A comparison of small monetary incentives to convert survey non-respondents: a randomized control trial.

BACKGROUND: Maximizing response rates is critically important in order to provide the most generalizable and unbiased research results. High response rates reduce the chance of respondents being systematically different from non-respondents, and thus, reduce the risk of results not truly reflecting the study population. Monetary incentives are often used to improve response rates, but little is known about whether larger incentives improve response rates in those who previously have been unenthusiastic about participating in research. In this study we compared the response rates and cost-effectiveness of a $5 versus $2 monetary incentive accompanying a short survey mailed to patients who did not respond or refused to participate in research study with a face-to-face survey. METHODS: 1,328 non-responders were randomly assigned to receive $5 or $2 and a short, 10-question survey by mail. Reminder postcards were sent to everyone; those not returning the survey were sent a second survey without incentive. Overall response rates, response rates by incentive condition, and odds of responding to the larger incentive were calculated. Total costs (materials, postage, and labor) and incremental cost-effectiveness ratios were also calculated and compared by incentive condition. RESULTS: After the first mailing, the response rate within the $5 group was significantly higher (57.8% vs. 47.7%, p<.001); after the second mailing, the difference narrowed by 80%, resulting in a non-significant difference in cumulative rates between the $5 and $2 groups (67.3% vs. 65.4%, respectively, p=.47). Regardless of incentive or number of contacts, respondents were significantly more likely to be male, white, married, and 50-75 years old. Total costs were higher with the larger versus smaller incentive ($13.77 versus $9.95 per completed survey). CONCLUSIONS: A $5 incentive provides a significantly higher response rate than a $2 incentive if only one survey mailing is used but not if two survey mailings are used.

Mental health, frequency of healthcare visits, and colorectal cancer screening.

BACKGROUND: Research regarding the association between mental health and colorectal cancer (CRC) screening has produced mixed results. Variations may be explained by methodology, including whether potential confounders such as frequency of healthcare visits are considered. OBJECTIVE: We examined the association between mental health and CRC screening, before and after controlling for demographics, comorbidities, and outpatient visit frequency. DESIGN: Observational study based on a retrospective cohort. SUBJECTS: A total of 855 veterans receiving care at a Veterans Affairs Medical Center. MEASURES: Medical record data were used to assess CRC screening rates and mental health status (number of diagnoses and the presence of depression, anxiety, posttraumatic stress disorder, substance, or psychotic disorders). Logistic regression was used to estimate the association between mental health diagnoses and CRC screening, before and after controlling for covariates. RESULTS: Bivariate analyses suggested that CRC screening rates were higher for patients with a history of one or more mental health diagnoses (57% vs. 47%, P < 0.01). However, adjusting for timing of mental health diagnosis and outpatient visit frequency resulted in significant negative associations between CRC screening and all measures of mental health except posttraumatic stress disorder. CONCLUSIONS: Estimates of the association between mental health and CRC screening that do not adjust for outpatient visit frequency may be misleading. Veterans with mental health diagnoses were significantly less likely to be screened for CRC than their counterparts with no mental health diagnoses and an equal number of outpatient visits.

Variation in estimates of limited health literacy by assessment instruments and non-response bias.

OBJECTIVES: This paper compares estimates of poor health literacy using two widely used assessment tools and assesses the effect of non-response on these estimates. STUDY DESIGN AND SETTING: A total of 4,868 veterans receiving care at four VA medical facilities between 2004 and 2005 were stratified by age and facility and randomly selected for recruitment. Interviewers collected demographic information and conducted assessments of health literacy (both REALM and S-TOFHLA) from 1,796 participants. Prevalence estimates for each assessment were computed. Non-respondents received a brief proxy questionnaire with demographic and self-report literacy questions to assess non-response bias. Available administrative data for non-participants were also used to assess non-response bias. RESULTS: Among the 1,796 patients assessed using the S-TOFHLA, 8% had inadequate and 7% had marginal skills. For the REALM, 4% were categorized with 6th grade skills and 17% with 7-8th grade skills. Adjusting for non-response bias increased the S-TOFHLA prevalence estimates for inadequate and marginal skills to 9.3% and 11.8%, respectively, and the REALM estimates for < or = 6th and 7-8th grade skills to 5.4% and 33.8%, respectively. CONCLUSIONS: Estimates of poor health literacy varied by the assessment used, especially after adjusting for non-response bias. Researchers and clinicians should consider the possible limitations of each assessment when considering the most suitable tool for their purposes.

