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1.  Health on the Web: Randomised Controlled Trial of Online Screening and Brief Alcohol Intervention Delivered in a Workplace Setting 
PLoS ONE  2014;9(11):e112553.
Background
Alcohol misuse in England costs around £7.3 billion (US$12.2 billion) annually from lost productivity and absenteeism. Delivering brief alcohol interventions to employees as part of a health check may be acceptable, particularly with online delivery which can provide privacy for this stigmatised behaviour. Research to support this approach is limited and methodologically weak. The aim was to determine the effectiveness of online screening and personalised feedback on alcohol consumption, delivered in a workplace as part of a health check.
Methods and Findings
This two-group online individually randomised controlled trial recruited employees from a UK-based private sector organisation (approx. 100,000 employees). 3,375 employees completed the online health check in the three week recruitment period. Of these, 1,330 (39%) scored five or more on the AUDIT-C (indicating alcohol misuse) and were randomised to receive personalised feedback on their alcohol intake, alongside feedback on other health behaviours (n = 659), or to receive feedback on all health behaviours except alcohol intake (n = 671). Participants were mostly male (75%), with a median age of 48 years and half were in managerial positions (55%). Median Body Mass Index was 26, 12% were smokers, median time undertaking moderate/vigorous physical activity a week was 173 minutes and median fruit and vegetable consumption was three portions a day. Eighty percent (n = 1,066) of participants completed follow-up questionnaires at three months. An intention to treat analysis found no difference between experimental groups for past week drinking (primary outcome) (5.6% increase associated with the intervention (95% CI −4.7% to 16.9%; p = .30)), AUDIT (measure of alcohol-related harm) and health utility (EQ-5D).
Conclusions
There was no evidence to support the use of personalised feedback within an online health check for reducing alcohol consumption among employees in this organisation. Further research is needed on how to engage a larger proportion of employees in screening.
Trial Registration
International Standard Randomised Controlled Trial Number Register ISRCTN50658915
doi:10.1371/journal.pone.0112553
PMCID: PMC4237335  PMID: 25409454
2.  Experiences of using email for general practice consultations: a qualitative study 
The British Journal of General Practice  2013;63(616):e760-e767.
Background
Reports suggest approximately 21–23% of GPs in the UK have consulted with patients using email, but little is known about the nature of this use and what it means for clinicians and patients in general practice.
Aim
To understand the use of email consultation in general practice by investigating the experiences of existing users and views of experts.
Design and setting
A qualitative study conducted in 2010 using purposive sampling and semi-structured interviews in general practice and community settings in some London boroughs.
Method
A maximum variation sample of GPs and patients who had used email for consultation in general practice were recruited, as were policy and/or implementation experts. Interviews continued until saturation was achieved.
Results
In total 10 GPs, 14 patients, and six experts were interviewed. Consultation by email was often triggered by logistic or practical issues; motivators for ongoing use were the benefits, such as convenience, for GPs and patients. Both GPs and patients reported concerns about safety and lack of guidance about the ‘rules of engagement’ in email consultations, with GPs also concerned about workload. In response, both groups attempted to introduce their own rules, although this only went some way to addressing uncertainty. Long term, participants felt there was a need for regulation and guidance.
Conclusion
Consultations by email in general practice occur in an unregulated and unstructured way. Current UK policy is to promote consultations by email, making it crucial to consider the responsibility and workload faced by clinicians, and the changes required to ensure safe use; not doing so may risk safety breaches and result in suboptimal care for patients.
doi:10.3399/bjgp13X674440
PMCID: PMC3809429  PMID: 24267859
electronic mail; family practice; physician–patient relations; qualitative evaluation
3.  Self-management support interventions to reduce health care utilisation without compromising outcomes: a systematic review and meta-analysis 
Background
There is increasing interest in the role of ‘self-management’ interventions to support the management of long-term conditions in health service settings. Self-management may include patient education, support for decision-making, self-monitoring and psychological and social support. Self-management support has potential to improve the efficiency of health services by reducing other forms of utilisation (such as primary care or hospital use), but a shift to self-management may lead to negative outcomes, such as patients who feel more anxious about their health, are less able to cope, or who receive worse quality of care, all of which may impact on their health and quality of life. We sought to determine which models of self-management support are associated with significant reductions in health services utilisation without compromising outcomes among patients with long-term conditions.
Methods
We used systematic review with meta-analysis. We included randomised controlled trials in patients with long-term conditions which included self-management support interventions and reported measures of service utilisation or costs, as well as measures of health outcomes (standardized disease specific quality of life, generic quality of life, or depression/anxiety).We searched multiple databases (CENTRAL, CINAHL, Econlit, EMBASE, HEED, MEDLINE, NHS EED and PsycINFO) and the reference lists of published reviews. We calculated effects sizes for both outcomes and costs, and presented the results in permutation plots, as well as conventional meta-analyses.
