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1.
HEC Forum ; 2023 Jul 10.
Article in English | MEDLINE | ID: mdl-37428252

ABSTRACT

Moral distress is a well-documented phenomenon for health care providers (HCPs). Exploring HCPs' perceptions of participation in moral distress interventions using qualitative and quantitative methods enhances understanding of intervention effectiveness. The purpose of this study was to measure and describe the impact of a two-phased intervention on participants' moral distress. Using a cross-over design, the project aimed to determine if the intervention would decrease moral distress, enhance moral agency, and improve perceptions about the work environment. We used quantitative instruments and explored participants' perceptions of the intervention using semi-structured interviews. Participants were from inpatient settings, within three major hospitals of a large, urban healthcare system in the Midwest, United States. Participants included nurses (80.6%) and other clinical care providers. Using generalized linear mixed modeling we assessed the change in each of the outcome variables over time controlling for groups. Interviews were audiotaped and professionally transcribed. The written narratives were coded into themes. The change in scores on study instruments trended in the desired direction however did not meet statistical significance. Qualitative interviews revealed that intervention effectiveness was derived from a combination of learning benefits, psychological benefits, and building community that promoted moral agency. Findings demonstrate a clear link between moral distress and moral agency and suggest that Facilitated Ethics Conversations can enhance the work environment. Findings provide insight for developing evidenced-based approaches to address moral distress of hospital nurses.

2.
Sex Transm Dis ; 49(1): 67-75, 2022 01 01.
Article in English | MEDLINE | ID: mdl-34618416

ABSTRACT

BACKGROUND: In men with nongonococcal urethritis (NGU), clinicians and patients rely on clinical cure to guide the need for additional testing/treatment and when to resume sex, respectively; however, discordant clinical and microbiological cure outcomes do occur. How accurately clinical cure reflects microbiological cure in specific sexually transmitted infections (STIs) is unclear. METHODS: Men with NGU were tested for Neisseria gonorrhoeae, Chlamydia trachomatis (CT), Mycoplasma genitalium (MG), Trichomonas vaginalis, urethrotropic Neisseria meningitidis ST-11 clade strains, and Ureaplasma urealyticum (UU). Men received azithromycin 1 g and returned for a 1-month test-of-cure visit. In MG infections, we evaluated for the presence of macrolide resistance-mediating mutations (MRMs) and investigated alternate hypotheses for microbiological treatment failure using in situ shotgun metagenomic sequencing, phylogenetic analysis, multilocus sequence typing analyses, and quantitative PCR. RESULTS: Of 280 men with NGU, 121 were included in this analysis. In the monoinfection group, 52 had CT, 16 had MG, 7 had UU, 10 had mixed infection, and 36 men had idiopathic NGU. Clinical cure rates were 85% for CT, 100% for UU, 50% for MG, and 67% for idiopathic NGU. Clinical cure accurately predicted microbiological cure for all STIs, except MG. Discordant results were significantly associated with MG-NGU and predominantly reflected microbiological failure in men with clinical cure. Mycoplasma genitalium MRMs, but not MG load or strain, were strongly associated with microbiological failure. CONCLUSIONS: In azithromycin-treated NGU, clinical cure predicts microbiological cure for all STIs, except MG. Nongonococcal urethritis management should include MG testing and confirmation of microbiological cure in azithromycin-treated MG-NGU when MRM testing is unavailable.


Subject(s)
Mycoplasma Infections , Mycoplasma genitalium , Urethritis , Anti-Bacterial Agents/therapeutic use , Azithromycin/therapeutic use , Chlamydia trachomatis , Drug Resistance, Bacterial , Humans , Macrolides/therapeutic use , Male , Mycoplasma Infections/diagnosis , Mycoplasma Infections/drug therapy , Mycoplasma Infections/microbiology , Mycoplasma genitalium/genetics , Phylogeny , Urethritis/diagnosis , Urethritis/drug therapy , Urethritis/microbiology
3.
Stroke ; 52(1): 253-259, 2021 01.
Article in English | MEDLINE | ID: mdl-33222616

