The burden of nonalcoholic steatohepatitis (NASH) in the United States.

BACKGROUND: There is limited data on the comparative economic and humanistic burden of non-alcoholic steatohepatitis (NASH) in the United States. The objective was to examine the burden of disease comparing NASH to a representative sample of the general population and separately to a type 2 diabetes mellitus (T2DM) cohort by assessing health-related quality of life (HRQoL) measures, healthcare resource use (HRU) and work productivity and activity impairment (WPAI). METHODS: Data came from the 2016 National Health and Wellness Survey, a nationally representative patient-reported outcomes survey conducted in the United States. Respondents with physician-diagnosed NASH, physician-diagnosed T2DM, and respondents from the general population were compared. Humanistic burden was examined with mental (MCS) and physical (PCS) component summary scores from the Short-Form (SF)-36v2, concomitant diagnosis of anxiety, depression, and sleep difficulties. Economic burden was analysed based on healthcare professional (HCP) and emergency room (ER) visits, hospitalizations in the past six months; absenteeism, presenteeism, overall work impairment, and activity impairment scores on WPAI questionnaire. Bivariate and multivariable analysis were conducted for each outcome and matched comparative group. RESULTS: After adjusting for baseline demographics and characteristics, NASH (N = 136) compared to the matched general population cohort (N = 544), reported significantly lower (worse) mental (MCS 43.19 vs. 46.22, p = 0.010) and physical (PCS 42.04 vs. 47.10, p < 0.001) status, higher % with anxiety (37.5% vs 25.5%, p = 0.006) and depression (43.4% vs 30.1%, p = 0.004), more HCP visits (8.43 vs. 5.17), ER visits (0.73 vs. 0.38), and hospitalizations (0.43 vs. 0.2) all p's < 0.05, and higher WPAI scores (e.g. overall work impairment 39.64% vs. 26.19%, p = 0.011). NASH cohort did not differ from matched T2DM cohort (N = 272) on mental or work-related WPAI scores, but had significantly worse physical status (PCS 40.52 vs. 44.58, p = 0.001), higher % with anxiety (39.9% vs 27.8%, p = 0.043), more HCP visits (8.63 vs. 5.68, p = 0.003) and greater activity impairment (47.14% vs. 36.07%, p = 0.010). CONCLUSION: This real-world study suggests that burden of disease is higher for all outcomes assessed among NASH compared to matched general controls. When comparing to T2DM, NASH cohort has comparable mental and work-related impairment but worse physical status, daily activities impairment and more HRU.

Real-World Burden of Nonalcoholic Steatohepatitis.

BACKGROUND & AIMS: Nonalcoholic steatohepatitis (NASH) is associated with an increase in healthcare resource use and poor health-related quality of life (HRQoL). We assessed the humanistic and economic burden of NASH, disease management, and patient journey. METHODS: We performed a cross-sectional analysis of data, collected from July through November 2017, from the Growth from Knowledge Disease Atlas Real-World Evidence program, reported by physicians in United States, France, and Germany. We extracted demographic and medical data from medical records. Some patients voluntarily completed a survey that provided information on disease history, treatment satisfaction, and patient-reported outcomes. RESULTS: We analyzed data from 1216 patients (mean age, 54.9±12.3 years; 57.5% male; mean body mass index, 31.7±6.9); 64.6% had biopsy-confirmed NASH and comorbidities were recorded for 41.3%. Treatments included lifestyle modification (64.6%) or use of statins (25.0%), vitamin E (23.5%), or metformin (20.2%). Patients with biopsy-confirmed NASH reported more physician (4.5 vs 3.7) and outpatient visits (1.8 vs1.4) than patients with suspected NASH not confirmed by biopsy. Among the 299 patients who completed the survey, 47.8% reported various symptoms associated to their NASH. Symptomatic patients reported significantly lower HRQoL than patients without symptoms. CONCLUSIONS: In an analysis of data from 3 countries, we found NASH to be associated with regular use of medical resources; patients with symptoms of NASH had reduced HRQoL. The burden of NASH appears to be underestimated. Studies are needed to determine the burden of NASH by fibrosis stage and disease severity.

