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Background: Acupuncture shows promise as an effective nonpharmacologic option for reduction of acute pain in the emergency department (ED). Following CONSORT and STRICTA guidelines, randomized controlled trials (RCTs) generally report intervention details and acupoint options, but fidelity to acupuncture interventions, critical to reliability in intervention research, is rarely reported. Methods: ACUITY is an NCCIH-funded, multi-site feasibility RCT of acupuncture in 3 EDs (Cleveland, Nashville, and San Diego). ACUITY acupuncturists were trained in study design, responsive acupuncture manualization protocol, logistics and real-time recording of session details via REDCap forms created to track fidelity. Results: Across 3 recruiting sites, 79 participants received acupuncture: 51 % women, 43 % Black/African American, with heterogeneous acute pain sites at baseline: 32 % low back, 22 % extremity, 20 % abdominal, 10 % head. Pragmatically, participants were treated in ED common areas (52 %), private rooms (39 %), and semi-private rooms (9 %). Objective tracking found 98 % adherence to the six components of the acupuncture manualization protocol: staging, number of insertion points (M = 13.2, range 2-22), needle retention time (M = 23.5 min, range 4-52), session length (M = 40.3 min, range 20-66), whether general recommendations were provided and completion of the session form. Conclusion: To the best of our knowledge, this is the first RCT to assess and report fidelity to an acupuncture protocol. Fidelity monitoring will be fundamental for ACUITY2, which would be a future definitive, multi-site RCT. Furthermore, we recommend that fidelity to acupuncture interventions be added to CONSORT and STRICTA reporting guidelines in future RCTs. Protocol registration: The protocol of this study is registered at clinicaltrials.gov: NCT04880733.
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INTRODUCTION: Increasing numbers of women serve in the armed forces in countries worldwide. Stress experienced during pregnancy is associated with adverse birth outcomes including preterm delivery (PTD) and low birth weight (LBW). Several characteristics of military employment and lifestyle can increase stress acting on active-duty servicewomen (ADSW) and hence may increase the risk of adverse neonatal outcomes. This paper reviews the prevalence of PTD, preterm labour (PTL), LBW and stillbirth in babies born to ADSW in the armed forces. METHODS: This systematic review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses protocol. Medline, EMBASE, Web of Science, Global Health and CINAHL Plus databases were searched from inception to July 2021 (November 2023, EMBASE) using subject heading and keyword searches for English language journal articles on babies born to ADSW in any military branch and any country. The Joanna Briggs Institute prevalence critical appraisal tool assessed risk of bias in included papers. Studies were paired with a comparator non-active-duty population to generate a prevalence ratio as the effect measure. A narrative synthesis was conducted. RESULTS: 21 observational studies fulfilled the eligibility criteria. They were all conducted in the US military, involved a total of 650 628 participants, and were published between 1979 and 2023. Their results indicate increased LBW in ADSW compared with non-service women. There was insufficient evidence to conclude or rule out whether ADSW have increased rates of PTD or PTL. CONCLUSIONS: ADSW may be at increased risk of having an LBW baby. However, caution is needed if seeking to generalise the findings beyond the US context. This review highlights a growing need for female-specific research in other armed forces and, specifically, into reproductive health. Such research is necessary to inform military maternity pathways and policies in ways that safeguard mothers and their babies while enhancing military readiness.
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Guinea fowl eggshells have an unusual structural arrangement that is different from that of most birds, consisting of two distinct layers with different microstructures. This bilayered organization, and distinct microstructural characteristics, provides it with exceptional mechanical properties. The inner layer, constituting about one third of the eggshell thickness, contains columnar calcite crystal units arranged vertically as in most bird shells. However, the thicker outer layer has a more complex microstructural arrangement formed by a switch to smaller calcite domains with diffuse/interlocking boundaries, partly resembling the interfaces seen in mollusk shell nacre. The switching process that leads to this remarkable second-layer microstructure is unknown. Our results indicate that the microstructural switching is triggered by changes in the inter- and intracrystalline organic matrix. During production of the outer microcrystalline layer in the later stages of eggshell formation, the interactions of organic matter with mineral induce an accumulation of defects that increase crystal mosaicity, instill anisotropic lattice distortions in the calcite structure, interrupt epitaxial growth, reduce crystallite size, and induce nucleation events which increase crystal misorientation. These structural changes, together with the transition between the layers and each layer having different microstructures, enhance the overall mechanical strength of the Guinea fowl eggshell. Additionally, our findings provide new insights into how biogenic calcite growth may be regulated to impart unique functional properties. STATEMENT OF SIGNIFICANCE: Avian eggshells are mineralized to protect the embryo and to provide calcium for embryonic chick skeletal development. Their thickness, structure and mechanical properties have evolved to resist external forces throughout brooding, yet ultimately allow them to crack open during chick hatching. One particular eggshell, that of the Guinea fowl, has structural features very different from other galliform birds - it is bilayered, with an inner columnar mineral structure (like in most birds), but it also has an outer layer with a complex microstructure which contributes to its superior mechanical properties. This work provides novel and new fundamental information about the processes and mechanisms that control and change crystal growth during the switch to microcrystalline domains when the second outer layer forms.
