Your browser doesn't support javascript.
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 8.931
Filtrar
1.
Medicine (Baltimore) ; 98(37): e17114, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31517847

RESUMO

BACKGROUND: We will investigate the efficacy and safety of weekly cisplatin (WC) for treatment of patients with breast cancer (BC) systematically. METHODS: This study will describe and critically appraise shared decision approaches used in randomized controlled trials of WC for treatment of patients with BC. We will comprehensively search the following databases: PubMed, EMBASE, Web of Science, Cochrane Library, CINAHL, PsycINFO, Allied and Complementary Medicine Database, Wanfang, and Chinese Biomedical Literature Database from inception through July 1, 2019. We will utilize RevMan V.5.3 software (London, UK) for statistical analysis. RESULTS: This study will systematically explore the efficacy and safety of WC for the treatment of patients with BC through evaluating primary outcomes of overall survival, pathological complete response; and secondary outcomes of cancer-specific survival, recurrence-free survival, disease-free survival, quality of life, and toxicities. CONCLUSION: This study will provide latest evidence of WC for the treatment of patients with BC. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42019145358.


Assuntos
Neoplasias da Mama/tratamento farmacológico , Cisplatino/normas , Adulto , Cisplatino/uso terapêutico , Feminino , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Resultado do Tratamento
2.
Medicine (Baltimore) ; 98(37): e17116, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31517848

RESUMO

BACKGROUND: Buyang Huanwu Tang (BHT) is a well-known herbal complex used for stroke treatment and has been used mainly during post-stroke rehabilitation in East Asia. In this review, we aim to evaluate the efficacy and safety of BHT as a treatment for post-stroke fatigue (PSF). METHODS: Eight databases will be searched for relevant studies from inception to the present date. We will include randomized controlled trials (RCTs), which assess the effect and safety of BHT for the treatment of PSF. The methodological qualities, including the risk of bias (RoB), will be evaluated using the Cochrane RoB assessment tool. After screening the studies, a meta-analysis of the RCTs will be done. RESULTS: This study will provide high-quality synthesis of current evidence of BHT for PSF. CONCLUSION: The conclusion of our systematic review will provide evidence to judge whether BHT is an effective intervention for patients with PSF. ETHICS AND DISSEMINATION: Ethical approval is not required, as this study is based on the review of published research. This review will be published in a peer-reviewed journal and disseminated both electronically and in print. TRIAL REGISTRATION NUMBER: PROSPERO CRD42019130178.


Assuntos
Medicamentos de Ervas Chinesas/normas , Fadiga/tratamento farmacológico , Acidente Vascular Cerebral/complicações , Medicamentos de Ervas Chinesas/uso terapêutico , Fadiga/etiologia , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos
3.
BMJ ; 366: l5221, 2019 09 18.
Artigo em Inglês | MEDLINE | ID: mdl-31533922

RESUMO

OBJECTIVE: To examine the design characteristics, risk of bias, and reporting adequacy of pivotal randomised controlled trials of cancer drugs approved by the European Medicines Agency (EMA). DESIGN: Cross sectional analysis. SETTING: European regulatory documents, clinical trial registry records, protocols, journal publications, and supplementary appendices. ELIGIBILITY CRITERIA: Pivotal randomised controlled trials of new cancer drugs approved by the EMA between 2014 and 2016. MAIN OUTCOME MEASURES: Study design characteristics (randomisation, comparators, and endpoints); risk of bias using the revised Cochrane tool (bias arising from the randomisation process, deviations from intended interventions, missing outcome data, measurement of the outcome, and selection of the reported result); and reporting adequacy (completeness and consistency of information in trial protocols, publications, supplementary appendices, clinical trial registry records, and regulatory documents). RESULTS: Between 2014 and 2016, the EMA approved 32 new cancer drugs on the basis of 54 pivotal studies. Of these, 41 (76%) were randomised controlled trials and 13 (24%) were either non-randomised studies or single arm studies. 39/41 randomised controlled trials had available publications and were included in our study. Only 10 randomised controlled trials (26%) measured overall survival as either a primary or coprimary endpoint, with the remaining trials evaluating surrogate measures such as progression free survival and response rates. Overall, 19 randomised controlled trials (49%) were judged to be at high risk of bias for their primary outcome. Concerns about missing outcome data (n=10) and measurement of the outcome (n=7) were the most common domains leading to high risk of bias judgments. Fewer randomised controlled trials that evaluated overall survival as the primary endpoint were at high risk of bias than those that evaluated surrogate efficacy endpoints (2/10 (20%) v 16/29 (55%), respectively). When information available in regulatory documents and the scientific literature was considered separately, overall risk of bias judgments differed for eight randomised controlled trials (21%), which reflects reporting inadequacies in both sources of information. Regulators identified additional deficits beyond the domains captured in risk of bias assessments for 10 drugs (31%). These deficits included magnitude of clinical benefit, inappropriate comparators, and non-preferred study endpoints, which were not disclosed as limitations in scientific publications. CONCLUSIONS: Most pivotal studies forming the basis of EMA approval of new cancer drugs between 2014 and 2016 were randomised controlled trials. However, almost half of these were judged to be at high risk of bias based on their design, conduct, or analysis, some of which might be unavoidable because of the complexity of cancer trials. Regulatory documents and the scientific literature had gaps in their reporting. Journal publications did not acknowledge the key limitations of the available evidence identified in regulatory documents.


