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1.
BJOG ; 128(9): 1503-1510, 2021 08.
Article in English | MEDLINE | ID: mdl-33982870

ABSTRACT

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.


Subject(s)
COVID-19/prevention & control , Colposcopy/statistics & numerical data , Uterine Cervical Neoplasms/diagnosis , Uterine Cervical Neoplasms/therapy , Vaginal Smears/statistics & numerical data , Adult , Aged , Databases, Factual , Delivery of Health Care/statistics & numerical data , Early Detection of Cancer/statistics & numerical data , Female , Humans , Middle Aged , Ontario , SARS-CoV-2 , Young Adult
2.
BMC Public Health ; 21(1): 1496, 2021 08 03.
Article in English | MEDLINE | ID: mdl-34344340

ABSTRACT

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.


Subject(s)
Mass Screening , Public Health , Adult , Chronic Disease , Humans , Middle Aged , Ontario , Primary Health Care
3.
Curr Oncol ; 24(1): 47-51, 2017 Feb.
Article in English | MEDLINE | ID: mdl-28270725

ABSTRACT

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.

5.
Gut ; 64(8): 1257-67, 2015 Aug.
Article in English | MEDLINE | ID: mdl-25193802

ABSTRACT

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.


Subject(s)
Colonoscopy , Colorectal Neoplasms/classification , Colorectal Neoplasms/diagnosis , Early Detection of Cancer/methods , Mass Screening , Terminology as Topic , Humans
6.
Gut ; 64(1): 121-32, 2015 Jan.
Article in English | MEDLINE | ID: mdl-24647008

ABSTRACT

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.


Subject(s)
Colorectal Neoplasms/diagnosis , Early Detection of Cancer/standards , Aged , Asia , Humans , Middle Aged
7.
Gut ; 58(11): 1490-7, 2009 Nov.
Article in English | MEDLINE | ID: mdl-19651626

ABSTRACT

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.


Subject(s)
Algorithms , Databases, Factual/statistics & numerical data , Inflammatory Bowel Diseases/epidemiology , Adolescent , Age Distribution , Child , Child, Preschool , Female , Humans , Incidence , Infant , Male , Ontario/epidemiology , Poisson Distribution , Prevalence
8.
Surg Endosc ; 21(10): 1733-7, 2007 Oct.
Article in English | MEDLINE | ID: mdl-17285379

ABSTRACT

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.


Subject(s)
Databases, Factual , Duodenal Ulcer/diagnosis , Endoscopy, Gastrointestinal , Esophageal Diseases/diagnosis , Medical Records/standards , Stomach Diseases/diagnosis , Adult , Cross-Sectional Studies , Female , Humans , Male , Reproducibility of Results
9.
Can J Gastroenterol ; 21(12): 843-6, 2007 Dec.
Article in English | MEDLINE | ID: mdl-18080058

ABSTRACT

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.


Subject(s)
Endoscopy, Gastrointestinal/statistics & numerical data , Practice Patterns, Physicians' , Canada , Humans
10.
Can J Gastroenterol ; 21(12): 805-8, 2007 Dec.
Article in English | MEDLINE | ID: mdl-18080051

ABSTRACT

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.


Subject(s)
Colonoscopy/methods , Colorectal Neoplasms/epidemiology , Mass Screening/methods , Adult , Aged , Aged, 80 and over , Colorectal Neoplasms/diagnosis , Female , Humans , Male , Middle Aged , Neoplasm Staging , Ontario/epidemiology , Prevalence , Retrospective Studies
11.
Can J Gastroenterol ; 21 Suppl D: 5D-24D, 2007 Nov.
Article in English | MEDLINE | ID: mdl-18026582

ABSTRACT

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.


Subject(s)
Adenoma/diagnosis , Colonoscopy/standards , Colorectal Neoplasms/diagnosis , Mass Screening/standards , Clinical Competence , Conscious Sedation , Evidence-Based Medicine , Humans , Minimally Invasive Surgical Procedures/education , Ontario , Quality Assurance, Health Care , Resuscitation
12.
Best Pract Res Clin Gastroenterol ; 30(3): 389-96, 2016 Jun.
Article in English | MEDLINE | ID: mdl-27345647

ABSTRACT

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.


