Lauren Nelson

Neighborhood Characteristics, and Child Care Type and Quality

Research Findings: Using data from the Project on Human Development in Chicago Neighborhoods, this article relates neighborhood characteristics to the type of child care used in families with toddlers and preschoolers (N = 1,121; representative of children in Chicago in 1996–1998). Neighborhood structural disadvantage was assessed via U.S. Census data, and neighborhood processes (i.e., density of social networks, collective efficacy, and level of participation in neighborhood organizations) were accessed with a community survey. Child care decisions (i.e., whether they chose care in centers; child care homes by non-relative, by relatives, and exclusively by parents) and the quality of center child care (Early Childhood Environment Rating Scale–Revised) were assessed in a longitudinal sample. After controlling for family characteristics, various neighborhood characteristics were related to child care characteristics. In communities with denser social networks, children were less likely to experience care in child care homes by unrelated adults. Children were more likely to be in child care homes and less likely to cared for by parents exclusively or by relatives when collective efficacy was higher. Center care quality was lower in disadvantaged neighborhoods and higher for publicly funded programs. Further, neighborhood structural disadvantage was more negatively related to quality when mothers had less education. Practice or Policy: These findings provide further evidence that public programs such as Head Start and public pre-kindergarten programs may be especially important to ensure that children living in poverty in disadvantaged neighborhoods have access to the types of child care that promote school readiness.

Development and psychometric evaluation of a new patient-reported outcome instrument measuring the functional impact of insomnia

PurposeThe objective of this study was to develop and validate a patient-reported outcome instrument to comprehensively assess the consequences of inadequate sleep for use in insomnia-related studies.MethodsTo inform item development, relevant constructs were identified through patient focus groups, literature review, and expert input. Following a translatability assessment for United States (US) English, US Spanish, and French, the draft items were refined through iterative sets of patient interviews in the United States and France. Psychometric properties were evaluated using patient responses from a validation study including 432xa0participants with either a diagnosis of primary insomnia or no history of insomnia.ResultsPsychometric analyses supported item reduction from 38 to 26 items, yielding a unidimensional scale and preserving the original content (mood, tiredness/energy, memory/concentration, motivation, daily performance, social interaction, sexual functioning). Evidence of internal consistency (coefficient αxa0=xa00.97), convergent validity, and known-groups validity also was documented.ConclusionsThe Sleep Functional Impact Scale (SFIS) is a psychometrically sound measure targeting the impact of insomnia on patient functioning. When administered with a sleep diary, this instrument has the ability to provide a more comprehensive assessment of treatment response in clinical studies.

Validation of alternate modes of administration of the lung function questionnaire (LFQ) in subjects with smoking history

Purpose: The Lung Function Questionnaire (LFQ) was developed and validated as a case-finding tool to identify patients at risk of airflow obstruction (AO) that should be evaluated further using spirometry. Our objective was to assess the usability and validity of additional questionnaire-administration modes, including Web-based, interactive voice response system (IVRS)-based, and interviewer-based modes. Design: This multicenter, prospective, noninterventional data-collection study enrolled 149 individuals aged ≥40 years with current or former smoking history. A two-visit crossover design was employed; patients completed the paper-based LFQ and were randomly assigned to complete one of three alternate modes. Methods: Statistical evaluation included item-level, scale-level, and AO risk-classification comparisons; a satisfaction survey assessed patient preference. Results: This study showed a great degree of concordance between alternate forms of the LFQ and the paper version. Results indicated an absence of floor and ceiling effects and the average LFQ item-level means were consistent across modes. LFQ scores were stable between assessments, (administered approximately one week apart) showed exceptionally good agreement, and AO risk classification using the LFQ cut point was consistent across modes. Conclusions: The LFQ is an important case-finding tool to aid primary care physicians in further evaluating symptomatic patients at risk of AO. The alternate modes will further facilitate the implementation and widespread uptake of this tool.

