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1.  Lamotrigine versus inert placebo in the treatment of borderline personality disorder: study protocol for a randomized controlled trial and economic evaluation 
Trials  2015;16:308.
Background
People with borderline personality disorder (BPD) experience rapid and distressing changes in mood, poor social functioning and have high rates of suicidal behaviour. Several small scale studies suggest that mood stabilizers may produce short-term reductions in symptoms of BPD, but have not been large enough to fully examine clinical and cost-effectiveness.
Methods/Design
A two parallel-arm, placebo controlled randomized trial of usual care plus either lamotrigine or an inert placebo for people aged over 18 who are using mental health services and meet diagnostic criteria for BPD. We will exclude people with comorbid bipolar affective disorder or psychosis, those already taking a mood stabilizer, those who speak insufficient English to complete the baseline assessment and women who are pregnant or contemplating becoming pregnant. Those meeting inclusion criteria and provide written informed consent will be randomized to up to 200mg of lamotrigine per day or an inert placebo (up to 400mg if taking combined oral contraceptives).Participants will be randomized via a remote web-based system using permuted stacked blocks stratified by study centre, severity of personality disorder, and level of bipolarity.
Follow-up assessments will be conducted by masked researchers 12, 24 weeks, and 52 weeks after randomization. The primary outcome is the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD). The secondary outcomes are depressive symptoms, deliberate self-harm, social functioning, health-related quality of life, resource use and costs, side effects of treatment, adverse events and withdrawal of trial medication due to adverse effects.
The main analyses will use intention to treat without imputation of missing data. The economic evaluation will take an NHS/Personal Social Services perspective. A cost-utility analysis will compare differences in total costs and differences in quality of life using QALYs derived from the EQ-5D.
Discussion
The evidence base for the use of pharmacological treatments for people with borderline personality disorder is poor. In this trial we will examine the clinical and cost-effectiveness of lamotrigine to assess what if any impact offering this has on peoples’ mental health, social functioning, and use of other medication and other resources.
Trial registration
Current Controlled Trials ISRCTN90916365 (registered 01/08/2012)
doi:10.1186/s13063-015-0823-x
PMCID: PMC4506596  PMID: 26187496
Borderline personality disorder; Mood stabilizer; Lamotrigine; Randomized trial
2.  To tweet or not to tweet about schizophrenia systematic reviews (TweetSz): study protocol for a randomised controlled trial 
BMJ Open  2015;5(7):e007695.
Introduction
The Cochrane Schizophrenia Group (CSzG) has produced and maintained systematic reviews of effects of interventions for schizophrenia and related illness. Each review has a Plain Language Summary (PLS), for those without specialised knowledge, and an abstract, which are freely available from The Cochrane Library (https://summaries.cochrane.org). Increasingly, evidence is being distributed using social media such as Twitter and Weibo (in China) alongside traditional publications.
Methods and analysis
In a prospective two-arm, parallel, open randomised controlled trial with a 1:1 allocation ratio, we will allocate 170 published systematic reviews into the intervention group (tweeting arm/Weibo arm) versus the control group (non-tweeting arm). Reviews will be stratified by baseline access activity, defined as high (≥19 views per week, n=14), medium (4.3 to 18.99 views per week, n=72) or low (<4.3 views per week, n=84), based on Google Analytics, which will also be used for evaluating outcomes. The intervention group will have three tweets daily using Hootsuite with a slightly different accompanying text (written by CEA and AB) and a shortened Uniform Resource Locator (URL) to the PLS: a) The review title as it appears in summaries.cochrane.org, b) A pertinent extract from results or discussion sections of the abstract and c) An intriguing question or pithy statement related to the evidence in the abstract. The primary outcome will be: total number of visits to a PLS in 7 days following the tweet. Secondary outcomes will include % new visits, bounce rate, pages per visit, visit duration, page views, unique page views, time on page, entrances, exiting behaviour and country distribution.
Ethics and dissemination
This study does not involve living participants, and uses information available in the public domain. Participants are published systematic reviews, hence, no ethical approval is required. Dissemination will be via Twitter, Weibo and traditional academic means.
Trial registration number
ISRCTN84658943.
doi:10.1136/bmjopen-2015-007695
PMCID: PMC4499712  PMID: 26159452
PSYCHIATRY
3.  A cluster randomized clinical trial of a stepped care intervention for depression in primary care (STEPCARE)- study protocol 
BMC Psychiatry  2015;15:148.
Background
Depression constitutes a significant public health burden and is associated is with high level of individual suffering. Insufficient human and material resources impede the provision of adequate care for persons with the condition in low- and middle-income countries. It is commonly recognized that, to bridge this treatment gap, it is essential to integrate the treatment of depression into primary health care system.
Methods/Design
STEPCARE is a two-arm parallel cluster randomized controlled trial to compare a stepped-care intervention package for depression in primary health care with care as usual in Nigeria. Randomization was conducted at the level of the participating primary health care clinics, while interventions are delivered to consenting individual participants who screen positive on the 9-item patient health questionnaire (PHQ-9 score ≥ 11) and fulfil the DSM-IV criteria for major depression. Intervention delivered by trained primary health care workers (PHCW) supported by general physicians and psychiatrists as needed is in 3 steps determined by response to treatment. Each step consists of psychological interventions (including psychoeducation, activity scheduling, social network reactivation and problem solving treatment) offered to all participants and, depending on severity and response, medication. Primary outcome, assessed at 12 months following recruitment into the trial, is recovery from depression as shown by a PHQ-9 score of less than 6. Secondary outcomes include changes in disability, quality of life and service utilization assessed at 6 and 12 months.
Discussion
The stepped care model examines the effectiveness of an intervention package for depression in which the intensity of treatment is determined by the clinical need of the patients. This approach is designed to make the most efficient use of available resources.
Trial registration
ISRCTN46754188 (ISRTCN registry at isrtcn.com; registered 23 September 2013)
doi:10.1186/s12888-015-0542-6
PMCID: PMC4492084  PMID: 26149444
Depression; Primary health care; Stepped care
4.  Expanding care for perinatal women with depression (EXPONATE): study protocol for a randomized controlled trial of an intervention package for perinatal depression in primary care 
BMC Psychiatry  2015;15:136.
