Development of a core outcome set for medication review in older patients with multimorbidity and polypharmacy: a study protocol.

PubMed

Beuscart, Jean-Baptiste; Dalleur, Olivia; Boland, Benoit; Thevelin, Stefanie; Knol, Wilma; Cullinan, Shane; Schneider, Claudio; O'Mahony, Denis; Rodondi, Nicolas; Spinewine, Anne

2017-01-01

Medication review has been advocated to address the challenge of polypharmacy in older patients, yet there is no consensus on how best to evaluate its efficacy. Heterogeneity of outcomes reported in clinical trials can hinder the comparison of clinical trial findings in systematic reviews. Moreover, the outcomes that matter most to older patients might be under-reported or disregarded altogether. A core outcome set can address this issue as it defines a minimum set of outcomes that should be reported in all clinical trials in any particular field of research. As part of the European Commission-funded project, called OPtimising thERapy to prevent Avoidable hospital admissions in the Multimorbid elderly, this paper describes the methods used to develop a core outcome set for clinical trials of medication review in older patients with multimorbidity. The study was designed in several steps. First, a systematic review established which outcomes were measured in published and ongoing clinical trials of medication review in older patients. Second, we undertook semistructured interviews with older patients and carers aimed at identifying additional relevant outcomes. Then, a multilanguage European Delphi survey adapted to older patients was designed. The international Delphi survey was conducted with older patients, health care professionals, researchers, and clinical experts in geriatric pharmacotherapy to validate outcomes to be included in the core outcome set. Consensus meetings were conducted to validate the results. We present the method for developing a core outcome set for medication review in older patients with multimorbidity. This study protocol could be used as a basis to develop core outcome sets in other fields of geriatric research.

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.

Validated Outcomes in the Grafting of Autologous Fat to the Breast: The VOGUE Study. Development of a Core Outcome Set for Research and Audit.

PubMed

Agha, Riaz A; Pidgeon, Thomas E; Borrelli, Mimi R; Dowlut, Naeem; Orkar, Ter-Er K; Ahmed, Maziyah; Pujji, Ojas; Orgill, Dennis P

2018-05-01

Autologous fat grafting is an important part of the reconstructive surgeon's toolbox when treating women affected by breast cancer and subsequent tumor extirpation. The debate over safety and efficacy of autologous fat grafting continues within the literature. However, work performed by the authors' group has shown significant heterogeneity in outcome reporting. Core outcome sets have been shown to reduce heterogeneity in outcome reporting. The authors' goal was to develop a core outcome set for autologous fat grafting in breast reconstruction. The authors published their protocol a priori. A Delphi consensus exercise among key stakeholders was conducted using a list of outcomes generated from their previous work. These outcomes were divided into six domains: oncologic, clinical, aesthetic and functional, patient-reported, process, and radiologic. In the first round, 55 of 78 participants (71 percent) completed the Delphi consensus exercise. Consensus was reached on nine of the 13 outcomes. The clarity of the results and lack of additional suggested outcomes deemed further rounds to be unnecessary. The VOGUE Study has led to the development of a much-needed core outcome set in the active research front and clinical area of autologous fat grafting. The authors hope that clinicians will use this core outcome set to audit their practice, and that researchers will implement these outcomes in their study design and reporting of autologous fat grafting outcomes. The authors encourage journals and surgical societies to endorse and encourage use of this core outcome set to help refine the scientific quality of the debate, the discourse, and the literature. Therapeutic, V.

A Preliminary Core Domain Set for Clinical Trials of Shoulder Disorders: A Report from the OMERACT 2016 Shoulder Core Outcome Set Special Interest Group.

PubMed

Buchbinder, Rachelle; Page, Matthew J; Huang, Hsiaomin; Verhagen, Arianne P; Beaton, Dorcas; Kopkow, Christian; Lenza, Mario; Jain, Nitin B; Richards, Bethan; Richards, Pamela; Voshaar, Marieke; van der Windt, Danielle; Gagnier, Joel J

2017-12-01

The Outcome Measures in Rheumatology (OMERACT) Shoulder Core Outcome Set Special Interest Group (SIG) was established to develop a core outcome set (COS) for clinical trials of shoulder disorders. In preparation for OMERACT 2016, we systematically examined all outcome domains and measurement instruments reported in 409 randomized trials of interventions for shoulder disorders published between 1954 and 2015. Informed by these data, we conducted an international Delphi consensus study including shoulder trial experts, clinicians, and patients to identify key domains that should be included in a shoulder disorder COS. Findings were discussed at a stakeholder premeeting of OMERACT. At OMERACT 2016, we sought consensus on a preliminary core domain set and input into next steps. There were 13 and 15 participants at the premeeting and the OMERACT 2016 SIG meeting, respectively (9 attended both meetings). Consensus was reached on a preliminary core domain set consisting of an inner core of 4 domains: pain, physical function/activity, global perceived effect, and adverse events including death. A middle core consisted of 3 domains: emotional well-being, sleep, and participation (recreation and work). An outer core of research required to inform the final COS was also formulated. Our next steps are to (1) analyze whether participation (recreation and work) should be in the inner core, (2) conduct a third Delphi round to finalize definitions and wording of domains and reach final endorsement for the domains, and (3) determine which instruments fulfill the OMERACT criteria for measuring each domain.

Using the International Classification of Functioning, Disability, and Health to identify outcome domains for a core outcome set for aphasia: a comparison of stakeholder perspectives.

PubMed

Wallace, Sarah J; Worrall, Linda; Rose, Tanya; Le Dorze, Guylaine

2017-11-12

This study synthesised the findings of three separate consensus processes exploring the perspectives of key stakeholder groups about important aphasia treatment outcomes. This process was conducted to generate recommendations for outcome domains to be included in a core outcome set for aphasia treatment trials. International Classification of Functioning, Disability, and Health codes were examined to identify where the groups of: (1) people with aphasia, (2) family members, (3) aphasia researchers, and (4) aphasia clinicians/managers, demonstrated congruence in their perspectives regarding important treatment outcomes. Codes were contextualized using qualitative data. Congruence across three or more stakeholder groups was evident for ICF chapters: Mental functions; Communication; and Services, systems, and policies. Quality of life was explicitly identified by clinicians/managers and researchers, while people with aphasia and their families identified outcomes known to be determinants of quality of life. Core aphasia outcomes include: language, emotional wellbeing, communication, patient-reported satisfaction with treatment and impact of treatment, and quality of life. International Classification of Functioning, Disability, and Health coding can be used to compare stakeholder perspectives and identify domains for core outcome sets. Pairing coding with qualitative data may ensure important nuances of meaning are retained. Implications for rehabilitation The outcomes measured in treatment research should be relevant to stakeholders and support health care decision making. Core outcome sets (agreed, minimum set of outcomes, and outcome measures) are increasingly being used to ensure the relevancy and consistency of the outcomes measured in treatment studies. Important aphasia treatment outcomes span all components of the International Classification of Functioning, Disability, and Health. Stakeholders demonstrated congruence in the identification of important outcomes which related Mental functions; Communication; Services, systems, and policies; and Quality of life. A core outcome set for aphasia treatment research should include measures relating to: language, emotional wellbeing, communication, patient-reported satisfaction with treatment and impact of treatment, and quality of life. Coding using the International Classification of Functioning, Disability, and Health, presents a novel methodology for the comparison of stakeholder perspectives to inform recommendations for outcome constructs to be included in a core outcome set. Coding can be paired with qualitative data to ensure nuances of meaning are retained.

Developing core economic outcome sets for asthma studies: a protocol for a systematic review.

PubMed

Hounsome, Natalia; Fitzsimmons, Deborah; Phillips, Ceri; Patel, Anita

2017-08-11

Core outcome sets are standardised lists of outcomes, which should be measured and reported in all clinical studies of a specific condition. This study aims to develop core outcome sets for economic evaluations in asthma studies. Economic outcomes include items such as costs, resource use or quality-adjusted life years. The starting point in developing core outcome sets will be conducting a systematic literature review to establish a preliminary list of reporting items to be considered for inclusion in the core outcome set. We will conduct literature searches of peer-reviewed studies published from January 1990 to January 2017. These will include any comparative or observational studies (including economic models) and systematic reviews reporting economic outcomes. All identified economic outcomes will be tabulated together with the major study characteristics, such as population, study design, the nature and intensity of the intervention, mode of data collection and instrument(s) used to derive an outcome. We will undertake a 'realist synthesis review' to analyse the identified economic outcomes. The outcomes will be summarised in the context of evaluation perspectives, types of economic evaluation and methodological approaches. Parallel to undertaking a systematic review, we will conduct semistructured interviews with stakeholders (including people with personal experience of asthma, health professionals, researchers and decision makers) in order to explore additional outcomes which have not been considered, or used, in published studies. The list of outcomes generated from the systematic review and interviews with stakeholders will form the basis of a Delphi survey to refine the identified outcomes into a core outcome set. The review will not involve access to individual-level data. Findings from our systematic review will be communicated to a broad range of stakeholders including clinical guideline developers, research funders, trial registries, ethics committees and other regulators. © 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.

Updating the OMERACT filter: core areas as a basis for defining core outcome sets.

PubMed

Kirwan, John R; Boers, Maarten; Hewlett, Sarah; Beaton, Dorcas; Bingham, Clifton O; Choy, Ernest; Conaghan, Philip G; D'Agostino, Maria-Antonietta; Dougados, Maxime; Furst, Daniel E; Guillemin, Francis; Gossec, Laure; van der Heijde, Désirée M; Kloppenburg, Margreet; Kvien, Tore K; Landewé, Robert B M; Mackie, Sarah L; Matteson, Eric L; Mease, Philip J; Merkel, Peter A; Ostergaard, Mikkel; Saketkoo, Lesley Ann; Simon, Lee; Singh, Jasvinder A; Strand, Vibeke; Tugwell, Peter

2014-05-01

The Outcome Measures in Rheumatology (OMERACT) Filter provides guidelines for the development and validation of outcome measures for use in clinical research. The "Truth" section of the OMERACT Filter presupposes an explicit framework for identifying the relevant core outcomes that are universal to all studies of the effects of intervention effects. There is no published outline for instrument choice or development that is aimed at measuring outcome, was derived from broad consensus over its underlying philosophy, or includes a structured and documented critique. Therefore, a new proposal for defining core areas of measurement ("Filter 2.0 Core Areas of Measurement") was presented at OMERACT 11 to explore areas of consensus and to consider whether already endorsed core outcome sets fit into this newly proposed framework. Discussion groups critically reviewed the extent to which case studies of current OMERACT Working Groups complied with or negated the proposed framework, whether these observations had a more general application, and what issues remained to be resolved. Although there was broad acceptance of the framework in general, several important areas of construction, presentation, and clarity of the framework were questioned. The discussion groups and subsequent feedback highlighted 20 such issues. These issues will require resolution to reach consensus on accepting the proposed Filter 2.0 framework of Core Areas as the basis for the selection of Core Outcome Domains and hence appropriate Core Outcome Sets for clinical trials.

Core outcome sets for research and clinical practice.

PubMed

Chiarotto, Alessandro; Ostelo, Raymond W; Turk, Dennis C; Buchbinder, Rachelle; Boers, Maarten

This masterclass introduces the topic of core outcome sets, describing rationale and methods for developing them, and providing some examples that are relevant for clinical research and practice. A core outcome set is a minimum consensus-based set of outcomes that should be measured and reported in all clinical trials for a specific health condition and/or intervention. Issues surrounding outcome assessment, such as selective reporting and inconsistency across studies, can be addressed by the development of a core set. As suggested by key initiatives in this field (i.e. OMERACT and COMET), the development requires achieving consensus on: (1) core outcome domains and (2) core outcome measurement instruments. Different methods can be used to reach consensus, including: literature systematic reviews to inform the process, qualitative research with clinicians and patients, group discussions (e.g. nominal group technique), and structured surveys (e.g. Delphi technique). Various stakeholders should be involved in the process, with particular attention to patients. Several COSs have been developed for musculoskeletal conditions including a longstanding one for low back pain, IMMPACT recommendations on outcomes for chronic pain, and OMERACT COSs for hip, knee and hand osteoarthritis. There is a lack of COSs for neurological, geriatric, cardio-respiratory and pediatric conditions, therefore, future research could determine the value of developing COSs for these conditions. Copyright © 2017 Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia. Publicado por Elsevier Editora Ltda. All rights reserved.

Developing core outcome sets for clinical trials: issues to consider

PubMed Central

2012-01-01

The selection of appropriate outcomes or domains is crucial when designing clinical trials in order to compare directly the effects of different interventions in ways that minimize bias. If the findings are to influence policy and practice then the chosen outcomes need to be relevant and important to key stakeholders including patients and the public, health care professionals and others making decisions about health care. There is a growing recognition that insufficient attention has been paid to the outcomes measured in clinical trials. These issues could be addressed through the development and use of an agreed standardized collection of outcomes, known as a core outcome set, which should be measured and reported, as a minimum, in all trials for a specific clinical area. Accumulating work in this area has identified the need for general guidance on the development of core outcome sets. Key issues to consider in the development of a core outcome set include its scope, the stakeholder groups to involve, choice of consensus method and the achievement of a consensus. PMID:22867278

Development of a core outcome set for research and audit studies in reconstructive breast surgery.

PubMed

Potter, S; Holcombe, C; Ward, J A; Blazeby, J M

2015-10-01

Appropriate outcome selection is essential if research is to guide decision-making and inform policy. Systematic reviews of the clinical, cosmetic and patient-reported outcomes of reconstructive breast surgery, however, have demonstrated marked heterogeneity, and results from individual studies cannot be compared or combined. Use of a core outcome set may improve the situation. The BRAVO study developed a core outcome set for reconstructive breast surgery. A long list of outcomes identified from systematic reviews and stakeholder interviews was used to inform a questionnaire survey. Key stakeholders defined as individuals involved in decision-making for reconstructive breast surgery, including patients, breast and plastic surgeons, specialist nurses and psychologists, were sampled purposively and sent the questionnaire (round 1). This asked them to rate the importance of each outcome on a 9-point Likert scale from 1 (not important) to 9 (extremely important). The proportion of respondents rating each item as very important (score 7-9) was calculated. This was fed back to participants in a second questionnaire (round 2). Respondents were asked to reprioritize outcomes based on the feedback received. Items considered very important after round 2 were discussed at consensus meetings, where the core outcome set was agreed. A total of 148 items were combined into 34 domains within six categories. Some 303 participants (51·4 per cent) (215 (49·5 per cent) of 434 patients; 88 (56·4 per cent) of 156 professionals) completed and returned the round 1 questionnaire, and 259 (85·5 per cent) reprioritized outcomes in round 2. Fifteen items were excluded based on questionnaire scores and 19 were carried forward to the consensus meetings, where a core outcome set containing 11 key outcomes was agreed. The BRAVO study has used robust consensus methodology to develop a core outcome set for reconstructive breast surgery. Widespread adoption by the reconstructive community will improve the quality of outcome assessment in effectiveness studies. Future work will evaluate how these key outcomes should best be measured. © 2015 The Authors. BJS published by John Wiley & Sons Ltd on behalf of BJS Society Ltd.

Defining Outcome Measures for Psoriasis: The IDEOM Report from the GRAPPA 2016 Annual Meeting.

PubMed

Callis Duffin, Kristina; Gottlieb, Alice B; Merola, Joseph F; Latella, John; Garg, Amit; Armstrong, April W

2017-05-01

The International Dermatology Outcome Measures (IDEOM) psoriasis working group was established to develop core domains and measurements sets for psoriasis clinical trials and ultimately clinical practice. At the 2016 annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis, the IDEOM psoriasis group presented an overview of its progress toward developing this psoriasis core domain set. First, it summarized the February 2016 meeting of all involved with the IDEOM, highlighting patient and payer perspectives on outcome measures. Second, the group presented an overview of the consensus process for developing the core domain set for psoriasis, including previous literature reviews, nominal group exercises, and meeting discussions. Future plans include the development of working groups to review candidate measures for at least 2 of the domains, including primary pathophysiologic manifestations and patient-reported outcomes, and Delphi surveys to gain consensus on the final psoriasis core domain set.

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.

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/.

Recommendations for a first Core Outcome Measurement set for complex regional PAin syndrome Clinical sTudies (COMPACT)

PubMed Central

Grieve, Sharon; Perez, Roberto SGM; Birklein, Frank; Brunner, Florian; Bruehl, Stephen; Harden R, Norman; Packham, Tara; Gobeil, Francois; Haigh, Richard; Holly, Janet; Terkelsen, Astrid; Davies, Lindsay; Lewis, Jennifer; Thomassen, Ilona; Connett, Robyn; Worth, Tina; Vatine, Jean-Jacques; McCabe, Candida S

2017-01-01

Complex Regional Pain Syndrome (CRPS) is a persistent pain condition that remains incompletely understood and challenging to treat. Historically, a wide range of different outcome measures have been used to capture the multidimensional nature of CRPS. This has been a significant limiting factor in the advancement of our understanding of the mechanisms and management of CRPS. In 2013, an international consortium of patients, clinicians, researchers and industry representatives was established, to develop and agree on a minimum core set of standardised outcome measures for use in future CRPS clinical research, including but not limited to clinical trials within adult populations The development of a core measurement set was informed through workshops and supplementary work, using an iterative consensus process. ‘What is the clinical presentation and course of CRPS, and what factors influence it?’ was agreed as the most pertinent research question that our standardised set of patient-reported outcome measures should be selected to answer. The domains encompassing the key concepts necessary to answer the research question were agreed as: pain, disease severity, participation and physical function, emotional and psychological function, self efficacy, catastrophizing and patient's global impression of change. The final core measurement set included the optimum generic or condition-specific patient-reported questionnaire outcome measures, which captured the essence of each domain, and one clinician reported outcome measure to capture the degree of severity of CRPS. The next step is to test the feasibility and acceptability of collecting outcome measure data using the core measurement set in the CRPS population internationally. PMID:28178071

Three nested randomized controlled trials of peer-only or multiple stakeholder group feedback within Delphi surveys during core outcome and information set development.

PubMed

Brookes, Sara T; Macefield, Rhiannon C; Williamson, Paula R; McNair, Angus G; Potter, Shelley; Blencowe, Natalie S; Strong, Sean; Blazeby, Jane M

2016-08-17

Methods for developing a core outcome or information set require involvement of key stakeholders to prioritise many items and achieve agreement as to the core set. The Delphi technique requires participants to rate the importance of items in sequential questionnaires (or rounds) with feedback provided in each subsequent round such that participants are able to consider the views of others. This study examines the impact of receiving feedback from different stakeholder groups, on the subsequent rating of items and the level of agreement between stakeholders. Randomized controlled trials were nested within the development of three core sets each including a Delphi process with two rounds of questionnaires, completed by patients and health professionals. Participants rated items from 1 (not essential) to 9 (absolutely essential). For round 2, participants were randomized to receive feedback from their peer stakeholder group only (peer) or both stakeholder groups separately (multiple). Decisions as to which items to retain following each round were determined by pre-specified criteria. Whilst type of feedback did not impact on the percentage of items for which a participant subsequently changed their rating, or the magnitude of change, it did impact on items retained at the end of round 2. Each core set contained discordant items retained by one feedback group but not the other (3-22 % discordant items). Consensus between patients and professionals in items to retain was greater amongst those receiving multiple group feedback in each core set (65-82 % agreement for peer-only feedback versus 74-94 % for multiple feedback). In addition, differences in round 2 scores were smaller between stakeholder groups receiving multiple feedback than between those receiving peer group feedback only. Variability in item scores across stakeholders was reduced following any feedback but this reduction was consistently greater amongst the multiple feedback group. In the development of a core outcome or information set, providing feedback within Delphi questionnaires from all stakeholder groups separately may influence the final core set and improve consensus between the groups. Further work is needed to better understand how participants rate and re-rate items within a Delphi process. The three randomized controlled trials reported here were each nested within the development of a core information or outcome set to investigate processes in core outcome and information set development. Outcomes were not health-related and therefore trial registration was not applicable.

Proposal for a candidate core-set of fitness and strength tests for patients with childhood or adult idiopathic inflammatory myopathies

PubMed Central

van der Stap, Djamilla K.D.; Rider, Lisa G.; Alexanderson, Helene; Huber, Adam M.; Gualano, Bruno; Gordon, Patrick; van der Net, Janjaap; Mathiesen, Pernille; Johnson, Liam G.; Ernste, Floranne C.; Feldman, Brian M.; Houghton, Kristin M.; Singh-Grewal, Davinder; Kutzbach, Abraham Garcia; Munters, Li Alemo; Takken, Tim

2015-01-01

OBJECTIVES Currently there are no evidence-based recommendations regarding which fitness and strength tests to use for patients with childhood or adult idiopathic inflammatory myopathies (IIM). This hinders clinicians and researchers in choosing the appropriate fitness- or muscle strength-related outcome measures for these patients. Through a Delphi survey, we aimed to identify a candidate core-set of fitness and strength tests for children and adults with IIM. METHODS Fifteen experts participated in a Delphi survey that consisted of five stages to achieve a consensus. Using an extensive search of published literature and through the expertise of the experts, a candidate core-set based on expert opinion and clinimetric properties was developed. Members of the International Myositis Assessment and Clinical Studies Group (IMACS) were invited to review this candidate core-set during the final stage, which led to a final candidate core-set. RESULTS A core-set of fitness- and strength-related outcome measures was identified for children and adults with IIM. For both children and adults, different tests were identified and selected for maximal aerobic fitness, submaximal aerobic fitness, anaerobic fitness, muscle strength tests and muscle function tests. CONCLUSIONS The core-set of fitness and strength-related outcome measures provided by this expert consensus process will assist practitioners and researchers in deciding which tests to use in IIM patients. This will improve the uniformity of fitness and strength tests across studies, thereby facilitating the comparison of study results and therapeutic exercise program outcomes among patients with IIM. PMID:26568594

A core outcome set for evaluating self-management interventions in people with comorbid diabetes and severe mental illness: study protocol for a modified Delphi study and systematic review.

PubMed

Taylor, Johanna; Böhnke, Jan R; Wright, Judy; Kellar, Ian; Alderson, Sarah L; Hughes, Tom; Holt, Richard I G; Siddiqi, Najma

2017-02-14

People with diabetes and comorbid severe mental illness (SMI) form a growing population at risk of increased mortality and morbidity compared to those with diabetes or SMI alone. There is increasing interest in interventions that target diabetes in SMI in order to help to improve physical health and reduce the associated health inequalities. However, there is a lack of consensus about which outcomes are important for this comorbid population, with trials differing in their focus on physical and mental health. A core outcome set, which includes outcomes across both conditions that are relevant to patients and other key stakeholders, is needed. This study protocol describes methods to develop a core outcome set for use in effectiveness trials of self-management interventions for adults with comorbid type-2 diabetes and SMI. We will use a modified Delphi method to identify, rank, and agree core outcomes. This will comprise a two-round online survey and multistakeholder workshops involving patients and carers, health and social care professionals, health care commissioners, and other experts (e.g. academic researchers and third sector organisations). We will also select appropriate measurement tools for each outcome in the proposed core set and identify gaps in measures, where these exist. The proposed core outcome set will provide clear guidance about what outcomes should be measured, as a minimum, in trials of interventions for people with coexisting type-2 diabetes and SMI, and improve future synthesis of trial evidence in this area. We will also explore the challenges of using online Delphi methods for this hard-to-reach population, and examine differences in opinion about which outcomes matter to diverse stakeholder groups. COMET registration: http://www.comet-initiative.org/studies/details/911 . Registered on 1 July 2016.

Including patients in core outcome set development: issues to consider based on three workshops with around 100 international delegates.

PubMed

Young, Bridget; Bagley, Heather

2016-01-01

This commentary article describes three interactive workshops that explored how patients can contribute to decisions about what outcomes are measured in clinical trials across the world. Outcomes like quality of life, side-effects and pain are used in trials to measure whether a treatment is effective. Here, we outline how research groups are increasingly coming together to develop 'core outcomes sets' for particular conditions. Core outcome sets are lists of agreed outcomes. Their use will help in identifying which treatments are effective by enabling people to compare the findings of different clinical trials in the same condition. Currently, it is often very difficult to make these comparisons because different studies often measure different outcomes. Delegates attending the workshops included patients, clinicians and researchers. They discussed ways of making core outcome set development more meaningful and accessible for patients, and ensuring that they have a genuine say in the development process. This article summarises these discussions and concludes by identifying three distinctive challenges in securing patient input to core outcome set development: the process and objectives can seem far removed from the immediate concerns of patients, difficulties can arise in securing patient input on an international scale, and difficulties can also arise in bringing multiple stakeholder groups together to achieve consensus. While patient participation, involvement and engagement in core outcome set development can draw on lessons from other research areas, these distinctive challenges point to the need for distinctive solutions to enable meaningful patient input to core outcome set development. Background This article describes three workshops that explored how patients can contribute to decisions about what outcomes are measured in clinical trials. People need evidence about what treatments are best for particular health conditions. The strongest evidence comes from systematic reviews comparing outcomes across different studies of treatments for a particular condition. However, it is often difficult to do these comparisons because the different studies-even though they have all investigated the same condition-often measure different outcomes. To tackle this problem, research teams are increasingly coming together to develop core outcome sets (COS) for particular conditions or treatments. The goal is that across the world, all the research teams working on the same condition or treatment will then use the COS in their research. Main body We report on three interactive workshops that explored how patients and the public can contribute to decision making about what outcomes should be included in a COS. About 100 international delegates, including researchers, clinicians and patients, attended the workshops. The workshops were held in the United Kingdom, Italy and Canada as part of the COMET (Core Outcome Measures in Effectiveness Trials) Initiative annual meetings. Patients who had some experience as research advisors, collaborators, partners or co-ordinators facilitated the workshops together with a researcher. Notes made during each workshop informed the preparation of this article. Workshop discussion focussed on ways of making core outcome set development more meaningful and accessible for patients. Delegates wanted patients to have a genuine say, alongside other stakeholders, in what outcomes are included in COS. Delegates felt that key to ensuring this is recognising that patient participation in COS development alone is not enough, and that patients will also need to be involved in the design of COS development studies. Conclusion We conclude by pointing to some distinctive challenges in including patients in COS development. While the COS development community can draw on the lessons learnt from other research areas about patient participation, involvement and engagement, the distinctive challenges that arise in COS development point to the need for some distinctive solutions too.

Creation of a core outcome set for clinical trials of people with shoulder pain: a study protocol.

PubMed

Gagnier, Joel J; Page, Matthew J; Huang, Hsiaomin; Verhagen, Arianne P; Buchbinder, Rachelle

2017-07-20

The selection of appropriate outcomes or domains is crucial when designing clinical trials, to appreciate the effects of different interventions, pool results, and make valid comparisons between trials. If the findings are to influence policy and practice, then the chosen outcomes need to be relevant and important to key stakeholders, including patients and the public, healthcare professionals and others making decisions about health care. There is a growing recognition that insufficient attention has been paid to the outcomes measured in clinical trials. Recent reviews of the measurement properties of patient-reported outcome measures for shoulder disorders revealed a large selection of diverse measures, many with questionable validity, reliability, and responsiveness. These issues could be addressed through the development and use of an agreed standardized collection of outcomes, known as a core outcome set (COS), which should be measured and reported in all trials of shoulder disorders. The purpose of the present project is to develop and disseminate a COS for clinical trials in shoulder disorders. The methods for the COS development will include 3 phases: (1) a comprehensive review of the core domains used in shoulder disorder trials; (2) an international Delphi study involving relevant stakeholders (patients, clinicians, scientists) to define which domains should be core; and (3) an international focus group informed by the evidence identified in phases 1 and 2, to determine which measurement instruments best measure the core domains and identification of any evidence gaps that require further empiric evidence. The aim of the current proposal is to convene several meetings of international experts and patients to develop a COS for clinical trials of shoulder disorders and to develop an implementation strategy to ensure rapid uptake of the core set of outcomes in clinical trials. There would be an expectation that the core set of outcomes would always be collected and reported, but it would not preclude use of additional outcomes in a particular trial.

Development of a core outcome set for studies involving patients undergoing major lower limb amputation for peripheral arterial disease: study protocol for a systematic review and identification of a core outcome set using a Delphi survey.

PubMed

Ambler, Graeme K; Bosanquet, David C; Brookes-Howell, Lucy; Thomas-Jones, Emma; Waldron, Cherry-Ann; Edwards, Adrian G K; Twine, Christopher P

2017-12-28

The development of a standardised reporting set is important to ensure that research is directed towards the most important outcomes and that data is comparable. To ensure validity, the set must be agreed by a consensus of stakeholders including patients, healthcare professionals and lay representatives. There is currently no agreed core outcome set for patients undergoing major lower limb amputation for peripheral arterial disease (PAD) for either short- or medium-term research outcomes. By developing these sets we aim to rationalise future trial outcomes, facilitate meta-analysis and improve the quality and applicability of amputation research. We will undertake a comprehensive systematic review of studies of patients undergoing major lower limb amputation for PAD. Data regarding all primary and secondary outcomes reported in relevant studies will be extracted and summarised as outcome domains. We will then undertake focus groups with key stakeholders (patients, carers, health and social care workers) to collect qualitative data to identify the main short- and medium-term research outcomes for patients undergoing major lower limb amputation. Results of the systematic review and focus groups will be combined to create a comprehensive list of potential key outcomes. Stakeholders (patients, researchers and health and social care workers) will then be polled to determine which of the outcomes are considered to be important in a general context using a three-phase Delphi process. After preliminary analysis, results will be presented at a face-to-face meeting of key stakeholders for discussion and voting on the final set of core outcomes. This project is being run in parallel with a feasibility trial assessing perineural catheters in patients undergoing lower limb amputation (the PLACEMENT trial). Full ethical approval has been granted for the study (Wales REC 3 reference number 16/WA/0353). Core outcome sets will be developed for short- and medium-term outcomes of research involving patients undergoing major lower limb amputation for PAD. This will help with the design of future trials and facilitate meta-analyses of trial data. PROSPERO: CRD42017059329 . Registered on 30 March 2017. 975 . Registered on 5 April 2017.

A core outcome set for localised prostate cancer effectiveness trials: protocol for a systematic review of the literature and stakeholder involvement through interviews and a Delphi survey.

PubMed

MacLennan, Steven; Bekema, Hendrika J; Williamson, Paula R; Campbell, Marion K; Stewart, Fiona; MacLennan, Sara J; N'Dow, James M O; Lam, Thomas B L

2015-03-04

Prostate cancer is a growing health problem worldwide. The management of localised prostate cancer is controversial. It is unclear which of several surgical, radiotherapeutic, ablative, and surveillance treatments is the most effective. All have cost, process and recovery, and morbidity implications which add to treatment decision-making complexity for patients and healthcare professionals. Evidence from randomised controlled trials (RCTs) is not optimal because of uncertainty as to what constitutes important outcomes. Another issue hampering evidence synthesis is heterogeneity of outcome definition, measurement, and reporting. This project aims to determine which outcomes are the most important to patients and healthcare professionals, and use these findings to recommend a standardised core outcome set for comparative effectiveness trials of treatments for localised prostate cancer, to optimise decision-making. The range of potentially important outcomes and measures will be identified through systematic reviews of the literature and semi-structured interviews with patients. A consultation exercise involving representatives from two key stakeholder groups (patients and healthcare professionals) will ratify the list of outcomes to be entered into a three round Delphi study. The Delphi process will refine and prioritise the list of identified outcomes. A methodological substudy (nested RCT design) will also be undertaken. Participants will be randomised after round one of the Delphi study to one of three feedback groups, based on different feedback strategies, in order to explore the potential impact of feedback strategies on participant responses. This may assist the design of a future core outcome set and Delphi studies. Following the Delphi study, a final consensus meeting attended by representatives from both stakeholder groups will determine the final recommended core outcome set. This study will inform clinical practice and future trials of interventions of localised prostate cancer by standardising a core outcome set which should be considered in comparative effectiveness studies for localised prostate cancer.

Reaching clinically relevant outcome measures for new pharmacotherapy and immunotherapy of atopic eczema.

PubMed

Chalmers, Joanne; Deckert, Stefanie; Schmitt, Jochen

2015-06-01

This article describes the core outcome set (COS) for atopic eczema trials. COS describe a minimum set of outcomes to be assessed in a defined situation. COS are required to overcome the current situation of different trials using different endpoints with unclear/insufficient measurement properties resulting in incomparable trials. The global multi-stakeholder Harmonising Outcomes Measures for Eczema initiative developed the Harmonising Outcomes Measures for Eczema roadmap as a generic framework for COS development. Following the establishment of a panel representing all stakeholders, a core set of outcome domains need to be selected based on systematic reviews and consensus methods. Outcome measurement instruments to assess these core domains need to be valid, reliable, and feasible. There is broad global consensus that clinical signs, quality of life, symptoms, and long-term control of flares form the COS for atopic eczema trials. The Eczema Area and Severity Index is recommended to assess clinical signs in atopic eczema trials. Systematic reviews to identify adequate outcome measurement instruments for the other core outcome domains are underway. Clinical signs should be assessed in all atopic eczema trials by at least the Eczema Area and Severity Index. Quality of life, symptoms, and flares should also be assessed in all atopic eczema trials by a valid, reliable, and feasible instrument.

A comparison of participation outcome measures and the International Classification of Functioning, Disability and Health Core Sets for traumatic brain injury.

PubMed

Chung, Pearl; Yun, Sarah Jin; Khan, Fary

2014-02-01

To compare the contents of participation outcome measures in traumatic brain injury with the International Classification of Functioning, Disability and Health (ICF) Core Sets for traumatic brain injury. A systematic search with an independent review process selected relevant articles to identify outcome measures in participation in traumatic brain injury. Instruments used in two or more studies were linked to the ICF categories, which identified categories in participation for comparison with the ICF Core Sets for traumatic brain injury. Selected articles (n = 101) identified participation instruments used in two or more studies (n = 9): Community Integration Questionnaire, Craig Handicap Assessment and Reporting Technique, Mayo-Portland Adaptability Inventory-4 Participation Index, Sydney Psychosocial Reintegration Scale Version-2, Participation Assessment with Recombined Tool-Objective, Community Integration Measure, Participation Objective Participation Subjective, Community Integration Questionnaire-2, and Quality of Community Integration Questionnaire. Each instrument was linked to 4-35 unique second-level ICF categories, of which 39-100% related to participation. Instruments addressed 86-100% and 50-100% of the participation categories in the Comprehensive and Brief ICF Core Sets for traumatic brain injury, respectively. Participation measures in traumatic brain injury were compared with the ICF Core Sets for traumatic brain injury. The ICF Core Sets for traumatic brain injury could contribute to the development and selection of participation measures.

Development of a core outcome set for orthodontic trials using a mixed-methods approach: protocol for a multicentre study.

PubMed

Tsichlaki, Aliki; O'Brien, Kevin; Johal, Ama; Marshman, Zoe; Benson, Philip; Colonio Salazar, Fiorella B; Fleming, Padhraig S

2017-08-04

Orthodontic treatment is commonly undertaken in young people, with over 40% of children in the UK needing treatment and currently one third having treatment, at a cost to the National Health Service in England and Wales of £273 million each year. Most current research about orthodontic care does not consider what patients truly feel about, or want, from treatment, and a diverse range of outcomes is being used with little consistency between studies. This study aims to address these problems, using established methodology to develop a core outcome set for use in future clinical trials of orthodontic interventions in children and young people. This is a mixed-methods study incorporating four distinct stages. The first stage will include a scoping review of the scientific literature to identify primary and secondary outcome measures that have been used in previous orthodontic clinical trials. The second stage will involve qualitative interviews and focus groups with orthodontic patients aged 10 to 16 years to determine what outcomes are important to them. The outcomes elicited from these two stages will inform the third stage of the study in which a long-list of outcomes will be ranked in terms of importance using electronic Delphi surveys involving clinicians and patients. The final stage of the study will involve face-to-face consensus meetings with all stakeholders to discuss and agree on the outcome measures that should be included in the final core outcome set. This research will help to inform patients, parents, clinicians and commissioners about outcomes that are important to young people undergoing orthodontic treatment. Adoption of the core outcome set in future clinical trials of orthodontic treatment will make it easier for results to be compared, contrasted and combined. This should translate into improved decision-making by all stakeholders involved. The project has been registered on the Core Outcome Measures in Effectiveness Trials ( COMET ) website, January 2016.

Lower Anogenital Tract Disease Therapy Outcomes, COMET, and CROWN: Call for Research Submissions.

PubMed

Andrews, Jeffrey

2015-10-01

There is a problem of inconsistent and inappropriate outcome selection for research studies. We can improve the relevance of research results for women and for their physicians and clinicians by encouraging researchers to critically evaluate outcome measures, and use valid, appropriate, standardized measures. To this purpose, and to facilitate synthesis of the evidence, outcomes reported by clinical studies should be standardized for different disease conditions through the development of core outcome sets (COS). There is an international effort for reaching consensus on outcome measures and establishing COS that represent agreed-upon standardized collections of outcome measures that will be reported in all studies within a clinical area. Across clinical specialties, the Core Outcome Measures in Effectiveness Trials (COMET) initiative launched in 2010. In 2014, the editors of women's health journals answered the challenge of COMET and formed the Core Outcomes in Women's Health initiative. The Journal of Lower Genital Tract Diseases is a participating member of the Core Outcomes in Women's Health consortium. There is broad inconsistency in outcome measures and reporting in the field of lower anogenital tract diseases. No core outcome sets currently exist. Suggested target conditions in anogenital disease are vulvar dermatoses, cervical intraepithelial neoplasia, and vulvodynia. Investigators are encouraged to conduct secondary systematic research to determine previously reported primary outcome measures and suggest domains for COS. Core Outcomes in Women's health initiative and COMET encourage the formation of consensus panels of stakeholders (researchers, health care providers, patients, and others) to recommend outcome domains and COS and then publish their report.

COS-STAR: a reporting guideline for studies developing core outcome sets (protocol).

PubMed

Kirkham, Jamie J; Gorst, Sarah; Altman, Douglas G; Blazeby, Jane; Clarke, Mike; Devane, Declan; Gargon, Elizabeth; Williamson, Paula R

2015-08-22

Core outcome sets can increase the efficiency and value of research and, as a result, there are an increasing number of studies looking to develop core outcome sets (COS). However, the credibility of a COS depends on both the use of sound methodology in its development and clear and transparent reporting of the processes adopted. To date there is no reporting guideline for reporting COS studies. The aim of this programme of research is to develop a reporting guideline for studies developing COS and to highlight some of the important methodological considerations in the process. The study will include a reporting guideline item generation stage which will then be used in a Delphi study. The Delphi study is anticipated to include two rounds. The first round will ask stakeholders to score the items listed and to add any new items they think are relevant. In the second round of the process, participants will be shown the distribution of scores for all stakeholder groups separately and asked to re-score. A final consensus meeting will be held with an expert panel and stakeholder representatives to review the guideline item list. Following the consensus meeting, a reporting guideline will be drafted and review and testing will be undertaken until the guideline is finalised. The final outcome will be the COS-STAR (Core Outcome Set-STAndards for Reporting) guideline for studies developing COS and a supporting explanatory document. To assess the credibility and usefulness of a COS, readers of a COS development report need complete, clear and transparent information on its methodology and proposed core set of outcomes. The COS-STAR guideline will potentially benefit all stakeholders in COS development: COS developers, COS users, e.g. trialists and systematic reviewers, journal editors, policy-makers and patient groups.

Standardised outcomes in nephrology - Haemodialysis (SONG-HD): study protocol for establishing a core outcome set in haemodialysis.

PubMed

Tong, Allison; Manns, Braden; Hemmelgarn, Brenda; Wheeler, David C; Tugwell, Peter; Winkelmayer, Wolfgang C; van Biesen, Wim; Crowe, Sally; Kerr, Peter G; Polkinghorne, Kevan R; Howard, Kirsten; Pollock, Carol; Hawley, Carmel M; Johnson, David W; McDonald, Stephen P; Gallagher, Martin P; Urquhart-Secord, Rachel; Craig, Jonathan C

2015-08-19

Chronic kidney disease is a significant contributor to mortality and morbidity worldwide, and the number of people who require dialysis or transplantation continues to increase. People on dialysis are 15 times more likely to die than the general population. Dialysis is also costly, intrusive, and time-consuming and imposes an enormous burden on patients and their families. This escalating problem has spurred a proliferation of trials in dialysis, yet health and quality of life remain poor. The reasons for this are complex and varied but are attributable in part to problems in the design and reporting of studies, particularly outcome selection. Problems related to outcomes include use of unvalidated surrogates, outcomes of little or no relevance to patients, highly variable outcome selection limiting comparability across studies, and bias in reporting outcomes. The aim of the Standardised Outcomes in Nephrology-Haemodialysis (SONG-HD) study is to establish a core outcome set for haemodialysis trials, to improve the quality of reporting, and the relevance of trials conducted in people on haemodialysis. SONG-HD is a five-phase project that includes the following: a systematic review to identify outcomes that have been reported in haemodialysis systematic reviews and trials; nominal group technique with patients and caregivers to identify, rank, and describe reasons for their choices; qualitative stakeholder interviews with patients, caregivers, clinicians, researchers, and policy makers to elicit individual values and perspectives on outcomes for haemodialysis trials; a three-round Delphi survey with stakeholder groups to distil and generate a prioritised list of core outcomes; and a consensus workshop to establish a core outcome set for haemodialysis trials. Establishing a core outcome set to be consistently measured and reported in haemodialysis trials will improve the integrity, transparency, usability, and contribution of research relevant to patients requiring haemodialysis; ensure that outcomes of relevance to all stakeholders are consistently reported across trials; and mitigate against outcome reporting bias. Ultimately, patients will be more protected from potential harm, patients and clinicians will be better able to make informed decisions about treatment, and researchers and policy makers will be more able to maximise the value of research to the public.

Development of a core outcome set for disease modification trials in mild to moderate dementia: a systematic review, patient and public consultation and consensus recommendations.

PubMed Central

Webster, Lucy; Groskreutz, Derek; Grinbergs-Saull, Anna; Howard, Rob; O'Brien, John T; Mountain, Gail; Banerjee, Sube; Woods, Bob; Perneczky, Robert; Lafortune, Louise; Roberts, Charlotte; McCleery, Jenny; Pickett, James; Bunn, Frances; Challis, David; Charlesworth, Georgina; Featherstone, Katie; Fox, Chris; Goodman, Claire; Jones, Roy; Lamb, Sallie; Moniz-Cook, Esme; Schneider, Justine; Shepperd, Sasha; Surr, Claire; Thompson-Coon, Jo; Ballard, Clive; Brayne, Carol; Burke, Orlaith; Burns, Alistair; Clare, Linda; Garrard, Peter; Kehoe, Patrick; Passmore, Peter; Holmes, Clive; Maidment, Ian; Murtagh, Fliss; Robinson, Louise; Livingston, Gill

2017-01-01

BACKGROUND There is currently no disease-modifying treatment available to halt or delay the progression of the disease pathology in dementia. An agreed core set of the best-available and most appropriate outcomes for disease modification would facilitate the design of trials and ensure consistency across disease modification trials, as well as making results comparable and meta-analysable in future trials. OBJECTIVES To agree a set of core outcomes for disease modification trials for mild to moderate dementia with the UK dementia research community and patient and public involvement (PPI). DATA SOURCES We included disease modification trials with quantitative outcomes of efficacy from (1) references from related systematic reviews in workstream 1; (2) searches of the Cochrane Dementia and Cognitive Improvement Group study register, Cochrane Central Register of Controlled Trials, Cumulative Index to Nursing and Allied Health Literature, EMBASE, Latin American and Caribbean Health Sciences Literature and PsycINFO on 11 December 2015, and clinical trial registries [International Standard Randomised Controlled Trial Number (ISRCTN) and clinicaltrials.gov] on 22 and 29 January 2016; and (3) hand-searches of reference lists of relevant systematic reviews from database searches. REVIEW METHODS The project consisted of four workstreams. (1) We obtained related core outcome sets and work from co-applicants. (2) We systematically reviewed published and ongoing disease modification trials to identify the outcomes used in different domains. We extracted outcomes used in each trial, recording how many used each outcome and with how many participants. We divided outcomes into the domains measured and searched for validation data. (3) We consulted with PPI participants about recommended outcomes. (4) We presented all the synthesised information at a conference attended by the wider body of National Institute for Health Research (NIHR) dementia researchers to reach consensus on a core set of outcomes. RESULTS We included 149 papers from the 22,918 papers screened, referring to 125 individual trials. Eighty-one outcomes were used across trials, including 72 scales [31 cognitive, 12 activities of daily living (ADLs), 10 global, 16 neuropsychiatric and three quality of life] and nine biological techniques. We consulted with 18 people for PPI. The conference decided that only cognition and biological markers are core measures of disease modification. Cognition should be measured by the Mini Mental State Examination (MMSE) or the Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog), and brain changes through structural magnetic resonance imaging (MRI) in a subset of participants. All other domains are important but not core. We recommend using the Neuropsychiatric Inventory for neuropsychiatric symptoms: the Disability Assessment for Dementia for ADLs, the Dementia Quality of Life Measure for quality of life and the Clinical Dementia Rating scale to measure dementia globally. LIMITATIONS Most of the trials included participants with Alzheimer's disease, so recommendations may not apply to other types of dementia. We did not conduct economic analyses. The PPI consultation was limited to members of the Alzheimer's Society Research Network. CONCLUSIONS Cognitive outcomes and biological markers form the core outcome set for future disease modification trials, measured by the MMSE or ADAS-Cog, and structural MRI in a subset of participants. FUTURE WORK We envisage that the core set may be superseded in the future, particularly for other types of dementia. There is a need to develop an algorithm to compare scores on the MMSE and ADAS-Cog. STUDY REGISTRATION The project was registered with Core Outcome Measures in Effectiveness Trials [ www.comet-initiative.org/studies/details/819?result=true (accessed 7 April 2016)]. The systematic review protocol is registered as PROSPERO CRD42015027346. FUNDING The National Institute for Health Research Health Technology Assessment programme. PMID:28625273

Updating the Psoriatic Arthritis (PsA) Core Domain Set: A Report from the PsA Workshop at OMERACT 2016.

PubMed

Orbai, Ana-Maria; de Wit, Maarten; Mease, Philip J; Callis Duffin, Kristina; Elmamoun, Musaab; Tillett, William; Campbell, Willemina; FitzGerald, Oliver; Gladman, Dafna D; Goel, Niti; Gossec, Laure; Hoejgaard, Pil; Leung, Ying Ying; Lindsay, Chris; Strand, Vibeke; van der Heijde, Désirée M; Shea, Bev; Christensen, Robin; Coates, Laura; Eder, Lihi; McHugh, Neil; Kalyoncu, Umut; Steinkoenig, Ingrid; Ogdie, Alexis

2017-10-01

To include the patient perspective in accordance with the Outcome Measures in Rheumatology (OMERACT) Filter 2.0 in the updated Psoriatic Arthritis (PsA) Core Domain Set for randomized controlled trials (RCT) and longitudinal observational studies (LOS). At OMERACT 2016, research conducted to update the PsA Core Domain Set was presented and discussed in breakout groups. The updated PsA Core Domain Set was voted on and endorsed by OMERACT participants. We conducted a systematic literature review of domains measured in PsA RCT and LOS, and identified 24 domains. We conducted 24 focus groups with 130 patients from 7 countries representing 5 continents to identify patient domains. We achieved consensus through 2 rounds of separate surveys with 50 patients and 75 physicians, and a nominal group technique meeting with 12 patients and 12 physicians. We conducted a workshop and breakout groups at OMERACT 2016 in which findings were presented and discussed. The updated PsA Core Domain Set endorsed with 90% agreement by OMERACT 2016 participants included musculoskeletal disease activity, skin disease activity, fatigue, pain, patient's global assessment, physical function, health-related quality of life, and systemic inflammation, which were recommended for all RCT and LOS. These were important, but not required in all RCT and LOS: economic cost, emotional well-being, participation, and structural damage. Independence, sleep, stiffness, and treatment burden were on the research agenda. The updated PsA Core Domain Set was endorsed at OMERACT 2016. Next steps for the PsA working group include evaluation of PsA outcome measures and development of a PsA Core Outcome Measurement Set.

Development of core outcome sets for effectiveness trials of interventions to prevent and/or treat delirium (Del-COrS): study protocol.

PubMed

Rose, Louise; Agar, Meera; Burry, Lisa D; Campbell, Noll; Clarke, Mike; Lee, Jacques; Siddiqi, Najma; Page, Valerie J

2017-09-18

Delirium is a common, serious and potentially preventable condition with devastating impact on the quality of life prompting a proliferation of interventional trials. Core outcome sets aim to standardise outcome reporting by identifying outcomes perceived fundamental for measurement in trials of a specific interest area. Our aim is to develop international consensus on two core outcome sets for trials of interventions to prevent and/or treat delirium, irrespective of study population. We aim to identify additional core outcomes specific to the critically ill, acutely hospitalised patients, palliative care and older adults. We will conduct a systematic review of published and ongoing delirium trials (1980 onwards) and one-on-one interviews of patients who have experienced delirium and family members. These data will inform Delphi round 1 of a two-stage consensus process. In round 2, we will provide participants their own response, summarised group responses and those of patient/family participants for rescoring. We will randomise participants to receive feedback as proportion scoring the outcome as critical or as group mean responses. We will hold a consensus meeting using nominal group technique to finalise outcomes for inclusion. We will repeat the Delphi process and consensus meeting to select measures for each core outcome. We will recruit 240 Delphi participants giving us 80% power to detect a 1.0-1.5 point (9-point scale) difference by feedback method between rounds. We will analyse differences for subsequent scores, magnitude of opinion change, items retained and level of agreement. We are obtaining research ethics approvals according to local governance. Participation will be voluntary and data deidentified. Support from three international delirium organisations will be instrumental in dissemination and core outcome set uptake. We will disseminate through peer-reviewed open access publications and present at conferences selected to reach a wide range of knowledge users. © 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.

Social network analysis identified central outcomes for core outcome sets using systematic reviews of HIV/AIDS.

PubMed

Saldanha, Ian J; Li, Tianjing; Yang, Cui; Ugarte-Gil, Cesar; Rutherford, George W; Dickersin, Kay

2016-02-01

Methods to develop core outcome sets, the minimum outcomes that should be measured in research in a topic area, vary. We applied social network analysis methods to understand outcome co-occurrence patterns in human immunodeficiency virus (HIV)/AIDS systematic reviews and identify outcomes central to the network of outcomes in HIV/AIDS. We examined all Cochrane reviews of HIV/AIDS as of June 2013. We defined a tie as two outcomes (nodes) co-occurring in ≥2 reviews. To identify central outcomes, we used normalized node betweenness centrality (nNBC) (the extent to which connections between other outcomes in a network rely on that outcome as an intermediary). We conducted a subgroup analysis by HIV/AIDS intervention type (i.e., clinical management, biomedical prevention, behavioral prevention, and health services). The 140 included reviews examined 1,140 outcomes, 294 of which were unique. The most central outcome overall was all-cause mortality (nNBC = 23.9). The most central and most frequent outcomes differed overall and within subgroups. For example, "adverse events (specified)" was among the most central but not among the most frequent outcomes, overall. Social network analysis methods are a novel application to identify central outcomes, which provides additional information potentially useful for developing core outcome sets. Copyright © 2016 Elsevier Inc. All rights reserved.

Assessment of chronic post-surgical pain after knee replacement: development of a core outcome set.

PubMed

Wylde, V; MacKichan, F; Bruce, J; Gooberman-Hill, R

2015-05-01

Approximately 20% of patients experience chronic post-surgical pain (CPSP) after total knee replacement (TKR). There is scope to improve assessment of CPSP after TKR, and this study aimed to develop a core outcome set. Eighty patients and 43 clinicians were recruited into a three-round modified Delphi study. In Round 1, participants were presented with 56 pain features identified from a systematic review, structured interviews with patients and focus groups with clinicians. Participants assigned importance ratings, using a 1-9 scale, to individual pain features; those features rated as most important were retained in subsequent rounds. Consensus that a pain feature should be included in the core outcome set was defined as the feature having a rating of 7-9 by ≥70% of both panels (patients and clinicians) and 1-3 by ≤15% of both panels or rated as 7-9 by ≥90% of one panel. Round 1 was completed by 71 patients and 39 clinicians, and Round 3 by 62 patients and 33 clinicians. The final consensus was that 33 pain features were important. These were grouped into an 8-item core outcome set comprising: pain intensity, pain interference with daily living, pain and physical functioning, temporal aspects of pain, pain description, emotional aspects of pain, use of pain medication, and improvement and satisfaction with pain relief. This core outcome set serves to guide assessment of CPSP after TKR. Consistency in assessment can promote standardized reporting and facilitate comparability between studies that address a common but understudied type of CPSP. © 2014 The Authors. European Journal of Pain published by John Wiley & Sons Ltd on behalf of European Pain Federation - EFIC®.

Development of a Draft Core Set of Domains for Measuring Shared Decision Making in Osteoarthritis: An OMERACT Working Group on Shared Decision Making.

PubMed

Toupin-April, Karine; Barton, Jennifer; Fraenkel, Liana; Li, Linda; Grandpierre, Viviane; Guillemin, Francis; Rader, Tamara; Stacey, Dawn; Légaré, France; Jull, Janet; Petkovic, Jennifer; Scholte-Voshaar, Marieke; Welch, Vivian; Lyddiatt, Anne; Hofstetter, Cathie; De Wit, Maarten; March, Lyn; Meade, Tanya; Christensen, Robin; Gaujoux-Viala, Cécile; Suarez-Almazor, Maria E; Boonen, Annelies; Pohl, Christoph; Martin, Richard; Tugwell, Peter S

2015-12-01

Despite the importance of shared decision making for delivering patient-centered care in rheumatology, there is no consensus on how to measure its process and outcomes. The aim of this Outcome Measures in Rheumatology (OMERACT) working group is to determine the core set of domains for measuring shared decision making in intervention studies in adults with osteoarthritis (OA), from the perspectives of patients, health professionals, and researchers. We followed the OMERACT Filter 2.0 method to develop a draft core domain set by (1) forming an OMERACT working group; (2) conducting a review of domains of shared decision making; and (3) obtaining opinions of all those involved using a modified nominal group process held at a session activity at the OMERACT 12 meeting. In all, 26 people from Europe, North America, and Australia, including 5 patient research partners, participated in the session activity. Participants identified the following domains for measuring shared decision making to be included as part of the draft core set: (1) identifying the decision, (2) exchanging information, (3) clarifying views, (4) deliberating, (5) making the decision, (6) putting the decision into practice, and (7) assessing the effect of the decision. Contextual factors were also suggested. We proposed a draft core set of shared decision-making domains for OA intervention research studies. Next steps include a workshop at OMERACT 13 to reach consensus on these proposed domains in the wider OMERACT group, as well as to detail subdomains and assess instruments to develop a core outcome measurement set.

MOMENT--Management of Otitis Media with Effusion in Cleft Palate: protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey.

PubMed

Harman, Nicola L; Bruce, Iain A; Callery, Peter; Tierney, Stephanie; Sharif, Mohammad Owaise; O'Brien, Kevin; Williamson, Paula R

2013-03-12

Cleft palate (CP) has an incidence of approximately 1 in 700. Children with CP are also susceptible to otitis media with effusion (OME), with approximately 90% experiencing nontrivial OME. There are several approaches to the management of OME in children with CP. The Management of Otitis Media with Effusion in Children with Cleft Palate (MOMENT) study is a feasibility study that includes the development of a core outcome set for use in future trials of the management of OME in children with CP. The MOMENT study will include a systematic review of the literature to identify a list of outcomes that have previously been reported. This list of outcomes will be used in a Delphi study with cleft clinicians. The Delphi study is anticipated to include three rounds. The first round will ask clinicians to score the outcome list and to add any outcomes they think are relevant. The second round involves presentation of scores according to stakeholder group and the opportunity for participants to rescore outcomes. To ensure that the opinion of parents and children are sought, qualitative interviews will be completed with a purposive sample in parallel. In the final round of the Delphi process, participants will be shown the distribution of scores, for each outcome, for all stakeholder groups separately as well as a summary of the results concerning outcomes from the qualitative interviews with parents. A final consensus meeting will be held with all stakeholders, including parents and children, to review outcomes. A core outcome set represents the minimum that should be measured in a clinical trial for a particular condition. The MOMENT study will aim to identify a core outcome set that can be used in future trials of the management of OME, improving the consistency of research in this clinical area.

Report from the third international consensus meeting to harmonise core outcome measures for atopic eczema/dermatitis clinical trials (HOME)

PubMed Central

Chalmers, JR; Schmitt, J; Apfelbacher, C; Dohil, M; Eichenfield, LF; Simpson, EL; Singh, J; Spuls, P; Thomas, KS; Admani, S; Aoki, V; Ardeleanu, M; Barbarot, S; Berger, T; Bergman, JN; Block, J; Borok, N; Burton, T; Chamlin, SL; Deckert, S; DeKlotz, CC; Graff, LB; Hanifin, JM; Hebert, AA; Humphreys, R; Katoh, N; Kisa, RM; Margolis, DJ; Merhand, S; Minnillo, R; Mizutani, H; Nankervis, H; Ohya, Y; Rodgers, P; Schram, ME; Stalder, JF; Svensson, A; Takaoka, R; Teper, A; Tom, WL; von Kobyletzki, L; Weisshaar, E; Zelt, S; Williams, HC

2014-01-01

Summary This report provides a summary of the third meeting of the Harmonising Outcome Measures for Eczema (HOME) initiative held in San Diego, CA, U.S.A., 6–7 April 2013 (HOME III). The meeting addressed the four domains that had previously been agreed should be measured in every eczema clinical trial: clinical signs, patient-reported symptoms, long-term control and quality of life. Formal presentations and nominal group techniques were used at this working meeting, attended by 56 voting participants (31 of whom were dermatologists). Significant progress was made on the domain of clinical signs. Without reference to any named scales, it was agreed that the intensity and extent of erythema, excoriation, oedema/papulation and lichenification should be included in the core outcome measure for the scale to have content validity. The group then discussed a systematic review of all scales measuring the clinical signs of eczema and their measurement properties, followed by a consensus vote on which scale to recommend for inclusion in the core outcome set. Research into the remaining three domains was presented, followed by discussions. The symptoms group and quality of life groups need to systematically identify all available tools and rate the quality of the tools. A definition of long-term control is needed before progress can be made towards recommending a core outcome measure. What's already known about this topic? Many different scales have been used to measure eczema, making it difficult to compare trials in meta-analyses and hampering improvements in clinical practice. HOME core outcome measures must pass the OMERACT (Outcome Measures in Rheumatology) filter of truth (validity), discrimination (sensitivity to change and responsiveness) and feasibility (ease of use, costs, time to perform and interpret). It has been previously agreed as part of the consensus process that four domains should be measured by the core outcomes: clinical signs, patient-reported symptoms, long-term control and health-related quality of life. What does this study add? Progress was made towards developing a core outcome set for measuring eczema in clinical trials. The group established the essential items to be included in the outcome measure for the clinical signs of eczema and was able to recommend a scale for the core set. The remaining three domains of patient-reported symptoms, long-term control and health-related quality of life require further work and meetings to determine the core outcome measures. PMID:24980543

How to select outcome measurement instruments for outcomes included in a "Core Outcome Set" - a practical guideline.

PubMed

Prinsen, Cecilia A C; Vohra, Sunita; Rose, Michael R; Boers, Maarten; Tugwell, Peter; Clarke, Mike; Williamson, Paula R; Terwee, Caroline B

2016-09-13

In cooperation with the Core Outcome Measures in Effectiveness Trials (COMET) initiative, the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) initiative aimed to develop a guideline on how to select outcome measurement instruments for outcomes (i.e., constructs or domains) included in a "Core Outcome Set" (COS). A COS is an agreed minimum set of outcomes that should be measured and reported in all clinical trials of a specific disease or trial population. Informed by a literature review to identify potentially relevant tasks on outcome measurement instrument selection, a Delphi study was performed among a panel of international experts, representing diverse stakeholders. In three consecutive rounds, panelists were asked to rate the importance of different tasks in the selection of outcome measurement instruments, to justify their choices, and to add other relevant tasks. Consensus was defined as being achieved when 70 % or more of the panelists agreed and when fewer than 15 % of the panelists disagreed. Of the 481 invited experts, 120 agreed to participate of whom 95 (79 %) completed the first Delphi questionnaire. We reached consensus on four main steps in the selection of outcome measurement instruments for COS: Step 1, conceptual considerations; Step 2, finding existing outcome measurement instruments, by means of a systematic review and/or a literature search; Step 3, quality assessment of outcome measurement instruments, by means of the evaluation of the measurement properties and feasibility aspects of outcome measurement instruments; and Step 4, generic recommendations on the selection of outcome measurement instruments for outcomes included in a COS (consensus ranged from 70 to 99 %). This study resulted in a consensus-based guideline on the methods for selecting outcome measurement instruments for outcomes included in a COS. This guideline can be used by COS developers in defining how to measure core outcomes.

NETS1HD: study protocol for development of a core outcome set for use in determining the overall success of Hirschsprung's disease treatment.

PubMed

Allin, Benjamin; Bradnock, Timothy; Kenny, Simon; Walker, Gregor; Knight, Marian

2016-12-07

Use of core outcome sets in research has been proposed as a method for countering the problems caused by heterogeneity of outcome measure reporting. Heterogeneity of outcome measure reporting occurs in Hirschsprung's disease (HD) research and is limiting the development of a robust evidence base to support clinical practice. Candidate outcome measures have been identified through a systematic review. These outcome measures will form the starting point for a three-phase online Delphi process to be carried out in parallel by three panels of experts. Panel 1 is a neonatal panel; panel 2 is a non-neonatal panel; and panel 3 is a lay panel. In round 1, experts will be asked to score the previously identified outcome measures from 1 to 9 based on how important they think the measures are in determining the overall success of their/their child's/their patient's HD. In round 2, experts will be presented with the same list of outcome measures and graphical representations of how their panel scored that outcome in round 1. They will be asked to re-score the outcome measure, taking into account how important other members of their panel felt it to be. In round 3, experts will again be asked to re-score each outcome measure, but this time they will receive a graphical representation of the distribution of scores from all three panels, which they should take into account when re-scoring. Following round 3 of the Delphi process, 40 experts will be invited to attend a face-to-face consensus meeting. Participants will be invited in a purposive manner to obtain balance between the different panels. Results of the Delphi process will be discussed, and outcomes will be re-scored. Outcome measures where >70% of participants at the meeting scored it 7-9 and <15% scored it 1-3 will form the core outcome set. Development of a core outcome set will help to reduce heterogeneity of outcome measure reporting in HD. This will increase the quality of research taking place and ultimately improve care provided to infants with HD.

Development of a core set of outcome measures for OAB treatment.

PubMed

Foust-Wright, Caroline; Wissig, Stephanie; Stowell, Caleb; Olson, Elizabeth; Anderson, Anita; Anger, Jennifer; Cardozo, Linda; Cotterill, Nikki; Gormley, Elizabeth Ann; Toozs-Hobson, Philip; Heesakkers, John; Herbison, Peter; Moore, Kate; McKinney, Jessica; Morse, Abraham; Pulliam, Samantha; Szonyi, George; Wagg, Adrian; Milsom, Ian

2017-12-01

Standardized measures enable the comparison of outcomes across providers and treatments giving valuable information for improving care quality and efficacy. The aim of this project was to define a minimum standard set of outcome measures and case-mix factors for evaluating the care of patients with overactive bladder (OAB). The International Consortium for Health Outcomes Measurement (ICHOM) convened an international working group (WG) of leading clinicians and patients to engage in a structured method for developing a core outcome set. Consensus was determined by a modified Delphi process, and discussions were supported by both literature review and patient input. The standard set measures outcomes of care for adults seeking treatment for OAB, excluding residents of long-term care facilities. The WG focused on treatment outcomes identified as most important key outcome domains to patients: symptom burden and bother, physical functioning, emotional health, impact of symptoms and treatment on quality of life, and success of treatment. Demographic information and case-mix factors that may affect these outcomes were also included. The standardized outcome set for evaluating clinical care is appropriate for use by all health providers caring for patients with OAB, regardless of specialty or geographic location, and provides key data for quality improvement activities and research.

Core Outcome Measures in Effectiveness Trials (COMET) initiative: protocol for an international Delphi study to achieve consensus on how to select outcome measurement instruments for outcomes included in a 'core outcome set'.

PubMed

Prinsen, Cecilia A C; Vohra, Sunita; Rose, Michael R; King-Jones, Susanne; Ishaque, Sana; Bhaloo, Zafira; Adams, Denise; Terwee, Caroline B

2014-06-25

The Core Outcome Measures in Effectiveness Trials (COMET) initiative aims to facilitate the development and application of 'core outcome sets' (COS). A COS is an agreed minimum set of outcomes that should be measured and reported in all clinical trials of a specific disease or trial population. The overall aim of the Core Outcome Measurement Instrument Selection (COMIS) project is to develop a guideline on how to select outcome measurement instruments for outcomes included in a COS. As part of this project, we describe our current efforts to achieve a consensus on the methods for selecting outcome measurement instruments for outcomes to be included in a COS. A Delphi study is being performed by a panel of international experts representing diverse stakeholders with the intention that this will result in a guideline for outcome measurement instrument selection. Informed by a literature review, a Delphi questionnaire was developed to identify potentially relevant tasks on instrument selection. The Delphi study takes place in a series of rounds. In the first round, panelists were asked to rate the importance of different tasks in the selection of outcome measurement instruments. They were encouraged to justify their choices and to add other relevant tasks. Consensus was reached if at least 70% of the panelists considered a task 'highly recommended' or 'desirable' and if no opposing arguments were provided. These tasks will be included in the guideline. Tasks that at least 50% of the panelists considered 'not relevant' will be excluded from the guideline. Tasks that were indeterminate will be taken to the second round. All responses of the first round are currently being aggregated and will be fed back to panelists in the second round. A third round will only be performed if the results of the second round require it. Since the Delphi method allows a large group of international experts to participate, we consider it to be the preferred consensus-based method for our study. Based upon this consultation process, a guideline will be developed on instrument selection for outcomes to be included in a COS.

Standardised Outcomes in Nephrology-Children and Adolescents (SONG-Kids): a protocol for establishing a core outcome set for children with chronic kidney disease.

PubMed

Tong, Allison; Samuel, Susan; Zappitelli, Michael; Dart, Allison; Furth, Susan; Eddy, Allison; Groothoff, Jaap; Webb, Nicholas J A; Yap, Hui-Kim; Bockenhauer, Detlef; Sinha, Aditi; Alexander, Stephen I; Goldstein, Stuart L; Gipson, Debbie S; Hanson, Camilla S; Evangelidis, Nicole; Crowe, Sally; Harris, Tess; Hemmelgarn, Brenda R; Manns, Braden; Gill, John; Tugwell, Peter; Van Biesen, Wim; Wheeler, David C; Winkelmayer, Wolfgang C; Craig, Jonathan C

2016-08-12

Children with chronic kidney disease (CKD), requiring dialysis or kidney transplantation, have a mortality rate of up to 30-fold higher than the general aged-matched population, and severely impaired quality of life. Symptoms such as fatigue and pain are prevalent and debilitating. Children with CKD are at risk of cognitive impairment, and poorer educational, vocational, and psychosocial outcomes compared with their well peers, which have consequences through to adulthood. Treatment regimens for children with CKD are long-term, complex, and highly intrusive. While many trials have been conducted to improve outcomes in children with CKD, the outcomes measured and reported are often not relevant to patients and clinicians, and are highly variable. These problems can diminish the value of trials as a means to improve the lives of children with CKD. The Standardised Outcomes in Nephrology-Children and Adolescents (SONG-Kids) study aims to develop a core outcome set for trials in children and adolescents with any stage of CKD that is based on the shared priorities of all stakeholders. SONG-Kids involves five phases: a systematic review to identify outcomes (both domains and measures) that have been reported in randomised controlled trials involving children aged up to 21 years with CKD; focus groups (using nominal group technique) with adolescent patients and caregivers of paediatric patients (all ages) to identify outcomes that are relevant and important to patients and their family and the reasons for their choices; semistructured key informant interviews with health professionals involved in the care of children with CKD to ascertain their views on establishing core outcomes in paediatric nephrology; an international three-round online Delphi survey with patients, caregivers, clinicians, researchers, policy-makers, and members from industry to develop consensus on important outcome domains; and a stakeholder workshop to review and finalise the set of core outcome domains for trials in children with CKD (including nondialysis-dependent, dialysis, and kidney transplantation). Establishing a core outcome set to be reported in all trials conducted in children with any stage of CKD will enhance the relevance, transparency, and impact of research to improve the lives of children and adolescents with CKD.

Outcome Measures in Rheumatology - Interventions for medication Adherence (OMERACT-Adherence) Core Domain Set for Trials of Interventions for Medication Adherence in Rheumatology: 5 Phase Study Protocol.

PubMed

Kelly, Ayano; Tong, Allison; Tymms, Kathleen; March, Lyn; Craig, Jonathan C; De Vera, Mary; Evans, Vicki; Hassett, Geraldine; Toupin-April, Karine; van den Bemt, Bart; Teixeira-Pinto, Armando; Alten, Rieke; Bartlett, Susan J; Campbell, Willemina; Dawson, Therese; Gill, Michael; Hebing, Renske; Meara, Alexa; Nieuwlaat, Robby; Shaw, Yomei; Singh, Jasvinder A; Suarez-Almazor, Maria; Sumpton, Daniel; Wong, Peter; Christensen, Robin; Beaton, Dorcas; de Wit, Maarten; Tugwell, Peter

2018-03-27

Over the last 20 years, there have been marked improvements in the availability of effective medications for rheumatic conditions such as gout, osteoporosis and rheumatoid arthritis (RA), which have led to a reduction in disease flares and the risk of re-fracture in osteoporosis, and the slowing of disease progression in RA. However, medication adherence remains suboptimal, as treatment regimens can be complex and difficult to continue long term. Many trials have been conducted to improve adherence to medication. Core domains, which are the outcomes of most relevance to patients and clinicians, are a pivotal component of any trial. These core domains should be measured consistently, so that all relevant trials can be combined in systematic reviews and meta-analyses to reach conclusions that are more valid. Failure to do this severely limits the potential for trial-based evidence to inform decisions on how to support medication adherence. The Outcome Measures in Rheumatology (OMERACT) - Interventions for Medication Adherence study by the OMERACT-Adherence Group aims to develop a core domain set for interventions that aim to support medication adherence in rheumatology. This OMERACT-Adherence study has five phases: (1) a systematic review to identify outcome domains that have been reported in interventions focused on supporting medication adherence in rheumatology; (2) semi-structured stakeholder interviews with patients and caregivers to determine their views on the core domains; (3) focus groups using the nominal group technique with patients and caregivers to identify and rank domains that are relevant to them, including the reasons for their choices; (4) an international three-round modified Delphi survey involving patients with diverse rheumatic conditions, caregivers, health professionals, researchers and other stakeholders to develop a preliminary core domain set; and (5) a stakeholder workshop with OMERACT members to review, vote on and reach a consensus on the core domain set for interventions to support medication adherence in rheumatology. Establishing a core domain set to be reported in all intervention studies undertaken to support patients with medication adherence will enhance the relevance and the impact of these results and improve the lives of people with rheumatic conditions.

Developing a core outcome set for chronic rhinosinusitis: a systematic review of outcomes utilised in the current literature.

PubMed

Soni-Jaiswal, Archana; Lakhani, Raj; Hopkins, Claire

2017-07-11

A core outcome set (COS) is an agreed standardised collection of outcomes that should be measured and reported by all trials for a specific clinical area, in this case chronic rhinosinusitis. These are not restrictive and researchers may continue to explore other outcomes alongside these that they feel are relevant to their intervention. The aim of this systematic review was to identify the need for a COS for chronic rhinosinusitis. A sensitive search strategy was used to identify all published Cochrane systematic reviews and randomised control trials of intervention for adult patients with chronic rhinosinusitis. Two independent authors reviewed these to obtain a list of outcomes and outcome measures reported by each clinical trial. Sixty-nine randomised control trials and eight Cochrane systematic reviews were included in this study. They reported 68 individual outcomes and outcome measures, with an average of four to ten outcomes per clinical trial. These outcomes were mapped to 23 subcategories belonging to eight core categories. The key finding of this review was the heterogeneity of outcomes reported and measured by clinical trials of patients with chronic rhinosinusitis, precluding meaningful meta-analysis of data. This review supports the need for development of a COS, to be used in future trials on adult patients with chronic rhinosinusitis.

Protocol for the development of a Core Outcome Set (COS) for hemorrhoidal disease: an international Delphi study.

PubMed

van Tol, R R; Melenhorst, J; Dirksen, C D; Stassen, L P S; Breukink, S O

2017-07-01

Over the last decade, many studies were performed regarding treatment options for hemorrhoidal disease. Randomised controlled trials (RCTs) should have well-defined primary and secondary outcomes. However, the reported outcome measures are numerous and diverse. The heterogeneity of outcome definition in clinical trials limits transparency and paves the way for bias. The development of a core outcome set (COS) helps minimizing this problem. A COS is an agreed minimum set of outcomes that should be measured and reported in all clinical trials of a specific disease. The aim of this project is to generate a COS regarding the outcome of treatment after hemorrhoidal disease. A Delphi study will be performed by an international steering group healthcare professionals and patients with the intention to create a standard outcome set for future clinical trials for the treatment of hemorrhoidal disease. First, a literature review will be conducted to establish which outcomes are used in clinical trials for hemorrhoidal disease. Secondly, both healthcare professionals and patients will participate in several consecutive rounds of online questionnaires and a face-to-face meeting to refine the content of the COS. Development of a COS for hemorrhoidal disease defines a minimum outcome-reporting standard and will improve the quality of research in the future.

Orthodontic trial outcomes: Plentiful, inconsistent, and in need of uniformity? A scoping review.

PubMed

Tsichlaki, Aliki; O'Brien, Kevin; Johal, Ama; Fleming, Padhraig S

2018-06-01

The selection of appropriate outcomes that matter to both patients and operators is increasingly appreciated, with core outcome sets in clinical trials gaining in popularity. The first step in core outcome set development is the generation of a list of possible important outcomes based on a scoping literature review. Moreover, outcome heterogeneity is known to detract from the findings of systematic reviews and meta-analyses. The aim of this study was to identify the range of outcome domains and specific outcome measures in contemporary orthodontic research. Multiple electronic databases were searched from December 31, 2012, to December 31, 2016, to identify clinical trials of orthodontic interventions, with no language restrictions. Abstracts, eligible full texts, and reference lists were screened, and all reported primary and nonprimary outcomes and methods of measurement were recorded. The search identified 1267 abstracts, of which 189 full-text articles were retrieved, and 164 studies were included in the analysis. A total of 54 outcomes were identified and categorized into 14 outcome domains. The most frequently measured outcomes were patient-reported pain, periodontal health, tooth angulation/inclination changes, and treatment duration, followed by rate of tooth movement and skeletal changes. Outcomes that followed the overall course of treatment were assessed in only 14 studies. Patient perspectives are increasingly being accounted for in orthodontic trials; however, there is little consistency in outcome selection among them. The identified list of outcomes will be used to inform a ranking exercise with service users and providers to establish an agreed core outcome set for future orthodontic clinical trials. Copyright © 2018 American Association of Orthodontists. Published by Elsevier Inc. All rights reserved.

Recommended Patient-Reported Core Set of Symptoms to Measure in Adult Cancer Treatment Trials

PubMed Central

Mitchell, Sandra A.; Dueck, Amylou C.; Basch, Ethan; Cella, David; Reilly, Carolyn Miller; Minasian, Lori M.; Denicoff, Andrea M.; O’Mara, Ann M.; Fisch, Michael J.; Chauhan, Cynthia; Aaronson, Neil K.; Coens, Corneel; Bruner, Deborah Watkins

2014-01-01

Background The National Cancer Institute’s Symptom Management and Health-Related Quality of Life Steering Committee held a clinical trials planning meeting (September 2011) to identify a core symptom set to be assessed across oncology trials for the purposes of better understanding treatment efficacy and toxicity and to facilitate cross-study comparisons. We report the results of an evidence-synthesis and consensus-building effort that culminated in recommendations for core symptoms to be measured in adult cancer clinical trials that include a patient-reported outcome (PRO). Methods We used a data-driven, consensus-building process. A panel of experts, including patient representatives, conducted a systematic review of the literature (2001–2011) and analyzed six large datasets. Results were reviewed at a multistakeholder meeting, and a final set was derived emphasizing symptom prevalence across diverse cancer populations, impact on health outcomes and quality of life, and attribution to either disease or anticancer treatment. Results We recommend that a core set of 12 symptoms—specifically fatigue, insomnia, pain, anorexia (appetite loss), dyspnea, cognitive problems, anxiety (includes worry), nausea, depression (includes sadness), sensory neuropathy, constipation, and diarrhea—be considered for inclusion in clinical trials where a PRO is measured. Inclusion of symptoms and other patient-reported endpoints should be well justified, hypothesis driven, and meaningful to patients. Conclusions This core set will promote consistent assessment of common and clinically relevant disease- and treatment-related symptoms across cancer trials. As such, it provides a foundation to support data harmonization and continued efforts to enhance measurement of patient-centered outcomes in cancer clinical trials and observational studies. PMID:25006191

Development of a core outcome set for use in determining the overall success of gastroschisis treatment.

PubMed

Allin, Benjamin; Ross, Andrew; Marven, Sean; J Hall, Nigel; Knight, Marian

2016-07-27

Gastroschisis research is limited in quality by the presence of significant heterogeneity in outcome measure reporting (PloS One 10(1):e0116908, 2015). Using core outcome sets in research is one proposed method for addressing this problem (Trials 13:103, 2012; Clin Rheumatol 33(9):1313-1322, 2014; Health Serv Res Policy 17(1):1-2, 2012). Ultimately, standardising outcome measure reporting will improve research quality and translate into improvements in patient care. Candidate outcome measures have been identified through systematic reviews. These outcome measures will form the starting point for an online, three-phase Delphi process that will be carried out in parallel by three panels of experts. Panel 1 is a neonatal panel, panel 2 is a non-neonatal panel and panel 3 is a lay panel. In round 1, experts will be asked to score the previously identified outcome measures from 1-9 based on how important they think the measures are in determining the overall success of their/their child's/their patient's gastroschisis treatment. In round 2, experts will be presented with the same list of outcome measures and with graphical representations of how their panel scored that outcome in round 1. They will be asked to re-score the outcome measure taking into account how important other members of their panel felt it to be. In round 3, experts will again be asked to re-score each outcome measure, but this time they will receive a graphical representation of the distribution of scores from all three panels which they should take into account when re-scoring. Following round 3 of the Delphi process, 40 experts will be invited to attend a face-to-face consensus meeting. Participants will be invited in a purposive manner to obtain balance between the different panels. The results of the Delphi process will be discussed, and outcomes re-scored. Outcome measures where > 70 % of the participants at the meeting scored them as 7-9 and < 15 % scored them as 1-3 will form the core outcome set. Development of a core outcome set will help to reduce the heterogeneity of the outcome measure reporting in gastroschisis. This will increase the quality of research taking place and ultimately improve care provided to infants with gastroschisis.

Service profiling and outcomes benchmarking using the CORE-OM: toward practice-based evidence in the psychological therapies. Clinical Outcomes in Routine Evaluation-Outcome Measures.

PubMed

Barkham, M; Margison, F; Leach, C; Lucock, M; Mellor-Clark, J; Evans, C; Benson, L; Connell, J; Audin, K; McGrath, G

2001-04-01

To complement the evidence-based practice paradigm, the authors argued for a core outcome measure to provide practice-based evidence for the psychological therapies. Utility requires instruments that are acceptable scientifically, as well as to service users, and a coordinated implementation of the measure at a national level. The development of the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is summarized. Data are presented across 39 secondary-care services (n = 2,710) and within an intensively evaluated single service (n = 1,455). Results suggest that the CORE-OM is a valid and reliable measure for multiple settings and is acceptable to users and clinicians as well as policy makers. Baseline data levels of patient presenting problem severity, including risk, are reported in addition to outcome benchmarks that use the concept of reliable and clinically significant change. Basic quality improvement in outcomes for a single service is considered.

A Core Outcome Set for Evaluation of Interventions to Prevent Preterm Birth.

PubMed

van ʼt Hooft, Janneke; Duffy, James M N; Daly, Mandy; Williamson, Paula R; Meher, Shireen; Thom, Elizabeth; Saade, George R; Alfirevic, Zarko; Mol, Ben Willem J; Khan, Khalid S

2016-01-01

To develop a consensus on a set of key clinical outcomes for the evaluation of preventive interventions for preterm birth in asymptomatic pregnant women. A two-stage web-based Delphi survey and a face-to-face meeting of key stakeholders were used to develop a consensus on a set of critical and important outcomes. We approached five stakeholder groups (parents, midwives, obstetricians, neonatologists, and researchers) from middle- and high-income countries. Outcomes subjected to the Delphi survey were identified by systematic literature review and stakeholder input. Survey participants scored each outcome on a 9-point Likert scale anchored between 1 (limited importance) and 9 (critical importance). They had the opportunity to reflect on total and stakeholder subgroup feedback between survey stages. For consensus, defined a priori, outcomes required at least 70% of participants of each stakeholder group to score them as "critical" and less than 15% as "limited." A total of 228 participants from five stakeholder groups from three lower middle-income countries, seven upper middle-income countries, and 17 high-income countries were asked to score 31 outcomes. Of these participants, 195 completed the first survey and 174 the second. Consensus was reached on 13 core outcomes: four were related to pregnant women: maternal mortality, maternal infection or inflammation, prelabor rupture of membranes, and harm to mother from intervention. Nine were related to offspring: gestational age at birth, offspring mortality, birth weight, early neurodevelopmental morbidity, late neurodevelopmental morbidity, gastrointestinal morbidity, infection, respiratory morbidity, and harm to offspring from intervention. This core outcome set for studies that evaluate prevention of preterm birth developed with an international multidisciplinary perspective will ensure that data from trials that assess prevention of preterm birth can be compared and combined. COMET Initiative, http://www.comet-initiative.org/studies/details/603, REGISTRATION NUMBER: 603.

Core outcome domains for clinical trials in non-specific low back pain.

PubMed

Chiarotto, Alessandro; Deyo, Richard A; Terwee, Caroline B; Boers, Maarten; Buchbinder, Rachelle; Corbin, Terry P; Costa, Leonardo O P; Foster, Nadine E; Grotle, Margreth; Koes, Bart W; Kovacs, Francisco M; Lin, Chung-Wei Christine; Maher, Chris G; Pearson, Adam M; Peul, Wilco C; Schoene, Mark L; Turk, Dennis C; van Tulder, Maurits W; Ostelo, Raymond W

2015-06-01

Inconsistent reporting of outcomes in clinical trials of patients with non-specific low back pain (NSLBP) hinders comparison of findings and the reliability of systematic reviews. A core outcome set (COS) can address this issue as it defines a minimum set of outcomes that should be reported in all clinical trials. In 1998, Deyo et al. recommended a standardized set of outcomes for LBP clinical research. The aim of this study was to update these recommendations by determining which outcome domains should be included in a COS for clinical trials in NSLBP. An International Steering Committee established the methodology to develop this COS. The OMERACT Filter 2.0 framework was used to draw a list of potential core domains that were presented in a Delphi study. Researchers, care providers and patients were invited to participate in three Delphi rounds and were asked to judge which domains were core. A priori criteria for consensus were established before each round and were analysed together with arguments provided by panellists on importance, overlap, aggregation and/or addition of potential core domains. The Steering Committee discussed the final results and made final decisions. A set of 280 experts was invited to participate in the Delphi; response rates in the three rounds were 52, 50 and 45%. Of 41 potential core domains presented in the first round, 13 had sufficient support to be presented for rating in the third round. Overall consensus was reached for the inclusion of three domains in this COS: 'physical functioning', 'pain intensity' and 'health-related quality of life'. Consensus on 'physical functioning' and 'pain intensity' was consistent across all stakeholders, 'health-related quality of life' was not supported by the patients, and all the other domains were not supported by two or more groups of stakeholders. Weighting all possible argumentations, the Steering Committee decided to include in the COS the three domains that reached overall consensus and the domain 'number of deaths'. The following outcome domains were included in this updated COS: 'physical functioning', 'pain intensity', 'health-related quality of life' and 'number of deaths'. The next step for the development of this COS will be to determine which measurement instruments best measure these domains.

Towards global consensus on outcome measures for atopic eczema research: results of the HOME II meeting.

PubMed

Schmitt, Jochen; Spuls, Phyllis; Boers, Maarten; Thomas, Kim; Chalmers, Joanne; Roekevisch, Evelien; Schram, Mandy; Allsopp, Richard; Aoki, Valeria; Apfelbacher, Christian; Bruijnzeel-Koomen, Carla; Bruin-Weller, Marjolein; Charman, Carolyn; Cohen, Arnon; Dohil, Magdalene; Flohr, Carsten; Furue, Masutaka; Gieler, Uwe; Hooft, Lotty; Humphreys, Rosemary; Ishii, Henrique Akira; Katayama, Ichiro; Kouwenhoven, Willem; Langan, Sinéad; Lewis-Jones, Sue; Merhand, Stephanie; Murota, Hiroyuki; Murrell, Dedee F; Nankervis, Helen; Ohya, Yukihiro; Oranje, Arnold; Otsuka, Hiromi; Paul, Carle; Rosenbluth, Yael; Saeki, Hidehisa; Schuttelaar, Marie-Louise; Stalder, Jean-Francois; Svensson, Ake; Takaoka, Roberto; Wahlgren, Carl-Fredrik; Weidinger, Stephan; Wollenberg, Andreas; Williams, Hywel

2012-09-01

The use of nonstandardized and inadequately validated outcome measures in atopic eczema trials is a major obstacle to practising evidence-based dermatology. The Harmonising Outcome Measures for Eczema (HOME) initiative is an international multiprofessional group dedicated to atopic eczema outcomes research. In June 2011, the HOME initiative conducted a consensus study involving 43 individuals from 10 countries, representing different stakeholders (patients, clinicians, methodologists, pharmaceutical industry) to determine core outcome domains for atopic eczema trials, to define quality criteria for atopic eczema outcome measures and to prioritize topics for atopic eczema outcomes research. Delegates were given evidence-based information, followed by structured group discussion and anonymous consensus voting. Consensus was achieved to include clinical signs, symptoms, long-term control of flares and quality of life into the core set of outcome domains for atopic eczema trials. The HOME initiative strongly recommends including and reporting these core outcome domains as primary or secondary endpoints in all future atopic eczema trials. Measures of these core outcome domains need to be valid, sensitive to change and feasible. Prioritized topics of the HOME initiative are the identification/development of the most appropriate instruments for the four core outcome domains. HOME is open to anyone with an interest in atopic eczema outcomes research. © 2012 John Wiley & Sons A/S.

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.

Patient Endorsement of the Outcome Measures in Rheumatology (OMERACT) Total Joint Replacement (TJR) clinical trial draft core domain set.

