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1.
J Nurs Adm ; 54(3): 142-147, 2024 Mar 01.
Article in English | MEDLINE | ID: mdl-38349893

ABSTRACT

Nursing assistants are vital healthcare team members who often experience personal challenges to professional success. The Transformational Healthcare Readiness through Innovative Vocational Education (THRIVE) program is designed to combat these challenges through coaching and curriculum that is steeped in adult learning and social theories. The program's goal is to increase retention and success of newly hired nursing assistants through personal and professional support. Components of THRIVE can be adapted in a variety of healthcare settings.


Subject(s)
Curriculum , Nursing Assistants , Adult , Humans , Delivery of Health Care , Learning , Hospitals
2.
Gerontologist ; 64(4)2024 Apr 01.
Article in English | MEDLINE | ID: mdl-37480588

ABSTRACT

BACKGROUND AND OBJECTIVES: Few data on caregiving during the coronavirus disease 2019 pandemic use an intersectional lens to attend to how multiple social categories, such as gender, age, race, and sexual orientation, shape caregiving experiences. This analysis sought to explore caregiving experiences of aging Black same-gender-loving women. RESEARCH DESIGN AND METHODS: Sixteen focus groups were conducted with 4-8 participants each (N = 102) from across the United States. Audio-recorded discussions lasted for approximately 90 min and were transcribed verbatim. Two analysts coded transcripts for discussions related to caregiving and used content analysis to identify themes. RESULTS: Participants engaged in caregiving for children, parents, family, friends, and neighbors. They provided physical, economical, instrumental, and/or secondary caregiving; and sometimes received care themselves. The pandemic heavily affected their stress level and mental health as well as their intimate partner relationships. Discussions mostly offered descriptions of increased caregiving difficulty caused by the pandemic. However, a few participants identified ways the pandemic made caregiving easier; changed caregiving without making it easier or harder; or thwarted their ability to provide care. DISCUSSION AND IMPLICATIONS: Older Black same-gender-loving women described some pandemic caregiving experiences that diverged from the existing literature, demonstrating the importance of considering how gender, race, age, and sexual orientation affect caregiving experiences during a pandemic fraught with health inequities. Ensuring the multiply marginalized caregivers have access to the practical and emotional support they need is critical for advancing health equity and preparing for future pandemics.


Subject(s)
COVID-19 , Pandemics , Male , Female , Humans , COVID-19/epidemiology , Qualitative Research , Focus Groups , Aging
3.
LGBT Health ; 11(3): 219-228, 2024 Apr.
Article in English | MEDLINE | ID: mdl-37971831

ABSTRACT

Purpose: This study describes prevalence of caregiving before and after the onset of the COVID-19 pandemic among racially diverse older cisgender sexual minority women, examines factors associated with caregiving, and assesses relationships between caregiving and health. Methods: A convenience sample of participants aged ≥50 years completed self-administered online surveys assessing sociodemographic characteristics, caregiver status, self-rated health, and depressive symptoms. Bivariate statistics compared response variables by race, caregiver status, and timing of caregiving relative to the pandemic. Results: Of 365 participants, 82.7% identified as lesbian or gay and 41.1% as Black/African American; 40% were caregivers before (n = 32), during (n = 34), or both before and during (n = 80) the pandemic. A greater proportion of caregivers lived with a partner (45.9% vs. 35.6%, p = 0.06), were unemployed (37.7% vs. 29.7%, p = 0.07), and had high school or lower education (11.6% vs. 5%, p = 0.09). No differences were found in self-rated health by caregiver status; however, a higher proportion of Black (vs. White) caregivers reported good to excellent physical health (77.9% vs. 62.9%, p = 0.05). Caregivers more frequently reported depressive symptoms (28.1% vs. 17.8%, p = 0.03). Caregivers both before and during the pandemic had lower educational attainment than those who provided care only before or only during the pandemic (p = 0.04). Conclusion: Caregiving was common among older sexual minority women during the pandemic and experiences varied by race and other social factors. Consideration of these intersecting experiences is important for fully understanding caregiver experiences during COVID-19. Overall, caregiving was associated with depressive symptoms, underscoring the importance of psychosocial support for all caregivers.


