Full Randomised Controlled Trial Research Articles

Outcomes tested in non-pharmacological interventions in mild cognitive impairment and mild dementia: a scoping review

ObjectivesNon-pharmacological treatments are an important aspect of dementia care. A wide range of interventions have been trialled for mild dementia and mild cognitive impairment (MCI). However, the variety of outcome...

A Feasibility Cluster Randomized Controlled Trial of Individual Placement and Support (IPS) for Patients With Offending Histories.

Objective: To examine the feasibility of conducting a fully powered randomized controlled trial (RCT) of Individual Placement and Support (IPS). IPS is a form of supported employment which aims to put people into open employment quickly and in accordance with their preferences. It is delivered by employment specialists collocated within clinical teams, and provides time unlimited support for the individual and their employer, along with welfare benefits counselling. Method: A feasibility cluster RCT of treatment as usual (TAU) plus IPS versus TAU alone was conducted over 12 months among patients with offending histories in a community forensic setting in the UK. The feasibility criteria were to achieve 50% recruitment rate; 50% completion rate for IPS; 50% completion rate of all outcome measures; and 80% acceptability rating for IPS. The primary efficacy outcome was the proportion of people in open employment at 12 months. The secondary outcomes were other vocational and educational activities; Brief Psychiatric Rating Scale; Rosenberg’s Self-esteem Scale; Client Service Receipt Inventory; quality of life using the SF12-v2 and EQ5-D3; Social Functioning Questionnaire; Work Limitation Questionnaire; and reoffending. Results: Participants’ mean age was 39.2 years. The majority were male (88.9), White British (72.2), and single (72.2%). Over 72% had no higher qualification beyond secondary education; mean years in education was 10.4. Over one third had schizophrenia, one fifth had depression, and the rest had personality disorder as their primary diagnosis. Participants had a lifetime average of 7.5 convictions for 15.5 offences. The recruitment rate of all referrals was 38.3% (IPS n = 11; TAU n = 7). Completion rate for IPS was 54.5, with 45.5% acceptability rating. Completion rates for outcome measures for the groups at baseline and 12 months ranged from 22.2 to 100%. The proportion of people in open employment at 12 months were 9.1 and 0% for IPS and TAU respectively. Conclusion: It is not feasible to conduct a full RCT of IPS in community forensic settings in the UK owing to recruitment and retention difficulties. Conducting a trial of this kind requires a large pool of patients from multiple sites and longer IPS implementation and recruitment periods than those of this study. Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT02442193.

Lending an Ear: iPeer2Peer plus Teens Taking Charge online self-management to empower adolescents with arthritis in Ireland: protocol for a pilot randomised controlled trial

IntroductionJuvenile idiopathic arthritis (JIA) negatively affects adolescents’ everyday activities. To address the need for innovative, effective, convenient, low-cost psychosocial self-management programmes, we developed an Irish version of Canadian Teens Taking...

Healthy Dads, Healthy Kids UK, a weight management programme for fathers: feasibility RCT

ObjectiveTo assess (1) the feasibility of delivering a culturally adapted weight management programme, Healthy Dads, Healthy Kids United Kingdom (HDHK-UK), for fathers with overweight or obesity and their primary school-aged...

Promoting Independence in Dementia (PRIDE): protocol for a feasibility randomised controlled trial

BackgroundMemory services often see people with early stage dementia who are largely independent and able to participate in community activities but who run the risk of reducing activities and social networks. PRIDE is a self-management intervention designed to promote living well and enhance independence for people with mild dementia.This study aims to examine the feasibility of conducting a definitive randomised trial comparing the clinical and cost-effectiveness of the PRIDE intervention offered in addition to usual care or with usual care alone.Methods/designPRIDE is a parallel, two-arm, multicentre, feasibility, randomised controlled trial (RCT). Eligible participants aged 18 or over who have mild dementia (defined as a score of 0.5 or 1 on the Clinical Dementia Rating Scale) who can participate in the intervention and provide informed consent will be randomised (1:1) to treatment with the PRIDE intervention delivered in addition to usual care, or usual care only. Participants will be followed-up at 3 and 6 month’s post-randomisation. There will be an option for a supporter to join each participant. Each supporter will be provided with questionnaires at baseline and follow-ups at 3 to 6 months. Embedded qualitative research with both participants and supporters will explore their perspectives on the intervention investigating a range of themes including acceptability and barriers and facilitators to delivery and participation. The feasibility of conducting a full RCT associated with participant recruitment and follow-up of both conditions, intervention delivery including the recruitment, training, retention of PRIDE trained facilitators, clinical outcomes, intervention and resource use costs and the acceptability of the intervention and study related procedures will be examined.DiscussionThis study will assess whether a definitive randomised trial comparing the clinical and cost-effectiveness of whether the PRIDE intervention offered in addition to usual care is feasible in comparison to usual care alone, and if so, will provide data to inform the design and conduct of a future trial.Trial registrationISRCTN, ISRCTN11288961, registered on 23 October 2019, http://www.isrctn.com/ISRCTN12345678 Protocol V2.1 dated 19 June 2019.

