Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 12 de 12
Filtrar
Mais filtros

Medicinas Complementares
Métodos Terapêuticos e Terapias MTCI
Base de dados
País/Região como assunto
Tipo de documento
Intervalo de ano de publicação
1.
Am J Surg ; 226(6): 917-920, 2023 12.
Artigo em Inglês | MEDLINE | ID: mdl-37940439

RESUMO

INTRODUCTION: The rectus to defect ratio (RDR) has been previously described as a metric which enables surgeons to estimate the need to perform additional myofascial release (AMR), in addition to open Rives-Stoppa retro-muscular hernia repair. We sought to validate this measurement specifically for patients undergoing robotic totally extraperitoneal (eTEP) hernia repair. METHODS: A retrospective chart review of 188 patients who underwent robotic ventral hernia repair via eTEP approach. RDR on preoperative CT was compared to the final operation rendered. The primary endpoint was the RDR's ability to predict the need for TAR to achieve fascial closure. RESULTS: Of 188 patients, 154 were repaired with rectus myofascial release, while 34 also required TAR. There was a linear decrease in the need for TAR with increasing RDR. RDR 1-1.49 (n â€‹= â€‹12) required TAR in 66.7 â€‹% of cases, RDR 1.5-1.99 (n â€‹= â€‹25) in 43.8 â€‹%, RDR 2-2.49 (n â€‹= â€‹31) in 29 â€‹%, and RDR >2.5 (n â€‹= â€‹151) in just 5.8 â€‹% CONCLUSION: The RDR accurately predicts the need for TAR to achieve fascial closure during robotic eTEP ventral hernia repair. An RDR >2.5 portends fascial closure without TAR 94.2 â€‹% of cases.


Assuntos
Hérnia Ventral , Hérnia Incisional , Laparoscopia , Procedimentos Cirúrgicos Robóticos , Humanos , Estudos Retrospectivos , Herniorrafia , Telas Cirúrgicas , Hérnia Ventral/cirurgia , Hérnia Incisional/cirurgia
2.
Clin Infect Dis ; 73(9): 1609-1616, 2021 11 02.
Artigo em Inglês | MEDLINE | ID: mdl-34079987

RESUMO

BACKGROUND: Candidemia is a common opportunistic infection causing substantial morbidity and mortality. Because of an increasing proportion of non-albicans Candida species and rising antifungal drug resistance, the Infectious Diseases Society of America (IDSA) changed treatment guidelines in 2016 to recommend echinocandins over fluconazole as first-line treatment for adults with candidemia. We describe candidemia treatment practices and adherence to the updated guidelines. METHODS: During 2017-2018, the Emerging Infections Program conducted active population-based candidemia surveillance at 9 US sites using a standardized case definition. We assessed factors associated with initial antifungal treatment for the first candidemia case among adults using multivariable logistic regression models. To identify instances of potentially inappropriate treatment, we compared the first antifungal drug received with species and antifungal susceptibility testing (AFST) results from initial blood cultures. RESULTS: Among 1835 patients who received antifungal treatment, 1258 (68.6%) received an echinocandin and 543 (29.6%) received fluconazole as initial treatment. Cirrhosis (adjusted odds ratio = 2.06; 95% confidence interval, 1.29-3.29) was the only underlying medical condition significantly associated with initial receipt of an echinocandin (versus fluconazole). More than one-half (n = 304, 56.0%) of patients initially treated with fluconazole grew a non-albicans species. Among 265 patients initially treated with fluconazole and with fluconazole AFST results, 28 (10.6%) had a fluconazole-resistant isolate. CONCLUSIONS: A substantial proportion of patients with candidemia were initially treated with fluconazole, resulting in potentially inappropriate treatment for those involving non-albicans or fluconazole-resistant species. Reasons for nonadherence to IDSA guidelines should be evaluated, and clinician education is needed.


