The clinical nurse specialist in an Irish hospital.

PubMed

Wickham, Sheelagh

2011-01-01

This study was set in an acute Irish health care setting and aimed to explore the activity of the clinical nurse specialist (CNS) in this setting. Quantitative methodology, using a valid and reliable questionnaire, provided descriptive statistics that gave accurate data on the total population of CNSs in the health care setting. The study was set in an acute-care 750-bed hospital that had 25 CNSs in practice. The sample consisted of all 25 CNSs who are the total population of CNSs working in the acute health care institution. The findings show the CNS to be active in the roles of researcher, educator, communicator, change agent, leader, and clinical specialist, but the level of activity varies between different roles. There is variety in the activity of CNSs in the various roles and to what extent they enact the role. The findings merit further study on CNS role activity and possible variables that influence role activity.

Efficacy of exercise therapy in workers with rotator cuff tendinopathy: a systematic review

PubMed Central

Desmeules, François; Boudreault, Jennifer; Dionne, Clermont E.; Frémont, Pierre; Lowry, Véronique; MacDermid, Joy C.; Roy, Jean-Sébastien

2016-01-01

Objective: To perform a systematic review of randomized controlled trials (RCTs) on the efficacy of therapeutic exercises for workers suffering from rotator cuff (RC) tendinopathy. Methods: A literature search in four bibliographical databases (Pubmed, CINAHL, EMBASE, and PEDro) was conducted from inception up to February 2015. RCTs were included if participants were workers suffering from RC tendinopathy, the outcome measures included work-related outcomes, and at least one of the interventions under study included exercises. The methodological quality of the studies was evaluated with the Cochrane Risk of Bias Assessment tool. Results: The mean methodological score of the ten included studies was 54.4%±17.2%. Types of workers included were often not defined, and work-related outcome measures were heterogeneous and often not validated. Three RCTs of moderate methodological quality concluded that exercises were superior to a placebo or no intervention in terms of function and return-to-work outcomes. No significant difference was found between surgery and exercises based on the results of two studies of low to moderate methodological quality. One study of low methodological quality, comparing a workplace-based exercise program focusing on the participants' work demands to an exercise program delivered in a clinical setting, concluded that the work-based intervention was superior in terms of function and return-to-work outcomes. Conclusion: There is low to moderate-grade evidence that therapeutic exercises provided in a clinical setting are an effective modality to treat workers suffering from RC tendinopathy and to promote return-to-work. Further high quality studies comparing different rehabilitation programs including exercises in different settings with defined workers populations are needed to draw firm conclusions on the optimal program to treat workers. PMID:27488037

Efficacy of exercise therapy in workers with rotator cuff tendinopathy: a systematic review.

PubMed

Desmeules, François; Boudreault, Jennifer; Dionne, Clermont E; Frémont, Pierre; Lowry, Véronique; MacDermid, Joy C; Roy, Jean-Sébastien

2016-09-30

To perform a systematic review of randomized controlled trials (RCTs) on the efficacy of therapeutic exercises for workers suffering from rotator cuff (RC) tendinopathy. A literature search in four bibliographical databases (Pubmed, CINAHL, EMBASE, and PEDro) was conducted from inception up to February 2015. RCTs were included if participants were workers suffering from RC tendinopathy, the outcome measures included work-related outcomes, and at least one of the interventions under study included exercises. The methodological quality of the studies was evaluated with the Cochrane Risk of Bias Assessment tool. The mean methodological score of the ten included studies was 54.4%±17.2%. Types of workers included were often not defined, and work-related outcome measures were heterogeneous and often not validated. Three RCTs of moderate methodological quality concluded that exercises were superior to a placebo or no intervention in terms of function and return-to-work outcomes. No significant difference was found between surgery and exercises based on the results of two studies of low to moderate methodological quality. One study of low methodological quality, comparing a workplace-based exercise program focusing on the participants' work demands to an exercise program delivered in a clinical setting, concluded that the work-based intervention was superior in terms of function and return-to-work outcomes. There is low to moderate-grade evidence that therapeutic exercises provided in a clinical setting are an effective modality to treat workers suffering from RC tendinopathy and to promote return-to-work. Further high quality studies comparing different rehabilitation programs including exercises in different settings with defined workers populations are needed to draw firm conclusions on the optimal program to treat workers.

Appraising the methodological quality of the clinical practice guideline for diabetes mellitus using the AGREE II instrument: a methodological evaluation.

PubMed

Radwan, Mahmoud; Akbari Sari, Ali; Rashidian, Arash; Takian, Amirhossein; Abou-Dagga, Sanaa; Elsous, Aymen

2017-02-01

To evaluate the methodological quality of the Palestinian Clinical Practice Guideline for Diabetes Mellitus using the Translated Arabic Version of the AGREE II. Methodological evaluation. A cross-cultural adaptation framework was followed to translate and develop a standardised Translated Arabic Version of the AGREE II. Palestinian Primary Healthcare Centres. Sixteen appraisers independently evaluated the Clinical Practice Guideline for Diabetes Mellitus using the Translated Arabic Version of the AGREE II. Methodological quality of diabetic guideline. The Translated Arabic Version of the AGREE II showed an acceptable reliability and validity. Internal consistency ranged between 0.67 and 0.88 (Cronbach's α). Intra-class coefficient among appraisers ranged between 0.56 and 0.88. The quality of this guideline is low. Both domains 'Scope and Purpose' and 'Clarity of Presentation' had the highest quality scores (66.7% and 61.5%, respectively), whereas the scores for 'Applicability', 'Stakeholder Involvement', 'Rigour of Development' and 'Editorial Independence' were the lowest (27%, 35%, 36.5%, and 40%, respectively). The findings suggest that the quality of this Clinical Practice Guideline is disappointingly low. To improve the quality of current and future guidelines, the AGREE II instrument is extremely recommended to be incorporated as a gold standard for developing, evaluating or updating the Palestinian Clinical Practice Guidelines. Future guidelines can be improved by setting specific strategies to overcome implementation barriers with respect to economic considerations, engaging of all relevant end-users and patients, ensuring a rigorous methodology for searching, selecting and synthesising the evidences and recommendations, and addressing potential conflict of interests within the development group.

The trials methodological research agenda: results from a priority setting exercise.

PubMed

Tudur Smith, Catrin; Hickey, Helen; Clarke, Mike; Blazeby, Jane; Williamson, Paula

2014-01-23

Research into the methods used in the design, conduct, analysis, and reporting of clinical trials is essential to ensure that effective methods are available and that clinical decisions made using results from trials are based on the best available evidence, which is reliable and robust. An on-line Delphi survey of 48 UK Clinical Research Collaboration registered Clinical Trials Units (CTUs) was undertaken. During round one, CTU Directors were asked to identify important topics that require methodological research. During round two, their opinion about the level of importance of each topic was recorded, and during round three, they were asked to review the group's average opinion and revise their previous opinion if appropriate. Direct reminders were sent to maximise the number of responses at each round. Results are summarised using descriptive methods. Forty one (85%) CTU Directors responded to at least one round of the Delphi process: 25 (52%) responded in round one, 32 (67%) responded in round two, 24 (50%) responded in round three. There were only 12 (25%) who responded to all three rounds and 18 (38%) who responded to both rounds two and three. Consensus was achieved amongst CTU Directors that the top three priorities for trials methodological research were 'Research into methods to boost recruitment in trials' (considered the highest priority), 'Methods to minimise attrition' and 'Choosing appropriate outcomes to measure'. Fifty other topics were included in the list of priorities and consensus was reached that two topics, 'Radiotherapy study designs' and 'Low carbon trials', were not priorities. This priority setting exercise has identified the research topics felt to be most important to the key stakeholder group of Directors of UKCRC registered CTUs. The use of robust methodology to identify these priorities will help ensure that this work informs the trials methodological research agenda, with a focus on topics that will have most impact and relevance.

The trials methodological research agenda: results from a priority setting exercise

PubMed Central

2014-01-01

Background Research into the methods used in the design, conduct, analysis, and reporting of clinical trials is essential to ensure that effective methods are available and that clinical decisions made using results from trials are based on the best available evidence, which is reliable and robust. Methods An on-line Delphi survey of 48 UK Clinical Research Collaboration registered Clinical Trials Units (CTUs) was undertaken. During round one, CTU Directors were asked to identify important topics that require methodological research. During round two, their opinion about the level of importance of each topic was recorded, and during round three, they were asked to review the group’s average opinion and revise their previous opinion if appropriate. Direct reminders were sent to maximise the number of responses at each round. Results are summarised using descriptive methods. Results Forty one (85%) CTU Directors responded to at least one round of the Delphi process: 25 (52%) responded in round one, 32 (67%) responded in round two, 24 (50%) responded in round three. There were only 12 (25%) who responded to all three rounds and 18 (38%) who responded to both rounds two and three. Consensus was achieved amongst CTU Directors that the top three priorities for trials methodological research were ‘Research into methods to boost recruitment in trials’ (considered the highest priority), ‘Methods to minimise attrition’ and ‘Choosing appropriate outcomes to measure’. Fifty other topics were included in the list of priorities and consensus was reached that two topics, ‘Radiotherapy study designs’ and ‘Low carbon trials’, were not priorities. Conclusions This priority setting exercise has identified the research topics felt to be most important to the key stakeholder group of Directors of UKCRC registered CTUs. The use of robust methodology to identify these priorities will help ensure that this work informs the trials methodological research agenda, with a focus on topics that will have most impact and relevance. PMID:24456928

Case Study: Applying OpenEHR Archetypes to a Clinical Data Repository in a Chinese Hospital.

PubMed

Min, Lingtong; Wang, Li; Lu, Xudong; Duan, Huilong

2015-01-01

openEHR is a flexible and scalable modeling methodology for clinical information and has been widely adopted in Europe and Australia. Due to the reasons of differences in clinical process and management, there are few research projects involving openEHR in China. To investigate the feasibility of openEHR methodology for clinical information modelling in China, this paper carries out a case study to apply openEHR archetypes to Clinical Data Repository (CDR) in a Chinese hospital. The results show that a set of 26 archetypes are found to cover all the concepts used in the CDR. Of all these, 9 (34.6%) are reused without change, 10 are modified and/or extended, and 7 are newly defined. The reasons for modification, extension and newly definition have been discussed, including granularity of archetype, metadata-level versus data-level modelling, and the representation of relationships between archetypes.

Recent Advances in Resting-State Electroencephalography Biomarkers for Autism Spectrum Disorder-A Review of Methodological and Clinical Challenges.

PubMed

Heunis, Tosca-Marie; Aldrich, Chris; de Vries, Petrus J

2016-08-01

Electroencephalography (EEG) has been used for almost a century to identify seizure-related disorders in humans, typically through expert interpretation of multichannel recordings. Attempts have been made to quantify EEG through frequency analyses and graphic representations. These "traditional" quantitative EEG analysis methods were limited in their ability to analyze complex and multivariate data and have not been generally accepted in clinical settings. There has been growing interest in identification of novel EEG biomarkers to detect early risk of autism spectrum disorder, to identify clinically meaningful subgroups, and to monitor targeted intervention strategies. Most studies to date have, however, used quantitative EEG approaches, and little is known about the emerging multivariate analytical methods or the robustness of candidate biomarkers in the context of the variability of autism spectrum disorder. Here, we present a targeted review of methodological and clinical challenges in the search for novel resting-state EEG biomarkers for autism spectrum disorder. Three primary novel methodologies are discussed: (1) modified multiscale entropy, (2) coherence analysis, and (3) recurrence quantification analysis. Results suggest that these methods may be able to classify resting-state EEG as "autism spectrum disorder" or "typically developing", but many signal processing questions remain unanswered. We suggest that the move to novel EEG analysis methods is akin to the progress in neuroimaging from visual inspection, through region-of-interest analysis, to whole-brain computational analysis. Novel resting-state EEG biomarkers will have to evaluate a range of potential demographic, clinical, and technical confounders including age, gender, intellectual ability, comorbidity, and medication, before these approaches can be translated into the clinical setting. Copyright © 2016 Elsevier Inc. All rights reserved.

Nutrition screening and assessment of anthropometry and bioelectrical impedance in the frail elderly: a clinical appraisal of methodology in a clinical setting.

PubMed

Davidson, Jeanette; Getz, Majorie

2004-01-01

Nutrition screening is recommended to identify those at risk for malnutrition; nutrition assessment by anthropometry and impedance is widely used to indicate nutritional status but may be problematical in the frail elderly in nursing homes. Acceptability, availability, suitability and appropriate reference data influence clinical application of these measurements. In our study, nutrition screening and assessment methodology were evaluated in 46 nursing home residents, mean age 86.3 +/- 6.6 years, mean weight 66.1 +/- 12.9 kg, mean height 163.1 +/- 9.6 cm, and mean BMI 24.9 +/- 4.6 kg/m2. Significant correlations (P < 0.05) were found in all measures of body weight, BMI, body fatness and leanness. Interpretation of data by five different reference standards and cutoff points revealed wide variation in identification of malnutrition by anthropometry. Appropriate reference data for body lean and fatness are not yet available. Thus, population-specific methodology and reference standards are of crucial importance.

Quantification of Hand Motor Symptoms in Parkinson's Disease: A Proof-of-Principle Study Using Inertial and Force Sensors.

PubMed

van den Noort, Josien C; Verhagen, Rens; van Dijk, Kees J; Veltink, Peter H; Vos, Michelle C P M; de Bie, Rob M A; Bour, Lo J; Heida, Ciska T

2017-10-01

This proof-of-principle study describes the methodology and explores and demonstrates the applicability of a system, existing of miniature inertial sensors on the hand and a separate force sensor, to objectively quantify hand motor symptoms in patients with Parkinson's disease (PD) in a clinical setting (off- and on-medication condition). Four PD patients were measured in off- and on- dopaminergic medication condition. Finger tapping, rapid hand opening/closing, hand pro/supination, tremor during rest, mental task and kinetic task, and wrist rigidity movements were measured with the system (called the PowerGlove). To demonstrate applicability, various outcome parameters of measured hand motor symptoms of the patients in off- vs. on-medication condition are presented. The methodology described and results presented show applicability of the PowerGlove in a clinical research setting, to objectively quantify hand bradykinesia, tremor and rigidity in PD patients, using a single system. The PowerGlove measured a difference in off- vs. on-medication condition in all tasks in the presented patients with most of its outcome parameters. Further study into the validity and reliability of the outcome parameters is required in a larger cohort of patients, to arrive at an optimal set of parameters that can assist in clinical evaluation and decision-making.

Application of systematic review methodology to the field of nutrition

USDA-ARS?s Scientific Manuscript database

Systematic reviews represent a rigorous and transparent approach of synthesizing scientific evidence that minimizes bias. They evolved within the medical community to support development of clinical and public health practice guidelines, set research agendas and formulate scientific consensus state...

Effectiveness of implementation strategies for clinical guidelines to community pharmacy: a systematic review.

PubMed

Watkins, Kim; Wood, Helen; Schneider, Carl R; Clifford, Rhonda

2015-10-29

The clinical role of community pharmacists is expanding, as is the use of clinical guidelines in this setting. However, it is unclear which strategies are successful in implementing clinical guidelines and what outcomes can be achieved. The aim of this systematic review is to synthesise the literature on the implementation of clinical guidelines to community pharmacy. The objectives are to describe the implementation strategies used, describe the resulting outcomes and to assess the effectiveness of the strategies. A systematic search was performed in six electronic databases (Medline, EMBASE, CINAHL, Web of Science, Informit, Cochrane Library) for relevant articles. Studies were included if they reported on clinical guidelines implementation strategies in the community pharmacy setting. Two researchers completed the full-search strategy, data abstraction and quality assessments, independently. A third researcher acted as a moderator. Quality assessments were completed with three validated tools. A narrative synthesis was performed to analyse results. A total of 1937 articles were retrieved and the titles and abstracts were screened. Full-text screening was completed for 36 articles resulting in 19 articles (reporting on 22 studies) included for review. Implementation strategies were categorised according to a modified version of the EPOC taxonomy. Educational interventions were the most commonly utilised strategy (n = 20), and computerised decision support systems demonstrated the greatest effect (n = 4). Most studies were multifaceted and used more than one implementation strategy (n = 18). Overall outcomes were moderately positive (n = 17) but focused on process (n = 22) rather than patient (n = 3) or economic outcomes (n = 3). Most studies (n = 20) were rated as being of low methodological quality and having low or very low quality of evidence for outcomes. Studies in this review did not generally have a well thought-out rationale for the choice of implementation strategy. Most utilised educational strategies, but the greatest effect on outcomes was demonstrated using computerised clinical decision support systems. Poor methodology, in the majority of the research, provided insufficient evidence to be conclusive about the best implementation strategies or the benefit of clinical guidelines in this setting. However, the generally positive outcomes across studies and strategies indicate that implementing clinical guidelines to community pharmacy might be beneficial. Improved methodological rigour in future research is required to strengthen the evidence for this hypothesis. PROSPERO 2012: CRD42012003019 .

The quality of care in occupational therapy: an assessment of selected Michigan hospitals.

PubMed

Kirchman, M M

1979-07-01

In this study, a methodology was developed and tested for assessing the quality of care in occupational therapy between educational and noneducational clinical settings, as measured by process and outcome. An instrument was constructed for an external audit of the hospital record. Standards drafted by the investigator were established as normative by a panel of experts for use in judging the programs. Hospital records of 84 patients with residual hemiparesis or hemiplegia in three noneducational settings and of 100 patients with similar diagnoses in two educational clinical settings from selected Michigan facilities were chosen by proportionate stratified random sampling. The process study showed that occupational therapy was of significantly higher quality in the educational settings. The outcome study did not show significant differences between types of settings. Implications for education and practice are discussed.

Human-based approaches to pharmacology and cardiology: an interdisciplinary and intersectorial workshop.

PubMed

Rodriguez, Blanca; Carusi, Annamaria; Abi-Gerges, Najah; Ariga, Rina; Britton, Oliver; Bub, Gil; Bueno-Orovio, Alfonso; Burton, Rebecca A B; Carapella, Valentina; Cardone-Noott, Louie; Daniels, Matthew J; Davies, Mark R; Dutta, Sara; Ghetti, Andre; Grau, Vicente; Harmer, Stephen; Kopljar, Ivan; Lambiase, Pier; Lu, Hua Rong; Lyon, Aurore; Minchole, Ana; Muszkiewicz, Anna; Oster, Julien; Paci, Michelangelo; Passini, Elisa; Severi, Stefano; Taggart, Peter; Tinker, Andy; Valentin, Jean-Pierre; Varro, Andras; Wallman, Mikael; Zhou, Xin

2016-09-01

Both biomedical research and clinical practice rely on complex datasets for the physiological and genetic characterization of human hearts in health and disease. Given the complexity and variety of approaches and recordings, there is now growing recognition of the need to embed computational methods in cardiovascular medicine and science for analysis, integration and prediction. This paper describes a Workshop on Computational Cardiovascular Science that created an international, interdisciplinary and inter-sectorial forum to define the next steps for a human-based approach to disease supported by computational methodologies. The main ideas highlighted were (i) a shift towards human-based methodologies, spurred by advances in new in silico, in vivo, in vitro, and ex vivo techniques and the increasing acknowledgement of the limitations of animal models. (ii) Computational approaches complement, expand, bridge, and integrate in vitro, in vivo, and ex vivo experimental and clinical data and methods, and as such they are an integral part of human-based methodologies in pharmacology and medicine. (iii) The effective implementation of multi- and interdisciplinary approaches, teams, and training combining and integrating computational methods with experimental and clinical approaches across academia, industry, and healthcare settings is a priority. (iv) The human-based cross-disciplinary approach requires experts in specific methodologies and domains, who also have the capacity to communicate and collaborate across disciplines and cross-sector environments. (v) This new translational domain for human-based cardiology and pharmacology requires new partnerships supported financially and institutionally across sectors. Institutional, organizational, and social barriers must be identified, understood and overcome in each specific setting. © The Author 2015. Published by Oxford University Press on behalf of the European Society of Cardiology.

Clinical Physiologic Research Instrumentation: An Approach Using Modular Elements and Distributed Processing

PubMed Central

Hagen, R. W.; Ambos, H. D.; Browder, M. W.; Roloff, W. R.; Thomas, L. J.

1979-01-01

The Clinical Physiologic Research System (CPRS) developed from our experience in applying computers to medical instrumentation problems. This experience revealed a set of applications with a commonality in data acquisition, analysis, input/output, and control needs that could be met by a portable system. The CPRS demonstrates a practical methodology for integrating commercial instruments with distributed modular elements of local design in order to make facile responses to changing instrumentation needs in clinical environments. ImagesFigure 3

Systematic review of the evidence related to mandated nurse staffing ratios in acute hospitals.

PubMed

Olley, Richard; Edwards, Ian; Avery, Mark; Cooper, Helen

2018-04-17

Objective The purpose of this systematic review was to evaluate and summarise available research on nurse staffing methods and relate these to outcomes under three overarching themes of: (1) management of clinical risk, quality and safety; (2) development of a new or innovative staffing methodology; and (3) equity of nursing workload. Methods The PRISMA method was used. Relevant articles were located by searching via the Griffith University Library electronic catalogue, including articles on PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL) and Medline. Only English language publications published between 1 January 2010 and 30 April 2016 focusing on methodologies in acute hospital in-patient units were included in the present review. Results Two of the four staffing methods were found to have evidenced-based articles from empirical studies within the parameters set for inclusion. Of the four staffing methodologies searched, supply and demand returned 10 studies and staffing ratios returned 11. Conclusions There is a need to develop an evidence-based nurse-sensitive outcomes measure upon which staffing for safety, quality and workplace equity, as well as an instrument that reliability and validly projects nurse staffing requirements in a variety of clinical settings. Nurse-sensitive indicators reflect elements of patient care that are directly affected by nursing practice In addition, these measures must take into account patient satisfaction, workload and staffing, clinical risks and other measures of the quality and safety of care and nurses' work satisfaction. i. What is known about the topic? Nurse staffing is a controversial topic that has significant patient safety, quality of care, human resources and financial implications. In acute care services, nursing accounts for approximately 70% of salaries and wages paid by health services budgets, and evidence as to the efficacy and effectiveness of any staffing methodology is required because it has workforce and industrial relations implications. Although there is significant literature available on the topic, there is a paucity of empirical evidence supporting claims of increased patient safety in the acute hospital setting, but some evidence exists relating to equity of workload for nurses. What does this paper add? This paper provides a contemporary qualitative analysis of empirical evidence using PRISMA methodology to conduct a systematic review of the available literature. It demonstrates a significant research gap to support claims of increased patient safety in the acute hospital setting. The paper calls for greatly improved datasets upon which research can be undertaken to determine any associations between mandated patient to nurse ratios and other staffing methodologies and patient safety and quality of care. What are the implications for practitioners? There is insufficient contemporary research to support staffing methodologies for appropriate staffing, balanced workloads and quality, safe care. Such research would include the establishment of nurse-sensitive patient outcomes measures, and more robust datasets are needed for empirical analysis to produce such evidence.

Building the foundation to generate a fundamental care standardised data set.

PubMed

Jeffs, Lianne; Muntlin Athlin, Asa; Needleman, Jack; Jackson, Debra; Kitson, Alison

2018-06-01

This paper provides an overview of the current state of performance measurement, key trends and a methodological approach to leverage in efforts to generate a standardised data set for fundamental care. Considerable transformation is occurring in health care globally with organisations focusing on achieving the quadruple aim of improving the experience of care, the health of populations, and the experience of providing care while reducing per capita costs of health care. In response, healthcare organisations are employing performance measurement and quality improvement methods to achieve the quadruple aim. Despite the plethora of measures available to health managers, there is no standardised data set and virtually no indicators reflecting how patients actually experience the delivery of fundamental care, such as nutrition, hydration, mobility, respect, education and psychosocial support. Given the linkages of fundamental care to safety and quality metrics, efforts to build the evidence base and knowledge that captures the impact of enacting fundamental care across the healthcare continuum and lifespan should include generating a routinely collected data set of relevant measures. This paper provides an overview of the current state of performance measurement, key trends and a methodological approach to leverage in efforts to generate a standardised data set for fundamental care. Standardised data sets enable comparability of data across clinical populations, healthcare sectors, geographic locations and time and provide data about care to support clinical, administrative and health policy decision-making. © 2018 John Wiley & Sons Ltd.

A taxonomy of multinational ethical and methodological standards for clinical trials of therapeutic interventions

PubMed Central

Ashton, Carol M; Wray, Nelda P; Jarman, Anna F; Kolman, Jacob M; Wenner, Danielle M; Brody, Baruch A

2013-01-01

Background If trials of therapeutic interventions are to serve society’s interests, they must be of high methodological quality and must satisfy moral commitments to human subjects. The authors set out to develop a clinical-trials compendium in which standards for the ethical treatment of human subjects are integrated with standards for research methods. Methods The authors rank-ordered the world’s nations and chose the 31 with >700 active trials as of 24 July 2008. Governmental and other authoritative entities of the 31 countries were searched, and 1004 English-language documents containing ethical and/or methodological standards for clinical trials were identified. The authors extracted standards from 144 of those: 50 designated as ‘core’, 39 addressing trials of invasive procedures and a 5% sample (N=55) of the remainder. As the integrating framework for the standards we developed a coherent taxonomy encompassing all elements of a trial’s stages. Findings Review of the 144 documents yielded nearly 15 000 discrete standards. After duplicates were removed, 5903 substantive standards remained, distributed in the taxonomy as follows: initiation, 1401 standards, 8 divisions; design, 1869 standards, 16 divisions; conduct, 1473 standards, 8 divisions; analysing and reporting results, 997 standards, four divisions; and post-trial standards, 168 standards, 5 divisions. Conclusions The overwhelming number of source documents and standards uncovered in this study was not anticipated beforehand and confirms the extraordinary complexity of the clinical trials enterprise. This taxonomy of multinational ethical and methodological standards may help trialists and overseers improve the quality of clinical trials, particularly given the globalisation of clinical research. PMID:21429960

A taxonomy of multinational ethical and methodological standards for clinical trials of therapeutic interventions.

PubMed

Ashton, Carol M; Wray, Nelda P; Jarman, Anna F; Kolman, Jacob M; Wenner, Danielle M; Brody, Baruch A

2011-06-01

If trials of therapeutic interventions are to serve society's interests, they must be of high methodological quality and must satisfy moral commitments to human subjects. The authors set out to develop a clinical-trials compendium in which standards for the ethical treatment of human subjects are integrated with standards for research methods. The authors rank-ordered the world's nations and chose the 31 with >700 active trials as of 24 July 2008. Governmental and other authoritative entities of the 31 countries were searched, and 1004 English-language documents containing ethical and/or methodological standards for clinical trials were identified. The authors extracted standards from 144 of those: 50 designated as 'core', 39 addressing trials of invasive procedures and a 5% sample (N=55) of the remainder. As the integrating framework for the standards we developed a coherent taxonomy encompassing all elements of a trial's stages. Review of the 144 documents yielded nearly 15 000 discrete standards. After duplicates were removed, 5903 substantive standards remained, distributed in the taxonomy as follows: initiation, 1401 standards, 8 divisions; design, 1869 standards, 16 divisions; conduct, 1473 standards, 8 divisions; analysing and reporting results, 997 standards, four divisions; and post-trial standards, 168 standards, 5 divisions. The overwhelming number of source documents and standards uncovered in this study was not anticipated beforehand and confirms the extraordinary complexity of the clinical trials enterprise. This taxonomy of multinational ethical and methodological standards may help trialists and overseers improve the quality of clinical trials, particularly given the globalisation of clinical research.

Instruments evaluating the quality of the clinical learning environment in nursing education: A systematic review of psychometric properties.

PubMed

Mansutti, Irene; Saiani, Luisa; Grassetti, Luca; Palese, Alvisa

2017-03-01

The clinical learning environment is fundamental to nursing education paths, capable of affecting learning processes and outcomes. Several instruments have been developed in nursing education, aimed at evaluating the quality of the clinical learning environments; however, no systematic review of the psychometric properties and methodological quality of these studies has been performed to date. The aims of the study were: 1) to identify validated instruments evaluating the clinical learning environments in nursing education; 2) to evaluate critically the methodological quality of the psychometric property estimation used; and 3) to compare psychometric properties across the instruments available. A systematic review of the literature (using the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines) and an evaluation of the methodological quality of psychometric properties (using the COnsensus-based Standards for the selection of health Measurement INstruments guidelines). The Medline and CINAHL databases were searched. Eligible studies were those that satisfied the following criteria: a) validation studies of instruments evaluating the quality of clinical learning environments; b) in nursing education; c) published in English or Italian; d) before April 2016. The included studies were evaluated for the methodological quality of the psychometric properties measured and then compared in terms of both the psychometric properties and the methodological quality of the processes used. The search strategy yielded a total of 26 studies and eight clinical learning environment evaluation instruments. A variety of psychometric properties have been estimated for each instrument, with differing qualities in the methodology used. Concept and construct validity were poorly assessed in terms of their significance and rarely judged by the target population (nursing students). Some properties were rarely considered (e.g., reliability, measurement error, criterion validity), whereas others were frequently estimated, but using different coefficients and statistical analyses (e.g., internal consistency, structural validity), thus rendering comparison across instruments difficult. Moreover, the methodological quality adopted in the property assessments was poor or fair in most studies, compromising the goodness of the psychometric values estimated. Clinical learning placements represent the key strategies in educating the future nursing workforce: instruments evaluating the quality of the settings, as well as their capacity to promote significant learning, are strongly recommended. Studies estimating psychometric properties, using an increased quality of research methodologies are needed in order to support nursing educators in the process of clinical placements accreditation and quality improvement. Copyright © 2017 Elsevier Ltd. All rights reserved.

Design and implementation of a controlled clinical trial to evaluate the effectiveness and efficiency of routine opt-out rapid human immunodeficiency virus screening in the emergency department.

PubMed

Haukoos, Jason S; Hopkins, Emily; Byyny, Richard L; Conroy, Amy A; Silverman, Morgan; Eisert, Sheri; Thrun, Mark; Wilson, Michael; Boyett, Brian; Heffelfinger, James D

2009-08-01

In 2006, the Centers for Disease Control and Prevention (CDC) released revised recommendations for performing human immunodeficiency virus (HIV) testing in health care settings, including implementing routine rapid HIV screening, the use of an integrated opt-out consent, and limited prevention counseling. Emergency departments (EDs) have been a primary focus of these efforts. These revised CDC recommendations were primarily based on feasibility studies and have not been evaluated through the application of rigorous research methods. This article describes the design and implementation of a large prospective controlled clinical trial to evaluate the CDC's recommendations in an ED setting. From April 15, 2007, through April 15, 2009, a prospective quasi-experimental equivalent time-samples clinical trial was performed to compare the clinical effectiveness and efficiency of routine (nontargeted) opt-out rapid HIV screening (intervention) to physician-directed diagnostic rapid HIV testing (control) in a high-volume urban ED. In addition, three nested observational studies were performed to evaluate the cost-effectiveness and patient and staff acceptance of the two rapid HIV testing methods. This article describes the rationale, methodologies, and study design features of this program evaluation clinical trial. It also provides details regarding the integration of the principal clinical trial and its nested observational studies. Such ED-based trials are rare, but serve to provide valid comparisons between testing approaches. Investigators should consider similar methodology when performing future ED-based health services research.

Third year nursing students' viewpoints about circumstances which threaten safety in the clinical setting.

PubMed

Montgomery, Phyllis; Killam, Laura; Mossey, Sharolyn; Heerschap, Corey

2014-02-01

Evidence emphasizes that learners, educators, clinicians, programs, and organizations share the responsibility for establishing and maintaining safety throughout undergraduate nursing education. Increased knowledge about students' perceptions of threats to safety in the clinical setting may guide educators' efforts to promote the development of safe novice practitioners while preserving patient safety. The purpose of this study was to describe third year nursing students' viewpoints of the circumstances which threaten safety in the clinical setting. Using Q methodology, 34 third year Bachelor of Science in Nursing students sorted 43 theoretical statement cards. Each card identified a statement describing a threat to safety in the clinical setting. These statements were generated through a review of nursing literature and consultation with experts in nursing education. Centroid factor analysis and varimax rotation identified viewpoints regarding circumstances that most threaten safety. Three discrete viewpoints and one consensus perspective constituted students' description of threatened safety. The discrete viewpoints were labeled lack of readiness, misdirected practices, and negation of professional boundaries. There was consensus that it is most unsafe in the clinical setting when novices fail to consolidate an integrated cognitive, behavioral, and ethical identity. This unifying perspective was labeled non-integration. Third year nursing students and their educators are encouraged to be mindful of the need to ensure readiness prior to entry into the clinical setting. In the clinical setting, the learning of prepared students must be guided by competent educators. Finally, both students and their educators must respect professional boundaries to promote safety for students and patients. © 2013.

Development of Bioethics and Clinical Ethics in Bulgaria.

PubMed

Aleksandrova-Yankulovska, Silviya S

2017-03-01

Bioethics and clinical ethics emerged from the classical medical ethics in the 1970s of the 20th century. Both fields are new for the Bulgarian academic tradition. The aims of this paper were to demarcate the subject fields of medical ethics, bioethics, and clinical ethics, to present the developments in the field of medical ethics in Bulgaria, to delineate the obstacles to effective ethics education of medical professionals, and to present the results of the application of an adapted bottom-up methodology for clinical ethics consultation in several clinical units in Bulgaria. Extended literature review and application of an adapted METAP methodology for clinical ethics consultation in six clinical units in the Northern Bulgaria between May 2013 and December 2014. Teaching of medical ethics in Bulgaria was introduced in the 1990s and still stands mainly as theoretical expertise without sufficient dilemma training in clinical settings. Earlier studies revealed need of clinical ethics consultation services in our country. METAP methodology was applied in 69 ethics meetings. In 31.9% of them non-medical considerations affected the choice of treatment and 34.8% resulted in reaching consensus between the team and the patient. Participants' opinion about the meetings was highly positive with 87.7% overall satisfaction. Development of bioethics in Bulgaria follows recent worldwide trends. Several ideas could be applied towards increasing the effectiveness of ethics education. Results of the ethics meetings lead to the conclusion that it is a successful and well accepted approach for clinical ethics consultation with a potential for wider introduction in our medical practice.

Identifying treatment effect heterogeneity in clinical trials using subpopulations of events: STEPP.

PubMed

Lazar, Ann A; Bonetti, Marco; Cole, Bernard F; Yip, Wai-Ki; Gelber, Richard D

2016-04-01

Investigators conducting randomized clinical trials often explore treatment effect heterogeneity to assess whether treatment efficacy varies according to patient characteristics. Identifying heterogeneity is central to making informed personalized healthcare decisions. Treatment effect heterogeneity can be investigated using subpopulation treatment effect pattern plot (STEPP), a non-parametric graphical approach that constructs overlapping patient subpopulations with varying values of a characteristic. Procedures for statistical testing using subpopulation treatment effect pattern plot when the endpoint of interest is survival remain an area of active investigation. A STEPP analysis was used to explore patterns of absolute and relative treatment effects for varying levels of a breast cancer biomarker, Ki-67, in the phase III Breast International Group 1-98 randomized clinical trial, comparing letrozole to tamoxifen as adjuvant therapy for postmenopausal women with hormone receptor-positive breast cancer. Absolute treatment effects were measured by differences in 4-year cumulative incidence of breast cancer recurrence, while relative effects were measured by the subdistribution hazard ratio in the presence of competing risks using O-E (observed-minus-expected) methodology, an intuitive non-parametric method. While estimation of hazard ratio values based on O-E methodology has been shown, a similar development for the subdistribution hazard ratio has not. Furthermore, we observed that the subpopulation treatment effect pattern plot analysis may not produce results, even with 100 patients within each subpopulation. After further investigation through simulation studies, we observed inflation of the type I error rate of the traditional test statistic and sometimes singular variance-covariance matrix estimates that may lead to results not being produced. This is due to the lack of sufficient number of events within the subpopulations, which we refer to as instability of the subpopulation treatment effect pattern plot analysis. We introduce methodology designed to improve stability of the subpopulation treatment effect pattern plot analysis and generalize O-E methodology to the competing risks setting. Simulation studies were designed to assess the type I error rate of the tests for a variety of treatment effect measures, including subdistribution hazard ratio based on O-E estimation. This subpopulation treatment effect pattern plot methodology and standard regression modeling were used to evaluate heterogeneity of Ki-67 in the Breast International Group 1-98 randomized clinical trial. We introduce methodology that generalizes O-E methodology to the competing risks setting and that improves stability of the STEPP analysis by pre-specifying the number of events across subpopulations while controlling the type I error rate. The subpopulation treatment effect pattern plot analysis of the Breast International Group 1-98 randomized clinical trial showed that patients with high Ki-67 percentages may benefit most from letrozole, while heterogeneity was not detected using standard regression modeling. The STEPP methodology can be used to study complex patterns of treatment effect heterogeneity, as illustrated in the Breast International Group 1-98 randomized clinical trial. For the subpopulation treatment effect pattern plot analysis, we recommend a minimum of 20 events within each subpopulation. © The Author(s) 2015.

Methodological Quality of Consensus Guidelines in Implant Dentistry.

PubMed

Faggion, Clovis Mariano; Apaza, Karol; Ariza-Fritas, Tania; Málaga, Lilian; Giannakopoulos, Nikolaos Nikitas; Alarcón, Marco Antonio

2017-01-01

Consensus guidelines are useful to improve clinical decision making. Therefore, the methodological evaluation of these guidelines is of paramount importance. Low quality information may guide to inadequate or harmful clinical decisions. To evaluate the methodological quality of consensus guidelines published in implant dentistry using a validated methodological instrument. The six implant dentistry journals with impact factors were scrutinised for consensus guidelines related to implant dentistry. Two assessors independently selected consensus guidelines, and four assessors independently evaluated their methodological quality using the Appraisal of Guidelines for Research & Evaluation (AGREE) II instrument. Disagreements in the selection and evaluation of guidelines were resolved by consensus. First, the consensus guidelines were analysed alone. Then, systematic reviews conducted to support the guidelines were included in the analysis. Non-parametric statistics for dependent variables (Wilcoxon signed rank test) was used to compare both groups. Of 258 initially retrieved articles, 27 consensus guidelines were selected. Median scores in four domains (applicability, rigour of development, stakeholder involvement, and editorial independence), expressed as percentages of maximum possible domain scores, were below 50% (median, 26%, 30.70%, 41.70%, and 41.70%, respectively). The consensus guidelines and consensus guidelines + systematic reviews data sets could be compared for 19 guidelines, and the results showed significant improvements in all domain scores (p < 0.05). Methodological improvement of consensus guidelines published in major implant dentistry journals is needed. The findings of the present study may help researchers to better develop consensus guidelines in implant dentistry, which will improve the quality and trust of information needed to make proper clinical decisions.

Methodological Quality of Consensus Guidelines in Implant Dentistry

PubMed Central

Faggion, Clovis Mariano; Apaza, Karol; Ariza-Fritas, Tania; Málaga, Lilian; Giannakopoulos, Nikolaos Nikitas; Alarcón, Marco Antonio

2017-01-01

Background Consensus guidelines are useful to improve clinical decision making. Therefore, the methodological evaluation of these guidelines is of paramount importance. Low quality information may guide to inadequate or harmful clinical decisions. Objective To evaluate the methodological quality of consensus guidelines published in implant dentistry using a validated methodological instrument. Methods The six implant dentistry journals with impact factors were scrutinised for consensus guidelines related to implant dentistry. Two assessors independently selected consensus guidelines, and four assessors independently evaluated their methodological quality using the Appraisal of Guidelines for Research & Evaluation (AGREE) II instrument. Disagreements in the selection and evaluation of guidelines were resolved by consensus. First, the consensus guidelines were analysed alone. Then, systematic reviews conducted to support the guidelines were included in the analysis. Non-parametric statistics for dependent variables (Wilcoxon signed rank test) was used to compare both groups. Results Of 258 initially retrieved articles, 27 consensus guidelines were selected. Median scores in four domains (applicability, rigour of development, stakeholder involvement, and editorial independence), expressed as percentages of maximum possible domain scores, were below 50% (median, 26%, 30.70%, 41.70%, and 41.70%, respectively). The consensus guidelines and consensus guidelines + systematic reviews data sets could be compared for 19 guidelines, and the results showed significant improvements in all domain scores (p < 0.05). Conclusions Methodological improvement of consensus guidelines published in major implant dentistry journals is needed. The findings of the present study may help researchers to better develop consensus guidelines in implant dentistry, which will improve the quality and trust of information needed to make proper clinical decisions. PMID:28107405

Minimum reporting standards for clinical research on groin pain in athletes

PubMed Central

Delahunt, Eamonn; Thorborg, Kristian; Khan, Karim M; Robinson, Philip; Hölmich, Per; Weir, Adam

2015-01-01

Groin pain in athletes is a priority area for sports physiotherapy and sports medicine research. Heterogeneous studies with low methodological quality dominate research related to groin pain in athletes. Low-quality studies undermine the external validity of research findings and limit the ability to generalise findings to the target patient population. Minimum reporting standards for research on groin pain in athletes are overdue. We propose a set of minimum reporting standards based on best available evidence to be utilised in future research on groin pain in athletes. Minimum reporting standards are provided in relation to: (1) study methodology, (2) study participants and injury history, (3) clinical examination, (4) clinical assessment and (5) radiology. Adherence to these minimum reporting standards will strengthen the quality and transparency of research conducted on groin pain in athletes. This will allow an easier comparison of outcomes across studies in the future. PMID:26031644

Knowledge mining from clinical datasets using rough sets and backpropagation neural network.

PubMed

Nahato, Kindie Biredagn; Harichandran, Khanna Nehemiah; Arputharaj, Kannan

2015-01-01

The availability of clinical datasets and knowledge mining methodologies encourages the researchers to pursue research in extracting knowledge from clinical datasets. Different data mining techniques have been used for mining rules, and mathematical models have been developed to assist the clinician in decision making. The objective of this research is to build a classifier that will predict the presence or absence of a disease by learning from the minimal set of attributes that has been extracted from the clinical dataset. In this work rough set indiscernibility relation method with backpropagation neural network (RS-BPNN) is used. This work has two stages. The first stage is handling of missing values to obtain a smooth data set and selection of appropriate attributes from the clinical dataset by indiscernibility relation method. The second stage is classification using backpropagation neural network on the selected reducts of the dataset. The classifier has been tested with hepatitis, Wisconsin breast cancer, and Statlog heart disease datasets obtained from the University of California at Irvine (UCI) machine learning repository. The accuracy obtained from the proposed method is 97.3%, 98.6%, and 90.4% for hepatitis, breast cancer, and heart disease, respectively. The proposed system provides an effective classification model for clinical datasets.

A Narrative in Search of a Methodology.

PubMed

Treloar, Anna; Stone, Teresa Elizabeth; McMillan, Margaret; Flakus, Kirstin

2015-07-01

Research papers present us with the summaries of scholars' work; what we readers do not see are the struggles behind the decision to choose one methodology over another. A student's mental health portfolio contained a narrative that led to an exploration of the most appropriate methodology for a projected study of clinical anecdotes told by nurses who work in mental health settings to undergraduates and new recruits about mental health nursing. This paper describes the process of struggle, beginning with the student's account, before posing a number of questions needing answers before the choice of the most appropriate methodology. We argue, after discussing the case for the use of literary analysis, discourse analysis, symbolic interactionism, hermeneutics, and narrative research, that case study research is the methodology of choice. Case study is frequently used in educational research and is sufficiently flexible to allow for an exploration of the phenomenon. © 2014 Wiley Periodicals, Inc.

A cross-sectional survey of 5-year-old children with non-syndromic unilateral cleft lip and palate: the Cleft Care UK study. Part 1: background and methodology

PubMed Central

Persson, M; Sandy, J R; Waylen, A; Wills, A K; Al-Ghatam, R; Ireland, A J; Hall, A J; Hollingworth, W; Jones, T; Peters, T J; Preston, R; Sell, D; Smallridge, J; Worthington, H; Ness, A R

2015-01-01

Structured Abstract Objectives We describe the methodology for a major study investigating the impact of reconfigured cleft care in the United Kingdom (UK) 15 years after an initial survey, detailed in the Clinical Standards Advisory Group (CSAG) report in 1998, had informed government recommendations on centralization. Setting and Sample Population This is a UK multicentre cross-sectional study of 5-year-olds born with non-syndromic unilateral cleft lip and palate. Children born between 1 April 2005 and 31 March 2007 were seen in cleft centre audit clinics. Materials and Methods Consent was obtained for the collection of routine clinical measures (speech recordings, hearing, photographs, models, oral health, psychosocial factors) and anthropometric measures (height, weight, head circumference). The methodology for each clinical measure followed those of the earlier survey as closely as possible. Results We identified 359 eligible children and recruited 268 (74.7%) to the study. Eleven separate records for each child were collected at the audit clinics. In total, 2666 (90.4%) were collected from a potential 2948 records. The response rates for the self-reported questionnaires, completed at home, were 52.6% for the Health and Lifestyle Questionnaire and 52.2% for the Satisfaction with Service Questionnaire. Conclusions Response rates and measures were similar to those achieved in the previous survey. There are practical, administrative and methodological challenges in repeating cross-sectional surveys 15 years apart and producing comparable data. PMID:26567851

A grid to facilitate physics staffing justification.

PubMed

Klein, Eric E

2009-12-03

Justification of clinical physics staffing levels is difficult due to the lack of direction as how to equate clinical needs with the staffing levels and competency required. When a physicist negotiates staffing requests to administration, she/he often refers to American College of Radiology staffing level suggestions, and resources such as the Abt studies. This approach is often met with questions as to how to fairly derive the time it takes to perform tasks. The result is often insufficient and/or inexperienced staff handling complex and cumbersome tasks. We undertook development of a staffing justification grid to equate the clinical needs to the quantity and quality of staffing required. The first step is using the Abt study, customized to the clinical setting, to derive time per task multiplied by the anticipated number of such tasks. Inclusion of vacation, meeting, and developmental time may be incorporated along with allocated time for education and administration. This is followed by mapping the tasks to the level of competency/experience needed. For example, in an academic setting the faculty appointment levels correlate with experience. Non-staff personnel, such as IMRT QA technicians or clerical staff, should also be part of the equation. By using the staffing justification grid, we derived strong documentation to justify a substantial budget increase. The grid also proved useful when our clinical demands changed. Justification for physics staffing can be significantly strengthened with a properly developed data-based time and work analysis. A staffing grid is presented, along with a development methodology that facilitated our justification. Though our grid is for a large academic facility, the methodology can be extended to a non-academic setting, and to a smaller scale. This grid method not only equates the clinical needs with the quantity of staffing, but can also help generate the personnel budget, based on the type of staff and personnel required. The grid is easily adaptable when changes to the clinical environment change, such as an increase in IMRT or IGRT applications.

Wearable accelerometry-based technology capable of assessing functional activities in neurological populations in community settings: a systematic review.

PubMed

Steins, Dax; Dawes, Helen; Esser, Patrick; Collett, Johnny

2014-03-13

Integrating rehabilitation services through wearable systems has the potential to accurately assess the type, intensity, duration, and quality of movement necessary for procuring key outcome measures. This review aims to explore wearable accelerometry-based technology (ABT) capable of assessing mobility-related functional activities intended for rehabilitation purposes in community settings for neurological populations. In this review, we focus on the accuracy of ABT-based methods, types of outcome measures, and the implementation of ABT in non-clinical settings for rehabilitation purposes. Cochrane, PubMed, Web of Knowledge, EMBASE, and IEEE Xplore. The search strategy covered three main areas, namely wearable technology, rehabilitation, and setting. Potentially relevant studies were categorized as systems either evaluating methods or outcome parameters. Methodological qualities of studies were assessed by two customized checklists, depending on their categorization and rated independently by three blinded reviewers. Twelve studies involving ABT met the eligibility criteria, of which three studies were identified as having implemented ABT for rehabilitation purposes in non-clinical settings. From the twelve studies, seven studies achieved high methodological quality scores. These studies were not only capable of assessing the type, quantity, and quality measures of functional activities, but could also distinguish healthy from non-healthy subjects and/or address disease severity levels. While many studies support ABT's potential for telerehabilitation, few actually utilized it to assess mobility-related functional activities outside laboratory settings. To generate more appropriate outcome measures, there is a clear need to translate research findings and novel methods into practice.

Wearable accelerometry-based technology capable of assessing functional activities in neurological populations in community settings: a systematic review

PubMed Central

2014-01-01

Background Integrating rehabilitation services through wearable systems has the potential to accurately assess the type, intensity, duration, and quality of movement necessary for procuring key outcome measures. Objectives This review aims to explore wearable accelerometry-based technology (ABT) capable of assessing mobility-related functional activities intended for rehabilitation purposes in community settings for neurological populations. In this review, we focus on the accuracy of ABT-based methods, types of outcome measures, and the implementation of ABT in non-clinical settings for rehabilitation purposes. Data sources Cochrane, PubMed, Web of Knowledge, EMBASE, and IEEE Xplore. The search strategy covered three main areas, namely wearable technology, rehabilitation, and setting. Study selection Potentially relevant studies were categorized as systems either evaluating methods or outcome parameters. Methods Methodological qualities of studies were assessed by two customized checklists, depending on their categorization and rated independently by three blinded reviewers. Results Twelve studies involving ABT met the eligibility criteria, of which three studies were identified as having implemented ABT for rehabilitation purposes in non-clinical settings. From the twelve studies, seven studies achieved high methodological quality scores. These studies were not only capable of assessing the type, quantity, and quality measures of functional activities, but could also distinguish healthy from non-healthy subjects and/or address disease severity levels. Conclusion While many studies support ABT’s potential for telerehabilitation, few actually utilized it to assess mobility-related functional activities outside laboratory settings. To generate more appropriate outcome measures, there is a clear need to translate research findings and novel methods into practice. PMID:24625308

A primer on standards setting as it applies to surgical education and credentialing.

PubMed

Cendan, Juan; Wier, Daryl; Behrns, Kevin

2013-07-01

Surgical technological advances in the past three decades have led to dramatic reductions in the morbidity associated with abdominal procedures and permanently altered the surgical practice landscape. Significant changes continue apace including surgical robotics, natural orifice-based surgery, and single-incision approaches. These disruptive technologies have on occasion been injurious to patients, and high-stakes assessment before adoption of new technologies would be reasonable. We reviewed the drivers for well-established psychometric techniques available for the standards-setting process. We present a series of examples that are relevant in the surgical domain including standards setting for knowledge and skills assessments. Defensible standards for knowledge and procedural skills will likely become part of surgical clinical practice. Understanding the methodology for determining standards should position the surgical community to assist in the process and lead within their clinical settings as standards are considered that may affect patient safety and physician credentialing.

Clinical Applications of a CT Window Blending Algorithm: RADIO (Relative Attenuation-Dependent Image Overlay).

PubMed

Mandell, Jacob C; Khurana, Bharti; Folio, Les R; Hyun, Hyewon; Smith, Stacy E; Dunne, Ruth M; Andriole, Katherine P

2017-06-01

A methodology is described using Adobe Photoshop and Adobe Extendscript to process DICOM images with a Relative Attenuation-Dependent Image Overlay (RADIO) algorithm to visualize the full dynamic range of CT in one view, without requiring a change in window and level settings. The potential clinical uses for such an algorithm are described in a pictorial overview, including applications in emergency radiology, oncologic imaging, and nuclear medicine and molecular imaging.

Harmonized clinical trial methodologies for localized cutaneous leishmaniasis and potential for extensive network with capacities for clinical evaluation

PubMed Central

Grogl, Max; Boni, Marina; Carvalho, Edgar M.; Chebli, Houda; Cisse, Mamoudou; Diro, Ermias; Fernandes Cota, Gláucia; Erber, Astrid C.; Gadisa, Endalamaw; Handjani, Farhad; Khamesipour, Ali; Llanos-Cuentas, Alejandro; López Carvajal, Liliana; Grout, Lise; Lmimouni, Badre Eddine; Mokni, Mourad; Nahzat, Mohammad Sami; Ben Salah, Afif; Ozbel, Yusuf; Pascale, Juan Miguel; Rizzo Molina, Nidia; Rode, Joelle; Romero, Gustavo; Ruiz-Postigo, José Antonio; Gore Saravia, Nancy; Soto, Jaime; Uzun, Soner; Mashayekhi, Vahid; Vélez, Ivan Dario; Vogt, Florian; Zerpa, Olga; Arana, Byron

2018-01-01

Introduction Progress with the treatment of cutaneous leishmaniasis (CL) has been hampered by inconsistent methodologies used to assess treatment effects. A sizable number of trials conducted over the years has generated only weak evidence backing current treatment recommendations, as shown by systematic reviews on old-world and new-world CL (OWCL and NWCL). Materials and methods Using a previously published guidance paper on CL treatment trial methodology as the reference, consensus was sought on key parameters including core eligibility and outcome measures, among OWCL (7 countries, 10 trial sites) and NWCL (7 countries, 11 trial sites) during two separate meetings. Results Findings and level of consensus within and between OWCL and NWCL sites are presented and discussed. In addition, CL trial site characteristics and capacities are summarized. Conclusions The consensus reached allows standardization of future clinical research across OWCL and NWCL sites. We encourage CL researchers to adopt and adapt as required the proposed parameters and outcomes in their future trials and provide feedback on their experience. The expertise afforded between the two sets of clinical sites provides the basis for a powerful consortium with potential for extensive, standardized assessment of interventions for CL and faster approval of candidate treatments. PMID:29329311

Methodological Issues in Alcohol Screening and Brief Intervention Research

ERIC Educational Resources Information Center

Kypri, Kypros

2007-01-01

The research literature on screening and brief intervention (SBI) for unhealthy alcohol use is large and diverse. More than 50 clinical trials and 9 systematic reviews have been published on SBI in a range of healthcare settings, and via a variety of delivery approaches, in general practice, hospital wards, emergency departments, addiction…

Overdiagnosis across medical disciplines: a scoping review

PubMed Central

de Groot, Joris A H; Reitsma, Johannes B; Moons, Karel G M; Hooft, Lotty; Naaktgeboren, Christiana A

2017-01-01

Objective To provide insight into how and in what clinical fields overdiagnosis is studied and give directions for further applied and methodological research. Design Scoping review. Data sources Medline up to August 2017. Study selection All English studies on humans, in which overdiagnosis was discussed as a dominant theme. Data extraction Studies were assessed on clinical field, study aim (ie, methodological or non-methodological), article type (eg, primary study, review), the type and role of diagnostic test(s) studied and the context in which these studies discussed overdiagnosis. Results From 4896 studies, 1851 were included for analysis. Half of all studies on overdiagnosis were performed in the field of oncology (50%). Other prevalent clinical fields included mental disorders, infectious diseases and cardiovascular diseases accounting for 9%, 8% and 6% of studies, respectively. Overdiagnosis was addressed from a methodological perspective in 20% of studies. Primary studies were the most common article type (58%). The type of diagnostic tests most commonly studied were imaging tests (32%), although these were predominantly seen in oncology and cardiovascular disease (84%). Diagnostic tests were studied in a screening setting in 43% of all studies, but as high as 75% of all oncological studies. The context in which studies addressed overdiagnosis related most frequently to its estimation, accounting for 53%. Methodology on overdiagnosis estimation and definition provided a source for extensive discussion. Other contexts of discussion included definition of disease, overdiagnosis communication, trends in increasing disease prevalence, drivers and consequences of overdiagnosis, incidental findings and genomics. Conclusions Overdiagnosis is discussed across virtually all clinical fields and in different contexts. The variability in characteristics between studies and lack of consensus on overdiagnosis definition indicate the need for a uniform typology to improve coherence and comparability of studies on overdiagnosis. PMID:29284720

Language matters: towards an understanding of silence and humour in medical education.

PubMed

Lingard, Lorelei

2013-01-01

This paper considers the state of the science regarding language matters in medical education, with particular attention to two informal language practices: silence and humour. Silence and humour pervade clinical training settings, although we rarely attend explicitly to them. This paper considers the treatment of these topics in our field to date and introduces a selection of the scholarship on silence and humour from other fields, including philosophy, sociology, anthropology, linguistics and rhetoric. Particular attention is paid to distilling the theoretical and methodological possibilities for an elaborated research agenda around silence and humour in medical education. These two language practices assume a variety of forms and serve a range of social functions. Episodes of silence and humour are intimately tied to their relational and institutional contexts. Power often figures centrally, although not predictably. A rich theoretical and methodological basis exists on which to elaborate a research agenda around silence and humour in medical education. Such research promises to reveal more fully the contributions of silence and humour to socialisation in clinical training settings. © Blackwell Publishing Ltd 2013.

Clinical Proton MR Spectroscopy in Central Nervous System Disorders

PubMed Central

Alger, Jeffry R.; Barker, Peter B.; Bartha, Robert; Bizzi, Alberto; Boesch, Chris; Bolan, Patrick J.; Brindle, Kevin M.; Cudalbu, Cristina; Dinçer, Alp; Dydak, Ulrike; Emir, Uzay E.; Frahm, Jens; González, Ramón Gilberto; Gruber, Stephan; Gruetter, Rolf; Gupta, Rakesh K.; Heerschap, Arend; Henning, Anke; Hetherington, Hoby P.; Howe, Franklyn A.; Hüppi, Petra S.; Hurd, Ralph E.; Kantarci, Kejal; Klomp, Dennis W. J.; Kreis, Roland; Kruiskamp, Marijn J.; Leach, Martin O.; Lin, Alexander P.; Luijten, Peter R.; Marjańska, Małgorzata; Maudsley, Andrew A.; Meyerhoff, Dieter J.; Mountford, Carolyn E.; Nelson, Sarah J.; Pamir, M. Necmettin; Pan, Jullie W.; Peet, Andrew C.; Poptani, Harish; Posse, Stefan; Pouwels, Petra J. W.; Ratai, Eva-Maria; Ross, Brian D.; Scheenen, Tom W. J.; Schuster, Christian; Smith, Ian C. P.; Soher, Brian J.; Tkáč, Ivan; Vigneron, Daniel B.; Kauppinen, Risto A.

2014-01-01

A large body of published work shows that proton (hydrogen 1 [1H]) magnetic resonance (MR) spectroscopy has evolved from a research tool into a clinical neuroimaging modality. Herein, the authors present a summary of brain disorders in which MR spectroscopy has an impact on patient management, together with a critical consideration of common data acquisition and processing procedures. The article documents the impact of 1H MR spectroscopy in the clinical evaluation of disorders of the central nervous system. The clinical usefulness of 1H MR spectroscopy has been established for brain neoplasms, neonatal and pediatric disorders (hypoxia-ischemia, inherited metabolic diseases, and traumatic brain injury), demyelinating disorders, and infectious brain lesions. The growing list of disorders for which 1H MR spectroscopy may contribute to patient management extends to neurodegenerative diseases, epilepsy, and stroke. To facilitate expanded clinical acceptance and standardization of MR spectroscopy methodology, guidelines are provided for data acquisition and analysis, quality assessment, and interpretation. Finally, the authors offer recommendations to expedite the use of robust MR spectroscopy methodology in the clinical setting, including incorporation of technical advances on clinical units. © RSNA, 2014 Online supplemental material is available for this article. PMID:24568703

Reuse of clinical data.

PubMed

Safran, C

2014-08-15

To provide an overview of the benefits of clinical data collected as a by-product of the care process, the potential problems with large aggregations of these data, the policy frameworks that have been formulated, and the major challenges in the coming years. This report summarizes some of the major observations from AMIA and IMIA conferences held on this admittedly broad topic from 2006 through 2013. This report also includes many unsupported opinions of the author. The benefits of aggregating larger and larger sets of routinely collected clinical data are well documented and of great societal benefit. These large data sets will probably never answer all possible clinical questions for methodological reasons. Non-traditional sources of health data that are patient-sources will pose new data science challenges. If we ever hope to have tools that can rapidly provide evidence for daily practice of medicine we need a science of health data perhaps modeled after the science of astronomy.

Clinical and Public Health Considerations in Urine Drug Testing to Identify and Treat Substance Use.

PubMed

Barthwell, Andrea G

2016-05-11

To expand appropriate use of substance use testing, practitioners must increase their knowledge of the appropriate methodology, scope, and frequency. Yet, there is a current lack of accepted guidelines on clinical testing to identify and treat substance use. This article (1) conveys the importance of substance use testing as a clinical and public health response to trends of prescription drug abuse and increased access to medical and commercialized marijuana; (2) summarizes central features of the rapidly evolving science and the practice of patient-centered substance use testing in a clinical setting; and (3) provides recommendations that balance costs and benefits and serve as a starting point for appropriate testing to prevent, identify, and treat substance use disorders. The author conducted a search of peer-reviewed and government-supported articles and books in electronic databases and used her own knowledge and clinical experience. The author makes recommendations for determining the methodology, scope, and frequency of testing in each stage of care based on clinical considerations and methodological factors. Conclusion/Importance: Integrating sensible substance use testing broadly into clinical health care to identify substance use, diagnose substance use disorders, and guide patients into treatment can improve health outcomes and reduce the costs of substance use and addiction. No single testing regimen is suitable for all clinical scenarios; rather, a multitude of options, as discussed herein, can be adapted to meet a patient's unique needs. Ultimately, the practitioner must combine patient-specific information with knowledge of test technologies, capabilities, limitations, and costs.

Development of Clinical Trial Assessments for the Study of Interstitial Lung Disease in Patients who have Connective Tissue Diseases-Methodological Considerations.

PubMed

Huscher, Dörte; Saketkoo, Lesley Ann; Pittrow, David; Khanna, Dinesh

2010-05-01

This review article discusses the proposed methodology that will be utilized to develop core set items for connective tissue disease-associated interstitial lung disease (CTD-ILD). CTD-ILD remain an important enigma in clinical medicine. No consensus exists on measurement of disease activity or what constitutes a significant response to therapeutic interventions. Lack of appropriate measures inhibit effective drug development and hamper regulatory evaluation of candidate therapies.An interdisciplinary and international Steering Committee (SC) will oversee the execution of a 3-tier Delphi exercise involving experts in CTD and ILD. In parallel to the Delphi, qualitative information will be gathered from patients with ILD using focus groups. These data will subsequently be used to construct surveys to collect quantitative response from patients with ILD. The final Delphi and Patient Perspective results are to be scrutinized by SC and specialty sub-groups (including patient advocates) for truth, discrimination and feasibility - the OMERACT filters. Through application of Nominal Group technique, a core set of outcome measures will be proposed. Subsequent exercises will evaluate the applicability of a proposed core set to the unique issues posed by individual CTDs in addition to guidelines on screening, prognostication and damage scoring.

Eight-step method to build the clinical content of an evidence-based care pathway: the case for COPD exacerbation

PubMed Central

2012-01-01

Background Optimization of the clinical care process by integration of evidence-based knowledge is one of the active components in care pathways. When studying the impact of a care pathway by using a cluster-randomized design, standardization of the care pathway intervention is crucial. This methodology paper describes the development of the clinical content of an evidence-based care pathway for in-hospital management of chronic obstructive pulmonary disease (COPD) exacerbation in the context of a cluster-randomized controlled trial (cRCT) on care pathway effectiveness. Methods The clinical content of a care pathway for COPD exacerbation was developed based on recognized process design and guideline development methods. Subsequently, based on the COPD case study, a generalized eight-step method was designed to support the development of the clinical content of an evidence-based care pathway. Results A set of 38 evidence-based key interventions and a set of 24 process and 15 outcome indicators were developed in eight different steps. Nine Belgian multidisciplinary teams piloted both the set of key interventions and indicators. The key intervention set was judged by the teams as being valid and clinically applicable. In addition, the pilot study showed that the indicators were feasible for the involved clinicians and patients. Conclusions The set of 38 key interventions and the set of process and outcome indicators were found to be appropriate for the development and standardization of the clinical content of the COPD care pathway in the context of a cRCT on pathway effectiveness. The developed eight-step method may facilitate multidisciplinary teams caring for other patient populations in designing the clinical content of their future care pathways. PMID:23190552

Student nurse dyads create a community of learning: proposing a holistic clinical education theory.

PubMed

Ruth-Sahd, Lisa A

2011-11-01

This paper is a report of a qualitative study of students' experiences of cooperative learning in the clinical setting. Although cooperative learning is often used successfully in the classroom, it has not been documented in the clinical setting with sophomore nursing students being paired with other sophomore nursing students. Using a grounded theory methodology a sample of 64 participants (32 student nurse dyads, eight clinical groups, in two different acute care institutions) were observed on their first day in the clinical setting while working as cooperative partners. Interviews were also conducted with students, patients and staff preceptors. Data were collected in the fall of 2008, spring and fall of 2009 and the spring of 2010 using semi-structured interviews and reflective surveys. Data were analysed using the constant comparative method. A holistic clinical education theory for student nurses was identified from the data. This theory includes a reciprocal relationship among five categories relevant to a community of learning: supportive clinical experience; improved transition into practice; enhanced socialization into the profession; increased accountability and responsibility; and emergence of self-confidence as a beginning student nurse. The use of student dyads creates a supportive learning environment while students were able to meet the clinical learning objectives. Cooperative learning in the clinical setting creates a community of learning while instilling very early in the education process the importance of teamwork. This approach to clinical instruction eases the transition from the classroom to the clinical learning environment, and improves patient outcomes. © 2011 Blackwell Publishing Ltd.

EULAR/ACR classification criteria for adult and juvenile idiopathic inflammatory myopathies and their major subgroups: a methodology report

PubMed Central

Bottai, Matteo; Tjärnlund, Anna; Santoni, Giola; Werth, Victoria P; Pilkington, Clarissa; de Visser, Marianne; Alfredsson, Lars; Amato, Anthony A; Barohn, Richard J; Liang, Matthew H; Aggarwal, Rohit; Arnardottir, Snjolaug; Chinoy, Hector; Cooper, Robert G; Danko, Katalin; Dimachkie, Mazen M; Feldman, Brian M; García-De La Torre, Ignacio; Gordon, Patrick; Hayashi, Taichi; Katz, James D; Kohsaka, Hitoshi; Lachenbruch, Peter A; Lang, Bianca A; Li, Yuhui; Oddis, Chester V; Olesinka, Marzena; Reed, Ann M; Rutkowska-Sak, Lidia; Sanner, Helga; Selva-O’Callaghan, Albert; Wook Song, Yeong; Ytterberg, Steven R; Miller, Frederick W; Rider, Lisa G; Lundberg, Ingrid E; Amoruso, Maria

2017-01-01

Objective To describe the methodology used to develop new classification criteria for adult and juvenile idiopathic inflammatory myopathies (IIMs) and their major subgroups. Methods An international, multidisciplinary group of myositis experts produced a set of 93 potentially relevant variables to be tested for inclusion in the criteria. Rheumatology, dermatology, neurology and paediatric clinics worldwide collected data on 976 IIM cases (74% adults, 26% children) and 624 non-IIM comparator cases with mimicking conditions (82% adults, 18% children). The participating clinicians classified each case as IIM or non-IIM. Generally, the classification of any given patient was based on few variables, leaving remaining variables unmeasured. We investigated the strength of the association between all variables and between these and the disease status as determined by the physician. We considered three approaches: (1) a probability-score approach, (2) a sum-of-items approach criteria and (3) a classification-tree approach. Results The approaches yielded several candidate models that were scrutinised with respect to statistical performance and clinical relevance. The probability-score approach showed superior statistical performance and clinical practicability and was therefore preferred over the others. We developed a classification tree for subclassification of patients with IIM. A calculator for electronic devices, such as computers and smartphones, facilitates the use of the European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria. Conclusions The new EULAR/ACR classification criteria provide a patient’s probability of having IIM for use in clinical and research settings. The probability is based on a score obtained by summing the weights associated with a set of criteria items. PMID:29177080

A wavelet-based approach for a continuous analysis of phonovibrograms.

PubMed

Unger, Jakob; Meyer, Tobias; Doellinger, Michael; Hecker, Dietmar J; Schick, Bernhard; Lohscheller, Joerg

2012-01-01

Recently, endoscopic high-speed laryngoscopy has been established for commercial use and constitutes a state-of-the-art technique to examine vocal fold dynamics. Despite overcoming many limitations of commonly applied stroboscopy it has not gained widespread clinical application, yet. A major drawback is a missing methodology of extracting valuable features to support visual assessment or computer-aided diagnosis. In this paper a compact and descriptive feature set is presented. The feature extraction routines are based on two-dimensional color graphs called phonovibrograms (PVG). These graphs contain the full spatio-temporal pattern of vocal fold dynamics and are therefore suited to derive features that comprehensively describe the vibration pattern of vocal folds. Within our approach, clinically relevant features such as glottal closure type, symmetry and periodicity are quantified in a set of 10 descriptive features. The suitability for classification tasks is shown using a clinical data set comprising 50 healthy and 50 paralytic subjects. A classification accuracy of 93.2% has been achieved.

Challenges and opportunities of undertaking a video ethnographic study to understand medication communication.

PubMed

Liu, Wei; Gerdtz, Marie; Manias, Elizabeth

2015-12-01

To examine the challenges and opportunities of undertaking a video ethnographic study on medication communication among nurses, doctors, pharmacists and patients. Video ethnography has proved to be a dynamic and useful method to explore clinical communication activities. This approach involves filming actual behaviours and activities of clinicians to develop new knowledge and to stimulate reflections of clinicians on their behaviours and activities. However, there is limited information about the complex negotiations required to use video ethnography in actual clinical practice. Discursive paper. A video ethnographic approach was used to gain better understanding of medication communication processes in two general medical wards of a metropolitan hospital in Melbourne, Australia. This paper presents the arduous and delicate process of gaining access into hospital wards to video-record actual clinical practice and the methodological and ethical issues associated with video-recording. Obtaining access to clinical settings and clinician consent are the first hurdles of conducting a video ethnographic study. Clinicians may still feel intimidated or self-conscious in being video recorded about their medication communication practices, which they could perceive as judgements being passed about their clinical competence. By thoughtful and strategic planning, video ethnography can provide in-depth understandings of medication communication in acute care hospital settings. Ethical issues of informed consent, patient safety and respect for the confidentiality of patients and clinicians need to be carefully addressed to build up and maintain trusting relationships between researchers and participants in the clinical environment. By prudently considering the complex ethical and methodological concerns of using video ethnography, this approach can help to reveal the unpredictability and messiness of clinical practice. The visual data generated can stimulate clinicians' reflexivity about their norms of practice and bring about improved communication about managing medications. © 2015 John Wiley & Sons Ltd.

Demonstration of a software design and statistical analysis methodology with application to patient outcomes data sets

PubMed Central

Mayo, Charles; Conners, Steve; Warren, Christopher; Miller, Robert; Court, Laurence; Popple, Richard

2013-01-01

Purpose: With emergence of clinical outcomes databases as tools utilized routinely within institutions, comes need for software tools to support automated statistical analysis of these large data sets and intrainstitutional exchange from independent federated databases to support data pooling. In this paper, the authors present a design approach and analysis methodology that addresses both issues. Methods: A software application was constructed to automate analysis of patient outcomes data using a wide range of statistical metrics, by combining use of C#.Net and R code. The accuracy and speed of the code was evaluated using benchmark data sets. Results: The approach provides data needed to evaluate combinations of statistical measurements for ability to identify patterns of interest in the data. Through application of the tools to a benchmark data set for dose-response threshold and to SBRT lung data sets, an algorithm was developed that uses receiver operator characteristic curves to identify a threshold value and combines use of contingency tables, Fisher exact tests, Welch t-tests, and Kolmogorov-Smirnov tests to filter the large data set to identify values demonstrating dose-response. Kullback-Leibler divergences were used to provide additional confirmation. Conclusions: The work demonstrates the viability of the design approach and the software tool for analysis of large data sets. PMID:24320426

Demonstration of a software design and statistical analysis methodology with application to patient outcomes data sets.

PubMed

Mayo, Charles; Conners, Steve; Warren, Christopher; Miller, Robert; Court, Laurence; Popple, Richard

2013-11-01

With emergence of clinical outcomes databases as tools utilized routinely within institutions, comes need for software tools to support automated statistical analysis of these large data sets and intrainstitutional exchange from independent federated databases to support data pooling. In this paper, the authors present a design approach and analysis methodology that addresses both issues. A software application was constructed to automate analysis of patient outcomes data using a wide range of statistical metrics, by combining use of C#.Net and R code. The accuracy and speed of the code was evaluated using benchmark data sets. The approach provides data needed to evaluate combinations of statistical measurements for ability to identify patterns of interest in the data. Through application of the tools to a benchmark data set for dose-response threshold and to SBRT lung data sets, an algorithm was developed that uses receiver operator characteristic curves to identify a threshold value and combines use of contingency tables, Fisher exact tests, Welch t-tests, and Kolmogorov-Smirnov tests to filter the large data set to identify values demonstrating dose-response. Kullback-Leibler divergences were used to provide additional confirmation. The work demonstrates the viability of the design approach and the software tool for analysis of large data sets.

Using clinical journaling to capture critical thinking across the curriculum.

PubMed

Ruthman, Jacklyn; Jackson, Janet; Cluskey, Maureen; Flannigan, Peggy; Folse, Victoria N; Bunten, Jo

2004-01-01

Clinical journaling is used as an integrated teaching methodology throughout the practicum component of a baccalaureate nursing curriculum. Two disciplines, Nursing and English, collaborated to develop clinical journaling guidelines to provide a consistent framework for student learning and evaluation in a variety of clinical settings. Students complete a weekly log for each clinical rotation. They identify learning goals, analyze events and relate them to nursing practice, use critical thinking to connect theory and practice, and reflect on the experience.A collegiate standard of writing is used. As the student advances through the program, a pattern of accomplishments and a cumulative integration of skills is evidenced to provide consistent standards for student evaluation.

Incorporating scenario-based simulation into a hospital nursing education program.

PubMed

Nagle, Beth M; McHale, Jeanne M; Alexander, Gail A; French, Brian M

2009-01-01

Nurse educators are challenged to provide meaningful and effective learning opportunities for both new and experienced nurses. Simulation as a teaching and learning methodology is being embraced by nursing in academic and practice settings to provide innovative educational experiences to assess and develop clinical competency, promote teamwork, and improve care processes. This article provides an overview of the historical basis for using simulation in education, simulation methodologies, and perceived advantages and disadvantages. It also provides a description of the integration of scenario-based programs using a full-scale patient simulator into nursing education programming at a large academic medical center.

A core outcome set for clinical trials in acute diarrhoea.

PubMed

Karas, Jacek; Ashkenazi, Shai; Guarino, Alfredo; Lo Vecchio, Andrea; Shamir, Raanan; Vandenplas, Yvan; Szajewska, Hania

2015-04-01

Core outcome sets are the baseline for what should be measured in clinical research and, thus, should serve as a guide for what should be collected and reported. The Consensus Group on Outcome Measures Made in Pediatric Enteral Nutrition Clinical Trials, established in 2012, agreed that consensus on a core set of outcomes with agreed-upon definitions that should be measured and reported in clinical trials was needed. To achieve this goal, six working groups (WGs) were setup, including WG on acute diarrhoea, whose main goal was to develop a core outcome set for trials in acute diarrhoea. The first step identified how published outcomes related to acute diarrhoea were reported. The second focused on the methodology for determining which outcomes to measure in clinical trials. The third employed a two-phase questionnaire study using the Delphi technique to define clinically important outcomes to clinicians and parents. For therapeutic studies, the five most important outcome measures were diarrhoea duration, degree of dehydration, need for hospitalisation (or duration of hospitalisation for inpatients), the proportion of patients recovered by 48 h and adverse effects. The prophylactic core outcome set included prevention of diarrhoea, prevention of dehydration, prevention of hospitalisation and adverse effects. The outcome sets for therapy and prevention can be recommended for use in future trials of patients with gastroenteritis. Their envisioned goal is to decrease study heterogeneity and to ease the comparability of studies. WG's next step is to determine how to measure the outcomes included in the core set. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Assessing data quality and the variability of source data verification auditing methods in clinical research settings.

PubMed

Houston, Lauren; Probst, Yasmine; Martin, Allison

2018-05-18

Data audits within clinical settings are extensively used as a major strategy to identify errors, monitor study operations and ensure high-quality data. However, clinical trial guidelines are non-specific in regards to recommended frequency, timing and nature of data audits. The absence of a well-defined data quality definition and method to measure error undermines the reliability of data quality assessment. This review aimed to assess the variability of source data verification (SDV) auditing methods to monitor data quality in a clinical research setting. The scientific databases MEDLINE, Scopus and Science Direct were searched for English language publications, with no date limits applied. Studies were considered if they included data from a clinical trial or clinical research setting and measured and/or reported data quality using a SDV auditing method. In total 15 publications were included. The nature and extent of SDV audit methods in the articles varied widely, depending upon the complexity of the source document, type of study, variables measured (primary or secondary), data audit proportion (3-100%) and collection frequency (6-24 months). Methods for coding, classifying and calculating error were also inconsistent. Transcription errors and inexperienced personnel were the main source of reported error. Repeated SDV audits using the same dataset demonstrated ∼40% improvement in data accuracy and completeness over time. No description was given in regards to what determines poor data quality in clinical trials. A wide range of SDV auditing methods are reported in the published literature though no uniform SDV auditing method could be determined for "best practice" in clinical trials. Published audit methodology articles are warranted for the development of a standardised SDV auditing method to monitor data quality in clinical research settings. Copyright © 2018. Published by Elsevier Inc.

The medical educator, the discourse analyst, and the phonetician: a collaborative feedback methodology for clinical communication.

PubMed

Woodward-Kron, Robyn; Stevens, Mary; Flynn, Eleanor

2011-05-01

Frameworks for clinical communication assist educators in making explicit the principles of good communication and providing feedback to medical trainees. However, existing frameworks rarely take into account the roles of culture and language in communication, which can be important for international medical graduates (IMGs) whose first language is not English. This article describes the collaboration by a medical educator, a discourse analyst, and a phonetician to develop a communication and language feedback methodology to assist IMG trainees at a Victorian hospital in Australia with developing their doctor-patient communication skills. The Communication and Language Feedback (CaLF) methodology incorporates a written tool and video recording of role-plays of doctor-patient interactions in a classroom setting or in an objective structured clinical examination (OSCE) practice session with a simulated patient. IMG trainees receive verbal feedback from their hospital-based medical clinical educator, the simulated patient, and linguists. The CaLF tool was informed by a model of language in context, observation of IMG communication training, and process evaluation by IMG participants during January to August 2009. The authors provided participants with a feedback package containing their practice video (which included verbal feedback) and the completed CaLF tool.The CaLF methodology provides a tool for medical educators and language practitioners to work collaboratively with IMGs to enhance communication and language skills. The ongoing interdisciplinary collaboration also provides much-needed applied research opportunities in intercultural health communication, an area the authors believe cannot be adequately addressed from the perspective of one discipline alone. Copyright © by the Association of American medical Colleges.

Lean methodology improves efficiency in outpatient academic uro-oncology clinics.

PubMed

Skeldon, Sean C; Simmons, Andrea; Hersey, Karen; Finelli, Antonio; Jewett, Michael A; Zlotta, Alexandre R; Fleshner, Neil E

2014-05-01

To determine if lean methodology, an industrial engineering tool developed to optimize manufacturing efficiency, can successfully be applied to improve efficiencies and quality of care in a hospital-based high-volume uro-oncology clinic. Before the lean initiative, baseline data were collected on patient volumes, wait times, cycle times (patient arrival to discharge), nursing assessment time, patient teaching, and physician ergonomics (via spaghetti diagram). Value stream analysis and a rapid improvement event were carried out, and significant changes were made to patient check-in, work areas, and nursing face time. Follow-up data were obtained at 30, 60, and 90 days. The Student t test was used for analysis to compare performance metrics with baseline. The median cycle time before the lean initiative was 46 minutes. This remained stable at 46 minutes at 30 days but improved to 35 minutes at 60 days and 41 minutes at 90 days. Shorter wait times allowed for increased nursing and physician face time. The average length of the physician assessment increased from 7.5 minutes at baseline to 10.6 minutes at 90 days. The average proportion of value-added time compared with the entire clinic visit increased from 30.6% at baseline to 66.3% at 90 days. Using lean methodology, we were able to shorten the patient cycle time and the time to initial assessment as well as integrate both an initial registered nurse assessment and registered nurse teaching to each visit. Lean methodology can effectively be applied to improve efficiency and patient care in an academic outpatient uro-oncology clinic setting. Copyright © 2014 Elsevier Inc. All rights reserved.

phMRI: methodological considerations for mitigating potential confounding factors

PubMed Central

Bourke, Julius H.; Wall, Matthew B.

