Primary care physician time utilization before and after implementation of an electronic health record: a time-motion study

Despite benefits associated with the use of electronic health records (EHRs), one major barrier to adoption is the concern that EHRs may take longer for physicians to use than paper-based systems. To address this issue, we performed a time-motion study in five primary care clinics. Twenty physicians were observed and specific activities were timed during a clinic session before and after EHR implementation. Surveys evaluated physicians' perceptions regarding the EHR. Post-implementation, the adjusted mean overall time spent per patient during clinic sessions decreased by 0.5 min (p=0.86; 95% confidence interval [-5.05, 6.04]) from a pre-intervention adjusted average of 27.55 min (SE=2.1) to a post-intervention adjusted average of 27.05 min (SE=1.6). A majority of survey respondents believed EHR use results in quality improvement, yet only 29% reported that EHR documentation takes the same amount of time or less compared to the paper-based system. While the EHR did not require more time for physicians during a clinic session, further studies should assess the EHR's potential impact on non-clinic time.     

A comparison between fibrin sealant and sutures for attaching conjunctival autograft after pterygium excision

Background

Use of conjunctival autograft following excision of primary pterygium has reduced the recurrence rate. This study evaluates the efficiency of fibrin glue as compared to sutures in attaching the conjunctival autograft with reference to surgical time, post operative comfort and recurrence during follow up.

Methods

60 patients with primary pterygium were included and divided into two groups. In the first group autograft was secured in place with help of 10-0 polyamide monofilament suture while in second group fibrin glue was used. Both the groups were compared in terms of operative time, post op comfort and recurrence.

Results

The average surgical time taken was 50.93 ± 4.96 min with suture group and 34.43 ± 4.94 min with fibrin glue group. Pain and foreign body sensation was markedly less with fibrin glue group. At the end of final follow up at 6 months, 3 cases (10%) from suture group and 1 case (3.33%) from fibrin group had recurrence.

Conclusion

Fibrin glue is effective and safe for attaching conjunctival autograft during pterygium surgery. Although more number of recurrences were observed in suture group as compared to fibrin glue group the difference was not statistically significant (p 0.612).     

Development of a Human Antibody Tolerant Mouse Model to Assess the Immunogenicity Risk Due to Aggregated Biotherapeutics

We describe a novel human immunoglobulin G₂ (IgG₂)-tolerant and immune-competent heterozygous mouse model (Xeno-het) developed by crossbreeding a human Ig-tolerized XenoMouse® with a C57BL/6J wild-type mouse. The Xeno-het mouse expresses both mouse and human immunoglobulin G (IgG) genes, resulting in B-cells expressing human and mouse IgG, and secretion of human and mouse Ig into serum. This model was utilized to evaluate the immunogenicity risk of aggregated and chemically modified human antibodies. The mice were tested for their ability to break tolerance to self-tolerant monomeric antibodies. Aggregates made by mechanical stirring elicited an anti-drug antibody (ADA) response, but did not induce a robust and long-term memory B and T-cell response. Chemically modified antibodies made by oxidation were only weak and transient inducers of an immune response, as measured by a lack of both an ADA response and a B-cell antigen-specific response. Aggregate size was an important characteristic, as specific-sized protein-coated beads were able to elicit an immune response. We propose the use of this model to identify risk factors such as aggregation during manufacturing at early development for an increased potential immunogenicity risk. © 2013 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 102:3545–3555, 2013     

Healthcare resource utilization in patients with metastatic melanoma receiving first-line therapy with dabrafenib + trametinib versus nivolumab or pembrolizumab monotherapy

Objective: To compare healthcare resource utilization (HRU) between patients with metastatic melanoma (MM) initiated on first-line (1L) combination therapy with the BRAF inhibitor dabrafenib and the MEK inhibitor trametinib (D?+?T; oral) and those initiated on 1?L monotherapy with the anti-PD1 monoclonal antibodies nivolumab or pembrolizumab (N/P; intravenous).

Methods: Patients with melanoma initiated on D?+?T or N/P from Q1/2014 to Q2/2016 (defined as 1?L treatment for MM) were identified in the Truven MarketScan database. Entropy balancing was used to reweight the N/P cohort in order to make it comparable to the D?+?T cohort with respect to the mean and variance of baseline covariates. HRU outcomes during 1?L therapy, reported per patient-year (PPY), were described and compared between the two cohorts post-weighting (i.e. independently of baseline covariates).

