Generating EQ-5D-3L health utility scores from the Edinburgh Postnatal Depression Scale: a perinatal mapping study.

BACKGROUND: Perinatal depression (PND) describes depression experienced by parents during pregnancy or in the first year after a baby is born. The EQ-5D instrument (a generic measure of health status) is not often collected in perinatal research, however disease-specific measures, such as the Edinburgh Postnatal Depression Scale (EPDS) are widely used. Mapping can be used to estimate generic health utility index values from disease-specific measures like the EPDS. OBJECTIVE: To develop a mapping algorithm to estimate EQ-5D utility index values from the EPDS. METHODS: Patient-level data from the BaBY PaNDA study (English observational cohort study) provided 1068 observations with paired EPDS and EQ-5D (3-level version; EQ-5D-3L) responses. We compared the performance of six alternative regression model types, each with four specifications of covariates (EPDS score and age: base, squared, and cubed). Model performance (ability to predict utility values) was assessed by ranking mean error, mean absolute error, and root mean square error. Algorithm performance in 3 external datasets was also evaluated. RESULTS: There was moderate correlation between EPDS score and utility values (coefficient: - 0.42). The best performing model type was a two-part model, followed by ordinary least squared. Inclusion of squared and cubed covariates improved model performance. Based on graphs of observed and predicted utility values, the algorithm performed better when utility was above 0.6. CONCLUSIONS: This direct mapping algorithm allows the estimation of health utility values from EPDS scores. The algorithm has good external validity but is likely to perform better in samples with higher health status.

Objectively assessed physical activity and lower limb function and prospective associations with mortality and newly diagnosed disease in UK older adults: an OPAL four-year follow-up study.

BACKGROUND: Objective measures of physical activity and function with a diverse cohort of UK adults in their 70s and 80s were used to investigate relative risk of all-cause mortality and diagnoses of new diseases over a 4-year period. PARTICIPANTS: Two hundred and forty older adults were randomly recruited from 12 general practices in urban and suburban areas of a city in the United Kingdom. Follow-up included 213 of the baseline sample. METHODS: Socio-demographic variables, height and weight, and self-reported diagnosed diseases were recorded at baseline. Seven-day accelerometry was used to assess total physical activity, moderate-to-vigorous activity and sedentary time. A log recorded trips from home. Lower limb function was assessed using the Short Physical Performance Battery. Medical records were accessed on average 50 months post baseline, when new diseases and deaths were recorded. ANALYSES: ANOVAs were used to assess socio-demographic, physical activity and lower limb function group differences in diseases at baseline and new diseases during follow-up. Regression models were constructed to assess the prospective associations between physical activity and function with mortality and new disease. RESULTS: For every 1,000 steps walked per day, the risk of mortality was 36% lower (hazard ratios 0.64, 95% confidence interval (CI) 0.44-0.91, P=0.013). Low levels of moderate-to-vigorous physical activity (incident rate ratio (IRR) 1.67, 95% CI 1.04-2.68, P=0.030) and low frequency of trips from home (IRR 1.41, 95% CI 0.98-2.05, P=0.045) were associated with diagnoses of more new diseases. CONCLUSION: Physical activity should be supported for adults in their 70s and 80s, as it is associated with reduced risk of mortality and new disease development.

Evaluation of different recruitment and randomisation methods in a trial of general practitioner-led interventions to increase physical activity: a randomised controlled feasibility study with factorial design.