Results
We included 184 studies. Self-management support was associated with small but significant improvements in health outcomes, with the best evidence of effectiveness in patients with diabetic, respiratory, cardiovascular and mental health conditions. Only a minority of self-management support interventions reported reductions in health care utilisation in association with decrements in health. Evidence for reductions in utilisation associated with self-management support was strongest in respiratory and cardiovascular problems. Studies at higher risk of bias were more likely to report benefits.
Conclusions
Self-management support interventions can reduce health service utilization without compromising patient health outcomes, although effects were generally small, and the evidence was strongest in respiratory and cardiovascular disorders. Further work is needed to determine which components of self-management support are most effective.
Electronic supplementary material
The online version of this article (doi:10.1186/1472-6963-14-356) contains supplementary material, which is available to authorized users.
doi:10.1186/1472-6963-14-356
PMCID: PMC4177163  PMID: 25164529
Self-management support interventions; Long-term conditions; Health outcomes; Quality of life; Health care utilization; Hospitalizations; Costs; Cost-effectiveness; Systematic review; Meta-analysis
4.  Addressing the evidence to practice gap for complex interventions in primary care: a systematic review of reviews protocol 
BMJ Open  2014;4(6):e005548.
Introduction
Getting the results of research implemented into routine healthcare is often a challenge. The disconnect between the development and implementation of evidence into practice is called the ‘second translational gap’ and is particularly apparent in primary care. To address this gap, we plan to identify, summarise and synthesise currently available evidence by undertaking a systematic review of reviews to: (1) explore barriers and facilitators of implementation of research evidence or complex interventions, and (2) assess the effectiveness of strategies in facilitating implementation of complex interventions in primary care.
Methods and analysis
This is a protocol for a systematic review of reviews. We will search MEDLINE, EMBASE, the Cochrane Library, CINAHL and PsycINFO up until December 2013. We will check reference lists of included studies for further studies. Two authors will independently screen the titles and abstracts identified from the search; any discrepancies will be resolved by discussion and consensus. Full-text papers will be obtained and relevant reviews will be selected against inclusion criteria. Eligible reviews have to be based on predominantly primary care in developed countries and examine either factors to implementation or, the effectiveness of strategies to optimise implementation. Data from eligible reviews will be extracted using standardised data abstraction forms. For barriers and facilitators, data will be synthesised using an interpretative meta-synthesis approach. For implementation strategies, findings will be summarised and described narratively and synthesised using a framework approach. All findings will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.
Ethics and dissemination
Ethical approval is not required. The review findings will inform the work of the design and implementation of future studies and will be of interest to a wide audience including health professionals, researchers, health service or commissioning managers and policymakers.
Trial registration number
Protocol registration number (PROSPERO CRD42014009410).
doi:10.1136/bmjopen-2014-005548
PMCID: PMC4067819  PMID: 24958212
Primary Care; Public Health
5.  Perceptual versus conceptual interference and pattern separation of verbal stimuli in young and older adults 
Hippocampus  2013;23(6):425-430.
Recently, several studies have strongly suggested that age-related decline in episodic memory is associated with deficits in hippocampal pattern separation (orthogonalizing overlapping experiences using distinct neural codes). The same studies also link these deficits to neurobiological features such as dentate/CA3 representational rigidity and perforant path loss. This decline in pattern separation is thought to underlie behavioral deficits in discriminating similar stimuli on pictorial tasks. Similar pictorial stimuli invoke interference both in the perceptual and conceptual domains, and do not allow one to be disentangled from another. For example, it is very difficult to design a set of pictorial stimuli that are perceptually similar yet conceptually unrelated. Verbal stimuli, on the other hand, allow experimenters to independently manipulate conceptual and perceptual interference. We tested discrimination on conceptually similar (semantically related) and perceptually similar (phonologically related) verbal stimuli in young (mean age 20) and older adults (mean age 69), and find that older adults are selectively impaired in perceptual pattern separation. This deficit was not secondary to failure in working memory, attention, or visual processing. Based on past studies, we suggest that perceptual discrimination relies on recollection while conceptual discrimination relies more on gist. Our results fit well within the notion that recollection but not familiarity (i.e. gist) is impaired in older adults, and suggests that the impairment observed in pictorial tasks may be driven mostly by failure in perceptual and not conceptual pattern separation.
