Focus Groups to Inform the Development of a Patient-Reported Outcome Measure (PROM) for Temporomandibular Joint Disorders (TMDs).

BACKGROUND: Understanding symptoms of temporomandibular joint disorders (TMDs) can help doctors and patients document, monitor, and manage the disease and help researchers evaluate interventions. Patients with TMDs experience symptoms ranging from mild to severe, primarily in the head and neck region. This study describes findings from formative patient focus groups to capture, categorize, and prioritize symptoms of TMDs towards the development of a patient-reported outcome measure (PROM). METHODS: We conducted ten focus groups with 40 men and women with mild, moderate, and severe TMD. Focus groups elicited descriptions of symptoms and asked participants to review a list of existing patient-reported outcomes (PROs) from the literature and patient advisor input and speak to how those PROs reflect their own experience, including rating their importance. RESULTS: We identified 52 distinct concepts across six domains: somatic, physical, social, sexual, affective, and sleep. Focus groups identified the ability to chew and eat; clicking, popping, and other jaw noises; jaw pain and headaches; jaw misalignment or dislocation; grinding, clenching, or chewing, including at night; and ear sensations as most important. Participants with severe TMDs more often reported affective concepts like depression and shame than did participants with mild or moderate TMDs. CONCLUSION: Findings support PROM item development for TMDs, including selecting existing PROMs or developing new ones that reflect patients' lived experiences, priorities, and preferred terminology. Such measures are needed to increase understanding of TMDs, promote accurate diagnosis and effective treatment, and help advance research on TMDs.

Patients with temporomandibular joint disorders, or TMDs, have pain and other problems in their jaw, and face and neck areas. We talked to 40 patients with mild, moderate, and severe TMDs to learn about their symptoms. We also asked patients to review a list of TMD symptoms. They then chose the most important ones based on their experience. The data showed 52 TMD symptoms and functions across six domains. The patients chose the ability to chew and eat; clicking, popping, and other jaw noises; and jaw pain and headaches as most important. They also chose jaw misalignment or dislocation; grinding, clenching, or chewing, including at night; and ear feelings as important. Findings support creating patient-reported outcome measures, or PROMs, for TMDs. These PROMs should reflect patients' experiences and what is most important to them. Such measures can help doctors treat TMDs and help advance research on TMDs.

Differential Item Functioning of the Jaw Functional Limitation Scale

AIMS: To assess the differential item functioning (DIF) of the Jaw Functional Limitation Scale (JFLS) due to gender, age, and language (English vs Spanish). METHODS: JFLS data were collected from a consecutive sample of 2,115 adult dental patients from HealthPartners dental clinics in Minnesota. Participants with missing data were excluded, and analyses were performed using data from 1,678 participants. Whether the item response theory (IRT) model assumptions of essential unidimensionality and local independence held up for the JFLS was examined. Then, using Samejima's graded response model, the IRT log-likelihood ratio approach was used to detect DIF. The magnitude and impact of DIF based on Raju's noncompensatory DIF (NCDIF) cutoff value of 0.096, Cohen's effect sizes, and test (or scale) characteristic curves were also assessed. RESULTS: Essential unidimensionality was confirmed, but locally dependent items were found on the JFLS. A few items were flagged with statistically significant DIF after adjustment for multiple comparisons. The NCDIF indices associated with all DIF items were < 0.096, and they had small effect sizes of ≤ 0.2. The differences between the expected scores shown in the test characteristic curves were little to none. CONCLUSION: The present results support the use of the JFLS summary score to obtain psychometrically robust score comparisons across English- and Spanish-speaking, male and female, and younger and older dental patients. Overall, the magnitude of DIF was relatively small, and the practical impact minimal.

Health following recovery from immune thrombotic thrombocytopenic purpura: the patient's perspective.

