A Delphi Process to Optimize Quality and Performance of Drug Evaluation in Neonates

Background: Neonatal trials remain difficult to conduct for several reasons: in particular the need for study sites to have an existing infrastructure in place, with trained investigators and validated quality procedures to ensure good clinical, laboratory practices and a respect for high ethical standards. The objective of this work was to identify the major criteria considered necessary for selecting neonatal intensive care units that are able to perform drug evaluations competently. Methodology and Main Findings: This Delphi process was conducted with an international multidisciplinary panel of 25 experts from 13 countries, selected to be part of two committees (a scientific committee and an expert committee), in order to validate criteria required to perform drug evaluation in neonates. Eighty six items were initially selected and classified under 7 headings: "NICUs description - Level of care'' (21), "Ability to perform drug trials: NICU organization and processes (15), "Research Experience'' (12), "Scientific competencies and area of expertise'' (8), "Quality Management'' (16), "Training and educational capacity'' (8) and "Public involvement'' (6). Sixty-one items were retained and headings were rearranged after the first round, 34 were selected after the second round. A third round was required to validate 13 additional items. The final set includes 47 items divided under 5 headings. Conclusion: A set of 47 relevant criteria will help to NICUs that want to implement, conduct or participate in drug trials within a neonatal network identify important issues to be aware of. Summary Points: 1) Neonatal trials remain difficult to conduct for several reasons: in particular the need for study sites to have an existing infrastructure in place, with trained investigators and validated quality procedures to ensure good clinical, laboratory practices and a respect for high ethical standards. 2) The present Delphi study was conducted with an international multidisciplinary panel of 25 experts from 13 countries and aims to identify the major criteria considered necessary for selecting neonatal intensive care units (NICUs) that are able to perform drug evaluations competently. 3) Of the 86 items initially selected and classified under 7 headings - "NICUs description - Level of care'' (21), "Ability to perform drug trials: NICU organization and processes (15), "Research Experience'' (12), "Scientific competencies and area of expertise'' (8), "Quality Management'' (16), "Training and educational capacity'' (8) and "Public involvement'' (6) - 47 items were selected following a three rounds Delphi process. 4) The present consensus will help NICUs to implement, conduct or participate in drug trials within a neonatal network.

Studies on the egg quality of Penaeus monodon Fabricius based on morphology and hatching rates

Eggs of P. monodon are classified into 5 different types on the basis of morphological criteria and hatching rates: A sub(1) eggs, which undergo normal development with 58% hatching rate; A sub(2) eggs, which show delayed and/or abnormal development with 32% hatching rate; B eggs, which are unfertilized and characterized by irregular cytoplasmic formation; C eggs, which are unfertilized and show no change in appearance; and D eggs, which are unfertilized and show extensive bacterial presence. The establishment of a highly linear relationship between percent A sub(1) eggs and hatching rate provides a useful tool to aid the hatchery technician in determining which spawnings to reject outright and which to rear through the larval and post-larval stages.

Adoption of recommended quality control practices by fish processing factories

Responses to mailed questionnaires from 31 fish processing factories revealed that for 55 recommended practices in quality control, the percentage of adopters varied from 21.43 to 100.The adoption index was not correlated to any of five variables studied. The mean adoption index did not differ significantly between five other criteria related to fish processing. Rate of rejection or reprocessing at the factory itself was highly correlated with the amount of water used per tonne of processed material.

Improving data quality in DSM modelling: A structural comparison approach

The Dependency Structure Matrix (DSM) has proved to be a useful tool for system structure elicitation and analysis. However, as with any modelling approach, the insights gained from analysis are limited by the quality and correctness of input information. This paper explores how the quality of data in a DSM can be enhanced by elicitation methods which include comparison of information acquired from different perspectives and levels of abstraction. The approach is based on comparison of dependencies according to their structural importance. It is illustrated through two case studies: creation of a DSM showing the spatial connections between elements in a product, and a DSM capturing information flows in an organisation. We conclude that considering structural criteria can lead to improved data quality in DSM models, although further research is required to fully explore the benefits and limitations of our proposed approach.

Detecting air pockets for architectural concrete quality assessment using visual sensing

Air pockets, one kind of concrete surface defects, are often created on formed concrete surfaces during concrete construction. Their existence undermines the desired appearance and visual uniformity of architectural concrete. Therefore, measuring the impact of air pockets on the concrete surface in the form of air pockets is vital in assessing the quality of architectural concrete. Traditionally, such measurements are mainly based on in-situ manual inspections, the results of which are subjective and heavily dependent on the inspectors’ own criteria and experience. Often, inspectors may make different assessments even when inspecting the same concrete surface. In addition, the need for experienced inspectors costs owners or general contractors more in inspection fees. To alleviate these problems, this paper presents a methodology that can measure air pockets quantitatively and automatically. In order to achieve this goal, a high contrast, scaled image of a concrete surface is acquired from a fixed distance range and then a spot filter is used to accurately detect air pockets with the help of an image pyramid. The properties of air pockets (the number, the size, and the occupation area of air pockets) are subsequently calculated. These properties are used to quantify the impact of air pockets on the architectural concrete surface. The methodology is implemented in a C++ based prototype and tested on a database of concrete surface images. Comparisons with manual tests validated its measuring accuracy. As a result, the methodology presented in this paper can increase the reliability of concrete surface quality assessment

