A community-based group-guided self-help intervention for low mood and stress: study protocol for a randomized controlled trial

<br>Background: Depression is a mental health condition which affects millions of people each year, with worldwide rates increasing. Cognitive behavioral therapy (CBT) is recommended in the National Institute for Health and Clinical Excellence (NICE) guidelines for the treatment of depression. However, waiting lists can cause delays for face-to-face therapy. Also a proportion of people decline to present for help through the health service – the so-called treatment gap. Self-referral to CBT using community-based group interventions delivered by a voluntary sector organization may serve to resolve this problem. The aim of this randomized controlled trial (RCT) is to determine the efficacy of such a guided CBT self-help course, the ‘Living Life to the Full’ (LLTTF) classes delivered by the charity Action on Depression (AOD). The primary outcome is level of depression at 6 months assessed using the patient health questionnaire-9 (PHQ9) depression scale. Secondary measures include levels of anxiety and social functioning.</br> <br>Methods/design: Participants with symptoms of low mood will be recruited from the community through newspaper adverts and also via the AOD website. Participants will receive either immediate or delayed access to guided CBT self-help classes - the eight session LLTTF course. The primary endpoint will be at 6 months at which point the delayed group will be offered the intervention. Levels of depression, anxiety and social functioning will be assessed and an economic analysis will be carried out.</br> <br>Discussion: This RCT will test whether the LLTTF intervention is effective and/or cost-effective. If the LLTTF community-based classes are found to be cost effective, they may be helpful as both an intervention for those already seeking care in the health service, as well as those seeking help outside that setting, widening access to psychological therapy.</br&gt

Evaluating methodological quality of Prognostic models Including Patient-reported HeAlth outcomes in oncologY (EPIPHANY): A systematic review protocol

Introduction While there is mounting evidence of the independent prognostic value of patient-reported outcomes (PROs) for overall survival (OS) in patients with cancer, it is known that the conduct of these studies may hold a number of methodological challenges. The aim of this systematic review is to evaluate the quality of published studies in this research area, in order to identify methodological and statistical issues deserving special attention and to also possibly provide evidence-based recommendations. Methods and analysis An electronic search strategy will be performed in PubMed to identify studies developing or validating a prognostic model which includes PROs as predictors. Two reviewers will independently be involved in data collection using a predefined and standardised data extraction form including information related to study characteristics, PROs measures used and multivariable prognostic models. Studies selection will be reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, with data extraction form using fields from the Critical Appraisal and Data Extraction for Systematic Reviews of Prediction Modelling Studies (CHARMS) checklist for multivariable models. Methodological quality assessment will also be performed and will be based on prespecified domains of the CHARMS checklist. As a substantial heterogeneity of included studies is expected, a narrative evidence synthesis will also be provided. Ethics and dissemination Given that this systematic review will use only published data, ethical permissions will not be required. Findings from this review will be published in peer-reviewed scientific journals and presented at major international conferences. We anticipate that this review will contribute to identify key areas of improvement for conducting and reporting prognostic factor analyses with PROs in oncology and will lay the groundwork for developing future evidence-based recommendations in this area of research. Prospero registration number CRD42018099160

Characteristics of successful interventions to reduce turnover and increase retention of early career nurses: a systematic review

Background nurse shortages have been identified as central to workforce issues in healthcare systems globally and although interventions to increase the nursing workforce have been implemented, nurses leaving their roles, particularly in the first year after qualification, present a significant barrier to building the nurse workforce. Objective to evaluate the characteristics of successful interventions to promote retention and reduce turnover of early career nurses. Design this is a systematic review Data sources Online databases including Academic Search Complete, Medline, Health Policy reference Centre, EMBASE, Psychinfo, CINAHL and the Cochran Library were searched to identify relevant publications in English published between 2001 and April 2018. Studies included evaluated an intervention to increase retention or reduce turnover and used turnover or retention figures as a measure. Review methods The review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. Studies were quality-assessed using the Joanna Briggs Institute Critical Appraisal tools for Quasi Experimental and Randomised Controlled Trials. Retention/turnover data were used to guide the comparison between studies and appropriate measures of central tendency and dispersion were calculated and presented, based on the normality of the data. Results A total of 11, 656 papers were identified, of which 53 were eligible studies. A wide variety of interventions and components within those interventions were identified to improve nurse retention. Promising interventions appear to be either internship/residency programmes or orientation/transition to practice programmes, lasting between 27-52 weeks, with a teaching and preceptor and mentor component. Conclusions Methodological issues impacted on the extent to which conclusions could be drawn, even though a large number of studies were identified. Future research should focus on standardising the reporting of interventions and outcome measures used to evaluate these interventions and carrying out further research with rigorous methodology. Clinical practice areas are recommended to assess their current interventions against the identified criteria to guide development of their effectiveness. Evaluations of cost-effectiveness are considered an important next step to maximise return on investment

