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1.
Br J Haematol ; 204(2): 649-657, 2024 02.
Artigo em Inglês | MEDLINE | ID: mdl-37779237

RESUMO

Health-related quality of life (HRQoL) is an important outcome for patients with sickle cell disease (SCD). It is often poor compared with other chronic medical conditions or measured as a multidomain disease-specific construct. We previously reported outcomes in the Start Healing in Patients with Hydroxyurea (SHIP-HU) randomized controlled trial in adolescents and adults with SCD at six clinical sites. Besides the primary outcomes, we also measured HRQoL as a secondary outcome. Patients in the intervention arm were each assigned community health workers (CHWs) who provided case management services. CHW services were independent of medical management, and medical managers were blinded to the study arm. Patients in the control arm received only standard of care. We hypothesized that having a CHW would improve HRQoL in patients enrolled in SHIP-HU. We did not find significant differences between domains of HRQoL in the two study arms. Possible explanations include selection bias of enrolled versus unenrolled patients, selection bias of sites, medical providers and medical management, enforced blinding, and a lack of cooperation between medical managers and CHWs. The importance of CHWs and HRQoL is nonetheless recognized based on the literature. Future interventions on HRQoL in SCD should consider alternative study designs and multimodal interventions.


Assuntos
Anemia Falciforme , Hidroxiureia , Adolescente , Humanos , Adulto Jovem , Anemia Falciforme/complicações , Antidrepanocíticos/uso terapêutico , Agentes Comunitários de Saúde , Hidroxiureia/uso terapêutico , Qualidade de Vida
2.
Br J Haematol ; 196(1): 193-203, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-34786695

RESUMO

Hydroxyurea (hydroxycarbamide) (HU) for sickle cell anaemia (SCA) is underutilised. Case management is an evidence-based health management strategy and in this regard patient navigators (PNs) may provide case management for SCA. We hypothesised that HU-eligible patients exposed to PNs would have improved indicators of starting HU and HU adherence. We randomised 224 HU-eligible SCA adults into the Start Healing in Patients with Hydroxyurea (SHIP-HU) Trial. All patients received care from trained physicians using standardised HU prescribing protocols. Patients in the Experimental arm received case management and education from PNs through multiple contacts. All other patients were regarded as the Control arm and received specialty care alone. Study physicians were blinded to the study arms and did not interact with PNs. At baseline, 6 and 12 months we assessed and compared laboratory parameters and HU adherence indicators. Experimental patients had higher 6-month mean fetal haemoglobin (HbF) levels than controls. But at 12 months, mean HbF was similar, as were white blood cell count, absolute neutrophil count, total haemoglobin, platelet count and mean corpuscular volume. At 12 months there were fewer experimental patients missing HU doses than controls (mean 1·8 vs. 4·5, P = 0·0098), and more recent HU prescriptions filled than for controls (mean 53·8 vs. 92 days, median 27·5 vs. 62 days, P = 0·0082). Mean HU doses were largely similar. We detected behavioural improvements in HU adherence but no haematological improvements by adding PNs to specialty care.


Assuntos
Anemia Falciforme/epidemiologia , Agentes Comunitários de Saúde , Adesão à Medicação , Adulto , Anemia Falciforme/sangue , Anemia Falciforme/diagnóstico , Anemia Falciforme/terapia , Índices de Eritrócitos , Feminino , Humanos , Hidroxiureia/administração & dosagem , Hidroxiureia/efeitos adversos , Hidroxiureia/uso terapêutico , Análise de Intenção de Tratamento , Masculino , Pessoa de Meia-Idade , Assistência ao Paciente , Melhoria de Qualidade , Qualidade de Vida , Resultado do Tratamento , Adulto Jovem
3.
Eur J Haematol ; 109(3): 215-225, 2022 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-35585659

