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W Scott Harmsen

Publications and source records attributed to W Scott Harmsen.

At least 19 recordsLinked to original sources
PubMed2007

Risk factors for colorectal neoplasia in inflammatory bowel disease: a nested case-control study from Copenhagen county, Denmark and Olmsted county, Minnesota.

OBJECTIVES: Population-based data on risk factors and protective factors for colorectal dysplasia and cancer in patients with inflammatory bowel disease (IBD) are sparse. We conducted a nested case-control study of such factors in two well-described IBD cohorts from Copenhagen County, Denmark and Olmsted County, Minnesota. METHODS: Forty-three neoplasia cases were matched on six criteria to 1-3 controls (N = 102). Medical records were scrutinized for demographic and clinical data. For each variable, the odds of neoplasia were estimated using conditional logistic regression. RESULTS: Primary sclerosing cholangitis (PSC) (odds ratio [OR] 6.9, 95% confidence interval [CI] 1.2-40), percentage of disease course with clinically active disease (OR [per 5% increase] 1.2, 95% CI 0.996-1.4), and >or=1 yr of continuous symptoms (OR 3.2, 95% CI 1.2-8.6) were associated with neoplasia, whereas a borderline association with median number of small-bowel x-rays (OR 1.3, 95% CI 0.96-1.6) was observed. We did not observe a protective effect of frequency of physician visits (OR 1.4, 95% CI 0.96-2.0), number of colonoscopies (OR 1.4, 95% CI 1.0-2.1), cumulative dose of sulfasalazine (OR [per 1,000 g] 1.1, 95% CI 1.0-1.3) and mesalamine (OR [per 1,000 g] 1.3, 95% CI 0.9-1.9), or partial intestinal resections (OR 1.5, 95% CI 0.3-7.1). CONCLUSIONS: Subgroups of IBD patients-those with PSC, severe long-standing disease, and exposure to x-ray-were at greater risk of colorectal neoplasia. The protective effect of close follow-up, colonoscopy, and treatment with 5-aminosalicylates was questionable.

Adult↗
PubMed2007

Update on the incidence and prevalence of Crohn's disease and ulcerative colitis in Olmsted County, Minnesota, 1940-2000.

BACKGROUND: We previously reported that the prevalence of Crohn's disease (CD) and ulcerative colitis (UC) in Olmsted County, Minnesota, had risen significantly between 1940 and 1993. We sought to update the incidence and prevalence of these conditions in our region through 2000. METHODS: The Rochester Epidemiology Project allows population-based studies of disease in county residents. CD and UC were defined by previously used criteria. County residents newly diagnosed between 1990 and 2000 were identified as incidence cases, and persons with these conditions alive and residing in the county on January 1, 2001, were identified as prevalence cases. All rates were adjusted to 2000 US Census figures for whites. RESULTS: In 1990-2000 the adjusted annual incidence rates for UC and CD were 8.8 cases per 100,000 (95% confidence interval [CI], 7.2-10.5) and 7.9 per 100,000 (95% CI, 6.3-9.5), respectively, not significantly different from rates observed in 1970-1979. On January 1, 2001, there were 220 residents with CD, for an adjusted prevalence of 174 per 100,000 (95% CI, 151-197), and 269 residents with UC, for an adjusted prevalence of 214 per 100,000 (95% CI, 188-240). CONCLUSION: Although incidence rates of CD and UC increased after 1940, they have remained stable over the past 30 years. Since 1991 the prevalence of UC decreased by 7%, and the prevalence of CD increased about 31%. Extrapolating these figures to US Census data, there were approximately 1.1 million people with inflammatory bowel disease in the US in 2000.

Adolescent↗
PubMed2007

Outcomes of shoulder arthroplasty in Olmsted County, Minnesota: a population-based study.

