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January 2016 Featured Articles, Volume 222
Get credit right away by taking all CME tests online http://jacscme.facs.org Article 1: Liver, Biliary, Pancreas
Fibrin sealant with polyglycolic acid felt vs fibrinogen-based collagen fleece at the liver cut surface for prevention of postoperative bile leakage and hemorrhage: a prospective, randomized, controlled study. Kobayashi S, Takeda Y, Nakahira S, et al. J Am Coll Surg 2016;222:59e64 Article 2: Endocrinology, Thyroid, Parathyroid
Prospective intervention of a novel levothyroxine dosing protocol based on body mass index after thyroidectomy. Elfenbein DM, Schaefer S, Shumway C, et al. J Am Coll Surg 2016;222:83e88 Article 3: Burn, Trauma, Critical Care
Surveillance and early management of deep vein thrombosis decreases rate of pulmonary embolism in high-risk trauma patients. Allen CJ, Murray CR, Meizoso JP, et al. J Am Coll Surg 2016;222:65e72 Article 4: Burn, Trauma, Critical Care
Validation of the Denver Emergency Department Trauma Organ Failure Score to predict post-injury multiple organ failure. Vogel JA, Newgard CD, Holmes JF, et al. J Am Coll Surg 2016;222:73e82
Objectives: After reading the featured articles published in this issue of the Journal of the American College of Surgeons (JACS) participants in this journal-based CME activity should be able to demonstrate increased understanding of the material specific to the article featured and be able to apply relevant information to clinical practice. A score of 75% is required to receive CME and Self-Assessment credit. The JACS Editor-in-Chief does not assign a manuscript for review to any person who discloses a conflict of interest with the content of the manuscript. Two articles are available each month in the print version, and up to 4 are available online for each monthly issue, going back 24 months.
ARTICLE 1 (Please consider how the content of this article may be applied to your practice.)
Fibrin sealant with polyglycolic acid felt vs fibrinogen-based collagen fleece at the liver cut surface for prevention of postoperative bile leakage and hemorrhage: a prospective, randomized, controlled study Kobayashi S, Takeda Y, Nakahira S, et al J Am Coll Surg 2016;222:59e64 Learning Objectives: After study of this article, surgeons should be able to explain the incidence of major morbidities after liver surgery, to compare the effectiveness of sealant at the liver cut surface, and to advise patients accordingly.
Accreditation: The American College of Surgeons is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.
Question 1 The incidence of biliary leakages reported by the International Study Group of Liver Surgery (ISGLS) after a liver operation was:
Designation: The American College of Surgeons designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 Credit. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
a) b) c) d) e)
<1% 1% to 2% 4% to 6% 9% to 12% 15% to 20%
Critique: Before definition of biliary leakage by ISGLS in 2011, the definition in each study was varied ª 2016 Published by Elsevier Inc. on behalf of the American College of Surgeons.
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and the incidence differed with diagnostic definitions, in a range of 4% to 16%. This multicenter, randomized, controlled study to explore the efficacy of fibrin sealant with polyglycolic acid felt (PGA-FS) and fibrinogen-based collagen fleece (CF) for prevention of postoperative biliary leakage started in 2009 and the authors used the original definition. According to the ISGLS definition, the rate of biliary leakage was 9.0% in PGA-FS and 11.9% in CF. This difference likely related to differences in definitions. Question 2 Regarding fibrin sealant with an artificial absorbable material, polyglycolic acid felt (PGA-FS) vs fibrinogen-based collagen fleece (CF): a) PGA-FS could withstand pressures >100 cmH2O in an experimental animal study. b) PGA-FS was used for preventing air leakage in thoracic surgery and cerebrospinal fluid leakage in neurosurgery. c) CF has been generally used at liver cut surface for preventing biliary leakage. d) PGA-FS could reduce biliary leakage in liver surgery compared with CF. e) PGA-FS and CF could not be used in laparoscopic liver resection. Critique: To prevent postoperative biliary leakage and hemorrhage, several devices and biochemical compounds have been explored. Recently, for hemostasis of the liver cut surface, CF has been generally used and appears to reduce the incidence of postoperative hemorrhage, but another approach would be necessary for prevention of biliary leakage. The effect of the combination of fibrin sealant (FS) and collagen for prevention of biliary leakage might be limited. The authors used an artificial absorbable material, PGA felt as a supportive material with FS, as a means of preventing air leakage in thoracic surgery and cerebrospinal fluid leakage in neurosurgery. The PGA-FS withstood pressures >40 cmH2O in an experimental animal study. According to the previous retrospective study, the authors decided to conduct a multicenter, prospective, randomized controlled study to explore the efficacy of PGA-FS, and the type of surgical procedure was not restricted. Question 3 Comparing fibrin sealant with polyglycolic acid felt (PGA-FS) to fibrinogen-based collagen fleece (CF) in liver surgery, PGA-FS was more effective in reducing:
