An Evaluation of the Kansas Bioscience Authority: Economic Impact Measures

In the fall of 2011, the Kansas Bioscience Authority (KBA) requested that the University of Kansas Center for Science, Technology & Economic Policy at the Institute for Policy & Social Research provide a review of KBA’s Direct Outcomes Description and Measurement Policy. This policy informs KBA's collection of economic impact data and frames KBA’s policies more generally in light of technology evaluation. This report responds to KBA's request and addresses the following topics: 1) general challenges of technology evaluation; 2) the scope of KBA’s technology programs; 3) the contributions of KBA’s current measures to overall program evaluation; 4) measures that might be added or enhanced in the future; and 5) a comparison of this review to other efforts to evaluate KBA. This report discusses the inherent difficulty of measuring long‐term scientific investments with short‐term indicators of future economic impact. KBA has several programs designed to increase bioscience research, foster commercial development, and attract new ventures to the state of Kansas. Each of these activities requires different metrics to evaluate its overall impact. We reviewed these metrics and compared them to those being collected by similar state agencies as well as the federal STAR METRICS program. Our review shows that KBA collects more metrics than agencies reviewed in other states. KBA also collects many of the indicators used in the federal STAR METRICS program. We recommend that KBA enhance its measures by including additional STAR METRICS measures such as patent citations, scientific publications, and workforce development indicators including students trained in bioscience on KBA funded projects. Although, KBA has been reviewed on two previous occasions, this report provides new information on the quality of the economic impact data they collect. Overall, we find that KBA collects a comprehensive set of outcome measures that span the scope of KBA’s mission and provide the basis for understanding the economic impact of their scientific investments

A Randomized, Controlled, Phase 2 Study of Maralixibat in the Treatment of Itching Associated With Primary Biliary Cholangitis.

Primary biliary cholangitis (PBC) is typically associated with elevated serum bile acid levels and pruritus, but pruritus is often refractory to treatment with existing therapies. This phase 2 study assessed the efficacy and safety of maralixibat, a selective, ileal, apical, sodium-dependent, bile acid transporter inhibitor, in adults with PBC and pruritus. Adults with PBC and pruritus who had received ursodeoxycholic acid (UDCA) for ≥6 months or were intolerant to UDCA were randomized 2:1 to maralixibat (10 or 20 mg/day) or placebo for 13 weeks in combination with UDCA (when tolerated). The primary outcome was change in Adult Itch Reported Outcome (ItchRO™) average weekly sum score (0, no itching; 70, maximum itching) from baseline to week 13/early termination (ET). The study enrolled 66 patients (maralixibat [both doses combined], n = 42; placebo, n = 24). Mean ItchRO™ weekly sum scores decreased from baseline to week 13/ET with maralixibat (-26.5; 95% confidence interval [CI], -31.8, -21.2) and placebo (-23.4; 95% CI, -30.3, -16.4). The difference between groups was not significant (P = 0.48). In the maralixibat and placebo groups, adverse events (AEs) were reported in 97.6% and 70.8% of patients, respectively. Gastrointestinal disorders were the most frequently reported AEs (maralixibat, 78.6%; placebo, 50.0%). Conclusion: Reductions in pruritus did not differ significantly between maralixibat and placebo. However, a large placebo effect may have confounded assessment of pruritus. Lessons learned from this rigorously designed and executed trial are indispensable for understanding how to approach trials assessing pruritus as the primary endpoint and the therapeutic window of bile acid uptake inhibition as a therapeutic strategy in PBC

The incidence of deep vein thrombosis detected by routine surveillance ultrasound in neurosurgery patients receiving dual modality prophylaxis.

The optimal method of thromboprophylaxis and the value of screening ultrasonography for detection of deep venous thrombosis (DVT) in neurosurgery patients remains unclear. The goal of this study was to determine the incidence of DVT in neurosurgical patients who, by hospital protocol, receive surveillance ultrasonography of the lower extremities twice weekly, in addition to prophylaxis with unfractionated heparin and external pneumatic compression sleeves. A retrospective review of 7,298 ultrasound studies carried out on 2,593 patients over 4 years at a university neurosurgical hospital was conducted. There was a 7.4% incidence of proximal lower extremity DVT and a 9.7% total incidence including distal DVT. A greater number of distal DVTs were detected with the implementation of whole-leg ultrasonography in the last 2 years of observation. Chart review of 237 patients diagnosed with DVT demonstrated an admitting diagnosis of subarachnoid hemorrhage in nearly half of the patients. The median hospital length of stay for DVT patients was 18 days. Institutional control data demonstrated non-ruptured aneurysm and cerebrovascular anomalies to be the leading reason for admission, followed closely by subarachnoid hemorrhage. The hospital protocol of biweekly screening ultrasound and dual modality prophylaxis for neurosurgery patients resulted in a proximal DVT incidence consistent with that demonstrated by previous studies of standardized dual modality prophylaxis, and higher than that demonstrated in previous studies that employed ultrasound screening protocols

Optimal technical management of stump closure following distal pancreatectomy: a retrospective review of 215 cases.

