Browsing by Subject "Patient Selection"
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Item Open Access 10 Years with ICH E10: Choice of Control Groups.(Pharm Stat, 2011-09) Rockhold, Frank W; Enas, Gregory GItem Open Access A case study of inclusion of rural populations in research: Implications for science and health equity.(Clinical and translational science, 2024-08) Noonan, Devon; Lam, Wendy KK; Goodrich, James; Sullivan, Sydney; Bentley-Edwards, Keisha; Koeberl, Dwight; Palipana, Anushka; McClernon, F JosephPrior research highlights that rural populations have been historically underrepresented/excluded from clinical research. The primary objective of this study was to describe the inclusion of rural populations within our research enterprise using Clinical Research Management System demographic information at a large academic medical center in the Southeast. This was a cross-sectional study using participant demographic information for all protocols entered into our Clinical Research Management System between May 2018 and March 2021. Descriptive statistics were used to analyze the representation of rural and non-rural participants and demographic breakdown by age, sex, race, and ethnicity for our entire enterprise and at the state level. We also compared Material Community Deprivation Index levels between urban and rural participants. Results indicated that 19% of the research population was classified as rural and 81% as non-rural for our entire sample, and 17.5% rural and 82.5% urban for our state-level sample. There were significant differences in race, sex, and age between rural and non-rural participants and Material Community Deprivation Indices between rural and non-rural participants. Lessons learned and recommendations for increasing the inclusion of rural populations in research are discussed.Item Open Access Adult Congenital Heart Disease Care Provision: the Need for a Jack/Jackie of All Trades.(Progress in cardiovascular diseases, 2018-09) Krasuski, Richard AItem Open Access An evaluation of patient self-testing competency of prothrombin time for managing anticoagulation: pre-randomization results of VA Cooperative Study #481--The Home INR Study (THINRS).(Journal of thrombosis and thrombolysis, 2010-10) Dolor, Rowena J; Ruybalid, R Lynne; Uyeda, Lauren; Edson, Robert G; Phibbs, Ciaran; Vertrees, Julia E; Shih, Mei-Chiung; Jacobson, Alan K; Matchar, David B; THINRS Site InvestigatorsPrior studies suggest patient self-testing (PST) of prothrombin time (PT) can improve the quality of anticoagulation (AC) and reduce complications (e.g., bleeding and thromboembolic events). "The Home INR Study" (THINRS) compared AC management with frequent PST using a home monitoring device to high-quality AC management (HQACM) with clinic-based monitoring on major health outcomes. A key clinical and policy question is whether and which patients can successfully use such devices. We report the results of Part 1 of THINRS in which patients and caregivers were evaluated for their ability to perform PST. Study-eligible patients (n = 3643) were trained to use the home monitoring device and evaluated after 2-4 weeks for PST competency. Information about demographics, medical history, warfarin use, medications, plus measures of numeracy, literacy, cognition, dexterity, and satisfaction with AC were collected. Approximately 80% (2931 of 3643) of patients trained on PST demonstrated competency; of these, 8% (238) required caregiver assistance. Testers who were not competent to perform PST had higher numbers of practice attempts, higher cuvette wastage, and were less able to perform a fingerstick or obtain blood for the cuvette in a timely fashion. Factors associated with failure to pass PST training included increased age, previous stroke history, poor cognition, and poor manual dexterity. A majority of patients were able to perform PST. Successful home monitoring of PT with a PST device required adequate levels of cognition and manual dexterity. Training a caregiver modestly increased the proportion of patients who can perform PST.Item Open Access Chapter 6: assessing applicability of medical test studies in systematic reviews.