Medical Writing Patient-reported outcomes Medical Devices
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Volume 27, Issue 4 - Patient-reported outcomes

Medical Devices

Abstract

The good news first: Patient-reported outcomes (PRO) are basically the same in both the medical device and the pharmaceutical sectors. There are the general quality of life tools such as the EQ-5D or the Short-Form Survey questionnaires (e.g. SF-12, SF-36), and there are tools that target specific disease areas, such as the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the Oswestry Disability Index (ODI).

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References

  1. EQ-5D [cited 2018 Aug 04]. Available from Available from: https://euroqol.org/
  2. 36-Item Short Form Survey (SF-36) [cited 2018 Aug 04]. Available from Available from: http://cvoutcomes.org/pages/3214
  3. 36-Item Short Form Survey (SF-36) [cited 2018 Aug 04]. Available from Available from: https://www.rand.org/health/surveys_ tools/mos/36-item-short-form.html.
  4. CVO Cardiovascular Outcomes Inc. The Kansas City Cardiomyopathy Questionnaire [cited 2018 Aug 04]. Available from Available from: https://cvoutcomes.org/pages/3214.
  5. Fairbank JC1, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). 2000 Nov 15;25(22):2940-52; discussion 2952.
  6. Garcia-Garcia HM, McFadden EP, Farb A, et al. Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document. Circulation. 2018 Jun 12;137(24):2635-–50. doi: 10.1161/CIRCULATIONAHA. 117.029289.
  7. Guidance for Industry. Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labelling Claims [cited 2018 Aug 04]. Available from Available from: https://www.fda.gov/downloads/drugs/ guidances/ucm193282.pdf.
  8. Wong Baker Faces [cited 2018 Aug 04]. Available from Available from: http://wongbakerfaces.org/.
  9. Wikipedia. Incremental cost-effectiveness ratio [cited 2018 Aug 04]. Available from Available from: https://en.wikipedia.org/wiki/ Incremental_cost-effectiveness_ratio.
  10. Brecker S, Mealing S, Padhiar A, et al. Cost-utility of transcatheter aortic valve implantation for inoperable patients with severe aortic stenosis treated by medical management: a UK cost-utility analysis based on patient-level data from the ADVANCE study. Open Heart. 2014 Oct 23;1(1):e000155. doi: 10.1136/ openhrt-2014-000155. eCollection 2014.
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  12. Stone GW, Adams DH, Abraham WT, et al. Clinical Trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement: Part 2: Endpoint definitions: A consensus document from the Mitral Valve Academic Research Consortium. J Am Coll Cardiol. 2015 Jul 21;66(3):308–21.

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Articles

Patient reported outcomes
President's Message
EMWA News
Measuring health outcomes: The foundation of contemporary healthcare decision-making
Measuring quality of life – theoretical background
Quality of life measures – an overview
Publication planning and patient-reported outcomes: Demonstrating value in a multi-stakeholder era
Patient-reported outcome measure translation: An overview
Systematic hospital collection of patient-reported outcome data via patient apps
The PROMIS of electronic patient-reported outcomes
Interview with Professor Matthias Rose on developing patient-reported outcomes and the PROMIS initiative
The UK pharmaceutical industry braces for Brexit, be it mild, severe, or doomsday
Awareness of medical writing as a profession and its career prospects
Estimands – closing the gap between study design and analysis
Protecting the rights of clinical trial patients through disclosure: The significance of plain language
News from the EMA
Regulatory Matters & Regulatory Public Disclosure
Medical Communications
Medical Devices
Journal Watch
In the Bookstores
Good Writing Practice
Getting Your Foot In The Door
My First Medical Writing
Out on Our Own

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