Parental and health professional evaluations of a support service for parents of excessively crying infants

BackgroundThe ‘Surviving Crying’ study was designed to develop and provisionally evaluate a support service for parents of excessively crying babies, including its suitability for use in the United Kingdom (UK) National Health Service (NHS). The resulting service includes three materials: a website, a printed booklet, and a Cognitive Behaviour Therapy (CBT) programme delivered to parents by a qualified professional. This study aimed to measure whether parents used the materials and to obtain parents’ and NHS professionals’ evaluations of whether they are fit for purpose. Parents were asked about participating in a randomised controlled trial (RCT) to evaluate the materials fully in health service use.MethodsParticipants were 57 parents with babies they judged to be crying excessively and 96 NHS Health Visitors (HVs). Parental use and parents’ and HVs’ ratings of the Surviving Crying materials were measured.ResultsThirty four parents reported using the website, 24 the printed booklet and 24 the CBT sessions. Parents mostly accessed the website on mobile phones or tablets and use was substantial. All the parents and almost all HVs who provided data judged the materials to be helpful for parents and suitable for NHS use. If offered a waiting list control group, 85% of parents said they would have been willing to take part in a full RCT evaluation of the Surviving Crying package.Discussion and conclusionsThe findings identify the need for materials to support parents of excessively crying babies within national health services in the UK. The Surviving Crying support package appears suitable for this purpose and a full community-level RCT of the package is feasible and likely to be worthwhile. Limitations to the study and barriers to delivery of the services were identified, indicating improvements needed in future research.Trial registrationStudy Registration no. ISRCTN84975637.

Vital sign monitoring with continuous pulse oximetry and wireless clinical notification after surgery (the VIGILANCE pilot study)\u2014a randomized controlled pilot trial

BackgroundRespiratory depression is a serious perioperative complication associated with morbidity and mortality. Recently, technology has become available to wirelessly monitor patients on regular surgical wards with continuous pulse oximetry and wireless clinician notification with alarms. When a patient’s SpO2 falls below a set threshold, the clinician is notified via a pager and may intervene earlier to prevent further clinical deterioration. To date, the technology has not been evaluated with a randomized controlled trial (RCT).MethodsWe designed a parallel-group unblinded pilot RCT of a wireless monitoring system on two surgical wards in an academic teaching hospital. Postsurgical patients with an anticipated length of stay of at least 1 day were included and randomized to standard care or standard care plus wireless respiratory monitoring for up to a 72-h period. The primary outcomes were feasibility outcomes: average patients recruited per week and tolerability of the system by patients. Secondary outcomes included (1) respiratory events (naloxone administration for respiratory depression, ICU transfers, and cardiac arrest team activation) and (2) system alarm types and details. The analysis of the outcomes was based on descriptive statistics and estimates reported using point (95% confidence intervals). Criteria for success of feasibility were recruitment of an average of 15 patients/week and 90% of the patients tolerating the system.ResultsThe pilot trial enrolled 250 of the 335 patients screened for eligibility, with 126 and 124 patients entering the standard monitoring and wireless groups, respectively. Baseline demographics were similar between groups, except for slightly more women in the wireless group. Average patient recruitment per week was 14 95% CI [12, 16] patients. The wireless monitoring was quite tolerable with 86.6% (95% CI 78.2–92.7%) of patients completing the full course, and there were no other adverse events directly attributable to the monitoring. With regard to secondary outcomes, the respiratory event rate was low with only 1 event in the wireless group and none in the control group. The average number of alarms per week was 4.0 (95% CI, 1.6–6.4).ConclusionsThis pilot study demonstrated adequate patient recruitment and high tolerability of the wireless monitoring system. A full RCT that is powered to detect patient important outcomes such as respiratory depression is now underway.Trial registrationClinicalTrials.gov, Registration number NCT02907255, registered 7 September 2016—retrospectively registered.

