RESUMEN
While the coronavirus disease-2019 (COVID-19) might have increased acute episodes in people living with sickle cell disease (SCD), it may also have changed their reliance on emergency department (ED) services. We assessed the impact of the COVID-19 pandemic and lockdowns on ED visits in adult SCD people followed in five French reference centres, with a special focus on 'high users' (≥10 visits in 2019). We analysed the rate of ED visits from 1 January 2015 to 31 December 2021, using a self-controlled case series. Among 1530 people (17 829 ED visits), we observed a significant reduction in ED visits during and after lockdowns, but the effect vanished over time. Compared to pre-pandemic, incidence rate ratios for ED visits were 0.59 [95% CI 0.52-0.67] for the first lockdown, 0.66 [95% CI 0.58-0.75] for the second and 0.85 [95% CI 0.73-0.99] for the third. High users (4% of people but 33.7% of visits) mainly drove the reductions after the first lockdown. COVID-19 lockdowns were associated with reduced ED visits. While most people returned to their baseline utilization by April 2021, high users had a lasting decrease in ED visits. Understanding the factors driving the drop in ED utilization among high users might inform clinical practice and health policy.
Asunto(s)
Anemia de Células Falciformes , COVID-19 , Servicio de Urgencia en Hospital , SARS-CoV-2 , Humanos , COVID-19/epidemiología , Anemia de Células Falciformes/epidemiología , Anemia de Células Falciformes/terapia , Servicio de Urgencia en Hospital/estadística & datos numéricos , Masculino , Femenino , Adulto , Persona de Mediana Edad , Francia/epidemiología , Pandemias , Estudios de Cohortes , Adulto Joven , Adolescente , Aceptación de la Atención de Salud/estadística & datos numéricosRESUMEN
OBJECTIVES: During a drug overdose, research suggests individuals may not call 9-1-1 out of fear of criminal justice concerns. Of those that call, research is inconclusive about the disposition of the emergency transport. We evaluated transport outcomes for adults with opioid-related overdose in the Emergency Medical Services (EMS) of a large metropolitan city in the United States. METHODS: We reviewed the EMS incident report database from the patient care record system for years 2018 to 2022. We queried all records, searching for relevant terms, and two reviewers cross-checked the database to identify cases that did not result in death at the scene. Study outcome was defined as hospital transportation or no transportation. Multivariable logistic regression was used to estimate odds ratios (OR) and 95% confidence intervals (95% CI) for hospital transport with patient age, sex, race and ethnicity as the independent variables. RESULTS: We identified 5,482 cases of nonfatal opioid-related overdose. Of these, 4,984 (90.9%) were transported to the hospital; 37 (0.7%) were placed in police custody; 304 (5.5%) were not transferred; and 157 (2.9%) had unknown outcomes. Among 5,288 with data on the transport outcome, the majority were male (65%), and the highest proportion were White (39%). Compared to those who were not transported, each 1-year increase in age was related to a 2% increase in the odds of transportation (OR: 1.02, 95% CI: 1.01-1.02). Compared to White patients, Black and Hispanic patients were 43% OR: 1.43, 95% CI: 1.07-1.90) and 44% (OR: 1.44, 95% CI: 1.03-2.00) more likely to be transported. CONCLUSIONS: Individuals with suspected opioid-related overdose who call 9-1-1 are most often transported to the hospital. Current EMS procedures are successful at on-scene treatment and transportation; however, data on the long-term impact of opioid-related overdoses are still needed.
