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.
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.
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.
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.
Rehabilitation; In-reach; Community; In-patients; Older people
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.
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.
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.
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.
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.
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%.
Pilot trial completion will provide data to facilitate planning for a definitive trial investigating whether MiQuit works for smoking cessation in pregnancy.
ClinicalTrials.gov NCT02043509 Registered 14 January 2014.
Smoking cessation; Pregnancy; Self-help; Randomised controlled trial; Protocol
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.
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.
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.
ISRCTN65792154; Date: 18 October 2012
Traumatic brain injury; Memory; Cognitive rehabilitation; Randomised controlled trial; Cost-effectiveness
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.
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.
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.
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.
Teaching assistant; Feasibility trial; Intervention; Children; Physical activity
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.
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.
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.
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.
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.
telehealth; Internet; technology; cardiovascular diseases; depression; mental health; chronic disease; survey methodology; patient acceptance of health care
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.
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.
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.
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.
Physical activity; Travel; Parenting; Children; Adolescents
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.
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.
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)).
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.
Current Controlled Trials, ISRCTN55666618
Health services; Learning curve; Randomised clinical trial; Run-in period
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.
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.
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.
Current Controlled Trials: Depression trial ISRCTN14172341 and cardiovascular disease risk trial ISRCTN27508731.
Cardiovascular disease risk; Depression; Randomized controlled trial; Telehealth
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.
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).
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.
Current Controlled Trials ISRCTN81456207 (31 July 2012).
Fatigue; Paediatrics; Chronic fatigue syndrome; Myalgic encephalomyelitis
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.
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.
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).
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.
Feasibility study first randomization: 29 September 2010.
Trial registration: Current Controlled Trials ISRCTN81456207 (31 July 2012).
Full trial first randomization: 19 September 2012.
To investigate the prevalence of self-harm in young adolescents and factors associated with onset and continuity over a one year period.
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.
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.
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.
Self-harm; Young adolescents; Onset; Continuity
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.
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.
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.
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.
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.
Self-harm; Adolescents; Depression; Prospective; Deprived
To compare the cost-effectiveness of PhysioDirect with usual physiotherapy care for patients with musculoskeletal problems.
(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).
Four physiotherapy services in England.
Adults (18+) referred by their general practitioner or self-referred for physiotherapy.
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.
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).
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.
economic evaluation; physiotherapy; telehealth; PRIMARY CARE; costs & cost analysis
The Nurse Family Partnership programme was developed in the USA where it is made available to pregnant young mothers in some socially deprived geographic areas. The related Family Nurse Partnership programme was introduced in England by the Department of Health in 2006 with the aim of improving outcomes for the health, wellbeing and social circumstances of young first-time mothers and their children.
Methods / design
This multi-centre individually randomised controlled trial will recruit 1600 participants from 18 Primary Care Trusts in England, United Kingdom. The trial will evaluate the effectiveness of Family Nurse Partnership programme and usual care versus usual care for nulliparous pregnant women aged 19 or under, recruited by 24 weeks gestation and followed until the child’s second birthday. Data will be collected from participants at baseline, 34-36 weeks gestation, 6, 12, 18 and 24 months following birth. Routine clinical data will be collected from maternity, primary care and hospital episodes statistics. Four primary outcomes are to be reported from the trial: birth weight; prenatal tobacco use; child emergency attendances and/or admissions within two years of birth; second pregnancy within two years of first birth.
This trial will evaluate the effectiveness and cost effectiveness of the Family Nurse Partnership in England. The findings will provide evidence on pregnancy and early childhood programme outcomes for policy makers, health professionals and potential recipients in three domains (pregnancy and birth, child health and development, and parental life course and self-sufficiency) up to the child’s second birthday.
Trial registration number: ISRCTN 23019866
Pregnancy in adolescence; Prenatal care; Maternal health; Home visiting; Birth weight; Smoking cessation; Child maltreatment; Family nurse partnership; Early years prevention; Randomised controlled trial
The naturally-occurring omega (ω)-3 polyunsaturated fatty acid (PUFA) eicosapentaenoic acid (EPA) reduces colorectal adenoma (polyp) number and size in patients with familial adenomatous polyposis. The safety profile and potential cardiovascular benefits associated with ω-3 PUFAs make EPA a strong candidate for colorectal cancer (CRC) chemoprevention, alone or in combination with aspirin, which itself has recognized anti-CRC activity. Colorectal adenoma number and size are recognized as biomarkers of future CRC risk and are established as surrogate end-points in CRC chemoprevention trials.
