Development and validation of the patient-reported outcome for older people living with HIV/AIDS in China (PROHIV-OLD).

BACKGROUND: The involvement of quality of life as the UNAIDS fourth 90 target to monitor the global HIV response highlighted the development of patient-reported outcome (PRO) measures to help address the holistic needs of people living with HIV/AIDS (PLWHA) beyond viral suppression. This study developed and tested preliminary measurement properties of a new patient-reported outcome (PROHIV-OLD) measure designed specifically to capture influences of HIV on patients aged 50 and older in China. METHODS: Ninety-three older people living with HIV/AIDS (PLWHA) were interviewed to solicit items and two rounds of patient cognitive interviews were conducted to modify the content and wording of the initial items. A validation study was then conducted to refine the initial instrument and evaluate measurement properties. Patients were recruited between February 2021 and November 2021, and followed six months later after the first investigation. Classical test theory (CTT) and item response theory (IRT) were used to select items using the baseline data. The follow-up data were used to evaluate the measurement properties of the final instrument. RESULTS: A total of 600 patients were recruited at the baseline. Of the 485 patients who completed the follow-up investigation, 483 were included in the validation sample. The final scale of PROHIV-OLD contained 25 items describing five dimensions (physical symptoms, mental status, illness perception, family relationship, and treatment). All the PROHIV-OLD dimensions had satisfactory reliability with Cronbach's alpha coefficient, McDonald's ω, and composite reliability of each dimension being all higher than 0.85. Most dimensions met the test-retest reliability standard except for the physical symptoms dimension (ICC = 0.64). Confirmatory factor analysis supported the structural validity of the final scale, and the model fit index satisfied the criterion. The correlations between dimensions of PROHIV-OLD and MOS-HIV met hypotheses in general. Significant differences on scores of the PROHIV-OLD were found between demographic and clinical subgroups, supporting known-groups validity. CONCLUSIONS: The PROHIV-OLD was found to have good feasibility, reliability and validity for evaluating health outcome of Chinese older PLWHA. Other measurement properties such as responsiveness and interpretability will be further examined.

Developmental Risk for Infants with Cleft Lip with or Without Cleft Palate Based on Caregiver-Proxy Reports.

OBJECTIVES: (1) Assess caregiver-reported development in infants born with cleft lip ± alveolus (CL ± A) and cleft lip and palate (CLP); (2) determine factors associated with increased developmental risk; and (3) determine consistency of developmental risk before and after surgery for cleft lip. DESIGN: Prospective, longitudinal assessment of development. Time (T) 1, prior to lip closure; T2, 2 months post lip closure. SETTING: Three US craniofacial teams and online parent support groups. PARTICIPANTS: 123 total caregivers (96% mothers); 100 at T1, 92 at T2, and 69 at both T1 and T2. MEASURE: Ages and Stages Questionnaire-3 (ASQ-3): Communication, Gross Motor, Fine Motor, Problem Solving, Personal Social Domains. RESULTS: At T1 47%; at T2 42% passed all 5 Domains; 36% of infants pass all 5 Domains at both T1 and T2. Infants with CLP were at greatest risk on Communication [B = 1.449 (CI = .149-20.079), p = .038; Odds Ratio (OR) = 4.3 (CI = .923-19.650)] and Gross Motor Domains [B = 1.753 (CI = .316-20.605), p = .034; OR = 5.8 (CI = 1.162-28.671)]. Male infants were at greatest risk on Fine Motor [B = 1.542 (CI = .495-20.005), p = .009; OR = 4.7 (CI = 1.278-17.101)] and Problem Solving Domains [B = 1.200 (CI = .118-19.708), p = .044; OR = 3.3 (CI = .896-12.285)]. CONCLUSIONS: Based on caregiver report, infants with CL ± A and CLP meet referral criteria at a high rate. Infants with CLP and male infants were at greatest risk. Regular developmental screening is recommended.

Quality assessment of patient-reported outcome measures for patients with multiple ear complaints.