2015-01-01

Pharmacological Magnetic Resonance Imaging (phMRI) is a variant of conventional MRI that adds pharmacological manipulations in order to study the effects of drugs, or uses pharmacological probes to investigate basic or applied (e.g., clinical) neuroscience questions. Issues that may confound the interpretation of results from various types of phMRI studies are briefly discussed, and a set of methodological strategies that can mitigate these problems are described. These include strategies that can be employed at every stage of investigation, from study design to interpretation of resulting data, and additional techniques suited for use with clinical populations are also featured. Pharmacological MRI is a challenging area of research that has both significant advantages and formidable difficulties, however with due consideration and use of these strategies many of the key obstacles can be overcome. PMID:25999812

The ethics of placebo-controlled trials: methodological justifications.

PubMed

Millum, Joseph; Grady, Christine

2013-11-01

The use of placebo controls in clinical trials remains controversial. Ethical analysis and international ethical guidance permit the use of placebo controls in randomized trials when scientifically indicated in four cases: (1) when there is no proven effective treatment for the condition under study; (2) when withholding treatment poses negligible risks to participants; (3) when there are compelling methodological reasons for using placebo, and withholding treatment does not pose a risk of serious harm to participants; and, more controversially, (4) when there are compelling methodological reasons for using placebo, and the research is intended to develop interventions that can be implemented in the population from which trial participants are drawn, and the trial does not require participants to forgo treatment they would otherwise receive. The concept of methodological reasons is essential to assessing the ethics of placebo controls in these controversial last two cases. This article sets out key considerations relevant to considering whether methodological reasons for a placebo control are compelling. © 2013.

[Artificial intelligence to assist clinical diagnosis in medicine].

PubMed

Lugo-Reyes, Saúl Oswaldo; Maldonado-Colín, Guadalupe; Murata, Chiharu

2014-01-01

Medicine is one of the fields of knowledge that would most benefit from a closer interaction with Computer studies and Mathematics by optimizing complex, imperfect processes such as differential diagnosis; this is the domain of Machine Learning, a branch of Artificial Intelligence that builds and studies systems capable of learning from a set of training data, in order to optimize classification and prediction processes. In Mexico during the last few years, progress has been made on the implementation of electronic clinical records, so that the National Institutes of Health already have accumulated a wealth of stored data. For those data to become knowledge, they need to be processed and analyzed through complex statistical methods, as it is already being done in other countries, employing: case-based reasoning, artificial neural networks, Bayesian classifiers, multivariate logistic regression, or support vector machines, among other methodologies; to assist the clinical diagnosis of acute appendicitis, breast cancer and chronic liver disease, among a wide array of maladies. In this review we shift through concepts, antecedents, current examples and methodologies of machine learning-assisted clinical diagnosis.

Integrating cost information with health management support system: an enhanced methodology to assess health care quality drivers.

PubMed

Kohli, R; Tan, J K; Piontek, F A; Ziege, D E; Groot, H

1999-08-01

Changes in health care delivery, reimbursement schemes, and organizational structure have required health organizations to manage the costs of providing patient care while maintaining high levels of clinical and patient satisfaction outcomes. Today, cost information, clinical outcomes, and patient satisfaction results must become more fully integrated if strategic competitiveness and benefits are to be realized in health management decision making, especially in multi-entity organizational settings. Unfortunately, traditional administrative and financial systems are not well equipped to cater to such information needs. This article presents a framework for the acquisition, generation, analysis, and reporting of cost information with clinical outcomes and patient satisfaction in the context of evolving health management and decision-support system technology. More specifically, the article focuses on an enhanced costing methodology for determining and producing improved, integrated cost-outcomes information. Implementation issues and areas for future research in cost-information management and decision-support domains are also discussed.

CONCEPTUAL AND METHODOLOGICAL ISSUES IN DESIGNING A RANDOMIZED CONTROLLED TREATMENT TRIAL FOR GERIATRIC BIPOLAR DISORDER: GERI-BD

PubMed Central

Young, Robert C.; Schulberg, Herbert C.; Gildengers, Ariel G.; Sajatovic, Martha; Mulsant, Benoit H.; Gyulai, Laszlo; Beyer, John; Marangell, Lauren; Kunik, Mark; Have, Thomas Ten; Bruce, Martha L.; Gur, Ruben; Marino, Patricia; Evans, Jovier D.; Reynolds, Charles F.; Alexopoulos, George S.

2010-01-01

Aim This report considers the conceptual and methodological concerns confronting clinical investigators seeking to generate knowledge regarding the tolerability and benefits of pharmacotherapy in geriatric bipolar (BP) patients. Method There is continuing need for evidence-based guidelines derived from randomized controlled trials that will enhance drug treatment of geriatric BP patients. We, therefore, present the complex conceptual and methodological choices encountered in designing a multi-site clinical trial and the decisions reached by the investigators with the intention that study findings are pertinent to, and can facilitate, routine treatment decisions. Results Guided by a literature review and input from peers, the tolerability and anti-manic effect of lithium and valproate were judged to be the key mood stabilizers to investigate with regard to treating BP I manic, mixed and hypomanic states. The patient selection criteria are intended to generate a sample that experiences common treatment needs but which also represents the variety of older patients seen in university-based clinical settings. The clinical protocol guides titratation of lithium and valproate to target serum concentrations, with lower levels allowed when necessitated by limited tolerability. The protocol emphasizes initial monotherapy. However, augmentation with risperidone is permitted after three weeks when indicated by operational criteria. Conclusions A randomized controlled trial that both investigates commonly prescribed mood stabilizers and maximizes patient participation can meaningfully address high priority clinical concerns directly relevant to the routine pharmacologic treatment of geriatric BP patients. PMID:20148867

Salud Para Su Corazon (health for your heart) community health worker model: community and clinical approaches for addressing cardiovascular disease risk reduction in Hispanics/Latinos.

PubMed

Balcazar, H; Alvarado, M; Ortiz, G

2011-01-01

This article describes 6 Salud Para Su Corazon (SPSC) family of programs that have addressed cardiovascular disease risk reduction in Hispanic communities facilitated by community health workers (CHWs) or Promotores de Salud (PS). A synopsis of the programs illustrates the designs and methodological approaches that combine community-based participatory research for 2 types of settings: community and clinical. Examples are provided as to how CHWs can serve as agents of change in these settings. A description is presented of a sustainability framework for the SPSC family of programs. Finally, implications are summarized for utilizing the SPSC CHW/PS model to inform ambulatory care management and policy.

Activity-based costs of plasma transfusions in medical and surgical inpatients at a US hospital.

PubMed

Shander, A; Ozawa, S; Hofmann, A

2016-07-01

Fresh frozen plasma (FFP) usage has significantly increased over the last decade leading to elevated healthcare costs. Although FFP is used in several clinical settings, it is often inappropriately transfused and evidence for its clinical efficacy is poor. Here, we describe plasma usage and transfusion costs in a real-world US inpatient setting to determine the cost-effectiveness of FFP transfusion and for comparison to various patient blood management (PBM) options to treat coagulopathies. All activities related to plasma transfusion recorded at a single US hospital over one calendar year were collected in a stepwise manner using an activity-based costing (ABC) methodology. This model maps all technical, administrative and clinical processes inherent to the cost of plasma. Of 18 200 inpatients recorded, 849 were charged for blood products. In total, 136 medical and surgical inpatients were charged for 577 units of FFP, receiving a total of 534 units; 43 units were charged but not transfused. The total cost per unit of FFP transfused was $409·62 and $1,608·37 per patient transfused with FFP. Wasted products, in-hospital processes and overhead costs were found to account for 89·8% of the total cost of FFP transfusions. This study is the first to use ABC methodology to determine the full cost of plasma transfusion in a US inpatient setting. These data reveal the true cost of plasma, providing a useful reference point to compare with the cost of other PBM options to manage coagulation disorders. © 2016 International Society of Blood Transfusion.

The Harmonizing Outcome Measures for Eczema (HOME) roadmap: a methodological framework to develop core sets of outcome measurements in dermatology.

PubMed

Schmitt, Jochen; Apfelbacher, Christian; Spuls, Phyllis I; Thomas, Kim S; Simpson, Eric L; Furue, Masutaka; Chalmers, Joanne; Williams, Hywel C

2015-01-01

Core outcome sets (COSs) are consensus-derived minimum sets of outcomes to be assessed in a specific situation. COSs are being increasingly developed to limit outcome-reporting bias, allow comparisons across trials, and strengthen clinical decision making. Despite the increasing interest in outcomes research, methods to develop COSs have not yet been standardized. The aim of this paper is to present the Harmonizing Outcomes Measures for Eczema (HOME) roadmap for the development and implementation of COSs, which was developed on the basis of our experience in the standardization of outcome measurements for atopic eczema. Following the establishment of a panel representing all relevant stakeholders and a research team experienced in outcomes research, the scope and setting of the core set should be defined. The next steps are the definition of a core set of outcome domains such as symptoms or quality of life, followed by the identification or development and validation of appropriate outcome measurement instruments to measure these core domains. Finally, the consented COS needs to be disseminated, implemented, and reviewed. We believe that the HOME roadmap is a useful methodological framework to develop COSs in dermatology, with the ultimate goal of better decision making and promoting patient-centered health care.

Developing a science of clinical utility in diagnostic classification systems field study strategies for ICD-11 mental and behavioral disorders.

PubMed

Keeley, Jared W; Reed, Geoffrey M; Roberts, Michael C; Evans, Spencer C; Medina-Mora, María Elena; Robles, Rebeca; Rebello, Tahilia; Sharan, Pratap; Gureje, Oye; First, Michael B; Andrews, Howard F; Ayuso-Mateos, José Luís; Gaebel, Wolfgang; Zielasek, Juergen; Saxena, Shekhar

2016-01-01

The World Health Organization (WHO) Department of Mental Health and Substance Abuse has developed a systematic program of field studies to evaluate and improve the clinical utility of the proposed diagnostic guidelines for mental and behavioral disorders in the Eleventh Revision of the International Classification of Diseases and Related Health Problems (ICD-11). The clinical utility of a diagnostic classification is critical to its function as the interface between health encounters and health information, and to making the ICD-11 be a more effective tool for helping the WHO's 194 member countries, including the United States, reduce the global disease burden of mental disorders. This article describes the WHO's efforts to develop a science of clinical utility in regard to one of the two major classification systems for mental disorders. We present the rationale and methodologies for an integrated and complementary set of field study strategies, including large international surveys, formative field studies of the structure of clinicians' conceptualization of mental disorders, case-controlled field studies using experimental methodologies to evaluate the impact of proposed changes to the diagnostic guidelines on clinicians' diagnostic decision making, and ecological implementation field studies of clinical utility in the global settings in which the guidelines will ultimately be implemented. The results of these studies have already been used in making decisions about the structure and content of ICD-11. If clinical utility is indeed among the highest aims of diagnostic systems for mental disorders, as their developers routinely claim, future revision efforts should continue to build on these efforts. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Core outcome sets in dermatology: report from the second meeting of the International Cochrane Skin Group Core Outcome Set Initiative.

PubMed

Kottner, J; Jacobi, L; Hahnel, E; Alam, M; Balzer, K; Beeckman, D; Busard, C; Chalmers, J; Deckert, S; Eleftheriadou, V; Furlan, K; Horbach, S E R; Kirkham, J; Nast, A; Spuls, P; Thiboutot, D; Thorlacius, L; Weller, K; Williams, H C; Schmitt, J

2018-04-01

Results of clinical trials are the most important information source for generating external clinical evidence. The use of different outcomes across trials, which investigate similar interventions for similar patient groups, significantly limits the interpretation, comparability and clinical application of trial results. Core outcome sets (COSs) aim to overcome this limitation. A COS is an agreed standardized collection of outcomes that should be measured and reported in all clinical trials for a specific clinical condition. The Core Outcome Set Initiative within the Cochrane Skin Group (CSG-COUSIN) supports the development of core outcomes in dermatology. In the second CSG-COUSIN meeting held in 2017, 11 COS development groups working on skin diseases presented their current work. The presentations and discussions identified the following overarching methodological challenges for COS development in dermatology: it is not always easy to define the disease focus of a COS; the optimal method for outcome domain identification and level of detail needed to specify such domains is challenging to many; decision rules within Delphi surveys need to be improved; appropriate ways of patient involvement are not always clear. In addition, there appear to be outcome domains that may be relevant as potential core outcome domains for the majority of skin diseases. The close collaboration between methodologists in the Core Outcome Set Initiative and the international Cochrane Skin Group has major advantages for trialists, systematic reviewers and COS developers. © 2018 British Association of Dermatologists.

Rare Cancers Europe (RCE) methodological recommendations for clinical studies in rare cancers: a European consensus position paper.

PubMed

Casali, P G; Bruzzi, P; Bogaerts, J; Blay, J-Y

2015-02-01

While they account for one-fifth of new cancer cases, rare cancers are difficult to study. A higher than average degree of uncertainty should be accommodated for clinical as well as for population-based decision making. Rules of rational decision making in conditions of uncertainty should be rigorously followed and would need widely informative clinical trials. In principle, any piece of new evidence would need to be exploited in rare cancers. Methodologies to explicitly weigh and combine all the available evidence should be refined, and the Bayesian logic can be instrumental to this end. Likewise, Bayesian-design trials may help optimize the low number of patients liable to be enrolled in clinical studies on rare cancers, as well as adaptive trials in general, with their inherent potential of flexibility when properly applied. While clinical studies are the mainstay to test hypotheses, the potential of electronic patient records should be exploited to generate new hypotheses, to create external controls for future studies (when internal controls are unpractical), to study effectiveness of new treatments in real conditions. Framework study protocols in specific rare cancers to sequentially test sets of new agents, as from the early post-phase I development stage, should be encouraged. Also the compassionate and the off-label settings should be exploited to generate new evidence, and flexible regulatory innovations such as adaptive licensing could convey new agents early to rare cancer patients, while generating evidence. Though validation of surrogate end points is problematic in rare cancers, the use of an updated notion of tumor response may be of great value in the single patient to optimize the use of therapies, all the more the new ones. Disease-based communities, involving clinicians and patients, should be regularly consulted by regulatory bodies when setting their policies on drug approval and reimbursement in specific rare cancers. © The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology.

Methodological aspects of multicenter studies with quantitative PET.

PubMed

Boellaard, Ronald

2011-01-01

Quantification of whole-body FDG PET studies is affected by many physiological and physical factors. Much of the variability in reported standardized uptake value (SUV) data seen in the literature results from the variability in methodology applied among these studies, i.e., due to the use of different scanners, acquisition and reconstruction settings, region of interest strategies, SUV normalization, and/or corrections methods. To date, the variability in applied methodology prohibits a proper comparison and exchange of quantitative FDG PET data. Consequently, the promising role of quantitative PET has been demonstrated in several monocentric studies, but these published results cannot be used directly as a guideline for clinical (multicenter) trials performed elsewhere. In this chapter, the main causes affecting whole-body FDG PET quantification and strategies to minimize its inter-institute variability are addressed.

Feature extraction across individual time series observations with spikes using wavelet principal component analysis.

PubMed

Røislien, Jo; Winje, Brita

2013-09-20

Clinical studies frequently include repeated measurements of individuals, often for long periods. We present a methodology for extracting common temporal features across a set of individual time series observations. In particular, the methodology explores extreme observations within the time series, such as spikes, as a possible common temporal phenomenon. Wavelet basis functions are attractive in this sense, as they are localized in both time and frequency domains simultaneously, allowing for localized feature extraction from a time-varying signal. We apply wavelet basis function decomposition of individual time series, with corresponding wavelet shrinkage to remove noise. We then extract common temporal features using linear principal component analysis on the wavelet coefficients, before inverse transformation back to the time domain for clinical interpretation. We demonstrate the methodology on a subset of a large fetal activity study aiming to identify temporal patterns in fetal movement (FM) count data in order to explore formal FM counting as a screening tool for identifying fetal compromise and thus preventing adverse birth outcomes. Copyright © 2013 John Wiley & Sons, Ltd.

Studies in Ambulatory Care Quality Assessment in the Indian Health Service. Volume II: Appraisal of System Performance.

ERIC Educational Resources Information Center

Nutting, Paul A.; And Others

Six Indian Health Service (IHS) units, chosen in a non-random manner, were evaluated via a quality assessment methodology currently under development by the IHS Office of Research and Development. A set of seven health problems (tracers) was selected to represent major health problems, and clinical algorithms (process maps) were constructed for…

Evaluating the Well-Being of Public Library Workers

ERIC Educational Resources Information Center

Juniper, Bridget; Bellamy, Pat; White, Nicola

2012-01-01

This study aimed to develop and pilot a questionnaire to determine the ways in which working in a UK public library system can impact the well-being of those deployed in the sector. The methodological framework was based on an approach used to evaluate the well-being of patients in a clinical setting. Based on the responses of 466 employees, the…

JPRS Report, Science & Technology. Europe: Economic Competitiveness

DTIC Science & Technology

1992-02-24

Health Systems This area covers the harmonisation of methodologies and protocols in epidemiological, biological , clinical and technological...substances and biological agents on human health; and the application and enhancement of biomedical tech- nology to medical health care. Major Health...Work will cover the completion and integration of the genetic and physical maps; the genetic basis for biolog - ical functions; and the setting up a

Surgical simulation training in orthopedics: current insights.

PubMed

Kalun, Portia; Wagner, Natalie; Yan, James; Nousiainen, Markku T; Sonnadara, Ranil R

2018-01-01

While the knowledge required of residents training in orthopedic surgery continues to increase, various factors, including reductions in work hours, have resulted in decreased clinical learning opportunities. Recent work suggests residents graduate from their training programs without sufficient exposure to key procedures. In response, simulation is increasingly being incorporated into training programs to supplement clinical learning. This paper reviews the literature to explore whether skills learned in simulation-based settings results in improved clinical performance in orthopedic surgery trainees. A scoping review of the literature was conducted to identify papers discussing simulation training in orthopedic surgery. We focused on exploring whether skills learned in simulation transferred effectively to a clinical setting. Experimental studies, systematic reviews, and narrative reviews were included. A total of 15 studies were included, with 11 review papers and four experimental studies. The review articles reported little evidence regarding the transfer of skills from simulation to the clinical setting, strong evidence that simulator models discriminate among different levels of experience, varied outcome measures among studies, and a need to define competent performance in both simulated and clinical settings. Furthermore, while three out of the four experimental studies demonstrated transfer between the simulated and clinical environments, methodological study design issues were identified. Our review identifies weak evidence as to whether skills learned in simulation transfer effectively to clinical practice for orthopedic surgery trainees. Given the increased reliance on simulation, there is an immediate need for comprehensive studies that focus on skill transfer, which will allow simulation to be incorporated effectively into orthopedic surgery training programs.

Molecular classification and molecular forecasting of breast cancer: ready for clinical application?

PubMed

Brenton, James D; Carey, Lisa A; Ahmed, Ahmed Ashour; Caldas, Carlos

2005-10-10

Profiling breast cancer with expression arrays has become common, and it has been suggested that the results from early studies will lead to understanding of the molecular differences between clinical cases and allow individualization of care. We critically review two main applications of expression profiling; studies unraveling novel breast cancer classifications and those that aim to identify novel markers for prediction of clinical outcome. Breast cancer may now be subclassified into luminal, basal, and HER2 subtypes with distinct differences in prognosis and response to therapy. However, profiling studies to identify predictive markers have suffered from methodologic problems that prevent general application of their results. Future work will need to reanalyze existing microarray data sets to identify more representative sets of candidate genes for use as prognostic signatures and will need to take into account the new knowledge of molecular subtypes of breast cancer when assessing predictive effects.

Best evidence on the educational effects of undergraduate portfolios.

PubMed

Buckley, Sharon; Coleman, Jamie; Khan, Khalid

2010-09-01

The great variety of portfolio types and schemes used in the education of health professionals is reflected in the extensive and diverse educational literature relating to portfolio use. We have recently completed a Best Evidence Medical Education (BEME) systematic review of the literature relating to the use of portfolios in the undergraduate setting that offers clinical teachers insights into both their effects on learning and issues to consider in portfolio implementation. Using a methodology based on BEME recommendations, we searched the literature relating to a range of health professions, identifying evidence for the effects of portfolios on undergraduate student learning, and assessing the methodological quality of each study. The higher quality studies in our review report that, when implemented appropriately, portfolios can improve students' ability to integrate theory with practice, can encourage their self-awareness and reflection, and can offer support for students facing difficult emotional situations. Portfolios can also enhance student-tutor relationships and prepare students for the rigours of postgraduate training. However, the time required to complete a portfolio may detract from students' clinical learning. An analysis of methodological quality against year of publication suggests that, across a range of health professions, the quality of the literature relating to the educational effects of portfolios is improving. However, further work is still required to build the evidence base for the educational effects of portfolios, particularly comparative studies that assess effects on learning directly. Our findings have implications for the design and implementation of portfolios in the undergraduate setting. © Blackwell Publishing Ltd 2010.

A Mixed-Methods Research Framework for Healthcare Process Improvement.

PubMed

Bastian, Nathaniel D; Munoz, David; Ventura, Marta

2016-01-01

The healthcare system in the United States is spiraling out of control due to ever-increasing costs without significant improvements in quality, access to care, satisfaction, and efficiency. Efficient workflow is paramount to improving healthcare value while maintaining the utmost standards of patient care and provider satisfaction in high stress environments. This article provides healthcare managers and quality engineers with a practical healthcare process improvement framework to assess, measure and improve clinical workflow processes. The proposed mixed-methods research framework integrates qualitative and quantitative tools to foster the improvement of processes and workflow in a systematic way. The framework consists of three distinct phases: 1) stakeholder analysis, 2a) survey design, 2b) time-motion study, and 3) process improvement. The proposed framework is applied to the pediatric intensive care unit of the Penn State Hershey Children's Hospital. The implementation of this methodology led to identification and categorization of different workflow tasks and activities into both value-added and non-value added in an effort to provide more valuable and higher quality patient care. Based upon the lessons learned from the case study, the three-phase methodology provides a better, broader, leaner, and holistic assessment of clinical workflow. The proposed framework can be implemented in various healthcare settings to support continuous improvement efforts in which complexity is a daily element that impacts workflow. We proffer a general methodology for process improvement in a healthcare setting, providing decision makers and stakeholders with a useful framework to help their organizations improve efficiency. Published by Elsevier Inc.

Patient Safety Competence of Nursing Students in Saudi Arabia: A Self-Reported Survey

PubMed Central

Colet, Paolo C.; Cruz, Jonas P.; Cruz, Charlie P.; Al-otaibi, Jazi; Qubeilat, Hikmet; Alquwez, Nahed

2015-01-01

Objective With the growing recognition of the significance of patient safety (PS) in educational institutions and health organizations, it is essential to understand the perspective of nursing students on their own PS competence. This study analyzed the self-reported PS competence of nursing students at a government university in Saudi Arabia. Methodology A cross-sectional self-reported survey of 191 respondents, using the Health Professional Education in Patient Safety Survey (H-PEPSS) was conducted. The survey tool reflected 6 key socio-cultural dimensions assessing competence in classroom and clinical setting. Results Female nursing students reported higher PS competence in both the classroom and clinical settings along the dimensions ‘working in teams’ and ‘communicating effectively’ while males reported higher competence in both settings as to the ‘managing safety risks’ and ‘understanding human and environmental factors’ dimensions. The respondents’ academic level and self–reported PS competence have weak negative correlation in the classroom while a strong negative correlation between the 2 variables existed in the clinical setting. Self-reported PS competence for the dimensions ‘working in teams’, ‘recognize and respond to remove immediate risks of harm’, and ‘culture of safety’ is significantly higher in classroom than in the clinical setting. Conclusion Generally, the Saudi nursing students reported varying levels of competence in the six dimensions of patient safety. Significant gap between the perceived PS competence was observed between learning settings. Educational and training interventions are suggested for implementation to bridge this gap. PMID:26715921

Predictions of CD4 lymphocytes’ count in HIV patients from complete blood count

PubMed Central

2013-01-01

Background HIV diagnosis, prognostic and treatment requires T CD4 lymphocytes’ number from flow cytometry, an expensive technique often not available to people in developing countries. The aim of this work is to apply a previous developed methodology that predicts T CD4 lymphocytes’ value based on total white blood cell (WBC) count and lymphocytes count applying sets theory, from information taken from the Complete Blood Count (CBC). Methods Sets theory was used to classify into groups named A, B, C and D the number of leucocytes/mm3, lymphocytes/mm3, and CD4/μL3 subpopulation per flow cytometry of 800 HIV diagnosed patients. Union between sets A and C, and B and D were assessed, and intersection between both unions was described in order to establish the belonging percentage to these sets. Results were classified into eight ranges taken by 1000 leucocytes/mm3, calculating the belonging percentage of each range with respect to the whole sample. Results Intersection (A ∪ C) ∩ (B ∪ D) showed an effectiveness in the prediction of 81.44% for the range between 4000 and 4999 leukocytes, 91.89% for the range between 3000 and 3999, and 100% for the range below 3000. Conclusions Usefulness and clinical applicability of a methodology based on sets theory were confirmed to predict the T CD4 lymphocytes’ value, beginning with WBC and lymphocytes’ count from CBC. This methodology is new, objective, and has lower costs than the flow cytometry which is currently considered as Gold Standard. PMID:24034560

A framework for quantifying net benefits of alternative prognostic models.

PubMed

Rapsomaniki, Eleni; White, Ian R; Wood, Angela M; Thompson, Simon G

2012-01-30

New prognostic models are traditionally evaluated using measures of discrimination and risk reclassification, but these do not take full account of the clinical and health economic context. We propose a framework for comparing prognostic models by quantifying the public health impact (net benefit) of the treatment decisions they support, assuming a set of predetermined clinical treatment guidelines. The change in net benefit is more clinically interpretable than changes in traditional measures and can be used in full health economic evaluations of prognostic models used for screening and allocating risk reduction interventions. We extend previous work in this area by quantifying net benefits in life years, thus linking prognostic performance to health economic measures; by taking full account of the occurrence of events over time; and by considering estimation and cross-validation in a multiple-study setting. The method is illustrated in the context of cardiovascular disease risk prediction using an individual participant data meta-analysis. We estimate the number of cardiovascular-disease-free life years gained when statin treatment is allocated based on a risk prediction model with five established risk factors instead of a model with just age, gender and region. We explore methodological issues associated with the multistudy design and show that cost-effectiveness comparisons based on the proposed methodology are robust against a range of modelling assumptions, including adjusting for competing risks. Copyright © 2011 John Wiley & Sons, Ltd.

A framework for quantifying net benefits of alternative prognostic models‡

PubMed Central

Rapsomaniki, Eleni; White, Ian R; Wood, Angela M; Thompson, Simon G

2012-01-01

New prognostic models are traditionally evaluated using measures of discrimination and risk reclassification, but these do not take full account of the clinical and health economic context. We propose a framework for comparing prognostic models by quantifying the public health impact (net benefit) of the treatment decisions they support, assuming a set of predetermined clinical treatment guidelines. The change in net benefit is more clinically interpretable than changes in traditional measures and can be used in full health economic evaluations of prognostic models used for screening and allocating risk reduction interventions. We extend previous work in this area by quantifying net benefits in life years, thus linking prognostic performance to health economic measures; by taking full account of the occurrence of events over time; and by considering estimation and cross-validation in a multiple-study setting. The method is illustrated in the context of cardiovascular disease risk prediction using an individual participant data meta-analysis. We estimate the number of cardiovascular-disease-free life years gained when statin treatment is allocated based on a risk prediction model with five established risk factors instead of a model with just age, gender and region. We explore methodological issues associated with the multistudy design and show that cost-effectiveness comparisons based on the proposed methodology are robust against a range of modelling assumptions, including adjusting for competing risks. Copyright © 2011 John Wiley & Sons, Ltd. PMID:21905066

A guideline for adults with an indwelling urinary catheter in different health care Settings - methodological procedures

PubMed

Barbezat, Isabelle; Willener, Rita; Jenni, Giovanna; Hürlimann, Barbara; Geese, Franziska; Spichiger, Elisabeth

2017-07-01

Background: People with an indwelling urinary catheter often suffer from complications and health care professionals are regularly confronted with questions about catheter management. Clinical guidelines are widely accepted to promote evidence-based practice. In the literature, the adaptation of a guideline is described as a valid alternative to the development of a new one. Aim: To translate a guideline for the care for adults with an indwelling urinary catheter in the acute and long term care setting as well as for home care. To adapt the guideline to the Swiss context. Method: In a systematic and pragmatic process, clinical questions were identified, guidelines were searched and evaluated regarding clinical relevance and quality. After each step, the next steps were defined. Results: An English guideline was translated, adapted to the local context and supplemented. The adapted guideline was reviewed by experts, adapted again and approved. After 34 months and an investment of a total of 145 man working days, a guideline for the care for people with an indwelling urinary catheter is available for both institutions. Conclusions: Translation and adaptation of a guideline was a valuable alternative to the development of a new one; nevertheless, the efforts necessary should not be underestimated. For such a project, sufficient professional and methodological resources should be made available to achieve efficient guideline work by a constant team.

Critical appraisal of clinical trials in multiple system atrophy: Toward better quality.

PubMed

Castro Caldas, Ana; Levin, Johannes; Djaldetti, Ruth; Rascol, Olivier; Wenning, Gregor; Ferreira, Joaquim J

2017-10-01

Multiple system atrophy (MSA) is a rare neurodegenerative disease of undetermined cause. Although many clinical trials have been conducted, there is still no treatment that cures the disease or slows its progression. We sought to assess the clinical trials, methodology, and quality of reporting of clinical trails conducted in MSA patients. We conducted a systematic review of all trials with at least 1 MSA patient subject to any pharmacological/nonpharmacological interventions. Two independent reviewers evaluated the methodological characteristics and quality of reporting of trials. A total of 60 clinical trials were identified, including 1375 MSA patients. Of the trials, 51% (n = 31) were single-arm studies. A total of 28% (n = 17) had a parallel design, half of which (n = 13) were placebo controlled. Of the studies, 8 (13.3%) were conducted in a multicenter setting, 3 of which were responsible for 49.3% (n = 678) of the total included MSA patients. The description of primary outcomes was unclear in 60% (n = 40) of trials. Only 10 (16.7%) clinical trials clearly described the randomization process. Blinding of the participants, personnel, and outcome assessments were at high risk of bias in the majority of studies. The number of dropouts/withdrawals was high (n = 326, 23.4% among the included patients). Overall, the design and quality of reporting of the reviewed studies is unsatisfactory. The most frequent clinical trials were small and single centered. Inadequate reporting was related to the information on the randomization process, sequence generation, allocation concealment, blinding of participants, and sample size calculations. Although improved during the recent years, methodological quality and trial design need to be optimized to generate more informative results. © 2017 International Parkinson and Movement Disorder Society. © 2017 International Parkinson and Movement Disorder Society.

Clinical trials in crisis: four simple methodologic fixes

PubMed Central

Vickers, Andrew J.

2014-01-01

There is growing consensus that the US clinical trials system is broken, with trial costs and complexity increasing exponentially, and many trials failing to accrue. Yet concerns about the expense and failure rate of randomized trials are only the tip of the iceberg; perhaps what should worry us most is the number of trials that are not even considered because of projected costs and poor accrual. Several initiatives, including the Clinical Trials Transformation Initiative and the “Sensible Guidelines Group” seek to push back against current trends in clinical trials, arguing that all aspects of trials - including design, approval, conduct, monitoring, analysis and dissemination - should be based on evidence rather than contemporary norms. Proposed here are four methodologic fixes for current clinical trials. The first two aim to simplify trials, reducing costs and increasing patient acceptability by dramatically reducing eligibility criteria - often to the single criterion that the consenting physician is uncertain which of the two randomized arms is optimal - and by clinical integration, investment in data infrastructure to bring routinely collected data up to research grade to be used as endpoints in trials. The second two methodologic fixes aim to shed barriers to accrual, either by cluster randomization of clinicians (in the case of modifications to existing treatment) or by early consent, where patients are offered the chance of being randomly selected to be offered a novel intervention if disease progresses at a subsequent point. Such solutions may be partial, or result in a new set of problems of their own. Yet the current crisis in clinical trials mandates innovative approaches: randomized trials have resulted in enormous benefits for patients and we need to ensure that they continue to do so. PMID:25278228

Clinical trials in crisis: Four simple methodologic fixes.

PubMed

Vickers, Andrew J

2014-12-01

There is growing consensus that the US clinical trials system is broken, with trial costs and complexity increasing exponentially, and many trials failing to accrue. Yet, concerns about the expense and failure rate of randomized trials are only the tip of the iceberg; perhaps what should worry us most is the number of trials that are not even considered because of projected costs and poor accrual. Several initiatives, including the Clinical Trials Transformation Initiative and the "Sensible Guidelines Group" seek to push back against current trends in clinical trials, arguing that all aspects of trials-including design, approval, conduct, monitoring, analysis, and dissemination-should be based on evidence rather than contemporary norms. Proposed here are four methodologic fixes for current clinical trials. The first two aim to simplify trials, reducing costs, and increasing patient acceptability by dramatically reducing eligibility criteria-often to the single criterion that the consenting physician is uncertain which of the two randomized arms is optimal-and by clinical integration, investment in data infrastructure to bring routinely collected data up to research grade to be used as endpoints in trials. The second two methodologic fixes aim to shed barriers to accrual, either by cluster randomization of clinicians (in the case of modifications to existing treatment) or by early consent, where patients are offered the chance of being randomly selected to be offered a novel intervention if disease progresses at a subsequent point. Such solutions may be partial, or result in a new set of problems of their own. Yet, the current crisis in clinical trials mandates innovative approaches: randomized trials have resulted in enormous benefits for patients, and we need to ensure that they continue to do so. © The Author(s) 2014.

Emerging Concepts and Methodologies in Cancer Biomarker Discovery.

PubMed

Lu, Meixia; Zhang, Jinxiang; Zhang, Lanjing

2017-01-01

Cancer biomarker discovery is a critical part of cancer prevention and treatment. Despite the decades of effort, only a small number of cancer biomarkers have been identified for and validated in clinical settings. Conceptual and methodological breakthroughs may help accelerate the discovery of additional cancer biomarkers, particularly their use for diagnostics. In this review, we have attempted to review the emerging concepts in cancer biomarker discovery, including real-world evidence, open access data, and data paucity in rare or uncommon cancers. We have also summarized the recent methodological progress in cancer biomarker discovery, such as high-throughput sequencing, liquid biopsy, big data, artificial intelligence (AI), and deep learning and neural networks. Much attention has been given to the methodological details and comparison of the methodologies. Notably, these concepts and methodologies interact with each other and will likely lead to synergistic effects when carefully combined. Newer, more innovative concepts and methodologies are emerging as the current emerging ones became mainstream and widely applied to the field. Some future challenges are also discussed. This review contributes to the development of future theoretical frameworks and technologies in cancer biomarker discovery and will contribute to the discovery of more useful cancer biomarkers.

GSK's antigen-specific cancer immunotherapy programme: pilot results leading to Phase III clinical development.

PubMed

Brichard, Vincent G; Lejeune, Diane

2007-09-27

From the first evidence that the immune system could recognize tumors, different types of tumor antigens have been identified and deeply characterized. Several different approaches aimed at targeting these antigens have already been the subject of clinical studies. In this field, the GSK Biologicals' approach relying on recombinant proteins combined with an immunological Adjuvant System in a specific clinical setting, has entertained hopes of developing a new class of well tolerated anti-cancer therapy. This methodology led to promising advances with MAGE-A3 immunotherapy in NSCLC and has the potential to be applied to all tumor types.

The Human Microbiome and Understanding the 16S rRNA Gene in Translational Nursing Science.

PubMed

Ames, Nancy J; Ranucci, Alexandra; Moriyama, Brad; Wallen, Gwenyth R

As more is understood regarding the human microbiome, it is increasingly important for nurse scientists and healthcare practitioners to analyze these microbial communities and their role in health and disease. 16S rRNA sequencing is a key methodology in identifying these bacterial populations that has recently transitioned from use primarily in research to having increased utility in clinical settings. The objectives of this review are to (a) describe 16S rRNA sequencing and its role in answering research questions important to nursing science; (b) provide an overview of the oral, lung, and gut microbiomes and relevant research; and (c) identify future implications for microbiome research and 16S sequencing in translational nursing science. Sequencing using the 16S rRNA gene has revolutionized research and allowed scientists to easily and reliably characterize complex bacterial communities. This type of research has recently entered the clinical setting, one of the best examples involving the use of 16S sequencing to identify resistant pathogens, thereby improving the accuracy of bacterial identification in infection control. Clinical microbiota research and related requisite methods are of particular relevance to nurse scientists-individuals uniquely positioned to utilize these techniques in future studies in clinical settings.

Modeling-Enabled Systems Nutritional Immunology

PubMed Central

Verma, Meghna; Hontecillas, Raquel; Abedi, Vida; Leber, Andrew; Tubau-Juni, Nuria; Philipson, Casandra; Carbo, Adria; Bassaganya-Riera, Josep

2016-01-01

This review highlights the fundamental role of nutrition in the maintenance of health, the immune response, and disease prevention. Emerging global mechanistic insights in the field of nutritional immunology cannot be gained through reductionist methods alone or by analyzing a single nutrient at a time. We propose to investigate nutritional immunology as a massively interacting system of interconnected multistage and multiscale networks that encompass hidden mechanisms by which nutrition, microbiome, metabolism, genetic predisposition, and the immune system interact to delineate health and disease. The review sets an unconventional path to apply complex science methodologies to nutritional immunology research, discovery, and development through “use cases” centered around the impact of nutrition on the gut microbiome and immune responses. Our systems nutritional immunology analyses, which include modeling and informatics methodologies in combination with pre-clinical and clinical studies, have the potential to discover emerging systems-wide properties at the interface of the immune system, nutrition, microbiome, and metabolism. PMID:26909350

Challenges in evaluating cancer as a clinical outcome in postapproval studies of drug safety

PubMed Central

Pinheiro, Simone P.; Rivera, Donna R.; Graham, David J.; Freedman, Andrew N.; Major, Jacqueline M.; Penberthy, Lynne; Levenson, Mark; Bradley, Marie C.; Wong, Hui-Lee; Ouellet-Hellstrom, Rita

2017-01-01

Pharmaceuticals approved in the United States are largely not known human carcinogens. However, cancer signals associated with pharmaceuticals may be hypothesized or arise after product approval. There are many study designs that can be used to evaluate cancer as an outcome in the postapproval setting. Because prospective systematic collection of cancer outcomes from a large number of individuals may be lengthy, expensive, and challenging, leveraging data from large existing databases are an integral approach. Such studies have the capability to evaluate the clinical experience of a large number of individuals, yet there are unique methodological challenges involved in their use to evaluate cancer outcomes. To discuss methodological challenges and potential solutions, the Food and Drug Administration and the National Cancer Institute convened a two-day public meeting in 2014. This commentary summarizes the most salient issues discussed at the meeting. PMID:27663208

Challenges in evaluating cancer as a clinical outcome in postapproval studies of drug safety.

PubMed

Pinheiro, Simone P; Rivera, Donna R; Graham, David J; Freedman, Andrew N; Major, Jacqueline M; Penberthy, Lynne; Levenson, Mark; Bradley, Marie C; Wong, Hui-Lee; Ouellet-Hellstrom, Rita

2016-11-01

Pharmaceuticals approved in the United States are largely not known human carcinogens. However, cancer signals associated with pharmaceuticals may be hypothesized or arise after product approval. There are many study designs that can be used to evaluate cancer as an outcome in the postapproval setting. Because prospective systematic collection of cancer outcomes from a large number of individuals may be lengthy, expensive, and challenging, leveraging data from large existing databases are an integral approach. Such studies have the capability to evaluate the clinical experience of a large number of individuals, yet there are unique methodological challenges involved in their use to evaluate cancer outcomes. To discuss methodological challenges and potential solutions, the Food and Drug Administration and the National Cancer Institute convened a two-day public meeting in 2014. This commentary summarizes the most salient issues discussed at the meeting. Published by Elsevier Inc.

A methodology to ensure and improve accuracy of Ki67 labelling index estimation by automated digital image analysis in breast cancer tissue.

PubMed

Laurinavicius, Arvydas; Plancoulaine, Benoit; Laurinaviciene, Aida; Herlin, Paulette; Meskauskas, Raimundas; Baltrusaityte, Indra; Besusparis, Justinas; Dasevicius, Darius; Elie, Nicolas; Iqbal, Yasir; Bor, Catherine

2014-01-01

Immunohistochemical Ki67 labelling index (Ki67 LI) reflects proliferative activity and is a potential prognostic/predictive marker of breast cancer. However, its clinical utility is hindered by the lack of standardized measurement methodologies. Besides tissue heterogeneity aspects, the key element of methodology remains accurate estimation of Ki67-stained/counterstained tumour cell profiles. We aimed to develop a methodology to ensure and improve accuracy of the digital image analysis (DIA) approach. Tissue microarrays (one 1-mm spot per patient, n = 164) from invasive ductal breast carcinoma were stained for Ki67 and scanned. Criterion standard (Ki67-Count) was obtained by counting positive and negative tumour cell profiles using a stereology grid overlaid on a spot image. DIA was performed with Aperio Genie/Nuclear algorithms. A bias was estimated by ANOVA, correlation and regression analyses. Calibration steps of the DIA by adjusting the algorithm settings were performed: first, by subjective DIA quality assessment (DIA-1), and second, to compensate the bias established (DIA-2). Visual estimate (Ki67-VE) on the same images was performed by five pathologists independently. ANOVA revealed significant underestimation bias (P < 0.05) for DIA-0, DIA-1 and two pathologists' VE, while DIA-2, VE-median and three other VEs were within the same range. Regression analyses revealed best accuracy for the DIA-2 (R-square = 0.90) exceeding that of VE-median, individual VEs and other DIA settings. Bidirectional bias for the DIA-2 with overestimation at low, and underestimation at high ends of the scale was detected. Measurement error correction by inverse regression was applied to improve DIA-2-based prediction of the Ki67-Count, in particularfor the clinically relevant interval of Ki67-Count < 40%. Potential clinical impact of the prediction was tested by dichotomising the cases at the cut-off values of 10, 15, and 20%. Misclassification rate of 5-7% was achieved, compared to that of 11-18% for the VE-median-based prediction. Our experiments provide methodology to achieve accurate Ki67-LI estimation by DIA, based on proper validation, calibration, and measurement error correction procedures, guided by quantified bias from reference values obtained by stereology grid count. This basic validation step is an important prerequisite for high-throughput automated DIA applications to investigate tissue heterogeneity and clinical utility aspects of Ki67 and other immunohistochemistry (IHC) biomarkers.

A methodology to ensure and improve accuracy of Ki67 labelling index estimation by automated digital image analysis in breast cancer tissue

PubMed Central

2014-01-01

Introduction Immunohistochemical Ki67 labelling index (Ki67 LI) reflects proliferative activity and is a potential prognostic/predictive marker of breast cancer. However, its clinical utility is hindered by the lack of standardized measurement methodologies. Besides tissue heterogeneity aspects, the key element of methodology remains accurate estimation of Ki67-stained/counterstained tumour cell profiles. We aimed to develop a methodology to ensure and improve accuracy of the digital image analysis (DIA) approach. Methods Tissue microarrays (one 1-mm spot per patient, n = 164) from invasive ductal breast carcinoma were stained for Ki67 and scanned. Criterion standard (Ki67-Count) was obtained by counting positive and negative tumour cell profiles using a stereology grid overlaid on a spot image. DIA was performed with Aperio Genie/Nuclear algorithms. A bias was estimated by ANOVA, correlation and regression analyses. Calibration steps of the DIA by adjusting the algorithm settings were performed: first, by subjective DIA quality assessment (DIA-1), and second, to compensate the bias established (DIA-2). Visual estimate (Ki67-VE) on the same images was performed by five pathologists independently. Results ANOVA revealed significant underestimation bias (P < 0.05) for DIA-0, DIA-1 and two pathologists’ VE, while DIA-2, VE-median and three other VEs were within the same range. Regression analyses revealed best accuracy for the DIA-2 (R-square = 0.90) exceeding that of VE-median, individual VEs and other DIA settings. Bidirectional bias for the DIA-2 with overestimation at low, and underestimation at high ends of the scale was detected. Measurement error correction by inverse regression was applied to improve DIA-2-based prediction of the Ki67-Count, in particular for the clinically relevant interval of Ki67-Count < 40%. Potential clinical impact of the prediction was tested by dichotomising the cases at the cut-off values of 10, 15, and 20%. Misclassification rate of 5-7% was achieved, compared to that of 11-18% for the VE-median-based prediction. Conclusions Our experiments provide methodology to achieve accurate Ki67-LI estimation by DIA, based on proper validation, calibration, and measurement error correction procedures, guided by quantified bias from reference values obtained by stereology grid count. This basic validation step is an important prerequisite for high-throughput automated DIA applications to investigate tissue heterogeneity and clinical utility aspects of Ki67 and other immunohistochemistry (IHC) biomarkers. PMID:24708745

Overdiagnosis across medical disciplines: a scoping review.

PubMed

Jenniskens, Kevin; de Groot, Joris A H; Reitsma, Johannes B; Moons, Karel G M; Hooft, Lotty; Naaktgeboren, Christiana A

2017-12-27

To provide insight into how and in what clinical fields overdiagnosis is studied and give directions for further applied and methodological research. Scoping review. Medline up to August 2017. All English studies on humans, in which overdiagnosis was discussed as a dominant theme. Studies were assessed on clinical field, study aim (ie, methodological or non-methodological), article type (eg, primary study, review), the type and role of diagnostic test(s) studied and the context in which these studies discussed overdiagnosis. From 4896 studies, 1851 were included for analysis. Half of all studies on overdiagnosis were performed in the field of oncology (50%). Other prevalent clinical fields included mental disorders, infectious diseases and cardiovascular diseases accounting for 9%, 8% and 6% of studies, respectively. Overdiagnosis was addressed from a methodological perspective in 20% of studies. Primary studies were the most common article type (58%). The type of diagnostic tests most commonly studied were imaging tests (32%), although these were predominantly seen in oncology and cardiovascular disease (84%). Diagnostic tests were studied in a screening setting in 43% of all studies, but as high as 75% of all oncological studies. The context in which studies addressed overdiagnosis related most frequently to its estimation, accounting for 53%. Methodology on overdiagnosis estimation and definition provided a source for extensive discussion. Other contexts of discussion included definition of disease, overdiagnosis communication, trends in increasing disease prevalence, drivers and consequences of overdiagnosis, incidental findings and genomics. Overdiagnosis is discussed across virtually all clinical fields and in different contexts. The variability in characteristics between studies and lack of consensus on overdiagnosis definition indicate the need for a uniform typology to improve coherence and comparability of studies on overdiagnosis. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Global health trials methodological research agenda: results from a priority setting exercise.

PubMed

Rosala-Hallas, Anna; Bhangu, Aneel; Blazeby, Jane; Bowman, Louise; Clarke, Mike; Lang, Trudie; Nasser, Mona; Siegfried, Nandi; Soares-Weiser, Karla; Sydes, Matt R; Wang, Duolao; Zhang, Junhua; Williamson, Paula R

2018-02-05

Methodological research into the design, conduct, analysis and reporting of trials is essential to optimise the process. UK specialists in the field have established a set of top priorities in aid of this research. These priorities, however, may not be reflected in the needs of similar research in low- to middle-income countries (LMICs) with different healthcare provision, resources and research infrastructure. The aim of the study was to identify the top priorities for methodological research in LMICs to inform further research and ultimately to improve clinical trials in these regions. An online, two-round survey was conducted from December 2016 to April 2017 amongst researchers and methodologists working on trials in LMICs. The first round required participants to suggest between three and six topics which they felt were priorities for trial methodological research in LMICs. The second round invited participants to grade the importance of a compulsory list of topics suggested by four or more individuals, and an optional list of the remaining topics. Rounds 1 and 2 were completed by 412 and 314 participants, respectively. A wide spread of years of experience, discipline, current country of residence, origin of trials training and area of involvement in trials was reported. The topics deemed most important for methodological research were: choosing appropriate outcomes to measure and training of research staff. By presenting these top priorities we have the foundations of a global health trials methodological research agenda which we hope will foster future research in specific areas in order to increase and improve trials in LMICs.

Utility of the Roussel Uclaf Causality Assessment Method (RUCAM) to analyze the hepatic findings in a clinical trial program: evaluation of the direct thrombin inhibitor ximelagatran.

PubMed

Lewis, J H; Larrey, D; Olsson, R; Lee, W M; Frison, L; Keisu, M

2008-07-01

Causality assessment in drug-induced liver injury is often based on circumstantial evidence rather than a formal, systematic review. The Roussel Uclaf Causality Assessment Method (RUCAM) provides a more objective means of assessing causality of a suspected hepatotoxin but, to our knowledge, has never been used in the assessment of a single drug with unknown hepatotoxic potential in a clinical trial setting. We studied the utility of RUCAM in assessing the hepatic events during the long-term clinical trials of the oral direct thrombin inhibitor ximelagatran, which has been associated with an increased incidence of alanine aminotransferase (ALT) elevations. A total of 233 subjects with elevated ALT values signalling possibly severe hepatic injury were eligible for RUCAM analysis (198 ximelagatran and 35 comparator anticoagulants). RUCAM scores, calculated independently by the assessors, using the existing numerical criteria provided in its methodology, suggested a possible or probable causal relationship between ALT and ximelagatran in 37 and 27% of cases, respectively. Causality was excluded or unlikely in the remaining 36% of cases. However, in the course of utilizing RUCAM, several limitations to the methodology came to light, including awarding additional points for age > 55 years, an unspecified use of alcohol, and a latency period of < 90 days, which may have had the unintentional effect of raising the overall score. Moreover, rechallenge is highly rewarded by RUCAM but is seldom done in clinical practice or in clinical trials. We also found ambiguities in the extent to which other causes of liver injury were excluded, what constitutes a significant hepatotoxic concomitant medication, and whether a clinical trial drug should be considered as having an unknown hepatotoxic potential for purposes of RUCAM scoring. Increasing familiarity with the RUCAM over the course of the study allowed for only a slight improvement in concordance between and among the assessors regarding the scoring. While the results indicate that RUCAM can provide for an objective assessment of causality of the hepatotoxicity of a drug under development in the clinical trial setting, this study highlights a number of problems with the current scoring system that should be addressed by future enhancements of the methodology.

Priority setting in guideline development: article 2 in Integrating and coordinating efforts in COPD guideline development. An official ATS/ERS workshop report.

PubMed

Atkins, David; Perez-Padilla, Rogelio; Macnee, William; Buist, A Sonia; Cruz, Alvaro A

2012-12-01

Professional societies, like many other organizations around the world, have recognized the need to use more rigorous processes to ensure that health care recommendations are informed by the best available research evidence. Priority setting is an essential component of developing clinical practice guidelines informed by the best available research evidence. It ensures that resources and attention are devoted to those areas in which clinical recommendations will provide the greatest benefit to patients, clinicians, and policy makers. This is the second of a series of 14 articles that methodologists and researchers from around the world prepared to advise guideline developers in respiratory and other diseases. This review focuses on priority setting, addressing five key questions. In this review, we addressed the following questions. (1) At which steps of guideline development should priorities be considered? (2) How do we create an initial list of potential topics within the guideline? (3) What criteria should be used to establish priorities? (4) What parties should be involved and what processes should be used to set priorities? (5)What are the potential challenges of setting priorities? We updated an existing review on priority setting, and searched PubMed and other databases of methodological studies for existing systematic reviews and relevant methodological research. We did not conduct systematic reviews ourselves. Our conclusions are based on available evidence, our own experience working with guideline developers, and workshop discussions. Existing literature on priority setting largely applies to identifying priorities for which guidelines to develop rather than setting priorities for recommendations within a guideline. Nonetheless, there is substantial consensus about the general factors that should be considered in setting priorities. These include the burdens and costs of illness, potential impact of a recommendation, identified deficits or weak points in practice, variation or uncertainty in practice, and availability of evidence. The input of a variety of stakeholders is useful in setting priorities, although informal consultation is used more often than formal methods. Processes for setting priorities remains poorly described in most guidelines.

Evaluating online diagnostic decision support tools for the clinical setting.

PubMed

Pryor, Marie; White, David; Potter, Bronwyn; Traill, Roger

2012-01-01

Clinical decision support tools available at the point of care are an effective adjunct to support clinicians to make clinical decisions and improve patient outcomes. We developed a methodology and applied it to evaluate commercially available online clinical diagnostic decision support (DDS) tools for use at the point of care. We identified 11 commercially available DDS tools and assessed these against an evaluation instrument that included 6 categories; general information, content, quality control, search, clinical results and other features. We developed diagnostically challenging clinical case scenarios based on real patient experience that were commonly missed by junior medical staff. The evaluation was divided into 2 phases; an initial evaluation of all identified and accessible DDS tools conducted by the Clinical Information Access Portal (CIAP) team and a second phase that further assessed the top 3 tools identified in the initial evaluation phase. An evaluation panel consisting of senior and junior medical clinicians from NSW Health conducted the second phase. Of the eleven tools that were assessed against the evaluation instrument only 4 tools completely met the DDS definition that was adopted for this evaluation and were able to produce a differential diagnosis. From the initial phase of the evaluation 4 DDS tools scored 70% or more (maximum score 96%) for the content category, 8 tools scored 65% or more (maximum 100%) for the quality control category, 5 tools scored 65% or more (maximum 94%) for the search category, and 4 tools score 70% or more (maximum 81%) for the clinical results category. The second phase of the evaluation was focused on assessing diagnostic accuracy for the top 3 tools identified in the initial phase. Best Practice ranked highest overall against the 6 clinical case scenarios used. Overall the differentiating factor between the top 3 DDS tools was determined by diagnostic accuracy ranking, ease of use and the confidence and credibility of the clinical information. The evaluation methodology used here to assess the quality and comprehensiveness of clinical DDS tools was effective in identifying the most appropriate tool for the clinical setting. The use of clinical case scenarios is fundamental in determining the diagnostic accuracy and usability of the tools.

A Design Methodology for Medical Processes.

PubMed

Ferrante, Simona; Bonacina, Stefano; Pozzi, Giuseppe; Pinciroli, Francesco; Marceglia, Sara

2016-01-01

Healthcare processes, especially those belonging to the clinical domain, are acknowledged as complex and characterized by the dynamic nature of the diagnosis, the variability of the decisions made by experts driven by their experiences, the local constraints, the patient's needs, the uncertainty of the patient's response, and the indeterminacy of patient's compliance to treatment. Also, the multiple actors involved in patient's care need clear and transparent communication to ensure care coordination. In this paper, we propose a methodology to model healthcare processes in order to break out complexity and provide transparency. The model is grounded on a set of requirements that make the healthcare domain unique with respect to other knowledge domains. The modeling methodology is based on three main phases: the study of the environmental context, the conceptual modeling, and the logical modeling. The proposed methodology was validated by applying it to the case study of the rehabilitation process of stroke patients in the specific setting of a specialized rehabilitation center. The resulting model was used to define the specifications of a software artifact for the digital administration and collection of assessment tests that was also implemented. Despite being only an example, our case study showed the ability of process modeling to answer the actual needs in healthcare practices. Independently from the medical domain in which the modeling effort is done, the proposed methodology is useful to create high-quality models, and to detect and take into account relevant and tricky situations that can occur during process execution.

Back schools for non-specific low-back pain.

PubMed

Heymans, M W; van Tulder, M W; Esmail, R; Bombardier, C; Koes, B W

2004-10-18

Since the introduction of the Swedish back school in 1969, back schools have frequently been used for treating patients with low-back pain (LBP). However, the content of back schools has changed and appears to vary widely today. To assess the effectiveness of back schools for patients with non-specific LBP. We searched the MEDLINE and EMBASE databases and the Cochrane Central Register of Controlled Trials to May 2003 for relevant trials reported in English, Dutch, French or German. We also screened references from relevant reviews and included trials. Randomized controlled trials (RCTs) that reported on any type of back school for non-specific LBP were included. Four reviewers, blinded to authors, institution and journal, independently extracted the data and assessed the quality of the trials. We set the high quality level, a priori, at a trial meeting six or more of 11 internal validity criteria. As data were clinically and statistically too heterogeneous to perform a meta-analysis, we used a qualitative review (best evidence synthesis) to summarize the results. The evidence was classified into four levels (strong, moderate, limited or no evidence), taking into account the methodological quality of the studies. We also evaluated the clinical relevance of the studies. Nineteen RCTs (3584 patients) were included in this updated review. Overall, the methodological quality was low, with only six trials considered to be high quality. It was not possible to perform relevant subgroup analyses for LBP with radiation versus LBP without radiation. The results indicate that there is moderate evidence suggesting that back schools have better short and intermediate-term effects on pain and functional status than other treatments for patients with recurrent and chronic LBP. There is moderate evidence suggesting that back schools for chronic LBP in an occupational setting, are more effective than other treatments and placebo or waiting list controls on pain, functional status and return to work during short and intermediate-term follow-up. In general, the clinical relevance of the studies was rated as insufficient. There is moderate evidence suggesting that back schools, in an occupational setting, reduce pain, and improve function and return-to-work status, in the short and intermediate-term, compared to exercises, manipulation, myofascial therapy, advice, placebo or waiting list controls, for patients with chronic and recurrent LBP. However, future trials should improve methodological quality and clinical relevance and evaluate the cost-effectiveness of back schools.

Representation of Biomedical Expertise in Ontologies: a Case Study about Knowledge Acquisition on HTLV viruses and their clinical manifestations.

PubMed

Cardoso Coelho, Kátia; Barcellos Almeida, Maurício

2015-01-01

In this paper, we introduce a set of methodological steps for knowledge acquisition applied to the organization of biomedical information through ontologies. Those steps are tested in a real case involving Human T Cell Lymphotropic Virus (HTLV), which causes myriad infectious diseases. We hope to contribute to providing suitable knowledge representation of scientific domains.

An ``Openable,'' High-Strength Gradient Set for Orthopedic MRI

NASA Astrophysics Data System (ADS)

Crozier, Stuart; Roffmann, Wolfgang U.; Luescher, Kurt; Snape-Jenkinson, Christopher; Forbes, Lawrence K.; Doddrell, David M.

1999-07-01

A novel three-axis gradient set and RF resonator for orthopedic MRI has been designed and constructed. The set is openable and may be wrapped around injured joints. The design methodology used was the minimization of magnetic field spherical harmonics by simulated annealing. Splitting of the longitudinal coil presents the major design challenge to a fully openable gradient set and in order to efficiently design such coils, we have developed a new fast algorithm for determining the magnetic field spherical harmonics generated by an arc of multiturn wire. The algorithm allows a realistic impression of the effect of split longitudinal designs. A prototype set was constructed based on the new designs and tested in a 2-T clinical research system. The set generated 12 mT/m/A with a linear region of 12 cm and a switching time of 100 μs, conforming closely with theoretical predictions. Preliminary images from the set are presented.

New scoring methodology improves the sensitivity of the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) in clinical trials.

PubMed

Verma, Nishant; Beretvas, S Natasha; Pascual, Belen; Masdeu, Joseph C; Markey, Mia K

2015-11-12

As currently used, the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) has low sensitivity for measuring Alzheimer's disease progression in clinical trials. A major reason behind the low sensitivity is its sub-optimal scoring methodology, which can be improved to obtain better sensitivity. Using item response theory, we developed a new scoring methodology (ADAS-CogIRT) for the ADAS-Cog, which addresses several major limitations of the current scoring methodology. The sensitivity of the ADAS-CogIRT methodology was evaluated using clinical trial simulations as well as a negative clinical trial, which had shown an evidence of a treatment effect. The ADAS-Cog was found to measure impairment in three cognitive domains of memory, language, and praxis. The ADAS-CogIRT methodology required significantly fewer patients and shorter trial durations as compared to the current scoring methodology when both were evaluated in simulated clinical trials. When validated on data from a real clinical trial, the ADAS-CogIRT methodology had higher sensitivity than the current scoring methodology in detecting the treatment effect. The proposed scoring methodology significantly improves the sensitivity of the ADAS-Cog in measuring progression of cognitive impairment in clinical trials focused in the mild-to-moderate Alzheimer's disease stage. This provides a boost to the efficiency of clinical trials requiring fewer patients and shorter durations for investigating disease-modifying treatments.

Speech-language pathology in the long-term care setting: it isn't your grandmother's nursing home anymore.

PubMed

Casper, Mary L

2013-04-01

This article considers the career of speech-language pathologists practicing in long-term care/skilled nursing facility settings. The range of conditions that lead to communication, cognition, and/or swallowing disorders that are evaluated and treated by the speech-language pathologist in the long-term care setting are examined. Various methodologies for reimbursement are discussed, including the Medicare Physicians' Fee Schedule associated with Medicare Part B and the Prospective Payment System associated with Medicare Part A. Suggestions for effective clinical service delivery are reviewed, along with best practices for interdisciplinary team communication. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Engaging hard to engage clients: a Q methodological study involving clinical psychologists.

PubMed

Lister, Matthew; Gardner, Damian

2006-09-01

This research uses Q methodology to collate a number of techniques, and to investigate what techniques are used to encourage engagement across a number of clinical psychology specialities. Eleven groups of participants from different clinical specialities were interviewed in order to develop a set of 51 statements reflecting engagement techniques that clinicians felt that they were likely to use with 'hard to engage' clients. Seventy-five participants from a similar range of specialities were then asked to Q sort these statements and provide other demographic information. Forty-four participants returned completed Q sorts which were factor analysed by a tailored program (PQ Method) to investigate how the statements fall into patterns that reflect ways clinicians approach engagement. Varimax rotation produced five factors, four of which were able to be interpreted by participant information and comments. These accounts were taken back to some of the initial participants for 'reflexive correction' (Stainton Rogers, 1995). The four factor patterns are discussed in relation to existing literature and the research questions. These identified factors are: (i) the client focused approach; (ii) the interpersonal professional; (iii) the 'eclectic' or systemic approach; (iv) the expert listener. The implications for training, clinical practice and research are discussed.

Towards application of rule learning to the meta-analysis of clinical data: an example of the metabolic syndrome.

PubMed

Wojtusiak, Janusz; Michalski, Ryszard S; Simanivanh, Thipkesone; Baranova, Ancha V

2009-12-01

Systematic reviews and meta-analysis of published clinical datasets are important part of medical research. By combining results of multiple studies, meta-analysis is able to increase confidence in its conclusions, validate particular study results, and sometimes lead to new findings. Extensive theory has been built on how to aggregate results from multiple studies and arrive to the statistically valid conclusions. Surprisingly, very little has been done to adopt advanced machine learning methods to support meta-analysis. In this paper we describe a novel machine learning methodology that is capable of inducing accurate and easy to understand attributional rules from aggregated data. Thus, the methodology can be used to support traditional meta-analysis in systematic reviews. Most machine learning applications give primary attention to predictive accuracy of the learned knowledge, and lesser attention to its understandability. Here we employed attributional rules, the special form of rules that are relatively easy to interpret for medical experts who are not necessarily trained in statistics and meta-analysis. The methodology has been implemented and initially tested on a set of publicly available clinical data describing patients with metabolic syndrome (MS). The objective of this application was to determine rules describing combinations of clinical parameters used for metabolic syndrome diagnosis, and to develop rules for predicting whether particular patients are likely to develop secondary complications of MS. The aggregated clinical data was retrieved from 20 separate hospital cohorts that included 12 groups of patients with present liver disease symptoms and 8 control groups of healthy subjects. The total of 152 attributes were used, most of which were measured, however, in different studies. Twenty most common attributes were selected for the rule learning process. By applying the developed rule learning methodology we arrived at several different possible rulesets that can be used to predict three considered complications of MS, namely nonalcoholic fatty liver disease (NAFLD), simple steatosis (SS), and nonalcoholic steatohepatitis (NASH).

[Evaluation of a teaching ambulatory module of respiratory diseases in the undergraduate medical curriculum].

PubMed

Leiva R, Isabel; Bitran C, Marcela; Saldías P, Fernando

2012-05-01

As the focus of healthcare provision shifts towards ambulatory care, increasing attention must now be given to develop opportunities for clinical teaching in this setting. To assess teacher and students' views about the strengths and weaknesses of real and simulated patient interactions for teaching undergraduate students clinical skills in the ambulatory setting. Fourth-year medical students were exposed in a systematic way, during two weeks, to real and simulated patients in an outpatient clinic, who presented common respiratory problems, such as asthma, chronic obstructive pulmonary disease, smoking and sleep apnea syndrome. After the clinical interview, students received feedback from the tutor and their peers. The module was assessed interviewing the teachers and evaluating the results qualitatively. Students evaluated the contents and quality of teaching at the end of the rotation. Tutors identified the factors that facilitate ambulatory teaching. These depended on the module design, resources and patient care, of characteristics of students and their participation, leadership and interaction with professors. They also identified factors that hamper teaching activities such as availability of resources, student motivation and academic recognition. Most students evaluated favorably the interaction with real and simulated patients in the ambulatory setting. Teaching in the ambulatory setting was well evaluated by students and teachers. The use of qualitative methodology allowed contrasting the opinions of teachers and students.

New statistical learning theory paradigms adapted to breast cancer diagnosis/classification using image and non-image clinical data.

PubMed

Land, Walker H; Heine, John J; Raway, Tom; Mizaku, Alda; Kovalchuk, Nataliya; Yang, Jack Y; Yang, Mary Qu

2008-01-01

The automated decision paradigms presented in this work address the false positive (FP) biopsy occurrence in diagnostic mammography. An EP/ES stochastic hybrid and two kernelized Partial Least Squares (K-PLS) paradigms were investigated with following studies: methodology performance comparisonsautomated diagnostic accuracy assessments with two data sets. The findings showed: the new hybrid produced comparable results more rapidlythe new K-PLS paradigms train and operate Essentially in real time for the data sets studied. Both advancements are essential components for eventually achieving the FP reduction goal, while maintaining acceptable diagnostic sensitivities.

New statistical learning theory paradigms adapted to breast cancer diagnosis/classification using image and non-image clinical data

PubMed Central

Raway, Tom; Mizaku, Alda; Kovalchuk, Nataliya; Yang, Jack Y.; Yang, Mary Qu

2015-01-01

The automated decision paradigms presented in this work address the false positive (FP) biopsy occurrence in diagnostic mammography. An EP/ES stochastic hybrid and two kernelized Partial Least Squares (K-PLS) paradigms were investigated with following studies: methodology performance comparisonsautomated diagnostic accuracy assessments with two data sets. The findings showed: the new hybrid produced comparable results more rapidlythe new K-PLS paradigms train and operate Essentially in real time for the data sets studied. Both advancements are essential components for eventually achieving the FP reduction goal, while maintaining acceptable diagnostic sensitivities. PMID:26430470

Experimental platform utilising melting curve technology for detection of mutations in Mycobacterium tuberculosis isolates.

PubMed

Broda, Agnieszka; Nikolayevskyy, Vlad; Casali, Nicki; Khan, Huma; Bowker, Richard; Blackwell, Gemma; Patel, Bhakti; Hume, James; Hussain, Waqar; Drobniewski, Francis

2018-04-20

Tuberculosis (TB) remains one of the most deadly infections with approximately a quarter of cases not being identified and/or treated mainly due to a lack of resources. Rapid detection of TB or drug-resistant TB enables timely adequate treatment and is a cornerstone of effective TB management. We evaluated the analytical performance of a single-tube assay for multidrug-resistant TB (MDR-TB) on an experimental platform utilising RT-PCR and melting curve analysis that could potentially be operated as a point-of-care (PoC) test in resource-constrained settings with a high burden of TB. Firstly, we developed and evaluated the prototype MDR-TB assay using specimens extracted from well-characterised TB isolates with a variety of distinct rifampicin and isoniazid resistance conferring mutations and nontuberculous Mycobacteria (NTM) strains. Secondly, we validated the experimental platform using 98 clinical sputum samples from pulmonary TB patients collected in high MDR-TB settings. The sensitivity of the platform for TB detection in clinical specimens was 75% for smear-negative and 92.6% for smear-positive sputum samples. The sensitivity of detection for rifampicin and isoniazid resistance was 88.9 and 96.0% and specificity was 87.5 and 100%, respectively. Observed limitations in sensitivity and specificity could be resolved by adjusting the sample preparation methodology and melting curve recognition algorithm. Overall technology could be considered a promising PoC methodology especially in resource-constrained settings based on its combined accuracy, convenience, simplicity, speed, and cost characteristics.

Creating peer groups for assessing and comparing nursing home performance.

PubMed

Byrne, Margaret M; Daw, Christina; Pietz, Ken; Reis, Brian; Petersen, Laura A

2013-11-01

Publicly reported performance data for hospitals and nursing homes are becoming ubiquitous. For such comparisons to be fair, facilities must be compared with their peers. To adapt a previously published methodology for developing hospital peer groupings so that it is applicable to nursing homes and to explore the characteristics of "nearest-neighbor" peer groupings. Analysis of Department of Veterans Affairs administrative databases and nursing home facility characteristics. The nearest-neighbor methodology for developing peer groupings involves calculating the Euclidean distance between facilities based on facility characteristics. We describe our steps in selection of facility characteristics, describe the characteristics of nearest-neighbor peer groups, and compare them with peer groups derived through classical cluster analysis. The facility characteristics most pertinent to nursing home groupings were found to be different from those that were most relevant for hospitals. Unlike classical cluster groups, nearest neighbor groups are not mutually exclusive, and the nearest-neighbor methodology resulted in nursing home peer groupings that were substantially less diffuse than nursing home peer groups created using traditional cluster analysis. It is essential that healthcare policy makers and administrators have a means of fairly grouping facilities for the purposes of quality, cost, or efficiency comparisons. In this research, we show that a previously published methodology can be successfully applied to a nursing home setting. The same approach could be applied in other clinical settings such as primary care.

Enhanced protocol for real-time transmission of echocardiograms over wireless channels.

PubMed

Cavero, Eva; Alesanco, Alvaro; García, Jose

2012-11-01

This paper presents a methodology to transmit clinical video over wireless networks in real-time. A 3-D set partitioning in hierarchical trees compression prior to transmission is proposed. In order to guarantee the clinical quality of the compressed video, a clinical evaluation specific to each video modality has to be made. This evaluation indicates the minimal transmission rate necessary for an accurate diagnosis. However, the channel conditions produce errors and distort the video. A reliable application protocol is therefore proposed using a hybrid solution in which either retransmission or retransmission combined with forward error correction (FEC) techniques are used, depending on the channel conditions. In order to analyze the proposed methodology, the 2-D mode of an echocardiogram has been assessed. A bandwidth of 200 kbps is necessary to guarantee its clinical quality. The transmission using the proposed solution and retransmission and FEC techniques working separately have been simulated and compared in high-speed uplink packet access (HSUPA) and worldwide interoperability for microwave access (WiMAX) networks. The proposed protocol achieves guaranteed clinical quality for bit error rates higher than with the other protocols, being for a mobile speed of 60 km/h up to 3.3 times higher for HSUPA and 10 times for WiMAX.

Urological cancer care pathways: development and use in the context of systematic reviews and clinical practice guidelines.

PubMed

Maclennan, Sara Jane; Maclennan, Steven J; Imamura, Mari; Omar, Muhammad Imran; Vale, Luke; Lam, Thomas; Royle, Pamela; Royle, Justine; Swami, Satchi; Pickard, Rob; McClinton, Sam; Griffiths, T R Leyshon; Dahm, Philipp; N'dow, James

2011-06-01

Making healthcare treatment decisions is a complex process involving a broad stakeholder base including patients, their families, health professionals, clinical practice guideline developers and funders of healthcare. This paper presents a review of a methodology for the development of urological cancer care pathways (UCAN care pathways), which reflects an appreciation of this broad stakeholder base. The methods section includes an overview of the steps in the development of the UCAN care pathways and engagement with clinical content experts and patient groups. The development process is outlined, the uses of the urological cancer care pathways discussed and the implications for clinical practice highlighted. The full set of UCAN care pathways is published in this paper. These include care pathways on localised prostate cancer, locally advanced prostate cancer, metastatic prostate cancer, hormone-resistant prostate cancer, localised renal cell cancer, advanced renal cell cancer, testicular cancer, penile cancer, muscle invasive and metastatic bladder cancer and non-muscle invasive bladder cancer. The process provides a useful framework for improving urological cancer care through evidence synthesis, research prioritisation, stakeholder involvement and international collaboration. Although the focus of this work is urological cancers, the methodology can be applied to all aspects of urology and is transferable to other clinical specialties.

Commentary: considerations for using the 'Trials within Cohorts' design in a clinical trial of an investigational medicinal product.

PubMed

Bibby, Anna C; Torgerson, David J; Leach, Samantha; Lewis-White, Helen; Maskell, Nick A

2018-01-08

The 'trials within cohorts' (TwiC) design is a pragmatic approach to randomised trials in which trial participants are randomly selected from an existing cohort. The design has multiple potential benefits, including the option of conducting multiple trials within the same cohort. To date, the TwiC design methodology been used in numerous clinical settings but has never been applied to a clinical trial of an investigational medicinal product (CTIMP). We have recently secured the necessary approvals to undertake the first CTIMP using the TwiC design. In this paper, we describe some of the considerations and modifications required to ensure such a trial is compliant with Good Clinical Practice and international clinical trials regulations. We advocate using a two-stage consent process and using the consent stages to explicitly differentiate between trial participants and cohort participants who are providing control data. This distinction ensured compliance but had consequences with respect to costings, recruitment and the trial assessment schedule. We have demonstrated that it is possible to secure ethical and regulatory approval for a CTIMP TwiC. By including certain considerations at the trial design stage, we believe this pragmatic and efficient methodology could be utilised in other CTIMPs in future.

A systematic review of patient tracking systems for use in the pediatric emergency department.

PubMed

Dobson, Ian; Doan, Quynh; Hung, Geoffrey

2013-01-01

Patient safety is of great importance in the pediatric emergency department (PED). The combination of acutely and critically ill patients and high patient volumes creates a need for systems to support physicians in making accurate and timely diagnoses. Electronic patient tracking systems can potentially improve PED safety by reducing overcrowding and enhancing security. To enhance our understanding of current electronic tracking technologies, how they are implemented in a clinical setting, and resulting effect on patient care outcomes including patient safety. Nine databases were searched. Two independent reviewers identified articles that contained reference to patient tracking technologies in pediatrics or emergency medicine. Quantitative studies were assessed independently for methodological strength by two reviewers using an external assessment tool. Of 2292 initial articles, 22 were deemed relevant. Seventeen were qualitative, and the remaining five quantitative articles were assessed as being methodologically weak. Existing patient tracking systems in the ED included: infant monitoring/abduction prevention; barcode identification; radiofrequency identification (RFID)- or infrared (IR)-based patient tracking. Twenty articles supported the use of tracking technology to enhance patient safety or improve efficiency. One article failed to support the use of IR patient sensors due to study design flaws. Support exists for the use of barcode-, IR-, and RFID-based patient tracking systems to improve ED patient safety and efficiency. A lack of methodologically strong studies indicates a need for further evidence-based support for the implementation of patient tracking technology in a clinical or research setting. Copyright © 2013 Elsevier Inc. All rights reserved.

The quality of the evidence base for clinical pathway effectiveness: room for improvement in the design of evaluation trials.

PubMed

Rotter, Thomas; Kinsman, Leigh; James, Erica; Machotta, Andreas; Steyerberg, Ewout W

2012-06-18

The purpose of this article is to report on the quality of the existing evidence base regarding the effectiveness of clinical pathway (CPW) research in the hospital setting. The analysis is based on a recently published Cochrane review of the effectiveness of CPWs. An integral component of the review process was a rigorous appraisal of the methodological quality of published CPW evaluations. This allowed the identification of strengths and limitations of the evidence base for CPW effectiveness. We followed the validated Cochrane Effective Practice and Organisation of Care Group (EPOC) criteria for randomized and non-randomized clinical pathway evaluations. In addition, we tested the hypotheses that simple pre-post studies tend to overestimate CPW effects reported. Out of the 260 primary studies meeting CPW content criteria, only 27 studies met the EPOC study design criteria, with the majority of CPW studies (more than 70 %) excluded from the review on the basis that they were simple pre-post evaluations, mostly comparing two or more annual patient cohorts. Methodologically poor study designs are often used to evaluate CPWs and this compromises the quality of the existing evidence base. Cochrane EPOC methodological criteria, including the selection of rigorous study designs along with detailed descriptions of CPW development and implementation processes, are recommended for quantitative evaluations to improve the evidence base for the use of CPWs in hospitals.

The Advantages and Challenges of Unannounced Standardized Patients Methodology to Assess Healthcare Communication

PubMed Central

Siminoff, Laura A.; Rogers, Heather L.; Waller, Allison C.; Harris-Haywood, Sonja; Esptein, Ronald M.; Borrell Carrio, Francesc; Gliva-McConvey, Gayle; Longo, Daniel R.

2011-01-01

Objective This paper provides an overview of the implementation of using Unannounced Standardized Patients (USPs) to conduct health communication research in clinical settings. Methods Certain types of health communication situations are difficult to capture because of their rarity or unpredictable nature. In primary care the real reasons for a visit are frequently unknown until the consultation is well under way. Therefore, it is logistically difficult for communication studies to capture many real-time communications between patients and their physicians. Although the USP methodology is ideal for capturing these communication behaviors, challenges to using this method include developing collaborative relationships with clinical practices, logistical issues such as safeguarding the identity of the USP, training USPs and creating their identities, maintaining fidelity to the role, and analyzing the resultant data. Results This paper discusses the challenges and solutions to USP implementation. We provide an example of how to implement a USP study using an on-going study being conducted in primary care practices. Conclusion This paper explores the advantages and challenges as well as strategies to overcome obstacles to implementing a USP study. Practice Implications Despite the challenges, USP methodology can contribute much to our understanding of health communication and practice. PMID:21316182

Methodological considerations, such as directed acyclic graphs, for studying "acute on chronic" disease epidemiology: chronic obstructive pulmonary disease example.

PubMed

Tsai, Chu-Lin; Camargo, Carlos A

2009-09-01

Acute exacerbations of chronic disease are ubiquitous in clinical medicine, and thus far, there has been a paucity of integrated methodological discussion on this phenomenon. We use acute exacerbations of chronic obstructive pulmonary disease as an example to emphasize key epidemiological and statistical issues for this understudied field in clinical epidemiology. Directed acyclic graphs are a useful epidemiological tool to explain the differential effects of risk factor on health outcomes in studies of acute and chronic phases of disease. To study the pathogenesis of acute exacerbations of chronic disease, case-crossover design and time-series analysis are well-suited study designs to differentiate acute and chronic effect. Modeling changes over time and setting appropriate thresholds are important steps to separate acute from chronic phases of disease in serial measurements. In statistical analysis, acute exacerbations are recurrent events, and some individuals are more prone to recurrences than others. Therefore, appropriate statistical modeling should take into account intraindividual dependence. Finally, we recommend the use of "event-based" number needed to treat (NNT) to prevent a single exacerbation instead of traditional patient-based NNT. Addressing these methodological challenges will advance research quality in acute on chronic disease epidemiology.

At the cross-roads of participatory research and biomarker discovery in autism: the need for empirical data.

PubMed

Yusuf, Afiqah; Elsabbagh, Mayada

2015-12-15

Identifying biomarkers for autism can improve outcomes for those affected by autism. Engaging the diverse stakeholders in the research process using community-based participatory research (CBPR) can accelerate biomarker discovery into clinical applications. However, there are limited examples of stakeholder involvement in autism research, possibly due to conceptual and practical concerns. We evaluate the applicability of CBPR principles to biomarker discovery in autism and critically review empirical studies adopting these principles. Using a scoping review methodology, we identified and evaluated seven studies using CBPR principles in biomarker discovery. The limited number of studies in biomarker discovery adopting CBPR principles coupled with their methodological limitations suggests that such applications are feasible but challenging. These studies illustrate three CBPR themes: community assessment, setting global priorities, and collaboration in research design. We propose that further research using participatory principles would be useful in accelerating the pace of discovery and the development of clinically meaningful biomarkers. For this goal to be successful we advocate for increased attention to previously identified conceptual and methodological challenges to participatory approaches in health research, including improving scientific rigor and developing long-term partnerships among stakeholders.

