Building on existing tools to improve chronic disease prevention and screening in public health: a cluster randomized trial.

BACKGROUND: The BETTER (Building on Existing Tools to Improve Chronic Disease Prevention and Screening in Primary Care) intervention was designed to integrate the approach to chronic disease prevention and screening in primary care and demonstrated effective in a previous randomized trial. METHODS: We tested the effectiveness of the BETTER HEALTH intervention, a public health adaptation of BETTER, at improving participation in chronic disease prevention and screening actions for residents of low-income neighbourhoods in a cluster randomized trial, with ten low-income neighbourhoods in Durham Region Ontario randomized to immediate intervention vs. wait-list. The unit of analysis was the individual, and eligible participants were adults age 40-64 years residing in the neighbourhoods. Public health nurses trained as "prevention practitioners" held one prevention-focused visit with each participant. They provided participants with a tailored prevention prescription and supported them to set health-related goals. The primary outcome was a composite index: the number of evidence-based actions achieved at six months as a proportion of those for which participants were eligible at baseline. RESULTS: Of 126 participants (60 in immediate arm; 66 in wait-list arm), 125 were included in analyses (1 participant withdrew consent). In both arms, participants were eligible for a mean of 8.6 actions at baseline. At follow-up, participants in the immediate intervention arm met 64.5% of actions for which they were eligible versus 42.1% in the wait-list arm (rate ratio 1.53 [95% confidence interval 1.22-1.84]). CONCLUSION: Public health nurses using the BETTER HEALTH intervention led to a higher proportion of identified evidence-based prevention and screening actions achieved at six months for people living with socioeconomic disadvantage. TRIAL REGISTRATION: NCT03052959 , registered February 10, 2017.

The impact of the COVID-19 pandemic on the Ontario Cervical Screening Program, colposcopy and treatment services in Ontario, Canada: a population-based study.

OBJECTIVE: To describe the immediate impact of the COVID-19 pandemic on cervical screening, colposcopy and treatment volumes in Ontario, Canada. DESIGN: Population-based retrospective observational study. SETTING: Ontario, Canada. POPULATION: People with a cervix age of 21-69 years who completed at least one cervical screening cytology test, colposcopy or treatment procedure for cervical dysplasia between January 2019 and August 2020. METHODS: Administrative databases were used to compare cervical screening cytology, colposcopy and treatment procedure volumes before (historical comparator) and during the first 6 months of the COVID-19 pandemic (March-August 2020). MAIN OUTCOME MEASURES: Changes in cervical screening cytology, colposcopy and treatment volumes; individuals with high-grade cytology awaiting colposcopy. RESULTS: During the first 6 months of the COVID-19 pandemic, the monthly average number of cervical screening cytology tests, colposcopies and treatments decreased by 63.8% (range: -92.3 to -41.0%), 39.7% (range: -75.1 to -14.3%) and 31.1% (range: -43.5 to -23.6%), respectively, when compared with the corresponding months in 2019. Between March and August 2020, on average 292 (-51.0%) fewer high-grade cytological abnormalities were detected through screening each month. As of August 2020, 1159 (29.2%) individuals with high-grade screening cytology were awaiting follow-up colposcopy. CONCLUSIONS: The COVID-19 pandemic has had a substantial impact on key cervical screening and follow-up services in Ontario. As the pandemic continues, ongoing monitoring of service utilisation to inform system response and recovery is required. Future efforts to understand the impact of COVID-19-related disruptions on cervical cancer outcomes will be needed. TWEETABLE ABSTRACT: COVID-19 has had a substantial impact on cervical screening and follow-up services in Ontario, Canada.

A centrally generated primary care physician audit report does not improve colonoscopy uptake after a positive result on a fecal occult blood test in Ontario's ColonCancerCheck program.

