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Conventional management of partial-thickness burn wounds includes the use of paraffin gauze dressing, frequently with topical silver-based antibacterial creams. Some creams form an overlying slough that renders wound assessment difficult and are painful upon application. An alternative to conventional management, moist exposed burn ointment (MEBO), has been proposed as a topical agent that may accelerate wound healing and have antibacterial and analgesic properties. One hundred fifteen patients with partial-thickness burns were randomly assigned to conventional (n = 58) or MEBO treatment (n = 57). A verbal numerical rating score of pain was made in the morning, after burn dressing, and some 8 hours later. Patient pain profiles were summarized by locally weighted regression smoothing technique curves and the difference between treatments estimated using multilevel regression techniques. Mean verbal numerical rating scale pain levels (cm) in week 1 for all patients were highest at 3.2 for the after dressing assessment, lowest in the evening at 2.6, and intermediate in the morning at 3.0. This pattern continued at similar levels in week 2 and then declined by a mean of 0.5 in all groups in week 3. There was little evidence to suggest a difference in pain levels by treatment group with the exception of the postdressing pain levels in the first week when those receiving MEBO had a mean level of 0.7 cm (95% confidence interval, 0.2 to 1.1) lower than those on conventional therapy. MEBO appeared to bring greater pain relief for the postdressing assessment during the first week after burns. This initial relief, together with comparable pain levels experienced on other occasions, indicates that MEBO could be an alternative to conventional burns management.

The rheological properties of mixtures of cationic surfactant (dialkyldimethylammonium chloride) and water are studied for a range of surfactant concentrations. In particular, we investigate rheological signatures of the conformational transformation of the system from lamellar sheets to lamellar vesicles under the action of shear. For a range of rheological test regimes, including transient, steady, and oscillatory shear, this transition is signaled by a critical stress or yield stress involving step changes in sample strain, viscosity, or dynamic moduli. However, only a portion of the sample undergoes the transition, resulting in lamellar sheets coexisting with vesicles. We further show that the transition is reversible in that ramping the stress down from above the critical stress value results in the disappearance of all of the vesicles. The final viscosity of the mixture can be higher or lower than that for the initial untreated material&sbd;possibly reflecting an imbalance in the net generation or annealing of defects in the lamellar structure by the shear treatment. Oscillatory rheometry indicates that a minimum strain is also required to obtain a phase transition. For transient shear, this corresponds to a minimum residence time in the shear field. In general, the critical stresses increase with the surfactant concentration, though they are relatively constant at 15−20 Pa for concentrations between 20 and 40 wt %.

The structure of anhydrous sodium dodecyl sulphate (SDS) was determined using a combination of high resolution, synchrotron, powder X-ray diffraction and molecular modelling techniques, including the use of a systematic search method to select suitable inter-molecular packing configurations for subsequent Rietveld refinement. Anhydrous SDS is monoclinic, space group P21/c, the unit cell dimensions are a=38.915Å,b=4.709Å,c=8.198Åand β=93.29° and the asymmetric unit is comprised of a single SDS molecule. The packing motif consists of double layers of molecules. Molecules in adjacent layers are related by 21axes, whilst within layers the adjacent molecules are related by c glide planes. The sulphur atom in the head group is displaced from the (100) plane by 2.1Å and the methyl carbon is displaced by a perpendicular distance of 1.2Å from the (200) plane. Electrostatic interactions between the headgroups dominate the packing and largely determine the alignment of the hydrocarbon chains with respect to the long axis of the unit cell. The average area per polar head group is 19.4Å2. The present structure is compared with previously determined structures for three hydrated phases of SDS in terms of the observed intermolecular packing motifs.

