Mark Gabbay

Randomised controlled trial of non-directive counselling, cognitive-behaviour therapy, and usual general practitioner care for patients with depression. II Cost-effectiveness

Abstract Objective: To compare the clinical effectiveness of general practitioner care and two general practice based psychological therapies for depressed patients. Design: Prospective, controlled trial with randomised and patient preference allocation arms. Setting: General practices in London and greater Manchester. Participants: 464 of 627 patients presenting with depression or mixed anxiety and depression were suitable for inclusion. Interventions: Usual general practitioner care or up to 12 sessions of non-directive counselling or cognitive-behaviour therapy provided by therapists. Main outcome measures: Beck depression inventory scores, other psychiatric symptoms, social functioning, and satisfaction with treatment measured at baseline and at 4 and 12 months. Results: 197 patients were randomly assigned to treatment, 137 chose their treatment, and 130 were randomised only between the two psychological therapies. All groups improved significantly over time. At four months, patients randomised to non-directive counselling or cognitive-behaviour therapy improved more in terms of the Beck depression inventory (mean (SD) scores 12.9 (9.3) and 14.3 (10.8) respectively) than those randomised to usual general practitioner care (18.3 (12.4)). However, there was no significant difference between the two therapies. There were no significant differences between the three treatment groups at 12 months (Beck depression scores 11.8 (9.6), 11.4 (10.8), and 12.1 (10.3) for non-directive counselling, cognitive-behaviour therapy, and general practitioner care). Conclusions: Psychological therapy was a more effective treatment for depression than usual general practitioner care in the short term, but after one year there was no difference in outcome.

Choice and birth method : mixed-method study of caesarean delivery for maternal request

Objective  To explore whether women view decision‐making surrounding vaginal or caesarean birth as their choice.

Randomised controlled trial to determine the clinical effectiveness and cost-effectiveness of selective serotonin reuptake inhibitors plus supportive care, versus supportive care alone, for mild to moderate depression with somatic symptoms in primary care: the THREAD (THREshold for AntiDepressant response) study

OBJECTIVES To determine (1) the effectiveness and cost-effectiveness of selective serotonin reuptake inhibitor (SSRI) treatment plus supportive care, versus supportive care alone, for mild to moderate depression in patients with somatic symptoms in primary care; and (2) the impact of the initial severity of depression on effectiveness and relative costs. To investigate the impact of demographic and social variables. DESIGN The study was a parallel group, open-label, pragmatic randomised controlled trial. SETTING The study took place in a UK primary care setting. Patients were referred by 177 GPs from 115 practices around three academic centres. PARTICIPANTS Patients diagnosed with new episodes of depression and potentially in need of treatment. In total, 602 patients were referred to the study team, of whom 220 were randomised. INTERVENTIONS GPs were asked to provide supportive care to all participants in follow-up consultations 2, 4, 8 and 12 weeks after the baseline assessment, to prescribe an SSRI of their choice to patients in the SSRI plus supportive care arm and to continue treatment for at least 4 months after recovery. They could switch antidepressants during treatment if necessary. They were asked to refrain from prescribing an antidepressant to those in the supportive care alone arm during the first 12 weeks but could prescribe to these patients if treatment became necessary. MAIN OUTCOME MEASURES The primary outcome measure was Hamilton Depression Rating Scale (HDRS) score at 12-week follow-up. Secondary outcome measures were scores on HDRS at 26-week follow-up, Beck Depression Inventory, Medical Outcomes Study Short Form-36 (SF-36), Medical Interview Satisfaction Scale (MISS), modified Client Service Receipt Inventory and medical record data. RESULTS SSRIs were received by 87% of patients in the SSRI plus supportive care arm and 20% in the supportive care alone arm. Longitudinal analyses demonstrated statistically significant differences in favour of the SSRI plus supportive care arm in terms of lower HDRS scores and higher scores on the SF-36 and MISS. Significant mean differences in HDRS score adjusted for baseline were found at both follow-up points when analysed separately but were relatively small. The numbers needed to treat for remission (to HDRS > 8) were 6 [95% confidence interval (CI) 4 to 26)] at 12 weeks and 6 (95% CI 3 to 31) at 26 weeks, and for significant improvement (HDRS reduction > or = 50%) were 7 (95% CI 4 to 83) and 5 (95% CI 3 to 13) respectively. Incremental cost-effectiveness ratios and cost-effectiveness planes suggested that adding an SSRI to supportive care was probably cost-effective. The cost-effectiveness acceptability curve for utility suggested that adding an SSRI to supportive care was cost-effective at the values of 20,000 pounds-30,000 pounds per quality-adjusted life-year. A poorer outcome on the HDRS was significantly related to greater severity at baseline, a higher physical symptom score and being unemployed. CONCLUSIONS Treatment with an SSRI plus supportive care is more effective than supportive care alone for patients with mild to moderate depression, at least for those with symptoms persisting for 8 weeks and an HRDS score of > or = 12. The additional benefit is relatively small, and may be at least in part a placebo effect, but is probably cost-effective at the level used by the National Institute for Health and Clinical Excellence to make judgements about recommending treatments within the National Health Service. However, further research is required.

