The choice of a bioprosthetic valve (BV) or mechanical valve (MV) in middle-aged adults undergoing aortic valve replacement is a complex decision that must account for numerous prosthesis and patient factors. A systematic review and meta-analysis was performed to compare long-term survival, major adverse prosthesis-related events, anticoagulant-related events, major bleeding, reoperation, and structural valve degeneration in middle-aged patients receiving a BV or MV. A comprehensive search from six electronic databases was performed from their inception to February 2016. Results from patients aged less than 70 years undergoing aortic valve replacement with a BV or MV were included. There were 12 studies involving 8,661 patients. Baseline characteristics were similar. There was no significant difference in long-term survival among patients aged 50 to 70 or 60 to 70 years. Compared with MVs, BVs had significantly fewer long-term anticoagulant-related events (hazard ratio [HR] 0.54, p = 0.006) and bleeding (HR 0.48, p < 0.00001) but significantly greater major adverse prosthesis-related events (HR 1.82, p = 0.02), including reoperation (HR 2.19, p < 0.00001). The present meta-analysis found no significant difference in survival between BVs and MVs in patients aged 50 to 70 or 60 to 70 years. Compared with MVs, BVs have reduced risk of major bleeding and anticoagulant-related events but increased risk of structural valve degeneration and reoperation. However, the mortality consequences of reoperation appear lower than that of major bleeding, and recent advances may further lower the reoperation rate for BV. Therefore, this review supports the current trend of using BVs in patients more than 60 years of age.

The rapid development of immuno-oncology (I-O) therapies for multiple types of cancer has transformed the cancer treatment landscape and brightened the long-term outlook for many patients with advanced cancer. Responding to ongoing efforts to generate value assessments for novel therapies, multiple stakeholders have been considering the question of “What makes I-O transformative?” Evaluating the distinct features and attributes of these therapies, and better characterizing how patients experience them, will inform such assessments. This paper defines ways in which treatment with I-O is different from other therapies. It also proposes key aspects and attributes of I-O therapies that should be considered in any assessment of their value and seeks to address evidence gaps in existing value frameworks given the unique properties of patient outcomes with I-O therapy. The paper concludes with a “data needs catalogue” (DNC) predicated on the belief that multiple key, unique elements that are necessary to fully characterize the value of I-O therapies are not routinely or robustly measured in current clinical practice or reimbursement databases and are infrequently captured in existing research studies. A better characterization of the benefit of I-O treatment will allow a more thorough assessment of its benefits and provide a template for the design and prioritization of future clinical trials and a roadmap for healthcare insurers to optimize coverage for patients with cancers eligible for I-O therapy.

Decision-makers have become increasingly interested in incorporating real-world evidence (RWE) into their decision-making process. Due to concerns regarding the reliability and quality of RWE, stakeholders have issued numerous recommendation documents to assist in setting RWE standards. The fragmented nature of these documents poses a challenge to researchers and decision-makers looking for guidance on what is ‘high-quality’ RWE and how it can be used in decision-making. We offer researchers and decision-makers a structure to organize the landscape of RWE recommendations and identify consensus and gaps in the current recommendations. To provide researchers with a much needed pathway for generating RWE, we discuss how decision-makers can move from fragmented recommendations to comprehensive guidance.

Our findings demonstrated that TAPP repair did not have higher rate of morbidity or hernia recurrence and is an equivalent approach to open repair, with the advantages of faster recovery and reduced paraesthesia.

Approximately 10.3% of US children aged 6-18 years (population estimate 5.5 million) have 25(OH)D levels <16 ng/mL.