Reporting of methodologic information on trial registries for quality assessment: a study of trial records retrieved from the WHO search portal

Background: Although randomized clinical trials (RCTs) are considered the gold standard of evidence, their reporting is often suboptimal. Trial registries have the potential to contribute important methodologic information for critical appraisal of study results. Methods and Findings: The objective of the study was to evaluate the reporting of key methodologic study characteristics in trial registries. We identified a random sample (n = 265) of actively recruiting RCTs using the World Health Organization International Clinical Trials Registry Platform (ICTRP) search portal in 2008. We assessed the reporting of relevant domains from the Cochrane Collaboration’s ‘Risk of bias’ tool and other key methodological aspects. Our primary outcomes were the proportion of registry records with adequate reporting of random sequence generation, allocation concealment, blinding, and trial outcomes. Two reviewers independently assessed each record. Weighted overall proportions in the ICTRP search portal for adequate reporting of sequence generation, allocation concealment, blinding (including and excluding open label RCT) and primary outcomes were 5.7% (95% CI 3.0–8.4%), 1.4% (0–2.8%), 41% (35–47%), 8.4% (4.1–13%), and 66% (60–72%), respectively. The proportion of adequately reported RCTs was higher for registries that used specific methodological fields for describing methods of randomization and allocation concealment compared to registries that did not. Concerning other key methodological aspects, weighted overall proportions of RCTs with adequately reported items were as follows: eligibility criteria (81%), secondary outcomes (46%), harm (5%) follow-up duration (62%), description of the interventions (53%) and sample size calculation (1%). Conclusions: Trial registries currently contain limited methodologic information about registered RCTs. In order to permit adequate critical appraisal of trial results reported in journals and registries, trial registries should consider requesting details on key RCT methods to complement journal publications. Full protocols remain the most comprehensive source of methodologic information and should be made publicly available.

Discriminating crop, weeds and soil surface with a terrestrial LIDAR sensor

In this study, the evaluation of the accuracy and performance of a light detection and ranging (LIDAR) sensor for vegetation using distance and reflection measurements aiming to detect and discriminate maize plants and weeds from soil surface was done. The study continues a previous work carried out in a maize field in Spain with a LIDAR sensor using exclusively one index, the height profile. The current system uses a combination of the two mentioned indexes. The experiment was carried out in a maize field at growth stage 12–14, at 16 different locations selected to represent the widest possible density of three weeds: Echinochloa crus-galli (L.) P.Beauv., Lamium purpureum L., Galium aparine L.and Veronica persica Poir.. A terrestrial LIDAR sensor was mounted on a tripod pointing to the inter-row area, with its horizontal axis and the field of view pointing vertically downwards to the ground, scanning a vertical plane with the potential presence of vegetation. Immediately after the LIDAR data acquisition (distances and reflection measurements), actual heights of plants were estimated using an appropriate methodology. For that purpose, digital images were taken of each sampled area. Data showed a high correlation between LIDAR measured height and actual plant heights (R2 = 0.75). Binary logistic regression between weed presence/absence and the sensor readings (LIDAR height and reflection values) was used to validate the accuracy of the sensor. This permitted the discrimination of vegetation from the ground with an accuracy of up to 95%. In addition, a Canonical Discrimination Analysis (CDA) was able to discriminate mostly between soil and vegetation and, to a far lesser extent, between crop and weeds. The studied methodology arises as a good system for weed detection, which in combination with other principles, such as vision-based technologies, could improve the efficiency and accuracy of herbicide spraying.

Clinical trial designs for rare diseases: studies developed and discussed by the International Rare Cancers Initiative.

