Adjuvant prednisone therapy in pharyngitis: a randomised controlled trial from general practice

BACKGROUND: Acute pharyngitis is a frequent and well-documented complaint in general practice but the associated suffering has remained largely unaddressed in the literature. Evidence, however, from five randomised controlled trials suggests that corticosteroids may be useful in relieving pain and discomfort arising from the condition. AIM: To determine if short-acting oral therapy with prednisone was more effective than placebo in alleviating the suffering from acute pharyngitis in adults in a general practice setting. DESIGN OF STUDY: Randomised placebo-controlled trial. SETTING: General practice in Israel. METHOD: Patients with acute pharyngitis were randomised to receive 60 mg prednisone orally for 1 or 2 days, or identical placebo treatment. The main outcome measures were throat pain, measured by a visual analogue scale at 12, 24, 48 and 72 hours after presentation, time off work, fever, dysphagia, recurrence of symptoms and bacterial recurrence. RESULTS: Patients treated with prednisone experienced more rapid throat pain resolution than those in the placebo group. No adverse effects were reported nor any differences between the two groups regarding either symptom or positive bacterial culture recurrence. CONCLUSION: Short-acting oral steroid therapy is effective for shortening throat pain duration in acute pharyngitis.     

Improving management of hypertension in general practice: a randomised controlled trial of feedback derived from electronic patient data

BACKGROUND: Although absolute risk of death associated with raised blood pressure increases with age, the benefits of treatment are greater in older patients. However, fewer patients in this group are identified, treated, and controlled. AIM: To evaluate the impact of the provision of different levels of feedback on identification, treatment, and control of older patients with hypertension. DESIGN OF STUDY: Randomised controlled trial. SETTING: Fifty-two Scottish general practices. METHOD: Practices were randomly allocated to either control (n = 19), audit only feedback (n = 16), or audit plus risk feedback, prioritising patients by absolute risk (n = 17). Electronic data were extracted from practice computer systems annually from 1999 to 2001 and used to develop feedback. Data were collected for 30 345 patients aged 65-79 years. RESULTS: The majority of known patients with hypertension in each group had an initial blood pressure recorded (control = 89.6%; audit = 80.4%; risk = 96.1%) and this increased over the study period (control = 92.3%; audit = 86.0%; risk = 96.6%). Initially, more than 80% of patients in each group were treated but many were uncontrolled (blood pressure >/=160/ >/=90 mmHg) (control = 41.5%; audit = 41.3%; risk = 36.1%). The numbers of untreated and uncontrolled patients in each group reduced (control = 32.3%; audit = 38.3%; risk = 32.6%). There was some evidence of a significant difference in mean systolic pressure between the audit plus risk and audit only groups: (149.6 versus 152.7 mmHg; P = 0.019) and of significantly greater control in the audit plus risk group compared with the other groups 49.4% (versus audit only = 35.4%; versus control = 46.5%; odds ratio = 1.72 [95% confidence interval = 1.09 to 2.70]; P = 0.019). CONCLUSIONS: Levels of identification, treatment, and control improved in each group. Although there were still significant numbers of patients with uncontrolled hypertension, there is some evidence to suggest that providing patient-specific feedback may have a positive impact on identification and management of hypertension in older people and produce an increase in control.     

Simplified sleep restriction for insomnia in general practice: a randomised controlled trial

Background

Insomnia is common in primary care. Cognitive behavioural therapy for insomnia (CBT-I) is effective but requires more time than is available in the general practice consultation. Sleep restriction is one behavioural component of CBT-I.

Aim

To assess whether simplified sleep restriction (SSR) can be effective in improving sleep in primary insomnia.

Design and setting

Randomised controlled trial of patients in urban general practice settings in Auckland, New Zealand.

Method

Adults with persistent primary insomnia and no mental health or significant comorbidity were eligible. Intervention patients received SSR instructions and sleep hygiene advice. Control patients received sleep hygiene advice alone. Primary outcomes included change in sleep quality at 6 months measured by the Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), and sleep efficiency (SE%). The proportion of participants reaching a predefined ‘insomnia remission’ treatment response was calculated.