PubMed

Singh, Jasvinder A; Dowsey, Michelle; Choong, Peter F

2017-03-15

A patient- and surgeon-Delphi-derived Outcome Measures in Rheumatology (OMERACT) draft core domain set for total joint arthroplasty (TJR) trials was recently developed. Our objective was to obtain further patient stakeholder endorsement of draft core domain set for TJR clinical trials. We surveyed two patient groups: (1) OMERACT patient partners; and (2) patients who had undergone hip or knee TJR. Patients received an introductory email with explanations about the core domain set and instructions to rate the core domains, i.e., important aspects, of OMERACT TJR clinical trial draft core domain set. Rating was on a nominal scale, where 1-3 indicated a domain of limited importance, 4-6 an important, but not critical domain, and 7-9 a critical domain. We used Mann-Whitney test (a non-parametric test) to compare the distribution of ratings between the two groups. Thirty one survey participants from the OMERACT patient partner group and 118 knee/hip TJR patients responded with response rates of 66 and 80%, respectively. Majority of the survey respondents were female, 87 vs. 53%, and were 55 years or older, 57 vs. 94%. Median (interquartile range [IQR]) scores for six core domains by OMERACT and knee/hip TJR patient groups were, respectively: pain, 8 [8, 9] and 9 [8, 9]; function, 9 [8, 9] and 9 [8, 9]; patient satisfaction, 8 [8, 9] and 8 [7, 9]; revision surgery, 7 [7, 8] and 7 [5, 9]; adverse events, 8 [7, 9] and 8 [6, 9]; and death, 9 [6, 9] and 9 [4, 9]. No statistically significant differences in rating were noted for any of the six core domains between the two groups (p ≥ 0.31). Among the additional domains, ratings for patient participation did not differ by group (p = 0.98), but ratings for cost were significantly different (p = 0.005). Patients provided qualitative feedback regarding core domains, and did not propose any modifications to the draft core domain set. Two separate patient stakeholder groups endorsed the OMERACT TJR draft core domain set for TJR trials.

Evaluation of interventions for informed consent for randomised controlled trials (ELICIT): protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey.

PubMed

Gillies, Katie; Entwistle, Vikki; Treweek, Shaun P; Fraser, Cynthia; Williamson, Paula R; Campbell, Marion K

2015-10-27

The process of obtaining informed consent for participation in randomised controlled trials (RCTs) was established as a mechanism to protect participants against undue harm from research and allow people to recognise any potential risks or benefits associated with the research. A number of interventions have been put forward to improve this process. Outcomes reported in trials of interventions to improve the informed consent process for decisions about trial participation tend to focus on the 'understanding' of trial information. However, the operationalization of understanding as a concept, the tools used to measure it and the timing of the measurements are heterogeneous. A lack of clarity exists regarding which outcomes matter (to whom) and why. This inconsistency between studies results in difficulties when making comparisons across studies as evidenced in two recent systematic reviews of informed consent interventions. As such, no optimal method for measuring the impact of these interventions aimed at improving informed consent for RCTs has been identified. The project will adopt and adapt methodology previously developed and used in projects developing core outcome sets for assessment of clinical treatments. Specifically, the work will consist of three stages: 1) A systematic methodology review of existing outcome measures of trial informed consent interventions; 2) Interviews with key stakeholders to explore additional outcomes relevant for trial participation decisions; and 3) A Delphi study to refine the core outcome set for evaluation of trial informed consent interventions. All stages will include the stakeholders involved in the various aspects of RCT consent: users (that is, patients), developers (that is, trialists), deliverers (focusing on research nurses) and authorisers (that is, ethics committees). A final consensus meeting including all stakeholders will be held to review outcomes. The ELICIT study aims to develop a core outcome set for the evaluation of interventions intended to improve informed consent for RCTs for use in future RCTs and reviews, thereby improving the reliability and consistency of research in this area.

Evaluation of the measurement properties of symptom measurement instruments for atopic eczema: a systematic review.

PubMed

Gerbens, L A A; Prinsen, C A C; Chalmers, J R; Drucker, A M; von Kobyletzki, L B; Limpens, J; Nankervis, H; Svensson, Å; Terwee, C B; Zhang, J; Apfelbacher, C J; Spuls, P I

2017-01-01

Symptoms have been identified as a core outcome domain for atopic eczema (AE) trials. Various instruments exist to measure symptoms in AE, but they vary in quality and there is a lack of standardization between clinical trials. Our objective was to systematically evaluate the quality of the evidence on the measurement properties of AE symptom instruments, thereby informing consensus discussions within the Harmonising Outcome Measures for Eczema (HOME) initiative regarding the most appropriate instruments for the core outcome domain symptoms. Using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist and predefined criteria for good measurement properties on identified development and validation studies of AE symptom instruments, a best evidence synthesis was performed to draw an overall conclusion on quality of the instruments and to provide recommendations. Eighteen instruments were identified and evaluated. When the quality and results of the studies were considered, only five of these instruments had sufficient validation data to consider them for the core outcome set for the core outcome domain symptoms. These were the paediatric Itch Severity Scale (ISS), Patient-Oriented Eczema Measure (POEM), Patient-Oriented SCOring Atopic Dermatitis (PO-SCORAD), Self-Administered Eczema Area and Severity Index (SA-EASI) and adapted SA-EASI. ISS (paediatric version), POEM, PO-SCORAD, SA-EASI and adapted SA-EASI are currently the most appropriate instruments and therefore have the potential to be recommended as core symptom instrument in future clinical trials. These findings will be utilized for the development of a core outcome set for AE. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Development of a Draft Core Set of Domains for Measuring Shared Decision Making in Osteoarthritis: An OMERACT Working Group on Shared Decision Making

PubMed Central

Toupin April, Karine; Barton, Jennifer; Fraenkel, Liana; Li, Linda; Grandpierre, Viviane; Guillemin, Francis; Rader, Tamara; Stacey, Dawn; Légaré, France; Jull, Janet; Petkovic, Jennifer; Scholte Voshaar, Marieke; Welch, Vivian; Lyddiatt, Anne; Hofstetter, Cathie; De Wit, Maarten; March, Lyn; Meade, Tanya; Christensen, Robin; Gaujoux-Viala, Cécile; Suarez-Almazor, Maria E.; Boonen, Annelies; Pohl, Christoph; Martin, Richard; Tugwell, Peter

2015-01-01

Objective Despite the importance of shared decision making for delivering patient-centred care in rheumatology, there is no consensus on how to measure its process and outcomes. The aim of this OMERACT working group is to determine the core set of domains for measuring shared decision making in intervention studies in adults with osteoarthritis (OA), from the perspective of patients, health professionals and researchers. Methods We followed the OMERACT Filter 2.0 to develop a draft core domain set, which consisted of: (i) forming an OMERACT working group; (ii) conducting a review of domains of shared decision making; and (iii) obtaining the opinions of stakeholders using a modified nominal group process held at a session activity at the OMERACT 2014 meeting. Results 26 stakeholders from Europe, North America and Australia, including 5 patient research partners, participated in the session activity. Participants identified the following domains for measuring shared decision making to be included as part of the Draft Core Set: 1) Identifying the decision; 2) Exchanging Information; 3) Clarifying views; 4) Deliberating; 5) Making the decision; 6) Putting the decision into practice; and 7) Assessing the impact of the decision. Contextual factors were also suggested. Conclusion We propose a Draft Core Set of shared decision making domains for OA intervention research studies. Next steps include a workshop at OMERACT 2016 to reach consensus on these proposed domains in the wider OMERACT group, as well as detail sub-domains and assess instruments to develop a Core Outcome Measurement Set. PMID:25877502

Why simulation can be efficient: on the preconditions of efficient learning in complex technology based practices.

PubMed

Hofmann, Bjørn

2009-07-23

It is important to demonstrate learning outcomes of simulation in technology based practices, such as in advanced health care. Although many studies show skills improvement and self-reported change to practice, there are few studies demonstrating patient outcome and societal efficiency. The objective of the study is to investigate if and why simulation can be effective and efficient in a hi-tech health care setting. This is important in order to decide whether and how to design simulation scenarios and outcome studies. Core theoretical insights in Science and Technology Studies (STS) are applied to analyze the field of simulation in hi-tech health care education. In particular, a process-oriented framework where technology is characterized by its devices, methods and its organizational setting is applied. The analysis shows how advanced simulation can address core characteristics of technology beyond the knowledge of technology's functions. Simulation's ability to address skilful device handling as well as purposive aspects of technology provides a potential for effective and efficient learning. However, as technology is also constituted by organizational aspects, such as technology status, disease status, and resource constraints, the success of simulation depends on whether these aspects can be integrated in the simulation setting as well. This represents a challenge for future development of simulation and for demonstrating its effectiveness and efficiency. Assessing the outcome of simulation in education in hi-tech health care settings is worthwhile if core characteristics of medical technology are addressed. This challenges the traditional technical versus non-technical divide in simulation, as organizational aspects appear to be part of technology's core characteristics.

Establishing Core Outcome Domains in Hemodialysis: Report of the Standardized Outcomes in Nephrology−Hemodialysis (SONG-HD) Consensus Workshop

PubMed Central

Tong, Allison; Manns, Braden; Hemmelgarn, Brenda; Wheeler, David C.; Evangelidis, Nicole; Tugwell, Peter; Crowe, Sally; Van Biesen, Wim; Winkelmayer, Wolfgang C.; O’Donoghue, Donal; Tam-Tham, Helen; Shen, Jenny; Pinter, Jule; Larkins, Nicholas; Youssouf, Sajeda; Mandayam, Sreedhar; Ju, Angela; Craig, Jonathan C.

2017-01-01

Evidence-informed decision-making in clinical care and policy in nephrology is undermined by trials that selectively report a large number of heterogeneous outcomes, many of which are not patient-centered. The Standardized Outcomes in Nephrology−Hemodialysis (SONG-HD) Initiative convened an international consensus workshop on November 7, 2015, to discuss the identification and implementation of a potential core outcome set for all trials in hemodialysis. The purpose of this article is to report qualitative analyses of the workshop discussions, describing the key aspects to consider when establishing core outcomes in trials involving patients on hemodialysis. Key stakeholders including eight patients/caregivers and 47 health professionals (nephrologists, policy makers, industry, researchers) attended the workshop. Attendees suggested that identifying core outcomes required equitable stakeholder engagement to ensure relevance across patient populations; flexibility to consider evolving priorities over time; deconstruction of language and meaning for conceptual consistency and clarity; understanding of potential overlap and associations between outcomes; and an assessment of applicability to the range of interventions in hemodialysis. For implementation, they proposed that core outcomes must have simple, inexpensive and validated outcome measures that could be used in clinical care (quality ndicators) and trials (including pragmatic trials), and endorsement by regulatory agencies. Integrating these recommendations may foster acceptance and optimize the uptake and translation of core outcomes in hemodialysis, leading to more informative research, for better treatment, and improved patient outcomes. PMID:27497527

Establishing Core Outcome Domains in Hemodialysis: Report of the Standardized Outcomes in Nephrology-Hemodialysis (SONG-HD) Consensus Workshop.

PubMed

Tong, Allison; Manns, Braden; Hemmelgarn, Brenda; Wheeler, David C; Evangelidis, Nicole; Tugwell, Peter; Crowe, Sally; Van Biesen, Wim; Winkelmayer, Wolfgang C; O'Donoghue, Donal; Tam-Tham, Helen; Shen, Jenny I; Pinter, Jule; Larkins, Nicholas; Youssouf, Sajeda; Mandayam, Sreedhar; Ju, Angela; Craig, Jonathan C

2017-01-01

Evidence-informed decision making in clinical care and policy in nephrology is undermined by trials that selectively report a large number of heterogeneous outcomes, many of which are not patient centered. The Standardized Outcomes in Nephrology-Hemodialysis (SONG-HD) Initiative convened an international consensus workshop on November 7, 2015, to discuss the identification and implementation of a potential core outcome set for all trials in hemodialysis. The purpose of this article is to report qualitative analyses of the workshop discussions, describing the key aspects to consider when establishing core outcomes in trials involving patients on hemodialysis therapy. Key stakeholders including 8 patients/caregivers and 47 health professionals (nephrologists, policymakers, industry, and researchers) attended the workshop. Attendees suggested that identifying core outcomes required equitable stakeholder engagement to ensure relevance across patient populations, flexibility to consider evolving priorities over time, deconstruction of language and meaning for conceptual consistency and clarity, understanding of potential overlap and associations between outcomes, and an assessment of applicability to the range of interventions in hemodialysis. For implementation, they proposed that core outcomes must have simple, inexpensive, and validated outcome measures that could be used in clinical care (quality indicators) and trials (including pragmatic trials) and endorsement by regulatory agencies. Integrating these recommendations may foster acceptance and optimize the uptake and translation of core outcomes in hemodialysis, leading to more informative research, for better treatment and improved patient outcomes. Copyright © 2016 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

Core Outcome Set-STAndards for Development: The COS-STAD recommendations.

PubMed

Kirkham, Jamie J; Davis, Katherine; Altman, Douglas G; Blazeby, Jane M; Clarke, Mike; Tunis, Sean; Williamson, Paula R

2017-11-01

The use of core outcome sets (COS) ensures that researchers measure and report those outcomes that are most likely to be relevant to users of their research. Several hundred COS projects have been systematically identified to date, but there has been no formal quality assessment of these studies. The Core Outcome Set-STAndards for Development (COS-STAD) project aimed to identify minimum standards for the design of a COS study agreed upon by an international group, while other specific guidance exists for the final reporting of COS development studies (Core Outcome Set-STAndards for Reporting [COS-STAR]). An international group of experienced COS developers, methodologists, journal editors, potential users of COS (clinical trialists, systematic reviewers, and clinical guideline developers), and patient representatives produced the COS-STAD recommendations to help improve the quality of COS development and support the assessment of whether a COS had been developed using a reasonable approach. An open survey of experts generated an initial list of items, which was refined by a 2-round Delphi survey involving nearly 250 participants representing key stakeholder groups. Participants assigned importance ratings for each item using a 1-9 scale. Consensus that an item should be included in the set of minimum standards was defined as at least 70% of the voting participants from each stakeholder group providing a score between 7 and 9. The Delphi survey was followed by a consensus discussion with the study management group representing multiple stakeholder groups. COS-STAD contains 11 minimum standards that are the minimum design recommendations for all COS development projects. The recommendations focus on 3 key domains: the scope, the stakeholders, and the consensus process. The COS-STAD project has established 11 minimum standards to be followed by COS developers when planning their projects and by users when deciding whether a COS has been developed using reasonable methods.

Core outcome sets for prevention and treatment of postpartum haemorrhage: an international Delphi consensus study.

PubMed

Meher, Shireen; Cuthbert, Anna; Kirkham, Jamie J; Williamson, Paula; Abalos, Edgardo; Aflaifel, Nasreen; Bhutta, Zulfiqar A; Bishop, Alina; Blum, Jennifer; Collins, Peter; Devane, Declan; Ducloy-Bouthors, Anne-Sophie; Fawole, Bukola; Gülmezoglu, A Metin; Gutteridge, Kathryn; Gyte, Gill; Homer, Caroline S E; Mallaiah, Shuba; Smith, Jeffrey M; Weeks, Andrew D; Alfirevic, Zarko

2018-06-19

To develop core outcome sets (COS) for studies evaluating interventions for (1) prevention and (2) treatment of PPH, and recommendations on how to report the COS. A two-round Delphi survey and face-to-face meeting. Health care professionals and women's representatives. Outcomes were identified from systematic reviews of PPH studies and stakeholder consultation. Participants scored each outcome in the Delphi on a Likert scale between 1 (not important) and 9 (critically important). Results were discussed at the face-to-face meeting to agree the final COS. Consensus at the meeting was defined as ≥ 70% of participants scoring the outcome as critically important (7-9). Lectures, discussion and voting were used to agree how to report COS outcomes. outcomes from systematic reviews and consultations. Both Delphi rounds were completed by 152/205 (74%) participants for prevention and 143/197 (73%) for treatment. For prevention of PPH, nine core outcomes were selected: blood loss, shock, maternal death, use of additional uterotonics, blood transfusion, transfer for higher level of care, women's sense of wellbeing, acceptability and satisfaction with the intervention, breastfeeding and adverse effects. For treatment of PPH, 12 core outcomes were selected: blood loss, shock, coagulopathy, hysterectomy, organ dysfunction, maternal death, blood transfusion, use of additional haemostatic intervention, transfer for higher level of care, women's sense of wellbeing, acceptability and satisfaction with the intervention, breastfeeding and adverse effects. Recommendations were developed on how to report these outcomes where possible. These COS will help standardise outcome reporting in PPH trials. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Core outcome measures for exercise studies in people with multiple sclerosis: recommendations from a multidisciplinary consensus meeting.

PubMed

Paul, Lorna; Coote, Susan; Crosbie, Jean; Dixon, Diane; Hale, Leigh; Holloway, Ed; McCrone, Paul; Miller, Linda; Saxton, John; Sincock, Caroline; White, Lesley

2014-10-01

Evidence shows that exercise is beneficial for people with multiple sclerosis (MS); however, statistical pooling of data is difficult because of the diversity of outcome measures used. The objective of this review is to report the recommendations of an International Consensus Meeting for a core set of outcome measures for use in exercise studies in MS. From the 100 categories of the International Classification of Function Core Sets for MS, 57 categories were considered as likely/potentially likely to be affected by exercise and were clustered into seven core groups. Outcome measures to address each group were evaluated regarding, for example, psychometric properties. The following are recommended: Modified Fatigue Impact Scale (MFIS) or Fatigue Severity Scale (FSS) for energy and drive, 6-Minute Walk Test (6MWT) for exercise tolerance, Timed Up and Go (TUG) for muscle function and moving around, Multiple Sclerosis Impact Scale (MSIS-29) or Multiple Sclerosis Quality of Life-54 Instrument (MSQoL54) for quality of life and body mass index (BMI) or waist-hip ratio (WHR) for the health risks associated with excess body fat. A cost effectiveness analysis and qualitative evaluation should be included where possible. Using these core measures ensures that future meta-analyses of exercise studies in MS are more robust and thus more effectively inform practice. © The Author(s) 2014.

Identification of a core-periphery structure among participants of a business climate survey. An investigation based on the ZEW survey data

NASA Astrophysics Data System (ADS)

Stolzenburg, U.; Lux, T.

2011-12-01

Processes of social opinion formation might be dominated by a set of closely connected agents who constitute the cohesive `core' of a network and have a higher influence on the overall outcome of the process than those agents in the more sparsely connected `periphery'. Here we explore whether such a perspective could shed light on the dynamics of a well known economic sentiment index. To this end, we hypothesize that the respondents of the survey under investigation form a core-periphery network, and we identify those agents that define the core (in a discrete setting) or the proximity of each agent to the core (in a continuous setting). As it turns out, there is significant correlation between the so identified cores of different survey questions. Both the discrete and the continuous cores allow an almost perfect replication of the original series with a reduced data set of core members or weighted entries according to core proximity. Using a monthly time series on industrial production in Germany, we also compared experts' predictions with the real economic development. The core members identified in the discrete setting showed significantly better prediction capabilities than those agents assigned to the periphery of the network.

The Anatomical Society core regional anatomy syllabus for undergraduate medicine.

PubMed

Smith, C F; Finn, G M; Stewart, J; Atkinson, M A; Davies, D C; Dyball, R; Morris, J; Ockleford, C; Parkin, I; Standring, S; Whiten, S; Wilton, J; McHanwell, S

2016-01-01

The Anatomical Society's core syllabus for anatomy (2003 and later refined in 2007) set out a series of learning outcomes that an individual medical student should achieve on graduation. The core syllabus, with 182 learning outcomes grouped in body regions, referenced in the General Medical Council's Teaching Tomorrow's Doctors, was open to criticism on the grounds that the learning outcomes were generated by a relatively small group of anatomists, albeit some of whom were clinically qualified. We have therefore used a modified Delphi technique to seek a wider consensus. A Delphi panel was constructed involving 'experts' (n = 39). The revised core syllabus of 156 learning outcomes presented here is applicable to all medical programmes and may be used by curriculum planners, teachers and students alike in addressing the perennial question: 'What do I need to know ?' © 2015 Anatomical Society.

Developing a set of consensus indicators to support maternity service quality improvement: using Core Outcome Set methodology including a Delphi process.

PubMed

Bunch, K J; Allin, B; Jolly, M; Hardie, T; Knight, M

2018-05-16

To develop a core metric set to monitor the quality of maternity care. Delphi process followed by a face-to-face consensus meeting. English maternity units. Three representative expert panels: service designers, providers and users. Maternity care metrics judged important by participants. Participants were asked to complete a two-phase Delphi process, scoring metrics from existing local maternity dashboards. A consensus meeting discussed the results and re-scored the metrics. In all, 125 distinct metrics across six domains were identified from existing dashboards. Following the consensus meeting, 14 metrics met the inclusion criteria for the final core set: smoking rate at booking; rate of birth without intervention; caesarean section delivery rate in Robson group 1 women; caesarean section delivery rate in Robson group 2 women; caesarean section delivery rate in Robson group 5 women; third- and fourth-degree tear rate among women delivering vaginally; rate of postpartum haemorrhage of ≥1500 ml; rate of successful vaginal birth after a single previous caesarean section; smoking rate at delivery; proportion of babies born at term with an Apgar score <7 at 5 minutes; proportion of babies born at term admitted to the neonatal intensive care unit; proportion of babies readmitted to hospital at <30 days of age; breastfeeding initiation rate; and breastfeeding rate at 6-8 weeks. Core outcome set methodology can be used to incorporate the views of key stakeholders in developing a core metric set to monitor the quality of care in maternity units, thus enabling improvement. Achieving consensus on core metrics for monitoring the quality of maternity care. © 2018 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd on behalf of Royal College of Obstetricians and Gynaecologists.

How to apply the ICF and ICF core sets for low back pain.

PubMed

Stier-Jarmer, Marita; Cieza, Alarcos; Borchers, Michael; Stucki, Gerold

2009-01-01

To introduce the International Classification of Functioning, Disability and Health (ICF) as conceptual model and classification and the ICF Core Sets as a way to specify functioning for a specific health condition such as Low Back Pain, and to illustrate the application of the ICF and ICF Core Sets in the context of clinical practice, the planning and reporting of studies and the comparison of health status measures. A decision-making and consensus process was performed to develop the ICF Core Sets for Low Back Pain, the linking procedure was applied as basis for the content comparison of health-status measures and the Rehab-Cycle was used to exemplify the application of the ICE and ICF Core Sets in clinical practice. Two different ICF Core Sets, namely, a comprehensive and a brief, are presented, three different health-status measures were linked to the ICF and compared and a case example of a patient with Low back Pain was described based on the Rehab-Cycle. The ICF is a promising new framework and classification to assess the impact of Low Back Pain. The ICF and practical tools, such as the ICF Core Sets for Low Back Pain, are useful for clinical practice, outcome and rehabilitation research, education, health statistics, and regulation.

Identification of a Core Set of Exercise Tests for Children and Adolescents with Cerebral Palsy: A Delphi Survey of Researchers and Clinicians

ERIC Educational Resources Information Center

Verschuren, Olaf; Ketelaar, Marjolijn; Keefer, Daniel; Wright, Virginia; Butler, Jane; Ada, Louise; Maher, Carol; Reid, Siobhan; Wright, Marilyn; Dalziel, Blythe; Wiart, Lesley; Fowler, Eileen; Unnithan, Viswanath; Maltais, Desiree B.; van den Berg-Emons, Rita; Takken, Tim

2011-01-01

Aim: Evidence-based recommendations regarding which exercise tests to use in children and adolescents with cerebral palsy (CP) are lacking. This makes it very difficult for therapists and researchers to choose the appropriate exercise-related outcome measures for this group. This study aimed to identify a core set of exercise tests for children…

Development of a Core Set of Outcome Measures for Large-vessel Vasculitis: Report from OMERACT 2016.

PubMed

Sreih, Antoine G; Alibaz-Oner, Fatma; Kermani, Tanaz A; Aydin, Sibel Z; Cronholm, Peter F; Davis, Trocon; Easley, Ebony; Gul, Ahmet; Mahr, Alfred; McAlear, Carol A; Milman, Nataliya; Robson, Joanna C; Tomasson, Gunnar; Direskeneli, Haner; Merkel, Peter A

2017-12-01

Among the challenges in conducting clinical trials in large-vessel vasculitis (LVV), including both giant cell arteritis (GCA) and Takayasu arteritis (TA), is the lack of standardized and meaningful outcome measures. The Outcome Measures in Rheumatology (OMERACT) Vasculitis Working Group initiated an international effort to develop and validate data-driven outcome tools for clinical investigation in LVV. An international Delphi exercise was completed to gather opinions from clinical experts on LVV-related domains considered important to measure in trials. Patient interviews and focus groups were completed to identify outcomes of importance to patients. The results of these activities were presented and discussed in a "Virtual Special Interest Group" using telephone- and Internet-based conferences, discussions through electronic mail, and an in-person session at the 2016 OMERACT meeting. A preliminary core set of domains common for all forms of LVV with disease-specific elements was proposed. The majority of experts agree with using common outcome measures for GCA and TA, with the option of supplementation with disease-specific items. Following interviews and focus groups, pain, fatigue, and emotional effect emerged as health-related quality of life domains important to patients. Current disease assessment tools, including the Birmingham Vasculitis Activity Score, were found to be inadequate to assess disease activity in GCA and standardized assessment of imaging tests were felt crucial to study LVV, especially TA. Initial data from a clinician Delphi exercise and structured patient interviews have provided themes toward an OMERACT-endorsed core set of domains and outcome measures.

Towards global consensus on core outcomes for hidradenitis suppurativa research: an update from the HISTORIC consensus meetings I and II*

PubMed Central

Thorlacius, L.; Garg, A.; Ingram, J.R.; Villumsen, B.; Riis, P. Theut; Gottlieb, A.B.; Merola, J.F.; Dellavalle, R.; Ardon, C.; Baba, R.; Bechara, F.G.; Cohen, A.D.; Daham, N.; Davis, M.; Emtestam, L.; Fernández-Peñas, P.; Filippelli, M.; Gibbons, A.; Grant, T.; Guilbault, S.; Gulliver, S.; Harris, C; Harvent, C.; Houston, K.; Kirby, J.S.; Matusiak, L.; Mehdizadeh, A.; Mojica, T.; Okun, M.; Orgill, D.; Pallack, L.; Parks-Miller, A.; Prens, E.P.; Randell, S.; Rogers, C.; Rosen, C.F.; Choon, S.E.; van der Zee, H.H.; Christensen, R.; Jemec, G.B.E.

2018-01-01

Summary Background A core outcomes set (COS) is an agreed minimum set of outcomes that should be measured and reported in all clinical trials for a specific condition. Hidradenitis suppurativa (HS) has no agreed-upon COS. A central aspect in the COS development process is to identify a set of candidate outcome domains from a long list of items. Our long list had been developed from patient interviews, a systematic review of the literature and a healthcare professional survey, and initial votes had been cast in two e-Delphi surveys. In this manuscript, we describe two in-person consensus meetings of Delphi participants designed to ensure an inclusive approach to generation of domains from related items. Objectives To consider which items from a long list of candidate items to exclude and which to cluster into outcome domains. Methods The study used an international and multistakeholder approach, involving patients, dermatologists, surgeons, the pharmaceutical industry and medical regulators. The study format was a combination of formal presentations, small group work based on nominal group theory and a subsequent online confirmation survey. Results Forty-one individuals from 13 countries and four continents participated. Nine items were excluded and there was consensus to propose seven domains: disease course, physical signs, HS-specific quality of life, satisfaction, symptoms, pain and global assessments. Conclusions The HISTORIC consensus meetings I and II will be followed by further e-Delphi rounds to finalize the core domain set, building on the work of the in-person consensus meetings. PMID:29080368

Achieving Consensus on Total Joint Replacement Trial Outcome Reporting Using the OMERACT Filter: Endorsement of the Final Core Domain Set for Total Hip and Total Knee Replacement Trials for Endstage Arthritis.

PubMed

Singh, Jasvinder A; Dowsey, Michelle M; Dohm, Michael; Goodman, Susan M; Leong, Amye L; Scholte Voshaar, Marieke M J H; Choong, Peter F

2017-11-01

Discussion and endorsement of the OMERACT total joint replacement (TJR) core domain set for total hip replacement (THR) and total knee replacement (TKR) for endstage arthritis; and next steps for selection of instruments. The OMERACT TJR working group met at the 2016 meeting at Whistler, British Columbia, Canada. We summarized the previous systematic reviews, the preliminary OMERACT TJR core domain set and results from previous surveys. We discussed preliminary core domains for TJR clinical trials, made modifications, and identified challenges with domain measurement. Working group participants (n = 26) reviewed, clarified, and endorsed each of the inner and middle circle domains and added a range of motion domain to the research agenda. TJR were limited to THR and TKR but included all endstage hip and knee arthritis refractory to medical treatment. Participants overwhelmingly endorsed identification and evaluation of top instruments mapping to the core domains (100%) and use of subscales of validated multidimensional instruments to measure core domains for the TJR clinical trial core measurement set (92%). An OMERACT core domain set for hip/knee TJR trials has been defined and we are selecting instruments to develop the TJR clinical trial core measurement set to serve as a common foundation for harmonizing measures in TJR clinical trials.

The 'Outcome Reporting in Brief Intervention Trials: Alcohol' (ORBITAL) framework: protocol to determine a core outcome set for efficacy and effectiveness trials of alcohol screening and brief intervention.

PubMed

Shorter, G W; Heather, N; Bray, Jeremy W; Giles, E L; Holloway, A; Barbosa, C; Berman, A H; O'Donnell, A J; Clarke, M; Stockdale, K J; Newbury-Birch, D

2017-12-22

The evidence base to assess the efficacy and effectiveness of alcohol brief interventions (ABI) is weakened by variation in the outcomes measured and by inconsistent reporting. The 'Outcome Reporting in Brief Intervention Trials: Alcohol' (ORBITAL) project aims to develop a core outcome set (COS) and reporting guidance for its use in future trials of ABI in a range of settings. An international Special Interest Group was convened through INEBRIA (International Network on Brief Interventions for Alcohol and Other Drugs) to inform the development of a COS for trials of ABI. ORBITAL will incorporate a systematic review to map outcomes used in efficacy and effectiveness trials of ABI and their measurement properties, using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) criteria. This will support a multi-round Delphi study to prioritise outcomes. Delphi panellists will be drawn from a range of settings and stakeholder groups, and the Delphi study will also be used to determine if a single COS is relevant for all settings. A consensus meeting with key stakeholder representation will determine the final COS and associated guidance for its use in trials of ABI. ORBITAL will develop a COS for alcohol screening and brief intervention trials, with outcomes stratified into domains and guidance on outcome measurement instruments. The standardisation of ABI outcomes and their measurement will support the ongoing development of ABI studies and a systematic synthesis of emerging research findings. We will track the extent to which the COS delivers on this promise through an exploration of the use of the guidance in the decade following COS publication.

The CROWN initiative: journal editors invite researchers to develop core outcomes in women’s health

PubMed Central

2014-01-01

Clinical trials, systematic reviews and guidelines compare beneficial and non-beneficial outcomes following interventions. Often, however, various studies on a particular topic do not address the same outcomes, making it difficult to draw clinically useful conclusions when a group of studies is looked at as a whole. This problem was recently thrown into sharp focus by a systematic review of interventions for preterm birth prevention, which found that among 103 randomised trials, no fewer than 72 different outcomes were reported. There is a growing recognition among clinical researchers that this variability undermines consistent synthesis of the evidence, and that what is needed is an agreed standardised collection of outcomes - a "core outcomes set" - for all trials in a specific clinical area. Recognising that the current inconsistency is a serious hindrance to progress in our specialty, the editors of over 50 journals related to women's health have come together to support The CROWN (CoRe Outcomes in WomeN's health) Initiative. PMID:25048583

The CROWN Initiative: journal editors invite researchers to develop core outcomes in women’s health

PubMed Central

2014-01-01

Clinical trials, systematic reviews and guidelines compare beneficial and non-beneficial outcomes following interventions. Often, however, various studies on a particular topic do not address the same outcomes, making it difficult to draw clinically useful conclusions when a group of studies is looked at as a whole. This problem was recently thrown into sharp focus by a systematic review of interventions for preterm birth prevention, which found that among 103 randomised trials, no fewer than 72 different outcomes were reported. There is a growing recognition among clinical researchers that this variability undermines consistent synthesis of the evidence, and that what is needed is an agreed standardised collection of outcomes - a "core outcomes set" - for all trials in a specific clinical area. Recognising that the current inconsistency is a serious hindrance to progress in our specialty, the editors of over 50 journals related to women's health have come together to support The CROWN (CoRe Outcomes in WomeN's health) Initiative. PMID:25050130

Standardising the reporting of outcomes in gastric cancer surgery trials: protocol for the development of a core outcome set and accompanying outcome measurement instrument set (the GASTROS study).

PubMed

Alkhaffaf, Bilal; Glenny, Anne-Marie; Blazeby, Jane M; Williamson, Paula; Bruce, Iain A

2017-08-09

Gastric cancer is one of the leading causes of cancer-related deaths worldwide. Whilst surgery is the mainstay of curative treatment, it is associated with significant risks. Surgical strategies for treating gastric cancer should be based on evidence from systematic reviews of well-designed randomised controlled trials. However, inconsistencies in the reporting of outcomes from these trials makes evidence synthesis unreliable. We present a protocol for an international consensus study to develop a standardised set of outcomes and measurement tools - a 'core outcome set' (COS) - to be used by all future trials examining therapeutic surgical interventions for gastric cancer. The GASTROS study aims to standardise the reporting of outcomes in gastric cancer surgery trials through an international consensus process of key stakeholders including health care professionals and patients. The first of three stages in the study will identify a 'long-list' of potentially important outcomes to be prioritised. These will be extracted from a systematic review of relevant academic literature and patient interviews. Stage 2 will comprise an eDelphi survey which will consider the views of patients, nurse specialists and surgeons to prioritise the most important outcomes. A meeting of stakeholder representatives will ratify the COS. Stage 3 will focus on identifying appropriate instruments to measure the prioritised outcomes by means of quality assessment of available measurement instruments and stakeholder consultation. This study aims to standardise the reporting of outcomes in future trials examining therapeutic surgical interventions for gastric cancer. It is anticipated that standardisation of outcome reporting in these surgical effectiveness trials will enhance the evidence base for clinical practice. Highlighting outcomes of greatest importance to patients will ensure that their perspectives are central to research in this field.

Patient-Oriented Eczema Measure (POEM), a core instrument to measure symptoms in clinical trials: a Harmonising Outcome Measures for Eczema (HOME) statement.

PubMed

Spuls, P I; Gerbens, L A A; Simpson, E; Apfelbacher, C J; Chalmers, J R; Thomas, K S; Prinsen, C A C; von Kobyletzki, L B; Singh, J A; Williams, H C; Schmitt, J

2017-04-01

The Harmonising Outcome Measures for Eczema (HOME) initiative has defined four core outcome domains for a core outcome set (COS) to be measured in all atopic eczema (AE) trials to ensure cross-trial comparison: clinical signs, symptoms, quality of life and long-term control. The aim of this paper is to report on the consensus process that was used to select the core instrument to consistently assess symptoms in all future AE trials. Following the HOME roadmap, two systematic reviews were performed which identified three instruments that had sufficient evidence of validity, reliability and feasibility to be considered for the final COS. At the fourth international HOME meeting, there was broad consensus among all stakeholders that the Patient-Oriented Eczema Measure (POEM) should be used as the core instrument (87·5% agreed, 9·4% unsure, 3·1% disagreed). All relevant stakeholders are encouraged to use POEM as the chosen instrument to measure the core domain of symptoms in all future AE clinical trials. Other instruments of interest can be used in addition to POEM. © 2016 British Association of Dermatologists.

Development of a core outcome set for clinical trials in inflammatory bowel disease: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey.

PubMed

Ma, Christopher; Panaccione, Remo; Fedorak, Richard N; Parker, Claire E; Khanna, Reena; Levesque, Barrett G; Sandborn, William J; Feagan, Brian G; Jairath, Vipul

2017-06-09

Crohn's disease (CD) and ulcerative colitis (UC), the main forms of inflammatory bowel disease (IBD), are chronic, progressive and disabling disorders of the gastrointestinal tract. Although data from randomised controlled trials (RCTs) provide the foundation of evidence that validates medical therapy for IBD, considerable heterogeneity exists in the measured outcomes used in these studies. Furthermore, in recent years, there has been a paradigm shift in IBD treatment targets, moving from symptom-based scoring to improvement or normalisation of objective measures of inflammation such as endoscopic appearance, inflammatory biomarkers and histological and radiographic end points. The abundance of new treatment options and evolving end points poses opportunities and challenges for all stakeholders involved in drug development. Accordingly, there exists a need to harmonise measures used in clinical trials through the development of a core outcome set (COS). The development of an IBD-specific COS includes four steps. First, a systematic literature review is performed to identify outcomes previously used in IBD RCTs. Second, semistructured qualitative interviews are conducted with key stakeholders, including patients, clinicians, researchers, pharmaceutical industry representatives, healthcare payers and regulators to identify additional outcomes of importance. Using the outcomes generated from literature review and stakeholder interviews, an international two-round Delphi survey is conducted to prioritise outcomes for inclusion in the COS. Finally, a consensus meeting is held to ratify the COS and disseminate findings for application in future IBD trials. Given that over 30 novel therapeutic compounds are in development for IBD treatment, the design of robust clinical trials measuring relevant and standardised outcomes is crucial. Standardising outcomes through a COS will reduce heterogeneity in trial reporting, facilitate valid comparisons of new therapies and improve clinical trial quality. © 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.

Multiple cores of Gleason score 6 correlate with favourable findings at radical prostatectomy

PubMed Central

Ellis, Carla L.; Walsh, Patrick C.; Partin, Alan W.; Epstein, Jonathan I.

2014-01-01

Objective To establish whether the good prognosis of Gleason score 6 (GS6) is maintained in the setting of multiple involved cores. Patients and Methods In total, 6156 men (from 1 April 2000 to 30 April 2007) with GS6 on biopsy underwent radical prostatectomy (RP) at our institution. The number of positive cores was correlated with the outcome at RP. Results More positive cores correlated with less organ-confined disease (P < 0.001), positive margins (P < 0.012), increasing RP grade (P < 0.001) and increased seminal vesicles/lymph node involvement (P = 0.012). For men with data available, the actuarial risk of being biochemically free of disease at 5 years was 93.2% when ≤6 cores were positive (812 men followed to 5 years) vs 89.1% if >6 cores were positive (41 men followed to 2 years) (P = 0.6). Although the predicted ‘cure rate’ of >75% probability of a tumour showing no evidence of biochemical recurrence at 10 years after RP was statistically different between cases with ≤6 vs >6 positive cores (P < 0.0001), the outcome in both groups was still favourable (90.5% vs 84%). Partin-like tables were generated factoring in the number of positive cores to predict organ-confined disease as a guide for urologists to perform nerve-sparing surgery. For example, with T1c disease, there was a ≥75% probability of organ-confined disease with one to three positive cores regardless of prostate-specific antigen (PSA) level, and the same probability was present with four to six positive cores and a PSA level of 0–4 ng/mL. Conclusion A low Gleason score on biopsy is a powerful prognostic finding, such that this favourable outcome is maintained even in the setting of multiple positive cores with GS6. PMID:23350787

Multiple cores of Gleason score 6 correlate with favourable findings at radical prostatectomy.

PubMed

Ellis, Carla L; Walsh, Patrick C; Partin, Alan W; Epstein, Jonathan I

2013-06-01

To establish whether the good prognosis of Gleason score 6 (GS6) is maintained in the setting of multiple involved cores. In total, 6156 men (from 1 April 2000 to 30 April 2007) with GS6 on biopsy underwent radical prostatectomy (RP) at our institution. The number of positive cores was correlated with the outcome at RP. More positive cores correlated with less organ-confined disease (P < 0.001), positive margins (P < 0.012), increasing RP grade (P < 0.001) and increased seminal vesicles/lymph node involvement (P = 0.012). For men with data available, the actuarial risk of being biochemically free of disease at 5 years was 93.2% when ≤6 cores were positive (812 men followed to 5 years) vs 89.1% if >6 cores were positive (41 men followed to 2 years) (P = 0.6). Although the predicted 'cure rate' of >75% probability of a tumour showing no evidence of biochemical recurrence at 10 years after RP was statistically different between cases with ≤6 vs >6 positive cores (P < 0.0001), the outcome in both groups was still favourable (90.5% vs 84%). Partin-like tables were generated factoring in the number of positive cores to predict organ-confined disease as a guide for urologists to perform nerve-sparing surgery. For example, with T1c disease, there was a ≥75% probability of organ-confined disease with one to three positive cores regardless of prostate-specific antigen (PSA) level, and the same probability was present with four to six positive cores and a PSA level of 0-4 ng/mL. A low Gleason score on biopsy is a powerful prognostic finding, such that this favourable outcome is maintained even in the setting of multiple positive cores with GS6. © 2013 BJU International.

Report from the OMERACT Hand Osteoarthritis Special Interest Group: advances and future research priorities.

PubMed

Kloppenburg, Margreet; Bøyesen, Pernille; Smeets, Wilma; Haugen, Ida K; Haugen, Ida; Liu, Rani; Visser, Willemien; van der Heijde, Désirée M

2014-04-01

Osteoarthritis (OA) is one of the most common musculoskeletal disorders, frequently affecting the hands. In the last decade there has been increased awareness concerning this disorder because of its clinical burden. Unfortunately, only limited treatments for symptom alleviation are available, and no effective treatment for disease modification exists. The lack of treatment is due not only to a lack of understanding of the disease process, but also to poor outcome measures to assess the condition. The OMERACT Hand OA Special Interest Group (SIG) has started to develop a core set of outcome measures for hand OA clinical trials, observational studies, and clinical record keeping. At OMERACT 11, results from a Delphi exercise were presented, and a preliminary set of core domains was discussed. The group attempted to adopt the new OMERACT Filter 2.0 in the process, and literature overviews of conventional radiographs, ultrasonography, and magnetic resonance imaging as outcome measures in hand OA were presented. Discussions that followed highlighted further suggestions for core domains, the heterogeneity of hand OA, and future research priorities.

International patient and physician consensus on a psoriatic arthritis core outcome set for clinical trials.

PubMed

Orbai, Ana-Maria; de Wit, Maarten; Mease, Philip; Shea, Judy A; Gossec, Laure; Leung, Ying Ying; Tillett, William; Elmamoun, Musaab; Callis Duffin, Kristina; Campbell, Willemina; Christensen, Robin; Coates, Laura; Dures, Emma; Eder, Lihi; FitzGerald, Oliver; Gladman, Dafna; Goel, Niti; Grieb, Suzanne Dolwick; Hewlett, Sarah; Hoejgaard, Pil; Kalyoncu, Umut; Lindsay, Chris; McHugh, Neil; Shea, Bev; Steinkoenig, Ingrid; Strand, Vibeke; Ogdie, Alexis

2017-04-01

To identify a core set of domains (outcomes) to be measured in psoriatic arthritis (PsA) clinical trials that represent both patients' and physicians' priorities. We conducted (1) a systematic literature review (SLR) of domains assessed in PsA; (2) international focus groups to identify domains important to people with PsA; (3) two international surveys with patients and physicians to prioritise domains; (4) an international face-to-face meeting with patients and physicians using the nominal group technique method to agree on the most important domains; and (5) presentation and votes at the Outcome Measures in Rheumatology (OMERACT) conference in May 2016. All phases were performed in collaboration with patient research partners. We identified 39 unique domains through the SLR (24 domains) and international focus groups (34 domains). 50 patients and 75 physicians rated domain importance. During the March 2016 consensus meeting, 12 patients and 12 physicians agreed on 10 candidate domains. Then, 49 patients and 71 physicians rated these domains' importance. Five were important to >70% of both groups: musculoskeletal disease activity, skin disease activity, structural damage, pain and physical function. Fatigue and participation were important to >70% of patients. Patient global and systemic inflammation were important to >70% of physicians. The updated PsA core domain set endorsed by 90% of OMERACT 2016 participants includes musculoskeletal disease activity, skin disease activity, pain, patient global, physical function, health-related quality of life, fatigue and systemic inflammation. The updated PsA core domain set incorporates patients' and physicians' priorities and evolving PsA research. Next steps include identifying outcome measures that adequately assess these domains. 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/.

The Need for Core Outcome Reporting in Autologous Fat Grafting for Breast Reconstruction.

PubMed

Agha, Riaz A; Fowler, Alexander J; Pidgeon, Thomas E; Wellstead, Georgina; Orgill, Dennis P

2016-11-01

There is growing interest in autologous fat grafting (AFG) for breast reconstruction. This systematic review examines the range of outcomes used across studies of AFG, their definitions and whether there is a need for a core outcome set to aid reporting. Following the protocol of our systematic review, a search of 20 databases (1986 to March 2014) returned 35 studies which met the inclusion criteria. These were assessed independently by two authors. Disagreements were resolved by consensus. Of the 35 studies, 27 (77%) were case series, 5 (14.3%) were cohort studies, and 3 (8.6%) were case reports. A total of 51 different outcomes were reported. These studies each reported a median of five separate outcomes (range, 2-14), of which a median of 3 outcomes were defined (range, 0-14). A median of 2 outcomes per paper were prespecified in the study methods (range, 0-12) and a median of only 2 outcomes per paper (range, 0-12) were both defined and prespecified. The most commonly reported outcome in studies of AFG was that of "operative details," reported by 26 studies, and eight different outcome definitions were used. "Cancer recurrence" was reported by 20 studies, with the use of 10 different outcome definitions. Overall, there was a poor proportion of defined and prespecified outcomes that employed a wide range of different outcome definitions. In addition only 14/35 studies stated the number of patients lost to follow-up. There is a need for a core outcomes set for AFG to the breast to minimise outcome and reporting bias and aid evidence synthesis. Our future research will focus in this direction, titled VOGUE or Valid Outcomes for the Grafting of AUtologous Fat to the BrEast study. We invite all those interested to get in touch with the lead author.

Are dental researchers asking patient-important questions? A scoping review.

PubMed

Fleming, Padhraig S; Koletsi, Despina; O'Brien, Kevin; Tsichlaki, Aliki; Pandis, Nikolaos

2016-06-01

There is an increasing recognition that research outcomes should resonate with patients rather than fixating on technical aspects of interventions. We aimed to assess the nature of outcomes within a representative subset of clinical trials published in leading dental journals. Randomized controlled trials published over a 3-year period up to December 31st, 2015 were identified in eight leading general and specialty dental journals: Journal of Dental Research, Journal of Dentistry, American Journal of Orthodontics and Dentofacial Orthopedics, Pediatric Dentistry, International Journal of Prosthodontics, Journal of Endodontics, International Journal of Oral and Maxillofacial Surgery and Journal of Clinical Periodontology. The number and nature of outcomes considered within these trials were assessed. Overall 220 RCTs involving 409 outcomes (257 primary and 152 secondary) were identified. Measures of disease activity were most commonly assessed as both primary (n=91, 35%) and secondary outcomes (n=59, 39%). Quality of life and functional measures were rarely considered as primary outcome domains. Overall, 182 (44%) outcomes were primarily clinician-focused, 140 (34%) were patient-centered, while 22% (n=87) were both patient- and clinician- focused. There is an undue emphasis on technical, clinician-centered outcomes within dental research common to all specialty areas. Development and adoption of core outcome sets representing the minimum set of data that should be obtained within a dental clinical trial would assist in addressing this issue. There is an acceptance that research outcomes should ultimately be of relevance and benefit to patients rather than focusing on technical aspects of interventions. This study points to an undue emphasis on technical, clinician-centered outcomes within dental research common to all specialty areas. Development and adoption of agreed dental core outcome sets would help to remedy this. Copyright © 2016 Elsevier Ltd. All rights reserved.

Core Domains for Clinical Research in Acute Respiratory Failure Survivors: An International Modified Delphi Consensus Study.

PubMed

Turnbull, Alison E; Sepulveda, Kristin A; Dinglas, Victor D; Chessare, Caroline M; Bingham, Clifton O; Needham, Dale M

2017-06-01

To identify the "core domains" (i.e., patient outcomes, health-related conditions, or aspects of health) that relevant stakeholders agree are essential to assess in all clinical research studies evaluating the outcomes of acute respiratory failure survivors after hospital discharge. A two-round consensus process, using a modified Delphi methodology, with participants from 16 countries, including patient and caregiver representatives. Prior to voting, participants were asked to review 1) results from surveys of clinical researchers, acute respiratory failure survivors, and caregivers that rated the importance of 19 preliminary outcome domains and 2) results from a qualitative study of acute respiratory failure survivors' outcomes after hospital discharge, as related to the 19 preliminary outcome domains. Participants also were asked to suggest any additional potential domains for evaluation in the first Delphi survey. Web-based surveys of participants representing four stakeholder groups relevant to clinical research evaluating postdischarge outcomes of acute respiratory failure survivors: clinical researchers, clinicians, patients and caregivers, and U.S. federal research funding organizations. None. None. Survey response rates were 97% and 99% in round 1 and round 2, respectively. There were seven domains that met the a priori consensus criteria to be designated as core domains: physical function, cognition, mental health, survival, pulmonary function, pain, and muscle and/or nerve function. This study generated a consensus-based list of core domains that should be assessed in all clinical research studies evaluating acute respiratory failure survivors after hospital discharge. Identifying appropriate measurement instruments to assess these core domains is an important next step toward developing a set of core outcome measures for this field of research.

Towards core outcome set (COS) development: a follow-up descriptive survey of outcomes in Cochrane reviews.

PubMed

Wuytack, Francesca; Smith, Valerie; Clarke, Mike; Williamson, Paula; Gargon, Elizabeth

2015-05-19

A core outcome set (COS) can address problems of outcome heterogeneity and outcome reporting bias in trials and systematic reviews, including Cochrane reviews, helping to reduce waste. One of the aims of the international Core Outcome Measures in Effectiveness Trials (COMET) Initiative is to link the development and use of COS with the outcomes specified and reported in Cochrane reviews, including the outcomes listed in the summary of findings (SoF) tables. As part of this work, an earlier exploratory survey of the outcomes of newly published 2007 and 2011 Cochrane reviews was performed. This survey examined the use of COS, the variety of specified outcomes, and outcome reporting in Cochrane reviews by Cochrane Review Group (CRG). To examine changes over time and to explore outcomes that were repeatedly specified over time in Cochrane reviews by CRG, we conducted a follow-up survey of outcomes in 2013 Cochrane reviews. A descriptive survey of outcomes in Cochrane reviews that were first published in 2013. Outcomes specified in the methods sections and reported in the results section of the Cochrane reviews were examined by CRG. We also explored the uptake of SoF tables, the number of outcomes included in these, and the quality of the evidence for the outcomes. Across the 50 CRGs, 375 Cochrane reviews that included at least one study specified a total of 3142 outcomes. Of these outcomes, 32 % (1008) were not reported in the results section of these reviews. For 23 % (233) of these non-reported outcomes, we did not find any reason in the text of the review for this non-report. Fifty-seven percent (216/375) of reviews included a SoF table. The proportion of specified outcomes that were reported in Cochrane reviews had increased in 2013 (68 %) compared to 2007 (61 %) and 2011 (65 %). Importantly, 2013 Cochrane reviews that did not report specified outcomes were twice as likely to provide an explanation for why the outcome was not reported. There has been an increased uptake of SoF tables in Cochrane reviews. Outcomes that were repeatedly specified in Cochrane reviews by CRG in 2007, 2011, and 2013 may assist COS development.

Development of the International Classification of Functioning, Disability and Health core sets for bipolar disorders: results of an international consensus process.

PubMed

Ayuso-Mateos, José L; Avila, Carolina C; Anaya, Celia; Cieza, Alarcos; Vieta, Eduard

2013-01-01

The International Classification of Functioning, Disability and Health (ICF) is a tool of the World Health Organization (WHO) designed to be a guide to identify and classify relevant domains of human experience affected by health conditions. The purpose of this article is to describe the process for the development of two Core Sets for bipolar disorder (BD) in the framework of the ICF. The Comprehensive ICF Core Set for BD intends to be a guide for multidisciplinary assessment of patients diagnosed with this condition, while the Brief ICF Core Set for BD will be useful when rating aspects of patient's experience for clinical practice or epidemiological studies. An international consensus conference involving a sample of experts with different professional backgrounds was performed using the nominal group technique. Various preparatory studies identified a set of 743 potential ICF categories to be included in the Core Sets. A total of 38 ICF categories were selected to be included in the Comprehensive Core Set for BD. A total of 19 ICF categories from the Comprehensive Core Set were chosen as the most significant to constitute the Brief Core Set for BD. The formal consensus process integrating evidence and expert opinion on the ICF led to the formal adoption of the ICF Core Sets for BD. The most important categories included are representative of the characteristics usually associated with BD. The next phase of this ICF project is to conduct a formal validation process to establish its applicability in clinical settings. Implications for Rehabilitation Bipolar disorder (BD) is a prevalent condition that has a great impact on people who suffer it, not only in health but also in daily functioning and quality of life. No standard has been defined so far regarding the problems in functioning of persons with BDs. The process described in this article defines the set of areas of functioning to be addressed in clinical assessments of persons with BD and establish the starting point for the development of condition-specific outcome measures.

Preliminary definition of improvement in juvenile arthritis.

PubMed

Giannini, E H; Ruperto, N; Ravelli, A; Lovell, D J; Felson, D T; Martini, A

1997-07-01

To identify a core set of outcome variables for the assessment of children with juvenile arthritis (JA), to use the core set to develop a definition of improvement to determine whether individual patients demonstrate clinically important improvement, and to promote this definition as a single efficacy measure in JA clinical trials. A core set of outcome variables was established using a combination of statistical and consensus formation techniques. Variables in the core set consisted of 1) physician global assessment of disease activity; 2) parent/patient assessment of overall well-being; 3) functional ability; 4) number of joints with active arthritis; 5) number of joints with limited range of motion; and 6) erythrocyte sedimentation rate. To establish a definition of improvement using this core set, 21 pediatric rheumatologists from 14 countries met, and, using consensus formation techniques, scored each of 72 patient profiles as improved or not improved. Using the physicians' consensus as the gold standard, the chi-square, sensitivity, and specificity were calculated for each of 240 possible definitions of improvement. Definitions with sensitivity or specificity of <80% were eliminated. The ability of the remaining definitions to discriminate between the effects of active agent and those of placebo, using actual trial data, was then observed. Each definition was also ranked for face validity, and the sum of the ranks was then multiplied by the kappa statistic. The definition of improvement with the highest final score was as follows: at least 30% improvement from baseline in 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by >30%. The second highest scoring definition was closely related to the first; the third highest was similar to the Paulus criteria used in adult rheumatoid arthritis trials, except with different variables. This indicates convergent validity of the process used. We propose a definition of improvement for JA. Use of a uniform definition will help standardize the conduct and reporting of clinical trials, and should help practitioners decide if a child with JA has responded adequately to therapy. We are in the process of prospectively validating this definition and several others that scored highly.

Establishing core outcome sets for phenylketonuria (PKU) and medium-chain Acyl-CoA dehydrogenase (MCAD) deficiency in children: study protocol for systematic reviews and Delphi surveys.

PubMed

Potter, Beth K; Hutton, Brian; Clifford, Tammy J; Pallone, Nicole; Smith, Maureen; Stockler, Sylvia; Chakraborty, Pranesh; Barbeau, Pauline; Garritty, Chantelle M; Pugliese, Michael; Rahman, Alvi; Skidmore, Becky; Tessier, Laure; Tingley, Kylie; Coyle, Doug; Greenberg, Cheryl R; Korngut, Lawrence; MacKenzie, Alex; Mitchell, John J; Nicholls, Stuart; Offringa, Martin; Schulze, Andreas; Taljaard, Monica

2017-12-19

Inherited metabolic diseases (IMD) are a large group of rare single-gene disorders that are typically diagnosed early in life. There are important evidence gaps related to the comparative effectiveness of therapies for IMD, which are in part due to challenges in conducting randomized controlled trials (RCTs) for rare diseases. Registry-based RCTs present a unique opportunity to address these challenges provided the registries implement standardized collection of outcomes that are important to patients and their caregivers and to clinical providers and healthcare systems. Currently there is no core outcome set (COS) for studies evaluating interventions for paediatric IMD. This protocol outlines a study that will establish COS for each of two relatively common IMD in children, phenylketonuria (PKU) and medium-chain acyl-CoA dehydrogenase (MCAD) deficiency. This two-part study is registered with the Core Outcome Measures in Effectiveness Trials (COMET) initiative. Part 1 includes a rapid review and development of an evidence map to identify a comprehensive listing of outcomes reported in past studies of PKU and MCAD deficiency. The review follows established methods for knowledge synthesis, including a comprehensive search strategy, two stages of screening citations against inclusion/exclusion criteria by two reviewers working independently, and extraction of important data elements from eligible studies, including details of the outcomes collected and outcome measurement instruments. The review findings will inform part 2 of our study, a set of Delphi surveys to establish consensus on the highest priority outcomes for each condition. Healthcare providers, families of children with PKU or MCAD deficiency, and health system decision-makers will be invited to participate in two to three rounds of Delphi surveys. The design of the surveys will involve parents of children with IMD who are part of a family advisory forum. This protocol is a crucial step in developing the capacity to launch RCTs with meaningful outcomes that address comparative effectiveness questions in the field of paediatric IMD. Such trials will contribute high-quality evidence to inform decision-making by patients and their family members, clinicians, and policy-makers.

Capturing and missing the patient's story through outcome measures: A thematic comparison of patient-generated items in PSYCHLOPS with CORE-OM and PHQ-9.

PubMed

Sales, Célia Md; Neves, Inês Td; Alves, Paula G; Ashworth, Mark

2017-11-22

There is increasing interest in individualized patient-reported outcome measures (I-PROMS), where patients themselves indicate the specific problems they want to address in therapy and these problems are used as items within the outcome measurement tool. This paper examined the extent to which 279 items reported in an I-PROM (PSYCHLOPS) added qualitative information which was not captured by two well-established outcome measures (CORE-OM and PHQ-9). Comparison of items was only conducted for patients scoring above the "caseness" threshold on the standardized measures. 107 patients were participating in therapy within addiction and general psychiatric clinical settings. Almost every patient (95%) reported at least one item whose content was not covered by PHQ-9, and 71% reported at least one item not covered by CORE-OM. Results demonstrate the relevance of individualized outcome assessment for capturing data describing the issues of greatest concern to patients, as nomothetic measures do not always seem to capture the whole story. © 2017 The Authors Health Expectations Published by John Wiley & Sons Ltd.

Choosing important health outcomes for comparative effectiveness research: An updated systematic review and involvement of low and middle income countries.

PubMed

Davis, Katherine; Gorst, Sarah L; Harman, Nicola; Smith, Valerie; Gargon, Elizabeth; Altman, Douglas G; Blazeby, Jane M; Clarke, Mike; Tunis, Sean; Williamson, Paula R

2018-01-01

Core outcome sets (COS) comprise a minimum set of outcomes that should be measured and reported in all trials for a specific health condition. The COMET (Core Outcome Measures in Effectiveness Trials) Initiative maintains an up to date, publicly accessible online database of published and ongoing COS. An annual systematic review update is an important part of this process. This review employed the same, multifaceted approach that was used in the original review and the previous two updates. This approach has identified studies that sought to determine which outcomes/domains to measure in clinical trials of a specific condition. This update includes an analysis of the inclusion of participants from low and middle income countries (LMICs) as identified by the OECD, in these COS. Eighteen publications, relating to 15 new studies describing the development of 15 COS, were eligible for inclusion in the review. Results show an increase in the use of mixed methods, including Delphi surveys. Clinical experts remain the most common stakeholder group involved. Overall, only 16% of the 259 COS studies published up to the end of 2016 have included participants from LMICs. This review highlights opportunities for greater public participation in COS development and the involvement of stakeholders from a wider range of geographical settings, in particular LMICs.

Developing a core outcome set for infant colic for primary, secondary and tertiary care settings: a prospective study.

PubMed

Steutel, Nina F; Benninga, Marc A; Langendam, Miranda W; Korterink, Judith J; Indrio, Flavia; Szajewska, Hania; Tabbers, Merit M

2017-05-29

Infant colic (IC) is defined as recurrent and prolonged crying without an obvious cause or evidence of failure to thrive or illness. It is a common problem with a prevalence of 5%-25%. The unknown aetiology results in a wide variety in interventions and use of heterogeneous outcome measures across therapeutic trials. Our aim was to develop a core outcome set (COS) for IC to facilitate and improve evidence synthesis. Prospective study design; primary, secondary and tertiary care. The COS was developed using a modified Delphi technique. First, healthcare professionals (HCPs) and parents of infants with IC were asked to list up to five outcomes they considered relevant in the treatment of IC. Outcomes mentioned by >10% of participants were forwarded to a shortlist. In the second round, outcomes on this shortlist were rated and prioritised. The final COS was defined in a face-to-face expert meeting of paediatricians. F of invited stakeholders (133 HCPs and 55 parents of infants with IC) completed both Delphi rounds. Duration of crying, family stress, sleeping time of infant, quality of life (of family), discomfort of infant and hospital admission/duration were rated as most important outcomes in IC, framing the final COS. The use of this COS should serve as a minimum of outcomes to be measured and reported. This will benefit evidence synthesis, by enhancing homogeneity of outcomes, and enable evaluation of success in therapeutic trials on IC. Researchers are strongly encouraged to use this COS when setting up a clinical trial in primary, secondary and/or tertiary care or performing a systematic review on IC. © 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.

Core information set for oesophageal cancer surgery.

PubMed

Blazeby, J M; Macefield, R; Blencowe, N S; Jacobs, M; McNair, A G K; Sprangers, M; Brookes, S T

2015-07-01

Surgeons provide patients with information before surgery, although standards of information are lacking and practice varies. The development and use of a 'core information set' as baseline information before surgery may improve understanding. A core set is a minimum set of information to use in all consultations before a specific procedure. This study developed a core information set for oesophageal cancer surgery. Information was identified from the literature, observations of clinical consultations and patient interviews. This was integrated to create a questionnaire survey. Stakeholders (patients and professionals) were surveyed twice to assess views on importance of information from 'not essential' to 'absolutely essential' using Delphi methods. Items not meeting predefined criteria were discarded after each survey and the final retained items were voted on, in separate patient and professional stakeholder meetings, to agree the core set. Some 67 information items were identified initially from multiple sources. Survey response rates were 76·5 per cent (185 of 242) and 54·8 per cent (126 of 230) for patients and professionals respectively (first round), and over 83 per cent in both groups thereafter. Health professionals rated short-term clinical outcomes most highly (technical complications), whereas patients prioritized information related to long-term benefits. The consensus meetings agreed the final set, which consisted of: in-hospital milestones to recovery, rates of open-and-close surgery, in-hospital mortality, major complications (reoperation), milestones in recovery after discharge, longer-term eating and drinking and overall quality of life, and chances of survival. This study has established a core information set for surgery for oesophageal cancer. © 2015 BJS Society Ltd Published by John Wiley & Sons Ltd.

Three Principles to Improve Outcomes for Children and Families. Science to Policy and Practice

ERIC Educational Resources Information Center

Cohen, Steven D.

2017-01-01

The science of child development and the core capabilities of adults point to a set of "design principles" that policymakers and practitioners in many different sectors can use to improve outcomes for children and families. That is, to be maximally effective, policies and services should: (1) support responsive relationships for children…

Estimating a Preference-Based Index from the Clinical Outcomes in Routine Evaluation–Outcome Measure (CORE-OM)

PubMed Central

Brazier, John E.; Rowen, Donna; Barkham, Michael

2013-01-01

Background. The Clinical Outcomes in Routine Evaluation–Outcome Measure (CORE-OM) is used to evaluate the effectiveness of psychological therapies in people with common mental disorders. The objective of this study was to estimate a preference-based index for this population using CORE-6D, a health state classification system derived from the CORE-OM consisting of a 5-item emotional component and a physical item, and to demonstrate a novel method for generating states that are not orthogonal. Methods. Rasch analysis was used to identify 11 emotional health states from CORE-6D that were frequently observed in the study population and are, thus, plausible (in contrast, conventional statistical design might generate implausible states). Combined with the 3 response levels of the physical item of CORE-6D, they generate 33 plausible health states, 18 of which were selected for valuation. A valuation survey of 220 members of the public in South Yorkshire, United Kingdom, was undertaken using the time tradeoff (TTO) method. Regression analysis was subsequently used to predict values for all possible states described by CORE-6D. Results. A number of multivariate regression models were built to predict values for the 33 health states of CORE-6D, using the Rasch logit value of the emotional state and the response level of the physical item as independent variables. A cubic model with high predictive value (adjusted R2 = 0.990) was selected to predict TTO values for all 729 CORE-6D health states. Conclusion. The CORE-6D preference-based index will enable the assessment of cost-effectiveness of interventions for people with common mental disorders using existing and prospective CORE-OM data sets. The new method for generating states may be useful for other instruments with highly correlated dimensions. PMID:23178639

Classification of functioning and impairment: the development of ICF core sets for autism spectrum disorder.

PubMed

Bölte, Sven; de Schipper, Elles; Robison, John E; Wong, Virginia C N; Selb, Melissa; Singhal, Nidhi; de Vries, Petrus J; Zwaigenbaum, Lonnie

2014-02-01

Given the variability seen in Autism Spectrum Disorder (ASD), accurate quantification of functioning is vital to studying outcome and quality of life in affected individuals. The International Classification of Functioning, Disability and Health (ICF) provides a comprehensive, universally accepted framework for the description of health-related functioning. ICF Core Sets are shortlists of ICF categories that are selected to capture those aspects of functioning that are most relevant when describing a person with a specific condition. In this paper, the authors preview the process for developing ICF Core Sets for ASD, a collaboration with the World Health Organization and the ICF Research Branch. The ICF Children and Youth version (ICF-CY) was derived from the ICF and designed to capture the specific situation of the developing child. As ASD affects individuals throughout the life span, and the ICF-CY includes all ICF categories, the ICF-CY will be used in this project ("ICF(-CY)" from now on). The ICF(-CY) categories to be included in the ICF Core Sets for ASD will be determined at an ICF Core Set Consensus Conference, where evidence from four preparatory studies (a systematic review, an expert survey, a patient and caregiver qualitative study, and a clinical cross-sectional study) will be integrated. Comprehensive and Brief ICF Core Sets for ASD will be developed with the goal of providing useful standards for research and clinical practice and generating a common language for functioning and impairment in ASD in different areas of life and across the life span. © 2013 International Society for Autism Research, Wiley Periodicals, Inc.

A core outcome set for all types of cardiac surgery effectiveness trials: a study protocol for an international eDelphi survey to achieve consensus on what to measure and the subsequent selection of measurement instruments.

PubMed

Moza, A; Benstoem, C; Autschbach, R; Stoppe, C; Goetzenich, A

2015-12-02

Cardiovascular disease (CVD) is a major contributor to the burden of disease and the number one cause of death worldwide. From 1990 until today, more people died from coronary heart disease than from any other cause. CVD is regularly treated with minimally or non-minimally invasive off- or on-pump cardiothoracic surgery and several interventions related to the outcome of the surgical procedures have been evaluated in clinical trials, but heterogeneity in outcome reporting hinders comparison of interventions across trials and limits the ability of research synthesis. This problem is encountered with the introduction of core outcome sets (COSs), which should be measured and reported, as a minimum, in all clinical trials for a specific clinical field. This study protocol describes the methods used to develop a COS for all types of cardiac surgery effectiveness trials. We aim to reach consensus on what to measure in an international three-round eDelphi exercise involving adult patients in need or after cardiothoracic surgery, cardiothoracic surgeons, cardiologists, anaesthesiologists, nursing staff and researchers with expertise in this particular field of medical research. Subsequently, outcome measurement instruments (how to measure) will be determined. Recommendations on COS development given by the Core Outcome Measures in Effectiveness Trials (COMET) Initiative and the Outcome Measures in Rheumatology (OMERACT) Initiative were followed. The proposed COS aims to provide methodological guidance for future cardiothoracic surgical trials to ensure the comparability of effects of interventions across studies and enable research synthesis. This does not imply that primary outcomes should always and exclusively be those of the COS. However, to ensure the comparability of results across trials, the outcomes included in this COS should be considered for inclusion besides measuring trial-specific clinical endpoints.

Multiprofessional evaluation in clinical practice: establishing a core set of outcome measures for children with cerebral palsy.

PubMed

Mäenpää, Helena; Autti-Rämö, Ilona; Varho, Tarja; Forsten, Wivi; Haataja, Leena

2017-03-01

To develop a national consensus on outcome measures that define functional ability in children with cerebral palsy (CP) according to the International Classification of Functioning, Disability and Health (ICF) framework. The project started in 2008 in neuropaediatric units of two university hospitals and one outpatient clinic. Each professional group selected representatives to be knowledge brokers for their own specialty. Based on the evidence, expert opinion, and the ICF framework, multiprofessional teams selected the most valid measures used in clinical practice (2009-2010). Data from 269 children with CP were analysed, classified by the Gross Motor Function Classification System, Manual Ability Classification System, and Communication Function Classification System, and evaluated. The process aimed at improving and unifying clinical practice in Finland through a national consensus on the core set of measures. The selected measures were presented by professional groups, and consensus was reached on the recommended core set of measures to be used in all hospitals treating children with CP in Finland. A national consensus on relevant and feasible measures is essential for identifying differences in the effectiveness of local practices, and for conducting multisite intervention studies. This project showed that multiprofessional rehabilitation practices can be improved through respect for and inclusion of everyone involved. © 2016 Mac Keith Press.

Standardized Reporting of the Eczema Area and Severity Index (EASI) and the Patient-Oriented Eczema Measure (POEM): A Recommendation by the Harmonising Outcome Measures for Eczema (HOME) Initiative.

PubMed

Grinich, E; Schmitt, J; Küster, D; Spuls, P I; Williams, H C; Chalmers, J R; Thomas, K S; Apfelbacher, C; Prinsen, C A C; Furue, M; Stuart, B; Carter, B; Simpson, E

2018-05-10

Several organizations from multiple fields of medicine are setting standards for clinical research including protocol development, 1 harmonization of outcome reporting, 2 statistical analysis, 3 quality assessment 4 and reporting of findings. 1 Clinical research standardization facilitates the interpretation and synthesis of data, increases the usability of trial results for guideline groups and shared decision-making, and reduces selective outcome reporting bias. The mission of the Harmonising Outcome Measures for Eczema (HOME) initiative is to establish an agreed-upon core set of outcomes to be measured and reported in all clinical trials of atopic dermatitis (AD). This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

The ICF Core Sets for hearing loss--researcher perspective. Part I: Systematic review of outcome measures identified in audiological research.

PubMed

Granberg, Sarah; Dahlström, Jennie; Möller, Claes; Kähäri, Kim; Danermark, Berth

2014-02-01

To review the literature in order to identify outcome measures used in research on adults with hearing loss (HL) as part of the ICF Core Sets development project, and to describe study and population characteristics of the reviewed studies. A systematic review methodology was applied using multiple databases. A comprehensive search was conducted and two search pools were created, pool I and pool II. The study population included adults (≥ 18 years of age) with HL and oral language as the primary mode of communication. 122 studies were included. Outcome measures were distinguished by 'instrument type', and 10 types were identified. In total, 246 (pool I) and 122 (pool II) different measures were identified, and only approximately 20% were extracted twice or more. Most measures were related to speech recognition. Fifty-one different questionnaires were identified. Many studies used small sample sizes, and the sex of participants was not revealed in several studies. The low prevalence of identified measures reflects a lack of consensus regarding the optimal outcome measures to use in audiology. Reflections and discussions are made in relation to small sample sizes and the lack of sex differentiation/descriptions within the included articles.

The COMET Initiative database: progress and activities update (2015).

PubMed

Gargon, E; Williamson, P R; Altman, D G; Blazeby, J M; Tunis, S; Clarke, M

2017-02-03

This letter describes the substantial activity on the Core Outcome Measure in Effectiveness Trials (COMET) website in 2015, updating our earlier progress reports for the period from the launch of the COMET website and database in August 2011 to December 2014. As in previous years, 2015 saw further increases in the annual number of visits to the website, the number of pages viewed and the number of searches undertaken. The sustained growth in use of the website and database suggests that COMET is continuing to gain interest and prominence, and that the resources are useful to people interested in the development of core outcome sets.

Appraising the uptake and use of recommendations for a common outcome data set for clinical trials: a case study in fall injury prevention.

PubMed

Copsey, Bethan; Hopewell, Sally; Becker, Clemens; Cameron, Ian D; Lamb, Sarah E

2016-03-10

Many researchers and professional bodies are seeking consensus for core outcomes for clinical trials. The Prevention of Falls Network Europe (ProFaNE) developed a common outcome data set for fall injury prevention trials 10 years ago. This study assesses the impact of these recommendations. A systematic search (up to 16 January 2015) was performed using Web of Science, Scopus and PubMed for articles citing the ProFaNE recommendations. Randomised trials on fall prevention in older people were selected for further analysis. Data were extracted on study characteristics and adherence to the key domains recommended by the ProFaNE consensus: falls, fall injury, physical activity, psychological consequences and health-related quality of life. Details of non-recommended outcome measures used were also recorded. The ProFaNE recommendations were cited in a total of 464 published articles, of which 34 were randomised trials on fall prevention in older people. Only one study (3 %) reported on all core domains. Most of the trials reported on falls (n = 32/34, 94 %) as a core outcome measure. Most of the recommendations within the falls domain were well-followed. Around half of the trials reported on fall-related injury (n = 16/34, 47 %). However, none reported the number of radiologically confirmed peripheral fracture events, which is the recommended outcome measure for injury. The other key domains (quality of life, physical activity and psychological consequences) were less frequently reported on, with a lack of consistency in the outcome measures used. The ProFaNE recommendations had a limited effect on standardising the reporting of outcomes in randomised trials on fall injury prevention in older people during the search period. Authors of consensus guidelines should consider maximising buy-in by including a diversity of geographic areas and academic disciplines at the development stage and using a solid dissemination strategy.

A Core Outcome Set for the Benefits and Adverse Events of Bariatric and Metabolic Surgery: The BARIACT Project.

PubMed

Coulman, Karen D; Hopkins, James; Brookes, Sara T; Chalmers, Katy; Main, Barry; Owen-Smith, Amanda; Andrews, Robert C; Byrne, James; Donovan, Jenny L; Mazza, Graziella; Reeves, Barnaby C; Rogers, Chris A; Thompson, Janice L; Welbourn, Richard; Wordsworth, Sarah; Blazeby, Jane M

2016-11-01

Bariatric and metabolic surgery is used as a treatment for patients with severe and complex obesity. However, there is a need to improve outcome selection and reporting in bariatric surgery trials. A Core Outcome Set (COS), an agreed minimum set of outcomes reported in all studies of a specific condition, may achieve this. Here, we present the development of a COS for BARIAtric and metabolic surgery Clinical Trials-the BARIACT Study. Outcomes identified from systematic reviews and patient interviews informed a questionnaire survey. Patients and health professionals were surveyed three times and asked to rate the importance of each item on a 1-9 scale. Delphi methods provided anonymised feedback to participants. Items not meeting predefined criteria were discarded between rounds. Remaining items were discussed at consensus meetings, held separately with patients and professionals, where the COS was agreed. Data sources identified 2,990 outcomes, which were used to develop a 130-item questionnaire. Round 1 response rates were moderate but subsequently improved to above 75% for other rounds. After rounds 2 and 3, 81 and 14 items were discarded, respectively, leaving 35 items for discussion at consensus meetings. The final COS included nine items: "weight," "diabetes status," "cardiovascular risk," "overall quality of life (QOL)," "mortality," "technical complications of the specific operation," "any re-operation/re-intervention," "dysphagia/regurgitation," and "micronutrient status." The main limitation of this study was that it was based in the United Kingdom only. The COS is recommended to be used as a minimum in all trials of bariatric and metabolic surgery. Adoption of the COS will improve data synthesis and the value of research data. Future work will establish methods for the measurement of the outcomes in the COS.

Effectiveness of prepregnancy care for women with pregestational diabetes mellitus: protocol for a systematic review of the literature and identification of a core outcomes set using a Delphi survey.

PubMed

Egan, Aoife M; Smith, Valerie; Devane, Declan; Dunne, Fidelma P

2015-08-14

Women with pregnancy complicated by pregestational diabetes experience increased rates of adverse pregnancy outcomes. Prepregnancy care is the targeted support and additional care offered to those women who are planning pregnancy and is associated with improved outcomes. However, there is significant heterogeneity in the outcomes measured and reported in studies evaluating the effects of prepregnancy care, which makes meaningful comparison difficult. The aim of this article is to present a protocol for a study to develop a Core Outcome Set (COS) for trials and other studies evaluating the effectiveness of prepregnancy care for women with pregestational diabetes mellitus. This study will include a systematic review of the literature to identify outcomes that have previously been reported in studies evaluating prepregnancy care for women with pregestational diabetes. We will then prioritise these outcomes from the perspective of key stakeholders, including women with pregestational diabetes as well as clinicians, using a Delphi survey. A final consensus meeting will be held with stakeholders to review and finalise the outcomes. The expectation is that the COS will always be collected and reported in all clinical trials, audits of practice and other forms of research that involve prepregnancy care programs for women with pregestational diabetes. This will facilitate comparing and contrasting of studies and allow for combining of appropriate studies with the ultimate goal of improved patient care.

Outcomes of Grazing Impacts between Sub-Neptunes in Kepler  Multis

NASA Astrophysics Data System (ADS)

Hwang, Jason; Chatterjee, Sourav; Lombardi, James, Jr.; Steffen, Jason H.; Rasio, Frederic

2018-01-01

Studies of high-multiplicity, tightly packed planetary systems suggest that dynamical instabilities are common and affect both the orbits and planet structures, where the compact orbits and typically low densities make physical collisions likely outcomes. Since the structure of many of these planets is such that the mass is dominated by a rocky core, but the volume is dominated by a tenuous gas envelope, the sticky-sphere approximation, used in dynamical integrators, may be a poor model for these collisions. We perform five sets of collision calculations, including detailed hydrodynamics, sampling mass ratios, and core mass fractions typical in Kepler Multis. In our primary set of calculations, we use Kepler-36 as a nominal remnant system, as the two planets have a small dynamical separation and an extreme density ratio. We use an N-body code, Mercury 6.2, to integrate initially unstable systems and study the resultant collisions in detail. We use these collisions, focusing on grazing collisions, in combination with realistic planet models created using gas profiles from Modules for Experiments in Stellar Astrophysics and core profiles using equations of state from Seager et al. to perform hydrodynamic calculations, finding scatterings, mergers, and even a potential planet–planet binary. We dynamically integrate the remnant systems, examine the stability, and estimate the final densities, finding that the remnant densities are sensitive to the core masses, and collisions result in generally more stable systems. We provide prescriptions for predicting the outcomes and modeling the changes in mass and orbits following collisions for general use in dynamical integrators.

Current Status, Goals, and Research Agenda for Outcome Measures Development in Behçet Syndrome: Report from OMERACT 2014.

PubMed

Hatemi, Gulen; Ozguler, Yesim; Direskeneli, Haner; Mahr, Alfred; Gul, Ahmet; Levi, Virna; Aydin, Sibel Z; Mumcu, Gonca; Sertel-Berk, Ozlem; Stevens, Randall M; Yazici, Hasan; Merkel, Peter A

2015-12-01

There is an unmet need for reliable, validated, and widely accepted outcomes and outcome measures for use in clinical trials in Behçet syndrome (BS). Our report summarizes initial steps taken by the Outcome Measures in Rheumatology (OMERACT) vasculitis working group toward developing a core set of outcome measures for BS according to the OMERACT methodology, including the OMERACT Filter 2.0, and discussions during the first meeting of the BS working group held during OMERACT 12 (2014). During OMERACT 12, some of the important challenges in developing outcomes for BS were outlined and discussed, and a research agenda was drafted. Among topics discussed were the advantages and disadvantages of a composite measure for BS that evaluates several organs/organ systems; bringing patients and physicians together for discussions about how to assess disease activity; use of organ-specific measures developed for other diseases; and the inclusion of generic, disease-specific, or organ-specific measures. The importance of incorporating patients' perspectives, concerns, and ideas into outcome measure development was emphasized. The planned research agenda includes conducting a Delphi exercise among physicians from different specialties that are involved in the care of patients with BS and among patients with BS, with the aim of identifying candidate domains and subdomains to be assessed in randomized clinical trials of BS, and candidate items for a composite measure. The ultimate goal of the group is to develop a validated and widely accepted core set of outcomes and outcome measures for use in clinical trials in BS.

Current Status, Goals, and Research Agenda for Outcome Measures Development in Behçet Syndrome: Report from OMERACT 2014

PubMed Central

Hatemi, Gulen; Ozguler, Yesim; Direskeneli, Haner; Mahr, Alfred; Gul, Ahmet; Levi, Virna; Aydin, Sibel Z.; Mumcu, Gonca; Sertel-Berk, Ozlem; Stevens, Randall M.; Yazici, Hasan; Merkel, Peter A.

2016-01-01

Objective There is an unmet need for reliable, validated, and widely accepted outcomes and outcome measures for use in clinical trials in Behçet syndrome (BS). Our report summarizes initial steps taken by the Outcome Measures in Rheumatology (OMERACT) vasculitis working group toward developing a core set of outcome measures for BS according to the OMERACT methodology, including the OMERACT Filter 2.0, and discussions during the first meeting of the BS working group held during OMERACT 12 (2014). Methods During OMERACT 12, some of the important challenges in developing outcomes for BS were outlined and discussed, and a research agenda was drafted. Results Among topics discussed were the advantages and disadvantages of a composite measure for BS that evaluates several organs/organ systems; bringing patients and physicians together for discussions about how to assess disease activity; use of organ-specific measures developed for other diseases; and the inclusion of generic, disease-specific, or organ-specific measures. The importance of incorporating patients’ perspectives, concerns, and ideas into outcome measure development was emphasized. Conclusion The planned research agenda includes conducting a Delphi exercise among physicians from different specialties that are involved in the care of patients with BS and among patients with BS, with the aim of identifying candidate domains and subdomains to be assessed in randomized clinical trials of BS, and candidate items for a composite measure. The ultimate goal of the group is to develop a validated and widely accepted core set of outcomes and outcome measures for use in clinical trials in BS. PMID:26373563

The Importance of Integration of Stakeholder Views in Core Outcome Set Development: Otitis Media with Effusion in Children with Cleft Palate

PubMed Central

Harman, Nicola L.; Bruce, Iain A.; Kirkham, Jamie J.; Tierney, Stephanie; Callery, Peter; O'Brien, Kevin; Williamson, Paula R.

2015-01-01

Background Approximately 75% of children with cleft palate (CP) have Otitis Media with Effusion (OME) histories. Evidence for the effective management of OME in these children is lacking. The inconsistency in outcome measurement in previous studies has led to a call for the development of a Core Outcome Set (COS). Despite the increase in the number of published COS, involvement of patients in the COS development process, and methods to integrate the views of patients and health professionals, to date have been limited. Methods and Findings A list of outcomes measured in previous research was identified through reviewing the literature. Opinion on the importance of each of these outcomes was then sought from key stakeholders: Ear, Nose and Throat (ENT) surgeons, audiologists, cleft surgeons, speech and language therapists, specialist cleft nurses, psychologists, parents and children. The opinion of health professionals was sought in a three round Delphi survey where participants were asked to score each outcome using a bespoke online system. Parents and children were also asked to score outcomes in a survey and provided an in-depth insight into having OME through semi-structured interviews. The results of the Delphi survey, interviews and parent/patient survey were brought together in a final consensus meeting with representation from all stakeholders. A final set of eleven outcomes reached the definition of “consensus in” to form the recommended COS: hearing; chronic otitis media (COM); OME; receptive language skills; speech development; psycho social development; acute otitis media (AOM); cholesteatoma; side effects of treatment; listening skills; otalgia. Conclusions We have produced a recommendation about the outcomes that should be measured, as a minimum, in studies of the management of OME in children with CP. The development process included input from key stakeholders and used novel methodology to integrate the opinion of healthcare professionals, parents and children. PMID:26115172

The Importance of Integration of Stakeholder Views in Core Outcome Set Development: Otitis Media with Effusion in Children with Cleft Palate.

PubMed

Harman, Nicola L; Bruce, Iain A; Kirkham, Jamie J; Tierney, Stephanie; Callery, Peter; O'Brien, Kevin; Bennett, Alex M D; Chorbachi, Raouf; Hall, Per N; Harding-Bell, Anne; Parfect, Victoria H; Rumsey, Nichola; Sell, Debbie; Sharma, Ravi; Williamson, Paula R

2015-01-01

Approximately 75% of children with cleft palate (CP) have Otitis Media with Effusion (OME) histories. Evidence for the effective management of OME in these children is lacking. The inconsistency in outcome measurement in previous studies has led to a call for the development of a Core Outcome Set (COS). Despite the increase in the number of published COS, involvement of patients in the COS development process, and methods to integrate the views of patients and health professionals, to date have been limited. A list of outcomes measured in previous research was identified through reviewing the literature. Opinion on the importance of each of these outcomes was then sought from key stakeholders: Ear, Nose and Throat (ENT) surgeons, audiologists, cleft surgeons, speech and language therapists, specialist cleft nurses, psychologists, parents and children. The opinion of health professionals was sought in a three round Delphi survey where participants were asked to score each outcome using a bespoke online system. Parents and children were also asked to score outcomes in a survey and provided an in-depth insight into having OME through semi-structured interviews. The results of the Delphi survey, interviews and parent/patient survey were brought together in a final consensus meeting with representation from all stakeholders. A final set of eleven outcomes reached the definition of "consensus in" to form the recommended COS: hearing; chronic otitis media (COM); OME; receptive language skills; speech development; psycho social development; acute otitis media (AOM); cholesteatoma; side effects of treatment; listening skills; otalgia. We have produced a recommendation about the outcomes that should be measured, as a minimum, in studies of the management of OME in children with CP. The development process included input from key stakeholders and used novel methodology to integrate the opinion of healthcare professionals, parents and children.

THE ROLE OF AFFECTIVE EXPERIENCE IN WORK MOTIVATION

PubMed Central

SEO, MYEONG-GU; BARRETT, LISA FELDMAN; BARTUNEK, JEAN M.

2005-01-01

Based on psychological and neurobiological theories of core affective experience, we identify a set of direct and indirect paths through which affective feelings at work affect three dimensions of behavioral outcomes: direction, intensity, and persistence. First, affective experience may influence these behavioral outcomes indirectly by affecting goal level and goal commitment, as well as three key judgment components of work motivation: expectancy judgments, utility judgments, and progress judgments. Second, affective experience may also affect these behavioral outcomes directly. We discuss implications of our model. PMID:16871321

Core outcome measures for interventions to prevent or slow the progress of dementia for people living with mild to moderate dementia: Systematic review and consensus recommendations

PubMed Central

Groskreutz, Derek; Grinbergs-Saull, Anna; Howard, Rob; O’Brien, John T.; Mountain, Gail; Woods, Bob; Perneczky, Robert; McCleery, Jenny; Pickett, James; Challis, David; Charlesworth, Georgina; Featherstone, Katie; Jones, Roy; Schneider, Justine; Shepperd, Sasha; Thompson-Coon, Jo; Ballard, Clive; Burns, Alistair; Garrard, Peter; Kehoe, Patrick; Passmore, Peter; Robinson, Louise

2017-01-01

Background There are no disease-modifying treatments for dementia. There is also no consensus on disease modifying outcomes. We aimed to produce the first evidence-based consensus on core outcome measures for trials of disease modification in mild-to-moderate dementia. Methods and findings We defined disease-modification interventions as those aiming to change the underlying pathology. We systematically searched electronic databases and previous systematic reviews for published and ongoing trials of disease-modifying treatments in mild-to-moderate dementia. We included 149/22,918 of the references found; with 81 outcome measures from 125 trials. Trials involved participants with Alzheimer’s disease (AD) alone (n = 111), or AD and mild cognitive impairment (n = 8) and three vascular dementia. We divided outcomes by the domain measured (cognition, activities of daily living, biological markers, neuropsychiatric symptoms, quality of life, global). We calculated the number of trials and of participants using each outcome. We detailed psychometric properties of each outcome. We sought the views of people living with dementia and family carers in three cities through Alzheimer’s society focus groups. Attendees at a consensus conference (experts in dementia research, disease-modification and harmonisation measures) decided on the core set of outcomes using these results. Recommended core outcomes were cognition as the fundamental deficit in dementia and to indicate disease modification, serial structural MRIs. Cognition should be measured by Mini Mental State Examination or Alzheimer's Disease Assessment Scale-Cognitive Subscale. MRIs would be optional for patients. We also made recommendations for measuring important, but non-core domains which may not change despite disease modification. Limitations Most trials were about AD. Specific instruments may be superseded. We searched one database for psychometric properties. Interpretation This is the first review to identify the 81 outcome measures the research community uses for disease-modifying trials in mild-to-moderate dementia. Our recommendations will facilitate designing, comparing and meta-analysing disease modification trials in mild-to-moderate dementia, increasing their value. Trial registration PROSPERO no. CRD42015027346. PMID:28662127

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

Improving the relevance and consistency of outcomes in comparative effectiveness research.

