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2.
Health Qual Life Outcomes ; 22(1): 19, 2024 Feb 20.
Article in English | MEDLINE | ID: mdl-38378572

ABSTRACT

BACKGROUND: Despite a number of respiratory syncytial virus (RSV) vaccine candidates being tested in clinical trials, disease-specific, self-reported instruments assessing symptom severity of RSV infection from the perspective of adult patients are still needed. The RSV Infection, Intensity and Impact Questionnaire (RSV-iiiQ) was adapted from the Influenza Intensity and Impact Questionnaire (FluiiQ™). This study evaluated some measurement properties of the RSV-iiiQ. METHODS: Data were collected in a web-based survey over two consecutive days. Participants completed the RSV-iiiQ, the Patient Global Impression of Severity, Sheehan Disability Scale, Patient Global Impression of Change, EQ-5D-5L, and a demographic questionnaire. Test-retest reliability, internal consistency, construct validity, and responsiveness of the RSV-iiiQ scales were assessed. RESULTS: 111 adults with RSV were enrolled and self-reported a variety of symptoms across the range of disease severity via a web-based platform. The RSV-iiiQ scales demonstrated satisfactory test-retest reliability, construct validity, and discriminating ability. One-factor confirmatory factor analyses confirmed that each of the four scales was sufficiently unidimensional, and internal consistencies indicated that the computation of RSV-iiiQ scale scores was plausible. Correlation-based analyses provided support for the construct validity of the RSV-iiiQ scores, and known groups analyses supported discriminating ability. Estimates of responsiveness of the scale scores were also satisfactory. CONCLUSIONS: RSV infection is highly symptomatic and causes significant disease burden, and self-report instruments assessing symptom severity and impact are important for evaluation of new treatments. This study describes the preliminary psychometric properties of the RSV-iiiQ and indicates this tool may be useful for the assessment of the severity of symptoms and impact of acute RSV infection in adults. The findings also indicated two items, Runny nose and Ear pain, may be unnecessary and should be revisited using item response theory analysis with a larger sample size.


Subject(s)
Respiratory Syncytial Virus Infections , Adult , Humans , Respiratory Syncytial Virus Infections/diagnosis , Psychometrics , Reproducibility of Results , Quality of Life , Surveys and Questionnaires
3.
J Patient Rep Outcomes ; 7(1): 105, 2023 Oct 30.
Article in English | MEDLINE | ID: mdl-37902847

ABSTRACT

BACKGROUND: Patient-reported outcome measures that facilitate self-report by children are needed to reduce the bias of proxy report. We previously developed an electronic Pediatric Asthma Symptom Diary (ePASD) to assess the severity of daily asthma symptoms and proximal impacts in children aged 6-11 years with mild to severe asthma. The ePASD, administered via a digital application with visuals, sounds, and text, is uniquely designed to minimize the importance of reading skills on children's ability to self-report accurately. Here, we describe the ePASD's psychometric properties. METHODS: Ninety-one children aged 6-11 years with mild to severe asthma and their caregivers participated in 2 study visits, which consisted of training on the provisioned device and completing asthma-specific clinical outcome assessment (COA) questionnaires. The children self-completed the ePASD at home twice daily for 8 consecutive days. The scoring of the ePASD was guided by factor analyses, inter-item correlations, and internal consistencies. Reliability, discriminating ability, construct validity, and responsiveness were evaluated for ePASD items and candidate scores. RESULTS: All COAs included in the study-the ePASD, Asthma Control Questionnaire (ACQ), Childhood Asthma Control Test, Pediatric Asthma Quality of Life Questionnaire-Standardized (PAQLQ[S]), and global ratings-demonstrated that the children exhibited few asthma-related symptoms and impacts at all timepoints, and consequently, showed little change over time. Internal consistencies (all Cronbach's alphas ≥ 0.52) and test-retest reliabilities (all intraclass correlation coefficients ≥ 0.60) were largely satisfactory. Patterns of convergent and divergent correlations supported the construct validity of ePASD scores. The ePASD symptom scores correlated moderately to strongly with PAQLQ(S) Symptom scores (all correlations ≥ - 0.46) and with ACQ scores (all correlations ≥ 0.42), as predicted. Evidence of the discriminating ability of ePASD items and composite scores was demonstrated by known-groups analyses. CONCLUSIONS: The ePASD is a reliable and valid measure of asthma symptoms and proximal impacts in children aged 6-11 years with mild, moderate, or severe asthma. These results lay the psychometric groundwork for use of the ePASD in future clinical trials for the management of pediatric asthma. An ongoing pediatric asthma treatment trial is anticipated to provide evidence of the ePASD's responsiveness to change.


