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1.  Better management of multimorbidity: a critical look at the ‘Ariadne principles’ 
BMC Medicine  2014;12(1):222.
Primary care clinicians and researchers are growing increasingly aware of the prevalence of multimorbidity among long-term conditions, and the impact on patient experience, health, and utilisation of care. The correspondence paper by Muth et al. entitled ‘The Ariadne principles: how to handle multimorbidity in primary care consultations’ outlines new thinking on a better way to manage the challenges of decision-making in multimorbidity. The paper highlights the importance of shared treatment goals as a fundamental basis for more effective management. Although a welcome contribution to the literature, the principles raise a number of challenges: the complexities of achieving effective patient-centred assessment and goal-setting; how best to encourage implementation of new practices; and the current state of the evidence around multimorbidity and its management.
Please see related article: http://www.biomedcentral.com/1741-7015/12/223.
doi:10.1186/s12916-014-0222-2
PMCID: PMC4258943  PMID: 25484120
Assessment; Multimorbidity; Treatment burden; Treatment goals
2.  Predictors of patient self-report of chronic kidney disease: baseline analysis of a randomised controlled trial 
BMC Family Practice  2014;15(1):196.
Background
Improving the quality of care for patients with vascular disease is a priority. Clinical guidance has emphasised the importance of early identification and active management of chronic kidney disease (CKD) in primary care in order to maintain vascular health. However, awareness of stage 3 CKD amongst patients remains limited. We aimed to identify predictors of patient self-report of CKD to inform tailoring of conversations around CKD in primary care for diverse patient populations.
Methods
We conducted a cross-sectional analysis of baseline data from 436 patients with stage 3 CKD from 24 GP practices taking part in a randomised controlled trial (RCT) evaluating a complex self-management intervention, which aimed to support the maintenance of vascular health in patients with stage 3 CKD. Potential predictors of patient self-report of CKD included demographics, stage of CKD, cardiovascular risk, self-reported co-morbidities, health status, self-management ability, and health service utilisation.
Results
Around half (52%, n = 227) of patients did not self-report CKD. Self-report rates did not appreciably differ by practice. Multivariate analysis revealed that female patients (p = 0.004), and patients with stage 3b CKD (p < 0.001), and with higher anxiety levels (p < 0.001), were more likely to self-report CKD.
Conclusions
Self-report of kidney problems by patients on CKD registers was variable and patterned by sociodemographic factors. Although it cannot be assumed that failure to self-report indicates a lack of awareness of CKD, our data do suggest the need for greater consistency in discussions around kidney health, with meaningful and relevant clinical dialogue that is aligned with existing clinical encounters to enable shared decision making and minimise anxiety.
Electronic supplementary material
The online version of this article (doi:10.1186/s12875-014-0196-3) contains supplementary material, which is available to authorized users.
doi:10.1186/s12875-014-0196-3
PMCID: PMC4260196  PMID: 25433525
Kidney diseases; Primary health care; Self-report; Awareness; Predictors; Communication; Self-management
3.  Capacity, responsibility, and motivation: a critical qualitative evaluation of patient and practitioner views about barriers to self-management in people with multimorbidity 
Background
Primary care is increasingly focussed on the care of people with two or more long-term conditions (multimorbidity). The UK Department of Health strategy for long term conditions is to use self-management support for the majority of patients but there is evidence of limited engagement among primary care professionals and patients with multimorbidity. Furthermore, multimorbidity is more common in areas of socioeconomic deprivation but deprivation may act as a barrier to patient engagement in self-management practices.
Background
Effective self-management is considered critical to meet the needs of people living with long term conditions but achieving this is a significant challenge in patients with multimorbidity. This study aimed to explore patient and practitioner views on factors influencing engagement in self-management in the context of multimorbidity.
Methods
A qualitative study using individual semi-structured interviews with 20 patients and 20 practitioners drawn from four general practices in Greater Manchester situated in areas of high and low social deprivation.
Patients were purposively sampled on socioeconomic deprivation (defined by Index of Multiple Deprivation (IMD) score), number and type of long term conditions (2 or more of: coronary heart disease, diabetes mellitus, osteoarthritis, chronic obstructive pulmonary disease and depression), age and gender. Practitioners were sampled by deprivation status of the practice area; role (i.e. salaried GP, GP principal, practice nurse); and number of years’ experience. Interviews were audio-recorded and transcribed verbatim. Analysis used a thematic approach based on Framework.
Results
Three main factors were identified as influencing patient engagement in self-management: capacity (access and availability of socio-economic resources and time; knowledge; and emotional and physical energy), responsibility (the degree to which patients and practitioners agreed about the division of labour about chronic disease management, including self-management) and motivation (willingness to take-up types of self-management practices). Socioeconomic deprivation negatively impacted on all three factors. Motivation was especially reduced in the presence of mental and physical multimorbidity.
