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1.
Endoscopy ; 41(3): 200-8, 2009 Mar.
Article in English | MEDLINE | ID: mdl-19280531

ABSTRACT

BACKGROUND AND STUDY AIMS: To summarize the published literature on assessment of appropriateness of colonoscopy for screening for colorectal cancer (CRC) in asymptomatic individuals without personal history of CRC or polyps, and report appropriateness criteria developed by an expert panel, the 2008 European Panel on the Appropriateness of Gastrointestinal Endoscopy, EPAGE II. METHODS: A systematic search of guidelines, systematic reviews, and primary studies regarding colonoscopy for screening for colorectal cancer was performed. The RAND/UCLA Appropriateness Method was applied to develop appropriateness criteria for colonoscopy in these circumstances. RESULTS: Available evidence for CRC screening comes from small case-controlled studies, with heterogeneous results, and from indirect evidence from randomized controlled trials (RCTs) on fecal occult blood test (FOBT) screening and studies on flexible sigmoidoscopy screening. Most guidelines recommend screening colonoscopy every 10 years starting at age 50 in average-risk individuals. In individuals with a higher risk of CRC due to family history, there is a consensus that it is appropriate to offer screening colonoscopy at < 50 years. EPAGE II considered screening colonoscopy appropriate above 50 years in average-risk individuals. Panelists deemed screening colonoscopy appropriate for younger patients, with shorter surveillance intervals, where family or personal risk of colorectal cancer is higher. A positive FOBT or the discovery of adenomas at sigmoidoscopy are considered appropriate indications. CONCLUSIONS: Despite the lack of evidence based on randomized controlled trials (RCTs), colonoscopy is recommended by most published guidelines and EPAGE II criteria available online (http://www.epage.ch), as a screening option for CRC in individuals at average risk of CRC, and undisputedly as the main screening tool for CRC in individuals at moderate and high risk of CRC.


Subject(s)
Colonoscopy , Colorectal Neoplasms/pathology , Europe , Guidelines as Topic , Humans , Randomized Controlled Trials as Topic
2.
Endoscopy ; 41(3): 209-17, 2009 Mar.
Article in English | MEDLINE | ID: mdl-19280532

ABSTRACT

BACKGROUND AND STUDY AIMS: To summarize the published literature on assessment of appropriateness of colonoscopy for surveillance after polypectomy and after curative-intent resection of colorectal cancer (CRC), and report appropriateness criteria developed by an expert panel, the 2008 European Panel on the Appropriateness of Gastrointestinal Endoscopy, EPAGE II. METHODS: A systematic search of guidelines, systematic reviews and primary studies regarding the evaluation and management of surveillance colonoscopy after polypectomy and after resection of CRC was performed. The RAND/UCLA Appropriateness Method was applied to develop appropriateness criteria for colonoscopy for these conditions. RESULTS: Most CRCs arise from adenomatous polyps. The characteristics of removed polyps, especially the distinction between low-risk adenomas (1 or 2, small [< 1 cm], tubular, no high-grade dysplasia) vs. high-risk adenomas (large [> or = 1 cm], multiple [> 3], high-grade dysplasia or villous features), have an impact on advanced adenoma recurrence. Most guidelines recommend a 3-year follow-up colonoscopy for high-risk adenomas and a 5-year colonoscopy for low-risk adenomas. Despite the lack of evidence to support or refute any survival benefit for follow-up colonoscopy after curative-intent CRC resection, surveillance colonoscopy is recommended by most guidelines. The timing of the first surveillance colonoscopy differs. The expert panel considered that 56 % of the clinical indications for colonoscopy for surveillance after polypectomy were appropriate. For surveillance after CRC resection, it considered colonoscopy appropriate 1 year after resection. CONCLUSIONS: Colonoscopy is recommended as a first-choice procedure for surveillance after polypectomy by all published guidelines and by the EPAGE II criteria. Despite the limitations of the published studies, colonoscopy is also recommended by most of the guidelines and by EPAGE II criteria for surveillance after curative-intent CRC resection.