INTRODUCTION: There is an increased demand for well-validated PROMs in otology. This study will systematically assess the methodological quality of all published patient-reported outcome measures (PROMS) for patients with multiple ear complaints and to identify the best suitable PROM for use by clinicians treating patients with multiple ear complaints. METHODS: An extensive systematic mapping review of all otology questionnaires was performed to identify questionnaires measuring multiple ear complaints. The 'Consensus-based standards for the selection of health measurement Instruments' (COSMIN) checklists were used to evaluate the quality of the questionnaire by two researchers. The worst item score per aspect of the methodological assessment counted. RESULTS: Twelve multiple-complaint questionnaires were included in the study for quality assessment. Ten questionnaires were disease-specific (COMQ-12, CES, ZCMEI-21, MD-POSI, PAN-QOL, ETDQ-7, MDOQ, GYSSCDQ, COMOT-15 and DEU-MDDS). Two questionnaires were ear domain-specific (OQUA and COQOL). The majority of multiple complaint questionnaires lacked good design with concept elicitation and patient involvement. CONCLUSION: For the majority of questionnaires, the quality assessment was inadequate as only a few authors consulted with patients affected by the complaints in the development. Modifications of earlier versions of PROMS or combinations of multiple questionnaires lead to ongoing (cross-cultural) validation of these questionnaires albeit mediocre design and validation. The two domain-specific questionnaires are the COQOL and OQUA, both with adequate quality but different focus. COQOL to quantify the quality of life and OQUA to measure and evaluate the severity and impact of ear complaints. [Correction added on 26 January 2024, after first online publication: In the preceding sentence, the spelling of the abbreviation COQOL has been corrected in this version.].

Observations by Caregivers Using the Infant with Clefts Observation Outcomes Instrument (iCOO): A Comparison of Three Versus Seven-day Daily Diaries.

OBJECTIVE: Our goal was to compare data collected from 3- and 7-day Infant with Clefts Observation Outcomes (iCOO) diaries. DESIGN: Secondary data analysis of an observational longitudinal cohort study. Caregivers completed the daily iCOO for 7 days before cleft lip surgery (T0) and for 7 days after cleft lip repair (T1). We compared 3- and 7-day diaries collected at T0 and 3- and 7-day diaries collected at T1. SETTING: United States. PARTICIPANTS: Primary caregivers of infants with cleft lip with and without cleft palate (N = 131) planning lip repair and enrolled in original iCOO study. MAIN OUTCOMES MEASURE(S): Mean differences and Pearson correlation coefficients. RESULTS: Correlation coefficients were high for global impressions (>0.90) and scaled scores (0.80-0.98). Mean differences were small across iCOO domains at T0. T1 comparisons reflected the same pattern. CONCLUSIONS: Three-day diary data is comparable to 7-day diaries for measuring caregiver observations using iCOO across T0 and T1.

Exploration of Caregiver Interrater Agreement and Test-Retest Reliability on the Infant Cleft Observer Outcomes (iCOO).

Caregiver and observer-reported measures are frequently used as outcomes for research on infants and young children who are unable to report on their own health. Our team developed the Infant with Clefts Observation Outcomes Instrument (iCOO) for infants with cleft lip with or without cleft palate. This exploratory study compared test-retest and interrater reliabilities to inform whether differences in caregiver perspective might affect the iCOO.This study is a secondary analysis comparing caregiver interrater agreement to test-retest reliability. Twenty-five pairs of caregivers completed the iCOO before surgery, 1 week later for test-retest reliability, 2 days after surgery, and 2 months after surgery. Reliability was assessed using intraclass correlations (ICCs) and t-tests were used to compare ratings between caregivers.Infants had cleft lip (28%) or cleft lip and palate (72%). Primary caregivers were predominantly mothers (92%) and secondary caregivers were predominantly fathers (80%). Test-retest reliability met psychometric standards for most items on the iCOO (81%-86% of items). Caregiver agreement on the iCOO items was lower than test-retest reliability (33%-46% of items met psychometric standards). Caregivers did not systematically differ in whether they rated infants as healthier or less healthy than the other caregiver (5%-16% of items had statistically significant differences).Caregivers used the measure consistently, but had different experiences and perceptions of their infant's health and functioning. Future studies are needed to explore mechanisms for the differences in test-retest and interrater reliability. Whenever possible, the same caregiver should provide ratings of the infant, including on the iCOO.

Patient-reported outcomes associated with cancer screening: a systematic review.