Assuntos
Candidemia , Adulto , Antifúngicos/uso terapêutico , Candida , Candidemia/tratamento farmacológico , Candidemia/epidemiologia , Equinocandinas/uso terapêutico , Fluconazol/uso terapêutico , Humanos , Testes de Sensibilidade Microbiana , Estados Unidos/epidemiologia , Conduta Expectante
3.
Pharmacol Res Perspect ; 9(2): e00736, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-33694300

RESUMO

Chronic elevations in fatty acid metabolites termed prostaglandins can be found in circulation and in pancreatic islets from mice or humans with diabetes and have been suggested as contributing to the ß-cell dysfunction of the disease. Two-series prostaglandins bind to a family of G-protein-coupled receptors, each with different biochemical and pharmacological properties. Prostaglandin E receptor (EP) subfamily agonists and antagonists have been shown to influence ß-cell insulin secretion, replication, and/or survival. Here, we define EP3 as the sole prostanoid receptor family member expressed in a rat ß-cell-derived line that regulates glucose-stimulated insulin secretion. Several other agonists classically understood as selective for other prostanoid receptor family members also reduce glucose-stimulated insulin secretion, but these effects are only observed at relatively high concentrations, and, using a well-characterized EP3-specific antagonist, are mediated solely by cross-reactivity with rat EP3. Our findings confirm the critical role of EP3 in regulating ß-cell function, but are also of general interest, as many agonists supposedly selective for other prostanoid receptor family members are also full and efficacious agonists of EP3. Therefore, care must be taken when interpreting experimental results from cells or cell lines that also express EP3.


Assuntos
Glucose/metabolismo , Secreção de Insulina/fisiologia , Receptores de Prostaglandina E Subtipo EP3/metabolismo , Animais , Linhagem Celular Tumoral , Avaliação Pré-Clínica de Medicamentos/métodos , Secreção de Insulina/efeitos dos fármacos , Células Secretoras de Insulina , Ratos , Receptores de Prostaglandina E Subtipo EP3/antagonistas & inibidores
4.
Health Technol Assess ; 24(29): 1-314, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-32588816

RESUMO

BACKGROUND: Fragility fractures are fractures that result from mechanical forces that would not ordinarily result in fracture. OBJECTIVES: The objectives were to evaluate the clinical effectiveness, safety and cost-effectiveness of non-bisphosphonates {denosumab [Prolia®; Amgen Inc., Thousand Oaks, CA, USA], raloxifene [Evista®; Daiichi Sankyo Company, Ltd, Tokyo, Japan], romosozumab [Evenity®; Union Chimique Belge (UCB) S.A. (Brussels, Belgium) and Amgen Inc.] and teriparatide [Forsteo®; Eli Lilly and Company, Indianapolis, IN, USA]}, compared with each other, bisphosphonates or no treatment, for the prevention of fragility fracture. DATA SOURCES: For the clinical effectiveness review, nine electronic databases (including MEDLINE, EMBASE and the World Health Organization International Clinical Trials Registry Platform) were searched up to July 2018. REVIEW METHODS: A systematic review and network meta-analysis of fracture and femoral neck bone mineral density were conducted. A review of published economic analyses was undertaken and a model previously used to evaluate bisphosphonates was adapted. Discrete event simulation was used to estimate lifetime costs and quality-adjusted life-years for a simulated cohort of patients with heterogeneous characteristics. This was done for each non-bisphosphonate treatment, a strategy of no treatment, and the five bisphosphonate treatments previously evaluated. The model was populated with effectiveness evidence from the systematic review and network meta-analysis. All other parameters were estimated from published sources. An NHS and Personal Social Services perspective was taken, and costs and benefits were discounted at 3.5% per annum. Fracture risk was estimated from patient characteristics using the QFracture® (QFracture-2012 open source revision 38, Clinrisk Ltd, Leeds, UK) and FRAX® (web version 3.9, University of Sheffield, Sheffield, UK) tools. The relationship between fracture risk and incremental net monetary benefit was estimated using non-parametric regression. A probabilistic sensitivity analysis and scenario analyses were used to assess uncertainty. RESULTS: Fifty-two randomised controlled trials of non-bisphosphonates were included in the clinical effectiveness systematic review and an additional 51 randomised controlled trials of bisphosphonates were included in the network meta-analysis. All treatments had beneficial effects compared with placebo for vertebral, non-vertebral and hip fractures, with hazard ratios varying from 0.23 to 0.94, depending on treatment and fracture type. The effects on vertebral fractures and the percentage change in bone mineral density were statistically significant for all treatments. The rate of serious adverse events varied across trials (0-33%), with most between-group differences not being statistically significant for comparisons with placebo/no active treatment, non-bisphosphonates or bisphosphonates. The incremental cost-effectiveness ratios were > £20,000 per quality-adjusted life-year for all non-bisphosphonate interventions compared with no treatment across the range of QFracture and FRAX scores expected in the population eligible for fracture risk assessment. The incremental cost-effectiveness ratio for denosumab may fall below £30,000 per quality-adjusted life-year at very high levels of risk or for high-risk patients with specific characteristics. Raloxifene was dominated by no treatment (resulted in fewer quality-adjusted life-years) in most risk categories. LIMITATIONS: The incremental cost-effectiveness ratios are uncertain for very high-risk patients. CONCLUSIONS: Non-bisphosphonates are effective in preventing fragility fractures, but the incremental cost-effectiveness ratios are generally greater than the commonly applied threshold of £20,000-30,000 per quality-adjusted life-year. STUDY REGISTRATION: This study is registered as PROSPERO CRD42018107651. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 29. See the NIHR Journals Library website for further project information.