The seAFOod Polyp Prevention Trial is a randomized, double-blind, placebo-controlled, 2 × 2 factorial ‘efficacy’ study, which will determine whether EPA prevents colorectal adenomas, either alone or in combination with aspirin. Participants are 55–73 year-old patients, who have been identified as ‘high risk’ (detection of ≥5 small adenomas or ≥3 adenomas with at least one being ≥10 mm in diameter) at screening colonoscopy in the English Bowel Cancer Screening Programme (BCSP). Exclusion criteria include the need for more than one repeat endoscopy within the three-month BCSP screening period, malignant change in an adenoma, regular use of aspirin or non-aspirin non-steroidal anti-inflammatory drugs, regular use of fish oil supplements and concomitant warfarin or anti-platelet agent therapy. Patients are randomized to either EPA-free fatty acid 1 g twice daily or identical placebo AND aspirin 300 mg once daily or identical placebo, for approximately 12 months. The primary end-point is the number of participants with one or more adenomas detected at routine one-year BCSP surveillance colonoscopy. Secondary end-points include the number of adenomas (total and ‘advanced’) per patient, the location (left versus right colon) of colorectal adenomas and the number of participants re-classified as ‘intermediate risk’ for future surveillance. Exploratory end-points include levels of bioactive lipid mediators such as ω-3 PUFAs, resolvin E1 and PGE-M in plasma, urine, erythrocytes and rectal mucosa in order to gain insights into the mechanism(s) of action of EPA and aspirin, alone and in combination, as well as to discover predictive biomarkers of chemopreventive efficacy. The recruitment target is 904 patients.
Current Controlled Trials ISRCTN05926847
Aspirin; Colorectal adenoma; Colorectal cancer; Eicosapentaenoic acid; Omega-3 polyunsaturated fatty acid
Self-harm is common in adolescents, but it is often unreported and undetected. Available screening tools typically ask directly about self-harm and suicidal ideation. Although in an ideal world, direct enquiry and open discussion around self-harm would be advocated, non-psychiatric professionals in community settings are often reluctant to ask about this directly and disclosure can be met with feeling of intense anxiety. Training non-specialist staff to directly ask about self-harm has limited effects suggesting that alternative approaches are required. This study investigated whether a targeted analysis of negative emotions and self-esteem could identify young adolescents at risk of self-harm in community settings.
Data were collected as part of a clinical trial from young people in school years 8–11 (aged 12–16) at eight UK secondary schools (N = 4503 at baseline, N = 3263 in prospective analysis). The Short Mood and Feelings Questionnaire, Revised Child Anxiety and Depression Scale, Rosenberg Self-Esteem Scale, personal failure (Children’s Automatic Thoughts Scale), and two items on self-harm were completed at baseline, 6 and 12 months.
Following a process of Principal Components Analysis, item reduction, and logistic regression analysis, three internally reliable factors were identified from the original measures that were independently associated with current and future self-harm; personal failure (3 items), physical symptoms of depression/anxiety (6 items), positive self-esteem (5 items). The summed score of these 14 items had good accuracy in identifying current self-harm (AUC 0.87 girls, 0.81 boys) and at six months for girls (0.81), and fair accuracy at six months for boys (AUC 0.74) and 12 months for girls (AUC 0.77).
A brief and targeted assessment of negative emotions and self-esteem, focusing on factors that are strongly associated with current and future self-harm, could potentially be used to help identify adolescents who are at risk in community settings. Further research should assess the psychometric properties of the items identified and test this approach in more diverse community contexts.
Self-harm; Screening; Adolescents; Negative emotions; Self-esteem
Many children do not meet physical activity (PA) guidelines. Extracurricular programmes could provide a mechanism to increase the PA levels of primary-school-aged children. Teaching assistants (TAs) are a valuable resource in all UK primary schools and could be trained to delivery after-school PA programmes. The aim of this feasibility study is to examine whether the Action 3:30 PA intervention, which is delivered by TAs, could be effective in increasing the PA of Year 5 and 6 children.