Expectations and experiences of eHealth in primary care: A qualitative practice-based investigation

OBJECTIVES (1) To assess expectations and experiences of a new eHealth service by patients and staff in three primary care settings; (2) to ascertain attitudes to a range of future, primary care-oriented eHealth services. DESIGN Qualitative case study. SETTING Three UK general practices introducing an eHealth service for booking patient appointments. PARTICIPANTS Ninety patients purposively selected from users and non-users of the new service and 28 staff (clinicians, management and administrative staff). RESULTS Actual patient use of the service was lower than stated intention. Patients and staff felt that more active promotion of the service would have resulted in more use. Low usage did not result in a negative assessment of the service by most staff. Different patient groupings were identified with characteristics that may be used as predictors of eHealth service use and indicators of training needs. GPs and patients expressed opposing viewpoints on a range of future eHealth services. CONCLUSIONS Take-up of eHealth services may be lower than expected. To overcome patient barriers, factors that may narrow the intention-behaviour gap such as level of service promotion, GP endorsement, and usage by different patient groups, should be investigated. For clinician barriers, the eHealth evidence base needs strengthening, while for primary care practices, a learning process including staff training needs to be instituted. The differing views of patients and GPs about components of eHealth means that policymakers need to plan for a lengthy political process to obtain agreement on contentious issues if they are to achieve successful eHealth services.

Accident or suicide? Predictors of Coroners' decisions in suicide and accident verdicts

Objective To examine the factors used by Coroners to distinguish between suicide and accidental death among young men in Merseyside and Cheshire. Design Retrospective epidemiological survey of deaths due to external causes. Data sources included Coroners Inquest, GP and hospital data. Logistic regression was carried out to determine the multiple effect of individual factors on defining Coroners verdict. Setting Merseyside and Cheshire, United Kingdom. Subjects Males aged 15–39 years who died from unnatural causes during 1995 in Merseyside and Cheshire. Main outcome measure Coroners verdict. Results An active mode of death was by far the strongest predictor of a suicide as opposed to an accident verdict. Other significant differentiating factors included expressed intent, behavioural change, deliberate self-harm and psychiatric contact. Conclusion The validity of using method of death as a predictor of intent is questionable. Evidence left by drug users who kill themselves may differ from that left by non-drug users and may need to be sought in less conventional ways. There may be a discrepancy between those factors deemed important by health professionals as indicators of suicide, such as deliberate self-harm, and those given most weight by the Coroner. It may be more pragmatic, in terms of public health policy development, to challenge the concept that self-destructive behaviour can be categorized as being either intentional or unintentional. There is some evidence suggesting that deaths due to suicide and accidents both result from elements of self-destructive behaviour and therefore, the practice of categorizing deaths as either suicides or accidents could be misleading.

NICE guidance on long-term sickness and incapacity

Long-term sickness absence and incapacity benefits (disability pension) rates have increased across industrialised countries. Effective measures are needed to support return to work. The recommendations of this guidance were informed by the most appropriate available evidence of effectiveness and cost-effectiveness. Public health evidence was provided by research using a variety of study designs that attempted to determine the outcome of a particular intervention by evaluating status before and after the intervention had been effected, and was not limited to randomised control trials. Where the evidence base was depleted or underdeveloped, expert witnesses were called to give their opinion on the best available evidence and emerging interventions. The process enabled challenge and contestability from stakeholder groups at different points as the guidance was developed. Forty-five heterogeneous studies were included in the review of interventions to reduce long-term sickness absence and transitions from short-term to long-term absence (mainly covering the former and also mainly examining musculoskeletal conditions). The analysis of evidence was restricted to descriptive synthesis. Three general themes emerged from an analysis of the studies that were more likely to report positive results: early interventions; multidisciplinary approaches; and interventions with a workplace component. Two further reviews were undertaken, one on interventions to reduce the re-occurrence of sickness absence, which identified seven studies on lower back pain, and concluded that early intervention and direct workplace input are important factors. The final evidence review focused on six studies of interventions for those in receipt of incapacity benefit. The evidence was that work-focused interviews coupled with access to tailored support are effective and cost-effective interventions. Practitioners should consider the impact of interventions and management options on work ability for patients of working age. Work ability should be considered a key outcome for future intervention studies.