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Galinhas , Casca de Ovo , Animais , Casca de Ovo/química , Carbonato de Cálcio/química , MineraisRESUMO
BACKGROUND: Prevalence of intellectual disability (ID) is currently estimated through parent report on surveys of children. It is difficult to estimate the number of adults living with ID in the United States because no comprehensive survey or surveillance allows for identification. The purpose of this study was to estimate the prevalence and number of adults with ID born between 1980 and 1999 using multiple years of the National Health Interview Survey (NHIS) and Census data. METHODS: We concatenated the NHIS from 1997-2016 that evaluated parental response about whether a child aged 3-17 years had an ID. Using weighted survey analyses, we estimated the prevalence of ID among individuals across four birth cohorts-(1) 1980-1984, (2) 1985-1989, (3) 1990-1994, and (4) 1995-1999. The number of adults with ID was then extrapolated by applying these prevalence rates to Census population estimates (as of 1 July 2021) of respective birth cohorts. RESULTS: Weighted prevalence of ID varied by birth cohort, sex, race and ethnicity, and US Census Bureau regions. The overall prevalence rate was 1.066 [95% confidence interval (CI): 0.831-1.302] for adults born between 1980 and 1984, 0.772 (CI: 0.654-0.891) for adults born between 1985 and 1989, 0.774 (0.675-0.874) for adults born between 1990 and 1994, and 1.069 (CI: 0.898-1.240) for adults born between 1995 and 1999. Overall, we estimate that 818 564 adults with ID who were approximately 21-41 years were living in the United States as of 2021. CONCLUSIONS: This study provides researchers examining adult health outcomes with an estimated denominator of young and middle-aged adults living with ID in the United States. Policymakers can use this information to support justification for resource and service needs, and clinicians may benefit from understanding that ID is a lifelong developmental condition often with additional physical, emotional and developmental needs requiring tailored care.
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Deficiência Intelectual , Vigilância da População , Criança , Adulto , Pessoa de Meia-Idade , Humanos , Estados Unidos/epidemiologia , Prevalência , Deficiência Intelectual/epidemiologia , Inquéritos e Questionários , EtnicidadeRESUMO
Background: Acupuncture and yoga have both been shown to be effective in chronic pain. Underrepresented populations have poorer pain outcomes with less access to effective pain care. Objective: To assess the feasibility of bundling group acupuncture with yoga therapy for chronic neck, back or osteoarthritis pain in safety net settings. Methods: This was a feasibility pilot in Bronx and Harlem primary care community health centers. Participants with chronic neck, back or osteoarthritis pain received acupuncture and yoga therapy over a 10-week period. Participants received 10 weekly acupuncture treatments in group setting; with Yoga therapy sessions beginning immediately following the 3rd session. Primary outcome was pain interference and pain intensity on the Brief Pain Inventory (BPI); Outcomes were measured at baseline, 10-week close of intervention, and 24-week follow-up. Results: 93 patients were determined to be eligible and completed the baseline interview. The majority of participants were non-White and Medicaid recipients. 78 (84%) completed the intervention and 10-week survey, and 58 (62%) completed the 24-week post intervention survey. Participants received an average number of 6.5 acupuncture sessions (out of a possible 10), and 4 yoga sessions (out of a possible 8) over the 10-week intervention. Patients showed statistically significant improvements in pain at the close of the intervention and at a somewhat lesser rate, at 24-weeks post intervention. Challenges included telephone outreach and site coordination integrating acupuncture with yoga therapy. The trial also had to be stopped early due to the COVID-19 pandemic. Conclusions: Bundling acupuncture therapy and yoga therapy is feasible for an underrepresented population with chronic pain in urban community health centers with preliminary indications of acceptability and benefit to participants.
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OBJECTIVES: Since Russia's full-scale invasion of Ukraine on 24 February 2022, millions of people have fled the country. Most people have gone to the neighbouring countries of Poland, Slovakia, Hungary, Romania, and Moldova. This vulnerable population has significant healthcare needs. Among the most challenging to address will be chronic non-communicable diseases (NCDs), including mental disorders, as these require long-term, continuous care and access to medicines. Host country health systems are faced with the challenge of ensuring accessible and affordable care for NCDs and mental disorders to this population. Our objectives were to review host country health system experiences and identify priorities for research to inform sustainable health system responses to the health care needs of refugees from Ukraine. STUDY DESIGN: In-person conference workshop. METHODS: A workshop on this subject was held in November 2022 at the European Public Health Conference in Berlin. RESULTS: The workshop included participants from academia and non-governmental organisations, health practitioners, and World Health Organisation regional and country offices. This short communication reports the main conclusions from the workshop. CONCLUSION: Addressing the challenges and research priorities identified will require international solidarity and co-operation.
