Journal articles
Richards SH, Dickens C, Anderson R, Richards DA, Taylor RS, Ukoumunne OC, Turner KM, Gandhi M, Kuyken W, Gibson A, et al (2018). Assessing the effectiveness of Enhanced Psychological Care for patients with depressive symptoms attending cardiac rehabilitation compared with treatment as usual (CADENCE): a pilot cluster randomised controlled trial.
Trials,
19(1).
Abstract:
Assessing the effectiveness of Enhanced Psychological Care for patients with depressive symptoms attending cardiac rehabilitation compared with treatment as usual (CADENCE): a pilot cluster randomised controlled trial.
BACKGROUND: Around 17% of people attending UK cardiac rehabilitation programmes have depression. Optimising psychological wellbeing is a rehabilitation goal, but provision of psychological care is limited. We developed and piloted an Enhanced Psychological Care (EPC) intervention embedded within cardiac rehabilitation, aiming to test key areas of uncertainty to inform the design of a definitive randomised controlled trial (RCT) and economic evaluation. METHODS: an external pilot randomised controlled trial (RCT) randomised eight cardiac rehabilitation teams (clusters) to either usual care of cardiac rehabilitation provision (UC), or EPC in addition to UC. EPC comprised mental health care coordination and patient-led behavioural activation with nurse support. Adults eligible for cardiac rehabilitation following an acute coronary syndrome and identified with new-onset depressive symptoms during an initial nurse assessment were eligible. Measures were performed at baseline and 5- and 8-month follow-ups and compared between EPC and UC. Team and participant recruitment and retention rates, and participant outcomes (clinical events, depression, anxiety, health-related quality of life, patient experiences, and resource use) were assessed. RESULTS: Eight out of twenty teams were recruited and randomised. of 614 patients screened, 55 were eligible and 29 took part (5%, 95% CI 3 to 7% of those screened), with 15 patient participants cluster randomised to EPC and 14 to UC. Nurse records revealed that 8/15 participants received the maximum number of EPC sessions offered; and 4/15 received no sessions. Seven out of fifteen EPC participants were referred to another NHS psychological service compared to none in UC. We followed up 27/29 participants at 5 months and 17/21 at 8 months. The mean difference (EPC minus UC) in depressive symptoms (Beck Depression Inventory) at follow-up (adjusting for baseline score) was 1.7 (95% CI - 3.8 to 7.3; N = 26) at 5 months and 4.4 (95% CI - 1.4 to 10.2; N = 17) at 8 months. DISCUSSION: While valued by patients and nurses, organisational and workload constraints are significant barriers to EPC implementation. There remains a need to develop and test new models of psychological care within cardiac rehabilitation. Our study offers important data to inform the design of future trials of similar interventions. TRIAL REGISTRATION: ISRCTN34701576. Registered on 29 May 2014. Funding details: UK NIHR HTA Programme (project 12/189/09).
Abstract.
Author URL.
Richards SH, Campbell JL, Dickens C, Anderson R, Gandhi M, Gibson A, Kessler D, Knight L, Kuyken W, Richards DA, et al (2018). Enhanced psychological care in cardiac rehabilitation services for patients with new-onset depression: the CADENCE feasibility study and pilot RCT.
Health Technol Assess,
22(30), 1-220.
Abstract:
Enhanced psychological care in cardiac rehabilitation services for patients with new-onset depression: the CADENCE feasibility study and pilot RCT.
