The Multi-Attribute Method (MAM) Consortium was initially formed as a venue to harmonize best practices, share experiences, and generate innovative methodologies to facilitate widespread integration ...of the MAM platform, which is an emerging ultra-high-performance liquid chromatography–mass spectrometry application. Successful implementation of MAM as a purity-indicating assay requires new peak detection (NPD) of potential process- and/or product-related impurities. The NPD interlaboratory study described herein was carried out by the MAM Consortium to report on the industry-wide performance of NPD using predigested samples of the NISTmAb Reference Material 8671. Results from 28 participating laboratories show that the NPD parameters being utilized across the industry are representative of high-resolution MS performance capabilities. Certain elements of NPD, including common sources of variability in the number of new peaks detected, that are critical to the performance of the purity function of MAM were identified in this study and are reported here as a means to further refine the methodology and accelerate adoption into manufacturer-specific protein therapeutic product life cycles.
There is growing interest in providing palliative care (PC) in the emergency department (ED), but relatively little is known about the efficacy of ED-based PC interventions. A 2016 systematic review ...on this topic found no evidence that ED-based PC interventions affect patient outcomes or health care utilization, but new research has emerged since the publication of that review.
This systematic review provides a concise summary of current literature addressing the impact of ED-based PC interventions on patient-reported or family reported outcomes, health care utilization, and survival.
We searched PubMed, Embase, Web of Science, Scopus, and the Cumulative Index to Nursing and Allied Health Literature from inception until September 1, 2018 and reviewed references. Eligible articles evaluated the effects of PC interventions in the ED on patient-reported or family reported outcomes, health care utilization, or survival.
We screened 3091 abstracts and 98 full-text articles with 13 articles selected for final inclusion. Two articles reported the results of a single randomized controlled trial, whereas the remaining 11 studies were descriptive or quasi-experimental cohort studies. More than half of the included articles were published after the previous systematic review on this topic. Populations studied included older adults, patients with advanced malignancy, and ED patients screening positive for unmet PC needs. Most interventions involved referral to hospice or PC or PC provided directly in the ED. Compared with usual care, ED-PC interventions improved quality of life, although this improvement was not observed when comparing ED-PC to inpatient PC. ED-PC interventions expedited PC consultation; most studies reported a concomitant reduction in hospital length of stay and increase in hospice utilization, but some data were conflicting. Short-term mortality rates were high across all studies, but ED-PC interventions did not decrease survival time compared with usual care.
Existing data support that PC in the ED is feasible, may improve quality of life, and does not appear to affect survival.
Immune checkpoint inhibitors (ICIs) are increasingly used to treat a variety of cancers, but comparatively little is known about patient-reported outcomes (PROs) and health-related quality of life ...(HRQoL) among patients receiving these novel therapies.
We performed a systematic review to examine PROs and HRQoL among cancer patients receiving ICIs as compared to other anticancer therapies.
We systematically searched PubMed, CINAHL, Embase, Web of Science, and Scopus, using search terms representing ICIs, PROs, and HRQoL on August 10, 2018. Eligible articles were required to involve cancer patients treated with ICIs and to report PROs and/or HRQoL data.
We screened 1453 references and included 15 publications representing 15 randomized controlled trials in our analysis. Studies included several cancer types (melanoma, lung cancer, genitourinary cancer, and head/neck cancer), used four different ICIs (nivolumab, pembrolizumab, atezolizumab, and ipilimumab), and compared ICIs to a wide range of therapies (chemotherapy, targeted therapies, other immunotherapy strategies, and placebo). Studies used a total of seven different PROs to measure HRQOL, most commonly the European Organisation for the Research and Treatment of Cancer core quality of life questionnaire (EORTC QLQ-C30) (n = 12, 80%). PRO data were reported in a variety of formats and at a variety of time points throughout treatment, which made direct comparison challenging. Some trials (n = 11, 73%) reported PROs on specific symptoms. In general, patients receiving ICIs had similar-to-improved HRQoL and experiences when compared to other therapies.
Despite the broad clinical trials experience of ICI therapies across cancer types, relatively few randomized studies reported PROs and patient HRQoL data. Available data suggest that ICIs are well tolerated in terms of HRQoL compared to other anticancer therapies although the conclusions are limited by the heterogeneity of trial designs and outcomes. Currently used instruments may fail to capture important symptomatology unique to ICIs, underscoring a need for PROs designed specifically for ICIs.
We investigate the effect of initial provider (psychiatrist versus primary care physician or non-physician mental health specialist) on the adequacy of subsequent treatment for persons with ...depression. Our data are from MarketScan
®, a medical and pharmacy insurance claims database, which we use to estimate models of the likelihood of treatment for depression and the likelihood that any anti-depression treatments received are adequate. Patients initially seeing psychiatrists are most likely to receive adequate treatment. Provider type has a statistically and medically significant effect on whether any treatment occurs but a smaller effect on treatment adequacy among treated patients. Our results show the importance of provider type in treatment patterns, but the effects on patient outcomes are yet to be determined definitively.
