Multimodal Pain Protocol After Head and Neck Surgery in the Context of the Current Opioid Crisis

Background: The United States is in the midst of a public health crisis of prescription opioid addiction, abuse and overdose. Use of narcotic medication in the post-surgical setting may contribute to the problem. Multimodal analgesic plans have the potential to decrease narcotic requirements in patients after surgery; however, there is little prospective data to show efficacy in Head and Neck (H&N) surgery patients. Methods: An IRB approved, quality improvement initiative was undertaken to implement a multimodal analgesic protocol for all H&N surgery patients at a tertiary referral center. The protocol was implemented November 2017 and post-protocol data from January 2018 to May 2018 were compared to pre-protocol data from May 2017 to October 2017. Data were abstracted from the electronic health records as well as through pre-operative and post-operative surveys. Average pain scores and opioid use in Morphine Milligram Equivalents (MME) before and after protocol implementation were compared. Results: One-hundred-and-five post-protocol patients were compared to 167 pre-protocol patients. The adjusted median MME in the first 24 hours after surgery decreased significantly from 93.7mg to 58.6mg (p=0.026) with protocol implementation. When averaged over the length of stay (MME/HD), there was no significant change between the pre and post protocol cohort (57.9mg vs 46.8mg, p=0.211) The average pain score immediately after surgery was 3.6 and on the day of discharge was 2.7; neither measure changed with protocol implementation. Conclusion: Our multimodal analgesia plan reduced narcotic use immediately after surgery but not over the course of hospitalization. There was no difference in average reported pain scores. This study shows that implementation of a multimodal narcotic-sparing analgesia plan after H&N surgery is feasible. Future studies will need to further refine the optimal analgesia plan, optimize pain regimens for various patient characteristics and assess the long-term efficacy, safety and cost of such regimens.Master of Public Healt

Multimodal Pain Protocol After Head and Neck Surgery in the Context of the Current Opioid Crisis

Background: The United States is in the midst of a public health crisis of prescription opioid addiction, abuse and overdose. Use of narcotic medication in the post-surgical setting may contribute to the problem. Multimodal analgesic plans have the potential to decrease narcotic requirements in patients after surgery; however, there is little prospective data to show efficacy in Head and Neck (H&N) surgery patients. Methods: An IRB approved, quality improvement initiative was undertaken to implement a multimodal analgesic protocol for all H&N surgery patients at a tertiary referral center. The protocol was implemented November 2017 and post-protocol data from January 2018 to May 2018 were compared to pre-protocol data from May 2017 to October 2017. Data were abstracted from the electronic health records as well as through pre-operative and post-operative surveys. Average pain scores and opioid use in Morphine Milligram Equivalents (MME) before and after protocol implementation were compared. Results: One-hundred-and-five post-protocol patients were compared to 167 pre-protocol patients. The adjusted median MME in the first 24 hours after surgery decreased significantly from 93.7mg to 58.6mg (p=0.026) with protocol implementation. When averaged over the length of stay (MME/HD), there was no significant change between the pre and post protocol cohort (57.9mg vs 46.8mg, p=0.211) The average pain score immediately after surgery was 3.6 and on the day of discharge was 2.7; neither measure changed with protocol implementation. Conclusion: Our multimodal analgesia plan reduced narcotic use immediately after surgery but not over the course of hospitalization. There was no difference in average reported pain scores. This study shows that implementation of a multimodal narcotic-sparing analgesia plan after H&N surgery is feasible. Future studies will need to further refine the optimal analgesia plan, optimize pain regimens for various patient characteristics and assess the long-term efficacy, safety and cost of such regimens.Master of Public Healt

Inter-Observer Variation in the Pathologic Identification of Minimal Extrathyroidal Extension in Papillary Thyroid Carcinoma