PubMed

Tunis, Sean R; Clarke, Mike; Gorst, Sarah L; Gargon, Elizabeth; Blazeby, Jane M; Altman, Douglas G; Williamson, Paula R

2016-03-01

Policy makers have clearly indicated--through heavy investment in the Patient Centered Outcomes Research Institute--that reporting outcomes that are meaningful to patients is crucial for improvement in healthcare delivery and cost reduction. Better interpretation and generalizability of clinical research results that incorporate patient-centered outcomes research can be achieved by accelerating the development and uptake of core outcome sets (COS). COS provide a standardized minimum set of the outcomes that should be measured and reported in all clinical trials of a specific condition. The level of activity around COS has increased significantly over the past decade, with substantial progress in several clinical domains. However, there are many important clinical conditions for which high-quality COS have not been developed and there are limited resources and capacity with which to develop them. We believe that meaningful progress toward the goals behind the significant investments in patient-centered outcomes research and comparative effectiveness research will depend on a serious effort to address these issues.

Improving the relevance and consistency of outcomes in comparative effectiveness research

PubMed Central

Tunis, Sean R; Clarke, Mike; Gorst, Sarah L; Gargon, Elizabeth; Blazeby, Jane M; Altman, Douglas G; Williamson, Paula R

2016-01-01

Policy makers have clearly indicated – through heavy investment in the Patient Centered Outcomes Research Institute – that reporting outcomes that are meaningful to patients is crucial for improvement in healthcare delivery and cost reduction. Better interpretation and generalizability of clinical research results that incorporate patient-centered outcomes research can be achieved by accelerating the development and uptake of core outcome sets (COS). COS provide a standardized minimum set of the outcomes that should be measured and reported in all clinical trials of a specific condition. The level of activity around COS has increased significantly over the past decade, with substantial progress in several clinical domains. However, there are many important clinical conditions for which high-quality COS have not been developed and there are limited resources and capacity with which to develop them. We believe that meaningful progress toward the goals behind the significant investments in patient-centered outcomes research and comparative effectiveness research will depend on a serious effort to address these issues. PMID:26930385

Exploration, Development, and Validation of Patient-reported Outcomes in Antineutrophil Cytoplasmic Antibody–associated Vasculitis Using the OMERACT Process

PubMed Central

Robson, Joanna C.; Milman, Nataliya; Tomasson, Gunnar; Dawson, Jill; Cronholm, Peter F.; Kellom, Katherine; Shea, Judy; Ashdown, Susan; Boers, Maarten; Boonen, Annelies; Casey, George C.; Farrar, John T.; Gebhart, Don; Krischer, Jeffrey; Lanier, Georgia; McAlear, Carol A.; Peck, Jacqueline; Sreih, Antoine G.; Tugwell, Peter; Luqmani, Raashid A.; Merkel, Peter A.

2016-01-01

Objective Antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) is a group of linked multisystem life- and organ-threatening diseases. The Outcome Measures in Rheumatology (OMERACT) vasculitis working group has been at the forefront of outcome development in the field and has achieved OMERACT endorsement of a core set of outcomes for AAV. Patients with AAV report as important some manifestations of disease not routinely collected through physician-completed outcome tools; and they rate common manifestations differently from investigators. The core set includes the domain of patient-reported outcomes (PRO). However, PRO currently used in clinical trials of AAV do not fully characterize patients’ perspectives on their burden of disease. The OMERACT vasculitis working group is addressing the unmet needs for PRO in AAV. Methods Current activities of the working group include (1) evaluating the feasibility and construct validity of instruments within the PROMIS (Patient-Reported Outcome Measurement Information System) to record components of the disease experience among patients with AAV; (2) creating a disease-specific PRO measure for AAV; and (3) applying The International Classification of Functioning, Disability and Health to examine the scope of outcome measures used in AAV. Results The working group has developed a comprehensive research strategy, organized an investigative team, included patient research partners, obtained peer-reviewed funding, and is using a considerable research infrastructure to complete these interrelated projects to develop evidence-based validated outcome instruments that meet the OMERACT filter of truth, discrimination, and feasibility. Conclusion The OMERACT vasculitis working group is on schedule to achieve its goals of developing validated PRO for use in clinical trials of AAV. (First Release September 1 2015; J Rheumatol 2015;42:2204–9; doi:10.3899/jrheum.141143) PMID:26329344

Fair Package Assignment

NASA Astrophysics Data System (ADS)

Lahaie, Sébastien; Parkes, David C.

We consider the problem of fair allocation in the package assignment model, where a set of indivisible items, held by single seller, must be efficiently allocated to agents with quasi-linear utilities. A fair assignment is one that is efficient and envy-free. We consider a model where bidders have superadditive valuations, meaning that items are pure complements. Our central result is that core outcomes are fair and even coalition-fair over this domain, while fair distributions may not even exist for general valuations. Of relevance to auction design, we also establish that the core is equivalent to the set of anonymous-price competitive equilibria, and that superadditive valuations are a maximal domain that guarantees the existence of anonymous-price competitive equilibrium. Our results are analogs of core equivalence results for linear prices in the standard assignment model, and for nonlinear, non-anonymous prices in the package assignment model with general valuations.

The Harmonising Outcome Measures for Eczema (HOME) statement to assess clinical signs of atopic eczema in trials.

PubMed

Schmitt, Jochen; Spuls, Phyllis I; Thomas, Kim S; Simpson, Eric; Furue, Masutaka; Deckert, Stefanie; Dohil, Magdalene; Apfelbacher, Christian; Singh, Jasvinder A; Chalmers, Joanne; Williams, Hywel C

2014-10-01

The lack of core outcome sets for atopic eczema (AE) is a major obstacle for advancing evidence-based treatment. The global Harmonising Outcome Measures for Eczema (HOME) initiative has already defined clinical signs, symptoms, quality of life, and long-term control of flares as core outcome domains for AE trials. This article deals with the standardization of measurement instruments to assess clinical signs of AE. To resolve the current lack of standardization of the assessment of clinical signs of AE, we followed a structured process of systematic reviews and international consensus sessions to identify 1 core outcome measurement instrument for assessment of clinical signs in all future AE trials. Systematic reviews indicated that from 16 different instruments identified to assess clinical signs of AE, only the Eczema Area and Severity Index (EASI) and the objective Scoring Atopic Dermatitis (SCORAD) index were identified as extensively validated. The EASI has adequate validity, responsiveness, internal consistency, and intraobserver reliability. The objective SCORAD index has adequate validity, responsiveness, and interobserver reliability but unclear intraobserver reliability to measure clinical signs of AE. In an international consensus study, patients, physicians, nurses, methodologists, and pharmaceutical industry representatives agreed that the EASI is the preferred core instrument to measure clinical signs in all future AE trials. All stakeholders involved in designing, reporting, and using clinical trials on AE are asked to comply with this consensus to enable better evidence-based decision making, clearer scientific communication, and improved patient care. Copyright © 2014 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

Examining the similarities and differences of OMERACT core sets using the ICF: first step towards an improved domain specification and development of an item pool to measure functioning and health.

PubMed

Escorpizo, Reuben; Boers, Maarten; Stucki, Gerold; Boonen, Annelies

2011-08-01

To contribute to the discussion on a common approach for domain selection in the Outcomes in Rheumatology Clinical Trials (OMERACT) process. First, this article reports on the consistency in the selection and names of the domains of the current OMERACT core set, and next on the comparability of the specifications of concepts that are relevant within the domains. For this purpose, a convenience sample of 4 OMERACT core sets was used: rheumatoid arthritis (RA), psoriatic arthritis (PsA), longitudinal observational studies (LOS) in rheumatology, and ankylosing spondylitis (AS). Domains from the different core sets were compared directly. To be able to compare the specific content of the domains, the concepts contained in the questionnaires that were considered or proposed to measure the domains were identified and linked to the category of the International Classification of Functioning, Disability, and Health (ICF) that best fit that construct. Large differences in the domains, and lack of domain definitions, were noted among the 4 OMERACT core sets. When comparing the concepts in the questionnaires that represent the domains, core sets differed also in the number and type of constructs that were addressed within each of the domains. Especially for the specification of the concepts within the domains Discomfort and Disability, the ICF proved to be useful as external reference to classify the different constructs. Our exercise suggests that the OMERACT process could benefit from a standardized approach to select, define, and specify domains, and demonstrated that the ICF is useful for further classification of the more specific concepts of "what to measure" within the domains. A clear definition and classification of domains and their specification can be useful as a starting point to build a pool of items that could then be used to develop new instruments to assess functioning and health for rheumatological conditions.

Development of a core outcome set for effectiveness trials aimed at optimising prescribing in older adults in care homes.

PubMed

Millar, Anna N; Daffu-O'Reilly, Amrit; Hughes, Carmel M; Alldred, David P; Barton, Garry; Bond, Christine M; Desborough, James A; Myint, Phyo K; Holland, Richard; Poland, Fiona M; Wright, David

2017-04-12

Prescribing medicines for older adults in care homes is known to be sub-optimal. Whilst trials testing interventions to optimise prescribing in this setting have been published, heterogeneity in outcome reporting has hindered comparison of interventions, thus limiting evidence synthesis. The aim of this study was to develop a core outcome set (COS), a list of outcomes which should be measured and reported, as a minimum, for all effectiveness trials involving optimising prescribing in care homes. The COS was developed as part of the Care Homes Independent Pharmacist Prescribing Study (CHIPPS). A long-list of outcomes was identified through a review of published literature and stakeholder input. Outcomes were reviewed and refined prior to entering a two-round online Delphi exercise and then distributed via a web link to the CHIPPS Management Team, a multidisciplinary team including pharmacists, doctors and Patient Public Involvement representatives (amongst others), who comprised the Delphi panel. The Delphi panellists (n = 19) rated the importance of outcomes on a 9-point Likert scale from 1 (not important) to 9 (critically important). Consensus for an outcome being included in the COS was defined as ≥70% participants scoring 7-9 and <15% scoring 1-3. Exclusion was defined as ≥70% scoring 1-3 and <15% 7-9. Individual and group scores were fed back to participants alongside the second questionnaire round, which included outcomes for which no consensus had been achieved. A long-list of 63 potential outcomes was identified. Refinement of this long-list of outcomes resulted in 29 outcomes, which were included in the Delphi questionnaire (round 1). Following both rounds of the Delphi exercise, 13 outcomes (organised into seven overarching domains: medication appropriateness, adverse drug events, prescribing errors, falls, quality of life, all-cause mortality and admissions to hospital (and associated costs)) met the criteria for inclusion in the final COS. We have developed a COS for effectiveness trials aimed at optimising prescribing in older adults in care homes using robust methodology. Widespread adoption of this COS will facilitate evidence synthesis between trials. Future work should focus on evaluating appropriate tools for these key outcomes to further reduce heterogeneity in outcome measurement in this context.

Psychometric properties of the Finnish version of the Young Person's Clinical Outcomes in Routine Evaluation (YP-CORE) questionnaire.

PubMed

Gergov, Vera; Lahti, Jari; Marttunen, Mauri; Lipsanen, Jari; Evans, Chris; Ranta, Klaus; Laitila, Aarno; Lindberg, Nina

2017-05-01

An increasing need exists for suitable measures to evaluate treatment outcome in adolescents. YP-CORE is a pan-theoretical brief questionnaire developed for this purpose, but it lacks studies in different cultures or languages. To explore the acceptability, factor structure, reliability, validity, and sensitivity to change of the Finnish translation of YP-CORE. The study was conducted at the Department of Adolescent Psychiatry, Helsinki University Central Hospital. A Finnish translation was prepared by a team of professionals and adolescents. A clinical sample of 104 patients was asked to complete the form together with BDI-21 and BAI, and 92 of them filled the forms again after a 3-month treatment. Analysis included acceptability, confirmatory factor analysis, internal and test-re-test reliability, concurrent validity, influence of gender and age, and criteria for reliable change. YP-CORE was well accepted, and the rate of missing values was low. Internal consistency (α = 0.83-.92) and test-re-test reliability were good (r = 0.69), and the results of CFA supported a one-factor model. YP-CORE showed good concurrent validity against two widely used symptom-specific measures (r = 0.62-0.87). Gender had a moderately strong effect on the scores (d = 0.67), but the effect of age was not as evident. The measure was sensitive to change, showing a larger effect size (d = 0.55) than in the BDI-21 and BAI (d = 0.31-0.50). The results show that the translation of YP-CORE into Finnish has been successful, the YP-CORE has good psychometric properties, and the measure could be taken into wider use in clinical settings for outcome measurement in adolescents.

Cases on Technology Integration in Mathematics Education

ERIC Educational Resources Information Center

Polly, Drew, Ed.

2015-01-01

Common Core education standards establish a clear set of specific ideas and skills that all students should be able to comprehend at each grade level. In an effort to meet these standards, educators are turning to technology for improved learning outcomes. "Cases on Technology Integration in Mathematics Education" provides a compilation…

2017 EULAR recommendations for a core data set to support observational research and clinical care in rheumatoid arthritis.

PubMed

Radner, Helga; Chatzidionysiou, Katerina; Nikiphorou, Elena; Gossec, Laure; Hyrich, Kimme L; Zabalan, Condruta; van Eijk-Hustings, Yvonne; Williamson, Paula R; Balanescu, Andra; Burmester, Gerd R; Carmona, Loreto; Dougados, Maxime; Finckh, Axel; Haugeberg, Glenn; Hetland, Merete Lund; Oliver, Susan; Porter, Duncan; Raza, Karim; Ryan, Patrick; Santos, Maria Jose; van der Helm-van Mil, Annette; van Riel, Piet; von Krause, Gabrielle; Zavada, Jakub; Dixon, William G; Askling, Johan

2018-04-01

Personalised medicine, new discoveries and studies on rare exposures or outcomes require large samples that are increasingly difficult for any single investigator to obtain. Collaborative work is limited by heterogeneities, both what is being collected and how it is defined. To develop a core set for data collection in rheumatoid arthritis (RA) research which (1) allows harmonisation of data collection in future observational studies, (2) acts as a common data model against which existing databases can be mapped and (3) serves as a template for standardised data collection in routine clinical practice to support generation of research-quality data. A multistep, international multistakeholder consensus process was carried out involving voting via online surveys and two face-to-face meetings. A core set of 21 items ('what to collect') and their instruments ('how to collect') was agreed: age, gender, disease duration, diagnosis of RA, body mass index, smoking, swollen/tender joints, patient/evaluator global, pain, quality of life, function, composite scores, acute phase reactants, serology, structural damage, treatment and comorbidities. The core set should facilitate collaborative research, allow for comparisons across studies and harmonise future data from clinical practice via electronic medical record systems. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Developing an OMERACT Core Outcome Set for Assessing Safety Components in Rheumatology Trials: The OMERACT Safety Working Group.

PubMed

Klokker, Louise; Tugwell, Peter; Furst, Daniel E; Devoe, Dan; Williamson, Paula; Terwee, Caroline B; Suarez-Almazor, Maria E; Strand, Vibeke; Woodworth, Thasia; Leong, Amye L; Goel, Niti; Boers, Maarten; Brooks, Peter M; Simon, Lee S; Christensen, Robin

2017-12-01

Failure to report harmful outcomes in clinical research can introduce bias favoring a potentially harmful intervention. While core outcome sets (COS) are available for benefits in randomized controlled trials in many rheumatic conditions, less attention has been paid to safety in such COS. The Outcome Measures in Rheumatology (OMERACT) Filter 2.0 emphasizes the importance of measuring harms. The Safety Working Group was reestablished at the OMERACT 2016 with the objective to develop a COS for assessing safety components in trials across rheumatologic conditions. The safety issue has previously been discussed at OMERACT, but without a consistent approach to ensure harms were included in COS. Our methods include (1) identifying harmful outcomes in trials of interventions studied in patients with rheumatic diseases by a systematic literature review, (2) identifying components of safety that should be measured in such trials by use of a patient-driven approach including qualitative data collection and statistical organization of data, and (3) developing a COS through consensus processes including everyone involved. Members of OMERACT including patients, clinicians, researchers, methodologists, and industry representatives reached consensus on the need to continue the efforts on developing a COS for safety in rheumatology trials. There was a general agreement about the need to identify safety-related outcomes that are meaningful to patients, framed in terms that patients consider relevant so that they will be able to make informed decisions. The OMERACT Safety Working Group will advance the work previously done within OMERACT using a new patient-driven approach.

Developing a virtual community for health sciences library book selection: Doody's Core Titles

PubMed Central

Shedlock, James; Walton, Linda J.

2006-01-01

Purpose: The purpose of this article is to describe Doody's Core Titles in the Health Sciences as a new selection guide and a virtual community based on an effective use of online systems and to describe its potential impact on library collection development. Setting/Participants/Resources: The setting is the availability of health sciences selection guides. Participants include Doody Enterprise staff, Doody's Library Board of Advisors, content specialists, and library selectors. Resources include the online system used to create Doody's Core Titles along with references to complementary databases. Brief Description: Doody's Core Titles is described and discussed in relation to the literature of selection guides, especially in comparison to the Brandon/Hill selected lists that were published from 1965 to 2003. Doody's Core Titles seeks to fill the vacuum created when the Brandon/Hill lists ceased publication. Doody's Core Titles is a unique selection guide based on its method of creating an online community of experts to identify and score a core list of titles in 119 health sciences specialties and disciplines. Results/Outcome: The result is a new selection guide, now available annually, that will aid health sciences librarians in identifying core titles for local collections. Evaluation Method: Doody's Core Titles organizes the evaluation of core titles that are identified and recommended by content specialists associated with Doody's Book Review Service and library selectors. A scoring mechanism is used to create the selection of core titles, similar to the star rating system employed in other Doody Enterprise products and services. PMID:16404471

A review of patient and carer participation and the use of qualitative research in the development of core outcome sets.

PubMed

Jones, Janet E; Jones, Laura L; Keeley, Thomas J H; Calvert, Melanie J; Mathers, Jonathan

2017-01-01

To be meaningful, a core outcome set (COS) should be relevant to all stakeholders including patients and carers. This review aimed to explore the methods by which patients and carers have been included as participants in COS development exercises and, in particular, the use and reporting of qualitative methods. In August 2015, a search of the Core Outcomes Measures in Effectiveness Trials (COMET) database was undertaken to identify papers involving patients and carers in COS development. Data were extracted to identify the data collection methods used in COS development, the number of health professionals, patients and carers participating in these, and the reported details of qualitative research undertaken. Fifty-nine papers reporting patient and carer participation were included in the review, ten of which reported using qualitative methods. Although patients and carers participated in outcome elicitation for inclusion in COS processes, health professionals tended to dominate the prioritisation exercises. Of the ten qualitative papers, only three were reported as a clear pre-designed part of a COS process. Qualitative data were collected using interviews, focus groups or a combination of these. None of the qualitative papers reported an underpinning methodological framework and details regarding data saturation, reflexivity and resource use associated with data collection were often poorly reported. Five papers reported difficulty in achieving a diverse sample of participants and two reported that a large and varied range of outcomes were often identified by participants making subsequent rating and ranking difficult. Consideration of the best way to include patients and carers throughout the COS development process is needed. Additionally, further work is required to assess the potential role of qualitative methods in COS, to explore the knowledge produced by different qualitative data collection methods, and to evaluate the time and resources required to incorporate qualitative methods into COS development.

A review of patient and carer participation and the use of qualitative research in the development of core outcome sets

PubMed Central

2017-01-01

Background To be meaningful, a core outcome set (COS) should be relevant to all stakeholders including patients and carers. This review aimed to explore the methods by which patients and carers have been included as participants in COS development exercises and, in particular, the use and reporting of qualitative methods. Methods In August 2015, a search of the Core Outcomes Measures in Effectiveness Trials (COMET) database was undertaken to identify papers involving patients and carers in COS development. Data were extracted to identify the data collection methods used in COS development, the number of health professionals, patients and carers participating in these, and the reported details of qualitative research undertaken. Results Fifty-nine papers reporting patient and carer participation were included in the review, ten of which reported using qualitative methods. Although patients and carers participated in outcome elicitation for inclusion in COS processes, health professionals tended to dominate the prioritisation exercises. Of the ten qualitative papers, only three were reported as a clear pre-designed part of a COS process. Qualitative data were collected using interviews, focus groups or a combination of these. None of the qualitative papers reported an underpinning methodological framework and details regarding data saturation, reflexivity and resource use associated with data collection were often poorly reported. Five papers reported difficulty in achieving a diverse sample of participants and two reported that a large and varied range of outcomes were often identified by participants making subsequent rating and ranking difficult. Conclusions Consideration of the best way to include patients and carers throughout the COS development process is needed. Additionally, further work is required to assess the potential role of qualitative methods in COS, to explore the knowledge produced by different qualitative data collection methods, and to evaluate the time and resources required to incorporate qualitative methods into COS development. PMID:28301485

Identification of ICF categories relevant for nursing in the situation of acute and early post-acute rehabilitation

PubMed Central

Mueller, Martin; Boldt, Christine; Grill, Eva; Strobl, Ralf; Stucki, Gerold

2008-01-01

Background The recovery of patients after an acute episode of illness or injury depends both on adequate medical treatment and on the early identification of needs for rehabilitation care. The process of early beginning rehabilitation requires efficient communication both between health professionals and the patient in order to effectively address all rehabilitation goals. The currently used nursing taxonomies, however, are not intended for interdisciplinary use and thus may not contribute to efficient rehabilitation management and an optimal patient outcome. The ICF might be the missing link in this communication process. The objective of this study was to identify the categories of the International Classification of Functioning, Disability and Health (ICF) categories relevant for nursing care in the situation of acute and early post-acute rehabilitation. Methods First, in a consensus process, "Leistungserfassung in der Pflege" (LEP) nursing interventions relevant for the situation of acute and early post-acute rehabilitation were selected. Second, in an integrated two-step linking process, two nursing experts derived goals of LEP nursing interventions from their practical knowledge and selected corresponding ICF categories most relevant for patients in acute and post-acute rehabilitation (ICF Core Sets). Results Eighty-seven percent of ICF Core Set categories could be linked to goals of at least one nursing intervention variable of LEP. The ICF categories most frequently linked with LEP nursing interventions were respiration functions, experience of self and time functions and focusing attention. Thirteen percent of ICF Core Set categories could not be linked with LEP nursing interventions. The LEP nursing interventions which were linked with the highest number of different ICF-categories of all were "therapeutic intervention", "patient-nurse communication/information giving" and "mobilising". Conclusion The ICF Core Sets for the acute hospital and early post-acute rehabilitation facilities are highly relevant for rehabilitation nursing. Linking nursing interventions with ICF Core Set categories is a feasible way to analyse nursing. Using the ICF Core Sets to describe goals of nursing interventions both facilitates inter-professional communication and respects patient's needs. The ICF may thus be a useful framework to set nursing intervention goals. PMID:18282288

American College of Rheumatology/European League against Rheumatism Preliminary Definition of Remission in Rheumatoid Arthritis for Clinical Trials

PubMed Central

Felson, David T.; Smolen, Josef S.; Wells, George; Zhang, Bin; van Tuyl, Lilian H. D.; Funovits, Julia; Aletaha, Daniel; Allaart, Renée; Bathon, Joan; Bombardieri, Stefano; Brooks, Peter; Brown, Andrew; Matucci-Cerinic, Marco; Choi, Hyon; Combe, Bernard; de Wit, Maarten; Dougados, Maxime; Emery, Paul; Furst, Dan; Gomez-Reino, Juan; Hawker , Gillian; Keystone, Edward; Khanna, Dinesh; Kirwan, John; Kvien, Tore; Landewé, Robert; Listing, Joachim; Michaud, Kaleb; Mola, Emilio Martin; Montie, Pam; Pincus, Ted; Richards, Pam; Siegel, Jeff; Simon, Lee; Sokka, Tuulikki; Strand, Vibeke; Tugwell, Peter; Tyndall, Alan; van der Heijde, Desirée; Verstappen, Suzan; White, Barbara; Wolfe, Fred; Zink, Angela; Boers, Maarten

2010-01-01

Background With remission in rheumatoid arthritis (RA) an increasingly attainable goal, there is no widely used definition of remission that is stringent but achievable and could be applied uniformly as an outcome in clinical trials. Methods A committee consisting of members of the American College of Rheumatology, the European League Against Rheumatism and the Outcome Measures in Rheumatology Initiative (OMERACT) met to guide the process and review prespecified analyses from clinical trials of patients with RA. The committee requested a stringent definition (little, if any, active disease) and decided to use core set measures to define remission including at least joint counts and an acute phase reactant. Members were surveyed to select the level of each core set measure consistent with remission. Candidate definitions of remission were tested including those that constituted a number of individual measures in remission (Boolean approach) as well as definitions using disease activity indexes. To select a definition of remission, trial data were analyzed to examine the added contribution of patient reported outcomes and the ability of candidate measures to predict later good x-ray and functional outcomes. Results Survey results for the definition of remission pointed to indexes at published thresholds and to a count of core set measures with each measure scored as 1 or less (e.g. tender and swollen joint counts, CRP and global assessments on 0-10 scale). Analyses suggested the need to include a patient reported measure. Examination of 2 year follow-up data suggested that many candidate definitions performed comparably in terms of predicting later good x-ray and functional outcomes, although DAS28 based measures of remission did not predict good radiographic outcomes as well as did the other candidate definitions. Given these and other considerations, we propose that a patient be defined as in remission based on one of two definitions : 1: When their scores on the following measures are all <1: tender joint count, swollen joint count, CRP (in mg/dL) and patient global assessment (0-10 scale), OR 2: when their score on the SDAI is < 3.3. Conclusion We propose two new definitions of remission both of which can be uniformly applied and widely used in RA clinical trials. We recommend that one of these be selected in each trial as an outcome and that the results on both be reported in each trial. PMID:21294106

American College of Rheumatology/European League against Rheumatism provisional definition of remission in rheumatoid arthritis for clinical trials.

PubMed

Felson, David T; Smolen, Josef S; Wells, George; Zhang, Bin; van Tuyl, Lilian H D; Funovits, Julia; Aletaha, Daniel; Allaart, Cornelia F; Bathon, Joan; Bombardieri, Stefano; Brooks, Peter; Brown, Andrew; Matucci-Cerinic, Marco; Choi, Hyon; Combe, Bernard; de Wit, Maarten; Dougados, Maxime; Emery, Paul; Furst, Daniel; Gomez-Reino, Juan; Hawker, Gillian; Keystone, Edward; Khanna, Dinesh; Kirwan, John; Kvien, Tore K; Landewé, Robert; Listing, Joachim; Michaud, Kaleb; Martin-Mola, Emilio; Montie, Pamela; Pincus, Theodore; Richards, Pamela; Siegel, Jeffrey N; Simon, Lee S; Sokka, Tuulikki; Strand, Vibeke; Tugwell, Peter; Tyndall, Alan; van der Heijde, Desirée; Verstappen, Suzan; White, Barbara; Wolfe, Frederick; Zink, Angela; Boers, Maarten

2011-03-01

Remission in rheumatoid arthritis (RA) is an increasingly attainable goal, but there is no widely used definition of remission that is stringent but achievable and could be applied uniformly as an outcome measure in clinical trials. This work was undertaken to develop such a definition. A committee consisting of members of the American College of Rheumatology, the European League Against Rheumatism, and the Outcome Measures in Rheumatology Initiative met to guide the process and review prespecified analyses from RA clinical trials. The committee requested a stringent definition (little, if any, active disease) and decided to use core set measures including, as a minimum, joint counts and levels of an acute-phase reactant to define remission. Members were surveyed to select the level of each core set measure that would be consistent with remission. Candidate definitions of remission were tested, including those that constituted a number of individual measures of remission (Boolean approach) as well as definitions using disease activity indexes. To select a definition of remission, trial data were analysed to examine the added contribution of patient-reported outcomes and the ability of candidate measures to predict later good radiographic and functional outcomes. Survey results for the definition of remission suggested indexes at published thresholds and a count of core set measures, with each measure scored as 1 or less (eg, tender and swollen joint counts, C reactive protein (CRP) level, and global assessments on a 0-10 scale). Analyses suggested the need to include a patient-reported measure. Examination of 2-year follow-up data suggested that many candidate definitions performed comparably in terms of predicting later good radiographic and functional outcomes, although 28-joint Disease Activity Score-based measures of remission did not predict good radiographic outcomes as well as the other candidate definitions did. Given these and other considerations, we propose that a patient's RA can be defined as being in remission based on one of two definitions: (1) when scores on the tender joint count, swollen joint count, CRP (in mg/dl), and patient global assessment (0-10 scale) are all ≤1, or (2) when the score on the Simplified Disease Activity Index is ≤3.3. We propose two new definitions of remission, both of which can be uniformly applied and widely used in RA clinical trials. The authors recommend that one of these be selected as an outcome measure in each trial and that the results on both be reported for each trial.

American College of Rheumatology/European League Against Rheumatism provisional definition of remission in rheumatoid arthritis for clinical trials.

PubMed

Felson, David T; Smolen, Josef S; Wells, George; Zhang, Bin; van Tuyl, Lilian H D; Funovits, Julia; Aletaha, Daniel; Allaart, Cornelia F; Bathon, Joan; Bombardieri, Stefano; Brooks, Peter; Brown, Andrew; Matucci-Cerinic, Marco; Choi, Hyon; Combe, Bernard; de Wit, Maarten; Dougados, Maxime; Emery, Paul; Furst, Daniel; Gomez-Reino, Juan; Hawker, Gillian; Keystone, Edward; Khanna, Dinesh; Kirwan, John; Kvien, Tore K; Landewé, Robert; Listing, Joachim; Michaud, Kaleb; Martin-Mola, Emilio; Montie, Pamela; Pincus, Theodore; Richards, Pamela; Siegel, Jeffrey N; Simon, Lee S; Sokka, Tuulikki; Strand, Vibeke; Tugwell, Peter; Tyndall, Alan; van der Heijde, Desirée; Verstappen, Suzan; White, Barbara; Wolfe, Frederick; Zink, Angela; Boers, Maarten

2011-03-01

Remission in rheumatoid arthritis (RA) is an increasingly attainable goal, but there is no widely used definition of remission that is stringent but achievable and could be applied uniformly as an outcome measure in clinical trials. This work was undertaken to develop such a definition. A committee consisting of members of the American College of Rheumatology, the European League Against Rheumatism, and the Outcome Measures in Rheumatology Initiative met to guide the process and review prespecified analyses from RA clinical trials. The committee requested a stringent definition (little, if any, active disease) and decided to use core set measures including, as a minimum, joint counts and levels of an acute-phase reactant to define remission. Members were surveyed to select the level of each core set measure that would be consistent with remission. Candidate definitions of remission were tested, including those that constituted a number of individual measures of remission (Boolean approach) as well as definitions using disease activity indexes. To select a definition of remission, trial data were analyzed to examine the added contribution of patient-reported outcomes and the ability of candidate measures to predict later good radiographic and functional outcomes. Survey results for the definition of remission suggested indexes at published thresholds and a count of core set measures, with each measure scored as 1 or less (e.g., tender and swollen joint counts, C-reactive protein [CRP] level, and global assessments on a 0-10 scale). Analyses suggested the need to include a patient-reported measure. Examination of 2-year followup data suggested that many candidate definitions performed comparably in terms of predicting later good radiographic and functional outcomes, although 28-joint Disease Activity Score-based measures of remission did not predict good radiographic outcomes as well as the other candidate definitions did. Given these and other considerations, we propose that a patient's RA can be defined as being in remission based on one of two definitions: (a) when scores on the tender joint count, swollen joint count, CRP (in mg/dl), and patient global assessment (0-10 scale) are all ≤ 1, or (b) when the score on the Simplified Disease Activity Index is ≤ 3.3. We propose two new definitions of remission, both of which can be uniformly applied and widely used in RA clinical trials. We recommend that one of these be selected as an outcome measure in each trial and that the results on both be reported for each trial. Copyright © 2011 by the American College of Rheumatology.

Reconciling healthcare professional and patient perspectives in the development of disease activity and response criteria in connective tissue disease-related interstitial lung diseases.

PubMed

Saketkoo, Lesley Ann; Mittoo, Shikha; Frankel, Sid; LeSage, Daphne; Sarver, Catherine; Phillips, Kristine; Strand, Vibeke; Matteson, Eric L

2014-04-01

Interstitial lung diseases (ILD), including those related to connective tissue disease (CTD), and idiopathic pulmonary fibrosis (IPF) carry high morbidity and mortality. Great efforts are under way to develop and investigate meaningful treatments in the context of clinical trials. However, efforts have been challenged by a lack of validated outcome measures and by inconsistent use of measures in clinical trials. Lack of consensus has fragmented effective use of strategies in CTD-ILD and IPF, with a history of resultant difficulties in obtaining agency approval of treatment interventions. Until recently, the patient perspective to determine domains and outcome measures in CTD-ILD and IPF had never been applied. Efforts described here demonstrate unequivocally the value and influence of patient involvement on core set development. Regarding CTD-ILD, this is the first OMERACT working group to directly address a manifestation/comorbidity of a rheumatic disease (ILD) as well as a disease not considered rheumatic (IPF). The OMERACT 11 proceedings of the CTD-ILD Working Group describe the forward and lateral process to include both the medical and patient perspectives in the urgently needed identification of a core set of preliminary domains and outcome measures in CTD-ILD and IPF.

Monitoring and Stimulating Development of Integrated Professional Skills in University Study Programmes

ERIC Educational Resources Information Center

Wahlgren, Marie; Ahlberg, Anders

2013-01-01

In Swedish higher education, quality assurance mainly focuses on course module outcomes. With this in mind we developed a qualitative method to monitor and stimulate progression of learning in two modularized engineering study programmes. A set of core professional values and skills were triangulated through interviews with students, teachers,…

A Review of Roles and Responsibilities: Restructuring for Excellence in the School System.

ERIC Educational Resources Information Center

Society for the Advancement of Excellence in Education, Kelowna (British Columbia).

Recommendations are presented for a new form of school governance in British Columbia that takes into account current research on effective schools. In the model described, the provincial government provides the funding, sets the core curriculum, standards, and outcomes, ensures standardized measurement and reporting, and supports field research.…

Childhood vaccination communication outcomes unpacked and organized in a taxonomy to facilitate core outcome establishment.

PubMed

Kaufman, Jessica; Ryan, Rebecca; Glenton, Claire; Lewin, Simon; Bosch-Capblanch, Xavier; Cartier, Yuri; Cliff, Julie; Oyo-Ita, Angela; Ames, Heather; Muloliwa, Artur Manuel; Oku, Afiong; Rada, Gabriel; Hill, Sophie

2017-04-01

We present a comprehensive taxonomy of outcomes for childhood vaccination communication interventions. Adding to our earlier map of trial outcomes, we aimed to (1) identify relevant outcomes not measured in trials, (2) identify outcomes from stakeholder focus groups, and (3) organize outcomes into a taxonomy. We identified additional outcomes from nonvaccination health communication literature and through parent and health care professional focus groups. We organized outcomes into the taxonomy through iterative discussion and informed by organizational principles established by leaders in core outcome research. The taxonomy includes three overarching core areas, divided into eight domains and then into outcomes. Core area one is psychosocial impact, including the domains "knowledge or understanding," "attitudes or beliefs," and "decision-making." Core area two is health impact, covering "vaccination status and behaviors" and "health status and well-being." Core area three is community, social, or health system impact, containing "intervention design and implementation," "community participation," and "resource use." To our knowledge, this taxonomy is the first attempt to conceptualize the range of potential outcomes for vaccination communication. It can be used by researchers selecting outcomes for complex communication interventions. We will also present the taxonomy to stakeholders to establish core outcome domains. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

International consensus on preliminary definitions of improvement in adult and juvenile myositis.

PubMed

Rider, Lisa G; Giannini, Edward H; Brunner, Hermine I; Ruperto, Nicola; James-Newton, Laura; Reed, Ann M; Lachenbruch, Peter A; Miller, Frederick W

2004-07-01

To use a core set of outcome measures to develop preliminary definitions of improvement for adult and juvenile myositis as composite end points for therapeutic trials. Twenty-nine experts in the assessment of myositis achieved consensus on 102 adult and 102 juvenile paper patient profiles as clinically improved or not improved. Two hundred twenty-seven candidate definitions of improvement were developed using the experts' consensus ratings as a gold standard and their judgment of clinically meaningful change in the core set of measures. Seventeen additional candidate definitions of improvement were developed from classification and regression tree analysis, a data-mining decision tree tool analysis. Six candidate definitions specifying percentage change or raw change in the core set of measures were developed using logistic regression analysis. Adult and pediatric working groups ranked the 13 top-performing candidate definitions for face validity, clinical sensibility, and ease of use, in which the sensitivity and specificity were >/=75% in adult, pediatric, and combined data sets. Nominal group technique was used to facilitate consensus formation. The definition of improvement (common to the adult and pediatric working groups) that ranked highest was 3 of any 6 of the core set measures improved by >/=20%, with no more than 2 worse by >/=25% (which could not include manual muscle testing to assess strength). Five and 4 additional preliminary definitions of improvement for adult and juvenile myositis, respectively, were also developed, with several definitions common to both groups. Participants also agreed to prospectively test 6 logistic regression definitions of improvement in clinical trials. Consensus preliminary definitions of improvement were developed for adult and juvenile myositis, and these incorporate clinically meaningful change in all myositis core set measures in a composite end point. These definitions require prospective validation, but they are now proposed for use as end points in all myositis trials.

Development of a core outcome set to determine the overall treatment success of acute uncomplicated appendicitis in children: a study protocol.

PubMed

Sherratt, Frances C; Eaton, Simon; Walker, Erin; Beasant, Lucy; Blazeby, Jane M; Young, Bridget; Crawley, Esther; Wood, Wendy W; Hall, Nigel J

2017-01-01

In recent years, there has been growing interest in alternatives to appendicectomy. In particular, non-operative treatment of appendicitis, with antibiotics alone, has been proposed as a potential treatment. A small number of randomised controlled trials (RCTs) in adults and, more recently, children suggest that antibiotic treatment may be a valid alternative to appendicectomy. However, there is currently insufficient data to justify its widespread use. Prior to performing further efficacy studies of the treatment of appendicitis in children, it is imperative to identify the most relevant outcome measures for inclusion in the design of comparative studies. This is of particular importance when evaluating a novel treatment approach since the outcomes of importance may differ from those commonly reported with traditional therapies.A review of the relevant literature and electronic resources failed to identify a core outcome set (COS) for children with appendicitis. We aim to define a COS for the measurement of treatment interventions in children (<18 years) with acute appendicitis. This project will entail: (1) a systematic review to identify previously reported acute uncomplicated appendicitis treatment outcomes; (2) assembly of stakeholder panels (paediatric and adult surgeons, patients and parents); (3) a three-stage Delphi process; and (4) a final consensus meeting to complete the COS. COS development is part of CONservative TReatment of Appendicitis in Children - a randomised controlled Trial (Feasibility) (CONTRACT) study, for which full ethical approval for CONTRACT has been granted. The COS development study is registered with the COMET Initiative in May 2017 (http://www.comet-initiative.org/studies/details/987).

Fibromyalgia Syndrome Module at OMERACT 9

PubMed Central

Mease, Philip; Arnold, Lesley M; Choy, Ernest H; Clauw, Daniel J.; Crofford, Leslie; Glass, Jennifer M; Martin, Susan A; Morea, Jessica; Simon, Lee; Strand, Vibeke; Williams, David A

2012-01-01

Objectives (1) Establish a core domain set for fibromyalgia (FM) assessment in clinical trials and practice, (2) review outcome measures’ performance characteristics, (3) discuss development of a responder index for the assessment of FM in clinical trials, (4) review objective markers, (5) review the domain of cognitive dysfunction, (6) establish a research agenda for work regarding outcomes research. Methods (1) Results of univariate and multivariate analysis of 10 different FM clinical trials of four different drugs, mapping key domains identified in previously presented patient focus group: Delphi exercises and a clinician/researcher Delphi exercise, breakout discussions to vote on possible essential domains and reliable measures. (2) Updates presented regarding outcome measures’ status. (3) Presented update on objective markers to measure FM disease state. 4) The issue of cognitive dysfunction (dyscognition) in FM was reviewed. Results (1) Greater than 70% of OMERACT participants agreed that pain, tenderness, fatigue, patient global, multidimensional function and sleep disturbance domains should be measured in all FM clinical trials, dyscognition and depression in some trial, and domains of research interest include stiffness, anxiety, functional imaging, and cerebrospinal fluid biomarkers. (2) FM domains’ outcome measures have generally proven to be reliable, discriminative, and feasible. More sophisticated and comprehensive measures are in development, as is a responder index for FM. (3) Increasing number of objective markers are being developed for FM assessment. (4) Cognitive dysfunction assessment by self-assessed and applied outcome measures is being developed. Conclusions A multidimensional symptom core set is proposed for the evaluation of FM in clinical trials. There is ongoing research on improved measures of single domains and composite measures. PMID:19820221

Comparing contents of outcome measures in cerebral palsy using the International Classification of Functioning (ICF-CY): a systematic review.

PubMed

Schiariti, Veronica; Klassen, Anne F; Cieza, Alarcos; Sauve, Karen; O'Donnell, Maureen; Armstrong, Robert; Mâsse, Louise C

2014-01-01

The International Classification of Functioning children and youth version (ICF-CY) provides a universal framework for defining and classifying functioning and disability in children worldwide. To facilitate the application of the ICF in practice, ICF based-tools like the "ICF Core Sets" are being developed. In the context of the development of the ICF-CY Core Sets for children with Cerebral Palsy (CP), the aims of this study were as follows: to identify and compare the content of outcome measures used in studies of children with CP using the ICF-CY coding system; and to describe the most frequently addressed areas of functioning in those studies. We searched multiple databases likely to capture studies involving children with CP from January 1998 to March 2012. We included all English language articles that studied children aged 2-18 years and described an interventional or observational study. Constructs of the outcome measures identified in studies were linked to the ICF-CY by two trained professionals. We found 231 articles that described 238 outcome measures. The outcome measures contained 2193 concepts that were linked to the ICF-CY and covered 161 independent ICF-CY categories. Out of the 161 categories, 53 (33.5%) were related to body functions, 75 (46%) were related to activities/participation, 26 (16.1%) were related to environmental factors, and 7 (4.3%) were related to body structures. This systematic review provides information about content of measures that may guide researchers and clinicians in their selection of an outcome measure for use in a study and/or clinical practice with children with CP. Copyright © 2013 European Paediatric Neurology Society. Published by Elsevier Ltd. All rights reserved.

TREatment of ATopic eczema (TREAT) Registry Taskforce: protocol for an international Delphi exercise to identify a core set of domains and domain items for national atopic eczema registries.

PubMed

Gerbens, Louise A A; Boyce, Aaron E; Wall, Dmitri; Barbarot, Sebastien; de Booij, Richard J; Deleuran, Mette; Middelkamp-Hup, Maritza A; Roberts, Amanda; Vestergaard, Christian; Weidinger, Stephan; Apfelbacher, Christian J; Irvine, Alan D; Schmitt, Jochen; Williamson, Paula R; Spuls, Phyllis I; Flohr, Carsten

2017-02-27

Patients with moderate-to-severe atopic eczema (AE) often require photo- or systemic immunomodulatory therapies to induce disease remission and maintain long-term control. The current evidence to guide clinical management is small, despite the frequent and often off-label use of these treatments. Registries of patients on photo- and systemic immunomodulatory therapies could fill this gap, and the collection of a core set concerning these therapies in AE will allow direct comparisons across registries as well as data sharing and pooling. Using an eDelphi approach, the international TREatment of ATopic eczema (TREAT) Registry Taskforce aims to seek consensus between key stakeholders internationally on a core set of domains and domain items for AE patient registries with a research focus that collect data of children and adults on photo- and systemic immunomodulatory therapies. Participants from six stakeholder groups will be invited: doctors, nurses, non-clinical researchers, patients, as well as industry and regulatory body representatives. The eDelphi will comprise three sequential online rounds, requesting participants to rate the importance of each proposed domain and domain items. Participants will be able to add domains and domain items to the proposed list in round 1. A final consensus meeting will be held with representatives of each stakeholder group. Identifying a uniform core set of domains and domain items to be captured by AE patient registries will increase the utility of individual registries, and provide greater insight into the effectiveness, safety and cost-effectiveness of photo- and systemic immunomodulatory therapies to guide clinical management across dermatology centres and country borders. Not applicable. This eDelphi study was registered in the Core Outcome Measures for Effectiveness Trials (COMET) database.

Protocol for the development of a core domain set for hidradenitis suppurativa trial outcomes.

PubMed

Thorlacius, Linnea; Ingram, John R; Garg, Amit; Villumsen, Bente; Esmann, Solveig; Kirby, Joslyn S; Gottlieb, Alice B; Merola, Joseph F; Dellavalle, Robert; Christensen, Robin; Jemec, Gregor B E

2017-02-20

Randomised controlled trials (RCTs) should have well-defined primary and secondary outcomes to answer questions generated by the main hypotheses. However, for the chronic, inflammatory skin disease hidradenitis suppurativa (HS), the reported outcome measures are numerous and diverse. A recent systematic review found a total of 30 outcome measure instruments in 12 RCTs. This use of a broad range of outcome measures can increase difficulties in interpretation and comparison of results and may potentially obstruct appropriate evidence synthesis by causing reporting bias. One strategy for dealing with these problems is to develop a core outcome set (COS). A COS is a list of outcomes that are meant as mandatory and should be measured and reported in all clinical trials. The aim of this study is to develop a COS for the management of HS. An international steering group of researchers, clinicians and a patient research partner will guide the COS development. 6 stakeholder groups are involved: patients, dermatologists, surgeons, nurses, industry representatives and drug regulatory authorities. A 1:1 ratio of patients:healthcare professionals is aimed for. The initial list of candidate items will be obtained by combining three data sets: (1) a systematic review of the literature, (2) US and Danish qualitative interview studies involving patients with HS and (3) an online healthcare professional (HCP) item generation survey. To reach consensus on the COS, 4 anonymous online Delphi rounds are then planned together with 2 face-to-face consensus meetings (1 in Europe and 1 in the USA) to ensure global representation. The study will be performed according to the Helsinki declaration. All results from the study, including inconclusive or negative results, will be published in peer-reviewed indexed journals. The study will involve different stakeholder groups to ensure that the developed COS will be suitable and well accepted. 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/.

Overcoming roadblocks: current and emerging reimbursement strategies for integrated mental health services in primary care.

PubMed

O'Donnell, Allison N; Williams, Mark; Kilbourne, Amy M

2013-12-01

The Chronic Care Model (CCM) has been shown to improve medical and psychiatric outcomes for persons with mental disorders in primary care settings, and has been proposed as a model to integrate mental health care in the patient-centered medical home under healthcare reform. However, the CCM has not been widely implemented in primary care settings, primarily because of a lack of a comprehensive reimbursement strategy to compensate providers for day-to-day provision of its core components, including care management and provider decision support. Drawing upon the existing literature and regulatory guidelines, we provide a critical analysis of challenges and opportunities in reimbursing CCM components under the current fee-for-service system, and describe an emerging financial model involving bundled payments to support core CCM components to integrate mental health treatment into primary care settings. Ultimately, for the CCM to be used and sustained over time to integrate physical and mental health care, effective reimbursement models will need to be negotiated across payers and providers. Such payments should provide sufficient support for primary care providers to implement practice redesigns around core CCM components, including care management, measurement-based care, and mental health specialist consultation.

Meeting Tomorrow's Expectations: In Search of Core Competencies and Ways of Assessing Them

ERIC Educational Resources Information Center

Podolskiy, O. A.; Pogozhina, V. A.

2016-01-01

Today, experts agree that the level of cognitive development of modern young people affects the long-term life goals and outcomes that they set for themselves. During the course of numerous studies experts have identified such key competencies as problem solving, information literacy, and critical thinking. However, there are still many unanswered…

Cognitive Training for Children: Effects on Inductive Reasoning, Deductive Reasoning, and Mathematics Achievement in an Australian School Setting

ERIC Educational Resources Information Center

Barkl, Sophie; Porter, Amy; Ginns, Paul

2012-01-01

Inductive reasoning is a core cognitive process of fluid intelligence, predicting a variety of educational outcomes. The Cognitive Training for Children (CTC) program is an educational intervention designed to develop children's inductive reasoning skills, with previous investigations finding substantial effects of the program on both inductive…

Collaborativeness as the Core of Professional Learning Communities beyond Culture and Context: Evidence from Canada, Finland, and Israel

ERIC Educational Resources Information Center

Jäppinen, Aini-Kristiina; Leclerc, Martine; Tubin, Dorit

2016-01-01

Professional learning communities (PLC) have been widely accepted as effective with respect to good atmosphere, adequate leadership practices, and functional working practices. However, the outcomes for school improvement depend on case-specific issues. To identify less culturally and contextually bound issues in 3 PLC settings in Canada, Finland,…

A Vision for the Future of Counseling: The 20/20 "Principles for Unifying and Strengthening the Profession"

ERIC Educational Resources Information Center

Kaplan, David M.; Gladding, Samuel T.

2011-01-01

This article describes the development of the historic "Principles for Unifying and Strengthening the Profession." An outcome of the "20/20: A Vision for the Future of Counseling" initiative, this document delineates a core set of principles that unifies and advances the counseling profession. "Principles for Unifying and Strengthening the…

Core outcome measures for opioid abuse liability laboratory assessment studies in humans: IMMPACT recommendations

PubMed Central

Comer, Sandra D.; Zacny, James P.; Dworkin, Robert H.; Turk, Dennis C.; Bigelow, George E.; Foltin, Richard W.; Jasinski, Donald R.; Sellers, Edward M.; Adams, Edgar H.; Balster, Robert; Burke, Laurie B.; Cerny, Igor; Colucci, Robert D.; Cone, Edward; Cowan, Penney; Farrar, John T.; Haddox, J. David; Haythornthwaite, Jennifer A.; Hertz, Sharon; Jay, Gary W.; Johanson, Chris-Ellyn; Junor, Roderick; Katz, Nathaniel P.; Klein, Michael; Kopecky, Ernest A.; Leiderman, Deborah B.; McDermott, Michael P.; O’Brien, Charles; O’Connor, Alec B.; Palmer, Pamela P.; Raja, Srinivasa N.; Rappaport, Bob A.; Rauschkolb, Christine; Rowbotham, Michael C.; Sampaio, Cristina; Setnik, Beatrice; Sokolowska, Marta; Stauffer, Joseph W.; Walsh, Sharon L.

2012-01-01

A critical component in development of opioid analgesics is assessment of their abuse liability (AL). Standardization of approaches and measures used in assessing AL has the potential to facilitate comparisons across studies, research laboratories, and drugs. The goal of this report is to provide consensus recommendations regarding core outcome measures for assessing abuse potential of opioid medications in humans in a controlled laboratory setting. Although many of the recommended measures are appropriate for assessing the AL of medications from other drug classes, the focus here is on opioid medications because they present unique risks from both physiological (e.g., respiratory depression, physical dependence) and public health (e.g., individuals in pain) perspectives. A brief historical perspective on AL testing is provided and then those measures that can be considered primary and secondary outcomes and possible additional outcomes in AL assessment are discussed. These outcome measures include: (1) subjective effects (some of which comprise the primary outcome measures, including drug liking); (2) physiological responses; (3) drug self-administration behavior; and (4) cognitive and psychomotor performance. Prior to presenting recommendations for standardized approaches and measures to be used in AL assessments, the appropriateness of using these measures in clinical trials with patients in pain is discussed. PMID:22998781

Anionic Pt in Silicate Melts at Low Oxygen Fugacity: Speciation, Partitioning and Implications for Core Formation Processes on Asteroids

NASA Technical Reports Server (NTRS)

Medard, E.; Martin, A. M.; Righter, K.; Malouta, A.; Lee, C.-T.

2017-01-01

Most siderophile element concentrations in planetary mantles can be explained by metal/ silicate equilibration at high temperature and pressure during core formation. Highly siderophile elements (HSE = Au, Re, and the Pt-group elements), however, usually have higher mantle abundances than predicted by partitioning models, suggesting that their concentrations have been set by late accretion of material that did not equilibrate with the core. The partitioning of HSE at the low oxygen fugacities relevant for core formation is however poorly constrained due to the lack of sufficient experimental constraints to describe the variations of partitioning with key variables like temperature, pressure, and oxygen fugacity. To better understand the relative roles of metal/silicate partitioning and late accretion, we performed a self-consistent set of experiments that parameterizes the influence of oxygen fugacity, temperature and melt composition on the partitioning of Pt, one of the HSE, between metal and silicate melts. The major outcome of this project is the fact that Pt dissolves in an anionic form in silicate melts, causing a dependence of partitioning on oxygen fugacity opposite to that reported in previous studies.

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/

Feasibility of comparing core data from existing trauma registries in scandinavia. Reaching for a Scandinavian major trauma outcome study (MTOS).

PubMed

Ringdal, K G; Lossius, H M

2007-01-01

The organisation of trauma care in Scandinavia has several similarities, including trauma registries, but so far there are limited amount of research on efficiency and outcome. Data and results from trauma outcome studies like the US MTOS are not fully applicable to the Scandinavian trauma population. To reveal the feasibility of using data from existing trauma registries of major hospitals in Scandinavia, for a minimal common dataset, in a joint, prospective Scandinavian MTOS. We collected data points, data point definitions, and inclusion/exclusion criteria, from the major trauma registries of the Swedish trauma registry standard, three university hospitals in Denmark, one university hospital in Finland, and the Norwegian National Trauma Registry. The collected material was compared to reveal common data points, inclusion criteria, and the compatibility of data point definitions. The median number of data points was 147 (range 71-257; interquartile range = 90-205). Most registries lacked precise data definition catalogues. Only 16 data points could be considered as common, of which just a few were core trauma data. Four data points had the same data category options but were not considered having the same data point definitions. The inclusion criteria were not uniform. Trauma registries in Scandinavia have few common core data and data point definitions. There were data points for calculating the Trauma and Injury Severity Score (TRISS) but the inclusion criteria varied too much to ensure a valid comparison. A consensus process for a joint trauma core data set will be initiated by the Scandinavian Networking Group for Trauma and Emergency Management (SCANTEM) to increase research on trauma efficiency and outcome.

Feasibility and Diagnostic Yield of Endoscopic Ultrasonography-Guided Fine Needle Biopsy With a New Core Biopsy Needle Device in Patients With Gastric Subepithelial Tumors

PubMed Central

Lee, Minju; Min, Byung-Hoon; Lee, Hyuk; Ahn, Sangjeong; Lee, Jun Haeng; Rhee, Poong-Lyul; Kim, Jae J.; Sohn, Tae Sung; Kim, Sung; Kim, Kyoung-Mee

2015-01-01

Abstract As treatment decisions for patients with gastric subepithelial tumors (SETs) largely depend on the histopathologic diagnosis, noninvasive and effective tissue acquisition methods are definitely required for proper management of gastric SETs. Recently, a new endoscopic ultrasonography-guided fine needle biopsy (EUS-FNB) device with ProCore reverse bevel technology was developed. We aimed to elucidate the feasibility and diagnostic yield of EUS-FNB with this new core biopsy needle device in patients with gastric SETs. A prospectively maintained database was retrospectively reviewed to identify consecutive patients who underwent EUS-FNB with a 22-gauge ProCore needle for gastric SETs 2 cm or larger. The main outcome measurement was the diagnostic yield of EUS-FNB. Procedure results were categorized into diagnostic, suggestive, or nondiagnostic. Of the 43 patients, needle punctures were successful in all cases irrespective of tumor location. EUS-FNB procedure results were diagnostic in 86.0%, suggestive in 4.7%, and nondiagnostic in 9.3% of cases, respectively. The diagnostic yield was the highest in fundus (100.0%), followed by body (89.5%), cardia (83.3%), and antrum (50.0%). All 18 patients with cardiac SET were finally diagnosed to have leiomyoma, and 16 patients with diagnostic or suggestive results avoided surgery. A heterogeneous echo pattern on EUS was found in 33.3% of cases with nondiagnostic or suggestive results and in 5.4% with diagnostic results. In multivariate analysis, no independent predictor of unsuccessful EUS-FNB with nondiagnostic or suggestive results was identified. Agreement between EUS-FNB and surgical pathology was 100% with respect to the diagnosis of gastrointestinal stromal tumor. However, there was a significant discrepancy in mitotic counts observed between the EUS-FNB and surgical specimens in patients with gastrointestinal stromal tumor. There were no significant procedure-related adverse events during and after the procedures. EUS-FNB with a 22G ProCore needle is a technically feasible, safe, and effective procedure for pathologic diagnosis of gastric SETs. This procedure can help refine surgical indications and facilitate a proper treatment decisions for gastric SETs, especially in the cardia. PMID:26448008

Nursing practice implications of the year of ethics.

PubMed

Harris, Karen T

2015-01-01

e 2015 ANA Code of Ethics is foundational to professional nursing practice and is aligned with AWHONN’s core values, standards of care and position statement on ethical decision-making in the clinical setting. Understanding the roles and responsibilities of nurses to ensure an ethical practice environment is critical to perinatal health outcomes and sta engagement and to the prevention of moral distress.

Toward a Global Consensus on Outcome Measures for Clinical Trials in Tinnitus: Report From the First International Meeting of the COMiT Initiative, November 14, 2014, Amsterdam, The Netherlands

PubMed Central

Haider, Haúla; Kikidis, Dimitris; Mielczarek, Marzena; Mazurek, Birgit; Szczepek, Agnieszka J.; Cederroth, Christopher R.

2015-01-01

In Europe alone, over 70 million people experience tinnitus; for seven million people, it creates a debilitating condition. Despite its enormous socioeconomic relevance, progress in successfully treating the condition is somewhat limited. The European Union has approved funding to create a pan-European tinnitus research collaboration network (2014–2018). The goal of one working group is to establish an international standard for outcome measurements in clinical trials of tinnitus. Importantly, this would enhance tinnitus research by informing sample-size calculations, enabling meta-analyses, and facilitating the identification of tinnitus subtypes, ultimately leading to improved treatments. The first meeting followed a workshop on “Agreed Standards for Measurement: An International Perspective” with invited talks on clinimetrics and existing international initiatives to define core sets for outcome measurements in hearing loss (International classification of functioning, disability, and health core sets for hearing loss) and eczema (Harmonizing outcome measures for eczema). Both initiatives have taken an approach that clearly distinguishes the specification of what to measure from that of how to measure it. Meeting delegates agreed on taking a step-wise roadmap for which the first output would be a consensus on what outcome domains are essential for all trials. The working group seeks to embrace inclusivity and brings together clinicians, tinnitus researchers, experts on clinical research methodology, statisticians, and representatives of the health industry. People who experience tinnitus are another important participant group. This meeting report is a call to those stakeholders across the globe to actively participate in the initiative. PMID:25910505

Toward a Global Consensus on Outcome Measures for Clinical Trials in Tinnitus: Report From the First International Meeting of the COMiT Initiative, November 14, 2014, Amsterdam, The Netherlands.

PubMed

Hall, Deborah A; Haider, Haúla; Kikidis, Dimitris; Mielczarek, Marzena; Mazurek, Birgit; Szczepek, Agnieszka J; Cederroth, Christopher R

2015-04-24

In Europe alone, over 70 million people experience tinnitus; for seven million people, it creates a debilitating condition. Despite its enormous socioeconomic relevance, progress in successfully treating the condition is somewhat limited. The European Union has approved funding to create a pan-European tinnitus research collaboration network (2014-2018). The goal of one working group is to establish an international standard for outcome measurements in clinical trials of tinnitus. Importantly, this would enhance tinnitus research by informing sample-size calculations, enabling meta-analyses, and facilitating the identification of tinnitus subtypes, ultimately leading to improved treatments. The first meeting followed a workshop on "Agreed Standards for Measurement: An International Perspective" with invited talks on clinimetrics and existing international initiatives to define core sets for outcome measurements in hearing loss (International classification of functioning, disability, and health core sets for hearing loss) and eczema (Harmonizing outcome measures for eczema). Both initiatives have taken an approach that clearly distinguishes the specification of what to measure from that of how to measure it. Meeting delegates agreed on taking a step-wise roadmap for which the first output would be a consensus on what outcome domains are essential for all trials. The working group seeks to embrace inclusivity and brings together clinicians, tinnitus researchers, experts on clinical research methodology, statisticians, and representatives of the health industry. People who experience tinnitus are another important participant group. This meeting report is a call to those stakeholders across the globe to actively participate in the initiative. © The Author(s) 2015.

Fibromyalgia syndrome module at OMERACT 9: domain construct.

PubMed

Mease, Philip; Arnold, Lesley M; Choy, Ernest H; Clauw, Daniel J; Crofford, Leslie J; Glass, Jennifer M; Martin, Susan A; Morea, Jessica; Simon, Lee; Strand, C Vibeke; Williams, David A

2009-10-01

The objective of the module was to (1) establish a core domain set for fibromyalgia (FM) assessment in clinical trials and practice, (2) review outcome measure performance characteristics, (3) discuss development of a responder index for assessment of FM in clinical trials, (4) review objective markers, (5) review the domain of cognitive dysfunction, and (6) establish a research agenda for outcomes research. Presentations at the module included: (1) Results of univariate and multivariate analysis of 10 FM clinical trials of 4 drugs, mapping key domains identified in previous patient focus group: Delphi exercises and a clinician/researcher Delphi exercise, and breakout discussions to vote on possible essential domains and reliable measures; (2) Updates regarding outcome measure status; (3) Update on objective markers to measure FM disease state; and (4) Review of the issue of cognitive dysfunction (dyscognition) in FM. Consensus was reached as follows: (1) Greater than 70% of OMERACT participants agreed that pain, tenderness, fatigue, patient global, multidimensional function and sleep disturbance domains should be measured in all FM clinical trials; dyscognition and depression should be measured in some trials; and stiffness, anxiety, functional imaging, and cerebrospinal fluid biomarkers were identified as domains of research interest. (2) FM domain outcome measures have generally proven to be reliable, discriminative, and feasible. More sophisticated and comprehensive measures are in development, as is a responder index for FM. (3) Increasing numbers of objective markers are being developed for FM assessment. (4) Cognitive dysfunction assessment by self-assessed and applied outcome measures is being developed. In conclusion, a multidimensional symptom core set is proposed for evaluation of FM in clinical trials. Research on improved measures of single domains and composite measures is ongoing.

A systematic review of measurement properties of patient reported outcome measures in psoriatic arthritis: A GRAPPA-OMERACT initiative.

PubMed

Højgaard, Pil; Klokker, Louise; Orbai, Ana-Maria; Holmsted, Kim; Bartels, Else M; Leung, Ying Ying; Goel, Niti; de Wit, Maarten; Gladman, Dafna D; Mease, Philip; Dreyer, Lene; Kristensen, Lars E; FitzGerald, Oliver; Tillett, William; Gossec, Laure; Helliwell, Philip; Strand, Vibeke; Ogdie, Alexis; Terwee, Caroline B; Christensen, Robin

2018-04-01

An updated psoriatic arthritis (PsA) core outcome set (COS) for randomized controlled trials (RCTs) was endorsed at the Outcome Measures in Rheumatology (OMERACT) meeting in 2016. To synthesize the evidence on measurement properties of patient reported outcome measures (PROMs) for PsA and thereby contribute to development of a PsA core outcome measurement set (COMS) as described by the OMERACT Filter 2.0. A systematic literature search was performed in EMBASE, MEDLINE and PsycINFO on Jan 1, 2017 to identify full-text articles with an aim of assessing the measurement properties of PROMs in PsA. Two independent reviewers rated the quality of studies using the COnsensus based standards for the Selection of health Measurement INstruments (COSMIN) checklist, and performed a qualitative evidence synthesis. Fifty-five studies were included in the systematic review. Forty-four instruments and a total of 89 scales were analyzed. PROMs measuring COS domains with at least fair quality evidence for good validity and reliability (and no evidence for poor properties) included the Stockerau Activity Score for PsA (German), Psoriasis Symptom Inventory, visual analogue scale for Patient Global, 36 Item Short Form Health Survey Physical Function subscale, Health Assessment Questionnaire Disability Index, Bath Ankylosing Spondylitis Functional Index, PsA Impact of Disease questionnaire, PsA Quality of Life questionnaire, VITACORA-19, Functional Assessment of Chronic Illness Therapy Fatigue scale and Social Role Participation Questionnaire. At least one PROM with some evidence for aspects of validity and reliability was available for six of the eight mandatory domains of the PsA COS. Copyright © 2018 Elsevier Inc. All rights reserved.

A taxonomy has been developed for outcomes in medical research to help improve knowledge discovery.

PubMed

Dodd, Susanna; Clarke, Mike; Becker, Lorne; Mavergames, Chris; Fish, Rebecca; Williamson, Paula R

2018-04-01

There is increasing recognition that insufficient attention has been paid to the choice of outcomes measured in clinical trials. The lack of a standardized outcome classification system results in inconsistencies due to ambiguity and variation in how outcomes are described across different studies. Being able to classify by outcome would increase efficiency in searching sources such as clinical trial registries, patient registries, the Cochrane Database of Systematic Reviews, and the Core Outcome Measures in Effectiveness Trials (COMET) database of core outcome sets (COS), thus aiding knowledge discovery. A literature review was carried out to determine existing outcome classification systems, none of which were sufficiently comprehensive or granular for classification of all potential outcomes from clinical trials. A new taxonomy for outcome classification was developed, and as proof of principle, outcomes extracted from all published COS in the COMET database, selected Cochrane reviews, and clinical trial registry entries were classified using this new system. Application of this new taxonomy to COS in the COMET database revealed that 274/299 (92%) COS include at least one physiological outcome, whereas only 177 (59%) include at least one measure of impact (global quality of life or some measure of functioning) and only 105 (35%) made reference to adverse events. This outcome taxonomy will be used to annotate outcomes included in COS within the COMET database and is currently being piloted for use in Cochrane Reviews within the Cochrane Linked Data Project. Wider implementation of this standard taxonomy in trial and systematic review databases and registries will further promote efficient searching, reporting, and classification of trial outcomes. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Comparison of rheumatoid arthritis clinical trial outcome measures: a simulation study.

PubMed

Anderson, Jennifer J; Bolognese, James A; Felson, David T

2003-11-01

Isolated studies have suggested that continuous measures of response may be better than predefined, dichotomous definitions (e.g., the American College of Rheumatology 20% improvement criteria [ACR20]) for discriminating between rheumatoid arthritis (RA) treatments. Our goal was to determine the statistical power of predefined dichotomous outcome measures (termed "a priori"), compared with that of continuous measures derived from trial data in which there was no predefined response threshold (termed "data driven"), and to evaluate the sensitivity to change of these measures in the context of different treatments and early versus later-stage disease. In order to generalize beyond results from a single trial, we performed simulation studies. We obtained summary data from trials comparing disease-modifying antirheumatic drugs (DMARDs) and from comparative coxib-placebo trials to test the power of 2 a priori outcomes, the ACR20 and improvement of the Disease Activity Score (DDAS), as well as 2 data-driven outcomes. We studied patients with early RA and those with later-stage RA (duration of <4 years and 4-9 years, respectively). We performed simulation studies, using the interrelationship of ACR core set measures in the trials to generate multiple trial data sets consistent with the original data. The data-driven outcomes had greater power than did the a priori measures. The DMARD comparison was more powerful in early disease than in later-stage disease (the sample sizes needed to achieve 80% power for the most powerful test were 64 for early disease versus 100 for later disease), but the coxib-versus-placebo comparison was less powerful in early disease than in later disease (the sample sizes needed to achieve 80% power were 200 and 100, respectively). When the effects of treatment on core set items were small and/or inconsistent, power was reduced, particularly for a less broadly based outcome (e.g., DDAS) compared with the ACR20. The simulation studies demonstrate that data-driven outcome definitions can provide better sensitivity to change than does the ACR20 or DDAS. Using such methods would improve power, but at the expense of trial standardization. The studies also show how patient population and treatment characteristics affect the power of specific outcome measures in RA clinical trials, and provide quantification of those effects.

Assessing the public health impact of cannabis legalization in Canada: core outcome indicators towards an 'index' for monitoring and evaluation.

PubMed

Fischer, Benedikt; Russell, Cayley; Rehm, Jürgen; Leece, Pamela

2018-05-30

The legalization of non-medical cannabis use and supply is impending in Canada. This constitutes a major policy change with the declared objective of improving public health outcomes, which requires rigorous monitoring and evaluation. While numerous different aspects associated with legalization will be examined, a focused perspective is required for effective policy evaluation purposes. To these ends, we have identified a set of 10 core indicators associated with cannabis-related risk/harm outcomes-based on current best evidence-that are expected to measure the primary impacts of legalization on public health outcomes. We briefly review these indicators, and their respective data availability in Canada. As ideally an integrated outcome assessment of cannabis legalization's impact on public health will be available, we further propose options to merge the individual indicators into an integrated, weighted 'index', considering their expected relative impact for public health. One possible approach to undertake this is 'multi-criteria decision analysis' as a method to weight the relative indicator impact on public health; alternative approaches are proposed. The integrated 'public health index' for cannabis legalization will allow for scientifically comprehensive, while focused, monitoring and evaluation of the effects of legalization in Canada for the benefits of science and evidence-based policy alike.

Genetic education and the challenge of genomic medicine: development of core competences to support preparation of health professionals in Europe

PubMed Central

Skirton, Heather; Lewis, Celine; Kent, Alastair; Coviello, Domenico A

2010-01-01

The use of genetics and genomics within a wide range of health-care settings requires health professionals to develop expertise to practise appropriately. There is a need for a common minimum standard of competence in genetics for health professionals in Europe but because of differences in professional education and regulation between European countries, setting curricula may not be practical. Core competences are used as a basis for health professional education in many fields and settings. An Expert Group working under the auspices of the EuroGentest project and European Society of Human Genetics Education Committee agreed that a pragmatic solution to the need to establish common standards for education and practice in genetic health care was to agree to a set of core competences that could apply across Europe. These were agreed through an exhaustive process of consultation with relevant health professionals and patient groups. Sets of competences for practitioners working in primary, secondary and tertiary care have been agreed and were approved by the European Society of Human Genetics. The competences provide an appropriate framework for genetics education of health professionals across national boundaries, and the suggested learning outcomes are available to guide development of curricula that are appropriate to the national context, educational system and health-care setting of the professional involved. Collaboration between individuals from many European countries and professions has resulted in an adaptable framework for both pre-registration and continuing professional education. This competence framework has the potential to improve the quality of genetic health care for patients globally. PMID:20442748

Genetic education and the challenge of genomic medicine: development of core competences to support preparation of health professionals in Europe.

PubMed

Skirton, Heather; Lewis, Celine; Kent, Alastair; Coviello, Domenico A

2010-09-01

The use of genetics and genomics within a wide range of health-care settings requires health professionals to develop expertise to practise appropriately. There is a need for a common minimum standard of competence in genetics for health professionals in Europe but because of differences in professional education and regulation between European countries, setting curricula may not be practical. Core competences are used as a basis for health professional education in many fields and settings. An Expert Group working under the auspices of the EuroGentest project and European Society of Human Genetics Education Committee agreed that a pragmatic solution to the need to establish common standards for education and practice in genetic health care was to agree to a set of core competences that could apply across Europe. These were agreed through an exhaustive process of consultation with relevant health professionals and patient groups. Sets of competences for practitioners working in primary, secondary and tertiary care have been agreed and were approved by the European Society of Human Genetics. The competences provide an appropriate framework for genetics education of health professionals across national boundaries, and the suggested learning outcomes are available to guide development of curricula that are appropriate to the national context, educational system and health-care setting of the professional involved. Collaboration between individuals from many European countries and professions has resulted in an adaptable framework for both pre-registration and continuing professional education. This competence framework has the potential to improve the quality of genetic health care for patients globally.

Systematic Review of Treatment Outcome Measures for Vulvodynia.

PubMed

Sadownik, Leslie A; Yong, Paul J; Smith, Kelly B

2018-07-01

To systematically evaluate the literature regarding vulvodynia treatment outcome measures. A systematic literature search on OVID, PubMed, and PsycINFO databases was conducted from inception until May 2016. Studies were included/excluded based on prespecified criteria. Reported outcome measures were organized into 6 core outcome domains recommended by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT): pain; physical functioning, emotional functioning, participant ratings of global improvement and satisfaction with treatment, symptoms and adverse events, and participant disposition. Of the 206 articles identified for full-text screening, 33 met our criteria. One study adhered to all IMMPACT recommendations. The number of outcomes measured per study ranged from 1 to greater than 20. Patient-reported pain outcomes were found in the majority (27/33; 82%) of studies. Pain severity with intercourse was reported by 24 (73%) of 33 studies-9 different scales were used to measure this outcome. Clinician-reported outcomes were present in 14 (42%) of 33 studies. Methods of measuring vestibular sensitivity by "cotton swab" test were different in 8 of 10 studies. Other domains reported included; physical function (8/33 studies; 24%), sexual function (23/33 studies; 70%), and emotional function (13/33 studies; 39%). Symptoms and adverse events were reported by 15 (45%) of 33 studies. One study formally reported participant disposition using all the information recommended by CONSORT. Comparison of clinical trial results in vulvodynia is not possible because of a lack of standard treatment outcome measures. Vulvodynia researchers should apply the IMMPACT criteria to guide the development of a minimum core set of standard outcome measures that measure holistic health.

Density-based cluster algorithms for the identification of core sets

NASA Astrophysics Data System (ADS)

Lemke, Oliver; Keller, Bettina G.

2016-10-01

The core-set approach is a discretization method for Markov state models of complex molecular dynamics. Core sets are disjoint metastable regions in the conformational space, which need to be known prior to the construction of the core-set model. We propose to use density-based cluster algorithms to identify the cores. We compare three different density-based cluster algorithms: the CNN, the DBSCAN, and the Jarvis-Patrick algorithm. While the core-set models based on the CNN and DBSCAN clustering are well-converged, constructing core-set models based on the Jarvis-Patrick clustering cannot be recommended. In a well-converged core-set model, the number of core sets is up to an order of magnitude smaller than the number of states in a conventional Markov state model with comparable approximation error. Moreover, using the density-based clustering one can extend the core-set method to systems which are not strongly metastable. This is important for the practical application of the core-set method because most biologically interesting systems are only marginally metastable. The key point is to perform a hierarchical density-based clustering while monitoring the structure of the metric matrix which appears in the core-set method. We test this approach on a molecular-dynamics simulation of a highly flexible 14-residue peptide. The resulting core-set models have a high spatial resolution and can distinguish between conformationally similar yet chemically different structures, such as register-shifted hairpin structures.

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.

Exploring methods the for selection and integration of stakeholder views in the development of core outcome sets: a case study in reconstructive breast surgery.

PubMed

Potter, Shelley; Brookes, Sara T; Holcombe, Christopher; Ward, Joseph A; Blazeby, Jane M

2016-09-23

The development and use of core outcome sets (COSs) in trials may improve data synthesis and reduce outcome reporting bias. The selection of outcomes in COSs is informed by views of key stakeholders, yet little is known about the role and influence of different stakeholders' views during COS development. We report an exploratory case study examining how stakeholder selection and incorporation of stakeholders' views may influence the selection of outcomes for a COS in reconstructive breast surgery (RBS). We also make recommendations for future considerations. Key stakeholder groups and subgroups were identified from the literature and expert opinion by the COS management group. They included health care professionals, subdivided by profession (breast and plastic surgeons, specialist nurses and psychologists) and patients, subdivided according to type of surgery received, timing of reconstruction, time since surgery and patient age. All participated in a survey in which they were asked to prioritise outcomes. Outcomes were prioritised using a 9-point scale from 1 (not important) to 9 (extremely important). The proportion of (1) all participants, ignoring stakeholder group (single heterogeneous panel analysis), (2) 'professional' and 'patient' groups separately (two heterogeneous panels), ignoring prespecified subgroups and (3) each participant subgroup separately (multiple homogeneous panel analysis) rating each item 'extremely important' was summarised and compared to explore how selection and integration of stakeholder views may influence outcome prioritisation. There were many overlaps between items rated as most important by all groups. Specific stakeholders, however, prioritised specific concerns and a broader range of outcomes were prioritised when the subgroups were considered separately. For example, two additional outcomes were prioritised when patient and professional groups were considered separately and eight additional outcomes were identified when the views of the individual subgroups were explored. In general, patient subgroups preferentially valued additional clinical outcomes, including unplanned surgery, whereas professional subgroups prioritised additional psychosocial issues including body image. Stakeholder groups value different outcomes. Selection of groups, therefore, is important. Our recommendations for robust and transparent stakeholder selection and integration of stakeholder views may aid future COS developers in the design and conduct of their studies and improve the validity and value of future COS.

Is self disturbance the core of borderline personality disorder? An outcome study of borderline personality factors.

PubMed

Meares, Russell; Gerull, Friederike; Stevenson, Janine; Korner, Anthony

2011-03-01

To determine which constellation of clinical features constitutes the core of borderline personality disorder (BPD). The criterion of endurance was used to identify the constellation of features which are most basic, or core, in borderline personality disorder. Two sets of constellations of DSM-III features were tested, each consisting of three groupings. The first set of constellations was constructed according to Clarkin's factor analysis; the second was theoretically derived. Broadly speaking, the three groupings concerned 'self', 'emotional regulation', and 'impulse'. Changes of these constellations were charted over one year in a comparison of the effect of treatment by the Conversational Model (n = 29) with treatment as usual (n = 31). In addition, measures of typical depression (Zung) were scored before and after the treatment period. The changes in the constellations were considered in relation to authoritative opinion. The changes in the two sets of constellations were similar. In the treatment as usual (TAU) group, 'self' endured unchanged, while 'emotional regulation' and 'impulse' improved. In the Conversational Model cohort, 'self' improved, 'emotional regulation' improved more greatly than the TAU group, while 'impulse' improved but not more than the treatment as usual group. Depression scores were not particularly associated with any grouping. A group of features including self/identity disturbance, emptiness and fear of abandonment may be at the core of BPD. Correlations between the three groupings and Zung scores favoured the view that the core affect is not typical depression. Rather, the central state may be 'painful incoherence'. It is suggested that the findings have implications for the refinement and elaboration of treatment methods in borderline personality disorder.

Performance characteristics of prostate-specific antigen density and biopsy core details to predict oncological outcome in patients with intermediate to high-risk prostate cancer underwent robot-assisted radical prostatectomy.

PubMed

Yashi, Masahiro; Nukui, Akinori; Tokura, Yuumi; Takei, Kohei; Suzuki, Issei; Sakamoto, Kazumasa; Yuki, Hideo; Kambara, Tsunehito; Betsunoh, Hironori; Abe, Hideyuki; Fukabori, Yoshitatsu; Nakazato, Yoshimasa; Kaji, Yasushi; Kamai, Takao

2017-06-23

Many urologic surgeons refer to biopsy core details for decision making in cases of localized prostate cancer (PCa) to determine whether an extended resection and/or lymph node dissection should be performed. Furthermore, recent reports emphasize the predictive value of prostate-specific antigen density (PSAD) for further risk stratification, not only for low-risk PCa, but also for intermediate- and high-risk PCa. This study focused on these parameters and compared respective predictive impact on oncologic outcomes in Japanese PCa patients. Two-hundred and fifty patients with intermediate- and high-risk PCa according to the National Comprehensive Cancer Network (NCCN) classification, that underwent robot-assisted radical prostatectomy at a single institution, and with observation periods of longer than 6 months were enrolled. None of the patients received hormonal treatments including antiandrogens, luteinizing hormone-releasing hormone analogues, or 5-alpha reductase inhibitors preoperatively. PSAD and biopsy core details, including the percentage of positive cores and the maximum percentage of cancer extent in each positive core, were analyzed in association with unfavorable pathologic results of prostatectomy specimens, and further with biochemical recurrence. The cut-off values of potential predictive factors were set through receiver-operating characteristic curve analyses. In the entire cohort, a higher PSAD, the percentage of positive cores, and maximum percentage of cancer extent in each positive core were independently associated with advanced tumor stage ≥ pT3 and an increased index tumor volume > 0.718 ml. NCCN classification showed an association with a tumor stage ≥ pT3 and a Gleason score ≥8, and the attribution of biochemical recurrence was also sustained. In each NCCN risk group, these preoperative factors showed various associations with unfavorable pathological results. In the intermediate-risk group, the percentage of positive cores showed an independent predictive value for biochemical recurrence. In the high-risk group, PSAD showed an independent predictive value. PSAD and biopsy core details have different performance characteristics for the prediction of oncologic outcomes in each NCCN risk group. Despite the need for further confirmation of the results with a larger cohort and longer observation, these factors are important as preoperative predictors in addition to the NCCN classification for a urologic surgeon to choose a surgical strategy.

The selection of core International Classification of Functioning, Disability, and Health (ICF) categories for patient-reported outcome measurement in spine trauma patients-results of an international consensus process.

PubMed

Sadiqi, Said; Lehr, A Mechteld; Post, Marcel W; Jacobs, Wilco C H; Aarabi, Bizhan; Chapman, Jens R; Dunn, Robert N; Dvorak, Marcel F; Fehlings, Michael G; Rajasekaran, S; Vialle, Luiz R; Vaccaro, Alexander R; Oner, F Cumhur

2016-08-01

There is no outcome instrument specifically designed and validated for spine trauma patients without complete paralysis, which makes it difficult to compare outcomes of different treatments of the spinal column injury within and between studies. The paper aimed to report on the evidence-based consensus process that resulted in the selection of core International Classification of Functioning, Disability, and Health (ICF) categories, as well as the response scale for use in a universal patient-reported outcome measure for patients with traumatic spinal column injury. The study used a formal decision-making and consensus process. The sample includes patients with a primary diagnosis of traumatic spinal column injury, excluding completely paralyzed and polytrauma patients. The wide array of function and health status of patients with traumatic spinal column injury was explored through the identification of all potentially meaningful ICF categories. A formal decision-making and consensus process integrated evidence from four preparatory studies. Three studies aimed to identify relevant ICF categories from three different perspectives. The research perspective was covered by a systematic literature review identifying outcome measures focusing on the functioning and health of spine trauma patients. The expert perspective was explored through an international web-based survey among spine surgeons from the five AOSpine International world regions. The patient perspective was investigated in an international empirical study. A fourth study investigated various response scales for their potential use in the future universal outcome instrument. This work was supported by AOSpine. AOSpine is a clinical division of the AO Foundation, an independent medically guided non-profit organization. The AOSpine Knowledge Forums are pathology-focused working groups acting on behalf of AOSpine in their domain of scientific expertise. Combining the results of the preparatory studies, the list of ICF categories presented at the consensus conference included 159 different ICF categories. Based on voting and discussion, 11 experts from 6 countries selected a total of 25 ICF categories as core categories for patient-reported outcome measurement in adult traumatic spinal column injury patients (9 body functions, 14 activities and participation, and 2 environmental factors). The experts also agreed to use the Numeric Rating Scale 0-100 as response scale in the future universal outcome instrument. A formal consensus process integrating evidence and expert opinion led to a set of 25 core ICF categories for patient-reported outcome measurement in adult traumatic spinal column injury patients, as well as the response scale for use in the future universal disease-specific outcome instrument. The adopted core ICF categories could also serve as a benchmark for assessing the content validity of existing and future outcome instruments used in this specific patient population. Copyright © 2016 Elsevier Inc. All rights reserved.

An analysis of the adaptability of a professional development program in public health: results from the ALPS Study.

PubMed

Richard, Lucie; Torres, Sara; Tremblay, Marie-Claude; Chiocchio, François; Litvak, Éric; Fortin-Pellerin, Laurence; Beaudet, Nicole

2015-06-14

Professional development is a key component of effective public health infrastructures. To be successful, professional development programs in public health and health promotion must adapt to practitioners' complex real-world practice settings while preserving the core components of those programs' models and theoretical bases. An appropriate balance must be struck between implementation fidelity, defined as respecting the core nature of the program that underlies its effects, and adaptability to context to maximize benefit in specific situations. This article presents a professional development pilot program, the Health Promotion Laboratory (HPL), and analyzes how it was adapted to three different settings while preserving its core components. An exploratory analysis was also conducted to identify team and contextual factors that might have been at play in the emergence of implementation profiles in each site. This paper describes the program, its core components and adaptive features, along with three implementation experiences in local public health teams in Quebec, Canada. For each setting, documentary sources were analyzed to trace the implementation of activities, including temporal patterns throughout the project for each program component. Information about teams and their contexts/settings was obtained through documentary analysis and semi-structured interviews with HPL participants, colleagues and managers from each organization. While each team developed a unique pattern of implementing the activities, all the program's core components were implemented. Differences of implementation were observed in terms of numbers and percentages of activities related to different components of the program as well as in the patterns of activities across time. It is plausible that organizational characteristics influencing, for example, work schedule flexibility or learning culture might have played a role in the HPL implementation process. This paper shows how a professional development program model can be adapted to different contexts while preserving its core components. Capturing the heterogeneity of the intervention's exposure, as was done here, will make possible in-depth impact analyses involving, for example, the testing of program-context interactions to identify program outcomes predictors. Such work is essential to advance knowledge on the action mechanisms of professional development programs.

Systematic review of the effectiveness of polyurethane-coated compared with textured silicone implants in breast surgery.

PubMed

Duxbury, Paula J; Harvey, James R

2016-04-01

Silicone gel implants are used worldwide for breast augmentation and breast reconstruction. Textured silicone implants are the most commonly placed implant, but polyurethane-coated implants are increasingly being used in an attempt to ameliorate the long-term complications associated with implant insertion. This systematic review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. Electronic searches of MEDLINE, EMBASE, the Cochrane Library and www.ClinicalTrials.gov were undertaken in March 2014 using keywords. Following data extraction, 18 studies were included in the review, including four core studies of textured silicone implants and five studies reporting outcomes for polyurethane-coated silicone implants. There are no clear data reporting revision rates in patients treated with polyurethane implants. In the primary reconstructive setting, capsular contracture rates with silicone implants are 10-15% at 6 years, whilst studies of polyurethane implants report rates of 1.8-3.4%. In the primary augmentation setting, core studies show a capsular contracture rate of 2-15% at 6 years compared with 0.4-1% in polyurethane-coated implants; however, the polyurethane studies are limited by their design and poor follow-up. The use of polyurethane implants should be considered a safe alternative to textured silicone implants. It is likely that an implant surface does influence short- and long-term outcomes; however, the extent of any benefit cannot be determined from the available evidence base. Future implant studies should target the short- and long-term benefits of implant surfacing by procedure with defined outcome measures; a head-to-head comparison would help clarify outcomes. Copyright © 2016 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

Does staff-patient agreement on needs for care predict a better mental health outcome? A 4-year follow-up in a community service.