ABSTRACT

BACKGROUND AND PURPOSE: Telestroke has been demonstrated to be a cost-effective means to expand access to care and improve outcomes in stroke; however, information on patient perceptions of this system of care delivery are limited. This study seeks to examine patient feedback of a national telestroke system within the Veterans Health Administration. METHODS: Patients who received a telestroke consultation were eligible for a phone interview 2 weeks later, including questions about technology quality, telepresence, and telestroke provider communication. Satisfaction scores ranged from 1 to 7 (higher=more satisfied) and for analyses were dichotomized as 6 to 7 indicating high satisfaction versus <6. Patient variables including stroke severity (measured by the National Institutes of Health Stroke Scale) were obtained from study records. Generalized estimating equation models were used to determine what factors were associated with patient satisfaction. RESULTS: Over 18 months, 186 interviews were completed, and 142 (76%) reported high satisfaction with telestroke. Patients with more severe stroke were less likely to recall the consultation. Factors significantly associated with patient satisfaction were higher ratings of the technology (P<0.0001), telepresence (P<0.0001), provider communication ratings (P<0.0001), and overall Veterans Affairs satisfaction (P=0.02). In the multivariate model, telepresence (odds ratio, 3.10 [95% CI, 1.81-5.31]) and provider ratings (odds ratio, 2.37 [95% CI, 1.20-4.68]) were independently associated with satisfaction. Veterans who were satisfied were more likely to recommend the technology (P<0.0001). CONCLUSIONS: Provider qualities, including telepresence and provider ratings, were associated with overall Veteran satisfaction with the telestroke consultation. Technology quality may be necessary but not sufficient to impact patient experience. Training providers to improve telepresence could improve patient experience with telestroke consultation.


Subject(s)
Patient Satisfaction , Stroke Rehabilitation/methods , Telemedicine/methods , Aged , Aged, 80 and over , Communication , Female , Humans , Male , Middle Aged , Patient-Centered Care , Referral and Consultation , United States , United States Department of Veterans Affairs , Veterans
4.
Nurs Res ; 70(1): 24-33, 2021.
Article in English | MEDLINE | ID: mdl-32956256

ABSTRACT

BACKGROUND: Dysmenorrhea is a prevalent pain condition among women and a risk factor for other chronic pain conditions. Individuals vary in dysmenorrhea pain severity, the number of painful sites, and co-occurring gastrointestinal symptoms. Three dysmenorrhea symptom-based phenotypes were previously identified using latent class analysis; however, there is a need to validate these in an independent sample, so they can be used in mechanistic and interventional research. There is also a need to further characterize dysmenorrhea symptom-based phenotypes in terms of demographic, clinical, and psychobehavioral characteristics so they can be used to inform precision dysmenorrhea treatment. OBJECTIVES: The study objectives were to (a) determine whether the same dysmenorrhea symptom-based phenotypes would be found in a new sample; (b) determine whether including demographic, clinical, and psychobehavioral covariates in latent class analyses would change individuals' phenotype memberships; and (c) investigate relationships between dysmenorrhea symptom-based phenotypes and demographic, clinical, and psychobehavioral characteristics. METHODS: This cross-sectional survey study included 678 women (aged 14-42 years) with dysmenorrhea. Participants reported dysmenorrhea symptom severity, demographic, clinical (comorbid chronic pain and gynecological conditions), and psychobehavioral characteristics (perceived stress, anxiety, depression, sleep disturbance, and pain catastrophizing). We used latent class analysis to identify symptom-based phenotypes. We compared analyses with and without covariates (i.e., demographic, clinical, and psychobehavioral characteristics) to determine if individuals' phenotype memberships changed. We then examined associations between phenotypes and demographic, clinical, and psychobehavioral characteristics. RESULTS: We reproduced three dysmenorrhea symptom-based phenotypes: the "mild localized pain" phenotype (characterized by mild abdominal cramps), the "severe localized pain" phenotype (characterized by severe abdominal cramps), and the "multiple severe symptoms" phenotype (characterized by severe pain at multiple locations and gastrointestinal symptoms). Analyses with and without covariates had little effect on individuals' phenotype membership. Race, comorbid chronic pain condition, endometriosis, and pain catastrophizing were significantly associated with the dysmenorrhea phenotypes. DISCUSSION: Findings provide a foundation to further study mechanisms of dysmenorrhea symptom heterogeneity and develop dysmenorrhea precision treatments. The three dysmenorrhea symptom-based phenotypes were validated in a second sample. Demographic, clinical, and psychobehavioral factors were associated with dysmenorrhea symptom-based phenotypes.


Subject(s)
Chronic Pain/genetics , Chronic Pain/physiopathology , Dysmenorrhea/genetics , Dysmenorrhea/physiopathology , Phenotype , Severity of Illness Index , Symptom Assessment , Adolescent , Adult , Cross-Sectional Studies , Female , Humans , Surveys and Questionnaires , United States , Young Adult
5.
Br J Sports Med ; 55(24): 1387-1394, 2021 Dec.
Article in English | MEDLINE | ID: mdl-33355211

