-lowering drugs, blood pressure drugs and antidepressants, starting with even a single meal costing less than US $20: the more free meals a doctor ate, the more likely they were to prescribe the promoted drug. (2) Another study found that the more payments a doctor received from the industry, the more likely they were to prescribe expensive brand-name drugs rather than less expensive generic equivalents. (4)

    The aim of our study was neither to undermine patients’ confidence nor to call health professionals into disrepute. The aim was...

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  • Epistemonikos: A database not to be missed while searching systematic reviews

    We have read the article, “Systematic review of systematic reviews of non-pharmacological interventions to treat behavioral disturbances in older patients with dementia. The SENATOR-OnTop series” by Abraha et al. published in BMJ Open in March 2017 with a lot of interest. This systematic review study presents very important findings on the use of non-pharmacological interventions to treat behavioral disturbances in elderly dementia population.

    However, we have a specific concern about the database searched and relevant articles included in this systematic review of systematic reviews study. An important omission we found in this study was the systematic review by Kong et al.1 published in Aging & Mental Health Journal in July 2009. This systematic review and meta-analysis assessed the effectiveness of the nonpharmacological interventions for agitation in the older adults with dementia. It qualifies all the criteria for inclusion in the present study since it is published within the range of search duration (2009-2015 March) used in the present study. Furthermore, the present study has included the systematic reviews by Yu et al.2 published in March 2009 along with other systematic reviews such as Kverno et al.3 and Lai et al.4 published in the same year.

    Also, the systematic review by Kong et al.1 assessed the effect on agitation (a type of behavioral disturbance) not assessed by many of the other systematic reviews included in the present study hence m...

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  • Authors response to comments by Tom Boyles

    Dear Tom,

    Thank you for your comments.

    Your first point addresses the poor negative predictive value of a TB symptom screening test. We agree that the symptom screen that is currently called for in South Africa’s national guidelines, as well as WHO’s guidelines, is inadequate in terms of both negative and positive predictive value. We do not have, and you do not propose, however, an easily-available alternative. We consulted a number of TB experts in designing the algorithm and concluded that at the time of study initiation, there was no readily available clinical prediction rule or point-of-care instrument that we could expect to be adopted at a national scale if the trial’s results are compelling. We also designed the study to adhere as closely as possible to existing national guidelines, with the main difference being the timing of the initiation process rather than its content. Our goal is an algorithm that can be incorporated into routine practice as simply as possible, in the hope of benefiting patients at a large scale.

    We also observe that initiating ART in the presence of undiagnosed TB poses the risk of delayed TB treatment (which would have been delayed anyhow, due to the patient not having symptoms) or IRIS (which, while clinically occasionally challenging, is rarely fatal, especially in this group of ambulatory and largely healthy patients). We hypothesize that the well-characterized loss to follow-up and subsequent morbidity and mortal...

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  • A sandwich won’t sway a doctor

    A sandwich won’t sway a doctor.
    Milton Catelin
    Chief Executive, Medicines Australia

    Pharmaceutical companies and medical professionals collaborate on clinical research, share knowledge and support education to ensure that medicines are constantly improving and are used safely and appropriately by health care professionals and their patients.

    Our members are proud of the work that we do to ensure that the public can continue to have confidence in our local medicines industry. We consider transparency to be a key component of the bond of trust with the Australian public.

    Engagement with pharmaceutical companies is an important and legitimate part of a medical practitioner’s ongoing education; foremost, because patients want to be sure that their doctors know how to use the medicines they’re being prescribed.

    The developers of these medicines are the highest authority on how a medicine works, its interactions with other compounds, its efficacy and other information. It stands to reason that a medical practitioner would consider information from the maker of the medicine when making an informed decision about prescribing a medicine. It’s not however, the only source. Medical practitioners do their own research, network with their peers, consult with other clinical experts, read independent medical journals and receive information from independent bodies such as NPS MedicineWise.

    It’s ludicrous to suggest that a sandwich and a so...

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  • Response to comment by Prof. Hughes

    Dr Hughes raises an important point that we also address in discussing limitations of the study. We did not take meta-analyses into consideration that had combined studies with inactive treatments and treatment as usual (TAU) as control interventions. We based this decision primarily on methodological reasons. TAU varies widely across patients and settings and can include antidepressant or behavioral treatments. Therefore, equating TAU with placebo treatment or waiting list seemed problematic for us.

    Nevertheless, Dr. Hughes’ point is well taken. TAU is an important reference standard, particularly in pragmatic studies because it reflects real-world conditions. In a meta-analysis, however, TAU is difficult to handle especially when the components of TAU across individual trials are not well documented. Using TAU in a meta-analysis often comes down to combining apples and oranges without being able to tell which treatments are the apples and which are the oranges.

    Dr. Hughes also argues that patients on waiting lists cannot be prevented from getting some form of treatment. We agree but view this as a general issue of contamination that is almost impossible to control, particularly in pragmatic studies. The fact that, in our study, patients on active treatments had substantially larger treatment effects than those on waiting lists makes us think that contamination issues probably did not have much impact.

  • Response to Dr Conviser's comments

    Dear Dr Conviser,

    Thank you for your comments. Please find our responses to those comments below, itemised 1 to 6:

    1. Your protocol calls for 8 months of exposure to the bio Density system. Manufacturers recommendations supported by peer reviewed studies have shown that BMD changes require a minimum of 9 months and many individuals begin to show changes with DEXA at the 11 and 12 month period.

