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1.  Assessment of self-reported negative affect in the NIH Toolbox 
Psychiatry research  2012;206(1):88-97.
We report on the selection of self-report measures for inclusion in the NIH Toolbox that are suitable for assessing the full range of negative affect including sadness, fear, and anger. The Toolbox is intended to serve as a “core battery” of assessment tools for cognition, sensation, motor function, and emotional health that will help to overcome the lack of consistency in measures used across epidemiological, observational, and intervention studies. A secondary goal of the NIH Toolbox is the identification of measures that are flexible, efficient, and precise, an agenda best fulfilled by the use of item banks calibrated with models from item response theory (IRT) and suitable for adaptive testing. Results from a sample of 1,763 respondents supported use of the adult and pediatric item banks for emotional distress from the Patient-Reported Outcomes Measurement Information System (PROMIS®) as a starting point for capturing the full range of negative affect in healthy individuals. Content coverage for the adult Toolbox was also enhanced by the development of a scale for somatic arousal using items from the Mood and Anxiety Symptom Questionnaire (MASQ) and scales for hostility and physical aggression using items from the Buss-Perry Aggression Questionnaire (BPAQ).
doi:10.1016/j.psychres.2012.09.034
PMCID: PMC3561498  PMID: 23083918
sadness; fear; anger; item response theory; measurement
2.  The Comparability of English, French and Dutch Scores on the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F): An Assessment of Differential Item Functioning in Patients with Systemic Sclerosis 
PLoS ONE  2014;9(3):e91979.
Objective
The Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) is commonly used to assess fatigue in rheumatic diseases, and has shown to discriminate better across levels of the fatigue spectrum than other commonly used measures. The aim of this study was to assess the cross-language measurement equivalence of the English, French, and Dutch versions of the FACIT-F in systemic sclerosis (SSc) patients.
Methods
The FACIT-F was completed by 871 English-speaking Canadian, 238 French-speaking Canadian and 230 Dutch SSc patients. Confirmatory factor analysis was used to assess the factor structure in the three samples. The Multiple-Indicator Multiple-Cause (MIMIC) model was utilized to assess differential item functioning (DIF), comparing English versus French and versus Dutch patient responses separately.
Results
A unidimensional factor model showed good fit in all samples. Comparing French versus English patients, statistically significant, but small-magnitude DIF was found for 3 of 13 items. French patients had 0.04 of a standard deviation (SD) lower latent fatigue scores than English patients and there was an increase of only 0.03 SD after accounting for DIF. For the Dutch versus English comparison, 4 items showed small, but statistically significant, DIF. Dutch patients had 0.20 SD lower latent fatigue scores than English patients. After correcting for DIF, there was a reduction of 0.16 SD in this difference.
Conclusions
There was statistically significant DIF in several items, but the overall effect on fatigue scores was minimal. English, French and Dutch versions of the FACIT-F can be reasonably treated as having equivalent scoring metrics.
doi:10.1371/journal.pone.0091979
PMCID: PMC3956818  PMID: 24638101
3.  Emotion assessment using the NIH Toolbox 
Neurology  2013;80(11 Suppl 3):S76-S86.
One of the goals of the NIH Toolbox for Assessment of Neurological and Behavioral Function was to identify or develop brief measures of emotion for use in prospective epidemiologic and clinical research. Emotional health has significant links to physical health and exerts a powerful effect on perceptions of life quality. Based on an extensive literature review and expert input, the Emotion team identified 4 central subdomains: Negative Affect, Psychological Well-Being, Stress and Self-Efficacy, and Social Relationships. A subsequent psychometric review identified several existing self-report and proxy measures of these subdomains with measurement characteristics that met the NIH Toolbox criteria. In cases where adequate measures did not exist, robust item banks were developed to assess concepts of interest. A population-weighted sample was recruited by an online survey panel to provide initial item calibration and measure validation data. Participants aged 8 to 85 years completed self-report measures whereas parents/guardians responded for children aged 3 to 12 years. Data were analyzed using a combination of classic test theory and item response theory methods, yielding efficient measures of emotional health concepts. An overview of the development of the NIH Toolbox Emotion battery is presented along with preliminary results. Norming activities led to further refinement of the battery, thus enhancing the robustness of emotional health measurement for researchers using the NIH Toolbox.
doi:10.1212/WNL.0b013e3182872e11
PMCID: PMC3662334  PMID: 23479549
4.  Assessing Social Support, Companionship, and Distress: NIH Toolbox Adult Social Relationship Scales 
Objective
The quality of our daily social interactions – including perceptions of support, feelings of loneliness, and distress stemming from negative social exchanges – influence physical health and well-being. Despite the importance of social relationships, brief yet precise, unidimensional scales that assess key aspects of social relationship quality are lacking. As part of the NIH Toolbox for the Assessment of Neurological and Behavioral Function, we developed brief self-report scales designed to assess aspects of social support, companionship, and social distress across age cohorts. This report details the development and psychometric testing of the adult NIH Toolbox Social Relationship scales.