(Journal of general internal medicine, 2012-06) Hartmann, KE; Matchar, DB; Chang, SUse of medical tests should be guided by research evidence about the accuracy and utility of those tests in clinical care settings. Systematic reviews of the literature about medical tests must address applicability to real-world decision-making. Challenges for reviews include: (1) lack of clarity in key questions about the intended applicability of the review, (2) numerous studies in many populations and settings, (3) publications that provide too little information to assess applicability, (4) secular trends in prevalence and the spectrum of the condition for which the test is done, and (5) changes in the technology of the test itself. We describe principles for crafting reviews that meet these challenges and capture the key elements from the literature necessary to understand applicability.Item Open Access Clinic variation in recruitment metrics, patient characteristics and treatment use in a randomized clinical trial of osteoarthritis management.(BMC musculoskeletal disorders, 2014-12) Allen, Kelli D; Bosworth, Hayden B; Chatterjee, Ranee; Coffman, Cynthia J; Corsino, Leonor; Jeffreys, Amy S; Oddone, Eugene Z; Stanwyck, Catherine; Yancy, William S; Dolor, Rowena JBackground
The Patient and PRovider Interventions for Managing Osteoarthritis (OA) in Primary Care (PRIMO) study is one of the first health services trials targeting OA in a multi-site, primary care network. This multi-site approach is important for assessing generalizability of the interventions. These analyses describe heterogeneity in clinic and patient characteristics, as well as recruitment metrics, across PRIMO study clinics.Methods
Baseline data were obtained from the PRIMO study, which enrolled n = 537 patients from ten Duke Primary Care practices. The following items were examined across clinics with descriptive statistics: (1) Practice Characteristics, including primary care specialty, numbers and specialties of providers, numbers of patients age 55+, urban/rural location and county poverty level; (2) Recruitment Metrics, including rates of eligibility, refusal and randomization; (3) Participants' Characteristics, including demographic and clinical data (general and OA-related); and (4) Participants' Self-Reported OA Treatment Use, including pharmacological and non-pharmacological therapies. Intraclass correlation coefficients (ICCs) were computed for participant characteristics and OA treatment use to describe between-clinic variation.Results
Study clinics varied considerably across all measures, with notable differences in numbers of patients age 55+ (1,507-5,400), urban/rural location (ranging from "rural" to "small city"), and proportion of county households below poverty level (12%-26%). Among all medical records reviewed, 19% of patients were initially eligible (10%-31% across clinics), and among these, 17% were randomized into the study (13%-21% across clinics). There was considerable between-clinic variation, as measured by the ICC (>0.01), for the following patient characteristics and OA treatment use variables: age (means: 60.4-66.1 years), gender (66%-88% female), race (16%-61% non-white), low income status (5%-27%), presence of hip OA (26%-68%), presence both knee and hip OA (23%-61%), physical therapy for knee OA (24%-61%) and hip OA (0%-71%), and use of knee brace with metal supports (0%-18%).Conclusions
Although PRIMO study sites were part of one primary care practice network in one health care system, clinic and patient characteristics varied considerably, as did OA treatment use. This heterogeneity illustrates the importance of including multiple, diverse sites in trials for knee and hip OA, to enhance the generalizability and evaluate potential for real-world implementation.Trial registration
Clinical trial registration number
NCT 01435109.Item Open Access Conducting research with racial/ethnic minorities: methodological lessons from the NIDA Clinical Trials Network.(The American journal of drug and alcohol abuse, 2011-09) Burlew, A Kathleen; Weekes, Jerren C; Montgomery, La'Trice; Feaster, Daniel J; Robbins, Michael S; Rosa, Carmen L; Ruglass, Lesia M; Venner, Kamilla L; Wu, Li-TzyMultiple studies in the National Institute on Drug Abuse Clinical Trials Network (CTN) demonstrate strategies for conducting effective substance abuse treatment research with racial/ethnic minorities (REMs).The objectives of this article are to describe lessons learned within the CTN to (1) enhance recruitment, retention, and other outcomes; (2) assess measurement equivalence; and (3) use data analytic plans that yield more information.This article includes background information and examples from multiple CTN studies on inclusion, measurement, and data analysis.Seven recommendations are included for conducting more effective research on REMs.Item Open Access Contemporary results of focal therapy for prostate cancer using cryoablation.