Subject(s)
Asthma , Quality of Life , Humans , Child , Child, Preschool , Psychometrics , Reproducibility of Results , Asthma/diagnosis , Surveys and Questionnaires
4.
J Med Screen ; : 9691413231208160, 2023 Oct 19.
Article in English | MEDLINE | ID: mdl-37855047

ABSTRACT

BACKGROUND: The lung cancer screening program at St Elizabeth Healthcare (Kentucky, USA) began in 2013. Over 33,000 low-dose computed tomography lung cancer screens have been performed. From 2015 through 2021, 2595 lung cancers were diagnosed systemwide. A Screening Program with Impactful Results from Early Detection, reviews that experience; 342 (13.2%) were diagnosed by screening and 2253 (86.8%) were non-screened. As a secondary objective, the non-screened cohort was queried to determine how many additional individuals could have been screened, identifying barriers and failures to meet eligibility. METHODS: Our QlikSense database extracted the lung cancer patients from the Cancer Patient Data and Management System, and identified and categorized them separately as screened or non-screened populations. Stage distribution was compared in screened and non-screened groups. Those meeting age criteria, with any smoking history, were further queried for screening eligibility, accessing the electronic medical record smoking history and audit trail, and determining if enough information was available to substantiate screening eligibility. The same methodology was applied to CMS 2015 and USPSTF 2021 criteria. RESULTS: The screened and non-screened patients were accounted for in a stage migration chart demonstrating clear shift to early stage among screened lung cancer patients. Additionally, analysis of non-screened individuals is presented. CONCLUSION: Of the St Elizabeth Healthcare eligible patients attributed to primary care providers, 49.6% were screened in 2021. Despite this level of success, this study highlighted a sizeable pool of additional individuals that could have been screened. We are shifting focus to the non-screened pool of patients that meet eligibility, further enhancing the impact on our community.

5.
Bioethics ; 37(9): 879-885, 2023 11.
Article in English | MEDLINE | ID: mdl-37732566

ABSTRACT

In-vitro fertilization clinics across the world currently use the body mass index (BMI) to assess risk for and determine access to in-vitro fertilization (IVF); however, clinics vary widely in both setting specific BMI limits for access to IVF and articulating the reasons for their policies. Given that scholars have begun to question the usefulness of BMI for individual health risk assessment, it is striking that ethicists have not yet systematically evaluated the reasons given for using BMI in assessing individuals' risk in IVF treatments. In this paper, I provide the first systematic analysis of the chief arguments currently offered by IVF programs for using BMI as a criterion for risk assessment. Specifically, I articulate empirical concerns about the success of IVF in high-BMI patients, practical concerns about the ability of high-BMI patients to safely undergo procedures associated with IVF, and ethical concerns about the risk-to-reward ratio for high-BMI patients and their potential children. I advance a series of objections to those arguments, using empirical data regarding IVF procedures and analogies with other high-risk conditions including systemic lupus erythematosus, and science regarding the diagnosis of BMI-correlated comorbidities such as high blood pressure or diabetes to argue that BMI alone is not a reasonable criterion for risk assessment in IVF; moreover, the usage of BMI may involve unacceptable violations of the bioethical principles of justice and respect for autonomy. Instead, I hold that IVF programs should rely on more precise laboratory and clinical measurements to evaluate risk in IVF.


