Measuring health-related quality of life in diabetic peripheral neuropathy: a systematic review.

We undertook a systematic review of disease-specific measures of health-related quality of life (HRQL) in diabetic peripheral neuropathy (DPN) to appraise the scientific (psychometric) evidence and make recommendations about the best instrument(s) to use. DPN is a common complication of diabetes mellitus. A need to consider the broad impact of DPN, rather than just pain and the increasingly recognised need to assess patient-reported outcomes such as HRQL in evaluating healthcare has led to a demand for rigorous outcome measures. To identify appropriate disease-specific measures, we searched four databases: PubMed, Embase, PsycINFO and CINAHL Plus. Data were extracted from each article using a standard data extraction form and the psychometric properties of each HRQL measure were reviewed. We identified three DPN-specific measures of HRQL: PN-QOL-97, Norfolk QOL-DN, NeuroQoL. All three measures satisfy at least one criterion for both reliability and validity, though all also have some disadvantages. Where there is no requirement for multi-language versions, the PN-QOL-97 is a useful instrument. Studies that involve multiple languages would need to use the shorter QOL-DN but would also need to incorporate complementary instruments to address the psychological and emotional impact of DPN.

Eliciting health state utilities from the general public for severe chronic pain.

OBJECTIVE: There is an absence of data on public preferences for health states (HSs) associated with severe chronic pain. The aim of this study was to develop accurate HS descriptions for severe chronic pain requiring intrathecal (IT) therapy and to derive utility weights that describe the health-related quality of life (HRQL) impact of chronic pain associated with malignant (MP) and non-malignant (NMP) aetiologies. RESEARCH DESIGN AND METHOD: Eight visual analogue scale pain index (VAS-PI) HSs were defined using ranges 0-40, 41-60, 61-80 and 81-100 applied to both MP and NMP. Additionally, eight HSs representing common adverse events associated with IT therapy were identified. The content and description of the HSs were ascertained by interviews with five United Kingdom clinical experts. In total, 16 HSs were compiled. These HS descriptions and HS questionnaires were administered to 102 members of the public, utilising a time trade off (TTO) approach to estimate utilities for the HSs. RESULTS: Participants generally were well matched to the general public in England and Wales, with some differences in mean age, race and education. A substantial decline in utility was observed with more severe VAS-PI values. The mean TTO utility values also decreased from mild pain to severe pain. Participants were able to differentiate between the side effects. CONCLUSION: The study shows a clear decrement in utility moving from different severity levels of severe chronic pain.

Cost-effectiveness of ziconotide in intrathecal pain management for severe chronic pain patients in the UK.

OBJECTIVE: To examine the cost-effectiveness of using intrathecal ziconotide in the treatment of severe chronic pain compared to best supportive care for patients with intractable chronic pain in the United Kingdom. METHODS: Using a simulation model, the analysis evaluated the cost and health economic consequences of using ziconotide as a treatment for severe chronic pain. The modelled population and clinical data were based on a randomised controlled trial in which the main outcome was reduction in pain as measured by the visual analogue scale of pain intensity (VASPI). Resource use data were elicited using a modified Delphi panel and costed using published sources. Utility values were derived from a separate research study. The main outcome measure was the cost per quality-adjusted life-year (QALY). Extensive scenario analysis was conducted to evaluate parameter uncertainty. RESULTS: Overall, findings were robust to most assumptions. The cost-effectiveness of ziconotide compared to best supportive care (BSC) was pound 27,443 per QALY (95% CI pound 18,304-38,504). Scenarios were investigated in which discount rates, the time horizon, the threshold for qualifying as a responder, pump-related assumptions, utilities, ziconotide drug dose, and the patient discontinuation rate with ziconotide were varied. The most sensitive parameter was the dosage of ziconotide: using the lower and upper bounds of the average ziconotide dosage observed in the long-term open-label study changed the incremental cost-effectiveness ratio (ICER) to pound 15,500 [pound 8206-25,405] and pound 44,700 [pound 30,541-62, 670]. CONCLUSIONS: Ziconotide may offer an economically feasible alternative solution for patients for whom current treatment is inappropriate or ineffective. The main study limitation is that some model inputs, mainly related to resource use, are based on assumptions or expert interviews.

