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BACKGROUND: The association between chest compression (CC) pause duration and pediatric in-hospital cardiac arrest survival outcomes is unknown. The American Heart Association has recommended minimizing pauses in CC in children to <10 seconds, without supportive evidence. We hypothesized that longer maximum CC pause durations are associated with worse survival and neurological outcomes. METHODS: In this cohort study of index pediatric in-hospital cardiac arrests reported in pediRES-Q (Quality of Pediatric Resuscitation in a Multicenter Collaborative) from July of 2015 through December of 2021, we analyzed the association in 5-second increments of the longest CC pause duration for each event with survival and favorable neurological outcome (Pediatric Cerebral Performance Category ≤3 or no change from baseline). Secondary exposures included having any pause >10 seconds or >20 seconds and number of pauses >10 seconds and >20 seconds per 2 minutes. RESULTS: We identified 562 index in-hospital cardiac arrests (median [Q1, Q3] age 2.9 years [0.6, 10.0], 43% female, 13% shockable rhythm). Median length of the longest CC pause for each event was 29.8 seconds (11.5, 63.1). After adjustment for confounders, each 5-second increment in the longest CC pause duration was associated with a 3% lower relative risk of survival with favorable neurological outcome (adjusted risk ratio, 0.97 [95% CI, 0.95-0.99]; P=0.02). Longest CC pause duration was also associated with survival to hospital discharge (adjusted risk ratio, 0.98 [95% CI, 0.96-0.99]; P=0.01) and return of spontaneous circulation (adjusted risk ratio, 0.93 [95% CI, 0.91-0.94]; P<0.001). Secondary outcomes of any pause >10 seconds or >20 seconds and number of CC pauses >10 seconds and >20 seconds were each significantly associated with adjusted risk ratio of return of spontaneous circulation, but not survival or neurological outcomes. CONCLUSIONS: Each 5-second increment in longest CC pause duration during pediatric in-hospital cardiac arrest was associated with lower chance of survival with favorable neurological outcome, survival to hospital discharge, and return of spontaneous circulation. Any CC pause >10 seconds or >20 seconds and number of pauses >10 seconds and >20 seconds were significantly associated with lower adjusted probability of return of spontaneous circulation, but not survival or neurological outcomes.
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Reanimação Cardiopulmonar , Parada Cardíaca , Humanos , Parada Cardíaca/mortalidade , Parada Cardíaca/terapia , Feminino , Masculino , Criança , Pré-Escolar , Reanimação Cardiopulmonar/mortalidade , Fatores de Tempo , Lactente , Resultado do Tratamento , AdolescenteRESUMO
BACKGROUND: In the BEST-CLI trial (Best Endovascular Versus Best Surgical Therapy for Patients With Chronic Limb-Threatening Ischemia), a prespecified secondary objective was to assess the effects of revascularization strategy on health-related quality of life (HRQoL). METHODS: Patients with chronic limb-threatening ischemia were randomized to surgical bypass (Bypass) or endovascular intervention (Endo) in 2 parallel trials. Cohort 1 included patients with single-segment great saphenous vein; cohort 2 included those lacking suitable single-segment great saphenous vein. HRQoL was assessed over the trial duration using Vascular Quality-of-Life (VascuQoL), European Quality-of-Life-5D (EQ-5D), the Short Form-12 (SF-12) Physical Component Summary (SF-12 PCS), SF-12 Mental Component Summary (SF-12 MCS), Utility Index Score (SF-6D R2), and numeric rating scales of pain. HRQoL was summarized by cohort and compared within and between groups using mixed-model linear regression. RESULTS: A total of 1193 and 335 patients in cohorts 1 and 2 with a mean follow-up of 2.9 and 2.0 years, respectively, were analyzed. In cohort 1, HRQoL significantly improved from baseline to follow-up for both groups across all measures. For example, mean (SD) VascuQoL scores were 3.0 (1.3) and 3.0 (1.2) for Bypass and Endo at baseline and 4.7 (1.4) and 4.8 (1.5) over follow-up. There were significant group differences favoring Endo when assessed with VascuQoL (difference, -0.14 [95% CI, -0.25 to -0.02]; P=0.02), SF-12 MCS (difference, -1.03 [95% CI, -1.89 to -0.18]; P=0.02), SF-6D R2 (difference, -0.01 [95% CI, -0.02 to -0.001]; P=0.03), numeric rating scale pain at present (difference, 0.26 [95% CI, 0.03 to 0.49]; P=0.03), usual level during previous week (difference, 0.26 [95% CI, 0.04 to 0.48]; P=0.02), and worst level during previous week (difference, 0.29 [95% CI, 0.02 to 0.56]; P=0.04). There was no difference between treatment arms on the basis of EQ-5D (difference, -0.01 [95% CI, -0.03 to 0.004]; P=0.12) or SF-12 PCS (difference, -0.41 [95% CI, -1.2 to 0.37]; P=0.31). In cohort 2, HRQoL also significantly improved from baseline to the end of follow-up for both groups based on all measures, but there were no differences between Bypass and Endo on any measure. CONCLUSIONS: Among patients with chronic limb-threatening ischemia deemed eligible for either Bypass or Endo, revascularization resulted in significant and clinically meaningful improvements in HRQoL. In patients with an available single-segment great saphenous vein for bypass, but not among those without one, Endo was statistically superior on some HRQoL measures; however, these differences were below the threshold of clinically meaningful difference.