RESUMEN
Novel digital endpoints gathered via wearables, small devices, or algorithms hold great promise for clinical trials. However, implementation has been slow because of a lack of guidelines regarding the validation process of these new measurements. In this paper, we propose a pragmatic approach toward selection and fit-for-purpose validation of digital endpoints. Measurements should be value-based, meaning the measurements should directly measure or be associated with meaningful outcomes for patients. Devices should be assessed regarding technological validity. Most importantly, a rigorous clinical validation process should appraise the tolerability, difference between patients and controls, repeatability, detection of clinical events, and correlation with traditional endpoints. When technically and clinically fit-for-purpose, case building in interventional clinical trials starts to generate evidence regarding the response to new or existing health-care interventions. This process may lead to the digital endpoint replacing traditional endpoints, such as clinical rating scales or questionnaires in clinical trials. We recommend initiating more data-sharing collaborations to prevent unnecessary duplication of research and integration of value-based measurements in clinical care to enhance acceptance by health-care professionals. Finally, we invite researchers and regulators to adopt this approach to ensure a timely implementation of digital measurements and value-based thinking in clinical trial design and health care. SIGNIFICANCE STATEMENT: Novel digital endpoints are often cited as promising for the clinical trial of the future. However, clear validation guidelines are lacking in the literature. This paper contains pragmatic criteria for the selection, technical validation, and clinical validation of novel digital endpoints and provides recommendations for future work and collaboration.
Asunto(s)
Ensayos Clínicos como Asunto/métodos , Biomarcadores/análisis , Biomarcadores/metabolismo , Determinación de Punto Final/métodos , Humanos , Reproducibilidad de los ResultadosRESUMEN
Immune-related cutaneous adverse events (ircAE) are commonly seen with immune checkpoint inhibitors such as atezolizumab. Atezolizumab-induced psoriasis has been previously reported as an ircAE, especially in patients with pre-existing psoriasis. The severity of the reaction influences treatment of the cutaneous eruption. Biologics should be considered as a treatment option for severe refractory psoriasiform eruptions even in patients with complex medical conditions like chronic infections and malignancy. This is the first reported case of successful treatment of atezolizumab-induced psoriasiform eruption with ixekizumab, a neutralizing IL17A monoclonal antibody, to the best of our knowledge. Herein, we present a 63-year-old man with a history of human immunodeficiency virus and psoriasis who presented with atezolizumab-induced psoriasiform eruption while being treated for metastatic hepatocellular carcinoma. After initiating ixekizumab, atezolizumab was restarted without cutaneous eruption.
Asunto(s)
Erupciones por Medicamentos , Exantema , Psoriasis , Masculino , Humanos , Persona de Mediana Edad , Anticuerpos Monoclonales Humanizados/uso terapéutico , Psoriasis/tratamiento farmacológico , Erupciones por Medicamentos/etiología , Exantema/inducido químicamenteRESUMEN
We examined serum IGF-1 in premenopausal IOP, finding relationships that were opposite to those expected: higher IGF-1 was associated with lower bone formation and higher body fat, and lower BMD response to teriparatide. These paradoxical relationships between serum IGF-1, bone, and fat may contribute to the mechanism of idiopathic osteoporosis in premenopausal women. INTRODUCTION: Premenopausal women with idiopathic osteoporosis (IOP) have marked deficits in bone microarchitecture but variable bone remodeling. We previously reported that those with low tissue-level bone formation rate (BFR) are less responsive to teriparatide and have higher serum IGF-1, a hormone anabolic for osteoblasts and other tissues. The IGF-1 data were unexpected because IGF-1 is low in other forms of low turnover osteoporosis-leading us to hypothesize that IGF-1 relationships are paradoxical in IOP. This study aimed to determine whether IOP women with low BFR have higher IGF-1 and paradoxical IGF-1 relationships in skeletal and non-skeletal tissues, and whether IGF-1 and the related measures predict teriparatide response. METHODS: This research is an ancillary study to a 24 month clinical trial of teriparatide for IOP. Baseline assessments were related to trial outcomes: BMD, bone remodeling. SUBJECTS: Premenopausal women with IOP(n = 34); bone remodeling status was defined by baseline cancellous BFR/BS on bone biopsy. MEASURES: Serum IGF-1 parameters, compartmental adiposity (DXA, CT, MRI), serum hormones, and cardiovascular-risk-markers related to fat distribution. RESULTS: As seen in other populations, lower BFR was associated with higher body fat and poorer teriparatide response. However, in contrast to observations in other populations, low BFR, higher body fat, and poorer teriparatide response were all related to higher IGF-1: IGF-1 Z-score was inversely related to BFR at all bone surfaces (r = - 0.39 to - 0.46; p < 0.05), directly related to central fat (p = 0.05) and leptin (p = 0.03). IGF-1 inversely related to 24 month hip BMD %change (r = - 0.46; p = 0.01). CONCLUSIONS: Paradoxical IGF-1 relationships suggest that abnormal or atypical regulation of bone and fat may contribute to osteoporosis mechanisms in premenopausal IOP.
