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Item A Retrospective Cohort Study Examining the Utility of Perinatal Urine Toxicology Testing to Guide Breastfeeding Initiation(Wolters Kluwer, 2021) Harris, Miriam; Joseph, Kathleen; Hoeppner, Bettina; Wachman, Elisha M.; Gray, Jessica R.; Saia, Kelley; Wakeman, Sarah; Bair-Merritt, Megan H.; Schiff, Davida M.; Emergency Medicine, School of MedicineObjective: National guidelines advise against breastfeeding for women who use nonprescribed substances in the third trimester. This reduces the number of women who are supported in breastfeeding initiation despite limited evidence on the prognostic value of third trimester substance use. We sought to examine the degree to which prenatal nonprescribed substance use is associated with non-prescribed use postpartum. Methods: Retrospective cohort study of pregnant women with opioid use disorder on methadone or buprenorphine between 2006 and 2015. Nonprescribed use was defined by a positive urine drug testing (UDT). Sensitivity, specificity, positive predictive value, and negative predictive value were calculated comparing 3 prenatal periods with postpartum UDT results. Generalized estimating equations were used to examine the extent to which prenatal nonprescribed use was associated with postpartum use. Results: Included were 545 deliveries by 503 women. Mean age was 28.3 years, 88% were White/non-Hispanic, 93% had public insurance, and 43% received adequate prenatal care. The predictive value of UDT's 90 to 31 days before delivery, 30 to 0 days before delivery, and at delivery showed low sensitivity (44, 26, 27%, respectively) and positive predictive value (36, 36, 56%, respectively), but higher negative predictive value (80, 85, and 78%, respectively), P-values all <0.05. In the final adjusted model, only nonprescribed use at delivery was significantly associated with postpartum nonprescribed use. Conclusions: Nonprescribed use at delivery was most strongly associated with postpartum use compared with earlier time periods currently prioritized in guidelines. In women with opioid use disorder prenatal UDT results alone are insufficient to guide breastfeeding decisions.Item Actionable recommendations in the Bright Futures child health supervision guidelines(Schattauer, 2014) Finnell, S.M.E.; Stanton, J.L.; Downs, S.M.; Department of Pediatrics, IU School of MedicineBACKGROUND: With the growing use of electronic health record systems, there is a demand for an electronic version of the leading American pediatric preventive care guideline, Bright Futures. As computer implementation requires actionable recommendations, it is important to assess to what degree Bright Futures meets criteria for actionability. OBJECTIVES: We aimed to 1) determine the number of actionable recommendations in the current edition of Bright Futures and 2) to recommend a specific format for representing an important class of guidelines in a way that better facilitates computer implementation. METHODS: We consolidated all action statements in Bright Futures into recommendations. We then used two dimensions (decidability and executability) in the Guideline Implementability Appraisal v 2.0 (GLIA) to determine the actionability of the recommendations. Decidability means the recommendation states precisely under what conditions to perform those actions. Executability means actions are stated specifically, unambiguously and in sufficient detail. The results were presented in a figure titled Service Interval Diagram (SID), describing actionable recommendations, age intervals during which they are applicable, and how frequently they should occur in that interval. RESULTS: We consolidated 2161 action items into 245 recommendations and identified 52 that were actionable (21%). Almost exclusively, these recommendations addressed screening, such as newborn metabolic screening, or child safety, such as car seat use. A limited number (n=13) of recommendations for other areas of anticipatory guidance were also actionable. No recommendations on child discipline, family function or mental health met our criteria for actionability. The SID representing these recommendations is presented in a figure. CONCLUSION: Only a portion of the Bright Futures Guidelines meets criteria for actionability. Substantial work lies ahead to develop most recommendations for anticipatory guidance into a computer implementable format.Item Barriers to guideline-concordant antibiotic use