Cost-effectiveness of shared pharmaceutical care for older patients: RESPECT trial findings

Background

Pharmaceutical care serves as a collaborative model for medication review. Its use is advocated for older patients, although its cost-effectiveness is unknown. Although the accompanying article on clinical effectiveness from the RESPECT (Randomised Evaluation of Shared Prescribing for Elderly people in the Community over Time) trial finds no statistically significant impact on prescribing for older patients undergoing pharmaceutical care, economic evaluations are based on an estimation, rather than hypothesis testing.

Aim

To evaluate the cost-effectiveness of pharmaceutical care for older people compared with usual care, according to National Institute for Health and Clinical Excellence (NICE) reference case standards.

Methods

An economic evaluation was undertaken in which NICE reference case standards were applied to data collected in the RESPECT trial.

Results

On average, pharmaceutical care is estimated to cost an incremental £10 000 per additional quality-adjusted life year (QALY). If the NHS''s cost-effectiveness threshold is between £20 000 and £30 000 per extra QALY, then the results indicate that pharmaceutical care is cost-effective despite a lack of statistical significance to this effect. However, the statistical uncertainty surrounding the estimates implies that the probability that pharmaceutical care is not cost-effective lies between 0.22 and 0.19. Although results are not sensitive to assumptions about costs, they differ between subgroups: in patients aged >75 years pharmaceutical care appears more cost-effective for those who are younger or on fewer repeat medications.

Conclusion

Although pharmaceutical care is estimated to be cost-effective in the UK, the results are uncertain and further research into its long-term benefits may be worthwhile.     

Successful GP intervention with frequent attenders in primary care: randomised controlled trial.

BACKGROUND: Frequent attenders to GP clinics can place an unnecessary burden on primary care. Interventions to reduce frequent attendance have had mixed results. AIM: To assess the effectiveness of a GP intervention to reduce frequent-attender consultations. DESIGN OF STUDY: Randomised controlled trial with frequent attenders divided into an intervention group and two control groups (one control group was seen by GPs also providing care to patients undergoing the intervention). SETTING: A health centre in southern Spain. METHOD: Six GPs and 209 randomly-selected frequent attenders participated. Three GPs were randomly allocated to perform the new intervention: of the 137 frequent attenders registered with these three GPs, 66 were randomly allocated to receive the intervention (IG) and 71 to a usual care control group (CG2). The other three GPs offered usual care to the other 72 frequent attenders (CG1). The main outcome measure was the total number of consultations 1 year post-intervention. Baseline measurements were recorded of sociodemographic characteristics, provider-user interface, chronic illnesses, and psychosocial variables. GPs allocated to the new intervention received 15 hours' training which incorporated biopsychosocial, organisational, and relational approaches. After 1 year of follow-up frequent attenders were contacted. An intention-to-treat analysis was used. RESULTS: A multilevel model was built with three factors: time, patient, and doctor. After adjusting for covariates, the mean number of visits at 1 year in IG was 13.10 (95% confidence interval [CI]=11.39 to 14.94); in the CG1 group was 19.37 (95% CI=17.31 to 21.55); and in the CG2 group this was 16.72 (95% CI=4.84 to 18.72). CONCLUSION: The new intervention with GPs resulted in a significant and relevant reduction in frequent-attender consultations. Although further trials are needed, this intervention is recommended to GPs interested in reducing consultations by their frequent attenders.     

Effectiveness of a smartphone application to promote physical activity in primary care: the SMART MOVE randomised controlled trial

Background

Physical inactivity is a major, potentially modifiable, risk factor for cardiovascular disease, cancer, and other chronic diseases. Effective, simple, and generalisable interventions that will increase physical activity in populations are needed.

Aim

To evaluate the effectiveness of a smartphone application (app) to increase physical activity in primary care.

Design and setting

An 8-week, open-label, randomised controlled trial in rural, primary care in the west of Ireland.

Method

Android smartphone users >16 years of age were recruited. All participants were provided with similar physical activity goals and information on the benefits of exercise. The intervention group was provided with a smartphone app and detailed instructions on how to use it to achieve these goals. The primary outcome was change in physical activity, as measured by a daily step count between baseline and follow-up.