BACKGROUND: Interventions promoting physical activity by General Practitioners (GPs) lack a strong evidence base. Recruiting participants to trials in primary care is challenging. We investigated the feasibility of (i) delivering three interventions to promote physical activity in inactive participants and (ii) different methods of participant recruitment and randomised allocation. METHODS: We recruited general practices from Devon, Bristol and Coventry. We used a 2-by-2 factorial design for participant recruitment and randomisation. Recruitment strategies were either opportunistic (approaching patients attending their GP surgery) or systematic (selecting patients from practice lists and approaching them by letter). Randomisation strategies were either individual or by practice cluster. Feasibility outcomes included time taken to recruit the target number of participants within each practice. Participants were randomly allocated to one of three interventions: (i) written advice (control); (ii) brief GP advice (written advice plus GP advice on physical activity), and (iii) brief GP advice plus a pedometer to self-monitor physical activity during the trial. Participants allocated to written advice or brief advice each received a sealed pedometer to record their physical activity, and were instructed not to unseal the pedometer before the scheduled day of data collection. Participant level outcomes were reported descriptively and included the mean number of pedometer steps over a 7-day period, and European Quality of Life (EuroQoL)-5 dimensions (EQ-5D) scores, recorded at 12 weeks' follow-up. RESULTS: We recruited 24 practices (12 using each recruitment method; 18 randomising by cluster, 6 randomising by individual participant), encompassing 131 participants. Opportunistic recruitment was associated with less time to target recruitment compared with systematic (mean difference (days) -54.9, 95% confidence interval (CI) -103.6; -6.2) but with greater loss to follow up (28.8% versus. 6.9%; mean difference 21.9% (95% CI 9.6%; 34.1%)). There were differences in the socio-demographic characteristics of participants according to recruitment method. There was no clear pattern of change in participant level outcomes from baseline to 12 weeks across the three arms. CONCLUSIONS: Delivering and trialling GP-led interventions to promote physical activity is feasible, but trial design influences time to participant recruitment, participant withdrawal, and possibly, the socio-demographic characteristics of participants. TRIAL REGISTRATION NUMBER: ISRCTN73725618.

Identifying families' reasons for engaging or not engaging with childhood obesity services: A qualitative study.

The rise in childhood obesity in recent years has been accompanied by a number of initiatives to treat the condition. However, such interventions have often been characterised by poor levels of adherence to treatment and corresponding high attrition rates. This article presents data drawn from qualitative interviews to examine families' reasons for engaging or not engaging with child obesity services. Interviews took place with 15 families whose children attended a UK-based childhood obesity service and 17 families whose children withdrew from treatment. Our data suggested that involvement of children in the decision to attend a clinic was important in building engagement. Specialist diet and exercise advice tailored to individual family circumstance encouraged clinic engagement, but failed to engage some families who felt their personal circumstances had not been considered sufficiently. The clinic environment was viewed as not age appropriate for some children and did not match the expectations of some families. Our findings highlight the value of involving children in the decision to attend an obesity service and practitioners should, as much as possible, tailor advice to the circumstances of each family. Providing clinics for particular age groups in terms of environment and timing may enhance engagement with services.

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.

Is healthy eating for obese children necessarily more costly for families?

BACKGROUND: During consultations on weight management in childhood obesity clinics, the additional costs incurred by healthy eating are often cited, as an economic barrier to achieving a better nutritional balance. AIM: To examine whether adopting an improved theoretical, balanced diet compared to current dietary habits in children incurs additional cost. DESIGN AND SETTING: Children aged 5-16 years (body mass index [BMI] ≥98th percentile) recruited to a randomised trial comparing a hospital-based and primary care childhood obesity clinics provided data for this study. METHOD: Three-day dietary diaries collected at baseline were analysed for energy and fat intake and then compared to a theoretical, adjusted healthy-eating diet based on the Food Standards Agency, 'Eatwell plate'. Both were priced contemporaneously using the appropriate portion size, at a neighbourhood, mid-range supermarket, at a budget supermarket, and on the local high street. RESULTS: The existing diet purchased at a budget supermarket was cheapest (£2.48/day). The healthier, alternative menu at the same shop cost an additional 33 pence/day (£2.81). The same exercise in a mid-range supermarket, incurred an additional cost of 4 pence per day (£3.40 versus £3.44). Switching from an unhealthy mid-range supermarket menu to the healthier, budget-outlet alternative saved 59 pence per day. The healthier, alternative menu was cheaper than the existing diet if purchased on the high street (£3.58 versus £3.75), although for both menus this was most expensive. CONCLUSION: For many obese children, eating healthily would not necessarily incur prohibitive, additional financial cost, although a poor diet at a budget supermarket remains the cheapest of all options. Cost is a possible barrier to healthy eating for the most economically disadvantaged.