PubMed

Lasalvia, A; Bonetto, C; Tansella, M; Stefani, B; Ruggeri, M

2008-01-01

Patients treated in primary care settings report better mental outcomes when they agree with practitioners about the nature of their core presenting problems. However, no study has examined the impact of staff-patient agreement on treatment outcomes in specialist mental health services. We investigated whether a better staff-patient agreement on needs for care predicts more favourable outcome in patients receiving community-based psychiatric care. A 3-month prevalence cohort of 188 patients with the full spectrum of psychiatric conditions was assessed at baseline and at 4 years using the Camberwell Assessment of Need (CAN), both staff (CAN-S) and patient versions (CAN-P), and a set of standardized outcome measures. Baseline staff-patient agreement on needs was included among predictors of outcome. Both clinician-rated (psychopathology, social disability, global functioning) and patient-rated (subjective quality of life and satisfaction with services) outcomes were considered. Controlling for the effect of sociodemographics, service utilization and changes in clinical status, better staff-patient agreement makes a significant additional contribution in predicting treatment outcomes not only on patient-rated but also on clinician-rated measures. Mental health care should be provided on the basis of a negotiation process involving both professionals and service users to ensure effective interventions; every effort should be made by services to implement strategies aiming to increase consensus between staff and patients.

Newberry Volcano EGS Demonstration Stimulation Modeling

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

Trenton T. Cladouhos, Matthew Clyne, Maisie Nichols,; Susan Petty, William L. Osborn, Laura Nofziger

2011-10-23

As a part of Phase I of the Newberry Volcano EGS Demonstration project, several data sets were collected to characterize the rock volume around the well. Fracture, fault, stress, and seismicity data has been collected by borehole televiewer, LiDAR elevation maps, and microseismic monitoring. Well logs and cuttings from the target well (NWG 55-29) and core from a nearby core hole (USGS N-2) have been analyzed to develop geothermal, geochemical, mineralogical and strength models of the rock matrix, altered zones, and fracture fillings (see Osborn et al., this volume). These characterization data sets provide inputs to models used to planmore » and predict EGS reservoir creation and productivity. One model used is AltaStim, a stochastic fracture and flow software model developed by AltaRock. The software's purpose is to model and visualize EGS stimulation scenarios and provide guidance for final planning. The process of creating an AltaStim model requires synthesis of geologic observations at the well, the modeled stress conditions, and the stimulation plan. Any geomechanical model of an EGS stimulation will require many assumptions and unknowns; thus, the model developed here should not be considered a definitive prediction, but a plausible outcome given reasonable assumptions. AltaStim is a tool for understanding the effect of known constraints, assumptions, and conceptual models on plausible outcomes.« less

Improving core outcome set development: qualitative interviews with developers provided pointers to inform guidance.

PubMed

Gargon, Elizabeth; Williamson, Paula R; Young, Bridget

2017-06-01

The objective of the study was to explore core outcome set (COS) developers' experiences of their work to inform methodological guidance on COS development and identify areas for future methodological research. Semistructured, audio-recorded interviews with a purposive sample of 32 COS developers. Analysis of transcribed interviews was informed by the constant comparative method and framework analysis. Developers found COS development to be challenging, particularly in relation to patient participation and accessing funding. Their accounts raised fundamental questions about the status of COS development and whether it is consultation or research. Developers emphasized how the absence of guidance had affected their work and identified areas where guidance or evidence about COS development would be useful including, patient participation, ethics, international development, and implementation. They particularly wanted guidance on systematic reviews, Delphi, and consensus meetings. The findings raise important questions about the funding, status, and process of COS development and indicate ways that it could be strengthened. Guidance could help developers to strengthen their work, but over specification could threaten quality in COS development. Guidance should therefore highlight common issues to consider and encourage tailoring of COS development to the context and circumstances of particular COS. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

The Gene Therapy Resource Program: A Decade of Dedication to Translational Research by the National Heart, Lung, and Blood Institute.

PubMed

Flotte, Terence R; Daniels, Eric; Benson, Janet; Bevett-Rose, Jeneé M; Cornetta, Kenneth; Diggins, Margaret; Johnston, Julie; Sepelak, Susan; van der Loo, Johannes C M; Wilson, James M; McDonald, Cheryl L

2017-12-01

Over a 10-year period, the Gene Therapy Resource Program (GTRP) of the National Heart Lung and Blood Institute has provided a set of core services to investigators to facilitate the clinical translation of gene therapy. These services have included a preclinical (research-grade) vector production core; current Good Manufacturing Practice clinical-grade vector cores for recombinant adeno-associated virus and lentivirus vectors; a pharmacology and toxicology core; and a coordinating center to manage program logistics and to provide regulatory and financial support to early-phase clinical trials. In addition, the GTRP has utilized a Steering Committee and a Scientific Review Board to guide overall progress and effectiveness and to evaluate individual proposals. These resources have been deployed to assist 82 investigators with 172 approved service proposals. These efforts have assisted in clinical trial implementation across a wide range of genetic, cardiac, pulmonary, and blood diseases. Program outcomes and potential future directions of the program are discussed.

Physical outcome measures for conductive and mixed hearing loss treatment: A systematic review.

PubMed

Johansson, M L; Tysome, J R; Hill-Feltham, P; Hodgetts, W E; Ostevik, A; McKinnon, B J; Monksfield, P; Sockalingam, R; Wright, T

2018-05-07

The number of potential options for rehabilitation of patients with conductive or mixed hearing loss is continually expanding. To be able to inform patients and other stakeholders there is a need to identify and develop patient-centred outcomes for treatment of hearing loss. To identify outcome measures in the physical core area used when reporting the outcome after treatment of conductive and mixed hearing loss in adult patients. Systematic review. Systematic review of literature related to reported physical outcome measures after treatment of mixed or conductive hearing loss without restrictions regarding type of intervention, treatment or device. Any measure reporting the physical outcome after treatment or intervention of mixed or conductive hearing loss was sought and categorised. The physical outcomes measures that had been extracted were then grouped into domains. The literature search resulted in the identification of 1,434 studies, of which 153 were selected for inclusion in the review. The majority (57%) of papers reported results from middle ear surgery, with the remainder reporting results from either bone conduction hearing devices or middle ear implants. Outcomes related to complications were categorised into 17 domains, whereas outcomes related to treatment success was categorised in 22 domains. The importance of these domains to patients and other stakeholders needs to be further explored in order to establish which of these domains are most relevant to interventions for conductive or mixed hearing loss. This will allow us to then assess which outcomes measures are most suitable for inclusion in the core set This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Incorporating the International Polar Year Into Introductory Geology Laboratories at Ohio State University

NASA Astrophysics Data System (ADS)

Judge, S. A.; Wilson, T. J.

2005-12-01

The International Polar Year (IPY) provides an excellent opportunity for highlighting polar research in education. The ultimate goal of our outreach and education program is to develop a series of modules that are focused on societally-relevant topics being investigated in Antarctic earth science, while teaching basic geologic concepts that are standard elements of school curricula. For example, we envision a university-level, undergraduate, introductory earth science class with the entire semester/quarter laboratory program focused on polar earth science research during the period of the International Polar Year. To attain this goal, a series of modules will be developed, including inquiry-based exercises founded on imagery (video, digital photos, digital core scans), GIS data layers, maps, and data sets available from OSU research groups. Modules that highlight polar research are also suitable for the K-12 audience. Scaleable/grade appropriate modules that use some of the same data sets as the undergraduate modules can be outlined for elementary through high school earth science classes. An initial module is being developed that focuses on paleoclimate data. The module provides a hands-on investigation of the climate history archived in both ice cores and sedimentary rock cores in order to understand time scales, drivers, and processes of global climate change. The paleoclimate module also demonstrates the types of polar research that are ongoing at OSU, allowing students to observe what research the faculty are undertaking in their respective fields. This will link faculty research with student education in the classroom, enhancing learning outcomes. Finally, this module will provide a direct link to U.S. Antarctic Program research related to the International Polar Year, when new ice and sedimentary rock cores will be obtained and analyzed. As a result of this laboratory exercise, the students will be able to: (1) Define an ice core and a sedimentary rock core. (Knowledge) (2) Identify climate indicators in each type of core by using digital core images. These include layers of particulate material (such as volcanic tephra) in ice cores and layers of larger grains (such as ice-rafted debris) in sedimentary rock cores. (Knowledge) (3) Describe how cores are taken in extreme environments, such as Antarctica. (Comprehension) (4) Use actual data from proxies in the ice and sedimentary records to graph changes through time in the cores. (Application) (5) Recognize variances in data sets that might illustrate periods of climate change. (Analysis) (6) Integrate data results from several proxies in order to construct a climate record for both ice cores and sedimentary rock cores. (Synthesis) (7) Interpret both the ice core and sedimentary rock core records to ascertain the effectiveness of both of these tools in archiving climate records. (Evaluation)

International Classification of Functioning, Disability and Health Core Sets for cerebral palsy, autism spectrum disorder, and attention-deficit-hyperactivity disorder.

PubMed

Schiariti, Verónica; Mahdi, Soheil; Bölte, Sven

2018-05-30

Capturing functional information is crucial in childhood disability. The International Classification of Functioning, Disability and Health (ICF) Core Sets promote assessments of functional abilities and disabilities in clinical practice regarding circumscribed diagnoses. However, the specificity of ICF Core Sets for childhood-onset disabilities has been doubted. This study aimed to identify content commonalities and differences among the ICF Core Sets for cerebral palsy (CP), and the newly developed Core Sets for autism spectrum disorder (ASD) and attention-deficit-hyperactivity disorder (ADHD). The categories within each Core Set were aggregated at the ICF component and chapter levels. Content comparison was conducted using descriptive analyses. The activities and participation component of the ICF was the most covered across all Core Sets. Main differences included representation of ICF components and coverage of ICF chapters within each component. CP included all ICF components, while ADHD and ASD predominantly focused on activities and participation. Environmental factors were highly represented in the ADHD Core Sets (40.5%) compared to the ASD (28%) and CP (27%) Core Sets. International Classification of Functioning, Disability and Health Core Sets for CP, ASD, and ADHD capture both common but also unique functional information, showing the importance of creating condition-specific, ICF-based tools to build functional profiles of individuals with childhood-onset disabilities. The International Classification of Functioning, Disability and Health (ICF) Core Sets for cerebral palsy (CP), autism spectrum disorder (ASD), and attention-deficit-hyperactivity disorder (ADHD) include unique functional information. The ICF-based tools for CP, ASD, and ADHD differ in terms of representation and coverage of ICF components and ICF chapters. Representation of environmental factors uniquely influences functioning and disability across ICF Core Sets for CP, ASD and ADHD. © 2018 Mac Keith Press.

Behavioral Health and Performance Laboratory Standard Measures (BHP-SM)

NASA Technical Reports Server (NTRS)

Williams, Thomas J.; Cromwell, Ronita

2017-01-01

The Spaceflight Standard Measures is a NASA Johnson Space Center Human Research Project (HRP) project that proposes to collect a set of core measurements, representative of many of the human spaceflight risks, from astronauts before, during and after long-duration International Space Station (ISS) missions. The term "standard measures" is defined as a set of core measurements, including physiological, biochemical, psychosocial, cognitive, and functional, that are reliable, valid, and accepted in terrestrial science, are associated with a specific and measurable outcome known to occur as a consequence of spaceflight, that will be collected in a standardized fashion from all (or most) crewmembers. While such measures might be used to define standards of health and performance or readiness for flight, the prime intent in their collection is to allow longitudinal analysis of multiple parameters in order to answer a variety of operational, occupational, and research-based questions. These questions are generally at a high level, and the approach for this project is to populate the standard measures database with the smallest set of data necessary to indicate further detailed research is required. Also included as standard measures are parameters that are not outcome-based in and of-themselves, but provide ancillary information that supports interpretation of the outcome measures, e.g., nutritional assessment, vehicle environmental parameters, crew debriefs, etc. The project's main aim is to ensure that an optimized minimal set of measures is consistently captured from all ISS crewmembers until the end of Station in order to characterize the human in space. -This allows the HRP to identify, establish, and evaluate a common set of measures for use in spaceflight and analog research to: develop baselines, systematically characterize risk likelihood and consequences, and assess effectiveness of countermeasures that work for behavioral health and performance risk factors. -By standardizing the battery of measures on all crewmembers, it will allow the HRP to evaluate countermeasures that work for one physiological system and ensure another system is not negatively affected. -These measures, named "Standard Measures," will serve as a data repository and be available to other studies under data sharing agreements.

Defining and evaluating novel procedures for involving patients in Core Outcome Set research: creating a meaningful long list of candidate outcome domains.

PubMed

Smith, Harriet; Horobin, Adele; Fackrell, Kathryn; Colley, Veronica; Thacker, Brian; Hall, Deborah A

2018-01-01

Outcome domains are aspects of a condition that matter to patients and clinicians and can be measured to assess treatment effects. For tinnitus, examples include 'tinnitus loudness' and 'ability to concentrate'. This study focuses on the first stage of agreeing which outcome domains should be measured in all clinical trials of tinnitus. Crucially, it involves identifying outcome domains, prior to a voting process. This article describes how we effectively involved patients in that study design process, and reflects on the impact of their input.The study first compiled a long list of all possible outcome domains before asking interested parties, including patients, to vote which ones to include. Ensuring patients fully participate in this process holds unique challenges as it can be long, repetitive and its purpose far removed from their needs. These challenges may be addressed by involving patients in designing the research. There is evidence that other research teams are doing this, but its reporting is not detailed enough to guide others. Our paper seeks to address this.We describe how we involved patients (people living with tinnitus) in creating a long list of outcome domains that we included in our study. We also reflect on the benefits this brought. Two patients partnered with us in designing the survey. We also consulted an independent patient review panel. Involving patients reduced the list of domains included in the survey and made domain names and associated descriptions clearer. Our resulting survey performed well in recruiting and retaining patients as participants. Background Tinnitus is a complex audiological condition affecting many different domains of everyday life. Clinical trials of tinnitus interventions measure and report those outcome domains inconsistently and this hinders direct comparison between study findings. To address this problem, an ongoing project is developing a Core Outcome Set; an agreed list of outcome domains to be measured and reported in all future trials. Part of this project uses a consensus methodology ('Delphi' survey), whereby all relevant stakeholders identify important and critical outcome domains from a long list of candidates. This article addresses a gap in the patient involvement literature by describing and reflecting on our involvement of patients to create a meaningful long list of candidate outcome domains. Methods Two Public Research Partners with lived experience of tinnitus reviewed an initial list of 124 outcome domains over two face-to-face workshops. With the Study Management Team, they interpreted each candidate outcome domain and generated a plain language description. Following this, the domain names and descriptions underwent an additional lay review by 14 patients and 5 clinical experts, via an online survey platform. Results Insights gained from the workshops and survey feedback prompted substantial, unforeseen modifications to the long list. These included the reduction of the number of outcome domains (from 124 to 66) via the exclusion of broad concepts and consolidation of equivalent domains or domains outside the scope of the study. Reviewers also applied their lived experience of tinnitus to bring clarity and relevance to domain names and plain language descriptions. Four impacts on the Delphi survey were observed: recruitment exceeded the target by 171%, there were equivalent numbers of patient and professional participants ( n  = 358 and n  = 312, respectively), feedback was mostly positive, and retention was high (87%). Conclusions Patient involvement was an integral and transformative step of the study design process. Patient involvement was impactful because the online Delphi survey was successful in recruiting and retaining participants, and there were many comments about a positive participatory experience. Seven general methodological features are highlighted which fit with general principles of good patient involvement. These can benefit other Core Outcome Set developers.

The Importance of Social Cognition in Improving Functional Outcomes in Schizophrenia

PubMed Central

Javed, Afzal; Charles, Asha

2018-01-01

Social cognition has become recognized as an important driver of functional outcomes and overall recovery in patients with schizophrenia, mediating the relationship between neurocognition and social functioning. Since antipsychotic therapy targeting remission of clinical symptoms has been shown to have a limited impact on social cognition, there has been an increasing drive to develop therapeutic strategies to specifically improve social cognition in schizophrenia. We sought to review current evidence relating to social cognition in schizophrenia and its clinical implications, including interventions designed to target the core domains of social cognition (emotion processing, theory of mind, attributional bias, and social perception) as a means of improving functional outcomes and thereby increasing the likelihood of recovery. Relevant articles were identified by conducting a literature search in PubMed using the search terms “schizophrenia” AND “cognition” AND “social functioning,” limited to Title/Abstract, over a time period of the past 10 years. Current evidence demonstrates that schizophrenia is associated with impairments in all four core domains of social cognition, during the pre-first-episode, first-episode, early, and chronic phases of the disease, and that such impairments are important determinants of functional outcome. Interventions targeting the four core domains of social cognition comprise psychosocial approaches (social cognition training programs) and pharmacological therapies. Social cognition training programs targeting multiple and specific core domains of social cognition have shown promise in improving social cognition skills, which, in some cases, has translated into improvements in functional outcomes. Use of some psychosocial interventions has additionally resulted in improvements in clinical symptoms and/or quality of life. Pharmacological therapies, including oxytocin and certain antipsychotics, have yielded more mixed results, due in part to the confounding impact of factors including variation in receptor genetics, bioavailability, pharmacokinetics, and drug–drug interactions, and inconsistencies between study designs and medication dosages. Additional research is required to advance our understanding of the role of social cognition in schizophrenia, and to further establish the utility of targeted interventions in this setting. PMID:29740360

The association between waiting for psychological therapy and therapy outcomes as measured by the CORE-OM.

PubMed

Beck, Alison; Burdett, Mark; Lewis, Helen

2015-06-01

To investigate the impact of waiting for psychological therapy on client well-being as measured by the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) global distress (GD) score. Global distress scores were retrieved for all clients referred for psychological therapy in a secondary care mental health service between November 2006 and May 2013 and who had completed a CORE-OM at assessment and first session. GD scores for a subgroup of 103 clients who had completed a CORE-OM during the last therapy session were also reviewed. The study sample experienced a median wait of 41.14 weeks between assessment and first session. The relationship between wait time from referral acceptance to assessment, and assessment GD score was not significant. During the period between assessment and first session no significant difference in GD score was observed. Nevertheless 29.1% of the sample experienced reliable change; 16.0% of clients reliably improved and 13.1% reliably deteriorated whilst waiting for therapy. Demographic factors were not found to have a significant effect on the change in GD score between assessment and first session. Waiting time was associated with post-therapy outcomes but not to a degree which was meaningful. The majority of individuals (54.4%), regardless of whether they improved or deteriorated whilst waiting for therapy, showed reliable improvement at end of therapy as measured by the CORE-OM. The majority of GD scores remained stable while waiting for therapy; however, 29.1% of secondary care clients experienced either reliable improvement or deterioration. Irrespective of whether they improved, deteriorated or remained unchanged whilst waiting for therapy, most individuals who had a complete end of therapy assessment showed reliable improvements following therapy. There was no significant difference in GD score between assessment and first session recordings. A proportion of clients (29.1%) showed reliable change, either improvement or deterioration, as measured by the GD score while waiting for therapy. Of the individuals with last session CORE-OMs (54.4%) showed significant improvement following therapy regardless of whether or not they experienced change while waiting for therapy. Limitations include: Problems of data quality, the data were from a routine data set and data were lost at each stage of the analysis. A focus on the CORE-OM limits exploration of the subjective experience of waiting for psychotherapy and the impact this has on psychological well-being. © 2014 The British Psychological Society.

The use of qualitative methods to inform Delphi surveys in core outcome set development.

PubMed

Keeley, T; Williamson, P; Callery, P; Jones, L L; Mathers, J; Jones, J; Young, B; Calvert, M

2016-05-04

Core outcome sets (COS) help to minimise bias in trials and facilitate evidence synthesis. Delphi surveys are increasingly being used as part of a wider process to reach consensus about what outcomes should be included in a COS. Qualitative research can be used to inform the development of Delphi surveys. This is an advance in the field of COS development and one which is potentially valuable; however, little guidance exists for COS developers on how best to use qualitative methods and what the challenges are. This paper aims to provide early guidance on the potential role and contribution of qualitative research in this area. We hope the ideas we present will be challenged, critiqued and built upon by others exploring the role of qualitative research in COS development. This paper draws upon the experiences of using qualitative methods in the pre-Delphi stage of the development of three different COS. Using these studies as examples, we identify some of the ways that qualitative research might contribute to COS development, the challenges in using such methods and areas where future research is required. Qualitative research can help to identify what outcomes are important to stakeholders; facilitate understanding of why some outcomes may be more important than others, determine the scope of outcomes; identify appropriate language for use in the Delphi survey and inform comparisons between stakeholder data and other sources, such as systematic reviews. Developers need to consider a number of methodological points when using qualitative research: specifically, which stakeholders to involve, how to sample participants, which data collection methods are most appropriate, how to consider outcomes with stakeholders and how to analyse these data. A number of areas for future research are identified. Qualitative research has the potential to increase the research community's confidence in COS, although this will be dependent upon using rigorous and appropriate methodology. We have begun to identify some issues for COS developers to consider in using qualitative methods to inform the development of Delphi surveys in this article.

A practical guide to self-sustaining point-of-care ultrasound education programs in resource-limited settings.

PubMed

Henwood, Patricia C; Mackenzie, David C; Rempell, Joshua S; Murray, Alice F; Leo, Megan M; Dean, Anthony J; Liteplo, Andrew S; Noble, Vicki E

2014-09-01

The value of point-of-care ultrasound education in resource-limited settings is increasingly recognized, though little guidance exists on how to best construct a sustainable training program. Herein we offer a practical overview of core factors to consider when developing and implementing a point-of-care ultrasound education program in a resource-limited setting. Considerations include analysis of needs assessment findings, development of locally relevant curriculum, access to ultrasound machines and related technological and financial resources, quality assurance and follow-up plans, strategic partnerships, and outcomes measures. Well-planned education programs in these settings increase the potential for long-term influence on clinician skills and patient care. Copyright © 2014 American College of Emergency Physicians. Published by Mosby, Inc. All rights reserved.

The Quality of Reporting of Abstracts in Physical Therapy Literature is Suboptimal: Cross-Sectional, Bibliographic Analysis.

PubMed

Richter, Randy R; Sebelski, Chris A; Austin, Tricia M

2016-09-01

The quality of abstract reporting in physical therapy literature is unknown. The purpose of this study was to provide baseline data for judging the future impact of the 2010 Consolidated Standards of Reporting Trials statement specifically referencing the 2008 Consolidated Standards of Reporting Trials statement for reporting of abstracts of randomized controlled trials across and between a broad sample and a core sample of physical therapy literature. A cross-sectional, bibliographic analysis was conducted. Abstracts of randomized controlled trials from 2009 were retrieved from PubMed, PEDro, and CENTRAL. Eligibility was determined using PEDro criteria. For outcomes measures, items from the Consolidated Standards of Reporting Trials statement for abstract reporting were used for assessment. Raters were not blinded to citation details. Using a computer-generated set of random numbers, 150 abstracts from 112 journals comprised the broad sample. A total of 53 abstracts comprised the core sample. Fourteen of 20 Consolidated Standards of Reporting Trials items for both samples were reported in less than 50% of the abstracts. Significantly more abstracts in the core sample reported (% difference core - broad; 95% confidence interval) title (28.4%; 12.9%-41.2%), blinding (15.2%; 1.6%-29.8%), setting (47.6%; 32.4%-59.4%), and confidence intervals (13.1%; 5.0%-25.1%). These findings provide baseline data for determining if continuing efforts to improve abstract reporting are heeded.

Development of a Core Clinical Dataset to Characterize Serious Illness, Injuries, and Resource Requirements for Acute Medical Responses to Public Health Emergencies.

PubMed

Murphy, David J; Rubinson, Lewis; Blum, James; Isakov, Alexander; Bhagwanjee, Statish; Cairns, Charles B; Cobb, J Perren; Sevransky, Jonathan E

2015-11-01

In developed countries, public health systems have become adept at rapidly identifying the etiology and impact of public health emergencies. However, within the time course of clinical responses, shortfalls in readily analyzable patient-level data limit capabilities to understand clinical course, predict outcomes, ensure resource availability, and evaluate the effectiveness of diagnostic and therapeutic strategies for seriously ill and injured patients. To be useful in the timeline of a public health emergency, multi-institutional clinical investigation systems must be in place to rapidly collect, analyze, and disseminate detailed clinical information regarding patients across prehospital, emergency department, and acute care hospital settings, including ICUs. As an initial step to near real-time clinical learning during public health emergencies, we sought to develop an "all-hazards" core dataset to characterize serious illness and injuries and the resource requirements for acute medical response across the care continuum. A multidisciplinary panel of clinicians, public health professionals, and researchers with expertise in public health emergencies. Group consensus process. The consensus process included regularly scheduled conference calls, electronic communications, and an in-person meeting to generate candidate variables. Candidate variables were then reviewed by the group to meet the competing criteria of utility and feasibility resulting in the core dataset. The 40-member panel generated 215 candidate variables for potential dataset inclusion. The final dataset includes 140 patient-level variables in the domains of demographics and anthropometrics (7), prehospital (11), emergency department (13), diagnosis (8), severity of illness (54), medications and interventions (38), and outcomes (9). The resulting all-hazard core dataset for seriously ill and injured persons provides a foundation to facilitate rapid collection, analyses, and dissemination of information necessary for clinicians, public health officials, and policymakers to optimize public health emergency response. Further work is needed to validate the effectiveness of the dataset in a variety of emergency settings.

Temperature variability during targeted temperature management is not associated with neurological outcomes following cardiac arrest.

PubMed

Nayeri, Arash; Bhatia, Nirmanmoh; Holmes, Benjamin; Borges, Nyal; Armstrong, William; Xu, Meng; Farber-Eger, Eric; Wells, Quinn S; McPherson, John A

2017-06-01

Recent studies on comatose survivors of cardiac arrest undergoing targeted temperature management (TTM) have shown similar outcomes at multiple target temperatures. However, details regarding core temperature variability during TTM and its prognostic implications remain largely unknown. We sought to assess the association between core temperature variability and neurological outcomes in patients undergoing TTM following cardiac arrest. We analyzed a prospectively collected cohort of 242 patients treated with TTM following cardiac arrest at a tertiary care hospital between 2007 and 2014. Core temperature variability was defined as the statistical variance (i.e. standard deviation squared) amongst all core temperature recordings during the maintenance phase of TTM. Poor neurological outcome at hospital discharge, defined as a Cerebral Performance Category (CPC) score>2, was the primary outcome. Death prior to hospital discharge was assessed as the secondary outcome. Multivariable logistic regression was used to examine the association between temperature variability and neurological outcome or death at hospital discharge. A poor neurological outcome was observed in 147 (61%) patients and 136 (56%) patients died prior to hospital discharge. In multivariable logistic regression, increased core temperature variability was not associated with increased odds of poor neurological outcomes (OR 0.38, 95% CI 0.11-1.38, p=0.142) or death (OR 0.43, 95% CI 0.12-1.53, p=0.193) at hospital discharge. In this study, individual core temperature variability during TTM was not associated with poor neurological outcomes or death at hospital discharge. Copyright © 2017 Elsevier Inc. All rights reserved.

American Society for Enhanced Recovery (ASER) and Perioperative Quality Initiative (POQI) joint consensus statement on measurement to maintain and improve quality of enhanced recovery pathways for elective colorectal surgery.

PubMed

Moonesinghe, S Ramani; Grocott, Michael P W; Bennett-Guerrero, Elliott; Bergamaschi, Roberto; Gottumukkala, Vijaya; Hopkins, Thomas J; McCluskey, Stuart; Gan, Tong J; Mythen, Michael Monty G; Shaw, Andrew D; Miller, Timothy E

2017-01-01

This article sets out a framework for measurement of quality of care relevant to enhanced recovery pathways (ERPs) in elective colorectal surgery. The proposed framework is based on established measurement systems and/or theories, and provides an overview of the different approaches for improving clinical monitoring, and enhancing quality improvement or research in varied settings with different levels of available resources. Using a structure-process-outcome framework, we make recommendations for three hierarchical tiers of data collection. Core, Quality Improvement, and Best Practice datasets are proposed. The suggested datasets incorporate patient data to describe case-mix, process measures to describe delivery of enhanced recovery and clinical outcomes. The fundamental importance of routine collection of data for the initiation, maintenance, and enhancement of enhanced recovery pathways is emphasized.

Core Outcome Set–STAndards for Reporting: The COS-STAR Statement

PubMed Central

Kirkham, Jamie J.; Gorst, Sarah; Altman, Douglas G.; Blazeby, Jane M.; Clarke, Mike; Devane, Declan; Moher, David; Schmitt, Jochen; Tugwell, Peter; Tunis, Sean; Williamson, Paula R.

2016-01-01

Background Core outcome sets (COS) can enhance the relevance of research by ensuring that outcomes of importance to health service users and other people making choices about health care in a particular topic area are measured routinely. Over 200 COS to date have been developed, but the clarity of these reports is suboptimal. COS studies will not achieve their goal if reports of COS are not complete and transparent. Methods and Findings In recognition of these issues, an international group that included experienced COS developers, methodologists, journal editors, potential users of COS (clinical trialists, systematic reviewers, and clinical guideline developers), and patient representatives developed the Core Outcome Set–STAndards for Reporting (COS-STAR) Statement as a reporting guideline for COS studies. The developmental process consisted of an initial reporting item generation stage and a two-round Delphi survey involving nearly 200 participants representing key stakeholder groups, followed by a consensus meeting. The COS-STAR Statement consists of a checklist of 18 items considered essential for transparent and complete reporting in all COS studies. The checklist items focus on the introduction, methods, results, and discussion section of a manuscript describing the development of a particular COS. A limitation of the COS-STAR Statement is that it was developed without representative views of low- and middle-income countries. COS have equal relevance to studies conducted in these areas, and, subsequently, this guideline may need to evolve over time to encompass any additional challenges from developing COS in these areas. Conclusions With many ongoing COS studies underway, the COS-STAR Statement should be a helpful resource to improve the reporting of COS studies for the benefit of all COS users. PMID:27755541

24/7 Presence of Medical Staff in the Labor Ward; No Day-Night Differences in Perinatal and Maternal Outcomes.

PubMed

Tavares, Sara; Cavaco-Gomes, João; Moucho, Marina; Severo, Milton; Mateus, Mário; Ramalho, Carla; Visser, Gerard H A; Montenegro, Nuno

2017-05-01

Objective  The objective of this study was to assess possible day-night differences in perinatal and maternal labor outcomes in a hospital setting with no day-night differences in the presence of experienced medical staff. Design  This was a retrospective study conducted over 5 years between 2008 and 2012. Setting  This study was set at the obstetric delivery unit in a tertiary hospital. Population  A total of 9,143 singleton deliveries were assessed after 34 weeks of gestation and after exclusion of major congenital malformations, inductions of labor, and elective cesarean sections. Materials and Methods  Data were collected using the hospital electronic medical records. Time periods of 8 hours were defined (daytime between 8 am and 4 pm, evening time between 4 pm and 12 pm, and nighttime between 12 pm and 8 am). Differences between the three time periods were assessed using software R Core Team (2013). Main outcome measures were neonatal birth asphyxia, neonatal intensive care unit admission, and neonatal death. Results  There were no differences in perinatal and maternal outcomes in the course of the day, apart from a higher incidence of third- and fourth-degree tears during the evening. Neonatal outcome after obstetric emergencies (uterine rupture, partial placental abruption, and cord prolapse) also showed no day-night differences. Conclusion  Adverse nighttime-related outcomes may be avoided by the 24/7 presence of experienced medical staff. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

A current review of core decompression in the treatment of osteonecrosis of the femoral head.

PubMed

Pierce, Todd P; Jauregui, Julio J; Elmallah, Randa K; Lavernia, Carlos J; Mont, Michael A; Nace, James

2015-09-01

The review describes the following: (1) how traditional core decompression is performed, (2) adjunctive treatments, (3) multiple percutaneous drilling technique, and (4) the overall outcomes of these procedures. Core decompression has optimal outcomes when used in the earliest, precollapse disease stages. More recent studies have reported excellent outcomes with percutaneous drilling. Furthermore, adjunct treatment methods combining core decompression with growth factors, bone morphogenic proteins, stem cells, and bone grafting have demonstrated positive results; however, larger randomized trial is needed to evaluate their overall efficacy.

Globalization, migration health, and educational preparation for transnational medical encounters

PubMed Central

Koehn, Peter H

2006-01-01

Unprecedented migration, a core dimension of contemporary globalization, challenges population health. In a world of increasing human mobility, many health outcomes are shaped by transnational interactions among care providers and care recipients who meet in settings where nationality/ethnic match is not an option. This review article explores the value of transnational competence (TC) education as preparation for ethnically and socially discordant clinical encounters. The relevance of TC's five core skill domains (analytic, emotional, creative, communicative, and functional) for migration health and the medical-school curriculum is elaborated. A pedagogical approach that prepares for the transnational health-care consultation is presented, with a focus on clinical-clerkship learning experiences. Educational preparation for contemporary medical encounters needs to include a comprehensive set of patient-focused interpersonal skills, be adaptable to a wide variety of service users and global practice sites, and possess utility in addressing both the quality of patient care and socio-political constraints on migration health. PMID:16441899

Recommended patient-reported core set of symptoms to measure in prostate cancer treatment trials.

PubMed

Chen, Ronald C; Chang, Peter; Vetter, Richard J; Lukka, Himansu; Stokes, William A; Sanda, Martin G; Watkins-Bruner, Deborah; Reeve, Bryce B; Sandler, Howard M

2014-07-01

The National Cancer Institute (NCI) Symptom Management and Health-Related Quality of Life Steering Committee convened four working groups to recommend core sets of patient-reported outcomes to be routinely incorporated in clinical trials. The Prostate Cancer Working Group included physicians, researchers, and a patient advocate. The group's process included 1) a systematic literature review to determine the prevalence and severity of symptoms, 2) a multistakeholder meeting sponsored by the NCI to review the evidence and build consensus, and 3) a postmeeting expert panel synthesis of findings to finalize recommendations. Five domains were recommended for localized prostate cancer: urinary incontinence, urinary obstruction and irritation, bowel-related symptoms, sexual dysfunction, and hormonal symptoms. Four domains were recommended for advanced prostate cancer: pain, fatigue, mental well-being, and physical well-being. Additional domains for consideration include decisional regret, satisfaction with care, and anxiety related to prostate cancer. These recommendations have been endorsed by the NCI for implementation. © The Author 2014. Published by Oxford University Press. All rights reserved.

The impact of teachers’ modifications of an evidenced-based HIV prevention intervention on program outcomes

PubMed Central

Wang, Bo; Stanton, Bonita; Lunn, Sonja; Rolle, Glenda; Poitier, Maxwell; Adderley, Richard; Li, Xiaoming; Koci, Veronica; Deveaux, Lynette

2015-01-01

The degree to which evidence-based program outcomes are affected by modifications is a significant concern in the implementation of interventions. The ongoing national implementation of an evidence-based HIV prevention program targeting grade six students in The Bahamas [Focus on Youth in The Caribbean (FOYC)] offers an opportunity to explore factors associated with teachers’ modification of FOYC lessons and to examine the impact of types and degrees of modifications on student outcomes. Data were collected in 2012 from 155 teachers and 3646 students in 77 government elementary schools. Results indicate that teachers taught 16 of 30 core activities, 24.5 of 46 total activities and 4.7 of 8 sessions. Over one-half of the teachers made modifications to FOYC core activities; one-fourth of the teachers modified 25% or more core activities that they taught (heavily modified FOYC). Omitting core activities was the most common content modification, followed by lengthening FOYC lessons with reading, writing assignments or role-play games, shortening core activities or adding educational videos. Mixed-effects modeling revealed that omitting core activities had negative impacts on all four student outcomes. Shortening core activities and adding videos into lessons had negative impacts on HIV/AIDS knowledge and/or intention to use condom protection. Heavy modifications (>1/4 core activities) were associated with diminished program effectiveness. Heavy modifications and omitting or shortening core activities were negatively related to teachers’ level of implementation. We conclude that poorer student outcomes were associated with heavy modifications. PMID:26297497

The Impact of Teachers' Modifications of an Evidenced-Based HIV Prevention Intervention on Program Outcomes.

PubMed

Wang, Bo; Stanton, Bonita; Lunn, Sonja; Rolle, Glenda; Poitier, Maxwell; Adderley, Richard; Li, Xiaoming; Koci, Veronica; Deveaux, Lynette

2016-01-01

The degree to which evidence-based program outcomes are affected by modifications is a significant concern in the implementation of interventions. The ongoing national implementation of an evidence-based HIV prevention program targeting grade 6 students in The Bahamas [Focus on Youth in The Caribbean (FOYC)] offers an opportunity to explore factors associated with teachers' modification of FOYC lessons and to examine the impact of types and degrees of modifications on student outcomes. Data were collected in 2012 from 155 teachers and 3646 students in 77 government elementary schools. Results indicate that teachers taught 16 of 30 core activities, 24.5 of 46 total activities and 4.7 of 8 sessions. Over one-half of the teachers made modifications to FOYC core activities; one-fourth of the teachers modified 25 % or more core activities that they taught (heavily modified FOYC). Omitting core activities was the most common content modification, followed by lengthening FOYC lessons with reading, writing assignments or role-play games, and shortening core activities or adding educational videos. Mixed-effects modeling revealed that omitting core activities had negative impacts on all four student outcomes. Shortening core activities and adding videos into lessons had negative impacts on HIV/AIDS knowledge and/or intention to use condom protection. Heavy modifications (>1/4 core activities) were associated with diminished program effectiveness. Heavy modifications and omitting or shortening core activities were negatively related to teachers' level of implementation. We conclude that poorer student outcomes were associated with heavy modifications.

Core-core and core-valence correlation

NASA Technical Reports Server (NTRS)

Bauschlicher, Charles W., Jr.; Langhoff, Stephen R.; Taylor, Peter R.

1988-01-01

The effect of (1s) core correlation on properties and energy separations was analyzed using full configuration-interaction (FCI) calculations. The Be 1 S - 1 P, the C 3 P - 5 S and CH+ 1 Sigma + or - 1 Pi separations, and CH+ spectroscopic constants, dipole moment and 1 Sigma + - 1 Pi transition dipole moment were studied. The results of the FCI calculations are compared to those obtained using approximate methods. In addition, the generation of atomic natural orbital (ANO) basis sets, as a method for contracting a primitive basis set for both valence and core correlation, is discussed. When both core-core and core-valence correlation are included in the calculation, no suitable truncated CI approach consistently reproduces the FCI, and contraction of the basis set is very difficult. If the (nearly constant) core-core correlation is eliminated, and only the core-valence correlation is included, CASSCF/MRCI approached reproduce the FCI results and basis set contraction is significantly easier.

Validation of the Italian version of the Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM).

PubMed

Palmieri, Gaspare; Evans, Chris; Hansen, Vidje; Brancaleoni, Greta; Ferrari, Silvia; Porcelli, Piero; Reitano, Francesco; Rigatelli, Marco

2009-01-01

The Clinical Outcomes in Routine Evaluation--Outcome Measure (CORE-OM) was translated into Italian and tested in non-clinical (n = 263) and clinical (n = 647) samples. The translation showed good acceptability, internal consistency and convergent validity in both samples. There were large and statistically significant differences between clinical and non-clinical datasets on all scores. The reliable change criteria were similar to those for the UK referential data. Some of the clinically significant change criteria, particularly for the men, were moderately different from the UK cutting points. The Italian version of the CORE-OM showed respectable psychometric parameters. However, it seemed plausible that non-clinical and clinical distributions of self-report scores on psychopathology and functioning measures may differ by language and culture. *A good quality Italian translation of the CORE-OM, and hence the GP-CORE, CORE-10 and CORE-5 measures also, is now available for use by practitioners and anyone surveying or exploring general psychological state. The measures can be obtained from CORE-IMS or yourself and practitioners are encouraged to share anonymised data so that good clinical and non-clinical referential databases can be established for Italy.

Outcomes mapping study for childhood vaccination communication: too few concepts were measured in too many ways.

PubMed

Kaufman, Jessica; Ryan, Rebecca; Bosch-Capblanch, Xavier; Cartier, Yuri; Cliff, Julie; Glenton, Claire; Lewin, Simon; Rada, Gabriel; Ames, Heather; Muloliwa, Artur Manuel; Oku, Afiong; Oyo-Ita, Angela; Hill, Sophie

2016-04-01

The objectives of this article are to (1) comprehensively catalog outcomes measured in trials of childhood vaccination communication interventions and (2) analyze patterns and trends in outcome selection. To achieve these objectives, we developed a Trial Outcomes Map for vaccination communication. We searched the Cochrane Central Register of Controlled Trials for trials of childhood vaccination communication interventions, extracting verbatim all outcome information from included trials. Through thematic grouping, we categorized outcomes based on conceptual similarities, forming a Trial Outcomes Map. We identified 112 relevant trials containing 209 outcomes. Thematic analysis revealed three overarching Outcome Categories: consumer-, vaccination-, and health system-related outcomes. These categories contain 21 Outcome Types (eg, "knowledge," "cost"), measured using 66 different Outcome Variables. Vaccination outcomes were measured most frequently and health system-related outcomes least frequently. Consumer outcomes are increasingly measured in more recent trials. The number of measures used for the same outcomes complicates data synthesis and interpretation. Despite recent trends toward including consumer outcomes, intermediate outcome measurement is lacking, hampering understanding of how and why vaccination communication interventions do or do not work. This Map may improve outcome consistency in future trials and will contribute to a forthcoming core outcome set. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Identifying core nursing sensitive outcomes associated with the most frequently used North American Nursing Diagnosis Association-International nursing diagnoses for patients with cerebrovascular disease in Korea.

PubMed

Lee, Eunjoo; Park, Hyejin; Whyte, James; Kim, Youngae; Park, Sang Youn

2014-12-01

The purpose of this study was to identify the core nursing sensitive outcomes according to the most frequently used five North American Nursing Diagnosis Association-International for patients with cerebrovascular disease using the Nursing Outcomes Classification (NOC). A cross-sectional survey design was used. First, nursing problems were identified through 78 charts review, and then linkages between each of nursing problems and nursing sensitive outcomes were established and validated by an expert group for questionnaires. Second, 80 nurses working in the neurosurgical intensive care unit and neurosurgery departments of five Korean hospitals were asked to evaluate how important each outcome is and how often each outcome used to evaluate patient outcomes using 5-point Likert scale. Although there were some differences in the core outcomes identified for each of the nursing problem, consciousness, cognitive orientation, neurologic status and communication were considered the most critical nursing sensitive outcomes for patients suffering cerebrovascular disease. Core nursing sensitive outcomes of patients suffering cerebrovascular disease using NOC were identified to measure the effectiveness of nursing care. © 2013 Wiley Publishing Asia Pty Ltd.

Comparison of subjective and objective assessments of outcome after traumatic brain injury using the International Classification of Functioning, Disability and Health (ICF).

PubMed

Koskinen, Sanna; Hokkinen, Eeva-Maija; Wilson, Lindsay; Sarajuuri, Jaana; Von Steinbüchel, Nicole; Truelle, Jean-Luc

2011-01-01

The aim is to examine two aspects of outcome after traumatic brain injury (TBI). Functional outcome was assessed by the Glasgow Outcome Scale - Extended (GOSE) and by clinician ratings, while health-related quality of life (HRQoL) was assessed by the Quality of Life after Brain Injury (QOLIBRI). The GOSE and the QOLIBRI were linked to the International Classification of Functioning, Disability and Health (ICF) to analyse their content. Functional outcome on ICF categories was assessed by rehabilitation clinicians in 55 participants with TBI and was compared to the participants' own judgements of their HRQoL. The QOLIBRI was linked to 42 and the GOSE to 57 two-level ICF categories covering 78% of the categories on the ICF brief core set for TBI. The closest agreement in the views of the professionals and the participants was found on the Physical Problems and Cognition scales of the QOLIBRI. The problems encountered after TBI are well covered by the QOLIBRI and the GOSE. They capture important domains that are not traditionally sufficiently documented, especially in the domains of interpersonal relationships, social and leisure activities, self and the environment. The findings indicate that they are useful and complementary outcome measures for TBI. In rehabilitation, they can serve as tools in assessment, setting meaningful goals and creating therapeutic alliance.

A Common Set of Core Values - The Foundation for a More Effective Joint Force

DTIC Science & Technology

2015-05-18

these codes stopped short of codifying a set of core values and instead focused on right and wrong behaviors. This adherence to sets of rules and...Armed Forces independently recognized the limitations of compliance-based rules and the criticality of establishing a strong foundation with core...institutional values vice core values? The knee -jerk reaction of the 1990s and a subsequent lack of a formal effort to institute a single set of core

Remembering what could have happened: Neural correlates of episodic counterfactual thinking

PubMed Central

De Brigard, F; Addis, D.R.; Ford, J.H.; Schacter, D.L.; Giovanello, K.S

2014-01-01

Recent evidence suggests that our capacities to remember the past and to imagine what might happen in the future largely depend on the same core brain network that includes the middle temporal lobe, the posterior cingulate/retrosplenial cortex, the inferior parietal lobe, the medial prefrontal cortex, and the lateral temporal cortex. However, the extent to which regions of this core brain network are also responsible for our capacity to think about what could have happened in our past, yet did not occur (i.e., episodic counterfactual thinking), is still unknown. The present study examined this issue. Using a variation of the experimental recombination paradigm (Addis et al., 2009), participants were asked both to remember personal past events and to envision alternative outcomes to such events while undergoing functional magnetic resonance imaging. Three sets of analyses were performed on the imaging data in order to investigate two related issues. First, a mean-centered spatiotemporal partial least square (PLS) analysis identified a pattern of brain activity across regions of the core network that was common to episodic memory and episodic counterfactual thinking. Second, a non-rotated PLS analysis identified two different patterns of brain activity for likely and unlikely episodic counterfactual thoughts, with the former showing significant overlap with the set of regions engaged during episodic recollection. Finally, a parametric modulation was conducted to explore the differential engagement of brain regions during counterfactual thinking, revealing that areas such as the parahippocampal gyrus and the right hippocampus were modulated by the subjective likelihood of counterfactual simulations. These results suggest that episodic counterfactual thinking engages regions that form the core brain network, and also that the subjective likelihood of our counterfactual thoughts modulates the engagement of different areas within this set of regions. PMID:23376052

Report from the fourth international consensus meeting to harmonize core outcome measures for atopic eczema/dermatitis clinical trials (HOME initiative).

PubMed

Chalmers, J R; Simpson, E; Apfelbacher, C J; Thomas, K S; von Kobyletzki, L; Schmitt, J; Singh, J A; Svensson, Å; Williams, H C; Abuabara, K; Aoki, V; Ardeleanu, M; Awici-Rasmussen, M; Barbarot, S; Berents, T L; Block, J; Bragg, A; Burton, T; Bjerring Clemmensen, K K; Creswell-Melville, A; Dinesen, M; Drucker, A; Eckert, L; Flohr, C; Garg, M; Gerbens, L A A; Graff, A L B; Hanifin, J; Heinl, D; Humphreys, R; Ishii, H A; Kataoka, Y; Leshem, Y A; Marquort, B; Massuel, M-A; Merhand, S; Mizutani, H; Murota, H; Murrell, D F; Nakahara, T; Nasr, I; Nograles, K; Ohya, Y; Osterloh, I; Pander, J; Prinsen, C; Purkins, L; Ridd, M; Sach, T; Schuttelaar, M-L A; Shindo, S; Smirnova, J; Sulzer, A; Synnøve Gjerde, E; Takaoka, R; Vestby Talmo, H; Tauber, M; Torchet, F; Volke, A; Wahlgren, C-F; Weidinger, S; Weisshaar, E; Wollenberg, A; Yamaga, K; Zhao, C Y; Spuls, P I

2016-07-01

This article is a report of the fourth meeting of the Harmonising Outcome Measures for Eczema (HOME) initiative held in Malmö, Sweden on 23-24 April 2015 (HOME IV). The aim of the meeting was to achieve consensus over the preferred outcome instruments for measuring patient-reported symptoms and quality of life for the HOME core outcome set for atopic eczema (AE). Following presentations, which included data from systematic reviews, consensus discussions were held in a mixture of whole group and small group discussions. Small groups were allocated a priori to ensure representation of different stakeholders and countries. Decisions were voted on using electronic keypads. For the patient-reported symptoms, the group agreed by vote that itch, sleep loss, dryness, redness/inflamed skin and irritated skin were all considered essential aspects of AE symptoms. Many instruments for capturing patient-reported symptoms were discussed [including the Patient-Oriented SCOring Atopic Dermatitis index, Patient-Oriented Eczema Measure (POEM), Self-Administered Eczema Area and Severity Index, Itch Severity Scale, Atopic Dermatitis Quickscore and the Nottingham Eczema Severity Score] and, by consensus, POEM was selected as the preferred instrument to measure patient-reported symptoms. Further work is needed to determine the reliability and measurement error of POEM. Further work is also required to establish the importance of pain/soreness and the importance of collecting information regarding the intensity of symptoms in addition to their frequency. Much of the discussion on quality of life concerned the Dermatology Life Quality Index and Quality of Life Index for Atopic Dermatitis; however, consensus on a preferred instrument for measuring this domain could not be reached. In summary, POEM is recommended as the HOME core outcome instrument for measuring AE symptoms. © 2016 The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.

Intratumoral and Intertumoral Genomic Heterogeneity of Multifocal Localized Prostate Cancer Impacts Molecular Classifications and Genomic Prognosticators

PubMed Central

Wei, Lei; Wang, Jianmin; Lampert, Erika; Schlanger, Simon; DePriest, Adam D.; Hu, Qiang; Gomez, Eduardo Cortes; Murakam, Mitsuko; Glenn, Sean T.; Conroy, Jeffrey; Morrison, Carl; Azabdaftari, Gissou; Mohler, James L.; Liu, Song; Heemers, Hannelore V.

2018-01-01

Background Next-generation sequencing is revealing genomic heterogeneity in localized prostate cancer (CaP). Incomplete sampling of CaP multiclonality has limited the implications for molecular subtyping, stratification, and systemic treatment. Objective To determine the impact of genomic and transcriptomic diversity within and among intraprostatic CaP foci on CaP molecular taxonomy, predictors of progression, and actionable therapeutic targets. Design, setting, and participants Four consecutive patients with clinically localized National Comprehensive Cancer Network intermediate- or high-risk CaP who did not receive neoadjuvant therapy underwent radical prostatectomy at Roswell Park Cancer Institute in June–July 2014. Presurgical information on CaP content and a customized tissue procurement procedure were used to isolate nonmicroscopic and noncontiguous CaP foci in radical prostatectomy specimens. Three cores were obtained from the index lesion and one core from smaller lesions. RNA and DNA were extracted simultaneously from 26 cores with ≥90% CaP content and analyzed using whole-exome sequencing, single-nucleotide polymorphism arrays, and RNA sequencing. Outcome measurements and statistical analysis Somatic mutations, copy number alternations, gene expression, gene fusions, and phylogeny were defined. The impact of genomic alterations on CaP molecular classification, gene sets measured in Oncotype DX, Prolaris, and Decipher assays, and androgen receptor activity among CaP cores was determined. Results and limitations There was considerable variability in genomic alterations among CaP cores, and between RNA- and DNA-based platforms. Heterogeneity was found in molecular grouping of individual CaP foci and the activity of gene sets underlying the assays for risk stratification and androgen receptor activity, and was validated in independent genomic data sets. Determination of the implications for clinical decision-making requires follow-up studies. Conclusions Genomic make-up varies widely among CaP foci, so care should be taken when making treatment decisions based on a single biopsy or index lesions. Patient summary We examined the molecular composition of individual cancers in a patient’s prostate. We found a lot of genetic diversity among these cancers, and concluded that information from a single cancer biopsy is not sufficient to guide treatment decisions. PMID:27451135

Feasibility of using the International Classification of Functioning, Disability and Health Core Set for evaluation of fall-related risk factors in acute rehabilitation settings.

PubMed

Huang, Shih W; Lin, Li F; Chou, Lin C; Wu, Mei J; Liao, Chun D; Liou, Tsan H

2016-04-01

Previously, we reported the use of an International Classification of Functioning (ICF) core set that can provide a holistic framework for evaluating the risk factors of falls; however, data on the feasibility of applying this core set are lacking. To investigate the feasibility of applying the fall-related ICF risk-factor core set in the case of patients in an acute-rehabilitation setting. A cross-sectional and descriptive correlational design. Acute-rehabilitation ward. A total of 273 patients who experienced fall at acute-rehabilitation ward. The data on falls were collected from the hospital's Nursing Information System (NIS) and the fall-reporting system (Adverse Event Reporting System, AERS) between 2010 and 2013. The relationship of both systems to the fall-related ICF core set was analyzed to assess the feasibility of their clinical application. We evaluated the feasibility of using the fall-related ICF risk-factor core set by using the frequency and the percentage of the fall patients in of the listed categories. The fall-related ICF risk-factor core set category b735 (muscle tone functions) exhibited a high feasibility (85.95%) for clinical application, and the category b730 (muscle power functions) covered 77.11% of the patients. The feasibility of application of the category d410 (change basic body position) was also high in the case of all fall patients (81.69%). In the acute-rehabilitation setting, the feasibility of application of the fall-related ICF risk-factor core set is high. The fall-related ICF risk-factor core set can help multidisciplinary teams develop fall-prevention strategies in acute rehabilitation wards.

What core primary health care services should be available to Australians living in rural and remote communities?

PubMed

Thomas, Susan L; Wakerman, John; Humphreys, John S

2014-08-21

Australians living in rural and remote areas experience poorer access to primary health care (PHC) and poorer health outcomes compared to metropolitan populations. Current health reform in Australia aims to ensure all Australians, regardless of where they live, have access to essential PHC services. However, at a national level policy makers and health planners lack an evidence-based set of core PHC services to assist in implementing this goal. A Delphi method was used to reach consensus on an evidence-based list of core PHC services to which all Australians should have access and their necessary support functions. Experts in rural and remote and/or Indigenous PHC, including policy-makers, academics, clinicians and consumers, were invited to consider a list of core services derived from the literature. Thirty nine experts agreed to participate. After three survey rounds there was a strong consensus (≥80% agreement) on core PHC services namely; 'care of the sick and injured', 'mental health', 'maternal/child health', 'allied health', 'sexual/reproductive health', 'rehabilitation', 'oral/dental health' and 'public health/illness prevention'; and on the PHC support functions of; 'management/governance/leadership', 'coordination', 'health infrastructure', 'quality systems', 'data systems', 'professional development' and 'community participation'. Themes emerging from qualitative data included challenges in providing equitable PHC in rural and remote areas, the importance of service coordination and diverse strategies to overcome access barriers. This study identifies a basket of PHC services that consumers in rural and remote communities can expect to access. It provides rigorously derived evidence that will contribute to a more systematic approach to PHC service planning and availability and will assist policy makers in the allocation of scarce resources necessary to improve the health outcomes of residents of rural and remote areas.

The International Classification of Functioning (ICF) core set for breast cancer from the perspective of women with the condition.

PubMed

Cooney, Marese; Galvin, Rose; Connolly, Elizabeth; Stokes, Emma

2013-05-01

The ICF Core Set for breast cancer was generated by international experts for women who have had surgery and radiation but it has not yet been validated. The objective of the study was to validate the ICF Core Set from the perspective of women with breast cancer. A qualitative focus group methodology was used. The sessions were transcribed verbatim. Meaning units were identified by two independent researchers. The agreed list was subsequently linked to ICF categories by two independent researchers according to pre-defined linking rules. Data saturation determined the number of focus groups conducted. Quality of the data analyses was assured by multiple coding and peer review. Thirty-four women participated in seven focus groups. A total of 1621 meaning units were identified which were linked to 74 of the existing 80 Core Set categories. Additional ICF categories not currently included in the Core Set were identified by the women. The validity of the Core Set was largely supported. However, some categories currently not covered by the ICF Core Set for Breast Cancer will need to be considered for inclusion if the Core Set is to reflect all women who have had treatment for breast cancer

The Effect of a Novel Movement Strategy in Decreasing ACL Risk Factors in Female Adolescent Soccer Players: A Randomized Controlled Trial

PubMed Central

Celebrini, Richard G.; Eng, Janice J.; Miller, William C.; Ekegren, Christina L.; Johnston, James D.; Depew, Thomas A.; MacIntyre, Donna L.

2015-01-01

Objective To determine the effect of a novel movement strategy incorporated within a soccer warm-up on biomechanical risk factors for ACL injury during three sport-specific movement tasks. Design Single-blind, randomized controlled clinical trial. Setting Laboratory setting. Participants 20 top-tier female teenage soccer players. Interventions Subjects were randomized to the Core Position and Control movement strategy (Core-PAC) warm-up or standard warm-up which took place prior to their regular soccer practice over a 6-week period. The Core-PAC focuses on getting the centre of mass closer to the plant foot or base of support. Main Outcome Measures Peak knee flexion angle and abduction moments during a side-hop (SH), side-cut (SC) and unanticipated side-cut (USC) task after the 6-weeks with (intervention group only) and without a reminder to use the Core-PAC strategy. Results The Core-PAC group increased peak flexion angles during the SH task (Mean difference = 6.2°, 95% CI: 1.9–10.5°, effect size = 1.01, P = 0.034) after the 6-week warm-up program without a reminder. In addition, the Core-PAC group demonstrated increased knee flexion angles for the side-cut (Mean difference = 8.5°, 95% CI: 4.8–12.2°, ES = 2.02, P = 0.001) and side-hop (Mean difference = 10.0°, 95% CI: 5.7–14.3°, ES = 1.66, P = 0.001) task after a reminder. No changes in abduction moments were found. Conclusions The results of this study suggest that the Core-PAC may be one method of modifying high-risk soccer-specific movements and can be implemented within a practical, team-based soccer warm-up. The results should be interpreted with caution due to the small sample size. PMID:24184850

Antimicrobial Stewardship in Inpatient Settings in the Asia Pacific Region: A Systematic Review and Meta-analysis.

PubMed

Honda, Hitoshi; Ohmagari, Norio; Tokuda, Yasuharu; Mattar, Caline; Warren, David K

2017-05-15

An antimicrobial stewardship program (ASP) is one of the core elements needed to optimize antimicrobial use. Although collaboration at the national level to address the importance of ASPs and antimicrobial resistance has occurred in the Asia Pacific region, hospital-level ASP implementation in this region has not been comprehensively evaluated. We conducted a systematic review and meta-analysis to assess the efficacy of ASPs in inpatient settings in the Asia Pacific region from January 2005 through March 2016. The impact of ASPs on various outcomes, including patient clinical outcomes, antimicrobial prescription outcomes, microbiological outcomes, and expenditure were assessed. Forty-six studies were included for a systematic review and meta-analysis. The pooled risk ratio for mortality from ASP before-after trials and 2-group comparative studies were 1.03 (95% confidence interval [CI], .88-1.19) and 0.69 (95% CI, .56-.86), respectively. The pooled effect size for change in overall antimicrobial and carbapenem consumption (% difference) was -9.74% (95% CI, -18.93% to -.99%) and -10.56% (95% CI, -19.99% to -3.03%), respectively. Trends toward decreases in the incidence of multidrug-resistant organisms and antimicrobial expenditure (range, 9.7%-58.1% reduction in cost in the intervention period/arm) were also observed. ASPs in inpatient settings in the Asia Pacific region appear to be safe and effective to reduce antimicrobial consumption and improve outcomes. However, given the significant variations in assessing the efficacy of ASPs, high-quality studies using standardized surveillance methodology for antimicrobial consumption and similar metrics for outcome measurement are needed to further promote antimicrobial stewardship in this region. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.

Three-dimensional coil inductor

DOEpatents

Bernhardt, Anthony F.; Malba, Vincent

2002-01-01

A three-dimensional coil inductor is disclosed. The inductor includes a substrate; a set of lower electrically conductive traces positioned on the substrate; a core placed over the lower traces; a set of side electrically conductive traces laid on the core and the lower traces; and a set of upper electrically conductive traces attached to the side traces so as to form the inductor. Fabrication of the inductor includes the steps of forming a set of lower traces on a substrate; positioning a core over the lower traces; forming a set of side traces on the core; connecting the side traces to the lower traces; forming a set of upper traces on the core; and connecting the upper traces to the side traces so as to form a coil structure.

Choosing Important Health Outcomes for Comparative Effectiveness Research: An Updated Review and Identification of Gaps.

PubMed

Gorst, Sarah L; Gargon, Elizabeth; Clarke, Mike; Smith, Valerie; Williamson, Paula R

2016-01-01

The COMET (Core Outcome Measures in Effectiveness Trials) Initiative promotes the development and application of core outcome sets (COS), including relevant studies in an online database. In order to keep the database current, an annual search of the literature is undertaken. This study aimed to update a previous systematic review, in order to identify any further studies where a COS has been developed. Furthermore, no prioritization for COS development has previously been undertaken, therefore this study also aimed to identify COS relevant to the world's most prevalent health conditions. The methods used in this updated review followed the same approach used in the original review and the previous update. A survey was also sent to the corresponding authors of COS identified for inclusion in this review, to ascertain what lessons they had learnt from developing their COS. Additionally, the COMET database was searched to identify COS that might be relevant to the conditions with the highest global prevalence. Twenty-five reports relating to 22 new studies were eligible for inclusion in the review. Further improvements were identified in relation to the description of the scope of the COS, use of the Delphi technique, and the inclusion of patient participants within the development process. Additionally, 33 published and ongoing COS were identified for 13 of the world's most prevalent conditions. The development of a reporting guideline and minimum standards should contribute towards future improvements in development and reporting of COS. This study has also described a first approach to identifying gaps in existing COS, and to priority setting in this area. Important gaps have been identified, on the basis of global burden of disease, and the development and application of COS in these areas should be considered a priority.

Comprehensively Measuring Health-Related Subjective Well-Being: Dimensionality Analysis for Improved Outcome Assessment in Health Economics.

PubMed

de Vries, Marieke; Emons, Wilco H M; Plantinga, Arnoud; Pietersma, Suzanne; van den Hout, Wilbert B; Stiggelbout, Anne M; van den Akker-van Marle, M Elske

2016-01-01

Allocation of inevitably limited financial resources for health care requires assessment of an intervention's effectiveness. Interventions likely affect quality of life (QOL) more broadly than is measurable with commonly used health-related QOL utility scales. In line with the World Health Organization's definition of health, a recent Delphi procedure showed that assessment needs to put more emphasis on mental and social dimensions. To identify the core dimensions of health-related subjective well-being (HR-SWB) for a new, more comprehensive outcome measure. We formulated items for each domain of an initial Delphi-based set of 21 domains of HR-SWB. We tested these items in a large sample (N = 1143) and used dimensionality analyses to find a smaller number of latent factors. Exploratory factor analysis suggested a five-factor model, which explained 65% of the total variance. Factors related to physical independence, positive affect, negative affect, autonomy, and personal growth. Correlations between the factors ranged from 0.19 to 0.59. A closer inspection of the factors revealed an overlap between the newly identified core dimensions of HR-SWB and the validation scales, but the dimensions of HR-SWB also seemed to reflect additional aspects. This shows that the dimensions of HR-SWB we identified go beyond the existing health-related QOL instruments. We identified a set of five key dimensions to be included in a new, comprehensive measure of HR-SWB that reliably captures these dimensions and fills in the gaps of the existent measures used in economic evaluations. Copyright © 2016 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Recommendations for a Core Outcome Set for Measuring Standing Balance in Adult Populations: A Consensus-Based Approach

PubMed Central

Sibley, Kathryn M.; Howe, Tracey; Lamb, Sarah E.; Lord, Stephen R.; Maki, Brian E.; Rose, Debra J.; Scott, Vicky; Stathokostas, Liza; Straus, Sharon E.; Jaglal, Susan B.

2015-01-01

Background Standing balance is imperative for mobility and avoiding falls. Use of an excessive number of standing balance measures has limited the synthesis of balance intervention data and hampered consistent clinical practice. Objective To develop recommendations for a core outcome set (COS) of standing balance measures for research and practice among adults. Methodology A combination of scoping reviews, literature appraisal, anonymous voting and face-to-face meetings with fourteen invited experts from a range of disciplines with international recognition in balance measurement and falls prevention. Consensus was sought over three rounds using pre-established criteria. Data sources The scoping review identified 56 existing standing balance measures validated in adult populations with evidence of use in the past five years, and these were considered for inclusion in the COS. Results Fifteen measures were excluded after the first round of scoring and a further 36 after round two. Five measures were considered in round three. Two measures reached consensus for recommendation, and the expert panel recommended that at a minimum, either the Berg Balance Scale or Mini Balance Evaluation Systems Test be used when measuring standing balance in adult populations. Limitations Inclusion of two measures in the COS may increase the feasibility of potential uptake, but poses challenges for data synthesis. Adoption of the standing balance COS does not constitute a comprehensive balance assessment for any population, and users should include additional validated measures as appropriate. Conclusions The absence of a gold standard for measuring standing balance has contributed to the proliferation of outcome measures. These recommendations represent an important first step towards greater standardization in the assessment and measurement of this critical skill and will inform clinical research and practice internationally. PMID:25768435

Developing an interdisciplinary and cross-sectoral community of practice in the domain of forests and livelihoods.

PubMed

Watkins, Cristy; Zavaleta, Jennifer; Wilson, Sarah; Francisco, Scott

2018-02-01

Although significant resources are being spent researching and fostering the relationship between forests and livelihoods to promote mutually beneficial outcomes, critical gaps in understanding persist. A core reason for such gaps is that researchers, practitioners, and policy makers lack the structured space to interact and collaborate, which is essential for effective, interdisciplinary research, practice, and evaluation. Thus, scientific findings, policy recommendations, and measured outcomes have not always been synthesized into deep, systemic understanding; learning from practice and implementation does not easily find its way into scientific analyses, and science often fails to influence policy. Communities of practice (CofPs) are dynamic sociocultural systems that bring people together to share and create knowledge around a common topic of interest. They offer participants a space and structure within which to develop new, systemic approaches to multidimensional problems on a common theme. Uniquely informed by a systems-thinking perspective and drawing from the scientific and gray literatures and in-depth interviews with representatives of established CofPs in the natural resource management and development domain, we argue that a well-designed and adequately funded CofP can facilitate interdisciplinary and cross-sectoral relationships and knowledge exchange. Well-designed CofPs integrate a set of core features and processes to enhance individual, collective, and domain outcomes; they set out an initial but evolving purpose, encourage diverse leadership, and promote collective-identity development. Funding facilitates effective communication strategies (e.g., in person meetings). We urge our colleagues across sectors and disciplines to take advantage of CofPs to advance the domain of forests and livelihoods. © 2017 Society for Conservation Biology.

From data to wisdom: quality improvement strategies supporting large-scale implementation of evidence-based services.

PubMed

Daleiden, Eric L; Chorpita, Bruce F

2005-04-01

The Hawaii Department of Health Child and Adolescent Mental Health Division has explored various strategies to promote widespread use of empirical evidence to improve the quality of services and outcomes for youth. This article describes a core set of clinical decisions and how several general and local evidence bases may inform those decisions. Multiple quality improvement strategies are illustrated in the context of a model that outlines four phases of evidence: data, information, knowledge, and wisdom.

Relationships between core factors of knowledge management in hospital nursing organisations and outcomes of nursing performance.

PubMed

Lee, Eun Ju; Kim, Hong Soon; Kim, Hye Young

2014-12-01

The study was conducted to investigate the levels of implementation of knowledge management and outcomes of nursing performance, to examine the relationships between core knowledge management factors and nursing performance outcomes and to identify core knowledge management factors affecting these outcomes. Effective knowledge management is very important to achieve strong organisational performance. The success or failure of knowledge management depends on how effectively an organisation's members share and use their knowledge. Because knowledge management plays a key role in enhancing nursing performance, identifying the core factors and investigating the level of knowledge management in a given hospital are priorities to ensure a high quality of nursing for patients. The study employed a descriptive research procedure. The study sample consisted of 192 nurses registered in three large healthcare organisations in South Korea. The variables demographic characteristics, implementation of core knowledge management factors and outcomes of nursing performance were examined and analysed in this study. The relationships between the core knowledge management factors and outcomes of nursing performance as well as the factors affecting the performance outcomes were investigated. A knowledge-sharing culture and organisational learning were found to be core factors affecting nursing performance. The study results provide basic data that can be used to formulate effective knowledge management strategies for enhancing nursing performance in hospital nursing organisations. In particular, prioritising the adoption of a knowledge-sharing culture and organisational learning in knowledge management systems might be one method for organisations to more effectively manage their knowledge resources and thus to enhance the outcomes of nursing performance and achieve greater business competitiveness. The study results can contribute to the development of effective and efficient knowledge management systems and strategies for enhancing knowledge-sharing culture and organisational learning that can improve both the productivity and competitiveness of healthcare organisations. © 2014 John Wiley & Sons Ltd.

Core Competencies for Doctoral Education in Public Health

PubMed Central

Calhoun, Judith G.; Weist, Elizabeth M.; Raczynski, James M.

2012-01-01

The Association of Schools of Public Health (ASPH) released the Doctor of Public Health (DrPH) Core Competency Model in 2009. Between 2007 and 2009, a national expert panel with members of the academic and practice communities guided by the ASPH Education Committee developed its 7 performance domains, including 54 competencies. We provide an overview and analysis of the challenges and issues associated with the variability in DrPH degree offerings, reflect on the model development process and related outcomes, and discuss the significance of the model, future applications, and challenges for integration across educational settings. With the model, ASPH aims to stimulate national discussion on the competencies needed by DrPH graduates with the new challenges of 21st-century public health practice and to better define the DrPH degree. PMID:22095342

Developing comprehensive and Brief ICF core sets for morbid obesity for disability assessment in Taiwan: a preliminary study.

PubMed

Lin, Y-N; Chang, K-H; Lin, C-Y; Hsu, M-I; Chen, H-C; Chen, H-H; Liou, T-H

2014-04-01

The International Classification of Functioning, Disability, and Health (ICF) provides a framework for measuring functioning and disability based on a biopsychosocial model. The aim of this study was to develop comprehensive and brief ICF core sets for morbid obesity for disability assessment in Taiwan. Observational Other Twenty-nine multidisciplinary experts of ICF METHODS: The questionnaire contained 112 obesity-relevant and second-level ICF categories. Using a 5-point Likert scale, the participants rated the significance of the effects of each category on the heath status of people with obesity. Correlation between an individual's score and the average score of the group indicated consensus. The categories were selected for the comprehensive core set for obesity if more than 50% of the experts rated them as "important" in the third round of the Delphi exercise, and for the brief core set if more than 80% of the experts rated them "very important." Twenty-nine experts participated in the study. These included 18 physicians, 4 dieticians, 3 physical therapists, 2 nurses, and 2 ICF experts. The comprehensive core set for morbid obesity contained 61 categories. Of these, 26 categories were from the component body function, 8 were from body structure, 18 were from activities and participation, and 9 were from environmental factors. The brief core set for obesity disability contained 29 categories. Of these, 19 categories were from the component body function, 3 were from body structure, 6 were from activities and participation, and one was from environmental factors. The comprehensive and brief ICF core sets provide comprehensive information on the health effects of morbid obesity and concise information for clinical practice. Comprehensive and brief core sets were created after three rounds of Delphi technique. Further validation study of these core sets by applying to patients with morbid obesity is needed. The comprehensive ICF core set for morbid obesity provides comprehensive information on the health effects of morbid obesity; the brief core set can provide concise information for clinical practice.

[Can ICF core sets be helpful in preparing a social-medical expert report due to incapacity to work?--a first proposal].

PubMed

Kirschneck, M; Legner, R; Armbrust, W; Nowak, D; Cieza, A

2015-04-01

Social-medical expert reports from the German statutory pension insurance are essential for the German statutory pension regulatory authority to decide whether to grant services regarding participation as well as retirement pensions due to incapacity to work.The objective of this investigation is to determine whether the ICF Core Sets and other international approaches, such as the EUMASS Core Sets or ICF Core Set for vocational rehabilitation cover the content of the social-medical expert reports as well as to propose an approach how the ICF can be economically used by the social medicine practitioner when writing a social-medical expert report. A retrospective quantitative study design was used to translate a total of 294 social-medical expert reports from patients with low back pain (LBP) or chronic widespread pain (CWP) into the language of the ICF (linking) by 2 independent health professionals and compare the results with the ICF Core Sets for specific health conditions and other international approaches. The content of social-medical expert reports was largely reflected by the condition specific brief ICF Core Sets, brief ICF Core Sets for vocational rehabilitation and EUMASS Core Sets. The weighted Kappa statistic for the agreement between the 2 health professionals who translated the expert reports were in CWP 0.69 with a bootstrapped confidence interval of 0.67-0.71 and in LBP 0.73 (0.71-0.74). The analyses show that the content of social-medical expert reports varies enormously. A combination of a condition specific brief ICF Core Set as well as vocational rehabilitation and EUMASS ICF Core Sets as well as all ICF-categories from the expert reports that were named at least in 50% of it can largely provide a basis for preparing expert reports. Within the scope of implementation the need for a specific ICF Core Set for expert reports of the German statutory pension insurance should be further analyzed and discussed. © Georg Thieme Verlag KG Stuttgart · New York.

Using core competencies to build an evaluative framework: outcome assessment of the University of Guelph Master of Public Health program.

PubMed

Britten, Nicole; Wallar, Lauren E; McEwen, Scott A; Papadopoulos, Andrew

2014-07-31

Master of Public Health programs have been developed across Canada in response to the need for graduate-level trained professionals to work in the public health sector. The University of Guelph recently conducted a five-year outcome assessment using the Core Competencies for Public Health in Canada as an evaluative framework to determine whether graduates are receiving adequate training, and identify areas for improvement. A curriculum map of core courses and an online survey of University of Guelph Master of Public Health graduates comprised the outcome assessment. The curriculum map was constructed by evaluating course outlines, assignments, and content to determine the extent to which the Core Competencies were covered in each course. Quantitative survey results were characterized using descriptive statistics. Qualitative survey results were analyzed to identify common themes and patterns in open-ended responses. The University of Guelph Master of Public Health program provided a positive learning environment in which graduates gained proficiency across the Core Competencies through core and elective courses, meaningful practicums, and competent faculty. Practice-based learning environments, particularly in collaboration with public health organizations, were deemed to be beneficial to students' learning experiences. The Core Competencies and graduate surveys can be used to conduct a meaningful and informative outcome assessment. We encourage other Master of Public Health programs to conduct their own outcome assessments using a similar framework, and disseminate these results in order to identify best practices and strengthen the Canadian graduate public health education system.

Strengthening of the Hip and Core Versus Knee Muscles for the Treatment of Patellofemoral Pain: A Multicenter Randomized Controlled Trial

PubMed Central

Ferber, Reed; Bolgla, Lori; Earl-Boehm, Jennifer E.; Emery, Carolyn; Hamstra-Wright, Karrie

2015-01-01

Context: Patellofemoral pain (PFP) is the most common injury in running and jumping athletes. Randomized controlled trials suggest that incorporating hip and core strengthening (HIP) with knee-focused rehabilitation (KNEE) improves PFP outcomes. However, no randomized controlled trials have, to our knowledge, directly compared HIP and KNEE programs. Objective: To compare PFP pain, function, hip- and knee-muscle strength, and core endurance between KNEE and HIP protocols after 6 weeks of rehabilitation. We hypothesized greater improvements in (1) pain and function, (2) hip strength and core endurance for patients with PFP involved in the HIP protocol, and (3) knee strength for patients involved in the KNEE protocol. Design: Randomized controlled clinical trial. Setting: Four clinical research laboratories in Calgary, Alberta; Chicago, Illinois; Milwaukee, Wisconsin; and Augusta, Georgia. Patients or Other Participants: Of 721 patients with PFP screened, 199 (27.6%) met the inclusion criteria (66 men [31.2%], 133 women [66.8%], age = 29.0 ± 7.1 years, height = 170.4 ± 9.4 cm, weight = 67.6 ± 13.5 kg). Intervention(s): Patients with PFP were randomly assigned to a 6-week KNEE or HIP protocol. Main Outcome Measure(s): Primary variables were self-reported visual analog scale and Anterior Knee Pain Scale measures, which were conducted weekly. Secondary variables were muscle strength and core endurance measured at baseline and at 6 weeks. Results: Compared with baseline, both the visual analog scale and the Anterior Knee Pain Scale improved for patients with PFP in both the HIP and KNEE protocols (P < .001), but the visual analog scale scores for those in the HIP protocol were reduced 1 week earlier than in the KNEE group. Both groups increased in strength (P < .001), but those in the HIP protocol gained more in hip-abductor (P = .01) and -extensor (P = .01) strength and posterior core endurance (P = .05) compared with the KNEE group. Conclusions: Both the HIP and KNEE rehabilitation protocols produced improvements in PFP, function, and strength over 6 weeks. Although outcomes were similar, the HIP protocol resulted in earlier resolution of pain and greater overall gains in strength compared with the KNEE protocol. PMID:25365133

Standardised assessment of functioning in ADHD: consensus on the ICF Core Sets for ADHD.

PubMed

Bölte, Sven; Mahdi, Soheil; Coghill, David; Gau, Susan Shur-Fen; Granlund, Mats; Holtmann, Martin; Karande, Sunil; Levy, Florence; Rohde, Luis A; Segerer, Wolfgang; de Vries, Petrus J; Selb, Melissa

2018-02-12

Attention-deficit/hyperactivity disorder (ADHD) is associated with significant impairments in social, educational, and occupational functioning, as well as specific strengths. Currently, there is no internationally accepted standard to assess the functioning of individuals with ADHD. WHO's International Classification of Functioning, Disability and Health-child and youth version (ICF) can serve as a conceptual basis for such a standard. The objective of this study is to develop a comprehensive, a common brief, and three age-appropriate brief ICF Core Sets for ADHD. Using a standardised methodology, four international preparatory studies generated 132 second-level ICF candidate categories that served as the basis for developing ADHD Core Sets. Using these categories and following an iterative consensus process, 20 ADHD experts from nine professional disciplines and representing all six WHO regions selected the most relevant categories to constitute the ADHD Core Sets. The consensus process resulted in 72 second-level ICF categories forming the comprehensive ICF Core Set-these represented 8 body functions, 35 activities and participation, and 29 environmental categories. A Common Brief Core Set that included 38 categories was also defined. Age-specific brief Core Sets included a 47 category preschool version for 0-5 years old, a 55 category school-age version for 6-16 years old, and a 52 category version for older adolescents and adults 17 years old and above. The ICF Core Sets for ADHD mark a milestone toward an internationally standardised functional assessment of ADHD across the lifespan, and across educational, administrative, clinical, and research settings.

Self-reflection, growth goals, and academic outcomes: A qualitative study.

PubMed

Travers, Cheryl J; Morisano, Dominique; Locke, Edwin A

2015-06-01

Goal-setting theory continues to be among the most popular and influential theories of motivation and performance, although there have been limited academic applications relative to applications in other domains, such as organizational psychology. This paper summarizes existing quantitative research and then employs a qualitative approach to exploring academic growth via an in-depth reflective growth goal-setting methodology. The study focuses on 92 UK final-year students enrolled in an elective advanced interpersonal skills and personal development module, with self-reflection and growth goal setting at its core. Qualitative data in the form of regular reflective written diary entries and qualitative questionnaires were collected from students during, on completion of, and 6 months following the personal growth goal-setting programme. About 20% of students' self-set growth goals directly related to academic growth and performance; students reported that these had a strong impact on their achievement both during and following the reflective programme. Growth goals that were indirectly related to achievement (e.g., stress management) appeared to positively impact academic growth and other outcomes (e.g., well-being). A follow-up survey revealed that growth goal setting continued to impact academic growth factors (e.g., self-efficacy, academic performance) beyond the reflective programme itself. Academic growth can result from both academically direct and indirect growth goals, and growth goal setting appears to be aided by the process of simultaneous growth reflection. The implications for promoting academic growth via this unique learning and development approach are discussed. © 2014 The British Psychological Society.

The Health Promoting Schools Framework: Known Unknowns and an Agenda for Future Research.

PubMed

Langford, Rebecca; Bonell, Christopher; Komro, Kelli; Murphy, Simon; Magnus, Daniel; Waters, Elizabeth; Gibbs, Lisa; Campbell, Rona

2017-06-01

The World Health Organization's Health Promoting Schools (HPS) framework is a whole-school approach to promoting health that recognizes the intrinsic relationship between health and education. Our recent Cochrane systematic review found HPS interventions produced improvements in a number of student health outcomes. Here we reflect on what this review was not able to tell us: in other words, what evidence is missing with regard to the HPS approach. Few HPS interventions engage with schools' "core business" by examining impacts on educational outcomes. Current evidence is dominated by obesity interventions, with most studies conducted with children rather than adolescents. Evidence is lacking for outcomes such as mental or sexual health, substance use, and violence. Activities to engage families and communities are currently weak and unlikely to prompt behavioral change. The HPS approach is largely absent in low-income settings, despite its potential in meeting children's basic health needs. Intervention theories are insufficiently complex, often ignoring upstream determinants of health. Few studies provide evidence on intervention sustainability or cost-effectiveness, nor in-depth contextual or process data. We set out an agenda for future school health promotion research, considering implications for key stakeholders, namely, national governments, research funders, academics, and schools.

The Social Determinants of Health Core: Taking a Place-Based Approach.

PubMed

Scribner, Richard A; Simonsen, Neal R; Leonardi, Claudia

2017-01-01

There is growing recognition that health disparities research needs to incorporate social determinants in the local environment into explanatory models. In the transdisciplinary setting of the Mid-South Transdisciplinary Collaborative Center (TCC), the Social Determinants of Health (SDH) Core developed an approach to incorporating SDH across a variety of studies. This place-based approach, which is geographically based, transdisciplinary, and inherently multilevel, is discussed. From 2014 through 2016, the SDH Core consulted on a variety of Mid-South TCC research studies with the goal of incorporating social determinants into their research designs. The approach used geospatial methods (e.g., geocoding) to link individual data files with measures of the physical and social environment in the SDH Core database. Once linked, the method permitted various types of analysis (e.g., multilevel analysis) to determine if racial disparities could be explained in terms of social determinants in the local environment. The SDH Core consulted on five Mid-South TCC research projects. In resulting analyses for all the studies, a significant portion of the variance in one or more outcomes was partially explained by a social determinant from the SDH Core database. The SDH Core approach to addressing health disparities by linking neighborhood social and physical environment measures to an individual-level data file proved to be a successful approach across Mid-South TCC research projects. Copyright © 2016 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

A method to assess obstetric outcomes using the 10-Group Classification System: a quantitative descriptive study

PubMed Central

Rossen, Janne; Lucovnik, Miha; Eggebø, Torbjørn Moe; Tul, Natasa; Murphy, Martina; Vistad, Ingvild; Robson, Michael

2017-01-01

Objectives Internationally, the 10-Group Classification System (TGCS) has been used to report caesarean section rates, but analysis of other outcomes is also recommended. We now aim to present the TGCS as a method to assess outcomes of labour and delivery using routine collection of perinatal information. Design This research is a methodological study to describe the use of the TGCS. Setting Stavanger University Hospital (SUH), Norway, National Maternity Hospital Dublin, Ireland and Slovenian National Perinatal Database (SLO), Slovenia. Participants 9848 women from SUH, Norway, 9250 women from National Maternity Hospital Dublin, Ireland and 106 167 women, from SLO, Slovenia. Main outcome measures All women were classified according to the TGCS within which caesarean section, oxytocin augmentation, epidural analgesia, operative vaginal deliveries, episiotomy, sphincter rupture, postpartum haemorrhage, blood transfusion, maternal age >35 years, body mass index >30, Apgar score, umbilical cord pH, hypoxic–ischaemic encephalopathy, antepartum and perinatal deaths were incorporated. Results There were significant differences in the sizes of the groups of women and the incidences of events and outcomes within the TGCS between the three perinatal databases. Conclusions The TGCS is a standardised objective classification system where events and outcomes of labour and delivery can be incorporated. Obstetric core events and outcomes should be agreed and defined to set standards of care. This method provides continuous and available observations from delivery wards, possibly used for further interpretation, questions and international comparisons. The definition of quality may vary in different units and can only be ascertained when all the necessary information is available and considered together. PMID:28706102

A high-resolution transcriptome map of cell cycle reveals novel connections between periodic genes and cancer

PubMed Central

Dominguez, Daniel; Tsai, Yi-Hsuan; Gomez, Nicholas; Jha, Deepak Kumar; Davis, Ian; Wang, Zefeng

2016-01-01

Progression through the cell cycle is largely dependent on waves of periodic gene expression, and the regulatory networks for these transcriptome dynamics have emerged as critical points of vulnerability in various aspects of tumor biology. Through RNA-sequencing of human cells during two continuous cell cycles (>2.3 billion paired reads), we identified over 1 000 mRNAs, non-coding RNAs and pseudogenes with periodic expression. Periodic transcripts are enriched in functions related to DNA metabolism, mitosis, and DNA damage response, indicating these genes likely represent putative cell cycle regulators. Using our set of periodic genes, we developed a new approach termed “mitotic trait” that can classify primary tumors and normal tissues by their transcriptome similarity to different cell cycle stages. By analyzing >4 000 tumor samples in The Cancer Genome Atlas (TCGA) and other expression data sets, we found that mitotic trait significantly correlates with genetic alterations, tumor subtype and, notably, patient survival. We further defined a core set of 67 genes with robust periodic expression in multiple cell types. Proteins encoded by these genes function as major hubs of protein-protein interaction and are mostly required for cell cycle progression. The core genes also have unique chromatin features including increased levels of CTCF/RAD21 binding and H3K36me3. Loss of these features in uterine and kidney cancers is associated with altered expression of the core 67 genes. Our study suggests new chromatin-associated mechanisms for periodic gene regulation and offers a predictor of cancer patient outcomes. PMID:27364684

Core Competencies in Integrative Pain Care for Entry-Level Primary Care Physicians.

PubMed

Tick, Heather; Chauvin, Sheila W; Brown, Michael; Haramati, Aviad

2015-11-01

The objective was to develop a set of core competencies for graduating primary care physicians in integrative pain care (IPC), using the Accreditation Council for Graduate Medical Education (ACGME) domains. These competencies build on previous work in competencies for integrative medicine, interprofessional education, and pain medicine and are proposed for inclusion in residency training. A task force was formed to include representation from various professionals who are involved in education, research, and the practice of IPC and who represent broad areas of expertise. The task force convened during a 1.5-day face-to-face meeting, followed by a series of surveys and other vetting processes involving diverse interprofessional groups, which led to the consensus of a final set of competencies. The proposed competencies focus on interprofessional knowledge, skills, and attitudes (KSAs) and are in line with recommendations by the Institute of Medicine, military medicine, and professional pain societies advocating the need for coordination and integration of services for effective pain care with reduced risk and cost and improved outcomes. These ACGME domain compatible competencies for physicians reflect the contributions of several disciplines that will need to be included in evolving interprofessional settings and underscore the need for collaborative care. These core competencies can guide the incorporation of KSAs within curricula. The learning experiences should enable medical educators and graduating primary care physicians to focus more on integrative approaches, interprofessional team-based, patient-centered care that use evidence-based, traditional and complementary disciplines and therapeutics to provide safe and effective treatments for people in pain. Wiley Periodicals, Inc.