Subject(s)
Fertilization in Vitro , Fertilization , Child , Humans , Body Mass Index , Risk Assessment , Retrospective Studies
6.
J Patient Rep Outcomes ; 7(1): 45, 2023 05 17.
Article in English | MEDLINE | ID: mdl-37195456

ABSTRACT

BACKGROUND: The Symptoms of Infection with Coronavirus-19 (SIC) is a 30-item patient-reported outcome (PRO) measure scored by body system composites to assess signs/symptoms of coronavirus disease 2019 (COVID-19). In addition to cross-sectional and longitudinal psychometric evaluations, qualitative exit interviews were conducted to support the content validity of the SIC. METHODS: In a cross-sectional study, adults diagnosed with COVID-19 in the United States completed the web-based SIC and additional PRO measures. A subset was invited to participate in phone-based exit interviews. Longitudinal psychometric properties were assessed in ENSEMBLE2, a multinational, randomized, double-blind, placebo-controlled, phase 3 trial of the Ad26.COV2.S COVID-19 vaccine. Psychometric properties evaluated included structure, scoring, reliability, construct validity, discriminating ability, responsiveness, and meaningful change thresholds of SIC items and composite scores. RESULTS: In the cross-sectional study, 152 participants completed the SIC (mean age, 51.0 ± 18.6 years) and 20 completed follow-up interviews. Fatigue (77.6%), feeling unwell (65.8%), and cough (60.5%) were symptoms most frequently reported. SIC inter-item correlations were all positive and mostly moderate (r ≥ 0.3) and statistically significant. SIC items and Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) scores correlated as hypothesized (all r ≥ 0.32). Internal consistency reliabilities of all SIC composite scores were satisfactory (Cronbach's alpha, 0.69-0.91). SIC composite scores correlated moderately (r = 0.30-0.49) to strongly (r ≥ 0.50) with PROMIS-29 scores and Patient Global Impression of Severity (PGIS) ratings (all P < 0.01). A variety of signs/symptoms were cited in exit interviews, and participants considered the SIC straightforward, comprehensive, and easy to use. From ENSEMBLE2, 183 participants with laboratory-confirmed moderate to severe/critical COVID-19 were included (51.5 ± 14.8 years). Strong test-retest reliabilities were observed for most SIC composite scores (intraclass correlations ≥ 0.60). Statistically significant differences across PGIS severity levels were found for all but 1 composite score, supporting known-groups validity. All SIC composite scores demonstrated responsiveness based on changes in PGIS. CONCLUSIONS: The psychometric evaluations provided strong evidence for the reliability and validity of the SIC for measuring COVID-19 symptoms, supporting its use in vaccine and treatment trials. In exit interviews, participants described a broad range of signs/symptoms consistent with previous research, further supporting the content validity and format of the SIC.


Coronavirus disease 2019 (COVID-19) is a serious disease that continues to evolve globally. Researchers developed the Symptoms of Infection with Coronavirus-19 (SIC), a 30-item questionnaire designed for patients to report signs and symptoms of COVID-19. In this study, the researchers formally analyzed how well the SIC measures the patient experience with COVID-19, using survey and clinical trial data as well as telephone interviews. Adults with COVID-19 and at least 2 bothersome symptoms completed the web-based survey, and some of these individuals also participated in in-depth interviews. Participants in a clinical trial for a COVID-19 vaccine also completed the SIC measure. The SIC was compared with other commonly used questionnaires that evaluate patient experience. The most commonly reported symptoms of COVID-19 were fatigue, feeling unwell, cough, weakness, and headache. The items for individual symptoms (e.g., "cough") and combined scores for body systems (e.g., "respiratory system") performed well in statistical analyses. Participants found the SIC to be straightforward, comprehensive, and easy to use. The SIC may prove useful in the future for vaccine and treatment trials for COVID-19.


Subject(s)
Ad26COVS1 , COVID-19 , Adult , Humans , Middle Aged , Aged , Cross-Sectional Studies , Psychometrics/methods , Reproducibility of Results , COVID-19 Vaccines , Surveys and Questionnaires
7.
Health Qual Life Outcomes ; 21(1): 20, 2023 Feb 28.
Article in English | MEDLINE | ID: mdl-36855175

