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.     

Computerised patient-specific guidelines for management of common mental disorders in primary care: a randomised controlled trial.

BACKGROUND: A large proportion of people with depression and anxiety go unrecognised by their general practitioner (GP). Case-finding does not appear to be effective on its own. AIM: To compare the effectiveness of case-finding followed by computer-generated patient-specific guidelines with usual care for the management of common mental disorders in primary care.Design of study: Individual patient randomised controlled trial. SETTING: Five general practices in Bristol and Cardiff.METHOD: 762 individuals aged >/= 16 years scoring >/= 12 on the Clinical Interview Schedule Revised were randomised. The experimental intervention required participants to complete a computerised psychosocial assessment that generated a report for the GP including patient-specific treatment recommendations. The control patients were treated as usual with access to locally agreed guidelines.RESULTS: Participants' 12-item General Health Questionnaire (GHQ) score dropped irrespective of treatment allocation. The experimental group had a significantly lower GHQ score at 6 weeks, but not at 6 months. Recovery at 6 months was 3% greater among those receiving the experimental intervention (95% confidence interval [CI] = -4 to 10). Treatment was not significantly associated with quality of life or patient satisfaction.CONCLUSION: Only small benefits are likely from using case-finding followed by patient-specific guidelines to improve clinical management of common mental disorders in primary care. However, depression and anxiety are important public health problems so the utility of such systems should be further investigated.     

Radiography for low back pain: a randomised controlled trial and observational study in primary care.

BACKGROUND: Lumbar spine radiography has limited use in diagnosing the cause of acute low back pain. Consensus-based guidelines recommend that lumbar spine x-rays are not used routinely. However there have been no studies of the effect of referral for radiography at first presentation with low back pain in primary care. AIM: To compare short and long-term physical, social, and psychiatric outcomes for patients with low back pain who are referred or not referred for lumbar spine x-ray at first presentation in general practice. DESIGN OF STUDY: A randomised unblinded controlled trial with an observational arm to enable comparisons to be made with patients not recruited to the trial. SETTING: Ninety-four general practices in south London and the South Thames region. METHOD: Patients consulting their general practitioner (GP) with low back pain at first presentation were recruited to a randomised controlled trial (RCT) or to an observational group. Patients in the trial were randomly allocated to immediate referral for x-ray or to no referral. All patients were asked to complete questionnaires initially, and then at six weeks and one year after recruitment. RESULTS: Six hundred and fifty-nine patients were recruited over 26 months: 153 to the randomised trial and 506 to the observational arm. In the RCT referral for x-ray had no effect on physical functioning, pain or disability, but was associated with a small improvement in psychological wellbeing at six weeks and one year. These findings were supported by the observational study in which there were no differences between the groups in physical outcomes after adjusting for length of episode at presentation; however, those referred for x-ray had lower depression scores. CONCLUSIONS: Referral for lumbar spine radiography for first presentation of low back pain in primary care is not associated with improved physical functioning, pain or disability. The possibility of minor psychological improvement should be balanced against the high radiation dose involved.     

A randomised controlled trial of screening for adult hearing loss during preventive health checks.

BACKGROUND: Prophylactic strategies to counter acquired hearing impairment may involve routine audiometric screening of asymptomatic working-age adults attending general practice for regular health checks. AIM: To evaluate the effect of adult hearing screening on subsequent noise exposure and hearing. DESIGN OF STUDY: A randomised controlled population-based study of health checks and health discussions in general practice. SETTING: The project was initiated in the district of Ebeltoft, Aarhus county, Denmark. METHOD: Intervention group participants' hearing thresholds were determined audiometrically at 0.5, 1, 2, 3, and 4 kHz in each ear. Participants were advised to get their ears checked if the average hearing loss exceeded 20 dB hearing level (dBHL) in either ear. Noise avoidance was emphasised when thresholds exceeded 25 dBHL bilaterally at 4 kHz. Follow-up included questionnaires and audiometry. RESULTS: Hearing loss was observed among 18.9% of the study sample at baseline. At the five-year follow-up we recorded no significant differences between the control and the intervention groups regarding subjective or objective hearing, or exposure to occupational noise. However, there was a tendency towards reduction in exposure to leisure noise among intervention participants (P = 0.045). Approximately 20% reported hearing problems; 16.5% reported tinnitus-related complaints; 0.8% used hearing aids; 35.0% reported frequent noise exposure; and occluding wax was suspected in 2.1%. CONCLUSION: Preventive health checks with audiometry did not significantly affect hearing, but leisure noise exposure tended to become less frequent. The poor effect may be ascribed to inadequate audiological counselling or a higher priority to other advice, e.g. on cardiovascular risk or lifestyle.     

Patients with cancer holding their own records: a randomised controlled trial.