BACKGROUND: Timely follow-up of fecal occult blood screening with colonoscopy is essential for achieving colorectal cancer mortality reduction. In the present study, we evaluated the effectiveness of centrally generated, physician-targeted audit and feedback to improve colonoscopy uptake after a positive fecal occult blood test (fobt) result within Ontario's population-wide ColonCancerCheck Program. METHODS: This prospective cohort study used data sets from Ontario's ColonCancerCheck Program (2008-2011) that were linked to provincial administrative health databases. Cox proportional hazards regression was used to estimate the effect of centralized, physician-targeted audit and feedback on colonoscopy uptake in an Ontario-wide fobt-positive cohort. RESULTS: A mailed physician audit and feedback report identifying individuals outstanding for colonoscopy for 3 or more months after a positive fobt result did not increase the likelihood of colonoscopy uptake (hazard ratio: 0.95; 95% confidence interval: 0.79 to 1.13). Duration of positive fobt status was strongly inversely associated with the hazard of follow-up colonoscopy (p for linear trend: <0.001). CONCLUSIONS: In a large population-wide setting, centralized tracking in the form of physician-targeted mailed audit and feedback reports does not improve colonoscopy uptake for screening participants with a positive fobt result outstanding for 3 or more months. Mailed physician-targeted screening audit and feedback reports alone are unlikely to improve compliance with follow-up colonoscopy in Ontario. Other interventions such as physician audits or automatic referrals, demonstrated to be effective in other jurisdictions, might be warranted.

The Quality of Colonoscopy Reporting in Usual Practice: Are Endoscopists Reporting Key Data Elements?

Background. High quality reporting of endoscopic procedures is critical to the implementation of colonoscopy quality assurance programs. Objective. The aim of our research was to (1) determine the quality of colonoscopy (CS) reporting in "usual practice," (2) identify factors associated with good quality reporting, and (3) compare CS reporting in open-access and non-open-access procedures. Methods. 557 CS reports were randomly selected and assigned a score based on the number of mandatory data elements included in the report. Reports documenting greater than 70% of the mandatory data elements were considered to be of good quality. Physician and procedure factors associated with good quality CS reporting were identified. Results. Variables that were consistently well documented included date of the procedure (99.6%), procedure indication (88.9%), a description of the most proximal anatomical segment reached (98.6%), and documentation of polyp location (97.8%). Approximately 79.4% of the reports were considered to be of good quality. Gastroenterology specialty, lower annual CS volume, and fewer years in practice were associated with good quality reporting. Discussion. CS reporting in usual practice in Ontario lacks quality in several areas. Almost 1 in 5 reports was of poor quality in our study. Conclusions. Targeted interventions and/or use of mandatory fields in synoptic reports should be considered to improve CS reporting.

Training non-physicians to do endoscopy: Feasibility, effectiveness and cost-effectiveness.

Colorectal cancer (CRC) is one of the most common cancers in women and men worldwide. Training non-physicians including nurses, nurse practitioners, and physician assistants to perform endoscopy can provide the opportunity to expand access to CRC screening as demand for endoscopic procedures continues to grow. A formal program, incorporating didactic instruction and hands-on practice in addition to oversight, is required to train non-physicians to perform endoscopy as safely and effectively as physicians. Additionally, the context in which the non-physician endoscopy program is organized will dictate key program characteristics including remuneration, participant recruitment and professional and legal considerations. This review explores the evidence in support of non-physician based endoscopy, potential challenges in implementing non-physician endoscopy and requirements for a high-quality program to support training and implementation.

Definition and taxonomy of interval colorectal cancers: a proposal for standardising nomenclature.

OBJECTIVE: Interval colorectal cancers (interval CRCs), that is, cancers occurring after a negative screening test or examination, are an important indicator of the quality and effectiveness of CRC screening and surveillance. In order to compare incidence rates of interval CRCs across screening programmes, a standardised definition is required. Our goal was to develop an internationally applicable definition and taxonomy for reporting on interval CRCs. DESIGN: Using a modified Delphi process to achieve consensus, the Expert Working Group on interval CRC of the Colorectal Cancer Screening Committee of the World Endoscopy Organization developed a nomenclature for defining and characterising interval CRCs. RESULTS: We define an interval CRC as a "colorectal cancer diagnosed after a screening or surveillance exam in which no cancer is detected, and before the date of the next recommended exam". Guidelines and principles for describing and reporting on interval CRCs are provided, and clinical scenarios to demonstrate the practical application of the nomenclature are presented. CONCLUSIONS: The Working Group on interval CRC of the World Endoscopy Organization endorses adoption of this standardised nomenclature. A standardised nomenclature will facilitate benchmarking and comparison of interval CRC rates across programmes and regions.