The development and pilot testing of an adolescent bullying intervention in Indonesia – the ROOTS Indonesia program

ABSTRACTBullying has been described as one of the most tractable risk factors for poor mental health and educational outcomes, yet there is a lack of evidence-based interventions for use in low and middle-income settings. We aimed to develop and assess the feasibility of an adolescent-led school intervention for reducing bullying among adolescents in Indonesian secondary schools. The intervention was developed in iterative stages: identifying promising interventions for the local context; formative participatory action research to contextualize proposed content and delivery; and finally two pilot studies to assess feasibility and acceptability in South Sulawesi and Central Java. The resulting intervention combines two key elements: 1) a student-driven design to influence students pro-social norms and behavior, and 2) a teacher-training component designed to enhance teacher’s knowledge and self-efficacy for using positive discipline practices. In the first pilot study, we collected data from 2,075 students in a waitlist-controlled trial in four schools in South Sulawesi. The pilot study demonstrated good feasibility and acceptability of the intervention. We found reductions in bullying victimization and perpetration when using the Forms of Bullying Scale. In the second pilot study, we conducted a randomised waitlist controlled trial in eight schools in Central Java, involving a total of 5,517 students. The feasibility and acceptability were good. The quantitative findings were more mixed, with bullying perpetration and victimization increasing in both control and intervention schools. We have designed an intervention that is acceptable to various stakeholders, feasible to deliver, is designed to be scalable, and has a clear theory of change in which targeting adolescent social norms drives behavioral change. We observed mixed findings across different sites, indicating that further adaptation to context may be needed. A full-randomized controlled trial is required to examine effectiveness and cost-effectiveness of the program.

A comparison of emotion-focused therapy and cognitive-behavioural therapy in the treatment of generalised anxiety disorder: study protocol for a randomised controlled trial

BackgroundGeneralised anxiety disorder (GAD) is a chronic and debilitating condition characterised by high co-morbidity. Alongside pharmacological treatment, cognitive behavioural therapy (CBT) is an established psychological therapy for GAD. Its effectiveness is limited, however, with only an estimated 50% of clients presenting in the non-clinical range after a course of treatment. Furthermore, not all clients prefer CBT as a psychological therapy. Recently, emotion-focused therapy (EFT) was developed for GAD and was tested in an open trial with promising results.Methods/designThe present research project is a feasibility testing randomised controlled trial (RCT) that compares the efficacy of EFT with an established treatment for GAD, CBT. Sixty clients presenting in a primary care psychology/counselling service will be randomly assigned to one of two conditions: EFT or CBT. Outcomes will be assessed using several measures (Generalised Anxiety Disorder-7, Generalised Anxiety Disorder Severity Scale, Patient Health Questionnaire-9, and Clinical Outcome in Routine Evaluation – Outcome Measure). Clients will be assessed prior to and at the end of therapy, as well as at 6-month follow-up. On the basis of findings from the initial open EFT trial with regard to the optimal length of therapy, it is proposed that therapy last between 16 and 20 sessions.DiscussionThis study aims to test the feasibility of a full comparison RCT. It will test subject recruitment, therapist adherence to manualised treatment, and client retention rates. It will also provide estimates of comparative outcomes that can inform power calculations for a definitive trial.Trial registrationISRCTN Registry, ISRCTN52689081. Registered on 24 October 2017.

Self-Control, Plan Quality, and Digital Delivery of Action Planning for Condom and Contraceptive Pill Use of 14-24-Year-Olds: Findings from a Clinic-Based Online Pilot Randomised Controlled Trial.

Inconsistent use of the contraceptive pill and condoms contributes significantly to poor sexual health outcomes for young people. There is evidence that action planning interventions may improve pill and condom use, but this approach is not systematically used in sexual healthcare. This study is the first to assess acceptability and feasibility of evaluating a digital intervention to support action plan formation for three sexual health behaviours with clinic attendees. It also considered the role of trait self-control and whether the intervention supported production of quality plans. Eighty-eight integrated sexual health clinic attendees aged 14-24 years (M = 20.27 years) were recruited to a pilot randomised controlled trial (RCT). Of these, 67 also completed three-month follow-up. Measures included self-reported contraceptive or condom "mishaps", theory of planned behaviour variables, and a measure of self-control. Descriptive analyses supported study acceptability and feasibility. The intervention supported pill and condom users to produce quality plans, though potential improvements were identified. Bivariate correlations suggested that high levels of trait self-control may negatively influence plan quality. Data suggest that the intervention may reduce pill or condom "mishaps". A future full RCT is likely feasible and brief digital action planning interventions may usefully be incorporated within sexual healthcare.