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Refugiados , Humanos , Atenção à Saúde , Polônia , Hungria , RomêniaRESUMO
BACKGROUND/AIMS: We present and describe recruitment strategies implemented from 2013 to 2017 across 45 clinical sites in the United States, participating in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study, an unmasked, randomized controlled trial evaluating four glucose-lowering medications added to metformin in individuals with type 2 diabetes mellitus (duration of diabetes <10 years). We examined the yield of participants recruited through Electronic Health Records systems compared to traditional recruitment methods to leverage access to type 2 diabetes patients in primary care. METHODS: Site selection criteria included availability of the study population, geographic representation, the ability to recruit and retain a diverse pool of participants including traditionally underrepresented groups, and prior site research experience in diabetes clinical trials. Recruitment initiatives were employed to support and monitor recruitment, such as creation of a Recruitment and Retention Committee, development of criteria for Electronic Health Record systems queries, conduct of remote site visits, development of a public screening website, and other central and local initiatives. Notably, the study supported a dedicated recruitment coordinator at each site to manage local recruitment and facilitate screening of potential participants identified by Electronic Health Record systems. RESULTS: The study achieved the enrollment goal of 5000 participants, meeting its target with Black/African American (20%), Hispanic/Latino (18%), and age â§60 years (42%) subgroups but not with women (36%). Recruitment required 1 year more than the 3 years originally planned. Sites included academic hospitals, integrated health systems, and Veterans Affairs Medical Centers. Participants were enrolled through Electronic Health Record queries (68%), physician referral (13%), traditional mail outreach (7%), TV, radio, flyers, and Internet (7%), and other strategies (5%). Early implementation of targeted Electronic Health Record queries yielded a greater number of eligible participants compared to other recruitment methods. Efforts over time increasingly emphasized engagement with primary care networks. CONCLUSION: Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness successfully recruited a diverse study population with relatively new onset of type 2 diabetes mellitus, relying to a large extent on the use of Electronic Health Record to screen potential participants. A comprehensive approach to recruitment with frequent monitoring was critical to meet the recruitment goal.
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Diabetes Mellitus Tipo 2 , Metformina , Humanos , Feminino , Pessoa de Meia-Idade , Diabetes Mellitus Tipo 2/prevenção & controle , Seleção de PacientesRESUMO
PURPOSE: Tumor-infiltrating lymphocytes (TILs) have been positively correlated with response to systemic therapy for triple-negative and HER2 + subtypes and improved clinical outcomes in early breast cancer (BC). Less is known about TILs in metastatic sites, particularly brain metastases (BM), where unique immune regulation governs stromal composition. Reactive glial cells actively participate in cytokine-mediated T cell stimulation. The impact of prior medical therapy (chemotherapy, endocrine, and HER2-targeted therapy) on the presence of TILs and gliosis in human breast cancer brain metastases (BCBM) has not been previously reported. METHODS: We examined prior treatment data for 133 patients who underwent craniotomy for resection of BMs from the electronic medical record. The primary endpoint was overall survival (OS) from the time of BM diagnosis. We examined the relationship between prior systemic therapy exposure and the histologic features of gliosis, necrosis, hemorrhage, and lymphocyte infiltration (LI) in BCBMs resected at subsequent craniotomy in univariate analyses. RESULTS: Complete treatment data were available for 123 patients. BCBM LI was identified in 35 of 116 (30%) patients who had received prior systemic treatment versus 5 of 7 (71.4%) who had not {significant by Fisher's exact test p = 0.045}. There were no statistically significant relationships between prior systemic therapy and the three other histologic variables examined. CONCLUSIONS: This observation suggests that systemic therapy may interfere with the immune response to BCBMs and cause exhaustion of anti-tumor immunity. This motivates clinical investigation of strategies to enhance LI for therapeutic benefit to improve outcomes for patients with BCBMs.