Methods
Social relationship concepts were selected, and item sets were developed and revised based on expert feedback and literature review. Items were then tested across a community-dwelling U.S. internet panel sample of adults aged 18 and above (N=692) using traditional (classic) psychometric methods and item response theory (IRT) approaches to identify items for inclusion in 5–8 item unidimensional scales. Finally, concurrent validity of the newly-developed scales was evaluated with respect to their inter-relationships with classic social relationship validation instruments.
Results
Results provide support for the internal reliability and concurrent validity of resulting self-report scales assessing Emotional Support, Instrumental Support, Friendship, Loneliness, Perceived Rejection, and Perceived Hostility.
Conclusion
These brief social relationship scales provide the pragmatic utility and enhanced precision needed to promote future epidemiological and social neuroscience research on the impact of social relationships on physical and emotional health outcomes.
doi:10.1037/a0028586
PMCID: PMC3759525  PMID: 23437856
social support; companionship; loneliness; social distress
5.  Comparison Of Methods To Estimate Health State Utilities For Ovarian Cancer Using Quality of Life Data: A Gynecologic Oncology Group Study 
Gynecologic oncology  2012;128(2):175-180.
Background
Cost-effectiveness/cost-utility analyses are increasingly needed to inform decisions about care. Algorithms have been developed using the Functional Assessment of Cancer Therapy (FACT) quality of life instrument to estimate utility weights for cost analyses. This study was designed to compare these algorithms in the setting of ovarian cancer.
Methods
GOG-0152 was a 550-patient randomized phase III trial of interval cytoreduction, and GOG-0172 was a 415-patient randomized phase III trial comparing intravenous versus intraperitoneal therapy among women with advanced ovarian cancer. QOL data were collected via the FACT at four time points in each study. Two published mapping algorithms (Cheung and Dobrez) and a linear transformation method were applied to these data. The agreement between measures was assessed by the concordance correlation coefficient (rCCC), and paired t-tests were used to compare means.
Results
While agreement between the estimation algorithms was good (ranged from 0.72 to 0.81), there were statistically significant (p<0.001) and clinically meaningful differences between the scores: mean scores were higher with Dobrez than with Cheung or the linear transformation method.. Scores were also statistically significantly different (p<0.001) between studies.
Conclusions
In the absence of prospectively collected utility data, the use of mapping algorithms is feasible, however, the optimal algorithm is not clear. There were significant differences between studies, which highlights the need for validation of these algorithms in specific settings. If cost analyses incorporate mapping algorithms to obtain utility estimates, investigators should take the variability into account.
doi:10.1016/j.ygyno.2012.10.024
PMCID: PMC3552113  PMID: 23123576
health utilities; ovarian cancer; quality of life; methodology; comparative effectiveness research
6.  General Population Norms for the Functional Assessment of Cancer Therapy – Kidney Symptom Index (FKSI) 
Cancer  2012;119(2):429-437.
Background
Metastatic renal cell cancer is associated with poor long-term survival and has no cure. Traditional clinical endpoints are best supplemented by patient-reported outcomes designed to assess symptoms and function. We obtained normative data on the NCCN - Functional Assessment of Cancer Therapy – Kidney Symptom Index (NFKSI) to aid in score interpretation and planning of future trials.
Methods
General population data were obtained from 2000 respondents, who completed the NFKSI-19, as well the SF-36 and the PROMIS-29, both general health status measures. Basic demographic and self-reported comorbidity data were also collected.
Results
The sample was 50% female, 85.7% Caucasian, with an equal distribution across age bands 18–75+. Most respondents (62.8%) had more than a high school education and reported an ECOG performance status of normal activity without symptoms (63.4%). Score distributions on the NFKSI-19, its subscales, and individual items are summarized.
Conclusions
The NFKSI-19 and its subscales now have scores for the general US population, allowing comparability to generic questionnaires such as the SF-36 and PROMIS-29. These data can be used to guide treatment expectations and plan future comparative effectiveness research using the scales.
doi:10.1002/cncr.27688
PMCID: PMC3470751  PMID: 22778010
quality of life; questionnaire; renal cell cancer; general population
7.  Neuro-QOL: quality of life item banks for adults with neurological disorders: item development and calibrations based upon clinical and general population testing 
Purpose
Neuro-QOL provides a clinically relevant and psychometrically robust health-related quality of life (HRQL) assessment tool for both adults and children with common neurological disorders. We now report the psychometric results for the adult tools.
Methods
An extensive research, survey and consensus process was used to produce a list of 5 priority adult neurological conditions (stroke, multiple sclerosis, Parkinson’s disease, epilepsy and ALS). We identified relevant health related quality of life (HRQL) domains through multiple methods and data sources including a comprehensive review of the literature and literature search, expert interviews and surveys and patient and caregiver focus groups. The final domain framework consisted of 17 domains of Physical, Mental and Social health. There were five phases of item development: (1) identification of 3,482 extant items, (2) item classification and selection, (3) item review and revision, (4) cognitive interviews with 63 patients to assess their understanding of individual items and (5) field testing of 432 representative items.
