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1.  Cytotoxicity and genotoxicity caused by yttrium oxide nanoparticles in HEK293 cells 
Background
The increased use of engineered nanoparticles (NPs) has caused new concerns about the potential exposure to biological systems and the potential risk that these materials may pose on human health. Here, we examined the effects of exposure to different concentrations (0–50 μg/mL) and incubation times (10 hours, 24 hours, or 48 hours) of yttrium oxide (Y2O3) NPs on human embryonic kidney (HEK293) cells. Changes in cellular morphology, cell viability, cell membrane integrity, reactive oxygen species levels, mitochondrial membrane potential, cell death (apoptosis and necrosis), and the DNA damage after NP exposure were compared to the effects seen following incubation with paraquat, a known toxicant.
Results
The 24-hour inhibitory concentration 50 (IC50) of Y2O3 NPs (41±5 nm in size) in the HEK293 cells was found to be 108 μg/mL. Incubation with Y2O3 NPs (12.25–50 μg/mL) increased the ratio of Bax/Bcl-2, caspase-3 expression and promoted apoptotic- and necrotic-mediated cell death in both a concentration and a time-dependent manner. Decreases in cell survivability were associated with elevations in cellular reactive oxygen species levels, increased mitochondrial membrane permeability, and evidence of DNA damage, which were consistent with the possibility that mitochondria impairment may play an important role in the cytotoxic response.
Conclusion
These data demonstrate that the Y2O3 NP exposure is associated with increased cellular apoptosis and necrosis in cultured HEK293 cells.
doi:10.2147/IJN.S52625
PMCID: PMC3958544  PMID: 24648735
yttrium oxide nanoparticles; cytotoxicity; mitochondria damage; DNA damage; ROS production; apoptosis; necrosis
2.  Evaluating the implementation of HeLP-Diabetes within NHS services: study protocol 
Background
Self-management by people with type 2 diabetes is central to good health outcomes and the prevention of associated complications. Structured education to teach self-management is recommended by the National Institute for Heath and Clinical Excellence; however, only a small proportion of patients report being offered this education and even fewer attend. This study aims to evaluate the implementation of a new internet-based self-management intervention: HeLP-Diabetes (Healthy Living for People with type 2 Diabetes) within the National Health Service. Specific objectives are to a) determine the uptake and use of HeLP-Diabetes by services and patients; b) identify the factors which inhibit or facilitate use; c) identify the resources needed for effective implementation; d) explore possible effects of HeLP-Diabetes use on self-reported patient outcome measures.
Methods/Design
This study will use an iterative design to implement HeLP-Diabetes into existing health services within the National Health Service. A two stage implementation process will be taken, whereby batches of General Practice surgeries and diabetes clinics will be offered HeLP-Diabetes and will subsequently be asked to participate in evaluating the implementation. We will collect data to describe the number of services and patients who sign up to HeLP-Diabetes, the types of services and patients who sign up and the implementation costs. Semi-structured interviews will be conducted with patients and health professionals and cohorts of patient participants will be asked to complete self-report measures at baseline, 3 months, and 12 months.
Discussion
This study will evaluate the implementation of a new online self-management intervention and describe what happens when it is made available to existing National Health Services and patients with type 2 diabetes. We will collect data to describe the uptake and use of the intervention and the resources needed for widespread implementation. We will report on patient benefits from using HeLP-Diabetes and the resources needed to achieve these in routine practice. Interviews with key stake holders will identify, define and explain factors that promote or inhibit the normalization of new patterns of patient and professional activity arising from HeLP-Diabetes.
doi:10.1186/1472-6963-14-51
PMCID: PMC3915558  PMID: 24495515
Implementation; Diabetes; Health services research; Internet; Self-management
3.  Stepwise Self-Titration of Oral Glucose-Lowering Medication Using a Mobile Telephone-Based Telehealth Platform in Type 2 Diabetes: A Feasibility Trial in Primary Care 
Background
Telehealth-supported clinical interventions may improve diabetes self-management. We explored the feasibility of stepwise self-titration of oral glucose-lowering medication guided by a mobile telephone-based telehealth platform for improving glycemic control in type 2 diabetes.
Methods
We recruited 14 type 2 diabetes patients to a one-year feasibility study with 1:1 randomization. Intervention group patients followed a stepwise treatment plan for titration of oral glucose-lowering medication with self-monitoring of glycemia using real-time graphical feedback on a mobile telephone and remote nurse monitoring using a Web-based tool. We carried out an interim analysis at 6 months.
Results
We screened 3476 type 2 diabetes patients; 94% of the ineligible did not meet the eligibility criteria for hemoglobin A1c (HbA1c) or current treatment. Mean (standard deviation) patient age at baseline was 58 (11) years, HbA1c was 65 (12) mmol/mol (8.1% [1.1%]), body mass index was 32.9 (6.4) kg/m2, median [interquartile range (IQR)] diabetes duration was 2.6 (0.6 to 4.7) years, and 10 (71%) were men. The median (IQR) change in HbA1c from baseline to six months was -10 (-21 to 3) mmol/mol (-0.9% [-1.9% to 0%]) in the intervention group and -5 (-13 to 6) mmol/mol (-0.5% [-1.2% to 0.6%]) in the control group. Six out of seven intervention group patients and four out of seven control group patients changed their oral glucose-lowering medication (p = .24).
Conclusions
Self-titration of oral glucose-lowering medication in type 2 diabetes with self-monitoring and remote monitoring of glycemia is feasible, and further studies using adapted recruitment strategies are required to evaluate whether it improves clinical outcomes.