Subject(s)
Colonoscopy , Colorectal Neoplasms/surgery , Intestinal Polyps/surgery , Europe , Guidelines as Topic , Humans , Postoperative Period
3.
Endoscopy ; 41(3): 218-26, 2009 Mar.
Article in English | MEDLINE | ID: mdl-19280533

ABSTRACT

BACKGROUND AND STUDY AIMS: To summarize the published literature on assessment of appropriateness of colonoscopy for investigation of chronic diarrhea, management of patients with known inflammatory bowel disease (IBD), and for colorectal cancer (CRC) surveillance in such patients, and to report report appropriateness criteria developed by an expert panel, the 2008 European Panel on the Appropriateness of Gastrointestinal Endoscopy, EPAGE II. METHODS: A systematic search of guidelines, systematic reviews, and primary studies regarding the evaluation of chronic diarrhea, the management of IBD, and colorectal cancer surveillance in IBD was performed. The RAND/UCLA Appropriateness Method was applied to develop appropriateness criteria for colonoscopy for these conditions. RESULTS: According to the literature, colonoscopic evaluation may be justified for patients aged > 50 years with recent-onset chronic diarrhea or with alarm symptoms. Surveillance colonoscopy for CRC should be offered to all patients with extensive ulcerative colitis or colonic Crohn's disease of 8 years' duration, and to all patients with less extensive disease of 15 years' duration. Intervals for surveillance colonoscopy depend on duration of evolution, initial diagnosis, and histological findings. The EPAGE II criteria also confirmed the appropriateness of diagnostic colonoscopy for diarrhea of > 4 weeks' duration. They also suggest that, in addition to assessing extent of IBD by colonoscopy, further colonoscopic examination is appropriate in the face of persistent or worsening symptoms. Surveillance colonoscopy in IBD patients was generally appropriate after a lapse of 2 years. In the presence of dysplasia at previous colonoscopy, it was not only appropriate but necessary. CONCLUSIONS: Despite or perhaps because of the limitations of the available published studies, the panel-based EPAGE II (http://www.epage.ch) criteria can help guide appropriate colonoscopy use in the absence of strong evidence from the literature.


Subject(s)
Colonoscopy , Diarrhea/pathology , Inflammatory Bowel Diseases/pathology , Chronic Disease , Colorectal Neoplasms/pathology , Europe , Guidelines as Topic , Humans
4.
Endoscopy ; 41(3): 227-33, 2009 Mar.
Article in English | MEDLINE | ID: mdl-19280534

ABSTRACT

BACKGROUND AND STUDY AIMS: To summarize the published literature on assessment of appropriateness of colonoscopy for the investigation of iron-deficiency anemia (IDA) and hematochezia, and report appropriateness criteria developed by an expert panel, the 2008 European Panel on the Appropriateness of Gastrointestinal Endoscopy, EPAGE II. METHODS: A systematic search of guidelines, systematic reviews and primary studies regarding the evaluation and management of IDA and hematochezia was performed. The RAND/UCLA Appropriateness Method was applied to develop appropriateness criteria for colonoscopy for these conditions. RESULTS: IDA occurs in 2 %-5 % of adult men and postmenopausal women. Examination of both the upper and lower gastrointestinal tract is recommended in patients with iron deficiency. Colonoscopy for IDA yields one colorectal cancer (CRC) in every 9-13 colonoscopies. Hematochezia is a well-recognized alarm symptom and such patients are likely to be referred for colonoscopy. Colonoscopy is unanimously recommended in patients aged > or = 50. Diverticulosis, vascular ectasias, and ischemic colitis are common causes of acute lower gastrointestinal bleeding (LGIB); CRC is found in 0.2 %-11 % of the colonoscopies performed for LGIB. Most patients with scant hematochezia have an anorectal or a distal source of bleeding. The expert panel considered most clinical indications for colonoscopy as appropriate in the presence of IDA (58 %) or hematochezia (83 %). CONCLUSION: Despite the limitations of the published studies, guidelines unanimously recommend colonoscopy for the investigation of IDA and hematochezia in patients aged > or = 50 years. These indications were also considered appropriate by EPAGE II, as were indications in patients at low risk for CRC with no obvious cause of bleeding found during adequate previous investigations.


Subject(s)
Anemia, Iron-Deficiency/pathology , Colonoscopy , Gastrointestinal Hemorrhage/pathology , Europe , Female , Guidelines as Topic , Humans , Male , Middle Aged
5.
Endoscopy ; 41(3): 234-9, 2009 Mar.
Article in English | MEDLINE | ID: mdl-19280535