Results

A total of 139 patients were referred by their primary care health professional or self-referred. In total, 37 (27%) were screened out and 12 (9%) declined to participate, leaving 90 (65%) patients who were randomised. Of these, 78 provided baseline data (intervention = 37; control = 41) and 77 provided outcome data (intervention = 37; control = 40). The mean daily step count at baseline for intervention and control groups was 4365 and 5138 steps per day respectively. After adjusting, there was evidence of a significant treatment effect (P = 0.009); the difference in mean improvement in daily step count from week 1 to week 8 inclusive was 1029 (95% confidence interval 214 to 1843) steps per day, favouring the intervention. Improvements in physical activity in the intervention group were sustained until the end of the trial.

Conclusion

A simple smartphone app significantly increased physical activity over 8 weeks in a primary care population.     

Open Access Tubal aSsessment for the initial management of infertility in general practice (the OATS trial): a pragmatic cluster randomised controlled trial

Background

GPs investigate approximately half of all infertile couples with semen analysis and endocrine blood tests. For assessment of tubal status, hysterosalpingography (HSG) is recommended as a first-line investigation for women not known to have comorbidities.

Aim

To test whether providing GPs with open access to HSG results in infertile couples progressing to a diagnosis and management plan sooner than with usual management.

Design of study

A pragmatic cluster randomised controlled trial.

Setting

Seventy-one of 173 general practices in north-east England agreed to participate.

Method

A total of 670 infertile couples presented to 33 intervention practices and 25 control practices over a 2-year period. Practices allocated to the intervention group had access to HSG for those infertile women who fulfilled predefined eligibility criteria. The primary outcome measure was the interval between presentation to the GP and the couple receiving a diagnosis and management plan.

Results

An annual incidence of 0.8 couples per 1000 total population equated to each GP seeing an average of one or two infertile couples each year. Open access HSG was used for 9% of all infertile women who presented to the intervention practices during the study period. The time to reach a diagnosis and management plan for all infertile couples presenting was not affected by the availability of open access HSG (Cox regression hazard ratio = 0.9, 95% confidence interval [CI] = 0.7 to 1.1). For couples who reached a diagnosis and management plan, there was a non-significant difference in time to primary outcome for intervention versus control practices (32.5 weeks versus 30.5 weeks, mean difference 2.2 weeks, 95% CI = 1.6 to 6.1 weeks, P = 0.1). The intracluster correlation coefficient was 0.03 across all practices.

Conclusion

Providing GPs with open access to HSG had no effect on the time taken to reach a diagnosis and management plan for couples with infertility.     

A randomised controlled trial to test the feasibility of a collaborative care model for the management of depression in older people

BACKGROUND: Depression is the most common mental health disorder in people aged over 65 years. Late-life depression is associated with chronic illness and disability. AIM: To investigate the feasibility of a collaborative care model for depression in older people in a primary care setting. DESIGN OF STUDY: Randomised controlled trial with 16-weeks follow up. SETTING: A primary care trust in Manchester. METHOD: Participants were 105 people aged 60 years or older who scored 5 or more on the Geriatric Depression Scale; 53 were randomly allocated to an intervention group and 52 to a usual care group. The intervention group received care managed by a community psychiatric nurse who delivered an intervention comprising a facilitated self-help programme with close liaison with primary care professionals and old-age psychiatry according to a defined protocol. The usual care group received usual GP care. A nested qualitative study explored the views of the health professionals and patients regarding the acceptability and effectiveness of the intervention. RESULTS: The main outcome measure was recovery from depression. Patients in the intervention group were less likely to suffer from major depressive disorder at follow up compared with usual care (0.32, 95% confidence = interval = 0.11 to 0.93, P = 0.036). The qualitative component of the study demonstrated the acceptability of the intervention to patients. CONCLUSION: A model of collaborative care for older people with depression, used in a primary care setting with a facilitated self-help intervention is more effective than usual GP care. This study demonstrates that the implementation of a collaborative care model is feasible in UK primary care and that the intervention is effective and acceptable to patients.     

Amoxicillin for acute lower respiratory tract infection in primary care: subgroup analysis of potential high-risk groups

Background

Antibiotics are of limited overall clinical benefit for uncomplicated lower respiratory tract infection (LRTI) but there is uncertainty about their effectiveness for patients with features associated with higher levels of antibiotic prescribing.