Systemic treatment of hormone receptor positive, human epidermal growth factor 2 negative metastatic breast cancer: retrospective analysis from Leeds Cancer Centre.

BACKGROUND: Study aimed to characterise treatment and outcomes for patients with hormone receptor positive (HR+), human epidermal growth factor 2 negative (HER2-) metastatic breast cancer (MBC) within a large regional cancer centre, as a benchmark for evaluating real-world impact of novel therapies. METHODS: Retrospective longitudinal cohort, using electronic patient records of adult females with a first diagnosis of HR+/HER2- MBC January 2012-March 2018. RESULTS: One hundred ninety-six women were identified with HR+/HER2- MBC. Median age was 67 years, 85.2% were post-menopausal and median time between primary diagnosis and metastasis was 5.4 years. Most (75.1%) patients received endocrine therapy as first line systemic treatment (1st LoT); use of 1st LoT chemotherapy halved between 2012 and 2017. Patients receiving 1st LoT chemotherapy were younger and more likely to have visceral metastasis (p < 0.01). Median OS was 29.5 months and significantly greater for patients with exclusively non-visceral metastasis (p < 0.01). The adjusted hazard ratio for death of patients with visceral (or CNS) metastasis was 1.91 relative to those with exclusively non-visceral metastasis. CONCLUSIONS: Diverse endocrine therapies predominate as 1st LoT for patients with HR+/HER2- MBC, chemotherapy being associated with more aggressive disease in younger patients, emphasising the importance of using effective and tolerable therapies early.

Identification and mapping of worldwide sources of generic real-world data.

PURPOSE: The demand for real-world data as supportive evidence to traditional clinical studies has increased in the past few years. The present study aimed to identify worldwide generic sources of real-world data and to assess completeness and suitability of selected real-world evidence (RWE) data sources to conduct prespecified research. METHODS: A systematic literature review was conducted to identify generic (non-disease specific) sources of real-world data in Medline and Embase from January 1, 2010 to September 8, 2015. Data sources used in observational studies were identified and summarized based on their geographical distribution and the type of data. In the next step, the selected data sources were critically evaluated for their completeness. RESULTS: A total of 10,069 identified publications were screened, leading to 2635 unique data sources across 102 countries. Europe had the maximum number of data sources (n = 1163) followed by United States (n = 578), and Asia, Middle East, and African Countries (n = 374). The most common type of identified data sources across all countries was structured data sources, ie, administrative databases and registries. Of the identified data sources, 300 were selected for further investigation. From the selected databases, ~50% had confirmed information on over 60% of the investigated variables, ~61% were suitable for epidemiological research, and 60% had possibility of linkage. CONCLUSIONS: The present study applied a systematic literature review approach and identified available generic sources of real-world data worldwide, in addition to the United States and Europe, which are suitable for conducting pre-defined researches and support future RWE studies.

Thoracic cancer surgeries.

In 2005, Cancer Care Ontario (CCO) released Thoracic Surgical Oncology Standards. These standards were aimed at providing the best level of care for those undergoing thoracic surgery and encompass surgeon training, hospital ancillary services and minimum volume thresholds for surgeries of the lung and esophagus. The objective of the current study was to explore variations in thoracic cancer surgical volumes at the hospital level across Canada. Using data from the Discharge Abstract Database for 2007-2008, the cohort included patients admitted to hospital with a most responsible diagnosis of cancer and who had a lung or esophageal surgery. To determine the volume of surgeries performed per facility, we grouped patients according to the hospital facility performing the surgery. In Canada (excluding Quebec and Prince Edward Island), there were a total 4,509 lung and 587 esophageal cancer procedures performed in 94 hospitals in 2007-2008. For both types of surgeries, Ontario hospitals performed approximately half of the procedures. Overall, 12 hospitals performed at or over the volume of surgeries for lung cancer as indentified by the CCO standards, while 10 did so for esophageal cancer. Nine hospitals performed both lung and esophageal cancer surgeries at or over the suggested volumes. Higher volumes of lung and esophageal cancer-related surgeries have been associated with improved patient outcomes. Here we present a snapshot of the distribution of cancer-related lung and esophageal surgeries across Canada (excluding Quebec and Prince Edward Island).

