M.J. Calvert

Cardiac resynchronisation for patients with heart failure due to left ventricular systolic dysfunction — a systematic review and meta-analysis

Randomised controlled trials generally suggest that cardiac resynchronisation improves outcomes in patients with heart failure due to left ventricular systolic dysfunction and cardiac dyssynchrony. Our objective was to provide a valid synthesis of the effects of CRT on mortality, major morbidity, quality of life and implantation success rates.

Use of health‐related quality of life in prescribing research. Part 1: why evaluate health‐related quality of life?

Clinicians, regulatory authorities, and pharmaceutical companies increasingly recognize the importance of assessing the patients perspective on the impact of disease and its treatment on their health‐related quality of life (HRQoL). This article describes the importance of assessing HRQoL, particularly in patients with chronic disease, provides examples of the different types of instrument available for measuring HRQoL and considers how such assessment can aid medical‐decision making. In addition we consider the potential role of HRQoL assessment in routine clinical practice, and its use in licensing and health technology appraisal.

Composite and surrogate outcomes in randomised controlled trials

Composite end points may mislead—and regulators allow it to happen

What factors predict differences in infant and perinatal mortality in primary care trusts in England? A prognostic model

Objective To identify predictors of perinatal and infant mortality variations between primary care trusts (PCTs) and identify outlier trusts where outcomes were worse than expected. Design Prognostic multivariable mixed models attempting to explain observed variability between PCTs in perinatal and infant mortality. We used these predictive models to identify PCTs with higher than expected rates of either outcome. Setting All primary care trusts in England. Population For each PCT, data on the number of infant and perinatal deaths, ethnicity, deprivation, maternal age, PCT spending on maternal services, and “Spearhead” status. Main outcome measures Rates of perinatal and infant mortality across PCTs. Results The final models for infant mortality and perinatal mortality included measures of deprivation, ethnicity, and maternal age. The final model for infant mortality explained 70% of the observed heterogeneity in outcome between PCTs. The final model for perinatal mortality explained 80.5% of the between-PCT heterogeneity. PCT spending on maternal services did not explain differences in observed events. Two PCTs had higher than expected rates of perinatal mortality. Conclusions Social deprivation, ethnicity, and maternal age are important predictors of infant and perinatal mortality. Spearhead PCTs are performing in line with expectations given their levels of deprivation, ethnicity, and maternal age. Higher spending on maternity services using the current configuration of services may not reduce rates of infant and perinatal mortality.

Use of health-related quality of life in prescribing research. Part 2: methodological considerations for the assessment of health-related quality of life in clinical trials

This article aims to address key methodological issues that should be considered when assessing health‐related quality of life (HRQoL) in a clinical trial. These include justification for the selection of HRQoL as a primary or secondary outcome and choice of an appropriate instrument to assess HRQoL, which meets basic psychometric properties. In addition we consider ways to minimize bias within the trial through optimization of compliance and timing of assessments.

Cost effectiveness of cardiac resynchronization therapy in the Nordic region: An analysis based on the CARE‐HF trial

The aim of this study was to investigate the cost‐effectiveness of cardiac resynchronization therapy (CRT) in Denmark, Finland and Sweden. The analysis was based on the CARE‐HF trial, a randomised clinical trial investigating the efficacy of adding CRT (n=409) to optimal pharmacological treatment (n=404) in patients with moderate to severe heart failure with markers of cardiac dyssynchrony. The average follow‐up time was 29.4 months.

An introduction to patient-reported outcome measures in ophthalmic research.

Clinical outcomes, such as quantifying the extent of visual field loss by automated perimetry, are valued highly by health professionals, but such measures do not capture the impact of the condition on a patient’s life. Patient-reported outcomes describe any report or measure of health reported by the patient, without external interpretation by a clinician or researcher. In this review, we discuss the value of the measures that capture this information (patient-reported outcome measures; PROMs), and why they are important to both the clinician and the researcher. We also consider issues around developing or selecting a PROM for ophthalmic research, the emerging challenges around conducting and reporting PROMs in clinical trials and highlight best practice for their use. Search terms for this review comprised: (1) (patient-reported outcomes OR patient-reported outcome measures) AND (2) randomised controlled trials AND (3) limited to ophthalmic conditions. These terms were expanded as follows: (((‘patients’(MeSH Terms) OR ‘patients’(All Fields) OR ‘patient’(All Fields)) AND (‘research report’(MeSH Terms) OR (‘research’(All Fields) AND ‘report’(All Fields)) OR ‘research report’(All Fields) OR ‘reported’(All Fields)) AND outcomes(All Fields)) OR ((‘patients’(MeSH Terms) OR ‘patients’(All Fields) OR ‘patient’(All Fields)) AND (‘research report’(MeSH Terms) OR (‘research’(All Fields) AND ‘report’(All Fields)) OR ‘research report’(All Fields) OR ‘reported’(All Fields) AND (‘outcome assessment (health care)’(MeSH Terms) OR (‘outcome’(All Fields) AND ‘assessment’(All Fields) AND ‘(health’(All Fields) AND ‘care)’(All Fields)) OR ‘outcome assessment (health care)’(All Fields) OR (‘outcome’(All Fields) AND ‘measures’(All Fields)) OR ‘outcome measures’(All Fields)))) AND (‘randomized controlled trial’(Publication Type) OR ‘randomized controlled trials as topic’(MeSH Terms) OR ‘randomised controlled trials’(All Fields) OR ‘randomized controlled trials’(All Fields)) AND (ophth*(All Fields)). The authors also utilised the extensive non-ophthalmic literature and online resources relating to PROs and PROMs to inform this review.

Oseltamivir: the real world data

To coincide with the publication of an updated systematic review by the Cochrane group the BMJ invited Nick Freemantle and colleagues to consider the current status of observational studies of oseltamivir and their influence on policy and practice

What can we learn from observational studies of oseltamivir to treat influenza in healthy adults

Post-marketing studies can provide important information about safety and efficacy in real practice. However, Nick Freemantle and Mel Calvert found studies of oseltamivir identified by Roche were of limited value

Cost effectiveness of cardiac resynchronization therapy in Greece: an analysis based on the CArdiac REsychronization in Heart Failure trial

AIMS Health economic considerations have become increasingly important in healthcare. The aim of this study was to investigate the incremental cost effectiveness of cardiac resynchronization therapy (CRT) plus medical therapy compared with medical therapy alone in the Greek health-care system. METHODS AND RESULTS The health economic analysis was based on the CARE-HF trial, a randomized clinical trial estimating the efficacy of adding CRT (n = 409) to optimal pharmacological treatment (n = 404) in patients with moderate-to-severe heart failure with markers of cardiac dyssynchrony. Health care resource use from CArdiac REsychronization in Heart Failure was combined with costs for CRT implantation and hospitalization from publicly available sources. The analysis was based on a lifetime perspective, with the life expectancy estimated from the clinical trial data. Shorter time horizons were explored in the sensitivity analysis. The cost per quality-adjusted life year (QALY) gained with CRT was €6,045 in Greece, with a 95% confidence interval for the cost-effectiveness ratio of €4,292-9,411 per QALY gained. CONCLUSIONS The results of the economic evaluation of CRT in Greek health-care setting indicate that it is a cost-effective treatment compared with traditional pharmacological therapy. Cardiac resynchronization therapy can therefore be recommended for routine use in patients with moderate-to-severe heart failure and markers of dyssynchrony.