Biomedical subjects

Andrea Manca

Publications and source records attributed to Andrea Manca.

13 recordsLinked to original sources

PubMed2006

Randomized trial of a brief physiotherapy intervention compared with usual physiotherapy for neck pain patients: cost-effectiveness analysis.

OBJECTIVES: To assess the cost-effectiveness of brief physiotherapy intervention versus usual physiotherapy management in patients with neck pain of musculoskeletal origin in the community setting. METHODS: A cost-effectiveness analysis was conducted alongside a multicenter pragmatic randomized controlled clinical trial. Individuals 18 years of age and older with neck pain of more than 2 weeks were recruited from physiotherapy departments with referrals from general practitioners (GPs) in the East Yorkshire and North Lincolnshire regions in the United Kingdom. A total of 139 patients were allocated to the brief intervention, and 129 to the usual physiotherapy. Resource use data were prospectively collected on the number of physiotherapy sessions, hospital stay, specialist, and GP visits. Quality-adjusted life years (QALYs) were estimated using EQ-5D data collected at baseline, 3 and 12 months from the start of the treatment. The economic evaluation was conducted from the U.K. National Health System perspective. RESULTS: On average, brief intervention produced lower costs (pounds--68; 95 percent confidence interval [CI], pounds--103 to pounds--35) and marginally lower QALYs (-0.001; 95 percent CI, -0.030 to 0.028) compared with usual physiotherapy, resulting in an incremental cost per QALY of pounds 68,000 for usual physiotherapy. These results are sensitive to patients' treatment preferences. CONCLUSIONS: Usual physiotherapy may not be good value for money for the average individual in this trial but could be a cost-effective strategy for those who are indifferent toward which treatment they receive.

Cost-Benefit Analysis↗

PubMed2006

'Lost in translation': accounting for between-country differences in the analysis of multinational cost-effectiveness data.

Cost-effectiveness analysis has gained status over the last 15 years as an important tool for assisting resource allocation decisions in a budget-limited environment such as healthcare. Randomised (multicentre) multinational controlled trials are often the main vehicle for collecting primary patient-level information on resource use, cost and clinical effectiveness associated with alternative treatment strategies. However, trial-wide cost effectiveness results may not be directly applicable to any one of the countries that participate in a multinational trial, requiring some form of additional modelling to customise the results to the country of interest. This article proposes an algorithm to assist with the choice of the appropriate analytical strategy when facing the task of adapting the study results from one country to another. The algorithm considers different scenarios characterised by: (a) whether the country of interest participated in the trial; and (b) whether individual patient-level data (IPD) from the trial are available. The analytical options available range from the use of regression-based techniques to the application of decision-analytic models. Decision models are typically used when the evidence base is available exclusively in summary format whereas regression-based methods are used mainly when the country of interest actively recruited patients into the trial and there is access to IPD (or at least country-specific summary data). Whichever method is used to reflect between-country variability in cost-effectiveness data, it is important to be transparent regarding the assumptions made in the analysis and (where possible) assess their impact on the study results.

Cost-Benefit Analysis↗

PubMed2006

Assessing generalisability in model-based economic evaluation studies: a structured review in osteoporosis.

To support decision making, many countries have now introduced some formal assessment process to evaluate whether health technologies represent good 'value for money'. These often take the form of decision models that can be used to explore elements of importance to generalisability of study results across clinical settings and jurisdictions. The objective of this review was to assess whether articles reporting decision-analytic models in the area of osteoporosis provided enough information to enable decision makers in different countries/jurisdictions to fully appreciate the variability of results according to location and be able to apply the evaluation to their own setting. Of the 18 articles included in the review, only three explicitly stated the decision-making audience. It was not possible to infer a decision-making audience in eight studies. The target population was well reported, as were resource and cost data, and clinical data used for estimates of relative risk reduction. However, baseline risk was rarely adapted to the relevant jurisdiction, and when no decision maker was explicit it was difficult to assess whether the reported cost and resource use data were in fact relevant. A few studies used sensitivity analysis to explore elements of generalisability, such as compliance rates and baseline fracture risk rates, although such analyses were generally restricted to evaluating parameter uncertainty. This review found that variability in cost effectiveness across locations is addressed to a varying extent in modelling studies in the field of osteoporosis, limiting their use for decision makers across different locations. Transparency of reporting is expected to increase as methodology develops and decision makers publish 'reference case' type guidance.

