Medical Charts Of Adult Patients Research Articles

Treatment patterns and clinical outcomes following endocrine resistance among with HER2-low metastatic breast cancer: Retrospective observational study.

e13069 Background: Endocrine therapy (ET) ± CDK 4/6 inhibitors is a common initial treatment for HR+/HER2-low (IHC 1+ or IHC2+/ISH-) metastatic breast cancer (mBC). However, many patients eventually progress on ET-based regimen and receive subsequent chemotherapy (CT). This study aimed to describe treatment patterns and outcomes following endocrine resistance among HR+/HER2-low mBC patients in U.S community oncology practices. Methods: Participating oncologists from Cardinal Health’s Oncology Provider Extended Network (OPEN) provided data from the medical charts of adult patients with HR+/HER2-low mBC who received at least two lines (2L) of systemic therapy, with first line (1L) initiated between Feb 19, 2016, and Dec 31, 2018. Analysis was performed among patients who received a subsequent chemotherapy (CT) after progression on their last observed line of ET-based regimen. Patient characteristics and treatment history were summarized descriptively. Kaplan-Meier analyses of treatment outcomes, including physician-reported real-world progression free survival (rwPFS), time to treatment response (TTR) and time to treatment discontinuation (TTD) were performed. Results: 150 HR+/HER2-low mBC patients who received subsequent chemotherapy after ET resistance were included [mean age: 61±11 years, 57.3% were white and 32.7% were black]. The proportion of patients who stopped ET after 1L, 2L and ≥3L of ET were 23.3% (n=35), 70.7% (n=106) and 6.0% (n=9), respectively. The mean duration of ET-based regimens was 29.7 (SD: 13.12) months. Among patients who stopped ET after 1L (n=35), most patients received fulvestrant + palbociclib (48.6%) in 1L prior to switching to CT. Among those who stopped ET after 2 or more lines (n=115), most patients received letrozole + palbociclib (57.4%) in 1L and fulvestrant (46.1%) in 2L. The most common CT regimen utilized was capecitabine (47.0%) followed by paclitaxel (28.0%). The median rwPFS on CT was 8.12 months (95% CI 7.36-9.24), with slightly shorter median rwPFS among those who stopped ET after 1L (7.82 months, 95% CI 7.07-9.53) vs. 2L+ (8.19 months, 95% CI 6.97-9.99). The median TTD of CT was 7.82 months (95% CI 7.07-8.61) and TTR was 4.96 months (95% CI 4.24-5.72), with similar estimates observed between patients who stopped ET after 1L and 2L+. Conclusions: In this small sample of HR+/HER2-low mBC patients, most patients switched to CT after receiving two lines of ET based regimens. Following ET resistance, durability of response with subsequent CT was short and similar irrespective of number of prior lines of ET based regimens. This preliminary chart review study highlights the unmet need for a more effective therapeutic alternative to CT after ET for HR+/HER2-low mBC patients. Further research using larger sample and more robust clinical data is warranted to confirm the study findings.

Incidence and nonunion rates of tibial fractures in adults with osteogenesis imperfecta: a retrospective cohort study of 402 patients with 42 fractures at an expert clinic

Tibial fractures are the most common fractures seen in adults and lead to the most nonunions. Osteogenesis imperfecta (OI) is characterized by increased bone fragility and higher risk of fractures. No studies have been published on the incidence of tibial fractures and nonunions in adults with OI. This study aims to summarize the incidence of tibial fractures and nonunions in this population. A retrospective, descriptive study. All medical charts of adult patients in the OI database of our OI expert clinic were analyzed for tibial fractures between 2008 and 2020. Tibial fracture incidence, nonunion rate, treatment modality and potential risk factors were determined. The database consisted of 402 patients, 34 of whom had suffered one or more tibial fractures, resulting in 42 fractures. The incidence of tibial fractures in adults with OI is 870 per 100,000 person-years. Two out of 42 fractures led to nonunion (5%). It was not possible to adjust for risk factors or type of treatment. There is a higher incidence of tibial fractures in patients with OI, but a nonunion rate comparable to the general population. With only two nonunions it is not possible to draw conclusions on the influence of risk factors or treatment of tibial fractures on OI.

Management of Adult Chiari I Patients Based on CSF Flow Magnetic Resonance Imaging: Experience of Two Neurosurgical Centers.

