Global aHUS Registry Analysis of Patients Switching to Ravulizumab From Eculizumab.

Introduction: Atypical hemolytic uremic syndrome (aHUS) is a progressive rare disease that, if untreated, can result in severe organ damage and death. Ravulizumab, a next-generation terminal complement inhibitor, provides immediate, complete, and sustained complement C5 inhibition. Real-world data in patients with aHUS who switched to ravulizumab from eculizumab are lacking. Methods: The Global aHUS Registry is a multicenter study (NCT01522183) collecting data on adult or pediatric patients with an aHUS diagnosis, regardless of treatment. Patient characteristics, genetic data, hematological and renal parameters, clinical events (e.g., dialysis and kidney transplantation), and adverse events (AEs) were extracted from patients who switched to ravulizumab from eculizumab up to July 3, 2023. Results: Overall, 60 patients switched to ravulizumab (adult: n = 43; pediatric: n = 17); 11 patients were excluded from effectiveness and genetic analyses (N = 49; adult: n = 40; pediatric: n = 9) because they received <3 months ravulizumab treatment and/or had >1 month between eculizumab discontinuation and ravulizumab initiation. Pathogenic complement variants were identified in 11 of 49 patients (22%); the most common was a complement factor H variant (n = 5/49 [10%]). During ravulizumab treatment, 20 AEs occurred in 13 patients, with no unexpected AEs and only 3 treatment-related AEs (infusion reaction, headaches, and fatigue). No meningococcal infections or deaths were reported. No new events of dialysis, kidney transplantation, or thrombotic microangiopathy were reported. Renal and hematological parameters remained stable after switching to ravulizumab. Conclusion: This is the first real-world cohort analysis of data from patients treated with ravulizumab and reinforces the real-world safety and effectiveness data of ravulizumab in patients with aHUS who switched from eculizumab.

Originalbeiträge (Originals). Patientencharakteristika an einer psychodynamischen Ausund Weiterbildungsambulanz.

Patient characteristics at a psychodynamic training institute Outpatient clinics affiliated with psychotherapeutic training institutions play a crucial role in ensuring the quality of future psychotherapists' training. OBJECTIVE: In the present study we examined the characteristics of patients in terms of symptomatology and psychodynamic dimensions. METHODS: The study utilized online questionnaires completed by n = 421 patients between September 2020 and March 2021. These questionnaires gathered information on sociodemographics, symptomatology (PHQ-D), relationship dynamics (IIP), personality functioning (OPD-SQS, IPO-16), and intrapsychic conflicts (OPD-KF). RESULTS: The sample consisted of 71.0 % females, with 65 % having prior experience with psychotherapeutic treatments. Notably, 74.9 % of the patients fulfilled the criteria of a depressive disorder in PHQ-D (with 34.8 % identified as Major Depressive Disorder, MDD). Additionally, 53.1 % of all patients surpassed the threshold for the diagnosis of a personality disorder based on the IPO-16. DISCUSSION: Findings suggest that patients seeking treatment at these clinics exhibit significant psychological distress and often have a history of prior psychotherapeutic interventions.

Trends in hip fracture surgery in the United States from 2016 to 2021: patient characteristics, clinical management, and outcomes.

INTRODUCTION: Hip fractures are a serious health concern and a major contributor to healthcare resource utilisation. We aimed to investigate nationwide trends in the USA in patient characteristics and outcomes in patients after hip fracture repair surgery. METHODS: From the Premier Healthcare dataset, we extracted patient encounters for surgical hip fracture repair from 2016 to 2021. Patient characteristics, comorbidities, complications, and anaesthetic and surgical details were analysed. Cochran-Armitage trend tests and simple linear regression were used to determine trends. RESULTS: We included 347 086 hip fracture repair encounters. Notable trends included the following: median patient age declined from 82 yr [interquartile range: 73-88 yr] to 81 yr [interquartile range: 73-88 yr], (P-value=0.002), the proportion of female patients decreased from 68% to 66.2% (P-value=0.019); internal fixation was the most common intervention initially, but with a declining percentage from 49.9% to 43.8% (P-value <0.001); in general, patients carried a greater comorbidity burden, with the proportion with three or more Elixhauser comorbidities increasing from 56.4% to 58.6% (P-value=0.006); general anaesthesia remained the most common anaesthetic technique, from 68.90% to 56.80% without a significant trend; per 1000 inpatient days, the most common complication remained acute renal failure; despite a higher comorbidity burden, no complication showed a statistically significant upward trend, and many showed downward trends. CONCLUSIONS: Over the 6-yr period from 2016 to 2021, a majority of hip fracture repairs continued to be performed under general anaesthesia but with that percentage declining over time. Notable trends included a lower percentage of female patients, an increase in femoral neck fractures, a higher comorbidity burden among patients, and a decrease in complications.