Background
Depression is common among women during perinatal period and is associated with long-term adverse consequences for the mother and infant. In Nigeria, as in many other low- and-middle-income countries (LMIC), perinatal depression usually goes unrecognized and untreated. The aim of EXPONATE is to test the effectiveness and cost-effectiveness of an intervention package for perinatal depression delivered by community midwives in primary maternal care in which physician support and enhanced patient compliance are implemented using mobile phones.
Methods/Study design
A pragmatic two-arm parallel cluster randomized controlled trial was designed. The units of allocation are the primary maternal care clinics. Thirty eligible and consenting clinics were randomized but, due to problems with logistics, 29 eventually participated. Consenting pregnant women with a gestational age between 16 and 28 weeks who screened positive on the Edinburgh Postnatal Depression Scale (EPDS score ≥12), absent psychosis or bipolar disorder, and not actively suicidal were recruited into the trial (N = 686). Midwives in the intervention arm were trained to deliver psychoeducation, problem solving treatment, and parenting skills. Eight weekly sessions were delivered following entry into the study. Further sessions during pregnancy and 6 weeks following childbirth were determined by level of depressive symptoms. Clinical support and supervision, delivered mainly by mobile phone, were provided by general physicians and psychiatrists. Automated text and voice messages, also delivered by mobile phones, were used to facilitate patient compliance with clinic appointments and ‘homework’ tasks. Patients in the control arm received care as usual enhanced by further training of the providers in that arm in the recognition and standard treatment of depression. Assessments are undertaken at baseline, 2 months following recruitment into the study and 3, 6, 9 and 12 months after childbirth. The primary outcome is recovery from depression (EPDS < 6) at 6 months. Secondary outcomes include measures of disability, parenting skills, maternal attitudes, health care utilization as well as infant physical and cognitive development comprehensively assessed using the Bayley’s Scales.
Discussion
To the best of our knowledge, this is the largest randomized controlled trial of an intervention package delivered by community midwives in sub-Saharan Africa.
Trial registration
Trial is registered with the ISRTCN registry at isrtcn.com; Trial number ISRCTN60041127. Date of registration is 15/05/2013.
doi:10.1186/s12888-015-0537-3
PMCID: PMC4486135  PMID: 26122982
Perinatal depression; Primary care; Cluster randomized trial
5.  Who does not participate in telehealth trials and why? A cross-sectional survey 
Trials  2015;16:258.
Background
Telehealth interventions use information and communication technology to provide clinical support. Some randomised controlled trials of telehealth report high patient decline rates. A large study was undertaken to determine which patients decline to participate in telehealth trials and their reasons for doing so.
Methods
Two linked randomised controlled trials were undertaken, one for patients with depression and one for patients with raised cardiovascular disease risk (the Healthlines Study). The trials compared usual care with additional support delivered by the telephone and internet. Patients were recruited via their general practice and could return a form about why they were not participating.
Results
Of the patients invited, 82.9 % (20,021/24,152) did not accept the study invite, either by returning a decline form (n = 7134) or by not responding (n = 12,887). In both trials patients registered at deprived general practices were less likely to accept the study invite. Decline forms were received from 29.5 % (7134/24,152) of patients invited. There were four frequently reported types of reasons for declining. The most common was telehealth-related: 54.7 % (3889/,7115) of decliners said they did not have access or the skills to use the internet and/or computers. This was more prevalent amongst older patients and patients registered at deprived general practices. The second was health need-related: 40.1 % (n = 2852) of decliners reported that they did not need additional support for their health condition. The third was related to life circumstances: 27.2 % (n = 1932) of decliners reported being too busy. The fourth was research-related: 15.3 % (n = 1092) of decliners were not interested in the research.
Conclusions
A large proportion of patients declining participation in these telehealth trials did so because they were unable to engage with telehealth or did not perceive a need for it. This has implications for engagement with telehealth in routine practice, as well as for trials, with a need to offer technological support to increase patients’ engagement with telehealth. More generally, triallists should assess why people decline to participate in their studies.
Trial registration
The Healthlines Study has the following trial registrations: depression trial: ISRCTN14172341 (registered 26 June 2012) and CVD risk trial: ISRCTN27508731 (registered 05 July 2012).
doi:10.1186/s13063-015-0773-3
PMCID: PMC4464859  PMID: 26044763
Telehealth; Trials; Declines; Recruitment; Non-participation; Refusers
6.  A pilot randomized controlled trial of a stepped care intervention package for depression in primary care in Nigeria 
BMC Psychiatry  2015;15:96.
Background
Depression is common in primary care and is often unrecognized and untreated. Studies are needed to demonstrate the feasibility of implementing evidence-based depression care provided by primary health care workers (PHCWs) in sub-Saharan Africa. We carried out a pilot two-parallel arm cluster randomized controlled trial of a package of care for depression in primary care.
Methods
Six primary health care centers (PHCC) in two Local Government Areas of Oyo State, South West Nigeria were randomized into 3 intervention and 3 control clinics. Three PHCWs were selected for training from each of the participating clinics. The PHCWs from the intervention clinics were trained to deliver a manualized multicomponent stepped care intervention package for depression consisting of psychoeducation, activity scheduling, problem solving treatment and medication for severe depression. Providers from the control clinics delivered care as usual, enhanced by a refresher training on depression diagnosis and management. Outcome measures Patient’s Health Questionnaire (PHQ-9), WHO quality of Life instrument (WHOQOL-Bref) and the WHO disability assessment schedule (WHODAS) were administered in the participants’ home at baseline, 3 and 6 months.
Results
About 98% of the consecutive attendees to the clinics agreed to have the screening interview. Of those screened, 284 (22.7%) were positive (PHQ-9 score ≥ 8) and 234 gave consent for inclusion in the study: 165 from intervention and 69 from control clinics. The rates of eligible and consenting participants were similar in the control and intervention arms. In all 85.9% (92.8% in intervention and 83% in control) of the participants were successfully administered outcome assessments at 6 months. The PHCWs had little difficulty in delivering the intervention package. At 6 months follow up, depression symptoms had improved in 73.0% from the intervention arm compared to 51.6% control. Compared to the mean scores at baseline, there was improvement in the mean scores on all outcome measures in both arms at six months.