BACKGROUND: Fragility fractures are fractures that result from mechanical forces that would not ordinarily result in fracture, known as low-level (or 'low-energy') trauma. Some people are at particularly high risk of fragility fractures. The first treatment used is often a bisphosphonate, but non-bisphosphonate treatments are alternatives. AIMS: We aimed to determine how effective non-bisphosphonates {denosumab [Prolia®; Amgen Inc., Thousand Oaks, CA, USA], raloxifene [Evista®; Daiichi Sankyo Company, Ltd, Tokyo, Japan], romosozumab [Evenity®; Union Chimique Belge (UCB) S.A. (Brussels, Belgium) and Amgen Inc.] and teriparatide [Forsteo®; Eli Lilly and Company, Indianapolis, IN, USA]} are at preventing fractures, whether or not treatment has any risks for patients and whether or not the clinical benefits are achieved at a reasonable cost. METHODS: We have systematically identified and examined trials that assessed the clinical effects of non-bisphosphonates. For each clinical outcome, we have combined data from multiple trials to estimate the clinical effectiveness of each non-bisphosphonate treatment. We combined data from published sources in an economic model to estimate lifetime costs and clinical benefits for each non-bisphosphonate and compared these with the estimated costs and clinical outcomes for untreated patients and patients treated with bisphosphonates. RESULTS: All non-bisphosphonates reduced the risk of vertebral fractures compared with no treatment. For fractures at the hip or at any non-vertebral site, all of the non-bisphosphonates reduced the average number of fractures, but, for some non-bisphosphonates, we could not exclude the possibility that this was a chance finding. The chance of patients experiencing serious side effects was generally similar regardless of whether patients took non-bisphosphonates, bisphosphonates or placebo (a dummy pill). Blood clots were more common in patients taking raloxifene than in those taking placebo, but these were still a rare outcome (fewer than 1 in 100). The benefits of denosumab, teriparatide and romosozumab are few compared with their costs. For raloxifene, the risks generally outweigh the benefits. Treatment with bisphosphonates is likely to represent better value for money than treatment with non-bisphosphonates.


Assuntos
Conservadores da Densidade Óssea/uso terapêutico , Denosumab/uso terapêutico , Difosfonatos/uso terapêutico , Fraturas por Osteoporose , Cloridrato de Raloxifeno/uso terapêutico , Teriparatida/uso terapêutico , Ensaios Clínicos como Assunto , Análise Custo-Benefício , Humanos , Fraturas por Osteoporose/tratamento farmacológico , Fraturas por Osteoporose/prevenção & controle , Anos de Vida Ajustados por Qualidade de Vida , Resultado do Tratamento
5.
J Am Osteopath Assoc ; 120(5): 310-321, 2020 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-32337566

