Impact of COVID-19 Pandemic on Non-Small Cell Lung Cancer Care.

We assessed the impact of COVID-19 on healthcare visits, timing of stage IV NSCLC diagnosis and immunotherapy initiation, and rates of switching to extended dosing schedules of immunotherapies among patients with stage IV NSCLC. This retrospective study examined electronic health record data of adult patients receiving treatment for stage IV NSCLC within The US Oncology Network and Onmark. Endpoints were compared for February-July 2019 (before COVID) vs. February-July 2020 (during COVID). The study found rapid decreases in numbers of patients with clinic/vital visits, immunotherapy initiations, and new diagnoses of stage IV NSCLC during April-May 2020 vs. April-May 2019. The rate of delays of immunotherapy administrations and proportions of patients with such delays increased from February to March of 2020. These patterns may have resulted from the increase in COVID-19 cases during this period and the corresponding quarantine and lockdowns. However, when comparing pre COVID-19 and during COVID-19 for May and after, the differences in delay of immuno-oncology administrations became less marked, likely due to lifting of lockdowns. The rate of switching from shorter to longer dosing schedules increased from May-July 2020. This was mainly attributed to pembrolizumab, likely due to FDA approval of the pembrolizumab 6W dosing schedule in April 2020.

Cyclic GAN Model to Classify Breast Cancer Data for Pathological Healthcare Task.

An algorithm framework based on CycleGAN and an upgraded dual-path network (DPN) is suggested to address the difficulties of uneven staining in pathological pictures and difficulty of discriminating benign from malignant cells. CycleGAN is used for color normalization in pathological pictures to tackle the problem of uneven staining. However, the resultant detection model is ineffective. By overlapping the images, the DPN uses the addition of small convolution, deconvolution, and attention mechanisms to enhance the model's ability to classify the texture features of pathological images on the BreaKHis dataset. The parameters that are taken into consideration for measuring the accuracy of the proposed model are false-positive rate, false-negative rate, recall, precision, and F1 score. Several experiments are carried out over the selected parameters, such as making comparisons between benign and malignant classification accuracy under different normalization methods, comparison of accuracy of image level and patient level using different CNN models, correlating the correctness of DPN68-A network with different deep learning models and other classification algorithms at all magnifications. The results thus obtained have proved that the proposed model DPN68-A network can effectively classify the benign and malignant breast cancer pathological images at various magnifications. The proposed model also is able to better assist the pathologists in diagnosing the patients by synthesizing the images of different magnifications in the clinical stage.

Intrathecal Drug Delivery Systems Survey: Trends in Utilization in Pain Practice.

Background: The use of intrathecal drug delivery for chronic and cancer pain medicine has been established for decades. However, optimization and utilization of this technique still lag behind other modalities for pain control. Some of this may be due to variability of surgical technique, medication usage and education. It is currently unclear on whether or not practitioners follow available algorithms for the use of intrathecal drug delivery systems. Methods: A survey developed by the American Society of Pain and Neuroscience (ASPN) was sent to its members via email using the cloud-based SurveyMonkey. After 30 days of being available, 159 different providers responded to the survey that consisted of 31 various multiple choice and free response questions. Each question was not required and the number of responses to each varied from 128 to 159. Results: Approximately 9% of those who successfully received and opened the email containing the survey responded, likely due to a small number of providers working with intrathecal drug delivery systems. Eighty-six of respondents practice medicine in the United States, and 87% of the respondents were attending physicians. A majority of respondents, approximately 74%, were board certified in pain medicine with 69% of respondents being train in anesthesiology. The first and second most used medications for intrathecal pump trial were morphine and fentanyl, respectively. Most respondents, approximately 96%, provide pre-operative/intra-operative antibiotics. The most common first-choice medication for implanted intrathecal pumps was also morphine with the most common implanted location being the abdomen. Conclusion: Interestingly, there is currently fairly substantial variation in the way providers utilize intrathecal pump delivery for both chronic and cancer pain. There is variation from the training background of the providers providing care, to the pre-implantation trial medications, to where the pump is implanted for each patient, to if the patient has the option to give themselves boluses once implanted. Further research is needed to elucidate current and best practices for intrathecal drug delivery system trials, implantations, and utilization.