RESUMO

Disease-specific stress can partly explain Sickle Cell Disease (SCD) healthcare utilization. We developed and validated two measures of adult SCD-specific stress for research and clinical care. A large cohort of adults with SCD completed both the 3-item Likert-scale adapted from a previous disease stress measure and a 10-item Likert-scale questionnaire drafted specifically to measure SCD stress. They concurrently completed a psychosocial and health-related quality of life scale battery, then subsequently daily pain diaries. Diaires measured: daily intensity, distress and interference of pain; self-defined vaso-occlusive crises (VOC), opioid use, and types of healthcare utilization for up to 24 weeks. Analyses tested Cronbach's alpha, correlation of the three-item and 10-item stress scales with the concurrent battery, with percentages of pain days, VOC days, opioid use days, and healthcare utilization days, and correlation of baseline stress and 6-month stress for the 10-item scale. Cronbach's alpha was high for both the 3-item (0.73) and 10-item (0.83) SCD stress scales, test-retest correlation of 0.55, expected correlation with the concurrent battery, and correlation with diary-measured healthcare utilization over 6 months. The correlations with the 3-item scale were stronger, but only statistically significant for depression-anxiety. The correlation between the two stress scales was 0.59. Both the 3-item and the 10-item stress scales exhibited good face, construct, concurrent, and predictive validity as well as moderate test-retest reliability. Further scale validation should determine population norms and response to interventions.


Assuntos
Anemia Falciforme , Compostos Orgânicos Voláteis , Adulto , Analgésicos Opioides/uso terapêutico , Anemia Falciforme/complicações , Anemia Falciforme/diagnóstico , Anemia Falciforme/terapia , Humanos , Dor/diagnóstico , Dor/etiologia , Psicometria , Qualidade de Vida , Reprodutibilidade dos Testes , Inquéritos e Questionários
4.
Pediatr Blood Cancer ; 69(12): e29948, 2022 12.
Artigo em Inglês | MEDLINE | ID: mdl-36151945

RESUMO

A lack of adult sickle cell providers has long been blamed for poor satisfaction and access to specialty care for adults with sickle cell disease (SCD). We were interested in comparing how adolescent and adult patients already in established SCD centers perceived access and quality of care. Hydroxyurea-eligible patients aged 15 years and older were enrolled in the Start Healing in Patients with Hydroxyurea trial, which required them to be affiliated with a SCD specialist. Patients were seen in one of three adult-oriented specialty clinic sites or one of three pediatric-oriented sites. At baseline, patients completed the Adult Sickle Cell Quality of Life Measurement Information System measure as part of a survey battery. Patients treated at adult clinic sites reported being less able to get timely ambulatory appointments (p = .004). They reported emergency department (ED) wait times of >1 h far more often (47.7 vs. 19.3%, p = .0048). They reported less overall satisfaction with care (7.47 vs. 8.77, p < .0001), and less satisfaction with care in the ED (2.88 vs. 3.4, p = .0068. Ambulatory satisfaction was no different between pediatric site versus adult site patients. Poorer systems of care appeared to underlie reported differences, rather than differences in biopsychosocial determinants. Even among specialty-care-affiliated SCD patients, those seen in adult clinics reported worse access to care and lower satisfaction with care than patients seen in pediatric clinics. In addition to increasing the number of adult SCD providers and better preparing pediatric SCD patients to transfer to adult programs, SCD clinical caregivers must also improve aspects of adult care quality to meet reasonable patient expectations of timeliness and interpersonal aspects of care quality.


Assuntos
Anemia Falciforme , Hidroxiureia , Adolescente , Adulto , Humanos , Anemia Falciforme/tratamento farmacológico , Acessibilidade aos Serviços de Saúde , Hidroxiureia/uso terapêutico , Satisfação Pessoal , Qualidade da Assistência à Saúde , Qualidade de Vida
5.
Pharm Stat ; 18(5): 568-582, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31111682

RESUMO

In the medical literature, there has been an increased interest in evaluating association between exposure and outcomes using nonrandomized observational studies. However, because assignments to exposure are not random in observational studies, comparisons of outcomes between exposed and nonexposed subjects must account for the effect of confounders. Propensity score methods have been widely used to control for confounding, when estimating exposure effect. Previous studies have shown that conditioning on the propensity score results in biased estimation of conditional odds ratio and hazard ratio. However, research is lacking on the performance of propensity score methods for covariate adjustment when estimating the area under the ROC curve (AUC). In this paper, AUC is proposed as measure of effect when outcomes are continuous. The AUC is interpreted as the probability that a randomly selected nonexposed subject has a better response than a randomly selected exposed subject. A series of simulations has been conducted to examine the performance of propensity score methods when association between exposure and outcomes is quantified by AUC; this includes determining the optimal choice of variables for the propensity score models. Additionally, the propensity score approach is compared with that of the conventional regression approach to adjust for covariates with the AUC. The choice of the best estimator depends on bias, relative bias, and root mean squared error. Finally, an example looking at the relationship of depression/anxiety and pain intensity in people with sickle cell disease is used to illustrate the estimation of the adjusted AUC using the proposed approaches.


