Understanding and using comparative healthcare information; the effect of the amount of information and consumer characteristics and skills Piloting a manualised weight management programme (Shape Up-LD) for overweight and obese persons with mild-moderate learning disabilities: study protocol for a pilot randomised controlled trial One and two year outcomes for adults with learning disabilities discharged to the community. Enhancing early child care quality and learning for toddlers at risk: the responsive early childhood program. Promoting Children's Social-Emotional Skills in Preschool Can Enhance Academic and Behavioral Functioning in Kindergarten: Findings From Head Start REDI Health and mental health social workers need information literacy skills. Using standardized patient with immediate feedback and group discussion to teach interpersonal and communication skills to advanced practice nursing students. Sleep Enhances Learning of a Functional Motor Task in Young Adults Effects on Engagement and Health Literacy Outcomes of Web-Based Materials Promoting Physical Activity in People With Diabetes: An International Randomized Trial Identifying Preliminary Domains to Detect and Measure Rheumatoid Arthritis Flares: Report of the OMERACT 10 RA Flare Workshop Literacy promotion in primary care pediatrics: can we make a difference? Role of learning potential in cognitive remediation: Construct and predictive validity Teaching phoneme awareness to pre-literate children with speech disorder: a randomized controlled trial. A rehabilitation intervention to promote physical recovery following intensive care: a detailed description of construct development, rationale and content together with proposed taxonomy to capture processes in a randomised controlled trial Using debriefing for meaningful learning to foster development of clinical reasoning in simulation. Internet-based support for self-management strategies for people with COPD–protocol for a controlled pragmatic pilot trial of effectiveness and a process evaluation in primary healthcare Using qualitative methods for attribute development for discrete choice experiments: issues and recommendations. A school-randomized clinical trial of an integrated social-emotional learning and literacy intervention: impacts after 1 school year. Does training improve understanding of core concepts in cognitive behaviour therapy by people with intellectual disabilities? A randomized experiment. eHEALS: The eHealth Literacy Scale How has the impact of 'care pathway technologies' on service integration in stroke care been measured and what is the strength of the evidence to support their effectiveness in this respect? Implementation and outcome evaluation of high-fidelity simulation scenarios to integrate cognitive and psychomotor skills for Korean nursing students. Effects of aging on implicit sequence learning: Accounting for sequence structure and explicit knowledge From rehabilitation to recovery: protocol for a randomised controlled trial evaluating a goal-based intervention to reduce depression and facilitate participation post-stroke Healthy public policy A conceptual cognitive framework. Construct Validation of a Low-fidelity Endoscopic Sinus Surgery Simulator Assessing health centre systems for guiding improvement in diabetes care A multifaceted quality improvement intervention for CVD risk management in Australian primary healthcare: a protocol for a process evaluation [CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration]. CONSORT for Reporting Randomized Controlled Trials in Journal and Conference Abstracts: Explanation and Elaboration A multifaceted strategy using mobile technology to assist rural primary healthcare doctors and frontline health workers in cardiovascular disease risk management: protocol for the SMARTHealth India cluster randomised controlled trial Pediatric Physical Therapy in Infancy: From Nightmare to Dream? A Two-Arm Randomized Trial Nurse‐Delivered Antiretroviral Treatment Adherence Intervention for People With Low Literacy Skills and Living With HIV/AIDS Effectiveness and Cost-Effectiveness of Three Types of Physiotherapy Used to Reduce Chronic Low Back Pain Disability: A Pragmatic Randomized Trial With Economic Evaluation 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 Preventing food allergy: protocol for a rapid systematic review Model transparency and validation: a report of the ISPOR-SMDM Modeling Good Research Practices Task Force--7.
Background Consumers are increasingly exposed to comparative healthcare information ( information about the quality of different healthcare providers ) . Partly because of its complexity , the use of this information has been limited . The objective of this study was to examine how the amount of presented information influences the comprehension and use of  comparative healthcare information when important consumer characteristics and skills are taken into account . Methods In this r and omized controlled experiment , comparative information on total hip or knee surgery was used as a test case . An online survey was distributed among 800 members of the NIVEL Insurants Panel and 76 hip- or knee surgery patients . Participants were assigned to one of four subgroups , who were shown 3 , 7 , 11 or 15 quality aspects of three hospitals .  We conducted Kruskall-Wallis tests , Chi-square tests and hierarchical multiple linear regression analyses to examine relationships between the amount of information and consumer characteristics and skills ( literacy , numeracy , active choice behaviour ) on one h and , and outcome measures related to effectively using information ( comprehension , perceived usefulness of information , hospital choice , ease of making a choice ) on the other h and . Results 414 people ( 47 % ) participated . Regression analysis showed that the amount of information slightly influenced the comprehension and the perceived usefulness of comparative healthcare information . It did not affect consumers ’ hospital choice and ease of making this choice . Consumer characteristics ( especially age ) and skills ( especially literacy ) were the most important factors affecting the comprehension of information and the ease of making a hospital choice . For the perceived usefulness of comparative information , active choice behaviour was the most influencing factor . Conclusion The effects of the amount of information were not unambiguous . It remains unclear what the ideal amount of quality information to be presented would be . Reducing the amount of information will probably not automatically result in more effective use of comparative healthcare information by consumers . More important , consumer characteristics and skills appeared to be more influential factors contributing to information comprehension and use . Consequently , we would suggest that more emphasis on improving consumers ’ skills is needed to enhance the use of comparative healthcare information Background National obesity rates have dramatically risen over the last decade . Being obese significantly reduces life expectancy , increases the risk of a range of diseases , and compromises quality of life . Costs to both the National Health Service and society are high . An increased prevalence of obesity in people with learning disabilities has been demonstrated . The consequences of obesity are particularly relevant to people with learning disabilities who are already confronted by health and social inequalities . In order to provide healthcare for all , and ensure e quality of treatment for people with learning disabilities , services must be developed specifically with this population in mind . The aim of this project is to pilot the evaluation of a manualised weight management programme for  overweight and obese persons with mild-moderate learning disabilities ( Shape Up-LD ) . Methods / Design An individually r and omised , controlled pilot trial in 60 overweight and obese ( body mass index ≥ 25 ) adults ( age ≥ 18 ) with mild-moderate learning disabilities and their carers will be carried out , comparing “ Shape Up-LD ” with usual care . The manualised Shape Up-LD intervention will involve 12 weekly sessions , which include healthy eating messages , advice on physical activity and use of behaviour change techniques to help people manage their weight . Assessment s of participants will be conducted at baseline , 12 weeks and 6 months . Service users and their carers and service providers will also give their perspectives on the experience of Shape Up-LD in qualitative interviews at 12 weeks . Feasibility outcomes will include recruitment rates , loss to follow-up , compliance rates , completion rates , collection of information for a cost-effectiveness analysis and an estimation of the treatment effect on weight . Discussion The findings from this study will inform our preparation for a definitive r and omised controlled trial to test the efficacy of the programme with respect to weight loss and maintenance in this population . Weight loss through Shape Up-LD could lead to improvements in health and quality of life . Costs to the National Health Service might be reduced through decreased overall service use because of improved health . The programme would also ensure a more equitable service for overweight service users with learning disabilities and fill the current gap in weight management services for this population .Trial registration International St and ard R and omised Controlled Trial No IS RCT BACKGROUND Long-stay patients with learning disabilities ( n = 214 ) were assessed in hospital and 12 and 24 months after discharge in order to examine the effects of relocation . METHOD Each resident acted as his/her own control in a prospect i ve repeated- measures design . Skills and behavioural problems were assessed by keyworkers . Self-perceived quality of life was obtained during interviews with research ers who also completed an environmental checklist of the residents ' accommodation . RESULTS There was little or no change in people 's low pre-discharge skill levels . Certain aspects of problem behaviour improved after 12 months , although socially unacceptable behaviour increased slightly . People were less depressed ( P < or = 0.01 ) 12 months after discharge ( N = 119 ) and were more satisfied ( P < or = 0.05 ) with their new ' homes ' ( n = 108 ) . There were few changes in the pattern of activities or the social networks of people 12 months later . Little or no further change in outcomes was reported 24 months after discharge . CONCLUSIONS The implementation of the deinstitutionalisation policy in Northern Irel and has been limited by the predominance of residential and nursing homes and the lack of ' ordinary ' accommodation . There is a need for purchasers and providers to give more attention to ways in which the principles of normalisation could be incorporated in the process of contracting and delivering services Despite reports of positive effects of high- quality child care , few experimental studies have examined the process of improving low- quality center-based care for toddler-age children . In this article , we report intervention effects on child care teachers ' behaviors and children 's  social , emotional , behavioral , early literacy , language , and math outcomes