Assuntos
Antineoplásicos/uso terapêutico , Aprovação de Drogas/métodos , Neoplasias/tratamento farmacológico , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Viés , Estudos Transversais , Controle de Medicamentos e Entorpecentes , Humanos , Projetos de Pesquisa , Relatório de Pesquisa
4.
Cochrane Database Syst Rev ; 8: CD012736, 2019 08 14.
Artigo em Inglês | MEDLINE | ID: mdl-31425624

RESUMO

BACKGROUND: Larviciding refers to the regular application of chemical or microbial insecticides to water bodies or water containers to kill the aquatic immature forms of the mosquito (the larvae and pupae). OBJECTIVES: To summarize research evidence evaluating whether larviciding with chemical or microbial insecticides prevents malaria transmission. SEARCH METHODS: We searched the Cochrane Infectious Diseases Group Specialized Register; the Cochrane Central Register of Controlled Trials (CENTRAL), published in the Cochrane Library; MEDLINE; Embase; CAB Abstracts; LILACS; the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP); ClinicalTrials.gov; and the ISRCTN registry up to 6 June 2019. SELECTION CRITERIA: We included cluster-randomized controlled trials (cRCTs), interrupted time series (ITS), randomized cross-over studies, non-randomized cross-over studies, and controlled before-and-after studies (CBAs) that compared larviciding with no larviciding. DATA COLLECTION AND ANALYSIS: We independently assessed trials for eligibility and risk of bias, and extracted data. We assessed the certainty of evidence using the GRADE approach. MAIN RESULTS: Four studies (one cRCT, two CBAs, and one non-randomized cross-over design) met the inclusion criteria. All used ground application of larvicides (people hand-delivering larvicides); one evaluated chemical and three evaluated microbial agents. Studies were carried out in The Gambia, Tanzania, Kenya, and Sri Lanka. Three studies were conducted in areas where mosquito aquatic habitats were less extensive (< 1 km²), and one where habitats were more extensive (> 1 km²; a cross-over study from The Gambia).For aquatic habitats of less than 1 km², one cRCT randomized eight villages in Sri Lanka to evaluate chemical larviciding using insect growth regulator; and two CBA studies undertaken in Kenya and Tanzania evaluated microbial larvicides. In the cRCT, larviciding across all villages was associated with lower malaria incidence (rate ratio 0.24, 4649 participants, low-certainty evidence) and parasite prevalence (risk ratio (RR) 0.26, 5897 participants, low-certainty evidence) compared to no larviciding. The two CBA studies reported lower malaria prevalence during the intervention period (parasite prevalence RR 0.79, 95% confidence interval (CI) 0.71 to 0.89; 70,902 participants; low-certainty evidence). The Kenyan study also reported a reduction in the incidence of new malaria cases (RR 0.62, 95% CI 0.38 to 1.01; 720 participants; very low-certainty evidence).For aquatic habitats of more than 1 km², the non-randomized cross-over trial using microbial larvicides did not detect an effect for malaria incidence (RR 1.58, 95% CI 0.94 to 2.65; 4226 participants), or parasite prevalence (RR 1.15, 95% CI 0.41 to 3.20; 3547 participants); both were very low-certainty evidence. The Gambia trial also reported the mean haemoglobin level, and there was no difference across the four comparisons (mean difference -0.13, 95% CI -0.40 to 0.13; 3586 participants).We were unable to summarize or pool entomological outcomes due to unreported and missing data. AUTHORS' CONCLUSIONS: Most controlled studies on larviciding have been performed with microbial agents. Ground larviciding for non-extensive larval habitats may have an effect on malaria transmission, and we do not know if there is an effect in large-scale aquatic habitats. We found no studies using larviciding application techniques that could cover large aquatic habitats, such as aerial spraying using aircraft.