Conclusion
The results provide support for the feasibility of conducting a fully-powered randomized study in this setting and suggest that the instruments used may have the potential to detect differences between the arms.
Trial registration number
ISRCTN46754188 (ISRTCN registry at isrtcn.com); registered 23 September 2013, details of the pilot study added 12/02/2015.
doi:10.1186/s12888-015-0483-0
PMCID: PMC4424568  PMID: 25929840
Depression; Primary care; Clinical trial; Stepped care intervention
7.  Patient–doctor continuity and diagnosis of cancer: electronic medical records study in general practice 
The British Journal of General Practice  2015;65(634):e305-e311.
Background
Continuity of care may affect the diagnostic process in cancer but there is little research.
Aim
To estimate associations between patient–doctor continuity and time to diagnosis and referral of three common cancers.
Design and setting
Retrospective cohort study in general practices in England.
Method
This study used data from the General Practice Research Database for patients aged ≥40 years with a diagnosis of breast, colorectal, or lung cancer. Relevant cancer symptoms or signs were identified up to 12 months before diagnosis. Patient–doctor continuity (fraction-of-care index adjusted for number of consultations) was calculated up to 24 months before diagnosis. Time ratios (TRs) were estimated using accelerated failure time regression models.
Results
Patient–doctor continuity in the 24 months before diagnosis was associated with a slightly later diagnosis of colorectal (time ratio [TR] 1.01, 95% confidence interval [CI] =1.01 to 1.02) but not breast (TR = 1.00, 0.99 to 1.01) or lung cancer (TR = 1.00, 0.99 to 1.00). Secondary analyses suggested that for colorectal and lung cancer, continuity of doctor before the index consultation was associated with a later diagnosis but continuity after the index consultation was associated with an earlier diagnosis, with no such effects for breast cancer. For all three cancers, most of the delay to diagnosis occurred after referral.
Conclusion
Any effect for patient–doctor continuity appears to be small. Future studies should compare investigations, referrals, and diagnoses in patients with and without cancer who present with possible cancer symptoms or signs; and focus on ‘difficult to diagnose’ types of cancer.
doi:10.3399/bjgp15X684829
PMCID: PMC4408510  PMID: 25918335
cancer; continuity of care; diagnosis; general practice; patient-doctor continuity; symptoms
8.  Comparing different dosing regimens of bevacizumab in the treatment of neovascular macular degeneration: study protocol for a randomised controlled trial 
Trials  2015;16:85.
Background
Bevacizumab (Avastin®) is as effective as ranibizumab (Lucentis®) in the treatment of neovascular age-related macular degeneration (nAMD). However it has two important structural differences. First, it has two active sites instead of one; second, it retains the Fc portion of the antibody which would be expected to confer a significantly longer half-life. These agents have been associated with systemic complications including strokes, so it is desirable to use the smallest effective dose. Furthermore, the standard dosing regimen requires monthly hospital visits, which present a significant challenge both to the hospital services and to the patients (who are elderly).
Methods/Design
Patients ≥50 years who are eligible for anti-vascular endothelial growth factor (VEGF) treatment of nAMD in the NHS, who are either newly referred for treatment or have reactivation of nAMD and who have not received treatment to either eye for the previous six months.
We have designed a factorial multi-centre masked randomised controlled trial using bevacizumab as the intervention, with patients randomised to one of four arms: to standard or low dose and to monthly or two-monthly patient review. The aim is to recruit sufficient patients (around 1,000) to obtain 304 patients meeting the endpoint over a four-year period. The primary endpoint is time to treatment failure to be analysed using Cox regression.
Discussion
This randomised control trial will show if half dose and two monthly as required is as effective as full dose and monthly regimes. A two monthly as required regimen of Bevacizumab would significantly reduce both the cost and the service delivery burden for the treatment of nAMD while a reduced dose would be expected to enhance the safety profile of this treatment regime.
Trial registration
International Standard Randomised Controlled Trial Number: ISRCTN95654194, registered on 22 September 2009.
doi:10.1186/s13063-015-0608-2
PMCID: PMC4376508  PMID: 25873213
Age-related macular degeneration; Avastin®; Bevacizumab; Trial
9.  Increasing children’s physical activity through a teaching-assistant led extracurricular intervention: process evaluation of the action 3:30 randomised feasibility trial 
BMC Public Health  2015;15:156.
Background
Many children do not engage in recommended levels of physical activity (PA), highlighting the need to find ways to increase children’s PA. Process evaluations play an important role in improving the science of randomised controlled trials. We recently reported the results of the Action 3:30 cluster randomised feasibility trial illustrating higher levels of moderate to vigorous intensity PA among boys but not girls. The aim of this paper is to report the process evaluation results including intervention fidelity, implementation, context and how intervention components and trial design could be improved before proceeding to a definitive RCT.
Methods
Children’s session enjoyment was assessed every two weeks. Reasons for non-attendance were provided by questionnaire at the end of the intervention. Post intervention interviews were held with participating teaching assistants (TAs) and school key contacts (KCs), and focus groups were conducted with children in all 10 intervention schools. Interviews and focus groups examined how recruitment and session attendance might be improved and established which elements of the programme that were and were not well received.
Results
Data indicated good intervention fidelity with TA’s adopting enjoyment-focussed teaching styles and the sessions improving children’s skills and self-esteem. Several positive aspects of implementation were identified, including high session variety, the opportunity to work in teams, the child-led sessions and the engaging leader style. In terms of context there was evidence that TA’s faced difficulties managing challenging behaviour and that further training in this area was needed. TAs and KCs felt that recruitment could be improved by providing taster sessions during PE lessons and clarifying the days that the clubs would run at the point of recruitment. The programme could be improved to enhance interest for girls, by including training for managing disruptive behaviour and making some activities more age-group appropriate.
Conclusions
Action 3.30 showed promise but could be improved by ensuring age appropriate activities, providing more appeal to girls and improving recruitment through taster sessions and early establishment of days of the week it is to be offered on.
Trial registration
ISRCTN58502739.