Assuntos
Fatores de Confusão Epidemiológicos , Estudos Observacionais como Assunto/métodos , Projetos de Pesquisa , Anemia Falciforme/fisiopatologia , Anemia Falciforme/psicologia , Ansiedade/epidemiologia , Viés , Simulação por Computador , Depressão/epidemiologia , Humanos , Razão de Chances , Dor/epidemiologia , Pontuação de Propensão , Modelos de Riscos Proporcionais , Curva ROC
6.
Pharm Stat ; 18(5): 533-545, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31069929

RESUMO

Cost and burden of diagnostic testing may be reduced if fewer tests can be applied. Sequential testing involves selecting a sequence of tests, but only administering subsequent tests dependent on results of previous tests. This research provides guidance to choosing between single tests or the believe the positive (BP) and believe the negative (BN) sequential testing strategies, using accuracy (as measured by the Youden Index) as the primary determinant. Approximately 75% of the parameter combinations examined resulted in either BP or BN being recommended based on a higher accuracy at the optimal point. In about half of the scenarios BP was preferred, and the other half, BN, with the choice often a function of the value of the ratio of standard deviations of those without and with disease (b). Large values of b for the first test of the sequence tended to be associated with preference for BN as opposed to BP, while small values of b appear to favor BP. When there was no preference between sequences and/or single tests based on the Youden Index, cost of the sequence was considered. In this case, disease prevalence plays a large role in the selection of strategies, with lower values favoring BN and sometimes higher values favoring BP. The cost threshold for the sequential strategy to be preferred over a single, more accurate test, was often quite high. It appears that while sequential strategies most often increase diagnostic accuracy over a single test, sequential strategies are not always preferred.


Assuntos
Técnicas e Procedimentos Diagnósticos , Testes Diagnósticos de Rotina/métodos , Análise Custo-Benefício , Técnicas e Procedimentos Diagnósticos/economia , Testes Diagnósticos de Rotina/economia , Humanos , Reprodutibilidade dos Testes
7.
Pain Med ; 19(10): 1972-1981, 2018 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-29036363

RESUMO

Background: Pain diary assessment in sickle cell disease (SCD) may be expensive and impose a high respondent burden. Objective: To report whether intermittent assessment could substitute for continuous daily pain assessment in SCD. Design: Prospective cohort study. Setting: Academic and community practices in Virginia. Patients. A total of 125 SCD patients age 16 years or older in the Pain in Sickle Cell Epidemiology Study. Measurements. Using pain measures that summarized all diaries as the gold standard, we tested the statistical equivalence of four alternative strategies that summarized diaries only from the week prior or the month prior to study completion; one week per month; or one day per week (random day). Summary measures included percent pain days, percent crisis days (self-defined), mean pain (0-9 Likert scale) on all days, and mean pain on pain days. Equivalence tests included comparisons of means, regression intercepts, and slopes, as well as measurement of R2. Results: Compared with the gold standard, the one-day-per-week and one-week-per-month strategies yielded statistically equivalent means of six summary pain measures, and the week prior and month prior yielded equivalent means as some of the measures. Regression showed statistically equivalent slopes and intercepts to the gold standard using one-day-per-week and one-week-per-month strategies for percent pain days and percent crisis days, but almost no other equivalence. R2 values ranged from 0.64 to 0.989. Conclusions: It is possible to simulate five- to six-month daily assessment of pain in SCD. Either one-day-per-week or one-week-per-month assessment yields an equivalent mean and fair regression equivalence.


Assuntos
Anemia Falciforme/fisiopatologia , Dor Crônica/fisiopatologia , Medição da Dor/métodos , Adolescente , Adulto , Estudos de Coortes , Feminino , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Estudos Prospectivos , Virginia , Adulto Jovem
8.
BMC Pediatr ; 18(1): 205, 2018 06 26.
Artigo em Inglês | MEDLINE | ID: mdl-29945589