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Isquemia Crônica Crítica de Membro , Qualidade de Vida , Humanos , Procedimentos Cirúrgicos Vasculares , Dor , Resultado do TratamentoRESUMO
SignificanceRecord-setting fires in the western United States over the last decade caused severe air pollution, loss of human life, and property damage. Enhanced drought and increased biomass in a warmer climate may fuel larger and more frequent wildfires in the coming decades. Applying an empirical statistical model to fires projected by Earth System Models including climate-ecosystem-socioeconomic interactions, we show that fine particulate pollution over the US Pacific Northwest could double to triple during late summer to fall by the late 21st century under intermediate- and low-mitigation scenarios. The historic fires and resulting pollution extremes of 2017-2020 could occur every 3 to 5 y under 21st-century climate change, posing challenges for air quality management and threatening public health.
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Poluição do Ar , Incêndios , Incêndios Florestais , Poluição do Ar/análise , Mudança Climática , Ecossistema , Humanos , Minerais , Saúde Pública , Estados UnidosRESUMO
Air pollution levels in the United States have decreased dramatically over the past decades, yet national racial-ethnic exposure disparities persist. For ambient fine particulate matter ([Formula: see text]), we investigate three emission-reduction approaches and compare their optimal ability to address two goals: 1) reduce the overall population average exposure ("overall average") and 2) reduce the difference in the average exposure for the most exposed racial-ethnic group versus for the overall population ("national inequalities"). We show that national inequalities in exposure can be eliminated with minor emission reductions (optimal: ~1% of total emissions) if they target specific locations. In contrast, achieving that outcome using existing regulatory strategies would require eliminating essentially all emissions (if targeting specific economic sectors) or is not possible (if requiring urban regions to meet concentration standards). Lastly, we do not find a trade-off between the two goals (i.e., reducing overall average and reducing national inequalities); rather, the approach that does the best for reducing national inequalities (i.e., location-specific strategies) also does as well as or better than the other two approaches (i.e., sector-specific and meeting concentration standards) for reducing overall averages. Overall, our findings suggest that incorporating location-specific emissions reductions into the US air quality regulatory framework 1) is crucial for eliminating long-standing national average exposure disparities by race-ethnicity and 2) can benefit overall average exposures as much as or more than the sector-specific and concentration-standards approaches.
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Poluentes Atmosféricos , Poluição do Ar , Estados Unidos , Humanos , Poluentes Atmosféricos/análise , Etnicidade , Exposição Ambiental/prevenção & controle , Exposição Ambiental/análise , Poluição do Ar/prevenção & controle , Poluição do Ar/análise , Material Particulado/análiseRESUMO
BACKGROUND AND AIMS: There is significant potential to streamline the clinical pathway for patients undergoing transcatheter aortic valve implantation (TAVI). The purpose of this study was to evaluate the effect of implementing BENCHMARK best practices on the efficiency and safety of TAVI in 28 sites in 7 European countries. METHODS: This was a study of patients with severe symptomatic aortic stenosis (AS) undergoing TAVI with balloon-expandable valves before and after implementation of BENCHMARK best practices. Principal objectives were to reduce hospital length of stay (LoS) and duration of intensive care stay. Secondary objective was to document patient safety. RESULTS: Between January 2020 and March 2023, 897 patients were documented prior to and 1491 patients after the implementation of BENCHMARK practices. Patient characteristics were consistent with a known older TAVI population and only minor differences. Mean LoS was reduced from 7.7 ± 7.0 to 5.8 ± 5.6 days (median 6 vs. 4 days; P < .001). Duration of intensive care was reduced from 1.8 to 1.3 days (median 1.1 vs. 0.9 days; P < .001). Adoption of peri-procedure best practices led to increased use of local anaesthesia (96.1% vs. 84.3%; P < .001) and decreased procedure (median 47 vs. 60â min; P < .001) and intervention times (85 vs. 95â min; P < .001). Thirty-day patient safety did not appear to be compromised with no differences in all-cause mortality (0.6% in both groups combined), stroke/transient ischaemic attack (1.4%), life-threatening bleeding (1.3%), stage 2/3 acute kidney injury (0.7%), and valve-related readmission (1.2%). CONCLUSIONS: Broad implementation of BENCHMARK practices contributes to improving efficiency of TAVI pathway reducing LoS and costs without compromising patient safety.
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Estenose da Valva Aórtica , Benchmarking , Tempo de Internação , Substituição da Valva Aórtica Transcateter , Humanos , Substituição da Valva Aórtica Transcateter/métodos , Estenose da Valva Aórtica/cirurgia , Masculino , Feminino , Idoso de 80 Anos ou mais , Tempo de Internação/estatística & dados numéricos , Idoso , Procedimentos Clínicos , Europa (Continente)/epidemiologia , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/prevenção & controle , Segurança do PacienteRESUMO
BACKGROUND: Asians in the United States, facing health care disparities, have increased stroke risk. Multiple subgroups, with distinct cultures and languages, add complexity to caring for Asian American (AsA) communities. We developed a tailored stroke education program for underserved West Michigan AsA communities. Methodology, lessons learned, and diversity, equity, and inclusion insights are described. METHODS: Neurology residents and faculty, in collaboration with trained community-specific navigators, developed culturally resonant stroke education that was tailored to meet the needs of specific self-identified West Michigan AsA communities. Educational and debriefing sessions were delivered over 6 months, following the Plan-Do-Study-Act model, to elucidate diversity, equity, and inclusion insights and improve materials and delivery methods. RESULTS: Eighty-six non-English-speaking participants from 5 self-identified AsA communities (Burmese, Buddhist Vietnamese, Catholic Vietnamese, Chinese, and Nepali) attended educational stroke sessions. The average age of attendees was 57.6±13.2 years; most were females (70%). Diversity, equity, and inclusion insights included identification of Asian cultural beliefs about acute stroke treatment (eg, bloodletting), investigator insights (eg, need for kitchen-table programs), systemic barriers (eg, language), and mitigation strategies. CONCLUSIONS: Institutions should consider the integration of equity-focused, trainee-influenced quality improvement projects, such as this culturally resonant stroke educational program for AsA, to enhance stroke care in these vulnerable communities.