Results

Ninety-seven patients were randomised and 94 (97%) completed the study. At 6-month follow-up, SSR participants had improved PSQI scores (6.2 versus 8.4, P<0.001), ISI scores (8.6 versus 11.1, P = 0.001), actigraphy-assessed SE% (difference 2.2%, P = 0.006), and reduced fatigue (difference −2.3 units, P = 0.04), compared with controls. SSR produced higher rates of treatment response (67% [28 out of 42] versus 41% [20 out of 49]); number needed to treat = 4 (95% CI = 2.0 to 19.0). Controlling for age, sex, and severity of insomnia, the adjusted odds ratio for insomnia remission was 2.7 (95% CI = 1.1 to 6.5). There were no significant differences in other outcomes or adverse effects.

Conclusion

SSR is an effective brief intervention in adults with primary insomnia and no comorbidities, suitable for use in general practice.     

Effectiveness of ear syringing in general practice: a randomised controlled trial and patients'' experiences.

BACKGROUND: Ear syringing is a common procedure performed for a variety of symptoms in primary care. Reports of its effectiveness vary considerably and no randomised controlled trials (RCTs) have been performed. AIM: To estimate the effect of ear syringing on hearing thresholds and on symptoms leading to ear syringing in general practice. DESIGN OF STUDY: Randomised single-blind controlled trial. Before-and-after self-assessments of symptoms. SETTING: Patients from three general practices in the Bristol area attending twice-weekly clinics dedicated to ear syringing over a 12-week period. METHOD: Patients were randomly assigned to have their hearing tested before and after ear syringing, or twice before ear syringing. Changes in hearing threshold were measured by pure tone audiometry (PTA). All patients completed sef-assessment forms of symptoms using Likert scales before, and one week after, ear syringing. RESULTS: Hearing threshold improved by 10 dB or more in 34% (95% confidence interval [CI] = 21% to 47%) of the intervention group and 1.6% of control group (number needed to treat = 3.1, 95% CI = 2.2 to 5.2, P<0.001). The levels of improvement in the intervention group ranged between 15 dB and 36 dB. The symptoms that most commonly improved included hearing on the phone, pain, a feeling of blocked ears, and hearing one-to-one. There was a strong relationship between the change thresholds, as measure using PTA, and self-reports of hearing improvement. Secondary analysis was unable to identify predictors of objectively measured improvement. CONCLUSION: Ear syringing improved hearing threshold in a substantial proportion of patients. An even larger proportion reported an improvement in symptoms. It was not possible to predict which patients would benefit.     

Specialist treatment versus self-help for bulimia nervosa: a randomised controlled trial in general practice.

BACKGROUND: Little is known about general practice management of patients with eating disorders. AIM: To compare the effectiveness of a general practice-based, self-help approach to the treatment of bulimia nervosa with that of specialist outpatient treatment. DESIGN OF STUDY: A prospective, parallel group, randomised controlled trial. SETTING: General practices and specialist eating disorder clinics in London. METHOD: Patients were recruited from general practitioner (GP) referrals to specialist eating disorder clinics. Thirty-four patients were randomised to receive the self-help intervention in general practice and thirty-four were randomised to the clinic intervention. Patients randomised to the self-help arm of the trial worked through a manual based on cognitive behaviour principles, while keeping in contact with their GPs. Those randomised to receive specialist treatment were managed in the specialist clinic to which they had been referred. The main outcome measure was the Bulimic Investigatory Test Edinburgh score, assessed at baseline and at six and nine months. Secondary measures were eating pathology, depression, and social adjustment. RESULTS: A total of 74% and 80% of patients were followed up at six and nine months respectively. An intention-to-treat analysis revealed that, while bulimic symptoms declined in both groups over time, there was no significant difference in outcome between the two groups. CONCLUSION: The findings lend support to the idea that patients with bulimia nervosa can be treated in general practice and that this approach warrants further investigation.     