Although the literature on transitions from hospital to the community is extensive, little is known about this experience within the context of palliative care (PC).
We conducted a systematic review ...to investigate the impact of receiving palliative care in hospital on the transition from hospital to the community.
We systematically searched MEDLINE, Embase, ProQuest, and CINAHL from 1995 until April 10, 2018, and extracted relevant references. Eligible articles were published in English, included adult patients receiving PC as inpatients, and explored transitions from hospital to the community.
A total of 1514 studies were identified and eight met inclusion criteria. Studies were published recently (>2012; n = 7, 88%). Specialist PC interventions were delivered by multidisciplinary care teams as part of inpatient PC triggers, discharge planning programs, and transitional care programs. Common outcomes reported with significant findings consisted of length of stay (n = 5), discharge support (n = 5), and hospital readmissions (n = 6) for those who received inpatient PC. Most studies were at high risk of bias.
Heterogeneity of study designs, outcomes, findings, and poor methodological quality renders it challenging to draw conclusions regarding PC's impact on the transition from hospital to home. Further research should use standardized outcomes with randomized controlled trial and/or propensity matched cohort designs.
The multi-attribute method (MAM) was conceived as a single assay to potentially replace multiple single-attribute assays that have long been used in process development and quality control (QC) for ...protein therapeutics. MAM is rooted in traditional peptide mapping methods; it leverages mass spectrometry (MS) detection for confident identification and quantitation of many types of protein attributes that may be targeted for monitoring. While MAM has been widely explored across the industry, it has yet to gain a strong foothold within QC laboratories as a replacement method for established orthogonal platforms. Members of the MAM consortium recently undertook an interlaboratory study to evaluate the industry-wide status of MAM. Here we present the results of this study as they pertain to the targeted attribute analytics component of MAM, including investigation into the sources of variability between laboratories and comparison of MAM data to orthogonal methods. These results are made available with an eye toward aiding the community in further optimizing the method to enable its more frequent use in the QC environment.
After the implementation of a laparoscopic skills curriculum, we studied two questions: (1) can skills curriculum participation improve performance and (2) can we identify housestaff who may benefit ...from early instruction in laparoscopic technical skills?
We administered a six-task laparoscopic skills curriculum to postgraduate year (PGY) 2 and PGY3 surgical housestaff. Six laparoscopic tasks were divided into two groups: generalized skills and task specific skills. All participants were evaluated during a pretest and were placed in the novice group (total score less than 600) or in the intermediate skill (IS) group (total score 600 or more). Each participant had two 1-hour practice/instruction sessions and 2 weeks for independent practice. After these sessions, a posttest was administered.
Novices and intermediate skill participants demonstrated significant improvement in general skills and task specific skills. However, comparison of novice and IS group learners revealed that IS group learners were significantly more proficient in the performance of general skills, but the performance of task specific skills failed to demonstrate a difference between the two groups. On posttest, there was no significant difference in overall score between novices and IS participants.
Overall ability and performance of generalized skills by all housestaff are improved with a laparoscopic skills curriculum; however, the performance of novices improved the greatest. Task specific skills did not discriminate novices from more advanced learners. Early testing of housestaff may identify those individuals who could benefit from intervention and instruction prior to performing the laparoscopic skills in the operating room.
Patients with significant burn injuries likely have palliative care needs.
We performed a systematic review of existing evidence concerning the palliative care needs of burn patients.
Through ...November 26, 2018, we systematically searched PubMed, CINAHL, Embase, Web of Science, and Scopus, using terms representing burn injuries and the eight domains of quality palliative care as outlined by the National Consensus Project for Quality Palliative Care. Eligible articles involved burn-injured patients treated with an intervention targeting at least one of the eight domains.
Our searches yielded 7532 unique records, which led to 238 articles for full review and 88 studies that met inclusion criteria. Seventy-five studies addressed the domain physical aspects of care and merit a separate systematic review; 13 studies were included in our final review. Four of the seven domains—processes of care, psychologic symptoms, social aspects, and end of life—were addressed by studies but three domains—spiritual, cultural, or ethics—were unaddressed. Included studies highlight potential benefits from peridischarge self-care education programs, peer support, and group therapy in improving quality of life. In patients with severe injuries, end-of-life decision-making protocols were associated with increased utilization of comfort-focused treatments.
Most existing palliative care-related research in burn patients addresses interventions for physical symptoms with minimal literature concerning other domains. Opportunities exist for further research of palliative care in burn populations with emphasis on addressing interventions for all domains and better standardizing the language and outcomes for the palliative care interventions.
PDF