RESUMO

BACKGROUND: Emergency Department (ED) revisits have often been used as an indicator of medical care quality. This study aimed to quantify the frequency of ED revisits within 72 h of discharge and identify its factors among children with chronic diseases. METHODS: We designed a retrospective cohort study of children with at least one chronic disease who were also under 18 years of age and had attended and were discharged from the ED at King Abdullah Specialist Children's Hospital (KASCH-RD), Riyadh, Saudi Arabia between April 19, 2015 and July 29, 2017. The outcome measure was the frequency of ED revisits during a period of 72 h after discharge. RESULTS: The study included 11,057 ED discharges of children with at least one chronic disease. Their revisit rate was 1211 (11%), with 83 (6.9%) having had a second ED revisit within 72 h of ED discharge. According to ICD-10 codes, the most common causes of ED revisits were respiratory, digestive, genitourinary, symptoms, and external causes. Factors of frequent ED revisits within 72 h were young age, institutional health insurance coverage, year of new health information system (2015), external causes, and genitourinary. CONCLUSION: The rate of 72-h ED revisits after discharge of children with chronic diseases treated at KASCH-RD was relatively high, and was associated with young age, institutional health insurance coverage, year of a new health information system implementation, and external causes of ED visit. These study findings amplify the need for intervention to reduce the rate of early ED revisits among children with chronic diseases.


Assuntos
Doença Crônica/terapia , Serviço Hospitalar de Emergência/estatística & dados numéricos , Readmissão do Paciente/estatística & dados numéricos , Adolescente , Fatores Etários , Criança , Pré-Escolar , Feminino , Humanos , Cobertura do Seguro , Seguro Saúde , Masculino , Estudos Retrospectivos , Arábia Saudita , Fatores de Tempo
9.
J Community Psychol ; 46(7): 925-940, 2018 09.
Artigo em Inglês | MEDLINE | ID: mdl-30565740

RESUMO

Universal screening for colorectal cancer (CRC) is recommended for individuals 50-75 years of age, but screening uptake is suboptimal and African Americans have suffered persistent racial disparities in CRC incidence and deaths. We compared a culturally tailored fictional narrative and an engaging expert interview on the ability to increase intentions to be screened for CRC among African American women. In a post-only experiment, women (N = 442) in face-to-face listening groups in African American churches heard audio recordings of either a narrative or an expert interview. Questionnaires were completed immediately afterward and 30 days later. Women who heard narratives reported stronger intentions to be screened with a home stool blood test than women who heard the interview; the effect lasted at least 30 days. Culturally tailored, fictional narratives appear to be an effective persuasive strategy for reducing racial disparities in CRC outcomes.


Assuntos
Negro ou Afro-Americano , Colonoscopia , Neoplasias Colorretais/diagnóstico , Conhecimentos, Atitudes e Prática em Saúde , Promoção da Saúde , Intenção , Idoso , Competência Cultural , Detecção Precoce de Câncer , Feminino , Humanos , Pessoa de Meia-Idade
10.
BMC Emerg Med ; 16(1): 30, 2016 08 20.
Artigo em Inglês | MEDLINE | ID: mdl-27543088

RESUMO

BACKGROUND: Individuals living with sickle cell disease (SCD) have significantly increased emergency department (ED) use compared to the general population. In Saudi Arabia, health care is free for all individuals and therefore has no bearing on increased ED visits. However, little is known about the relationship between quality of life (QoL) and frequency of acute care utilization in this patient population. METHODS: A cross-sectional study was conducted on 366 patients with SCD who attended the outpatient department at King Fahad Hospital, Hofuf, Saudi Arabia. Data were collected through self-administered surveys, which included: demographics, SCD-related ED visits, clinical issues, and QoL levels. We assessed the ED use by asking for the number of SCD-related ED visits within a 6-month period. RESULTS: The self-report survey of ED visits was completed by 308 SCD patients. The median number of SCD-related ED visits within a 6-month time period (IQR) was four (2-7 visits). According to the unadjusted negative binomial model, the rate of SCD-related ED visits increased by (46, 39.3, 40, and 53.5 %) for patients with fever, skin redness with itching, swelling, and blood transfusion, respectively. Poor QoL tends to increase the rate of SCD-related ED visits. Well education and poor general health positively influenced the rate of SCD-related ED visits. Well education tends to increase the rate of SCD-related ED visits by 50.2 %. The rate of SCD-related ED visits decreased by 1.4 % for every point increase in general health. CONCLUSION: Saudi patients with sickle cell disease reported a wide range of SCD-related ED visits. It was estimated that six of 10 SCD patients had at least three ED visits within a 6-month period. Well education and poor general health resulted in an increase in the rate of SCD-related ED visits.


