Lidose-Isotretinoin Administered Without Food Improves Quality of Life in Patients With Severe Recalcitrant Nodular Acne: An Open-Label, Single-Arm, Phase IV Study.

OBJECTIVE: We sought to assess the impact of Lidose-isotretinoin taken without food on patient quality of life (QoL) at baseline, monthly intervals, and end of study in patients with severe recalcitrant nodular acne. DESIGN: In this open-label, single-arm, multicenter study, 197 patients took twice-daily Lidose-isotretinoin without food for 20 weeks (120-150mg/kg cumulative dosage). Patient visits occurred at Weeks 2, 4, 8, 12, 16, and 20. At baseline and Weeks 4, 8, 12, 16, and 20, patients underwent QoL and acne severity assessments and lesion counts. SETTING: Participants were enrolled from 21 sites across the United States. PARTICIPANTS: Eligible participants were 12 to 45 years of age, weighing 40 to 110kg, and with e;5 facial nodules and no prior exposure to systemic retinoids, including isotretinoin. Female participants were nonpregnant and nonlactating. MEASUREMENTS: An acne-specific QoL questionnaire (Acne-QoL) was used to assess QoL. Efficacy endpoints were lesion counts and Investigator Global Assessment (IGA) of acne severity. Safety assessments included reported adverse events. RESULTS: Lidose-isotretinoin taken without food significantly improved mean (standard deviation) overall Acne-QoL score from baseline (61.6 [28.7]) to end of treatment (101.8 [16.9]; P<0.0001). Improvements were shown in both male and female patients. Significant improvements in patient QoL (overall and by questionnaire domain), lesion counts, and IGA scores were observed as early as Week 4 and continued to improve throughout treatment. CONCLUSION: Twice-daily Lidose-isotretinoin taken without food for 20 weeks significantly improved patient QoL from Week 4.

Efficacy and Safety of OTX-101, a Novel Nanomicellar Formulation of Cyclosporine A, for the Treatment of Keratoconjunctivitis Sicca: Pooled Analysis of a Phase 2b/3 and Phase 3 Study.

BACKGROUND: OTX-101 (CEQUA™) is approved in the United States for treatment of keratoconjunctivitis sicca (KCS). This pooled analysis of 2 studies (phase 2b/3 and phase 3) evaluates the efficacy and safety of OTX-101 0.09% in the intent-to-treat (ITT) population and the subgroup of patients with a baseline Schirmer score less than 10 mm. METHODS: In these randomized, multicenter, double-masked, vehicle-controlled studies, patients received 1 drop of either OTX-101 or vehicle in both eyes twice daily. A Schirmer's test was performed at baseline and day 84/early discontinuation. Symptom Assessment iN Dry Eye (SANDE) scores and adverse events were monitored at each visit. RESULTS: The pooled analysis included 523 and 525 patients randomized to OTX-101 0.09% and vehicle, respectively. In the ITT population, 16.6% of eyes receiving OTX-101 and 9.0% of eyes receiving vehicle showed a day 84 increase in Schirmer score ≥10 mm from baseline (P<0.0001). In the subgroup with Schirmer score less than 10 mm at baseline, 18.7% and 10.2% of eyes receiving OTX-101 and vehicle, respectively, exhibited this outcome (P=0.0001). The mean (SD) percent change from baseline in global SANDE scores on day 84 in the ITT population was -29.0% (39.0%) and -30.4% (39.5%) for OTX-101 and vehicle groups, respectively. In the subgroup, the mean (SD) percent change was -27.3% (39.7%) and -31.4% (38.3%) for OTX-101 and vehicle groups, respectively. Adverse events were mostly mild to moderate. CONCLUSIONS: OTX-101 improved tear production compared with vehicle. Both OTX-101 and vehicle showed improved SANDE scores over baseline. OTX-101 was well tolerated in patients with KCS.

Effect of OTX-101, a Novel Nanomicellar Formulation of Cyclosporine A, on Conjunctival Staining in Patients with Keratoconjunctivitis Sicca: A Pooled Analysis of Phase 2b/3 and 3 Clinical Trials.