Aim

To estimate the benefits and harms of antibiotics for acute LRTI among those producing coloured sputum, smokers, those with fever or prior comorbidities, and longer duration of prior illness.

Design and setting

Secondary analysis of a randomised controlled trial of antibiotic placebo for acute LRTI in primary care.

Method

Two thousand and sixty-one adults with acute LRTI, where pneumonia was not suspected clinically, were given amoxicillin or matching placebo. The duration of symptoms, rated moderately bad or worse (primary outcome), symptom severity on days 2–4 (0–6 scale), and the development of new or worsening symptoms were analysed in pre-specified subgroups of interest. Evidence of differential treatment effectiveness was assessed in prespecified subgroups by interaction terms.

Results

No subgroups were identified that were significantly more likely to benefit from antibiotics in terms of symptom duration or the development of new or worsening symptoms. Those with a history of significant comorbidities experienced a significantly greater reduction in symptom severity between days 2 and 4 (interaction term −0.28, P = 0.003; estimated effect of antibiotics among those with a past history −0.28 [95% confidence interval = −0.44 to −0.11], P = 0.001), equivalent to three people in 10 rating symptoms as a slight rather than a moderately bad problem. For subgroups not specified in advance antibiotics provided a modest reduction in symptom severity for non-smokers and for those with short prior illness duration (<7 days), and a modest reduction in symptom duration for those with short prior illness duration.

Conclusion

There is no clear evidence of clinically meaningful benefit from antibiotics in the studied high-risk groups of patients presenting in general practice with uncomplicated LRTIs where prescribing is highest. Any possible benefit must be balanced against the side-effects and longer-term effects on antibiotic resistance.     

Effectiveness of diclofenac versus paracetamol in knee osteoarthritis: a randomised controlled trial in primary care

Background

The effectiveness of diclofenac versus paracetamol in primary care patients with pain caused by knee osteoarthritis is unclear.

Aim

To assess the effectiveness of diclofenac compared with paracetamol over a period of 2, 4, and 12 weeks in patients with knee osteoarthritis.

Design and setting

Randomised controlled trial in general practice.

Method

There were 104 patients included in the study, they were aged ≥45 years consulting their GP with knee pain caused by knee osteoarthritis. Patients were randomly allocated to diclofenac (n = 52) or paracetamol (n = 52) for at least 2 weeks. Primary outcomes were daily knee pain severity, and knee pain and function measured with the Knee Injury and Osteoarthritis Outcome Score (KOOS).

Results

Over a period of 2- and 4-weeks follow-up, no significant difference in daily knee pain was found between the patient groups: estimated differences of 0.5 (95% CI = −0.2 to 1.3) and −0.2 (95% CI = −1.0 to 0.7), respectively. Over the 12-weeks follow-up, no significant differences were found between both groups for KOOS pain: estimated difference of −2.8 (95% CI = −10.7 to 5.1) and KOOS function of −2.7 (−10.6 to 5.0).

Conclusion

Over a period of 2- and 4-weeks follow-up no significant difference in daily measured knee pain severity was found between primary care patients with knee osteoarthritis taking paracetamol or diclofenac. Also, over a period of 12-weeks follow-up no significant differences were found regarding KOOS pain and KOOS function between both groups. Patients more frequently reported minor adverse events after taking diclofenac (64%) than paracetamol (46%).     

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.     

Depression indicators in a national sample of older community and care home patients: applying the Quality and Outcomes Framework

In a national primary care database sample of older people (≥65 years), 81% (83 588/103 821) of community and 58% (1702/2940) of care home residents with diabetes or heart disease had depression case finding recently recorded; 66% (1418/2145) of community and 22% (26/118) of care home residents with a new depression episode had a depression-severity assessment recorded. Age, sex, and higher care home dementia prevalence did not explain these differences. Case finding and assessment of depression need to be improved in older people, particularly care home residents.     

Quality care provision for older people: an interview study with patients and primary healthcare professionals

Background

In recent years, primary health care for the ageing population has become increasingly complex.

Aim

This study sought to explore the views and needs of healthcare professionals and older patients relating to primary care in order to identify focal areas for improving primary health care for older people.

Design and setting

This research was structured as a mixed interview study with focus groups and individual interviews. Participants were made up of primary healthcare professionals and older patients. Patients were recruited from five elderly care homes in a small city in the southern part of the Netherlands.