Chiari malformation type 1 (CM1) is one of the most discussed neurosurgical disorders. No consensus exists how to manage adult CM1 patients. We aimed to evaluate all adult CM1 patients consecutively managed at our institutions and discuss our approach based on the phase-contrast (PC) magnetic resonance imaging (MRI). The medical charts of adult patients diagnosed with CM1 at two referral neurosurgical centers between 2010 and 2017 were reviewed. The patients were either managed conservatively or surgically. We evaluated the patients clinically with the Chicago Chiari Outcome Scale (CCOS). The radiologic diagnosis was based on both craniocervical and PC-MRI. Ninety adult CM1 patients were managed conservatively. Conservative treatment failed in 5 of these 90 patients. Seventy-two patients (including those 5 patients who did not benefit from conservative treatment) underwent posterior fossa decompression with duraplasty. Eighty-five patients (94.4%) from the conservative group and 61 patients (84.7%) from the surgical group were treated successfully. An aqueductal stroke volume (ASV) value of 12 µL was found as the cutoff value for surgical candidates. A strong positive correlation between the increase in ASV values and clinical improvement was observed. PC-MRI can help in the management and follow-up of adult CM1 patients. Conservative management is possible in selected symptomatic CM1 patients with a high ASV (ASV > 15 µL). Surgery should be considered in patients with an ASV ≤ 12 µL. CM1 patients with ASV ≤12 to >15 μL require close follow-up. Long-standing symptoms, severe sleep apnea, symptoms influencing functionality, and syrinx are factors that affected outcomes negatively.

The Pattern of Thyroid Malignancy and Its Associated Characteristics Among United Arab Emirates Population With More Focus on Patients in the Bethesda III Category.

Introduction: Thyroid cancer is the most prevalent endocrine cancer worldwide. It is the second most common type of cancer among United Arab Emirates (UAE) women and ranks as the sixth most common type of cancer overall among the UAE population. There are limited studies in the UAE related to thyroid malignancy. This study aimed to determine the pattern of thyroid malignancy among the UAE population and its associated characteristics, with more emphasis on patients categorized as Bethesda III by cytopathology, and furthermore, to determine the significance of advanced diagnostic methods in the assessment of thyroid nodules.Methods: A retrospective review of the electronic medical charts of adult patients (age 18 and above) who were diagnosed with a thyroid nodule by ultrasound during the years 2019 and 2020. It is a comparative study of different variables associated with thyroid nodules and thyroid malignancy.Results: A total of 1072 patients were diagnosed with thyroid nodules upon initial ultrasound. We had 174 patients diagnosed with thyroid malignancy, constituting 16% (95% CI 0.14-0.19) of the total study population. 78% of the thyroid malignancy patients were women as compared to men, and this difference was statistically significant (p=0.042). Non-UAE nationals comprised 61% of the population diagnosed with thyroid malignancy (95% CI 1.37-2.68). Malignancy was found to be more common in patients with multinodular goiter, in the 30 to 39-year age group, and in patients with high ultrasound and Bethesda grades. From the total study population, 140 patients had cytology reports in the Bethesda III category. Thyroid malignancy was found in 30 patients with Bethesda III, and this comprised 17% of the total population who were diagnosed with thyroid malignancy.Conclusion: Despite being a single-center study, it highlights the percentage of thyroid malignancy and its associated factors among the UAE population. Thyroid ultrasound grading and Bethesda classification guide physicians in risk stratification, but it remains challenging in patients who fall into the Bethesda III category. Intervention versus regular follow-up should not depend on a single value but on the overall clinical picture and the use of advanced diagnostic methods.

Improving Health Equity by Screening for Poverty: A Survey of Family Physician Screening Behaviors and Perceptions in Toronto, Canada.

Purpose: Given the importance of socioeconomic status in both directly and indirectly influencing one's health, “poverty screening” by family physicians (FPs) may be one viable option to improve patient health. However, rates of screening for poverty are low, and reported barriers to screening are numerous. This study sought to collate and investigate reasons for refraining from screening among FPs, many of whom had opted into a Targeted Poverty Screening (TPS) Program, to be able to enhance uptake of the intervention. The TPS Program is a “targeted screening and referral process,” whereby medical charts of adult patients residing in “deprived neighborhoods,” as determined by postal code, were flagged for screening for FPs who elected to partake in the program.Methods: A survey containing 15 questions was developed through an iterative process with pilot-testing by faculty physicians. The survey was administered to FPs registered in the North York Family Health Team (NYFHT) using Qualtrics© research software.Results: Half of the respondents (n=19/38; 50%) indicated that they enrolled in the TPS program. Irrespective of enrollment in the TPS Program, the majority of respondents (n=31/38; 81.6%) stated that they elect to screen their patients for poverty using the evidence-based question of “do you have difficulty making ends meet at the end of the month?.” Among those not enrolled in the program, 84.2% (n=16/19) of respondents indicated that they screened their patients for poverty and 15.8% (n=3/19) indicated they did not. Among respondents who said they did not screen (n=7/38; 18.4%), the reasons for not screening patients were as follows: forgot (n=2; 28.6%); time constraints/feel uncomfortable asking (n=1; 14.3%); and “feel I know patients well” (n=1; 14.3%). For the remaining respondents, a nurse or locum did the screening as part of a periodic health review (i.e., patient was screened, but not by the FP completing the survey (n=3).Conclusion: This study yielded numerous insights, such as barriers faced by FPs in undertaking poverty screening that differs from the literature. The findings suggest that (1) barriers faced by FPs in poverty screening can be mitigated, (2) there is a need to integrate screening into routines and normalize the activity, and (3) there is a need for enhanced training to support patients of lower socioeconomic status.