Electronic supplementary material
The online version of this article (doi:10.1186/s12889-015-1501-3) contains supplementary material, which is available to authorized users.
doi:10.1186/s12889-015-1501-3
PMCID: PMC4340639  PMID: 25879810
Physical activity; Intervention process evaluation; Interview; Focus group; Children
10.  The Community In-Reach and Care Transition (CIRACT) clinical and cost-effectiveness study: study protocol for a randomised controlled trial 
Trials  2015;16:41.
Background
Older people represent a significant proportion of patients admitted to hospital. Their care compared to younger patients is more challenging, length of stay is longer, risk of hospital-acquired problems higher and the risk of being re-admitted within 28 days greater. This study aims to compare a Community In-Reach and Care Transition (CIRACT) service with Traditional Hospital Based rehabilitation (THB-Rehab) provided to the older person. The CIRACT service differs from the THB-rehab service in that they are able to provide more intensive hospital rehabilitation, visiting patients daily, and are able to continue with the patient’s rehabilitation following discharge allowing a seamless, integrated discharge working alongside community providers. A pilot comparing the two services showed that the CIRACT service demonstrated reduced length of stay and reduced re-admission rates when analysed over a four-month period.
Methods/Design
This trial will evaluate the clinical and cost-effectiveness of the CIRACT service, conducted as a randomised controlled trial (RCT) with an integral qualitative mechanism and action study designed to provide the explanatory and theoretical components on how the CIRACT service compares to current practice. The RCT element consists of 240 patients over 70 years of age, being randomised to either the THB therapy group or the CIRACT service following an unplanned hospital admission. The primary outcome will be hospital length of stay from admission to discharge from the general medical elderly care ward. Additional outcome measures including the Barthel Index, Charlson Co-morbidity Scale, EuroQoL-5D and the modified Client Service Receipt Inventory will be assessed at the time of recruitment and repeated at 91 days post-discharge. The qualitative mechanism and action study will involve a systematic programme of organisational profiling, observations of work processes, interviews with key informants and care providers and tracking of participants. In addition, a within-trial economic evaluation will be undertaken comparing the CIRACT and THB-rehab services to determine cost-effectiveness.
Discussion
The outcome of the study will inform clinical decision-making, with respect to allocation of resources linked to hospital discharge planning and re-admissions, in a resource intensive and growing group of patients.
Trial registration
Registered with the ISRCTN registry (ISCRCTN94393315) on 25 April 2013 (version 3.1, 11 September 2014).
Electronic supplementary material
The online version of this article (doi:10.1186/s13063-015-0551-2) contains supplementary material, which is available to authorized users.
doi:10.1186/s13063-015-0551-2
PMCID: PMC4327808  PMID: 25886822
Rehabilitation; In-reach; Community; In-patients; Older people
11.  TElehealth in CHronic disease: mixed-methods study to develop the TECH conceptual model for intervention design and evaluation 
BMJ Open  2015;5(2):e006448.
Objective
To develop a conceptual model for effective use of telehealth in the management of chronic health conditions, and to use this to develop and evaluate an intervention for people with two exemplar conditions: raised cardiovascular disease risk and depression.
Design
The model was based on several strands of evidence: a metareview and realist synthesis of quantitative and qualitative evidence on telehealth for chronic conditions; a qualitative study of patients’ and health professionals’ experience of telehealth; a quantitative survey of patients’ interest in using telehealth; and review of existing models of chronic condition management and evidence-based treatment guidelines. Based on these evidence strands, a model was developed and then refined at a stakeholder workshop. Then a telehealth intervention (‘Healthlines’) was designed by incorporating strategies to address each of the model components. The model also provided a framework for evaluation of this intervention within parallel randomised controlled trials in the two exemplar conditions, and the accompanying process evaluations and economic evaluations.
Setting
Primary care.
Results
The TElehealth in CHronic Disease (TECH) model proposes that attention to four components will offer interventions the best chance of success: (1) engagement of patients and health professionals, (2) effective chronic disease management (including subcomponents of self-management, optimisation of treatment, care coordination), (3) partnership between providers and (4) patient, social and health system context. Key intended outcomes are improved health, access to care, patient experience and cost-effective care.
Conclusions
A conceptual model has been developed based on multiple sources of evidence which articulates how telehealth may best provide benefits for patients with chronic health conditions. It can be used to structure the design and evaluation of telehealth programmes which aim to be acceptable to patients and providers, and cost-effective.
doi:10.1136/bmjopen-2014-006448
PMCID: PMC4322202  PMID: 25659890
PRIMARY CARE
12.  Pilot study to evaluate a tailored text message intervention for pregnant smokers (MiQuit): study protocol for a randomised controlled trial 
Trials  2015;16:29.
Background
Smoking in pregnancy is a public health problem. Self-help smoking cessation support can help pregnant women to stop smoking, but the effects of delivering this kind of support via SMS text message are not known. A previous randomised controlled trial (RCT) demonstrated the feasibility and acceptability of providing such support to pregnant smokers using an automated, tailored text message intervention called MiQuit. This larger RCT will estimate key parameters for and will test the feasibility of delivering a major trial run within the United Kingdom National Health Service settings aimed at providing definitive evidence on the utility of MiQuit for helping pregnant smokers to stop.
Methods/Design
This will be a multi-centre, parallel group RCT. Participants are being identified in 16 English antenatal care settings and must be >16 years old, pregnant, <25 weeks gestation, smoke >1 daily cigarette, have smoked >5 daily cigarettes before pregnancy, and able to understand texts in English. After consenting and the collection of baseline data, participants are randomised to control or intervention groups in a 1:1 ratio; randomisation is stratified by trial site and gestation and employs computer-generated pseudo-random code using random permuted blocks of randomly varying size, and held on a secure server. All participants receive a National Health Service (NHS) leaflet aimed at helping them to stop smoking. Intervention group women also receive the 12-week MiQuit programme of tailored, supportive, interactive text message, self-help cessation support. Women are followed up by telephone 4 weeks after randomisation and at 36 weeks gestation. The study aims to recruit 400 women, and with this sample we will be able to estimate trial centres’ recruitment rates to within +/−1% (margin of error = half width of 95% confidence interval); individual trial groups’ ascertainment of rates for smoking outcomes between 4 weeks after randomisation until approximately 36 weeks gestation to within +/−4%, and across both groups, the combined cessation rate at 36 weeks +/−3%.
