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1.  Addressing the evidence to practice gap for complex interventions in primary care: a systematic review of reviews protocol 
BMJ Open  2014;4(6):e005548.
Introduction
Getting the results of research implemented into routine healthcare is often a challenge. The disconnect between the development and implementation of evidence into practice is called the ‘second translational gap’ and is particularly apparent in primary care. To address this gap, we plan to identify, summarise and synthesise currently available evidence by undertaking a systematic review of reviews to: (1) explore barriers and facilitators of implementation of research evidence or complex interventions, and (2) assess the effectiveness of strategies in facilitating implementation of complex interventions in primary care.
Methods and analysis
This is a protocol for a systematic review of reviews. We will search MEDLINE, EMBASE, the Cochrane Library, CINAHL and PsycINFO up until December 2013. We will check reference lists of included studies for further studies. Two authors will independently screen the titles and abstracts identified from the search; any discrepancies will be resolved by discussion and consensus. Full-text papers will be obtained and relevant reviews will be selected against inclusion criteria. Eligible reviews have to be based on predominantly primary care in developed countries and examine either factors to implementation or, the effectiveness of strategies to optimise implementation. Data from eligible reviews will be extracted using standardised data abstraction forms. For barriers and facilitators, data will be synthesised using an interpretative meta-synthesis approach. For implementation strategies, findings will be summarised and described narratively and synthesised using a framework approach. All findings will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.
Ethics and dissemination
Ethical approval is not required. The review findings will inform the work of the design and implementation of future studies and will be of interest to a wide audience including health professionals, researchers, health service or commissioning managers and policymakers.
Trial registration number
Protocol registration number (PROSPERO CRD42014009410).
doi:10.1136/bmjopen-2014-005548
PMCID: PMC4067819  PMID: 24958212
Primary Care; Public Health
2.  A systematic review and meta-synthesis of the impact of low back pain on people’s lives 
Background
Low back pain (LBP) is a common and costly problem that many interpret within a biopsychosocial model. There is renewed concern that core-sets of outcome measures do not capture what is important. To inform debate about the coverage of back pain outcome measure core-sets, and to suggest areas worthy of exploration within healthcare consultations, we have synthesised the qualitative literature on the impact of low back pain on people’s lives.
Methods
Two reviewers searched CINAHL, Embase, PsycINFO, PEDro, and Medline, identifying qualitative studies of people’s experiences of non-specific LBP. Abstracted data were thematic coded and synthesised using a meta-ethnographic, and a meta-narrative approach.
Results
We included 49 papers describing 42 studies. Patients are concerned with engagement in meaningful activities; but they also want to be believed and have their experiences and identity, as someone ‘doing battle’ with pain, validated. Patients seek diagnosis, treatment, and cure, but also reassurance of the absence of pathology. Some struggle to meet social expectations and obligations. When these are achieved, the credibility of their pain/disability claims can be jeopardised. Others withdraw, fearful of disapproval, or unable or unwilling to accommodate social demands. Patients generally seek to regain their pre-pain levels of health, and physical and emotional stability. After time, this can be perceived to become unrealistic and some adjust their expectations accordingly.
Conclusions
The social component of the biopsychosocial model is not well represented in current core-sets of outcome measures. Clinicians should appreciate that the broader impact of low back pain includes social factors; this may be crucial to improving patients’ experiences of health care. Researchers should consider social factors to help develop a portfolio of more relevant outcome measures.
doi:10.1186/1471-2474-15-50
PMCID: PMC3932512  PMID: 24559519
Outcome measurement; Outcome measure development; Low back pain; Qualitative synthesis; Social factors; Population-based interventions
3.  Coping with Persistent Pain, Effectiveness Research into Self-management (COPERS): statistical analysis plan for a randomised controlled trial 
Trials  2014;15:59.
Background
The Coping with Persistent Pain, Effectiveness Research into Self-management (COPERS) trial assessed whether a group-based self-management course is effective in reducing pain-related disability in participants with chronic musculoskeletal pain. This article describes the statistical analysis plan for the COPERS trial.
Methods and design
COPERS was a pragmatic, multicentre, unmasked, parallel group, randomised controlled trial. This article describes (a) the overall analysis principles (including which participants will be included in each analysis, how results will be presented, which covariates will be adjusted for, and how we will account for clustering in the intervention group); (b) the primary and secondary outcomes, and how each outcome will be analysed; (c) sensitivity analyses; (d) subgroup analyses; and (e) adherence-adjusted analyses.
Trial registration
ISRCTN24426731
doi:10.1186/1745-6215-15-59
PMCID: PMC3930300  PMID: 24528484
Statistical analysis plan; Randomised controlled trial; Self-management; Chronic musculoskeletal pain; Complex intervention
8.  Effectiveness of financial incentives to improve adherence to maintenance treatment with antipsychotics: cluster randomised controlled trial 
Objective To test whether offering financial incentives to patients with psychotic disorders is effective in improving adherence to maintenance treatment with antipsychotics.