Conclusion
Full engagement in self-management practices in multimorbidity was only present where patients’ articulated a sense of capacity, responsibility, and motivation. Patient ‘know-how’ or interpretive capacity to self-manage multimorbidity is potentially an important precursor to responsibility and motivation, and might be a critical target for intervention. However, individual and social resources are needed to generate capacity, responsibility, and motivation for self-management, pointing to a balanced role for health services and wider enabling networks.
Electronic supplementary material
The online version of this article (doi:10.1186/s12913-014-0536-y) contains supplementary material, which is available to authorized users.
doi:10.1186/s12913-014-0536-y
PMCID: PMC4226873  PMID: 25367263
4.  Systematic techniques for assisting recruitment to trials (START): study protocol for embedded, randomized controlled trials 
Trials  2014;15(1):407.
Background
Randomized controlled trials play a central role in evidence-based practice, but recruitment of participants, and retention of them once in the trial, is challenging. Moreover, there is a dearth of evidence that research teams can use to inform the development of their recruitment and retention strategies. As with other healthcare initiatives, the fairest test of the effectiveness of a recruitment strategy is a trial comparing alternatives, which for recruitment would mean embedding a recruitment trial within an ongoing host trial. Systematic reviews indicate that such studies are rare. Embedded trials are largely delivered in an ad hoc way, with interventions almost always developed in isolation and tested in the context of a single host trial, limiting their ability to contribute to a body of evidence with regard to a single recruitment intervention and to researchers working in different contexts.
Methods/Design
The Systematic Techniques for Assisting Recruitment to Trials (START) program is funded by the United Kingdom Medical Research Council (MRC) Methodology Research Programme to support the routine adoption of embedded trials to test standardized recruitment interventions across ongoing host trials. To achieve this aim, the program involves three interrelated work packages: (1) methodology - to develop guidelines for the design, analysis and reporting of embedded recruitment studies; (2) interventions - to develop effective and useful recruitment interventions; and (3) implementation - to recruit host trials and test interventions through embedded studies.
Discussion
Successful completion of the START program will provide a model for a platform for the wider trials community to use to evaluate recruitment interventions or, potentially, other types of intervention linked to trial conduct. It will also increase the evidence base for two types of recruitment intervention.
Trial registration
The START protocol covers the methodology for embedded trials. Each embedded trial is registered separately or as a substudy of the host trial.
doi:10.1186/1745-6215-15-407
PMCID: PMC4230578  PMID: 25344684
Randomized controlled trial; Recruitment; Primary care; Community; Trial participation; Intervention; Multimedia; Decision support systems; Protocols; Participant information
5.  Effect of Information and Telephone-Guided Access to Community Support for People with Chronic Kidney Disease: Randomised Controlled Trial 
PLoS ONE  2014;9(10):e109135.
Background
Implementation of self-management support in traditional primary care settings has proved difficult, encouraging the development of alternative models which actively link to community resources. Chronic kidney disease (CKD) is a common condition usually diagnosed in the presence of other co-morbidities. This trial aimed to determine the effectiveness of an intervention to provide information and telephone-guided access to community support versus usual care for patients with stage 3 CKD.
Methods and Findings
In a pragmatic, two-arm, patient level randomised controlled trial 436 patients with a diagnosis of stage 3 CKD were recruited from 24 general practices in Greater Manchester. Patients were randomised to intervention (215) or usual care (221). Primary outcome measures were health related quality of life (EQ-5D health questionnaire), blood pressure control, and positive and active engagement in life (heiQ) at 6 months. At 6 months, mean health related quality of life was significantly higher for the intervention group (adjusted mean difference = 0.05; 95% CI = 0.01, 0.08) and blood pressure was controlled for a significantly greater proportion of patients in the intervention group (adjusted odds-ratio = 1.85; 95% CI = 1.25, 2.72). Patients did not differ significantly in positive and active engagement in life. The intervention group reported a reduction in costs compared with control.
Conclusions
An intervention to provide tailored information and telephone-guided access to community resources was associated with modest but significant improvements in health related quality of life and better maintenance of blood pressure control for patients with stage 3 CKD compared with usual care. However, further research is required to identify the mechanisms of action of the intervention.
Trial Registration
Controlled-Trials.com ISRCTN45433299
doi:10.1371/journal.pone.0109135
PMCID: PMC4199782  PMID: 25330169
6.  Interventions to improve recruitment and retention in clinical trials: a survey and workshop to assess current practice and future priorities 
Trials  2014;15(1):399.
