|
Evaluation of nurse-led follow up for patients undergoing pelvic radiotherapy |
Faithfull S, Corner J, Meyer L, Huddart R, Dearnaley D |
|
|
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 use of nurse-led care for the follow-up of patients treated with radical radiotherapy for prostate and bladder cancer. The intervention comprised an initial assessment at the first clinical appointment and continued contact throughout treatment until 12 weeks from the start of radiotherapy. The patients and families were provided with informative leaflets, and telephone contacts were maintained between clinic appointments to assess health status. Twenty-minute nurse-led appointments were scheduled.
Economic study type Cost-effectiveness analysis.
Study population The study population comprised men undergoing radical (greater than 60 Gy) radiotherapy for prostate or bladder cancer.
Setting The setting was secondary care. The economic study was conducted in the UK.
Dates to which data relate The effectiveness and resource use data were gathered between September 1995 and January 1997. The price year was not reported.
Source of effectiveness data The effectiveness evidence was derived from a single study.
Link between effectiveness and cost data The costing was conducted prospectively on the same sample of patients as that used in the effectiveness study.
Study sample Power calculations were performed in the preliminary phase of the study. These suggested that a sample of 164 patients would be required to detect an absolute difference of 20% in morbidity between the study groups, with a power of 80% and a significance level of 5%. Of an initial group of 136 patients, 4 were not eligible, 6 refused to participate, and 11 were missed because they started radiotherapy before the researcher could contact them. Thus, a final sample of 115 patients was enrolled, 58 in the intervention group and 57 in the control group. The patients in the intervention group had a mean age of 70 years (age range: 51 - 80) and 82% had prostate cancer. In the control group, the mean age was 70 years (age range: 49 - 83) and 83% had prostate cancer.
Study design This was a prospective, randomised controlled trial that was conducted at a single centre. The Clinical Trials Unit at the Institute of Cancer Research, Sutton, randomised the patients to the study groups. The randomisation was stratified to provide a balanced representation of men with prostate and bladder cancer in the two groups. The length of follow-up was 12 weeks and the outcomes were generally assessed at baseline, 1, 3, 6 and 12 weeks (but this varied for the different measures). The authors stated that some patients were lost to follow-up. The actual number of patients unavailable for assessment depended on the outcome measure, as self-reported data were used. Questionnaire compliance was high (96%) initially, but it decreased over time (88% at week 6). The authors did not state whether there were differences in the questionnaire compliance rate between the groups.
Analysis of effectiveness The analysis of the clinical study appears to have been based on treatment completers only. The outcomes used in the effectiveness analysis were:
self-assessment of symptoms (13-item questionnaire with 100-mm visual analogue scale),
acute treatment toxicity (RTOG/EORTC observer-toxicity scale),
patient health status (EORTC QLQ C30), and
patient satisfaction (questionnaire based on the Newcastle satisfaction with nursing scale; patients were asked to return the questionnaire anonymously by post).
The issue of inter-observer variability was addressed and very high agreement scores were found between the nurses and physicians who collected the data. The study groups were comparable at baseline in terms of the patient characteristics, treatment received and stage of disease. Uni- and multi-regression analyses were conducted to test the impact of some baseline factors and the randomisation approach on the results of the study.
Effectiveness results After one week, patients in the intervention groups showed better scores than those in the control group for seven symptoms (nocturia, activity and bladder symptoms, constipation, cramp or abdominal pain, fatigue, sickness, and feeling unwell). However, at 3, 6 and 12 weeks, there was no statistically significant difference in symptom scores between the study groups. The authors noted that the lack of data prevented any conclusion being drawn about the long-term impact of the intervention.
Similar results were observed for the RTOG/EORTC and EORTC QLQ C30 scores during the study period, with the exception of constipation, (p=0.01), and physical functioning, (p=0.05). These scores were better in the intervention group.
The patients in the intervention group were significantly more satisfied with the follow-up care than the control patients were, (p<0.002). The regression analysis showed that none of the baseline factors or the randomisation approach had a statistically significant impact on the results of the analysis.
Clinical conclusions The effectiveness analysis showed that, compared with standard care, nurse-led care provided safe follow-up for patients treated with radical radiotherapy for prostate and bladder cancer. The patients were more satisfied with the new intervention.
Measure of benefits used in the economic analysis The health outcomes were left disaggregated and no summary benefit measure was used in the economic evaluation. A cost-consequences analysis was therefore performed.
Direct costs Discounting was not relevant since the costs per patient were incurred during a short time (3 months after the first radiotherapy). The health services included in the economic analysis were service costs, microbiology costs and medication expenses. No patient costs were included. The service costs were fore overnight stay, day case, outpatient appointments, telephone contacts and the radiotherapy nurse. The unit costs were only analysed separately from the quantities of resources for the cost components included in the service cost. The cost of radiotherapy was not considered in the analysis because it was relatively constant over the study period. The cost/resource boundary adopted in the study was not stated explicitly, but it appears to have been that of the hospital. The costs were estimated from actual data coming from the hospital accounting system and prescription records. The resource use data were estimated from the sample of patients involved in the effectiveness study. The price year was not reported.