BACKGROUND: Around 19% of people screened by UK cardiac rehabilitation programmes report having moderate or severe symptoms of depression. These individuals are at an increased risk of cardiac mortality and morbidity, reduced quality of life and increased use of health resources compared with their non-depressed counterparts. Maximising psychological health is a goal of cardiac rehabilitation, but psychological care is patchy. OBJECTIVE(S): to examine the feasibility and acceptability of embedding enhanced psychological care (EPC) within cardiac rehabilitation, we tested the feasibility of developing/implementing EPC and documented the key uncertainties associated with undertaking a definitive evaluation. DESIGN: a two-stage multimethods study; a feasibility study and a qualitative evaluation, followed by an external pilot cluster randomised controlled trial (RCT) with a nested qualitative study. SETTING: UK comprehensive cardiac rehabilitation teams. PARTICIPANTS: Adults eligible for cardiac rehabilitation following an acute coronary syndrome with new-onset depressive symptoms on initial nurse assessment. Patients who had received treatment for depression in the preceding 6 months were excluded. INTERVENTIONS: the EPC intervention comprised nurse-led mental health-care co-ordination and behavioural activation within cardiac rehabilitation. The comparator was usual cardiac rehabilitation care. MAIN OUTCOME MEASURES: Measures at baseline, and at the 5- (feasibility and pilot) and 8-month follow-ups (pilot only). Process measures related to cardiac team and patient recruitment, and participant retention. Outcomes included depressive symptoms, cardiac mortality and morbidity, anxiety, health-related quality of life and service resource use. Interviews explored participant and nurses' views and experiences. RESULTS: Between September 2014 and May 2015, five nurses from four teams recruited participants into the feasibility study. of the 203 patients screened, 30 were eligible and nine took part (the target was 20 participants). At interview, participants and nurses gave valuable insights into the EPC intervention design and delivery. Although acceptable, the EPC delivery was challenging for nurses (e.g. the ability to allocate sufficient time within existing workloads) and the intervention was modified accordingly. Between December 2014 and February 2015, 8 out of 20 teams approached agreed to participate in the pilot RCT [five were randomised to the EPC arm and three were randomised to the usual-care (UC) arm]. of the 614 patients screened, 55 were eligible and 29 took part (the target was 43 participants). At baseline, the trial arms were well matched for sex and ethnicity, although the EPC arm participants were younger, from more deprived areas and had higher depression scores than the UC participants. A total of 27 out of 29 participants were followed up at 5 months. Interviews with 18 participants (12 in the EPC arm and six in the UC arm) and seven nurses who delivered EPC identified that both groups acknowledged the importance of receiving psychological support embedded within routine cardiac rehabilitation. For those experiencing/delivering EPC, the intervention was broadly acceptable, albeit challenging to deliver within existing care. LIMITATIONS: Both the feasibility and the pilot studies encountered significant challenges in recruiting patients, which limited the power of the pilot study analyses. CONCLUSIONS: Cardiac rehabilitation nurses can be trained to deliver EPC. Although valued by both patients and nurses, organisational and workload constraints were significant barriers to implementation in participating teams, suggesting that future research may require a modified approach to intervention delivery within current service arrangements. We obtained important data informing definitive research regarding participant recruitment and retention, and optimal methods of data collection. FUTURE RESEARCH: Consideration should be given to the delivery of EPC by dedicated mental health practitioners, working closely with cardiac rehabilitation services. TRIAL REGISTRATION: Current Controlled Trials ISRCTN34701576. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 30. See the NIHR Journals Library website for further project information.
Abstract.
Author URL.
Winder R, Richards SH, Campbell JL, Richards DA, Dickens C, Gandhi M, Wright C, Turner K (2017). Development and refinement of a complex intervention within cardiac rehabilitation services: experiences from the CADENCE feasibility study. Pilot and Feasibility Studies, 3(1).
Turner KM, Winder R, Campbell JL, Richards DA, Gandhi M, Dickens CM, Richards S (2017). Patients' and nurses' views on providing psychological support within cardiac rehabilitation programmes: a qualitative study.
BMJ Open,
7(9).
Abstract:
Patients' and nurses' views on providing psychological support within cardiac rehabilitation programmes: a qualitative study.
OBJECTIVE: to explore patients' and nurses' views on the feasibility and acceptability of providing psychological care within cardiac rehabilitation services. DESIGN: In-depth interviews analysed thematically. PARTICIPANTS: 18 patients and 7 cardiac nurses taking part in a pilot trial (CADENCE) of an enhanced psychological care intervention delivered within cardiac rehabilitation programmes by nurses to patients with symptoms of depression. SETTING: Cardiac services based in the South West of England and the East Midlands, UK. RESULTS: Patients and nurses viewed psychological support as central to good cardiac rehabilitation. Patients' accounts highlighted the significant and immediate adverse effect a cardiac event can have on an individual's mental well-being. They also showed that patients valued nurses attending to both their mental and physical health, and felt this was essential to their overall recovery. Nurses were committed to providing psychological support, believed it benefited patients, and advocated for this support to be delivered within cardiac rehabilitation programmes rather than within a parallel healthcare service. However, nurses were time-constrained and found it challenging to provide psychological care within their existing workloads. CONCLUSIONS: Both patients and nurses highly value psychological support being delivered within cardiac rehabilitation programmes but resource constraints raise barriers to implementation. Consideration, therefore, should be given to alternative forms of delivery which do not rely solely on nurses to enable patients to receive psychological support during cardiac rehabilitation. TRIAL REGISTRATION NUMBER: ISCTRN34701576.
