Background

Antibiotics are frequently prescribed to children, and may be an environmental influence that contributes to the increasing prevalence of childhood obesity. The aim of this study was to examine the effect of antibiotic use in the first year of life on child growth trajectories from birth to age 6 years including significant covariates.

Methods

Data from 586 children in the Infant Feeding Practices II (IFPS II) and 6 year follow-up study (6YFU) were included. Antibiotic exposures, weight and height measurements were collected from birth through the first 12 months, and then again at 6 years. Linear mixed effects growth modeling, controlling for exclusive breastfeeding, socio-demographic factors, smoking during pregnancy, gestational diabetes, and maternal pre-pregnancy weight status, was used to examine the association between antibiotic exposure and child growth trajectories through age 6 years.

Results

The majority of infants (60.58%) did not receive any antibiotics; 33.79% received 1-2 courses and 5.63% received 3 or more antibiotic courses during the first year. In the unadjusted model, children with 1-2 antibiotic exposures had a 0.17 (SE 0.08) higher rate of change in BMI z-score (BMIz) than children without any antibiotics, and children with ≥3 exposures had a 0.42 (SE 0.16) higher rate of change in BMIz (p = 0.009). Growth trajectory over time for those who had ≥3 antibiotics was greater than those without any antibiotics (p = 0.002).

Conclusions

Efforts to guide the judicious use of antibiotics should continue, particularly in the first year of life.

PURPOSE: To evaluate the validity of the Patient-Reported Outcomes Measurement Information System (PROMIS) physical function measures in a diverse, population-based cancer sample. METHODS: Cancer patients 6-13 months post-diagnosis (n = 4840) were recruited for the Measuring Your Health study. Participants were diagnosed between 2010 and 2013 with non-Hodgkin lymphoma or cancers of the colorectum, lung, breast, uterus, cervix, or prostate. Four PROMIS physical function short forms (4a, 6b, 10a, and 16) were evaluated for validity and reliability across age and race-ethnicity groups. Covariates included gender, marital status, education level, cancer site and stage, comorbidities, and functional status. RESULTS: PROMIS physical function short forms showed high internal consistency (Cronbachs α = 0.92-0.96), convergent validity (fatigue, pain interference, FACT physical well-being all r ≥ 0.68), and discriminant validity (unrelated domains all r ≤ 0.3) across survey short forms, age, and race-ethnicity. Known-group differences by demographic, clinical, and functional characteristics performed as hypothesized. Ceiling effects for higher-functioning individuals were identified on most forms. CONCLUSIONS: This study provides strong evidence that PROMIS physical function measures are valid and reliable in multiple race-ethnicity and age groups. Researchers selecting specific PROMIS short forms should consider the degree of functional disability in their patient population to ensure that length and content are tailored to limit response burden.

Purpose

To evaluate the reliability and construct validity of measures from the Patient-Reported Outcomes Measurement Information System(®) (PROMIS(®)) for patients with heart failure before and after heart transplantation.

Methods

We assessed reliability of the PROMIS short forms using Cronbach's alpha and the average marginal reliability. To assess the construct validity of PROMIS computerized adaptive tests and short-form measures, we calculated Pearson product moment correlations between PROMIS measures of physical function, fatigue, depression, and social function and existing PRO measures of similar domains (i.e., convergent validity) as well as different domains (i.e., discriminate validity) in patients with heart failure awaiting heart transplant. We evaluated the responsiveness of these measures to change after heart transplant using effect sizes.

Results

Forty-eight patients were included in the analyses. Across the many domains examined, correlations between conceptually similar domains were larger than correlations between different domains of health, demonstrating construct validity. Health status improved substantially after heart transplant (standardized effect sizes, 0.63-1.24), demonstrating the responsiveness of the PROMIS measures. Scores from the computerized adaptive tests and the short forms were similar.

Conclusions

This study provides evidence for the reliability and construct validity (including responsiveness to change) of four PROMIS domains in patients with heart failure before and after heart transplant. PROMIS measures are a reasonable choice in this context and will facilitate comparisons across studies and health conditions.

Background

The Patient-Reported Outcomes Measurement Information System (PROMIS) was a National Institutes of Health-funded initiative to develop measures of symptoms and function. Responsiveness is the degree to which a measure can detect underlying changes over time. The objective of the current study was to document the responsiveness of 8 PROMIS measures in a large, population-based cancer cohort.

Methods

The Measuring Your Health study recruited 2968 patients who were diagnosed with 1 of 7 cancers between 2010 and 2012 through 4 Surveillance, Epidemiology, and End Results registries. Participants completed a baseline survey (6-13 months after diagnosis) and a 6-month follow-up survey. Changes in 8 PROMIS scores were compared with global ratings of transition, changes in performance status, and clinical events.

