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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...
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 future work to better understand how patient reported outcomes relate to ascertainable or medically defined outcomes isn’t needed, our reporting was accurate and achieved the primary objective of this study - which was to highlight PICC-associated patient concerns and opportunities for care improvement.
"What is needed now is an understanding of what is the threshold of professional nurse staff and complementary staff needed to achieve optimal outcomes, and how are these levels influenced by patient nursing acuity and the education, experience, organisation and work environment of the nurse workforce." --- I agree with you. Further, this study may be approached by Park's Optimized Nurse Staffing (Sweet Spot) Estimation Theory (Park, 2017): https://onlinelibrary.wiley.com/doi/full/10.1111/jan.13284. I am doing the research now.
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...
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 in the paragraph titled “Change in patient-reported complications over time”. The study limitations clearly note that the signs and symptoms reported could not be interpreted within the context of comorbidities, nor could the complications be confirmed without evidence in the medical record.
Study titles and terms will influence the readers – who in this case are clinicians and patients. It seems irresponsible to use the term “complication” without the qualifying word “possible” to accurately represent the findings and import of this study.
Krein et al have the best of intentions as they try to develop the body of knowledge around vascular access devices. However, an analysis of self-reported symptoms should not be represented as a complication rate.
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...
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 interventions chosen by O’Reilly-Shah et al. were based on, that changing ventilator defaults did not force anaesthetists to select a certain tidal volume, and audit-feedback dashboards might foster change through an increase in awareness of peer group behaviour.
Assessing preferences and costs may not be straightforward, as described in a critique of nudge theory by Berg & Davidson [3]. They argue that many choice decisions implicitly have a trade-off, and it is difficult to predict in advance which direction the balance tips. Furthermore, selecting a particular tidal volume (a continuous variable) for a particular patient during an operation might be a complex decision and not a binary option, which makes the cost or indeed the opportunity cost, of a particular choice difficult to ascertain, in economic parlance.
A study much vaunted by the New York Times Magazine demonstrating improvement in hand hygiene rates amongst clinicians after the introduction of screen savers depicting bacterial cultures from physicians’ hands, failed to be replicated in another study using a similar methodology, which suggests that audit-feedback dashboard techniques may not be robust [4, 5]. O’Reilly-Shah et al. state that most practitioners accepted the target ventilation strategy without debate but they also admit that there is equipoise in the anaesthetic literature regarding the benefit of a low-tidal volume strategy for elective surgical patients [1]. As such, the increased compliance rate might not have reflected the provider’s ‘better preference’ per se, but a trend towards the default lower tidal volume as it may not have been an important factor either way.
A better example using the authors’ approach might be the default setting of ‘pressure-controlled’ ventilation as opposed to ‘volume-controlled’ ventilation in paediatric patients undergoing general anaesthesia, to avoid the danger of delivering overtly dangerous large tidal volumes. This is sensible practice in paediatric, but in hospitals with mixed adult and paediatric populations, this may not always be appropriate. It would then represent a binary decision and the benefit would be more obvious.
References
1. O'Reilly-Shah VN, Easton GS, Jabaley CS, Lynde GC. Variable effectiveness of stepwise implementation of nudge-type interventions to improveprovider compliance with intraoperative low tidal volume ventilation. BMJ Qual Saf. 2018 May 18
2. Thaler RH, Sunstein CR. Nudge: Improving Decisions About Health, Wealth, And Happiness. New Haven : Yale University Press, 2008, p5-6.
3. Berg C, Davidson S. Nudging, calculation, and utopia, Journal of Behavioral Economics for Policy, Vol. 1, Special Issue, 49-52, 2017
4. Dubner SJ, Levitt SD. Selling soap. The New York Times Magazine, September 24, 2006.
5. Charters M, Cheng AL, Esaki RK, Kuo AS, Neal J, Thawani JP, Chenoweth C. The impact of a screensaver in promoting hand hygiene. Am J Infect Control. 2009 Dec;37(10):867-8
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...
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 be shown well using a generalised additive model (GAM). Its confidence limits can be useful as they delimit the range of the predicted mean supported by the GAM analysis. Trends and change-points may be identified. However, this fails to address potentially outlying individual observations such as large monthly counts and rates. It is suggested that the supported ranges identified by the confidence intervals about the individual monthly values can help identify outliers. Finally, a seasonal trend test can help identify the trends and change-points that frequently accompany determined efforts to improve or that complicate a deteriorating process. Admittedly, these observations apply chiefly to rate data such as bacteraemias and new isolates of antibiotic-resistant organisms. However, there are also binary data to which they apply.
