Can prospective usability evaluation predict data errors?

Increasing amounts of clinical research data are collected by manual data entry into electronic source systems and directly from research subjects. For this manual entered source data, common methods of data cleaning such as post-entry identification and resolution of discrepancies and double data entry are not feasible. However data accuracy rates achieved without these mechanisms may be higher than desired for a particular research use. We evaluated a heuristic usability method for utility as a tool to independently and prospectively identify data collection form questions associated with data errors. The method evaluated had a promising sensitivity of 64% and a specificity of 67%. The method was used as described in the literature for usability with no further adaptations or specialization for predicting data errors. We conclude that usability evaluation methodology should be further investigated for use in data quality assurance

A new instrument for measuring anticoagulation-related quality of life: development and preliminary validation

BACKGROUND: Anticoagulation can reduce quality of life, and different models of anticoagulation management might have different impacts on satisfaction with this component of medical care. Yet, to our knowledge, there are no scales measuring quality of life and satisfaction with anticoagulation that can be generalized across different models of anticoagulation management. We describe the development and preliminary validation of such an instrument – the Duke Anticoagulation Satisfaction Scale (DASS). METHODS: The DASS is a 25-item scale addressing the (a) negative impacts of anticoagulation (limitations, hassles and burdens); and (b) positive impacts of anticoagulation (confidence, reassurance, satisfaction). Each item has 7 possible responses. The DASS was administered to 262 patients currently receiving oral anticoagulation. Scales measuring generic quality of life, satisfaction with medical care, and tendency to provide socially desirable responses were also administered. Statistical analysis included assessment of item variability, internal consistency (Cronbach's alpha), scale structure (factor analysis), and correlations between the DASS and demographic variables, clinical characteristics, and scores on the above scales. A follow-up study of 105 additional patients assessed test-retest reliability. RESULTS: 220 subjects answered all items. Ceiling and floor effects were modest, and 25 of the 27 proposed items grouped into 2 factors (positive impacts, negative impacts, this latter factor being potentially subdivided into limitations versus hassles and burdens). Each factor had a high degree of internal consistency (Cronbach's alpha 0.78–0.91). The limitations and hassles factors consistently correlated with the SF-36 scales measuring generic quality of life, while the positive psychological impact scale correlated with age and time on anticoagulation. The intra-class correlation coefficient for test-retest reliability was 0.80. CONCLUSIONS: The DASS has demonstrated reasonable psychometric properties to date. Further validation is ongoing. To the degree that dissatisfaction with anticoagulation leads to decreased adherence, poorer INR control, and poor clinical outcomes, the DASS has the potential to help identify reasons for dissatisfaction (and positive satisfaction), and thus help to develop interventions to break this cycle. As an instrument designed to be applicable across multiple models of anticoagulation management, the DASS could be crucial in the scientific comparison between those models of care

Sexuality talk during adolescent health maintenance visits

IMPORTANCE: Physicians may be important sources of sexuality information and preventive services, and one-on-one confidential time during health maintenance visits is recommended to allow discussions of sexual development, behavior, and risk reduction. However, little is known about the occurrence and characteristics of physician-adolescent discussions about sexuality. OBJECTIVE: To examine predictors of time spent discussing sexuality, level of adolescent participation, and physician and patient characteristics associated with sexuality discussions during health maintenance visits by early and middle adolescents. DESIGN, SETTING, AND PARTICIPANTS: Observational study of audio-recorded conversations between 253 adolescents (mean age, 14.3 years; 53% female; 40% white; 47% African American) and 49 physicians (82% pediatricians; 84% white; 65% female; mean age, 40.9 years; mean [SD] duration in practice, 11.8 [8.7] years) coded for sexuality content at 11 clinics (3 academic and 8 community-based practices) located throughout the Raleigh/Durham, North Carolina, area. MAIN OUTCOMES AND MEASURES: Total time per visit during which sexuality issues were discussed. RESULTS One hundred sixty-five (65%) of all visits had some sexual content within it. The average time of sexuality talk was 36 seconds (35% 0 seconds; 30% 1-35 seconds; and 35% ≥ 36 seconds). Ordinal logistic regression (outcome of duration: 0, 1-35, or ≥ 36 seconds), adjusted for clustering of patients within physicians, found that female patients (odds ratio [OR] = 2.58; 95% CI, 1.53-4.36), older patients (OR = 1.37; 95% CI, 1.13-1.65), conversations with explicit confidentiality discussions (OR = 4.33; 95% CI, 2.58-7.28), African American adolescents (OR = 1.58; 95% CI, 1.01-2.48), and longer overall visit (OR = 1.07; 95% CI, 1.03-1.11) were associated with more sexuality talk, and Asian physicians were associated with less sexuality talk (OR = 0.13; 95% CI, 0.08-0.20). In addition, the same significant associations between adolescent, physician, and visit characteristics were significantly associated with greater adolescent participation. CONCLUSIONS AND RELEVANCE: Our study may be the first to directly observe sexuality talk between physicians and adolescents. We found that one-third of all adolescents had annual visits without any mention of sexuality issues; when sexuality talk occurred, it was brief. Research is needed to identify successful strategies physicians can use to engage adolescents in discussions about sexuality to help promote healthy sexual development and decision making. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01040975