Discussion
Pilot trial completion will provide data to facilitate planning for a definitive trial investigating whether MiQuit works for smoking cessation in pregnancy.
Trial registration
ClinicalTrials.gov NCT02043509 Registered 14 January 2014.
doi:10.1186/s13063-014-0546-4
PMCID: PMC4318454  PMID: 25622639
Smoking cessation; Pregnancy; Self-help; Randomised controlled trial; Protocol
13.  Rehabilitation of Memory following Brain Injury (ReMemBrIn): study protocol for a randomised controlled trial 
Trials  2015;16:6.
Background
Impairments of memory are commonly reported by people with traumatic brain injuries (TBI). Such deficits are persistent, debilitating, and can severely impact quality of life. Currently, many do not routinely receive follow-up appointments for residual memory problems following discharge.
Methods/Design
This is a multi-centre, randomised controlled trial investigating the clinical and cost-effectiveness of a group-based memory rehabilitation programme. Three hundred and twelve people with a traumatic brain injury will be randomised from four centres. Participants will be eligible if they had a traumatic brain injury more than 3 months prior to recruitment, have memory problems, are 18 to 69 years of age, are able to travel to one of our centres and attend group sessions, and are able to give informed consent. Participants will be randomised in clusters of 4 to 6 to the group rehabilitation intervention or to usual care. Intervention groups will receive 10 weekly sessions of a manualised memory rehabilitation programme, which has been developed in previous pilot studies. The intervention will include restitution strategies to retrain impaired memory functions and compensation strategies to enable participants to cope with their memory problems. All participants will receive a follow-up postal questionnaire and an assessment by a research assistant at 6 and 12 months post-randomisation. The primary outcome is the Everyday Memory Questionnaire at 6 months. Secondary outcomes include the Rivermead Behavioural Memory Test-3, General Health Questionnaire-30, health related quality of life, cost-effectiveness analysis determined by the EQ-5D and a service use questionnaire, individual goal attainment, European Brain Injury Questionnaire (patient and relative versions), and the Everyday Memory Questionnaire-relative version. The primary analysis will be based on intention to treat. A mixed-model regression analysis of the Everyday Memory Questionnaire at 6 months will be used to estimate the effect of the group memory rehabilitation programme.
Discussion
The study will hopefully provide robust evidence regarding the clinical and cost-effectiveness of a group-based memory rehabilitation intervention for civilians and military personnel following TBI. We discuss our decision-making regarding choice of outcome measures and control group, and the unique challenges to recruiting people with memory problems to trials.
Trial registration
ISRCTN65792154; Date: 18 October 2012
doi:10.1186/1745-6215-16-6
PMCID: PMC4326469  PMID: 25559090
Traumatic brain injury; Memory; Cognitive rehabilitation; Randomised controlled trial; Cost-effectiveness
14.  Randomised feasibility trial of a teaching assistant led extracurricular physical activity intervention for 9 to 11 year olds: Action 3:30 
Background
Extracurricular programmes could provide a mechanism to increase the physical activity (PA) of primary-school-aged children. The aim of this feasibility study was to examine whether the Action 3:30 intervention, which is delivered by teaching assistants, holds promise as a means of increasing the PA of Year 5 and 6 children.
Methods
A cluster randomised feasibility trial was conducted in 20 primary schools. Ten schools received the Action 3:30 intervention and 10 schools were allocated to the control arm. The intervention was 40 one-hour sessions, delivered twice a week by teaching assistants. The proportion of participants recruited per school was calculated. Session delivery and session attendance was calculated for intervention schools. Weekday and after-school (3.30 to 8.30 pm) moderate to vigorous intensity physical (MVPA) was assessed by accelerometer at baseline (T0), during the last few weeks of the intervention (T1) and four months after the intervention had ended (T2). The costs of delivering the intervention were estimated.
Results
Five intervention schools ran all 40 of the intended sessions. Of the remaining five, three ran 39, one ran 38 and one ran 29 sessions. Mean attendance was 53%. The adjusted difference in weekday MVPA at T1 was 4.3 minutes (95% CI −2.6 to 11.3). Sex-stratified analyses indicated that boys obtained 8.6 more minutes of weekday MVPA than the control group (95% CI 2.8 to 14.5) at T1 with no effect for girls (0.15 minutes, 95% CI −9.7 to 10.0). There was no evidence that participation in the programme increased MVPA once the club sessions ceased (T2). The indicative average cost of this intervention was £2,425 per school or £81 per participating child during its first year and £1,461 per school or £49 per participating child thereafter.
Conclusions
The effect of the Action 3:30 intervention was comparable to previous physical activity interventions but further analysis indicated that there was a marked sex difference with a positive impact on boys and no evidence of an effect on girls. The Action 3:30 intervention holds considerable promise but more work is needed to enhance the effectiveness of the intervention, particularly for girls.
Trial registration
ISRCTN58502739
doi:10.1186/s12966-014-0114-z
PMCID: PMC4172904  PMID: 25209323
Teaching assistant; Feasibility trial; Intervention; Children; Physical activity
15.  Are People With Chronic Diseases Interested in Using Telehealth? A Cross-Sectional Postal Survey 
Background
There is growing interest in telehealth—the use of technology to support the remote delivery of health care and promote self-management—as a potential alternative to face-to-face care for patients with chronic diseases. However, little is known about what precipitates interest in the use of telehealth among these patients.
Objective
This survey forms part of a research program to develop and evaluate a telehealth intervention for patients with two exemplar chronic diseases: depression and raised cardiovascular disease (CVD) risk. The survey was designed to explore the key factors that influence interest in using telehealth in these patient groups.