BACKGROUND: Multi-cancer early detection tests have been developed to enable earlier detection of multiple cancer types through screening. As reflected by patient-reported outcomes (PROs), the psychosocial impact of cancer screening is not yet clear. Our aim is to evaluate the impact of cancer screening through PRO assessment. METHODS: A systematic review was conducted using MEDLINE, EMBASE, and reference lists of articles from January 2000 to August 2020 for relevant publications assessing the psychosocial impact of cancer screening before and within 1 year after screening in the general asymptomatic population, including following receipt of results. Studies focused on diagnostic evaluation or involving patients previously diagnosed with cancer were excluded. RESULTS: In total, 31 studies (12 randomized controlled trials; 19 observational studies) were included, reflecting PRO assessments associated with lung, breast, colorectal, anal, ovarian, cervical, and prostate cancer screening procedures. The most commonly assessed construct was symptoms of anxiety, using the State-Trait Anxiety Inventory. Cancer-specific distress and worry were also assessed using a broad range of measures. Overall, individuals tolerated screening procedures well with no major psychosocial effects. Of note, increases in symptoms of anxiety and levels of distress and worry were generally found prior to communication of screening results and following communication of indeterminate or positive results that required further testing. These negative psychosocial effects were, however, not long-lasting and returned to baseline relatively soon after screening. Furthermore, individuals with higher cancer risk, such as current smokers and those with a family history of cancer, tended to have higher levels of anxiety and distress throughout the screening process, including following negative or indeterminate results. CONCLUSIONS: The psychosocial impact of cancer screening is relatively low overall and short-lived, even following false-positive test results. Individuals with a higher risk of cancer tend to experience more symptoms of anxiety and distress during the screening process; thus, more attention to this group is recommended.

Infant with Clefts Observation Outcomes Instrument (iCOO): A New Outcome for Infants and Young Children with Orofacial Clefts.

OBJECTIVE: We evaluated the measurement properties for item and domain scores of the Infant with Clefts Observation Outcomes Instrument (iCOO). DESIGN: Cross-sectional (before lip surgery) and longitudinal study (preoperative baseline and 2 days and 2 months after lip surgery). SETTING: Three academic craniofacial centers and national online advertisements. PARTICIPANTS: Primary caregivers with an infant with cleft lip with or without cleft palate (CL ± P) scheduled to undergo primary lip repair. There were 133 primary caregivers at baseline, 115 at 2 days postsurgery, and 112 at 2 months postsurgery. MAIN OUTCOME MEASURE(S): Caregiver observation items (n = 61) and global impression of health and function items (n = 8) across eight health domains. RESULTS: Mean age at surgery was 6.0 months (range 2.7-11.8 months). Five of eight iCOO domains have scale scores, with Cronbach's alphas ranging from 0.67 to 0.87. Except for the Facial Skin and Mouth domain, iCOO scales had acceptable intraclass correlation coefficients (ICCs) ranging from 0.76 to 0.84. The internal consistency of the Global Impression items across all domains was 0.90 and had acceptable ICCs (range 0.76-0.91). Sixteen out of 20 (nonscale) items had acceptable ICCs (range 0.66-0.96). As anticipated, iCOO scores 2 days postoperatively were generally lower than baseline and scores 2 months postsurgery were consistent with baseline or higher. The iCOO took approximately 10 min to complete. CONCLUSIONS: The iCOO meets measurement standards and may be used for assessing the impact of cleft-related treatments in clinical research and care. More research is needed on its use in various treatment contexts.

Caregiver Observations of Infant Well-Being Before and After Cleft Lip Surgery.

OBJECTIVE: To evaluate the sensitivity to change of daily ratings of the comfort (COMF) and behavioral/emotional health (BEH) domains of the Infants with Clefts Observation Outcomes Instrument (iCOO) at 3 time points, and to assess the association of post-surgical interventions on iCOO ratings. DESIGN: The COMF and BEH domains were completed by caregivers before (T0), immediately after (T1), and 2-months after (T2) cleft lip (CL) surgery. Analyses included descriptive statistics, correlations, t-tests, and generalized estimating equations. PARTICIPANTS: Caregivers (N = 140) of infants with CL with/without cleft palate. MAIN OUTCOME MEASURES: The COMF and BEH domain scores of the iCOO: Scale (SCALE), a summary of observable signs; and Global Impression (IMPR), a single item measuring caregivers' overall impression. RESULTS: Daily COMF and BEH SCALE and IMPR scores changed significantly during T1 (P's < 0.001) but not T0 or T2. Day 1 and 7 T0 scores were significantly higher than Day 1 and 7 T1 scores (P's <0.001 to <0.012) but similar at T2 (P's > 0.05). After CL surgery, the combined use of immobilizers and nasal stents and the use of multiple feeding methods with treatment for gastroesophageal reflux were associated with lower daily scores in COMF and BEH SCALE and IMPR (P's: 0.040 to <0.001). CONCLUSIONS: COMF and BEH iCOO scores were sensitive to daily changes in infant well-being following CL surgery. Future studies should further investigate impact of post-surgical treatments on infant well-being.

