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Introduction: Drive line infections (DLIs) are common complications of left ventricular assist devices (LVADs). Data on use of suppression antibiotic therapy are limited., Methods: We performed a retrospective review of 451 patients who underwent LVAD placement from January 2009 to May 2015. First superficial DLIs were included for analysis. We examined factors associated with the use of chronic suppressive antibiotics (CSAs) therapy. Cox proportional hazards models were performed to identify factors associated with DLI relapse with the same organism as the initial DLI., Results: A total of 69 patients developed a superficial DLI within a median of 195 (interquartile range [IQR] 98-348) days of LVAD insertion. The median age was 57 years, 87% were males, and 74% were White. Gram positive bacteria caused 61% of infections, with Staphylococcus aureus being the most common (35%). Forty-three (62%) patients received suppressive antibiotic therapy. Relapse DLI occurred in 29 (42%) patients. Independent risk factors for relapse infection in multivariable analysis were sepsis (aHR 5.94 [CI 1.42-24.92]), and MRSA DLI (aHR 4.19 [CI 1.37-12.79]). There was no difference in the proportion of patients with relapse among those who were treated with antibiotic suppression therapy versus not (44% vs. 38%, p = 0.64), although relapse occurred at a later time in those who received suppression (185 vs. 69 days, p < 0.01)., Conclusion: CSA therapy was associated with delayed time to DLI relapse but no significant difference in the proportion of patients with relapse. A prospective study is needed to examine the effect of suppression on relapse rates., (© 2021 Wiley Periodicals LLC.)

Orthotropic heart transplantation remains the most effective therapy for patients with end-stage heart failure, with a median survival of ≈13 years. Yet, a number of complications are observed after orthotropic heart transplantation, including atrial and ventricular arrhythmias. Several factors contribute to arrhythmias, such as autonomic denervation, effect of the surgical technique, acute and chronic rejection, and transplant vasculopathy among others. To minimize risk of future arrhythmias, the bicaval technique and minimizing ischemic time are current surgical standards. Sinus node dysfunction is the most common indication for early (within 30 days) pacemaker implantation, whereas atrioventricular block incidence increases as time from transplant increases. Atrial fibrillation can occur in the first few weeks following transplantation but is uncommon in the long term unless secondary to a precipitant such as acute rejection. The most common atrial arrhythmias are atrial flutters, which are mainly typical, but atypical circuits can be observed such as those that involve the remnant donor atrium in regions immediately adjacent to the atrioatrial anastomosis suture line. Choosing the appropriate pharmacological therapy requires careful consideration due to the potential interaction with immunosuppressive agents. Despite historical concerns, adenosine is effective and safe at reduced doses if administered under cardiac monitoring. Catheter ablation has emerged as an effective treatment strategy for symptomatic supraventricular tachycardias, including ablation of atypical flutter circuits. Cardiac allograft vasculopathy is an important risk factor for sudden cardiac death, yet the role of prophylactic implantable cardioverter-defibrillator implant for sudden death prevention is unclear. Current indications for implantable cardioverter-defibrillator implantation are as in the nontransplant population. A number of questions for future research are posed.

Sacubitril/valsartan is a first-in-class angiotensin receptor-neprilysin inhibitor (ARNI) that has been recommended in clinical practice guidelines to reduce morbidity and mortality in patients with chronic, symptomatic heart failure (HF) with reduced ejection fraction (HFrEF). This review provides an overview of ARNI therapy, proposes strategies to improve the implementation of sacubitril/valsartan in clinical practice, and provides clinicians with evidence-based, practical guidance on the use of sacubitril/valsartan in patients with HFrEF. Despite evidence demonstrating the benefits of ARNI therapy over standard of care, only a fraction of eligible patients takes sacubitril/valsartan. Barriers preventing the prescription of sacubitril/valsartan in eligible patients may include practitioners' unfamiliarity with ARNIs, safety concerns, and payer reimbursement issues. The optimal implementation of sacubitril/valsartan in clinical practice has the potential to reduce the overall burden of HF. Throughout this review, we describe our experience with sacubitril/valsartan, including strategies for the management of adverse events and common patient concerns. In addition, a strategy for the gradual introduction of sacubitril/valsartan using a treatment sequence scheme is proposed.

Aims: Obesity is present in up to 45% of patients with heart failure (HF). Liraglutide, a glucagon-like peptide-1 (GLP-1) receptor antagonist, facilitates weight loss in obese patients. The efficacy of liraglutide as a weight loss agent among patients with HF and reduced ejection fraction (HFrEF) and a recent acute HF hospitalization remains unknown., Methods and Results: The Functional Impact of GLP-1 for Heart Failure Treatment study randomized 300 patients with HFrEF (ejection fraction ≤ 40%), both with and without diabetes and a recent HF hospitalization to liraglutide or placebo. The primary outcome for this post hoc analysis was the change in weight from baseline to last study visit. We conducted an 'on-treatment' analysis of patients with at least one follow-up visit on study drug (123 on liraglutide and 124 on placebo). The median age was 61 years, 21% were female, and 69% of patients had New York Heart Association functional Class III or IV symptoms. The median ejection fraction was 25% (25th, 75th percentile 19-32%). Liraglutide use was associated with a significant weight reduction [liraglutide -1.00 lbs vs. placebo 2.00 lbs; treatment difference -4.10 lbs; 95% confidence interval (CI) -7.94, -0.25; P = 0.0367; percentage treatment difference -2.07%, 95% CI -3.86, -0.28; P = 0.0237]. Similar results were seen after multivariable adjustments. Liraglutide also significantly reduced triglyceride levels (liraglutide 7.5 mg/dL vs. placebo 12.0 mg/dL; treatment difference -33.1 mg/dL; 95% CI -60.7, -5.6; P = 0.019)., Conclusions: Liraglutide is an efficacious weight loss agent in patients with HFrEF. These findings will require further exploration in a well-powered cardiovascular outcomes trial., (© 2018 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology.)