APPLES TO APPLES OR APPLES TO ORANGES? INTERNATIONAL VARIATION IN REPORTING OF PROCESS AND OUTCOME OF CARE FOR OUT-OF-HOSPITAL CARDIAC ARREST

PubMed Central

Nishiyama, Chika; Brown, Siobhan P; May, Susanne J; Iwami, Taku; Koster, Rudolph W.; Beesems, Stefanie G.; Kuisma, Markku; Salo, Ari; Jacobs, Ian; Finn, Judith; Sterz, Fritz; Nürnberger, Alexander; Smith, Karen; Morrison, Laurie; Olasveengen, Theresa M.; Callaway, Clifton W.; Shin, Sang Do; Gräsner, Jan-Thorsten; Daya, Mohamud; Ma, Matthew Huei-Ming; Herlitz, Johan; Strömsöe, Anneli; Aufderheide, Tom P.; Masterson, Siobhán; Wang, Henry; Christenson, Jim; Stiell, Ian; Davis, Dan; Huszti, Ella; Nichol, Graham

2014-01-01

Objectives Survival after out-of-hospital cardiac arrest (OHCA) varies between communities, due in part to variation in the methods of measurement. The Utstein template was disseminated to standardize comparisons of risk factors, quality of care and outcomes in patients with OHCA. We sought to assess whether OHCA registries are able to collate common data using the Utstein template. A subsequent study will assess whether the Utstein factors explain differences in survival between emergency medical services (EMS) systems. Study design Retrospective study. Setting This retrospective analysis of prospective cohorts included adults treated for OHCA, regardless of the etiology of arrest. Data describing the baseline characteristics of patients, and the process and outcome of their care were grouped by EMS system, de-identified then collated. Included were core Utstein variables and timed event data from each participating registry. This study was classified as exempt from human subjects’ research by a research ethics committee. Measurements and Main Results Twelve registries with 265 first-responding EMS agencies in 14 countries contributed data describing 125,840 cases of OHCA. Variation in inclusion criteria, definition, coding, and process of care variables were observed. Contributing registries collected 61.9% of recommended core variables and 42.9% of timed event variables. Among core variables, the proportion of missingness was mean 1.9 ± 2.2%. The proportion of unknown was mean 4.8 ± 6.4%. Among time variables, missingness was mean 9.0 ± 6.3%. Conclusions International differences in measurement of care after OHCA persist. Greater consistency would facilitate improved resuscitation care and comparison within and between communities. PMID:25010784

Core Temperature and Sweat Responses in Professional Women's Tennis Players During Tournament Play in the Heat

PubMed Central

Tippet, Melissa L.; Stofan, John R.; Lacambra, Magie; Horswill, Craig A.

2011-01-01

Abstract Context: Tennis is often played in hot, humid environments, intensifying the thermoregulatory strain placed on the athletes. As a safety measure, some tennis organizations allow for a 10-minute break in play between the second and third sets when environmental conditions are extreme. However, the actual effect of these breaks in reducing core temperature is unknown. Objective: To determine change in core temperature after a 10-minute break in play and assess fluid balance in professional female tennis players during tournament matches in the heat. Design: Cross-sectional study. Setting: A Women's Tennis Association Tour–sanctioned outdoor tournament on hard courts under hot conditions (30.3°C ± 2.3°C). Patients or Other Participants: Seven professional tennis players. Main Outcome Measure(s): Change in core temperature after a 10-minute break in tournament play, fluid intake, and sweat losses during match play. Results: Core temperature was reduced from 38.92°C to 38.67°C (change of −0.25°C ± 0.20°C) when a break was taken (P  =  .02). Mean sweat rate during match play was 2.0 ± 0.5 L/h. During that time, mean fluid intake was 1.5 ± 0.5 L/h, resulting in a 1.2% ± 1.0% reduction in body mass. Conclusions: Female professional tennis players are subjected to high heat loads during match play in hot environments. However, a 10-minute break in play decreased core temperature in 6 of 7 players by an average of 0.25°C, indicating that the break provides practical benefits in the field. Furthermore, although mean sweat rate in this group of female tennis players was high, most athletes were still able to minimize mass loss to less than 2% of their prematch weight. PMID:21214351

Validation of the Comprehensive ICF Core Set for obstructive pulmonary diseases from the patient's perspective.

PubMed

Marques, Alda; Jácome, Cristina; Gonçalves, Ana; Silva, Sara; Lucas, Carla; Cruz, Joana; Gabriel, Raquel

2014-06-01

This study aimed to validate the Comprehensive International Classification of Functioning, Disability and Health (ICF) Core Set for obstructive pulmonary diseases (OPDs) from the perspective of patients with chronic obstructive pulmonary disease. A cross-sectional qualitative study was carried out with outpatients with chronic obstructive pulmonary disease using focus groups with an ICF-based approach. Qualitative data were analysed using the meaning condensation procedure by two researchers with expertise in the ICF. Thirty-two participants (37.5% women; 63.8 ± 11.3 years old) were included in six focus groups. A total of 61 (86%) ICF categories of the Comprehensive ICF Core Set for OPD were confirmed. Thirty-nine additional second-level categories not included in the Core Set were identified: 15 from the body functions component, four from the body structures, nine from the activities and participation and 11 from the environmental factors. The majority of the categories included in the Comprehensive ICF Core Set for OPD were confirmed from the patients' perspective. However, additional categories, not included in the Core Set, were also reported. The categories included in the Core Set were not confirmed and the additional categories need to be investigated further to develop an instrument tailored to patients' needs. This will promote patient-centred assessments and rehabilitation interventions.

Beyond diagnosis: the Core Sets for persons with schizophrenia based on the World Health Organization's International Classification of Functioning, Disability, and Health.

PubMed

Gómez-Benito, Juana; Guilera, Georgina; Barrios, Maite; Rojo, Emilio; Pino, Oscar; Gorostiaga, Arantxa; Balluerka, Nekane; Hidalgo, María Dolores; Padilla, José Luis; Benítez, Isabel; Selb, Melissa

2017-07-30

Based on the International Classification of Functioning, Disability and Health (ICF), this paper presents the results of the process to develop the Comprehensive and Brief Core Sets for schizophrenia that allow to comprehensively describe functioning in persons with schizophrenia. Twenty health professionals from diverse backgrounds participated in a formal and iterative decision-making process during an international consensus conference to develop these Core Sets. The conference was carried out based on evidence gathered from four preparatory studies (systematic literature review, qualitative study, expert survey, and empirical study). The first step of this decision-making and consensus process comprised of discussions and voting in working groups and plenary sessions to develop the comprehensive version. The categories of the Comprehensive ICF Core Set for schizophrenia served as the basis for the second step -a ranking and cutoff procedure to decide on the brief version. Of the 184 candidate categories identified in the preparatory studies, 97 categories were included in the Comprehensive Core Set for schizophrenia. A total of 25 categories were selected to constitute the Brief Core Set. The formal decision-making and consensus process integrating evidence from four preparatory studies and expert opinion led to the first version of the Core Sets for schizophrenia. Comprehensive and Brief Core Sets for schizophrenia may provide a common language among different health professionals and researchers, and a basic international standard of what to measure, report, and assess the functioning of persons with schizophrenia. Implications for rehabilitation Schizophrenia is a chronic mental disorder that has a tremendous impact on functioning and daily life of persons living with the disorder. The International Classification of Functioning, Disability and Health (ICF) offers an internationally recognized standard for describing the functioning status of these individuals. The Core Sets for schizophrenia have potential use in supporting rehabilitation practice such as for planning mental health services and other interventions or defining rehabilitation goals, and documenting patient care. The Core Sets for schizophrenia may also be used to promote interdisciplinary coordination and facilitate communication between members of a multidisciplinary rehabilitation team. Rehabilitation research is another potential area of application of the Core Sets for schizophrenia. This is valuable, since rehabilitation research provides crucial evidence for optimizing rehabilitation practice.

Characteristics of Pediatric Antimicrobial Stewardship Programs: Current Status of the Sharing Antimicrobial Reports for Pediatric Stewardship (SHARPS) Collaborative

PubMed Central

McPherson, Christopher; Lee, Brian R.; Terrill, Cindy; Hersh, Adam L.; Gerber, Jeffrey S.; Kronman, Matthew P.; Newland, Jason G.

2018-01-01

In response to the growing epidemic of antibiotic-resistant bacterial infections, antimicrobial stewardship programs (ASP) have been rapidly implemented in the United States (US). This study examines the prevalence of the Centers for Disease Control and Prevention’s (CDC) seven core elements of a successful ASP within a large subset of US Children’s Hospitals. In 2016, a survey was conducted of 52 pediatric hospitals assessing the presence of the seven core elements: leadership commitment, accountability, drug expertise, action, tracking, reporting, and education. Forty-nine hospitals (94%) had established ASPs and 41 hospitals (79%) included all seven core elements. Physician accountability (87%) and a dedicated ASP pharmacist or drug expert (88%) were present in the vast majority of hospitals. However, substantial variability existed in the financial support allotted to these positions. This variability did not predict program actions, tracking, reporting, and education. When compared with previous surveys, these results document a dramatic increase in the prevalence and resources of pediatric stewardship programs, although continued expansion is warranted. Further research is required to understand the feasibility of various core stewardship activities and the impact on patient outcomes in the setting of finite resources. PMID:29370071

Characteristics of Pediatric Antimicrobial Stewardship Programs: Current Status of the Sharing Antimicrobial Reports for Pediatric Stewardship (SHARPS) Collaborative.

PubMed

McPherson, Christopher; Lee, Brian R; Terrill, Cindy; Hersh, Adam L; Gerber, Jeffrey S; Kronman, Matthew P; Newland, Jason G

2018-01-25

In response to the growing epidemic of antibiotic-resistant bacterial infections, antimicrobial stewardship programs (ASP) have been rapidly implemented in the United States (US). This study examines the prevalence of the Centers for Disease Control and Prevention's (CDC) seven core elements of a successful ASP within a large subset of US Children's Hospitals. In 2016, a survey was conducted of 52 pediatric hospitals assessing the presence of the seven core elements: leadership commitment, accountability, drug expertise, action, tracking, reporting, and education. Forty-nine hospitals (94%) had established ASPs and 41 hospitals (79%) included all seven core elements. Physician accountability (87%) and a dedicated ASP pharmacist or drug expert (88%) were present in the vast majority of hospitals. However, substantial variability existed in the financial support allotted to these positions. This variability did not predict program actions, tracking, reporting, and education. When compared with previous surveys, these results document a dramatic increase in the prevalence and resources of pediatric stewardship programs, although continued expansion is warranted. Further research is required to understand the feasibility of various core stewardship activities and the impact on patient outcomes in the setting of finite resources.

Using core competencies to build an evaluative framework: outcome assessment of the University of Guelph Master of Public Health program

PubMed Central

2014-01-01

Background Master of Public Health programs have been developed across Canada in response to the need for graduate-level trained professionals to work in the public health sector. The University of Guelph recently conducted a five-year outcome assessment using the Core Competencies for Public Health in Canada as an evaluative framework to determine whether graduates are receiving adequate training, and identify areas for improvement. Methods A curriculum map of core courses and an online survey of University of Guelph Master of Public Health graduates comprised the outcome assessment. The curriculum map was constructed by evaluating course outlines, assignments, and content to determine the extent to which the Core Competencies were covered in each course. Quantitative survey results were characterized using descriptive statistics. Qualitative survey results were analyzed to identify common themes and patterns in open-ended responses. Results The University of Guelph Master of Public Health program provided a positive learning environment in which graduates gained proficiency across the Core Competencies through core and elective courses, meaningful practicums, and competent faculty. Practice-based learning environments, particularly in collaboration with public health organizations, were deemed to be beneficial to students’ learning experiences. Conclusions The Core Competencies and graduate surveys can be used to conduct a meaningful and informative outcome assessment. We encourage other Master of Public Health programs to conduct their own outcome assessments using a similar framework, and disseminate these results in order to identify best practices and strengthen the Canadian graduate public health education system. PMID:25078124

Pharmacists' interventions on clinical asthma outcomes: a systematic review.

PubMed

Garcia-Cardenas, Victoria; Armour, Carol; Benrimoj, Shalom I; Martinez-Martinez, Fernando; Rotta, Inajara; Fernandez-Llimos, Fernando

2016-04-01

The objective of this systematic review was to evaluate the impact of pharmacists' interventions on clinical asthma outcomes on adult patients and to identify the outcome indicators used.PubMed, Scopus, Web of Science and Scielo were searched. Studies addressing pharmacists' interventions on adult asthma patients reporting clinical asthma outcomes were incorporated.11 clinical outcomes were identified in 21 studies. 10 studies measured the impact of the intervention on asthma control. Randomised controlled trials (RCT) and non-RCTs found positive results in percentages of controlled patients and Asthma Control Questionnaire (ACQ) scores. Discordant results were found for Asthma Control Test results. Asthma severity was assessed in four studies. One RCT found a significant decrease in the percentage of severe patients; two non-RCTs found significant improvements in severity scores. 11 studies reported pulmonary function indicators, showing inconsistent results. Eight studies measured asthma symptoms; three RCTs and four non-RCTs showed significant improvements.RCTs and non-RCTs generated similar results for most outcomes. Based on the evidence generated by RCTs, pharmacists' have a positive impact on the percentage of controlled patients, ACQ scores, severity and symptoms. Future research should report using the core outcome set of indicators established for asthma (PROSPERO CRD42014007019). Copyright ©ERS 2016.

Mapping the rehabilitation interventions of a community stroke team to the extended International Classification of Functioning, Disability and Health Core Set for Stroke.

PubMed

Evans, Melissa; Hocking, Clare; Kersten, Paula

2017-12-01

This study aim was to evaluate whether the Extended International Classification of Functioning, Disability and Health Core Set for Stroke captured the interventions of a community stroke rehabilitation team situated in a large city in New Zealand. It was proposed that the results would identify the contribution of each discipline, and the gaps and differences in service provision to Māori and non-Māori. Applying the Extended International Classification of Functioning, Disability and Health Core Set for Stroke in this way would also inform whether this core set should be adopted in New Zealand. Interventions were retrospectively extracted from 18 medical records and linked to the International Classification of Functioning, Disability and Health and the Extended International Classification of Functioning, Disability and Health Core Set for Stroke. The frequencies of linked interventions and the health discipline providing the intervention were calculated. Analysis revealed that 98.8% of interventions provided by the rehabilitation team could be linked to the Extended International Classification of Functioning, Disability and Health Core Set for Stroke, with more interventions for body function and structure than for activities and participation; no interventions for emotional concerns; and limited interventions for community, social and civic life. Results support previous recommendations for additions to the EICSS. The results support the use of the Extended International Classification of Functioning, Disability and Health Core Set for Stroke in New Zealand and demonstrates its use as a quality assurance tool that can evaluate the scope and practice of a rehabilitation service. Implications for Rehabilitation The Extended International Classification of Functioning Disability and Health Core Set for Stroke appears to represent the stroke interventions of a community stroke rehabilitation team in New Zealand. As a result, researchers and clinicians may have increased confidence to use this core set in research and clinical practice. The Extended International Classification of Functioning Disability and Health Core Set for Stroke can be used as a quality assurance tool to establish whether a community stroke rehabilitation team is meeting the functional needs of its stroke population.

Content validation of the international classification of functioning, disability and health core set for stroke from gender perspective using a qualitative approach.

PubMed

Glässel, A; Coenen, M; Kollerits, B; Cieza, A

2014-06-01

The extended ICF Core Set for stroke is an application of the International Classification of Functioning, Disability and Health (ICF) of the World Health Organisation (WHO) with the purpose to represent the typical spectrum of functioning of persons with stroke. The objective of the study is to add evidence to the content validity of the extended ICF Core Set for stroke from persons after stroke taking into account gender perspective. A qualitative study design was conducted by using individual interviews with women and men after stroke in an in- and outpatient rehabilitation setting. The sampling followed the maximum variation strategy. Sample size was determined by saturation. Concepts from qualitative data analysis were linked to ICF categories and compared to the extended ICF Core Set for stroke. Twelve women and 12 men participated in 24 individual interviews. In total, 143 out of 166 ICF categories included in the extended ICF Core Set for stroke were confirmed (women: N.=13; men: N.=17; both genders: N.=113). Thirty-eight additional categories that are not yet included in the extended ICF Core Set for stroke were raised by women and men. This study confirms that the experience of functioning and disability after stroke shows communalities and differences for women and men. The validity of the extended ICF Core Set for stroke could be mostly confirmed, since it does not only include those areas of functioning and disability relevant to both genders but also those exclusively relevant to either women or men. Further research is needed on ICF categories not yet included in the extended ICF Core Set for stroke.

Project (inverted exclamation mark)EXITO!: success through diversity and universality for outcomes improvement among Hispanic home care patients.

PubMed

Woerner, Louise; Espinosa, Javier; Bourne, Susan; O'Toole, Marie; Ingersoll, Gail L

2009-01-01

The National Health Disparities Report notes that Hispanics have poorer quality of care in 23 of 38 core measures. The result of this disparity is great personal and health system costs, which could be reduced. Prior studies have focused on access and language. We studied outcomes improvement. The purpose of this project was to develop a replicable theory-based outcomes improvement model for delivery of nursing care to Hispanic patients. The Leininger Sunrise Enabler approach was used to design a program specific to the cultural needs of a home care population. Outcome and Assessment Information Set (OASIS) data from 125 unduplicated home care patients were tracked. Nursing care delivery was analyzed using ethnographic research techniques. Delivery of nursing care using a culturally congruent approach reduced acute hospitalization and emergent care visits. Medication management and customer and nursing satisfaction also improved. National standards for culturally and linguistically appropriate services in health care help reduce healthcare disparities, but improving Hispanic outcomes requires moving beyond symptoms and symptom management to transcultural care. The estimated savings to the health care system are significant.

Trial outcomes and information for clinical decision-making: a comparative study of opinions of health professionals.

PubMed

McNair, Angus G K; Brookes, Sara T; Whistance, Robert N; Forsythe, Rachael O; Macefield, Rhiannon; Rees, Jonathan; Jones, James; Smith, George; Pullyblank, Anne M; Avery, Kerry N L; Thomas, Michael G; Sylvester, Paul A; Russell, Anne; Oliver, Alfred; Morton, Dion; Kennedy, Robin; Jayne, David G; Huxtable, Richard; Hackett, Rowland; Dutton, Susan J; Coleman, Mark G; Card, Mia; Brown, Julia; Blazeby, Jane M

2016-07-25

Trials are robust sources of data for clinical practice; however, trial outcomes may not reflect what is important to communicate for decision-making. The study compared clinicians' views of outcomes to include in a core outcome set for colorectal cancer (CRC) surgery, with what clinicians considered important information for clinical practice (core information). Potential outcome/information domains were identified through systematic literature reviews, reviews of hospital information leaflets and interviews with patients. These were organized into six categories and used to design a questionnaire survey that asked surgeons and nurses from a sample of CRC centers to rate the importance of each domain as an outcome or as information on a nine-point Likert scale. Respondents were re-surveyed (round 2) following group feedback (Delphi methods). Comparisons were made by calculating the difference in mean scores between the outcomes and information domains, and paired t tests were used to explore the difference between mean scores of the six outcome/information categories. Data sources identified 1216 outcome/information items for CRC surgery that informed a 94-item questionnaire. First-round questionnaires were returned from 63/81 (78 %) of centers. Clinicians rated 76/94 (84 %) domains of higher importance to measure in trials than information to communicate to patients in round 1. This was reduced to 24/47 (51 %) in round 2. The greatest difference was evident in domains regarding survival, which was rated much more highly as a trial outcome than an important piece of information for decision-making (difference in mean 2.3, 95 % CI 1.9 to 2.8, p <0.0001). Specific complications and quality-of-life domains were rated similarly (difference in mean 0.18, 95 % CI -0.1 to 0.4, p = 0.2 and difference in mean 0.2, 95 % CI -0.1 to 0.5, p = 0.2, respectively). Whilst clinicians want to measure key outcomes in trials, they rate these as less important to communicate in decision-making with patients. This discrepancy needs to be explored and addressed to maximize the impact of trials on clinical practice.

The CROWN initiative: journal editors invite researchers to develop core outcomes in women’s health

PubMed Central

2014-01-01

Clinical trials, systematic reviews and guidelines compare beneficial and non-beneficial outcomes following interventions. Often, however, various studies on a particular topic do not address the same outcomes, making it difficult to draw clinically useful conclusions when a group of studies is looked at as a whole. This problem was recently thrown into sharp focus by a systematic review of interventions for preterm birth prevention, which found that among 103 randomised trials, no fewer than 72 different outcomes were reported. There is a growing recognition among clinical researchers that this variability undermines consistent synthesis of the evidence, and that what is needed is an agreed standardised collection of outcomes - a “core outcomes set” - for all trials in a specific clinical area. Recognising that the current inconsistency is a serious hindrance to progress in our specialty, the editors of over 50 journals related to women’s health have come together to support The CROWN (CoRe Outcomes in WomeN’s health) Initiative. PMID:24957208

Development of the International Classification of Functioning, Disability and Health core sets for hand conditions--results of the World Health Organization International Consensus process.

PubMed

Rudolf, Klaus-Dieter; Kus, Sandra; Chung, Kevin C; Johnston, Marie; LeBlanc, Monique; Cieza, Alarcos

2012-01-01

A formal decision-making and consensus process was applied to develop the first version of the International Classification on Functioning, Disability and Health (ICF) Core Sets for Hand Conditions. To convene an international panel to develop the ICF Core Sets for Hand Conditions (HC), preparatory studies were conducted, which included an expert survey, a systematic literature review, a qualitative study and an empirical data collection process involving persons with hand conditions. A consensus conference was convened in Switzerland in May 2009 that was attended by 23 healthcare professionals, who treat hand conditions, representing 22 countries. The preparatory studies identified a set of 743 ICF categories at the second, third or fourth hierarchical level. Altogether, 117 chapter-, second-, or third-level categories were included in the comprehensive ICF Core Set for HC. The brief ICF Core Set for HC included a total of 23 chapter- and second-level categories. A formal consensus process integrating evidence and expert opinion based on the ICF led to the formal adoption of the ICF Core Sets for Hand Conditions. The next phase of this ICF project is to conduct a formal validation process to establish its applicability in clinical settings.

Spent Fuel Test-Climax: core logging for site investigation and instrumentation

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

Wilder, D.G.; Yow, J.L. Jr.; Thorpe, R.K.

1982-05-28

As an integral part of the Spent Fuel Test-Climax 5150 ft (1570 m) of granite core was obtained. This core was diamond drilled in various sizes, mainly 38-mm and 76-mm diameters. The core was teken with single tube core barrels and was unoriented. Techniques used to drill and log this core are discussed, as well as techniques to orient the core. Of the 5150 ft (1570 m) of core more than 3645 ft (1111 m) was retained and logged in some detail. As a result of the core logging, geologic discontinuities were identified, joint frequency and spacing characterized. Discontinuities identifiedmore » included several joint sets, shear zones and faults. Correlations based on coring along were generally found to be impossible, even for the more prominent features. The only feature properly correlated from the exploratory drilling was the fault system at the end of the facility, but it was not identified from the exploratory core as a fault. Identification of discontinuities was later helped by underground mapping that identified several different joint sets with different characteristics. It was found that joint frequency varied from 0.3 to 1.1 joint per foot of core for open fractures and from 0.3 to 3.3/ft for closed or healed fractures. Histograms of fracture spacing indicate that there is likely a random distribution of spacing superimposed upon uniformly spaced fractures. It was found that a low angle joint set had a persistent mean orientation. These joints were healed and had pervasive wall rock alteration which made identification of joints in this set possible. The recognition of a joint set with known attitude allowed orientation of much of the core. This orientation technique was found to be effective. 10 references, 25 figures, 4 tables.« less

Choosing outcome assessment tools in haemophilia care and research: a multidisciplinary perspective.

PubMed

Fischer, K; Poonnoose, P; Dunn, A L; Babyn, P; Manco-Johnson, M J; David, J A; van der Net, J; Feldman, B; Berger, K; Carcao, M; de Kleijn, P; Silva, M; Hilliard, P; Doria, A; Srivastava, A; Blanchette, V

2017-01-01

The implementation of early long-term, regular clotting factor concentrate (CFC) replacement therapy ('prophylaxis') has made it possible to offer boys with haemophilia a near normal life. Many different regimens have reported favourable results, but the optimum treatment regimens have not been established and the cost of prophylaxis is very high. Both for optimizing treatment and reimbursement issues, there is a need to provide objective evidence of both short- and long-term results and benefits of prophylactic regimens. This report presents a critical review of outcome measures for use in the assessment of musculoskeletal health in persons with haemophilia according to the International Classification of Functioning, Disability and Health (ICF). This framework considers structural and functional changes, activities and participation in a context of both personal and environmental factors. Results were generated by a combination of a critical review of available literature plus expert opinion derived from a two day consensus conference between 48 health care experts from different disciplines involved in haemophilia assessment and care. Outcome tools used in haemophilia were reviewed for reliability and validity in different patient groups and for resources required. Recommendations for choice of outcome tools were made according to the ICF domains, economic setting, and reason for use (clinical or research). The next step will be to identify a 'core' set of outcome measures for use in clinical care or studies evaluating treatment. © 2016 The Authors. Haemophilia Published by John Wiley & Sons Ltd.

The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) and how to select an outcome measurement instrument.

PubMed

Mokkink, Lidwine B; Prinsen, Cecilia A C; Bouter, Lex M; Vet, Henrica C W de; Terwee, Caroline B

2016-01-19

COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) is an initiative of an international multidisciplinary team of researchers who aim to improve the selection of outcome measurement instruments both in research and in clinical practice by developing tools for selecting the most appropriate available instrument. In this paper these tools are described, i.e. the COSMIN taxonomy and definition of measurement properties; the COSMIN checklist to evaluate the methodological quality of studies on measurement properties; a search filter for finding studies on measurement properties; a protocol for systematic reviews of outcome measurement instruments; a database of systematic reviews of outcome measurement instruments; and a guideline for selecting outcome measurement instruments for Core Outcome Sets in clinical trials. Currently, we are updating the COSMIN checklist, particularly the standards for content validity studies. Also new standards for studies using Item Response Theory methods will be developed. Additionally, in the future we want to develop standards for studies on the quality of non-patient reported outcome measures, such as clinician-reported outcomes and performance-based outcomes. In summary, we plea for more standardization in the use of outcome measurement instruments, for conducting high quality systematic reviews on measurement instruments in which the best available outcome measurement instrument is recommended, and for stopping the use of poor outcome measurement instruments.

The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) and how to select an outcome measurement instrument

PubMed Central

Mokkink, Lidwine B.; Prinsen, Cecilia A. C.; Bouter, Lex M.; de Vet, Henrica C. W.; Terwee, Caroline B.

2016-01-01

Background: COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) is an initiative of an international multidisciplinary team of researchers who aim to improve the selection of outcome measurement instruments both in research and in clinical practice by developing tools for selecting the most appropriate available instrument. Method: In this paper these tools are described, i.e. the COSMIN taxonomy and definition of measurement properties; the COSMIN checklist to evaluate the methodological quality of studies on measurement properties; a search filter for finding studies on measurement properties; a protocol for systematic reviews of outcome measurement instruments; a database of systematic reviews of outcome measurement instruments; and a guideline for selecting outcome measurement instruments for Core Outcome Sets in clinical trials. Currently, we are updating the COSMIN checklist, particularly the standards for content validity studies. Also new standards for studies using Item Response Theory methods will be developed. Additionally, in the future we want to develop standards for studies on the quality of non-patient reported outcome measures, such as clinician-reported outcomes and performance-based outcomes. Conclusions: In summary, we plea for more standardization in the use of outcome measurement instruments, for conducting high quality systematic reviews on measurement instruments in which the best available outcome measurement instrument is recommended, and for stopping the use of poor outcome measurement instruments. PMID:26786084

Basis sets for the calculation of core-electron binding energies

NASA Astrophysics Data System (ADS)

Hanson-Heine, Magnus W. D.; George, Michael W.; Besley, Nicholas A.

2018-05-01

Core-electron binding energies (CEBEs) computed within a Δ self-consistent field approach require large basis sets to achieve convergence with respect to the basis set limit. It is shown that supplementing a basis set with basis functions from the corresponding basis set for the element with the next highest nuclear charge (Z + 1) provides basis sets that give CEBEs close to the basis set limit. This simple procedure provides relatively small basis sets that are well suited for calculations where the description of a core-ionised state is important, such as time-dependent density functional theory calculations of X-ray emission spectroscopy.

Identification of preliminary core outcome domains for communication about childhood vaccination: An online Delphi survey.

PubMed

Kaufman, Jessica; Ryan, Rebecca; Lewin, Simon; Bosch-Capblanch, Xavier; Glenton, Claire; Cliff, Julie; Oyo-Ita, Angela; Muloliwa, Artur Manuel; Oku, Afiong; Ames, Heather; Rada, Gabriel; Cartier, Yuri; Hill, Sophie

2017-08-20

Communication interventions for childhood vaccination are promising strategies to address vaccine hesitancy, but current research is limited by the outcomes measured. Most studies measure only vaccination-related outcomes, with minimal consideration of vaccine hesitancy-relevant intermediate outcomes. This impedes understanding of which interventions or elements are effective. It is also unknown which outcomes are important to the range of stakeholders affected by vaccine hesitancy. Outcome selection shapes the evidence base, informing future interventions and trials, and should reflect stakeholder priorities. Therefore, our aim was to identify which outcome domains (i.e. broad outcome categories) are most important to different stakeholders, identifying preliminary core outcome domains to inform evaluation of three common vaccination communication types: (i) communication to inform or educate, (ii) remind or recall, and (iii) enhance community ownership. We conducted a two-stage online Delphi survey, involving four stakeholder groups: parents or community members, healthcare providers, researchers, and government or non-governmental organisation representatives. Participants rated the importance of eight outcome domains for each of the three communication types. They also rated specific outcomes within one domain ("attitudes or beliefs") and provided feedback about the survey. Collectively, stakeholder groups prioritised outcome domains differently when considering the effects of different communication types. For communication that aims to (i) inform or educate, the most important outcome domain is "knowledge or understanding"; for (ii) reminder communication, "vaccination status and behaviours"; and for (iii) community engagement communication, "community participation". All stakeholder groups rated most outcome domains as very important or critical. The highest rated specific outcome within the "attitudes or beliefs" domain was "trust". This Delphi survey expands the field of core outcomes research and identifies preliminary core outcome domains for measuring the effects of communication about childhood vaccination. The findings support the argument that vaccination communication is not a single homogenous intervention - it has a range of purposes, and vaccination communication evaluators should select outcomes accordingly. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

Value of Computed Tomographic Perfusion-Based Patient Selection for Intra-Arterial Acute Ischemic Stroke Treatment.

PubMed

Borst, Jordi; Berkhemer, Olvert A; Roos, Yvo B W E M; van Bavel, Ed; van Zwam, Wim H; van Oostenbrugge, Robert J; van Walderveen, Marianne A A; Lingsma, Hester F; van der Lugt, Aad; Dippel, Diederik W J; Yoo, Albert J; Marquering, Henk A; Majoie, Charles B L M

2015-12-01

The utility of computed tomographic perfusion (CTP)-based patient selection for intra-arterial treatment of acute ischemic stroke has not been proven in randomized trials and requires further study in a cohort that was not selected based on CTP. Our objective was to study the relationship between CTP-derived parameters and outcome and treatment effect in patients with acute ischemic stroke because of a proximal intracranial arterial occlusion. We included 175 patients who underwent CTP in the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in The Netherlands (MR CLEAN). Association of CTP-derived parameters (ischemic-core volume, penumbra volume, and percentage ischemic core) with outcome was estimated with multivariable ordinal logistic regression as an adjusted odds ratio for a shift in the direction of a better outcome on the modified Rankin Scale. Interaction between CTP-derived parameters and treatment effect was determined using multivariable ordinal logistic regression. Interaction with treatment effect was also tested for mismatch (core <70 mL; penumbra core >1.2; penumbra core >10 mL). The adjusted odds ratio for improved functional outcome for ischemic core, percentage ischemic core, and penumbra were 0.79 per 10 mL (95% confidence interval: 0.71-0.89; P<0.001), 0.82 per 10% (95% confidence interval: 0.66-0.90; P=0.002), and 0.97 per 10 mL (96% confidence interval: 0.92-1.01; P=0.15), respectively. No significant interaction between any of the CTP-derived parameters and treatment effect was observed. We observed no significant interaction between mismatch and treatment effect. CTP seems useful for predicting functional outcome, but cannot reliably identify patients who will not benefit from intra-arterial therapy. © 2015 American Heart Association, Inc.

Fission control system for nuclear reactor

DOEpatents

Conley, G.H.; Estes, G.P.

Control system for nuclear reactor comprises a first set of reactivity modifying rods fixed in a reactor core with their upper ends stepped in height across the core, and a second set of reactivity modifying rods movable vertically within the reactor core and having their lower ends stepped to correspond with the stepped arrangement of the first set of rods, pairs of the rods of the first and second sets being in coaxial alignment.

Wide-neck bifurcation aneurysms of the middle cerebral artery and basilar apex treated by endovascular techniques: a multicentre, core lab adjudicated study evaluating safety and durability of occlusion (BRANCH).

PubMed

De Leacy, Reade A; Fargen, Kyle M; Mascitelli, Justin R; Fifi, Johanna; Turkheimer, Lena; Zhang, Xiangnan; Patel, Aman B; Koch, Matthew J; Pandey, Aditya S; Wilkinson, D Andrew; Griauzde, Julius; James, Robert F; Fortuny, Enzo M; Cruz, Aurora; Boulos, Alan; Nourollah-Zadeh, Emad; Paul, Alexandra; Sauvageau, Eric; Hanel, Ricardo; Aguilar-Salinas, Pedro; Novakovic, Roberta L; Welch, Babu G; Almardawi, Ranyah; Jindal, Gaurav; Shownkeen, Harish; Levy, Elad I; Siddiqui, Adnan H; Mocco, J

2018-06-01

BRANCH (wide-neck bifurcation aneurysms of the middle cerebral artery and basilar apex treated by endovascular techniques) is a multicentre, retrospective study comparing core lab evaluation of angiographic outcomes with self-reported outcomes. Consecutive patients were enrolled from 10 US centres, aged between 18 and 85 with unruptured wide-neck middle cerebral artery (MCA) or basilar apex aneurysms treated endovascularly. Patient demographics, aneurysm morphology, procedural information, mortality and morbidity data and core lab and self-reported modified Raymond Roy (RR) outcomes were obtained. 115 patients met inclusion criteria. Intervention-related mortality and significant morbidity rates were 1.7% (2/115) and 5.8% (6/103) respectively. Core lab adjudicated RR1 and 2 occlusion rates at follow-up were 30.6% and 32.4% respectively. The retreatment rate within the follow-up window was 10/115 (8.7%) and in stent stenosis at follow-up was 5/63 (7.9%). Self-reporting shows a statistically significant direction to angiographic RR one outcomes at follow-up compared with core lab evaluation, with OR 1.75 (95% CI 1.08 to 2.83). Endovascular treatment of wide-neck MCA and basilar apex aneurysms resulted in a core lab adjudicated RR1 occlusion rate of 30.6%. Self-reported results at follow-up favour better angiographic outcomes, with OR 1.75 (95% CI 1.08 to 2.83). These data demonstrate the need for novel endovascular devices specifically designed to treat complex intracranial aneurysms, as well as the importance of core lab adjudication in assessing outcomes in such a trial. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

End-of-Kindergarten Spelling Outcomes: How Can Spelling Error Analysis Data Inform Beginning Reading Instruction?

PubMed

Lee, Julia Ai Cheng; Otaiba, Stephanie Al

2017-01-01

In this article, the authors examined the spelling performance of 430 kindergarteners, which included a high risk sample, to determine the relations between end of kindergarten reading and spelling in a high quality language arts setting. The spelling outcomes including the spelling errors between the good and the poor readers were described, analyzed, and compared. The findings suggest that not all the children have acquired the desired standard as outlined by the Common Core State Standards. In addition, not every good reader is a good speller and that not every poor speller is a poor reader. The study shows that spelling tasks that are accompanied by spelling errors analysis provide a powerful window for making instructional sense of children's spelling errors and for individualizing spelling instructional strategies.

Which outcomes are most important to people with aphasia and their families? an international nominal group technique study framed within the ICF.

PubMed

Wallace, Sarah J; Worrall, Linda; Rose, Tanya; Le Dorze, Guylaine; Cruice, Madeline; Isaksen, Jytte; Kong, Anthony Pak Hin; Simmons-Mackie, Nina; Scarinci, Nerina; Gauvreau, Christine Alary

2017-07-01

To identify important treatment outcomes from the perspective of people with aphasia and their families using the ICF as a frame of reference. The nominal group technique was used with people with aphasia and their family members in seven countries to identify and rank important treatment outcomes from aphasia rehabilitation. People with aphasia identified outcomes for themselves; and family members identified outcomes for themselves and for the person with aphasia. Outcomes were analysed using qualitative content analysis and ICF linking. A total of 39 people with aphasia and 29 family members participated in one of 16 nominal groups. Inductive qualitative content analysis revealed the following six themes: (1) Improved communication; (2) Increased life participation; (3) Changed attitudes through increased awareness and education about aphasia; (4) Recovered normality; (5) Improved physical and emotional well-being; and (6) Improved health (and support) services. Prioritized outcomes for both participant groups linked to all ICF components; primary activity/participation (39%) and body functions (36%) for people with aphasia, and activity/participation (49%) and environmental factors (28%) for family members. Outcomes prioritized by family members relating to the person with aphasia, primarily linked to body functions (60%). People with aphasia and their families identified treatment outcomes which span all components of the ICF. This has implications for research outcome measurement and clinical service provision which currently focuses on the measurement of body function outcomes. The wide range of desired outcomes generated by both people with aphasia and their family members, highlights the importance of collaborative goal setting within a family-centred approach to rehabilitation. These results will be combined with other stakeholder perspectives to establish a core outcome set for aphasia treatment research. Implications for Rehabilitation Important outcomes for people with aphasia and their families span all components of the ICF. The relevancy and translation of research findings may be increased by measuring and reporting research outcomes which are important to people living with aphasia. The results of this study indicate that important treatment outcomes for people living with aphasia most frequently link to the activity/participation and body function components of the ICF. The outcomes identified in this study suggest a broad role for clinicians working in aphasia rehabilitation. The categories of identified outcomes may be used clinically as a starting point in goal-setting discussions with clients and their families.

Core-Collapse Supernovae Explored by Multi-D Boltzmann Hydrodynamic Simulations

NASA Astrophysics Data System (ADS)

Sumiyoshi, Kohsuke; Nagakura, Hiroki; Iwakami, Wakana; Furusawa, Shun; Matsufuru, Hideo; Imakura, Akira; Yamada, Shoichi

We report the latest results of numerical simulations of core-collapse supernovae by solving multi-D neutrino-radiation hydrodynamics with Boltzmann equations. One of the longstanding issues of the explosion mechanism of supernovae has been uncertainty in the approximations of the neutrino transfer in multi-D such as the diffusion approximation and ray-by-ray method. The neutrino transfer is essential, together with 2D/3D hydrodynamical instabilities, to evaluate the neutrino heating behind the shock wave for successful explosions and to predict the neutrino burst signals. We tackled this difficult problem by utilizing our solver of the 6D Boltzmann equation for neutrinos in 3D space and 3D neutrino momentum space coupled with multi-D hydrodynamics adding special and general relativistic extensions. We have performed a set of 2D core-collapse simulations from 11M ⊙ and 15M ⊙ stars on K-computer in Japan by following long-term evolution over 400 ms after bounce to reveal the outcome from the full Boltzmann hydrodynamic simulations with a sophisticated equation of state with multi-nuclear species and updated rates for electron captures on nuclei.

International Classification of Functioning, Disability and Health core set for physical health of older adults.

PubMed

Ruaro, João A; Ruaro, Marinêz B; Guerra, Ricardo O

2014-01-01

To facilitate a systematic, comprehensive description of functioning and to enable the use of the International Classification of Functioning, Disability and Health (ICF) in clinical practice and research, core sets have been developed. The aim of this study was to propose a version of the ICF core set to classify the physical health of older adults. The proposition of the ICF core set was based on the Delphi technique. The panel of experts included 8 Brazilian researchers (physical therapists, medical doctors, nurses, and physical educators). The communication was wholly electronic. In total, there were 5 rounds of interactivity between the participants to arrive at the final version of the construct. The ICF core set presented 30 categories (14 on body functions, 4 on body structures, 9 on activities or participation, and 3 on environmental factors) and had a Cronbach α of 0.964. The presented core set is a secure, fast, and accurate instrument for assessing the physical health and engagement of older adults. It defines points related to functioning and health that are relevant when evaluating this population, as well as when reevaluating it and monitoring changes.

Mapping of a standard documentation template to the ICF core sets for arthritis and low back pain.

PubMed

Escorpizo, Reuben; Davis, Kandace; Stumbo, Teri

2010-12-01

To identify the contents of a documentation template in The Guide to Physical Therapist Practice using the International Classification of Functioning, Disability, and Health (ICF) Core Sets for rheumatoid arthritis, osteoarthritis, and low back pain (LBP) as reference. Concepts were identified from items of an outpatient documentation template and mapped to the ICF using established linking rules. The ICF categories that were linked were compared with existing arthritis and LBP Core Sets. Based on the ICF, the template had the highest number (29%) of linked categories under Activities and participation while Body structures had the least (17%). ICF categories in the arthritis and LBP Core Sets had a 37-55% match with the ICF categories found in the template. We found 164 concepts that were not classified or not defined and 37 as personal factors. The arthritis and LBP Core Sets were reflected in the contents of the template. ICF categories in the Core Sets were reflected in the template (demonstrating up to 55% match). Potential integration of ICF in documentation templates could be explored and examined in the future to enhance clinical encounters and multidisciplinary communication. Copyright © 2010 John Wiley & Sons, Ltd.

Development of ICF Core Sets to standardize assessment of functioning and impairment in ADHD: the path ahead.

PubMed

Bölte, Sven; de Schipper, Elles; Holtmann, Martin; Karande, Sunil; de Vries, Petrus J; Selb, Melissa; Tannock, Rosemary

2014-12-01

In the study of health and quality of life in attention deficit/hyperactivity disorder (ADHD), it is of paramount importance to include assessment of functioning. The International Classification of Functioning, Disability and Health (ICF) provides a comprehensive, universally accepted framework for the description of functioning in relation to health conditions. In this paper, the authors outline the process to develop ICF Core Sets for ADHD. ICF Core Sets are subgroups of ICF categories selected to capture the aspects of functioning that are most likely to be affected in specific disorders. The ICF categories that will be included in the ICF Core Sets for ADHD will be determined at an ICF Core Set Consensus Conference, wherein evidence from four preliminary studies (a systematic review, an expert survey, a patient and caregiver qualitative study, and a clinical cross-sectional study) will be integrated. Comprehensive and Brief ICF Core Sets for ADHD will be developed with the goal of providing useful standards for research and clinical practice, and to generate a common language for the description of functioning in ADHD in different areas of life and across the lifespan.

The impact of the EUSCLE Core Set Questionnaire for the assessment of cutaneous lupus erythematosus.

PubMed

Kuhn, A; Patsinakidis, N; Bonsmann, G

2010-08-01

Epidemiological data and standard European guidelines for the diagnosis and treatment of cutaneous lupus erythematosus (CLE) are lacking in the current literature. In order to provide a standardized tool for an extensive consistent data collection, a study group of the European Society of Cutaneous Lupus Erythematosus (EUSCLE) recently developed a Core Set Questionnaire for the assessment of patients with different subtypes of CLE. The EUSCLE Core Set Questionnaire includes six sections on patient data, diagnosis, skin involvement, activity and damage of disease, laboratory analysis, and treatment. An instrument like the EUSCLE Core Set Questionnaire is essential to gain a broad and comparable data collection of patients with CLE from different European centres and to achieve consensus concerning clinical standards for the disease. The data will also be important for further characterization of the different CLE subtypes and the evaluation of therapeutic strategies; moreover, the EUSCLE Core Set Questionnaire might also be useful for the comparison of data in clinical trials. In this review, the impact of the EUSCLE Core Set Questionnaire is discussed in detail with regard to clinical and serological features as well as therapeutic modalities in CLE.

Diversity captured in the USDA-ARS National Plant Germplasm System apple core collection

USDA-ARS?s Scientific Manuscript database

Core collections have been used widely in genetic resources to provide a representative and compact sample to use in breeding evaluation. In the 1990s a core set was developed by the USDA-ARS Plant Genetic Resources Unit (PGRU) in Geneva, NY. Using data available at the time, a core set was develo...

Update on Outcome Measure Development for Large Vessel Vasculitis: Report from OMERACT 12

PubMed Central

Aydin, Sibel Zehra; Direskeneli, Haner; Sreih, Antoine; Alibaz-Oner, Fatma; Gul, Ahmet; Kamali, Sevil; Hatemi, Gulen; Kermani, Tanaz; Mackie, Sarah L.; Mahr, Alfred; Meara, Alexa; Milman, Nataliya; Nugent, Heidi; Robson, Joanna; Tomasson, Gunnar; Merkel, Peter A.

2015-01-01

Objective The rarity of large vessel vasculitis (LVV) is a major factor limiting randomized controlled trials in LVV, resulting in treatment choices in these diseases that are guided mainly by observational studies and expert opinion. Further complicating trials in LVV is the absence of validated and meaningful outcome measures. The Outcome Measures in Rheumatology (OMERACT) vasculitis working group initiated the Large Vessel Vasculitis task force in 2009 to develop data-driven, validated outcome tools for clinical investigation in LVV. This report summarizes the progress that has been made on a disease activity assessment tool and patient-reported outcomes in LVV as well as the group’s research agenda. Methods The OMERACT LVV task force brought an international group of investigators and patient research partners together to work collaboratively on developing outcome tools. The group initially focused on disease activity assessment tools in LVV. Following a systematic literature review, an international Delphi exercise was conducted to obtain expert opinion on principles and domains for disease assessment. The OMERACT vasculitis working group’s LVV task force is also conducting qualitative research with patients, including interviews, focus groups, and engaging patients as research partners, all to ensure that the approach to disease assessment includes measures of patients’ perspectives and that patients have input into the research agenda and process. Results The preliminary results of both the Delphi exercise and the qualitative interviews were discussed at the OMERACT 12 (2014) meeting and the completion of the analyses will produce an initial set of domains and instruments to form the basis of next steps in the research agenda. Conclusion The research agenda continues to evolve, with the ultimate goal of developing an OMERACT-endorsed core set of outcome measures for use in clinical trials of LVV. PMID:26077399

Core competencies for pharmaceutical physicians and drug development scientists

PubMed Central

Silva, Honorio; Stonier, Peter; Buhler, Fritz; Deslypere, Jean-Paul; Criscuolo, Domenico; Nell, Gerfried; Massud, Joao; Geary, Stewart; Schenk, Johanna; Kerpel-Fronius, Sandor; Koski, Greg; Clemens, Norbert; Klingmann, Ingrid; Kesselring, Gustavo; van Olden, Rudolf; Dubois, Dominique

2013-01-01

Professional groups, such as IFAPP (International Federation of Pharmaceutical Physicians and Pharmaceutical Medicine), are expected to produce the defined core competencies to orient the discipline and the academic programs for the development of future competent professionals and to advance the profession. On the other hand, PharmaTrain, an Innovative Medicines Initiative project, has become the largest public-private partnership in biomedicine in the European Continent and aims to provide postgraduate courses that are designed to meet the needs of professionals working in medicines development. A working group was formed within IFAPP including representatives from PharmaTrain, academic institutions and national member associations, with special interest and experience on Quality Improvement through education. The objectives were: to define a set of core competencies for pharmaceutical physicians and drug development scientists, to be summarized in a Statement of Competence and to benchmark and align these identified core competencies with the Learning Outcomes (LO) of the PharmaTrain Base Course. The objectives were successfully achieved. Seven domains and 60 core competencies were identified and aligned accordingly. The effective implementation of training programs using the competencies or the PharmaTrain LO anywhere in the world may transform the drug development process to an efficient and integrated process for better and safer medicines. The PharmaTrain Base Course might provide the cognitive framework to achieve the desired Statement of Competence for Pharmaceutical Physicians and Drug Development Scientists worldwide. PMID:23986704

Establishing a Core Outcome Measure for Fatigue in Patients on Hemodialysis: A Standardized Outcomes in Nephrology-Hemodialysis (SONG-HD) Consensus Workshop Report.

PubMed

Ju, Angela; Unruh, Mark; Davison, Sara; Dapueto, Juan; Dew, Mary Amanda; Fluck, Richard; Germain, Michael; Jassal, Sarbjit V; Obrador, Gregorio; O'Donoghue, Donal; Josephson, Michelle A; Craig, Jonathan C; Viecelli, Andrea; O'Lone, Emma; Hanson, Camilla S; Manns, Braden; Sautenet, Benedicte; Howell, Martin; Reddy, Bharathi; Wilkie, Caroline; Rutherford, Claudia; Tong, Allison

2018-03-15

Fatigue is one of the most highly prioritized outcomes for patients and clinicians, but remains infrequently and inconsistently reported across trials in hemodialysis. We convened an international Standardized Outcomes in Nephrology-Hemodialysis (SONG-HD) consensus workshop with stakeholders to discuss the development and implementation of a core outcome measure for fatigue. 15 patients/caregivers and 42 health professionals (clinicians, researchers, policy makers, and industry representatives) from 9 countries participated in breakout discussions. Transcripts were analyzed thematically. 4 themes for a core outcome measure emerged. Drawing attention to a distinct and all-encompassing symptom was explicitly recognizing fatigue as a multifaceted symptom unique to hemodialysis. Emphasizing the pervasive impact of fatigue on life participation justified the focus on how fatigue severely impaired the patient's ability to do usual activities. Ensuring relevance and accuracy in measuring fatigue would facilitate shared decision making about treatment. Minimizing burden of administration meant avoiding the cognitive burden, additional time, and resources required to use the measure. A core outcome measure that is simple, is short, and includes a focus on the severity of the impact of fatigue on life participation may facilitate consistent and meaningful measurement of fatigue in all trials to inform decision making and care of patients receiving hemodialysis. Copyright © 2018 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

Novel assessment tools to evaluate clinical and laboratory responses in a subset of patients enrolled in the Rituximab in Myositis trial.

PubMed

Rider, Lisa G; Yip, Adrienne L; Horkayne-Szakaly, Iren; Volochayev, Rita; Shrader, Joseph A; Turner, Maria L; Kong, Heidi H; Jain, Minal S; Jansen, Anna V; Oddis, Chester V; Fleisher, Thomas A; Miller, Frederick W

2014-01-01

We aimed to assess changes in myositis core set measures and ancillary clinical and laboratory data from the National Institutes of Health's subset of patients enrolled in the Rituximab in Myositis trial. Eighteen patients (5 dermatomyositis, 8 polymyositis, 5 juvenile dermatomyositis) completed more in-depth testing of muscle strength and cutaneous assessments, patient-reported outcomes, and laboratory tests before and after administration of rituximab. Percentage change in individual measures and in the definitions of improvement (DOIs) and standardized response means were examined over 44 weeks. Core set activity measures improved by 18-70% from weeks 0-44 and were sensitive to change. Fifteen patients met the DOI at week 44, 9 patients met a DOI 50% response, and 4 met a DOI 70% response. Muscle strength and function measures were more sensitive to change than cutaneous assessments. Constitutional, gastrointestinal, and pulmonary systems improved 44-70%. Patient-reported outcomes improved up to 28%. CD20+ B cells were depleted in the periphery, but B cell depletion was not associated with clinical improvement at week 16. This subset of patients had high rates of clinical response to rituximab, similar to patients in the overall trial. Most measures were responsive, and muscle strength had a greater degree of change than cutaneous assessments. Several novel assessment tools, including measures of strength and function, extra-muscular organ activity, fatigue, and health-related quality of life, are promising for use in future myositis trials. Further study of B cell-depleting therapies in myositis, particularly in treatment-naïve patients, is warranted.

Clinicians’ and researchers’ perspectives on establishing and implementing core outcomes in haemodialysis: semistructured interview study

PubMed Central

Tong, Allison; Crowe, Sally; Gill, John S; Harris, Tess; Hemmelgarn, Brenda R; Manns, Braden; Pecoits-Filho, Roberto; Tugwell, Peter; van Biesen, Wim; Wang, Angela Yee Moon; Wheeler, David C; Winkelmayer, Wolfgang C; Gutman, Talia; Ju, Angela; O’Lone, Emma; Sautenet, Benedicte; Viecelli, Andrea; Craig, Jonathan C

2018-01-01

Objectives To describe the perspectives of clinicians and researchers on identifying, establishing and implementing core outcomes in haemodialysis and their expected impact. Design Face-to-face, semistructured interviews; thematic analysis. Stetting Twenty-seven centres across nine countries. Participants Fifty-eight nephrologists (42 (72%) who were also triallists). Results We identified six themes: reflecting direct patient relevance and impact (survival as the primary goal of dialysis, enabling well-being and functioning, severe consequences of comorbidities and complications, indicators of treatment success, universal relevance, stakeholder consensus); amenable and responsive to interventions (realistic and possible to intervene on, differentiating between treatments); reflective of economic burden on healthcare; feasibility of implementation (clarity and consistency in definition, easily measurable, requiring minimal resources, creating a cultural shift, aversion to intensifying bureaucracy, allowing justifiable exceptions); authoritative inducement and directive (endorsement for legitimacy, necessity of buy-in from dialysis providers, incentivising uptake); instituting patient-centredness (explicitly addressing patient-important outcomes, reciprocating trial participation, improving comparability of interventions for decision-making, driving quality improvement and compelling a focus on quality of life). Conclusions Nephrologists emphasised that core outcomes should be relevant to patients, amenable to change, feasible to implement and supported by stakeholder organisations. They expected core outcomes would improve patient-centred care and outcomes. PMID:29678992

Launching forward: The integration of behavioral health in primary care as a key strategy for promoting young child wellness.

PubMed

Oppenheim, Jennifer; Stewart, Whitney; Zoubak, Ekaterina; Donato, Ingrid; Huang, Larke; Hudock, William

2016-03-01

In 2008, the Substance Abuse and Mental Health Services Administration (SAMHSA) created a national grant program, Project LAUNCH (Linking Actions for Unmet Needs in Children's Health), to improve behavioral health and developmental outcomes for young children through the incorporation of prevention and wellness promotion practices in key early childhood settings. Project LAUNCH supports states, tribal nations, and territories to improve coordination across early childhood systems and implement 5 core strategies of prevention and promotion. This article focuses on the lessons learned from 1 of the 5 core strategies: integration of behavioral health into primary care for young children. This paper analyzes the experiences of a sample of Project LAUNCH grantees, describing 10 common elements of integration approaches and exploring some of the challenges of promoting health and preventing social, emotional, and behavioral problems at a population level. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Value management: optimizing quality, service, and cost.

PubMed

Makadon, Harvey J; Bharucha, Farzan; Gavin, Michael; Oliveira, Jason; Wietecha, Mark

2010-01-01

Hospitals have wrestled with balancing quality, service, and cost for years--and the visibility and urgency around measuring and communicating real metrics has grown exponentially in the last decade. However, even today, most hospital leaders cannot articulate or demonstrate the "value" they provide to patients and payers. Instead of developing a strategic direction that is based around a core value proposition, they focus their strategic efforts on tactical decisions like physician recruitment, facility expansion, and physician alignment. In the healthcare paradigm of the next decade, alignment of various tactical initiatives will require a more coherent understanding of the hospital's core value positioning. The authors draw on their experience in a variety of healthcare settings to suggest that for most hospitals, quality (i.e., clinical outcomes and patient safety) will become the most visible indicator of value, and introduce a framework to help healthcare providers influence their value positioning based on this variable.

Outcome Measures Used in Clinical Trials for Behçet Syndrome: A Systematic Review

PubMed Central

Hatemi, Gulen; Merkel, Peter A.; Hamuryudan, Vedat; Boers, Maarten; Direskeneli, Haner; Aydin, Sibel Z.; Yazici, Hasan

2015-01-01

Behçet syndrome (BS) is a multisystem vasculitis that is most active during young adulthood, causing serious disability and significant impairment in quality of life. Differences in the disease course, severity, and organ involvement between patients, depending on the age at presentation and sex, makes it impossible to determine a single management strategy. The diversity and variability in the outcome measures used in clinical trials in BS makes it difficult to compare the results or inform physicians about the best management strategy for individual patients. There is a large unmet need to determine or develop validated outcome measures for use in clinical trials in BS that are acceptable to researchers and regulatory agencies. We conducted a systematic review to describe the outcomes and outcome measures that have been used in clinical trials in BS. This review revealed the diversity and variability in the outcomes and outcome measures and the lack of standard definitions for most outcomes and rarity of validated outcome tools for disease assessment in BS. This systematic literature review will identify domains and candidate instruments for use in a Delphi exercise, the next step in the development of a core set of outcome measures that are properly validated and widely accepted by the collaboration of researchers from many different regions of the world and from different specialties, including rheumatology, ophthalmology, dermatology, gastroenterology, and neurology. PMID:24488418

Outcome measures used in clinical trials for Behçet syndrome: a systematic review.

PubMed

Hatemi, Gulen; Merkel, Peter A; Hamuryudan, Vedat; Boers, Maarten; Direskeneli, Haner; Aydin, Sibel Z; Yazici, Hasan

2014-03-01

Behçet syndrome (BS) is a multisystem vasculitis that is most active during young adulthood, causing serious disability and significant impairment in quality of life. Differences in the disease course, severity, and organ involvement between patients, depending on the age at presentation and sex, makes it impossible to determine a single management strategy. The diversity and variability in the outcome measures used in clinical trials in BS makes it difficult to compare the results or inform physicians about the best management strategy for individual patients. There is a large unmet need to determine or develop validated outcome measures for use in clinical trials in BS that are acceptable to researchers and regulatory agencies. We conducted a systematic review to describe the outcomes and outcome measures that have been used in clinical trials in BS. This review revealed the diversity and variability in the outcomes and outcome measures and the lack of standard definitions for most outcomes and rarity of validated outcome tools for disease assessment in BS. This systematic literature review will identify domains and candidate instruments for use in a Delphi exercise, the next step in the development of a core set of outcome measures that are properly validated and widely accepted by the collaboration of researchers from many different regions of the world and from different specialties, including rheumatology, ophthalmology, dermatology, gastroenterology, and neurology.

Advancing Resident Assessment in Graduate Medical Education

PubMed Central

Swing, Susan R.; Clyman, Stephen G.; Holmboe, Eric S.; Williams, Reed G.

2009-01-01

Background The Outcome Project requires high-quality assessment approaches to provide reliable and valid judgments of the attainment of competencies deemed important for physician practice. Intervention The Accreditation Council for Graduate Medical Education (ACGME) convened the Advisory Committee on Educational Outcome Assessment in 2007–2008 to identify high-quality assessment methods. The assessments selected by this body would form a core set that could be used by all programs in a specialty to assess resident performance and enable initial steps toward establishing national specialty databases of program performance. The committee identified a small set of methods for provisional use and further evaluation. It also developed frameworks and processes to support the ongoing evaluation of methods and the longer-term enhancement of assessment in graduate medical education. Outcome The committee constructed a set of standards, a methodology for applying the standards, and grading rules for their review of assessment method quality. It developed a simple report card for displaying grades on each standard and an overall grade for each method reviewed. It also described an assessment system of factors that influence assessment quality. The committee proposed a coordinated, national-level infrastructure to support enhancements to assessment, including method development and assessor training. It recommended the establishment of a new assessment review group to continue its work of evaluating assessment methods. The committee delivered a report summarizing its activities and 5 related recommendations for implementation to the ACGME Board in September 2008. PMID:21975993

The CORE study protocol: a stepped wedge cluster randomised controlled trial to test a co-design technique to optimise psychosocial recovery outcomes for people affected by mental illness in the community mental health setting.

PubMed

Palmer, Victoria J; Chondros, Patty; Piper, Donella; Callander, Rosemary; Weavell, Wayne; Godbee, Kali; Potiriadis, Maria; Richard, Lauralie; Densely, Konstancja; Herrman, Helen; Furler, John; Pierce, David; Schuster, Tibor; Iedema, Rick; Gunn, Jane

2015-03-24

User engagement in mental health service design is heralded as integral to health systems quality and performance, but does engagement improve health outcomes? This article describes the CORE study protocol, a novel stepped wedge cluster randomised controlled trial (SWCRCT) to improve psychosocial recovery outcomes for people with severe mental illness. An SWCRCT with a nested process evaluation will be conducted over nearly 4 years in Victoria, Australia. 11 teams from four mental health service providers will be randomly allocated to one of three dates 9 months apart to start the intervention. The intervention, a modified version of Mental Health Experience Co-Design (MH ECO), will be delivered to 30 service users, 30 carers and 10 staff in each cluster. Outcome data will be collected at baseline (6 months) and at completion of each intervention wave. The primary outcome is improvement in recovery score using the 24-item Revised Recovery Assessment Scale for service users. Secondary outcomes are improvements to user and carer mental health and well-being using the shortened 8-item version of the WHOQOL Quality of Life scale (EUROHIS), changes to staff attitudes using the 19-item Staff Attitudes to Recovery Scale and recovery orientation of services using the 36-item Recovery Self Assessment Scale (provider version). Intervention and usual care periods will be compared using a linear mixed effects model for continuous outcomes and a generalised linear mixed effects model for binary outcomes. Participants will be analysed in the group that the cluster was assigned to at each time point. The University of Melbourne, Human Research Ethics Committee (1340299.3) and the Federal and State Departments of Health Committees (Project 20/2014) granted ethics approval. Baseline data results will be reported in 2015 and outcomes data in 2017. Australian and New Zealand Clinical Trials Registry ACTRN12614000457640. 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 CORE study protocol: a stepped wedge cluster randomised controlled trial to test a co-design technique to optimise psychosocial recovery outcomes for people affected by mental illness in the community mental health setting

PubMed Central

Palmer, Victoria J; Chondros, Patty; Piper, Donella; Callander, Rosemary; Weavell, Wayne; Godbee, Kali; Potiriadis, Maria; Richard, Lauralie; Densely, Konstancja; Herrman, Helen; Furler, John; Pierce, David; Schuster, Tibor; Iedema, Rick; Gunn, Jane

2015-01-01

Introduction User engagement in mental health service design is heralded as integral to health systems quality and performance, but does engagement improve health outcomes? This article describes the CORE study protocol, a novel stepped wedge cluster randomised controlled trial (SWCRCT) to improve psychosocial recovery outcomes for people with severe mental illness. Methods An SWCRCT with a nested process evaluation will be conducted over nearly 4 years in Victoria, Australia. 11 teams from four mental health service providers will be randomly allocated to one of three dates 9 months apart to start the intervention. The intervention, a modified version of Mental Health Experience Co-Design (MH ECO), will be delivered to 30 service users, 30 carers and 10 staff in each cluster. Outcome data will be collected at baseline (6 months) and at completion of each intervention wave. The primary outcome is improvement in recovery score using the 24-item Revised Recovery Assessment Scale for service users. Secondary outcomes are improvements to user and carer mental health and well-being using the shortened 8-item version of the WHOQOL Quality of Life scale (EUROHIS), changes to staff attitudes using the 19-item Staff Attitudes to Recovery Scale and recovery orientation of services using the 36-item Recovery Self Assessment Scale (provider version). Intervention and usual care periods will be compared using a linear mixed effects model for continuous outcomes and a generalised linear mixed effects model for binary outcomes. Participants will be analysed in the group that the cluster was assigned to at each time point. Ethics and dissemination The University of Melbourne, Human Research Ethics Committee (1340299.3) and the Federal and State Departments of Health Committees (Project 20/2014) granted ethics approval. Baseline data results will be reported in 2015 and outcomes data in 2017. Trial registration number Australian and New Zealand Clinical Trials Registry ACTRN12614000457640. PMID:25805530

Accumulating Data to Optimally Predict Obesity Treatment (ADOPT) Core Measures: Environmental Domain.

PubMed

Saelens, Brian E; Arteaga, S Sonia; Berrigan, David; Ballard, Rachel M; Gorin, Amy A; Powell-Wiley, Tiffany M; Pratt, Charlotte; Reedy, Jill; Zenk, Shannon N

2018-04-01

There is growing interest in how environment is related to adults' weight and activity and eating behaviors. However, little is known about whether environmental factors are related to the individual variability seen in adults' intentional weight loss or maintenance outcomes. The environmental domain subgroup of the Accumulating Data to Optimally Predict obesity Treatment (ADOPT) Core Measures Project sought to identify a parsimonious set of objective and perceived neighborhood and social environment constructs and corresponding measures to include in the assessment of response to adult weight-loss treatment. Starting with the home address, the environmental domain subgroup recommended for inclusion in future weight-loss or maintenance studies constructs and measures related to walkability, perceived land use mix, food outlet accessibility (perceived and objective), perceived food availability, socioeconomics, and crime-related safety (perceived and objective) to characterize the home neighborhood environment. The subgroup also recommended constructs and measures related to social norms (perceived and objective) and perceived support to characterize an individual's social environment. The 12 neighborhood and social environment constructs and corresponding measures provide a succinct and comprehensive set to allow for more systematic examination of the impact of environment on adults' weight loss and maintenance. © 2018 The Obesity Society.

Assessment of functional outcomes in patients with head and neck cancer according to the International Classification of Functioning, Disability and Health Core Sets from the perspective of the multi-professional team: results of 4 Delphi surveys.

PubMed

Kirschneck, Michaela; Sabariego, Carla; Singer, Susanne; Tschiesner, Uta

2014-07-01

The International Classification of Functioning, Disability and Health Core Set for Head and Neck Cancer (ICF-HNC) covers the typical spectrum of problems in functioning in head and neck cancer. This study is part of a multistep process to develop practical guidelines in Germany. The purpose of this study was to identify instruments for the assessment of functioning using the ICF-HNC as reference. Four Delphi surveys with physicians, physiotherapists, psychologists, and social workers were performed to identify which aspects of the ICF-HNC are being treated and which assessment tools are recommended for the assessment of functioning. Ninety-seven percent categories of the ICF-HNC were treated by healthcare professionals participating in the current study. Altogether, 33 assessment tools were recommended for therapy monitoring, food intake, pain, further organic problems/laboratory tests, and psychosocial areas. Although the ICF-HNC is being currently implemented by the head and neck cancer experts, several areas are not covered regularly. Additionally, validated tools were rarely recommended. Copyright © 2013 Wiley Periodicals, Inc.

World Hip Trauma Evaluation (WHiTE): framework for embedded comprehensive cohort studies.

PubMed

Costa, Matthew L; Griffin, Xavier L; Achten, Juul; Metcalfe, David; Judge, Andrew; Pinedo-Villanueva, Rafael; Parsons, Nicholas

2016-10-21

Osteoporotic hip fractures present a significant global challenge to patients, clinicians and healthcare systems. It is estimated that hip fracture accounts for 1.4% of total social and healthcare costs in the established market economies. The World Hip Trauma Evaluation (WHiTE) was set up to measure outcome in a comprehensive cohort of UK patients with hip fracture. All patients in the cohort are treated under a single comprehensive treatment pathway. A core outcome set, including health-related quality of life, is collected on all the patients. This protocol describes the current multicentre project that will be used as a vehicle to deliver a series of embedded observational studies. Research Ethics Committee approval was granted (Rec reference 11/LO/0927, approved 18/8/2011) and each hospital trust provided National Health Service (NHS) approvals. The study is registered with National Institute of Health Research Portfolio (UKCRN ID 12351) and the ISRCTN registry (ISRCTN63982700). 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/.

Multiple genome alignment for identifying the core structure among moderately related microbial genomes.

PubMed

Uchiyama, Ikuo

2008-10-31

Identifying the set of intrinsically conserved genes, or the genomic core, among related genomes is crucial for understanding prokaryotic genomes where horizontal gene transfers are common. Although core genome identification appears to be obvious among very closely related genomes, it becomes more difficult when more distantly related genomes are compared. Here, we consider the core structure as a set of sufficiently long segments in which gene orders are conserved so that they are likely to have been inherited mainly through vertical transfer, and developed a method for identifying the core structure by finding the order of pre-identified orthologous groups (OGs) that maximally retains the conserved gene orders. The method was applied to genome comparisons of two well-characterized families, Bacillaceae and Enterobacteriaceae, and identified their core structures comprising 1438 and 2125 OGs, respectively. The core sets contained most of the essential genes and their related genes, which were primarily included in the intersection of the two core sets comprising around 700 OGs. The definition of the genomic core based on gene order conservation was demonstrated to be more robust than the simpler approach based only on gene conservation. We also investigated the core structures in terms of G+C content homogeneity and phylogenetic congruence, and found that the core genes primarily exhibited the expected characteristic, i.e., being indigenous and sharing the same history, more than the non-core genes. The results demonstrate that our strategy of genome alignment based on gene order conservation can provide an effective approach to identify the genomic core among moderately related microbial genomes.

Long-Term Efficacy of Psychosocial Treatments for Adults With Attention-Deficit/Hyperactivity Disorder: A Meta-Analytic Review

PubMed Central

López-Pinar, Carlos; Martínez-Sanchís, Sonia; Carbonell-Vayá, Enrique; Fenollar-Cortés, Javier; Sánchez-Meca, Julio

2018-01-01

Background: Recent evidence suggests that psychosocial treatments, particularly cognitive-behavioral therapy (CBT), are effective interventions for adult attention deficit hyperactivity disorder (ADHD). The objective of this review was to determine the long-term efficacy of psychosocial interventions in improving clinically relevant variables, including ADHD core symptoms, clinical global impression (CGI), and global functioning. Methods: In total, nine randomized controlled trials and three uncontrolled single-group pretest-posttest studies were included. The data from these studies were combined using the inverse variance method. Heterogeneity and risk of bias were assessed. Subgroup analyses and meta-regressions were performed, to determine the influence of different potential moderator variables (risk of bias, medication status, follow-up length, therapy type and setting, and control group type) on effect size (ES) estimates. Results: Up to 680 of a total of 1,073 participants assessed pre-treatment were retained at follow-up. Treatment groups showed greater improvement than control groups in self-reported total ADHD symptoms, inattention, and hyperactivity/impulsivity, in addition to CGI and global functioning. Blind assessors also reported a large ES in within-subject outcomes. Studies using dialectical behavioral therapy (DBT) in a group setting, with active control matching, and that were rated as having an unclear risk of bias, achieved significantly lower ES estimates for most outcomes. Treatment effectiveness, according to the CGI measure, and global functioning were significantly increased when the percentage of medicated participants was greater. Conclusions: Our results indicate that the post-treatment gains reported in previous reviews are sustained for at least 12 months. Nevertheless, these results must be interpreted with caution, because of a high level of heterogeneity among studies and the risk of bias observed in the majority of outcomes. Thus, these findings indicate that psychological interventions are a highly valuable and stable clinical tool for the treatment of core symptoms and global functioning in adults with ADHD. PMID:29780342

Long-Term Efficacy of Psychosocial Treatments for Adults With Attention-Deficit/Hyperactivity Disorder: A Meta-Analytic Review.

PubMed

López-Pinar, Carlos; Martínez-Sanchís, Sonia; Carbonell-Vayá, Enrique; Fenollar-Cortés, Javier; Sánchez-Meca, Julio

2018-01-01

Background: Recent evidence suggests that psychosocial treatments, particularly cognitive-behavioral therapy (CBT), are effective interventions for adult attention deficit hyperactivity disorder (ADHD). The objective of this review was to determine the long-term efficacy of psychosocial interventions in improving clinically relevant variables, including ADHD core symptoms, clinical global impression (CGI), and global functioning. Methods: In total, nine randomized controlled trials and three uncontrolled single-group pretest-posttest studies were included. The data from these studies were combined using the inverse variance method. Heterogeneity and risk of bias were assessed. Subgroup analyses and meta-regressions were performed, to determine the influence of different potential moderator variables (risk of bias, medication status, follow-up length, therapy type and setting, and control group type) on effect size (ES) estimates. Results: Up to 680 of a total of 1,073 participants assessed pre-treatment were retained at follow-up. Treatment groups showed greater improvement than control groups in self-reported total ADHD symptoms, inattention, and hyperactivity/impulsivity, in addition to CGI and global functioning. Blind assessors also reported a large ES in within-subject outcomes. Studies using dialectical behavioral therapy (DBT) in a group setting, with active control matching, and that were rated as having an unclear risk of bias, achieved significantly lower ES estimates for most outcomes. Treatment effectiveness, according to the CGI measure, and global functioning were significantly increased when the percentage of medicated participants was greater. Conclusions: Our results indicate that the post-treatment gains reported in previous reviews are sustained for at least 12 months. Nevertheless, these results must be interpreted with caution, because of a high level of heterogeneity among studies and the risk of bias observed in the majority of outcomes. Thus, these findings indicate that psychological interventions are a highly valuable and stable clinical tool for the treatment of core symptoms and global functioning in adults with ADHD.

Exploring the comparative responsiveness of a core set of outcome measures in a school-based conductive education programme.

PubMed

Wright, F V; Boschen, K; Jutai, J

2005-05-01

Conductive education (CE) is a holistic educational system that uses an active cognitive approach to teach individuals with motor disorders to become more functional participants in daily activities. While CE's popularity continues to grow in North America and Europe, its effectiveness has not been established. The lack of definition of responsive outcome measures for evaluation of CE programmes has limited the interpretability of conclusions from earlier studies evaluating effectiveness. To determine which measures from a core set were most responsive to physical, functional and psychosocial changes associated with a school-based CE programme. This was a one-group before and after data collection design using an 8-month follow-up period. We enrolled a referral sample of nine children with cerebral palsy in Kindergarten or Grade 1 (Gross Motor Function Classification System levels 3, 4 or 5). The study took place within a school-based CE programme at a Canadian children's rehabilitation centre. Children participated in a CE full-day class for an entire school year. Physical, functional, psychosocial and participation measures included: Gross Motor Function Measure (GMFM), Quality of Upper Extremity Skills Test (QUEST), Peabody Developmental Motor Scales, Paediatric Evaluation of Disability Inventory (PEDI), Pictorial Scale of Perceived Competence and Social Acceptance for Young Children, Individualized Educational Plan, and Goal Attainment Scaling (GAS). Four children from the study's second year were also evaluated on the Impact on Family Scale (IFS), GAS and School Function Assessment. The Gross Motor Function Measure, QUEST, PEDI (Caregiver Assistance) and IFS were most responsive to change. GAS was useful in documenting and quantifying goals. Problems were encountered in evaluating self-esteem and school participation. Several strong measures of outcome were identified. Further work is needed to find valid and sensitive psychosocial and school participation measures for these young children.

Control of autonomous robot using neural networks

NASA Astrophysics Data System (ADS)

Barton, Adam; Volna, Eva

2017-07-01

The aim of the article is to design a method of control of an autonomous robot using artificial neural networks. The introductory part describes control issues from the perspective of autonomous robot navigation and the current mobile robots controlled by neural networks. The core of the article is the design of the controlling neural network, and generation and filtration of the training set using ART1 (Adaptive Resonance Theory). The outcome of the practical part is an assembled Lego Mindstorms EV3 robot solving the problem of avoiding obstacles in space. To verify models of an autonomous robot behavior, a set of experiments was created as well as evaluation criteria. The speed of each motor was adjusted by the controlling neural network with respect to the situation in which the robot was found.

OMERACT Endorsement of Patient-reported Outcome Instruments in Antineutrophil Cytoplasmic Antibody–associated Vasculitis

PubMed Central

Robson, Joanna C.; Tomasson, Gunnar; Milman, Nataliya; Ashdown, Sue; Boonen, Annelies; Casey, George C.; Cronholm, Peter F.; Cuthbertson, David; Dawson, Jill; Direskeneli, Haner; Easley, Ebony; Kermani, Tanaz A.; Farrar, John T.; Gebhart, Don; Lanier, Georgia; Luqmani, Raashid A.; Mahr, Alfred; McAlear, Carol A.; Peck, Jacqueline; Shea, Beverley; Shea, Judy A.; Sreih, Antoine G.; Tugwell, Peter S.; Merkel, Peter A.

2018-01-01

Objective The antineutrophil cytoplasmic antibody–associated vasculitides (AAV) are multiorgan diseases. Patients with AAV report impairment in their health-related quality of life (HRQOL) and have different priorities regarding disease assessment compared with physicians. The Outcome Measures in Rheumatology (OMERACT) Vasculitis Working Group previously received endorsement for a core set of domains in AAV. Two approaches to measure patient-reported outcomes (PRO) were presented at OMERACT 2016. Methods A novel 5-step tool was used to facilitate assessment of the instruments by delegates: the OMERACT Filter 2.0 Instrument Selection Algorithm, with a red-amber-green checklist of questions, including (1) good match with domain (face and content validity), (2) feasibility, (3) do numeric scores make sense (construct validity)?, (4) overall ratings of discrimination, and (5) can individual thresholds of meaning be defined? Delegates gave an overall endorsement. Three generic Patient-Reported Outcomes Measurement Information System (PROMIS) instruments (fatigue, physical functioning, and pain interference) and a disease-specific PRO, the AAV-PRO (6 domains related to symptoms and HRQOL), were presented. Results OMERACT delegates endorsed the use of the PROMIS instruments for fatigue, physical functioning, and pain interference (87.6% overall endorsement) and the disease-specific AAV-PRO instrument (89.4% overall endorsement). Conclusion The OMERACT Vasculitis Working Group gained endorsement by OMERACT for use of the PROMIS and the AAV-PRO in clinical trials of vasculitis. These instruments are complementary to each other. The PROMIS and the AAV-PRO need further work to assess their utility in longitudinal settings, including their ability to discriminate between treatments of varying efficacy in the setting of a randomized controlled trial. PMID:28864650

Strategies to use tablet computers for collection of electronic patient-reported outcomes.

PubMed

Schick-Makaroff, Kara; Molzahn, Anita

2015-01-22

Mobile devices are increasingly being used for data collection in research. However, many researchers do not have experience in collecting data electronically. Hence, the purpose of this short report was to identify issues that emerged in a study that incorporated electronic capture of patient-reported outcomes in clinical settings, and strategies used to address the issues. The issues pertaining to electronic patient-reported outcome data collection were captured qualitatively during a study on use of electronic patient-reported outcomes in two home dialysis units. Fifty-six patients completed three surveys on tablet computers, including the Kidney Disease Quality of Life-36, the Edmonton Symptom Assessment Scale, and a satisfaction measure. Issues that arose throughout the research process were recorded during ethics reviews, implementation process, and data collection. Four core issues emerged including logistics of technology, security, institutional and financial support, and electronic design. Although use of mobile devices for data collection has many benefits, it also poses new challenges for researchers. Advance consideration of possible issues that emerge in the process, and strategies that can help address these issues, may prevent disruption and enhance validity of findings.

Gleason 6 prostate cancer in one or two biopsy cores can harbor more aggressive disease.

PubMed

Katz, Mark H; Shikanov, Sergey; Sun, Maxine; Abdollah, Firas; Budaeus, Lars; Gong, Edward M; Eggener, Scott E; Steinberg, Gary D; Zagaja, Gregory P; Shalhav, Arieh L; Karakiewicz, Pierre I; Zorn, Kevin C

2011-04-01

Patients with Gleason (GL) 6 prostate cancer in one or two biopsy cores can be upgraded and/or upstaged at the time of surgery, which may adversely impact long-term outcome. A novel model for prediction of adverse pathologic outcomes was developed using preoperative characteristics. Between 2003 and 2007, 1159 patients underwent robot-assisted radical prostatectomy (RARP) at our institution. GL 6 prostate cancer in one or two biopsy cores was identified in 416 (36%) patients. Logistic regression analyses were used to assess the rate of GL ≥7 and/or extraprostatic extension at RARP. Covariates consisted of age, body mass index (BMI), number of positive cores, greatest percent of cancer in a core (GPC), clinical stage, and preoperative prostate-specific antigen (PSA) level. After backward variable selection, the developed model was internally validated using the area under the curve and subjected to methods of calibration. Respectively, 278 (67%) and 138 (33%) patients had one or two positive biopsy cores. At RARP, 90 (22%) patients were upgraded to GL ≥7 and 37 (9%) had extraprostatic extension. The novel model relied on age, BMI, preoperative PSA level, and GPC for prediction of adverse pathologic outcomes and was 69% accurate. Calibration plot revealed a virtually perfect relationship between predicted and observed probabilities. In patients with GL 6 prostate cancer in one or two biopsy cores, 25% have more ominous pathology at RARP. The model provides an individual assessment of adverse outcomes at surgery. Consequently, it may be considered when counseling patients regarding their management options.

Validation of the Comprehensive ICF Core Set for Vocational Rehabilitation From the Perspective of Physical Therapists: International Delphi Survey.

PubMed

Kaech Moll, Veronika M; Escorpizo, Reuben; Portmann Bergamaschi, Ruth; Finger, Monika E

2016-08-01

The Comprehensive ICF Core Set for vocational rehabilitation (VR) is a list of essential categories on functioning based on the World Health Organization (WHO) International Classification of Functioning, Disability and Health (ICF), which describes a standard for interdisciplinary assessment, documentation, and communication in VR. The aim of this study was to examine the content validity of the Comprehensive ICF Core Set for VR from the perspective of physical therapists. A 3-round email survey was performed using the Delphi method. A convenience sample of international physical therapists working in VR with work experience of ≥2 years were asked to identify aspects they consider as relevant when evaluating or treating clients in VR. Responses were linked to the ICF categories and compared with the Comprehensive ICF Core Set for VR. Sixty-two physical therapists from all 6 WHO world regions responded with 3,917 statements that were subsequently linked to 338 ICF categories. Fifteen (17%) of the 90 categories in the Comprehensive ICF Core Set for VR were confirmed by the physical therapists in the sample. Twenty-two additional ICF categories were identified that were not included in the Comprehensive ICF Core Set for VR. Vocational rehabilitation in physical therapy is not well defined in every country and might have resulted in the small sample size. Therefore, the results cannot be generalized to all physical therapists practicing in VR. The content validity of the ICF Core Set for VR is insufficient from solely a physical therapist perspective. The results of this study could be used to define a physical therapy-specific set of ICF categories to develop and guide physical therapist clinical practice in VR. © 2016 American Physical Therapy Association.

Content validity of the Comprehensive ICF Core Set for multiple sclerosis from the perspective of speech and language therapists.

PubMed

Renom, Marta; Conrad, Andrea; Bascuñana, Helena; Cieza, Alarcos; Galán, Ingrid; Kesselring, Jürg; Coenen, Michaela

2014-11-01

The Comprehensive International Classification of Functioning, Disability and Health (ICF) Core Set for Multiple Sclerosis (MS) is a comprehensive framework to structure the information obtained in multidisciplinary clinical settings according to the biopsychosocial perspective of the International Classification of Functioning, Disability and Health (ICF) and to guide the treatment and rehabilitation process accordingly. It is now undergoing validation from the user perspective for which it has been developed in the first place. To validate the content of the Comprehensive ICF Core Set for MS from the perspective of speech and language therapists (SLTs) involved in the treatment of persons with MS (PwMS). Within a three-round e-mail-based Delphi Study 34 SLTs were asked about PwMS' problems, resources and aspects of the environment treated by SLTs. Responses were linked to ICF categories. Identified ICF categories were compared with those included in the Comprehensive ICF Core Set for MS to examine its content validity. Thirty-four SLTs named 524 problems and resources, as well as aspects of environment. Statements were linked to 129 ICF categories (60 Body-functions categories, two Body-structures categories, 42 Activities-&-participation categories, and 25 Environmental-factors categories). SLTs confirmed 46 categories in the Comprehensive ICF Core Set. Twenty-one ICF categories were identified as not-yet-included categories. This study contributes to the content validity of the Comprehensive ICF Core Set for MS from the perspective of SLTs. Study participants agreed on a few not-yet-included categories that should be further discussed for inclusion in a revised version of the Comprehensive ICF Core Set to strengthen SLTs' perspective in PwMS' neurorehabilitation. © 2014 Royal College of Speech and Language Therapists.

Two steps forward, one step back? A commentary on the disease-specific core sets of the International Classification of Functioning, Disability and Health (ICF).

PubMed

McIntyre, Anne; Tempest, Stephanie

2007-09-30

The International Classification of Functioning, Disability and Health (ICF) has been received favourably by health care professionals, disability rights organizations and proponents of the social model of disability. The success of the ICF largely depends on its uptake in practice and is considered unwieldy in its full format. To enhance the application of the ICF in practice, disease and site-specific core sets have been developed. The objective of this paper is to stimulate thought and discussion about the place of the ICF core sets in rehabilitation practice. The authors' review of the literature uses the ICF core sets (especially stroke), to debate if the ICF is at risk of taking two steps forward, one step back in its holistic portrayal of health. ICF disease specific core sets could be seen as taking two steps forward to enhance the user friendliness of the ICF and evidence-based practice in rehabilitation. However, there is a danger of taking one step back in reverting to a disease-specific classification. It is too early to conclude the efficacy of the disease-specific core sets, but there is an opportunity to debate where the next steps may lead.

Correlation consistent valence basis sets for use with the Stuttgart-Dresden-Bonn relativistic effective core potentials: The atoms Ga-Kr and In-Xe

NASA Astrophysics Data System (ADS)

Martin, Jan M. L.; Sundermann, Andreas

2001-02-01

We propose large-core correlation-consistent (cc) pseudopotential basis sets for the heavy p-block elements Ga-Kr and In-Xe. The basis sets are of cc-pVTZ and cc-pVQZ quality, and have been optimized for use with the large-core (valence-electrons only) Stuttgart-Dresden-Bonn (SDB) relativistic pseudopotentials. Validation calculations on a variety of third-row and fourth-row diatomics suggest them to be comparable in quality to the all-electron cc-pVTZ and cc-pVQZ basis sets for lighter elements. Especially the SDB-cc-pVQZ basis set in conjunction with a core polarization potential (CPP) yields excellent agreement with experiment for compounds of the later heavy p-block elements. For accurate calculations on Ga (and, to a lesser extent, Ge) compounds, explicit treatment of 13 valence electrons appears to be desirable, while it seems inevitable for In compounds. For Ga and Ge, we propose correlation consistent basis sets extended for (3d) correlation. For accurate calculations on organometallic complexes of interest to homogenous catalysis, we recommend a combination of the standard cc-pVTZ basis set for first- and second-row elements, the presently derived SDB-cc-pVTZ basis set for heavier p-block elements, and for transition metals, the small-core [6s5p3d] Stuttgart-Dresden basis set-relativistic effective core potential combination supplemented by (2f1g) functions with exponents given in the Appendix to the present paper.

Conceptual Underpinnings of the Quality of Life in Neurological Disorders (Neuro-QoL): Comparisons of Core Sets for Stroke, Multiple Sclerosis, Spinal Cord Injury, and Traumatic Brain Injury.

PubMed

Wong, Alex W K; Lau, Stephen C L; Fong, Mandy W M; Cella, David; Lai, Jin-Shei; Heinemann, Allen W

2018-04-03

To determine the extent to which the content of the Quality of Life in Neurological Disorders (Neuro-QoL) covers the International Classification of Functioning, Disability and Health (ICF) Core Sets for multiple sclerosis (MS), stroke, spinal cord injury (SCI), and traumatic brain injury (TBI) using summary linkage indicators. Content analysis by linking content of the Neuro-QoL to corresponding ICF codes of each Core Set for MS, stroke, SCI, and TBI. Three academic centers. None. None. Four summary linkage indicators proposed by MacDermid et al were estimated to compare the content coverage between Neuro-QoL and the ICF codes of Core Sets for MS, stroke, MS, and TBI. Neuro-QoL represented 20% to 30% Core Set codes for different conditions in which more codes in Core Sets for MS (29%), stroke (28%), and TBI (28%) were covered than those for SCI in the long-term (20%) and early postacute (19%) contexts. Neuro-QoL represented nearly half of the unique Activity and Participation codes (43%-49%) and less than one third of the unique Body Function codes (12%-32%). It represented fewer Environmental Factors codes (2%-6%) and no Body Structures codes. Absolute linkage indicators found that at least 60% of Neuro-QoL items were linked to Core Set codes (63%-95%), but many items covered the same codes as revealed by unique linkage indicators (7%-13%), suggesting high concept redundancy among items. The Neuro-QoL links more closely to ICF Core Sets for stroke, MS, and TBI than to those for SCI, and primarily covers activity and participation ICF domains. Other instruments are needed to address concepts not measured by the Neuro-QoL when a comprehensive health assessment is needed. Copyright © 2018 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Low back pain in 17 countries, a Rasch analysis of the ICF core set for low back pain.