Method

All interviews were transcribed verbatim and analysed by two individual researchers applying constant comparative analysis. Data collection proceeded until saturation was reached.

Results

Participants in the study agreed about the need for primary care for older patients, and showed sympathy with one another’s perspectives. They did note, however, a number of obstacles hindering good healthcare provision. The major themes that arose were: ‘autonomy and independence’, ‘organisational barriers’, and ‘professional expertise’. Participants generally noted that it is important to clarify differences in perspectives about good care between patients and healthcare professionals.

Conclusion

Effective primary care intervention for older patients requires mutual understanding of the expectations and goals of all parties involved. There are a number of important requirements, especially accessible patient information in the form of care plans; specialist training for nurses and GPs on complex care and multimorbidity; and training on discussing autonomy, goal setting, and shared care. Further improvement in health care for older people and its evaluation research should focus on these requirements.     

Randomised controlled trial of intensive multifactorial treatment for cardiovascular risk in patients with screen-detected type 2 diabetes: 1-year data from the ADDITION Netherlands study

Background

A growing body of evidence suggests that earlier diagnosis and treatment of diabetes may be beneficial; however, definitive evidence is lacking.

Aim

To evaluate the effectiveness of an intensified multifactorial treatment on cardiovascular risk factors in patients with screen-detected type 2 diabetes.

Design of study

Randomised controlled trial.

Setting

Seventy-nine general practices in the southwestern region of the Netherlands.

Method

In this randomised trial, patients diagnosed with diabetes by screen-detection were assigned to intensified (n = 255) or routine treatment (n = 243), and followed over 1 year. Intensified treatment consisted of pharmacological treatment combined with lifestyle education to achieve haemoglobin A1c (HbA1c) <7.0%, blood pressure <135/85 mmHg, and cholesterol <5.0 mmol/l (4.5 mmol/l if cardiovascular disease was present). Health-related quality of life (HRQoL) was assessed using the Short Form (SF)-36. Analyses were performed using generalised estimating equations models.

Results

Changes in body mass index were 0.2 (routine care) versus −1.4 kg/m² (intensified treatment), P<0.001; systolic blood pressure −19 versus −33 mmHg, P<0.001; diastolic blood pressure −7 versus −12 mmHg, P<0.001; HbA1c −0.9% versus −1.1%, P = 0.03; cholesterol −0.5 versus −1.2 mmol/l, P<0.001; high-density lipoprotein cholesterol 0.1 versus 0.1 mmol/l, P = 0.26; low-density lipoprotein cholesterol −0.5 versus −1.0 mmol/l, P<0.001; triglycerides −0.3 versus −0.4 mmol/l, P = 0.71. No difference in HRQoL between the two groups was reported.

Conclusion

Intensified multifactorial treatment of patients with screen-detected diabetes in general practice reduces cardiovascular risk factor levels significantly without worsening HRQoL.     

Effectiveness of shared decision-making intervention in patients with lumbar degenerative diseases: A randomized controlled trial

ObjectiveTo evaluate the efficacy of shared decision-making (SDM) intervention among patients with lumbar degenerative diseases (LDDs) in terms of decision self-efficacy, control preferences, SDM process, decision satisfaction, and conflict.MethodsA total of 130 outpatients with LDDs recruited from orthopedic or rehabilitation clinics were randomly assigned to the SDM intervention (n = 67) or comparison (n = 63) groups. Patients in the intervention group received decision aids (DAs) with decision coaching and those in controlled group received standard educational materials from a health educator. The primary outcome was decision self-efficacy, and secondary outcomes were control preference, SDM process, conflict, and satisfaction.ResultsThe SDM intervention significantly improved decision self-efficacy (mean difference [MD] = 7.1, 95% confidence interval [CI]: 1.7–12.5, partial η² = 0.05) and reduced conflict (MD = −7.0, 95% CI: −12.2 to −1.9, partial η² = 0.06), especially in patients without family involvement, compared with the health education group. However, no significant between-group differences were observed in other outcomes.ConclusionSDM intervention improved SDM self-efficacy and reduced conflict in patients with LDDs.Practice ImplicationsClinicians can integrate DAs and decision coaching in SDM conversations. SDM intervention seems to engage patients in decision-making, especially those without family involvement.     