Assuntos
Reservatórios de Doenças/parasitologia , Inseticidas/farmacologia , Malária/prevenção & controle , Controle de Mosquitos/métodos , Animais , Culicidae , Ecossistema , Humanos , Análise de Séries Temporais Interrompida , Larva/efeitos dos fármacos , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos
5.
Medicine (Baltimore) ; 98(27): e16199, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31277127

RESUMO

BACKGROUND: Clinical evidence indicates that women will benefit from regular physical activity during pregnancy. This study aimed to summarize and update the evidence on the effect of exercise on maternal gestational weight gain (GWG). METHODS: We conducted a systematic literature search of Pubmed, Embase, and Cochrane Library from inception until July, 2018 for randomized controlled trials (RCTs) that investigate the effect of physical exercises on the maternal GWG compared with that of no physical exercises or conventional medical care. We extracted data from eligible trials for study characteristics, interventions, patients' baseline characteristics and outcomes for the study populations of interest. We conducted meta-analyses using random effects models. RESULTS: From 844 citations, 23 RCTs including 4462 pregnant women met the inclusion criteria. Meta-analysis indicated that compared with that in women having conventional medical care, GWG was significantly decreased in pregnant women with physical exercise [weighted mean difference (WMD) -1.02, 95% CI -1.35 to -0.70; P < .01; I = 48.4%]. Women appeared to benefit more for gestational weight control for exercise frequency of 3 times per week (WMD -1.22, 95% CI -1.55 to -0.90; I = 40.3%) and exercise duration of 30 to 45 minutes each time (WMD -1.32, 95% CI -1.79 to -0.85; I = 1.5%). CONCLUSION: This meta-analysis provides indications that exercise intervention can reduce maternal GWG for pregnant women, especially for those with exercise frequency of 3 times per week and duration of 30 to 45 minutes each time.


Assuntos
Terapia por Exercício/métodos , Exercício/fisiologia , Ganho de Peso na Gestação/fisiologia , Sobrepeso/prevenção & controle , Complicações na Gravidez/prevenção & controle , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Feminino , Humanos , Sobrepeso/fisiopatologia , Gravidez , Complicações na Gravidez/fisiopatologia
6.
Medicine (Baltimore) ; 98(27): e16275, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31277154

RESUMO

BACKGROUND: Halitosis is the term used to define an unpleasant odor emanating from the mouth. However, no studies have evaluated the causes and treatment of halitosis in the population of older adults with denture. METHODS: A randomized, controlled trial is proposed. The patients will be divided into 2 groups: G1: older adults who wear complete dentures and will be treated with tongue scraper (n = 20); G2 older adults who wear complete dentures and will be treated with PDT (n = 20). If the halitosis persists, the participants will be submitted to hygiene procedures for the mucosa and dentures. The evaluation of halitosis will be made before and after treatments, with OralChroma. If the halitosis is solved, the participants will return after 1 week for an additional evaluation. Oral Health Impact Profile (OHIP-14) will be administered by a calibrated examiner on the day the patient history is taken (baseline) and 1 week after treatment for halitosis. DISCUSSION: This protocol will determine the effectiveness of photodynamic therapy regarding the reduction of halitosis in older adults with complete denture. TRIAL REGISTRATION: This protocol was registered in ClinicalTrial.gov, under number NCT03960983. It was first posted and last updated in May 23, 2019. https://clinicaltrials.gov/ct2/show/NCT03960983.