An updated Asia Pacific Consensus Recommendations on colorectal cancer screening.

OBJECTIVE: Since the publication of the first Asia Pacific Consensus on Colorectal Cancer (CRC) in 2008, there are substantial advancements in the science and experience of implementing CRC screening. The Asia Pacific Working Group aimed to provide an updated set of consensus recommendations. DESIGN: Members from 14 Asian regions gathered to seek consensus using other national and international guidelines, and recent relevant literature published from 2008 to 2013. A modified Delphi process was adopted to develop the statements. RESULTS: Age range for CRC screening is defined as 50-75 years. Advancing age, male, family history of CRC, smoking and obesity are confirmed risk factors for CRC and advanced neoplasia. A risk-stratified scoring system is recommended for selecting high-risk patients for colonoscopy. Quantitative faecal immunochemical test (FIT) instead of guaiac-based faecal occult blood test (gFOBT) is preferred for average-risk subjects. Ancillary methods in colonoscopy, with the exception of chromoendoscopy, have not proven to be superior to high-definition white light endoscopy in identifying adenoma. Quality of colonoscopy should be upheld and quality assurance programme should be in place to audit every aspects of CRC screening. Serrated adenoma is recognised as a risk for interval cancer. There is no consensus on the recruitment of trained endoscopy nurses for CRC screening. CONCLUSIONS: Based on recent data on CRC screening, an updated list of recommendations on CRC screening is prepared. These consensus statements will further enhance the implementation of CRC screening in the Asia Pacific region.

Cancer diagnostic assessment programs: standards for the organization of care in Ontario.

BACKGROUND: Improving access to better, more efficient, and rapid cancer diagnosis is a necessary component of a high-quality cancer system. How diagnostic services ought to be organized, structured, and evaluated is less understood and studied. Our objective was to address this gap. METHODS: As a quality initiative of Cancer Care Ontario's Program in Evidence-Based Care, the Diagnostic Assessment Standards Panel, with representation from clinical oncology experts, institutional and clinical administrative leaders, health service researchers, and methodologists, conducted a systematic review and a targeted environmental scan of the unpublished literature. Standards were developed based on expert consensus opinion informed by the identified evidence. Through external review, clinicians and administrators across Ontario were given the opportunity to provide feedback. RESULTS: The body of evidence consists of thirty-five published studies and fifteen unpublished guidance documents. The evidence and consensus opinion consistently favoured an organized, centralized system with multidisciplinary team membership as the optimal approach for the delivery of diagnostic cancer assessment services. Independent external stakeholders agreed (with higher mean values, maximum 5, indicating stronger agreement) that DAP standards are needed (mean: 4.6), that standards should be formally approved (mean: 4.3), and importantly, that standards reflect an effective approach that will lead to quality improvements in the cancer system (mean: 4.5) and in patient care (mean: 4.3). INTERPRETATION: Based on the best available evidence, standards for the organization of DAPS are offered. There is clear need to integrate formal and comprehensive evaluation strategies with the implementation of the standards to advance this field.

Increasing incidence of paediatric inflammatory bowel disease in Ontario, Canada: evidence from health administrative data.

