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1.  ‘Putting Life in Years’ (PLINY) telephone friendship groups research study: pilot randomised controlled trial 
Trials  2014;15:141.
Loneliness in older people is associated with poor health-related quality of life (HRQoL). We undertook a parallel-group randomised controlled trial to evaluate the effectiveness and cost-effectiveness of telephone befriending for the maintenance of HRQoL in older people. An internal pilot tested the feasibility of the trial and intervention.
Participants aged >74 years, with good cognitive function, living independently in one UK city were recruited through general practices and other sources, then randomised to: (1) 6 weeks of short one-to-one telephone calls, followed by 12 weeks of group telephone calls with up to six participants, led by a trained volunteer facilitator; or (2) a control group. The main trial required the recruitment of 248 participants in a 1-year accrual window, of whom 124 were to receive telephone befriending. The pilot specified three success criteria which had to be met in order to progress the main trial to completion: recruitment of 68 participants in 95 days; retention of 80% participants at 6 months; successful delivery of telephone befriending by local franchise of national charity. The primary clinical outcome was the Short Form (36) Health Instrument (SF-36) Mental Health (MH) dimension score collected by telephone 6 months following randomisation.
We informed 9,579 older people about the study. Seventy consenting participants were randomised to the pilot in 95 days, with 56 (80%) providing valid primary outcome data (26 intervention, 30 control). Twenty-four participants randomly allocated to the research arm actually received telephone befriending due to poor recruitment and retention of volunteer facilitators. The trial was closed early as a result. The mean 6-month SF-36 MH scores were 78 (SD 18) and 71 (SD 21) for the intervention and control groups, respectively (mean difference, 7; 95% CI, -3 to 16).
Recruitment and retention of participants to a definitive trial with a recruitment window of 1 year is feasible. For the voluntary sector to recruit sufficient volunteers to match demand for telephone befriending created by trial recruitment would require the study to be run in more than one major population centre, and/or involve dedicated management of volunteers.
Trial registration
PMCID: PMC4022155  PMID: 24758530
2.  Cognitive behavioural therapy for the treatment of depression in people with multiple sclerosis: a systematic review and meta-analysis 
BMC Psychiatry  2014;14:5.
Depression is a common symptom in people with multiple sclerosis. We systematically reviewed published controlled trials on the effectiveness of cognitive behavioural therapy (CBT) for the treatment of depression in people with multiple sclerosis.
Publications were identified using MEDLINE, PsycINFO and the Cochrane Central Register of Controlled Trials to June/July 2013. We combined thesaurus and free-text terms which were synonyms of the concepts multiple sclerosis, depression and cognitive behavioural therapy. We included published controlled trials which compared individual, group CBT, conducted face-to-face or remotely, to no CBT. Two reviewers extracted data to calculate standardized mean differences (SMD) for self-reported symptoms of depression and weighted mean differences (WMD) for the Multiple Sclerosis Impact Scale (MSIS-29), with 95% Confidence Intervals (CIs). We investigated statistical heterogeneity using I2.
Seven eligible studies (n = 433) were identified, which evaluated the effect on depression of CBT delivered individually (3 studies), in a group (3 studies) and by computer (1 study). The summary effect (SMD -0.61, 95% CI -0.96 to -0.26, p=0.0006) was reduced (SMD -0.46, 95% CI -0.75 to -0.17, p=0.002) when an outlying study was removed in a sensitivity analysis to examine statistical heterogeneity. Three studies (n=213) observed a direction of effect using the MSIS-29 which was not statistically significant (WMD -4.36, 95% CI -9.33 to 0.62, p=0.09). There was no between-subgroup heterogeneity (I2=0).
CBT can be an effective treatment for depression in MS. Further research should explore optimal durations and modalities of treatment for patients with different characteristics.
PMCID: PMC3890565  PMID: 24406031
Cognitive-behavioural therapy; Depression; Multiple sclerosis; Quality of life; Systematic review
4.  Lifestyle Matters for maintenance of health and wellbeing in people aged 65 years and over: study protocol for a randomised controlled trial 
Trials  2013;14:302.
Healthy, active ageing is strongly associated with good mental wellbeing which in turn helps to prevent mental illness. However, more investment has been made into research into interventions to prevent mental illness than into those designed to improve mental wellbeing. This applied research programme will provide high quality evidence for an intervention designed to improve and sustain mental wellbeing in older adults.