Costs and Cost Analysis↗

PubMed2005

Regression methods for cost-effectiveness analysis with censored data.

A system of seemingly unrelated regression equations is proposed for prognostic factor adjustment and subgroup analysis when comparing two groups in a cost-effectiveness analysis with censored data. Because of the induced dependent censoring on costs and quality-adjusted survival, inverse probability weighting is employed for parameter estimation. The method is illustrated with data from two recent examples using both survival time and quality-adjusted survival time as the measures of effectiveness.

Amiodarone↗

PubMed2005

Assessing generalisability by location in trial-based cost-effectiveness analysis: the use of multilevel models.

Cost-effectiveness analysis (CEA) in health care is increasingly conducted alongside multicentre and multinational randomised controlled clinical trials (RCTs). The increased use of stochastic CEA is designed to account for between-patient sampling variability in cost-effectiveness data assuming that observations are independently distributed. However, between-location variability in cost-effectiveness may result if there is a hierarchical structure in the data; that is, if there is correlation in costs and outcomes between patients recruited in particular locations. This may be expected in multi-location trials given that centres and countries often differ in factors such as clinical practice, patient case-mix and the unit costs of delivering health care. A failure to acknowledge this feature may lead to misleading conclusions in a trial-based economic study. Multilevel modelling (MLM) is an analytical framework that can be used to handle hierarchical cost-effectiveness data. Using data from a recently conducted economic analysis, this paper shows how multilevel modelling can be used to obtain (a) more appropriate estimates of the population average incremental cost-effectiveness and associated standard errors compared to standard stochastic CEA; and (b) location-specific estimates of incremental cost-effectiveness which can be used to explore appropriately the variability between centres/countries of the cost-effectiveness results.

Cost-Benefit Analysis↗

PubMed2005

Estimating mean QALYs in trial-based cost-effectiveness analysis: the importance of controlling for baseline utility.

In trial-based cost-effectiveness analysis baseline mean utility values are invariably imbalanced between treatment arms. A patient's baseline utility is likely to be highly correlated with their quality-adjusted life-years (QALYs) over the follow-up period, not least because it typically contributes to the QALY calculation. Therefore, imbalance in baseline utility needs to be accounted for in the estimation of mean differential QALYs, and failure to control for this imbalance can result in a misleading incremental cost-effectiveness ratio. This paper discusses the approaches that have been used in the cost-effectiveness literature to estimate absolute and differential mean QALYs alongside randomised trials, and illustrates the implications of baseline mean utility imbalance for QALY calculation. Using data from a recently conducted trial-based cost-effectiveness study and a micro-simulation exercise, the relative performance of alternative estimators is compared, showing that widely used methods to calculate differential QALYs provide incorrect results in the presence of baseline mean utility imbalance regardless of whether these differences are formally statistically significant. It is demonstrated that multiple regression methods can be usefully applied to generate appropriate estimates of differential mean QALYs and an associated measure of sampling variability, while controlling for differences in baseline mean utility between treatment arms in the trial.

Cost-Benefit Analysis↗

PubMed2005

Handling missing data in patient-level cost-effectiveness analysis alongside randomised clinical trials.

BACKGROUND: Missing data are potentially an extensive problem in cost-effectiveness analyses conducted alongside randomised clinical trials, where prospective collection of both resource use and health outcome information is required. There are several possible reasons for the presence of incomplete records, and the validity of the analysis in the presence of data with missing values is dependent upon the mechanism generating the missing data phenomenon. In the past, the most commonly used methods for analysing datasets with incomplete observations were relatively ad hoc (e.g. case deletion, mean imputation) and suffered from potential limitations. Recently, several alternative and more sophisticated approaches (e.g. multiple imputation) have been proposed that attempt to correct the flaws of the simple imputation methods. OBJECTIVES: The objectives are to provide a concise and accessible description of the quantitative methods most commonly used in trial-based cost-effectiveness analysis for handling missing data, and also to demonstrate the potential impact of these alternative approaches on the cost-effectiveness results reported in two case studies. METHODS: Data from two recently conducted, trial-based economic evaluations are used to explore the sensitivity of the study results to the technique used to deal with incomplete observations. A statistical framework for representing the uncertainty in the alternative methods is outlined using an approach based on net benefits and cost-effectiveness acceptability curves. RESULTS: The case studies demonstrate the potential importance of the approach used to handle missing data. Although the analytical strategy did not appear to alter the results of one of the studies, the other case study showed that that the results of the cost-effectiveness analysis were sensitive to both the decision to impute and also the imputation strategy adopted. CONCLUSIONS: Analysts should be more explicit in reporting the analytical strategies applied in the presence of missing data. The use of a multiple imputation approach is recommended in the majority of cases, so as to adequately reflect the uncertainty in the study results due to the presence of missing data.

