bluuebunny/crossref_metadata_2025_split huggingface dataset:
Promoting healthy eating in nursery schoolchildren: A quasi-experimental intervention study
Authors: Korwanich Kanyarat , Sheiham Aubrey , Srisuphan Wichit , Srisilapanan Patcharawan 
Published: February 2008

Objective To evaluate the effects of implementing a healthy eating policy on nursery schoolchildren's dietary practices in nurseries in Phrae Province, Thailand. Design Quasi-experimental action research was used to compare the effects of school healthy eating policy on the diets of nursery schoolchildren in eight intervention and eight matched control schools. Setting Sample was 219 nursery schoolchildren aged four to five years attending 16 schools in Muang district, Phrae Province, Thailand. Method School healthy eating policy was implemented in intervention schools with the active participation of the school board members, teachers and parents. Snack intakes of 219 nursery schoolchildren in intervention and control groups were assessed through direct observation by trained observers and a three-day dietary record. Dietary data on snack consumption was collected at baseline and nine months after implementing a healthy eating policy. Results After nine months, the consumption of every snack item, except non-sugar milk, decreased significantly in intervention schools compared to the baseline ( p < .05), but not in control schools. In intervention schools the mean frequency of intakes per day decreased for cariogenic snacks, fresh fruits, Thai desserts, crispy snacks and sugary drinks. On the other hand, in control schools, the mean frequency of consumption per day of cariogenic snacks, non-sugar milk and crispy snacks increased significantly ( p < .05). In the control schools, no difference was found between baseline and after nine months in consumption of fresh fruit, Thai desserts and sugary drinks consumption. Conclusion Healthy eating policy for nursery schoolchildren was effective in reducing snack consumption in intervention schools.
Support and education of immigrants with chronically ill children: Identified needs from a case study of Turkish and Kurdish families
Authors: Povlsen Lene , Karlberg Ingvar , Ringsberg Karin C 
Published: February 2008

Objective The aim of the study was to analyse how parents of Turkish and Turkish/Kurdish children with diabetes and health care professionals perceived the education and support provided, and to assess what was required to improve the collaboration between the families and the team in order to optimize selfcare and metabolic control. Design A case study including semi-structured interviews, participant observation and information from medical records. Setting The study was carried out in Copenhagen, Denmark. Method The study included 11 children aged 4—17 years of Turkish and Kurdish origin, their parents, the Turkish interpreter and the paediatric diabetes team. Results The study identified the following factors that might contribute to improve the outcome: 1) Adjusted educational initiatives to promote a better understanding of concepts like chronic disease and selfcare, and to ensure that the content of the education is understood, implemented and maintained; 2) special support to enable parents to deal with practical and emotional problems and conflicts related to diabetes management; 3) closer contact and psychosocial support in order to promote learning and motivation for selfcare as well as promoting attendance at the clinics. Conclusion Non-western immigrants have a considerable need for special support to help them learn to manage a chronic disease. Health education should aim at bridging the gap between differences related to culture and traditions.
Sustainable participation in regular exercise amongst older people: Developing an action research approach
Authors: Davies Jeanne , Lester Carolyn , O'Neill Martin , Williams Gareth 
Published: February 2008

Objective This article describes the Triangle Project's work with a post industrial community, where healthy living activities were developed in response to community members' expressed needs. Method An action research partnership approach was taken to reduce health inequalities, with local people developing their own activities to address health and well being issues. At the instigation of older women attending a community consultation, a low intensity exercise class was started. Baseline details including weight, self-assessed fitness and mobility problems were recorded. The class branched out into social activities including healthy eating, walks and outings; members controlling the pace and content of both class and spin-off activities via continuous feedback and discussion with the Triangle researcher. Two evaluation events were held using a focus group format. Findings Barriers to regular participation are discussed, together with the achievement of a sustainable fitness group with evidence of health improvement in an initially `unfit' group. Social aspects were highly valued by participants and contributed to sustainability of the class, which is now run by members without external input. Limitations Though activities appeared to be sustainable when the Triangle Project ended, no longer term follow-up has been possible due to cessation of funding. Implications Projects aiming to achieve sustainability should build in provision for longer term follow-up.
Vaccination coverage among kindergarten children in Phoenix, Arizona
Authors: Frimpong Jemima A , Rivers Patrick A , Bae Sejong 
Published: February 2008