(J Endourol, 2010-05) Mouraviev, Vladimir; Johansen, Truls Erik Bjerklund; Polascik, Thomas JThe concept of focal therapy is rapidly evolving and gaining popularity from both physician and patient perspectives. We review the rationale, candidate selection, and results of the first clinical studies of focal cryoablation for selected patients with low volume and low- to low-moderate-risk features of prostate cancer as an alternative to whole-gland treatment. In spite of improved understanding of the tumor biology of early stage disease, we currently have limited tools to select appropriate patients with low- to low-moderate risk unifocal or unilateral prostate cancer who may be amenable to focal therapy. From a technical point, a number of ablative treatment options for focal therapy are available, with cryoablation having the most clinical experience. Recently, several reports have been published from single and multi-institutional studies that discuss focal therapy as a reasonable balance between cancer control and quality-of-life outcomes. Retrospective pathologic data from large prostatectomy series, however, do not clearly reveal valid and reproducible criteria to select appropriate candidates for focal cryoablation because of the complexity of tumorigenesis in early stage disease. At this time, a more feasible option remains hemiablation of the prostate with reasonable certainty about the absence of clinically significant cancer lesion(s) on the contralateral side of the prostate based on three-dimensional transperineal prostate biopsy mapping studies. Minimally invasive, parenchyma-preserving cryoablation can be considered as a potential feasible option in the treatment armamentarium of early stage, localized prostate cancer in appropriately selected candidates. There is a need to further test this technique in randomized, multicenter clinical trials.Item Open Access Design, recruitment, logistics, and data management of the GEHA (Genetics of Healthy Ageing) project.(Exp Gerontol, 2011-11) Skytthe, A; Valensin, S; Jeune, B; Cevenini, E; Balard, F; Beekman, M; Bezrukov, V; Blanche, H; Bolund, L; Broczek, K; Carru, C; Christensen, K; Christiansen, L; Collerton, JC; Cotichini, R; de Craen, AJM; Dato, S; Davies, K; De Benedictis, G; Deiana, L; Flachsbart, F; Gampe, J; Gilbault, C; Gonos, ES; Haimes, E; Hervonen, A; Hurme, MA; Janiszewska, D; Jylhä, M; Kirkwood, TBL; Kristensen, P; Laiho, P; Leon, A; Marchisio, A; Masciulli, R; Nebel, A; Passarino, G; Pelicci, G; Peltonen, L; Perola, M; Poulain, M; Rea, IM; Remacle, J; Robine, JM; Schreiber, S; Scurti, M; Sevini, F; Sikora, E; Skouteri, A; Slagboom, PE; Spazzafumo, L; Stazi, MA; Toccaceli, V; Toussaint, O; Törnwall, O; Vaupel, JW; Voutetakis, K; Franceschi, C; GEHA consortiumIn 2004, the integrated European project GEHA (Genetics of Healthy Ageing) was initiated with the aim of identifying genes involved in healthy ageing and longevity. The first step in the project was the recruitment of more than 2500 pairs of siblings aged 90 years or more together with one younger control person from 15 areas in 11 European countries through a coordinated and standardised effort. A biological sample, preferably a blood sample, was collected from each participant, and basic physical and cognitive measures were obtained together with information about health, life style, and family composition. From 2004 to 2008 a total of 2535 families comprising 5319 nonagenarian siblings were identified and included in the project. In addition, 2548 younger control persons aged 50-75 years were recruited. A total of 2249 complete trios with blood samples from at least two old siblings and the younger control were formed and are available for genetic analyses (e.g. linkage studies and genome-wide association studies). Mortality follow-up improves the possibility of identifying families with the most extreme longevity phenotypes. With a mean follow-up time of 3.7 years the number of families with all participating siblings aged 95 years or more has increased by a factor of 5 to 750 families compared to when interviews were conducted. Thus, the GEHA project represents a unique source in the search for genes related to healthy ageing and longevity.Item Open Access Differences between chest pain observation service patients and admitted "rule-out myocardial infarction" patients.(Academic emergency medicine : official journal of the Society for Academic Emergency Medicine, 1997-07) Dallara, J; Severance, HW; Davis, B; Schulz, GObjective
To compare and contrast the patient characteristics of ED patients at low risk for acute cardiac ischemia who were assigned to a chest pain observation service vs those admitted to a monitored inpatient bed for "rule-out acute myocardial infarction" (R/O MI).Methods