Participants and Procedures
Participants were drawn from the US general population and clinical settings, and included both English and Spanish speaking subjects (N = 3,246). Confirmatory factor analysis (CFA) was used to evaluate the dimensionality of unidimensional domains. Where the domain structure was previously unknown, the dataset was split and first analyzed with exploratory factor analysis and then CFA. Samejima’s graded response model (GRM) was used to calculate IRT parameters. We further evaluated differential item functioning (DIF) on gender, education and age.
Results
Thirteen unidimensional calibrated item banks consisting of 297 items were developed. All of the tested item banks had high reliability and few or no locally dependent items. The range of item slopes and thresholds with good information are reported for each of the item banks. The banks can support CAT and the development of short forms.
Conclusion
The Neuro-QOL measurement system provides item banks and short forms that enable PRO measurement in neurological research, minimizes patient burden and can be used to create multiple instrument types minimizing standard error. The 17 adult measures include 13 calibrated item banks, 3 item pools available for calibration work by others, and 1 stand-alone scale (index). The Neuro-QOL instruments provide a “common metric” of representative concepts for use across patient groups in different studies.
doi:10.1007/s11136-011-9958-8
PMCID: PMC3889669  PMID: 21874314
Outcome measures; Quality of life; Neurological disorders; Computerized adaptive testing, item banking
8.  Parent-perceived child cognitive function: results from a sample drawn from the US general population 
Purposes
This paper reports the development and evaluation of a perceived cognitive function (pedsPCF) item bank reported by parents of the pediatric US general population.
Methods
Based on feedback from clinicians, parents, and children, we developed a scale sampling concerns related to children’s cognitive functioning. We administered the scale to 1,409 parents of children aged 7–17 years; of them, 319 had a neurological diagnosis. Dimensionality of the pedsPCF was evaluated via factor analyses and its clinical utility studied by comparing parent ratings in patient groups and symptom cluster defined by the Child Behavior Checklist (CBCL).
Results
Forty-four of 45 items met criteria for unidimensionality. The pedsPCF significantly differentiated samples defined by medication use, repeated grades, special education status, neurologic diagnosis, and relevant symptom clusters with large effect sizes (>0.8). It can predicted children symptoms with the correction rates ranging 79–89%.
Conclusions
We have provided empirical support for the unidimensionality of the pedsPCF item bank and evidence for its potential clinical utility. The pedsPCF is a promising measurement tool to screen children for further comprehensive cognitive tests.
doi:10.1007/s00381-010-1230-y
PMCID: PMC3885608  PMID: 20652814
Perceived cognitive function; Children; Brain tumor; Neuro-oncology; Item bank
9.  Measurement of Fatigue in Cancer, Stroke, and HIV Using the Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F) Scale 
Objective
Given the importance of fatigue in cancer, stroke and HIV, we sought to assess the measurement properties of a single, well-described fatigue scale in these populations. We hypothesized that the psychometric properties of the Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F) subscale would be favorable and that the scale could serve as a useful indicator of fatigue in these populations.
Methods
Patients were eligible for the study if they were outpatients, aged 18 or older, with a diagnosis of cancer (n=297), stroke (n=51), or HIV/AIDS (n=51). All participants were able to understand and speak English. Patients answered study-related questions, including the FACIT-F using a touch-screen laptop, assisted by the research assistant as necessary. Clinical information was abstracted from patients’ medical records.
Results
Item-level statistics on the FACIT-F were similar across the groups and internal consistency reliability was uniformly high (α>0.91). Correlations with performance status ratings were statistically significant across the groups (range r=−0.28 to −0.80). Fatigue scores were moderately to highly correlated with general quality of life (range r=0.66–0.80) in patients with cancer, stroke, and HIV. Divergent validity was supported in low correlations with variables not expected to correlate with fatigue.
Conclusions
Originally developed to assess cancer-related fatigue, the FACIT-F has utility as a measure of fatigue in other populations, such as stroke and HIV. Ongoing research will soon allow for comparison of FACIT-F scores to those obtained using the fatigue measures from the Patient-Reported Outcomes Measurement Information System (PROMIS®; www.nihpromis.org) initiative.
doi:10.1016/j.jpsychores.2012.10.011
PMCID: PMC3534851  PMID: 23272990
fatigue; assessment; psychometrics; cancer; stroke; HIV
10.  A QUALITATIVE STUDY OF QUALITY OF LIFE AFTER STROKE: THE IMPORTANCE OF SOCIAL RELATIONSHIPS 
Background
Stroke is a leading cause of long-term disability in the USA; however, we have an incomplete understanding of how stroke affects long-term quality of life.
Methods
We report here findings from focus groups with 9 long-term stroke survivors and 6 caregivers addressing patients’ post-stroke quality of life.
Results
Key themes identified by patients were: social support, coping mechanisms, communication, physical functioning and independence. Role changes in patients were important to caregivers. Much of the discussion with patients and caregivers described specific ways in which the stroke altered social relationships.