An International Survey on the Practice of Lumbar Radiofrequency Ablation for Management of Zygapophyseal (Facet)-Mediated Low Back Pain.

Objective: The objective of this study was to survey current clinical practice related to lumbar radiofrequency (RFA) for the treatment of zygapophyseal (facet)-mediated low back pain. Methods: Survey questions regarding the clinical practice of lumbar RFA were created and piloted by the American Society of Pain and Neuroscience (ASPN) leadership. After revision for clarity, health-care professionals worldwide who hold membership status within the ASPN Society and who offer lumbar RFA in their clinical practice were recruited to participate in this online survey. All responses were tabulated and summarized descriptively. Results: A total of 329 participants responded in the survey. Most participants specialized in anesthesiology (68.4%) and physical medicine and rehabilitation (21.8%) and had been practicing pain management for more than five years (70.5%). Of physician respondents, 27.5% did not complete an Accreditation Council for Graduate Medical Education (ACGME)-accredited pain medicine fellowship and 16.5% were not board-certified in pain medicine. The majority of providers (69.7%) reported that they perform two diagnostic medial branch blocks prior to proceeding with lumbar RFA. Bupivacaine 0.5% was the most common medication utilized for both the first (37.4%) and second (37.1%) diagnostic blocks. There were 32.6% of total respondents who reported not utilizing contrast dye when performing diagnostic blocks. The vast majority of providers (91.4%) reported using conventional RFA for lumbar medial branch neurotomy. Conclusion: This survey study provides a summary of the application of lumbar RFA for the treatment of axial low back pain in the real-world setting. We highlight a significant portion of providers who perform lumbar RFA yet do not have pain fellowship training at an ACGME-accredited institution or do not maintain current pain medicine board certification. We also report deviations from standard practice, specifically the type of local anesthetic used for comparative diagnostic blocks and the omission of contrast injection during diagnostic blocks.

Erenumab for episodic migraine.

In this review, the authors provide an overview of erenumab, a monoclonal antibody used for the preventative treatment of episodic migraine by targeting the CGRP pathway. Randomized controlled trials have shown that erenumab is associated with a statistically significant decrease in monthly migraine days in patients with episodic migraine at monthly doses of 70 or 140 mg when given for a period of 9-12 weeks. Post hoc analyses have also shown long-term maintenance of efficacy. Clinical trials have found erenumab at doses of both 70 and 140 mg to have a favorable safety profile. Erenumab faces significant limitations because of its high financial cost. Additional long-term real-world data are needed to understand the role of erenumab in the treatment of migraine.

In this review, the authors give an overview of erenumab, an injectable medication used to prevent migraine headaches. Erenumab has been proven to be significantly effective in patients with episodic migraines when used at doses of 70 or 140 mg. Furthermore, studies have shown sustained benefit starting as early as the first week of treatment as well as improvement in patients' quality of life. Erenumab has been found to be as safe as placebo in some studies, but there have been some reports of a link to high blood pressure and constipation. However, because of its high cost, patients still face significant barriers to access to erenumab. Additional long-term real-world data are needed to understand the current role of erenumab in the treatment of migraine.

A narrative review and future considerations of spinal cord stimulation, dorsal root ganglion stimulation and peripheral nerve stimulation.

PURPOSE OF REVIEW: In recent years, neuromodulation has experienced a renaissance. Novel waveforms and anatomic targets show potential improvements in therapy that may signify substantial benefits. New innovations in peripheral nerve stimulation and dorsal root ganglion stimulation have shown prospective evidence and sustainability of results. Sub-perception physiologic bursting, high-frequency stimulation and feedback loop mechanisms provide significant benefits over traditional tonic spinal cords stimulation (SCS) in peer reviewed investigations. We reviewed the themes associated with novel technology in the context of historical stalwart publications. RECENT FINDINGS: New innovations have led to better nerve targeting, improvements in disease-based treatment, and opioid alternatives for those in chronic pain. In addition, new neural targets from both structural and cellular perspectives have changed the field of Neurostimulation. SUMMARY: For many years, tonic SCS was representative of neuromodulation, but as this review examines, the progression of the field in the past decade has reshaped patient options.

