San Keller

Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain.

Objectives:The Brief Pain Inventory (BPI) is a short, self-administered questionnaire that was developed for use in cancer patients. While most empirical research with the BPI has been in pain of that etiology, the questionnaire is increasingly evident in published studies of patients with non-cancer pain. The current research addresses the need for formal evaluation of the reliability and validity of the BPI for use in non-cancer pain patients. Methods:Approximately 250 patients with arthritis or low back pain (LBP) self-administered a number of generic and condition-specific health status measures (including the BPI) in the clinic of their primary care provider at 2 time points: the initial clinic visit and the first visit following treatment. Results:The reliability of BPI data collected from non-cancer pain patients was comparable to that reported in the literature for cancer patients and sufficient for group-level analyses (coefficient alphas were greater than 0.70). The factor structure of the BPI was replicated in this sample and the relationship of the BPI to generic measures of pain was strong. The BPI exhibited similar relationships to general and condition-specific measures of health as did a generic pain scale (SF-36 Bodily Pain). Finally, the BPI discriminated among levels of condition severity and was sensitive to change in condition over time in arthritis and LBP patients. Discussion:Results support the validity of the BPI as a measure of pain in patients without cancer and, in particular, as a measure of pain for arthritis and LBP patients.

Patient reports of health outcome for adults living with sickle cell disease: development and testing of the ASCQ-Me item banks.

BackgroundProviders and patients have called for improved understanding of the health care requirements of adults with sickle cell disease (SCD) and have identified the need for a systematic, reliable and valid method to document the patient-reported outcomes (PRO) of adult SCD care. To address this need, the Adult Sickle Cell Quality of Life Measurement System (ASCQ-Me) was designed to complement the Patient Reported Outcome Measurement Information System (PROMIS®). Here we describe methods and results of the psychometric evaluation of ASCQ-Me item banks (IBs).MethodsAt seven geographically-disbursed clinics within the US, 556 patients responded to questions generated to assess cognitive, emotional, physical and social impacts of SCD. We evaluated the construct validity of the hypothesized domains using exploratory factor analysis (EFA), parallel analysis (PA), and bi-factor analysis (Item Response Theory Graded Response Model, IRT-GRM). We used IRT-GRM and the Wald method to identify bias in responses across gender and age. We used IRT and Cronbach’s alpha coefficient to evaluate the reliability of the IBs and then tested the ability of summary scores based on IRT calibrations to discriminate among tertiles of respondents defined by SCD severity.ResultsOf the original 140 questions tested, we eliminated 48 that either did not form clean factors or provided biased measurement across subgroups defined by age and gender. Via EFA and PA, we identified three subfactors within physical impact: sleep, pain and stiffness impacts. Analysis of the resulting six item sets (sleep, pain, stiffness, cognitive, emotional and social impacts of SCD) supported their essential unidimensionality. With the exception of the cognitive impact IB, these item sets also were highly reliable across a broad range of values and highly significantly related to SCD disease severity.ConclusionASCQ-Me pain, sleep, stiffness, emotional and social SCD impact IBs demonstrated exceptional measurement properties using modern and classical psychometric methods of evaluation. Further development of the cognitive impact IB is required to improve its sensitivity to differences in SCD disease severity. Future research will evaluate the sensitivity of the ASCQ-Me IBs to change in SCD disease severity over time due to health interventions.

Giving voice to the vulnerable: the development of a CAHPS nursing home survey measuring family members' experiences.

Background:To complement a nursing home resident survey, the team developed a survey asking family members about their experiences with nursing homes. Although a family member does not receive care directly from a nursing home, their experiences at the nursing home and with staff can contribute to understanding nursing home quality. Objectives:To describe how the nursing home family member instrument was developed, refined, tested, and finalized. Research Design:The team developed a draft survey using information from a literature review, 12 focus groups with family members involved in choosing a nursing home for someone, review of nursing home surveys, and expert/stakeholder input. The survey went through 2 rounds of cognitive interviews (n=54) and revisions and was fielded in 15 nursing homes. Data from the pilot survey (n=885) were subjected to psychometric analyses to evaluate the measurement properties of items as well as the reliability and validity of the resulting composites. On the basis of these analyses and input from experts, the survey was finalized. Results:Focus groups and experts provided input into discerning important indicators of quality, although in some cases family members were not the best sources of information. Cognitive testing refined the survey and eliminated some of the proxy items. The field test analysis and input from experts eliminated 10 items. The final survey included 21 items organized into 4 composites. Conclusions:This survey measures family members’ experiences of nursing home care, and the results contribute to the understanding of quality of care in nursing homes.