as well as the  teacher-child relationship . The intervention targeted the use of a set of responsive teacher practice s , derived from attachment and sociocultural theories , and a comprehensive curriculum . Sixty-five childcare classrooms serving low-income 2- and 3-year-old children were r and omized into 3 conditions : business-as-usual control , Responsive Early Childhood Curriculum ( RECC ) , and RECC plus explicit social-emotional classroom activities ( RECC+ ) . Classroom observations showed greater gains for  RECC and RECC+ teachers ' responsive practice s including helping children manage their behavior , establishing a predictable schedule , and use of cognitively stimulating activities ( e.g. , shared book reading ) compared with controls ; however , teacher behaviors did not differ for focal areas such as sensitivity and positive discipline supports . Child assessment s demonstrated that children in the interventions outperformed controls in areas of social and emotional development , although children 's performance in control and intervention groups was similar for cognitive skills ( language , literacy , and math ) . Results support the positive impact of responsive teachers and environments providing appropriate support for toddlers ' social and emotional development . Possible explanations for the absence of systematic differences in children 's cognitive skills are considered , including implication s for practice and future research targeting low-income toddlers Research Findings : This study examined processes of change associated with the positive preschool and kindergarten outcomes of children who received the Head Start REDI ( REsearch -based , Developmentally Informed ) intervention compared to usual practice Head Start .  Using data from a large-scale r and omized controlled trial ( N = 356 children , 42 % African American or Latino , all from low-income families ) , this study tests the logic model that improving preschool social-emotional skills ( e.g. , emotion underst and ing , social problem solving , and positive social behavior ) as well as language /emergent literacy skills will promote cross-domain academic and behavioral adjustment after children transition into kindergarten . Validating this logic model , the present study finds that intervention effects on 3 important kindergarten outcomes ( e.g. , reading achievement , learning engagement , and positive social behavior ) were mediated by preschool gains in the proximal social-emotional and language /emergent literacy skills targeted by the REDI intervention . It is important to note that preschool gains in social-emotional skills made unique contributions to kindergarten outcomes in reading achievement and learning engagement , even after we accounted for concurrent preschool gains in vocabulary and emergent literacy skills . Practice or Policy : These findings highlight the importance of fostering at-risk children 's social-emotional skills during preschool as a means of promoting school readiness In recent years , social work has moved in parallel with medicine and the health sciences to use evidence -based criteria to determine the actions of practitioners ( Institute of Medicine , 2001 ; Parker-Oliver & Demiris , 2006 ) . Consequently , social workers employed in health and mental health setting s are compelled to use evidence -based practice s in their work . For many practitioners , evidence -based practice means the application of empirically based service models and a trend toward interventions demonstrated to be effective in changing behavior and ameliorating clients ' problems . However , social workers , including those in medical and mental health services , are often not involved in the research that informs these practice s , and their ability to shape promoted practice s is virtually nonexistent . Health and mental health social workers increasingly view evidence -based practice as prescriptive , with research ers in centers of scholarship developing research for practitioners . This situation has exacerbated the rift between research ers and social workers who are expected to carry out empirically supported practice s , although they are not involved in the production of research or even in the synthesis of evidence that supports particular practice s and rejects others . People with research expertise and the re sources to conduct empirical inquiry are generally located in academic institutions and do not necessarily call on practitioners themselves to critically examine evidence -based practice models . When these prescribed practice s move from the rarified conditions under which r and omized controlled trials are conducted into agency setting s , they confront real-world organizational realities , Real-world " intrusions " may limit fidelity to the model produced by this " gold st and ard " of research . As a result , technology transfer , or reliability for replication of evidence -based practice s , may be compromised . Perhaps most disheartening is how this situation encourages passivity among people in the field to engage in research or remain fluent with current research . Continuing knowledge development is a shared responsibility at all levels of the social work profession ( Lewis , 2003 ) , and current education and practice structures are not encouraging practitioners to be partners in this process . We assert that people closest to direct services are best positioned to point out practice realities that distort programs . Although practice s may be supported by high-level empirical evidence , they may not prove effective or even feasible under real-world conditions . Originally , evidence -based practice was proposed for physicians to make use of the convergence of an explosion of information and technology , so that clinicians could use the growing body of research available through online data bases . Ultimately , other health professionals were supposed to formulate clinical questions , critically assess empirical studies , and decide on the best approaches to bring to a dialogue with clients . The clients were meant to be active partners in decision making about their own care . The institution of the Cochrane Collaboration ( http://www : cochrane.org./index.htm ) and the Campbell Collaboration ( http://www . campbellcollaboration.org/ ) formalized this process , and both apply rigorous , transparent st and ards to their review s of research studies . Although they are meant to serve policymakers , health workers , and people who use services , the extent to which medical social workers consult their readily available Web sites is unclear . Unlike nursing , speech therapy or rehabilitation therapy , or other health professions that have produced a burgeoning literature on information literacy skills as a central concern for educators ( Jacobs , Rosenfeld , & Haber , 2003 ; Nail-Chiwetalu & Bernstein Ratner , 2007 ) , the social work literature is for the most part silent in this area . With the exception of two recent texts that promote a bottom-up approach to evidence -based practice ( Courneyer , 2004 ; Gibbs , 2003 ) and Gary Holden 's remarkable informatics Web site for social workers ( http://www : nyu . BACKGROUND Interpersonal and communication skills ( IPCS ) are essential for advanced practice nursing ( APN ) in our increasingly complex healthcare system . The St and ardized Patient ( SP ) is a promising innovative pedagogy in medical and healthcare education ; however , its effectiveness for teaching IPCS to graduate nursing students remains unclear . OBJECTIVES We examined the effectiveness of using SP with SP feedback and group discussion to teach IPCS in graduate nursing education . DESIGN R and omized-controlled study . PARTICIPANTS First-year APN students in Taiwan . METHODS Participants were r and omly assigned to the experimental ( SP assessment s with SP feedback and group discussion ) or control ( SP assessment s only ) group . There were two outcome indicators : IPCS and student learning satisfaction ( SLS ) . The IPCS were assessed before and after the study in interviews with the SPs . SLS was measured when the study ended . RESULTS All participants expressed high SLS ( 94.44 % ) and showed significant ( p ≤ 0.025 ) improvements on IPCS total scores , interviewing , and counseling . However , there were no significant differences between groups . Qualitative feedback from encounters with SPs is described . CONCLUSIONS Using SPs to teach IPCS to APN students produced a high SLS . The students learned and significantly improved their IPCS by interviewing SPs , but future studies are needed to confirm the effectiveness of SP feedback and group discussion Background Sleep has been demonstrated to enhance simple motor skill learning “ offline ” in young adults . “ Offline learning ” refers to either the stabilization or the enhancement of a memory through the passage of time without additional practice . It remains unclear whether a functional motor task will benefit from sleep to produce offline motor skill enhancement . Physical therapists often teach clients functional motor skills ; therefore , it is important to underst and how sleep affects learning of these skills . Objective The purpose of this study was to determine whether sleep enhances the learning of a functional motor task . Design A prospect i ve , cross-sectional , repeated- measures design was used . Methods Young participants who were healthy ( N=24 ) were r and omly assigned to either a sleep group or a no-sleep group . The sleep group practice d a novel walking task in the evening and underwent retention testing the following morning , and the no-sleep group practice d the task in the morning and underwent retention testing in the evening . Outcome measures included time around the walking path and spatiotemporal gait parameters . Results Only participants who slept after practicing the novel walking task demonstrated a significant offline improvement in performance . Compared with the no-sleep group , participants in the sleep group demonstrated a significant decrease in the time around the walking path , an increase in t and em velocity , an increase in t and em step length , and a decline in t and em step time . Limitations Time-of-day effect and inability to ensure a certain amount of sleep quantity and quality of participants were limitations of the study . Conclusions This study is the first to provide evidence that sleep facilitates learning clinical ly relevant functional motor tasks . Sleep is an important factor that physical therapists should consider when teaching clients motor skills Background Developing accessible Web-based material s to support diabetes self-management in people with lower levels of health literacy is a continuing challenge . Objective The objective of this international study was to develop a Web-based intervention promoting physical activity among people with type 2 diabetes to determine whether audiovisual presentation and interactivity ( quizzes , planners , tailoring ) could help to overcome the digital divide by making digital interventions accessible and effective for people with all levels of health literacy . This study also aim ed to determine whether these material s can improve health literacy outcomes for people with lower levels of health literacy and also be effective for people with higher levels of health literacy . Methods To assess the impact of interactivity and audiovisual features on usage , engagement , and health literacy outcomes , we design ed two versions of a Web-based intervention ( one interactive and one plain-text version of the same content ) to promote physical activity in people with type 2 diabetes . We r and omly assigned participants from the United Kingdom , Austria , Germany , Irel and , and Taiwan to either an interactive or plain-text version of the intervention in English , German , or M and arin . Intervention usage was objective ly recorded by the intervention software .  