This was a retrospective, cross-sectional comparison of adult patients considered at relatively low risk for cardiac ischemia and who were evaluated in 1 of 2 settings: a short-term observation service and an inpatient monitored bed. All patients had an ED final diagnosis of "chest pain," "R/O MI," or "unstable angina" during the 7-month study period. Demographic features and presenting clinical features were examined as a function of site of patient evaluation.Results
Of 531 study patients, 265 (50%) were assigned to the observation service. Younger age (OR = 1.75, 95% CI 1.26, 2.44, for each decrement of 20 years), the complaint of "chest pain" (OR = 2.35, 95% CI 1.34, 4.12), and the absence of prior known coronary artery disease (OR = 1.64, 95% CI 1.13, 2.38) were the principal independent factors associated with assignment to a chest pain observation service bed.Conclusions
Patients evaluated in a chest pain observation service appear to have different clinical characteristics than other individuals admitted to a monitored inpatient bed for "R/O MI." Investigators should address differences in clinical characteristics when making outcome comparisons between these 2 patient groups.Item Open Access Economic evaluation of access to musculoskeletal care: the case of waiting for total knee arthroplasty.(BMC Musculoskelet Disord, 2014-01-18) Mather, Richard C; Hug, Kevin T; Orlando, Lori A; Watters, Tyler Steven; Koenig, Lane; Nunley, Ryan M; Bolognesi, Michael PBACKGROUND: The projected demand for total knee arthroplasty is staggering. At its root, the solution involves increasing supply or decreasing demand. Other developed nations have used rationing and wait times to distribute this service. However, economic impact and cost-effectiveness of waiting for TKA is unknown. METHODS: A Markov decision model was constructed for a cost-utility analysis of three treatment strategies for end-stage knee osteoarthritis: 1) TKA without delay, 2) a waiting period with no non-operative treatment and 3) a non-operative treatment bridge during that waiting period in a cohort of 60 year-old patients. Outcome probabilities and effectiveness were derived from the literature. Costs were estimated from the societal perspective with national average Medicare reimbursement. Effectiveness was expressed in quality-adjusted life years (QALYs) gained. Principal outcome measures were average incremental costs, effectiveness, and quality-adjusted life years; and net health benefits. RESULTS: In the base case, a 2-year wait-time both with and without a non-operative treatment bridge resulted in a lower number of average QALYs gained (11.57 (no bridge) and 11.95 (bridge) vs. 12.14 (no delay). The average cost was $1,660 higher for TKA without delay than wait-time with no bridge, but $1,810 less than wait-time with non-operative bridge. The incremental cost-effectiveness ratio comparing wait-time with no bridge to TKA without delay was $2,901/QALY. When comparing TKA without delay to waiting with non-operative bridge, TKA without delay produced greater utility at a lower cost to society. CONCLUSIONS: TKA without delay is the preferred cost-effective treatment strategy when compared to a waiting for TKA without non-operative bridge. TKA without delay is cost saving when a non-operative bridge is used during the waiting period. As it is unlikely that patients waiting for TKA would not receive non-operative treatment, TKA without delay may be an overall cost-saving health care delivery strategy. Policies aimed at increasing the supply of TKA should be considered as savings exist that could indirectly fund those strategies.Item Open Access Effectiveness of spinal fusion versus structured rehabilitation in chronic low back pain patients with and without isthmic spondylolisthesis: a systematic review.(Spine, 2011-10) Wood, Kirkham B; Fritzell, Peter; Dettori, Joseph R; Hashimoto, Robin; Lund, Teija; Shaffrey, ChrisStudy design
Systematic review.Objective
To determine if the presence of isthmic spondylolisthesis modifies the effect of treatment (fusion vs. multidimensional supervised rehabilitation) in patients with chronic low back pain (CLBP).Summary of background data
Results of spinal surgery for CLBP are variable. It is unclear whether patients with CLBP and isthmic spondylolisthesis have more success with surgery versus a multidimensional supervised rehabilitation program when compared with those with CLBP but without spondylolisthesis.Methods
