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Results for “Randomised Controlled Trial”

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PubMed2004

Randomised controlled trial of effect of hands and knees posturing on incidence of occiput posterior position at birth.

OBJECTIVE: To evaluate the efficacy of hands and knees position and pelvic rocking exercises on the incidence of fetal occiput posterior position at birth. DESIGN: Multicentre randomised controlled trial. SETTING: Seven maternity units in New South Wales, Australia, encompassing teaching hospitals and district general hospitals. PARTICIPANTS: 2547 pregnant women at 37 weeks' gestation; 1292 randomised to the intervention group and 1255 to the control group. INTERVENTION: Hands and knees position and pelvic rocking exercises from 37 weeks' gestation until the onset of labour. MAIN OUTCOME MEASURE: Incidence of fetal occiput posterior position at birth. RESULTS: 1046 women in the intervention group and 1209 women in the control group remained in the study until they went into labour. No significant difference existed between the groups for the incidence of occiput posterior position at birth: 105 (8.1%) women in the intervention group and 98 (7.8%) in the control group had a baby in a posterior position at delivery (difference in risk 0.3%, 95% confidence interval -1.8 to 2.4). The incidence of fetal transverse arrest was 3.4% (44 women) in the intervention group and 3.0% (38 women) in the control group (difference in risk 0.4, -1 to 1.7). No differences occurred between intervention and control groups for induction of labour, use of epidural, duration of labour, mode of delivery, use of episiotomy, or Apgar score. CONCLUSION: Hands and knees exercise with pelvic rocking from 37 weeks' gestation to the onset of labour did not reduce the incidence of persistent occiput posterior position at birth.

Adult↗

PubMed2001

Randomised controlled trial of telemedicine for new neurological outpatient referrals.

OBJECTIVE: To test the hypothesis that telemedicine for new patient referrals to neurological outpatients is as efficient and acceptable as conventional face to face consultation. METHODS: A randomised controlled trial between two groups: face to face (FF) and telemedicine (TM). This study was carried out between a neurological centre and outlying clinics at two distant hospitals linked by identical medium cost commercial interactive video conferencing equipment with ISDN lines transmitting information at 384 kbits/s. The same two neurologists carried out both arms of the study. Of the 168 patients who were suitable for the study, 86 were randomised into the telemedicine group and 82 into the face to face group. Outcome measures were (1) consultation process: (a) number of investigations; (b) number of drugs prescribed; (c) number of patient reviews and (2) patient satisfaction: (a) confidence in consultation; (b) technical aspects of consultation; (c) aspects surrounding confidentiality. Diagnostic categories were also measured to check equivalence between the groups: these were structural neurological, structural non-neurological, non-structural, and uncertain. RESULTS: Diagnostic categories were similar (p>0.5) between the two groups. Patients in the telemedicine group had significantly more investigations (p=0.001). There was no difference in the number of drugs prescribed (p>0.5). Patients were generally satisfied with both types of consultation process except for concerns about confidentiality and embarrassment in the telemedicine group (p=0.017 and p=0.005 respectively). CONCLUSION: Telemedicine for new neurological outpatients is possible and feasible but generates more investigations and is less well accepted than face to face examination.

Adolescent↗

PubMed2003

Cost effectiveness of ward based non-invasive ventilation for acute exacerbations of chronic obstructive pulmonary disease: economic analysis of randomised controlled trial.

OBJECTIVE: To evaluate the cost effectiveness of standard treatment with and without the addition of ward based non-invasive ventilation in patients admitted to hospital with an acute exacerbation of chronic obstructive pulmonary disease. DESIGN: Incremental cost effectiveness analysis of a randomised controlled trial. SETTING: Medical wards in 14 hospitals in the United Kingdom. PARTICIPANTS: The trial comprised 236 patients admitted to hospital with an acute exacerbation of chronic obstructive pulmonary disease and mild to moderate acidosis (pH 7.25-7.35) secondary to respiratory failure. The economic analysis compared the costs of treatment that these patients received after randomisation. MAIN OUTCOME MEASURE: Incremental cost per in-hospital death. RESULTS: 24/118 died in the group receiving standard treatment and 12/118 in the group receiving non-invasive ventilation (P=0.05). Allocation to the group receiving non-invasive ventilation was associated with a reduction in costs of 49362 pounds sterling (78741 dollars; 73109 euros), mainly through reduced use of intensive care units. The incremental cost effectiveness ratio was -645 pounds sterling per death avoided (95% confidence interval -2310 pounds sterling to 386 pounds sterling), indicating a dominant (more effective and less costly) strategy. Modelling of these data indicates that a typical UK hospital providing a non-invasive ventilation service will avoid six deaths and three to nine admissions to intensive care units per year, with an associated cost reduction of 12000-53000 pounds sterling per year. CONCLUSIONS: Non-invasive ventilation is a highly cost effective treatment that both reduced total costs and improved mortality in hospital.

Acute Disease↗

PubMed2005

Predicting the risk of falling--efficacy of a risk assessment tool compared to nurses' judgement: a cluster-randomised controlled trial [ISRCTN37794278].

BACKGROUND: Older people living in nursing homes are at high risk of falling because of their general frailty and multiple pathologies. Prediction of falls might lead to an efficient allocation of preventive measures. Although several tools to assess the risk of falling have been developed, their impact on clinically relevant endpoints has never been investigated. The present study will evaluate the clinical efficacy and consequences of different fall risk assessment strategies. STUDY DESIGN: Cluster-randomised controlled trial with nursing home clusters randomised either to the use of a standard fall risk assessment tool alongside nurses' clinical judgement or to nurses' clinical judgement alone. Standard care of all clusters will be optimised by structured education on best evidence strategies to prevent falls and fall related injuries. 54 nursing home clusters including 1,080 residents will be recruited. Residents must be > or = 70 years, not bedridden, and living in the nursing home for more than three months. The primary endpoint is the number of participants with at least one fall at 12 months. Secondary outcome measures are the number of falls, clinical consequences including side effects of the two risk assessment strategies. Other measures are fall related injuries, hospital admissions and consultations with a physician, and costs.

Accidental Falls↗

PubMed2005

A family support organiser for stroke patients and their carers: a randomised controlled trial.

BACKGROUND: Previous trials of interventions to support stroke survivors and their families in the community have had contradictory and inconclusive results. Using the MRC Framework for Complex Interventions we developed a family support organiser (FSO) service and refined outcome measures for evaluation. We tested the effects of the intervention in a randomised controlled trial. METHODS: From 1 March 1999 to 1 April 2001 all first-in-a-lifetime strokes (n = 513) were identified and 340 (96%) of eligible strokes randomised to receive FSO or usual care. Patients and their carers were followed up at 3 months and 1 year post-stroke. Outcomes included satisfaction (main outcome) with hospital staff and outpatient services, use of social services, reintegration to normal living (RNLI) and feelings about life after the stroke. RESULTS: The mean number of contacts with the FSO was 15 (SD = 9.8) per patient. More intervention than control patients received some social services and had increased patient and carer satisfaction in most aspects, particularly with information about recovery and feeling that someone had listened. There was little evidence at 3 or 12 months of differences in RNLI. CONCLUSIONS: A meta-analysis of trials in this area is now needed along with further trials of interventions in subgroups of the stroke population to fully identify any benefits of the FSO role.

Aged↗

PubMed2003

Does hydrotherapy improve strength and physical function in patients with osteoarthritis--a randomised controlled trial comparing a gym based and a hydrotherapy based strengthening programme.