a) b) c) d) e)
Postoperative hemorrhage Biliary leakage Organ / space surgical site infection around the liver Superficial surgical site infection Ascites
Critique: The results of the multicenter, randomized, controlled study, regarding a difference between PGA-FS and CF at the liver cut surface, showed no difference in the prevention effect on biliary leakage and hemorrhage. As secondary outcomes, the rate of morbidity was 21.6% in the full analysis set of our study group; 18.7% in PGA-FS and 24.6% in CF (p ¼ 0.0450). For components of morbidity, superficial and deep SSI and organ/ space SSI did not differ between groups; however, infection around the liver (abscess) showed a trend toward occurring more often in CF (6.6%) than in PGA-FS (3.6%) (p ¼ 0.0555), and the rate of abdominal paracentesis was higher in CF (5.1%) than in PGA-FS (2.3%) (p ¼ 0.0400), but ascites was not statistically different. Jaundice rates showed a trend to being higher in CF (1.5%) than in PGAFS (0.3%) (p ¼ 0.0595). Other morbidities did not differ between groups. Question 4 Regarding treatment for morbidities after liver resection using fibrin sealant with polyglycolic acid felt (PGA-FS) or fibrinogen-based collagen fleece (CF): a) In 2% of the patients using PGA-FS, paracentesis was necessary. b) In 2% of the patients using CF, paracentesis was necessary. c) In 5% of the patients using PGA-FS, relaparotomy was necessary. d) In 5% of the patients using CF, relaparotomy was necessary. e) Relaparotomy for postoperative hemorrhage was more likely in the CF group. Critique: The incidence of morbidities after liver surgery was lower in PGA-FS than that in CF. Regarding treatment for morbidities; laparotomy was performed less often than abdominal paracentesis. The rate of abdominal paracentesis was higher in CF (5.1%) than in PGA-FS (2.3%). The major reason for relaparotomy was different between PGA-FS and CF, but the overall rate of laparotomy was the same (1% to 2%). The rate of relaparotomy for hemorrhage was 0.8% for both groups.
Vol. 222, No. 1, January 2016
ARTICLE 2 (Please consider how the content of this article may be applied to your practice.)
Prospective intervention of a novel levothyroxine dosing protocol based on body mass index after thyroidectomy Elfenbein DM, Schaefer S, Shumway C, et al J Am Coll Surg 2016;222:83e88 Learning Objectives: After study of this article, surgeons should be able to implement into their practice a protocol for levothyroxine dosing after thyroidectomy. Surgeons should be able to critically evaluate various published protocols, understanding that study design and number of subjects may limit generalizability. Question 1 All of the following have been suggested as factors that influence levothyroxine dosing after thyroidectomy EXCEPT: a) b) c) d) e)
sex age pituitary gland function ideal body weight body mass index
Critique: When a patient undergoes total thyroidectomy, the entire body’s thyroid hormone requirements must be supplied by exogenous levothyroxine taken orally. This medication is absorbed from the gastrointestinal system and finds its way to the bloodstream, where it then acts on almost every body system. The pituitary gland secretes thyroid stimulating hormone (TSH) in response to low levels of levothyroxine in the bloodstream in a negative feedback loop, and TSH is a reliable measure of euthyroidism for most people. In patients with abnormal pituitary gland function, TSH is not a dependable measure of overall body thyroid hormone status because the normal feedback loops are not normal, but abnormal pituitary function does not influence the amount of levothyroxine a patient requires, only the manner in which one can measure it. Sex, age, and lean muscle mass (ideal body weight and BMI measure some component of this) alter a body’s volume of distribution as well as change the ratio of cells that require more or less levothyroxine to function optimally, so each probably plays some role in optimal dosing. Absorption of the drug also plays an important role, so patients are instructed on various medications or foods that can alter absorption of the drug.