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Povo Asiático , Diversidade, Equidade, Inclusão , Promoção da Saúde , Acidente Vascular Cerebral , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Asiático , Escolaridade , Michigan/epidemiologia , Estados Unidos , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etnologia , Acidente Vascular Cerebral/terapiaRESUMO
BACKGROUND: Recent evidence from thrombolysis trials indicates the noninferiority of intravenous tenecteplase to intravenous alteplase with respect to good functional outcomes in patients with acute stroke. We examined whether the health-related quality of life (HRQOL) of patients with acute stroke differs by the type of thrombolysis treatment received. In addition, we examined the association between the modified Rankin Scale score 0 to 1 and HRQOL and patient-reported return to prebaseline stroke functioning at 90 days. METHODS: Data were from all patients included in the AcT trial (Alteplase Compared to Tenecteplase), a pragmatic, registry-linked randomized trial comparing tenecteplase with alteplase. HRQOL at 90-day post-randomization was assessed using the 5-item EuroQOL questionnaire (EQ5D), which consists of 5 items and a visual analog scale (VAS). EQ5D index values were estimated from the EQ5D items using the time tradeoff approach based on Canadian norms. Tobit regression and quantile regression models were used to evaluate the adjusted effect of tenecteplase versus alteplase treatment on the EQ5D index values and VAS score, respectively. The association between return to prebaseline stroke functioning and the modified Rankin Scale score 0 to 1 and HRQOL was quantified using correlation coefficient (r) with 95% CI. RESULTS: Of 1577 included in the intention-to-treat analysis patients, 1503 (95.3%) had complete data on the EQ5D. Of this, 769 (51.2%) were administered tenecteplase and 717 (47.7%) were female. The mean EQ5D VAS score and EQ5D index values were not significantly higher for those who received intravenous tenecteplase compared with those who received intravenous alteplase (P=0.10). Older age (P<0.01), more severe stroke assessed using the National Institutes of Health Stroke Scale (P<0.01), and longer stroke onset-to-needle time (P=0.004) were associated with lower EQ5D index and VAS scores. There was a strong association (r, 0.85 [95% CI, 0.81-0.89]) between patient-reported return to prebaseline functioning and modified Rankin Scale score 0 to 1 Similarly, there was a moderate association between return to prebaseline functioning and EQ5D index (r, 0.45 [95% CI, 0.40-0.49]) and EQ5D VAS scores (r, 0.42 [95% CI, 0.37-0.46]). CONCLUSIONS: Although there is no differential effect of thrombolysis type on patient-reported global HRQOL and EQ 5D-5L index values in patients with acute stroke, sex- and age-related differences in HRQOL were noted in this study. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03889249.
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Isquemia Encefálica , AVC Isquêmico , Acidente Vascular Cerebral , Humanos , Feminino , Masculino , Ativador de Plasminogênio Tecidual , Tenecteplase/efeitos adversos , Fibrinolíticos , AVC Isquêmico/tratamento farmacológico , Qualidade de Vida , Isquemia Encefálica/tratamento farmacológico , Isquemia Encefálica/induzido quimicamente , Canadá , Acidente Vascular Cerebral/tratamento farmacológico , Acidente Vascular Cerebral/induzido quimicamente , Terapia Trombolítica , Resultado do TratamentoRESUMO
Late presentation for kidney replacement therapy (KRT) is an important cause of avoidable morbidity and mortality. Here, we evaluated the effect of a complex intervention of graphical estimated glomerular filtration rate (eGFR) surveillance across 15% of the United Kingdom population on the rate of late presentation using data routinely collected by the United Kingdom Renal Registry. A stepped wedge cluster randomized trial was established across 19 sites with eGFR graphs generated from all routine blood tests (community and hospital) across the population served by each site. Graphs were reviewed by trained laboratory or clinical staff and high-risk graphs reported to family doctors. Due to delays outside the control of clinicians and researchers few laboratories activated the intervention in their randomly assigned time period, so the trial was converted to a quasi-experimental design. We studied 6,100 kidney failure events at 20 laboratories served by 17 main kidney units. A total of 63,981 graphs were sent out. After adjustment for calendar time there was no significant reduction in the rate of presentation during the intervention period. Therefore, implementation of eGFR graph surveillance did not reduce the rate of late presentation for KRT after adjustment for secular trends. Thus, graphical surveillance is an intervention aimed at reducing late presentation, but more evidence is required before adoption of this strategy can be recommended.
