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STUDY OBJECTIVES: To measure the incidence of intraoperative hypotension (IOH) during surgery in ambulatory surgery centers (ASCs) and describe associated characteristics of patients and procedures. DESIGN: Retrospective analysis. SETTING: 20 ASCs. PATIENTS: 16,750 patients having non-emergent, non-cardiac surgery; ASA physical status 2 through 4. INTERVENTIONS: None. MEASUREMENTS: We assessed incidence of IOH using the definition from the Centers for Medicare & Medicaid Services (CMS) Merit-based Incentive Payment System (MIPS)-mean arterial pressure (MAP) < 65 mmHg for at least 15 cumulative minutes-and three secondary definitions: minutes of MAP <65 mmHg, area under MAP of 65 mmHg, and time-weighted average MAP <65 mmHg. MAIN RESULTS: 30.9% of ASC cases had a MAP <65 mmHg for at least 15 min. The incidence of IOH varied significantly, and was higher among younger adults (age 18-39; 36.2%), females (35.2%), and patients with ASA physical status 2 (32.8%). IOH increased with increasing surgery length, even when time-weighted, and was higher among low complexity (30.6%) than moderate complexity (28.8%) procedures, and highest among high complexity procedures (44.1%). CONCLUSIONS: There was substantial occurrence of IOH in ASCs, similar to that described in academic hospital settings in previous literature. We hypothesize that this may reflect clinician preference not to intervene in perceived healthy patients or assumptions about ability to tolerate lower blood pressures on behalf of these patients. Future research will determine whether IOH in ACSs is associated with adverse outcomes to the same extent as described in more complex hospital-based surgeries.
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Procedimentos Cirúrgicos Ambulatórios , Hipotensão , Adulto , Feminino , Humanos , Idoso , Estados Unidos , Adolescente , Adulto Jovem , Estudos Retrospectivos , Estudos de Coortes , Procedimentos Cirúrgicos Ambulatórios/efeitos adversos , Complicações Intraoperatórias/epidemiologia , Complicações Intraoperatórias/etiologia , Medicare , Hipotensão/etiologia , Hipotensão/complicaçõesRESUMO
BACKGROUND: Intraoperative hypotension (IOH) is well-described in the academic setting but not in community practice. IOH is associated with risk of postoperative morbidity and mortality. This is the first report of IOH in the community setting using the IOH measure definition from the Centers for Medicare and Medicaid Services Merit-based Incentive Payment System program. OBJECTIVES: To describe the incidence of IOH in the community setting; assess variation in IOH by patient-, procedure-, and facility-level characteristics; and describe variation in risk-adjusted IOH across clinicians. METHODS: Design Cross-sectional descriptive analysis of retrospective data from anesthesia records in 2020 and 2021. Setting Forty-five facilities affiliated with two large anesthesia providers in the USA. Participants Patients aged 18 years or older having non-emergent, non-cardiac surgery under general, neuraxial, or regional anesthesia. Cases were excluded based on criteria for the IOH measure: baseline mean arterial pressure (MAP) below 65 mmHg prior to anesthesia induction; American Society of Anesthesiologists (ASA) physical status classification of I, V, or VI; monitored anesthesia care only; deliberate induced hypotension; obstetric non-operative procedures; liver or lung transplant; cataract surgery; non-invasive gastrointestinal cases. Main outcomes IOH, using four definitions. Primary definition: binary assessment of whether the case had MAP < 65 mmHg for 15 min or more. Secondary definitions: total number of minutes of MAP < 65 mmHg, total area under MAP of 65 mmHg, time-weighted average MAP < 65 mmHg. RESULTS: Among 127,095 non-emergent, non-cardiac cases in community anesthesia settings, 29% had MAP < 65 mmHg for at least 15 min cumulatively, with an overall mean of 12.4 min < 65 mmHg. IOH was slightly more common in patients who were younger, female, and ASA II (versus III or IV); in procedures that were longer and had higher anesthesia base units; and in ambulatory surgery centers. Incidence of IOH varied widely across individual clinicians in both unadjusted and risk-adjusted analyses. CONCLUSION: Intraoperative hypotension is common in community anesthesia practice, including among patients and settings typically considered "low risk." Variation in incidence across clinicians remains after risk-adjustment, suggesting that IOH is a modifiable risk worth pursuing in quality improvement initiatives.
