Real-world outcomes post-transition to once-every-3-months paliperidone palmitate in patients with schizophrenia within US commercial plans

Objectives: To compare comorbidity-related outcomes, adherence to antipsychotics (APs), healthcare resource utilization (HRU), and costs pre- and post-transition to once-every-3-months paliperidone palmitate (PP3M) in commercially-insured patients with schizophrenia.

Methods: Adults with ≥1 claim for PP3M, ≥2 schizophrenia diagnoses, and adequate treatment with once-monthly paliperidone palmitate (PP1M; i.e. no gap of >45?days in PP1M coverage for ≥4?months, same PP1M dosage for the last two PP1M claims, and appropriate PP1M to PP3M dosing conversion) were selected from the IQVIA PharMetrics Plus database (May 2014–February 2018). Generalized estimating equation models adjusted for repeated measurements were used to compare patient characteristics, adherence to APs, HRU, and costs during the 6-month period pre- vs post-transition to PP3M.

Results: Of 152 included patients, the mean age was 41.0?years and 36.2% were females. Post-PP3M transition, patients were less likely to have a claim with a diagnosis for substance-related and addictive disorders (odds ratio [OR]?=?0.57), psychoses (OR?=?0.57), diabetes without chronic complication (OR?=?0.72), and drug abuse (OR?=?0.64; all p?<?.05). Patients were more likely to be adherent to APs (OR?=?2.01, p?=?.007), compared to the period pre-PP3M transition. There was no significant difference in HRU pre- vs post-transition. All-cause total (mean monthly cost difference [MMCD]?=?$242), pre-rebate pharmacy (MMCD?=?$65), and medical costs (MMCD?=?$176) remained similar pre- vs post-transition (all p?>?.05).

Conclusions: Transitioning to PP3M was associated with an improvement in adherence and in comorbidity-related outcomes related to substance-related and addictive disorders, psychoses, diabetes without chronic complication, and drug abuse. These findings suggest PP3M may enhance comorbidity-related outcomes and adherence while remaining cost neutral.     

Blood Pressure Assessments in Different Subtypes of Hypertensive Pregnant Women: Office Versus Home Patient- or Nurse-Measured Blood Pressure

Objective:?To explore the difference between distinct methods of assessing blood pressure (BP) in pregnant women with different hypertensive disorders.?Methods:?We compared office BP to home patient- and nurse-measured diastolic BP in pregnant women with essential chronic hypertension (CH), preeclampsia (PE) and isolated hypertension (IOH).?Results:?Office BP was lower or similar to home patient- and nurse-measured BP in women with CH. Office BP was higher than home patient-measured BP in women with PE and in women with IOH (p < 0.0001). Nurse-measured BP was higher than patient-measured BP in women with PE (p < 0.01).?Conclusions:?BP assessments in women with PE are significantly influenced by the environment, which should be considered in managing these women.     

Assessing diabetic foot ulcer development risk with hyperspectral tissue oximetry

Foot ulceration remains a serious health concern for diabetic patients and has a major impact on the cost of diabetes treatment. Early detection and preventive care, such as offloading or improved hygiene, can greatly reduce the risk of further complications. We aim to assess the use of hyperspectral tissue oximetry in predicting the risk of diabetic foot ulcer formation. Tissue oximetry measurements are performed during several visits with hyperspectral imaging of the feet in type 1 and 2 diabetes mellitus subjects that are at risk for foot ulceration. The data are retrospectively analyzed at 21 sites that ulcerated during the course of our study and an ulceration prediction index is developed. Then, an image processing algorithm based on this index is implemented. This algorithm is able to predict tissue at risk of ulceration with a sensitivity and specificity of 95 and 80%, respectively, for images taken, on average, 58 days before tissue damage is apparent to the naked eye. Receiver operating characteristic analysis is also performed to give a range of sensitivity/specificity values resulting in a Q-value of 89%.     

Auditory arousal responses and thresholds during REM and NREM sleep of sleepwalkers and controls

BackgroundIt has been suggested that sleepwalkers are more difficult to awaken from sleep than are controls. However, no quantified comparisons have been made between these two populations. The main goal of this study was to assess arousal responsiveness via the presentation of auditory stimuli (AS) in sleepwalkers and controls during normal sleep and recovery sleep following sleep deprivation.MethodsTen adult sleepwalkers and 10 age-matched control subjects were investigated. After a screening night, participants were presented with AS during slow-wave sleep (SWS), REM, and stage 2 sleep either during normal sleep or daytime recovery sleep following 25 h of sleep deprivation. The AS conditions were then reversed one week later.ResultsWhen compared to controls sleepwalkers necessitated a significantly higher mean AS intensity (in dB) to induce awakenings and arousal responses during REM sleep whereas the two groups’ mean values did not differ significantly during SWS and stage 2 sleep. Moreover, when compared to controls sleepwalkers had a significantly lower mean percentage of AS that induced arousal responses during REM sleep while the opposite pattern of results was found during SWS.ConclusionsThe data indicate that sleepwalkers have a higher auditory awakening threshold than controls, but only for REM sleep. These findings may reflect a compensatory mechanism of the homeostatic process underlying sleep regulation during sleepwalkers’ REM sleep in reaction to their difficulties maintaining consolidated periods of NREM sleep.     

