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1.
Gac. sanit. (Barc., Ed. impr.) ; 34(5): 459-467, sept.-oct. 2020. tab, graf
Artigo em Inglês | IBECS-Express | IBECS | ID: ibc-ET1-6446

RESUMO

OBJECTIVE: To explore healthcare professionals' opinions about low-value practices, identify practices of this kind possibly present in the hospital and barriers and facilitators to reduce them. Low-value practices include those with little or no clinical benefit that may harm patients or lead to a waste of resources. METHOD: Using a mixed methodology, we carried out a survey and two focus groups in a tertiary hospital. In the survey, we assessed doctors' agreement, subjective adherence and perception of usefulness of 134 recommendations to reduce low-value practices from local and international initiatives. We also identified low-value practices possibly present in the hospital. In the focus groups with professionals from surgical and medical fields, using a phenomenological approach, we identified additional low-value practices, barriers and facilitators to reduce them. RESULTS: 169 doctors of 25 specialties participated (response rate: 7%-100%). Overall agreement with recommendations, subjective adherence and usefulness were 83%, 90% and 70%, respectively. Low-value practices form 22 recommendations (16%) were considered as possibly present in the hospital. In the focus groups, the professionals identified seven more. Defensive medicine and scepticism due to contradictory evidence were the main barriers. Facilitators included good leadership and coordination between professionals. CONCLUSIONS: High agreement with recommendations to reduce low-value practices and high perception of usefulness reflect great awareness of low-value care in the hospital. However, there are several barriers to reduce them. Interventions to reduce low-value practices should foster confidence in decision-making processes between professionals and patients and provide trusted evidence


OBJETIVO: Explorar las opiniones de profesionales sanitarios sobre las prácticas de poco valor, identificar aquellas posiblemente presentes en el hospital y las barreras y los facilitadores para reducirlas. Las prácticas de poco valor incluyen aquellas con poco beneficio clínico que pueden perjudicar a los pacientes o desperdiciar recursos. MÉTODO: Usando una metodología mixta se llevaron a cabo una encuesta y varios grupos focales en un hospital terciario. En la encuesta se evaluó el grado de acuerdo, la adherencia subjetiva y la percepción de utilidad de 134 recomendaciones para reducir las prácticas de poco valor de iniciativas locales e internacionales, y se identificaron aquellas que podrían estar realizándose en el hospital. En dos grupos focales con profesionales de campos médicos y quirúrgicos, utilizando un enfoque fenomenológico, se identificaron prácticas de poco valor adicionales, barreras y facilitadores para reducirlas. RESULTADOS: En la encuesta participaron 169 médicos de 25 especialidades (tasa de respuesta: 7-100%). El acuerdo con las recomendaciones, la adherencia subjetiva y la utilidad fueron del 83%, el 90% y el 70%, respectivamente. Se identificaron prácticas de poco valor de 22 recomendaciones (16%) posiblemente presentes en el hospital. En los grupos focales se identificaron siete prácticas de poco valor adicionales; la medicina defensiva y el escepticismo debido a evidencia contradictoria como principales barreras; y un buen liderazgo y la coordinación entre profesionales como facilitadores. CONCLUSIONES: El alto grado de acuerdo con las recomendaciones para reducir las prácticas de poco valor y la alta percepción de utilidad reflejan una gran concienciación sobre este problema en el hospital. Sin embargo, existen numerosas barreras para eliminarlas. Las intervenciones para reducirlas deberían fomentar la confianza en la toma de decisiones entre profesionales y pacientes, y proporcionar una evidencia confiable

2.
Eur J Haematol ; 105(6): 741-750, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-32749010

RESUMO

BACKGROUND: Abnormal coagulation parameters have been reported in COVID-19-infected patients. Although the underlying mechanism of COVID-19 coagulopathy remains unknown, it has been suggested to be a form of disseminated intravascular coagulation (DIC). OBJECTIVES: The aim of our study was to analyze the coagulation parameters of patients with COVID-19, determine whether coagulation factors consumption occurs and identify potential prognostic biomarkers of the disease. PATIENTS/METHODS: Blood samples from hospitalized patients with COVID-19 pneumonia were collected. We performed basic coagulation tests and quantification of coagulation factors and physiological inhibitor proteins. Laboratory data were compared with clinical data and outcomes. RESULTS: The study involved 206 patients (63.6% male). D-dimer was particularly elevated (median 450 ng/mL; IQR 222.5-957.3). Free protein S levels were below the normal range (median 56.6%; IQR: 43.6-68.9), and factor VIII showed an increasing trend (median 173.4%; IQR: 144.1-214.9). However, all coagulation factors were within normal limits. We found no correlation between abnormal coagulation parameters and thrombosis, except for higher D-dimer (HR 1.99; 95% CI 1.3-3.1; P = .002). CONCLUSIONS: COVID-19 is associated with coagulopathy that correlates with poor prognosis. However, we did not demonstrate a consumption of coagulation factors, as seen in DIC.