Design Cluster randomised controlled trial.
Setting Community mental health teams in secondary psychiatric care in the United Kingdom.
Participants Patients with a diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder, who were prescribed long acting antipsychotic (depot) injections but had received 75% or less of the prescribed injections. We randomly allocated 73 teams with a total of 141 patients. Primary outcome data were available for 35 intervention teams with 75 patients (96% of randomised) and for 31 control teams with 56 patients (89% of randomised).
Interventions Participants in the intervention group were offered £15 (€17; $22) for each depot injection over a 12 month period. Participants in the control condition received treatment as usual.
Main outcome measure The primary outcome was the percentage of prescribed depot injections given during the 12 month intervention period.
Results 73 teams with 141 consenting patients were randomised, and outcomes were assessed for 131 patients (93%). Average baseline adherence was 69% in the intervention group and 67% in the control group. During the 12 month trial period adherence was 85% in the intervention group and 71% in the control group. The adjusted effect estimate was 11.5% (95% confidence interval 3.9% to 19.0%, P=0.003). A secondary outcome was an adherence of ≥95%, which was achieved in 28% of the intervention group and 5% of the control group (adjusted odds ratio 8.21, 95% confidence interval 2.00 to 33.67, P=0.003). Although differences in clinician rated clinical improvement between the groups failed to reach statistical significance, patients in the intervention group had more favourable subjective quality of life ratings (β=0.71, 95% confidence interval 0.26 to 1.15, P=0.002). The number of admissions to hospital and adverse events were low in both groups and did not show substantial differences.
Conclusion Offering modest financial incentives to patients with psychotic disorders is an effective method for improving adherence to maintenance treatment with antipsychotics.
Trial registration Current Controlled Trials ISRCTN77769281.
doi:10.1136/bmj.f5847
PMCID: PMC3805491  PMID: 24100934
9.  A systematic review of cluster randomised trials in residential facilities for older people suggests how to improve quality 
Background
Previous reviews of cluster randomised trials have been critical of the quality of the trials reviewed, but none has explored determinants of the quality of these trials in a specific field over an extended period of time. Recent work suggests that correct conduct and reporting of these trials may require more than published guidelines. In this review, our aim was to assess the quality of cluster randomised trials conducted in residential facilities for older people, and to determine whether (1) statistician involvement in the trial and (2) strength of journal endorsement of the Consolidated Standards of Reporting Trials (CONSORT) statement influence quality.
Methods
We systematically identified trials randomising residential facilities for older people, or parts thereof, without language restrictions, up to the end of 2010, using National Library of Medicine (Medline) via PubMed and hand-searching. We based quality assessment criteria largely on the extended CONSORT statement for cluster randomised trials. We assessed statistician involvement based on statistician co-authorship, and strength of journal endorsement of the CONSORT statement from journal websites.
Results
73 trials met our inclusion criteria. Of these, 20 (27%) reported accounting for clustering in sample size calculations and 54 (74%) in the analyses. In 29 trials (40%), methods used to identify/recruit participants were judged by us to have potentially caused bias or reporting was unclear to reach a conclusion. Some elements of quality improved over time but this appeared not to be related to the publication of the extended CONSORT statement for these trials. Trials with statistician/epidemiologist co-authors were more likely to account for clustering in sample size calculations (unadjusted odds ratio 5.4, 95% confidence interval 1.1 to 26.0) and analyses (unadjusted OR 3.2, 1.2 to 8.5). Journal endorsement of the CONSORT statement was not associated with trial quality.
Conclusions
Despite international attempts to improve methods in cluster randomised trials, important quality limitations remain amongst these trials in residential facilities. Statistician involvement on trial teams may be more effective in promoting quality than further journal endorsement of the CONSORT statement. Funding bodies and journals should promote statistician involvement and co-authorship in addition to adherence to CONSORT guidelines.
doi:10.1186/1471-2288-13-127
PMCID: PMC4015673  PMID: 24148859
Residential facilities; Older people; Cluster randomised trials
10.  Self-management support for moderate-to-severe chronic obstructive pulmonary disease: a pilot randomised controlled trial 
The British Journal of General Practice  2012;62(603):e687-e695.
Background
Better self management could improve quality of life (QoL) and reduce hospital admissions in chronic obstructive pulmonary disease (COPD), but the best way to promote it remains unclear.
Aim
To explore the feasibility, effectiveness and cost effectiveness of a novel, layperson-led, theoretically driven COPD self-management support programme.
Design and setting
Pilot randomised controlled trial in one UK primary care trust area.