Detecting response shift in health-related quality of life measurement among patients with hypertension using structural equation modeling.

BACKGROUND: Outcomes derived from longitudinal self-reported health-related quality of life measures can be confounded by response shift. This study was aimed to detect response shift among patients with hypertension attending a community-based disease management program. METHODS: 240 consecutive consulting or follow-up patients with diagnosed hypertension were recruited. The Short Form 36-item Health Survey was self-administered at 12 community health service stations at baseline and four weeks after attending the program. The 4-step structural equation modeling approach assessed response shift. RESULTS: Data from 203 (84.6%) patients were eligible for analyses (mean age 65.9 ± 10.8 years, 46.3% female). The results showed uniform recalibration of social functioning ([Formula: see text](1) = 22.98, P < 0.001), and non-uniform recalibration of role limitations due to physical problems ([Formula: see text](1) = 8.84, P = 0.003), and bodily pain ([Formula: see text](1) = 17.41, P < 0.001). The effects of response shift on social functioning were calculated as "small" (effect-size = 0.35), but changed the observed changes from improvement (effect-size = 0.25) to slight deterioration (effect-size = -0.10). After accounting for the response shift effect, the general physical health of participants was improved (effect-size = 0.37), while deterioration (effect-size = -0.21) in the general mental health was also found. CONCLUSIONS: Recalibration existed among patients with hypertension attending the disease management program. The interventions in the program might act as a catalyst that induced the response shift. We conclude that response shift should be considered in hypertension research with longitudinal health-related quality of life data.

Criteria and Process for Initiating and Developing an ISPOR Good Practices Task Force Report.

The International Society for Pharmacoeconomics and Outcomes Research (ISPOR)'s "Good Practices Task Force" reports are highly cited, multistakeholder perspective expert guidance reports that reflect international standards for health economics and outcomes research (HEOR) and their use in healthcare decision making. In this report, we discuss the criteria, development, and evaluation/consensus review and approval process for initiating a task force. The rationale for a task force must include a justification, including why this good practice guidance is important and its potential impact on the scientific community. The criteria include: (1) necessity (why is this task force required?); (2) a methodology-oriented focus (focus on research methods, approaches, analysis, interpretation, and dissemination); (3) relevance (to ISPOR's mission and its members); (4) durability over time; (5) broad applicability; and 6) an evidence-based approach. In addition, the proposal must be a priority specifically for ISPOR. These reports are valuable to researchers, academics, students, health technology assessors, medical technology developers and service providers, those working in other commercial entities, regulators, and payers. These stakeholder perspectives are represented in task force membership to ensure the report's overall usefulness and relevance to the global ISPOR membership. We hope that this discussion will bring transparency to the process of initiating, approving, and producing these task force reports and encourage participation from a diverse range of experts within and outside ISPOR.

Defining Patient Engagement in Research: Results of a Systematic Review and Analysis: Report of the ISPOR Patient-Centered Special Interest Group.

OBJECTIVES: Lack of clarity on the definition of "patient engagement" has been highlighted as a barrier to fully implementing patient engagement in research. This study identified themes within existing definitions related to patient engagement and proposes a consensus definition of "patient engagement in research." METHODS: A systematic review was conducted to identify definitions of patient engagement and related terms in published literature (2006-2018). Definitions were extracted and qualitatively analyzed to identify themes and characteristics. A multistakeholder approach, including academia, industry, and patient representation, was taken at all stages. A proposed definition is offered based on a synthesis of the findings. RESULTS: Of 1821 abstracts identified and screened for eligibility, 317 were selected for full-text review. Of these, 169 articles met inclusion criteria, from which 244 distinct definitions were extracted for analysis. The most frequently defined terms were: "patient-centered" (30.5%), "patient engagement" (15.5%), and "patient participation" (13.4%). The majority of definitions were specific to the healthcare delivery setting (70.5%); 11.9% were specific to research. Among the definitions of "patient engagement," the most common themes were "active process," "patient involvement," and "patient as participant." In the research setting, the top themes were "patient as partner," "patient involvement," and "active process"; these did not appear in the top 3 themes of nonresearch definitions. CONCLUSION: Distinct themes are associated with the term "patient engagement" and with engagement in the "research" setting. Based on an analysis of existing literature and review by patient, industry, and academic stakeholders, we propose a scalable consensus definition of "patient engagement in research."