Safety of Endoscopic Sinus Surgery in the Elderly-Are Octogenarian Patients at a Higher Risk?

Surgeons are often faced with concerns regarding the risks versus benefits of endoscopic sinus surgery (ESS) in elderly patients. To analyze the risk for complications of ESS in the elderly (age ≥70 years) compared to younger patients, with emphasis on octogenarians. Retrospective review of medical charts of adult patients who underwent ESS at a tertiary referral center during the years 2014 to 2018. We compared 128 elderly patients with 276 matched younger patients. In the elderly group mean age was 76 years (range, 70-91 years ). Thirty-one elderly patients were 80 years or older. Surgical complications in the elderly patients were 3.9%. Minor complications were 2.3% and major complications were 1.7%. The surgical complications rate was similar in the younger group (8%, P value: .127). Medical complications were observed in 2.3% comparing to 0.7% in younger patients. Interestingly, age, revision surgery, extent and duration of surgery, and modality of anesthesia were not identified as risk factors. Only ischemic heart disease (IHD) was identified as a risk factor for complications in a multivariate analysis in elderly patients. Comparison of elderly patients younger than 80 years with octogenarians revealed no difference in complication rate between these groups. Overall, ESS was found to be a safe procedure in elderly patients compared to younger patients. Octogenarian patients should not be denied upfront surgery. IHD is a risk factor for complications in elderly patients.

Toxicity Profile of PEG-Asparaginase in Adult Patients With Acute Lymphoblastic Leukemia in Brazil: A Multicenter Cross-Sectional Study

BackgroundCurrently, pediatric-inspired regimens are commonly applied to adults with acute lymphoblastic leukemia (ALL) after the recent recognition that these protocols improve survival. While asparaginase in whatever available formulation is a key component of modern treatment of ALL, many adult oncologists and hematologists struggle to deal with its particular toxicities in clinical practice. We reviewed toxicity outcomes of pegylated asparaginase (PEG-ASP) in adults with ALL treated in 3 reference centers in Brazil. Patients and MethodsThis was a cross-sectional retrospective chart-review study encompassing patients aged 15 years and older diagnosed with ALL or ambiguous-lineage leukemia who received at least one dose of PEG-ASP, regardless of the adopted regimen. ResultsA total of 57 patients were included (age range, 15-57 years). Most patients (70%) received 2000 IU/m2 as the initial dose, by intravenous route (72%). The incidence of thromboembolic events was 17.5%, and the main site was cerebral venous sinus (4/10). Thrombosis was more frequent in patients receiving second-line treatment. In obese patients, grade 3 hepatotoxicity and hyperbilirubinemia were more common. Clinical pancreatitis (grade 3 or higher) was found in 2 of 57 cases. PEG-ASP had to be discontinued in 19.3% of exposed patients (11/57). ConclusionBy reviewing the medical charts of adult patients with ALL from 3 reference centers, we found that our incidence of thrombotic and hepatic adverse events is similar to those reported in other trials involving PEG-ASP. Usually these effects should not preclude further use of the drug because most events are manageable in routine clinical practice.

Clevidipine use after first-line treatment failure for perioperative hypertension in neurosurgical patients

Perioperative hypertension is a common occurrence in the neurosurgical population, where 60% to 90% of the patients require treatment for blood pressure (BP) control. Nicardipine and clevidipine have been commonly used in neurocritical settings. This retrospective, observational study assessed the effectivity of the administration of clevidipine after nicardipine treatment failure in neurosurgical patients.We retrospectively reviewed the medical charts of adult patients who were admitted to our neurosurgical department and received clevidipine after nicardipine treatment failure for the control of BP. The primary effectivity outcome was the comparison of the percentage of time spent at targeted SBP goals during nicardipine and clevidipine administration, respectively.A total of 12 adult patients treated with clevidipine after nicardipine treatment failure and were included for data analysis. The median number of events that required dose-titration was 20.5 vs 17 during the administration of nicardipine and clevidipine, respectively (P = .534). The median percentage of time spent at targeted SBP goal was 76.2% during the administration of nicardipine and 93.4% during the administration of clevidipine (P = .123).Our study suggests that clevidipine could be an alternative effective drug with an acceptable benefit/risk ratio in the neurosurgical population that fails to achieve BP control with nicardipine treatment.