Partial ablation versus radical prostatectomy in intermediate-risk prostate cancer: the PART feasibility RCT.

Prostate cancer (PCa) is the most common cancer in men in the UK. Patients with intermediate-risk, clinically localised disease are offered radical treatments such as surgery or radiotherapy, which can result in severe side effects. A number of alternative partial ablation (PA) technologies that may reduce treatment burden are available; however the comparative effectiveness of these techniques has never been evaluated in a randomised controlled trial (RCT). To assess the feasibility of a RCT of PA using high-intensity focused ultrasound (HIFU) versus radical prostatectomy (RP) for intermediate-risk PCa and to test and optimise methods of data capture. We carried out a prospective, multicentre, open-label feasibility study to inform the design and conduct of a future RCT, involving a QuinteT Recruitment Intervention (QRI) to understand barriers to participation. Five NHS hospitals in England. Men with unilateral, intermediate-risk, clinically localised PCa. Radical prostatectomy compared with HIFU. The randomisation of 80 men. Findings of the QRI and assessment of data capture methods. Eighty-seven patients consented to participate by 31 March 2017 and 82 men were randomised by 4 May 2017 (41 men to the RP arm and 41 to the HIFU arm). The QRI was conducted in two iterative phases: phase I identified a number of barriers to recruitment, including organisational challenges, lack of recruiter equipoise and difficulties communicating with patients about the study, and phase II comprised the development and delivery of tailored strategies to optimise recruitment, including group training, individual feedback and 'tips' documents. At the time of data extraction, on 10 October 2017, treatment data were available for 71 patients. Patient characteristics were similar at baseline and the rate of return of all clinical case report forms (CRFs) was 95%; the return rate of the patient-reported outcome measures (PROMs) questionnaire pack was 90.5%. Centres with specific long-standing expertise in offering HIFU as a routine NHS treatment option had lower recruitment rates (Basingstoke and Southampton) - with University College Hospital failing to enrol any participants - than centres offering HIFU in the trial context only. Randomisation of men to a RCT comparing PA with radical treatments of the prostate is feasible. The QRI provided insights into the complexities of recruiting to this surgical trial and has highlighted a number of key lessons that are likely to be important if the study progresses to a main trial. A full RCT comparing clinical effectiveness, cost-effectiveness and quality-of-life outcomes between radical treatments and PA is now warranted. Men recruited to the feasibility study will be followed up for 36 months in accordance with the protocol. We will design a full RCT, taking into account the lessons learnt from this study. CRFs will be streamlined, and the length and frequency of PROMs and resource use diaries will be reviewed to reduce the burden on patients and research nurses and to optimise data completeness. Current Controlled Trials ISRCTN99760303. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 52. See the NIHR Journals Library website for further project information.

Does early intervention improve outcomes in the physiotherapy management of lumbar radicular syndrome? Results of the POLAR pilot randomised controlled trial

ObjectiveTo investigate the feasibility of undertaking a definitive randomised controlled trial (RCT).SettingThis was a pilot, pragmatic superiority RCT with a qualitative element, recruiting from 14 general practitioner (GP) practices in...

No increase in 6-week treatment effect of Mechanical Diagnosis and Therapy with the use of the LUMOback in people with non-acute non-specific low back pain and a directional preference of extension: a pilot randomized controlled trial

