Routine Care Settings Research Articles

Effectiveness of vortioxetine in patients with major depressive disorder and comorbid Alzheimer's disease in routine clinical practice: An analysis of a post-marketing surveillance study in South Korea.

Vortioxetine has demonstrated procognitive effects in patients with major depressive disorder (MDD). We assessed the effectiveness and safety of vortioxetine in a cohort of patients with MDD and comorbid Alzheimer's disease participating in a large post-marketing surveillance study in South Korea. Subgroup analysis of a 6-month, prospective, multicenter, non-interventional cohort study in outpatients with MDD with a pre-baseline diagnosis of Alzheimer's disease receiving vortioxetine in routine care settings (n = 207). Patients were assessed at baseline and after 8 weeks; a subset of patients was also assessed after 24 weeks. Depression severity was assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS) and Clinical Global Impression (CGI) scale, cognitive symptoms using the Perceived Deficits Questionnaire-Depression, Korean version (PDQ-K), and cognitive performance using the Digit Symbol Substitution Test (DSST). Most patients were receiving a mean daily vortioxetine dose of 5 mg/day (174/190 patients; 91.6%). After 24 weeks of vortioxetine treatment, 71.4% of patients (40/56) had experienced overall clinical improvement (i.e., CGI-Improvement score ≤3) and 51.9% (28/54) had achieved remission from depressive symptoms (i.e., MADRS total score ≤10 points). Respective mean changes in MADRS, PDQ-K, and DSST total scores from baseline to week 24 were -11.5 (p < 0.0001), -5.1 (p = 0.03), and +3.8 points (p = 0.0524). Adverse events were reported by 27 patients (13.0%) and were mostly mild (89.2%). Patients with MDD and comorbid Alzheimer's disease receiving vortioxetine in routine care settings in South Korea demonstrated clinically meaningful improvements in depressive symptoms, cognitive symptoms, and objective cognitive performance over the 6-month treatment period. Treatment with vortioxetine was well tolerated in this patient cohort, with reported adverse events consistent with the established tolerability profile of vortioxetine.

Widespread Distribution of Xylazine Detected Throughout the United States in Healthcare Patient Samples.

Xylazine is a tranquilizer commonly added into the illicit drug supply and a likely contributor to overdoses because it does not respond to naloxone reversal. The objective of this study was to perform a retrospective data analysis on xylazine-positive samples collected from patients in various outpatient healthcare settings to illustrate geographic distribution and common copositive substances, which may also contribute to risk of adverse events. Samples for which providers ordered testing for xylazine were subjected to enzymatic hydrolysis, extracted, and analyzed using liquid chromatography-tandem mass spectrometry. Retrospective analysis was performed on xylazine-positive samples collected from April 2021 to March 2022, to include geographic location and copositive substances. Xylazine was identified in 413 of 59,498 samples from adults aged 20-73 years and originated from 25 of the 39 states where xylazine testing was ordered. The most common routine substances detected with xylazine were fentanyl, buprenorphine, naloxone, cocaine, d -methamphetamine, and delta-9-tetrahydrocannabinol. The most common designer drugs detected included fentanyl analogs, isotonitazene, and designer benzodiazepines. Xylazine is geographically spread throughout the United States, indicative of a wide incorporation into the illicit drug supply. These findings differ from previous studies in that these samples originated from healthcare providers in routine care settings, where other reports typically involve overdose deaths. This analysis illustrates that routine testing for xylazine in outpatient settings can afford providers the opportunity to educate individuals and adjust harm reduction measures to potentially mitigate overdose risk.

Finerenone in chronic kidney disease and type 2 diabetes: the known and the unknown

The novel nonsteroidal mineralocorticoid receptor antagonist finerenone has been shown to reduce the risk of kidney and cardiovascular outcomes in patients with type 2 diabetes and chronic kidney disease. In this issue of Kidney International, Bakris etal. present new data on the kidney efficacy of finerenone across subgroups of estimated glomerular filtration rate and urinary albumin-to-creatinine ratio, as well as safety data. We attempt to place these results in context by discussing the benefits and risks of finerenone, as well as the generalizability of the study findings to routine care settings.