Reference
1. Morton, A., Whitby, M., Tierney, N., Sibanda, N. and Mengersen, K. 2016. Statistical Methods for Hospital Monitoring. Wiley StatsRef: Statistics Reference Online. 1–8.
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...
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 burdens of staff workflow coordination. Moreover, a shorter period would threaten external validity, rendering evidence from the study potentially uninformative for policy decisions that could affect the lives of millions. Thus, a shorter study would be of little social benefit while imposing unjustifiable risks and burden. A planned interim analysis was independently reviewed by a Data Safety Monitoring Board out of consideration for patient safety, but termination was unwarranted.[3]
If the policy intervention is ethically unacceptable, the study should not be done under any time frame. Yet, the debate over U.S. resident duty hours is marked by equipoise: it is not at all clear that flexible duty hours pose greater risk than duty hour regulations that interrupt critical patient care (e.g., leaving during an operation) or lead to more patient care hand offs.[4] Considerable literature demonstrates adverse effects on patient outcomes of excessive care transitions [5,6] along with residents’ concerns that training may suffer with reductions in duty hours.[7-10]
Hemming et al. are well-intentioned in articulating ethical concerns arising from gratuitously large clusters. However, in trials designed to inform policy, the importance of external validity may justify ostensibly “large” cluster sizes.
Respectfully yours,
Karl Y. Bilimoria, M.D., M.S.
Jeanette W. Chung, Ph.D.
Larry V. Hedges, Ph.D.
[4] Philibert I, Nasca T, Brigham T, Shapiro J. Duty-hour limits and patient care and resident outcomes: can high-quality studies offer insight into complex relationships? Ann Rev Med. 2013;64:467-483
[5] Denson JL, Jensen A, Saag HS, et al. Association between end-of-rotation resident transition in care and mortality among hospitalized patients. JAMA. 2016;316(21):2204-2213
[6] Denson JL, McCarty M, Fang Y, et al. Increased mortality rates during resident handoff periods and the effect of ACGME duty hour regulations. Am J Med. 2015;128(9):994-1000
[7] Ahmed N, Devitt KS, Kshet I, et al. A systematic review of the effects of resident duty hour restrictions in surgery: impact on resident wellness, training, and patient outcomes. Ann Surg. 2014;259(6):1041-1053
[8] Drolet BC, Spalluto LB, Fischer SB. Residents’ perspectives on ACGME regulation of supervision and duty horus – a national survey. N Engl J Med. 2010;363:e34
[9] Drolet BC, Christopher DA, Fischer SA. Residents’ response to duty-hour regulations – a follow-up national survey. N Engl J Med. 2012;366:e35
[10] Fargen KM, Chakraborty A, Friedman WA. Results of a national neurosurgery resident survey on duty hour regulations. Neurosurgery. 2011;69(6):1162-1170
[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....
[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.S. and Canada. We are working to expand and improve services we provide to healthcare workers.
As noted, multiple studies confirm the PHP model’s remarkable remission rates from substance use disorders. The combination of sufficient initial treatment, often amongst a cohort of peers, with chronic disease management (comprised of frequent random substance screening, ongoing support group attendance and needed adjuvant pharmacotherapy, psychotherapy and psychiatric care) results in a five-year remission rate of approximately 80 percent. Remarkably this chronic disease management model shows exactly the same efficacy in opioid use disorders as other substance problems.4 This stands in sharp contrast to the suboptimal outcomes seen in the general population as we struggle to find solutions to the international problem of opioid use disorders. The outcomes achieved by PHPs have led to assertions this model of treatment should be considered for all addiction disorders, including opioid use disorders.5
Outcomes for other behavioral health conditions have been less clear, with few papers addressing outcomes in this area.6 We believe this is partly due to the lack of a uniform systematic disease management model for treating depressive illnesses, stress and burnout among physicians and other healthcare workers. The FSPHP is the North American forum of evolving concepts in in the management of chronic mental health conditions.
PHPs in the U.S. and Canada are less directly involved with medical skill dyscompetence per se, except in cases where the dyscompetence arises from, or is exacerbated by, interpersonal difficulties, behavioral or medical illness. In North America, such problems are more often addressed through credentialing bodies and medical boards (US) and colleges (Canada). A network of evaluators assess physician competency and assist PHPs, medical boards and medical colleges in determining individual needs and remediation strategies.
