Τετάρτη 4 Μαΐου 2022

Association of comorbidity score with perioperative outcomes following transoral robotic surgery: National analysis

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Abstract

Background

The association of comorbidities with perioperative outcomes after transoral robotic surgery (TORS) is not well-defined in the literature.

Methods

Using the National Cancer Database, 4004 patients with T1-T2 oropharyngeal cancer between 2010 and 2017 were stratified based on their Charlson–Deyo Comorbidity Class (CDCC). Thirty-day unplanned readmissions, 30-day mortality, and 90-day mortality were compared using chi-square test and logistic regression. Hospital length of stay (LOS) was compared using the Kruskal–Wallis test.

Results

LOS was greater for patients with CDCC 2 or 3 compared to CDCC 0 or 1 (p < 0.001). Increasing age and CDCC ≥3 were associated with 30-day mortality (CDCC ≥3: odds ratio [OR] 5.55, 95% confidence interval [CI] 1.59–19.45). CDCC ≥3 (OR 2.61, 95%CI 1.09–6.27) was significantly associated with 30-day readmissions.

Conclusion

This national analysis demonstrates greater rates of unplanned 30-day readmissions, longer hospitalizations, and increased 30- and 90-day mortality after TORS in patients with CDCC ≥3.

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Pharmacokinetics, safety and efficacy of intra‐articular non‐steroidal anti‐inflammatory drug injections for the treatment of osteoarthritis: A narrative review

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Pharmacokinetics, safety and efficacy of intra-articular non-steroidal anti-inflammatory drug injections for the treatment of osteoarthritis: A narrative review

We provide a comprehensive review on intra-articular (IA) non-steroidal anti-inflammatory drug (NSAID) injections for the treatment of osteoarthritis (OA). We found that single doses of IA NSAIDs provided far less total systemic and synovial exposure compared to a one week course of oral NSAIDs, but maximum concentrations to the synovium with IA administration were much higher. Further, single IA NSAID injections appeared to be safe and efficacious compared to courses of oral NSAIDs or single IA corticosteroids in either small animals, large animals or humans. Further research must be conducted, however, IA NSAIDs could be used as an alternative or adjunct therapy to treat OA related pain, especially for patients that are high risk for corticosteroid related adverse effects.


Abstract

What is known and Objective

Osteoarthritis (OA) is a common cause of joint disease and activity limitation in adults. Common therapies to treat OA-related pain are oral and topical non-steroidal anti-inflammatory drugs (NSAIDs) and intra-articular (IA) corticosteroids. However, prolonged courses of oral NSAIDs are associated with systemic adverse effects and repeat IA corticosteroid injections may cause cartilage degeneration. IA NSAIDs may be an alternative therapy possibly minimizing systemic side effects while maintaining efficacy. Therefore, we sought to summarize the pharmacokinetics, safety and efficacy of IA NSAIDs to help providers make a more informed decision on the use of IA NSAIDs.

Methods

We searched the National Library of Medicine Database with terms "intraarticular and nsaid", yielding 1032 results. Only traditional formulations of NSAIDs were considered for inclusion. Animal studies were included if animals were healthy or if the method of arthritis induction was a reasonable model of osteoarthritis. Human studies were included if humans were healthy or if the primary disease studied was osteoarthritis of a large joint. Of 1032 results, 31 research articles met the inclusion criteria and were summarized in this review.

Results and Discussion

We found that single doses of IA NSAIDs provided far less total systemic and synovial exposure compared to a one week course of oral NSAIDs, but maximum concentrations to the synovium with IA administration were much higher. IA NSAIDs had an excellent safety profile in small animals, large animals and humans, although these injections were associated with non-specific cartilage inflammation in healthy animals. In animal models, IA NSAIDs had similar efficacy to PO NSAIDs in treating OA-related pain. In humans, IA NSAIDs had similar efficacy to PO NSAIDS and IA corticosteroids in treating OA-related pain; however, many trials did not have a placebo control and outcome measures were heterogeneous.

What is new and Conclusion

Overall, single doses of IA NSAIDs appear safe and efficacious across animals and humans. The optimal use of IA NSAIDs is still to be determined and further research is needed. However IA NSAIDs may be an additional beneficial therapy to treat OA-related pain. Potential uses may be to augment IA corticosteroids injections, to interrupt multiple IA corticosteroid injections or as an alternative in patients that are high risk for corticosteroid-related adverse events.

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Lessons learned from proton vs photon radiation therapy for glioblastoma signal-finding trial

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We appreciate the astute comments of Drs Vogelius and Bentzen regarding the analyses reported in association with our phase II randomized trial of proton therapy (PT) vs intensity-modulated radiotherapy (IMRT) for patients with newly diagnosed glioblastoma (GBM).1 To address their question about the differences in the reported numbers, the abstract in 2017 reported the intention-to-treat (ITT) analysis of the available patients with completed follow-up whereas the final report presented updated ITT analyses as well as the important per-protocol analysis. The per-protocol analysis included a shift of 2 patients who were assigned to protons but received IMRT due to insurance denial for protons. This raises the learned challenges that were faced within this randomized trial comparing two radiation modalities that relied on insurance approvals eve n within the clinical trial context. We do summarize that although 90 patients consented, the analysis consisted of 67 patients because "the majority of patients were excluded before treatment began due to insurance denial of proton therapy" (p. 1340). There was a further loss of evaluable patients due to loss of follow-up, limiting the evaluable patients who completed neurocognitive function testing, our primary study endpoint. It is possible that further bias may have been introduced in the patients who chose to remain on study vs those who chose to no longer participate or were lost to follow-up. Due to these various competing factors that limited the evaluable patients as well as the primary goal of evaluating the cognitive effects of two treatments, we reported the per-protocol analysis in order to try and associate cognitive toxicity of the treatment received and its related brain dosimetry. When seeking to understand the differences particularly in treatment-related toxic ity between treatments in small phase II signal-finding trials, we argue that there is substantial value to ensuring you are comparing the clinical outcomes relative to delivered treatments, which requires an effective treatment analysis approach. Given the various lessons learned and challenges faced, we congratulate the forethought of the ongoing randomized proton trials that integrated more sophisticated randomization and trial designs to help address some of these challenges.
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