Researcher Experience and Comfort With Telemedicine and Remote Patient Monitoring in Cancer Treatment Trials.

BACKGROUND: Since the onset of COVID-19, oncology practices across the US have integrated telemedicine (TM) and remote patient monitoring (RPM) into routine care and clinical trials. The extent of provider experience and comfort with TM/RPM in treatment trials, however, is unknown. We surveyed oncology researchers to assess experience and comfort with TM/RPM. METHODS: Between April 10 and June 1, 2022, we distributed email surveys to US-based members of the American Society of Clinical Oncology (ASCO) whose member records indicated interest or specialization in clinical research. We collected respondent demographic data, clinical trial experience, workplace characteristics, and comfort and experience with TM/RPM use across trial components in phase I and phase II/III trials. TM/RPM was defined as clinical trial-related healthcare and monitoring for patients geographically separated from trial site. RESULTS: There were 141 surveys analyzed (5.1% response rate). Ninety percent of respondents had been Principal Investigators, 98% practiced in a norural site. Most respondents had enrolled patients in phase I (82%) and phase II/III trials (99%). Across all phases and trial components, there was a higher frequency of researcher comfort compared to experience. Regarding remote care in treatment trials, 75% reported using TM, RPM, or both. Among these individuals, 62% had never provided remote care to trial patients before the pandemic. CONCLUSION: COVID-19 spurred the rise of TM/RPM in cancer treatment trials, and some TM/RPM use continues in this context. Among oncology researchers, higher levels of comfort compared with real-world experience with TM/RPM reveal opportunities for expanding TM/RPM policies and guidelines in oncology research.

Association Between Copayment Assistance, Insurance Type, Prior Authorization, and Time to Receipt of Oral Anticancer Drugs.

PURPOSE: Oral anticancer drugs (OACDs) have become increasingly prevalent over the past decade. OACD prescriptions require coordination between payers and providers, which can delay drug receipt. We examined the association between insurance type, pursuit of copayment assistance, pursuit of prior authorization (PA), and time to receipt (TTR) for new OACD prescriptions. METHODS: We prospectively collected data on new OACD prescriptions for adult oncology patients from January 1, 2018, to December 31, 2019, including demographic and clinical characteristics, insurance type, and pursuit of PA and copayment assistance. TTR was defined as the number of days from prescription to OACD receipt. We summarized TTR using cumulative incidence and compared TTR by insurance type, pursuit of copayment assistance, and PA activity using the log-rank test. RESULTS: Our cohort of 1,024 patients was 53% male, and 40% were younger than 65. Twenty-six percent had commercial insurance only, 16% had Medicaid only, and 59% had Medicare with or without additional insurance. Eighty-six percent of prescriptions were successfully received. Across all prescriptions, 69% involved PA activity, and 21% involved the copayment assistance process. In unadjusted analyses, prescriptions involving the copayment assistance process had longer TTR compared with those not involving assistance (log-rank P value = .005) and OACDs covered by Medicare/commercial insurance had a longer TTR compared with Medicaid (log-rank P value = .006). The PA process was not associated with TTR (log-rank P value = .124). CONCLUSION: The process for obtaining OACDs is complex. The copayment assistance process and Medicare/commercial insurance are associated with delayed TTR. New policies are needed to reduce time to OACD receipt.

Impact of a Hospital-Based Specialty Pharmacy in Partnership With a Care Coordination Organization on Time to Delivery and Receipt of Oral Anticancer Drugs.