This study was a multi-centre, pragmatic, two-arm, parallel group, individually randomised controlled trial to determine the population benefit of an occupational therapy based intervention for community living people aged 65 years or older. Participants (n = 268) will be identified in one city in the North of England and in North Wales through GP mail-outs, signposting by local authority, primary care staff and voluntary sector organisations and through community engagement. Participants will be randomised to one of two treatment arms: an intervention (Lifestyle Matters programme); or control (routine access to health and social care). All participants will be assessed at baseline, 6 and 24 months post-randomisation. The primary outcome, which is a person reported outcome, is the SF-36 Mental Health dimension at six months post randomisation. Secondary outcome measures have been selected to measure psychosocial, physical and mental health outcomes. They include other dimensions of the SF36, EQ-5D-3L, Brief Resilience Scale, General Perceived Self Efficacy Scale, PHQ-9, de Jong Gierveld Loneliness Scale, Health and Social Care Resource Use and the wellbeing question of the Integrated Household Survey 2011. A cost effectiveness analysis will investigate the incremental cost per Quality Adjusted Life Years (QALYs) of the Lifestyle Matters intervention compared with treatment as usual.
The questions being posed through this research are important given the increasing numbers of older people, pressure on the public purse and the associated need to support good health in the extended lifespan. The proposed trial will determine the clinical and cost effectiveness of the intervention delivered in a UK context. The results will support commissioners and providers with decisions about implementation.
Trial registration
Current Controlled Trials ISRCTN67209155
PMCID: PMC3849528  PMID: 24053549
Lifestyle Matters; Psychosocial Intervention; Prevention; Older adults; Quality of life; Wellbeing; Mental health; Mental wellbeing
5.  The Effect of Complex Interventions on Depression and Anxiety in Chronic Obstructive Pulmonary Disease: Systematic Review and Meta-Analysis 
PLoS ONE  2013;8(4):e60532.
Depression and anxiety are very common in people with chronic obstructive pulmonary disease (COPD) and are associated with excess morbidity and mortality. Patients prefer non-drug treatments and clinical guidelines promote non-pharmacological interventions as first line therapy for depression and anxiety in people with long term conditions. However the comparative effectiveness of psychological and lifestyle interventions among COPD patients is not known. We assessed whether complex psychological and/or lifestyle interventions are effective in reducing symptoms of anxiety and depression in patients with COPD. We then determined what types of psychological and lifestyle interventions are most effective.
Methods and Findings
Systematic review of randomised controlled trials of psychological and/or lifestyle interventions for adults with COPD that measured symptoms of depression and/or anxiety. CENTRAL, Medline, Embase, PsychINFO, CINAHL, ISI Web of Science and Scopus were searched up to April 2012. Meta-analyses using random effects models were undertaken to estimate the average effect of interventions on depression and anxiety. Thirty independent comparisons from 29 randomised controlled trials (n = 2063) were included in the meta-analysis. Overall, psychological and/or lifestyle interventions were associated with small reductions in symptoms of depression (standardised mean difference −0.28, 95% confidence interval −0.41 to −0.14) and anxiety (standardised mean difference −0.23, 95% confidence interval −0.38 to −0.09). Multi-component exercise training was the only intervention subgroup associated with significant treatment effects for depression (standardised mean difference −0.47, 95% confidence interval −0.66 to −0.28), and for anxiety (standardised mean difference −0.45, 95% confidence interval −0.71 to −0.18).
Complex psychological and/or lifestyle interventions that include an exercise component significantly improve symptoms of depression and anxiety in people with COPD. Furthermore, multi-component exercise training effectively reduces symptoms of anxiety and depression in all people with COPD regardless of severity of depression or anxiety, highlighting the importance of promoting physical activity in this population.
PMCID: PMC3621386  PMID: 23585837
6.  The HubBLe trial: haemorrhoidal artery ligation (HAL) versus rubber band ligation (RBL) for haemorrhoids 
BMC Gastroenterology  2012;12:153.
Haemorrhoids (piles) are a very common condition seen in surgical clinics. After exclusion of more sinister causes of haemorrhoidal symptoms (rectal bleeding, perianal irritation and prolapse), the best option for treatment depends upon persistence and severity of the symptoms. Minor symptoms often respond to conservative treatment such as dietary fibre and reassurance. For more severe symptoms treatment such as rubber band ligation may be therapeutic and is a very commonly performed procedure in the surgical outpatient setting. Surgery is usually reserved for those who have more severe symptoms, as well as those who do not respond to non-operative therapy; surgical techniques include haemorrhoidectomy and haemorrhoidopexy. More recently, haemorrhoidal artery ligation has been introduced as a minimally invasive, non destructive surgical option.