Evaluating the transferability of a hospital-based childhood obesity clinic to primary care: a randomised controlled trial.

BACKGROUND: The Care Of Childhood Obesity (COCO) clinic at the Bristol Royal Hospital for Children (BRHC) uses a multidisciplinary approach comprising a consultant, dietitian, and exercise specialist. The clinic has demonstrated efficacy in managing children's weight but similar clinics are scarce in the UK. AIM: This pilot randomised controlled trial (RCT) aimed to examine the feasibility of undertaking a fully powered RCT and to gauge whether the COCO model could be effective as a nurse-led clinic in primary care settings. DESIGN AND SETTING: Patients were randomised to a hospital-based childhood obesity clinic or a nurse-led clinic in a primary care setting in south-west England. METHOD: Children aged 5-16 years with a body mass index (BMI) ≥98th centile were referred by GPs to the consultant in charge of the COCO clinic at BRHC. Referred children were clinically screened for suitability and invited into the study. Consenting families were randomised to BRHC or a primary care clinic (PCC) and offered five appointments over 12 months. Clinical effectiveness was measured by change in body mass index standard deviation score (BMI SDS) at 12 months. Other measures included: treatment adherence, quality of life (QOL), and satisfaction. Feasibility was examined by assessing referral, screening, and recruitment data. RESULTS: A total 152 patients were referred by GPs: 31 (20%) were screened out; 45 (30%) declined to participate. Seventy-six (50%) patients were randomised and 68 provided baseline data (PCC = 42; BRHC = 26); 52 provided outcome data (PCC = 29; BRHC = 23). Mean change in BMI SDS was PCC -0.17 (95% confidence interval [CI] = -0.27 to -0.07); BRHC -0.15 (95% CI = -0.26 to -0.05). QOL, adherence, and satisfaction data indicated similar positive patterns in both trial arms. CONCLUSION: Screening and recruitment data indicate that primary care is a clinically appropriate setting and acceptable to families. The primary clinical outcome measure (reduction in BMI SDS), along with secondary outcome measures, indicate that primary care has the potential to be effective in providing weight management for children, using the COCO model.

Attitudes and adjustment to the parental role in mothers following treatment for postnatal depression.

BACKGROUND: Few intervention studies of postnatal depression (PND) have evaluated accompanying changes in parenting, in spite of mounting evidence that exposure to chronic depression is detrimental to infant development. This study examined maternal attitudes and adjustment over the first postnatal year within a treatment trial. The aim was to examine whether maternal adjustment improved with earlier remission, and with combined medical and psychological treatment. METHODS: As part of a multicentre pragmatic randomised controlled trial of treatment for PND, mothers completed a measure of maternal adjustment and attitudes and the Edinburgh Postnatal Depression Scale at an initial home visit (week 0) and three follow-ups (weeks 4, 18 and 44). RESULTS: Maternal attitudes and adjustment improved with PND remission; earlier remission conferred no additional benefit by 44-week follow-up. In line with previous studies, no particular treatment modality (antidepressant or health-visitor delivered non-directive counselling), or combination of treatments, was more effective for improving adjustment to parenthood. However, the earlier start of antidepressant treatment provided a short-term advantage for improving attitudes and reducing perceived stress. LIMITATIONS: As a result of the study's pragmatic trial design, there was high treatment non-compliance and no 'pure' control group. More depressed mothers may have been less likely to complete the maternal adjustment and attitudes measure. CONCLUSIONS: Effective treatment of PND is important not only for the mother's wellbeing but also for healthy adjustment to parenthood. Provision of treatment choice and early antidepressant treatment are suggested for optimising maternal attitudes and adjustment.