Cost-effectiveness of acarbose for the management of impaired glucose tolerance in Sweden.

We assessed the cost-effectiveness of acarbose in the management of patients with impaired glucose tolerance (IGT) in Sweden, based on progression to type 2 diabetes (T2D) and cardiovascular (CV) events reported in the STOP-NIDDM trial population, including high-risk subgroups. The cost per patient free from T2D was SEK28,000 or SEK1260 per diabetes free month prior to progression to T2D. The cost per patient free from CV events was SEK101,000 or SEK5000 per CV event free month. For the high CV risk subgroups, acarbose treatment dominated placebo (i.e. acarbose was more effective, less costly). Acarbose significantly reduces the incidence of diabetes and CV events in IGT patients. We predict this may translate into healthcare cost savings that partially or, in patients at high CV risk, fully offset the cost of acarbose. We conclude that acarbose is likely to be cost-effective in the management of impaired glucose tolerance.

A cost-effectiveness model of alternative statins to achieve target LDL-cholesterol levels.

An economic model was developed to estimate the relative cost-effectiveness of alternative HMG-CoA reductase inhibitors (statins)--atorvastatin, cerivastatin, fluvastatin, pravastatin and simvastatin--to achieve target low-density lipoprotein cholesterol (LDL-C) levels in a population of secondary CHD prevention patients. By using a cholesterol target as the endpoint of interest and a dose titration approach, the model assumes that the statins demonstrate a class effect through cholesterol lowering. The model was used to estimate the proportion of patients achieving target LDL-C levels (< 3 mmol/l) under each scenario tested. Total costs and incremental cost-effectiveness relative to no treatment and to the lowest cost option were estimated for each scenario. Total costs were highest for pravastatin and lowest for cerivastatin. Compared with no treatment, the incremental cost per patient treated to target LDL-C varied between 383 Pounds (atorvastatin) and 1213 Pounds (pravastatin). Incremental cost-effectiveness ratios in comparison with the lowest cost treatment (cerivastatin) were 141 Pounds per additional patient achieving target LDL-C with atorvastatin, and 275 Pounds with simvastatin. Fluvastatin and pravastatin were both less effective and more expensive than the lowest cost therapy. Although cerivastatin was associated with lowest expected costs, therapy with atorvastatin achieved the lowest cost-effectiveness ratios. Hence atorvastatin would allow the largest number of patients to be treated to target LDL-C within a fixed drug budget. Choosing between drug therapies on the basis of price alone may be misleading if the effectiveness of therapies varies.

Valaciclovir prophylaxis of cytomegalovirus infection and disease in renal transplantation: an economic evaluation.

BACKGROUND: Cytomegalovirus (CMV) disease is a major cause of morbidity and mortality in solid organ transplant patients and is associated with large additional healthcare expenditures. An economic evaluation of valaciclovir CMV prophylaxis in a renal transplant population is reported. METHODS: Medical resource use data were collected alongside a multicenter multinational randomized, placebo-controlled, double-blind trial of valaciclovir CMV prophylaxis in renal transplantation. Patients were stratified into donor seropositive/recipient sero-negative (D+R-) and recipient seropositive (R+) groups. Patients were followed-up 6 months posttransplant. A cost-effectiveness analysis from the perspective of the French health care system was performed using the number of cases of CMV disease avoided at 6 months as the clinical endpoint. RESULTS: Resource use was significantly increased among patients who developed CMV disease compared to those who did not develop disease. In the high risk D+R- group, valaciclovir prophylaxis was associated with an average of 5.5 fewer inpatient hospital days (P < OR =0.05) and with significantly lower use of other healthcare resources. In the R+ group, valaciclovir prophylaxis prevented cases of CMV disease at a marginally greater mean cost per patient compared with placebo. For D+R- patients valaciclovir prophylaxis was therefore an economically superior strategy, resulting in fewer cases of CMV disease and lower total mean healthcare expenditures. CONCLUSIONS: Valaciclovir CMV prophylaxis in renal transplantation is a more cost-effective therapy compared with placebo, in the high-risk D+R- patient population. For the R+ group, the incremental cost per case of CMV disease was modest.