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Taxa de Filtração Glomerular , Terapia de Substituição Renal , Humanos , Terapia de Substituição Renal/estatística & dados numéricos , Terapia de Substituição Renal/métodos , Reino Unido/epidemiologia , Masculino , Feminino , Idoso , Pessoa de Meia-Idade , Sistema de Registros/estatística & dados numéricos , Fatores de Tempo , Rim/fisiopatologia , Tempo para o Tratamento/estatística & dados numéricosRESUMO
BACKGROUND: Urinary incontinence (UI) can negatively impact quality of life (QoL) after robot-assisted radical prostatectomy (RARP). Pelvic floor muscle training (PFMT) and duloxetine are used to manage post-RARP UI, but their efficacy remains uncertain. We aimed to investigate the efficacy of PFMT and duloxetine in promoting urinary continence recovery (UCR) after RARP. METHODS: A randomized controlled trial involving patients with urine leakage after RARP from May 2015 to February 2018. Patients were randomized into 1 of 4 arms: (1) PFMT-biofeedback, (2) duloxetine, (3) combined PFMT-biofeedback and duloxetine, (4) control arm. PFMT consisted of pelvic muscle exercises conducted with electromyographic feedback weekly, for 3 months. Oral duloxetine was administered at bedtime for 3 months. The primary outcome was prevalence of continence at 6 months, defined as using ≤1 security pad. Urinary symptoms and QoL were assessed by using a visual analogue scale, and validated questionnaires. RESULTS: From the 240 patients included in the trial, 89% of patients completed 1 year of follow-up. Treatment compliance was observed in 88% (92/105) of patients receiving duloxetine, and in 97% (104/107) of patients scheduled to PFMT-biofeedback sessions. In the control group 96% of patients had achieved continence at 6 months, compared with 90% (p = 0.3) in the PMFT-biofeedback, 73% (p = 0.008) in the duloxetine, and 69% (p = 0.003) in the combined treatment arm. At 6 months, QoL was classified as uncomfortable or worse in 17% of patients in the control group, compared with 44% (p = 0.01), 45% (p = 0.008), and 34% (p = 0.07), respectively. Complete preservation of neurovascular bundles (NVB) (OR: 2.95; p = 0.048) was the only perioperative intervention found to improve early UCR. CONCLUSIONS: PFMT-biofeedback and duloxetine demonstrated limited impact in improving UCR after RP. Diligent NVB preservation, along with preoperative patient and disease characteristics, are the primary determinants for early UCR.
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Qualidade de Vida , Incontinência Urinária , Masculino , Humanos , Cloridrato de Duloxetina/uso terapêutico , Diafragma da Pelve , Resultado do Tratamento , Incontinência Urinária/etiologia , Incontinência Urinária/terapia , Prostatectomia/efeitos adversosRESUMO
BACKGROUND: Long-term opioid use is associated with dependency, addiction, and serious adverse events. Although a framework to reduce inappropriate opioid prescribing exists, there is no consensus on prescribing indicators for preventable opioid-related problems in patients with chronic pain in primary care in the UK. This study aimed to identify opioid prescription scenarios for developing indicators for prescribing opioids to patients with chronic pain in primary care. METHODS: Scenarios of opioid prescribing indicators were identified from a literature review, guidelines, and government reports. Twenty-one indicators were identified and presented in various opioid scenarios concerning opioid-related harm and adverse effects, drug-drug interactions, and drug-disease interactions in certain disease conditions. After receiving ethics approval, two rounds of electronic Delphi panel technique surveys were conducted with 24 expert panellists from the UK (clinicians, pharmacists, and independent prescribers) from August 2020 to February 2021. Each indicator was rated on a 1-9 scale from inappropriate to appropriate. The score's median, 30th and 70th percentiles, and disagreement index were calculated. RESULTS: The panel unanimously agreed that 15 out of the 21 opioid prescribing scenarios were inappropriate, primarily due to their potential for causing harm to patients. This consensus was reflected in the low appropriateness scores (median ranging from 1 to 3). There were no scenarios with a high consensus that prescribing was appropriate. The indicators were considered inappropriate due to drug-disease interactions (n = 8), drug-drug interactions (n = 2), adverse effects (n = 3), and prescribed dose and duration (n = 2). Examples included prescribing opioids during pregnancy, concurrently with benzodiazepines, long-term without a laxative prescription and prescribing > 120-mg morphine milligram equivalent per day or long-term duration over 3 months after surgery. CONCLUSIONS: The high agreement on opioid prescribing indicators indicates that these potentially hazardous consequences are relevant and concerning to healthcare practitioners. Future research is needed to evaluate the feasibility and implementation of these indicators within primary care settings. This research will provide valuable insights and evidence to support opioid prescribing and deprescribing strategies. Moreover, the findings will be crucial in informing primary care practitioners and shaping quality outcome frameworks and other initiatives to enhance the safety and quality of care in primary care settings.