Asunto(s)
Conservadores de la Densidad Ósea , Osteoporosis , Tejido Adiposo , Densidad Ósea , Conservadores de la Densidad Ósea/uso terapéutico , Femenino , Humanos , Factor I del Crecimiento Similar a la Insulina , Osteogénesis , Osteoporosis/tratamiento farmacológico , Osteoporosis/etiología , Teriparatido/uso terapéuticoRESUMEN
Traditionally, the immune system is understood to be divided into discrete cell types that are identified via surface markers. While some cell type distinctions are no doubt discrete, others may in fact vary on a continum, and even within discrete types, differences in surface marker abundance could have functional implications. Here we propose a new way of looking at immune data, which is by looking directly at the values of the surface markers without dividing the cells into different subtypes. To assess the merit of this approach, we compared it with manual gating using cytometry data from the Singapore Longitudinal Aging Study (SLAS) database. We used two different neural networks (one for each method) to predict the presence of several health conditions. We found that the model built using raw surface marker abundance outperformed the manual gating one and we were able to identify some markers that contributed more to the predictions. This study is intended as a brief proof-of-concept and was not designed to predict health outcomes in an applied setting; nonetheless, it demonstrates that alternative methods to understand the structure of immune variation hold substantial progress.
RESUMEN
OBJECTIVES: An Israeli health maintenance organization (HMO) changed its policy from freedom of choice in choosing any primary care physician (PCP) to provide health care to one provider allocated to the patients. We examined outcome measures before and after the intervention in the study population. DESIGN: During a 2.5-year period (from June 2013 to December 2015), continuity of care by PCPs was achieved by a single provider. The change was computed for each participant according to the most visited PCP in the last year. PARTICIPANTS: A total of 208,286 patients aged 20 and older fulfilled the inclusion criteria. MAIN OUTCOME MEASURES: Future likelihood of hospitalization, number of PCP visits, and medication use before and after the intervention. RESULTS: After controlling for demographics, high continuity of care before and after intervention was associated with a lower likelihood of hospitalization for any condition (adjusted odds ratio [OR] = 0.90; 95% confidence interval [CI], 0.85-0.95; p = 0.003). No significant change was recorded for number of ambulatory visits or medication use. CONCLUSIONS: Changing Leumit HMO policy to continuity of care with a single provider is associated with a decreased future likelihood of hospitalization. This suggests that policies that encourage patients to concentrate their care with a single provider may lead to lower hospitalization rates and possibly lower healthcare costs.
Asunto(s)
Sistemas Prepagos de Salud , Médicos de Atención Primaria , Estudios de Cohortes , Hospitalización , Hospitales , Humanos , Israel/epidemiología , Atención Primaria de SaludRESUMEN
BACKGROUND: Low anterior resection syndrome (LARS) is a functional disorder that may follow restorative proctectomy. The aim of this study was to evaluate the long-term incidence and risk factors for LARS following surgery for rectal cancer. METHODS: A retrospective study was performed on patients from a prospectively maintained database, who underwent a restorative proctectomy between January 2014 and December 2019 at Hadassah Hebrew University Medical Center. The study cohort was divided into two groups: patients following partial proctectomy with a partial mesorectal excision and a colorectal anastomosis (PME group) and patients following total proctectomy with total mesorectal excision and a coloanal anastomosis (TME group). The incidence and severity of LARS were evaluated using the LARS questionnaire. Risk factors for LARS were also evaluated. RESULTS: A total of 240 patients (male: female ratio 134:106, median age 64 years [interquartile range 55-71 years]) were included in the analysis. There were 160 patients in the PME group and 80 patients in the TME group. The overall incidence of LARS was 37.4% (26.5% major LARS and 10.9% minor LARS). Major LARS was observed in 53.8% of patients who underwent TME and in 12.7% of patients who underwent PME (p < 0.001). On multivariate analysis, distance of the anastomosis from the anal verge, TME, and neoadjuvant radiotherapy were independent prognostic factors for LARS. The incidence and severity of LARS were significantly lower in patients with longer follow-up (p = 0.05). CONCLUSIONS: Significant improvement in LARS can be expected with longer follow-up. Distance of the anastomosis from the anal verge, TME and neoadjuvant radiotherapy are independent risk factors for LARS.
