Article

Reply to the Letter titled “Platelet indices may not be associated with diagnosis and prognosis of gastrointestinal bleeding”

Correspondence / American Journal of Emergency Medicine 37 (2019) 762793 763

Table 2

Primary and secondary endpoints.

Lauren N. Hunt, PharmD, BCPS

ILUM Health Solutions, 2000 Galloping Hill Rd., Kenilworth, NJ 07033,

sepsis management bundle

Intervention

Comparator

p-Value

United States of America

Median [IQR] or n (%)

3-hour bundle completion

n = 22

20 (91)

n = 58

49 (85)

0.72

Jennifer Elfman, PharmD

Time to completion (minutes)

59 [34.5-64.3]

70.5 [49-121.5]

0.013

Department of Pharmacy, Osceola Regional Medical Center, 700 W Oak St,

Kissimmee, FL 34741, United States of America

6-hour bundle completion

n = 13

11 (84.6)

n = 37

29 (78.4)

1.0

Time to completion (minutes)

181 [91-208]

183 [126-211]

0.58

Time to completion of individual bundle components (minutes)

n = 22

n = 58

Fluids

13 [12-24.3]

35 [20.8-61.8]

0.002

Blood cultures

22 [12-29]

25.5 [17-53]

0.09

Antibiotics

46 [31-61.5]

68 [49-96]

0.009

Antibiotics within 60 min

16 (72.7)

19 (32.8)

0.002

15 May 2018

We found no difference between groups for the primary endpoint of 3-hour or 6-hour bundle compliance, but the time to completion of the 3-hour bundle and several individual components were significantly shorter when a pharmacist was present, which is consis- tent with a previous study [8]. Rapid antibiotic administration and completion of the 3-h bundle has been associated with lower risk-adjusted in-hospital mortality [9]. In 2018, the Surviving Sepsis Campaign published a special article advocating the combination of the 3- and 6-hour bundles into a single “hour-1 bundle.” This is intended to promote more rapid initiation of treatment and prevent the extension of resuscitation measures over a long period of time [10]. There are multiple limitations of this study. First, a single center study may have less external validity and generalizability to other institutions. There may have been missed opportunities as daily activities do not always allow for prompt pharmacist response to sepsis alerts. Finally, the definitions used for sepsis, severe sepsis, and septic shock are based on current CMS definitions and criteria that differ from those

used by guidelines updated after the initiation of this study [11].

Early identification and appropriate management of sepsis and sep- tic shock is critical for improving patient outcomes. The results of this study suggest that the incorporation of pharmacists as a standard part of the multidisciplinary sepsis response team may significantly decrease time to treatment in patients presenting to the ED with sepsis.

Conflicts of interest

None.

Acknowledgements

At the time of the study, the authors were employed by Florida Hospital Orlando, Orlando, FL.

Nicholas Yarbrough, PharmD Department of Pharmacy, Memorial Hermann The Woodlands Medical Center, The Woodlands, TX 77380, United States of America

Meghan Bloxam, PharmD

Pharmacy Department, Tampa General Hospital, 1 Tampa General Cir,

Tampa, FL 33606, United States of America

James Priano, PharmD, BCPS* Patricia Louzon Lynch, PharmD, BCPS, BCCCP Department of Pharmacy, Florida Hospital Orlando, 601 East Rollins Street,

Orlando, FL 32803, United States of America

*Corresponding author at: Department of Pharmacy, Florida Hospital Orlando, 601 East Rollins Street, Orlando, FL 32803,

United States of America.

E-mail address: [email protected].

https://doi.org/10.1016/j.ajem.2018.08.009

References

  1. Dellinger RP, Levy MM, Rhodes A, et al. Surviving sepsis campaign: international guidelines for management of severe sepsis and septic shock, 2012. Intensive Care Med 2013;39(2):165-228.
  2. Centers for Medicare & Medicaid Services. CMS specifications manual version 5.2b. https://www.qualitynet.org/dcs/ContentServer?c=Page&pagename=QnetPublic% 2FPage%2FQnetTier3&cid=1228775749207; 2018, Accessed date: 5 July 2018.
  3. Rivers E, Nguyen B, Havstad S, et al. Early goal-directed therapy in the treatment of severe sepsis and septic shock. NEJM 2001;345(19):1368-77.
  4. Levy MM, Rhodes A, Phillips GS, et al. Surviving sepsis campaign. Crit Care Med

    2015;43(1):3-12.

    Centers for Medicare & Medicaid Services. CMS Measure Inventory Tool. https:// cmit.cms.gov/CMIT_public/ListMeasures; 2018, Accessed date: 5 July 2018.