Assuntos
Prótese Total/efeitos adversos , Halitose/tratamento farmacológico , Fotoquimioterapia/métodos , Fármacos Fotossensibilizantes/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Idoso , Seguimentos , Humanos , Pessoa de Meia-Idade , Estudos Retrospectivos , Método Simples-Cego , Fatores de Tempo
7.
NeuroRehabilitation ; 44(4): 459-477, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31256086

RESUMO

BACKGROUND: Research mainly focuses on motor recovery of the upper limb after stroke. Less attention has been paid to somatosensory recovery. OBJECTIVE: To review and summarize the effect of upper limb somatosensory interventions on somatosensory impairment, motor impairment, functional activity and participation after stroke. METHODS: Biomedical databases Ovid Medline, EMBASE, Web of Science, PEDro, and OTseeker were searched with an update in May 2018. Randomized controlled trials investigating the effect of somatosensory-specific interventions focusing on exteroceptive, proprioceptive or higher cortical somatosensory dysfunction, or any combination were eligible for inclusion. Quality of included studies were assessed using Physiotherapy Evidence Database (PEDro) scale. Standardized Mean Differences and Mean Differences and 95% confidence intervals were calculated and combined in meta-analyses. RESULTS: Active somatosensory interventions did not show a significant effect on somatosensation and activity, but demonstrated a significant improvement in motor impairment (SMD = 0.73, 95% CI = 0.14 to 1.32). No study evaluating active somatosensory intervention included participation. Passive somatosensory interventions significantly improved light touch sensation (SMD = 1.13, 95% CI = 0.20 to 2.05). Passive somatosensory interventions did not show significant effects on proprioception and higher cortical somatosensation, motor impairment, activity and participation. CONCLUSIONS: To date, there is low quality evidence suggesting active somatosensory interventions having a beneficial effect on upper limb impairment and very low quality evidence suggesting passive somatosensory interventions improving upper limb light touch sensation. There is a need for further well-designed trials of somatosensory rehabilitation post stroke.


Assuntos
Atividade Motora/fisiologia , Recuperação de Função Fisiológica/fisiologia , Distúrbios Somatossensoriais/fisiopatologia , Reabilitação do Acidente Vascular Cerebral/métodos , Acidente Vascular Cerebral/fisiopatologia , Extremidade Superior/fisiopatologia , Atividades Cotidianas/psicologia , Humanos , Modalidades de Fisioterapia/tendências , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Distúrbios Somatossensoriais/reabilitação , Acidente Vascular Cerebral/psicologia , Acidente Vascular Cerebral/terapia , Resultado do Tratamento
9.
Medicine (Baltimore) ; 98(25): e16043, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31232938

RESUMO

BACKGROUND: Multiple sclerosis (MS) is a chronic immune mediated disease which affects the central nervous system (CNS), having a substantial financial, functional, and quality of life (QOL) impact on these people. The vitamin A supplementation has been studied as a therapeutic possibility for in MS. Therefore, the objective of this protocol is to build an outline for a future systematic review, which will provide up-to-date available evidence about the clinical impact of nutritional supplementation of vitamin A in the outcomes related to the symptoms in patients with this pathology. METHODS: The search will be performed in the following databases: PubMed, Embase, Scopus, cinahl, Scielo, Web of Science, the Cochrane Library and Science Direct, randomized clinical trials published until May 2019 that evaluate the relationship of the supplementation of vitamin A and health-related outcomes in patients with MS will be included. Preferred Reporting Items for Systematic review and Meta-Analysis Protocols (PRISMA-P) will be used to outline the protocol, and PRISMA to the systematic review. Undergraduate handbook of quality of evidence and strength of recommendations for decision making in health (GRADE) will be used to assess the quality of evidence and the strength of the recommendation, and the JADAD scale to assess the internal validity of selected studies. For the extraction of all the data found a database in Microsoft Excel will be created. For the summary of the findings the Cochrane Collaboration Handbook recommendations will be used, and for the meta-analysis standard statistical techniques the RevMan software will be used. RESULTS: In this study, we hope to find a considerable number of articles presenting evidence about the effectiveness of vitamin A supplementation in patients with MS. CONCLUSION: Currently, many lines of evidence have been produced when it comes to the use of food supplements. This systematic review proposal might provide recent, important, and trusted information for better treatment of patients. RECORD OF SYSTEMATIC REVIEW: This review was recorded in the International Register of Prospective Systematic Reviews (PROSPERO) on the January 30, 2019 (registration: CRD42019121757). Available at: http://www.crd.york.ac.uk/PROSPERO/display_record.php?ID=CRD42019121757.