Assuntos
Anemia Falciforme/fisiopatologia , Anemia Falciforme/psicologia , Serviço Hospitalar de Emergência/estatística & dados numéricos , Qualidade de Vida , Adulto , Estudos Transversais , Feminino , Humanos , Masculino , Fatores de Risco , Arábia Saudita , Índice de Gravidade de Doença , Adulto Jovem
11.
Health Qual Life Outcomes ; 13: 183, 2015 Nov 16.
Artigo em Inglês | MEDLINE | ID: mdl-26573908

RESUMO

BACKGROUND: There is a lack of research concerning health-related quality of life (HRQoL) in Saudi patients with sickle cell disease (SCD), particularly among adult populations. The aim of the current study was to describe the characteristics of SCD patients and their impact on their quality of life (QoL). METHODS: Six hundred twenty-nine adult SCD patients who attended King Fahad Hospital in Hofuf and King Fahad Central Hospital in Jazan were included in the analysis. Demographic/clinical data were collected and an Arabic version of the Medical Outcomes 36-Item Short-Form Health Survey (SF-36) questionnaire was used to assess QoL. RESULTS: SCD patients who hold a university degree reported positive impacts on the following domains of SF-36: physical role function, vitality, emotional well being, social function, pain reduction, and general health (P = .002, P = .001, P = .001, P = .003, P = .004, and P = .001, respectively). In general, patients with fever, skin redness, swelling, or history of blood transfusion tended to impair the health status of the SF-36. A multivariate analysis revealed that patients with a university degree tended to report high scores of physical role functions, emotional role function, and vitality. Patients with regular exercise tend to increase vitality, social function, general health, and reduce pain. Unemployment tends to lessen vitality and worsen pain. On average, pain, social function, and physical function scores tended to worsen in patients with swelling or history of blood transfusion. CONCLUSIONS: This study highlighted that poor education, fever, skin redness, and swelling were negatively associated with specific components of SF-36. SCD patients with a history of blood transfusion found their QoL poorer, whereas regular exercise tended to improve QoL.


Assuntos
Anemia Falciforme/psicologia , Atitude Frente a Saúde , Nível de Saúde , Psicometria/instrumentação , Qualidade de Vida/psicologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Reprodutibilidade dos Testes , Arábia Saudita , Fatores Socioeconômicos , Inquéritos e Questionários , Adulto Jovem
12.
J Head Trauma Rehabil ; 30(4): 231-40, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-25931183

RESUMO

BACKGROUND: If and how much dural penetration influences long-term outcome after traumatic brain injury (TBI) is understudied, especially within the civilian population. OBJECTIVES: Using the large TBI Model Systems cohort, this study assessed and compared penetrating TBI (PTBI) and closed TBI with respect to global outcome and late seizures 2 years after injury. METHODS: After performing unadjusted PTBI versus closed TBI comparisons, multivariate regression models were built and analyzed for both outcomes by including the following additional predictors: length of unconsciousness, posttraumatic amnesia duration, hospital length of stay, age, gender, race, marital status, education level, problem substance abuse, and preinjury employment status. RESULTS: The collapsed Glasgow Outcome Scale model (n = 6111) showed significant secondary effects of PTBI with employment status. When employed before injury, individuals with PTBI were 2.62 times more likely (95% confidence interval, 1.92-3.57) to have a lower Glasgow Outcome Scale category. The final model for late seizures (n = 6737) showed a significant main effect for PTBI. Adjusting for other predictors, individuals with PTBI were 2.78 times more likely (95% confidence interval, 1.93-3.99) than those with closed TBI to be rehospitalized for a seizure. CONCLUSION: This study empirically demonstrates that penetrating injury mechanism has important prognostic implications.


Assuntos
Lesões Encefálicas/complicações , Traumatismos Cranianos Fechados/complicações , Traumatismos Cranianos Penetrantes/complicações , Convulsões/epidemiologia , Adulto , Estudos de Coortes , Feminino , Escala de Resultado de Glasgow , Hospitalização , Humanos , Masculino , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde , Fatores Socioeconômicos , Estados Unidos , Adulto Jovem
13.
Pain ; 165(1): 135-143, 2024 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-37578485

RESUMO

ABSTRACT: In a cross-sectional analysis of baseline data from a randomized clinical trial, we studied 198 adolescents and adults aged 15+ with sickle cell disease. Interest was in assessing the relative strengths of the relationship of vaso-occlusive crisis (VOC) pain domains of intensity, frequency, and duration, with health-related quality of life (HRQOL). Variation in psychosocial, physical function, and pain expression domains of HRQOL was partially explained by frequency, intensity, and duration of VOC pain, separately and together, over and above differences in age, sex, genotype, and organ system damage. However, no single domain measure accounted for more than an additional partial R2 of 12.5% alone. Vaso-occlusive crisis pain frequency explained the most variation, when simultaneously considering VOC intensity and duration, except for stiffness , where duration was most predictive. Yet VOC pain intensity, and even VOC duration, also contributed to variability in HRQOL. We recommend that for most purposes, because all 3 VOC pain domains contribute to variability in HRQOL, all 3 domains should be assessed and interventions should be targeted to improve all 3 domains to maximize HRQOL outcomes (Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT02197845 ).


