RESUMEN
BACKGROUND: This study was an ex-ante cost-utility analysis of deemed consent legislation for deceased organ donation in Nova Scotia, a province in Canada. The legislation became effective in January 2021. The study's objective was to assess the conditions necessary for the legislation change's cost-effectiveness compared to expressed consent, focusing on kidney transplantation (KT). METHOD: We performed a cost-utility analysis using a Markov model with a lifetime horizon. The study was from a Canadian payer perspective. The target population was patients with end-stage kidney disease (ESKD) in Atlantic Canada waitlisted for KT. The intervention was the deemed consent and accompanying health system transformations. Expressed consent (before the change) was the comparator. We simulated the minimum required increase in deceased donor KT per year for the cost-effectiveness of the deemed consent. We also evaluated how changes in dialysis and maintenance immunosuppressant drug costs and living donor KT per year impacted cost-effectiveness in sensitivity analyses. RESULTS: The expected lifetime cost of an ESKD patient ranged from $177,663 to $553,897. In the deemed consent environment, the expected lifetime cost per patient depended on the percentage increases in the proportion of ESKD patients on the waitlist getting a KT in a year. The incremental cost-utility ratio (ICUR) increased with deceased donor KT per year. Cost-effectiveness of deemed consent compared to expressed consent required a minimum of a 1% increase in deceased donor KT per year. A 1% increase was associated with an ICUR of $32,629 per QALY (95% CI: - $64,279, $232,488) with a 81% probability of being cost-effective if the willingness-to-pay (WTP) was $61,466. Increases in dialysis and post-KT maintenance immunosuppressant drug costs above a threshold impacted value for money. The threshold for immunosuppressant drug costs also depended on the percent increases in deceased donor KT probability and the WTP threshold. CONCLUSIONS: The deemed consent legislation in NS for deceased organ donation and the accompanying health system transformations are cost-effective to the extent that they are anticipated to contribute to more deceased donor KTs than before, and even a small increase in the proportion of waitlist patients receiving a deceased donor KT than before the change represents value for money.
RESUMEN
BACKGROUND: Kidney transplantation (KT) is often reported in the literature as associated with cost savings. However, existing studies differ in their choice of comparator, follow-up period, and the study perspective. Also, there may be unobservable heterogeneity in health care costs in the patient population which may divide the population into groups with differences in cost distributions. This study estimates the cost savings associated with KT from a payer perspective and identifies and characterizes both high and low patient cost groups. METHOD: The current study was a population-based retrospective before-and-after study. The timespan involved at most three years before and after KT. The sample included end-stage kidney disease patients in Nova Scotia, a province in Canada, who had a single KT between January 1, 2011, and December 31, 2018. Each patient served as their control. The primary outcome measure was total annual health care costs. We estimated cost savings using unadjusted and adjusted models, stratifying the analyses by donor type. We quantified the uncertainty around the estimates using non-parametric and parametric bootstrapping. We also used finite mixture models to identify data-driven cost groups based on patients' pre-transplantation annual inpatient costs. RESULTS: The mean annual cost savings per patient associated with KT was $19,589 (95% CI: $14,013, $23,397). KT was associated with a 24-29% decrease in mean annual health care costs per patient compared with the annual costs before KT. We identified and characterized patients in three cost groups made of 2.9% in low-cost (LC), 51.8% in medium-cost (MC) and 45.3% in high-cost (HC). Cost group membership did not change after KT. Comparing costs in each group before and after KT, we found that KT was associated with 17% mean annual cost reductions for the LC group, 24% for the MC group and 26% for the HC group. The HC group included patients more likely to have a higher comorbidity burden (Charlson comorbidity index ≥ 3). CONCLUSIONS: KT was associated with reductions in annual health care costs in the short term, even after accounting for costs incurred during KT.
RESUMEN
BACKGROUND: Clinical trials and meta-analyses have suggested that aspirin may be effective for the prevention of venous thromboembolism (proximal deep-vein thrombosis or pulmonary embolism) after total hip or total knee arthroplasty, but comparisons with direct oral anticoagulants are lacking for prophylaxis beyond hospital discharge. METHODS: We performed a multicenter, double-blind, randomized, controlled trial involving patients who were undergoing total hip or knee arthroplasty. All the patients received once-daily oral rivaroxaban (10 mg) until postoperative day 5 and then were randomly assigned to continue rivaroxaban or switch to aspirin (81 mg daily) for an additional 9 days after total knee arthroplasty or for 30 days after total hip arthroplasty. Patients were followed for 90 days for symptomatic venous thromboembolism (the primary effectiveness outcome) and bleeding complications, including major or clinically relevant nonmajor bleeding (the primary safety outcome). RESULTS: A total of 3424 patients (1804 undergoing total hip arthroplasty and 1620 undergoing total knee arthroplasty) were enrolled in the trial. Venous thromboembolism occurred in 11 of 1707 patients (0.64%) in the aspirin group and in 12 of 1717 patients (0.70%) in the rivaroxaban group (difference, 0.06 percentage points; 95% confidence interval [CI], -0.55 to 0.66; P<0.001 for noninferiority and P=0.84 for superiority). Major bleeding complications occurred in 8 patients (0.47%) in the aspirin group and in 5 (0.29%) in the rivaroxaban group (difference, 0.18 percentage points; 95% CI, -0.65 to 0.29; P=0.42). Clinically important bleeding occurred in 22 patients (1.29%) in the aspirin group and in 17 (0.99%) in the rivaroxaban group (difference, 0.30 percentage points; 95% CI, -1.07 to 0.47; P=0.43). CONCLUSIONS: Among patients who received 5 days of rivaroxaban prophylaxis after total hip or total knee arthroplasty, extended prophylaxis with aspirin was not significantly different from rivaroxaban in the prevention of symptomatic venous thromboembolism. (Funded by the Canadian Institutes of Health Research; ClinicalTrials.gov number, NCT01720108 .).