Self-report measures were taken at baseline and follow-up ( immediately after participants viewed the intervention ) and included measures of health literacy , engagement ( website satisfaction and willingness to recommend the intervention to others ) , and health literacy outcomes ( diabetes knowledge , enablement , attitude , perceived behavioral control , and intention to undertake physical activity ) . Results In total , 1041 people took part in this study . Of the 1005 who completed health literacy information , 268 ( 26.67 % ) had intermediate or low levels of health literacy . The interactive intervention overall did not produce better outcomes than did the plain-text version . Participants in the plain-text intervention group looked at significantly more sections of the intervention ( mean difference –0.47 , 95 % CI –0.64 to –0.30 , P<.001 ) , but this did not lead to better outcomes . Health literacy outcomes , including attitudes and intentions to engage in physical activity , significantly improved following the intervention for participants in both intervention groups . These improvements were similar across higher and lower health literacy levels and in all countries . Participants in the interactive intervention group had acquired more diabetes knowledge ( mean difference 0.80 , 95 % CI 0.65 - 0.94 , P<.001 ) . Participants from both groups reported high levels of website satisfaction and would recommend the website to others . Conclusions Following established practice for simple , clear design and presentation and using a person-based approach to intervention development , with in-depth iterative feedback from users , may be more important than interactivity and audiovisual presentations when developing accessible digital health interventions to improve health literacy outcomes . Clinical Trial International St and ard R and omized Controlled Trial Number ( IS RCT N ) : 43587048 ; http://www.is rct n.com/IS RCT N43587048 . ( Archived by WebCite at http://www.webcitation.org/6nGhaP9bv Background . While disease flares in rheumatoid arthritis ( RA ) are a recognized aspect of the disease process , there is limited formative research to describe them . Methods . The Outcome Measures in Rheumatology Clinical Trials ( OMERACT ) RA Flare Definition Working Group is conducting an international research project to underst and the specific characteristics and impact of episodic disease worsening , or “ flare , ” so that outcome measures can be developed or modified to reflect this uncommonly measured , but very real and sometimes disabling RA disease feature . Patient research partners provided critical insights into the multidimensional nature of flare . The perspectives of patients and healthcare and research professionals are being integrated to ensure that any outcome measurement to detect flares fulfills the first OMERACT criteria of Truth . Through an iterative data -driven Delphi process , a preliminary list of key domains has been identified to evaluate flare . Results . At OMERACT 10 , consensus was achieved identifying features of flare in addition to the existing core set for RA , including fatigue , stiffness , symptom persistence , systemic features , and participation . Patient self-report of flare was identified as a component of the research agenda needed to establish criterion validity for a flare definition ; this can be used in prospect i ve studies to further evaluate the Discrimination and Feasibility components of the OMERACT filter for a flare outcome measure . Conclusion . Our work to date has provided better underst and ing of key aspects of the RA disease process as episodic , potentially disabling disease worsening even when a patient is in low disease activity . It also highlights the importance of developing ways to enhance communication between patients and clinicians and improve the ability to achieve “ tight control ” of disease BACKGROUND Reading skills are critical to children 's success in school and the increasingly technologic workforce . Children from low-income families are at risk for home environments that fail to promote emergent literacy and for reading failure . A home environment that encourages learning and parents who are involved in their children 's education are important factors in school achievement . OBJECTIVE To evaluate the effects of a literacy promoting intervention delivered by pediatric providers as part of well-child care on parent attitudes and behaviors and on child language . DESIGN / METHODS A multicultural group of 205 low-income families with 5- to 11-month-olds were prospect ively enrolled , interviewed , and r and omized to intervention ( n = 106 ) or control ( n = 99 ) groups . Families in the intervention group received developmentally appropriate children 's books and educational material s and advice about sharing books with children , while those in the control group received no books or material s relevant to literacy . After an average of 3.4 well-child visits in both groups , 153 ( 75 % ) were reinterviewed and the children 's receptive and expressive vocabulary was tested using a modified version of the MacArthur Communication and Development Inventory ( Short Form ) . Parents were asked if their child understood ( receptive vocabulary ) or said ( expressive vocabulary ) each of 100 words , half of which were in the books given . Families were found to have a Child-Centered Literacy Orientation if they mentioned reading aloud as one of their child 's favorite activities or as one of their own favorite joint activities or if they usually read together at bedtime . At follow-up toddlers were 18.4 months old on average . RESULTS Intervention and control groups had similar literacy related characteristics at baseline . There was a 40 % increase in Child-Centered Literacy Orientation among intervention families compared with 16 % among controls . Intervention families read more with their toddlers ( 4.3 vs 3.8 days/week ) . Both receptive and expressive vocabulary scores were higher in older intervention toddlers ( 18 - 25 months old ; n = 88 ) , but not in younger intervention toddlers ( 13 - 17 months old ; n = 62 ) . This significant effect of the intervention on vocabulary scores in older toddlers was found for both the 50 words in the books and those not in the books . After parent education , foreign birth and language proficiency , and child age were statistically controlled , the intervention remained significantly associated with higher language outcomes in older toddlers . However , when reading aloud was added to the multivariate analysis , the influence of the intervention was no longer evident , suggesting the intervention 's effect on child language was mediated through increased shared reading with these toddlers . CONCLUSION This simple and inexpensive intervention , delivered as part of well-child care , changed parent attitudes toward the importance of reading with their infants and toddlers . These intervention parents and their children read more together and this was associated with enhanced language development in older toddlers in this diverse group of low-income families BACKGROUND The construct , convergent , discriminant , and predictive validity of Learning Potential ( LP ) was evaluated in a trial of cognitive remediation for adults with schizophrenia-spectrum disorders . LP utilizes a dynamic assessment approach to prospect ively estimate an individual 's learning capacity if provided the opportunity for specific related learning . METHODS LP was assessed in 75 participants at study entry , of whom 41 completed an eight-week cognitive remediation ( CR ) intervention , and 22 received treatment-as-usual ( TAU ) . LP was assessed in a " test-train-test " verbal learning paradigm . Incremental predictive validity was assessed as the degree to which LP predicted memory skill acquisition above and beyond prediction by static verbal learning ability . RESULTS Examination of construct validity confirmed that LP scores reflected use of trained semantic clustering strategy . LP scores correlated with executive functioning and education history , but not other demographics or symptom severity . Following the eight-week active phase , TAU evidence d little substantial change in skill acquisition outcomes , which related to static baseline verbal learning ability but not LP . For the CR group , LP significantly predicted skill acquisition in domains of verbal and visuospatial memory , but not auditory working memory . Furthermore , LP predicted skill acquisition incrementally beyond relevant background characteristics , symptoms , and neurocognitive abilities . CONCLUSIONS Results suggest that LP assessment can significantly improve prediction of specific skill acquisition with cognitive training , particularly for the domain assessed , and thereby may prove useful in individualization of treatment BACKGROUND Awareness of individual phonemes in words is a late-acquired level of phonological awareness that usually develops in the early school years . It is generally agreed to have a close relationship with early literacy development , but its role in speech change is less well understood . Speech and language therapy for children with speech disorder involves tasks that appear , either implicitly or explicitly , to require a phonemic level of awareness . However , children typically attend for intervention at a pre-school , pre-literate stage , i.e. before they would be expected to have developed the relevant phoneme segmentation and manipulation skills . AIMS To investigate whether it is possible to teach phoneme awareness skills to pre-literate children with speech disorder . METHODS & PROCEDURES In a r and omized controlled trial design 42 children with speech disorder , aged 4;0 - 4;6 , were allocated to either a phonological awareness or a language stimulation programme . Children were assessed on four measures of phoneme awareness ( alliteration awareness , phoneme isolation , word segmentation and phoneme addition/deletion ) immediately before and after the programme and categorized as ' improved ' or ' not improved ' according to predetermined criteria . Fisher 's Exact test was used to compare outcome in the two groups . OUTCOMES & RESULTS Significantly more children improved in the phonological awareness group than in the language stimulation group for three out of the four measures ( all except alliteration awareness ) . However , for the two most advanced tasks ( segmentation and addition/deletion ) only a small minority of children showed improvement . A marked improvement in Phoneme Isolation