Subject(s)
COVID-19 , Sexual and Gender Minorities , Humans , Female , United States/epidemiology , Cross-Sectional Studies , Pandemics , Surveys and Questionnaires
5.
Qual Manag Health Care ; 32(3): 137-144, 2023.
Article in English | MEDLINE | ID: mdl-36201721

ABSTRACT

BACKGROUND AND OBJECTIVES: Clinician workload is a key contributor to burnout and well-being as well as overtime and staff shortages, particularly in the primary care setting. Appointment volume is primarily driven by the size of patient panels assigned to clinicians. Thus, finding the most appropriate panel size for each clinician is essential to optimization of patient care. METHODS: One year of appointment and panel data from the Department of Family Medicine were used to model the optimal panel size. The data consisted of 82 881 patients and 105 clinicians. This optimization-based modeling approach determines the panel size that maximizes clinician capacity while distributing heterogeneous appointment types among clinician groups with respect to their panel management time (PMT), which is the percent of clinic work. RESULTS: The differences between consecutive PMT physician groups in total annual appointment volumes per clinician for the current practice range from 176 to 348. The optimization-based approach for the same PMT physician group results in having a range from 211 to 232 appointments, a relative reduction in variability of 88%. Similar workload balance gains are also observed for advanced practice clinicians and resident groups. These results show that the proposed approach significantly improves both patient and appointment workloads distributed among clinician groups. CONCLUSION: Appropriate panel size has valuable implications for clinician well-being, patients' timely access to care, clinic and health system productivity, and the quality of care delivered. Results demonstrate substantial improvements with respect to balancing appointment workload across clinician types through strategic use of an optimization-based approach.


Subject(s)
Burnout, Professional , Workload , Humans , Primary Health Care , Appointments and Schedules , Ambulatory Care Facilities
6.
Mayo Clin Proc Innov Qual Outcomes ; 6(5): 475-483, 2022 Oct.
Article in English | MEDLINE | ID: mdl-36160638

ABSTRACT

Objective: To address the problem of limited health care access for patients in rural southern Minnesota, a digitally capable mobile health clinic (MHC) quality improvement initiative was launched in a rural community-based health system. Methods: This project was designed and implemented according to our institutional strategic plan, guiding principles for virtual community care, and existing approved standards of care. A quality improvement development and pilot implementation framework was rapidly developed using Agile methodology. Results: The resulting technology and equipment selection, overall clinic design, vehicle vendor selection, clinical schedule and workflows, staffing model, equipment and technology selection, and testing were achieved in 12 months. The pilot site communities were chosen on the basis of size, interest, and lack of existing access. Four underserved rural communities now have access to telehealth consultations, laboratory testing, and in-person primary care examinations. By April 30, 2022, the MHC had provided 1498 patient appointments while maintaining our standards of care. Newly established broadband internet access for these communities and their residents was a valuable secondary outcome. Conclusion: By designing and implementing an MHC quality improvement intervention that provides both in-person and advanced telehealth options for patients in rural communities, our institution rapidly provided a potential solution for the rural health care crisis. The MHC not only replaces traditional brick-and-mortar facilities but also expands service offerings and access to technology for rural communities and the people who live and work in them.