Asunto(s)
Artroplastia de Reemplazo de Cadera , Artroplastia de Reemplazo de Rodilla , Aspirina/uso terapéutico , Inhibidores del Factor Xa/uso terapéutico , Inhibidores de Agregación Plaquetaria/uso terapéutico , Complicaciones Posoperatorias/prevención & control , Rivaroxabán/uso terapéutico , Tromboembolia Venosa/prevención & control , Anciano , Aspirina/efectos adversos , Método Doble Ciego , Inhibidores del Factor Xa/efectos adversos , Hemorragia/inducido químicamente , Humanos , Masculino , Persona de Mediana Edad , Inhibidores de Agregación Plaquetaria/efectos adversos , Factores de Riesgo , Rivaroxabán/efectos adversosRESUMEN
BACKGROUND: Patient-prosthesis mismatch (PPM) has been identified as a risk factor for mortality and reoperation in patients undergoing surgical aortic valve replacement (SAVR). We present a retrospective analysis of risk factors for PPM and the effects of PPM on early postoperative outcomes after SAVR. METHODS: Chart review was conducted for patients (N = 3003) undergoing SAVR. PPM was calculated from valve reference orifice areas and patient body surface area. Logistic regression was used to analyze risk factors for PPM and develop a risk score from these results. Regression was also conducted to identify associations between projected PPM status and postoperative outcomes. RESULTS: Risk factors for PPM included female sex, higher body mass index (BMI), and use of the St. Jude Epic valve. Patients receiving St. Jude trifecta valves or mechanical valves were less likely to have predicted PPM. We developed a risk score using BMI, sex, and valve type, and retrospectively predicted PPM in our cohort. Mild PPM (odds ratio [OR] = 2.267), severe PPM (OR = 2.869), male sex (OR = 2.091), and younger age (OR = 0.940) were all predictors of SAVR reoperation, while aortic root replacement was associated with reduced reoperation rates (OR = 0.122). Severe PPM carried a risk of in-hospital mortality (OR = 3.599), and moderate PPM carried a smaller but significant risk (OR = 1.920). Other factors increasing postoperative morbidity and mortality included older age, renal failure, and diabetes. CONCLUSION: PPM could be retrospectively predicted in our cohort using a risk calculation from sex, BMI and valve type. We conclude that all degrees of PPM carry risk for mortality and reoperation.
Asunto(s)
Estenosis de la Válvula Aórtica , Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Anciano , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/cirugía , Femenino , Humanos , Masculino , Complicaciones Posoperatorias/epidemiología , Diseño de Prótesis , Estudios Retrospectivos , Factores de Riesgo , Resultado del TratamientoRESUMEN
BACKGROUND: The Carpentier-Edwards Perimount valves have a proven track record in aortic valve replacement: good durability, hemodynamic performance, rates of survival, and low rates of valve-related complications and prosthesis-patient mismatch. The St. Jude Medical Trifecta is a newer valve that has shown comparable early and midterm outcomes. Studies show reoperation rates of Trifecta are comparable with Perimount valves, with a few recent studies bringing into focus early structural valve deterioration (SVD), and increased midterm SVD in younger patients. Given that midterm data for Trifecta is still sparse, we wanted to confirm the early low reoperation rates of Trifecta persist over time compared with Perimount. METHODS: The Maritime Heart Centre Database was searched for AVR between 2011 and 2016, inclusive. The primary endpoint of the study was all-cause reoperation rate. RESULTS: In total, 711 Perimount and 453 Trifecta implantations were included. The reoperation hazards were determined for age: 0.96 (0.92-0.99; p = .02), female (vs. male): 0.35 (0.08-1.53; p = .16), smoker (vs. nonsmoker): 2.44 (0.85-7.02; p = .1), and Trifecta (vs. Perimount): 2.68 (0.97-7.39; p = .06). Kaplan-Meier survival analysis in subgroups-age <60, age ≥60, male, female, smoker, and nonsmoker-showed Perimount having lower reoperation rates than Trifecta in patients younger than 60 (p = .02) and current smokers (p < .01). CONCLUSIONS: The rates of reoperation of Perimount and Trifecta were comparable, with Trifecta showing higher rates in patients younger than 60 years, and current smokers. Continued diligence and further independent reporting of midterm reoperation and SVD rates of the Trifecta, including detailed echocardiographic follow-up, are needed to confirm these findings.
Asunto(s)
Bioprótesis , Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Válvula Aórtica/cirugía , Femenino , Estudios de Seguimiento , Hemodinámica , Humanos , Lactante , Masculino , Diseño de Prótesis , Reoperación , Estudios RetrospectivosRESUMEN
BACKGROUND: Phlebotomy for diagnostic testing is among the commonest hospital procedures, but hospital-wide surveys of all inpatients characterizing blood draw volumes have not been published. The objectives were to characterize the daily blood volumes drawn for diagnostic testing from patients discharged from a Canadian tertiary care center, describe the daily distributions of phlebotomy volumes across service locations, and describe changes in hemoglobin (Hb) and transfusion across service locations. STUDY DESIGN AND METHODS: Data were obtained on all patients discharged between 2012 and 2014 using linked discharge abstract and laboratory data. Cumulative daily blood volume and draw frequency were reported by service and days since admission. Changes in Hb and red blood cell (RBC) transfusion rates were reported for nontransfused and transfused patients. RESULTS: Data were included on 59,715 subjects. Mean daily estimated blood loss varied from 8.5 ± 6.5 mL/day onward to 27.2 ± 20.0 mL/day in the intensive care unit (ICU; p < 0.001). Phlebotomy volumes were highest on the first day of admission and declined thereafter (p < 0.001). For nontransfused individuals in the first week of admission, Hb levels decreased by the highest percentage in the ICU. The rate of RBC unit transfusion was highest in the ICU (232.4 units/1000 patient-days; 95% confidence interval, 225.8-239.2; p < 0.0001 compared with all other locations). CONCLUSION: Considerable variation was observed in estimated blood loss due to diagnostic phlebotomy across different services within one teaching hospital. Thi information is foundational for planning interventions to minimize estimated blood loss from phlebotomy.
