Out of the boxes,out of the silos: The need of interdisciplinary collaboration to reduce poor-quality medical products in the supply chain

In this paper, we argue that understanding and addressing the problem of poor-quality medical products requires a more interdisciplinary approach than has been evident to date. While prospective studies based on rigorous standardized methodologies are the gold standard for measuring the prevalence of poor-quality medical products and understanding their distribution nationally and internationally, they should be complemented by social science research to unpack the complex set of social, economic, and governance factors that underlie these patterns. In the following sections, we discuss specific examples of prospective quality surveys and of social science studies, highlighting the value of cross-sector partnerships in driving high-quality, policy-relevant research in this area.     

New evidence supporting lung cancer screening with low dose CT & surgical implications

IntroductionLung cancer is the leading cause of cancer-death worldwide. The U.S. Preventative Services Task Force (USPTSF) approved screening for current or former smokers aged 55–80 based on the results of the National Lung Screening trial (NLST). Following the NLST, new evidence has emerged from clinical trials and updates to previous trials prior to the anticipated update to the USPSTF guideline. We review the new evidence on lung cancer screening with low dose computed tomography (LDCT) and the surgical implications.MethodsA review of new literature was performed pertaining to lung cancer screening since implementation of UPSTF guidelines. Articles for inclusion were identified by both authors’, then search of the Pubmed and Cochrane database was performed from January 1st, 2013 through February 4th, 2020 using the MeSH search terms: “lung cancer”; “screening”; “low dose CT”. The results of these studies are summarized.ResultsWe identified multiple prospective randomized control trials and meta-analysis since the NLST supporting lung cancer-specific mortality with screening. We identified new nodule classification systems and the development of risk-models which may reduce false positive rates and identify high risk patients not currently eligible for screening. Finally, we discussed the surgical implications of screening.ConclusionNew data supports NLST findings and show ongoing benefit to LDCT for lung cancer screening. Standardized LDCT screening classification has been shown to reduce harm and lower false positive rates. Further study is needed regarding use of risk-modeling. Screening will require an increase in the thoracic workforce to accommodate the amount of surgically operable cancers.     

US Food and Drug Administration approvals for Bruton tyrosine kinase inhibitors in patients with chronic lymphocytic leukemia: Potential inefficiencies in trial design and evidence generation

The US Food and Drug Administration granted acalabrutinib approval as the second Bruton tyrosine kinase (BTK) inhibitor to treat patients with chronic lymphocytic leukemia and small lymphocytic lymphoma as monotherapy or in combination with obinutuzumab. This approval was based on 2 phase 3 trials: ELEVATE-TN and ASCEND. There are several concerns with the design of these trials, including suboptimal treatment of patients in the control arm, expansion of the trial population, and lack of data regarding efficacy or tolerability compared with ibrutinib, a first-in-class drug. The Food and Drug Administration approval of acalabrutinib for patients with chronic lymphocytic leukemia and small lymphocytic lymphoma represents concerning drug approval patterns in the United States and a weakness in evidence generation.     

The incidence of negative intraoperative findings after unsuccessful hydrostatic reduction of ileocolic intussusception in children: A retrospective analysis

Background

There is a lack of studies addressing the occurrence of negative intraoperative findings (that is the absence of intussusception) after an unsuccessful hydrostatic reduction of an ileocolic intussusception. The aim of this study is to determine the incidence of negative intraoperative findings after unsuccessful hydrostatic reduction of ileocolic intussusception.

Tears at the myotendinous junction of the infraspinatus: Ultrasound findings

PurposeTears involving the myotendinous junction (MTJ) of the infraspinatus (IS) have been recently described on MRI. These occur centrally in the muscle belly, and are not associated with full thickness tears of the distal infraspinatus tendon. They also induce a rapidly progressive fatty infiltration of the muscles and amyotrophy. The purpose of this study is to assess the accuracy of ultrasonography in diagnosing MTJ tears of the infraspinatus and to describe the usual ultrasonographic appearance compared with MRI.Materials and methodsRetrospective study of 2403 US examinations of the shoulder (over 5 years). Fifteen patients with a reported suspicion of infraspinatus MTJ tears were included. MRI examination was available in all cases, CT arthrography in 13 cases, and one patient underwent surgical confirmation.ResultsAll patients were sent for an ultrasound for suspect lesion of the tendons of the rotator cuff, with posterior pain in the infraspinatus fossa. All cases seen on ultrasonography were confirmed on MRI. CT arthrography confirmed the absence of tear of the IS tendon in all cases and did not reveal the MTJ tears. Two signs appeared to us as being of special interest: the “tadpole sign” on longitudinal views, and the “black eye sign” on sagittal views. The proximal retraction of the tendon at the MTJ is the anatomical explanation of both signs.ConclusionTears at the myotendinous junction of the infraspinatus are rare but can be diagnosed on US examination, provided that the sonographer pays attention to the infraspinatus fossa especially in cases of normality of the distal tendinous cuff.     

An eco-friendly HPLC-UV method for the determination of risedronate in its bulk and tablet dosage form with application to content uniformity,dissolution and stability testing

Risedronate is a nitrogen-containing bisphosphonate for the treatment and prevention of postmenopausal osteoporosis. The current work aims to develop a novel green HPLC-UV method for the rapid analysis of risedronate sodium in bulk and tablet formulation. The analyzed samples were separated on Waters Atlantis dC18 (150 mm × 3.9 mm; 5 μm) column using a green mobile phase consisting of potassium phosphate buffer pH 2.9 and potassium edetate buffer pH 9.5 in a ratio of 1:2, the final pH was adjusted to 6.8 with phosphoric acid, the mobile phase was pumped at a rate of 1.0 mL/min, with column temperature set at 30 °C, eluted samples were detected at 263 nm and the chromatographic run time was 3.0 min. The method was found to be linear over the concentration range of 14–140 μg/mL with a correlation coefficient (r²) of 0.9994. Accuracy and precision were evaluated from three QC samples (LQC, MQC and HQC) together with the five calibrators where the percentage accuracy was found to be 101.84%. Processed quality control samples of risedronate sodium were tested for stability at different conditions, short term, long term and freeze- thaw stability. The current method was further extended to study the content uniformity of Actonel® tablets following United States Pharmacopoeia (USP) guidelines. The proposed method was fully validated as per ICH guidelines.     

Update on sports imaging

Sports Imaging has dramatically increased in the past decade with increasing number of adolescents, young and middle-aged adults participating in non-competitive/hobby sports. Therefore, sports injuries are no longer confined to elite athletes. Furthermore, newer forms of sports such as mountain climbing, pickle ball and curling etc. are gaining popularity. Majority of the injuries in sports medicine are from musculoskeletal trauma. Therefore, it is imperative that the musculoskeletal radiologist becomes familiar with various sports related injury patterns as these are commonly encountered in daily practice. This update aims to briefly encapsulate the major aspects of sports imaging. It includes the imaging manifestations of various types of musculoskeletal injuries on different modalities (commonly US and MRI) and briefly mentions the various image guided interventions, performed both on the sports field and in the hospital setting.