PMCID: PMC3692224  PMID: 23439168
oral glucose-lowering medication; self-monitoring of blood glucose; self-titration; telehealth; type 2 diabetes
4.  The Sexunzipped Trial: Young People’s Views of Participating in an Online Randomized Controlled Trial 
Background
Incidence of sexually transmitted infections (STIs) among young people in the United Kingdom is increasing. The Internet can be a suitable medium for delivery of sexual health information and sexual health promotion, given its high usage among young people, its potential for creating a sense of anonymity, and ease of access. Online randomized controlled trials (RCTs) are increasingly being used to evaluate online interventions, but while there are many advantages to online methodologies, they can be associated with a number of problems, including poor engagement with online interventions, poor trial retention, and concerns about the validity of data collected through self-report online. We conducted an online feasibility trial that tested the effects of the Sexunzipped website for sexual health compared to an information-only website. This study reports on a qualitative evaluation of the trial procedures, describing participants’ experiences and views of the Sexunzipped online trial including methods of recruitment, incentives, methods of contact, and sexual health outcome measurement.
Objective
Our goal was to determine participants’ views of the acceptability and validity of the online trial methodology used in the pilot RCT of the Sexunzipped intervention.
Methods
We used three qualitative data sources to assess the acceptability and validity of the online pilot RCT methodology: (1) individual interviews with 22 participants from the pilot RCT, (2) 133 emails received by the trial coordinator from trial participants, and (3) 217 free-text comments from the baseline and follow-up questionnaires. Interviews were audio-recorded and transcribed verbatim. An iterative, thematic analysis of all three data sources was conducted to identify common themes related to the acceptability and feasibility of the online trial methodology.
Results
Interview participants found the trial design, including online recruitment via Facebook, online registration, email communication with the researchers, and online completion of sexual health questionnaires to be highly acceptable and preferable to traditional methods. Incentives might assist in recruiting those who would not otherwise participate. Participants generally enjoyed taking part in sexual health research online and found the questionnaire itself thought-provoking. Completing the sexual health questionnaires online encouraged honesty in responding that might not be achieved with other methods. The majority of interview participants also thought that receiving and returning a urine sample for chlamydia testing via post was acceptable.
Conclusions
These findings provide strong support for the use of online research methods for sexual health research, emphasizing the importance of careful planning and execution of all trial procedures including recruitment, respondent validation, trial related communication, and methods to maximize follow-up. Our findings suggest that sexual health outcome measurement might encourage reflection on current behavior, sometimes leading to behavior change.
Trial Registration
International Standard Randomized Controlled Trial Number (ISRCTN): 55651027; http://www.controlled-trials.com/isrctn/pf/55651027 (Archived by WebCite at http://www.webcitation.org/6LbkxdPKf).
doi:10.2196/jmir.2647
PMCID: PMC3868966  PMID: 24334198
Internet; randomized controlled trials; qualitative research; outcome assessment (health care); sexual health; chlamydia trachomatis
5.  The Sexunzipped Trial: Optimizing the Design of Online Randomized Controlled Trials 
Background
Sexual health problems such as unwanted pregnancy and sexually transmitted infection are important public health concerns and there is huge potential for health promotion using digital interventions. Evaluations of digital interventions are increasingly conducted online. Trial administration and data collection online offers many advantages, but concerns remain over fraudulent registration to obtain compensation, the quality of self-reported data, and high attrition.
Objective
This study addresses the feasibility of several dimensions of online trial design—recruitment, online consent, participant identity verification, randomization and concealment of allocation, online data collection, data quality, and retention at 3-month follow-up.
Methods
Young people aged 16 to 20 years and resident in the United Kingdom were recruited to the “Sexunzipped” online trial between November 2010 and March 2011 (n=2036). Participants filled in baseline demographic and sexual health questionnaires online and were randomized to the Sexunzipped interactive intervention website or to an information-only control website. Participants were also randomly allocated to a postal request (or no request) for a urine sample for genital chlamydia testing and receipt of a lower (£10/US$16) or higher (£20/US$32) value shopping voucher compensation for 3-month outcome data.
Results
The majority of the 2006 valid participants (90.98%, 1825/2006) were aged between 18 and 20 years at enrolment, from all four countries in the United Kingdom. Most were white (89.98%, 1805/2006), most were in school or training (77.48%, 1545/1994), and 62.81% (1260/2006) of the sample were female. In total, 3.88% (79/2036) of registrations appeared to be invalid and another 4.00% (81/2006) of participants gave inconsistent responses within the questionnaire. The higher value compensation (£20/US$32) increased response rates by 6-10%, boosting retention at 3 months to 77.2% (166/215) for submission of online self-reported sexual health outcomes and 47.4% (118/249) for return of chlamydia urine samples by post.
Conclusions
It was quick and efficient to recruit young people to this online trial. Our procedures for obtaining online consent, verifying participant identity, automated randomization, and concealment of allocation worked well. The optimal response rate for the online sexual health outcome measurement was comparable to face-to-face trials. Multiple methods of participant contact, requesting online data only, and higher value compensation increased trial retention at 3-month follow-up.
Trial Registration
International Standard Randomized Controlled Trial Number (ISRCTN): 55651027; http://www.controlled-trials.com/ISRCTN55651027 (Archived by WebCite at http://www.webcitation.org/6LbkxdPKf).
doi:10.2196/jmir.2668
PMCID: PMC3868980  PMID: 24334216
Internet; randomized controlled trials as topic; outcome assessment (health care); sexual health; sexually transmitted diseases; behavioral research
6.  ‘I need her to be a doctor’: patients’ experiences of presenting health information from the internet in GP consultations 
The British Journal of General Practice  2012;62(604):e732-e738.
Background
Patients are increasingly using the internet for health-related information and may bring this to a GP consultation. There is scant information about why patients do this and what they expect from their GP.
Aim
The aim was to explore patients’ motivation in presenting information, their perception of the GP’s response and what they wanted from their doctor.
Design and setting
Qualitative study based in North London involving patients with experience of bringing health information from the internet to their GP.
Method
Semi-structured face-to-face and telephone interviews using a critical incident technique, recorded, transcribed verbatim, and subjected to thematic analysis by a multidisciplinary team of researchers.