Conclusion
These findings are consistent with prior research indicating the importance of social factors to quality of life following stroke. Our findings suggest that measures of stroke-related quality of life should include assessment of social function and social support.
doi:10.2340/16501977-0203
PMCID: PMC3869390  PMID: 18758667
stroke; quality of life; qualitative analysis; social function
11.  The case for an international patient-reported outcomes measurement information system (PROMIS®) initiative 
Patient-reported outcomes (PROs) play an increasingly important role in clinical practice and research. Modern psychometric methods such as item response theory (IRT) enable the creation of item banks that support fixed-length forms as well as computerized adaptive testing (CAT), often resulting in improved measurement precision and responsiveness. Here we describe and discuss the case for developing an international core set of PROs building from the US PROMIS® network.
PROMIS is a U.S.-based cooperative group of research sites and centers of excellence convened to develop and standardize PRO measures across studies and settings. If extended to a global collaboration, PROMIS has the potential to transform PRO measurement by creating a shared, unifying terminology and metric for reporting of common symptoms and functional life domains. Extending a common set of standardized PRO measures to the international community offers great potential for improving patient-centered research, clinical trials reporting, population monitoring, and health care worldwide. Benefits of such standardization include the possibility of: international syntheses (such as meta-analyses) of research findings; international population monitoring and policy development; health services administrators and planners access to relevant information on the populations they serve; better assessment and monitoring of patients by providers; and improved shared decision making.
The goal of the current PROMIS International initiative is to ensure that item banks are translated and culturally adapted for use in adults and children in as many countries as possible. The process includes 3 key steps: translation/cultural adaptation, calibration, and validation. A universal translation, an approach focusing on commonalities, rather than differences across versions developed in regions or countries speaking the same language, is proposed to ensure conceptual equivalence for all items. International item calibration using nationally representative samples of adults and children within countries is essential to demonstrate that all items possess expected strong measurement properties. Finally, it is important to demonstrate that the PROMIS measures are valid, reliable and responsive to change when used in an international context.
IRT item banking will allow for tailoring within countries and facilitate growth and evolution of PROs through contributions from the international measurement community. A number of opportunities and challenges of international development of PROs item banks are discussed.
doi:10.1186/1477-7525-11-210
PMCID: PMC3879205  PMID: 24359143
Patient-reported outcomes; Health-related quality of life research; Patients’ experiences; Questionnaires; Cross-cultural equivalence; Health information systems; Clinical decision making; Comparative effectiveness research; Patient empowerment; Cross-national comparisons
12.  Development and Validation of a Symptom Index for Advanced Hepatobiliary and Pancreatic Cancers: The NCCN-FACT Hepatobiliary-Pancreatic Symptom Index (NFHSI) 
Cancer  2012;118(23):5997-6004.
Objective
The 45-item Functional Assessment of Cancer Therapy – Hepatobiliary (FACT-Hep) questionnaire assesses health-related quality of life in patients with liver, bile duct and pancreatic cancers. Although the FACT-Hep was initially derived from patient input, we sought to verify adequate coverage of items by soliciting open-ended input from patients with advanced disease.
Methods
As part of a larger study in collaboration with the NCCN, 50 people (60% male, 80% Caucasian, average age 60.4 yrs) with Stage 3 or 4 hepatobiliary or pancreatic cancer were recruited. Participants generated and ranked up to 10 important symptoms and concerns that physicians should monitor when assessing the value of chemotherapy. Patients were also able to provide open-ended, qualitative information that was evaluated systematically. Ten expert physicians also provided input on priority symptoms.
Results
The resulting 18-item NCCN-FHSI (NFHSI-18) demonstrated high internal consistency (α = 0.89) and moderate to strong correlations with measures of physical well-being (ρ = 0.76), emotional well-being (ρ = 0.52), and functional well-being (ρ = 0.57). Scores on the NFHSI-18 were also highly correlated with the original hepatobiliary scale of the FACT-Hep (ρ = 0.82; all p<0.001). Compared to patients with better performance status, patients with poor performance status had worse NFHSI-18 symptom scores, F (3, 47) = 9.74; p=0.0003.
Conclusions
The NFHSI 18 assesses symptoms of importance to patients with hepatobiliary and pancreatic cancers and-demonstrates promising measurement properties. The scale is a good candidate for brief symptom assessment in clinical trials.
doi:10.1002/cncr.27588
PMCID: PMC3424375  PMID: 22605658
advanced cancer; symptom assessment; hepatobiliary cancer; pancreatic cancer
13.  NUTORC—a transdisciplinary health services and outcomes research team in transplantation 
The field of solid organ transplantation has historically concentrated research efforts on basic science and translational studies. However, there has been increasing interest in health services and outcomes research. The aim was to build an effective and sustainable, inter- and transdisciplinary health services and outcomes research team (NUTORC), that leveraged institutional strengths in social science, engineering, and management disciplines, coupled with an international recognized transplant program. In 2008, leading methodological experts across the university were identified and intramural funding was obtained for the NUTORC initiative. Inter- and transdisciplinary collaborative teams were created across departments and schools within the university. Within 3 years, NUTORC became fiscally sustainable, yielding more than tenfold return of the initial investment. Academic productivity included funding for 39 grants, publication of 60 manuscripts, and 166 national presentations. Sustainable educational opportunities for students were created. Inter- and transdisciplinary health services and outcomes research in transplant can be innovative and sustainable.