Development of the 7-Item Binge-Eating Disorder Screener (BEDS-7)

OBJECTIVEnDevelop a brief, patient-reported screening tool designed to identify individuals with probable binge-eating disorder (BED) for further evaluation or referral to specialists.nnnMETHODSnItems were developed on the basis of the DSM-5 diagnostic criteria, existing tools, and input from 3 clinical experts (January 2014). Items were then refined in cognitive debriefing interviews with participants self-reporting BED characteristics (March 2014) and piloted in a multisite, cross-sectional, prospective, noninterventional study consisting of a semistructured diagnostic interview (to diagnose BED) and administration of the pilot Binge-Eating Disorder Screener (BEDS), Binge Eating Scale (BES), and RAND 36-Item Short-Form Health Survey (RAND-36) (June 2014-July 2014). The sensitivity and specificity of classification algorithms (formed from the pilot BEDS item-level responses) in predicting BED diagnosis were evaluated. The final algorithm was selected to minimize false negatives and false positives, while utilizing the fewest number of BEDS items.nnnRESULTSnStarting with the initial BEDS item pool (20 items), the 13-item pilot BEDS resulted from the cognitive debriefing interviews (n = 13). Of the 97 participants in the noninterventional study, 16 were diagnosed with BED (10/62 female, 16%; 6/35 male, 17%). Seven BEDS items (BEDS-7) yielded 100% sensitivity and 38.7% specificity. Participants correctly identified (true positives) had poorer BES scores and RAND-36 scores than participants identified as true negatives.nnnCONCLUSIONSnImplementation of the brief, patient-reported BEDS-7 in real-world clinical practice is expected to promote better understanding of BED characteristics and help physicians identify patients who may have BED.

Psychometric validation of patient-reported outcome measures assessing chronic constipation

Background Measures assessing treatment outcomes in previous CC clinical trials have not met the requirements described in the US Food and Drug Administration’s guidance on patient-reported outcomes. Aim Psychometric analyses using data from one Phase IIb study and two Phase III trials of linaclotide for the treatment of chronic constipation (CC) were conducted to document the measurement properties of patient-reported CC Symptom Severity Measures. Study methods Each study had a multicenter, randomized, double-blind, placebo-controlled, parallel-group design, comparing placebo to four doses of oral linaclotide taken once daily for 4 weeks in the Phase IIb dose-ranging study (n=307) and to two doses of linaclotide taken once daily for 12 weeks in the Phase III trials (n=1,272). The CC Symptom Severity Measures addressing bowel function (Bowel Movement Frequency, Stool Consistency, Straining) and abdominal symptoms (Bloating, Abdominal Discomfort, Abdominal Pain) were administered daily using interactive voice-response system technology. Intraclass correlations, Pearson correlations, factor analyses, F-tests, and effect sizes were computed. Results The CC Symptom Severity Measures demonstrated satisfactory test–retest reliability and construct validity. Factor analyses indicated one factor for abdominal symptoms and another for bowel symptoms. Known-groups F-tests substantiated the discriminating ability of the CC Symptom Severity Measures. Responsiveness statistics were moderate to strong, indicating that these measures are capable of detecting change. Conclusion In large studies of CC patients, linaclotide significantly improved abdominal and bowel symptoms. These psychometric analyses support the reliability, validity, discriminating ability, and responsiveness of the CC Symptom Severity Measures for evaluating treatment outcomes in the linaclotide clinical studies.

Long-term health-related quality-of-life and symptom response profiles with arformoterol in COPD: Results from a 52-week trial