Minimally invasive lumbar decompression: a review of indications, techniques, efficacy and safety.

Lumbar spinal stenosis is a common degenerative spine condition. In properly selected patients, minimally invasive lumbar decompression (mild®) may be an option to improve outcomes. This review provides an in-depth description of the mild procedure and a comprehensive examination of safety and efficacy. Two randomized controlled trials, together with 11 other controlled clinical studies, have established the efficacy of mild, which is a minimally invasive procedure that does not involve implants and has demonstrated excellent efficacy and safety. With an established safety profile equivalent to epidural steroid injections, and efficacy that has been shown to be superior to such injections, mild can reasonably be positioned early in the treatment algorithm for these patients. Based on extensive review of the literature, robust safety and efficacy through 2 years, and in accordance with minimally invasive spine treatment guidelines, mild is recommended as the first intervention after failure of conservative measures for lumbar spinal stenosis patients with neurogenic claudication and ligamentum flavum hypertrophy.

Intrathecal drug delivery for pain management: recent advances and future developments.

Introduction: Chronic pain conditions of malignant and non-malignant etiology afflict a large group of the population and pose a vast economic burden on society. Intrathecal drug therapy is a viable treatment option in such patients who have failed conservative medical measures and less invasive pain management procedures. However, the clinical growth of intrathecal therapy in managing intractable chronic pain conditions continues to face many challenges and is likely underutilized secondary to its high-complexity and lack of understanding. Areas covered: This review will briefly discuss the history of intrathecal drug delivery systems (IDDS), cerebrospinal fluid (CSF) flow dynamics, types of IDDS, indications and patient profile suitable for this therapy, and risks and complications related to IDDS. We will also discuss challenges faced by physicians utilizing this therapy and the future changes that are needed for making this treatment modality more efficacious. Expert opinion: IDDS offer an effective therapy for pain control in patients suffering from chronic intractable pain conditions. These devices provide a safer alternative to oral opioid medications with reduced systemic side effects. Adherence to best practices and continued clinical and basic science research is important to ensure continuing success of this therapy.

HER2-Positive Metastatic Breast Cancer Patients Receiving Pertuzumab in a Community Oncology Practice Setting: Treatment Patterns and Outcomes.

BACKGROUND: Pertuzumab (Perjeta®), a HER2/neu receptor antagonist, was approved by the US Food and Drug Administration in June 2012 for use in the first-line setting for patients with HER2-positive metastatic breast cancer (mBC). OBJECTIVE: This retrospective study investigated the clinical and demographic characteristics, treatment patterns, safety, and clinical outcomes for patients with HER2-positive mBC who received pertuzumab in the first-line setting in US community oncology practices. METHODS: Patients with HER2-positive mBC, who initiated pertuzumab within 60 days of mBC diagnosis between June 2012 and June 2014, followed through December 2014, had ≥2 visits within the McKesson Specialty Health/US Oncology Network, and were not on clinical trials during the study period, were eligible. This study utilized iKnowMed electronic health records, Claims Data Warehouse, and Social Security Death Index. Progression-free survival (PFS) was assessed by Kaplan-Meier methods. RESULTS: A total of 266 patients met the selection criteria. A vast majority of the patients (249/266, 93.6%) received a trastuzumab + pertuzumab + taxane (H + P + T) regimen. The number of patients with prior adjuvant/neoadjuvant therapy was higher than the CLEOPATRA trial, but age (median 57 years) and percentage of visceral disease (74.8%) were similar. The most common adverse events were fatigue (50.8%), diarrhea (44.7%), nausea (35.3%), peripheral neuropathy (33.5%), neutropenia (24.9%), and rash (24.4%). The median PFS was 16.9 months (95% CI 14.2-19.7). CONCLUSIONS: In this retrospective study of patients with HER2-positive mBC receiving pertuzumab in the first-line setting, most patients were treated with H + P + T. The safety and PFS of H + P + T were consistent with those observed in the pivotal trial.

Dexmedetomidine provides optimum conditions during awake fiberoptic intubation in simulated cervical spine injury patients.