Background
Despite significant investment in infrastructure many trials continue to face challenges in recruitment and retention. We argue that insufficient focus has been placed on the development and testing of recruitment and retention interventions.
Methods
In this current paper, we summarize existing reviews about interventions to improve recruitment and retention. We report survey data from Clinical Trials Units in the United Kingdom to indicate the range of interventions used by these units to encourage recruitment and retention. We present the views of participants in a recent workshop and a priority list of recruitment interventions for evaluation (determined by voting among workshop participants). We also discuss wider issues concerning the testing of recruitment interventions.
Results
Methods used to encourage recruitment and retention were categorized as: patient contact, patient convenience, support for recruiters, monitoring and systems, incentives, design, resources, and human factors. Interventions felt to merit investigation by respondents fell into three categories: training site staff, communication with patients, and incentives.
Conclusions
Significant resources continue to be invested into clinical trials and other high quality studies, but recruitment remains a significant challenge. Adoption of innovative methods to develop, test, and implement recruitment interventions are required.
Electronic supplementary material
The online version of this article (doi:10.1186/1745-6215-15-399) contains supplementary material, which is available to authorized users.
doi:10.1186/1745-6215-15-399
PMCID: PMC4210542  PMID: 25322807
Trials; Recruitment; Retention
7.  Characteristics of Effective Collaborative Care for Treatment of Depression: A Systematic Review and Meta-Regression of 74 Randomised Controlled Trials 
PLoS ONE  2014;9(9):e108114.
Background
Collaborative care is a complex intervention based on chronic disease management models and is effective in the management of depression. However, there is still uncertainty about which components of collaborative care are effective. We used meta-regression to identify factors in collaborative care associated with improvement in patient outcomes (depressive symptoms) and the process of care (use of anti-depressant medication).
Methods and Findings
Systematic review with meta-regression. The Cochrane Collaboration Depression, Anxiety and Neurosis Group trials registers were searched from inception to 9th February 2012. An update was run in the CENTRAL trials database on 29th December 2013. Inclusion criteria were: randomised controlled trials of collaborative care for adults ≥18 years with a primary diagnosis of depression or mixed anxiety and depressive disorder. Random effects meta-regression was used to estimate regression coefficients with 95% confidence intervals (CIs) between study level covariates and depressive symptoms and relative risk (95% CI) and anti-depressant use. The association between anti-depressant use and improvement in depression was also explored. Seventy four trials were identified (85 comparisons, across 21,345 participants). Collaborative care that included psychological interventions predicted improvement in depression (β coefficient −0.11, 95% CI −0.20 to −0.01, p = 0.03). Systematic identification of patients (relative risk 1.43, 95% CI 1.12 to 1.81, p = 0.004) and the presence of a chronic physical condition (relative risk 1.32, 95% CI 1.05 to 1.65, p = 0.02) predicted use of anti-depressant medication.
Conclusion
Trials of collaborative care that included psychological treatment, with or without anti-depressant medication, appeared to improve depression more than those without psychological treatment. Trials that used systematic methods to identify patients with depression and also trials that included patients with a chronic physical condition reported improved use of anti-depressant medication. However, these findings are limited by the observational nature of meta-regression, incomplete data reporting, and the use of study aggregates.
doi:10.1371/journal.pone.0108114
PMCID: PMC4180075  PMID: 25264616
8.  Antenatal interventions for reducing weight in obese women for improving pregnancy outcome 
This is the protocol for a review and there is no abstract. The objectives are as follows:
To evaluate the effectiveness of interventions that reduce weight in obese pregnant women.
doi:10.1002/14651858.CD009334
PMCID: PMC4176657  PMID: 25267915
9.  Self-management support interventions to reduce health care utilisation without compromising outcomes: a systematic review and meta-analysis 
Background
There is increasing interest in the role of ‘self-management’ interventions to support the management of long-term conditions in health service settings. Self-management may include patient education, support for decision-making, self-monitoring and psychological and social support. Self-management support has potential to improve the efficiency of health services by reducing other forms of utilisation (such as primary care or hospital use), but a shift to self-management may lead to negative outcomes, such as patients who feel more anxious about their health, are less able to cope, or who receive worse quality of care, all of which may impact on their health and quality of life. We sought to determine which models of self-management support are associated with significant reductions in health services utilisation without compromising outcomes among patients with long-term conditions.
Methods
We used systematic review with meta-analysis. We included randomised controlled trials in patients with long-term conditions which included self-management support interventions and reported measures of service utilisation or costs, as well as measures of health outcomes (standardized disease specific quality of life, generic quality of life, or depression/anxiety).We searched multiple databases (CENTRAL, CINAHL, Econlit, EMBASE, HEED, MEDLINE, NHS EED and PsycINFO) and the reference lists of published reviews. We calculated effects sizes for both outcomes and costs, and presented the results in permutation plots, as well as conventional meta-analyses.