Background Symptom severity is the largest factor in determining subjective health in COPD. Symptoms (eg, chronic cough, dyspnea) are associated with decreased health-related quality of life (HRQoL). We evaluated the impact of arformoterol on HRQoL in COPD patients, measured by St George’s Respiratory Questionnaire (SGRQ). Post hoc growth mixture model (GMM) analysis examined symptom response profiles. Methods We examined data from a randomized, double-blind, parallel-group, 12-month safety trial of twice-daily nebulized arformoterol 15 µg (n=420) versus placebo (n=421). COPD severity was assessed by Global Initiative for Chronic Obstructive Lung Disease (GOLD) status. GMM analysis identified previously unknown patient subgroups and examined the heterogeneity in response to SGRQ Symptoms scores. Results SGRQ Total score improved by 4.24 points with arformoterol and 2.02 points with placebo (P=0.006). Significantly greater improvements occurred for arformoterol versus placebo in SGRQ Symptoms (6.34 vs 4.25, P=0.031) and Impacts (3.91 vs 0.97, P=0.001) scores, but not in Activity score (3.57 vs 1.75, P=0.057). GMM identified responders and nonresponders based on the SGRQ Symptoms score. End-of-study mean difference in SGRQ Symptoms scores between these latent classes was 20.7 points (P<0.001; 95% confidence interval: 17.6–23.9). Compared with nonresponders, responders were more likely current smokers (55.52% vs 44.02%, P=0.0021) and had more severe COPD (forced expiratory volume in 1 second [FEV1]: 1.16 vs 1.23 L, P=0.0419), more exacerbations (0.96 vs 0.69, P=0.0018), and worse mean SGRQ Total (59.81 vs 40.57, P<0.0001), Clinical COPD Questionnaire (3.29 vs 2.05, P<0.0001), and Modified Medical Research Council Dyspnea Scale (3.13 vs 2.75, P<0.0001) scores. Arformoterol-receiving responders exhibited significantly greater improvements in FEV1 (0.09 vs 0.008, P=0.03) and fewer hospitalizations (0.13 vs 0.24, P=0.02) than those receiving placebo. Conclusion In this study, arformoterol treatment significantly improved HRQoL reflected by SGRQ. For the analysis performed on these data, arformoterol may be particularly effective in improving lung function and reducing hospitalizations among patients who are unable to quit smoking or present with more severe symptoms.

Use and value of the 7-item binge eating disorder screener in clinical practice

ObjectivenTo evaluate physician knowledge of and attitudes about binge-eating disorder (BED) and the value and ease-of-use of the 7-item Binge Eating Disorder Screener (BEDS-7) in clinical practice.nnnMethodsnTwo internet surveys (wave 1: April 15-May 6, 2015; wave 2: August 19-25, 2015) were administered to primary care physicians serving adults (PCPs-adults) and psychiatrists. Wave 1 invitees were US-based physicians spending ≥ 50% of their time in direct patient care and reporting no to some to average experience with eating-disorder patients. Respondents completing wave 1 qualified for wave 2.nnnResultsnAmong the 1,047 physicians who responded, 313 did not meet at least 1 of the screening criteria, including 3.15% of respondents who spent < 50% of their time in direct patient care. Overall, 122 PCPs-adults and 123 psychiatrists completed both waves. Physician groups spent similar mean ± SD amounts of time providing direct patient care (PCPs-adults: 94.66% ± 8.4%, psychiatrists: 91.15% ± 12.2%). Based on composite scores, BED knowledge increased from wave 1 to wave 2 in PCPs-adults (P < .001) and psychiatrists (P < .05). Composite scores pertaining to knowledge of and comfort with diagnosing and treating BED were lower for PCPs-adults than psychiatrists in both waves (all P < .001). Based on wave 2 responses, the BEDS-7 was used by 32.0% of PCPs-adults and 26.8% of psychiatrists. All BEDS-7 users (100%) indicated the screener was very or somewhat valuable, and nearly all users (psychiatrists: 100%, PCPs-adults: 97.4%) reported it was very or reasonably easy to use. BEDS-7 users reported that important uses of the screener included assisting clinicians in identifying BED patients and encouraging/initiating doctor-patient discussions about BED.nnnConclusionsnThese results support the utility of the BEDS-7 in clinical practice, with BEDS-7 users reporting that it is a highly valued and easy-to-use screener. Furthermore, both PCPs-adults and psychiatrists acknowledged the importance of being knowledgeable about BED.