| Study characteristics |
| Patient Sampling |
103 consecutive patients with anaemia (Hb <= 13 gr/dL in men and Hgb < =12 gr/dL), and advanced heart failure. No further details about the sampling procedure were given. |
| Patient characteristics and setting |
Adults patients (both sexes) with anaemia and heart failure attending the Alexandra University Hospital in Athens, Greece. |
| Index tests |
A serum ferritin concentration lower than 150.5 µg/L was classified as iron deficiency (no further details about the SF measurement approach were given). |
| Target condition and reference standard(s) |
Assessment of iron stores in bone marrow where absence of iron in smears was classified as iron deficiency (no further details about the measurement approach or grading scale were given). |
| Flow and timing |
Haematologic and biochemical analyses (such as serum ferritin), bone marrow aspiration measurements, and reviews of medical records were undertaken. However, the flow and timing of these three types of tests were not described. |
| Comparative |
|
| Notes |
ROC analysis showed that ferritin < 150.5 µg/L diagnosed iron deficiency with a sensitivity of 81.3%,and specificity of 76.9% (PPV = 85.7%). An algorithm based exclusively on an easily obtainable laboratory test can provide rapid, practical but valid diagnostic evaluation of iron deficiency in anaemic patients with heart failure and thus facilitate treatment selection in everyday clinical practice. |
| Methodological quality |
| Item |
Authors' judgement |
Risk of bias |
Applicability concerns |
| DOMAIN 1: Patient Selection |
| Was a consecutive or random sample of patients enrolled? |
Yes |
|
|
| Was a case‐control design avoided? |
Unclear |
|
|
| Did the study avoid inappropriate exclusions? |
Unclear |
|
|
| Could the selection of patients have introduced bias? |
|
Unclear risk |
|
| Are there concerns that the included patients and setting do not match the review question? |
|
|
Low concern |
| DOMAIN 2: Index Test (All tests) |
| Were the index test results interpreted without knowledge of the results of the reference standard? |
Unclear |
|
|
| If a threshold was used, was it pre‐specified? |
Yes |
|
|
| Could the conduct or interpretation of the index test have introduced bias? |
|
Low risk |
|
| Are there concerns that the index test, its conduct, or interpretation differ from the review question? |
|
|
Low concern |
| DOMAIN 3: Reference Standard |
| Is the reference standards likely to correctly classify the target condition? |
Yes |
|
|
| Were the reference standard results interpreted without knowledge of the results of the index tests? |
Unclear |
|
|
| Could the reference standard, its conduct, or its interpretation have introduced bias? |
|
Low risk |
|
| Are there concerns that the target condition as defined by the reference standard does not match the question? |
|
|
Low concern |
| DOMAIN 4: Flow and Timing |
| Was there an appropriate interval between index test and reference standard? |
Yes |
|
|
| Did all patients receive the same reference standard? |
Yes |
|
|
| Were all patients included in the analysis? |
No |
|
|
| Could the patient flow have introduced bias? |
|
Unclear risk |
|
