The use of PROMIS patient-reported outcomes (PROs) to inform light chain (AL) amyloid disease severity at diagnosis.

We sought to evaluate how PROMIS patient-reported outcome (PRO) measures correlated with disease characteristics in systemic light chain (AL) amyloidosis patients at diagnosis. Newly diagnosed AL patients were recruited at two centres (N = 61). Patients completed the PROMIS Global Health v1.2, PROMIS-29 Profile v2.0 and Fatigue 8a v1.0. We assigned disease severity based on stage, presence of cardiac AL, and number of organs involved. We evaluated a) known groups validity by comparing PROMIS T-scores by disease severity, b) internal consistency using Cronbach's alpha and c) convergent/discriminant validity based on correlations across the domains and summary scores. Using receiver operating characteristic (ROC) curve analysis, NT-proBNP cut-off level corresponding to normal/mild vs moderate/severe PRO scores was determined. The median age was 68 (48-83) years with 58% males. Sixty-six percent had cardiac involvement and 25% had 3 or more organs involved with AL amyloidosis; 14% had stage 1, 28% stage 2, 36% stage 3 and 16% stage 4 disease. PROMIS measures had acceptable to excellent internal consistency and expected patterns of correlations. PROMIS Global Physical Health score was worse than the Global Mental Health Score at diagnosis; Physical function, fatigue and anxiety were the most impaired domains. PROMIS Global Health summary scores discriminated across AL amyloidosis stage and number of organs involved. Physical Function showed the strongest effects across known groups by stage, cardiac involvement and number of organs involved followed by Ability to Participate in Social Roles and Activities. A diagnostic NT-proBNP cut-off of 4200 pg/ml identified patients with moderate/severe PRO scores for these domains. Our results provide evidence for reliability and validity of select PROMIS short form measures in AL amyloidosis at diagnosis.

Psychometric evaluation and design of patient-centered communication measures for cancer care settings.

OBJECTIVE: To evaluate the psychometric properties of questions that assess patient perceptions of patient-provider communication and design measures of patient-centered communication (PCC). METHODS: Participants (adults with colon or rectal cancer living in North Carolina) completed a survey at 2 to 3 months post-diagnosis. The survey included 87 questions in six PCC Functions: Exchanging Information, Fostering Health Relationships, Making Decisions, Responding to Emotions, Enabling Patient Self-Management, and Managing Uncertainty. For each Function we conducted factor analyses, item response theory modeling, and tests for differential item functioning, and assessed reliability and construct validity. RESULTS: Participants included 501 respondents; 46% had a high school education or less. Reliability within each Function ranged from 0.90 to 0.96. The PCC-Ca-36 (36-question survey; reliability=0.94) and PCC-Ca-6 (6-question survey; reliability=0.92) measures differentiated between individuals with poor and good health (i.e., known-groups validity) and were highly correlated with the HINTS communication scale (i.e., convergent validity). CONCLUSION: This study provides theory-grounded PCC measures found to be reliable and valid in colorectal cancer patients in North Carolina. Future work should evaluate measure validity over time and in other cancer populations. PRACTICE IMPLICATIONS: The PCC-Ca-36 and PCC-Ca-6 measures may be used for surveillance, intervention research, and quality improvement initiatives.

Validation of the Vaccination Confidence Scale: A Brief Measure to Identify Parents at Risk for Refusing Adolescent Vaccines.

OBJECTIVE: To validate a brief measure of vaccination confidence using a large, nationally representative sample of parents. METHODS: We analyzed weighted data from 9018 parents who completed the 2010 National Immunization Survey-Teen, an annual, population-based telephone survey. Parents reported on the immunization history of a 13- to 17-year-old child in their households for vaccines including tetanus, diphtheria, and acellular pertussis (Tdap), meningococcal, and human papillomavirus vaccines. For each vaccine, separate logistic regression models assessed associations between parents' mean scores on the 8-item Vaccination Confidence Scale and vaccine refusal, vaccine delay, and vaccination status. We repeated analyses for the scale's 4-item short form. RESULTS: One quarter of parents (24%) reported refusal of any vaccine, with refusal of specific vaccines ranging from 21% for human papillomavirus to 2% for Tdap. Using the full 8-item scale, vaccination confidence was negatively associated with measures of vaccine refusal and positively associated with measures of vaccination status. For example, refusal of any vaccine was more common among parents whose scale scores were medium (odds ratio, 2.08; 95% confidence interval, 1.75-2.47) or low (odds ratio, 4.61; 95% confidence interval, 3.51-6.05) versus high. For the 4-item short form, scores were also consistently associated with vaccine refusal and vaccination status. Vaccination confidence was inconsistently associated with vaccine delay. CONCLUSIONS: The Vaccination Confidence Scale shows promise as a tool for identifying parents at risk for refusing adolescent vaccines. The scale's short form appears to offer comparable performance.

Development and validation of the Proxy-Reported Pulmonary Outcomes Scale for premature infants.

OBJECTIVE: Test the feasibility of using a bedside nurse-reported tool (Proxy-Reported Pulmonary Outcome Scale, PRPOS) for evaluating the severity of bronchopulmonary dysplasia (BPD) by assessing functional, disease-related measures. STUDY DESIGN: Bedside nurses tested the 26-item instrument by observing preterm infants (23-30 weeks at birth) at 36 to 37(4/7) weeks postmenstrual age before, during, and after a care time. We analyzed item reliability, validity, and model fit to determine the six items to include in the final measurement tool. RESULT: We completed assessments on 188 preterm infants. The frequency of an abnormal PRPOS item score increased with increasing National Institute of Child Health and Development (NICHD) BPD category. The six-candidate items produced an internally consistent scale. Addition of the NICHD BPD classification increased reliability moderately; addition of feeding items decreased reliability. The PRPOS score correlated with postmenstrual age at discharge. Infants discharged on oxygen or diuretics had higher median PRPOS scores than did infants who were not prescribed those therapies. CONCLUSION: The PRPOS is an internally consistent, proxy-reported measure of respiratory function in premature infants, based on observable, functional performance measures. Initial testing demonstrates known-groups validity and ongoing testing can assess predictive validity.

The Vaccination Confidence Scale: a brief measure of parents' vaccination beliefs.

PURPOSE: The success of national immunization programs depends on the public's confidence in vaccines. We sought to develop a scale for measuring confidence about adolescent vaccination in diverse populations of parents. METHODS: Data came from 9623 parents who completed the 2010 National Immunization Survey-Teen, an annual, population-based telephone survey. Parents reported on a 13- to 17-year-old child in their households. We used exploratory and confirmatory factor analysis to identify latent constructs underlying parents' responses to 8 vaccination belief survey items (response scale 0-10) conceptualized using the Health Belief Model. We assessed the scale's psychometric properties overall and across demographic subgroups. RESULTS: Parents' confidence about adolescent vaccination was generally high. Analyses provided support for three factors assessing benefits of vaccination (mean=8.5), harms of vaccination (mean=3.3), and trust in healthcare providers (mean=9.0). The model showed good fit both overall (comparative fit index=0.97) and across demographic subgroups, although internal consistency was variable for the three factors. We found lower confidence among several potentially vulnerable subpopulations, including mothers with lower levels of education and parents whose children were of Hispanic ethnicity (both p<0.05). CONCLUSIONS: Our brief, three-factor scale offers an efficient way to measure confidence in adolescent vaccination across demographic subgroups. Given evidence of lower confidence by educational attainment and race/ethnicity, program planners should consider factors such as health literacy and cultural competence when designing interventions to promote adolescent vaccination to ensure these programs are fully accessible.