One type of graft for reconstruction of the ACL does not suit all patients based on their characteristics and sports: a scoping review.

The selection of graft type for anterior cruciate ligament reconstruction remains a topic of debate, taking into consideration patient characteristics, as well as the type and level of sports involvement. The aim of this scoping review was to investigate patient characteristics that might influence the selection of graft type for anterior cruciate ligament reconstruction. PubMed and Scopus were searched to identify articles for inclusion. All included studies focused on one or more patient characteristics involved in the decision-making process regarding anterior cruciate ligament reconstruction autograft, including the hamstrings tendon (HT), patellar tendon (BPTB) and quadriceps tendon (QT). Out of the 1,977 initial studies, 27 studies were included in this review. The BPTB graft seems to be the preferred choice in young patients, females, and athletes-especially those engaged in pivoting sports. The HT graft seems to be the preferred choice in less active and older patients, along with those involved in sports where knee extensors are vital. The HT graft is not preferable in patients with a small body height and graft diameter. Moreover, surgeon preferences were also of importance for graft selection. The success of a specific graft type in anterior cruciate ligament reconstruction is highly dependent on the patient's characteristics and type of sport. Patient characteristics such as age, gender, body height, graft diameter, and the patient's activity level should all be considered when choosing the appropriate graft type.

Attrition of older adults in web-based health interventions: Survival analysis within an observational cohort study.

To identify demographics and personal motivation types that predict dropping out of eHealth interventions among older adults. We conducted an observational cohort study. Participants completed a pre-test questionnaire and got access to an eHealth intervention, called Stranded, for 4 weeks. With survival and Cox-regression analyses, demographics and types of personal motivation were identified that affect drop-out. Ninety older adults started using Stranded. 45.6% participants continued their use for 4 weeks. 32.2% dropped out in the first week and 22.2% dropped out in the second or third week. The final multivariate Cox-regression model which predicts drop-out, consisted of the variables: perceived computer skills and level of external regulation. Predicting the chance of dropping out of an eHealth intervention is possible by using level of self-perceived computer skills and level of external regulation (externally controlled rewards or punishments direct behaviour). Anticipating to these factors can improve eHealth adoption.

Australia's first cardiac emergency department: Patient profile, activity and performance in the initial 6 months.

OBJECTIVE: To profile the initial 6-month experience at the Victorian Heart Hospital (VHH) cardiac emergency (CE). The primary objective was to describe VHH CE patient characteristics, including presenting complaint, final diagnosis and disposition. Secondary objectives were to report on patient numbers, patient source and quality indicator performance including ambulance off-load by 40 min, waiting time and length of stay (LOS). METHODS: A retrospective review included all patients who presented to the VHH CE from 9 March 2023 to 8 September 2023. Patient reports containing the relevant clinical information were generated from the CE electronic medical record system. Diagnoses of MI were checked for accuracy by full record review. RESULTS: There were 3303 CE presentations in the first 6 months of operation, of which 6% were transferred from other sites. Median age was 65 years (interquartile range [IQR]: 53-77), 56% were males; the most common presenting complaints were presumed cardiac chest pain (67%) and arrhythmia (17%). The admission, discharge and transfer rates were 38%, 54% and 8%, respectively. In total, 15% were diagnosed with MI. The most common diagnoses for discharged and admitted patients were non-specific chest pain (57%) and ST-elevation MI (22%), respectively. Ambulance off-load by 40 min was met for 96%. Median waiting time was 6 min (IQR: 3-10). Median CE LOS for discharged and admitted patients was 3.2 h (IQR: 2.5-4.0) and 3.7 h (IQR: 1.8-6.0), with 75% and 56% being <4 h, respectively. CONCLUSIONS: The population predominantly had cardiovascular disease as expected. Some performance indicators, including ED LOS, were identified as requiring intervention.

Exploring Patterns and Disparities in E-Consult Referrals: An Analysis of Patient and Community Factors in Colorado Health Care.