Asunto(s)
Enfermedades del Recto , Neoplasias del Recto , Humanos , Masculino , Femenino , Persona de Mediana Edad , Anciano , Neoplasias del Recto/cirugía , Neoplasias del Recto/complicaciones , Estudios de Seguimiento , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Estudios Retrospectivos , Incidencia , Síndrome , Recto/cirugía , Enfermedades del Recto/complicacionesRESUMEN
BACKGROUND: Due to high levels of stress, a practical course on stress management in medical school was offered to preclinical medical students at the Justus-Liebig University in Giessen up to 2019. In addition to autogenic training with specific resolution formulas, learning strategies, examination anxiety, and stress management were taught. OBJECTIVE: The aim was to determine the factors influencing the efficacy of the course as well as predictive factors favoring the success of preventive strategies for medical students. METHODS: A total of 81 medical students with an average age of Mâ¯= 25.4 years participated in this study, with 32.1% being male. The pre-post surveys were conducted anonymously with PSQ, BDI, PHQ9, HADS, SF-12 and the STQLS. RESULTS: With respect to satisfaction, stress, anxiety, and depression, a significant improvement was achieved at high effect levels (Cohen's dâ¯> 1). Initially, 35% of the students suffered from clinically relevant depression; these also showed a significantly higher stress level at the end of the course. This also applies to students with low study or life satisfaction. There were significant interactions of stress reduction depending on the existence of adequate learning techniques as well as anxiety symptoms but less often due to the existence of adequate stress management strategies. CONCLUSION: As predictive factors against a high stress level in medical students, a high study satisfaction and a high life satisfaction as well as low depression values could be confirmed. Relevant factors contributing to the efficacy of the course are learning strategies and coping with examination phobia. Theoretical information concerning stress management was found to be less helpful.
Asunto(s)
Estudiantes de Medicina , Adaptación Psicológica , Adulto , Ansiedad/diagnóstico , Ansiedad/terapia , Depresión/diagnóstico , Depresión/terapia , Femenino , Humanos , Masculino , Facultades de Medicina , Estrés Psicológico/diagnóstico , Estrés Psicológico/terapiaRESUMEN
In the published online PDF version, Figure 3 was incorrectly captured the same as Figure 1.
RESUMEN
PURPOSE: Fractal analysis can be used to quantitatively analyze the retinal microvasculature and might be a suitable method to quantify retinal capillary changes in sickle cell disease (SCD) patients. Retinal oximetry measurements might function as a proxy for the pathophysiology of cerebrovascular diseases. Moreover, hypoxia has an important role in the pathophysiology of diabetic and other retinopathies. However, little is known about the oximetry around the macula in SCD patients. With this study, we explored the feasibility to perform these quantified measurements in SCD patients. METHODS: Retinal microvascular and oximetry measurements were performed in eight SCD patients and eight healthy matched controls. Oximetry pictures and non-invasive capillary perfusion maps (nCPM) were obtained by the retinal function imager. Measurements were conducted twice on two different study days. Measured variables included monofractal dimension (Dbox), relative saturation, deoxygenated hemoglobin (deoxyHb), and oxygenated hemoglobin (oxyHb) concentration. RESULTS: No statistically significant differences in vessel density were found in the different annular zones (large vessels, p = 0.66; small vessels, p = 0.66) and anatomical quadrants (large vessels, p = 0.74; small vessels, p = 0.72). Furthermore, no significant between-group differences were found in the other different anatomical quadrants and annular zones around the fovea for relative saturation levels and deoxygenated Hb. However, the oxyHb levels were significantly lower in SCD patients, compared with those in matched controls in the temporal quadrants (p = 0.04; p = 0.02) and the superior nasal quadrant (p = 0.05). CONCLUSIONS: Our study demonstrated the feasibility of multispectral imaging to measure retinal changes in oxygenation in both SCD patients and matched volunteers. The results suggest that in SCD patients before any structural microvascular changes in the central retina are present, functional abnormalities can be observed with abnormal oximetry measurements.