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INTRODUCTION: Reliable and valid measures are needed to assess the patient-centeredness of clinical care among Latino populations. METHODS: We translated the Consultation and Relational Empathy (CARE) measure from English to Spanish and assessed its psychometric properties using data from 349 Latino parents/guardians visiting a pediatric clinic. Using confirmatory factor analysis, we examined the psychometric properties of the Spanish CARE measure. RESULTS: Internal reliability of the Spanish CARE measure was high (Omega coefficient = 0.95). Similar to the English-language CARE measure, factor analysis of the Spanish CARE measure yielded a single domain of patient-centeredness with high item loadings (factor loadings range from 0.79 to 0.96). CONCLUSION: This preliminary analysis supports the reliability and validity of the Spanish version of the CARE measure among Latinos in pediatric care settings. With further testing, the Spanish CARE measure may be a useful tool for tracking and improving the health care delivered to Latino populations.
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Empatia , Idioma , Criança , Hispânico ou Latino , Humanos , Assistência Centrada no Paciente , Psicometria , Encaminhamento e Consulta , Reprodutibilidade dos Testes , Inquéritos e QuestionáriosRESUMO
BACKGROUND: Intraoperative hypotension is common and associated with organ injury and death, although randomized data showing a causal relationship remain sparse. A risk-adjusted measure of intraoperative hypotension may therefore contribute to quality improvement efforts. METHODS: The measure we developed defines hypotension as a mean arterial pressure <65 mm Hg sustained for at least 15 cumulative minutes. Comparisons are based on whether clinicians have more or fewer cases of hypotension than expected over 12 months, given their patient mix. The measure was developed and evaluated with data from 225,389 surgeries in 5 hospitals. We assessed discrimination and calibration of the risk adjustment model, then calculated the distribution of clinician-level measure scores, and finally estimated the signal-to-noise reliability and predictive validity of the measure. RESULTS: The risk adjustment model showed acceptable calibration and discrimination (area under the curve was 0.72 and 0.73 in different validation samples). Clinician-level, risk-adjusted scores varied widely, and 36% of clinicians had significantly more cases of intraoperative hypotension than predicted. Clinician-level score distributions differed across hospitals, indicating substantial hospital-level variation. The mean signal-to-noise reliability estimate was 0.87 among all clinicians and 0.94 among clinicians with >30 cases during the 12-month measurement period. Kidney injury and in-hospital mortality were most common in patients whose anesthesia providers had worse scores. However, a sensitivity analysis in 1 hospital showed that score distributions differed markedly between anesthesiology fellows and attending anesthesiologists or certified registered nurse anesthetists; score distributions also varied as a function of the fraction of cases that were inpatients. CONCLUSIONS: Intraoperative hypotension was common and was associated with acute kidney injury and in-hospital mortality. There were substantial variations in clinician-level scores, and the measure score distribution suggests that there may be opportunity to reduce hypotension which may improve patient safety and outcomes. However, sensitivity analyses suggest that some portion of the variation results from limitations of risk adjustment. Future versions of the measure should risk adjust for important patient and procedural factors including comorbidities and surgical complexity, although this will require more consistent structured data capture in anesthesia information management systems. Including structured data on additional risk factors may improve hypotension risk prediction which is integral to the measure's validity.
