Americans' Awareness of Access Changes and Utilization of Telehealth During COVID-19: A Survey in the United States.

Background: We examine how and why Americans have experienced interrupted health care during the COVID-19 pandemic and measure awareness and usage of expanded benefits offered by health insurers and employers. We use an expanded concept of health literacy to include knowledge of access conditions and consider if patients' knowledge of the health system may relate to utilization of care. Methods: We conducted an online survey of 451 U.S. adults in September 2020, asking respondents about their health care experiences since March 1, 2020. This survey measured usage of medical care and awareness of the efforts made by government, private insurers, and employers to increase access to benefits such as telehealth services, well-being and mental health programs, and new prescription options. Results: The most common reasons cited for postponing or skipping medical appointments included fears over COVID-19 exposure, following local restrictions, or wanting to preserve resources for those with COVID-19. Our survey also finds that many Americans are largely unaware of whether they have access to expanded benefits implemented during the pandemic. Critically, respondents who recalled telehealth and prescription medication benefits being promoted were more likely to report using such benefits. Conclusion: This research suggests that greater attention to health literacy can help promote participation in the system by patients and has the potential to lead to improved health outcomes and greater adherence to treatment plans. Telehealth may offer patients increased opportunities to consult with their physicians for ailments that they might otherwise have delayed seeking care.

Retrospective Database Analysis to Explore Patterns and Economic Burden of Switchback to Brand After Generic or Authorized Generic Utilization.

Background: Despite demonstration of bioequivalence of generics to brands and the potential for reduced costs, some patients switch back from a generic to the brand. A prior retrospective analysis suggested that this switchback rate may be lower among patients that had initially switched to authorized generics (AG), often both produced and marketed by the brand company, compared to those initially switched to another generic. Objective: Explore switching patterns of brands, AGs, and generics, switchback rates, and the potential impact of switchbacks on healthcare costs. Methods: An analysis of the Pharmetrics Plus™ database (2007-2019), a United States (US) payer administrative database, was conducted to examine the use of Upjohn medications available as AGs across multiple therapeutic areas. Patients initiating treatment with brand medication in the 6 months prior to generic market entry were identified and switch rates to generics and AGs, as well as switchback rates, were evaluated. Costs were descriptively compared between patients who switched back to brand and those who remained on any generic. Results: Across 14 brand medications, more than half of the patients initiating treatment with the brand medication were switched to a generic. Generally, switching to AG, which ranged from 0.5 to 39.6%, was lower than switching to non-AG generics (16.7-79.9%). The comparison of switchback rates from AGs to brand and non-AGs to brand showed similar results (AG:1.3-7.5%; non-AG:1.4-12.9%); however, the most substantial differences were observed where non-AG switchbacks were higher. Patients that switched back to brand remained on AG or generic for an average of 1-3 months (32-88 days). The analysis showed a tendency towards increased medical costs in the period immediately preceding switchback for all medications except sildenafil in both indications (erectile dysfunction and pulmonary arterial hypertension). For the remaining medications, medical costs ranged from $63 to $1544 higher for the switchback population. Pharmacy costs similarly tended to be higher for patients who had a switchback, with the exception of sildenafil for pulmonary arterial hypertension and sirolimus. Conclusion: Patients receiving a brand medication are likely to be switched to a generic upon market availability. Some patients switch back to the brand medication, usually within 1-3 months; this may be associated with increased medical costs. Additional research is needed to understand switching, its potential disruption to patients, and the role of brands, generics, and AGs.

Understanding treatment patterns and patient-reported outcomes associated with the use of authorized generics and corresponding independent generics across multiple therapeutic areas.