was made by the majority of children in the phonological awareness group . CONCLUSIONS It is possible to teach some advanced phoneme awareness skills to some pre-literate children . Phoneme Isolation was the most easily learned and is a skill that appears very relevant to speech and language therapy . However , phoneme addition , deletion and word segmentation showed relatively limited improvement and only in a small number of cognitively able and older children . Whereas isolation of word initial consonants appears to be a skill that can be triggered at 4;0 - 4;6 by relevant activities , most children in the study were not cognitively ready for more advanced , abstract phoneme manipulation tasks . This raises questions about how speech and language therapists should tackle many common errors and the age at which we should aim to develop or draw on phoneme awareness to stimulate speech change Background Increasing numbers of patients are surviving critical illness , but survival may be associated with a constellation of physical and psychological sequelae that can cause ongoing disability and reduced health-related quality of life . Limited evidence currently exists to guide the optimum structure , timing , and content of rehabilitation programmes . There is a need to both develop and evaluate interventions to support and expedite recovery during the post-ICU discharge period . This paper describes the construct development for a complex rehabilitation intervention intended to promote physical recovery following critical illness . The intervention is currently being evaluated in a r and omised trial ( IS RCT N09412438 ; funder Chief Scientists Office , Scotl and ) . Methods The intervention was developed using the Medical Research Council ( MRC ) framework for developing complex healthcare interventions . We ensured representation from a wide variety of stakeholders including content experts from multiple specialties , method ologists , and patient representation . The intervention construct was initially based on literature review , local observational and audit work , qualitative studies with ICU survivors , and brainstorming activities . Iterative refinement was aided by the publication of a National Institute for Health and Care Excellence guideline ( No. 83 ) , publicly available patient stories ( Healthtalkonline ) , a stakeholder event in collaboration with the James Lind Alliance , and local piloting . Modelling and further work involved a feasibility trial and development of a novel generic rehabilitation assistant ( GRA ) role . Several rounds of external peer review during successive funding applications also contributed to development . Results The final construct for the complex intervention involved a dedicated GRA trained to pre-defined competencies across multiple rehabilitation domains ( physiotherapy , dietetics , occupational therapy , and speech/ language therapy ) , with specific training in post-critical illness issues . The intervention was from ICU discharge to 3 months post-discharge , including inpatient and post-hospital discharge elements . Clear strategies to provide information to patients /families were included . A detailed taxonomy was developed to define and describe the processes undertaken , and capture them during the trial . The detailed process measure description , together with a range of patient , health service , and economic outcomes were successfully mapped on to the modified CONSORT recommendations for reporting non-pharmacologic trial interventions . Conclusions The MRC complex intervention framework was an effective guide to developing a novel post-ICU rehabilitation intervention . Combining a clearly defined new healthcare role with a detailed taxonomy of process and activity enabled the intervention to be clearly described for the purpose of trial delivery and reporting . These data will be useful when interpreting the results of the r and omised trial , will increase internal and external trial validity , and help others implement the intervention if the intervention proves clinical ly and cost effective Debriefing is critical to learning from simulation experiences , yet the literature reports little research describing best practice s within nursing . Debriefing for Meaningful Learning ( DML ) is a systematic process for debriefing in which teachers and students explicate different aspects of reflection and generate new meanings from simulation experiences . The purpose of this exploratory , quasi-experimental , pretest-posttest study was to test the relationship of DML on the development of clinical reasoning skills in prelicensure nursing students when compared with customary debriefing strategies and on students ' perception of quality of the debriefing experience . Analysis of data demonstrated a greater change in clinical reasoning skills and identification of higher- quality debriefing and a positive correlation between clinical reasoning and perception of quality . Findings demonstrate that DML is an effective debriefing method . It contributes to the body of knowledge supporting the use of debriefing in simulation learning and supports the development of best teaching practice Introduction The use of adequate self-management strategies for people with chronic obstructive pulmonary disease ( COPD ) reduces healthcare use , improves health-related quality of life ( HRQoL ) and recovery after acute exacerbations . However , not many people with COPD receive support that promotes the use of such strategies and therefore new methods to facilitate and promote the use of self-management strategies are highly warranted . This pilot trial aims to evaluate the feasibility of the study design and study procedures considering effectiveness of the novel intervention , the COPD -web . Methods and analysis The overall design is a pragmatic controlled pilot trial with pre assessment s and post assessment s and a parallel process evaluation . Patients with the diagnosis of COPD will be eligible for the study . The intervention group will be recruited when visiting one of the six participating primary care units in Sweden . The control group will be identified from the unit 's computerised registers . The intervention , the COPD -web , is an interactive web page with two sections ; one directed at people with COPD and one at healthcare professionals . The sections aim to support patients ’ self-management skills— and to facilitate the provision of support for self-management strategies , respectively . Effectiveness with regard to patients ’ symptoms , HRQoL , knowledge of and readiness for COPD -related self-management , health literacy , self-efficacy for physical activity and time spent in physical activity and time being sedentary , and further , healthcare professionals ’ knowledge of and readiness to support COPD -related self-management strategies will be assessed using question naires at 3 and 12 months . The process evaluation will include observations and interviews . Ethics and dissemination Ethical approval has been obtained . Findings will be presented at conferences , su bmi tted for publication in peer- review ed publications and presented to the involved healthcare professionals , patients and to patient organisations . Trial registration number Clinical Trials.gov : Attribute generation for  discrete choice experiments ( DCEs ) is often poorly reported , and it is unclear whether this element of research is conducted rigorously . This paper explores issues associated with developing attributes for DCEs  and contrasts different qualitative approaches . The paper draws on eight studies , four developed attributes for measures , and four developed attributes  for more ad hoc policy questions . Issues that have become apparent through these studies include the following : the theoretical framework for r and om utility theory and the need for attributes that are neither too close to the latent construct nor too intrinsic to people 's personality ; the need to think about attribute development as a two-stage process involving conceptual development followed by refinement of language to convey the intended meaning ; and the difficulty in resolving tensions inherent in the reductiveness of condensing complex and nuanced qualitative findings into precise terms . The comparison of alternative qualitative approaches suggests that the nature of data collection will depend both on the characteristics of the question ( its sensitivity , for example ) and the availability of existing qualitative information . An iterative , constant comparative approach to analysis is recommended . Finally , the paper provides a series of recommendations for improving the reporting of this element of DCE studies OBJECTIVE To report experimental impacts of a universal , integrated school-based intervention in social-emotional learning and literacy development on change over 1 school year in 3rd- grade children 's social-emotional , behavioral , and academic outcomes . METHOD This study employed a school-r and omized , experimental design and included 942 3rd- grade children ( 49 % boys ; 45.6 % Hispanic/Latino , 41.1 % Black/African American , 4.7 % non-Hispanic White , and 8.6 % other racial/ethnic groups , including Asian , Pacific Isl and er , Native American ) in 18 New York City public elementary schools . Data on children 's social-cognitive processes ( e.g. , hostile attribution biases ) , behavioral symptomatology ( e.g. , conduct problems ) , and literacy skills and academic achievement ( e.g. , reading achievement ) were collected in the fall and spring of 1 school year . RESULTS There were main effects of the 4Rs Program after 1 year on only 2 of the 13 outcomes examined . These include children 's self-reports of hostile attributional biases ( Cohen 's d = 0.20 ) and depression ( d = 0.24 ) . As expected based on program and developmental theory , there were impacts of the intervention for those children identified by teachers at baseline with the highest levels of aggression ( d = 0.32 - 0.59 ) on 4 other outcomes : children 's self-reports of aggressive fantasies , teacher reports of academic skills , reading achievement scaled scores , and children 's attendance . CONCLUSIONS This report of effects of the 4Rs intervention on individual children across domains of functioning after 1 school year represents an important first step in establishing a better underst and ing of what is achievable by a schoolwide intervention such as the 4Rs in its earliest stages of unfolding . The first-year impacts , combined with our knowledge of sustained and exp and ed effects after a second year , provide evidence that this intervention may be initiating positive developmental cascades both in the general population of students and among those at highest behavioral risk . ( PsycINFO Data base Record ( c ) 2010 APA , all rights reserved ) BACKGROUND People with intellectual disabilities ( ID ) experience similar or even higher rates of mental health problems than the general population and there is a need to develop appropriate treatments . Cognitive behaviour therapy ( CBT ) is effective for a wide range of disorders in the general population . However , there is some evidence that people with ID may lack the cognitive skills needed to take part in CBT . AIMS To test if people with ID can learn skills required for CBT , specifically the ability to distinguish between thoughts , feelings , and behaviours and to link thoughts and feelings ( cognitive mediation ) . METHOD A r and omized independent groups design was used to examine the effect of training in CBT on two tasks measuring  CBT skills .  