Colorectal cancer screening mode preferences among US veterans.

OBJECTIVE: To assess colorectal cancer (CRC) screening mode preferences and correlates of these preferences among US veterans at average risk for CRC. METHOD: A cross-sectional survey of a nationally representative sample of VA patients was conducted between January 2005 and December 2006. We report preference distributions for screening modes among 2068 average-risk veterans and across patient subgroups based on personal, behavioral, and environmental factors. Independent predictors of preferences are identified through hierarchical logistic regression models. RESULTS: Colonoscopy (37%) was the most preferred mode followed by fecal occult blood test (FOBT) (29%). The strongest predictors of preferences were previous screening experience, provider recommendation, and use of non-VA healthcare services. Participants in higher socioeconomic groups were more likely to choose colonoscopy and less likely to indicate no preference. CONCLUSION: Screening programs that offer only one mode fail to accommodate the preferences of a substantial proportion of patients. Within the VA, adding screening colonoscopy to programs currently offering only FOBT is likely to increase preferences for colonoscopy, as patients incorporate provider recommendations for and personal experience with colonoscopy into their preferences. This is likely to disproportionately benefit lower socioeconomic groups who do not currently have access to non-VA colonoscopy services.

Accuracy of teledermatology for pigmented neoplasms.

BACKGROUND: Accurate diagnosis and management of pigmented lesions is critical because of the morbidity and mortality associated with melanoma. OBJECTIVE: We sought to compare accuracy of store-and-forward teledermatology for pigmented neoplasms with standard, in-person clinic dermatology. METHODS: We conducted a repeated measures equivalence trial involving veterans with pigmented skin neoplasms. Each lesion was evaluated by a clinic dermatologist and a teledermatologist; both generated a primary diagnosis, up to two differential diagnoses, and a management plan. The primary outcome was aggregated diagnostic accuracy (match of any chosen diagnosis with histopathology). We also compared the severity of inappropriately managed lesions and, for teledermatology, evaluated the incremental change in accuracy when polarized light dermatoscopy or contact immersion dermatoscopy images were viewed. RESULTS: We enrolled 542 patients with pigmented lesions, most were male (96%) and Caucasian (97%). The aggregated diagnostic accuracy rates for teledermatology (macro images, polarized light dermatoscopy, and contact immersion dermatoscopy) were not equivalent (95% confidence interval for difference within +/-10%) and were inferior (95% confidence interval lower bound <10%) to clinic dermatology. In general, the addition of dermatoscopic images did not significantly change teledermatology diagnostic accuracy rates. In contrast to diagnostic accuracy, rates of appropriate management plans for teledermatology were superior and/or equivalent to clinic dermatology (all image types: all lesions, and benign lesions). However, for the subgroup of malignant lesions (n = 124), the rate of appropriate management was significantly worse for teledermatology than for clinic dermatology (all image types). Up to 7 of 36 index melanomas would have been mismanaged via teledermatology. LIMITATIONS: Nondiverse study population and relatively small number of melanomas were limitations. CONCLUSIONS: In general, the diagnostic accuracy of teledermatology was inferior whereas management was equivalent to clinic dermatology. However, for the important subgroup of malignant pigmented lesions, both diagnostic and management accuracy of teledermatology was generally inferior to clinic dermatology and up to 7 of 36 index melanomas would have been mismanaged via teledermatology. Teledermatology and teledermatoscopy should be used with caution for patients with suspected malignant pigmented lesions.

Accuracy of teledermatology for nonpigmented neoplasms.

