Clinical Outcomes In People Research Articles

Thrombus aspiration in people living with HIV- a night mare for interventionist

Abstract Background Cardiovascular disease, particularly atherosclerosis, and its complications are a growing cause of morbidity and mortality among individuals living with human immunodeficiency virus (HIV) in the post-antiretroviral therapy era. The role of thrombus aspiration combined with primary percutaneous coronary intervention (PCI) in ST-segment elevation myocardial infarction (STEMI) within this population remains contentious. While PCI is the preferred strategy for immediate revascularization in acute STEMI, challenges persist, with about 30% of patients experiencing persistent chest pain and ST-segment elevation despite achieving TIMI III flow in the culprit vessel. Methods We conducted a prospective observational study spanning from January 2015 to September 2023, involving ten consecutive HIV-infected patients presenting with STEMI to our acute coronary care unit. The study encompassed an analysis of baseline clinical characteristics, response to fibrinolytic therapy, angiographic findings, thrombus aspiration using the Export Aspiration Catheter, and the outcomes of percutaneous coronary intervention (PCI). Patients were closely monitored for in-hospital outcomes and followed up for five years, during which they received adjuvant highly active antiretroviral therapy (HAART). Results The mean age of the patients was 46 years, lower than their uninfected counterparts. Most patients presented with a lower Killip class, indicating favorable outcomes. CD4 count distribution showed variability, with ten patients undergoing rescue angioplasty with thrombus aspiration using the Export Catheter. The cohort was followed for five years, receiving consistent HAART therapy. Conclusion HIV-associated atherosclerosis presents a considerable health burden, characterized by distinctive non-calcified and inflammatory plaques vulnerable to rupture. Thrombus aspiration during PCI emerged as a valuable strategy, reducing thrombotic burden and contributing to improved clinical outcomes in people living with HIV.

Validation of serum non-invasive tests of liver fibrosis as prognostic markers of clinical outcomes in people with fatty liver disease in Australia.

The validity of non-invasive tests (NITs) of liver fibrosis for the prediction of liver and mortality outcomes in an Australian cohort is unknown. We aimed to verify the utility of available NITs to predict overall and cause-specific mortality and major adverse liver outcome (MALO). This was an analysis from the Crossroads 1 clinic sub-study of a randomly sampled adult cohort from regional Australia between 2001 and 2003. Baseline variables included demographic details, anthropometry, health and lifestyle data, and laboratory tests. Non-alcoholic fatty liver disease (NAFLD) and metabolic-(dysfunction) associated fatty liver disease (MAFLD) were defined by fatty liver index≥60 and other accepted criteria. Outcomes were defined by the International Statistical Classification of Diseases and Related Health Problems 10th Revision codes for linked hospitalization and death registry data. Available serum-based NITs were analyzed as predictors of overall, cardiovascular disease-related, and cancer-related mortality and MALO in those with fatty liver disease (FLD). In total, 1324 and 1444 participants were included for NAFLD and MAFLD analysis (prevalence 35.4% and 40.7%, respectively). There were 298 deaths (89 cardiovascular disease-related and 98 cancer-related) and 24 MALO over a median 19.7years of follow-up time. In both forms of FLD, fibrosis-4 index, Steatosis-Associated Fibrosis Estimator score, and Forns fibrosis score consistently had the highest area under the receiver operating characteristic curve (AUROC) for overall and cause-specific mortality, with AUROC>0.70 for each outcome. However, all had poor discriminatory ability for determining MALO in each FLD. Several liver fibrosis NITs perform similarly reasonably well in predicting the risk of mortality outcomes in those with FLD but are poorly discriminatory for MALO prediction.

Combination of the chemokine receptor type 2 (CCR2) antagonist DMX-200 and candesartan for COVID-19: a randomised controlled trial

ObjectiveTo determine whether a chemokine receptor type 2 antagonist, DMX-200 (repagermanium), in combination with an angiotensin receptor blocker, candesartan, improves clinical outcomes in people with COVID-19.DesignProspective, multicentre, double-blind, placebo-controlled trial.SettingTen...

Long-term impact of ivacaftor on mortality rate and health outcomes in people with cystic fibrosis

BackgroundIvacaftor (IVA) has been shown to improve lung function and other clinical outcomes in people with cystic fibrosis (CF). A decade of real-world IVA availability has enabled the examination of...