Objective: Electronic consultations (e-consults) provide a strategic solution to address challenges in health care systems related to cost management and access to care. This study aims to investigate the multilevel patient characteristics associated with higher frequency of receiving e-consults and increased likelihood of completion. Materials and Methods: University of Colorado's electronic medical record were analyzed to study factors influencing referral types (e-consult vs. standard) and their completion rates from April 2018 to September 2023. Multivariate probit regression assessed the impact of patient-level and community-level factors (urban-rural classification, Social Vulnerability Index, and technology accessibility) on e-consult referrals and completion. Results: In 263,882 records, 92.5% were standard referrals, and 7.4% were e-consult referrals. Analysis showed that females were less likely than males (OR = 0.95, 95%CI[0.93, 0.96]), and Blacks were more likely than Whites (OR = 1.03, 95%CI[1.01,1.06]) to receive e-consult referrals. Medicaid patients had lower odds compared to those with Medicare only (OR = 1.04, 95%CI[1.00,1.07]), and rural residency was associated with lower odds (OR = 0.80, 95%CI[0.73,0.88]) of e-consult referral. Factors such as areas with higher population without internet subscription (OR = 1.03, 95%CI[1.01,1.04]) and higher social vulnerabilities (OR = 1.26, 95%CI[1.16,1.37]) increased e-consult odds. Black patients were less likely to have their referrals completed compared to Whites. Patients who resided in regions with limited computer and smartphone access, as well as higher social vulnerabilities, showed decreased odds of referral completion. Discussions and Conclusion: This study highlights the need for partnering with a variety of health care organizations, especially those serving low-income and disadvantaged populations, to enhance health care access equity through the use of e-consults.

Real-world treatment patterns of patients with major depressive disorder treated with Auvelity in the United States.

AIMS: Major depressive disorder (MDD) is a prevalent, chronic disorder. Auvelity (dextromethorphan-bupropion) is a novel, oral N-methyl-D-aspartate (NMDA) receptor antagonist and sigma-1 receptor agonist approved (August 2022) by the FDA for treating MDD in adults. This is the first analysis on real-world Auvelity usage in the United States. METHODS: Adult patients initiating Auvelity in the Symphony IDV databases by September 2023 were identified (index date: the first Auvelity claim). Patients had continuous eligibility over the 12-month pre-index period and ≥1 MDD diagnosis (ICD-10-CM codes: F32.*, F33.*) over the 5-year pre-index period. Demographic and clinical characteristics, comorbidities, prior MDD-related medications, and Auvelity initiation status were assessed. RESULTS: This analysis included 22,288 patients with MDD treated with Auvelity (mean age 45.1 years; 68.1% women); 40.0% lived in the South and 58.5% had commercial insurance. Comorbidities included mental health disorders (53.5%; 47.6% had anxiety disorders). Overall, 83.7% of the patients had received treatment with selective serotonin reuptake inhibitors (SSRIs; 54.9%), the norepinephrine-dopamine reuptake inhibitor (NDRI [bupropion]; 40.4%), and/or serotonin-norepinephrine reuptake inhibitors (SNRIs; 35.9%) over the 12-month pre-index period. The last MDD-related treatment prior to Auvelity comprised SSRI (22.4%), SNRI (13.2%), and NDRI (12.8%) monotherapies; 294 (1.3%) patients received esketamine. In total, 6,418 (28.8%) patients initiated Auvelity as monotherapy vs 15,870 (71.2%) as an add-on; Auvelity was most frequently added to an SSRI alone (10.7%) or SNRI alone (6.5%). A total of 2,254 (10.1%) patients initiated Auvelity without prior treatment in the 12-month pre-index period. LIMITATIONS: Incomplete data due to reporting; diagnoses captured subject to coding error; and limited generalizability to other populations. CONCLUSIONS: Using a large demographically distributed claims database, 22,288 patients with MDD initiated Auvelity within a year of its approval; 10.1% were treatment-naïve and 28.8% initiated Auvelity as monotherapy. Most patients had mental health-related comorbidities and attempted various MDD-related treatments prior to Auvelity.

