Rachel Winder

Facilitated physical activity as a treatment for depressed adults: randomised controlled trial

Objective To investigate the effectiveness of facilitated physical activity as an adjunctive treatment for adults with depression presenting in primary care. Design Pragmatic, multicentre, two arm parallel randomised controlled trial. Setting General practices in Bristol and Exeter. Participants 361 adults aged 18-69 who had recently consulted their general practitioner with symptoms of depression. All those randomised had a diagnosis of an episode of depression as assessed by the clinical interview schedule-revised and a Beck depression inventory score of 14 or more. Interventions In addition to usual care, intervention participants were offered up to three face to face sessions and 10 telephone calls with a trained physical activity facilitator over eight months. The intervention was based on theory and aimed to provide individually tailored support and encouragement to engage in physical activity. Main outcome measures The primary outcome was self reported symptoms of depression, assessed with the Beck depression inventory at four months post-randomisation. Secondary outcomes included use of antidepressants and physical activity at the four, eight, and 12 month follow-up points, and symptoms of depression at eight and 12 month follow-up. Results There was no evidence that participants offered the physical activity intervention reported improvement in mood by the four month follow-up point compared with those in the usual care group; adjusted between group difference in mean Beck depression inventory score −0.54 (95% confidence interval −3.06 to 1.99; P=0.68). Similarly, there was no evidence that the intervention group reported a change in mood by the eight and 12 month follow-up points. Nor was there evidence that the intervention reduced antidepressant use compared with usual care (adjusted odds ratio 0.63, 95% confidence interval 0.19 to 2.06; P=0.44) over the duration of the trial. However, participants allocated to the intervention group reported more physical activity during the follow-up period than those allocated to the usual care group (adjusted odds ratio 2.27, 95% confidence interval 1.32 to 3.89; P=0.003). Conclusions The addition of a facilitated physical activity intervention to usual care did not improve depression outcome or reduce use of antidepressants compared with usual care alone. Trial registration Current Controlled Trials ISRCTN16900744.

Fuels for memory : The role of oxygen and glucose in memory enhancement

Abstract Recent studies indicate that some aspects of memory can be enhanced by the administration of oxygen or glucose. Considering the dependency of glucose metabolism upon oxygen supply, the present study predicted that administering a combination of 100% oxygen with glucose would have greater memory-enhancing effects than when either substance was administered alone. In a placebo-controlled study, 104 healthy adults were given a glucose or placebo drink, and inhaled 100% oxygen or air for 1 min, before carrying out a number of everyday memory tasks designed to measure short-term and long-term memory. Results showed support for the enhancing effects of oxygen (but not for glucose) on delayed recall. These findings are discussed in relation to the possible cholinergic properties of oxygen and glucose and the implications for their clinical use.

A pragmatic randomised controlled trial to evaluate the cost-effectiveness of a physical activity intervention as a treatment for depression: the treating depression with physical activity (TREAD) trial.