Assuntos
Suplementos Nutricionais/normas , Metanálise como Assunto , Esclerose Múltipla/dietoterapia , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Literatura de Revisão como Assunto , Humanos , Terapia Nutricional/métodos , Avaliação de Resultados (Cuidados de Saúde)/métodos , Avaliação de Resultados (Cuidados de Saúde)/normas , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Vitamina A/uso terapêutico , Vitaminas/uso terapêutico
10.
BMC Public Health ; 19(1): 814, 2019 Jun 24.
Artigo em Inglês | MEDLINE | ID: mdl-31234825

RESUMO

BACKGROUND: Although gender is an important determinant of health behaviour with males less likely to perform health-protective behaviours, samples in health behaviour research are heavily biased towards females. This study investigated the use of online social network, Facebook, to reach and recruit inactive males to a team-based, social, and gamified physical activity randomised controlled trial. METHODS: Methodological techniques included a narrative literature review, survey of inactive males (n = 34) who rated advertisement images and text captions on scales of 1-10, and trial Facebook-delivered recruitment campaigns. Advertisement effectiveness was measured by cost-per-click to the study website, number of expressions of interest, and study enrolments from males. RESULTS: Survey results showed that vibrant images of men exercising accompanied by concise captions (< 35 words) were most effective. An advertising campaign incorporating these components achieved a cost-per-click of $0.60, with 80% of n = 50 expressions of interest being from men, a marked improvement from baseline campaigns in which only 11% of expressions of interest were from men. Despite this, men who were recruited through the targeted campaign failed to enrol into the study, primarily due to reluctance to invite friends to join their team. An alternative strategy of encouraging females to invite men boosted male participation from 18% of the sample at baseline to 29% in the targeted recruitment phase. CONCLUSIONS: Evidence-based approaches can improve Facebook recruitment outcomes, however, there are complex barriers hindering male recruitment to health behaviour studies that may necessitate multi-faceted strategies including involvement of family and friends.


Assuntos
Comportamentos Relacionados com a Saúde , Seleção de Pacientes , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Mídias Sociais/estatística & dados numéricos , Adolescente , Adulto , Humanos , Masculino , Inquéritos e Questionários , Adulto Jovem
11.
NeuroRehabilitation ; 44(3): 369-377, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31177237

RESUMO

INTRODUCTION: Although the role of trunk exercises in the chronic phase of stroke is acknowledged, the addition of specific inpatient training in the subacute stage is a matter of debate and varies among centers. Recent new evidence suggests the question should be revisited. OBJECTIVE: To assess the impact of the addition of specific trunk training to inpatient rehabilitation protocols after a recent stroke. METHODS: A systematic review was performed assessing the impact of inpatient trunk training. The search was performed in LILACS, SciELO, PEDro, Cochrane, and NCBI PubMed databases for clinical trials published up to December 31st, 2017. The initial bibliographic research identified 3202 articles. After analyzing the titles, 19 abstracts were selected for detailed analysis. After application of the eligibility criteria, the final selection included nine studies. Outcome measurements from the same evaluation instruments were submitted to a meta-analysis to improve homogeneity (7 studies). RESULTS: All patients in the included studies were recruited less than three months after a stroke. Seven studies assessed trunk control using the Trunk Impairment Scale (TIS). There was a significant improvement in trunk control with a pooled increase in TIS score of 3.3 points from the baseline (CI95:2.54-4.06, p < 0.0001). Three studies assessed balance using the Brunel Balance Assessment (BBA) scale. There was also a significant improvement in balance with a pooled increase in BBA score of 2.7 points (CI95:1.5-4.03, p < 0.0001). The Berg Balance Scale was used for balance assessment in three studies. The meta-analysis of their results showed a pooled increase of 13.2 points (CI95:9.49-16.84, p < 0.0001). Weight transfer was evaluated in four studies using different methods. The addition of inpatient trunk exercises was associated with an improvement in the ability to transfer the trunk laterally in three studies. CONCLUSION: The introduction of trunk-based inpatient training protocols brings short-term benefits in trunk performance and balance in stroke patients.