Comorbidity and Disease Activity in Multiple Sclerosis

Multiple studies suggest that comorbidity worsens clinically relevant outcomes in multiple sclerosis (MS), including the severity of disability at diagnosis and rate of disability worsening after diagnosis. However, less is known regarding the association of comorbidity with measures of disease activity, such as relapse rate and magnetic resonance imaging lesion accrual, which are relevant to clinicians and clinical trialists. To evaluate the association of comorbidities with disease activity in clinical trials of disease-modifying therapies (DMTs) in populations with MS. A 2-stage meta-analytic approach was used in this cohort study of individual participant data from phase 3 clinical trials of MS DMTs that had 2 years of follow-up and were conducted from November 2001 to March 2018. Data were analyzed from February 2023 to June 2024. Comorbidity burden and individual comorbidities present at trial enrollment, including hypertension; hyperlipidemia; functional cardiovascular disease, ischemic heart, cerebrovascular, and peripheral vascular disease; diabetes; autoimmune thyroid and miscellaneous autoimmune conditions; migraine; lung and skin conditions; depression; anxiety; and other psychiatric disorders. The main outcome was evidence of disease activity (EDA) over 2 years of follow-up, defined as confirmed relapse activity, disability worsening, or any new lesions on magnetic resonance imaging. A total of 16 794 participants with MS were included from 17 clinical trials (67.2% female). Over the 2-year follow-up, 61.0% (95% CI, 56.2%-66.3%; I2 = 97.9%) of the pooled trials had EDA. After adjusting for multiple factors, the presence of 3 or more comorbidities was associated with an increased hazard of EDA (adjusted hazard ratio [AHR], 1.14; 95% CI, 1.02-1.28) compared with no comorbidity. Presence of 2 or more cardiometabolic conditions was also associated with an increased hazard of EDA (AHR, 1.21; 95% CI, 1.08-1.37) compared with no cardiometabolic comorbidity. Presence of 1 psychiatric disorder was associated with an increased hazard of EDA (AHR, 1.07; 95% CI, 1.02-1.14). In this study, a higher burden of comorbidity was associated with worse clinical outcomes in people with MS, although comorbidity could potentially be a partial mediator of other negative prognostic factors. Our findings suggest a substantial adverse association of the comorbidities investigated with MS disease activity and that prevention and management of comorbidities should be a pressing concern in clinical practice.

The association between HIV-1 Tat and Vif amino acid sequence variation, inflammation and Trp-Kyn metabolism: an exploratory investigation

BackgroundHIV-1 has well-established mechanisms to disrupt essential pathways in people with HIV, such as inflammation and metabolism. Moreover, diversity of the amino acid sequences in fundamental HIV-1 proteins including Tat and Vif, have been linked to dysregulating these pathways, and subsequently influencing clinical outcomes in people with HIV. However, the relationship between Tat and Vif amino acid sequence variation and specific immune markers and metabolites of the tryptophan-kynurenine (Trp-Kyn) pathway remains unclear. Therefore, this study aimed to investigate the relationship between Tat/Vif amino acid sequence diversity and Trp-Kyn metabolites (quinolinic acid (QUIN), Trp, kynurenic acid (KA), Kyn and Trp/Kyn ratio), as well as specific immune markers (sCD163, suPAR, IL-6, NGAL and hsCRP) in n = 67 South African cART-naïve people with HIV.MethodsSanger sequencing was used to determine blood-derived Tat/Vif amino acid sequence diversity. To measure Trp-Kyn metabolites, a LC–MS/MS metabolomics platform was employed using a targeted approach. To measure immune markers, Enzyme-linked immunosorbent assays and the Particle-enhanced turbidimetric assay was used.ResultsAfter adjusting for covariates, sCD163 (p = 0.042) and KA (p = 0.031) were higher in participants with Tat signatures N24 and R57, respectively, and amino acid variation at position 24 (adj R2 = 0.048, β = -0.416, p = 0.042) and 57 (adj R2 = 0.166, β = 0.535, p = 0.031) of Tat were associated with sCD163 and KA, respectively.ConclusionsThese preliminary findings suggest that amino acid variation in Tat may have an influence on underlying pathogenic HIV-1 mechanisms and therefore, this line of work merits further investigation.