Research-Practice Partnership to Develop and Implement Routine Mental Health Symptom Tracking Tool Among Older Adults During COVID-19

Older adults are disproportionally impacted by the COVID-19 pandemic, causing a mental health crisis in late life, due to physical restrictions (e.g., quarantine), limited access to services, and lower literacy and access to technology. Despite established benefits, systematic screening of mental health needs of older adults in community and routine care settings is limited and presents multiple challenges. Cross-disciplinary collaborations are essential for identification and evaluation of mental health needs and service delivery. Using a research-practice partnership model, we developed and implemented a routine mental health needs identification and tracking tool at a community-based social services organization. Repeated screenings were conducted remotely over 5 months and included depression, anxiety, perceived loneliness, social support, and related domains such as sleep quality, resilience, and trauma symptoms linked to COVID-19. We examined symptomatic distress levels and associations between different domains of functioning. Our project describes the process of establishing a research-practice partnership during the COVID-19 pandemic. We collected 292 screenings from 124 individuals; clients were mildly to moderately depressed and anxious, reporting large amounts of time alone and moderate levels of loneliness. Those reporting higher depressive symptoms reported higher anxiety symptoms, poorer sleep quality, lower quality of life, lower capacity to adapt to challenging situations, and greater trauma symptoms due to COVID-19. Our routine screening tool can serve as a blueprint for case management agencies and senior centers nationwide, beyond the pressing mental health crisis due to COVID-19, to continue identifying needs as they emerge in the community.

Pragmatic Effectiveness of Face-to-Face Cognitive-Behavioral Therapy for Family Caregivers of People with Dementia

ABSTRACT Objectives The objective was to investigate the pragmatic effectiveness of face-to-face cognitive-behavioral therapy (F2F-CBT) for family caregivers of people with dementia (PwD) implemented in a routine care setting relative to usual care in a quasi-experimental study. Methods Participants indicating that attendance of F2F-CBT was possible were assigned to F2F-CBT (n = 49). F2F-CBT consisted of 12 sessions over 6 months. Effects were evaluated at posttest and 6-month follow-up on a variety of outcomes relative to usual care (CG; n = 134). Results At posttest, F2F-CBT yielded significantly fewer symptoms of depression (d = 0.37), better emotional well-being (d = 0.64), and better coping with the care situation (d = 0.52) than CG. At 6-month follow-up, the effect on emotional well-being was retained (d = 0.44) and social relationships were rated significantly better in F2F-CBT than CG (d = 0.34). Conclusions F2F-CBT proved to be effective in supporting family caregivers of PwD. However, only relatively few caregivers were able to regularly attend face-to-face sessions. Clinical Implications CBT seems particularly suitable for supporting family caregivers of PwD in coping with the complex psychological burden. Delivery via telephone or internet could be a necessary alternative to F2F-CBT for reducing barriers to participation.

Vertical HIV transmission within 18 months post partum among women on lifelong antiretroviral therapy for HIV in Dar es Salaam, Tanzania: a prospective cohort study

