ABSTRACT
BACKGROUND: A 3-axis prioritization algorithm was proposed and was evaluated in a US multispecialist pilot study to obtain uniform consensus regarding effective practices for the use of intravenous immunoglobulin (IVIG) therapy. OBJECTIVE: The primary objective was to use consensus-building methodologies to rate disease states for IVIG utilization while considering disease severity and the efficacy of alternative therapeutic options to IVIG from the perspective of US multispecialists. METHODS: A 7-member multispecialty physician expert panel was surveyed to rate 50 disease states and to determine their level of agreement with the American Academy of Allergy, Asthma & Immunology (AAAAI) evidence-based medicine (EBM) ratings. The disease states were then rated across the 2 domains of disease severity and the perceived efficacy of therapeutic alternatives. An interquartile deviation (IQD) of ≤0.5 was used to determine consensus for disease states within each domain. Disease states reaching consensus across both domains were ranked according to a 2 × 4 algorithmic scale to establish priority for IVIG utilization. RESULTS: Overall, a high level of agreement was found with the AAAAI ratings for EBM. Based on an IQD of ≤0.5, the panel reached consensus on the severity of all 50 disease states. Of the 50 disease states, consensus was reached on the efficacy of therapeutic alternatives for 39 disease states. Using the same panel of experts, the 11 disease states without consensus in the first survey were resurveyed, and consensus was subsequently reached on 4 of them. Discussion among the experts, and the resurvey, resulted in expert consensus increasing from 78% to 86% postdiscussion and a change in the overall rating of IVIG on 4 conditions. CONCLUSIONS: Multispecialty input of 7 experts on evidence-based IVIG use, augmented with disease severity and efficacy of therapeutic alternatives, enables a balanced perspective on IVIG therapy prioritization. Moreover, multispecialty dialogue improved consensus building among panel members on the effective use of IVIG therapy in several clinical conditions.
ABSTRACT
PURPOSE: The development of skeletal-related events (SREs) (pathologic fracture, need for surgery and/or radiation to bone, spinal cord compression, and hypercalcemia of malignancy) in metastatic prostate cancer (MPC) is associated with worsened pain and compromised quality of life. Opioids are frequently used throughout the course of SRE treatment. This study describes the treatment patterns and incremental use of opioids in MPC patients diagnosed with SREs. METHODS: PC patients with bone metastases newly diagnosed with an SRE between January 1, 2005, and September 30, 2014, were identified using MarketScan Commercial and Medicare databases. Included patients were aged ≥40 years, had medical/pharmacy benefits for ≥12 months before (preindex) and ≥6 months after (postindex) diagnosis, and were without evidence of other primary cancers. Patients were categorized as nonusers of opioids (<10 days), short-term users (≥10 and <60 days), or long-term users (≥60 days) and further by SRE type. Opioid type, proportion of time on opioids, morphine-equivalent dose, adjuvant medications, and radiation use before and after SRE diagnosis were evaluated. FINDINGS: A total of 1071 eligible patients were identified (mean age, 71 years; 10.8% had chronic pain at baseline). The most common SRE types present were radiation (60.2%), radiation and bone surgery (15.0%), pathologic fracture (7.2%), and bone surgery (6.5%). Opioid use increased from 49.9% preindex to 53.3% postindex (P < 0.0001). The proportion of time on opioids doubled after SRE (pre, 0.3 vs post, 0.6; P < 0.0001). A greater percentage of patients used only opioids after an SRE (pre, 11.0%; post, 46.1% [P < 0.0001]), while a lesser percentage of patients used only radiation after an SRE (pre, 36.0%; post, 4.7% [P < 0.0001]). An increase was observed in patients using neither radiation nor opioids (pre, 14.5%; post, 42.0% [P < 0.0001]). An increase of ~50% was noted in long-term opioid users (from 22.1% to 32.1%). The use of monotherapy with a short-acting opioid decreased (pre, 35.1%; post, 32.5% [P < 0.0001]), while use of mixed opioids increased (pre, 13.7%; post, 19.1% [P < 0.0001]). Mean morphine-equivalent dose increased from pre- to post-SRE (9.1 vs 13.1 mg). Bisphosphonate and NSAID users decreased from before to after an SRE diagnosis (bisphosphonates, 40.2% vs 8.6%; NSAIDs, 26.7% vs 17.5% [both, P < 0.0001]). IMPLICATIONS: Long-term opioid use and dose were significantly increased after SRE development in MPC. The high percentage of patients not treated with an opioid or radiation potentially supports the need for additional treatment options for controlling pain if medically necessary and/or to prevent SREs.
