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Results for “Randomised Controlled Trial”

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PubMedDate not supplied

A randomised controlled trial of proprioceptive and balance training after surgical reconstruction of the anterior cruciate ligament.

A randomised controlled trial (29 participants) was used to compare a 6-week proprioceptive and balance exercise program with a 6-week strengthening program in the early phases of rehabilitation after anterior cruciate ligament (ACL) reconstruction. Measurements of functional activity were taken by a blinded assessor before the intervention and at the end of the 6 weeks. Results demonstrated that there were no significant differences between groups on hop testing at 6 weeks. For several items in the Cincinnati knee rating system and the patient specific functional scale however, the strengthening group improved more than the proprioceptive and balance group (p < .05). The hypothesis that proprioceptive and balance training would improve functional activity more than strengthening exercises was not supported. There was either no difference between the two forms of exercise or strength training may be more beneficial than proprioceptive and balance training in the early phase of rehabilitation after ACL reconstructive surgery.

Adult↗

PubMed2000

A randomised controlled trial of dietary energy restriction in the management of obese women with gestational diabetes.

A randomised controlled trial was designed to determine the effect of moderate 30% maternal dietary energy restriction on the requirement for maternal insulin therapy and the incidence of macrosomia in gestational diabetes. Although the control group restricted their intake to a level similar to that of the intervention group (6,845 kiloJoules (kJ) versus 6,579 kJ), the resulting cohort could not identify any adverse effect of energy restriction in pregnancy. Energy restriction did not alter the frequency of insulin therapy (17.5% in the intervention group and 16.9% in the control group). Mean birthweight (3,461 g in the intervention group and 3,267 g in the control group) was not affected. There was a trend in the intervention group towards later gestational age at commencement of insulin therapy (33 weeks versus 31 weeks) and lower maximum daily insulin dose (23 units versus 60 units) which did not reach statistical significance. Energy restriction did not cause an increase in ketonemia.

3-Hydroxybutyric Acid↗

PubMed1984

Day hospital rehabilitation--effectiveness and cost in the elderly: a randomised controlled trial.

The effectiveness and cost of day hospital care in rehabilitation were studied in a randomised controlled trial in 120 elderly patients who were assessed at referral and six weeks and five months later in activities of daily living skills and mood. Day hospital patients were compared with a control group, who were managed as they would have been before the availability of day hospital care. Day hospital patients showed a significant improvement in performance of activities of daily living at six weeks but not at five months; however, they had a sustained improvement in mood. The cost of day hospital rehabilitation was one third greater than that of rehabilitation by alternative means. In its current form the geriatric day hospital is not a cheap alternative to other means of rehabilitation. Expensive components of the day hospital should be critically re-examined and renewed emphasis placed on sufficient inpatient beds, domiciliary services, and day care centres.

Activities of Daily Living↗

PubMed1978

A randomised controlled trial of the effect on middle-aged men of advice to stop smoking.

A randomised controlled trial of smoking cessation is reported in 1445 male smokers aged 40-59 at high risk of cardiorespiratory disease. The 714 men in the intervention group were recalled for a series of personal interviews with a doctor. After one year, 51% of the intervention group reported that they were not smoking any cigarettes, and most of the others reported a reduction. Compared with the "normal care" group, the men in the intervention group showed a decline in the prevalence of sputum production and dyspnoea; ventilatory function did not improve but its rate of decline was significantly slowed. There were no evident effects on blood pressure levels, nor on electrocardiographic findings over three years, nor on sickness absence over one year. Mortality follow-up has continued for an average of 7.9 years; 98 (13.7%) of the intervention group have died, compared with 94 (12.9%) of the "normal care" group. The 95% confidence limits on mortality range from 2.63% in favour of intervention to 4.37% in favour of normal care. The power of the trial has been reduced by smoking cessation in the "normal care" group. It is concluded that smoking cessation in these middle-aged men improved the symptoms and progress of chronic bronchitis; but the reversibility of the risk of cigarettes to the smoker's life may have been overestimated in observational studies.

Absenteeism↗

PubMed2005

Conceptual framework and systematic review of the effects of participants' and professionals' preferences in randomised controlled trials.

