Migraine Physical Function Impact Diary (MPFID)
A Migraine Physical Function Impact Diary (MPFID) is a PRO assessment that is a self-administered questionnaire designed to measure the subjective impact of migraine on physical functioning (everyday activities and physical impairment) in the past 24 hours.
- AKA: 13-Item MPFID,
- Context:
- It can (typically) have 13-items measuring impact on Everyday Activities (seven items) and Physical Impairment (five items).
- It can be classified as a PRO Diary or a Disease/Condition-Specific PRO.
- …
- Example(s):
- a MPFID Version 1.0 (Mannix et al., 2017 , Fig.1),
- a MPFID-EA,
- a MPFID-PI,
- PROQOLID-MPFID,
- …
- Counter-Example(s):
- a 24-h Migraine Quality of Life Questionnaire (24-h MqoLQ),
- a HEADWORK Questionnaire,
- a Migraine Disability Assessment Score (MIDAS),
- a Migraine Functional Impact Questionnaire (MFIQ),
- a Migraine-Specific Quality of Life Questionnaire (MSQ),
- a Six-Item Headache Impact Test (HIT-6),
- a WHO Disability Assessment Schedule II (WHO-DAS II).
- See: Episodic Migraine (EM), Chronic Migraine (CM), SAFER Eligibility Check, Patient Intervention Questionnaire, Patient Intervention Outcome, Electronic Clinical Outcome Assessment (eCOA) System, Electronic Patient-Reported Outcome (ePRO), Work Productivity and Activity Impairment (WPAI) Measure, International Classification of Headache Disorders (ICHD), Neurological Disorder.
References
2021a
- (D'Amico et al., 2021) ⇒ Domenico D'Amico, Stewart J. Tepper, Erika Guastafierro, Claudia Toppo, Matilde Leonardi, Licia Grazzi, Paolo Martelletti, and Alberto Raggi (2021)."Mapping Assessments Instruments for Headache Disorders against the ICF Biopsychosocial Model of Health and Disability". In: International journal of environmental research and public health, 18(1). DOI:10.3390/ijerph18010246.
- QUOTE: Published results are mostly connected to migraine, and more specifically to chronic migraine (CM), and obtained through the use of few assessment instruments, namely the Migraine Disability Assessment scale (MIDAS)[1], the six-Item Headache Impact Test (HIT-6)[2], and the Migraine-Specific Quality of Life Questionnaire (MSQ) [3]. There is a lack of information about TTH and poor information about cluster headache (CH) [4], a condition in which most of research was designed using again the HIT-6, MIDAS, and the MSQ(...)
Almost all assessment instruments retrieved in this review have been used in migraine research, with the exclusion of two CH-specific assessments.
The most used tools were MIDAS[1], HIT-6[2], and the MSQ[3], used in 80, 56, and 27 studies, respectively. In addition to this, 11 studies employed an instrument from the WHO Disability Assessment Schedule (WHODAS) family [5],[6] (either the 36 or 12 item version), and 10 studies employed an instrument from the Short-Form (SF) Health Survey family, i.e., the SF-36, SF-12, or SF-8 [7]. The ICF-linked items by domain for each of the assessment tools used in the research papers included in our analysis are reported in Table 2(...)
Other less used tools were the Migraine Functional Impact Questionnaire (MFIQ)[8], the Migraine Physical Function Impact Diary (MFIPD)[9] addressing impact on daily functioning, and the 24-h Migraine Quality of Life Questionnaire (24-h MqoLQ), addressing various dimensions of QoL [10][11]. Finally, the HEADWORK questionnaire[12] was validated on migraine patients, although deemed to be feasible to address work-related problems of other headache patients.
- QUOTE: Published results are mostly connected to migraine, and more specifically to chronic migraine (CM), and obtained through the use of few assessment instruments, namely the Migraine Disability Assessment scale (MIDAS)[1], the six-Item Headache Impact Test (HIT-6)[2], and the Migraine-Specific Quality of Life Questionnaire (MSQ) [3]. There is a lack of information about TTH and poor information about cluster headache (CH) [4], a condition in which most of research was designed using again the HIT-6, MIDAS, and the MSQ(...)
- ↑ 1.0 1.1 Stewart, W.F.; Lipton, R.B.; Kolodner, K.; Liberman, J.; Sawyer, J. "Reliability of the Migraine Disability Assessment Score in A Population-Based Sample of Headache Sufferers". Cephalalgia 1999, 19, 107–114.
- ↑ 2.0 2.1 Kosinski, M.R.; Bayliss, M.; Bjorner, J.; Ware, J.E., Jr.; Garber, W.; Batenhorst, A.; Cady, R.; Dahlöf, C.; Dowson, A.; Tepper, S. A six-item short-form survey for measuring headache impact: The HIT-6™. Qual. Life Res. 2003, 12, 963–974.
- ↑ 3.0 3.1 Martin, B.C.; Pathak, D.S.; Sharfman, M.I.; Adelman, J.U.; Taylor, F.R.; Kwong, W.J.; Jhingran, P. Validity and reliability of the migraine-specific quality of life questionnaire (MSQ Version 2.1). Headache J. Head Face Pain 2000, 40, 204–216.