doi:10.1002/hipo.22110
PMCID: PMC3968906  PMID: 23505005
hippocampus; pattern separation; perceptual interference; conceptual interference; phonological; semantic
6.  Ancient host shifts followed by host conservatism in a group of ant parasitoids 
While ant colonies serve as host to a diverse array of myrmecophiles, few parasitoids are able to exploit this vast resource. A notable exception is the wasp family Eucharitidae, which is the only family of insects known to exclusively parasitize ants. Worldwide, approximately 700 Eucharitidae species attack five subfamilies across the ant phylogeny. Our goal is to uncover the pattern of eucharitid diversification, including timing of key evolutionary events, biogeographic patterns and potential cophylogeny with ant hosts. We present the most comprehensive molecular phylogeny of Eucharitidae to date, including 44 of the 53 genera and fossil-calibrated estimates of divergence dates. Eucharitidae arose approximately 50 Ma after their hosts, during the time when the major ant lineages were already established and diversifying. We incorporate host association data to test for congruence between eucharitid and ant phylogenies and find that their evolutionary histories are more similar than expected at random. After a series of initial host shifts, clades within Eucharitidae maintained their host affinity. Even after multiple dispersal events to the New World and extensive speciation within biogeographic regions, eucharitids remain parasitic on the same ant subfamilies as their Old World relatives, suggesting host conservatism despite access to a diverse novel ant fauna.
doi:10.1098/rspb.2013.0495
PMCID: PMC3619522  PMID: 23554396
Eucharitidae; molecular dating; cophylogenetic reconstruction; diversification
7.  Initial Outcomes From a 4-Week Follow-Up Study of the Text4baby Program in the Military Women’s Population: Randomized Controlled Trial 
Background
The use of mobile phone technologies for health promotion and disease prevention has advanced rapidly in recent years. Text4baby is a theory-based mobile health (mHealth) program in which text messages are delivered to pregnant women and new mothers to improve their health care beliefs and behaviors and improve health status and clinical outcomes. Recent evaluations of Text4baby have found that it improves targeted health attitudes and beliefs, but effects on behavior have not yet been determined.
Objective
In this study, investigators aimed to evaluate Text4baby in the military women’s population.
Methods
Investigators conducted a randomized controlled trial at Madigan Army Medical Center in Tacoma, Washington, from December 2011 through September 2013. All participants were pregnant women first presenting for care at Madigan. Investigators conducted a baseline assessment using a 24-item, self-administered online survey of attitudes and behaviors related to Text4baby message content. Participants were randomized to Text4baby plus usual care (intervention) or usual care alone (control). Investigators analyzed treatment effects of Text4baby on short-term targeted outcomes 4 weeks post enrollment.
Results
For this study, 943 patients were randomized and completed a baseline assessment. The average patient age was 28 years and nearly 70% self-identified as Caucasian. 48.7% of enrollees (459/943) completed the first follow-up assessment. Higher rates of single and working/in-school patients dropped out of the intervention arm of the study, and we adjusted for this finding in subsequent models. However, while investigators were unable to re-survey these participants, only 1.9% of Text4baby enrollees (18/943) dropped the service during the study period. Adjusted and unadjusted logistic generalized estimating equation models were developed to assess intervention effects on measured outcomes. In the model adjusting for age, marital status, having had a previous baby, and race/ethnicity, there was a significant effect of Text4baby intervention exposure on increased agreement with belief in the importance of taking prenatal vitamins (OR 1.91, 95% CI 1.08-3.34, P=.024). All of these attitudes had been targeted by at least one text message during the 4-week evaluation period examined in this study. In unadjusted models, there was a significant effect of intervention exposure on belief in the importance of visiting a health care provider to be a healthy new mother (OR 1.52, 95% CI 1.01-2.31, P=.046) and in the health risks of alcohol during pregnancy (OR 2.06, 95% CI 1.00-4.31, P=.05). No behavioral effects of the intervention were observed in this analysis.
Conclusions
Text4baby is a promising program that offers lessons for future mHealth activities. This large-scale study demonstrated initial effects of the program on attitudes and beliefs targeted by the messages received by women during the study period. Results confirm previous findings from Text4baby studies and other mHealth research. Future analyses will examine dosage effects of the intervention on behaviors and clinical outcomes.
doi:10.2196/jmir.3297
PMCID: PMC4051747  PMID: 24846909
Text4baby; prenatal health care; mobile health; military health; health behavior
8.  Does Brief Telephone Support Improve Engagement With a Web-Based Weight Management Intervention? Randomized Controlled Trial 
Background
Recent reviews suggest Web-based interventions are promising approaches for weight management but they identify difficulties with suboptimal usage. The literature suggests that offering some degree of human support to website users may boost usage and outcomes.
Objective
We disseminated the POWeR (“Positive Online Weight Reduction”) Web-based weight management intervention in a community setting. POWeR consisted of weekly online sessions that emphasized self-monitoring, goal-setting, and cognitive/behavioral strategies. Our primary outcome was intervention usage and we investigated whether this was enhanced by the addition of brief telephone coaching. We also explored group differences in short-term self-reported weight loss.