The epidemiological and clinical features of odontogenic infective endocarditis.

Antibiotic prophylaxis (AP) of infective endocarditis (IE) in dental practice is a controversial topic. We evaluated the characteristics of the odontogenic IE and assessed the practice and sources of information pertaining to the topic utilized by the Croatian dentists. We conducted a retrospective review of consecutive medical charts of adult patients with IE, admitted to the University Hospital for Infectious Diseases in Zagreb, Croatia, between January 2007 and December 2017. In addition, a cross-sectional, self-reporting questionnaire survey was conducted with participation of 348 Croatian dentists. Of the 811 admissions for suspected IE (40.3% of all Croatian and 92.1% of all Zagreb hospitals), 386 patients were confirmed as definite IE: 68 with odontogenic IE and 318 with IE of other origin. Their first hospital admissions were analyzed. Definite odontogenic IE was defined as a positive echocardiographic result in conjunction with two separate positive blood cultures showing exclusive oral cavity pathogen or Streptococcus viridans associated with current or recent (< 1month) dental, periodontal, or oral cavity infection. The annual number of new odontogenic IE patients appeared constant over time. In 91.2% of the cases, odontogenic IE was not preceded by a dental procedure; poor oral health was found in 51.5% of patients, and 47.1% had no cardiac condition that increases the IE risk. In-hospital mortality was 5.1% with conservative treatment and 4.5% with cardiac surgery and was much lower for odontogenic IE than in non-odontogenic IE (14.6% and 34.4%, respectively). An increasing number of admissions for non-odontogenic IE were observed in parallel with an increasing number of staphylococcal IE. Surveyed dentists (500 invited, 69.6% responded) were aware of the AP recommendations, but were largely reluctant to treat patients at risk. In people with poor oral health, AP should be considered regardless of cardiac risk factors. Improvement of oral health should be the cornerstone of odontogenic IE prevention.

Efficacy and Safety of Nanosomal Docetaxel Lipid Suspension-Based Chemotherapy in Sarcoma: A Multicenter, Retrospective Study.

Objective To evaluate the efficacy and safety of nanosomal docetaxel lipid suspension (NDLS, DoceAqualip) based chemotherapy in patients with sarcoma. Methods In this retrospective, multicenter (6 centers), observational study, we analyzed the medical charts of adult patients of either sex, who were treated with NDLS (75 mg/m2 in 3-weekly cycles) based chemotherapy for the treatment of sarcoma. The efficacy outcomes were overall response rate (ORR: complete response (CR) + partial response (PR)) and disease control rate (DCR: CR + PR + stable disease (SD)) in patients who received NDLS-based chemotherapy in neoadjuvant and metastatic settings. Overall survival (OS) and safety were evaluated for all settings. Results Of 11 patients (neoadjuvant: 1, adjuvant: 3, and metastatic: 7) in this study, majority had leiomyosarcoma (63.6%, 7/11) followed by extraskeletal myxoid chondrosarcoma (EMC), high grade pleomorphic sarcoma of mandible, malignant fibrous histiocytoma of right thigh, and osteosarcoma of femur (9.1% each, 1/11 each). NDLS plus gemcitabine combination was used in 10 patients (90.9%), and NDLS plus cyclophosphamide was used in one patient with EMC (9.1%). Efficacy evaluation was performed for 7 patients (neoadjuvant: 1/1; metastatic: 6/7). Complete response was reported in one patient (soft tissue sarcoma of mandible) treated in neoadjuvant setting. In metastatic setting, ORR was 50% and DCR was 66.7% (CR: 16.7% (1/6), PR: 33.3% (2/6), SD: 16.7% (1/6)). At a median follow-up of 6.5 months (range: 0.06–20.2 months), median OS was not reached in neoadjuvant and adjuvant settings, but it was 15.8 months in metastatic setting. At least 1 AE was reported in 7 (63.6%) patients. Neutropenia, thrombocytopenia, lymphopenia, and anemia were the hematological AEs, whereas nausea, vomiting, and diarrhea were the most common nonhematological AEs. NDLS treatment was well tolerated without any new safety concerns. Conclusion Nanosomal docetaxel lipid suspension-based chemotherapy was efficacious and well tolerated in the treatment of sarcoma. Further prospective trials are needed to confirm the data.