7.
J Prim Care Community Health ; 12: 21501327211037773, 2021.
Article in English | MEDLINE | ID: mdl-34355598

ABSTRACT

OBJECTIVES: Health literacy is an individual's capacity to obtain, process, and understand basic health information needed to make appropriate health decisions. Failure to understand and correctly execute a plan of care often leads to poor health outcomes. Determining patient health literacy allows health care providers to tailor their plan of care instructions, increasing the probability of understanding, and adherence. Several validated health literacy tests have been developed to assess the health literacy of individuals and ethnic groups. However, because a proctor is required to administer these tests, their usefulness in clinical settings is limited. The issue of health literacy is especially relevant within minority groups. This research focused on producing a translatable assessment that can be administered quickly without a proctor. METHODS: We developed a 15-question instrument (the RIHLA) in English using the Delphi method with a panel of bilingual experts and translated it into Spanish. Internal reliability was assessed using Cronbach's alpha for 3 groups: Native English-speaking College students (NESC), Native English-speaking patients (NES), and Limited English Proficient Spanish-speaking patients (LEP). External validity was assessed using Pearson's correlation coefficient to compare our instrument to a previously validated, proctored instrument measuring health literacy (the SAHL-E). RESULTS: Four hundred fifteen subjects completed the RIHLA. Of these, 192 (46.3%) were NESC, 208 (50.1%) were NES, and 15 (3.6%) were LEP. The mean number of correct answers was 11.2, 11.6, and 8.3 respectively with the LEP group scoring lower (P < .01). Cronbach's alpha was >.70 for each group. Moderate correlation between the RIHLA and the previously validated instrument was present (P < .01) with Pearson's r = .47 (95% CI: 0.18-0.69). CONCLUSION: The RIHLA is a non-proctored assessment tool that may provide a measure of patients' health literacy in multiple languages. Further studies with larger sample sizes are necessary to confirm the reliability, validity, and generalizability to a wider population.


Subject(s)
Health Literacy , Language , Humans , Pilot Projects , Reproducibility of Results
8.
J Patient Exp ; 8: 23743735211034037, 2021.
Article in English | MEDLINE | ID: mdl-34368431

ABSTRACT

Known gaps exist between what patients value and institutions prioritize. We sought to incorporate patients' reasons for valuing family medicine into a new Mission and Vision statement by deploying brief surveys to a convenience sample of patients. We conducted descriptive quantitative analyses of demographics and inductive content analysis of written responses. Patients returned 92 (20%) of 450 questionnaires. Responders were 63% female, mean age of 47 years. Patients noted distinguishing features of family medicine were (1) continuity of care, (2) all-encompassing care, and (3) trusted referrals. Some patients reported not knowing there was a distinction between family medicine and other primary care.

9.
JCO Oncol Pract ; 17(8): e1202-e1214, 2021 08.
Article in English | MEDLINE | ID: mdl-34375560

ABSTRACT

PURPOSE: Optimal cancer care requires patient self-management and coordinated timing and sequence of interdependent care. These are challenging, especially in safety-net settings treating underserved populations. We evaluated the 4R Oncology model (4R) of patient-facing care planning for impact on self-management and delivery of interdependent care at safety-net and non-safety-net institutions. METHODS: Ten institutions (five safety-net and five non-safety-net) evaluated the 4R intervention from 2017 to 2020 with patients with stage 0-III breast cancer. Data on self-management and care delivery were collected via surveys and compared between the intervention cohort and the historical cohort (diagnosed before 4R launch). 4R usefulness was assessed within the intervention cohort. RESULTS: Survey response rate was 63% (422/670) in intervention and 47% (466/992) in historical cohort. 4R usefulness was reported by 79.9% of patients receiving 4R and was higher for patients in safety-net than in non-safety-net centers (87.6%, 74.2%, P = .001). The intervention cohort measured significantly higher than historical cohort in five of seven self-management metrics, including clarity of care timing and sequence (71.3%, 55%, P < .001) and ability to manage care (78.9%, 72.1%, P = .02). Referrals to interdependent care were significantly higher in the intervention than in the historical cohort along all six metrics, including primary care consult (33.9%, 27.7%, P = .045) and flu vaccination (38.6%, 27.9%, P = .001). Referral completions were significantly higher in four of six metrics. For safety-net patients, improvements in most self-management and care delivery metrics were similar or higher than for non-safety-net patients, even after controlling for all other variables. CONCLUSION: 4R Oncology was useful to patients and significantly improved self-management and delivery of interdependent care, but gaps remain. Model enhancements and further evaluations are needed for broad adoption. Patients in safety-net settings benefited from 4R at similar or higher rates than non-safety-net patients, indicating that 4R may reduce care disparities.