Method
Patients with moderate to severe COPD were identified through primary care and randomised 2:1 to the 7-week-long, group intervention or usual care. Outcomes at baseline, 2, and 6 months included self-reported health, St George’s Respiratory Questionnaire (SGRQ), EuroQol, and exercise.
Results
Forty-four per cent responded to GP invitation, 116 were randomised: mean (standard deviation [SD]) age 69.5 (9.8) years, 46% male, 78% had unscheduled COPD care in the previous year. Forty per cent of intervention patients completed the course; 35% attended no sessions; and 78% participants completed the 6-month follow-up questionnaire. Results suggest that the intervention may increase both QoL (mean EQ-5D change 0.12 (95% confidence interval [CI] = –0.02 to 0.26) higher, intervention versus control) and exercise levels, but not SGRQ score. Economic analyses suggested that with thresholds of £20 000 per quality-adjusted life-year gained, the intervention is likely to be cost-effective.
Conclusion
This intervention has good potential to meet the UK National Institute for Health and Clinical Excellence criteria for cost effectiveness, and further research is warranted. However, to make a substantial impact on COPD self-management, it will also be necessary to explore other ways to enable patients to access self-management education.
doi:10.3399/bjgp12X656829
PMCID: PMC3459776  PMID: 23265228
pilot projects; pulmonary disease, chronic obstructive; randomised controlled trial; self-care; self-management; patient education as topic; primary health care
12.  Domestic violence: knowledge, attitudes, and clinical practice of selected UK primary healthcare clinicians 
The British Journal of General Practice  2012;62(602):e647-e655.
Background
Domestic violence affects one in four women and has significant health consequences. Women experiencing abuse identify doctors and other health professionals as potential sources of support. Primary care clinicians agree that domestic violence is a healthcare issue but have been reluctant to ask women if they are experiencing abuse.
Aim
To measure selected UK primary care clinicians’ current levels of knowledge, attitudes, and clinical skills in this area.
Design and setting
Prospective observational cohort in 48 general practices from Hackney in London and Bristol, UK.
Method
Administration of the Physician Readiness to Manage Intimate Partner Violence Survey (PREMIS), comprising five sections: responder profile, background (perceived preparation and knowledge), actual knowledge, opinions, and practice issues.
Results
Two hundred and seventy-two (59%) clinicians responded. Minimal previous domestic violence training was reported by participants. Clinicians only had basic knowledge about domestic violence but expressed a positive attitude towards engaging with women experiencing abuse. Many clinicians felt poorly prepared to ask relevant questions about domestic violence or to make appropriate referrals if abuse was disclosed. Forty per cent of participants never or seldom asked about abuse when a woman presented with injuries. Eighty per cent said that they did not have an adequate knowledge of local domestic violence resources. GPs were better prepared and more knowledgeable than practice nurses; they also identified a higher number of domestic violence cases.
Conclusion
Primary care clinicians’ attitudes towards women experiencing domestic violence are generally positive but they only have basic knowledge of the area. Both GPs and practice nurses need more comprehensive training on assessment and intervention, including the availability of local domestic violence services.
doi:10.3399/bjgp12X654623
PMCID: PMC3426604  PMID: 22947586
cross-sectional studies; domestic violence; primary health care; women
13.  Study to assess the effect of a structured communication approach on quality of life in secure mental health settings (Comquol): study protocol for a pilot cluster randomized trial 
Trials  2013;14:257.
Background
Forensic mental health services have largely ignored examining patients’ views on the nature of the services offered to them. A structured communication approach (DIALOG) has been developed with the aim of placing the patient’s perspective on their care at the heart of the discussions between patients and clinicians. The effectiveness of the structured communication approach in community mental health services has been demonstrated, but no trial has taken place in a secure psychiatric setting. This pilot study is evaluating a 6-month intervention combining DIALOG with principles of solution-focused therapy on quality of life in medium-secure settings.
Methods and design
A cluster randomized controlled trial design is being employed to conduct a 36-month pilot study. Participants are recruited from six medium-secure inpatient services, with 48 patients in the intervention group and 48 in the control group. The intervention uses a structured communication approach. It comprises six meetings between patient and nurse held monthly over a 6-month period. During each meeting, patients rate their satisfaction with a range of life and treatment domains with responses displayed on a tablet. The rating is followed by a discussion of how to improve the current situation in those domains identified by the patient. Assessments take place prior to the intervention (baseline), at 6 months (postintervention) and at 12 months (follow-up). The primary outcome is the patient’s self-reported quality of life.
Discussion
This study aims to (1) establish the feasibility of the trial design as the basis for determining the viability of a large full-scale trial, (2) determine the variability of the outcomes of interest (quality of life, levels of satisfaction, disturbance, ward climate and engagement with services), (3) estimate the costs of the intervention and (4) refine the intervention following the outcome of the study based upon the experiences of the nurses and patients. The intervention allows patients to have a greater say in how they are treated and targets care in areas that patients identify as important to them. It is intended to establish systems that support meaningful patient and caregiver involvement and participation.
