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Results for “Randomised Controlled Trial”

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PubMed2005

Post-licence driver education for the prevention of road traffic crashes: a systematic review of randomised controlled trials.

The effectiveness of post-licence driver education for preventing road traffic crashes was quantified using a systematic review and meta-analyses of randomised controlled trials. Searches of appropriate electronic databases, the Internet and reference lists of relevant papers were conducted. The searches were not restricted by language or publication status. Data were pooled from 21 randomised controlled trials, including over 300,000 full licence-holding drivers of all ages. Nineteen trials reported subsequent traffic offences, with a pooled relative risk of 0.96 (95% confidence interval 0.94, 0.98). Fifteen trials reported traffic crashes with a pooled relative risk of 0.98 (0.96, 1.01). Four trials reported injury crashes with a pooled relative risk of 1.12 (0.88, 1.41). The results provide no evidence that post-licence driver education is effective in preventing road injuries or crashes. Although the results are compatible with a small reduction in the occurrence of traffic crashes, this may be due to selection biases or bias in the included trials.

Accidents, Traffic↗

PubMed1986

Use of a grading system in the evaluation of complications in a randomised controlled trial on cataract surgery. Oxford Cataract Treatment and Evaluation Team (OCTET).

A randomised controlled trial in progress for more than five years assessed 333 eyes by three methods of cataract surgery. These were (A) intracapsular extraction and contact lens usage; (B) intracapsular extraction and implantation of an iris supported lens (Federov I); and (C) extracapsular extraction and implantation of an iridocapsular lens (Binkhorst 2-loop). This paper reports the use of a weighting scale for rank scoring complications which are dissimilar or are mutually exclusive (for example, capsular versus contact lens problems) to allow the use of non-parametric statistics for comparing disparate features. Thus we found that group B did significantly worse in terms of the number and severity of postoperative complications, a trend in accordance with visual results. This method may serve as a useful model for similar studies.

Aged↗

PubMed2002

Prescribed exercise in people with fibromyalgia: parallel group randomised controlled trial.

OBJECTIVES: To evaluate cardiovascular fitness exercise in people with fibromyalgia. DESIGN: Randomised controlled trial. SETTING: Hospital rheumatology outpatients. Group based classes took place at a "healthy living centre." PARTICIPANTS: 132 patients with fibromyalgia. INTERVENTIONS: Prescribed graded aerobic exercise (active treatment) and relaxation and flexibility (control treatment). MAIN OUTCOME MEASURES: Participants' self assessment of improvement, tender point count, impact of condition measured by fibromyalgia impact questionnaire, and short form McGill pain questionnaire. RESULTS: Compared with relaxation exercise led to significantly more participants rating themselves as much or very much better at three months: 24/69 (35%) v 12/67 (18%), P=0.03. Benefits were maintained or improved at one year follow up when fewer participants in the exercise group fulfilled the criteria for fibromyalgia (31/69 v 44/67, P=0.01). People in the exercise group also had greater reductions in tender point counts (4.2 v 2.0, P=0.02) and in scores on the fibromyalgia impact questionnaire (4.0 v 0.6, P=0.07). CONCLUSIONS: Prescribed graded aerobic exercise is a simple, cheap, effective, and potentially widely available treatment for fibromyalgia.

Adult↗

PubMed2003

Design, analysis and presentation of factorial randomised controlled trials.

BACKGROUND: The evaluation of more than one intervention in the same randomised controlled trial can be achieved using a parallel group design. However this requires increased sample size and can be inefficient, especially if there is also interest in considering combinations of the interventions. An alternative may be a factorial trial, where for two interventions participants are allocated to receive neither intervention, one or the other, or both. Factorial trials require special considerations, however, particularly at the design and analysis stages. DISCUSSION: Using a 2 x 2 factorial trial as an example, we present a number of issues that should be considered when planning a factorial trial. The main design issue is that of sample size. Factorial trials are most often powered to detect the main effects of interventions, since adequate power to detect plausible interactions requires greatly increased sample sizes. The main analytical issues relate to the investigation of main effects and the interaction between the interventions in appropriate regression models. Presentation of results should reflect the analytical strategy with an emphasis on the principal research questions. We also give an example of how baseline and follow-up data should be presented. Lastly, we discuss the implications of the design, analytical and presentational issues covered. SUMMARY: Difficulties in interpreting the results of factorial trials if an influential interaction is observed is the cost of the potential for efficient, simultaneous consideration of two or more interventions. Factorial trials can in principle be designed to have adequate power to detect realistic interactions, and in any case they are the only design that allows such effects to be investigated.