Major depressive disorder (medical terminology for "depression") is a common medical condition that makes people feel persistently sad or hopeless, affecting their ability to handle daily activities. Effective treatment, which may include medication, is crucial for improving their quality of life. This study explores how people in the United States use a new medication called Auvelity to treat depression. Researchers reviewed the medical records of over 22,000 adults with depression, looking at their age, gender, location, type of health insurance, other health conditions, and use of other depression medications. The study focused on people who started using Auvelity in the first year after its Food and Drug Administration (FDA) approval. On average, Auvelity users were 45 years old. They lived across various regions of the US, had different types of health insurance, and over two-thirds were women. Many Auvelity users had other mental health disorders, including anxiety. Most had tried different types of medications for depression in the previous year, while about 10% had not used any other depression medicines in the previous year. When starting Auvelity, almost one-third of patients used it as their only depression medicine. Over two-thirds of patients started Auvelity alongside another depression medicine. Initial Auvelity prescriptions were issued by a diverse range of medical professionals, including psychiatrists, primary care physicians, nurse practitioners, and physician assistants. These findings provide valuable insights into how this new medicine is used in real life and can inform treatment decisions of healthcare providers who help manage depression in their patients.

Patient-pharmacist relationship dynamics: a mediation analysis of patient characteristics and reported outcomes.

Background: While previous research underscores the independent effect of the pharmacist-patient relationship on patient outcomes, it did not delve further into the patient-pharmacist relationship dynamics and their effects on reported outcomes. Therefore, this study aimed to assess whether patient-pharmacist relationship aspects mediate the association between patient personal and health characteristics, on the one hand, and adherence to medication and quality of life, on the other hand (QOL). Methods: An online cross-sectional study was conducted between April 11 and 27, 2023. It enrolled 865 adults from all Lebanese governorates and used validated scales to measure the various concepts. Results: The mean age was 32.52 ± 14.56 years, and 68.8% were female. Also, 79.3% reported having no chronic disease, and 57.7% indicated that getting nonprescription medications was the main reason for visiting a community pharmacy. The average routine intake of medications per day was 0.87 ± 1.78. Our key findings reveal a compelling association between worse health status and both increased medication non-adherence and reduced QOL. Sociodemographic factors were found to be correlated with QOL. Despite the considerable impact of demographic factors on patient expectations, our study challenges the expected mediation role of the pharmacist-patient relationship and counseling time on medication adherence. Nevertheless, patient expectations partially mediated the relationship between sociodemographic characteristics and QOL. Conclusion: This study sheds light on the intricate dynamics between patient characteristics, health status, medication adherence, and QOL within the context of the patient-pharmacist relationships.

Patient Characteristics Associated with Receiving Gender-Affirming Hormone Therapy in the Veterans Health Administration.

Purpose: This study aimed to examine patient characteristics associated with receipt of gender-affirming hormone therapy in the Veterans Health Administration (VHA). Methods: This cross-sectional study included a national cohort of 9555 transgender and gender diverse (TGD) patients with TGD-related diagnosis codes who received care in the VHA from 2006 to 2018. Logistic regression models were used to determine the association of health conditions and documented social stressors with receipt of gender affirming hormone therapy. Results: Of the 9555 TGD patients, 57.4% received gender-affirming hormone therapy in the VHA. In fully adjusted models, patients who had following characteristics were less likely to obtain gender-affirming hormones in the VHA: Black, non-Hispanic versus white (adjusted odds ratio [aOR]: 0.61; 95% confidence interval [CI]: 0.52-0.72), living in the Northeast versus the West (aOR: 0.72; 95% CI: 0.62-0.84), a documented drug use disorder (aOR: 0.56; 95% CI: 0.47-0.68), ≥3 versus no comorbidities (aOR: 0.44; 95% CI: 0.34-0.57), and ≥3 versus no social stressors (aOR: 0.42; 95% CI: 0.30-0.58; all p<0.001). Younger patients aged 21-29 years were almost 3 times more likely to receive gender affirming hormone therapy in the VHA than those aged ≥60 (aOR: 2.98; 95% CI: 2.55-3.47; p<0.001). Conclusion: TGD individuals who were older, Black, non-Hispanic, and had more comorbidities and documented social stressors were less likely to receive gender-affirming hormone therapy in the VHA. Further understanding of patient preferences in addition to clinician- and site-level determinants that may impact access to gender-affirming hormone therapy for TGD individuals in the VHA is needed.

Prostate cancer across four countries in the Middle East: a multi-centre, observational, retrospective and prognostic study.