Abstract.
Author URL.
Richards SH, Dickens C, Anderson R, Richards DA, Taylor RS, Ukoumunne OC, Kessler D, Turner K, Kuyken W, Gandhi M, et al (2016). Assessing the effectiveness of enhanced psychological care for patients with depressive symptoms attending cardiac rehabilitation compared with treatment as usual (CADENCE): study protocol for a pilot cluster randomised controlled trial.
Trials,
17Abstract:
Assessing the effectiveness of enhanced psychological care for patients with depressive symptoms attending cardiac rehabilitation compared with treatment as usual (CADENCE): study protocol for a pilot cluster randomised controlled trial.
BACKGROUND: Around 17% of people eligible for UK cardiac rehabilitation programmes following an acute coronary syndrome report moderate or severe depressive symptoms. While maximising psychological health is a core goal of cardiac rehabilitation, psychological care can be fragmented and patchy. This study tests the feasibility and acceptability of embedding enhanced psychological care, composed of two management strategies of proven effectiveness in other settings (nurse-led mental health care coordination and behavioural activation), within the cardiac rehabilitation care pathway. METHODS/DESIGN: This study tests the uncertainties associated with a large-scale evaluation by conducting an external pilot trial with a nested qualitative study. We aim to recruit and randomise eight comprehensive cardiac rehabilitation teams (clusters) to intervention (embedding enhanced psychological care into routine cardiac rehabilitation programmes) or control (routine cardiac rehabilitation programmes alone) arms. Up to 64 patients (eight per team) identified with depressive symptoms upon initial assessment by the cardiac rehabilitation team will be recruited, and study measures will be administered at baseline (before starting rehabilitation) and at 5 months and 8 months post baseline. Outcomes include depressive symptoms, cardiac mortality and morbidity, anxiety, health-related quality of life and service resource use. Trial data on cardiac team and patient recruitment, and the retention and flow of patients through treatment will be used to assess intervention feasibility and acceptability. Qualitative interviews will be undertaken to explore trial participants' and cardiac rehabilitation nurses' views and experiences of the trial methods and intervention, and to identify reasons why patients declined to take part in the trial. Outcome data will inform a sample size calculation for a definitive trial. DISCUSSION: the pilot trial and qualitative study will inform the design of a fully powered cluster randomised controlled trial to evaluate the effectiveness and cost-effectiveness of the provision of enhanced psychological care within cardiac rehabilitation programmes. TRIAL REGISTRATION: ISRCTN34701576 (Registered 29 May 2014).
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Ble A, Masoli JAH, Barry HE, Winder RE, Tavakoly B, Henley WE, Kuchel GA, Valderas JM, Melzer D, Richards SH, et al (2015). Any versus long-term prescribing of high risk medications in older people using 2012 Beers Criteria: results from three cross-sectional samples of primary care records for 2003/4, 2007/8 and 2011/12.
BMC Geriatr,
15Abstract:
Any versus long-term prescribing of high risk medications in older people using 2012 Beers Criteria: results from three cross-sectional samples of primary care records for 2003/4, 2007/8 and 2011/12.
BACKGROUND: High risk medications are commonly prescribed to older US patients. Currently, less is known about high risk medication prescribing in other Western Countries, including the UK. We measured trends and correlates of high risk medication prescribing in a subset of the older UK population (community/institutionalized) to inform harm minimization efforts. METHODS: Three cross-sectional samples from primary care electronic clinical records (UK Clinical Practice Research Datalink, CPRD) in fiscal years 2003/04, 2007/08 and 2011/12 were taken. This yielded a sample of 13,900 people aged 65 years or over from 504 UK general practices. High risk medications were defined by 2012 Beers Criteria adapted for the UK. Using descriptive statistical methods and regression modelling, prevalence of 'any' (drugs prescribed at least once per year) and 'long-term' (drugs prescribed all quarters of year) high risk medication prescribing and correlates were determined. RESULTS: While polypharmacy rates have risen sharply, high risk medication prevalence has remained stable across a decade. A third of older (65+) people are exposed to high risk medications, but only half of the total prevalence was long-term (any = 38.4 % [95 % CI: 36.3, 40.5]; long-term = 17.4 % [15.9, 19.9] in 2011/12). Long-term but not any high risk medication exposure was associated with older ages (85 years or over). Women and people with higher polypharmacy burden were at greater risk of exposure; lower socio-economic status was not associated. Ten drugs/drug classes accounted for most of high risk medication prescribing in 2011/12. CONCLUSIONS: High risk medication prescribing has not increased over time against a background of increasing polypharmacy in the UK. Half of patients receiving high risk medications do so for less than a year. Reducing or optimising the use of a limited number of drugs could dramatically reduce high risk medications in older people. Further research is needed to investigate why the oldest old and women are at greater risk. Interventions to reduce high risk medications may need to target shorter and long-term use separately.