Clinical burden and healthcare resource utilization among patients with chronic hypoparathyroidism, overall and by adequately vs not adequately controlled disease: a multi-country chart review

Aims: To assess the real-world clinical burden and healthcare resource utilization (HRU) among patients with chronic hypoparathyroidism, overall and by adequately controlled (AC) vs not adequately controlled (NAC) disease, informed by guideline-recommended clinical management targets, including biochemistry and symptoms.Materials and methods: In this retrospective online chart review, endocrinologists in the US, Canada, the UK, France, Germany, Italy, and Spain were randomly selected to review the medical charts of adult patients with chronic hypoparathyroidism receiving calcium and activated vitamin D. Patients’ demographics, disease characteristics, symptoms, comorbidities, and hypoparathyroidism-related HRU during the 1 year before the review date were assessed. Clinical burden and HRU were compared between patients with NAC and AC hypoparathyroidism.Results: Of 614 patients with hypoparathyroidism (AC, N = 442; NAC, N = 172), the mean age was 43.6 years, and the majority were female (61.6%), Caucasian (78.8%), and had post-surgical hypoparathyroidism (74.4%). Mean duration of hypoparathyroidism was 46.0 months. Hypoparathyroidism-related symptoms and comorbidities were reported in 59.4% and 46.7% of patients, respectively; 90.7% of patients had ≥1 hypoparathyroidism-related HRU event. More patients with NAC (57.6%) vs AC (42.5%) hypoparathyroidism experienced ≥1 comorbidity including calcium/phosphate imbalances, and brain, cardiovascular, metabolic, and renal disorders (all p < 0.01). More patients with NAC vs AC hypoparathyroidism incurred ≥1 hypoparathyroidism-related hospitalization (27.9% vs 16.3%) and emergency room visits (47.7% vs 38.5%), and patients with NAC vs AC hypoparathyroidism had a higher number of outpatient visits (3.6 vs 2.6; all p < 0.05), in the 1-year observation period.Limitations and conclusions: Limitations of this online chart review include possible under-estimation of disease burden, limited sample size, and the inability to rule out selection bias. Findings indicate that patients with chronic hypoparathyroidism experience substantial symptomatic and comorbid burdens resulting in frequent HRU, suggesting an unmet need, particularly in NAC disease.

Clinical Epidemiology of Septic Arthritis Caused by Burkholderia pseudomallei and Other Bacterial Pathogens in Northeast Thailand.

.Septic arthritis is a medical emergency, and if not treated appropriately, it can be associated with high morbidity and mortality. Melioidosis, a serious infectious disease caused by the Gram-negative bacillus Burkholderia pseudomallei, is highly endemic in South and Southeast Asia and northern Australia. We reviewed the medical charts of adult patients admitted with bacterial septic arthritis at Sunpasitthiprasong Hospital, Ubon Ratchathani, northeast Thailand from January 2012 to December 2014. Bacterial septic arthritis was defined as one or more hot swollen joints with isolation of a pathogenic organism from an affected joint or from blood. A total of 154 patients with septic arthritis were retrospectively evaluated. The most common causes were B. pseudomallei (48%, N = 74), Streptococcus spp. (29%, N = 44), and Staphylococcus aureus (10%, N = 16). Prevalence of diabetes, bacteremia, and pneumonia was higher in B. pseudomallei septic arthritis than in septic arthritis caused by the other bacteria (all P < 0.01). Seventy three percent (54/74) of patients infected with B. pseudomallei and 69% (55/80) of patients with the other bacteria received effective antimicrobials on the first day of admission (P = 0.60), but in-hospital mortality of the former group was considerably higher (34% versus 14%, P = 0.004). In conclusion, B. pseudomallei septic arthritis is common and associated with high mortality in northeast Thailand. Emergence of Streptococcus arthritis is observed. Difficulty in diagnosing melioidosis and identifying B. pseudomallei in areas where health care workers are not familiar with the disease is discussed. In melioidosis-endemic regions, parenteral ceftazidime could be considered as empirical antimicrobial therapy for patients with septic arthritis and underlying diseases.

'What is not written does not exist': the importance of proper documentation of medication use history.