BACKGROUND: The past three decades have seen rapid improvements in the diagnosis and treatment of most cancers and the most important contributor has been research. Progress in rare cancers has been slower, not least because of the challenges of undertaking research. SETTINGS: The International Rare Cancers Initiative (IRCI) is a partnership which aims to stimulate and facilitate the development of international clinical trials for patients with rare cancers. It is focused on interventional--usually randomized--clinical trials with the clear goal of improving outcomes for patients. The key challenges are organisational and methodological. A multi-disciplinary workshop to review the methods used in ICRI portfolio trials was held in Amsterdam in September 2013. Other as-yet unrealised methods were also discussed. RESULTS: The IRCI trials are each presented to exemplify possible approaches to designing credible trials in rare cancers. Researchers may consider these for use in future trials and understand the choices made for each design. INTERPRETATION: Trials can be designed using a wide array of possibilities. There is no 'one size fits all' solution. In order to make progress in the rare diseases, decisions to change practice will have to be based on less direct evidence from clinical trials than in more common diseases.

Characterising strengths, weakness, opportunities and threats in producing naked oat as a novel crop for northern growing conditions

Selostus: Paljasjyväinen kaura uutena viljelykasvina Suomen kasvuoloissa

Statistical Reviewers Improve Reporting in Biomedical Articles: a Randomized Trial.

Background. Although peer review is widely considered to be the most credible way of selecting manuscripts and improving the quality of accepted papers in scientific journals, there is little evidence to support its use. Our aim was to estimate the effects on manuscript quality of either adding a statistical peer reviewer or suggesting the use of checklists such as CONSORT or STARD to clinical reviewers or both. Methodology and Principal Findings. Interventions were defined as 1) the addition of a statistical reviewer to the clinical peer review process, and 2) suggesting reporting guidelines to reviewers; with"no statistical expert" and"no checklist" as controls. The two interventions were crossed in a 262 balanced factorial design including original research articles consecutively selected, between May 2004 and March 2005, by the Medicina Clinica (Barc) editorial committee. We randomized manuscripts to minimize differences in terms of baseline quality and type of study (intervention, longitudinal, cross-sectional, others). Sample-size calculations indicated that 100 papers provide an 80% power to test a 55% standardized difference. We specified the main outcome as the increment in quality of papers as measured on the Goodman Scale. Two blinded evaluators rated the quality of manuscripts at initial submission and final post peer review version. Of the 327 manuscripts submitted to the journal, 131 were accepted for further review, and 129 were randomized. Of those, 14 that were lost to follow-up showed no differences in initial quality to the followed-up papers. Hence, 115 were included in the main analysis, with 16 rejected for publication after peer review. 21 (18.3%) of the 115 included papers were interventions, 46 (40.0%) were longitudinal designs, 28 (24.3%) cross-sectional and 20 (17.4%) others. The 16 (13.9%) rejected papers had a significantly lower initial score on the overall Goodman scale than accepted papers (difference 15.0, 95% CI: 4.6- 24.4). The effect of suggesting a guideline to the reviewers had no effect on change in overall quality as measured by the Goodman scale (0.9, 95% CI: 20.3+2.1). The estimated effect of adding a statistical reviewer was 5.5 (95% CI: 4.3-6.7), showing a significant improvement in quality. Conclusions and Significance. This prospective randomized study shows the positive effect of adding a statistical reviewer to the field-expert peers in improving manuscript quality. We did not find a statistically significant positive effect by suggesting reviewers use reporting guidelines.

The REporting of Studies Conducted Using Observational Routinely-Collected Health Data (RECORD) Statement: Methods for Arriving at Consensus and Developing Reporting Guidelines.

OBJECTIVE: Routinely collected health data, collected for administrative and clinical purposes, without specific a priori research questions, are increasingly used for observational, comparative effectiveness, health services research, and clinical trials. The rapid evolution and availability of routinely collected data for research has brought to light specific issues not addressed by existing reporting guidelines. The aim of the present project was to determine the priorities of stakeholders in order to guide the development of the REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statement. METHODS: Two modified electronic Delphi surveys were sent to stakeholders. The first determined themes deemed important to include in the RECORD statement, and was analyzed using qualitative methods. The second determined quantitative prioritization of the themes based on categorization of manuscript headings. The surveys were followed by a meeting of RECORD working committee, and re-engagement with stakeholders via an online commentary period. RESULTS: The qualitative survey (76 responses of 123 surveys sent) generated 10 overarching themes and 13 themes derived from existing STROBE categories. Highest-rated overall items for inclusion were: Disease/exposure identification algorithms; Characteristics of the population included in databases; and Characteristics of the data. In the quantitative survey (71 responses of 135 sent), the importance assigned to each of the compiled themes varied depending on the manuscript section to which they were assigned. Following the working committee meeting, online ranking by stakeholders provided feedback and resulted in revision of the final checklist. CONCLUSIONS: The RECORD statement incorporated the suggestions provided by a large, diverse group of stakeholders to create a reporting checklist specific to observational research using routinely collected health data. Our findings point to unique aspects of studies conducted with routinely collected health data and the perceived need for better reporting of methodological issues.

Medication incidents in primary care medicine: protocol of a study by the Swiss Federal Sentinel Reporting System.

BACKGROUND/RATIONALE: Patient safety is a major concern in healthcare systems worldwide. Although most safety research has been conducted in the inpatient setting, evidence indicates that medical errors and adverse events are a threat to patients in the primary care setting as well. Since information about the frequency and outcomes of safety incidents in primary care is required, the goals of this study are to describe the type, frequency, seasonal and regional distribution of medication incidents in primary care in Switzerland and to elucidate possible risk factors for medication incidents. Label="METHODS AND ANALYSIS" ="METHODS"/> <AbstractText STUDY DESIGN AND SETTING: We will conduct a prospective surveillance study to identify cases of medication incidents among primary care patients in Switzerland over the course of the year 2015. PARTICIPANTS: Patients undergoing drug treatment by 167 general practitioners or paediatricians reporting to the Swiss Federal Sentinel Reporting System. INCLUSION CRITERIA: Any erroneous event, as defined by the physician, related to the medication process and interfering with normal treatment course. EXCLUSION CRITERIA: Lack of treatment effect, adverse drug reactions or drug-drug or drug-disease interactions without detectable treatment error. PRIMARY OUTCOME: Medication incidents. RISK FACTORS: Age, gender, polymedication, morbidity, care dependency, hospitalisation. STATISTICAL ANALYSIS: Descriptive statistics to assess type, frequency, seasonal and regional distribution of medication incidents and logistic regression to assess their association with potential risk factors. Estimated sample size: 500 medication incidents. LIMITATIONS: We will take into account under-reporting and selective reporting among others as potential sources of bias or imprecision when interpreting the results. ETHICS AND DISSEMINATION: No formal request was necessary because of fully anonymised data. The results will be published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT0229537.

Under-reporting of dietary energy intake in five populations of the African diaspora.

Studies on the role of diet in the development of chronic diseases often rely on self-report surveys of dietary intake. Unfortunately, many validity studies have demonstrated that self-reported dietary intake is subject to systematic under-reporting, although the vast majority of such studies have been conducted in industrialised countries. The aim of the present study was to investigate whether or not systematic reporting error exists among the individuals of African ancestry (n 324) in five countries distributed across the Human Development Index (HDI) scale, a UN statistic devised to rank countries on non-income factors plus economic indicators. Using two 24 h dietary recalls to assess energy intake and the doubly labelled water method to assess total energy expenditure, we calculated the difference between these two values ((self-report - expenditure/expenditure) × 100) to identify under-reporting of habitual energy intake in selected communities in Ghana, South Africa, Seychelles, Jamaica and the USA. Under-reporting of habitual energy intake was observed in all the five countries. The South African cohort exhibited the highest mean under-reporting ( - 52·1% of energy) compared with the cohorts of Ghana ( - 22·5%), Jamaica ( - 17·9%), Seychelles ( - 25·0%) and the USA ( - 18·5%). BMI was the most consistent predictor of under-reporting compared with other predictors. In conclusion, there is substantial under-reporting of dietary energy intake in populations across the whole range of the HDI, and this systematic reporting error increases according to the BMI of an individual.

Reporting for account and sales management

Tutkimuksen tavoitteena oli kerätä Elcoteq Network Oyj:n myyntihenkilöiden tietotarpeet ja konkretisoida ne raportoinnin kautta. Tutkimus keskittyi asiakasvirran eri vaiheissa tarvittavaan asiakas- ja projektikohtaiseen tietoon. Tarkoituksena oli parantaa raportointia vastaamaan asiakkaan ja sales case:n hallintaa alkaen asiakasvirran uusasiakasvaiheesta ja projektin arvioinnista. Tietotarpeet kerättiin haastattelujen avulla ja osallistumalla aiheeseen liittyviin projekteihin. Haastattelujen ja teorian avulla projektiliiketoiminnan avainpiirteet ja asiakaskannattavuuteen vaikuttavat tekijät kerättiin yhteen ja muutettiin konkretiaksi raportoinnin parannusehdotuksien kautta. Tutkimus osoitti, että myyntihenkilöiden näkökulmasta olisi muodostettava uudet raportit tukemaan asiakkaan ja projektin hallintaa. Ennustettu voidaan verrata toteutuneeseen ja sekä asikkuuden, että sales case:n seuranta paranee uusien raporttien avulla. Budjetit, sekä asiakaskohtaiset tavoitteet voidaan laatia luotettavimmin ja kokonaiskuva asiakkuuden ja projektin kannattavuudesta pystytään näkemään ko. raporteista sekä graafein, että numeerisena tietona.

Corruption scandals, press reporting, and accountability. Evidence from Spanish mayors.

[spa] En este trabajo se analiza con datos de España los efectos de la corrupción local sobre los resultados electorales. En base a las noticias publicadas entre 1996 y 2009, se construye una nueva base de datos que recoge los casos de corrupción y noticias relativas a cambios en los planes urbanísticos que no han seguido el procedimiento legal. La base de datos muestra que los primeros escándalos de corrupción urbanística surgieron durante el mandato electoral de 1999-2003, pero que éstos alcanzaron sus niveles máximos justo antes de las elecciones de 2007. Se estima una ecuación del porcentaje de voto obtenido por el partido en el poder en estas elecciones locales y se encuentra que la pérdida media de voto después de un caso de corrupción se sitúa alrededor del 4%. Este efecto es más elevado (del 9%) si el caso de corrupción ha recibido una amplia cobertura por los diarios. Los efectos estimados para las elecciones de 2003 son significativamente inferiores. Cuando se consideran los casos en que los políticos han tenido cargas judiciales por corrupción y amplia cobertura por los diarios, la pérdida de voto asciende hasta el 12%. No obstante, la cobertura por los diarios genera un efecto negativo en el voto incluso cuando no hay cargas judiciales.

The effects of inter-crop cultivation Between rows of citrus crop on spreading of Guignardia citricarpa Ascospores and in the citrus black spot occurrence

This study highlighted the effect of planting coast-cross grass and forage peanut cv. Amarilis between rows of Natal oranges on spreading of Guignardia citricarpa ascospores and consequent citrus black spot control. Treatments evaluated were: 1- conventional cultivation, free of fungicides; 2- conventional cultivation, using protective fungicides; 3- inter-crop cultivation of coast-cross grass between rows of citrus crops and; 4- inter-cropping cultivation of forage peanut between the rows of citrus crops. Quest Volumetric Spore SystemTM traps were set in order to determine the number of ascospores released. A total of 33 inspections were conducted weekly, from the end of August until early September the following year. A diagrammatic scale was used to determine the severity of the disease as well as the percentage of fruits having a commercial standard. The coast-cross grass was more effective in reducing the number of ascospores produced, whose average statistics were lower than in the conventional treatments, free-fungicides. The inter-crop and conventional cultivation method coupled with fungicide treatment was more effective in reducing the severity of citrus black spot symptoms, and differs statistically from the fungicide-free control method. These methods also resulted in a higher percentage of fruits of a commercial standard, ranging from the 89% through the 91% percentile, and the cultivation, free of fungicides, fell within the 73%.

Corruption scandals, press reporting, and accountability. Evidence from Spanish mayors.

[spa] En este trabajo se analiza con datos de España los efectos de la corrupción local sobre los resultados electorales. En base a las noticias publicadas entre 1996 y 2009, se construye una nueva base de datos que recoge los casos de corrupción y noticias relativas a cambios en los planes urbanísticos que no han seguido el procedimiento legal. La base de datos muestra que los primeros escándalos de corrupción urbanística surgieron durante el mandato electoral de 1999-2003, pero que éstos alcanzaron sus niveles máximos justo antes de las elecciones de 2007. Se estima una ecuación del porcentaje de voto obtenido por el partido en el poder en estas elecciones locales y se encuentra que la pérdida media de voto después de un caso de corrupción se sitúa alrededor del 4%. Este efecto es más elevado (del 9%) si el caso de corrupción ha recibido una amplia cobertura por los diarios. Los efectos estimados para las elecciones de 2003 son significativamente inferiores. Cuando se consideran los casos en que los políticos han tenido cargas judiciales por corrupción y amplia cobertura por los diarios, la pérdida de voto asciende hasta el 12%. No obstante, la cobertura por los diarios genera un efecto negativo en el voto incluso cuando no hay cargas judiciales.

Water consumption and soil moisture distribution in melon crop with mulching and in a protected environment

Mulching has become an important technique for land cover, but there are some technical procedures which should be adjusted for these new modified conditions to establish optimum total water depth. It is also important to observe the soil-water relations as soil water distribution and wetted volume dimensions. The objective of the present study was to estimate melon evapotranspiration under mulching in a protected environment and to verify the water spatial distribution around the melon root system in two soil classes. Mulching provided 27 mm water saving by reducing water evaporation. In terms of volume each plant received, on average, the amount of 175.2 L of water in 84 days of cultivation without mulching, while when was used mulching the water requirement was 160.2 L per plant. The use of mulching reduced the soil moisture variability throughout the crop cycle and allowed a greater distribution of soil water that was more intense in the clay soil. The clayey soil provided on average 43 mm more water depth retention in 0.50 m soil deep relative to the sandy loam soil, and reduced 5.6 mm the crop cycle soil moisture variation compared to sandy loam soil.

Development of Managerial Reporting for a Pulp and Paper Technology Supplier

Työn tavoitteena oli yritysjohdon käyttämän sisäisen raportin kehittäminen vastaamaan paremmin johdon tarpeita. Teoriaosuuden tarkoituksena oli selvittää kirjallisuuden avulla sisäisen raportin käyttöä johdon työkaluna, hyvän raportin vaatimuksia ja yleisiä raportoinnin periaatteita. Empiirinen osuus toteutettiin haastatteluiden avulla ja analysoimalla case-yrityksen sisäisiä raportteja. Empiirisen osan tavoitteena oli selvittää aiemman raportin ongelmat, löytää ratkaisut näihin ongelmiin ja laatia uusi raportointimalli, joka palvelee paremmin raportin käyttäjiä.Teoriaosuuden perusteella voidaan päätellä, että raportoinnin kehittämiseen vaikuttaa eniten raportin käyttötarkoitus ja henkilöt, joiden työväline raportti tulee olemaan. Raportin kehittäminen on jatkuva prosessi, sillä raportin tulee mukautua liiketoiminta- ja organisaatiomuutoksiin.Työn empiirisessä osassa esitetty uusi raportointimalli palvelee case-yritystä monella eri tasolla. Se tukee johdon työskentelyä ja tarjoaa yritystasolla välineen kustannusten parempaan hallintaan ja seurantaan.