ABSTRACT

BACKGROUND: Respiratory syncytial virus (RSV) causes significant morbidity and mortality in older adults. Despite a number of RSV vaccine candidates in clinical trials, there are no existing disease-specific, self-reported measures that assess the symptoms and severity of RSV infection from the perspective of adult patients with acute RSV. The objective of this study was to describe the initial conceptualization and development of the RSV Infection, Intensity and Impact Questionnaire (RSV-iiiQ), a new patient-reported outcome measure. METHODS: A targeted review of the literature identified relevant existing measures, symptoms, and impacts of RSV. A draft version of the RSV-iiiQ was developed based on the Influenza Intensity and Impact Questionnaire (Flu-iiQ) with expert input. Qualitative interviews (N = 20) were conducted with participants to optimize the RSV-iiiQ conceptual model and confirm the content validity of the RSV-iiiQ. Interviews included concept elicitation and a cognitive debriefing assessment. A draft conceptual framework was developed, and the electronic clinical outcome assessment was piloted. All steps of instrument development followed Food and Drug Administration guidance for patient-reported outcomes. RESULTS: In-depth concept elicitation interviews followed by cognitive debriefings demonstrated that the content of the items was comprehensive, covered the breadth of RSV symptoms and impacts, and was relevant to the experiences of individuals with RSV. Both the paper and electronic versions of the RSV-iiiQ were easily completed. Minor refinements were made to some items based on participant feedback, and the draft conceptual framework was refined. CONCLUSIONS: The RSV-iiiQ was developed for use in clinical trials to measure the symptom intensity and impact of acute RSV infection from the perspective of adult patients. The tool was developed in accordance with current regulatory guidance and is useful to support patient-focused drug development.


Subject(s)
Influenza Vaccines , Influenza, Human , Respiratory Syncytial Virus Infections , United States , Humans , Aged , Quality of Life , Patient Reported Outcome Measures
8.
Qual Life Res ; 32(5): 1277-1293, 2023 May.
Article in English | MEDLINE | ID: mdl-36371770

ABSTRACT

PURPOSE: To compare the performance of anchor-based methods for estimating thresholds of meaningful within-patient change (i.e., individual change) of clinical outcome assessments in conditions reflecting data characteristics of small- to medium-sized clinical trials. METHODS: Datasets were generated from the joint distributions of the PROMIS PF 20a T-score changes and a seven-point global change anchor measure. The 108 simulation conditions (1000 replications per condition) included combinations of three marginal distributions of T-score changes, three improvement percentages in the anchor measure, four levels of responsiveness correlations, and three sample sizes. Threshold estimation methods included mean change, median change, ROC curve, predictive modeling, half SD, and SEM. Relative bias, precision, accuracy, and measurement significance of the estimates were evaluated based on comparison with true thresholds and IRT-based individual reliable changes of PROMIS scores. Quantile regression models were applied to select and interpret effects of simulation conditions on estimation bias. RESULTS: When PROMIS T-score changes were distributed normally, the predictive modeling method performed best with 50% or more responders identified by the anchor; the mean and median methods were preferred with 30% responders. For skewed distributions, the median method and ROC method gained more advantages. Among the evaluated study conditions, the improvement percentage condition had the most obvious effects on estimation bias. CONCLUSION: To establish accurate and precise thresholds, clinical researchers are recommended to prioritize study designs with at least 50% anchor-defined responders and strongly responsive target endpoints with highly reliable scoring calibration and to select optimal anchor-based methods given the data characteristics.


Subject(s)
Patient Reported Outcome Measures , Quality of Life , Humans , Quality of Life/psychology , Minimal Clinically Important Difference
9.
MSMR ; 29(4): 8-14, 2022 04 01.
Article in English | MEDLINE | ID: mdl-35608520

ABSTRACT

In 2021, there were 488 incident cases of heat stroke and 1,864 incident cases of heat exhaustion among active component service members of the U.S. Armed Forces. The unadjusted annual rates of incident heat stroke and heat exhaustion peaked in 2018 and then declined in 2019 and 2020. Between 2020 and 2021, the rate of incident heat stroke was relatively stable (0.37 cases per 1,000 person-years [p-yrs]) while the rate of heat exhaustion increased slightly (1.40 cases per 1,000 p-yrs). In 2021, subgroup-specific rates of incident heat stroke and heat exhaustion were highest among male service members, those less than 20 years old, Marine Corps and Army members, recruit trainees, and those in combat-specific occupations. During 2017­2021, a total of 312 heat illnesses were documented among service members in the U.S. Central Command (CENTCOM) area of responsibility (AOR); 6.4% (n=20) were diagnosed as heat stroke. Commanders, small unit leaders, training cadre, and supporting medical personnel must ensure that the military members whom they supervise and support are informed about the risks, preventive countermeasures, early signs and symptoms, and first-responder actions related to heat illnesses.