Most studies on shoulder arthroplasty include a diverse group of patients presenting to a tertiary care center. Little information is available regarding outcomes in a community setting. We reviewed 98 residents (110 shoulders) of Olmsted County, Minnesota who had shoulder arthroplasties from 1976 to 2000. There were 65 total shoulder arthroplasties and 45 humeral head replacements. The most common indications were osteoarthritis for total shoulder arthroplasties (48/65) and acute fracture for hemiarthroplasties (27/45). The Neer ratings were excellent or satisfactory in 92% of total shoulder arthroplasties and 56% of hemiarthroplasties. The 10-year survival rate was 96%. The mean postoperative active forward elevation was greater in patients who had a total shoulder arthroplasty (132 degrees) compared with a hemiarthroplasty (113 degrees), as was external rotation (total shoulder arthroplasties = 58 degrees, humeral head replacements = 38 degrees). The outcomes for total shoulder arthroplasty and hemiarthroplasty compared favorably with outcomes reported in the literature. There was a high rate of satisfactory or excellent results after total shoulder arthroplasty for osteoarthritis. Hemiarthroplasty offered less satisfactory results, most likely related to the use of this procedure for trauma. This information will assist the community surgeon in counseling patients and weighing the risks and benefits of a shoulder arthroplasty.

Adult↗
PubMed2006

The epidemiology of microscopic colitis: a population based study in Olmsted County, Minnesota.

OBJECTIVE: Although the epidemiology of microscopic colitis has been described in Europe, no such data exist from North America. We studied the incidence, prevalence and temporal trends of microscopic colitis in a geographically defined US population. DESIGN AND SETTING: In this population based cohort study, residents of Olmsted County, Minnesota, with a new diagnosis of microscopic colitis, and all who had colon biopsies for evaluation of diarrhoea, between 1 January 1985 and 31 December 2001 were identified. Biopsies were reviewed for confirmation (cases) and to identify missed cases (diarrhoea biopsies). MAIN OUTCOME MEASURES: Incidence rates, age and sex adjusted to the 2000 US white population. Poisson regression assessed the association of calendar period, age and sex with incidence. RESULTS: We identified 130 incident cases for an overall rate of 8.6 cases per 100,000 person-years. There was a significant secular trend, with incidence increasing from 1.1 per 100,000 early in the study to 19.6 per 100,000 by the end (p<0.001). Rates increased with age (p<0.001). By subtype, the incidence was 3.1 per 100,000 for collagenous colitis and 5.5 per 100,000 for lymphocytic colitis. Collagenous colitis was associated with female sex (p<0.001) but lymphocytic colitis was not. Prevalence (per 100,000 persons) on 31 December 2001 was 103.0 (39.3 for collagenous colitis and 63.7 for lymphocytic colitis). CONCLUSIONS: The incidence of microscopic colitis has increased significantly over time, and by the end of the study, the incidence and prevalence were significantly higher than reported previously. Microscopic colitis is associated with older age, and collagenous colitis is associated with female sex.

Adult↗
PubMed2006

Surgical treatment of tumors of the proximal stomach with involvement of the distal esophagus: a 26-year experience with Siewert type III tumors.

OBJECTIVE: A paucity of outcome data exists regarding patients with proximal stomach cancer involving the distal esophagus (Siewert type III tumors). This is especially true with regard to long-term survival rates after surgical intervention. METHODS: Medical records were reviewed of all patients who underwent total gastrectomy and distal esophagectomy with Roux-en-Y esophagojejunostomy for Siewert type III tumors from January 1975 through December 2000. RESULTS: There were 116 patients (93 men and 23 women). The median age was 66 years (range, 22-87 years). Pathologic stage was 0 (carcinoma in situ) in 1 patient, IB in 13 patients, II in 17 patients, IIIA in 34 patients, IIIB in 10 patients, and IV in 41 patients. Complete resection was achieved in 69 (59.5%) patients. Eleven (9.5%) patients were treated with neoadjuvant therapy, 49 (42.2%) received adjuvant therapy, and 6 (5.2%) received intraoperative radiation. Follow-up was complete in 114 (98.3%) patients, ranging from 1 to 281 months (median, 14 months). Operative mortality was 5.2%. Complications occurred in 51 (43.9%) patients. Clinically significant anastomotic leaks occurred in 15 (12.9%) patients. Median hospitalization was 13 days (range, 8-70 days). Median follow-up was 14 months (range, 1-281 months). Overall median survival was 434 days, with 1-, 5-, and 10-year survivals of 56.2%, 19.0%, and 13.5%, respectively. The only factor associated with increased hospital mortality was anastomotic leakage (P = .002). Incomplete resection, increased tumor stage and grade, and splenic involvement significantly worsened long-term survival. CONCLUSIONS: Total gastrectomy and distal esophagectomy for Siewert type III tumors is associated with reasonable mortality and significant morbidity. Although often palliative, surgical intervention can provide long-term survival, especially in patients with completely resected, early-stage, low-grade tumors.