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Dor Crônica , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Humanos , Analgésicos Opioides/efeitos adversos , Dor Crônica/tratamento farmacológico , Técnica Delphi , Padrões de Prática Médica , Prescrições de Medicamentos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Atenção Primária à SaúdeRESUMO
BACKGROUND: Temporary doctors, known as locums, are a key component of the medical workforce in the NHS but evidence on differences in quality and safety between locum and permanent doctors is limited. We aimed to examine differences in the clinical practice, and prescribing safety for locum and permanent doctors working in primary care in England. METHODS: We accessed electronic health care records (EHRs) for 3.5 million patients from the CPRD GOLD database with linkage to Hospital Episode Statistics from 1st April 2010 to 31st March 2022. We used multi-level mixed effects logistic regression to compare consultations with locum and permanent GPs for several patient outcomes including general practice revisits; prescribing of antibiotics; strong opioids; hypnotics; A&E visits; emergency hospital admissions; admissions for ambulatory care sensitive conditions; test ordering; referrals; and prescribing safety indicators while controlling for patient and practice characteristics. RESULTS: Consultations with locum GPs were 22% more likely to involve a prescription for an antibiotic (OR = 1.22 (1.21 to 1.22)), 8% more likely to involve a prescription for a strong opioid (OR = 1.08 (1.06 to 1.09)), 4% more likely to be followed by an A&E visit on the same day (OR = 1.04 (1.01 to 1.08)) and 5% more likely to be followed by an A&E visit within 1 to 7 days (OR = 1.05 (1.02 to 1.08)). Consultations with a locum were 12% less likely to lead to a practice revisit within 7 days (OR = 0.88 (0.87 to 0.88)), 4% less likely to involve a prescription for a hypnotic (OR = 0.96 (0.94 to 0.98)), 15% less likely to involve a referral (OR = 0.85 (0.84 to 0.86)) and 19% less likely to involve a test (OR = 0.81 (0.80 to 0.82)). We found no evidence that emergency admissions, ACSC admissions and eight out of the eleven prescribing safety indicators were different if patients were seen by a locum or a permanent GP. CONCLUSIONS: Despite existing concerns, the clinical practice and performance of locum GPs did not appear to be systematically different from that of permanent GPs. The practice and performance of both locum and permanent GPs is likely shaped by the organisational setting and systems within which they work.
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Medicina de Família e Comunidade , Médicos de Família , Humanos , Inglaterra , Encaminhamento e Consulta , Antibacterianos/uso terapêutico , Atenção Primária à SaúdeRESUMO
Food insecurity affects an estimated 691-783 million people globally and is disproportionately high in Africa and Asia. It arises from poverty, armed conflict, and climate change, among other demographic and globalization forces. This review summarizes evidence for policies and practices across five elements of the agrifood system framework and identifies gaps that inform an agenda for future research. Under availability, imbalanced agriculture policies protect primarily staple food producers, and there is limited evidence on food security impacts for smallholder and women food producers. Evidence supports the use of cash transfers and food aid for affordability and school feeding for multiple benefits. Food-based dietary guidelines can improve the nutritional quality of dietary patterns, yet they may not reflect the latest evidence or food supplies. Evidence from the newer food environment elements, promotion and sustainability, while relatively minimal, provides insight into achieving long-term impacts. To eliminate hunger, our global community should embrace integrated approaches and bring evidence-based policies and practices to scale.
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Insegurança Alimentar , Humanos , Saúde Global , Abastecimento de Alimentos/normas , Política Nutricional , Agricultura , Assistência Alimentar/organização & administraçãoRESUMO
BACKGROUND: The Phase 3 COMET trial (NCT02782741) comparing avalglucosidase alfa and alglucosidase alfa included health-related quality of life (HRQoL) assessments in treatment-naïve patients with late-onset Pompe disease (LOPD). Here, we further characterize results from disease-specific and general patient-reported outcome (PRO) measures. METHODS: Adults who participated in the COMET trial receiving avalglucosidase alfa or alglucosidase alfa (both 20 mg/kg biweekly) during the 49-week double-blind treatment period were included in the analysis. Proportions of patients exceeding meaningful change thresholds at Week 49 were compared post hoc between treatment groups. PROs and their meaningful change thresholds included: Pompe Disease Severity Scale (PDSS; decrease 1.0-1.5 points), Pompe Disease Impact Scale (PDIS; decrease 1.0-1.5 points), Rasch-built Pompe-specific Activity Scale (R-PAct; change from unable to able to complete activity), 12-item Short Form Health Survey (SF-12; physical component summary [PCS] score: increase ≥6 points, mental component summary [MCS] score: increase ≥7 points), EuroQol 5 Dimension 5 Level (EQ-5D-5L; improvement of ≥1 category), and Patient Global Impression of Change (PGIC; any improvement). RESULTS: The analysis included 99 adult patients (avalglucosidase alfa n = 50; alglucosidase alfa n = 49). Patients who received avalglucosidase alfa had significantly greater odds of achieving a meaningful change versus alglucosidase alfa for the PDSS Shortness of Breath (OR [95% CI] 11.79 [2.24; 62.18]), Fatigue/Pain (6.24 [1.20; 32.54]), Morning Headache (13.98 [1.71; 114.18]), and Overall Fatigue (5.88 [1.37; 25.11]) domains, and were significantly more likely to meet meaningful change thresholds across multiple PDSS domains (all nominal p < 0.05). A numerically greater proportion of patients in the avalglucosidase alfa group were able to complete selected activities of the R-PAct compared with the alglucosidase alfa group. Significantly greater proportions of patients who received avalglucosidase alfa achieved meaningful improvements for EQ-5D-5L usual activities dimension, EQ visual analog scale, and all four PGIC domains. The proportion of patients with improvements in SF-12 PCS and MCS was greater in the avalglucosidase alfa group versus alglucosidase alfa group, but was not significant (p > 0.05). CONCLUSIONS: These analyses show that avalglucosidase alfa improves multiple symptoms and aspects of daily functioning, including breathing and mobility. This supports the clinical relevance of the effects of avalglucosidase alfa on HRQoL for patients with LOPD.