Asunto(s)
Anemia de Células Falciformes/metabolismo , Oximetría/métodos , Consumo de Oxígeno/fisiología , Oxígeno/metabolismo , Enfermedades de la Retina/metabolismo , Adolescente , Adulto , Anemia de Células Falciformes/complicaciones , Anemia de Células Falciformes/diagnóstico , Capilares/patología , Femenino , Voluntarios Sanos , Humanos , Mácula Lútea/patología , Masculino , Microvasos/patología , Persona de Mediana Edad , Enfermedades de la Retina/diagnóstico , Enfermedades de la Retina/fisiopatología , Tomografía de Coherencia Óptica/métodos , Adulto JovenRESUMEN
BACKGROUND: Kidney cancer is a lethal neoplasm that affects several thousands of people every year. Renal cell carcinoma (RCC) is the most common histologic type. Recent developments in the therapeutic approach include antiangiogenic targeted approaches and Immunotherapy. Thus, the therapeutic algorithm of RCC patients and the survival outcomes have changed dramatically. METHODS: Herein we present a retrospective study of the patients treated in our Department with an antiangiogenic agent -Axitinib, a tyrosine kinase inhibitor- as a third or further line treatment. Statistical analysis was performed with SPSS, including the available clinicopathological data of the patients included. RESULTS: Axitinib was found to be active in patients who received this treatment beyond second line. The toxicity profile of this regimen did not reveal any unknown adverse events. CONCLUSIONS: Our real world data reflect that axitinib is a safe and effective option, even beyond the second line.
Asunto(s)
Axitinib/uso terapéutico , Carcinoma de Células Renales/tratamiento farmacológico , Neoplasias Renales/tratamiento farmacológico , Inhibidores de Proteínas Quinasas/uso terapéutico , Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios RetrospectivosRESUMEN
BACKGROUND: Coexistence of hidradenitis suppurativa (HS) and amyloidosis has been anecdotally described, but the association between these conditions is yet to be firmly established. AIM: To study the association between HS and amyloidosis using a large-scale computerized database, and to perform a literature review to characterize all reported patients with coexistent HS and amyloidosis. METHODS: A cross-sectional study was conducted comparing the prevalence of amyloidosis among patients with HS and age-, sex- and ethnicity-matched healthy controls (HCs). Additionally, a review of literature was performed to summarize all reported cases with a dual diagnosis of both conditions. RESULTS: In total, 4417 patients with HS and 22 085 controls were included in the study. The prevalence of amyloidosis was increased in patients with HS compared with the HC group [n = 7 (0.2%) vs. n = 2 (0.0%), respectively; OR = 17.5; 95% CI 3.6-84.4; P < 0.001]. In a multivariate analysis, HS was still associated with amyloidosis (OR = 11.2; 95% CI 1.3-94.5; P = 0.03). The literature review identified nine patients who developed amyloidosis during the course of HS, with 44.4% eventually having renal failure. â¬Favourable outcomes were reported in patients managed by tumour necrosis factor (TNF)-α inhibitors. CONCLUSION: This study establishes the association between HS and amyloidosis. Screening for amyloidosis may be considered in patients with HS with a relevant clinical picture, mainly proteinuria. TNF-α inhibitors may be preferred in patients with a dual diagnosis of these conditions.