Subject(s)
Breast Neoplasms , Self-Management , Breast Neoplasms/therapy , Delivery of Health Care , Female , Humans , Medical Oncology , Primary Health Care
10.
Popul Health Manag ; 24(4): 502-508, 2021 08.
Article in English | MEDLINE | ID: mdl-33216689

ABSTRACT

The objective was to determine if a greater proportion of physician full-time equivalent (FTE%) relative to nurse practitioners/physician assistants (NPs/PAs) on care teams was associated with improved individual clinician diabetes quality outcomes. The authors conducted a retrospective cross-sectional study of 420 family medicine clinicians in 110 care teams in a Midwest health system, using administrative data from January 1, 2017 to December 31, 2017. Poisson regression was used to examine the relationship between physician FTE% and the number of patients meeting 5 criteria included in a composite metric for diabetes management (D5). Covariates included panel size, clinician type, sex, years in practice, region, patient satisfaction, care team size, rural location, and panel complexity. Of the 420 clinicians, 167 (40%) were NP/PA staff and 253 (60%) were physicians. D5 criteria were achieved in 37.9% of NP/PA panels compared with 44.5% of physician panels (P < .001). In adjusted analysis, rate of patients achieving D5 was unrelated to physician FTE% on the care team (P = .78). Physicians had a 1.082 (95% confidence interval 1.007-1.164) times greater rate of patients with diabetes achieving D5 than NPs/PAs. Clinicians at rural locations had a .904 (.852-.959) times lower rate of achieving D5 than those at urban locations. Physicians had a greater rate of patients achieving D5 compared with NPs/PAs, but physician FTE% on the care team was unrelated to D5 outcomes. This suggests that clinician team composition matters less than team roles and the dynamics of collaborative care between members.


Subject(s)
Diabetes Mellitus , Nurse Practitioners , Physician Assistants , Cross-Sectional Studies , Diabetes Mellitus/epidemiology , Diabetes Mellitus/therapy , Humans , Patient Care Team , Retrospective Studies
11.
Mayo Clin Proc Innov Qual Outcomes ; 4(2): 135-142, 2020 Apr.
Article in English | MEDLINE | ID: mdl-32280923

ABSTRACT

OBJECTIVE: To determine the relationship of the emotional exhaustion domain of burnout with care team composition in a Midwestern primary care practice network. PARTICIPANTS AND METHODS: We studied 420 family medicine clinicians (253 physicians and 167 nurse practitioners/physician assistants [NP/PAs]) within a large integrated health system throughout 59 Midwestern communities. The observational cross-sectional study utilized a single-question clinician self-assessment of the emotional exhaustion domain of burnout on a scale of 0 (never) to 6 (daily) conducted between March 1 and April 2, 2018, and administrative data collected between January 1, 2017, and December 31, 2017. We used a multivariable linear mixed model for data analysis, adjusted for clinical- and team-level factors, including clinician sex, panel size and complexity, clinician type (physician or NP/PA), clinician full-time equivalent (FTE), total care team panel size, and number of clinicians on the care team. RESULTS: Among 217 survey respondents (51.7%), the median frequency of the emotional exhaustion domain of burnout was once per week. Adjusted analyses revealed that a greater proportion of physician FTE on the care team was associated with a lower emotional exhaustion domain of burnout among individual clinicians (P=.05). Female clinicians had a higher emotional exhaustion domain of burnout than male clinicians (P=.05). None of the other variables in the model were associated with emotional exhaustion. CONCLUSION: Primary care teams containing both physicians and NP/PAs had lower levels of emotional exhaustion with increasing proportion of physician FTE. More work is needed to explore what other variables may be associated with burnout in primary care team-based practices.