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Pressão Arterial , Técnicas de Apoio para a Decisão , Procedimentos Cirúrgicos Eletivos/efeitos adversos , Hipotensão/etiologia , Injúria Renal Aguda/etiologia , Adolescente , Adulto , Idoso , Procedimentos Cirúrgicos Eletivos/mortalidade , Feminino , Mortalidade Hospitalar , Humanos , Hipotensão/diagnóstico , Hipotensão/mortalidade , Hipotensão/fisiopatologia , Período Intraoperatório , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Indicadores de Qualidade em Assistência à Saúde , Reprodutibilidade dos Testes , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Estados Unidos , Adulto JovemRESUMO
Objective: To pilot test the effectiveness, feasibility, and acceptability of instituting a 15-pill quantity default in the electronic health record for new Schedule II opioid prescriptions. Design: A mixed-methods pilot study in two health systems, including pre-post analysis of prescribed opioid quantity and focus groups or interviews with prescribers and health system administrators. Methods: We implemented a 15-pill electronic health record default for new Schedule II opioids and assessed opioid quantity before and after implementation using electronic health record data on 6,390 opioid prescriptions from 448 prescribers. We then analyzed themes from focus groups and interviews with four staff members and six prescribers. Results: The proportion of opioid prescriptions for 15 pills increased at both sites after adding an electronic health record default, with one reaching statistical significance (from 4.1% to 7.2% at CHC, P = 0.280, and 15.9% to 37.2% at WVU, P < 0.001). The proportion of 15-pill prescriptions increased among high-prescribing departments and among most high- and low-frequency prescribers, except for low-frequency prescribers at CHC. Sites reported limited challenges in instituting the default, although ease of implementation varied by electronic health record vendor. Most prescribers were not aware of the default change and stated that they made prescribing decisions based on patient clinical characteristics rather than defaults. Conclusions: This pilot provides initial evidence that changing default settings can increase the number of prescriptions at the default level. This low-cost and relatively simple intervention could have an impact on opioid overprescribing. However, default settings should be selected carefully to avoid unintended consequences.
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Analgésicos Opioides/uso terapêutico , Prescrições de Medicamentos/estatística & dados numéricos , Registros Eletrônicos de Saúde , Prescrição Inadequada/estatística & dados numéricos , Uso Indevido de Medicamentos sob Prescrição/estatística & dados numéricos , Substâncias Controladas , Humanos , Projetos Piloto , Padrões de Prática Médica/estatística & dados numéricosRESUMO
INTRODUCTION: This study evaluates the impact of practice participation in a pediatric patient-centered medical home learning collaborative on preventable emergency department (ED) visits among children in MassHealth (Massachusetts Medicaid/Children's Health Insurance Program). METHODS: Claims and enrollment data were extracted for child MassHealth members (aged 3-18) comprising 2 groups: members enrolled in a group of 13 child-serving practices that participated in an intensive, 29-month long patient-centered medical home learning collaborative (intervention group), and members enrolled in a group of 12 comparison practices with roughly similar panel size, type, and geographic location (comparison group). Preventable ED visits were identified using a modified version of the New York University ED algorithm. Two analyses were then conducted: (1) a repeat cross-sectional analysis among children enrolled in intervention or comparison group practices during baseline (first half of 2011) and follow-up (second half of 2013) periods; and (2) a longitudinal analysis among a subset of children enrolled for the full study period (2011-2013). Both analyses tested whether the effect of the intervention differed for children with versus without chronic conditions (effect modification). RESULTS: Preventable ED visits declined from baseline to follow-up among children in both intervention and comparison practices. In the cross-sectional analysis, the decrease was the same in both practice groups, and for children with versus without chronic conditions. The longitudinal analysis shows a statistically significantly greater decrease among children with chronic conditions enrolled in the intervention practices (P = 0.02). CONCLUSION: Children with chronic conditions might receive the greatest benefit from receiving care in a medical home setting.
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Objectives The objective of this study was to describe factors that influence the ability of state Medicaid agencies to report the Centers for Medicare & Medicaid Services' (CMS) core set of children's health care quality measures (Child Core Set). Methods We conducted a multiple-case study of four high-performing states participating in the Children's Health Insurance Program Reauthorization Act (CHIPRA) Quality Demonstration Grant Program: Illinois, Maine, Pennsylvania, and Oregon. Cases were purposively selected for their diverse measurement approaches and used data from 2010 to 2015, including 154 interviews, semiannual grant progress reports, and annual public reports on Child Core Set measures. We followed Yin's multiple-case study methodology to describe how and why each state increased the number of measures reported to CMS. Results All four states increased the number of Child Core Set measures reported to CMS during the grant period. Each took a different approach to reporting, depending on the available technical, organizational, and behavioral inputs in the state. Reporting capacity was influenced by a state's Medicaid data availability, ability to link to other state data systems, past experience with quality measurement, staff time and technical expertise, and demand for the measures. These factors were enhanced by CHIPRA Quality Demonstration grant funding and other federal capacity building activities, as hypothesized in our conceptual framework. These and other states have made progress reporting the Child Core Set since 2010. Conclusion With financial support and investment in state data systems and organizational factors, states can overcome challenges to reporting most of the Child Core Set measures.