Results: Of the 445 patients included, 202 and 243 were initiated on D?+?T and N/P, respectively. After weighting, patients initiated on N/P had more outpatient visits for drug administration during 1?L therapy than those initiated on D?+?T (difference?=?18.6 visits PPY [95% CI?=?16.0–21.1]). Patients initiated on N/P also had more outpatient office visits for reasons other than drug administration (difference?=?8.1 visits PPY [95% CI?=?1.9–13.7]). No significant differences were observed for other HRU parameters (i.e. inpatient admissions, inpatient days, and emergency department visits during 1?L therapy).

Conclusions: HRU during 1?L therapy was generally similar between patients initiated on D?+?T and N/P. Nonetheless, patients initiated on N/P had more outpatient visits, including more outpatient visits for reasons unrelated to drug administration.     

Development and Validation of an RP-HPLC Method for Quantitative Estimation of Eslicarbazepine Acetate in Bulk Drug and Tablets

A convenient, simple, accurate, precise and reproducible RP-HPLC method was developed and validated for the estimation of eslicarbazepine acetate in bulk drug and tablet dosage form. Objective was achieved under optimised chromatographic conditions on Dionex RP-HPLC system with Dionex C18 column (250×4.6 mm, 5 μm particle size) using mobile phase composed of methanol and ammonium acetate (0.005 M) in the ratio of 70:30 v/v. The separation was achieved using an isocratic elution method with a flow rate of 1.0 ml/ min at room temperature. The effluent was monitored at 230 nm using diode array detector. The retention time of eslicarbazepine acetate is found to be 4.9 min and the standard calibration plot was linear over a concentration range of 10-90 μg/ml with r²=0.9995. The limit of detection and quantification were found to be 3.144 and 9.52 μg/ml, respectively. The amount of eslicarbazepine acetate in bulk and tablet dosage form was found to be 99.19 and 97.88%, respectively. The method was validated statistically using the percent relative standard deviation and the values are found to be within the limits. The recovery studies were performed and the percentage recoveries were found to be 98.33± 0.5%.     

Drug Treatment of Acute Ischemic Stroke

Acute ischemic stroke (AIS) is the fourth leading cause of death and the leading cause of adult disability in the USA. AIS most commonly occurs when a blood vessel is obstructed leading to irreversible brain injury and subsequent focal neurologic deficits. Drug treatment of AIS involves intravenous thrombolysis with alteplase (recombinant tissue plasminogen activator [rtPA]). Intravenous alteplase promotes thrombolysis by hydrolyzing plasminogen to form the proteolytic enzyme plasmin. Plasmin targets the blood clot with limited systemic thrombolytic effects. Alteplase must be administered within a short time window to appropriate patients to optimize its therapeutic efficacy. Recent trials have shown this time window may be extended from 3 to 4.5 hours in select patients. Other acute supportive interventions for AIS include maintaining normoglycemia, euthermia and treating severe hypertension. Urgent anticoagulation for AIS has generally not shown benefits that exceed the hemorrhage risks in the acute setting. Urgent antiplatelet use for AIS has limited benefits and should only promptly be initiated if alteplase was not administered, or after 24 hours if alteplase was administered. The majority of AIS patients do not receive thrombolytic therapy due to late arrival to emergency departments and currently there is a paucity of acute interventions for them. Ongoing clinical trials may lead to further medical breakthroughs to limit the damage inflicted by this devastating disease.     

Medical factors affecting patency of arteriovenous access

Arteriovenous access failure is multifactorial in nature with contributions from both medical and surgical etiologies. Medical causes of arteriovenous access failure are rare, and therefore infrequently identified as a major contributing source of malfunction. Although they account for only 10-15% of all cases of access failure, their importance should not be underestimated, especially in cases where a surgical source cannot be identified. Most medical causes are derived from Virchow's triad of endothelial cell injury, stasis, and hypercoaguability. Endothelial cell injury occurs through oxidative stress, activated platelets, increased levels of circulating tumor necrosis factor-alpha, and preexisting intimal hyperplasia. Stasis can occur through prolonged access compression, hypotension, or hypoalbuminemia. Finally, patients with renal failure requiring hemodialysis are frequently at increased risk for hypercoaguable states, except for situations of platelet dysfunction, and therefore access failure. Potential treatments include identifying and removing the offending source, as well as innovative, new medications to prevent their reoccurrence. Treatment is aimed at improving quality of life, as well as decreasing morbidity and hospital admissions in this difficult patient population.     