OBJECTIVE: Health administrative databases can be used to track chronic diseases. The aim of this study was to validate a case ascertainment definition of paediatric-onset inflammatory bowel disease (IBD) using administrative data and describe its epidemiology in Ontario, Canada. METHODS: A population-based clinical database of patients with IBD aged <15 years was used to define cases, and patient information was linked to health administrative data to compare the accuracy of various patterns of healthcare use. The most accurate algorithm was validated with chart data of children aged <18 years from 12 medical practices. Administrative data from the period 1991-2008 were used to describe the incidence and prevalence of IBD in Ontario children. Changes in incidence were tested using Poisson regression. RESULTS: Accurate identification of children with IBD required four physician contacts or two hospitalisations (with International Classification of Disease (ICD) codes for IBD) within 3 years if they underwent colonoscopy and seven contacts or three hospitalisations within 3 years in those without colonoscopy (children <12 years old, sensitivity 90.5%, specificity >99.9%; children <15 years old, sensitivity 89.6%, specificity >99.9%; children <18 years old, sensitivity 91.1%, specificity 99.5%). Age- and sex-standardised prevalence per 100 000 population of paediatric IBD has increased from 42.1 (in 1994) to 56.3 (in 2005). Incidence per 100 000 has increased from 9.5 (in 1994) to 11.4 (in 2005). Statistically significant increases in incidence were noted in 0-4 year olds (5.0%/year, p = 0.03) and 5-9 year olds (7.6%/year, p<0.0001), but not in 10-14 or 15-17 year olds. CONCLUSION: Ontario has one of the highest rates of childhood-onset IBD in the world, and there is an accelerated increase in incidence in younger children.

Prevalence of screening in patients newly diagnosed with colorectal cancer in Ontario.

OBJECTIVES: The primary objective was to determine the proportion of individuals with a new diagnosis of colorectal cancer (CRC) in Ontario in whom the cancer was screen detected. The secondary objectives were to determine the cancer stage at diagnosis and the indications for the procedure in patients who received their first colonoscopy. PATIENTS AND METHODS: Individuals admitted to a hospital with a new diagnosis of CRC were randomly selected after stratifying by hospital type (teaching or community). The Canadian Institute for Health Information's Discharge Abstract Database was used to identify individuals with a first diagnosis of CRC during calendar year (CY) 2000, and Ontario Health Insurance Plan data were used to identify people 50 to 74 years of age who had their first colonoscopy during CY 2000. Up to 20 individuals were selected for each group (CRC or colonoscopy) in each of seven randomly selected community hospitals and three randomly selected teaching hospitals. Data were abstracted from the hospital charts. RESULTS: The hospital charts of 152 patients with a new diagnosis of CRC were examined. Of the 133 patients in whom screening status could be determined, eight had screen-detected cancers (6.0%). Of the 99 patients (65% of the sample) in whom stage could be determined, 43 (43.4%) had advanced disease (tumour-node-metastasis stage III or IV) at diagnosis. The hospital charts of 184 patients who underwent their first colonoscopy were examined. Of the 175 patients in whom the indication for colonoscopy could be determined, 45 underwent the procedure for screening purposes, 10 were for diagnostic workup of anemia and 120 for evaluation of symptoms. CONCLUSIONS: The low proportion (6%) of screen-detected CRC and the high proportion of patients (43.4%) with advanced disease at diagnosis reflect the lack of an organized screening program.

Who provides gastrointestinal endoscopy in Canada?

PURPOSE: To determine who provides gastrointestinal endoscopy in Canada and to understand provincial and regional differences in endoscopy providers. METHODS: Aggregate physician sociodemographic and activity data for 2002 were obtained from the Canadian Institute of Health Information's National Physician Database. Physicians were classified as gastroenterologists, general surgeons and others. RESULTS: In 2002, 1444 physicians, including 735 surgeons, 551 gastroenterologists and 158 others, performed at least 100 colonoscopies or 100 gastroscopies. Gastroenterologists performed 53% of all colonoscopies and 59% of all gastroscopies. Gastroenterologists were the primary providers of colonoscopies in large urban areas, whereas surgeons were the primary providers in smaller urban and rural areas. An average of 317 colonoscopies were performed by surgeons, 516 by gastroenterologists and 203 by other physicians. The proportion of surgeon colonoscopists in each province ranged from 47% to 71%. CONCLUSIONS: Surgeons and gastroenterologists are the major providers of gastrointestinal endoscopy in Canada, but the distribution of these providers among provinces and urban and rural areas varies. Although surgeon endoscopists are more numerous, on average, they perform fewer procedures annually than internists.