Objective: The epidemiology of heart failure (HF) is changing. This study aimed to describe questions that arise during the routine care of HF patients that are unanswered by the current literature and describe how the type and focus of these questions has changed over time., Methods: Investigators from the National Heart, Lung, and Blood Institute-sponsored Heart Failure Apprentice Network collected and categorized questions from 5 academic hospitals over 12 months. A total of 174 unanswered questions were collected and analyzed., Results: Compared with 2004, there were more unanswered questions about "whether" to use therapies and fewer about "how" to use therapies. There were fewer questions about what therapeutic targets, therapy adjustment, and combination therapies. There were more questions about whether or how to stop therapies and how to add therapies back. Newly prominent topics, not observed in 2004, including novel therapeutics, refractory ventricular tachycardia, right heart failure, and nutrition/frailty, accounted for 24% of questions., Conclusions: Compared with 2004, there are fewer unanswered questions about how to use, adjust, and combine therapies. There were more unanswered questions about whether and how to stop therapies. Almost 25% of unanswered questions dealt with topics indicative of more advanced disease which were not observed in 2004., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Objectives: The mechanism(s) for septic cardiomyopathy in humans is not known. To address this, we measured messenger RNA alterations in hearts from patients who died from systemic sepsis, in comparison to changed messenger RNA expression in nonfailing and failing human hearts., Design: Identification of genes with altered abundance in septic cardiomyopathy, ischemic heart disease, or dilated cardiomyopathy, in comparison to nonfailing hearts., Setting: ICUs at Barnes-Jewish Hospital, St. Louis, MO., Patients: Twenty sepsis patients, 11 ischemic heart disease, nine dilated cardiomyopathy, and 11 nonfailing donors., Interventions: None other than those performed as part of patient care., Measurements and Main Results: Messenger RNA expression levels for 198 mitochondrially localized energy production components, including Krebs cycle and electron transport genes, decreased by 43% ± 5% (mean ± SD). Messenger RNAs for nine genes responsible for sarcomere contraction and excitation-contraction coupling decreased by 43% ± 4% in septic hearts. Surprisingly, the alterations in messenger RNA levels in septic cardiomyopathy were both distinct from and more profound than changes in messenger RNA levels in the hearts of patients with end-stage heart failure., Conclusions: The expression profile of messenger RNAs in the heart of septic patients reveals striking decreases in expression levels of messenger RNAs that encode proteins involved in cardiac energy production and cardiac contractility and is distinct from that observed in patients with heart failure. Although speculative, the global nature of the decreases in messenger RNA expression for genes involved in cardiac energy production and contractility suggests that these changes may represent a short-term adaptive response of the heart in response to acute change in cardiovascular homeostasis.

Left ventricular noncompaction (LVNC) may result in systolic left ventricular (LV) failure resulting in the need for heart transplantation. LV assist devices (LVAD) have been used to bridge these patients to transplantation; however, the extensive trabeculations found in these patients predispose them to thromboembolic events and pump thrombosis. We describe a patient with LVNC in whom an aggressive surgical approach was used to debride the LV cavity of trabeculations to successfully implant an LVAD., (© 2017 Wiley Periodicals, Inc.)

