Browsing by Author "Slaven, James"

Now showing 1 - 10 of 21
  • Thumbnail Image
    Item
    A pilot study of ADRA2A genotype association with doses of dexmedetomidine for sedation in pediatric patients
    (Wiley, 2022) Gallaway, Katherine A.; Skaar, Skaar; Biju, Ashwin; Slaven, James; Tillman, Emma M.
    Study objective: Dexmedetomidine is titrated to achieve sedation in the pediatric and cardiovascular intensive care units (PICU and CVICU). In adults, dexmedetomidine response has been associated with an ADRA2A polymorphism (rs1800544); CC genotype is associated with an increased sedative response compared with GC and GG. To date, this has not been studied in children. Design: We conducted a pilot study to determine whether ADRA2A genotype is associated with dexmedetomidine dose in children. Measurements and main results: Forty intubated PICU or CVICU patients who received dexmedetomidine as a continuous infusion for at least 2 days were genotyped for ADRA2A with a custom-designed TaqMan® Assay. Ten (25%) subjects were wildtype (GG), 15 (37.5%) were heterozygous (GC), and 15 (37.5%) were homozygous (CC) variant. The maximum dexmedetomidine doses (mCg/kg/h) were not different between genotype groups CC (1, 0.3-1.2), GC (1, 0.3-1.3), and GG (0.8, 0.3-1.2), (p = 0.37); neither were mean dexmedetomidine doses for these respective genotype groups 0.68 (0.24-1.07), 0.72 (0.22-0.98), 0.58 (0.3-0.94), (p = 0.67). Conclusions: These findings did not confirm the results from adult studies where ADRA2A polymorphisms correlate with dexmedetomidine response, therefore highlighting the need for pediatric studies to validate PGx findings in adults prior to implementation in pediatrics.
  • Thumbnail Image
    Item
    Confidence Intervals for Asbestos Fiber Counts: Approximate Negative Binomial Distribution
    (Oxford University Press, 2017-03-01) Bartley, David; Slaven, James; Harper, Martin; Biostatistics, School of Public Health
    The negative binomial distribution is adopted for analyzing asbestos fiber counts so as to account for both the sampling errors in capturing only a finite number of fibers and the inevitable human variation in identifying and counting sampled fibers. A simple approximation to this distribution is developed for the derivation of quantiles and approximate confidence limits. The success of the approximation depends critically on the use of Stirling’s expansion to sufficient order, on exact normalization of the approximating distribution, on reasonable perturbation of quantities from the normal distribution, and on accurately approximating sums by inverse-trapezoidal integration. Accuracy of the approximation developed is checked through simulation and also by comparison to traditional approximate confidence intervals in the specific case that the negative binomial distribution approaches the Poisson distribution. The resulting statistics are shown to relate directly to early research into the accuracy of asbestos sampling and analysis. Uncertainty in estimating mean asbestos fiber concentrations given only a single count is derived. Decision limits (limits of detection) and detection limits are considered for controlling false-positive and false-negative detection assertions and are compared to traditional limits computed assuming normal distributions.
  • Thumbnail Image
    Item
    Design and methods of the Care Management for the Effective Use of Opioids (CAMEO) trial
    (Elsevier, 2021-07) Bushey, Michael A.; Slaven, James; Outcalt, Samantha D.; Kroenke, Kurt; Kempf, Carol; Froman, Amanda; Sargent, Christy; Baecher, Brad; Zillich, Alan; Damush, Teresa M.; Saha, Chandan; French, Dustin D.; Bair, Matthew J.; Medicine, School of Medicine
    Low back pain is the most common pain condition seen in primary care, with the most common treatment being analgesic medications, including opioids. A dramatic increase in opioid prescriptions for low back pain over the past few decades has led to increased non-medical use and opioid overdose deaths. Cognitive behavioral therapy (CBT) for chronic pain is an evidence-based non-pharmacological treatment for pain with demonstrated efficacy when delivered using collaborative care models. No previous studies have tested CBT compared to analgesic optimization that includes opioid management in primary care. This paper describes the study design and methods of the CAre Management for the Effective use of Opioids (CAMEO) trial, a 2-arm, randomized comparative effectiveness trial in seven primary care clinics. CAMEO enrolled 261 primary care veterans with chronic (6 months or longer) low back pain of at least moderate severity who were receiving long-term opioid therapy and randomized them to either nurse care management focused on analgesic treatment and optimization (MED) or cognitive behavioral therapy (CBT). All subjects undergo comprehensive outcome assessments at baseline, 3, 6, 9, and 12 months by interviewers blinded to treatment assignment. The primary outcome is pain severity and interference, measured by the Brief Pain Inventory (BPI) total score. Secondary outcomes include health-related quality of life, fatigue, sleep, functional improvement, pain disability, pain beliefs, alcohol and opioid problems, depression, anxiety, and stress.