Results

Measures were responsive to 6-month declines and improvements in performance status with small to large effect sizes (ES) (Cohen d = 0.34-0.71; P < .01). Mean changes and effect sizes were larger for participants who reported declines compared with those who reported improvements. Small-to-medium ES were observed in patients who reported being "a little" worse (d = 0.31-0.56), and medium-to-large ES were observed in those who reported being "a lot" worse (d = 0.53-0.72). Hospitalized participants reported significant score increases, resulting in worsening of pain (d = 0.51), fatigue (d = 0.35), and depression (d = 0.57; all P < .01). Cancer recurrence and progression were associated with smaller increases in pain, fatigue, and sleep disturbance (d = 0.22-0.27).

Conclusions

The current results indicated that all 8 PROMIS measures were sensitive to patient-perceived worsening and improvement and to major clinical events. These findings will be able to inform the design and interpretation of future research studies and clinical initiatives administering PROMIS measures. Cancer 2017;123:327-335. © 2016 American Cancer Society.

Objective

The diagnostic boundaries of sleep disorders are under considerable debate. The main sleep disorders are partly heritable; therefore, defining heritable pathophysiologic mechanisms could delineate diagnoses and suggest treatment. We collected clinical data and DNA from consenting patients scheduled to undergo clinical polysomnograms, to expand our understanding of the polymorphisms associated with the phenotypes of particular sleep disorders.

Methods

Patients at least 21 years of age were recruited to contribute research questionnaires, and to provide access to their medical records, saliva for deoxyribonucleic acid (DNA), and polysomnographic data. From these complex data, 38 partly overlapping phenotypes were derived indicating complaints, subjective and objective sleep timing, and polysomnographic disturbances. A custom chip was used to genotype 768 single-nucleotide polymorphisms (SNPs). Additional assays derived ancestry-informative markers (eg, 751 participants of European ancestry). Linear regressions controlling for age, gender, and ancestry were used to assess the associations of each phenotype with each of the SNPs, highlighting those with Bonferroni-corrected significance.

Results

In peroxisome proliferator-activated receptor gamma, coactivator 1 beta (PPARGC1B), rs6888451 was associated with several markers of obstructive sleep apnea. In aryl hydrocarbon receptor nuclear translocator-like (ARNTL), rs10766071 was associated with decreased polysomnographic sleep duration. The association of rs3923809 in BTBD9 with periodic limb movements in sleep was confirmed. SNPs in casein kinase 1 delta (CSNK1D rs11552085), cryptochrome 1 (CRY1 rs4964515), and retinoic acid receptor-related orphan receptor A (RORA rs11071547) were less persuasively associated with sleep latency and time of falling asleep.

Conclusions

SNPs associated with several sleep phenotypes were suggested, but due to risks of false discovery, independent replications are needed before the importance of these associations can be assessed, followed by investigation of molecular mechanisms.

Purpose

To evaluate the validity of the Patient-Reported Outcomes Measurement Information System (PROMIS) physical function measures in a diverse, population-based cancer sample.

Methods

Cancer patients 6-13 months post-diagnosis (n = 4840) were recruited for the Measuring Your Health study. Participants were diagnosed between 2010 and 2013 with non-Hodgkin lymphoma or cancers of the colorectum, lung, breast, uterus, cervix, or prostate. Four PROMIS physical function short forms (4a, 6b, 10a, and 16) were evaluated for validity and reliability across age and race-ethnicity groups. Covariates included gender, marital status, education level, cancer site and stage, comorbidities, and functional status.

Results

PROMIS physical function short forms showed high internal consistency (Cronbach's α = 0.92-0.96), convergent validity (fatigue, pain interference, FACT physical well-being all r ≥ 0.68), and discriminant validity (unrelated domains all r ≤ 0.3) across survey short forms, age, and race-ethnicity. Known-group differences by demographic, clinical, and functional characteristics performed as hypothesized. Ceiling effects for higher-functioning individuals were identified on most forms.

Conclusions

This study provides strong evidence that PROMIS physical function measures are valid and reliable in multiple race-ethnicity and age groups. Researchers selecting specific PROMIS short forms should consider the degree of functional disability in their patient population to ensure that length and content are tailored to limit response burden.