Clinical results from a noninvasive blood glucose monitor

NASA Astrophysics Data System (ADS)

Blank, Thomas B.; Ruchti, Timothy L.; Lorenz, Alex D.; Monfre, Stephen L.; Makarewicz, M. R.; Mattu, Mutua; Hazen, Kevin

2002-05-01

Non-invasive blood glucose monitoring has long been proposed as a means for advancing the management of diabetes through increased measurement and control. The use of a near-infrared, NIR, spectroscopy based methodology for noninvasive monitoring has been pursued by a number of groups. The accuracy of the NIR measurement technology is limited by challenges related to the instrumentation, the heterogeneity and time-variant nature of skin tissue, and the complexity of the calibration methodology. In this work, we discuss results from a clinical study that targeted the evaluation of individual calibrations for each subject based on a series of controlled calibration visits. While the customization of the calibrations to individuals was intended to reduce model complexity, the extensive requirements for each individual set of calibration data were difficult to achieve and required several days of measurement. Through the careful selection of a small subset of data from all samples collected on the 138 study participants in a previous study, we have developed a methodology for applying a single standard calibration to multiple persons. The standard calibrations have been applied to a plurality of individuals and shown to be persistent over periods greater than 24 weeks.

Peptides in melanoma therapy.

PubMed

Mocellin, Simone

2012-01-01

Peptides derived from tumor associated antigens can be utilized to elicit a therapeutically effective immune response against melanoma in experimental models. However, patient vaccination with peptides - although it is often followed by the induction of melanoma- specific T lymphocytes - is rarely associated with tumor response of clinical relevance. In this review I summarize the principles of peptide design as well as the results so far obtained in the clinical setting while treating cutaneous melanoma by means of this active immunotherapy strategy. I also discuss some immunological and methodological issues that might be helpful for the successful development of peptide-based vaccines.

Brief functional analysis and treatment of a vocal tic.

PubMed

Watson, T S; Sterling, H E

1998-01-01

This study sought to extend functional methodology to the assessment and treatment of habits. After a descriptive assessment indicated that coughing occurred while eating, a brief functional analysis suggested that social attention was the maintaining variable. Results demonstrated that treatment, derived from the assessment and analysis data, rapidly eliminated the cough. We discuss the appropriateness of using functional analysis procedures for deriving treatments for habits in a clinical setting.

Synthesizing Quantitative Evidence for Evidence-based Nursing: Systematic Review.

PubMed

Oh, Eui Geum

2016-06-01

As evidence-based practice has become an important issue in healthcare settings, the educational needs for knowledge and skills for the generation and utilization of healthcare evidence are increasing. Systematic review (SR), a way of evidence generation, is a synthesis of primary scientific evidence, which summarizes the best evidence on a specific clinical question using a transparent, a priori protocol driven approach. SR methodology requires a critical appraisal of primary studies, data extraction in a reliable and repeatable way, and examination for validity of the results. SRs are considered hierarchically as the highest form of evidence as they are a systematic search, identification, and summarization of the available evidence to answer a focused clinical question with particular attention to the methodological quality of studies or the credibility of opinion and text. The purpose of this paper is to introduce an overview of the fundamental knowledge, principals and processes in SR. The focus of this paper is on SR especially for the synthesis of quantitative data from primary research studies that examines the effectiveness of healthcare interventions. To activate evidence-based nursing care in various healthcare settings, the best and available scientific evidence are essential components. This paper will include some examples to promote understandings. Copyright © 2016. Published by Elsevier B.V.

Clients becoming teachers: Speech-language pathology students' understanding of rehabilitation following clinical practicum in a rehabilitation setting.

PubMed

Attrill, Stacie; Gunn, Simon

2010-04-01

There has been limited research investigating the conceptual development of rehabilitation in speech-language pathology (SLP) students. The aim of this study was to describe SLP students' understanding of rehabilitation following completion of a clinical practicum in a rehabilitation setting. This study was conducted using a qualitative approach according to grounded theory methodology. Semi-structured interviews were conducted with 10 SLP students who had completed a practicum in a rehabilitation setting. Interview data analysis revealed the emergence of five axial categories. Clients becoming teachers was identified as the core category, as the notion that clients were fundamental to students' understanding of rehabilitation occurred reliably throughout the data and related to all other categories. A theoretical model was proposed that demonstrated successive levels of support to students in the acquisition of their understanding of rehabilitation on practicum. Students' understanding of rehabilitation was derived from client-related interactions and factors experienced on practicum in rehabilitation settings. Rehabilitation practicum provided students with a rich and complex learning environment that may facilitate the development of the "core skills" identified for rehabilitation practice.

The Use and Abuse of Diagnostic/Classification Criteria

PubMed Central

June, Rayford R.; Aggarwal, Rohit

2015-01-01

In rheumatic diseases, classification criteria have been developed to identify well-defined homogenous cohorts for clinical research. Although, they are commonly used in clinical practice, their use may not be appropriate for routine diagnostic clinical care. Classification criteria are being revised with improved methodology and further understanding of disease pathophysiology, but still may not encompass all unique clinical situations to be applied for diagnosis of heterogeneous, rare, evolving rheumatic diseases. Diagnostic criteria development is challenging primarily due to difficulty for universal application given significant differences in prevalence of rheumatic diseases based on geographical area and clinic settings. Despite these shortcomings, the clinician can still use classification criteria for understanding the disease as well as a guide for diagnosis with a few caveats. We present the limits of current classification criteria, describe their use and abuse in clinical practice, and how they should be used with caution when applied in clinics. PMID:26096094

Glocal clinical registries: pacemaker registry design and implementation for global and local integration--methodology and case study.

PubMed

da Silva, Kátia Regina; Costa, Roberto; Crevelari, Elizabeth Sartori; Lacerda, Marianna Sobral; de Moraes Albertini, Caio Marcos; Filho, Martino Martinelli; Santana, José Eduardo; Vissoci, João Ricardo Nickenig; Pietrobon, Ricardo; Barros, Jacson V

2013-01-01

The ability to apply standard and interoperable solutions for implementing and managing medical registries as well as aggregate, reproduce, and access data sets from legacy formats and platforms to advanced standard formats and operating systems are crucial for both clinical healthcare and biomedical research settings. Our study describes a reproducible, highly scalable, standard framework for a device registry implementation addressing both local data quality components and global linking problems. We developed a device registry framework involving the following steps: (1) Data standards definition and representation of the research workflow, (2) Development of electronic case report forms using REDCap (Research Electronic Data Capture), (3) Data collection according to the clinical research workflow and, (4) Data augmentation by enriching the registry database with local electronic health records, governmental database and linked open data collections, (5) Data quality control and (6) Data dissemination through the registry Web site. Our registry adopted all applicable standardized data elements proposed by American College Cardiology / American Heart Association Clinical Data Standards, as well as variables derived from cardiac devices randomized trials and Clinical Data Interchange Standards Consortium. Local interoperability was performed between REDCap and data derived from Electronic Health Record system. The original data set was also augmented by incorporating the reimbursed values paid by the Brazilian government during a hospitalization for pacemaker implantation. By linking our registry to the open data collection repository Linked Clinical Trials (LinkedCT) we found 130 clinical trials which are potentially correlated with our pacemaker registry. This study demonstrates how standard and reproducible solutions can be applied in the implementation of medical registries to constitute a re-usable framework. Such approach has the potential to facilitate data integration between healthcare and research settings, also being a useful framework to be used in other biomedical registries.

Molecular diagnosis of symptomatic toxoplasmosis: a 9-year retrospective and prospective study in a referral laboratory in São Paulo, Brazil.

PubMed

Camilo, Lilian Muniz; Pereira-Chioccola, Vera Lucia; Gava, Ricardo; Meira-Strejevitch, Cristina da Silva; Vidal, Jose Ernesto; Brandão de Mattos, Cinara Cássia; Frederico, Fábio Batista; De Mattos, Luiz Carlos; Spegiorin, Lígia Cosentino Junqueira Franco

Symptomatic forms of toxoplasmosis are a serious public health problem and occur in around 10-20% of the infected people. Aiming to improve the molecular diagnosis of symptomatic toxoplasmosis in Brazilian patients, this study evaluated the performance of real time PCR testing two primer sets (B1 and REP-529) in detecting Toxoplasma gondii DNA. The methodology was assayed in 807 clinical samples with known clinical diagnosis, ELISA, and conventional PCR results in a 9-year period. All samples were from patients with clinical suspicion of several features of toxoplasmosis. According to the minimum detection limit curve (in C T ), REP-529 had greater sensitivity to detect T. gondii DNA than B1. Both primer sets were retrospectively evaluated using 515 DNA from different clinical samples. The 122 patients without toxoplasmosis provided high specificity (REP-529, 99.2% and B1, 100%). From the 393 samples with positive ELISA, 146 had clinical diagnosis of toxoplasmosis and positive conventional PCR. REP-529 and B1 sensitivities were 95.9% and 83.6%, respectively. Comparison of REP-529 and B1 performances was further analyzed prospectively in 292 samples. Thus, from a total of 807 DNA analyzed, 217 (26.89%) had positive PCR with, at least one primer set and symptomatic toxoplasmosis confirmed by clinical diagnosis. REP-529 was positive in 97.23%, whereas B1 amplified only 78.80%. After comparing several samples in a Brazilian referral laboratory, this study concluded that REP-529 primer set had better performance than B1 one. These observations were based after using cases with defined clinical diagnosis, ELISA, and conventional PCR. Copyright © 2017 Sociedade Brasileira de Infectologia. Published by Elsevier Editora Ltda. All rights reserved.

A Multilaboratory, Multicountry Study To Determine Bedaquiline MIC Quality Control Ranges for Phenotypic Drug Susceptibility Testing

PubMed Central

Cirillo, Daniela M.; Hoffner, Sven; Ismail, Nazir A.; Kaur, Devinder; Lounis, Nacer; Metchock, Beverly; Pfyffer, Gaby E.; Venter, Amour

2016-01-01

The aim of this study was to establish standardized drug susceptibility testing (DST) methodologies and reference MIC quality control (QC) ranges for bedaquiline, a diarylquinoline antimycobacterial, used in the treatment of adults with multidrug-resistant tuberculosis. Two tier-2 QC reproducibility studies of bedaquiline DST were conducted in eight laboratories using Clinical Laboratory and Standards Institute (CLSI) guidelines. Agar dilution and broth microdilution methods were evaluated. Mycobacterium tuberculosis H37Rv was used as the QC reference strain. Bedaquiline MIC frequency, mode, and geometric mean were calculated. When resulting data occurred outside predefined CLSI criteria, the entire laboratory data set was excluded. For the agar dilution MIC, a 4-dilution QC range (0.015 to 0.12 μg/ml) centered around the geometric mean included 95.8% (7H10 agar dilution; 204/213 observations with one data set excluded) or 95.9% (7H11 agar dilution; 232/242) of bedaquiline MICs. For the 7H9 broth microdilution MIC, a 3-dilution QC range (0.015 to 0.06 μg/ml) centered around the mode included 98.1% (207/211, with one data set excluded) of bedaquiline MICs. Microbiological equivalence was demonstrated for bedaquiline MICs determined using 7H10 agar and 7H11 agar but not for bedaquiline MICs determined using 7H9 broth and 7H10 agar or 7H9 broth and 7H11 agar. Bedaquiline DST methodologies and MIC QC ranges against the H37Rv M. tuberculosis reference strain have been established: 0.015 to 0.12 μg/ml for the 7H10 and 7H11 agar dilution MICs and 0.015 to 0.06 μg/ml for the 7H9 broth microdilution MIC. These methodologies and QC ranges will be submitted to CLSI and EUCAST to inform future research and provide guidance for routine clinical bedaquiline DST in laboratories worldwide. PMID:27654337

Pretesting Qualitative Data Collection Procedures to Facilitate Methodological Adherence and Team Building in Nigeria.

PubMed

Hurst, Samantha; Arulogun, Oyedunni S; Owolabi, Ayowa O; Akinyemi, Rufus; Uvere, Ezinne; Warth, Stephanie; Ovbiagele, Bruce

Qualitative methods are becoming widely used and increasingly accepted in biomedical research involving teams formed by experts from developing and developed practice environments. Resources are rare in offering guidance on how to surmount challenges of team integration and resolution of complicated logistical issues in a global setting. In this article we present a critical reflection of lessons learned and necessary steps taken to achieve methodological coherence and international team synergy. A series of 10 pretest interviews were conducted to assess instrumentation rigor and formulate measures to address any limitations or threats to bias and management procedures before carrying out the formal phase of qualitative research, contributing to an evidence-based stroke-preventive care clinical trial study. The experience of pretesting notably helped to identify obstacles and thus increase the methodological and social reliability central to conducting credible qualitative research, while also ensuring both personal and professional fulfillment of our team members.

The Human Microbiome and Understanding the 16S rRNA Gene in Translational Nursing Science

PubMed Central

Ames, Nancy J.; Ranucci, Alexandra; Moriyama, Brad; Wallen, Gwenyth R.

2017-01-01

Background As more is understood regarding the human microbiome, it is increasingly important for nurse scientists and health care practitioners to analyze these microbial communities and their role in health and disease.16S rRNA sequencing is a key methodology in identifying these bacterial populations that has recently transitioned from use primarily in research to having increased utility in clinical settings. Objectives The objectives of this review are to: (a) describe 16S rRNA sequencing and its role in answering research questions important to nursing science; (b) provide an overview of the oral, lung and gut microbiomes and relevant research; and (c) identify future implications for microbiome research and 16S sequencing in translational nursing science. Discussion Sequencing using the 16S rRNA gene has revolutionized research and allowed scientists to easily and reliably characterize complex bacterial communities. This type of research has recently entered the clinical setting, one of the best examples involving the use of 16S sequencing to identify resistant pathogens, thereby improving the accuracy of bacterial identification in infection control. Clinical microbiota research and related requisite methods are of particular relevance to nurse scientists—individuals uniquely positioned to utilize these techniques in future studies in clinical settings. PMID:28252578

Video observation in HIT development: lessons learned on benefits and challenges.

PubMed

Høstgaard, Anna Marie; Bertelsen, Pernille

2012-08-22

Experience shows that the precondition for the development of successful health information technologies is a thorough insight into clinical work practice. In contemporary clinical work practice, clinical work and health information technology are integrated, and part of the practice is tacit. When work practice becomes routine, it slips to the background of the conscious awareness and becomes difficult to recognize without the context to support recall. This means that it is difficult to capture with traditional ethnographic research methods or in usability laboratories or clinical set ups. Observation by the use of the video technique within healthcare settings has proven to be capable of providing a thorough insight into the complex clinical work practice and its context - including parts of the tacit practice. The objective of this paper is 1) to argue for the video observation technique to inform and improve health-information-technology development and 2) to share insights and lessons learned on benefits and challenges when using the video observation technique within healthcare settings. A multiple case study including nine case studies conducted by DaCHI researchers 2004-2011 using audio-visual, non-participant video observation for data collection within different healthcare settings. In HIT development, video observation is beneficial for 1) informing and improving system design 2) studying changes in work practice 3) identifying new potentials and 4) documenting current work practices. The video observation technique used within healthcare settings is superior to other ethnographic research methods when it comes to disclosing the complexity in clinical work practice. The insights gained are far more realistic compared to traditional ethnographic studies or usability studies and studies in clinical set ups. Besides, the data generated through video recordings provide a solid basis for dialog between the health care professionals involved. The most important lessons learned are that a well considered methodology and clear formulated objectives are imperative, in order to stay focused during the data rich analysis phase. Additionally, the video observation technique is primarily recommended for studies of specific clinical work practices within delimited clinical settings. Overall, the video observation technique has proven to be capable of improving our understanding of the interwoven relation between clinical work practice and HIT and to inform us about user requirements and needs for HIT, which is a precondition for the development of more successful HIT systems in the future.

Web-based international studies in limited populations of pediatric leukemia.

PubMed

Valsecchi, Maria Grazia; Silvestri, Daniela; Covezzoli, Anna; De Lorenzo, Paola

2008-02-01

Recent progress in cancer research leads to the characterization of small subgroups of patients by genetic/biological features. Clinical studies in this setting are frequently promoted by international networks of independent researchers and are limited by practical and methodological constraints, not least the regulations recently issued by national and international institutions (EU Directive 2001/20/EC). We reviewed various methods in the design of international multicenter studies, with focus on randomized clinical trials. This paper reports our experience in planning and conducting international studies in childhood leukemia. We applied a decentralized study conduct based on a two-level structure, comprising a national and an international coordinating level. For the more recent trials this structure was implemented as a web-based system. This approach accommodates major legal requirements (e.g., safety reporting) and ensures Good Clinical Practice principles by implementing risk-oriented monitoring procedures. Setting up international non-commercial trials is increasingly complicated. Still, they are strongly needed for answering relevant questions in limited populations. (c) 2007 Wiley-Liss, Inc.

Platelet Aggregometry Testing: Molecular Mechanisms, Techniques and Clinical Implications

PubMed Central

Koltai, Katalin; Kesmarky, Gabor; Feher, Gergely; Tibold, Antal

2017-01-01

Platelets play a fundamental role in normal hemostasis, while their inherited or acquired dysfunctions are involved in a variety of bleeding disorders or thrombotic events. Several laboratory methodologies or point-of-care testing methods are currently available for clinical and experimental settings. These methods describe different aspects of platelet function based on platelet aggregation, platelet adhesion, the viscoelastic properties during clot formation, the evaluation of thromboxane metabolism or certain flow cytometry techniques. Platelet aggregometry is applied in different clinical settings as monitoring response to antiplatelet therapies, the assessment of perioperative bleeding risk, the diagnosis of inherited bleeding disorders or in transfusion medicine. The rationale for platelet function-driven antiplatelet therapy was based on the result of several studies on patients undergoing percutaneous coronary intervention (PCI), where an association between high platelet reactivity despite P2Y12 inhibition and ischemic events as stent thrombosis or cardiovascular death was found. However, recent large scale randomized, controlled trials have consistently failed to demonstrate a benefit of personalised antiplatelet therapy based on platelet function testing. PMID:28820484

A method to optimize the processing algorithm of a computed radiography system for chest radiography.

PubMed

Moore, C S; Liney, G P; Beavis, A W; Saunderson, J R

2007-09-01

A test methodology using an anthropomorphic-equivalent chest phantom is described for the optimization of the Agfa computed radiography "MUSICA" processing algorithm for chest radiography. The contrast-to-noise ratio (CNR) in the lung, heart and diaphragm regions of the phantom, and the "system modulation transfer function" (sMTF) in the lung region, were measured using test tools embedded in the phantom. Using these parameters the MUSICA processing algorithm was optimized with respect to low-contrast detectability and spatial resolution. Two optimum "MUSICA parameter sets" were derived respectively for maximizing the CNR and sMTF in each region of the phantom. Further work is required to find the relative importance of low-contrast detectability and spatial resolution in chest images, from which the definitive optimum MUSICA parameter set can then be derived. Prior to this further work, a compromised optimum MUSICA parameter set was applied to a range of clinical images. A group of experienced image evaluators scored these images alongside images produced from the same radiographs using the MUSICA parameter set in clinical use at the time. The compromised optimum MUSICA parameter set was shown to produce measurably better images.

A Design Methodology for Medical Processes

PubMed Central

Bonacina, Stefano; Pozzi, Giuseppe; Pinciroli, Francesco; Marceglia, Sara

2016-01-01

Summary Background Healthcare processes, especially those belonging to the clinical domain, are acknowledged as complex and characterized by the dynamic nature of the diagnosis, the variability of the decisions made by experts driven by their experiences, the local constraints, the patient’s needs, the uncertainty of the patient’s response, and the indeterminacy of patient’s compliance to treatment. Also, the multiple actors involved in patient’s care need clear and transparent communication to ensure care coordination. Objectives In this paper, we propose a methodology to model healthcare processes in order to break out complexity and provide transparency. Methods The model is grounded on a set of requirements that make the healthcare domain unique with respect to other knowledge domains. The modeling methodology is based on three main phases: the study of the environmental context, the conceptual modeling, and the logical modeling. Results The proposed methodology was validated by applying it to the case study of the rehabilitation process of stroke patients in the specific setting of a specialized rehabilitation center. The resulting model was used to define the specifications of a software artifact for the digital administration and collection of assessment tests that was also implemented. Conclusions Despite being only an example, our case study showed the ability of process modeling to answer the actual needs in healthcare practices. Independently from the medical domain in which the modeling effort is done, the proposed methodology is useful to create high-quality models, and to detect and take into account relevant and tricky situations that can occur during process execution. PMID:27081415

Defining a reference set to support methodological research in drug safety.

PubMed

Ryan, Patrick B; Schuemie, Martijn J; Welebob, Emily; Duke, Jon; Valentine, Sarah; Hartzema, Abraham G

2013-10-01

Methodological research to evaluate the performance of methods requires a benchmark to serve as a referent comparison. In drug safety, the performance of analyses of spontaneous adverse event reporting databases and observational healthcare data, such as administrative claims and electronic health records, has been limited by the lack of such standards. To establish a reference set of test cases that contain both positive and negative controls, which can serve the basis for methodological research in evaluating methods performance in identifying drug safety issues. Systematic literature review and natural language processing of structured product labeling was performed to identify evidence to support the classification of drugs as either positive controls or negative controls for four outcomes: acute liver injury, acute kidney injury, acute myocardial infarction, and upper gastrointestinal bleeding. Three-hundred and ninety-nine test cases comprised of 165 positive controls and 234 negative controls were identified across the four outcomes. The majority of positive controls for acute kidney injury and upper gastrointestinal bleeding were supported by randomized clinical trial evidence, while the majority of positive controls for acute liver injury and acute myocardial infarction were only supported based on published case reports. Literature estimates for the positive controls shows substantial variability that limits the ability to establish a reference set with known effect sizes. A reference set of test cases can be established to facilitate methodological research in drug safety. Creating a sufficient sample of drug-outcome pairs with binary classification of having no effect (negative controls) or having an increased effect (positive controls) is possible and can enable estimation of predictive accuracy through discrimination. Since the magnitude of the positive effects cannot be reliably obtained and the quality of evidence may vary across outcomes, assumptions are required to use the test cases in real data for purposes of measuring bias, mean squared error, or coverage probability.

An automatic panoramic image reconstruction scheme from dental computed tomography images

PubMed Central

Papakosta, Thekla K; Savva, Antonis D; Economopoulos, Theodore L; Gröhndal, H G

2017-01-01

Objectives: Panoramic images of the jaws are extensively used for dental examinations and/or surgical planning because they provide a general overview of the patient's maxillary and mandibular regions. Panoramic images are two-dimensional projections of three-dimensional (3D) objects. Therefore, it should be possible to reconstruct them from 3D radiographic representations of the jaws, produced by CBCT scanning, obviating the need for additional exposure to X-rays, should there be a need of panoramic views. The aim of this article is to present an automated method for reconstructing panoramic dental images from CBCT data. Methods: The proposed methodology consists of a series of sequential processing stages for detecting a fitting dental arch which is used for projecting the 3D information of the CBCT data to the two-dimensional plane of the panoramic image. The detection is based on a template polynomial which is constructed from a training data set. Results: A total of 42 CBCT data sets of real clinical pre-operative and post-operative representations from 21 patients were used. Eight data sets were used for training the system and the rest for testing. Conclusions: The proposed methodology was successfully applied to CBCT data sets, producing corresponding panoramic images, suitable for examining pre-operatively and post-operatively the patients' maxillary and mandibular regions. PMID:28112548

Validation of quality indicators for the organization of palliative care: a modified RAND Delphi study in seven European countries (the Europall project).

PubMed

Woitha, Kathrin; Van Beek, Karen; Ahmed, Nisar; Jaspers, Birgit; Mollard, Jean M; Ahmedzai, Sam H; Hasselaar, Jeroen; Menten, Johan; Vissers, Kris; Engels, Yvonne

2014-02-01

Validated quality indicators can help health-care professionals to evaluate their medical practices in a comparative manner to deliver optimal clinical care. No international set of quality indicators to measure the organizational aspects of palliative care settings exists. To develop and validate a set of structure and process indicators for palliative care settings in Europe. A two-round modified RAND Delphi process was conducted to rate clarity and usefulness of a previously developed set of 110 quality indicators. In total, 20 multi-professional palliative care teams of centers of excellence from seven European countries. In total, 56 quality indicators were rated as useful. These valid quality indicators concerned the following domains: the definition of a palliative care service (2 quality indicators), accessibility to palliative care (16 quality indicators), specific infrastructure to deliver palliative care (8 quality indicators), symptom assessment tools (1 quality indicator), specific personnel in palliative care services (9 quality indicators), documentation methodology of clinical data (14 quality indicators), evaluation of quality and safety procedures (1 quality indicator), reporting of clinical activities (1 quality indicator), and education in palliative care (4 quality indicator). The modified RAND Delphi process resulted in 56 international face-validated quality indicators to measure and compare organizational aspects of palliative care. These quality indicators, aimed to assess and improve the organization of palliative care, will be pilot tested in palliative care settings all over Europe and be used in the EU FP7 funded IMPACT project.

Molecular diagnosis of cryptococcal meningitis in cerebrospinal fluid: comparison of primer sets for Cryptococcus neoformans and Cryptococcus gattii species complex.

PubMed

Martins, Marilena dos Anjos; Brighente, Kate Bastos Santos; Matos, Terezinha Aparecida de; Vidal, Jose Ernesto; Hipólito, Daise Damaris Carnietto de; Pereira-Chioccola, Vera Lucia

2015-01-01

This study evaluated the use of polymerase chain reaction for cryptococcal meningitis diagnosis in clinical samples. The sensitivity and specificity of the methodology were evaluated using eight Cryptococcus neoformans/C. gattii species complex reference strains and 165 cerebrospinal fluid samples from patients with neurological diseases divided into two groups: 96 patients with cryptococcal meningitis and AIDS; and 69 patients with other neurological opportunistic diseases (CRL/AIDS). Two primer sets were tested (CN4-CN5 and the multiplex CNa70S-CNa70A/CNb49S-CNb-49A that amplify a specific product for C. neoformans and another for C. gattii). CN4-CN5 primer set was positive in all Cryptococcus standard strains and in 94.8% in DNA samples from cryptococcal meningitis and AIDS group. With the multiplex, no 448-bp product of C. gattii was observed in the clinical samples of either group. The 695bp products of C. neoformans were observed only in 64.6% of the cryptococcal meningitis and AIDS group. This primer set was negative for two standard strains. The specificity based on the negative samples from the CTL/AIDS group was 98.5% in both primer sets. These data suggest that the CN4/CN5 primer set was highly sensitive for the identification of C. neoformans/C. gattii species complex in cerebrospinal fluid samples from patients with clinical suspicion of cryptococcal meningitis. Copyright © 2014 Elsevier Editora Ltda. All rights reserved.

A reference case for economic evaluations in osteoarthritis: an expert consensus article from the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO).

PubMed

Hiligsmann, Mickaël; Cooper, Cyrus; Guillemin, Francis; Hochberg, Marc C; Tugwell, Peter; Arden, Nigel; Berenbaum, Francis; Boers, Maarten; Boonen, Annelies; Branco, Jaime C; Maria-Luisa, Brandi; Bruyère, Olivier; Gasparik, Andrea; Kanis, John A; Kvien, Tore K; Martel-Pelletier, Johanne; Pelletier, Jean-Pierre; Pinedo-Villanueva, Rafael; Pinto, Daniel; Reiter-Niesert, Susanne; Rizzoli, René; Rovati, Lucio C; Severens, Johan L; Silverman, Stuart; Reginster, Jean-Yves

2014-12-01

General recommendations for a reference case for economic studies in rheumatic diseases were published in 2002 in an initiative to improve the comparability of cost-effectiveness studies in the field. Since then, economic evaluations in osteoarthritis (OA) continue to show considerable heterogeneity in methodological approach. To develop a reference case specific for economic studies in OA, including the standard optimal care, with which to judge new pharmacologic and non-pharmacologic interventions. Four subgroups of an ESCEO expert working group on economic assessments (13 experts representing diverse aspects of clinical research and/or economic evaluations) were charged with producing lists of recommendations that would potentially improve the comparability of economic analyses in OA: outcome measures, comparators, costs and methodology. These proposals were discussed and refined during a face-to-face meeting in 2013. They are presented here in the format of the recommendations of the recently published Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement, so that an initiative on economic analysis methodology might be consolidated with an initiative on reporting standards. Overall, three distinct reference cases are proposed, one for each hand, knee and hip OA; with diagnostic variations in the first two, giving rise to different treatment options: interphalangeal or thumb-based disease for hand OA and the presence or absence of joint malalignment for knee OA. A set of management strategies is proposed, which should be further evaluated to help establish a consensus on the "standard optimal care" in each proposed reference case. The recommendations on outcome measures, cost itemisation and methodological approaches are also provided. The ESCEO group proposes a set of disease-specific recommendations on the conduct and reporting of economic evaluations in OA that could help the standardisation and comparability of studies that evaluate therapeutic strategies of OA in terms of costs and effectiveness. Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.

Balancing power: A grounded theory study on partnership of academic service institutes.

PubMed

Heshmati Nabavi, Fatemeh; Vanaki, Zohreh; Mohammadi, Eesa; Yazdani, Shahram

2017-07-01

Governments and professional organizations have called for new partnerships between health care providers and academics to improve clinical education for the benefit of both students and patients. To develop a substantive grounded theory on the process of forming academic-service partnerships in implementing clinical education, from the perspective of academic and clinical nursing staff members and managers working in Iranian settings. The participants included 15 hospital nurses, nurse managers, nurse educators, and educational managers from two central universities and clinical settings from 2009 to 2012. Data were collected through 30 in-depth, semi-structure interviews with the individual participants and then analyzed using the methodology of Strauss and Corbin's grounded theory. Utilizing "balancing power" as the core variable enabled us to integrate the concepts concerning the partnership processes between clinical and educational institutes. Three distinct and significant categories emerged to explain the process of partnership: 1) divergence, 2) conflict between educational and caring functions, and 3) creation of balance between educational and caring functions. In implementing clinical education, partnerships have been formed within a challenging context in Iran. Conflict between clinical and educational functions was the main concern of both sides of the partnership in forming a collaborative relationship, with our findings emphasizing the importance of nursing educators' role in the establishment of partnership programs.

Methodological considerations in the design and implementation of clinical trials.

PubMed

Cirrincione, Constance T; Lavoie Smith, Ellen M; Pang, Herbert

2014-02-01

To review study design issues related to clinical trials led by oncology nurses, with special attention to those conducted within the cooperative group setting; to emphasize the importance of the statistician's role in the process of clinical trials. Studies available at clinicaltrials.gov using experimental designs that have been published in peer-reviewed journals; cooperative group trials are highlighted. The clinical trial is a primary means to test intervention efficacy. A properly designed and powered study with clear and measurable objectives is as important as the intervention itself. Collaboration among the study team, including the statistician, is central in developing and conducting appropriately designed studies. For optimal results, collaboration is an ongoing process that should begin early on. Copyright © 2014 Elsevier Inc. All rights reserved.

The CONSENSUS study: protocol for a mixed methods study to establish which outcomes should be included in a core outcome set for oropharyngeal cancer.

PubMed

Waters, Aoife Mi; Tudur Smith, Catrin; Young, Bridget; Jones, Terry M

2014-05-13

The incidence of oropharyngeal cancer is increasing in the developed world. This has led to a large rise in research activity and clinical trials in this area, yet there is no consensus on which outcomes should be measured. As a result, the outcomes measured often differ between trials of comparable interventions, making the combination or comparison of results between trials impossible. Outcomes may also be 'cherry-picked', such that favourable results are reported, and less favourable results withheld. The development of a minimum outcome reporting standard, known as a core outcome set, goes some way to addressing these problems. Core outcome sets are ideally developed using a patient-centred approach so that the outcomes measured are relevant to patients and clinical practice. Core outcome sets drive up the quality and relevance of research by ensuring that the right outcomes are consistently measured and reported in trials in specific areas of health or healthcare. This is a mixed methods study involving three phases to develop a core outcome set for oropharyngeal cancer clinical trials. Firstly, a systematic review will establish which outcomes are measured in published oropharyngeal cancer randomised controlled trials (RCTs). Secondly, qualitative interviews with patients and carers in the UK and the USA will aim to establish which outcomes are important to these stakeholders. Data from these first two stages will be used to develop a comprehensive list of outcomes to be considered for inclusion in the core outcome set. In the third stage, patients and clinicians will participate in an iterative consensus exercise known as a Delphi study to refine the contents of the core outcome set. This protocol lays out the methodology to be implemented in the CONSENSUS study. A core outcome set defines a minimum outcome reporting standard for clinical trials in a particular area of health or healthcare. Its consistent implementation in oropharyngeal cancer clinical trials will improve the quality and relevance of research. This study is registered at the National Institute for Health Research (NIHR) Clinical Research Network (CRN) portfolio, ID 13823 (17 January 2013).

The CONSENSUS study: protocol for a mixed methods study to establish which outcomes should be included in a core outcome set for oropharyngeal cancer

PubMed Central

2014-01-01

Background The incidence of oropharyngeal cancer is increasing in the developed world. This has led to a large rise in research activity and clinical trials in this area, yet there is no consensus on which outcomes should be measured. As a result, the outcomes measured often differ between trials of comparable interventions, making the combination or comparison of results between trials impossible. Outcomes may also be ‘cherry-picked’, such that favourable results are reported, and less favourable results withheld. The development of a minimum outcome reporting standard, known as a core outcome set, goes some way to addressing these problems. Core outcome sets are ideally developed using a patient-centred approach so that the outcomes measured are relevant to patients and clinical practice. Core outcome sets drive up the quality and relevance of research by ensuring that the right outcomes are consistently measured and reported in trials in specific areas of health or healthcare. Methods/Design This is a mixed methods study involving three phases to develop a core outcome set for oropharyngeal cancer clinical trials. Firstly, a systematic review will establish which outcomes are measured in published oropharyngeal cancer randomised controlled trials (RCTs). Secondly, qualitative interviews with patients and carers in the UK and the USA will aim to establish which outcomes are important to these stakeholders. Data from these first two stages will be used to develop a comprehensive list of outcomes to be considered for inclusion in the core outcome set. In the third stage, patients and clinicians will participate in an iterative consensus exercise known as a Delphi study to refine the contents of the core outcome set. This protocol lays out the methodology to be implemented in the CONSENSUS study. Discussion A core outcome set defines a minimum outcome reporting standard for clinical trials in a particular area of health or healthcare. Its consistent implementation in oropharyngeal cancer clinical trials will improve the quality and relevance of research. Trials and registration This study is registered at the National Institute for Health Research (NIHR) Clinical Research Network (CRN) portfolio, ID 13823 (17 January 2013). PMID:24885068

Benefits of remote real-time side-effect monitoring systems for patients receiving cancer treatment.

PubMed

Kofoed, Sarah; Breen, Sibilah; Gough, Karla; Aranda, Sanchia

2012-03-05

In Australia, the incidence of cancer diagnoses is rising along with an aging population. Cancer treatments, such as chemotherapy, are increasingly being provided in the ambulatory care setting. Cancer treatments are commonly associated with distressing and serious side-effects and patients often struggle to manage these themselves without specialized real-time support. Unlike chronic disease populations, few systems for the remote real-time monitoring of cancer patients have been reported. However, several prototype systems have been developed and have received favorable reports. This review aimed to identify and detail systems that reported statistical analyses of changes in patient clinical outcomes, health care system usage or health economic analyses. Five papers were identified that met these criteria. There was wide variation in the design of the monitoring systems in terms of data input method, clinician alerting and response, groups of patients targeted and clinical outcomes measured. The majority of studies had significant methodological weaknesses. These included no control group comparisons, small sample sizes, poor documentation of clinical interventions or measures of adherence to the monitoring systems. In spite of the limitations, promising results emerged in terms of improved clinical outcomes (e.g. pain, depression, fatigue). Health care system usage was assessed in two papers with inconsistent results. No studies included health economic analyses. The diversity in systems described, outcomes measured and methodological issues all limited between-study comparisons. Given the acceptability of remote monitoring and the promising outcomes from the few studies analyzing patient or health care system outcomes, future research is needed to rigorously trial these systems to enable greater patient support and safety in the ambulatory setting.

Benefits of remote real-time side-effect monitoring systems for patients receiving cancer treatment

PubMed Central

Kofoed, Sarah; Breen, Sibilah; Gough, Karla; Aranda, Sanchia

2012-01-01

In Australia, the incidence of cancer diagnoses is rising along with an aging population. Cancer treatments, such as chemotherapy, are increasingly being provided in the ambulatory care setting. Cancer treatments are commonly associated with distressing and serious side-effects and patients often struggle to manage these themselves without specialized real-time support. Unlike chronic disease populations, few systems for the remote real-time monitoring of cancer patients have been reported. However, several prototype systems have been developed and have received favorable reports. This review aimed to identify and detail systems that reported statistical analyses of changes in patient clinical outcomes, health care system usage or health economic analyses. Five papers were identified that met these criteria. There was wide variation in the design of the monitoring systems in terms of data input method, clinician alerting and response, groups of patients targeted and clinical outcomes measured. The majority of studies had significant methodological weaknesses. These included no control group comparisons, small sample sizes, poor documentation of clinical interventions or measures of adherence to the monitoring systems. In spite of the limitations, promising results emerged in terms of improved clinical outcomes (e.g. pain, depression, fatigue). Health care system usage was assessed in two papers with inconsistent results. No studies included health economic analyses. The diversity in systems described, outcomes measured and methodological issues all limited between-study comparisons. Given the acceptability of remote monitoring and the promising outcomes from the few studies analyzing patient or health care system outcomes, future research is needed to rigorously trial these systems to enable greater patient support and safety in the ambulatory setting. PMID:25992209

Multimedia platform for authoring and presentation of clinical rounds in cardiology

NASA Astrophysics Data System (ADS)

Ratib, Osman M.; Allada, Vivekanand; Dahlbom, Magdalena; Lapstra, Lorelle

2003-05-01

We developed a multimedia presentation platform that allows retrieving data from any digital and analog modalities and to prepare a script of a clinical presentation in an XML format. This system was designed for cardiac multi-disciplinary conferences involving different cardiology specialists as well as cardiovascular surgeons. A typical presentation requires preparation of summary reports of data obtained from the different investigations and imaging techniques. An XML-based scripting methodology was developed to allow for preparation of clinical presentations. The image display program uses the generated script for the sequential presentation of different images that are displayed on pre-determined presentation settings. The ability to prepare and present clinical conferences electronically is more efficient and less time consuming than conventional settings using analog and digital documents, films and videotapes. The script of a given presentation can further be saved as part of the patient record for subsequent review of the documents and images that supported a given medical or therapeutic decision. This also constitutes a perfect documentation method for surgeons and physicians responsible of therapeutic procedures that were decided upon during the clinical conference. It allows them to review the relevant data that supported a given therapeutic decision.

Use of Smartphones for Clinical and Medical Education.

PubMed

Valle, Jazmine; Godby, Tyler; Paul, David P; Smith, Harlan; Coustasse, Alberto

Smartphone use in clinical settings and in medical education has been on the rise, benefiting both health care and health care providers. Studies have shown, however, that some health care facilities and providers are reluctant to switch to smartphones due to the threat of mixing personal apps with clinical care applications and the possibility that distraction created by smartphone use could lead to medication errors and errors linked to procedures, treatments, or tests. The purpose of this research was to examine the effects of smartphones in a clinical setting and for medical education, to determine their overall impact. The methodology for this qualitative study was a literature review, conducted over five electronic databases. The search was limited to articles published in English, between 2010 and 2016. Forty-one sources that focused on the implementation of and the barriers to use of smartphones in clinical and medical education environments were referenced. These studies revealed that smartphones have more positive than negative effects on the ability to enhance patient care and medical education. Smartphone use is clearly an effective and efficient method of enhancing patient care and medical education in the health care industry. Access to health care as well is enhanced by the use of this tool.

Current methodological approaches in conditioned pain modulation assessment in pediatrics

PubMed Central

Hwang, Philippe S; Ma, My-Linh; Spiegelberg, Nora; Ferland, Catherine E

2017-01-01

Conditioned pain modulation (CPM) paradigms have been used in various studies with healthy and non-healthy adult populations in an attempt to elucidate the mechanisms of pain processing. However, only a few studies so far have applied CPM in pediatric populations. Studies finding associations with chronic pain conditions suggest that deficiencies in underlying descending pain pathways may play an important role in the development and persistence of pain early in life. Twelve studies were identified using a PubMed search which examine solely pediatric populations, and these are reviewed with regard to demographics studied, methodological approaches, and conclusions reached. This review aimed to provide both clinicians and researchers with a brief overview of the current state of research regarding the use of CPM in children and adolescents, both healthy and clinical patients. The implications of CPM in experimental and clinical settings and its potential to aid in refining considerations to individualize treatment of pediatric pain syndromes will be discussed. PMID:29263694

Methodology for clinical trials involving patients with cancer who have febrile neutropenia: updated guidelines of the Immunocompromised Host Society/Multinational Association for Supportive Care in Cancer, with emphasis on outpatient studies.

PubMed

Feld, Ronald; Paesmans, Marianne; Freifeld, Alison G; Klastersky, Jean; Pizzo, Philip A; Rolston, Kenneth V I; Rubenstein, Edward; Talcott, James A; Walsh, Thomas J

2002-12-15

Two multinational organizations, the Immunocompromised Host Society and the Multinational Association for Supportive Care in Cancer, have produced for investigators and regulatory bodies a set of guidelines on methodology for clinical trials involving patients with febrile neutropenia. The guidelines suggest that response (i.e., success of initial empirical antibiotic therapy without any modification) be determined at 72 h and again on day 5, and the reasons for modification should be stated. Blinding and stratification are to be encouraged, as should statistical consideration of trials specifically designed for showing equivalence. Patients enrolled in outpatient studies should be selected by use of a validated risk model, and patients should be carefully monitored after discharge from the hospital. Response and safety parameters should be recorded along with readmission rates. If studies use these guidelines, comparisons between studies will be simpler and will lead to further improvements in patient therapy.

Developing Methodologies to Find Abbreviated Laboratory Test Names in Narrative Clinical Documents by Generating High Quality Q-Grams.

PubMed

Kim, Kyungmo; Choi, Jinwook

2017-01-01

Laboratory test names are used as basic information to diagnose diseases. However, this kind of medical information is usually written in a natural language. To find this information, lexicon based methods have been good solutions but they cannot find terms that do not have abbreviated expressions, such as "neuts" that means "neutrophils". To address this issue, similar word matching can be used; however, it can be disadvantageous because of significant false positives. Moreover, processing time is longer as the size of terms is bigger. Therefore, we suggest a novel q-gram based algorithm, named modified triangular area filtering, to find abbreviated laboratory test terms in clinical documents, minimizing the possibility to impair the lexicons' precision. In addition, we found the terms using the methodology with reasonable processing time. The results show that this method can achieve 92.54 precision, 87.72 recall, 90.06 f1-score in test sets when edit distance threshold(τ) = 3.

Retinal vessel tortuosity measures and their applications.

PubMed

Kalitzeos, Angelos A; Lip, Gregory Y H; Heitmar, Rebekka

2013-01-01

Structural retinal vascular characteristics, such as vessel calibers, tortuosity and bifurcation angles are increasingly quantified in an objective manner, slowly replacing subjective qualitative disease classification schemes. This paper provides an overview of the current methodologies and calculations used to compute retinal vessel tortuosity. We set out the different parameter calculations and provide an insight into the clinical applications, while critically reviewing its pitfalls and shortcomings. Copyright © 2012 Elsevier Ltd. All rights reserved.

[Groups of female workers with lowered adaptation to the working conditions in footwear industry].

PubMed

Datsenko, M F; Poguda, A A; Nuromskaia, O A

1991-01-01

The Republican Centre for Occupational Diseases was set in Estonia in 1971. The Centre performs administrative and methodological guidance for the republican clinical institutions in diagnostics, prevention and treatment of occupational diseases. The Centre also runs an out-patient department and a 40-bed in-patient stationary. In the occupational diseases structure, communicable diseases are prevalent (particularly, erysipeloid), followed by occupational hypoacusis, vibration related and allergic diseases.

A literature review of applied adaptive design methodology within the field of oncology in randomised controlled trials and a proposed extension to the CONSORT guidelines.

PubMed

Mistry, Pankaj; Dunn, Janet A; Marshall, Andrea

2017-07-18

The application of adaptive design methodology within a clinical trial setting is becoming increasingly popular. However the application of these methods within trials is not being reported as adaptive designs hence making it more difficult to capture the emerging use of these designs. Within this review, we aim to understand how adaptive design methodology is being reported, whether these methods are explicitly stated as an 'adaptive design' or if it has to be inferred and to identify whether these methods are applied prospectively or concurrently. Three databases; Embase, Ovid and PubMed were chosen to conduct the literature search. The inclusion criteria for the review were phase II, phase III and phase II/III randomised controlled trials within the field of Oncology that published trial results in 2015. A variety of search terms related to adaptive designs were used. A total of 734 results were identified, after screening 54 were eligible. Adaptive designs were more commonly applied in phase III confirmatory trials. The majority of the papers performed an interim analysis, which included some sort of stopping criteria. Additionally only two papers explicitly stated the term 'adaptive design' and therefore for most of the papers, it had to be inferred that adaptive methods was applied. Sixty-five applications of adaptive design methods were applied, from which the most common method was an adaptation using group sequential methods. This review indicated that the reporting of adaptive design methodology within clinical trials needs improving. The proposed extension to the current CONSORT 2010 guidelines could help capture adaptive design methods. Furthermore provide an essential aid to those involved with clinical trials.

Three models of community mental health services In low-income countries

PubMed Central

2011-01-01

Objective To compare and contrast three models of community mental health services in low-income settings. Data Sources/Study Setting Primary and secondary data collected before, during, and after site visits to mental health programs in Nigeria, the Philippines, and India. Study Design Qualitative case study methodology. Data Collection Data were collected through interviews and observations during site visits to the programs, as well as from reviews of documentary evidence. Principal Findings A set of narrative topics and program indicators were used to compare and contrast three community mental health programs in low-income countries. This allowed us to identify a diversity of service delivery models, common challenges, and the strengths and weaknesses of each program. More definitive evaluations will require the establishment of data collection methods and information systems that provide data about the clinical and social outcomes of clients, as well as their use of services. Conclusions Community mental health programs in low-income countries face a number of challenges. Using a case study methodology developed for this purpose, it is possible to compare programs and begin to assess the effectiveness of diverse service delivery models. PMID:21266051

METHODOLOGICAL QUALITY OF ECONOMIC EVALUATIONS ALONGSIDE TRIALS OF KNEE PHYSIOTHERAPY.

PubMed

García-Pérez, Lidia; Linertová, Renata; Arvelo-Martín, Alejandro; Guerra-Marrero, Carolina; Martínez-Alberto, Carlos Enrique; Cuéllar-Pompa, Leticia; Escobar, Antonio; Serrano-Aguilar, Pedro

2017-01-01

The methodological quality of an economic evaluation performed alongside a clinical trial can be underestimated if the paper does not report key methodological features. This study discusses methodological assessment issues on the example of a systematic review on cost-effectiveness of physiotherapy for knee osteoarthritis. Six economic evaluation studies included in the systematic review and related clinical trials were assessed using the 10-question check-list by Drummond and the Physiotherapy Evidence Database (PEDro) scale. All economic evaluations were performed alongside a clinical trial but the studied interventions were too heterogeneous to be synthesized. Methodological quality of the economic evaluations reported in the papers was not free of drawbacks, and in some cases, it improved when information from the related clinical trial was taken into account. Economic evaluation papers dedicate little space to methodological features of related clinical trials; therefore, the methodological quality can be underestimated if evaluated separately from the trials. Future economic evaluations should follow more strictly the recommendations about methodology and the authors should pay special attention to the quality of reporting.

A methodology for evaluation of a markup-based specification of clinical guidelines.

PubMed

Shalom, Erez; Shahar, Yuval; Taieb-Maimon, Meirav; Lunenfeld, Eitan

2008-11-06

We introduce a three-phase, nine-step methodology for specification of clinical guidelines (GLs) by expert physicians, clinical editors, and knowledge engineers, and for quantitative evaluation of the specification's quality. We applied this methodology to a particular framework for incremental GL structuring (mark-up) and to GLs in three clinical domains with encouraging results.

Mental Imagery: Functional Mechanisms and Clinical Applications

PubMed Central

Pearson, Joel; Naselaris, Thomas; Holmes, Emily A.; Kosslyn, Stephen M.

2015-01-01

Mental imagery research has weathered both disbelief of the phenomenon and inherent methodological limitations. Here we review recent behavioral, brain imaging, and clinical research that has reshaped our understanding of mental imagery. Research supports the claim that visual mental imagery is a depictive internal representation that functions like a weak form of perception. Brain imaging work has demonstrated that neural representations of mental and perceptual images resemble one another as early as the primary visual cortex (V1). Activity patterns in V1 encode mental images and perceptual images via a common set of low-level depictive visual features. Recent translational and clinical research reveals the pivotal role that imagery plays in many mental disorders and suggests how clinicians can utilize imagery in treatment. PMID:26412097

Back schools for nonspecific low back pain: a systematic review within the framework of the Cochrane Collaboration Back Review Group.

PubMed

Heymans, M W; van Tulder, M W; Esmail, R; Bombardier, C; Koes, B W

2005-10-01

A systematic review within the Cochrane Collaboration Back Review Group. To assess the effectiveness of back schools for patients with nonspecific low back pain (LBP). Since the introduction of the Swedish back school in 1969, back schools have frequently been used for treating patients with LBP. However, the content of back schools has changed and appears to vary widely today. We searched the MEDLINE and EMBASE databases and the Cochrane Central Register of Controlled Trials to November 2004 for relevant trials reported in English, Dutch, French, or German. We also screened references from relevant reviews and included trials. Randomized controlled trials that reported on any type of back school for nonspecific LBP were included. Four reviewers, blinded to authors, institution, and journal, independently extracted the data and assessed the quality of the trials. We set the high-quality level, a priori, at a trial meeting six or more of 11 internal validity criteria. Because data were clinically and statistically too heterogeneous to perform a meta-analysis, we used a qualitative review (best evidence synthesis) to summarize the results. The evidence was classified into four levels (strong, moderate, limited, or no evidence), taking into account the methodologic quality of the studies. We also evaluated the clinical relevance of the studies. Nineteen randomized controlled trials (3,584 patients) were included in this updated review. Overall, the methodologic quality was low, with only six trials considered to be high-quality. It was not possible to perform relevant subgroup analyses for LBP with radiation versus LBP without radiation. The results indicate that there is moderate evidence suggesting that back schools have better short- and intermediate-term effects on pain and functional status than other treatments for patients with recurrent and chronic LBP. There is moderate evidence suggesting that back schools for chronic LBP in an occupational setting are more effective than other treatments and placebo or waiting list controls on pain, functional status, and return to work during short- and intermediate-term follow-up. In general, the clinical relevance of the studies was rated as insufficient. There is moderate evidence suggesting that back schools, in an occupational setting, reduce pain and improve function and return-to-work status, in the short- and intermediate-term, compared with exercises, manipulation, myofascial therapy, advice, placebo, or waiting list controls, for patients with chronic and recurrent LBP. However, future trials should improve methodologic quality and clinical relevance and evaluate the cost-effectiveness of back schools.

Design and methodology of a randomized clinical trial of home-based telemental health treatment for U.S. military personnel and veterans with depression.

PubMed

Luxton, David D; Pruitt, Larry D; O'Brien, Karen; Stanfill, Katherine; Jenkins-Guarnieri, Michael A; Johnson, Kristine; Wagner, Amy; Thomas, Elissa; Gahm, Gregory A

2014-05-01

Home-based telemental health (TMH) treatments have the potential to address current and future health needs of military service members, veterans, and their families, especially for those who live in rural or underserved areas. The use of home-based TMH treatments to address the behavioral health care needs of U.S. military healthcare beneficiaries is not presently considered standard of care in the Military Health System. The feasibility, safety, and clinical efficacy of home-based TMH treatments must be established before broad dissemination of home-based treatment programs can be implemented. This paper describes the design, methodology, and protocol of a clinical trial that compares in-office to home-based Behavioral Activation for Depression (BATD) treatment delivered via web-based video technology for service members and veterans with depression. This grant funded three-year randomized clinical trial is being conducted at the National Center for Telehealth and Technology at Joint-base Lewis-McChord and at the Portland VA Medical Center. Best practice recommendations regarding the implementation of in-home telehealth in the military setting as well as the cultural and contextual factors of providing in-home care to active duty and veteran military populations are also discussed. Published by Elsevier Inc.

Identifying complications of interventional procedures from UK routine healthcare databases: a systematic search for methods using clinical codes.

PubMed

Keltie, Kim; Cole, Helen; Arber, Mick; Patrick, Hannah; Powell, John; Campbell, Bruce; Sims, Andrew

2014-11-28

Several authors have developed and applied methods to routine data sets to identify the nature and rate of complications following interventional procedures. But, to date, there has been no systematic search for such methods. The objective of this article was to find, classify and appraise published methods, based on analysis of clinical codes, which used routine healthcare databases in a United Kingdom setting to identify complications resulting from interventional procedures. A literature search strategy was developed to identify published studies that referred, in the title or abstract, to the name or acronym of a known routine healthcare database and to complications from procedures or devices. The following data sources were searched in February and March 2013: Cochrane Methods Register, Conference Proceedings Citation Index - Science, Econlit, EMBASE, Health Management Information Consortium, Health Technology Assessment database, MathSciNet, MEDLINE, MEDLINE in-process, OAIster, OpenGrey, Science Citation Index Expanded and ScienceDirect. Of the eligible papers, those which reported methods using clinical coding were classified and summarised in tabular form using the following headings: routine healthcare database; medical speciality; method for identifying complications; length of follow-up; method of recording comorbidity. The benefits and limitations of each approach were assessed. From 3688 papers identified from the literature search, 44 reported the use of clinical codes to identify complications, from which four distinct methods were identified: 1) searching the index admission for specified clinical codes, 2) searching a sequence of admissions for specified clinical codes, 3) searching for specified clinical codes for complications from procedures and devices within the International Classification of Diseases 10th revision (ICD-10) coding scheme which is the methodology recommended by NHS Classification Service, and 4) conducting manual clinical review of diagnostic and procedure codes. The four distinct methods identifying complication from codified data offer great potential in generating new evidence on the quality and safety of new procedures using routine data. However the most robust method, using the methodology recommended by the NHS Classification Service, was the least frequently used, highlighting that much valuable observational data is being ignored.

Analysis of pressure distortion testing

NASA Technical Reports Server (NTRS)

Koch, K. E.; Rees, R. L.

1976-01-01

The development of a distortion methodology, method D, was documented, and its application to steady state and unsteady data was demonstrated. Three methodologies based upon DIDENT, a NASA-LeRC distortion methodology based upon the parallel compressor model, were investigated by applying them to a set of steady state data. The best formulation was then applied to an independent data set. The good correlation achieved with this data set showed that method E, one of the above methodologies, is a viable concept. Unsteady data were analyzed by using the method E methodology. This analysis pointed out that the method E sensitivities are functions of pressure defect level as well as corrected speed and pattern.

A methodological approach for assessing the uptake of core outcome sets using ClinicalTrials.gov: findings from a review of randomised controlled trials of rheumatoid arthritis.

PubMed

Kirkham, Jamie J; Clarke, Mike; Williamson, Paula R

2017-05-17

Objective  To assess the uptake of the rheumatoid arthritis core outcome set using a new assessment method of calculating uptake from data in clinical trial registry entries. Design  Review of randomised trials. Setting  ClinicalTrials.gov. Subjects  273 randomised trials of drug interventions for the treatment of rheumatoid arthritis and registered in ClinicalTrials.gov between 2002 and 2016. Full publications were identified for completed studies from information in the trial registry or from an internet search using Google and the citation database Web of Science. Main outcome measure  The percentage of trials reporting or planning to measure the rheumatoid arthritis core outcome set calculated from the information presented in the trial registry and compared with the percentage reporting the rheumatoid arthritis core outcome set in the resulting trial publications. Results  The full rheumatoid arthritis core outcome set was reported in 81% (116/143) of trials identified on the registry as completed (or terminated) for which results were found in either the published literature or the registry. For trials identified on the registry as completed (or terminated), using information only available in the registry gives an estimate for uptake of 77% (145/189). Conclusions  The uptake of the rheumatoid arthritis core outcome set in clinical trials has continued to increase over time. Using the information on outcomes listed for completed or terminated studies in a trial registry provides a reasonable estimate of the uptake of a core outcome set and is a more efficient and up-to-date approach than examining the outcomes in published trial reports. The method proposed may provide an efficient approach for an up-to-date assessment of the uptake of the 300 core outcome sets already published. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

The barriers to and benefits of conducting Q-sorts in the classroom.

PubMed

Killam, Laura; Timmermans, Katherine E; Raymond, June M

2013-11-01

To outline the barriers to and benefits of using Q methodology in a classroom. Q methodology has been established as a systematic way to measure subjectivity that is consistent with the naturalistic paradigm. While it is often confused with quantitative methods, it provides the qualitative researcher with powerful tools to investigate the diverse subjective experiences and perceptions of participants. Reflections in this paper stem from the experiences of the authors and are supported by literature. Barriers to conducting a Q-sort activity in the classroom are context dependent and may include limitations of the environment, time constraints as well as issues with comprehension. Despite these barriers, using a classroom for the activity can also enhance student learning, increase participation in research, clarify instructions, enrich study feedback and promote accessibility of the study population. With an understanding of potential pitfalls of using this methodology in the classroom setting, nurse researchers can develop strategies to reduce these barriers and enhance the quality of future research. Q-methodology is an alternate way of measuring the subjective views of individuals in a variety of settings such as clinical practice, research and educational institutions. Q-sorts may be used for research and/or classroom activities because the activity can promote discussion related to the content of a class. If using an activity like this one, educators and researchers need to be mindful of potential barriers to sorting in order to minimise them and maximise the potential of the activity.

Towards a rational antimicrobial testing policy in the laboratory.

PubMed

Banaji, N; Oommen, S

2011-01-01

Antimicrobial policy for prophylactic and therapeutic use of antimicrobials in a tertiary care setting has gained importance. A hospital's antimicrobial policy as laid down by its hospital infection control team needs to include inputs from the microbiology laboratory, besides the pharmacy and therapeutic committee. Therefore, it is of utmost importance that clinical microbiologists across India follow international guidelines and also take into account local settings, especially detection and presence of resistance enzymes. This article draws a framework for rational antimicrobial testing in our laboratories in tertiary care centers, from the Clinical and Laboratory Standards Institute guidelines. It does not address testing methodologies but suggests ways and means by which antimicrobial susceptibility reporting can be rendered meaningful not only to the treating physician but also to the resistance monitoring epidemiologist. It hopes to initiate some standardization in rational choice of antimicrobial testing in laboratories in the country pertaining to nonfastidious bacteria.

Understanding depression associated with chronic physical illness: a Q-methodology study in primary care

PubMed Central

Alderson, Sarah L; Foy, Robbie; House, Allan

2015-01-01

Background Detection of depression can be difficult in primary care, particularly when associated with chronic illness. Patient beliefs may affect detection and subsequent engagement with management. Q-methodology can help to identify viewpoints that are likely to influence either clinical practice or policy intervention. Aim To identify socially shared viewpoints of comorbid depression, and characterise key overlaps and discrepancies. Design and setting A Q-methodology study of patients registered with general practices or community clinics in Leeds, UK. Method Patients with coronary heart disease or diabetes and depression from three practices and community clinics were invited to participate. Participants ranked 57 statements about comorbid depression. Factor analyses were undertaken to identify independent accounts, and additional interview data were used to support interpretation. Results Thirty-one patients participated; 13 (42%) had current symptoms of depression. Five accounts towards comorbid depression were identified: overwhelmed resources; something medical or within me; a shameful weakness; part of who I am; and recovery-orientated. The main differences in attitudes related to the cause of depression and its relationship with the patient’s chronic illness, experience of shame, and whether medical interventions would help recovery. Conclusion There are groups of patients who do not perceive a relationship between their depression and chronic illness; they may not understand the intention behind policy initiatives to identify depression during chronic illness reviews. Tailoring detection strategies for depression to take account of different clusters of attitudes and beliefs could help improve identification and personalise management. PMID:26009535

Independent predictors of reliability between full time employee-dependent acquisition of functional outcomes compared to non-full time employee-dependent methodologies: a prospective single institutional study.

PubMed

Adogwa, Owoicho; Elsamadicy, Aladine A; Cheng, Joseph; Bagley, Carlos

2016-03-01

The prospective acquisition of reliable patient-reported outcomes (PROs) measures demonstrating the effectiveness of spine surgery, or lack thereof, remains a challenge. The aims of this study are to compare the reliability of functional outcomes metrics obtained using full time employee (FTE) vs. non-FTE-dependent methodologies and to determine the independent predictors of response reliability using non FTE-dependent methodologies. One hundred and nineteen adult patients (male: 65, female: 54) undergoing one- and two-level lumbar fusions at Duke University Medical Center were enrolled in this prospective study. Enrollment criteria included available demographic, clinical and baseline functional outcomes data. All patients were administered two similar sets of baseline questionnaires-(I) phone interviews (FTE-dependent) and (II) hardcopy in clinic (patient self-survey, non-FTE-dependent). All patients had at least a two-week washout period between phone interviews and in-clinic self-surveys to minimize effect of recall. Questionnaires included Oswestry disability index (ODI) and Visual Analog Back and Leg Pain Scale (VAS-BP/LP). Reliability was assessed by the degree to which patient responses to baseline questionnaires differed between both time points. About 26.89% had a history an anxiety disorder and 28.57% reported a history of depression. At least 97.47% of patients had a High School Diploma or GED, with 49.57% attaining a 4-year college degree or post-graduate degree. 29.94% reported full-time employment and 14.28% were on disability. There was a very high correlation between baseline PRO's data captured between FTE-dependent compared to non-FTE-dependent methodologies (r=0.89). In a multivariate logistic regression model, the absence of anxiety and depression, higher levels of education (college or greater) and full-time employment, were independently associated with high response reliability using non-FTE-dependent methodologies. Our study suggests that capturing health-related quality of life data using non-FTE-dependent methodologies is highly reliable and maybe a more cost-effective alternative. Well-educated patients who are employed full-time appear to be the most reliable.

An EAACI “European Survey on Adverse Systemic Reactions in Allergen Immunotherapy (EASSI)”: the methodology

PubMed Central

2014-01-01

At present, there is no European report on clinically relevant systemic reactions due to the regular use of allergen immunotherapy (AIT), administered either subcutaneously or sublingually (SCIT and SLIT, respectively) outside clinical trials. Using an electronic survey and a “harmonised terminology” according to MedDRA, we aimed to prospectively collect systemic adverse reactions due to AIT from real life clinical settings. Under the framework of the EAACI, a team of European specialists in AIT, pharmacovigilance, epidemiology and drugs regulation set up a web-based prospective pilot survey to be conducted in three European countries (France, Germany and Spain). A designated “national coordinator” was responsible for following ethics requirements relative to each country and to select at least 30 doctors per country. Patients were recruited the same day they received their first dose of either SCIT or SLIT. Patient inclusion criteria were: adults and children, with IgE mediated pollen, house dust mite, Alternaria, and/or animal dander respiratory allergies who will initiate AIT. A list of 31 symptoms terms were extracted from the MedDRA (Medical Dictionary for Regulatory Activities) dictionary to harmonize the reporting of all adverse systemic reactions in this survey. The SurveyMonkey® online instrument was used by participant doctors to submit information directly to a blinded central database. Three questionnaires were generated: i) the Doctor Questionnaire, ii) the Patient Questionnaire and iii) the Adverse Reaction Questionnaire. A handbook and a mistake report form were given to each doctor. In this paper, we describe the methodology followed. PMID:25075276

Experience sampling methodology in mental health research: new insights and technical developments

PubMed Central

Myin‐Germeys, Inez; Kasanova, Zuzana; Vaessen, Thomas; Vachon, Hugo; Kirtley, Olivia; Viechtbauer, Wolfgang; Reininghaus, Ulrich

2018-01-01

In the mental health field, there is a growing awareness that the study of psychiatric symptoms in the context of everyday life, using experience sampling methodology (ESM), may provide a powerful and necessary addition to more conventional research approaches. ESM, a structured self‐report diary technique, allows the investigation of experiences within, and in interaction with, the real‐world context. This paper provides an overview of how zooming in on the micro‐level of experience and behaviour using ESM adds new insights and additional perspectives to standard approaches. More specifically, it discusses how ESM: a) contributes to a deeper understanding of psychopathological phenomena, b) allows to capture variability over time, c) aids in identifying internal and situational determinants of variability in symptomatology, and d) enables a thorough investigation of the interaction between the person and his/her environment and of real‐life social interactions. Next to improving assessment of psychopathology and its underlying mechanisms, ESM contributes to advancing and changing clinical practice by allowing a more fine‐grained evaluation of treatment effects as well as by providing the opportunity for extending treatment beyond the clinical setting into real life with the development of ecological momentary interventions. Furthermore, this paper provides an overview of the technical details of setting up an ESM study in terms of design, questionnaire development and statistical approaches. Overall, although a number of considerations and challenges remain, ESM offers one of the best opportunities for personalized medicine in psychiatry, from both a research and a clinical perspective. PMID:29856567

Experience sampling methodology in mental health research: new insights and technical developments.

PubMed

Myin-Germeys, Inez; Kasanova, Zuzana; Vaessen, Thomas; Vachon, Hugo; Kirtley, Olivia; Viechtbauer, Wolfgang; Reininghaus, Ulrich

2018-06-01

In the mental health field, there is a growing awareness that the study of psychiatric symptoms in the context of everyday life, using experience sampling methodology (ESM), may provide a powerful and necessary addition to more conventional research approaches. ESM, a structured self-report diary technique, allows the investigation of experiences within, and in interaction with, the real-world context. This paper provides an overview of how zooming in on the micro-level of experience and behaviour using ESM adds new insights and additional perspectives to standard approaches. More specifically, it discusses how ESM: a) contributes to a deeper understanding of psychopathological phenomena, b) allows to capture variability over time, c) aids in identifying internal and situational determinants of variability in symptomatology, and d) enables a thorough investigation of the interaction between the person and his/her environment and of real-life social interactions. Next to improving assessment of psychopathology and its underlying mechanisms, ESM contributes to advancing and changing clinical practice by allowing a more fine-grained evaluation of treatment effects as well as by providing the opportunity for extending treatment beyond the clinical setting into real life with the development of ecological momentary interventions. Furthermore, this paper provides an overview of the technical details of setting up an ESM study in terms of design, questionnaire development and statistical approaches. Overall, although a number of considerations and challenges remain, ESM offers one of the best opportunities for personalized medicine in psychiatry, from both a research and a clinical perspective. © 2018 World Psychiatric Association.

Mobile Devices for the Remote Acquisition of Physiological and Behavioral Biomarkers in Psychiatric Clinical Research

PubMed Central

Adams, Zachary; McClure, Erin A.; Gray, Kevin M.; Danielson, Carla Kmett; Treiber, Frank A.; Ruggiero, Kenneth J.

2016-01-01

Psychiatric disorders are linked to a variety of biological, psychological, and contextual causes and consequences. Laboratory studies have elucidated the importance of several key physiological and behavioral biomarkers in the study of psychiatric disorders, but much less is known about the role of these biomarkers in naturalistic settings. These gaps are largely driven by methodological barriers to assessing biomarker data rapidly, reliably, and frequently outside the clinic or laboratory. Mobile health (mHealth) tools offer new opportunities to study relevant biomarkers in concert with other types of data (e.g., self-reports, global positioning system data). This review provides an overview on the state of this emerging field and describes examples from the literature where mHealth tools have been used to measure a wide array of biomarkers in the context of psychiatric functioning (e.g., psychological stress, anxiety, autism, substance use). We also outline advantages and special considerations for incorporating mHealth tools for remote biomarker measurement into studies of psychiatric illness and treatment and identify several specific opportunities for expanding this promising methodology. Integrating mHealth tools into this area may dramatically improve psychiatric science and facilitate highly personalized clinical care of psychiatric disorders. PMID:27814455

Computational assessment of hemodynamics-based diagnostic tools using a database of virtual subjects: Application to three case studies.

PubMed

Willemet, Marie; Vennin, Samuel; Alastruey, Jordi

2016-12-08

Many physiological indexes and algorithms based on pulse wave analysis have been suggested in order to better assess cardiovascular function. Because these tools are often computed from in-vivo hemodynamic measurements, their validation is time-consuming, challenging, and biased by measurement errors. Recently, a new methodology has been suggested to assess theoretically these computed tools: a database of virtual subjects generated using numerical 1D-0D modeling of arterial hemodynamics. The generated set of simulations encloses a wide selection of healthy cases that could be encountered in a clinical study. We applied this new methodology to three different case studies that demonstrate the potential of our new tool, and illustrated each of them with a clinically relevant example: (i) we assessed the accuracy of indexes estimating pulse wave velocity; (ii) we validated and refined an algorithm that computes central blood pressure; and (iii) we investigated theoretical mechanisms behind the augmentation index. Our database of virtual subjects is a new tool to assist the clinician: it provides insight into the physical mechanisms underlying the correlations observed in clinical practice. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Formalize clinical processes into electronic health information systems: Modelling a screening service for diabetic retinopathy.

PubMed

Eguzkiza, Aitor; Trigo, Jesús Daniel; Martínez-Espronceda, Miguel; Serrano, Luis; Andonegui, José

2015-08-01

Most healthcare services use information and communication technologies to reduce and redistribute the workload associated with follow-up of chronic conditions. However, the lack of normalization of the information handled in and exchanged between such services hinders the scalability and extendibility. The use of medical standards for modelling and exchanging information, especially dual-model based approaches, can enhance the features of screening services. Hence, the approach of this paper is twofold. First, this article presents a generic methodology to model patient-centered clinical processes. Second, a proof of concept of the proposed methodology was conducted within the diabetic retinopathy (DR) screening service of the Health Service of Navarre (Spain) in compliance with a specific dual-model norm (openEHR). As a result, a set of elements required for deploying a model-driven DR screening service has been established, namely: clinical concepts, archetypes, termsets, templates, guideline definition rules, and user interface definitions. This model fosters reusability, because those elements are available to be downloaded and integrated in any healthcare service, and interoperability, since from then on such services can share information seamlessly. Copyright © 2015 Elsevier Inc. All rights reserved.

Phenotype-loci associations in networks of patients with rare disorders: application to assist in the diagnosis of novel clinical cases.

PubMed

Bueno, Anibal; Rodríguez-López, Rocío; Reyes-Palomares, Armando; Rojano, Elena; Corpas, Manuel; Nevado, Julián; Lapunzina, Pablo; Sánchez-Jiménez, Francisca; Ranea, Juan A G

2018-06-26

Copy number variations (CNVs) are genomic structural variations (deletions, duplications, or translocations) that represent the 4.8-9.5% of human genome variation in healthy individuals. In some cases, CNVs can also lead to disease, being the etiology of many known rare genetic/genomic disorders. Despite the last advances in genomic sequencing and diagnosis, the pathological effects of many rare genetic variations remain unresolved, largely due to the low number of patients available for these cases, making it difficult to identify consistent patterns of genotype-phenotype relationships. We aimed to improve the identification of statistically consistent genotype-phenotype relationships by integrating all the genetic and clinical data of thousands of patients with rare genomic disorders (obtained from the DECIPHER database) into a phenotype-patient-genotype tripartite network. Then we assessed how our network approach could help in the characterization and diagnosis of novel cases in clinical genetics. The systematic approach implemented in this work is able to better define the relationships between phenotypes and specific loci, by exploiting large-scale association networks of phenotypes and genotypes in thousands of rare disease patients. The application of the described methodology facilitated the diagnosis of novel clinical cases, ranking phenotypes by locus specificity and reporting putative new clinical features that may suggest additional clinical follow-ups. In this work, the proof of concept developed over a set of novel clinical cases demonstrates that this network-based methodology might help improve the precision of patient clinical records and the characterization of rare syndromes.

The Promise of Neurotechnology in Clinical Translational Science.

PubMed

White, Susan W; Richey, John A; Gracanin, Denis; Bell, Martha Ann; LaConte, Stephen; Coffman, Marika; Trubanova, Andrea; Kim, Inyoung

2015-09-01

Neurotechnology is broadly defined as a set of devices used to understand neural processes and applications that can potentially facilitate the brain's ability to repair itself. In the past decade, an increasingly explicit understanding of basic biological mechanisms of brain-related illnesses has produced applications that allow a direct yet noninvasive method to index and manipulate the functioning of the human nervous system. Clinical scientists are poised to apply this technology to assess, treat, and better understand complex socioemotional processes that underlie many forms of psychopathology. In this review, we describe the potential benefits and hurdles, both technical and methodological, of neurotechnology in the context of clinical dysfunction. We also offer a framework for developing and evaluating neurotechnologies that is intended to expedite progress at the nexus of clinical science and neural interface designs by providing a comprehensive vocabulary to describe the necessary features of neurotechnology in the clinic.

The Promise of Neurotechnology in Clinical Translational Science

PubMed Central

White, Susan W.; Richey, John A.; Gracanin, Denis; Bell, Martha Ann; LaConte, Stephen; Coffman, Marika; Trubanova, Andrea; Kim, Inyoung

2014-01-01

Neurotechnology is broadly defined as a set of devices used to understand neural processes and applications that can potentially facilitate the brain’s ability to repair itself. In the past decade, an increasingly explicit understanding of basic biological mechanisms of brain-related illnesses has produced applications that allow a direct yet noninvasive method to index and manipulate the functioning of the human nervous system. Clinical scientists are poised to apply this technology to assess, treat, and better understand complex socioemotional processes that underlie many forms of psychopathology. In this review, we describe the potential benefits and hurdles, both technical and methodological, of neurotechnology in the context of clinical dysfunction. We also offer a framework for developing and evaluating neurotechnologies that is intended to expedite progress at the nexus of clinical science and neural interface designs by providing a comprehensive vocabulary to describe the necessary features of neurotechnology in the clinic. PMID:26504676

Methodology for Computational Fluid Dynamic Validation for Medical Use: Application to Intracranial Aneurysm.

PubMed

Paliwal, Nikhil; Damiano, Robert J; Varble, Nicole A; Tutino, Vincent M; Dou, Zhongwang; Siddiqui, Adnan H; Meng, Hui

2017-12-01

Computational fluid dynamics (CFD) is a promising tool to aid in clinical diagnoses of cardiovascular diseases. However, it uses assumptions that simplify the complexities of the real cardiovascular flow. Due to high-stakes in the clinical setting, it is critical to calculate the effect of these assumptions in the CFD simulation results. However, existing CFD validation approaches do not quantify error in the simulation results due to the CFD solver's modeling assumptions. Instead, they directly compare CFD simulation results against validation data. Thus, to quantify the accuracy of a CFD solver, we developed a validation methodology that calculates the CFD model error (arising from modeling assumptions). Our methodology identifies independent error sources in CFD and validation experiments, and calculates the model error by parsing out other sources of error inherent in simulation and experiments. To demonstrate the method, we simulated the flow field of a patient-specific intracranial aneurysm (IA) in the commercial CFD software star-ccm+. Particle image velocimetry (PIV) provided validation datasets for the flow field on two orthogonal planes. The average model error in the star-ccm+ solver was 5.63 ± 5.49% along the intersecting validation line of the orthogonal planes. Furthermore, we demonstrated that our validation method is superior to existing validation approaches by applying three representative existing validation techniques to our CFD and experimental dataset, and comparing the validation results. Our validation methodology offers a streamlined workflow to extract the "true" accuracy of a CFD solver.

Using an action research process in pharmacy practice research--a cooperative project between university and internship pharmacies.

PubMed

Sørensen, Ellen Westh; Haugbølle, Lotte Stig

2008-12-01

Action research (AR) is a common research-based methodology useful for development and organizational changes in health care when participant involvement is key. However, AR is not widely used for research in the development of pharmaceutical care services in pharmacy practice. To disseminate the experience from using AR methodology to develop cognitive services in pharmacies by describing how the AR process was conducted in a specific study, and to describe the outcome for participants. The study was conducted over a 3-year period and run by a steering group of researchers, pharmacy students, and preceptors. The study design was based on AR methodology. The following data production methods were used to describe and evaluate the AR model: documentary analysis, qualitative interviews, and questionnaires. Experiences from using AR methodology and the outcome for participants are described. A set of principles was followed while the study, called the Pharmacy-University study, was being conducted. These principles are considered useful for designing future AR studies. Outcome for participating pharmacies was registered for staff-oriented and patient-oriented activities. Outcome for students was practice as project leaders and enhancement of clinical pharmacy-based skills. Outcome for researchers and the steering group conducting the study was in-depth knowledge of the status of pharmacies in giving advice to patient groups, and effective learning methods for students. Developing and implementing cognitive pharmaceutical services (CPS) involves wide-reaching changes that require the willingness of pharmacy and staff as well as external partners. The use of AR methodology creates a platform that supports raising the awareness and the possible inclusion of these partners. During this study, a set of tools was developed for use in implementing CPS as part of AR.

A scoping review of adult chronic kidney disease clinical pathways for primary care.

PubMed

Elliott, Meghan J; Gil, Sarah; Hemmelgarn, Brenda R; Manns, Braden J; Tonelli, Marcello; Jun, Min; Donald, Maoliosa

2017-05-01

Chronic kidney disease (CKD) affects ∼10% of the adult population. The majority of patients with CKD are managed by primary care physicians, and despite the availability of effective treatment options, the use of evidence-based interventions for CKD in this setting remains suboptimal. Clinical pathways have been identified as effective tools to guide primary care physicians in providing evidence-based care. We aimed to describe the availability, characteristics and credibility of clinical pathways for adult CKD using a scoping review methodology. We searched Medline, Embase, CINAHL and targeted Internet sites from inception to 31 October 2014 to identify studies and resources that identified adult CKD clinical pathways for primary care settings. Study selection and data extraction were independently performed by two reviewers. From 487 citations, 41 items were eligible for review: 7 published articles and 34 grey literature resources published between 2001 and 2014. Of the 41 clinical pathways, 32, 24 and 22% were from the UK, USA and Canada, respectively. The majority (66%, n = 31) of clinical pathways were static in nature (did not have an online interactive feature). The majority (76%) of articles/resources reported using one or more clinical practice guidelines as a resource to guide the clinical pathway content. Few articles described a dissemination and evaluation plan for the clinical pathway, but most reported the targeted end-users. Our scoping review synthesized available literature on CKD clinical pathways in the primary care setting. We found that existing clinical pathways are diverse in their design, content and implementation. These results can be used by researchers developing or testing new or existing clinical pathways and by practitioners and health system stakeholders who aim to implement CKD clinical pathways in clinical practice. © The Author 2016. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.

Research design considerations for single-dose analgesic clinical trials in acute pain: IMMPACT recommendations.

PubMed

Cooper, Stephen A; Desjardins, Paul J; Turk, Dennis C; Dworkin, Robert H; Katz, Nathaniel P; Kehlet, Henrik; Ballantyne, Jane C; Burke, Laurie B; Carragee, Eugene; Cowan, Penney; Croll, Scott; Dionne, Raymond A; Farrar, John T; Gilron, Ian; Gordon, Debra B; Iyengar, Smriti; Jay, Gary W; Kalso, Eija A; Kerns, Robert D; McDermott, Michael P; Raja, Srinivasa N; Rappaport, Bob A; Rauschkolb, Christine; Royal, Mike A; Segerdahl, Märta; Stauffer, Joseph W; Todd, Knox H; Vanhove, Geertrui F; Wallace, Mark S; West, Christine; White, Richard E; Wu, Christopher

2016-02-01

This article summarizes the results of a meeting convened by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) on key considerations and best practices governing the design of acute pain clinical trials. We discuss the role of early phase clinical trials, including pharmacokinetic-pharmacodynamic (PK-PD) trials, and the value of including both placebo and active standards of comparison in acute pain trials. This article focuses on single-dose and short-duration trials with emphasis on the perioperative and study design factors that influence assay sensitivity. Recommendations are presented on assessment measures, study designs, and operational factors. Although most of the methodological advances have come from studies of postoperative pain after dental impaction, bunionectomy, and other surgeries, the design considerations discussed are applicable to many other acute pain studies conducted in different settings.

