Myelofibrosis Symptom Assessment Form v4.0 (MFSAF v4.0) 7-day Recall

OVERVIEW

​The PRO Consortium’s Myelofibrosis Working Group was established to review existing myelofibrosis
symptom questionnaires and work with other stakeholders to form a panel to develop a harmonized,
consensus-based PRO measure for use in future myelofibrosis trials. The harmonization panel focused
on the seven core symptoms of myelofibrosis: fatigue, night sweats, pruritus, abdominal discomfort,
pain under the ribs on the left side, early satiety, and bone pain. This effort resulted in the consensus-
based Myelofibrosis Symptom Assessment Form version 4.0 (MFSAF v4.0) which is available in two recall periods: past 24 hours (Diary) and past 7 days.

  • Measure name: Myelofibrosis Symptom Assessment Form version 4.0 (MFSAF v4.0) 7-day Recall

  • Version: 4.0

  • Number of Items: 7

  • Target patient population: Adults (aged 18 years and older) diagnosed with myelofibrosis (e.g., primary myelofibrosis, post polycythemia vera-myelofibrosis, or post essential thrombocythemia-myelofibrosis)

  • Concept of interest: Self-reported severity of core, defining symptoms of myelofibrosis

  • Recall period: Past 7 days

  • Response scale: Respondents rate the severity of their myelofibrosis symptoms at their worst using an 11-point numeric rating scale (NRS) ranging from 0 (absent) to 10 (worst imaginable)

  • Mode of data collection: Electronic administration is recommended for the MFSAF v4.0​ 7-day Recall

MFSAF v4.0 7-day Recall ITEMS

USER MANUAL

Available with license


LANGUAGE AVAILABILITY

Available translations of the MFSAF v4.0 7-day Recall can be obtained when licensing the measure.  To assure standardized translations, users are not permitted to translate the MFSAF v4.0 7-day Recall without prior, written permission from the PRO Consortium.  Permission for additional translations or certification of additional countries for an existing translation are covered via an addendum to the license agreement.  If a country for an available language is needed for which the translation has not yet been certified, cognitive interviewing is to be conducted in each target country, with a minimum of 5 participants per language/country who match the target population for as many criteria as reasonably practical. Please contact us for more details.

PREFERRED TRANSLATION VENDOR FOR MFSAF v4.0 7-day Recall

RWS Life Sciences

LICENSING
Licensing fees are assessed on a per trial/per measure basis for commercial use.​

  • ​PRO Consortium Member Firms:

    • First Language​                                                                                           $1000 USD

    • Each Additional/Available Language                                                        $500 USD

  • Non-Member Organizations​

    • First Language​                                                                                          $4000 USD

    • Each Additional/Available Language                                                      $2000 USD

 

Non-commercial use is assessed on a case-by-case basis for appropriateness and applicability.

To license an available version of the MFSAF v4.0 7-day Recall, please complete the licensing form. All of the information provided in the form will be kept strictly confidential. For questions about the measure, please contact us.

PUBLICATIONS

Gwaltney C, Paty J, Kwitkowski VE, Mesa RA, Dueck AC, Papadopoulos EJ, Wang L, Feliciano J, Coons SJ. Development of a harmonized patient-reported outcome questionnaire to assess myelofibrosis symptoms in clinical trials. Leukemia Research 2017;59:26-31.