among inpatient physicians: A case vignette qualitative study(Wiley, 2016-03) Livorsi, D.; Comer, Amber R.; Matthias, Marianne S.; Perencevich, E.N.; Bair, M.J.; Department of Communication Studies, School of Liberal ArtsBACKGROUND: Greater adherence to antibiotic-prescribing guidelines may promote more judicious antibiotic use, which could benefit individual patients and society at large. OBJECTIVE: To assess physician knowledge and acceptance of antibiotic-prescribing guidelines through the use of case vignettes. DESIGN: We conducted semistructured interviews with 30 inpatient physicians. Participants were asked to respond to 3 hypothetical case vignettes: (1) a skin and soft tissue infection (SSTI), (2) suspected hospital-acquired pneumonia (HAP), and (3) asymptomatic bacteriuria (ASB). All participants received feedback according to guidelines from the Infectious Diseases Society of America (IDSA) and were asked to discuss their level of comfort with following these guidelines. SETTING: Two acute care teaching hospitals for adult patients. INTERVENTION: None. MEASUREMENTS: Data from transcribed interviews were analyzed using emergent thematic analysis. RESULTS: Participants were receptive to guidelines and believed they were useful. However, participants' responses to the case vignettes demonstrated that IDSA guideline recommendations were not routinely followed for SSTI, HAP, and ASB. We identified 3 barriers to guideline-concordant care: (1) physicians' lack of awareness of specific guideline recommendations; (2) tension between adhering to guidelines and the desire to individualize patient care; and (3) skepticism of certain guideline recommendations. CONCLUSIONS: Case vignettes may be useful tools to assess physician knowledge and acceptance of antibiotic-prescribing guidelines. Using case vignettes, we identified 3 barriers to following IDSA guidelines. Efforts to improve guideline-concordant antibiotic prescribing should focus on reducing such barriers at the local level.Item Clinical challenges in diagnosis and treatment of recurrent vulvovaginal candidiasis(Sage, 2022-09-08) Neal, Chemen M.; Martens, Mark G.; Obstetrics and Gynecology, School of MedicineVulvovaginal candidiasis is a common infection associated most often with the overgrowth of the fungal species Candida albicans. Although most women will have at least one episode of vulvovaginal candidiasis in their lifetime, some will experience recurrent infections. Recurrent vulvovaginal candidiasis can significantly impact quality of life, causing both physical and psychological symptoms, and poses a substantial financial burden for women and the health care system. Acute vulvovaginal candidiasis infections are often diagnosed symptomatically by clinicians or self-diagnosed by patients themselves; this can result in over- and underdiagnosis, as well as misdiagnosis, and has the potential to lead to ineffective treatment and incomplete infection resolution. Clinical diagnosis should include confirmatory laboratory tests, including microscopy and fungal culture, especially in women with a history of recurrent vulvovaginal candidiasis, who are more likely than women with vulvovaginal candidiasis to be infected with less-common Candida species or with azole-resistant strains. With proper diagnosis, most acute vulvovaginal candidiasis episodes can be successfully treated; however, women with recurrent vulvovaginal candidiasis may require long-term maintenance therapy. US-based guidelines recommend ⩽6 months of maintenance fluconazole treatment, but infection recurs in up to 50% of women treated. There are currently no US Food and Drug Administration–approved treatments for recurrent vulvovaginal candidiasis; however, several promising treatments for recurrent vulvovaginal candidiasis are in development.Item Clinical management guidelines for Friedreich ataxia: best practice in rare diseases(Springer Nature, 2022-11-12) Corben, Louise A.; Collins, Veronica; Milne, Sarah; Farmer, Jennifer; Musheno, Ann; Lynch, David; Subramony, Sub; Pandolfo, Massimo; Schulz, Jörg B.; Lin, Kim; Delatycki, Martin B.; Clinical Management Guidelines Writing Group; Medicine, School of MedicineBackground: Individuals with Friedreich ataxia (FRDA) can find it difficult to access specialized clinical care. To facilitate best practice in delivering healthcare for FRDA, clinical management guidelines (CMGs) were developed in 2014. However, the lack of high-certainty evidence and the