OBJECTIVES: To assess patient characteristics, treatment patterns, and patient-reported outcomes (PROs) associated with authorized generics (AGs) and independent generics (IGs) use. METHODS: Prescription claims and National Health and Wellness Survey (NHWS) data were linked. Adults with billable national drug code (AG or IG), NHWS completion from June 2015 to July 2019, AG or IG on-hand at NHWS completion, and continuous insurance eligibility in 12 months pre- and post-NHWS completion were included. To be included, all unique medication formulations had to have at least one AG and one IG observation. PRO index date was NHWS completion; claims index date was defined as the first prescription claim identified during the 180-day period prior to NHWS completion for the same active ingredient and formulation type that was on-hand at NHWS completion. RESULTS: Patients (N = 20,229; 17.2% AG users) in six therapeutic areas (attention deficit-hyperactivity disorder [ADHD], antidepressants, beta blockers [BBs], calcium channel blockers [CCBs], statins, and thyroid) were included. Generally, AG (vs. IG) users were younger and differed in regional access and insurance type (all, p < .05). In multivariable analysis, significant differences were observed for presenteeism and overall work impairment (BBs), healthcare provider visits (BBs), and indirect costs (thyroid) (all, p < .05). AG and IG users differed in persistence (ADHD and statins; both, p < .05) and switch (BBs and CCBs; both, p < .01) rates. CONCLUSIONS: PRO differences were often small in magnitude and varied by therapeutic area. The impact of switching should consider observed PRO differences, patient preferences, and market availability of AG and IG alternatives.

Americans' Health Priorities During the COVID-19 Pandemic.

OBJECTIVES: This study aimed to examine how Americans' opinions of the seriousness of various health-related problems have changed over time and to quantify the public's preferences for research prioritization. METHODS: We conducted a survey that asked respondents to rate the seriousness of 80 health-related problems on a 4-point Likert scale ("very serious problem," "somewhat serious problem," "not too serious of a problem," or "not a problem at all"). Results were compared with past surveys from 2001 and 2013 that examined the same set of health-related problems (with the exception of COVID-19). The survey also included best-worst scaling questions that asked respondents to select, from 20 health problems, those they considered most and least important for research funding. Respondents were recruited from the KnowledgePanel, a nationally representative sample of American households. RESULTS: A total of 768 adults completed the survey between September 3, 2020, and September 14, 2020. The health-related problems that Americans consider to be "very serious" generally align with the leading causes of death and noncommunicable diseases such as heart disease, diabetes, and mental health; nevertheless, several social determinants of health are also identified. COVID-19 was an unsurprising top priority, whereas cancer remains the highest and a persistent priority for research funding. CONCLUSIONS: Americans consider a diverse set of health-related problems to be "very serious," with recognition of social determinants of health rising. Our findings offer guidance as to the disease areas for which the public would value further public and private investment in treatment innovations.

Impact of the COVID-19 Pandemic on Patients Affected by Non-Communicable Diseases in Europe and in the USA.

An international online patient community, Carenity, conducted a patient study in two independent waves among adults affected by non-communicable diseases (NCDs) in Europe and in the United States of America (USA). The study aimed to assess the real time impact of the coronavirus disease 2019 (COVID-19) on the medical conditions of patients with NCDs, their access to health care, and their adaptation to daily life as well as to describe their sources of information on COVID-19 and their needs for specific information and support. During the pandemic, 50% of the patients reported a worsening of their medical condition, and 17% developed a new disease. Additionally, 26% of the respondents reported an impact of the pandemic on regular/long-term treatment intake. 54% of the patients felt very or completely socially isolated and reported a strong impact of the COVID-19 pandemic on their stress level and state of mind, with higher levels observed in the USA compared to Europe. 59% of the respondents wished to have received additional information regarding the risks associated to their medical condition during the pandemic. Television was the most used source of information, whereas physicians were the most trusted one. This study describes the substantial impact of the COVID-19 pandemic on NCD patients.

Using rapid point-of-care tests to inform antibiotic choice to mitigate drug resistance in gonorrhoea.