OBJECTIVE: To compare the effects of a hydrotherapy resistance exercise programme with a gym based resistance exercise programme on strength and function in the treatment of osteoarthritis (OA). DESIGN: Single blind, three arm, randomised controlled trial. SUBJECTS: 105 community living participants aged 50 years and over with clinical OA of the hip or knee. METHODS: Participants were randomised into one of three groups: hydrotherapy (n = 35), gym (n = 35), or control (n = 35). The two exercising groups had three exercise sessions a week for six weeks. At six weeks an independent physiotherapist unaware of the treatment allocation performed all outcome assessments (muscle strength dynamometry, six minute walk test, WOMAC OA Index, total drugs, SF-12 quality of life, Adelaide Activities Profile, and the Arthritis Self-Efficacy Scale). RESULTS: In the gym group both left and right quadriceps significantly increased in strength compared with the control group, and right quadriceps strength was also significantly better than in the hydrotherapy group. The hydrotherapy group increased left quadriceps strength only at follow up, and this was significantly different from the control group. The hydrotherapy group was significantly different from the control group for distance walked and the physical component of the SF-12. The gym group was significantly different from the control group for walk speed and self efficacy satisfaction. Compliance rates were similar for both exercise groups, with 84% of hydrotherapy and 75% of gym sessions attended. There were no differences in drug use between groups over the study period. CONCLUSION: Functional gains were achieved with both exercise programmes compared with the control group.

Aged↗

PubMed2003

Empirical prescribing for dyspepsia: randomised controlled trial of test and treat versus omeprazole treatment.

OBJECTIVE: To compare the efficacy of a "Helicobacter pylori test and treat" strategy with that of an empirical trial of omeprazole in the non-endoscopic management by empirical prescribing of young patients with dyspepsia. DESIGN: Randomised controlled trial. SETTING: Hospital gastroenterology unit. PARTICIPANTS: 219 patients under 45 years old presenting with dyspepsia without alarm symptoms. INTERVENTION: Patients received treatment with omeprazole 20 mg (group A) or with a urea breath test followed by an eradication treatment in case of H pylori infection or omeprazole alone in non-infected patients (group B). Lack of improvement or recurrence of symptoms prompted endoscopy. MAIN OUTCOME MEASURES: Improvement in symptoms assessed by a dyspepsia severity score every two months; use of medical resources (endoscopic workload and medical consultation); clinical outcome. RESULTS: 96/109 (88%) patients in group A and 61/110 (55%) in group B (P < 0.0001) had endoscopy: in 19 patients in group A and 32 in group B (20/67 infected and 12/43 non-infected) because of no improvement; in 77 further patients in group A and 29 in group B (7 infected and 22 non-infected) because of recurrence of symptoms during follow up. Endoscopy showed peptic ulcers only in group A; oesophagitis occurred significantly more often in group B than in group A. About 80% of examinations were normal in both groups, but nine duodenal scars occurred in group A. CONCLUSIONS: Eradication treatment allows resolution of symptoms in a large number of patients with dyspepsia and reduces the endoscopic workload. After a trial of omeprazole, symptoms recur in nearly every patient. Such treatment is also likely to mask an appreciable number of peptic ulcers and cases of oesophagitis.

Adult↗

PubMed2006

Comprehension of discharge information for minor head injury: a randomised controlled trial in New Zealand.

AIMS: To investigate health literacy (i.e. understanding medical information) in North Shore Hospital's Emergency Medicine Department patients and to assess differences in comprehension between standard and simplified head injury advice sheets. METHODS: Prospective randomised controlled trial in a convenience sample of adult Emergency Medicine patients presenting to an urban emergency department (ED) in New Zealand. Consented patients were randomised to receive either the standard head injury advice sheet or a shorter, simplified sheet. Participants were asked 10 questions (to test comprehension of advice sheets), demographic data collected, and a Rapid Estimation of Adult Literacy in Medicine test administered. Data analysis included descriptive statistics with 95% confidence intervals, Mann Whitney U test, and regression model analysis. RESULTS: 200 participants. Mean age 43.4 years, 77.5% with 12 or more years of schooling, 84.5% with reading level of high school age or above. No significant differences in demographics, schooling, and reading levels were observed between study groups. The simplified form study group showed significantly higher comprehension scores (p<0.0001). In the regression analysis, factors associated with higher comprehension scores included: the simplified form, higher literacy level, more years of schooling, and younger age group. CONCLUSIONS: Previous studies have highlighted poor literacy levels in ED populations, a factor thought to affect understanding of discharge information. In this study population, where most read at high school level or above, the simplified advice sheet was still better understood. Recommendations for improving discharge information are discussed.

Adult↗

PubMed2002

Prevention of postpartum stress incontinence in primigravidae with increased bladder neck mobility: a randomised controlled trial of antenatal pelvic floor exercises.

OBJECTIVE: To test whether supervised pelvic floor exercises antenatally will reduce the incidence of postpartum stress incontinence in at-risk primigravidae with bladder neck mobility, ultrasonically proven. DESIGN: Single blind, randomised controlled trial. SETTING: Antenatal clinic in a UK NHS Trust Hospital. SAMPLE: Two hundred and sixty-eight primigravidae attending an antenatal clinic at approximately 20 weeks of gestation with bladder neck mobility, on standardised valsalva, of 5 mm or more linear movement. The median age was 28, ranging from 16 to 47 years. INTERVENTION: Patients randomised to supervised pelvic floor exercises (n = 139) attended a physiotherapist at monthly intervals from 20 weeks until delivery. The exercises comprised three repetitions of eight contractions each held for six seconds, with two minutes rest between repetitions. These were repeated twice daily. At 34 weeks of gestation the number of contractions per repetition was increased to 12. Both the untreated control group and the study group received verbal advice on pelvic floor exercises from their midwives antenatally. MAIN OUTCOME MEASURES: Subjective reporting of stress incontinence at three months postpartum. Pelvic floor strength, using perineometry, and bladder neck mobility measured by perineal ultrasound. RESULTS: Of the 268 women enrolled, information on the main outcome variable was available for 110 in the control group and 120 in the study group. Fewer women in the supervised pelvic floor exercise group reported postpartum stress incontinence, 19.2% compared with 32.7% in the control group (RR 0.59 [0.37-0.92]). There was no change in bladder neck mobility and no difference in pelvic floor strength between groups after exercise, although all those developing postpartum stress incontinence had significantly poorer perineometry scores than those who were continent. CONCLUSIONS: The findings suggest that antenatal supervised pelvic floor exercises are effective in reducing the risk of postpartum stress incontinence in primigravidae with bladder neck mobility.

Adolescent↗

PubMed1999

Reducing the risk of major elective surgery: randomised controlled trial of preoperative optimisation of oxygen delivery.

OBJECTIVES: To determine whether preoperative optimisation of oxygen delivery improves outcome after major elective surgery, and to determine whether the inotropes, adrenaline and dopexamine, used to enhance oxygen delivery influence outcome. DESIGN: Randomised controlled trial with double blinding between inotrope groups. SETTING: York District Hospital, England. SUBJECTS: 138 patients undergoing major elective surgery who were at risk of developing postoperative complications either because of the surgery or the presence of coexistent medical conditions. INTERVENTIONS: Patients were randomised into three groups. Two groups received invasive haemodynamic monitoring, fluid, and either adrenaline or dopexamine to increase oxygen delivery. Inotropic support was continued during surgery and for at least 12 hours afterwards. The third group (control) received routine perioperative care. MAIN OUTCOME MEASURES: Hospital mortality and morbidity. RESULTS: Overall, 3/92 (3%) preoptimised patients died compared with 8/46 controls (17%) (P=0.007). There were no differences in mortality between the treatment groups, but 14/46 (30%) patients in the dopexamine group developed complications compared with 24/46 (52%) patients in the adrenaline group (difference 22%, 95% confidence interval 2% to 41%) and 28 patients (61%) in the control group (31%, 11% to 50%). The use of dopexamine was associated with a decreased length of stay in hospital. CONCLUSION: Routine preoperative optimisation of patients undergoing major elective surgery would be a significant and cost effective improvement in perioperative care.

Aged↗

PubMed2006

Oral versus self-administered vaginal misoprostol at home before surgical termination of pregnancy: a randomised controlled trial.

OBJECTIVE: To compare the impact of 400 mug oral versus self-administered vaginal misoprostol at home on pre-operative cervical priming in both primigravid and multigravid women prior to first trimester surgical abortion. DESIGN: Randomised controlled trial. SETTING: Norwegian University Teaching Hospital. SAMPLE: Three hundred and thirty-eight women undergoing surgical abortion between 7 and 12 weeks of gestation. METHODS: The women were randomised to either 400 microg of oral misoprostol the evening before or 400-microg of self-administered vaginal misoprostol at home the same day as vacuum aspiration. Main outcome measures Pre-operative cervical dilatation, complications and acceptability. RESULTS: The median cervical dilatation was 6.2 mm (range 0-11 mm) for the women in the 400 mug oral misoprostol and 6.5 mm (range 0-11 mm) in the 400-microg vaginal misoprostol groups. The median pre-operative dilatation was larger in multigravidae (6.4 and 6.7 mm for the oral and vaginal routes, respectively) than in primigravidae (5.8 and 6.0 mm, respectively). In primigravidae, 19% achieved a pre-operative dilatation of > or = 7 mm, with no significant difference between oral and vaginal dosage. In multigravidae, 52% achieved a pre-operative dilatation of > or = 7 mm with vaginal dosage, compared with 36% with oral dosage (P = 0.03). There was no difference between non-immigrant versus immigrant women in pre-operative cervical dilatation. The 400-microg oral dosage group had a higher risk of bleeding, compared with the group receiving 400-microg vaginal misoprostol [odds ratio (OR) = 10.4; confidence interval (CI) 5.2-20.8]. There was no difference between non-immigrant and immigrant women in acceptability of self-administered vaginal misoprostol; almost all women found this administration route acceptable. Complications were minor and were distributed equally between the two dosage groups. CONCLUSIONS: The vaginal route will result in a satisfactory dilatation in about half of multigravidae but is much less effective in primigravidae. The oral route does not lead to satisfactory dilatation in either group and is associated with a higher occurrence of pre-operative bleeding. Self-administered vaginal misoprostol at home is highly acceptable.

Abortifacient Agents, Nonsteroidal↗

PubMed2005

Local anaesthetic flush reduces postoperative pain and haematoma formation after great saphenous vein stripping--a randomised controlled trial.

OBJECTIVES: To observe the effect of local anaesthetic flush through the great saphenous vein (GSV) tunnel on postoperative pain and haematoma formation following saphenous vein stripping operations. DESIGN: Prospective, double-blind, randomised, control trial. METHODS: One hundred patients were randomized to receive 20 ml of local anaesthetic (bupivacaine 0.25% + adrenaline) or saline control flush through the GSV tunnel after stripping in a double-blind study. Visual analogue pain scores were used to measure postoperative pain daily for the 1st week, then at 3 weeks and 6 weeks. Patients were examined during the 1st, 3rd and 6th week for haematoma formation. RESULTS: In the control group the median postoperative pain score was 4 (range 0-7) in the immediate postoperative period compared to a median of 1 (range 0-4) in the LA group (p<0.001). The median pain score on day-4 was 4 (range 1-6) (control) vs. 1 (range 0-3) (LA group) (p<0.001, Mann-Whitney Utest) and on day-6 it was 1 (range 0-5) (control) vs. 0 (range 0-5) (LA group) (p<0.001, Mann-Whitney). Twelve patients (24%) developed a haematoma in the GSV tunnel in the control group compared to three patients (6%) in the LA group (p = 0.007). CONCLUSION: Flushing of the GSV tunnel with bupivacaine plus adrenaline significantly reduces postoperative pain and haematoma formation in patients undergoing GSV stripping for varicose veins.

Adult↗

PubMed2006

The efficacy of acupuncture in the treatment of temporomandibular joint myofascial pain: a randomised controlled trial.

OBJECTIVES: To compare the effect of real acupuncture and sham acupuncture in the treatment of temporomandibulat joint myofascial pain, in order to establish the true efficacy of acupuncture. METHODS: A double blind randomised controlled trial conducted in the TMD Clinic, at the School of Dentistry, The University of Manchester. Twenty-seven patients were assigned to one of two treatment groups. Group 1 received real acupuncture treatment whilst Group 2 received a sham acupuncture intervention. Both the assessor and the patient were blinded regarding the group allocation. Baseline assessment of the outcome variables was made prior to the first treatment session, and was repeated following the last treatment. RESULTS: The results demonstrated that real acupuncture had a greater influence on clinical outcome measure of TMJ MP than those of sham acupuncture, and the majority of these reached a level of statistical significance. CONCLUSION: Acupuncture had a positive influence on the signs and symptoms of TMJ MP. In addition, this study provides evidence that the Park Sham Device was a credible acupuncture control method for trials involving facial acupoints.

Acupuncture Therapy↗

PubMed2003

The use of postal reminders to reduce non-attendance at an orthodontic clinic: a randomised controlled trial.

OBJECTIVES: To evaluate the effect of issuing a patient reminder plus a confirmation slip on the attendance of orthodontic new patients. SETTING: Department of Orthodontics, University Dental Hospital of Manchester. DESIGN: A randomised controlled trial. METHODS: New patients were randomly allocated to:receive a reminder letter and return a confirmation slip ornot receive a reminder. OUTCOME MEASURES: Patient attendance at the clinic. RESULTS: A total of 232 patients were entered into the study between June 18, 2001 and August 29, 2001. These were randomly allocated to 115 (49.8%) in the reminder group and 116 (50.2%) in the no reminder group. If the patient received a reminder and returned the confirmation they were less likely to fail the appointment than if they did not receive a reminder (OR 0.4, 95% CI 0.2 to 0.96) There was an effect of social deprivation, if the patients lived in an area of high social deprivation they were 2.7 (95% CI 1.1 to 6.5) times more likely to fail to attend an appointment than people who were more affluent. CONCLUSIONS: The use of postal reminders for orthodontic consultation appointments appears to result in a useful increase of appointments that are kept or cancelled in advance.

Appointments and Schedules↗

PubMed1999

A randomised controlled trial comparing transvaginal ultrasound, outpatient hysteroscopy and endometrial biopsy with inpatient hysteroscopy and curettage.

OBJECTIVE: To compare the use of outpatient and inpatient procedures in the investigation of abnormal uterine bleeding. DESIGN: A randomised controlled trial. SETTING: Two university teaching hospitals. PARTICIPANTS: Four hundred women with abnormal uterine bleeding (postmenopausal bleeding, menorrhagia, intermenstrual bleeding, postcoital bleeding, or irregular periods) above the age of 35 years, between June 1993 and January 1995. MAIN OUTCOME MEASURES: 1. Incidence of detection of abnormal pathology by vaginal ultrasound, outpatient hysteroscopy and endometrial biopsy compared with inpatient hysteroscopy and curettage; 2. Number of 'lesions' (e.g. fibroids, polyps, endometrial hyperplasia or malignancy) found by hysteroscopy that would have been missed by the combination of endometrial sampling and ultrasound; 3. Comparison of the quality of tissue obtained for histology by outpatient endometrial sampling and inpatient curettage; and 4. An evaluation of patient acceptability of outpatient and inpatient procedures. RESULTS: 1. A combination of transvaginal sonography, Pipelle endometrial biopsy and outpatient hysteroscopy has similar efficacy to inpatient hysteroscopy and curettage for the investigation of abnormal uterine bleeding; 2. Hysteroscopy will detect some fibroids and polyps missed by a combination of transvaginal ultrasound and Pipelle endometrial sampling; 3. The quality of histological samples obtained by outpatient Pipelle were comparable to those obtained by formal inpatient curettage; and 4. Outpatient procedures were well tolerated, with good patient acceptability. CONCLUSION: Transvaginal sonography and endometrial biopsy can safely be used as the initial investigations in the management of abnormal uterine bleeding. Hysteroscopy can be used as a second line investigation. Outpatient hysteroscopy with local anaesthesia is well tolerated although general anesthesia may occasionally be necessary.

Adult↗

PubMed2004

Delivering an effective outpatient service in gynaecology. A randomised controlled trial analysing the cost of outpatient versus daycase hysteroscopy.

OBJECTIVE: To examine the cost implications of outpatient versus daycase hysteroscopy to the National Health Service, the patient and their employer. DESIGN AND INTERVENTIONS: Randomised controlled trial. SETTING: The gynaecology clinic of a large teaching hospital. PARTICIPANTS: Ninety-seven women with abnormal uterine bleeding requiring investigation. METHODS: Women were randomly allocated to either outpatient or daycase hysteroscopy. They were asked to complete diaries recording expenses and time off work. The National Health Service costs were calculated for a standard outpatient and daycase hysteroscopy. MAIN OUTCOME MEASURES: Costs to the National Health Service, costs to the employer, loss of income, childcare costs and travel expenses. RESULTS: The outpatient group required significantly less time off work compared with the daycase group (0.8 days vs 3.3 days), P < 0.001. Of those women who lost income due to the hysteroscopy, the average loss of income was twice as much in the daycase group ( pound 20.40 in the outpatient group vs pound 50.60 in the daycase group). The average cost of childcare required to cover the time spent in hospital undergoing the hysteroscopy was similar in both groups, however, the number of women requiring childcare was small. Travel costs incurred by the women were 74% more in the daycase group compared with the outpatient group-with an average cost of pound 3.46 in the outpatient group and pound 6.02 in the daycase group. Daycase hysteroscopy costs the National Health Service approximately pound 53.88 more per patient, than performing an outpatient hysteroscopy. Purchasing the hysteroscopes necessary to perform an outpatient hysteroscopy is a more expensive outlay than those required for daycase hysteroscopy. However, there are so many other savings that only 38 patients need to undergo outpatient hysteroscopy (even with a 4% failure rate) rather than daycase hysteroscopy in order to recoup the extra money required to set up an outpatient hysteroscopy service. CONCLUSION: Outpatient hysteroscopy offers many benefits over its traditional counterpart including faster recovery, less time away from work and home and cost savings to the woman and her employer and the National Health Service. Resources need to be made available to rapidly develop this service across the UK in order to better serve both patient and taxpayer.

Ambulatory Care↗

PubMed1998

Randomised controlled trial of tyrosine supplementation on neuropsychological performance in phenylketonuria.

OBJECTIVE: To test the efficacy of tyrosine supplementation, as an adjunct to dietary treatment, on neuropsychological test performance in individuals with phenylketonuria. DESIGN: A randomised controlled trial of tyrosine supplementation using a double blind crossover procedure with three four week phases. SETTING: The Hospital for Sick Children, Toronto. PARTICIPANTS: 21 individuals with phenylketonuria (ages 6 to 28 years, mean 11.3). INTERVENTION: Participants were given 100 mg/kg body weight/d of L-tyrosine or L-alanine (placebo). RESULTS: At baseline, performance on several of the neuropsychological test measures was correlated with tyrosine levels. Dietary supplements of tyrosine increased plasma tyrosine concentrations; however, no change in test performance was found across the tyrosine and placebo phases of the study. CONCLUSIONS: Tyrosine supplementation of this type does not appear to alter neuropsychological performance in individuals with phenylketonuria.

Administration, Oral↗

PubMed2004

Fibromyalgia: a randomised, controlled trial of a treatment programme based on self management.

OBJECTIVE: To evaluate the efficacy of a treatment programme for patients with fibromyalgia (FM) based on self management, using pool exercises and education. METHODS: Randomised controlled trial with a 6 month follow up to evaluate an outpatient multidisciplinary programme; 164 patients with FM were allocated to an immediate 6 week programme (n = 84) or to a waiting list control group (n = 80). The main outcomes were changes in quality of life, functional consequences, patient satisfaction and pain, using a combination of patient questionnaires and clinical examinations. The questionnaires included the Fibromyalgia Impact Questionnaire (FIQ), Psychological General Well-Being (PGWB) index, regional pain score diagrams, and patient satisfaction measures. RESULTS: 61 participants in the treatment group and 68 controls completed the programme and 6 month follow up examinations. Six months after programme completion, significant improvements in quality of life and functional consequences of FM were seen in the treatment group as compared with the controls and as measured by scores on both the FIQ (total score p = 0.025; fatigue p = 0.003; depression p = 0.031) and PGWB (total score p = 0.032; anxiety p = 0.011; vitality p = 0.013,). All four major areas of patient satisfaction showed greater improvement in the treatment than the control groups; between-group differences were statistically significant for "control of symptoms", "psychosocial factors", and "physical therapy" No change in pain was seen. CONCLUSION: A 6 week self management based programme of pool exercises and education can improve the quality of life of patients with FM and their satisfaction with treatment. These improvements are sustained for at least 6 months after programme completion.

Adult↗