Thirty-four adults with ID were r and omly allocated to the experimental condition ( N=18 ) or to the control condition ( N=16 ) .  CBT skills were assessed blind at baseline and after the intervention . RESULTS The training led to significant improvements in participants ' ability to link thoughts and feelings , and this skill was generalized to new material . There was no effect of training on participants ' ability to distinguish amongst thoughts , feelings , and behaviours .  People with ID can , therefore , learn some skills required for CBT . This implies that preparatory training for CBT might be useful for people with ID . The results might be applicable to other groups who find aspects of CBT difficult Background Electronic health re sources are helpful only when people are able to use them , yet there remain few tools available to assess consumers ’ capacity for engaging in eHealth . Over 40 % of US and Canadian adults have low basic literacy levels , suggesting that eHealth re sources are likely to be inaccessible to large segments of the population . Using information technology for health requires eHealth literacy — the ability to read , use computers , search for information , underst and health information , and put it into context . The eHealth Literacy Scale ( eHEALS ) was design ed ( 1 ) to assess consumers ’ perceived skills at using information technology for health and ( 2 ) to aid in determining the fit between eHealth programs and consumers . Objectives The eHEALS is an 8-item measure of eHealth literacy developed to measure consumers ’ combined knowledge , comfort , and perceived skills at finding , evaluating , and applying electronic health information to health problems . The objective of the study was to psychometrically evaluate the properties of the eHEALS within a population context . A youth population was chosen as the focus for the initial development primarily because they have high levels of eHealth use and familiarity with information technology tools . Methods Data were collected at baseline , post-intervention , and 3- and 6-month follow-up using control group data as part of a single session , r and omized intervention trial evaluating Web-based eHealth programs . Scale reliability was tested using item analysis for internal consistency ( coefficient alpha ) and test-retest reliability estimates . Principal components factor analysis was used to determine the theoretical fit of the measures with the data . Results A total of 664 participants ( 370 boys ; 294 girls ) aged 13 to 21 ( mean = 14.95 ; SD = 1.24 ) completed the eHEALS at four time points over 6 months . Item analysis was performed on the 8-item scale at baseline , producing a tight fitting scale with α = .88 . Item-scale correlations ranged from r = .51 to .76 . Test-retest reliability showed modest stability over time from baseline to 6-month follow-up ( r = .68 to .40 ) . Principal components analysis produced a single factor solution ( 56 % of variance ) . Factor loadings ranged from .60 to .84 among the 8 items . Conclusions The eHEALS reliably and consistently captures the eHealth literacy concept in repeated administrations , showing promise as tool for assessing consumer comfort and skill in using information technology for health . Within a clinical environment , the eHEALS has the potential to serve as a means of identifying those who may or may not benefit from referrals to an eHealth intervention or re source . Further research needs to examine the applicability of the eHEALS to other population s and setting s while exploring the relationship between eHealth literacy and health care outcomes Background Across the developed world , we are witnessing an increasing emphasis on the need for more closely coordinated forms of health and social care provision . Integrated care pathways ( ICPs ) have emerged as a response to this aspiration and are believed by many to address the factors which contribute to service integration . ICPs map out a patient 's journey , providing coordination of services for users . They aim to have : ' the right people , doing the right things , in the right order , at the right time , in the right place , with the right outcome ' . The value for ICPs in supporting the delivery of care across organisational boundaries , providing greater consistency in practice , improving service continuity and increasing collaboration has been advocated by many . However , there is little evidence to support their use , and the need for systematic evaluations in order to measure their effectiveness has been widely identified . A recent Cochrane review assessed the effects of ICPs on functional outcome , process of care , quality of life and hospitalisation costs of in patients with acute stroke , but did not specifically focus on service integration or its derivatives . To the best of our knowledge , no such systematic review of the literature exists . Objectives To systematic ally review all high‐ quality studies which have evaluated the impact of care pathway technologies on ' service integration ' and its derivatives in stroke care To examine how elements of service integration are defined in such studies To examine the type of evidence utilised to measure service integration To analyse the weight of evidence used to support cl aims about the effectiveness of ICPs on improving service integration To produce recommendations for ICP developers , users and evaluators . Inclusion criteria Types of participants The review focused on the care of adult patients who had suffered a stroke . It included the full spectrum of services ‐ acute care , rehabilitation and long‐term support ‐ in hospital and community setting s. Types of intervention(s)/phenomena of interest Integrated care pathways were the intervention of interest , defined for the purpose of this review as ' a multidisciplinary tool to improve the quality and efficiency of evidence based care and is used as a communication tool between professionals to manage and st and ardise the outcome orientated care ' . Here ' multidisciplinary ' is taken to refer to the involvement of two or more disciplines . Types of outcomes Service integration ' was the outcome of interest however , this was defined and measured in the selected studies . Types of studies This review was concerned with how ' service integration ' was defined in evaluations of ICPs ; the type of evidence utilised in measuring the impact of the intervention and the weight of evidence to support the effectiveness of care pathway technologies on ' service integration ' . Studies that made an explicit link between ICPs and service integration were included in the review . Evidence generated from r and omised controlled trials , quasi‐experimental , qualitative and health economics research was sought . The search was limited to publications after 1980 , coinciding with the emergence of ICPs in the healthcare context . Assessment for inclusion of foreign papers was based on the English‐ language abstract , where available . These were included only if an English translation was available . Exclusion criteria This review excluded studies that : focused only on a single aspect of stroke care ( e.g. dysphasia ) evaluated ICPs as part of a wider program of service development did not make an explicit link between ICPs and service integration did not meet the definition of ICP utilised for the purpose s of the review focused exclusively on the outcomes of variance analysis Search strategy In order to avoid replication , the Joanna Briggs Institute for Evidence Based Nursing and Midwifery Data base and the Cochrane Library were search ed to establish that no systematic review s existed and none were in progress . A three‐stage search strategy was then used to identify both published and unpublished studies ( see Appendix III ) . Data collection Our search strategy located 2123 papers , of which 39 were retrieved for further evaluation . We critically appraised seven papers , representing five studies . These were all evaluation studies and , as is typical in this field , comprised a range of study design s and data collection methods . Owing to the diversity of the study types included in the review , we developed a single‐ appraisal checklist and data ‐ extraction tool which could be applied to all research design s.32 The tool drew on the Joanna Briggs Institute ( JBI ) appraisal checklists for experimental studies and interpretive and critical research , and also incorporated specific information and issues which were relevant for our purpose s ( see Appendix VI ) . This extends the thinking outlined in Lyne et al.31 in which , drawing on Campbell and Stanley 's classic paper , the case is made for developing an appraisal tool which is applicable to all types of evaluation , irrespective of study design . In assessing the quality of the papers , we were sympathetic to the method ological challenges of evaluating complex interventions such as ICPs . We were also cognisant of the very real constraints in which service evaluations are frequently undertaken in healthcare context s. In accordance with the aims of this particular review , we have included studies , which are method ologically weaker than is typical of many systematic review s because , in our view , in the absence of stronger evidence , they yield useful information . Data synthesis Given the heterogeneity of the included studies , meta‐ analysis and /or qualitative synthesis was not possible . A narrative summary of the study findings is presented . Results ICPs can be effective in ensuring that patients receive relevant clinical interventions and /or assessment s in a timely manner , although these improvements may reflect better documentation rather than actual changes in practice . ICPs can be effective in improving the documentation of rehabilitation goals , documentation of communication with patients , carers ( diagnosis , prognosis and follow‐up arrangements ) and documentation of notification of primary care physicians of discharge . However , this can create additional burdens of work for staff . Early studies of  ICP‐managed care in the acute stroke context have demonstrated reduced length of stay without any associated adverse effects on discharge destination , morbidity or mortality . These effects do not reach statistical significance , however , and may reflect wider changes in service provision and a general trend towards reduced length of hospital stay . While later studies in the acute and rehabilitation context s do not reveal any significant reduction in length of stay , they do report greater documented use of certain clinical interventions and assessment s , suggesting that ICPs can be effective in mobilising hospital re sources around the patient . ICPs implemented in the context of acute stroke care can be effective in reducing the occurrence of urinary tract infections , although we do not know whether this can be attributed