Asunto(s)
Volumen Sanguíneo , Pruebas Diagnósticas de Rutina/métodos , Pruebas Diagnósticas de Rutina/estadística & datos numéricos , Flebotomía/métodos , Flebotomía/estadística & datos numéricos , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Anemia/sangre , Anemia/epidemiología , Transfusión Sanguínea/estadística & datos numéricos , Volumen Sanguíneo/fisiología , Canadá/epidemiología , Censos , Pruebas Diagnósticas de Rutina/tendencias , Femenino , Hospitalización/estadística & datos numéricos , Humanos , Pacientes Internos/estadística & datos numéricos , Unidades de Cuidados Intensivos/estadística & datos numéricos , Masculino , Persona de Mediana Edad , Flebotomía/tendencias , Pautas de la Práctica en Enfermería/estadística & datos numéricos , Centros de Atención Terciaria/estadística & datos numéricos , Adulto JovenRESUMEN
OBJECTIVE: To test the hypothesis that caregivers enhance the wheelchair skills capacity and confidence of the power wheelchair users to whom they provide assistance, and to describe the nature of that assistance. DESIGN: Multicenter cross-sectional study. SETTING: Rehabilitation centers and communities. PARTICIPANTS: Participants (N=152) included caregivers (n=76) and wheelchair users (n=76). INTERVENTIONS: None. MAIN OUTCOME MEASURES: Version 4.3 of the Wheelchair Skills Test (WST) and the Wheelchair Skills Test-Questionnaire (WST-Q). For each of the 30 individual skills, we recorded data about the wheelchair user alone and in combination (blended) with the caregiver. RESULTS: The mean total WST capacity scores ± SD for the wheelchair users alone and blended were 78.1%±9.3% and 92.4%±6.1%, respectively, with a mean difference of 14.3%±8.7% (P<.0001). The mean WST-Q capacity scores ± SD were 77.0%±10.6% and 93.2%±6.4%, respectively, with a mean difference of 16.3%±9.8% (P<.0001). The mean WST-Q confidence scores ± SD were 75.5%±12.7% and 92.8%±6.8%, respectively, with a mean difference of 17.5%±11.7% (P<.0001). The mean differences corresponded to relative improvements of 18.3%, 21.0%, and 22.9%, respectively. The nature and benefits of the caregivers' assistance could be summarized in 7 themes (eg, caregiver provides verbal support [cueing, coaching, reporting about the environment]). CONCLUSIONS: Caregivers significantly enhance the wheelchair skills capacity and confidence of the power wheelchair users to whom they provide assistance, and they do so in a variety of ways. These findings have significance for wheelchair skills assessment and training.
Asunto(s)
Cuidadores/psicología , Personas con Discapacidad/psicología , Autoimagen , Silla de Ruedas/psicología , Anciano , Anciano de 80 o más Años , Estudios Transversales , Femenino , Humanos , Masculino , Persona de Mediana Edad , Centros de Rehabilitación , Encuestas y CuestionariosRESUMEN
OBJECTIVES: To (1) document the success of learners' attempts to overcome a threshold in a manual wheelchair while using the momentum method; (2) describe the frequency and nature of any errors observed; and (3) compare the characteristics of participants who were or were not successful on their first attempts. DESIGN: Cross-sectional, observational study following Strengthening the Reporting of Observational Studies in Epidemiology guidelines. SETTING: Indoor obstacle course in a rehabilitation center. PARTICIPANTS: Able-bodied students (N=214) learning the threshold skill. INTERVENTION: Participants attempted to get over the Wheelchair Skills Test (WST) threshold (2cm high, 1.5m wide, and 10cm in the line of progression) in a manual wheelchair. MAIN OUTCOME MEASURES: From each participant's video recording of the first attempt, we assigned a WST score for the skill and described any errors noted. RESULTS: The WST scores for the first attempts were "pass" for 16 (7.5%), "pass with difficulty" for 100 (46.7%), and "fail" for 98 (45.8%). Eventually, requiring up to 6 attempts, 203 participants (94.9%) were successful (pass or pass with difficulty). Twenty-six different error types were identified. With the use of logistic regression analysis, the odds ratio of failing on the first attempt for women versus men was 2.71 (95% confidence interval, 1.23-6.00) (P=.0138). CONCLUSIONS: Only about half of able-bodied people learning the threshold skill using the momentum method are successful on their first attempts, although almost all are successful with further practice and feedback. During the first attempts, there are a wide variety of errors, primarily in the popping phase of the skill. Those who are successful on their first attempts are more likely to be men. These findings have implications for the assessment and training of the threshold skill.