Boosting uptake of influenza immunisation: a randomised controlled trial of telephone appointing in general practice.

BACKGROUND: Immunisation against influenza is an effective intervention that reduces serologically confirmed cases by between 60% and 70%. Almost all influenza immunisation in the UK is done within general practice. Current evidence on the effectiveness of patient reminders for all types of immunisation programmes is largely based on North American studies. AIM: To determine whether telephone appointments offered bygeneral practice receptionists increase the uptake of irfluenza immunisation among the registered population aged over 65 years in east London practices. DESIGN OF STUDY: Randomised controlled trial. SETTING: Three research general practices within the East London and Essex network of researchers (ELENoR). METHOD: Participants were 1,820 low-risk patients aged 65 to 74 years who had not previously been in a recall system for influenza immunisation at their general practice. The intervention, during October 2000, was a telephone call from the practice receptionist to intervention group households, offering an appointment for influenza immunisation at a nurse-run. clinic Main outcome measures were the numbers of individuals in each group receiving immunisation, and practice costs of a telephone-appointing programme. RESULTS: intention to treat analysis showed an immunisation rate in the control group of 44%, compared with 50% in the intervention group (odds ratio = 1.29, 95% confidence interval = 1.03 to 1.63). Of the patients making a telephone appointment, 88% recieved immunisation, while 22% of those not wanting an appointment went on to be immunised. In the controlgroup, income generated was 11.35 pounds per immunisation, for each additional immunisation in the intervention group the income was 5.20 pounds. The 'number needed to telephone' was 17. CONCLUSION: Uptake of influenza immunisation among the low-risk older population in inner-city areas can be boosted by around 6% using a simple intervention by receptionists. Immunisation rates in this low-risk group fell well short of the 60% government target. Improving immunisation rates will require a sustained public health campaign. Retaining the item-of-service payments to practices should support costs of practice-based interventions.     

A counsellor in general practice: a one-year survey

A counsellor was included within the professional staff of a practice of 11,000 patients cared for by five partners. A review of her work over a 12-month period is described. Eighty-seven patients were counselled in 197 sessions. Thirty-five per cent of first appointments and 22 per cent of subsequent appointments were not kept. The problems dealt with most frequently were anxiety and stress, marital troubles and abortion. Patients perceived the service as giving relief by allowing them to talk and helping them to work out their problems.     

Evaluating a mental health assessment for older people with depressive symptoms in general practice: a randomised controlled trial.

BACKGROUND: There is a lack of evidence on the most effective primary care management of older people with minor depression. AIM: To evaluate a follow-up assessment by the community mental health team (CMHT) for older people with depressive symptoms identified by practice nurses at a health check for people over the age of 75 years. DESIGN OF STUDY: A pragmatic randomised controlled trial. SETTING: A single large general practice in Leicestershire. METHOD: Patients receiving a health check administered by a practice nurse and scoring 5 or more on the 15-item Geriatric Depression Scale (GDS15) were randomised to either follow-up by the CMHT or routine general practitioner (GP) care. The GDS15 score was measured at the subsequent health check 18 months later. RESULTS: Forty-seven patients were randomised to CMHT assessment and 46 to routine GP care. Uptake of the intervention was 72% (n = 34). At the follow-up health check a greater proportion of the control group had improved GDS15 scores (P = 0.08). Following assessment, the CMHT recommended their further involvement in the care of 12 patients and this was authorised by patients' GPs in six cases. CONCLUSIONS: A follow-up mental health assessment by a member of the local CMHT was not effective in improving outcomes for mildly depressed older people. Other than random error possible reasons for this include the length of follow-up and a failure to meet raised expectations among the intervention group. If complex referral procedures do not improve outcomes for this group, then specialist community services should play a more prominent part in the training of practice staff to care for their depressed older patients.     