Familism, Self-Esteem, and Weight-Specific Quality of Life Among Latinx Adolescents With Obesity.

OBJECTIVE: Obesity is a critical public health condition affecting Latinx adolescents and contributes to health disparities across the lifespan. Childhood and adolescent obesity is associated with reduced quality of life (QoL) and decreased self-esteem. The purpose of this study is to examine the role of cultural (e.g., familism) and psychosocial (e.g., self-esteem) factors as predictors of weight-specific QoL among Latinx adolescents with obesity. METHODS: Baseline data from 160 Latinx adolescents (ages 14-16 years) with obesity (BMI > 95th percentile for age and sex) who were recruited for a diabetes prevention intervention were used. Structural equation modeling tested the relationships between four latent constructs (familism, positive self-esteem, self-deprecation, and weight-specific QoL). RESULTS: The model tested paths from familism to positive self-esteem, self-deprecation, and weight-specific QoL, and paths from positive self-esteem and self-deprecation to weight-specific QoL. Higher familism was positively associated with positive self-esteem but not self-deprecation. In turn, positive self-esteem was positively associated with higher weight-specific QoL, whereas self-deprecation was negatively associated. Furthermore, there was an indirect effect of familism on QoL via positive self-esteem. CONCLUSIONS: These data shed light into specific cultural and psychosocial constructs that influence QoL among Latinx adolescents with obesity. This study suggests that familism and positive self-esteem can operate as protective factors associated with higher weight-specific QoL in Latinx adolescents with obesity; whereas self-deprecation may operate as a risk factor for lower weight-specific QoL.

Development of an Outcome Measure of Observable Signs of Health and Well-Being in Infants With Orofacial Clefts.

OBJECTIVE: To develop an outcomes instrument that assesses observations that can be reliably reported by caregivers and can be used to assess health of infants with a cleft lip or cleft lip and cleft palate (CL±P) and impacts of treatments. DESIGN: Cross-sectional, mixed methods study. SETTING: Caregivers and health-care providers were recruited from 3 academic craniofacial centers and national advertisements. Most interviews were conducted by telephone, and surveys were completed online. PARTICIPANTS: Caregivers had a child less than 3 years of age with CL±P and spoke either English or Spanish. Health-care providers were members of a cleft team. Caregivers (n = 492) and health-care professionals (n = 75) participated in at least one component of this study. MAIN OUTCOME MEASURE(S): Caregivers and health-care providers participated in tasks related to instrument development: concept elicitation for items within relevant health domains, prioritization of items, and item review. RESULTS: We identified 295 observations of infant well-being across 9 health areas. Research staff and specialists evaluated items for clarity, specificity to CL±P, and responsiveness to treatment. Caregivers and health-care providers rated the resulting list of 104 observations and developed the final instrument of 65 items. CONCLUSIONS: In this phase of development of the Infant with Clefts Observation Outcomes (iCOO) instrument, items were developed to collect caregiver observations about indicators of children's health and well-being across multiple domains allowing for psychometric testing, sensitivity to changes associated with treatment, and documentation of the effects of treatment.

Role of Family Obligation Stress on Ugandan Women's Participation in Preventive Breast Health.