Researching the mental health needs of hard-to-reach groups: managing multiple sources of evidence.

BackgroundCommon mental health problems impose substantial challenges to patients, carers, and health care systems. A range of interventions have demonstrable efficacy in improving the lives of people experiencing such problems. However many people are disadvantaged, either because they are unable to access primary care, or because access does not lead to adequate help. New methods are needed to understand the problems of access and generate solutions. In this paper we describe our methodological approach to managing multiple and diverse sources of evidence, within a research programme to increase equity of access to high quality mental health services in primary care.MethodsWe began with a scoping review to identify the range and extent of relevant published material, and establish key concepts related to access. We then devised a strategy to collect - in parallel - evidence from six separate sources: a systematic review of published quantitative data on access-related studies; a meta-synthesis of published qualitative data on patient perspectives; dialogues with local stakeholders; a review of grey literature from statutory and voluntary service providers; secondary analysis of patient transcripts from previous qualitative studies; and primary data from interviews with service users and carers.We synthesised the findings from these diverse sources, made judgements on key emerging issues in relation to needs and services, and proposed a range of potential interventions. These proposals were debated and refined using iterative electronic and focus group consultation procedures involving international experts, local stakeholders and service users.ConclusionsOur methods break new ground by generating and synthesising multiple sources of evidence, connecting scientific understanding with the perspectives of users, in order to develop innovative ways to meet the mental health needs of under-served groups.

Lay perceptions of the desired role and type of user involvement in clinical governance.

Objective  The aim of this paper is to explore variations in lay perceptions of user involvement in clinical governance.

Motivating patients with shoulder and back pain to self-care: can a videotape of exercise support physiotherapy?

OBJECTIVES The National Health Service is developing an ethos of self-care. Patients are being encouraged to become proficient in helping themselves. This has long been a philosophy of the physiotherapy profession, where self-care between consultations has been an integral part of the treatment process through encouraging the uptake of self-care skills training. This study explored how patients with shoulder and back pain perceived videotaped exercises and instructions to support their routine physiotherapy, and how the videotape was used. DESIGN A videotape, developed by physiotherapists for patients with musculoskeletal problems, of exercises to view at home was given to patients by their physiotherapists to support their routine physiotherapy consultations. A qualitative methodology was used to examine how patients responded to being given a videotape of exercises and instructions between consultations. Data were collected through semi-structured interviews. SETTING The study was based in 26 general practices that had access to practice-based physiotherapists in two primary care trusts in the north-west of England. PARTICIPANTS Thirty-three patients with shoulder and back pain who received a videotape of exercises and advice were interviewed. RESULTS Three themes emerged from the data: finding space for exercise; remembering and doing exercises; and supporting the physiotherapy-patient relationship. Patients discussed aspects of motivation, and described how a videotape of exercises might support or inhibit the performance of exercises prescribed by physiotherapists. Patients identified a range of different ways in which they derived support from the videotape. CONCLUSIONS The videotape supported patients with a variety of different needs as it enhanced their ability to complete exercises correctly. Videotapes (or DVDs) are useful for patients and could be adopted as a tool to support treatment.

Factors associated with the length of fit note-certified sickness episodes in the UK

Objectives To identify diagnostic, patient/employee, general practitioner (GP) and practice factors associated with length of certified sickness episodes. Methods Twelve-month collection of fit note data at 68 general practices in eight regions of England, Wales and Scotland between 2011 and 2013. Secondary analysis of sick note data collected at seven general practices in 2001/2002. All employed patients receiving at least one fit note at practices within the collection period were included in the study. Main study outcomes were certified sickness episodes lasting longer than 3, 6 and 12 weeks. Results The data from seven practices contributing in 2013, and a decade previously, suggest that periods of long-term sickness absence may be falling overall (risk >12 weeks absence, OR=0.65) but the proportion of mild–moderate mental disorder-related (M-MMD) episodes is rising (26% to 38%). Over 32% (8064/25 078) of fit notes issued to working patients in the 68 practices were for a M-MMD. A total of 13 994 patient sickness ‘episodes’ were identified. Diagnostic category of episode, male patients, older patient age and higher social deprivation were significantly associated with the >3 week, >6 week and long-term (>12 week) outcomes, and GP partner status with the long-term outcome only. Conclusions In the context of a rapidly changing legislative environment, the study used the largest sickness certification database constructed in the UK to enhance the evidence base relating to factors contributing to long-term work incapacity.