Medications are perceived as health risk factors, because they might cause damage if used improperly. In this context, an adequate assessment of medication use history should be encouraged, especially in transitions of care to avoid unintended medication discrepancies (UMDs). In a case-controlled study, we investigated potential risk factors for UMDs at hospital admission and found that 150 (42%) of the 358 patients evaluated had one or more UMDs. We were surprised to find that there was no record of a patient and/or relative interview on previous use of medication in 117 medical charts of adult patients (44.8%). Similarly, in the medical charts of 52 (53.6%) paediatric patients, there was no record of parents and/or relatives interviews about prior use of medications. One hundred thirty-seven medical charts of adult patients (52.4%) and seventy-two medical charts of paediatric patients (74.2%) had no record about medication allergies and intolerances. In other words, there was a lack of basic documentation regarding the patient's medication use history. As patients move between settings in care, there is insufficient tracking of verbal and written information related to medication changes, which results in a progressive and cumulative loss of information, as evidenced by problems associated with clinical transfers and medication orders. Proper documentation of medication information during transfer is a key step in the procedure; hence, it should be rightly performed. It remains unclear whether interviews, and other investigations about medication use history have been performed but have not been recorded as health-care data. Therefore, it is crucial to the improvement of medication use safety that documentation of all drug-related information-even if not directly relatedto the actual event-become routine practice in health-care organizations, since 'what is not written does not exist'.

Treatment Patterns and Early Outcomes of ALK-Positive Non-Small Cell Lung Cancer Patients Receiving Ceritinib: A Chart Review Study.

This study aimed to provide the first real-world description of the characteristics, treatments, dosing patterns, and early outcomes of patients with ALK-positive non-small cell lung cancer (NSCLC) who received ceritinib in US clinical practice. US oncologists provided data from medical charts of adult patients diagnosed with locally advanced or metastatic ALK-positive NSCLC who received ceritinib following crizotinib. Patient characteristics, treatment patterns, ceritinib dosing, early outcomes, and occurrence of gastrointestinal adverse events (AEs) by dose and instructions on food intake were assessed, and Kaplan-Meier analysis was used to describe clinician-defined progression-free survival (PFS) on ceritinib. Medical charts of 58 ALK-positive NSCLC patients treated with ceritinib were reviewed (median age 63years; 41% male; 21% with prior chemotherapy experience). At ceritinib initiation, 44 patients had multiple distant metastases, most commonly in the liver (60%), bone (53%), and brain (38%). Initial ceritinib dose varied: 71% received 750mg, 19% 600mg, and 10% 450mg. Although median follow-up after ceritinib initiation was short (3.8months), most patients achieved either a complete or partial response (69%) on ceritinib, regardless of metastatic sites present at initiation or initial dose. Median PFS on ceritinib was 12.9months. 17% of patients had a gastrointestinal AE reported during follow-up. The majority of events occurred in patients instructed to fast; no patients instructed to take a lower dose of ceritinib with food reported gastrointestinal AEs. These early findings of ceritinib use in clinical practice suggest that ceritinib is effective at treating crizotinib-experienced ALK-positive NSCLC patients, regardless of metastatic sites or initial dose, and dosing ceritinib with food may lead to fewer gastrointestinal AEs. Future studies with larger sample size and longer follow-up are warranted, including an ongoing randomized trial to assess the gastrointestinal tolerability of ceritinib 450 and 600mg with low-fat meals. Novartis Pharmaceutical Corporation.

Stenotrophomonas maltophilia bloodstream infection: Comparison between community-onset and hospital-acquired infections

Stenotrophomonas maltophilia has been recognized as an important nosocomial pathogen, but few reports have discussed S. maltophilia infection in the community settings. This study aimed to reveal characteristics of patients with community-onset S. maltophilia bloodstream infection (SMBSI), to specify the subgroup of healthcare-associated (HCA) infection in the community-onset group and to compare them with hospital-acquired (HA) SMBSI patients. Medical charts of adult patients with SMBSI presenting to a medical center in southern Taiwan from May 2008 to October 2011 were reviewed and analyzed retrospectively. Among 153 patients, we observed a high percentage (38.6%) of SMBSI to be community onset. Among community-onset SMBSI, 45.8% were community-acquired (CA) and 54.2% were HCA. The crude mortality rates were 11.1%, 18.8%, and 60.6% in the CA, HCA, and HA groups, respectively. Structural/mechanical abnormalities were observed in 32.7% of all cases, and 60% of those were related to malignancy. Independent risk factors for mortality in community-onset SMBSI were liver cirrhosis, liver metastasis, and a high Pitt bacteremia score, whereas structural/mechanical abnormalities and a high Pitt bacteremia score related to increased mortality in HA SMBSI. Community-onset S. maltophilia infection deserves attention. Patients with community-onset SMBSI have reduced disease severity and lower mortality rate when compared to HA SMBSI. Underlying structural/mechanical abnormalities, especially those caused by malignancies, are common in SMBSI cases and should be investigated when bacteremia occurs.