- ↑ D’Amico, D.; Raggi, A.; Grazzi, L.; Lambru, G. Disability, Quality of Life, and Socioeconomic Burden of Cluster Headache: A Critical Review of Current Evidence and Future Perspectives. Headache J. Head Face Pain 2020, 60, 809–818.
- ↑ Üstün, T.B.; Chatterji, S.; Kostanjsek, N.; Rehm, J.; Kennedy, C.; Epping-Jordan, J.; Saxena, S.; Von Korff, M.; Pull, C. Developing the World Health Organization Disability Assessment Schedule 2.0. Bull. World Health Organ. 2010, 88, 815–823.
- ↑ Garin, O.; Ayuso, J.L.; Almansa, J.; Nieto, M.; Chatterji, S.; Vilagut, G.; Alonso, J.; Cieza, A.; Svestkova, O.; Burger, H.; et al. chronic diseases. Health Qual. Life Outcomes 2010, 8, 51.
- ↑ Ware, J.J. SF-36 Health Survey. Manual and Interpretation Guide; The Health Institute, New England Medical Center: Boston, MA, USA, 1993.
- ↑ Kawata, A.K.; Hareendran, A.; Shaffer, S.; Mannix, S.; Thach, A.; Desai, P.; Mikol, D.D.; Ortmeier, B.; Bayliss, M.; Buse, D.C. Evaluating the Psychometric Properties of the Migraine Functional Impact Questionnaire (MFIQ). Headache J. Head Face Pain 2019, 59, 1253–1269.
- ↑ Kawata, A.K.; Hsieh, R.; Bender, R.; Shaffer, S.; Revicki, D.A.; Bayliss, M.; Buse, D.C.; Desai, P.; Sapra, S.; Ortmeier, B.; et al. Psychometric Evaluation of a Novel Instrument Assessing the Impact of Migraine on Physical Functioning: The Migraine Physical Function Impact Diary. Headache J. Head Face Pain 2017, 57, 1385–1398.
- ↑ Hartmaier, S.L.; Santanello, N.C.; Epstein, R.S.; Silberstein, S.D. Development of a Brief 24-Hour Migraine-Specific Quality of Life Questionnaire. Headache J. Head Face Pain 1995, 35, 320–329.
- ↑ Santanello, N.C.; Hartmaier, S.L.; Epstein, R.S.; Silberstein, S.D. Validation of a New Quality of Life Questionnaire for Acute Migraine Headache. Headache J. Head Face Pain 1995, 35, 330–337.
- ↑ Raggi, A.; Covelli, V.; Guastafierro, E.; Leonardi, M.; Scaratti, C.; Grazzi, L.; Bartolini, M.; Viticchi, G.; Cevoli, S.; Pierangeli, G.; et al. Validation of a self-reported instrument to assess work-related difficulties in patients with migraine: The HEADWORK questionnaire. J. Headache Pain 2018, 19, 85.
2021b
- (Lanteri-Minet et al., 2021) ⇒ Michel Lanteri-Minet, Peter J. Goadsby, Uwe Reuter, Shihua Wen, Peggy Hours-Zesiger, Michel D. Ferrari, and Jan Klatt (2021). "Effect of erenumab on functional outcomes in patients with episodic migraine in whom 2–4 preventives were not useful: results from the LIBERTY study". In: Journal of Neurology, Neurosurgery & Psychiatry, 92(5), 466-472.
- QUOTE: Additional endpoints including change from baseline in scores on the everyday activities (EA) and physical impairment (PI) subdomains of the Migraine Physical Function Impact Diary (MPFID), as well as the percentage of patients showing a ≥5-point reduction in the MPFID-EA and MPFID-PI are evaluated in the current article. The MPFID is a self-administered, 13-item instrument measuring impact on EA (seven items) and PI (five items), with one stand-alone global question providing an assessment of overall impact on EA.
2020
- (Evidera, 2020) ⇒ https://www.evidera.com/migraine-physical-function-impact-diary-mpfid/
- QUOTE: The Migraine Physical Function Impact Diary (MPFID) is a 13-item self-report questionnaire, developed to measure the subjective impact of migraine on physical functioning (everyday activities and physical impairment) in the past 24 hours. It is intended for use in adults (age 18 or older) with episodic migraine (EM) or chronic migraine (CM), with or without aura. The diary was developed using methods consistent with the regulatory guidance on patient-reported outcome (PRO) measures to support label claims about the benefit of treatments.
The MPFID was designed to be completed every day to capture the day-to-day variability of the impact of migraine, on migraine and non-migraine days.
The MPFID was conceptually designed to capture both ‘acts’ and ‘tasks’ associated with the impact of migraine on functioning. The MPFID includes multiple domains to assess the impact of migraine on physical functioning:
- QUOTE: The Migraine Physical Function Impact Diary (MPFID) is a 13-item self-report questionnaire, developed to measure the subjective impact of migraine on physical functioning (everyday activities and physical impairment) in the past 24 hours. It is intended for use in adults (age 18 or older) with episodic migraine (EM) or chronic migraine (CM), with or without aura. The diary was developed using methods consistent with the regulatory guidance on patient-reported outcome (PRO) measures to support label claims about the benefit of treatments.