The effectiveness of a treatment protocol for male lower urinary tract symptoms in general practice: a practical randomised controlled trial

BACKGROUND: Randomised controlled trials have shown the efficacy of several treatment modalities for lower urinary tract symptoms (LUTS) in selected populations. The effectiveness in daily practice has hardly been investigated, especially in primary care and is dependent on choices between all possible treatment options and best investigated in a comprehensive study, including all treatment modalities (watchful waiting, alpha-blockers, 5-alpha-reductase inhibitors, and surgery). AIM: Assessment of the effectiveness of a comprehensive treatment protocol for LUTS in primary care. DESIGN OF STUDY: Randomised controlled trial. SETTING: Fourteen general practices in the Netherlands. METHOD: Intervention: treatment protocol based on a formalised expert opinion. Control condition: usual care. Study population: 208 subjects with moderate to severe LUTS (IPSS > or =8, median = 13). OUTCOME MEASURES: symptom severity (IPSS [International Prostate Symptom Score]), bother score (Dan-PSS [Danish Prostate Symptom Score]), and maximum urinary flow (Q(max)); incidence of acute urinary retention and urinary tract infections. RESULTS: In the intervention group markedly more subjects used an alpha-blocker at end of follow-up than in the usual care group (24% versus 6%). No significant differences were found between intervention and control group in IPSS, Q(max) or Dan-PSS. CONCLUSION: alpha-blockers and watchful waiting are the most frequent treatment modalities for LUTS in primary care. Our study showed no evidence that a protocol using well-defined indications for all possible treatment modalities based on a formalised expert opinion procedure has added value. Based on our results, we cannot recommend a broadening of the indication for alpha-blockers, which, however, seems to be the current trend.     

Clinical psychology in general practice: a controlled trial evaluation

A controlled trial study is described in which 50 consecutive potential referrals for psychological treatment from one general practice were randomly allocated either to behavioural treatment or no-treatment conditions. Treatment-group patients received treatment from a clinical psychologist working within the practice; the control-group patients continued to be managed by their general practitioner. The patients' use of NHS resources was assessed during the treatment period (or its equivalent for the control group) and at a follow-up comparison point, when the patients' subjective ratings of their progress were also obtained. Between referral and the end of treatment the treated group received significantly less psychotropic medication than the control group. This difference was not, however, maintained at the longer-term follow-up. No differences in general practice consultation rates, in the subjective ratings of psychological distress, in control orientation or life satisfaction were found between the two groups, but the level of patient satisfaction was high. Implications for the design of future studies and for psychological health care delivery systems are discussed.     

Providing general practice needs-based care for carers of people with advanced cancer: a randomised controlled trial

Background

Carers of patients with advanced cancer often have health and psychosocial needs, which are frequently overlooked.

Aim

To meet the needs of carers through a GP consultation directed by a self-completed carer needs checklist.

Design and setting

Randomised controlled trial in general practice with recruitment through specialist oncology clinics, in Brisbane, Australia.

Method

Intervention was (a) carer–GP consultations directed by a self-completed checklist of needs at baseline and 3 months; and (b) a GP-Toolkit to assist GPs to address carer-identified needs. Control group received usual care. Outcome measures were intensity of needs, anxiety and depression, and quality of life.

Results

Total recruitment 392. Overall, no significant differences were detected in the number or intensity of need between groups. Compared to controls, intervention participants with baseline clinical anxiety showed improvements in mental wellbeing (P = 0.027), and those with baseline clinical depression had slower development of anxiety (P = 0.044) at 6 months. For those not anxious, physical wellbeing improved at 1 month (P = 0.040). Carers looking after patients with poor functional status had more physical needs (P = 0.037) at 1 month and more psychological and emotional needs at 3 months (P = 0.034). Those caring for less unwell patients showed improved mental wellbeing at 3 months (P = 0.022).

Conclusion

The intervention did not influence the number or intensity of needs reported by carers of people with advanced cancer. There was limited impact in people with pre-existing clinical anxiety and depression. For the carer of those most severely affected by advanced cancer, it drew attention to the needs arising from the caregiving role.     

Self-help materials for anxiety: a randomized controlled trial in general practice.

