Stefan Cano invited by FDA
On September 13th, together with Professor Anne Klassen (McMaster University) and Dr Andrea Pusic (Memorial Sloan Kettering Cancer Center), Stefan will be visiting the Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration. This will be the third time Stefan, Anne and Andrea have been invited by FDA to present on Q-PORTFOLIO measures. This time they have been asked to talk about interpretation of the BREAST-Q (http://qportfolio.org/breastq/), FACE-Q (http://qportfolio.org/faceq/), BODY-Q scores (responder definitions; cut-scores), use in clinical practice and clinical trials, and best practice guidelines for developing and evaluating PRO instruments.
SPIRIT-PRO Consensus meeting Birmingham, UK, 11-12 May 2017
Antoine Regnault, Modus Outcomes’ Global Lead – Statistics, was a panel member of the SPIRIT-PRO consensus meeting that was held in Birmingham, UK on May 11-12, 2017.
SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) is an international initiative that aims to improve the quality of clinical trial protocols by defining an evidence-based set of items to address in a protocol.
The SPIRIT-PRO extension will provide guidance on the Patient-Reported Outcome content of clinical trial protocols. It is informed by different data sources (systematic review of published guidance, evaluations of over 200 clinical trial protocols, 2-round Delphi process and a stakeholder survey).
The consensus meeting involved about 30 experts from academia, regulatory agencies, industry, institutional agencies, and scientific journals and will lead to the publication of a checklist of specific PRO protocol items to be included in trial protocols and ethical reviews.
Modus Outcomes is proud to be part of this initiative and contribute to raising the quality standards for the demonstration of treatment benefits in terms of PRO in clinical trials.
More information on SPIRIT-PRO: http://www.birmingham.ac.uk/research/activity/mds/centres/cpror/research/spirit-pro.aspx
And on twitter: @CPROR_UoB #SPIRITPRO
FDA-Duke Margolis COA workshops April 4 and 5, 2017, Washington, DC
Modus Outcomes’ CEO, Patrick Marquis, MD MBA, participated in two invitation-only workshops that convened regulatory, academic and industry experts to discuss the interpretation of meaningful within-patient change and personalized COAs – both increasing important elements in the quest to gather robust and meaningful patient and caregiver input to inform medical product development and regulatory decision-making. The two workshops explored both traditional and new technical approaches to meaningful within-patient change and personalized COAs.
Patrick presented Modus Outcomes’ approach to these questions. Our approach moves toward providing a holistic answer that addresses fundamental conceptual and measurement issues, addressing current uncertainty about the best ways to interpret or personalize COAs. This new way of interpreting change moves from existing “black box” approaches to a more transparent model, making clear the connections between the concept measures, the ruler, and the experience of patients. To learn more please contact Andrea Murison (firstname.lastname@example.org).
A link to the workshops can be found here: https://healthpolicy.duke.edu/events/developing-personalized-clinical-outcome-assessments
Modus Outcomes: 2016, a year in review
2016 brought many changes and exciting projects to Modus Outcomes.
In 2016, Modus Outcomes doubled in size! By increasing our team to 16 members, we have expanded our services and reinforced our skill-set in qualitative and quantitative science. We opened three locations for our Global Team: Letchworth Garden City, UK; Lyon – France; and our newest office in Cambridge, MA, USA.
Last year, our clients kept us very busy, and we:
- conducted more than 30 concept-driven measurement projects
- worked in more than 10 therapeutic areas (e.g. Oncology, Immunology, CNS, Rare Diseases, Pediatrics).
- interviewed more than 390 patients
- collaborated with 17 KOLs
- conducted more than 75 Rasch models on 17 instruments
- contributed to the design (including selection of outcomes, and definition of endpoints), specification of the analysis and interpretation of over 10 clinical trials, with 4 involving regulatory interaction (FDA, EMA)
In 2016, we also continued to work hard to promote the science of COA evaluation and development by:
- carrying out 9 oral presentations,
- attending 10 conferences,
- and publishing 25 papers in peer reviewed journals.
Follow us on LinkedIn to find out all the exciting news for 2017!
Best wishes for 2017!
The Modus Outcomes’ Team
Modus Outcomes’ team keeps on growing… Welcome Juliette!
Juliette Meunier, MSc, joins our team as Associate Director Statistics, FR Team Lead.
Juliette conducts research projects focused on quantitative methods, and oversees statistical project implementation.
She is also responsible for implementing and updating Modus Outcomes’ quality system related to statistical activities.