Objective To evaluate school immunization records and document the immunization coverage and compliance level of children enrolled in kindergarten in Phoenix during the 2001—2002 school year. The purpose was to obtain information on: 1) immunization status by age two; 2) under-immunization in kindergarten; 3) administration error; and 4) transcription error. Methods Vaccination levels were estimated by conducting a retrospective immunization coverage survey of the immunization records of children in SW, SE, NE, and NW regions of Phoenix. A two-stage cluster design was used. Schools were randomly selected with the regions and students were systematically selected within the schools. Setting Twelve schools from Phoenix were surveyed. Immunization records for 865 student records were assessed. Children who had incomplete or unknown records were identified. Information on date of birth and dates of vaccination of each dose of vaccine was collected. Results Of the 857 records included in the analyses, 30.6 per cent were from the NE, 19.9 per cent from the NW, 17.8 per cent from the SE and 31.7 per cent were from the SW. Private school students comprised 18.4 per cent of the sample, 78.3 per cent were from public schools and 3.4 per cent from charter schools. Examining the sample, 30.5 per cent did not have the shots required by age two (four Dtap, three Polio, one MMR), 11.4 per cent of shots were administered before the minimum age and/or interval, 16.0 per cent did not have the shots required for entrance to kindergarten (four Dtap, three Polio, two MMR, three HEP B) and 10.8 per cent of the records contained transcription errors. Conclusion The data showed that vaccination rates varied by region. None of the schools were in full compliance with the Arizona goal of 95 per cent of all kindergarten students being up to date. The vaccination levels were also below the National 2010 goal of 90 per cent by age two. The high administration error rate indicates that providers need to administer vaccines according to the recommended schedule. Further assessment must be done to determine effective interventions to target specific populations.
Business Information Survey
Authors: Foster Allan 
Published: February 2008

Survey of business information services in corporate information services, based on in-depth interviews with leading business information managers. Key findings are: • Business information budgets have been stable, with at least inflationary increases built in • Business conditions have been turbulent of late but this has had no real impact on the services to date • With more information rolled out to the clients' desktops, the services are all working to add value through a variety of approaches, including training, evaluation and analysis, business and client development, and generally undertaking more complex work • Some pressure on the staffing headcount in the services during the year • Recruiting suitable information professionals is a difficult process • Offshoring information and research work has not expanded significantly but more companies are considering this option • `Techno-centric' knowledge management remains important in some companies, particularly law firms, but is fading as a practice in others • There is great interest and envisaged potential in social technology and Web 2.0 tools and techniques — but not much serious deployment yet • Even in mature corporate information environments, marketing business information services is still seen as crucial by 90 per cent of respondents • Fifty-five percent of the services provide some kind of competitor information function, albeit not at a high level • A significant majority (75 per cent) of services support compliance functions such as `Know your client' and anti-money laundering checks • Existing copyright provisions are seen as a barrier to effective information dissemination within companies by 80 per cent of respondents • LexisNexis takes over at the top of the expenditure league • The demand for information on Asian business markets is growing • Almost all services are committed to training users in the discovery and use of digital business information sources • The organization, management, and sometimes realignment of services is the highest strategic priority.
Internet-based monitoring of asthma symptoms, peak flow meter readings, and absence data in a school-based clinical trial
Authors: McClure Leslie A , Harrington Kathy F , Graham Holli , Gerald Lynn B 
Published: February 2008

Background Asthma is the most common chronic childhood disease and has significant impact on morbidity and mortality in children. Proper adherence to asthma medication has been shown to reduce morbidity among those with asthma; however, adherence to medications is known to be low, especially among low-income urban populations. We conducted a randomized clinical trial to examine the effectiveness of an intervention designed to increase adherence to asthma medication among children with asthma that required daily collection of data. Purpose and Methods A specifically designed web-based data collection system, the Asthma Agents System, was used to collect daily data from participant children at school. These data were utilized to examine the intervention's effectiveness in reducing the frequency of asthma exacerbations. This study examines the Asthma Agents System's effect on the frequency of missing data. Data collection methods are discussed in detail, as well as the processes for retrieving missing data. Results For the 290 children randomized, 97% of the daily data expected were available. Of the outcome data retrieved via the Asthma Agents System, 5% of those expected were missing during the period examined. Limitations Challenges encountered in this study include issues regarding the use of technology in urban school settings, transfer of data between study sites, and availability of data during school breaks. Conclusions Use of the Asthma Agents System resulted in lower rates of missing data than rates reported elsewhere in the literature. Clinical Trials 2008; 5: 31—37. http://ctj.sagepub.com
Interim futility analysis with intermediate endpoints
Authors: Goldman Bryan , LeBlanc Michael , Crowley John 
Published: February 2008