Assuntos
Anemia Falciforme , Compostos Orgânicos Voláteis , Adulto , Humanos , Adolescente , Medição da Dor , Qualidade de Vida , Estudos Transversais , Anemia Falciforme/complicações , Dor/etiologia
14.
Pain ; 2024 May 23.
Artigo em Inglês | MEDLINE | ID: mdl-38787626

RESUMO

ABSTRACT: The US National Pain Strategy recommends identifying individuals with chronic pain (CP) who experience substantial restriction in work, social, or self-care activities as having high-impact chronic pain (HICP). High-impact chronic pain has not been examined among individuals with CP and sickle cell disease (SCD). We analyzed data from 63 individuals with SCD and CP who completed at least 5 months of pain diaries in the Pain in Sickle Cell Epidemiology Study (PiSCES). Forty-eight individuals met the definition for HICP, which was operationalized in this study as reporting pain interference on more than half of diary days. Compared with individuals without HICP, individuals with HICP experienced higher mean daily pain intensity, particularly on days without crises. They also experienced a greater proportion of days with pain, days with healthcare utilization, and days with home opioid use and higher levels of stress. They did not have a statistically significantly higher proportion of days with crises or experience higher mean daily pain intensity on days with crises. Individuals with HICP experienced worse physical functioning and worse physical health compared with those without HICP, controlling for mean pain intensity, age, sex, and education. The results of this study support that HICP is a severely affected subgroup of those with CP in SCD and is associated with greater pain burden and worse health outcomes. The findings from this study should be confirmed prospectively in a contemporary cohort of individuals with SCD.

15.
Stat Med ; 32(16): 2715-27, 2013 Jul 20.
Artigo em Inglês | MEDLINE | ID: mdl-23339070

RESUMO

In noninferiority studies, a limit of indifference is used to express a tolerance in results such that the clinician would regard such results as being acceptable or 'not worse'. We applied this concept to a measure of accuracy, the Receiver Operating Characteristic (ROC) curve, for a sequence of tests. We expressed a limit of indifference for the range of acceptable sensitivity values and examined the associated cost of testing within this range. In doing so, we generated the minimum cost maximum ROC (MCMROC) curve, which reflects the reduced sensitivity and cost of testing. We compared the MCMROC and its associated cost curve between limits of indifference set to 0.999 [a 0.1% reduction in true positive rate (TPR)], 0.95 (a 5% reduction in TPR), and 1 (no reduction in TPR). The limit of indifference tended to have less of an effect on the MCMROC curves than on the associated cost curves that were greatly affected. Cost was reduced at high false positive rates (FPRs) at higher limit of indifference (0.999) and at small FPRs as the limit of indifference decreased (0.95). These patterns were also observed as applied to sequential strategies used to diagnose diabetes in the Pima Indians.


Assuntos
Testes Diagnósticos de Rotina/economia , Curva ROC , Adulto , Simulação por Computador , Diabetes Mellitus/diagnóstico , Testes Diagnósticos de Rotina/normas , Reações Falso-Negativas , Reações Falso-Positivas , Feminino , Teste de Tolerância a Glucose , Humanos , Indígenas Norte-Americanos , Sensibilidade e Especificidade
16.
Clin Trials ; 10(2): 319-31, 2013 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-23539110