The UNAIDS estimate of vertical HIV transmission in Tanzania is high (11%), despite 84% uptake of antiretroviral therapy (ART) among pregnant women with HIV. We aimed to evaluate vertical transmission and its determinants by 18 months post partum among women on lifelong ART in routine health-care settings in Tanzania. We conducted a prospective cohort study in 226 health facitilies across Dar-es-Salaam, Tanzania. Eligible participants were pregnant women of any age with HIV, and later their infants, who enrolled in routine health-care services for the prevention of vertical transmission. We prospectively followed up mother-infant pairs at routine monthly visits until 18 months post partum and extracted data from the care and treatment clinic (CTC2) database, a national electronic database that stores patient-level HIV care and treatment clinic data. The primary outcome was time from birth to HIV diagnosis, defined as a positive infant HIV DNA PCR or antibody test from age 18 months. We used the Kaplan-Meier method to estimate cumulative risk of vertical transmission by 18 months post partum and Cox proportional hazards regression with shared frailties to account for potential clustering in health facilities to evaluate predictors of transmission. Between Jan 1, 2015, and Dec 31, 2017, 22 930 pregnant women with HIV (median age 30 years, IQR 25-34) enrolled on a care programme. After excluding 9140 (39·9%) women and 539 (2·4%) infants with missing outcome data, 13 251 (59·0%) mother-infant pairs were analysed, of whom 6072 (45·8%) women were already on ART before pregnancy. By 18 months post partum, 159 (1·2%) of 13 251 infants were diagnosed with HIV, equivalent to a risk of vertical transmission of 1·4% (95% CI 1·2-1·6). In the complete case analysis, the rates of vertical transmission were higher among women who enrolled in the third trimester of pregnancy than among those who enrolled in the first trimester (adjusted hazard ratio 3·01, 95% CI 1·59-5·70; p=0·0003), among women with advanced HIV disease than among those with early-stage disease (1·89, 1·22-2·93; p=0·0046), and among women who were on a second-line ART regimen than among those on a first-line regimen (3·58, 1·08-11·82; p=0·037). By contrast, the rate of vertical transmission was lower among women who were already on ART at enrolment than among those starting ART at enrolment (0·39, 0·25-0·60; p<0·0001) as well as among women in high-volume clinics than among those in low-volume clinics (0·46 (0·24-0·90; p<0·0097). Provision of ART for life (WHO's option B+ recommendation) has reduced the risk of vertical transmission to less than 2% among pregnant women with HIV in routine care settings in urban Tanzania. There is still a need to improve timely HIV diagnosis and ART uptake, and to optimise follow-up for the prevention of vertical transmission and the uptake of infant HIV testing. Swedish International Development Cooperation Agency.

Protocol, rationale and design of the PHOLLOW cross-sectional and retrospective chart review study to assess the prevalence and characterize the patient profile, clinical features and disease burden of type-2 low severe asthma in routine care settings in Greece

1. GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017;390(10100):1211-1259. doi:10.1016/S0140-6736(17)32154-2 CrossRef Google Scholar

Application of 'Readiness for Change' concept within implementation of evidence-based mental health interventions globally: protocol for a scoping review.

Concerning the growing burden of mental illnesses globally, there has been an increased investment into the implementation of evidence-based mental health interventions (EBmhIs) in routine care settings. However, the uptake and implementation of these EBmhIs has faced challenges in the real-world context. Among the many barriers and facilitators of implementation of EBmhIs identified by implementation science frameworks, evidence on the role of readiness for change (RFC) remains sparse. RFC constitutes the willingness and perceived capacity of stakeholders across an organization to implement a new practice. Theoretically, RFC has been defined at organizational, group, and individual levels, however, its conceptualization and operationalization across all these levels have differed in studies on the implementation of EBmhIs. By conducting a scoping review, we aim to examine the literature on RFC within the implementation of EBmhIs. This scoping review will be conducted following the PRISMA-ScR guidelines. Iterative review stages will include a systematic and comprehensive search through four electronic databases (PubMed, Web of Science, Embase, and PsycINFO), selecting studies, charting data, and synthesizing the results. English-language studies meeting the inclusion criteria will be screened independently by two reviewers. This review will synthesize knowledge on the conceptualization of RFC across organizational, group, and individual levels within the implementation of EBmhIs. In addition, it will identify how RFC has been measured in these studies and summarize the reported evidence on its impact on the implementation of EBmhIs. This review will assist mental health researchers, implementation scientists, and mental health care providers to gain a better understanding of the state of research on RFC within the implementation of EBmhIs. The final protocol was registered with the Open Science Framework on October 21, 2022 ( https://osf.io/rs5n7).