Adult Patients’ Perspectives on the Benefits and Harms of Overused Screening Tests: a Qualitative Study

BACKGROUND: In recent years, there has been a growing interest in reducing the overuse of healthcare services. However, little is known about how patients conceptualize the benefits and harms of overused screening tests or how patients make decisions regarding these tests. OBJECTIVE: To determine how patients think about the harms and benefits of overused screening tests and how they consider these and other factors when making decisions. DESIGN: Semi-structured, qualitative interviews. PARTICIPANTS: The study comprised 50 patients, ages 50-84, who had previously received or not received any of four overused screening services: 1) prostate cancer screening (men ages 50-69), 2) colon cancer screening (men and women ages 76-85), 3) osteoporosis screening (low-risk women ages 50-64), or 4) cardiovascular disease screening (low-risk men and women ages 50-85). APPROACH: We conducted a thematic analysis, using a hybrid inductive-deductive approach. Two independent coders analyzed interview transcriptions to identify themes and exemplifying quotes. KEY RESULTS: Many patients could not name a harm of screening. When they did name harms, patients often focused on only the harms of the screening test itself and rarely mentioned harms further along the screening cascade (e.g., from follow-up testing and treatment). In contrast, patients could easily name benefits of screening, although many seemed to misunderstand or overestimate the magnitude of the benefits. Furthermore, patients described many additional factors they considered when making screening decisions, including their clinicians' recommendations, their age, family or friends' experiences with disease, and insurance coverage. CONCLUSIONS: This study highlights the need to help adults recognize and understand the benefits and harms of screening and make appropriate decisions about overused screening tests

A Comparative Effectiveness Trial of Alternate Formats for Presenting Benefits and Harms Information for Low-Value Screening Services: A Randomized Clinical Trial

Healthcare overuse, the delivery of low-value services, is increasingly recognized as a critical problem. However, little is known about the comparative effectiveness of alternate formats for presenting benefits and harms information to patients as a strategy to reduce overuse. To examine the effect of different benefits and harms presentations on patients' intentions to accept low-value or potentially low-value screening services (prostate cancer screening in men ages 50-69 years; osteoporosis screening in low-risk women ages 50-64 years; or colorectal cancer screening in men and women ages 76-85 years). Randomized clinical trial of 775 individuals eligible to receive information about any 1 of the 3 screening services and scheduled for a visit with their clinician. Participants were randomized to 1 of 4 intervention arms that differed in terms of presentation format: words, numbers, numbers plus narrative, and numbers plus framed presentation. The trial was conducted from September 2012 to June 2014 at 2 family medicine and 2 internal medicine practices affiliated with the Duke Primary Care Research Consortium. The data were analyzed between May and September of 2015. One-page evidence-based decision support sheets on each of the 3 screening services, with benefits and harms information presented in 1 of 4 formats: words, numbers, numbers plus narratives, or numbers plus a framed presentation. The primary outcome was change in intention to accept screening (on a response scale from 1 to 5). Our secondary outcomes included general and disease-specific knowledge, perceived risk and consequences of disease, screening attitudes, perceived net benefit of screening, values clarity, and self-efficacy for screening. We enrolled and randomly allocated 775 individuals, aged 50 to 85 years, to 1 of 4 intervention arms: 195 to words, 192 to numbers, 196 to narrative, and 192 to framed formats. Intentions to accept screening were high before the intervention and change in intentions did not differ across intervention arms (words, -0.07; numbers, -0.05; numbers plus narrative, -0.12; numbers plus framed presentation, -0.02; P = .57 for all comparisons). Change in other outcomes also showed no difference across intervention arms. Results were similar when stratified by screening service. Single, brief, written decision support interventions, such as the ones in this study, are unlikely to be sufficient to change intentions for screening. Alternate and additional interventions are needed to reduce overused screening services. clinicaltrials.gov Identifier: NCT01694784

A feasibility study to develop and test a Spanish patient and provider intervention for managing osteoarthritis in Hispanic/Latino adults (PRIMO-Latino)