The impact of residual symptoms following recovery from immune-mediated thrombotic thrombocytopenic purpura (iTTP) on activities of daily living during remission is not routinely discussed or evaluated by hematologists. This study used qualitative methodology to understand 3 issues from the patient's perspective: the most important symptoms during remission, the impact of these symptoms on their daily activities, and the effectiveness of communication with hematologists. Oklahoma and Ohio patients participated in either focus groups or individual interviews. Eligibility included age ≥18 years, ADAMTS13 deficiency (<10% activity) at diagnosis or relapse, and in clinical remission (≥1 year from episode). A nonprobabilistic purposive sampling approach was used. The most important symptoms were defined as symptoms mentioned across all 7 focus groups. The interviews supplemented focus group data. The analysis focused on describing the impact of symptoms and barriers to communicating with hematologists. A total of 44 patients participated (focus groups, N = 25; interviews, N = 19). The most important symptoms affecting the patients' daily activities were cognitive issues, anxiety, depression, and fatigue. These symptoms affected patients' ability to return to their previous level of functioning and created difficulties in relationships. A key communication barrier with their hematologists was forgetting to mention these symptoms. Although hematologists pronounce patients as recovered, iTTP remains a life-changing event. Patients often did not return to their previous functioning; relationships and careers were affected. However, patients may forget to discuss these concerns with their hematologist. To improve remission care, hematologists should incorporate patient-reported outcome measures evaluating these symptoms in remission visits.

Patient-reported outcome measures for individuals with temporomandibular joint disorders: a systematic review and evaluation.

OBJECTIVE: We used consensus-based, systematic protocols to evaluate the reliability and validity of patient-reported outcome measures (PROMs) for use in documenting treatment outcomes for temporomandibular disorders (TMDs). STUDY DESIGN: Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, we conducted a focused search of 5 literature databases resulting in a yield of 445 articles that qualified for full-text review. Our review identified 124 PROMs, from which we selected 19 directly related to symptoms of TMD including temporomandibular joint (TMJ) function. RESULTS: We abstracted data on 9 Consensus-based Standards of the selection of health Measurements INstruments (COSMIN) measurement properties and analyzed these data according to COSMIN criteria. Only 3 PROMs provided evidence for at least half of the COSMIN properties: Eight-item Jaw Function Limitations Scale, Oral Health Impact Profile (OHIP)-TMD (OHIP-TMD), and TMJ Ankylosis Specific Quality of Life Questionnaire. Only the OHIP-TMD provided evidence for properties essential to evaluating change over time: reliability, measurement error, and responsiveness. CONCLUSION: We believe these results can alert clinical practitioners to gaps in our knowledge about the most widely used PROMs in TMD practice, and identify topics requiring further study for clinical researchers.

Comparison of two rating scales with the orofacial esthetic scale and practical recommendations for its application.

PURPOSE: We compared measurement properties of 5-point and 11-point response formats for the orofacial esthetic scale (OES) items to determine whether collapsing the format would degrade OES score precision. METHODS: Data were collected from a consecutive sample of adult dental patients from HealthPartners dental clinics in Minnesota (N = 2,078). We fitted an Item Response Theory (IRT) model to the 11-point response format and the six derived 5-point response formats. We compared all response formats using test (or scale) information, correlation between the IRT scores, Cronbach's alpha estimates for each scaling format, correlations based on the observed scores for the seven OES items and the eighth global item, and the relationship of observed and IRT scores to an external criterion using orofacial appearance (OA) indicators from the Oral Health Impact Profile (OHIP). RESULTS: The correlations among scores based on the different response formats were uniformly high for observed (0.97-0.99) and IRT scores (0.96-0.99); as were correlations of both observed and IRT scores and the OHIP measure of OA (0.66-0.68). Cronbach's alpha based on any of the 5-point formats (α = 0.95) was nearly the same as that based on the 11-point format (α = 0.96). The weighted total information area for five of six derived 5-point response formats was 98% of that for the 11-point response format. CONCLUSIONS: Our results support the use of scores based on a 5-point response format for the OES items. The measurement properties of scores based on a 5-point response format are comparable to those of scores based on the 11-point response format.

Assessing sleep and pain among adults with myalgic encephalomyelitis/chronic fatigue syndrome: psychometric evaluation of the PROMIS® sleep and pain short forms.