Background: Extrathyroidal extension (ETE) is a significant prognostic factor in papillary thyroid carcinoma (PTC). Minimal extrathyroidal extension (mETE) is characterized by involvement of the sternothyroid muscle or perithyroid soft tissue, and is generally identified by light microscope examination. Patients with mETE, identified pathologically, are automatically upstaged to pT3. However, the prognostic implications of mETE have been a source of controversy in the literature. Moreover, there is also controversy surrounding the identification of mETE on pathological specimens. The objective of this study was to determine the level of agreement among expert pathologists in the identification of mETE in PTC cases. Methods: Eleven expert pathologists from the United States, Italy, and Canada were asked to perform a review of 69 scanned slides of representative permanent sections of PTC specimens. Each slide was evaluated for the presence of mETE. The pathologists were also asked to list the criteria they use to identify mETE. Results: The overall strength of agreement for identifying mETE was slight (??=?0.14). Inter-pathologist agreement was best for perithyroidal skeletal muscle involvement (??=?0.46, moderate agreement) and worst for invasion around thick-walled vascular structures (??=?0.02, slight agreement). In addition, there was disagreement over the constellation of histologic features that are diagnostic for mETE, which affected overall agreement for diagnosing mETE. Conclusions: Overall agreement for the identification of mETE is poor. Disagreement is a result of both variation in individual pathologists' interpretations of specimens and disagreement on the histologic criteria for mETE. Thus, the utility of mETE in staging and treatment of PTC is brought into question. The lack of concordance may explain the apparent lack of agreement regarding the prognostic significance of this pathologic feature.Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/140271/1/thy.2015.0508.pd

Inter-Observer Variation in the Pathologic Identification of Extranodal Extension in Nodal Metastasis from Papillary Thyroid Carcinoma

Background: Extranodal extension (ENE) in lymph node metastases has been shown to worsen the prognosis of papillary thyroid cancer (PTC). Despite the clinical significance of ENE, there are no stringent criteria for its microscopic diagnosis, and its identification is subject to inter-observer variability. The objective of this study was to determine the level of agreement among expert pathologists in the identification of ENE in PTC cases. Methods: Eleven expert pathologists from the United States, Italy, and Canada were asked to review 61 scanned slides of representative permanent sections of PTC specimens from Mount Sinai Beth Israel Medical Center in New York. Each slide was evaluated for the presence of ENE. The pathologists were also asked to report the criteria they use to identify ENE. Results: The overall strength of agreement in identifying ENE was only fair (??=?0.35), and the proportion of observed agreement was 0.68. The proportions of observed agreement for the identification of perinodal structures (fat, nerve, skeletal, and thick-walled vessel involvement) ranged from 0.61 to 0.997. Conclusions: Overall agreement for the identification of ENE is poor. The lack of agreement results from both variation in pathologists' identification of features and disagreement on the histologic criteria for ENE. This lack of concordance may help explain some of the discordant information regarding prognosis in clinical studies when this feature is identified.Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/140272/1/thy.2015.0551.pd

Comparing two service delivery models for the prevention of mother-to-child transmission (PMTCT) of HIV during transition from single-dose nevirapine to multi-drug antiretroviral regimens

<p>Abstract</p> <p>Background</p> <p>Mother-to-child transmission (MTCT) of HIV has been eliminated from the developed world with the introduction of multi-drug antiretroviral (md-ARV) regimens for the prevention of MTCT (PMTCT); but remains the major cause of HIV infection among sub-Saharan African children. This study compares two service delivery models of PMTCT interventions and documents the lessons learned and the challenges encountered during the transition from single-dose nevirapine (sd-nvp) to md-ARV regimens in a resource-limited setting.</p> <p>Methods</p> <p>Program data collected from 32 clinical sites was used to describe trends and compare the performance (uptake of HIV testing, CD4 screening and ARV regimens initiated during pregnancy) of sites providing PMTCT as a stand-alone service (<it>stand-alone site</it>) versus sites providing PMTCT as well as antiretroviral therapy (ART) (<it>full package site</it>). CD4 cell count screening, enrolment into ART services and the initiation of md-ARV regimens during pregnancy, including dual (zidovudine [AZT] +sd-nvp) prophylaxis and highly active antiretroviral therapy (HAART) were analysed.</p> <p>Results</p> <p>From July 2006 to December 2008, 1,622 pregnant women tested HIV positive (HIV+) during antenatal care (ANC). CD4 cell count screening during pregnancy increased from 60% to 70%, and the initiation of md-ARV regimens increased from 35.5% to 97% during this period. In 2008, women attending ANC at <it>full package </it>sites were 30% more likely to undergo CD4 cell count assessment during pregnancy than women attending <it>stand-alone </it>sites (relative risk (RR) = 1.3; 95% confidence interval (CI): 1.1-1.4). Enrolment of HIV+ pregnant women in ART services was almost twice as likely at <it>full package </it>sites than at <it>stand-alone </it>sites (RR = 1.9; 95% CI: 1.5-2.3). However, no significant differences were detected between the two models of care in providing md-ARV (RR = 0.9; 95% CI: 0.9-1.0).</p> <p>Conclusions</p> <p>All sites successfully transitioned from sd-nvp to md-ARV regimens for PMTCT. <it>Full package </it>sites offer the most efficient model for providing immunological assessment and enrolment into care and treatment of HIV+ pregnant women. Strengthening the capacity of <it>stand-alone </it>PMTCT sites to achieve the same objectives is paramount.</p