Bias↗

PubMed2005

Increasing the generalizability of economic evaluations: recommendations for the design, analysis, and reporting of studies.

OBJECTIVES: Health technology assessment (HTA) is increasingly an international activity, and HTA agencies collaborate to avoid unnecessary duplication of effort. However, the sharing of the results from HTAs raises questions about their generalizability; namely, are the results of an HTA undertaken in one country relevant to another? METHODS: This study presents recommendations for increasing the generalizability of economic evaluations. They represent an important component of HTAs and are commonly thought to have limited generalizability. RESULTS: Recommendations are given for studies using patient-level data (i.e., evaluations conducted alongside clinical trials) and for studies using decision analytic modeling. CONCLUSIONS: If implemented, the recommendations would increase the value for investments in HTA.

Cooperative Behavior↗

PubMed2004

Randomised trial of a brief physiotherapy intervention compared with usual physiotherapy for neck pain patients: outcomes and patients' preference.

OBJECTIVES: Firstly, to compare the effectiveness of a brief physiotherapy intervention with "usual" physiotherapy for patients with neck pain. Secondly, to evaluate the effect of patients' preferences on outcome. DESIGN: Non-inferiority randomised controlled trial eliciting preferences independently of randomisation. SETTING: Physiotherapy departments in a community setting in Yorkshire and north Lincolnshire. PARTICIPANTS: 268 patients (mean age 48 years) with subacute and chronic neck pain, who were referred by their general practitioner and randomly assigned to a brief physiotherapy intervention (one to three sessions) using cognitive behaviour principles to encourage self management and return to normal function or usual physiotherapy, at the discretion of the physiotherapist concerned. MAIN OUTCOME MEASURES: The Northwick Park neck pain questionnaire (NPQ), a specific measure of functional disability resulting from neck pain. Also, the short form 36 (SF-36) questionnaire, a generic, health related, quality of life measure; and the Tampa scale for kinesophobia, a measure of fear and avoidance of movement. RESULTS: At 12 months, patients allocated to usual physiotherapy had a small but significant improvement in NPQ scores compared with patients in the brief intervention group (mean difference 1.99, 95% confidence interval 0.45 to 3.52; P = 0.01). Although the result shows a significant inferiority of the intervention, the confidence interval shows that the effect could be in the non-inferiority range for the brief intervention (below 1.2 points of NPQ score). Patients who preferred the brief intervention and received this treatment had similar outcomes to patients receiving usual physiotherapy. CONCLUSIONS: Usual physiotherapy may be only marginally better than a brief physiotherapy intervention for neck pain. Patients with a preference for the brief intervention may do at least as well with this approach. Additional training for the physiotherapists in cognitive behaviour techniques might improve this approach further.

Adolescent↗

PubMed2004

Cost effectiveness analysis of laparoscopic hysterectomy compared with standard hysterectomy: results from a randomised trial.

OBJECTIVE: To assess the cost effectiveness of laparoscopic hysterectomy compared with conventional hysterectomy (abdominal or vaginal). DESIGN: Cost effectiveness analysis based on two parallel trials: laparoscopic (n = 324) compared with vaginal hysterectomy (n = 163); and laparoscopic (n = 573) compared with abdominal hysterectomy (n = 286). PARTICIPANTS: 1346 women requiring a hysterectomy for reasons other than malignancy. MAIN OUTCOME MEASURE: One year costs estimated from NHS perspective. Health outcomes expressed in terms of QALYs based on women's responses to the EQ-5D at baseline and at three points during up to 52 weeks' follow up. RESULTS: Laparoscopic hysterectomy cost an average of 401 pounds sterling (708 dollars; 571 euros) more (95% confidence interval 271 pounds sterling to 542 pounds sterling) than vaginal hysterectomy but produced little difference in mean QALYs (0.0015, -0.015 to 0.018). Mean differences in cost and QALYs generated an incremental cost per QALY gained of 267 333 pounds sterling (471 789 dollars; 380 437 euros). The probability that laparoscopic hysterectomy is cost effective was below 50% for a large range of values of willingness to pay for an additional QALY. Laparoscopic hysterectomy cost an average of 186 pounds sterling (328 dollars; 265 euros) more than abdominal hysterectomy, although 95% confidence intervals crossed zero (-26 pounds sterling to 375 pounds sterling); there was little difference in mean QALYs (0.007, -0.008 to 0.023), resulting in an incremental cost per QALY gained of 26 571 pounds sterling (46 893 dollars; 37 813 euros). If the NHS is willing to pay 30 000 pounds sterling for an additional QALY, the probability that laparoscopic hysterectomy is cost effective is 56%. CONCLUSIONS: Laparoscopic hysterectomy is not cost effective relative to vaginal hysterectomy. Its cost effectiveness relative to the abdominal procedure is finely balanced.