Adult sickle cell quality-of-life measurement information system (ASCQ-Me): conceptual model based on review of the literature and formative research.

Objectives:Research-derived evidence about the impact of sickle cell disease (SCD) on the lives of affected adults is lacking. We conducted formative research to provide the basis for a comprehensive description of how SCD affects the lives of adults, with the goal of developing a SCD-specific quality-of-life measurement system. Methods:We conducted a comprehensive literature review of patient-reported outcomes, followed by a series of focus groups and structured individual interviews with adults with SCD (n=122) and their health care providers (n=15). Results:We reviewed 473 abstracts and included 86 articles in the final review. The literature revealed broad categories of the impact of SCD and its treatment on the lives of adults—pain; emotional distress; social-role functioning; overall quality-of-life; and quality of care. We classified 1213 incidents from the focus groups and interviews into a taxonomy (16 domains) that met the criterion for saturation and was demonstrated to be reliable for the classification of incidents. The final conceptual model was built upon the taxonomy. Discussion:Our conceptual model was similar to previous models with the effects of pain predominating, interwoven with emotional distress, quality of care, and stigmatization. We found a broad range of emotions reflected, including positive effects of SCD. Items for the quality-of-life measure were derived from the taxonomy and the conceptual model may be of use in generating hypotheses for clinical research and improving understanding for clinicians of the lived experience of adults with SCD.

Development of the Consumer Assessment of Pharmacy Services survey

OBJECTIVES To develop and test a tool for obtaining patient evaluations of the quality of pharmacy services provided in ambulatory settings. DESIGN Descriptive, exploratory, nonexperimental study. SETTING United States from June 1, 2006, through May 31, 2007. PARTICIPANTS 895 individuals who obtained prescription medications from participating pharmacies. INTERVENTION Items were evaluated for inclusion in composite scales based on factor analysis and frequency of missing data. Standard psychometric methods were used to assess the reliability and construct validity of the resulting three composite and three global-item measures. MAIN OUTCOME MEASURE Patient assessment of the quality of ambulatory care pharmacy services. RESULTS Confirmatory factor analysis indicated that a subset of 15 items measuring three aspects of pharmacy services (General Staff Communication, Health- and Medication-Focused Communication, and Clarity of Written Information about Medications) provided excellent fit to the data. Cronbachs alphas for these scales were greater than 0.80. The three scales and corresponding three global ratings of quality reliably described differences among providers of pharmacy services. CONCLUSION These data provide support for the reliability and validity of the Consumer Assessment of Pharmacy Services survey. Although preliminary results regarding reliability and validity are promising, further study of the survey is warranted.

Quality of care in sickle cell disease: Cross-sectional study and development of a measure for adults reporting on ambulatory and emergency department care.

AbstractDocumented deficiencies in adult sickle cell disease (SCD) care include poor access to knowledgeable providers and inadequate treatment in emergency departments (EDs).The aim of this study was to create patient-reported outcome measures of the quality of ambulatory and ED care for adults with SCD.We developed and pilot tested SCD quality of care questions consistent with Consumer Assessments of Healthcare Providers and Systems surveys. We applied psychometric methods to develop scores and evaluate reliability and validity.The participants of this study were adults with SCD (n = 556)—63% aged 18 to 34 years; 64% female; 64% SCD-SS—at 7 US sites.The measure used was Adult Sickle Cell Quality of Life Measurement information system Quality of Care survey.Most participants (90%) reported at least 1 severe pain episode (pain intensity 7.8 ± 2.3, 0–10 scale) in the past year. Most (81%) chose to manage pain at home rather than the ED, citing negative ED experiences (83%). Using factor analysis, we identified Access, Provider Interaction, and ED Care composites with reliable scores (Cronbach &agr; 0.70–0.83) and construct validity (r = 0.32–0.83 correlations with global care ratings). Compared to general adult Consumer Assessments of Healthcare Providers and Systems scores, adults with SCD had worse care, adjusted for age, education, and general health.Results were consistent with other research reflecting deficiencies in ED care for adults with SCD. The Adult Sickle Cell Quality of Life Measurement Quality of Care measure is a useful self-report measure for documenting and tracking disparities in quality of SCD care.