Results
We included 184 studies. Self-management support was associated with small but significant improvements in health outcomes, with the best evidence of effectiveness in patients with diabetic, respiratory, cardiovascular and mental health conditions. Only a minority of self-management support interventions reported reductions in health care utilisation in association with decrements in health. Evidence for reductions in utilisation associated with self-management support was strongest in respiratory and cardiovascular problems. Studies at higher risk of bias were more likely to report benefits.
Conclusions
Self-management support interventions can reduce health service utilization without compromising patient health outcomes, although effects were generally small, and the evidence was strongest in respiratory and cardiovascular disorders. Further work is needed to determine which components of self-management support are most effective.
Electronic supplementary material
The online version of this article (doi:10.1186/1472-6963-14-356) contains supplementary material, which is available to authorized users.
doi:10.1186/1472-6963-14-356
PMCID: PMC4177163  PMID: 25164529
Self-management support interventions; Long-term conditions; Health outcomes; Quality of life; Health care utilization; Hospitalizations; Costs; Cost-effectiveness; Systematic review; Meta-analysis
10.  MAXimising Involvement in MUltiMorbidity (MAXIMUM) in primary care: protocol for an observation and interview study of patients, GPs and other care providers to identify ways of reducing patient safety failures 
BMJ Open  2014;4(8):e005493.
Introduction
Increasing numbers of older people are living with multiple long-term health conditions but global healthcare systems and clinical guidelines have traditionally focused on the management of single conditions. Having two or more long-term conditions, or ‘multimorbidity’, is associated with a range of adverse consequences and poor outcomes and could put patients at increased risk of safety failures. Traditionally, most research into patient safety failures has explored hospital or inpatient settings. Much less is known about patient safety failures in primary care. Our core aims are to understand the mechanisms by which multimorbidity leads to safety failures, to explore the different ways in which patients and services respond (or fail to respond), and to identify opportunities for intervention.
Methods and analysis
We plan to undertake an applied ethnographic study of patients with multimorbidity. Patients’ interactions and environments, relevant to their healthcare, will be studied through observations, diary methods and semistructured interviews. A framework, based on previous studies, will be used to organise the collection and analysis of field notes, observations and other qualitative data. This framework includes the domains: access breakdowns, communication breakdowns, continuity of care errors, relationship breakdowns and technical errors.
Ethics and dissemination
Ethical approval was received from the National Health Service Research Ethics Committee for Wales. An individual case study approach is likely to be most fruitful for exploring the mechanisms by which multimorbidity leads to safety failures. A longitudinal and multiperspective approach will allow for the constant comparison of patient, carer and healthcare worker expectations and experiences related to the provision, integration and management of complex care. This data will be used to explore ways of engaging patients and carers more in their own care using shared decision-making, patient empowerment or other relevant models.
doi:10.1136/bmjopen-2014-005493
PMCID: PMC4139641  PMID: 25138807
QUALITATIVE RESEARCH
11.  Cost-Effectiveness of Collaborative Care for Depression in UK Primary Care: Economic Evaluation of a Randomised Controlled Trial (CADET) 
PLoS ONE  2014;9(8):e104225.
Background
Collaborative care is an effective treatment for the management of depression but evidence on its cost-effectiveness in the UK is lacking.
Aims
To assess the cost-effectiveness of collaborative care in a UK primary care setting.
Methods
An economic evaluation alongside a multi-centre cluster randomised controlled trial comparing collaborative care with usual primary care for adults with depression (n = 581). Costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICER) were calculated over a 12-month follow-up, from the perspective of the UK National Health Service and Personal Social Services (i.e. Third Party Payer). Sensitivity analyses are reported, and uncertainty is presented using the cost-effectiveness acceptability curve (CEAC) and the cost-effectiveness plane.
Results
The collaborative care intervention had a mean cost of £272.50 per participant. Health and social care service use, excluding collaborative care, indicated a similar profile of resource use between collaborative care and usual care participants. Collaborative care offered a mean incremental gain of 0.02 (95% CI: –0.02, 0.06) quality-adjusted life-years over 12 months, at a mean incremental cost of £270.72 (95% CI: –202.98, 886.04), and resulted in an estimated mean cost per QALY of £14,248. Where costs associated with informal care are considered in sensitivity analyses collaborative care is expected to be less costly and more effective, thereby dominating treatment as usual.
Conclusion
Collaborative care offers health gains at a relatively low cost, and is cost-effective compared with usual care against a decision-maker willingness to pay threshold of £20,000 per QALY gained. Results here support the commissioning of collaborative care in a UK primary care setting.
doi:10.1371/journal.pone.0104225
PMCID: PMC4133193  PMID: 25121991
12.  Obsessive Compulsive Treatment Efficacy Trial (OCTET) comparing the clinical and cost effectiveness of self-managed therapies: study protocol for a randomised controlled trial 
Trials  2014;15:278.