Cost-Benefit Analysis↗

PubMed2004

Calculation of quality adjusted life years in the published literature: a review of methodology and transparency.

Economic evaluations alongside randomised controlled trials (RCTs) are increasingly being designed to prospectively collect patient-specific resource use and preference-based health status (utility) data. This paper examines the ways in which preference-based health status (utility) data are used to generate quality adjusted life years (QALYs). A literature review was carried out which identified 23 published cost utility analyses suitable for inclusion. The methodology employed to calculate QALYs was not always consistent, as well as being poorly reported. The use of different methodologies in the calculation of QALYs may influence the magnitude and direction of results of evaluations. Analysts need to be consistent and fully transparent in the methodology chosen to calculate QALYs.

Cost-Benefit Analysis↗

PubMed2003

A cost-utility analysis of tension-free vaginal tape versus colposuspension for primary urodynamic stress incontinence.

OBJECTIVE: To assess the cost effectiveness of tension-free vaginal tape compared with open Burch colposuspension as a primary treatment for urodynamic stress incontinence. DESIGN: Cost-utility analysis alongside a multicentre randomised comparative trial. SETTING: Gynaecology or Urology departments in 14 centres in the UK and Ireland, including University-associated teaching hospitals and district general hospitals. POPULATION: Women with urodynamic stress incontinence. Exclusion criteria were: (1) detrusor overactivity; (2) major voiding problems; (3) prolapse; (4) previous surgery for incontinence or prolapse. METHODS: Resource use data were collected on all 344 patients in the trial, including length of hospital stay, time in theatre and management of complications; resource use was costed using UK unit costs at 1999-2000 prices. MAIN OUTCOME MEASURES: Health outcomes were expressed in terms of quality-adjusted life years (QALYs) between baseline and six months follow up, based on women's responses to the EQ-5D health questionnaire. RESULTS: Tension-free vaginal tape resulted in a mean cost saving of pound 243 (95% CI pound 341 to pound 201) compared with colposuspension. Differential mean QALYs per patient (tension-free vaginal tape - colposuspension) was 0.01 (95% CI -0.01 to 0.03). The probability of tension-free vaginal tape being, on average, less costly than colposuspension, was 100%, and the probability of tension-free vaginal tape being more cost effective than colposuspension was 94.6% if the decision-maker was willing to pay pound 30,000 per additional QALY. CONCLUSIONS: The results from this trial suggest that, over a post-operative period of six months, tension-free vaginal tape is a cost effective alternative to colposuspension. The results will need to be reassessed on the basis of longer follow up.

Cost-Benefit Analysis↗

PubMed2003

The use of decision models in mental health economic evaluation: challenges and opportunities.

A number of reasons have been suggested for the increased use of decision-analytic modelling in assessing the cost-effectiveness of mental health interventions: (1) the need to rapidly assess the value-for-money of new pharmaceuticals; (2) the short time horizon of clinical trials in mental health; (3) the lack of head-to-head comparisons between alternative treatment strategies; and (4) the necessity to generalise the study results. As simulation exercises become more widely accepted and used to inform policy making decisions, a trend towards more sophisticated modelling structures is starting to emerge. This paper undertakes a structured critical appraisal of cost-effectiveness modelling studies, using published examples relating to available drug treatments for schizophrenia and Alzheimer's disease (AD). The models identified display some methodological heterogeneity in terms of the choice of comparator, costing methodology, timeframe and perspective of the analysis, target population and model structure. The use of 'state-of-the-art' techniques, such as value-of-information analysis and probabilistic-sensitivity analysis has been somewhat limited. Health service researchers need to make sure that the best available techniques are employed to maximise the use of the information already available.

Cost-Benefit Analysis↗