RESUMO

BACKGROUND: Polycystic ovary syndrome (PCOS), a common hormone disorder affecting reproductive and metabolic health of reproductive-age women, was shown in a previous study from these authors to be associated with increased sympathetic tone. Increased sympathetic tone contributes to long-term health risks for cardiovascular disease and promotes PCOS pathogenesis. OBJECTIVE: To determine whether weekly osteopathic manipulative treatment (OMT) improves physiologic measures of sympathetic tone in women with PCOS. METHODS: In the second phase of a larger study from this author group, 25 women with PCOS, aged 22 to 43 years, living in Erie, Pennsylvania, were recruited to participate in a randomized, controlled evaluation of OMT intervention. Participants were randomly assigned to either an OMT intervention or control group. The OMT group received weekly manipulation of Chapman points and rib-raising for viscerosomatic reflexes associated with the ovaries, adrenal glands, and heart for 12 consecutive weeks. Physiologic measures of sympathetic tone were collected, along with metabolic, endocrine, and reproductive measurements, both before the 3-month intervention and within 1 week of completing the intervention. Measurements included heart rate and blood pressure at rest and after 15 minutes of aerobic exercise, heart rate recovery after exercise, resting heart rate variability, serum androgen levels, body mass index, fasting blood glucose and insulin levels, and menstrual cycle length. RESULTS: Nineteen women completed the study. Comparing pre- and postintervention parameters, women with PCOS in the OMT intervention group experienced an improvement in postexercise systolic blood pressure (135.8 vs 129.1 mm Hg) and a trend toward heart rate recovery (23.2 vs 29.4 seconds). No significant improvements were found in the control group or in any other physiologic parameters measured. No significant improvements were found in the endocrine, metabolic, or reproductive parameters measured, although free testosterone was slightly lower after 3 months of weekly OMT (5.69 vs 4.64 pg/mL). CONCLUSION: Improvements in sympathetic tone after OMT suggest that weekly manipulation of Chapman points and viscerosomatic reflexes can be a useful adjunctive therapeutic option for women with PCOS. (ClinicalTrials.gov No. NCT03383484).


Assuntos
Osteopatia , Síndrome do Ovário Policístico , Pressão Sanguínea , Feminino , Frequência Cardíaca , Humanos , Projetos Piloto , Síndrome do Ovário Policístico/terapia
6.
J Am Osteopath Assoc ; 119(1): 7-17, 2019 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-30615047

RESUMO

BACKGROUND: Polycystic ovary syndrome (PCOS) is a common hormone disorder that affects the reproductive, metabolic, and psychological health of reproductive-aged females, with a number of long-term health risks, including type 2 diabetes mellitus and cardiovascular sequelae. Sympathetic hyperactivity in affected persons may be involved in the pathogenesis of the disorder. OBJECTIVE: To determine whether physiologic and osteopathic measures of increased sympathetic tone correlate in a population of women with PCOS. METHODS: For this descriptive observational study, women with PCOS between the ages of 20 and 44 years were recruited. Physiologic measures of sympathetic tone (resting heart rate and blood pressure, resting heart rate variability, and postexercise heart rate recovery and blood pressure) were compared with osteopathic measures of sympathetic tone (Chapman points and viscerosomatic reflexes) for the heart, adrenal glands, and ovaries. RESULTS: Twenty-four women participated in the study. Overall, the participants exhibited both physiologic and osteopathic signs of increased sympathetic tone compared with reference values. In some participants, the number of osteopathic findings were greater than the number of physiologic findings of increased sympathetic tone. CONCLUSIONS: Women with PCOS exhibit increased sympathetic tone by physiologic and osteopathic measures, indicating the utility of assessing sympathetic hyperactivity in these patients by osteopathic methods. Osteopathic structural examination is a valuable diagnostic tool that may allow detection of sympathetic hyperactivity in women with PCOS even before physiologic symptoms manifest. The osteopathic indicators of increased sympathetic tone may represent potential therapeutic targets to improve health in this population. (ClinicalTrials.gov NCT03383484).