There are substantial data in the literature concerning efficacy and safety of 'rubber band ligation including multiple comparisons with other interventions, though there are no studies comparing it to haemorrhoidal artery ligation. A recent overview has been carried out by the National Institute for Health and Clinical Excellence which concludes that current evidence shows haemorrhoidal artery ligation to be a safe alternative to haemorrhoidectomy and haemorrhoidopexy though it also highlights the lack of good quality data as evidence for the advantages of the technique.
The aim of this study is to establish the clinical effectiveness and cost effectiveness of haemorrhoidal artery ligation compared with conventional rubber band ligation in the treatment of people with symptomatic second or third degree (Grade II or Grade III) haemorrhoids.
Design: A multi-centre, parallel group randomised controlled trial.
Outcomes: The primary outcome is patient-reported symptom recurrence twelve months following the intervention. Secondary outcome measures relate to symptoms, complications, health resource use, health related quality of life and cost effectiveness following the intervention.
Participants: 350 patients with grade II or grade III haemorrhoids will be recruited in surgical departments in up to 14 NHS hospitals.
Randomisation: A multi-centre, parallel group randomised controlled trial. Block randomisation by centre will be used, with 175 participants randomised to each group.
The results of the research will help inform future practice for the treatment of grade II and III haemorrhoids.
Trial Registration
PMCID: PMC3503770  PMID: 23098097
Haemorrhoids; Rubber band ligation; Haemorrhoidal artery ligation; Surgical randomised controlled trial
7.  Computerised cognitive behavioural therapy for the treatment of depression in people with multiple sclerosis: external pilot trial 
Trials  2011;12:259.
People with multiple sclerosis (MS) are at high risk of depression. We undertook a pilot trial of computerised cognitive behavioural therapy (CCBT) for the treatment of depression in people with MS to test the feasibility of undertaking a full trial.
Participants with a diagnosis of MS and clinical levels of depression were recruited through out-patient clinics and postal screening questionnaires at two UK centres and randomised to CCBT or usual care. Clinical outcomes included the Beck Depression Inventory (BDI-II) and Multiple Sclerosis Impact Scale (MSIS-29) at baseline, 8 and 21 weeks. Feasibility outcomes included: recruitment rate; reasons for refusal, withdrawal and dropout; feasibility and acceptability of the proposed outcome measures; sample size estimation and variation in and preferences for service delivery.
Twenty-four participants were recruited. The recruitment rate, calculated as the proportion of those invited to fill in a screening questionnaire who were consented into the trial, was 4.1%. Recruitment through out-patient clinics was somewhat slower than through screening questionnaire mail-out but the overall recruitment yield was similar. Of the 12 patients in the CCBT arm, 9 (75%) completed at least four, and 6 completed all 8 CCBT sessions. For completers, the median time (IQR) to complete all eight CCBT sessions was 15 (13 to 20) weeks. Participants expressed concern about the face validity of the Beck Depression Inventory II for the measurement of self-reported depression in people with MS. The MSIS-29 was the patient-reported outcome measure which participants felt best reflected their concerns. The estimated sample size for a full trial is between 180 and 390 participants. NHS partners were not delivering CCBT in community facilities and participants preferred to access CCBT at home, with no one expressing a preference for use of CCBT in an alternative location.
A definitive trial, with a recruitment window of one year, would require the participation of around 13 MS centres. This number of centres could be reduced by expanding the eligibility criteria to include either other neurological conditions or people with more severe depression. The MSIS-29 should be used as a patient-important outcome measurement.
Trial registration
PMCID: PMC3272061  PMID: 22168507
8.  "Booster" interventions to sustain increases in physical activity in middle-aged adults in deprived urban neighbourhoods: internal pilot and feasibility study 
BMC Public Health  2011;11:129.
Systematic reviews have identified a range of brief interventions which increase physical activity in previously sedentary people. A randomised controlled trial is needed to assess whether providing motivational interviewing, three months after giving initial advice, sustains physical activity levels in those who recently became physically active. This paper reports the results of an internal pilot study designed to test the feasibility of the study in terms of recruitment, per protocol delivery of the intervention and retention at three months.