Effects of antibiotic resistance, drug target attainment, bacterial pathogenicity and virulence, and antibiotic access and affordability on outcomes in neonatal sepsis: an international microbiology and drug evaluation prospective substudy (BARNARDS)

Background Sepsis is a major contributor to neonatal mortality, particularly in low-income and middle-income countries (LMICs). WHO advocates ampicillin–gentamicin as first-line therapy for the management of neonatal sepsis. In the BARNARDS observational cohort study of neonatal sepsis and antimicrobial resistance in LMICs, common sepsis pathogens were characterised via whole genome sequencing (WGS) and antimicrobial resistance profiles. In this substudy of BARNARDS, we aimed to assess the use and efficacy of empirical antibiotic therapies commonly used in LMICs for neonatal sepsis. Methods In BARNARDS, consenting mother–neonates aged 0–60 days dyads were enrolled on delivery or neonatal presentation with suspected sepsis at 12 BARNARDS clinical sites in Bangladesh, Ethiopia, India, Pakistan, Nigeria, Rwanda, and South Africa. Stillborn babies were excluded from the study. Blood samples were collected from neonates presenting with clinical signs of sepsis, and WGS and minimum inhibitory concentrations for antibiotic treatment were determined for bacterial isolates from culture-confirmed sepsis. Neonatal outcome data were collected following enrolment until 60 days of life. Antibiotic usage and neonatal outcome data were assessed. Survival analyses were adjusted to take into account potential clinical confounding variables related to the birth and pathogen. Additionally, resistance profiles, pharmacokinetic–pharmacodynamic probability of target attainment, and frequency of resistance (ie, resistance defined by in-vitro growth of isolates when challenged by antibiotics) were assessed. Questionnaires on health structures and antibiotic costs evaluated accessibility and affordability. Findings Between Nov 12, 2015, and Feb 1, 2018, 36 285 neonates were enrolled into the main BARNARDS study, of whom 9874 had clinically diagnosed sepsis and 5749 had available antibiotic data. The four most commonly prescribed antibiotic combinations given to 4451 neonates (77·42%) of 5749 were ampicillin–gentamicin, ceftazidime–amikacin, piperacillin–tazobactam–amikacin, and amoxicillin clavulanate–amikacin. This dataset assessed 476 prescriptions for 442 neonates treated with one of these antibiotic combinations with WGS data (all BARNARDS countries were represented in this subset except India). Multiple pathogens were isolated, totalling 457 isolates. Reported mortality was lower for neonates treated with ceftazidime–amikacin than for neonates treated with ampicillin–gentamicin (hazard ratio [adjusted for clinical variables considered potential confounders to outcomes] 0·32, 95% CI 0·14–0·72; p=0·0060). Of 390 Gram-negative isolates, 379 (97·2%) were resistant to ampicillin and 274 (70·3%) were resistant to gentamicin. Susceptibility of Gram-negative isolates to at least one antibiotic in a treatment combination was noted in 111 (28·5%) to ampicillin–gentamicin; 286 (73·3%) to amoxicillin clavulanate–amikacin; 301 (77·2%) to ceftazidime–amikacin; and 312 (80·0%) to piperacillin–tazobactam–amikacin. A probability of target attainment of 80% or more was noted in 26 neonates (33·7% [SD 0·59]) of 78 with ampicillin–gentamicin; 15 (68·0% [3·84]) of 27 with amoxicillin clavulanate–amikacin; 93 (92·7% [0·24]) of 109 with ceftazidime–amikacin; and 70 (85·3% [0·47]) of 76 with piperacillin–tazobactam–amikacin. However, antibiotic and country effects could not be distinguished. Frequency of resistance was recorded most frequently with fosfomycin (in 78 isolates [68·4%] of 114), followed by colistin (55 isolates [57·3%] of 96), and gentamicin (62 isolates [53·0%] of 117). Sites in six of the seven countries (excluding South Africa) stated that the cost of antibiotics would influence treatment of neonatal sepsis

