COPD in a Nationally Representative Sample: Sociodemographic Factors and Co-morbidity,Diagnosis Method,and Healthcare Utilization

Introduction: In 2011, the Centers for Disease Control and Prevention for the first time ever collected nationally representative prevalence data on chronic obstructive pulmonary disease (COPD), spirometry diagnosis, and healthcare utilization factors related to COPD. This research reports on that data and describes characteristics of adults with COPD who reported diagnosis by spirometry compared to those who did not report diagnosis by spirometry. Variables examined included basic elements of healthcare utilization such as emergency room visits, hospitalization or personal physician utilization. Methods: This is a cross-sectional study using novel data from the 2011 Behavioral Risk Factor Surveillance System COPD Module. Weighted multivariable logistic regression examined factors associated with (n = 13,484) and without spirometry (n = 3,131). Results: Spirometry to diagnose COPD was reported by 78% of adults and increased with age. In multivariable modeling, spirometry was more likely in: Black, non-Hispanic compared to white non-Hispanic; current and former compared to never smokers; adults with co-morbidity including asthma, depression, and cardiovascular disease; adults with a doctor; and those who had been to emergency room/hospital for COPD. Those less likely to receive a spirometry were: Hispanic and reported exercise in the past 30 days. Conclusions: This study identified that adults diagnosed with COPD without a spirometry tended to be Hispanic, younger, healthier, and had less utilization of medical resources. This study is a first step in understanding the potential impact of COPD diagnosis made without spirometry.     

Three-dimensional aspects of formulation excipients in drug discovery: a critical assessment on orphan excipients,matrix effects and drug interactions

Formulation/pharmaceutical excipients play a major role in formulating drug candidates, with the objectives of ease of administration, targeted delivery and complete availability. Many excipients used in pharmaceutical formulations are orphanized in preclinical drug discovery. These orphan excipients could enhance formulatability of highly lipophilic compounds. Additionally, they are safe in preclinical species when used below the LD₅₀ values. However, when the excipients are used in formulating compounds with diverse physico-chemical properties, they pose challenges by modulating study results through their bioanalytical matrix effects. Excipients invariably present in study samples and not in the calibration curve standards cause over-/under- estimation of exposures. Thus, the mechanism by which excipients cause matrix effects and strategies to nullify these effects needs to be revisited. Furthermore, formulation excipients cause drug interactions by moderating the pathways of drug metabolizing enzymes and drug transport proteins. Although it is not possible to get rid of excipient driven interactions, it is always advised to be aware of these interactions and apply the knowledge to draw meaningful conclusions from study results. In this review, we will comprehensively discuss a) orphan excipients that have wider applications in preclinical formulations, b) bioanalytical matrix effects and possible approaches to mitigating these effects, and c) excipient driven drug interactions and strategies to alleviate the impacts of drug interactions.     

Effect of Diabetes on Transscleral Delivery of Celecoxib

Purpose  To investigate the effects of diabetes on transscleral retinal delivery of celecoxib in albino and pigmented rats. Methods  Albino (Sprague Dawley—SD) and pigmented (Brown Norway—BN) rats were made diabetic by a single intraperitoneal injection of streptozotocin (60 mg/kg) following 24 h of fasting and diabetes was confirmed (blood glucose >250 mg/dL). Two months after diabetes induction, the integrity of blood-retinal-barrier in control versus diabetic rats from both strains was compared by using FITC-dextran leakage assay. Fifty microliter suspension of celecoxib (3 mg/rat) was injected periocularly in both the strains in one eye, 2 months following diabetes induction. The animals were euthanized at the end of 0.25, 0.5, 1, 2, 3, 4, 8, and 12 h post-dosing and celecoxib levels in ocular tissues and plasma were estimated using a HPLC assay. Results  Diabetes (2-month duration) resulted in 2.4 and 3.5 fold higher blood-retinal barrier leakage in diabetic SD and BN rats, respectively, compared to controls. The area under tissue celecoxib concentration versus time curves (AUC) for sclera, cornea, and lens were not significantly different between control and diabetic animals. However, retinal and vitreal AUCs of celecoxib in treated eyes were approximately 1.5-fold and 2-fold higher in diabetic SD and BN rats, respectively, as compared to the controls. Conclusions  Transscleral retinal and vitreal delivery of celecoxib is significantly higher in diabetic animals of both strains. The increase in retinal delivery of celecoxib due to diabetes is higher in pigmented rats compared to albino rats. Higher delivery of celecoxib in diabetic animals compared to control animals can be attributed to the disruption of blood-retinal barrier due to diabetes.     

Validation of a novel postoperative quality-of-life scoring system

Background

No specific scoring system exists for the assessment of postoperative quality of life (QOL) after major abdominal surgery. This study prospectively validates PQL, a novel prospective scoring system in patients having laparoscopic or open major abdominal colorectal surgery.

Methods

Six experienced surgeons developed the questionnaire. Twenty patients reviewed and selected the most relevant questions, yielding 14 questions. One hundred patients undergoing a variety of colorectal procedures completed the questionnaire preoperatively, and on postoperative days (POD) 1, 2, 4, 8, 12, 30, and 60. Internal validation was assessed by Cronbach's alpha and factor analysis.

Results

Cronbach's alpha revealed excellent internal consistency, ranging from .84 to .94 at all time points, even at POD 1 when Cronbach's alpha was .79, demonstrating that the items in the questionnaire measured the same underlying construct. Factor analysis consistently loaded at each follow-up time on the same 2 factors.

Conclusions

Factor analysis consistently loaded at each follow-up time on the same 2 factors, designated the PQL Symptom Score and the PQL Recover Score.     

Evaluation of the role of laparoscopic ultrasonography in the staging of oesophagogastric cancers

Introduction  The role of laparoscopic ultrasound (LUS) during staging laparoscopy for pancreatic cancers is established but remains debatable in evaluating oesophagogastric cancers. Methods  A retrospective consecutive case series consisting of patients undergoing staging laparoscopy in two centres (centre A and B) was carried out over a 5-year period (2000–2005). Patients in centre B underwent LUS following laparoscopic assessment using a 7.5-MHz probe. Staging laparoscopy in both centres was performed using a standardised three-port protocol using a 30° laparoscope. All suspicious lesions were sent for histological assessment for confirmation of malignancy. Results  There were 201 patients in centre A (83 gastric, 138 lower oesophageal/junctional cancers) and 119 patients in centre B (51 and 68, respectively). There were no differences between the two centres for patient demographics and tumour site. There was no difference between the two centres for the detection of metastatic disease using laparoscopic assessment alone (A 13% versus B 20%, p = 0.12). However, there was a significant difference (13% versus 28%, p = 0.001) with the additional use of LUS in centre B. The findings in the additional 8% (n = 9) were para-aortic lymphadenopathy (n = 5), liver metastasis (n = 3) and local extension (n = 1). Five had gastric and four lower oesophageal/junctional cancers. The negative predictive value was 6.4% for centre A and 4.5% for centre B. Conclusion  The addition of LUS increased the detection rate of metastasis by 8% but there was little impact on the false-negative rate. LUS is useful in detecting metastatic lymphadenopathy beyond the limits of curative resection and liver metastasis.