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Doença de Depósito de Glicogênio Tipo II , Adulto , Humanos , alfa-Glucosidases/uso terapêutico , Doença de Depósito de Glicogênio Tipo II/tratamento farmacológico , Qualidade de Vida , Resultado do TratamentoRESUMO
OBJECTIVES: Existing guidelines for psoriatic arthritis (PsA) cover many aspects of management. Some gaps remain relating to routine practice application. An expert group aimed to enhance current guidance and develop recommendations for clinical practice that are complementary to existing guidelines. METHODS: A steering committee comprising experienced, research-active clinicians in rheumatology, dermatology and primary care agreed on themes and relevant questions. A targeted literature review of PubMed and Embase following a PICO framework was conducted. At a second meeting, recommendations were drafted and subsequently an extended faculty comprising rheumatologists, dermatologists, primary care clinicians, specialist nurses, allied health professionals, non-clinical academic participants and members of the Brit-PACT patient group, was recruited. Consensus was achieved via an online voting platform when 75% of respondents agreed in the range of 7-9 on a 9-point scale. RESULTS: The guidance comprised 34 statements covering four PsA themes. Diagnosis focused on strategies to identify PsA early and refer appropriately, assessment of diagnostic indicators, use of screening tools and use of imaging. Disease assessment centred on holistic consideration of disease activity, physical functioning and impact from a patient perspective, and on how to implement shared decision-making. For comorbidities, recommendations included specific guidance for high-impact conditions such as depression and obesity. Management statements (which excluded extant guidance on pharmacological therapies) covered multidisciplinary team working, implementation of lifestyle modifications and treat-to-target strategies. Minimising corticosteroid use was recommended where feasible. CONCLUSION: The consensus group have made evidence-based best practice recommendations for the management of PsA to enhance the existing guidelines.
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Plants use light as a resource and signal. Photons within the 400-700 nm waveband are considered photosynthetically active. Far-red photons (FR, 700-800 nm) are used by plants to detect nearby vegetation and elicit the shade avoidance syndrome. In addition, FR photons have also been shown to contribute to photosynthesis, but knowledge about these dual effects remains scarce. Here, we study shoot-architectural and photosynthetic responses to supplemental FR light during the photoperiod in several rice varieties. We observed that FR enrichment only mildly affected the rice transcriptome and shoot architecture as compared to established model species, whereas leaf formation, tillering and biomass accumulation were clearly promoted. Consistent with this growth promotion, we found that CO2-fixation in supplemental FR was strongly enhanced, especially in plants acclimated to FR-enriched conditions as compared to control conditions. This growth promotion dominates the effects of FR photons on shoot development and architecture. When substituting FR enrichment with an end-of-day FR pulse, this prevented photosynthesis-promoting effects and elicited shade avoidance responses. We conclude that FR photons can have a dual role, where effects depend on the environmental context: in addition to being an environmental signal, they are also a potent source of harvestable energy.
Assuntos
Regulação da Expressão Gênica de Plantas , Luz , Oryza , Fotossíntese , Brotos de Planta , Oryza/genética , Oryza/crescimento & desenvolvimento , Oryza/efeitos da radiação , Oryza/fisiologia , Fotossíntese/efeitos da radiação , Regulação da Expressão Gênica de Plantas/efeitos da radiação , Brotos de Planta/crescimento & desenvolvimento , Brotos de Planta/efeitos da radiação , Brotos de Planta/genética , Folhas de Planta/efeitos da radiação , Folhas de Planta/crescimento & desenvolvimento , Folhas de Planta/genética , Folhas de Planta/fisiologia , Dióxido de Carbono/metabolismo , Fotoperíodo , Biomassa , Transcriptoma , Luz VermelhaRESUMO
STUDY QUESTION: Does the Mind/Body Program for Infertility (MBPI) perform better, due to certain distinctive elements, than a partly matched support group in improving the wellbeing and medically assisted reproduction (MAR) outcomes of women with elevated distress levels in a clinical setting? SUMMARY ANSWER: While robust enhancements occurred in the wellbeing overall, the cognitive behavioural and formalized stress management elements of the MBPI allowed a significantly stronger improvement in trait anxiety, but not in other mental health and MAR outcomes, compared with a support group. WHAT IS KNOWN ALREADY: Mind-body psychological programmes adjacent to MAR have been found to improve women's mental states and possibly increase chances of pregnancy. However, not enough is known about the programme's effectiveness among patients with elevated distress levels in routine clinical settings, nor is it clear which of its particular ingredients are specifically effective. STUDY DESIGN, SIZE, DURATION: A pre-post design, single-centre, randomized controlled trial was performed between December 2019 and October 2022 (start and end of recruitment, respectively). The sample size (n = 168) was calculated to detect superiority of the MBPI in improving fertility-related quality of life. Randomization was computer-based, with random numbers concealing identities of patients until after allocation. PARTICIPANTS/MATERIALS, SETTING, METHODS: The trial was conducted at a large university teaching hospital. A total of 168 patients were randomly assigned to the mind-body (MBPI) group (n = 84) and the fertility support (FS) control group (n = 84). Patients received a 10-week, 135-min/week group intervention, with the FS group following the same format as the MBPI group, but with a less