Disparities in outcomes by race and ethnicity in the Canadian cystic fibrosis population

BackgroundCystic Fibrosis has historically been described as a disease that affects people of European ancestry. Consequently, much of what we know about CF is based on evidence generated from data collected in white individuals. This may lead to systematic bias in how non-white people with CF are diagnosed and treated. In this study we compared clinical outcomes between the white and non-white people with CF in Canada. MethodsCanadian CF Registry data collected between 2000 and 2019 were used in this population-based cohort study. Demographic characteristics and clinical outcomes of people with CF identified as white and those identified as non-white were compared. Analyses were adjusted for cohort effects but not socioeconomic status. ResultsBetween 2000 and 2019, 5516 people with CF in the Registry were identified as white and 323 were identified as non-white. At diagnosis, the white and non-white groups were similar with respect to sex at birth, age at diagnosis, prevalence of pancreatic insufficiency, and meconium ileus. The non-white group had similar rates of CF-related complications and bacterial infections compared to the white, but worse lung function, worse nutritional status, lower treatment rates, and higher rate of hospitalizations. During the 20-year study period, the non-white group had a 1.85 higher risk of death compared to the white group (HR 95 %CI 1.39; 2.47). InterpretationThere is an urgent need understand why outcomes for Canadians with CF differ between white and non-white individuals, including the role of socioeconomic circumstances.

Initiating or switching to insulin degludec/insulin aspart in a real-world population of adults with type 2 diabetes in Australia: results from a prospective, non-interventional study.

Insulin degludec/insulin aspart (IDegAsp) is a fixed-ratio co-formulation of insulin degludec and insulin aspart for the treatment of people with diabetes and suboptimal glycaemic control. Few real-world studies of IDegAsp treatment have been conducted. Here, we report results from the Australian cohort of the global ARISE study of real-world IDegAsp use. To investigate glycaemic control and other clinical outcomes in people with type 2 diabetes (T2D) treated with IDegAsp in a real-world setting in Australia. A total of 183 adults with T2D initiating or switching to IDegAsp in the Australian cohort of the open-label, non-interventional ARISE study were followed for 26-36 weeks from August 2019 to December 2020. IDegAsp was associated with significant reductions from baseline to end of study (EOS) in mean glycated haemoglobin (estimated change -0.8% (95% confidence interval (CI): -1.05 to -0.56; P < 0.0001)), fasting plasma glucose (-1.6 mmol/L (95% CI: -2.49 to -0.63; P = 0.0017)) and body weight (-2.6 kg (95% CI: -3.68 to -1.55; P < 0.0001)). In insulin-experienced patients, the mean total daily insulin dose did not change significantly (estimated change from baseline to EOS 3.8 (95% CI: -3.70 to 11.21; P = 0.3202)). The proportion of patients experiencing hypoglycaemia numerically decreased during the study (non-severe: 14.2-10.9%; nocturnal non-severe: 4.9-2.2%; and severe: 2.2-0%). Initiating or switching to IDegAsp in a real-world population of people with T2D in Australia was associated with significant improvements in glycaemic control and body weight, and numerically lower levels of hypoglycaemia compared with baseline.

Characterizing barriers to care in migraine: multicountry results from the Chronic Migraine Epidemiology and Outcomes – International (CaMEO-I) study