Trial registration
Current Controlled Trials, ISRCTN34145189
doi:10.1186/1745-6215-14-257
PMCID: PMC3765869  PMID: 23947774
Comquol; DIALOG; Forensic; Mental health; Quality of life; Solution-focused brief therapy
14.  Consent processes in cluster-randomised trials in residential facilities for older adults: a systematic review of reporting practices and proposed guidelines 
BMJ Open  2013;3(7):e003057.
Objective
To assess the quality of reported consent processes of cluster-randomised trials conducted in residential facilities for older people and to explore whether the focus on improving the general conduct and reporting of cluster-randomised trials influenced the quality of conduct and reporting of ethical processes in these trials.
Design
Systematic review of cluster-randomised trials reports, published up to the end of 2010.
Data sources
National Library of Medicine (Medline) via PubMed, hand-searches of BMJ, Journal of the American Medical Association, BMC Health Services Research, Age and Ageing and Journal of the American Geriatrics Society, reference search in Web of Knowledge and consultation with experts.
Eligibility for selecting studies
Published cluster-randomised trials where the unit of randomisation is a part or the whole of a residential facility for older people, without language or year of publication restrictions.
Results
We included 73 trials. Authors reported ethical approval in 59, obtaining individual consent in 51, and using proxies for this consent in 37, but the process to assess residents’ capacity to consent was clearly reported in only eight. We rated only six trials high for the quality of consent processes. We considered that individual informed consent could have been waived legitimately in 14  of 22 trials not reporting obtaining consent. The proportions reporting ethical approval and quality of consent processes were higher in recent trials.
Conclusions
Recently published international recommendations regarding ethical conduct in cluster-randomised trials are much needed. In relation to consent processes when cognitively impaired individuals are included in these trials, we provide a six-point checklist and recommend the minimum information to be reported. Those who lack capacity in trials with complex designs should be afforded the same care in relation to consent as competent adults in trials with simpler designs.
doi:10.1136/bmjopen-2013-003057
PMCID: PMC3710983  PMID: 23836761
Medical ethics; Statistics & research methods; Geriatric medicine
15.  Exercise for depression in elderly residents of care homes: a cluster-randomised controlled trial 
Lancet  2013;382(9886):41-49.
Summary
Background
Depression is common and is associated with poor outcomes among elderly care-home residents. Exercise is a promising low-risk intervention for depression in this population. We tested the hypothesis that a moderate intensity exercise programme would reduce the burden of depressive symptoms in residents of care homes.
Methods
We did a cluster-randomised controlled trial in care homes in two regions in England; northeast London, and Coventry and Warwickshire. Residents aged 65 years or older were eligible for inclusion. A statistician independent of the study randomised each home (1 to 1·5 ratio, stratified by location, minimised by type of home provider [local authority, voluntary, private and care home, private and nursing home] and size of home [<32 or ≥32 residents]) into intervention and control groups. The intervention package included depression awareness training for care-home staff, 45 min physiotherapist-led group exercise sessions for residents (delivered twice weekly), and a whole home component designed to encourage more physical activity in daily life. The control consisted of only the depression awareness training. Researchers collecting follow-up data from individual participants and the participants themselves were inevitably aware of home randomisation because of the physiotherapists' activities within the home. A researcher masked to study allocation coded NHS routine data. The primary outcome was number of depressive symptoms on the geriatric depression scale-15 (GDS-15). Follow-up was for 12 months. This trial is registered with ISRCTN Register, number ISRCTN43769277.
Findings
Care homes were randomised between Dec 15, 2008, and April 9, 2010. At randomisation, 891 individuals in 78 care homes (35 intervention, 43 control) had provided baseline data. We delivered 3191 group exercise sessions attended on average by five study participants and five non-study residents. Of residents with a GDS-15 score, 374 of 765 (49%) were depressed at baseline; 484 of 765 (63%) provided 12 month follow-up scores. Overall the GDS-15 score was 0·13 (95% CI −0·33 to 0·60) points higher (worse) at 12 months for the intervention group compared with the control group. Among residents depressed at baseline, GDS-15 score was 0·22 (95% CI −0·52 to 0·95) points higher at 6 months in the intervention group than in the control group. In an end of study cross-sectional analysis, including 132 additional residents joining after randomisation, the odds of being depressed were 0·76 (95% CI 0·53 to 1·09) for the intervention group compared with the control group.
Interpretation
This moderately intense exercise programme did not reduce depressive symptoms in residents of care homes. In this frail population, alternative strategies to manage psychological symptoms are required.