Modus Outcomes’ team grows… Welcome Jessica!
Jessica T. Markowitz, PhD, joins the Modus Outcomes team, as Associate Director, US Team Lead.
Jessica conducts research projects, focused on qualitative methods, and also leads the US team organization and project implementation.
IMEKO TC1-TC7-TC13 Joint Symposium, UC Berkeley Clark Kerr Campus, August 3-5, 2016
Modus Outcomes was pleased to attend and co-sponsor the IMEKO conference August 3-5th in Berkeley.
Stefan Cano presented on psychometrics & measurement in partnership with Ted Vosk, Jack Stenner, and Leslie Pendrill.
Why the quality of person-centered metrics counts in healthcare: past, principles and progress. Cano SJ, Pendrill L. GPCC Seminar, University of Göteborg, Sweden (May 2016)
Metrological standards for use in healthcare decision making: An update on research involving the BREAST-Q. Cano SJ, Pendrill L. International Outcome Measurement Workshop, Washington, USA (April, 2016)
Stefan is on the organizing committee of IMEKO TC1-TC7-TC13, Joint Symposium 2016, University of California, Berkeley, 3-5 August 2016
Welcome our Global Business Development Director: Andrea Murison!
Andrea’s role is to reach out to clients and bring together their business needs and Modus Outcomes’ solutions.
Read more about Andrea!
Discover our new exciting location, midway between London and Cambridge.
Stefan gave an oral presentation at the European Commission Joint Research Center at Ispra, Italy, October 2015
Why the quality of quality metrics counts in healthcare: an illustration from breast cancer surgery. Cano SJ, Pendrill LR. Putting Science into Standards: Evidence-based quality assurance – an example of breast cancer. European Commission Joint Research Centre, Ispra, Italy (October 2015)
Patrick and Stefan are co-authors of a publication on COAs
Clinical Outcome Assessments: Conceptual Foundation-Report of the ISPOR Clinical Outcomes Assessment – Emerging Good Practices for Outcomes Research Task Force. Walton MK, Powers JH 3rd, Hobart J, Patrick D, Marquis P, Vamvakas S, Isaac M, Molsen E, Cano S, Burke LB. Value Health. 2015 Sep;18(6):741-
The Making of Measurement, CRASSH University of Cambridge, UK , July 23-24, 2015
Stefan gave a talk on: “Social Measurement: Three Problems, Five Challenges, One Solution” . Cano SJ.
ISPOR 20th Annual International Meeting, Philadelphia, May 16-20, 2015
Patrick spoke at ISPOR in a session about emerging good pratices in COAs.
CLINICAL OUTCOME ASSESSMENTS (COAS): A CONCEPTUAL FOUNDATION AND DEVELOPING AND EVALUATING CLINICIAN-REPORTED OUTCOME (CLINRO) INSTRUMENTS TO ASSESS TREATMENT BENEFIT: EMERGING GOOD PRACTICES
John H. Powers, MD, FACP, FIDSA, Associate Clinical Professor of Medicine, George Washington University School of Medicine, Washington, DC, USA
- Laurie B. Burke, RPh, MPH, Founder, Lora Group, LLC, Royal Oak, MD, USA and Former Director, Study Endpoints and Labeling Development, ONDIO, CDER, U.S. Food & Drug Administration, Silver Spring, MD, USA
- Donald Patrick, PhD, MSPH, Professor, Department of Health Services & Director, Seattle Quality of Life Group & Biobehavioral Cancer Training Program, University of Washington, Seattle, WA, USA
- Stefan Cano, PhD, CPsychol, AFBPsS, Co-Founder and Chief Science Officer, Modus Outcomes LLC, Stotfold, UK
- Patrick Marquis, MD, MBA, CEO, Modus Outcomes LLC, Newton, MA, USA
There is an urgent need for a standardized conceptual foundation for clinical outcome assessments (COAs) – ClinRO, ObsRO, PRO, or PerfO measures. The differences in each type of instrument dictate different approaches for development and evaluation. The Task Force undertook guidelines for ClinRO instruments. Task Force members will open discussion by defining what should be considered a ClinRO measure and providing a framework to describe these types of measures. They will present US (FDA) and European Medicines Agency (EMA) regulatory perspectives as well as their final recommendations on evaluation of ClinRO instruments for use to document treatment benefit. Identification of the treatment benefit and endpoint based on a ClinRO score, the concept of interest that is measured and context of use, evaluation of the instrument’s measurement properties will be included. Guidelines for interpretation and implementation in clinical trials conclude the discussion. The findings of these two Task Force reports will be very beneficial to those involved in evaluating treatment benefit using any type of COA. Presented by the ISPOR Clinical Outcomes Assessment – Emerging Good Practices Task Force
Poster Presented at ISPOR 20th Annual International Meeting, Philadelphia, USA
Cano, Cleanthous, Marquis, Hobart, Naoshy, Mikol. Measuring Upper Limb Function In Multiple Sclerosis: Enhancing The Abilhand’s Performance
IOMC :International Outcome Measurement Conference, Chicago, April 21-22, 2015:
Stefan gave two presentations:
– “Individual vs Group Level Measurement: Implications for Health Care Outcomes Economics”.