ObjectivesTo pilot the methods for a randomized controlled trial (RCT) to investigate whether the treatment effect of Mechanical Diagnosis and Therapy (MDT) is enhanced with the LUMOback. DesignAssessor blinded RCT with 3 and 6-week follow-ups. SettingAn outpatient clinic. ParticipantsPrimary eligibility criteria were: a directional preference of lumbar extension, ≥18years of age, and non-specific low back pain lasting for ≥1month. InterventionsThe MDT group undertook extension exercises (10reps/3hour) and postural correction using a lumbar roll at home. The MDT+LUMOback group also wore the LUMOback daily, providing a vibration alert in a slouched posture. Main outcome measuresThe Global Rating of Change Scale (GRCS) (0–6), recruitment rate per month, treatment sessions, compliance rate of wearing the LUMOback, participants’ adherence with treatment, dropout rate and the stage of the MDT program at six weeks. ResultsTwenty-two participants were included for 20 months (a recruitment rate of 1.1 patient/month). Dropout rate was 9%. The mean (SD) of the GRCS of the MDT and MDT+LUMOback groups were 4.7 (0.8) and 4.7 (0.5) at the 3-week follow-up and were both 4.9 (0.5) at the 6-week follow-up. The patients undertook a mean of 6.7 sessions for six weeks and exercises with mean of 3.7set/day in each group. The mean compliance rate of wearing the LUMOback was 88%. Nobody was discharged from the intervention with full recovery within six weeks. ConclusionsData indicated a promising method for the full RCT, but a rationale for the full RCT was not justified.Clinical Trial Registration number: UMIN000018380.

Introducing supported self-management for depression to primary care in Vietnam: A feasibility study in preparation for a randomized controlled trial.

Although depression is a major contributor to the global burden of disease, services remain scarce in many low- and middle-income countries. In Vietnam, depression services are limited, and the government has recently prioritized primary care and community-based service integration. We conducted a pilot study in 2 districts of Hanoi to test the feasibility of (a) introducing a supported self-management (SSM) intervention for adult depression in primary care in Vietnam, and (b) conducting a randomized controlled trial (RCT) to test the effectiveness of the intervention. We conducted focus groups with providers (n = 16) and community members (n = 32) to assess the appropriateness of an Antidepressant Skills Workbook for use in Vietnam. We trained providers (n = 23) to screen patients using the Self-Reporting Questionnaire-20 (SRQ-20) depression scale and to deliver SSM for a 2-month period. A total of 71 patients were eligible to participate in the study, with depression (SRQ-20) and disability (World Health Organization Disability Assessment Schedule 2.0) scores assessed at baseline and 1 and 2 months. Study results demonstrate the feasibility of conducting a full RCT in Vietnam and suggest that SSM is an appropriate care model for the Vietnamese context. There was a statistically significant decrease in depression symptoms on the SRQ-20 and in functional disability in all domains for the World Health Organization Disability Assessment Schedule 2.). Feasibility study results suggested that a full RCT was warranted. An unanticipated outcome of the study was the uptake of the model by the Ministry of Labor, Invalids, and Social Affairs in 2 additional provinces. (PsycINFO Database Record

The treatment of booking gestational diabetes mellitus (TOBOGM) pilot randomised controlled trial

BackgroundWe piloted a randomised controlled trial (RCT) comparing pregnancy outcomes among women with booking gestational diabetes (GDM) receiving immediate or deferred treatment.MethodsConsecutive, consenting women < 20 weeks gestation, with GDM risk factors attending the hospital book-in clinic, completed an oral glucose tolerance test (OGTT). Clinicians were blinded to OGTT results. Women fulfilling World Health Organisation GDM criteria were randomised to either clinic referral /ongoing treatment (Treated Group n = 11), or no treatment (No Treatment Group n = 10). Women without ‘Booking GDM’ (‘Decoys’ n = 58) and those in the No Treatment Group had a repeat OGTT at 24–28 weeks (with GDM treated if diagnosed). Midwives and mothers were asked to complete surveys and attend focus groups before and after the study respectively regarding their experiences and expectations of the study protocol.ResultsSufficient women completed each step of the RCT. Gestation at OGTT was late at 18 ± 2 weeks with Treated and No Treatment groups largely similar. At 24–28 weeks gestation, GDM was present in 8/9 (89%) in the No Treatment group and 11/56 (20%) Decoys. NICU admission was highest in the Treated group (36% vs 0% p = 0.043), largely due to small for gestational age, and Large for Gestational Age babies greatest in the No Treatment group (0% vs 33% p = 0.030).ConclusionAn RCT deferring ‘Booking GDM’ treatment is feasible. Most women with untreated ‘Booking GDM’ in mid 2nd trimester had GDM at 24–28 weeks. Early treatment may have both benefits and harms. A full RCT is needed.Trial registrationAustralia New Zealand Clinical Trials Registry ACTRN12615000974505. Registered 17th May 2015; URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=369100&isReview=true Retrospectively Registered.