Telehealth-Based Health Coaching Produces Significant Weight Loss over 12 Months in a Usual Care Setting

Background: Telehealth-based health coaching in a usual care setting has yet to be examined. The purpose of this study was to incorporate the inHealth Lifestyle Therapeutics, Inc.’s Telehealth Enabled Approach to Multidisciplinary Care (TEAM) method within a real-world routine clinical care setting to reduce body weight in obese participants. Materials and Methods: n = 70 participants were recruited for this intervention (Age: 58.1 ± 14.6yrs, BMI: 35.5 ± 7.8 kg/m2, 32 males and 38 females). All participants self-selected participation in either the virtual health coaching (VHC) group or usual care (UC) group. VHC participants met with a medical doctor monthly and a certified health coach weekly for the first 12 weeks of the study, bi-weekly for the following 12 weeks, and monthly for the remaining 6 months. Data were analyzed using a two-sample student’s t-test to assess any changes from baseline for both VHC and UC groups. Results: A significant difference for weight-loss between VHC and UC groups (8.24 ± 9.8 vs. 0.16 ± 10.6 kg, respectively, p &lt; 0.05) was observed. In addition, there was a significant change in the mean percentage of body weight loss (6.5 ± 0.1% vs. 0.53 ± 1.45%, respectively, p &lt; 0.05) between groups. Conclusions: Incorporating innovative deliveries that are scalable, such as telehealth-based interventions, may help stem the tide of patient obesity related care. Furthermore, using a TEAM method in a usual care setting may be effective for inducing sustained weight loss at 12 months.

Developing and Validating a Tool to Assess Telemedicine Acceptance Among Physicians During Pandemic Using a Technology Acceptance Model.

Background: The World health organization declared the coronavirus outbreak a global pandemic on March 11, 2020. Telemedicine was one of the effective tools that were implemented during this pandemic. Most Lebanese physicians have been using telemedicine to perform virtual medical services during the COVID-19 pandemic. Therefore, it is important to assess the physicians' acceptability of telemedicine and willingness to use it in routine health care settings. Objective: We developed and validated a tool based on technology acceptance model (TAM) to explore the acceptance of telemedicine use during the pandemic among Lebanese physicians. Theoretical Background: Telemedicine Acceptance Model during Pandemic (TeAM) was developed based on TAM. The model was developed considering the associations between constructs affecting the physicians' attitudes about telemedicine use. TeAM is a tool assessing telemedicine acceptance based on the TAM. It has additional constructs tackling the perceived risks of telemedicine use, the perceived need for policies, the perceived need for training, and the perceived usefulness of telemedicine during a pandemic. Methods: This cross-sectional study was conducted online through an email-based questionnaire sent to physicians enrolled in the Lebanese Order of Physicians. Results: Three hundred ninety physicians (n = 390) completed the survey. The tool was structured to test 10 hypotheses, out of which 9 were supported. The Cronbach's alpha score of each construct ranged between 0.745 and 0.905, all greater than 0.7 indicating an acceptable to excellent internal consistency. Conclusion: This study was able to validate TeAM as a reliable tool that can assess the acceptance of telemedicine among physicians. Accordingly, several determinants influencing this acceptance were identified. Practice implications include hospitals, primary health care centers, and national health care systems willing to adopt telemedicine can use TeAM to assess the physicians' willingness to accept the implementation of telemedicine in their practice.

The Effectiveness and Tolerability of Glycopyrronium for Patients with Chronic Obstructive Pulmonary Disease in a Clinical Setting: GLARE-Taiwan.