Abstract Background Arthritis affects approximately 50 million adults in the USA. Hispanics/Latinos have a higher prevalence of arthritis-attributed activity limitations primarily related to osteoarthritis (OA). Hispanic/Latinos are less likely to receive hip replacement independent of health care access, and they are less likely to receive knee replacement. There have been few interventions to improve OA treatment among the Hispanic/Latino population in the USA. In our study, we aimed to develop and test a telephone delivered culturally appropriate Spanish behavioral intervention for the management of OA in Hispanic/Latino adults. Methods We conducted a feasibility study in an academic health center and local community in Durham, North Carolina. We enrolled self-identified Spanish speaking overweight/obese adults (≥ 18) with OA of the knee and/or hip under the care of a primary health care provider. The 12-month patient intervention focused on physical activity, weight management, and cognitive behavioral pain management skills. The patient intervention was delivered via telephone with calls scheduled twice per month for the first 6 months, then monthly for the last 6 months (18 sessions). The one-time provider intervention included delivery of patient-specific OA treatment recommendations, based on patients’ baseline data and published guidelines. The primary measures were metrics of feasibility, including recruitment and intervention delivery. We also assessed pain, stiffness, and function using the Spanish-Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Results A total of 1879 participants were identified for potential enrollment. Of those, 1864 did not meet inclusion criteria, were not able to be reached or refused. Fifteen participants enrolled in the intervention. The mean number of phone calls completed was 14.7. Eighty percent completed more than 16 calls. The mean WOMAC baseline score (SD) was 39 (20); mean improvement in WOMAC scores between baseline and 12 months, among 11 participants who completed the study, was − 13.27 [95% CI, − 25.09 to − 1.46] points. Conclusion Recruitment of Hispanics/Latinos, continues to be a major challenge. A Spanish-based telephone delivering lifestyle intervention for OA management in Hispanic/Latino adults is feasible to deliver and may lead to improved OA symptoms. Future research is needed to further test the feasibility and effectiveness of this type of intervention in this segment of the population. Trial registration NCT0178241

Situating dissemination and implementation sciences within and across the translational research spectrum

The efficient and effective movement of research into practice is acknowledged as crucial to improving population health and assuring return on investment in healthcare research. The National Center for Advancing Translational Science which sponsors Clinical and Translational Science Awards (CTSA) recognizes that dissemination and implementation (D&I) sciences have matured over the last 15 years and are central to its goals to shift academic health institutions to better align with this reality. In 2016, the CTSA Collaboration and Engagement Domain Task Force chartered a D&I Science Workgroup to explore the role of D&I sciences across the translational research spectrum. This special communication discusses the conceptual distinctions and purposes of dissemination, implementation, and translational sciences. We propose an integrated framework and provide real-world examples for articulating the role of D&I sciences within and across all of the translational research spectrum. The framework\u27s major proposition is that it situates D&I sciences as targeted sub-sciences of translational science to be used by CTSAs, and others, to identify and investigate coherent strategies for more routinely and proactively accelerating research translation. The framework highlights the importance of D&I thought leaders in extending D&I principles to all research stages

Clinic variation in recruitment metrics, patient characteristics and treatment use in a randomized clinical trial of osteoarthritis management

Abstract Background The Patient and PRovider Interventions for Managing Osteoarthritis (OA) in Primary Care (PRIMO) study is one of the first health services trials targeting OA in a multi-site, primary care network. This multi-site approach is important for assessing generalizability of the interventions. These analyses describe heterogeneity in clinic and patient characteristics, as well as recruitment metrics, across PRIMO study clinics. Methods Baseline data were obtained from the PRIMO study, which enrolled n = 537 patients from ten Duke Primary Care practices. The following items were examined across clinics with descriptive statistics: (1) Practice Characteristics, including primary care specialty, numbers and specialties of providers, numbers of patients age 55+, urban/rural location and county poverty level; (2) Recruitment Metrics, including rates of eligibility, refusal and randomization; (3) Participants’ Characteristics, including demographic and clinical data (general and OA-related); and (4) Participants’ Self-Reported OA Treatment Use, including pharmacological and non-pharmacological therapies. Intraclass correlation coefficients (ICCs) were computed for participant characteristics and OA treatment use to describe between-clinic variation. Results Study clinics varied considerably across all measures, with notable differences in numbers of patients age 55+ (1,507-5,400), urban/rural location (ranging from “rural” to “small city”), and proportion of county households below poverty level (12%-26%). Among all medical records reviewed, 19% of patients were initially eligible (10%-31% across clinics), and among these, 17% were randomized into the study (13%-21% across clinics). There was considerable between-clinic variation, as measured by the ICC (>0.01), for the following patient characteristics and OA treatment use variables: age (means: 60.4-66.1 years), gender (66%-88% female), race (16%-61% non-white), low income status (5%-27%), presence of hip OA (26%-68%), presence both knee and hip OA (23%-61%), physical therapy for knee OA (24%-61%) and hip OA (0%-71%), and use of knee brace with metal supports (0%-18%). Conclusions Although PRIMO study sites were part of one primary care practice network in one health care system, clinic and patient characteristics varied considerably, as did OA treatment use. This heterogeneity illustrates the importance of including multiple, diverse sites in trials for knee and hip OA, to enhance the generalizability and evaluate potential for real-world implementation. Trial registration Clinical Trial Registration Number: NCT 0143510