Symposium 1 – Plenary Session, Tuesday April 21, 8.15 am – 9.45 am
– with Thomas Salzberger:” Investigating a Lack of Discrimination between Two Adjacent Response Categories in the Rasch Model for Ordered Categories in Health Measurement”
Paper Session 9A, Wednesday April 22, 1.30 pm – 3.00 pm
Stefan also moderated Paper Session 4A on Tuesday April 21, 1.30 pm to 3.30 pm.
Two new publications IN FULL for Stefan:
FACE-Q Scales for Health-Related Quality of Life, Early Life Impact and Satisfaction with Outcomes and Decision to Have Treatment: Development and Validation. Klassen AF, Cano SJ, Schwitzer J, Scott A, Pusic AL. Plast Reconstr Surg. 2015 135(2):375-86.
Patient-reported treatment satisfaction with oral rivaroxaban versus standard therapy in the treatment of pulmonary embolism; results from the EINSTEIN PE trial. Prins MH, Bamber L, Cano SJ, Wang MY, Erkens P, Bauersachs R, Lensing AW. Thromb Res. 2015 Feb;135(2):281-8.
PROS: Patient -Reported Outcomes in Surgery Conference, Washington, DC, January 29-30, 2015
Stefan presented at the PROS conference last week: “New Psychometric Methods: Implications for Surgery”.
Stefan keeps on publishing and e-publishing!!:
Published in full, in 2015:
Using Classical Test Theory, Item Response Theory, and Rasch Measurement Theory to Evaluate Patient-Reported Outcome (PRO) Measures: A Comparison of Worked Examples. Value in Health. Petrillo J, Cano SJ, McLeod L, Coon C. Value Health. 2015 Jan;18(1):25-34.
Lending a hand: Can DASH items help ABILHAND improve manual ability measurement in multiple sclerosis? Barrett L, Cano SJ, Zajicek JP, Hobart JC. Mult Scler. 2015 Jan 12. [Epub ahead of print]
ISPOR, 17th Annual European Congress, Amsterdam, 8-12 November 2014
Stefan had two posters and presented at a Short Course Afternoon Session on Sunday.
Four-hours Short Course:
“Applying Mixed Methods to Establish Content Validity of PRO, ClinRO, and ObsRO Assessments.”
Burke LB, Patrick DL, Hobart JC, Cano SJ. International Society for Pharmacoeconomics and Outcomes Research, Amsterdam, Netherlands.
THE PAIN ASSESSMENT FOR LOWER BACK SYMPTOMS (PAL-S): REFINEMENT OF A NEW PRO INSTRUMENT THROUGH A MIXED METHODS APPROACH. McCarrier KP, Bushnell DM, Ramasamy A, Liedgens H, Blum SI, Cano S, Martin ML, Patrick DL. International Society for Pharmacoeconomics and Outcomes Research, Amsterdam, Netherlands (November, 2014).
IMPACTS OF LOWER BACK PAIN: REFINEMENT OF THE PAIN ASSESSMENT FOR LOWER BACK-IMPACTS QUESTIONNAIRE (PAL-I) USING A MIXED METHODS APPROACH. Bushnell DM, McCarrier KP, Ramasamy A, Liedgens H, Blum SI, Cano S, Martin ML, Patrick DL. . International Society for Pharmacoeconomics and Outcomes Research, Amsterdam, Netherlands (November, 2014).
Autumn Meeting of the British Society of Rhinoplasty Surgeons, Leicester, UK
Stefan was invited to participate as a speaker in the plenary about Outcome measurement in Rhinoplasty: The Prominence & Potential of Patient Reported Outcomes.
ISOQOL (20th Annual Conference of the International Society for Quality of Life Research, Berlin, Germany):
Stefan participated in a plenary session and an oral presentation.