Subject(s)
Heat Exhaustion , Heat Stress Disorders , Heat Stroke , Military Personnel , Adult , Afghan Campaign 2001- , Heat Stress Disorders/epidemiology , Heat Stroke/epidemiology , Humans , Incidence , Iraq War, 2003-2011 , Male , Population Surveillance , United States/epidemiology , Young Adult
12.
Clin Obes ; 11(5): e12477, 2021 Oct.
Article in English | MEDLINE | ID: mdl-34296522

ABSTRACT

The Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) was developed to assess weight-related physical and psychosocial functioning in the context of clinical trials. Data from two pivotal trials of once-weekly subcutaneous semaglutide for the purpose of weight management (NCT03548935 and NCT03552757) were analysed to confirm the structure, reliability, validity, and responsiveness of the IWQOL-Lite-CT and evaluate the magnitude of meaningful within-patient change in patients with overweight or obesity, with and without type 2 diabetes. Factor analyses and inter-item correlations confirmed the IWQOL-Lite-CT structure and scoring algorithm. Each composite score (physical, physical function, psychosocial, and total) demonstrated excellent internal consistency (Cronbach's alphas ≥ 0.82) and test-retest reliability (intraclass correlation coefficients ≥ 0.85) in both trials. Patterns of cross-sectional and longitudinal construct validity correlations were generally consistent with hypotheses. Each of the IWQOL-Lite-CT composites was able to discriminate between known groups. Effect sizes and paired t tests comparing IWQOL-Lite-CT scores at baseline and Week 68 were statistically significant for all composites in both trials (P < 0.0001), providing strong support for the ability to detect change. Results of anchor-based analyses supported responder thresholds ranging from 13.5 to 16.6 across composite scores. The IWQOL-Lite-CT, a comprehensive assessment of weight-related functioning from the patient perspective, is appropriate for use in clinical trials evaluating the efficacy of new treatments for weight management.


Subject(s)
Diabetes Mellitus, Type 2 , Quality of Life , Body Mass Index , Cross-Sectional Studies , Humans , Psychometrics , Reproducibility of Results , Surveys and Questionnaires , Tomography, X-Ray Computed
13.
MSMR ; 28(4): 27-38, 2021 Apr.
Article in English | MEDLINE | ID: mdl-33975438

ABSTRACT

During 1 January 2016-30 September 2020, there were 210,914 incident cases of skin and soft tissue infections (SSTIs) among active component U.S. military members, corresponding to a crude overall incidence rate of 352.8 per 10,000 person-years (p-yrs). An additional 4,250 cases occurred in theaters of operations (251.0 per 10,000 p-yrs). Of the total incident SSTI diagnoses, 64.5% were classified as cellulitis/abscess, 30.0% were "other SSTIs" (e.g., folliculitis, impetigo), 5.3% were carbuncles/furuncles, and 0.2% were erysipelas. Crude annual incidence rates declined by 21.9% over the surveillance period. In general, higher rates of SSTIs were associated with younger age, recruit/trainee status, and junior enlisted rank. A total of 174,893 service members were treated for SSTIs, which accounted for 307,160 medical encounters and 14,819 hospital bed days. SSTIs in the military are associated with significant operational and health care burden. Strategies for the prevention, early diagnosis, and definitive treatment of SSTIs are warranted, particularly in initial military training and operational settings associated with increased risk of infection.