Methods
Participants were recruited using a range of methods including targeted mailouts, advertisements in the local press, notices on organizational websites, and social media. A total of 786 adults were randomized at an individual level through an online procedure to (1) POWeR only (n=264), (2) POWeR plus coaching (n=247), or (3) a waiting list control group (n=275). Those in the POWeR plus coaching arm were contacted at approximately 7 and 28 days after randomization for short coaching telephone calls aimed at promoting continued usage of the website. Website usage was tracked automatically. Weight was assessed by online self-report.
Results
Of the 511 participants allocated to the two intervention groups, the median number of POWeR sessions completed was just one (IQR 0-2 for POWeR only, IQR 0-3 for POWeR plus coach). Nonetheless, a substantial minority completed at least the core three sessions of POWeR: 47 participants (17.8%, 47/264) in the POWeR-only arm and 64 participants (25.9%, 64/247) in the POWeR plus coaching arm. Participants in the POWeR plus coaching group persisted with the intervention for longer and were 1.61 times more likely to complete the core three sessions than the POWeR-only group (χ2 1=4.93; OR 1.61, 95% CI 1.06-2.47; n=511). An intention-to-treat analysis showed between-group differences in weight loss (F 2,782=12.421, P<.001). Both intervention groups reported more weight loss than the waiting list control group. Weight loss was slightly, but not significantly, greater in the POWeR plus coaching group. A large proportion of participants assigned to POWeR plus coaching refused phone calls or were not contactable (57.9%, 143/247). Exploratory analyses identified health and sociodemographic differences between those who did and did not engage in coaching when it was made available to them. Users who engaged with coaching used the intervention more and lost more weight than those who did not.
Conclusions
In common with most Web-based intervention studies, usage of POWeR was suboptimal overall. However, our findings suggest that supplementing Web-based weight management with brief human support could improve usage and outcomes in those who take it up.
Trial Registration
International Standard Randomized Controlled Trial Number (ISRCTN): 98176068; http://www.controlled-trials.com/ISRCTN98176068 (Archived by WebCite at http://www.webcitation.org/6OKRjM2oy).
doi:10.2196/jmir.3199
PMCID: PMC4004138  PMID: 24681761
weight loss; obesity; Internet; adherence; behavioral; randomized controlled trial
9.  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
10.  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
11.  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
12.  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
13.  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
14.  ‘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
15.  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
16.  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
17.  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
19.  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
20.  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
21.  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
22.  Web-Based Interventions for Behavior Change and Self-Management: Potential, Pitfalls, and Progress 
Medicine 2.0  2012;1(2):e3.
The potential advantages of using the Internet to deliver self-care and behavior-change programs are well recognized. An aging population combined with the increasing prevalence of long-term conditions and more effective medical interventions place financial strain on all health care systems. Web-based interventions have the potential to combine the tailored approach of face-to-face interventions with the scalability of public health interventions that have low marginal costs per additional user. From a patient perspective, Web-based interventions can be highly attractive because they are convenient, easily accessible, and can maintain anonymity/privacy. Recognition of this potential has led to research in developing and evaluating Web-based interventions for self-management of long-term conditions and behavior change. Numerous systematic reviews have confirmed the effectiveness of some Web-based interventions, but a number of unanswered questions still remain. This paper reviews the progress made in developing and evaluating Web-based interventions and considers three challenging areas: equity, effectiveness, and implementation. The impact of Web-based interventions on health inequalities remains unclear. Although some have argued that such interventions can increase access to underserved communities, there is evidence to suggest that reliance on Web-based interventions may exacerbate health inequalities by excluding those on the “wrong” side of the digital divide. Although most systematic reviews have found a positive effect on outcomes of interest, effect sizes tend to be small and not all interventions are successful. Further work is needed to determine why some interventions work and others do not. This includes considering the “active ingredients” or mechanism of action of these complex interventions and the context in which they are used. Are there certain demographic, psychological, or clinical factors that promote or inhibit success? Are some behaviors or some clinical problems more amenable to change by computer-based interventions? Equally problematic is the issue of implementation and integration of such programs into routine clinical practice. Many eHealth projects end when the research is concluded and fail to become part of mainstream clinical care. One way of addressing these challenges is to apply the Medical Research Council framework for developing, evaluating, and implementing complex interventions. This includes having a strong theoretical foundation, developing a proposed mechanism or pathway of action, ensuring that the evaluation adequately reflects this proposed pathway, and considering implementation from the beginning of the development process.
doi:10.2196/med20.1741
PMCID: PMC4084772  PMID: 25075231
Internet; self-care; eHealth; health behavior
23.  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
24.  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.
25.  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

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