Showing papers by "Clare Wilkinson published in 2003"

Estimating psychological treatment effects from a randomised controlled trial with both non-compliance and loss to follow-up

Abstract: Background The Outcomes of Depression International Network (ODIN) trial evaluated the effect of two psychological interventions for the treatment of depression in primary care. Only about half of the patients in the treatment arm complied with the offer of treatment, prompting the question:‘what was the effect of treatment in those patients who actually received it?’ Aims To illustrate the estimation of the effect of receipt of treatment in a randomised controlled trial subject to non-compliance and loss to follow-up. Method We estimated the complier average causal effect (CACE) of treatment. Results In the ODIN trial the effect of receipt of psychological intervention (an average of about 4 points on the Beck Depression Inventory) is about twice that of offering it. Conclusions The statistical analysis of the results of a clinical trial subjectto non-compliance to allocated treatment is now reasonably straightforward through estimation of a CACE and investigators should be encouraged to present the results of analyses of this type as a routine component of a trial report.

Randomized osteopathic manipulation study (ROMANS): pragmatic trial for spinal pain in primary care.

Abstract: Background. Spinal pain is common and frequently disabling. Management guidelines have encouraged referral from primary care for spinal manipulation. However, the evidence base for these recommendations is weak. More pragmatic trials and economic evaluations have been recommended. Objectives. Our aim was to assess the effectiveness and health care costs of a practice-based osteopathy clinic for subacute spinal pain. Methods. A pragmatic randomized controlled trial was carried out in a primary care osteopathy clinic accepting referrals from 14 neighbouring practices in North West Wales. A total of 201 patients with neck or back pain of 2–12 weeks duration were allocated at random between usual GP care and an additional three sessions of osteopathic spinal manipulation. The primary outcome measure was the Extended Aberdeen Spine Pain Scale (EASPS). Secondary measures included SF-12, EuroQol and Short-form McGill Pain Questionnaire. Health care costs were estimated from the records of referring GPs. Results. Outcomes improved more in the osteopathy group than the usual care group. At 2 months, this improvement was significantly greater in EASPS [95% confidence interval (CI) 0.7–9.8] and SF-12 mental score (95% CI 2.7–10.7). At 6 months, this difference was no longer significant for EASPS (95% CI ?1.5 to 10.4), but remained significant for SF-12 mental score (95% CI 1.0–9.9). Mean health care costs attributed to spinal pain were significantly greater by £65 in the osteopathy group (95% CI £32–£155). Though osteopathy also cost £22 more in mean total health care cost, this was not significant (95% CI ?£159 to £142). Conclusion. A primary care osteopathy clinic improved short-term physical and longer term psychological outcomes, at little extra cost. Rigorous multicentre studies are now needed to assess the generalizability of this approach.

Urban-rural differences in the occurrence of female depressive disorder in Europe--evidence from the ODIN study.

Abstract: Background: In an earlier paper of the European multi-centre ODIN study (Ayuso-Mateos et al. 2001) we found remarkable urban preponderance in comparison to the corresponding rural site in the female prevalence of depressive disorder in the UK and Ireland. The aim of this paper is to analyse the possible reasons for this finding. Method: A representative sample of 12,702 people aged between 18 and 64 residing in specified urban and rural areas were screened by the Beck Depression Inventory (BDI) for depressive disorder in four European countries (Finland, Ireland, Norway and the UK). Those over cut-off (BDI score < 12) and a 5 % random sample of those under cut-off underwent diagnostic interview including the SCAN version 2.0, and completed a battery of additional research instruments. Results: The estimated 1-month prevalence of depressive disorder according to ICD-10 was 9 % in the total ODIN sample. A large between-country variation was found in female urban prevalence, with Ireland (Dublin) and the UK (Liverpool) having a remarkably high rate. The women in these same countries showed a significant urban/rural difference, whereas in men and in the total sample this difference was non-significant. Logistic regression analysis including some selected risk factors of depression showed still higher risk of depressive disorder both in Dublin and Liverpool compared with the Finnish urban site (Turku), which had the lowest urban prevalence. In addition, also such factors as lack of confidant and having difficulties in getting practical help from neighbours were important predictors of depressive disorder. Similarly, when analysing the different countries separately, the significance of the urban/rural difference in women remained for Ireland and the UK, indicating that the other risk factors studied could not totally explain the difference. Conclusions: ODIN is the first European study on occurrence of depressive disorder in both urban and rural settings allowing closer analysis of the urban/rural differences. The most striking result was the large urban/rural difference in women in the two countries from the British Isles which could not be totally explained by the socio-demographic factors included in this study.