PubMed

Røe, Cecilie; Bautz-Holter, Erik; Cieza, Alarcos

2013-03-01

Previous studies indicate that a worldwide measurement tool may be developed based on the International Classification of Functioning Disability and Health (ICF) Core Sets for chronic conditions. The aim of the present study was to explore the possibility of constructing a cross-cultural measurement of functioning for patients with low back pain (LBP) on the basis of the Comprehensive ICF Core Set for LBP and to evaluate the properties of the ICF Core Set. The Comprehensive ICF Core Set for LBP was scored by health professionals for 972 patients with LBP from 17 countries. Qualifier levels of the categories, invariance across age, sex and countries, construct validity and the ordering of the categories in the components of body function, body structure, activities and participation were explored by Rasch analysis. The item-trait χ2-statistics showed that the 53 categories in the ICF Core Set for LBP did not fit the Rasch model (P<0.001). The main challenge was the invariance in the responses according to country. Analysis of the four countries with the largest sample sizes indicated that the data from Germany fit the Rasch model, and the data from Norway, Serbia and Kuwait in terms of the components of body functions and activities and participation also fit the model. The component of body functions and activity and participation had a negative mean location, -2.19 (SD 1.19) and -2.98 (SD 1.07), respectively. The negative location indicates that the ICF Core Set reflects patients with a lower level of function than the present patient sample. The present results indicate that it may be possible to construct a clinical measure of function on the basis of the Comprehensive ICF Core Set for LBP by calculating country-specific scores before pooling the data.

COMSKIL Communication Training in Oncology-Adaptation to German Cancer Care Settings.

PubMed

Hartung, Tim J; Kissane, David; Mehnert, Anja

2018-01-01

Medical communication is a skill which can be learned and taught and which can substantially improve treatment outcomes, especially if patients' communication preferences are taken into account. Here, we give an overview of communication training research and outline the COMSKIL program as a state-of-the-art communication skills training in oncology. COMSKIL has a solid theoretical foundation and teaches core elements of medical communication in up to ten fully operationalized modules. These address typical situations ranging from breaking bad news to responding to difficult emotions, shared decision-making, and communicating via interpreters.

Approach to numerical safety guidelines based on a core melt criterion. [PWR; BWR

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

Azarm, M.A.; Hall, R.E.

1982-01-01

A plausible approach is proposed for translating a single level criterion to a set of numerical guidelines. The criterion for core melt probability is used to set numerical guidelines for various core melt sequences, systems and component unavailabilities. These guidelines can be used as a means for making decisions regarding the necessity for replacing a component or improving part of a safety system. This approach is applied to estimate a set of numerical guidelines for various sequences of core melts that are analyzed in Reactor Safety Study for the Peach Bottom Nuclear Power Plant.

Effects of a School-Based Social Skills Training Program for Adolescents with Autism Spectrum Disorder and Intellectual Disability.

PubMed

Plavnick, Joshua B; Kaid, Tiffany; MacFarland, Mari C

2015-09-01

Social deficits are a core characteristic of individuals with autism spectrum disorders and co-occurring intellectual disabilities (ASD-ID). Despite persistence of these deficits into adolescence, few social skills interventions have been empirically evaluated for older individuals with ASD-ID. The present investigation adapted an efficacious protocol for adolescents with ASD, video-based group instruction (VGI), and extended the procedure to 4 adolescents in a public high school setting. A multiple probe across behaviors design demonstrated the effectiveness of VGI for teaching novel social behavior to three of the four participants, with mixed outcomes for the fourth participant. Long-term maintenance was observed for two participants, though generalization outcomes were mixed. The results support using VGI within high school curricula for some adolescents with ASD-ID.

End-of-Kindergarten Spelling Outcomes: How Can Spelling Error Analysis Data Inform Beginning Reading Instruction?

PubMed Central

Lee, Julia Ai Cheng; Otaiba, Stephanie Al

2016-01-01

In this article, the authors examined the spelling performance of 430 kindergarteners, which included a high risk sample, to determine the relations between end of kindergarten reading and spelling in a high quality language arts setting. The spelling outcomes including the spelling errors between the good and the poor readers were described, analyzed, and compared. The findings suggest that not all the children have acquired the desired standard as outlined by the Common Core State Standards. In addition, not every good reader is a good speller and that not every poor speller is a poor reader. The study shows that spelling tasks that are accompanied by spelling errors analysis provide a powerful window for making instructional sense of children’s spelling errors and for individualizing spelling instructional strategies. PMID:28706433

Clinicians' and researchers' perspectives on establishing and implementing core outcomes in haemodialysis: semistructured interview study.

PubMed

Tong, Allison; Crowe, Sally; Gill, John S; Harris, Tess; Hemmelgarn, Brenda R; Manns, Braden; Pecoits-Filho, Roberto; Tugwell, Peter; van Biesen, Wim; Wang, Angela Yee Moon; Wheeler, David C; Winkelmayer, Wolfgang C; Gutman, Talia; Ju, Angela; O'Lone, Emma; Sautenet, Benedicte; Viecelli, Andrea; Craig, Jonathan C

2018-04-20

To describe the perspectives of clinicians and researchers on identifying, establishing and implementing core outcomes in haemodialysis and their expected impact. Face-to-face, semistructured interviews; thematic analysis. Twenty-seven centres across nine countries. Fifty-eight nephrologists (42 (72%) who were also triallists). We identified six themes: reflecting direct patient relevance and impact (survival as the primary goal of dialysis, enabling well-being and functioning, severe consequences of comorbidities and complications, indicators of treatment success, universal relevance, stakeholder consensus); amenable and responsive to interventions (realistic and possible to intervene on, differentiating between treatments); reflective of economic burden on healthcare; feasibility of implementation (clarity and consistency in definition, easily measurable, requiring minimal resources, creating a cultural shift, aversion to intensifying bureaucracy, allowing justifiable exceptions); authoritative inducement and directive (endorsement for legitimacy, necessity of buy-in from dialysis providers, incentivising uptake); instituting patient-centredness (explicitly addressing patient-important outcomes, reciprocating trial participation, improving comparability of interventions for decision-making, driving quality improvement and compelling a focus on quality of life). Nephrologists emphasised that core outcomes should be relevant to patients, amenable to change, feasible to implement and supported by stakeholder organisations. They expected core outcomes would improve patient-centred care and outcomes. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Tracking Student Progression through the Core Curriculum. CCRC Analytics

ERIC Educational Resources Information Center

Hodara, Michelle; Rodriguez, Olga

2013-01-01

This report demonstrates useful methods for examining student progression through the core curriculum. The authors carry out analyses at two colleges in two different states, illustrating students' overall progression through the core curriculum and the relationship of this "core" progression to their college outcomes. By means of this analysis,…

Clinical outcomes with daptomycin: a post-marketing, real-world evaluation.

PubMed

Sakoulas, G

2009-12-01

The Cubicin Outcomes Registry and Experience (CORE) is an ongoing, retrospective, post-marketing database of daptomycin use in the USA. Although non-comparative, CORE offers insight into real-life clinical experience with daptomycin in various Gram-positive infections and specific patient types. Analyses of daptomycin treatment outcomes using the CORE database revealed that treatment with daptomycin has resulted in high rates of clinical success for a variety of Gram-positive infections, including indicated infections such as complicated skin and soft tissue infections, Staphylococcus aureus bacteraemia and right-sided infective endocarditis, and non-indicated infections such as osteomyelitis. Treatment outcomes did not differ significantly according to the causative pathogen for any of the analyses performed and were not influenced by the vancomycin MIC. Patients frequently received therapy with alternative antibiotics prior to treatment with daptomycin, particularly those patients with more serious infections. However, similar treatment outcomes were observed when daptomycin was used as first-line therapy or as salvage therapy, demonstrating the effectiveness of daptomycin in the treatment of these patients.

Identifying ELIXIR Core Data Resources

PubMed Central

Durinx, Christine; McEntyre, Jo; Appel, Ron; Apweiler, Rolf; Barlow, Mary; Blomberg, Niklas; Cook, Chuck; Gasteiger, Elisabeth; Kim, Jee-Hyub; Lopez, Rodrigo; Redaschi, Nicole; Stockinger, Heinz; Teixeira, Daniel; Valencia, Alfonso

2017-01-01

The core mission of ELIXIR is to build a stable and sustainable infrastructure for biological information across Europe. At the heart of this are the data resources, tools and services that ELIXIR offers to the life-sciences community, providing stable and sustainable access to biological data. ELIXIR aims to ensure that these resources are available long-term and that the life-cycles of these resources are managed such that they support the scientific needs of the life-sciences, including biological research. ELIXIR Core Data Resources are defined as a set of European data resources that are of fundamental importance to the wider life-science community and the long-term preservation of biological data. They are complete collections of generic value to life-science, are considered an authority in their field with respect to one or more characteristics, and show high levels of scientific quality and service. Thus, ELIXIR Core Data Resources are of wide applicability and usage. This paper describes the structures, governance and processes that support the identification and evaluation of ELIXIR Core Data Resources. It identifies key indicators which reflect the essence of the definition of an ELIXIR Core Data Resource and support the promotion of excellence in resource development and operation. It describes the specific indicators in more detail and explains their application within ELIXIR’s sustainability strategy and science policy actions, and in capacity building, life-cycle management and technical actions. The identification process is currently being implemented and tested for the first time. The findings and outcome will be evaluated by the ELIXIR Scientific Advisory Board in March 2017. Establishing the portfolio of ELIXIR Core Data Resources and ELIXIR Services is a key priority for ELIXIR and publicly marks the transition towards a cohesive infrastructure. PMID:27803796

Identifying ELIXIR Core Data Resources.

PubMed

Durinx, Christine; McEntyre, Jo; Appel, Ron; Apweiler, Rolf; Barlow, Mary; Blomberg, Niklas; Cook, Chuck; Gasteiger, Elisabeth; Kim, Jee-Hyub; Lopez, Rodrigo; Redaschi, Nicole; Stockinger, Heinz; Teixeira, Daniel; Valencia, Alfonso

2016-01-01

The core mission of ELIXIR is to build a stable and sustainable infrastructure for biological information across Europe. At the heart of this are the data resources, tools and services that ELIXIR offers to the life-sciences community, providing stable and sustainable access to biological data. ELIXIR aims to ensure that these resources are available long-term and that the life-cycles of these resources are managed such that they support the scientific needs of the life-sciences, including biological research. ELIXIR Core Data Resources are defined as a set of European data resources that are of fundamental importance to the wider life-science community and the long-term preservation of biological data. They are complete collections of generic value to life-science, are considered an authority in their field with respect to one or more characteristics, and show high levels of scientific quality and service. Thus, ELIXIR Core Data Resources are of wide applicability and usage. This paper describes the structures, governance and processes that support the identification and evaluation of ELIXIR Core Data Resources. It identifies key indicators which reflect the essence of the definition of an ELIXIR Core Data Resource and support the promotion of excellence in resource development and operation. It describes the specific indicators in more detail and explains their application within ELIXIR's sustainability strategy and science policy actions, and in capacity building, life-cycle management and technical actions. The identification process is currently being implemented and tested for the first time. The findings and outcome will be evaluated by the ELIXIR Scientific Advisory Board in March 2017. Establishing the portfolio of ELIXIR Core Data Resources and ELIXIR Services is a key priority for ELIXIR and publicly marks the transition towards a cohesive infrastructure.

Setting an Agenda for Assessment of Health-related Quality of Life Among Men with Prostate Cancer on Active Surveillance: A Consensus Paper from a European School of Oncology Task Force.

PubMed

Villa, Silvia; Kendel, Friederike; Venderbos, Lionne; Rancati, Tiziana; Bangma, Chris; Carroll, Peter; Denis, Louis; Klotz, Laurence; Korfage, Ida J; Lane, Athene J; Magnani, Tiziana; Mastris, Ken; Rannikko, Antti; Roobol, Monique; Trock, Bruce; Van den Bergh, Roderick; Van Poppel, Hendrik; Valdagni, Riccardo; Bellardita, Lara

2017-02-01

Literature on the health-related quality of life (HRQoL) for men with localized prostate cancer (PCa) on active surveillance (AS) shows a need for methodological guidance regarding HRQoL issues and how to address them. The European School of Oncology Task Force (ESO TF) aimed to identify a core set of research questions and related measures to include in AS HRQoL studies. A modified Delphi study was used to reach consensus on AS HRQoL research topics and tools between 2014 and 2015. Data were collected by engaging a multidisciplinary team of 15 experts. An open-ended questionnaire was used to collect information from ESO TF members regarding issues in AS HRQoL research. Then a structured questionnaire was used to collect ratings on the usefulness/importance of different AS HRQoL aspects. Items that ≥80% of ESO TF members rated as useful/important were retained. Items with a 50-80% rating were discussed to reach final agreement. Six main research questions concerning the selection of outcome measures, measurement tools, and comparison groups were identified as relevant. The core set of measures identified were related to individual characteristics, psychological dimensions; decision-making-related issues, and physical functioning. The multidisciplinary expertise of ESO TF members was a significant asset, even if bringing different backgrounds to the discussion table represented a challenge. HRQoL measures have to be sensitive to the specific needs of men on AS. The definition of HRQoL outcomes will enhance a broader understanding of the HRQoL of men on AS and sustain patient-centered medicine. An international panel agreed on a set of health-related quality-of-life aspects to be assessed among men on active surveillance for prostate cancer. Valid relevant questionnaires were identified. The experts' indications lay a foundation for future research and clinical practice. Copyright © 2016 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Reporting outcomes of definitive radiation-based treatment for esophageal cancer: a review of the literature.

PubMed

Main, B G; Strong, S; McNair, A G; Falk, S J; Crosby, T; Blazeby, J M

2015-01-01

Accurate evaluation of radical radiotherapy requires well designed research with valid and appropriate outcomes. This study reviewed standards of outcome reporting and study design in randomized controlled trials (RCTs) of radiation-based therapy for esophageal cancer and made recommendations for future work. Randomized controlled trials reporting outcomes of definitive radiation-based treatment alone or in combination with chemotherapy were systematically identified and summarized. The types, frequency, and definitions of all clinical and patient-reported outcomes (PROs) reported in the methods and results sections of papers were examined. Studies providing a definition for at least one outcome and presenting all outcomes reported in the methods were classified as high quality. From 1425 abstracts, 16 RCTs including 1803 patients were identified. The primary outcome was overall survival in 13 studies, but five different definitions were reported. Outcomes for treatment failure included local, regional, and distant failures, and inconsistent definitions were applied. An observer assessment of dysphagia was reported in seven RCTs but PROs were reported in only one. Only three RCTs were at low risk of bias, with all lacking reports of sequence generation and only a minority reporting allocation concealment. The quality of outcome reporting in RCTs was inconsistent and risked bias. A core outcome set including clinical and PROs is needed to improve reporting of trials of definitive radiation-based treatment for esophageal cancer. © 2014 International Society for Diseases of the Esophagus.

Recent advances in Takayasu’s arteritis

PubMed Central

Alibaz-Öner, Fatma; Aydın, Sibel Zehra; Direskeneli, Haner

2015-01-01

Takayasu’s arteritis (TAK) is a rare, chronic large-vessel vasculitis (LVV) that predominantly affects the aorta, its major branches, and the pulmonary arteries. Recent advances in the diagnosis, clinical course, disease assessment with biomarkers/imaging and new clinical tools, patient-reported outcomes, and new treatment options of TAK are discussed in this review. Conventional angiography, the gold standard method for initial diagnosis, appears to have been replaced with new imaging modalities such as magnetic resonance angiography (MRA) and 18F-fluorodeoxyglucose positron emission tomography (FDG-PET) in recent years. MRA and FDG-PET are also promising for the assessment of disease activity. New tools for disease assessment such as Indian Takayasu’s Arteritis Score 2010 (ITAS2010) and color Doppler ultrasound (CDUS) aim to better characterize and quantify disease activity; however, different imaging modalities in routine follow-up are not incorporated sufficiently in these approaches. Prognosis is possibly getting better, with lower mortality in recent years; however, it is difficult to assess the widely different vascular intervention rates among the clinical series. Leflunomide, tumor necrosis factor (TNF)-α antagonists, and tocilizumab are new options for patients resistant to conventional therapies. There is a clear need to develop a validated set of outcome measures for use in clinical trials of TAK. The Outcome Measures in Rheumatology (OMERACT) Vasculitis Working Group has taken on this task, finished a Delphi exercise with experts, and aims to develop a core set of outcomes for LVV in accordance with OMERACT Filter 2.0. PMID:27708916

Competency-based education: the essential basis of pre-service education for the professional midwifery workforce.

PubMed

Fullerton, Judith T; Thompson, Joyce B; Johnson, Peter

2013-10-01

many articles published in the decade since promulgation of the Millennium Development Goals have acknowledged the distinct advantages to maternal and newborn health outcomes that can be achieved as a result of expanding access to skilled birth attendant (including midwifery) services. However, these advantages are often predicated on the assumption that the midwifery workforce shares a common definition and identity. Regrettably, a clear delineation of midwifery competencies is rarely addressed. A core set of midwifery competencies is essential to providing the high quality services that lead to the desirable health outcomes described in that body of research. Attribution of improved outcomes to access to midwifery cannot be made without a common understanding of a defined set of services provided to standard by the midwifery workforce across the inter-conceptional and childbearing time frame. The International Confederation of Midwives (ICM) has developed a clear list of competencies that delineate the domains of practice for the fully qualified, professional midwife. These domains frame the educational outcomes that must be conveyed within competency-based education programmes. this article explores the concept of competency-based education for midwives; first exploring the concept of competency itself, then providing examples of what is already known about competency-based approaches to curriculum design, teacher preparation, teacher support and assessment of student learning. These concepts are linked to the ICM competencies as the unifying construct for education of individuals who share a common definition and identity as midwives. © 2013 Elsevier Ltd. All rights reserved.

Applications of nutrient profiling: potential role in diet-related chronic disease prevention and the feasibility of a core nutrient-profiling system.

PubMed

Sacks, G; Rayner, M; Stockley, L; Scarborough, P; Snowdon, W; Swinburn, B

2011-03-01

A number of different nutrient-profiling models have been proposed and several applications of nutrient profiling have been identified. This paper outlines the potential role of nutrient-profiling applications in the prevention of diet-related chronic disease (DRCD), and considers the feasibility of a core nutrient-profiling system, which could be modified for purpose, to underpin the multiple potential applications in a particular country. The 'Four 'P's of Marketing' (Product, Promotion, Place and Price) are used as a framework for identifying and for classifying potential applications of nutrient profiling. A logic pathway is then presented that can be used to gauge the potential impact of nutrient-profiling interventions on changes in behaviour, changes in diet and, ultimately, changes in DRCD outcomes. The feasibility of a core nutrient-profiling system is assessed by examining the implications of different model design decisions and their suitability to different purposes. There is substantial scope to use nutrient profiling as part of the policies for the prevention of DRCD. A core nutrient-profiling system underpinning the various applications is likely to reduce discrepancies and minimise the confusion for regulators, manufacturers and consumers. It seems feasible that common elements, such as a standard scoring method, a core set of nutrients and food components, and defined food categories, could be incorporated as part of a core system, with additional application-specific criteria applying. However, in developing and in implementing such a system, several country-specific contextual and technical factors would need to be balanced.

Measures of digit span and verbal rehearsal speed in deaf children after more than 10 years of cochlear implantation.

PubMed

Pisoni, David B; Kronenberger, William G; Roman, Adrienne S; Geers, Ann E

2011-02-01

Conventional assessments of outcomes in deaf children with cochlear implants (CIs) have focused primarily on endpoint or product measures of speech and language. Little attention has been devoted to understanding the basic underlying core neurocognitive factors involved in the development and processing of speech and language. In this study, we examined the development of factors related to the quality of phonological information in immediate verbal memory, including immediate memory capacity and verbal rehearsal speed, in a sample of deaf children after >10 yrs of CI use and assessed the correlations between these two process measures and a set of speech and language outcomes. Of an initial sample of 180 prelingually deaf children with CIs assessed at ages 8 to 9 yrs after 3 to 7 yrs of CI use, 112 returned for testing again in adolescence after 10 more years of CI experience. In addition to completing a battery of conventional speech and language outcome measures, subjects were administered the Wechsler Intelligence Scale for Children-III Digit Span subtest to measure immediate verbal memory capacity. Sentence durations obtained from the McGarr speech intelligibility test were used as a measure of verbal rehearsal speed. Relative to norms for normal-hearing children, Digit Span scores were well below average for children with CIs at both elementary and high school ages. Improvement was observed over the 8-yr period in the mean longest digit span forward score but not in the mean longest digit span backward score. Longest digit span forward scores at ages 8 to 9 yrs were significantly correlated with all speech and language outcomes in adolescence, but backward digit spans correlated significantly only with measures of higher-order language functioning over that time period. While verbal rehearsal speed increased for almost all subjects between elementary grades and high school, it was still slower than the rehearsal speed obtained from a control group of normal-hearing adolescents. Verbal rehearsal speed at ages 8 to 9 yrs was also found to be strongly correlated with speech and language outcomes and Digit Span scores in adolescence. Despite improvement after 8 additional years of CI use, measures of immediate verbal memory capacity and verbal rehearsal speed, which reflect core fundamental information processing skills associated with representational efficiency and information processing capacity, continue to be delayed in children with CIs relative to NH peers. Furthermore, immediate verbal memory capacity and verbal rehearsal speed at 8 to 9 yrs of age were both found to predict speech and language outcomes in adolescence, demonstrating the important contribution of these processing measures for speech-language development in children with CIs. Understanding the relations between these core underlying processes and speech-language outcomes in children with CIs may help researchers to develop new approaches to intervention and treatment of deaf children who perform poorly with their CIs. Moreover, this knowledge could be used for early identification of deaf children who may be at high risk for poor speech and language outcomes after cochlear implantation as well as for the development of novel targeted interventions that focus selectively on these core elementary information processing variables.

Anatomical Society core regional anatomy syllabus for undergraduate medicine: the Delphi process.

PubMed

Smith, C F; Finn, G M; Stewart, J; McHanwell, S

2016-01-01

A modified Delphi method was employed to seek consensus when revising the UK and Ireland's core syllabus for regional anatomy in undergraduate medicine. A Delphi panel was constructed involving 'expert' (individuals with at least 5 years' experience in teaching medical students anatomy at the level required for graduation). The panel (n = 39) was selected and nominated by members of Council and/or the Education Committee of the Anatomical Society and included a range of specialists including surgeons, radiologists and anatomists. The experts were asked in two stages to 'accept', 'reject' or 'modify' (first stage only) each learning outcome. A third stage, which was not part of the Delphi method, then allowed the original authors of the syllabus to make changes either to correct any anatomical errors or to make minor syntax changes. From the original syllabus of 182 learning outcomes, removing the neuroanatomy component (163), 23 learning outcomes (15%) remained unchanged, seven learning outcomes were removed and two new learning outcomes added. The remaining 133 learning outcomes were modified. All learning outcomes on the new core syllabus achieved over 90% acceptance by the panel. © 2015 Anatomical Society.

Outcomes of polio eradication activities in Uttar Pradesh, India: the Social Mobilization Network (SM Net) and Core Group Polio Project (CGPP)

PubMed Central

2011-01-01

Background The primary strategy to interrupt transmission of wild poliovirus in India is to improve supplemental immunization activities and routine immunization coverage in priority districts with a focus on 107 high-risk blocks of western Uttar Pradesh and central Bihar. Villages or urban areas with a history of wild poliovirus transmission, or hard-to-reach or resistant populations are categorized as high-risk areas within blocks. The Social Mobilization Network (SM Net) was formed in Uttar Pradesh in 2003 to support polio eradication efforts through improved planning, implementation and monitoring of social mobilization activities in those high-risk areas. In this paper, we examine the vaccination outcomes in districts of SM Net where the CORE Group works. Methods We carried out a secondary data analysis of routine monitoring information collected by the SM Net and the Government of India. These data include information about vaccination outcomes in SM Net areas and non-SM Net areas within the districts where the CORE Group operates. Statistical analysis was used to compare, between SM Net and non-SM Net areas, vaccination outcomes considered sensitive to social mobilization efforts of the SM Net. We employed Generalized Estimating Equations (GEE) statistical method to account for Intra-cluster Correlation (ICC), and used 'Quasi-likelihood under the independence model criterion (QIC)' as the model selection method. Results Vaccination outcomes in SM Net areas were as high as or higher than in non-SM Net areas. There was considerable variation in vaccination outcomes between districts. Conclusions While not conclusive, the results suggest that the social mobilization efforts of the SM Net and the CORE Group are helping to increase vaccination levels in high-risk areas of Uttar Pradesh. Vaccination outcomes in CORE Group areas were equal or higher than in non-CORE, non-SM Net areas. This occurred even though SM Net areas are those with more community resistance to polio vaccination and/or are have harder-to-reach populations than non-SM Net areas. Other likely explanations for the relatively good vaccination performance in SM Net areas are not apparent. PMID:21569256

Evaluation of the feasibility and performance of early warning scores to identify patients at risk of adverse outcomes in a low-middle income country setting

PubMed Central

Beane, Abi; De Silva, Ambepitiyawaduge Pubudu; De Silva, Nirodha; Sujeewa, Jayasingha A; Rathnayake, R M Dhanapala; Sigera, P Chathurani; Athapattu, Priyantha Lakmini; Mahipala, Palitha G; Rashan, Aasiyah; Munasinghe, Sithum Bandara; Jayasinghe, Kosala Saroj Amarasiri; Dondorp, Arjen M; Haniffa, Rashan

2018-01-01

Objective This study describes the availability of core parameters for Early Warning Scores (EWS), evaluates the ability of selected EWS to identify patients at risk of death or other adverse outcome and describes the burden of triggering that front-line staff would experience if implemented. Design Longitudinal observational cohort study. Setting District General Hospital Monaragala. Participants All adult (age >17 years) admitted patients. Main outcome measures Existing physiological parameters, adverse outcomes and survival status at hospital discharge were extracted daily from existing paper records for all patients over an 8-month period. Statistical analysis Discrimination for selected aggregate weighted track and trigger systems (AWTTS) was assessed by the area under the receiver operating characteristic (AUROC) curve. Performance of EWS are further evaluated at time points during admission and across diagnostic groups. The burden of trigger to correctly identify patients who died was evaluated using positive predictive value (PPV). Results Of the 16 386 patients included, 502 (3.06%) had one or more adverse outcomes (cardiac arrests, unplanned intensive care unit admissions and transfers). Availability of physiological parameters on admission ranged from 90.97% (95% CI 90.52% to 91.40%) for heart rate to 23.94% (95% CI 23.29% to 24.60%) for oxygen saturation. Ability to discriminate death on admission was less than 0.81 (AUROC) for all selected EWS. Performance of the best performing of the EWS varied depending on admission diagnosis, and was diminished at 24 hours prior to event. PPV was low (10.44%). Conclusion There is limited observation reporting in this setting. Indiscriminate application of EWS to all patients admitted to wards in this setting may result in an unnecessary burden of monitoring and may detract from clinician care of sicker patients. Physiological parameters in combination with diagnosis may have a place when applied on admission to help identify patients for whom increased vital sign monitoring may not be beneficial. Further research is required to understand the priorities and cues that influence monitoring of ward patients. Trial registration number NCT02523456. PMID:29703852

Children's everyday exposure to food marketing: an objective analysis using wearable cameras.

PubMed

Signal, L N; Stanley, J; Smith, M; Barr, M B; Chambers, T J; Zhou, J; Duane, A; Gurrin, C; Smeaton, A F; McKerchar, C; Pearson, A L; Hoek, J; Jenkin, G L S; Ni Mhurchu, C

2017-10-08

Over the past three decades the global prevalence of childhood overweight and obesity has increased by 47%. Marketing of energy-dense nutrient-poor foods and beverages contributes to this worldwide increase. Previous research on food marketing to children largely uses self-report, reporting by parents, or third-party observation of children's environments, with the focus mostly on single settings and/or media. This paper reports on innovative research, Kids'Cam, in which children wore cameras to examine the frequency and nature of everyday exposure to food marketing across multiple media and settings. Kids'Cam was a cross-sectional study of 168 children (mean age 12.6 years, SD = 0.5) in Wellington, New Zealand. Each child wore a wearable camera on four consecutive days, capturing images automatically every seven seconds. Images were manually coded as either recommended (core) or not recommended (non-core) to be marketed to children by setting, marketing medium, and product category. Images in convenience stores and supermarkets were excluded as marketing examples were considered too numerous to count. On average, children were exposed to non-core food marketing 27.3 times a day (95% CI 24.8, 30.1) across all settings. This was more than twice their average exposure to core food marketing (12.3 per day, 95% CI 8.7, 17.4). Most non-core exposures occurred at home (33%), in public spaces (30%) and at school (19%). Food packaging was the predominant marketing medium (74% and 64% for core and non-core foods) followed by signs (21% and 28% for core and non-core). Sugary drinks, fast food, confectionary and snack foods were the most commonly encountered non-core foods marketed. Rates were calculated using Poisson regression. Children in this study were frequently exposed, across multiple settings, to marketing of non-core foods not recommended to be marketed to children. The study provides further evidence of the need for urgent action to reduce children's exposure to marketing of unhealthy foods, and suggests the settings and media in which to act. Such action is necessary if the Commission on Ending Childhood Obesity's vision is to be achieved.

Relaxation Response–Based Yoga Improves Functioning in Young Children with Autism: A Pilot Study

PubMed Central

Rosenblatt, Lucy E.; Gorantla, Sasikanth; Torres, Jodi A.; Yarmush, Rubin S.; Rao, Surita; Park, Elyse R.; Denninger, John W.; Benson, Herbert; Fricchione, Gregory L.; Bernstein, Bruce

2011-01-01

Abstract Objectives The study objectives were to develop and objectively assess the therapeutic effect of a novel movement-based complementary and alternative medicine approach for children with an autism-spectrum disorder (ASD). Design A within-subject analysis comparing pre- to post-treatment scores on two standard measures of childhood behavioral problems was used. Settings and location The intervention and data analysis occurred at a tertiary care, medical school teaching hospital. Subjects Twenty-four (24) children aged 3–16 years with a diagnosis of an ASD comprised the study group. Intervention The efficacy of an 8-week multimodal yoga, dance, and music therapy program based on the relaxation response (RR) was developed and examined. Outcome measures The study outcome was measured using The Behavioral Assessment System for Children, Second Edition (BASC-2) and the Aberrant Behavioral Checklist (ABC). Results Robust changes were found on the BASC-2, primarily for 5–12-year-old children. Unexpectedly, the post-treatment scores on the Atypicality scale of the BASC-2, which measures some of the core features of autism, changed significantly (p=0.003). Conclusions A movement-based, modified RR program, involving yoga and dance, showed efficacy in treating behavioral and some core features of autism, particularly for latency-age children. PMID:21992466

Defining a set of standardised outcome measures for newly diagnosed patients with multiple myeloma using the Delphi consensus method: the IMPORTA project.

PubMed

Blade, Joan; Calleja, Miguel Ángel; Lahuerta, Juan José; Poveda, José Luis; de Paz, Héctor David; Lizán, Luis

2018-02-22

To define a standard set of outcomes and the most appropriate instruments to measure them for managing newly diagnosed patients with multiple myeloma (MM). A literature review and five discussion groups facilitated the design of two-round Delphi questionnaire. Delphi panellists (haematologists, hospital pharmacists and patients) were identified by the scientific committee, the Spanish Program of Haematology Treatments Foundation, the Spanish Society of Hospital Pharmacies and the Spanish Community of Patients with MM. Panellist's perception about outcomes' suitability and feasibility of use was assessed on a seven-point Likert scale. Consensus was reached when at least 75% of the respondents reached agreement or disagreement. A scientific committee led the project. Fifty-one and 45 panellists participated in the first and second Delphi rounds, respectively. Consensus was reached to use overall survival, progression-free survival, minimal residual disease and treatment response to assess survival and disease control. Panellists agreed to measure health-related quality of life, pain, performance status, fatigue, psychosocial status, symptoms, self-perception on body image, sexuality and preferences/satisfaction. However, panellist did not reach consensus about the feasibility of assessing in routine practice psychosocial status, symptoms, self-perception on body image and sexuality. Consensus was reached to collect patient-reported outcomes through the European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core questionnaire 30 (C30), three items from EORTC-QLQ-Multiple Myeloma (MY20) and EORTC-QLQ-Breast Cancer (BR23), pain Visual Analogue Scale, Morisky-Green and ad hoc questions about patients' preferences/satisfaction. A consensual standard set of outcomes for managing newly diagnosed patients with MM has been defined. The feasibility of its implementation in routine practice will be assessed in a future pilot study. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Clustering algorithms for identifying core atom sets and for assessing the precision of protein structure ensembles.

PubMed

Snyder, David A; Montelione, Gaetano T

2005-06-01

An important open question in the field of NMR-based biomolecular structure determination is how best to characterize the precision of the resulting ensemble of structures. Typically, the RMSD, as minimized in superimposing the ensemble of structures, is the preferred measure of precision. However, the presence of poorly determined atomic coordinates and multiple "RMSD-stable domains"--locally well-defined regions that are not aligned in global superimpositions--complicate RMSD calculations. In this paper, we present a method, based on a novel, structurally defined order parameter, for identifying a set of core atoms to use in determining superimpositions for RMSD calculations. In addition we present a method for deciding whether to partition that core atom set into "RMSD-stable domains" and, if so, how to determine partitioning of the core atom set. We demonstrate our algorithm and its application in calculating statistically sound RMSD values by applying it to a set of NMR-derived structural ensembles, superimposing each RMSD-stable domain (or the entire core atom set, where appropriate) found in each protein structure under consideration. A parameter calculated by our algorithm using a novel, kurtosis-based criterion, the epsilon-value, is a measure of precision of the superimposition that complements the RMSD. In addition, we compare our algorithm with previously described algorithms for determining core atom sets. The methods presented in this paper for biomolecular structure superimposition are quite general, and have application in many areas of structural bioinformatics and structural biology.

The CROWN Initiative: journal editors invite researchers to develop core outcomes in women's health.

PubMed

Leese, Henry

2014-09-01

Human Fertility is pleased to support the 'CROWN' initiative outlined below, whose aim is 'to develop core outcomes in women's health'. The editorial, which was unanimously adopted by our Editorial Board is being published by more than 50 gynaecology-obstetrics and related journals. We commend it to all our readers.

Convergent Validity of the CORE Measures with Measures of Depression for Clients in Cognitive Therapy for Depression

ERIC Educational Resources Information Center

Cahill, Jane; Barkham, Michael; Stiles, William B.; Twigg, Elspeth; Hardy, Gillian E.; Rees, Anne; Evans, Chris

2006-01-01

Clients (N = 77) undergoing cognitive therapy for depression were assessed before treatment with the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM), which encompasses domains of subjective well-being, problems, functioning, and risk of harming self or others, along with the Beck Depression Inventory-II (BDIII), the Hamilton…

Connecting Stuttering Management and Measurement: I. Core Speech Measures of Clinical Process and Outcome

ERIC Educational Resources Information Center

Shenker, Rosalee C.

2006-01-01

Background: There will always be a place for stuttering treatments designed to eliminate or reduce stuttered speech. When those treatments are required, direct speech measures of treatment process and outcome are needed in clinical practice. Aims: Based on the contents of published clinical trials of such treatments, three "core" measures of…

School Gardens Enhance Academic Performance and Dietary Outcomes in Children.

PubMed

Berezowitz, Claire K; Bontrager Yoder, Andrea B; Schoeller, Dale A

2015-08-01

Schools face increasing demands to provide education on healthy living and improve core academic performance. Although these appear to be competing concerns, they may interact beneficially. This article focuses on school garden programs and their effects on students' academic and dietary outcomes. Database searches in CABI, Web of Science, Web of Knowledge, PubMed, Education Full Text, Education Resources Information Center (ERIC), and PsychINFO were conducted through May 2013 for peer-reviewed literature related to school-day garden interventions with measures of dietary and/or academic outcomes. Among 12 identified garden studies with dietary measures, all showed increases/improvements in predictors of fruit and vegetable (FV) consumption. Seven of these also included self-reported FV intake with 5 showing an increase and 2 showing no change. Four additional interventions that included a garden component measured academic outcomes; of these, 2 showed improvements in science achievement and 1 measured and showed improvements in math scores. This small set of studies offers evidence that garden-based learning does not negatively impact academic performance or FV consumption and may favorably impact both. Additional studies with more robust experimental designs and outcome measures are necessary to understand the effects of experiential garden-based learning on children's academic and dietary outcomes. © 2015, American School Health Association.

The Geriatric ICF Core Set reflecting health-related problems in community-living older adults aged 75 years and older without dementia: development and validation.

PubMed

Spoorenberg, Sophie L W; Reijneveld, Sijmen A; Middel, Berrie; Uittenbroek, Ronald J; Kremer, Hubertus P H; Wynia, Klaske

2015-01-01

The aim of the present study was to develop a valid Geriatric ICF Core Set reflecting relevant health-related problems of community-living older adults without dementia. A Delphi study was performed in order to reach consensus (≥70% agreement) on second-level categories from the International Classification of Functioning, Disability and Health (ICF). The Delphi panel comprised 41 older adults, medical and non-medical experts. Content validity of the set was tested in a cross-sectional study including 267 older adults identified as frail or having complex care needs. Consensus was reached for 30 ICF categories in the Delphi study (fourteen Body functions, ten Activities and Participation and six Environmental Factors categories). Content validity of the set was high: the prevalence of all the problems was >10%, except for d530 Toileting. The most frequently reported problems were b710 Mobility of joint functions (70%), b152 Emotional functions (65%) and b455 Exercise tolerance functions (62%). No categories had missing values. The final Geriatric ICF Core Set is a comprehensive and valid set of 29 ICF categories, reflecting the most relevant health-related problems among community-living older adults without dementia. This Core Set may contribute to optimal care provision and support of the older population. Implications for Rehabilitation The Geriatric ICF Core Set may provide a practical tool for gaining an understanding of the relevant health-related problems of community-living older adults without dementia. The Geriatric ICF Core Set may be used in primary care practice as an assessment tool in order to tailor care and support to the needs of older adults. The Geriatric ICF Core Set may be suitable for use in multidisciplinary teams in integrated care settings, since it is based on a broad range of problems in functioning. Professionals should pay special attention to health problems related to mobility and emotional functioning since these are the most prevalent problems in community-living older adults.

Explanatory power does not equal clinical importance: study of the use of the Brief ICF Core Sets for Spinal Cord Injury with a purely statistical approach.

PubMed

Ballert, C; Oberhauser, C; Biering-Sørensen, F; Stucki, G; Cieza, A

2012-10-01

Psychometric study analyzing the data of a cross-sectional, multicentric study with 1048 persons with spinal cord injury (SCI). To shed light on how to apply the Brief Core Sets for SCI of the International Classification of Functioning, Disability and Health (ICF) by determining whether the ICF categories contained in the Core Sets capture differences in overall health. Lasso regression was applied using overall health, rated by the patients and health professionals, as dependent variables and the ICF categories of the Comprehensive ICF Core Sets for SCI as independent variables. The ICF categories that best capture differences in overall health refer to areas of life such as self-care, relationships, economic self-sufficiency and community life. Only about 25% of the ICF categories of the Brief ICF Core Sets for the early post-acute and for long-term contexts were selected in the Lasso regression and differentiate, therefore, among levels of overall health. ICF categories such as d570 Looking after one's health, d870 Economic self-sufficiency, d620 Acquisition of goods and services and d910 Community life, which capture changes in overall health in patients with SCI, should be considered in addition to those of the Brief ICF Core Sets in clinical and epidemiological studies in persons with SCI.

Excellence and evidence in staffing: a data-driven model for excellence in staffing (2nd edition).

PubMed

Baggett, Margarita; Batcheller, Joyce; Blouin, Ann Scott; Behrens, Elizabeth; Bradley, Carol; Brown, Mary J; Brown, Diane Storer; Bolton, Linda Burnes; Borromeo, Annabelle R; Burtson, Paige; Caramanica, Laura; Caspers, Barbara A; Chow, Marilyn; Christopher, Mary Ann; Clarke, Sean P; Delucas, Christine; Dent, Robert L; Disser, Tony; Eliopoulos, Charlotte; Everett, Linda Q; Garcia, Amy; Glassman, Kimberly; Goodwin, Susan; Haagenson, Deb; Harper, Ellen; Harris, Kathy; Hoying, Cheryl L; Hughes-Rease, Marsha; Kelly, Lesly; Kiger, Anna J; Kobs-Abbott, Ann; Krueger, Janelle; Larson, Jackie; March, Connie; Martin, Deborah Maust; Mazyck, Donna; Meenan, Penny; McGaffigan, Patricia; Myers, Karen K; Nell, Kate; Newcomer, Britta; Cathy, Rick; O'Rourke, Maria; Rosa, Billy; Rose, Robert; Rudisill, Pamela; Sanford, Kathy; Simpson, Roy L; Snowden, Tami; Strickland, Bob; Strohecker, Sharon; Weems, Roger B; Welton, John; Weston, Marla; Valentine, Nancy M; Vento, Laura; Yendro, Susan

2014-01-01

The Patient Protection and Affordable Care Act (PPACA, 2010) and the Institute of Medicine's (IOM, 2011) Future of Nursing report have prompted changes in the U.S. health care system. This has also stimulated a new direction of thinking for the profession of nursing. New payment and priority structures, where value is placed ahead of volume in care, will start to define our health system in new and unknown ways for years. One thing we all know for sure: we cannot afford the same inefficient models and systems of care of yesterday any longer. The Data-Driven Model for Excellence in Staffing was created as the organizing framework to lead the development of best practices for nurse staffing across the continuum through research and innovation. Regardless of the setting, nurses must integrate multiple concepts with the value of professional nursing to create new care and staffing models. Traditional models demonstrate that nurses are a commodity. If the profession is to make any significant changes in nurse staffing, it is through the articulation of the value of our professional practice within the overall health care environment. This position paper is organized around the concepts from the Data-Driven Model for Excellence in Staffing. The main concepts are: Core Concept 1: Users and Patients of Health Care, Core Concept 2: Providers of Health Care, Core Concept 3: Environment of Care, Core Concept 4: Delivery of Care, Core Concept 5: Quality, Safety, and Outcomes of Care. This position paper provides a comprehensive view of those concepts and components, why those concepts and components are important in this new era of nurse staffing, and a 3-year challenge that will push the nursing profession forward in all settings across the care continuum. There are decades of research supporting various changes to nurse staffing. Yet little has been done to move that research into practice and operations. While the primary goal of this position paper is to generate research and innovative thinking about nurse staffing across all health care settings, a second goal is to stimulate additional publications. This includes a goal of at least 20 articles in Nursing Economic$ on best practices in staffing and care models from across the continuum over the next 3 years.

A pilot Tuning Project-based national study on recently graduated medical students' self-assessment of competences--the TEST study.

PubMed

Grilo Diogo, Pedro; Barbosa, Joselina; Ferreira, Maria Amélia

2015-12-19

The Tuning Project is an initiative funded by the European Commission that developed core competences for primary medical degrees in Europe. Students' grouped self-assessments are used for program evaluation and improvement of curricula. The TEST study aimed to assess how do Portuguese medical graduates self-assess their acquisition of core competences and experiences of contact with patients in core settings according to the Tuning framework. Translation of the Tuning's competences (Clinical Practice - CP), Knowledge (K) items and Clinical Settings (CS) was performed. Questionnaires were created in paper and electronic formats and distributed to 1591 graduates from seven Portuguese medical schools (July 2014). Items were rated in a 6-point Likert scale (0-5) of levels of competence. Exploratory factor analysis (EFA) was conducted and Cronbach's alpha was used to evaluate the internal consistency of the questionnaire. Kruskal-Wallis and Dunn's tests were used for multiple comparisons. Three hundred eighty seven questionnaires were analyzed, corresponding to 24% of the target population. EFA yielded an 11-factor solution for CP and a 6-factor solution for K items. The median value of CP factors was 2.8 (p25 = 2.0; p75 = 3.5) and the median value of K factors was 2.6 (2.0; 3.2). Factor scores ranged from 1.3 (Legal principles) to 4.0 (Ethical principles). Clinical presentations, psychological aspects of illness, evidence-based medicine and promotion of health showed the highest results. Lower scores were detected in medical emergencies, practical procedures, prescribing drugs and legal principles. More than 90% of graduates experienced having contact with patients in 8 CS but only 24% of graduates had contact in all 14 CS. Graduates had the least contact with patients in the emergency rooms, intensive care units, palliative, rehabilitation and anesthetic care. Significant differences (p < 0.05) among schools were detected in 8 factors and 7 settings. We developed a valid questionnaire supporting national SWOT analysis on the acquisition of core competences in medical education. Results suggest that Portuguese graduates are not fully prepared for clinical practice. Curricular improvements in core competences and the educational development of the transition period between undergraduate and postgraduate education ought to be considered. Outcome-based program evaluation relying on graduates' grouped self-assessments contributes to inform changes in medical education.

Evaluation of Ceramic Honeycomb Core Compression Behavior at Room Temperature

NASA Technical Reports Server (NTRS)

Bird, Richard K.; Lapointe, Thomas S.

2013-01-01

Room temperature flatwise compression tests were conducted on two varieties of ceramic honeycomb core specimens that have potential for high-temperature structural applications. One set of specimens was fabricated using strips of a commercially-available thin-gage "ceramic paper" sheet molded into a hexagonal core configuration. The other set was fabricated by machining honeycomb core directly from a commercially available rigid insulation tile material. This paper summarizes the results from these tests.

Research Perspectives on Core French: A Literature Review

ERIC Educational Resources Information Center

Lapkin, Sharon; Mady, Callie; Arnott, Stephanie

2009-01-01

This article reviews the research literature on core French in three main areas: student diversity, delivery models for the core French program, and instructional approaches. These topics are put into context through a discussion of studies on community attitudes to French as a second language (FSL), dissatisfaction with core French outcomes and…

Estimation and Control for Autonomous Coring from a Rover Manipulator

NASA Technical Reports Server (NTRS)

Hudson, Nicolas; Backes, Paul; DiCicco, Matt; Bajracharya, Max

2010-01-01

A system consisting of a set of estimators and autonomous behaviors has been developed which allows robust coring from a low-mass rover platform, while accommodating for moderate rover slip. A redundant set of sensors, including a force-torque sensor, visual odometry, and accelerometers are used to monitor discrete critical and operational modes, as well as to estimate continuous drill parameters during the coring process. A set of critical failure modes pertinent to shallow coring from a mobile platform is defined, and autonomous behaviors associated with each critical mode are used to maintain nominal coring conditions. Autonomous shallow coring is demonstrated from a low-mass rover using a rotary-percussive coring tool mounted on a 5 degree-of-freedom (DOF) arm. A new architecture of using an arm-stabilized, rotary percussive tool with the robotic arm used to provide the drill z-axis linear feed is validated. Particular attention to hole start using this architecture is addressed. An end-to-end coring sequence is demonstrated, where the rover autonomously detects and then recovers from a series of slip events that exceeded 9 cm total displacement.

Surviving critical illness: what is next? An expert consensus statement on physical rehabilitation after hospital discharge.

PubMed

Major, M E; Kwakman, R; Kho, M E; Connolly, B; McWilliams, D; Denehy, L; Hanekom, S; Patman, S; Gosselink, R; Jones, C; Nollet, F; Needham, D M; Engelbert, R H H; van der Schaaf, M

2016-10-29

The study objective was to obtain consensus on physical therapy (PT) in the rehabilitation of critical illness survivors after hospital discharge. Research questions were: what are PT goals, what are recommended measurement tools, and what constitutes an optimal PT intervention for survivors of critical illness? A Delphi consensus study was conducted. Panelists were included based on relevant fields of expertise, years of clinical experience, and publication record. A literature review determined five themes, forming the basis for Delphi round one, which was aimed at generating ideas. Statements were drafted and ranked on a 5-point Likert scale in two additional rounds with the objective to reach consensus. Results were expressed as median and semi-interquartile range, with the consensus threshold set at ≤0.5. Ten internationally established researchers and clinicians participated in this Delphi panel, with a response rate of 80 %, 100 %, and 100 % across three rounds. Consensus was reached on 88.5 % of the statements, resulting in a framework for PT after hospital discharge. Essential handover information should include information on 15 parameters. A core set of outcomes should test exercise capacity, skeletal muscle strength, function in activities of daily living, mobility, quality of life, and pain. PT interventions should include functional exercises, circuit and endurance training, strengthening exercises for limb and respiratory muscles, education on recovery, and a nutritional component. Screening tools to identify impairments in other health domains and referral to specialists are proposed. A consensus-based framework for optimal PT after hospital discharge is proposed. Future research should focus on feasibility testing of this framework, developing risk stratification tools and validating core outcome measures for ICU survivors.

The relationship between the high-density lamina and precipitation in the subarctic Lake Mokoto, North Japan

NASA Astrophysics Data System (ADS)

Seto, K.

2015-12-01

Koji Seto (ReCCLE, Shimane Univ.), Hiroyuki Takata (Pusan Univ.), Kota Katsuki (KIGAM), Takeshi Sonoda (Tokyo Univ. of Agr.) In the coastal area of the Sea of Okhotsk in the east part of Hokkaido located to for subarctic zone, many brackish-water lakes are distributed. Lake Mokoto has two-layer structure of polyhaline surface waters and mixoeuhaline bottom water. The bottom water shows the anoxic conditions in summer season. In this reason, the sediments of Lake Mokoto consist of organic mud with the lamination. The 09Mk-1C and 09Mk-2C cores collected from Lake Mokoto at 2009. In the soft X-ray photograph, the cyclic lamina set is observed in their core. The cyclic lamina set consists of low-, intermedium- and high-density lamina. It is considered that this cyclic lamina set is the verve. According to the meteorological data in Abashiri region, the annually precipitation is high from August to September. Probably, the cyclic lamina set is formed by seasonal change of precipitation. In this study, we are discussed about the relationship between the high-density lamina and precipitation by sedimentologic and geochemical high-resolution analysis. The 09Mk-1C and 09Mk-2C cores collected from Lake Mokoto show the length of 1.78 to 3.87m, respectively. In 09Mk-2C core, Ta-a tephra (AD 1739) was observed at the 3.5m depths. The 09Mk-1C core consist of organic mud with the lamination in all cores. The core top 100 cm in this core shows the black (N1.5/0), and it seems to indicate the seasonal anoxic environment as present. The organic mud below 100cm depth shows black (10YR1.7/1). The sedimentation rate in 09Mk-1C core increase from late 1960's for the age of cyclic lamina set. It is suggest that supply of sediment in Lake Mokoto is increasing by land development in drainage basin. Phosphorus flux in 09Mk-1C core increase from late 1950's. The increasing of phosphorus flux may be caused by excess drainage of pollution from stock farm. In 2015, we were able to take the new core (15Mk-3C core). We have observed a new lamina set in detail, and compared with precipitation in Abashiri Region.

EXPANDING CAPD IN LOW-RESOURCE SETTINGS: A DISTANCE LEARNING APPROACH.

PubMed

Rope, Robert; Nanayakkara, Nishantha; Wazil, Abdul; Dickowita, Sewmini; Abeyeskera, Rajitha; Gunerathne, Lishanthe; Adoosoriya, Dinuka; Karunasena, Nishamani; Ratnayake, Charaka; Anand, Shuchi; Saxena, Anjali

2018-05-23

Despite growing need, treatment for end-stage renal disease is limited in low- and middle-income countries due to resource restraints. We describe the development of an educational curriculum and quality improvement program to support continuous ambulatory peritoneal dialysis (CAPD) performed primarily by non-nephrology providers in Sri Lanka. We developed a program of education, outcome tracking, and expert consultation to support providers in Kandy, Sri Lanka. Education included videos and in-person didactics covering core topics in CAPD. Event-tracking sheets recorded root causes and management of infections and hospitalizations. Conferences reviewed clinical cases and overall clinic management. We evaluated the patient census, peritonitis rates, and root causes and management of infections over 1 year. The curriculum was published through the International Society of Nephrology online academy. High provider turnover limited curriculum assessments. The CAPD patient census rose from 63 to 116 during the year. The peritonitis rate declined significantly, from 0.8 episodes per patient-year in the first 6 months to 0.4 in the latter 6 months, though the most common root causes of peritonitis, related to contamination events and hygiene, persisted. The appropriate ascertainment of culture data and prescription of antibiotics also increased. Our project supported the expansion of a CAPD program in a resource-limited setting, while also improving peritonitis outcomes. Ongoing challenges include ensuring a durable educational system for rotating providers, tracking outcomes beyond peritonitis, and formalizing management protocols. Our program can serve as an example of how established dialysis programs can support the burgeoning work of providers in resource-limited setting.

An exploration of person-centred concepts in human services: A thematic analysis of the literature.

PubMed

Waters, Rebecca A; Buchanan, Angus

2017-10-01

Being 'person-centred' in the delivery of health and human services has become synonymous with quality care, and it is a core feature of policy reform in Australia and other Western countries. This research aimed to identify the uses, definitions and characteristics of the term 'person-centred' in the ageing, mental health and disability literature. A thematic analysis identified seven common core themes of person-centredness: honouring the person, being in relationship, facilitating participation and engagement, social inclusion/citizenship, experiencing compassionate love, being strengths/capacity focussed, and organisational characteristics. These suggest a set of higher-order experiences for people that are translated differently in different human services. There is no common definition of what it means to be person-centred, despite being a core feature of contemporary health and human service policy, and this suggests that its inclusion facilitates further misunderstanding and misinterpretation. A common understanding and policy conceptualisation of person-centredness is likely to support quality outcomes in service delivery especially where organisations work across human service groups. Further research into the application and service expressions of being 'person-centred' in context is necessary. Copyright © 2017 Elsevier B.V. All rights reserved.

Primary Health Care as a Foundation for Strengthening Health Systems in Low- and Middle-Income Countries.

PubMed

Bitton, Asaf; Ratcliffe, Hannah L; Veillard, Jeremy H; Kress, Daniel H; Barkley, Shannon; Kimball, Meredith; Secci, Federica; Wong, Ethan; Basu, Lopa; Taylor, Chelsea; Bayona, Jaime; Wang, Hong; Lagomarsino, Gina; Hirschhorn, Lisa R

2017-05-01

Primary health care (PHC) has been recognized as a core component of effective health systems since the early part of the twentieth century. However, despite notable progress, there remains a large gap between what individuals and communities need, and the quality and effectiveness of care delivered. The Primary Health Care Performance Initiative (PHCPI) was established by an international consortium to catalyze improvements in PHC delivery and outcomes in low- and middle-income countries through better measurement and sharing of effective models and practices. PHCPI has developed a framework to illustrate the relationship between key financing, workforce, and supply inputs, and core primary health care functions of first-contact accessibility, comprehensiveness, coordination, continuity, and person-centeredness. The framework provides guidance for more effective assessment of current strengths and gaps in PHC delivery through a core set of 25 key indicators ("Vital Signs"). Emerging best practices that foster high-performing PHC system development are being codified and shared around low- and high-income countries. These measurement and improvement approaches provide countries and implementers with tools to assess the current state of their PHC delivery system and to identify where cross-country learning can accelerate improvements in PHC quality and effectiveness.

Registration status and outcome reporting of trials published in core headache medicine journals.

PubMed

Rayhill, Melissa L; Sharon, Roni; Burch, Rebecca; Loder, Elizabeth

2015-11-17

To evaluate randomized controlled trial (RCT) registration and outcome reporting compliance in core headache medicine journals. We identified RCTs published in core journals (Headache, Cephalalgia, and the Journal of Headache and Pain) from 2005 through 2014. We searched articles for trial registration numbers, which were verified in the corresponding trial registry. We categorized trial funding sources as industry, academic, government, or mixed. We contacted corresponding authors to assess reasons for nonregistration. We evaluated whether primary outcomes in trial registries matched those in corresponding publications. The journals published 225 RCTs over the study period. Fifty-eight of 225 (26%) reported a trial registration number in the article that could be linked to a corresponding registry entry. Trial registration rates increased over the 9 years of the study. Forty-six of 118 (39%) of industry-funded studies were registered compared with 27% of academic and 0% of government-funded studies. Only 5% of RCTs were prospectively registered, reported primary outcomes identical to those in the trial registry, and did not report unacknowledged post hoc outcomes. The most common reason for nonregistration was lack of awareness. Only about a quarter of the articles published in the core headache medicine journals are compliant with trial registration, but compliance has increased over time. Selective reporting of outcomes remains a problem, and very few trials met all 3 reporting standards assessed in this study. Efforts to improve the quality of trial reporting in the headache literature should continue. © 2015 American Academy of Neurology.

Parallelized computation for computer simulation of electrocardiograms using personal computers with multi-core CPU and general-purpose GPU.

PubMed

Shen, Wenfeng; Wei, Daming; Xu, Weimin; Zhu, Xin; Yuan, Shizhong

2010-10-01

Biological computations like electrocardiological modelling and simulation usually require high-performance computing environments. This paper introduces an implementation of parallel computation for computer simulation of electrocardiograms (ECGs) in a personal computer environment with an Intel CPU of Core (TM) 2 Quad Q6600 and a GPU of Geforce 8800GT, with software support by OpenMP and CUDA. It was tested in three parallelization device setups: (a) a four-core CPU without a general-purpose GPU, (b) a general-purpose GPU plus 1 core of CPU, and (c) a four-core CPU plus a general-purpose GPU. To effectively take advantage of a multi-core CPU and a general-purpose GPU, an algorithm based on load-prediction dynamic scheduling was developed and applied to setting (c). In the simulation with 1600 time steps, the speedup of the parallel computation as compared to the serial computation was 3.9 in setting (a), 16.8 in setting (b), and 20.0 in setting (c). This study demonstrates that a current PC with a multi-core CPU and a general-purpose GPU provides a good environment for parallel computations in biological modelling and simulation studies. Copyright 2010 Elsevier Ireland Ltd. All rights reserved.

Variations in reporting of outcomes in randomized trials on diet and physical activity in pregnancy: A systematic review.

PubMed

Rogozińska, Ewelina; Marlin, Nadine; Yang, Fen; Dodd, Jodie M; Guelfi, Kym; Teede, Helena; Surita, Fernanda; Jensen, Dorte M; Geiker, Nina R W; Astrup, Arne; Yeo, SeonAe; Kinnunen, Tarja I; Stafne, Signe N; Cecatti, Jose G; Bogaerts, Annick; Hauner, Hans; Mol, Ben W; Scudeller, Tânia T; Vinter, Christina A; Renault, Kristina M; Devlieger, Roland; Thangaratinam, Shakila; Khan, Khalid S

2017-07-01

Trials on diet and physical activity in pregnancy report on various outcomes. We aimed to assess the variations in outcomes reported and their quality in trials on lifestyle interventions in pregnancy. We searched major databases without language restrictions for randomized controlled trials on diet and physical activity-based interventions in pregnancy up to March 2015. Two independent reviewers undertook study selection and data extraction. We estimated the percentage of papers reporting 'critically important' and 'important' outcomes. We defined the quality of reporting as a proportion using a six-item questionnaire. Regression analysis was used to identify factors affecting this quality. Sixty-six randomized controlled trials were published in 78 papers (66 main, 12 secondary). Gestational diabetes (57.6%, 38/66), preterm birth (48.5%, 32/66) and cesarian section (60.6%, 40/66), were the commonly reported 'critically important' outcomes. Gestational weight gain (84.5%, 56/66) and birth weight (87.9%, 58/66) were reported in most papers, although not considered critically important. The median quality of reporting was 0.60 (interquartile range 0.25, 0.83) for a maximum score of one. Study and journal characteristics did not affect quality. Many studies on lifestyle interventions in pregnancy do not report critically important outcomes, highlighting the need for core outcome set development. © 2017 Japan Society of Obstetrics and Gynecology.

Leveraging Behavioral Economics to Improve Heart Failure Care and Outcomes.

PubMed

Chang, Leslie L; DeVore, Adam D; Granger, Bradi B; Eapen, Zubin J; Ariely, Dan; Hernandez, Adrian F

2017-08-22

Behavioral challenges are often present in human illness, so behavioral economics is increasingly being applied in healthcare settings to better understand why patients choose healthy or unhealthy behaviors. The application of behavioral economics to healthcare settings parallels recent shifts in policy and reimbursement structures that hold providers accountable for outcomes that are dependent on patient behaviors. Numerous studies have examined the application of behavioral economics principles to policy making and health behaviors, but there are limited data on applying these concepts to the management of chronic conditions, such as heart failure (HF). Given its increasing prevalence and high associated cost of care, HF is a paradigm case for studying novel approaches to improve health care; therefore, if we can better understand why patients with HF make the choices they do, then we may be more poised to help them manage their medications, influence daily behaviors, and encourage healthy decision making. In this article, we will give a brief explanation of the core behavioral economics concepts that apply to patients with HF. We will also examine how to craft these concepts into tools such as financial incentives and social networks that may improve the management of patients with HF. We believe that behavioral economics can help us understand barriers to change, encourage positive behaviors, and offer additional approaches to improving the outcomes of patients with HF. © 2017 American Heart Association, Inc.

Identifying core NANDA-I nursing diagnoses, NIC interventions, NOC outcomes, and NNN linkages for heart failure.

PubMed

Park, Hyejin

2014-02-01

The purpose of the study was to identify the core nursing diagnoses, interventions, outcomes, and linkages using standardized nursing terminologies for patients with heart failure (HF). For this study a retrospective descriptive design was used. The frequently used NANDA-I, NIC, NOC, and NNN linkages were identified through 272 inpatient records of patients discharged with HF in a midwestern community. The findings indicate that the top 10 NANDA-I, NIC, and NOC accounted for more than 50% of nursing diagnoses, interventions, and outcomes. The most frequently used top 10 NNN linkages were identified for patients with HF. The identified core NANDA-I, NIC, NOC, and NNN linkages for HF from this study provide scope of practice of nurses working in HF clinics. © 2013 NANDA International, Inc.

SU-F-T-237: The Imaging and Radiation Oncology Core (IROC) Cooperatives Activities Supporting the NCI’s National Clinical Trial Network

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

Followill, D; Galvin, J; Michalski, J

Purpose: The Imaging and Radiation Oncology Core (IROC) Cooperative has been active for the past two years supporting the National Clinical Trial Network and the details of that support are reported. Methods: There are six QA centers (Houston, Ohio, Philadelphia-RT, Philadelphia-DI, Rhode Island, St. Louis) providing an integrated RT and DI quality control program in support of the NCI’s clinical trials. The QA Center’s efforts are focused on assuring high quality data for clinical trials designed to improve the clinical outcomes for cancer patients worldwide. This program is administered through five core services: site qualification, trial design support, credentialing, datamore » management, and case review. Results: IROC currently provides core support for 172 NCTN trials with RT, DI and RT/DI components. Many of these trials were legacy trial from the previous cooperative group program. IROC monitors nearly 1800 RT photon and 20 proton institutions. Over 28,000 beams outputs were monitored with 8% of the sites requiring repeat audits due to beam out of criteria. As part of credentialing, 950 QA phantoms have been irradiated, 515 imaging modalities evaluated and almost 4000 credentialing letters have been issued. In just year 2, 5290 RT and 4934 DI patient datasets were received (many using TRIAD) by IROC QA Centers to be prepared for review. During the past 2 years, a total of 6300 RT cases and 19,000 DI image sets were reviewed by IROC technical staff. To date, IROC has published 36 manuscripts. Conclusion: The QA services provided by IROC are numerous and are continually being evaluated for effectiveness, harmonized across all NCTN Groups and administered in an efficient and timely manner to enhance accurate and per protocol trial data submission. These efforts increase each NCTN Group’s ability to derive meaningful outcomes from their clinical trials. This work was supported by DHHS NIH grant 5U24CA180803.« less

Antimicrobial stewardship programs: interventions and associated outcomes.

PubMed

Patel, Dimple; Lawson, Wendy; Guglielmo, B Joseph

2008-04-01

Guidelines regarding antimicrobial stewardship programs recommend an infectious diseases-trained physician and an infectious diseases-trained pharmacist as core members. Inclusion of clinical microbiologists, infection-control practitioners, information systems experts and hospital epidemiologists is considered optimal. Recommended stewardship interventions include prospective audit and intervention, formulary restriction, education, guideline development, clinical pathway development, antimicrobial order forms and the de-escalation of therapy. The primary outcome associated with these interventions has been the associated cost savings; however, few published investigations have taken into account the overall cost of the intervention. Over the past 5 years, there has been an increased focus upon interventions intended to decrease bacterial resistance or reduce superinfection, including infections associated with Clostridium difficile colitis. Few programs have been associated with a reduction in antimicrobial drug adverse events. Antimicrobial stewardship programs are becoming increasingly associated with clear benefits and will be integral in the in-patient healthcare setting.

Analysis of the Team-Based Learning Literature: TBL Comes of Age

PubMed Central

Haidet, Paul; Kubitz, Karla; McCormack, Wayne T.

2015-01-01

Team-based learning, or TBL, is an application-oriented teaching method that combines small- and large-group learning by incorporating multiple small groups into a large group setting. It has been increasingly used in postsecondary and professional education over the past two decades. Given this increasing usage, many faculty wonder about the effects TBL has on learning outcomes. The authors performed a review and synthesis on the educational literature with respect to TBL to examine the quality of their descriptions of core TBL elements, then constructed narrative summaries of these selected articles. Their analysis demonstrated early evidence of positive educational outcomes in terms of knowledge acquisition, participation and engagement, and team performance. The authors conclude that the TBL literature is at an important maturation point, where more rigorous testing and study of additional questions relating to the method are needed, as well as more accurate reporting of TBL implementation. PMID:26568668

78 FR 71617 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-29

... agencies that have prescription drug programs are required to perform prospective and retrospective drug... study to validate the core competency set among the workforce; (2) establishing the core competency set...

Establishing the situated features associated with perceived stress

PubMed Central

Lebois, Lauren A.M.; Hertzog, Christopher; Slavich, George M.; Barrett, Lisa Feldman; Barsalou, Lawrence W.

2016-01-01

We propose that the domain general process of categorization contributes to the perception of stress. When a situation contains features associated with stressful experiences, it is categorized as stressful. From the perspective of situated cognition, the features used to categorize experiences as stressful are the features typically true of stressful situations. To test this hypothesis, we asked participants to evaluate the perceived stress of 572 imagined situations, and to also evaluate each situation for how much it possessed 19 features potentially associated with stressful situations and their processing (e.g., self-threat, familiarity, visual imagery, outcome certainty). Following variable reduction through factor analysis, a core set of 8 features associated with stressful situations—expectation violation, self-threat, coping efficacy, bodily experience, arousal, negative valence, positive valence, and perseveration—all loaded on a single Core Stress Features factor. In a multilevel model, this factor and an Imagery factor explained 88% of the variance in judgments of perceived stress, with significant random effects reflecting differences in how individual participants categorized stress. These results support the hypothesis that people categorize situations as stressful to the extent that typical features of stressful situations are present. To our knowledge, this is the first attempt to establish a comprehensive set of features that predicts perceived stress. PMID:27288834

Charting the trajectory of domestic violence policy change in the Republic of Ireland since the mid-1990s - a path towards integration?

PubMed

Kearns, Noreen; Coen, Liam

2014-07-01

This paper assesses the policy developments pertaining to the implementation of an integrated approach to domestic violence over the past 15 years. The contextual setting is outlined in terms of the international policy response to the problem of domestic violence based on an ecological perspective. Periods of core strategic policy and related structural developments are considered illustrating the Irish experience of domestic violence policy-making and service provision. The value of adopting an integrated approach to domestic violence based on the rationale of improving strategic policy formulation, coordinating service provision and facilitating joined-up governance is set out. The core facilitators and challenges associated with such an approach are described. The policy framework and restructured landscape of domestic violence in Ireland has undergone significant change over the past decade and a half. The paper uses a three-dimensional matrix of domestic violence policy development and service integration as a means of addressing horizontal, vertical and resource aspects of collaboration and integration. While the changes have been characterised by significant phases of fluctuation in terms of coordinated action and the situation currently appears promising, however it is too early to judge the outcomes of the most recent reforms.

Charting the trajectory of domestic violence policy change in the Republic of Ireland since the mid-1990s – a path towards integration?

PubMed Central

Kearns, Noreen; Coen, Liam

2014-01-01

Introduction This paper assesses the policy developments pertaining to the implementation of an integrated approach to domestic violence over the past 15 years. The contextual setting is outlined in terms of the international policy response to the problem of domestic violence based on an ecological perspective. Description of policy and case Periods of core strategic policy and related structural developments are considered illustrating the Irish experience of domestic violence policy-making and service provision. The value of adopting an integrated approach to domestic violence based on the rationale of improving strategic policy formulation, coordinating service provision and facilitating joined-up governance is set out. The core facilitators and challenges associated with such an approach are described. Analysis and conclusion The policy framework and restructured landscape of domestic violence in Ireland has undergone significant change over the past decade and a half. The paper uses a three-dimensional matrix of domestic violence policy development and service integration as a means of addressing horizontal, vertical and resource aspects of collaboration and integration. While the changes have been characterised by significant phases of fluctuation in terms of coordinated action and the situation currently appears promising, however it is too early to judge the outcomes of the most recent reforms. PMID:25337062

Promoting a Culture of Safety as a Patient Safety Strategy

PubMed Central

Weaver, Sallie J.; Lubomksi, Lisa H.; Wilson, Renee F.; Pfoh, Elizabeth R.; Martinez, Kathryn A.; Dy, Sydney M.

2015-01-01

Developing a culture of safety is a core element of many efforts to improve patient safety and care quality. This systematic review identifies and assesses interventions used to promote safety culture or climate in acute care settings. The authors searched MEDLINE, CINAHL, PsycINFO, Cochrane, and EMBASE to identify relevant English-language studies published from January 2000 to October 2012. They selected studies that targeted health care workers practicing in inpatient settings and included data about change in patient safety culture or climate after a targeted intervention. Two raters independently screened 3679 abstracts (which yielded 33 eligible studies in 35 articles), extracted study data, and rated study quality and strength of evidence. Eight studies included executive walk rounds or interdisciplinary rounds; 8 evaluated multicomponent, unit-based interventions; and 20 included team training or communication initiatives. Twenty-nine studies reported some improvement in safety culture or patient outcomes, but measured outcomes were highly heterogeneous. Strength of evidence was low, and most studies were pre–post evaluations of low to moderate quality. Within these limits, evidence suggests that interventions can improve perceptions of safety culture and potentially reduce patient harm. PMID:23460092

Variations in structures, processes and outcomes of community mental health teams for older people: a systematic review of the literature.

PubMed

Abendstern, M; Harrington, V; Brand, C; Tucker, S; Wilberforce, M; Challis, D

2012-01-01

In the UK and elsewhere, specialist community mental health teams (CMHTs) are central to the provision of comprehensive services for older people with mental ill health. Recent guidance documents suggest a core set of attributes that such teams should encompass. This article reports on a systematic literature review undertaken to collate existing evidence regarding the structures and processes of CMHTs for older people and to evaluate evidence linking approaches to effectiveness. Relevant publications were identified via systematic searches, both electronic and manual. Searches were limited to the UK for descriptions of organisation and practice but included international literature where comparisons between different CMHT arrangements were evaluated. Empirical, peer-reviewed studies from 1989 onward were included, extended to non peer-reviewed nationally or regionally representative reports, published after 1998, for the descriptive element. Forty-five studies met inclusion criteria of which seven provided comparative outcome data. All but one were UK based. The most robust evidence related to research conducted in exemplar teams. Limited evidence was found regarding the effectiveness of many of the core attributes recommended in policy directives although their presence was reported in much of the literature. The contrast between presentation and evaluation of attributes is stark. Whilst some gaps can be filled from related fields, further research is required that moves beyond description to evaluation of the impact of team design on service user outcomes in order to inform future policy directives and practice guidance. A framework for an evidence-based model of CMHTs for older people is provided.

How to get the most out of your orthopaedic fellowship: thinking about practice-based learning.

PubMed

Templeman, David

2012-09-01

Practice-based learning and improvement is an important skill set to develop during an orthopaedic trauma fellowship and is 1 of the 6 core competencies stated by the ACGME. The review of clinic cases is best done using a few simple models to develop a structured approach for studying cases. Three common sense and easy-to-use strategies to improve clinical practice are as follows: performing each case three times, studying the 4 quadrants of patient outcomes, and the application of the Pareto 80/20 rule. These principles help to develop a structured approach for analyzing and thinking about practice-based experiences.

The efficacy of a supervised and a home-based core strengthening programme in adults with poor core stability: a three-arm randomised controlled trial.

PubMed

Chuter, V H; de Jonge, X A K Janse; Thompson, B M; Callister, R

2015-03-01

Poor core stability is linked to a range of musculoskeletal pathologies and core-strengthening programmes are widely used as treatment. Treatment outcomes, however, are highly variable, which may be related to the method of delivery of core strengthening programmes. We investigated the effect of identical 8 week core strengthening programmes delivered as either supervised or home-based on measures of core stability. Participants with poor core stability were randomised into three groups: supervised (n=26), home-based (n=26) or control (n=26). Primary outcomes were the Sahrmann test and the Star Excursion Balance Test (SEBT) for dynamic core stability and three endurance tests (side-bridge, flexor and Sorensen) for static core stability. The exercise programme was devised and supervised by an exercise physiologist. Analysis of covariance on the change from baseline over the 8 weeks showed that the supervised group performed significantly better on all core stability measures than both the home-based and control group. The home-based group produced significant improvements compared to the control group in all static core stability tests, but not in most of the dynamic core stability tests (Sahrmann test and two out of three directions of the SEBT). Our results support the use of a supervised core-strengthening programme over a home-based programme to maximise improvements in core stability, especially in its dynamic aspects. Based on our findings in healthy individuals with low core stability, further research is recommended on potential therapeutic benefits of supervised core-strengthening programmes for pathologies associated with low core stability. ACTRN12613000233729. 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.

Effects of Ambient Temperature and Forced-air Warming on Intraoperative Core Temperature: A Factorial Randomized Trial.

PubMed

Pei, Lijian; Huang, Yuguang; Xu, Yiyao; Zheng, Yongchang; Sang, Xinting; Zhou, Xiaoyun; Li, Shanqing; Mao, Guangmei; Mascha, Edward J; Sessler, Daniel I

2018-05-01

The effect of ambient temperature, with and without active warming, on intraoperative core temperature remains poorly characterized. The authors determined the effect of ambient temperature on core temperature changes with and without forced-air warming. In this unblinded three-by-two factorial trial, 292 adults were randomized to ambient temperatures 19°, 21°, or 23°C, and to passive insulation or forced-air warming. The primary outcome was core temperature change between 1 and 3 h after induction. Linear mixed-effects models assessed the effects of ambient temperature, warming method, and their interaction. A 1°C increase in ambient temperature attenuated the negative slope of core temperature change 1 to 3 h after anesthesia induction by 0.03 (98.3% CI, 0.01 to 0.06) °Ccore/(h°Cambient) (P < 0.001), for patients who received passive insulation, but not for those warmed with forced-air (-0.01 [98.3% CI, -0.03 to 0.01] °Ccore/[h°Cambient]; P = 0.40). Final core temperature at the end of surgery increased 0.13°C (98.3% CI, 0.07 to 0.20; P < 0.01) per degree increase in ambient temperature with passive insulation, but was unaffected by ambient temperature during forced-air warming (0.02 [98.3% CI, -0.04 to 0.09] °Ccore/°Cambient; P = 0.40). After an average of 3.4 h of surgery, core temperature was 36.3° ± 0.5°C in each of the forced-air groups, and ranged from 35.6° to 36.1°C in passively insulated patients. Ambient intraoperative temperature has a negligible effect on core temperature when patients are warmed with forced air. The effect is larger when patients are passively insulated, but the magnitude remains small. Ambient temperature can thus be set to comfortable levels for staff in patients who are actively warmed.

Evaluation of 2 Heat-Mitigation Methods in Army Trainees

PubMed Central

Sefton, JoEllen M.; McAdam, J. S.; Pascoe, David D.; Lohse, K. R.; Banda, Robert L.; Henault, Corbin B.; Cherrington, Andrew R.; Adams, N. E.

2016-01-01

Context: Heat injury is a significant threat to military trainees. Different methods of heat mitigation are in use across military units. Mist fans are 1 of several methods used in the hot and humid climate of Fort Benning, Georgia. Objectives: To determine if (1) the mist fan or the cooling towel effectively lowered participant core temperature in the humid environment found at Fort Benning and (2) the mist fan or the cooling towel presented additional physiologic or safety benefits or detriments when used in this environment. Design: Randomized controlled clinical trial. Setting: Laboratory environmental chamber. Patients or Other Participants: Thirty-five physically active men aged 19 to 35 years. Intervention(s): (1) Mist fan, (2) commercial cooling towel, (3) passive-cooling (no intervention) control. All treatments lasted 20 minutes. Participants ran on a treadmill at 60% V̇o2max. Main Outcome Measure(s): Rectal core temperature, heart rate, thermal comfort, perceived temperature, perceived wetness, and blood pressure. Results: Average core temperature increased during 20 minutes of cooling (F1,28 = 64.76, P < .001, ηp2 = 0.70), regardless of group (F1,28 = 3.41, P = .08, ηp2 = 0.11) or condition (F1,28 < 1.0). Core temperature, heart rate, and blood pressure did not differ among the 3 conditions. Perceived temperature during 20 minutes of cooling decreased (F1,30 = 141.19, P < .001, ηp2 = 0.83) regardless of group or condition. Perceived temperature was lower with the mist-fan treatment than with the control treatment (F1,15 = 7.38, P = .02, ηp2 = 0.32). The mist-fan group perceived themselves to be cooler even at elevated core temperatures. Conclusions: The mist fan and cooling towel were both ineffective at lowering core temperature. Core temperature continued to increase after exercise in all groups. The mist fan produced feelings of coolness while the core temperature remained elevated, possibly increasing the risk of heat illness. PMID:27710091

Game-based, portable, upper extremity rehabilitation in chronic stroke.

PubMed

Schuck, Sarah O; Whetstone, Amy; Hill, Valerie; Levine, Peter; Page, Stephen J

2011-01-01

This case series pilot study evaluates the efficacy of the Core:Tx gaming device on 2 chronic stroke survivors. Intervention was provided 3 times a week for 3 weeks. Outcome measures, administered 1 week before and 1 week after intervention, included the Stroke Impact Scale (SIS), the Canadian Occupational Performance Measure (COPM), the Fugl-Meyer Assessment of Motor Recovery (Fugl-Meyer [FM]), and the Box and Block Test (BB). Participant A exhibited an 11-point increase on the SIS, a 1.2-point change on each of the performance and satisfaction scores of the COPM, a 1-point increase on the FM, and no change on the BB. Participant B exhibited a 3-point increase on the SIS and no change on the COPM, FM, or BB. The participants experienced increased quality of life, a greater propensity to use their affected arm, and enhanced task performance without exhibiting motor changes. Additionally, the Core:Tx gaming device was reported by the participants to be a motivating modality in the therapy setting.

Evaluation of outcome measures for use in clinical practice for adults with musculoskeletal conditions of the knee: a systematic review.

PubMed

Howe, Tracey E; Dawson, Lesley J; Syme, Grant; Duncan, Louise; Reid, Judith

2012-04-01

This systematic review reported on the clinimetric properties of outcome measures for use in clinical practice for adults with musculoskeletal conditions of the knee. A systematic search was performed in Medline, EMBASE, Cinahl and AMED to identify studies examining the clinimetric properties of outcome measures for adults undergoing conservative treatment of ligament injuries, meniscal lesions, patellofemoral pain and osteoarthritis of the knee. Outcomes measures taking less than 20 min to administer and requiring minimal equipment and space were included. Pairs of authors used a checklist to record the characteristics of the outcome measures, their reported clinimetric properties and the demographics of the study populations. The OMERACT filters of 'truth' and 'discrimination' were applied to the data for each outcome measure by an expert panel. Forty-seven studies were included evaluating 37 outcome measures. Ten outcome measures had adequate supporting evidence for 'truth' and 'discrimination': AAOS, AKPS, goniometer measurement, IKDC, KOOS, LEFS, Lysholm, Tegner, WOMAC and WOMET. However none of the outcome measures had been comprehensively tested across all clinimetric properties. Despite the widespread use of some outcome measures in clinical practice and primary research, data on the clinimetric properties were available for only 37 and of these only 10 had adequate supporting evidence for use in this population. However, before a core set of outcome measures can be recommended use in clinical practice, for adults with musculoskeletal conditions of the knee, consensus should be obtained on 'feasibility' in terms of burden on the clinician and the participant. Copyright © 2011 Elsevier Ltd. All rights reserved.

Content Validity of the Comprehensive ICF Core Set for Multiple Sclerosis from the Perspective of Speech and Language Therapists

ERIC Educational Resources Information Center

Renom, Marta; Conrad, Andrea; Bascuñana, Helena; Cieza, Alarcos; Galán, Ingrid; Kesselring, Jürg; Coenen, Michaela

2014-01-01

Background: The Comprehensive International Classification of Functioning, Disability and Health (ICF) Core Set for Multiple Sclerosis (MS) is a comprehensive framework to structure the information obtained in multidisciplinary clinical settings according to the biopsychosocial perspective of the International Classification of Functioning,…

The effects of isolated and integrated 'core stability' training on athletic performance measures: a systematic review.

PubMed

Reed, Casey A; Ford, Kevin R; Myer, Gregory D; Hewett, Timothy E

2012-08-01

Core stability training, operationally defined as training focused to improve trunk and hip control, is an integral part of athletic development, yet little is known about its direct relation to athletic performance. This systematic review focuses on identification of the association between core stability and sports-related performance measures. A secondary objective was to identify difficulties encountered when trying to train core stability with the goal of improving athletic performance. A systematic search was employed to capture all articles related to athletic performance and core stability training that were identified using the electronic databases MEDLINE, CINAHL and SPORTDiscus™ (1982-June 2011). A systematic approach was used to evaluate 179 articles identified for initial review. Studies that performed an intervention targeted toward the core and measured an outcome related to athletic or sport performances were included, while studies with a participant population aged 65 years or older were excluded. Twenty-four in total met the inclusionary criteria for review. Studies were evaluated using the Physical Therapy Evidence Database (PEDro) scale. The 24 articles were separated into three groups, general performance (n = 8), lower extremity (n = 10) and upper extremity (n = 6), for ease of discussion. In the majority of studies, core stability training was utilized in conjunction with more comprehensive exercise programmes. As such, many studies saw improvements in skills of general strengths such as maximum squat load and vertical leap. Surprisingly, not all studies reported measurable increases in specific core strength and stability measures following training. Additionally, investigations that targeted the core as the primary goal for improved outcome of training had mixed results. Core stability is rarely the sole component of an athletic development programme, making it difficult to directly isolate its affect on athletic performance. The population biases of some studies of athletic performance also confound the results. Targeted core stability training provides marginal benefits to athletic performance. Conflicting findings and the lack of a standardization for measurement of outcomes and training focused to improve core strength and stability pose difficulties. Because of this, further research targeted to determine this relationship is necessary to better understand how core strength and stability affect athletic performance.

Computed Tomographic Perfusion Predicts Poor Outcomes in a Randomized Trial of Endovascular Therapy.

PubMed

Wannamaker, Robert; Guinand, Taurian; Menon, Bijoy K; Demchuk, Andrew; Goyal, Mayank; Frei, Donald; Bharatha, Aditya; Jovin, Tudor G; Shankar, Jai; Krings, Timo; Baxter, Blaise; Holmstedt, Christine; Swartz, Richard; Dowlatshahi, Dar; Chan, Richard; Tampieri, Donatella; Choe, Hana; Burns, Paul; Gentile, Nina; Rempel, Jeremy; Shuaib, Ashfaq; Buck, Brian; Bivard, Andrew; Hill, Michael; Butcher, Kenneth

2018-06-01

In the ESCAPE trial (Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion with Emphasis on Minimizing CT to Recanalization Times), patients with large vessel occlusions and small infarct cores identified with computed tomography (CT)/CT angiography were randomized to endovascular therapy or standard of care. CT perfusion (CTP) was obtained in some cases but was not used to select patients. We tested the hypothesis that patients with penumbral CTP patterns have higher rates of good clinical outcome. All CTP data acquired in ESCAPE patients were analyzed centrally using a semiautomated perfusion threshold-based approach. A penumbral pattern was defined as an infarct core <70 mL, penumbral volume >15 mL, and a total hypoperfused volume:core volume ratio of >1.8. The primary outcome was good functional outcome at 90 days (modified Rankin Scale score, 0-2). CTP was acquired in 138 of 316 ESCAPE patients. Penumbral patterns were present in 116 of 128 (90.6%) of patients with interpretable CTP data. The rate of good functional outcome in penumbral pattern patients (53 of 114; 46%) was higher than that in nonpenumbral patients (2 of 12; 17%; P =0.041). In penumbral patients, endovascular therapy increased the likelihood of a good clinical outcome (34 of 58; 57%) compared with those in the control group (19 of 58; 33%; odds ratio, 2.68; 95% confidence interval, 1.25-5.76; P =0.011). Only 3 of 12 nonpenumbral patients were randomized to the endovascular group, preventing an analysis of treatment effect. The majority of patients with CTP imaging in the ESCAPE trial had penumbral patterns, which were associated with better outcomes overall. Patients with penumbra treated with endovascular therapy had the greatest odds of good functional outcome. Nonpenumbral patients were much less likely to achieve good outcomes. © 2018 American Heart Association, Inc.

Enhanced recovery after surgery: Current research insights and future direction

PubMed Central

Abeles, Aliza; Kwasnicki, Richard Mark; Darzi, Ara

2017-01-01

Since the concept of enhanced recovery after surgery (ERAS) was introduced in the late 1990s the idea of implementing specific interventions throughout the peri-operative period to improve patient recovery has been proven to be beneficial. Minimally invasive surgery is an integral component to ERAS and has dramatically improved post-operative outcomes. ERAS can be applicable to all surgical specialties with the core generic principles used together with added specialty specific interventions to allow for a comprehensive protocol, leading to improved clinical outcomes. Diffusion of ERAS into mainstream practice has been hindered due to minimal evidence to support individual facets and lack of method for monitoring and encouraging compliance. No single outcome measure fully captures recovery after surgery, rather multiple measures are necessary at each stage. More recently the pre-operative period has been the target of a number of strategies to improve clinical outcomes, described as prehabilitation. Innovation of technology in the surgical setting is also providing opportunities to overcome the challenges within ERAS, e.g., the use of wearable activity monitors to record information and provide feedback and motivation to patients peri-operatively. Both modernising ERAS and providing evidence for key strategies across specialties will ultimately lead to better, more reliable patient outcomes. PMID:28289508

2016 American College of Rheumatology/European League Against Rheumatism Criteria for Minimal, Moderate, and Major Clinical Response in Adult Dermatomyositis and Polymyositis: An International Myositis Assessment and Clinical Studies Group/Paediatric Rheumatology International Trials Organisation Collaborative Initiative.