Coupling model uncertainty for coupled rainfall/runoff and surface water quality models in river problems

Coupled hydrology and water quality models are an important tool today, used in the understanding and management of surface water and watershed areas. Such problems are generally subject to substantial uncertainty in parameters, process understanding, and data. Component models, drawing on different data, concepts, and structures, are affected differently by each of these uncertain elements. This paper proposes a framework wherein the response of component models to their respective uncertain elements can be quantified and assessed, using a hydrological model and water quality model as two exemplars. The resulting assessments can be used to identify model coupling strategies that permit more appropriate use and calibration of individual models, and a better overall coupled model response. One key finding was that an approximate balance of water quality and hydrological model responses can be obtained using both the QUAL2E and Mike11 water quality models. The balance point, however, does not support a particularly narrow surface response (or stringent calibration criteria) with respect to the water quality calibration data, at least in the case examined here. Additionally, it is clear from the results presented that the structural source of uncertainty is at least as significant as parameter-based uncertainties in areal models. © 2012 John Wiley & Sons, Ltd.

The Development of a Holistic and Quantitative Tool for the Assessment and Improvement of Survey Quality.

There are a variety of guidelines and methods available to measure and assess survey quality. Most of these are based on qualitative descriptions. In practice, they are not easy to implement and it is very difficult to make comparisons between surveys. Hence there is a theoretical and pragmatic demand to develop a mainly quantitative based survey assessment tool. This research aimed to meet this need and make contributions to the evaluation and improvement of survey quality. Acknowledging the critical importance of measurement issues in survey research, this thesis starts with a comprehensive introduction to measurement theory and identifies the types of measurement errors associated with measurement procedures through three experiments. Then it moves on to describe concepts, guidelines and methods available for measuring and assessing survey quality. Combining these with measurement principles leads to the development of a quantitative based statistical holistic tool to measure and assess survey quality. The criteria, weights and subweights for the assessment tool are determined using Multi-Criteria Decision-Making (MCDM) and a survey questionnaire based on the Delphi method. Finally the model is applied to a database of surveys which was constructed to develop methods of classification, assessment and improvement of survey quality. The model developed in this thesis enables survey researchers and/or commissioners to make a holistic assessment of the value of the particular survey(s). This model is an Excel based audit which takes a holistic approach, following all stages of the survey from inception, to design, construction, execution, analysis and dissemination. At each stage a set of criteria are applied to assess quality. Scores attained against these assessments are weighted by the importance of the criteria and summed to give an overall assessment of the stage. The total score for a survey can be obtained by a combination of the scores for every stage weighted again by the importance of each stage. The advantage of this is to construct a means of survey assessment which can be used in a diagnostic manner to assess and improve survey quality.

Health-Related Quality of Life for individuals with hepatitis C: A narrative review.

BACKGROUND The assessment of Health-Related Quality of Life (HRQoL) in hepatitis C (HCV) infected individuals continues to gain importance. However, rarely do reviews of this literature consider quantitative and qualitative accounts of HRQoL collectively, which only allows partial insight into the topic. This narrative review aims to address this gap in the literature. METHODS Literature searches were conducted using seven databases with two separate search strategies, and results assessed for eligibility using specific inclusion/exclusion criteria; a data extraction sheet was used to identify the dominant themes for each research paradigm which were then distilled to key findings to construct the narrative. RESULTS Quantitative investigation reveals a low HRQoL in individuals with HCV due to a complex multifactorial cause. During treatment for HCV, a further transient reduction is observed, followed by improvement if a sustained virological response is achieved. Qualitative data provide a recognisable voice to the everyday challenges experienced by individuals with HCV including insights into diagnosis and stigmatisation, contextualising how a reduced HRQoL is experienced day-to-day. Methodological limitations of these findings are then discussed. Much of the quantitative data has little relevance to current substance users as they are excluded from most trials, and appraisal of the qualitative literature reveals a marked difference in the lived experience of HCV infected current substance users and that of other HCV groups. CONCLUSION Concurrent analysis of quantitative and qualitative paradigms provides a deeper understanding of the true burden of HCV illness on HRQoL. Greater utilisation of qualitative research within international clinical guidelines is likely to be of benefit in identifying relevant HRQoL outcomes for substance users.

