RESUMEN
Importance: Cervical spondylotic myelopathy is the most common cause of spinal cord dysfunction worldwide. It remains unknown whether a ventral or dorsal surgical approach provides the best results. Objective: To determine whether a ventral surgical approach compared with a dorsal surgical approach for treatment of cervical spondylotic myelopathy improves patient-reported physical functioning at 1 year. Design, Setting, and Participants: Randomized clinical trial of patients aged 45 to 80 years with multilevel cervical spondylotic myelopathy enrolled at 15 large North American hospitals from April 1, 2014, to March 30, 2018; final follow-up was April 15, 2020. Interventions: Patients were randomized to undergo ventral surgery (n = 63) or dorsal surgery (n = 100). Ventral surgery involved anterior cervical disk removal and instrumented fusion. Dorsal surgery involved laminectomy with instrumented fusion or open-door laminoplasty. Type of dorsal surgery (fusion or laminoplasty) was at surgeon's discretion. Main Outcomes and Measures: The primary outcome was 1-year change in the Short Form 36 physical component summary (SF-36 PCS) score (range, 0 [worst] to 100 [best]; minimum clinically important difference = 5). Secondary outcomes included 1-year change in modified Japanese Orthopaedic Association scale score, complications, work status, sagittal vertical axis, health resource utilization, and 1- and 2-year changes in the Neck Disability Index and the EuroQol 5 Dimensions score. Results: Among 163 patients who were randomized (mean age, 62 years; 80 [49%] women), 155 (95%) completed the trial at 1 year (80% at 2 years). All patients had surgery, but 5 patients did not receive their allocated surgery (ventral: n = 1; dorsal: n = 4). One-year SF-36 PCS mean improvement was not significantly different between ventral surgery (5.9 points) and dorsal surgery (6.2 points) (estimated mean difference, 0.3; 95% CI, -2.6 to 3.1; P = .86). Of 7 prespecified secondary outcomes, 6 showed no significant difference. Rates of complications in the ventral and dorsal surgery groups, respectively, were 48% vs 24% (difference, 24%; 95% CI, 8.7%-38.5%; P = .002) and included dysphagia (41% vs 0%), new neurological deficit (2% vs 9%), reoperations (6% vs 4%), and readmissions within 30 days (0% vs 7%). Conclusions and Relevance: Among patients with cervical spondylotic myelopathy undergoing cervical spinal surgery, a ventral surgical approach did not significantly improve patient-reported physical functioning at 1 year compared with outcomes after a dorsal surgical approach. Trial Registration: ClinicalTrials.gov Identifier: NCT02076113.
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Vértebras Cervicales/cirugía , Laminectomía/métodos , Medición de Resultados Informados por el Paciente , Enfermedades de la Médula Espinal/cirugía , Fusión Vertebral/métodos , Espondilosis/cirugía , Anciano , Anciano de 80 o más Años , Vértebras Cervicales/diagnóstico por imagen , Estudios de Seguimiento , Humanos , Imagen por Resonancia Magnética , Persona de Mediana Edad , Complicaciones Posoperatorias , Radiografía , Médula Espinal/diagnóstico por imagen , Resultado del TratamientoRESUMEN
OBJECTIVE: This qualitative study examines surgical consultation as a social process and assesses its alignment with assumptions of the shared decision-making (SDM) model. SUMMARY OF BACKGROUND DATA: SDM stresses the importance of patient preferences and rigorous discussion of therapeutic risks/benefits based on these preferences. However, empirical studies have highlighted discrepancies between SDM and realities of surgical decision making. Qualitative research can inform understanding of the decision-making process and allow for granular assessment of the nature and causes of these discrepancies. METHODS: We observed consultations between 3 general surgeons and 45 patients considering undergoing 1 of 2 preference-sensitive elective operations: (1) hernia repair, or (2) cholecystectomy. These patients and surgeons also participated in semi-structured interviews. RESULTS: By the time of the consultation, patients and surgeons were predisposed toward certain decisions by preceding events occurring elsewhere. During the visit, surgeons had differential ability to arbitrate surgical intervention and construct the severity of patients' conditions. These upstream dynamics frequently displaced the centrality of the risk/benefit-based consent discussion. CONCLUSION: The influence of events preceding consultation suggests that decision-making models should account for broader spatiotemporal spans. Given surgeons' authority to define patients' conditions and control service provision, SDM may be premised on an overestimation of patients' power to alter the course of decision making once in a specialist's office. Considering the subordinate role of the risk/benefit discussion in many surgical decisions, it will be important to study if and how the social process of decision making is altered by SDM-oriented decision aids that foreground this discussion.