Glycopyrronium (GLY) is a pharmacological maintenance treatment for chronic obstructive pulmonary disease (COPD). However, its effectiveness and tolerability for COPD patients in routine clinical practice have not been well-investigated. This study aimed to assess the effectiveness of GLY on health-related quality of life and its safety in patients with COPD in a routine clinical care setting. This multi-center, prospective, six-month observational study recruited patients diagnosed with COPD and treated with GLY at three medical centers in central Taiwan. The full analysis set (n = 102) had a significant improvement in the Clinical COPD Questionnaire total (mean ± SD = −0.39 ± 0.90, p = 0.002), symptoms (mean ± SD = −0.61 ± 0.90, p < 0.001) and mental state scores (mean ± SD = −0.54 ± 1.72, p = 0.021) but not the functional state score (mean ± SD = −0.10 ± 1.15, p = 0.529). During the observational period, 58 patients (52.73%) experienced adverse events; only one adverse event (dizziness) was suspected to be related to the study drug. Three patients (2.73%) discontinued the study and GLY treatment because of an adverse event. One patient (0.91%) died during the study period because of a cerebral infarction, which was judged to be not associated with GLY treatment. In conclusion, GLY could be effective in improving the health status and is safe for patients with COPD in a real-life setting.

Lack of Harmonized Adherence Criteria in Allergen Immunotherapy Prevents Comparison of Dosing and Application Strategies: A Scoping Review

Allergen immunotherapy (AIT) involves the application of increasing doses of allergen extract (as oral, sublingual, or subcutaneous immunotherapy) until immunologic tolerance is reached. Successful AIT relies on the consistent administration of allergen extract; therefore, adherence to these treatments is vital for compelling long-term results. Our review discusses the current terminology from adherence research in general, summarizes 25 current studies on adherence research in AIT in a scoping literature review, and delineates recommendations for tools and parameters for adherence research, aiming to improve outcomes in AIT. Almost every adherence study in AIT published to date used different tools, parameters, and data sources for measuring adherence and persistence rates. Unfortunately, an easily accessible, objective parameter or biomarker for monitoring treatment adherence and success has not yet been established for AIT. This situation calls for the development of an international core outcomes set for AIT that defines what is exactly meant by AIT adherence and how AIT adherence should be consistently measured. Therefore, we exemplarily present results and conclusions from adherence research in chronic diseases other than allergology. We aim to facilitate the development of advanced methods, considering the challenging disease specificities of these parameters in a routine care setting of AIT.

Virtual Reality during Intrathecal Pump Refills in Children: A Case Series.

Virtual reality has proven to be an effective approach to decrease pain in acute settings, both in adults and children. The aim of this study is to evaluate whether virtual reality (VR) could reduce pain during an intrathecal pump refill procedure in children receiving intrathecal drug delivery, compared to a standard refill procedure. This is a three-arm crossover randomized controlled trial, evaluating the effect of VR on pain in children with cerebral palsy undergoing an intrathecal pump refill compared to a standard refill and a refill with distraction (watching a video). Pain was evaluated using the Wong–Baker Faces Scale. Secondary outcomes were procedural pain, fear, state anxiety, the incidence of adverse events and satisfaction. Six children participated in this study, whereby all children underwent the three conditions. Five children indicated an equal of lower pain score during VR, compared to a standard refill. This finding of an equal or lower pain intensity score for the VR condition compared to the control condition was also revealed by the ratings of the parents, physician and the researcher. The influence of VR on anxiety and fear seem to be in line with the influence of watching a video. In terms of satisfaction, all children and parents agreed with the statement that they would like to use VR again for a next refill. Due to the lack of adverse events, the high degree of satisfaction of children with VR and the decreased pain levels after a refill with VR, physicians may aim to explore the implementation of VR during intrathecal pump refill procedures in children in a daily clinical routine care setting.

Precision Implementation: An Approach to Mechanism Testing in Implementation Research.

Advancing mechanism-focused research in implementation science is a priority given its potential to improve tailoring and efficiency of implementation strategies. Experimental therapeutics, or experimental medicine, offers an approach for mechanism testing that has been promoted by the NIH Science of Behavior Change and endorsed by the National Institute for Mental Health. This approach has been applied across the translational spectrum - with initial applications to biological research and more recent applications to psychosocial treatment development research. We describe further advancement of experimental therapeutics along the translational spectrum and describe how it is ideally suited to inform precision experimental tests of implementation strategy mechanisms, which we term precision implementation. Such an approach to mechanism testing will allow for identification of causal dose-response relationships between implementation strategies, presumed mechanisms, and implementation outcomes. We discuss the tension between the scientific rigor required to conduct mechanism-focused research using experimental therapeutics and the "real world" conditions in which implementation research takes place. We provide a series of example studies that show "beginning to end" application of this framework in research focused on provider implementation of an evidence-based intervention in routine clinical care settings.