restricted and systematic content, and without the presumed effective factors. The number of patients analysed was n = 74 (MBPI) and n = 68 (FS) for post-intervention psychological outcomes, and n = 54 (MBPI) and n = 56 (FS) for pregnancy outcomes at a 30-month follow-up. MAIN RESULTS AND THE ROLE OF CHANCE: Significant improvements occurred in both groups in all psychological domains (adjusted P < 0.001), except for treatment-related quality of life. Linear mixed-model regression analysis did not reveal significantly greater pre-post improvements in the MBPI group than in the FS group in fertility-related quality of life (difference in differences (DD) = 4.11 [0.42, 7.80], d = 0.32, adjusted P = 0.124), treatment-related quality of life (DD = -3.08 [-7.72, 1.55], d = -0.20, adjusted P = 0.582), infertility-specific stress (DD = -2.54 [-4.68, 0.41], d = -0.36, adjusted P = 0.105), depression (DD = -1.16 [3.61, 1.29], d = -0.13, adjusted P = 0.708), and general stress (DD = -0.62 [-1.91, 0.68], d = -0.13, adjusted P = 0.708), but it did show a significantly larger improvement in trait anxiety (DD = -3.60 [-6.16, -1.04], d = -0.32, adjusted P = 0.042). Logistic regression showed no group effect on MAR pregnancies, spontaneous pregnancies, or live births. LIMITATIONS, REASONS FOR CAUTION: The follow-up only covered MAR-related medical outcomes and no psychological variables, and their rates were not equal in the two groups. Biological factors other than age, aetiology, and duration of infertility may have confounded the study results. Loss to follow-up was between 5% and 10%, which may have led to some bias. WIDER IMPLICATIONS OF THE FINDINGS: The psychologically and medically heterogeneous sample, the normal clinical setting and the low attrition rate all raise the external validity and generalizability of our study. The MBPI works not only in controlled conditions, but also in routine MAR practice, where it can be introduced as a cost-effective, low-intensity psychological intervention, within the framework of stepped care. More studies are needed to further identify its active ingredients. STUDY FUNDING/COMPETING INTEREST(S): The authors received no financial support for the research, authorship, and/or publication of this article. The authors have no conflict of interest to disclose. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT04151485. TRIAL REGISTRATION DATE: 5 November 2019. DATE OF FIRST PATIENT'S ENROLMENT: 15 December 2019.
Assuntos
Infertilidade Feminina , Qualidade de Vida , Técnicas de Reprodução Assistida , Humanos , Feminino , Técnicas de Reprodução Assistida/psicologia , Adulto , Gravidez , Infertilidade Feminina/terapia , Infertilidade Feminina/psicologia , Terapias Mente-Corpo/métodos , Ansiedade/terapia , Ansiedade/psicologia , Saúde Mental , Resultado do Tratamento , Infertilidade/terapia , Infertilidade/psicologia , Taxa de Gravidez , Estresse Psicológico/terapia , Estresse Psicológico/psicologiaRESUMO
To evaluate the impact of perioperative comprehensive nursing intervention on postoperative urinary incontinence, various aspects of patient well-being were assessed. The comprehensive group, that received the nursing intervention, demonstrated significant improvements in self-care skills, health knowledge level, self-care responsibility, and self-concept compared to the standard group. The findings indicate that perioperative comprehensive nursing intervention has a remarkable effect on patients undergoing laparoscopic radical prostatectomy. This nursing intervention not only effectively improves postoperative urinary incontinence and alleviates negative emotions, such as anxiety and depression. Therefore, the implementation of this nursing intervention model is highly recommended for clinical practice and wider application.
Assuntos
Laparoscopia , Prostatectomia , Qualidade de Vida , Incontinência Urinária , Humanos , Prostatectomia/métodos , Prostatectomia/efeitos adversos , Masculino , Incontinência Urinária/psicologia , Incontinência Urinária/etiologia , Incontinência Urinária/prevenção & controle , Pessoa de Meia-Idade , Idoso , Complicações Pós-Operatórias/prevenção & controle , Complicações Pós-Operatórias/etiologia , Neoplasias da Próstata/cirurgia , Neoplasias da Próstata/psicologia , Autocuidado , Assistência Perioperatória/métodosRESUMO
BACKGROUND: Hereditary angioedema (HAE) is a potentially fatal disease characterized by unpredictable, recurrent, often disabling swelling attacks. In a randomized phase 2 study, donidalorsen reduced HAE attack frequency and improved patient quality-of-life (ISIS721744-CS2, NCT04030598). We report the 2-year interim analysis of the phase 2 open-label extension (OLE) study (ISIS 721744-CS3, NCT04307381). METHODS: In the OLE, the on-treatment study period consisted of fixed (weeks 1-13, donidalorsen 80 mg subcutaneously every 4 weeks [Q4W]) and flexible (weeks 17-105, donidalorsen 80 mg Q4W, 80 mg every 8 weeks [Q8W], or 100 mg Q4W) dosing periods. The primary outcome was incidence and severity of treatment-emergent adverse events (TEAEs). The secondary outcomes included efficacy, pharmacodynamic, and quality-of-life assessments. RESULTS: Seventeen patients continued in the OLE study. No serious TEAEs or TEAEs leading to treatment discontinuation were reported. Mean monthly HAE attack rate was 96% lower than the study run-in baseline rate (mean, 0.06/month; 95% confidence interval [CI], 0.02-0.10; median, 0.04 on-treatment vs. mean, 2.70/month; 95% CI, 1.94-3.46; median, 2.29 at baseline). Mean monthly attack rate for Q8W dosing (n = 8) was 0.29 (range, 0.0-1.7; 95% CI, -0.21 to 0.79; median, 0.00). Mean plasma prekallikrein and D-dimer concentrations decreased, and Angioedema Quality of Life Questionnaire total score improved from baseline to week 105 with donidalorsen. CONCLUSION: The 2-year interim results of this phase 2 OLE study of donidalorsen in patients with HAE demonstrated no new safety signals; donidalorsen was well tolerated. There was durable efficacy with a 96% reduction in HAE attacks.