Asunto(s)
Amiloidosis/complicaciones , Hidradenitis Supurativa/complicaciones , Adulto , Anciano , Estudios Transversales , Bases de Datos Factuales , Femenino , Humanos , Masculino , Persona de Mediana Edad , Análisis Multivariante , PrevalenciaRESUMEN
BACKGROUND: Hidradenitis suppurativa (HS) is a chronic, debilitating, dermatological disease that causes substantial psychosocial impediments with increased suicidal risk. Yet data on psychiatric comorbidity in HS have not been sufficiently elucidated in population-based studies. The current study sought to investigate the association between HS and schizophrenia, a major psychiatric disease, in a nationwide population-based study in Israel. METHODS: Data mining was performed on the database of Clalit Health Services (CHS), the largest managed healthcare company in Israel. Patients diagnosed with HS (n = 4191) were examined and compared to age- and sex-matched controls (n = 20 941). The association between HS and schizophrenia was assessed via multivariate binary logistic regression, adjusting for demographic factors and smoking status. RESULTS: The analysis revealed a tenfold increase in the prevalence of schizophrenia in HS patients compared to controls (1.4% and 0.4%, respectively, P < 0.001). In multivariate analysis, HS was found to be associated with schizophrenia (OR 1.44, 95% CI 1.01-2.07, P < 0.05). CONCLUSIONS: Hidradenitis suppurativa is associated with schizophrenia. Screening for severe mental illness during the assessment of patients with HS is of great importance, as comorbid psychiatric disorders may affect treatment outcomes.
Asunto(s)
Hidradenitis Supurativa/complicaciones , Esquizofrenia/complicaciones , Adulto , Estudios de Cohortes , Estudios Transversales , Femenino , Humanos , Israel , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Esquizofrenia/epidemiologíaRESUMEN
BACKGROUND: Current treatment paradigms in anti-p200 pemphigoid rely on low levels of evidence, primarily originating from case reports and case series. OBJECTIVE: To systematically review the utilized treatment modalities for anti-p200 pemphigoid and to synthesize the available clinical outcomes of treated patients. METHODS: We conducted a systematic review of the literature using Ovid-Medline (1946-2018), Embase (1947-2018) and Web of Science (1900-2018) databases with a broad and inclusive search strategy along with a subsequent search of retrieved articles. All case reports and case series of patients with anti-p200 pemphigoid were included. RESULTS: Sixty-eight eligible studies comprising 113 anti-p200 pemphigoid patients with a mean age of 65.5 years were included in the qualitative synthesis. The clinical outcome of patients following treatment was reported for 91 (80.5%) patients, of whom 83 (91.2%) had achieved complete remission at least once. Complete remission on-therapy was observed in 51 (56.0%) and complete remission off-therapy in 12 (13.2%) patients. Thirty-six (39.6%) patients had experienced at least one flare during the duration of follow-up. A combination of systemic corticosteroids and adjuvant immunomodulatory agents was the leading therapeutic approach (63.0%) required for disease control. Systemic and topical corticosteroids as monotherapy were sufficient to control the disease in 19.6% and 13.0% of cases, respectively. Dapsone was the most commonly used (41.3%) adjuvant agent. The highest rates of complete remission were achieved in patients managed by systemic corticosteroids as monotherapy (100%) and in those managed by systemic corticosteroids with adjuvant agents (90.7%). Conversely, 45.5% of patients treated only by topical corticosteroids experienced at least one relapse during follow-up. CONCLUSION: The vast majority of patients had reached a complete remission during the course of the disease, whereas a considerable proportion of patients experienced at least one relapse. A combination of systemic corticosteroids and adjuvant immunomodulatory agents was the most frequently utilized therapeutic approach.