Assuntos
Betacoronavirus/patogenicidade , Infecções por Coronavirus/complicações , Síndrome da Liberação de Citocina/complicações , Coagulação Intravascular Disseminada/complicações , Fator VIII/metabolismo , Pneumonia Viral/complicações , Trombose Venosa/complicações , Idoso , Idoso de 80 Anos ou mais , Biomarcadores/sangue , Testes de Coagulação Sanguínea , Plaquetas/patologia , Plaquetas/virologia , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/mortalidade , Infecções por Coronavirus/virologia , Síndrome da Liberação de Citocina/diagnóstico , Síndrome da Liberação de Citocina/mortalidade , Síndrome da Liberação de Citocina/virologia , Coagulação Intravascular Disseminada/diagnóstico , Coagulação Intravascular Disseminada/mortalidade , Coagulação Intravascular Disseminada/virologia , Feminino , Produtos de Degradação da Fibrina e do Fibrinogênio/metabolismo , Humanos , Pulmão/irrigação sanguínea , Pulmão/efeitos dos fármacos , Pulmão/patologia , Pulmão/virologia , Masculino , Pessoa de Meia-Idade , Pandemias , Pneumonia Viral/diagnóstico , Pneumonia Viral/mortalidade , Pneumonia Viral/virologia , Prognóstico , Proteína S/metabolismo , Estudos Retrospectivos , Índice de Gravidade de Doença , Análise de Sobrevida , Trombose Venosa/diagnóstico , Trombose Venosa/mortalidade , Trombose Venosa/virologia
3.
J Clin Epidemiol ; 126: 80-92, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32565214

RESUMO

OBJECTIVE: The objective of the study is to develop a pragmatic tool to prioritize clinical guideline (CG) questions for updating, the UpPriority tool. STUDY DESIGN AND SETTING: The development of this tool consisted of the following: (1) establishment of the working group, (2) generation of the initial version, (3) optimization of the tool (including an initial feasibility test, semistructured interviews, Delphi consensus survey, second feasibility test, external review, and pilot test), and (4) approval of the final version. RESULTS: A total of 87 participants including methodologists, clinicians, and other relevant stakeholders contributed to the development of the UpPriority tool. The tool consists of six items: (1) impact of outdated recommendations on safety, (2) availability of new relevant evidence, (3) context relevance of the clinical question, (4) methodological applicability of the clinical question, (5) user's interest, and (6) impact on access to health care. The UpPriority tool includes detailed guidance for using the tool and rating each item (using a 7-point Likert scale), for calculating and ranking the questions, and for summarizing results. CONCLUSION: The UpPriority tool could be useful for standardizing prioritization processes when updating CGs and for fostering more efficient use of resources in the CG field.

4.
Biochimie ; 173: 62-67, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31962182

RESUMO

The association between elevated early pregnancy fasting plasma total homocysteine (tHcy) and miscarriage risk was investigated prospectively in participants (n = 544) from the Reus-Tarragona Birth Cohort study. Pregnancy was confirmed before 12 gestational weeks (GW) by ultrasound scan and a fasting blood sample collected. Pregnancies with complications other than miscarriages were excluded. Miscarriages were diagnosed by ultrasound scan and gestational age at the time of miscarriage estimated by embryo size, where possible. Cases in which blood samples were collected more than a week after the miscarriage, or the miscarriage was of known cause, were excluded. Fasting plasma folate, vitamin B12, tHcy, cotinine (biomarker of smoking), red blood cell (RBC) folate, MTHFR 677C > T (rs1801133) and SLC19A1 80G>A (rs1051266) genotypes were determined. The exposed group consisted of participants with first trimester tHcy ≥ P90 (7.1 µmol/L) (n = 57) and unexposed of those with tHcy < P90 (n = 487). Adherence to folic acid supplement recommendations, plasma folate, plasma vitamin B12, RBC folate and prevalence of optimal RBC folate status (≥ 906 µmol/L) were lower in the exposed compared to unexposed group. The prevalences of the MTHFR 677 TT genotype and miscarriage were higher in the exposed group. The relative risks (95% CI) of pregnancy ending in miscarriage were 2.5 (1.1, 5.7) and 2.1 (1.0, 4.5) for participants in the high tHcy and suboptimal RBC folate groups (compared to the reference groups) respectively. Adherence to folic acid supplement recommendations was positively associated, while the MTHFR 677 TT versus CC genotype and smoking versus non-smoking were negatively associated, with RBC folate status.