Subject(s)
Cost-Benefit Analysis , Endoscopy, Gastrointestinal/economics , Endoscopy, Gastrointestinal/education , Health Personnel/education , Colorectal Neoplasms/prevention & control , Early Detection of Cancer , Feasibility Studies , Humans , Program Evaluation
13.
Can J Gastroenterol Hepatol ; 2016: 1929361, 2016.
Article in English | MEDLINE | ID: mdl-27579299

ABSTRACT

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.


Subject(s)
Colonoscopy/standards , Documentation/standards , Quality Assurance, Health Care , Quality Indicators, Health Care , Clinical Competence , Colonic Polyps/diagnosis , Colonoscopy/statistics & numerical data , Gastroenterology , Humans , Ontario , Time Factors
14.
Aliment Pharmacol Ther ; 21(1): 35-41, 2005 Jan 01.
Article in English | MEDLINE | ID: mdl-15644043

ABSTRACT

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.


Subject(s)
Rectal Neoplasms/surgery , Adult , Aged , Aged, 80 and over , Cohort Studies , Female , Health Facility Size , Hospitals/statistics & numerical data , Humans , Male , Middle Aged , Odds Ratio , Quality of Life , Time Factors
15.
Arch Intern Med ; 154(23): 2705-10, 1994.
Article in English | MEDLINE | ID: mdl-7993154

ABSTRACT

BACKGROUND: Currently no consensus exists concerning the timing of upper endoscopy and the choice of antifungal therapy for patients infected with the human immunodeficiency virus who also have esophageal candidiasis. The objective of this research was to determine the clinical and economic effects of alternative management strategies for these patients. METHODS: Decision analysis was used to evaluate the outcomes, costs, and cost-effectiveness of two strategies for the diagnostic workup and treatment of patients infected with the human immunodeficiency virus with dysphagia and/or odynophagia: (1) empiric--a strategy to treat all patients empirically with an oral antifungal agent for up to 4 weeks; and (2) initial esophagogastroduodenoscopy (EGD)--a strategy to perform EGD on all patients and to treat only those with esophageal candidiasis with an oral antifungal agent for up to 4 weeks. Within each strategy, three antifungal regimens were evaluated: ketoconazole, 200 mg daily; fluconazole, 100 mg daily; and ketoconazole, 200 mg daily, for 2 weeks followed by fluconazole, 200 mg daily, for 2 weeks in nonresponders. Information on the probability of esophageal candidiasis in patients with esophageal symptoms and the efficacy of antifungal therapy was obtained from the literature. The costs for diagnostic workup were estimated using both teaching hospital charges and Medicare reimbursement payments. The costs of antifungal therapy were estimated from local pharmacy charges. The average cost per complete response and incremental cost-effectiveness were calculated and subjected to sensitivity analysis. RESULTS: Using the best available evidence for antifungal efficacy, empiric fluconazole was the most cost-effective strategy for all probabilities of esophageal candidiasis that were more than 0.55. Using teaching hospital charges in our base-case analysis, the average costs per complete response for empiric fluconazole and initial EGD and fluconazole were $2706 and $3141, respectively. The incremental cost-effectiveness of initial EGD and fluconazole compared with empiric fluconazole was $3792 per additional complete response. When the cost-effectiveness of the two strategies was compared as the cost of diagnostic workup was varied, initial EGD and fluconazole became the dominant strategy when the diagnostic workup cost fell below $710, a figure that is less than the current Medicare reimbursement payment. CONCLUSIONS: From the perspective of the payer of medical care, empiric fluconazole is the most cost-effective strategy for the initial management of patients infected with the human immunodeficiency virus with esophageal symptoms.


Subject(s)
AIDS-Related Opportunistic Infections/economics , Antifungal Agents/economics , Candidiasis/economics , Endoscopy, Digestive System/economics , Esophageal Diseases/economics , AIDS-Related Opportunistic Infections/diagnosis , AIDS-Related Opportunistic Infections/drug therapy , Antifungal Agents/therapeutic use , Candidiasis/diagnosis , Candidiasis/drug therapy , Candidiasis/virology , Cost-Benefit Analysis , Decision Trees , Esophageal Diseases/diagnosis , Esophageal Diseases/drug therapy , Esophageal Diseases/virology , Humans , Probability , Time Factors
16.
Arch Intern Med ; 153(24): 2749-55, 1993 Dec 27.
Article in English | MEDLINE | ID: mdl-8257250