Objectives: This study evaluated the Heartmate Risk Score (HMRS) and its potential benefits in clinical practice., Background: The HMRS has been shown to correlate with mortality in the cohort of patients enrolled in the Heartmate II trials, but its validity in unselected, "real world" populations remains unclear., Methods: This study identified a cohort of 269 consecutive patients who received a Heartmate II left ventricular assist device at our institution, the Barnes-Jewish Hospital in St. Louis, Missouri, between June 2005 and June 2013. Ninety-day and 2-year mortality rates, as well as frequency of several morbid events, were compared by retrospectively assigned HMRS category groups. The analysis was repeated within the subgroup of INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) class 1 patients., Results: Receiver operating curve analysis showed that the HMRS correlated with 90-day mortality with an area under the curve of 0.70. Stratification in low, mid, and high HMRS groups identified patients with increasing hazard of 90-day mortality, increasing long-term mortality, increasing rate of gastrointestinal bleeding events, and increasing median number of days spent in the hospital in the first year post implant. Within INTERMACS class 1 patients, those in the highest HMRS group were found to have a relative risk of 90-day mortality 5.7 times higher than those in the lowest HMRS group (39.1% vs. 6.9%, p = 0.029)., Conclusions: HMRS is a valid clinical tool to stratify risk of morbidity and mortality after implant of Heartmate II devices in unselected patients and can be used to predict short-term mortality risk in INTERMACS class 1 patients., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: There is uncertain evidence of effectiveness of 5-aminosalicylates (5-ASA) to induce and maintain response and remission of active Crohn's disease (CD), and weak evidence to support their use in post-operative CD., Aim: To assess the frequency and determinants of 5-ASA use in CD patients and to evaluate the physicians' perception of clinical response and side effects to 5-ASA., Methods: Data from the Swiss Inflammatory Bowel Disease Cohort, which collects data since 2006 on a large sample of IBD patients, were analysed. Information from questionnaires regarding utilisation of treatments and perception of response to 5-ASA were evaluated. Logistic regression modelling was performed to identify factors associated with 5-ASA use., Results: Of 1420 CD patients, 835 (59%) were ever treated with 5-ASA from diagnosis to latest follow-up. Disease duration >10 years and colonic location were both significantly associated with 5-ASA use. 5-ASA treatment was judged to be successful in 46% (378/825) of treatment episodes (physician global assessment). Side effects prompting stop of therapy were found in 12% (98/825) episodes in which 5-ASA had been stopped., Conclusions: 5-Aminosalicylates were frequently prescribed in patients with Crohn's disease in the Swiss IBD cohort. This observation stands in contrast to the scientific evidence demonstrating a very limited role of 5-ASA compounds in the treatment of Crohn's disease., (© 2014 John Wiley & Sons Ltd.)

Purpose: Spine surgery rates are increasing worldwide. Treatment failures are often attributed to poor patient selection and inappropriate treatment, but for many spinal disorders there is little consensus on the precise indications for surgery. With an aging population, more patients with lumbar degenerative spondylolisthesis (LDS) will present for surgery. The aim of this study was to develop criteria for the appropriateness of surgery in symptomatic LDS., Methods: A systematic review was carried out to summarize the current level of evidence for the treatment of LDS. Clinical scenarios were generated comprising combinations of signs and symptoms in LDS and other relevant variables. Based on the systematic review and their own clinical experience, twelve multidisciplinary international experts rated each scenario on a 9-point scale (1 highly inappropriate, 9 highly appropriate) with respect to performing decompression only, fusion, and instrumented fusion. Surgery for each theoretical scenario was classified as appropriate, inappropriate, or uncertain based on the median ratings and disagreement in the ratings., Results: 744 hypothetical scenarios were generated; overall, surgery (of some type) was rated appropriate in 27%, uncertain in 41% and inappropriate in 31%. Frank panel disagreement was low (7% scenarios). Face validity was shown by the logical relationship between each variable's subcategories and the appropriateness ratings, e.g., no/mild disability had a mean appropriateness rating of 2.3 ± 1.5, whereas the rating for moderate disability was 5.0 ± 1.6 and for severe disability, 6.6 ± 1.6. Similarly, the average rating for no/minimal neurological abnormality was 2.3 ± 1.5, increasing to 4.3 ± 2.4 for moderate and 5.9 ± 1.7 for severe abnormality. The three variables most likely (p < 0.0001) to be components of scenarios rated "appropriate" were: severe disability, no yellow flags, and severe neurological deficit., Conclusion: This is the first study to report criteria for determining candidacy for surgery in LDS developed by a multidisciplinary international panel using a validated method (RAM). The panel ratings followed logical clinical rationale, indicating good face validity. The work refines clinical classification and the phenotype of degenerative spondylolisthesis. The predictive validity of the criteria should be evaluated prospectively to examine whether patients treated "appropriately" have better clinical outcomes.