Asunto(s)
Personas con Discapacidad/rehabilitación , Curva de Aprendizaje , Silla de Ruedas , Estudios Transversales , Femenino , Humanos , Masculino , Centros de RehabilitaciónRESUMEN
OBJECTIVE: To determine nephritis outcomes in a prospective multi-ethnic/racial SLE inception cohort. METHODS: Patients in the Systemic Lupus International Collaborating Clinics inception cohort (≤15 months of SLE diagnosis) were assessed annually for estimated glomerular filtration rate (eGFR), proteinuria and end-stage renal disease (ESRD). Health-related quality of life was measured by the Short Form (36 questions) health survey questionnaire (SF-36) subscales, mental and physical component summary scores. RESULTS: There were 1827 patients, 89% females, mean (s.d.) age 35.1 (13.3) years. The mean (s.d.) SLE duration at enrolment was 0.5 (0.3) years and follow-up 4.6 (3.4) years. LN occurred in 700 (38.3%) patients: 566/700 (80.9%) at enrolment and 134/700 (19.1%) during follow-up. Patients with nephritis were younger, more frequently men and of African, Asian and Hispanic race/ethnicity. The estimated overall 10-year incidence of ESRD was 4.3% (95% CI: 2.8%, 5.8%), and with nephritis was 10.1% (95% CI: 6.6%, 13.6%). Patients with nephritis had a higher risk of death (HR = 2.98, 95% CI: 1.48, 5.99; P = 0.002) and those with eGFR <30 ml/min at diagnosis had lower SF-36 physical component summary scores (P < 0.01) and lower Physical function, Physical role and Bodily pain scores. Over time, patients with abnormal eGFR and proteinuria had lower SF-36 mental component summary (P ≤ 0.02) scores compared to patients with normal values. CONCLUSION: LN occurred in 38.3% of SLE patients, frequently as the initial presentation, in a large multi-ethnic inception cohort. Despite current standard of care, nephritis was associated with ESRD and death, and renal insufficiency was linked to lower health-related quality of life. Further advances are required for the optimal treatment of LN.
Asunto(s)
Etnicidad , Nefritis Lúpica/etnología , Evaluación de Resultado en la Atención de Salud , Adulto , Progresión de la Enfermedad , Femenino , Estudios de Seguimiento , Salud Global , Humanos , Incidencia , Nefritis Lúpica/diagnóstico , Masculino , Estudios Prospectivos , Calidad de Vida , Factores de Riesgo , Encuestas y Cuestionarios , Tasa de Supervivencia/tendenciasRESUMEN
BACKGROUND: Sellar masses (SM) are mostly benign growths of pituitary or nonpituitary origin that are increasingly encountered in clinical practice. To date, no comprehensive population-based study has reported the epidemiology of SM from North America. AIM: To determine the epidemiology of SM in the province of Nova Scotia, Canada. METHODS: Data from all pituitary-related referrals within the province were prospectively collected in interlinked computerized registries starting in November 2005. We conducted a retrospective analysis on all patients with SM seen within the province between November 2005 and December 2013. RESULTS: A total of 1107 patients were identified, of which 1005 were alive and residing within the province. The mean age at presentation was 44.6±18 years, with an overall female preponderance (62%) and a population prevalence rate of 0.1%. Of patients with SM, 837 (83%) had pituitary adenomas and 168 (17%) had nonpituitary lesions. The relative prevalence and standardized incidence ratio, respectively, of various SM were: nonfunctioning adenomas (38.4%; 2.34), prolactinomas (34.3%; 2.22), Rathke's cyst (6.5%; 0.5), growth hormone-secreting adenomas (6.5%; 0.3), craniopharyngiomas (4.5%; 0.2), adrenocorticotropic hormone-secreting adenomas (3.8%; 0.2), meningiomas (1.9%), and others (3.9%; 0.21). At presentation, 526 (52.3%) had masses ≥1 cm, 318 (31.6%) at <1 cm, and 11 (1.1%) had functioning pituitary adenomas without discernible tumor, whereas tumor size data were unavailable in 150 (14.9%) patients. The specific pathologies and their most common presenting features were: nonfunctioning adenoma (incidental, headaches, and vision loss), prolactinomas (galactorrhea, menstrual irregularity, and headache), growth hormone-secreting adenomas (enlarging extremities and sweating), adrenocorticotropic hormone-secreting adenoma (easy bruising, muscle wasting, and weight gain) and nonpituitary lesions (incidental, headaches, and vision problems). Secondary hormonal deficiencies were common, ranging from 19.6% to 65.7%; secondary hypogonadism, hypothyroidism, and growth hormone deficiencies constituted the majority of these abnormalities. CONCLUSIONS: This is the largest North American study to date to assess the epidemiology of SM in a large stable population. Given their significant prevalence in the general population, more studies are needed to evaluate the natural history of these masses and to help allocate appropriate resources for their management.