Cancer Care Ontario Colonoscopy Standards: standards and evidentiary base.

Colorectal cancer (CRC) is the most common cause of non-tobacco-related cancer deaths in Canadian men and women, accounting for 10% of all cancer deaths. An estimated 7800 men and women will be diagnosed with CRC, and 3250 will die from the disease in Ontario in 2007. Given that CRC incidence and mortality rates in Ontario are among the highest in the world, the best opportunity to reduce this burden of disease would be through screening. The present report describes the findings and recommendations of Cancer Care Ontario's Colonoscopy Standards Expert Panel, which was convened in March 2006 by the Program in Evidence-Based Care. The recommendations will form the basis of the quality assurance program for colonoscopy delivered in support of Ontario's CRC screening program.

Estimating the impact of alcohol consumption on survival for HIV+ individuals.

Alcohol consumption is associated with decreased antiretroviral adherence, and decreased adherence results in poorer outcomes. However the magnitude of alcohol's impact on survival is unknown. Our objective was to use a calibrated and validated simulation of HIV disease to estimate the impact of alcohol on survival. We incorporated clinical data describing the temporal and dose-response relationships between alcohol consumption and adherence in a large observational cohort (N=2,702). Individuals were categorized as nondrinkers (no alcohol consumption), hazardous drinkers (consume > or =5 standard drinks on drinking days), and nonhazardous drinkers (consume <5 standard drinks on drinking days). Our results showed that nonhazardous alcohol consumption decreased survival by more than 1 year if the frequency of consumption was once per week or greater, and by 3.3 years (from 21.7 years to 18.4 years) with daily consumption. Hazardous alcohol consumption decreased overall survival by more than 3 years if frequency of consumption was once per week or greater, and by 6.4 years (From 16.1 years to 9.7 years) with daily consumption. Our results suggest that alcohol is an underappreciated yet modifiable risk factor for poor survival among individuals with HIV.

Accuracy of administrative health data for the diagnosis of upper gastrointestinal diseases.

BACKGROUND: The use of administrative health data is increasingly common for the study of various medical and surgical diseases. The validity of diagnosis codes for the study of benign upper gastrointestinal disorders has not been well studied. METHODS: The authors abstracted the charts for 590 adult patients who underwent upper gastrointestinal endoscopy between January 1, 2000 and June 30, 2001 in Toronto, Ontario, Canada. Clinical diagnoses from medical records were compared with International Classification of Diseases Version 9 (ICD-9) codes in electronic hospital discharge abstracts. The primary analysis aimed to determine the sensitivity, specificity, and positive predictive value (PPV) of a most responsible "esophagitis" diagnosis code for the prediction of esophagitis. Secondary analyses determined the performance characteristics of the diagnostic codes for esophageal ulcer, esophageal stricture, gastroesophageal reflux disease (GERD), gastritis, gastric ulcer, and duodenal ulcer. RESULTS: The authors linked 500 patient records to electronic discharge abstracts. When listed as the most responsible diagnosis for admission, the ICD-9 codes for esophagitis showed a sensitivity of 46.79%, a specificity of 98.83%, and a PPV of 94.81%. When listed as a secondary diagnosis, the ICD-9 codes showed a sensitivity of 70.51%, a specificity of 97.67%, and a PPV of 93.22%. The diagnostic properties of ICD-9 codes for GERD (most responsible, secondary) were as follows: sensitivity (56.10%, 78.66%), specificity (98.51%, 96.73%), and PPV (94.84%, 92.14%). CONCLUSIONS: The ICD-9 diagnosis codes for benign upper gastrointestinal diseases are highly specific and associated with strong PPVs, but have poor sensitivity.

Increased use of low anterior resection for veterans with rectal cancer.