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Neoplasias Encefálicas , Neoplasias da Mama , Humanos , Feminino , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/cirurgia , Prognóstico , Gliose/patologia , Linfócitos do Interstício Tumoral , Neoplasias Encefálicas/tratamento farmacológico , Neoplasias Encefálicas/cirurgia , Receptor ErbB-2RESUMO
BACKGROUND: To achieve WHO targets for the elimination of hepatitis C virus (HCV) as a public threat, an increased uptake of HCV treatment among people who inject drugs (PWID) is urgently needed. Optimal HCV co-located treatment models for PWID have not yet been identified. We aimed to compare two patient-centred models of HCV care in PWID with active drug use. METHODS: We did a pragmatic randomised controlled trial at eight US cities in eight opioid treatment programmes and 15 community health centres. PWID actively injecting within 90 days of study entry were randomly assigned (1:1) to either patient navigation or modified directly observed therapy (mDOT) using computer-generated variable block sizes of 2-6 stratified by city, clinical settings, and cirrhosis status. The randomisation code was concealed, in a centralised REDCap database platform, from all investigators and research staff except for an authorised data manager at the data coordinating centre. All participants received a fixed-dose combination tablet (sofosbuvir 400 mg plus velpatasvir 100 mg) orally once daily for 12 weeks. The primary outcome was sustained virological response (SVR; determined by chart review between 70 days and 365 days after end of treatment and if unavailable, by study blood draws), and secondary outcomes were treatment initiation, adherence (measured by electronic blister packs), and treatment completion. Analyses were conducted within the modified intention-to-treat (mITT; all who initiated treatment), intention-to-treat (all who were randomised), and per-protocol populations. This trial is registered with ClinicalTrials.gov, NCT02824640. FINDINGS: Between Sept 15, 2016, and Aug 14, 2018, 1891 individuals were screened and 1136 were excluded (213 declined to participate and 923 did not meet the eligibility criteria). We randomly assigned 755 participants to patient navigation (n=379) or mDOT (n=376). In the mITT sample of participants who were randomised and initiated treatment (n=623), 226 (74% [95% CI 69-79]) of 306 participants in the mDOT group and 236 (76% [69-79]) of 317 in the patient navigation group had an SVR, with no significant difference between the groups (adjusted odds ratio [AOR] 0·97 [95% CI 0·66-1·42]; p=0·35). In the ITT sample (n=755), 226 (60% [95% CI 55-65]) of 376 participants in the mDOT group and 236 (62% [57-67]) of 379 in the patient navigation group had an SVR (AOR 0·92 [0·68-1·25]; p=0·61) and in the per-protocol sample (n=501), 226 (91% [87-94]) of 248 participants in the mDOT group and 235 (93% [89-96]) of 253 in the patient navigation group had an SVR (AOR 0·79 [0·41-1·55]; p=0·44). 306 (81%) of 376 participants in the mDOT group and 317 (84%) of 379 participants in the patient navigation group initiated treatment (AOR 0·86 [0·58-1·26]; p=0·44) and, among those, 251 (82%) participants in the mDOT group and 264 (83%) participants in the patient navigation group completed treatment (AOR 0·90 [0·58-1·39]; p=0·63). Mean daily adherence was higher in the mDOT group (78% [95% CI 75-81]) versus the patient navigation group (73% [70-77]), with a difference of 4·7% ([1·9-7·4]; p=0·0010). 421 serious adverse events were reported (217 in the mDOT group and 204 in the patient navigation group), with the most common being hospital admission (176 in the mDOT group vs 161 in the patient navigation group). INTERPRETATION: In this trial of active PWID, both models resulted in high SVR. Although adherence was significantly higher in the mDOT group versus the patient navigation group, there was no significant difference in SVR between the groups. Increases in adherence and treatment completion were associated with an increased likelihood of SVR. These results suggest that active PWID can reach high SVRs in diverse settings with either mDOT or patient navigation support. FUNDING: Patient-Centered Outcomes Research Institute, Gilead Sciences, Quest Diagnostics, Monogram Biosciences, and OraSure Technologies.
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Usuários de Drogas , Hepatite C , Abuso de Substâncias por Via Intravenosa , Humanos , Abuso de Substâncias por Via Intravenosa/complicações , Abuso de Substâncias por Via Intravenosa/tratamento farmacológico , Antivirais/efeitos adversos , Sofosbuvir/uso terapêutico , Hepatite C/tratamento farmacológico , Hepatite C/complicações , HepacivirusRESUMO
OBJECTIVE: To evaluate the real-world effectiveness of integrative medicine treatment on quality of life using the Patients Receiving Integrative Medicine Effectiveness Registry (PRIMIER). DESIGN: A prospective, longitudinal, observational evaluation of patient reported outcomes for quality of life. SETTING: Participants were patients from 17 integrative medicine clinics who received personalized, integrative medicine treatments between August 2013 and October 2017. MAIN OUTCOME MEASURES: Participants completed the Patient Reported Outcomes Measurement Information System (PROMIS)- 29, Perceived Stress Scale-4 (PSS-4), and the Patient Activation Measure (PAM) at index (baseline) visit and at 2, 4, 6, and 12 month follow-up assessments. Electronic health record data included diagnostic and billing codes/descriptions. A linear mixed-effects model was used to test whether outcomes changed from index through 12 months RESULTS: During enrollment, 4883 participants began the assessment, 3658 completed the index measures, and 2374 (65 %) completed at least 1 follow-up assessment, had electronic health record data and at least 1 integrative medicine visit. Most participants (mean age=51.4 years) were white (88.4 %), female (79.7 %), and college-educated (78.5 %). Significant improvements (p < 0.001) were observed at 12-months on all PROMIS-29 measures, PSS-4, and PAM. At 12 months, clinically meaningful improvements were found for 38 % and 28 % on PROMIS-29 Mental and Physical Health Summary scores respectively. CONCLUSIONS: PRIMIER is the largest study to assess the real-world effectiveness of integrative medicine. Results indicate a statistical and clinical improvement across all measures at 12 months. Future research could explore whether dosing, timing or combinations of integrative medicine interventions have differential impacts on quality of life.