Background
UK National Institute of Health and Clinical Excellence guidelines for obsessive compulsive disorder (OCD) specify recommendations for the treatment and management of OCD using a stepped care approach. Steps three to six of this model recommend treatment options for people with OCD that range from low-intensity guided self-help (GSH) to more intensive psychological and pharmacological interventions. Cognitive behavioural therapy (CBT), including exposure and response prevention, is the recommended psychological treatment. However, whilst there is some preliminary evidence that self-managed therapy packages for OCD can be effective, a more robust evidence base of their clinical and cost effectiveness and acceptability is required.
Methods/Design
Our proposed study will test two different self-help treatments for OCD: 1) computerised CBT (cCBT) using OCFighter, an internet-delivered OCD treatment package; and 2) GSH using a book. Both treatments will be accompanied by email or telephone support from a mental health professional. We will evaluate the effectiveness, cost and patient and health professional acceptability of the treatments.
Discussion
This study will provide more robust evidence of efficacy, cost effectiveness and acceptability of self-help treatments for OCD. If cCBT and/or GSH prove effective, it will provide additional, more accessible treatment options for people with OCD.
Trial registration
Current Controlled Trials: ISRCTN73535163. Date of registration: 5 April 2011
doi:10.1186/1745-6215-15-278
PMCID: PMC4226946  PMID: 25011730
Obsessive compulsive disorder; Guided self-help; Computerised cognitive behaviour therapy; Cognitive behaviour therapy; Exposure and response prevention
13.  Cost-effectiveness of telecare for people with social care needs: the Whole Systems Demonstrator cluster randomised trial 
Age and Ageing  2014;43(6):794-800.
Purpose of the study: to examine the costs and cost-effectiveness of ‘second-generation’ telecare, in addition to standard support and care that could include ‘first-generation’ forms of telecare, compared with standard support and care that could include ‘first-generation’ forms of telecare.
Design and methods: a pragmatic cluster-randomised controlled trial with nested economic evaluation. A total of 2,600 people with social care needs participated in a trial of community-based telecare in three English local authority areas. In the Whole Systems Demonstrator Telecare Questionnaire Study, 550 participants were randomised to intervention and 639 to control. Participants who were offered the telecare intervention received a package of equipment and monitoring services for 12 months, additional to their standard health and social care services. The control group received usual health and social care.
Primary outcome measure: incremental cost per quality-adjusted life year (QALY) gained. The analyses took a health and social care perspective.
Results: cost per additional QALY was £297,000. Cost-effectiveness acceptability curves indicated that the probability of cost-effectiveness at a willingness-to-pay of £30,000 per QALY gained was only 16%. Sensitivity analyses combining variations in equipment price and support cost parameters yielded a cost-effectiveness ratio of £161,000 per QALY.
Implications: while QALY gain in the intervention group was similar to that for controls, social and health services costs were higher. Second-generation telecare did not appear to be a cost-effective addition to usual care, assuming a commonly accepted willingness to pay for QALYs.
Trial registration number: ISRCTN 43002091.
doi:10.1093/ageing/afu067
PMCID: PMC4204660  PMID: 24950690
telecare; economic evaluation; social care; older people
14.  Depression and anxiety predict health-related quality of life in chronic obstructive pulmonary disease: systematic review and meta-analysis 
Background
The causal association between depression, anxiety, and health-related quality of life (HRQoL) in chronic obstructive pulmonary disease (COPD) is unclear. We therefore conducted a systematic review of prospective cohort studies that measured depression, anxiety, and HRQoL in COPD.
Methods
Electronic databases (Medline, Embase, Cumulative Index to Nursing and Allied Health Literature [CINAHL], British Nursing Index and Archive, PsycINFO and Cochrane database) were searched from inception to June 18, 2013. Studies were eligible for inclusion if they: used a nonexperimental prospective cohort design; included patients with a diagnosis of COPD confirmed by spirometry; and used validated measures of depression, anxiety, and HRQoL. Data were extracted and pooled using random effects models.
Results
Six studies were included in the systematic review; of these, three were included in the meta-analysis for depression and two were included for the meta-analysis for anxiety. Depression was significantly correlated with HRQoL at 1-year follow-up (pooled r=0.48, 95% confidence interval 0.37–0.57, P<0.001). Anxiety was also significantly correlated with HRQoL at 1-year follow-up (pooled r=0.36, 95% confidence interval 0.23–0.48, P<0.001).
