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Results for “Randomised Controlled Trial”

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At least 1,261 records · Page 70Linked to original sources

PubMed2006

A non-randomised controlled trial of the clinical and cost effectiveness of a Supervised Exercise Programme for claudication.

OBJECTIVES: The main aims of treatment in patients with intermittent claudication (IC) are to improve the clinical indicators of lower limb ischaemia and patients' quality of life (QoL). The aims of this study were assess the clinical and cost effectiveness of a supervised exercise programme (SEP) in patients with IC. DESIGN: Non-randomised, controlled trial. SETTING: University teaching hospital. PATIENTS AND METHODS: Two groups of patients with IC were studied. Seventy patients were sequentially recruited before and after the establishment of a Supervised Exercise Programme at our unit. Thirty-seven patients (median age 69 years, 26 men) received conservative medical therapy (CMT) and 33 patients (median age 67 years, 22 men) received CMT plus a 3 month SEP of graduated physical exercise for sixty minutes, three times each week. Patients were assessed prior to and at 6 months following treatment. At each assessment patient reported walking distances (PRWD), treadmill claudication and maximal distances (ICD and MWD), ankle brachial pressure indices (ABPI) pre & post exercise and patient reported QoL using the SF36 questionnaire were assessed. RESULTS: Prior to intervention the two groups were well matched. Following treatment, CMT patients demonstrated no significant change in PRWD or ICD but did record a small but significant improvement in MWD. CMT was also associated with a negative effect size in the SF36 index and in 7 of the 8 SF36 QoL domains, effect size >-0.5 for the domains of Physical Function and Emotional Role. SEP patients demonstrated significant improvement in PRWD, ICD and MWD. SEP was associated with a positive effect size in the SF36 index and in 2 SF36 QoL domains but a negative effect size in a further 2 domains. However, all QoL effect sizes following SEP were < +/-0.5. Intergroup differences in effect sizes were >0.5 for the SF36 domains of Physical Function, Physical Role, Emotion Role and SF36 index. SEP resulted in a 0.027 quality adjusted life year (QALY) gain over CMT in the first year post-treatment thus the cost/QALY gained of SEP is pound1780 at 1 year. CONCLUSIONS: Compared to CMT, SEP increases walking distances, improves QoL and is a highly cost-effective treatment for IC.

Aged↗

PubMed2003

Pulsed-dye laser treatment for inflammatory acne vulgaris: randomised controlled trial.

BACKGROUND: Low-fluence (low irradiation energy density) pulsed-dye lasers (PDLs) have been used for atrophic acne scarring, and anecdotal experience suggests that long-term improvements in inflammatory acne can be seen after one PDL treatment. Our aim was to compare the efficacy and tolerability of such PDL treatment with sham treatment in patients with facial inflammatory acne in a double-blind, randomised controlled trial. METHODS: We recruited 41 adults with mild-to-moderate facial inflammatory acne. We randomly assigned patients to PDL (n=31) or sham treatment (n=10). Treatment was given at baseline and patients were seen after 2, 4, 8, and 12 weeks. Assessors and participants were unaware of treatment allocations. Primary outcome measures were acne severity after 12 weeks and adverse events at any time. Secondary measures were change in lesion counts after 12 weeks and change in acne severity with time. Analysis was by intention-to-treat. FINDINGS: After 12 weeks, acne severity (measured by Leeds revised grading system) was reduced from 3.8 (SD 1.5) to 1.9 (1.5) in the PDL group and 3.6 (1.8) to 3.5 (1.9) in the sham group (p=0.007). Treatment was well tolerated. Total lesion counts fell by 53% (IQR 19 to 64) in PDL patients and 9% (-16 to 38) in controls (p=0.023), and inflammatory lesion counts reduced by 49% (30 to 75) in PDL patients and 10% (-8 to 49) in controls (p=0.024). The most rapid improvements were seen in the first 4 weeks after treatment. INTERPRETATION: PDL therapy improves inflammatory facial acne 12 weeks after one treatment with no serious adverse effects.

Acne Vulgaris↗

PubMed1998

Point of care testing: randomised controlled trial of clinical outcome.

OBJECTIVES: To describe the proportion of patients attending an accident and emergency department for whom blood analysis at the point of care brought about a change in management; to measure the extent to which point of care testing resulted in differences in clinical outcome for these patients when compared with patients whose samples were tested by the hospital laboratory. DESIGN: Open, single centre, randomised controlled trial. Blood samples were randomly allocated to point of care testing or testing by the hospital's central laboratory. SETTING: The accident and emergency department of the Bristol Royal Infirmary, a large teaching hospital which cares for an inner city population. SUBJECTS: Representative sample of patients who attended the department between April 1996 and April 1997 and who required blood tests. Data collection was structured in 8 hour blocks so that all hours of the day and all days of the week were equally represented. MAIN OUTCOME MEASURES: The proportion of patients for whom point of care testing brought about a change in treatment in which timing was considered to be critical to clinical outcome. Mortality, the length of stay in hospital, admission rate, the amount of time spent waiting for results of blood tests, the amount of time taken to decide on management plans, and the amount of time patients spent in the department were compared between patients whose samples were tested at the point of care and those whose samples were sent to the laboratory. RESULTS: Samples were obtained from 1728 patients. Changes in management in which timing was considered to be critical occurred in 59 out of 859 (6.9%, 95% confidence interval 5.3% to 8.8%) patients in the point of care arm of the trial. Decisions were made 74 minutes earlier (68 min to 80 min, P < 0.0001) when point of care testing was used for haematological tests as compared to central laboratory testing, 86 minutes earlier (80 min to 92 min, P < 0.0001) for biochemical tests, and 21 minutes earlier (-3 min to 44 min, P = 0.09) for analyses of arterial blood gases. There were no differences between the groups in the amount of time spent in the department, length of stay in hospital, admission rates, or mortality. CONCLUSION: Point of care testing reduced the time taken to make decisions on patient management that were dependent on the results of blood tests. It also brought about faster changes in treatment for which timing was considered to be critical in about 7% of patients. These changes did not affect clinical outcome or the amount of time patients spent in the department.

Adult↗

PubMed1997

Randomised controlled trial of an aggressive nutritional regimen in sick very low birthweight infants.

AIMS: To improve energy intake in sick very low birthweight (VLBW) infants; to decrease growth problems, lessen pulmonary morbidity, shorten hospital stay, and avoid possible feeding related morbidity. Morbidity in VLBW infants thought to be associated with parenteral and enteral feeding includes bronchopulmonary dysplasia, necrotising enterocolitis, septicaemia, cholestasis and osteopenia of prematurity. METHODS: A prospective randomised controlled trial (RCT) comparing two types of nutritional intervention was performed involving 125 sick VLBW infants in the setting of a regional neonatal intensive care unit. Babies were randomly allocated to either an aggressive nutritional regimen (group A) or a control group (group B). Babies in group B received a conservative nutritional regimen while group A received a package of more aggressive parenteral and enteral nutrition. Statistical analysis was done using Student's t test, the Mann-Whitney U test, the chi 2 test and logistic regression. RESULTS: There was an excess of sicker babies in group A, as measured by initial disease severity (P < 0.01), but mean total energy intakes were significantly higher (P < 0.001) in group A at days 3 to 42 while receiving total or partial parenteral nutrition. Survival and the incidences of bronchopulmonary dysplasia, septicaemia, cholestasis, osteopenia and necrotising enterocolitis were similar in both groups. Growth in early life and at discharge from hospital was significantly better in babies in group A. There were no decreases in pulmonary morbidity or hospital stay. CONCLUSION: Nutritional intake in sick VLBW infants can be improved without increasing the risk of adverse clinical or metabolic sequelae. Improved nutritional intake resulted in better growth, both in discharge, but did not decrease pulmonary morbidity or shorten hospital stay.

Bacterial Infections↗

PubMed2006

A randomised controlled trial of motivational interviewing for smoking cessation.

BACKGROUND: Motivational interviewing is a technique used to promote change in addictive behaviour, initially used to treat alcoholism. Despite this, its effectiveness has not been sufficiently demonstrated for giving up smoking. AIM: The aim of the study was to establish whether motivational interviewing, compared with anti-smoking advice, is more effective for giving up the habit. DESIGN OF STUDY: Randomised controlled trial. SETTING: Primary care in Albecete, Spain. METHOD: Random experimental study of 200 smokers assigned to two types of interventions: anti-smoking advice (n = 86) and motivational interviewing (n = 114). Subjects in both groups were offered bupropion when nicotine dependency was high (Fagerström score >7). The success rate was evaluated by intention to treat; point prevalence abstinence was measured 6 and 12 months post intervention by personal testimony, confirmed by means of CO-oximetry (value < 6ppm). RESULTS: The measure of effectiveness of the treatment for giving up smoking after both 6 and 12 months, showed that the motivational interviewing action was 5.2 times higher than anti-smoking advice (18.4 % compared to 3.4%; 95% confidence interval = 1.63 to 17.13). CONCLUSION: The results of our study show that motivational interviewing is more effective than brief advice for giving up smoking.

Adolescent↗

PubMed2003

Randomised controlled trial to evaluate a new double-layer air-cell overlay for elderly patients requiring head elevation.

A clinical investigation was conducted concerning the effects of a newly designed double-layer air-cell overlay in preventing the onset of pressure ulcers for patients with a Braden scale score of < or = 16, and who require a head-elevated position of 45 degrees or higher. A randomised controlled trial was undertaken involving 82 patients from a general hospital ward using one of the following three support surfaces: a double-layer air-cell overlay, a single-layer air-cell overlay or a standard hospital mattress. A significantly lower percentage of patients using the double-layer air-cell overlay developed pressure ulcers (3.4%) compared to 19.2% and 37.0% for those patients using the single-layer air-cell overlay and standard mattress respectively. Based on these findings, a double-layer air-cell overlay should be more effective in preventing the onset of pressure ulcers than either a single-layer air-cell overlay or a standard hospital mattress for subjects requiring head elevation.

Age Factors↗

PubMed2000

Randomised controlled trial of CRP rapid test as a guide to treatment of respiratory infections in general practice.

OBJECTIVE: To assess whether the frequency of antibiotic prescriptions to patients with respiratory infections is reduced when general practitioners (GPs) use a C-reactive protein (CRP) rapid test in support of their clinical assessment, and to study whether using the test will have any effect on the course of disease DESIGN: Randomised controlled trial. SETTING: 35 general practices, County of Funen, Denmark. PATIENTS: 812 patients with respiratory infection. MAIN OUTCOME MEASURES: Frequency of antibiotic prescriptions and morbidity 1 week after the consultation, as stated by the patients. RESULTS: In the CRP group the frequency of antibiotic prescriptions was 43% (179/414) compared with 46% (184/398) in the control group (odds ratio (OR) = 0.9, NS). After 1 week, increased or unchanged morbidity was stated more frequently in the CRP group (12%) than in the control group (8%) (OR = 1.6, p = 0.05). In the control group, the variable having the greatest influence on whether the GP prescribed antibiotics was the patients' general well-being (OR = 2.9, p < 0.0001), whereas in the CRP group the CRP value had the greatest influence (OR = 1.1 per unit increase (mg/l), p < 0.0001). CONCLUSION: Based on the present study, the use of the CRP rapid test in support of a possible antibiotic treatment for respiratory infections in general practice cannot be recommended.

Adolescent↗

PubMed1998

A randomised controlled trial of postal versus interviewer administration of a questionnaire measuring satisfaction with, and use of, services received in the year before death.

STUDY OBJECTIVES: To develop a short form of an interview schedule used successfully in previous national surveys of care for the dying, and to investigate the effect of administering it by post on response rate, response bias and on the nature of responses to questions. DESIGN: Randomised controlled trial. SETTING: An inner London health authority. PARTICIPANTS: Informants (person registering death) of random sample of cancer deaths between June 1995 and July 1996. MAIN RESULTS: The shortened questionnaire (VOICES) has 158 questions. Response rate did not differ significantly between postal and interview groups (interview; 56% (69 of 123), postal: 52% (161 of 308). Responders in the two groups did not differ in terms of their sociodemographic characteristics. Postal questionnaires had significantly more missing data, particularly on questions about service provision and satisfaction with services. Responses to questions differed between the groups on 11 of 158 questions. Interview group respondents were more likely to give top ranking responses to questions on service satisfaction and symptom control. CONCLUSIONS: Postal questionnaires are an acceptable alternative to interviews in retrospective post-bereavement surveys of care for the dying, at least in terms of response rate and response bias. However, the increased costs of interview surveys need to be balanced against the fact that postal questionnaires result in more missing data, and possibly less reliable answers to some questions. Caution is needed in combining results from the two data collection methods as interview respondents gave more positive answers to some questions.

Adult↗

PubMed2003

A randomised controlled trial investigating the effect of nutritional supplementation on visual function in normal, and age-related macular disease affected eyes: design and methodology [ISRCTN78467674].

BACKGROUND: Age-related macular disease is the leading cause of blind registration in the developed world. One aetiological hypothesis involves oxidation, and the intrinsic vulnerability of the retina to damage via this process. This has prompted interest in the role of antioxidants, particularly the carotenoids lutein and zeaxanthin, in the prevention and treatment of this eye disease. METHODS: The aim of this randomised controlled trial is to determine the effect of a nutritional supplement containing lutein, vitamins A, C and E, zinc, and copper on measures of visual function in people with and without age-related macular disease. Outcome measures are distance and near visual acuity, contrast sensitivity, colour vision, macular visual field, glare recovery, and fundus photography. Randomisation is achieved via a random number generator, and masking achieved by third party coding of the active and placebo containers. Data collection will take place at nine and 18 months, and statistical analysis will employ Student's t test. DISCUSSION: A paucity of treatment modalities for age-related macular disease has prompted research into the development of prevention strategies. A positive effect on normals may be indicative of a role of nutritional supplementation in preventing or delaying onset of the condition. An observed benefit in the age-related macular disease group may indicate a potential role of supplementation in prevention of progression, or even a degree reversal of the visual effects caused by this condition.

Clinical Trial↗

PubMed2026

Sustained cognitive and functional effects of pro-cognitive interventions for bipolar disorder: A systematic review of randomised controlled trials.

A substantial proportion of individuals with bipolar disorder (BD) experience considerable cognitive deficits. Existing systematic reviews have evaluated the efficacy of pro-cognitive interventions in BD, but have not established whether any cognitive benefits translate into functional improvements, with evidence for sustained functional effects remaining limited. A systematic search was conducted on MEDLINE, EMBASE, PsycINFO and Cochrane Library from inception until 21 May 2026. Eligible studies were randomised controlled trials (RCTs) in BD reporting cognitive or functional outcomes at three or more months following a pro-cognitive intervention, or examining the translation of cognitive benefits into improvements in functional outcomes at any timepoint. Seven unique RCTs plus three secondary analyses of these trials (n = 615) met the inclusion criteria. Approximately 13% (7/55) of RCTs identified in the search of pro-cognitive interventions in adult BD assessed cognitive or functional outcomes at least 3 months after treatment end. Of the seven unique RCTs, most evaluated cognitive remediation (CR; k = 4). The average follow-up length was 4 months (range: 3-6 months). Three of the four RCTs examining CR reported cognitive benefits at 3 to 6 months, whereas only one CR RCT found consistent functional effects at 3 months. Evidence on the translation of cognitive benefits to functional improvements is scarce and inconsistent. Most trials examining pro-cognitive interventions do not examine whether potential benefits are sustained or whether they translate into improvements in real-world functioning. CR appears to be a promising intervention for achieving durable cognitive gains in BD, although evidence for sustained effects of other interventions is limited.

Humans↗

PubMed2000

Randomised controlled trial of problem solving treatment, antidepressant medication, and combined treatment for major depression in primary care.

OBJECTIVES: To determine whether problem solving treatment combined with antidepressant medication is more effective than either treatment alone in the management of major depression in primary care. To assess the effectiveness of problem solving treatment when given by practice nurses compared with general practitioners when both have been trained in the technique. DESIGN: Randomised controlled trial with four treatment groups. SETTING: Primary care in Oxfordshire. PARTICIPANTS: Patients aged 18-65 years with major depression on the research diagnostic criteria-a score of 13 or more on the 17 item Hamilton rating scale for depression and a minimum duration of illness of four weeks. INTERVENTIONS: Problem solving treatment by research general practitioner or research practice nurse or antidepressant medication or a combination of problem solving treatment and antidepressant medication. MAIN OUTCOME MEASURES: Hamilton rating scale for depression, Beck depression inventory, clinical interview schedule (revised), and the modified social adjustment schedule assessed at 6, 12, and 52 weeks. RESULTS: Patients in all groups showed a clear improvement over 12 weeks. The combination of problem solving treatment and antidepressant medication was no more effective than either treatment alone. There was no difference in outcome irrespective of who delivered the problem solving treatment. CONCLUSIONS: Problem solving treatment is an effective treatment for depressive disorders in primary care. The treatment can be delivered by suitably trained practice nurses or general practitioners. The combination of this treatment with antidepressant medication is no more effective than either treatment alone.

Adolescent↗

PubMed2001

Serum folate levels after UVA exposure: a two-group parallel randomised controlled trial.

BACKGROUND: Photodegradation of certain vitamins such as riboflavins, carotinoids, tocopherol, and folate has been well-documented. Previous observations suggest that ultraviolet (UV) radiation may cause folate deficiency. This is of great importance since folate deficiency is also known to be linked with the development of neural tube defects. To investigate the influence of UVA radiation on serum folate levels in vivo, we conducted a two-group randomised controlled trial on healthy subjects. MATERIAL AND METHODS: Twenty-four healthy volunteers with skin type II were enrolled into the study. Eight volunteers of the study population were randomly assigned to the control group. UVA irradiation was administered with an air-conditioned sunbed. Blood samples were taken from all volunteers at baseline (T1), 30 min after the first UVA exposure (T2), and at the end of the study 24 h after the sixth UV exposure (T3). The volunteers had two UVA exposures weekly within three weeks (cumulative UVA dose: 96 J/cm2). Volunteers of the control group had no UVA exposures. Serum folate was analysed with an automated immunoassay system. RESULTS: At all times of blood collection the differences between serum folate levels were insignificant (P > 0.05), except of the non-exposed controls at T2 (P < 0.05). We did not observed significant differences of folate levels between UVA exposed and non-exposed volunteers (P > 0.05). CONCLUSIONS: Our data suggest that both single and serial UVA exposures do not significantly influence serum folate levels of healthy subjects. Therefore, neural tube defects claimed to occur after periconceptual UVA exposure are probably not due to UVA induced folate deficiency.

Adult↗

PubMed2003

Modifying dyspepsia management in primary care: a cluster randomised controlled trial of educational outreach compared with passive guideline dissemination.

BACKGROUND: Quality improvement initiatives in health services rely upon the effective introduction of clinical practice guidelines. However, even well constructed guidelines have little effect unless supported by dissemination and implementation strategies. AIM: To test the effectiveness of 'educational outreach' as a strategy for facilitating the uptake of dyspepsia management guidelines in primary care. DESIGN OF STUDY: A pragmatic, cluster-randomised controlled trial of guideline introduction, comparing educational outreach with postal guideline dissemination alone. SETTING: One-hundred and fourteen general practices (233 general practitioners) in the Salford and Trafford Health authority catchment area in the northwest of England. METHOD: All practices received guidelines by post in July 1997. The intervention group practices began to receive educational outreach three months later. This consisted of practice-based seminars with hospital specialists at which guideline recommendations were appraised, and implementation plans formulated. Seminars were followed up with 'reinforcement' visits after a further 12 weeks. Outcome measures were: (a) the appropriateness of referral for; and (b) findings at, open access upper gastrointestinal endoscopy; (c) costs of GP prescriptions for acid-suppressing drugs, and (d) the use of laboratory-based serological tests for Helicobacter pylori. Data were collected for seven months before and/or after the intervention and analysed by intention-to-treat. RESULTS: (a) The proportion of appropriate referrals was higher in the intervention group in the six-month post-intervention period (practice medians: control = 50.0%, intervention = 63.9%, P < 0.05); (b) the proportion of major findings at endoscopy did not alter significantly; (c) there was a greater rise in overall expenditure on acid-suppressing drugs in the intervention as compared with the control group (+8% versus +2%, P = 0.005); and (d) the median testing rate per practice for H pylori in the post-intervention period was significantly greater in the intervention group (four versus O, P < 0.001). CONCLUSION: This study suggests that educational outreach may be more effective than passive guideline dissemination in changing clinical behaviour. It also demonstrates that unpredictable and unanticipated outcomes may emerge.

Algorithms↗

PubMed2002

Aborted genital herpes simplex virus lesions: findings from a randomised controlled trial with valaciclovir.

OBJECTIVES: In prospective trials, episodic valaciclovir significantly increased the chance of preventing or aborting the development of painful vesicular genital herpes simplex virus (HSV) lesions compared with placebo. We explored the clinical outcome of aborted lesions and its association with early treatment in a study designed to compare 3 and 5 days' treatment with valaciclovir. METHODS: In a randomised controlled trial, valaciclovir 500 mg twice daily for 3 or 5 days was initiated at the first symptoms of a genital herpes outbreak. The primary end point was length of episode with pain, HSV shedding, and aborted lesions secondary end points. The effect of time from symptom recognition to treatment initiation on aborted lesions was assessed in a post hoc analysis. RESULTS: In 531 patients, no differences were observed between 3 and 5 days' treatment in episode duration (median 4.7 v 4.6 days), loss of pain/discomfort (2.8 v 3.0 days), or lesion healing (4.9 v 4.5 days). Vesicular lesions were aborted in 27% of patients treated for 3 days v 21% of patients receiving valaciclovir for 5 days. The odds of achieving an aborted episode were 1.93 (95% CI: 1.28 to 2.90) times higher for those initiating treatment with valaciclovir within 6 hours of first sign or symptom. CONCLUSIONS: There was no difference between 3 and 5 days' treatment in reducing episode duration or lesion abortion. Prompt treatment with valaciclovir can abort genital HSV reactivation episodes, preventing a vesicular outbreak. Maximum treatment benefit depends on prompt therapy after recognition of symptoms.

Acyclovir↗

PubMed1998

Correction of lower eyelid retraction in thyroid eye disease: a randomised controlled trial of retractor tenotomy with adjuvant antimetabolite versus scleral graft.

BACKGROUND/AIMS: Lower eyelid retraction in thyroid eye disease contributes to ocular discomfort and an unsightly appearance, especially if asymmetrical. The use of donor scleral grafts is effective in lengthening the lower eyelids but carries a risk of virus transmission. Other techniques, including those which do not use grafts, need to be compared with scleral grafts. Recurrent retraction is a recognised complication of thyroid eyelid surgery; therefore, the authors investigated the use of antimetabolites to reduce postoperative fibrosis. METHODS: In this prospective randomised controlled trial of 25 patients (35 eyelids), the use of donor sclera in 20 lower eyelids (13 patients) was compared with partial tenotomy of the anterior part of the lower eyelid retractors (ALER) with adjuvant peroperative antimetabolite in 15 lower eyelids (12 patients). A 5 minute peroperative application of either 5-fluorouracil (25 mg/ml) in nine lower eyelids (eight patients) or mitomycin C (0.2 mg/ml) in six lower eyelids (four patients) was used to focally inhibit fibroblasts. Follow up ranged from 3 to 18 months (mean 7.8). RESULTS: One month after surgery the results of both groups were similar. However, at 3 months after surgery the results of scleral grafting were better than tenotomy with antimetabolites: 3/12 patients (25%) treated with tenotomy and adjuvant antimetabolite required subsequent surgery using grafts for correction of recurrent retraction. There were no significant complications associated with the use of antimetabolites in the eyelid in the doses used in this study. CONCLUSIONS: This randomised prospective trial shows that donor scleral grafts were more effective in the long term than partial tenotomy with adjuvant antimetabolite in the correction of lower eyelid retraction associated with thyroid eye disease. The use of peroperative antimetabolites in the lower eyelid was safe.

Adult↗

PubMed2026

Closed-loop insulin delivery for glycaemic control in hospitalised and perioperative adults: A systematic review and meta-analysis of randomised controlled trials.

We evaluated whether closed-loop insulin delivery improves glycaemic control in hospitalised and perioperative adults. PubMed/MEDLINE, Embase, CENTRAL, and ClinicalTrials.gov were searched from inception to 29 June 2026 for randomised controlled trials comparing closed-loop or automated insulin delivery with usual care or conventional insulin therapy. Random-effects meta-analyses were conducted; risk of bias was assessed using RoB 2 and certainty of evidence using GRADE. Seven trials involving 375 analysed participants were included. Closed-loop insulin delivery increased time in target glucose range by 23.91 percentage points (95% CI 19.40 to 28.43; I2 = 0%) and reduced mean glucose by 1.79 mmol/L (95% CI 1.06 to 2.53 lower; I2 = 36.3%); certainty was moderate for both outcomes. Two trials involving 69 participants reported compatible participant-level data for clinically significant hyperglycaemia, and both estimates favoured closed-loop insulin delivery, although the evidence was exploratory and imprecise. No severe hypoglycaemic events occurred in either group, precluding reliable estimation of comparative safety. Closed-loop insulin delivery may improve glycaemic process measures, but larger pragmatic trials are needed to establish clinical benefits, safety, and implementation feasibility.

Humans↗

PubMed2003

Can psychological models bridge the gap between clinical guidelines and clinicians' behaviour? A randomised controlled trial of an intervention to influence dentists' intention to implement evidence-based practice.

OBJECTIVE: The lag between publication of evidence for clinical practice and implementation by clinicians may be decades. Research using psychological models demonstrates that changing intention is very important in changing behaviour. This study examined an intervention (rehearsing alternative actions) to change dentists' intention to implement evidence-based practice (EBP) for third molar (TM) management. DESIGN: Randomised controlled trial / postal. SETTING: Primary care. SUBJECTS AND METHODS: Dentists were randomly selected from the Scottish Dental Practice Board Register, then randomly allocated to intervention or control groups, and sent a questionnaire. The intervention group listed management alternatives to TM extraction prior to their TM extraction intention, and the control group did not. Based on psychological models for reducing a behaviour's frequency (EBP is weighted against TM extraction), prior listing of alternatives should decrease extraction intention. MAIN OUTCOME MEASURES: Intention to extract TMs. RESULTS: A total of 99 dentists - 70 Males, 29 Females; mean age = 41.42 years (SD = 8.62) participated in the study. The intervention significantly influenced intention to extract TMs, as desired. Despite similar background and knowledge of management alternatives, participants in the intervention group had significantly lower intention to extract: control group mean (SD) = 0.39 (1.99); intervention group mean (SD) = -0.78 (1.89); mean difference (SE) = 1.17 (0.42); 95% confidence interval for the difference = 0.34 to 1.99. CONCLUSION: Results suggest this intervention, which successfully influenced a proximal predictor of behaviour pertinent to dental EBP, may result in improved EBP in a service-level trial. Basing implementation interventions and trial methodology on psychological models may effectively bridge the gap between clinical guidelines and practice.

Adult↗

PubMed2005

Promoting child safety in primary care: a cluster randomised controlled trial to reduce baby walker use.

BACKGROUND: Baby walkers are commonly used items of nursery equipment, but cause more than 3000 injuries each year in the UK. There is currently little evidence regarding the effectiveness of interventions in primary care to reduce walker use. AIM: To evaluate the effectiveness of an educational package provided by midwives and health visitors to reduce baby walker possession and use. DESIGN OF STUDY: Cluster randomised controlled trial. SETTING: Sixty-four general practices in Nottingham and North Nottinghamshire, UK. METHOD: An educational package aimed at discouraging mothers-to-be from obtaining and using a walker was delivered by midwives and health visitors to 1174 mothers-to-be of at least 28 weeks gestation. The control arm received usual care. Primary outcome measures were the possession and use of a walker. Secondary outcome measures included the frequency and duration of walker use, knowledge and attitudes towards walkers, plans to use a walker with future children, recommending a walker to a friend, and use of stair gates and fire guards. RESULTS: Intervention arm participants were significantly less likely to own (odds ratio [OR] = 0.63, 95% confidence interval [CI] = 0.43 to 0.93) or to use a walker (OR = 0.26, 95% CI = 0.08 to 0.84). They were significantly less likely to plan to use a walker with their next child (OR = 0.52, 95% CI = 0.31 to 0.86) or to agree that walkers keep children safe (OR = 0.35, 95% CI = 0.16 to 0.78). There was some evidence that they were less likely to recommend a walker to a friend (OR = 0.51, 95% CI = 0.28 to 0.91) or to agree that they help children to walk more quickly (OR = 0.53, 95% CI = 0.29 to 0.95). CONCLUSION: An educational package delivered by midwives and health visitors was effective in reducing baby walker possession and use. Providers of primary healthcare services should include baby walker education in their injury prevention strategy and child health promotion programme.

Accident Prevention↗