Funding
National Institute for Health Research Health Technology Assessment.
doi:10.1016/S0140-6736(13)60649-2
PMCID: PMC3919159  PMID: 23643112
16.  Prevalence and impact of chronic widespread pain in the Bangladeshi and White populations of Tower Hamlets, East London 
Clinical Rheumatology  2013;32:1375-1382.
The prevalence and impact of chronic pain differ between ethnic groups. We report a study of the comparative prevalence and impact of chronic pain in Bangladeshi, British Bangladeshi and White British/Irish people. We posted a short questionnaire to a random sample of 4,480 patients registered with 16 general practices in the London Borough of Tower Hamlets and conducted a longer questionnaire with patients in the waiting areas at those practices. We distinguished between Bangladeshi participants who were born in the UK or had arrived in the UK at the age of 14 or under (British Bangladeshi) and those who arrived in UK at the age of over 14 (Bangladeshi). We obtained 1,223/4,480 (27 %) responses to the short survey and 600/637 (94 %) to the long survey. From the former, the prevalence of chronic pain in the White, British Bangladeshi and Bangladeshi groups was 55, 54 and 72 %, respectively. The corresponding figures from the long survey were 49, 45 and 70 %. Chronic widespread pain was commoner in the Bangladeshi (16 %) than in the White (10 %) or British Bangladeshi (9 %) groups. People with chronic pain experienced poorer quality of life (odds ratio for scoring best possible health vs. good health (or good vs. poor health) 5.6 (95 % confidence interval 3.4 to 9.8)), but we found no evidence of differences between ethnic groups in the impact of chronic pain on the quality of life. Chronic pain is commoner and, of greater severity, in Bangladeshis than in Whites. On most measures in this study, British Bangladeshis resembled the Whites more than the Bangladeshis.
Electronic supplementary material
The online version of this article (doi:10.1007/s10067-013-2286-3) contains supplementary material, which is available to authorized users.
doi:10.1007/s10067-013-2286-3
PMCID: PMC3751214  PMID: 23719834
Chronic pain; Comparative prevalence; Ethnicity; Quality of life
17.  Clinicians' perceptions of reporting methods for back pain trials: a qualitative study 
The British Journal of General Practice  2012;62(596):e151-e159.
Background
How outcomes of clinical trials are reported alters the way treatment effectiveness is perceived: clinicians interpret the outcomes of trials more favourably when results are presented in relative (such as risk ratio) rather than absolute terms (such as risk reduction). However, it is unclear which methods clinicians find easiest to interpret and use in decision making.
Aim
To explore which methods for reporting back pain trials clinicians find clearest and most interpretable and useful to decision making.
Design and setting
Indepth interviews with clinicians at clinical practices/research centre.
Method
Clinicians were purposively sampled by professional discipline, sex, age, and practice setting. They were presented with several different summaries of the results of the same hypothetical trial. Each summary used a different reporting method, and the study explored participants' preferences for each method and how they would like to see future trials reported.
Results
The 14 clinicians interviewed (comprising GPs, manual therapists, psychologists, a rheumatologist, and surgeons) stated that clinical trial reports were not written with them in mind. They were familiar with mean differences, proportion improved, and numbers needed to treat (NNT), but unfamiliar with standardised mean differences, odds ratios, and relative risks (RRs). They found the proportion improved, RR, and NNT most intuitively understandable, and thought reporting between-group mean differences, RRs, and odds ratios could mislead.
Conclusion
Clinicians stated that additional reporting methods facilitate the interpretation of trial results, and using a variety of methods would make results easier to interpret in context and incorporate into practice. Authors of future back pain trials should report data in a format that is accessible to clinicians.
doi:10.3399/bjgp12X630034
PMCID: PMC3289820  PMID: 22429424
back pain; data interpretation, statistical; outcome assessment (health care); primary care; qualitative research; randomised controlled trials; treatment outcome
18.  Effectiveness and cost-effectiveness of a novel, group self-management course for adults with chronic musculoskeletal pain: study protocol for a multicentre, randomised controlled trial (COPERS) 
BMJ Open  2013;3(1):e002492.
Introduction
Chronic musculoskeletal pain is a common condition that often responds poorly to treatment. Self-management courses have been advocated as a non-drug pain management technique, although evidence for their effectiveness is equivocal. We designed and piloted a self-management course based on evidence for effectiveness for specific course components and characteristics.
Methods/analysis
COPERS (coping with persistent pain, effectiveness research into self-management) is a pragmatic randomised controlled trial testing the effectiveness and cost-effectiveness of an intensive, group, cognitive behavioural-based, theoretically informed and manualised self-management course for chronic pain patients against a control of best usual care: a pain education booklet and a relaxation CD. The course lasts for 15 h, spread over 3 days, with a –2 h follow-up session 2 weeks later. We aim to recruit 685 participants with chronic musculoskeletal pain from primary, intermediate and secondary care services in two UK regions. The study is powered to show a standardised mean difference of 0.3 in the primary outcome, pain-related disability. Secondary outcomes include generic health-related quality of life, healthcare utilisation, pain self-efficacy, coping, depression, anxiety and social engagement. Outcomes are measured at 6 and 12 months postrandomisation. Pain self-efficacy is measured at 3 months to assess whether change mediates clinical effect.