Prostate cancer (PC) is the second most prevalent cancer in males, with a steadily increasing incidence in the Middle East (ME). The aim of this study was to capture real-world data on the characteristics, disease progression, and treatment patterns among PC patients in the ME. This was a retrospective, observational, multi-centre study conducted across ten hospitals/research centers in Lebanon, Kingdom of Saudi Arabia, Iraq and Kuwait. Data were abstracted from medical records of 615 male patients who were diagnosed with PC between January 2012 and the site initiation date (December 2018-May 2019) and received at least one PC treatment/intervention. The observation period ranged between 84 and 88 months. Data were collected on demographics, clinical characteristics, time to progression to the subsequent clinical state or therapy (progression from localised/locally advanced PC to castration and to metastatic PC (metastatic castration-sensitive PC (mCSPC) or metastatic castration-resistant PC (mCRPC)), progression from mCSPC to mCRPC, and mCRPC patients' progression to first subsequent line of therapy), treatment patterns, and mortality. Most patients had localised/locally advanced PC (57.7%), followed by mCSPC (37.4%), and mCRPC (4.1%) at the time of inclusion in the study. Most patients were at tumours, nodes and metastases (TNM) stage IIIa (40.1%) or TNM stage IVb (27.8%) at study entry. Median time to metastatic disease, castration-resistance and next line therapy was 84 months (95% CI: 68-84), 41 months (95% CI: 30-56) and 7 months (95% CI: 0-41), respectively. The mortality rate was 3.6%. Disease progression was most common among patients with mCSPC (35.1%) or mCRPC (14.8%), and treatment discontinuation was most common among patients with mCRPC (36.6% treatments discontinued). The results show that most patients were at an advanced TNM stage at study entry, suggestive of a lack of awareness regarding PC. Disease progression was most common among patients with metastatic disease, reflecting the challenge of treating metastatic disease and highlighting the need for novel treatments.

Characteristics and outcomes of patients admitted to intensive care units in Uganda: a descriptive nationwide multicentre prospective study.

Intensive care unit (ICU) mortality rates have decreased over time. However, in low-and lower-middle income countries (LMICs), there remains an excess ICU mortality with limited understanding of patient characteristics, treatments, and outcomes from small single centre studies. We aimed therefore, to describe the characteristics, therapies and outcomes of patients admitted to all intensive care units in Uganda. A nationwide prospective observational study including all patients admitted Uganda's ICUs with available daily charts was conducted from 8th January 2018 to 1st April 2018. Socio-demographics and clinical characteristics including worst vital signs in the first 24 h of admission were recorded with calculation of the National Early Warning Score (NEWS-2) and quick Sequential Organ Function Assessment (qSOFA) score. ICU interventions were recorded during the ICU stay and patients were followed up to 28 days in ICU. The primary outcome was 28 day ICU mortality. Three-hundred fifty-one patients were analysed with mean age 39 (24.1) years, 205 (58.4%) males with 197 (56%) surgical admissions. The commonest indication for ICU admission was postoperative care (42.9%), 214 (61%) had at least one comorbidity, with hypertension 104 (48.6%) most prevalent and 35 (10%) HIV positive. The 28 day ICU mortality was 90/351 (25.6%) with a median ICU stay of 3 (1-7) days. The highest probability of death occurred during the first 10 days with more non-survivors receiving mechanical ventilation (80% vs 34%; p < 0.001), sedation/paralysis (70% vs 50%; p < 0.001), inotropic/vasopressor support (56.7% vs 22.2%; p < 0.001) and renal replacement therapy (14.4% vs 4.2%; p < 0.001). Independent predictors of ICU mortality included mechanical ventilation (HR 3.34, 95% CI 1.48-7.52), sedation/paralysis (HR 2.68, 95% CI 1.39-5.16), inotropes/vasopressor (HR 3.17,95% CI 1.89-5.29) and an HIV positive status (HR 2.28, 95% CI 1.14-4.56). This study provides a comprehensive description of ICU patient characteristics, treatment patterns, and outcomes in Uganda. It not only adds to the global body of knowledge on ICU care in resource-limited settings but also serves as a foundation for future research and policy initiatives aimed at optimizing ICU care in Sub-Saharan Africa.

Patient Characteristics and the Extent to Which Clinicians Involve Patients in Decision Making: Secondary Analyses of Pooled Data.