AimTo evaluate the performance of limbal chamber depth estimation as a means of detecting occludable drainage angles and primary angle closure, with or without glaucoma, in an east Asian population, and determine whether an augmented grading scheme would enhance test performance. MethodA two phase, cross sectional, community based study was conducted on rural and urban areas of Hövsgöl and Ömnögobi provinces, Mongolia. 1800 subjects aged 40 to 93 years were selected and 1717 (95%) of these were examined. Depth of the anterior chamber at the temporal limbus was graded as a percentage fraction of peripheral corneal thickness. An "occludable" angle was one in which the trabecular meshwork was seen in less than 90° of the angle circumference by gonioscopy. Primary angle closure (PAC) was diagnosed in subjects with an occludable angle and either raised pressure or peripheral anterior synechiae. PAC with glaucoma (PACG) was diagnosed in cases with an occludable angle combined with glaucomatous optic neuropathy and consistent visual morbidity. ResultsOccludable angles were identified in 140 subjects, 28 of these had PACG. The 15% grade (equivalent to the traditional "grade 1") yielded sensitivity and specificity of 84% and 86% respectively for the detection of occludable angles. The 5% grade gave sensitivity of 91% and specificity of 93% for the detection of PACG. The interobserver agreement for this augmented grading scheme was good (weighted kappa 0.76). ConclusionsThe traditional limbal chamber depth grading scheme offers good performance for detecting occludable drainage angles in this population. The augmented scheme gives enhanced performance in detection of established PACG. The augmented scheme has potential for good interobserver agreement.

Purpose.The aim of this study was to describe the psychological and social reactions of women with advanced stages of cancer of the cervix during and after radiotherapy.

Purpose.The aim of this study was to describe the physical symptoms experienced by patients with advanced stages of cervical cancer during the first 2 years after radiotherapy.

It can be argued that an ideal teleconferencing system would offer a sense of presence comparable to that afforded by real face-to-face meetings. In contrast, traditional desktop videoconferencing loses essential socially important phenomena such as true perspective views, live facial expressions and tacit body language. This paper reports a prototype concept demonstrator under development at BT Laboratores that addresses these issues in order to make the use of videoconferencing a normal social activity rather than a means of merely getting messages across the channel. The idea is to place participants from different remote sites in a coherent virtual environment naturally extended from the real world. The participants have correct views of each other and the illusion of close proximity. The rationale is to build on the demonstrator and enhance it with increasingly realistic functional components as the relevant technical solutions become available. Results are presented of a stereo-based vision system which can synthesise novel (or virtual camera) perspective views of the scene from two fixed camera views. The technique is currently capable of providing 'look-around' views and a certain degree of navigation capability around the scene. Research issues are discussed together with the practical difficulties that remain to be solved in implementing a true-view, telepresence, videoconferencing system.

In this randomized trial adjuvant cytotoxic portal vein perfusion in patients undergoing surgery for colorectal cancer without liver metastases was assessed to determine whether the incidence of meta-chronous liver metastases could be reduced and survival thereby improved. There were 127 control patients and 117 patients who received adjuvant perfusion. A further 13 patients were excluded following randomization because of cirrhosis in 1, liver metastases at laparotomy in 3 and technical problems with cannulation in 9. Dukes' staging and degree of differentiation were similar in the two groups. There were fewer liver metastases in the perfusion patients and overall survival was improved. However, the benefit appears to be greatest in patients with Dukes' B colon cancer.

A recently described scoring system designed to assess the individual risk of finding serious pathology in patients referred for upper gastrointestinal investigation has been prospectively tested in 1279 patients undergoing first-time endoscopy and 321 patients undergoing radiologic examination. The scoring system has been confirmed to give a reasonable prediction of the likelihood of finding serious pathology in two hospitals with differing endoscopic practice, and also to be applicable to patients attending for radiology. The system works best at defining a low-risk group (score <412, 26% of total) in which the incidence of serious pathology was 3%. All cases of malignancy (n = 55) occurred in patients scoring >464 (50% of total). A simple table is described that allows for the easy calculation of score at a glance without the use of a computer. We believe that this scoring system, which can be implemented in seconds, is the simplest yet described and that it could prove to be a useful educational aid.