Cancer associated malnutrition: prevalence of cachexia, sarcopenia and impact on treatment outcomes, survival and health related quality of life

Malnutrition, sarcopenia and cancer cachexia (CC) are prevalent among cancer patients and can have detrimental effects on clinical outcomes such as quality of life (QoL) and overall survival. Cachexia is associated with lower tolerance for chemotherapy, which limits the total dose that can be delivered, the number of symptomatic responses and any survival advantage that might be accrued. Moreover, for the majority who do not respond, cachexia may be exacerbated by systemic chemotherapy, thus increasing the net symptom burden experienced by patients. The multitude of interactions between cancer location, treatments, nutritional status and QoL has never been thoroughly explored in an Irish cancer cohort. The objectives of this thesis were to further understand nutritional status, especially body composition in ambulatory cancer patients and determine the relationship between nutritional status using different assessment criteria and QoL, chemotherapy toxicity and survival among cancer patients undergoing chemotherapy. Results aimed to identify baseline factors that may be predictive of poor outcome, toxicities to chemotherapy and disease-free and overall survival. This thesis broadly divides into two sections. The first section (Chapters 3 & 4) focuses on improving our knowledge of the nutritional status of Irish cancer outpatients using a cross sectional study design. A study of 517 patients referred for chemotherapy was conducted using computed tomography (CT) imaging (body composition) and a survey that documented oncologic data, weight loss (WL) data and QoL data. We revealed that a significant proportion of Irish cancer patients undergoing chemotherapy experience unintentional WL over the previous 6 months (62%), sarcopenia (45%) and CC (43%), and the distribution of WL and nutritional risk were associated with site of primary tumour and treatment intent. Patients that had sarcopenia, nutritional risk, or CC had significantly reduced functional abilities, more symptoms and adverse global QoL. In the second section of this thesis (Chapters 5 & 6) the potential link between developing toxicity to antineoplastic regimens in patients with sarcopenia was conducted by way of retrospective studies. A retrospective serial CT analysis defined the prevalence of sarcopenia in patients with metastatic renal cell carcinoma (mRCC) and metastatic castrate resistant prostate cancer (mCRPC), which was then correlated with dose limiting toxicities of sunitinib and docetaxel respectively. Sarcopenia was prevalent in patients with mRCC and mCRPC, was an occult condition in patients with normal/high BMI, was associated with less treatment days, was a significant predictor of DLT in patients receiving sunitinib and a significant predictor of neutropenia and neurosensory toxicities in patients receiving docetaxel. This thesis attempted to address the underlying research deficiencies in Irish oncology nutritional data at national level. The findings from this thesis have implications for the planning of cancer care interventions and indicate that further research is required to improve nutritional screening, in particular for CC and sarcopenia, in the hope that timely intervention can improve both patient-centered and oncologic outcomes.

Evaluation of the quality of the management of cancer of the corpus uteri-Selection of relevant quality indicators and implementation in Belgium

Objective Describe the methodology and selection of quality indicators (QI) to be implemented in the EFFECT (EFFectiveness of Endometrial Cancer Treatment) project. EFFECT aims to monitor the variability in Quality of Care (QoC) of uterine cancer in Belgium, to compare the effectiveness of different treatment strategies to improve the QoC and to check the internal validity of the QI to validate the impact of process indicators on outcome. Methods A QI list was retrieved from literature, recent guidelines and QI databases. The Belgian Healthcare Knowledge Center methodology was used for the selection process and involved an expert's panel rating the QI on 4 criteria. The resulting scores and further discussion resulted in a final QI list. An online EFFECT module was developed by the Belgian Cancer Registry including the list of variables required for measuring the QI. Three test phases were performed to evaluate the relevance, feasibility and understanding of the variables and to test the compatibility of the dataset. Results 138 QI were considered for further discussion and 82 QI were eligible for rating. Based on the rating scores and consensus among the expert's panel, 41 QI were considered measurable and relevant. Testing of the data collection enabled optimization of the content and the user-friendliness of the dataset and online module. Conclusions This first Belgian initiative for monitoring the QoC of uterine cancer indicates that the previously used QI selection methodology is reproducible for uterine cancer. The QI list could be applied by other research groups for comparison. © 2013 Elsevier Inc.

