41 e-Letters

published between 2016 and 2019

  • Authors response to comment by Maureen E. Burger

    We appreciate the concerns raised and agree that accurately presenting the findings of our study regarding patient-reported possible PICC-related complications is important. We took several steps to ensure transparency in how we presented our data. First, we were vigilant about consistently defining our outcomes as “possible complications” in all key areas of the paper including the main outcomes and conclusions section of the abstract, study measures section in the methods, main findings in the results section and in the discussion. The fact that the term “possible” or “potential” was not always used or some terms appeared to be used interchangeably was to improve readability of the article. In general, however, we were conscientious about clearly noting that we asked patients about signs or symptoms of a potential complication or adverse effect. Second, we purposefully chose to not present the data as complication rates (implying that these were actual events), but as the percentage of patients reporting a given event – thus we faithfully represented what we were told by patients during follow-up assessments. Third, we took these approaches because our primary objective was to accurately present the data collected from our patients; if something mattered enough to a patient to tell us about it, then it should matter to us as healthcare professionals regardless of internal standards that we may use to define serious medical complications. While that’s not to say that f...

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  • Patient-reported complications related to peripherally inserted central catheters: a multicentre prospective cohort study

    Krein, et al (Patient-Reported Complications Related to Peripherally Inserted Central Catheters: A Multicenter Prospective Cohort Study; Feb 2019) should be commended for sharing the results of this very interesting study. After reading it a few times, I am compelled to share the following concerns with you and the research team. The knowledge regarding PICC-related complications is indeed incomplete, but I am not sure if the main outcome(s) of your study are clearly represented to the reader.

    The word “possible” is critical to correctly interpreting the results of this study. The term “complication” implies a medical diagnosis or medical confirmation – which your study attempted to do by conducting the chart reviews to confirm the presence or absence of a PICC complication, with limited success. Terms such as signs, symptoms, issues, adverse effects, and complications are used interchangeably throughout the paper to describe the patients’ self-reported experience, but without the benefit of operational definitions. These are not synonyms. Definitions help us to have a common understanding of a word or topic; they help us get on the same page when reading about an issue.

    The word “possible” seems appropriate in the main outcome(s) statement, but is curiously missing from the report title. The phrase “medical complications” is used in the title of Table 2 – which clearly reports predominantly patient self-reported symptoms. The same bias is exhibited...

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  • Beware the pitfalls of nudge theory

    O’Reilly-Shah et al. present a novel approach to quality improvement in anaesthesia by attempting to elicit change in practice using ‘nudge theory’ derived from the field of behavioural economics [1]. Translating new research evidence into common clinical practice is an important quality issue and cheap and effective strategies to achieve this are of interest. O’Reilly-Shah et al. hypothesised that using ‘nudge-type’ interventions, an audit-feedback dashboard as well as changes to mechanical ventilator default settings, might improve anaesthesia provider compliance with this ‘lung protective’ ventilation strategy in the general operating theatre environment.
    I disagree with the conclusion that the authors have drawn, that these interventions might improve clinical and financial outcomes. My disagreement stems from the clinical rationale of the intervention, which overlaps onto the assumptions built into the ‘nudge theory’ of behavioural economics itself.
    Sunstein & Thaler, who have influenced large scale policy making in several countries, describe nudge theory as a form of choice architecture that “alters people’s behaviour in a predictable way without forbidding any options or significantly changing their economic incentives” [2, 3]. Their philosophy is described as “libertarian paternalism”, as it influences choices that make people better off as judged by themselves, while preserving their freedom to choose otherwise. This is presumably what the interve...