  5. Gaieski DF, Mikkelsen ME, Band RA, et al. Impact of time to antibiotics on survival in patients with severe sepsis or septic shock in whom early goal-directed therapy was initiated in the emergency department*. Crit Care Med 2010;38(4):1045-53.
  6. Kumar A, Roberts D, Wood KE, et al. Duration of hypotension before initiation of ef- fective antimicrobial therapy is the critical determinant of survival in human septic shock*. Crit Care Med 2006;34(6):1589-96.
  7. Moussavi K, Nikitenko V. Pharmacist impact on time to antibiotic administration in patients with sepsis in an ED. Am J Emerg Med 2016;34(11):2117-21.
  8. Seymour CW, Gesten F, Prescott HC, et al. Time to treatment and mortality during mandated emergency care for sepsis. N Engl J Med 2017;376(23):2235-44.
  9. Levy MM, Evans LE, Rhodes A. The surviving sepsis campaign bundle: 2018 update. Intensive Care Med 2018;44(6):925-8.
  10. Singer M, Deutschman CS, Seymour CW, et al. The Third International Consensus Definitions for Sepsis and Septic shock (Sepsis-3). JAMA 2016;315(8):801-10.

    Platelet indices may not be associated with diagnosis and prognosis of gastrointestinal bleeding

    Dear Editor,

    I read with a great interest the article of Senel et al. about the diag- nostic and prognostic value of platelet indices in the gastrointestinal system bleeding [1]. The authors reported that platelet indices might be used in diagnosis and prognosis of gastrointestinal bleeding. I would like to comment about this paper.

    Firstly, the data of this study were obtained retrospectively. Pre- analytical and analytic factors are important sources of variations or errors in clinical Laboratory measurements. Several factors like as partially clotting of specimen with activation and aggregation of platelets during venipuncture, ethylenediaminetetraAcetic acid (EDTA)-induced platelet aggregation, severe microcytosis, fragmentation of red cells or presence of cryoglobulinemia may affect the correct measurement platelet count and indices. If there is any suspicion about occurrence of the measure- ment error, the complete blood count should be repeated with a second sample. Reliability of tests cannot provide completely in retrospective

    Abbreviations: EDTA, ethylenediaminetetraacetic acid, MPV, mean platelet volume, PCT, plateletcrit.

    764 Correspondence / American Journal of Emergency Medicine 37 (2019) 762793

    studies due to pre-analytical and analytical factors. Harrison and Goodall emphasized categorically importance of that all blood samples should be collected, handled and processed in the same way so that the effect of pre- analytical variables in Mean platelet volume studies [2].

    Secondly, although the platelet indices include platelet count, plateletcrit , MPV, and platelet distribution width may be rou- tinely reported with complete blood count, their measurements have not standardized yet. Noris et al. reviewed the clinical importance of MPV measurement in recent years and they notified that because the wide variability of MPV as well as the very poor standardization of the methodologies used for MPV measurement, it has presently no role in making diagnosis and defining prognosis in any acquired illness in real life [3]. The MPV is dependent on time of analysis after sampling, method of analysis, anticoagulant used and specimen storage tempera- Declaration of interest statement”>ture [4]. The authors reported that blood platelets were measured usage with Sysmex XE 2100 hematology analyzer, but the measurement times after blood sampling were not standardized as specified in discussion. MPV increases progressively by exposure to EDTA. This increment in MPV occurs up to 30% within 5 min and then gains extra 10-15% over the subsequent 2 h [4]. The MPV measurements by the MPV measure- ment times varied up to 12.5% in a meta-analysis study and this differ- ence was notified as 2-50% by the review of Jackson and Carter [4,5]. Because the measurement times after blood sampling were not stan- dardized in this study, the accuracy of data was questionable.

    PCT is the volume occupied by platelets in the blood as a percentage and calculated according to the formula; PCT = platelet count x MPV / 10,000 [6]. Therefore, the standardization problems related with MPV values affect the calculated PCT values. Thus, the accuracy of PCT data was questionable, too.

    In conclusion, MPV and PCT values may not be associated with diagnosis and prognosis of gastrointestinal bleeding.

    Declaration of interest statement

    The author has nothing to disclose.

    Funding

    This research did not receive any specific grant from funding agen- cies in the public, commercial, or not-for-profit sectors.

    Cengiz Beyan

    Ufuk University Faculty of Medicine, Department of Hematology,

    Ankara, Turkey E-mail address: [email protected].