A uniform, quality controlled Surface Ocean CO2 Atlas (SOCAT)

A well documented, publicly available, global data set of surface ocean carbon dioxide (CO2) parameters has been called for by international groups for nearly two decades. The Surface Ocean CO2 Atlas (SOCAT) project was initiated by the international marine carbon science community in 2007 with the aim of providing a comprehensive, publicly available, regularly updated, global data set of marine surface CO2, which had been subject to quality control (QC). Many additional CO2 data, not yet made public via the Carbon Dioxide Information Analysis Center (CDIAC), were retrieved from data originators, public websites and other data centres. All data were put in a uniform format following a strict protocol. Quality control was carried out according to clearly defined criteria. Regional specialists performed the quality control, using state-of-the-art web-based tools, specially developed for accomplishing this global team effort. SOCAT version 1.5 was made public in September 2011 and holds 6.3 million quality controlled surface CO2 data points from the global oceans and coastal seas, spanning four decades (1968–2007). Three types of data products are available: individual cruise files, a merged complete data set and gridded products. With the rapid expansion of marine CO2 data collection and the importance of quantifying net global oceanic CO2 uptake and its changes, sustained data synthesis and data access are priorities.

A uniform, quality controlled Surface Ocean CO2 Atlas (SOCAT)

A well-documented, publicly available, global data set of surface ocean carbon dioxide (CO2) parameters has been called for by international groups for nearly two decades. The Surface Ocean CO2 Atlas (SOCAT) project was initiated by the international marine carbon science community in 2007 with the aim of providing a comprehensive, publicly available, regularly updated, global data set of marine surface CO2, which had been subject to quality control (QC). Many additional CO2 data, not yet made public via the Carbon Dioxide Information Analysis Center (CDIAC), were retrieved from data originators, public websites and other data centres. All data were put in a uniform format following a strict protocol. Quality control was carried out according to clearly defined criteria. Regional specialists performed the quality control, using state-of-the-art web-based tools, specially developed for accomplishing this global team effort. SOCAT version 1.5 was made public in September 2011 and holds 6.3 million quality controlled surface CO2 data points from the global oceans and coastal seas, spanning four decades (1968–2007). Three types of data products are available: individual cruise files, a merged complete data set and gridded products. With the rapid expansion of marine CO2 data collection and the importance of quantifying net global oceanic CO2 uptake and its changes, sustained data synthesis and data access are priorities.

The Philosophy and Practice of Interpretivist Research in Entrepreneurship Quality, Validation, and Trust

Knowledge production in entrepreneurship requires inclusivity as well as diversity and pluralism in research perspectives and approaches. In this article, the authors address concerns about interpretivist research regarding validity, reliability, objectivity, generalizability, and communicability of results that militate against its more widespread acceptance. Following the nonfoundationalist argument that all observation is theory-laden, context specific, and that there are no external criteria against which to assess research design and execution and the data produced, the authors propose that quality must be internalized within the underlying research philosophy rather than something to be tested upon completion. This requires a shift from the notion of validity as an outcome to validation as a process. To elucidate this, they provide a guiding framework and present a case illustration that will assist an interpretivist entrepreneurship researcher to establish and demonstrate the quality of their work.

Assessing quality of life in cardiac rehabilitation: Choosing an appropriate tool

Quality of life is an important outcome for people undergoing cardiac rehabilitation. This paper discusses the difficulties with defining the concept of quality of life and how it might be distinct from the concept of health-related quality of life. Based on a review of the literature, a description is provided of health-related quality of life questionnaires that have been used in cardiac rehabilitation populations. Some criteria for choosing between these questionnaires are then discussed and, finally, a brief discussion is presented of the concept of response shift and how this might influence the assessment of health-related quality of life in a cardiac rehabilitation setting.

Effect of preventive primary care outreach on health related quality of life among older adults at risk of functional decline: Randomised controlled trial

Objective: To evaluate the impact of a provider initiated primary care outreach intervention compared with usual care among older adults at risk of functional decline. Design: Randomised controlled trial. Setting: Patients enrolled with 35 family physicians in five primary care networks in Hamilton, Ontario, Canada. Participants Patients: were eligible if they were 75 years of age or older and were not receiving home care services. Of 3166 potentially eligible patients, 2662 (84%) completed the validated postal questionnaire used to determine risk of functional decline. Of 1724 patients who met the risk criteria, 769 (45%) agreed to participate and 719 were randomised. Intervention: The 12 month intervention, provided by experienced home care nurses in 2004-6, consisted of a comprehensive initial assessment using the resident assessment instrument for home care; collaborative care planning with patients, their families, and family physicians; health promotion; and referral to community health and social support services. Main outcome measures: Quality adjusted life years (QALYs), use and costs of health and social services, functional status, self rated health, and mortality. Results: The mean difference in QALYs between intervention and control patients during the study period was not statistically significant (0.017, 95% confidence interval -0.022 to 0.056; P=0.388). The mean difference in overall cost of prescription drugs and services between the intervention and control groups was not statistically significant, (-$C165 (£107; €118; $162), 95% confidence interval -$C16 545 to $C16 214; P=0.984). Changes over 12 months in functional status and self rated health were not significantly different between the intervention and control groups. Ten patients died in each group. Conclusions: The results of this study do not support adoption of this preventive primary care intervention for this target population of high risk older adults. Trial registration: Clinical trials NCT00134836.