Results
Twenty-six interviews were completed. Participants reported using the internet to become better informed about their health and hence make best use of the limited time available with the GP and to enable the GP to take their problem more seriously. Patients expected their GP to acknowledge the information; discuss, explain, or contextualise it; and offer a professional opinion. Patients tended to prioritise the GP opinion over the internet information. However, if the GP appeared disinterested, dismissive or patronising patients reported damage to the doctor–patient relationship, occasionally to the extent of seeking a second opinion or changing their doctor.
Conclusion
This is the first in-depth qualitative study to explore why patients present internet information to their GP within the consultation and what they want when they do this. This information should help GPs respond appropriately in such circumstances.
doi:10.3399/bjgp12X658250
PMCID: PMC3481513  PMID: 23211176
family practice; internet; patient participation; physician–patient relations; qualitative research
7.  Attrition Revisited: Adherence and Retention in a Web-Based Alcohol Trial 
Background
Attrition is a noted feature of eHealth interventions and trials. In 2005, Eysenbach published a landmark paper calling for a “science of attrition,” suggesting that the 2 forms of attrition—nonusage attrition (low adherence to the intervention) and dropout attrition (poor retention to follow-up)—may be related and that this potential relationship deserved further study.
Objective
The aim of this paper was to use data from an online alcohol trial to explore Eysenbach’s hypothesis, and to answer 3 research questions: (1) Are adherence and retention related? If so, how, and under which circumstances? (2) Do adherence and retention have similar predictors? Can these predictors adequately explain any relationship between adherence and retention or are there additional, unmeasured predictors impacting on the relationship? (3) If there are additional unmeasured predictors impacting on the relationship, are there data to support Eysenbach’s hypothesis that these are related to overall levels of interest?
Methods
Secondary analysis of data from an online trial of an online intervention to reduce alcohol consumption among heavy drinkers. The 2 outcomes were adherence to the intervention measured by number of log-ins, and retention to the trial measured by provision of follow-up data at 3 months (the primary outcome point). Dependent variables were demographic and alcohol-related data collected at baseline. Predictors of adherence and retention were modeled using logistic regression models.
Results
Data were available on 7932 participants. Adherence and retention were related in a complex fashion. Participants in the intervention group were more likely than those in the control group to log in more than once (42% vs 28%, P<.001) and less likely than those in the control group to respond at 3 months (40% vs 49%, P<.001). Within each randomized group, participants who logged in more frequently were more likely to respond than those who logged in less frequently. Response rates in the intervention group for those who logged in once, twice, or ≥3 times were 34%, 46%, and 51%, respectively (P<.001); response rates in the control group for those who logged in once, twice, or ≥3 times were 44%, 60%, and 67%, respectively (P<.001). Relationships between baseline characteristics and adherence and retention were also complex. Where demographic characteristics predicted adherence, they tended also to predict retention. However, characteristics related to alcohol consumption and intention or confidence in reducing alcohol consumption tended to have opposite effects on adherence and retention, with factors that predicted improved adherence tending to predict reduced retention. The complexity of these relationships suggested the existence of an unmeasured confounder.
Conclusions
In this dataset, adherence and retention were related in a complex fashion. We propose a possible explanatory model for these data.
Trial Registration
International Standard Randomized Controlled Trial Number (ISRCTN): 31070347; http://www.controlled-trials.com/ISRCTN31070347 (Archived by WebCite at http://www.webcitation.org/6IEmNnlCn).
doi:10.2196/jmir.2336
PMCID: PMC3815435  PMID: 23996958
Internet; eHealth; attrition; adherence; retention; follow-up
8.  Health on the web: randomised trial of work-based online screening and brief intervention for hazardous and harmful drinking 
BMC Public Health  2013;13:505.
Background
Alcohol misuse is a significant international public health problem. Screening and brief intervention (SBI) in primary care reduces alcohol consumption by about 15 – 30%, sustained over 12 months in hazardous or harmful drinkers but implementation has proved difficult leading to growing interest in exploring the effectiveness of SBI in other settings, including the workplace. Computerised interventions for alcohol misuse can be as effective as traditional face-to-face interventions and may have advantages, including anonymity, convenience and availability.
Methods/design
Individually randomised controlled trial to determine the effectiveness and cost-effectiveness of offering online screening and brief intervention for alcohol misuse in a workplace. Participants: adults (aged 18 or over) employed by participating employers scoring 5 or more on a three item screen for alcohol misuse (the AUDIT-C) indicating possible hazardous or harmful alcohol consumption, recruited through the offer of an online health check providing screening for a range of health behaviours with personalised feedback. Participants who accept the health check and score 5 or more on the alcohol screen will be randomised to receiving immediate feedback on their alcohol consumption and access to an online intervention offering support in reducing alcohol consumption (Down Your Drink) or delayed feedback and access to Down Your Drink after completion of follow-up data at three months. All employees who take the online health check will receive personalised feedback on other screened health behaviours including diet, physical activity, smoking, and body mass index. The primary outcome is alcohol consumption in the past week at three months; secondary outcomes are the AUDIT, EQ-5D, days off work, number and duration of hospital admissions, costs and use of the intervention. A sample size of 1,472 participants (736 in each arm) provides 90% power with 5% significance to determine a 20% reduction in alcohol consumption. Outcomes between groups at three months will be compared following the intention to treat principle and economic analyses will follow NICE guidance.
Discussion
This innovative design avoids recruitment bias by not mentioning alcohol in the invitation and avoids reactivity of assessment by not collecting baseline data on alcohol consumption.
doi:10.1186/1471-2458-13-505
PMCID: PMC3671166  PMID: 23706155
Alcohol-related disorders; Alcohol; Screening and brief intervention; Internet; Randomised; Controlled trial; Workplace; Health promotion
9.  Predictors of Participant Retention in a Guided Online Self-Help Program for University Students: Prospective Cohort Study 
Background
Attrition is a persistent issue in online self-help programs, but limited research is available on reasons for attrition or successful methods for improving participant retention. One potential approach to understanding attrition and retention in such programs is to examine person-related variables (eg, beliefs and attitudes) that influence behavior. Theoretical models, such as the Theory of Planned Behavior, that describe conditions influencing human behavior may provide a useful framework for predicting participant retention in online-based program.