Subject(s)
Carbuncle , Military Personnel , Soft Tissue Infections , Cellulitis/epidemiology , Humans , Incidence , Population Surveillance , Soft Tissue Infections/epidemiology , United States/epidemiology
14.
Neurology ; 96(12): e1595-e1607, 2021 03 23.
Article in English | MEDLINE | ID: mdl-33597289

ABSTRACT

OBJECTIVE: To assess long-term (2 years) effects of bimagrumab in participants with sporadic inclusion body myositis (sIBM). METHODS: Participants (aged 36-85 years) who completed the core study (RESILIENT [Efficacy and Safety of Bimagrumab/BYM338 at 52 Weeks on Physical Function, Muscle Strength, Mobility in sIBM Patients]) were invited to join an extension study. Individuals continued on the same treatment as in the core study (10 mg/kg, 3 mg/kg, 1 mg/kg bimagrumab or matching placebo administered as IV infusions every 4 weeks). The co-primary outcome measures were 6-minute walk distance (6MWD) and safety. RESULTS: Between November 2015 and February 2017, 211 participants entered double-blind placebo-controlled period of the extension study. Mean change in 6MWD from baseline was highly variable across treatment groups, but indicated progressive deterioration from weeks 24-104 in all treatment groups. Overall, 91.0% (n = 142) of participants in the pooled bimagrumab group and 89.1% (n = 49) in the placebo group had ≥1 treatment-emergent adverse event (AE). Falls were slightly higher in the bimagrumab 3 mg/kg group vs 10 mg/kg, 1 mg/kg, and placebo groups (69.2% [n = 36 of 52] vs 56.6% [n = 30 of 53], 58.8% [n = 30 of 51], and 61.8% [n = 34 of 55], respectively). The most frequently reported AEs in the pooled bimagrumab group were diarrhea 14.7% (n = 23), involuntary muscle contractions 9.6% (n = 15), and rash 5.1% (n = 8). Incidence of serious AEs was comparable between the pooled bimagrumab and the placebo group (18.6% [n = 29] vs 14.5% [n = 8], respectively). CONCLUSION: Extended treatment with bimagrumab up to 2 years produced a good safety profile and was well-tolerated, but did not provide clinical benefits in terms of improvement in mobility. The extension study was terminated early due to core study not meeting its primary endpoint. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov identifier NCT02573467. CLASSIFICATION OF EVIDENCE: This study provides Class IV evidence that for patients with sIBM, long-term treatment with bimagrumab was safe, well-tolerated, and did not provide meaningful functional benefit. The study is rated Class IV because of the open-label design of extension treatment period 2.


Subject(s)
Antibodies, Monoclonal, Humanized/therapeutic use , Myositis, Inclusion Body/drug therapy , Accidental Falls , Adult , Aged , Aged, 80 and over , Double-Blind Method , Female , Humans , Male , Middle Aged , Muscle Strength/drug effects , Myositis, Inclusion Body/complications , Time , Treatment Outcome , Walk Test
15.
MSMR ; 28(12): 2-13, 2021 Dec.
Article in English | MEDLINE | ID: mdl-35320662

ABSTRACT

Osteoarthritis (OA) is the most common adult joint disease and accounts for significant morbidity burdens among U.S. civilian and military populations. During 2016-2020, the crude overall rates of incident OA and spondylosis diagnoses among U.S. active component service members were 630.9 per 100,000 person-years (p-yrs) and 958.2 per 100,000 p-yrs, respectively. Crude annual rates of both conditions decreased markedly from 2016 through 2020 with declines evident in all of the demographic and military subgroups examined. Compared to their respective counterparts, crude overall rates of OA diagnoses were highest among male service members, those aged 35 or older, non-Hispanic Black service members, Army members, and those working in health care occupations. Crude overall rates of spondylosis diagnoses were highest among those aged 30 or older, non-Hispanic White and non-Hispanic Black service members, Army members, and those in health care and communications/intelligence occupations. More than two-thirds of all incident OA diagnoses involved the knee (38.8%) or shoulder (28.4%). Differences in anatomic site-specific rates of OA were apparent by sex, race/ethnicity group, service, and military occupation. Additional research to identify military-specific equipment and activities that increase the risk of acute and chronic damage to joints would be useful to develop, test, and implement practical and effective countermeasures against OA and spondylosis among military members in general and those in high-risk occupations specifically.