BACKGROUND AND AIMS: We undertook this study to assess if a small-dose of dexmedetomidine (DEX) for conscious sedation during awake fiberoptic intubation (AFOI) in simulated cervical spine injury (CSI) patients provides optimum conditions and fulfills the need of postintubation neurological examination required in such patients. The aim was to assess the efficacy of DEX on arousability and patient's comfort during AFOI in simulated CSI patients. MATERIAL AND METHODS: In this prospective, randomized double-blind study, 100 American Society of Anesthesiologists Grade I-II patients aged between 18 and 65 years scheduled for elective surgery under general anesthesia underwent AFOI under conscious sedation with DEX. After locally anesthetizing the airway and applying a cervical collar, patients either received DEX 1 µg/kg over 10 min followed by 0.7 µg/kg/h maintenance infusion or normal saline in the same dose and rate during AFOI. Targeted sedation (Ramsay sedation score [RSS] ≥2) during AFOI was maintained with midazolam [MDZ] in both groups. Statistical Analysis was performed using unpaired Student's t-test, Chi-square test, Mann-Whitney test and Wilcoxon-w test. RESULTS: The total number of patients requiring MDZ and the mean dose of MDZ required to achieve targeted sedation (RSS ≥2) was significantly less in DEX group compared to the placebo group (P < 0.001). Similarly, patient satisfaction score, heart rate, systolic, diastolic and mean arterial pressure and respiratory parameters were significantly better in DEX group (P < 0.001). Postintubation arousability in the two groups was comparable (P = 0.29). CONCLUSIONS: Dexmedetomidine provides optimum sedation without compromising airway or hemodynamic instability with better patient tolerance and satisfaction for AFOI. It also preserves patient arousability for the postintubation neurological assessment.

Burden of illness among patients with fragile X syndrome (FXS): a Medicaid perspective.

BACKGROUND: Fragile X syndrome (FXS) is an inherited intellectual disability that imposes a substantial clinical and humanistic burden on patients and caregivers. This study aimed to quantify the incremental burden of illness following FXS diagnosis in Medicaid populations. METHODS: A retrospective matched-cohort study was conducted using FL, NJ, MO, IA, and KS Medicaid claims (1997-2012). Patients with FXS were matched 1:5 to a comparison group without FXS, based on age, gender, state, and continuous Medicaid coverage. Healthcare resource utilization and costs were compared among cohorts over 1 year following first diagnosis. RESULTS: Overall, 697 patients with FXS were matched to 3485 non-FXS patients. Median age was 12.0 years; 82% were male. Newly diagnosed FXS patients were younger (median age: 7.0 years). During the follow-up, patients with FXS had significantly higher medication use, medical procedure use, medical specialist visits, and associated costs than the non-FXS comparison group. One-fourth of FXS patients filled prescriptions for stimulants, antipsychotics, or anticonvulsants; 25% of patients with FXS had speech and language therapy and 39% had physical therapy (versus 9%, 4% and 8%, respectively, for the comparison group). At least 44% of FXS patients visited a neurologist, cardiologist, otolaryngologist, or gastroenterologist; 92% of patients with FXS had an outpatient visit, 35% had an emergency room visit, and 34% used home services (compared to 31%-32%, 64%, 27%, and 10%, respectively, for the comparison group) (all p < 0.05). Patients with FXS had an incremental annual total healthcare cost of $33,409 (2012$) per person relative to the comparison group, while newly diagnosed FXS patients had incremental total annual healthcare costs of $17,617 (2012$) per person. CONCLUSIONS: Both established and newly diagnosed FXS were associated with significantly increased use of multiple medications and medical services, and increased healthcare costs. Treatments that could help reduce this disease burden are urgently needed.

Health resource use and costs of vilazodone and other selective serotonin re-uptake inhibitors in treating major depressive disorder.