Adenocarcinoma↗
PubMed2006

Risk of intestinal cancer in inflammatory bowel disease: a population-based study from olmsted county, Minnesota.

BACKGROUND & AIMS: The risk for colorectal cancer in Crohn's disease and ulcerative colitis patients from the United States currently is unknown. We estimated the risk for small-bowel and colorectal cancer in a population-based cohort of 692 inflammatory bowel disease patients from Olmsted County, Minnesota, from 1940 to 2001. METHODS: The Rochester Epidemiology Project was used to identify cohort patients with colorectal and small-bowel cancer. The cumulative probability of cancer and standardized incidence ratios (SIR) were estimated using expected rates from Surveillance, Epidemiology, and End Results, white patients from Iowa, from 1973 to 2000, and Olmsted County, from 1980 to 1999. RESULTS: Colorectal cancer was observed in 6 ulcerative colitis patients vs 5.38 expected (SIR, 1.1; 95% confidence interval [CI], 0.4-2.4), but 4 of these occurred among those with extensive colitis or pancolitis (SIR, 2.4; 95% CI, 0.6-6.0). Six Crohn's disease patients (vs 3.2 expected) developed colorectal cancer (SIR, 1.9; 95% CI, 0.7-4.1). Three Crohn's disease patients developed small-bowel cancer vs 0.07 expected (SIR, 40.6; 95% CI, 8.4-118). CONCLUSIONS: The risk for colorectal cancer was not increased among ulcerative colitis patients overall, but appeared to be increased among those with extensive colitis. The colorectal cancer risk was increased slightly among Crohn's disease patients, who also had a 40-fold excess risk for small-bowel cancer.

Adolescent↗
PubMed2006

Predictive and protective factors associated with colorectal cancer in ulcerative colitis: A case-control study.

BACKGROUND & AIMS: Predictive and protective factors associated with colorectal cancer in chronic ulcerative colitis are not well described. Surveillance colonoscopy and 5-aminosalicylic acid therapy may mitigate cancer risk, but there is debate because these variables have not been evaluated in the same study. The presence of postinflammatory pseudopolyps and use of other anti-inflammatory medications may be important variables that influence risk, but data are sparse. METHODS: Variables associated with colorectal cancer were registered in 188 patients with ulcerative colitis-related cancer and matched controls. Conditional logistic regression, adjusted for age at colitis diagnosis and colitis duration, identified a final set of variables independently associated with colorectal cancer. RESULTS: In the final multiple variable model, the most important factors associated with colorectal cancer were a history of pseudopolyps (OR, 2.5; 95% CI: 1.4-4.6), 1 or 2 surveillance colonoscopies (OR, 0.4; 95% CI: 0.2-0.7), smoking (OR, 0.5; 95% CI: 0.2-0.9) and use of corticosteroids (OR, 0.4; 95% CI: 0.2-0.8), aspirin (OR, 0.3; 95% CI: 0.1-0.8), nonsteroidal anti-inflammatory drugs (OR, 0.1; 95% CI: 0.03-0.5), and 5-aminosalicylic acid agents (OR, 0.4; 95% CI: 0.2-0.9), although the latter was not statistically significant after 5 years. Primary sclerosing cholangitis and immunosuppressive use were not statistically significant. CONCLUSIONS: These results suggest that, in a population matched for extent and duration of chronic ulcerative colitis, surveillance colonoscopy and use of anti-inflammatory medications may reduce the risk of colorectal cancer. A history of postinflammatory pseudopolyps appears to be a predictive factor for cancer.