BackgroundThe first cases of extensively drug resistant gonorrhoea were recorded in the United Kingdom in 2018. There is a public health need for strategies on how to deploy existing and novel antibiotics to minimise the risk of resistance development. As rapid point-of-care tests (POCTs) to predict susceptibility are coming to clinical use, coupling the introduction of an antibiotic with diagnostics that can slow resistance emergence may offer a novel paradigm for maximising antibiotic benefits. Gepotidacin is a novel antibiotic with known resistance and resistance-predisposing mutations. In particular, a mutation that confers resistance to ciprofloxacin acts as the 'stepping-stone' mutation to gepotidacin resistance.AimTo investigate how POCTs detecting Neisseria gonorrhoeae resistance mutations for ciprofloxacin and gepotidacin can be used to minimise the risk of resistance development to gepotidacin.MethodsWe use individual-based stochastic simulations to formally investigate the aim.ResultsThe level of testing needed to reduce the risk of resistance development depends on the mutation rate under treatment and the prevalence of stepping-stone mutations. A POCT is most effective if the mutation rate under antibiotic treatment is no more than two orders of magnitude above the mutation rate without treatment and the prevalence of stepping-stone mutations is 1-13%.ConclusionMutation frequencies and rates should be considered when estimating the POCT usage required to reduce the risk of resistance development in a given population. Molecular POCTs for resistance mutations and stepping-stone mutations to resistance are likely to become important tools in antibiotic stewardship.

Provider and household costs of Plasmodium vivax malaria episodes: a multicountry comparative analysis of primary trial data.

OBJECTIVE: To determine household and health-care provider costs associated with Plasmodium vivax infection across a range of endemic settings. METHODS: We collected cost data alongside three multicentre clinical trials of P. vivax treatment in Afghanistan, Brazil, Colombia, Ethiopia, Indonesia, Philippines, Peru, Thailand and Viet Nam conducted between April 2014 to December 2017. We derived household costs from trial participant surveys administered at enrolment and again 2 weeks later to determine the costs of treatment and transportation, and the number of days that patients and their household caregivers were unable to undertake their usual activities. We determined costs of routine care by health-care providers by micro-costing the resources used to diagnose and treat P. vivax at the study sites. FINDINGS: The mean total household costs ranged from 8.7 United States dollars (US$; standard deviation, SD: 4.3) in Afghanistan to US$ 254.7 (SD: 148.4) in Colombia. Across all countries, productivity losses were the largest household cost component, resulting in mean indirect costs ranging from US$ 5.3 (SD: 3.0) to US$ 220.8 (SD: 158.40). The range of health-care provider costs for routine care was US$ 3.6-6.6. The cost of administering a glucose-6-phosphate-dehydrogenase rapid diagnostic test, ranged from US$ 0.9 to 13.5, consistently lower than the costs of the widely-used fluorescent spot test (US$ 6.3 to 17.4). CONCLUSION: An episode of P. vivax malaria results in high costs to households. The costs of diagnosing and treating P. vivax are important inputs for future cost-effectiveness analyses to ensure optimal allocation of resources for malaria elimination.

Pruritus Is Common and Undertreated in Patients With Primary Biliary Cholangitis in the United Kingdom.