CONTRACT Study - CONservative TReatment of Appendicitis in Children (feasibility): study protocol for a randomised controlled Trial

BackgroundCurrently, the routine treatment for acute appendicitis in the United Kingdom is an appendicectomy. However, there is increasing scientific interest and research into non-operative treatment of appendicitis in adults and children. While a number of studies have investigated non-operative treatment of appendicitis in adults, this research cannot be applied to the paediatric population. Ultimately, we aim to perform a UK-based multicentre randomised controlled trial (RCT) to test the clinical and cost effectiveness of non-operative treatment of acute uncomplicated appendicitis in children, as compared with appendicectomy. First, we will undertake a feasibility study to assess the feasibility of performing such a trial.Methods/designThe study involves a feasibility RCT with a nested qualitative research to optimise recruitment as well as a health economic substudy. Children (aged 4–15 years inclusive) diagnosed with acute uncomplicated appendicitis that would normally be treated with an appendicectomy are eligible for the RCT. Exclusion criteria include clinical/radiological suspicion of perforated appendicitis, appendix mass or previous non-operative treatment of appendicitis. Participants will be randomised into one of two arms. Participants in the intervention arm are treated with antibiotics and regular clinical assessment to ensure clinical improvement. Participants in the control arm will receive appendicectomy. Randomisation will be minimised by age, sex, duration of symptoms and centre. Children and families who are approached for the RCT will be invited to participate in the embedded qualitative substudy, which includes recording of recruitment consultants and subsequent interviews with participants and non-participants and their families and recruiters. Analyses of these will inform interventions to optimise recruitment. The main study outcomes include recruitment rate (primary outcome), identification of strategies to optimise recruitment, performance of trial treatment pathways, clinical outcomes and safety of non-operative treatment. We have involved children, young people and parents in study design and delivery.DiscussionIn this study we will explore the feasibility of performing a full efficacy RCT comparing non-operative treatment with appendicectomy in children with acute uncomplicated appendicitis. Factors determining success of the present study include recruitment rate, safety of non-operative treatment and adequate interest in the future RCT. Ultimately this feasibility study will form the foundation of the main RCT and reinforce its design.Trial registrationISRCTN15830435. Registered on 8 February 2017.

Memory-focused cognitive therapy for cocaine use disorder: Rationale, design and protocol for an external pilot randomised controlled trial.

IntroductionCocaine use disorder (CUD) is a debilitating condition characterised by maladaptive cocaine-related memories and impaired cognitive and behavioural control. There are no evidence-supported pharmacotherapies and only weakly effective psychological interventions specific for CUD. Our novel Memory-focused Cognitive Therapy (MFCT) aims to modify cocaine-related memories to reduce craving and drug use.MethodsThis is a single-centre (outpatient), 15-week, two-arm, pilot randomised controlled trial (RCT) to address feasibility, safety, quality and preliminary efficacy. Thirty participants (adults ≥18 years; current CUD) will receive ongoing standard care (treatment-as-usual [TAU]) during the study and will be randomised (1:1) to a control or intervention group. The control group will receive 3 × 90min CUD cognitive case conceptualisation assessments and 2 × 30min cocaine-related cue-induction procedures (in vivo presentation of images and objects). Experimental group participants will receive 3 × 90min CUD cognitive case conceptualisation assessments; 2 × 30min cue-induction procedures; and individual MFCT (5 × 120min; daily for 1 week; with 3 relapse prevention follow-ups over 3-months). All study participants will complete research follow-ups at 1-week, 1-month and 3-months. The experimental and control groups will be compared on the mean score on the frequency version of the Craving Experience Questionnaire at 1-month (primary outcome measure). Secondary outcomes include: percentage of days abstinent and longest period of continuous abstinence from cocaine (past 28-days at 1-month follow-up); urine drug screen and CUD diagnosis (DSM-5).ConclusionsWe will conduct a full external pilot RCT of a novel, MFCT for CUD. The findings will inform the case, and necessary modifications, for a substantive study.

The over-representation of significant p values in abstracts compared to corresponding full texts: A systematic review of surgical randomized trials.