ABSTRACT

OBJECTIVES: To examine sex differences in sport-related concussion (SRC) across comparable sports. METHODS: Prospective cohort of collegiate athletes enrolled between 2014 and 2017 in the Concussion Assessment, Research and Education Consortium study. RESULTS: Among 1071 concussions (females=615; 57.4%), there was no difference in recovery (median days to full return to play) (females=13.5 (IQR 9.0, 23.1) vs males=11.8 (IQR 8.1, 19.0), p=0.96). In subgroup analyses, female recovery was longer in contact (females=12.7 days (IQR 8.8, 21.4) vs males=11.0 days (IQR 7.9, 16.2), p=0.0021), while male recovery was longer in limited contact sports (males=16.9 days (IQR 9.7, 101.7) vs females=13.8 days (IQR 9.1, 22.0), p<0.0001). There was no overall difference in recovery among Division I schools (females=13.7 (IQR 9.0, 23.1) vs males=12.2 (IQR 8.2 19.7), p=0.5), but females had longer recovery at the Division II/III levels (females=13.0 (IQR 9.2, 22.7) vs males=10.6 (IQR 8.1, 13.9), p=0.0048). CONCLUSION: Overall, no difference in recovery between sexes across comparable women's and men's sports in this collegiate cohort was found. However, females in contact and males in limited contact sports experienced longer recovery times, while females had longer recovery times at the Division II/III level. These disparate outcomes indicate that, while intrinsic biological sex differences in concussion recovery may exist, important, modifiable extrinsic factors may play a role in concussion outcomes.


Subject(s)
Athletic Injuries , Brain Concussion , Athletes , Athletic Injuries/diagnosis , Athletic Injuries/epidemiology , Brain Concussion/diagnosis , Female , Humans , Male , Prospective Studies , Students , Universities
6.
Cancer ; 126(1): 211-218, 2020 01 01.
Article in English | MEDLINE | ID: mdl-31539169

ABSTRACT

BACKGROUND: Fear of cancer recurrence (FCR) has a profound negative impact on quality of life (QOL) for many cancer survivors. Breast cancer survivors (BCS) are particularly vulnerable, with up to 70% reporting clinically significant FCR. To the authors' knowledge, evidence-based interventions for managing FCR are limited. Acceptance and commitment therapy (ACT) promotes psychological flexibility in managing life's stressors. The current study examined the feasibility and preliminary efficacy of group-based ACT for FCR in BCS. METHODS: Post-treatment BCS (91 patients with stage I-III disease) with clinical FCR randomly were assigned to ACT (6 weekly 2-hour group sessions), survivorship education (SE; 6 weekly 2-hour group sessions), or enhanced usual care (EUC; one 30-minute group coaching session with survivorship readings). FCR severity (primary outcome) and avoidant coping, anxiety, post-traumatic stress, depression, QOL, and other FCR-related variables (secondary outcomes) were assessed at baseline (T1), after the intervention (T2), 1 month after the intervention (T3), and 6 months after the intervention (T4) using intent-to-treat analysis. RESULTS: Satisfactory recruitment (43.8%) and retention (94.5%) rates demonstrated feasibility. Although each arm demonstrated within-group reductions in FCR severity over time, only ACT produced significant reductions at each time point compared with baseline, with between-group differences at T4 substantially favoring ACT over SE (Cohen d for effect sizes, 0.80; P < .001) and EUC (Cohen d, 0.61; P < .01). For 10 of 12 secondary outcomes, only ACT produced significant within-group reductions across all time points. By T4, significant moderate to large between-group comparisons favored ACT over SE and EUC with regard to avoidant coping, anxiety, depression, QOL, and FCR-related psychological distress. CONCLUSIONS: Group-based ACT is a feasible and promising treatment for FCR and associated outcomes in BCS that warrants testing in larger, fully powered trials.


Subject(s)
Breast Neoplasms/psychology , Cancer Survivors , Fear/psychology , Neoplasm Recurrence, Local/psychology , Adult , Aged , Anxiety/drug therapy , Anxiety/epidemiology , Anxiety/pathology , Breast/pathology , Breast Neoplasms/drug therapy , Breast Neoplasms/epidemiology , Breast Neoplasms/pathology , Depression/drug therapy , Depression/epidemiology , Depression/pathology , Female , Humans , Involuntary Commitment , Middle Aged , Neoplasm Recurrence, Local/drug therapy , Neoplasm Recurrence, Local/pathology , Neoplasm Recurrence, Local/prevention & control , Neoplasm Staging , Phobic Disorders/drug therapy , Phobic Disorders/epidemiology , Phobic Disorders/pathology , Quality of Life , Stress Disorders, Post-Traumatic/complications , Stress Disorders, Post-Traumatic/epidemiology , Stress Disorders, Post-Traumatic/pathology , Stress Disorders, Post-Traumatic/psychology
7.
Sex Transm Infect ; 96(4): 306-311, 2020 06.
Article in English | MEDLINE | ID: mdl-31515293