RESUMO

BACKGROUND: The hallmark of sickle cell disease (SCD) is pain from a vaso-occlusive crisis. Although ambulatory pain accounts for most days in pain, pain is also the most common cause of hospitalization and is typically treated with parenteral opioids. The evidence base is lacking for most analgesic practice in SCD, particularly for the optimal opioid dosing for patient-controlled analgesia (PCA), in part because of the challenges of the trial design and conduct for this rare disease. PURPOSE: The purpose of this report is to describe our Network's experiences with protocol development, implementation, and analysis, including overall study design, the value of pain assessments rather than 'crisis' resolution as trial endpoints, and alternative statistical analysis strategies. METHODS: The Improving Pain Management and Outcomes with Various Strategies (IMPROVE) PCA trial was a multisite inpatient randomized controlled trial comparing two PCA-dosing strategies in adults and children with SCD and acute pain conducted by the SCD Clinical Research Network. The specified primary endpoint was a 25-mm change in a daily average pain intensity using a Visual Analogue Scale, and a number of related pain intensity and pain interference measures were selected as secondary efficacy outcomes. A time-to-event analysis strategy was planned for the primary endpoint. RESULTS: Of 1116 individuals admitted for pain at 31 participating sites over a 6-month period, 38 were randomized and 4 withdrawn. The trial was closed early due to poor accrual, reflecting a substantial number of challenges encountered during trial implementation. LIMITATIONS: While some of the design issues were unique to SCD or analgesic studies, many of the trial implementation challenges reflected the increasing complexity of conducting clinical trials in the inpatient setting with multiple care providers and evolving electronic medical record systems, particularly in the context of large urban academic medical centers. LESSONS LEARNED: Complicated clinical organization of many sites likely slowed study initiation. More extensive involvement of research staff and site principal investigator in the clinical care operations improved site performance. During the subsequent data analysis, alternative statistical approaches were considered, the results of which should inform future efficacy assessments and increase future trial recruitment success by allowing substantial reductions in target sample size. CONCLUSIONS: A complex randomized analgesic trial was initiated within a multisite disease network seeking to provide an evidence base for clinical care. A number of design considerations were shown to be feasible in this setting, and several pain intensity and pain interference measures were shown to be sensitive to time- and treatment-related improvements. While the premature closure and small sample size precluded definitive conclusions regarding treatment efficacy, this trial furnishes a template for design and implementation considerations that should improve future SCD analgesic trials.


Assuntos
Analgesia Controlada pelo Paciente/métodos , Analgésicos Opioides/administração & dosagem , Anemia Falciforme/complicações , Dor/tratamento farmacológico , Dor/etiologia , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Adolescente , Adulto , Analgesia Controlada pelo Paciente/efeitos adversos , Analgésicos Opioides/uso terapêutico , Criança , Humanos , Estudos Multicêntricos como Assunto , Manejo da Dor/métodos , Medição da Dor , Projetos de Pesquisa
17.
Cancer Causes Control ; 23(8): 1253-64, 2012 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-22674222

RESUMO

BACKGROUND: Reporting of hematologic malignancies is an increasingly important focus for cancer surveillance. As trends in cancer care are shifting to the outpatient setting, hospital-based data collection methods used for cancer surveillance will result in under-reporting of these cancers. This study describes the testing and validation of an automated system for capturing and reporting cancers from community oncology providers. METHODS: The system was evaluated in 5 oncology practices in two states processing claims data for a 4- or 8-month interval. Resulting cancers were matched with the state registries. A random sample of nonmatched cases was reabstracted to measure the accuracy of the claims data for reporting of hematologic malignancies. RESULTS: The overall match rate for the 1,935 hematologic malignancies reported during the study period was 58.2 % (range, 37.4 % for CLL to 71.2 % for Hodgkin's Lymphoma). The overall accuracy rate for billing-reported hematologic malignancies was 95 %. Accuracy among cases that did not match with the cancer registry was 88 %. The estimated number of missed cases for the five participating practices ranged from 0.8 leukemia cases/oncologist/year to 3.4 CLL cases/oncologist/year. The estimated total number of missed cases in the five participating practices was 292 with an interquartile range of 263-323. CONCLUSION: As cancer diagnosis and treatment continue migration into ambulatory physician practice settings unreported hematopoietic cases will become increasingly problematic. Leveraging the standardized electronic billing data for automated reporting of cancer cases from physician practices may be an efficient method to reduce this gap in cancer surveillance reporting.


