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• Authors response to comment by Maureen E. Burger
  Sarah L Krein, Vineet Chopra
  Published on: 24 June 2019
• Patient-reported complications related to peripherally inserted central catheters: a multicentre prospective cohort study
  Maureen E. Burger
  Published on: 19 June 2019

• Published on: 24 June 2019

  Authors response to comment by Maureen E. Burger

  • Sarah L Krein, Research Scientist and Research Professor of Internal Medicine VA Ann Arbor Healthcare System and University of Michigan
  • Other Contributors:
    • Vineet Chopra, Associate Professor of Medicine and Chief, Division of Hospital Medicine

  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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  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.

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  Conflict of Interest:
  None declared.

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• Published on: 19 June 2019

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

  • Maureen E. Burger, Chief Nursing Officer Visante, Inc.

  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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  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.

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  Conflict of Interest:
  None declared.

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