Falls among top reasons for transfers from continuing care to acute care hospitals in Canada.

There are limited data on the quality and safety of care for residents in continuing care settings. An analysis of the main reasons why residents, 75 and older, of continuing care facilities are transferred to acute care demonstrates that two of the top three reasons for transfers result from potentially avoidable events.

The burden of non-alcoholic steatohepatitis (NASH) among patients from Europe: A real-world patient-reported outcomes study.

Data on the economic and humanistic burden of non-alcoholic steatohepatitis (NASH) are scarce. This study assessed the comparative burden of NASH, relative to a representative sample from the general population and a type 2 diabetes mellitus (T2DM) cohort, in terms of health-related quality of life, work productivity and activity impairment (WPAI), and healthcare resource use. METHODS: Data across 5 European countries came from the 2016 National Health and Wellness Survey, a nationally representative patient-reported outcomes survey. Outcomes included mental (MCS) and physical (PCS) component scores from the Short-Form (SF)-36v2, WPAI scores, self-reported physician diagnosis of sleep difficulties, anxiety, and depression, and healthcare resource use: healthcare professional visits, hospital visits, and emergency room visits in the previous 6 months. Bivariate and multivariable analyses were conducted for each outcome and comparative group. RESULTS: After adjusting for matching criteria and covariates, patients with NASH (n = 184) reported significantly worse health-related quality of life, worse WPAI scores, and more healthcare resource use than the general population (n = 736) (MCS 39.22 vs. 45.16, PCS 42.84 vs. 47.76; overall work impairment 49.15% vs. 30.77%, healthcare professional visits 10.73 vs. 6.01, emergency room visits 0.57 vs. 0.22, hospitalizations 0.47 vs. 0.17, p ≪0.05 for all). Patients with NASH did not differ from patients with T2DM (n = 368) on PCS and WPAI scores, suggesting a similar impairment on work and daily activities, but did report significantly worse mental status (MCS 39.64 vs. 43.64, p ≪0.05) and more healthcare resource use than those with T2DM (healthcare professional visits 10.85 vs. 7.86, emergency room visits 0.65 vs. 0.23, hospitalizations 0.39 vs. 0.19, p ≪0.05 for all). CONCLUSIONS: These findings suggest that the burden of NASH may be underestimated, highlighting the unmet needs of patients with NASH. LAY SUMMARY: These findings show that patients with non-alcoholic steatohepatitis (NASH) experience a significant burden of illness, in terms of health-related quality of life, work productivity and activity impairment, and healthcare resource use. As there is currently no approved treatment for NASH, these findings highlight the unmet medical need of patients with NASH.

CT, MRI and ultrasound scanning rates: evaluation of cancer diagnosis, staging and surveillance in Ontario.

OBJECTIVE: To examine practice patterns and rates of computed tomography (CT), magnetic resonance imaging (MRI), and abdominal ultrasound (AUS) during staging, treatment and surveillance for cancer patients. METHODS: Using Ontario Health Insurance Plan billing data linked to the Ontario Cancer Registry, we determined rates of CT, MRI, and AUS by body site for breast, colorectal, lung, lymphoma, and prostate cancer, from 1998 to 2002. Rates of scans were additionally examined by region of patient residence and time from cancer diagnosis. RESULTS: The frequency of imaging increased in nearly all scans and tumors over the study period. Rates of peri-diagnosis scans varied substantially by region, ranging from 1.7-fold variation (CT for lung cancer) to 50-fold variation (MRI for breast cancer). For breast cancer, there is possible over-utilization of CT, but overall rates of scanning appear reasonable for the other four cancers. CONCLUSIONS: Considerable regional variation in imaging rates suggests utilization guidelines should be developed or knowledge transfer initiatives are needed to improve compliance to existing guidelines. In breast cancer, there appears to be over-utilization of imaging. Further studies are necessary to determine utilization for each stage, the reason scans were obtained, and the impact of scans on patient outcomes.

Childhood asthma surveillance using administrative data: consistency between medical billing and hospital discharge diagnoses.