The Diabetes Manual trial protocol – a cluster randomized controlled trial of a self-management intervention for type 2 diabetes [ISRCTN06315411]

Background The Diabetes Manual is a type 2 diabetes self-management programme based upon the clinically effective 'Heart Manual'. The 12 week programme is a complex intervention theoretically underpinned by self-efficacy theory. It is a one to one intervention meeting United Kingdom requirements for structured diabetes-education and is delivered within routine primary care. Methods/design In a two-group cluster randomized controlled trial, GP practices are allocated by computer minimisation to an intervention group or a six-month deferred intervention group. We aim to recruit 250 participants from 50 practices across central England. Eligibility criteria are adults able to undertake the programme with type 2 diabetes, not taking insulin, with HbA1c over 8% (first 12 months) and following an agreed protocol change over 7% (months 13 to 18). Following randomisation, intervention nurses receive two-day training and delivered the Diabetes Manual programme to participants. Deferred intervention nurses receive the training following six-month follow-up. Primary outcome is HbA1c with total and HDL cholesterol; blood pressure, body mass index; self-efficacy and quality of life as additional outcomes. Primary analysis is between-group HbA1c differences at 6 months powered to give 80% power to detect a difference in HbA1c of 0.6%. A 12 month cohort analysis will assess maintenance of effect and assess relationship between self-efficacy and outcomes, and a qualitative study is running alongside. Discussion This trial incorporates educational and psychological diabetes interventions into a single programme and assesses both clinical and psychosocial outcomes. The trial will increase our understanding of intervention transferability between conditions, those diabetes related health behaviours that are more or less susceptible to change through efficacy enhancing mechanisms and how this impacts on clinical outcomes

Physiotherapy versus placebo or no intervention in Parkinson's disease

Background: Despite medical therapies and surgical interventions for Parkinson's disease (PD), patients develop progressive disability. Physiotherapy aims to maximise functional ability and minimise secondary complications through movement rehabilitation within a context of education and support for the whole person. The overall aim is to optimise independence, safety, and well-being, thereby enhancing quality of life.  Objectives: To assess the effectiveness of physiotherapy intervention compared with no intervention in patients with PD.  Search methods: We identified relevant trials by conducting electronic searches of numerous literature databases (e.g. MEDLINE, EMBASE) and trial registers, and by handsearching major journals, abstract books, conference proceedings, and reference lists of retrieved publications. The literature search included trials published up to the end of January 2012.  Selection criteria: Randomised controlled trials of physiotherapy intervention versus no physiotherapy intervention in patients with PD.  Data collection and analysis: Two review authors independently extracted data from each article. We used standard meta-analysis methods to assess the effectiveness of physiotherapy intervention compared with no physiotherapy intervention. Trials were classified into the following intervention comparisons: general physiotherapy, exercise, treadmill training, cueing, dance, and martial arts. We used tests for heterogeneity to assess for differences in treatment effect across these different physiotherapy interventions.  Main results: We identified 39 trials with 1827 participants. We considered the trials to be at a mixed risk of bias as the result of unreported allocation concealment and probable detection bias. Compared with no intervention, physiotherapy significantly improved the gait outcomes of speed (mean difference 0.04 m/s, 95% confidence interval (CI) 0.02 to 0.06, P = 0.0002); two- or six-minute walk test (13.37 m, 95% CI 0.55 to 26.20, P = 0.04) and Freezing of Gait questionnaire (-1.41, 95% CI -2.63 to -0.19, P = 0.02); functional mobility and balance outcomes of Timed Up & Go test (-0.63 s, 95% CI -1.05 to -0.21, P = 0.003), Functional Reach Test (2.16 cm, 95% CI 0.89 to 3.43, P = 0.0008), and Berg Balance Scale (3.71 points, 95% CI 2.30 to 5.11, P < 0.00001); and clinician-rated disability using the Unified Parkinson’s Disease Rating Scale (UPDRS) (total -6.15 points, 95% CI-8.57 to -3.73, P < 0.00001; activities of daily living: -1.36, 95% CI -2.41 to -0.30, P = 0.01; and motor: -5.01, 95% CI -6.30 to -3.72, P < 0.00001). No difference between arms was noted in falls (Falls Efficacy Scale: -1.91 points, 95% CI -4.76 to 0.94, P = 0.19) or patient-rated quality of life (PDQ-39 Summary Index: -0.38 points, 95% CI -2.58 to 1.81, P = 0.73). One study reported that adverse events were rare; no other studies reported data on this outcome. Indirect comparisons of the different physiotherapy interventions revealed no evidence that the treatment effect differed across physiotherapy interventions for any of the outcomes assessed.  Authors' conclusions: Benefit for physiotherapy was found in most outcomes over the short term (i.e. < 3 months) but was significant only for speed, two- or six-minute walk test, Freezing of Gait questionnaire, Timed Up & Go, Functional Reach Test, Berg Balance Scale, and clinician-rated UPDRS. Most of the observed differences between treatments were small. However, for some outcomes (e.g. speed, Berg Balance Scale, UPDRS), the differences observed were at, or approaching, what are considered minimal clinically important changes. These benefits should be interpreted with caution because the quality of most of the included trials was not high. Variation in measurements of outcome between studies meant that our analyses include a small proportion of the participants recruited.  This review illustrates that a wide range of approaches are employed by physiotherapists to treat patients with PD. However, no evidence of differences in treatment effect was noted between the different types of physiotherapy interventions being used, although this was based on indirect comparisons. A consensus menu of 'best practice' physiotherapy is needed, as are large, well-designed randomised controlled trials undertaken to demonstrate the longer-term efficacy and cost-effectiveness of 'best practice' physiotherapy in PD