Molecular typing of Mycobacterium tuberculosis isolated from adult patients with tubercular spondylitis

Tuberculosis (TB) is endemic in Taiwan and usually affects the lung, spinal TB accounting for 1-3% of all TB infections. The manifestations of spinal TB are different from those of pulmonary TB. The purpose of this study was to define the epidemiological molecular types of mycobacterial strains causing spinal TB. We retrospectively reviewed the medical charts of adult patients diagnosed with spinal TB from January 1998 to December 2007. Patients with positive culture results and/or pathological findings characteristic of TB were enrolled in this study. Spoligotyping was performed to type the Mycobacterium tuberculosis isolates. A total of 38 patients with spinal TB were identified. Their mean age was 68 years, and their median duration of symptoms was 60 days (range 3-720 days). The lumbar and thoracic spine accounted for 76% of the sites involved. Thirteen specimens (from seven male and six female patients) were available for typing. Spoligotyping of these 13 specimens revealed three Beijing (23%) and 10 non-Beijing types (77%). The non-Beijing types included two EAI2 Manilla (15%), two H3 (15%), two unclassified (15%), and one each of BOVIS1, U, T2, and orphan type. No significant predominant strain was found in this study, and no drug-resistant Beijing strains were identified. TB spondylitis was found to occur in older patients. Spoligotyping results showed that most of the TB spondylitis cases were caused by non-Beijing type Mycobacterium tuberculosis.

Spinal Tuberculosis in Non-HIV-Infected Patients: 10 Year Experience of a Medical Center in Central Taiwan

Tuberculosis (TB) is an endemic disease in Taiwan and it usually affects the lung. Spinal TB accounts for 1-3% of all TB infections. The purpose of this study was to investigate the clinical manifestations, management, outcomes and drug susceptibility of Mycobacterium tuberculosis in non-HIV-infected patients with spinal TB. From January 1998 to December 2007, we retrospectively reviewed the medical charts of adult patients with a diagnosis of spinal TB. Only those with positive culture results and/or characteristic pathologic findings were enrolled. Demographic data, clinical manifestations and susceptibility to anti-TB drugs were reviewed and analyzed. During the study period, 38 patients (23 men, 15 women) with spinal TB were identified and the mean age was 68 years. The median duration of symptoms was 60 days (range, 3-720 days). Amongst the 38 patients, back pain (100%) was the most common clinical symptom, followed by weakness (53%) and numbness (26%). The lumbar spine (15 patients, 39%) was the most commonly involved site, followed by the thoracic spine (14 patients, 37%). Concomitant pulmonary TB was found in 12 patients (32%). Three patients (8%) had concurrent bacterial or fungal infections. Almost all of the patients (35 patients, 92%) were successfully treated with surgery and anti-TB medications. The erythrocyte sedimentation rate was followed up in 16 patients before and after therapy and a significant decline was observed after treatment (p = 0.004). No mortality was related to spinal TB. Insidious clinical course and ambiguous manifestations of spinal TB often delay and hinder the accuracy of diagnosis of spinal TB. In addition to pyogenic osteomyelitis, spinal TB should be included in the differential diagnosis especially in elderly patients with chronic back pain accompanied by elevated erythrocyte sedimentation rate, and those living in the TB endemic area.

Assessment of Individual Characteristics on the Pharmacokinetics of Oral Busulfan in Adults Patients Undergoing Hematopoietic Stem-Cell Transplantation.

Introduction Busulfan is one of the most commonly used drugs in preparative regimens for hematopoietic stem-cell transplantation. Administration of accurate doses of busulfan is critical to limit toxicity while ensuring maximum efficacy. Indeed, busulfan pharmacokinetics exhibit important interpatient variability and its therapeutic interval is narrow.Objective To determine the impact of glutathione-S-transferase (GST) genotype and individual characteristics on the pharmacokinetics of oral busulfan in adult patients.Methods An observational retrospective study was performed. Individual characteristics were obtained from the medical charts of adult patients who received oral busulfan between June 2003 and May 2007. Genotype for the enzyme GST A1 was determined in patients for whom consent was available. Linear regression analysis was used to identify the variables that have significant impact on oral clearance of the first dose of busulfan. Oral and intravenous pharmacokinetics were also compared in patients presenting between November 2006 and May 2007.Results Oral clearance on the first dose of busulfan was available for 104 of the 106 eligible patients. Lean body weight (LBW) was used to determine the dose and was a significant predictor of oral clearance (r = 0,61; r2 = 0,37). No added precision was obtained with the addition of age, bilirubin and hepatic transaminase levels (r = 0,62; r2 = 0,38). GST genotype was determined for 87 patients and an increase in precision is obtained when adding GST genotype to LBW for prediction of oral clearance (r = 0,65; r2 = 0,43). The impact of GST genotype was found to be independent of all other variables considered. The model that includes LBW, GST genotype, age, bilirubin and hepatic transaminase levels provides little further precision (r = 0,67; r2 = 0,45). No significant impact was identified when considering the following variables: gender, creatinine clearance, albumin, lactate deshydrogenase and alkaline phosphatase levels, prior history of chemotherapy and/or radiotherapy, concomitant use of acetaminophen or antifungal drugs. The impact of GST genotype (*A wild-type allele, *B variant allele with reduced activity) on oral clearance was also evaluated. A significant difference in busulfan clearance between individuals with the *A/*A genotype and individuals with the *B/*B genotype was observed (p = 0,003; ANOVA and Bonferroni). In the prospective study, eight patients agreed to receive their second dose of busulfan via the intravenous route. Oral clearance was a good estimation of absolute clearance (Student's t-test for mean difference p = 0,573; r = 0,963). Volume of distribution of busulfan was an excellent predictor of oral clearance for the 8 patients (r = 0,96; r2 = 0,93) and LBW was an adequate predictor of volume of distribution (r = 0,94; r2 = 0,88).Conclusion An increase in precision could be obtained by adjusting the busulfan dose with LBW and GST genotype rather than LBW alone. No other individual patient characteristic was identified that influences significantly the pharmacokinetics of oral busulfan. More than 50% of intersubject variability in busulfan oral pharmacokinetics remains unexplained even after considering all above variables. Estimation of volume of distribution may represent a very innovative and promising avenue to more closely predict busulfan dosage.