BACKGROUND: The purpose of this study is to determine the role of family obligation stress on Ugandan women's participation in preventive breast health through the receipt of breast cancer education and health check-ups. MATERIALS AND METHODS: A validated survey was conducted on a community sample of Ugandan women, providing a multi-item scale to assess preventive breast-health-seeking behaviors and measure family obligation stress (FO; range 6-18). Univariate and multivariate linear regression was used to assess associations between sociodemographic factors and FO. Univariate and multivariate linear regression (used in conjunction with the robust sandwich estimator for standard errors) and probability differences (PDs) were used to evaluate associations between preventive breast-health-seeking behaviors, sociodemographic factors, and FO. RESULTS: A total of 401 Ugandan women ages 25-74 participated in the survey. Most had three or more children in the home (60%) and were employed full time (69%). Higher FO was associated with increasing number of children and/or adults in the household (p < .05), full-time employment (p < .001), and being single (p = .003). Women with higher FO were less likely to participate in breast cancer education (PD = -0.02 per 1-point increase, p = .008) and preventive health check-ups (PD = -0.02, p = .018), associations that persisted on multivariate analysis controlling for sociodemographic factors. CONCLUSION: Ugandan women with high FO are less likely to participate in preventive breast cancer detection efforts including breast cancer education and preventive health check-ups. Special efforts should be made to reach women with elevated FO, because it may be a risk factor for late-stage presentation among women who develop breast cancer. IMPLICATIONS FOR PRACTICE: High family obligation stress (FO) significantly reduces women's participation in preventive health check-ups and breast cancer education. These findings support research in U.S. Latinas showing high FO negatively affects women's health, suggesting that FO is an important factor in women's health-seeking behavior in other cultures. Addressing family obligation stress by including family members involved in decision-making is essential for improving breast cancer outcomes in low- and middle-income countries, such as Uganda.

Psychological outcomes related to exome and genome sequencing result disclosure: a meta-analysis of seven Clinical Sequencing Exploratory Research (CSER) Consortium studies.

PURPOSE: As exome and genome sequencing (ES/GS) enters the clinic, there is an urgent need to understand the psychological effects of test result disclosure. Through a Clinical Sequencing Exploratory Research (CSER), phase 1 (CSER1) Consortium collaboration, we evaluated participants' psychological outcomes across multiple clinical settings. METHODS: We conducted a random effects meta-analysis of state anxiety (Hospital Anxiety and Depression Scale [HADS]/Generalized Anxiety Disorder 7-item), depressive symptoms (HADS/Personal Health Questionnaire 9-item), and multidimensional impact (i.e., test-related distress, uncertainty and positive impact: modified Multidimensional Impact of Cancer Risk Assessment/Feelings About Genomic Testing Results scale). RESULTS: Anxiety and depression did not increase significantly following test result disclosure. Meta-analyses examining mean differences from pre- to postdisclosure revealed an overall trend for a decrease in participants' anxiety. We observed low levels of test-related distress and perceptions of uncertainty in some populations (e.g., pediatric patients) and a wide range of positive responses. CONCLUSION: Our findings across multiple clinical settings suggest no clinically significant psychological harms from the return of ES/GS results. Some populations may experience low levels of test-related distress or greater positive psychological effects. Future research should further investigate the reasons for test-related psychological response variation.

Development and initial validation of the chronic hepatitis B quality of life instrument (CHBQOL) among Chinese patients.

PURPOSE: This study developed and tested preliminary measurement properties of a Chinese scale specifically designed to measure HRQOL in patients with chronic hepatitis B (CHBQOL). METHODS: We conducted 94 individual interviews with CHB patients to solicit items and five hepatitis expert interviews along with three rounds of cognitive interviews to identify problems with relevance and understanding of content. A cross-sectional validation study was then conducted to evaluate measurement properties (n = 578). Factor analysis was used to determine the latent structure of the scale. Reliability was evaluated through Cronbach's alpha coefficients and intra-class correlation coefficients (ICCs). Measurement model adequacy, convergent, discriminant, and known-groups validity were also examined. RESULTS: A scale of 30 items was drafted. After item reduction, the remaining 23 items were assigned to the CHBQOL Somatic symptoms, Emotional symptoms, Belief and Social stigma domains, which had acceptable goodness of fit (χ2/df = 3.13, GFI = 0.90, AGFI = 0.88, RMSEA = 0.06, SRMR = 0.05). All the CHBQOL domains had satisfactory reliability with Cronbach's α coefficients ranging from 0.73 to 0.91 and ICCs were higher than 0.70 except for Belief domain (ICC = 0.54). Convergent and discriminant validity were acceptable as supported by significant item-domain correlations (0.64-0.90). In general, the correlations between CHBQOL and the SF-36 dimensions met hypotheses. Significant differences were found by mean scores in the subgroups of demographic and clinical variables, supporting the known-groups validity. CONCLUSIONS: The CHBQOL instrument proved to be an appropriate tool for assessing HRQOL among Chinese CHB patients.