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  • SPC and Complexity

    Conventional statistical process control (SPC) has limitations when used with hospital averse event (AE) data. Much data, especially hospital infections like bacteraemias, arise in complex systems.1 These differ from the simple or complicated industrial systems that produce data that are analysed with such success with conventional SPC. AE data arising in complex systems are often nonlinear. Expected values are often unknown. There is often delay in obtaining the AE data e.g. with bacteraemia data – the patient has symptoms, a blood sample is obtained, it is sent to pathology for culture, analysis and reporting and is finally placed in a suitable database then analysed (one of the benefits of conventional SPC is in providing rapid feedback so an industrial process that is going out of control is promptly identified). Most hospital AEs are relatively uncommon and alert staff such as those in Infection Management will frequently detect a change well before a statistical analysis. However, analysis using a time-series chart is still desirable. It can add confirmation to the observations of Infection Management and Quality Improvement staff. A hospital department can summarise its performance with a chart. Management and the public can be informed. A problem is devising control limits about an often non-existent expected value using a linear mean value that may be atypical of much of the data.

    How may this dilemma be overcome? The often changing predicted mean value can...

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  • External Validity Is Also an Ethical Consideration in Cluster-Randomized Trials of Policy Changes

    Hemming et al. (“Ethical Implications of Excessive Cluster Sizes in Cluster Randomized Trials,” 20 February 2018) cite the FIRST Trial as an example of a “higher risk” cluster-randomized trial in which large cluster sizes pose unjustifiable excess risk. The authors state, “[t]he obvious way to reduce the cluster size in this study is to reduce the duration of the trial…”

    We believe this to be an inappropriate recommendation stemming from an inaccurate appraisal of the FIRST Trial.

    The FIRST Trial was designed to inform a potential policy change in U.S. resident duty hours. In the Statistical Analysis Plan, which was made available at www.nejm.org, we clearly and prospectively stated that “[t]his study is a trial-based evaluation of potential policy effects on patient safety and resident wellbeing... this study is intended to inform real-world policy decision-making with respect to resident duty hours regulation.”[1] The SAP and Supplemental Appendix (www.nejm.org) also provides all assumptions for our power calculations and cluster sizes, which were not large in the case of resident outcomes.[2]

    As such, it was important that the trial closely resemble real-world conditions in which residency training occurs and duty hour policies are implemented. A shorter study would pose risks owing to non-standard, multiple policy shifts and would increase administrative/organizational bu...

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  • Physician Health in North America

    [This is a revision of a submission from earlier today that contains references.]

    To the editor:
    We read Weenink, et al.’s review of remediation and rehabilitation programs for healthcare professionals with interest.1 It is among the most systematic and certainly the most internationally focused reviews to date. The article noted, “the aim of these programs is two-fold: to help professionals with problems and to protect patients from professionals who are unable to perform adequately.” This important point is in direct alignment with the Federation of State Physician Health Program’s (FSPHP) philosophy of supporting our member programs in their mission of early detection of potentially impairing illness. As members of the leadership of the Federation of State Physician Health Programs (FSPHP), we laud this review and believe additional commentary is worthwhile.
    In the U.S. and Canada, each Physician Health Program (PHP) is unique in its scope of services, funding and the types of healthcare professionals served.2 In the U.S., we trace our roots back to a seminal paper that appeared in the Journal of the American Medical Association (AMA) in 1973.3 As Weenink, et al. noted, all programs provide services for professionals with substance use disorders and other mental health conditions. PHPs do not provide treatment, rather, we provide care coordination and monitoring for health professionals with impairing illness. The FSPHP brings together PHPs in the U....

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  • Reporting of adverse medical device events: From both sides of the Atlantic.

    Gagliardi and her Canadian colleagues must be commended for calling a spade a spade: “there may be little point in solely educating or incentivising individual physicians to report adverse medical device events unless environmental conditions are conducive to doing so”.(1) “Environmental conditions” being “healthcare system capacity and industry responsiveness”.(1) The French state of affairs illustrates the latter is not about unresponsiveness but deliberate obstructions.

    First, in March 2017, after serial warning letters, the French regulatory agency required withdrawal of YSY Medical’s medical devices within a 6 months delay as devices have been marketed without CE marking (Conformité Européenne _European Conformity, in 1985 France was a leader in the Union_ which is about basic safety standards (eg. no explosion, no electrocution …). YSY Medical challenged the decision before a regional administrative court which: a) considered the topic was in its jurisdiction; b) issued an emergency ruling to suspend the Agency’s decision. The Conseil d’Etat, France’s highest court, confirmed the ruling in 2018.(2)

    Second, after a suit by the Snitem (National Union of Medical Technologies Industries) and Medtech (an association of 40 companies), the Conseil d’Etat just cancelled a decree (#1716. 13 Dec 2016) requiring a summary of product characteristics for class III and implantable devices.