12.
J Prim Care Community Health ; 10: 2150132719840517, 2019.
Article in English | MEDLINE | ID: mdl-31027438

ABSTRACT

INTRODUCTION: Hospitalists have been shown to have shorter lengths of stays than physicians with concurrent outpatient practices. However, hospitalists at academic medical centers may be less aware of local resources that can support the hospital to home transition for local primary care patients. We hypothesized that local family medicine patients admitted to a family medicine inpatient service have shorter length of stay than those admitted to general hospitalist services which also care for tertiary patients at an academic medical center. METHODS: A retrospective cohort study was conducted at an academic medical center with a department of family medicine providing primary care to over 80 000 local patients. A total of 3100 consecutive family medicine patients admitted to either the family medicine inpatient service or a general medicine inpatient service over 3 years were studied. The primary outcome was length of stay, which was adjusted using multivariate linear regression for demographics, prior utilization, diagnosis, and disease severity. RESULTS: Adjusted length of stay was 33% longer (95% CI 24%-44%) for local family medicine patients admitted to general medicine inpatient services as compared with the family medicine inpatient service. Readmission rates within 30 days were not different (19% vs 16%, P = .14). CONCLUSIONS: Local primary care patients were safely discharged from the hospital sooner on the family medicine inpatient service than on general medicine inpatient services. This is likely because the family physicians staffing their inpatient service are more familiar with outpatient resources that can be effectively marshaled to help local patients with the transition from hospital to home.


Subject(s)
Family Practice , Hospitalists , Length of Stay/statistics & numerical data , Physicians, Family , Academic Medical Centers , Adult , Aged , Female , Hospital Departments , Hospitalization , Humans , Linear Models , Male , Middle Aged , Multivariate Analysis , Retrospective Studies , Transitional Care
13.
J Manag Care Spec Pharm ; 25(3): 392-401, 2019 Mar.
Article in English | MEDLINE | ID: mdl-30816820

ABSTRACT

BACKGROUND: The misuse of prescription drugs is a serious public health problem. Although controlled substance (CS) prescribing, in particular, opioid analgesics, has recently declined, the volume of prescriptions in 2015 was still 3 times higher than in 1999. To curb the high volume of CS prescribing, a national health plan has implemented a controlled substance utilization management (CSUM) program, a prescriber-focused educational intervention regarding patients at risk for CS misuse. OBJECTIVE: To characterize the effect of the CSUM program on CS prescribing volumes, number of prescribers and other health outcomes (opioid overdoses, all-cause emergency department visits, and all-cause hospitalizations). METHODS: The CSUM program identified patients who received ≥10 CS prescriptions within any 3-month window for noncancer pain as being high risk for CS misuse and mailed patient medication profiles to their CS prescribers. This retrospective study was conducted on patients whose prescribers were contacted by the CSUM program from January 2014 to December 2015. The reference group included patients with carved-out pharmacy benefits who were 1:1 propensity score matched to the program group. CS prescribing volumes, number of CS prescribers, and other health care utilization measures were assessed in the 6-month pre-intervention (baseline) period and 6-month post-intervention (follow-up) period using difference-in-difference (DID) analysis. RESULTS: After matching, each group had 17,295 patients, and there were no differences in baseline demographic and clinical characteristics. During the follow-up period, the CSUM group had 1.1 fewer prescriptions for CS (mean difference [MD] within group -3.2 vs. -2.1 prescriptions), 21 fewer days of supply (MD -27 vs. -6 days), and 0.2 fewer number of CS prescribers (MD -0.8 vs. -0.6 prescribers) per patient when compared with the reference group; all P values were < 0.001. The reductions in CS prescribing volumes and number of prescribers within the CSUM group were mainly driven by opioid analgesics, with minimal differences in benzodiazepines and stimulants between the 2 groups. The CSUM program had no significant effect on the opioid dosage strength but was associated with a lower rate of all-cause emergency department visits. CONCLUSIONS: The CSUM program had a moderate positive effect on reducing CS prescribing volumes and number of CS prescribers compared with a reference group. Beside the focus on patients who have already received 10+ CS prescriptions, there remains a need for more intensive approaches for accelerating targeted declines in CS in general and opioids in particular. DISCLOSURES: Funding for this study was provided by Anthem, which had no role in study design, data interpretation, manuscript development, or the decision to publish. Chen, Ma, Barron, DeVries, and Agiro are employees of HealthCore, a wholly owned subsidiary of Anthem. Horn is an employee of Anthem.