The efficacy of a self-help package in treating chronic anxiety was evaluated in a randomized controlled trial in which the intervention group received self-help materials in the form of an audiotape and booklet, in addition to their current treatment. The intervention was successful in terms of mean depression scores (P = 0.01), anxiety scores (P = 0.04) and general health questionnaire scores (P = 0.02) which were significantly lower for the intervention group than for the controls. In addition, the depression scores fell faster for the intervention group than for the controls. The overall mean reduction in three months in adjusted depression scores was approximately two points greater for the intervention group than for the controls (P = 0.02). Clinicians welcomed the package as a valuable addition to the therapies available for managing chronic anxiety problems. Further studies should include larger sample sizes, taking into account the non-response to postal questionnaires over time.     

Does eating yogurt prevent antibiotic-associated diarrhoea?: A placebo-controlled randomised controlled trial in general practice

BACKGROUND: Probiotic capsules have been shown to reduce the incidence of antibiotic-associated diarrhoea in a number of settings. If probiotic yogurt were equally efficacious then it would provide a simple and cost-effective means of preventing antibiotic-associated diarrhoea. AIM: To investigate whether eating live bio yogurt at the time of taking oral antibiotics can prevent antibiotic-associated diarrhoea. DESIGN OF STUDY: This study was a three-arm (bio yogurt, commercial yogurt, no yogurt) randomised controlled trial with double blinding between the two yogurt arms. SETTING: A single primary care general practice surgery in Hingham, Norfolk. The study population included all ages except babies. METHOD: Patients aged over 1 year who required a 1-week course of antibiotics were included in the study. There was complete follow up for 369 patients. The intervention was the consumption of 150 ml of live strawberry-flavoured yogurt for 12 days, starting on the first day of taking the antibiotic. Diarrhoea was defined as 'three or more loose stools per day over at least 2 consecutive days' within 12 days of starting the antibiotics. RESULTS: Of the 120 patients in the no-yogurt group, 17 (14%, 95% confidence interval [CI] = 9.0 to 21.5) developed diarrhoea. Of the 118 given commercial yogurt, 13 (11%, 95% CI = 6.6 to 17.9) developed diarrhoea; nine of the 131 patients (7%; 95% CI = 3.7 to 12.5) given bio yogurt developed diarrhoea (P = 0.17). CONCLUSION: Overall, this study failed to demonstrate that yogurt has any effect on antibiotic-associated diarrhoea.     

Effectiveness of an education programme by a general practice assistant for asthma and COPD patients: results from a randomised controlled trial

In this study a randomised controlled trial was carried out to investigate the effectiveness of an education programme for patients with asthma or chronic obstructive pulmonary disease (COPD). All asthma and COPD patients using medication and experiencing pulmonary symptoms were randomly assigned to the intervention (n=139) or usual-care group (n=137). The intervention consisted of taylor-made education conducted by a general practice assistant and focussing on a patients' technical skills and coping with the disease. Measurements took place at baseline, and after 1 and 2 years of follow-up. After 1 and 2 years the inhalation technique was significantly better in the intervention group compared to the usual-care group. No significant differences were observed regarding disease symptoms, health related quality of life, compliance, smoking cessation, self-efficacy, and coping. The results only support the implementation of the intervention regarding the technical skills (inhalation technique). However, given the importance of improvement of patients' coping and the need for more efficient care, we recommend further exploration of the possibilities of a more structured and intensive education programme.     

Promoting physical activity in older people in general practice: ProAct65+ cluster randomised controlled trial

Background

Regular physical activity reduces falls, hip fractures, and all-cause mortality, but physical activity levels are low in older age groups.

Aim

To evaluate two exercise programmes promoting physical activity among older people.

Design and setting

Pragmatic three-arm, parallel-design cluster randomised controlled trial involving 1256 people aged ≥65 years (of 20 507 invited) recruited from 43 general practices in London, Nottingham, and Derby.