Ethics/dissemination
Ethics approval was given by Cambridgeshire Ethics 11/EE/046. This trial will provide robust data on the effectiveness and cost-effectiveness of an evidence-based, group self-management programme for chronic musculoskeletal pain. The published outcomes will help to inform future policy and practice around such self-management courses, both nationally and internationally.
Trial registration
ISRCTN24426731.
doi:10.1136/bmjopen-2012-002492
PMCID: PMC3563130  PMID: 23358564
Randomised Controlled Trial; Protocol; Chronic Pain; Self Management
19.  Effectiveness and cost-effectiveness of body psychotherapy in the treatment of negative symptoms of schizophrenia – a multi-centre randomised controlled trial 
BMC Psychiatry  2013;13:26.
Background
Negative symptoms of schizophrenia are frequently associated with poor long term outcomes. Established interventions have little, if any, positive effects on negative symptoms. Arts Therapies such as Body Psychotherapy (BPT) have been suggested to reduce negative symptoms, but the existing evidence is limited. In a small exploratory trial a manualised form of group BPT led to significantly lower negative symptom levels both at the end of treatment and at 4 months follow-up as compared to supportive counseling. We designed a large multi-site trial to assess the effectiveness of a manualised BPT intervention in reducing negative symptoms, compared to an active control.
Methods/Design
In a randomised controlled trial, 256 schizophrenic outpatients with negative symptoms will be randomly allocated either to BPT or Pilates groups. In both conditions, patients will be offered two 90 minutes sessions per week in groups of about 8 patients over a period of 10 weeks. Outcomes are assessed at the end of treatment and at six months follow-up. The primary outcome is severity of negative symptoms, as measured by the Positive and Negative Symptom Scale (PANSS), whilst a range of secondary outcome measures include general psychopathology, social contacts, and quality of life. We will also assess the cost-effectiveness of the intervention.
Discussion
The study aims to evaluate the effectiveness of a promising form of group therapy which may help alleviate negative symptoms that are associated with unfavourable long-term outcomes and have so far been difficult to treat. If the trial is successful, it will add a new and effective option in the treatment of negative symptoms. Group BPT is manualised, might be attractive to many patients because of its unusual approach, and could potentially be rolled out to services at relatively little additional cost.
Trial registration
Current Controlled Trials ISRCTN84216587
doi:10.1186/1471-244X-13-26
PMCID: PMC3556155  PMID: 23317474
20.  Impact of Asthma on Educational Attainment in a Socioeconomically Deprived Population: A Study Linking Health, Education and Social Care Datasets 
PLoS ONE  2012;7(11):e43977.
Background
Asthma has the potential to adversely affect children's school examination performance, and hence longer term life chances. Asthma morbidity is especially high amongst UK ethnic minority children and those experiencing social adversity, populations which also have poor educational outcomes. We tested the hypothesis that asthma adversely affects performance in national school examinations in a large cohort from an area of ethnic diversity and social deprivation.
Methods and Findings
With a novel method (using patient and address-matching algorithms) we linked administrative and clinical data for 2002–2005 for children in east London aged 5–14 years to contemporaneous education and social care datasets. We modelled children's performance in school examinations in relation to socio-demographic and clinical variables.
The dataset captured examination performance for 12,136 children who sat at least one national examination at Key Stages 1–3. For illustration, estimates are presented as percentage changes in Key Stage 2 results. Having asthma was associated with a 1.1% increase in examination scores (95%CI 0.4 to 1.7)%,p = 0.02. Worse scores were associated with Bangladeshi ethnicity −1.3%(−2.5 to −0.1)%,p = 0.03; special educational need −14.6%(−15.7 to −13.5)%,p = 0.02; mental health problems −2.5%(−4.1 to −0.9)%,p = 0.003, and social adversity: living in a smoking household −1.2(−1.7 to −0.6)%,p<0.001; living in social housing −0.8%(−1.3 to −0.2)% p = 0.01, and entitlement to free school meals −0.8%(−1.5 to −0.1)%,p<0.001.
Conclusions
Social adversity and ethnicity, but not asthma, are associated with poorer performance in national school examinations. Policies to improve educational attainment in socially deprived areas should focus on these factors.
doi:10.1371/journal.pone.0043977
PMCID: PMC3498297  PMID: 23155367
21.  The Olympic Regeneration in East London (ORiEL) study: protocol for a prospective controlled quasi-experiment to evaluate the impact of urban regeneration on young people and their families 
BMJ Open  2012;2(4):e001840.
Introduction
Recent systematic reviews suggest that there is a dearth of evidence on the effectiveness of large-scale urban regeneration programmes in improving health and well-being and alleviating health inequalities. The development of the Olympic Park in Stratford for the London 2012 Olympic and Paralympic Games provides the opportunity to take advantage of a natural experiment to examine the impact of large-scale urban regeneration on the health and well-being of young people and their families.
Design and methods
A prospective school-based survey of adolescents (11–12 years) with parent data collected through face-to-face interviews at home. Adolescents will be recruited from six randomly selected schools in an area receiving large-scale urban regeneration (London Borough of Newham) and compared with adolescents in 18 schools in three comparison areas with no equivalent regeneration (London Boroughs of Tower Hamlets, Hackney and Barking & Dagenham). Baseline data will be completed prior to the start of the London Olympics (July 2012) with follow-up at 6 and 18 months postintervention. Primary outcomes are: pre–post change in adolescent and parent mental health and well-being, physical activity and parental employment status. Secondary outcomes include: pre–post change in social cohesion, smoking, alcohol use, diet and body mass index. The study will account for individual and environmental contextual effects in evaluating changes to identified outcomes. A nested longitudinal qualitative study will explore families’ experiences of regeneration in order to unpack the process by which regeneration impacts on health and well-being.
Ethics and dissemination
The study has approval from Queen Mary University of London Ethics Committee (QMREC2011/40), the Association of Directors of Children's Services (RGE110927) and the London Boroughs Research Governance Framework (CERGF113). Fieldworkers have had advanced Criminal Records Bureau clearance. Findings will be disseminated through peer-reviewed publications, national and international conferences, through participating schools and the study website (http://www.orielproject.co.uk).
doi:10.1136/bmjopen-2012-001840
PMCID: PMC3432843  PMID: 22936822
22.  Cost-effectiveness of Identification and Referral to Improve Safety (IRIS), a domestic violence training and support programme for primary care: a modelling study based on a randomised controlled trial 
BMJ Open  2012;2(3):e001008.
Objective
The Identification and Referral to Improve Safety (IRIS) cluster randomised controlled trial tested the effectiveness of a training and support intervention to improve the response of primary care to women experiencing domestic violence (DV). The aim of this study is to estimate the cost-effectiveness of this intervention.
Design
Markov model-based cost-effectiveness analysis.
Setting
General practices in two urban areas in the UK.
Participants
Simulated female individuals from the general UK population who were registered at general practices, aged 16 years and older.
Intervention
General practices received staff training, prompts to ask women about DV embedded in the electronic medical record, a care pathway including referral to a specialist DV agency and continuing contact from that agency. The trial compared the rate of referrals of women with specialist DV agencies from 24 general practices that received the IRIS programme with 24 general practices not receiving the programme. The trial did not measure outcomes for women beyond the intermediate outcome of referral to specialist agencies. The Markov model extrapolated the trial results to estimate the long-term healthcare and societal costs and benefits using data from other trials and epidemiological studies.
Results
The intervention would produce societal cost savings per woman registered in the general practice of UK£37 (95% CI £178 saved to a cost of £136) over 1 year. The incremental quality-adjusted life-year was estimated to be 0.0010 (95% CI −0.0157 to 0.0101) per woman. Probabilistic sensitivity analysis found 78% of model replications under a willingness to pay threshold of £20 000 per quality-adjusted life-year.
Conclusions
The IRIS programme is likely to be cost-effective and possibly cost saving from a societal perspective. Better data on the trajectory of abuse and the effect of advocacy are needed for a more robust model.
Trial registration
Current Controlled Trials, ISRCTN74012786.
Article summary
Article focus
The aim of this study was to assess the cost-effectiveness of the IRIS training and support intervention for primary care clinicians from the UK societal and NHS perspectives.
Key messages
The intervention is likely to be cost saving from a societal perspective with a high likelihood of being under a £20 000 per quality-adjusted life-year willingness to pay threshold.
Strengths and limitations of this study
We have minimised bias in estimating the effect size of the IRIS programme by basing it on a randomised controlled trial.
By using epidemiological and cost data external to the trial, we were able to extrapolate from directly measured trial outcomes (DV disclosure and referral rates) to quality of life, health and economic outcomes.
The uncertainty of the transition probabilities based on assumptions was addressed by probabilistic sensitivity analysis, contributing to the robustness of the model.
Important limitations of that data are the paucity of longitudinal studies measuring the trajectory of abuse and uncertainty about the effect of DV advocacy for women not living in a refuge or shelter.
doi:10.1136/bmjopen-2012-001008
PMCID: PMC3383977  PMID: 22730555
23.  Is access to specialist assessment of chest pain equitable by age, gender, ethnicity and socioeconomic status? An enhanced ecological analysis 
BMJ Open  2012;2(3):e001025.
