Robert A. Lew

A study of the impact of leg ulcers on quality of life: Financial, social, and psychologic implications

BACKGROUND Leg ulcers affect probably 2.5 million persons in the United States, and their prevalence is likely to rise as the population ages. They cause considerable disability, and the cost of treating these chronic wounds is enormous. OBJECTIVE The purpose of this study was to assess the financial, social, and psychologic implications of leg ulcers. METHODS Data were collected by standardized personal interviews with 73 patients with chronic leg ulcers. The interview covered several domains that were selected to determine the impact of a leg ulcer on overall quality of life. RESULTS A significant number of patients had moderate to severe symptoms, principally pain, related to the leg ulcer. Eighty-one percent believed that their mobility was adversely affected by the ulcer; the dominant predictor of impaired mobility was swelling of the leg (p < 0.001). For younger, working patients, leg ulceration was correlated with time lost from work (p < 0.001), job loss (p < 0.01), and adverse effects on finances (p < 0.02). Fifty-eight percent of patients found caring for the ulcer burdensome. There was a strong correlation between time spent on ulcer care and feelings of anger and resentment. Sixty-eight percent of patients reported that the ulcer had a negative emotional impact on their lives, including feelings of fear, social isolation, anger, depression, and negative self-image. CONCLUSION Leg ulcers pose a substantial threat to a variety of dimensions of a patients quality of life.

Lumbar laminectomy alone or with instrumented or noninstrumented arthrodesis in degenerative lumbar spinal stenosis patient selection, costs, and surgical outcomes

Design. A prospective, multicenter observational study. Objectives. 1) Identify correlates of the decision to perform arthrodesis in patients undergoing laminectomy for lumbar spinal stenosis. 2) Compare symptoms, walking capacity, and satisfaction 6 and 24 months after laminectomy alone and laminectomy with noninstrumented and with instrumented arthrodesis. Background Data. Few prospective studies have compared outcomes of laminectomy alone or laminectomy with noninstrumented or with instrumented arthrodesis in patients with degenerative lumbar spinal stenosis. There is uncertainty regarding the optimal use of arthrodesis and instrumentation. Methods. Two hundred seventy‐two patients under‐going surgery for degenerative lumbar stenosis by eight surgeons at four centers were included in the study cohort. Of these, 37 had noninstrumented and 41 had instrumented arthrodesis. Logistic regression identified factors associated with arthrodesis. The principal outcomes‐health status, walking capacity, back and leg pain, and satisfaction with surgery‐were assessed 6 and 24 months postoperatively with univariate and multivariate techniques. Outcomes also were assessed in a restricted cohort of patients with at least 5 mm spondylolisthesis and/or 15° scoliosis. Hospital costs were obtained from a computerized hospital cost accounting system. Results. The major predictor of the decision to perform arthrodesis was the individual surgeon (P = 0.0001). Noninstrumented arthrodesis was associated with superior relief of low back pain at 6 months (P = 0.004) and 24 months (P = 0.01). This difference persisted in multivariate analyses, with borderline statistical significance. There were no significant differences in the other outcomes across treatment groups. Mean hospital costs of laminectomy alone and noninstrumented and instrumented arthrodesis were

A Cross-sectional Measurement of Medical Student Empathy

12,615,

A Comprehensive Care Management Program to Prevent Chronic Obstructive Pulmonary Disease Hospitalizations: A Randomized, Controlled Trial

18,495, and

Therapies for Active Rheumatoid Arthritis after Methotrexate Failure

25,914, respectively (P = 0.0001). Conclusion. Findings were limited by the small number of participating surgeons, modest sample size that produced P values of borderline significance, and nonrandomized design. With these caveats in mind, the authors conclude: (1) The individual surgeon was a more important correlate of the decision to perform arthrodesis than clinical variables such as spondylolisthesis. (2) Noninstrumented arthrodesis resulted in superior relief of back pain after 6 and 24 months. (3) Instrumented arthrodesis was the most costly option. These results highlight the need for randomized controlled trials and cost effectiveness analyses of lumbar arthrodesis and instrumentation in patients with degenerative lumbar spinal stenosis.