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Medicina Integrativa , Humanos , Feminino , Pessoa de Meia-Idade , Qualidade de Vida , Estudos Prospectivos , Medidas de Resultados Relatados pelo Paciente , PacientesRESUMO
INTRODUCTION: Achieving optimal control of blood pressure is easier when those affected understand the risks and consequences of hypertension and the principles of management. It is particularly important in disadvantaged groups among whom blood pressure control is often poor. However, effective responses require evidence of the knowledge and beliefs of those affected. This was undertaken as part of a larger study of the therapeutic journeys followed by individuals living in B40 (bottom 40% by income) households in Malaysia, the Responsive and Equitable Health Systems-Partnership on Non- Communicable Diseases (RESPOND).This paper describes their reported knowledge of hypertension, health, and measures that can improve hypertensive control. MATERIALS AND METHODS: The communities were selected from rural and urban populations in four peninsular states (Selangor, Kelantan, Perak, and Johor). Following a multistage sampling approach, communities in each stratum were selected according to probability proportional to the size and identified based on national census data by the community and administrative registers. Households were randomly selected. Eligible individuals were those aged between 35 and 70 years old, self-reported or identified as hypertensive at screening. Informed consent was taken. A survey using validated questionnaires was conducted. RESULTS: The total number of respondents was 579. The mean age was 59.0 (95%: 58.4, 59.7) and more were women (71.5%) than men (28.5%). Regarding respondents selfreported level of hypertension knowledge, 2.9% reported having no knowledge at all, 80.1% had little knowledge, and 17.9% were very familiar. Among all respondents, 56.2% (95% CI: 50.7, 61.6) correctly answered at least four out of five objective knowledge questions.Almost all (91.5%) were aware that hypertension could cause a stroke. However, one-fifth believed it could cause cancer. Almost threequarters said that people with high blood pressure generally felt well (72.1%) and recognized that they should not stop taking their medication (70.7%). Most of the respondents knew that people should take their medication even if they feel well (73.6%). Although more than half (66.0%) of the respondents rated their health as poor. Interestingly, most did not perceive themselves as having a long-term illness (95.0%). CONCLUSION: This study provides reassurance that individuals with hypertension in disadvantaged communities in Malaysia have a relatively good understanding of hypertension. Further research should explore the challenges they face on their therapeutic journeys.
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Hipertensão , Adulto , Idoso , Pressão Sanguínea/fisiologia , Feminino , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Hipertensão/epidemiologia , Hipertensão/terapia , Malásia/epidemiologia , Masculino , Pessoa de Meia-Idade , População Rural , Inquéritos e QuestionáriosRESUMO
INTRODUCTION: Increasingly, people who inject drugs (PWID) infected with hepatitis C virus (HCV) are gaining access to highly effective direct-acting antiviral agents (DAAs). Although past studies examined patient experiences with interferon-based treatments, few have explored patient experiences with these new generation therapeutics. Research and real world experience indicate that many PWID can be successfully treated with the new DAAs. Yet a substantial minority fail to complete treatment or achieve only suboptimal adherence. This qualitative study examines experiences with treatment among participants in Project HERO, a large multisite trial designed to compare treatment delivery methods for DAAs. We explored treatment experiences among HERO participants, with the goal of understanding potential barriers to treatment engagement and completion. METHODS: We conducted qualitative interviews with a sample of 21 participants, including 14 who completed HCV treatment and 7 participants who discontinued treatment before the end of the 12-week medication course. The first phase of the analysis was descriptive, examining participants' life experiences, histories of disease and treatment seeking, experiences with the program, and barriers to treatment completion. The second phase of the analysis examined differences between completers and noncompleters. RESULTS: Participants offered a variety of reasons for seeking treatment. Both groups of participants reported highly positive experiences of the HERO trial. Participants described research staff as caring, respectful, and nonjudgmental. Substance use was reported by both groups, yet completers described "manageable" substance use, while noncompleters described substance use that sapped their energy and motivation. Shame over drug use was a barrier to treatment completion. Homelessness and a reported lack of social support were much more common in the noncompleter group. CONCLUSIONS: Reasons for noncompletion were not related to features of the clinical trial or treatment program. Our results indicate the importance of: 1) recognizing and addressing severe social and economic challenges such as homelessness; and 2) building a program culture of respect and compassion in treatment programs for PWID infected with HCV.