A feasibility trial will be conducted in 20 primary schools. Schools will be randomly assigned to intervention or control arms. Intervention schools will receive a 25-hour TA training programme for two TAs, a first-aid certificate course for two TAs; ongoing TA support; 40 one-hour session plans that can be delivered by TAs; Action 3:30 clubs that run twice a week for 20 weeks; and ten sets of parent information sheets that are distributed biweekly.
All measures will be assessed at baseline (Time 0), at the end of the intervention period (Time 1) and four months after the intervention has ended (Time 2). As this is a feasibility study, our primary interest is in estimating the recruitment of schools and children, adherence to the intervention, and completeness of data collection for outcomes and costs.
As the most likely primary outcome measure in a future definitive trial will be accelerometer-determined minutes of moderate-to-vigorous PA (MVPA) per day, participants will wear accelerometers for five days (including two weekend days). Several psychosocial variables that could act as mediators in a future trial will be assessed via a questionnaire. Process evaluations of the session attendance, perceived enjoyment and perceived exertion will be assessed during the intervention. At the end of the intervention period, qualitative assessments will be conducted to identify how the programme could be improved before proceeding to a larger trial.
The goal of the feasibility trial is to assess the potential of this innovative intervention approach and provide all the information necessary to design a cluster randomized controlled trial.
Children; Feasibility trial; Intervention; Physical activity; Teaching assistant
Depression among adolescents is common but most cases go undetected. Brief questionnaires offer an opportunity to identify probable cases but properly validated cut-off points are often unavailable, especially in non-western countries. Sex differences in the prevalence of depression become marked in adolescence and this needs to be accounted when establishing cut-off points.
This study involved adolescents attending secondary state schools in Santiago, Chile. We compared the self-reported Beck Depression Inventory-II with a psychiatric interview to ascertain diagnosis. General psychometric features were estimated before establishing the criterion validity of the BDI-II.
The BDI-II showed good psychometric properties with good internal consistency, a clear unidimensional factorial structure, and good capacity to discriminate between cases and non-cases of depression. Optimal cut-off points to establish caseness for depression were much higher for girls than boys. Sex discrepancies were primarily explained by differences in scores among those with depression rather than among those without depression.
It is essential to validate scales with the populations intended to be used with. Sex differences are often ignored when applying cut-off points, leading to substantial misclassification. Early detection of depression is essential if we think that early intervention is a clinically important goal.
Depression; Adolescents; Sex; Beck depression inventory; Screening
Instrumental deliveries are commonly performed in the United Kingdom and Ireland, with rates of 12 – 17% in most centres. Knowing the exact position of the fetal head is a pre-requisite for safe instrumental delivery. Traditionally, diagnosis of the fetal head position is made on transvaginal digital examination by delineating the suture lines of the fetal skull and the fontanelles. However, the accuracy of transvaginal digital examination can be unreliable and varies between 20% and 75%. Failure to identify the correct fetal head position increases the likelihood of failed instrumental delivery with the additional morbidity of sequential use of instruments or second stage caesarean section. The use of ultrasound in determining the position of the fetal head has been explored but is not part of routine clinical practice.
A multi-centre randomised controlled trial is proposed. The study will take place in two large maternity units in Ireland with a combined annual birth rate of 13,500 deliveries. It will involve 450 nulliparous women undergoing instrumental delivery after 37 weeks gestation. The main outcome measure will be incorrect diagnosis of the fetal head position. A study involving 450 women will have 80% power to detect a 10% difference in the incidence of inaccurate diagnosis of the fetal head position with two-sided 5% alpha.
It is both important and timely to evaluate the use of ultrasound to diagnose the fetal head position prior to instrumental delivery before routine use can be advocated. The overall aim is to reduce the incidence of incorrect diagnosis of the fetal head position prior to instrumental delivery and improve the safety of instrumental deliveries.
Current Controlled Trials ISRCTN72230496
Fetal head position; Second stage of labour; Intrapartum ultrasound; Randomised controlled trial
Many adolescent girls do not engage in sufficient physical activity (PA). This study examined the feasibility of conducting a cluster randomized controlled trial (RCT) to evaluate an after-school dance program to increase PA among 11–12 year old girls in Bristol, UK.