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Author URL.
Melzer D, Tavakoly B, Winder RE, Masoli JAH, Henley WE, Ble A, Richards SH (2015). Much more medicine for the oldest old: trends in UK electronic clinical records.
Age Ageing,
44(1), 46-53.
Abstract:
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
Abstract.
Author URL.
Masoli J, Winder R, Tavakoly B, Henley W, Ble A, Richards S, Melzer D (2014). 63. OVERDIAGNOSING AND MISSING THE POINT?. Age and Ageing, 43(suppl 2), ii19-ii19.
Jenkinson CE, Winder RE, Sugg HVR, Roberts MJ, Ridgway N, Kuyken W, Wiles N, Kessler D, Campbell J (2014). Why do GPs exclude patients from participating in research? an exploration of adherence to and divergence from trial criteria.
Fam Pract,
31(3), 364-370.
Abstract:
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.
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Chalder M, Wiles NJ, Campbell J, Hollinghurst SP, Haase AM, Taylor AH, Fox KR, Costelloe C, Searle A, Baxter H, et al (2013). Facilitated physical activity as a treatment for depressed adults: randomised controlled trial (Reprint from BMJ, vol 344, pg e2758, 2012).
BRITISH JOURNAL OF SPORTS MEDICINE,
47(10), 629-629.
Author URL.
Chalder M, Wiles NJ, Campbell J, Hollinghurst SP, Haase AM, Taylor AH, Fox KR, Costelloe C, Searle A, Baxter H, et al (2013). Republished research: Facilitated physical activity as a treatment for depressed adults: Randomised controlled trial.
British Journal of Sports Medicine,
47(10).
Abstract:
Republished research: Facilitated physical activity as a treatment for depressed adults: Randomised controlled trial
Study question: Does facilitated physical activity provide an effective treatment for adults with depression presenting in primary care? Summary answer: Although trial participants receiving the physical activity intervention in addition to usual care reported increased physical activity compared with those receiving usual care alone, there was no evidence to suggest that the intervention brought about any improvement in depressive symptoms or reduction in antidepressant use. What is known and what this paper adds: Numerous studies have reported the positive effects of physical activity, but most of the current evidence originates from small non-clinical samples using interventions that are not practicable in a healthcare setting. Our results indicate that offering patients a facilitated physical activity intervention is not an effective strategy for reducing symptoms of depression, although it increased self reported physical activity and sustained this effect over 12 months.
Abstract.
Chalder M, Wiles NJ, Campbell J, Hollinghurst SP, Searle A, Haase AM, Taylor AH, Fox KR, Baxter H, Davis M, et al (2012). 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.
Health Technology Assessment,
16(10).
Abstract:
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 selfadministered 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. © Queen's Printer and Controller of HMSO 2012.
Abstract.
Chalder M, Wiles NJ, Campbell J, Hollinghurst SP, Searle A, Haase AM, Taylor AH, Fox KR, Baxter H, Davis M, et al (2012). 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.
Health Technol Assess,
16(10), 1-iv.
Abstract:
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.
Abstract.
Author URL.
Chalder M, Wiles NJ, Campbell J, Hollinghurst SP, Haase AM, Taylor AH, Fox KR, Costelloe C, Searle A, Baxter H, et al (2012). Facilitated physical activity as a treatment for depressed adults: Randomised controlled trial.
BMJ (Online),
344(7860).
Abstract:
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.
Abstract.