Objective
We examined predictors of participant retention in a guided online anxiety, depression, and stress self-help program for university students using the theory of planned behavior. We also explored whether age, symptom severity, and type of coaching (ie, email vs phone) affected participant retention.
Methods
65 university students with mild to moderate depression, anxiety, and stress were enrolled in this prospective cohort study. Participants completed a questionnaire based on the theory of planned behavior prior to commencing the online-based program and the Depression Anxiety and Stress Scale (DASS) during the assessment module of the program. Participant retention was operationalized as the number of program modules completed.
Results
Perceived control over completing the online program significantly predicted intention to complete the program (F 3,62=6.7; P=.001; adjusted R 2=.2; standardized beta=.436, P=.001). Age (standardized beta=.319, P=.03) and perceived behavioral control (standardized beta=.295, P=.05) predicted the number of program modules completed (F 3,61=3.20, P=.03, adjusted R 2 =.11). Initial level of distress (ie, symptom severity) did not predict participant retention (P=.55). Participants who chose phone-based coaching completed more program modules than participants who chose email-based coaching (Mann-Whitney’s U=137; P=.004).
Conclusions
Participants’ age, level of perceived behavioral control, and choice of interaction (ie, phone-based or email-based coaching) were found to influence retention in this online-based program.
doi:10.2196/jmir.2323
PMCID: PMC3668607  PMID: 23697614
self-help; online treatment; Web-based; retention; dropouts; theory of planned behavior
10.  Is adjuvant chemotherapy of benefit for postmenopausal women who receive endocrine treatment for highly endocrine-responsive, node-positive breast cancer? International Breast Cancer Study Group Trials VII and 12-93 
Purpose
To compare the efficacy of chemoendocrine treatment with that of endocrine treatment (ET) alone for postmenopausal women with highly endocrine responsive breast cancer.
Patients and methods
In the International Breast Cancer Study Group (IBCSG) Trials VII and 12-93, postmenopausal women with node-positive, estrogen receptor (ER)-positive or ER-negative, operable breast cancer were randomized to receive either chemotherapy or endocrine therapy or combined chemoendocrine treatment. Results were analyzed overall in the cohort of 893 patients with endocrine-responsive disease, and according to prospectively-defined categories of ER, age and nodal status. STEPP analyses assessed chemotherapy effect. The median follow-up was 13 years.
Results
Adding chemotherapy reduced the relative risk of a disease-free survival event by 19% (p=0.02) compared with ET alone. STEPP analyses showed little effect of chemotherapy for tumors with high levels of ER expression (p = 0.07), or for the cohort with one positive node (p = 0.03).
Conclusions
Chemotherapy significantly improves disease-free survival for postmenopausal women with endocrine-responsive breast cancer, but the magnitude of the effect is substantially attenuated if ER levels are high.
doi:10.1007/s10549-008-0225-9
PMCID: PMC3589110  PMID: 18953651
breast cancer; chemoendocrine therapy; estrogen receptors; postmenopausal
12.  Integrating Psychological Theory Into the Design of an Online Intervention for Sexual Health: The Sexunzipped Website 
JMIR Research Protocols  2012;1(2):e16.
Background
The Internet can provide a confidential and convenient medium for sexual health promotion for young people.
Objective
This paper describes the development of an interactive, theory-based website (Sexunzipped) aimed at increasing safe sexual behavior of young people, as well as an outline of the evaluation protocol.
Methods
The website focuses on safer sex, relationships, and sexual pleasure. An overview of the site is provided, including a description of the theoretical constructs which form the basis of the site development. An integrated behavioral model was chosen as the guiding theory for the Sexunzipped intervention. A randomized trial design will be used to evaluate the site quantitatively.
Results
The content of the site is described in detail with examples of the main content types: information pages, quizzes, and decision-making activities. We describe the protocol for quantitative evaluation of the website using a randomized trial design and discuss the principal challenges involved in developing the site, including the challenge of balancing the requirements of theory with young people’s views on website content and design.
Conclusions
Considerations for future interventions are discussed. Developing an online behavior-change intervention is costly and time consuming. Given the large public health potential, the cost involved in developing online interventions, and the need for attractive design, future interventions may benefit from collaborating with established sites that already have a user base, a brand, and a strong Internet presence. It is vital to involve users in decisions about intervention content, design, and features, paying attention to aspects that will attract and retain users’ interest. A central challenge in developing effective Internet-based interventions for young people is to find effective ways to operationalize theory in ways that address the views and perspectives of young people.
doi:10.2196/resprot.2114
PMCID: PMC3626157  PMID: 23612122
Internet; sex education; adolescents; young adults; health behavior; psychological theory
13.  What Young People Want From a Sexual Health Website: Design and Development of Sexunzipped 
Background
Sexual health education in the United Kingdom is of variable quality, typically focusing on the biological aspects of sex rather than on communication, relationships, and sexual pleasure. The Internet offers a unique opportunity to provide sexual health education to young people, since they can be difficult to engage but frequently use the Internet as a health information resource.
Objectives
To explore through qualitative research young people’s views on what elements of a sexual health website would be appealing and engaging, and their views on the content, design, and interactive features of the Sexunzipped intervention website.
Methods
We recruited 67 young people aged 16–22 years in London, UK. We held 21 focus groups and 6 one-to-one interviews to establish sexual health priorities, views on website look and feel, and what features of a sexual heath website would attract and engage them. Two researchers facilitated the focus groups, using a semistructured topic guide to lead the discussions and asking open questions to elicit a range of views. The discussions and interviews were audio recorded and detailed notes were made on key topics from the audio recording. Young people’s views influenced design templates for the content and interactive features of Sexunzipped.