Socioeconomic differentials in the uptake of medical care in men were investigated using data from the General Household Survey (1974-76 and 1979-80). Hospitalisation, attendance at out patient clinics, and consultation with doctors were higher in local authority tenants than in owner occupiers. Men belonging to the manual socioeconomic groups also used services and consulted doctors more often than those in the non-manual groups. Hospitalisation among men was highest among manual workers living in local authority properties without access to car(s) (OR 1.92). Highest attendance at outpatient clinics (OR 1.60) was seen among local authority tenants in urban areas belonging to manual groups. However, consultation with doctors was highest among urban manual workers living in local authority properties but with access to car(s) (OR 1.72). The implications of these findings for resource allocation are discussed.

Changing Childbirth emphasizes the notion of women having an ‘Informed choice’ through being aware of all the options open to them, knowledge of both the medicalized and demedicalized approaches to childbirth should open up the possibility for this choice. This research suggests that the ‘Informed choice’, as it 15 currently received, may not necessarily lead to any changes in childbirth experience due to certain fundamental cultural needs of women in our society.

This paper investigates the influence on patient survival of an individual clinician's experience with a particular treatment regimen and the collective experience of the centre through which the patient is recruited to a particular clinical trial. Data were available from two series of randomized trials, one series in small cell and the other in non-small cell lung cancer, which were conducted by the Medical Research Council Lung Cancer Working Party. Successive small cell trials used the same chemotherapy regimen and successive non-small cell trials the same radiotherapy regimen. We found no evidence that either the degree of experience of individual clinicians with the regimen or the participation in terms of number of patients recruited to centres influenced patient survival. There is a strong suggestion, in non-small cell lung cancer that, as clinicians' experience with the regimen extended, they became increasingly likely to admit patients in poor condition to the trials. We stress how important it is to take account of patient prognostic characteristics in such an analysis, as we found that unadjusted comparisons suggested negative influences of increasing experience with the regimen. The implications for routine audit are self evident, in particular that it is not a substitute for the randomized controlled trial.

An analysis of 351 HT treatment sessions administered to 101 patients receiving radiotherapy and hyperthermia (RT + HT) who were entered into Phase III concurrent randomized trials for recurrent (BrR) and intact (BrI) breast tumours is presented. A complete response (CR) was recorded in 50 of 84 (595%) fields in the case of recurrent breast patients and in 10 of 17 (59%) fields in the case of the intact breast patients. In comparison, 15 of 60 (25%) patients entered into BrR who received RT alone and 8 of 12 (667%) patients receiving RT alone entered into BrI trial achieved CR. A set ot thermal parameters is defined and evaluated on a treatment by treatment basis. Patient and tumour characteristics influential on CR are identified and thermal parameters which have additional prognostic value are investigated. Multivariate logistic analysis of the non-thermal data showed that maximum depth of tumour, presence or history of disease outside the treated area and RT regimen were most influential on CR. Tumour volume (cm3) (OR = 0.996, 95% CI = 0.993-1 0004, p = 008) was not a strong prognostic covariate; tumour area and linear dimensions were even less significant (p = 0.41). The cumulative minimum thermal isoeffect dose (equivalent minutes at 43°C) accrued over the 1st, 1st and 2nd, and 1st, 2nd and 3rd treatment sessions was the only thermal parameter to exhibit an association with CR consistently. Other thermal parameters found to contribute to the predictive models were MINTIME > 42°C calculated for the 1st treatment session and %sensors > 43°C (peak) calculated for the 2nd treatment session.

A scheme for the management of the common urological presentations encountered in spinal cord damaged patients is provided in flow chart form. The diagrams indicate how urological investigations can be used to greatest effect. A simple computer programme based on these charts is available.

The urological management of 1126 consecutive patients treated at the Mersey Regional Spinal Injuries Centre between 1947 and 1983 is reviewed. It is concluded that when urodynamics is included in the urological investigative profile, in addition to clinical, biochemical, intravenous urographie and cysto-urethrographic assessments, then treatment failure is less likely.

The need for sample size calculations is briefly reviewed: many of the arguments against small trials are already well known, and we only cursorily repeat them in passing. Problems that arise in the estimation of sample size are then discussed, with particular reference to survival studies. However, most of the issues which we discuss are equally applicable to other types of study. Finally, prognostic factor analysis designs are discussed, since this is another area in which experience shows that far too many studies are of an inadequate size and yield misleading results.