Maintaining a healthy and competent healthcare workforce requires a collaborative effort by organized medicine inclusive of the multiple stakeholders that oversee and/or represent health professionals. We see Weenink, et al.’s fine paper as a call to action to do more. The FSPHP is eager to answer this call by sharing our efforts collaboratively with our international partners to enhance, expand and explore current and future pathways to a safe healthcare workforce around the world. Surely, we owe all those we serve in the day to day practice of medicine the “globalization” of effective models of remediation and rehabilitation for healthcare professionals.
Paul H. Earley, M.D., DFASAM
Brad Hall, M.D., DABAM, DFASAM, MROCC, AAMRO
Chris Bundy, MD, MPH
References
1. J.-W. Weenink, R. B. Kool, R. H. Bartels, and G. P. Westert. "Getting Back on Track: A Systematic Review of the Outcomes of Remediation and Rehabilitation Programmes for Healthcare Professionals with Performance Concerns." British Medical Journal Quality & Safety 26, no. 12 (2017): 1004.
2. R. DuPont, A. McLellan, G. Carr, M. Gendel, and G. Skipper. "How Are Addicted Physicians Treated? A National Survey of Physician Health Programs." J Subst Abuse Treat 37, no. 1 (2009): 1-7.
3. AMA Council on Mental Health. "The Sick Physician: Impairment by Psychiatric Disorders, Including Alcoholism and Drug Dependence." JAMA 223, no. 6 (1973): 684-87.
4. K. Domino, T. F. Hornbein, N. L. Polissar, G. Renner, J. Johnson, S. Alberti, and L. Hankes. "Risk Factors for Relapse in Health Care Professionals with Substance Use Disorders." JAMA 293, no. 12 (2005): 1453-60.
5. R. L. DuPont, W. M. Compton, and A. T. McLellan. "Five-Year Recovery: A New Standard for Assessing Effectiveness of Substance Use Disorder Treatment." J Subst Abuse Treat 58 (2015): 1-5.
6. J. R. Knight, L. T. Sanchez, L. Sherritt, L. R. Bresnahan, and J. A. Fromson. "Outcomes of a Monitoring Program for Physicians with Mental and Behavioral Health Problems." J Psychiatr Pract 13, no. 1 (2007): 25-32.
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 “...
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 “rapid obsolescene of the products ... is hardly compatible with the delay necessary for clinical trials, particularly morbidity-mortality data.” and recommended “predictive equivalence, the check of the results of the specific test Bench”.(3)
The weak regulation of medical devices, for both efficacy and safety, is an exception in the healthcare system. Exceptions in health never benefit to patients.
1 Gagliardi AR, Ducey A, Lehoux P et al. Factors influencing the reporting of adverse medical device events: qualitative interviews with physicians about higher risk implantable devices. BMJ Qual Saf 2018;27:190-198.
2 Braillon A. Assessment of medical devices: the Emperor's new clothes. Br J Radiol 2018. Online April 24. doi: 10.1259/bjr.20180242
3 Braillon A. Medical devices and the approval processes: United States vs France. Arch Intern Med. 2010;170:2040-1.
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...
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 generated through the quality department from 2016. Patients were excluded if they were incarcerated, had other indications of antibiotics on admission, had a planned urological procedure within 48 hours, pregnant, or had charts containing incomplete data. The final convenience sample size of 432 included patients were analyzed.
In general, patients were more likely not to have classical urinary symptoms (symptomatic: n=65, 15%; asymptomatic: n=367, 85%). Urine cultures were ordered in 151 patients (symptomatic: n=33, 51%; asymptomatic: n=118, 32%; p=0.004); of which, 53 (35%) had a positive culture result. Most of these patients (n=38, 72%) were asymptomatic; yet, they received inappropriate antibiotics for treatment of ASB (n=25, 66%). Typically, patients received third-generation cephalosporins (n=16, 64%) or a fluoroquinolone (n=4, 16%) and were treated for an average of 3 days. This correlates with our previously published data showing a 62% inappropriate treatment rate of ASB at our institution five years prior to this cohort. Previously, we decreased this rate to 26% following an education period. [2]
Lab ordering algorithms, such as the one used by Stagg et al, would address the issues found in our institution. We educated prescribers on the overtreatment of ASB, but demonstrated that educational initiatives at academic hospitals lose effectiveness over time. Antimicrobial stewardship programs (ASPs) can leverage electronic medical record prescribing to educate clinicians on appropriate ordering of urine tests when patients lack classical and non-classical urinary symptoms. Two-step urine culture ordering, combined with additional rationale for urine culture processing (documentation of urinary symptoms in the processing order), would allow for additional stop measures to ensure appropriate urine culture ordering, provide documentation for clinicians to retrospectively audit the process, and promote lab stewardship on the front lines. Inappropriate management of patients with ASB has been a substantial challenge for ASPs over the past ten years that has brought unfortunate burdens on the healthcare system that we as clinicians have the power to stop.
