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Table 2 Eligibility criteria

From: UMBRELLA protocol: systematic reviews of multivariable biomarker prognostic models developed to predict clinical outcomes in patients with heart failure

Criteria

Type of studies

Target population

Inclusion

We will include only primary clinical studies in HF with clinical models and/or outcomes that present:

- Prognostic model development, adjustment or updating with or without external validation. The model’s discrimination and/or calibration must have been reported.

- External model validation. The model’s discrimination and/or calibration must have been reported. The source of data could be medical records, existing RCT data, or large clinical databases.

Adult patients aged 18 or older, diagnosed with any type of HF (i.e. ischaemic, non-ischaemic, chronic, acute, or decompensated). Patients with both reduced and preserved ejection fraction HF are eligible for inclusion. Those patients may or may not have already received optimum medical therapy (OMT), including medications and implantable devices (e.g. implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy (CRT) devices).

Exclusion

- Studies using exclusively assay analyses.

- Studies published only as abstracts or clinical trials reporting no prognostic modelling on HF patients.

- Studies developing models with the sole intention of evaluating the independent or adjusted association of a factor (even if this is a biomarker) with the outcome and not to predict individual probabilities.

- Studies that explore the prognostic effect of treatment (eg. medication regimes, device implantation, etc.)

- Systematic reviews, unless authors use a review to form a data repository for developing a prognostic model.. Their citation list will be explored for further inclusion of primary studies potentially missed by our sensitive search.

- Literature reviews.

- Case studies.

- Diagnostic studies.

- Studies focusing on economic evaluations of HF care.

- Patients who are recipients or already registered candidates for transplantation, left (LVAD), or biventricular (BiVAD) assist devices as their HF status will be significantly altered by this intervention.

- Patients with advanced/end stage HF (e.g. NYHA IV) and those receiving end of life or palliative care, or who also suffer from HF as a comorbidity will not be considered because of their already established poor prognosis.

- Patients with HF due to congenital conditions, and secondary to reversible causes (such as valvular disease, pregnancy and peripartum, infection, major surgery, pre-revascularisation, intensive care conditions).

- Patients with concomitant disease which predominantly affects prognosis, such as cancer and neurological disorders.