Seasonality, negative life events and social support in a community sample.

Abstract: Background Seasonal affective disorder (SAD) is now a well-described form of depressive disorder. However, relatively little research has focused upon psychosocial factors and SAD. Aims To determine the association between demographic/psychosocial factors and increased reported seasonal patterns of mood disorder (seasonality) and SAD in a community sample in the UK. Method A total of 1250 people, aged between 18 and 64 years, randomly selected from a primary care database were screened for SAD. Those above cut-off underwent diagnostic interview and completed several self-report questionnaires. Multivariate analysis was conducted to determine which variables were significantly associated with increased seasonality. Results Four factors (having experienced more numerous negative life events, having low levels of social support, being a woman and being non-native) were predictive of higher seasonality. Being a woman was predictive of being diagnosed as a case of SAD. Conclusions A new association has been identified between increased seasonality, negative life events and social support. Future research should assess the psychosocial causes or consequences of SAD while continuing to examine the biology of the condition.

A 'real puzzle': the views of patients with epilepsy about the organisation of care

Abstract: Background Little is known about how individuals who have a diagnosis of epilepsy have experienced healthcare services or their views about how they should best be organised to meet their ongoing needs. Methods Focus group interviews. Individuals with epilepsy were identified in 5 practices in Wales: 90 were invited, 40 confirmed attendance and 19 individuals attended interviews in 5 groups of size 6, 5, 4, 3 and 1 (Table 2). Inclusion criteria: individuals with a confirmed diagnosis of epilepsy, aged between 18–65. The exclusion criteria were learning disability or an inability to travel to interview locations. Results The individuals in these group interviews were not 'epilepsy activists' yet they remained critical in extended discussions about the services encountered during their patient careers, wanting more information and advice about how to adapt to problems, particularly after initial diagnosis, more involvement in decision making, rapid access to expertise, preferably local, and improved communication between clinicians. A central concern was the tendency for concerns to be silenced, either overtly, or covertly by perceived haste, so that they felt marginalised, despite their own claims to own expert personal knowledge. Conclusions Users of existing services for epilepsy are critical of current systems, especially the lack of attention given to providing information, psychosocial support and the wishes of patients to participate in decision making. Any reorganisation of services for individuals with epilepsy should take into account these perceived problems as well as try to reconcile the tension between the distant and difficult to access expertise of specialists and the local but unconfident support of generalists. The potential benefit of harnessing information technology to allow better liaison should be investigated.

Welsh women's comments about breast problems and the care given: a qualitative study in the community.

Abstract: The aim of this study was to undertake a systematic analysis, using qualitative software, of the free text comments from a postal survey exploring women’s experiences of breast symptoms, their expectations of treatment, knowledge of breast cancer risk factors and perceptions of risk, in 34 group general practices in South Wales. The 959 women who returned the questionnaire, out of 1126 (response rate 85%), comprised 497 women who consulted their general practitioner (GP) with a new breast symptom during the baseline data collection period and 462 controls who had not. When the survey was conducted the researchers did not know whether these women had cancer or had previously been treated for it. One-third (33.1%) of those returning the survey (n=318) wrote comments. Compared to the rest, they were significantly more likely to have consulted their GP for a new breast symptom and to have stayed on at school and/or gone on to more education or training. The majority wrote about their own experience of breast symptoms and/or the care received in primary and secondary settings. The general tone was factual and when evaluation took place positive comments were more frequent than negative ones. Nothing suggested that the respondents had been upset or made more anxious by the preceding questions on such a potentially sensitive topic. Free text comments gathered in surveys can provide valuable data if systematically analysed. Doctors, particularly GPs, can be reassured that more women in this community sample who expressed an opinion on care were positive. The negative comments, however, highlight issues that still need to be addressed in therapeutic relationships.