BACKGROUND: Studies of teledermatology utilizing the standard reference of histopathology are lacking. OBJECTIVE: To compare accuracy of store-and-forward teledermatology for non-pigmented neoplasms with in-person dermatology. METHODS: This study was a repeated-measures equivalence trial involving veterans with non-pigmented skin neoplasms. Each lesion was evaluated by an in-person dermatologist and a teledermatologist; both generated a primary diagnosis, up to two differential diagnoses, and management plan. The primary outcome was aggregated diagnostic accuracy (percent correct matches of any chosen diagnosis with histopathology). Secondary outcomes included management plan accuracy (percent correct matches with expert panel management plan). Additional analyses included evaluation of the incremental effect of using polarized light dermatoscopy in addition to standard macro images, and evaluating benign and malignant lesion subgroups separately. RESULTS: Most of the 728 participants were male (97.8%) and Caucasian (98.9%). The aggregated diagnostic accuracy (primary outcome) of teledermatology (macro images) was not equivalent (95% confidence interval [CI] for difference within +/-10%) and was inferior (95% CI lower bound <10%) to in-person dermatology for all lesions and the subgroups of benign and malignant lesions. However, management plan accuracy was equivalent. Teledermatology aggregated diagnostic accuracy using polarized light dermatoscopy was significantly better than for macro images alone (P = .0017). The addition of polarized light dermatoscopy showed the same pattern for malignant lesions, but not for benign lesions. Most interestingly, for malignant lesions, the addition of polarized light dermatoscopy yielded equivalent aggregated diagnostic accuracy rates. LIMITATIONS: Non-diverse study population. CONCLUSIONS: Using macro images, the diagnostic accuracy of teledermatology was inferior to in-person dermatology, but accuracy of management plans was equivalent. The addition of polarized light dermatoscopy yielded significantly better aggregated diagnostic accuracy, but management plan accuracy was not significantly improved. For the important subgroup of malignant lesions, the addition of polarized light dermatoscopy yielded equivalent diagnostic accuracy between teledermatologists and clinic dermatologists.

Validation of screening questions for limited health literacy in a large VA outpatient population.

OBJECTIVES: Previous studies have shown that a single question may identify individuals with inadequate health literacy. We evaluated and compared the performance of 3 health literacy screening questions for detecting patients with inadequate or marginal health literacy in a large VA population. METHODS: We conducted in-person interviews among a random sample of patients from 4 VA medical centers that included 3 health literacy screening questions and 2 validated health literacy measures. Patients were classified as having inadequate, marginal, or adequate health literacy based on the Short Test of Functional Health Literacy in Adults (S-TOFHLA) and the Rapid Estimate of Adult Literacy in Medicine (REALM). We evaluated the ability of each of 3 questions to detect: 1) inadequate and the combination of "inadequate or marginal" health literacy based on the S-TOFHLA and 2) inadequate and the combination of "inadequate or marginal" health literacy based on the REALM. MEASUREMENTS AND MAIN RESULTS: Of 4,384 patients, 1,796 (41%) completed interviews. The prevalences of inadequate health literacy were 6.8% and 4.2%, based on the S-TOHFLA and REALM, respectively. Comparable prevalences for marginal health literacy were 7.4% and 17%, respectively. For detecting inadequate health literacy, "How confident are you filling out medical forms by yourself?" had the largest area under the Receiver Operating Characteristic Curve (AUROC) of 0.74 (95% CI: 0.69-0.79) and 0.84 (95% CI: 0.79-0.89) based on the S-TOFHLA and REALM, respectively. AUROCs were lower for detecting "inadequate or marginal" health literacy than for detecting inadequate health literacy for each of the 3 questions. CONCLUSION: A single question may be useful for detecting patients with inadequate health literacy in a VA population.

Validity of self-reported nail counts in patients with onychomycosis: A retrospective pilot analysis.

BACKGROUND: Onychomycosis (fungal infection of the toenails or fingernails) is common, affecting up to 8% of the general population. Telephone and mailed surveys conducted to study this disease are usually completed via patient self-report. The validity of the counts of diseased nails reported by the patients participating in these surveys has not been established. OBJECTIVE: The aim of this study was to assess the interrater agreement between patient and health care professional (HCP) counts of affected nails in patients with onychomycosis. METHODS: Patient and HCP counts of infected toenails and fingernails corresponding to a total of 567 patients originating from 3 different clinical trials were retrospectively analyzed. All these patients were initially classified as mycologically positive for toenail onychomycosis, and all 3 trials used identical self-administered questions regarding counts of infected toenails and fingernails. The level of agreement between patient versus HCP counts of infected toenails and fingernails (based on collapsed and uncollapsed counts) was measured using the quadratically weighted kappa statistic. RESULTS: Thirty-eight percent (213/554, 95% confidence interval [CI] = 35% to 43%) of the 554 patients with self-reported and HCP counts of infected toenails had exact agreement; for these 554 patients, quadratically weighted kappa = 0.47 (95% CI: 0.40 to 0.54). The highest agreement rates-79, 62, and 50%-correspond to the patients with HCP counts of affected toenails equaling 1, 2, and 10, respectively; that is, HCP counts at the extremes. The agreement rates ranged from 3% to 31% for the remaining patients with HCP counts between 3 and 9. Patients tended to undercount affected toenails, irrespective of the number of affected toenails counted by HCPs. No statistically significant association was found between agreement rates and whether or not the patients had been previously treated for toenail onychomycosis (P = .91). A marginally nonsignificant association of increasing agreement rates with increasing disease duration was observed (P = .06). Among the patients who reported one or more affected fingernails (n = 122), percent agreement was similar to that of toenails (41%, 95% CI: 33.0 to 50.0%). LIMITATIONS: This pilot study is limited by its retrospective design, its homogeneous group of patients (predominantly white, male veterans), and the fact that information on intraobserver and interobserver reliability was not obtained from all of the 3 clinical trials, the sources for this analysis. CONCLUSIONS: Patients tend to undercount affected nails as compared to HCPs. Reliance on self-reported counts in epidemiological surveys may lead to an inaccurate, underestimate of disease severity.