ObjectiveTo assess rates of traversing barriers to care to access optimal clinical outcomes in people with migraine internationally.BackgroundPeople in need of medical care for migraine should consult a health care professional knowledgeable in migraine management, obtain an accurate diagnosis, and receive an individualized treatment plan, which includes scientific society guideline-recommended treatments where appropriate.MethodsThe Chronic Migraine Epidemiology and Outcomes-International (CaMEO-I) Study was a cross-sectional, web-based survey conducted from July 2021 through March 2022 in Canada, France, Germany, Japan, the United Kingdom, and the United States (US). Respondents who met modified International Classification of Headache Disorders, 3rd edition, criteria for migraine and had Migraine Disability Assessment Scale (MIDAS) scores of ≥ 6 (i.e., mild, moderate, or severe disability) were deemed to need medical care and were included in this analysis. Minimally effective treatment required that participants were currently consulting a health care professional for headache (barrier 1), reported an accurate diagnosis (barrier 2), and reported use of minimally appropriate pharmacologic treatment (barrier 3; based on American Headache Society 2021 Consensus Statement recommendations). Proportions of respondents who successfully traversed each barrier were calculated, and chi-square tests were used to assess overall difference among countries.ResultsAmong 14,492 respondents with migraine, 8,330 had MIDAS scores of ≥ 6, were deemed in need of medical care, and were included in this analysis. Current headache consultation was reported by 35.1% (2926/8330) of respondents. Compared with the US, consultation rates and diagnosis rates were statistically significantly lower in all other countries except France where they were statistically significantly higher. Total appropriate treatment rates were also statistically significantly lower in all other countries compared with the US except France, which did not differ from the US. All 3 barriers were traversed by only 11.5% (955/8330) of respondents, with differences among countries (P < 0.001).ConclusionsOf people with migraine in need of medical care for migraine, less than 15% traverse all 3 barriers to care. Although rates of consultation, diagnosis, and treatment differed among countries, improvements are needed in all countries studied to reduce the global burden of migraine.Trial registrationNA.

Relationship between adherence to bictegravir/emtricitabine/tenofovir alafenamide fumarate and clinical outcomes in people with HIV in Japan: a claims database analysis

A lack of adherence to long-term antiretroviral therapy may impact viral suppression. The current study examined the relationship between medication adherence and clinical outcomes in people with human immunodeficiency virus infection (PWH) receiving bictegravir, emtricitabine, and tenofovir alafenamide fumarate (B/F/TAF). A retrospective cohort study using two Japanese claims databases was conducted. Adherence was measured by the proportion of days covered (PDC). Patients were grouped into 3 PDC category and persistence was estimated by Kaplan-Meier method. Cox regression analysis was performed to investigate whether the PDC was associated with treatment discontinuation. Among 952 patients, 820 (86.1%), 95 (10.0%), and 37 (3.9%) patients were grouped into the PDC ≥ 90%, 80– < 90%, and < 80% groups, respectively. Across all PDC groups, more than 90% of patients who received B/F/TAF were receiving treatment at 1 year. There was no significant difference in the risk of discontinuation between the lower PDC groups (80– < 90% and < 80%) and the PDC ≥ 90% group (0.400 [0.096, 1.661]; 2.244 [0.663, 7.594], hazard ratio [95% confidence interval], respectively). A drug resistance test was implemented for 15 patients, none of whom discontinued B/F/TAF after the test. The results suggest that events that could cause discontinuation, such as virologic failure, were not associated with PDC.

Use of Cannabinoids by People Who Consume Kratom in the United States.

To estimate lifetime, past-year, and past-month prevalence of kratom, cannabis, and cannabidiol-only product use among adults 18 years and older in the United States, using 2 independent datasets. Utilizing (a) the 2022 National Survey on Drug Use and Health (NSDUH) and (b) a 2022 online national convenience sample of adults who use kratom regularly (from our research group at the National Institute on Drug Abuse [NIDA]), we examined key demographic information as well as lifetime, past-year, and past-month substance use and preferences. Among the full sample of adults from the 2022 NSDUH, the prevalence of lifetime use was 49.69% for cannabis, 34.09% for cannabidiol-only products, and 1.93% for kratom. When solely examining participants who have used kratom, both independent datasets showed higher proportions of cannabis use over the lifetime-92.81% (95% confidence interval: 90.31-95.31) in the NSDUH subset and 92.16% (95% confidence interval: 89.37-94.95) in our NIDA sample. Our study demonstrates that people are co-using kratom with cannabis and/or cannabidiol-only products at the same time or during the same time period, though more research is needed to understand people's motivations and practices for such co-use. Co-use might result in herb-herb interactions that may impact research findings and clinical outcomes for people who use kratom.

Advances in diabetes technology to improve the lives of people with cystic fibrosis.