Conclusion
Anxiety and depression predict HRQoL in COPD. However, this longitudinal analysis does not show cause and effect relationships between depression and anxiety and future HRQoL. Future studies should identify psychological predictors of poor HRQoL in well designed prospective cohorts with a view to isolating the mediating role played by anxiety disorder and depression.
doi:10.2147/COPD.S58136
PMCID: PMC4035108  PMID: 24876770
long-term conditions; COPD; quality of life; panic
15.  Benefits of Aldosterone Receptor Antagonism in Chronic Kidney Disease (BARACK D) trial–a multi-centre, prospective, randomised, open, blinded end-point, 36-month study of 2,616 patients within primary care with stage 3b chronic kidney disease to compare the efficacy of spironolactone 25 mg once daily in addition to routine care on mortality and cardiovascular outcomes versus routine care alone: study protocol for a randomized controlled trial 
Trials  2014;15:160.
Background
Chronic kidney disease (CKD) is common and increasing in prevalence. Cardiovascular disease (CVD) is a major cause of morbidity and death in CKD, though of a different phenotype to the general CVD population. Few therapies have proved effective in modifying the increased CVD risk or rate of renal decline in CKD. There are accumulating data that aldosterone receptor antagonists (ARA) may offer cardio-protection and delay renal impairment in patients with the CV phenotype in CKD. The use of ARA in CKD has therefore been increasingly advocated. However, no large study of ARA with renal or CVD outcomes is underway.
Methods
The study is a prospective randomised open blinded endpoint (PROBE) trial set in primary care where patients will mainly be identified by their GPs or from existing CKD lists. They will be invited if they have been formally diagnosed with CKD stage 3b or there is evidence of stage 3b CKD from blood results (eGFR 30–44 mL/min/1.73 m2) and fulfil the other inclusion/exclusion criteria. Patients will be randomised to either spironolactone 25 mg once daily in addition to routine care or routine care alone and followed-up for 36 months.
Discussion
BARACK D is a PROBE trial to determine the effect of ARA on mortality and cardiovascular outcomes (onset or progression of CVD) in patients with stage 3b CKD.
Trial registration
EudraCT: 2012-002672-13
ISRTN: ISRCTN44522369
doi:10.1186/1745-6215-15-160
PMCID: PMC4113231  PMID: 24886488
Cardiovascular disease; Chronic kidney disease; CKD mortality; CKD aldosterone receptor antagonist
16.  Qualitative Meta-Synthesis of User Experience of Computerised Therapy for Depression and Anxiety 
PLoS ONE  2014;9(1):e84323.
Objective
Computerised therapies play an integral role in efforts to improve access to psychological treatment for patients with depression and anxiety. However, despite recognised problems with uptake, there has been a lack of investigation into the barriers and facilitators of engagement. We aimed to systematically review and synthesise findings from qualitative studies of computerised therapies, in order to identify factors impacting on engagement.
Method
Systematic review and meta-synthesis of qualitative studies of user experiences of computer delivered therapy for depression and/or anxiety.
Results
8 studies were included in the review. All except one were of desktop based cognitive behavioural treatments. Black and minority ethnic and older participants were underrepresented, and only one study addressed users with a co-morbid physical health problem. Through synthesis, we identified two key overarching concepts, regarding the need for treatments to be sensitive to the individual, and the dialectal nature of user experience, with different degrees of support and anonymity experienced as both positive and negative. We propose that these factors can be conceptually understood as the ‘non-specific’ or ‘common’ factors of computerised therapy, analogous to but distinct from the common factors of traditional face-to-face therapies.
Conclusion
Experience of computerised therapy could be improved through personalisation and sensitisation of content to individual users, recognising the need for users to experience a sense of ‘self’ in the treatment which is currently absent. Exploiting the common factors of computerised therapy, through enhancing perceived connection and collaboration, could offer a way of reconciling tensions due to the dialectal nature of user experience. Future research should explore whether the findings are generalisable to other patient groups, to other delivery formats (such as mobile technology) and other treatment modalities beyond cognitive behaviour therapy. The proposed model could aid the development of enhancements to current packages to improve uptake and support engagement.
doi:10.1371/journal.pone.0084323
PMCID: PMC3894944  PMID: 24465404
17.  Telephone based self-management support by ‘lay health workers’ and ‘peer support workers’ to prevent and manage vascular diseases: a systematic review and meta-analysis 
Background
Improved prevention and management of vascular disease is a global priority. Non-health care professionals (such as, ‘lay health workers’ and ‘peer support workers’) are increasingly being used to offer telephone support alongside that offered by conventional services, to reach disadvantaged populations and to provide more efficient delivery of care. However, questions remain over the impact of such interventions, particularly on a wider range of vascular related conditions (such as, chronic kidney disease), and it is unclear how different types of telephone support impact on outcome. This study assessed the evidence on the effectiveness and cost-effectiveness of telephone self-management interventions led by ‘lay health workers’ and ‘peer support workers’ for patients with vascular disease and long-term conditions associated with vascular disease.
Methods
Systematic review of randomised controlled trials. Three electronic databases were searched. Two authors independently extracted data according to the Cochrane risk of bias tool. Random effects meta-analysis was used to pool outcome measures.
Results
Ten studies were included, primarily based in community settings in the United States; with participants who had diabetes; and used ‘peer support workers’ that shared characteristics with patients. The included studies were generally rated at risk of bias, as many methodological criteria were rated as ‘unclear’ because of a lack of information.
Overall, peer telephone support was associated with small but significant improvements in self-management behaviour (SMD = 0.19, 95% CI 0.05 to 0.33, I2 = 20.4%) and significant reductions in HbA1c level (SMD = -0.26, 95% CI −0.41 to −0.11, I2 = 47.6%). There was no significant effect on mental health quality of life (SMD = 0.03, 95% CI −0.12 to 0.18, I2 = 0%). Data on health care utilisation were very limited and no studies reported cost effectiveness analyses.
Conclusions
Positive effects were found for telephone self-management interventions via ‘lay workers’ and ‘peer support workers’ for patients on diabetes control and self-management outcomes, but the overall evidence base was limited in scope and quality. Well designed trials assessing non-healthcare professional delivered telephone support for the prevention and management of vascular disease are needed to identify the content of effective components on health outcomes, and to assess cost effectiveness, to determine if such interventions are potentially useful alternatives to professionally delivered care.
doi:10.1186/1472-6963-13-533
PMCID: PMC3880982  PMID: 24370214
Self-management support; Chronic care; Non-healthcare professional; Peer; Lay; Telephone; Vascular disease; Chronic kidney disease; Prevention; Management; Patients; Social disadvantage; Health services research; Randomised controlled trial; Review; Meta-analysis
18.  Development of a Multimorbidity Illness Perceptions Scale (MULTIPleS) 
PLoS ONE  2013;8(12):e81852.
Background
Illness perceptions are beliefs about the cause, nature and management of illness, which enable patients to make sense of their conditions. These perceptions can predict adjustment and quality of life in patients with single conditions. However, multimorbidity (i.e. patients with multiple long-term conditions) is increasingly prevalent and a key challenge for future health care delivery. The objective of this research was to develop a valid and reliable measure of illness perceptions for multimorbid patients.
Methods
Candidate items were derived from previous qualitative research with multimorbid patients. Questionnaires were posted to 1500 patients with two or more exemplar long-term conditions (depression, diabetes, osteoarthritis, coronary heart disease and chronic obstructive pulmonary disease). Data were analysed using factor analysis and Rasch analysis. Rasch analysis is a modern psychometric technique for deriving unidimensional and intervally-scaled questionnaires.
Results
Questionnaires from 490 eligible patients (32.6% response) were returned. Exploratory factor analysis revealed five potential subscales ‘Emotional representations’, ‘Treatment burden’, ‘Prioritising conditions’, ‘Causal links’ and ‘Activity limitations’. Rasch analysis led to further item reduction and the generation of a summary scale comprising of items from all scales. All scales were unidimensional and free from differential item functioning or local independence of items. All scales were reliable, but for each subscale there were a number of patients who scored at the floor of the scale.
Conclusions
The MULTIPleS measure consists of five individual subscales and a 22-item summary scale that measures the perceived impact of multimorbidity. All scales showed good fit to the Rasch model and preliminary evidence of reliability and validity. A number of patients scored at floor of each subscale, which may reflect variation in the perception of multimorbidity. The MULTIPleS measure will facilitate research into the impact of illness perceptions on adjustment, clinical outcomes, quality of life, and costs in patients with multimorbidity.
doi:10.1371/journal.pone.0081852
PMCID: PMC3869652  PMID: 24376504
22.  Patient empowerment in long-term conditions: development and preliminary testing of a new measure 
Background
Patient empowerment is viewed by policy makers and health care practitioners as a mechanism to help patients with long-term conditions better manage their health and achieve better outcomes. However, assessing the role of empowerment is dependent on effective measures of empowerment. Although many measures of empowerment exist, no measure has been developed specifically for patients with long-term conditions in the primary care setting. This study presents preliminary data on the development and validation of such a measure.
Methods
We conducted two empirical studies. Study one was an interview study to understand empowerment from the perspective of patients living with long-term conditions. Qualitative analysis identified dimensions of empowerment, and the qualitative data were used to generate items relating to these dimensions. Study two was a cross-sectional postal study involving patients with different types of long-term conditions recruited from general practices. The survey was conducted to test and validate our new measure of empowerment. Factor analysis and regression were performed to test scale structure, internal consistency and construct validity.
Results
Sixteen predominately elderly patients with different types of long-term conditions described empowerment in terms of 5 dimensions (identity, knowledge and understanding, personal control, personal decision-making, and enabling other patients). One hundred and ninety seven survey responses were received from mainly older white females, with relatively low levels of formal education, with the majority retired from paid work. Almost half of the sample reported cardiovascular, joint or diabetes long-term conditions. Factor analysis identified a three factor solution (positive attitude and sense of control, knowledge and confidence in decision making and enabling others), although the structure lacked clarity. A total empowerment score across all items showed acceptable levels of internal consistency and relationships with other measures were generally supportive of its construct validity.
Conclusion
Initial analyses suggest that the new empowerment measure meets basic psychometric criteria. Reasons concerning the failure to confirm the hypothesized factor structure are discussed alongside further developments of the scale.
doi:10.1186/1472-6963-13-263
PMCID: PMC3725177  PMID: 23835131
Patient empowerment; Long-term conditions; Primary care; Patients’ perspectives; Semi-structured interviews; Measurement; Scale development; Psychometrics; Health outcomes
23.  Implementation of self management support for long term conditions in routine primary care settings: cluster randomised controlled trial 
Objective To determine the effectiveness of an intervention to enhance self management support for patients with chronic conditions in UK primary care.
Design Pragmatic, two arm, cluster randomised controlled trial.
Setting General practices, serving a population in northwest England with high levels of deprivation.
Participants 5599 patients with a diagnosis of diabetes (n=2546), chronic obstructive pulmonary disease (n=1634), and irritable bowel syndrome (n=1419) from 43 practices (19 intervention and 22 control practices).
Intervention Practice level training in a whole systems approach to self management support. Practices were trained to use a range of resources: a tool to assess the support needs of patients, guidebooks on self management, and a web based directory of local self management resources. Training facilitators were employed by the health management organisation.
Main outcome measures Primary outcomes were shared decision making, self efficacy, and generic health related quality of life measured at 12 months. Secondary outcomes were general health, social or role limitations, energy and vitality, psychological wellbeing, self care activity, and enablement.
Results We randomised 44 practices and recruited 5599 patients, representing 43% of the eligible population on the practice lists. 4533 patients (81.0%) completed the six month follow-up and 4076 (72.8%) the 12 month follow-up. No statistically significant differences were found between patients attending trained practices and those attending control practices on any of the primary or secondary outcomes. All effect size estimates were well below the prespecified threshold of clinically important difference.
Conclusions An intervention to enhance self management support in routine primary care did not add noticeable value to existing care for long term conditions. The active components required for effective self management support need to be better understood, both within primary care and in patients’ everyday lives.
Trial registration Current Controlled Trials ISRCTN90940049.
doi:10.1136/bmj.f2882
PMCID: PMC3652644  PMID: 23670660
24.  Update on the collaborative interventions for circulation and depression (COINCIDE) trial: changes to planned methodology of a cluster randomized controlled trial of collaborative care for depression in people with diabetes and/or coronary heart disease 
Trials  2013;14:136.
Background
The COINCIDE trial aims to evaluate the effectiveness and cost-effectiveness of a collaborative care intervention for depression in people with diabetes and/or coronary heart disease attending English general practices.
Design
This update details changes to the cluster and patient recruitment strategy for the COINCIDE study. The original protocol was published in Trials (http://www.trialsjournal.com/content/pdf/1745-6215-13-139.pdf). Modifications were made to the recruitment targets in response to lower-than-expected patient recruitment at the first ten general practices recruited into the study. In order to boost patient numbers and retain statistical power, the number of general practices recruited was increased from 30 to 36. Follow-up period was shortened from 6 months to 4 months to ensure that patients recruited to the trial could be followed up by the end of the study.
Results
Patient recruitment began on the 01/05/2012 and is planned to be completed by the 30/04/2013. Recruitment for general practices was completed on 31/10/2012, by which time the target of 36 practices had been recruited. The main trial results will be published in a peer-reviewed journal.
Conclusion
The data from the trial will provide evidence on the effectiveness and cost-effectiveness of collaborative care for depression in people with diabetes and/or coronary heart disease.
Trial registration
Trial registration number: ISRCTN80309252
doi:10.1186/1745-6215-14-136
PMCID: PMC3660180  PMID: 23663556
Depression; Diabetes; Coronary heart disease; Primary care; Collaborative care
25.  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.
Background
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).
Conclusions
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.
doi:10.1371/journal.pone.0060532
PMCID: PMC3621386  PMID: 23585837

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