NailQoL: a quality-of-life instrument for onychomycosis.

BACKGROUND: The disease burden onychomycosis is not trivial. The aim is to develop a quality of life instrument to measure the onychomycosis burden. METHODS: 402 patients with mycologically-confirmed onychomycosis completed a baseline questionnaire of 39 quality of life items (modified Skindex-29 questions and 10 additional nail-specific questions). Internal consistency, reproducibility and responsiveness of the final instrument, NailQoL were measured. RESULTS: 15 items consisting of symptom (3), emotion (10), and functional (2) domains were retained in NailQoL. Symptom and emotion subscales = 0.80-0.92. Administration alpha demonstrated good internal consistency (Cronbach's of the instrument to 46 patients at one month after baseline revealed good reproducibility (ICC 0.88-0.91). Responsiveness was measured in 292 patients at 18 months; statistically significant better NailQoL scores were found in individuals with complete cure (mycological and clinical) (P < 0.01). CONCLUSION: NailQoL represents a new concise, valid, reliable, and responsive instrument for measuring burden of skin disease for patients with onychomycosis.

Cost-effectiveness of diagnostic tests for toenail onychomycosis: a repeated-measure, single-blinded, cross-sectional evaluation of 7 diagnostic tests.

OBJECTIVE: Our purpose was to estimate and compare the cost-effectiveness of the most commonly used diagnostic tests for onychomycosis: potassium hydroxide preparation (KOH), interpreted both by a dermatologist (KOH-CLINIC) and a laboratory technician (KOH-LAB); KOH with dimethyl sulfoxide (KOH-DMSO) and with chlorazol black E (KOH-CBE), interpreted by a dermatologist; culture using dermatophyte test medium, culture with Mycobiotic and Inhibitory Mold Agar (Cx); and histopathologic analysis using periodic acid-Schiff stain (PAS). METHODS: This was a repeated-measure, blinded, cross-sectional study conducted at the Minneapolis Veterans Affairs Medical Center. Inclusion criteria included: at least one toenail with 25% or more clinical disease, which was defined as subungual debris with onycholysis and/or onychauxis. Exclusion criteria included other nail dystrophies, use of oral antifungal medication for 2 months or longer within the past year, or topical ciclopirox lacquer within 6 weeks of enrollment. The main outcome measure was the cost-effectiveness (Medicare and non-Medicare costs) of 7 diagnostic tests. Sensitivity (at least 3 positive tests) was the unit of effectiveness. RESULTS: Two hundred four participants were enrolled; their average age was 69.5 years and 95.5% were male. PAS was the most sensitive test (98.8%); it was statistically significantly more sensitive than all other diagnostic tests except KOH-CBE (94.3%). Dermatophye test medium was the least sensitive test (57.3%). KOH-CBE was statistically significantly more cost effective than any other test, with the exception of KOH-CLINIC and KOH-LAB. PAS was the least cost effective. LIMITATIONS: Test specificities were not evaluated. CONCLUSION: KOH-CBE should be the test of choice for practitioners confident in interpreting KOH preparations because of its combination of high sensitivity and cost-effectiveness.

Pulse versus continuous terbinafine for onychomycosis: a randomized, double-blind, controlled trial.