inadequacy of accepted metrics to measure health status continues to present challenges in FRDA and other rare diseases. To overcome these challenges, the Grading of Recommendations Assessment and Evaluation (GRADE) framework for rare diseases developed by the RARE-Bestpractices Working Group was adopted to update the clinical guidelines for FRDA. This approach incorporates additional strategies to the GRADE framework to support the strength of recommendations, such as review of literature in similar conditions, the systematic collection of expert opinion and patient perceptions, and use of natural history data. Methods: A panel representing international clinical experts, stakeholders and consumer groups provided oversight to guideline development within the GRADE framework. Invited expert authors generated the Patient, Intervention, Comparison, Outcome (PICO) questions to guide the literature search (2014 to June 2020). Evidence profiles in tandem with feedback from individuals living with FRDA, natural history registry data and expert clinical observations contributed to the final recommendations. Authors also developed best practice statements for clinical care points that were considered self-evident or were not amenable to the GRADE process. Results: Seventy clinical experts contributed to fifteen topic-specific chapters with clinical recommendations and/or best practice statements. New topics since 2014 include emergency medicine, digital and assistive technologies and a stand-alone section on mental health. Evidence was evaluated according to GRADE criteria and 130 new recommendations and 95 best practice statements were generated. Discussion and conclusion: Evidence-based CMGs are required to ensure the best clinical care for people with FRDA. Adopting the GRADE rare-disease framework enabled the development of higher quality CMGs for FRDA and allows individual topics to be updated as new evidence emerges. While the primary goal of these guidelines is better outcomes for people living with FRDA, the process of developing the guidelines may also help inform the development of clinical guidelines in other rare diseases.Item Consensus clinical management guidelines for Alström syndrome(BMC, 2020-09-21) Tahani, Natascia; Maffei, Pietro; Dollfus, Hélène; Paisey, Richard; Valverde, Diana; Milan, Gabriella; Han, Joan C.; Favaretto, Francesca; Madathil, Shyam C.; Dawson, Charlotte; Armstrong, Matthew J.; Warfield, Adrian T.; Düzenli, Selma; Francomano, Clair A.; Gunay-Aygun, Meral; Dassie, Francesca; Marion, Vincent; Valenti, Marina; Leeson-Beevers, Kerry; Chivers, Ann; Steeds, Richard; Barrett, Timothy; Geberhiwot, Tarekegn; Medical and Molecular Genetics, School of MedicineAlström Syndrome (ALMS) is an ultra-rare multisystem genetic disorder caused by autosomal recessive variants in the ALMS1 gene, which is located on chromosome 2p13. ALMS is a multisystem, progressive disease characterised by visual disturbance, hearing impairment, cardiomyopathy, childhood obesity, extreme insulin resistance, accelerated non-alcoholic fatty liver disease (NAFLD), renal dysfunction, respiratory disease, endocrine and urologic disorders. Clinical symptoms first appear in infancy with great variability in age of onset and severity. ALMS has an estimated incidence of 1 case per 1,000,000 live births and ethnically or geographically isolated populations have a higher-than-average frequency. The rarity and complexity of the syndrome and the lack of expertise can lead to delayed diagnosis, misdiagnosis and inadequate care. Multidisciplinary and multiprofessional teams of experts are essential for the management of patients with ALMS, as early diagnosis and intervention can slow the progression of multi-organ dysfunctions and improve patient quality of life. These guidelines are intended to define standard of care for patients suspected or diagnosed with ALMS of any age. All information contained in this document has originated from a systematic review of the literature and the experiences of the authors in their care of patients with ALMS. The Appraisal of Guidelines for Research & Evaluation (AGREE II) system was adopted for the development of the guidelines and for defining the related levels of evidence and strengths of recommendations. These guidelines are addressed to: a) specialist centres, other hospital-based medical teams and staffs involved with the care of ALMS patients, b) family physicians and other primary caregivers