Adolescent↗
PubMed2006

Incidence and prognosis of colorectal dysplasia in inflammatory bowel disease: a population-based study from Olmsted County, Minnesota.

BACKGROUND AND AIMS: The risk, fate, and ideal management of colorectal dysplasia in inflammatory bowel disease (IBD) remain debated. We estimated the incidence, long-term outcome, and risk factors for progression of colorectal dysplasia (adenomas [adenoma-associated lesions or masses (ALMs)], flat dysplasia, and dysplasia-associated lesions or masses [DALMs]) in a population-based IBD cohort from Olmsted County, Minnesota. MATERIALS AND METHODS: The Rochester Epidemiology Project was used to identify cohort patients with colorectal dysplasia. Medical records were reviewed for demographic and clinical characteristics. Histology slides were reviewed by a pathologist blinded to previous pathology reports. The cumulative incidence of dysplasia was estimated, and the association between patient characteristics and recurrence/progression of dysplasia was assessed using proportional hazards regression. RESULTS: Twenty-nine (4%) IBD patients developed flat dysplasia (n = 8), DALMs (n = 1), ALMs in areas of IBD (n = 18), or ALMs outside areas of IBD (n = 2). Among 6 patients with flat low-grade dysplasia (fLGD) who did not undergo colectomy, none progressed during a median of 17.8 (range 6-21) years of observation with a median of 3 (range 0-12) surveillance colonoscopies. Four (22%) patients with ALMs in areas of IBD who did not undergo surgery developed LGD or DALMs. Primary sclerosing cholangitis and dysplasia located proximal to the splenic flexure were significantly associated with risk for recurrence/progression of dysplasia. CONCLUSIONS: This population-based cohort study from Olmsted County, Minnesota did not confirm an increased risk of cancer related to fLGD, whereas 22% of patients with ALMs in areas of IBD developed fLGD or DALMs.

Adenoma↗
PubMed2006

Microscopic colitis is not associated with cholecystectomy or appendectomy.

BACKGROUND: Microscopic colitis is a common cause of chronic watery diarrhea of unknown origin. Some patients develop diarrhea after cholecystectomy, and some patients with microscopic colitis have evidence of bile acid malabsorption. However, the association between cholecystectomy and microscopic colitis has not been studied. A protective effect of appendectomy on the development of ulcerative colitis also has been reported, but its relationship with microscopic colitis has not been studied. The aim of this study was to assess cholecystectomy and appendectomy as potential risk factors for the development of microscopic colitis in a nested case-control study. MATERIALS AND METHODS: Using the Rochester Epidemiology Project, we identified all Olmsted County (Minnesota) residents with an initial diagnosis of microscopic colitis between January 1, 1985, and December 31, 2001. Rates of antecedent cholecystectomy or appendectomy in patients with microscopic colitis were compared with age-, gender-, and calendar year-matched community controls through conditional logistic regression. RESULTS: Microscopic colitis was identified in 130 cases. Cholecystectomy preceded the diagnosis of microscopic colitis in 12 cases (9%) compared with 17 (13%) in the control group (odds ratio [OR] 0.7; 95% CI 0.3-1.5). Appendectomy preceded the diagnosis of microscopic colitis in 39 subjects (30%) compared with 28 (22%) in the control group (OR 1.6; 95% CI 0.9-2.7). Similar results were obtained when the analysis was restricted to microscopic colitis subtype (lymphocytic colitis or collagenous colitis). CONCLUSIONS: In this population-based nested case-control study, no significant association was seen between cholecystectomy or appendectomy and the development of microscopic colitis or its subtypes.

Adult↗
PubMed2006

The Chitranjan Ranawat Award: Long-term survivorship and failure modes of 1000 cemented condylar total knee arthroplasties.