A systematic search was conducted in MEDLINE and the Cochrane Collaboration Library for articles published through January 2011. Randomized controlled trials (RCTs) were included that compared spine fusion versus multidimensional supervised rehabilitation in patients with and without isthmic spondylolisthesis. Standardized mean differences (SMDs) and risk differences were calculated for common outcomes, and then compared to determine potential heterogeneity of treatment effect. The final strength of the body of literature was expressed as "high," "moderate," or "low" confidence that the evidence reflects the true effect.Results
No studies were found that directly compared the two subgroups. Three RCTs compared fusion with supervised nonoperative care in patients with CLBP without isthmic spondylolisthesis; one RCT evaluated these treatments in patients with isthmic spondylolisthesis. There were study differences in patient characteristics, type of fusion, the nature of the rehabilitation, outcomes assessed, and length of follow-up. The SMDs for pain in favor of fusion were modest at 2 years for those without isthmic spondylolisthesis, but large in favor of fusion for those with isthmic spondylolisthesis compared with rehabilitation. Similarly, the SMDs for function in patients without isthmic spondylolisthesis compared with rehabilitation was small at 2 years, but appreciably higher in favor of fusion in patients with isthmic spondylolisthesis.Conclusion
The overall strength of evidence evaluating whether the presence of isthmic spondylolisthesis modifies the effect of fusion compared with rehabilitation patients with CLBP is "low." Fusion should be considered for patients with low back pain and isthmic spondylolisthesis who have failed nonoperative treatment.Clinical recommendations
We recommend considering fusion for patients with isthmic spondylolisthesis and lower back pain who have failed nonoperative treatment.Recommendation
Weak.Item Open Access Factors Associated with Mortality after Percutaneous Endoscopic Gastrostomy.(JSLS : Journal of the Society of Laparoendoscopic Surgeons, 2023-04) Lima, Diego Laurentino; Miranda, Luiz Eduardo Correia; Lima, Raquel Nogueira Cordeiro Laurentino; Romero-Velez, Gustavo; Chin, Ryan; Shadduck, Phillip P; Sreeramoju, PrashanthIntroduction
Percutaneous endoscopic gastrostomy (PEG) is a common procedure performed world-wide on patients with different comorbidities, with many indications and overall low morbidity. However, studies showed an elevated early mortality in patients undergoing PEG placement. In this systematic review, we review the factors associated with early mortality after PEG.Methods
The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed. The methodological index for nonrandomized studies (MINORS) score system was used to perform qualitative assessment of all included studies. Recommendations were summarized for predefined key items.Results
The search found 283 articles. A refined total of 21 studies were included; 20 studies cohort studies and 1 case-control study. For the cohort studies, MINORS score ranged from 7 to 12 out of 16. The single case-control study scored 17 out of 24. The number of study patients ranged from 272 to 181,196. Thirty-day mortality rate varied from 2.4% to 23.5%. Albumin, age, body mass index, C-reactive protein, diabetes mellitus, and dementia were the most frequently associated factors to early mortality in patients undergoing PEG placement. Five studies reported procedure related deaths. Infection was the most commonly reported complication of PEG placement.Conclusions
PEG tube insertion is a fast, safe and effective procedure, but is not free of complications and can have a high early mortality rate as demonstrated in this review. Patient selection should be a key factor and the identification of factors associated with early mortality is important in the elaboration of a protocol to benefit patients.Item Open Access Focal therapy in prostate cancer-report from a consensus panel.(J Endourol, 2010-05) de la Rosette, J; Ahmed, H; Barentsz, J; Johansen, T Bjerklund; Brausi, M; Emberton, M; Frauscher, F; Greene, D; Harisinghani, M; Haustermans, K; Heidenreich, A; Kovacs, G; Mason, M; Montironi, R; Mouraviev, V; de Reijke, T; Taneja, S; Thuroff, S; Tombal, B; Trachtenberg, J; Wijkstra, H; Polascik, TPURPOSE: To establish a consensus in relation to case selection, conduct of therapy, and outcomes that are associated with focal therapy for men with localized prostate cancer. MATERIAL AND METHODS: Urologic surgeons, radiation oncologists, radiologists, and histopathologists from North America and Europe participated in a consensus workshop on focal therapy for prostate cancer. The consensus process was face to face within a structured meeting, in which pertinent clinical issues were raised, discussed, and agreement sought. Where no agreement was possible, this was acknowledged, and the nature of the disagreement noted. RESULTS: Candidates for focal treatment should have unilateral low- to intermediate-risk disease with clinical stageItem Open Access Hospital response to a new case-based payment system in China: the patient selection effect.