Assuntos
Medicina Osteopática/métodos , Síndrome do Ovário Policístico/fisiopatologia , Sistema Nervoso Simpático/fisiopatologia , Adulto , Pressão Sanguínea , Eletrocardiografia , Teste de Esforço , Feminino , Frequência Cardíaca , Humanos , Exame Físico
7.
Biol Psychiatry ; 83(3): 244-253, 2018 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-29217296

RESUMO

BACKGROUND: Many studies report smaller hippocampal and amygdala volumes in posttraumatic stress disorder (PTSD), but findings have not always been consistent. Here, we present the results of a large-scale neuroimaging consortium study on PTSD conducted by the Psychiatric Genomics Consortium (PGC)-Enhancing Neuroimaging Genetics through Meta-Analysis (ENIGMA) PTSD Working Group. METHODS: We analyzed neuroimaging and clinical data from 1868 subjects (794 PTSD patients) contributed by 16 cohorts, representing the largest neuroimaging study of PTSD to date. We assessed the volumes of eight subcortical structures (nucleus accumbens, amygdala, caudate, hippocampus, pallidum, putamen, thalamus, and lateral ventricle). We used a standardized image-analysis and quality-control pipeline established by the ENIGMA consortium. RESULTS: In a meta-analysis of all samples, we found significantly smaller hippocampi in subjects with current PTSD compared with trauma-exposed control subjects (Cohen's d = -0.17, p = .00054), and smaller amygdalae (d = -0.11, p = .025), although the amygdala finding did not survive a significance level that was Bonferroni corrected for multiple subcortical region comparisons (p < .0063). CONCLUSIONS: Our study is not subject to the biases of meta-analyses of published data, and it represents an important milestone in an ongoing collaborative effort to examine the neurobiological underpinnings of PTSD and the brain's response to trauma.


Assuntos
Adultos Sobreviventes de Eventos Adversos na Infância/estatística & dados numéricos , Hipocampo/patologia , Neuroimagem/estatística & dados numéricos , Caracteres Sexuais , Transtornos de Estresse Pós-Traumáticos/patologia , Adulto , Tonsila do Cerebelo/diagnóstico por imagem , Tonsila do Cerebelo/patologia , Estudos de Coortes , Corpo Estriado/diagnóstico por imagem , Corpo Estriado/patologia , Feminino , Hipocampo/diagnóstico por imagem , Humanos , Ventrículos Laterais/diagnóstico por imagem , Ventrículos Laterais/patologia , Imageamento por Ressonância Magnética/estatística & dados numéricos , Masculino , Metanálise como Assunto , Transtornos de Estresse Pós-Traumáticos/diagnóstico por imagem , Tálamo/diagnóstico por imagem , Tálamo/patologia
8.
Health Technol Assess ; 20(93): 1-154, 2016 12.
Artigo em Inglês | MEDLINE | ID: mdl-28005003