Participants were: aged 40-64 years; resident in deprived areas of Sheffield, UK; and, had recently become physically active as a result of using a brief intervention following an invitation from a mass mailout. Interventions: Motivational Interviewing 'boosters' aimed at sustaining change in physical activity status delivered face-to-face or over the telephone compared with no further intervention. Outcomes of the feasibility study: recruitment of 60 participants from mailout of 3,300; retention of 45 participants with 3-month follow-up accelerometry measurements; 70% of those randomised to boosters receiving intervention per protocol. Sample size and power were recalculated using the accelerometry data collected.
Forty-seven participants were randomised (78% of the feasibility target); 37 participants were retained at three months, 29 with at least four days of accelerometry data (64% of the feasibility target); 79% of those allocated boosters received them per protocol (surpassing the feasibility target). The proposed sample size of 600 was confirmed as appropriate and power is expected to be sufficient to detect a difference between groups.
The main study will continue with the original recruitment target of 600 participants but to ensure feasibility, it is necessary to increase recruitment and improve the numbers of those followed-up who have evaluable data. Strategies will include increasing the number of initial invitations sent out and improving the training of research assistants and participants in the positioning of the accelerometer.
Trial Registration
ISRCTN: ISRCTN56495859, ClinicalTrials (NCT): NCT00836459
PMCID: PMC3050753  PMID: 21345182
9.  A randomised controlled trial and cost-effectiveness evaluation of "booster" interventions to sustain increases in physical activity in middle-aged adults in deprived urban neighbourhoods 
BMC Public Health  2010;10:3.
Systematic reviews have identified a range of brief interventions which increase physical activity in previously sedentary people. There is an absence of evidence about whether follow up beyond three months can maintain long term physical activity. This study assesses whether it is worth providing motivational interviews, three months after giving initial advice, to those who have become more active.
Study candidates (n = 1500) will initially be given an interactive DVD and receive two telephone follow ups at monthly intervals checking on receipt and use of the DVD. Only those that have increased their physical activity after three months (n = 600) will be randomised into the study. These participants will receive either a "mini booster" (n = 200), "full booster" (n = 200) or no booster (n = 200). The "mini booster" consists of two telephone calls one month apart to discuss physical activity and maintenance strategies. The "full booster" consists of a face-to-face meeting with the facilitator at the same intervals. The purpose of these booster sessions is to help the individual maintain their increase in physical activity. Differences in physical activity, quality of life and costs associated with the booster interventions, will be measured three and nine months from randomisation. The research will be conducted in 20 of the most deprived neighbourhoods in Sheffield, which have large, ethnically diverse populations, high levels of economic deprivation, low levels of physical activity, poorer health and shorter life expectancy. Participants will be recruited through general practices and community groups, as well as by postal invitation, to ensure the participation of minority ethnic groups and those with lower levels of literacy. Sheffield City Council and Primary Care Trust fund a range of facilities and activities to promote physical activity and variations in access to these between neighbourhoods will make it possible to examine whether the effectiveness of the intervention is modified by access to community facilities. A one-year integrated feasibility study will confirm that recruitment targets are achievable based on a 10% sample.
The choice of study population, study interventions, brief intervention preceding the study, and outcome measure are discussed.
Trial Registration
Current Controlled Trials: ISRCTN56495859; NCT00836459.
PMCID: PMC2819992  PMID: 20047672
10.  Do health technology assessments comply with QUOROM diagram guidance? An empirical study 
The Quality of Reporting of Meta-analyses (QUOROM) statement provides guidance for improving the quality of reporting of systematic reviews and meta-analyses. To make the process of study selection transparent it recommends "a flow diagram providing information about the number of RCTs identified, included, and excluded and the reasons for excluding them". We undertook an empirical study to identify the extent of compliance in the UK Health Technology Assessment (HTA) programme.
We searched Medline to retrieve all systematic reviews of therapeutic interventions in the HTA monograph series published from 2001 to 2005. Two researchers recorded whether each study contained a meta-analysis of controlled trials, whether a QUOROM flow diagram was presented and, if so, whether it expressed the relationship between the number of citations and the number of studies. We used Cohen's kappa to test inter-rater reliability.