Comparison of methadone and buprenorphine for opiate detoxification (LEEDS trial): a randomised controlled trial

Background

Many opiate users require prescribed medication to help them achieve abstinence, commonly taking the form of a detoxification regime. In UK prisons, drug users are nearly universally treated for their opiate use by primary care clinicians, and once released access GP services where 40% of practices now treat drug users. There is a paucity of evidence evaluating methadone and buprenorphine (the two most commonly prescribed agents in the UK) for opiate detoxification.

Aim

To evaluate whether buprenorphine or methadone help to achieve drug abstinence at completion of a reducing regimen for heroin users presenting to UK prison health care for detoxification.

Design

Open-label, pragmatic, randomised controlled trial in three prison primary healthcare departments in the north of England.

Method

Prisoners (n = 306) using illicit opiates were recruited and given daily sublingual buprenorphine or oral methadone, in the context of routine care, over a standard reduced regimen of not more than 20 days. The primary outcome measure was abstinence from illicit opiates at 8 days post detoxification, as indicated by urine test (self-report/clinical notes where urine sample was not feasible). Secondary outcomes were also recorded.

Results

Abstinence was ascertained for 73.7% at 8 days post detoxification (urine sample = 52.6%, self report = 15.2%, clinical notes = 5.9%). There was no statistically significant difference in the odds of achieving abstinence between methadone and buprenorphine (odds ratio [OR] = 1.69; 95% confidence interval [CI] = 0.81 to 3.51; P = 0.163). Abstinence was associated solely with whether or not the participant was still in prison at that time (15.22 times the odds; 95% CI = 4.19 to 55.28). The strongest association for lasting abstinence was abstinence at an earlier time point.

Conclusion

There is equal clinical effectiveness between methadone and buprenorphine in achieving abstinence from opiates at 8 days post detoxification within prison.     

Effectiveness of GP access to magnetic resonance imaging of the knee: a randomised trial

Background

GPs commonly see patients with knee problems. Magnetic resonance imaging (MRI) of the knee is an accurate diagnostic test for meniscus and ligament injuries of the knee, but there is uncertainty about the appropriate use of MRI and when it should enter the diagnostic pathway for patients with these problems.

Aim

To assess the effectiveness of GP referral to early MRI and a provisional orthopaedic appointment, compared with referral to an orthopaedic specialist without prior MRI for patients with continuing knee problems.

Design of study

Pragmatic multicentre randomised trial with two parallel groups.

Setting

A total of 553 patients consulting their GP about a continuing knee problem were recruited from 163 general practices at 11 sites across the UK.

Method

Patients were randomised to MRI within 12 weeks of GP referral including a provisional orthopaedic appointment, or orthopaedic appointment without prior MRI within a maximum of 9 months from GP referral. The primary outcome measures were the Short Form 36-item (SF-36) physical functioning scale and the Knee Quality of Life 26-item Questionnaire (KQoL-26) at 6, 12, and 24 months.

Results

Patients randomised to MRI improved mean SF-36 physical functioning scores by 2.81 (95% confidence interval [CI] = −0.26 to 5.89) more than those referred to orthopaedics (P = 0.072). Patients randomised to MRI improved mean KQoL-26 physical functioning scores by 3.65 (95% CI = 1.03 to 6.28) more than controls (P = 0.007). There were no other significant differences.

Conclusion

GP access to MRI yielded small, but statistically significant, benefits in patients'' knee-related quality of life but non-significant improvements in physical functioning.     

Case finding for chronic obstructive pulmonary disease in primary care: a pilot randomised controlled trial

Background

Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality. However, much of the disease burden remains undiagnosed.

Aim

To compare the yield and cost effectiveness of two COPD case-finding approaches in primary care.

Design and setting

Pilot randomised controlled trial in two general practices in the West Midlands, UK.

Method

A total of 1634 ever-smokers aged 35–79 years with no history of COPD or asthma were randomised into either a ‘targeted’ or ‘opportunistic’ case-finding arm. Respiratory questionnaires were posted to patients in the ‘targeted’ arm and provided to patients in the ‘opportunistic’ arm at routine GP appointments. Those reporting at least one chronic respiratory symptom were invited for spirometry. COPD was defined as pre-bronchodilator forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC)<0.7 and FEV1<80% of predicted. Primary outcomes were the difference in the proportion of patients diagnosed with COPD and the cost per case detected.