Results
Young people particularly wanted straightforward information on sexual pleasure, sexually transmitted infections and pregnancy, how to communicate with partners, how to develop skills in giving pleasure, and emotions involved in sex and relationships. Focus group participants wanted social interaction with other young people online and wanted to see themselves reflected in some way such as through images or videos.
Conclusions
While it is challenging to meet all of young people’s technological and design requirements, consultation with the target audience is valuable and necessary in developing an online sexual health intervention. Young people are willing to talk about sensitive issues, enjoy the discussions, and can offer key insights that influence intervention development.
doi:10.2196/jmir.2116
PMCID: PMC3510764  PMID: 23060424
Sex education; adolescents; young adults; qualitative research
14.  Spatial Bias and Right Hemisphere Function: Sex-Specific Changes with Aging 
Patterns of cerebral asymmetry related to visuospatial functions may change with age. The typical leftward bias on a line bisection task may reflect cerebral asymmetry. With age, such leftward bias decreases. This study demonstrated that the age-related decrease of leftward bias may actually be sex-specific. In addition, previous research suggests that young adults’ deviation in line bisection may reflect asymmetric hemispheric activation of perceptual–attentional “where” spatial systems, rather than motor-intentional “aiming” spatial systems; thus, we specifically fractionated “where” and “aiming” bias of men and women ranging in age from 22 to 93 years old. We observed that older men produced greater rightward line bisection errors, of primarily “where” spatial character. However, women’s errors remained leftward biased, and did not significantly change with age. “Where” spatial systems may be linked to cortico-cortical processing networks involving the posterior part of the dorsal visuospatial processing stream. Thus, the current results are consistent with the conclusion that reduced right dorsal spatial activity in aging may occur in the male, but not female, adult spatial system development.
doi:10.1017/S135561771100004X
PMCID: PMC3196747  PMID: 21320378
Attention; Perception; Adult development; Hemispheric asymmetry; Pseudoneglect; Brain lateralization; Right hemisphere; Aging; Gender differences
15.  A comparison of two treatments for childhood apraxia of speech: methods and treatment protocol for a parallel group randomised control trial 
BMC Pediatrics  2012;12:112.
Background
Childhood Apraxia of Speech is an impairment of speech motor planning that manifests as difficulty producing the sounds (articulation) and melody (prosody) of speech. These difficulties may persist through life and are detrimental to academic, social, and vocational development. A number of published single subject and case series studies of speech treatments are available. There are currently no randomised control trials or other well designed group trials available to guide clinical practice.
Methods/Design
A parallel group, fixed size randomised control trial will be conducted in Sydney, Australia to determine the efficacy of two treatments for Childhood Apraxia of Speech: 1) Rapid Syllable Transition Treatment and the 2) Nuffield Dyspraxia Programme – Third edition. Eligible children will be English speaking, aged 4–12 years with a diagnosis of suspected CAS, normal or adjusted hearing and vision, and no comprehension difficulties or other developmental diagnoses. At least 20 children will be randomised to receive one of the two treatments in parallel. Treatments will be delivered by trained and supervised speech pathology clinicians using operationalised manuals. Treatment will be administered in 1-hour sessions, 4 times per week for 3 weeks. The primary outcomes are speech sound and prosodic accuracy on a customised 292 item probe and the Diagnostic Evaluation of Articulation and Phonology inconsistency subtest administered prior to treatment and 1 week, 1 month and 4 months post-treatment. All post assessments will be completed by blinded assessors. Our hypotheses are: 1) treatment effects at 1 week post will be similar for both treatments, 2) maintenance of treatment effects at 1 and 4 months post will be greater for Rapid Syllable Transition Treatment than Nuffield Dyspraxia Programme treatment, and 3) generalisation of treatment effects to untrained related speech behaviours will be greater for Rapid Syllable Transition Treatment than Nuffield Dyspraxia Programme treatment. This protocol was approved by the Human Research Ethics Committee, University of Sydney (#12924).
Discussion
This will be the first randomised control trial to test treatment for CAS. It will be valuable for clinical decision-making and providing evidence-based services for children with CAS.
Trial Registration
Australian New Zealand Clinical Trials Registry: ACTRN12612000744853
doi:10.1186/1471-2431-12-112
PMCID: PMC3441276  PMID: 22863021
Childhood apraxia of speech; Treatment; Effectiveness; Randomised control trial; Intervention; Rapid syllable transition treatment; Nuffield dyspraxia programme
16.  An economic evaluation of adaptive e-learning devices to promote weight loss via dietary change for people with obesity 
Background
The prevalence of obesity is over 25 % in many developed countries. Obesity is strongly associated with an increased risk of fatal and chronic conditions such as cardiovascular disease and type 2 diabetes. Therefore it has become a major public health concern for many economies. E-learning devices are a relatively novel approach to promoting dietary change. The new generation of devices are ‘adaptive’ and use interactive electronic media to facilitate teaching and learning. E-Learning has grown out of recent developments in information and communication technology, such as the Internet, interactive computer programmes, interactive television and mobile phones. The aim of this study is to assess the cost-effectiveness of e-learning devices as a method of promoting weight loss via dietary change.
Methods
An economic evaluation was performed using decision modelling techniques. Outcomes were expressed in terms of Quality-Adjusted Life-Years (QALYs) and costs were estimated from a health services perspective. All parameter estimates were derived from the literature. A systematic review was undertaken to derive the estimate of relative treatment effect.
Results
The base case results from the e-Learning Economic Evaluation Model (e-LEEM) suggested that the incremental cost-effectiveness ratio was approximately £102,000 per Quality-Adjusted Life-Year (QALY) compared to conventional care. This finding was robust to most alternative assumptions, except a much lower fixed cost of providing e-learning devices. Expected value of perfect information (EVPI) analysis showed that while the individual level EVPI was arguably negligible, the population level value was between £37 M and £170 M at a willingness to pay between £20,000 to £30,000 per additional QALY.