doi:10.1007/s13142-012-0176-x
PMCID: PMC3647618  PMID: 23667403
Transdisciplinary research teams; Health Services and Outcomes Research; Educational opportunities; Academic productivity; Sustainable research efforts
14.  Have a Little Faith: Measuring the Impact of Illness on Positive and Negative Aspects of Faith 
Psycho-oncology  2011;21(12):1357-1361.
OBJECTIVE
The importance of faith and its associations with health are well-documented. As part of the Patient Reported Outcomes Measurement Information System, items tapping positive and negative impact of illness (PII & NII) were developed across four content domains: Coping/Stress Response; Self-Concept; Social Connection/Isolation; Meaning and Spirituality. Faith items were included within the concept of meaning and spirituality.
METHODS
This measurement model was tested on a heterogeneous group of 509 cancer survivors. To evaluate dimensionality, we applied two bi-factor models, specifying a general factor (PII or NII) and four local factors: Coping/Stress Response, Self-Concept, Social Connection/Isolation, and Meaning and Spirituality.
RESULTS
Bi-factor analysis supported sufficient unidimensionality within PII and NII item sets. The unidimensionality of both PII and NII item sets was enhanced by extraction of the faith items from the rest of the questions. Of the 10 faith items, 9 demonstrated higher local than general factor loadings (range for local factor loadings= .402 to .876), suggesting utility as a separate but related “faith” factor. The same was true for only 2 of the remaining 63 items across the PII and NII item sets.
CONCLUSIONS
While conceptually and to a degree empirically related to Meaning and Spirituality, Faith appears to be a distinct subdomain of PII and NII, better-handled by distinct assessment. A 10-item measure of the impact of illness upon faith (II-Faith) was therefore assembled.
doi:10.1002/pon.2051
PMCID: PMC3705916  PMID: 21905161
cancer; oncology; measurement; psychosocial impact; faith
15.  Comparison of US Panel Vendors for Online Surveys 
Background
Despite the increasing use of panel surveys, little is known about the differences in data quality across panels.
Objective
The aim of this study was to characterize panel survey companies and their respondents based on (1) the timeliness of response by panelists, (2) the reliability of the demographic information they self-report, and (3) the generalizability of the characteristics of panelists to the US general population. A secondary objective was to highlight several issues to consider when selecting a panel vendor.
Methods
We recruited a sample of US adults from 7 panel vendors using identical quotas and online surveys. All vendors met prespecified inclusion criteria. Panels were compared on the basis of how long the respondents took to complete the survey from time of initial invitation. To validate respondent identity, this study examined the proportion of consented respondents who failed to meet the technical criteria, failed to complete the screener questions, and provided discordant responses. Finally, characteristics of the respondents were compared to US census data and to the characteristics of other panels.
Results
Across the 7 panel vendors, 2% to 9% of panelists responded within 2 days of invitation; however, approximately 20% of the respondents failed the screener, largely because of the discordance between self-reported birth date and the birth date in panel entry data. Although geographic characteristics largely agreed with US Census estimates, each sample underrepresented adults who did not graduate from high school and/or had annual incomes less than US $15,000. Except for 1 vendor, panel vendor samples overlapped one another by approximately 20% (ie, 1 in 5 respondents participated through 2 or more panel vendors).
Conclusions
The results of this head-to-head comparison provide potential benchmarks in panel quality. The issues to consider when selecting panel vendors include responsiveness, failure to maintain sociodemographic diversity and validated data, and potential overlap between panels.
doi:10.2196/jmir.2903
PMCID: PMC3869084  PMID: 24292159
survey methods; community surveys; sampling bias; selection bias; Internet; data sources
16.  L-Carnitine Supplementation for the Management of Fatigue in Patients With Cancer: An Eastern Cooperative Oncology Group Phase III, Randomized, Double-Blind, Placebo-Controlled Trial 
Journal of Clinical Oncology  2012;30(31):3864-3869.
Purpose
L-carnitine, a popular complementary and alternative medicine product, is used by patients with cancer for the treatment of fatigue, the most commonly reported symptom in this patient population. The purpose of this study was to determine the efficacy of L-carnitine supplementation as a treatment for fatigue in patients with cancer.
Patients and Methods
In this double-blind, placebo-controlled trial, patients with invasive malignancies and fatigue were randomly assigned to either 2 g/d of L-carnitine oral supplementation or matching placebo. The primary end point was the change in average daily fatigue from baseline to week 4 using the Brief Fatigue Inventory (BFI).