Richards SH, Winder R, Seamark C, Seamark D, Avery S, Gilbert J, Barwick A, Campbell JL (2011). The experiences and needs of people seeking palliative health care out-of-hours: a qualitative study.
Prim Health Care Res Dev,
12(2), 165-178.
Abstract:
The experiences and needs of people seeking palliative health care out-of-hours: a qualitative study.
AIM: to explore the experiences of people with advanced cancer and/or their caregivers accessing out-of-hours care. BACKGROUND: the organisation and delivery of out-of-hours in the United Kingdom has undergone major reforms over the past three decades culminating in the new General Medical Service contract in 2004. There are concerns around continuity of care for patients with complex needs under the new arrangements. DESIGN: a qualitative interview study was undertaken recruiting patients from two primary care trusts in Southwest England. Semi-structured interviews were conducted with 28 people with advanced cancer and/or their caregivers who had recently requested out-of-hours care. Interviews were recorded, transcribed and analysed thematically. FINDINGS: Two main themes were identified including the legitimacy of seeking help and continuities of care. Most participants were reluctant to seek help, finding it difficult to decide whether their needs were sufficient to contact services. The degree to which services legitimised participants' requests mediated their experiences. Distress arose when services were dismissive of their needs, whereas respondents were appreciative of clinicians who provided them with reassurance. Participants reported a lack of relational and informational continuity of care. Consulting with an unfamiliar clinician out-of-hours raised doubts in some participants' minds about the quality of care. Some participants recounted episodes in which there were problems with pain management. While the themes suggest that the delivery of out-of-hours care as a whole was not always perfect, around-the-clock access to professional sources of support and reassurance was highly valued. However, the transfer of information to out-of-hours providers remains a key challenge; participants did not understand why out-of-hours providers could not access more information on their medical histories given the level of computerisation within the National Health Service. The findings highlight the need to improve continuity between in-hours and out-of-hours services for patients with complex needs.
Abstract.
Author URL.
Baxter H, Winder R, Chalder M, Wright C, Sherlock S, Haase A, Wiles N, Montgomery AA, Taylor AH, Fox KR, et al (2010). Physical activity as a treatment for depression:
the TREAD randomised trial protocol.
TrialsAbstract:
Physical activity as a treatment for depression:
the TREAD randomised trial protocol
Background: Depression 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/design: the 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.
Discussion: the 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.
Abstract.
Garavan R, McGee HM, Winder R, O'Neill D (2009). When and how older people discuss preferences for long-term care options.
J Am Geriatr Soc,
57(4), 750-751.
Author URL.
Richards SH, Winder R, Seamark D, Seamark C, Ewings P, Barwick A, Gilbert J, Avery S, Human S, Campbell JL, et al (2008). Accessing out-of-hours care following implementation of the GMS contract: an observational study.
Br J Gen Pract,
58(550), 331-338.
Abstract:
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
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Vind AB, Andersen HE, Schwarz P, Skalska A, Salakowski A, Dubiel M, Fedak D, Grodzicki T, Annweiler C, Schott A-M, et al (2008). Oral and Poster Papers Submitted for Presentation at the 5th Congress of the EUGMS “Geriatric Medicine in a Time of Generational Shift September 3–6, 2008 Copenhagen, Denmark. The journal of nutrition, health & aging, 12(8), 545-593.
Winder R, Richards S, Wyatt K, Campbell J (2008). Receiving specialist welfare benefit within Social Services: a qualitative interview study of older people and their carers. Research Policy and Planning, 26(1), 33-43.
Evans PH, Greaves C, Winder R, Fearn-Smith J, Campbell JL (2007). 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).
Diabet Med,
24(7), 770-777.
Abstract:
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. METHODS: Mixed qualitative methodology within an action research framework. Focus group interviews with patients and health professionals and discussion with an expert reference group aimed to identify the important messages and produce a draft toolkit. Two action research cycles were then conducted in two general practices, during which the draft toolkit was used and video-taped consultations and follow-up patient interviews provided further data. Framework analysis techniques were used to examine the data and to elicit action points for improving the toolkit. RESULTS: the key messages about pre-diabetes concerned the seriousness of the condition, the preventability of progression to diabetes, and the need for lifestyle change. As well as feedback on the acceptability and use of the toolkit, four main themes were identified in the data: knowledge and education needs (of both patients and health professionals); communicating knowledge and motivating change; redesign of practice systems to support pre-diabetes management and the role of the health professional. The toolkit we developed was found to be an acceptable and useful resource for both patients and health practitioners. CONCLUSIONS: Three key messages about pre-diabetes were identified. A toolkit of information materials for patients with pre-diabetes and the health professionals and ideas for improving practice systems for managing pre-diabetes were developed and successfully piloted. Further work is needed to establish the best mode of delivery of the WAKEUP toolkit.