ABSTRACT

BACKGROUND AND STUDY AIMS: To summarize the published literature on assessment of appropriateness of colonoscopy for the investigation of functional bowel symptoms, and report appropriateness criteria developed by an expert panel, the 2008 European Panel on the Appropriateness of Gastrointestinal Endoscopy, EPAGE II. METHODS: A systematic search of guidelines, systematic reviews and primary studies regarding the evaluation and management of functional bowel symptoms was performed. The RAND/UCLA Appropriateness Method was applied to develop appropriateness criteria for colonoscopy for these conditions. RESULTS: Much of the evidence for use of colonoscopy in evaluation of chronic abdominal pain, and/or constipation and/or abdominal bloating is modest. Major limitations include small numbers of patients and lack of adequate characterization of these patients. Large community-based follow-up studies are needed to enable better definition of the natural history of patients with functional bowel disorders. Guidelines stress that alarm features ("red flags"), such as rectal bleeding, anemia, weight loss, nocturnal symptoms, family history of colon cancer, age of onset > 50 years, and recent onset of symptoms should all lead to careful evaluation before a diagnosis of functional bowel disorder is made. EPAGE II assessed these symptoms by means of 12 clinical scenarios, rating colonoscopy as appropriate, uncertain and inappropriate in 42 % (5/12), 25 % (3/12), and 33 % (4/12) of these, respectively. CONCLUSIONS: Evidence to support the use of colonoscopy in the evaluation of patients with functional bowel disorders and no alarm features is lacking. These patients have no increased risk of colon cancer and thus advice on screening for this is not different from that for the general population. EPAGE II criteria, available online (http://www.epage.ch), consider colonoscopy appropriate in patients of > 50 years with chronic or new-onset bowel disturbances, but not in patients with isolated chronic abdominal pain.


Subject(s)
Abdominal Pain/pathology , Colonoscopy , Intestinal Diseases/pathology , Constipation/pathology , Europe , Guidelines as Topic , Humans , Middle Aged
6.
Endoscopy ; 41(3): 240-6, 2009 Mar.
Article in English | MEDLINE | ID: mdl-19280536

ABSTRACT

BACKGROUND AND STUDY AIMS: Appropriate use of colonoscopy is a key component of quality management in gastrointestinal endoscopy. In an update of a 1998 publication, the 2008 European Panel on the Appropriateness of Gastrointestinal Endoscopy (EPAGE II) defined appropriateness criteria for various colonoscopy indications. This introductory paper therefore deals with methodology, general appropriateness, and a review of colonoscopy complications. METHODS: The RAND/UCLA Appropriateness Method was used to evaluate the appropriateness of various diagnostic colonoscopy indications, with 14 multidisciplinary experts using a scale from 1 (extremely inappropriate) to 9 (extremely appropriate). Evidence reported in a comprehensive updated literature review was used for these decisions. Consolidation of the ratings into three appropriateness categories (appropriate, uncertain, inappropriate) was based on the median and the heterogeneity of the votes. The experts then met to discuss areas of disagreement in the light of existing evidence, followed by a second rating round, with a subsequent third voting round on necessity criteria, using much more stringent criteria (i. e. colonoscopy is deemed mandatory). RESULTS: Overall, 463 indications were rated, with 55 %, 16 % and 29 % of them being judged appropriate, uncertain and inappropriate, respectively. Perforation and hemorrhage rates, as reported in 39 studies, were in general < 0.1 % and < 0.3 %, respectively CONCLUSIONS: The updated EPAGE II criteria constitute an aid to clinical decision-making but should in no way replace individual judgment. Detailed panel results are freely available on the internet (www.epage.ch) and will thus constitute a reference source of information for clinicians.


Subject(s)
Colonoscopy/standards , Colonoscopy/adverse effects , Colonoscopy/methods , Europe , Humans , Treatment Outcome
7.
Rheumatology (Oxford) ; 47(2): 194-9, 2008 Feb.
Article in English | MEDLINE | ID: mdl-18178593

ABSTRACT

OBJECTIVES: There is a lack of agreement on assessing disease activity in patients with RA and determining when the RA treatment should be changed or continued. A panel of rheumatologists was convened to develop guidelines to assess adequacy of disease control, focusing on the use of disease-modifying anti-rheumatic drugs. METHODS: The Research and Development/University of California in Los Angeles (RAND/UCLA) Appropriateness Method was used to evaluate disease control adequacy. After a literature review, 108 scenarios were developed to simulate situations most likely to be encountered in clinical practice and rated on a 9-point scale by a 10-member expert panel. RESULTS: Final appropriateness rankings for the scenarios were as follows: 37% 'appropriate', 48% 'inappropriate', and 16% 'neutral'. The panelists felt that patients with disease control in the 'appropriate' range have adequate control with their current therapy, whereas those in the 'inappropriate' range should be considered for a change in therapy. Those in 'neutral' areas should have their therapy reviewed carefully. The panelists recommended that the clinically active joint count should be considered the most important decision factor. In patients with no clinically active joints, regardless of other factors no change in therapy was felt to be warranted. Patients with five or more active joints should be considered inadequately treated, and in patients with one to four active joints other variables must be considered in the decision to change therapy. CONCLUSION: These preliminary guidelines will assist the clinician in determining when a patient's clinical situation warrants therapy escalation and when continuing the current regimen would be appropriate.


Subject(s)
Antirheumatic Agents/therapeutic use , Arthritis, Rheumatoid/drug therapy , Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Antirheumatic Agents/classification , Antirheumatic Agents/standards , Clinical Trials as Topic/standards , Delivery of Health Care , Evaluation Studies as Topic , Evidence-Based Medicine , Humans , Predictive Value of Tests , Reproducibility of Results , Treatment Outcome
8.
Aliment Pharmacol Ther ; 27(4): 327-37, 2008 Feb 15.
Article in English | MEDLINE | ID: mdl-18005248

ABSTRACT

BACKGROUND: Respondents with gastro-oesophageal reflux disease (GERD) report having a variety of atypical manifestations. The relationship between these manifestations and disease severity, night-time GERD and functioning has not been determined. AIM: To determine if atypical manifestations are related to increased disease severity, night-time GERD and decreased functioning. METHODS: A web survey among US adults was conducted, using a validated GERD screener. Frequency of night-time and daytime typical symptoms (acid regurgitation and heartburn) and atypical manifestations were assessed. Respondents were classified as night-time GERD or daytime GERD based on typical symptom frequency. Prevalence of frequent atypical manifestations (> or =2 days or nights/week) was assessed. RESULTS: Gastro-oesophageal reflux disease cases had a higher prevalence of each atypical manifestation (P < 0.05 for all) compared with controls. Night-time GERD respondents had a higher prevalence of atypical manifestations compared with daytime GERD respondents (P < 0.05 for most manifestations) and the prevalence of atypical manifestations increased with GERD symptom severity (P < 0.05 for most). Those with atypical manifestations reported lower functioning scores (P < 0.05 for most). CONCLUSIONS: Respondents with typical GERD symptoms commonly report atypical manifestations, especially those with night-time symptoms and those with greater underlying GERD severity. Respondents with GERD and atypical manifestations had more impaired functioning than those with typical symptoms only.


Subject(s)
Circadian Rhythm , Gastroesophageal Reflux , Quality of Life , Severity of Illness Index , Adult , Cross-Sectional Studies , Female , Gastroesophageal Reflux/complications , Gastroesophageal Reflux/epidemiology , Gastroesophageal Reflux/psychology , Health Surveys , Humans , Male , Middle Aged , Prevalence , Surveys and Questionnaires
9.
Aliment Pharmacol Ther ; 25(4): 487-500, 2007 Feb 15.
Article in English | MEDLINE | ID: mdl-17270005

ABSTRACT

BACKGROUND: Effects of frequent nocturnal symptoms of gastro-oesophageal reflux disease (GERD-FNS) on health-related quality of life (HRQOL) and work productivity are not well documented. AIM: To assess symptom severity, production loss, and HRQOL among employed adults with and without GERD-FNS. METHODS: Using several validated outcome measures in a web survey design, GERD was pre-specified as GERD Symptom and Medication Questionnaire score >9, and > or =1 episode of heartburn or acid regurgitation during the preceding week. GERD-FNS patients were those reporting > or =2 symptom-nights during the previous week; their outcomes were compared with those of patients having minimal or no nocturnal symptoms (GERD-NNS) and vs. non-GERD controls. RESULTS: Data were collected from 1002 GERD patients (476 GERD-FNS, 526 GERD-NNS) and 513 controls. Severe symptoms were more common, sleep abnormalities were more frequent (P < 0.0001) and SF-36 scores lower (P < 0.05, all scores) among GERD-FNS patients vs. GERD-NNS patients. GERD-related work loss was greater among those with GERD-FNS vs. GERD-NNS (P < 0.0001). Work loss and functional limitations were more pronounced when comparing GERD-FNS cases vs. non-GERD controls. CONCLUSION: Employed adults with frequent nocturnal GERD report more severe symptoms, and are associated with impaired sleep, HRQOL and work productivity compared with controls and patients with minimal or no nocturnal symptoms.


Subject(s)
Efficiency , Gastroesophageal Reflux/psychology , Quality of Life , Activities of Daily Living , Adult , Attitude to Health , Female , Humans , Male , Middle Aged , Surveys and Questionnaires
10.
Aliment Pharmacol Ther ; 24(5): 751-67, 2006 Sep 01.
Article in English | MEDLINE | ID: mdl-16918879

ABSTRACT

BACKGROUND: Lower gastrointestinal effects of non-steroidal anti-inflammatory drugs (NSAIDs) are much more poorly characterized than upper gastrointestinal effects. AIM: To determine if NSAIDs increase lower gastrointestinal adverse effects and if the risk with non-selective NSAIDs is greater than with cyclooxygenase-2-selective inhibitors (coxibs). METHODS: Computerized databases were searched to identify studies of NSAID use reporting on lower gastrointestinal integrity (e.g. permeability), visualization (e.g. erosions, ulcers) and clinical events. RESULTS: Designs in 47 studies were randomized (18), case-control (14), cohort (eight) and before-after (seven). Non-selective-NSAIDs had significantly more adverse effects vs. no NSAIDs in 20 of 22 lower gastrointestinal integrity studies, five of seven visualization studies, seven of 11 bleeding studies (OR: 1.9-18.4 in case-control studies), two of two perforation studies (OR: 2.5-8.1) and five of seven diverticular disease studies (OR: 1.5-11.2). Coxibs had significantly less effect vs. non-selective-NSAIDs in three of four integrity studies, one endoscopic study (RR mucosal breaks: 0.3), and two randomized studies (RR lower gastrointestinal clinical events: 0.5; haematochezia: 0.4). CONCLUSIONS: An increase in lower gastrointestinal injury and clinical events with non-selective-NSAIDs appears relatively consistent across the heterogeneous collection of trials. Coxibs are associated with lower rates of lower gastrointestinal injury than non-selective-NSAIDs. More high-quality trials are warranted to more precisely estimate the effects of non-selective-NSAIDs and coxibs on the lower gastrointestinal tract.


Subject(s)
Anti-Inflammatory Agents, Non-Steroidal/adverse effects , Intestinal Diseases/chemically induced , Cyclooxygenase 2 Inhibitors/adverse effects , Diverticulum/chemically induced , Gastrointestinal Hemorrhage/chemically induced , Humans , Inflammation/chemically induced , Intestine, Large/drug effects , Intestine, Large/physiopathology , Intestine, Small/drug effects , Intestine, Small/physiopathology , Lower Gastrointestinal Tract , Permeability/drug effects
11.
Digestion ; 73(4): 237-48, 2006.
Article in English | MEDLINE | ID: mdl-16940727

ABSTRACT

BACKGROUND/AIMS: For many therapeutic decisions in Crohn's disease (CD), high-grade evidence is lacking. To assist clinical decision-making, explicit panel-based appropriateness criteria were developed by an international, multidisciplinary expert panel. METHODS: 10 gastroenterologists, 3 surgeons and 2 general practitioners from 12 European countries assessed the appropriateness of therapy for CD using the RAND Appropriateness Method. Their assessment was based on the study of a recent literature review of the subject, combined with their own expert clinical judgment. Panelists rated clinical indications and treatment options using a 9-point scale (1 = extremely inappropriate; 9 = extremely appropriate). These scenarios were then discussed in detail at the panel meeting and re-rated. Median ratings and disagreement were used to aggregate ratings into three assessment categories: appropriate (A), uncertain (U) and inappropriate (I). RESULTS: 569 specific indications were rated, dealing with 9 clinical presentations: mild/moderate luminal CD (n = 104), severe CD (n = 126), steroid-dependent CD (n = 25), steroid-refractory CD (n = 37), fistulizing CD (n = 49), fibrostenotic CD (n = 35), maintenance of medical remission of CD (n = 84), maintenance of surgical remission (n = 78), drug safety in pregnancy (n = 24) and use of infliximab (n = 7). Overall, 146 indications (26%) were judged appropriate, 129 (23%) uncertain and 294 (52%) inappropriate. Frank disagreement was low (14% overall) with the greatest disagreement (54% of scenarios) being observed for treatment of steroid-refractory disease. CONCLUSIONS: Detailed explicit appropriateness criteria for the appropriate use of therapy for CD were developed for the first time by a European expert panel. Disease location, severity and previous treatments were the main factors taken into account. User-friendly access to EPACT criteria is available via an Internet site, www.epact.ch, allowing prospective evaluation and improvement of appropriateness of current CD therapy.


Subject(s)
Crohn Disease/therapy , Endoscopy, Gastrointestinal/methods , Immunosuppressive Agents/therapeutic use , Practice Guidelines as Topic , Quality Assurance, Health Care/methods , Female , Humans , Observer Variation , Pregnancy , Pregnancy Complications/therapy , Remission Induction/methods , Severity of Illness Index
12.
Aliment Pharmacol Ther ; 19(2): 197-208, 2004 Jan 15.
Article in English | MEDLINE | ID: mdl-14723611

ABSTRACT

AIM: To rationalize decision making around the use of different non-steroidal anti-inflammatory drug (NSAID) treatment strategies in patients with varying degrees of gastrointestinal and cardiovascular risk. METHODS: The panel comprised nine physicians (three rheumatologists, two internists, two gastroenterologists and two cardiologists) from geographically diverse areas practising in community-based settings (n = 4) and academic institutions (n = 5). A literature review was performed by the authors on the risks, benefits and costs of NSAIDs, cyclo-oxygenase-2-specific inhibitors and proton pump inhibitor co-therapy. The RAND/UCLA Appropriateness Method was used to rate 304 clinical scenarios as 'appropriate', 'uncertain' or 'inappropriate'. RESULTS: In patients with no previous gastrointestinal event and not concurrently on aspirin (low risk), the panel rated the use of an NSAID alone as 'appropriate' for those aged < 65 years, and the use of an NSAID +proton pump inhibitor or cyclo-oxygenase-2-specific inhibitor + proton pump inhibitor as 'inappropriate'. For patients aged > 65 years and at low risk, an NSAID or cyclo-oxygenase-2-specific inhibitor alone was rated as 'uncertain'. For patients with a previous gastrointestinal event or who concurrently received aspirin, an NSAID alone was rated as 'inappropriate', and either a cyclo-oxygenase-2-specific inhibitor or an NSAID +proton pump inhibitor was rated as 'appropriate'. Finally, for patients with a previous gastrointestinal event and on aspirin, an NSAID or cyclo-oxygenase-2-specific inhibitor in conjunction with a proton pump inhibitor was rated as 'appropriate'. CONCLUSIONS: Clinicians and managed care entities need to balance the risks, benefits and costs of NSAIDs, cyclo-oxygenase-2-specific inhibitors and the prophylactic use of proton pump inhibitors. The guidelines given here can assist this process.


Subject(s)
Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Cardiovascular Diseases/chemically induced , Cyclooxygenase Inhibitors/therapeutic use , Gastrointestinal Diseases/chemically induced , Isoenzymes/antagonists & inhibitors , Practice Guidelines as Topic , Proton Pump Inhibitors , Cyclooxygenase 2 , Cyclooxygenase 2 Inhibitors , Humans , Membrane Proteins , Prostaglandin-Endoperoxide Synthases , Risk Factors
13.
Arch Dermatol ; 137(9): 1217-24, 2001 Sep.
Article in English | MEDLINE | ID: mdl-11559220

ABSTRACT

OBJECTIVES: To convene a multidisciplinary panel of dermatologists, surgical oncologists, and medical oncologists to formally review available data on the sentinel lymph node (SLN) biopsy procedure and high-dose adjuvant interferon alfa-2b therapy for patients with melanoma and to rate the "appropriateness," "inappropriateness," or "uncertainty" of the procedure and therapy to guide clinical decision making in practice. PARTICIPANTS: The panel comprised 13 specialists (4 dermatologists, 4 oncologists, and 5 surgeons) from geographically diverse areas who practiced in community-based settings (n = 8) and academic institutions (n = 5). Participants were chosen based on recommendations from the relevant specialty organizations. EVIDENCE: A formal literature review was conducted by investigators at Protocare Sciences Inc, Santa Monica, Calif, on the risks and benefits of performing an SLN biopsy in patients with stage I or II melanoma and adjuvant interferon alfa-2b therapy in patients with stage II or III disease. The MEDLINE database was searched from 1966 through July 2000, and supplemental information was obtained from various cancer societies and cancer research groups. Panel participants were queried on additional sources of relevant information. Unpublished, presented data were included in abstract form on 1 recently closed clinical trial. CONSENSUS PROCESS: The RAND/UCLA Appropriateness Method was used to review and rate multiple clinical scenarios for the use of SLN biopsy and interferon alfa-2b therapy. The consensus method did not force agreement. CONCLUSIONS: The panel rated 104 clinical scenarios and concluded that the SLN biopsy procedure was appropriate for primary melanomas deeper than 1.0 mm and for tumors 1 mm or less when histologic ulceration was present and/or classified as Clark level 4 or higher. The SLN biopsy was deemed inappropriate for nonulcerated Clark level 2 or 3 melanomas 0.75 mm or less in depth and uncertain in tumors 0.76 to 1.0 mm deep unless they were ulcerated or Clark level 4 or higher. Interferon alfa-2b therapy was deemed appropriate for patients with regional nodal and/or in-transit metastasis and for node-negative patients with primary melanomas deeper than 4 mm. The panel considered the use of interferon alfa-2b therapy uncertain in patients with ulcerated intermediate primary tumors (2.01-4.0 mm in depth) and inappropriate for node-negative patients with nonulcerated tumors less than 4.0 mm deep. Specialty-specific ratings were conducted as well.