    However, France is improving. In 2009, the Agency’s director wrote “...

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  • Inappropriate antibiotic prescription for asymptomatic bacteriuria

    We read with great interest the original research done by Stagg et al where rates of unnecessary antibiotic use for asymptomatic bacteriuria (ASB) were decreased by implementing a two-step urine culture algorithm in the emergency department (ED). [1] We want to congratulate the authors for their successful research, and hope that algorithms such as the two-step ordering process will be implemented as widespread protocol to help decrease the overutilization of antibiotics for ASB.

    We have presented the findings of our own retrospective observational IRB-approved study performed at a 695-bed academic medical center to discern the downstream impact of routine urinalysis and urine cultures ordered from the ED on antibiotic prescribing. We hope these results will add to the growing body of evidence for stricter protocol regarding urine testing and subsequent treatment. The primary objective of our study was to evaluate the incidence of antibiotic treatment based on urinalysis and urine culture results with or without associated urinary symptoms. Secondary objectives included: incidence of symptoms documented in the medical record for patients who were ordered a urinalysis with or without urine culture, incidence of antibiotic treatment of ASB, and quantification of mean antibiotic dose given to patients with clinically defined ASB.

    Adult patients who had urinalysis with or without a urine culture performed in the ED were identified and randomized by reports genera...

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  • Pressure injury documentation: the case for using incident reports to inform quality improvement

    Pressure injuries are a largely avoidable adverse patient safety event, which are the focus of considerable global quality improvement efforts. Recent papers by Padula and Pronovost (1) and Squitieri et al. (2) highlight some of the challenges that exist with regards to efforts prevent and reduce the extent of patient harm arising from pressure injuries. These challenges include inconsistent reporting of the extent of pressure injury related harm as evinced by differences in the pressure injury related documentation from different care settings (1, 2) which are thought to be due to financial penalties for nosocomial pressure injuries (1). Padula and Pronovost (1) highlight the fact that the majority of the measurement and reporting of pressure injuries as well as the financial penalties for pressure injuries focus on hospital settings when pressure injury can arise at any point during a patient’s care trajectory. A number of possible solutions are put forward by Padula and Pronovost (1) to avoid underreporting the true extent of pressure injuries and to generate more accurate data that can be used to prevent and reduce the number of patients with pressure injuries in hospitals and other care settings. However, it is worth reflecting on the challenges of measurement and reporting for quality improvement and to considering what other routinely collected pressure injury related data can be used to inform improvement efforts.
    Establishing systems in which patient harm i...

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  • Pause before you nudge: ethical implications of behavioral economics and choice architecture in the health care setting

    The authors should be commended for highlighting some of the groundbreaking work on behavioral economics and touching on the potential for nudging in the clinical setting.1 Recently, others have advocated for the broad incorporation or nudge units within health systems.2 While the authors focus on physician-oriented nudges, for patient-directed nudges in particular, reflecting on the ethical implications of the nudge, and deciding to what degree patient autonomy is compromised, may be particularly important for physicians embarking on incorporating choice architecture into practice.

    There is an important distinction between engaging in what the original proponents of nudging termed “libertarian paternalism” (e.g., encouraging smoking cessation),3 and self-serving nudging (e.g., encouraging patients to choose a particular procedure or treatment, which may also benefit the physician or health care system).4 Indeed, concerns abound regarding the ethics of nudging the informed consent process, and pharmaceutical companies’ reliance on similar heuristics to improve sales is well established.5,6

    It is also worth highlighting that nudges are often experimental; as such, it is not always clear that they will have the desired effect, further stressing the need for an ethical pause. While these concerns are implicitly acknowledged by the authors, given the potential impact of nudges, and the lack of patient-facing transparency in developing choice architecture—a defini...

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