to improved service integration . ICP management in stroke rehabilitation may not be flexible enough to meet diverse patient needs and can result in insufficient attention to higher‐level functioning and carer needs influencing perceptions of quality of life . ICP management may assist in clarifying role boundaries and a shared underst and ing of the work , but this can result in some members of the disciplinary team perceiving that their contribution is not appropriately reflected in the documentation . There is some evidence that ICPs may be effective in changing professional behaviours in the desired direction where there is scope for improvement , but in situations in which multidisciplinary working is effective , their positive effects may be limited . Furthermore , it is far from clear what the active ingredients of ICPs actually are . Kwan et al. suggest that it was the process of ICP development that had most impact on behaviours rather than the use of the artefact per se.20 None of the studies assessed the balance of costs and benefits of ICP use . Therefore , we do not know whether the costs of ICP development and implementation are justified by any of the reported benefits . Conclusions Implication s for practice There is some evidence that ICPs may support certain elements of service integration in the context of stroke care . This seems to be as a result of their ability to support the timely implementation of clinical interventions and the mobilisation of re sources around the patient without incurring additional increases in length of stay . ICPs appear to be most successful in improving service coordination in the acute stroke context where patient care trajectories are predictable . Their value in the context of rehabilitation setting s in which recovery pathways are more variable is less clear . There is some evidence that ICPs may be effective in bringing about behavioural changes in context s where deficiencies in service provision have been identified . Their value in context s where inter‐professional working is well established is less clear . While earlier before and after studies show a reduction in length of stay in ICP‐managed care , this may reflect wider healthcare trends , and the failure of later studies to demonstrate further reductions suggests that there may be limits as to how far this can continue to be reduced . There is some evidence to suggest that ICPs bring about improvements in documentation , but we do not know how far documented practice reflects actual practice . It is unclear how ICPs have their effects and the relative importance of the process of development and the artefact in use . As none of the studies review ed included an economic evaluation , moreover , it remains unclear whether the benefits of ICPs OBJECTIVES This study is involved in design ing high-fidelity simulations reflecting the Korean nursing education environment . In addition , it evaluated the simulations by nursing students ' learning outcomes and perceptions of the simulation design features . DESIGN A quantitative design was used in two separate phases . SETTING S AND PARTICIPANTS For the first phase , five nursing experts participated in verifying the appropriateness of two simulation scenarios that reflected the intended learning objectives . For the second phase , 69 nursing students in the third year of a bachelor 's degree at a nursing school participated in evaluating the simulations and were r and omized according to their previous course grade s. METHODS The first phase verified the two simulation scenarios using a question naire . The second phase evaluated students ' perceptions of the  simulation design , self-confidence , and critical thinking skills using a quasi-experimental post-test design . ANCOVA was used to compare the experimental and control groups , and correlation coefficient analysis was used to determine the correlation among them . RESULTS We created 2 simulation scenarios to integrate cognitive and psychomotor skills according to the learning objectives and clinical environment in Korea . The experimental group had significantly higher scores on self-confidence in the first scenario . The positive correlations between perceptions of the simulation design features , self-confidence , and critical thinking skill scores were statistically significant . CONCLUSIONS Students with a more positive perception of the design features of the simulations had better learning outcomes . Based on this result , simulations need to be design ed and implemented with more differentiation in order to be perceived more appropriately by students The present research was intended to examine the sequence learning ability of elderly people — with a focus on comparing sequences with different structural characteristics and on properly assessing explicit knowledge . Experiment 1 showed that learning-related improvements in serial reaction time task performance were greater for young than elderly subjects , and elderly subjects were especially poor at learning a sequence with complex structural characteristics . Measures of recognition memory showed that neither young nor elderly subjects showed above-chance explicit knowledge of the sequences . Experiment 2 was design ed to test the validity and sensitivity of the explicit recognition measures by comparing young subjects in groups given all r and om trials , given sequence trials with implicit instructions , or given sequence trials with explicit instructions . Experiment 2 confirmed the sensitivity of the recognition measures to explicit knowledge , so it is concluded that group effects in Exp . 1 reflect age-related differences in implicit learning Background There is much discourse in healthcare about the importance of client-centred rehabilitation , however in the realm of community-based therapy post-stroke there has been little investigation into the efficacy of goal -directed practice that reflects patients ' valued activities . In addition , the effect of active involvement of carers in such a rehabilitation process and their subsequent contribution to functional and emotional recovery post-stroke is unclear . In community based rehabilitation , interventions based on patients ' perceived needs may be more likely to alter such outcomes . In this paper , we describe the methodology of a r and omised controlled trial of an integrated approach to facilitating patient goal achievement in the first year post-stroke . The effectiveness of this intervention in reducing the severity of post-stroke depression , improving participation status and health-related quality of life is examined . The impact on carers is also examined . Methods / Design Patients ( and their primary carers , if available ) are r and omly allocated to an intervention or control arm of the study . The intervention is multimodal and aims to screen for adverse stroke sequelae and address ways to enhance participation in patient-valued activities . Intervention methods include : telephone contacts , written information provision , home visitation , and contact with treating health professionals , with further relevant health service referrals as required . The control involves treatment as usual , as determined by inpatient and community rehabilitation treating teams . Formal blinded assessment s are conducted at discharge from inpatient rehabilitation , and at six and twelve months post-stroke . The primary outcome is depression . Secondary outcome measures include participation and activity status , health-related quality of life , and self-efficacy . Discussion The results of this trial will assist with the development of a model for community-based rehabilitation management for stroke patients and their carers , with emphasis on goal -directed practice to enhance home and community participation status . Facilitation of participation in valued activities may be effective in reducing the incidence or severity of post-stroke depression , as well as enhancing the individual 's perception of their health-related quality of life . The engagement of carers in the rehabilitation process will enable review of the influence of the broader social context on recovery . Trial registration Australia and New Zeal and Clinical Trials Register ( ANZCTR ) : More than three decades ago , the report A New Perspective on the Health of Canadians ( 1974 ) highlighted the significance of other determinants than the healthcare system . The adoption of healthy public policy was identified in the Ottawa Charter ( 1986 ) as one of five strategies aim ing to promote health . It must now be acknowledged that even if we have a better underst and ing of health determinants , the latter are not necessarily taken into consideration when developing public policies . The purpose of this paper is to help foster a better underst and ing of the healthy public policies by presenting a conceptual framework that is inspired by the Advocacy Coalition Framework developed by Sabatier and Jenkins-Smith ( 1999 ) . On the one h and , this paper intends to show the relevance of the notion of subsystem of public policies in healthy public policy process . On the other , it aims to convince that it is necessary to channel the analysis around the decision-making process , the prospect i ve evaluation of public policies and the knowledge transfer and appropriation process . Finally , the purpose of this paper is to contribute to the ongoing debate about the role of knowledge , values or beliefs in the formulation and adoption of public policies . After briefly summarizing the theoretical developments in studies on public policies , the logic and components of the ACF are introduced . The main criticisms regarding the ACF are then examined , followed by an introduction of the conceptual framework that is adapted to the reality of healthy public policies . The notions of the subsystem of public policy(ies ) , of process and of learning process are central to this framework Background Before a simulator becomes widely accepted , it must be relevant , affordable , and accessible . We have developed a low-cost model emphasizing the basic skills required for endoscopic sinus surgery ( ESS ) . It is noninvasive , free from risk of infection , and an excellent low-pressure learning opportunity . The current study was design ed to assess the construct validity of our simulator . Methods We conducted a stratified r and omized crossover-control study . Otolaryngology residents , fellows , and faculty performed predetermined tasks on the model or cadaver , and then switched . Evaluation included h and motion analysis , task time , and blinded expert review . Results Sixteen subjects at various levels of training participated . Cadaver performance correlated well with level of training and previous experience with ESS . However , model performance did not demonstrate statistically significant correlation . Conclusion Our model was unable to demonstrate clear construct validity at this time . Material s and structural modifications are in progress . Pending further validation , its low-cost construction possesses potential for integration into otolaryngology residency curricula . Assessment of the simulator 's ability to improve surgical skill is also planned Background Aboriginal people in Australia experience the highest prevalence of diabetes in the country , an excess of preventable complications and early death . There is increasing evidence demonstrating the importance of healthcare systems for improvement of chronic illness care . The aims of this study were to assess the status of systems for chronic illness care in Aboriginal community health centres , and to explore whether more developed systems were associated with better quality of diabetes care . Methods This cross-sectional study was conducted in 12 Aboriginal community health centres in the Northern Territory of Australia .  