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Results for “randomised trial”

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PubMed1997

Randomised trials of STD treatment for HIV prevention: report of an international workshop. HIV/STD Trials Workshop Group.

Three community trials of the impact of STD treatment interventions on HIV incidence in rural populations have been completed or are in progress in Uganda and Tanzania. Investigators from these trials met for a joint technical workshop in Baltimore in May 1996. This report summarises the consensus of the workshop, with the aim of providing useful input to research on HIV intervention strategies. Issues discussed include: (i) the role of community randomised trials; (ii) strategies for STD management; (iii) epidemiological and statistical issues in the design and analysis of community randomised trials; (iv) diagnostic methods for STDs in population surveys; (v) treatment regimens for STDs in rural Africa; and (vi) ethical issues in community trials.

Community Health Services↗

PubMed2005

Prevalence of opioid adverse events in chronic non-malignant pain: systematic review of randomised trials of oral opioids.

Adverse events of opioids may restrict their use in non-cancer pain. Analysis of the incidence of common adverse events in trials conducted in non-cancer pain has usually been limited to opioids used to treat severe pain according to the WHO three-step ladder. To examine the incidence of common adverse events of opioids in non-cancer pain, a systematic review and meta-analysis of information from randomised trials of all opioids in non-cancer pain was undertaken. Studies used were published randomised trials of oral opioid in non-cancer pain, with placebo or active comparator. Thirty-four trials with 5,546 patients were included with 4,212 patients contributing some information on opioid adverse events. Most opioids used (accounting for 90% of patients) were for treating moderate rather than severe pain. Including trials without a placebo increased the amount of information available by 1.4 times. Because of clinical heterogeneity in condition, opioid, opioid dose, duration, and use of titration, only broad results could be calculated. Use of any oral opioid produced higher rates of adverse events than did placebo. Dry mouth (affecting 25% of patients), nausea (21%), and constipation (15%) were the most common adverse events. A substantial proportion of patients on opioids (22%) withdrew because of adverse events. Because most trials were short, less than four weeks, and because few titrated the dose, these results have limited applicability to longer-term use of opioids in clinical practice. Suggestions for improved studies are made.

Administration, Oral↗

PubMed2005

The MEMA kwa Vijana project: design of a community randomised trial of an innovative adolescent sexual health intervention in rural Tanzania.

BACKGROUND: Effective interventions to reduce the incidence of HIV, other sexually transmitted infections (STIs) and unwanted pregnancy among adolescents in sub-Saharan Africa are urgently needed. This paper describes the rationale and design of a randomised trial of the impact of an innovative sexual health intervention among adolescents in rural Mwanza Region, Tanzania. METHODS: The MEMA kwa Vijana intervention comprises a teacher-led, peer-assisted sexual health education programme for students in the last 3 years of primary school, training and supervision of health workers in the provision of youth-friendly health services, peer condom promotion and distribution, and wider community activities. Detailed process evaluation was conducted and the impact of the intervention was evaluated through a community-randomised trial in which a cohort of 9645 adolescents was followed up for 3 years. Both process and impact evaluation used multiple assessment methods. Impact measures included incidence and prevalence of HIV and other STIs, pregnancy rates, knowledge and reported attitudes and sexual behaviour, as well as qualitative assessments. RESULTS: Results of the baseline survey of the cohort have been presented previously. The outcome of the trial will be reported separately. CONCLUSIONS: Behaviour change interventions among adolescents have been widely advocated, but there have been few rigorously designed trials of their effectiveness, particularly in developing countries, and measurement of sexual behaviour is particularly problematic in this age group. The MEMA kwa Vijana trial was undertaken to address these problems and to collect rigorous evidence on the effectiveness of an innovative intervention, designed to be implemented on a very large scale.

Adolescent↗

PubMed2006

Measuring improved targeting of health interventions to the poor in the context of a community-randomised trial in rural India.