Methods
Thirty-four general practices were recruited from two different regions within England. Practice records were searched for patients with (1) depression (aged 18+ years) or (2) 10-year risk of CVD ≥20% and at least one modifiable risk factor (aged 40-74 years). Within each general practice, 54 patients in each chronic disease group were randomly selected to receive a postal questionnaire. Questions assessed five key constructs: sociodemographics, health needs, difficulties accessing health care, technology-related factors (availability, confidence using technology, perceived benefits and drawbacks of telehealth), and satisfaction with prior use of telehealth. Respondents also rated their interest in using different technologies for telehealth (phone, email and Internet, or social media). Relationships between the key constructs and interest in using the three mediums of telehealth were examined using multivariable regression models.
Results
Of the 3329 patients who were sent a study questionnaire, 44.40% completed it (872/1740, 50.11% CVD risk; 606/1589, 38.14% depression). Overall, there was moderate interest in using phone-based (854/1423, 60.01%) and email/Internet-based (816/1425, 57.26%) telehealth, but very little interest in social media (243/1430, 16.99%). After adjusting for health needs, access difficulties, technology-related factors, and prior use of telehealth, interest in telehealth had largely no association with sociodemographic variables. For both patient groups and for each of the three technology mediums, the most important constructs related to interest in telehealth were having the confidence to use the associated technology, as well as perceiving greater advantages and fewer disadvantages from using telehealth. To illustrate, greater confidence using phone technologies (b=.16, 95% CI 0.002-0.33), while also perceiving more benefits (b=.31, 95% CI 0.21-0.40) and fewer drawbacks (b=-.23, 95% CI -0.28 to -0.17) to using telehealth were associated with more interest in using phone-based telehealth technologies for patients with depression.
Conclusions
There is widespread interest in using phone-based and email/Internet-based telehealth among patients with chronic diseases, regardless of their health status, access difficulties, age, or many other sociodemographic factors. This interest could be increased by helping patients gain confidence using technologies and through highlighting benefits and addressing concerns about telehealth. While the same pattern exists for social media telehealth, interest in using these technologies is minimal.
doi:10.2196/jmir.3257
PMCID: PMC4034113  PMID: 24811914
telehealth; Internet; technology; cardiovascular diseases; depression; mental health; chronic disease; survey methodology; patient acceptance of health care
16.  School travel mode, parenting practices and physical activity among UK Year 5 and 6 children 
BMC Public Health  2014;14:370.
Background
School travel mode and parenting practices have been associated with children’s physical activity (PA). The current study sought to examine whether PA parenting practices differ by school travel mode and whether school travel mode and PA parenting practices are associated with PA.
Methods
469 children (aged 9-11) wore accelerometers from which mean weekday and after-school (3.30 to 8.30 pm) minutes of moderate-to-vigorous intensity PA (MVPA) and counts per minute (CPM) were derived. Mode of travel to and from school (passive vs. active) and PA parenting practices (maternal and paternal logistic support and modelling behaviour) were child-reported.
Results
Children engaged in an average of 59.7 minutes of MVPA per weekday. Active travel to school by girls was associated with 5.9 more minutes of MVPA per day compared with those who travelled to school passively (p = 0.004). After-school CPM and MVPA did not differ by school travel mode. There was no evidence that physical activity parenting practices were associated with school travel mode.
Conclusions
For girls, encouraging active travel to school is likely to be important for overall PA. Further formative research may be warranted to understand how both parental logistic support and active travel decisions are operationalized in families as a means of understanding how to promote increased PA among pre-adolescent children.
doi:10.1186/1471-2458-14-370
PMCID: PMC3996489  PMID: 24739338
Physical activity; Travel; Parenting; Children; Adolescents
17.  Health services changes: is a run-in period necessary before evaluation in randomised clinical trials? 
Trials  2014;15:41.
Background
Most randomised clinical trials (RCTs) testing a new health service do not allow a run-in period of consolidation before evaluating the new approach. Consequently, health professionals involved may feel insufficiently familiar or confident, or that new processes or systems that are integral to the service are insufficiently embedded in routine care prior to definitive evaluation in a RCT. This study aimed to determine the optimal run-in period for a new physiotherapy-led telephone assessment and treatment service known as PhysioDirect and whether a run-in was needed prior to evaluating outcomes in an RCT.
Methods
The PhysioDirect trial assessed whether PhysioDirect was as effective as usual care. Prior to the main trial, a run-in of up to 12 weeks was permitted to facilitate physiotherapists to become confident in delivering the new service. Outcomes collected from the run-in and main trial were length of telephone calls within the PhysioDirect service and patients’ physical function (SF-36v2 questionnaire) and Measure Yourself Medical Outcome Profile v2 collected at baseline and six months. Joinpoint regression determined how long it had taken call times to stabilise. Analysis of covariance determined whether patients’ physical function at six months changed from the run-in to the main trial.
Results
Mean PhysioDirect call times (minutes) were higher in the run-in (31 (SD: 12.6)) than in the main trial (25 (SD: 11.6)). Each physiotherapist needed to answer 42 (95% CI: 20,56) calls for their mean call time to stabilise at 25 minutes per call; this took a minimum of seven weeks. For patients’ physical function, PhysioDirect was equally clinically effective as usual care during both the run-in (0.17 (95% CI: -0.91,1.24)) and main trial (-0.01 (95% CI: -0.80,0.79)).
Conclusions
A run-in was not needed in a large trial testing PhysioDirect services in terms of patient outcomes. A learning curve was evident in the process measure of telephone call length. This decreased during the run-in and stabilised prior to commencement of the main trial. Future trials should build in a run-in if it is anticipated that learning would have an effect on patient outcome.
Trial registration
Current Controlled Trials, ISRCTN55666618
doi:10.1186/1745-6215-15-41
PMCID: PMC3933371  PMID: 24479729
Health services; Learning curve; Randomised clinical trial; Run-in period
18.  Effectiveness and cost-effectiveness of a telehealth intervention to support the management of long-term conditions: study protocol for two linked randomized controlled trials 
Trials  2014;15:36.
Background
As the population ages, more people are suffering from long-term health conditions (LTCs). Health services around the world are exploring new ways of supporting people with LTCs and there is great interest in the use of telehealth: technologies such as the Internet, telephone and home self-monitoring.