ABSTRACT

OBJECTIVES: Chlamydia trachomatis (CT) and Mycoplasma genitalium (MG) cause the majority of non-gonococcal urethritis (NGU). The role of Ureaplasma urealyticum (UU) in NGU is unclear. Prior case-control studies that examined the association of UU and NGU may have been confounded by mixed infections and less stringent criteria for controls. The objective of this case-control study was to determine the prevalence and aetiology of mixed infections in men and assess if UU monoinfection is associated with NGU. METHODS: We identified 155 men with NGU and 103 controls. Behavioural and clinical information was obtained and men were tested for Neisseria gonorrhoeae and CT, MG, UU and Trichomonas vaginalis (TV). Men who were five-pathogen negative were classified as idiopathic urethritis (IU). RESULTS: Twelve per cent of NGU cases in which a pathogen was identified had mixed infections, mostly UU coinfections with MG or CT; 27% had IU. In monoinfected NGU cases, 34% had CT, 17% had MG, 11% had UU and 2% had TV. In controls, pathogens were rarely identified, except for UU, which was present in 20%. Comparing cases and controls, NGU was associated with CT and MG monoinfections and mixed infections. UU monoinfection was not associated with NGU and was almost twice as prevalent in controls. Men in both the case and control groups who were younger and who reported no prior NGU diagnosis were more likely to have UU (OR 0.97 per year of age, 95% CI 0.94 to 0.998 and OR 6.3, 95% CI 1.4 to 28.5, respectively). CONCLUSIONS: Mixed infections are common in men with NGU and most of these are UU coinfections with other pathogens that are well-established causes of NGU. UU monoinfections are not associated with NGU and are common in younger men and men who have never previously had NGU. Almost half of NGU cases are idiopathic.


Subject(s)
Chlamydia trachomatis/isolation & purification , Coinfection/epidemiology , Mycoplasma genitalium/isolation & purification , Trichomonas vaginalis/isolation & purification , Ureaplasma urealyticum/isolation & purification , Urethritis/epidemiology , Adolescent , Adult , Case-Control Studies , Coinfection/etiology , Humans , Male , Middle Aged , Neisseria gonorrhoeae/isolation & purification , Prevalence , Urethritis/etiology , Young Adult
8.
Sex Transm Dis ; 47(5): 329-331, 2020 05.
Article in English | MEDLINE | ID: mdl-32149960

ABSTRACT

Identifying pathogen-specific signs or symptoms of nongonococcal urethritis could improve syndromic management accuracy. We evaluated nongonococcal urethritis signs and symptoms in 220 men with single-pathogen infections (Chlamydia trachomatis, Mycoplasma genitalium, Trichomonas vaginalis, or Ureaplasma urealyticum) or idiopathic urethritis. No individual sign or symptom accurately predicted the infectious etiology.


Subject(s)
Mycoplasma genitalium , Urethra/microbiology , Urethritis/diagnosis , Adolescent , Adult , Humans , Indiana , Male , Middle Aged , Mycoplasma Infections/diagnosis , Mycoplasma genitalium/isolation & purification , Ureaplasma urealyticum/isolation & purification , Urethritis/microbiology , Young Adult
9.
Sex Transm Dis ; 46(7): 440-445, 2019 07.
Article in English | MEDLINE | ID: mdl-31194715

ABSTRACT

BACKGROUND: Rectal infection with Chlamydia trachomatis (CT) is frequent in women who deny receptive anal sex and is thought to arise from autoinoculation of the rectum from vaginal secretions. An alternate hypothesis is that oral sex inoculates and establishes gastrointestinal tract infection. Distinguishing these hypotheses is difficult in women. In men, autoinoculation is unlikely and heterosexual men frequently perform oral sex, but rarely participate in receptive anal exposure behaviors. METHODS: We enrolled high-risk men with and without nongonococcal urethritis who presented to a sexually transmitted infection clinic in Indianapolis, Indiana. Urine and rectal swabs were collected and tested for urogenital and rectal CT, Neisseria gonorrhoeae (NG), and Mycoplasma genitalium (MG). Men completed surveys concerning symptoms, sexual orientation, and detailed recent and lifetime oral and anal sexual behaviors. RESULTS: Rectal CT was detected in 2/84 (2.4%) heterosexual men who reported cunnilingus, but no lifetime receptive anal behaviors. All of the men who denied receptive anal behaviors were negative for rectal NG and MG. In homosexual and bisexual men, rectal CT prevalence was high (9.7%), and rectal NG (4.8%) and MG (4.8%) were also detected. CONCLUSIONS: We detected rectal CT infections in heterosexual men who reported cunnilingus but denied receptive anal behaviors. Oral sex may be a risk factor for rectal CT infection via oral inoculation of the gastrointestinal tract.