RESUMO

BACKGROUND: Asthma episodes and deaths are known to be seasonal. A number of reports have shown peaks in asthma episodes in school-aged children associated with the return to school following the summer vacation. A fall in prescription collection in the month of August has been observed, and was associated with an increase in the number of unscheduled contacts after the return to school in September. OBJECTIVE: The primary objective of the study was to assess whether or not a NHS-delivered public health intervention reduces the September peak in unscheduled medical contacts. DESIGN: Cluster randomised trial, with the unit of randomisation being 142 NHS general practices, and trial-based economic evaluation. SETTING: Primary care. INTERVENTION: A letter sent (n = 70 practices) in July from their general practitioner (GP) to parents/carers of school-aged children with asthma to remind them of the importance of taking their medication, and to ensure that they have sufficient medication prior to the start of the new school year in September. The control group received usual care. MAIN OUTCOME MEASURES: The primary outcome measure was the proportion of children aged 5-16 years who had an unscheduled medical contact in September 2013. Supporting end points included the proportion of children who collected prescriptions in August 2013 and unscheduled contacts through the following 12 months. Economic end points were quality-adjusted life-years (QALYs) gained and costs from an NHS and Personal Social Services perspective. RESULTS: There is no evidence of effect in terms of unscheduled contacts in September. Among children aged 5-16 years, the odds ratio (OR) was 1.09 [95% confidence interval (CI) 0.96 to 1.25] against the intervention. The intervention did increase the proportion of children collecting a prescription in August (OR 1.43, 95% CI 1.24 to 1.64) as well as scheduled contacts in the same month (OR 1.13, 95% CI 0.84 to 1.52). For the wider time intervals (September-December 2013 and September-August 2014), there is weak evidence of the intervention reducing unscheduled contacts. The intervention did not reduce unscheduled care in September, although it succeeded in increasing the proportion of children collecting prescriptions in August as well as having scheduled contacts in the same month. These unscheduled contacts in September could be a result of the intervention, as GPs may have wanted to see patients before issuing a prescription. The economic analysis estimated a high probability that the intervention was cost-saving, for baseline-adjusted costs, across both base-case and sensitivity analyses. There was no increase in QALYs. LIMITATION: The use of routine data led to uncertainty in the coding of medical contacts. The uncertainty was mitigated by advice from a GP adjudication panel. CONCLUSIONS: The intervention did not reduce unscheduled care in September, although it succeeded in increasing the proportion of children both collecting prescriptions and having scheduled contacts in August. After September there is weak evidence in favour of the intervention. The intervention had a favourable impact on costs but did not demonstrate any impact on QALYs. The results of the trial indicate that further work is required on assessing and understanding adherence, both in terms of using routine data to make quantitative assessments, and through additional qualitative interviews with key stakeholders such as practice nurses, GPs and a wider group of children with asthma. TRIAL REGISTRATION: Current Controlled Trials ISRCTN03000938. FUNDING DETAILS: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 93. See the HTA programme website for further project information.


Assuntos
Asma/tratamento farmacológico , Serviços de Saúde/economia , Serviços de Saúde/estatística & dados numéricos , Adesão à Medicação/estatística & dados numéricos , Sistemas de Alerta/economia , Adolescente , Criança , Pré-Escolar , Análise Custo-Benefício , Feminino , Clínicos Gerais , Humanos , Masculino , Programas Nacionais de Saúde , Anos de Vida Ajustados por Qualidade de Vida , Estações do Ano , Reino Unido
9.
BMC Palliat Care ; 15: 55, 2016 Jul 07.
Artigo em Inglês | MEDLINE | ID: mdl-27388766

RESUMO

BACKGROUND: Most people with advanced dementia die in nursing homes where families may have to make decisions as death approaches. Discussions about end-of-life care between families and nursing home staff are uncommon, despite a range of potential benefits. In this study we aimed to examine practices relating to end-of-life discussions with family members of people with advanced dementia residing in nursing homes and to explore strategies for improving practice. METHODS: An ethnographic study in two nursing homes where the Compassion Intervention was delivered. The Compassion Intervention provides a model of end-of-life care engaging an Interdisciplinary Care Leader to promote integrated care, educate staff, support holistic assessments and discuss end of life with families. We used a framework approach, undertaking a thematic analysis of fieldwork notes and observations recorded in a reflective diary kept by the Interdisciplinary Care Leader, and data from in-depth interviews with 23 informants: family members, GPs, nursing home staff, and external healthcare professionals. RESULTS: Four major themes described strategies for improving practice: (i) educating families and staff about dementia progression and end-of-life care; (ii) appreciating the greater value of in-depth end-of-life discussions compared with simple documentation of care preferences; (iii) providing time and space for sensitive discussions; and (iv) having an independent healthcare professional or team with responsibility for end-of-life discussions. CONCLUSIONS: The Interdisciplinary Care Leader role offers a promising method for supporting and improving end-of-life care discussions between families of people with advanced dementia and nursing home staff. These strategies warrant further evaluation in nursing home settings.