Purpose: Keratoconjunctivitis sicca (KCS), a multifactorial disease, is the most common ocular condition for patients seeking medical treatment and is characterized by ocular burning, stinging, and dryness. This pooled analysis examined the effect of OTX-101 0.09% versus vehicle on the total and individual conjunctival staining in patients with KCS from phase 2b/3 and phase 3 studies. Methods: In these randomized, multicenter, double-masked, and vehicle-controlled studies, patients received 1 drop of OTX-101 0.09% or vehicle in both eyes twice daily. The time points for the pooled analysis were baseline (day 0) and study days 28, 56, and 84/early discontinuation. Conjunctival staining was graded on a 0- to 3-point scale per zone and averaged over both eyes at each assessment. Pooled safety assessments included adverse event (AE) reporting. Results: The total mean (standard deviation) conjunctival staining scores at baseline were 5.4 (1.7) for OTX-101 (n = 523) and 5.5 (1.7) for vehicle (n = 525). OTX-101 versus vehicle significantly reduced the total conjunctival staining scores (P = 0.0316, <0.0001, and 0.0002) for days 28, 56, and 84, respectively. The most common treatment-related AE was instillation site pain (21.8% OTX-101 vs. 4.0% vehicle); most AEs were mild in nature. Conclusions: Treatment with OTX-101 versus vehicle significantly improved the conjunctival staining in KCS as early as 4 weeks, and the improvement was maintained through 12 weeks. OTX-101 was effective and well tolerated for use in KCS.

Effect of OTX-101, a Novel Nanomicellar Formulation of Cyclosporine A, on Corneal Staining in Patients With Keratoconjunctivitis Sicca: A Pooled Analysis of Phase 2b/3 and Phase 3 Studies.

BACKGROUND: Keratoconjunctivitis sicca affects 5% to 33% of the population and is often accompanied by symptoms such as burning and dryness. This pooled analysis evaluated total and central corneal fluorescein staining (CFS) in patients receiving OTX-101 0.09% or vehicle in phase 2b/3 and 3 studies and whether improvements in corneal staining correlated with improved visual acuity. METHODS: In these randomized, vehicle-controlled studies, patients received 1 drop of OTX-101 or vehicle in both eyes twice daily. Corneal staining was performed at baseline and days 28, 56, and 84. CFS was evaluated in each zone (0-to-4 scale); total corneal staining (0-to-20 scale per eye) was averaged over both eyes. Pooled safety assessments included adverse event monitoring. RESULTS: Mean baseline CFS total scores (SD) were 4.2 (2.5) and 4.3 (2.6) for the OTX-101 (n = 523) and vehicle (n = 525) groups, respectively. For total corneal staining, least squares mean changes from baseline (standard error) were -0.9 (0.08) versus -0.5 (0.08) for OTX-101 and vehicle, respectively (P = 0.0008), on day 28 and -1.4 (0.09) versus -0.9 (0.09) on day 84 (P = 0.0002). There was a significantly high correlation (P = 0.0117) between reduced central corneal staining and improved visual acuity on day 84. Treatment-related adverse events were mostly mild, with instillation site pain reported by 21.8% and 4.0% of patients receiving OTX-101 and vehicle, respectively. CONCLUSIONS: Treatment with OTX-101 led to greater improvements versus vehicle in corneal surface staining as early as 4 weeks, and further improvements were seen up to 12 weeks. OTX-101 was well tolerated in patients with keratoconjunctivitis sicca.

Adapting CAHPS for an American Indian population.

OBJECTIVE: Develop a culturally appropriate, reliable, and valid survey that can be used by the Choctaw Nation Health Services (CNHS) to compare patients' health care experiences across CNHS clinics, and to support quality improvement efforts. METHODS: We worked with CNHS staff to adapt the CAHPS Clinician and Group Survey for this purpose. We conducted cognitive interviews and a field-test to evaluate the survey. RESULTS: Cognitive testing yielded a survey that covered issues relevant to CNHS patients. Field testing yielded 696 surveys, (58% response rate). Analyses provided support for internal consistency of multi-item scales. Correlations among scales indicate the scales were related to one another but not redundant. DISCUSSION: The CAHPS American Indian Survey is useful for assessing perceptions of care at the clinic level and across different clinics. The close partnership with CNHS helped yield a survey that is scientifically sound, reflects how services are organized and delivered locally, and meets CNHS information needs.

Which aspects of non-clinical quality of care are most important? Results from WHO's general population surveys of "health systems responsiveness" in 41 countries.

Quality of care research has reached some agreement on concepts like structure, process and outcome, and non-clinical versus clinical processes of care. These concepts are commonly explored through surveys measuring patient experiences, yet few surveys have focused on patient, or "user", priorities across different quality dimensions. Population surveys on priorities can contribute to, although not replace participation in, policy decision making. Using 105,806 survey interview records from the World Health Organization's (WHO's) general population surveys in 41 countries, this paper describes the relative importance of eight domains in the non-clinical quality of care concept WHO calls "health systems responsiveness". Responsiveness domains are divided into interpersonal domains (dignity, autonomy, communication and confidentiality) and structural domains (quality of basic amenities, choice, access to social support networks and prompt attention). This paper explores variations in domain importance by country-level variables (country of residence, human development, health system expenditure, and "geographic zones") and by subpopulations defined by sex, age, education, health status, and utilization. Most respondents selected prompt attention as the most important domain. Dignity was selected second, followed by communication. Access to social support networks was identified as the least important domain. In general, convergence in rankings was stronger across subpopulations within countries than across countries. Yet even across diverse countries, there was more convergence than divergence in views. These results provide a ranking of quality of care criteria for consideration during health reform processes further to the usual emphasis on clinical quality and supply-side efficiency.