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Toma de Decisiones Conjunta , Cirugía General , Participación del Paciente/psicología , Relaciones Médico-Paciente , Derivación y Consulta , Conducta Social , Cirujanos/psicología , Adulto , Anciano , Colecistectomía/métodos , Colecistectomía/psicología , Procedimientos Quirúrgicos Electivos/métodos , Procedimientos Quirúrgicos Electivos/psicología , Femenino , Herniorrafia/métodos , Herniorrafia/psicología , Humanos , Consentimiento Informado/psicología , Entrevistas como Asunto , Masculino , Persona de Mediana Edad , Modelos Teóricos , Prioridad del Paciente , Investigación CualitativaRESUMEN
BACKGROUND: The comparative effectiveness of performing instrumented (rigid pedicle screws affixed to titanium alloy rods) lumbar spinal fusion in addition to decompressive laminectomy in patients with symptomatic lumbar grade I degenerative spondylolisthesis with spinal stenosis is unknown. METHODS: In this randomized, controlled trial, we assigned patients, 50 to 80 years of age, who had stable degenerative spondylolisthesis (degree of spondylolisthesis, 3 to 14 mm) and symptomatic lumbar spinal stenosis to undergo either decompressive laminectomy alone (decompression-alone group) or laminectomy with posterolateral instrumented fusion (fusion group). The primary outcome measure was the change in the physical-component summary score of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36; range, 0 to 100, with higher scores indicating better quality of life) 2 years after surgery. The secondary outcome measure was the score on the Oswestry Disability Index (range, 0 to 100, with higher scores indicating more disability related to back pain). Patients were followed for 4 years. RESULTS: A total of 66 patients (mean age, 67 years; 80% women) underwent randomization. The rate of follow-up was 89% at 1 year, 86% at 2 years, and 68% at 4 years. The fusion group had a greater increase in SF-36 physical-component summary scores at 2 years after surgery than did the decompression-alone group (15.2 vs. 9.5, for a difference of 5.7; 95% confidence interval, 0.1 to 11.3; P=0.046). The increases in the SF-36 physical-component summary scores in the fusion group remained greater than those in the decompression-alone group at 3 years and at 4 years (P=0.02 for both years). With respect to reductions in disability related to back pain, the changes in the Oswestry Disability Index scores at 2 years after surgery did not differ significantly between the study groups (-17.9 in the decompression-alone group and -26.3 in the fusion group, P=0.06). More blood loss and longer hospital stays occurred in the fusion group than in the decompression-alone group (P<0.001 for both comparisons). The cumulative rate of reoperation was 14% in the fusion group and 34% in the decompression-alone group (P=0.05). CONCLUSIONS: Among patients with degenerative grade I spondylolisthesis, the addition of lumbar spinal fusion to laminectomy was associated with slightly greater but clinically meaningful improvement in overall physical health-related quality of life than laminectomy alone. (Funded by the Jean and David Wallace Foundation and others; SLIP ClinicalTrials.gov number, NCT00109213.).
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Laminectomía , Vértebras Lumbares/cirugía , Fusión Vertebral , Estenosis Espinal/cirugía , Espondilolistesis/cirugía , Anciano , Anciano de 80 o más Años , Descompresión Quirúrgica , Evaluación de la Discapacidad , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/epidemiología , Reoperación/estadística & datos numéricos , Estenosis Espinal/complicaciones , Espondilolistesis/complicaciones , Resultado del TratamientoRESUMEN
BACKGROUND: Medicare beneficiaries hospitalized under observation status have significant cost-sharing responsibilities under Medicare Part B. Prior work has demonstrated an association between increased cost-sharing and health care rationing among low-income Medicare beneficiaries. The objective of this study was to explore the potential impact of observation cost-sharing on future medical decision making of Medicare beneficiaries. METHODS: Single-center pilot cohort study. A convenience sample of Medicare beneficiaries hospitalized under observation status care was surveyed. RESULTS: Out of 144 respondents, low-income beneficiaries were more likely to be concerned about the cost of their observation stay than higher-income respondents (70.7% vs29.3%, p = 0.015). If hospitalized under observation status again, there was a trend among low-income beneficiaries to request completion of their workup outside of the hospital (56.3% vs 43.8%), and to consider leaving against medical advice (AMA) (100% vs 0%), though these trends were not statistically significant (p = 0.30). CONCLUSION: The results of this pilot study suggest that low-income Medicare beneficiaries hospitalized under observation status have greater concerns about their cost-sharing obligations than their higher income peers. Cost-sharing for observation care may have unintended consequences on utilization for low-income beneficiaries. Future studies should examine this potential relationship on a larger scale.