Background: The RELAX (Phosphodiesterase-5 Inhibition to Improve Clinical Status and Exercise Capacity in Heart Failure with Preserved Ejection Fraction) study was a multicenter, randomized trial of sildenafil versus placebo in heart failure with preserved ejection fraction (HFpEF) with rigorous entry criteria and extensive phenotypic characterization of participants., Objectives: The aim of this study was to characterize clinical features, exercise capacity, and outcomes in patients with HFpEF with or without diabetes and gain insight into contributing pathophysiological mechanisms., Methods: The RELAX study enrolled 216 stable outpatients with heart failure, an ejection fraction ≥ 50%, increased natriuretic peptide or intracardiac pressures, and reduced exercise capacity. Prospectively collected data included echocardiography, cardiac magnetic resonance, a comprehensive biomarker panel, exercise testing, and clinical events over 6 months., Results: Compared with nondiabetic patients (n = 123), diabetic HFpEF patients (n = 93) were younger, more obese, and more often male and had a higher prevalence of hypertension, renal dysfunction, pulmonary disease, and vascular disease (p < 0.05 for all). Uric acid, C-reactive protein, galectin-3, carboxy-terminal telopeptide of collagen type I, and endothelin-1 levels were higher in diabetic patients (p < 0.05 for all). Diabetic patients had more ventricular hypertrophy, but systolic and diastolic ventricular function parameters were similar in diabetic and nondiabetic patients except for a trend toward higher filling pressures (E/e') in diabetic patients. Diabetic patients had worse maximal (peak oxygen uptake) and submaximal (6-min walk distance) exercise capacity (p < 0.01 for both). Diabetic patients were more likely to have been hospitalized for heart failure in the year before study entry (47% vs. 28%, p = 0.004) and had a higher incidence of cardiac or renal hospitalization at 6 months after enrollment (23.7% vs. 4.9%, p < 0.001)., Conclusions: HFpEF patients with diabetes are at increased risk of hospitalization and have reduced exercise capacity. Multimorbidity, impaired chronotropic reserve, left ventricular hypertrophy, and activation of inflammatory, pro-oxidative, vasoconstrictor, and profibrotic pathways may contribute to adverse outcomes in HFpEF patients with diabetes. (Evaluating the Effectiveness of Sildenafil at Improving Health Outcomes and Exercise Ability in People With Diastolic Heart Failure [The RELAX Study]; NCT00763867)., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Purpose: This systematic review summarises the literature on patient selection, decision-making, effectiveness and outcomes in the surgical treatment of lumbar degenerative spondylolisthesis (LDS)., Introduction: In daily practice, decision-making in the treatment of LDS is challenging. There is little consensus on either the precise indications or prognostic factors for any specific therapy (operative or non-operative)., Methods: We searched for LDS trials published between 01.01.1990 and 16.11.2011 in Medline, Embase, Cochrane Library and Cinahl. Two independent reviewers selected studies according to the inclusion criteria. Data were then extracted by two of the authors. Quality assessment was performed using the Downs and Black list for the clinical trials/studies and AMSTAR for the reviews., Data Synthesis: 21 papers met the inclusion criteria (2 studies comprising both a RCT and a concurrent observational analysis, 1 RCT, 6 prospective studies, 8 retrospective studies, 3 reviews, 1 review guideline). The quality of the clinical studies was on average "fair" [mean score 15.6 points (range 10-19) out of 24 points (Downs and Black)]. The quality of the reviews ranged from 1 to 7 out of 11 points with an average of 5 points (AMSTAR). The study outcomes could not be subject to meta-analysis due to heterogeneity of study design and variable measure used., Conclusions: Despite there being many articles describing and/or comparing different surgical options for LDS, there was insufficient evidence to draw conclusions concerning clear indications for specific types of surgical treatment, predictors of outcome or complication rates. There remains a need to establish a decision-making tool to facilitate daily clinical practice and to assure appropriate treatment for patients with LDS.

Background: About 30-50% of patients with Crohn's disease (CD) develop fistulae, implying significant disease burden and complicated clinical management., Aim: To assess appropriate use of therapy for fistulizing CD patients enrolled in the Swiss Inflammatory Bowel Disease Cohort using criteria developed by the European Panel on the Appropriateness of Crohn's disease Therapy., Methods: Specific questionnaires were used to gather information on disease and its management. We assessed appropriateness of therapy at enrolment for adult CD patients with one or several fistulae., Results: Two hundred and eighty-eight CD patients had fistulizing disease, of which 80% had complex fistulae and 32% currently had active draining fistulae. Mean age (s.d.) at diagnosis was 27 years (11), 51% males. Of the patients, 78% were judged as having globally an appropriate therapy, which was more often given for complex fistulae (87%) than for simple fistulae (67%). Antibiotics, azathioprine/MP, methotrexate and conservative surgery were almost always appropriate. Anti-tumor necrosis factor α was considered globally appropriate (91%), although most often with an uncertain indication. The 5ASA compounds, steroids and aggressive surgery were most often inappropriate (84%, 58% and 86% respectively)., Conclusions: Formal appropriateness criteria for CD therapy were applied to a national cohort of IBD patients. For more than three-quarters of the patients with fistulizing CD, therapy was globally appropriate., (© 2010 Blackwell Publishing Ltd.)

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.

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.

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.

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.

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.

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.

Background: Variations in colonoscopy practice exist, which may be related to healthcare quality., Aims: To determine factors associated with three performance indicators of colonoscopy: complete colonoscopy, adenomatous polyp diagnosis, and duration., Patients: Consecutive patients referred for colonoscopy from 21 centres in 11 countries., Methods: This prospective observational study used multiple variable regression analyses to identify determinants of the quality indicators., Results: Six thousand and four patients were included in the study. Patients from private, open-access centres (odds ratio: 3.17, 95% confidence interval: 1.87-5.38) were more likely to have a complete colonoscopy than patients from public, gatekeeper centres. Patients from centres where over 50% of the endoscopists were of senior rank were roughly twice as likely to have an adenoma diagnosed, and longer average withdrawal duration (odds ratio: 1.08, 95% confidence interval: 1.07-1.09) was associated with more frequent adenoma diagnoses. Patients who had difficulty during colonoscopy had longer durations to caecum (time ratio: 2.87, 95% confidence interval: 2.72-3.01) and withdrawal durations (time ratio: 1.26, 95% confidence interval: 1.18-1.33) than patients who had no difficulties., Conclusions: Multiple factors have been identified as being associated with key quality indicators. The non-modifiable factors permit the identification of patients who may be at greater risk of not having quality colonoscopy, while changes to the modifiable factors may help improve the quality of colonoscopy.

