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Nurse-led follow-up and conventional medical follow-up in management of patients with lung cancer: randomised trial |
Moore S, Corner J, Haviland J, Wells M, Salmon E, Normand C, Brada M, O'Brien M, Smith I |
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Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. Health technology The health technology examined in the study was nurse-led follow-up in the management of patients with lung cancer. Conventional medical follow-up was considered as the comparator.
Type of intervention Secondary prevention and tertiary prevention.
Economic study type Cost-effectiveness analysis.
Study population The study population comprised patients with lung cancer who had completed their initial treatment and were expected to survive for at least 3 months. Patients were considered to be ineligible if they were receiving cancer treatment, were having close medical supervision, or had a poor prognosis or performance status.
Setting The study was conducted at a specialist cancer hospital and three local cancer units, in London.
Dates to which data relate The dates to which the data relate were not reported. 1999 and 2000 prices were used.
Source of effectiveness data The effectiveness data were gathered from a single prospective study.
Link between effectiveness and cost data The costing was undertaken on the same patient group as that used in the effectiveness study.
Study sample The intended sample size was 200 patients to detect a difference of 10 between mean scores on the patient satisfaction sub-scales, and on the sub-scales of quality of life score questionnaire. This assumed a standard deviation (SD) of 25, 80% power and 5% significance (two-sided test). Of the 271 patients selected to participate in the trial, 203 (75%) agreed to participate and were randomly allocated to receive either nurse-led follow-up (n=100) or conventional medical follow-up (n=103). One patient was later found to be ineligible for the study, leaving 99 patients in the nurse-led follow-up group and 103 patients in the conventional medical group for analysis.
The mean age of the patients was 67 years (SD 8.8, range: 45 - 89). The majority of the patients were men. There were 74 (75%) men in the nurse-led follow-up group and 66 (64%) in the control group.
Study design The study was a randomised trial that was conducted at a specialist cancer hospital and three local cancer units. For randomisation, the patients were stratified according to hospital and treatment intent. An independent trials office was responsible for the randomisation. The outcome measures were assessed at the end of four different follow-up periods. These were 3, 6 and 12 months after randomisation, and after 12 months of follow-up.
Analysis of effectiveness The analysis of the clinical study was conducted on the basis of treatment completers only. The groups were shown to be comparable at baseline in terms of their clinical characteristics, scores for quality of life and patient satisfaction. The primary outcomes were quality of life and patient satisfaction. Quality of life was assessed using the European Organisation for Research and Treatment of Cancer's (EORTC) core questionnaire about quality of life and module about lung cancer. Patient satisfaction was assessed with a questionnaire that incorporated three validated measures and that was tested in a pilot study. The Mann-Whitney U test was used to compare outcome sub-scales between the groups.
The secondary end points included overall survival, symptom-free survival and progression-free survival. A Kaplan-Meier survival analysis was used to estimate median survival, while the logrank test was used to compare secondary end points.
General practitioner (GP) satisfaction was assessed at the end of study participation.
Effectiveness results Patients in the intervention group rated their dyspnoea as less severe at 3 months than did patients in the control group, (p=0.03). These patients also had better scores for emotional functioning, (p=0.03), and less peripheral neuropathy, (p=0.05), at 12 months.
The intervention group patients scored significantly better in most satisfaction sub-scales at 3, 6, and 12 months, (p<0.01 for all sub-scales at 3 months).
When length of follow-up from randomisation was taken into account, the Kaplan-Meier estimates of median survival time were similar, 9.2 months (95% confidence interval, CI: 6.2 - 12.1) in the intervention group versus 10.4 months (95% CI: 7.6 - 13.2) in the control group, (p=0.99);
the Kaplan-Meier estimates of median time to symptomatic progression were 6.0 months (95% CI: 4.7 - 7.3) in the intervention group and 10.2 months (95% CI: 5.9 - 14.6) in the control group, (p=0.01); and
time to objective progression was 8.3 months (95% CI: 5.5 - 12.2) in the intervention group versus 10.2 months (95% CI: 5.9 - 14.5) in the control group, (p=0.47).
No significant differences in GP satisfaction were seen between the two groups.
Clinical conclusions The nurse-led model of follow-up was acceptable to lung cancer patients, as they were highly satisfied and were not at a disadvantage.
Measure of benefits used in the economic analysis The authors did not develop a summary benefit measure. The analysis was therefore categorised as a cost-consequences study.
Direct costs The direct costs were for visits by GPs and nursing staff (based on Netten and Curtis' study), hospital treatment (based on standard costs reported by the Department of Health) and tests and procedures (from Stevens' study). The costs obtained were in sterling and related to 1999 - 2000. A currency conversion was not reported. The direct costs were not discounted since the follow-up period was less than 2 years.
