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 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%).     

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.     

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.     

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.     

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.     

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.     

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.     

Reducing the time before consulting with symptoms of lung cancer: a randomised controlled trial in primary care

Background

Most individuals with lung cancer have symptoms for several months before presenting to their GP. Earlier consulting may improve survival.

Aim

To evaluate whether a theory-based primary care intervention increased timely consulting of individuals with symptoms of lung cancer.

Design and setting

Open randomised controlled trial comparing intervention with usual care in two general practices in north-east Scotland.

Method

Smokers and ex-smokers aged ≥55 years were randomised to receive a behavioural intervention or usual care. The intervention comprised a single nurse consultation at participants’ general practice and a self-help manual. The main outcomes were consultations within target times for individuals with new chest symptoms (≤3 days haemoptysis, ≤3 weeks other symptoms) in the year after the intervention commenced, and intentions about consulting with chest symptoms at 1 and 6 months.

Results

Two hundred and twelve participants were randomised and 206 completed the trial. The consultation rate for new chest symptoms in the intervention group was 1.19 (95% confidence interval [CI] = 0.92 to 1.53; P = 0.18) times higher than in the usual-care group and the proportion of consultations within the target time was 1.11 (95% CI = 0.41 to 3.03; P = 0.83) times higher. One month after the intervention commenced, the intervention group reported intending to consult with chest symptoms 31 days (95% CI = 7 to 54; P = 0.012) earlier than the usual care group, and at 6 months this was 25 days (95% CI = 1.5 to 48; P = 0.037) earlier.

Conclusion

Behavioural intervention in primary care shortened the time individuals at high risk of lung disease intended to take before consulting with new chest symptoms (the secondary outcome of the study), but increases in consultation rates and the proportions of consultations within target times were not statistically significant.     

Effectiveness of a Web-based intervention aimed at healthy dietary and physical activity behavior: a randomized controlled trial about users and usage

Background

Recent studies have shown the potential of Web-based interventions for changing dietary and physical activity (PA) behavior. However, the pathways of these changes are not clear. In addition, nonusage poses a threat to these interventions. Little is known of characteristics of participants that predict usage.

Objective

In this study we investigated the users and effect of the Healthy Weight Assistant (HWA), a Web-based intervention aimed at healthy dietary and PA behavior. We investigated the value of a proposed framework (including social and economic factors, condition-related factors, patient-related factors, reasons for use, and satisfaction) to predict which participants are users and which participants are nonusers. Additionally, we investigated the effectiveness of the HWA on the primary outcomes, self-reported dietary and physical activity behavior.

Methods

Our design was a two-armed randomized controlled trial that compared the HWA with a waiting list control condition. A total of 150 participants were allocated to the waiting list group, and 147 participants were allocated to the intervention group. Online questionnaires were filled out before the intervention period started and after the intervention period of 12 weeks. After the intervention period, respondents in the waiting list group could use the intervention. Objective usage data was obtained from the application itself.

Results

In the intervention group, 64% (81/147) of respondents used the HWA at least once and were categorized as “users.” Of these, 49% (40/81) used the application only once. Increased age and not having a chronic condition increased the odds of having used the HWA (age: beta = 0.04, P = .02; chronic condition: beta = 2.24, P = .003). Within the intervention group, users scored better on dietary behavior and on knowledge about healthy behavior than nonusers (self-reported diet: χ² ₂ = 8.4, P = .02; knowledge: F_1,125 = 4.194, P = .04). Furthermore, users underestimated their behavior more often than nonusers, and nonusers overestimated their behavior more often than users (insight into dietary behavior: χ² ₂ = 8.2, P = .02). Intention-to-treat analyses showed no meaningful significant effects of the intervention. Exploratory analyses of differences between pretest and posttest scores of users, nonusers, and the control group showed that on dietary behavior only the nonusers significantly improved (effect size r = −.23, P = .03), while on physical activity behavior only the users significantly improved (effect size r = −.17, P = .03).