Objective: To examine the appropriateness and necessity of colonoscopy across Europe., Design: Prospective observational study., Setting: A total of 21 gastrointestinal centers from 11 countries., Participants: Consecutive patients referred for colonoscopy at each center., Intervention: Appropriateness criteria developed by the European Panel on the Appropriateness of Gastrointestinal Endoscopy, using the RAND appropriateness method, were used to assess the appropriateness of colonoscopy., Main Outcome Measure: Appropriateness of colonoscopy., Results: A total of 5213 of 6004 (86.8%) patients who underwent diagnostic colonoscopy and had an appropriateness rating were included in this study. According to the criteria, 20, 26, 27, or 27% of colonoscopies were judged to be necessary, appropriate, uncertain, or inappropriate, respectively. Older patients and those with a major illness were more likely to have an appropriate or necessary indication for colonoscopy as compared to healthy patients or patients who were 45-54 years old. As compared to screening patients, patients who underwent colonoscopy for iron-deficiency anemia [OR: 30.84, 95% CI: 19.79-48.06] or change in bowel habits [OR: 3.69, 95% CI: 2.74-4.96] were more likely to have an appropriate or necessary indication, whereas patients who underwent colonoscopy for abdominal pain [OR: 0.64, 95% CI: 0.49-0.83] or chronic diarrhea [OR: 0.54, 95% CI: 0.40-0.75] were less likely to have an appropriate or necessary indication., Conclusions: This study identified significant proportions of inappropriate colonoscopies. Prospective use of the criteria by physicians referring for or performing colonoscopies may improve appropriateness and quality of care, especially in younger patients and in patients with nonspecific symptoms.

A nationwide investigation was conducted in Switzerland to establish the exposure of the population by medical x rays and update the results of the 1998 survey. Both the frequency and the dose variations were studied in order to determine the change in the collective dose. The frequency study addressed 206 general practitioners (GPs), 30 hospitals, and 10 private radiology institutes. Except for the latter, the response rate was very satisfactory. The dose study relied on the assessment of the speed class of the screen-film combinations used by the GPs as well as the results of two separate studies dedicated to fluoroscopy and CT. The investigation showed that the total number of all medical x-ray examinations performed by GPs registered a 1% decrease between 1998 and 2003, and that the sensitivities of the film-screen combinations registered a shift towards higher values, leading to a reduction of the dose delivered by a GP of the order of 20%. The study indicated also that the total number of all x-ray examinations performed in hospitals increased by 4%, with a slight increase of radiographies by 1% but significant decrease of examinations involving fluoroscopy (39%), and a 70% increase for CT examinations. Concerning the doses, the investigation of a selection of examinations involving fluoroscopy showed a significant increase of the kerma-area product (KAP) per procedure. For CT the study showed an increase of the dose-length product (DLP) per procedure for skull and abdomen examinations, and a decrease for chest examination. Both changes in the frequency and the effective dose per examination led to a 20% increase in the total collective dose.

The age of the patient is of prime importance when assessing the radiological risk to patients due to medical X-ray exposures and the total detriment to the population due to radiodiagnostics. In order to take into account the age-specific radiosensitivity, three age groups are considered: children, adults and the elderly. In this work, the relative number of examinations carried out on paediatric and geriatric patients is established, compared with adult patients, for radiodiagnostics as a whole, for dental and medical radiology, for 8 radiological modalities as well as for 40 types of X-ray examinations. The relative numbers of X-ray examinations are determined based on the corresponding age distributions of patients and that of the general population. Two broad groups of X-ray examinations may be defined. Group A comprises conventional radiography, fluoroscopy and computed tomography; for this group a paediatric patient undergoes half the number of examinations as that of an adult, and a geriatric patient undergoes 2.5 times more. Group B comprises angiography and interventional procedures; for this group a paediatric patient undergoes a one-fourth of the number of examinations carried out on an adult, and a geriatric patient undergoes five times more.

Purpose: This study analyzes CT examinations in Switzerland., Materials and Methods: Using different sources (administrative data on the equipment, a 1998 nationwide inquiry into practices, and data provided by the Swiss University Hospitals of Basel, Zurich, and Lausanne), we determined the frequency of CT examinations (hospitals and private radiologists) in 1998 according to different descriptive variables and studied the progression in CT use over time., Results: CT scanners increased by 7% between 1998 and 2004. The average annual number of CT examinations in 1998 was 46.3/1000 population, 3.4% of all radiological examinations in Switzerland in 1997-1998. The most frequent examination was CT of the skull (24%), while private radiology institutes perform more CTs of the spine. More CT examinations were performed for men than for women (sex ratio M/F=1.17). The average annual increase in CT in Swiss hospitals varied from 8% for Basel to 18% for Lausanne. Finally, the proportion of pediatric examinations was 5%; their numbers appear to be stabilizing., Conclusion: There is a significant increase in CT examinations. It is hoped that our study will heighten awareness among doctors of CT examinations in order to optimize their use.