OBJECTIVE: Selective serotonin re-uptake inhibitors (SSRIs) are widely prescribed antidepressants. This claims database study compared healthcare resource use and costs among patients with major depressive disorder (MDD) treated with vilazodone vs other SSRIs. METHODS: Adults with an MDD diagnosis and ≥ 1 prescription fill for vilazodone, citalopram, escitalopram, fluoxetine, paroxetine, or sertraline were identified from administrative claims data (2010-2012). Patients who concomitantly used adjunctive medication, either a second-generation antidepressant or antipsychotic, were excluded. All-cause and MDD-related healthcare resource use and costs (in 2012 USD) were compared between patients treated with vilazodone vs other SSRIs over a 6-month follow-up period using unadjusted and multivariable analyses. RESULTS: The study cohort included 49 861 patients (mean age = 44.0 years; 70% female). Compared with the vilazodone cohort (n = 3527), patients in the citalopram (n = 12 187), escitalopram (n = 8275), fluoxetine (n = 10 142), paroxetine (n = 3146), and sertraline (n = 12 584) cohorts had significantly more all-cause inpatient hospital visits, longer hospital stays and more frequent emergency department visits, following the index date, after adjusting for baseline characteristics. All-cause medical service costs (inpatient + outpatient + emergency department visits) were significantly higher across all other SSRI cohorts vs vilazodone by $758-$1165 (p < 0.05). Similarly, all-cause total costs, were significantly or numerically (non-significantly) higher across all SSRI cohorts vs vilazodone by $351-$780. LIMITATIONS: The was no clinical measurement of disease severity, partial coverage of the Medicare-eligible population, and short follow-up. CONCLUSION: MDD treatment with vilazodone was associated with significantly lower rates of inpatient and emergency services, and with significantly lower all-cause medical service costs and numerically (non-significantly) lower total costs to payers than with the other SSRIs included in this study.

A prospective observational study of skin to subarachnoid space depth in the Indian population.

BACKGROUND AND AIMS: A pre-puncture estimate of skin to subarachnoid space depth (SSD) may guide spinal needle placement and reduce complications associated with lumbar puncture. Our aim was to determine (1) The SSD in Indian males, females, parturients and the overall population; (2) To derive formulae for predicting SSD and (3) To determine which previously suggested formula best suited our population. METHODS: In this prospective, observational study, 800 adult Indian patients undergoing surgery under spinal anaesthesia were divided into three groups: Males (Group M), females (Group F) and parturients (Group PF). SSD was measured after lumbar puncture. The relationship between SSD and patient characteristics was studied and statistical models were used to derive formula for predicting SSD. Statistical analysis included One-way ANOVA with post hoc analysis, forward stepwise multivariate regression analysis and paired t-tests. RESULTS: Mean SSD was 4.71 ± 0.70 cm in the overall population. SSD in adult males (4.81 ± 0.68 cm) was significantly longer than that observed in females (4.55 ± 0.66 cm) but was comparable with SSD in parturients (4.73 ± 0.73 cm). Formula for predicting SSD in the overall population was 2.71 + 0.09 × Body Mass Index (BMI). Stocker's formula when applied correlated best with the observed SSD. Formulae were derived for the three groups. CONCLUSIONS: We found gender-based differences in SSD, with SSD in males being significantly greater than that observed in the female population. SSD correlated with BMI in the parturient and the overall population. Amongst the previously proposed formulae, Stocker's formula was most accurate in predicting SSD in our population.

Low dose intrathecal clonidine and fentanyl added to hyperbaric bupivacaine prolongs analgesia in gynecological surgery.

BACKGROUND: We undertook this study to ascertain if a small dose of clonidine (30 µg) when added to a bupivacaine-fentanyl mixture improves spinal analgesia, without producing side effects, as compared to a bupivacaine-fentanyl or a bupivacaine-clonidine mixture. MATERIALS AND METHODS: In this prospective, randomized, double-blind study, 75 (American Society of Anesthesiologists) ASA grade I-II patients, aged between 45 and 65 years, who were scheduled for vaginal hysterectomy with pelvic floor repair or non-descent vaginal hysterectomy under spinal anesthesia were recruited. The patients received hyperbaric bupivacaine (2.3 ml) with fentanyl 15 µg (Group BF) or clonidine 30 µg (Group BC) or both fentanyl (15 µg) and clonidine (30 µg) (Group BCF). The total amount of intrathecal mixture was constant (2.8 ml) in all the groups. Duration of sensory, motor block and effective analgesia, hemodynamic profile, postoperative pain score and analgesic requirements were recorded. RESULTS: The duration of effective analgesia, mean time till two-segment regression, and duration of sensory and motor block were significantly longer in group BCF as compared to group BC (P ~ 0.002), and in group BC as compared to group BF (P ~ 0.01). The incidence of intraoperative pain and requirement of postoperative analgesics in the first 24 hours was significantly more in group BF as compared to the other groups (P ~ 0.01). There was no difference in the hemodynamic profile between the groups. CONCLUSION: Low-dose clonidine (30 µg) when added to a bupivacaine-fentanyl mixture increased the duration of effective analgesia and the duration of sensory and motor block in gynecological surgery. The incidence of intraoperative pain and requirement of postoperative analgesics was significantly less when clonidine was added to intrathecal bupivacaine with or without fentanyl.