(Health policy and planning, 2024-05) Zhang, Xinyu; Tang, Shenglan; Wang, Ruixin; Qian, Mengcen; Ying, Xiaohua; Maciejewski, Matthew LProviders have intended and unintended responses to payment reforms, such as China's new case-based payment system, i.e. Diagnosis-Intervention Packet (DIP) under global budget, that classified patients based on the combination of principal diagnosis and procedures. Our study explores the impact of DIP payment reform on hospital selection of patients undergoing total hip/knee arthroplasty (THA/TKA) or with arteriosclerotic heart disease (AHD) from July 2017 to June 2021 in a large city. We used a difference-in-differences approach to compare the changes in patient age, severity reflected by the Charlson Comorbidity Index (CCI), and a measure of treatment intensity [relative weight (RW)] in hospitals that were and were not subject to DIP incentives before and after the DIP payment reform in July 2019. Compared with non-DIP pilot hospitals, trends in patient age after the DIP reform were similar for DIP and non-DIP hospitals for both conditions, while differences in patient severity grew because severity in DIP hospitals increased more for THA/TKA (P = 0.036) or dropped in non-DIP hospitals for AHD (P = 0.011) following DIP reform. Treatment intensity (measured via RWs) for AHD patients in DIP hospitals increased 5.5% (P = 0.015) more than in non-DIP hospitals after payment reform, but treatment intensity trends were similar for THA/TKA patients in DIP and non-DIP hospitals. When the DIP payment reform in China was introduced just prior to the pandemic, hospitals subject to this reform responded by admitting sicker patients and providing more treatment intensity to their AHD patients. Policymakers need to balance between cost containment and the unintended consequences of prospective payment systems, and the DIP payment could also be a new alternative payment system for other countries.Item Open Access Lopinavir/ritonavir monotherapy after virologic failure of first-line antiretroviral therapy in resource-limited settings.(AIDS, 2012-07-17) Bartlett, John A; Ribaudo, Heather J; Wallis, Carole L; Aga, Evgenia; Katzenstein, David A; Stevens, Wendy S; Norton, Michael R; Klingman, Karin L; Hosseinipour, Mina C; Crump, John A; Supparatpinyo, Khuanchai; Badal-Faesen, Sharlaa; Kallungal, Beatrice A; Kumarasamy, NagalingeswaranOBJECTIVE: To evaluate virologic response rates of lopinavir/ritonavir (LPV/r) monotherapy as second-line antiretroviral treatment (ART) among adults in resource-limited settings (RLSs). DESIGN: An open-label pilot study of LPV/r monotherapy in participants on first-line nonnucleoside reverse transcriptase inhibitor three-drug combination ART with plasma HIV-1 RNA 1000-200 000 copies/ml. METHODS: Participants were recruited from five sites in Africa and Asia within the AIDS Clinical Trials Group (ACTG) network. All participants received LPV/r 400/100 mg twice daily. The primary endpoint was remaining on LPV/r monotherapy without virologic failure at week 24. Participants with virologic failure were offered addition of emtricitabine and tenofovir (FTC/TDF) to LPV/r. RESULTS: Mutations associated with drug resistance were encountered in nearly all individuals screened for the study. One hundred and twenty-three participants were enrolled, and 122 completed 24 weeks on study. A high proportion remained on LPV/r monotherapy without virologic failure at 24 weeks (87%). Archived samples with HIV-1 RNA levels less than 400 copies/ml at week 24 (n=102) underwent ultrasensitive assay. Of these individuals, 62 had levels less than 40 copies/ml and 30 had levels 40-200 copies/ml. Fifteen individuals experienced virologic failure, among whom 11 had resistance assessed and two had emergent protease inhibitor mutations. Thirteen individuals with virologic failure added FTC/TDF and one individual added FTC/TDF without virologic failure. At study week 48, 11 of 14 adding FTC/TDF had HIV-1 RNA levels less than 400 copies/ml. CONCLUSION: In this pilot study conducted in diverse RLS, LPV/r monotherapy as second-line ART demonstrated promising activity.Item Open Access Lower likelihood of cardiac procedures after acute coronary syndrome in patients with human immunodeficiency virus/acquired immunodeficiency syndrome.