Subject(s)
Controlled Substances/administration & dosage , Drug Users , Practice Patterns, Physicians'/statistics & numerical data , Prescription Drug Misuse/prevention & control , Adult , Analgesics, Opioid/administration & dosage , Benzodiazepines/administration & dosage , Central Nervous System Stimulants/administration & dosage , Dose-Response Relationship, Drug , Education, Medical, Continuing/methods , Emergency Service, Hospital/statistics & numerical data , Female , Follow-Up Studies , Humans , Male , Middle Aged , Outcome Assessment, Health Care , Practice Patterns, Physicians'/standards , Retrospective Studies
15.
J Am Board Fam Med ; 29(4): 444-51, 2016.
Article in English | MEDLINE | ID: mdl-27390375

ABSTRACT

PURPOSE: The demand for comprehensive primary health care continues to expand. The development of team-based practice allows for improved capacity within a collective, collaborative environment. Our hypothesis was to determine the relationship between panel size and access, quality, patient satisfaction, and cost in a large family medicine group practice using a team-based care model. METHODS: Data were retrospectively collected from 36 family physicians and included total panel size of patients, percentage of time spent on patient care, cost of care, access metrics, diabetic quality metrics, patient satisfaction surveys, and patient care complexity scores. We used linear regression analysis to assess the relationship between adjusted physician panel size, panel complexity, and outcomes. RESULTS: The third available appointments (P < .01) and diabetic quality (P = .03) were negatively affected by increased panel size. Patient satisfaction, cost, and percentage fill rate were not affected by panel size. A physician-adjusted panel size larger than the current mean (2959 patients) was associated with a greater likelihood of poor-quality rankings (≤25th percentile) compared with those with a less than average panel size (odds ratio [OR], 7.61; 95% confidence interval [CI], 1.13-51.46). Increased panel size was associated with a longer time to the third available appointment (OR, 10.9; 95% CI, 1.36-87.26) compared with physicians with panel sizes smaller than the mean. CONCLUSIONS: We demonstrated a negative impact of larger panel size on diabetic quality results and available appointment access. Evaluation of a family medicine practice parameters while controlling for panel size and patient complexity may help determine the optimal panel size for a practice.


Subject(s)
Family Practice/statistics & numerical data , Health Services Accessibility/statistics & numerical data , Patient Satisfaction/statistics & numerical data , Primary Health Care/statistics & numerical data , Quality of Health Care/statistics & numerical data , Appointments and Schedules , Diabetes Mellitus/therapy , Family Practice/economics , Health Services Accessibility/economics , Humans , Primary Health Care/economics , Quality of Health Care/economics , Retrospective Studies , Surveys and Questionnaires
16.
Am J Audiol ; 21(2): 190-8, 2012 Dec.
Article in English | MEDLINE | ID: mdl-22718323

ABSTRACT

PURPOSE: The primary purpose of this investigation was to determine the relative frequency representation of binaural function in the brainstem and cortex of adults. The secondary purpose was to compare adult responses to previously reported infant responses. METHODS: Simultaneous auditory brainstem responses and auditory middle responses were recorded monaurally and binaurally in 20 young women. The binaural (BIN) response was subtracted from the summed monaural waves (L+R) to obtain the binaural interaction components (BIC) from waves V (peak A) and Pa (BIC-Pa). Amplitude ratios were calculated as BIC/L+R. Repeated-measures analyses of variance evaluated responses to frequency (500 Hz vs. 4000 Hz), wave condition (L+R vs. BIN), and wave class (auditory brainstem response vs. auditory middle response). RESULTS: Waveforms were present for all conditions. The L+R responses were larger than the BIN responses, 500 Hz produced larger amplitudes than 4000 Hz, and Pa was larger than wave V. The largest response, overall, was the Pa(L+R) response to 500 Hz. For amplitude ratios, BIC-Pa/Pa(L+R) was larger than Peak A/[V(L+R)]. CONCLUSION: More neural resources are devoted to binaural function in the cortex than in the brainstem, and more resources are devoted to lower frequencies than to higher frequencies. The adult data confirm that previously recorded infant data reveal binaural immaturity. Longitudinal data should characterize developmental characteristics of binaural function.