Statistical analysis of costs The statistical significance of the difference between the total costs evaluated in the two study groups was tested using the Mann-Whitney U-test.
Indirect Costs The indirect costs were not included in the economic evaluation.
Sensitivity analysis Sensitivity analyses were not conducted.
Estimated benefits used in the economic analysis See the 'Effectiveness Results' section.
Cost results The service costs were 23,102 in the intervention group (n=58) and 33,650 in the control group (n=57), that is, 31% lower in the intervention group. The microbiology costs were also lower in the intervention group than the control (557 versus 901, 38% difference), as were the medication costs (704 versus 755, 7% difference). Consequently, the total costs were 31% lower in the intervention group (24,363) than the control (35,306). This difference was statistically significant. Outpatient visits were cheaper when carried out by nurses rather than physicians.
Synthesis of costs and benefits A synthesis of the costs and benefits was not relevant because a cost-consequences analysis was conducted.
Authors' conclusions The nurse-led follow-up was safe and led to a significant reduction in the hospital costs. The patients perceived it to be beneficial in comparison with standard care.
CRD COMMENTARY - Selection of comparators The rationale for the choice of the comparator was clear. The authors compared the new intervention with the care routinely delivered in the study setting. A detailed description of standard care was provided. You should decide whether it represents an appropriate comparator in your own setting.
Validity of estimate of measure of effectiveness The analysis of effectiveness used a randomised trial, which was appropriate for the study question. The length of and loss to follow-up were reported. The study groups were shown to have been comparable at baseline and statistical tests were conducted to assess the impact of potential confounding factors. The authors accurately described the sample selection process and reported the percentage of patients who refused to participate. Power calculations were performed in the preliminary phase of the study, but the target sample size was not reached. This, and the loss to follow-up, meant the study was underpowered to detect statistically significant differences in some of the outcome measures. The method of randomisation was not described and the analysis of the clinical study was based on treatment completers only. These last issues may have affected the internal validity of the analysis.
Validity of estimate of measure of benefit No summary benefit measure was used in the analysis. Hence, a cost-consequences analysis was conducted.
Validity of estimate of costs The perspective adopted in the study was clearly that of the hospital, although this was not explicitly stated, because hospital data were used to estimate the costs. A justification was provided for the exclusion of radiotherapy costs, although the impact of such an exclusion on the estimated total costs is likely to have been negligible. The unit costs and resources used were only analysed separately for some categories of costs. The price year was not mentioned, thus making reflation exercises in other settings difficult. Standard statistical tests were conducted when comparing the costs observed in the two groups. The cost estimates were specific to the study setting and sensitivity analyses were not conducted.
Other issues The authors made some comparisons of their results with those of other studies evaluating the nurse intervention in other health care fields, such as paediatrics or mental illness. However, the issue of the generalisability of the study results to other settings was not addressed and sensitivity analyses were not performed. This limits the external validity of the analysis. Consequently, caution is required when extrapolating the results of the study since setting-related estimates were used. The conclusions of the study confirmed the initial hypothesis.
Implications of the study The authors stated that future research should be conducted to confirm the benefits of the nurse-led intervention. It was stressed that the intervention was "nurse-led" rather than "nurse-alone". Hence, the focus was on multidisciplinary team care.
Source of funding Supported by a Nursing Clinical Research Fellowship provided by the Cancer Research Campaign, and the Institute of Cancer Research. The clinical work was undertaken at The Royal Marsden NHS Trust, which is part funded by the NHS Executive.
Bibliographic details Faithfull S, Corner J, Meyer L, Huddart R, Dearnaley D. Evaluation of nurse-led follow up for patients undergoing pelvic radiotherapy. British Journal of Cancer 2001; 85(12): 1853-1864 Indexing Status Subject indexing assigned by NLM MeSH Adenocarcinoma /economics /nursing /psychology /radiotherapy; Adult; Aged; Aged, 80 and over; Algorithms; Carcinoma, Transitional Cell /economics /nursing /psychology /radiotherapy; Cost-Benefit Analysis; Drug Costs; Follow-Up Studies; Great Britain; Hospital Costs; Humans; Male; Middle Aged; Nursing Assessment; Patient Compliance; Patient Satisfaction; Prostatic Neoplasms /economics /nursing /psychology /radiotherapy; Quality of Life; Radiation Injuries /epidemiology /etiology /nursing /psychology; Radiotherapy, Conformal /adverse effects /economics /nursing; Radiotherapy, High-Energy /adverse effects /economics /nursing; Urinary Bladder Neoplasms /economics /nursing /psychology /radiotherapy AccessionNumber 22002000306 Date bibliographic record published 31/05/2004 Date abstract record published 31/05/2004 |
|
|
|