OBJECTIVES: To develop a conceptual framework of preferences for interventions in the context of randomised controlled trials (RCTs), as well as to examine the extent to which preferences affect recruitment to RCTs and modify the measured outcome in RCTs through a systematic review of RCTs that incorporated participants' and professionals' preferences. Also to make recommendations on the role of participants' and professionals' preferences in the evaluation of health technologies. DATA SOURCES: Electronic databases. REVIEW METHODS: The conceptual review was carried out on published papers in the psychology and economics literature concerning concepts of relevance to patient decision-making and preferences, and their measurement. For the systematic review, studies across all medical specialities meeting strict criteria were selected. Data were then extracted, synthesised and analysed. RESULTS: Key elements for a conceptual framework were found to be that preferences are evaluations of an intervention in terms of its desirability and these preferences relate to expectancies and perceived value of the process and outcome of interventions. RCTs differed in the information provided to patients, the complexity of techniques used to provide that information and the degree to which preference elicitation may simply produce pre-existing preferences or actively construct them. Most current RCTs used written information alone. Preference can be measured in many different ways and most RCTs did not provide quantitative measures of preferences, and those that did tended to use very simple measures. The second part of the study, the systematic review included 34 RCTs. The findings gave support to the hypothesis that preferences affect trial recruitment. However, there was less evidence that external validity was seriously compromised. There was some evidence that preferences influenced outcome in a proportion of trials. However, evidence for preference effects was weaker in large trials and after accounting for baseline differences. Preference effects were also inconsistent in direction. There was no evidence that preferences influenced attrition. Therefore, the available evidence does not support the operation of a consistent and important 'preference effect'. Interventions cannot be categorised consistently on degree of participation. Examining differential preference effects based on unreliable categories ran the risk of drawing incorrect conclusions, so this was not carried out. CONCLUSIONS: Although patients and physicians often have intervention preferences, our review gives less support to the hypothesis that preferences significantly compromise the internal and external validity of trials. This review adds to the growing evidence that when preferences based on informed expectations or strong ethical objections to an RCT exist, observational methods are a valuable alternative. All RCTs in which participants and/or professionals cannot be masked to treatment arms should attempt to estimate participants' preferences. In this way, the amount of evidence available to answer questions about the effect of treatment preferences within and outwith RCTs could be increased. Furthermore, RCTs should routinely attempt to report the proportion of eligible patients who refused to take part because of their preferences for treatment. The findings also indicate a number of approaches to the design, conduct and analysis of RCTs that take account of participants' and/or professionals' preferences. This is referred to as a methodological tool kit for undertaking RCTs that incorporate some consideration of patients' or professionals' preferences. Future research into the amount and source of information available to patients about interventions in RCTs could be considered, with special emphasis on the relationship between sources inside and outside the RCT context. Qualitative research undertaken as part of ongoing RCTs might be especially useful. The processes by which this information leads to preferences in order to develop or extend the proposed expectancy--value framework could also be examined. Other areas for consideration include: how information about interventions changes participants' preferences; a comparison of the feasibility and effectiveness of different informed consent procedures; how strength of preference varies for different interventions within the same RCT and how these differences can be taken account of in the analysis; the differential effects of patients' and professionals' preferences on evidence arising from RCTs; and whether the standardised measurement of preferences within all RCTs (and analysis of the effect on outcome) would allow the rapid development of a significant evidence base concerning patient preferences, albeit in relation to a single preference design.

Attitude of Health Personnel↗

PubMed2003

Effectiveness of counselling patients on physical activity in general practice: cluster randomised controlled trial.