P449 Semi-quantitative cryptococcal antigen rapid test (CryptoPS, Biosynex®) for cryptococcal meningitis in patients living with HIV in Sub-Saharan Africa: prospective multicenter diagnostic accuracy study (DREAMM)

Poster session 3, September 23, 2022, 12:30 PM - 1:30 PMBackgroundCryptococcal meningitis (CM) remains a leading cause of HIV-related meningoencephalitis in African low- and middle-income countries (LMICs), causing 15%-20% of HIV-related deaths. Rapid Diagnostic Tests (RDTs) are powerful tools and key to speeding-up the diagnosis at the bedside, allowing for rapid and targeted treatment, especially in LMICs. For the past 10 years, Cryptococcal Antigen (CrAg) RDTs have a major role in CM management.Driving Reduced AIDS Meningo-Encephalitis Mortality (DREAMM) was a multicenter implementation science study and a capacity-building project to reduce the mortality of HIV-related central nervous system infections (CNS). One of the main DREAMM approaches was to improve the diagnosis of CNS infections at the bedside and in parallel in local laboratories. Within DREAMM, HIV-infected, adult people living with HIV (>18 years old) with suspected CNS infections were recruited in five hospital sites in Cameroon, Malawi, and Tanzania.ObjectivesOur objective was to evaluate the implementation of CrAg CryptoPS (Biosynex, Illkirch Graffenstaden, France), a new semi-quantitative RDT, in routine care settings in Sub-Saharan Africa.MethodsAll CrAg CryptoPS performed were compared to the reference CrAg lateral flow assay (Immy®). The evaluation was done by the local research teams in four DREAMM laboratories sites. CrAg CryptoPS's implementation was evaluated in 301 plasma samples and 258 cerebrospinal fluid (CSF) samples from 320 participants (patients diagnosed with cerebral toxoplasmosis did not have a lumbar puncture). In this analysis, the results will be considered in a binary way (positive/negative).ResultsBetween January 2018 and March 2021, 356 participants were prospectively enrolled with suspected HIV-related CNS infections, including CM, tuberculous meningitis, cerebral toxoplasmosis, and bacterial meningitis cases. Cryptococcal meningitis was the leading cause of CNS infections in Malawi and Tanzania with 66.3% (53/80) and 59.6% (59/99) cases respectively, and the second cause in Cameroon with 40.0% (39/90) cases after cerebral toxoplasmosis.In plasma, CryptoPS's sensitivity was 99.23% (95% CI, 0.98-1.01) and specificity was 94.15% (95% CI, 0.91-0.98); positive and negative predictive values were 92.8% and 99.4%, respectively. In CSF, the sensitivity and specificity of CryptoPS were 100% (95% CI, 0.0-0.0), and 99.26% (95% CI, 0.98-1.01), respectively; positive and negative predictive values were both 100%. A low number of false-positives were observed (<4% in plasma and <0.5% in CSF).ConclusionCryptoPS was evaluated in a context of hospitalized patients within a project including all causes of HIV-related CNS infection, not only CM. The sensitivity and specificity of CryptoPS calculated in these preliminary results are promising. Semi-quantitative CryptoPS has the potential to be used to tailor antifungal therapy but further optimizations need to be done prior to large-scale implementation in African LMICs. In addition, future work to determine CrAg antigen titres is planned, in the perspective to optimize treatment of CrAg positive cases who decline lumbar puncture.

The future of CBT and evidence-based psychotherapies is promising.

The future of CBT and evidence-based psychotherapies is promising.