Abstract Background There are several indications that malfunctions of the circadian clock contribute to depression. To search for particular circadian gene polymorphisms associated with depression, diverse polymorphisms were genotyped in two samples covering a range of depressed volunteers and participants with normal mood. Methods Depression mood self-ratings and DNA were collected independently from a sample of patients presenting to a sleep disorders center (1086 of European origin) and from a separate sample consisting of 399 participants claiming delayed sleep phase symptoms and 406 partly-matched controls. A custom Illumina Golden Gate array of 768 selected single nucleotide polymorphisms (SNPs) was assayed in both samples, supplemented by additional SNPlex and Taqman assays, including assay of 41 ancestry-associated markers (AIMs) to control stratification. Results In the Sleep Clinic sample, these assays yielded Bonferroni-significant association with depressed mood in three linked SNPs of the gene FMR1: rs25702 (nominal P=1.77E-05), rs25714 (P=1.83E-05), and rs28900 (P=5.24E-05). This FMR1 association was supported by 8 SNPs with nominal significance and a nominally-significant gene-wise set test. There was no association of depressed mood with FMR1 in the delayed sleep phase case–control sample or in downloaded GWAS data from the GenRED 2 sample contrasting an early-onset recurrent depression sample with controls. No replication was located in other GWAS studies of depression. Our data did weakly replicate a previously-reported association of depression with PPARGC1B rs7732671 (P=0.0235). Suggestive associations not meeting strict criteria for multiple testing and replication were found with GSK3B, NPAS2, RORA, PER3, CRY1, MTNR1A and NR1D1. Notably, 16 SNPs nominally associated with depressed mood (14 in GSK3B) were also nominally associated with delayed sleep phase syndrome (P=3E10-6). Conclusions Considering the inconsistencies between samples and the likelihood that the significant three FMR1 SNPs might be linked to complex polymorphisms more functionally related to depression, large gene resequencing studies may be needed to clarify the import for depression of these circadian genes.

Purpose

To evaluate how well three different patient-reported outcomes (PROs) measure individual change.

Methods

Two hundred and fourteen patients (from two sites) initiating first or new chemotherapy for any stage of breast or gastrointestinal cancer participated. The 13-item FACIT Fatigue scale, a 7-item PROMIS^® Fatigue Short Form (PROMIS 7a), and the PROMIS^® Fatigue computer adaptive test (CAT) were administered monthly online for 6 months. Reliability of measured change was defined, under a population mixed effects model, as the ratio of estimated systematic variance in rate of change to the estimated total variance of measured individual differences in rate of change. Precision of individual measured change, the standard error of measurement of change, was given by the square root of the rate-of-change sampling variance. Linear and quadratic models were examined up to 3 and up to 6 months.

Results

A linear model for measured change showed the following by 6 and 3 months, respectively: PROMIS CAT (0.363 and 0.342); PROMIS SF (0.408 and 0.533); FACIT (0.459 and 0.473). Quadratic models offered no noteworthy improvement over linear models. Both reliability and precision results demonstrate the need to improve the measurement of intra-individual change.

Conclusions

These results illustrate the challenge of reliably measuring individual change in fatigue with a level of confidence required for intervention. Optimizing clinically useful measurement of intra-individual differences over time continues to pose a challenge for PROs.

Background

A better understanding is needed of the burdens and benefits of left ventricular assist device (LVAD) implantation on patients' physical, mental, and social well-being. The purpose of this report was to evaluate the validity of Patient-Reported Outcomes Measurement Information System (PROMIS) measures for LVAD patients and to estimate clinically important score differences likely to have implications for patient treatment or care.

Methods

Adults from 12 sites across all US geographic regions completed PROMIS measures ≥3 months post-LVAD implantation. Other patient-reported outcomes (eg, Kansas City Cardiomyopathy Questionnaire-12 item), clinician ratings, performance tests, and clinical adverse events were used as validity indicators. Criterion and construct validity and clinically important differences were estimated with Pearson correlations, ANOVA methods, and Cohen d effect sizes.

Results

Participants' (n=648) mean age was 58 years, and the majority were men (78%), non-Hispanic White people (68%), with dilated cardiomyopathy (55%), long-term implantation strategy (57%), and New York Heart Association classes I and II (54%). Most correlations between validity indicators and PROMIS measures were medium to large (≥0.3; p<0.01). Most validity analyses demonstrated medium-to-large effect sizes (≥0.5) and clinically important differences in mean PROMIS scores (up to 14.8 points). Ranges of minimally important differences for 4 PROMIS measures were as follows: fatigue (3-5 points), physical function (2-3), ability to participate in social roles and activities (3), and satisfaction with social roles and activities (3-5).

Conclusions

The findings provide convincing evidence for the relevance and validity of PROMIS physical, mental, and social health measures in patients from early-to-late post-LVAD implantation. Findings may inform shared decision-making when patients consider treatment options. Patients with an LVAD, their caregivers, and their clinicians should find it useful to interpret the meaning of their PROMIS scores in relation to the general population, that is, PROMIS may help to monitor a return to normalcy in everyday life.

Study participants (n = 272) completed 12 Patient-Reported Outcomes Measurement Information System (PROMIS) physical, mental and social health measures (questionnaires) prior to implantation of a left ventricular assist device (LVAD) and again at 3 and 6 months postimplant. All but 1 PROMIS measure demonstrated significant improvement from pre-implant to 3 months; there was little change between 3 and 6 months. Because PROMIS measures were developed in the general population, patients with an LVAD, their caregivers and their clinicians can interpret the meaning of PROMIS scores in relation to the general population, helping them to monitor a return to normalcy in everyday life.