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Serviços de Saúde da Criança/normas , Qualidade da Assistência à Saúde/ética , Governo Estadual , Criança , Serviços de Saúde da Criança/organização & administração , Pré-Escolar , Financiamento da Assistência à Saúde , Humanos , Illinois , Lactente , Seguro Saúde/legislação & jurisprudência , Seguro Saúde/tendências , Maine , Medicaid/legislação & jurisprudência , Medicaid/organização & administração , Oregon , Pennsylvania , Qualidade da Assistência à Saúde/legislação & jurisprudência , Estados UnidosRESUMO
As primary care models increasingly include nonphysician team members, more attention should be paid to patient- and family-centered care (PFCC) among medical assistants (MAs). The aims of this article are to describe parent perceptions of PFCC by MAs and assess associations between MA PFCC and other perceptions of their care experience. To assess PFCC, we administered the CARE (Consultation and Relational Empathy) measure to the parent/guardian of 360 children following a primary care visit. Perceptions of PFCC by MAs were significantly associated with 6 of 7 other measures of patient experience, including PFCC by the physician, treatment by the receptionist, and satisfaction with wait time. Each team member can potentially shape perceptions of care in ways that could "spill over" into other parts of the visit.
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Enfermagem Familiar , Assistência Centrada no Paciente , Adolescente , Criança , Pré-Escolar , Feminino , Pesquisas sobre Atenção à Saúde , Humanos , Lactente , Masculino , Modelos Organizacionais , Satisfação do Paciente/estatística & dados numéricos , Atenção Primária à SaúdeRESUMO
BACKGROUND: The patient-centered medical home (PCMH) is widely promoted as a model to improve the quality of primary care and lead to more efficient use of health care services. Few studies have examined the relationship between PCMH implementation at the practice level and health care utilization by children. Existing studies show mixed results. METHODS: Using practice-reported PCMH assessments and Medicaid claims from child-serving practices in 3 states participating in the Children's Health Insurance Program Reauthorization Act of 2009 Quality Demonstration Grant Program, this study estimates the association between medical homeness (tertiles) and receipt of well-child care and nonurgent, preventable, or avoidable emergency department (ED) use. Multilevel logistic regression models are estimated on data from 32 practices in Illinois (IL) completing the National Committee for Quality Assurance's (NCQA) medical home self-assessment and 32 practices in North Carolina (NC) and South Carolina (SC) completing the Medical Home Index (MHI) or Medical Home Index-Revised Short Form (MHI-RSF). RESULTS: Medical homeness was not associated with receipt of age-appropriate well-child visits in either sample. Associations between nonurgent, preventable, or avoidable ED visits and medical homeness varied. No association was seen among practices in NC and SC that completed the MHI/MHI-RSF. Children in practices in IL with the highest tertile NCQA self-assessment scores were less likely to have a nonurgent, preventable, or avoidable ED visit than children in practices with low (odds ratio 0.65; 95% confidence interval 0.47-0.92; P < .05) and marginally less likely to have such a visit compared with children in practices with medium tertile scores (odds ratio 0.72, 95% confidence interval 0.52-1.01; P = .06). CONCLUSIONS: Higher levels of medical homeness may be associated with lower nonurgent, preventable, or avoidable ED use by publicly insured children. Robust longitudinal studies using multiple measures of medical homeness are needed to confirm this observation.