MO-A-BRB-01: TG191: Clinical Use of Luminescent Dosimeters

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kry, S.

This presentation will highlight the upcoming TG-191 report: Clinical Use of Luminescent Dosimeters. Luminescent dosimetry based on TLD and OSLD is a practical, accurate, and precise technique for point dosimetry in medical physics applications. The charges of Task Group 191 were to detail the methodologies for practical and optimal luminescent dosimetry in a clinical setting. This includes (1) To review the variety of TLD/OSL materials available, including features and limitations of each. (2) To outline the optimal steps to achieve accurate and precise dosimetry with luminescent detectors and to evaluate the uncertainty induced when less rigorous procedures are used. (3)more » To develop consensus guidelines on the optimal use of luminescent dosimeters for clinical practice. (4) To develop guidelines for special medically relevant uses of TLDs/OSLs (e.g., mixed field i.e. photon/neutron dosimetry, particle beam dosimetry, skin dosimetry). While this report provides general guidelines for arbitrary TLD and OSLD processes, the report, and therefore this presentation, provide specific guidance for TLD-100 (LiF:Ti,Mg) and nanoDot (Al2O3:C) dosimeters because of their prevalence in clinical practice. Learning Objectives: Understand the available dosimetry systems, and basic theory of their operation Understand the range of dose determination methodologies and the uncertainties associated with them Become familiar with special considerations for TLD/OSLD relevant for special clinical situations Learn recommended commissioning and QA procedures for these dosimetry systems.« less

MO-A-BRB-00: TG191: Clinical Use of Luminescent Dosimeters

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

This presentation will highlight the upcoming TG-191 report: Clinical Use of Luminescent Dosimeters. Luminescent dosimetry based on TLD and OSLD is a practical, accurate, and precise technique for point dosimetry in medical physics applications. The charges of Task Group 191 were to detail the methodologies for practical and optimal luminescent dosimetry in a clinical setting. This includes (1) To review the variety of TLD/OSL materials available, including features and limitations of each. (2) To outline the optimal steps to achieve accurate and precise dosimetry with luminescent detectors and to evaluate the uncertainty induced when less rigorous procedures are used. (3)more » To develop consensus guidelines on the optimal use of luminescent dosimeters for clinical practice. (4) To develop guidelines for special medically relevant uses of TLDs/OSLs (e.g., mixed field i.e. photon/neutron dosimetry, particle beam dosimetry, skin dosimetry). While this report provides general guidelines for arbitrary TLD and OSLD processes, the report, and therefore this presentation, provide specific guidance for TLD-100 (LiF:Ti,Mg) and nanoDot (Al2O3:C) dosimeters because of their prevalence in clinical practice. Learning Objectives: Understand the available dosimetry systems, and basic theory of their operation Understand the range of dose determination methodologies and the uncertainties associated with them Become familiar with special considerations for TLD/OSLD relevant for special clinical situations Learn recommended commissioning and QA procedures for these dosimetry systems.« less

What if pediatric residents could bill for their outpatient services?

PubMed

Ng, M; Lawless, S T

2001-10-01

We prospectively studied the potential of billing and coding practices of pediatric residents in outpatient clinics and extrapolated our results to assess the financial implications of billing inaccuracies. Using Medicare as a common measure of "currency," we also used the relative value unit (RVU) and ambulatory payment class methodologies as means of assessing the productivity and financial value of resident-staffed pediatric clinics. Residents were asked to submit voluntarily shadow billing forms and documentation of outpatient clinic visits. Documentation of work was assessed by a blinded reviewer, and current procedure terminology evaluation and management codes were assigned. Comparisons between resident codes and calculated codes were made. Financial implications of physician productivity were calculated in terms of dollar amounts and RVUs. Resource intensity was measured using the ambulatory payment class methodology. A total of 344 charts were reviewed. Coding agreement for health maintenance visits was 86%, whereas agreement for acute care visits was 38%. Eighty-three percent of coding disagreement in the latter group was resulting from undercoding by residents. Errors accounted for a 4.79% difference in potential reimbursement for all visit types and a 19.10% difference for acute care visits. No significant differences in shadow billing discrepancies were found between different levels of training. Residents were predicted to generate $67 230, $87 593, and $96 072 in Medicare revenue in the outpatient clinic setting during each successive year of training. On average, residents generated 1.17 +/- 0.01 and 0.81 +/- 0.02 work RVUs for each health maintenance visit and office visit, respectively. Annual productivity from outpatient clinic settings was estimated at 548, 735, and 893 work RVUs in the postgraduate levels 1, 2, and 3, respectively. When pediatric residents are not trained adequately in proper coding practices, the potential for billing discrepancies is high and potential reimbursement differences may be substantial. Discussion of financial issues should be considered in curriculum development.

A hierarchical clustering methodology for the estimation of toxicity.

PubMed

Martin, Todd M; Harten, Paul; Venkatapathy, Raghuraman; Das, Shashikala; Young, Douglas M

2008-01-01

ABSTRACT A quantitative structure-activity relationship (QSAR) methodology based on hierarchical clustering was developed to predict toxicological endpoints. This methodology utilizes Ward's method to divide a training set into a series of structurally similar clusters. The structural similarity is defined in terms of 2-D physicochemical descriptors (such as connectivity and E-state indices). A genetic algorithm-based technique is used to generate statistically valid QSAR models for each cluster (using the pool of descriptors described above). The toxicity for a given query compound is estimated using the weighted average of the predictions from the closest cluster from each step in the hierarchical clustering assuming that the compound is within the domain of applicability of the cluster. The hierarchical clustering methodology was tested using a Tetrahymena pyriformis acute toxicity data set containing 644 chemicals in the training set and with two prediction sets containing 339 and 110 chemicals. The results from the hierarchical clustering methodology were compared to the results from several different QSAR methodologies.

Estimates of Dietary Sodium Consumption in Patients With Chronic Heart Failure.

PubMed

Colin-Ramirez, Eloisa; Arcand, JoAnne; Ezekowitz, Justin A

2015-12-01

Estimating dietary sodium intake is a key component of dietary assessment in the clinical setting of HF to effectively implement appropriate dietary interventions for sodium reduction and monitor adherence to the dietary treatment. In a research setting, assessment of sodium intake is crucial to an essential methodology to evaluate outcomes after a dietary or behavioral intervention. Current available sodium intake assessment methods include 24-hour urine collection, spot urine collections, multiple day food records, food recalls, and food frequency questionnaires. However, these methods have inherent limitations that make assessment of sodium intake challenging, and the utility of traditional methods may be questionable for estimating sodium intake in patients with HF. Thus, there are remaining questions about how to best assess dietary sodium intake in this patient population, and there is a need to identify a reliable method to assess and monitor sodium intake in the research and clinical setting of HF. This paper provides a comprehensive review of the current methods for sodium intake assessment, addresses the challenges for its accurate evaluation, and highlights the relevance of applying the highest-quality measurement methods in the research setting to minimize the risk of biased data. Copyright © 2015 Elsevier Inc. All rights reserved.

Pain assessment for people with dementia: a systematic review of systematic reviews of pain assessment tools.

PubMed

Lichtner, Valentina; Dowding, Dawn; Esterhuizen, Philip; Closs, S José; Long, Andrew F; Corbett, Anne; Briggs, Michelle

2014-12-17

There is evidence of under-detection and poor management of pain in patients with dementia, in both long-term and acute care. Accurate assessment of pain in people with dementia is challenging and pain assessment tools have received considerable attention over the years, with an increasing number of tools made available. Systematic reviews on the evidence of their validity and utility mostly compare different sets of tools. This review of systematic reviews analyses and summarises evidence concerning the psychometric properties and clinical utility of pain assessment tools in adults with dementia or cognitive impairment. We searched for systematic reviews of pain assessment tools providing evidence of reliability, validity and clinical utility. Two reviewers independently assessed each review and extracted data from them, with a third reviewer mediating when consensus was not reached. Analysis of the data was carried out collaboratively. The reviews were synthesised using a narrative synthesis approach. We retrieved 441 potentially eligible reviews, 23 met the criteria for inclusion and 8 provided data for extraction. Each review evaluated between 8 and 13 tools, in aggregate providing evidence on a total of 28 tools. The quality of the reviews varied and the reporting often lacked sufficient methodological detail for quality assessment. The 28 tools appear to have been studied in a variety of settings and with varied types of patients. The reviews identified several methodological limitations across the original studies. The lack of a 'gold standard' significantly hinders the evaluation of tools' validity. Most importantly, the samples were small providing limited evidence for use of any of the tools across settings or populations. There are a considerable number of pain assessment tools available for use with the elderly cognitive impaired population. However there is limited evidence about their reliability, validity and clinical utility. On the basis of this review no one tool can be recommended given the existing evidence.

Methodological quality of randomized controlled trials of spinal manipulation and mobilization in tension-type headache, migraine, and cervicogenic headache.

PubMed

Fernández-de-las-Peñas, César; Alonso-Blanco, Cristina; San-Roman, Jesús; Miangolarra-Page, Juan C

2006-03-01

Literature review of quality of clinical trials. To determine the methodological quality of published randomized controlled trials that used spinal manipulation and/or mobilization to treat patients with tension-type headache (TTH), cervicogenic headache (CeH), and migraine (M) in the last decade. TTH, CeH, and M are the most prevalent types of headaches seen in adults. Individuals who have headaches frequently use physical therapy, manual therapy, or chiropractic care. Randomized controlled trials are considered an optimal method with which to assess the efficacy of any intervention. Computerized literature searches were performed in MEDLINE, EMBASE, COCHRANE, AMED, MANTIS, CINHAL, and PEDro databases. Randomized controlled trials in which spinal manipulation and/or mobilization had been used for TTH, CeH, and M published in a peer-reviewed journal as full text, and with at least 1 clinically relevant outcome measure (ie, headache intensity, duration, or frequency) were reviewed. The methodological quality of the studies was assessed independently by 2 reviewers using a set of predefined criteria. Only 8 studies met all the inclusion criteria. One clinical trial evaluated spinal manipulation and mobilization together, and the remaining 7 assessed spinal manipulative therapy. No controlled trials analyzing exclusively the effects of spinal mobilization were found. Methodological scores ranged from 35 to 56 points out of a theoretical maximum of 100 points, indicating an overall poor methodology of the studies. Only 2 studies obtained a high-quality score (greater than 50 points). No significant differences in quality scores were found based on the type of headache investigated. Methodological quality was not associated with the year of publication (before 2000, or later) nor with the results (positive, neutral, negative) reported in the studies. The most common flaws were a small sample size, the absence of a placebo control group, lack of blinded patients, and no description of the manipulative procedure. There are few published randomized controlled trials analyzing the effectiveness of spinal manipulation and/or mobilization for TTH, CeH, and M in the last decade. In addition, the methodological quality of these papers is typically low. Clearly, there is a need for high-quality randomized controlled trials assessing the effectiveness of these interventions in these headache disorders.

How equity is addressed in clinical practice guidelines: a content analysis

PubMed Central

Shi, Chunhu; Tian, Jinhui; Wang, Quan; Petkovic, Jennifer; Ren, Dan; Yang, Kehu; Yang, Yang

2014-01-01

Objectives Considering equity into guidelines presents methodological challenges. This study aims to qualitatively synthesise the methods for incorporating equity in clinical practice guidelines (CPGs). Setting Content analysis of methodological publications. Eligibility criteria for selecting studies Methodological publications were included if they provided checklists/frameworks on when, how and to what extent equity should be incorporated in CPGs. Data sources We electronically searched MEDLINE, retrieved references, and browsed guideline development organisation websites from inception to January 2013. After study selection by two authors, general characteristics and checklists items/framework components from included studies were extracted. Based on the questions or items from checklists/frameworks (unit of analysis), content analysis was conducted to identify themes and questions/items were grouped into these themes. Primary outcomes The primary outcomes were methodological themes and processes on how to address equity issues in guideline development. Results 8 studies with 10 publications were included from 3405 citations. In total, a list of 87 questions/items was generated from 17 checklists/frameworks. After content analysis, questions were grouped into eight themes (‘scoping questions’, ‘searching relevant evidence’, ‘appraising evidence and recommendations’, ‘formulating recommendations’, ‘monitoring implementation’, ‘providing a flow chart to include equity in CPGs’, and ‘others: reporting of guidelines and comments from stakeholders’ for CPG developers and ‘assessing the quality of CPGs’ for CPG users). Four included studies covered more than five of these themes. We also summarised the process of guideline development based on the themes mentioned above. Conclusions For disadvantaged population-specific CPGs, eight important methodological issues identified in this review should be considered when including equity in CPGs under the guidance of a scientific guideline development manual. PMID:25479795

Development and Application of a Clinical Microsystem Simulation Methodology for Human Factors-Based Research of Alarm Fatigue.

PubMed

Kobayashi, Leo; Gosbee, John W; Merck, Derek L

2017-07-01

(1) To develop a clinical microsystem simulation methodology for alarm fatigue research with a human factors engineering (HFE) assessment framework and (2) to explore its application to the comparative examination of different approaches to patient monitoring and provider notification. Problems with the design, implementation, and real-world use of patient monitoring systems result in alarm fatigue. A multidisciplinary team is developing an open-source tool kit to promote bedside informatics research and mitigate alarm fatigue. Simulation, HFE, and computer science experts created a novel simulation methodology to study alarm fatigue. Featuring multiple interconnected simulated patient scenarios with scripted timeline, "distractor" patient care tasks, and triggered true and false alarms, the methodology incorporated objective metrics to assess provider and system performance. Developed materials were implemented during institutional review board-approved study sessions that assessed and compared an experimental multiparametric alerting system with a standard monitor telemetry system for subject response, use characteristics, and end-user feedback. A four-patient simulation setup featuring objective metrics for participant task-related performance and response to alarms was developed along with accompanying structured HFE assessment (questionnaire and interview) for monitor systems use testing. Two pilot and four study sessions with individual nurse subjects elicited true alarm and false alarm responses (including diversion from assigned tasks) as well as nonresponses to true alarms. In-simulation observation and subject questionnaires were used to test the experimental system's approach to suppressing false alarms and alerting providers. A novel investigative methodology applied simulation and HFE techniques to replicate and study alarm fatigue in controlled settings for systems assessment and experimental research purposes.

What do eye movements tell us about patients with neurological disorders? — An introduction to saccade recording in the clinical setting —

PubMed Central

TERAO, Yasuo; FUKUDA, Hideki; HIKOSAKA, Okihide

2017-01-01

Non-invasive and readily implemented in the clinical setting, eye movement studies have been conducted extensively not only in healthy human subjects but also in patients with neurological disorders. The purpose of saccade studies is to “read out” the pathophysiology underlying neurological disorders from the saccade records, referring to known primate physiology. In the current review, we provide an overview of studies in which we attempted to elucidate the patterns of saccade abnormalities in over 250 patients with neurological disorders, including cerebellar ataxia and brainstem pathology due to neurodegenerative disorders, and what they tell about the pathophysiology of patients with neurological disorders. We also discuss how interventions, such as deep brain stimulation, affect saccade performance and provide further insights into the workings of the oculomotor system in humans. Finally, we argue that it is important to understand the functional significance and behavioral correlate of saccade abnormalities in daily life, which could require eye tracking methodologies to be performed in settings similar to daily life. PMID:29225306

Balancing power: A grounded theory study on partnership of academic service institutes

PubMed Central

HESHMATI NABAVI, FATEMEH; VANAKI, ZOHREH; MOHAMMADI, EESA; YAZDANI, SHAHRAM

2017-01-01

Introduction: Governments and professional organizations have called for new partnerships between health care providers and academics to improve clinical education for the benefit of both students and patients. To develop a substantive grounded theory on the process of forming academic-service partnerships in implementing clinical education, from the perspective of academic and clinical nursing staff members and managers working in Iranian settings. Methods: The participants included 15 hospital nurses, nurse managers, nurse educators, and educational managers from two central universities and clinical settings from 2009 to 2012. Data were collected through 30 in-depth, semi-structure interviews with the individual participants and then analyzed using the methodology of Strauss and Corbin's grounded theory. Results: Utilizing “balancing power” as the core variable enabled us to integrate the concepts concerning the partnership processes between clinical and educational institutes. Three distinct and significant categories emerged to explain the process of partnership: 1) divergence, 2) conflict between educational and caring functions, and 3) creation of balance between educational and caring functions. Conclusions: In implementing clinical education, partnerships have been formed within a challenging context in Iran. Conflict between clinical and educational functions was the main concern of both sides of the partnership in forming a collaborative relationship, with our findings emphasizing the importance of nursing educators' role in the establishment of partnership programs. PMID:28761886

Identification of design features to enhance utilization and acceptance of systems for Internet-based decision support at the point of care.

PubMed

Gadd, C S; Baskaran, P; Lobach, D F

1998-01-01

Extensive utilization of point-of-care decision support systems will be largely dependent on the development of user interaction capabilities that make them effective clinical tools in patient care settings. This research identified critical design features of point-of-care decision support systems that are preferred by physicians, through a multi-method formative evaluation of an evolving prototype of an Internet-based clinical decision support system. Clinicians used four versions of the system--each highlighting a different functionality. Surveys and qualitative evaluation methodologies assessed clinicians' perceptions regarding system usability and usefulness. Our analyses identified features that improve perceived usability, such as telegraphic representations of guideline-related information, facile navigation, and a forgiving, flexible interface. Users also preferred features that enhance usefulness and motivate use, such as an encounter documentation tool and the availability of physician instruction and patient education materials. In addition to identifying design features that are relevant to efforts to develop clinical systems for point-of-care decision support, this study demonstrates the value of combining quantitative and qualitative methods of formative evaluation with an iterative system development strategy to implement new information technology in complex clinical settings.

Clinical, classroom, or personal education: attitudes about health literacy.

PubMed

Logan, Robert A

2007-04-01

This study explores how diverse attitudes about health literacy are assessed by medical librarians and other health care professionals. An online survey of thirty-six items was conducted using Q methodology in two phases in spring 2005 and winter 2006. Respondents (n = 51) were nonrandomly self-selected from a convenience sample of members of the Medical Library Association and a group of environmental health consultants to the National Library of Medicine. Three factors were identified. Factor 1 is optimistic and supportive of health literacy's transformative sociocultural and professional potential, if clinical settings become a launching point for health literacy activities. Factor 2 is less optimistic about health literacy's potential to improve clinical or patient outcomes and prefers to focus health literacy initiatives on classroom education settings. Factor 3 supports improving the nation's health literacy but tends to support health literacy initiatives when people privately interact with health information materials. Each factor's attitudes about the appropriate educational venue to initiate health literacy activities are different and somewhat mutually exclusive. This suggests that health literacy is seen through different perceptual frameworks that represent a possible source of professional disagreement.

3D motion and strain estimation of the heart: initial clinical findings

NASA Astrophysics Data System (ADS)

Barbosa, Daniel; Hristova, Krassimira; Loeckx, Dirk; Rademakers, Frank; Claus, Piet; D'hooge, Jan

2010-03-01

The quantitative assessment of regional myocardial function remains an important goal in clinical cardiology. As such, tissue Doppler imaging and speckle tracking based methods have been introduced to estimate local myocardial strain. Recently, volumetric ultrasound has become more readily available, allowing therefore the 3D estimation of motion and myocardial deformation. Our lab has previously presented a method based on spatio-temporal elastic registration of ultrasound volumes to estimate myocardial motion and deformation in 3D, overcoming the spatial limitations of the existing methods. This method was optimized on simulated data sets in previous work and is currently tested in a clinical setting. In this manuscript, 10 healthy volunteers, 10 patient with myocardial infarction and 10 patients with arterial hypertension were included. The cardiac strain values extracted with the proposed method were compared with the ones estimated with 1D tissue Doppler imaging and 2D speckle tracking in all patient groups. Although the absolute values of the 3D strain components assessed by this new methodology were not identical to the reference methods, the relationship between the different patient groups was similar.

gSRT-Soft: a generic software application and some methodological guidelines to investigate implicit learning through visual-motor sequential tasks.

PubMed

Chambaron, Stéphanie; Ginhac, Dominique; Perruchet, Pierre

2008-05-01

Serial reaction time tasks and, more generally, the visual-motor sequential paradigms are increasingly popular tools in a variety of research domains, from studies on implicit learning in laboratory contexts to the assessment of residual learning capabilities of patients in clinical settings. A consequence of this success, however, is the increased variability in paradigms and the difficulty inherent in respecting the methodological principles that two decades of experimental investigations have made more and more stringent. The purpose of the present article is to address those problems. We present a user-friendly application that simplifies running classical experiments, but is flexible enough to permit a broad range of nonstandard manipulations for more specific objectives. Basic methodological guidelines are also provided, as are suggestions for using the software to explore unconventional directions of research. The most recent version of gSRT-Soft may be obtained for free by contacting the authors.

Recent advances in computational methodology for simulation of mechanical circulatory assist devices

PubMed Central

Marsden, Alison L.; Bazilevs, Yuri; Long, Christopher C.; Behr, Marek

2014-01-01

Ventricular assist devices (VADs) provide mechanical circulatory support to offload the work of one or both ventricles during heart failure. They are used in the clinical setting as destination therapy, as bridge to transplant, or more recently as bridge to recovery to allow for myocardial remodeling. Recent developments in computational simulation allow for detailed assessment of VAD hemodynamics for device design and optimization for both children and adults. Here, we provide a focused review of the recent literature on finite element methods and optimization for VAD simulations. As VAD designs typically fall into two categories, pulsatile and continuous flow devices, we separately address computational challenges of both types of designs, and the interaction with the circulatory system with three representative case studies. In particular, we focus on recent advancements in finite element methodology that has increased the fidelity of VAD simulations. We outline key challenges, which extend to the incorporation of biological response such as thrombosis and hemolysis, as well as shape optimization methods and challenges in computational methodology. PMID:24449607

Randomized clinical trials in implant therapy: relationships among methodological, statistical, clinical, paratextual features and number of citations.

PubMed

Nieri, Michele; Clauser, Carlo; Franceschi, Debora; Pagliaro, Umberto; Saletta, Daniele; Pini-Prato, Giovanpaolo

2007-08-01

The aim of the present study was to investigate the relationships among reported methodological, statistical, clinical and paratextual variables of randomized clinical trials (RCTs) in implant therapy, and their influence on subsequent research. The material consisted of the RCTs in implant therapy published through the end of the year 2000. Methodological, statistical, clinical and paratextual features of the articles were assessed and recorded. The perceived clinical relevance was subjectively evaluated by an experienced clinician on anonymous abstracts. The impact on research was measured by the number of citations found in the Science Citation Index. A new statistical technique (Structural learning of Bayesian Networks) was used to assess the relationships among the considered variables. Descriptive statistics revealed that the reported methodology and statistics of RCTs in implant therapy were defective. Follow-up of the studies was generally short. The perceived clinical relevance appeared to be associated with the objectives of the studies and with the number of published images in the original articles. The impact on research was related to the nationality of the involved institutions and to the number of published images. RCTs in implant therapy (until 2000) show important methodological and statistical flaws and may not be appropriate for guiding clinicians in their practice. The methodological and statistical quality of the studies did not appear to affect their impact on practice and research. Bayesian Networks suggest new and unexpected relationships among the methodological, statistical, clinical and paratextual features of RCTs.

Finding clusters of similar events within clinical incident reports: a novel methodology combining case based reasoning and information retrieval

PubMed Central

Tsatsoulis, C; Amthauer, H

2003-01-01

A novel methodological approach for identifying clusters of similar medical incidents by analyzing large databases of incident reports is described. The discovery of similar events allows the identification of patterns and trends, and makes possible the prediction of future events and the establishment of barriers and best practices. Two techniques from the fields of information science and artificial intelligence have been integrated—namely, case based reasoning and information retrieval—and very good clustering accuracies have been achieved on a test data set of incident reports from transfusion medicine. This work suggests that clustering should integrate the features of an incident captured in traditional form based records together with the detailed information found in the narrative included in event reports. PMID:14645892

Salud Para Su Corazon (Health for Your Heart) Community Health Worker Model

PubMed Central

Balcazar, H.; Alvarado, M.; Ortiz, G.

2012-01-01

This article describes 6 Salud Para Su Corazon (SPSC) family of programs that have addressed cardiovascular disease risk reduction in Hispanic communities facilitated by community health workers (CHWs) or Promotores de Salud (PS). A synopsis of the programs illustrates the designs and methodological approaches that combine community-based participatory research for 2 types of settings: community and clinical. Examples are provided as to how CHWs can serve as agents of change in these settings. A description is presented of a sustainability framework for the SPSC family of programs. Finally, implications are summarized for utilizing the SPSC CHW/PS model to inform ambulatory care management and policy. PMID:21914992

Emergency medicine versus primary care: a case study of three prevalent, costly, and non-emergent diagnoses at a community teaching hospital.

PubMed

Martin, B C

2000-01-01

The high cost of emergency department (ED) care is often viewed as an area for achieving cost savings through reduced utilization for inappropriate conditions. The implementation of outpatient prospective payment for Medicare ED patients heightens scrutiny of costs and utilization in the ED versus primary care settings. Data from hospital clinical records, financial records, and a provider survey was used to develop a costing methodology and complete a comparative analysis of the cost of care for three diagnoses by setting. Total costs were significantly higher in the ED due primarily to differences in ancillary tests and prescription drugs ordered.

Improved Diagnostic Multimodal Biomarkers for Alzheimer's Disease and Mild Cognitive Impairment

PubMed Central

Martínez-Torteya, Antonio; Treviño, Víctor; Tamez-Peña, José G.

2015-01-01

The early diagnosis of Alzheimer's disease (AD) and mild cognitive impairment (MCI) is very important for treatment research and patient care purposes. Few biomarkers are currently considered in clinical settings, and their use is still optional. The objective of this work was to determine whether multimodal and nonpreviously AD associated features could improve the classification accuracy between AD, MCI, and healthy controls, which may impact future AD biomarkers. For this, Alzheimer's Disease Neuroimaging Initiative database was mined for case-control candidates. At least 652 baseline features extracted from MRI and PET analyses, biological samples, and clinical data up to February 2014 were used. A feature selection methodology that includes a genetic algorithm search coupled to a logistic regression classifier and forward and backward selection strategies was used to explore combinations of features. This generated diagnostic models with sizes ranging from 3 to 8, including well documented AD biomarkers, as well as unexplored image, biochemical, and clinical features. Accuracies of 0.85, 0.79, and 0.80 were achieved for HC-AD, HC-MCI, and MCI-AD classifications, respectively, when evaluated using a blind test set. In conclusion, a set of features provided additional and independent information to well-established AD biomarkers, aiding in the classification of MCI and AD. PMID:26106620

Using Electronic Medical Records to Assess the Effectiveness of Pharmacotherapy in Pain: A Review of Recent Observational Studies.

PubMed

Biltaji, Eman; Tak, Casey; Ma, Junjie; Ruiz-Negron, Natalia; Bellows, Brandon K

2016-09-01

Pain disorders affect a large number of individuals throughout the world and are costly. Although randomized clinical trials assess the efficacy (i.e., how well treatments work in controlled settings) of pain pharmacotherapy, clinical trials do not assess effectiveness (i.e., how well treatments work in real-world settings). The number of observational studies that use real-world data to assess the effectiveness of medications is increasing rapidly in many disease areas. It is important for clinicians to understand how real-world data may be used to assess the effectiveness of medications. This paper aims to review the current body of literature assessing the effectiveness of pain pharmacotherapy using medical records. To do this, a literature search was conducted to identify papers published between January 2013 and September 2015 that examined the effectiveness of pain pharmacotherapy using electronic medical records. The search found only three papers meeting these criteria, which were described, reviewed, and critiqued in this paper. Electronic medical records are an underutilized source of data to assess pain outcomes in real-world settings. Although there are many methodological challenges in using these data, there is also great opportunity to impact clinical practice and explore the real-world effectiveness of pharmacotherapy used in pain management.

Obtaining optic disc center and pixel region by automatic thresholding methods on morphologically processed fundus images.

PubMed

Marin, Diego; Gegundez-Arias, Manuel E; Suero, Angel; Bravo, Jose M

2015-02-01

Development of automatic retinal disease diagnosis systems based on retinal image computer analysis can provide remarkably quicker screening programs for early detection. Such systems are mainly focused on the detection of the earliest ophthalmic signs of illness and require previous identification of fundal landmark features such as optic disc (OD), fovea or blood vessels. A methodology for accurate center-position location and OD retinal region segmentation on digital fundus images is presented in this paper. The methodology performs a set of iterative opening-closing morphological operations on the original retinography intensity channel to produce a bright region-enhanced image. Taking blood vessel confluence at the OD into account, a 2-step automatic thresholding procedure is then applied to obtain a reduced region of interest, where the center and the OD pixel region are finally obtained by performing the circular Hough transform on a set of OD boundary candidates generated through the application of the Prewitt edge detector. The methodology was evaluated on 1200 and 1748 fundus images from the publicly available MESSIDOR and MESSIDOR-2 databases, acquired from diabetic patients and thus being clinical cases of interest within the framework of automated diagnosis of retinal diseases associated to diabetes mellitus. This methodology proved highly accurate in OD-center location: average Euclidean distance between the methodology-provided and actual OD-center position was 6.08, 9.22 and 9.72 pixels for retinas of 910, 1380 and 1455 pixels in size, respectively. On the other hand, OD segmentation evaluation was performed in terms of Jaccard and Dice coefficients, as well as the mean average distance between estimated and actual OD boundaries. Comparison with the results reported by other reviewed OD segmentation methodologies shows our proposal renders better overall performance. Its effectiveness and robustness make this proposed automated OD location and segmentation method a suitable tool to be integrated into a complete prescreening system for early diagnosis of retinal diseases. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Lean and Six Sigma in acute care: a systematic review of reviews.

PubMed

Deblois, Simon; Lepanto, Luigi

2016-01-01

The purpose of this paper is to present a systematic review of literature reviews, summarizing how Lean and Six Sigma management techniques have been implemented in acute care settings to date, and assessing their impact. To aid decision makers who wish to use these techniques by identifying the sectors of activity most often targeted, the main results of the interventions, as well as barriers and facilitators involved. To identify areas of future research. A literature search was conducted, using eight databases. The methodological quality of the selected reviews was appraised with AMSTAR. A narrative synthesis was performed according to the guidelines proposed by Popay et al. (2006). Data were reported according to PRISMA. The literature search identified 149 publications published from 1999 to January 2015. Seven literature reviews were included into the systematic review, upon appraisal. The overall quality of the evidence was poor to fair. The clinical settings most described were specialized health care services, including operating suites, intensive care units and emergency departments. The outcomes most often appraised related to processes and quality. The evidence suggests that Lean and Six Sigma are better adapted to settings where processes involve a linear sequence of events. There is a need for more studies of high methodological quality to better understand the effects of these approaches as well as the factors of success and barriers to their implementation. Field studies comparing the effects of Lean and Six Sigma to those of other process redesign or quality improvement efforts would bring a significant contribution to the body of knowledge. Lean and Six Sigma can be considered valuable process optimization approaches in acute health care settings. The success of their implementation requires significant participation of clinical personnel from the frontline as well as clinical leaders and managers. More research is needed to better understand the factors of success and the barriers to their implementation, as well as their long-term impact. This is the first broad systematic review of reviews, synthesizing data pertaining to implementation issues and results in acute care settings, to be published. It will benefit health care managers assessing the potential of these approaches and the potential drawbacks associated with their implementation. Moreover, it identifies directions for future research.

The HIV care cascade: a systematic review of data sources, methodology and comparability.

PubMed

Medland, Nicholas A; McMahon, James H; Chow, Eric P F; Elliott, Julian H; Hoy, Jennifer F; Fairley, Christopher K

2015-01-01

The cascade of HIV diagnosis, care and treatment (HIV care cascade) is increasingly used to direct and evaluate interventions to increase population antiretroviral therapy (ART) coverage, a key component of treatment as prevention. The ability to compare cascades over time, sub-population, jurisdiction or country is important. However, differences in data sources and methodology used to construct the HIV care cascade might limit its comparability and ultimately its utility. Our aim was to review systematically the different methods used to estimate and report the HIV care cascade and their comparability. A search of published and unpublished literature through March 2015 was conducted. Cascades that reported the continuum of care from diagnosis to virological suppression in a demographically definable population were included. Data sources and methods of measurement or estimation were extracted. We defined the most comparable cascade elements as those that directly measured diagnosis or care from a population-based data set. Thirteen reports were included after screening 1631 records. The undiagnosed HIV-infected population was reported in seven cascades, each of which used different data sets and methods and could not be considered to be comparable. All 13 used mandatory HIV diagnosis notification systems to measure the diagnosed population. Population-based data sets, derived from clinical data or mandatory reporting of CD4 cell counts and viral load tests from all individuals, were used in 6 of 12 cascades reporting linkage, 6 of 13 reporting retention, 3 of 11 reporting ART and 6 of 13 cascades reporting virological suppression. Cascades with access to population-based data sets were able to directly measure cascade elements and are therefore comparable over time, place and sub-population. Other data sources and methods are less comparable. To ensure comparability, countries wishing to accurately measure the cascade should utilize complete population-based data sets from clinical data from elements of a centralized healthcare setting, where available, or mandatory CD4 cell count and viral load test result reporting. Additionally, virological suppression should be presented both as percentage of diagnosed and percentage of estimated total HIV-infected population, until methods to calculate the latter have been standardized.

Usability testing in medical informatics: cognitive approaches to evaluation of information systems and user interfaces.

PubMed Central

Kushniruk, A. W.; Patel, V. L.; Cimino, J. J.

1997-01-01

This paper describes an approach to the evaluation of health care information technologies based on usability engineering and a methodological framework from the study of medical cognition. The approach involves collection of a rich set of data including video recording of health care workers as they interact with systems, such as computerized patient records and decision support tools. The methodology can be applied in the laboratory setting, typically involving subjects "thinking aloud" as they interact with a system. A similar approach to data collection and analysis can also be extended to study of computer systems in the "live" environment of hospital clinics. Our approach is also influenced from work in the area of cognitive task analysis, which aims to characterize the decision making and reasoning of subjects of varied levels of expertise as they interact with information technology in carrying out representative tasks. The stages involved in conducting cognitively-based usability analyses are detailed and the application of such analysis in the iterative process of system and interface development is discussed. PMID:9357620

Using Eye Trackers for Usability Evaluation of Health Information Technology: A Systematic Literature Review

PubMed Central

Yang, Yushi

2015-01-01

Background Eye-tracking technology has been used to measure human cognitive processes and has the potential to improve the usability of health information technology (HIT). However, it is still unclear how the eye-tracking method can be integrated with other traditional usability methodologies to achieve its full potential. Objective The objective of this study was to report on HIT evaluation studies that have used eye-tracker technology, and to envision the potential use of eye-tracking technology in future research. Methods We used four reference databases to initially identify 5248 related papers, which resulted in only 9 articles that met our inclusion criteria. Results Eye-tracking technology was useful in finding usability problems in many ways, but is still in its infancy for HIT usability evaluation. Limited types of HITs have been evaluated by eye trackers, and there has been a lack of evaluation research in natural settings. Conclusions More research should be done in natural settings to discover the real contextual-based usability problems of clinical and mobile HITs using eye-tracking technology with more standardized methodologies and guidance. PMID:27026079

Anxiety, depression, and PTSD following cardiac arrest: a systematic review of the literature.

PubMed

Wilder Schaaf, Kathryn P; Artman, Laura K; Peberdy, Mary Ann; Walker, William C; Ornato, Joseph P; Gossip, Michelle R; Kreutzer, Jeffrey S

2013-07-01

Identify the occurrence rate of post-arrest psychological distress; evaluate methodological approaches; suggest future research priorities; address clinical implications. The electronic databases PubMed/MEDLINE and PsychInfo/APA PsycNET were utilized to search for terms including 'Cardiac Arrest', 'Therapeutic Hypothermia' and 'Depression', 'Anxiety', 'Quality of Life', 'Posttraumatic Stress Disorder (PTSD)', 'Psychological Outcomes', 'Hospital Anxiety and Depression Scale (HADS)', and 'Beck Depression Inventory (BDI)'. High rates of psychological distress have been reported after OHCA. Specifically, incidence rates of depression have ranged from 14% to 45%; anxiety rates have ranged from 13% to 61%; PTSD rates reportedly range from 19% to 27%. Variability between studies is likely attributable to methodological variations relating to measures used, time since arrest, and research setting. Given the occurrence rate of psychological distress after OHCA, psychological screening and early intervention seems indicated in the cardiac arrest population. Further studies are needed to better establish occurrence rates in both inpatient and outpatient settings, determine appropriate measures and normative cut off scores, and decide on the most appropriate method of intervention. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Glocal Clinical Registries: Pacemaker Registry Design and Implementation for Global and Local Integration – Methodology and Case Study

PubMed Central

da Silva, Kátia Regina; Costa, Roberto; Crevelari, Elizabeth Sartori; Lacerda, Marianna Sobral; de Moraes Albertini, Caio Marcos; Filho, Martino Martinelli; Santana, José Eduardo; Vissoci, João Ricardo Nickenig; Pietrobon, Ricardo; Barros, Jacson V.

2013-01-01

Background The ability to apply standard and interoperable solutions for implementing and managing medical registries as well as aggregate, reproduce, and access data sets from legacy formats and platforms to advanced standard formats and operating systems are crucial for both clinical healthcare and biomedical research settings. Purpose Our study describes a reproducible, highly scalable, standard framework for a device registry implementation addressing both local data quality components and global linking problems. Methods and Results We developed a device registry framework involving the following steps: (1) Data standards definition and representation of the research workflow, (2) Development of electronic case report forms using REDCap (Research Electronic Data Capture), (3) Data collection according to the clinical research workflow and, (4) Data augmentation by enriching the registry database with local electronic health records, governmental database and linked open data collections, (5) Data quality control and (6) Data dissemination through the registry Web site. Our registry adopted all applicable standardized data elements proposed by American College Cardiology / American Heart Association Clinical Data Standards, as well as variables derived from cardiac devices randomized trials and Clinical Data Interchange Standards Consortium. Local interoperability was performed between REDCap and data derived from Electronic Health Record system. The original data set was also augmented by incorporating the reimbursed values paid by the Brazilian government during a hospitalization for pacemaker implantation. By linking our registry to the open data collection repository Linked Clinical Trials (LinkedCT) we found 130 clinical trials which are potentially correlated with our pacemaker registry. Conclusion This study demonstrates how standard and reproducible solutions can be applied in the implementation of medical registries to constitute a re-usable framework. Such approach has the potential to facilitate data integration between healthcare and research settings, also being a useful framework to be used in other biomedical registries. PMID:23936257

Giving them a good start: informatics support of newborn screening and clinical care.

PubMed

Wetter, T; Haschler, I; Ho, S; Hoffmann, G F; Linderkamp, O; Philipp, F; Skonetzki, S

2005-01-01

Newborns are a vulnerable population: Exposed to dramatically changing environmental conditions, potentially suffering from impairments that cannot realistically be diagnosed during pregnancy, with the risk that unfavorable conditions escalate fast. We have investigated informatics methods and tools to make screening for congenital diseases and containment of critical processes that start in the first days safer and more efficient. This poster present a set of three different methodological approaches that all aim at comprehensive improvement of neonatal care.

Recommendation for measuring clinical outcome in distal radius fractures: a core set of domains for standardized reporting in clinical practice and research.

PubMed

Goldhahn, Jörg; Beaton, Dorcas; Ladd, Amy; Macdermid, Joy; Hoang-Kim, Amy

2014-02-01

Lack of standardization of outcome measurement has hampered an evidence-based approach to clinical practice and research. We adopted a process of reviewing evidence on current use of measures and appropriate theoretical frameworks for health and disability to inform a consensus process that was focused on deriving the minimal set of core domains in distal radius fracture. We agreed on the following seven core recommendations: (1) pain and function were regarded as the primary domains, (2) very brief measures were needed for routine administration in clinical practice, (3) these brief measures could be augmented by additional measures that provide more detail or address additional domains for clinical research, (4) measurement of pain should include measures of both intensity and frequency as core attributes, (5) a numeric pain scale, e.g. visual analogue scale or visual numeric scale or the pain subscale of the patient-reported wrist evaluation (PRWE) questionnaires were identified as reliable, valid and feasible measures to measure these concepts, (6) for function, either the Quick Disability of the arm, shoulder and hand questionnaire or PRWE-function subscale was identified as reliable, valid and feasible measures, and (7) a measure of participation and treatment complications should be considered core outcomes for both clinical practice and research. We used a sound methodological approach to form a comprehensive foundation of content for outcomes in the area of distal radius fractures. We recommend the use of symptom and function as separate domains in the ICF core set in clinical research or practice for patients with wrist fracture. Further research is needed to provide more definitive measurement properties of measures across all domains.

A methodology for successfully producing global translations of patient reported outcome measures for use in multiple countries.

PubMed

Two, Rebecca; Verjee-Lorenz, Aneesa; Clayson, Darren; Dalal, Mehul; Grotzinger, Kelly; Younossi, Zobair M

2010-01-01

The production of accurate and culturally relevant translations of patient reported outcome (PRO) measures is essential for the success of international clinical trials. Although there are many reports in publication regarding the translation of PRO measures, the techniques used to produce single translations for use in multiple countries (global translations) are not well documented. This article addresses this apparent lack of documentation and presents the methodology used to create global translations of the Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV). The challenges of creating a translation for use in multiple countries are discussed, and the criteria for a global translation project explained. Based on a thorough translation and linguistic validation methodology including a concept elaboration, multiple forward translations, two back translations, reviews by in-country clinicians and the instrument developer, pilot testing in each target country and multiple sets of proofreading, the key concept of the global translation methodology is consistent international harmonization, achieved through the involvement of linguists from each target country at every stage of the process. This methodology enabled the successful resolution of the translation issues encountered, and resulted in consistent translations of the CLDQ-HCV that were linguistically and culturally appropriate for all target countries.

77 FR 10767 - Rate Adjustments for Indian Irrigation Projects

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-23

... Irrigation Project on the proposed rates about the following issues: (1) The methodology for O&M rate setting... BIA's responses are provided below. Comment: The BIA's methodology for setting the 2013 O&M assessment rate was unreasonable. Response: The methodology used by the BIA to determine the 2013 O&M assessment...

Methodological, Theoretical, Infrastructural, and Design Issues in Conducting Good Outcome Studies

ERIC Educational Resources Information Center

Kelly, Michael P.; Moore, Tessa A.

2011-01-01

This article outlines a set of methodological, theoretical, and other issues relating to the conduct of good outcome studies. The article begins by considering the contribution of evidence-based medicine to the methodology of outcome research. The lessons which can be applied in outcome studies in nonmedical settings are described. The article…

A systematic review investigating the relationship between efficacy and stimulation parameters when using transcutaneous electrical nerve stimulation after knee arthroplasty.

PubMed

Beckwée, David; Bautmans, Ivan; Swinnen, Eva; Vermet, Yorick; Lefeber, Nina; Lievens, Pierre; Vaes, Peter

2014-01-01

To evaluate the clinical efficacy of transcutaneous electric nerve stimulation in the treatment of postoperative knee arthroplasty pain and to relate these results to the stimulation parameters used. PubMed, Pedro and Web of Knowledge were systematically screened for studies investigating effects of transcutaneous electric nerve stimulation on postoperative knee arthroplasty pain. Studies were screened for their methodological and therapeutical quality. We appraised the influence of the stimulation settings used and indicated whether or not a neurophysiological and/or mechanistic rationale was given for these stimulation settings. A total of 5 articles met the inclusion criteria. In total, 347 patients were investigated. The number of patients who received some form of transcutaneous electric nerve stimulation was 117, and 54 patients received sham transcutaneous electric nerve stimulation. Pain was the primary outcome in all studies. The stimulation settings used in the studies (n = 2) that reported significant effects differed from the others as they implemented a submaximal stimulation intensity. Stimulation parameters were heterogeneous, and only one study provided a rationale for them. This review reveals that an effect of transcutaneous electric nerve stimulation might have been missed due to low methodological and therapeutical quality. Justifying the choice of transcutaneous electric nerve stimulation parameters may improve therapeutical quality.

The EFPA Test-Review Model: When Good Intentions Meet a Methodological Thought Disorder

PubMed Central

2017-01-01

The European Federation of Psychologists’ Associations (EFPA) has issued sets of test standards and guidelines for psychometric test reviews without any attempt to address the critical content of many substantive publications by measurement experts such as Joel Michell. For example, he has argued that the psychometric test-theory which underpins classical and modern IRT psychometrics is “pathological”, with the entire profession of psychometricians suffering from a methodological thought disorder. With the advent of new kinds of assessment now being created by the “Next Generation” of psychologists which no longer conform to the item-based, statistical test theory generated last century, a new framework is set out for constructing evidence-bases suitable for these “Next Generation” of assessments, which avoids the illusory beliefs of equal-interval or quantitatively structured psychological attributes. Finally, with no systematic or substantive refutations of the logic, axioms, and evidence set out by Michell and others; it is concluded psychologists and their professional associations remain in denial. As with the eventual demise of a similar attempt to maintain the status quo of professional beliefs within forensic clinical psychology and psychiatry during the last century, those following certain EFPA guidelines might now find themselves required to justify their professional beliefs in legal rather than academic environments. PMID:29403661

[EBM, guidelines, protocols: knowledge, attitudes and utilization in the era of law on professional responsibility and safety of health care.

PubMed

Minozzi, Silvia; Ruggiero, Francesca; Capobussi, Matteo; González-Lorenzo, Marien; La Regina, Micaela; Squizzato, Alessandro; Moja, Lorenzo; Orlandini, Francesco

2018-05-01

The knowledge of principles and methods of Evidence Based Medicine (EBM) and the use of Clinical Practice Guidelines to inform clinical decisions are recognised as key instruments to improve the quality of care. In Italy the Parliament has revised the legal system that rules the responsibilities of health professionals and health care safety, prescribing health professionals to adhere to guidelines and good practice recommendations. The objective of the study was to evaluate guidelines and clinical pathways developed at local level and to assess knowledge and attitudes of healthcare workers toward EBM and guidelines. At the l'ASL 5 Liguria La Spezia we performed a census of all the documents registered as "guidelines" or "clinical pathways" at the Direzione Generale by the end of May 2016. We assessed their methodological quality by the "Recognition Card for Clinical Pathways Production and Revision Activity" prepared by the Ligurian Region. We conducted semi-structured interviews to assess attitudes and knowledge of healthcare workers. We found 17 clinical pathways, 41% contained organizational/management recommendations, and 59% contained mainly clinical recommendations. 41% was produced by assimilating already existing guidelines. 29% did not describe the method of production. Only one document linked directly each recommendation with scientific evidence. 10 healthcare workers out of 32 invited actually accepted to conduct the interview. Respondents showed a positive attitude toward the EBM and guidelines but a poor knowledge of the methodology of production and the instruments and principles for critical appraising of scientific literature. Nobody knew the GRADE approach. The most relevant barriers identified were: lack of time, poor knowledge of English and statistical methods, poor applicability of the international guidelines to local setting and real patients encountered in clinical practice. Despite the initiatives of the legislator toward civil responsibility and safety of care that should increase the use of guidelines, we found an overall poor knowledge of the concepts of EBM and method of guidelines production. Though the attitudes of responders to the interview were positive, barriers to use seemed to be predominant and considered more as obstacles than as a stimulus. In peripheral settings or in hospitals of medium/small size, clinical guidelines could remain confined to a merely juridical role, with weak impact on professional practice.

SU-F-R-10: Selecting the Optimal Solution for Multi-Objective Radiomics Model

DOE Office of Scientific and Technical Information (OSTI.GOV)

Zhou, Z; Folkert, M; Wang, J

2016-06-15

Purpose: To develop an evidential reasoning approach for selecting the optimal solution from a Pareto solution set obtained by a multi-objective radiomics model for predicting distant failure in lung SBRT. Methods: In the multi-objective radiomics model, both sensitivity and specificity are considered as the objective functions simultaneously. A Pareto solution set with many feasible solutions will be resulted from the multi-objective optimization. In this work, an optimal solution Selection methodology for Multi-Objective radiomics Learning model using the Evidential Reasoning approach (SMOLER) was proposed to select the optimal solution from the Pareto solution set. The proposed SMOLER method used the evidentialmore » reasoning approach to calculate the utility of each solution based on pre-set optimal solution selection rules. The solution with the highest utility was chosen as the optimal solution. In SMOLER, an optimal learning model coupled with clonal selection algorithm was used to optimize model parameters. In this study, PET, CT image features and clinical parameters were utilized for predicting distant failure in lung SBRT. Results: Total 126 solution sets were generated by adjusting predictive model parameters. Each Pareto set contains 100 feasible solutions. The solution selected by SMOLER within each Pareto set was compared to the manually selected optimal solution. Five-cross-validation was used to evaluate the optimal solution selection accuracy of SMOLER. The selection accuracies for five folds were 80.00%, 69.23%, 84.00%, 84.00%, 80.00%, respectively. Conclusion: An optimal solution selection methodology for multi-objective radiomics learning model using the evidential reasoning approach (SMOLER) was proposed. Experimental results show that the optimal solution can be found in approximately 80% cases.« less

Assessing Patient Reported Outcomes Measures via Phone Interviews Versus Patient Self-Survey in the Clinic: Are We Measuring the Same Thing?

PubMed

Adogwa, Owoicho; Elsamadicy, Aladine A; Cheng, Joseph; Bagley, Carlos

2016-03-01

Longitudinally following patients requires a full-time employee (FTE)-dependent data inflow infrastructure. There are efforts to capture patient-reported outcomes (PROs) by the use of non-FTE-dependent methodologies. In this study, we set out to assess the reliability of PRO data captured via FTE-dependent compared with non-FTE-dependent methodologies. A total of 119 adult patients (65 men) who underwent 1-and 2-level lumbar fusions at Duke University Medical Center were enrolled in this prospective study. Enrollment criteria included available demographic, clinical, and PRO data. All patients completed 2 sets of questionnaires--the first a phone interviews and the second a self-survey. There was at least a 2-week period between the phone interviews and self-survey. Questionnaires included the Oswestry Disability Index (ODI), the visual analog scale for back pain (VAS-BP), and the visual analog scale for leg pain (VAS-LP). Repeated-measures analysis of variance was used to compare the reliability of baseline PRO data captured. A total of 39.49% of patients were smokers, 21.00% had diabetes, and 11.76% had coronary artery disease; 26.89% reported history of anxiety disorder, and 28.57% reported history of depression. A total of 97.47% of patients had a high-school diploma or General Education Development, and 49.57% attained a 4-year college degree or postgraduate degree. We observed a high correlation between baseline PRO data captured between FTE-dependent versus non-FTE dependent methodologies (ODI: r = -0.89, VAS-BP: r = 0.74, VAS-LP: r = 0.70). There was no difference in PROs of baseline pain and functional disability between FTE-dependent and non-FTE-dependent methodologies: baseline ODI (FTE-dependent: 47.73 ± 16.77 [mean ± SD] vs. non-FTE-dependent: 45.81 ± 12.11, P = 0.39), VAS-LP (FTE-dependent: 6.13 ± 2.78 vs. non-FTE-dependent: 6.46 ± 2.79, P = 0.36) and VAS-BP (FTE-dependent: 6.33 ± 2.90 vs. non-FTE-dependent: 6.53 ± 2.48, P = 0.57). Our study suggests that there is great reliability between PRO data captured between FTE-dependent and non-FTE-dependent methodologies. Copyright © 2016 Elsevier Inc. All rights reserved.

[Methodology for clinical research in Orthodontics, the assets of the beOrtho website].

PubMed

Ruiz, Martial; Thibult, François

2014-06-01

The rules applying to the "evidence-based" methodology strongly influenced the clinical research in orthodontics. However, the implementation of clinical studies requires rigour, important statistical and methodological knowledge, as well as a reliable environment in order to compile and store the data obtained from research. We developed the project "beOrtho.com" (based on orthodontic evidence) in order to fill up the gap between our desire to drive clinical research and the necessity of methodological rigour in the exploitation of its results. BeOrtho website was created to answer the issue of sample recruitment, data compilation and storage, while providing help for the methodological design of clinical studies. It allows the development and monitoring of clinical studies, as well as the creation of databases. On the other hand, we designed an evaluation grid for clinical studies which helps developing systematic reviews. In order to illustrate our point, we tested a research protocol evaluating the interest of the mandibular advancement in the framework of Class II treatment. © EDP Sciences, SFODF, 2014.

[A historical view of the specialty of clinical microbiology].

PubMed

Pérez, Evelio Perea; Álvarez, Rogelio Martín

2010-10-01

Clinical microbiology today is a well established specialty in Spain whose development has necessarily been linked to improvements in the diagnosis, treatment and prevention of infectious diseases. Over time, clinical, teaching, and research structures have been organized around these diseases. In addition, a scientific society for specialists in infectious diseases (Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica) has been set up, which in turn, publishes the journal ENFERMEDADES INFECCIOSAS Y MICROBIOLOGÍA CLÍNICA, and organizes congresses, meetings, working groups and a quality control program, etc. Clinical microbiologists will continue to be needed to meet future challenges (identification of new pathogenic microorganisms, methodological changes, diagnostic quality and speed, nosocomial infections, the development of antimicrobial resistance, etc.), which constitute a well-defined area of knowledge specific to our specialty. Copyright © 2010 Elsevier España S.L. All rights reserved.

Applying risk adjusted cost-effectiveness (RAC-E) analysis to hospitals: estimating the costs and consequences of variation in clinical practice.

PubMed

Karnon, Jonathan; Caffrey, Orla; Pham, Clarabelle; Grieve, Richard; Ben-Tovim, David; Hakendorf, Paul; Crotty, Maria

2013-06-01

Cost-effectiveness analysis is well established for pharmaceuticals and medical technologies but not for evaluating variations in clinical practice. This paper describes a novel methodology--risk adjusted cost-effectiveness (RAC-E)--that facilitates the comparative evaluation of applied clinical practice processes. In this application, risk adjustment is undertaken with a multivariate matching algorithm that balances the baseline characteristics of patients attending different settings (e.g., hospitals). Linked, routinely collected data are used to analyse patient-level costs and outcomes over a 2-year period, as well as to extrapolate costs and survival over patient lifetimes. The study reports the relative cost-effectiveness of alternative forms of clinical practice, including a full representation of the statistical uncertainty around the mean estimates. The methodology is illustrated by a case study that evaluates the relative cost-effectiveness of services for patients presenting with acute chest pain across the four main public hospitals in South Australia. The evaluation finds that services provided at two hospitals were dominated, and of the remaining services, the more effective hospital gained life years at a low mean additional cost and had an 80% probability of being the most cost-effective hospital at realistic cost-effectiveness thresholds. Potential determinants of the estimated variation in costs and effects were identified, although more detailed analyses to identify specific areas of variation in clinical practice are required to inform improvements at the less cost-effective institutions. Copyright © 2012 John Wiley & Sons, Ltd.

Applying Advanced Analytical Approaches to Characterize the Impact of Specific Clinical Gaps and Profiles on the Management of Rheumatoid Arthritis.

PubMed

Ruiz-Cordell, Karyn D; Joubin, Kathy; Haimowitz, Steven

2016-01-01

The goal of this study was to add a predictive modeling approach to the meta-analysis of continuing medical education curricula to determine whether this technique can be used to better understand clinical decision making. Using the education of rheumatologists on rheumatoid arthritis management as a model, this study demonstrates how the combined methodology has the ability to not only characterize learning gaps but also identify those proficiency areas that have the greatest impact on clinical behavior. The meta-analysis included seven curricula with 25 activities. Learners who identified as rheumatologists were evaluated across multiple learning domains, using a uniform methodology to characterize learning gains and gaps. A performance composite variable (called the treatment individualization and optimization score) was then established as a target upon which predictive analytics were conducted. Significant predictors of the target included items related to the knowledge of rheumatologists and confidence concerning 1) treatment guidelines and 2) tests that measure disease activity. In addition, a striking demographic predictor related to geographic practice setting was also identified. The results demonstrate the power of advanced analytics to identify key predictors that influence clinical behaviors. Furthermore, the ability to provide an expected magnitude of change if these predictors are addressed has the potential to substantially refine educational priorities to those drivers that, if targeted, will most effectively overcome clinical barriers and lead to the greatest success in achieving treatment goals.

Whither cognitive bias modification research? Commentary on the special section articles.

PubMed

MacLeod, Colin; Koster, Ernst H W; Fox, Elaine

2009-02-01

This commentary reviews key theoretical, methodological, and clinical issues raised by recent research on cognitive bias modification (CBM). The authors identify the major ways in which the new work reported within this special section extends earlier CBM research. In particular, they note that it considers a wider range of participants, includes a greater diversity of symptoms measures, and targets for change a broader array of processing biases than previously has been the case. Furthermore, they point out that the present work develops and employs a more diverse arsenal of bias modification procedures, in some cases delivered across extended periods of time within naturalistic settings. They also draw attention to methodological limitations associated with the current studies, offering recommendations concerning how future CBM research might profitably build upon these exciting new directions while overcoming such limitations. Finally, they evaluate the theoretical and applied implications of the reported findings, discussing their capacity to illuminate the causal contributions made by cognitive bias to emotional vulnerability and their promise concerning the potential therapeutic value of CBM as a clinical tool.

Projecting adverse event incidence rates using empirical Bayes methodology.

PubMed

Ma, Guoguang Julie; Ganju, Jitendra; Huang, Jing

2016-08-01

Although there is considerable interest in adverse events observed in clinical trials, projecting adverse event incidence rates in an extended period can be of interest when the trial duration is limited compared to clinical practice. A naïve method for making projections might involve modeling the observed rates into the future for each adverse event. However, such an approach overlooks the information that can be borrowed across all the adverse event data. We propose a method that weights each projection using a shrinkage factor; the adverse event-specific shrinkage is a probability, based on empirical Bayes methodology, estimated from all the adverse event data, reflecting evidence in support of the null or non-null hypotheses. Also proposed is a technique to estimate the proportion of true nulls, called the common area under the density curves, which is a critical step in arriving at the shrinkage factor. The performance of the method is evaluated by projecting from interim data and then comparing the projected results with observed results. The method is illustrated on two data sets. © The Author(s) 2013.

Clinical relevance in anesthesia journals.

PubMed

Lauritsen, Jakob; Møller, Ann M

2006-04-01

The purpose of this review is to present the latest knowledge and research on the definition and distribution of clinically relevant articles in anesthesia journals. It will also discuss the importance of the chosen methodology and outcome of articles. In the last few years, more attention has been paid to evidence-based medicine in anesthesia. Several articles on the subject have focused on the need to base clinical decisions on sound research employing both methodological rigor and clinically relevant outcomes. The number of systematic reviews in anesthesia literature is increasing as well as the focus on diminishing the number of surrogate outcomes. It has been shown that the impact factor is not a valid measure of establishing the level of clinical relevance to a journal. This review presents definitions of clinically relevant anesthesia articles. A clinically relevant article employs both methodological rigor and a clinically relevant outcome. The terms methodological rigor and clinical outcomes are fully discussed in the review as well as problems with journal impact factors.

Methodology and technical requirements of the galectin-3 test for the preoperative characterization of thyroid nodules.

PubMed

Bartolazzi, Armando; Bellotti, Carlo; Sciacchitano, Salvatore

2012-01-01

In the last decade, the β-galactosyl binding protein galectin-3 has been the object of extensive molecular, structural, and functional studies aimed to clarify its biological role in cancer. Multicenter studies also contributed to discover the potential clinical value of galectin-3 expression analysis in distinguishing, preoperatively, benign from malignant thyroid nodules. As a consequence galectin-3 is receiving significant attention as tumor marker for thyroid cancer diagnosis, but some conflicting results mostly owing to methodological problems have been published. The possibility to apply preoperatively a reliable galectin-3 test method on fine needle aspiration biopsy (FNA)-derived thyroid cells represents an important achievement. When correctly applied, the method reduces consistently the gray area of thyroid FNA cytology, contributing to avoid unnecessary thyroid surgery. Although the efficacy and reliability of the galectin-3 test method have been extensively proved in several studies, its translation in the clinical setting requires well-standardized reagents and procedures. After a decade of experimental work on galectin-3-related basic and translational research projects, the major methodological problems that may potentially impair the diagnostic performance of galectin-3 immunotargeting are highlighted and discussed in detail. A standardized protocol for a reliable galectin-3 expression analysis is finally provided. The aim of this contribution is to improve the clinical management of patients with thyroid nodules, promoting the preoperative use of a reliable galectin-3 test method as ancillary technique to conventional thyroid FNA cytology. The final goal is to decrease unnecessary thyroid surgery and its related social costs.

Machine learning classification of medication adherence in patients with movement disorders using non-wearable sensors.

PubMed

Tucker, Conrad S; Behoora, Ishan; Nembhard, Harriet Black; Lewis, Mechelle; Sterling, Nicholas W; Huang, Xuemei

2015-11-01

Medication non-adherence is a major concern in the healthcare industry and has led to increases in health risks and medical costs. For many neurological diseases, adherence to medication regimens can be assessed by observing movement patterns. However, physician observations are typically assessed based on visual inspection of movement and are limited to clinical testing procedures. Consequently, medication adherence is difficult to measure when patients are away from the clinical setting. The authors propose a data mining driven methodology that uses low cost, non-wearable multimodal sensors to model and predict patients' adherence to medication protocols, based on variations in their gait. The authors conduct a study involving Parkinson's disease patients that are "on" and "off" their medication in order to determine the statistical validity of the methodology. The data acquired can then be used to quantify patients' adherence while away from the clinic. Accordingly, this data-driven system may allow for early warnings regarding patient safety. Using whole-body movement data readings from the patients, the authors were able to discriminate between PD patients on and off medication, with accuracies greater than 97% for some patients using an individually customized model and accuracies of 78% for a generalized model containing multiple patient gait data. The proposed methodology and study demonstrate the potential and effectiveness of using low cost, non-wearable hardware and data mining models to monitor medication adherence outside of the traditional healthcare facility. These innovations may allow for cost effective, remote monitoring of treatment of neurological diseases. Copyright © 2015 Elsevier Ltd. All rights reserved.

Machine Learning Classification of Medication Adherence in Patients with Movement Disorders Using Non-Wearable Sensors

PubMed Central

Tucker, Conrad; Behoora, Ishan; Nembhard, Harriet Black; Lewis, Mechelle; Sterling, Nicholas W; Huang, Xuemei

2017-01-01

Medication non-adherence is a major concern in the healthcare industry and has led to increases in health risks and medical costs. For many neurological diseases, adherence to medication regimens can be assessed by observing movement patterns. However, physician observations are typically assessed based on visual inspection of movement and are limited to clinical testing procedures. Consequently, medication adherence is difficult to measure when patients are away from the clinical setting. The authors propose a data mining driven methodology that uses low cost, non-wearable multimodal sensors to model and predict patients’ adherence to medication protocols, based on variations in their gait. The authors conduct a study involving Parkinson’s Disease patients that are “on” and “off” their medication in order to determine the statistical validity of the methodology. The data acquired can then be used to quantify patients’ adherence while away from the clinic. Accordingly, this data-driven system may allow for early warnings regarding patient safety. Using whole-body movement data readings from the patients, the authors were able to discriminate between PD patients on and off medication, with accuracies greater than 97% for some patients using an individually customized model and accuracies of 78% for a generalized model containing multiple patient gait data. The proposed methodology and study demonstrate the potential and effectiveness of using low cost, non-wearable hardware and data mining models to monitor medication adherence outside of the traditional healthcare facility. These innovations may allow for cost effective, remote monitoring of treatment of neurological diseases. PMID:26406881

How to emerge from the conservatism in clinical research methodology?

PubMed

Kotecki, Nuria; Penel, Nicolas; Awada, Ahmad

2017-09-01

Despite recent changes in clinical research methodology, many challenges remain in drug development methodology. Advances in molecular biology and cancer treatments have changed the clinical research landscape. Thus, we moved from empirical clinical oncology to molecular and immunological therapeutic approaches. Along with this move, adapted dose-limiting toxicities definitions, endpoints, and dose escalation methods have been proposed. Moreover, the classical frontier between phase I, phase II, and phase III has become unclear in particular for immunological approaches. So, investigators are facing major challenges in drug development methodology. We propose to individualize clinical research using innovative approaches to significantly improve patient outcomes and targeting what is considered unmet need. Integrating high level of translational research and performing well designed biomarker studies with great potential for clinical practice are of utmost importance. This could be performed within new models of clinical research networks and by building a strong collaboration between academic, cooperative groups, on-site investigators, and pharma.

Mapping new theoretical and methodological terrain for knowledge translation: contributions from critical realism and the arts

PubMed Central

Kontos, Pia C; Poland, Blake D

2009-01-01

Background Clinical practice guidelines have been a popular tool for the improvement of health care through the implementation of evidence from systematic research. Yet, it is increasingly clear that knowledge alone is insufficient to change practice. The social, cultural, and material contexts within which practice occurs may invite or reject innovation, complement or inhibit the activities required for success, and sustain or alter adherence to entrenched practices. However, knowledge translation (KT) models are limited in providing insight about how and why contextual contingencies interact, the causal mechanisms linking structural aspects of context and individual agency, and how these mechanisms influence KT. Another limitation of KT models is the neglect of methods to engage potential adopters of the innovation in critical reflection about aspects of context that influence practice, the relevance and meaning of innovation in the context of practice, and the identification of strategies for bringing about meaningful change. Discussion This paper presents a KT model, the Critical Realism and the Arts Research Utilization Model (CRARUM), that combines critical realism and arts-based methodologies. Critical realism facilitates understanding of clinical settings by providing insight into the interrelationship between its structures and potentials, and individual action. The arts nurture empathy, and can foster reflection on the ways in which contextual factors influence and shape clinical practice, and how they may facilitate or impede change. The combination of critical realism and the arts within the CRARUM model promotes the successful embedding of interventions, and greater impact and sustainability. Conclusion CRARUM has the potential to strengthen the science of implementation research by addressing the complexities of practice settings, and engaging potential adopters to critically reflect on existing and proposed practices and strategies for sustaining change. PMID:19123945

Efficacy of Monitoring Devices in Support of Prevention of Pressure Injuries: Systematic Review and Meta-analysis.

PubMed

Walia, Gurjot S; Wong, Alison L; Lo, Andrea Y; Mackert, Gina A; Carl, Hannah M; Pedreira, Rachel A; Bello, Ricardo; Aquino, Carla S; Padula, William V; Sacks, Justin M

2016-12-01

To present a systematic review of the literature assessing the efficacy of monitoring devices for reducing the risk of developing pressure injuries. This continuing education activity is intended for physicians, physician assistants, nurse practitioners, and nurses with an interest in skin and wound care. After participating in this educational activity, the participant should be better able to:1. Explain the methodology of the literature review and its results.2. Discuss the scope of the problem and the implications of the research. OBJECTIVE: To assess the efficacy of monitoring devices for reducing the risk of developing pressure injuries (PIs). The authors systematically reviewed the literature by searching PubMed/MEDLINE and CINAHL databases through January 2016. Articles included clinical trials and cohort studies that tested monitoring devices, evaluating PI risk factors on patients in acute and skilled nursing settings. The articles were scored using the Methodological Index for Non-randomized Studies. Using a standardized extraction form, the authors extracted patient inclusion/exclusion criteria, care setting, key baseline, description of monitoring device and methodology, number of patients included in each group, description of any standard of care, follow-up period, and outcomes. Of the identified 1866 publications, 9 met the inclusion criteria. The high-quality studies averaged Methodological Index for Non-randomized Studies scores of 19.4 for clinical trials and 12.2 for observational studies. These studies evaluated monitoring devices that measured interface pressure, subdermal tissue stress, motion, and moisture. Most studies found a statistically significant decrease in PIs; 2 studies were eligible for meta-analysis, demonstrating that use of monitoring devices was associated with an 88% reduction in the risk of developing PIs (Mantel-Haenszel risk ratio, 0.12; 95% confidence interval, 0.04-0.41; I = 0%). Pressure injury monitoring devices are associated with a strong reduction in the risk of developing PIs. These devices provide clinicians and patients with critical information to implement prevention guidelines. Randomized controlled trials would help assess which technologies are most effective at reducing the risk of developing PIs.

Clinical trials of homoeopathy.

PubMed Central

Kleijnen, J; Knipschild, P; ter Riet, G

1991-01-01

OBJECTIVE--To establish whether there is evidence of the efficacy of homoeopathy from controlled trials in humans. DESIGN--Criteria based meta-analysis. Assessment of the methodological quality of 107 controlled trials in 96 published reports found after an extensive search. Trials were scored using a list of predefined criteria of good methodology, and the outcome of the trials was interpreted in relation to their quality. SETTING--Controlled trials published world wide. MAIN OUTCOME MEASURES--Results of the trials with the best methodological quality. Trials of classical homoeopathy and several modern varieties were considered separately. RESULTS--In 14 trials some form of classical homoeopathy was tested and in 58 trials the same single homoeopathic treatment was given to patients with comparable conventional diagnosis. Combinations of several homoeopathic treatments were tested in 26 trials; isopathy was tested in nine trials. Most trials seemed to be of very low quality, but there were many exceptions. The results showed a positive trend regardless of the quality of the trial or the variety of homeopathy used. Overall, of the 105 trials with interpretable results, 81 trials indicated positive results whereas in 24 trials no positive effects of homoeopathy were found. The results of the review may be complicated by publication bias, especially in such a controversial subject as homoeopathy. CONCLUSIONS--At the moment the evidence of clinical trials is positive but not sufficient to draw definitive conclusions because most trials are of low methodological quality and because of the unknown role of publication bias. This indicates that there is a legitimate case for further evaluation of homoeopathy, but only by means of well performed trials. PMID:1825800

Methodological Considerations for Research With Black Male Victims of Violent Injury in an Urban Trauma Unit.

PubMed

St Vil, Christopher; Richardson, Joseph; Cooper, Carnell

2018-04-01

There is a body of research over the last three decades that has focused on the etiology of violence among victims of violent injury. This body of literature indicates that Black men are disproportionately represented among victims of violent injury seen in emergency departments and trauma centers across the country. Despite the disproportionate number of low-income young Black men treated for violent injury in urban trauma units and the growing body of literature accompanying it, little is known about the unique methodological challenges violent injury researchers face when conducting research on this vulnerable population in a clinical setting. This article describes the unique and often nuanced methodological difficulties a research team encountered while conducting a longitudinal qualitative study on risk factors for repeat violent injury among low-income young Black male victims of violent injury treated at a Level II trauma center in the Eastern United States. Four methodological challenges are identified: (a) the identification and screening of participants, (b) recruitment and interviewing, (c) understanding hospital culture, policies, and procedures, and (d) retention and attrition of sample. Recommendations to overcome these challenges are offered.

KRAS mutation detection in colorectal cancer by a commercially available gene chip array compares well with Sanger sequencing.

PubMed

French, Deborah; Smith, Andrew; Powers, Martin P; Wu, Alan H B

2011-08-17

Binding of a ligand to the epidermal growth factor receptor (EGFR) stimulates various intracellular signaling pathways resulting in cell cycle progression, proliferation, angiogenesis and apoptosis inhibition. KRAS is involved in signaling pathways including RAF/MAPK and PI3K and mutations in this gene result in constitutive activation of these pathways, independent of EGFR activation. Seven mutations in codons 12 and 13 of KRAS comprise around 95% of the observed human mutations, rendering monoclonal antibodies against EGFR (e.g. cetuximab and panitumumab) useless in treatment of colorectal cancer. KRAS mutation testing by two different methodologies was compared; Sanger sequencing and AutoGenomics INFINITI® assay, on DNA extracted from colorectal cancers. Out of 29 colorectal tumor samples tested, 28 were concordant between the two methodologies for the KRAS mutations that were detected in both assays with the INFINITI® assay detecting a mutation in one sample that was indeterminate by Sanger sequencing and a third methodology; single nucleotide primer extension. This study indicates the utility of the AutoGenomics INFINITI® methodology in a clinical laboratory setting where technical expertise or access to equipment for DNA sequencing does not exist. Copyright © 2011 Elsevier B.V. All rights reserved.

The effectiveness of toolkits as knowledge translation strategies for integrating evidence into clinical care: a systematic review

PubMed Central

Yamada, Janet; Shorkey, Allyson; Barwick, Melanie; Widger, Kimberley; Stevens, Bonnie J

2015-01-01

Objectives The aim of this systematic review was to evaluate the effectiveness of toolkits as a knowledge translation (KT) strategy for facilitating the implementation of evidence into clinical care. Toolkits include multiple resources for educating and/or facilitating behaviour change. Design Systematic review of the literature on toolkits. Methods A search was conducted on MEDLINE, EMBASE, PsycINFO and CINAHL. Studies were included if they evaluated the effectiveness of a toolkit to support the integration of evidence into clinical care, and if the KT goal(s) of the study were to inform, share knowledge, build awareness, change practice, change behaviour, and/or clinical outcomes in healthcare settings, inform policy, or to commercialise an innovation. Screening of studies, assessment of methodological quality and data extraction for the included studies were conducted by at least two reviewers. Results 39 relevant studies were included for full review; 8 were rated as moderate to strong methodologically with clinical outcomes that could be somewhat attributed to the toolkit. Three of the eight studies evaluated the toolkit as a single KT intervention, while five embedded the toolkit into a multistrategy intervention. Six of the eight toolkits were partially or mostly effective in changing clinical outcomes and six studies reported on implementation outcomes. The types of resources embedded within toolkits varied but included predominantly educational materials. Conclusions Future toolkits should be informed by high-quality evidence and theory, and should be evaluated using rigorous study designs to explain the factors underlying their effectiveness and successful implementation. PMID:25869686

How can general paediatric training be optimised in highly specialised tertiary settings? Twelve tips from an interview-based study of trainees.

PubMed

Al-Yassin, Amina; Long, Andrew; Sharma, Sanjiv; May, Joanne

2017-01-01

Both general and subspecialty paediatric trainees undertake attachments in highly specialised tertiary hospitals. Trainee feedback suggests that mismatches in expectations between trainees and supervisors and a perceived lack of educational opportunities may lead to trainee dissatisfaction in such settings. With the 'Shape of Training' review (reshaping postgraduate training in the UK to focus on more general themes), this issue is likely to become more apparent. We wished to explore the factors that contribute to a positive educational environment and training experience and identify how this may be improved in highly specialised settings. General paediatric trainees working at all levels in subspecialty teams at a tertiary hospital were recruited (n=12). Semistructured interviews were undertaken to explore the strengths and weaknesses of training in such a setting and how this could be optimised. Appreciative inquiry methodology was used to identify areas of perceived best practice and consider how these could be promoted and disseminated. Twelve best practice themes were identified: (1) managing expectations by acknowledging the challenges; (2) educational contracting to identify learning needs and opportunities; (3) creative educational supervision; (4) centralised teaching events; (5) signposting learning opportunities; (6) curriculum-mapped pan-hospital teaching programmes; (7) local faculty groups with trainee representation; (8) interprofessional learning; (9) pastoral support systems; (10) crossover weeks to increase clinical exposure; (11) adequate clinical supervision; and (12) rota design to include teaching and clinic time. Tertiary settings have strengths, as well as challenges, for general paediatric training. Twelve trainee-generated tips have been identified to capitalise on the educational potential within these settings. Trainee feedback is essential to diagnose and improve educational environments and appreciative inquiry is a useful tool for this purpose.

How can general paediatric training be optimised in highly specialised tertiary settings? Twelve tips from an interview-based study of trainees

PubMed Central

Al-Yassin, Amina; Long, Andrew; Sharma, Sanjiv; May, Joanne

2017-01-01

Objectives Both general and subspecialty paediatric trainees undertake attachments in highly specialised tertiary hospitals. Trainee feedback suggests that mismatches in expectations between trainees and supervisors and a perceived lack of educational opportunities may lead to trainee dissatisfaction in such settings. With the ‘Shape of Training’ review (reshaping postgraduate training in the UK to focus on more general themes), this issue is likely to become more apparent. We wished to explore the factors that contribute to a positive educational environment and training experience and identify how this may be improved in highly specialised settings. Methods General paediatric trainees working at all levels in subspecialty teams at a tertiary hospital were recruited (n=12). Semistructured interviews were undertaken to explore the strengths and weaknesses of training in such a setting and how this could be optimised. Appreciative inquiry methodology was used to identify areas of perceived best practice and consider how these could be promoted and disseminated. Results Twelve best practice themes were identified: (1) managing expectations by acknowledging the challenges; (2) educational contracting to identify learning needs and opportunities; (3) creative educational supervision; (4) centralised teaching events; (5) signposting learning opportunities; (6) curriculum-mapped pan-hospital teaching programmes; (7) local faculty groups with trainee representation; (8) interprofessional learning; (9) pastoral support systems; (10) crossover weeks to increase clinical exposure; (11) adequate clinical supervision; and (12) rota design to include teaching and clinic time. Conclusions Tertiary settings have strengths, as well as challenges, for general paediatric training. Twelve trainee-generated tips have been identified to capitalise on the educational potential within these settings. Trainee feedback is essential to diagnose and improve educational environments and appreciative inquiry is a useful tool for this purpose. PMID:29637130

Mobile devices for the remote acquisition of physiological and behavioral biomarkers in psychiatric clinical research.

PubMed

W Adams, Zachary; McClure, Erin A; Gray, Kevin M; Danielson, Carla Kmett; Treiber, Frank A; Ruggiero, Kenneth J

2017-02-01

Psychiatric disorders are linked to a variety of biological, psychological, and contextual causes and consequences. Laboratory studies have elucidated the importance of several key physiological and behavioral biomarkers in the study of psychiatric disorders, but much less is known about the role of these biomarkers in naturalistic settings. These gaps are largely driven by methodological barriers to assessing biomarker data rapidly, reliably, and frequently outside the clinic or laboratory. Mobile health (mHealth) tools offer new opportunities to study relevant biomarkers in concert with other types of data (e.g., self-reports, global positioning system data). This review provides an overview on the state of this emerging field and describes examples from the literature where mHealth tools have been used to measure a wide array of biomarkers in the context of psychiatric functioning (e.g., psychological stress, anxiety, autism, substance use). We also outline advantages and special considerations for incorporating mHealth tools for remote biomarker measurement into studies of psychiatric illness and treatment and identify several specific opportunities for expanding this promising methodology. Integrating mHealth tools into this area may dramatically improve psychiatric science and facilitate highly personalized clinical care of psychiatric disorders. Copyright © 2016 Elsevier Ltd. All rights reserved.

A novel research design can aid disinvestment from existing health technologies with uncertain effectiveness, cost-effectiveness, and/or safety.

PubMed

Haines, Terry; O'Brien, Lisa; McDermott, Fiona; Markham, Donna; Mitchell, Deb; Watterson, Dina; Skinner, Elizabeth

2014-02-01

Disinvestment is critical for ensuring the long-term sustainability of health-care services. Key barriers to disinvestment are heterogeneity between research and clinical settings, absence of evidence of effectiveness of some health technologies, and exposure of patients and organizations to risks and poor outcomes. We aimed to develop a feasible research design that can evaluate disinvestment in health technologies of uncertain effectiveness or cost-effectiveness. This article (1) establishes the need for disinvestment methodologies, (2) identifies the ethical concerns and feasibility constraints of conventional research designs for this issue, (3) describes the planning, implementation, and analytical framework for a novel disinvestment-specific study design, and (4) describes potential limitations in application of this design. The stepped-wedge, roll-in cluster randomized controlled trial can facilitate the disinvestment process, whereas generating evidence to determine whether the decision to disinvest was sound in the clinical environment. A noninferiority research paradigm may be applied to this methodology to demonstrate that the removal of a health technology does not adversely affect outcomes. This research design can be applied across multiple fields and will assist determination of whether specific health technologies are clinically effective, cost-effective, and safe. Copyright © 2014 Elsevier Inc. All rights reserved.

Nursing Education Interventions for Managing Acute Pain in Hospital Settings: A Systematic Review of Clinical Outcomes and Teaching Methods.