ABSTRACT

An important determinant of patient outcomes is illness severity, which must be classified to guide clinical decision making and evaluate the effectiveness of diagnostic and therapeutic interventions. Currently, no widely accepted framework for grading illness severity in human immunodeficiency virus-infected patients exists. The best known classification systems for human immunodeficiency virus infection (Centers for Disease Control and Prevention; Walter Reed) are not based on illness severity, and provide stages that are not all inclusive so that a large number of persons cannot be classified (Walter Reed). Although much previous research has focused on individual prognostic factors (oral thrush, CD4 cell count, serum beta 2-microglobulin), little attention has been given to incorporating these factors into illness severity scales that are easy to use in clinical settings. In addition, despite the progressive functional disability of human immunodeficiency virus-infected individuals, few of the existing approaches to illness severity classification have examined the contribution of functional status. We urge investigators to develop clinically sensible severity scales that are easy to use. Such scales will considerably improve existing approaches that tend to rely solely on the CD4 cell count and do not take into account the known prognostic effects of other variables.


Subject(s)
HIV Infections/physiopathology , Acquired Immunodeficiency Syndrome/physiopathology , HIV Infections/classification , HIV Infections/complications , HIV Infections/immunology , Humans , Predictive Value of Tests , Prognosis , Severity of Illness Index
17.
Arch Intern Med ; 152(3): 507-12, 1992 Mar.
Article in English | MEDLINE | ID: mdl-1546913

ABSTRACT

To achieve the goal of validity, the randomized clinical trial has emerged as the scientific "gold standard" for evaluating therapies in clinical medicine. Regardless of how well randomized clinical trials are designed, however, problems often occur during the conduct of the trials that give rise to methodologic challenges in the analysis of results. Primarily two types of problems, changes in intended treatment and the failure to ascertain the study outcomes, occur during the conduct of randomized clinical trials. We studied the current analytic strategies that are used to deal with these problems and how the use of these analytic strategies can change the focus of the research so that the trial no longer answers the relevant question. To ensure that the right question is answered, new methods of design and analysis are required that balance the goals of validity and clinical pertinence.


Subject(s)
Randomized Controlled Trials as Topic/methods , Evaluation Studies as Topic , Follow-Up Studies , Patient Compliance , Research Design , Research Subjects , Treatment Outcome
18.
Am J Med ; 91(6): 566-72, 1991 Dec.
Article in English | MEDLINE | ID: mdl-1750424

ABSTRACT

INTRODUCTION: Helicobacter pylori (HP) in the gastric antrum has been strongly associated with both duodenal ulcer (DU) and chronic active gastritis (CAG). The relationship between HP and DU has been interpreted as causal by many observers. An alternate hypothesis is that HP coincidently colonizes CAG, which is independently associated with DU by some yet-unknown mechanism. PURPOSE: To assess the extent to which a causal relationship between HP and DU has been demonstrated, we performed a methodologic critique of published clinical studies. We carried out a literature search to identify clinical studies that included at least 25 subjects. Of the eight studies we identified, six used a cross-sectional design and two used a prospective cohort design. We applied methodologic criteria to assess causation: strength of association, biologic gradient, temporality, and experiment. METHODS: A strong association between HP and DU was demonstrated in all eight studies. Biologic gradient and temporality were not assessed in any study. In the two experimental studies of therapy, loss of antral HP was associated with a decreased rate of DU relapse; however, we did not interpret this as sufficient to support causality because the effect may have been due to a direct mucosal action rather than eradication of HP. CONCLUSION: We conclude that published evidence does not establish HP as a cause of DU. One approach to address causality would be an observational cohort study of ulcer relapse to assess the temporal relationships between HP, CAG, and DU.