Racial and ethnic differences in patient assessments of interactions with providers: disparities or measurement biases?

Patient assessment surveys have established a primary role in health care quality measurement as evidence has shown that information from patients can affect quality improvement for practitioners and lead to positive marketwide changes. This article presents findings from the recently released National Healthcare Disparities Report revealing that although most clinical quality and access indicators show superior health care for non-Hispanic whites compared with blacks and Hispanics, blacks and Hispanics assess their interactions with providers more positively than non-Hispanic whites do. The article explores possible explanations for these racial/ethnic differences, including potential pitfalls in survey design that draw biased responses by race/ethnicity. The article then suggests strategies for refining future research on racial/ethnic disparities based on patient assessment of health care.

The CAHPS Hospital Survey: development, testing, and use.

The CAHPS Hospital Survey was designed to provide valid and reliable assessments from patients about their hospital care experiences--and yet minimize the cost for hospitals and the burden for survey respondents.

Measuring hospital care from the patients' perspective: an overview of the CAHPS Hospital Survey development process.

OBJECTIVE: To describe the developmental process for the CAHPS Hospital Survey. STUDY DESIGN: A pilot was conducted in three states with 19,720 hospital discharges. METHODS OF ANALYSIS: A rigorous, multi-step process was used to develop the CAHPS Hospital Survey. It included a public call for measures, multiple Federal Register notices soliciting public input, a review of the relevant literature, meetings with hospitals, consumers and survey vendors, cognitive interviews with consumer, a large-scale pilot test in three states and consumer testing and numerous small-scale field tests. FINDINGS: The current version of the CAHPS Hospital Survey has survey items in seven domains, two overall ratings of the hospital and five items used for adjusting for the mix of patients across hospitals and for analytical purposes. CONCLUSIONS: The CAHPS Hospital Survey is a core set of questions that can be administered as a stand-alone questionnaire or combined with a broader set of hospital specific items.

Radioactive seed migration to the chest after transperineal interstitial prostate brachytherapy: extraprostatic seed placement correlates with migration.

PURPOSE: To examine the incidence of seed migration detected on chest X-ray and to identify the predictors associated with its occurrence. METHODS AND MATERIALS: Between May 1998 and April 2000, 102 patients underwent permanent prostate brachytherapy at our institution and 100 were eligible for the study. Chest X-rays obtained at follow-up were examined for the number and location of seeds. The patient and treatment variables potentially associated with the occurrence and number of seed migrations were analyzed. RESULTS: One or more seeds were identified on the chest X-rays of 55 (55%) of 100 patients. The mean number of intrathoracic seeds in patients with migration was 2.2 (range, 1-10), and the proportion of seeds that migrated to the thorax was 0.98%. The rate of extraprostatic seeds planned was 43.9%, and postimplant CT identified 37.9% in such a location. The number of seeds planned for extraprostatic placement and below the apex were statistically significant (alpha = 0.05) predictors in univariate logistic analysis. Multivariate analysis revealed the planned number of extraprostatic seeds as the only statistically significant predictor (p = 0.04). CONCLUSION: Extraprostatic placement of loose seeds is associated with an increased likelihood for, and frequency of, seed migration to the thorax. Nonetheless, the small proportion of implanted seeds that migrated (

Patient/parent assessment of the quality of care.

Providing patient-centered care is an accepted goal in medicine today. Focusing on the patient has drawn attention to the importance of the interpersonal aspects of care, such as communication between the health care provider and patient, or in the case of health care for children, the parent and child. Patients or parents may be the best or only source of information for assessing the personal aspects of care. In research on children, parents generally report on and evaluate the care. Assessing the interpersonal aspects of care has traditionally been referred to as the measurement of patient satisfaction. The varying expectations of patients and the presence of a ceiling effect on the measures often confound the use of patient satisfaction measures for evaluating the quality of care. One trend is to ask respondents to report on the interpersonal aspects of care, rather than to respond about their level of satisfaction. Studies on the assessment of the interpersonal aspects of health care in emergency departments for children are not plentiful. However, research provides some insight into ways in which emergency departments might improve interpersonal aspects of care for children. These include providing a clear picture to patients and parents of what to expect regarding the length of time they will have to wait, taking a caring approach with children and their parents, and explaining clearly to parents what they need to do to care for the child after discharge.