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Results for “Randomised Controlled Trial”

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PubMed2006

Prevention of anxiety and depression in the age group of 75 years and over: a randomised controlled trial testing the feasibility and effectiveness of a generic stepped care programme among elderly community residents at high risk of developing anxiety and depression versus usual care [ISRCTN26474556].

BACKGROUND: In frail elderly, the effects of depression and anxiety are deep encroaching. Indicated prevention studies, aimed at subjects with subthreshold disorder, have shown that well designed interventions are capable of reducing the incidence of depression and anxiety. In this randomised prevention trial for elderly, living in the community and suffering from subthreshold depression and anxiety, a stepped care programme was put together to be tested versus usual (GP) care. METHODS/DESIGN DESIGN: randomised controlled trial. (See figure 1: organisation chart) together with two other projects, this project is part of a national consortium that investigates the prevention of anxiety and depressive disorders in later life using a stepped care programme. The three projects have their own particular focus. This project is aimed at elderly living in the community.Inclusion: subjects with a high risk for depression and anxiety without clinical evidence of these syndromes. The participants are 75 years of age and over and have subthreshold symptoms of depression and or anxiety: they score above the cut-off point on the self-report Centre for Epidemiologic Studies Depression (CES-D) scale, but the criteria for a major depressive disorder or anxiety disorder (panic disorder, agoraphobia, social phobia, generalized anxiety disorder) according to a validated interview, the Mini International Neuropsychiatric Interview (MINI) are not fulfilled. OUTCOMES: primary outcome: incidence of a depressive or anxiety disorder over a period of two years (MINI); secondary outcome: a positive influence of the intervention, a stepped care programme, on symptoms of depression and anxiety and on quality of life as assessed with the CES D, the HADS A and the SF36 respectively (i.e. stabilisation or improvement of symptoms) [see table 1]. MEASUREMENTS: Take place at baseline and at 3, 6, 9, 12, 18 and 24 months. Trained independent evaluators assess depression and anxiety status, the primary end point (6, 12, 18, 24 months) [see table 2]. DISCUSSION: Late-life depression and anxiety are characterised by high prevalence, unfavourable prognosis, reduced quality of life, excess mortality and substantial societal costs. No health service, however well equipped, will be able to effectively treat all elderly with depression and anxiety. Therefore, development of (cost) effective means to prevent these disorders is very important.

Aged↗

PubMed2003

Prevention of coronary and stroke events with atorvastatin in hypertensive patients who have average or lower-than-average cholesterol concentrations, in the Anglo-Scandinavian Cardiac Outcomes Trial--Lipid Lowering Arm (ASCOT-LLA): a multicentre randomised controlled trial.

BACKGROUND: The lowering of cholesterol concentrations in individuals at high risk of cardiovascular disease improves outcome. No study, however, has assessed benefits of cholesterol lowering in the primary prevention of coronary heart disease (CHD) in hypertensive patients who are not conventionally deemed dyslipidaemic. METHODS: Of 19342 hypertensive patients (aged 40-79 years with at least three other cardiovascular risk factors) randomised to one of two antihypertensive regimens in the Anglo-Scandinavian Cardiac Outcomes Trial, 10305 with non-fasting total cholesterol concentrations 6.5 mmol/L or less were randomly assigned additional atorvastatin 10 mg or placebo. These patients formed the lipid-lowering arm of the study. We planned follow-up for an average of 5 years, the primary endpoint being non-fatal myocardial infarction and fatal CHD. Data were analysed by intention to treat. FINDINGS: Treatment was stopped after a median follow-up of 3.3 years. By that time, 100 primary events had occurred in the atorvastatin group compared with 154 events in the placebo group (hazard ratio 0.64 [95% CI 0.50-0.83], p=0.0005). This benefit emerged in the first year of follow-up. There was no significant heterogeneity among prespecified subgroups. Fatal and non-fatal stroke (89 atorvastatin vs 121 placebo, 0.73 [0.56-0.96], p=0.024), total cardiovascular events (389 vs 486, 0.79 [0.69-0.90], p=0.0005), and total coronary events (178 vs 247, 0.71 [0.59-0.86], p=0.0005) were also significantly lowered. There were 185 deaths in the atorvastatin group and 212 in the placebo group (0.87 [0.71-1.06], p=0.16). Atorvastatin lowered total serum cholesterol by about 1.3 mmol/L compared with placebo at 12 months, and by 1.1 mmol/L after 3 years of follow-up. INTERPRETATION: The reductions in major cardiovascular events with atorvastatin are large, given the short follow-up time. These findings may have implications for future lipid-lowering guidelines.

Adult↗

PubMed2003

A randomised controlled trial comparing two methods of teaching medical students trauma and orthopaedics: traditional lectures versus the "donut round".

OBJECTIVE: To assess whether a new form of teaching, the 'donut round', is as good at imparting factual knowledge as interactive lectures in both the short-term and the long-term. DESIGN: Randomised controlled trial. SETTING: University of Oxford Medical School. PARTICIPANTS: 106 fifth year clinical medical students taught half of their A&E/trauma course by donut round and half by lecture. MAIN OUTCOME MEASURES: The results of multiple choice questions (MCQs) divided according to how the material was taught. Three MCQ papers were set: one at the end of a four-week course, one approximately 10 weeks later and a final exam approximately 17 months after the first. RESULTS: At the first MCQ, the average result for questions taught by donut round was 41.0 (out of 50) and for those taught by conventional lecture was 40.1. At 10 weeks these averages fell to 36.3 and 37.3 and at 17 months they were 38.7 and 38.1, respectively. None of these pairs were significantly different. Ratios were calculated for each candidate by dividing their donut round score by their lecture score. The average ratios for the first, second and third MCQ papers were: 1.029, 1.007 and 1.027, respectively, and were not significantly different. The individual ratios of all candidates in all three MCQs were plotted against their equivalent total mark. The calculated linear regression showed a statistically significant advantage of donut rounds over lectures in those candidates who scored a total mark less than 89 (n=260, p=0.02). CONCLUSIONS: Donut rounds are at least as good as lectures in imparting factual knowledge and may provide a selective advantage to weaker students.

Clinical Competence↗

PubMed2004

Effectiveness of bupropion as an aid to stopping smoking before elective surgery: a randomised controlled trial.

Smoking is a risk factor for complications during and after surgery, but most smokers are unable to quit before elective surgery. We tested the efficacy of bupropion in improving smoking cessation rates in this setting by enrolling 47 patients from the elective surgery waiting list in a double-blind randomised controlled trial. Patients receiving bupropion had a lower daily cigarette consumption at the time of hospital admission, median (IQR) cigarettes per day: 6 (2-7) vs. 15 (9-20), p = 0.046. They also had a reduction in end-expired carbon monoxide (p = 0.004), a known contaminant of cigarette smoke, and increased arterial oxygen saturation on pulse oximetry (p = 0.011). They were more likely to have stopped smoking at the 3-week visit (p = 0.036), but not at the 6-week visit (p = 0.25) or at the time of hospital admission for surgery (p > 0.99). This study found that smokers waiting for elective surgery are more likely to reduce or stop smoking when treated with bupropion.

Adult↗

PubMed2001

Randomised controlled trial of the effect of ventilation tubes (grommets) on quality of life at age 1-2 years.

AIMS: To study the effect of treatment with ventilation tubes on quality of life in children aged 1-2 years with persistent otitis media with effusion (OME), as compared to watchful waiting. METHODS: Multicentre randomised controlled trial (n = 187) with two treatment arms: ventilation tubes and watchful waiting. Children were detected by auditory screening at the age of 9-12 months, and were subsequently diagnosed as having persistent (4-6 months) bilateral OME. Quality of life (TAIQOL and Erickson scales) was measured at 0, 6, and 12 months follow up. RESULTS: There was improvement in quality of life, but the ventilation tube group did not improve significantly more than the watchful waiting group. Although an attempt has been made to identify possible subgroups that benefit more, we were not able to find such subgroups, which might be a result of lack of power in this study. CONCLUSION: Ventilation tubes do not have a substantial incremental effect on the quality of life of infants aged 1-2 years with uncomplicated persistent bilateral OME.

Child, Preschool↗

PubMed2000

A randomised controlled trial and economic evaluation of a referrals facilitator between primary care and the voluntary sector.

OBJECTIVES: To compare outcome and resource utilisation among patients referred to the Amalthea Project, a liaison organisation that facilitates contact between voluntary organisations and patients in primary care, with patients receiving routine general practitioner care. DESIGN: Randomised controlled trial with follow up at one and four months. SETTING: 26 general practices in Avon. PARTICIPANTS: 161 patients identified by their general practitioner as having psychosocial problems. MAIN OUTCOME MEASURES: Primary outcomes were psychological wellbeing (assessed with the hospital anxiety and depression scale) and social support (assessed using the Duke-UNC functional social support questionnaire). Secondary outcomes were quality of life measures (the Dartmouth COOP/WONCA functional health assessment charts and the delighted-terrible faces scale), cost of contacts with the primary healthcare team and Amalthea Project, cost of prescribing in primary care, and cost of referrals to other agencies, over four months. RESULTS: The Amalthea group showed significantly greater improvements in anxiety (average difference between groups after adjustment for baseline -1.9, 95% confidence interval -3.0 to -0.7), other emotional feelings (average adjusted difference -0.5, -0.8 to -0.2), ability to carry out everyday activities (-0.5, -0.8 to -0.2), feelings about general health (-0.4, -0.7 to -0.1), and quality of life (-0.5, -0.9 to -0.1). No difference was detected in depression or perceived social support. The mean cost was significantly greater in the Amalthea arm than the general practitioner care arm ( pound153 v pound133, P=0. 025). CONCLUSION: Referral to the Amalthea Project and subsequent contact with the voluntary sector results in clinically important benefits compared with usual general practitioner care in managing psychosocial problems, but at a higher cost.

Adolescent↗

PubMed2000

Randomised controlled trial of midwife led debriefing to reduce maternal depression after operative childbirth.

OBJECTIVE: To assess the effectiveness of a midwife led debriefing session during the postpartum hospital stay in reducing the prevalence of maternal depression at six months postpartum among women giving birth by caesarean section, forceps, or vacuum extraction. DESIGN: Randomised controlled trial. SETTING: Large maternity teaching hospital in Melbourne, Australia. PARTICIPANTS: 1041 women who had given birth by caesarean section (n= 624) or with the use of forceps (n= 353) or vacuum extraction (n= 64). MAIN OUTCOME MEASURES: Maternal depression (score >/=13 on the Edinburgh postnatal depression scale) and overall health status (comparison of mean scores on SF-36 subscales) measured by postal questionnaire at six months postpartum. RESULTS: 917 (88%) of the women recruited responded to the outcome questionnaire. More women allocated to debriefing scored as depressed six months after birth than women allocated to usual postpartum care (81 (17%) v 65 (14%)), although this difference was not significant (odds ratio=1.24, 95% confidence interval 0.87 to 1.77). They were also more likely to report that depression had been a problem for them since the birth, but the difference was not significant (123 (28%) v 94 (22%); odds ratio=1. 37, 1.00 to 1.86). Women allocated to debriefing had poorer health status on seven of the eight SF-36 subscales, although the difference was significant only for role functioning (emotional): mean scores 73.32 v 78.98, t= -2.31, 95% confidence interval -10.48 to -0.84). CONCLUSIONS: Midwife led debriefing after operative birth is ineffective in reducing maternal morbidity at six months postpartum. The possibility that debriefing contributed to emotional health problems for some women cannot be excluded.

Adult↗

PubMed2003

Randomised controlled trial of the effect of evidence based information on women's willingness to participate in cervical cancer screening.

STUDY OBJECTIVE: To assess whether providing women with additional information on the pros and cons of screening, compared with information currently offered by the NHS, affects their intention to attend for screening. DESIGN: Randomised controlled trial. Participants were randomly assigned to receive either the control, (based on an NHS Cervical Screening Programme leaflet currently used), or the intervention leaflet (containing additional information on risks and uncertainties). SETTING: Three general practices in Birmingham. PARTICIPANTS: 300 women aged 20 to 64 attending the practices during a one month period. MAIN OUTCOME MEASURES: Intention to attend for screening. MAIN RESULTS: 283 women (94.3%) completed the study. Fewer women in the intervention (79%) than the control group (88%) expressed intention to have screening after reading the information leaflet (difference between groups 9.2%, 95% confidence intervals (CI) 3.2% to 21.7%). The crude odds ratio (OR) and 95% CI was 0.50 (0.26 to 0.97). After adjusting for other factors, the trend persisted (OR 0.60, 95% CI 0.28 to 1.29). Having a previous Pap smear was the only significant predictor of intention to have screening (adjusted OR 2.54, 95% CI 1.03 to 6.21). Subgroup analysis showed no intervention effect in intended uptake between women at higher and lower risk of cervical cancer (p=0.59). CONCLUSIONS: Providing women with evidence based information on the risks, uncertainties, and the benefits of screening, is likely to deter some, but not differentially those at higher risk.

Adult↗

PubMed2005

Patients' expectations about the benefit of antibiotic treatment: lessons from a randomised controlled trial.

BACKGROUND: Patient expectations may be an important component of a placebo effect, and yet few studies assess how patients' pre-existing expectations affect subsequent health outcomes. OBJECTIVES: To estimate the association between patients' expectations and time to cure in patients with clinically diagnosed acute bacterial rhinosinusitis. METHODS: In a randomised controlled trial, expectations about the benefit of an antibiotic therapy were measured prior to treatment with either an antibiotic or placebo. RESULTS: Of the patients asked for consent, 64% refused mostly because they either wanted or did not want to receive antibiotics. Over 25% of the patients who gave consent were ambivalent about the benefit of antibiotic therapy. Predictably there was no evidence of an association between expectations and time to cure in those that gave consent. CONCLUSIONS: Selection bias occurs if patients with strong expectations refuse to participate in a trial and if the success of the intervention depends in part on a patient's expectations. Methods that adjust for selection bias are recommended for trials where placebo effects are either of interest or could be an important component of an intervention.

Anti-Bacterial Agents↗

PubMed2006

Increased awareness of intimate partner abuse after training: a randomised controlled trial.

BACKGROUND: Intimate partner abuse is very common among female patients in family practice. In general, doctors overlook the possibility of partner abuse. AIM: To investigate whether awareness of intimate partner abuse, as well as active questioning, increase after attending focus group and training, or focus group only. DESIGN OF STUDY: Randomised controlled trial in a stratified sample. SETTING: Family practices in Rotterdam and surrounding areas. METHOD: A full-training group (n = 23), a group attending focus group discussions alone (n = 14), and a control group (n = 17) were formed. Data were collected with incident reporting of every female patient (aged >18 years) that was suspected of, or presented, partner abuse during a period of 6 months. The primary outcome measure was the number of reported patients; the secondary outcome measure was the number of patients with whom the GP had non-obvious reasons to suspect/discuss abuse. RESULTS: Comparison of the full-training group (n = 87 patients) versus the control group (n = 14 patients) resulted in a rate ratio of 4.54 (95% confidence interval [CI] = 2.55 to 8.09, P <0.001); the focus group only group (n = 30 cases) versus control group: rate ratio of 2.2 (95% CI = 1.14 to 4.26, P = 0.019); full-training versus the focus group only group: rate ratio of 2.19 (95% CI = 1.36 to 3.52, P = 0.001). Comparison of the fulltraining group with the untrained groups for awareness of partner abuse in case of non-obvious signs resulted in: odds ratio 5.92 (95% CI = 2.25 to 15.62, P <0.01) all corrected for sex, district, practice setting, working part/full-time, experience, and age of the doctor. CONCLUSIONS: Training was the most significant determinant to improve awareness and identification of intimate partner abuse. Active questioning increased, especially where there were non-obvious signs. The focus group on its own doubled the awareness of partner abuse.

Adult↗

PubMed2006

Limited impact on endoscopy demand from a primary care based 'test and treat' dyspepsia management strategy: the results of a randomised controlled trial.

BACKGROUND: Helicobacter pylori testing has been suggested as an alternative to endoscopy for young patients with dyspepsia. Secondary care studies have suggested that demand for endoscopy among this group could be reduced by up to 74%. However, the effect of H. pylori testing in the primary care setting, where the majority of dyspepsia is managed, is unclear. AIM: To determine the effects of providing a H. pylori serology service for GPs upon demand for open access endoscopy. DESIGN OF STUDY: A prospective randomised controlled trial. SETTING: Forty-seven general practices in Gloucestershire. METHOD: General practices were stratified by endoscopy referral rate and randomised into two groups. The intervention group was provided with access to H. pylori serology testing and encouraged to use it in place of endoscopy for patients aged under 55 years with dyspepsia. Endpoints were referral for endoscopy and serology use. RESULTS: There was a significant reduction in referrals for endoscopy in the intervention group compared to the control group: 18.8% (95% confidence interval = 5.0 to 30.6%; P = 0.009). CONCLUSIONS: Providing GPs with H. pylori serology testing reduced demand for open access endoscopy, but by less than previous studies had predicted.

Adult↗

PubMedDate not supplied

Effectiveness of home visitation by public-health nurses in prevention of the recurrence of child physical abuse and neglect: a randomised controlled trial.

BACKGROUND: Recurrence of child maltreatment is a major problem, yet little is known about approaches to reduce this risk in families referred to child protection agencies. Since home visitation by nurses for disadvantaged first-time mothers has proven effective in prevention of child abuse and neglect, we aimed to investigate whether this approach might reduce recidivism. METHODS: We enrolled in a randomised controlled trial 163 families with a history of one index child being exposed to physical abuse or neglect to compare standard treatment with a programme of home visitation by nurses in addition to standard treatment. The main outcome was recurrence of child physical abuse and neglect based on a standardised review of child protection records. Analysis was by intention to treat. FINDINGS: At 3-years' follow-up, records were available for 160 of 163 (98%) families randomised. 139 (85%) completed follow-up. Recurrence of child physical abuse (31 [43%] in the control group vs 29 [33%] in the intervention group) and neglect (37 [51%] vs 41 [47%]) did not differ between groups. However, hospital records showed significantly higher recurrence of either physical abuse or neglect in the intervention group than in the control group (21 [24%] vs 8 [11%]). There were no differences between groups for the other secondary outcome measures. INTERPRETATION: Despite the positive results of home visitation by nurses as an early prevention strategy, this visit-based strategy does not seem to be effective in prevention of recidivism of physical abuse and neglect in families associated with the child protection system. Much more effort needs to be directed towards prevention before a pattern of abuse or neglect is established in a family.

Adolescent↗

PubMed2004

Prevention of coronary and stroke events with atorvastatin in hypertensive patients who have average or lower-than-average cholesterol concentrations, in the Anglo-Scandinavian Cardiac Outcomes Trial--Lipid Lowering Arm (ASCOT-LLA): a multicentre randomised controlled trial.

BACKGROUND: The lowering of cholesterol concentrations in individuals at high risk of cardiovascular disease improves outcome. No study, however, has assessed benefits of cholesterol lowering in the primary prevention of coronary heart disease (CHD) in hypertensive patients who are not conventionally deemed dyslipidaemic. METHODS: Of 19 342 hypertensive patients (aged 40-79 years with at least three other cardiovascular risk factors) randomised to one of two antihypertensive regimens in the Anglo-Scandinavian Cardiac Outcomes Trial, 10,305 with nonfasting total cholesterol concentrations 6.5 mmol/L or less were randomly assigned additional atorvastatin 10 mg or placebo. These patients formed the lipid-lowering arm of the study. We planned follow-up for an average of 5 years, the primary endpoint being non-fatal myocardial infarction and fatal CHD. Data were analysed by intention to treat. FINDINGS: Treatment was stopped after a median follow-up of 3.3 years. By that time, 100 primary events had occurred in the atorvastatin group compared with 154 events in the placebo group (hazard ratio 0.64 [95% CI 0.50-0.83], p = 0.0005). This benefit emerged in the first year of follow-up. There was no significant heterogeneity among prespecified subgroups. Fatal and non-fatal stroke (89 atorvastatin vs 121 placebo, 0.73 [0.56-0.96], p = 0.024), total cardiovascular events (389 vs 486, 0.79 [0.69-0.90], p = 0.0005), and total coronary events (178 vs 247, 0.71 [0.59-0.86], p = 0.0005) were also significantly lowered. There were 185 deaths in the atorvastatin group and 212 in the placebo group (0.87 [0.71-1.06], p = 0.16). Atorvastatin lowered total serum cholesterol by about 1.3 mmol/L compared with placebo at 12 months, and by 1.1 mmol/L after 3 years of follow-up. INTERPRETATION: The reductions in major cardiovascular events with atorvastatin are large, given the short follow-up time. These findings may have implications for future lipid-lowering guidelines.

Adult↗

PubMed1996

Randomised controlled trial of single BCG, repeated BCG, or combined BCG and killed Mycobacterium leprae vaccine for prevention of leprosy and tuberculosis in Malawi. Karonga Prevention Trial Group.

BACKGROUND: Repeat BCG vaccination is standard practice in many countries for prevention of tuberculosis and leprosy, but its effectiveness has not been evaluated. The addition of Mycobacterium leprae antigens to BCG might improve its effectiveness against leprosy. A double-blind, randomised, controlled trial to evaluate both these procedures was carried out in Karonga District, northern Malawi, where a single BCG vaccine administered by routine health services had previously been found to afford greater than 50% protection against leprosy, but no protection against tuberculosis. METHODS: Between 1986 and 1989, individuals lacking a BCG scar were randomly assigned BCG alone (27,904) or BCG plus killed M leprae (38,251). Individuals with a BCG scar were randomly allocated placebo (23,307), a second BCG (23,456), or BCG plus killed M leprae (8102). Incident cases of leprosy and tuberculosis were ascertained over the subsequent 5-9 years. FINDINGS: 139 cases of leprosy were identified by May, 1995; 93 of these were diagnostically certain, definitely postvaccination cases. Among scar-positive individuals, a second BCG vaccination gave further protection against leprosy (about 50%) over a first BCG vaccination. The rate ratio for all diagnostically certain, definitely postvaccination cases, all ages, was 0.51 (95% CI 0.25-1.03, p = 0.05) for BCG versus placebo. This benefit was apparent in all subgroups, although the greatest effect was among individuals vaccinated below 15 years of age (RR = 0.40 [95% CI 0.15-1.01], p = 0.05). The addition of killed M leprae did not improve the protection afforded by a primary BCG vaccination. The rate ratio for BCG plus killed M leprae versus BCG alone among scar-negative individuals was 1.06 (0.62-1.82, p = 0.82) for all ages, though 0.37 (0.11-1.24, p = 0.09) for individuals vaccinated below 15 years of age. 376 cases of postvaccination pulmonary tuberculosis and 31 of glandular tuberculosis were ascertained by May, 1995. The rate of diagnostically certain tuberculosis was higher among scar-positive individuals who had received a second BCG (1.43 [0.88-2.35], p = 0.15) than among those who had received placebo and there was no evidence that any of the trial vaccines contributed to protection against pulmonary tuberculosis. INTERPRETATION: In a population in which a single BCG vaccination affords 50% or more protection against leprosy, but none against tuberculosis, a second vaccination can add appreciably to the protection against leprosy, without providing any protection against tuberculosis.

Adolescent↗

PubMed2005

Screening for psychosocial problems in 5-6-year olds: a randomised controlled trial of routine health assessments.

OBJECTIVE: Children's psychosocial problems are often not identified accurately. The present study addresses the effect of training of Child Health Doctors (CHDs) in a structured method to identify psychosocial problems on the accuracy of this identification in children aged 5-6. METHOD: The study was a randomised controlled trial (RCT) with a baseline and two follow-up measurements. A volunteer sample of 58 CHDs participated, randomly assigned to intervention or control condition. CHDs selected a population-based sample of 5-6-year-old children (n = 6375). RESULTS: The first follow-up showed that sensitivity had improved by 9% and specificity by 5% in the intervention condition, especially in children with severe problems (odds ratio = 3.7; 95% confidence interval: 1.2-11.8). The second follow-up showed a decrease in sensitivity and specificity in both conditions. CONCLUSION: The training improves identification of psychosocial problems, especially severe ones, although the availability of time and resources also influences the accuracy with which psychosocial problems are identified.

Adult↗

PubMed2001

The efficacy of topical anaesthesia in flexible nasendoscopy: a double-blind randomised controlled trial.

The routine use of topical anaesthesia during flexible nasendoscopy has been questioned, and the degree to which topical vasoconstrictors can affect patient discomfort has yet to be elucidated. Patients' experiences with Lignocaineand phenylephrine, Lignocaine alone, xylometazoline and no preparation were compared. One hundred patients were recruited in this double-blind, randomised control trial and put into these four groups. Each patient completed a visual analogue scoring chart to determine the severity of unpleasantness and other undesirable effects (pain, bad taste, burning, choking, numbness and difficulty in swallowing). The results confirmed that vasoconstriction is a major contributing factor towards reducing overall unpleasantness (P = 0.022), topical anaesthesia can produce a bad taste (P = 0.022), and that none of the preparations have any effect on the pain during nasendoscopy. In conclusion, xylometazoline is recommended for nasendoscopy as it is effective and is significantly cheaper than the other preparations. Not using any preparations leads to the experience of severe symptoms.

Anesthesia, Local↗

PubMed2005

A randomised controlled trial of mifepristone in combination with misoprostol administered sublingually or vaginally for medical abortion up to 13 weeks of gestation.

OBJECTIVE: To assess women's acceptability, the efficacy and side effects of sublingual versus vaginal administration of misoprostol in combination with mifepristone for medical abortion up to 13 weeks of gestation. DESIGN: Randomised controlled trial. SETTING: Aberdeen Royal Infirmary. POPULATION: Women undergoing medical abortion under the terms of the 1967 Abortion Act. METHODS: Mifepristone (200 mg) was given orally followed 36-48 hours later by misoprostol administration (sublingual: 600 microg; vaginal: 800 microg). A second dose of misoprostol 400 microg was given 3 hours later (sublingually or vaginally). Women between 9 and 13 weeks of gestation received a further (third) dose of misoprostol 400 microg (sublingually or vaginally), 3 hours later if abortion had not occurred. MAIN OUTCOME MEASURES: Women's acceptability, efficacy of the regimen and side effects experienced. RESULTS: A total of 340 women were recruited (171 sublingual and 169 vaginal). A total of 70% of women in the sublingual group expressed satisfaction with the route of misoprostol administration; 18% answered 'Don't know' while 12% were dissatisfied, compared with 68%, 28% and 4%, respectively, in the vaginal group (P= 0.02). There was no significant difference in the need for surgical evacuation for women in the sublingual (3/158, 1.9%) and vaginal groups (4/156, 2.6%) (P= 0.70). Women receiving misoprostol sublingually were more likely to experience diarrhoea (P < 0.01), shivering (P < 0.01) and unpleasant mouth taste (P < 0.01). CONCLUSIONS: Sublingual administration of misoprostol is an effective alternative to vaginal administration for medical abortion up to 13 weeks of gestation. The prevalence of prostaglandin-related side effects, however, was higher with this route of administration.

Abortifacient Agents, Nonsteroidal↗

PubMed2001

Therapeutic nursing or unblocking beds? A randomised controlled trial of a post-acute intermediate care unit.

OBJECTIVES: To compare post-acute intermediate care in an inpatient nurse-led unit with conventional post-acute care on general medical wards of an acute hospital and to examine the model of care in a nurse-led unit. DESIGN: Randomised controlled trial with six month follow up. SETTING: Urban teaching hospital and surrounding area, including nine community hospitals. PARTICIPANTS: 238 patients accepted for admission to nurse-led unit. INTERVENTIONS: Care in nurse-led unit or usual post-acute care. MAIN OUTCOME MEASURES: Patients' length of stay, functional status, subsequent move to more dependent living arrangement. RESULTS: Inpatient length of stay was significantly longer in the nurse-led unit than in general medical wards (14.3 days longer (95% confidence interval 7.8 to 20.7)), but this difference became non-significant when transfers to community hospitals were included in the measure of initial length of stay (4.5 days longer (-3.6 to 12.5)). No differences were observed in mortality, functional status, or living arrangements at any time. Patients in the nurse-led unit received significantly fewer minor medical investigations and, after controlling for length of stay, significantly fewer major reviews, tests, or drug changes. CONCLUSIONS: The nurse-led unit seemed to be a safe alternative to conventional management, but a full accounting of such units' place in the local continuum of care and the costs associated with acute hospitals managing post-acute patients is needed if nurse-led units are to become an effective part of the government's recent commitment to intermediate care.

Acute Disease↗