Screening for Nephropathy and Antiangiotensin Use Among Diabetic Patients in an Academic Community Medical Center

The American Diabetes Association recommends routine screening for albuminuria to detect early nephropathy in all patients with diabetes mellitus. If nephropathy is identified, treatment with an antiangiotensin agent decreases progression and improves renal outcomes. Concordance with guidelines for nephropathy screening and antiangiotensin therapy among diabetic patients in a primary care setting of an academic community medical center was evaluated. Medical charts of adult patients with diabetes mellitus from February 2000 through January 2003 were retrospectively reviewed. In part 1 of the study, whether patients were screened for nephropathy at least once was recorded. In part 2 of the study, antiangiotensin prescribing was assessed in all patients and in subgroups stratified by screening. In both parts of the study, patient characteristics and comorbidities were assessed using multivariate analysis to determine their impact on the odds that a patient was screened and that antiangiotensin therapy was prescribed. Among the 329 patients included, 182 patients (55.3%) were screened for nephropathy. Patients who were screened were younger (OR=0.83 for 10-year increase, 95% CI: 0.69-0.99), less likely to have congestive heart failure (OR=0.42, 95% CI: 0.20-0.90), and more likely to be cared for by a resident physician directly supervised by an attending physician (OR=3.03; 95% CI: 1.82-5.03). A total of 215 patients (65.3%) were prescribed antiangiotensin therapy. Hypertension was a predictor of antiangiotensin therapy among all patients who were screened (OR=10.34, 95% CI: 4.45-24.01), those who were screened and negative (OR=15.46, 95% CI: 5.56-42.98), and those who were not screened (OR=10.79, 95% CI: 4.39-26.52). Among patients screened for nephropathy, coronary artery disease (OR=3.01, 95% CI: 1.05-8.63), and the presence of proteinuria (OR=4.26, 95% CI: 1.61-11.24) were predictors of antiangiotensin use. This study found that the likelihood of screening for nephropathy among diabetic patients was inversely associated with a diagnosis of congestive heart failure and increasing age. Conversely, care by a resident physician directly supervised by an attending physician increased the odds that patients would be screened. A diagnosis of hypertension and the presence of albuminuria were each associated with increased use of an antiangiotensin agent.

Access to antiretroviral therapy among HIV/AIDS patients in khon kaen province, Thailand

This study attempted to identify the factors associated with the access to antiretroviral therapy (ARV) among HIV/AIDS patients in Khon Kaen Province, Thailand. We collected medical and sociodemographic data from the medical charts of adult patients living in the province who received medical services at two public hospitals in the province. The study period was from December 1 2001 to February 28 2002. Total 593 outpatients were included in the analysis. One hundred and forty-six patients (24.6%) received ARV. A logistic regression analysis was conducted to identify the factors associated with the use of ARV. Patients who were covered by the Civil Servant Medical Benefit Scheme were significantly more likely to receive ARV than those who were covered by the Universal Coverage Scheme (UC), a publicly-funded medical insurance (OR=12.43; 95% CI=6.03–25.62). The results of this study indicated that there were inequalities in access to and use of ARV among HIV/AIDS patients by health insurance status. The current government announced that they would include ARV in the benefits package of UC. It would be important to monitor how this policy will improve the access to ARV among HIV/AIDS patients.