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Unidades de Observación Clínica/economía , Seguro de Costos Compartidos , Medicare , Anciano , Femenino , Gastos en Salud , Accesibilidad a los Servicios de Salud , Humanos , Masculino , Proyectos Piloto , Encuestas y Cuestionarios , Estados UnidosRESUMEN
BACKGROUND: Overactive bladder (OAB) affects millions of women. It is important to assess knowledge and attitude in affected patients. The study objective was to develop surveys to assess OAB knowledge and OAB related attitude, and its association with OAB treatment status. METHODS: Systematic literature review and qualitative analysis of patient and provider focus groups helped identify OAB knowledge and attitude survey items. We determined psychometric properties of the two surveys in a cross-sectional sample of 104 women, 27% of whom had received OAB treatment. RESULTS: The OAB-knowledge survey consisted of 16 items and 3 condition-related concepts: perception of OAB; cause and information; and signs of OAB. The OAB-attitude survey consisted of 16 items and its concepts were treatment seeking; decision-making and effects. Both surveys demonstrated good construct validity and test-retest reliability ((≥ 0.60). In the cross-sectional validation sample, OAB-knowledge and attitude discriminated between those with different levels of ICIQ-UI scores. We observed some difference in the OAB knowledge, OAB attitude, and severity of symptoms between those treated for OAB vs. treatment naive. CONCLUSIONS: OAB knowledge and attitude surveys provide a novel tool to assess OAB domains in women. Though we did not find statistical significance in OAB knowledge and attitude scores across treatment status, they may be potentially modifiable factors that affect OAB treatment uptake and treatment compliance. Refinement of these surveys in diverse sub-populations is necessary. Our study provides effect sizes for OAB knowledge and attitude. These effect sizes can help development of fully powered trials to study the association between OAB knowledge and attitude, type and length of treatment, treatment compliance, and quality of life, leading to interventions for enhancing OAB care.
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Conocimientos, Actitudes y Práctica en Salud , Encuestas y Cuestionarios , Vejiga Urinaria Hiperactiva/psicología , Vejiga Urinaria Hiperactiva/terapia , Estudios de Cohortes , Estudios Transversales , Femenino , Humanos , Vejiga Urinaria Hiperactiva/epidemiologíaRESUMEN
OBJECTIVE: To determine whether patients who learned the views of an expert surgeons' panel's assessment of equipoise between 2 alternative operative treatments had increased likelihood of consenting to randomization. BACKGROUND: Difficulty obtaining patient consent to randomization is an important barrier to conducting surgical randomized clinical trials, the gold standard for generating clinical evidence. METHODS: Observational study of the rate of patient acceptance of randomization within a 5-center randomized clinical trial comparing lumbar spinal decompression versus lumbar spinal decompression plus instrumented fusion for patients with symptomatic grade I degenerative lumbar spondylolisthesis with spinal stenosis. Eligible patients were enrolled in the trial and then asked to accept randomization. A panel of 10 expert spine surgeons was formed to review clinical information and images for individual patients to provide an assessment of suitability for randomization. The expert panel vote was disclosed to the patient by the patient's surgeon before the patient decided whether to accept randomization or not. RESULTS: Randomization acceptance among eligible patients without expert panel review was 40% (19/48) compared with 81% (47/58) among patients undergoing expert panel review (Pâ<â0.001). Among expert-reviewed patients, randomization acceptance was 95% when all experts or all except 1 voted for randomization, 75% when 2 experts voted against randomization, and 20% with 3 or 4 votes against (Pâ<â0.001 for trend). CONCLUSIONS: Patients provided with an expert panel's assessment of their own suitability for randomization were twice as likely to agree to randomization compared with patients receiving only their own surgeon's recommendation.