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Usuários de Drogas , Hepatite C Crônica , Hepatite C , Abuso de Substâncias por Via Intravenosa , Antivirais/uso terapêutico , Hepacivirus , Hepatite C/tratamento farmacológico , Hepatite C Crônica/tratamento farmacológico , Humanos , Preparações Farmacêuticas , Abuso de Substâncias por Via Intravenosa/tratamento farmacológicoRESUMO
PURPOSE: Pain accounts for up to 78% of emergency department (ED) patient visits and opioids remain a primary method of treatment despite risks of addiction and adverse effects. While prior acupuncture studies are promising as an alternative opioid-sparing approach to pain reduction, successful conduct of a multi-center pilot study is needed to prepare for a future definitive randomized control trial (RCT). METHODS: Acupuncture in the Emergency Department for Pain Management (ACUITY) is funded by the National Center for Complementary and Integrative Health. The objectives are to: conduct a multi-center feasibility RCT, examine feasibility of data collection, develop/deploy a manualized acupuncture intervention and assess feasibility/implementation (barrier/facilitators) in 3 EDs affiliated with the BraveNet Practice Based Research Network.Adults presenting to a recruiting ED with acute non-emergent pain (e.g., musculoskeletal, back, pelvic, noncardiac chest, abdominal, flank or head) of ≥4 on a 0-10-point Numeric Rating Scale will be eligible. ED participants (nâ=â165) will be equally randomized to Acupuncture or Usual Care.At pre-, post-, and discharge time-points, patients will self-assess pain and anxiety using the Numeric Rating Scale. Pain, anxiety, post-ED opioid use and adverse events will be assessed at 1 and 4âweeks. Opioid utilization in the ED and discharge prescriptions will be extracted from patients' electronic medical records.Acupuncture recipients will asked to participate in a brief qualitative interview about 3âweeks after their discharge. ED providers and staff will also be interviewed about their general perspectives/experiences related to acupuncture in the ED and implementation of acupuncture in ACUITY. RESULTS: Recruitment began on 5/3/21. As of 12/7/21: 84 patients have enrolled, the responsive acupuncture intervention has been developed and deployed, and 26 qualitative interviews have been conducted. CONCLUSION: Successful conduct of ACUITY will provide the necessary framework for conducting a future, multi-center, definitive RCT of acupuncture in the ED. CLINICAL TRIALSGOV: NCT04880733 https://clinicaltrials.gov/ct2/show/NCT04880733.
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Terapia por Acupuntura/estatística & dados numéricos , Dor Aguda/terapia , Serviço Hospitalar de Emergência , Manejo da Dor , Terapia por Acupuntura/métodos , Estudos de Viabilidade , Humanos , Estudos Multicêntricos como Assunto , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
There are currently screening programmes for breast, cervical and colorectal cancer in many European countries. However, the uptake of cancer screening in general may vary within and between countries. The aim of this study is to assess the inequalities in testing utilization by socio-economic status and whether the amount of inequality varies across European regions. We conducted an analysis based on cross-sectional data from the second wave of the European Health Interview Survey from 2013 to 2015. We analysed the use of breast, cervical, and colorectal cancer testing by socio-economic position (household income, educational level and employment status), socio-demographic factors, self-perceived health and smoking behaviour, by using multinomial logistic models, and inequality measurement based on the Slope index of inequality (SII) and Relative index of inequality (RII). The results show that the utilization of mammography (Odds Ratio (OR) = 0.55, 95% confidence interval (95%CI):0.50-0.61), cervical smear tests (OR = 0.60, 95%CI:0.56-0.65) and colorectal testing (OR = 0.82, 95%CI:0.78-0.86) was overall less likely among individuals within a low household income compared to a high household income. Also, individuals with a non-EU country of birth, low educational level and being unemployed (or retired) were overall less likely to be tested. The income-based inequality in breast (SII = 0.191;RII = 1.260) and colorectal testing utilization (SII = 0.161;RII = 1.487) was the greatest in Southern Europe. For cervical smears, this inequality was greatest in Eastern Europe (SII = 0.122;RII = 1.195). We concluded that there is considerable inequality in the use of cancer tests in Europe, with inequalities associated with household income, educational level, employment status, and country of birth.