Assuntos
Angioedemas Hereditários , Oligonucleotídeos , Humanos , Angioedemas Hereditários/tratamento farmacológico , Pré-Calicreína , Qualidade de Vida , Resultado do Tratamento , Proteína Inibidora do Complemento C1/uso terapêuticoRESUMO
BACKGROUND: Burnout among providers negatively impacts patient care experiences and safety. Providers at Federally Qualified Health Centers (FQHC) are at high risk for burnout due to high patient volumes; inadequate staffing; and balancing the demands of patients, families, and team members. OBJECTIVE: Examine associations of provider burnout with their perspectives on quality improvement (QI), patient experience measurement, clinic culture, and job satisfaction. DESIGN: We conducted a cross-sectional provider survey about their perspectives including the single-item burnout measure. We fit separate regression models, controlling for provider type, gender, being multilingual, and fixed effects for clinic predicting outcome measures from burnout. PARTICIPANTS: Seventy-four providers from 44 clinics in large, urban FQHC (52% response rate; n = 174). MAIN MEASURES: Survey included a single-item, self-defined burnout measure adapted from the Physician Worklife Survey, and measures from the RAND AMA Study survey, Heath Tracking Physician survey, TransforMed Clinician and Staff Questionnaire, Physician Worklife Survey, Minimizing Errors Maximizing Outcomes survey, and surveys by Friedberg et al. 31 and Walling et al. 32 RESULTS: Thirty percent of providers reported burnout. Providers in clinics with more facilitative leadership reported not being burned out (compared to those reporting burnout; p-values < 0.05). More pressures related to patient care and lower job satisfaction were associated with burnout (p-values < 0.05). CONCLUSIONS: Creating provider-team relationships and environments where providers have the time and space necessary to discuss changes to improve care, ideas are shared, leadership supports QI, and QI is monitored and discussed were related to not being burned out. Reducing time pressures and improving support needed for providers to address the high-need levels of FQHC patients can also decrease burnout. Such leadership and support to improving care may be a separate protective factor against burnout. Research is needed to further examine which aspects of leadership drive down burnout and increase provider involvement in change efforts and improving care.
Assuntos
Esgotamento Profissional , Satisfação no Emprego , Satisfação do Paciente , Melhoria de Qualidade , Humanos , Esgotamento Profissional/psicologia , Esgotamento Profissional/epidemiologia , Masculino , Feminino , Estudos Transversais , Atenção Primária à Saúde/normas , Adulto , Pessoa de Meia-Idade , Cultura Organizacional , Inquéritos e Questionários , Médicos de Atenção Primária/psicologia , Médicos de Atenção Primária/normasRESUMO
BACKGROUND: Women Veterans with co-morbid medical and mental health conditions face persistent barriers accessing high-quality health care. Evidence-based quality improvement (EBQI) offers a systematic approach to implementing new care models that can address care gaps for women Veterans. OBJECTIVE: This study examines factors associated with the successful deployment of EBQI within integrated health systems to improve primary care for women Veterans with complex mental health needs. DESIGN: Following a 12-site (8 EBQI, 4 control) cluster randomized study to evaluate EBQI effectiveness, we conducted an in-depth case study analysis of one women's health clinic that used EBQI to improve integrated primary care-mental health services for women Veterans. PARTICIPANTS: Our study sample included providers, program managers, and clinic staff at a women Veteran's health clinic that, at the time of the study, had one Primary Care and Mental Health Integration team and one women's health primary care provider serving 800 women. We analyzed interviews conducted 12 months, 24 months, and 4 years post-implementation and call summaries between the clinic and support team. MAIN MEASURES: We conducted qualitative thematic analysis of interview and call summary data to identify EBQI elements, clinic characteristics, and reported challenges and successes within project development and execution. KEY RESULTS: The clinic harnessed core EBQI elements (multi-level stakeholder engagement, data-driven progress-monitoring, PDSA cycles, sharing results) to accomplish pre-defined project goals, strengthen inter-disciplinary partnerships, and bolster team confidence. Clinic characteristics that facilitated implementation success included prior QI experience and an organizational culture responsive to innovation, while lack of pre-existing guidelines and limited access to centralized databases posed implementation challenges. CONCLUSIONS: Successful practice transformation emerges through the interaction of evidence-based methods and site-specific characteristics. Examining how clinic characteristics support or impede EBQI adaptation can facilitate efforts to improve care within integrated health systems.