Statistical analysis of costs The total costs per patient for 3, 6 and 12 months after randomisation were treated stochastically. The Mann-Whitney U test was used to compare the two groups. Median values were reported due to the skewed distributions of the outcome variables.
Indirect Costs No indirect costs were included in the analysis.
Sensitivity analysis A sensitivity analysis was not carried out.
Estimated benefits used in the economic analysis Cost results After 3 months, the cost per patient was Euro 221.50 (60.12 - 869.62) for the nurse-led intervention and Euro 288.50 (154.00 - 671.00) for the conventional approach, (p=0.18).
After 6 months, the cost per patient was Euro 369.50 (56.00 - 1,432.00) for the nurse-led intervention and Euro 364.00 (154.00-1181.25) for the conventional approach, (p=0.40).
After 12 months, the cost per patient was Euro 696.50 (227.25 - 2,318.75) for the nurse-led intervention and Euro 744.50 (298.00 - 2,362.75) for the conventional approach, (p=0.66).
Synthesis of costs and benefits No synthesis of the costs and benefits was conducted.
Authors' conclusions Follow-up of patients with lung cancer led by clinical nurse specialists is safe, acceptable and cost-effective.
CRD COMMENTARY - Selection of comparators The reason for the choice of the comparator was clear, conventional medical follow-up was the standard current practice in the authors' setting. You should decide if this is a valid comparator in your own setting.
Validity of estimate of measure of effectiveness The analysis used a randomised controlled trial, which was appropriate for the study question. The study sample appears to have been representative of the study population, although only 75% of those patients eligible agreed to participate. The patient groups were shown to be comparable at analysis. However, although a randomised controlled trial was conducted, the outcomes appear to have been analysed for treatment completers only.
Validity of estimate of measure of benefit The authors did not derive a summary measure of health benefit.
Validity of estimate of costs The perspective adopted, a health and social perspective, was unclear. This makes it very difficult to determine whether all the relevant cost categories have been included. It would have been more appropriate to have adopted a societal perspective. The exclusion of travel costs and loss of income might have biased the results in favour of conventional medical follow-up. The unit costs were obtained mainly from published sources, and were then used to derive a total cost per patient for each period of follow-up. The unit costs and the quantities were not reported, hence hindering any replication of the study to other settings. Sensitivity analyses were not conducted, although these would have helped to deal with any uncertainty surrounding the costs. The costs obtained were in sterling. However, all the costs were reported in Euros and no currency conversion was stated. Discounting was unnecessary since all the costs were incurred during one year.
Other issues The authors compared their findings with those of another published study (Grande et al., see Other Publications of Related Interest). The authors reported a number of limitations of their study. For instance, a high rate of attrition and a high number of outcomes analysed (which would imply that some findings may have occurred by chance). In addition, they suggested that the results from patients investigated at 6 and 12 months should be interpreted with caution.
Implications of the study The authors recommend the replication of the study at other centres in the United Kingdom to confirm the generalisability of the findings. However, the level of costing information reported by the authors may hinder this suggestion.
Source of funding Funding from the NHS Research and Development National Cancer Programme and Macmillan Cancer Relief.
Bibliographic details Moore S, Corner J, Haviland J, Wells M, Salmon E, Normand C, Brada M, O'Brien M, Smith I. Nurse-led follow-up and conventional medical follow-up in management of patients with lung cancer: randomised trial. BMJ 2002; 325: 1145-1147 Other publications of related interest Grande GE, Todd CJ, Barclay SI, Farquhar MC. Does hospital at home for palliative care facilitate death at home? Randomised controlled trial. BMJ 1999;309:1340-2.
Stevens W, Grieve R, Normand C. Costing health care interventions for modelling cost-effectiveness in the UK. London: London School of Hygiene and Tropical Medicine; 2000.
Netten A, Curtis L. Unit costs of health and social care. Canterbury: University of Kent, Personal Social Services Research Unit; 2000.
Moore S, Corner J, Fuller F. Development of nurse-led follow-up in the management of patients with lung cancer. Nursing Times Research 1999;4:432-45.
Fayers P, et al. EORTC QLQ-30 scoring manual. Belgium: EORTC Study Group on Quality of Life; 1995.
Indexing Status Subject indexing assigned by NLM MeSH Aged; Aged, 80 and over; Cancer Care Facilities; Cost-Benefit Analysis; Disease-Free Survival; Family Practice /economics; Female; Follow-Up Studies; Hospitalization /economics; Humans; Lung Neoplasms /economics /nursing; Male; Middle Aged; Patient Satisfaction; Quality of Life AccessionNumber 22002008293 Date bibliographic record published 31/10/2003 Date abstract record published 31/10/2003 |
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