5.
Gac Sanit ; 34(5): 459-467, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-30745093

RESUMO

OBJECTIVE: To explore healthcare professionals' opinions about low-value practices, identify practices of this kind possibly present in the hospital and barriers and facilitators to reduce them. Low-value practices include those with little or no clinical benefit that may harm patients or lead to a waste of resources. METHOD: Using a mixed methodology, we carried out a survey and two focus groups in a tertiary hospital. In the survey, we assessed doctors' agreement, subjective adherence and perception of usefulness of 134 recommendations to reduce low-value practices from local and international initiatives. We also identified low-value practices possibly present in the hospital. In the focus groups with professionals from surgical and medical fields, using a phenomenological approach, we identified additional low-value practices, barriers and facilitators to reduce them. RESULTS: 169 doctors of 25 specialties participated (response rate: 7%-100%). Overall agreement with recommendations, subjective adherence and usefulness were 83%, 90% and 70%, respectively. Low-value practices form 22 recommendations (16%) were considered as possibly present in the hospital. In the focus groups, the professionals identified seven more. Defensive medicine and scepticism due to contradictory evidence were the main barriers. Facilitators included good leadership and coordination between professionals. CONCLUSIONS: High agreement with recommendations to reduce low-value practices and high perception of usefulness reflect great awareness of low-value care in the hospital. However, there are several barriers to reduce them. Interventions to reduce low-value practices should foster confidence in decision-making processes between professionals and patients and provide trusted evidence.

6.
J Reprod Infant Psychol ; 38(1): 25-37, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-30777448

RESUMO

Objective: To study prospectively the effect of prenatal smoke exposure (PSE) on child neuropsychological function and intelligence quotient (IQ).Background: PSE has been associated with adverse effects on child neurodevelopment. However, some studies reported that these associations disappear after adjustment for potential confounders.Methods: A cohortof 248 mothers-child dyad was followed from the first trimester of pregnancy until children were 7.5 years old. PSE was recorded during pregnancy by questionnaire and plasma cotinine. The Wechsler Intelligence Scale for Children, the Neuropsychological Assessment of Executive Functions for Children (ENFEN) and the School Neuropsychological Maturity Questionnaire were administered at 7.5 years of age. The effect of PSE on child IQ and neuropsychological function was assessed with ANCOVA, adjusting for obstetric, neonatal and sociodemographic factors.Results: Children whose mothers smoked throughout pregnancy scored lower in interference (ENFEN) compared to unexposed children (F = 4.1; p = .008). The results showed no differences in other executive functions, verbal and visual memory and IQ between the PSE groups.Conclusion: PSE had little effect on child neuropsychological outcome and was limited to mental flexibility. Nevertheless, these findings support further efforts aimed at encouraging mothers to quit smoking in pregnancy.

7.
Stem Cells Transl Med ; 9(3): 351-363, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-31880859

RESUMO

Fetal programming has been proposed as a key mechanism underlying the association between intrauterine exposure to maternal diabetes and negative health outcomes in offspring. To determine whether gestational diabetes mellitus (GDM) might leave an imprint in fetal precursors of the amniotic membrane and whether it might be related to adverse outcomes in offspring, a prospective case-control study was conducted, in which amniotic mesenchymal stem cells (AMSCs) and resident macrophages were isolated from pregnant patients, with either GDM or normal glucose tolerance, scheduled for cesarean section. After characterization, functional characteristics of AMSCs were analyzed and correlated with anthropometrical and clinical variables from both mother and offspring. GDM-derived AMSCs displayed an impaired proliferation and osteogenic potential when compared with control cells, accompanied by superior invasive and chemotactic capacity. The expression of genes involved in the inflammatory response (TNFα, MCP-1, CD40, and CTSS) was upregulated in GDM-derived AMSCs, whereas anti-inflammatory IL-33 was downregulated. Macrophages isolated from the amniotic membrane of GDM mothers consistently showed higher expression of MCP-1 as well. In vitro studies in which AMSCs from healthy control women were exposed to hyperglycemia, hyperinsulinemia, and palmitic acid confirmed these results. Finally, genes involved in the inflammatory response were associated with maternal insulin sensitivity and prepregnancy body mass index, as well as with fetal metabolic parameters. These results suggest that the GDM environment could program stem cells and subsequently favor metabolic dysfunction later in life. Fetal adaptive programming in the setting of GDM might have a direct negative impact on insulin resistance of offspring.

8.
Cancers (Basel) ; 11(9)2019 Sep 13.
Artigo em Inglês | MEDLINE | ID: mdl-31540291

RESUMO

Molecular diagnosis of myeloid neoplasms (MN) is based on the detection of multiple genetic alterations using various techniques. Next-generation sequencing (NGS) has been proved as a useful method for analyzing many genes simultaneously. In this context, we analyzed diagnostic samples from 121 patients affected by MN and ten relapse samples from a subset of acute myeloid leukemia patients using two enrichment-capture NGS gene panels. Pathogenicity classification of variants was enhanced by the development and application of a custom onco-hematology score. A total of 278 pathogenic variants were detected in 84% of patients. For structural alterations, 82% of those identified by cytogenetics were detected by NGS, 25 of 31 copy number variants and three out of three translocations. The detection of variants using NGS changed the diagnosis of seven patients and the prognosis of 15 patients and enabled us to identify 44 suitable candidates for clinical trials. Regarding AML, six of the ten relapsed patients lost or gained variants, comparing with diagnostic samples. In conclusion, the use of NGS panels in MN improves genetic characterization of the disease compared with conventional methods, thus demonstrating its potential clinical utility in routine clinical testing. This approach leads to better-adjusted treatments for each patient.