BACKGROUND: The occurrence of shared decision making (SDM) in daily practice remains limited. Various patient characteristics have been suggested to potentially influence the extent to which clinicians involve patients in SDM. OBJECTIVE: To assess associations between patient characteristics and the extent to which clinicians involve patients in SDM. METHODS: We conducted a secondary analysis of data pooled from 10 studies comparing the care of adult patients with (intervention) or without (control) a within-encounter SDM conversation tool. We included studies with audio(-visual) recordings of clinical encounters in which decisions about starting or reconsidering treatment were discussed. MAIN MEASURES: In the original studies, the Observing Patient Involvement in Decision Making 12-items (OPTION12 item) scale was used to code the extent to which clinicians involved patients in SDM in clinical encounters. We conducted multivariable analyses with patient characteristics (age, gender, race, education, marital status, number of daily medications, general health status, health literacy) as independent variables and OPTION12 as a dependent variable. RESULTS: We included data from 1,614 patients. The between-arm difference in OPTION12 scores was 7.7 of 100 points (P < 0.001). We found no association between any patient characteristics and the OPTION12 score except for education level (p = 0.030), an association that was very small (2.8 points between the least and most educated), contributed mostly by, and only significant in, control arms (6.5 points). Subanalyses of a stroke prevention trial showed a positive association between age and OPTION12 score (P = 0.033). CONCLUSIONS: Most characteristics showed no association with the extent to which clinicians involved patients in SDM. Without an SDM conversation tool, clinicians devoted more efforts to involve patients with higher education, a difference not observed when the tool was used. HIGHLIGHTS: Most sociodemographic patient characteristics show no association with the extent to which clinicians involve patients in shared decision making.Clinicians devoted less effort to involve patients with lower education, a difference that was not observed when a shared decision-making conversation tool was used.SDM conversation tools can be useful for clinicians to better involve patients and ensure patients get involved equally regardless of educational background.

Relationships between the Structural Characteristics of General Medical Practices and the Socioeconomic Status of Patients with Diabetes-Related Performance Indicators in Primary Care.

The implementation of monitoring for general medical practice (GMP) can contribute to improving the quality of diabetes mellitus (DM) care. Our study aimed to describe the associations of DM care performance indicators with the structural characteristics of GMPs and the socioeconomic status (SES) of patients. Using data from 2018 covering the whole country, GMP-specific indicators standardized by patient age, sex, and eligibility for exemption certificates were computed for adults. Linear regression models were applied to evaluate the relationships between GMP-specific parameters (list size, residence type, geographical location, general practitioner (GP) vacancy and their age) and patient SES (education, employment, proportion of Roma adults, housing density) and DM care indicators. Patients received 58.64% of the required medical interventions. A lower level of education (hemoglobin A1c test: ß = -0.108; ophthalmic examination: ß = -0.100; serum creatinine test: ß = -0.103; and serum lipid status test: ß = -0.108) and large GMP size (hemoglobin A1c test: ß = -0.068; ophthalmological examination ß = -0.031; serum creatinine measurement ß = -0.053; influenza immunization ß = -0.040; and serum lipid status test ß = -0.068) were associated with poor indicators. A GP age older than 65 years was associated with lower indicators (hemoglobin A1c test: ß = -0.082; serum creatinine measurement: ß = -0.086; serum lipid status test: ß = -0.082; and influenza immunization: ß = -0.032). Overall, the GMP-level DM care indicators were significantly influenced by GMP characteristics and patient SES. Therefore, proper diabetes care monitoring for the personal achievements of GPs should involve the application of adjusted performance indicators.

Psychological assessment of patients on the heart transplant waiting list: A single center experience.

OBJECTIVE: To analyze the data of the psychological assessment, focusing attention on the quality of life and the psychological status of patients who are listed for heart transplant. METHODS: All heart failure patients listed for heart transplant at the Cardiac Surgery Unit of Bari University, Italy, were evaluated from September to November 2023, by administering the Symptom Checklist-90-R (SCL-90-R) and the Short Form Health Survey 36 (SF-36). RESULTS: Overall, 27 patients were studied. Mean age was 60 years, 88% were males. One third of the patients showed a clinically significant overall mental distress. The symptoms leading to domains such as somatization (55.55%), anxiety (40.74%) and depression (33.33%) were frequently observed. The majority of the population studied (96.30%) showed low levels of perceived physical health status, while 59,62% of them presented levels of perceived physical health status below normal ranges. CONCLUSIONS: Heart transplant candidates show elements of overall mental distress and low quality of life related to physical health status.

Recruitment strategies and retention rates for five National Dental PBRN studies.