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Laminectomía/métodos , Vértebras Lumbares , Estenosis Espinal/cirugía , Espondilolistesis/cirugía , Anciano , Anciano de 80 o más Años , Descompresión Quirúrgica/métodos , Femenino , Estudios de Seguimiento , Humanos , Laminectomía/instrumentación , Masculino , Persona de Mediana Edad , Selección de Paciente , Guías de Práctica Clínica como Asunto , Estudios Prospectivos , Estenosis Espinal/diagnóstico por imagen , Espondilolistesis/diagnóstico por imagen , Resultado del Tratamiento , Estados UnidosRESUMEN
The rate of contralateral prophylactic mastectomy (CPM) is rising rapidly, despite limited evidence about the procedure's relative benefits and harms. The objective of this study is to examine the impact of CPM on life expectancy (LE) and quality-adjusted life expectancy (QALE) in women with sporadic unilateral breast cancer. A Markov model was developed to compare 18 hypothetical cohorts of 45-year-old women with newly diagnosed unilateral, sporadic breast cancer treated with or without CPM. The probability of developing distant metastases by American Joint Committee on Cancer stage and molecular subtype was derived from British Columbia Cancer Agency data. Additional model parameters were identified from the medical literature. Sensitivity analyses were performed to examine the impact of plausible variations in key model parameters on results. CPM improved LE in all cohorts (range 0.06-0.54 years). Stage had more effect on LE than subtype (stage I mean, 0.44 years, stage III mean, 0.11 years). However, after adjusting for quality-of-life, No CPM was favored in all cohorts. Univariate sensitivity analysis demonstrated that the most influential model parameter was the post-CPM health state utility. The preferred strategy shifted from No CPM to CPM when the post-CPM utility exceeded 0.83 (base case value 0.81). PSA indicated that LE gains and QALE decreases were stable in all cohorts. The primary determinant of survival after unilateral breast cancer is stage at diagnosis. Our results suggest that routine CPM would not improve quality-adjusted survival for the majority of women with unilateral sporadic breast cancer.
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Mastectomía , Medición de Riesgo , Neoplasias de Mama Unilaterales/prevención & control , Neoplasias de Mama Unilaterales/cirugía , Colombia Británica/epidemiología , Toma de Decisiones Clínicas , Técnicas de Apoyo para la Decisión , Femenino , Humanos , Incidencia , Esperanza de Vida , Cadenas de Markov , Mastectomía/métodos , Metástasis de la Neoplasia , Pronóstico , Años de Vida Ajustados por Calidad de Vida , Sensibilidad y Especificidad , Neoplasias de Mama Unilaterales/epidemiologíaRESUMEN
DESCRIPTION: In November 2013, the American College of Cardiology and American Heart Association (ACC/AHA) released a clinical practice guideline on the treatment of blood cholesterol to reduce cardiovascular risk in adults. This synopsis summarizes the major recommendations. METHODS: In 2008, the National Heart, Lung, and Blood Institute convened the Adult Treatment Panel (ATP) IV to update the 2001 ATP-III cholesterol guidelines using a rigorous process to systematically review randomized, controlled trials (RCTs) and meta-analyses of RCTs that examined cardiovascular outcomes. The panel commissioned independent systematic evidence reviews on low-density lipoprotein cholesterol and non-high-density lipoprotein cholesterol goals in secondary and primary prevention and the effect of lipid drugs on atherosclerotic cardiovascular disease events and adverse effects. In September 2013, the panel's draft recommendations were transitioned to the ACC/AHA. RECOMMENDATIONS: This synopsis summarizes key features of the guidelines in 8 areas: lifestyle, groups shown to benefit from statins, statin safety, decision making, estimation of cardiovascular disease risk, intensity of statin therapy, treatment targets, and monitoring of statin therapy.
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Enfermedad de la Arteria Coronaria/prevención & control , Hipercolesterolemia/tratamiento farmacológico , HDL-Colesterol/sangre , LDL-Colesterol/sangre , Humanos , Inhibidores de Hidroximetilglutaril-CoA Reductasas/uso terapéutico , Hipercolesterolemia/sangre , Estilo de Vida , Monitoreo Fisiológico , Factores de RiesgoRESUMEN
OBJECTIVE: We sought to evaluate the construct validity of 3 health status classification system instruments-Health Utilities Index Mark 3 (HUI-3), EuroQol (EQ-5D), and Short Form 6D (SF-6D)-and a visual analog scale (VAS) for measuring utility scores in women with urge, stress, and mixed urinary incontinence. STUDY DESIGN: Utility scores were measured in 202 women with urinary incontinence. Pelvic floor symptom severity and quality of life were measured using the Pelvic Floor Distress Inventory and Pelvic Floor Impact Questionnaire, respectively. Construct, discriminant, and concurrent validity were evaluated. RESULTS: Significant correlations were noted between utility scores and the Pelvic Floor Distress Inventory (r = -0.22 to -0.42, P < .05) and the Pelvic Floor Impact Questionnaire (r = -0.32 to -0.50, P < .05). Mean utility scores were significantly lower for women with urge or mixed incontinence compared to stress incontinence for the EQ-5D (0.71 ± 0.23, 0.73 ± 0.26, and 0.81 ± 0.16, respectively, P = .02) and the SF-6D (0.76 ± 0.12, 0.74 ± 0.12, and 0.81 ± 0.11, respectively, P = .02) but not the HUI-3 or the VAS. There was a clinically important difference in utility scores (>0.03) between women with urge or mixed incontinence as compared to stress incontinence for the HUI-3, EQ-5D, and SF-6D but not the VAS. Utility preference scores were significantly lower for women with combined urinary and fecal incontinence (0.69-0.73) than urinary incontinence alone (0.77-0.84, P < .01). CONCLUSION: The HUI-3, EQ-5D, and SF-6D, but not the VAS, provide valid measurements for utility scores in women with stress, urge, and mixed urinary incontinence.