We examined factors affecting survivorship, and reasons for reoperation and revision of a cemented modular condylar total knee arthroplasty (TKA). One thousand and eight consecutive primary cemented cruciate-retaining TKAs performed at one institution were studied. At the time of review, 411 patients (562 knees) had died, 43 patients (45 knees) had their knee components revised or removed, and 47 patients (62 knees) were lost to followup. Mean followup of living patients with their TKA components in situ (244 patients, 331 knees) was 15.7 years. Survivorship at 15 years for revision for any reason, revision for mechanical failure, and revision for aseptic loosening were 95.9%, 97.0%, and 98.8% respectively. Survivorship was poorer among patients aged less than 60. Forty-five knees had components removed or revised; approximately one-third were removed for infection, one-third for aseptic loosening or tibial polyethylene wear, and one-third for other causes. Mechanical implant failures accounted for less than one-half of the reoperations and revisions, while infection and periprosthetic fractures accounted for a substantial portion of revisions and reoperations. Because mechanical arthroplasty failures have become less common, other complications related to arthroplasty have become proportionately more frequent.

Adolescent↗
PubMed2006

A population-based study of the frequency of corticosteroid resistance and dependence in pediatric patients with Crohn's disease and ulcerative colitis.

BACKGROUND: The goal of this study was to examine the 1-year outcome after the first course of systemic corticosteroids in an inception cohort of pediatric patients with inflammatory bowel disease. METHODS: All Olmsted County (Minnesota) residents diagnosed with Crohn's disease (n = 50) or ulcerative colitis (n = 36) before 19 years of age from 1940 to 2001 were identified. Outcomes at 30 days and 1 year after the initial course of corticosteroids were recorded. RESULTS: Twenty-six patients with Crohn's disease (65%) and 14 with ulcerative colitis (44%) were treated with corticosteroids before age 19. Thirty-day outcomes for corticosteroid-treated Crohn's disease were complete remission in 16 (62%), partial remission in 7 (27%), and no response in 3 (12%), with 2 of these patients requiring surgery. Thirty-day outcomes for treated ulcerative colitis were complete remission in 7 (50%), partial remission in 4 (29%), and no response in 3 (21%). One-year outcomes for Crohn's disease were prolonged response in 11 (42%) and corticosteroid dependence in 8 (31%), whereas 7 (27%) were postsurgical. One-year outcomes for ulcerative colitis were prolonged response in 8 (57%) and corticosteroid dependence in 2 (14%), whereas 4 (29%) were postsurgical. CONCLUSIONS: Most pediatric patients with inflammatory bowel disease initially responded to corticosteroids. However, after 1 year, 58% of pediatric patients with Crohn's disease and 43% of pediatric patients with ulcerative colitis either were steroid dependent or required surgery. This finding emphasizes the need for early steroid-sparing medications in pediatric inflammatory bowel disease.

Adolescent↗
PubMed2006

Breast lesions: evaluation with US strain imaging--clinical experience of multiple observers.

PURPOSE: To prospectively determine the accuracy of using an ultrasonographic (US) strain imaging technique known as lesion size comparison to differentiate benign from malignant breast lesions. MATERIALS AND METHODS: Institutional Review Board approval and patient informed consent were obtained for this HIPPA-compliant study. US strain imaging was performed prospectively for 89 breast lesions in 88 patients. Lesions were imaged by using freehand compression and a real-time strain imaging algorithm. Five observers obtained manual measurements of lesion height, width, and area from B-mode and strain images. By using these size measurements, individual observer and group performances were assessed by using the area under the receiver operating characteristic curve (A(z)). The performance of a single size parameter versus that of a combination of size parameters was evaluated by using univariate and multivariate logistic regression. RESULTS: Group A(z) values showed that width ratio and area ratio yielded the best results for differentiating benign and malignant breast lesions, and they were not statistically different from one another (P = .499). For the group, the performance of area and width, which was superior to that of height and aspect ratio, was statistically significant for all cases (P < .011) except for those that compared area with aspect ratio (P = .118). By using a group threshold of 1.04 for width ratio and 1.13 for area ratio, the sensitivity and specificity of the technique were 96% and 21%, respectively, for width and 96% and 24%, respectively, for area. The best observer achieved a sensitivity of 96% and a specificity of 61% by using the area ratio. For all but one observer, combined size parameters did not improve observer performance (P > .258). Significant interobserver performance variability was observed (P < .001). CONCLUSION: Results suggest that US strain imaging has the potential to aid diagnosis of breast lesions. However, manually tracing lesion boundaries for size ratio differentiation in a busy clinical setting did not match the diagnostic performance levels previously reported. Focusing on measurements of lesion width, along with additional observer training or automated processes, may yield a suitable method for routine clinical application.