Objectives
To determine whether access to rapid access chest pain clinics of people with recent onset symptoms is equitable by age, socioeconomic status, ethnicity and gender, according to need.
Design
Retrospective cohort study with ecological analysis.
Setting
Patients referred from primary care to five rapid access chest pain clinics in secondary care, across England.
Participants
Of 8647 patients aged ≥35 years referred to chest pain clinics with new-onset stable chest pain but no known cardiac history, 7570 with documented census ward codes, age, gender and ethnicity comprised the study group. Patients excluded were those with missing date of birth, gender or ethnicity (n=782) and those with missing census ward codes (n=295).
Outcome measures
Effects of age, gender, ethnicity and socioeconomic status on clinic attendance were calculated as attendance rate ratios, with number of attendances as the outcome and resident population-years as the exposure in each stratum, using Poisson regression. Attendance rate ratios were then compared with coronary heart disease (CHD) mortality ratios to determine whether attendance was equitable according to need.
Results
Adjusted attendance rate ratios for patients aged >65 years were similar to younger patients (1.1, 95% CI 1.05 to 1.16), despite population CHD mortality rate ratios nearly 15 times higher in the older age group. Women had lower attendance rate ratios (0.81, 95% CI 0.77 to 0.84) and also lower population CHD mortality rate ratios compared with men. South Asians had higher attendance rates (1.67, 95% CI 1.57 to 1.77) compared with whites and had a higher standardised CHD mortality ratio of 1.46 (95% CI 1.41 to 1.51). Although univariable analysis showed that the most deprived patients (quintile 5) had an attendance rate twice that of less deprived quintiles, the adjusted analysis showed their attendance to be 13% lower (0.87, 95% CI 0.81 to 0.94) despite a higher population CHD mortality rate.
Conclusion
There is evidence of underutilisation of chest pain clinics by older people and those from lower socioeconomic status. More robust and patient focused administrative pathways need to be developed to detect inequity, correction of which has the potential to substantially reduce coronary mortality.
Article summary
Article focus
Is access to chest pain clinics of people with recent onset symptoms equitable according to local need and consistent with national policy.
Key messages
Need for evaluation in chest pain clinics will vary according to the variable incidence of heart disease in different age, gender, socioeconomic and ethnic groups.
There is evidence of underutilisation of chest pain clinics by older people and those from lower socioeconomic status.
Strengths and limitations of this study
Large, diverse and unselected patient population with uniformly collected patient-level data, allowing robust comparisons between demographic and clinical groups.
Ecological fallacy with respect to age and sex has been avoided by applying an enhanced ecological analysis.
Need to use census wards, not postcodes, as the smallest geographical areas for which mortality and demographic data were available.
Ethnicity was not based on self-ascription.
doi:10.1136/bmjopen-2012-001025
PMCID: PMC3378943  PMID: 22700834
25.  Withdrawal of inhaled corticosteroids in individuals with COPD - a systematic review and comment on trial methodology 
Respiratory Research  2011;12(1):107.
Inhaled corticosteroids (ICS) reduce COPD exacerbation frequency and slow decline in health related quality of life but have little effect on lung function, do not reduce mortality, and increase the risk of pneumonia. We systematically reviewed trials in which ICS have been withdrawn from patients with COPD, with the aim of determining the effect of withdrawal, understanding the differing results between trials, and making recommendations for improving methodology in future trials where medication is withdrawn. Trials were identified by two independent reviewers using MEDLINE, EMBASE and CINAHL, citations of identified studies were checked, and experts contacted to identify further studies. Data extraction was completed independently by two reviewers. The methodological quality of each trial was determined by assessing possible sources of systematic bias as recommended by the Cochrane collaboration. We included four trials; the quality of three was adequate. In all trials, outcomes were generally worse for patients who had had ICS withdrawn, but differences between outcomes for these patients and patients who continued with medication were mostly small and not statistically significant. Due to data paucity we performed only one meta-analysis; this indicated that patients who had had medication withdrawn were 1.11 (95% CI 0.84 to 1.46) times more likely to have an exacerbation in the following year, but the definition of exacerbations was not consistent between the three trials, and the impact of withdrawal was smaller in recent trials which were also trials conducted under conditions that reflected routine practice. There is no evidence from this review that withdrawing ICS in routine practice results in important deterioration in patient outcomes. Furthermore, the extent of increase in exacerbations depends on the way exacerbations are defined and managed and may depend on the use of other medication. In trials where medication is withdrawn, investigators should report other medication use, definitions of exacerbations and management of patients clearly. Intention to treat analyses should be used and interpreted appropriately.
doi:10.1186/1465-9921-12-107
PMCID: PMC3185272  PMID: 21838890

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