People with cystic fibrosis (CF) are at risk for dysglycaemia caused by progressive beta cell dysfunction and destruction due to pancreatic exocrine disease and fibrosis. CF-related diabetes (CFRD) is a unique form of diabetes that has distinctive features from both type 1 and type 2 diabetes. Recent advances in diabetes technology may be of particular benefit in this population given the complex, multi-system organ involvement and challenging health issues that people with CFRD often face. This review summarises how diabetes technologies, such as continuous glucose monitors (CGMs) and insulin delivery devices: (1) have improved our understanding of CFRD, including how hyperglycaemia affects clinical outcomes in people with CF; (2) may be helpful in the screening and diagnosis of CFRD; and (3) offer promise for improving the management of CFRD and easing the burden that this diagnosis can add to an already medically complicated patient population.

Clinical outcomes in people with diabetes-related foot infections: Analysis from a limb preservation service infection database.

Diabetes-related foot infections are common and represent a significant clinical challenge. There are scant data about outcomes from large cohorts. The purpose of this study was to report clinical outcomes from a large cohort of people with diabetes-related foot infections. A tertiary referral hospital limb preservation service database was established in 2018, and all new episodes of foot infections were captured prospectively using an electronic database (REDCap). People with foot infections between January 2018 and May 2023, for whom complete data were available on infection episodes, were included. Infection outcomes were compared between skin and soft tissue infections (SST-DFI) and osteomyelitis (OM) using chi-square tests. Data extraction identified 647 complete DFI episodes in 397 patients. The data set was divided into two cohorts identifying each infection episode and its severity as either SST-DFI (N=326, 50%) or OM (N=321, 50%). Most infection presentations were classified as being moderate (PEDIS 3=327, 51%), with 36% mild (PEDIS 2=239) and 13% severe (PEDIS 4=81). Infection resolution occurred in 69% (n=449) of episodes with failure in 31% (n=198). Infection failures were more common with OM than SST-DFI (OM=140, 71% vs. SST-DFI=58, 29%, p<0.00001). In patients with SST-DFI a greater number of infection failures were observed in the presence of peripheral arterial disease (PAD) compared to the patients without PAD (failure occurred in 30% (31/103) of episodes with PAD and 12% (27/223) of episodes without PAD; p<0.001). In contrast, the number of observed infection failures in OM episodes were similar in patients with and without PAD (failure occurred in 45% (57/128) of episodes with PAD and 55% (83/193) of episodes without PAD; p=0.78). This study provides important epidemiological data on the risk of poor outcomes for DFI and factors associated with poor outcomes in an Australian setting. It highlights the association of PAD and treatment failure, reinforcing the need for early intervention to improve PAD in patients with DFI. Future randomised trials should assess the benefits of revascularisation and surgery in people with DFI and particularly those with OM where outcomes are worse.

Association between calf circumference and mortality in people receiving home enteral nutrition: A retrospective cohort study.

Among the anthropometric measurements, calf circumference has been widely used as a simple and practical method to diagnose low muscle mass and sarcopenia. However, the association between this measurement and clinical outcomes in people receiving home enteral nutrition is still unknown. Therefore, this study aimed to investigate the association of calf circumference with mortality, discharge from home enteral nutrition, continuity in home enteral nutrition, and new hospitalizations in adult and older adult people. This retrospective cohort study used secondary data, including people aged ≥18 years receiving home enteral nutrition. The association between calf circumference and the outcomes of mortality, discharge from home enteral nutrition, and continuity in home enteral nutrition was analyzed using multinomial logistic regression. The association between calf circumference and the occurrence of new hospitalizations was investigated using binary logistic regression. Among the 899 people included in the study, 470 were men (52.3%), the median age was 72 years (interquartile range, 56.5-82), and 850 had inadequate calf circumference (94.5%). As calf circumference increased, the odds of mortality decreased and the probability of discharge from home enteral nutrition and continuity in home enteral nutrition increased. Furthermore, in people with oncologic diagnoses, the odds of new hospitalizations were reduced by 71.9% for each additional centimeter in calf circumference. These findings underline the importance of using calf circumference as part of the nutrition assessment because it is a simple, easy, and cost-effective method that can also be used as a tool to predict clinical outcomes.