PURPOSE: To evaluate the psychometric properties of the patient-reported outcome measurement information system® (PROMIS) short forms for assessing sleep disturbance, sleep-related impairment, pain interference, and pain behavior, among adults with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). METHODS: Data came from the Multi-Site ME/CFS study conducted between 2012 and 2020 at seven ME/CFS specialty clinics across the USA. Baseline and follow-up data from ME/CFS and healthy control (HC) groups were used to examine ceiling/floor effects, internal consistency reliability, differential item functioning (DIF), known-groups validity, and responsiveness. RESULTS: A total of 945 participants completed the baseline assessment (602 ME/CFS and 338 HC) and 441 ME/CFS also completed the follow-up. The baseline mean T-scores of PROMIS sleep and pain measures ranged from 57.68 to 62.40, about one standard deviation above the national norm (T-score = 50). All four measures showed high internal consistency (ω = 0.92 to 0.97) and no substantial floor/ceiling effects. No DIF was detected by age or sex. Known-groups comparisons among ME/CFS groups with low, medium, and high functional impairment showed significant small-sized differences in scores (η2 = 0.01 to 0.05) for the two sleep measures and small-to-medium-sized differences (η2 = 0.01 to 0.15) for the two pain measures. ME/CFS participants had significantly worse scores than HC (η2 = 0.35 to 0.45) for all four measures. Given the non-interventional nature of the study, responsiveness was evaluated as sensitivity to change over time and the pain interference measure showed an acceptable sensitivity. CONCLUSION: The PROMIS sleep and pain measures demonstrated satisfactory psychometric properties supporting their use in ME/CFS research and clinical practice.

Conceptual Framework for Patient-Reported Outcome Measures in Clinical Trials of Skeletal Muscle Cramping Experienced in Dialysis: A Kidney Health Initiative Workgroup Report.

Skeletal muscle cramping is a common and bothersome symptom for patients on maintenance dialysis therapy, regardless of modality, and it has not been prioritized for innovative assessments or treatments. Research to prevent or treat skeletal muscle cramping in patients receiving dialysis is hindered by poorly understood pathophysiology, lack of an accepted definition, and the absence of a standardized measurement method. The Kidney Health Initiative, a public-private partnership between the American Society of Nephrology and US Food and Drug Administration, convened a multidisciplinary workgroup to define a set of patient-reported outcome measures for use in clinical trials to test the effect of new dialysis devices, new KRTs, lifestyle/behavioral modifications, and medications on skeletal muscle cramping. Upon determining that foundational work was necessary, the workgroup undertook a multistep process to elicit concepts central to developing the basis for demonstrating content validity of candidate patient-reported outcome measures for skeletal muscle cramping in patients on dialysis. The workgroup sought to (1) create an accepted, patient-endorsed definition for skeletal muscle cramping that applies to all dialysis modalities, (2) construct a conceptual model for developing and evaluating a skeletal muscle cramping-specific patient-reported outcome measure, and (3) identify potential questions from existing patient-reported outcome measures that could be modified or adapted and subsequently tested in the dialysis population. We report the results of the workgroup's efforts, provide our recommendations, and issue a call to action to address the gaps in knowledge and research needs we identified. These action steps are urgently needed to quantify skeletal muscle cramping burden, assess the effect, and measure meaningful changes of new interventions to improve the experience of patients receiving dialysis and suffering from skeletal muscle cramping.

Should the frequency, severity, or both response scales be used for multi-item dental patient-reported outcome measures?

BACKGROUND: The Oral Impacts on Daily Performances (OIDP) index asks the respondents to indicate both, the frequency and severity of the impact. However, it is not clear if the two scaling methods are correlated, and if using one scale is sufficient. The purpose of the study was to investigate the correlation between frequency and severity rating scales of the OIDP instrument, and whether only one of the rating scales can be used instead of both. METHODS: A battery of patient-reported outcome questionnaires were administered to a consecutive sample of adult dental patients from HealthPartners dental clinics in Minnesota (N = 2,115). Only those who responded to any of the OIDP items were included in the analysis for this study (N = 873). We assessed correlations between the frequency and severity scales for all OIDP items, and for the summary scores of the two OIDP response scales. We additionally fit a categorical structural equation model (SEM) (or an item factor analysis model) and examined the correlation between two latent variables (Frequency and Severity). RESULTS: The correlation estimates for all OIDP items were greater than 0.50, indicating large correlations between the frequency and severity scores for each OIDP item. The correlation estimate between the two summary scores was 0.85 (95% CI [0.82-0.86]). When we calculated the correlation coefficient using a latent variable model, the value increased to 0.96 (95% CI [0.93-1.00]). CONCLUSION: Our study findings show that OIDP frequency and severity scores are highly correlated, which indicates the use of one scale only. Based on previous evidence, we recommend applying the frequency rating scale only in research and clinical settings.