Subject(s)
Duodenal Ulcer/microbiology , Helicobacter Infections/complications , Helicobacter pylori , Cohort Studies , Cross-Sectional Studies , Duodenal Ulcer/etiology , Helicobacter pylori/isolation & purification , Humans , Stomach/microbiology
19.
Am J Med ; 106(3): 335-46, 1999 Mar.
Article in English | MEDLINE | ID: mdl-10190384

ABSTRACT

PURPOSE: Dyspepsia is a common primary care condition, yet its optimal management is poorly defined. We reviewed the literature to answer the following questions about patients with dyspepsia: 1) Does endoscopy result in improved patient outcomes? 2) Does endoscopy result in a reduction in the use of subsequent medical resources? 3) Does endoscopy result in improved medical decision making? 4) Is endoscopy cost effective? METHODS: We performed a systematic review of English-language articles in the MEDLINE, HEALTHSTAR, and EMBASE computerized bibliographic databases from January 1985 to July 1998. We included all studies, including decision analyses, with information about the effectiveness of endoscopy, as measured by its impact on patient outcomes, resource utilization, clinical decision making, or cost effectiveness. Two independent reviewers abstracted data from each study, and assessed its methodologic quality. RESULTS: Twenty-one studies met the inclusion criteria. For 3 of the 4 clinical questions, the weight of evidence does not support the effectiveness of endoscopy. The largest randomized clinical trial comparing endoscopy with empiric therapy demonstrates equivalent symptoms and quality of life at 1 year, with increased patient satisfaction and lower costs for initial endoscopy. Suboptimal study design, including lack of appropriate comparison groups, limit studies measuring the impact of endoscopy on resource utilization and decision-making. Decision analyses indicate that noninvasive H pylori testing followed by anti-H pylori therapy or empiric antisecretory therapy is more cost effective than initial endoscopy. CONCLUSIONS: With the exception of one randomized clinical trial, the preponderance of available data does not support the effectiveness of endoscopy in the management of dyspepsia. Prospective clinical trials that evaluate patient outcomes and resource utilization, and take H pylori status into account, are needed to determine the effectiveness of endoscopy in the management of dyspepsia.


Subject(s)
Dyspepsia/therapy , Endoscopy, Digestive System , Anxiety/etiology , Cost-Benefit Analysis , Decision Making , Dyspepsia/microbiology , Endoscopy, Digestive System/economics , Health Resources/statistics & numerical data , Helicobacter Infections/complications , Helicobacter pylori , Humans , Patient Satisfaction , Quality of Life , Randomized Controlled Trials as Topic , Treatment Outcome , United States
20.
Am J Med ; 95(1): 61-70, 1993 Jul.
Article in English | MEDLINE | ID: mdl-8328498

ABSTRACT

PURPOSE: (1) To test the hypothesis that the clinical features of patients with acute pancreatitis could be used to construct a new prognostic staging system, and (2) to compare the new system with the results of the existing Ranson system based on age and laboratory data. PATIENTS AND METHODS: We obtained an inception cohort of 162 persons with 176 episodes of acute pancreatitis admitted to Yale-New Haven Hospital from January 1, 1987, to March 31, 1989. RESULTS: The main adverse outcome events, death and/or complications, occurred in 22% of episodes. Acute pancreatitis severity was classified in three stages, reflecting the presence of only primary features (no ileus or peritonitis), or the occurrence of secondary features that could be mild (mild ileus) or severe (severe ileus and/or peritonitis). In these 3 stages, the respective rates for outcome events were 13% (17 of 133), 43% (13 of 30), and 62% (8 of 13). The severity of comorbidity was classified according to Charlson's comorbidity index. For the 3 comorbidity stages, the outcome event rates were: minimal: 13% (12 of 92); intermediate: 22% (11 of 49); and severe: 43% (15 of 35). When the acute pancreatitis severity stages and comorbidity stages were conjoined to form the composite staging system, the corresponding outcome event rates were stage I: 8 of 107 (7%); stage II: 24 of 60 (40%); and stage III: 6 of 9 (67%). The composite staging system produced sharper gradients for the outcome events than Ranson's system, and was more readily applicable to all patients, particularly when the requisite special laboratory tests had not been ordered. CONCLUSIONS: The clinical and comorbid features of patients with acute pancreatitis can be used to construct a clinically "sensible" composite staging system. The stages are easy to use, require no additional or special laboratory tests, and predict more accurately than Ranson's system.


Subject(s)
Pancreatitis/classification , Acute Disease , Adolescent , Adult , Aged , Aged, 80 and over , Analysis of Variance , Cohort Studies , Female , Humans , Male , Middle Aged , Pancreatitis/complications , Pancreatitis/etiology , Pancreatitis/physiopathology , Prognosis , Severity of Illness Index , Treatment Outcome
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