- Plenary session :
Expert Panel Discussion on Patient-Centered Outcome Measurement: Routes, Roadblocks, and Roadmaps (Thursday 16th October)
The Expert Panel Discussion focused on the current state of play of patient-centered outcome measurement from the perspective of the three speakers.
We first described the significant progress that has been made during our working careers, and then flagged some concerning problems in the field, in particular, the ‘routes’ (i.e. competing methodologies) and ‘roadblocks’ (i.e., barriers preventing widespread take up of state of the art techniques).
As exemplars we introduced five key challenges:
1) which measurement paradigm to guide instrument development and evaluation?
2) how to recognize the limitations of psychometric “statistics”?
3) how best to measure change over time?
4) what sample sizes for scale development and evaluation studies?
5) how to overcome the legacy of ‘legacy’ instruments?
We then described how the current best practice recommendations from the US Food and Drug Administration (the ‘Roadmap’) enable the development of clinically meaningful patient focused outcome measures.
Laurie Burke, MPH, LORA Group, LLC, United States
Jeremy C. Hobart, PhD FRCP, Clinical Neurology Research, Plymouth Univ. Peninsula Schools of Medicine and Dentistry, United Kingdom
Stefan J Cano, PhD, Modus Outcomes, Newton, MA, United States
- Oral Presentation
How Qualitative Methods Can Be Used to Ensure Content Validity in a PRO Instrument for Patients with Cleft Lip and/or Palate who Vary by Age and Culture?: Development of the CLEFT-Q.
Tsangaris E, Wong KWY, Forrest CR, Pusic A, Cano SJ, Goodacre T, Klassen AF20th Annual Conference of the International Society for Quality of Life Research, Berlin, Germ
Brookings/FDA Workshop, Washintgton DC, October 6, 2014
Patrick was invited to the Brookings/FDA workshop “Advancing Development and Use of Patient-Reported Outcomes in Drug Development: Near-Term Opportunities”. This meeting was a follow-up from a previous workshop that took place on July 16, which focused on experiences with the FDA’s guidance on PROs, as well as on challenges in capturing the patient voice across the drug development continuum.
This time, sessions focused on:
– I. Developing a Potentially Acceptable Endpoint List: Potential Value and Uses – Implementation Approaches
– II. Identifying Emerging Themes from the Acceptable Endpoints Discussion
– III. Evidentiary Considerations for Making Existing PRO Instruments Fit for Purpose
– IV. Identifying and Prioritizing Next Steps
Intense publication work by Stefan:
A new article in press:
Using Classical Test Theory, Item Response Theory, and Rasch Measurement Theory to Evaluate Patient-Reported Outcome (PRO) Measures: A Comparison of Worked Examples. Value in Health. Petrillo J, Cano SJ, McLeod L, Coon C (in press).
Just published IN FULL:
– Assessing outcomes in body contouring. Klassen AF, Cano SJ, Scott A, Tsangaris E, Pusic AL. Clinics in Plastic Surgery 2014; 41(4): 645-654.
– Staying at work and living with MS: a qualitative study of the impact of a vocational rehabilitation intervention. Jellie B, Sweetland J, Riazi A, Cano SJ, Playford ED. Disabil Rehabil. 2014 Disabil Rehabil. 2014;36(19):1594-9.
Two more publications about FACE-Q due to be presented at the American Society of Plastic Surgeons Annual Meeting: Read more about them!
Brookings/FDA Workshop, Washintgton DC, July16, 2014
Patrick was invited to the Brookings/FDA workshop “Enhancing the Development and Use of Patient-Reported Outcomes in Drug Development”, where the experience with FDA Guidance on PROs was discussed.
Sessions focused on:
– 1. Evidentiary Standards
– 2. Standardizing Communication Processes
– 3. Challenges to Capturing the Patient Voice Across the Drug Development
– 4. Next Steps in Promoting the Development and qualification of PROs
Three new publications in press for Stefan:
Lending a hand: Can DASH items help ABILHAND improve manual ability measurement in multiple sclerosis?
Barrett L, Cano SJ, Zajicek J, Hobart JC. Multiple Sclerosis Journal (in press)
Development and Validation of a Generic Scale for use in Transition Programs to Measure Self-Management Skills in Adolescents with Chronic Health Conditions: The TRANSITION-Q. Child: Care, Health & Development.
Klassen AF,Grant C, Barr R, Brill H, Olaf, K, Ronen G, Samaan C, Cano SJ, Torek, A, Athale U, Wickert N, Gorter JW (in press)
Introducing the BODY-Q: A Patient-Reported Outcome Instrument for use in Obesity, Bariatric and Body Contouring Surgery.
