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Results for “Randomised Controlled Trial”

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PubMed1999

Tamoxifen in treatment of intraductal breast cancer: National Surgical Adjuvant Breast and Bowel Project B-24 randomised controlled trial.

BACKGROUND: We have shown previously that lumpectomy with radiation therapy was more effective than lumpectomy alone for the treatment of ductal carcinoma in situ (DCIS). We did a double-blind randomised controlled trial to find out whether lumpectomy, radiation therapy, and tamoxifen was of more benefit than lumpectomy and radiation therapy alone for DCIS. METHODS: 1804 women with DCIS, including those whose resected sample margins were involved with tumour, were randomly assigned lumpectomy, radiation therapy (50 Gy), and placebo (n=902), or lumpectomy, radiation therapy, and tamoxifen (20 mg daily for 5 years, n=902). Median follow-up was 74 months (range 57-93). We compared annual event rates and cumulative probability of invasive or non-invasive ipsilateral and contralateral tumours over 5 years. FINDINGS: Women in the tamoxifen group had fewer breast-cancer events at 5 years than did those on placebo (8.2 vs 13.4%, p=0.0009). The cumulative incidence of all invasive breast-cancer events in the tamoxifen group was 4.1% at 5 years: 2.1% in the ipsilateral breast, 1.8% in the contralateral breast, and 0.2% at regional or distant sites. The risk of ipsilateral-breast cancer was lower in the tamoxifen group even when sample margins contained tumour and when DCIS was associated with comedonecrosis. INTERPRETATION: The combination of lumpectomy, radiation therapy, and tamoxifen was effective in the prevention of invasive cancer.

Antineoplastic Agents, Hormonal↗

PubMed1994

Ampicillin and metronidazole treatment in preterm labour: a multicentre, randomised controlled trial.

OBJECTIVE: To ascertain whether adjuvant ampicillin and metronidazole given to women in preterm labour with intact membranes would prolong pregnancy and decrease the perinatal mortality and morbidity. DESIGN: A multicentre, prospective, randomised controlled trial. SETTING: Three perinatal centres serving an indigent population. SUBJECTS: Eighty-one women in active preterm labour with otherwise uncomplicated singleton pregnancies between 26 and 34 weeks gestation or an ultrasound fetal weight estimate of 800 g to 1500 g. INTERVENTIONS: The study group received ampicillin and metronidazole for five days. The control group received no antibiotics. In all women contractions were suppressed with hexoprenaline and indomethacin for 24 h, and betamethasone was given for fetal lung maturity. MAIN OUTCOME MEASURES: Days gained and perinatal mortality and morbidity. RESULTS: The study (n = 43) and control groups (n = 38) were comparable at entry. In those receiving ampicillin and metronidazole the pregnancy was significantly prolonged (median 15 days versus 2.5 days, P = 0.04) with significantly more women still pregnant after seven days (63% versus 37%, P = 0.03, OR 0.34 95% CI 0.13-0.94). Significantly more infants in the control group developed necrotising enterocolitis than in the study group (5 versus 0, P = 0.02). CONCLUSION: Adjuvant ampicillin and metronidazole in the management of women in preterm labour with intact membranes significantly prolonged the pregnancy and decreased neonatal morbidity.

Adult↗

PubMed2004

Cycle helmet ownership and use; a cluster randomised controlled trial in primary school children in deprived areas.

AIMS: To assess the effectiveness of two different educational interventions plus free cycle helmets, in increasing cycle helmet ownership and use. METHODS: A cluster randomised controlled trial was carried out in 28 primary schools in deprived areas of Nottingham, involving 1213 year 5 schoolchildren (age 9 and 10). Children received either a helmet + educational pack (educational pack and order form for free cycle helmet) or a helmet + multifaceted intervention (educational pack, order form for free cycle helmet, school assembly, lesson devoted to cycle helmet education, and an invitation to a school based cycling event). RESULTS: The helmet + educational pack was as effective as the helmet + multifaceted intervention in terms of helmet ownership (OR 1.51, 95% CI 0.50 to 4.58) and wearing (OR 0.98, 95% CI 0.57 to 1.68). Helmet ownership significantly increased from baseline with both interventions, and wearing significantly increased from baseline with the helmet + educational pack. The interventions reduced the inequality in helmet ownership between children residing in deprived and non-deprived areas that had been present prior to the study. CONCLUSIONS: An educational pack plus a form to order a free cycle helmet is an effective way of increasing bicycle helmet ownership and use and reduces inequalities in helmet ownership among children in deprived areas. Further work is needed to determine the length of the effect of such interventions.

Accidents, Traffic↗

PubMed1998

Randomised controlled trial of effects of early discharge after surgery for breast cancer.

OBJECTIVE: To determine the effect of early discharge from hospital after surgery for breast cancer on physical and psychological illness. DESIGN: Randomised controlled trial comparing discharge two days after surgery (before removal of drain) with standard management (discharge after removal of drain). SETTING: Regional breast unit. SUBJECTS: 100 women with early breast cancer undergoing mastectomy and axillary node clearance (20) or breast conservation surgery (80). MAIN OUTCOME MEASURES: Physical illness (infection, seroma formation, shoulder movement) and psychological illness (checklist of concerns, Rotterdam symptom questionnaire, hospital anxiety and depression scale) preoperatively and at one month and three months postoperatively. RESULTS: Women discharged early had greater shoulder movement (odds ratio 0.28 (95% confidence interval 0.08 to 0.95); P = 0.042) and less wound pain (odds ratio 0.28 (0.10 to 0.79); P = 0.016) three months after surgery compared with women given standard management. One month after surgery scores were significantly lower on the Rotterdam symptom questionnaire in patients who were discharged early (ratio of geometric mean scores 0.73 (0.55 to 0.98) P = 0.035), but rates of psychological illness generally did not differ between groups. CONCLUSIONS: Increased rates of physical or psychological illness did not result from early discharge after surgery for breast cancer. This policy can be recommended for patients with support at home.

Adult↗

PubMed1999

Primary prevention of arterial thromboembolism in non-rheumatic atrial fibrillation in primary care: randomised controlled trial comparing two intensities of coumarin with aspirin.

OBJECTIVE: To investigate the effectiveness of aspirin and coumarin in preventing thromboembolism in patients with non-rheumatic atrial fibrillation in general practice. DESIGN: Randomised controlled trial. PARTICIPANTS: 729 patients aged >/=60 years with atrial fibrillation, recruited in general practice, who had no established indication for coumarin. Mean age was 75 years and mean follow up 2. 7 years. SETTING: Primary care in the Netherlands. INTERVENTIONS: Patients eligible for standard intensity coumarin (international normalised ratio 2.5-3.5) were randomly assigned to standard anticoagulation, very low intensity coumarin (international normalised ratio 1.1-1.6), or aspirin (150 mg/day) (stratum 1). Patients ineligible for standard anticoagulation were randomly assigned to low anticoagulation or aspirin (stratum 2). MAIN OUTCOME MEASURES: Stroke, systemic embolism, major haemorrhage, and vascular death. RESULTS: 108 primary events occurred (annual event rate 5.5%), including 13 major haemorrhages (0.7% a year). The hazard ratio was 0.91 (0.61 to 1.36) for low anticoagulation versus aspirin and 0.78 (0.34 to 1.81) for standard anticoagulation versus aspirin. Non-vascular death was less common in the low anticoagulation group than in the aspirin group (0.41, 0.20 to 0.82). There was no significant difference between the treatment groups in bleeding incidence. High systolic and low diastolic blood pressure and age were independent prognostic factors. CONCLUSION: In a general practice population (without established indications for coumarin) neither low nor standard intensity anticoagulation is better than aspirin in preventing primary outcome events. Aspirin may therefore be the first choice in patients with atrial fibrillation in general practice.

Aged↗

PubMed2001

Randomised controlled trial of an interactive multimedia decision aid on hormone replacement therapy in primary care.

OBJECTIVE: To determine whether a decision aid on hormone replacement therapy influences decision making and health outcomes. DESIGN: Randomised controlled trial. SETTING: 26 general practices in the United Kingdom. PARTICIPANTS: 205 women considering hormone replacement therapy. INTERVENTION: Patients' decision aid consisting of an interactive multimedia programme with booklet and printed summary. OUTCOME MEASURES: Patients' and general practitioners' perceptions of who made the decision, decisional conflict, treatment choice, menopausal symptoms, costs, anxiety, and general health status. RESULTS: Both patients and general practitioners found the decision aid acceptable. At three months, mean scores for decisional conflict were significantly lower in the intervention group than in the control group (2.5 v 2.8; mean difference -0.3, 95% confidence interval -0.5 to -0.2); this difference was maintained during follow up. A higher proportion of general practitioners perceived that treatment decisions had been made "mainly or only" by the patient in the intervention group than in the control group (55% v 31%; 24%, 8% to 40%). At three months a lower proportion of women in the intervention group than in the control group were undecided about treatment (14% v 26%; -12%, -23% to -0.4%), and a higher proportion had decided against hormone replacement therapy (46% v 32%; 14%, 1% to 28%); these differences were no longer apparent by nine months. No differences were found between the groups for anxiety, use of health service resources, general health status, or utility. The higher costs of the intervention were largely due to the video disc technology used. CONCLUSIONS: An interactive multimedia decision aid in the NHS would be popular with patients, reduce decisional conflict, and let patients play a more active part in decision making without increasing anxiety. The use of web based technology would reduce the cost of the intervention.

Decision Making, Computer-Assisted↗

PubMed2002

Prevalence of working smoke alarms in local authority inner city housing: randomised controlled trial.

OBJECTIVES: To identify which type of smoke alarm is most likely to remain working in local authority inner city housing, and to identify an alarm tolerated in households with smokers. DESIGN: Randomised controlled trial. SETTING: Two local authority housing estates in inner London. PARTICIPANTS: 2145 households. INTERVENTION: Installation of one of five types of smoke alarm (ionisation sensor with a zinc battery; ionisation sensor with a zinc battery and pause button; ionisation sensor with a lithium battery and pause button; optical sensor with a lithium battery; or optical sensor with a zinc battery). MAIN OUTCOME MEASURE: Percentage of homes with any working alarm and percentage in which the alarm installed for this study was working after 15 months. RESULTS: 54.4% (1166/2145) of all households and 45.9% (465/1012) of households occupied by smokers had a working smoke alarm. Ionisation sensor, lithium battery, and there being a smoker in the household were independently associated with whether an alarm was working (adjusted odds ratios 2.24 (95% confidence interval 1.75 to 2.87), 2.20 (1.77 to 2.75), and 0.62 (0.52 to 0.74)). The most common reasons for non-function were missing battery (19%), missing alarm (17%), and battery disconnected (4%). CONCLUSIONS: Nearly half of the alarms installed were not working when tested 15 months later. Type of alarm and power source are important determinants of whether a household had a working alarm.

Electric Power Supplies↗

PubMed2004

Randomised controlled trial of conservative management of postnatal urinary and faecal incontinence: six year follow up.

OBJECTIVE: To determine the long term effects of a conservative nurse-led intervention for postnatal urinary incontinence. DESIGN: Randomised controlled trial. SETTING: Community based intervention in three centres in the United Kingdom and New Zealand. PARTICIPANTS: 747 women with urinary incontinence at three months after childbirth, of whom 516 were followed up again at 6 years (69%). INTERVENTION: Active conservative treatment (pelvic floor muscle training and bladder training) at five, seven, and nine months after delivery or standard care. MAIN OUTCOME MEASURES: Urinary and faecal incontinence, performance of pelvic floor muscle training. RESULTS: Of 2632 women with urinary incontinence, 747 participated in the original trial. The significant improvements relative to controls in urinary (60% v 69%) and faecal (4% v 11%) incontinence at one year were not found at six year follow up (76% v 79% (95% confidence interval for difference in means -10.2% to 4.1%) for urinary incontinence, 12% v 13% (-6.4% to 5.1%) for faecal incontinence) irrespective of subsequent obstetric events. In the short term the intervention had motivated more women to perform pelvic floor muscle training (83% v 55%) but this fell to 50% in both groups in the long term. Both urinary and faecal incontinence increased in prevalence in both groups during the study period. CONCLUSIONS: The moderate short term benefits of a brief nurse-led conservative treatment of postnatal urinary incontinence may not persist, even among women with no further deliveries. About three quarters of women with urinary incontinence three months after childbirth still have this six years later.

Adult↗

PubMed2005

Effect of incorporating a 10 minute point of care test for salivary nicotine metabolites into a general practice based smoking cessation programme: randomised controlled trial.

OBJECTIVE: To investigate the effect of immediate feedback from a point of care test for salivary nicotine metabolites in promoting smoking cessation and reduction in tobacco use. DESIGN: Prospective, operator blinded, randomised controlled trial. SETTING: General dental practice, London. PARTICIPANTS: 100 adult smokers. INTERVENTIONS: Participants completed a questionnaire on smoking, undertook a clinical examination, and received counselling in smoking cessation. Saliva samples were analysed at presentation and at eight weeks for salivary nicotine metabolites using a 10 minute semiquantitative point of care test. MAIN OUTCOME MEASURES: Smoking cessation measured by salivary nicotine metabolite values (scale 0-6), patient feedback on the perceived value of the test (visual analogue scale) in quitting, and reduction in tobacco use. RESULTS: A higher smoking quit rate was achieved with the point of care test (23% cases v 7% controls; P < 0.039), and overall tobacco use also decreased (68% cases v 28% controls; P < 0.001). Baseline values for salivary nicotine metabolites did not differ between the groups (cases, mean 4.1, SD 1.3 and 4.3, 1.4; P = 0.51). 87 participants reattended at eight weeks (44 cases, 43 controls). Mean nicotine metabolite values at eight weeks were 2.58 (2.0) for cases and 4.29 (1.8) for controls (P < 0.001). CONCLUSION: Incorporation of individualised personal feedback using a point of care test for salivary nicotine metabolites into a general practice based smoking cessation programme increased quit rates by 17% at eight weeks and reduced tobacco use.

Biofeedback, Psychology↗

PubMed2006

Effect of needle size on immunogenicity and reactogenicity of vaccines in infants: randomised controlled trial.

OBJECTIVES: To assess the immunogenicity of vaccines for infants and to investigate whether the incidence of reactogenicity is reduced after each immunisation dose using needles of varying lengths and gauges. DESIGN: Randomised controlled trial. SETTING: 18 general practices within two UK primary care trusts. PARTICIPANTS: 696 healthy infants vaccinated at 2, 3, and 4 months of age, with follow-up to 5 months of age. INTERVENTIONS: Combined diphtheria, tetanus, whole cell pertussis, and Haemophilus influenzae type b vaccine and a serogroup C meningococcal glycoconjugate vaccine administered using either a wide, long needle (23 gauge/0.6 mm diameter, 25 mm), a narrow, short needle (25 gauge/0.5 mm diameter, 16 mm), or a narrow, long needle (25 gauge, 25 mm). MAIN OUTCOME MEASURES: Local and general reactions recorded by parents for three days after each dose; and diphtheria, tetanus, and H influenzae type b antibody concentrations and functional antibody against serogroup C Neisseria meningitidis 28-42 days after the third dose. RESULTS: Local reactions to diphtheria, tetanus, whole cell pertussis, H influenzae type b vaccinations decreased significantly with wide, long needles compared with narrow, short needles. At all three doses one less infant experienced local reactions at days 1, 2, or 3 for every six to eight vaccinated. Significantly fewer infants vaccinated with the long needle experienced severe local reactions. Non-inferiority of the immune response was shown using a wide, long needle rather than a narrow, short needle for serogroup C meningococcal glycoconjugate vaccine and for diphtheria but not for H influenzae type b or tetanus, although no evidence was found of a decrease. Little difference was found between needles of the same length but different gauges in local reaction or immune response. CONCLUSIONS: Long (25 mm) needles for infant immunisations can significantly reduce vaccine reactogenicity at each dose while achieving comparable immunogenicity to that of short (16 mm) needles. Trial registration Current Controlled Trials ISRCTN62032215 [controlled-trials.com].

Diphtheria-Tetanus-Pertussis Vaccine↗

PubMed2006

Use of a prophylactic antiemetic with morphine in acute pain: randomised controlled trial.

OBJECTIVE: The aim of this study was to compare the incidence of nausea and vomiting in patients with acute pain treated with morphine along with prophylactic metoclopramide or placebo. METHOD: A randomised controlled trial was carried out on patients requiring morphine for acute pain in the emergency department (ED) setting. Children under the age of 12, patients who had been vomiting or had already received prehospital analgesia, and those unable to give consent were excluded. All patients were given either metoclopramide (10 mg) or placebo (normal saline) followed by intravenous morphine. Pain scores (measured on a visual analogue scale) before and after morphine administration, all incidents of nausea or vomiting, the dose of morphine, and the patients' demographic data were recorded. Fisher's exact test was used for comparing the two groups of patients. RESULTS: A total of 259 patients were recruited. There were 123 patients in the metoclopramide group (age range 15-94 years; median age 53) and 136 patients in the placebo group (age range 17-93 years; median age 52.5). The overall incidence of nausea and vomiting in the whole study population was 2.7%, (1.6% in the metoclopramide group and 3.7% in the placebo group). The difference between the two groups was not statistically significant (Fisher's exact test = 0.451; p = 0.3; z-test statistic = 1.02; 95% CI -6% to 2%). CONCLUSION: When intravenous morphine is administered for acute pain, the overall incidence of nausea and vomiting is low, regardless of whether these patients are given prophylactic metoclopramide or not.

Acute Disease↗

PubMed1992

Randomised controlled trial of anti-smoking advice: final (20 year) results.

STUDY OBJECTIVE: The aim was to measure experimentally the effects in middle aged men of stopping smoking. DESIGN: The study was a randomised controlled trial. SETTING AND SUBJECTS: The subjects were 1445 male smokers, initially aged 40-59 years, who were selected from the Whitehall study survey of 16,016 civil servants on the basis of a high risk of cardiorespiratory disease. MAIN RESULTS: During the next 20 years there were 620 deaths (231 from coronary heart disease), 96 cases of lung cancer, and 159 other cancers. Comparing the intervention with the normal care group, total mortality was 7% lower, fatal coronary heart disease was 13% lower, and lung cancer (deaths+registrations) was 11% lower. An excess rate for other cancers, reported previously, did not persist into the second decade of the trial. CONCLUSIONS: The results are consistent with observational studies, implying that smoking cessation by middle aged men substantially improves their changes of avoiding lung cancer or a fatal heart attack. Our estimate from the trial is that out of every 100 men who stopped smoking, between six and 10 were in consequence alive 20 years later.

Adult↗

PubMed2000

Improving the Quality of Reports of Meta-Analyses of Randomised Controlled Trials: The QUOROM Statement.

BACKGROUND: The Quality of Reporting of Meta-analyses (QUOROM) conference was convened to address standards for improving the quality of reporting of meta-analyses of clinical randomised controlled trials (RCTs). METHODS: The QUOROM group consisted of 30 clinical epidemiologists, clinicians, statisticians, editors, and researchers. In conference, the group was asked to identify items they thought should be included in a checklist of standards. Whenever possible, checklist items were guided by research evidence suggesting that failure to adhere to the item proposed could lead to biased results. A modified Delphi technique was used in assessing candidate items. FINDINGS: The conference resulted in the QUOROM statement, a checklist, and a flow diagram. The checklist describes our preferred way to present the abstract, introduction, methods, results, and discussion sections of a report of a meta-analysis. It is organised into 21 headings and subheadings regarding searches, selection, validity assessment, data abstraction, study characteristics, and quantitative data synthesis, and in the results with < >, study characteristics, and quantitative data synthesis; research documentation was identified for eight of the 18 items. The flow diagram provides information about both the numbers of RCTs identified, included, and excluded and the reasons for exclusion of trials. INTERPRETATION: We hope this report will generate further thought about ways to improve the quality of reports of meta-analyses of RCTs and that interested readers, reviewers, researchers, and editors will use the QUOROM statement and generate ideas for its improvement. Copyright 2000 S. Karger GmbH, Freiburg

Journal Article↗

PubMed2005

Clinical and cost effectiveness of mechanical support for severe ankle sprains: design of a randomised controlled trial in the emergency department [ISRCTN 37807450].

BACKGROUND: The optimal management for severe sprains (Grades II and III) of the lateral ligament complex of the ankle is unclear. The aims of this randomised controlled trial are to estimate (1) the clinical effectiveness of three methods of providing mechanical support to the ankle (below knee cast, Aircast brace and Bledsoe boot) in comparison to Tubigrip, and (2) to compare the cost of each strategy, including subsequent health care costs. METHODS/DESIGN: Six hundred and fifty people with a diagnosis of severe sprain are being identified through emergency departments. The study has been designed to complement routine practice in the emergency setting. Outcomes are recovery of mobility (primary outcome) and usual activity, residual symptoms and need for further medical, rehabilitation or surgical treatment. Parallel economic and qualitative studies are being conducted to aid interpretation of the results and to evaluate the cost-effectiveness of the interventions. DISCUSSION: This paper highlights the design, methods and operational aspects of a clinical trial of acute injury management in the emergency department.

Ankle Injuries↗

PubMed2005

Epidural steroid injection for nerve root compression. A randomised, controlled trial.

We have assessed whether an epidural steroid injection is effective in the treatment of symptoms due to compression of a nerve root in the lumbar spine by carrying out a prospective, randomised, controlled trial in which patients received either an epidural steroid injection or an intramuscular injection of local anaesthetic and steroid. We assessed a total of 93 patients according to the Oxford pain chart and the Oswestry disability index and followed up for a minimum of two years. All the patients had been categorised as potential candidates for surgery. There was a significant reduction in pain early on in those having an epidural steroid injection but no difference in the long term between the two groups. The rate of subsequent operation in the groups was similar.

Adult↗

PubMed2004

A randomised controlled trial to measure the effect of chest pain unit care upon anxiety, depression, and health-related quality of life [ISRCTN85078221].

BACKGROUND: The chest pain unit (CPU) has been developed to provide a rapid and accurate diagnostic assessment for patients attending hospital with acute, undifferentiated chest pain. We aimed to measure the effect of CPU assessment upon psychological symptoms and health-related quality of life. METHODS: We undertook a single-centre, cluster-randomised controlled trial. Days (N = 442) were randomised in equal numbers to CPU or routine care. Patients with acute chest pain, undiagnosed by clinical assessment, ECG and chest radiograph, were recruited and followed up with self-completed questionnaires (SF-36 and HADS) at two days and one month after hospital attendance. RESULTS: Patients receiving CPU assessment had significantly higher scores on the physical functioning (difference 5.1 points; 95% CI 1.1 to 9.0), vitality (4.6; 1.3 to 8.0), and general health (5.7; 2.3 to 9.2) dimensions of the SF-36 at two days, and significantly higher scores on all except the emotional role dimension at one month. They also had significantly lower depression scores on the HADS depression scale at two days (0.93; 0.34 to 1.51) and one month (1.0; 0.36 to 1.66). However, initially lower anxiety scores at two days (0.89; 0.21 to 1.56) were not maintained at one month (0.48; -0.26 to 1.23). CPU assessment was associated with reduced prevalence (OR 0.71; 95% CI 0.52 to 0.97) and severity (6.5 mm on 100 m visual analogue scale; 95% CI 2.2 to 10.8) of chest pain at one month, but no significant difference in the proportion of patients taking time off work (OR 0.82; 95% CI 0.54 to 1.04). CONCLUSION: CPU assessment is associated with improvements in nearly all dimensions of quality of life and with reduced symptoms of depression.

Adult↗

PubMed2004

Randomised controlled trial of effect of leaflets to empower patients in consultations in primary care.

OBJECTIVE: To assess the impact of leaflets encouraging patients to raise concerns and to discuss symptoms or other health related issues in the consultation. DESIGN: Randomised controlled trial. SETTING: Five general practices in three settings in the United Kingdom. PARTICIPANTS: 636 consecutive patients, aged 16-80 years, randomised to receive a general leaflet, a depression leaflet, both, or neither. MAIN OUTCOMES: Mean item score on the medical interview satisfaction scale, consultation time, prescribing, referral, and investigation. RESULTS: The general leaflet increased patient satisfaction and was more effective with shorter consultations (leaflet 0.64, 95% confidence interval 0.19 to 1.08; time 0.31, 0.0 to 0.06; interaction between both -0.045, -0.08 to-0.009), with similar results for subscales related to the different aspects of communication. Thus for a 10 minute consultation the leaflet increased satisfaction by 7% (seven centile points) and for a five minute consultation by 14%. The leaflet overall caused a small non-significant increase in consultation time (0.36 minutes, -0.54 to 1.26). Although there was no change in prescribing or referral, a general leaflet increased the numbers of investigations (odds ratio 1.43, 1.00 to 2.05), which persisted when controlling for the major potential confounders of perceived medical need and patient preference (1.87, 1.10 to 3.19). Most of excess investigations were not thought strongly needed by the doctor or the patient. The depression leaflet had no significant effect on any outcome. CONCLUSIONS: Encouraging patients to raise issues and to discuss symptoms and other health related issues in the consultation improves their satisfaction and perceptions of communication, particularly in short consultations. Doctors do, however, need to elicit expectations to prevent needless investigations.

Adolescent↗

PubMedDate not supplied

A randomised controlled trial to determine the effectiveness of glass ionomer sealants in pre-school children.

BACKGROUND: Caries levels in pre-school children remain high in some areas of the UK. Studies of glass ionomer fissure sealants show their potential for caries prevention in permanent teeth, but their use in primary teeth has not been reported. AIM: To determine whether a glass ionomer fissure sealant placed on primary molars in pre-school children at high risk of developing dental caries can decrease the incidence of dental caries. MATERIAL: 508 children aged 18-30 months from high caries areas of South Wales with caries-free first primary molars were recruited to the trial after informed consent. METHODS: This was a placebo-controlled individual randomised controlled trial (RCT). All children (n = 508) received a standard package of dental health education. Children in the test group (n = 241) had their first primary molars sealed with glass ionomer. All the children were re-examined once at varying intervals between 12 and 30 months. RESULTS: Analysis of the caries data revealed no significant difference between test and control groups for any of the parameters examined. Examination of the confidence intervals showed no indication that there might be a difference even if the sample size had been increased. CONCLUSION: There is no evidence that the intervention as used in this population had any effect on caries incidence and it cannot be recommended as a clinical procedure.

Chi-Square Distribution↗