PubMed

Drake, Gareth; de C Williams, Amanda C

2017-02-01

The objective of this review was to examine the effects of nursing education interventions on clinical outcomes for acute pain management in hospital settings, relating interventions to health care behavior change theory. Three databases were searched for nursing education interventions from 2002 to 2015 in acute hospital settings with clinical outcomes reported. Methodological quality was rated as strong, moderate, or weak using the Effective Public Health Practice Project Quality Assessment Tool for quantitative studies. The 12 eligible studies used varied didactic and interactive teaching methods. Several studies had weaknesses attributable to selection biases, uncontrolled confounders, and lack of blinding of outcome assessors. No studies made reference to behavior change theory in their design. Eight of the 12 studies investigated nursing documentation of pain assessment as the main outcome, with the majority reporting positive effects of education interventions on nursing pain assessment. Of the remaining studies, two reported mixed findings on patient self-report of pain scores as the key measure, one reported improvements in patient satisfaction with pain management after a nursing intervention, and one study found an increase in nurses' delivery of a relaxation treatment following an intervention. Improvements in design and evaluation of nursing education interventions are suggested, drawing on behavior change theory and emphasizing the relational, contextual, and emotionally demanding nature of nursing pain management in hospital settings. Crown Copyright © 2016. Published by Elsevier Inc. All rights reserved.

CUILESS2016: a clinical corpus applying compositional normalization of text mentions.

PubMed

Osborne, John D; Neu, Matthew B; Danila, Maria I; Solorio, Thamar; Bethard, Steven J

2018-01-10

Traditionally text mention normalization corpora have normalized concepts to single ontology identifiers ("pre-coordinated concepts"). Less frequently, normalization corpora have used concepts with multiple identifiers ("post-coordinated concepts") but the additional identifiers have been restricted to a defined set of relationships to the core concept. This approach limits the ability of the normalization process to express semantic meaning. We generated a freely available corpus using post-coordinated concepts without a defined set of relationships that we term "compositional concepts" to evaluate their use in clinical text. We annotated 5397 disorder mentions from the ShARe corpus to SNOMED CT that were previously normalized as "CUI-less" in the "SemEval-2015 Task 14" shared task because they lacked a pre-coordinated mapping. Unlike the previous normalization method, we do not restrict concept mappings to a particular set of the Unified Medical Language System (UMLS) semantic types and allow normalization to occur to multiple UMLS Concept Unique Identifiers (CUIs). We computed annotator agreement and assessed semantic coverage with this method. We generated the largest clinical text normalization corpus to date with mappings to multiple identifiers and made it freely available. All but 8 of the 5397 disorder mentions were normalized using this methodology. Annotator agreement ranged from 52.4% using the strictest metric (exact matching) to 78.2% using a hierarchical agreement that measures the overlap of shared ancestral nodes. Our results provide evidence that compositional concepts can increase semantic coverage in clinical text. To our knowledge we provide the first freely available corpus of compositional concept annotation in clinical text.

Strategies for Conducting Adolescent Health Research in the Clinical Setting: The Mount Sinai Adolescent Health Center HPV Experience

PubMed Central

Braun-Courville, Debra K.; Schlecht, Nicolas F.; Burk, Robert D.; Strickler, Howard D.; Rojas, Mary; Lorde-Rollins, Elizabeth; Nucci-Sack, Anne; Hollman, Dominic; Linares, L. Oriana; Diaz, Angela

2013-01-01

Background Clinical research with adolescents can be challenging due to issues of informed consent, parental involvement, institutional review board requirements, and adolescent psychosocial development. This presents a dilemma, particularly in the area of sexual health research, as adolescents are disproportionately affected by sexually transmitted infections such as human papillomavirus (HPV). To successfully conduct adolescent research in the clinical setting, one requires an awareness of state statutes regarding adolescent confidentiality and consent for medical care, and a close partnership with the IRB. Case Study In 2007, the Mount Sinai Adolescent Health Center (MSAHC) in collaboration with the Albert Einstein College of Medicine developed a longitudinal research study to examine the natural history of oral, cervical, and anal HPV in an adolescent female population engaged in high-risk sexual behaviors. We use this research project as a case study to explore the ethical, methodological, and clinical issues related to conducting adolescent health research. Summary and Conclusions Several strategies were identified to promote adolescent study participation, including: (1) building a research team that is motivated to work with adolescents; (2) combining research and patient care visits to avoid duplication of services; and (3) establishing a personalized communication network with participants. Using these methods, adolescent sexual health research can successfully be integrated into the clinical setting. While retaining a prospective cohort of adolescents has its challenges, a persistent and multi-disciplinary approach can help improve recruitment, sustain participation, and acquire critical data that will lead to improved healthcare knowledge applicable to understudied populations of adolescents. PMID:24332677

Engineering Concepts in Stem Cell Research.

PubMed

Narayanan, Karthikeyan; Mishra, Sachin; Singh, Satnam; Pei, Ming; Gulyas, Balazs; Padmanabhan, Parasuraman

2017-12-01

The field of regenerative medicine integrates advancements made in stem cells, molecular biology, engineering, and clinical methodologies. Stem cells serve as a fundamental ingredient for therapeutic application in regenerative medicine. Apart from stem cells, engineering concepts have equally contributed to the success of stem cell based applications in improving human health. The purpose of various engineering methodologies is to develop regenerative and preventive medicine to combat various diseases and deformities. Explosion of stem cell discoveries and their implementation in clinical setting warrants new engineering concepts and new biomaterials. Biomaterials, microfluidics, and nanotechnology are the major engineering concepts used for the implementation of stem cells in regenerative medicine. Many of these engineering technologies target the specific niche of the cell for better functional capability. Controlling the niche is the key for various developmental activities leading to organogenesis and tissue homeostasis. Biomimetic understanding not only helped to improve the design of the matrices or scaffolds by incorporating suitable biological and physical components, but also ultimately aided adoption of designs that helped these materials/devices have better function. Adoption of engineering concepts in stem cell research improved overall achievement, however, several important issues such as long-term effects with respect to systems biology needs to be addressed. Here, in this review the authors will highlight some interesting breakthroughs in stem cell biology that use engineering methodologies. © 2017 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

A novel approach for estimating ingested dose associated with paracetamol overdose

PubMed Central

Zurlinden, Todd J.; Heard, Kennon

2015-01-01

Aim In cases of paracetamol (acetaminophen, APAP) overdose, an accurate estimate of tissue‐specific paracetamol pharmacokinetics (PK) and ingested dose can offer health care providers important information for the individualized treatment and follow‐up of affected patients. Here a novel methodology is presented to make such estimates using a standard serum paracetamol measurement and a computational framework. Methods The core component of the computational framework was a physiologically‐based pharmacokinetic (PBPK) model developed and evaluated using an extensive set of human PK data. Bayesian inference was used for parameter and dose estimation, allowing the incorporation of inter‐study variability, and facilitating the calculation of uncertainty in model outputs. Results Simulations of paracetamol time course concentrations in the blood were in close agreement with experimental data under a wide range of dosing conditions. Also, predictions of administered dose showed good agreement with a large collection of clinical and emergency setting PK data over a broad dose range. In addition to dose estimation, the platform was applied for the determination of optimal blood sampling times for dose reconstruction and quantitation of the potential role of paracetamol conjugate measurement on dose estimation. Conclusions Current therapies for paracetamol overdose rely on a generic methodology involving the use of a clinical nomogram. By using the computational framework developed in this study, serum sample data, and the individual patient's anthropometric and physiological information, personalized serum and liver pharmacokinetic profiles and dose estimate could be generated to help inform an individualized overdose treatment and follow‐up plan. PMID:26441245

A novel approach for estimating ingested dose associated with paracetamol overdose.

PubMed

Zurlinden, Todd J; Heard, Kennon; Reisfeld, Brad

2016-04-01

In cases of paracetamol (acetaminophen, APAP) overdose, an accurate estimate of tissue-specific paracetamol pharmacokinetics (PK) and ingested dose can offer health care providers important information for the individualized treatment and follow-up of affected patients. Here a novel methodology is presented to make such estimates using a standard serum paracetamol measurement and a computational framework. The core component of the computational framework was a physiologically-based pharmacokinetic (PBPK) model developed and evaluated using an extensive set of human PK data. Bayesian inference was used for parameter and dose estimation, allowing the incorporation of inter-study variability, and facilitating the calculation of uncertainty in model outputs. Simulations of paracetamol time course concentrations in the blood were in close agreement with experimental data under a wide range of dosing conditions. Also, predictions of administered dose showed good agreement with a large collection of clinical and emergency setting PK data over a broad dose range. In addition to dose estimation, the platform was applied for the determination of optimal blood sampling times for dose reconstruction and quantitation of the potential role of paracetamol conjugate measurement on dose estimation. Current therapies for paracetamol overdose rely on a generic methodology involving the use of a clinical nomogram. By using the computational framework developed in this study, serum sample data, and the individual patient's anthropometric and physiological information, personalized serum and liver pharmacokinetic profiles and dose estimate could be generated to help inform an individualized overdose treatment and follow-up plan. © 2015 The British Pharmacological Society.

Application of process improvement principles to increase the frequency of complete airway management documentation.

PubMed

McCarty, L Kelsey; Saddawi-Konefka, Daniel; Gargan, Lauren M; Driscoll, William D; Walsh, John L; Peterfreund, Robert A

2014-12-01

Process improvement in healthcare delivery settings can be difficult, even when there is consensus among clinicians about a clinical practice or desired outcome. Airway management is a medical intervention fundamental to the delivery of anesthesia care. Like other medical interventions, a detailed description of the management methods should be documented. Despite this expectation, airway documentation is often insufficient. The authors hypothesized that formal adoption of process improvement methods could be used to increase the rate of "complete" airway management documentation. The authors defined a set of criteria as a local practice standard of "complete" airway management documentation. The authors then employed selected process improvement methodologies over 13 months in three iterative and escalating phases to increase the percentage of records with complete documentation. The criteria were applied retrospectively to determine the baseline frequency of complete records, and prospectively to measure the impact of process improvements efforts over the three phases of implementation. Immediately before the initial intervention, a retrospective review of 23,011 general anesthesia cases over 6 months showed that 13.2% of patient records included complete documentation. At the conclusion of the 13-month improvement effort, documentation improved to a completion rate of 91.6% (P<0.0001). During the subsequent 21 months, the completion rate was sustained at an average of 90.7% (SD, 0.9%) across 82,571 general anesthetic records. Systematic application of process improvement methodologies can improve airway documentation and may be similarly effective in improving other areas of anesthesia clinical practice.

Multiple Score Comparison: a network meta-analysis approach to comparison and external validation of prognostic scores.

PubMed

Haile, Sarah R; Guerra, Beniamino; Soriano, Joan B; Puhan, Milo A

2017-12-21

Prediction models and prognostic scores have been increasingly popular in both clinical practice and clinical research settings, for example to aid in risk-based decision making or control for confounding. In many medical fields, a large number of prognostic scores are available, but practitioners may find it difficult to choose between them due to lack of external validation as well as lack of comparisons between them. Borrowing methodology from network meta-analysis, we describe an approach to Multiple Score Comparison meta-analysis (MSC) which permits concurrent external validation and comparisons of prognostic scores using individual patient data (IPD) arising from a large-scale international collaboration. We describe the challenges in adapting network meta-analysis to the MSC setting, for instance the need to explicitly include correlations between the scores on a cohort level, and how to deal with many multi-score studies. We propose first using IPD to make cohort-level aggregate discrimination or calibration scores, comparing all to a common comparator. Then, standard network meta-analysis techniques can be applied, taking care to consider correlation structures in cohorts with multiple scores. Transitivity, consistency and heterogeneity are also examined. We provide a clinical application, comparing prognostic scores for 3-year mortality in patients with chronic obstructive pulmonary disease using data from a large-scale collaborative initiative. We focus on the discriminative properties of the prognostic scores. Our results show clear differences in performance, with ADO and eBODE showing higher discrimination with respect to mortality than other considered scores. The assumptions of transitivity and local and global consistency were not violated. Heterogeneity was small. We applied a network meta-analytic methodology to externally validate and concurrently compare the prognostic properties of clinical scores. Our large-scale external validation indicates that the scores with the best discriminative properties to predict 3 year mortality in patients with COPD are ADO and eBODE.

Current-reported outcome domains in studies of adults with a focus on the treatment of tinnitus: protocol for a systematic review

PubMed Central

Hall, Deborah A; Szczepek, Agnieszka J; Kennedy, Veronica; Haider, Haúla

2015-01-01

Introduction In Europe alone, over 70 million people experience tinnitus. Despite its considerable socioeconomic relevance, progress in developing successful treatments has been limited. Clinical effectiveness is judged according to change in primary outcome measures, but because tinnitus is a subjective condition, the definition of outcomes is challenging and it remains unclear which distinct aspects of tinnitus (ie, ‘domains’) are most relevant for assessment. The development of a minimum outcome reporting standard would go a long way towards addressing these problems. In 2006, a consensus meeting recommended using 1 of 4 questionnaires for tinnitus severity as an outcome in clinical trials, in part because of availability in different language translations. Our initiative takes an approach motivated by clinimetrics, first by determining what to measure before seeking to determine how to measure it. Agreeing on the domains that contribute to tinnitus severity (ie, ‘what’) is the first step towards achieving a minimum outcome reporting standard for tinnitus that has been reached via a methodologically rigorous and transparent process. Methods and analysis Deciding what should be the core set of outcomes requires a great deal of discussion and so lends itself well to international effort. This protocol lays out the first-step methodology in defining a Core Domain Set for clinical trials of tinnitus by establishing existing knowledge and practice with respect to which outcome domains have been measured and which instruments used in recent registered and published clinical trials. Ethics and dissemination No ethical issues are foreseen. Findings will be reported at national and international ear, nose and throat (ENT) and audiology conferences and in a peer-reviewed journal, using PRISMA (Preferred Reporting Items for Systematic reviews and Meta-analysis) guidelines. Trial registration number The systematic review protocol is registered on PROSPERO (International Prospective Register of Systematic Reviews): CRD42015017525. PMID:26560061

Current-reported outcome domains in studies of adults with a focus on the treatment of tinnitus: protocol for a systematic review.

PubMed

Hall, Deborah A; Szczepek, Agnieszka J; Kennedy, Veronica; Haider, Haúla

2015-11-11

In Europe alone, over 70 million people experience tinnitus. Despite its considerable socioeconomic relevance, progress in developing successful treatments has been limited. Clinical effectiveness is judged according to change in primary outcome measures, but because tinnitus is a subjective condition, the definition of outcomes is challenging and it remains unclear which distinct aspects of tinnitus (ie, 'domains') are most relevant for assessment. The development of a minimum outcome reporting standard would go a long way towards addressing these problems. In 2006, a consensus meeting recommended using 1 of 4 questionnaires for tinnitus severity as an outcome in clinical trials, in part because of availability in different language translations. Our initiative takes an approach motivated by clinimetrics, first by determining what to measure before seeking to determine how to measure it. Agreeing on the domains that contribute to tinnitus severity (ie, 'what') is the first step towards achieving a minimum outcome reporting standard for tinnitus that has been reached via a methodologically rigorous and transparent process. Deciding what should be the core set of outcomes requires a great deal of discussion and so lends itself well to international effort. This protocol lays out the first-step methodology in defining a Core Domain Set for clinical trials of tinnitus by establishing existing knowledge and practice with respect to which outcome domains have been measured and which instruments used in recent registered and published clinical trials. No ethical issues are foreseen. Findings will be reported at national and international ear, nose and throat (ENT) and audiology conferences and in a peer-reviewed journal, using PRISMA (Preferred Reporting Items for Systematic reviews and Meta-analysis) guidelines. The systematic review protocol is registered on PROSPERO (International Prospective Register of Systematic Reviews): CRD42015017525. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

[Progress in methodological characteristics of clinical practice guideline for osteoarthritis].

PubMed

Xing, D; Wang, B; Lin, J H

2017-06-01

At present, several clinical practice guidelines for the treatment of osteoarthritis have been developed by institutes or societies. The ultimate purpose of developing clinical practice guidelines is to formulate the process in the treatment of osteoarthritis effectively. However, the methodologies used in developing clinical practice guidelines may place an influence on the transformation and application of that in treating osteoarthritis. The present study summarized the methodological features of individual clinical practice guideline and presented the tools for quality evaluation of clinical practice guideline. The limitations of current osteoarthritis guidelines of China are also indicated. The review article might help relevant institutions improve the quality in developing guide and clinical transformation.

CONSIDER - Core Outcome Set in IAD Research: study protocol for establishing a core set of outcomes and measurements in incontinence-associated dermatitis research.

PubMed

Van den Bussche, Karen; De Meyer, Dorien; Van Damme, Nele; Kottner, Jan; Beeckman, Dimitri

2017-10-01

This study protocol describes the methodology for the development of a core set of outcomes and a core set of measurements for incontinence-associated dermatitis. Incontinence is a widespread disorder with an important impact on quality of life. One of the most common complications is incontinence-associated dermatitis, resulting from chemical and physical irritation of the skin barrier, triggering inflammation and skin damage. Managing incontinence-associated dermatitis is an important challenge for nurses. Several interventions have been assessed in clinical trials, but heterogeneity in study outcomes complicates the comparability and standardization. To overcome this challenge, the development of a core outcome set, a minimum set of outcomes and measurements to be assessed in clinical research, is needed. A project team, International Steering Committee and panelists will be involved to guide the development of the core outcome set. The framework of the Harmonizing Outcomes Measures for Eczema roadmap endorsed by Cochrane Skin Group Core Outcomes Set Initiative, is used to inform the project design. A systematic literature review, interviews to integrate the patients' perspective and a consensus study with healthcare researchers and providers using the Delphi procedure will be performed. The project was approved by the Ethics review Committee (April 2016). This is the first project that will identify a core outcome set of outcomes and measurements for incontinence-associated dermatitis research. A core outcome set will reduce possible reporting bias, allow results comparisons and statistical pooling across trials and strengthen evidence-based practice and decision-making. This project has been registered in the Core Outcome Measures in Effectiveness Trials (COMET) database and is part of the Cochrane Skin Group Core Outcomes Set Initiative (CSG-COUSIN). © 2016 John Wiley & Sons Ltd.

Standardized evaluation of algorithms for computer-aided diagnosis of dementia based on structural MRI: the CADDementia challenge.

PubMed

Bron, Esther E; Smits, Marion; van der Flier, Wiesje M; Vrenken, Hugo; Barkhof, Frederik; Scheltens, Philip; Papma, Janne M; Steketee, Rebecca M E; Méndez Orellana, Carolina; Meijboom, Rozanna; Pinto, Madalena; Meireles, Joana R; Garrett, Carolina; Bastos-Leite, António J; Abdulkadir, Ahmed; Ronneberger, Olaf; Amoroso, Nicola; Bellotti, Roberto; Cárdenas-Peña, David; Álvarez-Meza, Andrés M; Dolph, Chester V; Iftekharuddin, Khan M; Eskildsen, Simon F; Coupé, Pierrick; Fonov, Vladimir S; Franke, Katja; Gaser, Christian; Ledig, Christian; Guerrero, Ricardo; Tong, Tong; Gray, Katherine R; Moradi, Elaheh; Tohka, Jussi; Routier, Alexandre; Durrleman, Stanley; Sarica, Alessia; Di Fatta, Giuseppe; Sensi, Francesco; Chincarini, Andrea; Smith, Garry M; Stoyanov, Zhivko V; Sørensen, Lauge; Nielsen, Mads; Tangaro, Sabina; Inglese, Paolo; Wachinger, Christian; Reuter, Martin; van Swieten, John C; Niessen, Wiro J; Klein, Stefan

2015-05-01

Algorithms for computer-aided diagnosis of dementia based on structural MRI have demonstrated high performance in the literature, but are difficult to compare as different data sets and methodology were used for evaluation. In addition, it is unclear how the algorithms would perform on previously unseen data, and thus, how they would perform in clinical practice when there is no real opportunity to adapt the algorithm to the data at hand. To address these comparability, generalizability and clinical applicability issues, we organized a grand challenge that aimed to objectively compare algorithms based on a clinically representative multi-center data set. Using clinical practice as the starting point, the goal was to reproduce the clinical diagnosis. Therefore, we evaluated algorithms for multi-class classification of three diagnostic groups: patients with probable Alzheimer's disease, patients with mild cognitive impairment and healthy controls. The diagnosis based on clinical criteria was used as reference standard, as it was the best available reference despite its known limitations. For evaluation, a previously unseen test set was used consisting of 354 T1-weighted MRI scans with the diagnoses blinded. Fifteen research teams participated with a total of 29 algorithms. The algorithms were trained on a small training set (n=30) and optionally on data from other sources (e.g., the Alzheimer's Disease Neuroimaging Initiative, the Australian Imaging Biomarkers and Lifestyle flagship study of aging). The best performing algorithm yielded an accuracy of 63.0% and an area under the receiver-operating-characteristic curve (AUC) of 78.8%. In general, the best performances were achieved using feature extraction based on voxel-based morphometry or a combination of features that included volume, cortical thickness, shape and intensity. The challenge is open for new submissions via the web-based framework: http://caddementia.grand-challenge.org. Copyright © 2015 Elsevier Inc. All rights reserved.

Predictive Modeling of Cardiac Ischemia

NASA Technical Reports Server (NTRS)

Anderson, Gary T.

1996-01-01

The goal of the Contextual Alarms Management System (CALMS) project is to develop sophisticated models to predict the onset of clinical cardiac ischemia before it occurs. The system will continuously monitor cardiac patients and set off an alarm when they appear about to suffer an ischemic episode. The models take as inputs information from patient history and combine it with continuously updated information extracted from blood pressure, oxygen saturation and ECG lines. Expert system, statistical, neural network and rough set methodologies are then used to forecast the onset of clinical ischemia before it transpires, thus allowing early intervention aimed at preventing morbid complications from occurring. The models will differ from previous attempts by including combinations of continuous and discrete inputs. A commercial medical instrumentation and software company has invested funds in the project with a goal of commercialization of the technology. The end product will be a system that analyzes physiologic parameters and produces an alarm when myocardial ischemia is present. If proven feasible, a CALMS-based system will be added to existing heart monitoring hardware.

Performance evaluation of automated segmentation software on optical coherence tomography volume data

PubMed Central

Tian, Jing; Varga, Boglarka; Tatrai, Erika; Fanni, Palya; Somfai, Gabor Mark; Smiddy, William E.

2016-01-01

Over the past two decades a significant number of OCT segmentation approaches have been proposed in the literature. Each methodology has been conceived for and/or evaluated using specific datasets that do not reflect the complexities of the majority of widely available retinal features observed in clinical settings. In addition, there does not exist an appropriate OCT dataset with ground truth that reflects the realities of everyday retinal features observed in clinical settings. While the need for unbiased performance evaluation of automated segmentation algorithms is obvious, the validation process of segmentation algorithms have been usually performed by comparing with manual labelings from each study and there has been a lack of common ground truth. Therefore, a performance comparison of different algorithms using the same ground truth has never been performed. This paper reviews research-oriented tools for automated segmentation of the retinal tissue on OCT images. It also evaluates and compares the performance of these software tools with a common ground truth. PMID:27159849

On assessing surrogacy in a single trial setting using a semi-competing risks paradigm

PubMed Central

Ghosh, Debashis

2009-01-01

Summary There has been a recent emphasis on the identification of biomarkers and other biologic measures that may be potentially used as surrogate endpoints in clinical trials. We focus on the setting of data from a single clinical trial. In this paper, we consider a framework in which the surrogate must occur before the true endpoint. This suggests viewing the surrogate and true endpoints as semi-competing risks data; this approach is new to the literature on surrogate endpoints and leads to an asymmetrical treatment of the surrogate and true endpoints. However, such a data structure also conceptually complicates many of the previously considered measures of surrogacy in the literature. We propose novel estimation and inferential procedures for the relative effect and adjusted association quantities proposed by Buyse and Molenberghs (1998, Biometrics, 1014 – 1029). The proposed methodology is illustrated with application to simulated data, as well as to data from a leukemia study. PMID:18759839

Determination of Isavuconazole Susceptibility of Aspergillus and Candida Species by the EUCAST Method

PubMed Central

Howard, Susan J.; Lass-Flörl, Cornelia; Cuenca-Estrella, Manuel; Gomez-Lopez, Alicia

2013-01-01

Isavuconazole is a novel expanded-spectrum triazole, which has recently been approved by the FDA as an orphan drug to treat invasive aspergillosis and is currently being studied in phase III clinical trials for invasive candidiasis. The susceptibility of relatively few clinical isolates has been reported. In this study, the isavuconazole susceptibilities of 1,237 Aspergillus and 2,010 Candida geographically diverse clinical isolates were determined by EUCAST methodology at four European mycology laboratories, producing the largest multicenter data set thus far for this compound. In addition, a blinded collection of 30 cyp51A mutant Aspergillus fumigatus clinical isolates and 10 wild-type isolates was tested. From these two data sets, the following preliminary epidemiological cutoff (ECOFF) values were suggested: 2 mg/liter for Aspergillus fumigatus, Aspergillus terreus, and Aspergillus flavus; 4 mg/liter for Aspergillus niger; 0.25 mg/liter for Aspergillus nidulans; and 0.03 mg/liter for Candida albicans, Candida parapsilosis, and Candida tropicalis. Unfortunately, ECOFFs could not be determined for Candida glabrata or Candida krusei due to an unexplained interlaboratory MIC variation. For the blinded collection of A. fumigatus isolates, all MICs were ≤2 mg/liter for wild-type isolates. Differential isavuconazole MICs were observed for triazole-resistant A. fumigatus isolates with different cyp51A alterations: TR34/L98H mutants had elevated isavuconazole MICs, whereas isolates with G54 and M220 alterations had MICs in the wild-type range, suggesting that the efficacy of isavuconazole may not be affected by these alterations. This study will be an aid in interpreting isavuconazole MICs for clinical care and an important step in the future process of setting official clinical breakpoints. PMID:23959309

To pass or to fail? Understanding the factors considered by faculty in the clinical evaluation of nursing students.

PubMed

DeBrew, Jacqueline Kayler; Lewallen, Lynne Porter

2014-04-01

Making the decision to pass or to fail a nursing student is difficult for nurse educators, yet one that all educators face at some point in time. To make this decision, nurse educators draw from their past experiences and personal reflections on the situation. Using the qualitative method of critical incident technique, the authors asked educators to describe a time when they had to make a decision about whether to pass or fail a student in the clinical setting. The findings describe student and faculty factors important in clinical evaluation decisions, demonstrate the benefits of reflective practice to nurse educators, and support the utility of critical incident technique not only as research methodology, but also as a technique for reflective practice. Copyright © 2013 Elsevier Ltd. All rights reserved.

Update in Hospice and Palliative Care.

PubMed

Taylor, Richard A; Smith, Cardinale B; Coats, Heather; Gelfman, Laura P; Dionne-Odom, J Nicholas

2017-11-01

The objective of this update, presented at the 2017 Annual Assembly of the American Association of Palliative and Hospice Medicine (AAHPM) and the Hospice and Palliative Nurses Association (HPNA), is to identify, summarize, and critique a sampling of research from the prior year that has the potential for marked impact on hospice and palliative clinical practice. Eight reports of original research published between January 1, 2016 and December 31, 2016 were identified through a systematic PubMed search using the terms "hospice" and "palliative care," a hand search of 22 leading healthcare journals, and discussion with experts in the field. Candidate articles were ranked based on the study's methodological quality, appeal to a breadth of palliative care clinicians across different settings, and potential clinical practice impact. We summarize the eight articles with the highest ratings and give recommendations for clinical practice.

Methodological Issues in Design and Analysis of a Matched Case-Control Study of a Vaccine’s Effectiveness

PubMed Central

Niccolai, Linda M.; Ogden, Lorraine G.; Muehlenbein, Catherine E.; Dziura, James D.; Vázquez, Marietta; Shapiro, Eugene D.

2007-01-01

Objective Case-control studies of the effectiveness of a vaccine are useful to answer important questions, such as the effectiveness of a vaccine over time, that usually are not addressed by pre-licensure clinical trials of the vaccine’s efficacy. This report describes methodological issues related to design and analysis that were used to determine the effects of time since vaccination and age at the time of vaccination. Study Design and Setting A matched case-control study of the effectiveness of varicella vaccine. Results Sampling procedures and conditional logistic regression models including interaction terms are described. Conclusion Use of these methods will allow investigators to assess the effects of a wide range of variables, such as time since vaccination and age at the time of vaccination, on the effectiveness of a vaccine. PMID:17938054

Similarity-Based Recommendation of New Concepts to a Terminology

PubMed Central

Chandar, Praveen; Yaman, Anil; Hoxha, Julia; He, Zhe; Weng, Chunhua

2015-01-01

Terminologies can suffer from poor concept coverage due to delays in addition of new concepts. This study tests a similarity-based approach to recommending concepts from a text corpus to a terminology. Our approach involves extraction of candidate concepts from a given text corpus, which are represented using a set of features. The model learns the important features to characterize a concept and recommends new concepts to a terminology. Further, we propose a cost-effective evaluation methodology to estimate the effectiveness of terminology enrichment methods. To test our methodology, we use the clinical trial eligibility criteria free-text as an example text corpus to recommend concepts for SNOMED CT. We computed precision at various rank intervals to measure the performance of the methods. Results indicate that our automated algorithm is an effective method for concept recommendation. PMID:26958170

Taxonomy-Based Approaches to Quality Assurance of Ontologies

PubMed Central

Perl, Yehoshua; Ochs, Christopher

2017-01-01

Ontologies are important components of health information management systems. As such, the quality of their content is of paramount importance. It has been proven to be practical to develop quality assurance (QA) methodologies based on automated identification of sets of concepts expected to have higher likelihood of errors. Four kinds of such sets (called QA-sets) organized around the themes of complex and uncommonly modeled concepts are introduced. A survey of different methodologies based on these QA-sets and the results of applying them to various ontologies are presented. Overall, following these approaches leads to higher QA yields and better utilization of QA personnel. The formulation of additional QA-set methodologies will further enhance the suite of available ontology QA tools. PMID:29158885

Collaborative Initiative on Fetal Alcohol Spectrum Disorders: Methodology of Clinical Projects

PubMed Central

Mattson, Sarah N.; Foroud, Tatiana; Sowell, Elizabeth R.; Jones, Kenneth Lyons; Coles, Claire D.; Fagerlund, Åse; Autti-Rämö, Ilona; May, Philip A.; Adnams, Colleen M.; Konovalova, Valentina; Wetherill, Leah; Arenson, Andrew D.; Barnett, William K.; Riley, Edward P.

2009-01-01

The Collaborative Initiative on Fetal Alcohol Spectrum Disorders (CIFASD) was created in 2003 to further understanding of fetal alcohol spectrum disorders. Clinical and basic science projects collect data across multiple sites using standardized methodology. This paper describes the methodology being used by the clinical projects that pertain to assessment of children and adolescents. Domains being addressed are dysmorphology, neurobehavior, 3D facial imaging, and brain imaging. PMID:20036488

Use of Management Pathways or Algorithms in Children With Chronic Cough: CHEST Guideline and Expert Panel Report.

PubMed

Chang, Anne B; Oppenheimer, John J; Weinberger, Miles M; Rubin, Bruce K; Weir, Kelly; Grant, Cameron C; Irwin, Richard S

2017-04-01

Using management algorithms or pathways potentially improves clinical outcomes. We undertook systematic reviews to examine various aspects in the generic approach (use of cough algorithms and tests) to the management of chronic cough in children (aged ≤ 14 years) based on key questions (KQs) using the Population, Intervention, Comparison, Outcome format. We used the CHEST Expert Cough Panel's protocol for the systematic reviews and the American College of Chest Physicians (CHEST) methodological guidelines and Grading of Recommendations Assessment, Development and Evaluation framework. Data from the systematic reviews in conjunction with patients' values and preferences and the clinical context were used to form recommendations. Delphi methodology was used to obtain the final grading. Combining data from systematic reviews addressing five KQs, we found high-quality evidence that a systematic approach to the management of chronic cough improves clinical outcomes. Although there was evidence from several pathways, the highest evidence was from the use of the CHEST approach. However, there was no or little evidence to address some of the KQs posed. Compared with the 2006 Cough Guidelines, there is now high-quality evidence that in children aged ≤ 14 years with chronic cough (> 4 weeks' duration), the use of cough management protocols (or algorithms) improves clinical outcomes, and cough management or testing algorithms should differ depending on the associated characteristics of the cough and clinical history. A chest radiograph and, when age appropriate, spirometry (pre- and post-β 2 agonist) should be undertaken. Other tests should not be routinely performed and undertaken in accordance with the clinical setting and the child's clinical symptoms and signs (eg, tests for tuberculosis when the child has been exposed). Copyright © 2017 American College of Chest Physicians. All rights reserved.

A standard based approach for biomedical knowledge representation.

PubMed

Farkash, Ariel; Neuvirth, Hani; Goldschmidt, Yaara; Conti, Costanza; Rizzi, Federica; Bianchi, Stefano; Salvi, Erika; Cusi, Daniele; Shabo, Amnon

2011-01-01

The new generation of health information standards, where the syntax and semantics of the content is explicitly formalized, allows for interoperability in healthcare scenarios and analysis in clinical research settings. Studies involving clinical and genomic data include accumulating knowledge as relationships between genotypic and phenotypic information as well as associations within the genomic and clinical worlds. Some involve analysis results targeted at a specific disease; others are of a predictive nature specific to a patient and may be used by decision support applications. Representing knowledge is as important as representing data since data is more useful when coupled with relevant knowledge. Any further analysis and cross-research collaboration would benefit from persisting knowledge and data in a unified way. This paper describes a methodology used in Hypergenes, an EC FP7 project targeting Essential Hypertension, which captures data and knowledge using standards such as HL7 CDA and Clinical Genomics, aligned with the CEN EHR 13606 specification. We demonstrate the benefits of such an approach for clinical research as well as in healthcare oriented scenarios.

Health level 7 development framework for medication administration.

PubMed

Kim, Hwa Sun; Cho, Hune

2009-01-01

We propose the creation of a standard data model for medication administration activities through the development of a clinical document architecture using the Health Level 7 Development Framework process based on an object-oriented analysis and the development method of Health Level 7 Version 3. Medication administration is the most common activity performed by clinical professionals in healthcare settings. A standardized information model and structured hospital information system are necessary to achieve evidence-based clinical activities. A virtual scenario is used to demonstrate the proposed method of administering medication. We used the Health Level 7 Development Framework and other tools to create the clinical document architecture, which allowed us to illustrate each step of the Health Level 7 Development Framework in the administration of medication. We generated an information model of the medication administration process as one clinical activity. It should become a fundamental conceptual model for understanding international-standard methodology by healthcare professionals and nursing practitioners with the objective of modeling healthcare information systems.

Mixture-based gatekeeping procedures in adaptive clinical trials.

PubMed

Kordzakhia, George; Dmitrienko, Alex; Ishida, Eiji

2018-01-01

Clinical trials with data-driven decision rules often pursue multiple clinical objectives such as the evaluation of several endpoints or several doses of an experimental treatment. These complex analysis strategies give rise to "multivariate" multiplicity problems with several components or sources of multiplicity. A general framework for defining gatekeeping procedures in clinical trials with adaptive multistage designs is proposed in this paper. The mixture method is applied to build a gatekeeping procedure at each stage and inferences at each decision point (interim or final analysis) are performed using the combination function approach. An advantage of utilizing the mixture method is that it enables powerful gatekeeping procedures applicable to a broad class of settings with complex logical relationships among the hypotheses of interest. Further, the combination function approach supports flexible data-driven decisions such as a decision to increase the sample size or remove a treatment arm. The paper concludes with a clinical trial example that illustrates the methodology by applying it to develop an adaptive two-stage design with a mixture-based gatekeeping procedure.

Methodological issues associated with preclinical drug development and increased placebo effects in schizophrenia clinical trials.

PubMed

Brown, Matt A; Bishnoi, Ram J; Dholakia, Sara; Velligan, Dawn I

2016-01-20

Recent failures to detect efficacy in clinical trials investigating pharmacological treatments for schizophrenia raise concerns regarding the potential contribution of methodological shortcomings to this research. This review provides an examination of two key methodological issues currently suspected of playing a role in hampering schizophrenia drug development; 1) limitations on the translational utility of preclinical development models, and 2) methodological challenges posed by increased placebo effects. Recommendations for strategies to address these methodological issues are addressed.

Experience-based co-design in an adult psychological therapies service.

PubMed

Cooper, Kate; Gillmore, Chris; Hogg, Lorna

2016-01-01

Experience-based co-design (EBCD) is a methodology for service improvement and development, which puts service-user voices at the heart of improving health services. The aim of this paper was to implement the EBCD methodology in a mental health setting, and to investigate the challenges which arise during this process. In order to achieve this, a modified version of the EBCD methodology was undertaken, which involved listening to the experiences of the people who work in and use the mental health setting and sharing these experiences with the people who could effect change within the service, through collaborative work between service-users, staff and managers. EBCD was implemented within the mental health setting and was well received by service-users, staff and stakeholders. A number of modifications were necessary in this setting, for example high levels of support available to participants. It was concluded that EBCD is a suitable methodology for service improvement in mental health settings.

The use of electronic games in therapy: a review with clinical implications.

PubMed

Horne-Moyer, H Lynn; Moyer, Brian H; Messer, Drew C; Messer, Elizabeth S

2014-12-01

Therapists and patients enjoy and benefit from interventions that use electronic games (EG) in health care and mental health settings, with a variety of diagnoses and therapeutic goals. We reviewed the use of electronic games designed specifically for a therapeutic purpose, electronic games for psychotherapy (EGP), also called serious games, and commercially produced games used as an adjunct to psychotherapy, electronic games for entertainment (EGE). Recent research on the benefits of EG in rehabilitation settings, EGP, and EGE indicates that electronic methods are often equivalent to more traditional treatments and may be more enjoyable or acceptable, at least to some consumers. Methodological concerns include the lack of randomized controlled trials (RCT) for many applications. Suggestions are offered for using EG in therapeutic practice.

Designing an activity-based costing model for a non-admitted prisoner healthcare setting.

PubMed

Cai, Xiao; Moore, Elizabeth; McNamara, Martin

2013-09-01

To design and deliver an activity-based costing model within a non-admitted prisoner healthcare setting. Key phases from the NSW Health clinical redesign methodology were utilised: diagnostic, solution design and implementation. The diagnostic phase utilised a range of strategies to identify issues requiring attention in the development of the costing model. The solution design phase conceptualised distinct 'building blocks' of activity and cost based on the speciality of clinicians providing care. These building blocks enabled the classification of activity and comparisons of costs between similar facilities. The implementation phase validated the model. The project generated an activity-based costing model based on actual activity performed, gained acceptability among clinicians and managers, and provided the basis for ongoing efficiency and benchmarking efforts.

Classification of physical activities based on body-segments coordination.

PubMed

Fradet, Laetitia; Marin, Frederic

2016-09-01

Numerous innovations based on connected objects and physical activity (PA) monitoring have been proposed. However, recognition of PAs requires robust algorithm and methodology. The current study presents an innovative approach for PA recognition. It is based on the heuristic definition of postures and the use of body-segments coordination obtained through external sensors. The first part of this study presents the methodology required to define the set of accelerations which is the most appropriate to represent the particular body-segments coordination involved in the chosen PAs (here walking, running, and cycling). For that purpose, subjects of different ages and heterogeneous physical conditions walked, ran, cycled, and performed daily activities at different paces. From the 3D motion capture, vertical and horizontal accelerations of 8 anatomical landmarks representative of the body were computed. Then, the 680 combinations from up to 3 accelerations were compared to identify the most appropriate set of acceleration to discriminate the PAs in terms of body segment coordinations. The discrimination was based on the maximal Hausdorff Distance obtained between the different set of accelerations. The vertical accelerations of both knees demonstrated the best PAs discrimination. The second step was the proof of concept, implementing the proposed algorithm to classify PAs of new group of subjects. The originality of the proposed algorithm is the possibility to use the subject's specific measures as reference data. With the proposed algorithm, 94% of the trials were correctly classified. In conclusion, our study proposed a flexible and extendable methodology. At the current stage, the algorithm has been shown to be valid for heterogeneous subjects, which suggests that it could be deployed in clinical or health-related applications regardless of the subjects' physical abilities or characteristics. Copyright © 2016 Elsevier Ltd. All rights reserved.

Methodology in diagnostic laboratory test research in clinical chemistry and clinical chemistry and laboratory medicine.

PubMed

Lumbreras-Lacarra, Blanca; Ramos-Rincón, José Manuel; Hernández-Aguado, Ildefonso

2004-03-01

The application of epidemiologic principles to clinical diagnosis has been less developed than in other clinical areas. Knowledge of the main flaws affecting diagnostic laboratory test research is the first step for improving its quality. We assessed the methodologic aspects of articles on laboratory tests. We included articles that estimated indexes of diagnostic accuracy (sensitivity and specificity) and were published in Clinical Chemistry or Clinical Chemistry and Laboratory Medicine in 1996, 2001, and 2002. Clinical Chemistry has paid special attention to this field of research since 1996 by publishing recommendations, checklists, and reviews. Articles were identified through electronic searches in Medline. The strategy combined the Mesh term "sensitivity and specificity" (exploded) with the text words "specificity", "false negative", and "accuracy". We examined adherence to seven methodologic criteria used in the study by Reid et al. (JAMA1995;274:645-51) of papers published in general medical journals. Three observers evaluated each article independently. Seventy-nine articles fulfilled the inclusion criteria. The percentage of studies that satisfied each criterion improved from 1996 to 2002. Substantial improvement was observed in reporting of the statistical uncertainty of indices of diagnostic accuracy, in criteria based on clinical information from the study population (spectrum composition), and in avoidance of workup bias. Analytical reproducibility was reported frequently (68%), whereas information about indeterminate results was rarely provided. The mean number of methodologic criteria satisfied showed a statistically significant increase over the 3 years in Clinical Chemistry but not in Clinical Chemistry and Laboratory Medicine. The methodologic quality of the articles on diagnostic test research published in Clinical Chemistry and Clinical Chemistry and Laboratory Medicine is comparable to the quality observed in the best general medical journals. The methodologic aspects that most need improvement are those linked to the clinical information of the populations studied. Editorial actions aimed to increase the quality of reporting of diagnostic studies could have a relevant positive effect, as shown by the improvement observed in Clinical Chemistry.

Developing an International Register of Clinical Prediction Rules for Use in Primary Care: A Descriptive Analysis

PubMed Central

Keogh, Claire; Wallace, Emma; O’Brien, Kirsty K.; Galvin, Rose; Smith, Susan M.; Lewis, Cliona; Cummins, Anthony; Cousins, Grainne; Dimitrov, Borislav D.; Fahey, Tom

2014-01-01

PURPOSE We describe the methodology used to create a register of clinical prediction rules relevant to primary care. We also summarize the rules included in the register according to various characteristics. METHODS To identify relevant articles, we searched the MEDLINE database (PubMed) for the years 1980 to 2009 and supplemented the results with searches of secondary sources (books on clinical prediction rules) and personal resources (eg, experts in the field). The rules described in relevant articles were classified according to their clinical domain, the stage of development, and the clinical setting in which they were studied. RESULTS Our search identified clinical prediction rules reported between 1965 and 2009. The largest share of rules (37.2%) were retrieved from PubMed. The number of published rules increased substantially over the study decades. We included 745 articles in the register; many contained more than 1 clinical prediction rule study (eg, both a derivation study and a validation study), resulting in 989 individual studies. In all, 434 unique rules had gone through derivation; however, only 54.8% had been validated and merely 2.8% had undergone analysis of their impact on either the process or outcome of clinical care. The rules most commonly pertained to cardiovascular disease, respiratory, and musculoskeletal conditions. They had most often been studied in the primary care or emergency department settings. CONCLUSIONS Many clinical prediction rules have been derived, but only about half have been validated and few have been assessed for clinical impact. This lack of thorough evaluation for many rules makes it difficult to retrieve and identify those that are ready for use at the point of patient care. We plan to develop an international web-based register of clinical prediction rules and computer-based clinical decision support systems. PMID:25024245

Combining Gene Signatures Improves Prediction of Breast Cancer Survival

PubMed Central

Zhao, Xi; Naume, Bjørn; Langerød, Anita; Frigessi, Arnoldo; Kristensen, Vessela N.; Børresen-Dale, Anne-Lise; Lingjærde, Ole Christian

2011-01-01

Background Several gene sets for prediction of breast cancer survival have been derived from whole-genome mRNA expression profiles. Here, we develop a statistical framework to explore whether combination of the information from such sets may improve prediction of recurrence and breast cancer specific death in early-stage breast cancers. Microarray data from two clinically similar cohorts of breast cancer patients are used as training (n = 123) and test set (n = 81), respectively. Gene sets from eleven previously published gene signatures are included in the study. Principal Findings To investigate the relationship between breast cancer survival and gene expression on a particular gene set, a Cox proportional hazards model is applied using partial likelihood regression with an L2 penalty to avoid overfitting and using cross-validation to determine the penalty weight. The fitted models are applied to an independent test set to obtain a predicted risk for each individual and each gene set. Hierarchical clustering of the test individuals on the basis of the vector of predicted risks results in two clusters with distinct clinical characteristics in terms of the distribution of molecular subtypes, ER, PR status, TP53 mutation status and histological grade category, and associated with significantly different survival probabilities (recurrence: p = 0.005; breast cancer death: p = 0.014). Finally, principal components analysis of the gene signatures is used to derive combined predictors used to fit a new Cox model. This model classifies test individuals into two risk groups with distinct survival characteristics (recurrence: p = 0.003; breast cancer death: p = 0.001). The latter classifier outperforms all the individual gene signatures, as well as Cox models based on traditional clinical parameters and the Adjuvant! Online for survival prediction. Conclusion Combining the predictive strength of multiple gene signatures improves prediction of breast cancer survival. The presented methodology is broadly applicable to breast cancer risk assessment using any new identified gene set. PMID:21423775

Optimization of the decision-making process for the selection of therapeutics to undergo clinical testing for spinal cord injury in the North American Clinical Trials Network.

PubMed

Guest, James; Harrop, James S; Aarabi, Bizhan; Grossman, Robert G; Fawcett, James W; Fehlings, Michael G; Tator, Charles H

2012-09-01

The North American Clinical Trials Network (NACTN) includes 9 clinical centers funded by the US Department of Defense and the Christopher Reeve Paralysis Foundation. Its purpose is to accelerate clinical testing of promising therapeutics in spinal cord injury (SCI) through the development of a robust interactive infrastructure. This structure includes key committees that serve to provide longitudinal guidance to the Network. These committees include the Executive, Data Management, and Neurological Outcome Assessments Committees, and the Therapeutic Selection Committee (TSC), which is the subject of this manuscript. The NACTN brings unique elements to the SCI field. The Network's stability is not restricted to a single clinical trial. Network members have diverse expertise and include experts in clinical care, clinical trial design and methodology, pharmacology, preclinical and clinical research, and advanced rehabilitation techniques. Frequent systematic communication is assigned a high value, as is democratic process, fairness and efficiency of decision making, and resource allocation. This article focuses on how decision making occurs within the TSC to rank alternative therapeutics according to 2 main variables: quality of the preclinical data set, and fit with the Network's aims and capabilities. This selection process is important because if the Network's resources are committed to a therapeutic, alternatives cannot be pursued. A proposed methodology includes a multicriteria decision analysis that uses a Multi-Attribute Global Inference of Quality matrix to quantify the process. To rank therapeutics, the TSC uses a series of consensus steps designed to reduce individual and group bias and limit subjectivity. Given the difficulties encountered by industry in completing clinical trials in SCI, stable collaborative not-for-profit consortia, such as the NACTN, may be essential to clinical progress in SCI. The evolution of the NACTN also offers substantial opportunity to refine decision making and group dynamics. Making the best possible decisions concerning therapeutics selection for trial testing is a cornerstone of the Network's function.

A Methodology for Anatomic Ultrasound Image Diagnostic Quality Assessment.

PubMed

Hemmsen, Martin Christian; Lange, Theis; Brandt, Andreas Hjelm; Nielsen, Michael Bachmann; Jensen, Jorgen Arendt

2017-01-01

This paper discusses the methods for the assessment of ultrasound image quality based on our experiences with evaluating new methods for anatomic imaging. It presents a methodology to ensure a fair assessment between competing imaging methods using clinically relevant evaluations. The methodology is valuable in the continuing process of method optimization and guided development of new imaging methods. It includes a three phased study plan covering from initial prototype development to clinical assessment. Recommendations to the clinical assessment protocol, software, and statistical analysis are presented. Earlier uses of the methodology has shown that it ensures validity of the assessment, as it separates the influences between developer, investigator, and assessor once a research protocol has been established. This separation reduces confounding influences on the result from the developer to properly reveal the clinical value. This paper exemplifies the methodology using recent studies of synthetic aperture sequential beamforming tissue harmonic imaging.

Identification of design features to enhance utilization and acceptance of systems for Internet-based decision support at the point of care.

PubMed Central

Gadd, C. S.; Baskaran, P.; Lobach, D. F.

1998-01-01

Extensive utilization of point-of-care decision support systems will be largely dependent on the development of user interaction capabilities that make them effective clinical tools in patient care settings. This research identified critical design features of point-of-care decision support systems that are preferred by physicians, through a multi-method formative evaluation of an evolving prototype of an Internet-based clinical decision support system. Clinicians used four versions of the system--each highlighting a different functionality. Surveys and qualitative evaluation methodologies assessed clinicians' perceptions regarding system usability and usefulness. Our analyses identified features that improve perceived usability, such as telegraphic representations of guideline-related information, facile navigation, and a forgiving, flexible interface. Users also preferred features that enhance usefulness and motivate use, such as an encounter documentation tool and the availability of physician instruction and patient education materials. In addition to identifying design features that are relevant to efforts to develop clinical systems for point-of-care decision support, this study demonstrates the value of combining quantitative and qualitative methods of formative evaluation with an iterative system development strategy to implement new information technology in complex clinical settings. Images Figure 1 PMID:9929188

Comparison of methodologic quality and study/report characteristics between quantitative clinical nursing and nursing education research articles.

PubMed

Schneider, Barbara St Pierre; Nicholas, Jennifer; Kurrus, Jeffrey E

2013-01-01

To compare the methodologic quality and study/report characteristics between quantitative clinical nursing and nursing education research articles. The methodologic quality of quantitative nursing education research needs to advance to a higher level. Clinical research can provide guidance for nursing education to reach this level. One hundred quantitative clinical research articles from-high impact journals published in 2007 and 37 education research articles from high impact journals published in 2006 to 2007 were chosen for analysis. Clinical articles had significantly higher quality scores than education articles in three domains: number of institutions studied, type of data, and outcomes. The findings indicate three ways in which nursing education researchers can strengthen the methodologic quality of their quantitative research. With this approach, greater funding may be secured for advancing the science of nursing education.

Predicting ground contact events for a continuum of gait types: An application of targeted machine learning using principal component analysis.

PubMed

Osis, Sean T; Hettinga, Blayne A; Ferber, Reed

2016-05-01

An ongoing challenge in the application of gait analysis to clinical settings is the standardized detection of temporal events, with unobtrusive and cost-effective equipment, for a wide range of gait types. The purpose of the current study was to investigate a targeted machine learning approach for the prediction of timing for foot strike (or initial contact) and toe-off, using only kinematics for walking, forefoot running, and heel-toe running. Data were categorized by gait type and split into a training set (∼30%) and a validation set (∼70%). A principal component analysis was performed, and separate linear models were trained and validated for foot strike and toe-off, using ground reaction force data as a gold-standard for event timing. Results indicate the model predicted both foot strike and toe-off timing to within 20ms of the gold-standard for more than 95% of cases in walking and running gaits. The machine learning approach continues to provide robust timing predictions for clinical use, and may offer a flexible methodology to handle new events and gait types. Copyright © 2016 Elsevier B.V. All rights reserved.

Getting the Picture and Changing the Picture: Visual Methodologies and Educational Research in South Africa

ERIC Educational Resources Information Center

Mitchell, Claudia

2008-01-01

At the risk of seeming to make exaggerated claims for visual methodologies, what I set out to do is lay bare some of the key elements of working with the visual as a set of methodologies and practices. In particular, I address educational research in South Africa at a time when questions of the social responsibility of the academic researcher…

76 FR 60720 - Wage Methodology for the Temporary Non-Agricultural Employment H-2B Program; Postponement of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-30

... wage determinations based on the new prevailing wage methodology set forth in the Wage Rule, as to the... comment, we published a Final Rule on August 1, 2011, which set the new effective date for the Wage Rule... date of the Wage Methodology for the Temporary Non- agricultural Employment H-2B Program Final Rule...

Structured prediction models for RNN based sequence labeling in clinical text.

PubMed

Jagannatha, Abhyuday N; Yu, Hong

2016-11-01

Sequence labeling is a widely used method for named entity recognition and information extraction from unstructured natural language data. In clinical domain one major application of sequence labeling involves extraction of medical entities such as medication, indication, and side-effects from Electronic Health Record narratives. Sequence labeling in this domain, presents its own set of challenges and objectives. In this work we experimented with various CRF based structured learning models with Recurrent Neural Networks. We extend the previously studied LSTM-CRF models with explicit modeling of pairwise potentials. We also propose an approximate version of skip-chain CRF inference with RNN potentials. We use these methodologies for structured prediction in order to improve the exact phrase detection of various medical entities.

Structured prediction models for RNN based sequence labeling in clinical text

PubMed Central

Jagannatha, Abhyuday N; Yu, Hong

2016-01-01

Sequence labeling is a widely used method for named entity recognition and information extraction from unstructured natural language data. In clinical domain one major application of sequence labeling involves extraction of medical entities such as medication, indication, and side-effects from Electronic Health Record narratives. Sequence labeling in this domain, presents its own set of challenges and objectives. In this work we experimented with various CRF based structured learning models with Recurrent Neural Networks. We extend the previously studied LSTM-CRF models with explicit modeling of pairwise potentials. We also propose an approximate version of skip-chain CRF inference with RNN potentials. We use these methodologies1 for structured prediction in order to improve the exact phrase detection of various medical entities. PMID:28004040

Feminist Methodologies and Engineering Education Research

ERIC Educational Resources Information Center

Beddoes, Kacey

2013-01-01

This paper introduces feminist methodologies in the context of engineering education research. It builds upon other recent methodology articles in engineering education journals and presents feminist research methodologies as a concrete engineering education setting in which to explore the connections between epistemology, methodology and theory.…

Complementary nonparametric analysis of covariance for logistic regression in a randomized clinical trial setting.

PubMed

Tangen, C M; Koch, G G

1999-03-01

In the randomized clinical trial setting, controlling for covariates is expected to produce variance reduction for the treatment parameter estimate and to adjust for random imbalances of covariates between the treatment groups. However, for the logistic regression model, variance reduction is not obviously obtained. This can lead to concerns about the assumptions of the logistic model. We introduce a complementary nonparametric method for covariate adjustment. It provides results that are usually compatible with expectations for analysis of covariance. The only assumptions required are based on randomization and sampling arguments. The resulting treatment parameter is a (unconditional) population average log-odds ratio that has been adjusted for random imbalance of covariates. Data from a randomized clinical trial are used to compare results from the traditional maximum likelihood logistic method with those from the nonparametric logistic method. We examine treatment parameter estimates, corresponding standard errors, and significance levels in models with and without covariate adjustment. In addition, we discuss differences between unconditional population average treatment parameters and conditional subpopulation average treatment parameters. Additional features of the nonparametric method, including stratified (multicenter) and multivariate (multivisit) analyses, are illustrated. Extensions of this methodology to the proportional odds model are also made.

Technical solutions for simultaneous MEG and SEEG recordings: towards routine clinical use.

PubMed

Badier, J M; Dubarry, A S; Gavaret, M; Chen, S; Trébuchon, A S; Marquis, P; Régis, J; Bartolomei, F; Bénar, C G; Carron, R

2017-09-21

The simultaneous recording of intracerebral EEG (stereotaxic EEG, SEEG) and magnetoencephalography (MEG) is a promising strategy that provides both local and global views on brain pathological activity. Yet, acquiring simultaneous signals poses difficult technical issues that hamper their use in clinical routine. Our objective was thus to develop a set of solutions for recording a high number of SEEG channels while preserving signal quality. We recorded data in a patient with drug resistant epilepsy during presurgical evaluation. We used dedicated insertion screws and optically insulated amplifiers. We recorded 137 SEEG contacts on 10 depth electrodes (5-15 contacts each) and 248 MEG channels (magnetometers). Signal quality was assessed by comparing the distribution of RMS values in different frequency bands to a reference set of MEG acquisitions. The quality of signals was excellent for both MEG and SEEG; for MEG, it was comparable to that of MEG signals without concurrent SEEG. Discharges involving several structures on SEEG were visible on MEG, whereas discharges limited in space were not seen at the surface. SEEG can now be recorded simultaneously with whole-head MEG in routine. This opens new avenues, both methodologically for understanding signals and improving signal processing methods, and clinically for future combined analyses.

Health care provider experiences in primary care memory clinics: a phenomenological study.

PubMed

Sheiban, Linda; Stolee, Paul; McAiney, Carrie; Boscart, Veronique

2018-05-19

There is a growing need for community-based services for persons with Alzheimer's disease and related dementias (ADRD). Memory clinic (MC) teams in primary care settings have been established to provide care to people with ADRD. To consider wider adoption of these MC teams, insight is needed into the experiences of practitioners working in these models. The purpose of the current study is to explore the experiences of health care providers (HCPs) who work in primary care Memory Clinic (MC) teams to provide care to persons with Alzheimer's disease and related dementias (ADRD). This study utilized a phenomenological methodology to explore experiences of 12 HCPs in two primary care MCs. Semi-structured interviews were completed with each HCP. Interviews were recorded and transcribed verbatim. Colaizzi's steps for analyzing phenomenological data was utilized by the authors. Three themes emerged from the analysis to describe HCP experiences: supporting patients and family members during ADRD diagnosis and treatment, working in a team setting, and personal and professional rewards of caring for people with ADRD and their family members. Findings provide insight into current practices in primary care MCs and on the motivation of HCPs working with persons with ADRD.

The interaction between research and practice: a pan-European approach to managing H.pylori infection in primary care.

PubMed

Hungin, A P

2000-08-01

The transposition of evidence into clinical care presents many challenges. New knowledge may be immediately translatable to the practice setting, with barriers to be overcome before implementation. The early guidelines on Helicobacter pylori management presented an overview but were not able to take into account local factors and health care traditions, such as the non-availability of tests and established primary-secondary care relationships. Primary care is a specific specialty across most of Europe, existing within different health care systems and clinical traditions. The creation of H. pylori management guidelines, aimed at European primary care but adaptable to local national circumstances, presented a challenge in methodology and formulation. The process exposed similarities but also tensions between differing health care systems, as well as variations in the conditions in which GPs practise. Clinical differences, such as varying ulcer prevalence and drug resistance rates, highlighted the importance of guidelines being adaptable. This paper analyses the European Society for Primary Care Gastroenterology process of pan-European primary care agreement towards H.pylori management and how diverse views, traditions and national settings were reconciled through an evidence-based approach.

Economic evaluations of clinical pharmacist interventions on hospital inpatients: a systematic review of recent literature.

PubMed

Gallagher, James; McCarthy, Suzanne; Byrne, Stephen

2014-12-01

Clinical and cost-effectiveness evidence are needed to justify the existence or extension of routine clinical pharmacy services in hospital settings. Previous reviews have indicated that clinical pharmacist interventions are likely to have a positive economic impact on hospital budgets but highlighted issues relating to the quality of studies. The primary aim of this review was to feature economic evaluations of clinical pharmacy services which targeted hospital inpatients. The review focused on the current cost-effectiveness status of different services, in addition to evaluating the quality of individual studies. Results of this systematic review were compared with cost-effectiveness and quality related findings of reviews which considered earlier time frames and alternative settings. A systematic review of the literature included a review of the following databases: Academic Search Complete, Cochrane Library, EconLit, Embase Elsevier, NHS Economic Evaluation Database and PubMed. Only studies with an economic assessment of a clinical pharmacy service provided in a hospital setting were included. Data relating to the cost-effectiveness was extracted from eligible studies. Methodologies employed and overall quality of the studies was also reviewed. A grading system was applied to determine the quality of studies. Consolidated Health Economic Evaluation Reporting Standards statement was employed to determine which aspects of a high quality health economic study were employed. Twenty studies were deemed eligible for inclusion. Overall, pharmacist interventions had a positive impact on hospital budgets. Only three studies (15 %) were deemed to be "good-quality" studies. No 'novel'clinical pharmacist intervention was identified during the course of this review. Clinical pharmacy interventions continue to provide cost savings. However, the standard of studies published has stagnated or even deteriorated in comparison with those included in previous reviews. Utilisation of published guidelines at initial stages of future studies may help improve the overall quality of studies.

Non-contact versus contact-based sensing methodologies for in-home upper arm robotic rehabilitation.

PubMed

Howard, Ayanna; Brooks, Douglas; Brown, Edward; Gebregiorgis, Adey; Chen, Yu-Ping

2013-06-01

In recent years, robot-assisted rehabilitation has gained momentum as a viable means for improving outcomes for therapeutic interventions. Such therapy experiences allow controlled and repeatable trials and quantitative evaluation of mobility metrics. Typically though these robotic devices have been focused on rehabilitation within a clinical setting. In these traditional robot-assisted rehabilitation studies, participants are required to perform goal-directed movements with the robot during a therapy session. This requires physical contact between the participant and the robot to enable precise control of the task, as well as a means to collect relevant performance data. On the other hand, non-contact means of robot interaction can provide a safe methodology for extracting the control data needed for in-home rehabilitation. As such, in this paper we discuss a contact and non-contact based method for upper-arm rehabilitation exercises that enables quantification of upper-arm movements. We evaluate our methodology on upper-arm abduction/adduction movements and discuss the advantages and limitations of each approach as applied to an in-home rehabilitation scenario.

[Methodological approach to the use of artificial neural networks for predicting results in medicine].

PubMed

Trujillano, Javier; March, Jaume; Sorribas, Albert

2004-01-01

In clinical practice, there is an increasing interest in obtaining adequate models of prediction. Within the possible available alternatives, the artificial neural networks (ANN) are progressively more used. In this review we first introduce the ANN methodology, describing the most common type of ANN, the Multilayer Perceptron trained with backpropagation algorithm (MLP). Then we compare the MLP with the Logistic Regression (LR). Finally, we show a practical scheme to make an application based on ANN by means of an example with actual data. The main advantage of the RN is its capacity to incorporate nonlinear effects and interactions between the variables of the model without need to include them a priori. As greater disadvantages, they show a difficult interpretation of their parameters and large empiricism in their process of construction and training. ANN are useful for the computation of probabilities of a given outcome based on a set of predicting variables. Furthermore, in some cases, they obtain better results than LR. Both methodologies, ANN and LR, are complementary and they help us to obtain more valid models.

Revitalization of clinical skills training at the University of the Western Cape.

PubMed

Jeggels, J D; Traut, A; Kwast, M

2010-06-01

Most educational institutions that offer health related qualifications make use of clinical skills laboratories. These spaces are generally used for the demonstration and assessment of clinical skills. The purpose of this paper is to share our experiences related to the revitalization of skills training by introducing the skills lab method at the School of Nursing (SoN), University of the Western Cape (UWC). To accommodate the contextual changes as a result of the restructuring of the higher education landscape in 2003, the clinical skills training programme at UWC had to be reviewed. With a dramatic increase in the student numbers and a reduction in hospital beds, the skills lab method provided students with an opportunity to develop clinical skills prior to their placement in real service settings. The design phase centred on adopting a skills training methodology that articulates with the case-based approach used by the SoN. Kolb's, experiential learning cycle provided the theoretical underpinning for the methodology. The planning phase was spent on the development of resources. Eight staff members were trained by our international higher education collaborators who also facilitated the training of clinical supervisors and simulated patients. The physical space had to be redesigned to accommodate audio visual and information technology to support the phases of the skills lab method. The implementation of the skills lab method was phased in from the first-year level. An interactive seminar held after the first year of implementation provided feedback from all the role players and was mostly positive. The results of introducing the skills lab method include: a move by students towards self-directed clinical skills development, clinical supervisors adopting the role of facilitators of learning and experiential clinical learning being based on, amongst others, the students' engagement with simulated patients. Finally, the recommendations relate to tailor-making clinical skills training by using various aspects of teaching and learning principles, i.e. case-based teaching, experiential learning and the skills lab method.

Criteria for quantitative and qualitative data integration: mixed-methods research methodology.

PubMed

Lee, Seonah; Smith, Carrol A M

2012-05-01

Many studies have emphasized the need and importance of a mixed-methods approach for evaluation of clinical information systems. However, those studies had no criteria to guide integration of multiple data sets. Integrating different data sets serves to actualize the paradigm that a mixed-methods approach argues; thus, we require criteria that provide the right direction to integrate quantitative and qualitative data. The first author used a set of criteria organized from a literature search for integration of multiple data sets from mixed-methods research. The purpose of this article was to reorganize the identified criteria. Through critical appraisal of the reasons for designing mixed-methods research, three criteria resulted: validation, complementarity, and discrepancy. In applying the criteria to empirical data of a previous mixed methods study, integration of quantitative and qualitative data was achieved in a systematic manner. It helped us obtain a better organized understanding of the results. The criteria of this article offer the potential to produce insightful analyses of mixed-methods evaluations of health information systems.

Design and methodological considerations of an effectiveness trial of a computer-assisted intervention: an example from the NIDA Clinical Trials Network.

PubMed

Campbell, Aimee N C; Nunes, Edward V; Miele, Gloria M; Matthews, Abigail; Polsky, Daniel; Ghitza, Udi E; Turrigiano, Eva; Bailey, Genie L; VanVeldhuisen, Paul; Chapdelaine, Rita; Froias, Autumn; Stitzer, Maxine L; Carroll, Kathleen M; Winhusen, Theresa; Clingerman, Sara; Perez, Livangelie; McClure, Erin; Goldman, Bruce; Crowell, A Rebecca

2012-03-01

Computer-assisted interventions hold the promise of minimizing two problems that are ubiquitous in substance abuse treatment: the lack of ready access to treatment and the challenges to providing empirically-supported treatments. Reviews of research on computer-assisted treatments for mental health and substance abuse report promising findings, but study quality and methodological limitations remain an issue. In addition, relatively few computer-assisted treatments have been tested among illicit substance users. This manuscript describes the methodological considerations of a multi-site effectiveness trial conducted within the National Institute on Drug Abuse's (NIDA's) National Drug Abuse Treatment Clinical Trials Network (CTN). The study is evaluating a web-based version of the Community Reinforcement Approach, in addition to prize-based contingency management, among 500 participants enrolled in 10 outpatient substance abuse treatment programs. Several potential effectiveness trial designs were considered and the rationale for the choice of design in this study is described. The study uses a randomized controlled design (with independent treatment arm allocation), intention-to-treat primary outcome analysis, biological markers for the primary outcome of abstinence, long-term follow-up assessments, precise measurement of intervention dose, and a cost-effectiveness analysis. Input from community providers during protocol development highlighted potential concerns and helped to address issues of practicality and feasibility. Collaboration between providers and investigators supports the utility of infrastructures that enhance research partnerships to facilitate effectiveness trials and dissemination of promising, technologically innovative treatments. Outcomes from this study will further the empirical knowledge base on the effectiveness and cost-effectiveness of computer-assisted treatment in clinical treatment settings. Copyright © 2011 Elsevier Inc. All rights reserved.

[Systemic validation of clinical practice guidelines: the AGREE network].

PubMed

Hannes, K; Van Royen, P; Aertgeerts, B; Buntinx, F; Ramaekers, D; Chevalier, P

2005-12-01

Over recent decades, the number of available clinical practice guidelines has enormously grown. Guidelines should meet specific quality criteria to ensure good quality. There is a growing need for the developement of a set of criteria to ensure that potential biases inherent in guideline development have been properly addressed and that the recommendations for practice are valid and reliable. The AGREE-collaboration is an international network that developed an instrument to critically appraise the methodological quality of guidelines. AGREE promotes a clear strategy to produce, disseminate and evaluate guidelines of high quality. In the first phase of the international project the AGREE-instrument was tested in 11 different countries. Based on this experience the instrument was refined and optimised. In the second phase it was disseminated, promoted and evaluated in 18 participating countries. Belgium was one of them. The Belgian partner in the AGREE-project developed 3 workshops and established 13 validation committees to validate guidelines from Belgian developer groups. We collected 33 questionnaires from participants of the workshops and the validation committees, in which we asked for primary experiences and information on the usefulness and applicability of the instrument. We were also interested in the shortcomings of the instrument and potential strategies to bridge them. More efforts should be made to train methodological experts to gain certain skills for a critical appraisal of clinical practice guidelines. Promoting the AGREE-instrument will lead to a broader knowledge and use of quality criteria in guideline development and appraisal. The development and dissemination of an international list of criteria to appraise the quality of guidelines will stimulate the development of methodologically sound guidelines. International comparisons between existing guidelines will lead to a better collaboration between guideline developers throughout the world.

Design and Methodological Considerations of an Effectiveness Trial of a Computer-assisted Intervention: An Example from the NIDA Clinical Trials Network

PubMed Central

Campbell, Aimee N. C.; Nunes, Edward V.; Miele, Gloria M.; Matthews, Abigail; Polsky, Daniel; Ghitza, Udi E.; Turrigiano, Eva; Bailey, Genie L.; VanVeldhuisen, Paul; Chapdelaine, Rita; Froias, Autumn; Stitzer, Maxine L.; Carroll, Kathleen M.; Winhusen, Theresa; Clingerman, Sara; Perez, Livangelie; McClure, Erin; Goldman, Bruce; Crowell, A. Rebecca

2011-01-01

Computer-assisted interventions hold the promise of minimizing two problems that are ubiquitous in substance abuse treatment: the lack of ready access to treatment and the challenges to providing empirically-supported treatments. Reviews of research on computer-assisted treatments for mental health and substance abuse report promising findings, but study quality and methodological limitations remain an issue. In addition, relatively few computer-assisted treatments have been tested among illicit substance users. This manuscript describes the methodological considerations of a multi-site effectiveness trial conducted within the National Institute on Drug Abuse's (NIDA's) National Drug Abuse Treatment Clinical Trials Network (CTN). The study is evaluating a web-based version of the Community Reinforcement Approach, in addition to prize-based contingency management, among 500 participants enrolled in 10 outpatient substance abuse treatment programs. Several potential effectiveness trial designs were considered and the rationale for the choice of design in this study is described. The study uses a randomized controlled design (with independent treatment arm allocation), intention-to-treat primary outcome analysis, biological markers for the primary outcome of abstinence, long-term follow-up assessments, precise measurement of intervention dose, and a cost-effectiveness analysis. Input from community providers during protocol development highlighted potential concerns and helped to address issues of practicality and feasibility. Collaboration between providers and investigators supports the utility of infrastructures that enhance research partnerships to facilitate effectiveness trials and dissemination of promising, technologically innovative treatments. Outcomes from this study will further the empirical knowledge base on the effectiveness and cost-effectiveness of computer-assisted treatment in clinical treatment settings. PMID:22085803

Interoperability of clinical decision-support systems and electronic health records using archetypes: a case study in clinical trial eligibility.

PubMed

Marcos, Mar; Maldonado, Jose A; Martínez-Salvador, Begoña; Boscá, Diego; Robles, Montserrat

2013-08-01

Clinical decision-support systems (CDSSs) comprise systems as diverse as sophisticated platforms to store and manage clinical data, tools to alert clinicians of problematic situations, or decision-making tools to assist clinicians. Irrespective of the kind of decision-support task CDSSs should be smoothly integrated within the clinical information system, interacting with other components, in particular with the electronic health record (EHR). However, despite decades of developments, most CDSSs lack interoperability features. We deal with the interoperability problem of CDSSs and EHRs by exploiting the dual-model methodology. This methodology distinguishes a reference model and archetypes. A reference model is represented by a stable and small object-oriented model that describes the generic properties of health record information. For their part, archetypes are reusable and domain-specific definitions of clinical concepts in the form of structured and constrained combinations of the entities of the reference model. We rely on archetypes to make the CDSS compatible with EHRs from different institutions. Concretely, we use archetypes for modelling the clinical concepts that the CDSS requires, in conjunction with a series of knowledge-intensive mappings relating the archetypes to the data sources (EHR and/or other archetypes) they depend on. We introduce a comprehensive approach, including a set of tools as well as methodological guidelines, to deal with the interoperability of CDSSs and EHRs based on archetypes. Archetypes are used to build a conceptual layer of the kind of a virtual health record (VHR) over the EHR whose contents need to be integrated and used in the CDSS, associating them with structural and terminology-based semantics. Subsequently, the archetypes are mapped to the EHR by means of an expressive mapping language and specific-purpose tools. We also describe a case study where the tools and methodology have been employed in a CDSS to support patient recruitment in the framework of a clinical trial for colorectal cancer screening. The utilisation of archetypes not only has proved satisfactory to achieve interoperability between CDSSs and EHRs but also offers various advantages, in particular from a data model perspective. First, the VHR/data models we work with are of a high level of abstraction and can incorporate semantic descriptions. Second, archetypes can potentially deal with different EHR architectures, due to their deliberate independence of the reference model. Third, the archetype instances we obtain are valid instances of the underlying reference model, which would enable e.g. feeding back the EHR with data derived by abstraction mechanisms. Lastly, the medical and technical validity of archetype models would be assured, since in principle clinicians should be the main actors in their development. Copyright © 2013 Elsevier Inc. All rights reserved.

Medicine, methodology, and values: trade-offs in clinical science and practice.

PubMed

Ho, Vincent K Y

2011-01-01

The current guidelines of evidence-based medicine (EBM) presuppose that clinical research and clinical practice should advance from rigorous scientific tests as they generate reliable, value-free knowledge. Under this presupposition, hypotheses postulated by doctors and patients in the process of their decision making are preferably tested in randomized clinical trials (RCTs), and in systematic reviews and meta-analyses summarizing outcomes from multiple RCTs. Since testing under this scheme is predominantly focused on the criteria of generality and precision achieved through methodological rigor, at the cost of the criterion of realism, translating test results to clinical practice is often problematic. Choices concerning which methodological criteria should have priority are inevitable, however, as clinical trials, and scientific research in general, cannot meet all relevant criteria at the same time. Since these choices may be informed by considerations external to science, we must acknowledge that science cannot be value-free in a strict sense, and this invites a more prominent role for value-laden considerations in evaluating clinical research. The urgency for this becomes even more apparent when we consider the important yet implicit role of scientific theories in EBM, which may also be subjected to methodological evaluation and for which selectiveness in methodological focus is likewise inevitable.

A systematic review investigating the relationship between efficacy and stimulation parameters when using transcutaneous electrical nerve stimulation after knee arthroplasty

PubMed Central

Beckwée, David; Bautmans, Ivan; Swinnen, Eva; Vermet, Yorick; Lefeber, Nina; Lievens, Pierre

2014-01-01

Objective: To evaluate the clinical efficacy of transcutaneous electric nerve stimulation in the treatment of postoperative knee arthroplasty pain and to relate these results to the stimulation parameters used. Data Sources: PubMed, Pedro and Web of Knowledge were systematically screened for studies investigating effects of transcutaneous electric nerve stimulation on postoperative knee arthroplasty pain. Review Methods: Studies were screened for their methodological and therapeutical quality. We appraised the influence of the stimulation settings used and indicated whether or not a neurophysiological and/or mechanistic rationale was given for these stimulation settings. Results: A total of 5 articles met the inclusion criteria. In total, 347 patients were investigated. The number of patients who received some form of transcutaneous electric nerve stimulation was 117, and 54 patients received sham transcutaneous electric nerve stimulation. Pain was the primary outcome in all studies. The stimulation settings used in the studies (n = 2) that reported significant effects differed from the others as they implemented a submaximal stimulation intensity. Stimulation parameters were heterogeneous, and only one study provided a rationale for them. Conclusion: This review reveals that an effect of transcutaneous electric nerve stimulation might have been missed due to low methodological and therapeutical quality. Justifying the choice of transcutaneous electric nerve stimulation parameters may improve therapeutical quality. PMID:26770730

Translational models of infection prevention and control: lessons from studying high risk aging populations.

PubMed

Mody, Lona

2018-06-13

The present review describes our research experiences and efforts in advancing the field of infection prevention and control in nursing facilities including postacute and long-term care settings. There are over two million infections in postacute and long-term care settings each year in the United States and $4 billion in associated costs. To define a target group most amenable to infection prevention and control interventions, we sought to quantify the relation between indwelling device use and microbial colonization in nursing facility patients. Using various methodologies including survey methods, observational epidemiology, randomized controlled studies, and collaboratives, we showed that indwelling device type is related to the site of multidrug-resistant organism (MDRO) colonization; multianatomic site colonization with MDROs is common; community-associated methicillin-resistant Staphylococcus aureus (MRSA) appeared in the nursing facility setting almost immediately following its emergence in acute care; (4) MDRO prevalence and catheter-associated infection rates can be reduced through a multimodal targeted infection prevention intervention; and (5) using a collaborative approach, such an intervention can be successfully scaled up. Our work advances the infection prevention field through translational research utilizing various methodologies, including quantitative and qualitative surveys, patient-oriented randomized controlled trials, and clinical microbiologic and molecular methods. The resulting interventions employ patient-oriented methods to reduce infections and antimicrobial resistance, and with partnerships from major national entities, can be implemented nationally.

The role of technical advances in the adoption and integration of patient-reported outcomes in clinical care.

PubMed

Jensen, Roxanne E; Rothrock, Nan E; DeWitt, Esi M; Spiegel, Brennan; Tucker, Carole A; Crane, Heidi M; Forrest, Christopher B; Patrick, Donald L; Fredericksen, Rob; Shulman, Lisa M; Cella, David; Crane, Paul K

2015-02-01

Patient-reported outcomes (PROs) are gaining recognition as key measures for improving the quality of patient care in clinical care settings. Three factors have made the implementation of PROs in clinical care more feasible: increased use of modern measurement methods in PRO design and validation, rapid progression of technology (eg, touchscreen tablets, Internet accessibility, and electronic health records), and greater demand for measurement and monitoring of PROs by regulators, payers, accreditors, and professional organizations. As electronic PRO collection and reporting capabilities have improved, the challenges of collecting PRO data have changed. To update information on PRO adoption considerations in clinical care, highlighting electronic and technical advances with respect to measure selection, clinical workflow, data infrastructure, and outcomes reporting. Five practical case studies across diverse health care settings and patient populations are used to explore how implementation barriers were addressed to promote the successful integration of PRO collection into the clinical workflow. The case studies address selecting and reporting of relevant content, workflow integration, previsit screening, effective evaluation, and electronic health record integration. These case studies exemplify elements of well-designed electronic systems, including response automation, tailoring of item selection and reporting algorithms, flexibility of collection location, and integration with patient health care data elements. They also highlight emerging logistical barriers in this area, such as the need for specialized technological and methodological expertise, and design limitations of current electronic data capture systems.

The Role of Technical Advances in the Adoption and Integration of Patient-Reported Outcomes in Clinical Care

PubMed Central

Jensen, Roxanne E.; Rothrock, Nan E.; DeWitt, Esi Morgan; Spiegel, Brennan; Tucker, Carole A.; Crane, Heidi M.; Forrest, Christopher B.; Patrick, Donald L.; Fredericksen, Rob; Shulman, Lisa M.; Cella, David; Crane, Paul K.