Data Interpretation, Statistical↗

PubMed2000

Randomised controlled trial of two pressure-relieving systems.

The primary objective of this randomised controlled trial was to determine whether there were significant differences between two pressure-relieving systems. A secondary aim was to investigate whether the availability of extra pressure-relieving equipment would reduce the incidence of ulcers in an acute hospital setting. A total of 141 patients in a care-of-the-elderly unit, who were assessed to have a high risk of developing pressure ulcers using the Waterlow score, were recruited; 70 were nursed using Huntleigh Nimbus 3 in conjunction with the Aura cushion (Group A), and 71 using the Pegasus Cairwave Therapy System in conjunction with the Proactive 2 Seating cushion (Group B). The main outcome measure was visual assessment, supported by a photographic record. There were three main findings: for non-heel ulcers and overall improvement, there was no statistically significant difference between the two products tested; for heel ulcers there was a significant difference (P = 0.019) with more patients healing in Group A than in Group B. The average length of stay of patients who completed the trial was 21.6 days (Group A) and 21.7 days (Group B) for patients completing a live (range 1-121 days) and for patients who died 29.7 days (Group A) and 24.3 days (Group B). Routine monitoring showed that, before the trial, the incidence of hospital-acquired pressure ulcers (Torrance grade 2+) was 0.2%; during the trial, this dropped to 0.13%. The study showed differences in the efficacy of different mattress products; with a sufficiently large study, it is possible to demonstrate statistically significant results. Provision of extra pressure-relieving equipment can reduce the incidence of pressure ulcers but may not influence length of stay.

Aged↗

PubMed2005

Breastfeeding expectations versus reality: a cluster randomised controlled trial.

OBJECTIVE: To evaluate the affect of an antenatal educational breastfeeding intervention on women's breastfeeding duration. DESIGN: Cluster randomised controlled trial. Unit of randomisation: electoral ward. The primary outcome was the proportion that fulfilled their antenatal breastfeeding expectation. Secondary outcomes were the number of women breastfeeding on discharge and at four months. Data were collected using a series of questionnaires and diaries. SETTING: Teaching hospital in North West of England. PARTICIPANTS: Women who expressed a desire to breast-feed at the start of their pregnancy. METHODS: Women were allocated to either routine antenatal education or an additional single educational group session supervised by a lactation specialist and attended by midwives from their locality. MAIN OUTCOME MEASURE: The proportion of women who fulfilled their expectation of breastfeeding. RESULT: One thousand three hundred and twelve women were randomised, with 1249 (95%) women available for analysis. There was no difference between the groups in the proportion of women who attained their expected duration of breastfeeding (OR 1.2; 95% CI 0.89-1.6; chi(2)= 1.4, df= 1, P= 0.2; mean cluster size 156, design effect 1.6). There were no differences between the groups in the uptake of breastfeeding on discharge (OR = 1.2; 95% CI 0.8-1.7; chi(2)= 1.1, df= 1, P= 0.3; mean cluster size 163, design effect = 2.0) or exclusively at four months (OR = 1.1; 95% CI 0.6-1.8; chi(2)= 0.07, df= 1, P= 0.8; mean cluster size 156, design effect 1.6). CONCLUSION: The provision of a single educational group session supervised by a lactation specialist, and attended by midwives and women, failed to promote the uptake of breastfeeding. Public health interventions, which encourage positive attitudes to breastfeeding within the family and wider community, should be developed and evaluated.

Adult↗

PubMed1996

Blinding and exclusions after allocation in randomised controlled trials: survey of published parallel group trials in obstetrics and gynaecology.