PURPOSE: Oral anticancer drug (OACD) prescriptions require extensive coordination between providers and payers, which can delay drug receipt. Specialty pharmacies facilitate communication between multiple entities. In 2018, our cancer center partnered with a freestanding organization to implement a hospital-based specialty pharmacy (HB-SP). We evaluated the time to drug receipt (TTR) before and after HB-SP implementation. METHODS: Data were prospectively collected on all new OACD prescriptions for adult oncology patients from January 1, 2018, to December 31, 2019. In fall 2018, a HB-SP was initiated. We collected patient sociodemographic, clinical, and prescription data. TTR was the number of days from OACD prescription to drug receipt. We used multivariable logistic regression to examine factors associated with TTR ≤ 7 days before and after HB-SP implementation. RESULTS: In total, 954 patients were included, representing 1,102 new OACDs. The majority of prescribed drugs were targeted OACDs (56%, n = 617), and 71% (n = 779) required prior authorization. Of all prescriptions, 84% (n = 960) were successfully received with an overall median TTR of 7 days. In unadjusted analysis, HB-SP implementation, drug class, race and ethnicity, and prior authorization requirement were significantly associated with TTR. Adjusted analyses found that patients were more likely to receive their drugs ≤ 7 days after HB-SP implementation (53% v 47%; adjusted odds ratio [aOR], 1.29; 95% CI, 1.00 to 1.68; P = .05). CONCLUSION: The implementation of a HB-SP in partnership with a collaborative care model contributed to a decrease in TTR for OACDs. This difference is in part attributable to improved care coordination and communication. A centralized approach may improve overall efficiency due to fewer practice disruptions.

Factors Associated With Patients Not Receiving Oral Anticancer Drugs.

Importance: Oral anticancer drugs (OACDs) are increasingly prescribed for cancer treatment and require significant coordination of care. Retrospective studies suggest that 10% to 20% of OACD prescriptions are never received by the patients, but the reasons behind this are poorly understood. Objectives: To estimate the rate of failure to receive OACD prescriptions among patients with cancer and to examine the underlying reasons for this failure. Design, Setting, and Participants: A prospective cohort study was conducted among patients with cancer who were prescribed a new OACD from January 1, 2018, to December 31, 2019, at an urban academic medical center. Data analysis was conducted between 2021 and 2022. Main Outcomes and Measures: Patient demographic, clinical, and insurance data and OACD delivery dates were collected. The reasons for a failure to receive a prescribed OACD within 3 months were confirmed by manual review of medical records and were classified into 7 categories: clinical deterioration, financial access, clinician-directed change in decision-making, patient-directed change in decision-making, transfer of care, loss to follow-up, and unknown or other. A multivariable random-effects model was developed to identify factors associated with failure to receive a prescribed OACD. Results: The cohort included 1024 patients (538 men [53%]; mean [SD] age, 66.2 [13.9] years; 463 non-Hispanic White patients [45%], 140 non-Hispanic Black patients [14%], and 300 Hispanic patients [29%]), representing 1197 new OACD prescriptions. Of the 1197 prescriptions, 158 (13%) were categorized as having not been received by the patient. The most common reason for the failure to receive a prescribed OACD was due to patient and clinician decision-making (73 of 158 [46%]), and 20 cases (13%) in which prescriptions were not received were associated with financial access issues. In multivariable analysis, patients with a nonmetastatic solid malignant neoplasm were significantly less likely to not receive their OACDs than those with a hematologic malignant neoplasm (odds ratio, 0.57 [95% CI, 0.33-1.00]; P = .048). Conclusions and Relevance: This cohort study of patients prescribed a new OACD found that 13% of prescriptions were not received. The failure to receive a prescribed OACD was most frequently due to a change in clinical decision-making or patient choice. Ultimately, the reasons for the failure to receive a prescribed OACD were multifactorial and may have been appropriate in some cases.

Performance status and end-of-life care among adults with non-small cell lung cancer receiving immune checkpoint inhibitors.