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Question 2 Implementation of a BMI-based levothyroxine dosing protocol resulted in which of the following statistically significant improvements at the first TSH measurement when compared with weight-based dosing? a) Less underdosing for patients with BMI 27 to 32 kg/m2 b) More euthryoid levels for patients with BMI 16 to 26 kg/m2 c) Less overdosing for patients with BMI 27 to 32 kg/m2 d) Less underdosing for patients with BMI > 33 kg/m2 e) More euthyroid levels for patients with BMI > 33 kg/m2 Critique: For patients with mid-range BMI (27 to 32 kg/m2), the multiplier for the BMI-based protocol was 1.6 body weight in kilograms, which essentially is the same as straight weight-based dosing. Not surprisingly, there was very little change in the number of euthyroid patients in this subset. For the heaviest patients, there was a slight improvement in the number of patients who were overdosed, which resulted in more patients achieving euthyroidism on their initial dose, but these numbers were not statistically significant. For patients with BMI of 16 to 26 kg/m2, there were fewer patients who were both overdosed and underdosed, resulting in a statistically significant improvement in the number of euthyroid patients at the first TSH check. Question 3 One strength of this study is its prospective design, following patients in real time. What is one distinct advantage of a prospective study over a retrospective design? a) b) c) d) e)
Prospective Prospective Prospective Prospective Prospective outcome.
studies take less time to complete. studies allow one to study rare diseases. studies are less expensive. studies are prone to recall bias. studies yield true rates of the desired
Critique: Although retrospective studies are relatively fast and inexpensive and allow researchers to study rare diseases, they are subject to biases that prospective studies can minimize, such as recall bias. For this particular study, the retrospective cohort on which the BMI-based protocol was created looked at patients in a post-hoc manner, giving only a best fit estimate of any individual patient’s levothyroxine needs. However, applying that protocol in real-time allowed the authors
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to measure the exact rate of the desired outcome, in this case, euthyroidism. Question 4 Issues in operationalizing protocols such as the one proposed in this article can decrease the performance and lessen the effect on patient outcomes. Which of the following will likely lead to the greatest improvement in compliance with a protocol in a hospital where the system for ordering medications is electronic? a) Give every resident a laminated pocket card with the protocol printed on it. b) Integrate the protocol into the electronic order entry system so that the dose is auto-calculated for each patient according to the protocol. c) Hold a single training session on the first day of each month for all team members.
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d) Design an online module about the protocol for team members to complete. e) Create patient education materials so that patients can check their own dose to make sure it fits the protocol. Critique: Patient compliance and team member training are important, but human error can occur, even among the smartest, best-trained people, as a result of fatigue, multi-tasking, or a host of other common issues. Protocols are designed to improve quality of care by using the best evidence for a clinical situation. When building a protocol into an automated system, it is important to build in safeguards and ways to safely deviate from auto-calculated doses when the situation calls for it. If these safeguards are assured, then putting patient care protocols into the electronic medical record will probably lead to the greatest improvement in compliance.
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January 2016 Featured Articles, Volume 222 Fibrin sealant with polyglycolic acid felt vs fibrinogen-based collagen fleece at the liver cut surface for prevention of postoperative bile leakage and hemorrhage: a prospective, randomized, controlled study Kobayashi S, Takeda Y, Nakahira S, et al. J Am Coll Surg 2016;222:59e64 Prospective intervention of a novel levothyroxine dosing protocol based on body mass index after thyroidectomy Elfenbein DM, Schaefer S, Shumway C, et al. J Am Coll Surg 2016;222:83e88