Backgrounds are often the only read summaries of research findings, and it is essential that they accurately represent of the contents of the full text of the randomised control trial (RCT). We investigated whether outcomes in surgical trials were selectively reported in abstracts based on their statistical significance.ObjectiveTo compare the proportion of significant p-values reported in abstracts to their corresponding full texts in surgical RCTs.MethodA Meta-analysis of 350 full text RCTs conducted on humans that compared a surgical intervention to any other intervention. An electronic search of MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials (CENTRAL) was conducted. All outcomes were extracted from the abstract and the full text. Frequency histograms were used to plot the distribution of numerically reported p-values across the statistical significance spectrum. For each RCT, a 2 × 2 table was populated with that trial's outcomes and whether the outcome was statistically significant (p < 0.05). From each 2 × 2 table, an odds ratio (OR) was calculated describing the association between statistical significance, and reporting in the abstract. ORs were pooled in random effects meta-analysis for an overall estimate of the association.ResultsA total of 8258 reported outcomes were included. Outcomes reported in a surgical RCT abstract had three times the odds of being significant when compared to the corresponding full text (OR = 3.0, 95% confidence interval 2.5–3.6, p < 0.001). This finding was consistent and not subject to heterogeneity (I2 = 0%). Both histograms demonstrated a large drop in the frequency of reported p values between 0.04 and 0.05, and after the 0.06 thresholds.ConclusionsData presented in abstracts is biased to statistically significant outcomes. Clinicians and policy makers should do not rely solely on information presented in abstracts for their decision-making.

Tablet computers versus optical aids to support education and learning in children and young people with low vision: protocol for a pilot randomised controlled trial, CREATE (Children Reading with Electronic Assistance To Educate)

IntroductionLow vision and blindness adversely affect education and independence of children and young people. New ‘assistive’ technologies such as tablet computers can display text in enlarged font, read text out...

Modifying Alcohol Consumption to Reduce Obesity (MACRO): development and feasibility trial of a complex community-based intervention for men.

Obese men who consume alcohol are at a greatly increased risk of liver disease; those who drink > 14 units of alcohol per week have a 19-fold increased risk of dying from liver disease. To develop an intervention to reduce alcohol consumption in obese men and to assess the feasibility of a randomised controlled trial (RCT) to investigate its effectiveness. The intervention was developed using formative research, public involvement and behaviour change theory. It was organised in two phases, comprising a face-to-face session with trained laypeople (study co-ordinators) followed by a series of text messages. Participants explored how alcohol consumption contributed to weight gain, both through direct calorie consumption and through its effect on increasing food consumption, particularly of high-calorie foodstuffs. Men were encouraged to set goals to reduce their alcohol consumption and to make specific plans to do so. The comparator group received an active control in the form of a conventional alcohol brief intervention. Randomisation was carried out using the secure remote web-based system provided by the Tayside Clinical Trials Unit. Randomisation was stratified by the recruitment method and restricted using block sizes of randomly varying lengths. Members of the public were involved in the development of all study methods. Men were recruited from the community, from primary care registers and by time-space sampling (TSS). The intervention was delivered in community settings such as the participant's home, community centres and libraries. Men aged 35-64 years who had a body mass index (BMI) of > 30 kg/m2 and who drank > 21 units of alcohol per week. The screening methods successfully identified participants meeting the entry criteria. Trial recruitment was successful, with 69 men (36 from 419 approached in primary care, and 33 from 470 approached via TSS) recruited and randomised in 3 months. Of the 69 men randomised, 35 were allocated to the intervention group and 34 to the control group. The analysis was conducted on 31 participants from the intervention group and 30 from the control group. The participants covered a wide range of ages and socioeconomic statuses. The average alcohol consumption of the men recruited was 47.2 units per week, more than twice that of the entry criterion (> 21 units per week). Most (78%) engaged in binge drinking (> 8 units in a session) at least weekly. Almost all (95%) exceeded the threshold for a 19-fold increase in the risk of dying from liver disease (BMI of > 30 kg/m2 and > 14 units of alcohol per week). Despite this, they believed that they were at low risk of harm from alcohol, possibly because they seldom suffered acute harms (e.g. hangovers) and made few visits to a general practitioner or hospital. The intervention was delivered with high fidelity. A high follow-up rate was achieved (98%) and the outcomes for the full RCT were measured. A process evaluation showed that participants engaged with the main components of the intervention. The acceptability of the study methods was high. This feasibility study developed a novel intervention and evaluated all of the stages of a RCT that would test the effectiveness of the intervention. The main stages of a trial were completed successfully: recruitment, randomisation, intervention delivery, follow-up and measurement of study outcomes. Most of the men recruited drank very heavily and were also obese. This places them at a very high risk of liver disease, making them a priority for intervention. A RCT to test the effectiveness and cost-effectiveness of the intervention. Current Controlled Trials ISRCTN55309164. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 19. See the NIHR Journals Library website for further project information.