Pathology observer agreement studies are clearly important in the development of new pathology assessments and in the quality control of those assessments in common use. Setting up such studies, and reporting and interpreting their results requires careful thought and statistical expertise. Investigators are advised to seek collaboration with a statistician before embarking on these studies. Pathology reference panel reviews in multicentre studies are useful for checking eligibility when there is a high level of disagreement on the eligibility criterion between local pathologists and the reference panel members, but good agreement between members of the panel. However, such situations are uncommon.

A total of 458 eligible patients, from 21 centres, with microscopically confirmed SCLC were allocated at random to three chemotherapy regimens, each given at 3-week intervals. In two regimens, etoposide, cyclophosphamide, methotrexate and vincristine were given for a total of either three courses (ECMV3) or six courses (ECMV6). In the third regimen, etoposide and ifosfamide were given for six courses (E16). Patients with limited disease also received radiotherapy to the primary site after the third course of chemotherapy in all three groups. As reported by clinicians, 59% of the ECMV3, 67% of the ECMV6 and 63% of the EI6 patients experienced moderate or severe adverse reactions to their chemotherapy. The major symptoms of disease, cough, haemoptysis, chest pain, anorexia, and dysphagia, were palliated in 63% or more of patients and the median duration of palliation was 63% or more of survival, the results being similar in the three groups. Among patients with poor overall condition, physical activity and breathlessness on admission, the proportions who improved were higher in the EI6 group but the differences were small. In all three groups, levels of anxiety fell substantially during treatment. Levels of depression were lower and showed little change. As assessed by patients using a daily diary card, the patterns of nausea, vomiting, activity and mood, associated with courses of chemotherapy were very similar in the three groups. In the EI6 group there was less dysphagia and better overall condition between courses, but these advantages need to be weighed against the inconvenience of the 24-h infusions required, compared with the 30-min infusions of the other two regimens. As reported in the companion paper (MRC Lung Cancer Working Party, 1993a) there was no statistically significant survival advantage to any of the three regimens, although the results do not exclude the possibility of a minor survival advantage with the two six-course regimens. In conclusion, there was no major clinical gain from continuing chemotherapy beyond three courses or from using the ifosfamide regimen.

A total of 458 eligible patients, from 21 centres, with histologically or cytologically confirmed SCLC were allocated at random to three chemotherapy regimens, each given at 3-week intervals. In two regimens, etoposide, cyclophosphamide, methotrexate and vincristine were given for a total of either three courses (ECMV3) or six courses (ECMV6). In the third regimen, etoposide and ifosfamide were given for six courses (EI6). Patients with limited disease (56% of the total) also received radiotherapy to the primary site after the third course of chemotherapy in all three groups. A partial response occurred in 45% of 144 ECMV3 patients, 48% of 141 ECMV6, and 53% of 141 EI6 patients assessed, and a complete response in a further 15%, 9%, and 13% respectively, giving total response rates of 60%, 57%, and 67%, respectively. There was no overall survival advantage to any of the three regimens. At 1 year, 24%, 29%, and 30% of patients were alive, and at 2 years 7%, 8%, and 9%, respectively. The median survival time was 7.4 months in the ECMV3 group, 8.6 months in the ECMV6 group and 8.8 months in the EI6 group. The individual factors: poor performance status, extensive disease, the presence of dysphagia and a raised white blood cell count on admission adversely affected prognosis. The results do not exclude the possibility of a minor survival advantage with the two 6-course regimens. The findings on quality of life are presented in the companion paper (MRC Lung Cancer Working Party, 1993b).

The motivation for proposing sequential methods for cancer clinical trials is presented, and the methodology examined by re-analysing two completed phase III cancer trials of the Lung Cancer Working Party of the British Medical Research Council. The reanalysis proceeds as if the trials had been designed with a planned series of interim analyses governing stopping. Specifically, the triangular and double-triangular tests were applied. The sequential reanalysis gave a substantial reduction in the number of patient required, and deaths observed, for conclusions to be reached in comparison with the completed studies. In each case, the sequential analysis was stratified for baseline prognostic factors which were seen to be important at the first interim analysis.

Two policies of palliative thoracic radiotherapy for NSCLC have been compared in a randomised multicentre controlled trial aimed at simplifying the palliative treatment of patients with poor performance status. A total of 235 patients were entered. They had inoperable, microscopically confirmed disease, too advanced for 'curative' radiotherapy. Their main symptoms were related to the primary intrathoracic tumour even if metastases were present, and they had a poor performance status. Patients were allocated at random to regimens of either 17 Gy given in two fractions of 8.5 Gy 1 week apart (F2 regimen, 117 patients), or a single fraction of 10 Gy (F1 regimen, 118 patients). Two patients (one in each group) were excluded from all analyses because they were found to have had previously treated malignant disease and had been admitted in error. On admission, 95% of the 233 eligible patients had cough, 47% haemoptysis, 59% chest pain, 64% anorexia, and 16% dysphagia. As assessed by the clinicians, these symptoms were palliated in high proportions of patients, ranging in the F2 group from 48% for cough to 75% for haemoptysis, and in the F1 group from 55% for anorexia to 72% for haemoptysis and chest pain. For all five symptoms the median duration of palliation was 50% or more of survival. All these results were similar in the two treatment groups. In contrast, on daily assessment by the patients using a diary card, those treated with the F2 regimen experienced substantially more dysphagia, which was recorded in 56% of the patients compared with 23% in the F1 group (difference 33%: 95% confidence interval 17-48%). The median survival from randomisation was 100 days in the F2 group and 122 days in the F1 group. The F1 regimen, as it requires only a single attendance for treatment, is recommended as a palliative regimen for patients with inoperable NSCLC and a poor performance status.

Clinical trials involving quality of life measurement published in the literature suffer from important weaknesses due to the lack of information on numerous topics. The psychometric properties of the instruments are often lacking as well as data on the number of patients treated and analyzed. The handling of missing data is rarely documented. In order to facilitate the reporting of trials and the evaluation of published results, this article proposes a set of general guidelines for the reporting of clinical trials which include a quality of life assessment. A checklist designed to assist authors is appended.

Standardization in the choice of quality of life (QOL) instruments and their application in randomised clinical trials have been advocated and generally accepted. However, there is now an urgent need to address the problems relating to the analysis and presentation of the data thus generated. There are intrinsic difficulties associated with QOL data, namely its multidimensional nature, attrition and missing data, and there is no consensus as to how these problems should be dealt with. This paper therefore considers there problems using interim data from a large Medical Research Council randomised trial in patients with small cell lung cancer and a poor prognosis, in which attrition and compliance are major concerns. Three possible approaches to the analysis of these data, which use different subsets of patients, are examined in detail. The strengths and weaknesses of these three methods are discussed, and examples of their use in the literature are given and compared with other reported approaches. The need for a standard definition of compliance is also emphasised, and a method of presentation suggested. The best current advice is that QOL data should be analysed in a number of different ways, and conclusions reached only when consistency is seen.

Analysis of routinely published abortion and fertility data for England and Wales between 1968 and 1980 shows that the age-specific abortion rates increased from 1968 until about 1973 when the rates peaked for all ages; rates then declined until 1977 but have subsequently returned to higher levels. Two factors are implicated: (1) the recent changes are related to parallel changes in the fertility rate; but (2) there is also a tendency for recent cohorts of women to resort to abortion more readily. These relationships are derived from analyses of fertility rates and abortion ratios, the proportion of conceptions that result in abortions. The results are discussed in terms of attitudes and practices related to birth control.

Trends in primary care in the United Kingdom were studied using the diagnostic information available at Intercontinental Medical Statistics Ltd (IMS) for 1969-80. Total consultation rates overall showed an increase until 1978 when they started to decline. Diseases of the respiratory system showed a decline for first consultations. Diseases of the musculoskeletal and connective tissue and diseases of the nervous system and sense organs showed an increase. Diseases of the respiratory system, circulatory system, and mental disorders accounted for 15.4%, 11.2%, and 9.6% respectively of the total consultations in 1980. Neuroses and personality disorders accounted for the highest consultation rates in general practice. This study identifies areas for further research in general practice and the potential of this data base, if expanded, for the continuous monitoring of morbidity in primary care.

1. The effects of feeding a screw-press expelled cottonseed meal (CSM) to laying hens at dietary concentrations of up to 300 g/kg, were studied over a 10 week period.2. The overall performance of hens fed on a 75g CSM/kg diet was not significantly different from controls but a 300g CSM/kg diet, containing 255 mg free gossypol/kg and 87 mg cyclopropenoid fatty acids (CPFA)/kg and giving daily intakes per hen of 26.2 mg free gossypol and 9.0 mg CPFA, significantly reduced food intake (P<0.01) and egg production (P<0.01). The 150g CSM/kg diet (daily intakes of 14.6 mg free gossypol and 4.8 mg CPFA per hen) did not produce adverse effects initially but egg production was slightly depressed towards the end of the experimental period.3. Treatment of the CSM with a solution of ferrous sulphate hepta-hydrate for inclusion in a 300g CSM/kg diet (100 mg/kg supplemental dietary iron) further reduced food intake (P<0.05) and egg production (P<0.05).4. Storage of eggs at warm temperatures for up to 1 month did not lead to discolourations of any kind in the CSM diet groups, but resulted in yolk mottling, a condition reduced by treatment of the CSM with iron.5. Storage of eggs at cold temperatures for 3 months resulted in brown yolk discolouration and the initial stages of pink albumen discolouration in the 300g CSM/kg diet group; the brown yolk discolouration was reduced by treatment of the CSM with iron.

1. Broiler chicks fed on a diet containing 500 g/kg expeller copra cake of high residual oil content not only retained less dry matter and gained less weight than those fed on a control diet with no copra, they also experienced difficulty in achieving similar food intakes.2. Chicks given the 500 g/kg copra ration initially displayed an excited behaviour pattern, which may have developed out of frustration as they could neither derive adequate nourishment from their food nor increase food intakes sufficiently to allow them to achieve their genetic potential for growth.3. Chicks however showed considerable adaptation in that efficiency of food utilisation and intakes were increased gradually; the latter appeared to be partly regulated by an increased intake of water that was associated with copra feeding. The surface area of the intestines was also increased in order to facilitate the absorption of nutrients, and greater proportions of the nutrients absorbed were converted into body weight.4. There were no significant differences in 7-week body weights of chicks fed the control, 125 g/kg and 250 g/kg copra diets. Although weight gains at the 500 g/kg inclusion rate were lower, the carcases of these chicks had less abdominal fat and were consequently leaner.

Analysing quality of life (QOL) data may be complicated for several reasons, such as: repeated measures are obtained; data may be collected on ordered categorical responses; the instrument may have multidimensional scales, and complete data may not be available for all patients. In addition, it may be necessary to integrate QOL with length of life. The major undesirable effects of missing data, in QOL research, are the introduction of biases due to inadequate modes of analysis and the loss of efficiency due to reduced sample sizes. Currently, there is no standard method for handling missing data in QOL studies. In fact, there are very few references to methods of handling missing data in this context. The aim of this paper is to provide an overview of methods for analysing incomplete longitudinal QOL data which have either been presented in the QOL literature or in the missing data literature. These methods of analysis include complete case, available case, summary measures, imputation and likelihood‐based approaches. We also discuss the issue of bias and the need for sensitivity analyses. © 1998 John Wiley & Sons, Ltd.

Analysing quality of life (QOL) data may be complicated for several reasons, such as: repeated measures are obtained; data may be collected on ordered categorical responses; the instrument may have multidimensional scales, and complete data may not be available for all patients. In addition, it may be necessary to integrate QOL with length of life. The major undesirable effects of missing data, in QOL research, are the introduction of biases due to inadequate modes of analysis and the loss of efficiency due to reduced sample sizes. Currently, there is no standard method for handling missing data in QOL studies. In fact, there are very few references to methods of handling missing data in this context. The aim of this paper is to provide an overview of methods for analysing incomplete longitudinal QOL data which have either been presented in the QOL literature or in the missing data literature. These methods of analysis include complete case, available case, summary measures, imputation and likelihood-based approaches. We also discuss the issue of bias and the need for sensitivity analyses. © 1998 John Wiley & Sons, Ltd.

Geographical variation in the standardized years of potential life lost ratio (SYPLR) in women aged 20-74 dying from breast cancer has been mapped by local authority district in England and Wales and compared with the variation as described by the standardized mortality ratio (SMR). The geographical distribution of areas of low and high SMRs is similar to that observed some 15 years earlier, showing an increase from north to south. In contrast, the pattern of SYPLRs shows a less obvious trend. Years of life lost because of breast cancer mortality were particularly high in eight of the 401 county districts (SYPLR 1.22-1.48) and particularly low in nine (0.60-0.86). Mapping SYPLRs for breast cancer gives a different pattern from mapping SMRs, and one which is possibly more appropriate for targeting resources in circumstances in which death at younger age will have major social consequences. Care is required in interpreting maps indicating high and low rates in the presence of multiple comparisons. However, the range of values observed is suggestive of the need to investigate districts with contrasting values of SYPLR with respect to the inter-relationships between sociodemographic characteristics, duration of symptoms, clinical presentation and treatment efficacy.

The role of post-operative radiotherapy for patients with non-small-cell lung cancer (NSCLC) is unclear despite five previous randomised trials. One deficiency with these trials was that they did not include adequate TNM staging, and so the present randomised trial was designed to compare surgery alone (S) with surgery plus post-operative radiotherapy (SR) in patients with pathologically staged T1-2, N1-2. M0 NSCLC. Between July 1986 and October 1993, 308 patients (154 S, 154 SR) were entered from 16 centres in the UK. The median age of the patients was 62 years, 74% were male, > 85% had normal or near normal levels of general condition, activity and breathlessness, 68% had squamous carcinoma, 52% had had a pneumonectomy, 63% had N1 disease and 37% N2 disease. SR patients received 40 Gy in 15 fractions starting 4-6 weeks post-operatively. Overall there was no advantage to either group in terms of survival, although definite local recurrence and bony metastases appeared less frequently and later in the SR group. In a subgroup analysis, in the N1 group no differences between the treatment groups were seen, but in the N2 group SR patients appeared to gain a one month survival advantage, delayed time to local recurrence and time to appearance of the bone metastases. There is, therefore, no clear indication for post-operative radiotherapy in N1 disease, but the question remains unresolved in N2 disease.

This randomised trial was conducted to compare a four-drug chemotherapy regimen as a control vs a less intensive two-drug regimen in terms of quality of life (QL), tumour response and survival in the palliative treatment of patients with small-cell lung cancer (SCLC) and poor prognosis. A total of 310 patients with extensive SCLC or limited disease but poor performance status were allocated at random to two chemotherapy regimens, each given on 3 consecutive days at 3 week intervals for three cycles: etoposide, cyclophosphamide, methotrexate and vincristine (ECMV, 154 patients) or etoposide and vincristine (EV, 156 patients). QL was assessed by patients using the Rotterdam Symptom Checklist, the Hospital Anxiety and Depression Scale and a daily diary card. Specific disease- and treatment-related symptoms were recorded by clinicians. The levels of palliation were high and similar in the two groups, although the ECMV regimen was on balance superior in palliating physical symptoms and reducing psychological distress. The EV regimen caused less toxicity, particularly mucositis, which, using Kaplan-Meier curves, occurred in an estimated 34% of patients compared with 54% in the ECMV group. The estimated rates of WHO grade 2 or worse haematological toxicity were 21% in the EV compared with 38% in the ECMV patients. There was no overall difference in response or survival; the median survival periods were 141 days in the ECMV group and 137 in the EV group and the survival rates 37% and 38% at 6 months and 12% and 10% at 1 year respectively. Nevertheless, 37 ECMV patients died within 3 weeks of starting the first cycle of chemotherapy (24 of them during the 2nd week) compared with 18 (9) EV patients. The EV regimen is a useful palliative regimen for patients with SCLC and poor prognosis.