Clinical Correlates of Patient Satisfaction After Laminectomy for Degenerative Lumbar Spinal Stenosis

BackgroundEmpathy is important in the physician–patient relationship. Prior studies have suggested that physician empathy may decline with clinical training.ObjectiveTo measure and examine student empathy across medical school years.Design and ParticipantsA cross-sectional study of students at Boston University School of Medicine in 2006. Incoming students plus each class near the end of the academic year were surveyed.MeasurementsThe Jefferson Scale of Physician Empathy–Student Version (JSPE-S), a validated 20-item self-administered questionnaire with a total score ranging from 20 to 140. JSPE-S scores were controlled for potential confounders such as gender, age, anticipated financial debt upon graduation, and future career interest.Results658 students participated in the study (81.4% of the school population). The first-year medical student class had the highest empathy scores (118.5), whereas the fourth-year class had the lowest empathy scores (106.6). Measured empathy differed between second- and third-year classes (118.2 vs 112.7, P < .001), corresponding to the first year of clinical training. Empathy appears to increase from the incoming to the first-year class (115.5 vs 118.5, P = .02). Students preferring people-oriented specialties had higher empathy scores than students preferring technology-oriented specialties (114.6 vs 111.4, P = .002). Female students were more likely than male students to choose people-oriented specialties (51.5 vs 26.9%, P < .001). Females had higher JSPE-S scores than males (116.5 vs 112.1, P < .001). Age and debt did not affect empathy scores.ConclusionsEmpathy scores of students in the preclinical years were higher than in the clinical years. Efforts are needed to determine whether differences in empathy scores among the classes are cohort effects or represent changes occurring in the course of medical education. Future research is needed to confirm whether clinical training impacts empathy negatively, and, if so, whether interventions can be designed to mitigate this impact.

The Association Between Statins and Cancer Incidence in a Veterans Population

BACKGROUND Improving a patients ability to self-monitor and manage changes in chronic obstructive pulmonary disease (COPD) symptoms may improve outcomes. OBJECTIVE To determine the efficacy of a comprehensive care management program (CCMP) in reducing the risk for COPD hospitalization. DESIGN A randomized, controlled trial comparing CCMP with guideline-based usual care. (ClinicalTrials.gov registration number: NCT00395083) SETTING: 20 Veterans Affairs hospital-based outpatient clinics. PARTICIPANTS Patients hospitalized for COPD in the past year. INTERVENTION The CCMP included COPD education during 4 individual sessions and 1 group session, an action plan for identification and treatment of exacerbations, and scheduled proactive telephone calls for case management. Patients in both the intervention and usual care groups received a COPD informational booklet; their primary care providers received a copy of COPD guidelines and were advised to manage their patients according to these guidelines. Patients were randomly assigned, stratifying by site based on random, permuted blocks of variable size. MEASUREMENTS The primary outcome was time to first COPD hospitalization. Staff blinded to study group performed telephone-based assessment of COPD exacerbations and hospitalizations, and all hospitalizations were blindly adjudicated. Secondary outcomes included non-COPD health care use, all-cause mortality, health-related quality of life, patient satisfaction, disease knowledge, and self-efficacy. RESULTS Of the eligible patients, 209 were randomly assigned to the intervention group and 217 to the usual care group. Citing serious safety concerns, the data monitoring committee terminated the intervention before the trials planned completion after 426 (44%) of the planned total of 960 patients were enrolled. Mean follow-up was 250 days. When the study was stopped, the 1-year cumulative incidence of COPD-related hospitalization was 27% in the intervention group and 24% in the usual care group (hazard ratio, 1.13 [95% CI, 0.70 to 1.80]; P= 0.62). There were 28 deaths from all causes in the intervention group versus 10 in the usual care group (hazard ratio, 3.00 [CI, 1.46 to 6.17]; P= 0.003). Cause could be assigned in 27 (71%) deaths. Deaths due to COPD accounted for the largest difference: 10 in the intervention group versus 3 in the usual care group (hazard ratio, 3.60 [CI, 0.99 to 13.08]; P= 0.053). LIMITATIONS Available data could not fully explain the excess mortality in the intervention group. Ability to assess the quality of the educational sessions provided by the case managers was limited. CONCLUSION A CCMP in patients with severe COPD had not decreased COPD-related hospitalizations when the trial was stopped prematurely. The CCMP was associated with unanticipated excess mortality, results that differ markedly from similar previous trials. A data monitoring committee should be considered in the design of clinical trials involving behavioral interventions.