In spite of growing interest in socioeconomic differentials in health outcomes and access to health services, little has been written about methodologies for assessing the impact of equity-enhancing policies or programs. This paper describes three methodological challenges involved in designing a randomised trial with an equity outcome, and how these were met in a trial of alternative strategies to improving the uptake of benefits of a health insurance scheme among its poorest members. The Vimo SEWA trial is nested within a community-based insurance scheme in rural India. While conducting this trial, three methodological problems were encountered: (i) measuring poverty (or "wealth", or "socioeconomic status") (ii) assessing beneficiaries against an appropriate reference standard population and (iii) settling on an appropriate equity measure as an outcome indicator. These problems are likely to arise in any policy or program assessment that has an equity outcome. In the Vimo SEWA trial, the socioeconomic status of beneficiaries (claimants) is assessed relative to that of all scheme members living in same sub-district by applying a rapid assessment questionnaire--which reduces to an integrated index of socioeconomic status--to both a random sample of members in each sub-district, and to all claimants. The results are used to estimate the full distribution of socioeconomic status of members in each sub-district, with each member given a rank score between 0 and 100. Interpolation is used to estimate the rank scores of claimants relative to the membership base. The primary outcome measure for the trial is the mean socioeconomic rank score of claimants. In developing country settings, using an index of socioeconomic status is simpler than assessing household income or the value of household consumption. It is also relatively straightforward to compare the socioeconomic status of health program beneficiaries with a relevant reference population, although two independent surveys are required. Expressing relative wealth on a scale from zero to 100 is conceptually appealing, and the mean value of this rank score provides an equity-specific outcome measure readily integrated into the usual analytic framework for cluster-randomised trials.

Developing Countries↗

PubMed2005

A randomised trial of high-dose chemotherapy in the salvage treatment of patients failing first-line platinum chemotherapy for advanced germ cell tumours.

BACKGROUND: Incomplete remission or relapse from first-line chemotherapy has poor prognosis in male germ cell tumour patients. This phase III randomised trial compares conventional salvage to high-dose-intensification chemotherapy. PATIENTS AND METHODS: Between February 1994 and September 2001, 280 patients from 43 institutions in 11 countries, were randomly assigned to receive either four cycles of cisplatin, ifosfamide and etoposide (or vinblastine) (arm A), or three such cycles followed by high-dose carboplatin, etoposide and cyclophosphamide (CarboPEC) with haematopoietic stem cell support (arm B). RESULTS: Similar complete and partial response rates were observed in both treatment arms (56%; 95% CI 50% to 62%). There were 3% and 7% toxic deaths in arms A and B, respectively. No significant improvements with CarboPEC were observed in either 3-year event-free survival (35% versus 42%, P=0.16) or overall survival (53%; 95% CI 46% to 59%). Complete responders with CarboPEC had a significant improvement in disease-free survival (55% versus 75% at 3 years, P <0.04). CONCLUSIONS: The single cycle of high-dose salvage chemotherapy after three cycles of standard dose chemotherapy had no effect on treatment outcomes. These results suggest that data from uncontrolled studies should not be used to justify routine use of a toxic and expensive treatment without confirmation in a randomised trial.

Adolescent↗

PubMed2000

Use of lipid lowering drugs for primary prevention of coronary heart disease: meta-analysis of randomised trials.

OBJECTIVE: To summarise the effect of primary prevention with lipid lowering drugs on coronary heart disease events, coronary heart disease mortality, and all cause mortality. DESIGN: Meta-analysis. IDENTIFICATION: Systematic search of the Medline database from January 1994 to June 1999 for English language studies examining drug treatment for lipid disorders (use of the MeSH terms "hyperlipidemia" and "anticholesteremic agents," keyword searches for individual drug names, and a search strategy for identifying randomised trials to capture relevant articles); identification of older studies through systematic reviews and hand search of bibliographies. INCLUSION CRITERIA: All randomised trials of at least one year's duration that examined drug treatment for patients with no known coronary heart disease, cerebrovascular disease, or peripheral vascular disease and that measured clinical end points, including all cause mortality, coronary heart disease mortality, and non-fatal myocardial infarctions. DATA EXTRACTION: Review of the articles and extracted relevant data by two authors separately, with disagreements resolved by consensus. RESULTS: Four studies met eligibility criteria. Drug treatment reduced the odds of a coronary heart disease event by 30% (summary odds ratio 0.70, 95% confidence interval 0.62 to 0.79) but not the odds of all cause mortality (0.94, 0.81 to 1.09). When statin drugs were considered alone, no substantial differences in results were found. CONCLUSIONS: Treatment with lipid lowering drugs lasting five to seven years reduces coronary heart disease events but not all cause mortality in people with no known cardiovascular disease.

Cause of Death↗

PubMed2003

Neoadjuvant chemotherapy for locally advanced cervical cancer: a systematic review and meta-analysis of individual patient data from 21 randomised trials.