Assuntos
Terapia por Exercício/métodos , Hospitalização/tendências , Equilíbrio Postural/fisiologia , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Reabilitação do Acidente Vascular Cerebral/métodos , Acidente Vascular Cerebral/fisiopatologia , Atividades Cotidianas/psicologia , Peso Corporal/fisiologia , Feminino , Humanos , Masculino , Acidente Vascular Cerebral/psicologia , Acidente Vascular Cerebral/terapia , Reabilitação do Acidente Vascular Cerebral/psicologia , Tronco/fisiologia
14.
J Clin Neurosci ; 66: 209-219, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31085075

RESUMO

BACKGROUND: Traumatic brain injury (TBI) can causes numerous cognitive impairments usually in the aspects of problem-solving, executive function, memory, and attention. Several studies has suggested that rehabilitation treatment interventions can be effective in treating cognitive symptoms of brain injury. Virtual reality (VR) technology potential as a useful tool for the assessment and rehabilitation of cognitive processes. OBJECTIVES: The aims of present systematic review are to examine effects of VR training intervention on cognitive function, and to identify effective VR treatment protocol in patients with TBI. METHODS: PubMed, Scopus, PEDro, REHABDATA, EMBASE, web of science, and MEDLINE were searched for studies investigated effect of VR on cognitive functions post TBI. The methodological quality were evaluated using PEDro scale. The results of selected studies were summarized. RESULTS: Nine studies were included in present study. Four were randomized clinical trials, case studies (n = 3), prospective study (n = 1), and pilot study (n = 1). The scores on the PEDro ranged from 0 to 7 with a mean score of 3. The results showed improvement in various cognitive function aspects such as; memory, executive function, and attention in patients with TBI after VR training. CONCLUSION: Using different VR tools with following treatment protocol; 10-12 sessions, 20-40 min in duration with 2-4 sessions per week may improves cognitive function in patients with TBI. There was weak evidence for effects of VR training on attention post TBI.


Assuntos
Lesões Encefálicas Traumáticas/epidemiologia , Lesões Encefálicas Traumáticas/terapia , Transtornos Cognitivos/epidemiologia , Transtornos Cognitivos/terapia , Terapia Cognitivo-Comportamental/métodos , Terapia de Exposição à Realidade Virtual/métodos , Atenção/fisiologia , Lesões Encefálicas Traumáticas/psicologia , Cognição/fisiologia , Transtornos Cognitivos/psicologia , Função Executiva/fisiologia , Humanos , Memória/fisiologia , Projetos Piloto , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Resultado do Tratamento
16.
Cancer Treat Rev ; 76: 33-40, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31108240

RESUMO

Attribution of adverse events (AEs) is critical to oncology drug development and the regulatory process. However, processes for determining the causality of AEs are often sub-optimal, unreliable, and inefficient. Thus, we conducted a toxicity-attribution workshop in Silver Springs MD to develop guidance for improving attribution of AEs in oncology clinical trials. Attribution stakeholder experts from regulatory agencies, sponsors and contract research organizations, clinical trial principal investigators, pre-clinical translational scientists, and research staff involved in capturing attribution information participated. We also included patients treated in oncology clinical trials and academic researchers with expertise in attribution. We identified numerous challenges with AE attribution, including the non-informative nature of and burdens associated with the 5-tier system of attribution, increased complexity of trial logistics, costs and time associated with AE attribution data collection, lack of training in attribution for early-career investigators, insufficient baseline assessments, and lack of consistency in the reporting of treatment-related and treatment-emergent AEs in publications and clinical scientific reports. We developed recommendations to improve attribution: we propose transitioning from the present 5-tier system to a 2-3 tier system for attribution, more complete baseline information on patients' clinical status at trial entry, and mechanisms for more rapid sharing of AE information during trials. Oncology societies should develop recommendations and training in attribution of toxicities. We call for further harmonization and synchronization of recommendations regarding causality safety reporting between FDA, EMA and other regulatory agencies. Finally, we suggest that journals maintain or develop standardized requirements for reporting attribution in oncology clinical trials.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos , Antineoplásicos/efeitos adversos , Ensaios Clínicos Fase III como Assunto/métodos , Desenvolvimento de Medicamentos/métodos , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos
17.
J Orthop Surg Res ; 14(1): 97, 2019 Apr 10.
Artigo em Inglês | MEDLINE | ID: mdl-30971262