Method

Practices were randomised to the class-based Falls Management Exercise programme (FaME), the home-based Otago Exercise Program (OEP), or usual care. The primary outcome was the proportion reaching the recommended physical activity target 12 months post-intervention. Secondary outcomes included falls, quality of life, balance confidence, and costs.

Results

In total, 49% of FaME participants reached the physical activity target compared with 38% for usual care (adjusted odds ratio 1.78, 95% confidence interval [CI] =1.11 to 2.87, P = 0.02). Differences between FaME and usual care persisted 24 months after intervention. There was no significant difference comparing those in the OEP (43% reaching target at 12 months) and usual-care arms. Participants in the FaME arm added around 15 minutes of moderate-to-vigorous physical activity per day to their baseline level; this group also had a significantly lower rate of falls (incident rate ratio 0.74, 95% CI = 0.55 to 0.99, P = 0.042). Balance confidence was significantly improved in both intervention arms. The mean cost per extra person achieving the physical activity target was £1740. Attrition and rates of adverse reactions were similar.

Conclusion

The FaME programme increases self-reported physical activity for at least 12 months post-intervention and reduces falls in people aged ≥65 years, but uptake is low. There was no statistically significant difference in reaching the target, or in falls, between the OEP and usual-care arms.     

Hepatitis C infection among injecting drug users in general practice: a cluster randomised controlled trial of clinical guidelines'' implementation

BACKGROUND: Hepatitis C is a common infection among injecting drug users and has important implications for general practice. Although several clinical guidelines concerning the infection have been published, their effectiveness has yet to be tested. AIM: To assess the effectiveness of a general practice-based complex intervention to support the implementation of clinical guidelines for hepatitis C management among current or former drug users attending general practice. DESIGN OF STUDY: Cluster randomised controlled trial. SETTING: General practices in the Eastern Regional Health Authority area of Ireland. METHOD: Twenty-six practices were randomly allocated within strata to receive the intervention under study or to provide care as usual for a period of 6 months. There was screening for patients attending general practice for methadone maintenance treatment for hepatitis C and referral of anti-HCV antibody positive patients to a specialist hepatology department for assessment. RESULTS: At study completion, patients in the intervention group were significantly more likely to have been screened for hepatitis C than those in the control group, odds ratio adjusted for clustering 3.76 (95% confidence interval [CI] = 1.3 to 11.3) and this association remained significant after adjusting for other potentially confounding variables, using multiple logistic regression, with the odds ratio adjusted for clustering 4.53 (95% CI = 1.39 to 14.78). Although anti-HCV antibody positive patients in the intervention group were more likely to have been referred to a hepatology clinic, this was not statistically significant (P = 0.06). CONCLUSION: General practice has an important role in the care of people at risk of hepatitis C and when appropriately supported can effectively implement current best practice.     

Study protocol for a pragmatic randomised controlled trial in general practice investigating the effectiveness of acupuncture against migraine

Background

Migraine is a chronic neurologic disease that can severely affect the patient's quality of life. Although in recent years many randomised studies have been carried out to investigate the effectiveness of acupuncture as a treatment for migraine, it remains a controversial issue. Our aim is to determine whether acupuncture, applied under real conditions of clinical practice in the area of primary healthcare, is more effective than conventional treatment.

Methods/Design

The design consists of a pragmatic multi-centre, three-armed randomised controlled trial, complemented with an economic evaluation of the results achieved, comparing the effectiveness of verum acupuncture with sham acupuncture, and with a control group receiving normal care only. Patients eligible for inclusion will be those presenting in general practice with migraine and for whom their General Practitioner (GP) is considering referral for acupuncture. Sampling will be by consecutive selection, and by randomised allocation to the three branches of the study, in a centralised way following a 1:1:1 distribution (verum acupuncture; sham acupuncture; conventional treatment). Secondly, one patient in three will be randomly selected from each of the acupuncture (verum or sham) groups for a brain perfusion study (by single photon emission tomography). The treatment with verum acupuncture will consist of 8 treatment sessions, once a week, at points selected individually by the acupuncturist. The sham acupuncture group will receive 8 sessions, one per week, with treatment being applied at non-acupuncture points in the dorsal and lumbar regions, using the minimal puncture technique. The control group will be given conventional treatment, as will the other two groups.