2016-01-01

Background Patient-reported outcomes (PROs) are gaining recognition as key measures for improving the quality of patient care in clinical care settings. Three factors have made the implementation of PROs in clinical care more feasible: increased use of modern measurement methods in PRO design and validation, rapid progression of technology (e.g., touch screen tablets, Internet accessibility, and electronic health records (EHRs)), and greater demand for measurement and monitoring of PROs by regulators, payers, accreditors, and professional organizations. As electronic PRO collection and reporting capabilities have improved, the challenges of collecting PRO data have changed. Objectives To update information on PRO adoption considerations in clinical care, highlighting electronic and technical advances with respect to measure selection, clinical workflow, data infrastructure, and outcomes reporting. Methods Five practical case studies across diverse healthcare settings and patient populations are used to explore how implementation barriers were addressed to promote the successful integration of PRO collection into the clinical workflow. The case studies address selecting and reporting of relevant content, workflow integration, pre-visit screening, effective evaluation, and EHR integration. Conclusions These case studies exemplify elements of well-designed electronic systems, including response automation, tailoring of item selection and reporting algorithms, flexibility of collection location, and integration with patient health care data elements. They also highlight emerging logistical barriers in this area, such as the need for specialized technological and methodological expertise, and design limitations of current electronic data capture systems. PMID:25588135

A Novel Consensus-Based Particle Swarm Optimization-Assisted Trust-Tech Methodology for Large-Scale Global Optimization.

PubMed

Zhang, Yong-Feng; Chiang, Hsiao-Dong

2017-09-01

A novel three-stage methodology, termed the "consensus-based particle swarm optimization (PSO)-assisted Trust-Tech methodology," to find global optimal solutions for nonlinear optimization problems is presented. It is composed of Trust-Tech methods, consensus-based PSO, and local optimization methods that are integrated to compute a set of high-quality local optimal solutions that can contain the global optimal solution. The proposed methodology compares very favorably with several recently developed PSO algorithms based on a set of small-dimension benchmark optimization problems and 20 large-dimension test functions from the CEC 2010 competition. The analytical basis for the proposed methodology is also provided. Experimental results demonstrate that the proposed methodology can rapidly obtain high-quality optimal solutions that can contain the global optimal solution. The scalability of the proposed methodology is promising.

Towards the unification of inference structures in medical diagnostic tasks.

PubMed

Mira, J; Rives, J; Delgado, A E; Martínez, R

1998-01-01

The central purpose of artificial intelligence applied to medicine is to develop models for diagnosis and therapy planning at the knowledge level, in the Newell sense, and software environments to facilitate the reduction of these models to the symbol level. The usual methodology (KADS, Common-KADS, GAMES, HELIOS, Protégé, etc) has been to develop libraries of generic tasks and reusable problem-solving methods with explicit ontologies. The principal problem which clinicians have with these methodological developments concerns the diversity and complexity of new terms whose meaning is not sufficiently clear, precise, unambiguous and consensual for them to be accessible in the daily clinical environment. As a contribution to the solution of this problem, we develop in this article the conjecture that one inference structure is enough to describe the set of analysis tasks associated with medical diagnoses. To this end, we first propose a modification of the systematic diagnostic inference scheme to obtain an analysis generic task and then compare it with the monitoring and the heuristic classification task inference schemes using as comparison criteria the compatibility of domain roles (data structures), the similarity in the inferences, and the commonality in the set of assumptions which underlie the functionally equivalent models. The equivalences proposed are illustrated with several examples. Note that though our ongoing work aims to simplify the methodology and to increase the precision of the terms used, the proposal presented here should be viewed more in the nature of a conjecture.

Validating the use of Hospital Episode Statistics data and comparison of costing methodologies for economic evaluation: an end-of-life case study from the Cluster randomised triAl of PSA testing for Prostate cancer (CAP)

PubMed Central

Thorn, Joanna C; Turner, Emma L; Hounsome, Luke; Walsh, Eleanor; Down, Liz; Verne, Julia; Donovan, Jenny L; Neal, David E; Hamdy, Freddie C; Martin, Richard M; Noble, Sian M

2016-01-01

Objectives To evaluate the accuracy of routine data for costing inpatient resource use in a large clinical trial and to investigate costing methodologies. Design Final-year inpatient cost profiles were derived using (1) data extracted from medical records mapped to the National Health Service (NHS) reference costs via service codes and (2) Hospital Episode Statistics (HES) data using NHS reference costs. Trust finance departments were consulted to obtain costs for comparison purposes. Setting 7 UK secondary care centres. Population A subsample of 292 men identified as having died at least a year after being diagnosed with prostate cancer in Cluster randomised triAl of PSA testing for Prostate cancer (CAP), a long-running trial to evaluate the effectiveness and cost-effectiveness of prostate-specific antigen (PSA) testing. Results Both inpatient cost profiles showed a rise in costs in the months leading up to death, and were broadly similar. The difference in mean inpatient costs was £899, with HES data yielding ∼8% lower costs than medical record data (differences compatible with chance, p=0.3). Events were missing from both data sets. 11 men (3.8%) had events identified in HES that were all missing from medical record review, while 7 men (2.4%) had events identified in medical record review that were all missing from HES. The response from finance departments to requests for cost data was poor: only 3 of 7 departments returned adequate data sets within 6 months. Conclusions Using HES routine data coupled with NHS reference costs resulted in mean annual inpatient costs that were very similar to those derived via medical record review; therefore, routinely available data can be used as the primary method of costing resource use in large clinical trials. Neither HES nor medical record review represent gold standards of data collection. Requesting cost data from finance departments is impractical for large clinical trials. Trial registration number ISRCTN92187251; Pre-results. PMID:27130167

Applying health information technology and team-based care to residency education.

PubMed

Brown, Kristy K; Master-Hunter, Tara A; Cooke, James M; Wimsatt, Leslie A; Green, Lee A

2011-01-01

Training physicians capable of practicing within the Patient-centered Medical Home (PCMH) is an emerging area of scholarly inquiry within residency education. This study describes an effort to integrate PCMH principles into teaching practices within a university-based residency setting and evaluates the effect on clinical performance. Using participant feedback and clinical data extracted from an electronic clinical quality management system, we retrospectively examined performance outcomes at two family medicine residency clinics over a 7-year period. Instructional approaches were identified and clinical performance patterns analyzed. Alumni ratings of the practice-based curriculum increased following institution of the PCMH model. Clinical performance outcomes indicated improvements in the delivery of clinical care to patients. Implementation of instructional methodologies posed some challenges to residency faculty, particularly in development of consistent scheduling of individualized feedback sessions. Residents required the greatest support and guidance in managing point-of-care clinical reminders during patient encounters. Teaching practices that take into consideration the integration of team-based care and use of electronic health technologies can successfully be used to deliver residency education in the context of the PCMH model. Ongoing assessment provides important information to residency directors and faculty in support of improving the quality of clinical instruction.

Wild-type MIC distribution and epidemiological cut-off values in clinical Legionella pneumophila serogroup 1 isolates.

PubMed

Bruin, Jacob P; Ijzerman, Ed P F; den Boer, Jeroen W; Mouton, Johan W; Diederen, Bram M W

2012-01-01

The purpose of this study was to establish wild-type (WT) distributions and determine the epidemiological cut-off values (ECOFF) in clinical L. pneumophila serogroup 1 isolates for 10 antimicrobials commonly used for the treatment of Legionella infections using a method feasible in a routine clinical laboratory. MICs of 183 clinical L. pneumophila serogroup 1 isolates, collected as part of an outbreak detection program, were tested using E-test methodology on buffered charcoal yeast extract agar supplemented with α-ketoglutarate (BCYE-α). The MICs were read after 2 days of incubation at 35 °C with increased humidity and without CO(2). ECOFFs were determined according to EUCAST methodology and expressed as WT ≤ X mg/L. All antimicrobials showed a WT distribution, although the width varied from 2 two-fold dilutions to 8 dilutions, depending on antibiotic class. The ECOFFs determined were 1.0 mg/L for ciprofloxacin, 0.50 mg/L for levofloxacin, 1.0 mg/L for moxifloxacin, 1.0 mg/L for erythromycin, 1.0 mg/L for azithromycin, 0.50 mg/L for clarithromycin, 1.0 mg/L for cefotaxime, 0.032 mg/L for rifampicin, 16 mg/L for tigecycline, and 8 mg/L for doxycycline. All isolates were inhibited by low concentrations of the fluoroquinolones and macrolides tested, with somewhat higher MICs for the fluoroquinolones. Rifampicin was found to be the most active against L. pneumophila isolates in vitro. These data can be used as a reference for the detection of resistance in clinical L. pneumophila isolates and as a setting of clinical breakpoints. Copyright © 2012 Elsevier Inc. All rights reserved.

A Comparison of General Medical and Clinical Ethics Consultations: What Can We Learn From Each Other?

PubMed Central

Geppert, Cynthia M.A.; Shelton, Wayne N.

2012-01-01

Despite the emergence of clinical ethics consultation as a clinical service in recent years, little is known about how clinical ethics consultation differs from, or is the same as, other medical consultations. A critical assessment of the similarities and differences between these 2 types of consultations is important to help the medical community appreciate ethics consultation as a vital service in today's health care setting. Therefore, this Special Article presents a comparison of medical and clinical ethics consultations in terms of fundamental goals of consultation, roles of consultants, and methodologic approaches to consultation, concluding with reflections on important lessons about the physician-patient relationship and medical education that may benefit practicing internists. Our aim is to examine ethics consultation as a clinical service integral to the medical care of patients. Studies for this analysis were obtained through the PubMed database using the keywords ethics consultation, medical consultation, ethics consults, medical consults, ethics consultants, and medical consultants. All English-language articles published from 1970 through August 2011 that pertained to the structure and process of medical and ethics consultation were reviewed. PMID:22469350

Model for investigating the benefits of clinical supervision in psychiatric nursing: a survey study.

PubMed

Gonge, Henrik; Buus, Niels

2011-04-01

The objective of this study was to test a model for analysing the possible benefits of clinical supervision. The model suggested a pathway from participation to effectiveness to benefits of clinical supervision, and included possible influences of individual and workplace factors. The study sample was 136 nursing staff members in permanent employment on nine general psychiatric wards and at four community mental health centres at a Danish psychiatric university hospital. Data were collected by means of a set of questionnaires. Participation in clinical supervision was associated with the effectiveness of clinical supervision, as measured by the Manchester Clinical Supervision Scale (MCSS). Furthermore, MCSS scores were associated with benefits, such as increased job satisfaction, vitality, rational coping and less stress, emotional exhaustion, and depersonalization. Multivariate analyses indicated that certain individual and workplace factors were related to subscales of the MCSS, as well as some of the benefits. The study supported the suggested model, but methodological limitations apply. © 2011 The Authors. International Journal of Mental Health Nursing © 2011 Australian College of Mental Health Nurses Inc.

Case formulation and management using pattern-based formulation (PBF) methodology: clinical case 1.

PubMed

Fernando, Irosh; Cohen, Martin

2014-02-01

A tool for psychiatric case formulation known as pattern-based formulation (PBF) has been recently introduced. This paper presents an application of this methodology in formulating and managing complex clinical cases. The symptomatology of the clinical presentation has been parsed into individual clinical phenomena and interpreted by selecting explanatory models. The clinical presentation demonstrates how PBF has been used as a clinical tool to guide clinicians' thinking, that takes a structured approach to manage multiple issues using a broad range of management strategies. In doing so, the paper also introduces a number of patterns related to the observed clinical phenomena that can be re-used as explanatory models when formulating other clinical cases. It is expected that this paper will assist clinicians, and particularly trainees, to better understand PBF methodology and apply it to improve their formulation skills.

Systematic Review of the Application of Lean and Six Sigma Quality Improvement Methodologies in Radiology.

PubMed

Amaratunga, Thelina; Dobranowski, Julian

2016-09-01

Preventable yet clinically significant rates of medical error remain systemic, while health care spending is at a historic high. Industry-based quality improvement (QI) methodologies show potential for utility in health care and radiology because they use an empirical approach to reduce variability and improve workflow. The aim of this review was to systematically assess the literature with regard to the use and efficacy of Lean and Six Sigma (the most popular of the industrial QI methodologies) within radiology. MEDLINE, the Allied & Complementary Medicine Database, Embase Classic + Embase, Health and Psychosocial Instruments, and the Ovid HealthStar database, alongside the Cochrane Library databases, were searched on June 2015. Empirical studies in peer-reviewed journals were included if they assessed the use of Lean, Six Sigma, or Lean Six Sigma with regard to their ability to improve a variety of quality metrics in a radiology-centered clinical setting. Of the 278 articles returned, 23 studies were suitable for inclusion. Of these, 10 assessed Six Sigma, 7 assessed Lean, and 6 assessed Lean Six Sigma. The diverse range of measured outcomes can be organized into 7 common aims: cost savings, reducing appointment wait time, reducing in-department wait time, increasing patient volume, reducing cycle time, reducing defects, and increasing staff and patient safety and satisfaction. All of the included studies demonstrated improvements across a variety of outcomes. However, there were high rates of systematic bias and imprecision as per the Grading of Recommendations Assessment, Development and Evaluation guidelines. Lean and Six Sigma QI methodologies have the potential to reduce error and costs and improve quality within radiology. However, there is a pressing need to conduct high-quality studies in order to realize the true potential of these QI methodologies in health care and radiology. Recommendations on how to improve the quality of the literature are proposed. Copyright © 2016 American College of Radiology. Published by Elsevier Inc. All rights reserved.

[Strengthening innovation in clinical research methodology of acupuncture and moxibustion to promote internationalization process of acupuncture-moxibustion].

PubMed

Wang, Long; Zou, Wei; Chi, Qing-bin

2009-06-01

In order to explore the problems and countermeasure in the methodology of acupuncture and moxibustion clinical researches at present, clinical research literatures about acupuncture and moxibustion (Acup-Mox) published in recent years in our country were reviewed. For the urgent need of the current internationalization of Acup-Mox, the authors proposed the model of clinical research on Acup-Mox, which should strictly stick to the international standard and fully embody traditional Chinese medicine characteristics in the intervention measures of acupuncture. It is indicated that innovation of the methodology about clinical researches of Acup-Mox has great significance in improving the quality of clinical research on Acup-Mox in our country and promoting internationalization of Acup-Mox.

Strategies for conducting adolescent health research in the clinical setting: the Mount Sinai Adolescent Health Center HPV experience.

PubMed

Braun-Courville, Debra K; Schlecht, Nicolas F; Burk, Robert D; Strickler, Howard D; Rojas, Mary; Lorde-Rollins, Elizabeth; Nucci-Sack, Anne; Hollman, Dominic; Linares, L Oriana; Diaz, Angela

2014-10-01

Clinical research with adolescents can be challenging due to issues of informed consent, parental involvement, institutional review board requirements, and adolescent psychosocial development. These requirements present a dilemma, particularly in the area of sexual health research, as adolescents are disproportionately affected by sexually transmitted infections such as human papillomavirus (HPV). To successfully conduct adolescent research in the clinical setting, one requires an awareness of state statutes regarding adolescent confidentiality and consent for medical care, and a close partnership with the IRB. In 2007, the Mount Sinai Adolescent Health Center in collaboration with the Albert Einstein College of Medicine developed a longitudinal research study to examine the natural history of oral, cervical, and anal HPV in an adolescent female population engaged in high-risk sexual behaviors. We use this research project as a case study to explore the ethical, methodological, and clinical issues related to conducting adolescent health research. Several strategies were identified to promote adolescent study participation, including: (1) building a research team that is motivated to work with adolescents; (2) combining research and patient care visits to avoid duplication of services; and (3) establishing a personalized communication network with participants. Using these methods, adolescent sexual health research can successfully be integrated into the clinical setting. While retaining a prospective cohort of adolescents has its challenges, a persistent and multi-disciplinary approach can help improve recruitment, sustain participation, and acquire critical data that will lead to improved healthcare knowledge applicable to understudied populations of adolescents. Copyright © 2014 North American Society for Pediatric and Adolescent Gynecology. Published by Elsevier Inc. All rights reserved.

Measuring molecular biomarkers in epidemiologic studies: laboratory techniques and biospecimen considerations.

PubMed

Erickson, Heidi S

2012-09-28

The future of personalized medicine depends on the ability to efficiently and rapidly elucidate a reliable set of disease-specific molecular biomarkers. High-throughput molecular biomarker analysis methods have been developed to identify disease risk, diagnostic, prognostic, and therapeutic targets in human clinical samples. Currently, high throughput screening allows us to analyze thousands of markers from one sample or one marker from thousands of samples and will eventually allow us to analyze thousands of markers from thousands of samples. Unfortunately, the inherent nature of current high throughput methodologies, clinical specimens, and cost of analysis is often prohibitive for extensive high throughput biomarker analysis. This review summarizes the current state of high throughput biomarker screening of clinical specimens applicable to genetic epidemiology and longitudinal population-based studies with a focus on considerations related to biospecimens, laboratory techniques, and sample pooling. Copyright © 2012 John Wiley & Sons, Ltd.

The Clinical Delivery of Pharmacogenetic Testing Services: A Proposed Partnership between Genetic Counselors and Pharmacists

PubMed Central

Mills, Rachel; Haga, Susanne B.

2013-01-01

One of the basic questions in the early uses of pharmacogenetic (PGx) testing revolves around the clinical delivery of testing. Because multiple health professionals may play a role in the delivery of PGx testing, various clinical delivery models have begun to be studied. We propose that a partnership between genetic counselors and pharmacists can assist clinicians in the delivery of comprehensive PGx services. Based on their expert knowledge of pharmacokinetics and pharmacodynamics, pharmacists can facilitate the appropriate application of PGx test results to adjust medication use as warranted and act as a liaison to the healthcare team recommending changes in medication based on test results and patient input. Genetic counselors are well-trained in genetics as well as risk communication and counseling methodology, but have limited knowledge of pharmaceuticals. The complementary knowledge and skill set supports the partnership between genetic counselors and pharmacists to provide effective PGx testing services. PMID:23746189

Understanding the role of physician attire on patient perceptions: a systematic review of the literature— targeting attire to improve likelihood of rapport (TAILOR) investigators

PubMed Central

Petrilli, Christopher Michael; Mack, Megan; Petrilli, Jennifer Janowitz; Hickner, Andy; Saint, Sanjay; Chopra, Vineet

2015-01-01

Objectives Despite a growing body of literature, uncertainty regarding the influence of physician dress on patients’ perceptions exists. Therefore, we performed a systematic review to examine the influence of physician attire on patient perceptions including trust, satisfaction and confidence. Setting, participants, interventions and outcomes We searched MEDLINE, Embase, Biosis Previews and Conference Papers Index. Studies that: (1) involved participants ≥18 years of age; (2) evaluated physician attire; and (3) reported patient perceptions related to attire were included. Two authors determined study eligibility. Studies were categorised by country of origin, clinical discipline (eg, internal medicine, surgery), context (inpatient vs outpatient) and occurrence of a clinical encounter when soliciting opinions regarding attire. Studies were assessed using the Downs and Black Scale risk of bias scale. Owing to clinical and methodological heterogeneity, meta-analyses were not attempted. Results Of 1040 citations, 30 studies involving 11 533 patients met eligibility criteria. Included studies featured patients from 14 countries. General medicine, procedural (eg, general surgery and obstetrics), clinic, emergency departments and hospital settings were represented. Preferences or positive influence of physician attire on patient perceptions were reported in 21 of the 30 studies (70%). Formal attire and white coats with other attire not specified was preferred in 18 of 30 studies (60%). Preference for formal attire and white coats was more prevalent among older patients and studies conducted in Europe and Asia. Four of seven studies involving procedural specialties reported either no preference for attire or a preference for scrubs; four of five studies in intensive care and emergency settings also found no attire preference. Only 3 of 12 studies that surveyed patients after a clinical encounter concluded that attire influenced patient perceptions. Conclusions Although patients often prefer formal physician attire, perceptions of attire are influenced by age, locale, setting and context of care. Policy-based interventions that target such factors appear necessary. PMID:25600254

Molecular subtyping of diffuse large B-cell lymphoma: update on biology, diagnosis and emerging platforms for practising pathologists.

PubMed

Gifford, Grace K; Gill, Anthony J; Stevenson, William S

2016-01-01

Molecular classification of diffuse large B-cell lymphoma (DLBCL) is critical. Numerous methodologies have demonstrated that DLBCL is biologically heterogeneous despite morphological similarities. This underlies the disparate outcomes of treatment response or failure in this common non-Hodgkin lymphoma. This review will summarise historical approaches to lymphoma classifications, current diagnosis of DLBCL, molecular techniques that have primarily been used in the research setting to distinguish and subclassify DLBCL, evaluate contemporary diagnostic methodologies that seek to translate lymphoma biology into clinical practice, and introduce novel diagnostic platforms that may overcome current issues. The review concludes with an overview of key molecular lesions currently identified in DLBCL, all of which are potential targets for drug treatments that may improve survival and cure. Copyright © 2015 The Royal College of Pathologists of Australasia. Published by Elsevier B.V. All rights reserved.

Making big data useful for health care: a summary of the inaugural mit critical data conference.

PubMed

Badawi, Omar; Brennan, Thomas; Celi, Leo Anthony; Feng, Mengling; Ghassemi, Marzyeh; Ippolito, Andrea; Johnson, Alistair; Mark, Roger G; Mayaud, Louis; Moody, George; Moses, Christopher; Naumann, Tristan; Pimentel, Marco; Pollard, Tom J; Santos, Mauro; Stone, David J; Zimolzak, Andrew

2014-08-22

With growing concerns that big data will only augment the problem of unreliable research, the Laboratory of Computational Physiology at the Massachusetts Institute of Technology organized the Critical Data Conference in January 2014. Thought leaders from academia, government, and industry across disciplines-including clinical medicine, computer science, public health, informatics, biomedical research, health technology, statistics, and epidemiology-gathered and discussed the pitfalls and challenges of big data in health care. The key message from the conference is that the value of large amounts of data hinges on the ability of researchers to share data, methodologies, and findings in an open setting. If empirical value is to be from the analysis of retrospective data, groups must continuously work together on similar problems to create more effective peer review. This will lead to improvement in methodology and quality, with each iteration of analysis resulting in more reliability.

Making Big Data Useful for Health Care: A Summary of the Inaugural MIT Critical Data Conference

PubMed Central

2014-01-01

With growing concerns that big data will only augment the problem of unreliable research, the Laboratory of Computational Physiology at the Massachusetts Institute of Technology organized the Critical Data Conference in January 2014. Thought leaders from academia, government, and industry across disciplines—including clinical medicine, computer science, public health, informatics, biomedical research, health technology, statistics, and epidemiology—gathered and discussed the pitfalls and challenges of big data in health care. The key message from the conference is that the value of large amounts of data hinges on the ability of researchers to share data, methodologies, and findings in an open setting. If empirical value is to be from the analysis of retrospective data, groups must continuously work together on similar problems to create more effective peer review. This will lead to improvement in methodology and quality, with each iteration of analysis resulting in more reliability. PMID:25600172

A methodology for automatic intensity-modulated radiation treatment planning for lung cancer

NASA Astrophysics Data System (ADS)

Zhang, Xiaodong; Li, Xiaoqiang; Quan, Enzhuo M.; Pan, Xiaoning; Li, Yupeng

2011-07-01

In intensity-modulated radiotherapy (IMRT), the quality of the treatment plan, which is highly dependent upon the treatment planner's level of experience, greatly affects the potential benefits of the radiotherapy (RT). Furthermore, the planning process is complicated and requires a great deal of iteration, and is often the most time-consuming aspect of the RT process. In this paper, we describe a methodology to automate the IMRT planning process in lung cancer cases, the goal being to improve the quality and consistency of treatment planning. This methodology (1) automatically sets beam angles based on a beam angle automation algorithm, (2) judiciously designs the planning structures, which were shown to be effective for all the lung cancer cases we studied, and (3) automatically adjusts the objectives of the objective function based on a parameter automation algorithm. We compared treatment plans created in this system (mdaccAutoPlan) based on the overall methodology with plans from a clinical trial of IMRT for lung cancer run at our institution. The 'autoplans' were consistently better, or no worse, than the plans produced by experienced medical dosimetrists in terms of tumor coverage and normal tissue sparing. We conclude that the mdaccAutoPlan system can potentially improve the quality and consistency of treatment planning for lung cancer.

An unbiased Hessian representation for Monte Carlo PDFs.

PubMed

Carrazza, Stefano; Forte, Stefano; Kassabov, Zahari; Latorre, José Ignacio; Rojo, Juan

We develop a methodology for the construction of a Hessian representation of Monte Carlo sets of parton distributions, based on the use of a subset of the Monte Carlo PDF replicas as an unbiased linear basis, and of a genetic algorithm for the determination of the optimal basis. We validate the methodology by first showing that it faithfully reproduces a native Monte Carlo PDF set (NNPDF3.0), and then, that if applied to Hessian PDF set (MMHT14) which was transformed into a Monte Carlo set, it gives back the starting PDFs with minimal information loss. We then show that, when applied to a large Monte Carlo PDF set obtained as combination of several underlying sets, the methodology leads to a Hessian representation in terms of a rather smaller set of parameters (MC-H PDFs), thereby providing an alternative implementation of the recently suggested Meta-PDF idea and a Hessian version of the recently suggested PDF compression algorithm (CMC-PDFs). The mc2hessian conversion code is made publicly available together with (through LHAPDF6) a Hessian representations of the NNPDF3.0 set, and the MC-H PDF set.

Using systems thinking to support clinical system transformation.

PubMed

Best, Allan; Berland, Alex; Herbert, Carol; Bitz, Jennifer; van Dijk, Marlies W; Krause, Christina; Cochrane, Douglas; Noel, Kevin; Marsden, Julian; McKeown, Shari; Millar, John

2016-05-16

Purpose - The British Columbia Ministry of Health's Clinical Care Management initiative was used as a case study to better understand large-scale change (LSC) within BC's health system. Using a complex system framework, the purpose of this paper is to examine mechanisms that enable and constrain the implementation of clinical guidelines across various clinical settings. Design/methodology/approach - Researchers applied a general model of complex adaptive systems plus two specific conceptual frameworks (realist evaluation and system dynamics mapping) to define and study enablers and constraints. Focus group sessions and interviews with clinicians, executives, managers and board members were validated through an online survey. Findings - The functional themes for managing large-scale clinical change included: creating a context to prepare clinicians for health system transformation initiatives; promoting shared clinical leadership; strengthening knowledge management, strategic communications and opportunities for networking; and clearing pathways through the complexity of a multilevel, dynamic system. Research limitations/implications - The action research methodology was designed to guide continuing improvement of implementation. A sample of initiatives was selected; it was not intended to compare and contrast facilitators and barriers across all initiatives and regions. Similarly, evaluating the results or process of guideline implementation was outside the scope; the methods were designed to enable conversations at multiple levels - policy, management and practice - about how to improve implementation. The study is best seen as a case study of LSC, offering a possible model for replication by others and a tool to shape further dialogue. Practical implications - Recommended action-oriented strategies included engaging local champions; supporting local adaptation for implementation of clinical guidelines; strengthening local teams to guide implementation; reducing change fatigue; ensuring adequate resources; providing consistent communication especially for front-line care providers; and supporting local teams to demonstrate the clinical value of the guidelines to their colleagues. Originality/value - Bringing a complex systems perspective to clinical guideline implementation resulted in a clear understanding of the challenges involved in LSC.

Can we decide which outcomes should be measured in every clinical trial? A scoping review of the existing conceptual frameworks and processes to develop core outcome sets.

PubMed

Idzerda, Leanne; Rader, Tamara; Tugwell, Peter; Boers, Maarten

2014-05-01

The usefulness of randomized control trials to advance clinical care depends upon the outcomes reported, but disagreement on the choice of outcome measures has resulted in inconsistency and the potential for reporting bias. One solution to this problem is the development of a core outcome set: a minimum set of outcome measures deemed critical for clinical decision making. Within rheumatology the Outcome Measures in Rheumatology (OMERACT) initiative has pioneered the development of core outcome sets since 1992. As the number of diseases addressed by OMERACT has increased and its experience in formulating core sets has grown, clarification and update of the conceptual framework and formulation of a more explicit process of area/domain core set development has become necessary. As part of the update process of the OMERACT Filter criteria to version 2, a literature review was undertaken to compare and contrast the OMERACT conceptual framework with others within and outside rheumatology. A scoping search was undertaken to examine the extent, range, and nature of conceptual frameworks for core set outcome selection in health. We searched the following resources: Cochrane Library Methods Group Register; Medline; Embase; PsycInfo; Environmental Studies and Policy Collection; and ABI/INFORM Global. We also conducted a targeted Google search. Five conceptual frameworks were identified: the WHO tripartite definition of health; the 5 Ds (discomfort, disability, drug toxicity, dollar cost, and death); the International Classification of Functioning (ICF); PROMIS (Patient-Reported Outcomes Measurement System); and the Outcomes Hierarchy. Of these, only the 5 Ds and ICF frameworks have been systematically applied in core set development. Outside the area of rheumatology, several core sets were identified; these had been developed through a limited range of consensus-based methods with varying degrees of methodological rigor. None applied a framework to ensure content validity of the end product. This scoping review reinforced the need for clear methods and standards for core set development. Based on these findings, OMERACT will make its own conceptual framework and working process more explicit. Proposals for how to achieve this were discussed at the OMERACT 11 conference.

Utility-based designs for randomized comparative trials with categorical outcomes

PubMed Central

Murray, Thomas A.; Thall, Peter F.; Yuan, Ying

2016-01-01

A general utility-based testing methodology for design and conduct of randomized comparative clinical trials with categorical outcomes is presented. Numerical utilities of all elementary events are elicited to quantify their desirabilities. These numerical values are used to map the categorical outcome probability vector of each treatment to a mean utility, which is used as a one-dimensional criterion for constructing comparative tests. Bayesian tests are presented, including fixed sample and group sequential procedures, assuming Dirichlet-multinomial models for the priors and likelihoods. Guidelines are provided for establishing priors, eliciting utilities, and specifying hypotheses. Efficient posterior computation is discussed, and algorithms are provided for jointly calibrating test cutoffs and sample size to control overall type I error and achieve specified power. Asymptotic approximations for the power curve are used to initialize the algorithms. The methodology is applied to re-design a completed trial that compared two chemotherapy regimens for chronic lymphocytic leukemia, in which an ordinal efficacy outcome was dichotomized and toxicity was ignored to construct the trial’s design. The Bayesian tests also are illustrated by several types of categorical outcomes arising in common clinical settings. Freely available computer software for implementation is provided. PMID:27189672

Determining the Performance of Fluorescence Molecular Imaging Devices using Traceable Working Standards with SI Units of Radiance

PubMed Central

Zhu, Banghe; Rasmussen, John C.; Litorja, Maritoni

2017-01-01

To date, no emerging preclinical or clinical near-infrared fluorescence (NIRF) imaging devices for non-invasive and/or surgical guidance have their performances validated on working standards with SI units of radiance that enable comparison or quantitative quality assurance. In this work, we developed and deployed a methodology to calibrate a stable, solid phantom for emission radiance with units of mW · sr−1 · cm−2 for use in characterizing the measurement sensitivity of ICCD and IsCMOS detection, signal-to-noise ratio, and contrast. In addition, at calibrated radiances, we assess transverse and lateral resolution of ICCD and IsCMOS camera systems. The methodology allowed determination of superior SNR of the ICCD over the IsCMOS camera system and superior resolution of the IsCMOS over the ICCD camera system. Contrast depended upon the camera settings (binning and integration time) and gain of intensifier. Finally, because of architecture of CMOS and CCD camera systems resulting in vastly different performance, we comment on the utility of these systems for small animal imaging as well as clinical applications for non-invasive and surgical guidance. PMID:26552078

[Is there a German history of evidence-based medicine? Methodic standards of therapeutic research in the early 20th century and Paul Martini's "Methodology of therapeutic investigation" (1932)].

PubMed

Stoll, S; Roelcke, V; Raspe, H

2005-07-29

The article addresses the history of evidence-based medicine in Germany. Its aim was to reconstruct the standard of clinical-therapeutic investigation in Germany at the beginning of the 20 (th) century. By a historical investigation of five important German general medical journals for the time between 1918 and 1932 an overview of the situation of clinical investigation is given. 268 clinical trails are identified, and are analysed in view of their methodological design. Heterogeneous results are found: While few examples of sophisticated methodology exist, the design of the majority of the studies is poor. A response to the situation described can be seen in Paul Martini's book "Methodology of Therapeutic Investigation", first published in 1932. Paul Martini's biography, his criticism of the situation of clinical-therapeutic investigation of his time, the major points of his methodology and the reception of the book in Germany and abroad are described.

The Content Validity of a Chemotherapy-Induced Peripheral Neuropathy Patient-Reported Outcome Measure

PubMed Central

Lavoie Smith, Ellen M.; Haupt, Rylie; Kelly, James P.; Lee, Deborah; Kanzawa-Lee, Grace; Knoerl, Robert; Bridges, Celia; Alberti, Paola; Prasertsri, Nusara; Donohoe, Clare

2018-01-01

Purpose/Objectives To test the content validity of a 16-item version of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire–Chemotherapy-Induced Peripheral Neuropathy (QLQ-CIPN20). Research Approach Cross-sectional, prospective, qualitative design. Setting Six outpatient oncology clinics within the University of Michigan Health System’s comprehensive cancer center in Ann Arbor. Participants 25 adults with multiple myeloma or breast, gynecologic, gastrointestinal, or head and neck malignancies experiencing peripheral neuropathy caused by neurotoxic chemotherapy. Methodologic Approach Cognitive interviewing methodology was used to evaluate the content validity of a 16-item version of the QLQ-CIPN20 instrument. Findings Minor changes were made to three questions to enhance readability. Twelve questions were revised to define unfamiliar terminology, clarify the location of neuropathy, and emphasize important aspects. One question was deleted because of clinical and conceptual redundancy with other items, as well as concerns regarding generalizability and social desirability. Interpretation Cognitive interviewing methodology revealed inconsistencies between patients’ understanding and researchers’ intent, along with points that required clarification to avoid misunderstanding. Implications for Nursing Patients’ interpretations of the instrument’s items were inconsistent with the intended meanings of the questions. One item was dropped and others were revised, resulting in greater consistency in how patients, clinicians, and researchers interpreted the items’ meanings and improving the instrument’s content validity. Following additional revision and psychometric testing, the QLQ-CIPN20 could evolve into a gold-standard CIPN patient-reported outcome measure. PMID:28820525

PET measurements of myocardial blood flow post myocardial infarction: Relationship to invasive and cardiac magnetic resonance studies and potential clinical applications.

PubMed

Gewirtz, Henry

2017-12-01

This review focuses on clinical studies concerning assessment of coronary microvascular and conduit vessel function primarily in the context of acute and sub acute myocardial infarction (MI). The ability of quantitative PET measurements of myocardial blood flow (MBF) to delineate underlying pathophysiology and assist in clinical decision making in this setting is discussed. Likewise, considered are physiological metrics fractional flow reserve, coronary flow reserve, index of microvascular resistance (FFR, CFR, IMR) obtained from invasive studies performed in the cardiac catheterization laboratory, typically at the time of PCI for MI. The role both of invasive studies and cardiac magnetic resonance (CMR) imaging in assessing microvascular function, a key determinant of prognosis, is reviewed. The interface between quantitative PET MBF measurements and underlying pathophysiology, as demonstrated both by invasive and CMR methodology, is discussed in the context of optimal interpretation of the quantitative PET MBF exam and its potential clinical applications.

Comparative Effectiveness and Implementation Research: Directions for Neurology

PubMed Central

Vickrey, Barbara G.; Hirtz, Deborah; Waddy, Salina; Cheng, Eric M.; Johnston, S. Claiborne

2013-01-01

There is an enormous unmet need for knowledge about how new insights from discovery and translational research can yield measurable, population-level improvements in health and reduction in mortality among those having or at risk for neurological disease. Once several, well-conducted randomized controlled trials establish the efficacy of a given therapy, implementation research can generate new knowledge about barriers to uptake of the therapy into widespread clinical care, and what strategies are effective in overcoming those barriers and in addressing health disparities. Comparative effectiveness research aims to elucidate the relative value (including clinical benefit, clinical harms, and/or costs) of alternative efficacious management approaches to a neurological disorder, generally through direct comparisons, and may include comparisons of methodologies for implementation. Congress has recently appropriated resources and established an institute to prioritize funding for such research. Neurologists and neuroscientists should understand the scope and objectives of comparative effectiveness and implementation research, their range of methodological approaches (formal literature syntheses, randomized trials, observational studies, modeling), and existing research resources (centers for literature synthesis, registries, practice networks) relevant to research for neurological conditions, in order to close the well-documented “evidence-to-practice gap.” Future directions include building this research resource capacity, producing scientists trained to conduct rigorous comparative effectiveness and implementation research, and embracing innovative strategies to set research priorities in these areas. PMID:22718542

Why Ineffective Psychotherapies Appear to Work: A Taxonomy of Causes of Spurious Therapeutic Effectiveness.

PubMed

Lilienfeld, Scott O; Ritschel, Lorie A; Lynn, Steven Jay; Cautin, Robin L; Latzman, Robert D

2014-07-01

The past 40 years have generated numerous insights regarding errors in human reasoning. Arguably, clinical practice is the domain of applied psychology in which acknowledging and mitigating these errors is most crucial. We address one such set of errors here, namely, the tendency of some psychologists and other mental health professionals to assume that they can rely on informal clinical observations to infer whether treatments are effective. We delineate four broad, underlying cognitive impediments to accurately evaluating improvement in psychotherapy-naive realism, confirmation bias, illusory causation, and the illusion of control. We then describe 26 causes of spurious therapeutic effectiveness (CSTEs), organized into a taxonomy of three overarching categories: (a) the perception of client change in its actual absence, (b) misinterpretations of actual client change stemming from extratherapeutic factors, and (c) misinterpretations of actual client change stemming from nonspecific treatment factors. These inferential errors can lead clinicians, clients, and researchers to misperceive useless or even harmful psychotherapies as effective. We (a) examine how methodological safeguards help to control for different CSTEs, (b) delineate fruitful directions for research on CSTEs, and (c) consider the implications of CSTEs for everyday clinical practice. An enhanced appreciation of the inferential problems posed by CSTEs may narrow the science-practice gap and foster a heightened appreciation of the need for the methodological safeguards afforded by evidence-based practice. © The Author(s) 2014.

[Formula: see text]Official Position of the American Academy of Clinical Neuropsychology (AACN): Guidelines for Practicum Training in Clinical Neuropsychology.

PubMed

Nelson, Aaron P; Roper, Brad L; Slomine, Beth S; Morrison, Chris; Greher, Michael R; Janusz, Jennifer; Larson, Jennifer C; Meadows, Mary-Ellen; Ready, Rebecca E; Rivera Mindt, Monica; Whiteside, Doug M; Willment, Kim; Wodushek, Thomas R

2015-01-01

Practical experience is central to the education and training of neuropsychologists, beginning in graduate school and extending through postdoctoral fellowship. However, historically, little attention has been given to the structure and requirements of practicum training in clinical neuropsychology. A working group of senior-level neuropsychologists, as well as a current postdoctoral fellow, all from a diverse range of settings (The AACN Practicum Guidelines Workgroup), was formed to propose guidelines for practicum training in clinical neuropsychology. The Workgroup reviewed relevant literature and sought input from professional organizations involved in education and training in neuropsychology. The proposed guidelines provide a definition of practicum training in clinical neuropsychology, detail entry and exit criteria across competencies relevant to practicum training in clinical neuropsychology, and discuss the relationship between doctoral training programs and practicum training sites. The proposed guidelines also provide a methodology for competency-based evaluation of clinical neuropsychology practicum trainees and outline characteristics and features that are integral to an effective training environment. Although the guidelines discussed below may not be implemented in their entirety across all clinical neuropsychology practicum training sites, they are consistent with the latest developments in competency-based education.

Enabling professional development in mental health nursing: the role of clinical leadership.

PubMed

Ennis, G; Happell, B; Reid-Searl, K

2015-10-01

Clinical leadership is acknowledged as important to the nursing profession. While studies continue to identify its significance in contributing to positive outcomes for consumers, the role that clinical leadership has in enabling and supporting professional development in mental health nursing is poorly understood. This study utilized a grounded theory methodology to explore the characteristics clinicians consider important for clinical leadership and its significance for mental health nursing in day-to-day clinical practice. Individual face-to-face, semi-structured interviews were conducted with nurses working in mental health settings. Participants described the important role that clinical leaders play in enabling professional development of others through role modelling and clinical teaching. They describe how nurses, whom they perceive as clinical leaders, use role modelling and clinical teaching to influence the professional development of nursing staff and undergraduate nursing students. Attributes such as professionalism and honesty were seen, by participants, as enablers for clinical leaders in effectively and positively supporting the professional development of junior staff and undergraduate nurses in mental health nursing. This paper examines clinical leadership from the perspective of mental health nurses delivering care, and highlights the important role of clinical leaders in supporting professional development in mental health nursing. © 2015 John Wiley & Sons Ltd.

Modeling Single-Event Transient Propagation in a SiGe BiCMOS Direct-Conversion Receiver

NASA Astrophysics Data System (ADS)

Ildefonso, Adrian; Song, Ickhyun; Tzintzarov, George N.; Fleetwood, Zachary E.; Lourenco, Nelson E.; Wachter, Mason T.; Cressler, John D.

2017-08-01

The propagation of single-event transient (SET) signals in a silicon-germanium direct-conversion receiver carrying modulated data is explored. A theoretical analysis of transient propagation, verified by simulation, is presented. A new methodology to characterize and quantify the impact of SETs in communication systems carrying modulated data is proposed. The proposed methodology uses a pulsed radiation source to induce distortions in the signal constellation. The error vector magnitude due to SETs can then be calculated to quantify errors. Two different modulation schemes were simulated: QPSK and 16-QAM. The distortions in the constellation diagram agree with the presented circuit theory. Furthermore, the proposed methodology was applied to evaluate the improvements in the SET response due to a known radiation-hardening-by-design (RHBD) technique, where the common-base device of the low-noise amplifier was operated in inverse mode. The proposed methodology can be a valid technique to determine the most sensitive parts of a system carrying modulated data.

Examining organizational change in primary care practices: experiences from using ethnographic methods.

PubMed

Russell, Grant; Advocat, Jenny; Geneau, Robert; Farrell, Barbara; Thille, Patricia; Ward, Natalie; Evans, Samantha

2012-08-01

Qualitative methods are an important part of the primary care researcher's toolkit providing a nuanced view of the complexity in primary care reform and delivery. Ethnographic research is a comprehensive approach to qualitative data collection, including observation, in-depth interviews and document analysis. Few studies have been published outlining methodological issues related to ethnography in this setting. This paper examines some of the challenges of conducting an ethnographic study in primary care setting in Canada, where there recently have been major reforms to traditional methods of organizing primary care services. This paper is based on an ethnographic study set in primary care practices in Ontario, Canada, designed to investigate changes to organizational and clinical routines in practices undergoing transition to new, interdisciplinary Family Health Teams (FHTs). The study was set in six new FHTs in Ontario. This paper is a reflexive examination of some of the challenges encountered while conducting an ethnographic study in a primary care setting. Our experiences in this study highlight some potential benefits of and difficulties in conducting an ethnographic study in family practice. Our study design gave us an opportunity to highlight the changes in routines within an organization in transition. A study with a clinical perspective requires training, support, a mixture of backgrounds and perspectives and ongoing communication. Despite some of the difficulties, the richness of this method has allowed the exploration of a number of additional research questions that emerged during data analysis.

A Pilot Examination of the Methods Used to Counteract Insider Threat Security Risks Associated with the Use of Radioactive Materials in the Research and Clinical Setting.

PubMed

Tsenov, B G; Emery, R J; Whitehead, L W; Gonzalez, J Reingle; Gemeinhardt, G L

2018-03-01

While many organizations maintain multiple layers of security control methodologies to prevent outsiders from gaining unauthorized access, persons such as employees or contractors who have been granted legitimate access can represent an "insider threat" risk. Interestingly, some of the most notable radiological events involving the purposeful contamination or exposure of individuals appear to have been perpetrated by insiders. In the academic and medical settings, radiation safety professionals focus their security efforts on (1) ensuring controls are in place to prevent unauthorized access or removal of sources, and (2) increasing security controls for the unescorted accessing of large sources of radioactivity (known as "quantities of concern"). But these controls may not completely address the threat insiders represent when radioactive materials below these quantities are present. The goal of this research project was to characterize the methodologies currently employed to counteract the insider security threat for the misuse or purposeful divergence of radioactive materials used in the academic and medical settings. A web-based survey was used to assess how practicing radiation safety professionals in academic and medical settings anticipate, evaluate, and control insider threat security risks within their institutions. While all respondents indicated that radioactive sources are being used in amounts below quantities of concern, only 6 % consider insider threat security issues as part of the protocol review for the use of general radioactive materials. The results of this survey identify several opportunities for improvement for institutions to address security gaps.

Changes in clinical trials methodology over time: a systematic review of six decades of research in psychopharmacology.

PubMed

Brunoni, André R; Tadini, Laura; Fregni, Felipe

2010-03-03

There have been many changes in clinical trials methodology since the introduction of lithium and the beginning of the modern era of psychopharmacology in 1949. The nature and importance of these changes have not been fully addressed to date. As methodological flaws in trials can lead to false-negative or false-positive results, the objective of our study was to evaluate the impact of methodological changes in psychopharmacology clinical research over the past 60 years. We performed a systematic review from 1949 to 2009 on MEDLINE and Web of Science electronic databases, and a hand search of high impact journals on studies of seven major drugs (chlorpromazine, clozapine, risperidone, lithium, fluoxetine and lamotrigine). All controlled studies published 100 months after the first trial were included. Ninety-one studies met our inclusion criteria. We analyzed the major changes in abstract reporting, study design, participants' assessment and enrollment, methodology and statistical analysis. Our results showed that the methodology of psychiatric clinical trials changed substantially, with quality gains in abstract reporting, results reporting, and statistical methodology. Recent trials use more informed consent, periods of washout, intention-to-treat approach and parametric tests. Placebo use remains high and unchanged over time. Clinical trial quality of psychopharmacological studies has changed significantly in most of the aspects we analyzed. There was significant improvement in quality reporting and internal validity. These changes have increased study efficiency; however, there is room for improvement in some aspects such as rating scales, diagnostic criteria and better trial reporting. Therefore, despite the advancements observed, there are still several areas that can be improved in psychopharmacology clinical trials.

Promoting quality and safety in women's health through the use of transdisciplinary clinical simulation educational modules: methodology and a pilot trial.

PubMed

Montgomery, Kymberlee; Morse, Catherine; Smith-Glasgow, Mary Ellen; Posmontier, Bobbie; Follen, Michele

2012-02-01

This manuscript presents the methodology used to assess the impact of a clinical simulation module used for training providers specializing in women's health. The methodology presented here will be used for a quantitative study in the future. Copyright © 2012 Elsevier HS Journals, Inc. All rights reserved.

Searching for qualitative research for inclusion in systematic reviews: a structured methodological review.

PubMed

Booth, Andrew

2016-05-04

Qualitative systematic reviews or qualitative evidence syntheses (QES) are increasingly recognised as a way to enhance the value of systematic reviews (SRs) of clinical trials. They can explain the mechanisms by which interventions, evaluated within trials, might achieve their effect. They can investigate differences in effects between different population groups. They can identify which outcomes are most important to patients, carers, health professionals and other stakeholders. QES can explore the impact of acceptance, feasibility, meaningfulness and implementation-related factors within a real world setting and thus contribute to the design and further refinement of future interventions. To produce valid, reliable and meaningful QES requires systematic identification of relevant qualitative evidence. Although the methodologies of QES, including methods for information retrieval, are well-documented, little empirical evidence exists to inform their conduct and reporting. This structured methodological overview examines papers on searching for qualitative research identified from the Cochrane Qualitative and Implementation Methods Group Methodology Register and from citation searches of 15 key papers. A single reviewer reviewed 1299 references. Papers reporting methodological guidance, use of innovative methodologies or empirical studies of retrieval methods were categorised under eight topical headings: overviews and methodological guidance, sampling, sources, structured questions, search procedures, search strategies and filters, supplementary strategies and standards. This structured overview presents a contemporaneous view of information retrieval for qualitative research and identifies a future research agenda. This review concludes that poor empirical evidence underpins current information practice in information retrieval of qualitative research. A trend towards improved transparency of search methods and further evaluation of key search procedures offers the prospect of rapid development of search methods.

Methods for the guideline-based development of quality indicators--a systematic review

PubMed Central

2012-01-01

Background Quality indicators (QIs) are used in many healthcare settings to measure, compare, and improve quality of care. For the efficient development of high-quality QIs, rigorous, approved, and evidence-based development methods are needed. Clinical practice guidelines are a suitable source to derive QIs from, but no gold standard for guideline-based QI development exists. This review aims to identify, describe, and compare methodological approaches to guideline-based QI development. Methods We systematically searched medical literature databases (Medline, EMBASE, and CINAHL) and grey literature. Two researchers selected publications reporting methodological approaches to guideline-based QI development. In order to describe and compare methodological approaches used in these publications, we extracted detailed information on common steps of guideline-based QI development (topic selection, guideline selection, extraction of recommendations, QI selection, practice test, and implementation) to predesigned extraction tables. Results From 8,697 hits in the database search and several grey literature documents, we selected 48 relevant references. The studies were of heterogeneous type and quality. We found no randomized controlled trial or other studies comparing the ability of different methodological approaches to guideline-based development to generate high-quality QIs. The relevant publications featured a wide variety of methodological approaches to guideline-based QI development, especially regarding guideline selection and extraction of recommendations. Only a few studies reported patient involvement. Conclusions Further research is needed to determine which elements of the methodological approaches identified, described, and compared in this review are best suited to constitute a gold standard for guideline-based QI development. For this research, we provide a comprehensive groundwork. PMID:22436067

Improving information technology adoption and implementation through the identification of appropriate benefits: creating IMPROVE-IT.

PubMed

Leonard, Kevin J; Sittig, Dean F

2007-05-04

This paper describes the objectives of a collaborative initiative that attempts to provide the evidence that increased information technology (IT) capabilities, availability, and use lead directly to improved clinical quality, safety, and effectiveness within the inpatient hospital setting. This collaborative network has defined specific measurement indicators in an attempt to examine the existence, timing, and level of improvements in health outcomes that can be derived from IT investment. These indicators are in three areas: (1) IT costs (which includes both initial and ongoing investment), (2) IT infusion (ie, system availability, adoption, and deployment), and (3) health performance (eg, clinical efficacy, efficiency, quality, and effectiveness). Herein, we outline the theoretical framework, the methodology employed to create the metrics, and the benefits that can be obtained.

Model driven development of clinical information sytems using openEHR.

PubMed

Atalag, Koray; Yang, Hong Yul; Tempero, Ewan; Warren, Jim

2011-01-01

openEHR and the recent international standard (ISO 13606) defined a model driven software development methodology for health information systems. However there is little evidence in the literature describing implementation; especially for desktop clinical applications. This paper presents an implementation pathway using .Net/C# technology for Microsoft Windows desktop platforms. An endoscopy reporting application driven by openEHR Archetypes and Templates has been developed. A set of novel GUI directives has been defined and presented which guides the automatic graphical user interface generator to render widgets properly. We also reveal the development steps and important design decisions; from modelling to the final software product. This might provide guidance for other developers and form evidence required for the adoption of these standards for vendors and national programs alike.

Awake surgery between art and science. Part II: language and cognitive mapping

PubMed Central

Talacchi, Andrea; Santini, Barbara; Casartelli, Marilena; Monti, Alessia; Capasso, Rita; Miceli, Gabriele

Summary Direct cortical and subcortical stimulation has been claimed to be the gold standard for exploring brain function. In this field, efforts are now being made to move from intraoperative naming-assisted surgical resection towards the use of other language and cognitive tasks. However, before relying on new protocols and new techniques, we need a multi-staged system of evidence (low and high) relating to each step of functional mapping and its clinical validity. In this article we examine the possibilities and limits of brain mapping with the aid of a visual object naming task and various other tasks used to date. The methodological aspects of intraoperative brain mapping, as well as the clinical and operative settings, were discussed in Part I of this review. PMID:24139658

Reflecting on the methodological challenges of recruiting to a United Kingdom-wide, multi-centre, randomised controlled trial in gynaecology outpatient settings.

PubMed

Dickson, Sylvia; Logan, Janet; Hagen, Suzanne; Stark, Diane; Glazener, Cathryn; McDonald, Alison M; McPherson, Gladys

2013-11-15

Successful recruitment of participants to any trial is central to its success. Trial results are routinely published, and recruitment is often cited to be slower and more difficult than anticipated. This article reflects on the methodological challenges of recruiting women with prolapse attending United Kingdom (UK) gynaecology outpatient clinics to a multi-centre randomised controlled trial (RCT) of physiotherapy, and the systems put in place in an attempt to address them. Gynaecology outpatients with symptomatic prolapse were to be recruited over a 16-month period from 14 UK hospitals and one New Zealand hospital. Eligible women were informed about the trial by their gynaecologist and informed consent was obtained by the central trial office. Recruitment difficulties were encountered early on, and a number of strategies were employed to try to improve recruitment. Some strategies were more successful than others and they differed in the resources required. Actions that facilitated recruitment included increasing recruiting centres to 23 UK and two international hospitals, good centre support, using processes embedded in clinical practice, and good communication between the trial office, collaborators and participants. Collaborator incentives, whereby staff involved received the benefit immediately, were more successful than a nominal monetary payment per woman randomised. Barriers to recruitment included fewer eligible women than anticipated, patient's preference to receive active treatment rather than allocation to the control group, lack of support staff and high staff turnover. Geographical variations in Primary Care Trust Research Management and Governance approval systems and general practitioner (GP) referral procedures also impacted negatively on recruitment. Our article reflects on the methodological challenges of recruiting to a multi-centre RCT in a UK gynaecology setting. Effective interventions included increasing the number of recruiting centres and providing collaborator incentives. Barriers to recruitment included fewer eligible women than anticipated, patient's preference to be allocated to the treatment group, lack of support staff, and variations in approval systems and GP referral procedures. To improve the evidence base on clinical trial recruitment, trialists need to publish their experiences and lessons learned. Future RCTs should evaluate, where possible, the effect of strategies designed to improve recruitment and retention. Current Controlled Trials ISRCTN35911035.

Reflecting on the methodological challenges of recruiting to a United Kingdom-wide, multi-centre, randomised controlled trial in gynaecology outpatient settings

PubMed Central

2013-01-01

Background Successful recruitment of participants to any trial is central to its success. Trial results are routinely published, and recruitment is often cited to be slower and more difficult than anticipated. This article reflects on the methodological challenges of recruiting women with prolapse attending United Kingdom (UK) gynaecology outpatient clinics to a multi-centre randomised controlled trial (RCT) of physiotherapy, and the systems put in place in an attempt to address them. Methods Gynaecology outpatients with symptomatic prolapse were to be recruited over a 16-month period from 14 UK hospitals and one New Zealand hospital. Eligible women were informed about the trial by their gynaecologist and informed consent was obtained by the central trial office. Recruitment difficulties were encountered early on, and a number of strategies were employed to try to improve recruitment. Results Some strategies were more successful than others and they differed in the resources required. Actions that facilitated recruitment included increasing recruiting centres to 23 UK and two international hospitals, good centre support, using processes embedded in clinical practice, and good communication between the trial office, collaborators and participants. Collaborator incentives, whereby staff involved received the benefit immediately, were more successful than a nominal monetary payment per woman randomised. Barriers to recruitment included fewer eligible women than anticipated, patient’s preference to receive active treatment rather than allocation to the control group, lack of support staff and high staff turnover. Geographical variations in Primary Care Trust Research Management and Governance approval systems and general practitioner (GP) referral procedures also impacted negatively on recruitment. Conclusions Our article reflects on the methodological challenges of recruiting to a multi-centre RCT in a UK gynaecology setting. Effective interventions included increasing the number of recruiting centres and providing collaborator incentives. Barriers to recruitment included fewer eligible women than anticipated, patient’s preference to be allocated to the treatment group, lack of support staff, and variations in approval systems and GP referral procedures. To improve the evidence base on clinical trial recruitment, trialists need to publish their experiences and lessons learned. Future RCTs should evaluate, where possible, the effect of strategies designed to improve recruitment and retention. Trial registration Current Controlled Trials ISRCTN35911035 PMID:24228935

Using lean manufacturing principles to evaluate wait times for HIV-positive patients in an urban clinic in Kenya.

PubMed

Monroe-Wise, Aliza; Reisner, Elizabeth; Sherr, Kenneth; Ojakaa, David; Mbau, Lilian; Kisia, Paul; Muhula, Samuel; Farquhar, Carey

2017-12-01

As human immunodeficiency virus (HIV) treatment programs expand in Africa, delivery systems must be strengthened to support patient retention. Clinic characteristics may affect retention, but a relationship between clinic flow and attrition is not established. This project characterized HIV patient experience and flow in an urban Kenyan clinic to understand how these may affect retention. We used Toyota's lean manufacturing principles to guide data collection and analysis. Clinic flow was evaluated using value stream mapping and time and motion techniques. Clinic register data were analyzed. Two focus group discussions were held to characterize HIV patient experience. Results were shared with clinic staff. Wait times in the clinic were highly variable. We identified four main barriers to patient flow: inconsistent patient arrivals, inconsistent staffing, filing system defects, and serving patients out of order. Focus group participants explained how clinic operations affected their ability to engage in care. Clinic staff were eager to discuss the problems identified and identified numerous low-cost potential solutions. Lean manufacturing methodologies can guide efficiency interventions in low-resource healthcare settings. Using lean techniques, we identified bottlenecks to clinic flow and low-cost solutions to improve wait times. Improving flow may result in increased patient satisfaction and retention.

Pharmacogenomic knowledge representation, reasoning and genome-based clinical decision support based on OWL 2 DL ontologies.

PubMed

Samwald, Matthias; Miñarro Giménez, Jose Antonio; Boyce, Richard D; Freimuth, Robert R; Adlassnig, Klaus-Peter; Dumontier, Michel

2015-02-22

Every year, hundreds of thousands of patients experience treatment failure or adverse drug reactions (ADRs), many of which could be prevented by pharmacogenomic testing. However, the primary knowledge needed for clinical pharmacogenomics is currently dispersed over disparate data structures and captured in unstructured or semi-structured formalizations. This is a source of potential ambiguity and complexity, making it difficult to create reliable information technology systems for enabling clinical pharmacogenomics. We developed Web Ontology Language (OWL) ontologies and automated reasoning methodologies to meet the following goals: 1) provide a simple and concise formalism for representing pharmacogenomic knowledge, 2) finde errors and insufficient definitions in pharmacogenomic knowledge bases, 3) automatically assign alleles and phenotypes to patients, 4) match patients to clinically appropriate pharmacogenomic guidelines and clinical decision support messages and 5) facilitate the detection of inconsistencies and overlaps between pharmacogenomic treatment guidelines from different sources. We evaluated different reasoning systems and test our approach with a large collection of publicly available genetic profiles. Our methodology proved to be a novel and useful choice for representing, analyzing and using pharmacogenomic data. The Genomic Clinical Decision Support (Genomic CDS) ontology represents 336 SNPs with 707 variants; 665 haplotypes related to 43 genes; 22 rules related to drug-response phenotypes; and 308 clinical decision support rules. OWL reasoning identified CDS rules with overlapping target populations but differing treatment recommendations. Only a modest number of clinical decision support rules were triggered for a collection of 943 public genetic profiles. We found significant performance differences across available OWL reasoners. The ontology-based framework we developed can be used to represent, organize and reason over the growing wealth of pharmacogenomic knowledge, as well as to identify errors, inconsistencies and insufficient definitions in source data sets or individual patient data. Our study highlights both advantages and potential practical issues with such an ontology-based approach.

Methodological aspects of clinical trials in tinnitus: A proposal for an international standard

PubMed Central

Landgrebe, Michael; Azevedo, Andréia; Baguley, David; Bauer, Carol; Cacace, Anthony; Coelho, Claudia; Dornhoffer, John; Figueiredo, Ricardo; Flor, Herta; Hajak, Goeran; van de Heyning, Paul; Hiller, Wolfgang; Khedr, Eman; Kleinjung, Tobias; Koller, Michael; Lainez, Jose Miguel; Londero, Alain; Martin, William H.; Mennemeier, Mark; Piccirillo, Jay; De Ridder, Dirk; Rupprecht, Rainer; Searchfield, Grant; Vanneste, Sven; Zeman, Florian; Langguth, Berthold

2013-01-01

Chronic tinnitus is a common condition with a high burden of disease. While many different treatments are used in clinical practice, the evidence for the efficacy of these treatments is low and the variance of treatment response between individuals is high. This is most likely due to the great heterogeneity of tinnitus with respect to clinical features as well as underlying pathophysiological mechanisms. There is a clear need to find effective treatment options in tinnitus, however, clinical trials differ substantially with respect to methodological quality and design. Consequently, the conclusions that can be derived from these studies are limited and jeopardize comparison between studies. Here, we discuss our view of the most important aspects of trial design in clinical studies in tinnitus and make suggestions for an international methodological standard in tinnitus trials. We hope that the proposed methodological standard will stimulate scientific discussion and will help to improve the quality of trials in tinnitus. PMID:22789414

Intra-Articular Cellular Therapy for Osteoarthritis and Focal Cartilage Defects of the Knee: A Systematic Review of the Literature and Study Quality Analysis.

PubMed

Chahla, Jorge; Piuzzi, Nicolas S; Mitchell, Justin J; Dean, Chase S; Pascual-Garrido, Cecilia; LaPrade, Robert F; Muschler, George F

2016-09-21

Intra-articular cellular therapy injections constitute an appealing strategy that may modify the intra-articular milieu or regenerate cartilage in the settings of osteoarthritis and focal cartilage defects. However, little consensus exists regarding the indications for cellular therapies, optimal cell sources, methods of preparation and delivery, or means by which outcomes should be reported. We present a systematic review of the current literature regarding the safety and efficacy of cellular therapy delivered by intra-articular injection in the knee that provided a Level of Evidence of III or higher. A total of 420 papers were screened. Methodological quality was assessed using a modified Coleman methodology score. Only 6 studies (4 Level II and 2 Level III) met the criteria to be included in this review; 3 studies were on treatment of osteoarthritis and 3 were on treatment of focal cartilage defects. These included 4 randomized controlled studies without blinding, 1 prospective cohort study, and 1 retrospective therapeutic case-control study. The studies varied widely with respect to cell sources, cell characterization, adjuvant therapies, and assessment of outcomes. Outcome was reported in a total of 300 knees (124 in the osteoarthritis studies and 176 in the cartilage defect studies). Mean follow-up was 21.0 months (range, 12 to 36 months). All studies reported improved outcomes with intra-articular cellular therapy and no major adverse events. The mean modified Coleman methodology score was 59.1 ± 16 (range, 32 to 82). The studies of intra-articular cellular therapy injections for osteoarthritis and focal cartilage defects in the human knee suggested positive results with respect to clinical improvement and safety. However, the improvement was modest and a placebo effect cannot be disregarded. The overall quality of the literature was poor, and the methodological quality was fair, even among Level-II and III studies. Effective clinical assessment and optimization of injection therapies will demand greater attention to study methodology, including blinding; standardized quantitative methods for cell harvesting, processing, characterization, and delivery; and standardized reporting of clinical and structural outcomes. Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence. Copyright © 2016 by The Journal of Bone and Joint Surgery, Incorporated.

Clinical Criteria Versus a Possible Research Case Definition in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis.

PubMed

Jason, Leonard A; McManimen, Stephanie; Sunnquist, Madison; Newton, Julia L; Strand, Elin Bolle

2017-01-01

The Institute of Medicine (IOM) recently developed clinical criteria for what had been known as chronic fatigue syndrome (CFS). Given the broad nature of the clinical IOM criteria, there is a need for a research definition that would select a more homogenous and impaired group of patients than the IOM clinical criteria. At the present time, it is unclear what will serve as the research definition. The current study focused on a research definition which selected homebound individuals who met the four IOM criteria, excluding medical and psychiatric co-morbidities. Our research criteria were compared to those participants meeting the IOM criteria. Those not meeting either of these criteria sets were placed in a separate group defined by 6 or more months of fatigue. Data analyzed were from the DePaul Symptom Questionnaire and the SF-36. Due to unequal sample sizes and variances, Welch's F tests and Games-Howell post hoc tests were conducted. Using a large database of over 1,000 patients from several countries, we found that those meeting a more restrictive research definition were even more impaired and more symptomatic than those meeting criteria for the other two groups. Deciding on a particular research case definition would allow researchers to select more comparable patient samples across settings, and this would represent one of the most significant methodologic advances for this field of study.

Improvement of learning domains of nursing students with the use of authentic assessment pedagogy in clinical practice.

PubMed

Chong, Edmund Jun Meng; Lim, Jessica Shih Wei; Liu, Yuchan; Lau, Yvonne Yen Lin; Wu, Vivien Xi

2016-09-01

With evolving healthcare demands, nursing educators need to constantly review their teaching methodologies in order to enhance learners' knowledge and competency of skills in the clinical settings. Learning is an active process in which meaning is accomplished on the basis of experience and that authentic assessment pedagogy will enable nursing students to play an active part in their learning. The study was conducted with an aim to examine nursing students' learning domains through the introduction of the authentic assessment pedagogy during their clinical practice. A quasi-experimental study (n = 54) was conducted over a period of 10 weeks at a local tertiary hospital. The experimental group was exposed to the authentic assessment pedagogy and were taught to use the assessment rubrics as an instrument to help enhance their learning. Students were assessed and scored according to the assessment rubrics, which were categorized into four domains; cognitive, psychomotor, affective and critical thinking abilities. The findings indicated that an overall score for the four domains between the experimental and control groups were significant, with p value of <0.05. Critical thinking scores were indicative of consistent improvement within the experimental group. The findings confirmed that learning outcomes of the nursing students were enhanced through the early introduction of the authentic assessment pedagogy in the clinical setting. Copyright © 2016 Elsevier Ltd. All rights reserved.

A core outcome set for clinical trials on non-specific low back pain: study protocol for the development of a core domain set.

PubMed

Chiarotto, Alessandro; Terwee, Caroline B; Deyo, Richard A; Boers, Maarten; Lin, Chung-Wei Christine; Buchbinder, Rachelle; Corbin, Terry P; Costa, Leonardo O P; Foster, Nadine E; Grotle, Margreth; Koes, Bart W; Kovacs, Francisco M; Maher, Chris G; Pearson, Adam M; Peul, Wilco C; Schoene, Mark L; Turk, Dennis C; van Tulder, Maurits W; Ostelo, Raymond W

2014-12-26

Low back pain (LBP) is one of the most disabling and costly disorders affecting modern society, and approximately 90% of patients are labelled as having non-specific LBP (NSLBP). Several interventions for patients with NSLBP have been assessed in clinical trials, but heterogeneous reporting of outcomes in these trials has hindered comparison of results and performance of meta-analyses. Moreover, there is a risk of selective outcome reporting bias. To address these issues, the development of a core outcome set (COS) that should be measured in all clinical trials for a specific health condition has been recommended. A standardized set of outcomes for LBP was proposed in 1998, however, with evolution in COS development methodology, new instruments, interventions, and understanding of measurement properties, it is appropriate to update that proposal. This protocol describes the methods used in the initial step in developing a COS for NSLBP, namely, establishing a core domain set that should be measured in all clinical trials. An International Steering Committee including researchers, clinicians, and patient representatives from four continents was formed to guide the development of this COS. The approach of initiatives like Core Outcome Measures in Effectiveness Trials (COMET) and Outcome Measures in Rheumatology (OMERACT) was followed. Participants were invited to participate in a Delphi study aimed at generating a consensus-based core domain set for NSLBP. A list of potential core domains was drafted and presented to the Delphi participants who were asked to judge which domains were core. Participant suggestions about overlap, aggregation, or addition of potential core domains were addressed during the study. The patients' responses were isolated to assess whether there was substantial disagreement with the rest of the Delphi panel. A priori thresholds for consensus were established before each Delphi round. All participants' responses were analysed from a quantitative and qualitative perspective to ascertain that no substantial discrepancies between the two approaches emerged. We present the initial step in developing a COS for NSLBP. The next step will be to determine which measurement instruments adequately cover the domains.

Anion gap as a prognostic tool for risk stratification in critically ill patients - a systematic review and meta-analysis.

PubMed

Glasmacher, Stella Andrea; Stones, William

2016-08-30

Lactate concentration is a robust predictor of mortality but in many low resource settings facilities for its analysis are not available. Anion gap (AG), calculated from clinical chemistry results, is a marker of metabolic acidosis and may be more easily obtained in such settings. In this systematic review and meta-analysis we investigated whether the AG predicts mortality in adult patients admitted to critical care settings. We searched Medline, Embase, Web of Science, Scopus, The Cochrane Library and regional electronic databases from inception until May 2016. Studies conducted in any clinical setting that related AG to in-hospital mortality, in-intensive care unit mortality, 31-day mortality or comparable outcome measures were eligible for inclusion. Methodological quality of included studies was assessed using the Quality in Prognostic Studies tool. Descriptive meta-analysis was performed and the I(2) test was used to quantify heterogeneity. Subgroup analysis was undertaken to identify potential sources of heterogeneity between studies. Nineteen studies reporting findings in 12,497 patients were included. Overall, quality of studies was poor and most studies were rated as being at moderate or high risk of attrition bias and confounding. There was substantial diversity between studies with regards to clinical setting, age and mortality rates of patient cohorts. High statistical heterogeneity was found in the meta-analyses of area under the ROC curve (I(2) = 99 %) and mean difference (I(2) = 97 %) for the observed AG. Three studies reported good discriminatory power of the AG to predict mortality and were responsible for a large proportion of statistical heterogeneity. The remaining 16 studies reported poor to moderate ability of the AG to predict mortality. Subgroup analysis suggested that intravenous fluids affect the ability of the AG to predict mortality. Based on the limited quality of available evidence, a single AG measurement cannot be recommended for risk stratification in critically ill patients. The probable influence of intravenous fluids on AG levels renders the AG an impractical tool in clinical practice. Future research should focus on increasing the availability of lactate monitoring in low resource settings. CRD42015015249 . Registered on 4th February 2015.

Comparative effectiveness research for the clinician researcher: a framework for making a methodological design choice.

PubMed

Williams, Cylie M; Skinner, Elizabeth H; James, Alicia M; Cook, Jill L; McPhail, Steven M; Haines, Terry P

2016-08-17

Comparative effectiveness research compares two active forms of treatment or usual care in comparison with usual care with an additional intervention element. These types of study are commonly conducted following a placebo or no active treatment trial. Research designs with a placebo or non-active treatment arm can be challenging for the clinician researcher when conducted within the healthcare environment with patients attending for treatment.A framework for conducting comparative effectiveness research is needed, particularly for interventions for which there are no strong regulatory requirements that must be met prior to their introduction into usual care. We argue for a broader use of comparative effectiveness research to achieve translatable real-world clinical research. These types of research design also affect the rapid uptake of evidence-based clinical practice within the healthcare setting.This framework includes questions to guide the clinician researcher into the most appropriate trial design to measure treatment effect. These questions include consideration given to current treatment provision during usual care, known treatment effectiveness, side effects of treatments, economic impact, and the setting in which the research is being undertaken.

A multisite blinded study for the detection of BRAF mutations in formalin-fixed, paraffin-embedded malignant melanoma

PubMed Central

Richter, Anna; Grieu, Fabienne; Carrello, Amerigo; Amanuel, Benhur; Namdarian, Kateh; Rynska, Aleksandra; Lucas, Amanda; Michael, Victoria; Bell, Anthony; Fox, Stephen B.; Hewitt, Chelsee A.; Do, Hongdo; McArthur, Grant A.; Wong, Stephen Q.; Dobrovic, Alexander; Iacopetta, Barry

2013-01-01

Melanoma patients with BRAF mutations respond to treatment with vemurafenib, thus creating a need for accurate testing of BRAF mutation status. We carried out a blinded study to evaluate various BRAF mutation testing methodologies in the clinical setting. Formalin-fixed, paraffin-embedded melanoma samples were macrodissected before screening for mutations using Sanger sequencing, single-strand conformation analysis (SSCA), high resolution melting analysis (HRM) and competitive allele-specific TaqMan® PCR (CAST-PCR). Concordance of 100% was observed between the Sanger sequencing, SSCA and HRM techniques. CAST-PCR gave rapid and accurate results for the common V600E and V600K mutations, however additional assays are required to detect rarer BRAF mutation types found in 3–4% of melanomas. HRM and SSCA followed by Sanger sequencing are effective two-step strategies for the detection of BRAF mutations in the clinical setting. CAST-PCR was useful for samples with low tumour purity and may also be a cost-effective and robust method for routine diagnostics. PMID:23584600

Longitudinal treatment of cleft lip and palate in developing countries: dentistry as part of a multidisciplinary endeavor.

PubMed

Lee, Cameron C Y; Jagtap, Rasika R; Deshpande, Gaurav S

2014-09-01

Cleft lip and palate affects roughly 1 in 600 children and predisposes patients to a lifetime of functional and esthetic discrepancies. Disparities in access as well as quality of care exist worldwide, with many children in developing countries unable to receive treatment. In the late 20th century, humanitarian medical missions emerged as a means of delivering surgical expertise to patients in resource-limited settings. These early missions took on a patient-centered approach focused solely on cleft repair, with little emphasis on treating the dental abnormalities that arose after the initial surgery. However, modern cleft care is characterized by a multidisciplinary, team-based approach with significant dental involvement. Recent cleft lip and palate endeavors have shifted from a mission-based approach to a developmental approach facilitating growth of an independent care center. This strategy focuses on creating an institution with expanded access to dental services, thus facilitating the long-term treatment inherent in modern cleft care. One clinic in a developing country that has experienced successful transitioning from a mission site to an independent craniofacial clinic is Operation Smile's Cleft Comprehensive Care Clinic in Guwahati, India. This article will summarize the rationale and planning of the clinic, underscore the team-based approach required in longitudinal treatment of cleft lip and palate, and demonstrate how treatment methodology may differ in resource-limited settings by outlining the therapeutic considerations of each provider in the Guwahati Clinic.

An academic-health service partnership in nursing: lessons from the field.

PubMed

Granger, Bradi B; Prvu-Bettger, Janet; Aucoin, Julia; Fuchs, Mary Ann; Mitchell, Pamela H; Holditch-Davis, Diane; Roth, Deborah; Califf, Robert M; Gilliss, Catherine L

2012-03-01

To describe the development of an academic-health services partnership undertaken to improve use of evidence in clinical practice. Academic health science schools and health service settings share common elements of their missions: to educate, participate in research, and excel in healthcare delivery, but differences in the business models, incentives, and approaches to problem solving can lead to differences in priorities. Thus, academic and health service settings do not naturally align their leadership structures or work processes. We established a common commitment to accelerate the appropriate use of evidence in clinical practice and created an organizational structure to optimize opportunities for partnering that would leverage shared resources to achieve our goal. A jointly governed and funded institute integrated existing activities from the academic and service sectors. Additional resources included clinical staff and student training and mentoring, a pilot research grant-funding program, and support to access existing data. Emergent developments include an appreciation for a wider range of investigative methodologies and cross-disciplinary teams with skills to integrate research in daily practice and improve patient outcomes. By developing an integrated leadership structure and commitment to shared goals, we developed a framework for integrating academic and health service resources, leveraging additional resources, and forming a mutually beneficial partnership to improve clinical outcomes for patients. Structurally integrated academic-health service partnerships result in improved evidence-based patient care delivery and in a stronger foundation for generating new clinical knowledge, thus improving patient outcomes. © 2012 Sigma Theta Tau International.

Health Care Infrastructure for Financially Sustainable Clinical Genomics.

PubMed

Lennerz, Jochen K; McLaughlin, Heather M; Baron, Jason M; Rasmussen, David; Sumbada Shin, Meini; Berners-Lee, Nancy; Miller Batten, Julie; Swoboda, Kathryn J; Gala, Manish K; Winter, Harland S; Schmahmann, Jeremy D; Sweetser, David A; Boswell, Marianne; Pacula, Maciej; Stenzinger, Albrecht; Le, Long P; Hynes, William; Rehm, Heidi L; Klibanski, Anne; Black-Schaffer, Stephen W; Golden, Jeffrey A; Louis, David N; Weiss, Scott T; Iafrate, A John

2016-09-01

Next-generation sequencing has evolved technically and economically into the method of choice for interrogating the genome in cancer and inherited disorders. The introduction of procedural code sets for whole-exome and genome sequencing is a milestone toward financially sustainable clinical implementation; however, achieving reimbursement is currently a major challenge. As part of a prospective quality-improvement initiative to implement the new code sets, we adopted Agile, a development methodology originally devised in software development. We implemented eight functionally distinct modules (request review, cost estimation, preauthorization, accessioning, prebilling, testing, reporting, and reimbursement consultation) and obtained feedback via an anonymous survey. We managed 50 clinical requests (January to June 2015). The fraction of pursued-to-requested cases (n = 15/50; utilization management fraction, 0.3) aimed for a high rate of preauthorizations. In 13 of 15 patients the insurance plan required preauthorization, which we obtained in 70% and ultimately achieved reimbursement in 50%. Interoperability enabled assessment of 12 different combinations of modules that underline the importance of an adaptive workflow and policy tailoring to achieve higher yields of reimbursement. The survey confirmed a positive attitude toward self-organizing teams. We acknowledge the individuals and their interactions and termed the infrastructure: human pipeline. Nontechnical barriers currently are limiting the scope and availability of clinical genomic sequencing. The presented human pipeline is one approach toward long-term financial sustainability of clinical genomics. Copyright © 2016 American Society for Investigative Pathology and the Association for Molecular Pathology. Published by Elsevier Inc. All rights reserved.

EQ-5D in Central and Eastern Europe: 2000-2015.

PubMed

Rencz, Fanni; Gulácsi, László; Drummond, Michael; Golicki, Dominik; Prevolnik Rupel, Valentina; Simon, Judit; Stolk, Elly A; Brodszky, Valentin; Baji, Petra; Závada, Jakub; Petrova, Guenka; Rotar, Alexandru; Péntek, Márta

2016-11-01

Cost per quality-adjusted life year data are required for reimbursement decisions in many Central and Eastern European (CEE) countries. EQ-5D is by far the most commonly used instrument to generate utility values in CEE. This study aims to systematically review the literature on EQ-5D from eight CEE countries. An electronic database search was performed up to 1 July 2015 to identify original EQ-5D studies from the countries of interest. We analysed the use of EQ-5D with respect to clinical areas, methodological rigor, population norms and value sets. We identified 143 studies providing 152 country-specific results with a total sample size of 81,619: Austria (n = 11), Bulgaria (n = 6), Czech Republic (n = 18), Hungary (n = 47), Poland (n = 51), Romania (n = 2), Slovakia (n = 3) and Slovenia (n = 14). Cardiovascular (21 %), neurologic (17 %), musculoskeletal (15 %) and endocrine, nutritional and metabolic diseases (13 %) were the most frequently studied clinical areas. Overall, 112 (78 %) of the studies reported EQ VAS results and 86 (60 %) EQ-5D index scores, of which 27 (31 %) did not specify the applied tariff. Hungary, Poland and Slovenia have population norms. Poland and Slovenia also have a national value set. Increasing use of EQ-5D is observed throughout CEE. The spread of health technology assessment activities in countries seems to be reflected in the number of EQ-5D studies. However, improvement in informed use and methodological quality of reporting is needed. In jurisdictions where no national value set is available, in order to ensure comparability we recommend to apply the most frequently used UK tariff. Regional collaboration between CEE countries should be strengthened.

Developing Canadian physician: the quest for leadership effectiveness.

PubMed

Comber, Scott; Wilson, Lisette; Crawford, Kyle C

2016-07-04

Purpose The purpose of this study is to discern the physicians' perception of leadership effectiveness in their clinical and non-clinical roles (leadership) by identifying their political skill levels. Design/methodology/approach A sample of 209 Canadian physicians was surveyed using the Political Skills Inventory (PSI) during the period 2012-2014. The PSI was chosen because it assesses leadership effectiveness on four dimensions: social astuteness, interpersonal influence, networking ability and apparent authenticity. Findings Physicians in clinical roles' PSI scores were significantly lower in all four PSI dimensions when compared to all other physicians in non-clinical roles, with the principal difference being in their networking abilities. Practical implications More emphasis is needed on educating and training physicians, specifically in the areas of political skills, in current clinical roles if they are to assume leadership roles and be effective. Originality/value Although this study is located in Canada, the study design and associated findings may have implications to other areas and countries wanting to increase physician leadership effectiveness. Further, replication of this study in other settings may provide insight into the future design of physician leadership training curriculum.