OBJECTIVE The TREAting Depression with physical activity (TREAD) study investigated the cost-effectiveness of a physical activity intervention, in addition to usual general practitioner care, as a treatment for people with depression. DESIGN An individually randomised, pragmatic, multicentre randomised controlled trial with follow-up at 4, 8 and 12 months. A subset of participants took part in a qualitative study that investigated the acceptability and perceived benefits of the intervention. SETTING General practices in the Bristol and Exeter areas. PARTICIPANTS Aged 18-69 years with an International Statistical Classification of Diseases and Related Health Problems, 10th Edition (ICD-10) diagnosis of depression and scoring ≥ 14 on the Beck Depression Inventory (BDI). Those who were unable to complete self-administered questionnaires in English, with medical contraindications to physical activity or with psychosis, bipolar disorder or serious drug abuse were excluded. INTERVENTIONS We devised an intervention designed to encourage choice and autonomy in the adoption of physical activity. It consisted of up to three face-to-face and ten telephone contacts delivered by a trained physical activity facilitator over an 8-month period. MAIN OUTCOME MEASURES The primary outcome was the BDI score measured at 4 months. Secondary outcomes included depressive symptoms over the 12 months and quality of life, antidepressant use and level of physical activity. RESULTS The study recruited 361 patients, with 182 randomised to the intervention arm and 179 to the usual care arm; there was 80% retention at the 4-month follow-up. The intervention group had a slightly lower BDI score at 4 months [-0.54, 95% confidence interval (CI) -3.06 to 1.99] but there was no evidence that the intervention improved outcome for depression. Neither was there any evidence to suggest a difference in the prescription of or self-reported use of antidepressants. However, the amount of physical activity undertaken by those who had received the intervention was increased (odds ratio 2.3, 95% CI 1.3 to 3.9) and was sustained beyond the end of the intervention. From a health-care perspective, the intervention group was more costly than the usual care group, with the cost of the intervention £220 per person on average. It is therefore extremely unlikely that the intervention is cost-effective as a treatment for depression using current willingness-to-pay thresholds. CONCLUSIONS This physical activity intervention is very unlikely to lead to any clinical benefit in terms of depressive symptoms or to be a cost-effective treatment for depression. Previous research has reported some benefit and there are three possible reasons for this discrepancy: first, even though the intervention increased self-reported physical activity, the increase in activity was not sufficiently large to lead to a measurable influence; second, only more vigorous activity might be of benefit; and third, previous studies had recruited individuals with a pre-existing commitment to physical activity. Future research is needed to identify and explain the mechanisms by which depression might be effectively treated, including, in particular, specific guidance on the optimum type, intensity and duration of physical activity required to produce a therapeutic effect. TRIAL REGISTRATION Current Controlled Trials ISRCTN16900744. FUNDING This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 16, No. 10. See the HTA programme website for further project information.

Much more medicine for the oldest old: trends in UK electronic clinical records

Background: the oldest old (85+) pose complex medical challenges. Both underdiagnosis and overdiagnosis are claimed in this group. Objective: to estimate diagnosis, prescribing and hospital admission prevalence from 2003/4 to 2011/12, to monitor trends in medicalisation. Design and setting: observational study of Clinical Practice Research Datalink (CPRD) electronic medical records from general practice populations (eligible; n = 27,109) with oversampling of the oldest old. Methods: we identified 18 common diseases and five geriatric syndromes (dizziness, incontinence, skin ulcers, falls and fractures) from Read codes. We counted medications prescribed ≥1 time in all quarters of studied years. Results: there were major increases in recorded prevalence of most conditions in the 85+ group, especially chronic kidney disease (stages 3–5: prevalence <1% rising to 36.4%). The proportions of the 85+ group with ≥3 conditions rose from 32.2 to 55.1% (27.1 to 35.1% in the 65–84 year group). Geriatric syndrome trends were less marked. In the 85+ age group the proportion receiving no chronically prescribed medications fell from 29.6 to 13.6%, while the proportion on ≥3 rose from 44.6 to 66.2%. The proportion of 85+ year olds with ≥1 hospital admissions per year rose from 27.6 to 35.4%. Conclusions: there has been a dramatic increase in the medicalisation of the oldest old, evident in increased diagnosis (likely partly due to better record keeping) but also increased prescribing and hospitalisation. Diagnostic trends especially for chronic kidney disease may raise concerns about overdiagnosis. These findings provide new urgency to questions about the appropriateness of multiple diagnostic labelling.

Development of an educational 'toolkit' for health professionals and their patients with prediabetes: the WAKEUP study (Ways of Addressing Knowledge Education and Understanding in Pre-diabetes).

Aims  To identify key messages about pre‐diabetes and to design, develop and pilot an educational toolkit to address the information needs of patients and health professionals.