PubMed

Aggarwal, Rohit; Rider, Lisa G; Ruperto, Nicolino; Bayat, Nastaran; Erman, Brian; Feldman, Brian M; Oddis, Chester V; Amato, Anthony A; Chinoy, Hector; Cooper, Robert G; Dastmalchi, Maryam; Fiorentino, David; Isenberg, David; Katz, James D; Mammen, Andrew; de Visser, Marianne; Ytterberg, Steven R; Lundberg, Ingrid E; Chung, Lorinda; Danko, Katalin; García-De la Torre, Ignacio; Song, Yeong Wook; Villa, Luca; Rinaldi, Mariangela; Rockette, Howard; Lachenbruch, Peter A; Miller, Frederick W; Vencovsky, Jiri

2017-05-01

To develop response criteria for adult dermatomyositis (DM) and polymyositis (PM). Expert surveys, logistic regression, and conjoint analysis were used to develop 287 definitions using core set measures. Myositis experts rated greater improvement among multiple pairwise scenarios in conjoint analysis surveys, where different levels of improvement in 2 core set measures were presented. The PAPRIKA (Potentially All Pairwise Rankings of All Possible Alternatives) method determined the relative weights of core set measures and conjoint analysis definitions. The performance characteristics of the definitions were evaluated on patient profiles using expert consensus (gold standard) and were validated using data from a clinical trial. The nominal group technique was used to reach consensus. Consensus was reached for a conjoint analysis-based continuous model using absolute percent change in core set measures (physician, patient, and extramuscular global activity, muscle strength, Health Assessment Questionnaire, and muscle enzyme levels). A total improvement score (range 0-100), determined by summing scores for each core set measure, was based on improvement in and relative weight of each core set measure. Thresholds for minimal, moderate, and major improvement were ≥20, ≥40, and ≥60 points in the total improvement score. The same criteria were chosen for juvenile DM, with different improvement thresholds. Sensitivity and specificity in DM/PM patient cohorts were 85% and 92%, 90% and 96%, and 92% and 98% for minimal, moderate, and major improvement, respectively. Definitions were validated in the clinical trial analysis for differentiating the physician rating of improvement (P < 0.001). The response criteria for adult DM/PM consisted of the conjoint analysis model based on absolute percent change in 6 core set measures, with thresholds for minimal, moderate, and major improvement. © 2017, American College of Rheumatology.

European validation of The Comprehensive International Classification of Functioning, Disability and Health Core Set for Osteoarthritis from the perspective of patients with osteoarthritis of the knee or hip.

PubMed

Weigl, Martin; Wild, Heike

2017-09-15

To validate the International Classification of Functioning, Disability and Health Comprehensive Core Set for Osteoarthritis from the patient perspective in Europe. This multicenter cross-sectional study involved 375 patients with knee or hip osteoarthritis. Trained health professionals completed the Comprehensive Core Set, and patients completed the Short-Form 36 questionnaire. Content validity was evaluated by calculating prevalences of impairments in body function and structures, limitations in activities and participation and environmental factors, which were either barriers or facilitators. Convergent construct validity was evaluated by correlating the International Classification of Functioning, Disability and Health categories with the Short-Form 36 Physical Component Score and the SF-36 Mental Component Score in a subgroup of 259 patients. The prevalences of all body function, body structure and activities and participation categories were >40%, >32% and >20%, respectively, and all environmental factors were relevant for >16% of patients. Few categories showed relevant differences between knee and hip osteoarthritis. All body function categories and all but two activities and participation categories showed significant correlations with the Physical Component Score. Body functions from the ICF chapter Mental Functions showed higher correlations with the Mental Component Score than with the Physical Component Score. This study supports the validity of the International Classification of Functioning, Disability and Health Comprehensive Core Set for Osteoarthritis. Implications for Rehabilitation Comprehensive International Classification of Functioning, Disability and Health Core Sets were developed as practical tools for application in multidisciplinary assessments. The validity of the Comprehensive International Classification of Functioning, Disability and Health Core Set for Osteoarthritis in this study supports its application in European patients with osteoarthritis. The differences in results between this Europe validation study and a previous Singaporean validation study underscore the need to validate the International Classification of Functioning, Disability and Health Core Sets in different regions of the world.

Building a National Culture of Health

PubMed Central

Chandra, Anita; Acosta, Joie; Carman, Katherine Grace; Dubowitz, Tamara; Leviton, Laura; Martin, Laurie T.; Miller, Carolyn; Nelson, Christopher; Orleans, Tracy; Tait, Margaret; Trujillo, Matthew; Towe, Vivian; Yeung, Douglas; Plough, Alonzo L.

2017-01-01

Abstract Because health is a function of more than medical care, solutions to U.S. health problems must encompass more than reforms to health care systems. But those working to improve health, well-being, and equity still too often find themselves traveling on parallel paths that rarely intersect. In 2013, the Robert Wood Johnson Foundation (RWJF) embarked on a pioneering effort to advance a Culture of Health initiative. A Culture of Health places well-being at the center of every aspect of life, with the goal of enabling everyone in our diverse society to lead healthier lives, now and for generations to come. To put this vision into action, RWJF worked with RAND to develop an action framework that identifies how the nation will work toward achieving these outcomes. This article provides background on the development of this action framework. The Culture of Health action framework is designed around four action areas and one outcome area. Action areas are the core areas in which investment and activity are needed: (1) making health a shared value; (2) fostering cross-sector collaboration to improve well-being; (3) creating healthier, more equitable communities; and (4) strengthening integration of health services and systems. Each action area contains a set of drivers indicating where the United States needs to accelerate change and a set of measures illustrating places for progress. Within the primary Culture of Health outcome---improved population health, well-being, and equity---the authors identified three outcome areas: enhanced individual and community well-being, managed chronic disease and reduced toxic stress, and reduced health care costs. PMID:28845341

Exemplary Care and Learning Sites: A Model for Achieving Continual Improvement in Care and Learning in the Clinical Setting

PubMed Central

Ogrinc, Greg; Hoffman, Kimberly G.; Stevenson, Katherine M.; Shalaby, Marc; Beard, Albertine S.; Thörne, Karin E.; Coleman, Mary T.; Baum, Karyn D.

2016-01-01

Problem Current models of health care quality improvement do not explicitly describe the role of health professions education. The authors propose the Exemplary Care and Learning Site (ECLS) model as an approach to achieving continual improvement in care and learning in the clinical setting. Approach From 2008–2012, an iterative, interactive process was used to develop the ECLS model and its core elements—patients and families informing process changes; trainees engaging both in care and the improvement of care; leaders knowing, valuing, and practicing improvement; data transforming into useful information; and health professionals competently engaging both in care improvement and teaching about care improvement. In 2012–2013, a three-part feasibility test of the model, including a site self-assessment, an independent review of each site’s ratings, and implementation case stories, was conducted at six clinical teaching sites (in the United States and Sweden). Outcomes Site leaders reported the ECLS model provided a systematic approach toward improving patient (and population) outcomes, system performance, and professional development. Most sites found it challenging to incorporate the patients and families element. The trainee element was strong at four sites. The leadership and data elements were self-assessed as the most fully developed. The health professionals element exhibited the greatest variability across sites. Next Steps The next test of the model should be prospective, linked to clinical and educa tional outcomes, to evaluate whether it helps care delivery teams, educators, and patients and families take action to achieve better patient (and population) outcomes, system performance, and professional development. PMID:26760058

A model for enhancing Internet medical document retrieval with "medical core metadata".

PubMed

Malet, G; Munoz, F; Appleyard, R; Hersh, W

1999-01-01

Finding documents on the World Wide Web relevant to a specific medical information need can be difficult. The goal of this work is to define a set of document content description tags, or metadata encodings, that can be used to promote disciplined search access to Internet medical documents. The authors based their approach on a proposed metadata standard, the Dublin Core Metadata Element Set, which has recently been submitted to the Internet Engineering Task Force. Their model also incorporates the National Library of Medicine's Medical Subject Headings (MeSH) vocabulary and MEDLINE-type content descriptions. The model defines a medical core metadata set that can be used to describe the metadata for a wide variety of Internet documents. The authors propose that their medical core metadata set be used to assign metadata to medical documents to facilitate document retrieval by Internet search engines.

A Model for Enhancing Internet Medical Document Retrieval with “Medical Core Metadata”

PubMed Central

Malet, Gary; Munoz, Felix; Appleyard, Richard; Hersh, William

1999-01-01

Objective: Finding documents on the World Wide Web relevant to a specific medical information need can be difficult. The goal of this work is to define a set of document content description tags, or metadata encodings, that can be used to promote disciplined search access to Internet medical documents. Design: The authors based their approach on a proposed metadata standard, the Dublin Core Metadata Element Set, which has recently been submitted to the Internet Engineering Task Force. Their model also incorporates the National Library of Medicine's Medical Subject Headings (MeSH) vocabulary and Medline-type content descriptions. Results: The model defines a medical core metadata set that can be used to describe the metadata for a wide variety of Internet documents. Conclusions: The authors propose that their medical core metadata set be used to assign metadata to medical documents to facilitate document retrieval by Internet search engines. PMID:10094069

Clinical practice breastfeeding recommendations for primary care: applying a tri-core breastfeeding conceptual model.

PubMed

Busch, Deborah W; Logan, Kathleen; Wilkinson, Ashley

2014-01-01

Promotional practice efforts are needed in primary care to support and foster breastfeeding as the first and natural choice of nutrition for all infants regardless of race, ethnicity, educational, or income demographics in the United States. Societal awareness is increasing with regard to the significant protective qualities that human milk bestows upon public health. An estimated 75% of American mothers attempt to breastfeed, but according to the Centers for Disease Control and Prevention, just 13% are able to exclusively breastfeed by 6 months. Early identification of lactation issues is crucial to establishing and sustaining breastfeeding for the first 6 to 12 months of the child's life and beyond. We propose a set of primary care guidelines, applying a Tri-Core Model approach, to promote and foster breastfeeding efforts in the postpartum period. Breastfeeding promotion is a fundamental public health endeavor, and pediatric nurse practitioners and other advanced practice registered nurses (APRNs) are uniquely qualified to become specialists and experts in lactation care and management. Lactation support, which should be an integral facet of an APRN's practice and education, will aid in improving national breastfeeding rates and patient care outcomes. Application of the Tri-Core Model approach will help APRNs develop and implement evidence-based practice efforts that incorporate the mother-baby dyad and other multiprofessionals who are vested in successful breastfeeding outcomes. The goal of pediatric health care is provide safe and effective health care to all infants, children, and adolescents, and lactation care is an integral and crucial component of this effort. Copyright © 2014 National Association of Pediatric Nurse Practitioners. Published by Elsevier Inc. All rights reserved.

Development of an internationally agreed minimal dataset for juvenile dermatomyositis (JDM) for clinical and research use.

PubMed

McCann, Liza J; Kirkham, Jamie J; Wedderburn, Lucy R; Pilkington, Clarissa; Huber, Adam M; Ravelli, Angelo; Appelbe, Duncan; Williamson, Paula R; Beresford, Michael W

2015-06-12

Juvenile dermatomyositis (JDM) is a rare autoimmune inflammatory disorder associated with significant morbidity and mortality. International collaboration is necessary to better understand the pathogenesis of the disease, response to treatment and long-term outcome. To aid international collaboration, it is essential to have a core set of data that all researchers and clinicians collect in a standardised way for clinical purposes and for research. This should include demographic details, diagnostic data and measures of disease activity, investigations and treatment. Variables in existing clinical registries have been compared to produce a provisional data set for JDM. We now aim to develop this into a consensus-approved minimum core dataset, tested in a wider setting, with the objective of achieving international agreement. A two-stage bespoke Delphi-process will engage the opinion of a large number of key stakeholders through Email distribution via established international paediatric rheumatology and myositis organisations. This, together with a formalised patient/parent participation process will help inform a consensus meeting of international experts that will utilise a nominal group technique (NGT). The resulting proposed minimal dataset will be tested for feasibility within existing database infrastructures. The developed minimal dataset will be sent to all internationally representative collaborators for final comment. The participants of the expert consensus group will be asked to draw together these comments, ratify and 'sign off' the final minimal dataset. An internationally agreed minimal dataset has the potential to significantly enhance collaboration, allow effective communication between groups, provide a minimal standard of care and enable analysis of the largest possible number of JDM patients to provide a greater understanding of this disease. The final approved minimum core dataset could be rapidly incorporated into national and international collaborative efforts, including existing prospective databases, and be available for use in randomised controlled trials and for treatment/protocol comparisons in cohort studies.

34. DESPATCH CORE OVENS, GREY IRON FOUNDRY CORE ROOM, BAKES ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

34. DESPATCH CORE OVENS, GREY IRON FOUNDRY CORE ROOM, BAKES CORES THAT ARE NOT MADE ON HEATED OR COLD BOX CORE MACHINES, TO SET BINDING AGENTS MIXED WITH THE SAND CREATING CORES HARD ENOUGH TO WITHSTAND THE FLOW OF MOLTEN IRON INSIDE A MOLD. - Stockham Pipe & Fittings Company, Grey Iron Foundry, 4000 Tenth Avenue North, Birmingham, Jefferson County, AL

Using Likert-type and ipsative/forced choice items in sequence to generate a preference.

PubMed

Ried, L Douglas

2014-01-01

Collaboration and implementation of a minimum, standardized set of core global educational and professional competencies seems appropriate given the expanding international evolution of pharmacy practice. However, winnowing down hundreds of competencies from a plethora of local, national and international competency frameworks to select the most highly preferred to be included in the core set is a daunting task. The objective of this paper is to describe a combination of strategies used to ascertain the most highly preferred items among a large number of disparate items. In this case, the items were >100 educational and professional competencies that might be incorporated as the core components of new and existing competency frameworks. Panelists (n = 30) from the European Union (EU) and United States (USA) were chosen to reflect a variety of practice settings. Each panelist completed two electronic surveys. The first survey presented competencies in a Likert-type format and the second survey presented many of the same competencies in an ipsative/forced choice format. Item mean scores were calculated for each competency, the competencies were ranked, and non-parametric statistical tests were used to ascertain the consistency in the rankings achieved by the two strategies. This exploratory study presented over 100 competencies to the panelists in the beginning. The two methods provided similar results, as indicated by the significant correlation between the rankings (Spearman's rho = 0.30, P < 0.09). A two-step strategy using Likert-type and ipsative/forced choice formats in sequence, appears to be useful in a situation where a clear preference is required from among a large number of choices. The ipsative/forced choice format resulted in some differences in the competency preferences because the panelists could not rate them equally by design. While this strategy was used for the selection of professional educational competencies in this exploratory study, it is applicable in other situations where a smaller set of highly preferred items might be selected from a large list of choices in other areas of inquiry (e.g., patient reported outcomes). Copyright © 2014 Elsevier Inc. All rights reserved.

Surveillance of working conditions and the work environment: development of a national hazard surveillance tool in New Zealand.

PubMed

Lilley, Rebbecca; Feyer, Anne-Marie; Firth, Hilda; Cunningham, Chris; Paul, Charlotte

2010-02-01

Changes to work and the impact of these changes on worker health and safety have been significant. A core surveillance data set is needed to understand the impact of working conditions and work environments. Yet, there is little harmony amongst international surveys and a critical lack of guidance identifying the best directions for surveillance efforts. This paper describes the establishment of an instrument suitable for use as a hazard surveillance tool for New Zealand workers. An iterative process of critical review was undertaken to create a dimensional framework and select specific measures from existing instruments. Pilot testing to ascertain participant acceptability of the questions was undertaken. The final questionnaire includes measures of socio-demographic characteristics, occupational history, work organisation, physicochemical, ergonomic and psychosocial hazards. Outcome measures were also included. A robust New Zealand hazard surveillance questionnaire comprehensively covering the key measures of work organisation and work environments that impact upon worker health and safety outcomes was developed. Recommended measures of work organisation, work environment and health outcomes that should be captured in work environment surveillance are made.

The development of learning materials based on core model to improve students’ learning outcomes in topic of Chemical Bonding

NASA Astrophysics Data System (ADS)

Avianti, R.; Suyatno; Sugiarto, B.

2018-04-01

This study aims to create an appropriate learning material based on CORE (Connecting, Organizing, Reflecting, Extending) model to improve students’ learning achievement in Chemical Bonding Topic. This study used 4-D models as research design and one group pretest-posttest as design of the material treatment. The subject of the study was teaching materials based on CORE model, conducted on 30 students of Science class grade 10. The collecting data process involved some techniques such as validation, observation, test, and questionnaire. The findings were that: (1) all the contents were valid, (2) the practicality and the effectiveness of all the contents were good. The conclusion of this research was that the CORE model is appropriate to improve students’ learning outcomes for studying Chemical Bonding.

What Factors Influence States' Capacity to Report Children's Health Care Quality Measures? A Multiple-Case Study.

PubMed

Christensen, Anna L; Petersen, Dana M; Burton, Rachel A; Forsberg, Vanessa C; Devers, Kelly J

2017-01-01

Objectives The objective of this study was to describe factors that influence the ability of state Medicaid agencies to report the Centers for Medicare & Medicaid Services' (CMS) core set of children's health care quality measures (Child Core Set). Methods We conducted a multiple-case study of four high-performing states participating in the Children's Health Insurance Program Reauthorization Act (CHIPRA) Quality Demonstration Grant Program: Illinois, Maine, Pennsylvania, and Oregon. Cases were purposively selected for their diverse measurement approaches and used data from 2010 to 2015, including 154 interviews, semiannual grant progress reports, and annual public reports on Child Core Set measures. We followed Yin's multiple-case study methodology to describe how and why each state increased the number of measures reported to CMS. Results All four states increased the number of Child Core Set measures reported to CMS during the grant period. Each took a different approach to reporting, depending on the available technical, organizational, and behavioral inputs in the state. Reporting capacity was influenced by a state's Medicaid data availability, ability to link to other state data systems, past experience with quality measurement, staff time and technical expertise, and demand for the measures. These factors were enhanced by CHIPRA Quality Demonstration grant funding and other federal capacity building activities, as hypothesized in our conceptual framework. These and other states have made progress reporting the Child Core Set since 2010. Conclusion With financial support and investment in state data systems and organizational factors, states can overcome challenges to reporting most of the Child Core Set measures.

Treatment Success of Hip and Core or Knee Strengthening for Patellofemoral Pain: Development of Clinical Prediction Rules.

PubMed

Earl-Boehm, Jennifer E; Bolgla, Lori A; Emory, Carolyn; Hamstra-Wright, Karrie L; Tarima, Sergey; Ferber, Reed

2018-06-12

  Patellofemoral pain (PFP) is a common injury that interferes with quality of life and physical activity. Clinical subgroups of patients may exist, one of which is proximal muscle dysfunction.   To develop clinical prediction rules that predict a positive outcome after either a hip and core- or knee-focused strengthening program for individuals with PFP.   Secondary analysis of data from a randomized control trial.   Four university laboratories.   A total of 199 participants with PFP.   Participants were randomly allocated to either a hip and core-focused (n = 111) or knee-focused (n = 88) rehabilitation group for a 6-week program.   Demographics, self-reported knee pain (visual analog scale) and function (Anterior Knee Pain Scale), hip strength, abdominal muscle endurance, and hip range of motion were evaluated at baseline. Treatment success was defined as a decrease in visual analog scale score by ≥2 cm or an increase in the Anterior Knee Pain Scale score by ≥8 points or both. Bivariate relationships between the outcome (treatment success) and the predictor variables were explored, followed by a forward stepwise logistic regression to predict a successful outcome.   Patients with more pain, better function, greater lateral core endurance, and less anterior core endurance were more likely to have a successful outcome after hip and core strengthening (88% sensitivity and 54% specificity). Patients with lower weight, weaker hip internal rotation, stronger hip extension, and greater trunk-extension endurance were more likely to have success after knee strengthening (82% sensitivity and 58% specificity).   The patients with PFP who have more baseline pain and yet maintain a high level of function may experience additional benefit from hip and core strengthening. The clinical prediction rules from this study remain in the developmental phase and should be applied with caution until externally validated.

Outcome Measurement in the Treatment of Spasmodic Dysphonia: A Systematic Review of the Literature.

PubMed

Rumbach, Anna; Aiken, Patrick; Novakovic, Daniel

2018-04-11

The aim of this review was to systematically identify all available studies reporting outcomes measures to assess treatment outcomes for people with spasmodic dysphonia (SD). Full-text journal articles were identified through searches of PubMed, Embase, CINAHL, and Cochrane databases and hand searching of journals. A total of 4,714 articles were retrieved from searching databases; 1,165 were duplicates. Titles and abstracts of 3,549 were screened, with 171 being selected for full-text review. During full-text review, 101 articles were deemed suitable for inclusion. An additional 24 articles were identified as suitable for inclusion through a hand search of reference lists. Data were extracted from 125 studies. A total of 220 outcome measures were identified. Considered in reference to the World Health Organization International Classification of Functioning, Disability and Health (ICF), the majority of outcomes were measured at a Body Function level (n = 212, 96%). Outcomes that explored communication and participation in everyday life and attitudes toward communication (ie, activity and participation domains) were infrequent (n = 8; 4%). Quality of life, a construct not measured within the ICF, was also captured by four outcome measures. No instruments evaluating communication partners' perspectives or burden/disability were identified. The outcome measures used in SD treatment studies are many and varied. The outcome measures identified predominately measure constructs within the Body Functions component of the ICF. In order to facilitate data synthesis across trials, the development of a core outcome set is recommended. Crown Copyright © 2018. Published by Elsevier Inc. All rights reserved.

Postnatal hypothermia and cold stress among newborn infants in Nepal monitored by continuous ambulatory recording.

PubMed

Ellis, M; Manandhar, N; Shakya, U; Manandhar, D S; Fawdry, A; Costello, A M

1996-07-01

To describe the pattern of hypothermia and cold stress after delivery among a normal neonatal population in Nepal; to provide practical advice for improving thermal care in a resource limited maternity hospital. The principal government funded maternity hospital in Kathmandu, Nepal, with an annual delivery rate of 15,000 (constituting 40% of all Kathmandu Valley deliveries), severe resource limitations (annual budget Pounds 250,000), and a cold winter climate provided the setting. Thirty five healthy term neonates not requiring special care were enrolled for study within 90 minutes of birth. Continuous ambulatory temperature monitoring, using microthermistor skin probes for forehead and axilla, a flexible rectal probe, and a black ball probe placed next to the infant for ambient temperature, was carried out. All probes were connected to a compact battery powered Squirrel Memory Logger, giving a temperature reading to 0.2 degree C at five minute intervals for 24 hours. Severity and duration of hypothermia, using cutoff values of core temperature less than 36 degrees C, 34 degrees C, and 32 degrees C; and cold stress, using cutoff values of skin-core (forehead-axilla) temperature difference greater than 3 degrees C and 4 degrees C were the main outcome measures. Twenty four hour mean ambient temperatures were generally lower than the WHO recommended level of 25 degrees C (median 22.3 degrees C, range 15.1-27.5 degrees C). Postnatal hypothermia was prolonged, with axillary core temperatures only reaching 36 degrees C after a mean of 6.4 hours (range 0-21.1; SD 4.6). There was persistent and increasing cold stress over the first 24 hours with the core-skin (axillary-forehead) temperature gap exceeding 3 degrees C for more than half of the first 24 hours. Continuous ambulatory recording identifies weak links in the "warm chain" for neonates. The severity and duration of thermal problems was greater than expected even in a hospital setting where some of the WHO recommendations had already been implemented.

MRI Evaluation of Post Core Decompression Changes in Avascular Necrosis of Hip.

PubMed

Nori, Madhavi; Marupaka, Sravan Kumar; Alluri, Swathi; Md, Naseeruddin; Irfan, Kazi Amir; Jampala, Venkateshwarlu; Apsingi, Sunil; Eachempati, Krishna Kiran

2015-12-01

Avascular necrosis of hip typically presents in young patients. Core decompression in precollapse stage provides pain relief and preservation of femoral head. The results of core decompression vary considerably despite early diagnosis. The role of MRI in monitoring patients post surgically has not been clearly defined. To study pre and post core decompression MRI changes in avascular necrosis of hip. This is a contiguous observational cohort of 40 hips treated by core decompression for precollapse avascular necrosis of femoral head, who had a baseline MRI performed before surgery. Core decompression of the femoral head was performed within 4 weeks. Follow up radiograph and MRI scans were done at six months. Harris hip score preoperatively, 1 month and 6 months after the surgery was noted. Success in this study was defined as postoperative increase in Harris hip score (HHS) by 20 points and no additional femoral collapse. End point of clinical adverse outcome as defined by fall in Harris hip score was conversion or intention to convert to total hip replacement (THR). MRI parameters in the follow up scan were compared to the preoperative MRI. Effect of core decompression on bone marrow oedema and femoral head collapse was noted. Results were analysed using SPSS software version. Harris hip score improved from 57 to 80 in all patients initially. Six hips had a fall in Harris hip score to mean value of 34.1 during follow up (9 to 12 months) and underwent total hip replacement. MRI predictors of positive outcome are lesions with grade A extent, Grade A & B location. Bone marrow oedema with lesions less than 50% involvement, medial and central location. Careful selection of patients by MR criteria for core decompression provides satisfactory outcome in precollapse stage of avascular necrosis of hip.

Salutogenically focused outcomes in systematic reviews of intrapartum interventions: a systematic review of systematic reviews.

PubMed

Smith, Valerie; Daly, Deirdre; Lundgren, Ingela; Eri, Tine; Benstoem, Carina; Devane, Declan

2014-04-01

research on intrapartum interventions in maternity care has focused traditionally on the identification of risk factors' and on the reduction of adverse outcomes with less attention given to the measurement of factors that contribute to well-being and positive health outcomes. We conducted a systematic review of reviews to determine the type and number of salutogenically-focused reported outcomes in current maternity care intrapartum intervention-based research. For the conduct of this review, we interpreted salutogenic outcomes as those relating to optimum and/or positive maternal and neonatal health and well-being. to identify salutogenically-focused outcomes reported in systematic reviews of randomised trials of intrapartum interventions. we searched Issue 9 (September) 2011 of the Cochrane Database of Systematic Reviews for all reviews of intrapartum interventions published by the Cochrane Pregnancy and Childbirth Group using the group filter "hm-preg". Systematic reviews of randomised trials of intrapartum interventions were eligible for inclusion. We excluded protocols for systematic reviews and systematic reviews that had been withdrawn. Outcome data were extracted independently from each included review by at least two review authors. Unique lists of salutogenically and non-salutogenically focused outcomes were established. 16 salutogenically-focused outcome categories were identified in 102 included reviews. Maternal satisfaction and breast feeding were reported most frequently. 49 non-salutogenically-focused outcome categories were identified in the 102 included reviews. Measures of neonatal morbidity were reported most frequently. there is an absence of salutogenically-focused outcomes reported in intrapartum intervention-based research. We recommend the development of a core outcome data set of salutogenically-focused outcomes for intrapartum research. © 2013 Published by Elsevier Ltd.

Examining the relationships between span of control and manager job and unit performance outcomes.

PubMed

Wong, Carol A; Elliott-Miller, Pat; Laschinger, Heather; Cuddihy, Michael; Meyer, Raquel M; Keatings, Margaret; Burnett, Camille; Szudy, Natalie

2015-03-01

Our aim was to examine the combination of frontline manager (FLM) personal characteristics and span of control (SOC) on their job and unit performance outcomes. Healthcare downsizing and reform have contributed to larger spans for FLMs in Canadian hospitals and increased concerns about manager workload. Despite a heightened awareness of SOC issues among decision makers, there is limited empirical evidence related to the effects of SOC on outcomes. A non-experimental predictive survey design was used to examine FLM SOC in 14 Canadian academic hospitals. Managers (n = 121) completed an online survey of work characteristics and The Ottawa Hospital (TOH) SOC tool. Unit turnover data were collected from organisational databases. The combination of SOC and core self-evaluation significantly predicted role overload, work control and job satisfaction, but only SOC predicted unit adverse outcomes and neither significantly predicted unit turnover. The findings contribute to an understanding of connections between the combination of SOC and core self-evaluation and manager job and unit performance outcomes. Organisational strategies to create manageable FLM SOC are essential to ensure exemplary job and unit outcomes. Core self-evaluation is a personality characteristic that may enhance manager performance in the face of high spans of control. © 2013 John Wiley & Sons Ltd.

Does core stability exercise improve lumbopelvic stability (through endurance tests) more than general exercise in chronic low back pain? A quasi-randomized controlled trial.

PubMed

Shamsi, Mohammad Bagher; Rezaei, Mandana; Zamanlou, Mehdi; Sadeghi, Mehdi; Pourahmadi, Mohammad Reza

2016-01-01

The aim was to compare core stability and general exercises (GEs) in chronic low back pain (LBP) patients based on lumbopelvic stability (LPS) assessment through three endurance core stability tests. There is a controversy about preference of core stability exercise (CSE) over other types of exercise for chronic LBP. Studies which have compared these exercises used other outcomes than those related to LPS. As it is claimed that CSE enhances back stability, endurance tests for LPS were used. A 16-session CSE program and a GE program with the same duration were conducted for two groups of participants. Frequency of interventions for both groups was three times a week. Forty-three people (aged 18-60 years) with chronic non-specific LBP were alternately allocated to core stability (n = 22) or GE group (n = 21) when admitted. The primary outcomes were three endurance core stability tests including: (1) trunk flexor; (2) trunk extensor; and (3) side bridge tests. Secondary outcomes were disability and pain. Measurements were taken at baseline and the end of the intervention. After the intervention, test times increased and disability and pain decreased within groups. There was no significant difference between two groups in increasing test times (p = 0.23 to p = 0.36) or decreasing disability (p = 0.16) and pain (p = 0.73). CSE is not more effective than GE for improving endurance core stability tests and reducing disability and pain in chronic non-specific LBP patients.

Real-world daptomycin use across wide geographical regions: results from a pooled analysis of CORE and EU-CORE.

PubMed

Seaton, R Andrew; Gonzalez-Ruiz, Armando; Cleveland, Kerry O; Couch, Kimberly A; Pathan, Rashidkhan; Hamed, Kamal

2016-03-15

Pooled data from two large registries, Cubicin(®) Outcomes Registry and Experience (CORE; USA) and European Cubicin(®) Outcomes Registry and Experience (EU-CORE; Europe, Latin America, and Asia), were analyzed to determine the characteristics and clinical outcomes of daptomycin therapy in patients with Gram-positive infections across wide geographical regions. Patients receiving at least one dose of daptomycin between 2004 and 2012 for the treatment of Gram-positive infections were included. Clinical success was defined as an outcome of 'cured' or 'improved'. Post-treatment follow-up data were collected for a subset of patients (CORE: osteomyelitis and orthopedic foreign body device infection; EU-CORE: endocarditis, intracardiac/intravascular device infection, osteomyelitis, and orthopedic device infection). Safety was assessed for up to 30 days after daptomycin treatment. In 11,557 patients (CORE, 5482; EU-CORE, 6075) treated with daptomycin (median age, 62 [range, 1-103] years), the most frequent underlying conditions were cardiovascular disease (54.7 %) and diabetes mellitus (28.0 %). The most commonly treated primary infections were complicated skin and soft tissue infection (cSSTI; 31.2 %) and bacteremia (21.8 %). The overall clinical success rate was 77.2 % (uncomplicated SSTI, 88.3 %; cSSTI, 81.0 %; osteomyelitis, 77.7 %; foreign body/prosthetic infection (FBPI), 75.9 %; endocarditis, 75.4 %; and bacteremia, 69.5 %). The clinical success rate was 79.1 % in patients with Staphylococcus aureus infections (MRSA, 78.1 %). An increasing trend of high-dose daptomycin (>6 mg/kg/day) prescribing pattern was observed over time. Clinical success rates were higher with high-dose daptomycin treatment for endocarditis and FBPI. Adverse events (AEs) and serious AEs possibly related to daptomycin therapy were reported in 628 (5.4 %) and 133 (1.2 %) patients, respectively. The real-world data showed that daptomycin was effective and safe in the treatment of various Gram-positive infections, including those caused by resistant pathogens, across wide geographical regions.

Interpretation of the results of the CORA-33 dry core BWR test

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

Ott, L.J.; Hagen, S.

All BWR degraded core experiments performed prior to CORA-33 were conducted under ``wet`` core degradation conditions for which water remains within the core and continuous steaming feeds metal/steam oxidation reactions on the in-core metallic surfaces. However, one dominant set of accident scenarios would occur with reduced metal oxidation under ``dry`` core degradation conditions and, prior to CORA-33, this set had been neglected experimentally. The CORA-33 experiment was designed specifically to address this dominant set of BWR ``dry`` core severe accident scenarios and to partially resolve phenomenological uncertainties concerning the behavior of relocating metallic melts draining into the lower regions ofmore » a ``dry`` BWR core. CORA-33 was conducted on October 1, 1992, in the CORA tests facility at KfK. Review of the CORA-33 data indicates that the test objectives were achieved; that is, core degradation occurred at a core heatup rate and a test section axial temperature profile that are prototypic of full-core nuclear power plant (NPP) simulations at ``dry`` core conditions. Simulations of the CORA-33 test at ORNL have required modification of existing control blade/canister materials interaction models to include the eutectic melting of the stainless steel/Zircaloy interaction products and the heat of mixing of stainless steel and Zircaloy. The timing and location of canister failure and melt intrusion into the fuel assembly appear to be adequately simulated by the ORNL models. This paper will present the results of the posttest analyses carried out at ORNL based upon the experimental data and the posttest examination of the test bundle at KfK. The implications of these results with respect to degraded core modeling and the associated safety issues are also discussed.« less

GrowYourIC: A Step Toward a Coherent Model of the Earth's Inner Core Seismic Structure

NASA Astrophysics Data System (ADS)

Lasbleis, Marine; Waszek, Lauren; Day, Elizabeth A.

2017-11-01

A complex inner core structure has been well established from seismic studies, showing radial and lateral heterogeneities at various length scales. Yet no geodynamic model is able to explain all the features observed. One of the main limits for this is the lack of tools to compare seismic observations and numerical models successfully. We use here a new Python tool called GrowYourIC to compare models of inner core structure. We calculate properties of geodynamic models of the inner core along seismic raypaths, for random or user-specified data sets. We test kinematic models which simulate fast lateral translation, superrotation, and differential growth. We explore first the influence on a real inner core data set, which has a sparse coverage of the inner core boundary. Such a data set is however able to successfully constrain the hemispherical boundaries due to a good sampling of latitudes. Combining translation and rotation could explain some of the features of the boundaries separating the inner core hemispheres. The depth shift of the boundaries, observed by some authors, seems unlikely to be modeled by a fast translation but could be produced by slow translation associated with superrotation.

Air ingression calculations for selected plant transients using MELCOR

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

Kmetyk, L.N.

1994-01-01

Two sets of MELCOR calculations have been completed studying the effects of air ingression on the consequences of various severe accident scenarios. One set of calculations analyzed a station blackout with surge line failure prior to vessel breach, starting from nominal operating conditions; the other set of calculations analyzed a station blackout occurring during shutdown (refueling) conditions. Both sets of analyses were for the Surry plant, a three-loop Westinghouse PWR. For both accident scenarios, a basecase calculation was done, and then repeated with air ingression from containment into the core region following core degradation and vessel failure. In addition tomore » the two sets of analyses done for this program, a similar air-ingression sensitivity study was done as part of a low-power/shutdown PRA, with results summarized here; that PRA study also analyzed a station blackout occurring during shutdown (refueling) conditions, but for the Grand Gulf plant, a BWR/6 with Mark III containment. These studies help quantify the amount of air that would have to enter the core region to have a significant impact on the severe accident scenario, and demonstrate that one effect, of air ingression is substantial enhancement of ruthenium release. These calculations also show that, while the core clad temperatures rise more quickly due to oxidation with air rather than steam, the core also degrades and relocates more quickly, so that no sustained, enhanced core heatup is predicted to occur with air ingression.« less

Patient Core Data Set. Standard for a longitudinal health/medical record.

PubMed

Renner, A L; Swart, J C

1997-01-01

Blue Chip Computers Company, in collaboration with Wright State University-Miami Valley College of Nursing and Health, with support from the Agency for Health Care Policy and Research, Public Health Service, completed Small Business innovative Research research to design a comprehensive integrated Patient information System. The Wright State University consultants undertook the development of a Patient Core Data Set (PCDS) in response to the lack of uniform standards of minimum data sets, and lack of standards in data transfer for continuity of care. The purpose of the Patient Core Data Set is to develop a longitudinal patient health record and medical history using a common set of standard data elements with uniform definitions and coding consistent with Health Level 7 (HL7) protocol and the American Society for Testing and Materials (ASTM) standards. The PCDS, intended for transfer across all patient-care settings, is essential information for clinicians, administrators, researchers, and health policy makers.

Development of a core set of quality indicators for paediatric primary care practices in Europe, COSI-PPC-EU.

PubMed

Ewald, Dominik A; Huss, Gottfried; Auras, Silke; Caceres, Juan Ruiz-Canela; Hadjipanayis, Adamos; Geraedts, Max

2018-06-01

Paediatric ambulatory healthcare systems in Europe are, because of historical reasons, diverse and show strikingly different outcomes. All across Europe, the benchmarking of structures, processes and outcomes could reveal opportunities for improving Paediatric Primary Care (PPC). The aim of this study was to develop a set of Quality Indicators (QIs) to assess and monitor PPC in Europe. In a three-step process, we used the available external evidence and European expert consensus in a modified RAND/UCLA Appropriateness Method (RAM) to develop an indicator set. (1) A broad literature and online research of published QI and guidelines yielded an inventory of 1516 QI. (2) A collaborative panel of paediatric senior experts from the European Academy of Paediatrics (EAP) and the European Confederation of Primary Care Paediatricians (ECPCP) from 15 European countries participated in a first consensus process to reduce the initial indicator inventory by eliminating not PPC-focused indicators and duplicates. (3) In a second consensus process, the panel rated the QI regarding validity and feasibility. The final QI set "COSI-PPC-EU" consists of 42 indicators in five categories of PPC: (A) health promotion/prevention/screening (13 QI), (B) acute care (9 QI), (C) chronic care (8 QI), (D) practice management (3 QI) and (E) patient safety (9 QI). COSI-PPC-EU represents a consented set of a limited number of valid quality indicators for the application in paediatric primary care in different healthcare systems throughout Europe. What is Known: • Paediatric ambulatory healthcare systems in Europe are diverse and show strikingly different outcomes. • There are known gaps in quality performance measures of paediatric primary care in Europe. Pre-existing sets of quality indicators are predominantly limited to national populations, specific diseases and hospital care. What is New: • A set of 42 quality indicators for primary paediatric care in Europe was developed in a multi-country collaborative effort. The method combined a systematic literature review and a consensus process among European paediatric experts. • The quality indicator set can facilitate quality improvement of PPC. After studying the feasibility, providers can use COSI-PPC-EU to monitor, compare and improve performance of practices, regions and countries.

75 FR 52596 - Financial Education Core Competencies; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-26

... DEPARTMENT OF THE TREASURY Financial Education Core Competencies; Comment Request AGENCY..., in its capacity as Chairperson of the Financial Literacy and Education Commission (``Commission''), invites the public to comment on a proposed set of financial education core competencies (``Core...

Education Business Plan 2008-11: Ministry Business Plan

ERIC Educational Resources Information Center

Alberta Education, 2008

2008-01-01

The Ministry of Education has identified one core business that is an ongoing key responsibility. It is called "Core Business One: Lead and Support the Education System So That All Students Are Successful at Learning." The core business includes three goals with specific outcomes that describe the end results the Ministry wants to…

Training in Vocational Assessment: Preparing Rehabilitation Counselors and Meeting the Requirements of the CORE Standards

ERIC Educational Resources Information Center

Tansey, Timothy N.

2008-01-01

Assessment represents a foundational component of rehabilitation counseling services. The revised Council on Rehabilitation Education (CORE) standards implemented in 2004 resulted in the redesign of the knowledge and outcomes under the Assessment standard. The author reviews the current CORE standard for training in assessment within the context…

Core Intervention Components: Identifying and Operationalizing What Makes Programs Work. ASPE Research Brief

ERIC Educational Resources Information Center

Blase, Karen; Fixsen, Dean

2013-01-01

This brief is part of a series that explores key implementation considerations. It focuses on the importance of identifying, operationalizing, and implementing the "core components" of evidence-based and evidence-informed interventions that likely are critical to producing positive outcomes. The brief offers a definition of "core components",…

Sticking with it: Psychotherapy outcomes for adults with autism spectrum disorder in a university counseling center setting.

PubMed

Anderberg, Emily; Cox, Jonathan C; Neeley Tass, E Shannon; Erekson, David M; Gabrielsen, Terisa P; Warren, Jared S; Cline, Jared; Petersen, Devin; South, Mikle

2017-12-01

Young adults with autism spectrum disorders (ASD) experience high rates of comorbid mental health concerns in addition to distress arising from the core symptoms of autism. Many adults with ASD seek psychological treatment in outpatient facilities in their communities that are not specifically geared toward individuals with ASD. However, few studies have looked at the effectiveness of standard psychotherapeutic care in adults with ASD. This study aimed to discover how individuals with ASD fare in psychotherapy within a college counseling setting, compared to their neurotypical peers. Clients with ASD (n = 76) or possible ASD (n = 91) were retrospectively identified from counseling center case notes. Data from the Outcome Questionnaire-45 (OQ) were retrieved for each therapy session as a measure of client distress. Clients with ASD showed no difference in level of distress at intake compared to their neurotypical peers (n = 21,546), and improved about the same amount from pre- to post-treatment. However, students with ASD stayed in treatment for significantly more sessions than neurotypical clients, and took significantly longer to achieve maximum improvement on OQ reports. Results are discussed with implications for university and other community based treatment settings. Autism Res 2017, 10: 2048-2055. © 2017 International Society for Autism Research, Wiley Periodicals, Inc. This study aimed to discover how individuals with autism spectrum disorders (ASD) fare in psychotherapy within a university counseling setting, compared to their neurotypical peers. Clients with ASD showed no difference in level of distress at intake compared to their neurotypical peers, and improved about the same amount from pre- to post-treatment. However, students with ASD stayed in treatment for significantly more sessions than neurotypical clients, and took significantly longer to achieve maximum improvement on Outcome Questionnaire-45 reports. © 2017 International Society for Autism Research, Wiley Periodicals, Inc.

Core Today! Rationale and Implications. Revised Edition.

ERIC Educational Resources Information Center

Vars, Gordon, Ed.; Larson, Craig, Ed.

This pamphlet is designed to help educators apply the core concept to current problems and situations in educational settings. The preface establishes the position of the National Association for Core Curriculum. A definition of the core curriculum concept is stated in the introduction. Ten assumptions and beliefs on which the core concept is…

The hidden competencies of healthcare: why self-esteem, accountability, and professionalism may affect hospital customer satisfaction scores.

PubMed

Decker, P J

1999-01-01

Data from 103 for-profit, nonprofit, and government-owned hospitals, spread across about half of the United States clearly show that there are common elements and several core competencies in all hospitals, some probably driven by JCAHO accreditation standards, but others coming from universal experience stemming from the changes in healthcare. The common competencies that are not, in my opinion, driven directly by the JCAHO standards include professionalism, accountability, self-esteem, customer service/focus, communication, information management/using data in decision making, and teamwork. There are several possible connections among the core competencies that suggest that the effects of accountability and possibly self-esteem on such outcomes as patient satisfaction and quality of care should be the subject of more research in healthcare settings. There are, however, several possible interventions to increase the core competency base of any hospital, which can be applied without this research. Executives and managers who attempt to measure and change these common competencies through selection, assessment, organizational system change, or reward and compensation systems will change the competence base of their workforce in critical areas needed in the future healthcare economy. Using a competence model incorporating these competencies may change the culture of the organization toward that which will be needed for survival in the twenty-first century.

Core subjects at the end of primary school: identifying and explaining relative strengths of children with specific language impairment (SLI)

PubMed Central

Durkin, Kevin; Mok, Pearl L H; Conti-Ramsden, Gina

2015-01-01

Background In general, children with specific language impairment (SLI) tend to fall behind their typically developing (TD) peers in educational attainment. Less is known about how children with SLI fare in particular areas of the curriculum and what predicts their levels of performance. Aims To compare the distributions of performance of children with SLI in three core school subjects (English, Mathematics and Science); to test the possibility that performance would vary across the core subjects; and to examine the extent to which language impairment predicts performance. Methods & Procedures This study was conducted in England and reports historical data on educational attainments. Teacher assessment and test scores of 176 eleven-year-old children with SLI were examined in the three core subjects and compared with known national norms. Possible predictors of performance were measured, including language ability at ages 7 and 11, educational placement type, and performance IQ. Outcomes & Results Children with SLI, compared with national norms, were found to be at a disadvantage in core school subjects. Nevertheless, some children attained the levels expected of TD peers. Performance was poorest in English; relative strengths were indicated in Science and, to a lesser extent, in Mathematics. Language skills were significant predictors of performance in all three core subjects. PIQ was the strongest predictor for Mathematics. For Science, both early language skills at 7 years and PIQ made significant contributions. Conclusions & Implications Language impacts on the school performance of children with SLI, but differentially across subjects. English for these children is the most challenging of the core subjects, reflecting the high levels of language demand it incurs. Science is an area of relative strength and mathematics appears to be intermediate, arguably because some tasks in these subjects can be performed with less reliance on verbal processing. Many children with SLI do have the potential to reach or exceed educational targets that are set at national levels for TD children. PMID:25469890

Effect of Core Stability Training on Trunk Function, Standing Balance, and Mobility in Stroke Patients.

PubMed

Haruyama, Koshiro; Kawakami, Michiyuki; Otsuka, Tomoyoshi

2017-03-01

Trunk function is important for standing balance, mobility, and functional outcome after stroke, but few studies have evaluated the effects of exercises aimed at improving core stability in stroke patients. To investigate the effectiveness of core stability training on trunk function, standing balance, and mobility in stroke patients. An assessor-blinded, randomized controlled trial was undertaken in a stroke rehabilitation ward, with 32 participants randomly assigned to an experimental group or a control group (n = 16 each). The experimental group received 400 minutes of core stability training in place of conventional programs within total training time, while the control group received only conventional programs. Primary outcome measures were evaluated using the Trunk Impairment Scale (TIS), which reflects trunk function. Secondary outcome measures were evaluated by pelvic tilt active range of motion in the sagittal plane, the Balance Evaluation Systems Test-brief version (Brief-BESTest), Functional Reach test, Timed Up-and-Go test (TUG), and Functional Ambulation Categories (FAC). A general linear repeated-measures model was used to analyze the results. A treatment effect was found for the experimental group on the dynamic balance subscale and total score of the TIS ( P = .002 and P < .001, respectively), pelvic tilt active range of motion ( P < .001), Brief-BESTest ( P < .001), TUG ( P = .008), and FAC ( P = .022). Core stability training has beneficial effects on trunk function, standing balance, and mobility in stroke patients. Our findings might provide support for introducing core stability training in stroke rehabilitation.

Development and Psychometric Properties of a Tuberculosis-Specific Multidimensional Health-Related Quality-of-Life Measure for Patients with Pulmonary Tuberculosis.

PubMed

Abdulelah, Juman; Sulaiman, Syed Azhar Syed; Hassali, Mohamed A; Blebil, Ali Q; Awaisu, Ahmed; Bredle, Jason M

2015-05-01

Various generic instruments exist to assess health-related quality of life (HRQOL) in patients with tuberculosis (TB), but a psychometrically sound disease-specific instrument is lacking. The present study aimed to develop and psychometrically validate a multidimensional TB-specific HRQOL instrument relevant to the value of patients with pulmonary TB in Iraq with an eye toward cross-cultural application. The core general HRQOL questionnaire is composed of the Functional Assessment of Cancer Therapy-General items. A modular approach was followed for the development of the Functional Assessment of Chronic Illness Therapy-Tuberculosis (FACIT-TB) questionnaire in which a set of items assessing quality-of-life (QOL) issues not sufficiently covered by the core Functional Assessment of Cancer Therapy-General items, but considered to be relevant to the target population, was added. Moreover, principal-component analysis was used to determine the new subscale structure of the questionnaire. In addition to the 27 items of the core questionnaire, a set of 20 items referring to disease symptoms related to the site of infection, adverse effects, and additional QOL dimensions such as fatigue, social stigma, and economic burden of the illness was included. Factor analysis demonstrated that the FACIT-TB construct comprised five domains. A rigorous method was applied in the development of the FACIT-TB measure to fully understand the impact of TB on patients' QOL. The instrument is psychometrically sound and portrays multiple important dimensions of HRQOL. FACIT-TB is relatively brief, is easy to administer and score, and is appropriate for use in clinical trials and practice. Copyright © 2015 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Transitions, Risks, and Actions in Coronary Events--Center for Outcomes Research and Education (TRACE-CORE): design and rationale.

PubMed

Waring, Molly E; McManus, Richard H; Saczynski, Jane S; Anatchkova, Milena D; McManus, David D; Devereaux, Randolph S; Goldberg, Robert J; Allison, Jeroan J; Kiefe, Catarina I

2012-09-01

Cardiovascular disease continues to cause significant morbidity, mortality, and impaired quality of life, with unrealized health gains from the underuse of available evidence. The Transitions, Risks, and Actions in Coronary Events Center for Outcomes Research and Education (TRACE-CORE) aims to advance the science of acute coronary syndromes by examining the determinants and outcomes of the quality of transition from hospital to community and by quantifying the impact of potentially modifiable characteristics associated with decreased quality of life, rehospitalization, and mortality. TRACE-CORE comprises a longitudinal multiracial cohort of patients hospitalized with acute coronary syndromes, 2 research projects, and development of a nucleus of early stage investigators. We are currently enrolling 2500 adults hospitalized for acute coronary syndromes at 6 hospitals in the northeastern and southeastern United States. We will follow these patients for 24 months after hospitalization through medical record abstraction and 5 patient interviews focusing on quality of life, cardiac events, rehospitalizations, mortality, and medical, behavioral, and psychosocial characteristics. The Transitions Project studies determinants of and disparities in outcomes of the quality of patients' transition from hospital to community. Focusing on potentially modifiable factors, the Action Scores Project will develop and validate action scores to predict recurrent cardiac events, death, and quality of life, describe longitudinal variation in these scores, and develop a dashboard for patient and provider action on the basis of these scores. In TRACE-CORE, sound methodologic principles of observational studies converge with outcomes and effectiveness research approaches. We expect that our data, research infrastructure, and research projects will inform the development of novel secondary prevention approaches and underpin the careers of cardiovascular outcomes researchers.

Rheumatology education for undergraduate nursing, physiotherapy and occupational therapy students in the UK: standards, challenges and solutions.

PubMed

Hewlett, S; Clarke, B; O'Brien, A; Hammond, A; Ryan, S; Kay, L; Richards, P; Almeida, C

2008-07-01

Rheumatological conditions are common, thus nurses (Ns) occupational therapists (OTs) and physiotherapists (PTs) require at least basic rheumatology knowledge upon qualifying. The aim of this study was to develop a core set of teaching topics and potential ways of delivering them. A modified Delphi technique was used for clinicians to develop preliminary core sets of teaching topics for each profession. Telephone interviews with educationalists explored their views on these, and challenges and solutions for delivering them. Inter-professional workshops enabled clinicians and educationalists to finalize the core set together, and generate methods for delivery. Thirty-nine rheumatology clinicians (12N, 14OT, 13PT) completed the Delphi consensus, proposing three preliminary core sets (N71 items, OT29, PT26). Nineteen educationalists (6N, 7OT, 6PT) participated in telephone interviews, raising concerns about disease-specific vs generic teaching and proposing many methods for delivery. Three inter-professional workshops involved 34 participants (clinicians: N12, OT9, PT5; educationalists: N2, OT3, PT2; Patient 1) who reached consensus on a single core set comprising six teaching units: Anatomy and Physiology; Assessment; Management and Intervention; Psychosocial Issues; Patient Education; and the Multi-disciplinary Team, recommending some topics within the units receive greater depth for some professions. An innovative range of delivery options was generated plus two brief interventions: a Rheumatology Chat Show and a Rheumatology Road Show. Working together, clinicians and educationalists proposed a realistic core set of rheumatology topics for undergraduate health professionals. They proposed innovative delivery methods, with collaboration between educationalists, clinicians and patients strongly recommended. These potential interventions need testing.

Rheumatology education for undergraduate nursing, physiotherapy and occupational therapy students in the UK: standards, challenges and solutions

PubMed Central

Clarke, B.; O’Brien, A.; Hammond, A.; Ryan, S.; Kay, L.; Richards, P.; Almeida, C.

2008-01-01

Objectives. Rheumatological conditions are common, thus nurses (Ns) occupational therapists (OTs) and physiotherapists (PTs) require at least basic rheumatology knowledge upon qualifying. The aim of this study was to develop a core set of teaching topics and potential ways of delivering them. Methods. A modified Delphi technique was used for clinicians to develop preliminary core sets of teaching topics for each profession. Telephone interviews with educationalists explored their views on these, and challenges and solutions for delivering them. Inter-professional workshops enabled clinicians and educationalists to finalize the core set together, and generate methods for delivery. Results. Thirty-nine rheumatology clinicians (12N, 14OT, 13PT) completed the Delphi consensus, proposing three preliminary core sets (N71 items, OT29, PT26). Nineteen educationalists (6N, 7OT, 6PT) participated in telephone interviews, raising concerns about disease-specific vs generic teaching and proposing many methods for delivery. Three inter-professional workshops involved 34 participants (clinicians: N12, OT9, PT5; educationalists: N2, OT3, PT2; Patient 1) who reached consensus on a single core set comprising six teaching units: Anatomy and Physiology; Assessment; Management and Intervention; Psychosocial Issues; Patient Education; and the Multi-disciplinary Team, recommending some topics within the units receive greater depth for some professions. An innovative range of delivery options was generated plus two brief interventions: a Rheumatology Chat Show and a Rheumatology Road Show. Conclusions. Working together, clinicians and educationalists proposed a realistic core set of rheumatology topics for undergraduate health professionals. They proposed innovative delivery methods, with collaboration between educationalists, clinicians and patients strongly recommended. These potential interventions need testing. PMID:18443005

Medication Therapy Management in community pharmacy practice: core elements of an MTM service (version 1.0).

PubMed

2005-01-01

To develop a model framework of Medication Therapy Management (MTM) in community pharmacy designed to improve care, enhance communication among patients and providers, improve collaboration among providers, and optimize medication use that leads to improved patient outcomes. Peer-reviewed literature, structured discussions with community pharmacy leaders and representatives from pharmacy benefit providers and health plans, and input from pharmacists and pharmacy associations. Building on an MTM consensus definition adopted by 11 national pharmacy organizations in July 2004, this model describes core elements of an MTM service that can be provided by pharmacists across the spectrum of community pharmacy. The model is structured for pharmacists to use with all patients in need of MTM services, both in the private and public sector. The model describes five core elements of MTM in the community pharmacy setting: medication therapy review (MTR), a personal medication record (PMR), a medication action plan (MAP), intervention and referral, and documentation and follow-up. The MTR can be comprehensive or targeted, depending onthe needs of the patient. The PMR and MAP are patient-centered documents intended to be used by the patient to improve medication self-management. A collaborative approach to patient care involving patients, pharmacists, and physicians and other health care providers is advocated in the model. General patient eligibility considerations are also described. A model framework for consideration by community pharmacists in developing MTM services is described. The model consists of five core elements for MTM service delivery in community pharmacy practice.

Brazilian Portuguese version of the CORE-OM: cross-cultural adaptation of an instrument to assess the efficacy and effectiveness of psychotherapy.

PubMed

Santana, Márcia Rosane Moreira; da Silva, Marília Marques; de Moraes, Danielle Souza; Fukuda, Cláudia Cristina; Freitas, Lucia Helena; Ramos, Maria Eveline Cascardo; Fleury, Heloísa Junqueira; Evans, Chris

2015-01-01

The Clinical Outcome in Routine Evaluation - Outcome Measurement (CORE-OM) was developed in the 1990s, with the aim of assessing the efficacy and effectiveness of mental health treatments. To adapt the CORE-OM for use in the Brazilian population. The instrument was translated and adapted based on the international protocol developed by the CORE System Trust which contains seven steps: translation, semantic equivalence analysis, synthesis of the translated versions, pre-testing in the target population, data analysis and back translation. After semantic analysis, modifications were necessary in seven of the 34 original items. Changes were made to avoid repetition of words and the use of terms difficult to understand. Internal consistency analysis showed evidence of score stability in the CORE-OM adapted to Brazilian Portuguese. The instrument was successfully adapted to Brazilian Portuguese, and its semantic and conceptual properties were equivalent to those of the original instrument.

Constraining Genome-Scale Models to Represent the Bow Tie Structure of Metabolism for 13C Metabolic Flux Analysis

PubMed Central

Ando, David; Singh, Jahnavi; Keasling, Jay D.; García Martín, Héctor

2018-01-01

Determination of internal metabolic fluxes is crucial for fundamental and applied biology because they map how carbon and electrons flow through metabolism to enable cell function. 13C Metabolic Flux Analysis (13C MFA) and Two-Scale 13C Metabolic Flux Analysis (2S-13C MFA) are two techniques used to determine such fluxes. Both operate on the simplifying approximation that metabolic flux from peripheral metabolism into central “core” carbon metabolism is minimal, and can be omitted when modeling isotopic labeling in core metabolism. The validity of this “two-scale” or “bow tie” approximation is supported both by the ability to accurately model experimental isotopic labeling data, and by experimentally verified metabolic engineering predictions using these methods. However, the boundaries of core metabolism that satisfy this approximation can vary across species, and across cell culture conditions. Here, we present a set of algorithms that (1) systematically calculate flux bounds for any specified “core” of a genome-scale model so as to satisfy the bow tie approximation and (2) automatically identify an updated set of core reactions that can satisfy this approximation more efficiently. First, we leverage linear programming to simultaneously identify the lowest fluxes from peripheral metabolism into core metabolism compatible with the observed growth rate and extracellular metabolite exchange fluxes. Second, we use Simulated Annealing to identify an updated set of core reactions that allow for a minimum of fluxes into core metabolism to satisfy these experimental constraints. Together, these methods accelerate and automate the identification of a biologically reasonable set of core reactions for use with 13C MFA or 2S-13C MFA, as well as provide for a substantially lower set of flux bounds for fluxes into the core as compared with previous methods. We provide an open source Python implementation of these algorithms at https://github.com/JBEI/limitfluxtocore. PMID:29300340

The Effects of Isolated and Integrated ‘Core Stability’ Training on Athletic Performance Measures

PubMed Central

Reed, Casey A.; Ford, Kevin R.; Myer, Gregory D.; Hewett, Timothy E.

2014-01-01

Background Core stability training, operationally defined as training focused to improve trunk and hip control, is an integral part of athletic development, yet little is known about its direct relation to athletic performance. Objective This systematic review focuses on identification of the association between core stability and sports-related performance measures. A secondary objective was to identify difficulties encountered when trying to train core stability with the goal of improving athletic performance. Data sources A systematic search was employed to capture all articles related to athletic performance and core stability training that were identified using the electronic databases MEDLINE, CINAHL and SPORTDiscus™ (1982-June2011). Study selection A systematic approach was used to evaluate 179 articles identified for initial review. Studies that performed an intervention targeted toward the core and measured an outcome related to athletic or sport performances were included, while studies with a participant population aged 65 years or older were excluded. Twenty-four in total met the inclusionary criteria for review. Study appraisal and synthesis methods Studies were evaluated using the Physical Therapy Evidence Database (PEDro) scale. The 24 articles were separated into three groups, general performance (n = 8), lower extremity (n = 10) and upper extremity (n = 6), for ease of discussion. Results In the majority of studies, core stability training was utilized in conjunction with more comprehensive exercise programmes. As such, many studies saw improvements in skills of general strengths such as maximum squat load and vertical leap. Surprisingly, not all studies reported measurable increases in specific core strength and stability measures following training. Additionally, investigations that targeted the core as the primary goal for improved outcome of training had mixed results. Limitations Core stability is rarely the sole component of an athletic development programme, making it difficult to directly isolate its affect on athletic performance. The population biases of some studies of athletic performance also confound the results. Conclusions Targeted core stability training provides marginal benefits to athletic performance. Conflicting findings and the lack of a standardization for measurement of outcomes and training focused to improve core strength and stability pose difficulties. Because of this, further research targeted to determine this relationship is necessary to better understand how core strength and stability affect athletic performance. PMID:22784233

National Curricula in Norway and Finland: The Role of Learning Outcomes

ERIC Educational Resources Information Center

Mølstad, Christina Elde; Karseth, Berit

2016-01-01

The core curricular category of "learning outcomes" has entered the educational policy scene in Europe. While content-oriented curricula have dominated the Nordic countries, a shift towards outcomes can also be observed. In this article, we describe the fundamental distinctions between "Didaktik" and learning outcomes and…

Nonlinear core deflection in injection molding

NASA Astrophysics Data System (ADS)

Poungthong, P.; Giacomin, A. J.; Saengow, C.; Kolitawong, C.; Liao, H.-C.; Tseng, S.-C.

2018-05-01

Injection molding of thin slender parts is often complicated by core deflection. This deflection is caused by molten plastics race tracking through the slit between the core and the rigid cavity wall. The pressure of this liquid exerts a lateral force of the slender core causing the core to bend, and this bending is governed by a nonlinear fifth order ordinary differential equation for the deflection that is not directly in the position along the core. Here we subject this differential equation to 6 sets of boundary conditions, corresponding to 6 commercial core constraints. For each such set of boundary conditions, we develop an explicit approximate analytical solution, including both a linear term and a nonlinear term. By comparison with finite difference solutions, we find our new analytical solutions to be accurate. We then use these solutions to derive explicit analytical approximations for maximum deflections and for the core position of these maximum deflections. Our experiments on the base-gated free-tip boundary condition agree closely with our new explicit approximate analytical solution.

‘Emotional Intelligence’: Lessons from Lesions

PubMed Central

Hogeveen, J.; Salvi, C.; Grafman, J.

2018-01-01

‘Emotional intelligence’ (EI) is one of the most highly used psychological terms in popular nomenclature, yet its construct, divergent, and predictive validities are contentiously debated. Despite this debate, the EI construct is composed of a set of emotional abilities – recognizing emotional states in the self and others, using emotions to guide thought and behavior, understanding how emotions shape behavior, and emotion regulation – that undoubtedly influence important social and personal outcomes. In this review, evidence from human lesion studies is reviewed in order to provide insight into the necessary brain regions for each of these core emotional abilities. Critically, we consider how this neuropsychological evidence might help to guide efforts to define and measure EI. PMID:27647325

'Emotional Intelligence': Lessons from Lesions.

PubMed

Hogeveen, J; Salvi, C; Grafman, J

2016-10-01

'Emotional intelligence' (EI) is one of the most highly used psychological terms in popular nomenclature, yet its construct, divergent, and predictive validities are contentiously debated. Despite this debate, the EI construct is composed of a set of emotional abilities - recognizing emotional states in the self and others, using emotions to guide thought and behavior, understanding how emotions shape behavior, and emotion regulation - that undoubtedly influence important social and personal outcomes. In this review, evidence from human lesion studies is reviewed in order to provide insight into the necessary brain regions for each of these core emotional abilities. Critically, we consider how this neuropsychological evidence might help to guide efforts to define and measure EI. Copyright © 2016 Elsevier Ltd. All rights reserved.

2016 American College of Rheumatology/European League Against Rheumatism criteria for minimal, moderate, and major clinical response in adult dermatomyositis and polymyositis: An International Myositis Assessment and Clinical Studies Group/Paediatric Rheumatology International Trials Organisation Collaborative Initiative.

PubMed

Aggarwal, Rohit; Rider, Lisa G; Ruperto, Nicolino; Bayat, Nastaran; Erman, Brian; Feldman, Brian M; Oddis, Chester V; Amato, Anthony A; Chinoy, Hector; Cooper, Robert G; Dastmalchi, Maryam; Fiorentino, David; Isenberg, David; Katz, James D; Mammen, Andrew; de Visser, Marianne; Ytterberg, Steven R; Lundberg, Ingrid E; Chung, Lorinda; Danko, Katalin; García-De la Torre, Ignacio; Song, Yeong Wook; Villa, Luca; Rinaldi, Mariangela; Rockette, Howard; Lachenbruch, Peter A; Miller, Frederick W; Vencovsky, Jiri

2017-05-01

To develop response criteria for adult dermatomyositis (DM) and polymyositis (PM). Expert surveys, logistic regression, and conjoint analysis were used to develop 287 definitions using core set measures. Myositis experts rated greater improvement among multiple pairwise scenarios in conjoint analysis surveys, where different levels of improvement in 2 core set measures were presented. The PAPRIKA (Potentially All Pairwise Rankings of All Possible Alternatives) method determined the relative weights of core set measures and conjoint analysis definitions. The performance characteristics of the definitions were evaluated on patient profiles using expert consensus (gold standard) and were validated using data from a clinical trial. The nominal group technique was used to reach consensus. Consensus was reached for a conjoint analysis-based continuous model using absolute per cent change in core set measures (physician, patient, and extramuscular global activity, muscle strength, Health Assessment Questionnaire, and muscle enzyme levels). A total improvement score (range 0-100), determined by summing scores for each core set measure, was based on improvement in and relative weight of each core set measure. Thresholds for minimal, moderate, and major improvement were ≥20, ≥40, and ≥60 points in the total improvement score. The same criteria were chosen for juvenile DM, with different improvement thresholds. Sensitivity and specificity in DM/PM patient cohorts were 85% and 92%, 90% and 96%, and 92% and 98% for minimal, moderate, and major improvement, respectively. Definitions were validated in the clinical trial analysis for differentiating the physician rating of improvement (p<0.001). The response criteria for adult DM/PM consisted of the conjoint analysis model based on absolute per cent change in 6 core set measures, with thresholds for minimal, moderate, and major improvement. 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/.

Patients' functioning as predictor of nursing workload in acute hospital units providing rehabilitation care: a multi-centre cohort study

PubMed Central

2010-01-01

Background Management decisions regarding quality and quantity of nurse staffing have important consequences for hospital budgets. Furthermore, these management decisions must address the nursing care requirements of the particular patients within an organizational unit. In order to determine optimal nurse staffing needs, the extent of nursing workload must first be known. Nursing workload is largely a function of the composite of the patients' individual health status, particularly with respect to functioning status, individual need for nursing care, and severity of symptoms. The International Classification of Functioning, Disability and Health (ICF) and the derived subsets, the so-called ICF Core Sets, are a standardized approach to describe patients' functioning status. The objectives of this study were to (1) examine the association between patients' functioning, as encoded by categories of the Acute ICF Core Sets, and nursing workload in patients in the acute care situation, (2) compare the variance in nursing workload explained by the ICF Core Set categories and with the Barthel Index, and (3) validate the Acute ICF Core Sets by their ability to predict nursing workload. Methods Patients' functioning at admission was assessed using the respective Acute ICF Core Set and the Barthel Index, whereas nursing workload data was collected using an established instrument. Associations between dependent and independent variables were modelled using linear regression. Variable selection was carried out using penalized regression. Results In patients with neurological and cardiopulmonary conditions, selected ICF categories and the Barthel Index Score explained the same variance in nursing workload (44% in neurological conditions, 35% in cardiopulmonary conditions), whereas ICF was slightly superior to Barthel Index Score for musculoskeletal conditions (20% versus 16%). Conclusions A substantial fraction of the variance in nursing workload in patients with rehabilitation needs in the acute hospital could be predicted by selected categories of the Acute ICF Core Sets, or by the Barthel Index score. Incorporating ICF Core Set-based data in nursing management decisions, particularly staffing decisions, may be beneficial. PMID:21034438

Psychotherapeutic Applications of Mobile Phone-based Technologies: A Systematic Review of Current Research and Trends.

PubMed

Menon, Vikas; Rajan, Tess Maria; Sarkar, Siddharth

2017-01-01

There is a growing interest in using mobile phone technology to offer real-time psychological interventions and support. However, questions remain on the clinical effectiveness and feasibility of such approaches in psychiatric populations. Our aim was to systematically review the published literature on mobile phone apps and other mobile phone-based technology for psychotherapy in mental health disorders. To achieve this, electronic searches of PubMed, ScienceDirect, and Google Scholar were carried out in January 2016. Generated abstracts were systematically screened for eligibility to be included in the review. Studies employing psychotherapy in any form, being delivered through mobile-based technology and reporting core mental health outcomes in mental illness were included in the study. We also included trials in progress with published protocols reporting at least some outcome measures of such interventions. From a total of 1563 search results, 24 eligible articles were identified and reviewed. These included trials in anxiety disorders (8), substance use disorders (5), depression (4), bipolar disorders (3), schizophrenia and psychotic disorders (3), and attempted suicide (1). Of these, eight studies involved the use of smartphone apps and others involved personalized text messages, automated programs, or delivered empirically supported treatments. Trial lengths varied from 6 weeks to 1 year. Good overall retention rates indicated that the treatments were feasible and largely acceptable. Benefits were reported on core outcomes in mental health illness indicating efficacy of such approaches though sample sizes were small. To conclude, mobile phone-based psychotherapies are a feasible and acceptable treatment option for patients with mental disorders. However, there remains a paucity of data on their effectiveness in real-world settings, especially from low- and middle-income countries.

Rationale and design for cognitive behavioral therapy for anxiety disorders in children with autism spectrum disorder: a study protocol of a randomized controlled trial.

PubMed

Kilburn, Tina R; Sørensen, Merete Juul; Thastum, Mikael; Rapee, Ronald M; Rask, Charlotte Ulrikka; Arendt, Kristian Bech; Thomsen, Per Hove

2018-04-02

Autism spectrum disorder (ASD) is found in approximately 1% of the population and includes core symptoms that affect general and social development. Beside these core symptoms, it is suggested that up to 60% of children with ASD suffer from comorbid anxiety disorders which may further affect educational, social and general development as well as quality of life. The main goal of this study is to examine the effectiveness of a manualized cognitive behavioral therapy (CBT) anxiety program adapted for children with ASD. This study is a randomized controlled trial (RCT). Fifty children with ASD and anxiety, aged 7 to 13 years, will be randomly assigned to group CBT or a wait-list control (WL) condition. The design will follow a two (CBT and WL) by two (pre-post assessment) mixed between-within design. The control group will receive intervention after the waitlist period of 13 weeks. Primary outcomes are diagnostic status and severity of the anxiety disorders, measured with The Anxiety Disorder Interview Schedule for DSM-IV, Parent and Child Versions. Secondary outcomes are parent and child ratings on questionnaires on the child's level of anxiety and impact on everyday life. Additional outcomes entail information gathered from parents, child and teachers on the child's behavior and negative self-statements, together with social and adaptive skills. Follow-up data will be collected 3 months after intervention. This study aims to evaluate the effectiveness of a manualized CBT program in Danish children with ASD and anxiety within a mental health clinic setting. The hypothesis is that training anxiety reduction skills will decrease anxiety in children, as well as ensure better psychosocial development for the child in general. https://ClinicalTrials.gov ( NCT02908321 ). Registered 19th of September 2016.

A behavioral science/behavioral medicine core curriculum proposal for Japanese undergraduate medical education.

PubMed

Tsutsumi, Akizumi

2015-01-01

Behavioral science and behavioral medicine have not been systematically taught to Japanese undergraduate medical students. A working group under the auspices of Japanese Society of Behavioral Medicine developed an outcome-oriented curriculum of behavioral science/behavioral medicine through three processes: identifying the curriculum contents, holding a joint symposium with related societies, and defining outcomes and proposing a learning module. The behavioral science/behavioral medicine core curriculum consists of 11 units of lectures and four units of practical study. The working group plans to improve the current core curriculum by devising formative assessment methods so that students can learn and acquire attitude as well as the skills and knowledge necessary for student-centered clinical practice.

Education Business Plan 2010-13. Budget 2010: Striking the Right Balance

ERIC Educational Resources Information Center

Alberta Education, 2010

2010-01-01

The ministry has identified one core business that is an ongoing key responsibility. It is called "Core Business One: Lead and Support the Education System So That All Students Are Successful at Learning." The core business includes four goals with specific outcomes that describe the end results the ministry wants to achieve in…

The Development of a Core Curriculum Outcomes Assessment Plan for Brenau Women's College.

ERIC Educational Resources Information Center

Robinson, Patricia Webster

This paper presents results and recommendations from a literature review, the purpose of which was to: (1) find the best structure and content for a core curricular assessment plan at Brenau Women's College (Georgia); and (2) determine a reasonable evaluation plan of the core curricular assessment plan once it is implemented. The literature also…

Paramedic-Initiated CMS Sepsis Core Measure Bundle Prior to Hospital Arrival: A Stepwise Approach.

PubMed

Walchok, Jason G; Pirrallo, Ronald G; Furmanek, Douglas; Lutz, Martin; Shope, Colt; Giles, Brandi; Gue, Greta; Dix, Aaron

2017-01-01

To improve patient outcomes, the Center for Medicare and Medicaid Services (CMS) implemented core measures that outline the initial treatment of the septic patient. These measures include initial blood culture collection prior to antibiotics, adequate intravenous fluid resuscitation, and early administration of broad spectrum antibiotics. We sought to determine if Paramedics can initiate the CMS sepsis core measure bundle in the prehospital field reliably. This is a retrospective, case series from a 3rd service EMS system model in Greenville, South Carolina between November 17, 2014 and February 20, 2016. An adult Prehospital Sepsis Assessment Tool was created using the 2012 Surviving Sepsis guidelines: 2 of 3 signs of systemic inflammatory response (heart rate, respiratory rate, oral temperature) and a known or suspected source of infection. A "Sepsis Alert" was called by paramedics and upon IV access a set of blood cultures and blood for lactate analysis was collected prior to field antibiotic administration. The Sepsis Alert was compared to serum lactate levels and ICD 9 or 10 admitting diagnosis of Sepsis, Severe Sepsis, or Septic Shock. Blood culture contamination, serum lactate, and antibiotic match were determined by in-hospital laboratory analysis. A total of 120 trained paramedics called 1,185 "Sepsis Alerts" on 56,643 patients (50.3% Male, mean age 70). Patients with missing discharge diagnosis were eliminated (n = 31). The admitting diagnosis of sepsis overall was 73.5% (848/1154): Sepsis 50% (578/1154), Severe Sepsis 14.6% (169/1154), Septic Shock 8.9% (101/1154). A total of 946 blood cultures were collected in the prehospital setting, with a 95.04% (899/946) no contamination rate. Contamination was found in 4.96% (47/946). A total of 179 (18.9%) of the uncontaminated blood cultures were found to have positive growth with 720 (76.1%) having no growth. EMS administered antibiotics matched blood culture positive growth in 72% of patients. The lactate level was greater than 2.2 in 46.9% of patients. No adverse effects were reported after prehospital administration of antibiotics. This study demonstrates the successful implementation of an EMS-driven CMS Sepsis Core Measure bundle in the prehospital setting. Paramedics can acquire uncontaminated blood cultures, and safely administer antibiotics prior to hospital arrival among patients who were recognized as sepsis alerts.

Disparities in Access to Healthcare Transition Services for Adolescents with Down Syndrome.

PubMed

Nugent, James; Gorman, Gregory; Erdie-Lalena, Christine R

2018-06-01

To compare healthcare transition planning in adolescents with Down syndrome with adolescents with other special healthcare needs. Data were drawn from the 2009-2010 National Survey of Children with Special Health Care Needs, a nationally representative sample with 17 114 adolescents aged 12-17 years. Parents were asked whether providers and the study child had discussed shifting to an adult provider, changing healthcare needs, maintaining health insurance coverage, and taking responsibility for self-care. The transition core outcome was a composite measure based on the results of these 4 questions. Multivariable logistic regression determined the association between Down syndrome and the transition core outcome as well as each of the 4 individual component measures. Although 40% of adolescents with other special healthcare needs met the transition core outcome, 11.0% of adolescents with Down syndrome met this outcome. Adolescents with Down syndrome were less likely to be encouraged to take responsibility for their health (32.2% vs 78.4%). After adjustment for demographic, socioeconomic, and health-related factors, adolescents with Down syndrome had 4 times the odds of not meeting the transition core outcome. For the component measures, Down syndrome adolescents had 4 times the odds of not being encouraged to take responsibility for self-care. Medical home access increased the odds of transition preparation. Adolescents with Down syndrome experience disparities in access to transition services. Provider goals for adolescents with Down syndrome should encourage as much independence as possible in their personal care and social lives. Copyright © 2018 Elsevier Inc. All rights reserved.

Developing Consensus-Based Priority Outcome Domains for Trials in Kidney Transplantation: A Multinational Delphi Survey With Patients, Caregivers, and Health Professionals.

PubMed

Sautenet, Bénédicte; Tong, Allison; Manera, Karine E; Chapman, Jeremy R; Warrens, Anthony N; Rosenbloom, David; Wong, Germaine; Gill, John; Budde, Klemens; Rostaing, Lionel; Marson, Lorna; Josephson, Michelle A; Reese, Peter P; Pruett, Timothy L; Hanson, Camilla S; O'Donoghue, Donal; Tam-Tham, Helen; Halimi, Jean-Michel; Shen, Jenny I; Kanellis, John; Scandling, John D; Howard, Kirsten; Howell, Martin; Cross, Nick; Evangelidis, Nicole; Masson, Philip; Oberbauer, Rainer; Fung, Samuel; Jesudason, Shilpa; Knight, Simon; Mandayam, Sreedhar; McDonald, Stephen P; Chadban, Steve; Rajan, Tasleem; Craig, Jonathan C

2017-08-01

Inconsistencies in outcome reporting and frequent omission of patient-centered outcomes can diminish the value of trials in treatment decision making. We identified critically important outcome domains in kidney transplantation based on the shared priorities of patients/caregivers and health professionals. In a 3-round Delphi survey, patients/caregivers and health professionals rated the importance of outcome domains for trials in kidney transplantation on a 9-point Likert scale and provided comments. During rounds 2 and 3, participants rerated the outcomes after reviewing their own score, the distribution of the respondents' scores, and comments. We calculated the median, mean, and proportion rating 7 to 9 (critically important), and analyzed comments thematically. One thousand eighteen participants (461 [45%] patients/caregivers and 557 [55%] health professionals) from 79 countries completed round 1, and 779 (77%) completed round 3. The top 8 outcomes that met the consensus criteria in round 3 (mean, ≥7.5; median, ≥8; proportion, >85%) in both groups were graft loss, graft function, chronic rejection, acute rejection, mortality, infection, cancer (excluding skin), and cardiovascular disease. Compared with health professionals, patients/caregivers gave higher priority to 6 outcomes (mean difference of 0.5 or more): skin cancer, surgical complications, cognition, blood pressure, depression, and ability to work. We identified 5 themes: capacity to control and inevitability, personal relevance, debilitating repercussions, gaining awareness of risks, and addressing knowledge gaps. Graft complications and severe comorbidities were critically important for both stakeholder groups. These stakeholder-prioritized outcomes will inform the core outcome set to improve the consistency and relevance of trials in kidney transplantation.

Low Cerebral Blood Volume Identifies Poor Outcome in Stent Retriever Thrombectomy

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

Protto, Sara, E-mail: sara.protto@pshp.fi; Pienimäki, Juha-Pekka; Seppänen, Janne

BackgroundMechanical thrombectomy (MT) is an efficient treatment of acute stroke caused by large-vessel occlusion. We evaluated the factors predicting poor clinical outcome (3-month modified Rankin Scale, mRS >2) although MT performed with modern stent retrievers.MethodsWe prospectively collected the clinical and imaging data of 105 consecutive anterior circulation stroke patients who underwent MT after multimodal CT imaging. Patients with occlusion of the internal carotid artery and/or middle cerebral artery up to the M2 segment were included. We recorded baseline clinical, procedural and imaging variables, technical outcome, 24-h imaging outcome and the clinical outcome. Differences between the groups were studied with appropriatemore » statistical tests and binary logistic regression analysis.ResultsLow cerebral blood volume Alberta stroke program early CT score (CBV-ASPECTS) was associated with poor clinical outcome (median 7 vs. 9, p = 0.01). Lower collateral score (CS) significantly predicted poor outcome in regression modelling with CS = 0 increasing the odds of poor outcome 4.4-fold compared to CS = 3 (95% CI 1.27–15.5, p = 0.02). Lower CBV-ASPECTS significantly predicted poor clinical outcome among those with moderate or severe stroke (OR 0.82, 95% CI 0.68–1, p = 0.05) or poor collateral circulation (CS 0–1, OR 0.66, 95% CI 0.48–0.90, p = 0.009) but not among those with mild strokes or good collaterals.ConclusionsCBV-ASPECTS estimating infarct core is a significant predictor of poor clinical outcome among anterior circulation stroke patients treated with MT, especially in the setting of poor collateral circulation and/or moderate or severe stroke.« less

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.

The National United States Center Data Repository: Core essential interprofessional practice & education data enabling triple aim analytics.

PubMed

Pechacek, Judith; Shanedling, Janet; Lutfiyya, May Nawal; Brandt, Barbara F; Cerra, Frank B; Delaney, Connie White

2015-01-01

Understanding the impact that interprofessional education and collaborative practice (IPECP) might have on triple aim patient outcomes is of high interest to health care providers, educators, administrators, and policy makers. Before the work undertaken by the National Center for Interprofessional Practice and Education at the University of Minnesota, no standard mechanism to acquire and report outcome data related to interprofessional education and collaborative practice and its effect on triple aim outcomes existed. This article describes the development and adoption of the National Center Data Repository (NCDR) designed to capture data related to IPECP processes and outcomes to support analyses of the relationship of IPECP on the Triple Aim. The data collection methods, web-based survey design and implementation process are discussed. The implications of this informatics work to the field of IPECP and health care quality and safety include creating standardized capacity to describe interprofessional practice and measure outcomes connecting interprofessional education and collaborative practice to the triple aim within and across sites/settings, leveraging an accessible data collection process using user friendly web-based survey design to support large data scholarship and instrument testing, and establishing standardized data elements and variables that can potentially lead to enhancements to national/international information system and academic accreditation standards to further team-based, interprofessional, collaborative research in the field.

Association of housing first implementation and key outcomes among homeless persons with problematic substance use.

PubMed

Davidson, Clare; Neighbors, Charles; Hall, Gerod; Hogue, Aaron; Cho, Richard; Kutner, Bryan; Morgenstern, Jon

2014-11-01

Housing First is a supportive housing model for persons with histories of chronic homelessness that emphasizes client-centered services, provides immediate housing, and does not require treatment for mental illness or substance abuse as a condition of participation. Previous studies of Housing First have found reduced governmental costs and improved personal well-being among participants. However, variations in real-world program implementation require better understanding of the relationship between implementation and outcomes. This study investigated the effects of Housing First implementation on housing and substance use outcomes. Study participants were 358 individuals with histories of chronic homelessness and problematic substance use. Clients were housed in nine scatter-site Housing First programs in New York City. Program fidelity was judged across a set of core Housing First components. Client interviews at baseline and 12 months were used to assess substance use. Clients in programs with greater fidelity to consumer participation components of Housing First were more likely to be retained in housing and were less likely to report using stimulants or opiates at follow-up. Consistently implemented Housing First principles related to consumer participation were associated with superior housing and substance use outcomes among chronically homeless individuals with a history of substance use problems. The study findings suggest that program implementation is central to understanding the potential of Housing First to help clients achieve positive housing and substance use outcomes.

The National United States Center Data Repository: Core essential interprofessional practice & education data enabling triple aim analytics

PubMed Central

Pechacek, Judith; Shanedling, Janet; Lutfiyya, May Nawal; Brandt, Barbara F.; Cerra, Frank B.; Delaney, Connie White

2015-01-01

Abstract Understanding the impact that interprofessional education and collaborative practice (IPECP) might have on triple aim patient outcomes is of high interest to health care providers, educators, administrators, and policy makers. Before the work undertaken by the National Center for Interprofessional Practice and Education at the University of Minnesota, no standard mechanism to acquire and report outcome data related to interprofessional education and collaborative practice and its effect on triple aim outcomes existed. This article describes the development and adoption of the National Center Data Repository (NCDR) designed to capture data related to IPECP processes and outcomes to support analyses of the relationship of IPECP on the Triple Aim. The data collection methods, web-based survey design and implementation process are discussed. The implications of this informatics work to the field of IPECP and health care quality and safety include creating standardized capacity to describe interprofessional practice and measure outcomes connecting interprofessional education and collaborative practice to the triple aim within and across sites/settings, leveraging an accessible data collection process using user friendly web-based survey design to support large data scholarship and instrument testing, and establishing standardized data elements and variables that can potentially lead to enhancements to national/international information system and academic accreditation standards to further team-based, interprofessional, collaborative research in the field. PMID:26652631

Relating dispositional mindfulness, contemplative practice, and positive reappraisal with posttraumatic cognitive coping, stress, and growth.

PubMed

Hanley, Adam W; Garland, Eric L; Tedeschi, Richard G

2017-09-01

A growing body of theoretical and empirical work suggests that mindfulness may support more positive posttraumatic outcomes by reducing posttraumatic stress (PTS) and encouraging posttraumatic growth (PTG). Positive reappraisal (PR), a cognitive coping correlate of dispositional mindfulness (DM) has also been linked with greater PTG. However, neither DM nor PR have been modeled in relation to core posttraumatic constructs such as core belief disruption, intrusive rumination, deliberate rumination, PTS and PTG. This study explored associations between these constructs in a sample of college students (N = 505), also investigating the impact of contemplative practice involvement on the relationships between the constructs. Results indicate that including DM and PR into established models of PTG increases the model's explanatory power, which distinct cognitive coping pathways connect DM and core belief disruption with PTS as well as PTG, and that contemplative practice involvement substantially alters relationships between the core PTG variables. The present study contributes to the growing reconceptualization of trauma as linked with both positive and pathogenic outcomes, emphasizing the need to better understand how posttraumatic cognitive coping strategies contribute to more positive outcomes. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

The role of empowerment in youth development: a study of sociopolitical control as mediator of ecological systems' influence on developmental outcomes.

PubMed

Christens, Brian D; Peterson, N Andrew

2012-05-01

Empowerment has become an influential concept and theoretical framework for social policy and practice. Still, relatively little is known about the roles that empowerment plays in the ecology of human development, particularly among young people. This article reports results of a study of psychological empowerment among young people, using data from 629 high school students (65.8% female; 96.5% non-white). Using a path analysis, we examined the role of perceived sociopolitical control--an indicator of the intrapersonal component of psychological empowerment--as a mediator between ecological support systems and developmental outcomes. Findings confirmed that social support in family, peer, and school settings, and family cohesion positively predict self-esteem and perceived school importance, which, in turn, have protective effects on psychological symptoms, violent behaviors and substance use. Sociopolitical control was found to mediate the relationships between ecological supports and risk factors and developmental outcomes, leading to the conclusion that perceived efficacy in the sociopolitical domain, and youth empowerment, more generally, should be considered as core elements of the ecology of human development. Policy and practice aimed at promoting positive developmental outcomes and preventing risk behaviors should take their relationship to sociopolitical control into account.

Towards a Job Demands-Resources Health Model: Empirical Testing with Generalizable Indicators of Job Demands, Job Resources, and Comprehensive Health Outcomes.

PubMed

Brauchli, Rebecca; Jenny, Gregor J; Füllemann, Désirée; Bauer, Georg F

2015-01-01

Studies using the Job Demands-Resources (JD-R) model commonly have a heterogeneous focus concerning the variables they investigate-selective job demands and resources as well as burnout and work engagement. The present study applies the rationale of the JD-R model to expand the relevant outcomes of job demands and job resources by linking the JD-R model to the logic of a generic health development framework predicting more broadly positive and negative health. The resulting JD-R health model was operationalized and tested with a generalizable set of job characteristics and positive and negative health outcomes among a heterogeneous sample of 2,159 employees. Applying a theory-driven and a data-driven approach, measures which were generally relevant for all employees were selected. Results from structural equation modeling indicated that the model fitted the data. Multiple group analyses indicated invariance across six organizations, gender, job positions, and three times of measurement. Initial evidence was found for the validity of an expanded JD-R health model. Thereby this study contributes to the current research on job characteristics and health by combining the core idea of the JD-R model with the broader concepts of salutogenic and pathogenic health development processes as well as both positive and negative health outcomes.