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Indicadores de Salud , Diafragma Pélvico/fisiopatología , Calidad de Vida , Incontinencia Urinaria de Esfuerzo/fisiopatología , Incontinencia Urinaria de Urgencia/fisiopatología , Incontinencia Urinaria/fisiopatología , Adulto , Anciano , Femenino , Humanos , Persona de Mediana Edad , Pennsylvania , Estudios Prospectivos , Psicometría , Reproducibilidad de los Resultados , Encuestas y CuestionariosRESUMEN
IMPORTANCE: Little is known regarding the durability of clinical practice guideline recommendations over time. OBJECTIVE: To characterize variations in the durability of class I ("procedure/treatment should be performed/administered") American College of Cardiology/American Heart Association (ACC/AHA) guideline recommendations. DESIGN, SETTING, AND PARTICIPANTS: Textual analysis by 4 independent reviewers of 11 guidelines published between 1998 and 2007 and revised between 2006 and 2013. MAIN OUTCOMES AND MEASURES: We abstracted all class I recommendations from the first of the 2 most recent versions of each guideline and identified corresponding recommendations in the subsequent version. We classified recommendations replaced by less determinate or contrary recommendations as having been downgraded or reversed; we classified recommendations for which no corresponding item could be identified as having been omitted. We tested for differences in the durability of recommendations according to guideline topic and underlying level of evidence using bivariable hypothesis tests and conditional logistic regression. RESULTS: Of 619 index recommendations, 495 (80.0%; 95% CI, 76.6%-83.1%) were retained in the subsequent guideline version, 57 (9.2%; 95% CI, 7.0%-11.8%) were downgraded or reversed, and 67 (10.8%; 95% CI, 8.4%-13.3%) were omitted. The percentage of recommendations retained varied across guidelines from 15.4% (95% CI, 1.9%-45.4%) to 94.1% (95% CI, 80.3%-99.3%; P < .001). Among recommendations with available information on level of evidence, 90.5% (95% CI, 83.2%-95.3%) of recommendations supported by multiple randomized studies were retained, vs 81.0% (95% CI, 74.8%-86.3%) of recommendations supported by 1 randomized trial or observational data and 73.7% (95% CI, 65.8%-80.5%) of recommendations supported by opinion (P = .001). After accounting for guideline-level factors, the probability of being downgraded, reversed, or omitted was greater for recommendations based on opinion (odds ratio, 3.14; 95% CI, 1.69-5.85; P < .001) or on 1 trial or observational data (odds ratio, 3.49; 95% CI, 1.45-8.41; P = .005) vs recommendations based on multiple trials. CONCLUSIONS AND RELEVANCE: The durability of class I cardiology guideline recommendations for procedures and treatments promulgated by the ACC/AHA varied across individual guidelines and levels of evidence. Downgrades, reversals, and omissions were most common among recommendations not supported by multiple randomized studies.
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Cardiología/normas , Guías de Práctica Clínica como Asunto/normas , American Heart Association , Medicina Basada en la Evidencia/normas , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto , Sociedades Médicas , Factores de Tiempo , Estados UnidosRESUMEN
PURPOSE: Recognition of the complex, multidimensional relationship between excess adiposity and cancer control outcomes has motivated the scientific community to seek new research models and paradigms. METHODS: The National Cancer Institute developed an innovative concept to establish a center grant mechanism in nutrition, energetics, and physical activity, referred to as the Transdisciplinary Research on Energetics and Cancer (TREC) Initiative. This paper gives an overview of the 2011-2016 TREC Collaborative Network and the 15 research projects being conducted at the centers. RESULTS: Four academic institutions were awarded TREC center grants in 2011: Harvard University, University of California San Diego, University of Pennsylvania, and Washington University in St. Louis. The Fred Hutchinson Cancer Research Center is the Coordination Center. The TREC research portfolio includes three animal studies, three cohort studies, four randomized clinical trials, one cross-sectional study, and two modeling studies. Disciplines represented by TREC investigators include basic science, endocrinology, epidemiology, biostatistics, behavior, medicine, nutrition, physical activity, genetics, engineering, health economics, and computer science. Approximately 41,000 participants will be involved in these studies, including children, healthy adults, and breast and prostate cancer survivors. Outcomes include biomarkers of cancer risk, changes in weight and physical activity, persistent adverse treatment effects (e.g., lymphedema, urinary and sexual function), and breast and prostate cancer mortality. CONCLUSION: The NIH Science of Team Science group will evaluate the value added by this collaborative science. However, the most important outcome will be whether this transdisciplinary initiative improves the health of Americans at risk of cancer as well as cancer survivors.