The Bristol Online Obesity Screening Tool: experience of using a screening tool for assessing obese children in primary care.

The incidence of childhood obesity is rising in the United Kingdom and this has far-reaching and serious consequences both for the physical and psychological well-being of the child, as well as significant financial implications for the health service. General practitioners (GPs) play a central role in identifying and assessing such children and directing them to the best services. While most cases of obesity are simply due to an imbalance in calorie intake and expenditure, children do need to be formally assessed to ensure that red flags are not missed, which might signify an important underlying aetiology, co-morbidity or complication. To date, there have not been tools available to guide a GP through this assessment. In this paper, we present and explain the thinking behind a tool, which was developed for use by GPs from Bristolas part of a trial to assess the transferability of a childhood obesity clinic into primary care. We look at the evidence base behind the guidelines and then assess the appropriateness and safety of the 152 referrals made using this tool. We believe that this screening tool would enable over 85% of obese children to seek their initial weight management in primary care. Additional evaluation is needed in different regions to ensure effectiveness, sensitivity and specificity of this new tool.

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. TRIAL REGISTRATION: ISRCTN 16900744.

Expectations of patients and parents of children with asthma regarding access to complementary therapy information and services via the NHS: a qualitative study.

OBJECTIVE: To explore the expectations of patients and parents of children with asthma regarding access to complementary therapies via the NHS. METHODS: Fifty semi-structured interviews with adults and parents of children with asthma, from a range of health-care settings, including users and non-users of complementary therapies. Interviews were recorded, transcribed verbatim and the data were analysed thematically. RESULTS: Thirty-one patients were using complementary therapies for asthma, six were using complementary therapies for other health problems and 13 were non-users. Various therapies were used for asthma, most commonly homeopathy and breathing techniques, predominantly outside the NHS. Two broad themes emerging from the data were expectations about access to information and knowledge about complementary therapies via NHS health professionals, and expectations regarding access to complementary therapy services via the NHS. As a minimum, the majority of participants wanted NHS health professionals to be more 'open' towards and know more about complementary therapies than their patients - perceived as not currently usual. Most were positive about greater NHS access to complementary therapy services, for enhancing patient choice, improving equality in access for less affluent patients and facilitating patients' self-help. Participants who were highly sceptical about complementary therapies argued that lack of scientific evidence of effectiveness prohibited the need for greater complementary therapy knowledge or service provision within the NHS. Alongside their expectations, patients and parents expressed realistic views about facilitators and barriers to greater access. CONCLUSIONS: While health service planners and providers often express reservations about the value of complementary therapies, it is important to take patients' preferences into account if policy discourses regarding patient-centred care and choice are to be realized in practice.

Clinical features of prostate cancer before diagnosis: a population-based, case-control study.

BACKGROUND: Even in areas where screening is available, many prostate cancers are diagnosed after the symptoms begin. However, the risk posed by particular symptoms is largely unknown, especially in unselected populations such as primary care. AIM: To identify and quantify the features of prostate cancer before diagnosis, both individually and in combination. DESIGN OF STUDY: Population-based case-control study. SETTING: All 21 general practices in Exeter, Devon, UK. METHODS: We studied all 217 prostate cancer patients diagnosed between 1998 and 2002, and 1080 male controls, matched by age and general practice. The full medical record for 2 years before diagnosis was coded, using the International Classification of Primary Care. We calculated odds ratios for variables independently associated with cancer, using conditional logistic regression, and calculated the positive predictive values for these, both individually and in combination. RESULTS: Eight features were associated with prostate cancer before diagnosis. Their positive predictive values against a background risk of 0.35% were: urinary retention 3.1% (95% confidence interval [CI] = 1.5 to 6.0); impotence 3.0% (95% CI = 1.7 to 4.9); frequency 2.2% (95% CI = 1.3 to 3.5); hesitancy 3.0% (95% CI = 1.5 to 5.5); nocturia 2.2% (95% CI = 1.2 to 3.6); haematuria 1.0% (95% CI = 0.57 to 1.8); weight loss 0.75% (95% CI = 0.38 to 1.4); abnormal rectal examination, deemed benign 2.8% (95% CI = 1.6 to 4.6); abnormal rectal examination, deemed malignant 12% (95% CI = 5.0 to 37): all P <0.001, except for hesitancy P = 0.032, nocturia P = 0.004 and haematuria P = 0.009. Loss of weight, impotence, frequency and abnormal rectal examination remained associated with cancer after excluding the final 180 days from analysis. CONCLUSION: Most men with prostate cancer present with symptoms. The predictive values for these symptoms will help guide GPs and patients about the value of further investigation.