DUBLIN CORE

EPA Science Inventory

The Dublin Core is a metadata element set intended to facilitate discovery of electronic resources. It was originally conceived for author-generated descriptions of Web resources, and the Dublin Core has attracted broad ranging international and interdisciplinary support. The cha...

Involving patients in setting priorities for healthcare improvement: a cluster randomized trial

PubMed Central

2014-01-01

Background Patients are increasingly seen as active partners in healthcare. While patient involvement in individual clinical decisions has been extensively studied, no trial has assessed how patients can effectively be involved in collective healthcare decisions affecting the population. The goal of this study was to test the impact of involving patients in setting healthcare improvement priorities for chronic care at the community level. Methods Design: Cluster randomized controlled trial. Local communities were randomized in intervention (priority setting with patient involvement) and control sites (no patient involvement). Setting: Communities in a canadian region were required to set priorities for improving chronic disease management in primary care, from a list of 37 validated quality indicators. Intervention: Patients were consulted in writing, before participating in face-to-face deliberation with professionals. Control: Professionals established priorities among themselves, without patient involvement. Participants: A total of 172 individuals from six communities participated in the study, including 83 chronic disease patients, and 89 health professionals. Outcomes: The primary outcome was the level of agreement between patients’ and professionals’ priorities. Secondary outcomes included professionals’ intention to use the selected quality indicators, and the costs of patient involvement. Results Priorities established with patients were more aligned with core generic components of the Medical Home and Chronic Care Model, including: access to primary care, self-care support, patient participation in clinical decisions, and partnership with community organizations (p < 0.01). Priorities established by professionals alone placed more emphasis on the technical quality of single disease management. The involvement intervention fostered mutual influence between patients and professionals, which resulted in a 41% increase in agreement on common priorities (95%CI: +12% to +58%, p < 0.01). Professionals’ intention to use the selected quality indicators was similar in intervention and control sites. Patient involvement increased the costs of the prioritization process by 17%, and required 10% more time to reach consensus on common priorities. Conclusions Patient involvement can change priorities driving healthcare improvement at the population level. Future research should test the generalizability of these findings to other contexts, and assess its impact on patient care. Trial registration The Netherlands National Trial Register #NTR2496. PMID:24555508

Assembly of large metagenome data sets using a Convey HC-1 hybrid core computer (7th Annual SFAF Meeting, 2012)

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

Copeland, Alex

2012-06-01

Alex Copeland on "Assembly of large metagenome data sets using a Convey HC-1 hybrid core computer" at the 2012 Sequencing, Finishing, Analysis in the Future Meeting held June 5-7, 2012 in Santa Fe, New Mexico.

Terrestrail indicators and measurements: Selection process and preliminary recommendations

USDA-ARS?s Scientific Manuscript database

The objective of this project is to identify a small set of core indicators and measurements that can be applied across rangeland, forest and riparian ecosystems managed by the BLM. A set of core indicators quantified using standardized measurements allows data to be integrated across field office, ...

Assembly of large metagenome data sets using a Convey HC-1 hybrid core computer (7th Annual SFAF Meeting, 2012)

ScienceCinema

Copeland, Alex [DOE JGI

2017-12-09

Alex Copeland on "Assembly of large metagenome data sets using a Convey HC-1 hybrid core computer" at the 2012 Sequencing, Finishing, Analysis in the Future Meeting held June 5-7, 2012 in Santa Fe, New Mexico.

A randomized trial of face-to-face counselling versus telephone counselling versus bibliotherapy for occupational stress.

PubMed

Kilfedder, Catherine; Power, Kevin; Karatzias, Thanos; McCafferty, Aileen; Niven, Karen; Chouliara, Zoë; Galloway, Lisa; Sharp, Stephen

2010-09-01

The aim of the present study was to compare the effectiveness and acceptability of three interventions for occupational stress. A total of 90 National Health Service employees were randomized to face-to-face counselling or telephone counselling or bibliotherapy. Outcomes were assessed at post-intervention and 4-month follow-up. Clinical Outcomes in Routine Evaluation (CORE), General Health Questionnaire (GHQ-12), and Perceived Stress Scale (PSS-10) were used to evaluate intervention outcomes. An intention-to-treat analyses was performed. Repeated measures analysis revealed significant time effects on all measures with the exception of CORE Risk. No significant group effects were detected on all outcome measures. No time by group significant interaction effects were detected on any of the outcome measures with the exception of CORE Functioning and GHQ total. With regard to acceptability of interventions, participants expressed a preference for face-to-face counselling over the other two modalities. Overall, it was concluded that the three intervention groups are equally effective. Given that bibliotherapy is the least costly of the three, results from the present study might be considered in relation to a stepped care approach to occupational stress management with bibliotherapy as the first line of intervention, followed by telephone and face-to-face counselling as required.

SPRUCE Whole Ecosystem Warming (WEW) Peat Water Content and Temperature Profiles for Experimental Plot Cores Beginning June 2016

DOE Data Explorer

Gutknecht, J. [Oak Ridge National Laboratory, U.S. Department of Energy, Oak Ridge, Tennessee, U.S.A.; Kluber, L. A. [Oak Ridge National Laboratory, U.S. Department of Energy, Oak Ridge, Tennessee, U.S.A.; Hanson, P. J. [Oak Ridge National Laboratory, U.S. Department of Energy, Oak Ridge, Tennessee, U.S.A.; Schadt, C. W. [Oak Ridge National Laboratory, U.S. Department of Energy, Oak Ridge, Tennessee, U.S.A.

2016-06-01

This data set provides the peat water content and peat temperature at time of sampling for peat cores collected before and during the SPRUCE Whole Ecosystem Warming (WEW) study. Cores for the current data set were collected during the following bulk peat sampling events: 13 June 2016 and 23 August 2016. Over time, this dataset will be updated with each new major bulk peat sampling event, and dates/methods will be updated accordingly.

Studies toward the synthesis of palhinine lycopodium alkaloids: a Morita-Baylis-Hillman/intramolecular Diels-Alder approach.

PubMed

Sizemore, Nicholas; Rychnovsky, Scott D

2014-02-07

A synthetic route to the isotwistane core of palhinine lycopodium alkaloids is described. A Morita-Baylis-Hillman/intramolecular Diels-Alder (IMDA) strategy sets the vicinal all-carbon quaternary centers present in this family of natural products. The regioselectivity of the IMDA reaction is dictated by the conditions employed for silyl enol ether formation, with one set of conditions providing the core of cardionine and alternate conditions generating the desired isotwistane core of isopalhinine.

[Functioning and disability: the International Classification of Functioning, Disability and Health (ICF)].

PubMed

Fernández-López, Juan Antonio; Fernández-Fidalgo, María; Geoffrey, Reed; Stucki, Gerold; Cieza, Alarcos

2009-01-01

The World Health Organization's International Classification of Functioning, Disability and Health (ICF) has provided a new foundation for our understanding of health, functioning, and disability. It covers most of the health and health-related domains that make up the human experience, and the most environmental factors that influence that experience of functioning and disability. With the exhaustive ICF, patients' functioning -including its components body functions and structures and activities and participation-, becomes a central perspective in medicine. To implement the ICF in medicine and other fields, practical tools (= ICF Core Sets) have been developed. They are selected sets of categories out of the whole classification which serve as minimal standards for the assessment and reporting of functioning and health for clinical studies and clinical encounters (Brief ICF Core Set) or as standards for multiprofessional comprehensive assessment (Comprehensive ICF Core Set). Different from generic and condition-specific health-status measures, the ICF Core Sets include important body functions and structures and contextual factors. The use of the ICF Core Sets provides an important step towards improved communications between healthcare providers and professionals, and will enable patients and their families to understand and communicate with health professionals about their functioning and treatment goals. Specific applications include multi- and interdisciplinary assessment in clinical settings and in legal expert evaluations and use in disease or functioning-management programs. The ICF has also a potential as a conceptual framework to clarify an interrelated universe of health-related concepts which can be elucidated based on the ICF and therefore will be an ideal tool for teaching students in all medical fields and may open doors to multi-professional learning.

Identifying Deteriorating Patients Through Multidisciplinary Team Training.

PubMed

Merriel, Abi; van der Nelson, Helen; Merriel, Sam; Bennett, Joanne; Donald, Fiona; Draycott, Timothy; Siassakos, Dimitrios

2016-11-01

Multidisciplinary training has improved maternity outcomes when the training has been well attended, regular, in house, used high-fidelity simulators, and integrated teamwork training. If these principles were used in other settings, better clinical care may result. This before-after study sought to establish whether a short multidisciplinary training intervention can improve recognition of the deteriorating patient using an aggregated physiological parameter scoring system (Early Warning Score [EWS]). Nursing, medical, and allied nursing staff participated in an hour-long training session, using real-life scenarios with simple tools and structured debriefing. After training, staff were more likely to calculate EWS scores correctly (68.02% vs 55.12%; risk ratio [RR] = 1.24, 95% confidence interval [CI] = 1.07-1.44), and observations were more likely to be performed at the correct frequency (78.57% vs 68.09%; RR = 1.20, 95% CI = 1.09-1.32). Multidisciplinary training, according to core principles, can lead to more accurate identification of deteriorating patients, with implications for subsequent care and outcome. © The Author(s) 2015.

Sonosensitive MRI nanosystems as Cancer Theranostics: a recent update

NASA Astrophysics Data System (ADS)

Garello, Francesca; Terreno, Enzo

2018-05-01

In the tireless search for innovative and more efficient cancer therapies, sonosensitive Magnetic Resonance Imaging (MRI) agents play an important role. Basically, these systems consist of nano/microvesicles composed by a biocompatible membrane, responsive to ultrasound-induced thermal or mechanical effects, and an aqueous core, filled up with a MRI detectable probe and a therapeutic agent. They offer the possibility to trigger and monitor in real time drug release in a spatio-temporal domain, with the expectation to predict the therapeutic outcome. In this review, the key items to design sonosensitive MRI agents will be examined and an overview on the different approaches available so far will be given. Due to the extremely wide range of adopted ultrasound settings and formulations conceived, it is hard to compare the numerous preclinical studies reported. However, in general, a significantly better therapeutic outcome was noticed when exploiting ultrasound triggered drug release in comparison to traditional therapies, thus paving the way to the possible clinical translation of optimized sonosensitive MRI agents.

New approaches to trials in glomerulonephritis.

PubMed

Craig, Jonathan C; Tong, Allison; Strippoli, Giovanni F M

2017-01-01

Randomized controlled trials are required to reliably identify interventions to improve the outcomes for people with glomerulonephritis (GN). Unfortunately, although easier, observational studies are inherently unreliable even though the findings of both study designs agree most of the time. Currently there are ∼790 trials in GN, but suboptimal design and reporting, together with small sample sizes, mean that they may not be reliable for decision making. If the history is somewhat bleak, the future looks bright, with recent initiatives to improve the quality, size and relevance of clinical trials in nephrology, including greater patient engagement, trial networks, core outcome sets, registry-based trials and adaptive designs. Given the current state of the evidence informing the care of people with GN, disruptive technologies and pervasive culture change is required to ensure that the potential of trials to improve the health of people with this complex condition is to be realized. © The Author 2017. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.

Management of non-traumatic avascular necrosis of the femoral head-a comparative analysis of the outcome of multiple small diameter drilling and core decompression with fibular grafting.

PubMed

Mohanty, S P; Singh, K A; Kundangar, R; Shankar, V

2017-04-01

The purpose of this study was to compare the clinical and radiological outcomes of multiple small diameter drilling and core decompression with fibular strut grafting in the management of non-traumatic avascular necrosis (AVN) of the femoral head. Outcomes of patients with AVN treated by multiple small diameter drilling (group 1) were compared retrospectively with patients treated by core decompression and fibular grafting (group 2). Harris hip score (HHS) was used to assess the clinical status pre- and postoperatively. Modified Ficat and Arlet classification was used to assess the radiological stage pre- and postoperatively. Forty-six patients (68 hips) were included in this study. Group 1 consisted of 33 hips, and group 2 consisted of 35 hips. In stages I and IIB, there was no statistically significant difference in the final HHS between the two groups. However, in stages IIA and III, hips in group 2 had a better final HHS (P < 0.05). In terms of radiographic progression, there was no statistical difference between hips in stages I, IIA and stage IIB. However, in stage III, hips belonging to group 2 had better results (P < 0.05). Kaplan-Meier survivorship analysis showed better outcome in group 2 in stage III (P < 0.05). Hips with AVN in the precollapse stage can be salvaged by core decompression with or without fibular grafting. Multiple small diameter drilling is relatively simple and carries less morbidity and hence preferred in stages I and II. However, in stage III disease, core decompression with fibular strut grafting gives better results.

MRI Evaluation of Post Core Decompression Changes in Avascular Necrosis of Hip

PubMed Central

Marupaka, Sravan Kumar; Alluri, Swathi; MD, Naseeruddin; Irfan, Kazi Amir; Jampala, Venkateshwarlu; Apsingi, Sunil; Eachempati, Krishna Kiran

2015-01-01

Introduction Avascular necrosis of hip typically presents in young patients. Core decompression in precollapse stage provides pain relief and preservation of femoral head. The results of core decompression vary considerably despite early diagnosis. The role of MRI in monitoring patients post surgically has not been clearly defined. Aim To study pre and post core decompression MRI changes in avascular necrosis of hip. Materials and Methods This is a contiguous observational cohort of 40 hips treated by core decompression for precollapse avascular necrosis of femoral head, who had a baseline MRI performed before surgery. Core decompression of the femoral head was performed within 4 weeks. Follow up radiograph and MRI scans were done at six months. Harris hip score preoperatively, 1 month and 6 months after the surgery was noted. Success in this study was defined as postoperative increase in Harris hip score (HHS) by 20 points and no additional femoral collapse. End point of clinical adverse outcome as defined by fall in Harris hip score was conversion or intention to convert to total hip replacement (THR). MRI parameters in the follow up scan were compared to the preoperative MRI. Effect of core decompression on bone marrow oedema and femoral head collapse was noted. Results were analysed using SPSS software version. Results Harris hip score improved from 57 to 80 in all patients initially. Six hips had a fall in Harris hip score to mean value of 34.1 during follow up (9 to 12 months) and underwent total hip replacement. MRI predictors of positive outcome are lesions with grade A extent, Grade A & B location. Bone marrow oedema with lesions less than 50% involvement, medial and central location. Conclusion Careful selection of patients by MR criteria for core decompression provides satisfactory outcome in precollapse stage of avascular necrosis of hip. PMID:26816966

Validity and measurement precision of the PROMIS physical function item bank and a content validity-driven 20-item short form in rheumatoid arthritis compared with traditional measures.

PubMed

Oude Voshaar, Martijn A H; Ten Klooster, Peter M; Glas, Cees A W; Vonkeman, Harald E; Taal, Erik; Krishnan, Eswar; Bernelot Moens, Hein J; Boers, Maarten; Terwee, Caroline B; van Riel, Piet L C M; van de Laar, Mart A F J

2015-12-01

To evaluate the content validity and measurement properties of the Patient-Reported Outcome Measurement Information System (PROMIS) physical function item bank and a 20-item short form in patients with RA in comparison with the HAQ disability index (HAQ-DI) and 36-item Short Form Health Survey (SF-36) physical functioning scale (PF-10). The content validity of the instruments was evaluated by linking their items to the International Classification of Functioning, Disability and Health (ICF) core set for RA. The measures were administered to 690 RA patients enrolled in the Dutch Rheumatoid Arthritis Monitoring registry. Measurement precision was evaluated using item response theory methods and construct validity was evaluated by correlating physical function scores with other clinical and patient-reported outcome measures. All 207 health concepts identified in the physical function measures referred to activities that are featured in the ICF. Twenty-three of 26 ICF RA core set domains are featured in the full PROMIS physical function item bank compared with 13 and 8 for the HAQ-DI and PF-10, respectively. As hypothesized, all three physical function instruments were highly intercorrelated (r 0.74-0.84), moderately correlated with disease activity measures (r 0.44-0.63) and weakly correlated with age (rs 0.07-0.14). Item response theory-based analysis revealed that a 20-item PROMIS physical function short form covered a wider range of physical function levels than the HAQ-DI or PF-10. The PROMIS physical function item bank demonstrated excellent measurement properties in RA. A content-driven 20-item short form may be a useful tool for assessing physical function in RA. © The Author 2015. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

A Global Oral Health Survey of professional opinion using the International Classification of Functioning, Disability and Health.

PubMed

Dougall, Alison; Molina, Gustavo F; Eschevins, Caroline; Faulks, Denise

2015-06-01

The concept of oral health is frequently reduced to the absence of disease, despite existing conceptual models exploring the wider determinants of oral health and quality of life. The International Classification of Functioning, Disability and Health (ICF) (WHO) is designed to qualify functional, social and environmental aspects of health. This survey aimed to reach a consensual description of adult oral health, derived from the ICF using international professional opinion. The Global Oral Health Survey involved a two-round, online survey concerning factors related to oral health including functioning, participation and social environment. Four hundred eighty-six oral health professionals from 74 countries registered online. Professionals were pooled into 18 groups of six WHO world regions and three professional groups. In a randomised stratification process, eight professionals from each pool (n=144) completed the survey. The first round consisted of eight open-ended questions. Open expression replies were analysed for meaningful concepts and linked using established rules to the ICF. In Round 2, items were rated for their relevance to oral health (88% response rate). Eighty-nine ICF items and 30 other factors were considered relevant by at least 80% of participants. International professionals reached consensus on a holistic description of oral health, which could be qualified and quantified using the ICF. These results represent the first step towards developing an ICF Core Set in Oral Health, which would provide a practical tool for reporting outcome measures in clinical practice, for research and epidemiology, and for the improvement of interdisciplinary communication regarding oral health. Professional consensus reached in this survey is the foundation stone for developing an ICF Core Set in Oral Health, allowing the holistic aspects of oral health to be qualified and quantified. This tool is necessary to widen our approach to clinical decision making, measurement of clinical outcomes, research and epidemiology. Copyright © 2015 Elsevier Ltd. All rights reserved.

Hardware/software codesign for embedded RISC core

NASA Astrophysics Data System (ADS)

Liu, Peng

2001-12-01

This paper describes hardware/software codesign method of the extendible embedded RISC core VIRGO, which based on MIPS-I instruction set architecture. VIRGO is described by Verilog hardware description language that has five-stage pipeline with shared 32-bit cache/memory interface, and it is controlled by distributed control scheme. Every pipeline stage has one small controller, which controls the pipeline stage status and cooperation among the pipeline phase. Since description use high level language and structure is distributed, VIRGO core has highly extension that can meet the requirements of application. We take look at the high-definition television MPEG2 MPHL decoder chip, constructed the hardware/software codesign virtual prototyping machine that can research on VIRGO core instruction set architecture, and system on chip memory size requirements, and system on chip software, etc. We also can evaluate the system on chip design and RISC instruction set based on the virtual prototyping machine platform.

Nucleus Accumbens Core and Shell Differentially Encode Reward-Associated Cues after Reinforcer Devaluation

PubMed Central

West, Elizabeth A.

2016-01-01

Nucleus accumbens (NAc) neurons encode features of stimulus learning and action selection associated with rewards. The NAc is necessary for using information about expected outcome values to guide behavior after reinforcer devaluation. Evidence suggests that core and shell subregions may play dissociable roles in guiding motivated behavior. Here, we recorded neural activity in the NAc core and shell during training and performance of a reinforcer devaluation task. Long–Evans male rats were trained that presses on a lever under an illuminated cue light delivered a flavored sucrose reward. On subsequent test days, each rat was given free access to one of two distinctly flavored foods to consume to satiation and were then immediately tested on the lever pressing task under extinction conditions. Rats decreased pressing on the test day when the reinforcer earned during training was the sated flavor (devalued) compared with the test day when the reinforcer was not the sated flavor (nondevalued), demonstrating evidence of outcome-selective devaluation. Cue-selective encoding during training by NAc core (but not shell) neurons reliably predicted subsequent behavioral performance; that is, the greater the percentage of neurons that responded to the cue, the better the rats suppressed responding after devaluation. In contrast, NAc shell (but not core) neurons significantly decreased cue-selective encoding in the devalued condition compared with the nondevalued condition. These data reveal that NAc core and shell neurons encode information differentially about outcome-specific cues after reinforcer devaluation that are related to behavioral performance and outcome value, respectively. SIGNIFICANCE STATEMENT Many neuropsychiatric disorders are marked by impairments in behavioral flexibility. Although the nucleus accumbens (NAc) is required for behavioral flexibility, it is not known how NAc neurons encode this information. Here, we recorded NAc neurons during a training session in which rats learned that a cue predicted a specific reward and during a test session when that reward value was changed. Although encoding in the core during training predicted the ability of rats to change behavior after the reward value was altered, the NAc shell encoded information about the change in reward value during the test session. These findings suggest differential roles of the core and shell in behavioral flexibility. PMID:26818502

STOCHASTICITY AND EFFICIENCY IN SIMPLIFIED MODELS OF CORE-COLLAPSE SUPERNOVA EXPLOSIONS

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

Cardall, Christian Y.; Budiardja, Reuben D., E-mail: cardallcy@ornl.gov, E-mail: reubendb@utk.edu

2015-11-01

We present an initial report on 160 simulations of a highly simplified model of the post-bounce core-collapse supernova environment in three spatial dimensions (3D). We set different values of a parameter characterizing the impact of nuclear dissociation at the stalled shock in order to regulate the post-shock fluid velocity, thereby determining the relative importance of convection and the stationary accretion shock instability (SASI). While our convection-dominated runs comport with the paradigmatic notion of a “critical neutrino luminosity” for explosion at a given mass accretion rate (albeit with a nontrivial spread in explosion times just above threshold), the outcomes of ourmore » SASI-dominated runs are much more stochastic: a sharp threshold critical luminosity is “smeared out” into a rising probability of explosion over a ∼20% range of luminosity. We also find that the SASI-dominated models are able to explode with 3–4 times less efficient neutrino heating, indicating that progenitor properties, and fluid and neutrino microphysics, conducive to the SASI would make the neutrino-driven explosion mechanism more robust.« less

Informational Leadership...Leading with the End in Mind

ERIC Educational Resources Information Center

Sommers, Denise

2009-01-01

The leadership of any organization is responsible for setting and communicating a mission, an inspiring vision and a set of core values. The leadership is also responsible for establishing a management system to achieve the missions and vision while adhering to core values. Many organizations do an excellent job of creating the mission, vision and…

Information Leadership... Leading with the End in Mind

ERIC Educational Resources Information Center

Sommers, Denise

2009-01-01

The leadership of any organization is responsible for setting and communicating a mission, an inspiring vision and a set of core values. The leadership is also responsible for establishing a management system to achieve the missions and vision while adhering to core values. Many organizations do an excellent job of creating the mission, vision and…

Common Core State Standards 101

ERIC Educational Resources Information Center

Rothman, Robert

2013-01-01

The Common Core State Standards (CCSS) represent the first time that nearly every state has set common expectations for what students should know and be able to do. In the past, each state set its own standards, and the results varied widely. And while states collectively developed these common standards, decisions about the curriculum and…

Perspiring Capitalists: Latinos and the Henry Ford Service School, 1918-1928.

ERIC Educational Resources Information Center

Valdes, Dennis Nodin

1981-01-01

The Ford Service School was a program established by the Ford Motor Company to train a small core of highly educated, well-connected men to set up the most important automotive empire in Latin America. This core group was crucial in setting up sales branches and assembly plants in foreign markets. (NQA)

"Functional" Inspiratory and Core Muscle Training Enhances Running Performance and Economy.

PubMed

Tong, Tomas K; McConnell, Alison K; Lin, Hua; Nie, Jinlei; Zhang, Haifeng; Wang, Jiayuan

2016-10-01

Tong, TK, McConnell, AK, Lin, H, Nie, J, Zhang, H, and Wang, J. "Functional" inspiratory and core muscle training enhances running performance and economy. J Strength Cond Res 30(10): 2942-2951, 2016-We compared the effects of two 6-week high-intensity interval training interventions. Under the control condition (CON), only interval training was undertaken, whereas under the intervention condition (ICT), interval training sessions were followed immediately by core training, which was combined with simultaneous inspiratory muscle training (IMT)-"functional" IMT. Sixteen recreational runners were allocated to either ICT or CON groups. Before the intervention phase, both groups undertook a 4-week program of "foundation" IMT to control for the known ergogenic effect of IMT (30 inspiratory efforts at 50% maximal static inspiratory pressure [P0] per set, 2 sets per day, 6 days per week). The subsequent 6-week interval running training phase consisted of 3-4 sessions per week. In addition, the ICT group undertook 4 inspiratory-loaded core exercises (10 repetitions per set, 2 sets per day, inspiratory load set at 50% post-IMT P0) immediately after each interval training session. The CON group received neither core training nor functional IMT. After the intervention phase, global inspiratory and core muscle functions increased in both groups (p ≤ 0.05), as evidenced by P0 and a sport-specific endurance plank test (SEPT) performance, respectively. Compared with CON, the ICT group showed larger improvements in SEPT, running economy at the speed of the onset of blood lactate accumulation, and 1-hour running performance (3.04% vs. 1.57%, p ≤ 0.05). The changes in these variables were interindividually correlated (r ≥ 0.57, n = 16, p ≤ 0.05). Such findings suggest that the addition of inspiratory-loaded core conditioning into a high-intensity interval training program augments the influence of the interval program on endurance running performance and that this may be underpinned by an improvement in running economy.

A Xhosa language translation of the CORE-OM using South African university student samples.

PubMed

Campbell, Megan M; Young, Charles

2016-10-01

The translation of well established psychometric tools from English into Xhosa may assist in improving access to psychological services for Xhosa speakers. The aim of this study was to translate the Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM), a measure of general distress and dysfunction developed in the UK, into Xhosa for use at South African university student counselling centres. The CORE-OM and embedded CORE-10 were translated into Xhosa using a five-stage translation design. This design included (a) forward-translation, (b) back-translation, (c) committee approach, (d) qualitative piloting, and (e) quantitative piloting on South African university students. Clinical and general samples were drawn from English-medium South African universities. Clinical samples were generated from university student counselling centres. General student samples were generated through random stratified cluster sampling of full-time university students. Qualitative feedback from the translation process and results from quantitative piloting of the 34-item CORE-OM English and Xhosa versions supported the reduction of the scale to 10 items. This reduced scale is referred to as the South African CORE-10 (SA CORE-10). A measurement and structural model of the SA CORE-10 English version was developed and cross-validated using an English-speaking university student sample. Equivalence of this model with the SA CORE-10 Xhosa version was investigated using a first-language Xhosa-speaking university sample. Partial measurement equivalence was achieved at the metric level. The resultant SA CORE-10 Xhosa and English versions provide core measures of distress and dysfunction. Additional, culture- and language-specific domains could be added to increase sensitivity and specificity. © The Author(s) 2016.

Learning theories and tools for the assessment of core nursing competencies in simulation: A theoretical review.

PubMed

Lavoie, Patrick; Michaud, Cécile; Bélisle, Marilou; Boyer, Louise; Gosselin, Émilie; Grondin, Myrian; Larue, Caroline; Lavoie, Stéphan; Pepin, Jacinthe

2018-02-01

To identify the theories used to explain learning in simulation and to examine how these theories guided the assessment of learning outcomes related to core competencies in undergraduate nursing students. Nurse educators face the challenge of making explicit the outcomes of competency-based education, especially when competencies are conceptualized as holistic and context dependent. Theoretical review. Research papers (N = 182) published between 1999-2015 describing simulation in nursing education. Two members of the research team extracted data from the papers, including theories used to explain how simulation could engender learning and tools used to assess simulation outcomes. Contingency tables were created to examine the associations between theories, outcomes and tools. Some papers (N = 79) did not provide an explicit theory. The 103 remaining papers identified one or more learning or teaching theories; the most frequent were the National League for Nursing/Jeffries Simulation Framework, Kolb's theory of experiential learning and Bandura's social cognitive theory and concept of self-efficacy. Students' perceptions of simulation, knowledge and self-confidence were the most frequently assessed, mainly via scales designed for the study where they were used. Core competencies were mostly assessed with an observational approach. This review highlighted the fact that few studies examined the use of simulation in nursing education through learning theories and via assessment of core competencies. It also identified observational tools used to assess competencies in action, as holistic and context-dependent constructs. © 2017 John Wiley & Sons Ltd.

A review of training research and virtual reality simulators for the da Vinci surgical system.

PubMed

Liu, May; Curet, Myriam

2015-01-01

PHENOMENON: Virtual reality simulators are the subject of several recent studies of skills training for robot-assisted surgery. Yet no consensus exists regarding what a core skill set comprises or how to measure skill performance. Defining a core skill set and relevant metrics would help surgical educators evaluate different simulators. This review draws from published research to propose a core technical skill set for using the da Vinci surgeon console. Publications on three commercial simulators were used to evaluate the simulators' content addressing these skills and associated metrics. An analysis of published research suggests that a core technical skill set for operating the surgeon console includes bimanual wristed manipulation, camera control, master clutching to manage hand position, use of third instrument arm, activating energy sources, appropriate depth perception, and awareness of forces applied by instruments. Validity studies of three commercial virtual reality simulators for robot-assisted surgery suggest that all three have comparable content and metrics. However, none have comprehensive content and metrics for all core skills. INSIGHTS: Virtual reality simulation remains a promising tool to support skill training for robot-assisted surgery, yet existing commercial simulator content is inadequate for performing and assessing a comprehensive basic skill set. The results of this evaluation help identify opportunities and challenges that exist for future developments in virtual reality simulation for robot-assisted surgery. Specifically, the inclusion of educational experts in the development cycle alongside clinical and technological experts is recommended.

High adherence to the ‘Wise List’ treatment recommendations in Stockholm: a 15-year retrospective review of a multifaceted approach promoting rational use of medicines

PubMed Central

Gustafsson, Lars L; Ateva, Kristina; Bastholm-Rahmner, Pia; Ovesjö, Marie-Louise; Jirlow, Malena; Juhasz-Haverinen, Maria; Lärfars, Gerd; Malmström, Rickard E; Wettermark, Björn; Andersén-Karlsson, Eva

2017-01-01

Objectives To present the ‘Wise List’ (a formulary of essential medicines for primary and specialised care in Stockholm Healthcare Region) and assess adherence to the recommendations over a 15-year period. Design Retrospective analysis of all prescription data in the Stockholm Healthcare Region between 2000 and 2015 in relation to the Wise List recommendations during the same time period. Setting All outpatient care in the Stockholm Healthcare Region. Participants All prescribers in the Stockholm Healthcare Region. Main outcome measures The number of core and complementary substances included in the Wise List, the adherence to recommendations by Anatomic Therapeutic Chemical (ATC) 1st level using defined daily doses (DDDs) adjusted to the DDD for 2015, adherence to recommendations over time measured by dispensed prescriptions yearly between 2002 and 2015. Results The number of recommended core substances was stable (175–212). Overall adherence to the recommendations for core medicines for all prescribers increased from 75% to 84% (2000 to 2015). The adherence to recommendations in primary care for core medicines increased from 80% to 90% (2005 to 2015) with decreasing range in practice variation (32% to 13%). Hospital prescriber adherence to core medicine recommendations was stable but increased for the combination core and complementary medicines from 77% to 88% (2007 to 2015). Adherence varied between the 4 therapeutic areas studied. Conclusions High and increasing adherence to the Wise List recommendations was seen for all prescriber categories. The transparent process for developing recommendations involving respected experts and clinicians using strict criteria for handling potential conflicts of interests, feedback to prescribers, continuous medical education and financial incentives are possible contributing factors. High-quality evidence-based recommendations to prescribers, such as the Wise List, disseminated through a multifaceted approach, will become increasingly important and should be developed further to include recommendations and introduction protocols for new expensive medicines. PMID:28465306

Prediction of Core and Lower Extremity Strains and Sprains in Collegiate Football Players: A Preliminary Study

PubMed Central

Wilkerson, Gary B.; Giles, Jessica L.; Seibel, Dustin K.

2012-01-01

Context: Poor core stability is believed to increase vulnerability to uncontrolled joint displacements throughout the kinetic chain between the foot and the lumbar spine. Objective: To assess the value of preparticipation measurements as predictors of core or lower extremity strains or sprains in collegiate football players. Design: Cohort study. Setting: National Collegiate Athletic Association Division I Football Championship Subdivision football program. Patients or Other Participants: All team members who were present for a mandatory physical examination on the day before preseason practice sessions began (n  =  83). Main Outcome Measure(s): Preparticipation administration of surveys to assess low back, knee, and ankle function; documentation of knee and ankle injury history; determination of body mass index; 4 different assessments of core muscle endurance; and measurement of step-test recovery heart rate. All injuries were documented throughout the preseason practice period and 11-game season. Receiver operating characteristic analysis and logistic regression analysis were used to identify dichotomized predictive factors that best discriminated injured from uninjured status. The 75th and 50th percentiles were evaluated as alternative cutpoints for dichotomization of injury predictors. Results: Players with ≥2 of 3 potentially modifiable risk factors related to core function had 2 times greater risk for injury than those with <2 factors (95% confidence interval  =  1.27, 4.22), and adding a high level of exposure to game conditions increased the injury risk to 3 times greater (95% confidence interval  =  1.95, 4.98). Prediction models that used the 75th and 50th percentile cutpoints yielded results that were very similar to those for the model that used receiver operating characteristic-derived cutpoints. Conclusions: Low back dysfunction and suboptimal endurance of the core musculature appear to be important modifiable football injury risk factors that can be identified on preparticipation screening. These predictors need to be assessed in a prospective manner with a larger sample of collegiate football players. PMID:22892407

Health and Functioning of Families of Children With Special Health Care Needs Cared for in Home Care, Long-term Care, and Medical Day Care Settings.

PubMed

Caicedo, Carmen

2015-06-01

To examine and compare child and parent or guardian physical and mental health outcomes in families with children with special health care needs who have medically complex technology-dependent needs in home care, long-term care (LTC), and medical day care (MDC) settings. The number of children requiring medically complex technology-dependent care has grown exponentially. In this study, options for their care are home care, LTC, or MDC. Comparison of child and parent/guardian health outcomes is unknown. Using repeated measures data were collected from 84 dyads (parent/guardian, medically complex technology-dependent child) for 5 months using Pediatric Quality of Life Inventory Generic Core Module 4.0 and Family Impact Module Data analysis: χ(2), RM-ANCOVA. There were no significant differences in overall physical health, mental health, and functioning of children by care setting. Most severely disabled children were in home care; moderately disabled in MDC; children in vegetative state LTC; however, parents perceived children's health across care setting as good to excellent. Parents/guardians from home care reported the poorest physical health including being tired during the day, too tired to do the things they like to do, feeling physically weak, or feeling sick and had cognitive difficulties, difficulties with worry, communication, and daily activities. Parents/guardians from LTC reported the best physical health with time and energy for a social life and employment. Trends in health care policy indicate a movement away from LTC care to care in the family home where data indicate these parents/guardians are already mentally and functionally challenged.

Implementing core NICE guidelines for osteoarthritis in primary care with a model consultation (MOSAICS): a cluster randomised controlled trial.

PubMed

Dziedzic, K S; Healey, E L; Porcheret, M; Afolabi, E K; Lewis, M; Morden, A; Jinks, C; McHugh, G A; Ryan, S; Finney, A; Main, C; Edwards, J J; Paskins, Z; Pushpa-Rajah, A; Hay, E M

2018-01-01

To determine the effectiveness of a model osteoarthritis consultation, compared with usual care, on physical function and uptake of National Institute for Health and Care Excellence (NICE) osteoarthritis recommendations, in adults ≥45 years consulting with peripheral joint pain in UK general practice. Two-arm cluster-randomised controlled trial with baseline health survey. Eight general practices in England. 525 adults ≥45 years consulting for peripheral joint pain, amongst 28,443 population survey recipients. Four intervention practices delivered the model osteoarthritis consultation to patients consulting with peripheral joint pain; four control practices continued usual care. The primary clinical outcome of the trial was the SF-12 physical component score (PCS) at 6 months; the main secondary outcome was uptake of NICE core recommendations by 6 months, measured by osteoarthritis quality indicators. A Linear Mixed Model was used to analyse clinical outcome data (SF-12 PCS). Differences in quality indicator outcomes were assessed using logistic regression. 525 eligible participants were enrolled (mean age 67.3 years, SD 10.5; 59.6% female): 288 from intervention and 237 from control practices. There were no statistically significant differences in SF-12 PCS: mean difference at the 6-month primary endpoint was -0.37 (95% CI -2.32, 1.57). Uptake of core NICE recommendations by 6 months was statistically significantly higher in the intervention arm compared with control: e.g., increased written exercise information, 20.5% (7.9, 28.3). Whilst uptake of core NICE recommendations was increased, there was no evidence of benefit of this intervention, as delivered in this pragmatic randomised trial, on the primary outcome of physical functioning at 6 months. ISRCTN06984617. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

Examining High-Stakes Testing--Forum. "Education Next" Talks with Joshua P. Starr and Margaret Spellings

ERIC Educational Resources Information Center

Starr, Joshua P.; Spellings, Margaret

2014-01-01

More than 40 states plan to assess student performance with new tests tied to the Common Core State Standards. In summer 2013, results from Common Core-aligned tests in New York showed a steep decline in outcomes. Common Core advocates hailed the scores as an honest accounting of school and student performance, while others worried that they…

Dutch Dataset Pain Rehabilitation in daily practice: Content, patient characteristics and reference data.

PubMed

Köke, A J A; Smeets, R J E M; Schreurs, K M; van Baalen, B; de Haan, P; Remerie, S C; Schiphorst Preuper, H R; Reneman, M F

2017-03-01

No core set of measurement tools exists to collect data within clinical practice. Such data could be useful as reference data to guide treatment decisions and to compare patient characteristics or treatment results within specific treatment settings. The Dutch Dataset Pain Rehabilitation was developed which included the six domains of the IMMPACT core set and three new domains relevant in the field of rehabilitation (medical consumption, patient-specific goals and activities/participation). Between 2010 and 2013 the core set was implemented in 32 rehabilitation facilities throughout the Netherlands. A total of 8200 adult patients with chronic pain completed the core set at first consultation with the rehabilitation physician. Adult patients (18-90 years) suffering from a long history of pain (38% >5 years) were referred. Patients had high medical consumption and less than half were working. Although patients were referred with diagnosis of low back pain or neck or shoulder pain, a large group (85%) had multisite pain (39% 2-5 painful body regions; 46% >5 painful body regions). Scores on psychosocial questionnaires were high, indicating high case complexity of referred patients. Reference data for subgroups based on gender, pain severity, pain locations and on pain duration are presented. The data from this clinical core set can be used to compare patient characteristics of patients of other treatment setting and/or scientific publications. As treatment success might depend on case complexity, which is high in the referred patients, the advantages of earlier referral to comprehensive multidisciplinary treatment were discussed. A detailed description of case complexity of patients with chronic pain referred for pain rehabilitation. Insight in case complexity of patients within subgroups on the basis of gender, pain duration, pain severity and pain location. These descriptions can be used as reference data for daily practice in the field of pain rehabilitation and can be used to evaluate, monitor and improve rehabilitation care in care settings nationwide as well as internationally. © 2016 European Pain Federation - EFIC®.

Brief psychosocial education, not core stabilization, reduced incidence of low back pain: results from the Prevention of Low Back Pain in the Military (POLM) cluster randomized trial

PubMed Central

2011-01-01

Background Effective strategies for the primary prevention of low back pain (LBP) remain elusive with few large-scale clinical trials investigating exercise and education approaches. The purpose of this trial was to determine whether core stabilization alone or in combination with psychosocial education prevented incidence of low back pain in comparison to traditional lumbar exercise. Methods The Prevention of Low Back Pain in the Military study was a cluster randomized clinical study with four intervention arms and a two-year follow-up. Participants were recruited from a military training setting from 2007 to 2008. Soldiers in 20 consecutive companies were considered for eligibility (n = 7,616). Of those, 1,741 were ineligible and 1,550 were eligible but refused participation. For the 4,325 Soldiers enrolled with no previous history of LBP average age was 22.0 years (SD = 4.2) and there were 3,082 males (71.3%). Companies were randomly assigned to receive traditional lumbar exercise, traditional lumbar exercise with psychosocial education, core stabilization exercise, or core stabilization with psychosocial education, The psychosocial education session occurred during one session and the exercise programs were done daily for 5 minutes over 12 weeks. The primary outcome for this trial was incidence of low back pain resulting in the seeking of health care. Results There were no adverse events reported. Evaluable patient analysis (4,147/4,325 provided data) indicated no differences in low back incidence resulting in the seeking of health care between those receiving the traditional exercise and core stabilization exercise programs. However, brief psychosocial education prevented low back pain episodes regardless of the assigned exercise approach, resulting in a 3.3% (95% CI: 1.1 to 5.5%) decrease over two years (numbers needed to treat (NNT) = 30.3, 95% CI = 18.2 to 90.9). Conclusions Core stabilization has been advocated as preventative, but offered no such benefit when compared to traditional lumbar exercise in this trial. Instead, a brief psychosocial education program that reduced fear and threat of low back pain decreased incidence of low back pain resulting in the seeking of health care. Since this trial was conducted in a military setting, future studies are necessary to determine if these findings can be translated into civilian populations. Trial Registration NCT00373009 at ClinicalTrials.gov - http://clinicaltrials.gov/ PMID:22126534

Outcome Studies of Social, Behavioral, and Educational Interventions: Emerging Issues and Challenges

ERIC Educational Resources Information Center

Fraser, Mark W.; Guo, Shenyang; Ellis, Alan R.; Thompson, Aaron M.; Wike, Traci L.; Li, Jilan

2011-01-01

This article describes the core features of outcome research and then explores issues confronting researchers who engage in outcome studies. Using an intervention research perspective, descriptive and explanatory methods are distinguished. Emphasis is placed on the counterfactual causal perspective, designing programs that fit culture and context,…

Patient-reported outcomes and adult patients' disease experience in the idiopathic inflammatory myopathies. report from the OMERACT 11 Myositis Special Interest Group.

PubMed

Alexanderson, Helene; Del Grande, Maria; Bingham, Clifton O; Orbai, Ana-Maria; Sarver, Catherine; Clegg-Smith, Katherine; Lundberg, Ingrid E; Song, Yeong Wook; Christopher-Stine, Lisa

2014-03-01

The newly formed Outcome Measures in Rheumatology (OMERACT) Myositis Special Interest Group (SIG) was established to examine patient-reported outcome measures (PROM) in myositis. At OMERACT 11, a literature review of PROM used in the idiopathic inflammatory myopathies (IIM) and other neuromuscular conditions was presented. The group examined in more detail 2 PROM more extensively evaluated in patients with IIM, the Myositis Activities Profile, and the McMaster-Toronto Arthritis Patient Preference Disability Questionnaire, through the OMERACT filter of truth, discrimination, and feasibility. Preliminary results from a qualitative study of patients with myositis regarding their symptoms were discussed that emphasized the range of symptoms experienced: pain, physical tightness/stiffness, fatigue, disease effect on emotional life and relationships, and treatment-related side effects. Following discussion of these results and following additional discussions since OMERACT 11, a research agenda was developed. The next step in evaluating PROM in IIM will require additional focus groups with a spectrum of patients with different myositis disease phenotypes and manifestations across a range of disease activity, and from multiple international settings. The group will initially focus on dermatomyositis and polymyositis in adults. Qualitative analysis will facilitate the identification of commonalities and divergent patient-relevant aspects of disease, insights that are critical given the heterogeneous manifestations of these diseases. Based on these qualitative studies, existing myositis PROM can be examined to more thoroughly assess content validity, and will be important to identify gaps in domain measurement that will be required to develop a preliminary core set of patient-relevant domains for IIM.

Education of eye health professionals to meet the needs of the Pacific.

PubMed

du Toit, Renee; Brian, Garry; Palagyi, Anna; Williams, Carmel; Ramke, Jacqueline

2009-03-13

Vision impairment has significant impact on quality of life and substantial economic consequences. Yet, in the Pacific Islands, as in other low resource settings, it is predominantly caused by chronic conditions that can be treated or prevented. A whole of health approach is required to rectify this, and must include an increase in workforce capacity, both in size and effectiveness, by providing competency-based education for eye care professionals. Training in curative clinical skills is not sufficient: broader competencies--including those for chronic conditions, issues of care quality, integration into the wider health care system, and commitment to professionalism and life-long learning--need to be addressed. Using current best practice approaches in education, and taking into consideration local needs, The Pacific Eye Institute, an initiative of The Fred Hollows Foundation New Zealand, aims to produce graduates with these core competencies who are capable of effectively and acceptably working in community or hospital settings to provide sustainable high quality, comprehensive eye care with ongoing desirable and consistent eye health outcomes.

Veteran Affairs Centers of Excellence in Primary Care Education: transforming nurse practitioner education.

PubMed

Rugen, Kathryn Wirtz; Watts, Sharon A; Janson, Susan L; Angelo, Laura A; Nash, Melanie; Zapatka, Susan A; Brienza, Rebecca; Gilman, Stuart C; Bowen, Judith L; Saxe, JoAnne M

2014-01-01

To integrate health care professional learners into patient-centered primary care delivery models, the Department of Veterans Affairs has funded five Centers of Excellence in Primary Care Education (CoEPCEs). The main goal of the CoEPCEs is to develop and test innovative structural and curricular models that foster transformation of health care training from profession-specific "silos" to interprofessional, team-based educational and care delivery models in patient-centered primary care settings. CoEPCE implementation emphasizes four core curricular domains: shared decision making, sustained relationships, interprofessional collaboration, and performance improvement. The structural models allow interprofessional learners to have longitudinal learning experiences and sustained and continuous relationships with patients, faculty mentors, and peer learners. This article presents an overview of the innovative curricular models developed at each site, focusing on nurse practitioner (NP) education. Insights on transforming NP education in the practice setting and its impact on traditional NP educational models are offered. Preliminary outcomes and sustainment examples are also provided. Published by Mosby, Inc.

Utah State Office of Education Fingertip Facts, 2013-14

ERIC Educational Resources Information Center

Utah State Office of Education, 2014

2014-01-01

Fingertip Facts is a compendium of some of the most frequently requested data sets from the Utah State Office of Education. Data sets in this year's Fingertip Facts include: Core CRT Language Arts Testing, 2013; Core CRT Mathematics Testing, 2013; 2013 Public Education General Fund; 2012-13 Enrollment Demographics; Public Schools by Grade Level,…

Exploring LIS Students' Beliefs in Importance and Self-Efficacy of Core Information Literacy Competencies

ERIC Educational Resources Information Center

Pinto, Maria; Pascual, Rosaura Fernandez

2016-01-01

Understanding perceptions of Library and Information Science (LIS) students on two dimensions--belief in the importance (BIM) of a set of core information competencies, and Self-Efficacy (SE)--is pursued. Factor analysis implementation raises a clear distinction between BIM and SE results. This analysis points to two sets of competencies:…

Slope across the Curriculum: Principles and Standards for School Mathematics and Common Core State Standards

ERIC Educational Resources Information Center

Nagle, Courtney; Moore-Russo, Deborah

2014-01-01

This article provides an initial comparison of the Principles and Standards for School Mathematics and the Common Core State Standards for Mathematics by examining the fundamental notion of slope. Each set of standards is analyzed using eleven previously identified conceptualizations of slope. Both sets of standards emphasize Functional Property,…

A catalog of porosity and permeability from core plugs in siliciclastic rocks

USGS Publications Warehouse

Nelson, Philip H.; Kibler, Joyce E.

2003-01-01

Porosity and permeability measurements on cored samples from siliciclastic formations are presented for 70 data sets, taken from published data and descriptions. Data sets generally represent specific formations, usually from a limited number of wells. Each data set is represented by a written summary, a plot of permeability versus porosity, and a digital file of the data. The summaries include a publication reference, the geologic age of the formation, location, well names, depth range, various geologic descriptions, and core measurement conditions. Attributes such as grain size or depositional environment are identified by symbols on the plots. An index lists the authors and date, geologic age, formation name, sandstone classification, location, basin or structural province, and field name.

The Latent Structure of Dictionaries.

PubMed

Vincent-Lamarre, Philippe; Massé, Alexandre Blondin; Lopes, Marcos; Lord, Mélanie; Marcotte, Odile; Harnad, Stevan

2016-07-01

How many words-and which ones-are sufficient to define all other words? When dictionaries are analyzed as directed graphs with links from defining words to defined words, they reveal a latent structure. Recursively removing all words that are reachable by definition but that do not define any further words reduces the dictionary to a Kernel of about 10% of its size. This is still not the smallest number of words that can define all the rest. About 75% of the Kernel turns out to be its Core, a "Strongly Connected Subset" of words with a definitional path to and from any pair of its words and no word's definition depending on a word outside the set. But the Core cannot define all the rest of the dictionary. The 25% of the Kernel surrounding the Core consists of small strongly connected subsets of words: the Satellites. The size of the smallest set of words that can define all the rest-the graph's "minimum feedback vertex set" or MinSet-is about 1% of the dictionary, about 15% of the Kernel, and part-Core/part-Satellite. But every dictionary has a huge number of MinSets. The Core words are learned earlier, more frequent, and less concrete than the Satellites, which are in turn learned earlier, more frequent, but more concrete than the rest of the Dictionary. In principle, only one MinSet's words would need to be grounded through the sensorimotor capacity to recognize and categorize their referents. In a dual-code sensorimotor/symbolic model of the mental lexicon, the symbolic code could do all the rest through recombinatory definition. Copyright © 2016 Cognitive Science Society, Inc.

A comparison of water-based and land-based core stability exercises in patients with lumbar disc herniation: a pilot study.

PubMed

Bayraktar, Deniz; Guclu-Gunduz, Arzu; Lambeck, Johan; Yazici, Gokhan; Aykol, Sukru; Demirci, Harun

2016-01-01

To determine and compare the effects of core stability exercise programs performed in two different environments in lumbar disc herniation (LDH) patients. Thirty-one patients who were diagnosed with LDH and were experiencing pain or functional disability for at least 3 months were randomly divided into two groups as land-based exercises or water specific therapy. Also, 15 age-sex-matched healthy individuals were recruited as healthy controls. Both groups underwent an 8-week (3 times/week) core stabilization exercise program. Primary outcomes were pain, trunk muscle static endurance and perceived disability level. The secondary outcome was health-related quality of life. Level of static endurance of trunk muscles was found to be lower in the patients compared to the controls at baseline (p < 0.05). Both treatment groups showed significant improvements in all outcomes (p < 0.05) after 8-week intervention. When two treatment groups were compared, no differences were found in the amount of change after the intervention (p > 0.05). After the treatment, static endurance of trunk muscles of the LDH patients became similar to controls (p > 0.05). According to these results, core stabilization exercise training performed on land or in water both could be beneficial in LDH patients and there is no difference between the environments. An 8-week core stabilization program performed in water or on land decrease pain level and improve functional status in LDH patients. Both programs seem beneficial to increase health-related quality of life and static endurance of trunk muscles. Core stability exercises could be performed in water as well, no differences were found between methods due to environment.

Catheter placement for lysis of spontaneous intracerebral hematomas: does a catheter position in the core of the hematoma allow more effective and faster hematoma lysis?

PubMed

Malinova, Vesna; Schlegel, Anna; Rohde, Veit; Mielke, Dorothee

2017-07-01

For the fibrinolytic therapy of intracerebral hematomas (ICH) using recombinant tissue plasminogen activator (rtPA), a catheter position in the core of the hematoma along the largest clot diameter was assumed to be optimal for an effective clot lysis. However, it never had been proven that core position indeed enhances clot lysis if compared with less optimal catheter positions. In this study, the impact of the catheter position on the effectiveness and on the time course of clot lysis was evaluated. We analyzed the catheter position using a relative error calculating the distance perpendicular to the catheter's center in relation to hematoma's diameter and evaluated the relative hematoma volume reduction (RVR). The correlation of the RVR with the catheter position was evaluated. Additionally, we tried to identify patterns of clot lysis with different catheter positions. The patient's outcome at discharge was evaluated using the Glasgow outcome score. A total of 105 patients were included in the study. The mean hematoma volume was 56 ml. The overall RVR was 62.7 %. In 69 patients, a catheter position in the core of the clot was achieved. We found no significant correlation between catheter position and hematoma RVR (linear regression, p = 0.14). Core catheter position leads to more symmetrical hematoma RVR. Faster clot lysis happens in the vicinity of the catheter openings. We found no significant difference in the patient's outcome dependent on the catheter position (linear regression, p = 0.90). The catheter position in the core of the hematoma along its largest diameter does not significantly influence the effectiveness of clot lysis after rtPA application.

High-dose diazepam facilitates core cooling during cold saline infusion in healthy volunteers.

PubMed

Hostler, David; Northington, William E; Callaway, Clifton W

2009-08-01

Studies have suggested that inducing mild hypothermia improves neurologic outcomes after traumatic brain injury, major stroke, cardiac arrest, or exertional heat illness. While infusion of cold normal saline is a simple and inexpensive method for reducing core temperature, human cold-defense mechanisms potentially make this route stressful or ineffective. We hypothesized that intravenous administration of diazepam during a rapid infusion of 30 mL.kg-1 of cold (4 degrees C) 0.9% saline to healthy subjects would be more comfortable and reduce core body temperature more than the administration of cold saline alone. Fifteen subjects received rapidly infused cold (4 degrees C) 0.9% saline. Subjects were randomly assigned to receive, intravenously, 20 mg diazepam (HIGH), 10 mg diazepam (LOW), or placebo (CON). Main outcomes were core temperature, skin temperature, and oxygen consumption. Data for the main outcomes were analyzed with generalized estimating equations to identify differences in group, time, or a group x time interaction. Core temperature decreased in all groups (CON, 1.0 +/- 0.2 degrees C; LOW, 1.4 +/- 0.2 degrees C; HIGH, 1.5 +/- 0.2 degrees C), while skin temperature was unchanged. Mean (95% CI) oxygen consumption was 315.3 (253.8, 376.9) mL.kg-1.min-1 in the CON group, 317.9 (275.5, 360.3) in the LOW group, and 226.1 (216.4, 235.9) in the HIGH group. Significant time and group x time interaction was observed for core temperature and oxygen consumption (p < 0.001). Administration of high-dose diazepam resulted in decreased oxygen consumption during cold saline infusion, suggesting that 20 mg of intravenous diazepam may reduce the shivering threshold without compromising respiratory or cardiovascular function.

Acute viral bronchiolitis: Physician perspectives on definition and clinically important outcomes.

PubMed

Fernandes, Ricardo M; Andrade, Maria Gabriela; Constant, Carolina; Malveiro, Duarte; Magalhães, Manuel; Abreu, Daisy; Azevedo, Inês; Sousa, Eduarda; Salgado, Rizério; Bandeira, Teresa

2016-07-01

Two key limitations hamper intervention research in bronchiolitis: the absence of a clear definition of disease, and the heterogeneous choice of outcome measures in current clinical trials. We assessed how paediatricians and general practitioners (GPs) perceived definition and clinically important outcomes in bronchiolitis. A nationwide online survey (ABBA study) was conducted through the Portuguese Society of Paediatrics and GPs' mailing lists. We assessed agreement with statements on bronchiolitis definition, and participants were asked to score the relative importance of several outcomes. Principal component analysis (PCA) explored dimensions underlying disease definition. Outcomes were ranked by mean score and proportion given highest score. We included 514 paediatricians and 165 GPs (overall 59% were board-certified). Most paediatricians (76.5%) agreed with a definition based on coryza, wheezing and/or crackles/rales, compared to 38.1% GPs (P < 0.001). Less than 5% physicians agreed with a definition commonly used in clinical trials (<12 months, first episode of wheeze). We retained three dimensions on PCA: one based on coryza, rales/crepitations and no sudden onset; another on number of episodes and age; and a third on wheeze. Dimensions varied by physician specialization and training (P < 0.01). Hospital admission and respiratory distress were top rated outcomes by both groups of physicians. Physician definitions of bronchiolitis have considerable variability and often mismatch those of clinical trials. Rating of important outcomes was consistent. Our results highlight the need for a robust standardized definition of acute bronchiolitis in infants and support the development of a core outcome set for future clinical trials. Pediatr Pulmonol. 2016;51:724-732. © 2015 Wiley Periodicals, Inc. © 2015 Wiley Periodicals, Inc.

Reporting clinical outcomes of breast reconstruction: a systematic review.

PubMed

Potter, S; Brigic, A; Whiting, P F; Cawthorn, S J; Avery, K N L; Donovan, J L; Blazeby, J M

2011-01-05

Breast reconstruction after mastectomy for cancer requires accurate evaluation to inform evidence-based participatory decision making, but the standards of outcome reporting after breast reconstruction have not previously been considered. We used extensive searches to identify articles reporting surgical outcomes of breast reconstruction. We extracted data using published criteria for complication reporting modified to reflect reconstructive practice. Study designs included randomized controlled trials, cohort studies, and case series. The Cochrane Risk of Bias tool was used to critically appraise all study designs. Other criteria used to assess the studies were selection and funding bias, statistical power calculations, and institutional review board approval. Wilcoxon signed rank tests were used to compare the breadth and frequency of study outcomes, and χ² tests were used to compare the number of studies in each group reporting each of the published criteria. All statistical tests were two-sided. Surgical complications following breast reconstruction in 42,146 women were evaluated in 134 studies. These included 11 (8.2%) randomized trials, 74 (55.2%) cohort studies, and 49 (36.6%) case series. Fifty-three percent of studies demonstrated a disparity between methods and results in the numbers of complications reported. Complications were defined by 87 (64.9%) studies and graded by 78 (58.2%). Details such as the duration of follow-up and risk factors for adverse outcomes were omitted from 47 (35.1%) and 58 (43.3%) studies, respectively. Overall, the studies defined fewer than 20% of the complications they reported, and the definitions were largely inconsistent. The results of this systematic review suggest that outcome reporting in breast reconstruction is inconsistent and lacks methodological rigor. The development of a standardized core outcome set is recommended to improve outcome reporting in breast reconstruction.

A model to advance nursing science in trauma practice and injury outcomes research.

PubMed

Richmond, Therese S; Aitken, Leanne M

2011-12-01

This discussion paper reports development of a model to advance nursing science and practice in trauma care based on an analysis of the literature and expert opinion. The continuum of clinical care provided to trauma patients extends from the time of injury through to long-term recovery and final outcomes. Nurses bring a unique expertise to meet the complex physical and psychosocial needs of trauma patients and their families to influence outcomes across this entire continuum. Literature was obtained by searching CINAHL, PubMed and OvidMedline databases for 1990-2010. Search terms included trauma, nursing, scope of practice and role, with results restricted to those published in English. Manual searches of relevant journals and websites were undertaken. Core concepts in this trauma outcomes model include environment, person/family, structured care settings, long-term outcomes and nursing interventions. The relationships between each of these concepts extend across all phases of care. Intermediate outcomes are achieved in each phase of care and influence and have congruence with long-term outcomes. Implications for policy and practice.  This model is intended to provide a framework to assist trauma nurses and researchers to consider the injured person in the context of the social, economic, cultural and physical environment from which they come and the long-term goals that each person has during recovery. The entire model requires testing in research and assessment of its practical contribution to practice. Planning and integrating care across the trauma continuum and recognition of the role of the injured person's background, family and resources will lead to improved long-term outcomes. © 2011 Blackwell Publishing Ltd.

Using claims data to examine mortality trends following hospitalization for heart attack in Medicare.

PubMed

Ash, Arlene S; Posner, Michael A; Speckman, Jeanne; Franco, Shakira; Yacht, Andrew C; Bramwell, Lindsey

2003-10-01

To see if changes in the demographics and illness burden of Medicare patients hospitalized for acute myocardial infarction (AMI) from 1995 through 1999 can explain an observed rise (from 32 percent to 34 percent) in one-year mortality over that period. Utilization data from the Centers for Medicare and Medicaid Services (CMS) fee-for-service claims (MedPAR, Outpatient, and Carrier Standard Analytic Files); patient demographics and date of death from CMS Denominator and Vital Status files. For over 1.5 million AMI discharges in 1995-1999 we retain diagnoses from one year prior, and during, the case-defining admission. We fit logistic regression models to predict one-year mortality for the 1995 cases and apply them to 1996-1999 files. The CORE model uses age, sex, and original reason for Medicare entitlement to predict mortality. Three other models use the CORE variables plus morbidity indicators from well-known morbidity classification methods (Charlson, DCG, and AHRQ's CCS). Regressions were used as is--without pruning to eliminate clinical or statistical anomalies. Each model references the same diagnoses--those recorded during the pre- and index admission periods. We compare each model's ability to predict mortality and use each to calculate risk-adjusted mortality in 1996-1999. The comprehensive morbidity classifications (DCG and CCS) led to more accurate predictions than the Charlson, which dominated the CORE model (validated C-statistics: 0.81, 0.82, 0.74, and 0.66, respectively). Using the CORE model for risk adjustment reduced, but did not eliminate, the mortality increase. In contrast, adjustment using any of the morbidity models produced essentially flat graphs. Prediction models based on claims-derived demographics and morbidity profiles can be extremely accurate. While one-year post-AMI mortality in Medicare may not be worsening, outcomes appear not to have continued to improve as they had in the prior decade. Rich morbidity information is available in claims data, especially when longitudinally tracked across multiple settings of care, and is important in setting performance targets and evaluating trends.

Using Claims Data to Examine Mortality Trends Following Hospitalization for Heart Attack in Medicare

PubMed Central

Ash, Arlene S; Posner, Michael A; Speckman, Jeanne; Franco, Shakira; Yacht, Andrew C; Bramwell, Lindsey

2003-01-01

Objective To see if changes in the demographics and illness burden of Medicare patients hospitalized for acute myocardial infarction (AMI) from 1995 through 1999 can explain an observed rise (from 32 percent to 34 percent) in one-year mortality over that period. Data Sources Utilization data from the Centers for Medicare and Medicaid Services (CMS) fee-for-service claims (MedPAR, Outpatient, and Carrier Standard Analytic Files); patient demographics and date of death from CMS Denominator and Vital Status files. For over 1.5 million AMI discharges in 1995–1999 we retain diagnoses from one year prior, and during, the case-defining admission. Study Design We fit logistic regression models to predict one-year mortality for the 1995 cases and apply them to 1996–1999 files. The CORE model uses age, sex, and original reason for Medicare entitlement to predict mortality. Three other models use the CORE variables plus morbidity indicators from well-known morbidity classification methods (Charlson, DCG, and AHRQ's CCS). Regressions were used as is—without pruning to eliminate clinical or statistical anomalies. Each model references the same diagnoses—those recorded during the pre- and index admission periods. We compare each model's ability to predict mortality and use each to calculate risk-adjusted mortality in 1996–1999. Principal Findings The comprehensive morbidity classifications (DCG and CCS) led to more accurate predictions than the Charlson, which dominated the CORE model (validated C-statistics: 0.81, 0.82, 0.74, and 0.66, respectively). Using the CORE model for risk adjustment reduced, but did not eliminate, the mortality increase. In contrast, adjustment using any of the morbidity models produced essentially flat graphs. Conclusions Prediction models based on claims-derived demographics and morbidity profiles can be extremely accurate. While one-year post-AMI mortality in Medicare may not be worsening, outcomes appear not to have continued to improve as they had in the prior decade. Rich morbidity information is available in claims data, especially when longitudinally tracked across multiple settings of care, and is important in setting performance targets and evaluating trends. PMID:14596389

Comparability of outcome frameworks in medical education: Implications for framework development.

PubMed

Hautz, Stefanie C; Hautz, Wolf E; Feufel, Markus A; Spies, Claudia D

2015-01-01

Given the increasing mobility of medical students and practitioners, there is a growing need for harmonization of medical education and qualifications. Although several initiatives have sought to compare national outcome frameworks, this task has proven a challenge. Drawing on an analysis of existing outcome frameworks, we identify factors that hinder comparability and suggest ways of facilitating comparability during framework development and revisions. We searched MedLine, EmBase and the Internet for outcome frameworks in medical education published by national or governmental organizations. We analyzed these frameworks for differences and similarities that influence comparability. Of 1816 search results, 13 outcome frameworks met our inclusion criteria. These frameworks differ in five core features: history and origins, formal structure, medical education system, target audience and key terms. Many frameworks reference other frameworks without acknowledging these differences. Importantly, the level of detail of the outcomes specified differs both within and between frameworks. The differences identified explain some of the challenges involved in comparing outcome frameworks and medical qualifications. We propose a two-level model distinguishing between "core" competencies and culture-specific "secondary" competencies. This approach could strike a balance between local specifics and cross-national comparability of outcome frameworks and medical education.

Magnetic resonance imaging in Alzheimer's Disease Neuroimaging Initiative 2.

PubMed

Jack, Clifford R; Barnes, Josephine; Bernstein, Matt A; Borowski, Bret J; Brewer, James; Clegg, Shona; Dale, Anders M; Carmichael, Owen; Ching, Christopher; DeCarli, Charles; Desikan, Rahul S; Fennema-Notestine, Christine; Fjell, Anders M; Fletcher, Evan; Fox, Nick C; Gunter, Jeff; Gutman, Boris A; Holland, Dominic; Hua, Xue; Insel, Philip; Kantarci, Kejal; Killiany, Ron J; Krueger, Gunnar; Leung, Kelvin K; Mackin, Scott; Maillard, Pauline; Malone, Ian B; Mattsson, Niklas; McEvoy, Linda; Modat, Marc; Mueller, Susanne; Nosheny, Rachel; Ourselin, Sebastien; Schuff, Norbert; Senjem, Matthew L; Simonson, Alix; Thompson, Paul M; Rettmann, Dan; Vemuri, Prashanthi; Walhovd, Kristine; Zhao, Yansong; Zuk, Samantha; Weiner, Michael

2015-07-01

Alzheimer's Disease Neuroimaging Initiative (ADNI) is now in its 10th year. The primary objective of the magnetic resonance imaging (MRI) core of ADNI has been to improve methods for clinical trials in Alzheimer's disease (AD) and related disorders. We review the contributions of the MRI core from present and past cycles of ADNI (ADNI-1, -Grand Opportunity and -2). We also review plans for the future-ADNI-3. Contributions of the MRI core include creating standardized acquisition protocols and quality control methods; examining the effect of technical features of image acquisition and analysis on outcome metrics; deriving sample size estimates for future trials based on those outcomes; and piloting the potential utility of MR perfusion, diffusion, and functional connectivity measures in multicenter clinical trials. Over the past decade the MRI core of ADNI has fulfilled its mandate of improving methods for clinical trials in AD and will continue to do so in the future. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Implementation fidelity trajectories of a health promotion program in multidisciplinary settings: managing tensions in rehabilitation care.

PubMed

Hoekstra, Femke; van Offenbeek, Marjolein A G; Dekker, Rienk; Hettinga, Florentina J; Hoekstra, Trynke; van der Woude, Lucas H V; van der Schans, Cees P

2017-12-01

Although the importance of evaluating implementation fidelity is acknowledged, little is known about heterogeneity in fidelity over time. This study aims to generate insight into the heterogeneity in implementation fidelity trajectories of a health promotion program in multidisciplinary settings and the relationship with changes in patients' health behavior. This study used longitudinal data from the nationwide implementation of an evidence-informed physical activity promotion program in Dutch rehabilitation care. Fidelity scores were calculated based on annual surveys filled in by involved professionals (n = ± 70). Higher fidelity scores indicate a more complete implementation of the program's core components. A hierarchical cluster analysis was conducted on the implementation fidelity scores of 17 organizations at three different time points. Quantitative and qualitative data were used to explore organizational and professional differences between identified trajectories. Regression analyses were conducted to determine differences in patient outcomes. Three trajectories were identified as the following: 'stable high fidelity' (n = 9), 'moderate and improving fidelity' (n = 6), and 'unstable fidelity' (n = 2). The stable high fidelity organizations were generally smaller, started earlier, and implemented the program in a more structured way compared to moderate and improving fidelity organizations. At the implementation period's start and end, support from physicians and physiotherapists, professionals' appreciation, and program compatibility were rated more positively by professionals working in stable high fidelity organizations as compared to the moderate and improving fidelity organizations (p < .05). Qualitative data showed that the stable high fidelity organizations had often an explicit vision and strategy about the implementation of the program. Intriguingly, the trajectories were not associated with patients' self-reported physical activity outcomes (adjusted model β = - 651.6, t(613) = - 1032, p = .303). Differences in organizational-level implementation fidelity trajectories did not result in outcome differences at patient-level. This suggests that an effective implementation fidelity trajectory is contingent on the local organization's conditions. More specifically, achieving stable high implementation fidelity required the management of tensions: realizing a localized change vision, while safeguarding the program's standardized core components and engaging the scarce physicians throughout the process. When scaling up evidence-informed health promotion programs, we propose to tailor the management of implementation tensions to local organizations' starting position, size, and circumstances. The Netherlands National Trial Register NTR3961 . Registered 18 April 2013.

EDITSPEC: System Manual. Volume IV. Data Handler.

DTIC Science & Technology

1980-11-01

PRINTS AND ABORTS OR RETURNS WITHOUT SAYING ANYTHING DKFBF FILL BUFFER ROUTINE: BT ENTRY AT IBTAD IS IN D GET BLOCK NBL OF DATA SET NSW IN AND WAIT FOR...READ COMPLETION DKFND ROUTINE TO LOCATE BLOCK NBL SEGMENT NSG OF DATA SET NSW. N SEARCHES BT’S FIRST’THEN READS INTO CORE RETURNS IBTAD=THE BT ENTRY...WHICH IS RETURNED IN NBL . DKMIC ROUTINE TO SEARCH IN CORE BUFFER TABLES FOR ONE WITH DATA SET NOS FILENAME FILNM AND RETURN THE ONE WITH THE MOST

Profound Interfacial Effects in CoFe2O4/Fe3O4 and Fe3O4/CoFe2O4 Core/Shell Nanoparticles

NASA Astrophysics Data System (ADS)

Polishchuk, Dmytro; Nedelko, Natalia; Solopan, Sergii; Ślawska-Waniewska, Anna; Zamorskyi, Vladyslav; Tovstolytkin, Alexandr; Belous, Anatolii

2018-03-01

Two sets of core/shell magnetic nanoparticles, CoFe2O4/Fe3O4 and Fe3O4/CoFe2O4, with a fixed diameter of the core ( 4.1 and 6.3 nm for the former and latter sets, respectively) and thickness of shells up to 2.5 nm were synthesized from metal chlorides in a diethylene glycol solution. The nanoparticles were characterized by X-ray diffraction, transmission electron microscopy, and magnetic measurements. The analysis of the results of magnetic measurements shows that coating of magnetic nanoparticles with the shells results in two simultaneous effects: first, it modifies the parameters of the core-shell interface, and second, it makes the particles acquire combined features of the core and the shell. The first effect becomes especially prominent when the parameters of core and shell strongly differ from each other. The results obtained are useful for optimizing and tailoring the parameters of core/shell spinel ferrite magnetic nanoparticles for their use in various technological and biomedical applications.

Teaching clinical skills in developing countries: are clinical skills centres the answer?

PubMed

Stark, Patsy; Fortune, F

2003-11-01

There is growing international interest in teaching clinical skills in a variety of contexts, one of which is Clinical Skills Centres. The drivers for change making Skills Centres an important adjunct to ward and ambulatory teaching come both from within and outside medical education. Educationally, self-directed learning is becoming the accepted norm, encouraging students to seek and maximize learning opportunities. There are global changes in health care practice, increased consumerism and increasing student numbers. In some countries, professional recommendations influence what is taught. Increasingly, core skills curricula and outcome objectives are being defined. This explicit definition encourages assessment of the core skills. In turn, all students require equal opportunities to learn how to practise the skills safely and competently. The moves towards interprofessional education make joint learning in a"neutral" setting, like a Clinical Skills Centre, appear particularly attractive. To discuss the potential role of Clinical Skills Centres in skills training in developing countries and to consider alternative options. Many developing countries seek to establish Clinical Skills Centres to ensure effective and reliable skills teaching. However, the model may not be appropriate,because fully equipped Clinical Skills Centres are expensive to set up, staff; and run. They are not the only way to achieve high quality clinical teaching. Suggested options are based on the philosophy and teaching methods successfully developed in Clinical Skills Centres that may fulfil the local needs to achieve low cost and high quality clinical teaching which is reflective of the local health needs and cultural expectations.

Project ACHIEVE - using implementation research to guide the evaluation of transitional care effectiveness.

PubMed

Li, Jing; Brock, Jane; Jack, Brian; Mittman, Brian; Naylor, Mary; Sorra, Joanna; Mays, Glen; Williams, Mark V

2016-02-19

Poorly managed hospital discharges and care transitions between health care facilities can cause poor outcomes for both patients and their caregivers. Unfortunately, the usual approach to health care delivery does not support continuity and coordination across the settings of hospital, doctors' offices, home or nursing homes. Though complex efforts with multiple components can improve patient outcomes and reduce 30-day readmissions, research has not identified which components are necessary. Also we do not know how delivery of core components may need to be adjusted based on patient, caregiver, setting or characteristics of the community, or how system redesign can be accelerated. Project ACHIEVE focuses on diverse Medicare populations such as individuals with multiple chronic diseases, patients with low health literacy/numeracy and limited English proficiency, racial and ethnic minority groups, low-income groups, residents of rural areas, and individuals with disabilities. During the first phase, we will use focus groups to identify the transitional care outcomes and components that matter most to patients and caregivers to inform development and validation of assessment instruments. During the second phase, we will evaluate the comparative effectiveness of multi-component care transitions programs occurring across the U.S. Using a mixed-methods approach for this evaluation, we will study historical (retrospective) and current and future (prospective) groups of patients, caregivers and providers using site visits, surveys, and clinical and claims data. In this natural experiment observational study, we use a fractional factorial study design to specify comparators and estimate the individual and combined effects of key transitional care components. Our study will determine which evidence-based transitional care components and/or clusters most effectively produce patient and caregiver desired outcomes overall and among diverse patient and caregiver populations in different healthcare settings. Using the results, we will develop concrete, actionable recommendations regarding how best to implement these strategies. Finally, this work will provide tools for hospitals, community-based organizations, patients, caregivers, clinicians and other stakeholders to help them make informed decisions about which strategies are most effective and how best to implement them in their communities. Registered as NCT02354482 on clinicaltrials.gov on 1/29/2015.

Drug-resistant tuberculosis clinical trials: proposed core research definitions in adults.

PubMed

Furin, J; Alirol, E; Allen, E; Fielding, K; Merle, C; Abubakar, I; Andersen, J; Davies, G; Dheda, K; Diacon, A; Dooley, K E; Dravnice, G; Eisenach, K; Everitt, D; Ferstenberg, D; Goolam-Mahomed, A; Grobusch, M P; Gupta, R; Harausz, E; Harrington, M; Horsburgh, C R; Lienhardt, C; McNeeley, D; Mitnick, C D; Nachman, S; Nahid, P; Nunn, A J; Phillips, P; Rodriguez, C; Shah, S; Wells, C; Thomas-Nyang'wa, B; du Cros, P

2016-03-01

Drug-resistant tuberculosis (DR-TB) is a growing public health problem, and for the first time in decades, new drugs for the treatment of this disease have been developed. These new drugs have prompted strengthened efforts in DR-TB clinical trials research, and there are now multiple ongoing and planned DR-TB clinical trials. To facilitate comparability and maximise policy impact, a common set of core research definitions is needed, and this paper presents a core set of efficacy and safety definitions as well as other important considerations in DR-TB clinical trials work. To elaborate these definitions, a search of clinical trials registries, published manuscripts and conference proceedings was undertaken to identify groups conducting trials of new regimens for the treatment of DR-TB. Individuals from these groups developed the core set of definitions presented here. Further work is needed to validate and assess the utility of these definitions but they represent an important first step to ensure there is comparability in clinical trials on multidrug-resistant TB.

[The International Classification of Functioning, Disability and Health (ICF) : The implementation of the ICF Core Sets for Hand Conditions in clinical routine as an example of application].

PubMed

Coenen, Michaela; Rudolf, Klaus-Dieter; Kus, Sandra; Dereskewitz, Caroline

2018-05-24

The International Classification of Functioning, Disability and Health (ICF) provides a standardized language of almost 1500 ICF categories for coding information about functioning and contextual factors. Short lists (ICF Core Sets) are helpful tools to support the implementation of the ICF in clinical routine. In this paper we report on the implementation of ICF Core Sets in clinical routine using the "ICF Core Sets for Hand Conditions" and the "Lighthouse Project Hand" as an example. Based on the ICF categories of the "Brief ICF Core Set for Hand Conditions", the ICF-based assessment tool (ICF Hand A ) was developed aiming to guide the assessment and treatment of patients with injuries and diseases located at the hand. The ICF Hand A facilitates the standardized assessment of functioning - taking into consideration of a holistic view of the patients - along the continuum of care ranging from acute care to rehabilitation and return to work. Reference points for the assessment of the ICF Hand A are determined in treatment guidelines for selected injuries and diseases of the hand along with recommendations for acute treatment and care, procedures and interventions of subsequent treatment and rehabilitation. The assessment of the ICF Hand A according to the defined reference points can be done using electronic clinical assessment tools and allows for an automatic generation of a timely medical report of a patient's functioning. In the future, the ICF Hand A can be used to inform the coding of functioning in ICD-11.

Development of outcome measures for large-vessel vasculitis for use in clinical trials: opportunities, challenges, and research agenda.

PubMed

Direskeneli, Haner; Aydin, Sibel Z; Kermani, Tanaz A; Matteson, Eric L; Boers, Maarten; Herlyn, Karen; Luqmani, Raashid A; Neogi, Tuhina; Seo, Philip; Suppiah, Ravi; Tomasson, Gunnar; Merkel, Peter A

2011-07-01

Giant cell (GCA) and Takayasu's arteritis (TAK) are 2 forms of large-vessel vasculitis (LVV) that involve the aorta and its major branches. GCA has a predilection for the cranial branches, while TAK tends to affect the extracranial branches. Both disorders may also cause nonspecific constitutional symptoms. Although some clinical features are more common in one or the other disorder and the ages of initial presentation differ substantially, there is enough clinical and histopathologic overlap between these disorders that some investigators suggest GCA and TAK may be 2 processes within the spectrum of a single disease. There have been few randomized therapeutic trials completed in GCA, and none in TAK. The lack of therapeutic trials in LVV is only partially explained by the rarity of these diseases. It is likely that the lack of well validated outcome measures for LVV and uncertainties regarding trial design contribute to the paucity of trials for these diseases. An initiative to develop a core set of outcome measures for use in clinical trials of LVV was launched by the international OMERACT Vasculitis Working Group in 2009 and subsequently endorsed by the OMERACT community at the OMERACT 10 meeting. Aims of this initiative include: (1) to review the literature and existing data related to outcome assessments in LVV; (2) to obtain the opinion of experts and patients on disease content; and (3) to formulate a research agenda to facilitate a more data-based approach to outcomes development.

Development of Outcome Measures for Large-vessel Vasculitis for Use in Clinical Trials: Opportunities, Challenges, and Research Agenda

PubMed Central

DIRESKENELI, HANER; AYDIN, SIBEL Z.; KERMANI, TANAZ A.; MATTESON, ERIC L.; BOERS, MAARTEN; HERLYN, KAREN; LUQMANI, RAASHID A.; NEOGI, TUHINA; SEO, PHILIP; SUPPIAH, RAVI; TOMASSON, GUNNAR; MERKEL, PETER A.

2013-01-01

Giant cell (GCA) and Takayasu’s arteritis (TAK) are 2 forms of large-vessel vasculitis (LVV) that involve the aorta and its major branches. GCA has a predilection for the cranial branches, while TAK tends to affect the extracranial branches. Both disorders may also cause nonspecific constitutional symptoms. Although some clinical features are more common in one or the other disorder and the ages of initial presentation differ substantially, there is enough clinical and histopathologic overlap between these disorders that some investigators suggest GCA and TAK may be 2 processes within the spectrum of a single disease. There have been few randomized therapeutic trials completed in GCA, and none in TAK. The lack of therapeutic trials in LVV is only partially explained by the rarity of these diseases. It is likely that the lack of well validated outcome measures for LVV and uncertainties regarding trial design contribute to the paucity of trials for these diseases. An initiative to develop a core set of outcome measures for use in clinical trials of LVV was launched by the international OMERACT Vasculitis Working Group in 2009 and subsequently endorsed by the OMERACT community at the OMERACT 10 meeting. Aims of this initiative include: (1) to review the literature and existing data related to outcome assessments in LVV; (2) to obtain the opinion of experts and patients on disease content; and (3) to formulate a research agenda to facilitate a more data-based approach to outcomes development. PMID:21724719

Preventing and De-escalating Aggressive Behavior Among Adult Psychiatric Patients: A Systematic Review of the Evidence.

PubMed

Gaynes, Bradley N; Brown, Carrie L; Lux, Linda J; Brownley, Kimberly A; Van Dorn, Richard A; Edlund, Mark J; Coker-Schwimmer, Emmanuel; Weber, Rachel Palmieri; Sheitman, Brian; Zarzar, Theodore; Viswanathan, Meera; Lohr, Kathleen N

2017-08-01

The project goal was to compare the effectiveness of strategies to prevent and de-escalate aggressive behaviors among psychiatric patients in acute care settings, including interventions for reducing use of seclusion and restraint. Relevant databases were systematically reviewed for comparative studies of violence prevention and de-escalation strategies involving adult psychiatric patients in acute care settings. Studies (trials and cohort studies) were required to report on aggression or seclusion or restraint outcomes. Both risk of bias, an indicator of quality of individual studies, and strength of evidence (SOE) for each outcome were independently assessed by two study personnel. Seventeen primary studies met inclusion criteria. Evidence was limited for benefits and harms; information about characteristics that might modify the interventions' effectiveness, such as race or ethnicity, was especially limited. All but one study had a medium or high risk of bias and thus presented worrisome limitations. For prevention, risk assessment reduced both aggression and use of seclusion and restraint (low SOE), and multimodal interventions reduced the use of seclusion and restraint (low SOE). SOE for all other interventions, whether aimed at preventing or de-escalating aggression, and for modifying characteristics was insufficient. Available evidence about strategies for preventing and de-escalating aggressive behavior among psychiatric patients is very limited. Two preventive strategies, risk assessment and multimodal interventions consistent with the Six Core Strategies principles, may effectively lower aggressive behavior and use of seclusion and restraint, but more research is needed on how best to prevent and de-escalate aggressive behavior in acute care settings.

Patient- and family-centered care coordination: a framework for integrating care for children and youth across multiple systems.

PubMed

2014-05-01

Understanding a care coordination framework, its functions, and its effects on children and families is critical for patients and families themselves, as well as for pediatricians, pediatric medical subspecialists/surgical specialists, and anyone providing services to children and families. Care coordination is an essential element of a transformed American health care delivery system that emphasizes optimal quality and cost outcomes, addresses family-centered care, and calls for partnership across various settings and communities. High-quality, cost-effective health care requires that the delivery system include elements for the provision of services supporting the coordination of care across settings and professionals. This requirement of supporting coordination of care is generally true for health systems providing care for all children and youth but especially for those with special health care needs. At the foundation of an efficient and effective system of care delivery is the patient-/family-centered medical home. From its inception, the medical home has had care coordination as a core element. In general, optimal outcomes for children and youth, especially those with special health care needs, require interfacing among multiple care systems and individuals, including the following: medical, social, and behavioral professionals; the educational system; payers; medical equipment providers; home care agencies; advocacy groups; needed supportive therapies/services; and families. Coordination of care across settings permits an integration of services that is centered on the comprehensive needs of the patient and family, leading to decreased health care costs, reduction in fragmented care, and improvement in the patient/family experience of care. Copyright © 2014 by the American Academy of Pediatrics.

Identifying Common Practice Elements to Improve Social, Emotional, and Behavioral Outcomes of Young Children in Early Childhood Classrooms.

PubMed

McLeod, Bryce D; Sutherland, Kevin S; Martinez, Ruben G; Conroy, Maureen A; Snyder, Patricia A; Southam-Gerow, Michael A

2017-02-01

Educators are increasingly being encouraged to implement evidence-based interventions and practices to address the social, emotional, and behavioral needs of young children who exhibit problem behavior in early childhood settings. Given the nature of social-emotional learning during the early childhood years and the lack of a common set of core evidence-based practices within the early childhood literature, selection of instructional practices that foster positive social, emotional, and behavioral outcomes for children in early childhood settings can be difficult. The purpose of this paper is to report findings from a study designed to identify common practice elements found in comprehensive intervention models (i.e., manualized interventions that include a number of components) or discrete practices (i.e., a specific behavior or action) designed to target social, emotional, and behavioral learning of young children who exhibit problem behavior. We conducted a systematic review of early childhood classroom interventions that had been evaluated in randomized group designs, quasi-experimental designs, and single-case experimental designs. A total of 49 published articles were identified, and an iterative process was used to identify common practice elements. The practice elements were subsequently reviewed by experts in social-emotional and behavioral interventions for young children. Twenty-four practice elements were identified and classified into content (the goal or general principle that guides a practice element) and delivery (the way in which a teacher provides instruction to the child) categories. We discuss implications that the identification of these practice elements found in the early childhood literature has for efforts to implement models and practices.

Low Back Pain in 17 Countries, a Rasch Analysis of the ICF Core Set for Low Back Pain

ERIC Educational Resources Information Center

Roe, Cecilie; Bautz-Holter, Erik; Cieza, Alarcos

2013-01-01

Previous studies indicate that a worldwide measurement tool may be developed based on the International Classification of Functioning Disability and Health (ICF) Core Sets for chronic conditions. The aim of the present study was to explore the possibility of constructing a cross-cultural measurement of functioning for patients with low back pain…

Permeability-porosity data sets for sandstones

USGS Publications Warehouse

Nelson, P.H.

2004-01-01

Due to the variable nature of permeability-porosity relations, core should be obtained and permeability (k) and porosity (??) should be determined on core plugs in the laboratory for the formation of interest. A catalog of k versus (??) data sets is now available on the Web. Examples from the catalog are considered to illustrate some aspects of k versus ?? dependencies in siliciclastic reservoirs.

A case study on the application of International Classification of Functioning, Disability and Health (ICF)-based tools for vocational rehabilitation in spinal cord injury.

PubMed

Glässel, Andrea; Rauch, Alexandra; Selb, Melissa; Emmenegger, Karl; Lückenkemper, Miriam; Escorpizo, Reuben

2012-01-01

Vocational rehabilitation (VR) plays a key role in bringing persons with acquired disabilities back to work, while encouraging employment participation. The purpose of this case study is to illustrate the systematic application of International Classification of Functioning, Disability, and Health (ICF)-based documentation tools by using ICF Core Sets in VR shown with a case example of a client with traumatic spinal cord injury (SCI). The client was a 26-year-old male with paraplegia (7th thoracic level), working in the past as a mover. This case study describes the integration of the ICF Core Sets for VR into an interdisciplinary rehabilitation program by using ICF-based documentation tools. Improvements in the client's impairments, activity limitations, and participation restrictions were observed following rehabilitation. Goals in different areas of functioning were achieved. The use of the ICF Core Sets in VR allows a comprehensive assessment of the client's level of functioning and intervention planning. Specifically, the Brief ICF Core Set in VR can provide domains for intervention relevant to each member of an interdisciplinary team and hence, can facilitate the VR management process in a SCI center in Switzerland.