Asunto(s)
Neoplasias Hipofisarias/epidemiología , Adulto , Femenino , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Nueva Escocia/epidemiología , Prevalencia , Sistema de RegistrosRESUMEN
OBJECTIVES: To test the hypothesis that powered wheelchair users who receive the Wheelchair Skills Training Program (WSTP) improve their wheelchair skills in comparison with a control group that receives standard care, and secondarily to assess goal achievement, satisfaction with training, retention, injury rate, confidence with wheelchair use, and participation. DESIGN: Randomized controlled trial. SETTING: Rehabilitation centers and communities. PARTICIPANTS: Powered wheelchair users (N=116). INTERVENTION: Five 30-minute WSTP training sessions. MAIN OUTCOME MEASURES: Assessments were done at baseline (t1), posttraining (t2), and 3 months posttraining (t3) using the Wheelchair Skills Test Questionnaire (WST-Q version 4.1), Goal Attainment Score (GAS), Satisfaction Questionnaire, injury rate, Wheelchair Use Confidence Scale for Power Wheelchair Users (WheelCon), and Life Space Assessment (LSA). RESULTS: There was no significant t2-t1 difference between the groups for WST-Q capacity scores (P=.600), but the difference for WST-Q performance scores was significant (P=.016) with a relative (t2/t1 × 100%) improvement of the median score for the intervention group of 10.8%. The mean GAS ± SD for the intervention group after training was 92.8%±11.4%, and satisfaction with training was high. The WST-Q gain was not retained at t3. There was no clinically significant difference between the groups in injury rate and no statistically significant differences in WheelCon or LSA scores at t3. CONCLUSIONS: Powered wheelchair users who receive formal wheelchair skills training demonstrate modest, transient posttraining improvements in their WST-Q performance scores, have substantial improvements on individualized goals, and are positive about training.
Asunto(s)
Personas con Discapacidad/rehabilitación , Educación del Paciente como Asunto/organización & administración , Centros de Rehabilitación , Silla de Ruedas , Adulto , Anciano , Suministros de Energía Eléctrica , Femenino , Objetivos , Humanos , Masculino , Persona de Mediana Edad , Satisfacción del Paciente , Método Simple CiegoRESUMEN
OBJECTIVE: To examine the frequency and characteristics of headaches and their association with global disease activity and health-related quality of life (HRQOL) in patients with systemic lupus erythematosus (SLE). METHODS: A disease inception cohort was assessed annually for headache (5 types) and 18 other neuropsychiatric (NP) events. Global disease activity scores (SLE Disease Activity Index 2000 [SLEDAI-2K]), damage scores (Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index [SDI]), and Short Form 36 (SF-36) mental and physical component summary scores were collected. Time to first headache and associations with SF-36 scores were analyzed using Cox proportional hazards and linear regression models with generalized estimating equations. RESULTS: Among the 1,732 SLE patients enrolled, 89.3% were female and 48.3% were white. The mean ± SD age was 34.6 ± 13.4 years, duration of disease was 5.6 ± 5.2 months, and length of followup was 3.8 ± 3.1 years. At enrollment, 17.8% of patients had headache (migraine [60.7%], tension [38.6%], intractable nonspecific [7.1%], cluster [2.6%], and intracranial hypertension [1.0%]). The prevalence of headache increased to 58% after 10 years. Only 1.5% of patients had lupus headache, as identified in the SLEDAI-2K. In addition, headache was associated with other NP events attributed to either SLE or non-SLE causes. There was no association of headache with SLEDAI-2K scores (without the lupus headache variable), SDI scores, use of corticosteroids, use of antimalarials, use of immunosuppressive medications, or specific autoantibodies. SF-36 mental component scores were lower in patients with headache compared with those without headache (mean ± SD 42.5 ± 12.2 versus 47.8 ± 11.3; P < 0.001), and similar differences in physical component scores were seen (38.0 ± 11.0 in those with headache versus 42.6 ± 11.4 in those without headache; P < 0.001). In 56.1% of patients, the headaches resolved over followup. CONCLUSION: Headache is frequent in SLE, but overall, it is not associated with global disease activity or specific autoantibodies. Although headaches are associated with a lower HRQOL, the majority of headaches resolve over time, independent of lupus-specific therapies.
Asunto(s)
Autoanticuerpos/sangre , Cefalea/epidemiología , Cefalea/inmunología , Lupus Eritematoso Sistémico/epidemiología , Lupus Eritematoso Sistémico/inmunología , Adulto , Cefalalgia Histamínica/epidemiología , Cefalalgia Histamínica/inmunología , Femenino , Estudios de Seguimiento , Humanos , Internacionalidad , Hipertensión Intracraneal/epidemiología , Hipertensión Intracraneal/inmunología , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Trastornos Migrañosos/epidemiología , Trastornos Migrañosos/inmunología , Modelos de Riesgos Proporcionales , Estudios Prospectivos , Calidad de Vida , Cefalea de Tipo Tensional/epidemiología , Cefalea de Tipo Tensional/inmunología , Adulto JovenRESUMEN
BACKGROUND: Respiratory viral illness (RVI)-e.g., influenza, COVID-19-is a serious threat in long-term care (LTC) facilities. Standard infection control measures are suboptimal in LTC facilities because of residents' cognitive impairments, care needs, and susceptibility to loneliness and mental illness. Further, LTC residents living with high degrees of frailty who contract RVIs often develop the so-called atypical symptoms (e.g., delirium, worse mobility) instead of typical cough and fever, delaying infection diagnosis and treatment. Although far-UVC (222 nm) light devices have shown potent antiviral activity in vitro, clinical efficacy remains unproven. METHODS: Following a study to assay acceptability at each site, this multicenter, double-blinded, cluster-randomized, placebo-controlled trial aims to assess whether far-UVC light devices impact the incidence of RVIs in LTC facilities. Neighborhoods within LTC facilities are randomized to receive far-UVC light devices (222 nm) or identical placebo light devices that emit only visible spectrum light (400-700 nm) in common areas. All residents are monitored for RVIs using both a standard screening protocol and a novel screening protocol that target atypical symptoms. The 3-year incidence of RVIs will be compared using intention-to-treat analysis. A cost-consequence analysis will follow. DISCUSSION: This trial aims to inform decisions about whether to implement far-UVC light in LTC facilities for RVI prevention. The trial design features align with this pragmatic intent. Appropriate additional ethical protections have been implemented to mitigate participant vulnerabilities that arise from conducting this study. Knowledge dissemination will be supported through media engagement, peer-reviewed presentations, and publications. TRIAL REGISTRATION: ClinicalTrials.gov NCT05084898. October 20, 2021.