Pulmonary medication adherence and health-care use in cystic fibrosis.

BACKGROUND: Poor treatment adherence is common in cystic fibrosis (CF) and may lead to worse health outcomes and greater health-care use. This study evaluated associations of adherence to pulmonary medications, age, health-care use, and cost among patients with CF. METHODS: Patients with CF aged ≥ 6 years were identified in a national commercial claims database. A 12-month medication possession ratio (MPR) was computed for each pulmonary medication and then averaged for a composite MPR (CMPR) for each patient. The CMPR was categorized as low (< 0.50), moderate (0.50-0.80), or high (≥ 0.80). Annual health-care use and costs were measured during the first and second year and compared across adherence categories by multivariable modeling. RESULTS: Mean CMPR for the sample (N = 3,287) was 48% ± 31%. Age was inversely related to CMPR. In the concurrent year, more CF-related hospitalizations were observed among patients with low (event rate ratio [ERR], 1.35; 95% CI, 1.15-1.57) and moderate (ERR, 1.25; 95% CI, 1.05-1.48) vs high adherence; similar associations were observed for all-cause hospitalizations and CF-related and all-cause acute care use (hospitalizations + ED) in the concurrent and subsequent year. Rates of CF-related and all-cause outpatient visits did not differ by adherence. Low and moderate adherence predicted higher concurrent health-care costs by $14,211 ($5,557-$24,371) and $8,493 (-$1,691 to $19,709), respectively, compared with high adherence. CONCLUSIONS: Worse adherence to pulmonary medications was associated with higher acute health-care use in a national, privately insured cohort of patients with CF. Addressing adherence may reduce avoidable health-care use.

Magnetic resonance imaging of the pediatric liver: benign and malignant masses.

Hepatic neoplasms constitute approximately 5% to 6% of all pediatric intra-abdominal masses, most of which are malignant. When compared with traditional multiphase computed tomography protocols that are often used in adults, magnetic resonance (MR) imaging is particularly desirable for evaluating liver lesions in children because of the lack of ionizing radiation and superb soft tissue contrast resolution. The goal of this article is to discuss common benign and malignant pediatric hepatic lesions and their key MR imaging findings. Particular emphasis is placed on the utility of new hepatocyte-specific contrast agents to narrow the differential diagnosis.

Economic burden of Pseudomonas aeruginosa infection in patients with cystic fibrosis.

OBJECTIVE: Chronic infection with Pseudomonas aeruginosa (PA) is the primary cause of pulmonary deterioration in cystic fibrosis (CF). This study describes healthcare costs and resource utilization among CF patients following PA infection in the US. METHODS: This retrospective study utilized data from MarketScan claims database. CF patients with an initial PA infection were identified, and their healthcare utilization, medical and pharmacy costs were extracted for 12 months, pre- and post-PA infection. Descriptive and pair-wise non-parametric statistical analyses compared healthcare utilization and costs before and after infection. RESULTS: Three hundred and fifty-eight CF patients met study criteria (mean age 20.1 years; 48% female). Mean annual per-patient costs following initial PA infection increased by an estimated $18,516 (outpatient: $3113; inpatient: $10,123; pharmacy: $4943). Overall healthcare costs were significantly higher (p < 0.0001) following PA infection, as were overall inpatient visits, outpatient visits, and unique prescriptions (p < 0.0001). CONCLUSIONS: PA infection in cystic fibrosis creates a significant economic burden and the cost is not uniformly distributed across the healthcare components. LIMITATIONS: Key limitations of this study include the absence of clinical parameters to characterize PA infections and data on indirect costs such as loss of productivity or caretaker-related burden.