Despite the enrollment of more than 3000 women in randomised trials, the benefits and risks of neoadjuvant chemotherapy in the treatment of locally advanced cervical cancer remain uncertain. We carried out a systematic review and meta-analysis of individual patient data to assess the effect of neoadjuvant chemotherapy in two comparisons. In the first comparison, of neoadjuvant chemotherapy followed by radical radiotherapy compared with the same radiotherapy alone, we obtained data from 18 trials and 2074 patients. When all trials were considered together, a high level of statistical heterogeneity suggested that the results could not be combined indiscriminately. A substantial amount of heterogeneity was explained by separate analyses of groups of trials. Trials using chemotherapy cycle lengths of 14 days and shorter (Hazard Ratio (HR))=0.83, 95% Confidence Interval (CI)=0.69-1.00, P=0.046) or cisplatin dose intensities greater than or equal to 25 mg/m2 per week (HR=0.91, 95% CI=0.78-1.05, P=0.20) tended to show an advantage for neoadjuvant chemotherapy on survival. In contrast, trials using cycle lengths longer than 14 days (HR=1.25, 95% CI=1.07-1.46, P=0.005) or cisplatin dose intensities lower than 25mg/m2 per week (HR=1.35, 95% CI=1.11-1.14, P=0.002) tended to show a detrimental effect of neoadjuvant chemotherapy on survival. In the second comparison, of neoadjuvant chemotherapy followed by surgery compared with radical radiotherapy alone, data from 5 trials and 872 patients were obtained. The combined results from all trials (HR=0.65, 95% CI=0.53-0.80, P=0.0004) indicated a highly significant reduction in the risk of death with neoadjuvant chemotherapy, but there were some differences between the trials in their design and results. Despite some unexplained heterogeneity, the timing and dose intensity of cisplatin-based neoadjuvant chemotherapy appears to have an important impact on whether or not it benefits women with locally advanced cervical cancer and warrants further exploration.

Adult↗

PubMed2001

Extracapsular cataract extraction compared with small incision surgery by phacoemulsification: a randomised trial.

BACKGROUND: Cataract extraction constitutes the largest surgical workload in ophthalmic units throughout the world. Extracapsular cataract extraction (ECCE), through a large incision, with insertion of an intraocular lens has been the most widely used method from 1982 until recently. Technological advances have led to the increasing use of phacoemulsification (Phako) to emulsify and remove the lens The technique requires a smaller incision, but requires substantial capital investment in theatre equipment. In this randomised trial we assessed the clinical outcomes and carried out an economic evaluation of the two procedures. METHODS: In this two centre randomised trial, 232 patients with age related cataract received ECCE, and 244 received small incision surgery by Phako. The main comparative outcomes were visual acuity, refraction, and complication rates. Resource use was monitored in the two trial centres and in an independent comparator centre. Costs calculated included average cost per procedure, at each stage of follow up. RESULTS: Phako was found to be clinically superior. Surgical complications and capsule opacity within 1 year after surgery were significantly less frequent, and a higher proportion achieved an unaided visual acuity of 6/9 or better (<0.2 logMAR) in the Phako group. Postoperative astigmatism was more stable in Phako. The average cost of a cataract operation and postoperative care within the trial was similar for the two procedures. With the input of additional spectacles for corrected vision at 6 months after surgery, the average cost per procedure was pound359.89 for Phako and pound367.57 for ECCE. CONCLUSION: Phako is clinically superior to ECCE and is cost effective.

Aged↗

PubMed2001

Trial of invasive versus medical therapy in elderly patients with chronic symptomatic coronary-artery disease (TIME): a randomised trial.

BACKGROUND: Since previous randomised treatment trials in coronary disease have focused on patients younger than 75 years of age, their findings might not apply to the elderly population in whom the cardiac risk profile, risk of intervention, and comorbidities are increased. We aimed to assess quality of life and outcome of elderly patients with coronary disease after medical or revascularisation therapy. METHODS: In this randomised, prospective, multicentre trial, we enrolled patients aged 75 years or older with chronic angina of at least Canadian Cardiac Society class II despite at least two antianginal drugs. Patients were randomly assigned coronary angiography and revascularisation or optimised medical therapy. The primary endpoint was quality of life after 6 months, as assessed by questionnaire and the presence of major adverse cardiac events (death, non-fatal myocardial infarction, or hospital admission for acute coronary syndrome with or without the need for revascularisation). Analysis was by intention to treat. FINDINGS: 150 patients were assigned medical therapy and 155 invasive therapy. Two protocol violators in each group were not included in the analysis. After 6 months, angina severity decreased and measures of quality of life increased in both treatment groups; however, these improvements were significantly greater after revascularisation. Major adverse cardiac events occurred in 72 (49%) of patients in the medical group and 29 (19%) in the invasive group (p<0.0001). INTERPRETATION: Patients aged 75 years or older with angina despite standard drug therapy benefit more from revascularisation than from optimised medical therapy in terms of symptom relief and quality of life. Therefore, these patients should be offered invasive assessment despite their high risk profile followed by revascularisation if feasible.

Aged↗

PubMed1996

A randomised trial of fibrin sealant in peripheral vascular surgery.

In a prospective randomised trial 39 patients undergoing either arterial bypass surgery with a polytetrafluoroethylene (PTFE) bypass graft (n = 18) or aortic aneurysm repair with a woven Dacron graft (n = 21) were randomised either to receive fibrin sealant as a topical haemostatic agent at the arterial anastomosis or to act as control. The main outcome measure was the time taken to achieve haemostasis at the suture line. The median time to achieve haemostasis was 0.5 min (range 0-11 min) in the treatment group and 4 min (range 0-21 min) in the control group. This difference was statistically significant p < 0.014 by the Mann-Whitney test. Immediate haemostasis on release of the clamps was achieved in 13/21 patients in the treatment group and in 4/18 patients in the control group (p = 0.023 by Fisher's exact test). There was no difference in total operative time or operative blood loss. No patients in the treatment group suffered any perioperative thromboembolic event and 1 patient in the control group suffered an early graft occlusion. There was no evidence of transmission of hepatitis B or C, or parvovirus B19. In conclusion, fibrin sealant is an effective topical haemostatic agent for arterial suture lines involving PTFE or woven Dacron.

Aged↗

PubMed2004

How should randomised trials including multiple pregnancies be analysed?

OBJECTIVE: To compare the effects of four methods of analysis on the results of randomised controlled trials that recruit women with multiple pregnancies and measure outcomes on their babies. DESIGN: Analysis of one real and two simulated data sets. SETTING: Secondary analysis of perinatal randomised controlled trials. POPULATION: Randomised controlled trials including women with multiple pregnancies. METHODS: The analytical methods compared were (a) assuming independence among babies, (b) analysing outcomes per women, counting a woman as having an outcome if any of her babies had it (equivalent to selecting the worst outcome among any of a woman's babies), (c) randomly selecting one baby from each set of multiples for inclusion in the analysis, (d) adjustment of the analysis to take account of non-independence of babies from multiple pregnancies, using methods developed for analysis of cluster randomised trials. MAIN OUTCOME MEASURES: Odds ratios for trials' main outcomes. RESULTS: Results from application of cluster trial methods were similar to those from assuming independence among babies, but with slightly wider confidence intervals, reflecting the reduced effective sample size caused by non-independence between babies from the same pregnancy. Results were more variable using the other two methods, and in some cases, departed markedly from the results of the cluster trial methods. CONCLUSIONS: Cluster trial methods provide a simple way of adjusting the analysis to take account of non-independence between babies from the same pregnancy. Random selection and analysis by pregnancy (methods (b) and (c)) have disadvantages and do not report outcomes for all of the babies in the trial. This may cause problems with incorporating trials analysed using these methods into systematic reviews.

Cluster Analysis↗

PubMed2006

Cluster randomised trial of an active, multifaceted educational intervention based on the WHO Reproductive Health Library to improve obstetric practices.

OBJECTIVE: We conducted a trial to evaluate the effect of an active, multifaceted educational strategy to promote the use of the WHO Reproductive Health Library (RHL) on obstetric practices. DESIGN: Cluster randomised trial. The trial was assigned the International Standardised Randomised Controlled Trial Number ISRCTN14055385. SETTINGS: Twenty-two hospitals in Mexico City and 18 in the Northeast region of Thailand. METHODS: The intervention consisted primarily of three interactive workshops using RHL over a period of 6 months. The focus of the workshops was to provide access to knowledge and enable its use. A computer and support for using both the computer and RHL were provided at each hospital. The control hospitals did not receive any intervention. MAIN OUTCOME MEASURES: The main outcome measures were changes in ten selected clinical practices as recommended in RHL starting approximately four to six months after the third workshop. Clinical practice data were collected at each hospital from 1000 consecutively delivered women or for a 6-month period whichever was reached sooner. RESULTS: The active, multifaceted educational intervention we employed did not affect the ten targeted practices in a consistent and substantive way. Iron/folate supplementation, uterotonic use after birth and breastfeeding on demand were already frequently practiced, and we were unable to measure external cephalic version. Of the remaining six practices, selective, as opposed to routine episiotomy policy increased in the intervention group (difference in adjusted mean rate = 5.3%; 95% CI -0.1 to 10.7%) in Thailand, and there was a trend towards an increased use of antibiotics at caesarean section in Mexico (difference in adjusted mean rate = 19.0%; 95% CI: -8.0 to 46.0%). There were no differences in the use of labour companionship, magnesium sulphate use for eclampsia, corticosteroids for women delivering before 34 weeks and vacuum extraction. RHL awareness (24.8-65.5% in Mexico and 33.9-83.3% in Thailand) and use (4.8-34.9% in Mexico and 15.5-76.4% in Thailand) increased substantially after the intervention in both countries. CONCLUSION: The multifaceted, active strategy to provide health workers with the knowledge and skills to use RHL to improve their practice led to increased access to and use of RHL, however, no consistent or substantive changes in clinical practices were detected within 4-6 months after the third workshop.

Clinical Competence↗

PubMedDate not supplied

[Critical appraisal of systematic reviews of randomised trials in nephrology: theory and practice for interpreting level I evidence].

INTRODUCTION: Systematic reviews represent the primary level of evidence (level I evidence) and an excellent answer to causality questions. They should be based upon high quality standards and the critical appraisal of such study design is fundamental. METHODS: In this review we introduce the primary indicators of quality and guide our readers through the process of critical appraisal of systematic reviews. RESULTS: The main criteria in critically appraising systematic reviews in nephrology are the adequate presentation of a research question, adequate selection of studies, comprehensiveness of search strategies, the quality assessment of included studies, the fact that all procedures have been performed independently by at least 2 investigators, the exploration of heterogeneity, the type of results and their applicability. In nephrology we still lack a large number of systematic reviews because of the lack of randomised trials. CONCLUSIONS: Preparing a large number of systematic reviews is an important challenge for the nephrology community. This community should prepare more randomised trials to answer intervention questions and should make an effort to synthesise the evidence in the form of systematic reviews. It is essential that available systematic reviews be critically appraised and their results implemented in the clinical practice whenever they are based on high methodological standards.

Nephrology↗

PubMed2005

Does a pre-hospital emergency pathway improve early diagnosis and referral in suspected stroke patients?--Study protocol of a cluster randomised trial [ISRCTN41456865].

BACKGROUND: Early interventions proved to be able to improve prognosis in acute stroke patients. Prompt identification of symptoms, organised timely and efficient transportation towards appropriate facilities, become essential part of effective treatment. The implementation of an evidence based pre-hospital stroke care pathway may be a method for achieving the organizational standards required to grant appropriate care. We performed a systematic search for studies evaluating the effect of pre-hospital and emergency interventions for suspected stroke patients and we found that there seems to be only a few studies on the emergency field and none about implementation of clinical pathways. We will test the hypothesis that the adoption of emergency clinical pathway improves early diagnosis and referral in suspected stroke patients. We designed a cluster randomised controlled trial (C-RCT), the most powerful study design to assess the impact of complex interventions. The study was registered in the Current Controlled Trials Register: ISRCTN41456865--implementation of pre-hospital emergency pathway for stroke--a cluster randomised trial. METHODS/DESIGN: Two-arm cluster-randomised trial (C-RCT). 16 emergency services and 14 emergency rooms were randomised either to arm 1 (comprising a training module and administration of the guideline), or to arm 2 (no intervention, current practice). Arm 1 participants (152 physicians, 280 nurses, 50 drivers) attended an interactive two sessions course with continuous medical education CME credits on the contents of the clinical pathway. We estimated that around 750 patients will be met by the services in the 6 months of observation. This duration allows recruiting a sample of patients sufficient to observe a 30% improvement in the proportion of appropriate diagnoses. Data collection will be performed using current information systems. Process outcomes will be measured at the cluster level six months after the intervention. We will assess the guideline recommendations for emergency and pre-hospital stroke management relative to: 1) promptness of interventions for hyperacute ischaemic stroke; 2) promptness of interventions for hyperacute haemorrhagic stroke 3) appropriate diagnosis. Outcomes will be expressed as proportions of patients with a positive CT for ischaemic stroke and symptoms onset < or = 6 hour admitted to the stroke unit. DISCUSSION: The fields in which this trial will play are usually neglected by randomised controlled trial (RCT). We have chosen the cluster-randomised controlled trial (C-RCT) to address the issues of contamination, adherence to real practice, and community dimension of the intervention, with a complex definition of clusters and an extensive use of routine data to collect the outcomes.

Brain Ischemia↗

PubMed2004

Metastatic seminoma treated with either single agent carboplatin or cisplatin-based combination chemotherapy: a pooled analysis of two randomised trials.

To study the role of single agent carboplatin chemotherapy in patients with metastatic seminoma based on the data from two randomised trials. In subgroup analyses in patients with different disease characteristics, the outcome treated with either single agent carboplatin or cisplatin-based combination chemotherapy was compared. Individual patient data from two randomised European trials involving patients with metastatic seminoma were gathered. The primary endpoint for all analyses was progression-free survival. The source data of 361 patients, 184 treated with cisplatin-based combinations and 177 treated with carboplatin single agent therapy, were entered into the analysis. Patient characteristics were comparable among the cisplatin-based and the carboplatin single agent treated patient groups with lymph nodes and lungs being the most frequent metastatic sites in 92 and 8% of patients, respectively. Overall, patients treated with single agent carboplatin had an inferior 5-year overall (89 and 94%; P=0.09) and progression-free survival rate (72 and 92%; P< 0.0001) compared with patients receiving cisplatin-based combinations. For all investigated subgroups (based on age, prior radiation therapy, metastatic sites), carboplatin single agent therapy was found to be inferior to cisplatin-based combination chemotherapy. In conclusion, carboplatin single agent therapy cannot be recommended as standard treatment for any patient subgroup with advanced metastatic seminoma and cisplatin-based combination regimens remain the standard of care.

Adolescent↗

PubMed2000

Practical aspects of conducting a pragmatic randomised trial in primary care: patient recruitment and outcome assessment.

BACKGROUND: Conducting a pragmatic randomised trial in primary care is often accompanied by practical problems. Such problems are seldom reported and may constitute useful lessons for researchers planning future trials. AIM: To address the difficulties involved in patient recruitment and to present measures to minimise bias during outcome assessment. METHOD: A recently conducted trial comparing the effects of corticosteroid injections and physiotherapy for painful stiff shoulder was used to illustrate problems related to patient recruitment and outcome assessment. RESULTS: Recruitment of patients was not without difficulties despite careful preparation. Recruitment was discontinued after 20 months, when 109 of the intended 120 patients had been admitted to the trial. The shoulder trial mainly included patient-oriented subjective outcome measures. Subgroup analyses demonstrated that patient preferences might have had some influence on outcome. CONCLUSIONS: General practitioners might be willing or unwilling to participate in research for many reasons. The researcher should take these motivations into account when inviting physicians to take part in research. Strategies to enhance enrolment should be prepared before the start of the trial. When blinding of patients is problematic, patient preferences should be assessed before randomisation and their influence on the outcome studied. Although involving a blinded independent observer enables a more objective assessment of outcome, the success of blinding should be clearly evaluated.

Attitude of Health Personnel↗

PubMed1986

Treatment of metastatic and recurrent cervix cancer with chemotherapy: a randomised trial comparing hydroxyurea with cisdiamminedichloro-platinum plus methotrexate.

In a randomised trial comparing single-agent chemotherapy (hydroxyurea) to combination chemotherapy in advanced cervix cancer, response was seen in 57% (including 13% CR) of patients receiving the combination (DDP + MTX) regimen. Responding patients survived significantly longer (11 months) than either those receiving hydroxyurea or those not responding to combination chemotherapy (4 months). Two patients remain in complete remission for 14+ and 17+ months.

Actuarial Analysis↗

PubMed1978

Randomised trial of a mobile coronary care unit for emergency calls.

A randomised trial was conducted to assess the value of sending a mobile coronary care unit (MCCU) to all emergency calls other than those for children or for patients injured in road-traffic accidents or brawls. Over 15 months 6223 calls for emergency ambulances were considered for the study, but a routine ambulance had to be dispatched on 2583 occasions because the MCCU was not available. A group of 1664 patients was randomly allocated to transport by the MCCU and 1676 patients to routine transport. In these groups the prehospital mortality among patients with heart attacks was 45% and 47%, and no patient survived resuscitation attempts long enough to leave hospital. During the same period general practitioners sent 190 patients with heart attacks to hospital in routine ambulances and none of them died during the interval between the call for the ambulance and arrival at hospital. Although it may be worth equipping all emergency ambulances with a defibrillator, MCCUs as at present envisaged will not appreciably affect mortality from heart attacks.

Ambulances↗