High incidence of mesothelioma in an English city without heavy industrial use of asbestos.

BACKGROUND: Mesothelioma rates are increasing in the industrialized world, related to occupational asbestos exposure. The highest rates have been reported from areas with specific industries such as shipbuilding or mining. Lower rates have been reported from areas without such industries. We studied an area without heavy industry to examine if such a pattern occurred in England. METHODS: We studied the population of Exeter Primary Care Trust, Devon, United Kingdom, with a population of 131,849. Exeter has no mining, shipbuilding or other heavy industry. All lung cancers and mesotheliomas were identified from the local cancer registry, supplemented by searches at all primary care practices. The cancer diagnoses were checked by inspection of histology or primary care records. Occupational data were extracted from the primary care records. RESULTS: The searches revealed 291 lung cancers, 283 of which had either histological proof or strong clinical evidence for the diagnosis. Twenty-two (8 per cent) of these were pleural mesotheliomas, 17 of these occurring in men. The incidence rate of mesothelioma in men over 40 years was 12.1 per 100,000 per year (95 per cent confidence intervals 7.0-19.3), one of the highest reported rates in the world. CONCLUSION: The mesothelioma epidemic will extend to areas without local heavy industrial exposure.

Variables associated with attendance at, and the perceived helpfulness of, meetings for people with multiple sclerosis.

People who have chronic disabling conditions are frequently advised by health or social care practitioners to attend meetings organised specifically for individuals who have the same or similar health problems. The purpose of the analyses described in the present paper was to ascertain the variables independently associated with attendance at meetings for people with multiple sclerosis (MS), and amongst those who did attend, variables related to the level of perceived helpfulness. A postal questionnaire was sent to a random sample of 471 people with MS in eight randomly selected health authorities/boards across England and Scotland with the general aim of eliciting their preferences for and views of health and social care. There were 318 respondents to this questionnaire (68%), 136 (43%) of whom had attended such a meeting. Logistic regression and proportional odds regression models were used to investigate the relationships with the two outcomes of attendance and helpfulness for 23 explanatory variables drawn from the questionnaire. The explanatory variables related to the following six broad areas: socio-demographic, illness-related, support, self-management, psycho-social factors and social function. Just under half of the respondents reported that they had attended a meeting. Half of these individuals found the last meeting that they had attended to be reasonably helpful, and one in five found it of no help. The individuals who were more likely to have attended were aged 45-64 years, had been in contact with a health professional in the past 12 months and felt that they had the ability and means to access MS-related information. The last meeting was considered more helpful by those who reported greater contentment with access to MS-related information and by those with mild depression. These findings should be useful to health professionals who may consider recommending meetings to people with MS, and also to those who are engaged in ensuring that meetings are both attractive and relevant to all potential attendees.

Factors that contribute to quality of life outcomes prioritised by people with multiple sclerosis.