Accessing out-of-hours care following implementation of the GMS contract: an observational study

BACKGROUND There is widespread concern that the quality of out-of-hours primary care for patients with complex needs may be at risk now that the new general medical services contract (GMS) has been implemented. AIM To explore changes in the use of out-of-hours services around the time of implementation of the new contract for patients with complex needs, using patients with cancer as an example. DESIGN OF STUDY Longitudinal observational study. SETTING Out-of-hours primary care provider covering Devon (adult population 900,000), UK. METHOD Two, 1-year periods corresponding to pre- (April 2003 to March 2004) and post-contract implementation (October 2004 to September 2005) were sampled. Call rates per 1000 of the adult population (age>or=16 years) were calculated for all calls (any cause) and cancer-related calls. Anonymised outcome and process measures data were extracted. RESULTS Although overall call rates per 1000 population had increased by 26% (185 pre-contract to 233 post-contract), the proportion of cancer-related calls remained relatively constant (2.08% versus 1.96%). Around half (56%) of these callers had advanced cancer needs (including palliative care). By post-contract, the time taken to triage had significantly increased (P<0.001). Although the proportions admitted to hospital or receiving a home visit remained constant, calls where a special message was sent by the out-of-hours clinician to the in-hours team had decreased (P<0.001). CONCLUSION The demand for out-of-hours care for patients with cancer did not alter disproportionately after implementation of the contract. While potential quality indicators (for example, hospital admissions, home visiting rates) remained constant, potentially adverse changes to triage time and communication between out-of-hours and in-hours clinicians were observed. Quality standards and provider databases require further refinement to capture elements of care relevant to patients with complex needs.

Physical activity as a treatment for depression: the TREAD randomised trial protocol

BackgroundDepression is one of the most common reasons for consulting a General Practitioner (GP) within the UK. Whilst antidepressants have been shown to be clinically effective, many patients and healthcare professionals would like to access other forms of treatment as an alternative or adjunct to drug therapy for depression. A recent systematic review presented some evidence that physical activity could offer one such option, although further investigation is needed to test its effectiveness within the context of the National Health Service.The aim of this paper is to describe the protocol for a randomised, controlled trial (RCT) designed to evaluate an intervention developed to increase physical activity as a treatment for depression within primary care.Methods/designThe TREAD study is a pragmatic, multi-centre, two-arm RCT which targets patients presenting with a new episode of depression. Patients were approached if they were aged 18-69, had recently consulted their GP for depression and, where appropriate, had been taking antidepressants for less than one month. Only those patients with a confirmed diagnosis of a depressive episode as assessed by the Clinical Interview Schedule-Revised (CIS-R), a Beck Depression Inventory (BDI) score of at least 14 and informed written consent were included in the study. Eligible patients were individually randomised to one of two treatment groups; usual GP care or usual GP care plus facilitated physical activity. The primary outcome of the trial is clinical symptoms of depression assessed using the BDI four months after randomisation. A number of secondary outcomes are also measured at the 4-, 8- and 12-month follow-up points including quality of life, attitude to and involvement in physical activity and antidepressant use/adherence. Outcomes will be analysed on an intention-to-treat (ITT) basis and will use linear and logistic regression models to compare treatments.DiscussionThe results of the trial will provide information about the effectiveness of physical activity as a treatment for depression. Given the current prevalence of depression and its associated economic burden, it is hoped that TREAD will provide a timely contribution to the evidence on treatment options for patients, clinicians and policy-makers.Trial registration: ISRCTN 16900744

Why do GPs exclude patients from participating in research? An exploration of adherence to and divergence from trial criteria