Asunto(s)
Antígenos de Neoplasias/inmunología , Autoanticuerpos/inmunología , Penfigoide Ampolloso/tratamiento farmacológico , Penfigoide Ampolloso/inmunología , Humanos , Inducción de Remisión , Resultado del TratamientoRESUMEN
BACKGROUND: Drug survival rates in patients with psoriasis had been described extensively. Different survival rates of TNF-α inhibitors (TNFIs), ustekinumab and secukinumab were reported. OBJECTIVES: To investigate drug survival rates of TNFIs, ustekinumab and secukinumab, with particular emphasis on the difference between ustekinumab and secukinumab. METHODS: Survival analysis was performed in patients with moderate-to-severe psoriasis who received adalimumab, infliximab, etanercept, ustekinumab and secukinumab treatment in 2002-2018, using the Clalit Health Services database. Stratified analysis was performed according to biologic treatment lines. Multivariate analysis was performed adjusting for demographic variables, calendar year, metabolic syndrome, psoriatic arthritis, biologic treatment line, biologic naivety, co-administration of oral treatments and previous oral systemic treatment exposure. RESULTS: Among 1459 patients treated with 3070 biologic medication courses, ustekinumab had a significantly higher crude survival as compared with TNFIs and secukinumab. The mean drug survival of ustekinumab, adalimumab, etanercept, infliximab and secukinumab was 43.5 (CI: 39.7-47.2), 38.2 (CI: 34.8-41), 33.9 (CI: 30.8-37.1), 28.2 (CI: 22.5-33.8) and 17.1 (CI: 15.6-18.6) months, respectively, with significant statistical differences for all comparisons (P < 0.001). The differences between ustekinumab and secukinumab were not significant following adjustment to factors that included treatment line (hazard rate 1.16, CI: 0.93-1.43). CONCLUSION: Different drug survival rates between ustekinumab and secukinumab are determined by the treatment line and calendar year, reflecting the availability of biologic medications, and not only by the biologic attributes of each medication.
Asunto(s)
Productos Biológicos , Preparaciones Farmacéuticas , Psoriasis , Adalimumab , Productos Biológicos/uso terapéutico , Etanercept , Humanos , Infliximab , Psoriasis/tratamiento farmacológico , Ustekinumab/uso terapéuticoRESUMEN
BACKGROUND: Assessment of treatment effects in clinical trials requires valid information on treatment adherence, adverse events and symptoms. Paper-based diaries are often inconvenient and have limited reliability, particularly for outpatient trials. OBJECTIVES: To investigate the utility of an electronic diary (e-diary) application for patients with skin diseases in outpatient clinical trials. METHODS: An e-diary application was developed and technically validated. Treatment adherence was defined as topical administration by the patient, and patient-reported outcomes, i.e. pain and itch, were evaluated by the e-diary in six clinical trials on newly tested topical drugs. Additionally, the proportion of patients capturing the applied topical drug by camera and filling in the pain and itch scores was defined as e-diary adherence, and patients' perception of usefulness and acceptability of the e-diary were evaluated. RESULTS: Treatment adherence rates of the included 256 patients were high (median 98%, range 97-99%). E-diary adherence was also high with a median of 93% (range 87-97%) for capturing the applied drug by camera, and 89% (range 87-96%) and 94% (range 87-96%) for entering respectively the itch and pain score. Daily symptom scores provided good insights into the disease burden, and patients rated the e-diary as good to excellent with respect to user acceptability. CONCLUSIONS: The results suggest that the e-diary is an excellent way to ensure proper treatment administration, indicated by both the high user acceptability scores and high treatment adherence. Moreover, the e-diary may also be valuable for frequent and reliable monitoring of patient-reported outcomes in daily clinical practice.
Asunto(s)
Ensayos Clínicos como Asunto/normas , Diarios como Asunto , Aplicaciones Móviles , Medición de Resultados Informados por el Paciente , Enfermedades de la Piel/tratamiento farmacológico , Cumplimiento y Adherencia al Tratamiento , Adolescente , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Adulto JovenRESUMEN
BACKGROUND: Portable gluten sensors are now commercially available to the public, although there is genuine uncertainty within the medical community over whether they should be used for coeliac disease management. The present study described qualitatively the experience of using a portable gluten sensor for 15 adults and 15 adolescents with coeliac disease participating in a 3-month pilot clinical trial. METHODS: Participants were 30 individuals, aged 13-70 years, with biopsy-confirmed coeliac disease on a gluten-free diet. All received a portable gluten sensor and were randomised to low, medium, and high numbers of single-use capsules. Open-ended questions addressed likes and dislikes using the portable gluten sensor after 3 months. Major themes were identified and described. RESULTS: Participants liked that the portable gluten sensor provided extra assurance to check foods presented as gluten-free, the convenient size and portability, the added sense of control, and overall peace-of-mind. Participants disliked having attention drawn to them when using the sensor and feeling as if they were deterring others from eating. Participants also disliked the physical difficulty associated with using the capsules, questionable accuracy and the inability to test fermented foods. Adults were more enthusiastic about the sensor than adolescents. CONCLUSIONS: Positive and negative experiences may be expected when using commercially available portable gluten sensors to help manage coeliac disease. As future versions of this and other gluten sensors become available, it will be important to investigate the relationship between users' experience with the sensors and long-term outcomes such as mucosal healing and quality of life.