RESUMO

PURPOSE: Postoperative knee flexion protocol has been widely recognized as a highly attractive, simple, and cost-effective tactic to improve patient's outcomes after primary total knee arthroplasty (TKA). However, optimal knee position and duration of knee flexion are still controversial. The purpose of this meta-analysis was to compare the effectiveness of different postoperative knee flexion protocols, as an aid to find out optimal limb management strategy following TKA. METHODS: We conducted a meta-analysis to identify the available and relevant randomized controlled trials (RCTs) with regard to the influence of different postoperative knee positions on clinical outcomes after primary TKA in electronic databases, including PubMed, EMBASE, the Cochrane Library, Web of Science, CNKI, Wanfang Med Online, and VIP, up to May 2018. In this meta-analysis, three major subgroups based on diverse postoperative knee flexion protocols were considered: long-term (≥ 24 h) high flexion (> 30°), short term (< 24 h) high flexion (> 30°), and long-term (≥ 24 h) mild flexion (≤ 30°). The statistical analysis was performed using the Review Manager (RevMan) version 5.3 software. RESULTS: A total of 16 trials were finally included in this meta-analysis. The result of subgroup analysis indicated that keeping the knee in high flexion (> 30°) postoperatively for a long time (≥ 24 h) significantly reduced total blood loss (P < 0.00001), hidden blood loss (P < 0.00001), and transfusion requirements (P = 0.003) and led to a significant improvement in range of motion (ROM) at 1 week after operation (P < 0.00001); keeping the knee in high flexion (> 30°) postoperatively for a short time (< 24 h) significantly reduced total blood loss (P = 0.006) and hidden blood loss (P < 0.00001) but not significantly improved ROM at 1 week after operation (P = 0.34) and reduced transfusion requirements (P = 0.62); and keeping the knee in mild flexion (≤ 30°) postoperatively for a long time (≥ 24 h) significantly reduced total blood loss (P = 0.02) and transfusion requirements (P = 0.02) and improved ROM at 1 week after operation (P < 0.00001) but not significantly reduced hidden blood loss (P = 0.11). Furthermore, there was no significant difference with respect to the rates of wound-related infection and DVT between the three knee flexion subgroups. CONCLUSIONS: This meta-analysis showed that the long-term (≥ 24 h) high flexion (> 30°) protocol could be an optimal limb management to reduce blood loss and blood transfusion requirements and facilitate early postoperative rehabilitation exercises in patients after primary TKA without increasing in complication rate.


Assuntos
Artroplastia do Joelho/reabilitação , Posicionamento do Paciente/métodos , Cuidados Pós-Operatórios/métodos , Transfusão de Sangue/estatística & dados numéricos , Humanos , Articulação do Joelho/fisiopatologia , Hemorragia Pós-Operatória/prevenção & controle , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Amplitude de Movimento Articular
18.
Int J Surg ; 66: 37-47, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31022519

RESUMO

BACKGROUND: Although numerous treatments exist for fecal incontinence (FI), no consensus exists on the best treatment strategy. The aim was to review the literature and to compare the clinical outcomes and effectiveness of treatments available for FI. MATERIALS AND METHOD: A systematic literature review was performed, from inception to May 2018, of the following databases: MEDLINE, EMBASE, Science Citation Index Expanded, Cochrane Library. The search terms used were "faecal incontinence" and "treatment". Only randomized controlled trials (RCTs) comparing treatments for FI were considered. A Bayesian network meta-analysis was performed using the Markov chain Monte Carlo method. RESULT: Forty-seven RCTs were included comparing 37 treatments and reporting on 3748 participants. No treatment ranked best or worst with high probability for any outcome of interest. No significant difference was identified between treatments for frequency of FI per week, or in changing the resting pressure, maximum resting pressure, squeeze pressure, and maximum squeeze pressure. Radiofrequency resulted in more adverse events compared to placebo. Sacral nerve stimulation (SNS) and zinc-aluminium improved the fecal incontinence quality of life questionnaire (FIQL) lifestyle, coping, and embarrassment domains compared to placebo. Transcutaneous posterior tibial nerve stimulation (TPTNS) improved the FIQL embarrassment domain compared to placebo. Autologous myoblasts and zinc-aluminium improved the FIQL depression domain compared to placebo. SNS, artificial bowel sphincter (ABS), and zinc-aluminium significantly improved incontinence scores compared to placebo. Injection of non-animal stabilized hyaluronic acid/dextranomer (NASHA/Dx) resulted in more patients with ≥50% reduction in FI episodes compared to placebo. CONCLUSION: SNS, ABS, TPTNS, NASHA/Dx, zinc-aluminium, and autologous myoblasts resulted in isolated improvements in specific outcomes of interest. No difference was identified in incontinence episodes, no treatment ranked best persistently or persistently improved outcomes, and many included treatments did not significantly benefit patients compared to placebo. Large multicentre RCTs with long-term follow-up and standardized inclusion criteria and outcome measures are needed.