Methods/Design
This study aims to evaluate the effectiveness and cost-effectiveness of a telehealth intervention delivered by NHS Direct to support patients with LTCs. Two randomized controlled trials will be conducted in parallel, recruiting patients with two exemplar LTCs: depression or raised cardiovascular disease (CVD) risk. A total of 1,200 patients will be recruited from approximately 42 general practices near Bristol, Sheffield and Southampton, UK. Participants will be randomly allocated to either usual care (control group) or usual care plus the NHS Direct Healthlines Service (intervention group). The intervention is based on a conceptual model incorporating promotion of self-management, optimisation of treatment, coordination of care and engagement of patients and general practitioners. Participants will be provided with tailored help, combining telephone advice from health information advisors with support to use a range of online resources. Participants will access the service for 12 months. Outcomes will be collected at baseline, four, eight and 12 months for the depression trial and baseline, six and 12 months for the CVD risk trial. The primary outcome will be the proportion of patients responding to treatment, defined in the depression trial as a PHQ-9 score <10 and an absolute reduction in PHQ-9 ≥5 after 4 months, and in the CVD risk trial as maintenance or reduction of 10-year CVD risk after 12 months. The study will also assess whether the intervention is cost-effective from the perspective of the NHS and personal social services. An embedded qualitative interview study will explore healthcare professionals’ and patients’ views of the intervention.
Discussion
This study evaluates a complex telehealth intervention which combines evidence-based components and is delivered by an established healthcare organisation. The study will also analyse health economic information. In doing so, the study hopes to address some of the limitations of previous research by demonstrating the effectiveness and cost-effectiveness of a real world telehealth intervention.
Trial registration
Current Controlled Trials: Depression trial ISRCTN14172341 and cardiovascular disease risk trial ISRCTN27508731.
doi:10.1186/1745-6215-15-36
PMCID: PMC3906859  PMID: 24460845
Cardiovascular disease risk; Depression; Randomized controlled trial; Telehealth
19.  Comparing specialist medical care with specialist medical care plus the Lightning Process® for chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME): study protocol for a randomised controlled trial (SMILE Trial) 
Trials  2013;14:444.
Background
Chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME) is a relatively common and potentially serious condition with a limited evidence base for treatment. Specialist treatment for paediatric CFS/ME uses interventions recommended by National Institute for Health and Clinical Excellence (NICE) including cognitive behavioural therapy, graded exercise therapy and activity management. The Lightning Process® (LP) is a trademarked intervention derived from osteopathy, life-coaching and neuro-linguistic programming, delivered over three consecutive days as group sessions. Although over 250 children with CFS/ME attend LP courses each year, there are no reported studies on the effectiveness or cost-effectiveness.
Methods
This pragmatic randomised controlled trial is set within a specialist paediatric CFS/ME service in the south west of England. Children and young people with CFS/ME (n = 80 to 112), aged 12 to 18 years old will be randomised to specialist medical care (SMC) or SMC plus the LP. The primary outcome will be physical function (SF-36 physical function short form) and fatigue (Chalder Fatigue Scale).
Discussion
This study will tell us whether adding the LP to SMC is effective and cost-effective compared to SMC alone. This study will also provide detailed information on the implementation of the LP and SMC.
Trial registration
Current Controlled Trials ISRCTN81456207 (31 July 2012).
doi:10.1186/1745-6215-14-444
PMCID: PMC3879423  PMID: 24370208
Fatigue; Paediatrics; Chronic fatigue syndrome; Myalgic encephalomyelitis
20.  The feasibility and acceptability of conducting a trial of specialist medical care and the Lightning Process in children with chronic fatigue syndrome: feasibility randomized controlled trial (SMILE study) 
Trials  2013;14:415.
Background
Chronic fatigue syndrome (CFS) or myalgic encephalomyelitis (ME) is relatively common in children with limited evidence for treatment. The Phil Parker Lightning Process (LP) is a trademarked intervention, which >250 children use annually. There are no reported studies investigating the effectiveness or possible side effects of LP.
Methods
The trial population was drawn from the Bath and Bristol NHS specialist paediatric CFS or ME service. The study was designed as a pilot randomized trial with children (aged 12 to 18 years) comparing specialist medical care with specialist medical care plus the Lightning Process. Integrated qualitative methodology was used to explore the feasibility and acceptability of the recruitment, randomization and interventions.
Results
A total of 56 children were recruited from 156 eligible children (1 October 2010 to 16 June 2012). Recruitment, randomization and both interventions were feasible and acceptable. Participants suggested changes to improve feasibility and acceptability and we incorporated the following in the trial protocol: stopped collecting 6-week outcomes; introduced a second reminder letter; used phone calls to collect primary outcomes from nonresponders; informed participants about different approaches of each intervention and changed our recommendation for the primary outcome for the full study from school attendance to disability (SF-36 physical function subscale) and fatigue (Chalder Fatigue Scale).
Conclusions
Conducting randomized controlled trials (RCTs) to investigate an alternative treatment such as LP is feasible and acceptable for children with CFS or ME. Feasibility studies that incorporate qualitative methodology enable changes to be made to trial protocols to improve acceptability to participants. This is likely to improve recruitment rate and trial retention.
Trial registration
Feasibility study first randomization: 29 September 2010.
Trial registration: Current Controlled Trials ISRCTN81456207 (31 July 2012).
Full trial first randomization: 19 September 2012.
doi:10.1186/1745-6215-14-415
PMCID: PMC4235039  PMID: 24304689
21.  Self-harm in young adolescents (12–16 years): onset and short-term continuation in a community sample 
BMC Psychiatry  2013;13:328.
Background
To investigate the prevalence of self-harm in young adolescents and factors associated with onset and continuity over a one year period.
Method
Prospective longitudinal study. Participants were young adolescents (n = 3964) aged 12–16 years attending 8 secondary schools in the Midlands and South West of England.