Subject(s)
Military Personnel , Osteoarthritis , Spondylosis , Adult , Ethnicity , Humans , Male , Osteoarthritis/epidemiology , Spondylosis/epidemiology
16.
J Clin Sleep Med ; 17(4): 691-701, 2021 04 01.
Article in English | MEDLINE | ID: mdl-33206043

ABSTRACT

STUDY OBJECTIVES: The Nocturia Sleep Quality Scale (NSQS), a novel patient-reported outcomes measure, was developed to assess the impact of sleep disturbance from nocturia. The objective of this study was to assess the psychometric properties of the NSQS, including its structure, reliability, and validity. METHODS: Data were collected in the context of a web-based, prospective, longitudinal, observational study. Participants with nocturia were randomized 1:1 to either a group that received sleep hygiene instructions, including instructions to limit liquids at nighttime and empty bladder prior to bedtime, or one that did not receive sleep instructions. All participants were asked to provide responses to the web-based questionnaires from day 1 to day 10. Psychometric analyses, aligned with current regulatory guidance, were conducted to evaluate the daily scores and 3-day average scores of NSQS items and potential composites. Item-level analyses were conducted first, followed by composite-level analyses. RESULTS: The NSQS items and supporting measures demonstrated very slight improvement in patient-perceived sleep disturbance from nocturia over the course of the study. NSQS test-retest reliabilities were generally satisfactory. Correlations between NSQS items and related patient-reported measures tended to support the construct validity of the NSQS, and the known-groups analyses supplied evidence of its discriminating ability. NSQS responsiveness statistics were small. CONCLUSIONS: The NSQS is a reliable and valid measure of the impact of nocturia on patients' sleep. The present analyses lay the psychometric groundwork for the use of the NSQS in future clinical trials to support product approval and labeling claims.


Subject(s)
Nocturia , Humans , Prospective Studies , Psychometrics , Quality of Life , Reproducibility of Results , Sleep , Surveys and Questionnaires
17.
MedEdPORTAL ; 16: 11011, 2020 11 11.
Article in English | MEDLINE | ID: mdl-33204835

ABSTRACT

Introduction: Increasing faculty and leader diversity has been recommended as a way for health care organizations to achieve cultural competence in their patient care mission. Given the low numbers of underrepresented groups in medical school leadership positions, teaching diverse students and trainees the concept of leadership as influence may empower them to become more involved and bring diverse perspectives to their organizations. Methods: This 70-minute workshop consisted of a short presentation, a self-assessment, small- and large-group discussions, and case studies to: (1) describe the importance of diversity in medical school leadership, (2) define leadership, (3) define self-leadership, and (4) assess one's own self-leadership skills. The workshop was implemented at three US medical schools to diverse medical students and residents between September and December of 2019. Pre- and postworkshop evaluations were analyzed. Results: Greater than 95% of learners (n = 66) agreed that the workshop's learning objectives were met. Comments suggested participants appreciated learning about the lack of diversity among medical school leaders and the importance of cultivating their role in diversity in academic medicine. The case studies were highly rated and considered effective tools for learning. Discussion: This submission defined an empowering notion of leadership as influence. It taught learners that we can all lead (by influence) if we can improve our own self-leadership skills and become involved and bring diverse perspectives to health care organizations. Future research may focus on longer-term follow-up of participants to reassess their self-leadership skills and describe their level of involvement in their organizations.


Subject(s)
Leadership , Students, Medical , Delivery of Health Care , Humans , Schools, Medical , Workforce
18.
MSMR ; 27(10): 9-19, 2020 10.
Article in English | MEDLINE | ID: mdl-33112157