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BACKGROUND: Black and Latinx patients bear a disproportionate burden of asthma. Efforts to reduce the disproportionate morbidity have been mostly unsuccessful, and guideline recommendations have not been based on studies in these populations. METHODS: In this pragmatic, open-label trial, we randomly assigned Black and Latinx adults with moderate-to-severe asthma to use a patient-activated, reliever-triggered inhaled glucocorticoid strategy (beclomethasone dipropionate, 80 µg) plus usual care (intervention) or to continue usual care. Participants had one instructional visit followed by 15 monthly questionnaires. The primary end point was the annualized rate of severe asthma exacerbations. Secondary end points included monthly asthma control as measured with the Asthma Control Test (ACT; range, 5 [poor] to 25 [complete control]), quality of life as measured with the Asthma Symptom Utility Index (ASUI; range, 0 to 1, with lower scores indicating greater impairment), and participant-reported missed days of work, school, or usual activities. Safety was also assessed. RESULTS: Of 1201 adults (603 Black and 598 Latinx), 600 were assigned to the intervention group and 601 to the usual-care group. The annualized rate of severe asthma exacerbations was 0.69 (95% confidence interval [CI], 0.61 to 0.78) in the intervention group and 0.82 (95% CI, 0.73 to 0.92) in the usual-care group (hazard ratio, 0.85; 95% CI, 0.72 to 0.999; P = 0.048). ACT scores increased by 3.4 points (95% CI, 3.1 to 3.6) in the intervention group and by 2.5 points (95% CI, 2.3 to 2.8) in the usual-care group (difference, 0.9; 95% CI, 0.5 to 1.2); ASUI scores increased by 0.12 points (95% CI, 0.11 to 0.13) and 0.08 points (95% CI, 0.07 to 0.09), respectively (difference, 0.04; 95% CI, 0.02 to 0.05). The annualized rate of missed days was 13.4 in the intervention group and 16.8 in the usual-care group (rate ratio, 0.80; 95% CI, 0.67 to 0.95). Serious adverse events occurred in 12.2% of the participants, with an even distribution between the groups. CONCLUSIONS: Among Black and Latinx adults with moderate-to-severe asthma, provision of an inhaled glucocorticoid and one-time instruction on its use, added to usual care, led to a lower rate of severe asthma exacerbations. (Funded by the Patient-Centered Outcomes Research Institute and others; PREPARE ClinicalTrials.gov number, NCT02995733.).
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Antiasmáticos , Asma , Beclometasona , Negro ou Afro-Americano , Glucocorticoides , Hispânico ou Latino , Administração por Inalação , Adulto , Antiasmáticos/administração & dosagem , Antiasmáticos/efeitos adversos , Antiasmáticos/uso terapêutico , Asma/tratamento farmacológico , Asma/etnologia , Beclometasona/administração & dosagem , Beclometasona/efeitos adversos , Beclometasona/uso terapêutico , Glucocorticoides/administração & dosagem , Glucocorticoides/efeitos adversos , Glucocorticoides/uso terapêutico , Humanos , Qualidade de Vida , Inquéritos e Questionários , Exacerbação dos SintomasRESUMO
AIMS: We evaluated differences in participants with type 2 diabetes (T2DM) enrolled in the GRADE study at VA vs non-VA sites, focusing on cardiovascular risk factors and rates of diabetes care target achievements. METHODS: We compared baseline characteristics between participants at VA (n = 1216) and non-VA (n = 3831) sites, stratifying analyses by cardiovascular disease (CVD) history. RESULTS: VA and non-VA participants had similar diabetes duration (4.0 years), HbA1c (7.5%), and BMI (34 kg/m2); however, VA participants had more individuals ≥ 65 years (37.3% vs 19.8%, p < 0.001), men (90.0% vs 55.2%, p < 0.001), hypertension (75.8% vs 63.6%, p < 0.001), hyperlipidemia (76.6% vs 64.6%, p < 0.001), current smokers (19.0% vs 12.1%, p < 0.001), nephropathy (20.4% vs 17.0%, p < 0.05), albuminuria (18.4% vs 15.1%, p < 0.05), and CVD (10.4% vs 5.2%, p < 0.001). In those without CVD, more VA participants were treated with lipid (70.8% vs 59.5%, p < 0.001) and blood pressure (74.9% vs 65.4%, p < 0.001) lowering medications, and had LDL-C < 70 mg/dl (32.9% vs 24.2%, p < 0.05). Among those with CVD, more VA participants had BP < 140/90 (80.2% vs 70.1%, p < 0.05) after adjusting for demographics. CONCLUSION: GRADE participants at VA sites had more T2DM complications, greater CVD risk and were more likely to be treated with medications to reduce it, leading to more LDL-C at goal than non-VA participants, highlighting differences in diabetes populations and care.