Results
Three hundred seventy-six patients were randomly assigned to treatment with L-carnitine supplementation or placebo. L-carnitine supplementation resulted in significant carnitine plasma level increase by week 4. The primary outcome, fatigue, measured using the BFI, improved in both arms compared with baseline (L-carnitine: −0.96, 95% CI, −1.32 to −0.60; placebo: −1.11, 95% CI −1.44 to −0.78). There were no statistically significant differences between arms (P = .57). Secondary outcomes, including fatigue measured by the Functional Assessment of Chronic Illness Therapy–Fatigue instrument, depression, and pain, did not show significant difference between arms. A separate analysis of patients who were carnitine-deficient at baseline did not show statistically significant improvement in fatigue or other outcomes after L-carnitine supplementation.
Conclusion
Four weeks of 2 g of L-carnitine supplementation did not improve fatigue in patients with invasive malignancies and good performance status.
doi:10.1200/JCO.2011.40.2180
PMCID: PMC3478577  PMID: 22987089
17.  Sexual Function of Endometrial Cancer Patients Enrolled on the Gynecologic Oncology Group LAP2 Study 
Objectives
To present responses to sexual function items contained within the quality of life (QOL) survey of the Gynecologic Oncology Group (GOG) LAP2 study, to investigate associations between sexual function and other factors such as relationship quality and body image), and to explore patterns of response in endometrial cancer patients.
Methods
Participants enrolled on the LAP2 QOL study arm completed a self-report QOL survey, which contained sexual function items, before surgery, and at 1, 3, 6-weeks and 6-months post surgery. Responses to sexual function questions were classified into three patterns—responder, intermittent responder and non-responder—based on whether the sexual function items were answered when the QOL survey was completed.
Results
Of 752 patients who completed the QOL survey, 225 completed the sexual function items within the QOL survey, 224 responded intermittently, and 303 did not respond at all. No significant differences of sexual function were found between the patients randomized to laparoscopy compared to laparotomy. Among those who responded completely or intermittently, sexual function scores declined after surgery and recovered to pre-surgery levels at 6 months. Sexual function was positively associated with better quality of relationship (P<0.001), body image (P<0.001), and QOL (P<0.001), and negatively associated with fear of sex (P<0.001).
Conclusion
Our findings suggest that younger patients, those who were married, and those who had quality relationships were more likely to answer the sexual function items and have better quality of sexual function. Factors such as age, relationship quality, body image, and pain may place women with endometrial cancer at risk for sexual difficulties in the immediate recovery period; however, sexual function improved by 6-months postoperatively in our cohort of early-stage endometrial cancer patients.
doi:10.1097/IGC.0b013e31827277fa
PMCID: PMC3536465  PMID: 23095778
sexual function; endometrial cancer; gynecologic cancer treatment; laparoscopy; laparotomy
18.  The psychosocial impact of cancer: evidence in support of independent general positive and negative components 
Purpose
Considerable research has demonstrated the negative psychosocial impact of cancer. Recent work has highlighted positive psychosocial outcomes. Research is now needed to evaluate the relationship between negative and positive impacts. This paper reports the development and validation of a measurement model capturing positive and negative psychosocial illness impacts.
Methods
The sample included 754 cancer patients on- or post-treatment. Item development was informed by literature review, expert input patient interviews and the results of a pilot study of 205 cancer patients, resulting in 43 positive and 46 negative items. Factor analyses were used to evaluate the dimensionality of the item pools. Analysis of variance (ANOVA) was used to examine relationships between psychosocial illness impact and other variables.
Results
Unidimensionality was demonstrated within but not across negative and positive impact items. ANOVA results showed differential relationships between negative and positive impacts, respectively, and patient sociodemographic and clinical variables.
Conclusion
Positive and negative psychosocial illness impacts are best conceptualized and measured as two independent factors. Computerized adaptive tests and short-form measures developed from this comprehensive psychosocial illness impact item bank may benefit future research and clinical applications.
doi:10.1007/s11136-011-9935-2
PMCID: PMC3766316  PMID: 21643875
Psychosocial sequelae; Cancer; Cancer survivors; Bi-factor analysis
19.  Health-Related Quality of Life Differences between African-Americans and Non-Hispanic Whites with Head and Neck Cancer 
Head & neck  2012;35(9):1255-1264.
Background
Cancers of the head and neck are associated with detriments in health-related quality of life (HRQOL), however little is known about different experiences between African Americans and non-Hispanic whites.
Methods
HRQOL was measured by the Functional Assessment of Cancer Therapy – Head and Neck approximately five months post diagnosis among 222 cancer patients from North Carolina. Higher scores represent better HRQOL. Regression models included sociodemographic characteristics and clinical factors.
Results
African Americans reported higher Physical Well-Being than Caucasians (adjusted means 23.1 vs 20.9). African Americans with incomes <$20,000 reported higher Emotional Well-Being (21.4) and fewer head and neck symptoms (22.0). Non-Hispanic whites making <$20,000 reported the poorest Emotional Well-Being (17.3) while African Americans making >$20,000 reported the most head and neck symptoms (18.7).