BACKGROUND: Effective treatments for onychomycosis are expensive. Previous studies suggest that less costly, pulsed doses of antifungal medications may be as effective as standard, continuous doses. Terbinafine is the current treatment of choice for toenail onychomycosis. OBJECTIVE: Our purpose was to determine whether pulse-dose terbinafine is as effective as standard continuous-dose terbinafine for treatment of toenail onychomycosis. METHODS: We conducted a double-blind, randomized, noninferiority, clinical intervention trial in the Minneapolis Veterans Affairs Medical Center. The main inclusion criteria for participants were a positive dermatophyte culture and at least 25% distal subungual clinical involvement. Six hundred eighteen volunteers were screened; 306 were randomized. Terbinafine, 250 mg daily for 3 months (continuous) or terbinafine, 500 mg daily for 1 week per month for 3 months (pulse) was administered. The primary outcome measure was mycological cure of the target toenail at 18 months. Secondary outcome measures included clinical cure and complete (clinical plus mycological) cure of the target toenail and complete cure of all 10 toenails. RESULTS: Results of an intent-to-treat analysis did not meet the prespecified criterion for noninferiority but did demonstrate the superiority of continuous-dose terbinafine for: mycological cure of the target toenail (70.9% [105/148] vs 58.7% [84/143]; P =.03, relative risk [RR] of 1.21 [95% confidence interval (CI), 1.02-1.43]); clinical cure of the target toenail (44.6% [66/148] vs 29.3% [42/143]; P =.007, RR =1.52 [95% CI, 1.11-2.07); complete cure of the target toenail (40.5% [60/148] vs 28.0% [40/143]; P =.02, RR=1.45 [95% CI, 1.04-2.01); and complete cure of all 10 toenails (25.2% [36/143] vs 14.7% [21/143]; P =.03, RR =1.71 [95% CI, 1.05-2.79). Tolerability of the regimens did not differ significantly between the groups (chi2 =1.63; P =.65). LIMITATIONS: The study population primarily consisted of older men with severe onychomycosis. CONCLUSIONS: This study demonstrated the superiority of continuous- over pulse-dose terbinafine. We also found this expensive therapy to be much less effective than previously believed, particularly for achieving complete cure of all 10 toenails.

Use of intraoperative electron beam radiotherapy in the management of retroperitoneal soft tissue sarcomas.

PURPOSE: To evaluate the disease control, survival results, and tolerance of intraoperative electron beam radiotherapy (IOERT) as a component of treatment for retroperitoneal soft tissue sarcomas. METHODS AND MATERIALS: Between March 1981 and September 1995, 87 patients with primary (n = 43) or recurrent (n = 44) retroperitoneal or intrapelvic sarcomas received IOERT as a component of treatment at the Mayo Clinic. The tumors were high grade in 54 patients (62%) and low grade in 33 (38%). The median tumor size was 10 cm (range 2-36). All patients underwent maximal surgical resection with IOERT; in 72 patients, only microscopic or no residual tumor remained. The IOERT doses ranged from 8.75 to 30 Gy (median 15). All primary tumors received external beam irradiation (EBRT) with a median dose of 48.6 Gy. Thirty-four of the 44 recurrent tumors received EBRT to a median dose of 45 Gy. All patients were followed prospectively for outcome and toxicity evaluation. RESULTS: The median follow-up, based on 46 patients (53%) currently alive, was 3.5 years. The overall estimated 5-year survival was 47%. For patients with tumors > or = 10 cm, the 5-year overall survival was significantly poorer (28%) than for those with smaller lesions (60%) (p = 0.01). Neither primary vs. recurrent status nor tumor grade had a significant impact on survival. Patients with gross residual tumor had a marginally significantly poorer survival compared with patients with microscopic or no residual tumor, with a 5-year survival rate of 37% and 52%, respectively (p = 0.08). A total of 49 patients (56%) experienced failure, including 20 local recurrences (23%). The median time to failure was 2.3 years. Four recurrences were within the IOERT field, 3 within the IOERT and EBRT field, and 13 within the EBRT field alone. The 3- and 5-year estimated local control rate was 77% and 59%, respectively. Local control was marginally significantly affected by the amount of residual tumor, with a 5-year local control rate of 41% for those with gross residual tumor, 60% for those with microscopic residual tumor, and 100% for those with no residual tumor (p = 0.09). Gastrointestinal complications were recorded in 12 incidences (Grade 3 or higher toxicity). These complications were believed to be secondary to surgery and/or EBRT in 10 of the 12 cases. Seven patients had fistula formation, and 3 experienced severe proctitis. Grade 3 peripheral neurologic toxicities occurred in 9 patients (10%), but none had pain as a component of their neuropathy. CONCLUSION: Retroperitoneal soft tissue sarcomas can be treated with an aggressive combined approach of EBRT, surgery, and IOERT, with acceptable toxicity. Local control in primary disease appears to be improved in this retrospective series with this approach. Distant disease control and options for recurrent disease needs further definition.