Asunto(s)
Enfermedad Celíaca/psicología , Dieta Sin Gluten/instrumentación , Dieta Sin Gluten/psicología , Análisis de los Alimentos/instrumentación , Aceptación de la Atención de Salud/psicología , Adolescente , Adulto , Anciano , Enfermedad Celíaca/dietoterapia , Emociones , Conducta Alimentaria/psicología , Femenino , Glútenes/análisis , Humanos , Masculino , Persona de Mediana Edad , Proyectos Piloto , Investigación Cualitativa , Calidad de Vida , Adulto JovenRESUMEN
BACKGROUND: Chronic urticaria (CU) carries many risk factors for osteoporosis, but data on the relationships between CU and osteoporosis are lacking. OBJECTIVES: To evaluate the association between CU and osteoporosis in a large community-based study. METHODS: A nationwide observational longitudinal cohort study was conducted. CU was defined as four pairs of urticaria diagnoses; each pair was recorded within a period of 6 weeks and was registered by physicians in a primary-care setting. Patients with CU and their age- and sex- matched controls were followed for the incidence of osteoporosis and other laboratory data between 2002 and 2017. Data regarding systemic steroid exposure and other relevant risk factors for osteoporosis were obtained. Analyses of risk for osteoporosis were performed in Cox regression models adjusted for age, sex, exposure to systemic corticosteroids, obesity, smoking and hyper- and hypothyroid disease. RESULTS: The study included 11 944 patients with CU and 59 829 controls. During the study's observation period, 1035 (8·7%) patients with CU were diagnosed with osteoporosis, compared with 4046 (6·8%) controls. The adjusted multivariate analysis demonstrated that CU was significantly associated with a higher risk for osteoporosis (hazard ratio 1·23, 95% confidence interval 1·10-1·37, P < 0·001). CONCLUSIONS: CU may impose a risk for osteoporosis. Appropriate targeted screening should be considered.
Asunto(s)
Urticaria Crónica/complicaciones , Osteoporosis/epidemiología , Adolescente , Adulto , Estudios de Casos y Controles , Femenino , Humanos , Incidencia , Israel/epidemiología , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Osteoporosis/etiología , Factores de Riesgo , Adulto JovenRESUMEN
BACKGROUND: Numerous studies have indicated that comorbid anxiety and depression are associated with a more severe course of illness. Yet generally, the study of the effect of psoriasis on patients' mental health has considered anxiety and depression to be separate states. OBJECTIVE: To measure the association between psoriasis and anxiety, depression and anxiety-depression co-occurrence among patients according to their socioeconomic statuses (SES). METHODS: A nationwide population-based study of psoriasis patients and age and gender frequency-matched controls (n = 255 862) was designed. Diagnostic data were obtained from Clalit Health Services, the largest managed care organization in Israel. This database was established using continuous real-time input from healthcare providers, pharmacies, medical care facilities and administrative computerized operating systems. RESULTS: After controlling for demographic and clinical variables, psoriasis was associated with anxiety (OR 1.11, 95% CI 1.01-1.23, P < 0.05), depression (OR 1.17, 95% CI 1.08-1.26, P < 0.001), and anxiety and depression co-occurrence (OR 1.32, 95% CI 1.21-1.45, P < 0.001) among patients with low SES, yet was associated only with anxiety (OR 1.15 95% CI 1.04-1.27, P < 0.001) but not depression or comorbid anxiety-depression among patients with high SES. Survival analyses indicated that between the ages of 40 and 60, the cumulative probability of psoriasis patients with low SES to suffer from anxiety, depression and their co-occurrence inclined more sharply with age as compared to psoriasis patients with high SES. CONCLUSIONS: As psoriasis patients with low SES are prone to suffer from more severe courses of anxiety and depression, the choice of treatment of psoriasis should address the SES as well as the underlying psychiatric disease.