Although the use of rating scales in clinical research has a long history , the use of Patient Reported Outcome (PRO) instruments is a more recent trend . In the 1970s, the Health Insurance Experiment  helped a shift in focus from more traditional clinical outcomes (i.e., mortality and morbidity) to the measurement of function (i.e., the ability of patients to perform activities of daily living) . In the 1980s, phrases such as “quality of life” started to become buzz words  and many ubiquitous generic PRO instruments were born (e.g., Sickness Impact Profile,  Nottingham Health Profile,  and Short Form-36 ). The 1990s saw a proliferation of more targeted PRO instruments, including dimension-specific (e.g., mood ), disease-specific (eg, cancer ), site-specific (e.g., orthopedic ), and individualized . Since the turn of the century, there has increasing interest in embedding PRO instruments in high stakes decision making including clinical research , clinical trials  and within health information systems . In fact, it has been suggested that PRO instruments can transform healthcare into a more patient-centered model  .
However, although guidelines exist for best practice use in these high-stakes settings  , some suggest existing legacy PRO instruments may not be up to the job of delivering the required high quality data. Reasons for this have included: psychometric limitations , lack of instrument content based on patient-identified priorities , difficulty of integration into clinical settings , little evidence of effective impact , and absence of measurement standards  . In fact, the use of legacy PRO instruments in high stakes decision making has been described as being unscientific and unethical .
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In recently stated strategic priorities, the US Food and Drug Administration (FDA) expressed an interest in ‘bridging studies to adapt and update legacy PRO instruments for new indications and populations’, page 12) . In follow up to that report, this month (October, 2018) the FDA is hosting a two-day public workshop to further explore methodology surrounding PROs including the potential to modify existing instruments . In line with this, Modus Outcomes has had a long-standing interest in improving legacy PRO instruments to make them fit-for-purpose for high stakes decision-making settings (Table 1). By exploiting the diagnostic capabilities   of Rasch Measurement Theory, we have recommended adaptation, extension and enhancement to a number of widely used PRO instruments, to ensure better coverage of the concepts of interest for specific contexts of use . For example, in order to improve psychometric properties, clinical meaning and range of clinical concepts covered we have proposed:
- identification of clinically comfortable concept subsets, explore rescored response and enhancement (using bolt-on items)  of the Movement Disorder Society-sponsored revision of the Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) 
- reconceptualization and enhancement (using bolt-on items)  of the ABILHAND-56 
- rescoring response options and conceptualization and enhancement (using bolt-on items)  of the 12-item Multiple Sclerosis Walking Scale (MSWS-12) 
- reconceptualization  of the Multiple Sclerosis Impact Scale (MSIS-29) 
- identification of supplemental items   for the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 
- identification of clinically comfortable concept subsets , equating self- and proxy- report   of DEMQOL 
- reconceptualization and response option rescoring   for the 25-item National Eye Institute Visual Functioning Questionnaire (NEI VFQ25) 
We at Modus Outcomes are committed to ensuring the fair assessment of the potential benefit of new therapies and will continue to conduct research to maximize the potential of existing PRO instruments. Careful leveraging of legacy tests and rating scales addressing psychometric, conceptual, and targeting issues will lead to lead to more fit-for-purpose, relevant, meaningful and sensitive measurement of important clinical concepts in future pharmaceutical clinical trials.
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