How Flexible are Treatments for Youth Internalizing Disorders? Examining Modification Guidelines Included across Supported Treatments

ABSTRACT Objective Treatment protocols for youth-internalizing disorders have been developed, however these protocols have yielded mixed findings in routine care settings. Despite increased recognition of the importance of flexibility when delivering evidence-based treatments (EBTs), little is known about the extent to which protocols offer guidance to providers in flexible EBT implementation. The current study examined the extent to which supported EBTs for youth internalizing disorders explicitly incorporate guidance for treatment modification. Methods Supported treatment protocols for youth internalizing disorders were identified (N = 44), from which 4,021 modification guidelines were extracted and coded using a structured coding system to classify modification strategies (i.e., the forms that recommended modifications take), and associated tailoring factors (i.e., the rationale for which modifications are recommended). Results Across all EBTs, modification guidelines were quite common, with the average protocol including almost 91 text passages providing guidance for modification. The majority of modification guidelines functionally increase session or treatment length by recommending the addition or repetition of material, whereas less than 5% of modification guidelines provided strategies for condensing or streamlining care. Strikingly, less than 2% of modification guidelines in EBT protocols address patient cultural factors, and rarely address provider or setting issues that can challenge standard implementation. Conclusions Findings highlight critical gaps in the available guidance to modify EBTs for youth internalizing disorders, and suggest EBT protocols may not be optimally poised to flexibly address the broad diversity of children and adolescents across varied settings in need of mental health care.

Effectiveness of Vortioxetine in Patients with Major Depressive Disorder in Real-World Clinical Practice in Italy: Results from the RELIEVE Study.

PurposeVortioxetine has demonstrated efficacy in randomized controlled trials and is approved for the treatment of major depressive disorder (MDD); however, data are limited concerning its effectiveness when used in routine clinical care. The Real-Life Effectiveness of Vortioxetine in Depression (RELIEVE) study aimed to assess the effectiveness and tolerability of vortioxetine for the treatment of MDD in routine clinical practice in Canada, France, Italy, and the USA. This paper presents findings for the patient cohort in Italy.Patients and MethodsRELIEVE was a 6-month, international, observational, prospective cohort study in outpatients initiating vortioxetine treatment for MDD in routine care settings at their physician’s discretion (NCT03555136). Patient functioning was assessed using the Sheehan Disability Scale (SDS). Secondary outcomes included depression severity (9-item Patient Health Questionnaire [PHQ-9]), cognitive symptoms (5-item Perceived Deficits Questionnaire-Depression [PDQ-D-5]), and quality of life (EuroQol 5-Dimensions 5-Levels questionnaire [EQ-5D-5L]). Changes from baseline to month 6 were assessed using mixed models for repeated measures, adjusted for relevant confounders.ResultsData are available for 231 patients enrolled in Italy (mean age, 55.5 years; 27% >65 years). Overall, 69% of patients reported at least one comorbidity, 55% were overweight/obese, and 47% had current anxiety symptoms. Adjusted least-squares mean (standard error) change in SDS score from baseline to week 24 was −6.6 (0.6) points (P < 0.001). Respective changes in PHQ-9, PDQ-D-5, and EQ-5D-5L scores were −5.9 (0.5), −3.6 (0.4), and +0.13 (0.01) points (all P < 0.0001). Adverse events were reported by 29 patients (13%), most commonly nausea (n = 14, 6%). Eleven patients (5%) discontinued treatment due to adverse events.ConclusionClinically relevant and sustained improvements in overall functioning, symptoms of depression, cognitive symptoms, and health-related quality of life were observed in patients with MDD treated with vortioxetine over a period of 6 months in routine care in Italy, including a high proportion of elderly patients.

Effectiveness of Vortioxetine in Patients with Major Depressive Disorder in Real-World Clinical Practice: French Cohort Results from the Global RELIEVE Study.