BACKGROUND: The burden of cancer care in general practice is increasing. Patient-held records may facilitate effective, coordinated care, but no randomised controlled trials of their use in cancer care have been conducted, and concerns about possible negative effects remain. AIM: To evaluate the use of a supplementary patient-held record in cancer care. METHOD: Six hundred and fifty radiotherapy outpatients with any form of cancer were randomised either to hold a supplementary record or to receive normal care. It was explained to record holders that the supplementary record was intended to improve communication with health professionals and act as an aide memoire. After three months, patients' satisfaction with communication and with participation in their own care were assessed. Global health status, emotional functioning, and cognitive functioning were measured using the European Organization for Research and Treatment of Cancer QLQ-C30 questionnaire. RESULTS: There were no significant differences between groups in any of the outcome measures. Patients in both groups expressed a high level of satisfaction with communication and participation in their care. Mean (SD) scores in the intervention and control groups were: global health status, 66.8 (24.2) and 65.3 (23.7); emotional functioning, 75.0 (24.6) and 77.4 (22.8); cognitive functioning, 84.5 (21.0) and 84.0 (21.3). CONCLUSION: A supplementary patient-held record for radiotherapy outpatients appears to have no effect on satisfaction with communication, participation in care, or quality of life.     

A controlled trial of multiphasic screening.

A clinical controlled trial was designed to determine the impact of Automated Multiphasic Health Testing on morbidity and attitudes. Three strata comprising 574 families (lower-income group enrolled in health maintenance organization, lower-income not enrolled in such a project, and a middle-income group employed by a utility company) were interviewed to obtain information on utilization, morbidity, health status, and attitudes. Sixty percent of adults in each stratum were then screened. All families were interviewed again one year later. The only significant difference found between screened and non-screened subjects was an increase in nights hospitalized for screened subjects. Physicians were interviewed to determine what abnormalities were found and what treatment was required for project and privately referred patients of these physicians. Previously unknown abnormalities prompted retesting for confirmation in only 28 per cent of the cases and even less often led to treatment.     

Improving uptake of influenza vaccination among older people: a randomised controlled trial.

BACKGROUND: The uptake of influenza vaccination among older people is suboptimal. Contact with a doctor or nurse is associated with older people deciding to accept influenza vaccination. AIM: To compare different forms of approach in improving uptake of influenza vaccination among patients aged 75 years and over in primary care. DESIGN OF STUDY: Randomised controlled trial. SETTING: One large rural general practice serving the town and surrounding area of Melton Mowbray, Leicestershire. METHOD: All 2,052 patients aged 75 years and over, registered with the practice and not living in nursing/residential homes or sheltered accommodation, were included in the study. One-third of patients were randomised to receive an offer of influenza vaccination as part of an over-75 health check administered by a practice nurse in the patient's home, and two-thirds of patients were randomised to receive a personal letter of invitation to attend an influenza vaccination clinic held at the surgery. The main outcome measure was uptake of influenza vaccination. RESULTS: Six hundred and eighty patients were randomised to the health check arm of the trial and 1,372 were randomised to receive a personal letter. Of those randomised to the health check arm, 468 received the health check from the nurse. Overall, the difference in influenza vaccination uptake was 6.4% (95% confidence interval [CI] = 2.2% to 10.4%) with 67.9% (n = 932) of those who were sent a personal letter actually receiving the vaccine, compared with 74.3% (n = 505) of those offered a combined health check and influenza vaccination (P = 0.003). CONCLUSION: Combining home-based over- 75 health checks with influenza vaccination can improve uptake among older patients. However this intervention is likely to be costly and its effect on influenza vaccination rates is modest. The difference in uptake is greater among those who do not routinely comeforwardfor vaccination and a more viable option may be to target these patients.     

Teaching a screening musculoskeletal examination: a randomized, controlled trial of different instructional methods.

PURPOSE: To develop and test a program to teach a rapid screening musculoskeletal examination. METHOD: In 1995, 191 medical and physician assistant students were randomized to four intervention groups: written materials only (n = 47), written materials and videotape (n = 46), written materials and small-group sessions facilitated by fourth-year medical students (n = 55), and all three methods (n = 43). Assessments, in the form of a written test and standardized patient examinations, were conducted before the interventions (n = 40 randomly selected students), seven to ten days and again three months after the interventions (n = all 191 students), and 16 months after the interventions (n = 103 students). RESULTS: While the four intervention groups' written test scores were approximately equal, their scores on the standardized patient examination differed significantly. The students taught in small groups demonstrated significantly superior examination skills compared with the students taught with written material or videotape at seven to ten days and retained this relative superiority after three and 16 months (p < .0001). CONCLUSION: Small-group instruction with hands-on supervised practice is superior to more passive instructional methods for teaching musculoskeletal examination skills and can be successfully delivered by trained senior medical student facilitators with minimal direct expenditure of faculty time.     