Assessment of Chronic Illness Care scale was adapted to measure system development in health centres , and administered by interview with health centre staff and managers . Based on a r and om sample of 295 clinical records from attending clients with diagnosed type 2 diabetes , processes of diabetes care were measured by rating of health service delivery against best- practice guidelines . Intermediate outcomes included the control of HbA1c , blood pressure , and total cholesterol . Results Health centre systems were in the low to mid-range of development and had distinct areas of strength and weakness . Four of the six system components were independently associated with quality of diabetes care : an increase of 1 unit of score for organisational influence , community linkages , and clinical information systems , respectively , was associated with 4.3 % , 3.8 % , and 4.5 % improvement in adherence to process st and ards ; likewise , organisational influence , delivery system design and clinical information systems were related to control of HbA1c , blood pressure , and total cholesterol . Conclusion The state of development of health centre systems is reflected in quality of care outcome measures for patients . The health centre systems assessment tool should be useful in assessing and guiding development of systems for improvement of diabetes care in similar setting s in Australia and internationally Background Cardiovascular disease ( CVD ) is the leading cause of death and disability worldwide . Despite the widespread availability of evidence -based clinical guidelines and vali date d risk predication equations for prevention and management of CVD , their translation into routine practice is limited . We developed a multifaceted quality improvement intervention for CVD risk management which incorporates electronic decision support , patient risk communication tools , computerised audit and feedback tools , and monthly , peer-ranked performance feedback via a web portal . The intervention was implemented in a cluster r and omised controlled trial in 60 primary healthcare services in Australia . Overall , there were improvements in risk factor recording and in prescribing of recommended treatments among under-treated individuals , but it is unclear how this intervention was used in practice and what factors promoted or hindered its use . This information is necessary to optimise intervention impact and maximally implement it in a post-trial context . In this study protocol , we outline our methods to conduct a theory-based , process evaluation of the intervention . Our aims are to underst and how , why , and for whom the intervention produced the observed outcomes and to develop effective strategies for translation and dissemination . Methods / Design We will conduct four discrete but inter-related studies taking a mixed methods approach . Our quantitative studies will examine ( 1 ) the longer term effectiveness of the intervention post-trial , ( 2 ) patient and health service level correlates with trial outcomes , and ( 3 ) the health economic impact of implementing the intervention at scale . The qualitative studies will ( 1 ) identify healthcare provider perspectives on implementation barriers and enablers and ( 2 ) use video ethnography and patient semi-structured interviews to underst and how cardiovascular risk is communicated in the doctor/patient interaction both with and without the use of intervention . We will also assess the costs of implementing the intervention in Australian primary healthcare setting s which will inform scale-up considerations . Discussion This mixed methods evaluation will provide a detailed underst and ing of the process of implementing a  quality improvement intervention and identify the factors that might influence scalability and sustainability . Trials registration 12611000478910 BACKGROUND Clear , transparent , and sufficiently detailed abstract s of conferences and journal articles related to r and omized controlled trials ( RCTs ) are important , because readers often base their assessment of a trial solely on information in the abstract . Here , we extend the CONSORT ( Consoli date d St and ards of Reporting Trials ) Statement to develop a minimum list of essential items , which authors should consider when reporting the results of a RCT in any journal or conference abstract . METHODS AND FINDINGS We generated a list of items from existing quality assessment tools and empirical evidence . A three-round , modified-Delphi process was used to select items . In all , 109 participants were invited to participate in an electronic survey ; the response rate was 61 % . Survey results were presented at a meeting of the CONSORT Group in Montebello , Canada , January 2007 , involving 26 participants , including clinical trialists , statisticians , epidemiologists , and biomedical editors . Checklist items were discussed for eligibility into the final checklist . The checklist was then revised to ensure that it reflected discussion s held during and subsequent to the meeting . CONSORT for Abstract s recommends that abstract s relating to RCTs have a structured format . Items should include details of trial objectives ; trial design ( e.g. , method of allocation , blinding/masking ) ; trial participants ( i.e. , description , numbers r and omized , and number analyzed ) ; interventions intended for each r and omized group and their impact on primary efficacy outcomes and harms ; trial conclusions ; trial registration name and number ; and source of funding . We recommend the checklist be used in conjunction with this explanatory document , which includes examples of good reporting , rationale , and evidence , when available , for the inclusion of each item . CONCLUSIONS CONSORT for Abstract s aims to improve reporting of abstract s of RCTs published in journal articles and conference proceedings . It will help authors of abstract s of these trials provide the detail and clarity needed by readers wishing to assess a trial 's validity and the applicability of its results Background Clear , transparent , and sufficiently detailed abstract s of conferences and journal articles related to r and omized controlled trials ( RCTs ) are important , because readers often base their assessment of a trial solely on information in the abstract . Here , we extend the CONSORT ( Consoli date d St and ards of Reporting Trials ) Statement to develop a minimum list of essential items , which authors should consider when reporting the results of a RCT in any journal or conference abstract . Methods and Findings We generated a list of items from existing quality assessment tools and empirical evidence . A three-round , modified-Delphi process was used to select items . In all , 109 participants were invited to participate in an electronic survey ; the response rate was 61 % . Survey results were presented at a meeting of the CONSORT Group in Montebello , Canada , January 2007 , involving 26 participants , including clinical trialists , statisticians , epidemiologists , and biomedical editors . Checklist items were discussed for eligibility into the final checklist . The checklist was then revised to ensure that it reflected discussion s held during and subsequent to the meeting . CONSORT for Abstract s recommends that abstract s relating to RCTs have a structured format . Items should include details of trial objectives ; trial design ( e.g. , method of allocation , blinding/masking ) ; trial participants ( i.e. , description , numbers r and omized , and number analyzed ) ; interventions intended for each r and omized group and their impact on primary efficacy outcomes and harms ; trial conclusions ; trial registration name and number ; and source of funding . We recommend the checklist be used in conjunction with this explanatory document , which includes examples of good reporting , rationale , and evidence , when available , for the inclusion of each item . Conclusions CONSORT for Abstract s aims to improve reporting of abstract s of RCTs published in journal articles and conference proceedings . It will help authors of abstract s of these trials provide the detail and clarity needed by readers wishing to assess a trial 's validity and the applicability of its results Background Blood Pressure related disease affected 118 million people in India in the year 2000 ; this figure will double by 2025 . Around one in four adults in rural India have hypertension , and of those , only a minority are accessing appropriate care . Health systems in India face substantial challenges to meet these gaps in care , and innovative solutions are needed . Methods We hypothesise that a multifaceted intervention involving capacity strengthening of primary healthcare doctors and non-physician healthcare workers through use of a mobile device-based clinical decision support system will result in improved blood pressure control for individuals at high risk of a cardiovascular disease event when compared with usual healthcare . This intervention will be implemented as a stepped wedge , cluster r and omised controlled trial in 18 primary health centres and 54 villages in rural And hra Pradesh involving adults aged ≥40 years at high cardiovascular disease event risk ( approximately 15,000 people ) . Cardiovascular disease event risk will be calculated based on World Health Organisation/International Society of Hypertension ’s region-specific risk charts . Cluster r and omisation will occur at the level of the primary health centres . Outcome analyses will be conducted blinded to intervention allocation . Expected outcomes The primary study outcome is the difference in the proportion of people meeting guideline -recommended blood pressure targets in the intervention period vs. the control period . Secondary outcomes include mean reduction in blood pressure levels ; change in other cardiovascular disease risk factors , including body mass index , current smoking , reported healthy eating habits , and reported physical activity levels ; self-reported use of blood pressure and other cardiovascular medicines ; quality of life ( using the EQ-5D ) ; and cardiovascular disease events ( using hospitalisation data ) . Trial outcomes will be accompanied by detailed process and economic evaluations . Significance The findings are likely to inform policy on a scalable strategy to overcome entrenched inequities in access to effective healthcare for under-served population s in low and middle income country setting s . Trial registration Clinical Trial Registry India CTRI/2013/06/003753 Background Systematic review s have suggested that early intervention by means of specific motor training programs and general