OBJECTIVE: To assess the methodological quality of approaches to blind ing and to handling of exclusions as reported in randomised trials from one medical specialty. DESIGN: Survey of published, parallel group randomised controlled trials. DATA SOURCES: A random sample of 110 reports in which allocation was described as randomised from 1990 and 1991 volumes of four journals of obstetrics and gynaecology. MAIN OUTCOME MEASURES: The adequacy of the descriptions of double blinding and exclusions after randomisation. RESULTS: Through 31 trials reported being double blind, about twice as many could have been. Of the 31 trials only eight (26%) provided information on the protection of the allocation schedule and only five (16%) provided some written assurance of successful implementation of double blinding. Of 38 trials in which the authors provided sufficient information for readers to infer that no exclusions after randomisation had occurred, six (16%) reported adequate allocation concealment and none stated that an intention to treat analysis had been performed. That compared with 14 (27%) and six (12%), respectively, for the 52 trials that reported exclusions. CONCLUSIONS: Investigators could have double blinded more often. When they did double blind, they reported poorly and rarely evaluated it. Paradoxically, trials that reported exclusions seemed generally of a higher methodological standard than those that had no apparent exclusions. Exclusions from analysis may have been made in some of the trials in which no exclusions were reported. Editors and readers of reports of randomised trials should understand that flawed reporting of exclusions may often provide a misleading impression of the quality of the trial.

Double-Blind Method↗

PubMed2006

Effect of patient completed agenda forms and doctors' education about the agenda on the outcome of consultations: randomised controlled trial.

OBJECTIVE: To assess the effect of patient completed agenda forms for the consultation and doctors' education on identifying patients' agendas on the outcome of consultations. DESIGN: Randomised controlled trial. SETTING: General practices in Leicestershire and Nottinghamshire, United Kingdom. PARTICIPANTS: 46 general practitioners and 976 patients. INTERVENTIONS: Education for general practitioners, with an embedded clustered randomised controlled trial of a patient agenda form. MAIN OUTCOME MEASURES: Number of problems identified, time required to manage each problem, duration of consultations, number of problems raised after the doctor considered the consultation finished ("by the way" questions), and patient satisfaction. RESULTS: Data were available from 45 doctors (98%) and 857 patients (88%). The number of problems identified in each consultation increased by 0.2 (95% confidence interval 0.1 to 0.4) with the agenda form, by 0.3 (0.1 to 0.6) with education, and by 0.5 (0.3 to 0.7) with both interventions. The time required to manage each problem was not affected. The duration of consultations with the agenda form was increased by 0.9 minutes (0.3 to 1.5 minutes) and with the combined intervention by 1.9 minutes (1.0 to 2.8 minutes). Patient satisfaction with the depth of the doctor-patient relationship was increased with the agenda form. The occurrence of "by the way" presentations did not change. CONCLUSION: A patient completed agenda form before the consultation or general practitioner education about the agenda form, or both, enabled the identification of more problems in consultations even though consultations were longer.

England↗

PubMed2006

Reporting of radiographic methods in randomised controlled trials assessing structural outcomes in rheumatoid arthritis.

BACKGROUND: Because an increasing number of clinical trials evaluating disease-modifying antirheumatic drugs in rheumatoid arthritis (RA) emphasise radiographic outcomes as a primary outcome, using a reproducible radiographic measure should be placed at a premium. AIM: To evaluate the reporting of radiographic methods in randomised trials assessing radiographic outcomes in RA. METHODS: Medline was searched for randomised controlled trials assessing radiographic outcomes published between January 1994 and December 2005 in general medical and specialty journals with a high impact factor. One reader extracted data (radiographic acquisition, assessment and reproducibility) using a standardised form. RESULTS: A total of 46 reports were included in the analysis. The mean (SD) methodological quality scores on the Jadad scale (range 0-5) and the Delphi list (0-9) were 2.9 (1.2) and 6.4 (1.3), respectively. Use of a standardised procedure for the acquisition of the radiographs was reported in 2 (4.3%) articles. 2 (4.3%) reports indicated that the quality of the radiographs was evaluated. In 65.2% of the reports, > or = 2 radiographic scores were used. Reporting of radiographic assessment was well detailed for number of readers (91.3%), information on readers (71.7%), blinding (91.4%) and how films were viewed (74.0%). The reproducibility of the reading was reported in 39.1% of the articles. CONCLUSION: The reporting of results of randomised controlled trials of radiographic outcomes in RA shows great variability in radiographic scores used. Reporting of radiographic methods could be improved upon, especially the acquisition procedure and the reproducibility of the reading.

Arthritis, Rheumatoid↗

PubMed2004

Naratriptan for the treatment of acute migraine: meta-analysis of randomised controlled trials.