9.
BMJ Open ; 9(9): e031767, 2019 09 24.
Artigo em Inglês | MEDLINE | ID: mdl-31551391

RESUMO

INTRODUCTION: The adaptation of guidelines is an increasingly used methodology for the efficient development of contextualised recommendations. Nevertheless, there is no specific reporting guidance. The essential Reporting Items of Practice Guidelines in Healthcare (RIGHT) statement could be useful for reporting adapted guidelines, but it does not address all the important aspects of the adaptation process. The objective of our project is to develop an extension of the RIGHT statement for the reporting of adapted guidelines (RIGHT-Ad@pt Checklist). METHODS AND ANALYSIS: To develop the RIGHT-Ad@pt Checklist, we will use a multistep process that includes: (1) establishment of a Working Group; (2) generation of an initial checklist based on the RIGHT statement; (3) optimisation of the checklist (an initial assessment of adapted guidelines, semistructured interviews, a Delphi consensus survey, an external review by guideline developers and users and a final assessment of adapted guidelines); and (4) approval of the final checklist. At each step of the process, we will calculate absolute frequencies and proportions, use content analysis to summarise and draw conclusions, discuss the results, draft a report and refine the checklist. ETHICS AND DISSEMINATION: We have obtained a waiver of approval from the Clinical Research Ethics Committee at the Hospital de la Santa Creu i Sant Pau (Barcelona, Spain). We will disseminate the RIGHT-Ad@pt Checklist by publishing into a peer-reviewed journal, presenting to relevant stakeholders and translating into different languages. We will continuously seek feedback from stakeholders, surveil new relevant evidence and, if necessary, update the checklist.


Assuntos
Lista de Checagem/métodos , Revisão da Pesquisa por Pares/métodos , Guias de Prática Clínica como Assunto , Projetos de Pesquisa/normas , Assistência à Saúde/métodos , Assistência à Saúde/normas , Medicina Baseada em Evidências/métodos , Humanos , Estudo de Prova de Conceito , Espanha
10.
Cancer Manag Res ; 11: 117-130, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30636891

RESUMO

Purpose: This evidence mapping aims to describe and assess the quality of available evidence in systematic reviews (SRs) on treatments for oral cancer. Materials and methods: We followed the methodology of Global Evidence Mapping. Searches in MEDLINE, EMBASE, Epistemonikos and The Cochrane Library were conducted to identify SRs on treatments for oral cancer. The methodological quality of SRs was assessed using the Assessing the Methodological Quality of Systematic Reviews-2 tool. We organized the results according to identified Population-Intervention-Comparison-Outcome (PICO) questions and presented the evidence mapping in tables and a bubble plot. Results: Fifteen SRs met the eligibility criteria, including 118 individual reports, of which 55.1% were randomized controlled clinical trials. Ten SRs scored "Critically low" methodological quality. We extracted 30 PICOs focusing on interventions such as surgery, radiotherapy, chemotherapy, targeted therapy and immunotherapy; 18 PICOs were for resectable oral cancer, of which 8 were reported as beneficial. There were 12 PICOs for unresectable oral cancer, of which only 2 interventions were reported as beneficial. Conclusion: There is limited available evidence on treatments for oral cancer. The methodological quality of most included SRs scored "Critically low". The main beneficial treatment reported by authors for patients with resectable oral cancer is surgery alone or in combination with radiotherapy or chemotherapy. Evidence about the benefits of the treatments for unresectable oral cancer is lacking. These findings highlight the need to address future research focused on new treatments and knowledge gaps in this field, and increased efforts are required to improve the methodology quality and reporting process of SRs on treatments for oral cancer.

11.
Semin Hematol ; 55(4): 189-196, 2018 10.
Artigo em Inglês | MEDLINE | ID: mdl-30502846

RESUMO

Bortezomib-melphalan-prednisone combination is one of the standards of care for nontransplant eligible patients with newly diagnosed multiple myeloma. However, bortezomib intravenous (twice weekly for 4 cycles then weekly for 5 cycles) results in ~13% of patients with grade 3-4 peripheral neuropathy. Bortezomib subcutaneous (SQ) and weekly delivery, improves tolerability without impairment of efficacy. The aim of this study was to evaluate the safety and effectiveness of SQ bortezomib-based combinations in nontransplant eligible patients with newly diagnosed myeloma in a real-world setting. A total of 135 patients (median age [range] = 76 [58-89], International Staging System-III = 54%, median follow-up = 14.8 months [1-40], Intensive group [twice weekly bortezomib] = 65%, Optimized group [weekly bortezomib] = 35%) were included and evaluable for safety, whereas 121 were evaluable for effectiveness. Overall response rate (95% CI) was 61% (53%, 71%) (complete response = 27%, very good partial response = 13%, and partial response = 21%) and median progression-free survival was 22.2 months (95% CI: 16.1-not reached). The 3-year overall survival was 75%. The most frequent grade 3-4 adverse events were thrombocytopenia (18%), neutropenia (17%), and anemia (11%). Peripheral neuropathy of any grade was observed in 44% of patients (2% with grade 3). Comparison between regimens (Intensive vs Optimized) showed similar overall response rate (57% vs 70%) and PFS (25 vs 19 months). A similar safety profile was observed between regimens. Thus, SQ bortezomib showed similar effectiveness and better tolerability as compared with results from intravenous bortezomib studies, and showing no differences either in effectiveness or safety in different bortezomib-based combinations.