Results
Over a one year period 27% of young adolescents reported thoughts of self-harm and 15% reported at least one act of self-harm. Of those who self-harmed, less than one in five (18%) had sought help for psychological problems of anxiety or depression. Compared with boys, girls were at increased risk of developing thoughts (OR 1.61, 95% CI 1.26-2.06) and acts (OR 1.40, 95% CI 1.06-1.84) of self-harm, particularly amongst those girls in school year 9 (aged 13/14, thoughts adjusted Odds Ratio (aOR) 1.97, 95% CI 1.27-3.04; acts aOR 2.59, 95% CI 1.52-4.41). Of those reporting thoughts of self-harm at baseline, 60% also reported these thoughts at follow-up. Similarly 55% of those who reported an act of self-harm at baseline also reported that they had self-harmed at follow-up. Insecure peer relationships increased the likelihood that boys and girls would develop self-harming behaviours, as did being bullied for boys. Low mood was associated with the development of self-harming thoughts and behaviours for boys and girls, whilst a strong sense of school membership was associated with a reduced risk of developing thoughts of self-harm for boys and increased the likelihood of self-harming thoughts and behaviours ceasing for girls.
Conclusion
Self harm in young adolescents is common with one in four reporting self-harming thoughts and one in six engaging in self-harming behaviour over a one year period. Self-harm is already established by 12/13 years of age and for over half of our sample, self-harming thoughts and behaviour persisted over the year. Secure peer and strong school relationships were associated with less self-harm. Few seek help for psychological problems, suggesting a need to increase awareness amongst all professionals who work with young adolescents about self-harm and associated risk factors.
doi:10.1186/1471-244X-13-328
PMCID: PMC4219511  PMID: 24294921
Self-harm; Young adolescents; Onset; Continuity
23.  Depression Symptom Trajectories and Associated Risk Factors among Adolescents in Chile  
PLoS ONE  2013;8(10):e78323.
Adolescence is a key period for studying the development of depression, with studies in Europe and North America showing a pattern of elevated risk that begins in early adolescence and continues to increase as adolescents age. Few studies have examined the course of adolescent depression and associated risk factors in low and middle-income countries. This longitudinal cohort study examined depression symptom trajectories and risk factors in a sample of socio-economically disadvantaged adolescents in Chile (n = 2,508). Data were collected over an 18-month period as part of a clinical trial for secondary students aged 12 to 18 (median age 14). Clinical levels of depression were prevalent in this sample at baseline (35% for girls and 28% for boys); yet latent growth models of symptom trajectories revealed a pattern of decreasing symptoms over time. There was evidence of an anxiety-depression developmental pathway for girls, with elevated anxiety levels initially predicting poorer depression outcomes later on. Poor problem-solving skills were associated with initial depression levels but did not predict the course of depressive symptoms. Critically, the declining symptom trajectories raise important methodological issues regarding the effects of repeated assessment in longitudinal studies.
doi:10.1371/journal.pone.0078323
PMCID: PMC3795668  PMID: 24147131
24.  Factors associated with the development of self-harm amongst a socio-economically deprived cohort of adolescents in Santiago, Chile 
Purpose
Studies carried out in the West indicate that the incidence of self-harm (SH) is particularly high amongst adolescents, but few studies have investigated its incidence and aetiology in low-income countries. The purpose of this study was to investigate risk factors associated with new onset episodes of SH, amongst Chilean adolescents from low socio-economic backgrounds.
Methods
Prospective cohort study nested within a cluster randomised controlled trial. A 6-month follow-up for 2,042 adolescents, median age 14 years, from socio-economically deprived areas of Santiago, Chile.
Results
The lifetime prevalence of SH was 23 %. The incidence rate of SH at 6 months was 14 % amongst those reporting no SH at baseline. In multivariable analyses, risk factors for incident SH include depressive symptoms, suicidal thoughts, poor problem-solving skills and cannabis misuse.
Conclusions
The prevalence and incidence of SH in this socio-economically deprived sample differed highly according to gender. Poor problem-solving skills, suicidal thoughts, and cannabis misuse were associated with onset of SH.
Electronic supplementary material
The online version of this article (doi:10.1007/s00127-013-0767-y) contains supplementary material, which is available to authorized users.
doi:10.1007/s00127-013-0767-y
PMCID: PMC3969808  PMID: 24097260
Self-harm; Adolescents; Depression; Prospective; Deprived
25.  A pragmatic randomised controlled trial of ‘PhysioDirect’ telephone assessment and advice services for patients with musculoskeletal problems: economic evaluation 
BMJ Open  2013;3(10):e003406.
Objectives
To compare the cost-effectiveness of PhysioDirect with usual physiotherapy care for patients with musculoskeletal problems.
Design
(1) Cost-consequences comparing cost to the National Health Service (NHS), to patients, and the value of lost productivity with a range of outcomes. (2) Cost-utility analysis comparing cost to the NHS with Quality-Adjusted Life Years (QALYs).
Setting
Four physiotherapy services in England.
Participants
Adults (18+) referred by their general practitioner or self-referred for physiotherapy.
Interventions
PhysioDirect involved telephone assessment and advice followed by face-to-face care if needed. Usual care patients were placed on a waiting list for face-to-face care.
Primary and secondary outcomes
Primary clinical outcome: physical component summary from the SF-36v2 at 6 months. Also included in the cost-consequences: Measure Yourself Medical Outcomes Profile; a Global Improvement Score; response to treatment; patient satisfaction; waiting time. Outcome for the cost-utility analysis: QALYs.
Results
2249 patients took part (1506 PhysioDirect; 743 usual care). (1) Cost-consequences: there was no evidence of a difference between the two groups in the cost of physiotherapy, other NHS services, personal costs or value of time off work. Outcomes were also similar. (2) Cost-utility analysis based on complete cases (n=1272). Total NHS costs, including the cost of physiotherapy were higher in the PhysioDirect group by £19.30 (95% CI −£37.60 to £76.19) and there was a QALY gain of 0.007 (95% CI −0.003 to 0.016). The incremental cost-effectiveness ratio was £2889 and the net monetary benefit at λ=£20 000 was £117 (95% CI −£86 to £310).
Conclusions
PhysioDirect may be a cost-effective alternative to usual physiotherapy care, though only with careful management of staff time. Physiotherapists providing the service must be more fully occupied than was possible under trial conditions: consideration should be given to the scale of operation, opening times of the service and flexibility in the methods used to contact patients.
doi:10.1136/bmjopen-2013-003406
PMCID: PMC3796275  PMID: 24091423
economic evaluation; physiotherapy; telehealth; PRIMARY CARE; costs & cost analysis

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