OBJECTIVE: To evaluate the comparative efficacy and tolerability of naratriptan in the treatment of acute attacks of migraine. DESIGN: Meta-analysis of randomised controlled trials using a random effects model. SUBJECTS: A total of 4499 patients suffering from moderate or severe attacks of acute migraine reported in ten trials. MAIN OUTCOME MEASURES: Response rate ratios for headache relief, pain-free response and sustained relief (4-24 hours). Adverse events were estimated with the rate ratio (RR), risk difference and number needed to harm. RESULTS: Pooled RRs relative to placebo for pain-free response at 2 and 4 hours for naratriptan 2.5 mg were 2.52 (95% CI: 1.78-3.57) and 2.58 (1.99-3.35). Naratriptan 2.5 mg was more effective than naratriptan 1 mg; the corresponding RRs for pain-free response at 2 and 4 hours were 1.54 (95% CI: 1.28-1.86) and 1.35 (1.20-1.51). In contrast, naratriptan 2.5 mg was less effective in pain-free response than either rizatriptan 10 mg at 4 hours (RR: 0.68; 95% CI: 0.55-0.85) or sumatriptan 100 mg at 4 hours (RR: 0.79; 95% CI: 0.67-0.93). However, significantly fewer patients experienced adverse effects with naratriptan 2.5 mg than with rizatriptan 10 mg (RR: 0.73; 95% CI: 0.56-0.97) or sumatriptan 100 mg (RR: 0.68; 95% CI: 0.55-0.86). CONCLUSIONS: Naratriptan is an effective and well-tolerated treatment for acute attacks of migraine. Head-to-head comparisons suggest that naratriptan 2.5 mg is significantly more effective than the 1 mg dose. Rizatriptan 10 mg and sumatriptan 100 mg were superior to naratriptan in terms of headache relief, while zolmitriptan 2.5 mg seemed to have comparable efficacy. Randomised controlled trials have shown that at licensed doses (1 and 2.5 mg), naratriptan is associated with a lower incidence of adverse effects than rizatriptan, sumatriptan and zolmitriptan. The incidence rates of adverse effects were similar to placebo.

Dose-Response Relationship, Drug↗

PubMed1996

Developing a training programme in patient-centred consulting for evaluation in a randomised controlled trial; diabetes care from diagnosis in British primary care.

AIM: To develop a feasible/theoretically based training programme in patient-centred consulting, for evaluation in a randomised controlled trial of diabetes care from diagnosis. METHODS: The programme was developed with four primary care teams and their patients in an action research framework, with observation of diabetes review consultations before and after training, and evaluated by questionnaire after each training session, among 23 general practitioners and 32 practice nurses from 21 practices in the trial. RESULTS: The observation study identified opportunities and obstacles to introducing a patient-centred approach into daily practice, especially in relation to time management and skill needs. The modified training programme was rated highly by participating general practitioners and nurses. CONCLUSIONS: Developing training programmes with the help of participating primary care teams ensures relevance and feasibility. Patient-centred consulting demands a shift from habitual consulting patterns. Practitioners are implementing the approach in practice, and the impact on patients is now under evaluation in the randomised controlled trial.

Diabetes Mellitus, Type 2↗

PubMed2002

Health promotion for adolescents in primary care: randomised controlled trial.

OBJECTIVES: To evaluate the effectiveness of inviting teenagers to general practice consultations to discuss health behaviour concerns and appropriate follow up care. DESIGN: Randomised controlled trial, with participants randomised to a consultation (intervention) or usual care (control). Questionnaires completed at baseline, 3 months, and 12 months. SETTING: Eight general practices in Hertfordshire, England. PARTICIPANTS: 1516 teenagers aged 14-15 years. INTERVENTION: Consultations with practice nurses to discuss health concerns and develop plans for healthier lifestyles. MAIN OUTCOME MEASURES: Mental and physical health, "stage of change" for health related behaviour, and use of health services. RESULTS: At baseline 970 teenagers completed questionnaires; 23% smoked, 35% had been drunk in the previous three months, 64% considered they ate unhealthily, 39% took little exercise, and 36% had possible depression. 41% (304) of teenagers invited attended for a consultation; over one third (112) were offered follow up care. More intervention group teenagers reported positive movement in stage of change for diet and exercise and in at least one of four behaviours (diet, exercise, smoking, drinking alcohol) at 3 months (41% v 31%, P<0.01), but this did not persist at 12 months. There was marginally more positive change in actual behaviour by intervention teenagers at 3 months (16% v 12%, P=0.06). Recognition of possible depression resulted in improved mental health outcomes at 3 and 12 months. 97% of attenders said they would recommend the intervention to a friend. CONCLUSIONS: Change in behaviour was slight but encouraging, and the intervention was well received and relatively cheap.