  • No Thumbnail Available
    Item
    Development Of A Brief Measure Of Communication Quality: The 5- And 10-Item Family Inpatient Communication Surveys
    (Oxford University Press, 2022) Burke, Emily; Slaven, James; Taylor, Tracy; Monahan, Patrick; Sachs, Greg; Torke, Alexia; Biostatistics and Health Data Science, Richard M. Fairbanks School of Public Health
    Communication quality between clinical care teams and families impacts important outcomes like satisfaction, depression, and anxiety. Assessment tools must be efficient and reliable to be useful in the clinical environment. We report the development of 5 and 10-item versions of the validated 30-item Family Inpatient Communication Survey (FICS). Data were from 364 surrogate decision makers (SDMs) for incapacitated older adults in the ICU. Most SDMs were adult children (66.8%). SDMs were 70.9% female, 68.9% white, with a mean age of 58.3. Exploratory factor analysis revealed high internal reliability for the single-factor FICS5 (α= .88) and two-factor FICS10 (α= .93). The FICS10 reliably measures two subscales: information (α= .91) and emotional support (α=.81). Good discriminant and predictive validity were demonstrated when comparing total scores to outcomes at 6-8 weeks after hospital discharge, including anxiety (correlation coefficient (ρ)= -.13; p=.0234 ), depression (ρ =-.15; p=.0076), decision regret (ρ =--.15; p=.0066), and satisfaction (ρ =-..48; p<.0001). Repeating analysis with a new sample (n=188) revealed similar results with Cronbach’s alpha ranging from .81 to .93. The FICS5 revealed significant associations (p<.05) at 6-8 weeks after discharge with distress (-.22), while the FICS10 demonstrated significant associations with distress (-.28), anxiety (-.20), depression (-.19) and decision regret (-.27). Confirmatory factor analysis indicated adequate fit (CFI: FICS5= .994, FICS10= .994; RMSEA: FICS5= .093, FICS10= .103). The FICS provides clinicians and interventionists with a reliable, low burden tool to evaluate communication quality and respond quickly, which could impact satisfaction and other important outcomes for patients and families.
  • Thumbnail Image
    Item
    Effect of CPAP on airway reactivity and airway inflammation in children with moderate-severe asthma
    (Wiley, 2019-04) Praca, Eduardo; Jalou, Hasnaa; Krupp, Nadia; Delecaris, Angela; Hatch, Joseph; Slaven, James; Gunst, Susan J.; Tepper, Robert S.; Biostatistics, School of Public Health
    BACKGROUND AND OBJECTIVE: Asthma is characterized by airway hyperreactivity and airway inflammation. We previously demonstrated that adults with mild well-controlled asthma exhibited a marked decrease in airway reactivity (PC20 increased >2-fold) after using nocturnal continuous positive airway pressure (CPAP) for 1 week. If CPAP produces a similar suppression of airway reactivity in children with moderate-severe asthma, who require chronic use of corticosteroids, then this non-pharmacological therapy might provide a beneficial alternative or supplemental therapy in these subjects. METHODS: Children aged 8-17 years with moderate-severe asthma were treated with 4 weeks of nocturnal CPAP (8-10 cm H2 O) or sham CPAP (<2 cm H2 O). Adherence was monitored with a modem installed in the equipment or by memory cards. Airway reactivity, assessed by methacholine bronchial challenge, was measured prior to and following treatment. RESULTS: The percentage of subjects adherent to treatment was similar in both groups (19/27 CPAP vs 19/28 sham, ~70%). There was a tendency for PC20 to increase with treatment in both groups (3.0-5.3 mg/mL CPAP vs 3.2 to 4.3 mg/mL sham, P = 0.083); however, the change did not differ significantly between groups (P = 0.569). CONCLUSION: We found that the 4-week treatment with nocturnal CPAP did not produce a twofold suppression of airway reactivity in children with moderate-severe asthma.