BACKGROUND: The absence of ongoing surveillance for childhood asthma in Montreal, Quebec, prompted the present investigation to assess the validity and practicality of administrative databases as a foundation for surveillance. OBJECTIVE: To explore the consistency between cases of asthma identified through physician billings compared with hospital discharge summaries. METHODS: Rates of service use for asthma in 1998 among Montreal children aged one, four and eight years were estimated. Correspondence between the two databases (physician billing claims versus medical billing claims) were explored during three different time periods: the first day of hospitalization, during the entire hospital stay, and during the hospital stay plus a one-day margin before admission and after discharge ('hospital stay +/- 1 day'). RESULTS: During 1998, 7.6% of Montreal children consulted a physician for asthma at least once and 0.6% were hospitalized with a principal diagnosis of asthma. There were no contemporaneous physician billings for asthma 'in hospital' during hospital stay +/- 1 day for 22% of hospitalizations in which asthma was the primary diagnosis recorded at discharge. Conversely, among children with a physician billing for asthma 'in hospital', 66% were found to have a contemporaneous in-hospital record of a stay for 'asthma'. CONCLUSIONS: Both databases of hospital and medical billing claims are useful for estimating rates of hospitalization for asthma in children. The potential for diagnostic imprecision is of concern, especially if capturing the exact number of uses is more important than establishing patterns of use.

Exploring spatial patterns of sudden cardiac arrests in the city of Toronto using Poisson kriging and Hot Spot analyses.

INTRODUCTION: Our study looked at out-of-hospital sudden cardiac arrest events in the City of Toronto. These are relatively rare events, yet present a serious global clinical and public health problem. We report on the application of spatial methods and tools that, although relatively well known to geographers and natural resource scientists, need to become better known and used more frequently by health care researchers. MATERIALS AND METHODS: Our data came from the population-based Rescu Epistry cardiac arrest database. We limited it to the residents of the City of Toronto who experienced sudden arrest in 2010. The data was aggregated at the Dissemination Area level, and population rates were calculated. Poisson kriging was carried out on one year of data using three different spatial weights. Kriging estimates were then compared in Hot Spot analyses. RESULTS: Spatial analysis revealed that Poisson kriging can yield reliable rates using limited data of high quality. We observed the highest rates of sudden arrests in the north and central parts of Etobicoke, western parts of North York as well as the central and southwestern parts of Scarborough while the lowest rates were found in north and eastern parts of Scarborough, downtown Toronto, and East York as well as east central parts of North York. Influence of spatial neighbours on the results did not extend past two rings of adjacent units. CONCLUSIONS: Poisson kriging has the potential to be applied to a wide range of healthcare research, particularly on rare events. This approach can be successfully combined with other spatial methods. More applied research, is needed to establish a wider acceptance for this method, especially among healthcare researchers and epidemiologists.

Contaminant exposure among women of childbearing age who eat St. Lawrence River sport fish.

Little information is available concerning the level of consumption and degree of contaminant exposure for North American women of childbearing age who eat sport fish. The authors reanalyzed a 1995-1996 study of Montreal-area (Canada) sport fishers. The authors focused on women sport fishers of childbearing age and male sport fishers who had spouses of childbearing age. The primary research involved an on-site questionnaire about fish consumption, with follow-up assessment of sport fishers estimated to have either the highest or lowest levels of fish-based contaminant exposure. Among the 1,654 interviewees were 100 women less than 45 yr of age who had eaten sport fish for an average of 11 yr; 45% ate fish less than once a month. From the follow-up subsample of high- and low-level consumers, the authors identified 17 women less than 45 yr of age and 25 males whose spouses who were less than 45 yr of age and who consumed similar quantities of sport fish. Among this group of 42, the high-exposure women differed from the low-exposure women with respect to their yearly consumption of freshwater fish, blood mercury levels (median = 6.4 vs. 1.4 microgram/l), and plasma polychlorinated biphenyl congener 99 (median = 10.5 vs. 5.9 microgram/kg plasma lipids). Few Montreal-area women of childbearing age consume local sport fish frequently or for extended periods. However, among the small proportion that consumes sport fish frequently or for extended periods, blood mercury concentrations approach levels of concern for fetal protection.