BACKGROUND AND AIMS: Little is known about the prevalence or treatment of pruritus associated with primary biliary cholangitis (PBC). We analyzed data from patients with PBC recruited from all clinical centers in the United Kingdom (UK) to characterize the prevalence, severity, progression, and treatment of pruritus. METHODS: We performed cross-sectional and longitudinal studies of patients in the UK-PBC cohort to assess trajectories of pruritus. Data on pruritus frequency, severity, and therapy were collected via paper questionnaires completed by 2194 patients at their initial assessment in 2011 and then again in 2014 and 2017. Self-reported treatment data were validated against the prescription record of PBC cohort in the Clinical Practice Research Datalink, a primary care database. We defined persistent pruritus as itch that occurs frequently or all the time and severe pruritus as PBC-40 pruritus domain scores of 12 or more, throughout their disease course. Latent class mixed models were used to study pruritus trajectories and identify factors associated with high pruritus. RESULTS: At initial assessment, 1613 (73.5%) patients had experienced pruritus at some point since their development of PBC-persistent pruritus was reported by 34.5% of the patients and severe pruritus by 11.7%. Only 37.4% of patients with persistent pruritus and 50% with severe pruritus reported ever receiving cholestyramine. Frequencies of rifampicin use were 11% in patients with persistent pruritus and 23% in patients with severe pruritus. Comparison of 2011 and 2014 surveys (comprising 1423 patients) showed consistent self-reported data on pruritus. Proportions of patients in the UK-PBC cohort treated with cholestyramine or naltrexone (37.4% and 4.4%) did not differ significantly from proportions treated in the Clinical Practice Research Datalink cohort (30.4% and 4.4%) (P = .07 for cholestyramine and P = .32 for naltrexone). Latent class mixed models (n = 1753) identified 3 different groups of pruritus. Multivariable analysis identified younger age at diagnosis and higher level of alkaline phosphatase at 12 months after diagnosis as factors significantly associated with persistent high pruritus. CONCLUSIONS: In a large national cohort study of patients with PBC, we found a high prevalence of pruritus and inadequate guideline-recommended therapy. Patient-reported data used to determine pruritus prevalence and treatment are reliable. Younger age and levels of higher alkaline phosphatase were associated with persistent pruritus. We need to increase awareness and management of pruritus in PBC in the UK.

BAT117213: Ileal bile acid transporter (IBAT) inhibition as a treatment for pruritus in primary biliary cirrhosis: study protocol for a randomised controlled trial.

BACKGROUND: Pruritus (itch) is a symptom commonly experienced by patients with cholestatic liver diseases such as primary biliary cholangitis (PBC, previously referred to as primary biliary cirrhosis). Bile acids (BAs) have been proposed as potential pruritogens in PBC. The ileal bile acid transporter (IBAT) protein expressed in the distal ileum plays a key role in the enterohepatic circulation of BAs. Pharmacological inhibition of IBAT with GSK2330672 may reduce BA levels in the systemic circulation and improve pruritus. METHODS: This clinical study (BAT117213 study) is sponsored by GlaxoSmithKline (GSK) with associated exploratory studies supported by the National Institute for Health Research (NIHR). It is a phase 2a, multi-centre, randomised, double bind, placebo controlled, cross-over trial for PBC patients with pruritus. The primary objective is to investigate the safety and tolerability of repeat doses of GSK2330672, and explore whether GSK2330672 administration for 14 days improves pruritus compared with placebo. The key outcomes include improvement in pruritus scores evaluated on a numerical rating scale and other PBC symptoms in an electronic diary completed twice daily by the patients. The secondary outcomes include the evaluation of the effect of GSK2330672 on total serum bile acid (BA) concentrations, serum markers of BA synthesis and steady-state pharmacokinetics of ursodeoxycholic acid (UDCA). DISCUSSION: BAT117213 study is the first randomised controlled crossover trial of ileal bile acid transporter inhibitor, a novel class of drug to treat pruritus in PBC. The main strengths of the trial are utility of a novel, study specific, electronic symptom diary as patient reported outcome to measure the treatment response objectively and the crossover design that allows estimating the treatment effect in a smaller number of patients. The outcome of this trial will inform the trial design of future development phase of the IBAT inhibitor drug. The trial will also provide opportunity to conduct metabonomic and gut microbiome studies as explorative and mechanistic research in patients with cholestatic pruritus. TRIAL REGISTRATION: EudraCT number: 2012-005531-84, ClinicalTrials.gov Identifier: NCT01899703 , registered on 3(rd) July 2013.

Cost-Effectiveness of Dolutegravir in HIV-1 Treatment-Naive and Treatment-Experienced Patients in Canada.

