Evidence map›Paper›PMID 41162921›Full record

ArticleBMC cancer2025

Study protocol for developing a patient-reported outcome measure for infection screening in hematological patients with secondary immunodeficiency.

Jens Lehmann, Jan-Paul Bohn, Claudia Seidl, Samuel M Vorbach, Wolfgang Willenbacher, Bernhard Holzner, Markus Schuler

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMC cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06821880 (Developing a Patient-Reported Outcome), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
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1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06821880 recruitingnot on this map

Developing a Patient-Reported Outcome (PRO) Screening Measure for Infections and Measuring Quality of Life in Hematological Patients With Secondary Immunodeficiency (SID) Across the Treatment Trajectory - The PRO SID Project

TypeobservationalSponsorMedical University InnsbruckRan2025 to 2026Enrolled120ConditionsChronic Lymphocytic Leukaemia (CLL), Multiple Myeloma (MM), Secondary Immunodeficiency (SID)
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

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4 · The record

Corrections and comments

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5 · Who and what money

Authors and funding

7 authors.

Jens LehmannUniversity Hospital of Psychiatry II, Medical University of Innsbruck, Anichstraße 35, Innsbruck, AT-6020, Austria. jens.lehmann@i-med.ac.at.
Jan-Paul BohnDepartment of Internal Medicine V, Hematology and Oncology, Medical University of Innsbruck, Innsbruck, Austria.
Claudia SeidlUniversity Hospital of Psychiatry II, Medical University of Innsbruck, Anichstraße 35, Innsbruck, AT-6020, Austria.
Samuel M VorbachDepartment of Radiation Oncology, Medical University of Innsbruck, Innsbruck, Austria.
Wolfgang WillenbacherDepartment of Internal Medicine V, Hematology and Oncology, Medical University of Innsbruck, Innsbruck, Austria.
Bernhard Holzner *University Hospital of Psychiatry II, Medical University of Innsbruck, Anichstraße 35, Innsbruck, AT-6020, Austria.
Markus Schuler *Onkologischer Schwerpunkt am Oskar-Helene-Heim, Berlin, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients with chronic lymphocytic leukemia (CLL) or multiple myeloma (MM) frequently develop secondary immunodeficiencies (SID), on the basis of both their respective disease, as well as immunosuppressive therapies, leading to increased infection risks and impaired health-related quality of life (HRQOL). While timely infection detection is essential, outpatient symptom monitoring remains challenging. Electronic patient-reported outcome (ePRO) tools have shown promise for real-time symptom monitoring, enhancing early detection and management. We describe a study protocol for developing an ePRO screening tool to monitor infections and assessing HRQOL in patients with SID and chronic lymphocytic leukemia (CLL) or multiple myeloma (MM).

methodsThe study consists of two phases. We first developed an item list to measure infection-related symptoms and a mobile application for the daily assessment of the item list. The study will be conducted with 120 patients across multiple centers in Austria and Germany, observing patient-reported symptoms and HRQOL over a 12-month period. The primary outcome is the predictive accuracy of the PRO screening tool for infection detection. Secondary outcomes include health-related quality of life, the incidence rate of infections, and completion rates of the scheduled PRO assessments during the study period. DISCUSSION: The PRO-SID study will evaluate whether remote symptom monitoring for infections can help detect infections in patients with hematological malignancies with SID, a population where early detection is critical for reducing morbidity and mortality. By potentially improving infection detection in outpatient settings, our study has the potential to make treatment safer and more effective for patients, ultimately enhancing clinical outcomes and reducing the risk of severe infection-related complications.

trial registrationhttps://clinicaltrials.gov/study/NCT06821880 .

Indexed as

Immunologic Deficiency SyndromesInfectionsLeukemia, Lymphocytic, Chronic, B-CellMultiple MyelomaPatient Reported Outcome MeasuresFemaleHumansMaleMulticenter Studies as TopicObservational Studies as TopicQuality of LifeCancerElectronic data collectionElectronic patient-reported outcome (ePRO)InfectionPatient reported outcome measuresSecondary immunodeficiency

Identifiers

PMID41162921
PMCPMC12570611

What Socratic holds

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LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.