    10 July 2018

    https://doi.org/10.1016/j.ajem.2018.08.010

    References

    Senel T, Ates I, Demir BF, Arikan MF, Karaahmetoglu S, Altiparmak E, et al. The diagnostic value of platelet indices in the gastrointestinal system bleeding and its place in predicting prognosis. Am J Emerg Med 2019;37:657-63.

  11. Harrison P, Goodall AH. Studies on mean platelet volume -new editorial policy.

    Platelets 2016;27:605-6. https://doi.org/10.1080/09537104.2016.1225467.

    Noris P, Melazzini F, Balduini CL. New roles for mean platelet volume measurement in the clinical practice? Platelets 2016;27:607-12. https://doi.org/10.1080/09537104. 2016.1224828.

  12. Jackson SR, Carter JM. Platelet volume: laboratory measurement and clinical applica- tion. Blood Rev 1993;7:104-13.
  13. Beyan C, Beyan E. Were the measurements standardized sufficiently in published studies about mean platelet volume? Blood Coagul Fibrinolysis 2017;28:234-6. https://doi.org/10.1097/MBC.0000000000000586.
  14. Budak YU, Polat M, Huysal K. The use of platelet indices, plateletcrit, mean platelet volume and platelet distribution width in emergency non-traumatic abdominal sur- gery: a systematic review. Biochem Med (Zagreb) 2016;26:178-93. https://doi.org/ 10.11613/BM.2016.020.

    Assessing the methodological quality of retrospective research protocols

    Medical records are informal collections of impressions and observa- tions that contain both objective and subjective information attained during the patient care process. They are not designed or created for re- search but frequently are used for this secondary purpose. While chart review studies tend to be inexpensive, relatively easily performed, and do not generally require specialized equipment, there are limitations to this type of study [1]. Information in medical charts is usually at least two steps removed from the patient with clinicians recording pa- tient information, often with an intermediate transcription, followed by the chart abstractor recording data [2]. This can lead to recording er- rors, misinformation, and incomplete data. Understanding potential pit- falls in these studies allows the investigator to attempt to address them in the research design phase. Although there are no universally ac- cepted criteria for a “well-conducted” chart review, there are recom- mended strategies to enhance the validity, reproducibility, and overall quality of data collected from clinical records [3,4]. The aim of our study is to review research proposals submitted to the Institutional Re- view Board (IRB) at one academic medical center to 1) determine the proportion of research protocols that use data exclusively from chart re- views; and 2) assess and quantify the quality of these protocols using published methodologic criteria.

    We conducted a retrospective cross-sectional analysis using re-

    search proposals submitted to the IRB at one academic-affiliated medi- cal center during a one-year study period. Inclusion criteria included any original research proposals that relied solely on data from medical records to answer the questions posed by the study. Exclusion criteria included research proposals relying on death certificates, coroners’ re- ports, or other public records, and all studies based on animal or labora- tory investigations. Additional exclusion criteria included retrospective studies based on aggregate patient data and computerized databases, case reports and case series, systematic reviews, studies withdrawn by investigator, and those studies categorized as not human subjects re- search (NHSR).

    Experienced IRB analysts evaluated the quality of protocols using a checklist of methodological criteria adapted from the published lit- erature in collaboration from the Department of Epidemiology at Michigan State University [3-5]. For each criterion, a rating of “Yes” or “No” was assigned. Credit was given if the investigators men- tioned the methodologic standard, whether or not details were pro- vided. In order to ensure the accuracy of data abstraction, all of the investigators assessed several mock research proposals to evaluate the consistency of coding and to clarify the Coding system. One in- vestigator met frequently with abstractors to resolve questions and ensure consistency of abstraction and coding. Any proposals that were questionable were evaluated by all investigators and discussed to reach consensus and assign a code. A blinded critical review of a random sample of 10% of the charts was done to determine interrater reliability. The Interrater agreement for this sample of charts was de- termined using kappa statistics. Descriptive statistics (mean, SD) and frequency tables were used to describe the key quantitative and qualitative variables.

    During the study period, 265 studies were submitted to the IRB; 100 studies were excluded from analysis because they were categorized as NHSR (60%), exempt (19%), withdrawn by investigator (18%), or were evaluated primarily by another IRB (3%). A total of 165 protocols were included in our analysis. This represented 76% of all the eligible proto- cols submitted in 2015. These retrospective protocols represented 28 medical specialties, including orthopedics (15%), pediatrics (11%), sur- gery (10%), pharmacy (9%), cardiovascular (8%), and emergency medi- cine (6%). Faculty physicians were generally the principal investigators (PI) (72%), followed by residents (15%), pharmacy staff (8%), nursing staff (2%) and medical students (2%). There was wide variability (3.6%

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