Conclusions

Respondents did not use the application as intended. From the proposed framework, a social and economic factor (age) and a condition-related factor (chronic condition) predicted usage. Moreover, users were healthier and more knowledgeable about healthy behavior than nonusers. We found no apparent effects of the intervention, although exploratory analyses showed that choosing to use or not to use the intervention led to different outcomes. Combined with the differences between groups at baseline, this seems to imply that these groups are truly different and should be treated as separate entities.

Trial registration

Trial ID number: ISRCTN42687923; http://www.controlled-trials.com/ISRCTN42687923/ (Archived by WebCite at http://www.webcitation.org/5xnGmvQ9Y)     

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.     

Effects of an educational peer-group intervention on knowledge about dementia among family caregivers with a Turkish or Moroccan immigrant background: A cluster randomised controlled trial

ObjectiveThe aim of this paper is to examine the effects of an educational peer-group intervention on knowledge about dementia, perceived ability to talk about it, received support and self-perceived pressure from informal care among family caregivers with a Turkish or Moroccan immigrant background who cared for a person with dementia.MethodsThis paper is based on a cluster randomised controlled trial with three measures, including participants who knew or cared for a person with dementia. For the purpose of this study, a selection was made of participants who cared for a person with dementia. Knowledge about dementia, perceived ability to talk about dementia, support received and self-perceived pressure from informal care were assessed inthe intervention and the control condition. Multi-level analyses were conducted to examine the effects.ResultsData for 386 participants was analysed. Improvement in knowledge about dementia over time was significantly greater in the intervention condition than in the control condition. In the intervention condition, there was also a significant increase over time in the support received from home-care staff, which was not found in the control condition. No effects were found on other types of support received, the ability to talk about dementia or the self-perceived pressure from informal care.ConclusionOffering a culturally sensitive educational peer-group education intervention enhances knowledge about dementia and has a small but positive effect on the support received from home-care staff in these groups.Practice ImplicationsOffering peer-group-based education about dementia to family caregivers with Turkish or Moroccan immigrant backgrounds is important for multicultural dementia care.     

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.     

Effectiveness of a Web-based multiple tailored smoking cessation program: a randomized controlled trial among Dutch adult smokers

Background

Distributing a multiple computer-tailored smoking cessation intervention through the Internet has several advantages for both provider and receiver. Most important, a large audience of smokers can be reached while a highly individualized and personal form of feedback can be maintained. However, such a smoking cessation program has yet to be developed and implemented in the Netherlands.

Objective

To investigate the effects of a Web-based multiple computer-tailored smoking cessation program on smoking cessation outcomes in a sample of Dutch adult smokers.

Methods

Smokers were recruited from December 2009 to June 2010 by advertising our study in the mass media and on the Internet. Those interested and motivated to quit smoking within 6 months (N = 1123) were randomly assigned to either the experimental (n = 552) or control group (n = 571). Respondents in the experimental group received the fully automated Web-based smoking cessation program, while respondents in the control group received no intervention. After 6 weeks and after 6 months, we assessed the effect of the intervention on self-reported 24-hour point prevalence abstinence, 7-day point prevalence abstinence, and prolonged abstinence using logistic regression analyses.

Results

Of the 1123 respondents, 449 (40.0%) completed the 6-week follow-up questionnaire and 291 (25.9%) completed the 6-month follow-up questionnaire. We used a negative scenario to replace missing values. That is, we considered respondents lost to follow-up to still be smoking. The computer-tailored program appeared to have significantly increased 24-hour point prevalence abstinence (odds ratio [OR] 1.85, 95% confidence interval [CI] 1.30–2.65), 7-day point prevalence abstinence (OR 2.17, 95% CI 1.44–3.27), and prolonged abstinence (OR 1.99, 95% CI 1.28–3.09) rates reported after 6 weeks. After 6 months, however, no intervention effects could be identified. Results from complete-case analyses were similar.