Subject(s)
Chlamydia Infections/diagnosis , Chlamydia trachomatis/isolation & purification , Sexual Behavior/statistics & numerical data , Sexually Transmitted Diseases/diagnosis , Sexually Transmitted Diseases/epidemiology , Adolescent , Adult , Aged , Anal Canal/microbiology , Chlamydia Infections/epidemiology , Chlamydia Infections/microbiology , Heterosexuality , Humans , Indiana/epidemiology , Male , Middle Aged , Prevalence , Rectum/microbiology , Risk Factors , Sexually Transmitted Diseases/microbiology , Surveys and Questionnaires , Young Adult
11.
J Dent ; 141: 104831, 2024 02.
Article in English | MEDLINE | ID: mdl-38190879

ABSTRACT

OBJECTIVE: Quantify the survival of posterior composite restorations (PCR) placed during the study period in permanent teeth in United States (US) general dental community practices and factors predictive of that survival. METHODS: A retrospective cohort study was conducted utilizing de-identified electronic dental record (EDR) data of patients who received a PCR in 99 general dentistry practices in the National Dental Practice-Based Research Network (Network). The final analyzed data set included 700,885 PCRs from 200,988 patients. Descriptive statistics and Kaplan Meier (product limit) estimator were performed to estimate the survival rate (defined as the PCR not receiving any subsequent treatment) after the first PCR was observed in the EDR during the study time. The Cox proportional hazards model was done to account for patient- and tooth-specific covariates. RESULTS: The overall median survival time was 13.3 years. The annual failure rates were 4.5-5.8 % for years 1-5; 5.3-5.7 %, 4.9-5.5 %, and 3.3-5.2 % for years 6-10, 11-15, and 16-20, respectively. The failure descriptions recorded for < 7 % failures were mostly caries (54 %) and broken or fractured tooth/restorations (23 %). The following variables significantly predicted PCR survival: number of surfaces that comprised the PCR; having at least one interproximal surface; tooth type; type of prior treatment received on the tooth; Network region; patient age and sex. Based on the magnitude of the multivariable estimates, no single factor predominated. CONCLUSIONS: This study of Network practices geographically distributed across the US observed PCR survival rates and predictive factors comparable to studies done in academic settings and outside the US. CLINICAL SIGNIFICANCE: Specific baseline factors significantly predict the survival of PCRs done in US community dental practices.


Subject(s)
Dental Caries , Dental Restoration, Permanent , Humans , Composite Resins , Retrospective Studies , Dental Restoration Failure , Survival Analysis , Dental Caries/therapy
12.
Neurology ; 100(14): e1510-e1519, 2023 04 04.
Article in English | MEDLINE | ID: mdl-36653178

ABSTRACT

BACKGROUND AND OBJECTIVES: Some athletes experience a slow recovery after sport-related concussion (SRC). There is little agreement on what constitutes slow recovery, however, and minimal data on the prevalence, predictors, or prognosis for this group. The objectives of this study were to apply an operationalized definition of slow recovery and characterize predictors and long-term prognosis of these individuals. METHODS: This is a prospective multisite observational study of collegiate athletes. Participants underwent multimodal assessments preseason and 5 additional time points after SRC. Time from injury to initiation of return to play progression (asymptomatic timepoint) and from injury to return to play (RTP) were the primary markers of recovery. RESULTS: One thousand seven hundred fifty-one concussed male and female collegiate athletes were studied. Eighty percent of participants reached the asymptomatic and/or RTP time points by days 14 and 24, respectively. Slow recovery was thus defined as exceeding 1 or both of those intervals (n = 399). This group was statistically more likely to be female (41.1% vs 35.6%, p = 0.05), have higher initial postinjury SCAT symptom severity scores (mean [SD]: 36.6 [23.4] vs 25.4 [19.9], p < 0.001), lower postinjury Standardized Assessment of Concussion scores (mean [SD]:25.74 [2.98] vs 26.26 [2.85], p = 0.004), perform worse on the postinjury Balance Error Scoring System (mean [SD]: 17.8 [8.9] vs 15.9 [8.5], p < 0.01), have fewer assessments in the first 14 days after injury (mean [SD]: 48.8 [29.7] vs 67.9 [24.6], p < 0.01), and be injured in practice (70.7% vs 65.1%, p = 0.04). 77.6% of the slow recovery group returned to play within 60 days of injury, and 83.4% (n = 349) returned to play within 90 days of injury. Only 10.6% had not returned to play 6 months postinjury. DISCUSSION: This study suggests an overall favorable prognosis for slowly recovering athletes and provides data for athletes and medical teams to consider in calibrating RTP expectations and making decisions about medical disqualification vs ongoing engagement in their sport.


Subject(s)
Athletic Injuries , Brain Concussion , Humans , Male , Female , Athletic Injuries/diagnosis , Prospective Studies , Neuropsychological Tests , Brain Concussion/diagnosis , Brain Concussion/epidemiology , Brain Concussion/therapy , Athletes
13.
Sports Med ; 52(2): 403-415, 2022 Feb.
Article in English | MEDLINE | ID: mdl-34427877