Asunto(s)
COVID-19 , SARS-CoV-2 , Humanos , Cuidados a Largo Plazo , Instituciones de Salud , Instituciones de Cuidados Especializados de Enfermería , Resultado del Tratamiento , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Multicéntricos como AsuntoRESUMEN
INTRODUCTION: The Enhanced Recovery After Cardiac Surgery protocol is the most recent addition to cardiac treatment. In this paper, we aimed to test the safety and viability of this protocol in our hospital to improve our standard of care. METHODS: This study was conducted as an experimental study with a historical control at the Maritime Heart Center, Halifax, Nova Scotia, Canada. In order to quantify the success of this protocol, we measured the postoperative Length of Hospital Stay and three intensive care unit variables: time to extubation, time to ambulation, and opioid consumption. In the study, 100 patients were in the Enhanced Recovery After Cardiac Surgery group, and 103 patients were used as historic controls-selected by strenuous chart review and selection criteria. RESULTS: The primary outcome (Length of Hospital Stay) was reduced from a mean of 8.88 ± 3.50 days in the control group to a mean of 5.13 ± 1.34 days in the Enhanced Recovery After Cardiac Surgery group (p < 0.001). Likewise, we observed a significant reduction in intensive care unit variables: time to extubation was reduced from 10.54 ± 7.83â h in the control group to 6.69 ± 1.63 in the Enhanced Recovery After Cardiac Surgery group (p < 0.01), and time to ambulation was reduced from 36.27 ± 35.21â h in the control group to 9.78 ± 2.03 in the Enhanced Recovery After Cardiac Surgery group (p < 0.01) and opioid consumption was reduced from 50.58 ± 11.93 milligram morphine equivalent in the control group to 11.58 ± 4.43 milligram morphine equivalent in the Enhanced Recovery After Cardiac Surgery group (p < 0.01). CONCLUSION: Enhanced Recovery After Cardiac Surgery protocols were seamlessly integrated into selected cardiac surgical patients, contingent on a high level of interprofessional communication and collaboration.
Asunto(s)
Analgésicos Opioides , Procedimientos Quirúrgicos Cardíacos , Humanos , Analgésicos Opioides/uso terapéutico , Grupos Control , Procedimientos Quirúrgicos Cardíacos/efectos adversos , Unidades de Cuidados Intensivos , Derivados de la Morfina , Tiempo de Internación , Dolor Postoperatorio/diagnóstico , Dolor Postoperatorio/etiología , Dolor Postoperatorio/prevención & controlRESUMEN
OBJECTIVE: The aim of this study was to describe the frequency, attribution, outcome and predictors of seizures in systemic lupus erythematosus (SLE). METHODS: The Systemic Lupus International Collaborating Clinics, or SLICC, performed a prospective inception cohort study. Demographic variables, global SLE disease activity (SLE Disease Activity Index 2000), cumulative organ damage (SLICC/American College of Rheumatology Damage Index (SDI)) and neuropsychiatric events were recorded at enrolment and annually. Lupus anticoagulant, anticardiolipin, anti-ß(2) glycoprotein-I, antiribosomal P and anti-NR2 glutamate receptor antibodies were measured at enrolment. Physician outcomes of seizures were recorded. Patient outcomes were derived from the SF-36 (36-Item Short Form Health Survey) mental component summary and physical component summary scores. Statistical analyses included Cox and linear regressions. RESULTS: The cohort was 89.4% female with a mean follow-up of 3.5±2.9 years. Of 1631 patients, 75 (4.6%) had ≥1 seizure, the majority around the time of SLE diagnosis. Multivariate analysis indicated a higher risk of seizures with African race/ethnicity (HR (CI): 1.97 (1.07 to 3.63); p=0.03) and lower education status (1.97 (1.21 to 3.19); p<0.01). Higher damage scores (without neuropsychiatric variables) were associated with an increased risk of subsequent seizures (SDI=1:3.93 (1.46 to 10.55); SDI=2 or 3:1.57 (0.32 to 7.65); SDI≥4:7.86 (0.89 to 69.06); p=0.03). There was an association with disease activity but not with autoantibodies. Seizures attributed to SLE frequently resolved (59/78 (76%)) in the absence of antiseizure drugs. There was no significant impact on the mental component summary or physical component summary scores. Antimalarial drugs in the absence of immunosuppressive agents were associated with reduced seizure risk (0.07 (0.01 to 0.66); p=0.03). CONCLUSION: Seizures occurred close to SLE diagnosis, in patients with African race/ethnicity, lower educational status and cumulative organ damage. Most seizures resolved without a negative impact on health-related quality of life. Antimalarial drugs were associated with a protective effect.