developmental programs in which parents learn how to promote infant development may be the most promising ways to promote infant motor and cognitive development of infants with or at high risk for developmental motor disorders . Objective The purpose of this study was to investigate the effects of a recently developed pediatric physical therapy intervention program ( “ Coping With and Caring for Infants With Special Needs ” [ COPCA ] ) on the development of infants at high risk for developmental disorders using a combined approach of a 2-arm r and omized trial and process evaluation . Setting The study was conducted at the University Medical Center Groningen in the Netherl and s. Participants and Intervention Forty-six infants at high risk for developmental disorders were r and omly assigned to receive  COPCA ( a family-centered program ) ( n=21 ) or traditional infant physical therapy ( TIP ) ( n=25 ) between 3 to 6 months corrected age ( CA ) . Developmental outcome was assessed by blinded assessors at 3 , 6 , and 18 months CA with a neurological examination , the Alberta Infant Motor Scales , the Pediatric Evaluation of Disability Inventory , and the Mental Developmental Index ( MDI ) of the Bayley Scales of Infant Development . Contents of the intervention were analyzed by a quantitative video analysis of therapy sessions . Quantified physical therapy actions were correlated to evaluate associations between intervention and developmental outcome components . Results The trial revealed that developmental outcome in both groups was largely identical . Process evaluation showed that typical COPCA actions—(1 ) family involvement and educational actions , ( 2 ) application of a wide variation in challenging the infant to produce motor behavior by himself or herself and allowing the infant to continue this activity , and ( 3 ) stimulation of motor behavior at the limit of the infant 's capabilities — had positive correlations with developmental outcome at 18 months CA . The use of h and ling techniques was negatively associated with the Pediatric Evaluation of Disability Inventory outcome at 18 months CA . Limitations Major limitations were the limited size of the groups studied and the differences between the groups in frequency and duration of physical therapy sessions . Conclusion Extending the r and omized trial with process evaluation was needed to obtain insight into associations between the components of intervention and developmental outcome . Specific therapist behaviors of parent coaching are associated with improved developmental outcome measures . Further studies are needed to examine whether these associations are caused by therapist behavior or whether therapist behavior is modified by children 's motor skills People living with HIV/AIDS who have lower health literacy show poorer treatment adherence and more adverse health outcomes . The authors undertook the development and pilot testing of a brief HIV treatment adherence improvement counseling intervention for people with lower health literacy who were taking antiretroviral medications . Guided by a theory of health behavior change , health education principles for lower literacy population s , and formative research , the authors design ed a two-session plus one booster session nurse-delivered HIV treatment adherence intervention . Results from a pilot test with 30 HIV-positive men and women with lower health literacy showed that the intervention increased HIV/AIDS knowledge , intentions to improve adherence , and self-efficacy for adhering to medications . Participants exposed to the intervention also showed improvement in medication adherence , with reductions in numbers of missed pills and reductions in numbers of doses taken off-schedule . These results suggest that relatively brief behavioral interventions that are tailored for people with lower health literacy may have a significant impact on health-related behaviors Study Design . Pragmatic , r and omized , assessor blinded , clinical trial with economic analysis . Objective . To compare the effectiveness and cost-effectiveness of three kinds of physiotherapy commonly used to reduce disability in chronic low back pain . Summary of Background Data . Physiotherapy reduces disability in chronic back pain , but there are several forms of physiotherapy and it is unclear which is most effective or cost effective . Methods . A total of 212 patients referred to physiotherapy with chronic low back pain were r and omized to  receive usual outpatient physiotherapy , spinal stabilization classes , or physiotherapist-led pain management classes . Primary outcome was Rol and Disability Question naire score 18 months from baseline ; secondary measures were pain , health-related quality of life , and time off work . Healthcare costs associated with low back pain and quality -adjusted life years ( QALYs ) were also measured . Results . A total of 71 participants were assigned to usual outpatient physiotherapy , 72 to spinal stabilization , and 69 to physiotherapist-led pain management . A total of 160 ( 75 % ) provided follow-up data at 18 months , showing similar improvements with all interventions : mean ( 95 % confidence intervals ) Rol and Disability Question naire score improved from 11.1 ( 9.6–12.6 ) to 6.9 ( 5.3–8.4 ) with usual outpatient physiotherapy , 12.8 ( 11.4−14.2 ) to 6.8 ( 4.9–8.6 ) with spinal stabilization , and 11.5 ( 9.8–13.1 ) to 6.5 ( 4.5–8.6 ) following pain management classes . Pain , quality of life , and time off work also improved within all groups with no between-group differences . Mean ( SD ) healthcare costs and QALY gain were £ 474 ( 840 ) and 0.99 ( 0.27 ) for individual physiotherapy , £ 379 ( 1040 ) and 0.90 ( 0.37 ) for spinal stabilization , and £ 165 ( 202 ) and 1.00 ( 0.28 ) for pain management . Conclusions . For chronic low back pain , all three physiotherapy regimens improved disability and other relevant health outcomes , regardless of their content . Physiotherapist-led pain management classes offer a cost-effective alternative to usual outpatient physiotherapy and are associated with less healthcare use . A more widespread adoption of physiotherapist-led pain management could result in considerable cost savings for healthcare providers Introduction 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 r and omised controlled trials ( RCTs ) provide the foundation of evidence that vali date s 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 ) . Methods and analysis 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 , research ers , 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 . Ethics and dissemination Given that over 30 novel therapeutic compounds are in development for IBD treatment , the design of robust clinical trials measuring relevant and st and ardised outcomes is crucial . St and ardising outcomes through a COS will reduce heterogeneity in trial reporting , facilitate valid comparisons of new therapies and improve clinical trial quality Background The European Academy of Allergy and Clinical Immunology is developing guidelines about how to prevent and manage food allergy . As part of the guidelines development process , a systematic review is planned to examine published research about the prevention of food allergy . This systematic review is one of seven inter-linked evidence syntheses that are being undertaken in order to provide a state-of-the-art synopsis of the current evidence base in relation to epidemiology , prevention , diagnosis and clinical management , and impact on quality of life , which will be used to inform clinical recommendations . The aim of this systematic review will be to assess the effectiveness of approaches for the primary prevention of food allergy . Methods Seven bibliographic data bases will be search ed from their inception to September 30 , 2012 for systematic review s , r and omized controlled trials , quasi-r and omized controlled trials , controlled clinical trials , controlled before- and -after studies , interrupted time series and cohort studies . Cohort studies will be included due to an inability to r and omize with interventions such as breastfeeding . Studies that focused on the development of either food sensitization ( a proxy measure ) or food allergy will also be eligible for inclusion . Studies will be critically appraised using the Critical Appraisal Skills Program and Cochrane Risk of Bias tools , as appropriate . Discussion There is a lack of rigorous evidence to support recommendations about how to prevent the development of food allergy . It would appear that it is important to see the prevention of food allergy in the context of individual , family and wider factors that may influence its development . There is much left to learn about preventing food allergy , and this is a priority given the high societal and healthcare costs involved . This systematic review will help to further this learning Trust and confidence are critical to the success of health care models . There are two main methods for achieving this : transparency ( people can see how the model is built ) and validation ( how well the model reproduces reality ) . This report describes recommendations for achieving transparency and validation developed by a taskforce appointed by the International Society for Pharmacoeconomics and Outcomes Research and the Society for Medical Decision Making . Recommendations were developed iteratively by the authors . A nontechnical description -- including model type , intended applications , funding sources , structure , intended uses , inputs , outputs , other components that determine function , and their relationships , data sources , validation methods , results , and limitations --should be made available to anyone . Technical documentation , written in sufficient detail to enable a reader with necessary expertise to evaluate the model and potentially reproduce it , should be made available openly or under agreements that protect intellectual property , at the discretion of the modelers . Validation involves face validity ( wherein experts evaluate model structure , data sources , assumptions , and results ) , verification or internal validity ( check accuracy of coding ) , cross validity ( comparison of results with other models analyzing the same problem ) , external validity ( comparing model results with real-world results ) , and predictive validity ( comparing model results with prospect ively observed events ) . The last two are the strongest form of validation . Each section of this article contains a number of recommendations that were iterated among the authors , as well as among the wider modeling taskforce , jointly set up by the International Society for Pharmacoeconomics and Outcomes Research and the Society for Medical Decision Making
Conclusion Our findings suggest that people with low literacy skills or learning disabilities are left out of the development of PROMs .
Background  Patient-reported outcome measures ( PROMs ) are intended to reflect outcomes relevant to patients .
They are increasingly used for healthcare quality improvement .
To produce valid measures , patients should be involved in the development process but it is unclear whether this usually includes people with low literacy skills or learning disabilities .