  • Thumbnail Image
    Item
    EUS pancreatic function testing and dynamic pancreatic duct evaluation for the diagnosis of exocrine pancreatic insufficiency and chronic pancreatitis
    (Elsevier, 2020) DeWitt, John M.; Al-Haddad, Mohammad A.; Easler, Jeffrey J.; Sherman, Stuart; Slaven, James; Gardner, Timothy B.; Medicine, School of Medicine
    Background and Aims EUS and endoscopic pancreatic function tests (ePFTs) may be used to diagnose minimal- change chronic pancreatitis (MCCP). The impact of evaluation for exocrine pancreatic insufficiency (EPI) and real-time assessment of EUS changes after intravenous secretin on the clinical diagnosis of MCCP is unknown. Methods Patients with suspected MCCP underwent baseline EUS assessment of the pancreatic parenchyma and measurement of the main pancreatic duct (B-MPD) in the head, body, and tail. Human secretin 0.2 μg/kg IV was given followed 4, 8, and 12 minutes later by repeat MPD (S-MPD) measurements. Duodenal samples at 15, 30, and 45 minutes were aspirated for bicarbonate concentration. Endoscopists rated the percent clinical likelihood of CP: (1) before secretin; (2) after secretin but before aspiration; and (3) after bicarbonate results. Results 145 consecutive patients (mean age 44±13 years; 98F) were diagnosed with EPI (n=32; 22%). S-MPD/B-MPD ratios in the tail 4 and 8 minutes after secretin were higher in the group with normal exocrine function. Ratios at other times, locations and duodenal fluid volumes were similar between the 2 groups. A statistically significant change in the median percent likelihood of CP was noted after secretin in all groups. The sensitivity and specificity of EPI for the EUS diagnosis of CP (≥5 criteria) were 23.4% (95% CI, 12.3-38.0) and 78.6% (95% CI, 69.1-86.2), respectively. Conclusion Real-time EUS findings and ePFTs have a significant impact on the clinical assessment of MCCP. The diagnosis of EPI shows poor correlation with the EUS diagnosis of MCCP.
  • Thumbnail Image
    Item
    Failure Mode Analysis of the Endologix Endograft
    (Elsevier, 2016-09) Lemmon, Gary W.; Motaganahalli, Rahgu L.; Chang, Tiffany; Slaven, James; Aumiller, Ben; Kim, Bradford J.; Dalsing, Michael C.; Department of Surgery, IU School of Medicine
    Objective Type III (T-III) endoleaks following endovascular aneurysm repair (EVAR) remain a major concern. Our center experienced a recent concentration of T-III endoleaks requiring elective and emergency treatment and prompted our review of all EVAR implants over a 40-month period from April 2011 until August 2014. This report represents a single center experience with T-III endoleak management with analysis of factors leading to the T-III-related failure of EVAR. Methods A retrospective review of all the operative reports, medical records, and computed tomography scans were reviewed from practice surveillance. Using Society for Vascular Surgery aneurysm reporting standards, we analyzed the morphology of the aneurysms before and after EVAR implant using computed tomography. Index procedure and frequency of reinterventions required to maintain aneurysm freedom from rupture were compared across all devices using SAS v 9.4 (SAS Institute, Inc, Cary, NC). Major adverse events (MAEs) requiring secondary interventions for aneurysm treatment beyond primary implant were analyzed for methods of failure. Aneurysm morphology of patients requiring EVAR was compared across all endograft devices used for repair. For purposes of MAE analysis, patients receiving Endologix (ELX) endograft were combined into group 1; Gore, Cook, and Medtronic endograft patients were placed into group 2. Results Overall, technical success and discharge survival were achieved in 97.3% and 98% of patients regardless of device usage. There was no significant device related difference identified between patient survival or freedom from intervention. MAEs involving aneurysm treatment were over seven-fold more frequent with ELX (group 1) vs non-ELX (group 2) endografts (P < .01). Group 1 patients with aneurysm diameters larger than 65 mm were associated with a highly significant value for development of a T-III endoleak (odds ratio, 11.16; 95% confidence interval, 2.17, 57.27; P = .0038). Conclusions While EVAR technical success and survival were similar across all devices, ELX devices exhibited an unusually high incidence of T-III endoleaks when implanted in abdominal aortic aneurysms with a diameter of more than 65 mm. Frequent reinterventions were required for Endologix devices for prevention of aneurysm rupture due to T-III endoleaks.