Selecting Patient-Reported Outcome Measures to Contribute to Primary Care Performance Measurement: a Mixed Methods Approach.

New models of primary care include patient-reported outcome measures (PROMs) to promote patient-centered care. PROMs provide information on patient functional status and well-being, can be used to enhance care quality, and are proposed for use in assessing performance. Our objective was to identify a short list of candidate PROMs for use in primary care practice and to serve as a basis for performance measures (PMs). We used qualitative and quantitative methods to identify relevant patient-reported outcome (PRO) domains for use in performance measurement (PRO-PM) and their associated PROMs. We collected data from key informant groups: patients (n = 13; one-on-one and group interviews; concept saturation analysis), clinical thought leaders (n = 9; group discussions; thematic analysis), primary care practices representatives (n = 37; six focus groups; thematic analysis), and primary care payer representatives (n = 10; 12-question survey; frequencies of responses). We merged the key informant group information with findings from environmental literature scans. We conducted a targeted evidence review of measurement properties for candidate PROMs. We used a scoping review and key informant groups to identify PROM evaluation criteria, which were linked to the National Quality Forum measure evaluation criteria. We developed a de novo schema to score candidate PROMs against our criteria. We identified four PRO domains and 10 candidate PROMs: 3 for depressive symptoms, 2 for physical function, 3 for self-efficacy, 2 for ability to participate. Five PROMs met ≥ 70% of the evidence criteria for three PRO domains: PHQ-9 or PROMIS Depression (depression), PF-10 or PROMIS-PF (physical functioning), and PROMIS Self-Efficacy for Managing Treatments and Medications (self-efficacy). The PROMIS Ability to Participate in Social Roles and Activities met 68% of our criteria and might be considered for inclusion. Existing evidence and key informant data identified 5 candidate PROMs to use in primary care. These instruments can be used to develop PRO-PMs.

Toward Patient-Centered Innovation: A Conceptual Framework for Patient-Reported Outcome Measures for Transformative Kidney Replacement Devices.

Individuals with dialysis-dependent kidney failure experience considerable disease- and treatment-related decline in functional status and overall well-being. Despite these experiences, there have been few substantive technological advances in KRT in decades. As such, new federal initiatives seek to accelerate innovation. Historically, integration of patient perspectives into KRT product development has been limited. However, the US Food and Drug Administration recognizes the importance of incorporating patient perspectives into the total product life cycle (i.e., from product conception to postmarket surveillance) and encourages the consideration of patient-reported outcomes in regulatory-focused clinical trials when appropriate. Recognizing the significance of identifying patient-reported outcome measures (PROMs) that capture contemporary patient priorities, the Kidney Health Initiative, a public-private partnership between the American Society of Nephrology and US Food and Drug Administration, convened a workgroup to (1) develop a conceptual framework for a health-related quality of life PROM; (2) identify and map existing PROMs to the conceptual framework, prioritizing them on the basis of their supporting evidence for use in the regulatory environment; and (3) describe next steps for identifying PROMs for use in regulatory clinical trials of transformative KRT devices. This paper summarizes the proposed health-related quality-of-life PROM conceptual framework, maps and prioritizes PROMs, and identifies gaps and future needs to advance the development of rigorous, meaningful PROMS for use in clinical trials of transformative KRT devices.

Psychometric properties of the PROMIS® Fatigue Short Form 7a among adults with myalgic encephalomyelitis/chronic fatigue syndrome.

PURPOSE: To evaluate the psychometric properties of the Patient-Reported Outcome Measurement Information System® Fatigue Short Form 7a (PROMIS F-SF) among people with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). METHODS: Analyses were conducted using data from the Multi-Site Clinical Assessment of ME/CFS study, which recruited participants from seven ME/CFS specialty clinics across the US. Baseline and follow-up data from ME/CFS participants and healthy controls were used. Ceiling/Floor effects, internal consistency reliability, differential item functioning (DIF), known-groups validity, and responsiveness were examined. RESULTS: The final sample comprised 549 ME/CFS participants at baseline, 386 of whom also had follow-up. At baseline, the sample mean of PROMIS F-SF T-score was 68.6 (US general population mean T-score of 50 and standard deviation of 10). The PROMIS F-SF demonstrated good internal consistency reliability (Cronbach's α = 0.84) and minimal floor/ceiling effects. No DIF was detected by age or sex for any item. This instrument also showed good known-groups validity with medium-to-large effect sizes (η2 = 0.08-0.69), with a monotonic increase of the fatigue T-score across ME/CFS participant groups with low, medium, and high functional impairment as measured by three different variables (p < 0.01), and with significantly higher fatigue T-scores among ME/CFS participants than healthy controls (p < 0.0001). Acceptable responsiveness was found with small-to-medium effect sizes (Guyatt's Responsiveness Statistic = 0.28-0.54). CONCLUSIONS: Study findings support the reliability and validity of PROMIS F-SF as a measure of fatigue for ME/CFS and lend support to the drug development tool submission for qualifying this measure to evaluate therapeutic effect in ME/CFS clinical trials.