BACKGROUND: Adults with impaired performance status (PS) often receive immune checkpoint inhibitors (ICIs) for advanced non-small cell lung cancer (NSCLC) despite limited efficacy data and unknown effects on end-of-life care. METHODS: This was a retrospective, single-site study of 237 patients with advanced NSCLC who initiated ICI treatment from 2015 to 2017. Cox regression was used to compare the overall survival (OS) of patients who had impaired PS (≥2) at the start of ICI treatment with those who had PS 0 or 1 using Cox regression. Logistic regression was conducted to analyze the association between ICI use in the last 30 days of life and the use of end-of-life health care. RESULTS: The patient mean age at ICI initiation was 67 years (range, 37-91 years), and 35.4% of patients had PS ≥2. Most patients (80.8%) received ICI as second-line or later therapy. The median OS was 4.5 months in patients with PS ≥2 and 14.3 months in those with PS 0 or 1 (hazard ratio, 2.5; P < .0001). Among the patients who died (n = 184), 28.8% who had PS ≥2 received ICIs in their last 30 days of life compared with 10.8% of those who had PS 0 or 1 (P = .002). Receipt of ICI in the last 30 days of life was associated with decreased hospice referral (odds ratio, 0.29; P = .008) and increased in-hospital deaths (odds ratio, 6.8; P = .001), independent of PS. CONCLUSIONS: Adults with advanced NSCLC and impaired PS experience significantly shorter survival after ICI treatment and receive ICIs near death more often than those with better PS. Receipt of an ICI near death was associated with lower hospice use and an increased risk of death in the hospital. These results underscore the need for high-quality communication about potential tradeoffs of ICIs, particularly among adults receiving ICIs as second-line or later therapy.

Impact of Age on Outcomes with Immunotherapy in Patients with Non-Small Cell Lung Cancer.

INTRODUCTION: Immunotherapy has revolutionized the treatment of NSCLC, but little is known about the activity of programmed cell death 1 and programmed death ligand 1 blockade across age groups. METHODS: We retrospectively evaluated patients with NSCLC who initiated programmed cell death 1 and programmed death ligand 1 inhibitors from January 2013 through July 2017. Medical records and radiographic imaging were reviewed to determine progression-free survival (PFS) and overall survival (OS). We also compared immunotherapy-related toxicities, steroid use, and hospitalizations by age. RESULTS: Of the 245 patients, 26.1% were younger than 60 years, 31.4% were age 60 to 69 years, 31.0% were age 70 to 79 years, and 11.4% were age 80 years or older. The median PFS times by age group were as follows: younger than 60 years, 1.81 months; age 60 to 69 years, 2.53 months; age 70 to 79 years, 3.75 months; and age 80 years or older, 1.64 months (log-rank p value = 0.055). The median OS times by age group were as follows: younger than 60 years, 13.01 months; age 60 to 69 years, 14.56 months; age 70 to 79 years, 12.92 months; and age 80 years or older, 3.62 months (log-rank p value = 0.011). Rates of immunotherapy-related toxicities, steroid use, and hospitalizations did not differ by age. CONCLUSIONS: Although the OS and PFS benefits of immunotherapy differ by age, the rates of toxicity are similar regardless of age.

National Guidelines for Colorectal Cancer Screening in Saudi Arabia with strength of recommendations and quality of evidence

BACKGROUND: Colorectal cancer is the most common cancer among Saudi men and the third commonest among Saudi women. Given the predominance of colorectal cancer compared with other cancers in Saudi Arabia, context-specific guidelines are needed for screening. METHODS: Experts from the Saudi Society of Colon and Rectal Surgery, Saudi Gastroenterology Association, Saudi Oncology Society, Saudi Chapter of Enterostomal Therapy, Family Medicine and Department of Public Health at the Saudi Arabian Ministry of Health and a patient advocate was assembled by the Saudi Centre for Evidence-Based Healthcare, a subsidiary of the Saudi Arabian Ministry of Health. The panel collaborated with a methodological team from McMaster University, Canada to develop national guidelines for colorectal cancer screening. After identifying key questions, the panel conducted a systematic review of all reports on the utility of screening, the cost of screening for colorectal cancer in Saudi Arabia and on the values and preferences of Saudi patients. Meta- analyses, when appropriate, were performed to generate pooled estimates of effect. Using the GRADE approach, the panel used the evidence-to-decision (EtD) framework to assess all domains important in determining the strength and direction of the recommendations (benefits and harms, values and preferences, resource implications, equity, acceptability, and feasibility). Judgments related to the EtD domains were resolved through consensus or voting, if consensus was not reached. The final recommendations were developed during a two-day meeting held in Riyadh, Saudi Arabia in March 2015. Conflicts of interests among the panel members were handled according to the World Health Organization rules. LIMITATIONS: There is lack of national data on the incidence of adenomatous polyps or the age groups in which the incidence surges. There were no national clinical trials assessing the effectiveness of the different modalities of screening for colorectal cancer and their impact on mortality. CONCLUSION: The panel recommends screening for colorectal cancer in Saudi Arabia in asymptomatic Saudi patients at average risk of colorectal cancer. An infrastructure should be built to achieve that goal.(AU)

Creep behavior of bone cement: a method for time extrapolation using time-temperature equivalence.