    Could you please clarify to which specific manufacturer recommendations and peer-reviewed studies you refer?
    We note that BMD changes have indeed been observed within 6 months when an intervention has been sufficiently intense [1]. A single BMU will complete a full remodelling cycle in roughly 4 months, but we certainly agree the mineralisation lag limits sensitivity of ionising radiation devices to detect change before 6 months [2]. We therefore balanced an imperative to apply our intervention for longer than 6 months to increase our opportunity to detect a BMD treatment effect, with the requirement to complete the trial within the time period that we have access to the bioDensity device. Our confidence that 8 months will provide a sufficient intervention duration is derived from the BMD response observed in the LIFTMOR trial for women where we applied the identical training duration (see early findings publication [3] - final outcomes are under revision.) In light of your concerns, we are interested in the rationale behind your ch...

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  • Note on grey literature search strategy

    Since publication of the article, we have been made aware that although we had identified and included a number of grey literature reports using the Sheffield Alcohol Policy Model, some reports by the Sheffield team had not been identified by our search strategy. As with many systematic reviews, our efforts searching for studies mainly focused on published peer-reviewed literature. Given the nature of and interest in alcohol minimum unit pricing by a number of think tanks, had we also included the websites of leading think tanks in our search.

    Some of the unidentified reports overlap to varying degrees with peer-reviewed studies by the same team which had been included in our review, such as Purshouse 2010, Holmes 2014 and Meier 2016. However had we identified others (listed below), these would have been included in the article. Whilst they use the same model and are conducted by the same team, they would nevertheless have lent further support for the consistency, specificity, dose-response, plausibility and coherence criteria.

    The conclusions of our article are unaffected, with the evidence suggesting strongly that MUP will reduce alcohol consumption and harm

    Angus, C., Meng, Y., Ally, A., Holmes, J. and Brennan, A. (2014) 'Model-based appraisal of minimum unit pricing for alcohol in Northern Ireland: An adaptation of the Sheffield Alcohol Policy Model version 3', Sheffield: ScHARR, University of Sheffield.
    Angus C, Holmes J,...

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  • Revised standardised mortality ratios for underlying and mentioned cause Parkinson’s Disease

    Since the publication of our mortality study of a workforce manufacturing paraquat [1], the cohort which had been flagged by the Medical Research Information Service of the National Health Service (now NHS Digital) has had to be pseudonymised. This provided an opportunity to check the records held by NHS Digital against our own. We were also able to flag some individuals who it had not been possible to trace when originally sent to be flagged thirty years previously, including one worker known to have died but with unknown cause of death. As a consequence, three new deaths were identified which had occurred before the end of follow up (30 June 2009). Two deaths occurred in workers that we had previously thought were alive at the end of follow up, and one in a worker who could not previously be traced and who had been treated as lost to follow up.

    Most of the reported standardised mortality ratios (SMR) were little changed. However, one of the newly identified deaths was due to Parkinson’s Disease (PD), the primary endpoint, and has increased the number of observed deaths due to PD from one to two versus 1.8 expected (SMR=110; 95% CI 13 to 400). Similarly the number of death certificates mentioning PD has increased from one to two versus 3.3 expected (SMR=61; 95% CI 7 to 222). Nevertheless, the extra death due to PD doesn’t change the conclusion of the paper that there was no evidence of increased mortality (underlying and mentioned cause) from PD. Furthermore none...

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  • Clinical algorithm and sample size

    Dear Sydney-
    I have a number of concerns regarding the design of the SLATE trial that I would like to share. There are two important questions regarding ART initiation in ambulatory patients that you are addressing. The first is how to appropriately screen patients for conditions that preclude immediate initiation of ART and the second is the best time to initiate ART in ambulatory patients.
    The SLATE protocol begins with addressing the first question with a step-wise algorithm to identify patients who require further investigation for a variety of clinical conditions but most notably tuberculosis and cryptococcal disease. The first stage is a standardised WHO TB symptom screen which has been shown to be have an inadequate negative predictive value in high burden settings, particularly in patients who are not on ART. Rangaka et al (Clinical Infectious Diseases 2012;55(12):1698–706) showed in a South African cohort that 8.9% of patients with a negative symptoms screen who were not on ART had culture confirmed TB. More recently Hanifa et al (CROI 2015 abstract number: 823) showed that around 5.6% of patients who were recently diagnosed with HIV had a negative symptom screen but culture confirmed TB. The SLATE algorithm provides for further assessment for TB in patients without symptoms but this relies on a symptom-guided physical exam, this is poorly defined and it is unclear how this will pick-up TB in asymptomatic patients. It is therefore likely that between 5...

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  • A high workload is a heavy workload

    Letter to the Editor

    Topic: A high workload is a heavy workload

    I was quite interested to read that Rippstein-Leuenbergeret al., (2017), made reference to ‘high workload’ as an area that is very stressful for nurses. High workload may be regarded as ‘the ratio of nurses to the number of patients’ (Carayon & Gurses, 2008), and ‘the number of nursing interventions related to direct patient care’ (Lee et al., 2017).
    As a registered nurse with over 20 years of experience working in Emergency rooms in hospitals both in England and the United States, and teaching, I am able to relate to the highly stressful work areas experienced by nurses working not only in Intensive Care Units but also in other areas as well . In my experiences, nurses typically made references to ‘heavy workload’ to also describe high nurse to patient ratios, compared to ‘high workload’ as used by the above authors.
    According to Carlesi et al.,(2017), and Lee et al., (2017), ‘high workload’ and ‘heavy workload’ (Kendall-Raynor, 2011; Hakonsen et al., 2010) are used in studies to refer to the same thing. In fact, Carayon and Gurses (2008) used both terms in their study.
    It is my humble suggestion, therefore, that as both ‘high workload’ and ‘heavy workload’ are terms that can, and have been, used interchangeably to mean the same thing, this letter should be amended to the above study to allay any misconception that may arise from future readership.

    “A qualita...

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