Multimodal Pain Protocol After Head and Neck Surgery in the Context of the Current Opioid Crisis

Background: The United States is in the midst of a public health crisis of prescription opioid addiction, abuse and overdose. Use of narcotic medication in the post-surgical setting may contribute to the problem. Multimodal analgesic plans have the potential to decrease narcotic requirements in patients after surgery; however, there is little prospective data to show efficacy in Head and Neck (H&N) surgery patients. Methods: An IRB approved, quality improvement initiative was undertaken to implement a multimodal analgesic protocol for all H&N surgery patients at a tertiary referral center. The protocol was implemented November 2017 and post-protocol data from January 2018 to May 2018 were compared to pre-protocol data from May 2017 to October 2017. Data were abstracted from the electronic health records as well as through pre-operative and post-operative surveys. Average pain scores and opioid use in Morphine Milligram Equivalents (MME) before and after protocol implementation were compared. Results: One-hundred-and-five post-protocol patients were compared to 167 pre-protocol patients. The adjusted median MME in the first 24 hours after surgery decreased significantly from 93.7mg to 58.6mg (p=0.026) with protocol implementation. When averaged over the length of stay (MME/HD), there was no significant change between the pre and post protocol cohort (57.9mg vs 46.8mg, p=0.211) The average pain score immediately after surgery was 3.6 and on the day of discharge was 2.7; neither measure changed with protocol implementation. Conclusion: Our multimodal analgesia plan reduced narcotic use immediately after surgery but not over the course of hospitalization. There was no difference in average reported pain scores. This study shows that implementation of a multimodal narcotic-sparing analgesia plan after H&N surgery is feasible. Future studies will need to further refine the optimal analgesia plan, optimize pain regimens for various patient characteristics and assess the long-term efficacy, safety and cost of such regimens.Master of Public Healt

Multimodal Pain Protocol After Head and Neck Surgery in the Context of the Current Opioid Crisis

Background: The United States is in the midst of a public health crisis of prescription opioid addiction, abuse and overdose. Use of narcotic medication in the post-surgical setting may contribute to the problem. Multimodal analgesic plans have the potential to decrease narcotic requirements in patients after surgery; however, there is little prospective data to show efficacy in Head and Neck (H&N) surgery patients. Methods: An IRB approved, quality improvement initiative was undertaken to implement a multimodal analgesic protocol for all H&N surgery patients at a tertiary referral center. The protocol was implemented November 2017 and post-protocol data from January 2018 to May 2018 were compared to pre-protocol data from May 2017 to October 2017. Data were abstracted from the electronic health records as well as through pre-operative and post-operative surveys. Average pain scores and opioid use in Morphine Milligram Equivalents (MME) before and after protocol implementation were compared. Results: One-hundred-and-five post-protocol patients were compared to 167 pre-protocol patients. The adjusted median MME in the first 24 hours after surgery decreased significantly from 93.7mg to 58.6mg (p=0.026) with protocol implementation. When averaged over the length of stay (MME/HD), there was no significant change between the pre and post protocol cohort (57.9mg vs 46.8mg, p=0.211) The average pain score immediately after surgery was 3.6 and on the day of discharge was 2.7; neither measure changed with protocol implementation. Conclusion: Our multimodal analgesia plan reduced narcotic use immediately after surgery but not over the course of hospitalization. There was no difference in average reported pain scores. This study shows that implementation of a multimodal narcotic-sparing analgesia plan after H&N surgery is feasible. Future studies will need to further refine the optimal analgesia plan, optimize pain regimens for various patient characteristics and assess the long-term efficacy, safety and cost of such regimens.Master of Public Healt