Assessing patient outcomes in acute exacerbations of chronic bronchitis: the measure your medical outcome profile (MYMOP), medical outcomes study 6-item general health survey (MOS-6A) and EuroQol (EQ-5D).

There is little published information on the measurement of health status or quality of life in acute exacerbations of chronic bronchitis. The measure yourself medical outcome profile (MYMOP), the medical outcomes study 6-item general health survey (MOS-6A), and EuroQoL (EQ-5D) were evaluated in 81 patients with acute exacerbations of Type-1 chronic bronchitis presenting at a single general practice centre in Glasgow. The questionnaires were administered at the first clinic visit and at a second visit within 1 week of treatment completion. Item scores for MYMOP were generally more responsive than those for the other instruments, as assessed by standardised response means and an index of responsiveness for those patients reporting minimal change between visits. Construct validity was demonstrated for the MYMOP by the gradient in score change with the patient's perceived change in clinical condition and by the relationship between score change and the physician's assessment of clinical outcome. This study demonstrated that the MYMOP is a valid and potentially useful instrument for the assessment of patient outcomes in acute exacerbations of chronic bronchitis and is more responsive than the MOS-6A or EQ-5D in this setting. The choice of instrument will vary according to the objective of the study.

Cost-effectiveness model of cytomegalovirus management strategies in renal transplantation. Comparing valaciclovir prophylaxis with current practice.

BACKGROUND: Cytomegalovirus (CMV) disease may occur following renal transplantation and has been shown to have health and cost consequences in this setting. OBJECTIVE: To compare the cost effectiveness of different CMV management strategies for renal transplant patients: prophylaxis with (i) oral valaciclovir or (ii) intravenous ganciclovir; viral testing for CMV followed by (iii) pre-emptive therapy with intravenous ganciclovir or (iv) adjustment of immunosuppression and intensive monitoring; or (v) waiting to treat when CMV disease develops. METHODS: A decision-tree model was constructed that included the different management strategies for the donor seropositive/recipient seronegative (D+R-) population. Clinical outcomes for the D+R- population came from clinical trials. Treatment algorithms and costs for CMV syndrome and tissue invasive disease were developed from published literature and UK physician interviews. One- and 2-way sensitivity analyses were performed. STUDY PERSPECTIVE: UK National Health Service. RESULTS: Prophylaxis with either oral valaciclovir or intravenous ganciclovir dominated (lower costs and fewer cases of CMV disease) the pre-emptive treatment and wait-and-treat strategies. The cost per patient was from 157 Pounds to 438 Pounds higher with oral valaciclovir prophylaxis compared with intravenous ganciclovir prophylaxis and the incremental cost per case of CMV disease avoided with valaciclovir prophylaxis ranged from 2243 Pounds to 8111 Pounds (1996 values). These results are sensitive to the efficacy of intravenous ganciclovir prophylaxis and CMV management costs. CONCLUSIONS: For D+R- renal transplant patients, prophylaxis is the dominant (more effective and less costly) management strategy compared with pre-emptive and wait-and-treat strategies. The cost per patient with oral valaciclovir prophylaxis compared with intravenous ganciclovir prophylaxis is slightly higher in our base case scenario, but may be lower under reasonable alternative assumptions.

A comparison of death certificates and autopsies in the Australian Capital Territory.

OBJECTIVE: To determine the accuracy of death certificates in the Australian Capital Territory (ACT) by comparison with autopsy reports. DESIGN: A retrospective study of 495 deaths occurring from 1979 to 1987, excluding coronial deaths and deaths of infants under one year of age. The main cause of death on the death certificate was compared with the main cause of death recorded on an autopsy-supported death certificate created for the study. SETTING: The deaths occurred in both major institutional hospitals in the ACT. These hospitals are government-funded and administered, catering for both private and public patients. PATIENTS: There were 495 autopsies recorded in the ACT over the study period. The age data were lost in two cases. MAIN OUTCOME MEASURES: To find a simple measure of death certificate accuracy and compare the results with previous work. RESULTS: The accuracy of death certificates was 77%. Age, sex and length of hospital stay made little difference to the accuracy. Neoplastic diseases were accurately reported in 90% of cases, digestive and cardiovascular diseases in 81%. CONCLUSIONS: There is a need for practical methods and standard criteria to evaluate accuracy of death certificates.