and c) patients and their families.Item Considerations for the Utility of the CPIC Guideline for CYP2D6 Genotype and Codeine Therapy(Oxford University Press, 2015-05) Crews, Kristine R.; Caudle, Kelly E.; Dunnenberger, Henry M.; Sadhasivam, Senthilkumar; Skaar, Todd C.Item Diagnosis and Management of Uncomplicated Chlamydia trachomatis Infections in Adolescents and Adults: Summary of Evidence Reviewed for the 2021 Centers for Disease Control and Prevention Sexually Transmitted Infections Treatment Guidelines(Oxford University Press, 2022) Geisler, William M.; Hocking, Jane S.; Darville, Toni; Batteiger, Byron E.; Brunham, Robert C.; Medicine, School of MedicineTo prepare for the development of the 2021 Centers for Disease Control and Prevention (CDC) sexually transmitted infections treatment guidelines, the CDC convened a committee of expert consultants in June 2019 to discuss recent abstracts and published literature on the epidemiology, diagnosis, and management of sexually transmitted infections.This paper summarizes the key questions, evidence, and recommendations for the diagnosis and management of uncomplicated Chlamydia trachomatis (CT) infections in adolescents and adults that were reviewed and discussed for consideration in developing the guidelines. The evidence reviewed mostly focused on efficacy of doxycycline and azithromycin for urogenital, rectal, and oropharyngeal CT infection, CT risk factors in women, performance of CT nucleic acid amplification tests on self-collected meatal specimens in men, and performance of newer CT point-of-care tests.Item EAES and SAGES 2018 consensus conference on acute diverticulitis management: evidence-based recommendations for clinical practice(Springer Nature, 2019-09) Francis, Nader K.; Sylla, Patricia; Abou-Khalil, Maria; Arolfo, Simone; Berler, David; Curtis, Nathan J.; Dolejs, Scott C.; Garfinkle, Richard; Gorter-Stam, Marguerite; Hashimoto, Daniel A.; Hassinger, Taryn E.; Molenaar, Charlotte J. L.; Pucher, Philip H.; Schuermans, Valérie; Arezzo, Alberto; Agresta, Ferdinando; Antoniou, Stavros A.; Arulampalam, Tan; Boutros, Marylise; Bouvy, Nicole; Campbell, Kenneth; Francone, Todd; Haggerty, Stephen P.; Hedrick, Traci L.; Stefanidis, Dimitrios; Truitt, Mike S.; Kelly, Jillian; Ket, Hans; Dunkin, Brian J.; Pietrabissa, Andrea; Surgery, School of MedicineBACKGROUND: Acute diverticulitis (AD) presents a unique diagnostic and therapeutic challenge for general surgeons. This collaborative project between EAES and SAGES aimed to summarize recent evidence and draw statements of recommendation to guide our members on comprehensive AD management. METHODS: Systematic reviews of the literature were conducted across six AD topics by an international steering group including experts from both societies. Topics encompassed the epidemiology, diagnosis, management of non-complicated and complicated AD as well as emergency and elective operative AD management. Consensus statements and recommendations were generated, and the quality of the evidence and recommendation strength rated with the GRADE system. Modified Delphi methodology was used to reach consensus among experts prior to surveying the EAES and SAGES membership on the recommendations and likelihood to impact their practice. Results were presented at both EAES and SAGES annual meetings with live re-voting carried out for recommendations with < 70% agreement. RESULTS: A total of 51 consensus statements and 41 recommendations across all six topics were agreed upon by the experts and submitted for members' online voting. Based on 1004 complete surveys and over 300 live votes at the SAGES and EAES Diverticulitis Consensus Conference (DCC), consensus was achieved for 97.6% (40/41) of recommendations with 92% (38/41) agreement on the likelihood that these recommendations would change practice if not already applied. Areas of persistent disagreement included the selective use of imaging to guide AD diagnosis, recommendations against antibiotics in non-complicated AD, and routine colonic evaluation after resolution of non-complicated diverticulitis. CONCLUSION: This joint EAES and SAGES consensus conference updates clinicians on the current evidence and provides a set of recommendations that can guide clinical AD management practice.Item Equitable Global Representation in Cardiovascular Guidelines and Clinical Trials: Lacunae Remain(Elsevier, 2024-12-26) Bhat, Vivek; Fretz, Thomas J.; Kalra, Ankur; Medicine, School of Medicine