ABSTRACT

BACKGROUND: Sport-related concussion is recognized as a significant injury with variable recovery rates. OBJECTIVE: This study defined the acute natural history of sport concussion in male and female collegiate athletes participating in a broad array of sports. METHODS: We conducted a prospective, longitudinal investigation among collegiate student athletes (n = 34,709) from 30 academic institutions. Primary outcomes included the time (days) from injury until initiation of a return to participation (RTP) protocol and time from injury until medical clearance for unrestricted RTP. RESULTS: Concussed athletes (n = 1751, 19.2 years, 63.2% male) participating in 22 different sports began the RTP protocol in a median 6.4 (IQR 3.7-11.8) days. Time to initiate the RTP protocol was lengthened by less frequent post-injury assessments, greater initial post-injury symptom severity, limited contact sports participation, practice/training injuries, and three or more prior concussions. The median total RTP duration was 12.8 (IQR 8.7-20.1) days. Total RTP duration was shorter with ADHD medication usage, males, and greater assessment frequency; while greater initial post-injury symptom severity, practice-/training-related injuries, and three or more prior concussions had longer recoveries. CONCLUSION: Although median recovery times are consistent with previous guidelines, it was not until 1 month post-injury that a preponderance of collegiate athletes were cleared to begin the RTP protocol (92%) or cleared for unrestricted sport participation (85%). Intrinsic and extrinsic factors had a small effect, altering recovery trajectories by up to 2 days, suggesting a largely unified approach to post-injury monitoring and management across all athletes. These data represent a shift from previous classification parameters of normal clinical recovery.


Subject(s)
Athletic Injuries , Brain Concussion , Sports , Athletes , Athletic Injuries/diagnosis , Brain Concussion/diagnosis , Female , Humans , Male , Prospective Studies
14.
Open Respir Arch ; 4(3): 100189, 2022.
Article in English | MEDLINE | ID: mdl-37496578

ABSTRACT

Introduction: The COVID-19 pandemic highlighted that surges in critical care demand can overwhelm existing healthcare infrastructures, most evident in the acute shortage of mechanical ventilators across the globe. Despite efforts to encourage urgent authorization of newly developed emergency ventilators, the currently available testing protocols are not internationally accepted, standardized and none address testing in clinical settings. The aim of this study was to compile and perform a comprehensive clinical testing protocol for a newly developed emergency ventilator. Methods: Using previously available guidance, we compiled a sequential testing protocol with a: 1. preclinical, 2. safety testing, 3. clinician usability test and 4. clinical stage involving respiratory failure patients. The protocol was then tested on the Luca ventilator, a mechanical ventilator capable of sophisticated ventilator settings rapidly developed specifically in response to the COVID-19 pandemic. Results: During the pre-clinical/safety stages, the ventilator produced pressure and volume changes deemed acceptable by the Rapidly Manufactured Ventilator System guideline. Furthermore, our protocol allowed the identification of a number of issues that were easily resolved with minor software adjustments. Usability was excellent (overall System Usability Scale score = 90.5). Clinical testing revealed that a sampling frame of 15 critically ill patients was sufficiently powered to detect any significant, clinically relevant differences between the Luca ventilator and a standard ICU ventilator. Conclusions: The ventilator was accurate, reliable, safe, and user-friendly. The implementation of a comprehensive, standardized pre-clinical/clinical testing protocol is feasible, potentially enabling the safe and timely emergency authorization of rapidly developed mechanical ventilators crucial in pandemic situations.


Introducción: La pandemia de COVID-19 ha puesto de manifiesto que las sobrecargas en los cuidados intensivos pueden desbordar las infraestructuras sanitarias existentes, que fue evidente en la escasez inmediata de respiradores mecánicos observada en todo el mundo. A pesar de las tentativas de alentar la autorización urgente de respiradores de emergencia recién desarrollados, los protocolos de ensayos existentes no están aceptados en todo el mundo, no están normalizados y ninguno trata los ensayos en entornos clínicos. El objetivo de este estudio fue recopilar y ejecutar un protocolo de ensayos clínicos exhaustivo para un respirador de emergencia recién desarrollado. Métodos: Aplicando las directrices previas recopilamos un protocolo secuencial de ensayos con: 1. estudio preclínico, 2. estudio de seguridad, 3. ensayo de operabilidad por los facultativos y 4. fase clínica con participación de pacientes con insuficiencia respiratoria. Se analizó el protocolo con el respirador Luca, un respirador mecánico con configuraciones sofisticadas desarrollado rápida y específicamente para responder a la pandemia de la COVID-19. Resultados: Durante las fases preclínicas/de seguridad, los cambios de presión y volumen que produjo el respirador se consideraron aceptables, según la directriz Rapidly Manufactured Ventilator System. Asimismo, nuestro protocolo permitió identificar varios problemas que se resolvieron fácilmente con mínimos ajustes de software. La operabilidad resultó excelente (puntuación total de la escala de operabilidad del sistema = 90,5). Los ensayos clínicos revelaron que una muestra de 15 pacientes graves presentaba suficiente potencia estadística para detectar todas las diferencias significativas de interés clínico entre el respirador Luca y uno de Unidad de Cuidados Intensivos ordinario. Conclusiones: El respirador resultó exacto, fiable, seguro y fácil de usar. La implantación de un protocolo de ensayos preclínicos y clínicos exhaustivo y normalizado es factible y puede habilitar la autorización de emergencia oportuna de respiradores mecánicos de desarrollo rápido, cruciales en situaciones pandémicas.