Assuntos
Doenças Cardiovasculares , Diabetes Mellitus Tipo 2 , Veteranos , Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/etiologia , Doenças Cardiovasculares/prevenção & controle , Diabetes Mellitus Tipo 2/tratamento farmacológico , Fatores de Risco de Doenças Cardíacas , Humanos , Masculino , Fatores de RiscoRESUMO
BACKGROUND: After hospital discharge, patients can experience symptoms prompting them to seek acute medical attention. Early evaluation of patients' post-discharge symptoms by healthcare providers may improve appropriate healthcare utilization and patient safety. Post-discharge follow-up phone calls, which are used for routine transitional care in U.S. hospitals, serve as an important channel for provider-patient communication about symptoms. This study aimed to assess the facilitators and barriers to evaluating and triaging pain symptoms in cardiovascular patients through follow-up phone calls after their discharge from a large healthcare system in Central Massachusetts. We also discuss strategies that may help address the identified barriers. METHODS: Guided by the Practical, Robust, Implementation and Sustainability Model (PRISM), we completed semi-structured interviews with 7 nurses and 16 patients in 2020. Selected nurses conducted (or supervised) post-discharge follow-up calls on behalf of 5 clinical teams (2 primary care; 3 cardiology). We used thematic analysis to identify themes from interviews and mapped them to the domains of the PRISM model. RESULTS: Participants described common facilitators and barriers related to the four domains of PRISM: Intervention (I), Recipients (R), Implementation and Sustainability Infrastructure (ISI), and External Environment (EE). Facilitators include: (1) patients being willing to receive provider follow-up (R); (2) nurses experienced in symptom assessment (R); (3) good care coordination within individual clinical teams (R); (4) electronic health record system and call templates to support follow-up calls (ISI); and (5) national and institutional policies to support post-discharge follow-up (EE). Barriers include: (1) limitations of conducting symptom assessment by provider-initiated follow-up calls (I); (2) difficulty connecting patients and providers in a timely manner (R); (3) suboptimal coordination for transitional care among primary care and cardiology providers (R); and (4) lack of emphasis on post-discharge follow-up call reimbursement among cardiology clinics (EE). Specific barriers for pain assessment include: (1) concerns with pain medication misuse (R); and (2) no standardized pain assessment and triage protocol (ISI). CONCLUSIONS: Strategies to empower patients, facilitate timely patient-provider communication, and support care coordination regarding pain evaluation and treatment may reduce the barriers and improve processes and outcomes of pain assessment and triage.
Assuntos
Enfermeiras e Enfermeiros , Alta do Paciente , Assistência ao Convalescente , Humanos , Medição da Dor , Pesquisa Qualitativa , TriagemRESUMO
Diabetic foot amputation is a preventable complication that is increasing in incidence in the United States, with disparities across geography, race, ethnicity, and income. This qualitative study explored the experiences of people in a low-income urban area in the United States in preventing and obtaining care for foot ulcers. Sixteen adults with foot ulcers were identified through purposive sampling based on records of hospital stays and primary care visits. Semi-structured interviews were transcribed and analyzed for key themes. Participants described inadequate understanding of diabetic foot disease: many sought care only after developing advanced symptoms. They identified social and health system factors as barriers to timely access to care. Some participants described a realization of the seriousness of their condition and an ability to improve self-care after developing an ulcer. Patients' experiences can inform the design of amputation-reduction initiatives to achieve more desirable results, including enhanced self-management capabilities, timely access, and attention to social determinants.
Assuntos
Diabetes Mellitus , Pé Diabético , Adulto , Amputação Cirúrgica , Pé Diabético/prevenção & controle , Humanos , Pesquisa Qualitativa , Autocuidado , Estados Unidos/epidemiologia , População UrbanaRESUMO
While extensive literature exists on barriers and strategies to increase minority participation in clinical trials, progress is limited. Few strategies were evaluated in randomized trials. We studied the impact of RECRUIT, a trust-based, cluster randomized minority recruitment trial layered on top of four traditional NIH-funded parent trials (BMT CTN, CABANA, PACES, STEADY-PD III; fifty specialty sites). RECRUIT was conducted from July 2013 through April 2017. Intervention sites implemented trust-based approaches customized to individual sites, promoting relationships between physician-investigators and minority-serving physicians and their minority patients. Control sites implemented only parent trials' recruitment procedures. Adjusting for within-site clustering, we detected no overall intervention effect, odds ratio 1.3 (95% confidence limits 0.7,2.4). Heterogeneity among parent trials may have obscured the effect. Of the four parent trials, three enrolled more minorities in intervention versus control sites. CABANA odds ratio = 4.2 (adjusted 95%CL 1.5,11.3). PACES intervention sites enrolled 63% (10/16) minorities; control sites enrolled one participant in total, a minority, yielding an incalculable odds ratio. STEADY-PD III odds ratio = 2.2 (adjusted 95%CL 0.6,8.5). BMT CTN odds ratio < 1, 0.8 (adjusted 95%CL 0.4,1.8). In conclusion, RECRUIT findings suggest the unique trust-based intervention increased minority recruitment to intervention trials in ¾ of studied trials. Physician-investigators' participation was critical to recruitment success. Lack of commitment to minority recruitment remained a barrier for some physician-investigators, especially in control sites. We recommend prospective physician investigators commit to minority recruitment activities prior to selection as site investigators and trial funding include some compensation for minority recruitment efforts. TRIAL REGISTRATION ClinicalTrials.govNCT01911208.