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Ensor J, Riley RD, Jowett S, et al.; on behalf of the PIT-STOP collaborative group. Prediction of risk of recurrence of venous thromboembolism following treatment for a first unprovoked venous thromboembolism: systematic review, prognostic model and clinical decision rule, and economic evaluation. Southampton (UK): NIHR Journals Library; 2016 Feb. (Health Technology Assessment, No. 20.12.)

Cover of Prediction of risk of recurrence of venous thromboembolism following treatment for a first unprovoked venous thromboembolism: systematic review, prognostic model and clinical decision rule, and economic evaluation

Prediction of risk of recurrence of venous thromboembolism following treatment for a first unprovoked venous thromboembolism: systematic review, prognostic model and clinical decision rule, and economic evaluation.

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Appendix 2Inclusion/exclusion forms

Titles and abstracts inclusion/exclusions form

Title and/or abstract
IncludeExclude
Prognostic modelsPrognostic models
Study designRCTsNon-human studies
CohortCommentaries
Case–controlCase reports (single case reports)
Case seriesStudy design papers
LettersNon-systematic reviews
Systematic reviews (at least one database used)Cross-sectional
Conference abstracts (2005 onwards)Conference abstracts (pre 2005)
Unclear study designs
Modelling keywords‘model’ (e.g. prediction model)No mention of a ‘model’/’rule’/’score’/’prediction’/’index’/’algorithm’, etc.
‘rule’
‘score’ (e.g. risk/prediction score)
‘prediction’
‘index’
‘algorithm’
‘risk stratification’
‘adjustment for’
‘factors contribution to risk’
‘adjusted odds ratio/hazard ratio/relative risk’, etc.
PopulationMajority of patients aged ≥ 18 yearsPatients aged < 18 years
Patients with a first unprovoked VTE (unprovoked = no history of major surgery; lower limb trauma, e.g. fracture, cast, limping for 3 days; use of the combined OC pill or HRT; pregnancy; significant immobility, e.g. confined to bed for 3 days; cancer)Patients with a first provoked VTE (provoked = history of major surgery; lower limb trauma, e.g. fracture, cast, limping for 3 days; use of the combined OC pill or HRT; pregnancy; significant immobility, e.g. confined to bed for 3 days; cancer)
Patients must have received at least 3 months oral anticoagulation treatmentPatients not treated with OACs, or treated for less than 3 months
Mixed populations; only where data extractable for patients meeting above criteriaHealthy individuals, or with conditions other than those described under inclusion criteria (e.g. portal, mesenteric, cerebral vein thrombosis, etc.)
Prognostic modelPrognostic models utilising multiple prognostic variablesDoes not report prognostic models
OutcomeRecurrence of VTEOutcomes other than those mentioned in the inclusion criteria
Adverse outcomes including mortality and bleeding
Quality of life/cost-effectiveness
LinkAppears to (or could possibly) utilise model to predict risk of VTE recurrence or adverse outcomeClearly does not link prognostic models to VTE recurrence or adverse outcomes

Full-text inclusion/exclusion form

CriteriaYesC/TNoPrognostic model
Reviews and discussionsDoes the study do more than just discuss a model
PopulationAre patients at least 18 years old
Could the population or a defined subpopulation be considered as unprovoked (if not why not)
Can we identify results specifically for the unprovoked population
Did patients receive at least 3 months treatment with either a vitamin K antagonist or an OAC
OutcomeDoes the model predict least one of: recurrence/mortality/bleeding/quality of life
ModelsDoes the model aim to do more than assess a single factor adjusted for other things
Is the model used to predict individuals risk of one of the above outcomes
Decision
Exclude with reason
Does the study include an economic evaluation of a model?
Comments
If includedYesC/TNoFactors
If the study is included, what is their definition of unprovoked?Major surgery
Lower limb trauma
Use of OC pill or HRT
Pregnancy
Significant immobility
Cancer
Thrombophillia (e.g. antiphosphlipid syndrome, factor V leiden, etc.)

C/T, can’t tell.

Notes

Unprovoked = no history (within 3 months) of major surgery; lower limb trauma, e.g. fracture, cast; use of the combined OC pill or HRT; pregnancy; significant immobility, e.g. confined to bed for 3 days; cancer.

A ‘yes’ in all categories under criteria indicates to include a study, any ‘no’ responses indicate exclusion.

Copyright © Queen’s Printer and Controller of HMSO 2016. This work was produced by Ensor et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.

Included under terms of UK Non-commercial Government License.

Bookshelf ID: NBK344090
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