Docetaxel with prednisone or prednisolone for the treatment of ...

consensus and, if necessary, a third reviewer was
consulted. The quality of the clinical effectiveness
studies was assessed according to criteria based on
CRD Report No. 4. 23 The quality of the costeffectiveness
studies was assessed according to a
checklist updated from that developed by
Drummond and colleagues. 24 This checklist
reflects the criteria for economic evaluation
detailed in the methodological guidance
developed by NICE. Full details of the quality
assessment strategy are reported in Appendix 4.
Methods of analysis/synthesis
Clinical effectiveness
Full data extraction and quality assessment have
been presented for each individual study of
clinical effectiveness. The possible effects of study
quality on the effectiveness data and review
findings are discussed. Data are reported
separately for each outcome measure.
Where sufficient data were available, treatment
effects are presented in the form of relative risk
(RR) or hazard ratio (HR), as appropriate,
together with corresponding 95% confidence
intervals (CIs). Time to event data (survival data)
are presented as HRs, which were estimated from
number of events and log-rank p-value or survival
curves where necessary, as described by Parmar
and colleagues. 25 Where RR estimates and
corresponding 95% CIs were not presented in the
original trial report, they have been calculated,
using the numbers of events relative to the
numbers analysed. The numbers analysed for
individual outcomes were conservatively assumed
to be equivalent to the numbers randomised to
receive treatment if this information was not
reported. In some cases, the data are also
presented in the form of Forest plots.
Two reviewers independently extracted the
necessary information and performed all
calculations of HRs and RRs to reduce the
possibility of error. Appendix 5 shows an example
of these calculations.
Data on response rate, HRQoL and pain were not
collected consistently by trialists. The use of
different definitions of response and different
measurement scales precludes the statistical
synthesis of these data.
Data on the following adverse events were
collected: haematological toxicity including
anaemia, thrombocytopenia, granulocytopenia
© Queen’s Printer and Controller of HMSO 2007. All rights reserved.
Health Technology Assessment 2007; Vol. 11: No. 2
and neutropenia and leucopenia and nonhaematological
toxicity including nausea,
vomiting, diarrhoea, stomatitis, myalgia, cardiac
toxicity, pulmonary toxicity, arthralgia, dyspnoea,
impaired left ventricular ejection fraction,
shortness of breath, thrombosis, asthenia,
headache, peripheral oedema, epistaxis, bone
pain, sensory or motor neuropathy, anorexia,
weight gain, change in taste, tearing, fatigue,
allergic reactions, fluid retention, alopecia, nail
and skin toxicities and any other adverse events
judged to be appropriate, such as infectionassociated
reactions. The most commonly
occurring adverse events are presented, where
possible, along with details of grade 3 or 4 adverse
events.
The small number of studies prevented the
assessment of publication bias using funnel plots
or the Egger test. 26 However, the risk is likely to
be low, considering the attempts to locate
unpublished data.
Cost-effectiveness
For the cost-effectiveness section of the report,
details of each identified published economic
evaluation, together with a critical appraisal of its
quality, are presented in structured tables. This
included studies based on patient-level data and
decision models and included any studies
provided by the manufacturers.
For analysis based on patient-level data, the
validity of the studies was assessed in terms of the
sources of resource use and effectiveness data, the
valuation methods used to cost the resource use
and value patient benefits, the methods of analysis
and the generalisability of results. For analysis
based on decision models, the critical appraisal
was based on a range of questions including:
● structure of model
● time horizon
● details of key input parameters and their
sources
● methods of analysis (e.g. handling uncertainty).
Handling the company submissions
No data additional to the publications identified
from the literature searches were presented in the
company submissions in terms of clinical
effectiveness, other than mean survival data
calculated for one of the included studies
(TAX 327).
The economic evaluations included in the
company submission were assessed. This included
9