Assuntos
Antineoplásicos/uso terapêutico , Bortezomib/uso terapêutico , Mieloma Múltiplo/tratamento farmacológico , Idoso , Idoso de 80 Anos ou mais , Antineoplásicos/farmacologia , Bortezomib/farmacologia , Feminino , Humanos , Injeções Subcutâneas , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Resultado do Tratamento
12.
Am J Clin Nutr ; 107(2): 173-182, 2018 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-29529156

RESUMO

Background: Periconception folic acid supplementation is widespread, but how it interacts with cobalamin status is rarely considered. Objective: The aim of this study was to investigate whether first-trimester folate-cobalamin interactions affect pregnancy cobalamin status, hematologic variables, and pregnancy outcomes. Design: In the longitudinal Reus-Tarragona Birth Cohort study from <12 gestational weeks throughout pregnancy, fasting plasma and red blood cell (RBC) folate, plasma cobalamin, holotranscobalamin (holoTC), methylmalonic acid (MMA), total homocysteine (tHcy), hemoglobin, mean cell volume (MCV), postglucose-load serum glucose, gestational hypertension, gestational age at birth, and birth weight were recorded in 563 participants. Results: The highest plasma folate concentrations occurred in the first trimester when folic acid supplement use was extensive. Supplementation beyond the first trimester interacted with time of pregnancy on plasma folate, RBC folate, and tHcy throughout pregnancy (P-interaction <0.001). Plasma folate and RBC folate were higher and tHcy was lower in continued supplement users than in nonusers. Elevated plasma folate (≥30 nmol/L) occurred in 78.9% of women who exceeded the recommended 400 µg folic acid/d. First-trimester folate-cobalamin status interactions were associated with MMA (P-interaction <0.001) throughout pregnancy. When plasma cobalamin was suboptimal (≤221 pmol/L; n = 36), participants with elevated plasma folate (n = 11) had higher MMA concentrations than did those with nonelevated plasma folate (n = 23). First-trimester folate-MMA status interactions were associated with MCV throughout pregnancy (P-interaction <0.01) and with cord plasma holoTC (P-interaction <0.05). The mean difference (95% CI) in MCV (fL) between women with elevated and nonelevated plasma folate status was -2.12 (-3.71, -0.52) for top-quartile plasma MMA (≥0.139 µmol/L) and 0.60 (-0.39, 1.60) for plasma MMA <0.139 µmol/L. Cord plasma holoTC was higher in women with elevated compared with nonelevated plasma folate status only for MMA <0.139 µmol/L. Folate-cobalamin interactions were not associated with the other investigated outcomes. Conclusion: First-trimester folate-cobalamin status interactions were associated with plasma MMA and MCV throughout pregnancy. This trial was registered at www.clinicaltrials.gov as NCT01778205.


Assuntos
Anemia Ferropriva/epidemiologia , Ácido Fólico/sangue , Resultado da Gravidez/epidemiologia , Vitamina B 12/sangue , Adulto , Anemia Ferropriva/sangue , Índice de Massa Corporal , Suplementos Nutricionais , Feminino , Homocisteína/sangue , Humanos , Ferro na Dieta/administração & dosagem , Estudos Longitudinais , Ácido Metilmalônico/sangue , Gravidez , Primeiro Trimestre da Gravidez/sangue , Prevalência , Fatores Socioeconômicos
13.
BMC Med Res Methodol ; 17(1): 135, 2017 Sep 07.
Artigo em Inglês | MEDLINE | ID: mdl-28882125

RESUMO

BACKGROUND: Gastrointestinal Stromal Tumours (GISTs) are the most common mesenchymal tumours. Currently, different pharmacological and surgical options are used to treat localised and metastatic GISTs, although this research field is broad and the body of evidence is scattered and expanding. Our objectives are to identify, describe and organise the current available evidence for GIST through an evidence mapping approach. METHODS: We followed the methodology of Global Evidence Mapping (GEM). We searched Pubmed, EMBASE, The Cochrane Library and Epistemonikos in order to identify systematic reviews (SRs) with or without meta-analyses published between 1990 and March 2016. Two authors assessed eligibility and extracted data. Methodological quality of the included systematic reviews was assessed using AMSTAR. We organised the results according to identified PICO questions and presented the evidence map in tables and a bubble plot. RESULTS: A total of 17 SRs met eligibility criteria. These reviews included 66 individual studies, of which three quarters were either observational or uncontrolled clinical trials. Overall, the quality of the included SRs was moderate or high. In total, we extracted 14 PICO questions from them and the corresponding results mostly favoured the intervention arm. CONCLUSIONS: The most common type of study used to evaluate therapeutic interventions in GIST sarcomas has been non-experimental studies. However, the majority of the interventions are reported as beneficial or probably beneficial by the respective authors of SRs. The evidence mapping is a useful and reliable methodology to identify and present the existing evidence about therapeutic interventions.


Assuntos
Prática Clínica Baseada em Evidências , Neoplasias Gastrointestinais/terapia , Tumores do Estroma Gastrointestinal/terapia , Humanos , Literatura de Revisão como Assunto
14.
BMJ Open ; 7(8): e017226, 2017 Aug 03.
Artigo em Inglês | MEDLINE | ID: mdl-28775194

RESUMO

INTRODUCTION: Due to a continuous emergence of new evidence, clinical guidelines (CGs) require regular surveillance of evidence to maintain their trustworthiness. The updating of CGs is resource intensive and time consuming; therefore, updating may include a prioritisation process to efficiently ensure recommendations remain up to date. The objective of our project is to develop a pragmatic tool to prioritise clinical questions for updating within a CG. METHODS AND ANALYSIS: To develop the tool, we will use the results and conclusions of a systematic review of methodological research on prioritisation processes for updating and will adopt a methodological approach we have successfully implemented in a previous experience.We will perform a multistep process including (1) generation of an initial version of the tool, (2) optimisation of the tool (feasibility test of the tool, semistructured interviews, Delphi consensus survey, external review by CG methodologists and users and pilot test of the tool) and (3) approval of the final version of the tool.At each step of the process, we will (1) calculate absolute frequencies and proportions (quantitative data), (2) use content analysis to summarise and draw conclusions (qualitative data) and (3) draft a final report, discuss results and refine the previous versions of the tool. Finally, we will calculate intraclass coefficients with 95% CIs for each item and overall as indicators of agreement among reviewers. ETHICS AND DISSEMINATION: We have obtained a waiver of approval from the Clinical Research Ethics Committee at the Hospital de la Santa Creu i Sant Pau (Barcelona). The results of the study will be published in peer-reviewed journal and communicated to interested stakeholders.The tool could support the standardisation of prioritisation processes for updating CGs and therefore have important implications for a more efficient use of resources in the CG field.


Assuntos
Assistência à Saúde/normas , Medicina Baseada em Evidências , Guias de Prática Clínica como Assunto , Melhoria de Qualidade , Inquéritos e Questionários , Humanos
15.
J Clin Epidemiol ; 86: 11-24, 2017 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-28549931

RESUMO

OBJECTIVES: The aim of the study was to identify and describe strategies to prioritize the updating of systematic reviews (SRs), health technology assessments (HTAs), or clinical guidelines (CGs). STUDY DESIGN AND SETTING: We conducted an SR of studies describing one or more methods to prioritize SRs, HTAs, or CGs for updating. We searched MEDLINE (PubMed, from 1966 to August 2016) and The Cochrane Methodology Register (The Cochrane Library, Issue 8 2016). We hand searched abstract books, reviewed reference lists, and contacted experts. Two reviewers independently screened the references and extracted data. RESULTS: We included 14 studies. Six studies were classified as descriptive (6 of 14, 42.9%) and eight as implementation studies (8 of 14, 57.1%). Six studies reported an updating strategy (6 of 14, 42.9%), six a prioritization process (6 of 14, 42.9%), and two a prioritization criterion (2 of 14, 14.2%). Eight studies focused on SRs (8 of 14, 57.1%), six studies focused on CGs (6 of 14, 42.9%), and none were about HTAs. We identified 76 prioritization criteria that can be applied when prioritizing documents for updating. The most frequently cited criteria were as follows: available evidence (19 of 76, 25.0%), clinical relevance (10 of 76; 13.2%), and users' interest (10 of 76; 13.2%). CONCLUSION: There is wide variability and suboptimal reporting of the methods used to develop and implement processes to prioritize updating of SRs, HTAs, and CGs.


Assuntos
Guias como Assunto/normas , Literatura de Revisão como Assunto , Avaliação da Tecnologia Biomédica/normas , Humanos
16.
Nutrients ; 8(10)2016 Oct 09.
Artigo em Inglês | MEDLINE | ID: mdl-27735840

RESUMO

The effect of the betaine: homocysteine methyltransferase BHMT c.716G>A (G: guanosine; A: adenosine) single nucleotide polymorphism (SNP) on the BHMT pathway is unknown during pregnancy. We hypothesised that it impairs betaine to dimethylglycine conversion and that folate status modifies its effect. We studied 612 women from the Reus Tarragona Birth Cohort from ≤12 gestational weeks (GW) throughout pregnancy. The frequency of the variant BHMT c.716A allele was 30.8% (95% confidence interval (CI): 28.3, 33.5). In participants with normal-high plasma folate status (>13.4 nmol/L), least square geometric mean [95% CI] plasma dimethylglycine (pDMG, µmol/L) was lower in the GA (2.35 [2.23, 2.47]) versus GG (2.58 [2.46, 2.70]) genotype at ≤12 GW (p < 0.05) and in the GA (2.08 [1.97, 2.19]) and AA (1.94 [1.75, 2.16]) versus GG (2.29 [2.18, 2.40]) genotypes at 15 GW (p < 0.05). No differences in pDMG between genotypes were observed in participants with possible folate deficiency (≤13.4 nmol/L) (p for interactions at ≤12 GW: 0.023 and 15 GW: 0.038). PDMG was lower in participants with the AA versus GG genotype at 34 GW (2.01 [1.79, 2.25] versus 2.44 [2.16, 2.76] and at labour, 2.51 [2.39, 2.64] versus 3.00 [2.84, 3.18], (p < 0.01)). Possible deficiency compared to normal-high folate status was associated with higher pDMG in multiple linear regression analysis (ß coefficients [SEM] ranging from 0.07 [0.04], p < 0.05 to 0.20 [0.04], p < 0.001 in models from early and mid-late pregnancy) and the AA compared to GG genotype was associated with lower pDMG (ß coefficients [SEM] ranging from -0.11 [0.06], p = 0.055 to -0.23 [0.06], p < 0.001). CONCLUSION: During pregnancy, the BHMT pathway is affected by folate status and by the variant BHMT c.716A allele.


Assuntos
Betaína-Homocisteína S-Metiltransferase/genética , Betaína/metabolismo , Deficiência de Ácido Fólico/metabolismo , Ácido Fólico/sangue , Polimorfismo Genético , Sarcosina/análogos & derivados , Feminino , Regulação da Expressão Gênica , Genótipo , Humanos , Fenômenos Fisiológicos da Nutrição Materna , Gravidez , Sarcosina/metabolismo
17.
Transl Res ; 178: 1-12, 2016 12.
Artigo em Inglês | MEDLINE | ID: mdl-27469268

RESUMO

Angiopoietin-like protein 8 (ANGPTL8), a protein implicated in lipid and glucose homeostasis, is present only in mammals, suggesting that it is involved in processes unique to these vertebrates such as pregnancy and homeothermy. We explored the role of ANGPTL8 in maternal-fetal crosstalk and its relationship with newborn adiposity. In a longitudinal analysis of healthy pregnant women, ANGPTL8 levels decreased progressively during pregnancy although remained higher than levels in the postpartum period. In a cross-sectional observational study of women with or without gestational diabetes mellitus (GDM), and their offspring, ANGPTL8 levels were higher in venous cord blood than those in maternal blood and were significantly lower in GDM patients than those in healthy women. Infants small for gestational age and with low-fat mass had the highest ANGPTL8 cord blood levels. Studies in vitro revealed that ANGPTL8 was secreted by brown adipocytes and its expression was increased in experimental models of white-to-brown fat conversion. In addition, ANGPTL8 induced the expression of markers of brown adipocytes. The high levels of ANGPTL8 found in fetal life together with its relationship with newborn adiposity and brown adipose tissue point to ANGPTL8 as a potential new player in the modulation of the thermogenic machinery during the fetal-neonatal transition.


Assuntos
Tecido Adiposo Marrom/metabolismo , Angiopoietinas/sangue , Sistema Endócrino/metabolismo , Desenvolvimento Fetal , Hormônios Peptídicos/sangue , Adipócitos Marrons/metabolismo , Adulto , Proteínas Semelhantes a Angiopoietina , Animais , Feminino , Sangue Fetal/metabolismo , Humanos , Camundongos Endogâmicos C57BL , Fenótipo , Período Pós-Parto/metabolismo , Gravidez
18.
BMC Hematol ; 16: 14, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27190631

RESUMO

BACKGROUND: Multiple myeloma is a plasma cell tumour with an annual incidence in the UK of approximately 40-50 per million i.e. about 4500 new cases per annum. The triple combination cyclophosphamide, bortezomib (Velcade®) and dexamethasone (CVD) is an effective regimen at relapse and has emerged in recent years as the standard therapy at first relapse in the UK. Carfilzomib has good activity as a single agent in the relapsed setting, and it is expected that efficacy will be improved when used in combination with dexamethasone and cyclophosphamide. METHODS: MUK Five is a phase II open label, randomised, controlled, parallel group, multi-centre trial that will compare the activity of carfilzomib, cyclophosphamide and dexamethasone (CCD) with that of CVD, given over an equivalent treatment period (24 weeks), in participants with multiple myeloma at first relapse, or refractory to no more than 1 line of treatment. In addition, the study also aims to assess the utility of a maintenance schedule of carfilzomib in these participants. The primary objective of the trial is to assess whether CCD provides non-inferior activity in terms of ≥ VGPR rates at 24 weeks, and whether the addition of maintenance treatment with carfilzomib to CCD provides superior activity in terms of progression-free survival, as compared to CCD with no maintenance. Secondary objectives include comparing toxicity profiles, further summarizing and comparing the activity of the different treatment arms and analysis of the effect of each treatment arm on minimal residual disease status. DISCUSSION: The development of carfilzomib offers the opportunity to further explore the anti-tumour efficacy of proteasome inhibition and, based on the available evidence, it is important and timely to obtain data on the activity, toxicity and tolerability of this drug. In contrast to ongoing phase III trials, this phase II trial has a unique subset of participants diagnosed with multiple myeloma at first relapse or refractory to no more than 1 line of treatment and will also evaluate the utility of maintenance with carfilzomib for up to 18 months and investigate minimal residual disease status to provide information on depth of response and the prognostic impact thereof. TRIAL REGISTRATION: The trial is registered under ISRCTN17354232, December 2012.

19.
J Clin Epidemiol ; 77: 84-90, 2016 09.
Artigo em Inglês | MEDLINE | ID: mdl-27164275

RESUMO

OBJECTIVE: The objective of the present study was to determine the publication rate of cancer randomized controlled trial (RCTs) and to analyze the determinants of the publication, as well as to estimate the possible existence of a location and time lag bias. We also described the bibliometric characteristics of the publications. STUDY DESIGN AND SETTING: We conducted an observational study that identified publications resulting from RCTs involving cancer-related drug products. These studies were authorized and registered by the Spanish Agency of Medicines and Medical Devices between 1999 and 2003. RESULTS: We identified 168 publications of 303 RCTs, resulting in a publication rate of 55.4% after a mean follow-up of 12 years. The only factor associated to the likelihood of nonpublication was the study setting favoring only national RCTs (odds ratio 2.7; 95% confidence interval 1.5-4.8). Type of sponsor did not seem to be associated, although the largest volume of nonpublished trials is international, industry-sponsored. Positive results seemed to be associated to a publication in a higher impact factor journal and a shorter time-to-publication. CONCLUSIONS: About half of the cancer RCTs during the target period have not been published. The national setting is a factor associated to nonpublication, whereas the direction of results determines its dissemination (impact factor and timely publication).


Assuntos
Neoplasias/tratamento farmacológico , Viés de Publicação/estatística & dados numéricos , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Bibliometria , Humanos , Disseminação de Informação , Publicações/normas , Publicações/estatística & dados numéricos , Fatores de Tempo
20.
Av. diabetol ; 31(2): 45-59, mar.-abr. 2015. tab
Artigo em Espanhol | IBECS | ID: ibc-136036

RESUMO

La diabetes es una de las complicaciones metabólicas más frecuentes de la gestación y se asocia a un incremento del riesgo de morbimortalidad maternal y fetal, que pueden evitarse y/o reducirse con un adecuado control. En la diabetes pregestacional, la preparación específica previa a la gestación es indispensable para intentar conseguir un control glucémico lo más próximo a la normalidad, evaluar complicaciones y revisar las pautas de tratamientos farmacológicos. En el caso de la diabetes gestacional, el tratamiento de esta entidad ha demostrado disminuir la tasa de complicaciones maternas y perinatales, por lo que su diagnóstico está justificado. En relación con la estrategia diagnóstica, ante la falta de consenso y la controversia desatada tras la aparición de los nuevos criterios IADPSG, el grupo ha decidido mantener la misma estrategia diagnóstica en 2 pasos y con los mismos puntos de corte hasta disponer de datos sólidos que avalen la introducción de nuevos criterios


Diabetes is one of the most common metabolic complications of pregnancy, and is associated with an increased risk of maternal and foetal morbidity and mortality that can be prevented and/or reduced with adequate glycaemic control. In pre-gestational diabetes, specific preparation prior to the pregnancy is essential in order to achieve glycaemic control near to normal as possible and to evaluate complications and review pharmacologic treatment prescription. The treatment of gestational diabetes has been shown to decrease the rate of maternal and perinatal complications, thus its diagnosis is justified. As regards the diagnostic strategy and due to the lack of consensus and the controversy arising after the publication of the new International Association of the Diabetes and Pregnancy Study Groups (IADPSG), the group has decided to keep the same diagnostic strategy in two stages, and with the same cut-off points, until there are solid data available that support the introduction of new criteria


Assuntos
Humanos , Feminino , Gravidez , Diabetes Gestacional/terapia , Diabetes Mellitus/terapia , Gravidez em Diabéticas/terapia , Fatores de Risco , Complicações na Gravidez/epidemiologia , Complicações do Diabetes/epidemiologia , Suplementos Nutricionais , Triagem Neonatal/métodos
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