OBJECTIVE: To assess the long term effectiveness of the "green prescription" programme, a clinician based initiative in general practice that provides counselling on physical activity. DESIGN: Cluster randomised controlled trial. Practices were randomised before systematic screening and recruitment of patients. SETTING: 42 rural and urban general practices in one region of New Zealand. SUBJECTS: All sedentary 40-79 year old patients visiting their general practitioner during the study's recruitment period. INTERVENTION: General practitioners were prompted by the patient to give oral and written advice on physical activity during usual consultations. Exercise specialists continued support by telephone and post. Control patients received usual care. MAIN OUTCOME MEASURES: Change in physical activity, quality of life (as measured by the "short form 36" (SF-36) questionnaire), cardiovascular risk (Framingham and D'Agostino equations), and blood pressure over a 12 month period. RESULTS: 74% (117/159) of general practitioners and 66% (878/1322) of screened eligible patients participated in the study. The follow up rate was 85% (750/878). Mean total energy expenditure increased by 9.4 kcal/kg/week (P=0.001) and leisure exercise by 2.7 kcal/kg/week (P=0.02) or 34 minutes/week more in the intervention group than in the control group (P=0.04). The proportion of the intervention group undertaking 2.5 hours/week of leisure exercise increased by 9.72% (P=0.003) more than in the control group (number needed to treat=10.3). SF-36 measures of self rated "general health," "role physical," "vitality," and "bodily pain" improved significantly more in the intervention group (P<0.05). A trend towards decreasing blood pressure became apparent but no significant difference in four year risk of coronary heart disease. CONCLUSION: Counselling patients in general practice on exercise is effective in increasing physical activity and improving quality of life over 12 months.

Adult↗

PubMed2001

Long term clinical outcome of a randomised controlled trial of anterior chamber lenses after high volume intracapsular cataract surgery.

BACKGROUND: Age related cataract remains the major cause of blindness throughout the world. In many countries, the majority of cataract surgery continues to be done by the intracapsular cataract extraction (ICCE) method. The results of a large randomised controlled trial of multiflex open loop anterior chamber intraocular lenses (ACIOL) were reported from a busy eye hospital in Nepal. METHODS: There was a randomised controlled trial of 2000 people with bilateral cataract reducing vision to less than 6/36. Interventions were ICCE with an ACIOL compared with ICCE with aphakic spectacles (+11 dioptres). Participants were followed at discharge, 6 weeks, 1 year, and 1 1/2-5 years after surgery. Visual acuity and clinical outcome were measured. A poor outcome was defined as vision <6/60. RESULTS: Visual outcome was comparable in the two groups. More of the control group experienced functional blindness due to loss of aphakic spectacles at 1 year. The majority of cases of poor outcome occurred in the first year after surgery. There was no indication of any lens related problems after 1 year. CONCLUSION: Multiflex open loop anterior chamber lenses are safe for up to 1 year of follow up when used by experienced surgeons, and the available evidence of 2-5 years of follow up suggests that the complication rate is reasonably low. An ACIOL at the time of cataract surgery offers benefits over routine ICCE surgery with aphakic spectacle correction as it avoids the problem of replacing lost and broken spectacles.

Adult↗

PubMed2001

Sample size and statistical power of randomised, controlled trials in orthopaedics.

We reviewed all 717 manuscripts published in the 1997 issues of the British and American volumes of the Journal of Bone and Joint Surgery and in Clinical Orthopaedics and Related Research, from which 33 randomised, controlled trials were identified. The results and sample sizes were used to calculate the statistical power of the study to distinguish small (0.2 of standard deviation), medium (0.5 of standard deviation), and large (0.8 of standard deviation) effect sizes. Of the 33 manuscripts analysed, only three studies (9%) described calculations of sample size. To perform post-hoc power assessments and estimations of deficiencies of sample size, the standard effect sizes of Cohen (small, medium and large) were calculated. Of the 25 studies which reported negative results, none had adequate power (beta < 0.2) to detect a small effect size and 12 (48%) lacked the power necessary to detect a large effect size. Of the 25 studies which did not have an adequate size of sample to detect small differences, the average used was only 10% of the required number Our findings suggest that randomised, controlled trials in clinical orthopaedic research utilise sample sizes which are too small to ensure statistical significance for what may be clinically important results.

Humans↗

PubMed2006

Randomised controlled trial of welfare rights advice accessed via primary health care: pilot study [ISRCTN61522618].

BACKGROUND: Little research has directly evaluated the impact of increasing financial or material resources on health. One way of assessing this lies with assisting people to obtain full welfare benefit entitlements. In 2000-1, 2.3 million pensioners were living in poverty in the UK and estimates suggest that around one million do not claim the financial support to which they are entitled. The effectiveness of welfare rights advice services delivered via primary health care to promote health and reduce health inequalities is unknown. METHODS: The main objectives of this study were to assess the feasibility and acceptability of a randomised controlled trial of welfare rights advice in a community setting and identify appropriate health and social outcome measures in order to plan a definitive trial. This was a single blind, community-based, pilot randomised controlled trial. 126 men and women aged 60 years and over, recruited from 4 general practices in Newcastle upon Tyne, UK, participated. The intervention comprised a structured welfare rights assessment followed by active assistance with welfare benefit claims over the following 24 months. The control group received the intervention after a six month delay. A range of socio-economic, health, behavioural and psycho-social outcomes were measured. RESULTS: 126 out of 400 people invited agreed to participate and 109 were followed up at 24 months. Both the intervention and research procedures were feasible and acceptable to participants and professionals involved. 68 (58%) of all participants received a welfare benefit award (31 financial, 16 non-financial and 21 both). Median time to receipt of benefits from initial assessment was 14 (range 1 to 78) weeks and median financial award was pounds 55 (Euro 81, dollar 98) per household per week. There was little evidence of health-related differences between groups or over time, which could be due to limitations of the study design. CONCLUSION: Modification of the study design, including selection of study participants, timing of interventions and length of follow up are recommended for a definitive trial. More appropriate health and psycho-social outcome measures relevant to the elderly population should be sought, particularly focussing on those issues highlighted in the accompanying qualitative study.

Aged↗

PubMed2004

Efficacy of topical non-steroidal anti-inflammatory drugs in the treatment of osteoarthritis: meta-analysis of randomised controlled trials.

OBJECTIVE: To assess the efficacy of topical non-steroidal anti-inflammatory drugs (NSAIDs) in the treatment of osteoarthritis. DATA SOURCES: Medline, Embase, Scientific Citation Index, CINAHL, Cochrane Library, and abstracts from conferences. REVIEW METHODS: Inclusion criterion was randomised controlled trials comparing topical NSAIDs with placebo or oral NSAIDs in osteoarthritis. Effect size was calculated for pain, function, and stiffness. Rate ratio was calculated for dichotomous data such as clinical response rate and adverse event rate. Number needed to treat to obtain the clinical response was estimated. Quality of trial was assessed, and sensitivity analyses were undertaken. RESULTS: Topical NSAIDs were superior to placebo in relieving pain due to osteoarthritis only in the first two weeks of treatment. Effect sizes for weeks 1 and 2 were 0.41 (95% confidence interval, 0.16 to 0.66) and 0.40 (0.15 to 0.65), respectively. No benefit was observed over placebo in weeks 3 and 4. A similar pattern was observed for function, stiffness, and clinical response rate ratio and number needed to treat. Topical NSAIDs were inferior to oral NSAIDs in the first week of treatment and associated with more local side effects such as rash, itch, or burning (rate ratio 5.29, 1.14 to 24.51). CONCLUSION: Randomised controlled trials of short duration only (less than four weeks) have assessed the efficacy of topical NSAIDs in osteoarthritis. After two weeks there was no evidence of efficacy superior to placebo. No trial data support the long term use of topical NSAIDs in osteoarthritis.

Administration, Topical↗

PubMed2005

Efficacy and tolerability of topical pimecrolimus and tacrolimus in the treatment of atopic dermatitis: meta-analysis of randomised controlled trials.

OBJECTIVE: To determine the efficacy and tolerability of topical pimecrolimus and tacrolimus compared with other treatments for atopic dermatitis. DESIGN: Systematic review and meta-analysis. DATA SOURCES: Electronic searches of the Cochrane Library, Medline, and Embase. STUDY SELECTION: Randomised controlled trials of topical pimecrolimus or tacrolimus reporting efficacy outcomes or tolerability. DATA EXTRACTION EFFICACY: investigators' global assessment of response; patients' global assessment of response; proportions of patients with flares of atopic dermatitis; and improvements in quality of life. Tolerability: overall rates of withdrawal; withdrawal due to adverse events; and proportions of patients with burning of the skin and skin infections. DATA SYNTHESIS: 4186 of 6897 participants in 25 randomised controlled trials received pimecrolimus or tacrolimus. Both drugs were significantly more effective than a vehicle control. Tacrolimus 0.1% was as effective as potent topical corticosteroids at three weeks and more effective than combined treatment with hydrocortisone butyrate 0.1% (potent used on trunk) plus hydrocortisone acetate 1% (weak used on face) at 12 weeks (number needed to treat (NNT) = 6). Tacrolimus 0.1% was also more effective than hydrocortisone acetate 1% (NNT = 4). In comparison, tacrolimus 0.03% was more effective than hydrocortisone acetate 1% (NNT = 5) but less effective than hydrocortisone butyrate 0.1% (NNT = -8). Direct comparisons of tacrolimus 0.03% and tacrolimus 0.1% consistently favoured the higher strength formulation, but efficacy differed significantly between the two strengths only after 12 weeks' treatment (rate ratio 0.80, 95% confidence interval 0.65 to 0.99). Pimecrolimus was far less effective than betamethasone valerate 0.1% (NNT = -3 at three weeks). Pimecrolimus and tacrolimus caused significantly more skin burning than topical corticosteroids. Rates of skin infections in any of the comparisons did not differ. CONCLUSIONS: Both topical pimecrolimus and topical tacrolimus are more effective than placebo treatments for atopic dermatitis, but in the absence of studies that show long term safety gains, any advantage over topical corticosteroids is unclear. Topical tacrolimus is similar to potent topical corticosteroids and may have a place for long term use in patients with resistant atopic dermatitis on sites where side effects from topical corticosteroids might develop quickly. In the absence of key comparisons with mild corticosteroids, the clinical need for topical pimecrolimus is unclear. The usefulness of either treatment in patients who have failed to respond adequately to topical corticosteroids is also unclear.

Administration, Topical↗

PubMed2004

Influence of guideline adherence on outcome in a randomised controlled trial on the efficacy of methotrexate with folate supplementation in rheumatoid arthritis.

OBJECTIVE: To study the influence of rheumatologists' adherence to a methotrexate guideline on efficacy and toxicity in the treatment of rheumatoid arthritis. METHODS: In a 48 week randomised controlled trial of methotrexate, comparing folates with placebo, rheumatologists were advised on methotrexate dosage using a guideline reflecting daily practice. The influence of guideline non-adherence on outcome was analysed using generalised estimating equations and survival analysis. RESULTS: In 51% of the 411 study patients the guidelines were always followed. Non-adherence resulted in lower doses of methotrexate in 25% of cases, and higher doses in 24%. The reduction in the disease activity score was significantly greater (mean -0.4; p = 0.0085) in the adherent group than in the "low dose" group; the "high dose" group did not differ from the adherent group. Dropout caused by severe adverse events did not differ between the three groups. CONCLUSIONS: There is an indication that adherence to guidelines on methotrexate dosage may benefit patients with rheumatoid arthritis by improving disease activity without increasing toxicity. For definite proof, a randomised controlled trial comparing guideline supported dosing with usual care is needed.

Adult↗

PubMed2006

Aspirin plus dipyridamole versus aspirin alone after cerebral ischaemia of arterial origin (ESPRIT): randomised controlled trial.

BACKGROUND: Results of trials of aspirin and dipyridamole combined versus aspirin alone for the secondary prevention of vascular events after ischaemic stroke of presumed arterial origin are inconsistent. Our aim was to resolve this uncertainty. METHODS: We did a randomised controlled trial in which we assigned patients to aspirin (30-325 mg daily) with (n=1363) or without (n=1376) dipyridamole (200 mg twice daily) within 6 months of a transient ischaemic attack or minor stroke of presumed arterial origin. Our primary outcome event was the composite of death from all vascular causes, non-fatal stroke, non-fatal myocardial infarction, or major bleeding complication, whichever happened first. Treatment was open, but auditing of outcome events was blinded. Primary analysis was by intention to treat. This study is registered as an International Standard Randomised Controlled Trial (number ISRCTN73824458) and with (NCT00161070). FINDINGS: Mean follow-up was 3.5 years (SD 2.0). Median aspirin dose was 75 mg in both treatment groups (range 30-325); extended-release dipyridamole was used by 83% (n=1131) of patients on the combination regimen. Primary outcome events arose in 173 (13%) patients on aspirin and dipyridamole and in 216 (16%) on aspirin alone (hazard ratio 0.80, 95% CI 0.66-0.98; absolute risk reduction 1.0% per year, 95% CI 0.1-1.8). Addition of the ESPRIT data to the meta-analysis of previous trials resulted in an overall risk ratio for the composite of vascular death, stroke, or myocardial infarction of 0.82 (95% CI 0.74-0.91). Patients on aspirin and dipyridamole discontinued trial medication more often than those on aspirin alone (470 vs 184), mainly because of headache. INTERPRETATION: The ESPRIT results, combined with the results of previous trials, provide sufficient evidence to prefer the combination regimen of aspirin plus dipyridamole over aspirin alone as antithrombotic therapy after cerebral ischaemia of arterial origin.

Aged↗

PubMed2004

Psychological treatment for bipolar disorders--a review of randomised controlled trials.

The increased acceptance of stress-vulnerability models of severe mental disorders and of brief evidence-based psychological treatments in their treatment has finally led to increased interest in the role of psychotherapies in bipolar disorders. This paper reviews the results from randomised controlled trials of psychological therapies as an adjunct to standard medications. The evidence suggests that the addition of a psychological therapy may significantly reduce symptoms, enhance social adjustment and functioning, and reduce relapses and hospitalisations in patients with bipolar disorder. However, the methodological problems in the published randomised controlled trials and the heterogeneity in the outcomes achieved (some therapies reduce manic but not depressive relapses, others have the opposite effect) suggests that further studies are required to fully establish the place of these approaches in day to day practice.

Bipolar Disorder↗

PubMed2005

Doctor-patient interaction in a randomised controlled trial of decision-support tools.

In this paper, we draw on the analytic perspectives of ethnomethodology to explore doctor-patient encounters in an experimental trial of a complex intervention: an efficacy randomised controlled trial (RCT) of decision-support tools in the UK. We show how the experimental context in which these encounters take place pervades the interactions within them. We argue that two interactional orders were at work in the encounters that we observed: (i) the ceremonial order of the consultation and (ii) the assemblage of the decision-support tool trial. We demonstrate how doctors in the trial oscillate between positions as authoritative clinician and neutralistic decision-support tool-implementer, and patients move between positions as passive recipients of clinical knowledge and as active subjects required to render their experience as calculable in terms of the demands of the decision-support tools and the broader trial they are embedded in. We demonstrate how the RCT coordinates the world of the clinical environment and the world of experimental evidence.

Decision Support Systems, Clinical↗

PubMed2005

Effectiveness and cost-effectiveness of a multidisciplinary intervention programme to prevent new falls and functional decline among elderly persons at risk: design of a replicated randomised controlled trial [ISRCTN64716113].

BACKGROUND: Falls are common among community-dwelling elderly people and can have a considerable impact on quality of life and healthcare costs. People who have sustained a fall are at greater risk of falling again.We replicated a British randomised controlled trial which demonstrated the effectiveness of a multidisciplinary intervention programme to prevent falls. The objective is to describe the design of a replication study evaluating a multidisciplinary intervention programme on recurrent falls and functional decline among elderly persons at risk. The study consists of an effect evaluation, an economic evaluation and a process evaluation. METHODS/DESIGN: The programme is aimed at community-dwelling elderly people aged 65 years or over who have visited an accident and emergency department (A&E department) or a general practitioners' cooperative (GP cooperative) because of a fall. The design involves a two-group randomised controlled trial. Participants are followed for twelve months after baseline. The intervention programme consists of a detailed medical and occupational therapy assessment with referral to relevant services if indicated. People in the control group receive usual care. The main outcome measures of the effect evaluation are number of falls and daily functioning. The economic evaluation will be performed from a societal perspective. A process evaluation will be carried out to evaluate the feasibility of the intervention programme.

Accidental Falls↗

PubMed2002

Self help smoking cessation in pregnancy: cluster randomised controlled trial.