Background Interim analysis of Phase III trials typically includes testing for both efficacy and futility. Futility testing is commonly performed on the primary outcome at very low levels (e.g., one-sided α=0.0025) at one or two times before final analysis. When overall survival is the primary outcome and events accrue slowly, and if a suitable intermediate endpoint is available, then using this endpoint for interim futility testing may yield a higher probability of stopping early for futility in the absence of any treatment effect. Purpose The purpose of this study is to explore the possibility of incorporating an intermediate endpoint into interim futility testing of Phase III trials. Methods Using a simple two-stage exponential survival model based on recent Southwest Oncology Group Phase III studies in several disease settings, we perform a series of simulation studies. Survival data are simulated under both the null and alternative hypotheses, and analyzed using overall survival, progression-free survival, and a composite endpoint for futility testing. Results In all disease settings examined here, when survival data were simulated under the null hypothesis, the probability of stopping a trial early for futility was substantially increased by incorporating PFS into interim futility analyses. When testing for futility with the composite endpoint, average patient accrual was reduced by 6—11% in a wide variety of disease settings. In the study scenario with the longest survival, the savings in study duration was more dramatic than in patient resources. When data were simulated under the alternative hypothesis, this procedure resulted in a negligible loss of power. Limitations The properties of this procedure outside of the context of cancer clinical trials and/or using a different intermediate endpoint are not examined. These results also do not address its performance in the context of less conservative stopping rules. Conclusions Interim futility monitoring of Phase III trials using a suitable intermediate endpoint may substantially increase the probability of stopping early for futility when there is no treatment effect. These simulation studies suggest that this would lead to meaningful reductions in study duration and patient resources in many disease settings, with no substantial loss of power for the primary test of efficacy. Future work is needed to explore in detail whether modifications to the stopping rules used in this procedure may yield greater savings without compromising power. Clinical Trials 2008; 5: 14—22. http://ctj.sagepub.com
Sensible approaches for reducing clinical trial costs
Authors: Eisenstein Eric L , Collins Rory , Cracknell Beena S , Podesta Oscar , Reid Elizabeth D , Sandercock Peter , Shakhov Yuriy , Terrin Michael L , Sellers Mary Ann , Califf Robert M , Granger Christopher B , Diaz Rafael 
Published: February 2008

Background Over the past decade, annual funding for biomedical research has more than doubled while new molecular entity approvals have declined by one third. Objective To assess the value of practices commonly employed in the conduct of large-scale clinical trials, and to identify areas where costs could be reduced without compromising scientific validity. Methods In the qualitative phase of the study, an expert panel recommended potential modifications of mega-trial designs and operations in order to maximize their value (cost versus scientific benefit tradeoff). In the quantitative phase, a mega-trial economic model was used to assess the financial implications of these recommendations. Our initial chronic disease trial design included 20,000 patients randomized at 1000 sites. Each site was assigned 24 monitoring visits and a $10,000 per patient site payment. The case report form (CRF) was 60 pages long, and trial duration was assumed to be 48 months. Results The total costs of the initial trial design were $421 million ($US 2007). Following the expert panel's recommendations, we varied study duration, CRF length, number of sites, electronic data capture (EDC), and site management components to determine their individual and combined effects upon total trial costs. The use of EDC and modified site management practices were associated with significant reductions in total trial costs. When reductions in all five trial components were combined in a streamlined pharmaceutical industry design, a 59% reduction in total trial costs resulted. When we assumed an even more streamlined trial design than has typically been considered for regulatory submissions in the past, there was a 90% reduction in total trial costs. Conclusion Our results suggest that it is possible to reduce substantially the cost of large-scale clinical trials without compromising the scientific validity of their results. If implemented, our recommendations could free billions of dollars annually for additional clinical studies. Research in the setting of clinical trials should be conducted to refine these findings. Clinical Trials 2008; 5: 75—84. http:// ctj.sagepub.com
The impact of privacy and confidentiality laws on the conduct of clinical trials
Authors: Armitage Jane , Souhami Robert , Friedman Lawrence , Hilbrich Lutz , Holland Jack , Muhlbaier Lawrence H. , Shannon Jane , Van Nie Alison 
Published: February 2008

Justifiable concerns about the use of personal data in many aspects of daily life have led to the recent introduction in many countries of laws intended to regulate data use. Although participation in randomized clinical trials is generally with informed consent, recruitment procedures, complete follow-up, and the efficient conduct of trials may be substantially affected by such national or local privacy legislation. The relevant laws often have exceptions that allow the use of patient information in the public interest — including the use of data collected to improve or monitor public health or as part of medical research. However, regulatory bodies often give conflicting interpretations of the law, and this affects the conduct of large-scale trials. In particular, unnecessarily restrictive interpretation of the law may be a serious impediment to identification of potential participants for a trial, access to records to confirm events, continued follow-up of patients after the trial has been concluded, and secondary use of the trial data for purposes not directly related to the original purpose of the study. These obstacles could be overcome by better informing patients of the uses of records for medical research purposes, by using informed consent procedures that explain the nature of the research and the uses of the data, and by the use of identifiers, such as social security numbers that allow central follow-up. The clinical trial research community needs to ensure that the substantial benefits of large-scale randomized trials are explained both to the public and to those responsible for introducing legislation. The negative impact of privacy legislation on the use of personal health information and on conducting large studies needs to be understood and minimized. Clinical Trials 2008; 5: 70—74. http://ctj.sagepub.com
Estimating effects from randomized trials with discontinuations: the need for intent-to-treat design and G-estimation
Authors: Greenland Sander , Lanes Stephan , Jara Michele 
Published: February 2008