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Campbell J, Winder R, Richards SH, Hobart J (2007). Exploring the relationships between provision of welfare benefits advice and the health of elderly people: a longitudinal observational study and discussion of methodological issues.
Health Soc Care Community,
15(5), 454-463.
Abstract:
Exploring the relationships between provision of welfare benefits advice and the health of elderly people: a longitudinal observational study and discussion of methodological issues.
Provision of welfare benefits advice to maximise financial benefit uptake is a shared goal for social and health policy in the UK. The study was designed to explore the wider impact on elderly people provided with specialist welfare benefits advice, in terms of their health and quality of life. This paper reports on a longitudinal postal survey of community dwellers aged 60 and over referred for specialist welfare benefits advice within social services and who were followed up at 5 months (over 2003-2004). Outcome measures included the Short Form-36 (SF-36), the General Health Questionnaire-12 (GHQ-12) and the Barthel Index (postal version), along with questions relating to chronic illness. We also report on the methodological issues that arise from conducting research of this nature. Out of 233 elderly people sent questionnaires, 77 (33%) returned a completed baseline questionnaire. of the 156 who did not return questionnaires, 35 (22%) gave reasons of being 'too unwell' to participate. Between baseline and follow-up, 8 (10%) of the 77 respondents died; 52 of the 69 (75%) remaining participants completed follow-up questionnaires. Although low, these response rates are comparable with other similar questionnaire surveys examining the outcome of providing benefits advice to individuals. Elderly people (mean age = 80.3, SD = 8.6 years) receiving welfare benefits advice usually reported the presence of a longstanding illness or disability, and the use of healthcare services. Baseline SF-36 scores were extremely low and remained largely unchanged at follow-up; however, there were significant improvements in GHQ-12 scores (mean difference = -1.45, 95% CI = -2.63 to -0.27, P = 0.017). Significant increases in benefit income were identified in 65% of respondents with complete financial data sets (mean increase = pound14.73 per week; 95% CI = 5.27-24.18, d.f. = 39, P = 0.003). Participants were very vulnerable in their health status (compared with normative data for elderly people), and this may have contributed to the difficulty in engaging them in the research. There are methodological issues around establishing cause and effect in this type of study, which cannot be readily designed out on account of ethical issues. Extraction and analysis of financial status and benefit eligibility with a view to determining absolute changes in the material well-being of vulnerable individuals over time is a complex and challenging task. Use of suitable measures is essential. Innovative strategies are necessary to maximise survey response rates amongst the vulnerable elderly population.
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Armstrong D, Winder R, Wallis R (2006). Impediments to policy implementation: the offer of free installation of central heating to an elderly community has limited uptake.
Public Health,
120(2), 161-166.
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Impediments to policy implementation: the offer of free installation of central heating to an elderly community has limited uptake.
OBJECTIVES: Increasing the warmth of homes in the UK to combat excess winter mortality has become an important part of public policy. This study examined the success of a local initiative to provide free installation of central heating for a group of elderly people. STUDY DESIGN: Cohort study. METHODS: the uptake of the offer of central heating was monitored through its different stages. Where possible, comments were invited from the elderly tenants to whom the offer was made; a sub-sample was interviewed about their views. RESULTS: of 1181 tenants approached, only around one-quarter finally received central heating within the year. Reasons for the low uptake included inaccuracies in estimating those eligible as well as tenants' worries over upheaval and mess, health concerns and fear of increased heating costs. CONCLUSION: Successful policy implementation requires not only command of appropriate financial resources and the backing of local 'implementers', but also the local resources with which the policy will engage, especially local knowledge, and the 'targets' of the policy initiative, in this case the elderly tenants.
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Winder R, Borrill J (1998). Fuels for memory: the role of oxygen and glucose in memory enhancement.
Psychopharmacology (Berl),
136(4), 349-356.
Abstract:
Fuels for memory: the role of oxygen and glucose in memory enhancement.
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.
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