BACKGROUND The role of GPs in recruiting or excluding participants critically underpins the feasibility, external validity and generalizability of primary care research. A better understanding of this role is needed. AIM To investigate why GPs excluded potentially eligible participants from a large scale randomized controlled trial (RCT), to determine the proportion of patients excluded on account of trial eligibility compared with other reasons, and to explore the impact of such exclusions on the management and generalizability of RCTs. DESIGN AND SETTING Secondary analysis of data from the CoBalT study, a multi-centre general-practice-based RCT investigating cognitive behavioural therapy as an adjunct to pharmacotherapy for treatment-resistant depression. METHOD GPs were asked to screen patient lists generated from computerized record searches for trial eligibility and to provide narrative reasons for excluding patients. These reasons were coded independently by two researchers, with a third researcher resolving discrepancies. RESULTS Thirty-one percent (4750/15,379) of patients were excluded at the GP screening stage, including 663 on patient lists that remained unscreened. Of the 4087 actively excluded patients, 67% were excluded on account of trial exclusion criteria, 20% for other criteria (half of which were comorbid conditions) and 13% without reason. CONCLUSION Clear, comprehensive criteria, particularly with regards to comorbidities, are required for GPs to confidently screen patients for potential participation in research. Future studies should promote inclusivity and encourage GPs to adopt a liberal approach when screening patient lists. This would enhance the validity and generalizability of primary care research and encourage greater patient autonomy.

WHEN AND HOW OLDER PEOPLE DISCUSS PREFERENCES FOR LONG‐TERM CARE OPTIONS

To the Editor: The appropriateness and utility of living wills and advance care planning have come under increasing scrutiny in recent years, particularly for older people. From a position of almost universal support there has been evolution to a more-nuanced view that advance directives may be unrealistic in many clinical settings. This is not surprising, given that aging is associated with increasing heterogeneity, pathways of care become more complex in later life, and older people may suffer from institutionalized agism and a failure to access health care. Although patients are increasingly expected to take an active role in decision-making and planning for their health care, the barriers to older patients doing so are complex. These difficulties become more apparent with advance care planning. A qualitative study assessing views of advance care planning among housebound older people found ‘‘resistance’’ to planning for chronic serious illness. Preferences for long-term care were investigated in a sample of community-dwelling older people as part of the first longitudinal study on aging in Ireland.

Development and refinement of a complex intervention within cardiac rehabilitation services: experiences from the CADENCE feasibility study

BackgroundPatients who experience a cardiac event are at higher risk of developing depression than the general population. Despite this, cardiac rehabilitation (CR) programmes do not provide a systematic approach to psychological care for depression. The CADENCE study aimed to develop and pilot an enhanced psychological care (EPC) intervention consisting of behavioural activation (BA) and mental health care coordination. Following original research commissioning guidance, the intervention was planned to be embedded in routine care and delivered by CR nurses to patients with depression attending CR. This paper describes how qualitative methods were used to develop, embed and refine the intervention.MethodsThis feasibility study involved three CR teams. Observations were made of CR nurses delivering usual care, of EPC training given to nurses, and of supervision sessions provided to the CR nurses. Four nurses were interviewed shortly after their EPC training, and three were interviewed again 6–7 months later having delivered EPC to patients. All nine patients recruited to receive EPC were interviewed. Analyses of the observation notes and interview transcripts focused on how the intervention could be improved in terms of its acceptability and implementation.ResultsVariations were found between the CR teams regarding patient waiting list times, how CR was delivered, what facilities were available and how many CR sessions were offered to patients. EPC was acceptable to both nurses and patients. However, nurses struggled to provide this additional care within their existing workload and resources, and patients’ disrupted progression through the CR programme affected EPC delivery. Limited time and availability of private space meant nurses also delivered EPC by telephone, which was viewed as a pragmatic solution but less preferable than face-to-face. Nurses indicated that patients struggled with some of the written materials. Findings were used to revise the intervention to become a protocol of care coordination which included guided self-help BA.ConclusionsInsights gained through conducting interviews and observations enabled us to identify barriers to the implementation of EPC, and to modify the intervention to facilitate its delivery within existing services whilst remaining acceptable to both nurses and patients. The multiple method, iterative approach used was key to the success of this qualitative study.Trial registrationISRCTN34701576 Registered 29/05/2014.