Assuntos
Demência/enfermagem , Casas de Saúde , Assistência Terminal , Planejamento Antecipado de Cuidados/organização & administração , Cuidadores/psicologia , Empatia , Saúde da Família , Pesar , Educação em Saúde/organização & administração , Conhecimentos, Atitudes e Prática em Saúde , Pessoal de Saúde/educação , Pessoal de Saúde/organização & administração , Humanos , Entrevista Psicológica , Prontuários Médicos , Equipe de Assistência ao Paciente/organização & administração , Prática Profissional , Relações Profissional-Família , Responsabilidade Social , Apoio Social , Reino Unido
10.
Palliat Med ; 30(3): 279-95, 2016 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-26354388

RESUMO

BACKGROUND: The prevalence of dementia is rising worldwide and many people will die with the disease. Symptoms towards the end of life may be inadequately managed and informal and professional carers poorly supported. There are few evidence-based interventions to improve end-of-life care in advanced dementia. AIM: To develop an integrated, whole systems, evidence-based intervention that is pragmatic and feasible to improve end-of-life care for people with advanced dementia and support those close to them. DESIGN: A realist-based approach in which qualitative and quantitative data assisted the development of statements. These were incorporated into the RAND/UCLA appropriateness method to achieve consensus on intervention components. Components were mapped to underlying theory of whole systems change and the intervention described in a detailed manual. SETTING/PARTICIPANTS: Data were collected from people with dementia, carers and health and social care professionals in England, from expert opinion and existing literature. Professional stakeholders in all four countries of the United Kingdom contributed to the RAND/UCLA appropriateness method process. RESULTS: A total of 29 statements were agreed and mapped to individual, group, organisational and economic/political levels of healthcare systems. The resulting main intervention components are as follows: (1) influencing local service organisation through facilitation of integrated multi-disciplinary care, (2) providing training and support for formal and informal carers and (3) influencing local healthcare commissioning and priorities of service providers. CONCLUSION: Use of in-depth data, consensus methods and theoretical understanding of the intervention components produced an evidence-based intervention for further testing in end-of-life care in advanced dementia.


Assuntos
Prestação Integrada de Cuidados de Saúde/organização & administração , Demência/terapia , Casas de Saúde/normas , Assistência Terminal/organização & administração , Atitude do Pessoal de Saúde , Prestação Integrada de Cuidados de Saúde/normas , Humanos , Modelos Organizacionais , Cuidados Paliativos/organização & administração , Cuidados Paliativos/normas , Qualidade de Vida , Assistência Terminal/normas , Reino Unido
11.
Pharmacoeconomics ; 33(11): 1187-94, 2015 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-26017401

RESUMO

The National Institute for Health and Care Excellence (NICE) invited Dendreon, the company manufacturing sipuleucel-T, to submit evidence for the clinical and cost effectiveness of sipuleucel-T for asymptomatic or minimally symptomatic, metastatic, non-visceral hormone-relapsed prostate cancer patients in whom chemotherapy is not yet clinically indicated, as part of NICE's single technology appraisal process. The comparator was abiraterone acetate (AA) or best supportive care (BSC). The School of Health and Related Research at the University of Sheffield was commissioned to act as the Evidence Review Group (ERG). This paper describes the company submission (CS), ERG review, and subsequent decision of the NICE Appraisal Committee (AC). The ERG produced a critical review of the clinical and cost-effectiveness evidence of sipuleucel-T based upon the CS. Clinical-effectiveness data relevant to the decision problem were taken from three randomised controlled trials (RCTs) of sipuleucel-T and a placebo (PBO) comparator of antigen-presenting cells (APC) being re-infused (APC-PBO) (D9901, D9902A and D9902B), and one RCT (COU-AA-302) of AA plus prednisone vs. PBO plus prednisone. Two trials reported a significant advantage for sipuleucel-T in median overall survival compared with APC-PBO: for trial D9901, an adjusted hazard ratio (HR) 0.47; (95 % confidence interval [CI] 0.29, 0.76) p < 0.002; for D9902B, adjusted HR 0.78 (95 % CI 0.61, 0.98) p = 0.03. There was no significant difference between groups in D9902A, unadjusted HR 0.79 (95 % CI 0.48, 1.28) p = 0.331. Sipuleucel-T and APC-PBO groups did not differ significantly in time to disease progression, in any of the three RCTs. Most adverse events developed within 1 day of the infusion, and resolved within 2 days. The CS included an indirect comparison of sipuleucel-T (D9902B) and AA plus prednisone (COU-AA-302). As trials differed in prior use of chemotherapy, an analysis of only chemotherapy-naïve patients was included, in which the overall survival for sipuleucel-T and AA was not significantly different, HR 0.94 (95 % CI 0.69, 1.28) p = 0.699. The ERG had several concerns regarding the data and assumptions incorporated within the company's cost-effectiveness analyses and conducted exploratory analyses to quantify the impact of making alternative assumptions or using alternative data inputs. The deterministic incremental cost-effectiveness ratio (ICER) for sipuleucel-T vs. BSC when using the ERG's preferred data and assumptions was £ 108,585 per quality-adjusted life-year (QALY) in the whole licensed population and £ 61,204/QALY in the subgroup with low prostate-specific antigen at baseline. The ERG also conducted an incremental analysis comparing sipuleucel-T with both AA and BSC in the chemotherapy-naïve subgroup. Sipuleucel-T had a deterministic ICER of £ 111,682/QALY in this subgroup, when using the ERG's preferred assumptions, and AA was extendedly dominated. The ERG also concluded that estimates of costs and benefits for AA should be interpreted with caution given the limitations of the indirect comparison. The AC noted that the ICER for sipuleucel-T was well above the range usually considered cost effective, and did not recommend sipuleucel-T for the treatment of asymptomatic or minimally symptomatic, metastatic, non-visceral hormone-relapsed prostate cancer.