Background and Study Aims: Sedation and monitoring practice during colonoscopy varies between centers and over time. Knowledge of current practice is needed to ensure quality of care and help focus future research. The objective of this study was to examine sedation and monitoring practice in endoscopy centers internationally., Patients and Methods: This observational study included consecutive patients referred for colonoscopy at 21 centers in 11 countries. Endoscopists reported sedation and monitoring practice, using a standard questionnaire for each patient., Results: 6004 patients were included in this study, of whom 53 % received conscious/moderate sedation during colonoscopy, 30 % received deep sedation, and 17 % received no sedation. Sedation agents most commonly used were midazolam (47 %) and opioids (33 %). Pulse oximetry was done during colonoscopy in 77 % of patients, blood pressure monitoring in 34 %, and electrocardiography in 24 %. Pulse oximetry was most commonly used for moderately sedated patients, while blood pressure monitoring and electrocardiography were used predominantly for deeply sedated patients. Sedation and monitoring use ranged from 0 % to 100 % between centers. Oxygen desaturation (

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., (Copyright (c) 2006 S. Karger AG, Basel.)

Background and Study Aim: Little is known about how gastroenterologists perceive the appropriateness of colonoscopies they perform. The objective of this study was to compare the appropriateness and necessity of colonoscopies as assessed by an expert panel and by the gastroenterologists performing the colonoscopies., Methods: This observational study included 21 centers in 11 countries. Patients referred for colonoscopy were consecutively included. Appropriateness and necessity of colonoscopies were independently rated on a 9-point scale by the gastroenterologists performing them and by an expert panel using a validated method (RAND). The differences between the ratings from the two groups were examined., Results: 6004 patients were included in the study. Comparisons of ratings were possible for 5381 (89.6 %) patients. The gastroenterologists' mean appropriateness rating was 7.2 +/- 1.7, and the panel's mean appropriateness rating was 5.4 +/- 2.3 ( P < 0.001). The percentages of indications rated inappropriate, uncertain, appropriate, and necessary were 4.1 %, 23.8 %, 14.2 %, and 58.0 % for the gastroenterologists and 27.2 %, 26.7 %, 25.0 %, and 21.1 % for the panel, respectively. Agreement between the two groups' ratings was poor (28.8 %, kappa = 0.11). Differences between the two groups' ratings decreased with increasing patient age, decreasing health status, and decreasing expertise level of the referring physician. However, the gastroenterologists produced consistently higher ratings., Conclusions: Compared with an expert panel, gastroenterologists tend to overestimate the appropriateness of colonoscopies they perform. Except for well-delineated reasons, participating gastroenterologists weighed patient characteristics differently from the panel when judging appropriateness. Ways to increase the prospective use of appropriateness criteria in order to improve appropriateness and reduce overuse of colonoscopies should be examined further.

(13)C labeling was used to enhance the sensitivity of (13)C solid-state NMR to study the effect of tabletting on the polymorphism of a steroidal drug. The steroidal drug Org OD 14 was (13)C labeled and formulated into tablets containing only 0.5-2.5% active ingredient. The tablets were subsequently studied by solid-state (13)C CPMAS NMR. The crystalline form present in tablets could readily be analyzed in tablets. No change in crystalline form was observed as a result of formulation or in subsequent stability studies. Solid-state NMR in combination with (13)C labeling can, in suitable cases, be used as a strategy to study the effect of formulation on the polymorphism of low dose drugs., (Copyright 2004 Wiley-Liss, Inc.)

Objectives: To measure the frequencies of dental radiological examinations in Switzerland and to determine the associated collective radiation doses., Methods: To evaluate the frequencies, a sample of 376 dental practitioners and other institutions performing dental radiology were requested to fill in questionnaires designed to measure, amongst others, frequencies of dental radiodiagnoses according to type of examination, patient age and gender, dental specialty and type of surgery. The associated collective radiation doses were determined by multiplying the relevant frequencies with dose estimates obtained from recent measurements and calculations., Results: The total number of dental examinations performed in Switzerland in 1998 was 4.1 million (581 per 1000 population). Periapical, bitewing and panoramic radiographs were the most frequent types of dental examinations. The collective dose associated with dental radiology was 71 person.Sv. This amounts to an annual average effective dose to the population of 10 muSv per caput, which is in agreement with the figures reported for countries of similar healthcare level. Various features such as the age distribution of the radiographed patients, the forms of collimators used, film consumption and the use of digital imaging systems are presented., Conclusions: Several recommendations for dose reduction are made. These include the re-evaluation of the patterns and justification for prescribing some particular types of dental examinations as well as the avoidance of unnecessary irradiation by the use of rectangular collimation and high sensitivity F-speed films.

Objective: The specificity of a University Hospital Centre is usually assessed from its teaching and research capacity. The EPAGE survey, an instrument used to help decision making available on the Internet, permitted us to compare the prescription of a routine exploration, gastrointestinal endoscopy, between the University Hospital Center in Clermont-Ferrand and the Hospital Centre in Moulins. The aim was to demonstrate the differences in daily practice between these two geographically close hospital centres and hence to underline the specificity of a University Hospital Centre that is not taken into account in the financing systems of such hospitals. Method The data collected were taken from the EPAGE trial, a prospective mutlicentre study that included 21 European and Canadian centres. Data was collected from the University Hospital centre in Clermont-Ferrand over two periods: from December 2000 to March 2001, then from December 2001 to February 2002, and from the Hospital Centre in Moulins, from December 2000 to the end of November 2001. For this Article, only the patients' characteristics, indications for gastrointestinal endoscopy and opportunity rate were analysed. Comparison of patients' categories from the 2 centres was conducted according to their DRG (diagnostic related group) (homogeneous patient group) classification, thus allowing calculation of the mean of the SIA (synthetic index of activity) points in the two centres., Results: 221 cases of gastrointestinal endoscopy performed in the University Hospital centre and 292 in the Hospital Centre were included in the survey. No statistically significant difference was found in the reasons motivating a gastrointestinal endoscopy, with regard to the indications listed on the EPAGE website. There were 18% of unlisted indications in the University Hospital Centre versus 4.8% in the Hospital Centre (p<1.10-6). Using the DRG nomenclature, calculation of the mean SIA points at the University Hospital Centre per patient was of 1161 versus 1147: non significant deviation of 1.2% in favour of the University Hospital Centre., Discussion: - Conclusion The difference in reasons motivating a gastrointestinal endoscopy found between the two centres concerned rare, complex or innovating situations. This illustrates the role of a Regional Reference University Hospital Centre, an aspect clearly underestimated when measuring mixed cases according to the HPG. Study of the financing and/or information systems is warranted and might resolve the apparent underestimation of the current financing system.

A patient-oriented survey was conducted in Switzerland with the aim to establishing the distribution of medical X-ray examinations among the population. A sample of 1235 people aged between 15 and 74 y (589 males and 637 females) was contacted. The participants were asked to give the number of medical X-ray examinations performed during the previous 12 months. Three-fourths of the sample did not undergo any medical X-ray examination during a 12 month-period, and 10% of the population underwent more than 1 medical X-ray examination in a year. These results were independent of the geographic region. The age distributions of the participants who did not undergo any medical X-ray examination and those who underwent one medical X-ray examination were similar. On the other hand, the age distribution of the participants who underwent more than one medical X-ray examination was characterised by a higher contribution from the elderly., (Copyright 2004 Oxford University Press)

The use in Switzerland of three chest X-ray imaging modalities is studied. The frequency and dosimetric aspects associated with chest radiography, chest CT, and photofluorography are investigated and the Swiss figures are compared with those of other countries. The frequencies are established by means of a nationwide survey performed in 1998, whereas the doses are determined by modelling, based on the technical parameters of the examinations. The annual frequencies of chest radiography, chest CT, and photofluorography are 201, 7, and 7 per thousand population, respectively. The standard effective doses related to these three types of examinations are 0.057, 9, and 0.13 mSv, respectively. The collective dose associated with chest X-ray imaging amounts to 606 man.Sv, representing 8.5% of the total collective dose due to diagnostic and interventional radiology. The geographic and seasonal variations, as well as the distribution with the medical specialty and with the age of the patient, are established. The Swiss results compare well with the average data published in the literature for other countries of similar health care level. Chest radiography shows a significant decrease with time. It dropped by a factor of 2 in 20 years. The conformity of the indication of chest X-ray modalities with referral guidelines is also investigated.

The effective dose delivered to the patient was determined, by modeling, for 257 types of examinations covering the different modalities of diagnostic and interventional radiology. The basic operational dosimetric quantities considered were obtained from the parameters of the examinations on the basis of dosimetric models. These models required a precise characterization of each examination. The operational dosimetric quantities were converted into doses to organs and effective doses using appropriate conversion factors. The determination of the collective effective dose to the Swiss population requires a number of corrections to account for the variability of several parameters: sensitivity of the detection system, age, gender, and build of the patient. The use of various dosimetric models is illustrated in this paper for a limited number of examination types covering the different radiological modalities, for which the established typical effective doses are given. With regard to individual doses, the study indicated that the average effective doses per type of examination can be classified into three levels: (a) the weakly irradiating examinations (less than 0.1 mSv), which represent 78% of the examinations and 4% of the collective dose, (b) the moderately irradiating examinations (between 0.1 mSv and 10 mSv), which represent 21% of the examinations and 72% of the collective dose, (c) the strongly irradiating examinations (more than 10 mSv), which represent 1% of the examinations and 24% of the collective dose.

A nation-wide survey on radiation doses in diagnostic and interventional radiology was conducted in Switzerland in 1998 aiming at establishing their collective radiological impact on the Swiss population. The study consisted on the one hand of surveying the frequency of more than 250 types of examinations, covering conventional radiology, mammography, fluoroscopy, angiography, interventional radiology, CT, bone densitometry, conventional tomography and dental radiology. On the other hand, for each type of examination the associated patient dose was established by modeling. The results of this study show that about 9.5 million diagnostic and interventional examinations are performed annually in Switzerland (1.34 per caput) and that the associated annual collective dose is of the order of 7100 person.Sv (1.0 mSv per caput). Switzerland is similar to other European countries in terms of the frequency of examinations and the collective dose.