Asunto(s)
Epilepsia/complicaciones , Epilepsia/epidemiología , Lupus Eritematoso Sistémico/complicaciones , Estudios de Cohortes , Femenino , Humanos , Masculino , Persona de Mediana Edad , Modelos de Riesgos Proporcionales , Factores de RiesgoRESUMEN
BACKGROUND: Non-disabling stroke (NDS) and transient ischemic attack (TIA) herald the possibility of future, more debilitating vascular events. Evidence is conflicting about potency of exercise and education in reducing risk factors for second stroke. METHODS: Three-site, single-blinded, randomized controlled trial with 184 participants <3 months of NDS or TIA (mean age, 65 years; 66% male) randomized to usual care (UC) or UC + 12-week program of exercise and education (PREVENT). Primary (resting systolic blood pressure) and secondary outcomes (diastolic blood pressure [DBPrest], high-density lipoprotein cholesterol [HDL-C], low-density lipoprotein cholesterol [LDL-C], total cholesterol [TC], TC/HDL, triglycerides, fasting glucose, and body mass index) were assessed at baseline, post-intervention, and 6- and 12-month follow-up. Peak oxygen consumption (VO2peak) was measured at baseline, post-intervention, 12-month assessments. RESULTS: Significant between-group differences at post-intervention favored PREVENT group over UC: DBPrest (mean difference [MD]: -3.2 mmHg, 95% confidence interval [CI]: -6.3, -.2, P = .04) and LDL-C (MD: -.31 mmol/L, 95% CI: -.42, -.20, P = .02). Trends of improvement in PREVENT group were noted in several variables between baseline and 6-month follow-up but not sustained at 12-month follow-up. Of note, VO2 peak did not change over time in either group. CONCLUSION: Impact of PREVENT on vascular risk factor reduction was more modest than anticipated, possibly because several outcome variables approximated normative values at baseline and training intensity may have been sub-optimal. Further investigation is warranted to determine when exercise and education programs are viable adjuncts to pharmaceutical management for reduction of risk factors for second stroke.Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: #NCT00885456.
Asunto(s)
Terapia por Ejercicio , Factores de Riesgo de Enfermedad Cardiaca , Ataque Isquémico Transitorio/rehabilitación , Educación del Paciente como Asunto , Rehabilitación de Accidente Cerebrovascular , Accidente Cerebrovascular/terapia , Anciano , Terapia por Ejercicio/métodos , Femenino , Estudios de Seguimiento , Humanos , Ataque Isquémico Transitorio/sangre , Masculino , Persona de Mediana Edad , Evaluación de Resultado en la Atención de Salud , Gravedad del Paciente , Educación del Paciente como Asunto/métodos , Método Simple Ciego , Accidente Cerebrovascular/sangre , Rehabilitación de Accidente Cerebrovascular/métodosRESUMEN
OBJECTIVE: To determine the frequency, clinical characteristics, associations, and outcomes of different types of peripheral nervous system (PNS) disease in a multiethnic/multiracial, prospective inception cohort of systemic lupus erythematosus (SLE) patients. METHODS: Patients were evaluated annually for 19 neuropsychiatric (NP) events including 7 types of PNS disease. SLE disease activity, organ damage, autoantibodies, and patient and physician assessment of outcome were measured. Time to event and linear regressions were used as appropriate. RESULTS: Of 1,827 SLE patients, 88.8% were female, and 48.8% were white. The mean ± SD age was 35.1 ± 13.3 years, disease duration at enrollment was 5.6 ± 4.2 months, and follow-up was 7.6 ± 4.6 years. There were 161 PNS events in 139 (7.6%) of 1,827 patients. The predominant events were peripheral neuropathy (66 of 161 [41.0%]), mononeuropathy (44 of 161 [27.3%]), and cranial neuropathy (39 of 161 [24.2%]), and the majority were attributed to SLE. Multivariate Cox regressions suggested longer time to resolution in patients with a history of neuropathy, older age at SLE diagnosis, higher SLE Disease Activity Index 2000 scores, and for peripheral neuropathy versus other neuropathies. Neuropathy was associated with significantly lower Short Form 36 (SF-36) physical and mental component summary scores versus no NP events. According to physician assessment, the majority of neuropathies resolved or improved over time, which was associated with improvements in SF-36 summary scores for peripheral neuropathy and mononeuropathy. CONCLUSION: PNS disease is an important component of total NPSLE and has a significant negative impact on health-related quality of life. The outcome is favorable for most patients, but our findings indicate that several factors are associated with longer time to resolution.
Asunto(s)
Enfermedades de los Nervios Craneales/fisiopatología , Lupus Eritematoso Sistémico/fisiopatología , Vasculitis por Lupus del Sistema Nervioso Central/fisiopatología , Enfermedades del Sistema Nervioso Periférico/fisiopatología , Adulto , Factores de Edad , Estudios de Cohortes , Enfermedades de los Nervios Craneales/etiología , Femenino , Humanos , Lupus Eritematoso Sistémico/complicaciones , Masculino , Persona de Mediana Edad , Mononeuropatías/etiología , Mononeuropatías/fisiopatología , Análisis Multivariante , Enfermedades del Sistema Nervioso Periférico/etiología , Modelos de Riesgos Proporcionales , Índice de Severidad de la Enfermedad , Adulto JovenRESUMEN
Purpose: The tilt-rest skill consists of tipping the wheelchair back and allowing it to rest against a solid object with the wheel locks applied (e.g., for pressure redistribution, neck comfort or hands-free activities). The objective of this study was to determine the proportion of experienced manual wheelchair users who are aware of this skill and who can perform it. Materials and methods: We conducted a cross-sectional survey of 49 manual wheelchair users using a questionnaire developed for the purpose. The tilt-rest skill was attempted by those who reported that they were capable of performing it. Results: Participants' mean (SD) age was 55.1 (18.2) years, 38 (77.6%) were male, their median (IQR) duration of wheelchair use was 2 (7.2) years and their mean (SD) daily time spent in the wheelchair was 9.5 (4.6) hours. Twenty-seven (55.1%) participants were aware of the skill, 19 (38.8%) reported being able to perform the skill and 16 of 47 (34.0%) were able to demonstrate the skill. Multivariate modelling with the question "Can you complete the tilt-rest skill?" as the dependent measure revealed an inverse relationship with age - Odds Ratio (95% Confidence Interval) of 0.476 (0.293, 0.774) (p = .0028) for each 10 year increase in age. Conclusions: Only just over half of manual wheelchair users are aware of the tilt-rest skill and one-third of users can perform it. Older people are less likely to report being able to complete the skill. These findings have implications for wheelchair skills training during the wheelchair-provision process. Implications for Rehabilitation Only just over half of manual wheelchair users are aware of the tilt-rest skill and only about one-third of users can perform it. Older people are less likely to report being able to complete the skill. These findings have clinical implications for wheelchair skills training during the, specifically that clinicians responsible for manual wheelchair-provision process should ensure that appropriate wheelchair users have the opportunity to learn this skill.