Adolescent↗

PubMed2005

Family support for stroke: one year follow up of a randomised controlled trial.

BACKGROUND: There is evidence that family support can benefit carers of stroke patients, but not the patients themselves. OBJECTIVE: To extend the follow up of a single blind randomised controlled trial of family support for stroke patients and carers to one year to ascertain whether there were any late effects of the intervention. METHODS: The study was a randomised controlled trial. Patients admitted to hospital with acute stroke who had a close carer were assigned to receive family support or normal care. Families were visited at home by a researcher 12 months after the stroke, and a series of questionnaires was administered to patient and carer. RESULTS: The benefits to carers mostly persisted, though they were no longer statistically significant because some patients were lost to follow up. There was no evidence of any effects on patients. CONCLUSION: Family support is effective for carers, but different approaches need to be considered to alleviate the psychosocial problems of stroke patients.

Adaptation, Psychological↗

PubMed2003

Effectiveness of neuraminidase inhibitors in treatment and prevention of influenza A and B: systematic review and meta-analyses of randomised controlled trials.

OBJECTIVE: To review the clinical effectiveness of oseltamivir and zanamivir for the treatment and prevention of influenza A and B. DESIGN: Systematic review and meta-analyses of randomised controlled trials. DATA SOURCES: Published studies were retrieved from electronic bibliographic databases; supplementary data were obtained from the manufacturers. SELECTION OF STUDIES: Randomised controlled, double blind trials that were published in English, had data available before 31 December 2001, evaluated treatment or prevention of naturally occurring influenza with zanamivir or oseltamivir (if given using the formulation and dosage licensed for clinical use), and reported at least one end point of relevance. REVIEW METHODS: The main outcome measures were the median time to the alleviation of symptoms (for treatment trials) and number of flu episodes avoided (for prevention trials). Three population groups were defined: children aged 12 years and under; otherwise healthy individuals aged 12 to 65 years; and "high risk" individuals (those with certain chronic medical conditions or aged 65 years and older). RESULTS: Seventeen treatment trials and seven prevention trials identified met the inclusion criteria. All trials included compared one of the drugs against placebo or standard care. Treatment of children, otherwise healthy individuals, and high risk populations with zanamivir reduced the median duration of symptoms in days respectively by 1.0 (95% confidence interval 0.5 to 1.5), 0.8 (0.3 to 1.3), and 0.9 (-0.1 to 1.9) for the intention to treat population. The corresponding results, in days, for oseltamivir were 0.9 (0.3 to 1.5), 0.9 (0.3 to 1.4), and 0.4 (-0.7 to 1.4). The effect of giving zanamivir and oseltamivir prophylactically resulted in a relative reduction of 70-90% in the odds of developing flu, depending on the strategy adopted and the population studied. CONCLUSIONS: Evidence from randomised controlled trials consistently supports the view that both oseltamivir and zanamivir are clinically effective for treating and preventing flu. However, evidence is limited for the treatment of certain populations and for all prevention strategies.

Acetamides↗

PubMed1999

Barriers to participation in randomised controlled trials: a systematic review.

METHOD: A systematic review of three bibliographic databases from 1986 to 1996 identified 78 papers reporting barriers to recruitment of clinicians and patients to randomised controlled trials. RESULTS: Clinician barriers included: time constraints, lack of staff and training, worry about the impact on the doctor-patient relationship, concern for patients, loss of professional autonomy, difficulty with the consent procedure, lack of rewards and recognition, and an insufficiently interesting question. Patient barriers included: additional demands of the trial, patient preferences, worry caused by uncertainty, and concerns about information and consent. CONCLUSIONS: To overcome barriers to clinician recruitment, the trial should address an important research question and the protocol and data collection should be as straightforward as possible. The demands on clinicians and patients should be kept to a minimum. Dedicated research staff may be required to support clinical staff and patients. The recruitment aspects of a randomised controlled trial should be carefully planned and piloted. Further work is needed to quantify the extent of problems associated with clinician and patient participation, and proper evaluation is required of strategies to overcome barriers.

Data Collection↗

PubMed2002

Systematic review of randomised controlled trials of over the counter cough medicines for acute cough in adults.