BACKGROUND: Pancreatic fistula (PF) is a major source of morbidity following distal pancreatectomy (DP). Our aim was to identify risk factors related to PF following DP and to determine the impact of technique of transection and stump closure. METHODS: We performed a retrospective review of 215 consecutive patients who underwent DP. Perioperative and postoperative data were collected and analyzed with attention to PF as defined by the International Study Group of Pancreatic Fistula. RESULTS: PF developed in 36 patients (16.7%); fistulas were classified as Grade A (44.4%), B (44.4%), or C (11.1%). The pancreas was transected with stapler (n = 139), cautery (n = 70), and scalpel (n = 3). PF developed in 19.8% of remnants which were stapled/oversewn and 27.7% that were stapled alone (p = 0.4). Of the 69 pancreatic remnants transected with cautery and oversewn, a fistula developed in 4.3% (p = 0.004 compared to stapled/oversewn; p = 0.006 compared to stapled/not sewn). The median length of postoperative hospital stay was significantly increased in patients who developed PF (10 vs. 6 days, p = 0.002) CONCLUSION: The method of transection and management of the pancreatic remnant plays a critical role in the formation of PF following DP. This series suggests that transection using electrocautery followed by oversewing of the pancreatic remnant has the lowest risk of PF

Impact of Obesity on Perioperative Morbidity and Mortality Following Pancreaticoduodenectomy

Background: Obesity has been implicated as a risk factor for perioperative and postoperative complications. The aim of this study was determine the impact of obesity on morbidity and mortality in patients undergoing pancreaticoduodenectomy (PD). Study Design: Between January 2000 and July 2007, 262 patients underwent PD at Thomas Jefferson University Hospital (TJUH), of whom 240 had complete data, including body mass index (BMI) for analysis. Data on BMI, preoperative parameters, operative details, and post-operative course were collected. Patients were categorized as obese (BMI \u3e30 kg/m2), overweight (25≤BMI\u3c30), or normal weight (BMI\u3c25). Complications were graded according to previous published scales. Other endpoints included length of postoperative hospital stay, blood loss, and operative duration. Analyses were performed using univariate and multivariable models. Results: There were 103 (42.9%) normal weight, 71 (29.6%) overweight and 66 (27.5%) obese patients. There were 5 perioperative deaths (2.1%) with no differences across BMI categories. A significant difference in median operative duration and blood loss between obese and normal weight patients was identified (439vs. 362.5minutes, p= 0.0004; 650 vs. 500 ml, p=0.0139). Furthermore, median length of stay was marginally significantly longer for by BMI (9.5 vs. 8 days, p=0.095). While there were no significant differences in superficial wound infections, obese patients did have an increased rate of serious complications compared to normal weight patients (24.2% vs. 13.6%, respectively; p=0.10). Conclusions: Obese patients undergoing PD have a significantly increased blood loss and longer operative time, but do not have a significantly increased length of postoperative hospital stay or rate of serious complications. These findings should be considered when assessing patients for operation and when counseling patients regarding operative risk, but do not preclude obese individuals from undergoing definitive pancreatic surgery

Development of GERAS DANcing for Cognition and Exercise (DANCE) : a feasibility study

Background: Dance is a mind-body activity of purposeful rhythmic movement to music. There is growing interest in using dance as a form of cognitive and physical rehabilitation. This manuscript describes the development of GERAS DANcing for Cognition and Exercise (DANCE) and evaluates its feasibility in older adults with cognitive and mobility impairments. Methods: The progressive dance curricula were delivered for 15 weeks (1-h class; twice weekly). Participants were eligible if they were community-dwelling older adults aged 60+ with early cognitive or mobility impairment able to follow three-step commands and move independently. Feasibility outcomes included recruitment/retention, adherence, participant satisfaction, safety, and adverse events. Results: Twenty-fve older adults (mean (standard deviation [SD]) age=77.55 (6.10) years, range 68–90 years) with early cognitive (Montreal Cognitive Assessment score (SD)=21.77 (4.05)) and mobility (92% were pre-frail/frail as indicated on the Fried Frailty Phenotype) impairments were recruited from a geriatric out-patient clinic or within the community. A total of 20/25 (80%) participants completed the study. Average class attendance was 72%, and self-reported homework adherence “most-days / every day” was 89%. A stepwise progression in the dance curricula was observed with increases in motor complexity and balance demands, and 95% of participants rated the program as a “just-right” challenge. Ninety percent of participants rated GERAS DANCE as excellent, and 100% would recommend the program to a friend or family member. Over 50% of participants connected outside of class time for a self-initiated cofee club. Adverse events of falls and fractures were reported for 2 participants, which occurred at home unrelated to the dance intervention during the study period. Pre-determined thresholds for feasibility were met for all outcomes. Discussion: GERAS DANCE is a feasible and enjoyable program for older adults with early cognitive or mobility impairments. GERAS DANCE curriculum grading (duration; sequence; instructions) and motor complexity increases in agility, balance, and coordination appear appropriately tailored for this population. Future work will explore the feasibility of GERAS DANCE in new settings (i.e., virtually online, community centers, or retirement homes) and the mind-body-social benefts of dance

Ensemble evaluation of hydrological model hypotheses

It is demonstrated for the first time how model parameter, structural and data uncertainties can be accounted for explicitly and simultaneously within the Generalized Likelihood Uncertainty Estimation (GLUE) methodology. As an example application, 72 variants of a single soil moisture accounting store are tested as simplified hypotheses of runoff generation at six experimental grassland field-scale lysimeters through model rejection and a novel diagnostic scheme. The fields, designed as replicates, exhibit different hydrological behaviors which yield different model performances. For fields with low initial discharge levels at the beginning of events, the conceptual stores considered reach their limit of applicability. Conversely, one of the fields yielding more discharge than the others, but having larger data gaps, allows for greater flexibility in the choice of model structures. As a model learning exercise, the study points to a “leaking” of the fields not evident from previous field experiments. It is discussed how understanding observational uncertainties and incorporating these into model diagnostics can help appreciate the scale of model structural error