Subject(s)
Auditory Cortex/physiology , Brain Stem/physiology , Evoked Potentials, Auditory, Brain Stem/physiology , Evoked Potentials, Auditory/physiology , Acoustic Stimulation , Adult , Electroencephalography , Female , Functional Laterality/physiology , Humans , Infant , Young Adult
17.
Lancet ; 375(9714): 555-62, 2010 Feb 13.
Article in English | MEDLINE | ID: mdl-20116841

ABSTRACT

BACKGROUND: Emergency contraception can prevent unintended pregnancies, but current methods are only effective if used as soon as possible after sexual intercourse and before ovulation. We compared the efficacy and safety of ulipristal acetate with levonorgestrel for emergency contraception. METHODS: Women with regular menstrual cycles who presented to a participating family planning clinic requesting emergency contraception within 5 days of unprotected sexual intercourse were eligible for enrolment in this randomised, multicentre, non-inferiority trial. 2221 women were randomly assigned to receive a single, supervised dose of 30 mg ulipristal acetate (n=1104) or 1.5 mg levonorgestrel (n=1117) orally. Allocation was by block randomisation stratified by centre and time from unprotected sexual intercourse to treatment, with allocation concealment by identical opaque boxes labelled with a unique treatment number. Participants were masked to treatment assignment whereas investigators were not. Follow-up was done 5-7 days after expected onset of next menses. The primary endpoint was pregnancy rate in women who received emergency contraception within 72 h of unprotected sexual intercourse, with a non-inferiority margin of 1% point difference between groups (limit of 1.6 for odds ratio). Analysis was done on the efficacy-evaluable population, which excluded women lost to follow-up, those aged over 35 years, women with unknown follow-up pregnancy status, and those who had re-enrolled in the study. Additionally, we undertook a meta-analysis of our trial and an earlier study to assess the efficacy of ulipristal acetate compared with levonorgestrel. This trial is registered with ClinicalTrials.gov, number NCT00551616. FINDINGS: In the efficacy-evaluable population, 1696 women received emergency contraception within 72 h of sexual intercourse (ulipristal acetate, n=844; levonorgestrel, n=852). There were 15 pregnancies in the ulipristal acetate group (1.8%, 95% CI 1.0-3.0) and 22 in the levonorgestrel group (2.6%, 1.7-3.9; odds ratio [OR] 0.68, 95% CI 0.35-1.31). In 203 women who received emergency contraception between 72 h and 120 h after sexual intercourse, there were three pregnancies, all of which were in the levonorgestrel group. The most frequent adverse event was headache (ulipristal acetate, 213 events [19.3%] in 1104 women; levonorgestrel, 211 events [18.9%] in 1117 women). Two serious adverse events were judged possibly related to use of emergency contraception; a case of dizziness in the ulipristal acetate group and a molar pregnancy in the levonorgestrel group. In the meta-analysis (0-72 h), there were 22 (1.4%) pregnancies in 1617 women in the ulipristal acetate group and 35 (2.2%) in 1625 women in the levonorgestrel group (OR 0.58, 0.33-0.99; p=0.046). INTERPRETATION: Ulipristal acetate provides women and health-care providers with an effective alternative for emergency contraception that can be used up to 5 days after unprotected sexual intercourse. FUNDING: HRA Pharma.