BACKGROUND: Two surgical procedures with curative intent are available to patients with rectal cancer: lower anterior resection and abdominoperineal resection; however, lower anterior resection may improve quality of life and functional status. AIM: To examine temporal changes in after lower anterior resection and abdominoperineal resection between 1989 and 2000. Potential factors associated with the use of lower anterior resection were evaluated. METHODS: Using national administrative data, we identified patients who received lower anterior resection or abdominoperineal resection. Logistic regression models examined the association between use of lower anterior resection and time period of surgical resection. RESULTS: A total of 5201 rectal cancer patients underwent resection. The use of lower anterior resection increased from 40.0% (1989-91) to 50.1% (1998-2000) paralleled by a corresponding decline in abdominoperineal resection (60.1 to 49.9%; P < 0.001). Patients who received surgery during 1992-94, 1995-97 and 1998-2000 were 6, 7 and 28% more likely to receive lower anterior resection, when compared with 1989-1991 after adjusting for demographic characteristics, co-morbidity and hospital surgical volume. Older age, lower co-morbidity score and lower hospital surgical volume were predictive of lower anterior resection. CONCLUSIONS: An increase in the use of lower anterior resection for rectal cancer was observed over time. This observed increase in use is not confined to high-volume hospitals.

Dietary intake and the risk of gastro-oesophageal reflux disease: a cross sectional study in volunteers.

BACKGROUND: Although diet has been associated with gastro-oesophageal reflux disease (GORD), the role of dietary components (total energy, macro and micronutrients) is unknown. We examined associations of GORD symptoms with intakes of specific dietary components. METHODS: We conducted a cross sectional study in a sample of employees (non-patients) at the Houston VAMC. The Gastro Esophageal Reflux Questionnaire was used to identify the onset, frequency, and severity of GORD symptoms. Dietary intake (usual frequency of consumption of various foods and portion sizes) over the preceding year was assessed using the Block 98 food frequency questionnaire. Upper endoscopy was offered to all participants and oesophageal erosions recorded according to the LA classification. We compared the dietary intake (macronutrients, micronutrients, food groups) of participants with or without GORD symptoms, or erosive oesophagitis. Stepwise multiple logistic regression analyses were used to examine associations between nutrients and GORD symptoms or oesophageal erosions, adjusting for demographic characteristics, body mass index (BMI), and total energy intake. RESULTS: A total of 371 of 915 respondents (41%) had complete and interpretable answers to both heartburn and regurgitation questions and met validity criteria for the Block 98 FFQ. Mean age was 43 years, 260 (70%) were women, and 103 (28%) reported at least weekly occurrences of heartburn or regurgitation. Of the 164 respondents on whom endoscopies were performed, erosive oesophagitis was detected in 40 (24%). Compared to participants without GORD symptoms, daily intakes of total fat, saturated fat, cholesterol, percentage of energy from dietary fat, and average fat servings were significantly higher in participants with GORD symptoms. In addition, there was a dose-response relationship between GORD and saturated fat and cholesterol. The effect of dietary fat became non-significant when adjusted for BMI. However, high saturated fat, cholesterol, or fat servings were associated with GORD symptoms only in participants with a BMI >25 kg/m2 (effect modification). Fibre intake remained inversely associated with the risk of GORD symptoms in adjusted full models. Participants with erosive oesophagitis had significantly higher daily intakes of total fat and protein than those without it (p<0.05). CONCLUSIONS: In this cross sectional study, high dietary fat intake was associated with an increased risk of GORD symptoms and erosive oesophagitis while high fibre intake correlated with a reduced risk of GORD symptoms. It is unclear if the effects of dietary fat are independent of obesity.

Outcomes in elderly patients following surgery for colorectal cancer in the veterans affairs health care system.