Conclusions

The results presented suggest that the Web-based computer-tailored smoking cessation program had a significant effect on abstinence reported after a 6-week period. At the 6-month follow-up, however, no intervention effects could be identified. This might be explained by the replacement of missing values on the primary outcome measures due to attrition using a negative scenario. While results were similar when using a less conservative scenario (ie, complete-case analyses), the results should still be interpreted with caution. Further research should aim at identifying strategies that will prevent high attrition in the first place and, subsequently, to identify the best strategies for dealing with missing data when studies have high attrition rates.

Trial Registration

Dutch Trial Register NTR1351; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1351 (Archived by WebCite at http://www.webcitation.org/67egSTWrz)     

Exploring patients' reasons for declining contact in a cognitive behavioural therapy randomised controlled trial in primary care

Background

The difficulties of recruiting individuals into mental health trials are well documented. Few studies have collected information from those declining to take part in research, in order to understand the reasons behind this decision.

Aim

To explore patients'' reasons for declining to be contacted about a study of the effectiveness of cognitive behavioural therapy as a treatment for depression.

Design and setting

Questionnaire and telephone interview in general practices in England and Scotland.

Method

Patients completed a short questionnaire about their reasons for not taking part in research. Semi-structured telephone interviews were conducted with a purposive sample to further explore reasons for declining.

Results

Of 4552 patients responding to an initial invitation to participate in research involving a talking therapy, 1642 (36%) declined contact. The most commonly selected reasons for declining were that patients did not want to take part in a research study (n = 951) and/or did not want to have a talking therapy (n = 688) (more than one response was possible). Of the decliners, 451 patients agreed to an interview about why they declined. Telephone interviews were completed with 25 patients. Qualitative analysis of the interview data indicated four main themes regarding reasons for non-participation: previous counselling experiences, negative feelings about the therapeutic encounter, perceived ineligibility, and misunderstandings about the research.

Conclusion

Collecting information about those who decline to take part in research provides information on the acceptability of the treatment being studied. It can also highlight concerns and misconceptions about the intervention and research, which can be addressed by researchers or recruiting GPs. This may improve recruitment to studies and thus ultimately increase the evidence base.     

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.     

A randomized, controlled pilot trial of a school intervention for children with sickle cell anemia

OBJECTIVE: To investigate the feasibility and efficacy of a randomized clinical pilot trial comparing routine services (RS) with a school intervention program (SIP) for children with sickle cell anemia (SCA). METHOD: Twenty-four children (ages 8-12 years) with SCA were randomized to RS or SIP. General disease knowledge, consumer satisfaction, self-concept, and school absences were evaluated. RESULTS: Compared with children receiving RS, children and teachers receiving SIP evidenced more accurate information about their disease, and children with SCA had significantly fewer absences. Teachers receiving SIP reported higher consumer satisfaction. CONCLUSIONS: A modest educational curriculum can increase knowledge of SCA, is associated with lower absence rates, and yields high consumer satisfaction ratings.     

Effects of an educational intervention on health-related quality of life among family caregivers of people with dementia with a Turkish or Moroccan immigrant background: Insights from a cluster randomised controlled trial

ObjectiveGaining understanding of the health-related quality of life (HRQL) of family caregivers of people with dementia with Turkish or Moroccan immigrant backgrounds and to examine whether an educational peer group intervention can improve HRQL.MethodsUnderstanding of HRQL and associated variables was obtained by multiple linear regression analyses. The effects of the intervention on HRQL were assessed in multilevel analyses using data collected before the start (baseline), directly after the intervention (one to two weeks after baseline) and three months after the start of the intervention. The intervention (two interactive group sessions) entailed providing information about dementia and care/support options.ResultsAt baseline (n = 319), HRQL was moderately and significantly associated with migration background, gender, self-perceived pressure from informal care and the formal and informal support received (p < .05). The intervention had a small effect on emotional wellbeing directly after the intervention (p < .05) and on perceived general health status three months after (p < .05).ConclusionCulturally sensitive peer group education on dementia and care/support options can to some extent enhance HRQL among family caregivers in the short term.Practice implicationsThe intervention as described in this study is recommended for supporting family caregivers of people with dementia with Turkish or Moroccan backgrounds.