Asunto(s)
Personas con Discapacidad , Conocimientos, Actitudes y Práctica en Salud , Destreza Motora , Silla de Ruedas , Adulto , Anciano , Estudios Transversales , Femenino , Humanos , Masculino , Persona de Mediana Edad , Encuestas y CuestionariosRESUMEN
OBJECTIVE: To determine, in a large, multiethnic/multiracial, prospective inception cohort of patients with systemic lupus erythematosus (SLE), the frequency, attribution, clinical, and autoantibody associations with lupus psychosis and the short- and long-term outcomes as assessed by physicians and patients. METHODS: Patients were evaluated annually for 19 neuropsychiatric (NP) events including psychosis. Scores on the Systemic Lupus Erythematosus Disease Activity Index 2000, the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index, and the Short Form 36 (SF-36) were recorded. Time to event and linear regressions were used as appropriate. RESULTS: Of 1,826 SLE patients, 88.8% were female and 48.8% were Caucasian. The mean ± SD age was 35.1 ± 13.3 years, the mean ± SD disease duration was 5.6 ± 4.2 months, and the mean ± SD follow-up period was 7.4 ± 4.5 years. There were 31 psychotic events in 28 of 1,826 patients (1.53%), and most patients had a single event (26 of 28 [93%]). In the majority of patients (20 of 25 [80%]) and events (28 of 31 [90%]), psychosis was attributed to SLE, usually either in the year prior to or within 3 years of SLE diagnosis. Positive associations (hazard ratios [HRs] and 95% confidence intervals [95% CIs]) with lupus psychosis were previous SLE NP events (HR 3.59 [95% CI 1.16-11.14]), male sex (HR 3.0 [95% CI 1.20-7.50]), younger age at SLE diagnosis (per 10 years) (HR 1.45 [95% CI 1.01-2.07]), and African ancestry (HR 4.59 [95% CI 1.79-11.76]). By physician assessment, most psychotic events resolved by the second annual visit following onset, in parallel with an improvement in patient-reported SF-36 summary and subscale scores. CONCLUSION: Psychosis is an infrequent manifestation of NPSLE. Generally, it occurs early after SLE onset and has a significant negative impact on health status. As determined by patient and physician report, the short- and long-term outlooks are good for most patients, although careful follow-up is required.
Asunto(s)
Vasculitis por Lupus del Sistema Nervioso Central/epidemiología , Trastornos Psicóticos/epidemiología , Adulto , Factores de Edad , Anticuerpos Anticardiolipina/inmunología , Autoanticuerpos/inmunología , Estudios de Cohortes , Femenino , Humanos , Estimación de Kaplan-Meier , Modelos Lineales , Inhibidor de Coagulación del Lupus/inmunología , Lupus Eritematoso Sistémico/epidemiología , Lupus Eritematoso Sistémico/inmunología , Vasculitis por Lupus del Sistema Nervioso Central/inmunología , Masculino , Persona de Mediana Edad , Modelos de Riesgos Proporcionales , Estudios Prospectivos , Trastornos Psicóticos/inmunología , Receptores de N-Metil-D-Aspartato/inmunología , Factores Sexuales , Adulto Joven , beta 2 Glicoproteína I/inmunologíaRESUMEN
PURPOSE: Sellar masses may present either with clinical manifestations of mass effect/hormonal dysfunction (CMSM) or incidentally on imaging (pituitary incidentaloma (PI)). This novel population-based study compares these two entities. METHODS: Retrospective analysis of all patients within a provincial pituitary registry between January 2006 and June 2014. RESULTS: Nine hundred and three patients were included (681 CMSM, 222 PI). CMSM mainly presented with secondary hormone deficiencies (SHDs) or stalk compression (29.7%), whereas PIs were found in association with neurological complaints (34.2%) (P < 0.0001). PIs were more likely to be macroadenomas (70.7 vs 49.9%; P < 0.0001). The commonest pathologies among CMSM were prolactinomas (39.8%) and non-functioning adenomas (NFAs) (50%) in PI (P < 0.0001). SHDs were present in 41.3% CMSM and 31.1% PI patients (P < 0.0001) and visual field deficit in 24.2 and 29.3%, respectively (P = 0.16). CMSM were more likely to require surgery (62.9%) than PI (35.8%) (P < 0.0005). The commonest surgical indications were impaired vision and radiological evidence of optic nerve compression. Over a follow-up period of 5.7 years for CMSM and 5.0 years for PI, tumour growth/recurrence occurred in 7.8% of surgically treated CMSM and 2.6% without surgery and PI, 0 and 4.9%, respectively (P = 1.0). There were no significant differences in the risk of new-onset SHD in CMSM vs PI in those who underwent surgery (P = 0.7) and those who were followed without surgery (P = 0.58). CONCLUSIONS: This novel study compares the long-term trends of PI with CMSM, highlighting the need for comprehensive baseline and long-term radiological and hormonal evaluations in both entities.