AIM: To compare 30-day and 5-year mortality in elderly vs. younger patients following surgical resection for colorectal cancer. METHODS: A cohort study of patients admitted to VA hospitals with a new diagnosis of colorectal cancer who underwent surgical resection between October 1990 and September 2000. Cumulative survival rates (30-day and 5-year) were calculated from Kaplan-Meier estimates and adjusted risks of death were estimated using Cox proportional hazards models. RESULTS: We identified 34,888 individuals with a new diagnosis of colorectal cancer between October 1990 and September 2000, of whom 22 633 (65%) underwent surgical resection. The 30-day mortality following resection for rectal and colon cancer, respectively, for patients <65 years was 2.1 and 2.8% compared with 4.9 and 5.6% for those > or =65 years. The 5-year cumulative survival for rectal and colon cancer for patients <65 years was 54.0 and 57.6% compared with 44.5 and 46.6% for those > or =65 years. In patients > or =65 years with rectal or colon cancer, after adjustment, 30-day mortality was 2 times greater and 5-year mortality was 1 times greater than in younger patients. CONCLUSIONS: Older age is an independent predictor of increased short-term and long-term mortality following surgery in patients with rectal and colon cancer.

Association of hypocholesterolaemia with hepatitis C virus infection in HIV-infected people.

OBJECTIVE: To study the impact of hepatitis C virus (HCV) status on serum cholesterol levels in HIV-infected patients. METHODS: We retrospectively analysed data from the 881 participants of the Veterans Ageing Cohort 3 Site Study. Four different models were constructed using total cholesterol, low-density lipid (LDL) cholesterol, high-density lipid (HDL) cholesterol and triglycerides as dependent variables. The relevant covariates included HCV antibody status, HIV medication class, CD4 count, HIV viral load, glucose level, lipid-lowering drug use, gender, race, age, liver function test results, ethanol use, drug use, and HIV exposure category. Variables excluded from the final model included niacin use, gender, race, age, current ethanol use, and HIV exposure category. RESULTS: Of the 881 HIV-positive patients enrolled in the study, 700 (79%) were screened for HCV antibody, with 300 (42.8%) HCV antibody positive and 400 (57.2%) HCV antibody negative. A positive HCV antibody status was independently associated with lower total cholesterol levels (P=0.001) and LDL cholesterol levels (P<0.001) but not with lower HDL cholesterol or triglyceride levels. HCV-positive patients had predicted LDL levels 19 mg/dL lower than those of HCV-negative subjects. HCV infection was also associated with a decreased use of lipid-lowering medication, and protease inhibitor use was associated with increased LDL and total cholesterol levels. CONCLUSIONS: HCV infection has been associated with lower cholesterol levels in HIV-negative individuals, and the same appears to be true with HIV-infected patients. This is an interesting finding given that HCV particles bind to LDL receptors in vitro and also because HCV-lipid interactions appear to be important in the HCV replication cycle.

Measuring dyspepsia-related health in randomized trials: the Severity of Dyspepsia Assessment (SODA) and its use in treatment with NSAIDs and COX-2-specific inhibitors.

Dyspepsia is a common problem that is important from the perspectives of both patient health and economics. While there has been variability in the definitions used to describe dyspepsia, there have also been few standardized outcomes tools designed to measure dyspepsia-related health, especially in relation to changes in dyspepsia over time. An evaluative tool was developed, the Severity of Dyspepsia Assessment (SODA), which takes into account the multidimensional nature of dyspepsia using three scales (Pain, Non-pain Symptoms, and Satisfaction with Dyspepsia-related Health) and demonstrates good psychometric properties with respect to validity, reliability and sensitivity to change in the measurement of dyspepsia-related health. Although originally developed for the assessment of uninvestigated dyspepsia, the validation of SODA for use in clinical trials suggested its ability to compare treatment effects of non-specific non-steroidal anti-inflammatory drugs (NSAIDs) and cyclooxygenase (COX)-2-specific inhibitors. In comparative trials of celecoxib or valdecoxib with non-specific NSAIDs, COX-2-specific inhibitors were demonstrated to have superior dyspepsia tolerability than non-specific NSAIDs. These data demonstrate that SODA is an effective instrument for measuring dyspepsia-related health with a broad range of applications.