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This instrument is intended for future use in clinical trials to collect data to support label claims related to improvements in nighttime symptoms of COPD.
The methods used for concept elicitation and cognitive interviewing closely followed the requirements for generating evidence of content validity for PRO tools, to be used to collect data to support label claims [ 12].
The Food and Drug Administration FDAA) issued a guidance document describing the necessary evidence for a Patient Reported Outcome (PRO) instrument to support label claims [[ 5]], which includes the evaluation of content validity as a key recommendation (i.e. assessment and documentation of how the PRO measures the concepts relevant to the population).
The contents of the tools were reviewed to identify a) the best coverage of concepts emerging from the concept elicitation work and b) methods used to generate the items and assess if they meet criteria for content validity required for PRO tools used to support label claims [ 16, 17].
The agreement was strong (κ = 0.61-0.8) for 'accessibility to care-communication and physical mobility' (labels A1, A2), 'outpatient acute non-mobile health related care' (label O3.1), 'self-help and volunteer care with non professional staff for accessibility to care' (label S1.2), 'low intensity social and culture structured care' (label D8.3) and 'residential with daily support' (label R12).
The aim of the present study was to develop a new PRO measure in accordance with the current FDA PRO Guidance [ 12], that could be used in clinical trials to support label claims pertaining to the benefit of treatments for nighttime symptoms of COPD (e.g., reduction of nighttime symptoms).
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Given the choice, many of those shoppers would choose to buy American, one big reason why farmers and consumer groups support labeling.
Americans overwhelmingly support labeling foods that have been genetically modified or engineered, according to a New York Times poll conducted this year, with 93 percent of respondents saying that foods containing such ingredients should be identified.
"We support labeling and safety testing for genetically modified organisms in food.
The US Food and Drug Administration FDAA) released a guidance for the development of Patient-Reported Outcome (PRO) measures to support labeling claims for new medical treatments and products [7].
In 2009, the US Food and Drug Administration FDAA) released a guidance for the development of patient-reported outcome (PRO) measures to support labeling claims for new medical treatments and products [5].
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