Discussion

This trial will contribute to available evidence on acupuncture for the treatment of migraine. The primary endpoint is the difference in the number of days with migraine among the three groups, between the baseline period (the 4 weeks prior to the start of treatment) and the period from weeks 9 to 12. As a secondary aspect, we shall record the index of laterality and the percentage of change in the mean count per pixel in each region of interest measured by the brain perfusion tomography, performed on a subsample of the patients within the real and sham acupuncture groups.

Trial registration

Current Controlled Trials ISRCTN98703707.     

The Hawthorne Effect: a randomised,controlled trial

Background  

The 'Hawthorne Effect' may be an important factor affecting the generalisability of clinical research to routine practice, but has been little studied. Hawthorne Effects have been reported in previous clinical trials in dementia but to our knowledge, no attempt has been made to quantify them. Our aim was to compare minimal follow-up to intensive follow-up in participants in a placebo controlled trial of Ginkgo biloba for treating mild-moderate dementia.     

Treatment of anxiety disorders in primary care practice a randomised controlled trial

BACKGROUND: Anxiety disorders are prevalent in primary care. Psychological treatment is effective but time-consuming, and there are waiting lists for secondary care. Interest has therefore grown in developing guidelines for treatment that would be feasible in primary care. AIM: To compare the effectiveness and feasibility of guided self-help, the Anxiety Disorder Guidelines of the Netherlands College of General Practitioners and cognitive behavioural therapy (CBT). DESIGN OF STUDY: Randomised controlled study lasting 12 weeks with follow-up at 3 and 9 months for primary care patients with panic disorder and/or generalised anxiety disorder. SETTING: The first two forms of treatment were carried out by 46 GPs who were randomly assigned to one or the other form. CBT was carried out by cognitive behaviour therapists in a psychiatric outpatient clinic. METHOD: Participants (n = 154) were randomly assigned to one of the three forms of treatment. The main outcome measure used was the state subscale of the Spielberger Anxiety Inventory. RESULTS: All three forms of treatment gave significant improvement between pre-test and post-test, and this improvement remained stable between post-test and the follow-ups. The results obtained with the three treatment forms did not differ significantly over time. The feasibility of the Anxiety Disorder Guidelines was low compared with that of guided self-help. CONCLUSION: Our results indicate that primary care patients with prevalent anxiety disorders for whom the GP does not find referral necessary can be adequately treated by the GP. Psychiatric outpatient clinic referral does not give superior results. Guided self-help is easier for the GP to carry out than a less highly-structured treatment like that laid down in the Anxiety Disorder Guidelines.     

Exploring the mechanisms of change in the chronic disease self-management programme: secondary analysis of data from a randomised controlled trial

Objective

The Chronic Disease Self-Management Programme (CDSMP) has been shown to be clinically and cost effective; however the specific mechanisms by which benefits are achieved are not well understood. We investigate what aspects of the course are associated with different outcomes.

Methods

Post-hoc analysis of data from participants in a randomised controlled trial of the CDSMP using evaluations after 6 months for all patients and longer term outcomes at 12 months for a sub-set of patients. Data were analysed using univariate and multivariate regressions.

Results

All course quality variables apart from the venue predicted satisfaction with CDSMP. The best predictors were ratings of the group process and course content. Group process was also significantly associated with self-care behaviour and long-term group outcomes (such as maintaining contact). Few associations between course ratings and patient health outcomes were found.

Conclusion

The most consistent predictor of CDSMP outcomes was the rating of the group process, highlighting the importance of group dynamics, however the complexity of mechanisms by which the CDSMP works cautions against giving primacy to any single factor.

Practice implications

Taking measures to ensure group processes are of high quality and effective within CDSMP are important in maximising patient satisfaction and self-care behaviour change.