Prognostic Factors for Patients with Clinical Stage I Melanoma of Intermediate Thickness (1.51–3.99 mm)* A Conceptual Model for Tumor Growth and Metastasis

BACKGROUND Few blinded trials have compared conventional therapy consisting of a combination of disease-modifying antirheumatic drugs with biologic agents in patients with rheumatoid arthritis who have active disease despite treatment with methotrexate--a common scenario in the management of rheumatoid arthritis. METHODS We conducted a 48-week, double-blind, noninferiority trial in which we randomly assigned 353 participants with rheumatoid arthritis who had active disease despite methotrexate therapy to a triple regimen of disease-modifying antirheumatic drugs (methotrexate, sulfasalazine, and hydroxychloroquine) or etanercept plus methotrexate. Patients who did not have an improvement at 24 weeks according to a prespecified threshold were switched in a blinded fashion to the other therapy. The primary outcome was improvement in the Disease Activity Score for 28-joint counts (DAS28, with scores ranging from 2 to 10 and higher scores indicating more disease activity) at week 48. RESULTS Both groups had significant improvement over the course of the first 24 weeks (P=0.001 for the comparison with baseline). A total of 27% of participants in each group required a switch in treatment at 24 weeks. Participants in both groups who switched therapies had improvement after switching (P<0.001), and the response after switching did not differ significantly between the two groups (P=0.08). The change between baseline and 48 weeks in the DAS28 was similar in the two groups (-2.1 with triple therapy and -2.3 with etanercept and methotrexate, P=0.26); triple therapy was noninferior to etanercept and methotrexate, since the 95% upper confidence limit of 0.41 for the difference in change in DAS28 was below the margin for noninferiority of 0.6 (P=0.002). There were no significant between-group differences in secondary outcomes, including radiographic progression, pain, and health-related quality of life, or in major adverse events associated with the medications. CONCLUSIONS With respect to clinical benefit, triple therapy, with sulfasalazine and hydroxychloroquine added to methotrexate, was noninferior to etanercept plus methotrexate in patients with rheumatoid arthritis who had active disease despite methotrexate therapy. (Funded by the Cooperative Studies Program, Department of Veterans Affairs Office of Research and Development, and others; CSP 551 RACAT ClinicalTrials.gov number, NCT00405275.)

Screening for melanoma/skin cancer: Theoretic and practical considerations

Study Design Prospective multicenter observational study of the outcome of surgery for degnerative lumbar spinal stenosis. Objectives To identify correlates of patient satisfaction with the results of surgery. Summary of Background Data Little published information exists on correlates of patient satisfaction after surgery for spinal stenosis. Methods Preoperative and 6-month follow-up data for 194 patients were analyzed. Associations between preoperative variables and satisfaction with the results of surgery were examined in univariate and multivariate models. Results In multiple linear regression models that adjusted for the effects of age, gender, individual surgeon, number of interspaces decompressed, whether a fusion was performed, depression score, and overall level of pain, the predominance of back (as opposed to leg) pain, greater comorbidity, and worse preoperative functional status were assodated with lower patient satisfaction. The regression model explained just 15% of the variance in patient satisfaction. Conclusions Patients bothered predominantly by back pain preoperatively and those with greater medical comorbidity and functional disability are significantly less satisfied with the results of surgery for degenerative lumbar spinal stenosis.

Long-Acting Risperidone and Oral Antipsychotics in Unstable Schizophrenia

BACKGROUND Meta-analyses of trials of 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitors or statins for cardiovascular disease prevention have failed to show any statistically significant benefit of statins for cancer prevention. However, these trials included relatively young participants, who develop few cancers, and their follow-up periods may have been too short to detect an association between statin use and cancer incidence. We investigated this association in a population of veterans. METHODS We identified patients using antihypertensive medications but no cholesterol-lowering medications (n = 25,594) and patients using statins (n = 37,248) who were enrolled in the Veterans Affairs New England Healthcare System between January 1, 1997, and December 31, 2005. Age- and multivariable-adjusted Cox proportional hazards models were used to calculate the hazard ratio (HR) and its 95% confidence interval (CI) for cancer incidence, excluding nonmelanoma skin cancer, among patients taking statins compared with patients taking antihypertensive medications and among patients grouped by statin dose (as equivalent simvastatin dose). All statistical tests were two-sided. RESULTS The absolute incidence of total cancers was 9.4% among statin users and 13.2% among nonusers (difference = 3.8%, 95% CI = 3.3% to 4.3%, P(difference) < .001). Statin users had a statistically significant lower risk for total cancer than nonusers after adjustment for age (HR = 0.76, 95% CI = 0.73 to 0.80) and multiple potential confounders (HR = 0.74, 95% CI = 0.70 to 0.78). After multivariable adjustment, a statistically significantly decreased risk of all cancers was also associated with increasing statin use (P(trend) < .001). CONCLUSIONS Patients using statins may be at lower risk for developing cancer. Additional observational studies and randomized trials of statins for cancer prevention are warranted.