Sensitivity of alternative measures of functioning and wellbeing for adults with sickle cell disease: comparison of PROMIS® to ASCQ-Me℠

BackgroundSickle Cell Disease (SCD) causes profound suffering and decrements in daily functioning. Demand is growing for valid and reliable measures to systematically document these effects, particularly in adults. The Adult Sickle Cell Quality of Life Measurement System, ASCQ-Me℠, was developed for this purpose. ASCQ-Me℠ is one of four measurement systems housed within the Person–Centered Assessment Resource (PCAR), funded by the National Institutes of Health, to support clinical research. To help users select the best of these measures for adults with SCD, we evaluated and compared two PCAR systems: one designed to be “universally applicable” (the Patient-Reported Outcome Measurement Information System, PROMIS®) and one designed specifically for SCD (ASCQ-Me℠).MethodsRespondents to PROMIS and ASCQ-Me questions were 490 adults with SCD from seven geographically-disbursed clinics within the US. Data were collected for six ASCQ-Me measures (Emotional Impact, Sleep Impact, Social Impact, Stiffness Impact, Pain Impact, SCD Pain Episode Frequency and Severity) and ten PROMIS measures (Pain Impact, Pain Behavior, Physical Functioning, Anxiety, Depression, Fatigue, Satisfaction with Discretionary Social Activities, Satisfaction with Social Roles, Sleep Disturbance, and Sleep-Related Impairment). Statistical analyses, including analysis of variance and multiple linear regression, were conducted to determine the sensitivity of measures to SCD severity. SCD severity was assessed via a checklist of associated treatments and conditions.ResultsFor those with the most severe SCD, PROMIS scores showed worse health compared to the general population for nine of ten health domains: the magnitude of the difference ranged 0.5 to 1.1 standard deviation units. The PROMIS domains most severely affected were Physical Functioning and Pain (Impact and Behavior). Significant differences by tertile of the SCD-MHC were shown for most PROMIS short forms and all ASCQ-Me short and fixed forms. In most models, ASCQ-Me measures explained statistically significant unique variance in SCD-MHC scores complementary to that explained by corresponding PROMIS measures.ConclusionsStudy results supported the validity of both PROMIS and ASCQ-Me measures for use in adults with SCD. Compared to comparable PROMIS scores, most ASCQ-Me scores were better predictors of SCD disease severity, as measured by a medical history checklist. The clinical implications of these results require further investigation.

Formative research on patient experiences with cancer care.

274 Background: The objectives of the formative research were to identify key themes of patient-centered cancer care and determine the best method to collect data to develop the CAHPS Survey for Cancer Care Prototype. This survey seeks to measure aspects of care most important to patients and allow comparisons of those aspects across treatment centers and treatment modalities. METHODS We developed a library of 1,781 items from CAHPS and cancer care surveys. We conducted 14 focus groups with patients (including 2 conducted in Spanish) who had received cancer care in the past 12 months, and 2 focus groups involving family members of cancer patients. We met with 10 experts representing patients and survivors, or who had expertise in quality improvement, oncology, shared decision-making and patient safety to obtain feedback on the development of the survey, potential markets for the instrument, and to assist with overall strategy. Finally, we conducted separate interviews with 5 stakeholder groups representing oncology associations to obtain feedback on focal provider, attribution and sampling. RESULTS While the focus group results validated findings from the item library, new concepts also emerged, such as the need for having a plan of care. Patients most readily identified with a team of providers, rather than a single provider. The two most important domains to patients were (1) how well the cancer care team communicates with patients and (2) whether the cancer care team keeps patients informed about cancer treatment. Patients were also interested in care coordination, access to information, providers who are up-to-date, and shared decision-making. Stakeholder interviews noted that survey results would be most valuable if presented by treatment modality: medical, radiation, and surgical oncology. CONCLUSIONS These findings suggest that cancer care is best for the patient when providers are knowledgeable and straightforward with medical information, yet can demonstrate empathy and compassion.