Giving patients an audiotape of their GP consultation: a randomised controlled trial.

BACKGROUND: Providing patients with an audiotape of their medical consultation has been a relatively common practice in oncology clinics for some years. However, broader generalisability of the technique has yet to be examined. AIMS: To investigate the efficacy of providing patients with an audiotape of their consultation in a general practice setting. DESIGN OF STUDY: Randomised controlled trial: 95 experimental participants, 85 controls. SETTING: Routine surgeries run by two general practitioners (GPs) in two different health centres. METHOD: All patients attending GP appointments were eligible for inclusion. Patients were followed up by telephone 7-10 days later. RESULTS: More than half (61%) of the patients who received a tape listened to it. Among listeners, 64% rated the tape useful or very useful; 24% noticed information not heard in the consultation. Half of listeners (46%) said that their understanding of the consultation improved after listening to the tape. Half of the listeners (48%) shared the tape with others, of whom 71% found sharing helpful or very helpful. However, 21% of those who shared the information with others found this unhelpful or very unhelpful, suggesting that patients may need to be briefed on the potential risks of sharing. At follow-up a week later, it emerged that being given a tape had no effect on adherence with GPs' advice, nor on anxiety about conditions. CONCLUSION: Providing patients with an audiotape of their GP consultation was positively rated by many patients. Although there were no detectable clinical effects at follow-up, the technique merits further evaluation in general practice.     

PHASE: a randomised, controlled trial of supervised self-help cognitive behavioural therapy in primary care.

BACKGROUND: Common mental health problems account for up to 40% of all general practitioner (GP) consultations. Patients have limited access to evidence-based psychological therapies. Cognitive behavioural therapy self-help strategies offer one potential solution. AIM: To determine differences in clinical outcome, patient satisfaction and costs, between a cognitive behavioural-based self-help package facilitated by practice nurses compared to ordinary care by GPs for mild to moderate anxiety and depression. DESIGN OF STUDY: Randomised controlled trial. SETTING: Seventeen primary healthcare teams. METHOD: Patients presenting to their GP with mild to moderate anxiety and/or depression were recruited to the study and randomised to receive either a self-help intervention facilitated by practice nurses or ordinary care. The self-help intervention consisted of up to three appointments: two 1 week apart and a third 3 months later. There were no restrictions on ordinary care. RESULTS: Intention-to-treat analysis showed that patients treated with practice nurse-supported cognitive behavioural therapy self-help attained similar clinical outcomes for similar costs and were more satisfied than patients treated by GPs with ordinary care. On-treatment analysis showed patients receiving the facilitated cognitive behavioural therapy self-help were more likely to be below clinical threshold at 1 month compared to the ordinary care group (odds ratio [OR] = 3.65, 95% confidence interval [CI] = 1.87 to 4.37). This difference was less well marked at 3 months (OR = 1.36, 95% CI = 0.52 to 3.56). CONCLUSION: Facilitated cognitive behavioural self-help may provide a short-term cost-effective clinical benefit for patients with mild to moderate anxiety and depression. This has the potential to help primary care provide a choice of effective psychological as well as pharmacological treatments for mental health problems.     

Recruitment and retention in a multicentre randomised controlled trial in Bell's palsy: A case study

Background  

It is notoriously difficult to recruit patients to randomised controlled trials in primary care. This is particularly true when the disease process under investigation occurs relatively infrequently and must be investigated during a brief time window.     

The economics of employing a counsellor in general practice: analysis of data from a randomised controlled trial.

BACKGROUND: Counselling is currently adopted in many general practices, despite limited evidence of clinical and cost effectiveness. AIM: To compare direct and indirect costs of counsellors and general practitioners (GPs) in providing care to people with emotional problems. METHOD: We carried out a prospective, randomized controlled trial of non-directive counselling and routine general practice care in 14 general practices in north London. Counsellors adhered to a Rogerian model of counselling. The counselling sessions ranged from one to 12 sessions over 12 weeks. As reported elsewhere, there were no differences in clinical outcomes between the two groups. Therefore, we conducted a cost minimisation analysis. We present only the economic outcomes in this paper. Main outcome measures were cost data (service utilisation, travel, and work absence) at baseline, three months, and nine months. RESULTS: One hundred and thirty-six patients with emotional problems, mainly depression, took part. Seventy patients were randomised to the counsellors and 66 to the GPs. The average direct and indirect costs for the counsellor was 162.09 Pounds more per patient after three months compared with costs for the GP group; however, over the following six months the counsellor group was 87.00 Pounds less per patient than the GP group. Over the total nine-month period, the counsellor group remained more expensive per patient. CONCLUSIONS: Referral to counselling is no more clinically effective or expensive than GP care over a nine-month period in terms of direct plus indirect costs. However, further research is needed to establish indirect costs of introducing a counsellor into general practice.     