Economic evaluation of nurse practitioner and clinical nurse specialist roles: A methodological review.

PubMed

Lopatina, Elena; Donald, Faith; DiCenso, Alba; Martin-Misener, Ruth; Kilpatrick, Kelley; Bryant-Lukosius, Denise; Carter, Nancy; Reid, Kim; Marshall, Deborah A

2017-07-01

Advanced practice nurses (e.g., nurse practitioners and clinical nurse specialists) have been introduced internationally to increase access to high quality care and to tackle increasing health care expenditures. While randomised controlled trials and systematic reviews have demonstrated the effectiveness of nurse practitioner and clinical nurse specialist roles, their cost-effectiveness has been challenged. The poor quality of economic evaluations of these roles to date raises the question of whether current economic evaluation guidelines are adequate when examining their cost-effectiveness. To examine whether current guidelines for economic evaluation are appropriate for economic evaluations of nurse practitioner and clinical nurse specialist roles. Our methodological review was informed by a qualitative synthesis of four sources of information: 1) narrative review of literature reviews and discussion papers on economic evaluation of advanced practice nursing roles; 2) quality assessment of economic evaluations of nurse practitioner and clinical nurse specialist roles alongside randomised controlled trials; 3) review of guidelines for economic evaluation; and, 4) input from an expert panel. The narrative literature review revealed several challenges in economic evaluations of advanced practice nursing roles (e.g., complexity of the roles, variability in models and practice settings where the roles are implemented, and impact on outcomes that are difficult to measure). The quality assessment of economic evaluations of nurse practitioner and clinical nurse specialist roles alongside randomised controlled trials identified methodological limitations of these studies. When we applied the Guidelines for the Economic Evaluation of Health Technologies: Canada to the identified challenges and limitations, discussed those with experts and qualitatively synthesized all findings, we concluded that standard guidelines for economic evaluation are appropriate for economic evaluations of nurse practitioner and clinical nurse specialist roles and should be routinely followed. However, seven out of 15 current guideline sections (describing a decision problem, choosing type of economic evaluation, selecting comparators, determining the study perspective, estimating effectiveness, measuring and valuing health, and assessing resource use and costs) may require additional role-specific considerations to capture costs and effects of these roles. Current guidelines for economic evaluation should form the foundation for economic evaluations of nurse practitioner and clinical nurse specialist roles. The proposed role-specific considerations, which clarify application of standard guidelines sections to economic evaluation of nurse practitioner and clinical nurse specialist roles, may strengthen the quality and comprehensiveness of future economic evaluations of these roles. Copyright © 2017 Elsevier Ltd. All rights reserved.

Connective tissue disease related interstitial lung diseases and idiopathic pulmonary fibrosis: provisional core sets of domains and instruments for use in clinical trials.

PubMed

Saketkoo, Lesley Ann; Mittoo, Shikha; Huscher, Dörte; Khanna, Dinesh; Dellaripa, Paul F; Distler, Oliver; Flaherty, Kevin R; Frankel, Sid; Oddis, Chester V; Denton, Christopher P; Fischer, Aryeh; Kowal-Bielecka, Otylia M; LeSage, Daphne; Merkel, Peter A; Phillips, Kristine; Pittrow, David; Swigris, Jeffrey; Antoniou, Katerina; Baughman, Robert P; Castelino, Flavia V; Christmann, Romy B; Christopher-Stine, Lisa; Collard, Harold R; Cottin, Vincent; Danoff, Sonye; Highland, Kristin B; Hummers, Laura; Shah, Ami A; Kim, Dong Soon; Lynch, David A; Miller, Frederick W; Proudman, Susanna M; Richeldi, Luca; Ryu, Jay H; Sandorfi, Nora; Sarver, Catherine; Wells, Athol U; Strand, Vibeke; Matteson, Eric L; Brown, Kevin K; Seibold, James R

2014-05-01

Clinical trial design in interstitial lung diseases (ILDs) has been hampered by lack of consensus on appropriate outcome measures for reliably assessing treatment response. In the setting of connective tissue diseases (CTDs), some measures of ILD disease activity and severity may be confounded by non-pulmonary comorbidities. The Connective Tissue Disease associated Interstitial Lung Disease (CTD-ILD) working group of Outcome Measures in Rheumatology-a non-profit international organisation dedicated to consensus methodology in identification of outcome measures-conducted a series of investigations which included a Delphi process including >248 ILD medical experts as well as patient focus groups culminating in a nominal group panel of ILD experts and patients. The goal was to define and develop a consensus on the status of outcome measure candidates for use in randomised controlled trials in CTD-ILD and idiopathic pulmonary fibrosis (IPF). A core set comprising specific measures in the domains of lung physiology, lung imaging, survival, dyspnoea, cough and health-related quality of life is proposed as appropriate for consideration for use in a hypothetical 1-year multicentre clinical trial for either CTD-ILD or IPF. As many widely used instruments were found to lack full validation, an agenda for future research is proposed. Identification of consensus preliminary domains and instruments to measure them was attained and is a major advance anticipated to facilitate multicentre RCTs in the field.

Connective tissue disease related interstitial lung diseases and idiopathic pulmonary fibrosis: provisional core sets of domains and instruments for use in clinical trials

PubMed Central

Saketkoo, Lesley Ann; Mittoo, Shikha; Huscher, Dörte; Khanna, Dinesh; Dellaripa, Paul F; Distler, Oliver; Flaherty, Kevin R; Frankel, Sid; Oddis, Chester V; Denton, Christopher P; Fischer, Aryeh; Kowal-Bielecka, Otylia M; LeSage, Daphne; Merkel, Peter A; Phillips, Kristine; Pittrow, David; Swigris, Jeffrey; Antoniou, Katerina; Baughman, Robert P; Castelino, Flavia V; Christmann, Romy B; Christopher-Stine, Lisa; Collard, Harold R; Cottin, Vincent; Danoff, Sonye; Highland, Kristin B; Hummers, Laura; Shah, Ami A; Kim, Dong Soon; Lynch, David A; Miller, Frederick W; Proudman, Susanna M; Richeldi, Luca; Ryu, Jay H; Sandorfi, Nora; Sarver, Catherine; Wells, Athol U; Strand, Vibeke; Matteson, Eric L; Brown, Kevin K; Seibold, James R

2014-01-01

Rationale Clinical trial design in interstitial lung diseases (ILDs) has been hampered by lack of consensus on appropriate outcome measures for reliably assessing treatment response. In the setting of connective tissue diseases (CTDs), some measures of ILD disease activity and severity may be confounded by non-pulmonary comorbidities. Methods The Connective Tissue Disease associated Interstitial Lung Disease (CTD-ILD) working group of Outcome Measures in Rheumatology—a non-profit international organisation dedicated to consensus methodology in identification of outcome measures—conducted a series of investigations which included a Delphi process including >248 ILD medical experts as well as patient focus groups culminating in a nominal group panel of ILD experts and patients. The goal was to define and develop a consensus on the status of outcome measure candidates for use in randomised controlled trials in CTD-ILD and idiopathic pulmonary fibrosis (IPF). Results A core set comprising specific measures in the domains of lung physiology, lung imaging, survival, dyspnoea, cough and health-related quality of life is proposed as appropriate for consideration for use in a hypothetical 1-year multicentre clinical trial for either CTD-ILD or IPF. As many widely used instruments were found to lack full validation, an agenda for future research is proposed. Conclusion Identification of consensus preliminary domains and instruments to measure them was attained and is a major advance anticipated to facilitate multicentre RCTs in the field. PMID:24368713

Protocol for developing, disseminating and implementing a core outcome set for endometriosis.

PubMed

Hirsch, Martin; Duffy, James M N; Barker, Claire; Hummelshoj, Lone; Johnson, Neil P; Mol, Ben; Khan, Khalid S; Farquhar, Cindy

2016-12-21

Endometriosis is a common gynaecological disease characterised by pain and subfertility. Randomised controlled trials evaluating treatments for endometriosis have reported many different outcomes and outcome measures. This variation restricts effective data synthesis limiting the usefulness of research to inform clinical practice. To address these methodological concerns, we aim to develop, disseminate and implement a core outcome set for endometriosis engaging with key stakeholders, including healthcare professionals, researchers and women with endometriosis. An international steering group has been established, including healthcare professionals, researchers and patient representatives. Potential outcomes identified from a systematic review of the literature will be entered into a modified Delphi method. Key stakeholders will be invited to participate including healthcare professionals, researchers and women with endometriosis. Participants will be invited to score individual outcomes on a nine-point Likert scale anchored between 1 (not important) and 9 (critical). Repeated reflection and rescoring should promote whole and individual stakeholder group converge towards consensus, 'core', outcomes. High-quality outcome measures will be associated with core outcomes. The implementation of a core outcome set for endometriosis within future clinical trials, systematic reviews and clinical guidelines will enhance the availability of comparable data to facilitate evidence-based patient care. This study was prospectively registered with Core Outcome Measures in Effectiveness Trials Initiative; number: 691. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Clinical outcomes research in gynecologic oncology.

PubMed

Melamed, Alexander; Rauh-Hain, J Alejandro; Schorge, John O

2017-09-01

Clinical outcomes research seeks to understand the real-world manifestations of clinical care. In particular, outcomes research seeks to reveal the effects of pharmaceutical, procedural, and structural aspects of healthcare on patient outcomes, including mortality, disease control, toxicity, cost, and quality of life. Although outcomes research can utilize interventional study designs, insightful use of observational data is a defining feature of this field. Many questions in gynecologic oncology are not amenable to investigation in randomized clinical trials due to cost, feasibility, or ethical concerns. When a randomized trial is not practical or has not yet been conducted, well-designed observational studies have the potential to provide the best available evidence about the effects of clinical care. Such studies may use surveys, medical records, disease registries, and a variety of administrative data sources. Even when a randomized trial has been conducted, observational studies can be used to estimate the real-world effect of an intervention, which may differ from the results obtained in the controlled setting of a clinical trial. This article reviews the goals, methodologies, data sources, and limitations of clinical outcomes research, with a focus on gynecologic oncology. Copyright © 2017. Published by Elsevier Inc.

Methodological factors conducting research with incarcerated persons with diabetes.

PubMed

Reagan, Louise; Shelton, Deborah

2016-02-01

The aim of this study was to describe methodological issues specific to conducting research with incarcerated vulnerable populations who have diabetes. Much has been written about the ethical and logistical challenges of conducting research with vulnerable incarcerated populations. However, conducting research with incarcerated persons with diabetes is associated with additional issues related to research design, measurement, sampling and recruitment, and data collection procedures. A cross-sectional study examining the relationships of diabetes knowledge, illness representation and self-care behaviors with glycemic control in 124 incarcerated persons was conducted and serves as the basis for describing methodological factors for the conduct of research with an incarcerated population with diabetes. Within this incarcerated population with diabetes, sampling bias due to gender inequity, recruitment of participants not using insulin, self-reported vision impairment, and a lack of standardized instruments especially for measuring diabetes self-care were methodological challenges. Clinical factors that serve as potential barriers for study conduct were identified as risk for hypoglycemia due to insulin timing and other activities. Conducting research with incarcerated persons diagnosed with diabetes requires attention to a set of methodological concerns above and beyond that of the ethical and legal regulations for protecting the rights of this vulnerable population. To increase opportunities for conducting rigorous as well as facility- and patient-friendly research, researchers need to blend their knowledge of diabetes with an understanding of prison rules and routines. Copyright © 2015 Elsevier Inc. All rights reserved.

Precision and accuracy of clinical quantification of myocardial blood flow by dynamic PET: A technical perspective.

PubMed

Moody, Jonathan B; Lee, Benjamin C; Corbett, James R; Ficaro, Edward P; Murthy, Venkatesh L

2015-10-01

A number of exciting advances in PET/CT technology and improvements in methodology have recently converged to enhance the feasibility of routine clinical quantification of myocardial blood flow and flow reserve. Recent promising clinical results are pointing toward an important role for myocardial blood flow in the care of patients. Absolute blood flow quantification can be a powerful clinical tool, but its utility will depend on maintaining precision and accuracy in the face of numerous potential sources of methodological errors. Here we review recent data and highlight the impact of PET instrumentation, image reconstruction, and quantification methods, and we emphasize (82)Rb cardiac PET which currently has the widest clinical application. It will be apparent that more data are needed, particularly in relation to newer PET technologies, as well as clinical standardization of PET protocols and methods. We provide recommendations for the methodological factors considered here. At present, myocardial flow reserve appears to be remarkably robust to various methodological errors; however, with greater attention to and more detailed understanding of these sources of error, the clinical benefits of stress-only blood flow measurement may eventually be more fully realized.

The Business Case for Provider Participation in Clinical Trials Research: An Application to the National Cancer Institute's Community Clinical Oncology Program

PubMed Central

Song, Paula H.; Reiter, Kristin L.; Weiner, Bryan J.; Minasian, Lori; McAlearney, Ann Scheck

2012-01-01

Background Provider-based research networks (PBRNs) make clinical trials available in community-based practice settings, where most people receive their care, but provider participation requires both financial and in-kind contributions. Purpose This study explores whether providers believe there is a business case for participating in PBRNs and what factors contribute to the business case. Methodology/Approach We use a multiple case study methodology approach to examine the National Cancer Institute's Community Clinical Oncology Program, a longstanding federally funded PBRN. Interviews with 41 key informants across five sites, selected on the basis of organizational maturity, were conducted using a semi-structured interview guide. We analyzed interview transcripts using an iterative, deductive process to identify themes and subthemes in the data. Findings We found that a business case for provider participation in PBRNs may exist if both direct and indirect financial benefits are identified and included in the analysis, and if the time horizon is long enough to allow those benefits to be realized. We identified specific direct and indirect financial benefits that were perceived as important contributors to the business case and the perceived length of time required for a positive return to accrue. Practice Implications As the lack of a business case may result in provider reluctance to participate in PBRNs, knowledge of the benefits we identified may be crucial to encouraging and sustaining participation, thereby preserving patient access to innovative community-based treatments. The results are also relevant to federally-funded PBRNs outside of oncology or to providers considering participation in any clinical trials research. PMID:23044836

A clinically integrated curriculum in Evidence-based Medicine for just-in-time learning through on-the-job training: The EU-EBM project

PubMed Central

Coppus, Sjors FPJ; Emparanza, Jose I; Hadley, Julie; Kulier, Regina; Weinbrenner, Susanne; Arvanitis, Theodoros N; Burls, Amanda; Cabello, Juan B; Decsi, Tamas; Horvath, Andrea R; Kaczor, Marcin; Zanrei, Gianni; Pierer, Karin; Stawiarz, Katarzyna; Kunz, Regina; Mol, Ben WJ; Khan, Khalid S

2007-01-01

Background Over the last years key stake holders in the healthcare sector have increasingly recognised evidence based medicine (EBM) as a means to improving the quality of healthcare. However, there is considerable uncertainty about the best way to disseminate basic knowledge of EBM. As a result, huge variation in EBM educational provision, setting, duration, intensity, content, and teaching methodology exists across Europe and worldwide. Most courses for health care professionals are delivered outside the work context ('stand alone') and lack adaptation to the specific needs for EBM at the learners' workplace. Courses with modern 'adaptive' EBM teaching that employ principles of effective continuing education might fill that gap. We aimed to develop a course for post-graduate education which is clinically integrated and allows maximum flexibility for teachers and learners. Methods A group of experienced EBM teachers, clinical epidemiologists, clinicians and educationalists from institutions from eight European countries participated. We used an established methodology of curriculum development to design a clinically integrated EBM course with substantial components of e-learning. An independent European steering committee provided input into the process. Results We defined explicit learning objectives about knowledge, skills, attitudes and behaviour for the five steps of EBM. A handbook guides facilitator and learner through five modules with clinical and e-learning components. Focussed activities and targeted assignments round off the learning process, after which each module is formally assessed. Conclusion The course is learner-centred, problem-based, integrated with activities in the workplace and flexible. When successfully implemented, the course is designed to provide just-in-time learning through on-the-job-training, with the potential for teaching and learning to directly impact on practice. PMID:18042271

A clinically integrated curriculum in evidence-based medicine for just-in-time learning through on-the-job training: the EU-EBM project.

PubMed

Coppus, Sjors F P J; Emparanza, Jose I; Hadley, Julie; Kulier, Regina; Weinbrenner, Susanne; Arvanitis, Theodoros N; Burls, Amanda; Cabello, Juan B; Decsi, Tamas; Horvath, Andrea R; Kaczor, Marcin; Zanrei, Gianni; Pierer, Karin; Stawiarz, Katarzyna; Kunz, Regina; Mol, Ben W J; Khan, Khalid S

2007-11-27

Over the last years key stake holders in the healthcare sector have increasingly recognised evidence based medicine (EBM) as a means to improving the quality of healthcare. However, there is considerable uncertainty about the best way to disseminate basic knowledge of EBM. As a result, huge variation in EBM educational provision, setting, duration, intensity, content, and teaching methodology exists across Europe and worldwide. Most courses for health care professionals are delivered outside the work context ('stand alone') and lack adaptation to the specific needs for EBM at the learners' workplace. Courses with modern 'adaptive' EBM teaching that employ principles of effective continuing education might fill that gap. We aimed to develop a course for post-graduate education which is clinically integrated and allows maximum flexibility for teachers and learners. A group of experienced EBM teachers, clinical epidemiologists, clinicians and educationalists from institutions from eight European countries participated. We used an established methodology of curriculum development to design a clinically integrated EBM course with substantial components of e-learning. An independent European steering committee provided input into the process. We defined explicit learning objectives about knowledge, skills, attitudes and behaviour for the five steps of EBM. A handbook guides facilitator and learner through five modules with clinical and e-learning components. Focussed activities and targeted assignments round off the learning process, after which each module is formally assessed. The course is learner-centred, problem-based, integrated with activities in the workplace and flexible. When successfully implemented, the course is designed to provide just-in-time learning through on-the-job-training, with the potential for teaching and learning to directly impact on practice.

76 FR 23825 - Study Methodologies for Diagnostics in the Postmarket Setting; Public Workshop

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-28

... community on issues related to the studies and methodological approaches examining diagnostics in the... discuss a large number of methodological concerns at the workshop, including, but not limited to the...

Hypnotherapy for labor and birth.

PubMed

Beebe, Kathleen R

2014-01-01

Hypnotherapy is an integrative mind-body technique with therapeutic potential in various health care applications, including labor and birth. Evaluating the efficacy of this modality in controlled studies can be difficult, because of methodologic challenges, such as obtaining adequate sample sizes and standardizing experimental conditions. Women using hypnosis techniques for childbirth in hospital settings may face barriers related to caregiver resistance or institutional policies. The potential anxiolytic and analgesic effects of clinical hypnosis for childbirth merit further study. Nurses caring for women during labor and birth can increase their knowledge and skills with strategies for supporting hypnotherapeutic techniques. © 2014 AWHONN.

A novel approach to spinal 3-D kinematic assessment using inertial sensors: Towards effective quantitative evaluation of low back pain in clinical settings.

PubMed

Ashouri, Sajad; Abedi, Mohsen; Abdollahi, Masoud; Dehghan Manshadi, Farideh; Parnianpour, Mohamad; Khalaf, Kinda

2017-10-01

This paper presents a novel approach for evaluating LBP in various settings. The proposed system uses cost-effective inertial sensors, in conjunction with pattern recognition techniques, for identifying sensitive classifiers towards discriminate identification of LB patients. 24 healthy individuals and 28 low back pain patients performed trunk motion tasks in five different directions for validation. Four combinations of these motions were selected based on literature, and the corresponding kinematic data was collected. Upon filtering (4th order, low pass Butterworth filter) and normalizing the data, Principal Component Analysis was used for feature extraction, while Support Vector Machine classifier was applied for data classification. The results reveal that non-linear Kernel classification can be adequately employed for low back pain identification. Our preliminary results demonstrate that using a single inertial sensor placed on the thorax, in conjunction with a relatively simple test protocol, can identify low back pain with an accuracy of 96%, a sensitivity of %100, and specificity of 92%. While our approach shows promising results, further validation in a larger population is required towards using the methodology as a practical quantitative assessment tool for the detection of low back pain in clinical/rehabilitation settings. Copyright © 2017 Elsevier Ltd. All rights reserved.

42 CFR 441.472 - Budget methodology.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 4 2010-10-01 2010-10-01 false Budget methodology. 441.472 Section 441.472 Public... Self-Directed Personal Assistance Services Program § 441.472 Budget methodology. (a) The State shall set forth a budget methodology that ensures service authorization resides with the State and meets the...

Clinical use of quantitative cardiac perfusion PET: rationale, modalities and possible indications. Position paper of the Cardiovascular Committee of the European Association of Nuclear Medicine (EANM).

PubMed

Sciagrà, Roberto; Passeri, Alessandro; Bucerius, Jan; Verberne, Hein J; Slart, Riemer H J A; Lindner, Oliver; Gimelli, Alessia; Hyafil, Fabien; Agostini, Denis; Übleis, Christopher; Hacker, Marcus

2016-07-01

Until recently, PET was regarded as a luxurious way of performing myocardial perfusion scintigraphy, with excellent image quality and diagnostic capabilities that hardly justified the additional cost and procedural effort. Quantitative perfusion PET was considered a major improvement over standard qualitative imaging, because it allows the measurement of parameters not otherwise available, but for many years its use was confined to academic and research settings. In recent years, however, several factors have contributed to the renewal of interest in quantitative perfusion PET, which has become a much more readily accessible technique due to progress in hardware and the availability of dedicated and user-friendly platforms and programs. In spite of this evolution and of the growing evidence that quantitative perfusion PET can play a role in the clinical setting, there are not yet clear indications for its clinical use. Therefore, the Cardiovascular Committee of the European Association of Nuclear Medicine, starting from the experience of its members, decided to examine the current literature on quantitative perfusion PET to (1) evaluate the rationale for its clinical use, (2) identify the main methodological requirements, (3) identify the remaining technical difficulties, (4) define the most reliable interpretation criteria, and finally (5) tentatively delineate currently acceptable and possibly appropriate clinical indications. The present position paper must be considered as a starting point aiming to promote a wider use of quantitative perfusion PET and to encourage the conception and execution of the studies needed to definitely establish its role in clinical practice.

[Endovascular treatment in acute ischaemic stroke. A stroke care plan for the region of Madrid].

PubMed

Alonso de Leciñana, M; Díaz-Guzmán, J; Egido, J A; García Pastor, A; Martínez-Sánchez, P; Vivancos, J; Díez-Tejedor, E

2013-09-01

Endovascular therapies (intra-arterial thrombolysis and mechanical thrombectomy) after acute ischaemic stroke are being implemented in the clinical setting even as they are still being researched. Since we lack sufficient data to establish accurate evidence-based recommendations for use of these treatments, we must develop clinical protocols based on current knowledge and carefully monitor all procedures. After review of the literature and holding work sessions to reach a consensus among experts, we developed a clinical protocol including indications and contraindications for endovascular therapies use in acute ischaemic stroke. The protocol includes methodology recommendations for diagnosing and selecting patients, performing revascularisation procedures, and for subsequent patient management. Its objective is to increase the likelihood of efficacy and treatment benefit and minimise risk of complications and ineffective recanalisation. Based on an analysis of healthcare needs and available resources, a cooperative inter-hospital care system has been developed. This helps to ensure availability of endovascular therapies to all patients, a fast response time, and a good cost-to-efficacy ratio. It includes also a prospective register which serves to monitor procedures in order to identify any opportunities for improvement. Implementation of endovascular techniques for treating acute ischaemic stroke requires the elaboration of evidence-based clinical protocols and the establishment of appropriate cooperative healthcare networks guaranteeing both the availability and the quality of these actions. Such procedures must be monitored in order to improve methodology. Copyright © 2012 Sociedad Española de Neurología. Published by Elsevier Espana. All rights reserved.

Subgroup analyses in confirmatory clinical trials: time to be specific about their purposes.

PubMed

Tanniou, Julien; van der Tweel, Ingeborg; Teerenstra, Steven; Roes, Kit C B

2016-02-18

It is well recognized that treatment effects may not be homogeneous across the study population. Subgroup analyses constitute a fundamental step in the assessment of evidence from confirmatory (Phase III) clinical trials, where conclusions for the overall study population might not hold. Subgroup analyses can have different and distinct purposes, requiring specific design and analysis solutions. It is relevant to evaluate methodological developments in subgroup analyses against these purposes to guide health care professionals and regulators as well as to identify gaps in current methodology. We defined four purposes for subgroup analyses: (1) Investigate the consistency of treatment effects across subgroups of clinical importance, (2) Explore the treatment effect across different subgroups within an overall non-significant trial, (3) Evaluate safety profiles limited to one or a few subgroup(s), (4) Establish efficacy in the targeted subgroup when included in a confirmatory testing strategy of a single trial. We reviewed the methodology in line with this "purpose-based" framework. The review covered papers published between January 2005 and April 2015 and aimed to classify them in none, one or more of the aforementioned purposes. In total 1857 potentially eligible papers were identified. Forty-eight papers were selected and 20 additional relevant papers were identified from their references, leading to 68 papers in total. Nineteen were dedicated to purpose 1, 16 to purpose 4, one to purpose 2 and none to purpose 3. Seven papers were dedicated to more than one purpose, the 25 remaining could not be classified unambiguously. Purposes of the methods were often not specifically indicated, methods for subgroup analysis for safety purposes were almost absent and a multitude of diverse methods were developed for purpose (1). It is important that researchers developing methodology for subgroup analysis explicitly clarify the objectives of their methods in terms that can be understood from a patient's, health care provider's and/or regulator's perspective. A clear operational definition for consistency of treatment effects across subgroups is lacking, but is needed to improve the usability of subgroup analyses in this setting. Finally, methods to particularly explore benefit-risk systematically across subgroups need more research.

Use of standardised patients to assess quality of healthcare in Nairobi, Kenya: a pilot, cross-sectional study with international comparisons.

PubMed

Daniels, Benjamin; Dolinger, Amy; Bedoya, Guadalupe; Rogo, Khama; Goicoechea, Ana; Coarasa, Jorge; Wafula, Francis; Mwaura, Njeri; Kimeu, Redemptar; Das, Jishnu

2017-01-01

The quality of clinical care can be reliably measured in multiple settings using standardised patients (SPs), but this methodology has not been extensively used in Sub-Saharan Africa. This study validates the use of SPs for a variety of tracer conditions in Nairobi, Kenya, and provides new results on the quality of care in sampled primary care clinics. We deployed 14 SPs in private and public clinics presenting either asthma, child diarrhoea, tuberculosis or unstable angina. Case management guidelines and checklists were jointly developed with the Ministry of Health. We validated the SP method based on the ability of SPs to avoid detection or dangerous situations, without imposing a substantial time burden on providers. We also evaluated the sensitivity of quality measures to SP characteristics. We assessed quality of practice through adherence to guidelines and checklists for the entire sample, stratified by case and stratified by sector, and in comparison with previously published results from urban India, rural India and rural China. Across 166 interactions in 42 facilities, detection rates and exposure to unsafe conditions were both zero. There were no detected outcome correlations with SP characteristics that would bias the results. Across all four conditions, 53% of SPs were correctly managed with wide variation across tracer conditions. SPs paid 76% less in public clinics, but proportions of correct management were similar to private clinics for three conditions and higher for the fourth. Kenyan outcomes compared favourably with India and China in all but the angina case. The SP method is safe and effective in the urban Kenyan setting for the assessment of clinical practice. The pilot results suggest that public providers in this setting provide similar rates of correct management to private providers at significantly lower out-of-pocket costs for patients. However, comparisons across countries are sensitive to the tracer condition considered.

Use of standardised patients to assess quality of healthcare in Nairobi, Kenya: a pilot, cross-sectional study with international comparisons

PubMed Central

Daniels, Benjamin; Dolinger, Amy; Bedoya, Guadalupe; Rogo, Khama; Goicoechea, Ana; Coarasa, Jorge; Wafula, Francis; Mwaura, Njeri; Kimeu, Redemptar

2017-01-01

Introduction The quality of clinical care can be reliably measured in multiple settings using standardised patients (SPs), but this methodology has not been extensively used in Sub-Saharan Africa. This study validates the use of SPs for a variety of tracer conditions in Nairobi, Kenya, and provides new results on the quality of care in sampled primary care clinics. Methods We deployed 14 SPs in private and public clinics presenting either asthma, child diarrhoea, tuberculosis or unstable angina. Case management guidelines and checklists were jointly developed with the Ministry of Health. We validated the SP method based on the ability of SPs to avoid detection or dangerous situations, without imposing a substantial time burden on providers. We also evaluated the sensitivity of quality measures to SP characteristics. We assessed quality of practice through adherence to guidelines and checklists for the entire sample, stratified by case and stratified by sector, and in comparison with previously published results from urban India, rural India and rural China. Results Across 166 interactions in 42 facilities, detection rates and exposure to unsafe conditions were both zero. There were no detected outcome correlations with SP characteristics that would bias the results. Across all four conditions, 53% of SPs were correctly managed with wide variation across tracer conditions. SPs paid 76% less in public clinics, but proportions of correct management were similar to private clinics for three conditions and higher for the fourth. Kenyan outcomes compared favourably with India and China in all but the angina case. Conclusions The SP method is safe and effective in the urban Kenyan setting for the assessment of clinical practice. The pilot results suggest that public providers in this setting provide similar rates of correct management to private providers at significantly lower out-of-pocket costs for patients. However, comparisons across countries are sensitive to the tracer condition considered. PMID:29225937

From a Viewpoint of Clinical Settings: Pharmacoepidemiology as Reverse Translational Research (rTR).

PubMed

Kawakami, Junichi

2017-01-01

Clinical pharmacology and pharmacoepidemiology research may converge in practise. Pharmacoepidemiology is the study of pharmacotherapy and risk management in patient groups. For many drugs, adverse reaction(s) that were not seen and/or clarified during research and development stages have been reported in the real world. Pharmacoepidemiology can detect and verify adverse drug reactions as reverse translational research. Recently, development and effective use of medical information databases (MID) have been conducted in Japan and elsewhere for the purpose of post-marketing safety of drugs. The Ministry of Health, Labour and Welfare, Japan has been promoting the development of 10-million scale database in 10 hospitals and hospital groups as "the infrastructure project of medical information database (MID-NET)". This project enables estimation of the frequency of adverse reactions, the distinction between drug-induced reactions and basal health-condition changes, and usefulness verification of administrative measures of drug safety. However, because the database information is different from detailed medical records, construction of methodologies for the detection and evaluation of adverse reactions is required. We have been performing database research using medical information system in some hospitals to establish and demonstrate useful methods for post-marketing safety. In this symposium, we aim to discuss the possibility of reverse translational research from clinical settings and provide an introduction to our research.

Evaluation Metrics for Biostatistical and Epidemiological Collaborations

PubMed Central

Rubio, Doris McGartland; del Junco, Deborah J.; Bhore, Rafia; Lindsell, Christopher J.; Oster, Robert A.; Wittkowski, Knut M.; Welty, Leah J.; Li, Yi-Ju; DeMets, Dave

2011-01-01

Increasing demands for evidence-based medicine and for the translation of biomedical research into individual and public health benefit have been accompanied by the proliferation of special units that offer expertise in biostatistics, epidemiology, and research design (BERD) within academic health centers. Objective metrics that can be used to evaluate, track, and improve the performance of these BERD units are critical to their successful establishment and sustainable future. To develop a set of reliable but versatile metrics that can be adapted easily to different environments and evolving needs, we consulted with members of BERD units from the consortium of academic health centers funded by the Clinical and Translational Science Award Program of the National Institutes of Health. Through a systematic process of consensus building and document drafting, we formulated metrics that covered the three identified domains of BERD practices: the development and maintenance of collaborations with clinical and translational science investigators, the application of BERD-related methods to clinical and translational research, and the discovery of novel BERD-related methodologies. In this article, we describe the set of metrics and advocate their use for evaluating BERD practices. The routine application, comparison of findings across diverse BERD units, and ongoing refinement of the metrics will identify trends, facilitate meaningful changes, and ultimately enhance the contribution of BERD activities to biomedical research. PMID:21284015

A survey of cancer patient preferences: which types of snacks do they prefer during treatment?

PubMed

Danhauer, S C; Keim, J; Hurt, G; Vitolins, M

2009-01-01

Cancer patients undergoing treatment may find it difficult to maintain proper caloric intake. This survey sought to characterize food/beverage preferences and services related to nutritional needs for oncology outpatients. A total of 222 adult oncology patients completed surveys while in an oncology clinic for treatment or for a medical appointment. Data were collected on demographic characteristics, cancer diagnosis/treatment, general health behaviours, preferences for various foods and beverages that could feasibly be offered in the clinic setting and interest in nutrition-related services. Foods requested by at least 50% of the respondents included several types of crackers, doughnuts, fruit cups, cookies, applesauce and gelatin cups. Beverages requested by at least 50% of the respondents included filtered water, coffee, soft drinks and various juices. Nearly 50% requested caffeine-free beverages, and nearly 40% requested sugar-free food choices. Regarding nutrition-related services, respondents were most interested in recipes for persons with cancer, nutrition information/brochures and nutrition counselling. We found that assessing patients' nutritional preferences through survey methodology in the oncology clinic setting was feasible. It is important to aid patients' ability to consume food and beverages that they consider most palatable in order to maintain sufficient caloric intake during active treatment.

Guidelines for the Design and Conduct of Clinical Studies in Knee Articular Cartilage Repair

PubMed Central

Mithoefer, Kai; Saris, Daniel B.F.; Farr, Jack; Kon, Elizaveta; Zaslav, Kenneth; Cole, Brian J.; Ranstam, Jonas; Yao, Jian; Shive, Matthew; Levine, David; Dalemans, Wilfried; Brittberg, Mats

2011-01-01

Objective: To summarize current clinical research practice and develop methodological standards for objective scientific evaluation of knee cartilage repair procedures and products. Design: A comprehensive literature review was performed of high-level original studies providing information relevant for the design of clinical studies on articular cartilage repair in the knee. Analysis of cartilage repair publications and synopses of ongoing trials were used to identify important criteria for the design, reporting, and interpretation of studies in this field. Results: Current literature reflects the methodological limitations of the scientific evidence available for articular cartilage repair. However, clinical trial databases of ongoing trials document a trend suggesting improved study designs and clinical evaluation methodology. Based on the current scientific information and standards of clinical care, detailed methodological recommendations were developed for the statistical study design, patient recruitment, control group considerations, study endpoint definition, documentation of results, use of validated patient-reported outcome instruments, and inclusion and exclusion criteria for the design and conduct of scientifically sound cartilage repair study protocols. A consensus statement among the International Cartilage Repair Society (ICRS) and contributing authors experienced in clinical trial design and implementation was achieved. Conclusions: High-quality clinical research methodology is critical for the optimal evaluation of current and new cartilage repair technologies. In addition to generally applicable principles for orthopedic study design, specific criteria and considerations apply to cartilage repair studies. Systematic application of these criteria and considerations can facilitate study designs that are scientifically rigorous, ethical, practical, and appropriate for the question(s) being addressed in any given cartilage repair research project. PMID:26069574

Systematic Review of Knowledge Translation Strategies to Promote Research Uptake in Child Health Settings.

PubMed

Albrecht, Lauren; Archibald, Mandy; Snelgrove-Clarke, Erna; Scott, Shannon D

2016-01-01

Strategies to assist evidence-based decision-making for healthcare professionals are crucial to ensure high quality patient care and outcomes. The goal of this systematic review was to identify and synthesize the evidence on knowledge translation interventions aimed at putting explicit research evidence into child health practice. A comprehensive search of thirteen electronic databases was conducted, restricted by date (1985-2011) and language (English). Articles were included if: 1) studies were randomized controlled trials (RCT), controlled clinical trials (CCT), or controlled before-and-after (CBA) studies; 2) target population was child health professionals; 3) interventions implemented research in child health practice; and 4) outcomes were measured at the professional/process, patient, or economic level. Two reviewers independently extracted data and assessed methodological quality. Study data were aggregated and analyzed using evidence tables. Twenty-one studies (13 RCT, 2 CCT, 6 CBA) were included. The studies employed single (n=9) and multiple interventions (n=12). The methodological quality of the included studies was largely moderate (n=8) or weak (n=11). Of the studies with moderate to strong methodological quality ratings, three demonstrated consistent, positive effect(s) on the primary outcome(s); effective knowledge translation interventions were two single, non-educational interventions and one multiple, educational intervention. This multidisciplinary systematic review in child health setting identified effective knowledge translation strategies assessed by the most rigorous research designs. Given the overall poor quality of the research literature, specific recommendations were made to improve knowledge translation efforts in child health. Copyright © 2016 Elsevier Inc. All rights reserved.

Constructing a question bank based on script concordance approach as a novel assessment methodology in surgical education.

PubMed

Aldekhayel, Salah A; Alselaim, Nahar A; Magzoub, Mohi Eldin; Al-Qattan, Mohammad M; Al-Namlah, Abdullah M; Tamim, Hani; Al-Khayal, Abdullah; Al-Habdan, Sultan I; Zamakhshary, Mohammed F

2012-10-24

Script Concordance Test (SCT) is a new assessment tool that reliably assesses clinical reasoning skills. Previous descriptions of developing SCT-question banks were merely subjective. This study addresses two gaps in the literature: 1) conducting the first phase of a multistep validation process of SCT in Plastic Surgery, and 2) providing an objective methodology to construct a question bank based on SCT. After developing a test blueprint, 52 test items were written. Five validation questions were developed and a validation survey was established online. Seven reviewers were asked to answer this survey. They were recruited from two countries, Saudi Arabia and Canada, to improve the test's external validity. Their ratings were transformed into percentages. Analysis was performed to compare reviewers' ratings by looking at correlations, ranges, means, medians, and overall scores. Scores of reviewers' ratings were between 76% and 95% (mean 86% ± 5). We found poor correlations between reviewers (Pearson's: +0.38 to -0.22). Ratings of individual validation questions ranged between 0 and 4 (on a scale 1-5). Means and medians of these ranges were computed for each test item (mean: 0.8 to 2.4; median: 1 to 3). A subset of test items comprising 27 items was generated based on a set of inclusion and exclusion criteria. This study proposes an objective methodology for validation of SCT-question bank. Analysis of validation survey is done from all angles, i.e., reviewers, validation questions, and test items. Finally, a subset of test items is generated based on a set of criteria.

Clinical decision support systems for improving diagnostic accuracy and achieving precision medicine.

PubMed

Castaneda, Christian; Nalley, Kip; Mannion, Ciaran; Bhattacharyya, Pritish; Blake, Patrick; Pecora, Andrew; Goy, Andre; Suh, K Stephen

2015-01-01

As research laboratories and clinics collaborate to achieve precision medicine, both communities are required to understand mandated electronic health/medical record (EHR/EMR) initiatives that will be fully implemented in all clinics in the United States by 2015. Stakeholders will need to evaluate current record keeping practices and optimize and standardize methodologies to capture nearly all information in digital format. Collaborative efforts from academic and industry sectors are crucial to achieving higher efficacy in patient care while minimizing costs. Currently existing digitized data and information are present in multiple formats and are largely unstructured. In the absence of a universally accepted management system, departments and institutions continue to generate silos of information. As a result, invaluable and newly discovered knowledge is difficult to access. To accelerate biomedical research and reduce healthcare costs, clinical and bioinformatics systems must employ common data elements to create structured annotation forms enabling laboratories and clinics to capture sharable data in real time. Conversion of these datasets to knowable information should be a routine institutionalized process. New scientific knowledge and clinical discoveries can be shared via integrated knowledge environments defined by flexible data models and extensive use of standards, ontologies, vocabularies, and thesauri. In the clinical setting, aggregated knowledge must be displayed in user-friendly formats so that physicians, non-technical laboratory personnel, nurses, data/research coordinators, and end-users can enter data, access information, and understand the output. The effort to connect astronomical numbers of data points, including '-omics'-based molecular data, individual genome sequences, experimental data, patient clinical phenotypes, and follow-up data is a monumental task. Roadblocks to this vision of integration and interoperability include ethical, legal, and logistical concerns. Ensuring data security and protection of patient rights while simultaneously facilitating standardization is paramount to maintaining public support. The capabilities of supercomputing need to be applied strategically. A standardized, methodological implementation must be applied to developed artificial intelligence systems with the ability to integrate data and information into clinically relevant knowledge. Ultimately, the integration of bioinformatics and clinical data in a clinical decision support system promises precision medicine and cost effective and personalized patient care.

Level-Set Methodology on Adaptive Octree Grids

NASA Astrophysics Data System (ADS)

Gibou, Frederic; Guittet, Arthur; Mirzadeh, Mohammad; Theillard, Maxime

2017-11-01

Numerical simulations of interfacial problems in fluids require a methodology capable of tracking surfaces that can undergo changes in topology and capable to imposing jump boundary conditions in a sharp manner. In this talk, we will discuss recent advances in the level-set framework, in particular one that is based on adaptive grids.

A component modes projection and assembly model reduction methodology for articulated, multi-flexible body structures

NASA Technical Reports Server (NTRS)

Lee, Allan Y.; Tsuha, Walter S.

1993-01-01

A two-stage model reduction methodology, combining the classical Component Mode Synthesis (CMS) method and the newly developed Enhanced Projection and Assembly (EP&A) method, is proposed in this research. The first stage of this methodology, called the COmponent Modes Projection and Assembly model REduction (COMPARE) method, involves the generation of CMS mode sets, such as the MacNeal-Rubin mode sets. These mode sets are then used to reduce the order of each component model in the Rayleigh-Ritz sense. The resultant component models are then combined to generate reduced-order system models at various system configurations. A composite mode set which retains important system modes at all system configurations is then selected from these reduced-order system models. In the second stage, the EP&A model reduction method is employed to reduce further the order of the system model generated in the first stage. The effectiveness of the COMPARE methodology has been successfully demonstrated on a high-order, finite-element model of the cruise-configured Galileo spacecraft.

Exploring the bases for a mixed reality stroke rehabilitation system, Part I: A unified approach for representing action, quantitative evaluation, and interactive feedback

PubMed Central

2011-01-01

Background Although principles based in motor learning, rehabilitation, and human-computer interfaces can guide the design of effective interactive systems for rehabilitation, a unified approach that connects these key principles into an integrated design, and can form a methodology that can be generalized to interactive stroke rehabilitation, is presently unavailable. Results This paper integrates phenomenological approaches to interaction and embodied knowledge with rehabilitation practices and theories to achieve the basis for a methodology that can support effective adaptive, interactive rehabilitation. Our resulting methodology provides guidelines for the development of an action representation, quantification of action, and the design of interactive feedback. As Part I of a two-part series, this paper presents key principles of the unified approach. Part II then describes the application of this approach within the implementation of the Adaptive Mixed Reality Rehabilitation (AMRR) system for stroke rehabilitation. Conclusions The accompanying principles for composing novel mixed reality environments for stroke rehabilitation can advance the design and implementation of effective mixed reality systems for the clinical setting, and ultimately be adapted for home-based application. They furthermore can be applied to other rehabilitation needs beyond stroke. PMID:21875441

Comparative Effectiveness Research in Lung Diseases and Sleep Disorders

PubMed Central

Lieu, Tracy A.; Au, David; Krishnan, Jerry A.; Moss, Marc; Selker, Harry; Harabin, Andrea; Connors, Alfred

2011-01-01

The Division of Lung Diseases of the National Heart, Lung, and Blood Institute (NHLBI) held a workshop to develop recommendations on topics, methodologies, and resources for comparative effectiveness research (CER) that will guide clinical decision making about available treatment options for lung diseases and sleep disorders. A multidisciplinary group of experts with experience in efficacy, effectiveness, implementation, and economic research identified (a) what types of studies the domain of CER in lung diseases and sleep disorders should include, (b) the criteria and process for setting priorities, and (c) current resources for and barriers to CER in lung diseases. Key recommendations were to (1) increase efforts to engage stakeholders in developing CER questions and study designs; (2) invest in further development of databases and other infrastructure, including efficient methods for data sharing; (3) make full use of a broad range of study designs; (4) increase the appropriate use of observational designs and the support of methodologic research; (5) ensure that committees that review CER grant applications include persons with appropriate perspective and expertise; and (6) further develop the workforce for CER by supporting training opportunities that focus on the methodologic and practical skills needed. PMID:21965016

Next Generation Sequencing Technology and Genomewide Data Analysis: Perspectives for Retinal Research

PubMed Central

Chaitankar, Vijender; Karakülah, Gökhan; Ratnapriya, Rinki; Giuste, Felipe O.; Brooks, Matthew J.; Swaroop, Anand

2016-01-01

The advent of high throughput next generation sequencing (NGS) has accelerated the pace of discovery of disease-associated genetic variants and genomewide profiling of expressed sequences and epigenetic marks, thereby permitting systems-based analyses of ocular development and disease. Rapid evolution of NGS and associated methodologies presents significant challenges in acquisition, management, and analysis of large data sets and for extracting biologically or clinically relevant information. Here we illustrate the basic design of commonly used NGS-based methods, specifically whole exome sequencing, transcriptome, and epigenome profiling, and provide recommendations for data analyses. We briefly discuss systems biology approaches for integrating multiple data sets to elucidate gene regulatory or disease networks. While we provide examples from the retina, the NGS guidelines reviewed here are applicable to other tissues/cell types as well. PMID:27297499

Characterization of Covalent-Reversible EGFR Inhibitors

PubMed Central

2017-01-01

Within the spectrum of kinase inhibitors, covalent-reversible inhibitors (CRIs) provide a valuable alternative approach to classical covalent inhibitors. This special class of inhibitors can be optimized for an extended drug-target residence time. For CRIs, it was shown that the fast addition of thiols to electron-deficient olefins leads to a covalent bond that can break reversibly under proteolytic conditions. Research groups are just beginning to include CRIs in their arsenal of compound classes, and, with that, the understanding of this interesting set of chemical warheads is growing. However, systems to assess both characteristics of the covalent-reversible bond in a simple experimental setting are sparse. Here, we have developed an efficient methodology to characterize the covalent and reversible properties of CRIs and to investigate their potential in targeting clinically relevant variants of the receptor tyrosine kinase EGFR.

The management of ectodermal dysplasia and severe hypodontia. International conference statements.

PubMed

Hobkirk, J A; Nohl, F; Bergendal, B; Storhaug, K; Richter, M K

2006-09-01

An international conference on ectodermal dysplasias and hypodontia, held in London in 2004, featured a session devoted to the management of the ectodermal dysplasias and severe hypodontia. This paper presents a set of statements prepared by an international specialist panel, including representatives of patient support groups, who presented and subsequently debated a series of papers on this subject. The following topics were explored: potential roles of patient support groups; core care standards, including the roles and composition of medical and dental multidisciplinary teams for treating these conditions; the format of a baseline data set for patients with an ED; and priorities for research in ectodermal dysplasias, with particular regard to laboratory and clinical studies, and research methodology. The statements are intended to form an international framework for developing patient care pathways, and collaborative research in this field.

Reply to "Further issues in determining the readability of self-report items: comment on McHugh and Behar (2009)".

PubMed

McHugh, R Kathryn; Behar, Evelyn

2012-12-01

In his commentary on our previously published article "Readability of Self-Report Measures of Depression and Anxiety," J. Schinka (2012) argued for the importance of considering readability of patient materials and highlighted limitations of existing methodologies for this assessment. Schinka's commentary articulately described the weaknesses of readability assessment and emphasized the importance of the development of improved strategies for assessing readability to maximize the validity of self-report measures in applied settings. In our reply, we support and extend Schinka's argument, highlighting the importance of consideration of the range of factors (e.g., use of reverse-scored items) that may increase respondent difficulty with comprehension. Consideration of the readability of self-report symptom measures is critical to the validity of these measures in both clinical practice and research settings.

Nurse manager and student nurse perceptions of the use of personal smartphones or tablets and the adjunct applications, as an educational tool in clinical settings.

PubMed

McNally, George; Frey, Rosemary; Crossan, Michael

2017-03-01

Personally owned handheld referencing technology such as smartphones or tablets, and the adjunct applications (apps) that can be used on them, are becoming a part of everyday life for the New Zealand population. In common with the population at large, student nurses have embraced this technology since the advent of the Apple iPhone in 2010. Little is known internationally or in New Zealand about the way student nurses may apply personally owned handheld referencing technology to their education process. The perceptions of New Zealand nurse managers, toward personally owned handheld referencing technology, could not be located. Using a qualitative descriptive methodology, semi structured interviews were conducted with New Zealand student nurses (n = 13), and nurse managers (n = 5) about their perceptions of use of personally owned handheld referencing technology as an educational tool in clinical settings. A thematic analysis was conducted on the resulting text. Student nurses said they wanted to use their own handheld referencing technology to support clinical decisions. Nurse managers perceived the use of personally owned handheld referencing technology as unprofessional, and do not trust younger cohorts of student nurses to act ethically when using this technology. This research supports historical research findings from the student perspective about the usefulness of older hand held referencing devices to augment clinical decisions. However, due to perceptions held by nurse mangers regarding professional behaviour, safety and the perceived institutional costs of managing personally owned handheld referencing technology, the practice may remain problematic in the studied setting. Copyright © 2017 Elsevier Ltd. All rights reserved.

Rural Doctors' Views on and Experiences with Evidence-Based Medicine: The FrEEDoM Qualitative Study.

PubMed

Hisham, Ranita; Liew, Su May; Ng, Chirk Jenn; Mohd Nor, Kamaliah; Osman, Iskandar Firzada; Ho, Gah Juan; Hamzah, Nurazira; Glasziou, Paul

2016-01-01

Evidence-based medicine is the integration of individual clinical expertise, best external evidence and patient values which was introduced more than two decades ago. Yet, primary care physicians in Malaysia face unique barriers in accessing scientific literature and applying it to their clinical practice. This study aimed to explore the views and experiences of rural doctors' about evidence-based medicine in their daily clinical practice in a rural primary care setting. Qualitative methodology was used. The interviews were conducted in June 2013 in two rural health clinics in Malaysia. The participants were recruited using purposive sampling. Four focus group discussions with 15 medical officers and three individual in-depth interviews with family medicine specialists were carried out. All interviews were conducted using a topic guide and were audio-recorded, transcribed verbatim, checked and analyzed using a thematic approach. Key themes identified were: (1) doctors viewed evidence-based medicine mainly as statistics, research and guidelines, (2) reactions to evidence-based medicine were largely negative, (3) doctors relied on specialists, peers, guidelines and non-evidence based internet sources for information, (4) information sources were accessed using novel methods such as mobile applications and (5) there are several barriers to evidence-based practice, including doctor-, evidence-based medicine-, patient- and system-related factors. These included inadequacies in knowledge, attitude, management support, time and access to evidence-based information sources. Participants recommended the use of online services to support evidence-based practice in the rural settings. The level of evidence-based practice is low in the rural setting due to poor awareness, knowledge, attitude and resources. Doctors use non-evidence based sources and access them through new methods such as messaging applications. Further research is recommended to develop and evaluate interventions to overcome the identified barriers.

Developing accreditation for community based surgery: the Irish experience.

PubMed

Ní Riain, Ailís; Collins, Claire; O'Sullivan, Tony

2018-02-05

Purpose Carrying out minor surgery procedures in the primary care setting is popular with patients, cost effective and delivers at least as good outcomes as those performed in the hospital setting. This paper aims to describe the central role of clinical leadership in developing an accreditation system for general practitioners (GPs) undertaking community-based surgery in the Irish national setting where no mandatory accreditation process currently exists. Design/methodology/approach In all, 24 GPs were recruited to the GP network. Ten pilot standards were developed addressing GPs' experience and training, clinical activity and practice supporting infrastructure and tested, using information and document review, prospective collection of clinical data and a practice inspection visit. Two additional components were incorporated into the project (patient satisfaction survey and self-audit). A multi-modal evaluation was undertaken. A majority of GPs was included at all stages of the project, in line with the principles of action learning. The steering group had a majority of GPs with relevant expertise and representation of all other actors in the minor surgery arena. The GP research network contributed to each stage of the project. The project lead was a GP with minor surgery experience. Quantitative data collected were analysed using Predictive Analytic SoftWare. Krueger's framework analysis approach was used to analyse the qualitative data. Findings A total of 9 GPs achieved all standards at initial review, 14 successfully completed corrective actions and 1 GP did not achieve the required standard. Standards were then amended to reflect findings and a supporting framework was developed. Originality/value The flexibility of the action-learning approach and the clinical leadership design allowed for the development of robust quality standards in a short timeframe.

IMSF: Infinite Methodology Set Framework

NASA Astrophysics Data System (ADS)

Ota, Martin; Jelínek, Ivan

Software development is usually an integration task in enterprise environment - few software applications work autonomously now. It is usually a collaboration of heterogeneous and unstable teams. One serious problem is lack of resources, a popular result being outsourcing, ‘body shopping’, and indirectly team and team member fluctuation. Outsourced sub-deliveries easily become black boxes with no clear development method used, which has a negative impact on supportability. Such environments then often face the problems of quality assurance and enterprise know-how management. The used methodology is one of the key factors. Each methodology was created as a generalization of a number of solved projects, and each methodology is thus more or less connected with a set of task types. When the task type is not suitable, it causes problems that usually result in an undocumented ad-hoc solution. This was the motivation behind formalizing a simple process for collaborative software engineering. Infinite Methodology Set Framework (IMSF) defines the ICT business process of adaptive use of methods for classified types of tasks. The article introduces IMSF and briefly comments its meta-model.

Methodology for extracting local constants from petroleum cracking flows

DOEpatents

Chang, Shen-Lin; Lottes, Steven A.; Zhou, Chenn Q.

2000-01-01

A methodology provides for the extraction of local chemical kinetic model constants for use in a reacting flow computational fluid dynamics (CFD) computer code with chemical kinetic computations to optimize the operating conditions or design of the system, including retrofit design improvements to existing systems. The coupled CFD and kinetic computer code are used in combination with data obtained from a matrix of experimental tests to extract the kinetic constants. Local fluid dynamic effects are implicitly included in the extracted local kinetic constants for each particular application system to which the methodology is applied. The extracted local kinetic model constants work well over a fairly broad range of operating conditions for specific and complex reaction sets in specific and complex reactor systems. While disclosed in terms of use in a Fluid Catalytic Cracking (FCC) riser, the inventive methodology has application in virtually any reaction set to extract constants for any particular application and reaction set formulation. The methodology includes the step of: (1) selecting the test data sets for various conditions; (2) establishing the general trend of the parametric effect on the measured product yields; (3) calculating product yields for the selected test conditions using coupled computational fluid dynamics and chemical kinetics; (4) adjusting the local kinetic constants to match calculated product yields with experimental data; and (5) validating the determined set of local kinetic constants by comparing the calculated results with experimental data from additional test runs at different operating conditions.

A Hierarchical Clustering Methodology for the Estimation of Toxicity

EPA Science Inventory

A Quantitative Structure Activity Relationship (QSAR) methodology based on hierarchical clustering was developed to predict toxicological endpoints. This methodology utilizes Ward's method to divide a training set into a series of structurally similar clusters. The structural sim...

[Clinical practice guidelines in Peru: evaluation of its quality using the AGREE II instrument].

PubMed

Canelo-Aybar, Carlos; Balbin, Graciela; Perez-Gomez, Ángela; Florez, Iván D

2016-01-01

To evaluate the methodological quality of clinical practice guidelines (CPGs) put into practice by the Peruvian Ministry of Health (MINSA), 17 CPGs from the ministry, published between 2009 and 2014, were independently evaluated by three methodologic experts using the AGREE II instrument. The score of AGREE II domains was low and very low in all CPGs: scope and purpose (medium, 44%), clarity of presentation (medium, 47%), participation of decision-makers (medium, 8%), methodological rigor (medium, 5%), applicability (medium, 5%), and editorial independence (medium, 8%). In conclusion, the methodological quality of CPGs implemented by the MINSA is low. Consequently, its use could not be recommended. The implementation of the methodology for the development of CPGs described in the recentlypublished CPG methodological preparation manual in Peru is a pressing need.

Development and Preliminary Evaluation of a Multivariate Index Assay for Ovarian Cancer

PubMed Central

Chen, Tzong-Hao; Bergstrom, Katharine J.; Zhao, Jinghua; Seshaiah, Partha; Yip, Ping; Mansfield, Brian C.

2009-01-01

Background Most women with a clinical presentation consistent with ovarian cancer have benign conditions. Therefore methods to distinguish women with ovarian cancer from those with benign conditions would be beneficial. We describe the development and preliminary evaluation of a serum-based multivariate assay for ovarian cancer. This hypothesis-driven study examined whether an informative pattern could be detected in stage I disease that persists through later stages. Methodology/Principal Findings Sera, collected under uniform protocols from multiple institutions, representing 176 cases and 187 controls from women presenting for surgery were examined using high-throughput, multiplexed immunoassays. All stages and common subtypes of epithelial ovarian cancer, and the most common benign ovarian conditions were represented. A panel of 104 antigens, 44 autoimmune and 56 infectious disease markers were assayed and informative combinations identified. Using a training set of 91 stage I data sets, representing 61 individual samples, and an equivalent number of controls, an 11-analyte profile, composed of CA-125, CA 19-9, EGF-R, C-reactive protein, myoglobin, apolipoprotein A1, apolipoprotein CIII, MIP-1α, IL-6, IL-18 and tenascin C was identified and appears informative for all stages and common subtypes of ovarian cancer. Using a testing set of 245 samples, approximately twice the size of the model building set, the classifier had 91.3% sensitivity and 88.5% specificity. While these preliminary results are promising, further refinement and extensive validation of the classifier in a clinical trial is necessary to determine if the test has clinical value. Conclusions/Significance We describe a blood-based assay using 11 analytes that can distinguish women with ovarian cancer from those with benign conditions. Preliminary evaluation of the classifier suggests it has the potential to offer approximately 90% sensitivity and 90% specificity. While promising, the performance needs to be assessed in a blinded clinical validation study. PMID:19240799

Using discrete choice experiments within a cost-benefit analysis framework: some considerations.

PubMed

McIntosh, Emma

2006-01-01

A great advantage of the stated preference discrete choice experiment (SPDCE) approach to economic evaluation methodology is its immense flexibility within applied cost-benefit analyses (CBAs). However, while the use of SPDCEs in healthcare has increased markedly in recent years there has been a distinct lack of equivalent CBAs in healthcare using such SPDCE-derived valuations. This article outlines specific issues and some practical suggestions for consideration relevant to the development of CBAs using SPDCE-derived benefits. The article shows that SPDCE-derived CBA can adopt recent developments in cost-effectiveness methodology including the cost-effectiveness plane, appropriate consideration of uncertainty, the net-benefit framework and probabilistic sensitivity analysis methods, while maintaining the theoretical advantage of the SPDCE approach. The concept of a cost-benefit plane is no different in principle to the cost-effectiveness plane and can be a useful tool for reporting and presenting the results of CBAs.However, there are many challenging issues to address for the advancement of CBA methodology using SPCDEs within healthcare. Particular areas for development include the importance of accounting for uncertainty in SPDCE-derived willingness-to-pay values, the methodology of SPDCEs in clinical trial settings and economic models, measurement issues pertinent to using SPDCEs specifically in healthcare, and the importance of issues such as consideration of the dynamic nature of healthcare and the resulting impact this has on the validity of attribute definitions and context.

Quality assurance and quality control in mammography: a review of available guidance worldwide.

PubMed

Reis, Cláudia; Pascoal, Ana; Sakellaris, Taxiarchis; Koutalonis, Manthos

2013-10-01

Review available guidance for quality assurance (QA) in mammography and discuss its contribution to harmonise practices worldwide. Literature search was performed on different sources to identify guidance documents for QA in mammography available worldwide in international bodies, healthcare providers, professional/scientific associations. The guidance documents identified were reviewed and a selection was compared for type of guidance (clinical/technical), technology and proposed QA methodologies focusing on dose and image quality (IQ) performance assessment. Fourteen protocols (targeted at conventional and digital mammography) were reviewed. All included recommendations for testing acquisition, processing and display systems associated with mammographic equipment. All guidance reviewed highlighted the importance of dose assessment and testing the Automatic Exposure Control (AEC) system. Recommended tests for assessment of IQ showed variations in the proposed methodologies. Recommended testing focused on assessment of low-contrast detection, spatial resolution and noise. QC of image display is recommended following the American Association of Physicists in Medicine guidelines. The existing QA guidance for mammography is derived from key documents (American College of Radiology and European Union guidelines) and proposes similar tests despite the variations in detail and methodologies. Studies reported on QA data should provide detail on experimental technique to allow robust data comparison. Countries aiming to implement a mammography/QA program may select/prioritise the tests depending on available technology and resources. •An effective QA program should be practical to implement in a clinical setting. •QA should address the various stages of the imaging chain: acquisition, processing and display. •AEC system QC testing is simple to implement and provides information on equipment performance.

National audit of the sensitivity of double-contrast barium enema for colorectal carcinoma, using control charts For the Royal College of Radiologists Clinical Radiology Audit Sub-Committee.

PubMed

Tawn, D J; Squire, C J; Mohammed, M A; Adam, E J

2005-05-01

To audit the sensitivity of double-contrast barium enema (DCBE) for colorectal carcinoma, as currently practised in UK departments of radiology. As part of its programme of national audits, the Royal College of Radiologists Clinical Radiology Audit Sub-Committee undertook a retrospective audit of the sensitivity of DCBE for colorectal carcinoma during 2002. The following targets were set: demonstration of a lesion > or =95%; correct identification as a carcinoma > or =90%. Across the UK, 131 departments took part in the audit, involving 5454 examinations. The mean demonstration rate was 92.9% and the diagnosis rate was 85.9%, slightly below the targets set. The equivocal rate (lesion demonstrated, but not defined as malignant) was 6.9%, the perception failure rate was 2.8% and the technical failure rate was 4.4%. Control-chart methodology was used to analyze the data and to identify any departments whose performance was consistent with special-cause variation. When compared with the diagnosis rate (84.6%) and demonstration rate (92.7%) reported in the Wessex Audit 1995, [Thomas RD, Fairhurst JJ, Frost RA. Wessex regional audit: barium enema in colo-rectal carcinoma. Clin Radiol 1995;50:647-50.] a similar level of performance was observed in the NHS today, implying that the basic process for undertaking and reporting DCBE has remained relatively unchanged over the last few years. Improvement in the future will require fundamental changes to the process of reporting DCBE, in order to minimize the perception failure rate and accurately to describe lesions, so reducing the equivocal rate. Control-chart methodology has a useful role in identifying strategies to deliver continual improvement.

A Machine Learning Approach to Identifying Placebo Responders in Late-Life Depression Trials.

PubMed

Zilcha-Mano, Sigal; Roose, Steven P; Brown, Patrick J; Rutherford, Bret R

2018-01-11

Despite efforts to identify characteristics associated with medication-placebo differences in antidepressant trials, few consistent findings have emerged to guide participant selection in drug development settings and differential therapeutics in clinical practice. Limitations in the methodologies used, particularly searching for a single moderator while treating all other variables as noise, may partially explain the failure to generate consistent results. The present study tested whether interactions between pretreatment patient characteristics, rather than a single-variable solution, may better predict who is most likely to benefit from placebo versus medication. Data were analyzed from 174 patients aged 75 years and older with unipolar depression who were randomly assigned to citalopram or placebo. Model-based recursive partitioning analysis was conducted to identify the most robust significant moderators of placebo versus citalopram response. The greatest signal detection between medication and placebo in favor of medication was among patients with fewer years of education (≤12) who suffered from a longer duration of depression since their first episode (>3.47 years) (B = 2.53, t(32) = 3.01, p = 0.004). Compared with medication, placebo had the greatest response for those who were more educated (>12 years), to the point where placebo almost outperformed medication (B = -0.57, t(96) = -1.90, p = 0.06). Machine learning approaches capable of evaluating the contributions of multiple predictor variables may be a promising methodology for identifying placebo versus medication responders. Duration of depression and education should be considered in the efforts to modulate placebo magnitude in drug development settings and in clinical practice. Copyright © 2018 American Association for Geriatric Psychiatry. Published by Elsevier Inc. All rights reserved.

Lessons learned from IDeAl - 33 recommendations from the IDeAl-net about design and analysis of small population clinical trials.

PubMed

Hilgers, Ralf-Dieter; Bogdan, Malgorzata; Burman, Carl-Fredrik; Dette, Holger; Karlsson, Mats; König, Franz; Male, Christoph; Mentré, France; Molenberghs, Geert; Senn, Stephen

2018-05-11

IDeAl (Integrated designs and analysis of small population clinical trials) is an EU funded project developing new statistical design and analysis methodologies for clinical trials in small population groups. Here we provide an overview of IDeAl findings and give recommendations to applied researchers. The description of the findings is broken down by the nine scientific IDeAl work packages and summarizes results from the project's more than 60 publications to date in peer reviewed journals. In addition, we applied text mining to evaluate the publications and the IDeAl work packages' output in relation to the design and analysis terms derived from in the IRDiRC task force report on small population clinical trials. The results are summarized, describing the developments from an applied viewpoint. The main result presented here are 33 practical recommendations drawn from the work, giving researchers a comprehensive guidance to the improved methodology. In particular, the findings will help design and analyse efficient clinical trials in rare diseases with limited number of patients available. We developed a network representation relating the hot topics developed by the IRDiRC task force on small population clinical trials to IDeAl's work as well as relating important methodologies by IDeAl's definition necessary to consider in design and analysis of small-population clinical trials. These network representation establish a new perspective on design and analysis of small-population clinical trials. IDeAl has provided a huge number of options to refine the statistical methodology for small-population clinical trials from various perspectives. A total of 33 recommendations developed and related to the work packages help the researcher to design small population clinical trial. The route to improvements is displayed in IDeAl-network representing important statistical methodological skills necessary to design and analysis of small-population clinical trials. The methods are ready for use.

Introduction to SIMRAND: Simulation of research and development project

NASA Technical Reports Server (NTRS)

Miles, R. F., Jr.

1982-01-01

SIMRAND: SIMulation of Research ANd Development Projects is a methodology developed to aid the engineering and management decision process in the selection of the optimal set of systems or tasks to be funded on a research and development project. A project may have a set of systems or tasks under consideration for which the total cost exceeds the allocated budget. Other factors such as personnel and facilities may also enter as constraints. Thus the project's management must select, from among the complete set of systems or tasks under consideration, a partial set that satisfies all project constraints. The SIMRAND methodology uses analytical techniques and probability theory, decision analysis of management science, and computer simulation, in the selection of this optimal partial set. The SIMRAND methodology is truly a management tool. It initially specifies the information that must be generated by the engineers, thus providing information for the management direction of the engineers, and it ranks the alternatives according to the preferences of the decision makers.

[How to evaluate the application of Clinical Governance tools in the management of hospitalized hyperglycemic patients: results of a multicentric study].

PubMed

De Belvis, Antonio Giulio; Specchia, Maria Lucia; Ferriero, Anna Maria; Capizzi, Silvio

2017-01-01

Risk management is a key tool in Clinical Governance. Our project aimed to define, share, apply and measure the impact of tools and methodologies for the continuous improvement of quality of care, especially in relation to the multi-disciplinary and integrated management of the hyperglycemic patient in hospital settings. A training project, coordinated by a scientific board of experts in diabetes and health management and an Expert Meeting with representatives of all the participating centers was launched in 2014. The project involved eight hospitals through the organization of meetings with five managers and 25 speakers, including diabetologists, internists, pharmacists and nurses. The analysis showed a wide variability in the adoption of tools and processes towards a comprehensive and coordinated management of hyperglycemic patients.

EU decision-making for marketing authorization of advanced therapy medicinal products: a case study.

PubMed

de Wilde, Sofieke; Coppens, Delphi G M; Hoekman, Jarno; de Bruin, Marie L; Leufkens, Hubert G M; Guchelaar, Henk-Jan; Meij, Pauline

2018-03-21

A comparative analysis of assessment procedures for authorization of all European Union (EU) applications for advanced therapy medicinal products (ATMPs) shows that negative opinions were associated with a lack of clinical efficacy and identified severe safety risks. Unmet medical need was often considered in positive opinions and outweighed scientific uncertainties. Numerous quality issues illustrate the difficulties in this domain for ATMP development. Altogether, it suggests that setting appropriate standards for ATMP authorization in Europe, similar to elsewhere, is a learning experience. The experimental characteristics of authorized ATMPs urge regulators, industry, and clinical practice to pay accurate attention to post-marketing risk management to limit patient risk. Methodologies for ATMP development and regulatory evaluations need to be continuously evaluated for the field to flourish. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

Antifungal susceptibility and pathogenic potential of environmental isolated filamentous fungi compared with colonizing agents in immunocompromised patients.

PubMed

Teixeira, A B A; Silva, M; Lyra, L; Luz, E A; Uno, J; Takada, H; Miyaji, M; Nishimura, K; Schreiber, A Z

2005-09-01

Infection is a major cause of morbidity and mortality in bone marrow transplant recipients and in patients with hematological malignancies. The source of infection is almost always endogenous flora or the hospital environment. The present study evaluated bone marrow transplant recipients and patients with hematological malignancies colonized and/or infected with filamentous fungi. During 1 year, environmental air samples were also taken from the bone marrow transplant unit by a modification of gravity air-setting plate (GASP) methodology. Fusarium spp. were the most prevalent genus in the fall and Cladosporium spp. in the winter. Clinically isolated strains grew better at 37 degrees C than environmental strains. According to NCCLS M-38P methods, environmental Aspergillus strains showed higher MICs to miconazol and itraconazol, and clinical Fusarium strains were less susceptible to fluconazole.

Applications of Data Mining Methods in the Integrative Medical Studies of Coronary Heart Disease: Progress and Prospect

PubMed Central

Wang, Yixin; Guo, Fang

2014-01-01

A large amount of studies show that real-world study has strong external validity than the traditional randomized controlled trials and can evaluate the effect of interventions in a real clinical setting, which open up a new path for researches of integrative medicine in coronary heart disease. However, clinical data of integrative medicine in coronary heart disease are large in amount and complex in data types, making exploring the appropriate methodology a hot topic. Data mining techniques are to analyze and dig out useful information and knowledge from the mass data to guide people's practices. The present review provides insights for the main features of data mining and their applications of integrative medical studies in coronary heart disease, aiming to analyze the progress and prospect in this field. PMID:25544853

Clinician user involvement in the real world: Designing an electronic tool to improve interprofessional communication and collaboration in a hospital setting.

PubMed

Tang, Terence; Lim, Morgan E; Mansfield, Elizabeth; McLachlan, Alexander; Quan, Sherman D

2018-02-01

User involvement is vital to the success of health information technology implementation. However, involving clinician users effectively and meaningfully in complex healthcare organizations remains challenging. The objective of this paper is to share our real-world experience of applying a variety of user involvement methods in the design and implementation of a clinical communication and collaboration platform aimed at facilitating care of complex hospitalized patients by an interprofessional team of clinicians. We designed and implemented an electronic clinical communication and collaboration platform in a large community teaching hospital. The design team consisted of both technical and healthcare professionals. Agile software development methodology was used to facilitate rapid iterative design and user input. We involved clinician users at all stages of the development lifecycle using a variety of user-centered, user co-design, and participatory design methods. Thirty-six software releases were delivered over 24 months. User involvement has resulted in improvement in user interface design, identification of software defects, creation of new modules that facilitated workflow, and identification of necessary changes to the scope of the project early on. A variety of user involvement methods were complementary and benefited the design and implementation of a complex health IT solution. Combining these methods with agile software development methodology can turn designs into functioning clinical system to support iterative improvement. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

Aiming for a holistic integrated service for men diagnosed with prostate cancer - Definitions of standards and skill sets for nurses and allied healthcare professionals.

PubMed

Lamb, Alastair D; Thompson, Sue; Kinsella, Netty; Gerbitz, Ingmar; Chapman, Elaine; Putt, Lisa; Bennett, Sophie; Thankappannair, Vineetha; Geoghegan, Lisa; Wright, Naomi; Stirton-Croft, Alison; Nixon, Penny; Styling, Andrew; Whitney, Diane; Hodgson, Lindsay; Punt, Lisa; Longmore, Jenny; Carter, Mike; Petch, Bill; Rimmer, Yvonne; Russell, Simon; Hughes-Davies, Luke; Mazhar, Danish; Shah, Nimish C; Gnanapragasam, Vincent J; Doble, Andrew; Bratt, Ola; Kastner, Christof

2017-08-01

To establish a comprehensive set of recommendations for the service structure and skill set of nurses and allied healthcare professionals in prostate cancer care. Using components of formal consensus methodology, a 30-member multidisciplinary panel produced 53 items for discussion relating to the provision of care for prostate cancer patients by specialist nurses and allied healthcare professionals. Items were developed by two rounds of email correspondence in which, first, items were generated and, second, items refined to form the basis of a consensus meeting which constituted the third round of review. The fourth and final round was an email review of the consensus output. The panel agreed on 33 items that were appropriate for recommendations to be made. These items were grouped under categories of "Environment" and "Patient Pathway" and included comments on training, leadership, communication and quality assessment as well as specific items related to prostate diagnosis clinics, radical treatment clinics and follow-up survivor groups. Specialist nurses and allied healthcare professionals play a vital role alongside urologists and oncologists to provide care to men with prostate cancer and their families. We present a set of standards and consensus recommendations for the roles and skill-set required for these practitioners to provide gold-standard prostate cancer care. These recommendations could form the basis for development of comprehensive integrated prostate cancer pathways in prostate cancer centres as well as providing guidance for any units treating men with prostate cancer. Copyright © 2017. Published by Elsevier Ltd.

Systematic reviews of animal studies; missing link in translational research?

PubMed

van Luijk, Judith; Bakker, Brenda; Rovers, Maroeska M; Ritskes-Hoitinga, Merel; de Vries, Rob B M; Leenaars, Marlies

2014-01-01

The methodological quality of animal studies is an important factor hampering the translation of results from animal studies to a clinical setting. Systematic reviews of animal studies may provide a suitable method to assess and thereby improve their methodological quality. The aims of this study were: 1) to evaluate the risk of bias assessment in animal-based systematic reviews, and 2) to study the internal validity of the primary animal studies included in these systematic reviews. We systematically searched Pubmed and Embase for SRs of preclinical animal studies published between 2005 and 2012. A total of 91 systematic reviews met our inclusion criteria. The risk of bias was assessed in 48 (52.7%) of these 91 systematic reviews. Thirty-three (36.3%) SRs provided sufficient information to evaluate the internal validity of the included studies. Of the evaluated primary studies, 24.6% was randomized, 14.6% reported blinding of the investigator/caretaker, 23.9% blinded the outcome assessment, and 23.1% reported drop-outs. To improve the translation of animal data to clinical practice, systematic reviews of animal studies are worthwhile, but the internal validity of primary animal studies needs to be improved. Furthermore, risk of bias should be assessed by systematic reviews of animal studies to provide insight into the reliability of the available evidence.

Breakpoints for antifungal agents: an update from EUCAST focussing on echinocandins against Candida spp. and triazoles against Aspergillus spp.

PubMed

Arendrup, Maiken C; Cuenca-Estrella, Manuel; Lass-Flörl, Cornelia; Hope, William W

2013-12-01

Candida and Aspergillus infections have emerged as significant pathogens in recent decades. During this same time, broad spectrum triazole and echinocandin antifungal agents have been developed and increasingly used. One consequence of widespread use is leading to the emergence of mutants with acquired resistance mutations. Therefore, accurate susceptibility testing and appropriate clinical breakpoints for the interpretation of susceptibility results have become increasingly important. Here we review the underlying methodology by which breakpoints have been selected by EUCAST (European Committee on Antimicrobial Susceptibility Testing). Five parameters are evaluated: dosing regimens used; EUCAST MIC distributions from multiple laboratories, species and compound specific epidemiological cut off values (upper MIC limits of wild type isolates or ECOFFs), pharmacokinetic/pharmacodynamic relationships and targets associated with outcome and finally clinical data by species and MIC when available. The general principles are reviewed followed by a detailed review of the individual aspects for Candida species and the three echinocandins and for Aspergillus and the three mould-active azoles. This review provides an update of the subcommittee on antifungal susceptibility testing (AFST) of the EUCAST methodology and summarises the current EUCAST breakpoints for Candida and Aspergillus. Recommendations about applicability of antifungal susceptibility testing in the routine setting are also included. Copyright © 2014 Elsevier Ltd. All rights reserved.

How the Role of Socialization Affects Blended Learning Methodologies for Faculty Working with Teams in a Healthcare Setting

ERIC Educational Resources Information Center

Kenny, Kevin J.

2010-01-01

When looking at healthcare education settings, one barrier to understanding the nature of socialization and its effect on teaching methodology design is the advent of blended learning formats used within education departments. The author utilized qualitative research using grounded theory with deductive, verification and inductive processes to…

Research on Natural Settings: Observing Adolescent Mothers and Infants throughout the First Postpartum Year.

PubMed

Diniz, Eva; Koller, Silvia H

2018-03-01

This manuscript aims to present and discuss challenges regarding naturalistic observation of adolescent mothers and their infants throughout the first postpartum year. Case illustrations were the object to discuss methodological options and issues faced during an observational and longitudinal research. The participants live in vulnerability in a metropolitan area in Southern Brazil. Data collection challenges led to reflections about naturalistic observation and methodological procedures, which were affected by setting characteristics and by the need of adapting to them. Most methodological difficulties were linked to naturalistic observations of mothers and their infants. Personal and contextual aspects of these settings must be taken into account in order to enhance result reliability and the knowledge about cultural idiosyncrasies.

A Bayesian approach to truncated data sets: An application to Malmquist bias in Supernova Cosmology

NASA Astrophysics Data System (ADS)

March, Marisa Cristina

2018-01-01

A problem commonly encountered in statistical analysis of data is that of truncated data sets. A truncated data set is one in which a number of data points are completely missing from a sample, this is in contrast to a censored sample in which partial information is missing from some data points. In astrophysics this problem is commonly seen in a magnitude limited survey such that the survey is incomplete at fainter magnitudes, that is, certain faint objects are simply not observed. The effect of this `missing data' is manifested as Malmquist bias and can result in biases in parameter inference if it is not accounted for. In Frequentist methodologies the Malmquist bias is often corrected for by analysing many simulations and computing the appropriate correction factors. One problem with this methodology is that the corrections are model dependent. In this poster we derive a Bayesian methodology for accounting for truncated data sets in problems of parameter inference and model selection. We first show the methodology for a simple Gaussian linear model and then go on to show the method for accounting for a truncated data set in the case for cosmological parameter inference with a magnitude limited supernova Ia survey.

Establishment of Requirements and Methodology for the Development and Implementation of GreyMatters, a Memory Clinic Information System.

PubMed

Tapuria, Archana; Evans, Matt; Curcin, Vasa; Austin, Tony; Lea, Nathan; Kalra, Dipak

2017-01-01

The aim of the paper is to establish the requirements and methodology for the development process of GreyMatters, a memory clinic system, outlining the conceptual, practical, technical and ethical challenges, and the experiences of capturing clinical and research oriented data along with the implementation of the system. The methodology for development of the information system involved phases of requirements gathering, modeling and prototype creation, and 'bench testing' the prototype with experts. The standard Institute of Electrical and Electronics Engineers (IEEE) recommended approach for the specifications of software requirements was adopted. An electronic health record (EHR) standard, EN13606 was used, and clinical modelling was done through archetypes and the project complied with data protection and privacy legislation. The requirements for GreyMatters were established. Though the initial development was complex, the requirements, methodology and standards adopted made the construction, deployment, adoption and population of a memory clinic and research database feasible. The electronic patient data including the assessment scales provides a rich source of objective data for audits and research and to establish study feasibility and identify potential participants for the clinical trials. The establishment of requirements and methodology, addressing issues of data security and confidentiality, future data compatibility and interoperability and medico-legal aspects such as access controls and audit trails, led to a robust and useful system. The evaluation supports that the system is an acceptable tool for clinical, administrative, and research use and forms a useful part of the wider information architecture.

Systematic review of the methodological quality of clinical guideline development for the management of chronic disease in Europe.