Adult↗
PubMed2005

Age-related changes in the pancreas identified by EUS: a prospective evaluation.

BACKGROUND: EUS is an important modality for the diagnosis of pancreatic disease. An understanding of normal pancreatic ductal and parenchymal variation in asymptomatic individuals is essential to improve EUS accuracy. The primary aim of this study was to determine age-related pancreatic parenchymal and ductular changes identifiable on EUS in individuals with no history or symptoms of pancreaticobiliary disease. Secondary aims were to define demographic and clinical factors associated with identifiable pancreatic parenchymal and ductular changes, and to determine the main pancreatic-duct diameter and pancreatic-gland width according to age. METHODS: Patients referred for either upper endoscopy or EUS for an indication unrelated to pancreaticobiliary disease were prospectively enrolled. Patients were stratified by age (<40, 40-60, >60 years). Each patient was assessed for the presence of EUS findings for chronic pancreatitis. Logistic regression was used to identify factors associated with an abnormality. RESULTS: A total of 120 patients (63 men, 57 women; median age, 52 years, interquartile range [IQR] 40-61 years) were prospectively evaluated. At least one parenchymal and/or ductular abnormality was identified in 28% of the patients, with a trend of increasing abnormality with age: <40 years (23%), 40 to 60 years (25%), and >60 years (39%); p = 0.13. No patient had more than 3 abnormal EUS features. Hyperechoic stranding (n = 22) was the most common finding in all age groups. The odds for any abnormality in men (relative to women) was significantly higher (OR 2.9: 95% CI[1.2, 6.8], p = 0.01), with 38% of men and 18% of women having an abnormality. Smoking, low alcohol intake, body mass index, and endoscopic finding were not significantly associated with an abnormal EUS. The overall median pancreatic-gland width and main pancreatic duct diameter were 15 mm (IQR 6-25 mm) and 1.7 mm (IQR 0.9-4.3 mm), respectively. CONCLUSIONS: The frequency of EUS abnormalities in patients without clinical evidence of chronic pancreatitis increases with age, particularly after 60 years of age. The threshold number of EUS criteria for the diagnosis of chronic pancreatitis is variable. However, the typically used standard of 3 or more criteria appears appropriate. A higher number of threshold criteria may be needed in males and to a lesser extent in patients over 40 years of age, which should be related to clinical history and other structural or functional studies. Ductal or parenchymal calculi, ductal narrowing, ductal dilatation, or more than 3 abnormalities appear to be more specific features for the EUS diagnosis of chronic pancreatitis at any age.

Adult↗
PubMed2005

Evaluation of the COBAS TaqMan HCV test with automated sample processing using the MagNA pure LC instrument.

The COBAS TaqMan HCV Test (TaqMan HCV; Roche Molecular Systems Inc., Branchburg, N.J.) for hepatitis C virus (HCV) performed on the COBAS TaqMan 48 Analyzer (Roche Molecular Systems) currently relies on a manual sample processing method. Implementation of an automated sample processing method would facilitate the clinical use of this test. In this study, we evaluated the performance characteristics of TaqMan HCV following automated sample processing by the MagNA Pure LC instrument (MP; Roche Applied Science, Indianapolis, Ind.). The analytical sensitivity of TaqMan HCV following sample processing by MP was 8.1 IU/ml (95% confidence interval, 6.1 to 15.2). The assay showed good linearity (R(2) = 0.99) across a wide range of HCV RNA levels (25 to 5 x 10(6) IU/ml), with coefficients of variation ranging from 10% to 46%. Among 83 clinical specimens, the sensitivity and specificity of TaqMan HCV were 100% and 95%, respectively, when compared to the COBAS AMPLICOR hepatitis C virus test, version 2.0 (COBAS AMPLICOR; Roche Molecular Systems), with TaqMan HCV detecting two more HCV RNA-positive specimens than COBAS AMPLICOR. Both specimens were confirmed to be HCV RNA positive by the VERSANT HCV RNA qualitative test (Bayer HealthCare LLC, Tarrytown, N.Y.). There was also strong correlation (R(2) = 0.95) and good agreement between the results from TaqMan HCV and the VERSANT HCV RNA 3.0 assay (bDNA) (Bayer HealthCare LLC) among a group of 93 clinical specimens. The MP is a versatile, labor-saving sample processing platform suitable for reliable performance of TaqMan HCV.