Results

Twenty-six per cent (212/815) in the ‘targeted’ and 13.6% (111/819) in the ‘opportunistic’ arm responded to the questionnaire and 78.3% (166/212) and 73.0% (81/111), respectively, reported symptoms; 1.2% (10/815) and 0.7% (6/819) of patients in the ‘targeted’ and ‘opportunistic’ arms were diagnosed with COPD (difference in proportions = 0.5% [95% confidence interval {CI} = –0.5% to 3.08%]). Over a 12-month period, the ‘opportunistic’ case-finding yield could be improved to 1.95% (95% CI = 1.0% to 2.9%). The cost-per case detected was £424.56 in the ‘targeted’ and £242.20 in the ‘opportunistic’ arm.

Conclusion

Opportunistic case finding may be more effective and cost effective than targeting patients with a postal questionnaire alone. A larger randomised controlled trial with adequate sample size is required to test this.     

Supervised exercises for adults with acute lateral ankle sprain: a randomised controlled trial.

BACKGROUND: During the recovery period after acute ankle sprain, it is unclear whether conventional treatment should be supported by supervised exercise. AIM: To evaluate the short- and long-term effectiveness of conventional treatment combined with supervised exercises compared with conventional treatment alone in patients with an acute ankle sprain. DESIGN: Randomised controlled clinical trial. SETTING: A total of 32 Dutch general practices and the hospital emergency department. METHOD: Adults with an acute lateral ankle sprain consulting general practices or the hospital emergency department were allocated to either conventional treatment combined with supervised exercises or conventional treatment alone. Primary outcomes were subjective recovery (0-10 point scale) and the occurrence of a resprain. Measurements were carried out at intake, 4 weeks, 8 weeks, 3 months, and 1 year after injury. Data were analysed using intention-to-treat analyses. RESULTS: A total of 102 patients were enrolled and randomised to either conventional treatment alone or conventional treatment combined with supervised exercise. There was no significant difference between treatment groups concerning subjective recovery or occurrence of resprains after 3 months and 1-year of follow-up. CONCLUSION: Conventional treatment combined with supervised exercises compared to conventional treatment alone during the first year after an acute lateral ankle sprain does not lead to differences in the occurrence of resprains or in subjective recovery.     

The Clinical Effectiveness of Web-Based Cognitive Behavioral Therapy With Face-to-Face Therapist Support for Depressed Primary Care Patients: Randomized Controlled Trial

Background

Most patients with mild to moderate depression receive treatment in primary care, but despite guideline recommendations, structured psychological interventions are infrequently delivered. Research supports the effectiveness of Internet-based treatment for depression; however, few trials have studied the effect of the MoodGYM program plus therapist support. The use of such interventions could improve the delivery of treatment in primary care.

Objective

To evaluate the effectiveness and acceptability of a guided Web-based intervention for mild to moderate depression, which could be suitable for implementation in general practice.

Methods

Participants (N=106) aged between 18 and 65 years were recruited from primary care and randomly allocated to a treatment condition comprising 6 weeks of therapist-assisted Web-based cognitive behavioral therapy (CBT), or to a 6-week delayed treatment condition. The intervention included the Norwegian version of the MoodGYM program, brief face-to-face support from a psychologist, and reminder emails. The primary outcome measure, depression symptoms, was measured by the Beck Depression Inventory-II (BDI-II). Secondary outcome measures included the Beck Anxiety Inventory (BAI), the Hospital Anxiety and Depression Scale (HADS), the Satisfaction with Life Scale (SWLS), and the EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D). All outcomes were based on self-report and were assessed at baseline, postintervention, and at 6-month follow-up.

Results

Postintervention measures were completed by 37 (71%) and 47 (87%) of the 52 participants in the intervention and 54 participants in the delayed treatment group, respectively. Linear mixed-models analyses revealed a significant difference in time trends between the groups for the BDI-II, (P=.002), for HADS depression and anxiety subscales (P<.001 and P=.001, respectively), and for the SWLS (P<.001). No differential group effects were found for the BAI and the EQ-5D. In comparison to the control group, significantly more participants in the intervention group experienced recovery from depression as measured by the BDI-II. Of the 52 participants in the treatment program, 31 (60%) adhered to the program, and overall treatment satisfaction was high. The reduction of depression and anxiety symptoms was largely maintained at 6-month follow-up, and positive gains in life satisfaction were partly maintained.