INTRODUCTION: The Antiretroviral Analysis by Monte Carlo Individual Simulation (ARAMIS) model was adapted to evaluate the cost-effectiveness of dolutegravir (DTG) in Canada in treatment-naive (TN) and treatment-experienced (TE) human immunodeficiency virus (HIV)-1 patients. METHODS: The ARAMIS-DTG model is a microsimulation model with a lifetime analytic time horizon and a monthly cycle length. Markov health states were defined by HIV health state (with or without opportunistic infection). DTG was compared to efavirenz (EFV), raltegravir (RAL), darunavir/ritonavir, rilpivirine (RPV), elvitegravir/cobicistat, atazanavir/ritonavir and lopinavir/ritonavir in TN patients and to RAL in TE patients. The initial cohort, the main efficacy data and safety data were derived from phase III clinical trials. Treatment algorithms were based on expert opinion. Costs normalized to the year 2013 included antiretroviral treatment cost, testing, adverse event, HIV and cardiovascular disease care and were derived from the literature. RESULTS: Dolutegravir was estimated to be the dominant strategy compared with all comparators in both TN and TE patients. Treatment with DTG was associated with additional quality-adjusted life-years that ranged from 0.17 (vs. RAL) to 0.47 (vs. EFV) in TN patients and was 0.60 in TE patients over a lifetime. Cost savings ranged from Can$1393 (vs. RPV) to Can$28,572 (vs. RAL) in TN patients and amounted to Can$3745 in TE patients. Sensitivity analyses demonstrated the robustness of the model. CONCLUSIONS: Dolutegravir is a dominant strategy in the management of TN and TE patients when compared to recommended comparators. This is mainly related to the high efficacy and high barrier to resistance. FUNDING: ViiV Healthcare.

48-week efficacy and safety of dolutegravir relative to commonly used third agents in treatment-naive HIV-1-infected patients: a systematic review and network meta-analysis.

BACKGROUND: A network meta-analysis can provide estimates of relative efficacy for treatments not directly studied in head-to-head randomized controlled trials. We estimated the relative efficacy and safety of dolutegravir (DTG) versus third agents currently recommended by guidelines, including ritonavir-boosted atazanavir (ATV/r), ritonavir-boosted darunavir (DRV/r), efavirenz (EFV), cobicistat-boosted elvitegravir (EVG/c), ritonavir-boosted lopinavir (LPV/r), raltegravir (RAL), and rilpivirine (RPV), in treatment-naive HIV-1-infected patients. METHODS: A systematic review of published literature was conducted to identify phase 3/4 randomized controlled clinical trials (up to August 2013) including at least one third agent of interest in combination with a backbone nucleoside reverse transcriptase inhibitor (NRTI) regimen. Bayesian fixed-effect network meta-analysis models adjusting for the type of nucleoside reverse transcriptase inhibitor backbone (tenofovir disoproxil fumarate/emtricitabine [TDF/FTC] or abacavir/lamivudine [ABC/3TC]) were used to evaluate week 48 efficacy (HIV-RNA suppression to <50 copies/mL and change in CD4+ cells/µL) and safety (lipid changes, adverse events, and discontinuations due to adverse events) of DTG relative to all other treatments. Sensitivity analyses assessing the impact of NRTI treatment adjustment and random-effects models were performed. RESULTS: Thirty-one studies including 17,000 patients were combined in the analysis. Adjusting for the effect of NRTI backbone, treatment with DTG resulted in significantly higher odds of virologic suppression (HIV RNA<50 copies/mL) and increase in CD4+ cells/µL versus ATV/r, DRV/r, EFV, LPV/r, and RPV. Dolutegravir had better or equivalent changes in total cholesterol, LDL, triglycerides, and lower odds of adverse events and discontinuation due to adverse events compared to all treatments. Random-effects and unadjusted models resulted in similar conclusions. CONCLUSION: Three clinical trials of DTG have demonstrated comparable or superior efficacy and safety to DRV, RAL, and EFV in HIV-1-infected treatment-naive patients. This network meta-analysis suggests DTG is also favorable or comparable to other commonly used third agents (ATV/r, LPV/r, RPV, and EVG/c).