Klassen AF, Cano SJ, Scott A, Tsangaris E, Pusic AL. Clinics in Plastic Surgery (in press)
Summer publications by Stefan:
The development of scales to measure childhood cancer survivors’ readiness for transition to long-term follow-up care as adults.
Klassen AF, Rosenberg-Yunger ZR, D’Agostino NM, Cano SJ, Barr R, Syed I, Granek L, Greenberg ML, Dix D, Nathan PC. Journal: Health Expectations.
E-Published: July 2014
Viewpoint: Interpreting clinical differences in BREAST-Q© scores – Minimal Important Difference.
Cano SJ, Klassen AF, Scott A, Alderman A, Pusic A. Plastic and Reconstructive Surgery 134(1) 173-175
Stefan was also interviewed by the Times newspaper in the UK: “Tweets, Selfies and Surgery Trends by Antonia Mariconda” (15th July 2014)
Other recent publications:
Implant Breast Reconstruction and Radiation: a Multicenter Analysis of Long-Term Health-Related Quality of Life and Satisfaction.
Albornoz CR1, Matros E, McCarthy CM, Klassen AF, Cano SJ, Alderman AK, VanLaeken N, Lennox P, Macadam SA, Disa JJ, Mehrara BJ, Cordeiro PG, Pusic AL.
Ann Surg Oncol. 2014 Jul;21(7):2159-64. doi: 10.1245/s10434-014-3483-2. Epub 2014 Apr 18.
Towards Evidence-Based Practice in Cosmetic Surgery Using the Q-Portfolio of Patient-Reported Outcome Measures
Schwitzer J, Klassen AF, Cano SJ, Pusic AL. Aesthetic Journal; 1(7) 2014. For more information: email@example.com
Keep checking on Stefan’s academic outputs: http://www.researchgate.net/profile/Stefan_Cano?ev=hdr_xprf
FACE London, June 20 to 22, 2014
Stefan gave two lectures at FACE on introducing the FACE-Q: How Patient-Reported Outcome Measures (PROMs) can benefit clinical care.
Stefan is a Chartered Psychologist and co-developer (with Drs Anne Klassen (McMaster University, Canada) and Andrea Pusic (Memorial Sloan Kettering Cancer Center, USA)) of the BREAST-Q, FACE-Q, BODY-Q and CLEFT-Q. These PROMs quantify what patients think of the outcome (e.g., appearance, quality of life, adverse effects) following cosmetic and reconstructive treatment/surgery.
Introducing the FACE-Q:
In the aesthetics industry, patients are becoming savvy consumers. They want to know what other patients have experienced in order to make informed choices about treatments and to decide which clinician to use for optimal results. Such information gathered using the FACE-Q can be used to benefit clinical care. The FACE-Q was developed following current best practice guidelines for instrument development to satisfy the stringent requirements of governing and regulatory bodies. The FACE-Q is used internationally in clinical trials and research. It is also designed to be used by individual clinicians and technicians in their cosmetic practice to enable them to collect data from patients about expectations, satisfaction, outcomes and experience of care. For example, using the FACE-Q, a clinician may find that his or her patients considered their treatment outcomes to be excellent, but that they did not like his/her manner or were not satisfied with the office staff. Rather than lose dissatisfied patients to other providers, the clinician using the FACE-Q will better understand their patients’ concerns. Such accurate information helps to deliver higher quality care. http://www.faceconference.com/Speakers/254/Dr+Stefan+Cano
ISPOR Montreal, June 1 to 4, 2014
Both Stefan and Patrick participated as faculty or speaker in ISPOR sessions focused on good COAs measurement practices and methods.
– Sunday June1: Short Course Program in Patient-Reported Outcomes Methods
Applied Mixed Methods to establish content validity of Patient -Reported ( PRO), Clinician- Reported (ClinRo) and Observer-Reported Outcome (ObsRo) Assessments.
Faculty: Donald Patrick, MSPH, PhD; Laurie Burke, RPh, MPH; Jeremy Hobart, PhD, FRCP; Stefan J. Cano, PhD
– Monday June 2: Ispor Forums – Session 1: Ispor Clinician Reported Outcomes Good Measurement Practices
Moderator: John H. Powers, III, MD, FACP, FIDSA
Speakers: Laurie B. Burke; Patrick Marquis, MD, MBA; Ashley Slagle, PhD, MS
Copyright © 2017 Modus Outcomes®, All Rights Reserved