Subject(s)
Evidence-Based Medicine , Interferon-alpha/therapeutic use , Melanoma/drug therapy , Sentinel Lymph Node Biopsy , Skin Neoplasms/drug therapy , Chemotherapy, Adjuvant , Dose-Response Relationship, Drug , Humans , Interferon alpha-2 , Interferon-alpha/adverse effects , Melanoma/pathology , Melanoma/surgery , Neoplasm Staging , Patient Care Team , Recombinant Proteins , Skin Neoplasms/pathology , Skin Neoplasms/surgery
14.
Gastrointest Endosc ; 52(5): 593-99, 2000 Nov.
Article in English | MEDLINE | ID: mdl-11060181

ABSTRACT

BACKGROUND: Efforts to decrease overuse of health care may result in underuse. Overuse and underuse of colonoscopy have never been simultaneously evaluated in the same patient population. METHODS: In this prospective observational study, the appropriateness and necessity of referral for colonoscopy were evaluated by using explicit criteria developed by a standardized expert panel method. Inappropriate referrals constituted overuse. Patients with necessary colonoscopy indications who were not referred constituted underuse. Consecutive ambulatory patients with lower gastrointestinal (GI) symptoms from 22 general practices in Switzerland, a country with ready access to colonoscopy, were enrolled during a 4-week period. Follow-up data were obtained at 3 months for patients who did not undergo a necessary colonoscopy. RESULTS: Eight thousand seven hundred sixty patient visits were screened for inclusion; 651 patients (7.4%) had lower GI symptoms (mean age 56.4 years, 68% women). Of these, 78 (12%) were referred for colonoscopy. Indications for colonoscopy in 11 patients (14% of colonoscopy referrals or 1.7% of all patients with lower GI symptoms) were judged inappropriate. Among 573 patients not referred for the procedure, underuse ranged between 11% and 28% of all patients with lower GI symptoms, depending on the criteria used. CONCLUSIONS: Applying criteria from an expert panel of nationally recognized experts indicates that underuse of referral for colonoscopy exceeds overuse in primary care in Switzerland. To improve quality of care, both overuse and underuse of important procedures must be addressed.


Subject(s)
Colonoscopy/statistics & numerical data , Female , Follow-Up Studies , Humans , Male , Middle Aged , Primary Health Care , Prospective Studies , Switzerland
15.
Gastrointest Endosc ; 52(3): 333-41, 2000 Sep.
Article in English | MEDLINE | ID: mdl-10968846

ABSTRACT

BACKGROUND: Increasing the appropriateness of use of upper gastrointestinal (GI) endoscopy is important to improve quality of care while at the same time containing costs. This study explored whether detailed explicit appropriateness criteria significantly improve the diagnostic yield of upper GI endoscopy. METHODS: Consecutive patients referred for upper GI endoscopy at 6 centers (1 university hospital, 2 district hospitals, 3 gastroenterology practices) were prospectively included over a 6-month period. After controlling for disease presentation and patient characteristics, the relationship between the appropriateness of upper GI endoscopy, as assessed by explicit Swiss criteria developed by the RAND/UCLA panel method, and the presence of relevant endoscopic lesions was analyzed. RESULTS: A total of 2088 patients (60% outpatients, 57% men) were included. Analysis was restricted to the 1681 patients referred for diagnostic upper GI endoscopy. Forty-six percent of upper GI endoscopies were judged to be appropriate, 15% uncertain, and 39% inappropriate by the explicit criteria. No cancer was found in upper GI endoscopies judged to be inappropriate. Upper GI endoscopies judged appropriate or uncertain yielded significantly more relevant lesions (60%) than did those judged to be inappropriate (37%; odds ratio 2.6: 95% CI [2.2, 3.2]). In multivariate analyses, the diagnostic yield of upper GI endoscopy was significantly influenced by appropriateness, patient gender and age, treatment setting, and symptoms. CONCLUSIONS: Upper GI endoscopies performed for appropriate indications resulted in detecting significantly more clinically relevant lesions than did those performed for inappropriate indications. In addition, no upper GI endoscopy that resulted in a diagnosis of cancer was judged to be inappropriate. The use of such criteria improves patient selection for upper GI endoscopy and can thus contribute to efforts aimed at enhancing the quality and efficiency of care. (Gastrointest Endosc 2000;52:333-41).