Background Randomized trials provide pivotal evidence for evaluation and approval of therapies. Nonetheless, such trials are often plagued by noncompliance, especially in the form of premature discontinuation of treatment. While intent-to-treat (ITT) analysis can provide valid tests of no-effect hypotheses, some trials may make ITT analysis impossible by ceasing follow-up when patients go off assigned treatment. Furthermore, estimates based on ITT, on-treatment, or per-protocol comparisons can seriously understate harm or benefit. Purpose To show how g-estimation based on randomization status is a natural generalization of ITT null testing to estimating efficacy from trials with important discontinuation or noncompliance. Methods We contrast with an analysis of the effect of a tiotropium inhaler on the occurrence of chronic obstructive pulmonary disease (COPD) events in a six-month double-blind placebo-controlled trial of 1829 patients with good but imperfect compliance. Results The covariate-adjusted point estimates, 95% confidence limits (CL), and null P-values comparing expected COPD event times in placebo versus tiotropium patients were: ITT, 1.21, CL = 1.02, 1.43, P = 0.027; on-treatment, 1.27, CL = 1.06, 1.52, P = 0.009; per-protocol, 1.36, CL = 1.13, 1.63, P = 0.001; and g-estimation, 1.31, CL = 1.03,1.72, P = 0.027. Thus g-estimation preserved the ITT test of the null, but exhibited more uncertainty about the size of the tiotropium effect than the other methods. In particular, it allowed for a much larger potential effect than did ITT analysis, but produced a much larger null P than exhibited by per-protocol analysis. Limitations Like ITT analysis, g-estimation requires all patients be followed to the end of the trial protocol, regardless of whether they comply with the protocol. Like on-treatment and per-protocol analyses, it also requires accurate compliance information be recorded. Conclusion G-estimation should become a standard procedure for the analysis of trials with noncompliance. Software to do so is available in major packages, and the procedure is easily coded for other packages. Clinical Trials 2008; 5: 5—13. http://ctj.sagepub.com
Specific barriers to the conduct of randomized trials
Authors: Duley Lelia , Antman Karen , Arena Joseph , Avezum Alvaro , Blumenthal Mel , Bosch Jackie , Chrolavicius Sue , Li Timoa , Ounpuu Stephanie , Perez Analia Cristina , Sleight Peter , Svard Robbyna , Temple Robert , Tsouderous Yannis , Yunis Carla , Yusuf Salim 
Published: February 2008

Large randomized trials are required to provide reliable evidence of the typically moderate benefit of most interventions. To be affordable, such trials need to be simple; to be widely applicable, they need to be close to normal clinical practice. However, current regulations and guidelines have hugely increased trial complexity, effectively becoming barriers to their design and conduct. Key barriers include inadequate funding, overly complex regulations producing needlessly complex trial procedures, excessive monitoring, over restrictive interpretation of privacy laws without evidence of subject benefit, and inadequate understanding of methodology. Complex regulations result in multiple ethics approvals for a multi-center study, unnecessary complexity in the study protocol, delays in securing regulatory approval, and cumbersome regulatory procedures, even for drugs widely used in clinical practice. The type of detailed safety monitoring currently needed in trials of new drugs is being applied indiscriminately to all studies including a simpler and basic level of monitoring that constitutes good practice in most trials could be agreed on, with that level being exceeded only in specific instances. More evidence about the pros and cons of alternative approaches to data quality monitoring would help inform this process. Complex procedures in the form of multiple-page consent forms, overzealous monitoring of side effects and adverse events, source data verification, and over-restrictive approaches to protocol amendments, can impede, rather than facilitate, trial objectives. Finally, further education on the nuances and functions of randomisation would facilitate trial conduct, and reduce the need for burdensome complexity. A radical re-evaluation of existing trial guidelines is needed, based on a clear understanding of the important principles of randomized trials, with the objective of eliminating unnecessary documentation and reporting without sacrificing validity or safety. Researchers should encourage public debate about how best to strike the balance between regulation and cost. Clinical Trials 2008; 5: 40—48. http://ctj.sagepub.com