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Children's Health Insurance Program , Serviço Hospitalar de Emergência/estatística & dados numéricos , Medicaid , Aceitação pelo Paciente de Cuidados de Saúde , Assistência Centrada no Paciente , Atenção Primária à Saúde/estatística & dados numéricos , Adolescente , Criança , Serviços de Saúde da Criança/estatística & dados numéricos , Pré-Escolar , Feminino , Humanos , Lactente , Recém-Nascido , Modelos Logísticos , Masculino , Análise Multinível , North Carolina , South Carolina , Estados UnidosRESUMO
UNLABELLED: Objectives To evaluate the psychometric properties of the Microbicide Use Self-Efficacy (MUSE) instrument and to examine correlates of self-efficacy to use vaginal microbicides among a sample of racially and ethnically diverse women living in the north-eastern United States. METHODS: Exploratory and confirmatory factor analytic methods were used to explore and determine the dimensionality and psychometric properties of the MUSE instrument. Construct validity was assessed by examining the relationships of the MUSE instrument to key sexual behaviour, partner communication, relationship and psychosocial variables. RESULTS: Two dimensions of self-efficacy to use microbicides were psychometrically validated and identified as 'Adherence and Access' and 'Situational Challenges.' The two four-item subscales measuring Adherence and Access and Situational Challenges had reliability coefficients of 0.78 and 0.85, respectively. Correlates of the two measures were tested at a Bonferroni-adjusted α level of P=0.001, and 19 of 43 variables analysed were found to significantly relate to Adherence and Access, whereas 16 of 43 variables were significantly related to Situational Challenges. Of the 35 significant relationships, 32 were in the domains of partner communication, partner relationships, and behavioural and psychosocial variables. CONCLUSIONS: The MUSE instrument demonstrated strong internal validity, reliability and initial construct validity. The MUSE instrument can be a useful tool in capturing the multidimensional nature of self-efficacy to use microbicides among diverse populations of women.
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Reprodutibilidade dos Testes , Autoeficácia , Anti-Infecciosos , Feminino , Humanos , Psicometria , Comportamento Sexual , Inquéritos e QuestionáriosRESUMO
In vitro fertilization (IVF) has become a standard treatment for subfertility after it was demonstrated to be of value to humans in 1978. However, the introduction of IVF into mainstream clinical practice has been accompanied by concerns regarding the number of multiple gestations that it can produce, as multiple births present significant medical consequences to mothers and offspring. When considering IVF as a treatment modality, a balance must be set between the chance of having a live birth and the risk of having a multiple birth. As IVF is often a costly decision for patients-financially, medically, and emotionally-there is benefit from estimating a patient's specific chance that IVF could result in a birth as fertility treatment options are contemplated. Historically, a patient's "chance of success" with IVF has been approximated from institution-based statistics, rather than on the basis of any particular clinical parameter (except age). Furthermore, the likelihood of IVF resulting in a twin or triplet outcome must be acknowledged for each patient, given the known increased complications of multiple gestation and consequent increased risk of poor birth outcomes. In this research, we describe a multivariate risk assessment model that incorporates metrics adapted from a national 7.5-year sampling of the Human Fertilisation & Embryology Authority (HFEA) dataset (1991-1998) to predict reproductive outcome (including estimation of multiple birth) after IVF. To our knowledge, http://www.formyodds.com is the first Software-as-a-Service (SaaS) application to predict IVF outcome. The approach also includes a confirmation functionality, where clinicians can agree or disagree with the computer-generated outcome predictions. It is anticipated that the emergence of predictive tools will augment the reproductive endocrinology consultation, improve the medical informed consent process by tailoring the outcome assessment to each patient, and reduce the potential for adverse outcomes with IVF.
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Perinatal depression is a prevalent and detrimental condition. Determining modifiable factors associated with it would identify opportunities for prevention. This paper: 1) identifies depressive symptom trajectories and heterogeneity in those trajectories during pregnancy through the first-year postpartum, and 2) examines the association between unintended pregnancy and depressive symptoms. Depressive symptoms (BDI-II) were collected from low-income Hispanic immigrants (n=215) five times from early pregnancy to 12-months postpartum. The sample was at high-risk for perinatal depression and recruited from two prenatal care settings. Growth mixture modeling (GMM) was used to identify distinct trajectories of depressive symptoms over the perinatal period. Multinomial logistic regression was then conducted to examine the association between unintended pregnancy (reported at baseline) and the depression trajectory patterns. Three distinct trajectory patterns of depressive symptoms were identified: high during pregnancy, but low postpartum ("Pregnancy High": 9.8%); borderline during pregnancy, with a postpartum increase ("Postpartum High": 10.2%); and low throughout pregnancy and postpartum ("Perinatal Low": 80.0%). Unintended pregnancy was not associated with the "Pregnancy High" pattern, but was associated with a marginally significant nearly four fold increase in risk of the "Postpartum High" pattern in depressive symptoms (RRR=3.95, p<0.10). Family planning is a potential strategy for the prevention of postpartum depression. Women who report unintended pregnancies during prenatal care must be educated of their increased risk, even if they do not exhibit antenatal depressive symptoms. Routine depression screening should occur postpartum, and referral to culturally appropriate treatment should follow positive screening results.