(Medicine, 2018-02) Clement, Meredith E; Lin, Li; Navar, Ann Marie; Okeke, Nwora Lance; Naggie, Susanna; Douglas, Pamela SCardiovascular disease (CVD) is an increasing cause of morbidity and mortality in human immunodeficiency virus (HIV)-infected adults; however, this population may be less likely to receive interventions during hospitalization for acute coronary syndrome (ACS). The degree to which this disparity can be attributed to poorly controlled HIV infection is unknown.In this large cohort study, we used the National Inpatient Sample (NIS) to compare rates of cardiac procedures among patients with asymptomatic HIV-infection, symptomatic acquired immunodeficiency syndrome (AIDS), and uninfected adults hospitalized with ACS from 2009 to 2012. Multivariable analysis was used to compare procedure rates by HIV status, with appropriate weighting to account for NIS sampling design including stratification and hospital clustering.The dataset included 1,091,759 ACS hospitalizations, 0.35% of which (n = 3783) were in HIV-infected patients. Patients with symptomatic AIDS, asymptomatic HIV, and uninfected patients differed by sex, race, and income status. Overall rates of cardiac catheterization and revascularization were 53.3% and 37.4%, respectively. In multivariable regression, we found that relative to uninfected patients, those with symptomatic AIDS were less likely to undergo catheterization (odds ratio [OR] 0.48, confidence interval [CI] 0.43-0.55), percutaneous coronary intervention (OR 0.69, CI 0.59-0.79), and coronary artery bypass grafting (0.75, CI 0.61-0.93). No difference was seen for those with asymptomatic HIV relative to uninfected patients (OR 0.93, CI 0.81-1.07; OR 1.06, CI 0.93-1.21; OR 0.88, CI 0.72-1.06, respectively).We found that lower rates of cardiovascular procedures in HIV-infected patients were primarily driven by less frequent procedures in those with AIDS.Item Open Access Managing Prostate Cancer Surgical Patients during the COVID-19 Pandemic: A Brief Report of the Duke Cancer Institute's Initial Experience.(Oncology (Williston Park, N.Y.), 2020-05) Moul, Judd W; Chang, Andrew; Inman, Brant AThe coronavirus disease 2019 pandemic has rapidly placed tremendous stress on health systems around the world. In response, multiple health systems have postponed elective surgeries in order to conserve hospital beds and personal protective equipment, minimize patient traffic, and prevent unnecessary utilization and exposure of healthcare workers. The American College of Surgeons released the following statement on March 13, 2020: "Each hospital, health system and surgeon should thoughtfully review all scheduled elective procedures with a plan to minimize, postpone, or cancel electively scheduled operations, endoscopes, or other invasive procedures until we have passed the predicted inflection point in the exposure graph and can be confident that our health care infrastructure can support a potentially rapid and overwhelming uptick in critical patient care needs." In our state, North Carolina, Governor Roy Cooper requested that all hospitals postpone elective and non-urgent procedures and surgeries effective March 23, 2020.Item Open Access OnabotulinumtoxinA vs Sacral Neuromodulation on Refractory Urgency Urinary Incontinence in Women: A Randomized Clinical Trial.(JAMA, 2016-10-04) Amundsen, Cindy L; Richter, Holly E; Menefee, Shawn A; Komesu, Yuko M; Arya, Lily A; Gregory, W Thomas; Myers, Deborah L; Zyczynski, Halina M; Vasavada, Sandip; Nolen, Tracy L; Wallace, Dennis; Meikle, Susan FImportance: Women with refractory urgency urinary incontinence are treated with sacral neuromodulation and onabotulinumtoxinA with limited comparative information. Objective: To assess whether onabotulinumtoxinA is superior to sacral neuromodulation in controlling refractory episodes of urgency urinary incontinence. Design, Setting, and Participants: Multicenter open-label randomized trial (February 2012-January 2015) at 9 US medical centers involving 381 women with refractory urgency urinary incontinence. Interventions: Cystoscopic intradetrusor injection of 200 U of onabotulinumtoxinA (n = 192) or sacral neuromodulation (n = 189). Main Outcomes and Measures: Primary outcome, change from baseline mean number of daily urgency urinary incontinence episodes over 6 months, was measured with monthly 3-day diaries. Secondary outcomes included change from baseline in urinary symptom scores in the Overactive Bladder Questionnaire Short Form (SF); range, 0-100, higher scores indicating worse symptoms; Overactive Bladder Satisfaction questionnaire; range, 0-100; includes 5 subscales, higher scores indicating better satisfaction; and adverse events. Results: Of the 364 women (mean [SD] age, 63.0 [11.6] years) in the intention-to-treat population, 190 