The statistical significance of randomized controlled trial results is frequently fragile: A case for a Fragility Index

Objectives

A P-value <0.05 is one metric used to evaluate the results of a randomized controlled trial (RCT). We wondered how often statistically significant results in RCTs may be lost with small changes in the numbers of outcomes.

Study Design and Setting

A review of RCTs in high-impact medical journals that reported a statistically significant result for at least one dichotomous or time-to-event outcome in the abstract. In the group with the smallest number of events, we changed the status of patients without an event to an event until the P-value exceeded 0.05. We labeled this number the Fragility Index; smaller numbers indicated a more fragile result.

Results

The 399 eligible trials had a median sample size of 682 patients (range: 15-112,604) and a median of 112 events (range: 8-5,142); 53% reported a P-value <0.01. The median Fragility Index was 8 (range: 0-109); 25% had a Fragility Index of 3 or less. In 53% of trials, the Fragility Index was less than the number of patients lost to follow-up.

Conclusion

The statistically significant results of many RCTs hinge on small numbers of events. The Fragility Index complements the P-value and helps identify less robust results. 

Industrial scale microwave processing of tomato juice using a novel continuous microwave system

This study evaluated the effect of an industrial scale continuous flow microwave volumetric heating system in comparison to conventional commercial scale pasteurisation for the processing of tomato juice in terms of physicochemical properties, microbial characteristics and antioxidant capacity. The effect against oxidative stress in Caco-2 cells, after in vitro digestion was also investigated. Physicochemical and colour characteristics of juices were very similar between technologies and during storage. Both conventional and microwave pasteurisation inactivated microorganisms and kept them in low levels throughout storage. ABTS⁺ values, but not ORAC, were higher for the microwave pasteurised juice at day 0 however no significant differences between juices were observed during storage. Juice processed with the microwave system showed an increased cytoprotective effect against H₂O₂ induced oxidation in Caco-2 cells. Organoleptic analysis revealed that the two tomato juices were very similar. The continuous microwave volumetric heating system appears to be a viable alternative to conventional pasteurisation.

Novel system for distant assessment of cataract surgical quality in rural China

BACKGROUND: This study aims to assess the quality of various steps of manual small incision cataract surgery and predictors of quality, using video recordings.
DESIGN: This paper applies a retrospective study.
PARTICIPANTS: Fifty-two trainees participated in a hands-on small incision cataract surgery training programme at rural Chinese hospitals.
METHODS: Trainees provided one video each recorded by a tripod-mounted digital recorder after completing a one-week theoretical course and hands-on training monitored by expert trainers. Videos were graded by two different experts, using a 4-point scale developed by the International Council of Ophthalmology for each of 12 surgical steps and six global factors. Grades ranged from 2 (worst) to 5 (best), with a score of 0 if the step was performed by trainers.
MAIN OUTCOME MEASURES: Mean score for the performance of each cataract surgical step rated by trainers.
RESULTS: Videos and data were available for 49/52 trainees (94.2%, median age 38 years, 16.3% women and 77.5% completing > 50 training cases). The majority (53.1%, 26/49) had performed ≤ 50 cataract surgeries prior to training. Kappa was 0.57∼0.98 for the steps (mean 0.85). Poorest-rated steps were draping the surgical field (mean ± standard deviation = 3.27 ± 0.78), hydro-dissection (3.88 ± 1.22) and wound closure (3.92 ± 1.03), and top-rated steps were insertion of viscoelastic (4.96 ± 0.20) and anterior chamber entry (4.69 ± 0.74). In linear regression models, higher total score was associated with younger age (P = 0.015) and having performed >50 independent manual small incision cases (P = 0.039).
CONCLUSIONS: More training should be given to preoperative draping, which is poorly performed and crucial in preventing infection. Surgical experience improves ratings.© 2015 Royal Australian and New Zealand College of Ophthalmologists.

Advanced monitoring of South Portugal water bodies towards WFD

The challenge on implementation of the EU Water Framework Directive (WFD) fosters the development of new monitoring methods and approaches. It is now commonly accepted that the use of classical monitoring campaigns in discrete point is not sufficient to fully assess and describe a water body. Due to this the WFD promote the use of modelling techniques in surface waters to assist all phases of the process, from characterisation and establishment of reference conditions to identification of pressures and assessment of impact. The work presented in this communication is based on these principles. A classical monitoring of the water status of the main transitional water bodies of Algarve (south of Portugal) is combined with advanced in situ water profiling and hydrodynamic, water quality and ecological modelling of the systems to build a complete description of its state. This approach extends spatially and temporally the resolution of the classical point sampling. The methodology was applied during a 12 month program in Ria Formosa coastal lagoon, the Guadiana estuary and the Arade estuary. The synoptic profiling uses an YSI 6600 EDS multi-parameter system attached to a boat and a GPS receiver to produce monthly synoptic maps of the systems. This data extends the discrete point sampling with laboratory analysis performed monthly in several points of each water body. The point sampling is used to calibrate the profiling system and to include variables, such as nutrients, not measured by the sensors. A total of 1427 samplings were performed for physical and chemical parameters, chlorophyll and microbiologic contamination in the water column. This data is used to drive the hydrodynamic, transport and ecological modules of the MOHID water modelling system (www.mohid.com), enabling an integrate description of the water column.