Development and psychometric evaluation of the Bipolar Functional Status Questionnaire (BFSQ).

OBJECTIVES: Persistently impaired psychosocial functioning has been recognized in many individuals with bipolar disorder. However, existing measures of functional disability have been adapted for use in bipolar disorder based mainly on those developed for use in other conditions. The present study involved the development and validation of a new patient self-report measure specific to bipolar disorder, the Bipolar Functional Status Questionnaire (BFSQ). METHODS: Relevant constructs were identified, evaluated, and refined through an expert advisory panel in conjunction with patient interviews. Questionnaire items were vetted through iterative patient interviews. Psychometric properties were determined based on patient responses from implementation of the proposed 33-item questionnaire in an 11-site study of 596 patients with bipolar disorder across varied phases of illness. RESULTS: Eight constructs were identified as fundamental to functional status in bipolar disorder: cognitive function, sleep, role functioning, emotional functioning, energy/vitality, social functioning, personal management, and sexual functioning. Psychometric validation supported item reduction to a 24-item unidimensional scale, with high internal consistency (coefficient alpha's = 0.93-0.95), high test-retest reliability (intraclass correlation coefficient = 0.86, 95% confidence interval = 0.82-0.89), strong convergent validity with other functional disability measures (r's > 0.70), and highly significant discriminant validity across illness phases, with large effect sizes (Cohen's d > 0.70). CONCLUSIONS: The BFSQ is a psychometrically sound self-report measure that can be used to effectively quantify functional status across different clinical states in patients with bipolar disorder.

An extreme bushfire smoke pollution event: health impacts and public health challenges.

AIMS: To determine the health impacts of smoke and the effectiveness of public health advisories during a severe bushfire smoke event in Albury, NSW. METHODS: The NSW Department of Environment and Climate Change provided PM(10) data. A computer-assisted telephone survey using random digit dialling was conducted following the smoke event to assess health impacts and the effectiveness of advisories. RESULTS: The smoke event lasted 38 days. The maximum daily PM(10) level was 415 microg/m(3). Public health advisories were based on alerts for air pollution issued by NSW Department of Health. From the survey, a total of 389 interviews were available for analysis. At least one health effect of the smoke was reported by 70% of respondents and 5% reported seeking medical treatment. Over 74% reported seeing, hearing or reading the health advisories. Behaviour change was significantly greater in this group (odds ratio = 2.74; 95% confidence interval 1.50-5.02). CONCLUSION: High rates of health effects may be experienced by populations exposed to bushfire smoke pollution. Public health advisories can support behaviour change to reduce exposure to bushfire smoke.

Further validation of an individualized migraine treatment satisfaction measure.

OBJECTIVE: To assess individualized satisfaction with migraine treatment, patient expectations, importance rankings, treatment outcomes, and overall satisfaction were combined using a four-part conceptual model. This article describes the measurement properties of the Migraine Treatment Satisfaction Measure (MTSM) using participants from a randomized controlled trial evaluating a Headache Management Program (HMP). METHODS: Participants completed the first two parts of the MTSM upon enrollment and the final two parts at 6 months. Internal consistency reliability was computed within each of the four modules. Discriminant validity was ascertained using Migraine Disability Assessment Survey (MIDAS), Patient Health Questionnaire-9, and MSFB scores. Convergent validity was established by hypothesized positive correlations between MTSM scores, Medical Outcomes Study Short-Form (SF-36), MIDAS, and Migraine Symptom Frequency Bother (MSFB). RESULTS: In total, 124 participants (mean age 45.4 years, 75% women, 59.7% Caucasian) enrolled. Internal consistency for expectations, importance rankings, outcomes, and satisfaction measures was 0.83, 0.95, 0.86, and 0.95, respectively. As the severity of depression increased, MTSM scores decreased significantly. ANOVA between MTSM scores and symptom bothersomeness and symptom frequency tertiles showed a significant decrease in satisfaction in the moderate-to-severe groups. MTSM scores showed expected associations with MSFB scores (-0.301; P < 0.01), MIDAS (-0.267; P < 0.01), general health (0.253; P < 0.05), mental health (0.217; P < 0.05), and vitality subscales of SF-36 (0.214; P < 0.05). Patients in the HMP reported significantly higher MTSM scores (43.2 vs. 31.4; P < 0.001). Patients on triptans reported a significantly higher satisfaction compared to patients on analgesics (39.5 vs. 32.9; P < 0.05). CONCLUSION: The MTSM is a valid and reliable patient-reported outcome that can be used to evaluate differences in treatment satisfaction associated with migraine therapies.

