NICE guidance in schizophrenia: how generalisable are drug trials?

Burns, Tom

doi:10.1192/pb.30.6.210

Cited by 3 publications

(2 citation statements)

References 9 publications

(5 reference statements)

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“…Whether clinically significant selection bias occurs during recruitment to clinical trials is contentious. Although Burns (2006) reported that the basic demography of patients in a large naturalistic study was similar to that of a widely reported RCT, other authors have noted that the more chaotic patient who is difficult to manage will not be entered into a clinical trial as, even if they consent, they will undoubtedly drop out of follow-up (Lester & Wilson, 1999; Harrison-Read et al , 2002). Trials rarely report the number of patients considered or screened for a trial who are never included.…”

Section: Randomised Controlled Trialsmentioning

confidence: 93%

Measurement of long-term outcomes in observational and randomised controlled trials

Hodgson¹,

Bushe

Hunter

2007

Br J Psychiatry

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BackgroundRandomised controlled trials (RCTs) are the gold standard for evaluating treatment efficacy. However, the outcomes of RCTs often lackclinical utility and usually do not address real-world effectivenessAimsTo review how traditional RCTs may be triangulatedwith other methodologies such as observational studies and pragmatic trials by highlighting recently reported studies, outcomes used and their respective meritsMethodLiterature review focusing on drug treatmentResultsRecently reported observational and some pragmatic studies show a degree of consistency in reported results and use outcomes that have face validity for cliniciansConclusionsNo single experimental paradigm or outcome provides the necessary data to optimise treatment of mental illness in the clinical setting

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Section: Randomised Controlled Trialsmentioning

confidence: 93%

Measurement of long-term outcomes in observational and randomised controlled trials

Hodgson¹,

Bushe

Hunter

2007

Br J Psychiatry

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“…However, this is achieved by purposive sampling rather than quantitative ranking against a specific measure such as socio‐economic deprivation. Patients’ demographic and illness characteristics are not that different from those routinely described in drug trials (8, 13) – young middle aged, an excess of males with illness histories of up to 20 years (14). They were, however, slightly less symptomatic than those routinely recruited into drug trials (e.g.…”

Section: Discussionmentioning

confidence: 99%

Maintenance antipsychotic medication patterns in outpatient schizophrenia patients: a naturalistic cohort study

Burns

Christova²,

Cooper

et al. 2005

Acta Psychiatr Scand

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Representativeness of the dabigatran, apixaban and rivaroxaban clinical trial populations to real-world atrial fibrillation patients in the United Kingdom: a cross-sectional analysis using the General Practice Research Database

et al. 2012

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ObjectiveThree oral anticoagulants have reported study results for stroke prevention in patients with atrial fibrillation (AF) (dabigatran etexilate, rivaroxaban and apixaban); all demonstrated superiority or non-inferiority compared with warfarin (RE-LY, ARISTOTLE and ROCKET-AF). This study aimed to assess the representativeness for the real-world AF population, particularly the population eligible for anticoagulants.DesignA cross-sectional database analysis.SettingDataset derived from the General Practice Research Database (GPRD).Primary and secondary outcomes measureThe proportion of real-world patients with AF who met the inclusion/exclusion criteria for RE-LY, ARISTOTLE and ROCKET-AF were compared. The results were then stratified by risk of stroke using CHADS2 and CHA2DS2-VASc.Results83 898 patients with AF were identified in the GPRD. For the population at intermediate or high risk of stroke and eligible for anticoagulant treatment (CHA2DS2-VASc ≥1; n=78 783 (94%)), the proportion eligible for inclusion into RE-LY (dabigatran etexilate) was 68% (95% CI 67.7% to 68.3%; n=53 640), compared with 65% (95% CI 64.7% to 65.3%; n=51 163) eligible for ARISTOTLE (apixaban) and 51% (95% CI 50.7% to 51.4%; n=39 892) eligible for ROCKET-AF (rivaroxaban). Using the CHADS2 method of risk stratification, for the population at intermediate or high risk of stroke and eligible for anticoagulation treatment (CHADS2 ≥1; n=71 493 (85%)), the proportion eligible for inclusion into RE-LY was 74% (95% CI 73.7% to 74.3%; n=52 783), compared with 72% (95% CI 71.7% to 72.3%; n=51 415) for ARISTOTLE and 56% (95% CI 55.6% to 56.4%; n=39 892) for ROCKET-AF.ConclusionsPatients enrolled within RE-LY and ARISTOTLE were more reflective of the ‘real-world’ AF population in the UK, in contrast with patients enrolled within ROCKET-AF who were a more narrowly defined group of patients at higher risk of stroke. Differences between trials should be taken into account when considering the applicability of findings from randomised clinical trials. However, assessing representativeness is not a substitute for assessing generalisibility, that is, how well clinical trial results would translate into effectiveness and safety in everyday routine care.

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NICE guidance in schizophrenia: how generalisable are drug trials?

Cited by 3 publications

References 9 publications

Measurement of long-term outcomes in observational and randomised controlled trials

Measurement of long-term outcomes in observational and randomised controlled trials

Maintenance antipsychotic medication patterns in outpatient schizophrenia patients: a naturalistic cohort study

Representativeness of the dabigatran, apixaban and rivaroxaban clinical trial populations to real-world atrial fibrillation patients in the United Kingdom: a cross-sectional analysis using the General Practice Research Database

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