Background: We describe a retrospective assessment of practitioner and patient recruitment strategies, patient retention strategies, and rates for five clinical studies conducted in the National Dental Practice-Based Research Network between 2012 and 2019, and practitioner and patient characteristics associated with retention. Methods: Similar recruitment strategies were adopted in the studies. The characteristics of the practitioners and patients are described. The proportion of patients who either attended a follow-up (FU) assessment or completed an online assessment was calculated. For studies with multiple FU visits or questionnaire assessments, rates for completing each FU were calculated, as were the rates for completing any and for completing all FU assessments. The associations of practitioner and patient characteristics with all clinic FU visits, and with the completion of all assessments for a study were ascertained. Results: Overall, 591 practitioners and 12,159 patients were included. FU rates by patients for any assessment varied from 91% to 96.5%, and rates for participating in all assessments ranged from 68% to 87%. The mean total number of patients each practitioner recruited was 21 (sd = 15); the mean number per study was 13 (sd = 7). For practitioners, practice type and patient enrollment were associated with greater clinic retention, while only race was associated with their patients completing post-visit online assessments. For patients, age was associated with clinic retention, while female gender, age, race, and education were all associated with greater completion of post-visit online assessments. Conclusion: The Network efficiently recruited practitioners and patients and achieved high patient retention rates for the five studies.

Characteristics of Users and New Initiators of Single- and Multiple-Inhaler Triple Therapy for Chronic Obstructive Pulmonary Disease in Germany.

Purpose: To assess patient characteristics of users and new initiators of triple therapy for chronic obstructive pulmonary disease (COPD) in Germany. Patients and Methods: Retrospective cohort study of patients with COPD and ≥1 prescription for single-inhaler triple therapy (SITT; fluticasone furoate/umeclidinium/vilanterol [FF/UMEC/VI] or beclomethasone dipropionate/glycopyrronium bromide/formoterol [BDP/GLY/FOR]) or multiple-inhaler triple therapy (MITT), using data from the AOK PLUS German sickness fund (1 January 2015-31 December 2019). The index date was the first date of prescription for FF/UMEC/VI or BDP/GLY/FOR (SITT users), or the first date of overlap of inhaled corticosteroid, long-acting ß2-agonist, and long-acting muscarinic antagonist (MITT users). Two cohorts were defined: the prevalent cohort included all identified triple therapy users; the incident cohort included patients newly initiating triple therapy for the first time (no prior use of MITT or SITT in the last 2 years). Patient characteristics and treatment patterns were assessed on the index date and during the 24-month pre-index period. Results: In total, 18,630 patients were identified as prevalent triple therapy users (MITT: 17,945; FF/UMEC/VI: 700; BDP/GLY/FOR: 908; non-mutually exclusive) and 2932 patients were identified as incident triple therapy initiators (MITT: 2246; FF/UMEC/VI: 311; BDP/GLY/FOR: 395; non-mutually exclusive). For both the prevalent and incident cohorts, more than two-thirds of patients experienced ≥1 moderate/severe exacerbation in the preceding 24 months; in both cohorts more BDP/GLY/FOR users experienced ≥1 moderate/severe exacerbation, compared with FF/UMEC/VI and MITT users. Overall, 97.9% of prevalent triple therapy users and 86.4% of incident triple therapy initiators received maintenance treatment in the 24-month pre-index period. Conclusion: In a real-world setting in Germany, triple therapy was most frequently used after maintenance therapy in patients with recent exacerbations, in line with current treatment recommendations.

Triple therapy (a combination of three different respiratory inhaled medications) is recommended for patients with chronic obstructive pulmonary disease (COPD) who experience repeated short-term symptom flare-ups when taking dual therapy (a combination of two different respiratory medications). Previously, patients had to take triple therapy using two or three separate inhalers. More recently, single-inhaler triple therapies have been developed, meaning patients can take all three different medications at the same time via one single inhaler. This study assessed the characteristics of patients who were already receiving triple therapy, or who started triple therapy (either via multiple inhalers or a single inhaler), in Germany between January 2015 and December 2019. In total, 18,630 patients who were already receiving triple therapy during the study period, and 2932 patients who newly started using triple therapy were included. The study reported that more than two-thirds of included patients had experienced at least one flare-up of COPD symptoms in the 2 years before starting triple therapy. Most patients had also received another therapy for COPD before starting triple therapy. A small proportion of patients started taking triple therapy after receiving no other therapy for COPD in the previous 2 years. The results of the study suggest that triple therapy for COPD in Germany is most often used in accordance with recommendations (patients already receiving therapy and experiencing repeated symptom flare-ups).

A network meta-analysis of the association between patient traits and response to regular dosing with ICS plus short-acting ß2-agonist reliever or ICS/formoterol reliever only in mild asthma.