Subject(s)
Contraceptives, Oral, Synthetic/therapeutic use , Contraceptives, Postcoital, Hormonal/therapeutic use , Levonorgestrel/therapeutic use , Norpregnadienes/therapeutic use , Adult , Coitus , Contraception, Postcoital/methods , Contraceptives, Oral, Synthetic/administration & dosage , Contraceptives, Oral, Synthetic/adverse effects , Contraceptives, Oral, Synthetic/pharmacology , Contraceptives, Postcoital, Hormonal/administration & dosage , Contraceptives, Postcoital, Hormonal/adverse effects , Contraceptives, Postcoital, Hormonal/pharmacology , Female , Follow-Up Studies , Humans , Levonorgestrel/administration & dosage , Levonorgestrel/adverse effects , Levonorgestrel/pharmacology , Menstrual Cycle/drug effects , Meta-Analysis as Topic , Middle Aged , Norpregnadienes/administration & dosage , Norpregnadienes/adverse effects , Norpregnadienes/pharmacology , Ovulation/drug effects , Pregnancy , Treatment Outcome
18.
J Speech Lang Hear Res ; 51(6): 1620-9, 2008 Dec.
Article in English | MEDLINE | ID: mdl-18664689

ABSTRACT

PURPOSE: Past research has established parameters for the 2f1-f2 distortion product otoacoustic emissions (DPOAEs) that enhance response levels (e.g., L1 - L2 = 10 dB; f2/f1 = 1.22; L1, L2 = 65, 55 dB SPL). These same parameters do not optimize 2f2-f1 DPOAEs. Therefore, this study was conducted to evaluate more completely those parameters that produce the most robust 2f2-f1 output. METHOD: Input-output functions of the 2f2-f1 component were obtained from 20 normal-hearing adults (with f2 = 2000 Hz and 4000 Hz). Frequency ratios, level differences, and overall sound levels were manipulated with parameter combinations chosen to expand on information established in previous studies. The DPOAE signal-to-noise ratio (SNR), response presence, and output levels were measured. RESULTS: In general, mean SNRs and 2f2-f1 levels were greater, and DPOAEs were present more often for 2000 than for 4000 Hz across all parameter combinations. No single parameter combination resulted in pronounced maxima for 2f2-f1, which is consistent with past studies but is in sharp contrast to results for the more familiar 2f1-f2. CONCLUSIONS: Overall, the results suggest that to maximize the 2f2-f1 level, lower test frequencies, low frequency ratio, essentially equal levels of primary tones, and moderate stimulus levels are best, and such parameters might be important for applying DPOAE measurement to assessment of normal and impaired auditory function.


Subject(s)
Acoustic Stimulation , Cochlea/physiology , Otoacoustic Emissions, Spontaneous/physiology , Adult , Female , Humans , Male
19.
Contraception ; 77(3): 155-61, 2008 Mar.
Article in English | MEDLINE | ID: mdl-18279684

ABSTRACT

BACKGROUND: We hypothesized that complications for second trimester terminations are higher in a low-volume residency training program than in a high-volume private practice. STUDY DESIGN: Complications and cost were compared between three groups undergoing second trimester terminations: patients undergoing dilation and evacuation (D&E) at a university hospital (Hospital D&E, n=83) or medical pregnancy termination at a university hospital (Hospital Induction, n=89) and D&E at a private outpatient facility (Clinic D&E, n=253). RESULTS: Major complications occurred in 11% of the Hospital D&E, 10% of the Hospital Induction, and 1% of the Clinic D&E patients (p=.0019). Complication rates remained statistically significant when a logistic regression model was applied to the data. The mean total charge for the three respective groups was US$4625, US$5029 and US$1105 (p<.001). CONCLUSION: Second trimester terminations of pregnancy by D&E in well-selected patients in a dedicated outpatient facility can be safer and less expensive than hospital-based D&E or induction of labor.


Subject(s)
Abortion, Induced/adverse effects , Ambulatory Care Facilities/statistics & numerical data , Hospitals, University/statistics & numerical data , Outcome Assessment, Health Care , Pregnancy Trimester, Second , Abortifacient Agents/therapeutic use , Abortion, Induced/economics , Abortion, Induced/methods , Adolescent , Adult , Ambulatory Care Facilities/economics , Cohort Studies , Costs and Cost Analysis , Dilatation and Curettage/adverse effects , Dinoprostone/therapeutic use , Female , Health Care Costs/statistics & numerical data , Hospitals, University/economics , Humans , Misoprostol/therapeutic use , Postoperative Complications/epidemiology , Pregnancy , Retrospective Studies
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