2017a
- (Kawata et al., 2017) ⇒ Ariane K. Kawata, Ray Hsieh, Randall Bender, Shannon Shaffer, Dennis A. Revicki, Martha Bayliss, Dawn C. Buse, Pooja Desai, Sandhya Sapra, Brian Ortmeier, and Asha Hareendran (2017). "Psychometric Evaluation of a Novel Instrument Assessing the Impact of Migraine on Physical Functioning: The Migraine Physical Function Impact Diary". In: Headache: The Journal of Head and Face Pain, 57(9), 1385-1398. DOI:10.1111/head.13162.
- QUOTE: The objective of this study was to evaluate the measurement properties of the Migraine Physical Function Impact Diary (MPFID), a novel patient-reported outcome (PRO) measure for assessing the impact of migraine on physical functioning.
In a prospective, observational study, adults with episodic migraine (EM) or chronic migraine (CM) used an eDiary to complete the MPFID (assessing daily impacts of migraine on physical function) and a headache diary (capturing migraine days, migraine pain intensity, and migraine interference) each day, and other PRO instruments related to migraine. Item-level evaluation, item response theory (IRT), and exploratory factor analysis (EFA) methods were applied to identify domains, select final MPFID items, and develop scoring procedures. Psychometric properties of the final 13-item MPFID were evaluated using confirmatory factor analysis and tests of reliability (Cronbach's $\alpha$ for internal consistency and intra-class correlation (ICC) for test–retest) and validity (convergent and known-groups)(...)
The MPFID has robust psychometric properties (ie, reliability and validity). Findings supported two distinct domains about the impact of migraine on physical functioning: Impact on Everyday Activities and Physical Impairment. Both domain scores showed evidence of excellent reliability and construct validity in assessing the impacts of migraine on physical functioning.
- QUOTE: The objective of this study was to evaluate the measurement properties of the Migraine Physical Function Impact Diary (MPFID), a novel patient-reported outcome (PRO) measure for assessing the impact of migraine on physical functioning.
2017b
- (Mannix et al., 2017) ⇒ Asha Hareendran, Sally Mannix, Anne Skalicky, Martha Bayliss, Andrew Blumenfeld, Dawn C. Buse, Pooja R. Desai, Brian G. Ortmeier, and Sandhya Sapra (2017). "Development and exploration of the content validity of a patient-reported outcome measure to evaluate the impact of migraine- the migraine physical function impact diary (MPFID)". In: Health and Quality of Life Outcomes, volume 15, Article number: 224.
- QUOTE: The item stems, instructions, and response options of the 17 items of MPFID version 0.1 were developed to reflect the dimensions in the conceptual framework and were based on language used by participants during qualitative interviews [1] to ensure the appropriateness, relevance, understanding, and clarity of included items (...)
The MPFID was developed and tested with adults with migraine using an iterative qualitative research process to confirm content validity (..., ...). The methods followed the guidelines from the US FDA for the development of PRO instruments to support label claims (..., ..., ...). The content of the instrument was based on insights from adults with migraine (..., ..., ...). It is the first PRO instrument designed to collect data about the impact of migraine on everyday acts and tasks experienced on days with migraine as well as the days in-between migraines.
The MPFID was developed in response to the paucity of existing instruments for evaluating patient-reported concepts on the impact of migraine on physical functioning a key concept of interest for evaluating the benefits of interventions for the prevention of migraines [1]. Though existing instruments covered the impacts on everyday tasks, none of them included items about the impact on acts, that were identified both in the CE interviews that formed the basis of the development of the MPFID[1] but also identified by Leonardi et al. (2010) [2], when a broader framework following the ICF was used to explore impacts of migraine.
The MPFID was designed for completion as a daily diary to capture the impact on migraine days as well as the days in between migraines (..., ..., ...). The MPFID can therefore be used to complement migraine diaries that usually include assessments about migraine symptoms(...)
The intent is to ensure that the final version of the MPFID is a clinically relevant and psychometrically sound measure of patients’ perceptions of functional impacts in adults with migraine for evaluating outcomes of preventive medication for migraine in clinical research and clinical practice.
- QUOTE: The item stems, instructions, and response options of the 17 items of MPFID version 0.1 were developed to reflect the dimensions in the conceptual framework and were based on language used by participants during qualitative interviews [1] to ensure the appropriateness, relevance, understanding, and clarity of included items (...)
- ↑ 1.0 1.1 1.2 Mannix S, Skalicky A, Buse DC, Desai P, Sapra S, Ortmeier B, Widnell K, Hareendran A. "Measuring the impact of migraine for evaluating outcomes of preventive treatments for migraine headaches. Health Qual Life Outcomes". 2016;14:143.
- ↑ Leonardi M, Raggi A, Ajovalasit D, Bussone G, D'Amico D. "Functioning and disability in migraine". Disabil Rehabil. 2010;32(Suppl 1):S23–32.