INTRODUCTION/BACKGROUND: Mild asthma treatment recommendations include intermittent inhaled corticosteroid (ICS)/formoterol dosing or regular ICS dosing with short-acting ß2-agonist reliever. Due to the heterogeneity of asthma, identification of traits associated with improved outcomes to specific treatments would be clinically beneficial. AIMS/OBJECTIVES: To assess the impact of patient traits on treatment outcomes of regular ICS dosing compared with intermittent ICS/formoterol dosing, a systematic literature review (SLR) and network meta-analysis (NMA) was conducted. Searches identified randomised controlled trials (RCTs) of patients with asthma aged ≥12 years, containing ≥1 regular ICS dosing or intermittent ICS/formoterol dosing treatment arm, reporting traits and outcomes of interest. RESULTS: The SLR identified 11 RCTs of mild asthma, of 14,516 patients. A total of 11 traits and 11 outcomes of interest were identified. Of these, a feasibility assessment indicated possible assessment of three traits (age, baseline lung function, smoking history) and two outcomes (exacerbation rate, change in lung function). The NMA found no significant association of any trait with any outcome with regular ICS dosing relative to intermittent ICS/formoterol dosing. Inconsistent reporting of traits and outcomes between RCTs limited analysis. CONCLUSIONS: This is the first systematic analysis of associations between patient traits and differential treatment outcomes in mild asthma. Although the traits analysed were not found to significantly interact with relative treatment response, inconsistent reporting from the RCTs prevented assessment of some of the most clinically relevant traits and outcomes, such as adherence. More consistent reporting of respiratory RCTs would provide more comparable data and aid future analyses.

Real-world patient characteristics and treatment patterns in US patients with advanced non-small cell lung cancer.

BACKGROUND: Patients from non-small cell lung cancer (NSCLC) controlled clinical trials do not always reflect real-world heterogeneous patient populations. We designed a study to describe the real-world patient characteristics and treatment patterns of first-line treatment in patients in the US with NSCLC. METHODS: This was an observational, retrospective cohort study based on electronic medical records of US adults with locally advanced or metastatic disease in the ConcertAI Patient360 NSCLC database who initiated first-line treatment with anti-programmed cell death protein 1/programmed cell death ligand 1 (PD-1/PD-L1) therapy between July 2016 and December 2020. The analysis used patient attributes, clinical characteristics, and treatments from each patient's medical records. RESULTS: A total of 2175 patients were eligible for analysis. The median age was 68 years, and 26.2% of the patients were ≥75 years old. At treatment initiation, 96.4% and 3.6% of the patients had Stage 4 and Stage 3 (B or C) NSCLC, respectively. The most common histology type was nonsquamous adenocarcinoma (66.4%), and 19.8% had Eastern Cooperative Oncology Group performance status ≥2. Immunosuppressive medications were being used by 17.7% of patients, and 11.0% were immunocompromised. Almost all patients had metastases: 64.6% had 1, 23.2% had 2, and 8.0% had ≥3 metastatic sites. Brain metastases were present in 22.9% of patients. Treatment evolution was observed with first-line standard of care shifting from single-agent immunotherapy in 2016 (90.2%) to combination immunotherapy and chemotherapy in 2020 (60.2%). CONCLUSION: Between 2016 and 2020, the first-line treatment paradigm for advanced NSCLC in the US shifted from anti-PD-1/PD-L1 monotherapy to combination chemoimmunotherapy, with increasing biomarker testing. Further research in heterogeneous patient populations to characterize treatment strategies is warranted.

Heterogeneity in Measures of Illness among Patients with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Is Not Explained by Clinical Practice: A Study in Seven U.S. Specialty Clinics.

Background: One of the goals of the Multi-site Clinical Assessment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (MCAM) study was to evaluate whether clinicians experienced in diagnosing and caring for patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) recognized the same clinical entity. Methods: We enrolled participants from seven specialty clinics in the United States. We used baseline data (n = 465) on standardized questions measuring general clinical characteristics, functional impairment, post-exertional malaise, fatigue, sleep, neurocognitive/autonomic symptoms, pain, and other symptoms to evaluate whether patient characteristics differed by clinic. Results: We found few statistically significant and no clinically significant differences between clinics in their patients' standardized measures of ME/CFS symptoms and function. Strikingly, patients in each clinic sample and overall showed a wide distribution in all scores and measures. Conclusions: Illness heterogeneity may be an inherent feature of ME/CFS. Presenting research data in scatter plots or histograms will help clarify the challenge. Relying on case-control study designs without subgrouping or stratification of ME/CFS illness characteristics may limit the reproducibility of research findings and could obscure underlying mechanisms.