Assuntos
Incontinência Fecal/terapia , Teorema de Bayes , Dextranos/uso terapêutico , Terapia por Estimulação Elétrica/métodos , Incontinência Fecal/fisiopatologia , Humanos , Ácido Hialurônico/uso terapêutico , Meta-Análise em Rede , Avaliação de Resultados (Cuidados de Saúde) , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Nervo Tibial/fisiopatologia
19.
Int J Surg ; 66: 62-71, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31034987

RESUMO

OBJECTIVE: To compare the safety and efficacy of percutaneous nephrolithotripsy (PCNL) in supine versus prone position for patients with renal or upper ureteral calculi. METHODS: A systematic search of Pubmed, Embase and Cochrane Central Register of Controlled Trials was performed to identify all eligible studies. All included randomized controlled trials (RCTs) were evaluated based on the inclusion and exclusion criteria. After quality assessment and date extraction, a meta-analysis was performed using RevMan 5.3 software. RESULTS: A total of 15 RCTs with 1474 patients were included in our meta-analysis. Pooled data showed that PCNL in supine position could significantly reduce the operative time [weighted mean difference (WMD) -12.02, 95% confidence interval (CI) -20.49 to -3.54, p = 0.005] and rate of fever [risk ratio (RR) 0.67, 95% CI 0.46 to 0.97, p = 0.03] compared to prone position. In addition, no significant differences could be found between groups in stone-free rate (p = 0.31), hospital stay (p = 0.59) and rate of overall complications (p = 0.11), mainly including urinary leakage (p = 0.83), pleural effusion (p = 0.74) and blood transfusion (p = 0.58). CONCLUSIONS: The current study found comparable stone-free rate and significant lower rate of postoperative fever in supine PCNL compared with prone PCNL. PCNL in supine position could be a safe and efficient choice for patients with renal or upper ureteral calculi.


Assuntos
Cálculos Renais/cirurgia , Nefrostomia Percutânea/métodos , Posicionamento do Paciente/métodos , Cálculos Ureterais/cirurgia , Adulto , Febre/etiologia , Humanos , Tempo de Internação/estatística & dados numéricos , Nefrostomia Percutânea/efeitos adversos , Razão de Chances , Duração da Cirurgia , Complicações Pós-Operatórias , Decúbito Ventral , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Decúbito Dorsal , Resultado do Tratamento
20.
J Headache Pain ; 20(1): 37, 2019 Apr 17.
Artigo em Inglês | MEDLINE | ID: mdl-30995909

RESUMO

BACKGROUND: In the past decade, migraine research has identified novel drug targets. In this review, we discuss recent data on emerging anti-migraine therapies. MAIN BODY: The development of ditans, gepants and anti-calcitonin gene-related peptide monoclonal antibodies for the treatment of migraine is one of the greatest advances in the migraine field. Lasmiditan, rimegepant and ubrogepant will extend our therapeutic armamentarium for managing acute migraine attacks when triptans are not effective or contraindicated due to cardiovascular disorders. The monoclonal antibodies are migraine specific prophylactic drugs with high responder rates and favorable adverse event profiles. Furthermore, they offer convenient treatment regimens of 4- or 12-week intervals. CONCLUSION: Collectively, novel migraine therapies represent a major progress in migraine treatment and will undoubtedly transform headache medicine.


Assuntos
Analgésicos/uso terapêutico , Antagonistas do Receptor do Peptídeo Relacionado ao Gene de Calcitonina/uso terapêutico , Transtornos de Enxaqueca/tratamento farmacológico , Triptaminas/uso terapêutico , Analgésicos/química , Animais , Antagonistas do Receptor do Peptídeo Relacionado ao Gene de Calcitonina/química , Humanos , Transtornos de Enxaqueca/diagnóstico , Piridinas/química , Piridinas/uso terapêutico , Pirróis/química , Pirróis/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Triptaminas/química
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA