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.

Postmortem magnetic resonance imaging of the heart ex situ: development of technical protocols.

Postmortem MRI (PMMR) examinations are seldom performed in legal medicine due to long examination times, unfamiliarity with the technique, and high costs. Furthermore, it is difficult to obtain access to an MRI device used for patients in clinical settings to image an entire human body. An alternative is available: ex situ organ examination. To our knowledge, there is no standardized protocol that includes ex situ organ preparation and scanning parameters for postmortem MRI. Thus, our objective was to develop a standard procedure for ex situ heart PMMR examinations. We also tested the oily contrast agent Angiofil® commonly used for PMCT angiography, for its applicability in MRI. We worked with a 3 Tesla MRI device and 32-channel head coils. Twelve porcine hearts were used to test different materials to find the best way to prepare and place organs in the device and to test scanning parameters. For coronary MR angiography, we tested different mixtures of Angiofil® and different injection materials. In a second step, 17 human hearts were examined to test the procedure and its applicability to human organs. We established two standardized protocols: one for preparation of the heart and another for scanning parameters based on experience in clinical practice. The established protocols enabled a standardized technical procedure with comparable radiological images, allowing for easy radiological reading. The performance of coronary MR angiography enabled detailed coronary assessment and revealed the utility of Angiofil® as a contrast agent for PMMR. Our simple, reproducible method for performing heart examinations ex situ yields high quality images and visualization of the coronary arteries.

Viticultura de precisión: predicción de cosecha a partir de variables del cultivo e índices de vegetación

El presente trabajo muestra los resultados provisionales de un proyecto de viticultura de precisión, llevado a cabo entre la Universidad de Lleida y la empresa Codorníu, S.A., con el objeto de predecir el rendimiento, de forma localizada, de diferentes variedades de viña para la producción de vinos y cavas de calidad. Las variables de cultivo muestreadas de forma detallada han sido: número de yemas, número de brotes, número de racimos, peso de la poda, vigor del cultivo y cosecha del año anterior (2003). El vigor del cultivo se ha extraído de una imagen multiespectral Quickbird 2. Estas variables se han analizado en un modelo de regresión múltiple con la cosecha del año 2004 (variable dependiente), ofreciendo diferentes ajustes según la variedad considerada y variables incorporadas en el análisis.

Protocolo para la zonificación intraparcelaria de la viña para vendimia selectiva a partir de imágenes multiespectratrales

En este trabajo se presenta un protocolo para la zonificación intraparcelaria de la viña con la finalidad de vendimia selectiva. Se basa en la adquisición de una imagen multiespectral detallada en el momento del envero, a partir de la cual se obtiene el índice de vegetación de la diferencia normalizada (NDVI). Este índice se clasifica en áreas de vigor alto y bajo mediante un proceso de clasificación no supervisada (algoritmo ISODATA). Las zonas resultantes se generalizan y se transfieren al monitor de cosecha de una máquina vendimiadora para realizar la recolección selectiva. La uva recolectada según este protocolo en parcelas control ha mostrado diferenciación en cuanto a parámetros de calidad como el pH, la acidez total, el contenido de polifenoles y el color. La imagen multiespectral utilizada fue adquirida por el satélite Quickbird-2. Los datos de calidad de la uva fueron muestreados según una malla regular de 5 filas por 10 cepas, procediendo a un test estadístico de rangos múltiples para analizar la separación de medias de las variables analizadas en cada zona de NDVI.

Fruit size and quality of pineapples cv. Vitória in response to micronutrient doses and way of application and to soil covers

The objective of this study was to evaluate the effects of foundation and leaf fertilization with micronutrients on fruit size and quality of pineapple cv. Vitória under the environmental conditions of the Baixo Acaraú irrigated perimeter in Northern Ceará State, Brazil, under two covers (bagana and black plastic) of the sandy soil of low fertility. The experimental design was a randomized split blocks one with four levels of soil dressing and four levels of foliar fertilization, with five replications. Micronutrient soil dressing was studied as FTE-12 at doses of 0, 60, 120 and 180 kg ha-1. The four levels of foliar fertilization were: LF0 (without fertilizer), LF 1 (15 leaf fertilization, using the amount of 1158.75 g Fe ha-1, 844.65 g Mn ha-1, 391.5 g ha-1 Zn, 322.65 g ha-1 Cu and 216 g ha-1 B), LF2 (15 leaf fertilization, using twice the quantities of level LF1) and LF3 (15 leaf fertilization, using three times the amount of level LF1). At 13 months after planting the micropropagated plantlets was carried out the floral induction treatment and five months later the fruit harvest determining the following variables: fruit weight and median diameter, soluble solids content (SS) and titratable acidity (TA). Both fruit weight and diameter increased with increasing doses of micronutrients applied to the soil and to the leaves, of plants grown both on bagana soil cover and plastic mulch. On the other hand fruit pulp quality was little affected by the treatments studied. There were a small increase of SS contents for plants grown on bagana soil cover and a small decrease of titratable acidity for those grown on plastic mulch, in both cases just in response to micronutrient foliar application.

Growth, production and quality of pineapple in response to herbicide use

In pineapple fields, weed competition is exacerbated by the fact that the crop is small and has a very slow vegetative development. The objective of this study was to determine the effects of herbicides on growth, yield and quality of pineapple, cultivar 'Pérola'. The experimental design was in randomized blocks with four treatments and four replications. Treatments consisted of weeding by hoe and the herbicides diuron; fluazifop-p-butyl and atrazine + S-metolachlor applied in post-emergence. The characteristics evaluated monthly during the vegetative stage were stem diameter, D-leaf length, number of leaves, number of emitted leaves and percentage of natural floral induction. In the reproductive phase, evaluations were made of average fruit weight (g) with and without crown, fruits length and diameter, number of slip, slip-sucker and sucker type seedlings, determination of soluble solids and pH in the pulp. There was no effect of herbicide treatment on the vegetative growth characteristics. Stem diameter increased until 330 days after planting, showing a decrease after this period. The D-leaf grew over time in all treatments, although phytotoxicity symptoms were observed after the first application of herbicides. The traits evaluated on the reproductive phase showed no significant differences in response to treatments. Therefore, the use of diuron fluazifop-p-butyl and atrazine + S-metolachlor did not affect growth, yield and fruit quality of pineapple, cultivar 'Pérola'.

Procurement, Quality and Productivity Enhancements and Manufacturing Strategy Formulation Applying Product Life Cycle Method

The objective of the thesis was to create a framework that can be used to define a manufacturing strategy taking advantage of the product life cycle method, which enables PQP enhancements. The starting point was to study synkron implementation of cost leadership and differentiation strategies in different stages of the life cycles. It was soon observed that Porter’s strategies were too generic for the complex and dynamic environment where customer needs deviate market and product specifically. Therefore, the strategy formulation process is based on the Terry Hill’s order-winner and qualifier concepts. The manufacturing strategy formulation is initiated with the definition of order-winning and qualifying criteria. From these criteria there can be shaped product specific proposals for action and production site specific key manufacturing tasks that they need to answer in order to meet customers and markets needs. As a future research it is suggested that the process of capturing order-winners and qualifiers should be developed so that the process would be simple and streamlined at Wallac Oy. In addition, defined strategy process should be integrated to the PerkinElmer’s SGS process. SGS (Strategic Goal Setting) is one of the PerkinElmer’s core management processes. Full Text: Null

Detection of Clinically Significant Prostate Cancer Using Magnetic Resonance Imaging-Ultrasound Fusion Targeted Biopsy: A Systematic Review.

CONTEXT: The current standard for diagnosing prostate cancer in men at risk relies on a transrectal ultrasound-guided biopsy test that is blind to the location of the cancer. To increase the accuracy of this diagnostic pathway, a software-based magnetic resonance imaging-ultrasound (MRI-US) fusion targeted biopsy approach has been proposed. OBJECTIVE: Our main objective was to compare the detection rate of clinically significant prostate cancer with software-based MRI-US fusion targeted biopsy against standard biopsy. The two strategies were also compared in terms of detection of all cancers, sampling utility and efficiency, and rate of serious adverse events. The outcomes of different targeted approaches were also compared. EVIDENCE ACQUISITION: We performed a systematic review of PubMed/Medline, Embase (via Ovid), and Cochrane Review databases in December 2013 following the Preferred Reported Items for Systematic reviews and Meta-analysis statement. The risk of bias was evaluated using the Quality Assessment of Diagnostic Accuracy Studies-2 tool. EVIDENCE SYNTHESIS: Fourteen papers reporting the outcomes of 15 studies (n=2293; range: 13-582) were included. We found that MRI-US fusion targeted biopsies detect more clinically significant cancers (median: 33.3% vs 23.6%; range: 13.2-50% vs 4.8-52%) using fewer cores (median: 9.2 vs 37.1) compared with standard biopsy techniques, respectively. Some studies showed a lower detection rate of all cancer (median: 50.5% vs 43.4%; range: 23.7-82.1% vs 14.3-59%). MRI-US fusion targeted biopsy was able to detect some clinically significant cancers that would have been missed by using only standard biopsy (median: 9.1%; range: 5-16.2%). It was not possible to determine which of the two biopsy approaches led most to serious adverse events because standard and targeted biopsies were performed in the same session. Software-based MRI-US fusion targeted biopsy detected more clinically significant disease than visual targeted biopsy in the only study reporting on this outcome (20.3% vs 15.1%). CONCLUSIONS: Software-based MRI-US fusion targeted biopsy seems to detect more clinically significant cancers deploying fewer cores than standard biopsy. Because there was significant study heterogeneity in patient inclusion, definition of significant cancer, and the protocol used to conduct the standard biopsy, these findings need to be confirmed by further large multicentre validating studies. PATIENT SUMMARY: We compared the ability of standard biopsy to diagnose prostate cancer against a novel approach using software to overlay the images from magnetic resonance imaging and ultrasound to guide biopsies towards the suspicious areas of the prostate. We found consistent findings showing the superiority of this novel targeted approach, although further high-quality evidence is needed to change current practice.

Corporate Identity and Desired Image Elements as a Basis for Corporate Image Development, Case: Myllykoski Sales

Tutkimuksen päätavoitteena oli auttaa Myllykoski –ryhmää määrittämään, mistä tekijöistä ryhmän uuden myyntiorganisaation, Myllykoski Salesin, tulevaisuuden imagon tulisi koostua. Näin ollen tutkimus pyrki selvittämään Myllykoski –ryhmän yritysidentiteetin nykytilaa ja Myllykoski Salesin toivottuja imagotekijöitä, sekä vertaamaan niiden vastaavuutta. Lisäksi tutkimuksen tavoitteena oli tutkia Myllykoski –ryhmän nykyistä ja toivottua tulevaisuuden imagotilaa. Jotta imagonrakennusprosessi olisi menestyksekäs, rakennettavan imagon ja viestittävien imagotekijöiden tulisi perustua yritysidentiteetin todellisiin tekijöihin. Yritysidentiteetin voidaan määritellä olevan yhtäläinen sisäisten sidosryhmien muodostaman yritysmielikuvan kanssa ja näin ollen nykyinen yritysidentiteetti voidaan paljastaa tutkimalla henkilökunnan mielipiteitä työorganisaatiotaan kohtaan. Näin ollen käsiteltävä tutkimus suoritettiin tekemällä kaksi sähköpostikyselyä, jotka suunnattiin Myllykoski -ryhmän myynti- ja markkinointihenkilökunnalle. Tutkimusten vastausprosentit olivat 71,4 % (johto, 14 lähetettyä kyselyä) ja 51,9 % (muu henkilökunta, 108 lähetettyä kyselyä). Saatuja vastauksia analysoitiin sekä laadullisesti että määrällisesti. Saaduista vastauksista oli selvästi havaittavissa Myllykoski –ryhmän yritysidentiteetin nykytila, nykyinen ja toivottu imagotila, sekä Myllykoski Salesin toivotut imagotekijät. Verrattaessa toivottuja imagotekijöitä ryhmän yritysidentiteettiin havaittiin, että suurin osa halutuista imagotekijöistä vastasi ryhmän identiteetin nykytilan ominaisuuksia ja näin ollen kyseisiä tekijöitä voitaisiin huoletta viestiä rakennettaessa Myllykoski Salesin imagoa. Joidenkin toivottujen imagotekijöiden viestintää tulisi kuitenkin vakavasti harkita, jottei rakennettaisi epärealistista imagoa.

Integrating Financial Perspective to Quality Orientated Management System. Case: ALSTOM Finland Oy

Tutkimuksen päätavoitteena on tutkia taloudellisen näkökulman integroimista laatuajatteluun pohjautuvaan johtamisjärjestelmään esimerkkiyrityksessä. Johtamisjärjestelmän tulee tuottaa tietoa johdon strategiselle päätöksenteolle ja lisäksi täyttää laatujärjestelmän (ISO 9001:2000) asettamat vaatimukset. Tutkimuksen kohteena oleva työkalu on balanced scorecard (tasapainotettu tuloskortti). Työn tarkoituksena on ehdottaa balanced scorecard- talouden tunnuslukuja esimerkkiyritykselle. Tutkimuksen tavoitteisiin päästään empiiristä tutkimusta varten tehdyn teoreettisen viitekehyksen avulla. Empiiristä tutkimustietoa kerätään osallistuvan havainnoinnin, haastattelujen ja keskustelujen avulla. Tutkimusmenetelmänä on laadullinen case -tutkimus. Balanced scorecardin eri näkökulmille ehdotettiin tunnuslukuja empiirisen tutkimuksen pohjalta. Lisäksi talouden näkökulmaa tutkittiin tarkemmin. Tutkimuksen johtopäätöksenä esitettiin, että taloudelliset tunnusluvut mittaavat ensisijaisesti strategiaa eivätkä laatua. Lisäksi huomioitiin, että tuloskorttien tulisi olla koekäytössä ennen bonuspalkkauksen ja balanced scorecardin yhdistämistä.

Etelä-Karjala asuin- ja elinympäristönä: Korkeasti koulutettujen nuorten näkökulma

Tämän tutkimuksen keskeisenä tarkoituksena on tutkia Etelä-karjalaa asuin- ja työpaikkana. Tutkimuksen päätavoitteena on selvittää asuin- ja elinympäristön laadun merkitystä alueella viihtymiseen. Tutkimus luokitellaan kaupunkitutkimukseksi, jossa tarkastelun kohteena on asuin- ja elinympäristön laatu. Tutkimuksessa hyödynnetään survey-tutkimusmenetelmää. Tutkimuksen teoriaoosassa tarkastellaan globalisaation alueellisia vaikutuksia, alueiden kilpailukyvyn ja kilpailuedun muodostumista sekä alueen imagon merkitystä kilpailussa. Tutkimukseen liittyvä tutkimusaineisto kerättiin kirjekyselyllä Lappeenrannan teknillisestä yliopistosta vuosina 1997-2000 valmistuneiden diblomi-insinöörien ja kauppatieteiden maistereiden keskuudesta. Tutkimuksen empiirisessä osassa mitataan tekijöitä, jotka vaikuttavat asuinpaikkakunnan valintaan. Lisäksi mitataan Etelä-Karjalan asuin- ja elinympäristön laatua. Aineiston perusteella voidaan todeta, että Etelä-Karjalan asuin- ja elinympäristön laadun fyysiset, toiminnalliset ja sosiaaliset ominaisuudet edesaauttavat yliopistoststa valmistuneita jäämään alueelle. Ongelmatekijäksi nousi alueen kyky tarjota korkeasti koulutetuille nuorille työpaikkoja

Defining ecologically relevant water quality targets for lakes in Europe

1. The implementation of the Water Framework Directive requires EU member states to establish and harmonize ecological status class boundaries for biological quality elements. In this paper, we describe an approach for defining ecological class boundaries that delineates shifts in lake ecosystem functioning and, therefore, provides ecologically meaningful targets for water policy in Europe. 2. We collected an extensive data set of 810 lake-years from nine Central European countries, and we used phytoplankton chlorophyll a, a metric widely used to measure the impact of eutrophication in lakes. Our approach establishes chlorophyll a target values in relation to three significant ecological effects of eutrophication: the decline of aquatic macrophytes, the dominance of potentially harmful cyanobacteria and the major functional switch from a clear water to a turbid state. 3. Ranges of threshold chlorophyll a concentrations are given for the two most common lake types in lowland Central Europe: for moderately deep lakes (mean depth 3–15 m), the greatest ecological shifts occur in the range 10–12 lg L 1 chlorophyll a, and for shallow lakes (<3 m mean depth), in the range 21–23 lg L 1 chlorophyll a. 4. Synthesis and applications. Our study provides class boundaries for determining the ecological status of lakes, which have robust ecological consequences for lake functioning and which, therefore, provide strong and objective targets for sustainable water management in Europe. The results have been endorsed by all participant member states and adopted in the European Commission legislation, marking the first attempt in international water policy to move from physico-chemical quality standards to harmonized ecologically based quality targets.

Quality of Disease Management and Risk of Mortality in English Primary Care Practices

OBJECTIVE: To investigate whether better management of chronic conditions by family practices reduces mortality risk. DATA: Two random samples of 5 million patients registered with over 8,000 English family practices followed up for 4 years (2004/5-2007/8). Measures of the quality of disease management for 10 conditions were constructed for each family practice for each year. The outcome measure was an indicator taking the value 1 if the patient died during a specified year, 0 otherwise. STUDY DESIGN: Cross-section and multilevel panel data multiple logistic regressions were estimated. Covariates included age, gender, morbidity, hospitalizations, attributed socio-economic characteristics, and local health care supply measures. PRINCIPAL FINDINGS: Although a composite measure of the quality of disease management for all 10 conditions was significantly associated with lower mortality, only the quality of stroke care was significant when all 10 quality measures were entered in the regression. CONCLUSIONS: The panel data results suggest that a 1 percent improvement in the quality of stroke care could reduce the annual number of deaths in England by 782 [95 percent CI: 423, 1140]. A longer study period may be necessary to detect any mortality impact of better management of other conditions.

Describing and Analyzing Information Technology through Total Quality Management and Process Management: Case Stora Enso Newsprint

Laatu on osaltaan vahvistamassa asemaansa liike-elämässä yritysten kilpaillessa kansainvälisillä markkinoilla niin hinnalla kuin laadulla. Tämä suuntaus on synnyttänyt useita laatuohjelmia, joita käytetään ahkerasti yritysten kokonais- valtaisen laatujohtamisen (TQM) toteuttamisessa. Laatujohtaminen kattaa yrityksen kaikki toiminnot ja luo vaatimuksia myös yrityksen tukitoimintojen kehittämiselle ja parantamiselle. Näihin lukeutuu myös tämän tutkimuksen kohde tietohallinto (IT). Tutkielman tavoitteena oli kuvata IT prosessin nykytila. Tutkielmassa laadittu prosessikuvaus pohjautuu prosessijohtamisen teoriaan ja kohdeyrityksen käyttämään laatupalkinto kriteeristöön. Tutkimusmenetelmänä prosessin nykytilan selvittämiseksi käytettiin teemahaastattelutta. Prosessin nykytilan ja sille asetettujen vaatimusten selvittämiseksi haastateltiin IT prosessin asiakkaita. Prosessianalyysi, tärkeimpien ala-prosessien tunnistaminen ja parannusalueiden löytäminen ovat tämän tutkielman keskeisemmät tulokset. Tutkielma painottui IT prosessin heikkouksien ja parannuskohteiden etsimiseen jatkuvan kehittämisen pohjaksi, ei niinkään prosessin radikaaliin uudistamiseen. Tutkielmassa esitellään TQM:n periaatteet, laatutyökaluja sekä prosessijohtamisen terminologia, periaatteet ja sen systemaattinen toteutus. Työ antaa myös kuvan siitä, miten TQM ja prosessijohtaminen niveltyvät yrityksen laatutyössä.

Domains of importance to the quality of life of older people from two Swiss regions

BACKGROUND: quality of life (QoL) is a subjective perception whose components may vary in importance between individuals. Little is known about which domains of QoL older people deem most important. OBJECTIVE: this study investigated in community-dwelling older people the relationships between the importance given to domains defining their QoL and socioeconomic, demographic and health status. METHODS: data were compiled from older people enrolled in the Lc65+ cohort study and two additional, population-based, stratified random samples (n = 5,300). Principal components analysis (PCA) was used to determine the underlying domains among 28 items that participants defined as important to their QoL. The components extracted were used as dependent variables in multiple linear regression models to explore their associations with socioeconomic, demographic and health status. RESULTS: PCA identified seven domains that older persons considered important to their QoL. In order of importance (highest to lowest): feeling of safety, health and mobility, autonomy, close entourage, material resources, esteem and recognition, and social and cultural life. A total of six and five domains of importance were significantly associated with education and depressive symptoms, respectively. The importance of material resources was significantly associated with a good financial situation (β = 0.16, P = 0.011), as was close entourage with living with others (β = 0.20, P = 0.007) and as was health and mobility with age (β = -0.16, P = 0.014). CONCLUSION: the importance older people give to domains of their QoL appears strongly related to their actual resources and experienced losses. These findings may help clinicians, researchers and policy makers better adapt strategies to individuals' needs.