Conclusion
The current economic evidence base suggests that e-learning devices for managing the weight of obese individuals are unlikely to be cost-effective unless their fixed costs are much lower than estimated or future devices prove to be much more effective.
doi:10.1186/1472-6963-12-190
PMCID: PMC3438094  PMID: 22769737
Economic evaluation; e-learning; cost-utility analysis; obesity and weight management.
17.  Timing of radiotherapy and outcome in patients receiving adjuvant endocrine therapy 
Purpose
To evaluate the association between time from breast-conserving surgery (BCS) to radiotherapy and clinical outcome among patients treated with adjuvant endocrine therapy.
Methods
Patient information was obtained from three International Breast Cancer Study Group trials. Analysis was restricted to 964 patients treated with BCS and adjuvant endocrine therapy. Patients were divided into two groups based on the median number of days between BCS and radiotherapy and into 4 groups based on the quartile of time between BCS and radiotherapy. Endpoints were time to local recurrence (TLR), disease-free survival (DFS) and overall survival (OS). Proportional hazards regression analysis was used to perform comparisons after adjustment for baseline factors.
Results
The median time between BCS and radiotherapy was 77 days. Radiotherapy timing was significantly associated with age, menopausal status, and estrogen receptor status. After adjustment for these factors no significant effect of radiotherapy delay of up to 20 weeks was found. Adjusted hazard ratios (HRs) (radiotherapy within 77 days vs. after 77 days) were 0.94 (95% CI 0.47–1.87) for TLR, 1.05 (95% CI 0.82–1.34) for DFS and 1.07 (95% CI 0.77–1.49) for OS. For TLR the adjusted HRs for ≤48 days, 49–77 days, and 78–112 days were 0.90 (CI 95% 0.34–2.37), 0.89 (95% CI, 0.33–2.25), and 0.89 (95% CI, 0.33–2.41), respectively relative to ≥ 113 days.
Conclusions
Radiotherapy delay of up to 20 weeks was significantly associated with baseline factors such as age, menopausal status, and estrogen-receptor status. After adjustment for these factors, timing of radiotherapy was not significantly associated with TLR, DFS, or OS.
doi:10.1016/j.ijrobp.2010.02.042
PMCID: PMC2992081  PMID: 20729007
breast cancer; radiotherapy; radiotherapy timing; breast-conserving surgery; endocrine therapy
18.  From theory to 'measurement' in complex interventions: Methodological lessons from the development of an e-health normalisation instrument 
Background
Although empirical and theoretical understanding of processes of implementation in health care is advancing, translation of theory into structured measures that capture the complex interplay between interventions, individuals and context remain limited. This paper aimed to (1) describe the process and outcome of a project to develop a theory-based instrument for measuring implementation processes relating to e-health interventions; and (2) identify key issues and methodological challenges for advancing work in this field.
Methods
A 30-item instrument (Technology Adoption Readiness Scale (TARS)) for measuring normalisation processes in the context of e-health service interventions was developed on the basis on Normalization Process Theory (NPT). NPT focuses on how new practices become routinely embedded within social contexts. The instrument was pre-tested in two health care settings in which e-health (electronic facilitation of healthcare decision-making and practice) was used by health care professionals.
Results
The developed instrument was pre-tested in two professional samples (N = 46; N = 231). Ratings of items representing normalisation ‘processes’ were significantly related to staff members’ perceptions of whether or not e-health had become ‘routine’. Key methodological challenges are discussed in relation to: translating multi-component theoretical constructs into simple questions; developing and choosing appropriate outcome measures; conducting multiple-stakeholder assessments; instrument and question framing; and more general issues for instrument development in practice contexts.
Conclusions
To develop theory-derived measures of implementation process for progressing research in this field, four key recommendations are made relating to (1) greater attention to underlying theoretical assumptions and extent of translation work required; (2) the need for appropriate but flexible approaches to outcomes measurement; (3) representation of multiple perspectives and collaborative nature of work; and (4) emphasis on generic measurement approaches that can be flexibly tailored to particular contexts of study.
doi:10.1186/1471-2288-12-69
PMCID: PMC3473304  PMID: 22594537
19.  The e-health implementation toolkit: qualitative evaluation across four European countries 
Background
Implementation researchers have attempted to overcome the research-practice gap in e-health by developing tools that summarize and synthesize research evidence of factors that impede or facilitate implementation of innovation in healthcare settings. The e-Health Implementation Toolkit (e-HIT) is an example of such a tool that was designed within the context of the United Kingdom National Health Service to promote implementation of e-health services. Its utility in international settings is unknown.
Methods
We conducted a qualitative evaluation of the e-HIT in use across four countries--Finland, Norway, Scotland, and Sweden. Data were generated using a combination of interview approaches (n = 22) to document e-HIT users' experiences of the tool to guide decision making about the selection of e-health pilot services and to monitor their progress over time.
Results
e-HIT users evaluated the tool positively in terms of its scope to organize and enhance their critical thinking about their implementation work and, importantly, to facilitate discussion between those involved in that work. It was easy to use in either its paper- or web-based format, and its visual elements were positively received. There were some minor criticisms of the e-HIT with some suggestions for content changes and comments about its design as a generic tool (rather than specific to sites and e-health services). However, overall, e-HIT users considered it to be a highly workable tool that they found useful, which they would use again, and which they would recommend to other e-health implementers.