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Depressão/psicologia , Emigrantes e Imigrantes/psicologia , Hispânico ou Latino/psicologia , Pobreza , Gravidez não Desejada , Feminino , Humanos , Gravidez , Fatores de RiscoRESUMO
Hispanic women, a large and growing ethnic minority group in the U.S., have an unintended birth rate over twice the national average. However, little is known about unintended birth among Hispanic immigrants. The purpose of this study is to determine the sociodemographic, including immigration-related, correlates of unintended birth in this population. Data were collected as part of a preventive intervention among pregnant Hispanic immigrants at increased risk for depression (n = 215). The correlates of women's self-reported pregnancy intention (intended, mistimed, unwanted) were examined using multinomial logistic regression. Similar to nationally representative findings, unintended birth was more common among younger women, single women and women not cohabiting with their partners, and women with more children. Additionally, women who had immigrated to the U.S. less than 1 year ago had almost a 4 times greater risk of a mistimed birth (RRR = 3.82, P < 0.05) compared to women who immigrated 1-4 years ago. Women with greater social support scores had a reduced chance of mistimed (RRR = 0.98, P < 0.10) and unwanted (RRR = 0.97, P < 0.05) birth. The findings have implications for development of effective and culturally appropriate family planning programs. They suggest that interventions should target young women, women who have achieved their desired family size, and very recent immigrants.
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Transtorno Depressivo Maior/etnologia , Transtorno Depressivo Maior/etiologia , Emigrantes e Imigrantes/psicologia , Pobreza , Gravidez não Planejada/etnologia , Aculturação , Adolescente , Adulto , América Central/etnologia , District of Columbia , Feminino , Humanos , Gravidez , Gravidez não Planejada/psicologia , Medição de Risco , Inquéritos e Questionários , Adulto JovemRESUMO
The role of maternal stress during pregnancy remains a focus of academic and clinical inquiry, yet there are few instruments available that measure pregnancy-specific contributors to maternal psychological state. This report examines the psychometric properties of an abbreviated version of the Pregnancy Experience Scale (PES) designed to evaluate maternal appraisal of positive and negative stressors during pregnancy. The PES-Brief consists of the top 10 items endorsed as pregnancy hassles and 10 pregnancy uplifts from the original scale. The PES-Brief was administered to 112 women with low risk, singleton pregnancies five times between 24 and 38 weeks gestation. Scoring includes frequency and intensity measures for hassles and uplifts, as well as composite measures for the relation between the two. Internal reliability, test-retest reliability and convergent validity were comparable with the original version. The PES-Brief provides an economical source of information on stress appraisal and emotional valence towards pregnancy.
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Emoções , Gravidez/psicologia , Testes Psicológicos , Adaptação Psicológica , Adulto , Feminino , Humanos , Reprodutibilidade dos Testes , Estresse Psicológico , Inquéritos e Questionários , Estados UnidosRESUMO
OBJECTIVE: To investigate women's willingness to use vaginal microbicides to reduce/prevent HIV infection, using measures grounded in the individual, behavioral, and social contexts of sex. DESIGN: A cross-sectional study that enrolled a sample (N = 531) of 18-55 year old Latina, African-American, and White women in the U.S. between October, 2004, and July, 2005. MAIN OUTCOME MEASURES: Willingness to use microbicides and individual- and context-related variables (e.g., demographics, relationship status). RESULTS: Exploratory and confirmatory factor analyses supported a one-dimensional, 8-item scale, with high internal consistency (alpha = .91). Subgroup analyses within the Latina (n = 166), African- American (n = 193), and White sub-samples (n = 172) also supported a unidimensional scale with strong internal validity and high reliability. Race/ethnicity as a contextual factor, a woman's history of using prevention products, and the nature of the sexual partnership were predictive of willingness to use microbicides (R = .41). That is, women with greater frequencies of condom use, a history of spermicide use, and non-main sexual partners had higher predicted Willingness to Use Microbicides scale scores, while White women had lower predicted scores. CONCLUSION: The Willingness to Use Microbicides scale serves as the first psychometrically validated measure of factors related to microbicide acceptability. Developing and implementing psychometrically validated and contextualized microbicide acceptability measures, in an effort to understand microbicide users and circumstances of use, is crucial to both clinical trials and future intervention studies.