Development and Testing of the CAHPS Cancer Care Survey.

PURPOSE: The Consumer Assessment of Healthcare Providers and Systems (CAHPS) Cancer Care Survey is a systematic assessment of health care experiences of patients with cancer. It supports comparisons among all cancer treatment settings and modalities. METHODS: Formative research included 16 focus groups with patients receiving treatment and family members; advice from a panel of oncology and quality improvement experts; and interviews with stakeholders representing oncology associations, accredited cancer centers, and community oncology practices. We conducted cognitive tests of the instrument and field tests at six cancer centers and four community oncology practices, after which the survey was finalized and obtained the CAHPS trademark. RESULTS: The survey includes 56 questions that form six core composite measures (Getting Timely Care; Supporting Patient Self-Management; Available to Provide Care and Information; Provider Communication; Care Coordination; and Courteous Office Staff); two single-item measures of family participation in care and interpreter services; and two global ratings of cancer care and the treatment team. Sixteen additional items form three supplemental composite measures: Shared Decision-Making, Keeping Patients Informed, and Access to Care. CONCLUSION: Mail-only, mail-telephone mixed-mode, and Web-mail mixed-mode data collection methods are recommended. The questionnaires and instructions for use are free and available in English and Spanish on the CAHPS Website (www.ahrq.gov/cahps).

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

BACKGROUND: Sickle 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℠). METHODS: Respondents 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. RESULTS: For 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. CONCLUSIONS: Study 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.

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

Documented 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 ±â€Š2.3, 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 α 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.

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

BACKGROUND: Providers 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). METHODS: At 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. RESULTS: Of 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. CONCLUSION: ASCQ-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.

Development and evaluation of the CAHPS (Consumer Assessment of Healthcare Providers and Systems) survey for in-center hemodialysis patients.

BACKGROUND: The US Centers for Medicare & Medicaid Services assess patient experiences of care as part of the end-stage renal disease prospective payment system and Quality Incentive Program. This article describes the development and evaluation of the Consumer Assessment of Healthcare Providers and Systems (CAHPS) In-Center Hemodialysis Survey. STUDY DESIGN: We conducted formative research to generate survey questions and performed statistical analyses to evaluate the survey's measurement properties. SETTING & PARTICIPANTS: Formative research included focus groups, cognitive interviews, and field testing the survey with dialysis patients. MEASUREMENTS & OUTCOMES: We assessed internal consistency reliability (Cronbach alpha) and center-level reliability for 3 multi-item scales. We evaluated construct validity using correlations of the scales with global ratings of the kidney doctor, staff, and dialysis center. RESULTS: Response rate was 46% (1,454 completed surveys). Analyses support 3 multi-item scales: Nephrologists' Communication and Caring (7 items, alpha=0.89), Quality of Dialysis Center Care and Operations (22 items, alpha=0.93), and Providing Information to Patients (11 items, alpha=0.75). The communication scale was correlated the most strongly with the global rating of the "kidney doctor" (r=0.78). The Dialysis Center Care and Operations scale was correlated most strongly with global ratings of staff (r=0.75) and the center (r=0.69). Providing Information to Patients was correlated most strongly with the global rating of the staff (r=0.41). LIMITATIONS: A relatively small number of patients completed the survey in Spanish. CONCLUSIONS: This study provides support for the reliability and validity of the CAHPS In-Center Hemodialysis Survey for assessing patient experiences of care at dialysis facilities. The survey can be used to compare care provided at different facilities.

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.

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.

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. Cronbach's 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.