Modelação da qualidade microbiológica da água na Ria Formosa

Este estudo integra-se numa avaliação hidrodinâmica e monitorização microbiológica da qualidade da água da Ria Formosa. A monitorização foi implementada pela DRAOT Algarve com a colaboração da EST, da FCMA e do IST. A metodologia utilizada consiste na aplicação de um modelo matemático para simulação das variáveis hidrodinâmicas e da qualidade da água. Utilizam-se como traçadores os coliformes fecais (CF), considerados indicadores de contaminação fecal pelo Dec-Lei 236/98 de 1 de Agosto, relativo à qualidade de águas do litoral e salobras para fins aquícolas- águas conquícolas. As águas da ria são usadas para cultura de diversas espécies conquícolas de bivalves. Estes são organismos que filtram e retêm no seu interior material particulado existente em suspensão na água tais como os CF entre outros microorganismos presentes na água. Para avaliar a concentração de coliformes nos bivalves e gastrópodes foi desenvolvido um modelo que simula a bioacumulação desta propriedade por parte do bivalve. Da sua aplicação permite classificar a Ria em várias classes conforme o estabelecido no Dec. Lei nº 293/98 de 18 de Setembro.

Qualidade da água na Ria Formosa: combinando técnicas de amostragem e de modelação para uma gestão integrada das águas residuais

Aplica-se uma técnica combinada de amostragem clássica, perfilagem in situ com sonda multiparamétrica e modelação matemática para avaliar a qualidade da água da Ria Formosa como meio receptor dos efluentes das ETAR’s. O sistema de modelação desenvolvido baseia-se num modelo hidrodinâmico que resolve as equações de águas pouco profundas pelo método dos volumes finitos acoplado a um modelo de transporte Lagrangiano para a simulação das plumas microbiológicas. Este sistema é usado como ferramenta de gestão para ensaiar diferentes cenários de descarga com variação da localização do ponto de descarga, analisando o impacto das alternativas no meio receptor.

Ante-projecto de uma unidade de tratamento de águas residuais oleosas, no porto de Cádis

Dissertação de mest., Engenharia do Ambiente, Faculdade de Ciências do Mar e do Ambiente, Universidade do Algarve, 2008

A avifauna como meio de valorização turística da Ria Formosa - Faro

Dissertação mest., Biologia Marinha, Universidade do Algarve, 2009

Avaliação de desempenho de estações de tratamento de água para consumo humano

Tese de dout., Ciências e Tecnologias do Ambiente, Faculdade de Ciências e Tecnologia, Universidade do Algarve, 2009

Diminuição do pico de cheia na rede de drenagem de águas pluviais através do sistema de aproveitamento de água da chuva

Dissertação de mest., Engenharia de Recursos Hídricos, Faculdade de Ciências e Tecnologia, Univ. do Algarve, 2010

Evolução dos compostos nos lixiviados dos aterros sanitários do barlavento e sotavento algarvio

Dissertação de mest., Engenharia do Ambiente (Tecnologias Ambientais), Faculdade de Ciências e Tecnologia, Univ. do Algarve, 2011

Metodologia de avaliação de desempenho regional da sustentabilidade ambiental de instalações de tratamento, transporte e armazenamento de águas para consumo humano

Dissertação de mest., Recursos Hídricos, Faculdade de Ciências e Tecnologia, Univ. do Algarve, 2011

Activated carbon adsorption of cyanotoxins from natural waters

Tese de dout., Ciências e Tecnologias do Ambiente (Tecnologias do Ambiente), Faculdade de Ciências e Tecnologia, Univ. do Algarve, 2010

Supplier's position in project marketing networks

The present study explores relationships between project marketers and their customers in project marketing context. The purpose of the study is to increase the understanding on supplier’s position in project marketing networks. Project marketing is representing a high volume in the international business, and the industrial network approach and the project marketing research cannot fully explain a supplier’s position in project marketing networks. Increased knowledge on project networks can also contribute to industrial marketing research more generally. Data for the present study was collected firstly during the pilot case study from project buyers in the paper and the steel industry in interviews. Secondly an entire project marketing case concerning a steel industry case was used as a data source. The data included interviews, correspondence between the supplier and the buyer, and project documents. The data of the pilot case was analysed with contents analysis, and in the case a deeper analysis based on the developed Stage Dimension framework was used. Supplier’s position in project marketing networks is a hierarchical and dynamic concept including a supplier’s position on the highest level. The dimensions of the position concept are the intermediate level, and the dimensions are based on the underlying components. Supplier’s position is composed from four organization related dimensions, and two individual actor related dimensions. The composition of the supplier’s position varies during the project marketing process, and consequently the relative importance of the dimensions is changing over the process. Supplier’s position in project marketing networks is shaped by incremental and radical changes. Radical changes are initiated by critical events. The study contributes to the research of industrial networks and project marketing. The theoretical contribution of the study is threefold: firstly it proposes a structure of the position concept in project marketing networks, secondly it proposes the Position Stage Dimension Component (PSDC) model for the development of supplier’s position during the project marketing process, and thirdly the study widens the critical event concept to cover the project marketing process both on the organizational and individual level. In addition to the theoretical contributions there are several managerial implications for planning and implementing marketing strategies in the project context.