Background and Study Aims: Appropriateness of use of colonoscopy is an important issue in health care in the quest to improve quality of care while at the same time containing costs. This prospective study examined whether detailed and explicit appropriateness criteria significantly improve the diagnostic yield of colonoscopy., Patients and Methods: Consecutive patients referred for diagnostic colonoscopy at five centers (one university hospital and its outpatient department, two district hospitals, and two gastroenterology practices) were prospectively studied over a 17-month period. The appropriateness of the indications for these colonoscopies was assessed using explicit Swiss criteria developed by the Rand Corporation/University of California at Los Angeles (RAND/UCLA) panel method, and the relationship between appropriateness of use and the presence of clinically relevant endoscopic lesions was analysed., Results: 1188 patients were included in the study. Indications for 1144 (96.3 %) of the colonoscopies could be evaluated using explicit criteria; 64.1 % of the colonoscopies were judged appropriate, 13.3 % uncertain and 22.6 % inappropriate. Significant endoscopic lesions were found in 23.8 % of the colonoscopies. Colonoscopies judged appropriate or uncertain yielded significantly more relevant lesions than did those judged to be inappropriate (25.6 % vs. 17.4 %; P = 0.007). Of 51 colon cancers, all but one were found in colonoscopies judged to be appropriate or uncertain. In a multivariate analysis, the diagnostic yield of colonoscopy was significantly influenced by appropriateness, patient gender and treatment setting., Conclusions: The use of detailed and explicit appropriateness criteria for colonoscopy significantly enhances the identification of relevant lesions and in particular of colon cancer. The use of such criteria could therefore improve patient selection for colonoscopy and thus contribute to efforts aimed at enhancing the quality and efficiency of care.

Physicians must insure that care provided--whether it be preventive, diagnostic, therapeutic of palliative--is appropriate. Confronted with the swift development of medical progress and the tremendous quantity and uneven quality of available information on appropriateness of care, it is important to determine optimal strategies for identifying necessary, relevant and valid information in this respect. Medical care is considered appropriate if the expected benefits to the patient outweigh the potential risks. The ideal source of information concerning appropriateness of care stems from rigorously conducted, randomized, controlled trials and from systematic reviews of the literature, such as those prepared by the Cochrane Collaboration. Concerning treatment of low back pain, recent years have witnessed several groups active in preparing such rigorous systematic reviews. Different sources of information on appropriateness of care for back pain are presented in this article. Unfortunately, many reviews underline the absence of evidence for the effectiveness of most treatments now used in the treatment of low back pain. On the other hand, absence of proof of effectiveness, and, as often in medicine, elements other than the quality of evidence must enter into the decision to use or not to use various treatments. But this should not keep us from pursuing rigorous clinic research to improve the scientific basis of care provided to our patients suffering from low back pain.

Objectives: The aim of this study was to assess the still controversial role of treatment of Helicobacter pylori (H. pylori) infection in patients with nonulcer dyspepsia., Methods: We conducted a double-blind, randomized, placebo-controlled, multicenter trial comparing the efficacy of 7 days of eradication treatment (lansoprazole 15 mg b.i.d., amoxicillin I g b.i.d., and clarithromycin 500 mg b.i.d.) with a control treatment (lansoprazole 15 mg b.i.d. and placebo) in H. pylori-infected patients with nonulcer dyspepsia. 13C breath tests were performed at baseline and during follow-up. We assessed patient symptoms, health status (based on the SF-12 questionnaire), patient satisfaction, drug consumption, health care consultation behavior, and absenteeism related to dyspepsia over a 1-yr period., Results: A total of 74 patients randomized to eradication treatment and 70 patients randomized to placebo were compared. The rate of eradication of H. pylori infection was 75% in the active treatment group and 4% in the placebo group (p < 0.005). The symptom score improved to a similar extent in the group receiving active treatment (-4.0; 95% CI = -5.0 to -3.0) and placebo (-3.6; 95% CI = -4.5 to -2.7). Treatment response was not related to the severity or duration of initial symptoms or to the severity of gastritis on histology. Quality of life scores were comparable at 12 months. There was no significant difference in dyspepsia-related absenteeism or satisfaction with management of NUD. Patients receiving active treatment were more likely not to have had to use any dyspepsia treatment over the 12 months (60.8% vs 44.3%; p = 0.047)., Conclusions: This study did not demonstrate any substantial benefit of curing H. pylori infection in patients with nonulcer dyspepsia. The study adds further evidence that H. pylori is not the main pathogenetic or therapeutic target in these patients.

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.

Degradation of ethinyl estradiol (EE2) by nitrifying activated sludge was studied with micro-organisms grown in a reactor with feedback of sludge fed with only a mineral salts medium containing ammonium as the sole energy source. Ammonium was oxidised by this sludge at a rate of 50 mg NH4+ g(-1) DW h(-1). This activated sludge was also capable of degrading EE2 at a maximum rate of 1 microg g(-1) DW h(-1). Using sludge with an insignificant nitrifying capacity of 1 mg NH4+ g(-1) DW h(-1), no degradation of EE2 was detected. Oxidation of EE2 by nitrifying sludge resulted in the formation of hydrophilic compounds, which were not further identified. Most probably degradation by nitrifying sludge results in a loss of estrogenic activity, as hydroxylated derivatives of EE2 are known to have a substantially lower pharmacological activity than EE2.

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).

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.