Conclusion
The use of the e-HIT is feasible and acceptable in a range of international contexts by a range of professionals for a range of different e-health systems.
doi:10.1186/1748-5908-6-122
PMCID: PMC3283514  PMID: 22098945
20.  Impact of Length or Relevance of Questionnaires on Attrition in Online Trials: Randomized Controlled Trial 
Background
There has been limited study of factors influencing response rates and attrition in online research. Online experiments were nested within the pilot (study 1, n = 3780) and main trial (study 2, n = 2667) phases of an evaluation of a Web-based intervention for hazardous drinkers: the Down Your Drink randomized controlled trial (DYD-RCT).
Objectives
The objective was to determine whether differences in the length and relevance of questionnaires can impact upon loss to follow-up in online trials.
Methods
A randomized controlled trial design was used. All participants who consented to enter DYD-RCT and completed the primary outcome questionnaires were randomized to complete one of four secondary outcome questionnaires at baseline and at follow-up. These questionnaires varied in length (additional 23 or 34 versus 10 items) and relevance (alcohol problems versus mental health). The outcome measure was the proportion of participants who completed follow-up at each of two follow-up intervals: study 1 after 1 and 3 months and study 2 after 3 and 12 months.
Results
At all four follow-up intervals there were no significant effects of additional questionnaire length on follow-up. Randomization to the less relevant questionnaire resulted in significantly lower rates of follow-up in two of the four assessments made (absolute difference of 4%, 95% confidence interval [CI] 0%-8%, in both study 1 after 1 month and in study 2 after 12 months). A post hoc pooled analysis across all four follow-up intervals found this effect of marginal statistical significance (unadjusted difference, 3%, range 1%-5%, P = .01; difference adjusted for prespecified covariates, 3%, range 0%-5%, P = .05).
Conclusions
Apparently minor differences in study design decisions may have a measurable impact on attrition in trials. Further investigation is warranted of the impact of the relevance of outcome measures on follow-up rates and, more broadly, of the consequences of what we ask participants to do when we invite them to take part in research studies.
Trial registration
ISRCTN Register 31070347; http://www.controlled-trials.com/ISRCTN31070347/31070347 Archived by WebCite at (http://www.webcitation.org/62cpeyYaY)
doi:10.2196/jmir.1733
PMCID: PMC3236666  PMID: 22100793
Attrition; retention; missing data; response rates; alcohol; online
21.  Evaluating complex interventions and health technologies using normalization process theory: development of a simplified approach and web-enabled toolkit 
Background
Normalization Process Theory (NPT) can be used to explain implementation processes in health care relating to new technologies and complex interventions. This paper describes the processes by which we developed a simplified version of NPT for use by clinicians, managers, and policy makers, and which could be embedded in a web-enabled toolkit and on-line users manual.
Methods
Between 2006 and 2010 we undertook four tasks. (i) We presented NPT to potential and actual users in multiple workshops, seminars, and presentations. (ii) Using what we discovered from these meetings, we decided to create a simplified set of statements and explanations expressing core constructs of the theory (iii) We circulated these statements to a criterion sample of 60 researchers, clinicians and others, using SurveyMonkey to collect qualitative textual data about their criticisms of the statements. (iv) We then reconstructed the statements and explanations to meet users' criticisms, embedded them in a web-enabled toolkit, and beta tested this 'in the wild'.
Results
On-line data collection was effective: over a four week period 50/60 participants responded using SurveyMonkey (40/60) or direct phone and email contact (10/60). An additional nine responses were received from people who had been sent the SurveyMonkey form by other respondents. Beta testing of the web enabled toolkit produced 13 responses, from 327 visits to http://www.normalizationprocess.org. Qualitative analysis of both sets of responses showed a high level of support for the statements but also showed that some statements poorly expressed their underlying constructs or overlapped with others. These were rewritten to take account of users' criticisms and then embedded in a web-enabled toolkit. As a result we were able translate the core constructs into a simplified set of statements that could be utilized by non-experts.
Conclusion
Normalization Process Theory has been developed through transparent procedures at each stage of its life. The theory has been shown to be sufficiently robust to merit formal testing. This project has provided a user friendly version of NPT that can be embedded in a web-enabled toolkit and used as a heuristic device to think through implementation and integration problems.
doi:10.1186/1472-6963-11-245
PMCID: PMC3205031  PMID: 21961827
22.  On-line Randomized Controlled Trial of an Internet Based Psychologically Enhanced Intervention for People with Hazardous Alcohol Consumption 
PLoS ONE  2011;6(3):e14740.
Background
Interventions delivered via the Internet have the potential to address the problem of hazardous alcohol consumption at minimal incremental cost, with potentially major public health implications. It was hypothesised that providing access to a psychologically enhanced website would result in greater reductions in drinking and related problems than giving access to a typical alcohol website simply providing information on potential harms of alcohol. DYD-RCT Trial registration: ISRCTN 31070347.
Methodology/Principal Findings
A two-arm randomised controlled trial was conducted entirely on-line through the Down Your Drink (DYD) website. A total of 7935 individuals who screened positive for hazardous alcohol consumption were recruited and randomized. At entry to the trial, the geometric mean reported past week alcohol consumption was 46.0 (SD 31.2) units. Consumption levels reduced substantially in both groups at the principal 3 month assessment point to an average of 26.0 (SD 22.3) units. Similar changes were reported at 1 month and 12 months. There were no significant differences between the groups for either alcohol consumption at 3 months (intervention: control ratio of geometric means 1.03, 95% CI 0.97 to 1.10) or for this outcome and the main secondary outcomes at any of the assessments. The results were not materially changed following imputation of missing values, nor was there any evidence that the impact of the intervention varied with baseline measures or level of exposure to the intervention.
Conclusions/Significance
Findings did not provide support for the hypothesis that access to a psychologically enhanced website confers additional benefit over standard practice and indicate the need for further research to optimise the effectiveness of Internet-based behavioural interventions. The trial demonstrates a widespread and potentially sustainable demand for Internet based interventions for people with hazardous alcohol consumption, which could be delivered internationally.
