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PubMed2026

Comparison of Traditional Chinese Exercise and Equipment-Based Exercise on Glycaemic Control and Vitamin D Levels in Middle-Aged and Elderly Patients With Prediabetes: A Randomised Controlled Trial.

BACKGROUND: Prediabetes is a critical window for preventing progression to type 2 diabetes mellitus (T2DM). Both vitamin D deficiency and physical inactivity are associated with impaired glucose metabolism. This study compared the effects of Traditional Chinese Exercise (TCE) and Kuanle Equipment Exercise (KEE) on glycaemic measures, lipid profiles, body composition and serum 25-hydroxyvitamin D3 [25(OH)D3] in middle-aged and elderly adults with prediabetes. METHODS: We conducted a 12-week, single-centre, randomised controlled trial involving 62 participants with prediabetes (mean age 55.2 ± 8.4 years; 88.7% female). Participants were randomly assigned to control (usual care, n = 21), TCE (n = 20), or KEE (n = 21). Primary outcomes included fasting plasma glucose (FPG), 2-h OGTT glucose, glycated haemoglobin (HbA1c) and serum 25(OH)D3. Secondary outcomes comprised triglycerides, total cholesterol, LDL-C, HDL-C and body composition. RESULTS: At baseline, mean serum 25(OH)D3 was 21.53 ± 3.90 nmol/L. At 12 weeks, both TCE and KEE improved FPG, 2-h OGTT glucose, HbA1c and 25(OH)D3 versus control (all p ≤ 0.001). Relative changes in FPG were -9.4% (TCE) and -15.2% (KEE) versus -1.5% (control); corresponding changes were -14.6% and -21.2% for 2-h OGTT glucose, -6.7% and -12.9% for HbA1c, and +60.6% and +81.9% for 25(OH)D3. Direct TCE-KEE comparisons were not significant (all p > 0.05). In an exploratory analysis, change in 25(OH)D3 was inversely associated with change in 2-h OGTT glucose (partial r = -0.358, p = 0.006), but not with FPG, HbA1c, or triglycerides. CONCLUSIONS: Both TCE and KEE improved glycaemic outcomes and increased serum 25(OH)D3 compared with usual care in middle-aged and elderly adults with prediabetes. Although KEE produced numerically larger estimates, direct between-group comparisons were not significant, and the superiority of KEE over TCE was not established. These vitamin D findings require confirmation in trials that quantify sunlight exposure and dietary vitamin D intake.

Aged↗

PubMed2004

A cluster randomised controlled trial to evaluate a policy of making hip protectors available to residents of nursing homes.

OBJECTIVES: to evaluate the effectiveness of a policy of making hip protectors available to residents of nursing homes. DESIGN: a cluster randomised controlled trial of the policy in nursing and residential homes, with the home as the unit of randomisation. SETTING: 127 nursing and residential homes in the greater Belfast area of Northern Ireland. PARTICIPANTS: 40 homes in the intervention group (representing 1,366 occupied beds) and 87 homes in the control group (representing 2,751 occupied beds). INTERVENTIONS: a policy of making hip protectors available free of charge to residents of nursing homes and supporting the implementation process by employing a nurse facilitator to encourage staff in the homes to promote their use, over a 72-week period. MAIN OUTCOME MEASURES: the rate of hip fractures in intervention and control homes, and the level of adherence to use of hip protectors. RESULTS: there were 85 hip fractures in the intervention homes and 163 in the control homes. The mean fracture rate per 100 residents was 6.22 in the intervention homes and 5.92 in the control homes, giving an adjusted rate ratio for the intervention group compared to the control group of 1.05 (95% CI 0.77, 1.43, P = 0.76). Initial acceptance of the hip protectors was 37.2% (508/1,366) with adherence falling to 19.9% (272/1,366) at 72 weeks. CONCLUSIONS: making hip protectors available to residents of nursing and residential homes did not reduce the rate of hip fracture. This research does not support the introduction of a policy of providing hip protectors to residents of nursing homes.

Accidental Falls↗

PubMed2005

Randomised controlled trial of qigong in the treatment of mild essential hypertension.

Exercise and relaxation decrease blood pressure. Qigong is a traditional Chinese exercise consisting of breathing and gentle movements. We conducted a randomised controlled trial to study the effect of Guolin qigong on blood pressure. In all, 88 patients with mild essential hypertension were recruited from the community and randomised to Goulin qigong or conventional exercise for 16 weeks. The main outcome measurements were blood pressure, health status (SF-36 scores), Beck Anxiety and Depression Inventory scores. In the qigong group, blood pressure decreased significantly from 146.3+/-7.8/93.0+/-4.1 mmHg at baseline to 135.5+/-10.0/87.1+/-7.7 mmHg at week 16. In the exercise group, blood pressure also decreased significantly from 140.9+/-10.9/93.1+/-3.5 mmHg to 129.7+/-11.1/86.0+/-7.0 mmHg. Heart rate, weight, BMI, waist circumference, total cholesterol, renin and 24 h urinary albumin excretion significantly decreased in both groups after 16 weeks. General health, bodily pain, social functioning and depression also improved in both groups. No significant differences between qigong and conventional exercise were found. In conclusion, Guolin qigong and conventional exercise have similar effects on blood pressure in patients with mild hypertension. While no additional benefits were identified, it is nevertheless an alternative to conventional exercise in the nondrug treatment of hypertension.

Aged↗

PubMed2006

A pragmatic, three-arm randomised controlled trial of spiritual healing for asthma in primary care.

BACKGROUND: Well-designed trials are required to assess if complementary and alternative medicine (CAM) is effective. AIM: This study assessed the effectiveness of spiritual healing for asthma. DESIGN OF STUDY: Randomised, placebo-controlled trial. SETTING: Aberdeen, Scotland. METHOD: This was a single-blind, three-armed randomised, controlled trial of spiritual healing for asthma, comparing the effectiveness of five sessions of spiritual healing with placebo (delivered by an actor), and with a control group receiving normal care only. The primary outcome measure was the Juniper Asthma Quality of Life Questionnaire (AQLQ). Secondary outcomes were forced expiratory flow in one second (FEV1), peak expiratory flow (PEF), HADS (Hospital Anxiety Depression Scale), SF-36 and MYMOP (Measure Yourself Medical Outcome Profile). Baseline and follow-up data were collected. RESULTS: Eighty-eight adult patients receiving pharmacological treatment for asthma participated. AQLQ scores improved significantly from baseline and the end of treatment in all groups (spiritual healing P = 0.008; 'sham' healing P = 0.001 and control P = 0.01) but there was no significant difference between groups (P = 0.57). These improvements were maintained at follow-up 1 for two of the groups (spiritual healing P = 0.016; sham healing P = 0.001 and control P = 0.09) but none of the groups showed an improvement at follow-up 2 (spiritual healing P = 0.161; sham healing P = 0.016 and control P = 0.11). Similar proportions of patients in each group showed a clinically important improvement in AQLQ score. Analysis of AQLQ scores at end of treatment and both follow-up periods indicated no significance between group differences. No consistent changes were seen in secondary outcome measures, possibly due to the small sample size. CONCLUSION: Spiritual healing does not appear to have any specific affect on patient asthma related quality of life.

Adult↗

PubMed2003

Effectiveness of psychoeducational intervention for rural Chinese families experiencing schizophrenia--a randomised controlled trial.

BACKGROUND: The aim of this study was to explore the characteristics and efficacy of psychoeducational family intervention for persons with schizophrenia in rural China. METHODS: A cluster randomised controlled trial of psychoeducational family intervention for families experiencing schizophrenia (three groups, 326 cases) was conducted in Xinjin County, Chengdu. Treatment groups consisted of family intervention and medication, medication alone, and a control. RESULTS: The results showed a gain in knowledge, a change in the relatives' caring attitudes towards the patients, and an increase in treatment compliance in the psychoeducational family intervention group (p < 0.05, 0.001). Most importantly, the relapse rate over 9 months in this group (16.3 %) was half that of the drug-only group (37.8 %), and just over one-quarter of that of the control group (61.5 %) (p < 0.05). Antipsychotic drug treatment and families' attitudes towards patients after the 9-month follow-up were significantly associated with clinical outcome (p < 0.05). CONCLUSIONS: In rural China, family intervention should focus on improving the relatives' recognition of illness, the caring attitude towards the patients, treatment compliance, relapse prevention, and the training of the patients' social functioning. This trial, one of the largest in the literature, has shown that psychoeducational family intervention is effective and suitable for psychiatric rehabilitation in Chinese rural communities.

Adult↗

PubMed2006

Twelve weeks of nightly stretch does not reduce thumb web-space contractures in people with a neurological condition: a randomised controlled trial.

QUESTION: What is the effectiveness of 12 weeks of nightly stretch in reducing thumb web-space contracture in people with neurological conditions? DESIGN: Assessor-blinded, randomised controlled trial. PARTICIPANTS: Forty-four (one dropout)community-dwelling patients with a neurological condition (14 stroke, 7 traumatic brain injury, 23 spinal cord injury) who had uni or bilateral thumb web-space contractures (60 thumbs). INTERVENTION: The experimental thumbs were splinted into a stretched,abducted position each night for 12 weeks. The control thumbs were not splinted. OUTCOME MEASURES: Thumb web-space was measured as the carpometacarpal angle during the application of a 0.9 Nm abduction torque before and after intervention. RESULTS: The mean increase in thumb web-space after 12 weeks was 1 deg (95% CI, -1 to 2). CONCLUSION: Intensive stretch administered regularly over three months does not reduce thumb web-space contractures in neurological conditions.

Adult↗

PubMed2001

Narrow-band ultraviolet B and broad-band ultraviolet A phototherapy in adult atopic eczema: a randomised controlled trial.

BACKGROUND: Narrow-band ultraviolet B (UVB) is an effective treatment for psoriasis, and open studies suggest that this phototherapy might improve atopic eczema. We did a randomised controlled trial to compare narrow-band UVB, UVA, and visible light phototherapy as second-line, adjunctive treatments in adult patients with moderate to severe atopic eczema. METHODS: Phototherapy was administered twice a week for 12 weeks. 26 patients were randomly assigned narrow-band UVB, 24 were assigned UVA, and 23 visible fluorescent light. The primary endpoints were change in total disease activity (sum of scores at six body sites) and change in extent of disease after 24 treatments compared with baseline. Data were analysed by the method of summary measures. FINDINGS: 13 patients withdrew or were excluded from analysis. Mean reductions in total disease activity over 24 treatments in patients who received narrow-band UVB and UVA, respectively, were 9.4 points (95% CI 3.6 to 15.2) and 4.4 points (-1.0 to 9.8) more than in patients who received visible light. Mean reductions in extent of disease after 24 treatments with narrow-band UVB and UVA were 6.7% (1.5 to 11.9) and -1.0% (-5.3 to 3.3) compared with visible light. A small proportion of patients developed erythema after phototherapy or had a flare in their eczema sufficient to withdraw from treatment. INTERPRETATION: Narrow-band UVB is an effective adjunctive treatment for moderate to severe atopic eczema, and the treatment is well tolerated by most patients.

Adolescent↗

PubMed2005

Short-term androgen deprivation and radiotherapy for locally advanced prostate cancer: results from the Trans-Tasman Radiation Oncology Group 96.01 randomised controlled trial.

BACKGROUND: Androgen deprivation is an established treatment regimen for disseminated prostate cancer; however, its role in patients with localised cancer is less clear. We did a large randomised controlled trial to determine whether 3 months or 6 months of androgen deprivation given before and during radiotherapy improves outcomes for patients with locally advanced prostate cancer. METHODS: 818 men with locally advanced prostate cancer were randomly assigned to: no androgen deprivation (ie, radiotherapy alone: 66 Gy in 33 fractions of 2 Gy per day over 6.5-7.0 weeks to the prostate and seminal vesicles); 3 months' androgen deprivation with 3.6 mg goserelin given subcutaneously every month and 250 mg flutamide given orally three times a day starting 2 months before radiotherapy (same regimen as control group); or 6 months' androgen deprivation, with the same regimen, starting 5 months before radiotherapy (same regimen as control group). Primary endpoints were time to local failure and prostate-cancer-specific survival; secondary endpoints were distant failure, disease-free survival, and freedom from salvage treatment. Analyses were done by intention to treat. FINDINGS: 802 (98%) patients were eligible for analysis. Median follow-up was 5.9 years (range 0.1-8.5). Compared with patients assigned no androgen deprivation, those assigned 3 months' treatment had significantly improved local failure (hazard ratio [HR] 0.56 [95% CI 0.39-0.79], p=0.001), biochemical failure-free survival (0.70 [0.56-0.88], p=0.002), disease-free survival (0.65 [0.52-0.80], p=0.0001), and freedom from salvage treatment (0.73 [0.56-0.96], p=0.025). 6 months' androgen deprivation significantly improved local failure (0.42 [0.28-0.62], p<0.0001), biochemical failure-free survival (0.58 [0.46-0.74], p<0.0001), disease-free survival (0.56 [0.45-0.69], p<0.0001), freedom from salvage treatment (0.53 [0.40-0.71], p<0.0001), distant failure (0.67 [0.45-0.99], p=0.046) and prostate-cancer-specific survival (0.56 [0.32-0.98], p=0.04) compared with no androgen deprivation. INTERPRETATION: 6 months' androgen deprivation given before and during radiotherapy improves the outlook of patients with locally advanced prostate cancer. Further follow-up is needed to estimate precisely the size of survival benefits. Increased radiation doses and additional periods of androgen deprivation might lead to further benefit.