ABSTRACT

Pancreatitis is an inflammatory disease of the pancreas resulting from the premature activation of digestive enzymes within the pancreas. Pancreatitis occurs in both acute and chronic forms. During 2004-2018, a total of 6,471 U.S. active component service members received incident diagnoses of acute pancreatitis (AP), for a crude overall incidence rate of 31.8 per 100,000 person- years (p-yrs). Compared to their respective counterparts, overall rates of AP diagnoses were highest among females, those in older age groups, non-Hispanic blacks, Army members, and those working in healthcare occupations. Crude annual rates of AP diagnoses increased by 25.5% over the 15-year period; this trend was driven largely by a rise in outpatient rates. Of the total incident cases of AP, 9.0% received a subsequent incident diagnosis of chronic pancreatitis (CP) during the surveillance period. Between 2004 and 2018, the crude overall incidence rate of CP was 4.4 per 100,000 p-yrs. Patterns of overall rates of CP by demographic and military characteristics were generally similar to those for AP. Crude annual rates of CP fluctuated between 3.7 per 100,000 p-yrs and 5.7 per 100,000 p-yrs during the surveillance period, with no pronounced overall trend over time. To inform preventive and therapeutic strategies, continued research is needed to understand the factors that increase risk of progression from AP to CP and the importance of the interaction between genetic and environmental factors in this transition.


Subject(s)
Military Personnel/statistics & numerical data , Occupational Diseases/epidemiology , Pancreatitis, Chronic/epidemiology , Pancreatitis/epidemiology , Population Surveillance , Acute Disease , Adult , Female , Humans , Incidence , Male , Middle Aged , United States/epidemiology , Young Adult
19.
MSMR ; 27(8): 9-14, 2020 08.
Article in English | MEDLINE | ID: mdl-32876467

ABSTRACT

Laboratory, reportable medical event, and medical encounter data were analyzed to identify cases of acute gastrointestinal (GI) infections caused by Campylobacter, nontyphoidal Salmonella, Shigella, Escherichia coli (E. coli), or norovirus, as well as cases of unspecified gastroenteritis/diarrhea among U.S. active component service members during 2010-2019. Unspecified gastroenteritis/ diarrhea diagnoses accounted for 98.8% of identified incident cases (4,135.1 cases per 100,000 person-years [p-yrs]). Campylobacter was the most frequently identified specific etiology (17.6 cases per 100,000 p-yrs), followed by nontyphoidal Salmonella (12.7 cases per 100,000 p-yrs), norovirus (10.8 cases per 100,000 p-yrs), E. coli (7.5 cases per 100,000 p-yrs), and Shigella (3.2 cases per 100,000 p-yrs). Crude annual rates of norovirus, E. coli, Campylobacter, and Salmonella infections and unspecified gastroenteritits/diarrhea increased between 2010 and 2019 while rates of Shigella infections were relatively stable. Among deployed service members during the 10-year period, only 150 cases of the 5 specific causes of gastroenteritis were identified but a total of 20,377 cases of unspecified gastroenteritis/diarrhea were diagnosed (3,062.9 per 100,000 deployed p-yrs).


Subject(s)
Gastroenteritis/epidemiology , Military Personnel/statistics & numerical data , Adult , Caliciviridae Infections/epidemiology , Campylobacter Infections/epidemiology , Cross-Sectional Studies , Diarrhea/epidemiology , Dysentery, Bacillary/epidemiology , Escherichia coli Infections/epidemiology , Female , Humans , Male , Middle Aged , Salmonella Infections/epidemiology , United States/epidemiology , Young Adult
20.
J Fac Dev ; 34(2): 33-43, 2020 May.
Article in English | MEDLINE | ID: mdl-32714626

ABSTRACT

The Oklahoma Center for Mentoring Excellence (OCME) initiated faculty workshops to enhance their mentoring skills and establish an intercampus network for faculty specializing in clinical and biomedical sciences. The initial importance of mentoring competencies based on early career faculty members' perception and experience had not yet been determined. The Mentoring Competency Assessment validated by Fleming et al. (2013b) was used to rate the perceived importance of competencies and assess senior faculty members' competencies using a seven-point range, Likert-type response scale. Responses were analyzed by presence or absence of a mentor, previous formal mentor training, sex, and health science discipline. Junior faculty (n = 144) rated each competency as important or greater across all categories. A majority (70%) reported not having a current mentor. Junior faculty with current mentors rated senior faculty competencies higher than junior faculty without; participation in formal mentor training as well as a clinical faculty appointment were independently associated with higher assessment scores. This study identifies specific population characteristics that may serve to enhance the effectiveness of OCME workshops and demonstrates that junior faculty identify mentoring as significantly important in their academic career success in a research and clinical health setting.

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