The clinical lifetime of poly(methyl methacrylate) (PMMA) bone cement is considerably longer than the time over which it is convenient to perform creep testing. Consequently, it is desirable to be able to predict the long term creep behavior of bone cement from the results of short term testing. A simple method is described for prediction of long term creep using the principle of time-temperature equivalence in polymers. The use of the method is illustrated using a commercial acrylic bone cement. A creep strain of approximately 0.6% is predicted after 400 days under a constant flexural stress of 2 MPa. The temperature range and stress levels over which it is appropriate to perform testing are described. Finally, the effects of physical aging on the accuracy of the method are discussed and creep data from aged cement are reported.

MOC-31 aids in the differentiation between adenocarcinoma and reactive mesothelial cells.

BACKGROUND: Evaluation of effusion specimens for the presence of adenocarcinoma often is complicated by the presence of reactive mesothelial cells that can mimic adenocarcinoma. Ancillary studies, in particular immunohistochemistry, can be helpful in making this distinction. MOC-31 is an antibody that recently was reported to be useful in distinguishing adenocarcinoma from mesothelioma in tissue specimens. In this study we examined the utility of this antibody in pleural effusions. METHODS: Eighty-nine archival, formalin fixed, paraffin embedded cell blocks representing 59 adenocarcinomas, 12 other neoplasms (including 6 mesotheliomas), and 18 reactive effusions were retrieved. After protease digestion, recut slides were immunostained with the MOC-31 antibody utilizing a modified avidin-biotin complex technique. Only membrane-based reactivity was considered as positive. RESULTS: In two adenocarcinomas there was insufficient material remaining in the cell block. Among the 57 remaining cases, reactivity was observed in 54 cases. Reactivity also was observed in one of six mesotheliomas and one small cell carcinoma. The remaining cases, including all 18 reactive effusions, were nonreactive. In distinguishing adenocarcinoma from reactive mesothelial cells, the presence of MOC-31 reactivity was found to be 95% sensitive and 100% specific with a positive predictive value of 100% and a negative predictive value of 95%. CONCLUSIONS: MOC-31 is useful in differentiating between adenocarcinoma and reactive mesothelial cells in pleural effusion specimens. Cancer (Cancer Cytopathol)

Characterization of labeled oligonucleotides using enzymatic digestion and tandem mass spectrometry.

A simple and powerful method for the determination of labeling sites on oligodeoxynucleotides (ODN) has been developed. The method is based on the finding that nuclease P1 (NP1) digestions of label-containing ODNs produce site-specific products: 5'-labeled ODNs produce label-nucleotide (L-N); 3'-labeled ODN produces phosphorylated label (pL); and a label in between the ODN termini produces pL-N. Mass spectrometry spectra of these products from the digestion mixture can be easily utilized for structural verification of labeled ODNs such as DNA probes. We also developed a method for the determination of the labeling sites of ODNs with unknown label structures. In this method, NP1 digestion products generate site-specific fragmentation patterns upon collision-induced dissociation. These patterns can be easily recognized and used for the identification of labeling sites of ODNs with unknown label structures. When an ODN is internally labeled, phosphodiesterase digestion may be used to determine the exact labeling site (sequence location). It was demonstrated that these methods can be applied for ODNs with single or multiple labels, and for ODNs with the same or different labels within an ODN.

Common wrist injuries.

Patients with wrist injuries often present to primary care physicians. Many times, mild clinical injury involves significant damage to carpal bones and soft tissue elements. The long-term outcome of these injuries depends on prompt diagnosis and appropriate therapy. Familiarity with the functional anatomy and physical examination of the wrist, accompanied by radiologic evaluation, may aid the physician in differentiating simple sprains from potentially debilitating wrist injuries.