Factors influencing utilisation of ‘free-standing’ and ‘alongside’ midwifery units for low-risk births in England: a mixed-methods study

Background Midwifery-led units (MUs) are recommended for ‘low-risk’ births by the National Institute for Health and Care Excellence but according to the National Audit Office were not available in one-quarter of trusts in England in 2013 and, when available, were used by only a minority of the low-risk women for whom they should be suitable. This study explores why. Objectives To map the provision of MUs in England and explore barriers to and facilitators of their development and use; and to ascertain stakeholder views of interventions to address these barriers and facilitators. Design Mixed methods – first, MU access and utilisation across England was mapped; second, local media coverage of the closure of free-standing midwifery units (FMUs) were analysed; third, case studies were undertaken in six sites to explore the barriers and facilitators that have an impact on the development of MUs; and, fourth, by convening a stakeholder workshop, interventions to address the barriers and facilitators were discussed. Setting English NHS maternity services. Participants All trusts with maternity services. Interventions Establishing MUs. Main outcome measures Numbers and types of MUs and utilisation of MUs. Results Births in MUs across England have nearly tripled since 2011, to 15% of all births. However, this increase has occurred almost exclusively in alongside units, numbers of which have doubled. Births in FMUs have stayed the same and these units are more susceptible to closure. One-quarter of trusts in England have no MUs; in those that do, nearly all MUs are underutilised. The study findings indicate that most trust managers, senior midwifery managers and obstetricians do not regard their MU provision as being as important as their obstetric-led unit provision and therefore it does not get embedded as an equal and parallel component in the trust’s overall maternity package of care. The analysis illuminates how provision and utilisation are influenced by a complex range of factors, including the medicalisation of childbirth, financial constraints and institutional norms protecting the status quo. Limitations When undertaking the case studies, we were unable to achieve representativeness across social class in the women’s focus groups and struggled to recruit finance directors for individual interviews. This may affect the transferability of our findings. Conclusions Although there has been an increase in the numbers and utilisation of MUs since 2011, significant obstacles remain to MUs reaching their full potential, especially FMUs. This includes the capacity and willingness of providers to address women’s information needs. If these remain unaddressed at commissioner and provider level, childbearing women’s access to MUs will continue to be restricted. Future work Work is needed on optimum approaches to improve decision-makers’ understanding and use of clinical and economic evidence in service design. Increasing women’s access to information about MUs requires further studies of professionals’ understanding and communication of evidence. The role of FMUs in the context of rural populations needs further evaluation to take into account user and community impact. Funding This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 8, No. 12. See the NIHR Journals Library website for further project information