The Feelings About genomiC Testing Results (FACToR) Questionnaire: Development and Preliminary Validation.

The purpose of this study was to develop a brief instrument, the Feelings About genomiC Testing Results (FACToR), to measure the psychosocial impact of returning genomic findings to patients in research and clinical practice. To create the FACToR, we modified and augmented the Multidimensional Impact of Cancer Risk Assessment (MICRA) questionnaire based on findings from a literature review, two focus groups (N = 12), and cognitive interviews (N = 6). We evaluated data from 122 participants referred for evaluation for inherited colorectal cancer or polyposis from the New EXome Technology in (NEXT) Medicine Study, an RCT of exome sequencing versus usual care. We assessed floor and ceiling effects of each item, conducted principal component analysis to identify subscales, and evaluated each subscale's internal consistency, test-retest reliability, and construct validity. After excluding items that were ambiguous or demonstrated floor or ceiling effects, 12 items forming four distinct subscales were retained for further analysis: negative emotions, positive feelings, uncertainty, and privacy concerns. All four showed good internal consistency (0.66-0.78) and test-retest reliability (0.65-0.91). The positive feelings and the uncertainty subscales demonstrated known-group validity. The 12-item FACToR with four subscales shows promising psychometric properties on preliminary evaluation in a limited sample and needs to be evaluated in other populations.

Understanding Complex Roles of Family for Latina Health: Evaluating Family Obligation Stress.

We developed a measure of family obligation stress and compared its relationship to health and unmet health care needs relative to social support among a sample of US-based Latinas. Data come from a randomized controlled trial within 4 clinics to increase mammography among Latinas (n = 539). The 1-factor measure had acceptable reliability and construct validity. Family obligation stress was associated with worse health and greater unmet health care needs. Family obligation stress varied by years in the United States and country of origin. Our measure of family obligation stress contributes new venues to family research among Latino populations.

Parent Observations of the Health Status of Infants With Clefts of the Lip: Results From Qualitative Interviews.

OBJECTIVE: To explore, using semistructured qualitative interviews, parent observations of their infant's health as they relate to having a cleft lip or cleft lip and cleft palate (CL±P) and/or associated treatments. DESIGN: Cross-sectional, qualitative study across 3 sites. SETTING: Parents were recruited from 3 academic craniofacial centers. Most interviews were conducted over the telephone, audio-recorded, and transcribed. PARTICIPANTS: Forty-one parents (31 English-, 10 Spanish-speaking) were interviewed. Parents had a child ages 1 to 35 months diagnosed with CL±P. MAIN OUTCOME MEASURE(S): Twelve domains reflecting infant health and well-being, likely affected by a CL±P and/or associated treatments, were identified from clinical experience and literature review. Study investigators conducted semistructured interviews based on 12 identified domains. After transcripts of the interviews were reviewed, our multidisciplinary team selected illustrative quotes from each domain that reflected consistent observations made by parents. RESULTS: Parents' responses covered all 12 domains. Specifically, parents discussed the domain of feeding most frequently, followed by observations about sleep, development, comfort, breathing, and vocalization. CONCLUSIONS: We found that parents of infants with clefts provided caregiver-centered language useful in describing their daily observations. No additional domains of infant health were noted by parents. We will use these observations and language to develop and validate a parent-reported observation diary that can augment assessments of the impacts of interventions on infants who are receiving care for CL±P.

In Vitro, In Silico, and In Vivo Analyses of Novel Aromatic Amidines against Trypanosoma cruzi.

Five bis-arylimidamides were assayed as anti-Trypanosoma cruzi agents by in vitro, in silico, and in vivo approaches. None were considered to be pan-assay interference compounds. They had a favorable pharmacokinetic landscape and were active against trypomastigotes and intracellular forms, and in combination with benznidazole, they gave no interaction. The most selective agent (28SMB032) tested in vivo led to a 40% reduction in parasitemia (0.1 mg/kg of body weight/5 days intraperitoneally) but without mortality protection. In silico target fishing suggested DNA as the main target, but ultrastructural data did not match.