Current status of patient-reported outcomes in industry-sponsored oncology clinical trials and product labels.

Assessing patient-reported outcomes (PROs) in clinical trials is of interest to clinicians, patients, regulators, and industry. The use and impact of PROs is a growing area of methodologic research, particularly as they relate to tumor types, biomarkers, and various patient populations and cultures. Both the US Food and Drug Administration (FDA) and European Agency for the Evaluation of Medicinal Products in recent guidance have acknowledged the need to account for treatment-related impact on patient symptoms and/or health-related quality of life (HRQOL). Clinical research likely reflects the informative value of PROs. A search of www.clinicaltrials.gov, the FDA Web site, and product package inserts was conducted to assess the inclusion of symptom assessment and HRQOL within industry-sponsored clinical trials in cancer and approved cancer therapies and their respective product labels. Overall, there were 2,704 industry-sponsored oncology trials, of which 322 (12%) included a PRO measure. Of the 70 FDA new or revised labels, only six package inserts include PRO data. Symptoms were assessed uniformly across the phases of clinical trials, whereas HRQOL assessment increased in the later phases of clinical trials. Collecting PRO data can enhance our understanding of cancer burden and the impact of interventions on patients' lives.

Evaluating effects of method of administration on Walking Impairment Questionnaire.

BACKGROUND: Intermittent claudication resulting from peripheral arterial disease (PAD) can substantially impair walking function. The Walking Impairment Questionnaire (WIQ) assesses patient self-reported difficulty in walking. Currently this questionnaire is validated for interviewer administration only. Since this can be burdensome in a large clinical trial, we examined the effects of alternative methods of administration on patient responses on the WIQ. METHODS: The WIQ, which consists of four subscales (pain severity, distance, speed, stairs), was modified to be self-administered or interviewer-administered by telephone. Patients with PAD were recruited from two sites and randomized into two groups: in group 1 the WIQ was self-administered, then telephone-administered; in group 2 the WIQ was telephone-administered, then self-administered. The two administrations occurred 4 to 7 days apart. Additional measures (SF-36, EQ-5D, and PAD symptom scale) and clinical data were included to further assess the validity of the WIQ and symptoms in patients with claudication. Telephone interviews were conducted by trained interviewers using standardized scripts. Two-week test-retest reliability was assessed for both the self-administered WIQ (group 1) and the telephone-administered WIQ (group 2). RESULTS: Sixty patients were recruited at two sites (n = 30 per group). Seventy-eight percent were men; mean patient age was 67.1 years; and 83% of patients were white. Mean duration of PAD symptoms was 6.8 years. No significant differences were observed in WIQ subscale scores between self administration and telephone administration. No interaction effects between order and method of administration were detected. Cronbach alpha for distance, speed, and stair-climbing subscales ranged from 0.82 to 0.94. Correlations among WIQ subscales and the symptom scale were good (r = -0.34 to -0.57). Correlations of WIQ subscales with physical health subscales of the SF-36 (r = 0.24-0.59) were higher than for mental health-related subscales (r = 0.08-0.26). CONCLUSIONS: The modified WIQ demonstrated good reliability and validity with both methods of administration. These results suggest that the self-administered and telephone-administered versions of the WIQ can be used reliably and efficiently in clinical trials.