Assuntos
Tecnologia Biomédica/economia , Vacinas Anticâncer/economia , Neoplasias de Próstata Resistentes à Castração/economia , Extratos de Tecidos/economia , Tecnologia Biomédica/métodos , Vacinas Anticâncer/administração & dosagem , Vacinas Anticâncer/uso terapêutico , Análise Custo-Benefício , Humanos , Masculino , Metástase Neoplásica , Neoplasias de Próstata Resistentes à Castração/tratamento farmacológico , Neoplasias de Próstata Resistentes à Castração/mortalidade , Neoplasias de Próstata Resistentes à Castração/patologia , Anos de Vida Ajustados por Qualidade de Vida , Extratos de Tecidos/administração & dosagem , Extratos de Tecidos/uso terapêutico , Resultado do Tratamento
12.
Oncol Nurs Forum ; 30(1): 131-4, 2003.
Artigo em Inglês | MEDLINE | ID: mdl-12515991

RESUMO

PURPOSE/OBJECTIVES: To determine the feasibility of conducting trials of educational interventions regarding pain and quality of life (QOL) with people who call the National Cancer Institute's Cancer Information Service (CIS). DESIGN: Descriptive. SETTING: North Central CIS, located at the University of Wisconsin Comprehensive Cancer Center in Madison. SAMPLE: Callers to the North Central CIS who self-identified as people diagnosed with cancer or as family members or friends of people diagnosed with cancer were eligible. 102 people with cancer and 103 significant others answered questions concerning the feasibility of a pain study, and 101 significant others completed questions about the feasibility of a QOL study. METHODS: Eligible CIS callers were invited at the end of usual service to participate in a research study. Those who agreed were asked structured questions regarding pain or QOL. MAIN RESEARCH VARIABLES: Response rate, length of time to complete recruitment, concerns about reporting pain and using analgesics, concerns about QOL, demographic variables, and willingness to join a hypothetical study. FINDINGS: The majority of callers had concerns about pain and QOL, and the vast majority (78%-89%) of participants indicated a willingness to join a future educational intervention study. CONCLUSIONS: Using subjects recruited through CIS, conducting trials of brief telephone interventions designed to help patients overcome barriers to pain management or assist families in addressing QOL concerns may be feasible. IMPLICATIONS FOR NURSING: Researchers may wish to consider the opportunities afforded by collaborating with CIS colleagues in planning and conducting studies of educational interventions.


Assuntos
Serviços de Informação/estatística & dados numéricos , Neoplasias/epidemiologia , Dor/epidemiologia , Dor/prevenção & controle , Educação de Pacientes como Assunto/métodos , Comorbidade , Estudos de Viabilidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Prevalência , Qualidade de Vida , Projetos de Pesquisa
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA