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Results for “Randomised Controlled Trial”

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PubMed1998

Effectiveness of screening older people for impaired vision in community setting: systematic review of evidence from randomised controlled trials.

OBJECTIVE: To assess whether population screening for impaired vision among older people in the community leads to improvements in vision. DESIGN: Systematic review of randomised controlled trials of population screening in the community that included any assessment of vision or visual function with at least 6 months' follow up. SUBJECTS: Adults aged 65 or over. MAIN OUTCOME MEASURE: Proportions with visual impairment in intervention and control groups with any method of assessing visual impairment. RESULTS: There were no trials that primarily assessed visual screening. Outcome data on vision were available for 3494 people in five trials of multiphasic assessment. All the trials used self reported measures for vision impairment, both as screening tools and as outcome measures. The inclusion of a visual screening component in the assessment did not result in improvements in self reported visual problems (pooled odds ratio 1.04:95% confidence interval 0.89 to 1.22). A small reduction (11%) in the number of older people with self reported visual problems cannot be excluded. CONCLUSIONS: Screening of asymptomatic older people in the community is not justified on present evidence. Visual impairment in this age group can usually be reduced with treatment. It is unclear why no benefit was seen. Further work is needed to clarify what interventions are appropriate for older people with unreported impairment of vision.

Aged↗

PubMed1998

Effectiveness of antibiotic prophylaxis in critically ill adult patients: systematic review of randomised controlled trials.

OBJECTIVE: To determine whether antibiotic prophylaxis reduces respiratory tract infections and overall mortality in unselected critically ill adult patients. DESIGN: Meta-analysis of randomised controlled trials from 1984 and 1996 that compared different forms of antibiotic prophylaxis used to reduce respiratory tract infections and mortality with aggregate data and, in a subset of trials, data from individual patients. SUBJECTS: Unselected critically ill adult patients; 5727 patients for aggregate data meta-analysis, 4343 for confirmatory meta-analysis with data from individual patients. MAIN OUTCOME MEASURES: Respiratory tract infections and total mortality. RESULTS: Two categories of eligible trials were defined: topical plus systemic antibiotics versus no treatment and topical preparation with or without a systemic antibiotic versus a systemic agent or placebo. Estimates from aggregate data meta-analysis of 16 trials (3361 patients) that tested combined treatment indicated a strong significant reduction in infection (odds ratio 0.35; 95% confidence interval 0.29 to 0.41) and total mortality (0.80; 0.69 to 0.93). With this treatment five and 23 patients would need to be treated to prevent one infection and one death, respectively. Similar analysis of 17 trials (2366 patients) that tested only topical antibiotics indicated a clear reduction in infection (0.56; 0.46 to 0.68) without a significant effect on total mortality (1.01; 0.84 to 1.22). Analysis of data from individual patients yielded similar results. No significant differences in treatment effect by major subgroups of patients emerged from the analyses. CONCLUSIONS: This meta-analysis of 15 years of clinical research suggests that antibiotic prophylaxis with a combination of topical and systemic drugs can reduce respiratory tract infections and overall mortality in critically ill patients. This effect is significant and worth while, and it should be considered when practice guidelines are defined.

Administration, Topical↗

PubMed1989

Randomised controlled trial of interferon alfa 2A (rbe) (Roferon-A) for the treatment of chronic hepatitis B virus (HBV) infection: factors that influence response.

In a randomised controlled trial recombinant interferon alpha 2A (Roferon-A, rIFN alfa A) given at a dosage of 10 million units (MU)/m2 thrice weekly for six months was significantly better (p less than 0.02) than no treatment in producing a sustained loss of hepatitis Be antigen (HBeAg) in hepatitis B virus (HBV) chronic carriers. Although lower doses (5 MU/m2 and 2.5 MU/m2) also produced some responses, the seroconversion rate was not significantly greater than that observed in the control group. Sixteen of the 45 patients receiving interferon were human immunodeficiency virus (HIV) antibody positive: none of these responded. Forty one per cent of the anti-HIV negative patients receiving interferon (12/29, p less than 0.005) lost HBeAg and 17% (5/29) lost hepatitis B surface antigen (HBsAg). The response rate among these anti-HIV negative patients receiving at least three months therapy was 46% and 19% respectively. Low pretreatment HBV-DNA and absence of anti-HIV were the only significant independent variables predicting response to therapy (p less than 0.03 and p less than 0.05 respectively). In six patients, neutralising antibodies to alpha interferon were detected during therapy, the majority being non-responders.

Adult↗

PubMed1992

Antenatal care of low risk obstetric patients by midwives. A randomised controlled trial.

OBJECTIVES: To assess the practicality, acceptability to patients and salary costs of the antenatal care of low risk obstetric patients by midwives. DESIGN: A randomised controlled trial. SETTING: The antenatal clinic at Westmead Hospital, a teaching hospital of the University of Sydney in western Sydney. PATIENTS: From January 1989 until November 1990, 89 women booking for full antenatal care at Westmead Hospital and classified as low risk were randomly allocated to one of two groups. Group 1 (43 patients) had their antenatal care provided by registered midwives. Group 2 (46 patients) had their antenatal care provided by an obstetrician (either Visiting Medical Officer or Staff Specialist) in a routine hospital antenatal clinic. INTERVENTIONS: Patients in the midwives' clinic were seen by an obstetrician at their first visit to the antenatal clinic and again at 30 weeks and at 40 weeks. MAIN OUTCOME MEASURES: These were the salary costs of each clinic and the patients' levels of satisfaction. Maternal and neonatal indicators, delivery details and analgesic requirements were also considered. These indicators were planned before data collection commenced. RESULTS: The major differences found were a 28% to 68% salary cost saving and that patients cared for by midwives showed appreciation of the continuity of care and information given at the midwives' clinic. CONCLUSIONS: The care of low risk obstetric patients by midwives in a midwives' clinic showed salary cost savings and high patient acceptance.

Continuity of Patient Care↗

PubMed1997

Satisfaction and the three C's: continuity, choice and control. Women's views from a randomised controlled trial of midwife-led care.

OBJECTIVE: 1. To explore whether there are differences in women's satisfaction with care in a midwife-managed delivery unit compared with that in a consultant-led labour ward. 2. To compare factors relating to continuity, choice and control between the two randomised groups. DESIGN: A pragmatic randomised controlled trial. SETTING: Aberdeen Maternity Hospital, Grampian. SAMPLE: 2844 women, identified at booking as low risk, were randomised in a 2:1 ratio between the midwives' unit and the labour ward. MAIN OUTCOME MEASURES: Satisfaction, continuity of carer, choice, and control. RESULTS: Satisfaction with the overall experience did not differ between the groups. Satisfaction with how labour and delivery was managed by staff was slightly higher in the midwives' unit group, but this did not reach the 0.1% level of significance. Women allocated to the midwives' unit group saw significantly fewer medical staff and were less likely to report numerous individuals entering the room. They were more likely to report having had a choice regarding mobility and alternative positions for delivery and were significantly more likely to have made their own decisions regarding pain relief. CONCLUSIONS: The issues surrounding the measurement of satisfaction with childbirth need further investigation. Until this area is clarified it would be unwise to use an overall measure of satisfaction as an indicator of the quality of maternity service provision. In particular, the current measures are not sensitive enough to examine the specific factors which affect women's satisfaction. Further research is required to assess which factors are important to women if they are to have a positive experience of childbirth and how these priorities change over time.

Adult↗

PubMed1995

UKCCCR multicentre randomised controlled trial of one and two view mammography in breast cancer screening.

OBJECTIVE: To compare one view (oblique) and two view (oblique and craniocaudal) mammography in breast cancer screening. DESIGN: Randomised controlled trial. SETTING: Nine breast screening centres in England. SUBJECTS: 40,163 women aged 50-64 attending their first breast screening examination. INTERVENTIONS: Women were randomised to have one view mammography, two view mammography, or two view mammography in which one view was read by one reader and both views were read by another. MAIN OUTCOME MEASURES: Prevalence of cancer detected, recall rates, cost per cancer detected, and marginal cost per extra cancer detected. RESULTS: Two view mammography detected 24% more women with breast cancer (95% confidence interval 16% to 31%) than one view mammography. Prevalence of detected cancer was 6.84 with two view mammography and 5.52 per 1000 women with one view. The proportion of women recalled for assessment was 15% lower (95% confidence interval 6% to 23%) with two view (6.97%) than with one view (8.16%) mammography. The cost of two view screening was higher (26.46 pounds compared with 22.00 pounds per examination) but the average cost per cancer detected was similar (5330 pounds compared with 5310 pounds) and the marginal cost per extra cancer detected with two views was similar to the average cost (5400 pounds). CONCLUSION: Two view mammography is medically more effective than one view; it detects more cancers and reduces recall rates; it is also similarly cost effective financially.

Breast Neoplasms↗

PubMed1997

Randomised controlled trial of inhaled corticosteroids (fluticasone propionate) in cystic fibrosis.

BACKGROUND: Controlling lung inflammation may be the key to improving morbidity and mortality in cystic fibrosis. OBJECTIVE: To assess the effects of inhaled corticosteroids on lung inflammation in cystic fibrosis. DESIGN: Double blind placebo controlled randomised sequence crossover trial. Fluticasone propionate (400 micrograms/day) was given as a dry powder inhaler for six weeks with a four week washout period before crossover. OUTCOME MEASURES: Sputum inflammatory markers (interleukin-8, tumour necrosis factor-alpha (TNF-alpha) and neutrophil elastase-both free and bound to alpha 1-antiprotease), sputum interleukin-10, lung function, and symptomatology. SUBJECTS: Twenty three children from a regional cystic fibrosis centre were enrolled into the study, with mean age 10.3 years (range 7 to 17 years) and mean baseline forced expiratory volume in one second (FEV1) of 64% (range 21% to 102%) predicted for sex and height. One patient was excluded for non-compliance to the study protocol. RESULTS: No significant benefit was shown for the use of fluticasone propionate in any of the outcomes. For sputum interleukin-8 there was an estimated true treatment median difference of 142 pg/ml (95% confidence interval (CI) 8 to 2866 pg/ml) in favour of placebo; while for maximal expiratory flow at 25% (MEF25%) remaining forced vital capacity predicted for sex and height there was a 15 percentage points (pp) (95% CI 4 to 26 pp) mean treatment difference in favour of placebo. Sputum interleukin-10 was undetected in any samples and unaffected by fluticasone propionate. Neither atopic status, baseline FEV1, nor concomitant DNase therapy had any effect on response to treatment. CONCLUSIONS: Lack of benefit from fluticasone propionate was most likely due to failure of the drug to penetrate the viscid mucus lining the airways. It is suggested a large multicentre trial with higher doses given for a longer time by a different delivery system is required to assess efficacy.

Administration, Inhalation↗

PubMed1984

Randomised controlled trial of routine hospital clinic care versus routine general practice care for type II diabetics.

Two hundred patients with type II diabetes were entered into a randomised controlled trial lasting five years to compare routine care of this condition by a hospital diabetic clinic with routine care in general practice. Fewer patients in the group being cared for by their general practitioner (general practice group) were regularly reviewed or had regular estimations of blood glucose concentration. More patients in the general practice group than in the hospital group were admitted to hospital for medical reasons during the study (25 (24%) compared with 17 (18%] and more patients in the general practice group died (18) than did in the hospital group (6). At the end of the study mean concentrations of haemoglobin A1 were higher in the general practice group (10.4%) than in the hospital group (9.5%). Routine care in general practice for patients with type II diabetes was less satisfactory than care by the hospital diabetic clinic.

Adult↗

PubMed1997

Textured or smooth implants for breast augmentation? Three year follow-up of a prospective randomised controlled trial.

Silicone breast implant surface texturing has been shown to reduce the short-term incidence of adverse (Baker III/IV) capsular contracture in augmentation mammaplasty in double-blind randomised controlled trials. It is, however, undetermined whether the textured surface merely delays the onset of severe contracture or its effect on capsular contraction is persistent. The current study reviewed, after three years, 49 of the 53 patients who had undergone subglandular breast augmentation mammaplasty in a randomised double-blind study with textured or smooth silicone gel-filled implants in 1989. The incidence of adverse capsular contracture was 59% for smooth implants and 11% for textured ones (P = 0.001; chi 2 = 10.60). Eight patients (31%) with smooth prostheses underwent breast implant exchange for severe capsular contracture between the one and three year assessments, compared with a revisional surgery rate of only 7.4% (2/27 patients) for the textured group (P < 0.04). These adverse capsular contracture and revisional breast implant surgery rates clearly demonstrate that the effect of textured implants in reducing capsular contracture in augmentation mammaplasty found at one year is maintained at three years, and suggest that it may be long lasting.

Breast Implants↗

PubMed1994

No effect of birth centre care on either duration or experience of breast feeding, but more complications: findings from a randomised controlled trial.

OBJECTIVE: to study the effect of birth centre care on the duration of breast feeding, breast feeding complications, and women's experiences of breast feeding. DESIGN: randomised controlled trial. SETTING: in-hospital birth centre at South Hospital, Stockholm, and standard obstetric care in the Greater Stockholm area. SUBJECTS: 1230 women with expected date of birth between October 1989 and February 1992, interested in participating in a birth centre trial, and meeting medical low-risk criteria. 617 women were allocated to the experimental group offered birth centre care (EG), and 613 to the control group offered standard obstetric care (CG). MAIN OUTCOME MEASURES: duration of breast feeding, breast feeding complications such as sore nipples, engorgement, milk stasis, and mastitis, and women's experiences of breast feeding. FINDINGS: no difference was found between EG and CG in the duration of breast feeding. Ninety-three per cent in both groups were breast feeding exclusively two months post partum. The average number of months of breast feeding, exclusively or partly, when investigated one year after the birth was 8.6 in EG and 8.5 in CG. No difference was observed in women's experiences of breast feeding, but rather more women in EG than in CG reported sore nipples, 36% and 30% respectively (p = 0.03), and milk stasis, 26% and 19% respectively (p = 0.002). CONCLUSIONS: birth centre care had no effect on the duration of breast feeding, or on women's experiences of breast feeding. Prenatal attitudes were probably more significant predictors of these outcomes than differences in the two modes of maternity care in this population of highly breast feeding-motivated women. The larger proportion of sore nipples and milk stasis in the EG might have been due to earlier discharge, or to midwives less skilled in assisting with breast feeding at the birth centre than in the postpartum wards.

Adult↗

PubMed1998

Cost effectiveness of community leg ulcer clinics: randomised controlled trial.

OBJECTIVES: To establish the relative cost effectiveness of community leg ulcer clinics that use four layer compression bandaging versus usual care provided by district nurses. DESIGN: Randomised controlled trial with 1 year of follow up. SETTING: Eight community based research clinics in four trusts in Trent. SUBJECTS: 233 patients with venous leg ulcers allocated at random to intervention (120) or control (113) group. INTERVENTIONS: Weekly treatment with four layer bandaging in a leg ulcer clinic (clinic group) or usual care at home by the district nursing service (control group). MAIN OUTCOME MEASURES: Time to complete ulcer healing, patient health status, and recurrence of ulcers. Satisfaction with care, use of services, and personal costs were also monitored. RESULTS: The ulcers of patients in the clinic group tended to heal sooner than those in the control group over the whole 12 month follow up (log rank P=0.03). At 12 weeks, 34% of patients in the clinic group were healed compared with 24% in the control. The crude initial healing rate of ulcers in intervention compared with control patients was 1.45 (95% confidence interval 1.04 to 2. 03). No significant differences were found between the groups in health status. Mean total NHS costs were 878.06 pounds per year for the clinic group and 859.34 pounds for the control (P=0.89). CONCLUSIONS: Community based leg ulcer clinics with trained nurses using four layer bandaging is more effective than traditional home based treatment. This benefit is achieved at a small additional cost and could be delivered at reduced cost if certain service configurations were used.

Aged↗

PubMedDate not supplied

Pneumatic retinopexy versus scleral buckling: a randomised controlled trial.

Pneumatic retinopexy (PR) is a technique for repairing certain retinal detachments which is easier to perform than conventional sceral buckling (SB) surgery but has comparable results. We performed a prospective, randomised, controlled trial to determine for ourselves whether PR is a safe and acceptable procedure. Twenty patients presenting consecutively with retinal detachments which fulfilled the selection criteria were randomised to have their detachments repaired by either PR or SB, ten patients in each group. The suitable patients had a single retinal break or small group of breaks of not greater than one clock hour in size, situated within the superior eight clock hours of retina. Patients with significant proliferative vitreoretinopathy or other fundus disorders were excluded. All patients in the PR group had local anaesthesia while all those in the SB group had general anaesthesia. Successful reattachment of the retina was achieved with one or more procedures in 90 percent of the PR group and in 100 percent of the SB group. We feel that narrowing the selection criteria for PR may further improve the success rate.

Cryosurgery↗

PubMed1996

Variation in the placebo effect in randomised controlled trials of analgesics: all is as blind as it seems.

The objective was to investigate the relationship between pain relief scores produced by placebo and by active interventions in randomised controlled trials (RCTs). Individual patient categorical pain relief scores from 5 placebo-controlled single-dose parallel-group RCTs in acute postoperative pain were used to calculate the percentage of the maximum possible pain relief score (%maxTOTPAR) for the different treatments. One hundred and thirty of the 525 patients in the 5 trials had a placebo. Individual patients' scores with placebo varied from 0 to 100% of the maximum possible pain relief. The proportion who obtained more than 50% of the maximum possible pain relief with placebo varied from 7% to 37% across the trials; with the active drugs the variation was from 5 to 63%. Mean placebo scores were related to the mean score for the active treatments in each study; the higher the mean active score, the higher the mean placebo score. This relationship disappeared when median values were used. Medical folklore has it that the amount of relief obtained with placebo is one-third of the maximum possible (and does not vary), and that one-third of patients respond to placebo. The results show that the amount of relief obtained with placebo varies considerably between patients, that 38% of patients obtained more than 10% of the maximum possible relief, and 16% obtained greater than 50%. In double-blind, randomised parallel-group studies of high quality placebo scores should not vary. Despite these conditions being met the placebo scores did vary. The previous explanation, of a relationship between the mean placebo scores and the mean scores for the active treatments was not supported.

Analgesics↗

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↗

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↗

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↗