15.
Neurology ; 98(16): e1617-e1625, 2022 04 19.
Article in English | MEDLINE | ID: mdl-35228338

ABSTRACT

BACKGROUND AND OBJECTIVES: Telestroke networks are associated with improved outcomes from acute ischemic stroke (AIS) and facilitate greater access to care, particularly in underserved regions. These networks also have the potential to influence patient disposition through avoiding unnecessary interhospital transfers. This study examines the effect of implementation of the VA National Telestroke Program (NTSP) on interhospital transfer among Veterans. METHODS: We analyzed patients with AIS presenting to the emergency departments of 21 VA hospitals before and after telestroke implementation. Transfer rates were determined through review of administrative data and chart review and patient and facility-level characteristics were collected to identify predictors of transfer. Comparisons were made using t test, Wilcoxon rank sum, and χ 2 analysis. Multivariable logistic regression with sensitivity analysis was conducted to assess the influence of telestroke implementation on transfer rates. RESULTS: We analyzed 3,488 stroke encounters (1,056 pre-NTSP and 2,432 post-NTSP). Following implementation, we observed an absolute 14.4% decrease in transfers across all levels of stroke center designation. Younger age, higher stroke severity, and shorter duration from symptom onset were associated with transfer. At the facility level, hospitals with lower annual stroke volume were more likely to transfer; 1 hospital saw an increase in transfer rates following implementation. After adjusting for patient and facility characteristics, the implementation of VA NTSP resulted in a nearly 60% reduction in odds of transfer (odds ratio 0.39 [0.19, 0.77]). DISCUSSION: In addition to improving treatment in acute stroke, telestroke networks have the potential to positively affect the efficiency of interhospital networks through disposition optimization and the avoidance of unnecessary transfers.


Subject(s)
Ischemic Stroke , Stroke , Telemedicine , Emergency Service, Hospital , Hospitals , Humans , Stroke/drug therapy , Stroke/therapy , Thrombolytic Therapy , Time Factors
16.
J Aging Health ; 34(1): 130-143, 2022 01.
Article in English | MEDLINE | ID: mdl-34346261

ABSTRACT

OBJECTIVES: This study aimed to replicate music's positive effects on dementia-related symptoms, determine whether a 6-month intervention would lead to greater positive outcomes than typical 3- to 4-month interventions, and examine changes in sundowning symptoms after music listening. METHODS: 282 nursing home residents with dementia listened to personalized music playlists 1-3 times weekly for 30 minutes across 6 months. Standardized assessments of affect, behavior, and cognition and direct observations of sundowning symptoms comprised the outcomes. RESULTS: Results documented significant improvements in residents' general neuropsychiatric symptoms, agitation, and depression across the first 3 months, but no additional improvements across the subsequent 3 months. Seven sundowning symptoms significantly improved following music listening, with some (e.g., disengagement) being more amenable to music than others (e.g., aggression). DISCUSSION: Results support short-term individualized music listening as an effective non-pharmacological approach for improving dementia-related symptoms in nursing home residents and suggest new applications of music-related interventions.


Subject(s)
Dementia , Music Therapy , Music , Cognition , Dementia/psychology , Dementia/therapy , Humans , Long-Term Care , Music Therapy/methods , Nursing Homes
17.
J Aging Health ; 34(6-8): 1037-1047, 2022 10.
Article in English | MEDLINE | ID: mdl-35465759

ABSTRACT

Objective: The goal of this exploratory study was to predict which long-term care residents with dementia would experience improvements in their sundowning symptoms after listening to personalized music playlists. Methods: We studied 101 residents with moderate to severe dementia from 15 long-term care facilities across 8 months. We observed residents' behavioral responses to individualized music while they listened and recorded sundowning symptoms both before and after each listening session. Results: As hypothesized, residents who exhibited a greater number of positive reactive behaviors while listening to music also evidenced more improvements in their confusion, disengagement, unresponsiveness, and restlessness after their music-listening session. Discussion: Our results reveal that observing behavioral responses during music listening is an effective way to determine when nursing home residents are benefiting from personalized music playlists. These findings inform music programs in long-term care settings by identifying residents whose sundowning symptoms are most amenable to music intervention.