Effect of composting poultry carcasses on survival of exotic avian viruses: highly pathogenic avian influenza (HPAI) virus and adenovirus of egg drop syndrome-76.

Eight-week-old chickens were inoculated with one of two exotic viruses to determine the effect of composting on virus survival. Group 1 chickens were inoculated with highly pathogenic avian influenza (HPAI) virus via the caudal thoracic air sac. Group 2 chickens were inoculated with the adenovirus that causes egg drop syndrome-76 (EDS-76) by the oral route. Five days after inoculation, lung, trachea, and air sacs for HPAI and spleen, cecal tonsils, and bursa of Fabricius for EDS-76 were collected and composted with poultry carcasses. At the end of the first 10 days of composting, virus-isolation efforts showed that the HPAI virus had been inactivated, and only 1 of 20 tissue samples yielded the adenovirus of EDS-76. The viruses of HPAI and EDS-76 were completely inactivated at the end of the second 10-day period of the two-stage composting process. Control tissues collected at necropsy and frozen at -70 C for virus isolation were all positive for virus.

Detection of HCV RNA by the asymmetric gap ligase chain reaction.

The ligase chain reaction (LCR) and the gap ligase chain reaction (gLCR) are exponential amplification techniques for the detection of DNA sequences in a sample. Both techniques depend on the enzyme, DNA ligase, to join adjacent probes annealed to a DNA molecule. However, DNA ligase joins DNA inefficiency on an RNA target. Consequently, LCR and gLCR cannot amplify RNA efficiency. RNA detection methods using LCR or gLCR require a cDNA synthesis step. The carryover of four dNTPs from the cDNA reaction inhibits gLCR. Although LCR can use cDNA reaction products directly, background generated by blunt-end ligation does not allow the high sensitivity typically needed for HIV or HCV detection. The asymmetric gap ligase chain reaction (AGLCR) is a modification of gLCR that allows for the detection of RNA by using < or = 3 of the 4 nucleotides in the cDNA step and the gLCR step. Fewer than 50 copies of synthetic RNA transcript can be reproducibly detected. HCV, an RNA virus with no DNA intermediate, was chosen as the initial RNA model system. HCV antibody-positive and normal samples were analyzed, and the results were found to correlate with the results obtained using nested RNA-PCR. AGLCR provides a new nucleic acid amplification technique that can aid in the diagnosis of disease when the detection of RNA is critical.

The case confessions of a pastoral visitor.

When a bungled catheterization following surgery causes a life-threatening hemorrhage, this Lutheran minister and hospital chaplain finds himself on the receiving end of professional pastoral care. Regretting the times in offered "Gospel platitudes and sugar-coated Bible verses" to suffering patients, the author finds that his experience has brought him closer to God's presence and made him a better minister.

Base composition analysis of oligonucleotides containing apurinic sites.

Upon base composition analysis, oligonucleotides which are labeled at the 3'-terminus with fluorescein or biotin generate an additional, late eluting peak in the HPLC chromatogram. Investigation of this effect revealed the haptens acted as apurinic sites, and phosphodiesterase cleavage of the phosphate bond between the upstream nucleotide and apurinic site is inhibited. Extension of this work with a base-stable apurinic site inserted into all possible junctures of 5'-TGAC-3' tetramers showed this to be a general effect. As a consequence of this work, acid-catalyzed depurination resulting in apurinic sites can be monitored in oligonucleotide synthesis.

Effects of video-assisted training on employment-related social skills of adults with severe mental retardation.

Two studies investigated effects of video-assisted training on employment-related social skills of adults with severe mental retardation. In video-assisted training, participants discriminated a model's behavior on videotape and received feedback from the trainer for responses to questions about video scenes. In the first study, 3 adults in an employment program participated in video-assisted training to request their supervisor's assistance when encountering work problems. Results indicated that participants discriminated the target behavior on video but effects did not generalize to the work setting for 2 participants until they rehearsed the behavior. In the second study, 2 participants were taught to fix and report four work problems using video-assisted procedures. Results indicated that after participants rehearsed how to fix and report one or two work problems, they began to fix and report the remaining problems with video-assisted training alone.