Conclusions

The intervention combining MoodGYM and brief therapist support can be an effective treatment of depression in a sample of primary care patients. The intervention alleviates depressive symptoms and has a significant positive effect on anxiety symptoms and satisfaction with life. Moderate rates of nonadherence and predominately positive evaluations of the treatment also indicate the acceptability of the intervention. The intervention could potentially be used in a stepped-care approach, but remains to be tested in regular primary health care.

Trial Registration

Australian New Zealand Clinical Trials Registry: ACTRN12610000257066; http://apps.who.int/trialsearch/trial.aspx?trialid=ACTRN12610000257066 (Archived by WebCite at http://www.webcitation.org/6Ie3YhIZa).     

Motivational interviewing for modifying diabetes risk: a randomised controlled trial

BACKGROUND: Around 10-15% of adults aged over 40 years have pre-diabetes, which carries a high risk of progression to type 2 diabetes. Intensive lifestyle intervention reduces progression by as much as 58%. However, the cost and personnel requirements of these interventions are major obstacles to delivery in NHS primary care. AIM: To assess the effectiveness of a low-cost intervention, delivered in primary care by non-NHS staff, to reduce the risk of diabetes through weight loss and physical activity. DESIGN OF STUDY: Pragmatic single-blind randomised controlled trial with researchers and statistician blinded to group allocation. SETTING: UK primary care. METHOD: One-hundred and forty-one participants with a body mass index of 28 kg/m2 or more, but without diabetes or heart disease, received either information leaflets or individual behavioural counselling using motivational interviewing techniques. The intervention was delivered by five counsellors recruited from the local community. The primary outcomes were the proportions of participants meeting predefined targets for weight loss (5%) and moderate physical activity (150 minutes/week) after 6 months. RESULTS: Using intention-to-treat analysis, more people in the intervention group achieved the weight-loss target (24% versus 7% for controls; odds ratio [OR]=3.96; 95% confidence interval [Cl]=1.4 to 11.4; number needed to treat [NNT]=6.1 (95% Cl=4 to 21). The proportion achieving the physical activity target did not increase significantly (38% versus 28% for controls; OR=1.6; 95% Cl=0.7 to 3.8). CONCLUSION: Short-term weight loss, at a level which, if sustained, is clinically meaningful for reducing diabetes risk, is achievable in primary care, without excessive use of NHS monetary or personnel resources.     

Self-management support for moderate-to-severe chronic obstructive pulmonary disease: a pilot randomised controlled trial

Background

Better self management could improve quality of life (QoL) and reduce hospital admissions in chronic obstructive pulmonary disease (COPD), but the best way to promote it remains unclear.

Aim

To explore the feasibility, effectiveness and cost effectiveness of a novel, layperson-led, theoretically driven COPD self-management support programme.

Design and setting

Pilot randomised controlled trial in one UK primary care trust area.

Method

Patients with moderate to severe COPD were identified through primary care and randomised 2:1 to the 7-week-long, group intervention or usual care. Outcomes at baseline, 2, and 6 months included self-reported health, St George’s Respiratory Questionnaire (SGRQ), EuroQol, and exercise.

Results

Forty-four per cent responded to GP invitation, 116 were randomised: mean (standard deviation [SD]) age 69.5 (9.8) years, 46% male, 78% had unscheduled COPD care in the previous year. Forty per cent of intervention patients completed the course; 35% attended no sessions; and 78% participants completed the 6-month follow-up questionnaire. Results suggest that the intervention may increase both QoL (mean EQ-5D change 0.12 (95% confidence interval [CI] = –0.02 to 0.26) higher, intervention versus control) and exercise levels, but not SGRQ score. Economic analyses suggested that with thresholds of £20 000 per quality-adjusted life-year gained, the intervention is likely to be cost-effective.

Conclusion

This intervention has good potential to meet the UK National Institute for Health and Clinical Excellence criteria for cost effectiveness, and further research is warranted. However, to make a substantial impact on COPD self-management, it will also be necessary to explore other ways to enable patients to access self-management education.