Feasibility Study the Effectiveness of Self-care Promoting Program on Self-care Behavioral and Clinical Outcomes in People with Corneal Transplantation: A Quasi-experiment Study

Corneal transplantation is the most effective treatment for visual impairment caused by corneal blindness and can improve patients’ quality of vision. However, pre- and post-operative self-care is necessary to reduce the risk of complications and graft rejection. This one-group, quasi-experimental design with repeated measures aimed to determine the feasibility and effectiveness of self-care promoting programs on self-care behavior, anxiety, and clinical outcomes in individuals with corneal transplantation. Thirty participants who met the inclusion criteria were purposively recruited from a corneal excellence center in Bangkok, Thailand, from October 2021 to August 2022. The data collection instruments included the Demographic and Health Data Forms, the Self-Care Behavior Questionnaire, and the Self-Rating Anxiety Scale. The data were analyzed using descriptive statistics, paired t-tests, and Friedman and Wilcoxon signed-rank tests. The program was found to be feasible, with all participants able to attend for 30 days postoperation. In terms of effectiveness, participants demonstrated improved self-care behavior and reduced anxiety compared to pre-program levels. Visual acuity also showed improvement 30 days postoperation, with 83.3% of participants having a clear corneal graft. These findings are significant for nursing practice, as they suggest that this program could be a promising tool for enhancing self-care behavior in individuals undergoing corneal transplantation. Nurses could potentially use this program to promote self-care behavior, alleviate anxiety, and enhance clinical outcomes. However, further research with randomized control is necessary before widespread implementation can be recommended.

Psychosocial factors in knee osteoarthritis: Scoping review of evidence and future opportunities

ObjectiveIdentify, describe and produce an evidence map of studies investigating psychosocial factors association with, or effect on, clinical outcomes for people with knee osteoarthritis. MethodsScoping review of interventional and observational studies was performed. Medline (Ovid), Embase (Ovid), CINAHL, PsycInfo and Web of Science were searched on the 15th May 2023. Screening, data extraction and analysis was performed by two independent researchers. Extracted information included characteristics of studies plus which psychosocial factors were used to investigate association with, or effect on, clinical outcome(s). Descriptive statistics summarized the study design, temporal trend, geographic distribution, frequency of each psychosocial factor and whether associations/effects were observed. Results23,065 records were screened, with 108 studies selected. Eighty-two percent of studies (n=89/108) were cross-sectional in design. Number of studies increased over time and spanned 28 countries. Most research originated from the Americas region (55%, 59/108). Twenty-four psychosocial factors (11 psychological, 13 social) were identified. Depression (47%, n=48/102) and education (28%, n=29/102) were the most frequently reported psychological and social factors, respectively. Psychological factors were often reported to have an association with/effect on pain (81%, n=71/88) and physical function (75%, n=56/74). Social factors were less frequently reported to have an association with or effect on pain (57%, n=46/81) and physical function (50%, n=18/36). ConclusionPsychosocial factors are often associated with clinical outcomes for people with knee osteoarthritis. High-quality longitudinal studies examining a wide range of psychosocial factors across diverse cultural and geographical settings are key to continue informing the development of biopsychosocial models of care.

Impact of molecular ciprofloxacin resistance testing in management of gonorrhoea in a large urban clinic

ObjectivesAntibiotic resistance in gonorrhoea is of significant public health concern with the emergence of resistance to last-line therapies such as ceftriaxone. Despite around half of Neisseria gonorrhoeae isolates tested in...

SPIRIT: Assessing Clinical Parameters Associated with Using IDegLira in Patients with Type 2 Diabetes in a Real-World Setting in Colombia.