AimFunctional recovery is an important treatment goal in patients with major depressive disorder (MDD). The Real-Life Effectiveness of Vortioxetine in Depression (RELIEVE) study assessed the effectiveness of vortioxetine in patients with MDD receiving treatment in routine clinical care settings in France, Italy, Canada, and the United States. This paper presents the study data for the cohort enrolled in France.MethodsRELIEVE was a 6-month, international, observational, prospective cohort study in outpatients initiating vortioxetine treatment for MDD at their physician’s discretion (NCT03555136). Patients were assessed at routine clinic visits at study entry (baseline) and after 12 and 24 weeks of vortioxetine treatment. The primary study outcome was patient functioning, assessed by the Sheehan Disability Scale (SDS). Secondary outcomes included depression severity (assessed by the Patient Health Questionnaire [PHQ-9]), cognitive symptoms (assessed by the Perceived Deficits Questionnaire-Depression [PDQ-D-5]), and cognitive performance (Digit Symbol Substitution Test [DSST]). Changes from baseline to week 24 were assessed using mixed models for repeated measures, adjusted for relevant confounders. Adverse events spontaneously reported by the patient or observed by the investigator were recorded.ResultsData are available for 184 patients in France (mean age, 50.2 years; 65.2% female). Overall, 67.9% of patients had at least one comorbidity and 46.2% reported current anxiety symptoms at baseline. Adjusted least-squares mean (standard error) change in SDS score from baseline to week 24 was −10.9 (0.6) points (P < 0.001). Respective changes for PHQ-9, PDQ-D-5 and DSST scores were −9.3 (0.5), −6.1 (0.4), and +6.9 (1.0) points (all P < 0.0001). Adverse events were reported by 29 patients (15.8%), most commonly nausea (11 patients, 6.0%).ConclusionClinically relevant and sustained improvements in overall functioning, depressive symptoms, cognitive symptoms, and cognitive performance were observed in patients with MDD treated with vortioxetine for 6 months in routine clinical practice settings in France.

Clinical, endocrine and genetic spectrums of mucopolysaccharidoses type VI in Duhok city, Kurdistan region, Iraq

Mucopolysaccharidoses type VI is a rare disorder and establishing the diagnosis requires assays that are unavailable in a routine care setting. There is an increased risk of considerable diagnostic delay and missing patients due to incorrect diagnosis. The present study was conducted to determine the socio-demographic characteristics, clinical manifestations, and anthropometric parameters of patients with MPS type VI. Patients' enzyme levels and genetic profiles were also examined. The present study included a total of 16 patients who had been diagnosed as MPS type VI and were referred to Hivi Pediatric Hospital in Duhok, Kurdistan Region, Iraq, till the time period of March 2022. Diagnoses were made in all the patients by analyzing the enzyme level. Moreover, a genetic study was performed to confirm the diagnosis. From each of the patients, a blood sample was taken to determine the hematological parameters. Among the study participants, 9 were males and 7 were females. The mean age of the patients was 6.81±4.99 years and the age at diagnosis was 21.13±15.19 months. All of them presented with a course facial features, 75% had short stature, 87.5% had corneal clouding, 12.5% had glaucoma, 68.75% had poor vision, 18.75% of them had optic nerve disease, 56.25% had otitis media, 56.25% had poor hearing, 68.75% had a history of recurrent sinusitis, 50% had an enlarged tongue, and 75% had abnormal teeth. Approximately 56.25% of the patients presented with sleep apnea, 37.5% had obstructive and restrictive airway disease, none of the patients had cardiac arrhythmia, 37.5% had cardiomyopathy, 31.25% had abdominal hepatosplenomegaly, 81.25% had skeletal abnormalities, all of the patients had normal intelligence, 9 (56.25%) had a past medical history of other systemic illness and 7 (43.75%) had a past history of surgery. Out of the total number of patients, 13 patients had c.962T>C (p.(Leu321Pro)) mutation, one patient had c.585T>A (p.(ASP195Glu)) mutation, one patient had c.[585T>A];[753C>G] (Asp195 Glu];[Tyr251 Ter]), and one patient had c.{288C>A];[962T>C] (p.[Ser96Arg];[Leu321Pro]) mutations. Due to the rarity in prevalence, early detection of the said disorder is critical; early treatment may result in improved outcomes, which may have potential significance for newborn screening.