OBJECTIVES: To evaluate the effectiveness of a self help approach to smoking cessation in pregnancy. DESIGN: Pragmatic cluster randomised controlled trial with community midwife as the unit of randomisation. SETTING: Three NHS hospital trusts in England. PARTICIPANTS: 1527 women who smoked at the start of pregnancy. INTERVENTION: A series of five self help booklets comprising a step by step programme to increase motivation for quitting smoking and to teach strategies for cessation and relapse prevention. The first booklet was given to the women by a midwife at the earliest opportunity in antenatal care, together with a booklet for partners, family members, and friends. The remaining four booklets were mailed directly to the women. MAIN OUTCOME MEASURES: The primary outcome was smoking cessation validated by cotinine measurement at the end of the second trimester of pregnancy. Other outcomes were self reported smoking status and cigarette consumption among daily smokers. Qualitative data exploring the acceptability of the intervention and the way that smoking cessation advice was delivered in both trial arms were also collected. RESULTS: Smoking cessation rates were low: the cotinine validated rates were 18.8% (113/600) in the intervention group and 20.7% (144/695) in the normal care group (difference 1.9%, 95% confidence intervals -3.5% to 7.3%). Self reported quit rates were higher. In the intervention group, 156 (25.6%) women reported not smoking for at least seven days, compared with 207 (29.1%) in the normal care group. In both groups, median self reported daily cigarette consumption among daily smokers was 10 cigarettes per day. Pregnant women and midwives approved of the intervention, but the way in which it was delivered varied considerably. For the primary smoking outcome, the degree of clustering at the midwife level was non-trivial (intracluster correlation coefficient 0.031). CONCLUSION: The self help intervention was acceptable but ineffective when implemented during routine antenatal care. More intensive and complex interventions, appropriately targeted and tailored, need to be developed and evaluated. Validated smoking cessation rates among pregnant women are substantially lower than the self reported rates on which current smoking policy is based.

Cluster Analysis↗

PubMedDate not supplied

Comparison of lumiracoxib with naproxen and ibuprofen in the Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET), reduction in ulcer complications: randomised controlled trial.

BACKGROUND: Cyclo-oxygenase 2 (COX2)-selective inhibitors should reduce ulcer complications compared with non-selective non-steroidal anti-inflammatory drugs, but evidence is limited, and the possibility that these inhibitors increase cardiovascular events has been raised. The Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET) aimed to assess gastrointestinal and cardiovascular safety of the COX2 inhibitor lumiracoxib compared with two non-steroidal anti-inflammatory drugs, naproxen and ibuprofen. METHODS: 18325 patients age 50 years or older with osteoarthritis were randomised to lumiracoxib 400 mg once daily (n=9156), naproxen 500 mg twice daily (4754), or ibuprofen 800 mg three times daily (4415) for 52 weeks, in two substudies of identical design (lumiracoxib vs ibuprofen or naproxen). Randomisation was stratified for low-dose aspirin use and age. The primary endpoint was the difference in time-to-event distribution of upper gastrointestinal ulcer complications (bleeding, perforation, or obstruction); analysis was by modified intention to treat. The principle measure of adverse cardiovascular events was the Antiplatelet Trialists' Collaboration endpoint (myocardial infarction, stroke, or cardiovascular death); this analysis was intention to treat. FINDINGS: 81 (0.44%) patients did not start treatment and 7120 (39%) did not complete the study. In patients not taking aspirin, the cumulative 1-year incidence of ulcer complications was 1.09% (95% CI 0.82-1.36) with non-steroidal anti-inflammatory drugs (64 events) versus 0.25% (95% CI 0.12-0.39) with lumiracoxib (14 events; hazard ratio 0.21 [95% CI 0.12-0.37], p<0.0001). Reductions in ulcer complications were also significant in the overall population (0.34 [0.22-0.52], p<0.0001) but not in those taking aspirin (0.79 [0.40-1.55], p=0.4876). In the overall population, 0.55% (50/9127) of those on non-steroidal anti-inflammatory drugs and 0.65% (59/9117) of those on lumiracoxib reached the cardiovascular endpoint (1.14 [0.78-1.66], p=0.5074). INTERPRETATION: Lumiracoxib showed a three to four-fold reduction in ulcer complications compared with non-steroidal anti-inflammatory drugs without an increase in the rate of serious cardiovascular events, suggesting that lumiracoxib is an appropriate treatment for patients with osteoarthritis.

Aged↗