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Metabolismo Energético , Comunicación Interdisciplinaria , Neoplasias/prevención & control , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Investigación Biomédica , Niño , Preescolar , Ensayos Clínicos como Asunto , Estudios de Cohortes , Conducta Cooperativa , Diseño de Investigaciones Epidemiológicas , Femenino , Humanos , Lactante , Recién Nacido , Masculino , Persona de Mediana Edad , National Cancer Institute (U.S.) , National Institutes of Health (U.S.) , Neoplasias/epidemiología , Pronóstico , Factores de Tiempo , Estados Unidos/epidemiología , Adulto JovenRESUMEN
BACKGROUND: Prior studies of the Medicare Part D coverage gap are limited in generalizability and scope. OBJECTIVE: To determine the effect of the coverage gap on drugs used for asymptomatic (antihypertensive and lipid-lowering drugs) and symptomatic (pain relievers, acid suppressants, and antidepressants) conditions in elderly patients with hypertension and hyperlipidemia. DESIGN: Quasi-experimental study using pre-post design and contemporaneous control group. SETTING: Medicare claims files from 2005 and 2006 for 5% random sample of Medicare beneficiaries. PATIENTS: Part D plan enrollees with hypertension or hyperlipidemia aged 65 years or older who had no coverage, generic-only coverage, or both brand-name and generic coverage during the gap in 2006. Patients who were fully eligible for the low-income subsidy served as the control group. MEASUREMENTS: Monthly 30-day supply prescriptions available, medication adherence, and continuous medication gaps of 30 days or more for antihypertensive or lipid-lowering drugs; monthly 30-day supply prescriptions available for pain relievers, acid suppressants, or antidepressants before and after coverage gap entry. RESULTS: Patients with no gap coverage had a decrease in monthly antihypertensive and lipid-lowering drug prescriptions during the coverage gap. Nonadherence also increased in this group (antihypertensives: odds ratio [OR], 1.60 [95% CI, 1.50 to 1.71]; lipid-lowering drugs: OR, 1.59 [CI, 1.50 to 1.68]). The proportion of patients with no gap coverage who had continuous medication gaps in lipid-lowering medication use and antihypertensive use increased by an absolute 7.3% (OR, 1.38 [CI, 1.29 to 1.46]) and 3.2% (OR, 1.35 [CI, 1.25 to 1.45]), respectively, because of the coverage gap. Decreases in use were smaller for pain relievers and antidepressants and larger for acid suppressants in patients with no gap coverage. Patients with generic-only coverage had decreased use of cardiovascular medications but no change in use of drugs for symptomatic conditions. No measures changed in the brand-name and generic coverage groups. Results of sensitivity analyses were consistent with the main findings. LIMITATION: Because this study was nonrandomized, unobserved differences may still exist between study groups. CONCLUSION: The Part D coverage gap was associated with decreased use of medications for hypertension and hyperlipidemia in patients with no gap coverage and generic-only gap coverage. The proposed phasing out of the gap by 2020 will benefit such patients; however, use of low-value medications may also increase. PRIMARY FUNDING SOURCE: Penn-Pfizer Alliance and American Heart Association.