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.     

Weight-management interventions in primary care: a pilot randomised controlled trial

Background

There is a paucity of randomised controlled trials of weight management in primary care.

Aim

To ascertain the feasibility of a full trial of a nurse-led weight-management programme in general practice.

Design of study

Factorial randomised control trial.

Setting

Primary care, UK.

Method

A total of 123 adults (80.3% women, mean age 47.2 years) with body mass index ≥27 kg/m², recruited from eight practices, were randomised to receive structured lifestyle support (n = 30), structured lifestyle support plus pedometer (n = 31), usual care (n = 31), or usual care plus pedometer (n = 31) for a 12-week period.

Results

A total of 103 participants were successfully followed up. The adjusted mean difference in weight in structured support compared to usual care groups was −2.63 kg (95% confidence interval [CI] = −4.06 to −1.20 kg), and for pedometer compared to no pedometer groups it was −0.11 kg (95% CI = −1.52 to 1.30 kg). One in three participants in the structured-support groups (17/50, 34.0%) lost 5% or more of their initial weight, compared to less than one in five (10/53, 18.9%) in usual-care groups; provision of a pedometer made little difference (14/48, 29.2% pedometer; 13/55, 23.6% no pedometer). Difference in waist circumference change between structured-support and usual-care groups was −1.80 cm (95% CI = −3.39 to −0.20 cm), and between the pedometer and no pedometer groups it was −0.84 cm (95% CI = −2.42 to 0.73 cm). When asked about their experience of study participation, most participants found structured support helpful.

Conclusion

The structured lifestyle support package could make substantial contributions to improving weight-management services. A trial of the intervention in general practice is feasible and practicable.     

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.     

Clinical and cost-effectiveness of a new nurse-led continence service: a randomised controlled trial

BACKGROUND: Continence services in the UK have developed at different rates within differing care models, resulting in scattered and inconsistent services. Consequently, questions remain about the most cost-effective method of delivering these services. AIM: To evaluate the impact of a new service led by a continence nurse practitioner compared with existing primary/secondary care provision for people with urinary incontinence and storage symptoms. DESIGN OF STUDY: Randomised controlled trial with a 3- and 6-month follow-up in men and women (n = 3746) aged 40 years and over living in private households (intervention [n = 2958]; control [n = 788]). SETTING: Leicestershire and Rutland, UK. METHOD: The continence nurse practitioner intervention comprised a continence service provided by specially trained nurses delivering evidence-based interventions using predetermined care pathways. They delivered an 8-week primary intervention package that included advice on diet and fluids; bladder training; pelvic floor awareness and lifestyle advice. The standard care arm comprised access to existing primary care including GP and continence advisory services in the area. Outcome measures were recorded at 3 and 6 months post-randomisation. RESULTS: The percentage of individuals who improved (with at least one symptom alleviated) at 3 months was 59% in the intervention group compared with 48% in the standard care group (difference of 11%, 95% CI = 7 to 16; P<0.001) The percentage of people reporting no symptoms or 'cured' was 25% in the intervention group and 15% in the standard care group (difference of 10%, 95% CI = 6 to 13, P = 0.001). At 6 months the difference was maintained. There was a significant difference in impact scores between the two groups at 3 and 6 months. CONCLUSIONS: The continence nurse practitioner-led intervention reduced the symptoms of incontinence, frequency, urgency and nocturia at 3 and 6 months; impact was reduced; and satisfaction with the new service was high.     

Eliciting patients' concerns: a randomised controlled trial of different approaches by the doctor.

BACKGROUND: Although a 'patient-centred' approach to general practice consultation is widely advocated, there is mixed evidence of its benefits. AIM: To measure the costs and benefits of using a prompt to elicit patients' concerns when they consult for minor illness. DESIGN OF STUDY: An open randomised controlled trial. SETTING: Four training semi-rural general practices in the south- east of the United Kingdom. METHOD: Patients identified during the first part of the consultation as having a self-limiting illness were randomised to a second part of the consultation that was conducted 'as usual' or involved a written prompt to elicit the patient's concerns. After each consultation the doctor noted the diagnosis and the consultation length and the patient self-completed a questionnaire containing measures of satisfaction, enablement and anxiety. RESULTS: One hundred and ten patients were studied. Patients in the elicitation group reported a small but significant increase in the 'professional care' score of the consultation satisfaction questionnaire (88.2 versus 80.9, mean difference = 7.3, 95% confidence interval = 2.0 to 12.6) but no other benefits were detected. Consultations in the elicitation group, however, were longer by about a minute. CONCLUSION: Given the pressures on consultation time in general practice there must be questions about the practical value of eliciting patients' concerns if the benefit of doing so is small and the cost large.