Automation↗
PubMed2005

Effect of magnetic vs sham-magnetic insoles on nonspecific foot pain in the workplace: a randomized, double-blind, placebo-controlled trial.

OBJECTIVE: To determine whether magnetic insoles are effective for relieving nonspecific subjective foot pain in the workplace, resulting in improved job satisfaction. SUBJECTS AND METHODS: A prospective, randomized, double-blind, placebo-controlled study of health care employees who experienced nonspecific foot pain for at least 30 days, which occurred more days than not, was conducted between February 2001 and January 2002 at the Mayo Clinic in Rochester, Minn. Participants were asked to wear either magnetic or sham-magnetic cushioned insoles for at least 4 hours daily, 4 days per week for 8 weeks. The primary outcome variable was reported foot pain (by categorical response of change from baseline and by visual analog scale) at 4 and 8 weeks. Secondary outcome variables included graded intensity of pain experienced during various daily activities and the effect of insoles on job performance and enjoyment. RESULTS: Among 89 enrolled participants, 6 either withdrew before wearing insoles or were noncompliant with follow-up questionnaires; 83 participants remained for full statistical analysis. Participants in both treatment groups reported improvements in foot pain during the study period. No significant differences in categorical response to pain or pain intensity were seen with use of magnetic vs sham-magnetic insoles. CONCLUSIONS: The magnetic insoles used in this study by a heterogeneous population with chronic nonspecific foot pain were not clinically effective. Findings confirmed that nonspecific foot pain significantly interferes with some employees' ability to enjoy their jobs and that treatment of that pain improves job satisfaction.

Adult↗
PubMed2004

The safety profile of infliximab in patients with Crohn's disease: the Mayo clinic experience in 500 patients.

BACKGROUND AND AIMS: The aim of this study was to evaluate the short- and long-term safety of infliximab in patients with Crohn's disease in clinical practice. METHODS: The medical records of 500 consecutive patients treated with infliximab at the Mayo Clinic were reviewed and abstracted for demographic features and adverse events. The likelihood of a causal relationship to infliximab for each adverse event was determined by calculating an intrinsic likelihood (imputability) score. RESULTS: The 500 patients received a median of 3 infusions and had a median follow-up of 17 months. Forty-three patients (8.6%) experienced a serious adverse event, of which 30 (6%) were related to infliximab. Acute infusion reactions occurred in 19 of 500 patients (3.8%). Serum sickness-like disease occurred in 19 of 500 patients and was attributed to infliximab in 14 (2.8%). Three patients developed drug-induced lupus. One patient developed a new demyelination disorder. Forty-eight patients had an infectious event, of which 41 (8.2%) were attributed to infliximab. Twenty patients had a serious infection: 2 had fatal sepsis, 8 had pneumonia (of which 2 cases were fatal), 6 had viral infections, 2 had abdominal abscesses requiring surgery, one had arm cellulitis, and one had histoplasmosis. Nine patients had a malignant disorder, 3 of which were possibly related to infliximab. A total of 10 deaths were observed. For 5 of these patients (1%), the events leading to death were possibly related to infliximab. CONCLUSIONS: Short- and long-term infliximab therapy is generally well tolerated. However, clinicians must be vigilant for the occurrence of infrequent but serious events, including serum sickness-like reaction, opportunistic infection and sepsis, and autoimmune disorders.

Adolescent↗