Subject(s)
Dementia , Music Therapy , Music , Dementia/therapy , Humans , Long-Term Care , Music Therapy/methods , Nursing Homes
18.
J Womens Health (Larchmt) ; 30(9): 1334-1343, 2021 09.
Article in English | MEDLINE | ID: mdl-33026968

ABSTRACT

Background: Dysmenorrhea affects most reproductive-aged women. Common dysmenorrhea treatments vary in their effectiveness across individuals. Little is known about factors associated with perceived treatment ineffectiveness. The objectives of this study were to describe the perceived ineffectiveness of common pharmacological treatments for dysmenorrhea and investigate factors associated with perceived treatment ineffectiveness. Materials and Methods: In this cross-sectional study, 678 women with dysmenorrhea (aged 14-42) provided data on perceived treatment ineffectiveness, dysmenorrhea symptom-based phenotypes, demographics, clinical factors, and psychobehavioral characteristics. We used Fisher's exact tests to compare treatment ineffectiveness across three symptom-based phenotypes. We used logistic regressions to explore associations of phenotype, demographic, clinical, and psychobehavioral correlates of perceived treatment ineffectiveness. Results: Percentages perceiving treatments as ineffective were 29.3%-35.6% nonsteroidal anti-inflammatory drugs, 49.9% acetaminophen, and 39.3% combined oral contraceptive pills (OCPs). Factors associated with perceived ineffectiveness varied across treatments and included symptom-based phenotypes, clinical, and psychobehavioral factors. For ibuprofen and acetaminophen, women with severe (vs. mild) pain phenotype and higher number of chronic pain conditions were more likely to perceive the treatments as ineffective. For OCPs, women with severe pain (vs. mild) phenotype, comorbid gynecological condition, less anxiety, and worse depressive symptoms were more likely to perceive the treatment as ineffective. Conclusion: A significant percentage of women reported ineffectiveness of dysmenorrhea treatments. Phenotypes, clinical, and psychobehavioral factors were associated with treatment ineffectiveness. Future research should test if symptom-based phenotypes are associated with treatment effectiveness in clinical trials and investigate other factors that affect dysmenorrhea treatment effectiveness, so treatments can be tailored to individuals.


Subject(s)
Dysmenorrhea , Adult , Cross-Sectional Studies , Dysmenorrhea/drug therapy , Dysmenorrhea/epidemiology , Female , Humans
19.
West J Nurs Res ; 43(4): 364-373, 2021 04.
Article in English | MEDLINE | ID: mdl-32680445

ABSTRACT

Dysmenorrhea affects most reproductive-age women and increases the risk of future pain. To evaluate dysmenorrhea interventions, validated outcome measures are needed. In this two-phase study, we developed and tested the dysmenorrhea symptom interference scale. During the scale-development phase (n = 30), we created a nine-item scale based on qualitative data from cognitive interviews. During the scale-testing phase (n = 686), we evaluated reliability, validity, and responsiveness to change. The scale measures how dysmenorrhea symptoms interfere with physical, mental, and social activities. Internal consistency was strong with Cronbach's α > 0.9. Test-retest reliability was acceptable (r = 0.8). The scale showed satisfactory content validity, construct validity (supported by confirmatory factor analysis), concurrent validity, and responsiveness to change. The minimally important difference was 0.3 points on a scale with a possible total score ranging from 1 to 5. This new psychometrically sound scale can be used in research and clinical practice to facilitate the measurement and management of dysmenorrhea.


Subject(s)
Dysmenorrhea , Dysmenorrhea/diagnosis , Factor Analysis, Statistical , Female , Humans , Psychometrics , Reproducibility of Results , Surveys and Questionnaires
20.
Clin Kidney J ; 14(7): 1738-1746, 2021 Jul.
Article in English | MEDLINE | ID: mdl-34221381

ABSTRACT

BACKGROUND: Autosomal dominant polycystic kidney disease (ADPKD) is one of the most common monogenetic disorders in humans and is characterized by numerous fluid-filled cysts that grow slowly, resulting in end-stage renal disease in the majority of patients. Preclinical studies have indicated that treatment with low-dose thiazolidinediones, such as pioglitazone, decrease cyst growth in rodent models of PKD. METHODS: This Phase 1b cross-over study compared the safety of treatment with a low dose (15 mg) of the peroxisome proliferator-activated receptor-γ (PPAR-γ) agonist pioglitazone or placebo in PKD patients, with each treatment given for 1 year. The study monitored known side effects of PPAR-γ agonist treatment, including fluid retention and edema. Liver enzymes and risk of hypoglycemia were assessed throughout the study. As a secondary objective, the efficacy of low-dose pioglitazone was followed using a primary assessment of total kidney volume (TKV), blood pressure (BP) and kidney function. RESULTS: Eighteen patients were randomized and 15 completed both arms. Compared with placebo, allocation to pioglitazone resulted in a significant decrease in total body water as assessed by bioimpedance analysis {mean difference 0.16 Ω [95% confidence interval (CI) 0.24-2.96], P = 0.024} and no differences in episodes of heart failure, clinical edema or change in echocardiography. Allocation to pioglitazone led to no difference in the percent change in TKV of -3.5% (95% CI -8.4-1.4, P = 0.14), diastolic BP and microalbumin:creatinine ratio. CONCLUSIONS: In this small pilot trial in people with ADPKD but without diabetes, pioglitazone 15 mg was found to be as safe as placebo. Larger and longer-term randomized trials powered to assess effects on TKV are needed.

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