Evidence map›Paper›PMID 29914509›Full record

Observational studyHealth and quality of life outcomes2018

A prospective observational study to assess clinical decision-making, prognosis, quality of life and satisfaction with care in patients with relapsed/refractory multiple myeloma: the CLARITY study protocol.

Fabio Efficace, Mario Boccadoro, Antonio Palumbo, Maria Teresa Petrucci, Francesco Cottone, Laura Cannella, Elena Zamagni, Pasquale Niscola, Charalampia Kyriakou, Tommaso Caravita and 3 more

Registry-linked trialOpen access · goldAbstract readObservational Study
In one paragraph

Observational study in Health and quality of life outcomes, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03190525 (CLinical Decision-making, Prognosis, quAlity of Life and Satisfaction With caRe in patIents With Relapsed/refracTory Multiple mYeloma), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.8field-weighted citation impact, top 15% of its field
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.

NCT03190525 active not recruitingnot on this map

CLinical Decision-making, Prognosis, quAlity of Life and Satisfaction With caRe in patIents With Relapsed/refracTory Multiple mYeloma (CLARITY)

TypeobservationalSponsorGruppo Italiano Malattie EMatologiche dell'AdultoRan2017 to 2025Enrolled530ConditionsMultiple MyelomaArmsQuality of life questionnaires
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 17 citations in OpenAlex.

  1. Observational
  2. Article
  3. Review
  4. Review
  5. Observational
  6. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 7 institutions in 2 countries.

Fabio EfficaceHealth Outcomes Research Unit, Gruppo Italiano Malattie EMatologiche dell'Adulto (GIMEMA), GIMEMA Data Center and Health Outcomes Research Unit, Via Benevento, 6, 00161, Rome, Italy. f.efficace@gimema.it.
Mario BoccadoroMyeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.
Antonio PalumboMyeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.
Maria Teresa PetrucciDepartment of Cellular Biotechnologies and Hematology, Sapienza University of Rome, Rome, Italy.
Francesco CottoneHealth Outcomes Research Unit, Gruppo Italiano Malattie EMatologiche dell'Adulto (GIMEMA), GIMEMA Data Center and Health Outcomes Research Unit, Via Benevento, 6, 00161, Rome, Italy.
Laura CannellaHealth Outcomes Research Unit, Gruppo Italiano Malattie EMatologiche dell'Adulto (GIMEMA), GIMEMA Data Center and Health Outcomes Research Unit, Via Benevento, 6, 00161, Rome, Italy.
Elena ZamagniSeragnoli Institute of Hematology, Bologna University School of Medicine, Bologna, Italy.
Pasquale NiscolaHaematology Unit and Pathology Department, S. Eugenio Hospital Rome, Rome, Italy.
Charalampia KyriakouDepartment of Haematology, London North West and University College London Hospitals, London, UK.
Tommaso CaravitaHaematology Unit and Pathology Department, S. Eugenio Hospital Rome, Rome, Italy.
Massimo OffidaniClinica di Ematologia, AOU Ospedali Riuniti di Ancona, Ancona, Italy.
Franco MandelliHealth Outcomes Research Unit, Gruppo Italiano Malattie EMatologiche dell'Adulto (GIMEMA), GIMEMA Data Center and Health Outcomes Research Unit, Via Benevento, 6, 00161, Rome, Italy.
Michele CavoInstitute of Hematology Seragnoli, DIMES, University of Bologna, Bologna, Italy.
Fondazione Gimema Onlus · ITAzienda Ospedaliera Citta' della Salute e della Scienza di Torino · ITSt. Eugenio Hospital · ITOspedali Riuniti di Ancona · ITSapienza University of Rome · ITUniversity College London · GBUniversity of Bologna · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTreatment decision-making in patients with relapsed/refractory multiple myeloma (RRMM) is challenging for a number of reasons including, the heterogeneity of disease at relapse and the number of possible therapeutic approaches. This study broadly aims to generate new evidence-based data to facilitate clinical decision-making in RRMM patients. The primary objective is to investigate the prognostic value of patient self-reported fatigue severity for overall survival.

methodsThis multicenter prospective observational study will consecutively enroll 312 patients with multiple myeloma who have received at least 1 prior line of therapy and are considered as RRMM according to the International Myeloma Working Group (IMWG) criteria. Eligible RRMM participants will be adults (≥ 18 years old) patients and will be enrolled irrespective of comorbidities and performance status. At the time of study inclusion, data to calculate the frailty score are to be available. Patients will be followed up for 30 months and patient-reported outcome (PRO) assessment is planned at baseline and thereafter at 3, 6, 12, and 24 months. The following PRO validated questionnaires will be used: the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), the EORTC QLQ-MY20 and the EORTC QLQ-INFO25. Satisfaction with care and preference for involvement in treatment decisions will also be evaluated. Clinical, laboratory and treatment related information will be prospectively collected in conjunction with pre scheduled PRO assessments. Cox regression analyses will be used to assess the prognostic value of baseline fatigue severity (EORTC QLQ-C30) and other patient-reported health-related quality of life parameters. DISCUSSION: Clinical decision-making in RRMM is a challenge and outcome prediction is also an important aspect to enhance personalized treatment planning. Given the paucity of PRO data in this population, this prospective observational study aims to provide novel information that may facilitate patients' management in routine practice.

trial registrationThis trial is registered as identifier NCT03190525 .

Indexed as

Clinical Decision-MakingClinical ProtocolsFemaleHumansMaleMultiple MyelomaNeoplasm Recurrence, LocalPatient Reported Outcome MeasuresPersonal SatisfactionPrognosisProspective StudiesQuality of LifeFatigueMultiple myelomaPrognosisQuality of lifeSatisfaction with careSurvival

Identifiers

PMID29914509
PMCPMC6006751
OpenAlexW2809093238

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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 OpenQuestion graph.