Insulin degludec/liraglutide (IDegLira) is a fixed-ratio combination of insulin degludec (a basal insulin) and liraglutide (a glucagon-like peptide-1 receptor agonist [GLP-1RA]). This study aimed to investigate clinical outcomes in people with type 2 diabetes mellitus (T2DM) after initiating IDegLira treatment in a real-world setting in Colombia. SPIRIT is a non-interventional, single-arm, retrospective chart review study to assess clinical outcomes in people with T2DM. Participating patients were switched from a treatment regimen of basal insulin (with or without oral antidiabetics [OADs]) and started on treatment with IDegLira a minimum of 26 ± 6weeks before the data collection start date. Data were collected from the medical records of 175 patients in ten clinical centers across Colombia. Compared with baseline, there was a significant reduction in glycated hemoglobin (HbA1c) (1.3%; 95% confidence interval [CI] -1.6 to -1.0; p < 0.0001) after 26 ± 6weeks of follow-up. The mean HbA1c at baseline and at the end of the study was 9.1% and 7.8%, respectively. In addition, IDegLira significantly reduced absolute body weight by 1kg (95% CI -1.5 to -0.5; p < 0.0001), from a mean of 76.1kg at baseline to 75.1kg after follow-up. The mean IDegLira dose at the end of the study was 21.3 U, and no severe hypoglycemic events were observed during the follow-up period. In real-world practice, initiating IDegLira in patients with T2DM previously treated with basal insulin (± OAD) was associated with improved glycemic control, reduced body weight and reduced risk of hypoglycemia. ClinicalTrials.gov identifier: NCT05324462.

Pharmacist-Driven Rapid Initiation of Antiretroviral Therapy Decreases Time to Viral Suppression in People With HIV.

Rapid initiation of antiretroviral therapy (rapid ART) improves clinical outcomes in people with HIV and is endorsed by clinical guidelines. However, logistical challenges limit widespread implementation. We describe an innovative rapid ART model led by pharmacists and its impact on clinical outcomes, including time to viral suppression (TVS). On 1 January 2019, we implemented Pharmacist-Driven Rapid ART (PHARM-D RAPID ART), including rapid ART initiation by pharmacists. Our retrospective cohort study compared TVS, using a Cox proportional hazards model, and clinical outcomes among individuals with a new HIV diagnosis before (1 January 2017 to 31 December 2017) and after (1 January 2019 to 31 December 2019) implementation. A total of 108 individuals were included. TVS was significantly shorter (P < .001) for the PHARM-D RAPID ART group (n = 51) compared with the preimplementation group (n = 57) (median: 30 days and 66 days, respectively). Those in the PHARM-D RAPID ART group were significantly more likely to achieve VS at any given time during the study period (adjusted hazard ratio: 3.47 [95% confidence interval, 2.25-5.33]). A total of 94.1% (48/51) of patients in the PHARM-D RAPID ART group were retained in care at 1 year. With a median follow-up of 2.4 years in the PHARM-D RAPID ART group, 98% remained suppressed at last recorded viral load. A pharmacist-driven model for rapid ART delivery decreases TVS with high rates of retention in care and durable VS. This model could improve clinical outcomes and increase program feasibility and sustainability.

Patient-Led Urate Self-Monitoring to Improve Clinical Outcomes in People With Gout: A Feasibility Study.

Self-monitored point-of-care urate-measuring devices are an underexplored strategy to improve adherence to urate-lowering therapy and clinical outcomes in gout. This study observed patient-led urate self-monitoring practice and assessed its influence on allopurinol adherence, urate control, and health-related quality of life. People with gout (n = 31) and prescribed allopurinol self-monitored their urate concentrations (HumaSens2.0plus) at baseline and thereafter monthly for 12 months (3 months per quarter). Adherence to allopurinol was measured using medication event monitoring technology (Medication Event Monitoring System cap). Time spent below the target urate concentration (<0.36 mmol/L) was determined. Health-related quality of life was measured using a survey (EuroQoL EQ-5D-5L). Gout flares were recorded. Two-tailed Spearman correlation and the Wilcoxon matched-pairs signed-rank test (P < 0.05) were used for statistical comparisons. Most participants were male (94%) and had urate concentrations below the target (74%) at baseline. Overall, seven participants demonstrated repeated periods of "missed doses" (two or fewer allopurinol doses missed consecutively) and "drug holidays" (three or more missed doses). Most participants (94%) persisted with allopurinol. Time spent within the target urate concentration increased 1.3-fold (from 79% to 100%; P = 0.346), and the incidence of gout flares decreased 1.6-fold (from 8 to 5; P = 0.25) in the final quarter compared to that in the first quarter of the study. Health-related quality of life was reduced for participants reporting at least one gout flare (median utility values 0.9309 vs 0.9563, P = 0.04). Patient-led urate self-monitoring may support the maintenance of allopurinol adherence and improve urate control, thus reducing the incidence of gout flares. Further research on patient-led urate self-monitoring in a randomized controlled study is warranted.