Adenocarcinoma↗

PubMed1991

Topical glyceryl trinitrate and eutectic mixture of local anaesthetics in children. A randomised controlled trial on choice of site and ease of venous cannulation.

One hundred and four children aged between 1 and 11 years were studied in a double-blind randomised controlled trial of glyceryl trinitrate ointment versus placebo, when used in addition to standard eutectic mixture of local anaesthetics cream. Each child received glyceryl trinitrate ointment on one hand and placebo on the other, and thus acted as his/her own control. A group of 30 children who received only the eutectic mixture on both hands (60 measurements) was also studied. The choice of site and ease of cannulation was scored. Skin colour and venous dilatation under the eutectic mixture were scored on a visual analogue scale. The addition of topical glyceryl trinitrate ointment to the standard eutectic mixture positively affected venous dilatation (p less than 0.01), choice of cannulation site (p less than 0.001), and ease of cannulation (p less than 0.001) of topical anaesthetic-treated skin.

Administration, Topical↗

PubMed1993

Randomised controlled trial comparing endometrial resection with abdominal hysterectomy for the surgical treatment of menorrhagia.

OBJECTIVE: To evaluate the effectiveness of endometrial resection as a surgical treatment for menorrhagia. DESIGN: Randomised controlled trial. SETTING: Gynaecology department at a teaching hospital. SUBJECTS: Two hundred women needing surgical treatment for menorrhagia between January 1990 and May 1991. After withdrawal of four women 97 underwent hysterectomy and 99 underwent endometrial resection. MAIN OUTCOME MEASURES: Patient satisfaction 4 months after surgery; post-operative complications; length of hospital stay; duration of time before return to work, normal daily activities and sexual intercourse; change in premenstrual symptoms. RESULTS: The difference in patient satisfaction between endometrial resection (84 out of 99) and abdominal hysterectomy (89 out of 95) just reached statistical significance in favour of abdominal hysterectomy at 4 months after surgery (difference = 9%, 95% confidence intervals (CI) 1.1%-17.5%). Post-operative morbidity, length of hospital stay and time taken to return to work, normal daily activities and sexual intercourse were significantly less in the endometrial resection group. However, the premenstrual symptoms of dysmenorrhoea, bloating and breast tenderness were less frequent after hysterectomy. CONCLUSION: In the short term, endometrial resection was almost as satisfactory as abdominal hysterectomy for the surgical treatment of menorrhagia, and was associated with less morbidity. However, even at 4 months after surgery, there was a failure rate of at least 10% in those in whom endometrial resection appeared complete. Longer term comparative studies are necessary before the widespread introduction of endometrial resection as an alternative to abdominal hysterectomy for the surgical treatment of menorrhagia.

Activities of Daily Living↗

PubMed1997

Randomised controlled trial of graded exercise in patients with the chronic fatigue syndrome.

OBJECTIVE: To test the efficacy of a graded aerobic exercise programme in the chronic fatigue syndrome. DESIGN: Randomised controlled trial with control treatment crossover after the first follow up examination. SETTING: Chronic fatigue clinic in a general hospital department of psychiatry. SUBJECTS: 66 patients with the chronic fatigue syndrome who had neither a psychiatric disorder nor appreciable sleep disturbance. INTERVENTIONS: Random allocation to 12 weeks of either graded aerobic exercise or flexibility exercises and relaxation therapy. Patients who completed the flexibility programme were invited to cross over to the exercise programme afterwards. MAIN OUTCOME MEASURE: The self rated clinical global impression change score, "very much better" or "much better" being considered as clinically important. RESULTS: Four patients receiving exercise and three receiving flexibility treatment dropped out before completion. 15 of 29 patients rated themselves as better after completing exercise treatment compared with eight of 30 patients who completed flexibility treatment. Analysis by intention to treat gave similar results (17/33 v 9/33 patients better). Fatigue, functional capacity, and fitness were significantly better after exercise than after flexibility treatment. 12 of 22 patients who crossed over to exercise after flexibility treatment rated themselves as better after completing exercise treatment 32 of 47 patients rated themselves as better three months after completing supervised exercise treatment 35 of 47 patients rated themselves as better one year after completing supervised exercise treatment. CONCLUSION: These findings support the use of appropriately prescribed graded aerobic exercise in the management of patients with the chronic fatigue syndrome.

Adult↗

PubMed1999

Randomised controlled trial of effect of feedback on general practitioners' prescribing in Australia.

OBJECTIVE: To evaluate the effect on general practitioners' prescribing of feedback on their levels of prescribing. DESIGN: Randomised controlled trial. SETTING: General practice in rural Australia. PARTICIPANTS: 2440 full time recognised general practitioners practising in non-urban areas. INTERVENTION: Two sets of graphical displays (6 months apart) of their prescribing rates for 2 years, relative to those of their peers, were posted to participants. Data were provided for five main drug groups and were accompanied by educational newsletters. The control group received no information on their prescribing. MAIN OUTCOME MEASURES: Prescribing rates in the intervention and control groups for the five main drug groups, total prescribing and potential substitute prescribing and ordering before and after the interventions. RESULTS: The intervention and control groups had similar baseline characteristics (age, sex, patient mix, practices). Median prescribing rates for the two groups were almost identical before and after the interventions. Any changes in prescribing observed in the intervention group were also seen in the control group. There was no evidence that feedback reduced the variability in prescribing nor did it differentially affect the very high or very low prescribers. CONCLUSIONS: The form of feedback evaluated here-mailed, unsolicited, centralised, government sponsored, and based on aggregate data-had no impact on the prescribing levels of general practitioners.

Adult↗

PubMed2000

Evaluation of the effectiveness of an educational intervention for general practitioners in adolescent health care: randomised controlled trial.

OBJECTIVE: To evaluate the effectiveness of an educational intervention in adolescent health designed for general practitioners in accordance with evidence based practice in continuing medical education. DESIGN: Randomised controlled trial with baseline testing and follow up at seven and 13 months. SETTING: Local communities in metropolitan Melbourne, Australia. PARTICIPANTS: 108 self selected general practitioners. INTERVENTION: A multifaceted educational programme for 2.5 hours a week over six weeks on the principles of adolescent health care followed six weeks later by a two hour session of case discussion and debriefing. OUTCOME MEASURES: Objective ratings of consultations with standardised adolescent patients recorded on videotape. Questionnaires completed by the general practitioners were used to measure their knowledge, skill, and self perceived competency, satisfaction with the programme, and self reported change in practice. RESULTS: 103 of 108 (95%) doctors completed all phases of the intervention and evaluation protocol. The intervention group showed significantly greater improvements in all outcomes than the control group at the seven month follow up except for the rapport and satisfaction rating by the standardised patients. 104 (96%) participants found the programme appropriate and relevant. At the 13 month follow up most improvements were sustained, the confidentiality rating by the standardised patients decreased slightly, and the objective assessment of competence further improved. 106 (98%) participants reported a change in practice attributable to the intervention. CONCLUSIONS: General practitioners were willing to complete continuing medical education in adolescent health care and its evaluation. The design of the intervention using evidence based educational strategies proved an effective and quick way to achieve sustainable and large improvements in knowledge, skill, and self perceived competency.

Adolescent↗

PubMed2002

Multicentre aneurysm screening study (MASS): cost effectiveness analysis of screening for abdominal aortic aneurysms based on four year results from randomised controlled trial.

OBJECTIVE: To assess the cost effectiveness of ultrasound screening for abdominal aortic aneurysms. DESIGN: Primary analysis: four year cost effectiveness analysis based directly on results from a randomised controlled trial in which patients were individually allocated to invitation to ultrasound screening (intervention) or to a control group not offered screening. Secondary analysis: projection of the data, based on conservative assumptions, to indicate likely cost effectiveness at 10 years. SETTING: Four centres in the United Kingdom. Screening delivered in primary care settings with follow up and surgery offered in the main hospitals Participants: Population based sample of 67 800 men aged 65-74 years. MAIN OUTCOME MEASURES: Mortality from and costs (screening, follow up, elective and emergency surgery) related to abdominal aortic aneurysm; cost per life year gained. RESULTS: Over four years there were 47 fewer deaths related to abdominal aortic aneurysms in the screening group than in the control group, but the additional costs incurred were pound 2.2m. After adjustment for censoring and discounted at 6% the mean additional cost of the screening programme was pound 63.39 ($97.77, euro;100.48) (95% confidence interval pound 53.31 to pound 73.48) per patient. The hazard ratio for abdominal aortic aneurysm was 0.58 (0.42 to 0.78). Over four years the mean incremental cost effectiveness ratio for screening was pound 28 400 ( pound 15 000 to pound 146 000) per life year gained, equivalent to about pound 36 000 per quality adjusted life year. After 10 years this figure is estimated to fall to around pound 8000 per life year gained. CONCLUSIONS: Even at four years the cost effectiveness of screening for abdominal aortic aneurysms is at the margin of acceptability according to current NHS thresholds. Over a longer period the cost effectiveness will improve substantially, the predicted ratio at 10 years falling to around a quarter of the four year figure.

Aged↗

PubMed2005

Effect of a multifaceted intervention on number of antimicrobial prescriptions for suspected urinary tract infections in residents of nursing homes: cluster randomised controlled trial.

OBJECTIVE: To assess whether a multifaceted intervention can reduce the number of prescriptions for antimicrobials for suspected urinary tract infections in residents of nursing homes. DESIGN: Cluster randomised controlled trial. SETTING: 24 nursing homes in Ontario, Canada, and Idaho, United States. PARTICIPANTS: 12 nursing homes allocated to a multifaceted intervention and 12 allocated to usual care. Outcomes were measured in 4217 residents. INTERVENTIONS: Diagnostic and treatment algorithm for urinary tract infections implemented at the nursing home level using a multifaceted approach--small group interactive sessions for nurses, videotapes, written material, outreach visits, and one on one interviews with physicians. MAIN OUTCOME MEASURES: Number of antimicrobials prescribed for suspected urinary tract infections, total use of antimicrobials, admissions to hospital, and deaths. RESULTS: Fewer courses of antimicrobials for suspected urinary tract infections per 1000 resident days were prescribed in the intervention nursing homes than in the usual care homes (1.17 v 1.59 courses; weighted mean difference -0.49, 95% confidence intervals -0.93 to -0.06). Antimicrobials for suspected urinary tract infection represented 28.4% of all courses of drugs prescribed in the intervention nursing homes compared with 38.6% prescribed in the usual care homes (weighted mean difference -9.6%, -16.9% to -2.4%). The difference in total antimicrobial use per 1000 resident days between intervention and usual care groups was not significantly different (3.52 v 3.93; weighted mean difference -0.37, -1.17 to 0.44). No significant difference was found in admissions to hospital or mortality between the study arms. CONCLUSION: A multifaceted intervention using algorithms can reduce the number of antimicrobial prescriptions for suspected urinary tract infections in residents of nursing homes.

Aged↗

PubMed2006

Oral protein energy supplements for children with cystic fibrosis: CALICO multicentre randomised controlled trial.

OBJECTIVE: To determine whether oral protein energy supplements, used long term in children with cystic fibrosis who are moderately malnourished, improve nutritional and other outcomes. DESIGN: Multicentre randomised controlled trial. SETTING: Seven specialist paediatric cystic fibrosis centres and their associated shared care clinics and seven smaller paediatric cystic fibrosis clinics. PARTICIPANTS: 102 children with cystic fibrosis, aged between 2 and 15 years, who were moderately malnourished. INTERVENTIONS: Oral protein energy supplements in addition to usual dietary advice compared with dietary advice alone, for 12 months. MAIN OUTCOME MEASURE: Change in body mass index centile over one year. RESULTS: Use of supplements was not associated with a change in body mass index centile (mean difference 2.99 centile points, 95% confidence interval -2.70 to 8.68) or other nutritional and spirometric outcomes in this group of children. CONCLUSIONS: Long term use of oral protein energy supplements did not result in an improvement in nutritional status or other clinical outcomes in children with cystic fibrosis who were moderately malnourished. Oral protein energy supplements should not be regarded as an essential part of the management of this group of children. TRIAL REGISTRATION: ISRCTN: 95744468.

Administration, Oral↗

PubMed2005

Limited benefits of ambulance telemetry in delivering early thrombolysis: a randomised controlled trial.

OBJECTIVES: To evaluate the potential of a continuous telemetry system linking rural ambulances to a coronary care unit to reduce call to thrombolysis times. METHODS: This prospective randomised controlled trial recruited patients using the 999 ambulance service in a rural area of the UK with signs or symptoms of coronary heart disease. Subjects were assigned to receive either standard paramedic treatment or transmission of 12 lead ECG, blood pressure, pulse oximetry, and relevant medical history to a general hospital coronary care unit. Cardiology senior house officers then determined each patient's suitability for pre-hospital thrombolysis time, and transmitted this decision back to the ambulance. This was documented as the potential thrombolysis, although no thrombolytic agents were administered by paramedics. The between groups difference in time to potential thrombolysis (intervention group) and actual thrombolysis (controls) was compared. The proportion of intervention group subjects ultimately receiving thrombolysis in hospital was compared with that recommended for pre-hospital thrombolysis. RESULTS: The potential reduction in call to treatment time for telemetry patients recommended for pre-hospital thrombolysis was 55 minutes (p = 0.022). Following hospital admission,21/213 of the telemetry patients were thrombolysed (10%, 95% confidence interval (CI) 6% to 15%). Of these patients, 3/21 received a recommendation for thrombolysis in the ambulance (14%, 95% CI 3.1% to 36.3%). The sensitivity and specificity of the telemetry system in detecting patients requiring thrombolysis was 13.6 and 99.5% respectively. Errors were made in the pre-hospital treatment recommendations for two patients. CONCLUSIONS: Continuous telemetry systems may significantly reduce call to treatment times for patients recommended for pre-hospital thrombolysis in a rural setting. However, this benefit must be balanced against the very small proportion of eligible patients identified as suitable for pre-hospital thrombolysis. This limitation may be due to communications problems, the criteria used to identify eligible patients, or the seniority of physicians tasked with making treatment decisions.

Aged↗

PubMed1998

Application of the MRC brain tumour prognostic index to patients with malignant glioma not managed in randomised control trial.

OBJECTIVES: The MRC brain tumour prognostic index, which uses clinical variables to place patients in different outcome categories, has not been evaluated on a cohort outside a randomised controlled trial. The aims of this study were to (a) determine in a large cohort of patients, derived solely from one centre and not in a clinical trial, whether the MRC prognostic index stratified patients for outcome; (b) compare actual outcomes with those obtained in the original studies; and (c) examine whether neuropathological diagnosis was an independent prognostic variable. METHODS: The MRC prognostic index was calculated for 236 patients with either glioblastoma or anaplastic astrocytoma managed at a dedicated neuro-oncology clinic in Edinburgh between 1989 and 1995. RESULTS: For this mixed population of malignant glioma the median survival was 8.6 months. Two year survival was 72.2% for patients with an MRC index score of 1-10; 36.3% for those with an index score of 11-15; 25.1% for those scoring 16-20; 20.4% with those scoring 21-25; 4.8% with those scoring 26-33; and 0% for those scoring 34-38. Exclusion of 79 patients who would not have been eligible for the MRC studies from which the index was derived, because they were either too old or did not receive radiotherapy, still resulted in a similar pattern of stratification but with significantly improved median survival times for the lowest two categories. Multivariate analysis of prognostic variables in the Edinburgh cohort showed that patients with anaplastic astrocytoma did significantly better than those with glioblastoma (p<0.001). CONCLUSIONS: Although there were some differences in median survival times between the patients in the original MRC studies and the Edinburgh cohort in similar prognostic categories and a tendency to improved two year survivorship in the Edinburgh cohort these differences have arisen because (a) the Edinburgh cohort was accrued about 10 years later than the study has shown that even outside the setting of a prospective controlled trial and with relaxed inclusion criteria the Medical Research Council (MRC) prognostic index is a robust predictor of outcome in patients with malignant glioma. Survival clearly declines as the prognostic index increases. Moreover, the prognostic model can be substantially improved by the addition of histology data, although there is some evidence that this will require complex modelling procedures.

Adult↗