Trial Registration
Controlled-Trials.com ISRCTN31070347
doi:10.1371/journal.pone.0014740
PMCID: PMC3052303  PMID: 21408060
23.  Impact and Costs of Incentives to Reduce Attrition in Online Trials: Two Randomized Controlled Trials 
Background
Attrition from follow-up is a major methodological challenge in randomized trials. Incentives are known to improve response rates in cross-sectional postal and online surveys, yet few studies have investigated whether they can reduce attrition from follow-up in online trials, which are particularly vulnerable to low follow-up rates.
Objectives
Our objective was to determine the impact of incentives on follow-up rates in an online trial.
Methods
Two randomized controlled trials were embedded in a large online trial of a Web-based intervention to reduce alcohol consumption (the Down Your Drink randomized controlled trial, DYD-RCT). Participants were those in the DYD pilot trial eligible for 3-month follow-up (study 1) and those eligible for 12-month follow-up in the DYD main trial (study 2). Participants in both studies were randomly allocated to receive an offer of an incentive or to receive no offer of an incentive. In study 1, participants in the incentive arm were randomly offered a £5 Amazon.co.uk gift voucher, a £5 charity donation to Cancer Research UK, or entry in a prize draw for £250. In study 2, participants in the incentive arm were offered a £10 Amazon.co.uk gift voucher. The primary outcome was the proportion of participants who completed follow-up questionnaires in the incentive arm(s) compared with the no incentive arm.
Results
In study 1 (n = 1226), there was no significant difference in response rates between those participants offered an incentive (175/615, 29%) and those with no offer (162/611, 27%) (difference = 2%, 95% confidence interval [CI] –3% to 7%). There was no significant difference in response rates among the three different incentives offered. In study 2 (n = 2591), response rates were 9% higher in the group offered an incentive (476/1296, 37%) than in the group not offered an incentive (364/1295, 28%) (difference = 9%, 95% CI 5% to 12%, P < .001). The incremental cost per extra successful follow-up in the incentive arm was £110 in study 1 and £52 in study 2.
Conclusion
Whereas an offer of a £10 Amazon.co.uk gift voucher can increase follow-up rates in online trials, an offer of a lower incentive may not. The marginal costs involved require careful consideration.
Trial registration
ISRCTN31070347; http://www.controlled-trials.com/ISRCTN31070347 (Archived by WebCite at http://www.webcitation.org/5wgr5pl3s)
doi:10.2196/jmir.1523
PMCID: PMC3221348  PMID: 21371988
Nonresponse; attrition; Internet; alcohol drinking; randomized controlled trial
24.  ‘A heartbeat moment’: qualitative study of GP views of patients bringing health information from the internet to a consultation 
Background
Government policy is to encourage self-help among patients. The internet is increasingly being used for health information. The literature on the role of the internet in the doctor–patient consultation remains sparse.
Aim
To determine the perceived responses of GPs to internet-informed patients in consultations and the strategies GPs use for dealing with information from the internet being brought into consultations.
Design of study
A qualitative study design was used, with semi-structured interviews.
Setting
GPs based in North Central London.
Method
Analysis was conducted by a multidisciplinary team of researchers. Participants were 11 GPs: five partners, three locums, and three salaried doctors; seven were white, three were Asian, and one was of Chinese origin. The median year of General Medical Council (GMC) registration was 1989. There were six women and five men; five participants worked in training practices.
Results
GPs experienced considerable anxiety in response to patients bringing information from the internet to a consultation but were able to resolve this anxiety. The study participants learned to distance themselves from their emotional response, and used cognitive and behavioural techniques to assist them in responding appropriately to patients. These techniques included buying time in a consultation, learning from previous consultations, and using the internet as an ally, by directing patients to particular websites. The importance for doctors of feeling valued by patients was apparent, as was the effect of the prior doctor–patient relationship.
Conclusion
GPs interviewed used sophisticated mechanisms for dealing with their emotions. GPs struggling with internet-informed patients can use the mechanisms described to alleviate the difficulties.
doi:10.3399/bjgp10X483120
PMCID: PMC2814261  PMID: 20132702
general practice; internet; physician–patient relations
25.  Why is it difficult to implement e-health initiatives? A qualitative study 
Background
The use of information and communication technologies in healthcare is seen as essential for high quality and cost-effective healthcare. However, implementation of e-health initiatives has often been problematic, with many failing to demonstrate predicted benefits. This study aimed to explore and understand the experiences of implementers -- the senior managers and other staff charged with implementing e-health initiatives and their assessment of factors which promote or inhibit the successful implementation, embedding, and integration of e-health initiatives.
Methods
We used a case study methodology, using semi-structured interviews with implementers for data collection. Case studies were selected to provide a range of healthcare contexts (primary, secondary, community care), e-health initiatives, and degrees of normalization. The initiatives studied were Picture Archiving and Communication System (PACS) in secondary care, a Community Nurse Information System (CNIS) in community care, and Choose and Book (C&B) across the primary-secondary care interface. Implementers were selected to provide a range of seniority, including chief executive officers, middle managers, and staff with 'on the ground' experience. Interview data were analyzed using a framework derived from Normalization Process Theory (NPT).
Results
Twenty-three interviews were completed across the three case studies. There were wide differences in experiences of implementation and embedding across these case studies; these differences were well explained by collective action components of NPT. New technology was most likely to 'normalize' where implementers perceived that it had a positive impact on interactions between professionals and patients and between different professional groups, and fit well with the organisational goals and skill sets of existing staff. However, where implementers perceived problems in one or more of these areas, they also perceived a lower level of normalization.
Conclusions
Implementers had rich understandings of barriers and facilitators to successful implementation of e-health initiatives, and their views should continue to be sought in future research. NPT can be used to explain observed variations in implementation processes, and may be useful in drawing planners' attention to potential problems with a view to addressing them during implementation planning.
doi:10.1186/1748-5908-6-6
PMCID: PMC3038974  PMID: 21244714

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