Subject(s)
Endoscopy, Gastrointestinal/standards , Gastrointestinal Diseases/diagnosis , Quality Assurance, Health Care/methods , Adult , Aged , Diagnosis, Differential , Female , Humans , Male , Middle Aged , Patient Selection , Prospective Studies , Quality Assurance, Health Care/standards
16.
Spine (Phila Pa 1976) ; 25(14): 1831-6, 2000 Jul 15.
Article in English | MEDLINE | ID: mdl-10888953

ABSTRACT

STUDY DESIGN: Reliability study of guidelines development. OBJECTIVE: To compare criteria for low back surgery between two expert panels. BACKGROUND: Reliability of expert panels for determining appropriateness of indications for surgical procedures has heretofore received little attention. METHODS: Two multidisciplinary expert panels of similar composition were convened, in the United States and in Switzerland, to evaluate the appropriateness of 720 distinct clinical scenarios involving sciatica. Each indication was assigned to a category of appropriate, uncertain, and inappropriate. The appropriateness of the 720 theoretical scenarios were compared between the two panels, and both sets of criteria were applied to two series of actual cases. RESULTS: Seventy-nine percent (n = 566) of the 720 theoretical indications were assigned to identical categories of appropriateness by both panels (kappa = 0.63; P < 0.001). Only 2 of the 720 scenarios elicited frank disagreement. The percentage of the 720 indications that were considered appropriate differed between the two panels (U.S.: 3%; Swiss: 11%, P < 0.001), as did the percentage of intrapanel agreement for indications (U.S.: 51%, Swiss: 64%, P < 0.001). When the same theoretical scenarios were matched with two series of actual cases (n = 181 and 149) agreement was moderate (kappa = 0.46) to fair (kappa = 0.30). CONCLUSION: There was substantial agreement on the appropriateness of surgery for theoretical cases of sciatica between independent expert panels from two countries. A better understanding of discordant ratings, especially for actual cases, should precede attempts at transposing recommendations emanating from a panel in one country to another.


Subject(s)
Expert Testimony , Laminectomy/standards , Lumbar Vertebrae/surgery , Practice Guidelines as Topic/standards , Sciatica/surgery , Guidelines as Topic , Health Services Misuse , Humans , Laminectomy/statistics & numerical data , Outcome and Process Assessment, Health Care , Reproducibility of Results , Switzerland , United States
17.
Health Aff (Millwood) ; 19(2): 231-9, 2000.
Article in English | MEDLINE | ID: mdl-10718037

ABSTRACT

Several recent studies have made clear that drug expenditures are rising more rapidly than other health care spending. What has not been clear, however, is how much drug spending is driven by price rather than volume and whether volume increases are appropriate. This DataWatch takes a closer look at the components and drivers of drug spending using large claims databases from managed care and employer-sponsored health benefit plans. In both environments this study found volume, not price, to be the largest driver of drug spending for seven diseases studied. For four of the diseases, we review the clinical issues that may have influenced volume growth.


Subject(s)
Drug Costs/statistics & numerical data , Drug Costs/trends , Drug Utilization/economics , Drug Utilization/trends , Health Expenditures/statistics & numerical data , Health Expenditures/trends , Insurance Claim Reporting/statistics & numerical data , Insurance Claim Reporting/trends , Centers for Medicare and Medicaid Services, U.S. , Chronic Disease/drug therapy , Health Benefit Plans, Employee/economics , Health Benefit Plans, Employee/statistics & numerical data , Health Policy , Humans , Managed Care Programs/economics , Managed Care Programs/statistics & numerical data , United States
18.
Health Care Financ Rev ; 21(3): 65-91, 2000.
Article in English | MEDLINE | ID: mdl-11481768

ABSTRACT

The authors discuss a system that describes the resources needed to treat different subgroups of the population under age 65, based on burden of disease. It is based on 173 conditions, each with up to 3 severity levels, and contains models that combine prospective diagnoses with retrospectively determined elements. We used data from four different payers and standardized the cost of most services. Analyses showed that the models are replicable, are reasonably accurate, explain costs across payers, and reduce rewards for biased selection. A prospective model with additional payments for birth episodes and for serious problems in newborns would be an effective risk adjuster for Medicaid programs.


Subject(s)
Cost of Illness , Disease/classification , Episode of Care , Health Resources/economics , Models, Econometric , Risk Adjustment/economics , Severity of Illness Index , Adolescent , Adult , Child , Child, Preschool , Disease/economics , Female , Humans , Infant , Infant, Newborn , Male , Medicaid , Michigan , Middle Aged , United States
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