PubMed

Knai, Cécile; Brusamento, Serena; Legido-Quigley, Helena; Saliba, Vanessa; Panteli, Dimitra; Turk, Eva; Car, Josip; McKee, Martin; Busse, Reinhard

2012-10-01

The use of evidence-based clinical guidelines is an essential component of chronic disease management. However, there is well-documented concern about variability in the quality of clinical guidelines, with evidence of persisting methodological shortcomings. The most widely accepted approach to assessing the quality of guidelines is the Appraisal of Guidelines for Research and Evaluation (AGREE) instrument. We have conducted a systematic review of the methodological quality (as assessed by AGREE) of clinical guidelines developed in Europe for the management of chronic diseases published since 2000. The systematic review was undertaken in accordance with the Cochrane methodology. The inclusion criteria were that studies should have appraised European clinical guidelines for certain selected chronic disorders using the AGREE instrument. We searched five databases (Cab Abstracts, EMBASE, MEDLINE, Trip and EPPI). Nine studies reported in 10 papers, analysing a total of 28 European guidelines from eight countries as well as pan-European, were included. There was considerable variation in the quality of clinical guidelines across the AGREE domains. The least well addressed domains were 'editorial independence' (with a mean domain score of 41%), 'applicability' (44%), 'stakeholder involvement' (55%), and 'rigour of development' (64%), while 'clarity of presentation' (80%) and 'scope and purpose' (84%) were less problematic. This review indicates that there is considerable scope for improvement in the methods used to develop clinical guidelines for the prevention, management and treatment of chronic diseases in Europe. Given the importance of decision support strategies such as clinical guidelines in chronic disease management, improvement measures should include the explicit and transparent involvement of key stakeholders (especially scientific experts, guideline users and methodological specialists) and consideration of the implications for guideline implementation and applicability early on in the process. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

A randomized controlled trial of a community health worker intervention in a population of patients with multiple chronic diseases: Study design and protocol

PubMed Central

Kangovi, Shreya; Mitra, Nandita; Turr, Lindsey; Huo, Hairong; Grande, David; Long, Judith A.

2017-01-01

Upstream interventions – e.g. housing programs and community health worker interventions-address socioeconomic and behavioral factors that influence health outcomes across diseases. Studying these types of interventions in clinical trials raises a methodological challenge: how should researchers measure the effect of an upstream intervention in a sample of patients with different diseases? This paper addresses this question using an illustrative protocol of a randomized controlled trial of collaborative-goal setting versus goal-setting plus community health worker support among patients multiple chronic diseases: diabetes, obesity, hypertension and tobacco dependence. At study enrollment, patients met with their primary care providers to select one of their chronic diseases to focus on during the study, and to collaboratively set a goal for that disease. Patients randomly assigned to a community health worker also received six months of support to address socioeconomic and behavioral barriers to chronic disease control. The primary hypothesis was that there would be differences in patients’ selected chronic disease control as measured by HbA1c, body mass index, systolic blood pressure and cigarettes per day, between the goal-setting alone and community health worker support arms. To test this hypothesis, we will conduct a stratum specific multivariate analysis of variance which allows all patients (regardless of their selected chronic disease) to be included in a single model for the primary outcome. Population health researchers can use this approach to measure clinical outcomes across diseases. PMID:27965180

Methodological issues associated with clinical trials in epilepsy.

PubMed

Ferlazzo, Edoardo; Sueri, Chiara; Gasparini, Sara; Russo, Emilio; Cianci, Vittoria; Ascoli, Michele; De Sarro, Giovambattista; Aguglia, Umberto

2017-10-01

despite methodological advances in epilepsy clinical trials, the proportion of patients reaching seizure-freedom has not substantially changed over the years. We review the main methodological limitations of current trials, the possible strategies to overcome these limits, and the issues that need to be addressed in next future. Area covered: references were identified by PubMed search until March 2017 and unpublished literature was searched on ClinicalTrials.gov. Add-on trials mainly involve refractory epilepsy subjects, reducing overall response to the investigational drug. The inclusion of subjects with earlier disease from less developed countries has partially allowed overcoming this limitation, but has introduced more random variability of results. Monotherapy trials rise methodological, economical, and ethical concerns with different regulatory requirements in European Union and in the United States of America. Newer trial designs, such as futility trials or 'time-to-event' design, have been implemented. Moreover, both add-on and monotherapy trials results might be affected by patient's ability to recognize and record seizures, and by randomness of seizures occurrence over time. Possible strategies to achieve more reliable outcomes are detailed. Expert commentary: clinical trial methodology needs to be optimized to better address regulatory agencies requirements and to encounter both patients' and clinicians' needs.

Intentional Modelling: A Process for Clinical Leadership Development in Mental Health Nursing.

PubMed

Ennis, Gary; Happell, Brenda; Reid-Searl, Kerry

2016-05-01

Clinical leadership is becoming more relevant for nurses, as the positive impact that it can have on the quality of care and outcomes for consumers is better understood and more clearly articulated in the literature. As clinical leadership continues to become more relevant, the need to gain an understanding of how clinical leaders in nursing develop will become increasingly important. While the attributes associated with effective clinical leadership are recognized in current literature there remains a paucity of research on how clinical leaders develop these attributes. This study utilized a grounded theory methodology to generate new insights into the experiences of peer identified clinical leaders in mental health nursing and the process of developing clinical leadership skills. Participants in this study were nurses working in a mental health setting who were identified as clinical leaders by their peers as opposed to identifying them by their role or organizational position. A process of intentional modeling emerged as the substantive theory identified in this study. Intentional modeling was described by participants in this study as a process that enabled them to purposefully identify models that assisted them in developing the characteristics of effective clinical leaders as well as allowing them to model these characteristics to others. Reflection on practice is an important contributor to intentional modelling. Intentional modelling could be developed as a framework for promoting knowledge and skill development in the area of clinical leadership.

Academic detailing can play a key role in assessing and implementing comparative effectiveness research findings.

PubMed

Fischer, Michael A; Avorn, Jerry

2012-10-01

Comparative effectiveness research evaluates the relative effectiveness, safety, and value of competing treatment options in clinically realistic settings. Such evaluations can be methodologically complex and difficult to interpret. There will be a growing need for critical evaluation of comparative effectiveness studies to assess the adequacy of their design and to put new information into a broader context. Equally important, this knowledge will have to be communicated to clinicians in a way that will actually change practice. We identify three challenges to effective dissemination of comparative effectiveness research findings: the difficulty of interpreting comparative effectiveness research data, the need for trusted sources of information, and the challenge of turning research results into clinical action. We suggest that academic detailing-direct outreach education that gives clinicians an accurate and unbiased synthesis of the best evidence for practice in a given clinical area-can translate comparative effectiveness research findings into actions that improve health care decision making and patient outcomes.

Multilingual Information Retrieval in Thoracic Radiology: Feasibility Study

PubMed Central

Castilla, André Coutinho; Furuie, Sérgio Shiguemi; Mendonça, Eneida A.

2014-01-01

Most of essential information contained on Electronic Medical Record is stored as text, imposing several difficulties on automated data extraction and retrieval. Natural language processing is an approach that can unlock clinical information from free texts. The proposed methodology uses the specialized natural language processor MEDLEE developed for English language. To use this processor on Portuguese medical texts, chest x-ray reports were Machine Translated into English. The result of serial coupling of MT an NLP is tagged text which needs further investigation for extracting clinical findings. The objective of this experiment was to investigate normal reports and reports with device description on a set of 165 chest x-ray reports. We obtained sensitivity and specificity of 1 and 0.71 for the first condition and 0.97 and 0.97 for the second respectively. The reference was formed by the opinion of two radiologists. The results of this experiment indicate the viability of extracting clinical findings from chest x-ray reports through coupling MT and NLP. PMID:17911745

A methodological evaluation of volumetric measurement techniques including three-dimensional imaging in breast surgery.

PubMed

Hoeffelin, H; Jacquemin, D; Defaweux, V; Nizet, J L

2014-01-01

Breast surgery currently remains very subjective and each intervention depends on the ability and experience of the operator. To date, no objective measurement of this anatomical region can codify surgery. In this light, we wanted to compare and validate a new technique for 3D scanning (LifeViz 3D) and its clinical application. We tested the use of the 3D LifeViz system (Quantificare) to perform volumetric calculations in various settings (in situ in cadaveric dissection, of control prostheses, and in clinical patients) and we compared this system to other techniques (CT scanning and Archimedes' principle) under the same conditions. We were able to identify the benefits (feasibility, safety, portability, and low patient stress) and limitations (underestimation of the in situ volume, subjectivity of contouring, and patient selection) of the LifeViz 3D system, concluding that the results are comparable with other measurement techniques. The prospects of this technology seem promising in numerous applications in clinical practice to limit the subjectivity of breast surgery.

A Methodological Evaluation of Volumetric Measurement Techniques including Three-Dimensional Imaging in Breast Surgery

PubMed Central

Hoeffelin, H.; Jacquemin, D.; Defaweux, V.; Nizet, J L.

2014-01-01

Breast surgery currently remains very subjective and each intervention depends on the ability and experience of the operator. To date, no objective measurement of this anatomical region can codify surgery. In this light, we wanted to compare and validate a new technique for 3D scanning (LifeViz 3D) and its clinical application. We tested the use of the 3D LifeViz system (Quantificare) to perform volumetric calculations in various settings (in situ in cadaveric dissection, of control prostheses, and in clinical patients) and we compared this system to other techniques (CT scanning and Archimedes' principle) under the same conditions. We were able to identify the benefits (feasibility, safety, portability, and low patient stress) and limitations (underestimation of the in situ volume, subjectivity of contouring, and patient selection) of the LifeViz 3D system, concluding that the results are comparable with other measurement techniques. The prospects of this technology seem promising in numerous applications in clinical practice to limit the subjectivity of breast surgery. PMID:24511536

Professional Socialization: A Grounded Theory of the Clinical Reasoning Processes That RNs and LPNs Use to Recognize Delirium.

PubMed

El Hussein, Mohamed; Hirst, Sandra; Osuji, Joseph

2017-08-01

Delirium is an acute disorder of attention and cognition. It affects half of older adults in acute care settings and is a cause of increasing mortality and costs. Registered nurses (RNs) and licensed practical nurses (LPNs) frequently fail to recognize delirium. The goals of this research were to identify the reasoning processes that RNs and LPNs use to recognize delirium, to compare their reasoning processes, and to generate a theory that explains their clinical reasoning processes. Theoretical sampling was employed to elicit data from 28 participants using grounded theory methodology. Theoretical coding culminated in the emergence of Professional Socialization as the substantive theory. Professional Socialization emerged from participants' responses and was based on two social processes, specifically reasoning to uncover and reasoning to report. Professional Socialization makes explicit the similarities and variations in the clinical reasoning processes between RNs and LPNs and highlights their main concerns when interacting with delirious patients.

Proceedings of the 2016 Clinical Nutrition Week Research Workshop-The Optimal Dose of Protein Provided to Critically Ill Patients.

PubMed

Heyland, Daren K; Rooyakers, Olav; Mourtzakis, Marina; Stapleton, Renee D

2017-02-01

Recent literature has created considerable confusion about the optimal amount of protein/amino acids that should be provided to the critically ill patient. In fact, the evidentiary basis that directly tries to answer this question is relatively small. As a clinical nutrition research community, there is an urgent need to develop the optimal methods to assess the impact of exogenous protein/amino acid administration in the intensive care unit setting. That assessment can be conducted at various levels: (1) impact on stress response pathways, (2) impact on muscle synthesis and protein balance, (3) impact on muscle mass and function, and (4) impact on the patient's recovery. The objective of this research workshop was to review current literature relating to protein/amino acid administration for the critically ill patient and clinical outcomes and to discuss the key measurement and methodological features of future studies that should be done to inform the optimal protein/amino acid dose provided to critically ill patients.

78 FR 4369 - Rates for Interstate Inmate Calling Services

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-22

.... Marginal Location Methodology. In 2008, ICS providers submitted the ICS Provider Proposal for ICS rates. The ICS Provider Proposal uses the ``marginal location'' methodology, previously adopted by the... ``marginal location'' methodology provides a ``basis for rates that represent `fair compensation' as set...

Personalized Clinical Diagnosis in Data Bases for Treatment Support in Phthisiology.

PubMed

Lugovkina, T K; Skornyakov, S N; Golubev, D N; Egorov, E A; Medvinsky, I D

2016-01-01

The decision-making is a key event in the clinical practice. The program products with clinical decision support models in electronic data-base as well as with fixed decision moments of the real clinical practice and treatment results are very actual instruments for improving phthisiological practice and may be useful in the severe cases caused by the resistant strains of Mycobacterium tuberculosis. The methodology for gathering and structuring of useful information (critical clinical signals for decisions) is described. Additional coding of clinical diagnosis characteristics was implemented for numeric reflection of the personal situations. The created methodology for systematization and coding Clinical Events allowed to improve the clinical decision models for better clinical results.

Bayesian methodology for the design and interpretation of clinical trials in critical care medicine: a primer for clinicians.

PubMed

Kalil, Andre C; Sun, Junfeng

2014-10-01

To review Bayesian methodology and its utility to clinical decision making and research in the critical care field. Clinical, epidemiological, and biostatistical studies on Bayesian methods in PubMed and Embase from their inception to December 2013. Bayesian methods have been extensively used by a wide range of scientific fields, including astronomy, engineering, chemistry, genetics, physics, geology, paleontology, climatology, cryptography, linguistics, ecology, and computational sciences. The application of medical knowledge in clinical research is analogous to the application of medical knowledge in clinical practice. Bedside physicians have to make most diagnostic and treatment decisions on critically ill patients every day without clear-cut evidence-based medicine (more subjective than objective evidence). Similarly, clinical researchers have to make most decisions about trial design with limited available data. Bayesian methodology allows both subjective and objective aspects of knowledge to be formally measured and transparently incorporated into the design, execution, and interpretation of clinical trials. In addition, various degrees of knowledge and several hypotheses can be tested at the same time in a single clinical trial without the risk of multiplicity. Notably, the Bayesian technology is naturally suited for the interpretation of clinical trial findings for the individualized care of critically ill patients and for the optimization of public health policies. We propose that the application of the versatile Bayesian methodology in conjunction with the conventional statistical methods is not only ripe for actual use in critical care clinical research but it is also a necessary step to maximize the performance of clinical trials and its translation to the practice of critical care medicine.

Clinical epidemiology in the era of big data: new opportunities, familiar challenges.

PubMed

Ehrenstein, Vera; Nielsen, Henrik; Pedersen, Alma B; Johnsen, Søren P; Pedersen, Lars

2017-01-01

Routinely recorded health data have evolved from mere by-products of health care delivery or billing into a powerful research tool for studying and improving patient care through clinical epidemiologic research. Big data in the context of epidemiologic research means large interlinkable data sets within a single country or networks of multinational databases. Several Nordic, European, and other multinational collaborations are now well established. Advantages of big data for clinical epidemiology include improved precision of estimates, which is especially important for reassuring ("null") findings; ability to conduct meaningful analyses in subgroup of patients; and rapid detection of safety signals. Big data will also provide new possibilities for research by enabling access to linked information from biobanks, electronic medical records, patient-reported outcome measures, automatic and semiautomatic electronic monitoring devices, and social media. The sheer amount of data, however, does not eliminate and may even amplify systematic error. Therefore, methodologies addressing systematic error, clinical knowledge, and underlying hypotheses are more important than ever to ensure that the signal is discernable behind the noise.

Prospects for a Clinical Science of Mindfulness-Based Intervention

PubMed Central

Dimidjian, Sona; Segal, Zindel V.

2017-01-01

Mindfulness-based interventions are at a pivotal point in their future development. Spurred on by an ever-increasing number of studies and breadth of clinical application, the value of such approaches may appear self-evident. We contend, however, that the public health impact of mindfulness-based interventions can be enhanced significantly by situating this work in a broader framework of clinical psychological science. Utilizing the National Institute of Health stage model (Onken, Carroll, Shoham, Cuthbert, & Riddle, 2014), we map the evidence base for mindfulness-based cognitive therapy and mindfulness-based stress reduction as exemplars of mindfulness-based interventions. From this perspective, we suggest that important gaps in the current evidence base become apparent and, furthermore, that generating more of the same types of studies without addressing such gaps will limit the relevance and reach of these interventions. We offer a set of 7 recommendations that promote an integrated approach to core research questions, enhanced methodological quality of individual studies, and increased logical links among stages of clinical translation in order to increase the potential of MBIs to impact positively the mental health needs of individuals and communities. PMID:26436311

Clinical epidemiology in the era of big data: new opportunities, familiar challenges

PubMed Central

Ehrenstein, Vera; Nielsen, Henrik; Pedersen, Alma B; Johnsen, Søren P; Pedersen, Lars

2017-01-01

Routinely recorded health data have evolved from mere by-products of health care delivery or billing into a powerful research tool for studying and improving patient care through clinical epidemiologic research. Big data in the context of epidemiologic research means large interlinkable data sets within a single country or networks of multinational databases. Several Nordic, European, and other multinational collaborations are now well established. Advantages of big data for clinical epidemiology include improved precision of estimates, which is especially important for reassuring (“null”) findings; ability to conduct meaningful analyses in subgroup of patients; and rapid detection of safety signals. Big data will also provide new possibilities for research by enabling access to linked information from biobanks, electronic medical records, patient-reported outcome measures, automatic and semiautomatic electronic monitoring devices, and social media. The sheer amount of data, however, does not eliminate and may even amplify systematic error. Therefore, methodologies addressing systematic error, clinical knowledge, and underlying hypotheses are more important than ever to ensure that the signal is discernable behind the noise. PMID:28490904

Strategic performance management: development of a performance measurement system at the Mayo Clinic.

PubMed

Curtright, J W; Stolp-Smith, S C; Edell, E S

2000-01-01

Managing and measuring performance become exceedingly complex as healthcare institutions evolve into integrated health systems comprised of hospitals, outpatient clinics and surgery centers, nursing homes, and home health services. Leaders of integrated health systems need to develop a methodology and system that align organizational strategies with performance measurement and management. To meet this end, multiple healthcare organizations embrace the performance-indicators reporting system known as a "balanced scorecard" or a "dashboard report." This discrete set of macrolevel indicators gives senior management a fast but comprehensive glimpse of the organization's performance in meeting its quality, operational, and financial goals. The leadership of outpatient operations for Mayo Clinic in Rochester, Minnesota built on this concept by creating a performance management and measurement system that monitors and reports how well the organization achieves its performance goals. Internal stakeholders identified metrics to measure performance in each key category. Through these metrics, the organization links Mayo Clinic's vision, primary value, core principles, and day-to-day operations by monitoring key performance indicators on a weekly, monthly, or quarterly basis.

Setting up a cohort study in speech and language therapy: lessons from The UK Cleft Collective Speech and Language (CC-SL) study.

PubMed

Wren, Yvonne; Humphries, Kerry; Stock, Nicola Marie; Rumsey, Nichola; Lewis, Sarah; Davies, Amy; Bennett, Rhiannon; Sandy, Jonathan

2018-05-01

Efforts to increase the evidence base in speech and language therapy are often limited by methodological factors that have restricted the strength of the evidence to the lower levels of the evidence hierarchy. Where higher graded studies, such as randomized controlled trials, have been carried out, it has sometimes been difficult to obtain sufficient power to detect a potential effect of intervention owing to small sample sizes or heterogeneity in the participants. With certain clinical groups such as cleft lip and palate, systematic reviews of intervention studies have shown that there is no robust evidence to support the efficacy of any one intervention protocol over another. To describe the setting up of an observational clinical cohort study and to present this as an alternative design for answering research questions relating to prevalence, risk factors and outcomes from intervention. The Cleft Collective Speech and Language (CC-SL) study is a national cohort study of children born with cleft palate. Working in partnership with regional clinical cleft centres, a sample size of over 600 children and 600 parents is being recruited and followed up from birth to age 5 years. Variables being collected include demographic, psychological, surgical, hearing, and speech and language data. The process of setting up the study has led to the creation of a unique, large-scale data set which is available for researchers to access now and in future. As well as exploring predictive factors, the data can be used to explore the impact of interventions in relation to individual differences. Findings from these investigations can be used to provide information on sample criteria and definitions of intervention and dosage which can be used in future trials. The observational cohort study is a useful alternative design to explore questions around prevalence, risk factors and intervention for clinical groups where robust research data are not yet available. Findings from such a study can be used to guide service-delivery decisions and to determine power for future clinical trials. © 2017 Royal College of Speech and Language Therapists.

[Methodological aspects of integrated care pathways].

PubMed

Gomis, R; Mata Cases, M; Mauricio Puente, D; Artola Menéndez, S; Ena Muñoz, J; Mediavilla Bravo, J J; Miranda Fernández-Santos, C; Orozco Beltrán, D; Rodríguez Mañas, L; Sánchez Villalba, C; Martínez, J A

An Integrated Healthcare Pathway (PAI) is a tool which has as its aim to increase the effectiveness of clinical performance through greater coordination and to ensure continuity of care. PAI places the patient as the central focus of the organisation of health services. It is defined as the set of activities carried out by the health care providers in order to increase the level of health and satisfaction of the population receiving services. The development of a PAI requires the analysis of the flow of activities, the inter-relationships between professionals and care teams, and patient expectations. The methodology for the development of a PAI is presented and discussed in this article, as well as the success factors for its definition and its effective implementation. It also explains, as an example, the recent PAI for Hypoglycaemia in patients with Type 2 Diabetes Mellitus developed by a multidisciplinary team and supported by several scientific societies. Copyright © 2017 SECA. Publicado por Elsevier España, S.L.U. All rights reserved.

Yoga in the schools: a systematic review of the literature.

PubMed

Serwacki, Michelle L; Cook-Cottone, Catherine

2012-01-01

The objective of this research was to examine the evidence for delivering yoga-based interventions in schools. An electronic literature search was conducted to identify peer-reviewed, published studies in which yoga and a meditative component (breathing practices or meditation) were taught to youths in a school setting. Pilot studies, single cohort, quasi-experimental, and randomized clinical trials were considered. quality was evaluated and summarized. Twelve published studies were identified. Samples for which yoga was implemented as an intervention included youths with autism, intellectual disability, learning disability, and emotional disturbance, as well as typically developing youths. Although effects of participating in school-based yoga programs appeared to be beneficial for the most part, methodological limitations, including lack of randomization, small samples, limited detail regarding the intervention, and statistical ambiguities curtailed the ability to provide definitive conclusions or recommendations. Findings speak to the need for greater methodological rigor and an increased understanding of the mechanisms of success for school-based yoga interventions.

Identifying clinically disruptive International Classification of Diseases 10th Revision Clinical Modification conversions to mitigate financial costs using an online tool.

PubMed

Venepalli, Neeta K; Qamruzzaman, Yusuf; Li, Jianrong John; Lussier, Yves A; Boyd, Andrew D

2014-03-01

To quantify coding ambiguity in International Classification of Diseases Ninth Revision Clinical Modification conversions (ICD-9-CM) to ICD-10-CM mappings for hematology-oncology diagnoses within an Illinois Medicaid database and an academic cancer center database (University of Illinois Cancer Center [UICC]) with the goal of anticipating challenges during ICD-10-CM transition. One data set of ICD-9-CM diagnosis codes came from the 2010 Illinois Department of Medicaid, filtered for diagnoses generated by hematology-oncology providers. The other data set of ICD-9-CM diagnosis codes came from UICC. Using a translational methodology via the Motif Web portal ICD-9-CM conversion tool, ICD-9-CM to ICD-10-CM code conversions were graphically mapped and evaluated for clinical loss of information. The transition to ICD-10-CM led to significant information loss, affecting 8% of total Medicaid codes and 1% of UICC codes; 39 ICD-9-CM codes with information loss accounted for 2.9% of total Medicaid reimbursements and 5.3% of UICC billing charges. Prior work stated hematology-oncology would be the least affected medical specialty. However, information loss affecting 5% of billing costs could evaporate the operating margin of a practice. By identifying codes at risk for complex transitions, the analytic tools described can be replicated for oncology practices to forecast areas requiring additional training and resource allocation. In summary, complex transitions and diagnosis codes associated with information loss within clinical oncology require additional attention during the transition to ICD-10-CM.

Ambulatory Morning Report: A Case-Based Method of Teaching EBM Through Experiential Learning.

PubMed

Luciano, Gina L; Visintainer, Paul F; Kleppel, Reva; Rothberg, Michael B

2016-02-01

Evidence-based medicine (EBM) skills are important to daily practice, but residents generally feel unskilled incorporating EBM into practice. The Kolb experiential learning theory, as applied to curricular planning, offers a unique methodology to help learners build an EBM skill set based on clinical experiences. We sought to blend the learner-centered, case-based merits of the morning report with an experientially based EBM curriculum. We describe and evaluate a patient-centered ambulatory morning report combining the User's Guides to the Medical Literature approach to EBM and experiential learning theory in the internal medicine department at Baystate Medical Center. The Kolb experiential learning theory postulates that experience transforms knowledge; within that premise we designed a curriculum to build EBM skills incorporating residents' patient encounters. By developing structured clinical questions based on recent clinical problems, residents activate prior knowledge. Residents acquire new knowledge through selection and evaluation of an article that addresses the structured clinical questions. Residents then apply and use new knowledge in future patient encounters. To assess the curriculum, we designed an 18-question EBM test, which addressed applied knowledge and EBM skills based on the User's Guides approach. Of the 66 residents who could participate in the curriculum, 61 (92%) completed the test. There was a modest improvement in EBM knowledge, primarily during the first year of training. Our experiential curriculum teaches EBM skills essential to clinical practice. The curriculum differs from traditional EBM curricula in that ours blends experiential learning with an EBM skill set; learners use new knowledge in real time.

Quantifying Data Quality for Clinical Trials Using Electronic Data Capture

PubMed Central

Nahm, Meredith L.; Pieper, Carl F.; Cunningham, Maureen M.

2008-01-01

Background Historically, only partial assessments of data quality have been performed in clinical trials, for which the most common method of measuring database error rates has been to compare the case report form (CRF) to database entries and count discrepancies. Importantly, errors arising from medical record abstraction and transcription are rarely evaluated as part of such quality assessments. Electronic Data Capture (EDC) technology has had a further impact, as paper CRFs typically leveraged for quality measurement are not used in EDC processes. Methods and Principal Findings The National Institute on Drug Abuse Treatment Clinical Trials Network has developed, implemented, and evaluated methodology for holistically assessing data quality on EDC trials. We characterize the average source-to-database error rate (14.3 errors per 10,000 fields) for the first year of use of the new evaluation method. This error rate was significantly lower than the average of published error rates for source-to-database audits, and was similar to CRF-to-database error rates reported in the published literature. We attribute this largely to an absence of medical record abstraction on the trials we examined, and to an outpatient setting characterized by less acute patient conditions. Conclusions Historically, medical record abstraction is the most significant source of error by an order of magnitude, and should be measured and managed during the course of clinical trials. Source-to-database error rates are highly dependent on the amount of structured data collection in the clinical setting and on the complexity of the medical record, dependencies that should be considered when developing data quality benchmarks. PMID:18725958

Risk factors for invasive fungal disease in critically ill adult patients: a systematic review.

PubMed

Muskett, Hannah; Shahin, Jason; Eyres, Gavin; Harvey, Sheila; Rowan, Kathy; Harrison, David

2011-01-01

Over 5,000 cases of invasive Candida species infections occur in the United Kingdom each year, and around 40% of these cases occur in critical care units. Invasive fungal disease (IFD) in critically ill patients is associated with increased morbidity and mortality at a cost to both the individual and the National Health Service. In this paper, we report the results of a systematic review performed to identify and summarise the important risk factors derived from published multivariable analyses, risk prediction models and clinical decision rules for IFD in critically ill adult patients to inform the primary data collection for the Fungal Infection Risk Evaluation Study. An internet search was performed to identify articles which investigated risk factors, risk prediction models or clinical decisions rules for IFD in critically ill adult patients. Eligible articles were identified in a staged process and were assessed by two investigators independently. The methodological quality of the reporting of the eligible articles was assessed using a set of questions addressing both general and statistical methodologies. Thirteen articles met the inclusion criteria, of which eight articles examined risk factors, four developed a risk prediction model or clinical decision rule and one evaluated a clinical decision rule. Studies varied in terms of objectives, risk factors, definitions and outcomes. The following risk factors were found in multiple studies to be significantly associated with IFD: surgery, total parenteral nutrition, fungal colonisation, renal replacement therapy, infection and/or sepsis, mechanical ventilation, diabetes, and Acute Physiology and Chronic Health Evaluation II (APACHE II) or APACHE III score. Several other risk factors were also found to be statistically significant in single studies only. Risk factor selection process and modelling strategy also varied across studies, and sample sizes were inadequate for obtaining reliable estimates. This review shows a number of risk factors to be significantly associated with the development of IFD in critically ill adults. Methodological limitations were identified in the design and conduct of studies in this area, and caution should be used in their interpretation.

DMET-Miner: Efficient discovery of association rules from pharmacogenomic data.

PubMed

Agapito, Giuseppe; Guzzi, Pietro H; Cannataro, Mario

2015-08-01

Microarray platforms enable the investigation of allelic variants that may be correlated to phenotypes. Among those, the Affymetrix DMET (Drug Metabolism Enzymes and Transporters) platform enables the simultaneous investigation of all the genes that are related to drug absorption, distribution, metabolism and excretion (ADME). Although recent studies demonstrated the effectiveness of the use of DMET data for studying drug response or toxicity in clinical studies, there is a lack of tools for the automatic analysis of DMET data. In a previous work we developed DMET-Analyzer, a methodology and a supporting platform able to automatize the statistical study of allelic variants, that has been validated in several clinical studies. Although DMET-Analyzer is able to correlate a single variant for each probe (related to a portion of a gene) through the use of the Fisher test, it is unable to discover multiple associations among allelic variants, due to its underlying statistic analysis strategy that focuses on a single variant for each time. To overcome those limitations, here we propose a new analysis methodology for DMET data based on Association Rules mining, and an efficient implementation of this methodology, named DMET-Miner. DMET-Miner extends the DMET-Analyzer tool with data mining capabilities and correlates the presence of a set of allelic variants with the conditions of patient's samples by exploiting association rules. To face the high number of frequent itemsets generated when considering large clinical studies based on DMET data, DMET-Miner uses an efficient data structure and implements an optimized search strategy that reduces the search space and the execution time. Preliminary experiments on synthetic DMET datasets, show how DMET-Miner outperforms off-the-shelf data mining suites such as the FP-Growth algorithms available in Weka and RapidMiner. To demonstrate the biological relevance of the extracted association rules and the effectiveness of the proposed approach from a medical point of view, some preliminary studies on a real clinical dataset are currently under medical investigation. Copyright © 2015 Elsevier Inc. All rights reserved.

Risk factors for invasive fungal disease in critically ill adult patients: a systematic review

PubMed Central

2011-01-01

Introduction Over 5,000 cases of invasive Candida species infections occur in the United Kingdom each year, and around 40% of these cases occur in critical care units. Invasive fungal disease (IFD) in critically ill patients is associated with increased morbidity and mortality at a cost to both the individual and the National Health Service. In this paper, we report the results of a systematic review performed to identify and summarise the important risk factors derived from published multivariable analyses, risk prediction models and clinical decision rules for IFD in critically ill adult patients to inform the primary data collection for the Fungal Infection Risk Evaluation Study. Methods An internet search was performed to identify articles which investigated risk factors, risk prediction models or clinical decisions rules for IFD in critically ill adult patients. Eligible articles were identified in a staged process and were assessed by two investigators independently. The methodological quality of the reporting of the eligible articles was assessed using a set of questions addressing both general and statistical methodologies. Results Thirteen articles met the inclusion criteria, of which eight articles examined risk factors, four developed a risk prediction model or clinical decision rule and one evaluated a clinical decision rule. Studies varied in terms of objectives, risk factors, definitions and outcomes. The following risk factors were found in multiple studies to be significantly associated with IFD: surgery, total parenteral nutrition, fungal colonisation, renal replacement therapy, infection and/or sepsis, mechanical ventilation, diabetes, and Acute Physiology and Chronic Health Evaluation II (APACHE II) or APACHE III score. Several other risk factors were also found to be statistically significant in single studies only. Risk factor selection process and modelling strategy also varied across studies, and sample sizes were inadequate for obtaining reliable estimates. Conclusions This review shows a number of risk factors to be significantly associated with the development of IFD in critically ill adults. Methodological limitations were identified in the design and conduct of studies in this area, and caution should be used in their interpretation. PMID:22126425

Potential Impact of Rapid Blood Culture Testing for Gram-Positive Bacteremia in Japan with the Verigene Gram-Positive Blood Culture Test

PubMed Central

Matsuda, Mari; Iguchi, Shigekazu; Mizutani, Tomonori; Hiramatsu, Keiichi; Tega-Ishii, Michiru; Sansaka, Kaori; Negishi, Kenta; Shimada, Kimie; Umemura, Jun; Notake, Shigeyuki; Yanagisawa, Hideji; Yabusaki, Reiko; Araoka, Hideki; Yoneyama, Akiko

2017-01-01

Background. Early detection of Gram-positive bacteremia and timely appropriate antimicrobial therapy are required for decreasing patient mortality. The purpose of our study was to evaluate the performance of the Verigene Gram-positive blood culture assay (BC-GP) in two special healthcare settings and determine the potential impact of rapid blood culture testing for Gram-positive bacteremia within the Japanese healthcare delivery system. Furthermore, the study included simulated blood cultures, which included a library of well-characterized methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE) isolates reflecting different geographical regions in Japan. Methods. A total 347 BC-GP assays were performed on clinical and simulated blood cultures. BC-GP results were compared to results obtained by reference methods for genus/species identification and detection of resistance genes using molecular and MALDI-TOF MS methodologies. Results. For identification and detection of resistance genes at two clinical sites and simulated blood cultures, overall concordance of BC-GP with reference methods was 327/347 (94%). The time for identification and antimicrobial resistance detection by BC-GP was significantly shorter compared to routine testing especially at the cardiology hospital, which does not offer clinical microbiology services on weekends and holidays. Conclusion. BC-GP generated accurate identification and detection of resistance markers compared with routine laboratory methods for Gram-positive organisms in specialized clinical settings providing more rapid results than current routine testing. PMID:28316631

Clinical Criteria Versus a Possible Research Case Definition in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis

PubMed Central

Jason, Leonard A.; McManimen, Stephanie; Sunnquist, Madison; Newton, Julia L.; Strand, Elin Bolle

2017-01-01

Background The Institute of Medicine (IOM) recently developed clinical criteria for what had been known as chronic fatigue syndrome (CFS). Given the broad nature of the clinical IOM criteria, there is a need for a research definition that would select a more homogenous and impaired group of patients than the IOM clinical criteria. At the present time, it is unclear what will serve as the research definition. Purpose The current study focused on a research definition which selected homebound individuals who met the four IOM criteria, excluding medical and psychiatric co-morbidities. Methods Our research criteria were compared to those participants meeting the IOM criteria. Those not meeting either of these criteria sets were placed in a separate group defined by 6 or more months of fatigue. Data analyzed were from the DePaul Symptom Questionnaire and the SF-36. Due to unequal sample sizes and variances, Welch’s F tests and Games-Howell post hoc tests were conducted. Results Using a large database of over 1,000 patients from several countries, we found that those meeting a more restrictive research definition were even more impaired and more symptomatic than those meeting criteria for the other two groups. Conclusion Deciding on a particular research case definition would allow researchers to select more comparable patient samples across settings, and this would represent one of the most significant methodologic advances for this field of study. PMID:29062593

Clinical trials in palliative care: a systematic review of their methodological characteristics and of the quality of their reporting.

PubMed

Bouça-Machado, Raquel; Rosário, Madalena; Alarcão, Joana; Correia-Guedes, Leonor; Abreu, Daisy; Ferreira, Joaquim J

2017-01-25

Over the past decades there has been a significant increase in the number of published clinical trials in palliative care. However, empirical evidence suggests that there are methodological problems in the design and conduct of studies, which raises questions about the validity and generalisability of the results and of the strength of the available evidence. We sought to evaluate the methodological characteristics and assess the quality of reporting of clinical trials in palliative care. We performed a systematic review of published clinical trials assessing therapeutic interventions in palliative care. Trials were identified using MEDLINE (from its inception to February 2015). We assessed methodological characteristics and describe the quality of reporting using the Cochrane Risk of Bias tool. We retrieved 107 studies. The most common medical field studied was oncology, and 43.9% of trials evaluated pharmacological interventions. Symptom control and physical dimensions (e.g. intervention on pain, breathlessness, nausea) were the palliative care-specific issues most studied. We found under-reporting of key information in particular on random sequence generation, allocation concealment, and blinding. While the number of clinical trials in palliative care has increased over time, methodological quality remains suboptimal. This compromises the quality of studies. Therefore, a greater effort is needed to enable the appropriate performance of future studies and increase the robustness of evidence-based medicine in this important field.

Assessing Communication Skills of Medical Students in Objective Structured Clinical Examinations (OSCE) - A Systematic Review of Rating Scales

PubMed Central

Cömert, Musa; Zill, Jördis Maria; Christalle, Eva; Dirmaier, Jörg; Härter, Martin; Scholl, Isabelle

2016-01-01

Background Teaching and assessment of communication skills have become essential in medical education. The Objective Structured Clinical Examination (OSCE) has been found as an appropriate means to assess communication skills within medical education. Studies have demonstrated the importance of a valid assessment of medical students’ communication skills. Yet, the validity of the performance scores depends fundamentally on the quality of the rating scales used in an OSCE. Thus, this systematic review aimed at providing an overview of existing rating scales, describing their underlying definition of communication skills, determining the methodological quality of psychometric studies and the quality of psychometric properties of the identified rating scales. Methods We conducted a systematic review to identify psychometrically tested rating scales, which have been applied in OSCE settings to assess communication skills of medical students. Our search strategy comprised three databases (EMBASE, PsycINFO, and PubMed), reference tracking and consultation of experts. We included studies that reported psychometric properties of communication skills assessment rating scales used in OSCEs by examiners only. The methodological quality of included studies was assessed using the COnsensus based Standards for the selection of health status Measurement INstruments (COSMIN) checklist. The quality of psychometric properties was evaluated using the quality criteria of Terwee and colleagues. Results Data of twelve studies reporting on eight rating scales on communication skills assessment in OSCEs were included. Five of eight rating scales were explicitly developed based on a specific definition of communication skills. The methodological quality of studies was mainly poor. The psychometric quality of the eight rating scales was mainly intermediate. Discussion Our results reveal that future psychometric evaluation studies focusing on improving the methodological quality are needed in order to yield psychometrically sound results of the OSCEs assessing communication skills. This is especially important given that most OSCE rating scales are used for summative assessment, and thus have an impact on medical students’ academic success. PMID:27031506

Assessing Communication Skills of Medical Students in Objective Structured Clinical Examinations (OSCE)--A Systematic Review of Rating Scales.

PubMed

Cömert, Musa; Zill, Jördis Maria; Christalle, Eva; Dirmaier, Jörg; Härter, Martin; Scholl, Isabelle

2016-01-01

Teaching and assessment of communication skills have become essential in medical education. The Objective Structured Clinical Examination (OSCE) has been found as an appropriate means to assess communication skills within medical education. Studies have demonstrated the importance of a valid assessment of medical students' communication skills. Yet, the validity of the performance scores depends fundamentally on the quality of the rating scales used in an OSCE. Thus, this systematic review aimed at providing an overview of existing rating scales, describing their underlying definition of communication skills, determining the methodological quality of psychometric studies and the quality of psychometric properties of the identified rating scales. We conducted a systematic review to identify psychometrically tested rating scales, which have been applied in OSCE settings to assess communication skills of medical students. Our search strategy comprised three databases (EMBASE, PsycINFO, and PubMed), reference tracking and consultation of experts. We included studies that reported psychometric properties of communication skills assessment rating scales used in OSCEs by examiners only. The methodological quality of included studies was assessed using the COnsensus based Standards for the selection of health status Measurement INstruments (COSMIN) checklist. The quality of psychometric properties was evaluated using the quality criteria of Terwee and colleagues. Data of twelve studies reporting on eight rating scales on communication skills assessment in OSCEs were included. Five of eight rating scales were explicitly developed based on a specific definition of communication skills. The methodological quality of studies was mainly poor. The psychometric quality of the eight rating scales was mainly intermediate. Our results reveal that future psychometric evaluation studies focusing on improving the methodological quality are needed in order to yield psychometrically sound results of the OSCEs assessing communication skills. This is especially important given that most OSCE rating scales are used for summative assessment, and thus have an impact on medical students' academic success.

A misleading review of response bias: comment on McGrath, Mitchell, Kim, and Hough (2010).

PubMed

Rohling, Martin L; Larrabee, Glenn J; Greiffenstein, Manfred F; Ben-Porath, Yossef S; Lees-Haley, Paul; Green, Paul; Greve, Kevin W

2011-07-01

In the May 2010 issue of Psychological Bulletin, R. E. McGrath, M. Mitchell, B. H. Kim, and L. Hough published an article entitled "Evidence for Response Bias as a Source of Error Variance in Applied Assessment" (pp. 450-470). They argued that response bias indicators used in a variety of settings typically have insufficient data to support such use in everyday clinical practice. Furthermore, they claimed that despite 100 years of research into the use of response bias indicators, "a sufficient justification for [their] use… in applied settings remains elusive" (p. 450). We disagree with McGrath et al.'s conclusions. In fact, we assert that the relevant and voluminous literature that has addressed the issues of response bias substantiates validity of these indicators. In addition, we believe that response bias measures should be used in clinical and research settings on a regular basis. Finally, the empirical evidence for the use of response bias measures is strongest in clinical neuropsychology. We argue that McGrath et al.'s erroneous perspective on response bias measures is a result of 3 errors in their research methodology: (a) inclusion criteria for relevant studies that are too narrow; (b) errors in interpreting results of the empirical research they did include; (c) evidence of a confirmatory bias in selectively citing the literature, as evidence of moderation appears to have been overlooked. Finally, their acknowledging experts in the field who might have highlighted these errors prior to publication may have prevented critiques during the review process.

Malnutrition in Hospitalized Pediatric Patients: Assessment, Prevalence, and Association to Adverse Outcomes.

PubMed

Daskalou, Efstratia; Galli-Tsinopoulou, Assimina; Karagiozoglou-Lampoudi, Thomais; Augoustides-Savvopoulou, Persefone

2016-01-01

Malnutrition is a frequent finding in pediatric health care settings in the form of undernutrition or excess body weight. Its increasing prevalence and impact on overall health status, which is reflected in the adverse outcomes, renders imperative the application of commonly accepted and evidence-based practices and tools by health care providers. Nutrition risk screening on admission and nutrition status evaluation are key points during clinical management of hospitalized pediatric patients, in order to prevent health deterioration that can lead to serious complications and growth consequences. In addition, anthropometric data based on commonly accepted universal growth standards can give accurate results for nutrition status. Both nutrition risk screening and nutrition status assessment are techniques that should be routinely implemented, based on commonly accepted growth standards and methodology, and linked to clinical outcomes. The aim of the present review was to address the issue of hospital malnutrition in pediatric settings in terms of prevalence, outline nutrition status evaluation and nutrition screening process using different criteria and available tools, and present its relationship with outcome measures. Key teaching points • Malnutrition-underweight or excess body weight-is a frequent imbalance in pediatric settings that affects physical growth and results in undesirable clinical outcomes. • Anthropometry interpretation through growth charts and nutrition screening are cornerstones for the assessment of malnutrition.To date no commonly accepted anthropometric criteria or nutrition screening tools are used in hospitalized pediatric patients. • Commonly accepted nutrition status and screening processes based on the World Health Organization's growth standards can contribute to the overall hospital nutrition care of pediatric patients.

Segmentation methodology for automated classification and differentiation of soft tissues in multiband images of high-resolution ultrasonic transmission tomography.

PubMed

Jeong, Jeong-Won; Shin, Dae C; Do, Synho; Marmarelis, Vasilis Z

2006-08-01

This paper presents a novel segmentation methodology for automated classification and differentiation of soft tissues using multiband data obtained with the newly developed system of high-resolution ultrasonic transmission tomography (HUTT) for imaging biological organs. This methodology extends and combines two existing approaches: the L-level set active contour (AC) segmentation approach and the agglomerative hierarchical kappa-means approach for unsupervised clustering (UC). To prevent the trapping of the current iterative minimization AC algorithm in a local minimum, we introduce a multiresolution approach that applies the level set functions at successively increasing resolutions of the image data. The resulting AC clusters are subsequently rearranged by the UC algorithm that seeks the optimal set of clusters yielding the minimum within-cluster distances in the feature space. The presented results from Monte Carlo simulations and experimental animal-tissue data demonstrate that the proposed methodology outperforms other existing methods without depending on heuristic parameters and provides a reliable means for soft tissue differentiation in HUTT images.

How to write a surgical clinical research protocol: literature review and practical guide.

PubMed

Rosenthal, Rachel; Schäfer, Juliane; Briel, Matthias; Bucher, Heiner C; Oertli, Daniel; Dell-Kuster, Salome

2014-02-01

The study protocol is the core document of every clinical research project. Clinical research in studies involving surgical interventions presents some specific challenges, which need to be accounted for and described in the study protocol. The aim of this review is to provide a practical guide for developing a clinical study protocol for surgical interventions with a focus on methodologic issues. On the basis of an in-depth literature search of methodologic literature and on some cardinal published surgical trials and observational studies, the authors provides a 10-step guide for developing a clinical study protocol in surgery. This practical guide outlines key methodologic issues important when planning an ethically and scientifically sound research project involving surgical interventions, with the ultimate goal of providing high-level evidence relevant for health care decision making in surgery. Copyright © 2014 Elsevier Inc. All rights reserved.

Application of machine learning classification for structural brain MRI in mood disorders: Critical review from a clinical perspective.

PubMed

Kim, Yong-Ku; Na, Kyoung-Sae

2018-01-03

Mood disorders are a highly prevalent group of mental disorders causing substantial socioeconomic burden. There are various methodological approaches for identifying the underlying mechanisms of the etiology, symptomatology, and therapeutics of mood disorders; however, neuroimaging studies have provided the most direct evidence for mood disorder neural substrates by visualizing the brains of living individuals. The prefrontal cortex, hippocampus, amygdala, thalamus, ventral striatum, and corpus callosum are associated with depression and bipolar disorder. Identifying the distinct and common contributions of these anatomical regions to depression and bipolar disorder have broadened and deepened our understanding of mood disorders. However, the extent to which neuroimaging research findings contribute to clinical practice in the real-world setting is unclear. As traditional or non-machine learning MRI studies have analyzed group-level differences, it is not possible to directly translate findings from research to clinical practice; the knowledge gained pertains to the disorder, but not to individuals. On the other hand, a machine learning approach makes it possible to provide individual-level classifications. For the past two decades, many studies have reported on the classification accuracy of machine learning-based neuroimaging studies from the perspective of diagnosis and treatment response. However, for the application of a machine learning-based brain MRI approach in real world clinical settings, several major issues should be considered. Secondary changes due to illness duration and medication, clinical subtypes and heterogeneity, comorbidities, and cost-effectiveness restrict the generalization of the current machine learning findings. Sophisticated classification of clinical and diagnostic subtypes is needed. Additionally, as the approach is inevitably limited by sample size, multi-site participation and data-sharing are needed in the future. Copyright © 2017 Elsevier Inc. All rights reserved.

Specialized Laboratory Information Systems.

PubMed

Dangott, Bryan

2015-06-01

Some laboratories or laboratory sections have unique needs that traditional anatomic and clinical pathology systems may not address. A specialized laboratory information system (LIS), which is designed to perform a limited number of functions, may perform well in areas where a traditional LIS falls short. Opportunities for specialized LISs continue to evolve with the introduction of new testing methodologies. These systems may take many forms, including stand-alone architecture, a module integrated with an existing LIS, a separate vendor-supplied module, and customized software. This article addresses the concepts underlying specialized LISs, their characteristics, and in what settings they are found. Copyright © 2015 Elsevier Inc. All rights reserved.

Specialized Laboratory Information Systems.

PubMed

Dangott, Bryan

2016-03-01

Some laboratories or laboratory sections have unique needs that traditional anatomic and clinical pathology systems may not address. A specialized laboratory information system (LIS), which is designed to perform a limited number of functions, may perform well in areas where a traditional LIS falls short. Opportunities for specialized LISs continue to evolve with the introduction of new testing methodologies. These systems may take many forms, including stand-alone architecture, a module integrated with an existing LIS, a separate vendor-supplied module, and customized software. This article addresses the concepts underlying specialized LISs, their characteristics, and in what settings they are found. Copyright © 2016 Elsevier Inc. All rights reserved.

The clinical effects of Kinesio® Tex taping: A systematic review.

PubMed

Morris, D; Jones, D; Ryan, H; Ryan, C G

2013-05-01

Kinesio(®) Tex tape (KTT) is used in a variety of clinical settings. The purpose of this study was to investigate the effect of KTT from randomized controlled trials (RCTs) in the management of clinical conditions. A systematic literature search of CINAHL; MEDLINE; OVID; AMED; SCIENCE DIRECT; PEDRO; www.internurse.com; SPORT DISCUS; BRITISH NURSING INDEX; www.kinesiotaping.co.uk; www.kinesiotaping.com; COCHRANE CENTRAL REGISTER OF CLINICAL TRIALS; and PROQUEST was performed up to April 2012. The risk of bias and quality of evidence grading was performed using the Cochrane collaboration methodology. Eight RCTs met the full inclusion/exclusion criteria. Six of these included patients with musculoskeletal conditions; one included patients with breast-cancer-related lymphedema; and one included stroke patients with muscle spasticity. Six studies included a sham or usual care tape/bandage group. There was limited to moderate evidence that KTT is no more clinically effective than sham or usual care tape/bandage. There was limited evidence from one moderate quality RCT that KTT in conjunction with physiotherapy was clinically beneficial for plantar fasciitis related pain in the short term; however, there are serious questions around the internal validity of this RCT. There currently exists insufficient evidence to support the use of KTT over other modalities in clinical practice.

Factors Influencing the Clinical Stratification of Suitability to Drive after Stroke: A Qualitative Study.

PubMed

Stapleton, Tadhg; Connolly, Deirdre; O'Neill, Desmond

2015-01-01

While a clinical pre-selection screening process for a stroke patient's suitability for driving has been acknowledged, little is known about the factors or processes influencing this screening typically conducted by clinicians practicing at a generalist level. This study explored this clinical stratification process through the use of semi-structured interviews with senior occupational therapists (n = 17) and stroke physicians (n = 7) using qualitative description methodology. The findings revealed a trichotomy stratification of stroke patients for driving in the clinical setting; those who are fit to drive, unfit to drive, and a "maybe" group who need more detailed assessment and observation. Factors that had a major influence on this clinical-based stratification of driving suitability were client's levels of awareness, insight, and impulsivity. A period of prolonged contact with the client was preferential to guide the stratification decision in order for clinicians to build a comprehensive picture of the person. A mix of assessment approaches including standardized assessment but with increased emphasis on naturalistic observation of functional performance underpinned the clinical stratification process. This study uncovers some of the factors and processes influencing the early clinical-based stratification of driving suitability after stroke, and highlights the contribution of the generalist practitioner in the assessment of fitness to drive continuum.

Evidence-based practice in speech-language pathology curricula: a scoping study.

PubMed

Togher, Leanne; Yiannoukas, Corina; Lincoln, Michelle; Power, Emma; Munro, Natalie; Mccabe, Patricia; Ghosh, Pratiti; Worrall, Linda; Ward, Elizabeth; Ferguson, Alison; Harrison, Elisabeth; Douglas, Jacinta

2011-12-01

This scoping study investigated how evidence-based practice (EBP) principles are taught in Australian speech-language pathology (SLP) teaching and learning contexts. It explored how Australian SLP university programs: (1) facilitate student learning about the principles of EBP in academic and clinical settings, and (2) self-evaluate their curricula in relation to EBP. The research involved two surveys. Survey 1 respondents were 131 academic staff, program coordinators, and on-campus and off-campus clinical educators. This survey gathered information about EBP teaching and learning in SLP programs as well as future EBP curriculum plans. Survey 2 investigated how clinical educators incorporated EBP into the way they taught clinical decision-making to students. Surveys responses from 85 clinical educators were analysed using descriptive and non-parametric statistics and thematic grouping of open-ended qualitative responses. Both surveys revealed strengths and gaps in integrating EBP into Australian SLP curricula. Perceived strengths were that respondents were positive about EBP, most had EBP training and access to EBP resources. The perceived gaps included the academic staff's perceptions of students' understanding and application of EBP, respondents' understanding of research methodologies, communication and collaboration between academic staff and clinical educators, and a lack of explicit discussion by clinical educators and students of EBP in relation to clients.

Decision-problem state analysis methodology

NASA Technical Reports Server (NTRS)

Dieterly, D. L.

1980-01-01

A methodology for analyzing a decision-problem state is presented. The methodology is based on the analysis of an incident in terms of the set of decision-problem conditions encountered. By decomposing the events that preceded an unwanted outcome, such as an accident, into the set of decision-problem conditions that were resolved, a more comprehensive understanding is possible. All human-error accidents are not caused by faulty decision-problem resolutions, but it appears to be one of the major areas of accidents cited in the literature. A three-phase methodology is presented which accommodates a wide spectrum of events. It allows for a systems content analysis of the available data to establish: (1) the resolutions made, (2) alternatives not considered, (3) resolutions missed, and (4) possible conditions not considered. The product is a map of the decision-problem conditions that were encountered as well as a projected, assumed set of conditions that should have been considered. The application of this methodology introduces a systematic approach to decomposing the events that transpired prior to the accident. The initial emphasis is on decision and problem resolution. The technique allows for a standardized method of accident into a scenario which may used for review or the development of a training simulation.

Setting priorities for space research: An experiment in methodology

NASA Technical Reports Server (NTRS)

1995-01-01

In 1989, the Space Studies Board created the Task Group on Priorities in Space Research to determine whether scientists should take a role in recommending priorities for long-term space research initiatives and, if so, to analyze the priority-setting problem in this context and develop a method by which such priorities could be established. After answering the first question in the affirmative in a previous report, the task group set out to accomplish the second task. The basic assumption in developing a priority-setting process is that a reasoned and structured approach for ordering competing initiatives will yield better results than other ways of proceeding. The task group proceeded from the principle that the central criterion for evaluating a research initiative must be its scientific merit -- the value of the initiative to the proposing discipline and to science generally. The group developed a two-stage methodology for priority setting and constructed a procedure and format to support the methodology. The first of two instruments developed was a standard format for structuring proposals for space research initiatives. The second instrument was a formal, semiquantitative appraisal procedure for evaluating competing proposals. This report makes available complete templates for the methodology, including the advocacy statement and evaluation forms, as well as an 11-step schema for a priority-setting process. From the beginning of its work, the task group was mindful that the issue of priority setting increasingly pervades all of federally supported science and that its work would have implications extending beyond space research. Thus, although the present report makes no recommendations for action by NASA or other government agencies, it provides the results of the task group's work for the use of others who may study priority-setting procedures or take up the challenge of implementing them in the future.

A synthesis of convenience survey and other data to estimate undiagnosed HIV infection among men who have sex with men in England and Wales.

PubMed

Walker, Kate; Seaman, Shaun R; De Angelis, Daniela; Presanis, Anne M; Dodds, Julie P; Johnson, Anne M; Mercey, Danielle; Gill, O Noel; Copas, Andrew J

2011-10-01

Hard-to-reach population subgroups are typically investigated using convenience sampling, which may give biased estimates. Combining information from such surveys, a probability survey and clinic surveillance, can potentially minimize the bias. We developed a methodology to estimate the prevalence of undiagnosed HIV infection among men who have sex with men (MSM) in England and Wales aged 16-44 years in 2003, making fuller use of the available data than earlier work. We performed a synthesis of three data sources: genitourinary medicine clinic surveillance (11 380 tests), a venue-based convenience survey including anonymous HIV testing (3702 MSM) and a general population sexual behaviour survey (134 MSM). A logistic regression model to predict undiagnosed infection was fitted to the convenience survey data and then applied to the MSMs in the population survey to estimate the prevalence of undiagnosed infection in the general MSM population. This estimate was corrected for selection biases in the convenience survey using clinic surveillance data. A sensitivity analysis addressed uncertainty in our assumptions. The estimated prevalence of undiagnosed HIV in MSM was 2.4% [95% confidence interval (95% CI 1.7-3.0%)], and between 1.6% (95% CI 1.1-2.0%) and 3.3% (95% CI 2.4-4.1%) depending on assumptions; corresponding to 5500 (3390-7180), 3610 (2180-4740) and 7570 (4790-9840) men, and undiagnosed fractions of 33, 24 and 40%, respectively. Our estimates are consistent with earlier work that did not make full use of data sources. Reconciling data from multiple sources, including probability-, clinic- and venue-based convenience samples can reduce bias in estimates. This methodology could be applied in other settings to take full advantage of multiple imperfect data sources.

Quality of reporting of outcomes in phase III studies of pulmonary tuberculosis: a systematic review.

PubMed

Bonnett, Laura Jayne; Ken-Dror, Gie; Davies, Geraint Rhys

2018-02-21

Despite more than 60 years of clinical trials, tuberculosis (TB) still causes a high global burden of mortality and morbidity. Treatment currently requires multiple drugs in combination, taken over a prolonged period. New drugs are needed to shorten treatment duration, prevent resistance and reduce adverse events. However, to improve on current methodology in drug development, a more complete understanding of the existing clinical evidence base is required. A systematic review was undertaken to summarise outcomes reported in phase III trials of patients with newly diagnosed pulmonary TB. A systematic search of databases (PubMed, MEDLINE, EMBASE, CENTRAL and LILACs) was conducted on 30 November 2017 to retrieve relevant peer-reviewed articles. Reference lists of included studies were also searched. This systematic review considered all reported outcomes. Of 248 included studies, 229 considered "on-treatment" outcomes whilst 148 reported "off-treatment" outcomes. There was wide variation and ambiguity in the definition of reported outcomes, including their relationship to treatment and in the time points evaluated. Additional challenges were observed regarding the analysis approach taken (per protocol versus intention to treat) and the varying durations of "intensive" and "continuation" phases of treatment. Bacteriological outcomes were most frequently reported but radiological and clinical data were often included as an implicit or explicit component of the overall definition of outcome. Terminology used to define long-term outcomes in phase III trials is inconsistent, reflecting evolving differences in protocols and practices. For successful future cumulative meta-analysis, the findings of this review suggest that greater availability of individual patient data and the development of a core outcome set would be desirable. In the meantime, we propose a simple and logical approach which should facilitate combination of key evidence and inform improvements in the methodology of TB drug development and clinical trials.

Current evidence of peripheral vestibular symptoms secondary to otitis media.

PubMed

Monsanto, Rafael da Costa; Kasemodel, Ana Luiza Papi; Tomaz, Andreza; Paparella, Michael M; Penido, Norma de Oliveira

2018-05-06

The association between otitis media and vestibular symptoms has been hypothesized in the past. Thus, in this study, we aimed to critically analyze (based in a systematic review of the literature) whether patients who have otitis media are at greater risk of developing vestibular impairment or not. We performed a systematic review of the literature and identified potentially relevant articles reporting vestibular symptoms and results of vestibular function tests in patients with otitis media through searches of the PubMED, Web of Science, Scopus, and Google Scholar databases. The quality of the final set of records was assessed using the "Newcaste-Ottawa Scale". Of the 2334 records searched, 43 met our inclusion and exclusion criteria, and those included 2250 patients. The records comprised 20 longitudinal studies, 21 cross-sectional studies, and 2 case reports. Regarding the type of otitis media studied, 25 examined vestibular impairment in otitis media with effusion, 6 acute otitis media, and 12 chronic otitis media. Results of anamnesis, clinical exams, and several vestibular function tests are reported and critically discussed. Most studies evaluating the association between otitis media and vestibular symptoms have potential methodological flaws. Clinical evidence suggests that patients with otitis media have increased chances for having vestibular symptoms, delayed acquisition of developmental milestones, and abnormalities in several vestibular function tests as compared with controls. Future studies with rigorous methodology aiming to assess the clinical significance (and prognostic factors) of the association between otitis media and vestibular impairment are warranted. Key message Several studies demonstrated long-term sequelae secondary to otitis media. However, the evidence supporting those assumptions are based in low-quality evidence. Thus, better structured studies are warranted to better understand the clinical relevance of such association.

From Controlled Trial to Community Adoption: The Multisite Translational Community Trial

PubMed Central

Murimi, Mary; Gonzalez, Anjelica; Njike, Valentine; Green, Lawrence W.

2011-01-01

Methods for translating the findings of controlled trials, such as the Diabetes Prevention Program, into real-world community application have not been clearly defined. A standardized research methodology for making and evaluating such a transition is needed. We introduce the multisite translational community trial (mTCT) as the research analog to the multisite randomized controlled trial. The mTCT is adapted to incorporate the principles and practices of community-based participatory research and the increased relevance and generalizability gained from diverse community settings. The mTCT is a tool designed to bridge the gap between what a clinical trial demonstrates can work in principle and what is needed to make it workable and effective in real-world settings. Its utility could be put to the test, in particular with practice-based research networks such as the Prevention Research Centers. PMID:21680935

"Mobile Nurse" platform for ubiquitous medicine.

PubMed

Struzik, Z R; Yoshiuchi, K; Sone, M; Ishikawa, T; Kikuchi, H; Kumano, H; Watsuji, T; Natelson, B H; Yamamoto, Y

2007-01-01

We introduce "Mobile Nurse" (MN) - an emerging platform for the practice of ubiquitous medicine. By implementing in a dynamic setting of daily life the patient care traditionally provided by the clinical nurses on duty, MN aims at integral data collection and shortening the response time to the patient. MN is also capable of intelligent interaction with the patient and is able to learn from the patient's behavior and disease sign evaluation for improved personalized treatment. In this paper, we outline the most essential concepts around the hardware, software and methodological designs of MN. We provide an example of the implementation, and elaborate on the possible future impact on medical practice and biomedical science research. The main innovation of MN, setting it apart from current tele-medicine systems, is the ability to integrate the patient's signs and symptoms on site, providing medical professionals with powerful tools to elucidate disease mechanisms, to make proper diagnoses and to prescribe treatment.

Understanding the Knowledge Gap Experienced by U.S. Safety Net Patients in Teleretinal Screening.

PubMed

George, Sheba M; Hayes, Erin Moran; Fish, Allison; Daskivich, Lauren Patty; Ogunyemi, Omolola I

2016-01-01

Safety-net patients' socioeconomic barriers interact with limited digital and health literacies to produce a "knowledge gap" that impacts the delivery of healthcare via telehealth technologies. Six focus groups (2 African- American and 4 Latino) were conducted with patients who received teleretinal screening in a U.S. urban safety-net setting. Focus groups were analyzed using a modified grounded theory methodology. Findings indicate that patients' knowledge gap is primarily produced at three points during the delivery of care: (1) exacerbation of patients' pre-existing personal barriers in the clinical setting; (2) encounters with technology during screening; and (3) lack of follow up after the visit. This knowledge gap produces confusion, potentially limiting patients' perceptions of care and their ability to manage their own care. It may be ameliorated through delivery of patient education focused on both disease pathology and specific role of telehealth technologies in disease management.

Preceptorship in the intergenerational context: an integrative review of the literature.

PubMed

Earle, Vicki; Myrick, Florence; Yonge, Olive

2011-01-01

Preceptorship is a teaching/learning method used in many undergraduate nursing programs whereby learners are individually assigned to expert practitioners in the clinical setting. The current reality in today's workplace setting encompasses four generations (Veterans, Baby Boomers, Generation X, and Millennials) working together and often these generations do not share the same work ethic or expectations. Given this generational diversity, increased knowledge and awareness of the intergenerational context of the preceptorship experience is both an important and timely topic for nursing education. The purpose of this paper is to discuss an integrative review of the literature using the methodology of Whittemore and Knafl (2005). The computerized databases of CINAHL, PubMed, ProQuest Education, ERIC, and EMBASE were used to generate relevant literature. The sample consisted of 98 articles; 18 being research and 80 theoretical. Given the large sample size, the authors focus on summarizing the research literature in this paper. This review calls attention to the need for further research into generational diversity and its influence on the preceptorship experience. It also highlights the limited research that currently exists on the topic of the intergenerational nursing workforce. Implications for nursing education and clinical practice are also discussed. 2010 Elsevier Ltd. All rights reserved.

Investigating interactional competencies in Parkinson's disease: the potential benefits of a conversation analytic approach.

PubMed

Griffiths, Sarah; Barnes, Rebecca; Britten, Nicky; Wilkinson, Ray

2011-01-01

Around 70% of people who develop Parkinson's disease (PD) experience speech and voice changes. Clinicians often find that when asked about their primary communication concerns, PD clients will talk about the difficulties they have 'getting into' conversations. This is an important area for clients and it has implications for quality of life and clinical management. To review the extant literature on PD and communication impairments in order to reveal key topic areas, the range of methodologies applied, and any gaps in knowledge relating to PD and social interaction and how these might be usefully addressed. A systematic search of a number of key databases and available grey literatures regarding PD and communication impairment was conducted (including motor speech changes, intelligibility, cognitive/language changes) to obtain a sense of key areas and methodologies applied. Research applying conversation analysis in the field of communication disability was also reviewed to illustrate the value of this methodology in uncovering common interactional difficulties, and in revealing the use of strategic collaborative competencies in naturally occurring conversation. In addition, available speech and language therapy assessment and intervention approaches to PD were examined with a view to their effectiveness in promoting individualized intervention planning and advice-giving for everyday interaction. A great deal has been written about the deficits underpinning communication changes in PD and the impact of communication disability on the self and others as measured in a clinical setting. Less is known about what happens for this client group in everyday conversations outside of the clinic. Current speech and language therapy assessments and interventions focus on the individual and are largely impairment based or focused on compensatory speaker-oriented techniques. A conversation analysis approach would complement basic research on what actually happens in everyday conversation for people with PD and their co-participants. The potential benefits of a conversation analysis approach to communication disability in PD include enabling a shift in clinical focus from individual impairment onto strategic collaborative competencies. This would have implications for client-centred intervention planning and the development of new and complementary clinical resources addressing participation. The impact would be new and improved support for those living with the condition as well as their families and carers. © 2011 Royal College of Speech & Language Therapists.

Comprehensive Psychopathological Assessment Based on the Association for Methodology and Documentation in Psychiatry (AMDP) System: Development, Methodological Foundation, Application in Clinical Routine, and Research.

PubMed

Stieglitz, Rolf-Dieter; Haug, Achim; Fähndrich, Erdmann; Rösler, Michael; Trabert, Wolfgang

2017-01-01

The documentation of psychopathology is core to the clinical practice of the psychiatrist and clinical psychologist. However, both in initial as well as further training and specialization in their fields, this particular aspect of their work receives scanty attention only. Yet, for the past 50 years, the Association for Methodology and Documentation in Psychiatry (AMDP) System has been in existence and available as a tool to serve precisely the purpose of offering a systematic introduction to the terminology and documentation of psychopathology. The motivation for its development was based on the need for an assessment procedure for the reliable documentation of the effectiveness of newly developed psychopharmacological substances. Subsequently, the AMDP-System began to be applied in the context of investigations into a number of methodological issues in psychiatry (e.g., the frequency and specificity of particular symptoms, the comparison of rating scales). The System then became increasingly important also in clinical practice and, today, represents the most used instrument for the documentation of psychopathology in the German-speaking countries of Europe. This paper intends to offer an overview of the AMDP-System, its origins, design, and functionality. After an initial account of the history and development of the AMDP-System, the discussion will in turn focus on the System's underlying methodological principles, the transfer of clinical skills and competencies in its practical application, and its use in research and clinical practice. Finally, potential future areas of development in relation to the AMDP-System are explored.

Comprehensive Psychopathological Assessment Based on the Association for Methodology and Documentation in Psychiatry (AMDP) System: Development, Methodological Foundation, Application in Clinical Routine, and Research

PubMed Central

Stieglitz, Rolf-Dieter; Haug, Achim; Fähndrich, Erdmann; Rösler, Michael; Trabert, Wolfgang

2017-01-01

The documentation of psychopathology is core to the clinical practice of the psychiatrist and clinical psychologist. However, both in initial as well as further training and specialization in their fields, this particular aspect of their work receives scanty attention only. Yet, for the past 50 years, the Association for Methodology and Documentation in Psychiatry (AMDP) System has been in existence and available as a tool to serve precisely the purpose of offering a systematic introduction to the terminology and documentation of psychopathology. The motivation for its development was based on the need for an assessment procedure for the reliable documentation of the effectiveness of newly developed psychopharmacological substances. Subsequently, the AMDP-System began to be applied in the context of investigations into a number of methodological issues in psychiatry (e.g., the frequency and specificity of particular symptoms, the comparison of rating scales). The System then became increasingly important also in clinical practice and, today, represents the most used instrument for the documentation of psychopathology in the German-speaking countries of Europe. This paper intends to offer an overview of the AMDP-System, its origins, design, and functionality. After an initial account of the history and development of the AMDP-System, the discussion will in turn focus on the System’s underlying methodological principles, the transfer of clinical skills and competencies in its practical application, and its use in research and clinical practice. Finally, potential future areas of development in relation to the AMDP-System are explored. PMID:28439242

Empirical and pragmatic adequacy of grounded theory: Advancing nurse empowerment theory for nurses' practice.

PubMed

Udod, Sonia A; Racine, Louise

2017-12-01

To draw on the findings of a grounded theory study aimed at exploring how power is exercised in nurse-manager relationships in the hospital setting, this paper examines the empirical and pragmatic adequacy of grounded theory as a methodology to advance the concept of empowerment in the area of nursing leadership and management. The evidence on staff nurse empowerment has highlighted the magnitude of individual and organisational outcomes, but has not fully explicated the micro-level processes underlying how power is exercised, shared or created within the nurse-manager relationship. Although grounded theory is a widely adopted nursing research methodology, it remains less used in nursing leadership because of the dominance of quantitative approaches to research. Grounded theory methodology provides the empirical and pragmatic relevance to inform nursing practice and policy. Grounded theory is a relevant qualitative approach to use in leadership research as it provides a fine and detailed analysis of the process underlying complexity and bureaucracy. Discursive paper. A critical examination of the empirical and pragmatic relevance of grounded theory by (Corbin & Strauss, , ) as a method for analysing and solving problems in nurses' practice is provided. This paper provides evidence to support the empirical and pragmatic adequacy of grounded theory methodology. Although the application of the ontological, epistemological and methodological assumptions of grounded theory is challenging, this methodology is useful to address real-life problems in nursing practice by developing theoretical explanations of nurse empowerment, or lack thereof, in the workplace. Grounded theory represents a relevant methodology to inform nursing leadership research. Grounded theory is anchored in the reality of practice. The strength of grounded theory is to provide results that can be readily applied to clinical practice and policy as they arise from problems that affect practice and that are meaningful to nurses. © 2017 John Wiley & Sons Ltd.

FDAAA legislation is working, but methodological flaws undermine the reliability of clinical trials: a cross-sectional study.

PubMed

Marin Dos Santos, Douglas H; Atallah, Álvaro N

2015-01-01

The relationship between clinical research and the pharmaceutical industry has placed clinical trials in jeopardy. According to the medical literature, more than 70% of clinical trials are industry-funded. Many of these trials remain unpublished or have methodological flaws that distort their results. In 2007, it was signed into law the Food and Drug Administration Amendments Act (FDAAA), aiming to provide publicly access to a broad range of biomedical information to be made available on the platform ClinicalTrials (available at https://www.clinicaltrials.gov). We accessed ClinicalTrials.gov and evaluated the compliance of researchers and sponsors with the FDAAA. Our sample comprised 243 protocols of clinical trials of biological monoclonal antibodies (mAb) adalimumab, bevacizumab, infliximab, rituximab, and trastuzumab. We demonstrate that the new legislation has positively affected transparency patterns in clinical research, through a significant increase in publication and online reporting rates after the enactment of the law. Poorly designed trials, however, remain a challenge to be overcome, due to a high prevalence of methodological flaws. These flaws affect the quality of clinical information available, breaching ethical duties of sponsors and researchers, as well as the human right to health.

FDAAA legislation is working, but methodological flaws undermine the reliability of clinical trials: a cross-sectional study

PubMed Central

Atallah, Álvaro N.

2015-01-01

The relationship between clinical research and the pharmaceutical industry has placed clinical trials in jeopardy. According to the medical literature, more than 70% of clinical trials are industry-funded. Many of these trials remain unpublished or have methodological flaws that distort their results. In 2007, it was signed into law the Food and Drug Administration Amendments Act (FDAAA), aiming to provide publicly access to a broad range of biomedical information to be made available on the platform ClinicalTrials (available at https://www.clinicaltrials.gov). We accessed ClinicalTrials.gov and evaluated the compliance of researchers and sponsors with the FDAAA. Our sample comprised 243 protocols of clinical trials of biological monoclonal antibodies (mAb) adalimumab, bevacizumab, infliximab, rituximab, and trastuzumab. We demonstrate that the new legislation has positively affected transparency patterns in clinical research, through a significant increase in publication and online reporting rates after the enactment of the law. Poorly designed trials, however, remain a challenge to be overcome, due to a high prevalence of methodological flaws. These flaws affect the quality of clinical information available, breaching ethical duties of sponsors and researchers, as well as the human right to health. PMID:26131374

Steps towards the international regulatory acceptance of non-animal methodology in safety assessment.

PubMed

Sewell, Fiona; Doe, John; Gellatly, Nichola; Ragan, Ian; Burden, Natalie

2017-10-01

The current animal-based paradigm for safety assessment must change. In September 2016, the UK National Centre for Replacement, Refinement and Reduction of Animals in Research (NC3Rs) brought together scientists from regulatory authorities, academia and industry to review progress in bringing new methodology into regulatory use, and to identify ways to expedite progress. Progress has been slow. Science is advancing to make this possible but changes are necessary. The new paradigm should allow new methodology to be adopted once it is developed rather than being based on a fixed set of studies. Regulatory authorities can help by developing Performance-Based Standards. The most pressing need is in repeat dose toxicology, although setting standards will be more complex than in areas such as sensitization. Performance standards should be aimed directly at human safety, not at reproducing the results of animal studies. Regulatory authorities can also aid progress towards the acceptance of non-animal based methodology by promoting "safe-haven" trials where traditional and new methodology data can be submitted in parallel to build up experience in the new methods. Industry can play its part in the acceptance of new methodology, by contributing to the setting of performance standards and by actively contributing to "safe-haven" trials. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

CONTRIBUTORS TO FATIGUE IN PATIENTS RECEIVING MECHANICAL VENTILATORY SUPPORT: A DESCRIPTIVE CORRELATIONAL STUDY

PubMed Central

Chlan, Linda L.; Savik, Kay

2015-01-01

Objectives To describe levels of fatigue and explore clinical factors that might contribute to fatigue in critically ill patients receiving mechanical ventilation. Research Methodology/Design Descriptive, correlational design. Sample was a sub-set of patients enrolled in a randomized clinical trial testing patient-directed music for anxiety self-management. Clinical factors included age, gender, length of ICU stay, length of ventilatory support, illness severity (APACHE III), and sedative exposure (sedation intensity and frequency). Descriptive statistics and mixed models were used to address the study objectives. Setting Medical and surgical intensive care units in the Midwestern U.S.A. Main Outcome Measures Fatigue was measured daily via a 100-mm Visual Analog Scale, up to 25 days. Results A sample of 80 patients (50% female) receiving ventilatory support for a median 7.9 days (range 1-46) with a mean age of 61.2 years (SD 14.8) provided daily fatigue ratings. ICU admission APACHE III was 61.5 (SD 19.8). Baseline mean fatigue ratings were 60.7 (SD 27.9), with fluctuations over time indicating a general trend upward. Mixed models analysis implicated illness severity (β(se(β)) = .27(.12)) and sedation frequency (β(se(β)) = 1.2(.52)) as significant contributors to fatigue ratings. Conclusion Illness severity and more frequent sedative administration were related to higher fatigue ratings in these mechanically ventilated patients. PMID:26005034

Evaluation metrics for biostatistical and epidemiological collaborations.

PubMed

Rubio, Doris McGartland; Del Junco, Deborah J; Bhore, Rafia; Lindsell, Christopher J; Oster, Robert A; Wittkowski, Knut M; Welty, Leah J; Li, Yi-Ju; Demets, Dave

2011-10-15

Increasing demands for evidence-based medicine and for the translation of biomedical research into individual and public health benefit have been accompanied by the proliferation of special units that offer expertise in biostatistics, epidemiology, and research design (BERD) within academic health centers. Objective metrics that can be used to evaluate, track, and improve the performance of these BERD units are critical to their successful establishment and sustainable future. To develop a set of reliable but versatile metrics that can be adapted easily to different environments and evolving needs, we consulted with members of BERD units from the consortium of academic health centers funded by the Clinical and Translational Science Award Program of the National Institutes of Health. Through a systematic process of consensus building and document drafting, we formulated metrics that covered the three identified domains of BERD practices: the development and maintenance of collaborations with clinical and translational science investigators, the application of BERD-related methods to clinical and translational research, and the discovery of novel BERD-related methodologies. In this article, we describe the set of metrics and advocate their use for evaluating BERD practices. The routine application, comparison of findings across diverse BERD units, and ongoing refinement of the metrics will identify trends, facilitate meaningful changes, and ultimately enhance the contribution of BERD activities to biomedical research. Copyright © 2011 John Wiley & Sons, Ltd.

The "Performance of Rotavirus and Oral Polio Vaccines in Developing Countries" (PROVIDE) study: description of methods of an interventional study designed to explore complex biologic problems.

PubMed

Kirkpatrick, Beth D; Colgate, E Ross; Mychaleckyj, Josyf C; Haque, Rashidul; Dickson, Dorothy M; Carmolli, Marya P; Nayak, Uma; Taniuchi, Mami; Naylor, Caitlin; Qadri, Firdausi; Ma, Jennie Z; Alam, Masud; Walsh, Mary Claire; Diehl, Sean A; Petri, William A

2015-04-01

Oral vaccines appear less effective in children in the developing world. Proposed biologic reasons include concurrent enteric infections, malnutrition, breast milk interference, and environmental enteropathy (EE). Rigorous study design and careful data management are essential to begin to understand this complex problem while assuring research subject safety. Herein, we describe the methodology and lessons learned in the PROVIDE study (Dhaka, Bangladesh). A randomized clinical trial platform evaluated the efficacy of delayed-dose oral rotavirus vaccine as well as the benefit of an injectable polio vaccine replacing one dose of oral polio vaccine. This rigorous infrastructure supported the additional examination of hypotheses of vaccine underperformance. Primary and secondary efficacy and immunogenicity measures for rotavirus and polio vaccines were measured, as well as the impact of EE and additional exploratory variables. Methods for the enrollment and 2-year follow-up of a 700 child birth cohort are described, including core laboratory, safety, regulatory, and data management practices. Intense efforts to standardize clinical, laboratory, and data management procedures in a developing world setting provide clinical trials rigor to all outcomes. Although this study infrastructure requires extensive time and effort, it allows optimized safety and confidence in the validity of data gathered in complex, developing country settings. © The American Society of Tropical Medicine and Hygiene.

The integration of behavioral health interventions in children's health care: services, science, and suggestions.

PubMed

Kolko, David J; Perrin, Ellen

2014-01-01

Because the integration of mental or behavioral health services in pediatric primary care is a national priority, a description and evaluation of the interventions applied in the healthcare setting is warranted. This article examines several intervention research studies based on alternative models for delivering behavioral health care in conjunction with comprehensive pediatric care. This review describes the diverse methods applied to different clinical problems, such as brief mental health skills, clinical guidelines, and evidence-based practices, and the empirical outcomes of this research literature. Next, several key treatment considerations are discussed to maximize the efficiency and effectiveness of these interventions. Some practical suggestions for overcoming key service barriers are provided to enhance the capacity of the practice to deliver behavioral health care. There is moderate empirical support for the feasibility, acceptability, and clinical utility of these interventions for treating internalizing and externalizing behavior problems. Practical strategies to extend this work and address methodological limitations are provided that draw upon recent frameworks designed to simplify the treatment enterprise (e.g., common elements). Pediatric primary care has become an important venue for providing mental health services to children and adolescents due, in part, to its many desirable features (e.g., no stigma, local setting, familiar providers). Further adaptation of existing delivery models may promote the delivery of effective integrated interventions with primary care providers as partners designed to address mental health problems in pediatric healthcare.