Three-arm, cluster RCT. Three secondary schools were assigned to intervention arm. Intervention participants received a 9-week dance program with 2, 90-minute dance classes per week. Participants at 2 control schools received incentives for data collection. Participants at 2 additional control schools received incentives and a delayed dance workshop. Accelerometer data were collected at baseline (time 0), during the last week of the dance program (time 1) and 20 weeks after the start of the study (time 2). Weekly attendance, enjoyment and perceived exertion were assessed in intervention participants. Post-study qualitative work was conducted with intervention participants and personnel.
40.1% of girls provided consent to be in the study. The mean number of girls attending at least one dance session per week ranged from 15.4 to 25.9. There was greater number of participants for whom accelerometer data were collected in control arms. The mean attendance was 13.3 sessions (maximum = 18). Perceived exertion ratings indicated that the girls did not find the sessions challenging. The dance teachers reported that the program content would benefit from revisions including less creative task time, a broader range of dance genres and improved behavioral management policies. At time 2, the 95% confidence intervals suggest between 5 and 12 minutes more weekday MVPA in the intervention group compared with the control incentives only group, and between 6 minutes fewer and 1 minute more compared with the control incentives plus workshop group. Between 14 and 24 schools would be required to detect a difference of 10 minutes in mean weekday MVPA between intervention and control groups.
It is possible to recruit 11–12 year old girls to participate in an after-school dance study. An after-school dance intervention has potential to positively affect the PA levels of 11–12 year old girls but an adequately powered RCT is required to test this intervention approach.
In developed countries, primary health care increasingly involves the care of patients with multiple chronic conditions, referred to as multimorbidity.
To describe the epidemiology of multimorbidity and relationships between multimorbidity and primary care consultation rates and continuity of care.
Design of study
Retrospective cohort study.
Random sample of 99 997 people aged 18 years or over registered with 182 general practices in England contributing data to the General Practice Research Database.
Multimorbidity was defined using two approaches: people with multiple chronic conditions included in the Quality and Outcomes Framework, and people identified using the Johns Hopkins University Adjusted Clinical Groups (ACG®) Case-Mix System. The determinants of multimorbidity (age, sex, area deprivation) and relationships with consultation rate and continuity of care were examined using regression models.
Sixteen per cent of patients had more than one chronic condition included in the Quality and Outcomes Framework, but these people accounted for 32% of all consultations. Using the wider ACG list of conditions, 58% of people had multimorbidity and they accounted for 78% of consultations. Multimorbidity was strongly related to age and deprivation. People with multimorbidity had higher consultation rates and less continuity of care compared with people without multimorbidity.
Multimorbidity is common in the population and most consultations in primary care involve people with multimorbidity. These people are less likely to receive continuity of care, although they may be more likely to gain from it.
chronic disease; comorbidity; family practice; primary health care; outcome and process assessment (healthcare); prevalence
Standards for the reporting of factorial randomised trials remain to be established. We aimed to review the quality of reporting of methodological aspects of published factorial trials of complex interventions in community settings.
We searched MEDLINE, EMBASE, PsychInfo and the Cochrane Controlled Trials Register to identify factorial randomised trials of complex interventions in community settings from January 2000 to August 2009. We also conducted a citation search of two review papers published in 2003. Data were extracted by two reviewers on 22 items relating to study design, analysis and presentation.
We identified 5941 unique titles, from which 116 full papers were obtained and 76 were included in the review. The included trials reflected a broad range of target conditions and types of intervention. The median sample size was 400 (interquartile range 191-1001). Most (88%) trials employed a 2 × 2 factorial design. Few trials (21%) explicitly stated the rationale for using a factorial design. Reporting of aspects of design, analysis or presentation specific to factorial trials was variable, but there was no evidence that reporting of these aspects was different for trials published before or after 2003. However, for CONSORT items that apply generally to the reporting of all trials, there was some evidence that later studies were more likely to report employing an intention-to-treat (ITT) approach (78% vs 52%), present appropriate between-group estimates of effect (88% vs 63%), and present standard errors or 95% confidence intervals for such estimates (78% vs 56%). Interactions between interventions and some measure of the precision associated with such effects were reported in only 14 (18%) trials.
Reports of factorial trials of complex interventions in community settings vary in the amount of information they provide regarding important methodological aspects of design and analysis. This variability supports the extension of CONSORT guidelines to include the specific reporting of factorial trials.