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Anti-Infecciosos/administração & dosagem , Infecções por HIV/prevenção & controle , Aceitação pelo Paciente de Cuidados de Saúde/etnologia , Inquéritos e Questionários , Adolescente , Adulto , Negro ou Afro-Americano/estatística & dados numéricos , Estudos Transversais , Análise Fatorial , Feminino , Hispânico ou Latino/estatística & dados numéricos , Humanos , Pessoa de Meia-Idade , Análise Multivariada , Aceitação pelo Paciente de Cuidados de Saúde/psicologia , Análise de Regressão , Reprodutibilidade dos Testes , Parceiros Sexuais , Estados Unidos , Cremes, Espumas e Géis Vaginais , População Branca/estatística & dados numéricosRESUMO
In the context of a measurement development study designed to contextualize microbicide acceptability, a sample that represented a range of at-risk women and maintained the statistical power needed for validity analyses was required. A non-proportional quota sampling strategy focused on race/ethnicity and number of sexual partners was utilized. This strategy resulted in enrollment of approximately equal proportions of Latina (31%), Black (36%), and White (32%) women, and an approximately 1:2 ratio of single-partnered (29%) and multi-partnered (71%) women. About 17% of women screened were ineligible based on eligibility criteria; an additional 16% were ineligible based on quota closures. Most participants were recruited through word of mouth (39%), community-based organizations (19%), or media sources (19%). Women recruited through word of mouth had the highest screen-to-interview completion percentage (67%). Non-proportional quota sampling is a feasible option for ensuring adequate representation of sample characteristics in microbicide research, but this goal should be weighed against cost and staff burden.
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Anti-Infecciosos/administração & dosagem , Seleção de Pacientes , Tamanho da Amostra , Infecções Sexualmente Transmissíveis/prevenção & controle , Saúde da Mulher , Adolescente , Adulto , Feminino , Infecções por HIV/prevenção & controle , Pesquisas sobre Atenção à Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Estudos de Amostragem , Comportamento Sexual , Parceiros SexuaisRESUMO
BACKGROUND: Along with efficacy, a microbicide's acceptability will be integral to its impact on the pandemic. Understanding Product Characteristics that users find most acceptable and determining who will use which type of product are key to optimizing use effectiveness. OBJECTIVES: To evaluate psychometrically the Important Microbicide Characteristics (IMC) instrument and examine its relationship to willingness to use microbicides. RESULTS: Exploratory and confirmatory factor analyses revealed 2 IMC subscales (Cronbach's coefficient alpha: Product Characteristics subscale (alpha = 0.84) and Protective Properties subscale (alpha = 0.89)). Significant differences on Product Characteristics subscale scores were found for history of douching (P = 0.002) and employment status (P = 0.001). Whether a woman used a method to prevent pregnancy or sexually transmitted disease (STD) in the last 3 months (P < 0.001) and whether she used a condom during the last vaginal sex episode (P < 0.001) were significantly related to her rating of the importance of microbicides being contraceptive. Product Characteristics (r = 0.21) and Protective Properties (r = 0.27) subscale scores and whether a microbicide had contraceptive properties (r = 0.24) were all significantly associated (P < 0.001) with willingness to use microbicides. CONCLUSIONS: Formulation and use characteristics and product function(s) affect willingness to use microbicides and should continue to be addressed in product development. The IMC instrument serves as a template for future studies of candidate microbicides.