Evaluation of CT and MRI scanning among cancer patients in Ontario.

BACKGROUND: Computed tomography (CT) and magnetic resonance imaging (MRI) utilization in Ontario increased drastically since the early 1990s. The effect of an increased number of cancer diagnoses, and an increase in indications for scans has not been assessed. This study was conducted to determine trends in utilization of CT and MRI in cancer patients in Ontario over a period of 9 years. METHODS: Using Ontario Health Insurance Plan billing data linked to the Ontario Cancer Registry, rates of CT and MRI were analyzed by region, year, scan type and socioeconomic status. RESULTS: CT in cancer patients increased 2.3-fold and accounted for approximately 24% of these scans. MRI in cancer patients increased by 4.2-fold and accounted for approximately 10% of these scans. Imaging rates for cancer patients increased more gradually than that of the general population. Substantial variation in the rate of both scans by region of patient residence existed. Even greater variation by the location of the scanner was demonstrated, indicating that many cancer patients traveled outside their region for imaging. There was little evidence of variation in scanning rates by socioeconomic status. CONCLUSION: A minority of CT and MRI performed in Ontario are for cancer care. Regional variation in imaging rates suggest that utilization guidelines be developed or knowledge transfer initiatives improve compliance to existing guidelines are needed. A significant number of cancer patients travel outside their region for diagnostic imaging; this should influence decisions about the location of new scanners.

Indications for and results of outpatient computed tomography and magnetic resonance imaging in Ontario.

OBJECTIVE: Population rates of computed tomography (CT) and magnetic resonance imaging (MRI) continue to increase markedly. However, little is known about the indications for and results of these imaging tests. METHODS: A cross-sectional chart-abstraction study was used to determine the indications for and results of outpatient CT and MRI scans performed on or after January 1, 2005, at randomly selected Ontario hospitals. RESULTS: We studied 11,824 CT and 11,867 MRI scans. Cancer-related indications accounted for over 50% of CT scans of the abdomen-pelvis and chest. Headache was the most frequent indication for CT of the brain. More than one-half of MRI scans of the extremities were for knee pain or suspected meniscal tear. Back pain and radiculopathy were the most frequent indications for MRI of the spine. There was considerable variation between institutions in ordering patterns, with as much as a 70-fold difference between hospitals in the frequency of scans ordered for a specific indication. Less than 2% of CT scans of the brain for headache found abnormalities that could explain the headache, while over 90% of MRI scans of the spine for back pain were abnormal, although the clinical importance of the abnormalities was unclear. CONCLUSIONS: These data are a starting point for a discussion about appropriateness. Further information will be obtained by examining individual indications more closely, and linking these data to administrative databases to evaluate the impact of these imaging tests on clinical practice.

Waiting times for radiation therapy in Ontario.

BACKGROUND: The mass media and clinical journals have reported lengthy waiting times after surgery before initiation of radiation therapy (RT) for cancer across Canada. We aimed to describe the length of time between the last date of surgery or biopsy or chemotherapy and first date of RT. METHODS: This is a population-based study measuring waiting times for RT in Ontario among all patients with potentially curable cancer of the cervix, tonsil and larynx and a random sample of women who had had breast cancer resection, whose first date of RT fell between Sept. 1, 2001, and Aug. 31, 2002. Abstraction of original health care records provided each patient's demographics, cancer stage and cancer treatment (last surgery, consultation, simulation, first RT). Last dates of chemotherapy before RT were obtained from abstraction or from Ontario Health Insurance Plan (OHIP) files, and last dates of surgery before RT were compared with dates in the Canadian Institute for Health Information (CIHI) Discharge Abstract Database. RESULTS: Waiting times between the last date of surgery or chemotherapy and the first date of RT varied significantly among the health regions of Ontario. Increasing age, but not the presence of comorbidity, was associated with longer waiting times. Women who did not receive postoperative chemotherapy before RT for breast cancer waited significantly longer than all others. CONCLUSION: Measurement of waiting times for cancer RT must discount time during which adjuvant intravenous chemotherapy is administered after surgery and before RT. There appears to be a formal or informal process by which those at highest risk begin RT most rapidly.