Confirmation of location of epidural catheters by epidural pressure waveform and computed tomography cathetergram

OBJECTIVE: Epidural pressure has remained a relatively unused test of physiological monitoring for the past 3 decades. It is our hypothesis that epidural pressure waveforms (EPWFs) obtained by transducing an epidural catheter (EC) can be used as a surrogate for the accurate location of the EC. The goal of this study was to validate this new method by comparing it with a more objective radiographic technique such as computed tomography cathetergram (CTC). METHODS: The EPWF and CTC were studied in 13 patients receiving continuous epidural analgesia (12 patients who had postoperative pain and 1 patient who had chronic pain). Of these 13 patients, 8 patients had reported inadequate analgesia, and 5 had reported satisfactory analgesia. First, the end of the EC was connected to a disposable pressure transducer, this was followed by a 5-mL normal saline bolus injection to ensure the patency of the EC, and the EPWF was recorded. Next, the patient was taken to an imaging suite and, after injecting contrast through the EC, the course of the catheter was imaged with computed tomography (CT). The CT images were studied by the neuroradiologist and correlated with the EPWF. RESULTS: The EPWF of 5 patients with clinically adequate analgesia revealed a pulsatile waveform on transducing the EC and a crescentic spread of contrast in the epidural space on CTC. In 8 patients with inadequate epidural analgesia, the EPWF measurement failed to show oscillations, and contrast collections were observed in the paraspinous muscles. The results of EPWF and CTC were compared using Fisher's exact test. CONCLUSIONS: The strong relationship between EPWF and CTC suggests that EPWF can be used reliably to confirm the correct placement of the EC in a selected group of patients.     

Preoperative blood volume deficit influences blood transfusion requirements in females and males undergoing coronary bypass graft surgery

STUDY OBJECTIVE: To evaluate whether preoperative blood volume and postoperative blood loss influence blood transfusion in females and males undergoing coronary artery bypass graft (CABG) surgery. DESIGN: Prospective study. SETTING: Anesthesiology department of a teaching hospital. PATIENTS: 57 CABG patients (21 females and 36 males). MEASUREMENTS: Blood volume was determined using the radioactivity dilution method. Preoperatively, each patient received intravenous (IV) injection of 1 mL Albumin I(131) tracer having 25 microcuries of radioactivity. Five-milliliter blood samples were collected at different intervals. From these samples, hematocrit (Hct) value, preoperative total blood volume, red blood cell (RBC) volume, and plasma volume were determined. Postoperatively, some consenting patients received another 1 mL dose of the tracer, and the postoperative blood volumes were determined. If a patient received a blood transfusion, the units of packed red blood cells (PRBCs), platelets, or fresh frozen plasma (FFP) transfused were recorded. For each patient we recorded the gender, age, weight, height, body surface area (BSA), preoperative Hct, duration of surgery, and discharge Hct. RESULTS: Preoperatively, the mean total blood volume, RBC volume, and plasma volume, respectively, were 2095 mL/m(2), 631 mL/m(2), and 1,465 mL/m(2) in females; and 2,580 mL/m(2), 878 mL/m(2), and 1,702 mL/m(2) in males. The preoperative blood volumes were significantly lower (p < 0.01) in females than in males. There was no significant difference between males and females in the extent of blood loss during CABG. Intraoperatively, females received PRBC transfusion of 1.38 units, significantly more (p < 0.01) than the 0.39 units received by males. During the entire hospital stay, females received 4.33 units of PRBC, significantly more than (p < 0.02) the 1.33 units received by males. Significantly more (p < 0.01) females (12 of 21) received intraoperative PRBC transfusion than did males (6 of 36). Multiple logistic regression analysis of the data showed that PRBC transfusion was significantly correlated with the preoperative total blood volume and RBC volume. CONCLUSION: The greater need for blood transfusion in females than in males during CABG is primarily attributable to significantly lower preoperative total blood volume and RBC volume in females.