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Antihipertensivos/economía , Hipolipemiantes/economía , Cobertura del Seguro , Medicare Part D , Cumplimiento de la Medicación/estadística & datos numéricos , Honorarios por Prescripción de Medicamentos , Anciano , Analgésicos/uso terapéutico , Antiácidos/economía , Antiácidos/uso terapéutico , Antidepresivos/economía , Antidepresivos/uso terapéutico , Antihipertensivos/uso terapéutico , Prescripciones de Medicamentos/estadística & datos numéricos , Femenino , Humanos , Hiperlipidemias/tratamiento farmacológico , Hiperlipidemias/economía , Hipertensión/tratamiento farmacológico , Hipertensión/economía , Hipolipemiantes/uso terapéutico , Masculino , Inhibidores de la Bomba de Protones/economía , Inhibidores de la Bomba de Protones/uso terapéutico , Estados UnidosRESUMEN
Research on health information exposure focuses primarily on deliberate information-seeking behavior and its effects on health. By contrast, this study explores the complementary and perhaps more influential role of health information acquired through exposure to routinely used sources, called scanning. The authors hypothesized that scanning from nonmedical sources, both mediated and interpersonal, affects cancer screening and prevention decisions. The authors used a nationally representative longitudinal survey of 2,489 adults 40 to 70 years of age to analyze the effects of scanning on 3 cancer screening behaviors (mammography, prostate-specific antigen [PSA], and colonoscopy) and 3 prevention behaviors (exercising, eating fruits and vegetables, and dieting to lose weight). After adjustment for baseline behaviors and covariates, scanning at baseline predicted weekly exercise days 1 year later as well as daily fruit and vegetable servings 1 year later for those whose consumption of fruits and vegetables was already higher at baseline. Also, among those reporting timely screening mammogram behavior at baseline, scanning predicted repeat mammography. Scanning was marginally predictive of PSA uptake among those not reporting a PSA at baseline. Although there were strong cross-sectional associations, scanning did not predict dieting or colonoscopy uptake in longitudinal analyses. These analyses provide substantial support for a claim that routine exposure to health content from nonmedical sources affects specific health behaviors.
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Información de Salud al Consumidor/estadística & datos numéricos , Detección Precoz del Cáncer/estadística & datos numéricos , Conductas Relacionadas con la Salud , Conducta en la Búsqueda de Información , Adulto , Anciano , Recolección de Datos , Dieta/psicología , Dieta/estadística & datos numéricos , Ejercicio Físico/psicología , Femenino , Frutas , Humanos , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Estados Unidos , VerdurasRESUMEN
The amount of cancer-related information available to the general population continues to grow; yet, its effects are unclear. This study extends previous cross-sectional research establishing that cancer information seeking across a variety of sources is extensive and positively associated with engaging in health-related behaviors. The authors studied how active information seeking about cancer prevention influenced three healthy lifestyle behaviors using a 2-round nationally representative sample of adults ages 40-70 years (n = 1,795), using propensity scoring to control for potential confounders including baseline behavior. The adjusted odds of dieting at follow-up were 1.51 (95% CI: 1.05, 2.19) times higher for those who reported baseline seeking from media and interpersonal sources relative to nonseekers. Baseline seekers ate 0.59 (95% CI: 0.28, 0.91) more fruits and vegetable servings per day and exercised 0.36 (95% CI: 0.12, 0.60) more days per week at 1-year follow-up compared with nonseekers. The effects of seeking from media and friends/family on eating fruits and vegetables and exercising were independent of seeking from physicians. The authors offer several explanations for why information seeking predicts healthy lifestyle behaviors: information obtained motivates these behaviors; information sought teaches specific techniques; and the act of information seeking may reinforce a psychological commitment to dieting, eating fruits and vegetables, and exercising.
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Dieta/psicología , Ejercicio Físico/psicología , Conducta en la Búsqueda de Información , Relaciones Interpersonales , Estilo de Vida , Medios de Comunicación de Masas/estadística & datos numéricos , Neoplasias/prevención & control , Adulto , Anciano , Estudios Transversales , Dieta/estadística & datos numéricos , Familia , Femenino , Estudios de Seguimiento , Amigos , Frutas , Humanos , Masculino , Persona de Mediana Edad , Relaciones Médico-Paciente , VerdurasRESUMEN
OBJECTIVES: In recent years, there has been growth in the use of health technology assessment (HTA) for making decisions about the reimbursement, coverage, or guidance on the use of health technologies. Given this greater emphasis on the use of HTA, it is important to develop standards of good practice and to benchmark the various HTA organizations against these standards. METHODS: This study discusses the conceptual and methodological challenges associated with benchmarking HTA organizations and proposes a series of audit questions based on a previously published set of principles of good practice. RESULTS AND CONCLUSIONS: It is concluded that a benchmarking exercise would be feasible and useful, although the question of who should do the benchmarking requires further discussion. Key issues for further research are the alternative methods for weighting the various principles and for generating an overall score, or summary statement of adherence to the principles. Any weighting system, if developed, would need to be explored in different jurisdictions to assess the extent to which the relative importance of the principles is perceived to vary. Finally, the development and precise wording of the audit questions requires further study, with a view to making the questions as unambiguous as possible, and the reproducibility of the assessments as high as possible.