Psychometric Properties of an Assessment for Mental Health Recovery Programs

The concept of recovery can be operationalized from either the point of view of the consumer, or from the perspective of the agency providing services. The Milestones of Recovery Scale (MORS) was created to capture aspects of recovery from the agency perspective. Evidence establishing the psychometric properties of the MORS was obtained in three efforts: Inter-rater reliability using staff at The Village, a multi-service organization serving the homeless mentally ill in Long Beach, California; inter-rater reliability was also obtained from Vinfen Corporation, a large provider of housing services to mentally ill persons in Boston, Massachusetts. A test–retest reliability study was conducted using staff rating of clients at The Village, and evidence for validity was obtained using the Level of Care Utilization System (LOCUS) as a validity measure. The intra-class correlation coefficient for the inter-rater reliability study was r = .85 (CI .81, .89) for The Village and r = .86 (CI .80, .90) for Vinfen Corporation; test–retest reliability was r = .85 (CI .81, .87); and validity coefficients for the LOCUS were at or above r = .49 for all subscales except one. There is sufficient evidence for the reliability and validity of the MORS.     

Efficient Diagnosis of Vulvovaginal Candidiasis by Use of a New Rapid Immunochromatography Test

The clinical symptoms of vulvovaginal candidiasis (VVC) are nonspecific, and misdiagnosis is common, leading to a delay in the initiation of antifungal treatment. We evaluated a new immunochromatography test (ICT), the CandiVagi assay (SR2B, Avrille, France), for the rapid diagnosis of VVC. This test, which employs an immunoglobulin M antibody directed against the β-1,2-mannopyranosyl epitopes found in the yeast cell wall, was compared with direct microscopic examination and culture of vaginal swabs. Two-hundred five women were investigated, including 130 women with symptomatic vaginitis and 75 asymptomatic controls. Two vaginal swabs were obtained from each woman: one was used to prepare a wet mount and Gram-stained preparations for direct microscopic examination and was also cultured on Sabouraud dextrose agar for the isolation of Candida spp., and the second swab was used for ICT. The sensitivities of microscopic examination, culture, and ICT for the diagnosis of VVC were 61%, 100%, and 96.6%, respectively, while the specificities of the three methods were 100%, 82%, and 98.6%, respectively. ICT had a negative predictive value of 98.6%, a positive predictive value of 96.6%, and an efficiency of 98%. ICT provided a rapid result and a better compromise between sensitivity and specificity than conventional microscopy and culture for the diagnosis of VVC. This easy-to-perform diagnostic test will be useful to practitioners treating women with symptoms of vaginitis.Vaginitis is the commonest reason for gynecological consultation in women of childbearing age. Anaerobic bacteria are the most prevalent cause of vaginal infection in the United States and Europe, followed closely by Candida spp. (34, 37). It is estimated that at least 75% of healthy adult women will suffer one episode of Candida vulvovaginitis during their reproductive lives and that 5% will have recurrent infectious episodes (20, 30). Candida albicans is responsible for infection in 80 to 90% of cases, although the incidence of vulvovaginal candidiasis (VVC) due to non-C. albicans species such as C. glabrata has increased steadily over the past few decades (21, 36).The main symptoms of VVC have been widely described and include vulvar and vaginal pruritus, pain or a burning sensation, and external dysuria (8). Physical examination may reveal perineal edema, vulvar and vaginal erythema, fissures, and a thick curdy discharge (8). However, these symptoms are nonspecific and do not enable clinicians to distinguish confidently between VVC, bacterial vaginosis, and Trichomonas vaginalis infection (2, 22, 23, 31), leading to subsequent suboptimal care. The accurate diagnosis of VVC currently depends on the demonstration of a Candida sp. in vaginal swabs by direct microscopic examination and/or culture. A positive Gram stain, the absence of a watery discharge, and patient self-diagnosis of “another yeast infection” have been identified as the best predictors of a positive culture for patients with VVC (1).Several rapid diagnostic tests have been developed over the past 25 years in an attempt to speed up the diagnosis of VVC (17, 29). Latex particle agglutination (LPA) was found to be more sensitive than KOH microscopy (19, 28, 29) and was more specific than other diagnostic criteria (10). However, a few studies reported false-positive reactions with this test (39) or a sensitivity that was lower than that of KOH microscopic examination carried out by experienced clinical practitioners (38).We have developed a sensitive immunochromatography test (ICT), the CandiVagi assay (SR2B, Avrille, France), for the rapid diagnosis of VVC using an immunoglobulin M (IgM) monoclonal antibody (MAb) directed against the Candida mannan (18, 40). Here, we present the results of a preliminary evaluation of this test and a comparison of the results obtained by ICT with those obtained by conventional microscopy and culture. Specific attention was focused on the ability of ICT to discriminate between Candida carriage and Candida infection and its specificity for women with bacterial/trichomonal vaginitis.     

Patterns of Recovery from Severe Mental Illness: A Pilot Study of Outcomes

Abstract  

We performed a pilot study examining the patterns of recovery from severe mental illness in a model integrated service delivery system using measures from the Milestones of Recovery Scale (MORS), a valid and reliable measure of recovery outcomes which ranges from 1 to 8 (8 levels). For purposes of presentation, we constructed an aggregate MORS (6 levels) where the levels are described as follows: (1) extreme risk; (2) unengaged, poorly self-coordinating; (3) engaged, poorly self-coordinating; (4) coping and rehabilitating; (5) early recovery, and (6) self reliant. We analyzed MORS data on individuals followed over time from The Village in Long Beach, California (658 observations). Using Markov Chains, we estimated origin-destination transition probabilities, simulating recovery outcomes for 100 months. Our models suggest that after 12 months only 8% of “extreme risk” clients remain such. Over 40% have moved to “engaged, poorly self-coordinating.” After 2 years, almost half of the initial “extreme Risk” clients are “coping/rehabilitating”, “early recovery” or “Self reliant.” Most gains occur within 2 years.