Conclusions
Further investigation is needed to explore variation in HRQOL experiences among different race and socio-economic groups that may inform resource allocation to improve cancer care.
doi:10.1002/hed.23115
PMCID: PMC3750061  PMID: 22907719
health-related quality of life; head and neck cancer; African Americans
20.  Quality of life, Risk Assessment, and Safety Research in Liver Transplantation: New Frontiers in Health Services and Outcomes Research 
Purpose of review
In this review, we briefly summarize three fruitful, emerging areas in liver transplantation research: quality of life; risk assessment; and patient safety. Our goal is to highlight recent findings in these areas, with a call for increased integration of social scientists and transplant clinicians to address how best to shape policy and improve outcomes.
Recent findings
After liver transplantation, recipients generally experience clinically significant, sustained improvement in their physical, social and emotional well-being. However, a sizeable minority of patients do experience excess morbidity that may benefit from ongoing surveillance and/or intervention. There is growing body of research that describes risks associated with liver transplantation, which can be useful aids to better inform decision making by patients, clinicians, payers, and policy makers. In contrast, there has been a relative lack of empirical data on transplant patient safety vulnerabilities, placing the field of surgery in stark contrast to other high risk industries, where such assessments inform continuous process improvement.
Summary
Health services and outcomes research has grown in importance in the liver transplantation literature, but several important questions remain unanswered that merit programmatic, interdisciplinary research.
doi:10.1097/MOT.0b013e32835365c6
PMCID: PMC3740962  PMID: 22476225
liver transplantation; recipients; quality of life; risk assessment; patient safety; outcomes
21.  A Comparison of Quality-of-Life Domains and Clinical Factors in Ovarian Cancer Patients: A Gynecologic Oncology Group Study 
Context
Women diagnosed with ovarian cancer are at risk for reduced quality of life (QOL). It is imperative to further define these declines to interpret treatment outcomes and design appropriate clinical interventions.
Objectives
The primary objective of this study was to compare data obtained from ovarian cancer patients with normative data to assess the degree to which QOL differs from the norm. Secondary objectives were to examine demographic variables and determine if there was a correlation between physical/functional and social/emotional scores during chemotherapy.
Methods
Patients with Stage III/IV ovarian cancer on Gynecologic Oncology Group Protocols 152 and 172 who underwent surgery followed by intravenous paclitaxel and cisplatin completed the Functional Assessment of Cancer Therapy-Ovarian. The Functional Assessment of Cancer Therapy scale includes the four domains of physical, functional, social, and emotional well-being (PWB, FWB, SWB, and EWB, respectively).
Results
Ovarian cancer patients had a total QOL (Functional Assessment of Cancer Therapy-General) score similar to the U.S. female adult population. However, the reported subscale scores were 2.0 points (95% confidence interval [CI] 1.4–2.5, P < 0.001, effect size = 0.37) lower in PWB, 0.9 points (95% CI 0.3–1.5, P = 0.005, effect size = 0.13) lower in FWB, 5.0 points (95% CI 4.6–5.3, P < 0.001, effect size = 0.74) higher in SWB, and 0.8 points (95% CI 0.3–1.2, P < 0.001, effect size = 0.16) lower in EWB. Correlation between the sum of PWB and FWB and the sum of SWB and EWB was r = 0.53 (P < 0.001). Age was positively correlated with EWB (r = 0.193; 95% CI 0.09–0.29).
Conclusion
Ovarian cancer patients have decreased QOL in physical, functional, and emotional domains; however, they may compensate with increased social support. At the time of diagnosis and treatment, patients’ QOL is affected by inherent characteristics. Assessment of treatment outcomes should take into account the effect of these independent variables.
doi:10.1016/j.jpainsymman.2009.09.022
PMCID: PMC3715039  PMID: 20471545
Ovarian cancer; chemotherapy; quality of life
22.  Quality-of-Life Measures in Children With Neurological Conditions: Pediatric Neuro-QOL 
Background
A comprehensive, reliable, and valid measurement system is needed to monitor changes in children with neurological conditions who experience lifelong functional limitations.
Objective
This article describes the development and psychometric properties of the pediatric version of the Quality of Life in Neurological Disorders (Neuro-QOL) measurement system.
Methods
The pediatric Neuro-QOL consists of generic and targeted measures. Literature review, focus groups, individual interviews, cognitive interviews of children and consensus meetings were used to identify and finalize relevant domains and item content. Testing was conducted on 1018 children aged 10 to 17 years drawn from the US general population for generic measures and 171 similarly aged children with muscular dystrophy or epilepsy for targeted measures. Dimensionality was evaluated using factor analytic methods. For unidimensional domains, item parameters were estimated using item response theory models. Measures with acceptable fit indices were calibrated as item banks; those without acceptable fit indices were treated as summary scales.