women in the onabotulinumtoxinA group had a greater reduction in 6-month mean number of episodes of urgency incontinence per day than did the 174 in the sacral neuromodulation group (-3.9 vs -3.3 episodes per day; mean difference, 0.63; 95% CI, 0.13 to 1.14; P = .01). Participants treated with onabotulinumtoxinA showed greater improvement in the Overactive Bladder Questionnaire SF for symptom bother (-46.7 vs -38.6; mean difference, 8.1; 95% CI, 3.0 to 13.3; P = .002); treatment satisfaction (67.7 vs 59.8; mean difference, 7.8; 95% CI, 1.6 to 14.1; P = .01) and treatment endorsement (78.1 vs 67.6; mean difference; 10.4, 95% CI, 4.3 to 16.5; P < .001) than treatment with sacral neuromodulation. There were no differences in convenience (67.6 vs 70.2; mean difference, -2.5; 95% CI, -8.1 to 3.0; P = .36), adverse effects (88.4 vs 85.1; mean difference, 3.3; 95% CI, -1.9 to 8.5; P = .22), and treatment preference (92.% vs 89%; risk difference, -3%; 95% CI, -16% to 10%; P = .49). Urinary tract infections were more frequent in the onabotulinumtoxinA group (35% vs 11%; risk difference, -23%; 95% CI, -33% to -13%; P < .001). The need for self-catheterization was 8% and 2% at 1 and 6 months in the onabotulinumtoxinA group. Neuromodulation device revisions and removals occurred in 3%. Conclusions and Relevance: Among women with refractory urgency urinary incontinence, treatment with onabotulinumtoxinA compared with sacral neuromodulation resulted in a small daily improvement in episodes that although statistically significant is of uncertain clinical importance. In addition, it resulted in a higher risk of urinary tract infections and need for transient self-catheterizations.Item Open Access Paravertebral Block for Inguinal Herniorrhaphy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.(Anesth Analg, 2015-08) Law, Lawrence Siu-Chun; Tan, Mingjuan; Bai, Yaowu; Miller, Timothy E; Li, Yi-Ju; Gan, Tong-JooBACKGROUND: Paravertebral block (PVB) is a safe and effective anesthetic technique for thoracotomy and mastectomy. However, no systematic review or meta-analysis has focused on PVB for inguinal herniorrhaphy. Our study compares PVB with general anesthesia/systemic analgesia, neuraxial blocks, and other peripheral nerve blocks. METHODS: We analyzed 14 randomized controlled trials from PubMed, MEDLINE, CENTRAL, EMBASE, and CINAHL up to February 2015, without language restriction, comparing PVB under sedation with general anesthesia/systematic analgesia (135 vs 133 patients), neuraxial blocks (191 vs 186 patients), and other peripheral nerve blocks (119 vs 117 patients). We investigated pain scores, consumption of postoperative analgesia, incidence of postoperative nausea and vomiting (PONV), length of hospital stay, postanesthesia care unit bypassing rate, time to perform blocks, intraoperative hemodynamics, and incidence of urinary retention. Joint hypothesis testing was adopted for pain and analgesics, PONV, and hemodynamic variables. All analyses were performed with RevMan 5.2.11 (Cochrane Collaboration, Copenhagen). Hartung-Knapp-Sidik-Jonkman method was used for post hoc testing. RESULTS: PVB reduced PONV (nausea: risk ratio [RR] = 0.22; 95% confidence interval [CI], 0.05-0.93; numbers needed to treat [NNT] = 4.5; I = 15% and vomiting: RR = 0.15; 95% CI, 0.03-0.76; NNT = 8.3; I = 0%) compared with general anesthesia/systematic analgesia (quality of evidence [QoE]: high). Compared with neuraxial blocks, PVB resulted in less postoperative nausea (RR = 0.34 [95% CI, 0.13-0.91], NNT = 8.3, I = 0%) and urinary retention (RR = 0.14 [95% CI, 0.05-0.42], NNT = 7.4, I = 0%) than neuraxial blocks (QoE: high). More time was needed to perform PVB than neuraxial blocks (standardized mean difference = 1.90 [95% CI, 0.02-3.77], I = 92%; mean difference = 5.33 minutes; QoE: moderate). However, the available data could not reject the null hypothesis of noninferiority on all pain scores and analgesic requirements for both PVB versus general anesthesia/systematic analgesia and PVB versus neuraxial blocks (QoE: low), as well as on hemodynamic outcomes for PVB versus neuraxial blocks (QoE: moderate). Our systematic review showed that PVB decreased postoperative pain scores and analgesic requirement as compared with ilioinguinal block and transversus abdominis plane block. CONCLUSIONS: This meta-analysis shows that PVB provides an anesthesia with fewer undesirable effects for inguinal herniorrhaphy. The choice between general anesthesia/systematic analgesia, neuraxial blocks, PVB, and other peripheral nerve blocks should be based on time available to perform the block and a complete coverage over the relevant structures by the blocks.