  • Thumbnail Image
    Item
    Feasibility Of Ecological Momentary Assessment Of Surrogates For Cognitively Impaired Icu Patients: A Pilot Study
    (Oxford University Press, 2022) Taylor, Tracy; Burke, Emily; Slaven, James; Pfeffer, Bruce; Varner Perez, Shelley; Banks, Sarah; Torke, Alexia; Biostatistics and Health Data Science, Richard M. Fairbanks School of Public Health
    We explore the feasibility of ecological momentary assessment (EMA) with surrogate decision makers (SDMs) of critically ill hospitalized adults, to obtain in-the-moment participant-reported data. In this small pilot, 23 SDMs were approached. 82.6% were white, 53.9% were female, and 53.9% were 55 years and older. 25% were spouse or partner, 25% were adult children, 30% were parents, and 20% were other relations. Average ICU length of stay was 13.46 days (range 1.73-77.79). 13 SDMs enrolled (56.52%). Using Twilio, an automated text was sent to SDMs containing a secure link to the surveys. Up to five questions about anxiety, depression, distress, communication, and spiritual well-being were sent up to twice per day. Most participants (84.62%) completed EMA surveys for 5 or more days. Most SDMs stated that the surveys were not burdensome. Of those who declined participation (n= 10), accessibility to a smartphone, stress, and availability to complete texted surveys were noted as barriers to participation. The data suggest that EMA is a valuable tool to inform clinical interventionists and care providers interacting with SDMs. Future research will assess EMA with a larger group of SDMs, utilizing questions that help identify gaps in communication and opportunities to provide support to SDMs. Although surrogates are often under high stress in the ICU setting, they are willing to provide real-time EMA feedback on their experiences. EMA can provide a “just in time” option for research and clinical intervention that focuses on bridging gaps that may contribute to better outcomes for SDMs.
  • Thumbnail Image
    Item
    Glutathione-S-transferase P1 may predispose children to a decline in pulmonary function after stem cell transplant
    (Wiley, 2017-07) Stark, Julie; Renbarger, Jamie; Slaven, James; Yu, Zhangsheng; Then, Jenny; Skiles, Jodi; Davis, Stephanie; Pediatrics, School of Medicine
    RATIONALE: Pulmonary complications after hematopoietic stem cell transplant (SCT) are associated with increased mortality. Genetic markers for those at risk for pulmonary impairment post-SCT have not been widely investigated. METHODS: Forty-nine patients were retrospectively selected from a single institution's biorepository with linked clinical data. All subjects performed pre-SCT PFTs. Genotyping was conducted using the Infinium Exome-24 BeadChip. Four single nucleotide polymorphisms (SNPs) were selected (rs1800871, rs1695, rs1800629, rs12477314) and evaluated for association with PFT parameters as change over time from baseline. Associations between SNPs and PFT parameters were assessed and adjusted for the following confounding variables: age, gender, and race. RESULTS: Using the recessive genetic model, patients with one or two minor alleles for the glutathione S-transferase P1 (GSTP1) SNP rs1695 had a lower decline in FEV1 and FEF25-75 at 1-year post-SCT compared to patients who were homozygous for the ancestral allele (adjusted P-values <0.01 and 0.02, respectively). No other SNPs were significantly associated with other PFT parameters. CONCLUSIONS: Our findings suggest that GSTP1 genotype may be associated with lung function during the first year post-SCT. Identifying and investigating genes that predispose patients to pulmonary complications after SCT may allow for more personalized patient management based on pre-emptive genetic testing. The glutathione S-transferase gene merits further investigation.
  • Thumbnail Image
    Item
    Impact of the COVID-19 Pandemic on Cystic Fibrosis Pulmonary Exacerbations
    (Indiana University, 2020) Patel, Shreya; Thompson, Misty; Slaven, James; Ren, Clement L.; Pediatrics, School of Medicine