Results
Ten measures were developed: 8 generic or targeted banks (anxiety, depression, anger, interaction with peers, fatigue, pain, applied cognition, and stigma) and 2 generic scales (upper and lower extremity function). The banks reliably (r > 0.90) measured 63.2% to 100% of the children tested.
Conclusions
The pediatric Neuro-QOL is a comprehensive measurement system with acceptable psychometric properties that could be used in computerized adaptive testing. The next step is to validate these measures in various clinical populations.
doi:10.1177/1545968311412054
PMCID: PMC3710728  PMID: 21788436
health-related quality of life; children; neurological disorders; item bank; item response theory
23.  Application of the National Institutes of Health Patient-Reported Outcomes Measurement Information System (PROMIS®) to Mental Health Research 
Background
The Patient-Reported Outcomes Measurement Information System (PROMIS) is a National Institutes of Health initiative to develop item banks measuring patient-reported outcomes (PROs) and to create and make available a computerized adaptive testing system (CAT) that allows for efficient and precise assessment of PROs in clinical research and practice.
Aims of the Study
Based on the presentation from a symposium on “Evidence-based Outcomes in Psychiatry: Updates on Measurement Using Patient-Reported Outcomes (PRO)” at the 2011 American Psychiatry Association Convention, this paper provides an overview of PROMIS and its application to mental health research.
Methods
The PROMIS methodology for item bank development and testing is described, with a focus on the implications of this work for mental health research.
Results
Utilizing qualitative item review and state-of-the-art applications of item response theory (IRT), PROMIS investigators have developed, tested, and released item banks measuring physical, mental, and social health components. Ongoing efforts continue to add new item banks and further validate existing banks.
Discussion
PROMIS provides item banks measuring several domains of interest to mental health researchers including emotional distress, social function, and sleep. PROMIS methodology also provides a rigorous standard for the development of new mental health measures.
Implications for Health Care Provision
Web-based CAT or administration of short forms derived from PROMIS item banks provide efficient and precise dimensional estimates of clinical outcomes that can be utilized to monitor patient progress and assess quality improvement.
Implications for Future Research
Use of the dimensional PROMIS metrics (and co-calibration of the PROMIS item banks with existing PROs) will allow comparisons of mental health and related health outcomes across disorders and studies.
PMCID: PMC3705221  PMID: 22345362
24.  How Item Banks and Their Application Can Influence Measurement Practice in Rehabilitation Medicine: A PROMIS Fatigue Item Bank Example 
Objective
To illustrate how measurement practices can be advanced using as an example the fatigue item bank (FIB) and its applications (short-forms and computerized adaptive test) that were developed via the NIH Patient Reported Outcomes Measurement Information System (PROMIS) Cooperative Group.
Design
Psychometric analysis of data collected by an internet survey company using Item Response Theory (IRT) related techniques.
Setting
A United States general population representative sample collected via internet.
Participants
803 respondents used for dimensionality evaluation of the PROMIS FIB and 14,931 respondents used for item calibrations
Interventions
Not applicable.
Main Outcome Measures
112 fatigue items developed by the PROMIS fatigue domain working group, 13-item Functional Assessment of Chronic Illness Therapy-Fatigue, and 4-item SF-36 Vitality scale.
Results
The PROMIS FIB version 1 which consists of 95 items demonstrated acceptable psychometric properties. Computerized Adaptive Testing (CAT) showed consistently better precision than short-forms. However, all three short-forms showed good precision for the majority of participants, in that more than 95% of sample could be precisely measured with a reliability greater than 0.9.
Conclusions
Measurement practice can be advanced by using a psychometrically sound measurement tool and its applications. This example shows that CAT and short-forms derived from the PROMIS FIB can reliably estimate fatigue reported by the US general population. Evaluation in clinical populations is warranted before the item bank can be used for clinical trials.
doi:10.1016/j.apmr.2010.08.033
PMCID: PMC3696589  PMID: 21958919
PROMIS; fatigue; CAT; short-form
25.  The Use of PROMIS and Assessment Center to Deliver Patient-Reported Outcome Measures in Clinical Research 
Journal of applied measurement  2010;11(3):304-314.
The Patient-Reported Outcomes Measurement Information System (PROMIS) was developed as one of the first projects funded by the NIH Roadmap for Medical Research Initiative to re-engineer the clinical research enterprise. The primary goal of PROMIS is to build item banks and short forms that measure key health outcome domains that are manifested in a variety of chronic diseases which could be used as a “common currency” across research projects. To date, item banks, short forms and computerized adaptive tests (CAT) have been developed for 13 domains with relevance to pediatric and adult subjects. To enable easy delivery of these new instruments, PROMIS built a web-based resource (Assessment Center) for administering CATs and other self-report data, tracking item and instrument development, monitoring accrual, managing data, and storing statistical analysis results. Assessment Center can also be used to deliver custom researcher developed content, and has numerous features that support both simple and complicated accrual designs (branching, multiple arms, multiple time points, etc.). This paper provides an overview of the development of the PROMIS item banks and details Assessment Center functionality.
PMCID: PMC3686485  PMID: 20847477

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