OBJECTIVES: To determine whether over the counter cough medicines are effective for acute cough in adults. DESIGN: Systematic review of randomised controlled trials. DATA SOURCES: Search of the Cochrane Acute Respiratory Infections Group specialised register, Cochrane Controlled Trials Register, Medline, Embase, and the UK Department of Health National Research Register in all languages. INCLUDED STUDIES: All randomised controlled trials that compared oral over the counter cough preparations with placebo in adults with acute cough due to upper respiratory tract infection in ambulatory settings and that had cough symptoms as an outcome. RESULTS: 15 trials involving 2166 participants met all the inclusion criteria. Antihistamines seemed to be no better than placebo. There was conflicting evidence on the effectiveness of antitussives, expectorants, antihistamine-decongestant combinations, and other drug combinations compared with placebo. CONCLUSION: Over the counter cough medicines for acute cough cannot be recommended because there is no good evidence for their effectiveness. Even when trials had significant results, the effect sizes were small and of doubtful clinical relevance. Because of the small number of trials in each category, the results have to be interpreted cautiously.

Acute Disease↗

PubMed2006

The demise of the randomised controlled trial: bibliometric study of the German-language health care literature, 1948 to 2004.

BACKGROUND: In order to reduce systematic errors (such as language bias) and increase the precision of the summary treatment effect estimate, a comprehensive identification of randomised controlled trials (RCT), irrespective of publication language, is crucial in systematic reviews and meta-analyses. We identified trials in the German general health care literature. METHODS: Eight German language general health care journals were searched for randomised controlled trials and analysed with respect to the number of published RCTs each year and the size of trials. RESULTS: A total of 1618 trials were identified with a median total number of 43 patients per trial. Between 1970 and 2004 a small but constant rise in sample size from a median number of 30 to 60 patients per trial can be observed. The number of published trials was very low between 1948 and 1970, but increased between 1970 and 1986 to a maximum of 11.2 RCTs per journal and year. In the following time period a striking decline of the number of RCTs was observed. Between 1999 and 2001 only 0.8 RCTs per journal and year were published, in the next three years, the number of published trials increased to 1.7 RCTs per journal and year. CONCLUSION: German language general health care journals no longer have a role in the dissemination of trial results. The slight rise in the number of published RCTs in the last three years can be explained by a change of publication language from German to English of three of the analysed journals.

Bibliometrics↗

PubMed2006

Effectiveness of telephone counselling by a pharmacist in reducing mortality in patients receiving polypharmacy: randomised controlled trial.

OBJECTIVE: To investigate the effects of compliance and periodic telephone counselling by a pharmacist on mortality in patients receiving polypharmacy. DESIGN: Two year randomised controlled trial. SETTING: Hospital medical clinic. PARTICIPANTS: 502 of 1011 patients receiving five or more drugs for chronic disease found to be non-compliant at the screening visit were invited for randomisation to either the telephone counselling group (n = 219) or control group (n = 223) at enrollment 12-16 weeks later. MAIN OUTCOME MEASURES: Primary outcome was all cause mortality in randomised patients. Associations between compliance and mortality in the entire cohort of 1011 patients were also examined. Patients were defined as compliant with a drug if they took 80-120% of the prescribed daily dose. To calculate a compliance score for the whole treatment regimen, the number of drugs that the patient was fully compliant with was divided by the total number of prescribed drugs and expressed as a percentage. Only patients who complied with all recommended drugs were considered compliant (100% score). RESULTS: 60 of the 502 eligible patients defaulted and only 442 patients were randomised. After two years, 31 (52%) of the defaulters had died, 38 (17%) of the control group had died, and 25 (11%) of the intervention group had died. After adjustment for confounders, telephone counselling was associated with a 41% reduction in the risk of death (relative risk 0.59, 95% confidence interval 0.35 to 0.97; P = 0.039). The number needed to treat to prevent one death at two years was 16. Other predictors included old age, living alone, rate of admission to hospital, compliance score, number of drugs for chronic disease, and non-treatment with lipid lowering drugs at screening visit. In the cohort of 1011 patients, the adjusted relative risk for death was 1.61 (1.05 to 2.48; P = 0.029) and 2.87 (1.80 to 2.57; P < 0.001) in patients with compliance scores of 34-66% and 0-33%, respectively, compared with those who had a compliance score of 67% or more. CONCLUSION: In patients receiving polypharmacy, poor compliance was associated with increased mortality. Periodic telephone counselling by a pharmacist improved compliance and reduced mortality. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number Register: SRCTN48076318.

Adult↗