Assuntos
Coleta de Dados/métodos , Neoplasias Hematológicas/diagnóstico , Assistência Ambulatorial , Monitoramento Epidemiológico , Neoplasias Hematológicas/epidemiologia , Hospitais , Humanos , Oncologia/organização & administração , Monitorização Ambulatorial , North Carolina/epidemiologia , Projetos Piloto , Sistema de Registros , Virginia/epidemiologia
18.
Prev Med ; 54(2): 150-6, 2012 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-22178819

RESUMO

OBJECTIVE: We implemented a theory-based randomized controlled trial (Living Free of Tobacco, Plus (LIFT+) in ten rural middle schools and assessed impact on tobacco use and fruit/vegetable (F/V) intake in 2008-2010. Data on F/V intake at baseline, immediate post intervention, and 1-year follow-up are presented. METHODS: Schools were randomized to intervention or control groups. Goal setting, peer leaders, and class workshops with parent involvement, were intervention features; community partners were supportive. Seventh graders filled out surveys on health behaviors, psycho-social variables, and demographic characteristics. Adjusted models comparing intervention and control conditions were analyzed. RESULTS: Sample (n=1119) was 48.5% female, 50% White, with a mean age of 12.7 years. Mean F/V servings were significantly higher in intervention schools at immediate post (3.19 servings) and at 1-year (3.02 servings) compared to controls (2.90, 2.69 respectively). Knowledge of 5-a-day recommendation was significantly higher in intervention schools at immediate post test (75.0%) versus controls (53.8%) but not at 1-year follow-up. CONCLUSIONS: Intervention schools reported significantly higher mean F/V servings at post intervention and 1-year, and for knowledge of F/V recommendations at immediate post compared to controls. Higher levels of parent and community involvement may further increase F/V intake in future interventions. ClinicalTrials.gov Identifier: NCT01412697.


Assuntos
Frutas , População Rural/estatística & dados numéricos , Instituições Acadêmicas , Estudantes/psicologia , Verduras , Fatores Etários , Criança , Proteção da Criança , Feminino , Objetivos , Promoção da Saúde/métodos , Humanos , Modelos Lineares , Masculino , Motivação , Inquéritos Nutricionais , Estado Nutricional , Estatística como Assunto , Estudantes/estatística & dados numéricos , Virginia
19.
Medsurg Nurs ; 21(5): 281-4, 292, 2012.
Artigo em Inglês | MEDLINE | ID: mdl-23243785

RESUMO

One unit's staff developed and evaluated an intervention to relocate shift-to-shift nursing report to the patient's bedside. Despite challenges related to privacy, distractions, and integration of nursing technicians to the change, bedside shift report reduced shift report times and improved nursing satisfaction.


Assuntos
Registros de Enfermagem , Recursos Humanos de Enfermagem Hospitalar/organização & administração , Avaliação de Processos e Resultados em Cuidados de Saúde , Transferência da Responsabilidade pelo Paciente/organização & administração , Atitude do Pessoal de Saúde , Humanos , Michigan , Projetos Piloto
20.
Front Endocrinol (Lausanne) ; 13: 1037211, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36506048

RESUMO

Objective: We performed a matched cohort study among individuals with and without nonalcoholic fatty liver disease (NAFLD) to determine: 1) the incidence of cancers (extrahepatic and liver) and their spectrum and 2) if NAFLD increases the risk of extrahepatic cancers. Methods: The NAFLD and non-NAFLD (control) cohorts were identified from electronic medical records via International Classification of Diseases (ICD) codes from a single center and followed from 2010 to 2019. Cohorts were matched 1:2 for age, sex, race, body mass index (BMI), and type 2 diabetes. Results: A total of 1,412 subjects were included in the analyses. There were 477 individuals with NAFLD and 935 controls (median age, 52 years; women, 54%; white vs. black: 59% vs. 38%; median BMI, 30.4 kg/m2; type 2 diabetes, 34%). The cancer incidence (per 100,000 person-years) was 535 vs. 1,513 (NAFLD vs. control). Liver cancer incidence (per 100,000 person-years) was 89 in the NAFLD group vs. 0 in the control group, whereas the incidence of malignancy was higher across other types of cancer in the control group vs. in the NAFLD group. Conclusions: The overall extrahepatic cancer risk in NAFLD is not increased above and beyond the risk from background risk factors such as age, race, sex, BMI, and type 2 diabetes.


Assuntos
Carcinoma Hepatocelular , Diabetes Mellitus Tipo 2 , Neoplasias Hepáticas , Hepatopatia Gordurosa não Alcoólica , Feminino , Humanos , Pessoa de Meia-Idade , Hepatopatia Gordurosa não Alcoólica/epidemiologia , Neoplasias Hepáticas/epidemiologia , Neoplasias Hepáticas/etiologia , Diabetes Mellitus Tipo 2/epidemiologia , Estudos de Coortes
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