The aim was to investigate factors associated with depression and social function, two outcomes identified as important by people with multiple sclerosis (MS) and to identify underlying dimensions of psycho-social well-being that may be useful as outcome measures. People with MS in eight randomly selected health authorities/boards in England and Scotland completed a postal questionnaire relating to preferences and needs for their health and social care, along with the Beck Depression Inventory and the SF-36. Responses to 10 of the original items were subjected to factor analysis. These and other explanatory variables were entered into multivariable regression models for the two outcomes. The factor analysis resulted in three dimensions representing different aspects of psycho-social well-being; one of these (representing autonomy) was associated with improvements in both outcomes, as was the SF-36 emotional role limitation score. Three other SF-36 dimensions and lack of contact with a health professional in the last year were related just to social function. The regression models emphasise the value of enabling autonomy and self-reliance amongst people with MS, as well as more general measures of emotional health. The present work identifies specific questions that could be used to measure pivotal aspects of an individual's psycho-social well-being. While these findings warrant replication for people with MS, they may have relevance to those with other long-term illnesses.

Impact of the ICD-10 Primary Health Care (PHC) diagnostic and management guidelines for mental disorders on detection and outcome in primary care. Cluster randomised controlled trial.

BACKGROUND: The World Health Organization (WHO) ICD-10 Primary Health Care (PHC) Guidelines for Diagnosis and Management of Mental Disorders (1996) have not been evaluated in a pragmatic randomised controlled trial (RCT). AIMS: To evaluate the effect of local adaptation and dissemination of the guidelines. METHOD: Pragmatic, pair-matched, cluster RCT involving 30 practices. RESULTS: Guideline practices were less sensitive but more specific in identifying morbidity, but these differences were not significant. Guideline patients did not differ from usual-care patients on 12-item General Health Questionnaire scores at 3-month follow-up or in the proportion who were still cases. There were no significant differences in secondary outcomes. CONCLUSIONS: Attempts to influence clinician behaviour through a process of adaptation and extension of guidelines are unlikely to change detection rates or outcomes.

General practice based intervention to prevent repeat episodes of deliberate self harm: cluster randomised controlled trial.

OBJECTIVES: To evaluate the impact of an intervention based in general practice on the incidence of repeat episodes of deliberate self harm. DESIGN: Cluster randomised controlled trial in which 98 general practices were assigned in equal numbers to an intervention or a control group. The intervention comprised a letter from the general practitioner inviting the patient to consult, and guidelines on assessment and management of deliberate self harm for the general practitioner to use in consultations. Control patients received usual general practitioner care. SETTING: General practices within Avon, Wiltshire, and Somerset Health Authorities, whose patients lived within the catchment area of four general hospitals in Bristol and Bath. PARTICIPANTS: 1932 patients registered with the study practices who had attended accident and emergency departments at one of the four hospitals after an episode of deliberate self harm. MAIN OUTCOME MEASURES: Primary outcome was occurrence of a repeat episode of deliberate self harm in the 12 months after the index episode. Secondary outcomes were number of repeat episodes and time to first repeat. RESULTS: The incidence of repeat episodes of deliberate self harm was not significantly different for patients in the intervention group compared with the control group (odds ratio 1.2, 95% confidence interval 0.9 to 1.5). Similar findings were obtained for the number of repeat episodes and time to first repeat. Subgroup analyses indicated that there was no differential effect of the intervention according to patient's sex (P=0.51) or method used to cause deliberate self harm (P=0.64). The treatment seemed to be beneficial for people with a history of deliberate self harm, but it was associated with an adverse effect in people for whom the index episode was their first episode (interaction P=0.017). CONCLUSIONS: An invitation to consult, sent by the general practitioner of patients who have deliberately harmed themselves, and the use of management guidelines during any subsequent consultation did not reduce the incidence of repeat self harm. A subgroup analysis that indicated that patients who had previously harmed themselves benefited from the intervention was inconsistent with previous evidence and should be treated with caution. More research is needed on how to manage patients who deliberately harm themselves, to reduce the incidence of repeat episodes.