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Benchmarking/métodos , Política de Salud , Evaluación de la Tecnología Biomédica/métodos , Benchmarking/estadística & datos numéricos , Análisis Costo-Beneficio/métodos , Análisis Costo-Beneficio/estadística & datos numéricos , Recolección de Datos/métodos , Estudios de Evaluación como Asunto , Humanos , Evaluación de la Tecnología Biomédica/normas , Estados UnidosRESUMEN
Previous research suggests positive effects of health information seeking on prevention behaviors such as diet, exercise, and fruit and vegetable consumption among the general population. The current study builds upon this research by examining the effect of cancer patients' active information seeking from media and (nonmedical) interpersonal sources on fruit and vegetable consumption. The results of this longitudinal study are based on data collected from a randomly drawn sample from the Pennsylvania Cancer Registry, comprising breast, prostate, and colorectal cancer patients who completed mail surveys in the fall of 2006 and 2007. There was a 65% response rate for baseline subjects (resulting n = 2013); of those, 1,293 were interviewed one year later and 845 were available for final analyses. We used multiple imputation to replace missing data and propensity scoring to adjust for effects of possible confounders. There is a positive effect of information seeking at baseline on fruit and vegetable servings at follow-up; seekers consumed 0.43 (95% CI: 0.28 to 0.58) daily servings more than nonseekers adjusting for baseline consumption and other confounders. Active information seeking from media and interpersonal sources may lead to improved nutrition among the cancer patient population.
Asunto(s)
Información de Salud al Consumidor , Dieta , Frutas , Conducta en la Búsqueda de Información , Neoplasias , Verduras , Adulto , Anciano , Anciano de 80 o más Años , Estudios Transversales , Familia , Conducta Alimentaria , Femenino , Estudios de Seguimiento , Amigos , Encuestas Epidemiológicas , Humanos , Estudios Longitudinales , Masculino , Medios de Comunicación de Masas , Persona de Mediana Edad , Pennsylvania , Sistema de Registros , Adulto JovenAsunto(s)
Certificación , Consejos de Especialidades , Competencia Clínica , Humanos , Médicos , Estados UnidosRESUMEN
Despite acknowledging the value of clinical decision support systems (CDSS) in identifying risk for sepsis-induced health deterioration in-hospitalized patients, the relationship between display features, decision maker characteristics, and recognition of risk by the clinical decision maker remains an understudied, yet promising, area. The objective of this study is to explore the relationship between CDSS display design and perceived clinical risk of in-hospital mortality associated with sepsis. The study utilized data collected through in-person experimental sessions with 91 physicians from the general medical and surgical floors who were recruited across 12 teaching hospitals within the United States. Results of descriptive and statistical analyses provided evidence supporting the impact of display configuration and clinical case severity on perceived risk associated with in-hospital mortality. Specifically, findings showed that a high level of information (represented by the Predisposition, Infection, Response and Organ dysfunction (PIRO) score) and Figure display (as opposed to Text or baseline) increased awareness to recognizing the risk for in-hospital mortality of hospitalized sepsis patients. A CDSS display that synthesizes the optimal features associated with information level and design elements has the potential to enhance the quantification and communication of clinical risk in complex health conditions beyond sepsis.
Asunto(s)
Sistemas de Apoyo a Decisiones Clínicas , Sepsis , Mortalidad Hospitalaria , Humanos , Puntuaciones en la Disfunción de Órganos , Percepción , Sepsis/complicacionesRESUMEN
OBJECTIVE: The objective of the study was to evaluate the construct validity of 3 multiattribute health status classification system instruments, and a visual analog scale (VAS) for measuring utility scores for women with fecal incontinence (FI). STUDY DESIGN: Utility scores were measured in 200 women with 1 or more of the following diagnoses: fecal or urinary incontinence or pelvic organ prolapse. Pelvic floor symptom severity was measured using the Pelvic Floor Distress Inventory (PFDI-20), and quality of life was assessed with the Pelvic Floor Impact Questionnaire (PFIQ-7). Construct and concurrent validity were evaluated. RESULTS: After adjusting for age, comorbidities, urinary incontinence, and prolapse, utility scores were significantly lower for women with FI than women without FI for all health status instruments but not the VAS. All health status instruments had significant correlations with PFDI-20 and PFIQ-7 scores. CONCLUSION: The health status instruments provide valid utility scores in women with FI and would be useful in clinical trials and cost-effectiveness research.