REFERENCES:
1 Stagg A, Lutz H, Kirpalaney S, et al. Impact of two-step urine culture ordering in the emergency department: a time series analysis. BMJ Qual Saf. 2018;2:140-147.
2 Kelley D, Aaronson P, Poon E, et al. Evaluation of an antimicrobial stewardship approach to minimize overuse of antibiotics in patients with asymptomatic bacteriuria. Infect Control Hosp Epidemiol. 2014;2:193-5.
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...
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 is measured and reported in a manner that underpins improvement in healthcare is challenging for a number of reasons. Firstly, many of the measurement instruments have their limitations with regards to utility and ease of use (3). Many of the harms that are subject to measurement are believed to be preventable but it is often challenging to establish the extent to a specific harm can be prevented (3). Pressure injuries are the quintessence of how challenging it can be to ascertain the preventability of a specific harm as they can be arise through the complex interplay of different factors at any point in the patient’s care continuum. The measurement of harm in healthcare is a social practice that is undertaken in complex adaptive system in which a number of organisational contextual, organisational and human factors are at play. The impact of these factors is epitomised by the fact that a focus on measuring harm can have unintended consequences such as gaming and effort substitution (3, 4) which undermine improvement efforts. In addition, measurement systems are often calibrated to report past harms and so provide a limited but important insight into contemporary patient safety (3).
In light of the challenges of measurement, it is important to consider what other sources of routinely collected data can be used to underpin pressure injury related quality improvement efforts. For example, pressure injury related patient safety incident reports often contain ‘soft data’ which helps to identify the human, causative and contributory factors give result in adverse events (5). Therefore, patient safety incident reports provide valuable soft data into aspects of harm that can exist beyond of formal measurement systems and may constitute fugitive knowledge. The analysis of patient safety incident reports has been shown (5) to be an effective way of informing national and population level improvement efforts because patient safety incident reports provide unique insights into the factors that give rise to adverse event which are often overlooked at a local level. It may astute to combine the ‘soft data’ and soft intelligence that can be obtained from pressure injury related patient safety incident reports and other sources with the hard data obtained through formal measures of harm to inform quality improvement interventions.
References
1. Padula WV, Pronovost PJ. Addressing the multisectoral impact of pressure injuries in the USA, UK and abroad. BMJ Quality & Safety. 2018;27(3):171-3.
2. Squitieri L, Ganz DA, Mangione CM, Needleman J, Romano PS, Saliba D, et al. Consistency of pressure injury documentation across interfacility transfers. BMJ Qual Saf. 2018;27(3):182-9.
3. Dixon-Woods M. Measuring what matters: how can we know we are delivering prudent healthcare? Saving 1000 Lives Wales; Cardiff: Saving 1000 Lives Wales Available from: http://www.1000livesplus.wales.nhs.uk/sitesplus/documents/1011/marydixon... 2014.
4. Kelman S, Friedman JN. Performance Improvement and Performance Dysfunction: An Empirical Examination of Distortionary Impacts of the Emergency Room Wait-Time Target in the English National Health Service. Journal of Public Administration Research and Theory. 2009;19(4):917-46.
5. Samuriwo R, Williams H, Cooper J, Carson-Stevens A. Improving skin care through data: a pitch for patient safety incident reporting. Journal of Wound Care. 2016;25(12):691
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...
Show More"What is needed now is an understanding of what is the threshold of professional nurse staff and complementary staff needed to achieve optimal outcomes, and how are these levels influenced by patient nursing acuity and the education, experience, organisation and work environment of the nurse workforce." --- I agree with you. Further, this study may be approached by Park's Optimized Nurse Staffing (Sweet Spot) Estimation Theory (Park, 2017): https://onlinelibrary.wiley.com/doi/full/10.1111/jan.13284. I am doing the research now.
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...
Show MoreO’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.
Show MoreI 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...
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...
Show MoreHemming 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...
Show More[This is a revision of a submission from earlier today that contains references.]
To the editor:
Show MoreWe 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....
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 “...
Show MoreWe 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...
Show MorePressure 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.
Show MoreEstablishing systems in which patient harm i...
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