87 systematic reviews were retrieved. There was good and excellent inter-rater reliability for, respectively, whether a review contained a meta-analysis and whether each diagram contained a citation-to-study relationship. 49% of systematic reviews used a study selection flow diagram. When only systematic reviews containing a meta-analysis were analysed, compliance was only 32%. Only 20 studies (23% of all systematic reviews; 43% of those having a study selection diagram) had a diagram which expressed the relationship between citations and studies.
Compliance with the recommendations of the QUOROM statement is not universal in systematic reviews or meta-analyses. Flow diagrams make the conduct of study selection transparent only if the relationship between citations and studies is clearly expressed. Reviewers should understand what they are counting: citations, papers, studies and trials are fundamentally different concepts which should not be confused in a diagram.
PMCID: PMC2211304  PMID: 18021461
11.  Ultrasonic locating devices for central venous cannulation: meta-analysis 
BMJ : British Medical Journal  2003;327(7411):361.
Objectives To assess the evidence for the clinical effectiveness of ultrasound guided central venous cannulation.
Data sources 15 electronic bibliographic databases, covering biomedical, science, social science, health economics, and grey literature.
Design Systematic review and meta-analysis of randomised controlled trials.
Populations Patients scheduled for central venous access.
Intervention reviewed Guidance using real time two dimensional ultrasonography or Doppler needles and probes compared with the anatomical landmark method of cannulation.
Data extraction Risk of failed catheter placement (primary outcome), risk of complications from placement, risk of failure on first attempt at placement, number of attempts to successful catheterisation, and time (seconds) to successful catheterisation.
Data synthesis 18 trials (1646 participants) were identified. Compared with the landmark method, real time two dimensional ultrasound guidance for cannulating the internal jugular vein in adults was associated with a significantly lower failure rate both overall (relative risk 0.14, 95% confidence interval 0.06 to 0.33) and on the first attempt (0.59, 0.39 to 0.88). Limited evidence favoured two dimensional ultrasound guidance for subclavian vein and femoral vein procedures in adults (0.14, 0.04 to 0.57 and 0.29, 0.07 to 1.21, respectively). Three studies in infants confirmed a higher success rate with two dimensional ultrasonography for internal jugular procedures (0.15, 0.03 to 0.64). Doppler guided cannulation of the internal jugular vein in adults was more successful than the landmark method (0.39, 0.17 to 0.92), but the landmark method was more successful for subclavian vein procedures (1.48, 1.03 to 2.14). No significant difference was found between these techniques for cannulation of the internal jugular vein in infants. An indirect comparison of relative risks suggested that two dimensional ultrasonography would be more successful than Doppler guidance for subclavian vein procedures in adults (0.09, 0.02 to 0.38).
Conclusions Evidence supports the use of two dimensional ultrasonography for central venous cannulation.
PMCID: PMC175809  PMID: 12919984
12.  SABRE: a multicentre randomised control trial of nebulised hypertonic saline in infants hospitalised with acute bronchiolitis 
Thorax  2014;69(12):1105-1112.
Acute bronchiolitis is the commonest cause for hospitalisation in infancy. Supportive care remains the cornerstone of current management and no other therapy has been shown to influence the course of the disease. It has been suggested that adding nebulised hypertonic saline to usual care may shorten the duration of hospitalisation. To determine whether hypertonic saline does have beneficial effects we undertook an open, multi-centre parallel-group, pragmatic RCT in ten UK hospitals.
Infants admitted to hospital with a clinical diagnosis of acute bronchiolitis and requiring oxygen therapy were randomised to receive usual care alone or nebulised 3% hypertonic saline (HS) administered 6-hourly. Randomisation was within 4 h of admission. The primary outcome was time to being assessed as ‘fit’ for discharge with secondary outcomes including time to discharge, incidence of adverse events together with follow up to 28 days assessing patient centred health related outcomes.
A total of 317 infants were recruited to the study. 158 infants were randomised to HS (141 analysed) and 159 to standard care (149 analysed). There was no difference between the two arms in time to being declared fit for discharge (hazard ratio: 0−95, 95% CI: 0.75−1.20) nor to actual discharge (hazard ratio: 0.97, 95% CI: 0.76−1.23). There was no difference in adverse events. One infant in the HS group developed bradycardia with desaturation.
This study does not support the use of nebulised HS in the treatment of acute bronchiolitis over usual care with minimal handlings. registration number
PMCID: PMC4251206  PMID: 25389139
Paediatric Lung Disaese; Viral infection; Nebuliser therapy

Results 1-12 (12)