[PDF] Top 20 Potential of patient-reported outcomes as nonprimary endpoints in clinical trials
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Potential of patient-reported outcomes as nonprimary endpoints in clinical trials
... PRO endpoints in registration trials and instead seek them in new ...as nonprimary endpoints with the rigor required to secure a labeling ...confirmatory clinical trials ... See full document
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Failure to address potential bias in non-randomised controlled clinical trials may cause lack of evidence on patient-reported outcomes: a method study
... lack of randomisation poses a very large challenge to the authors who are advised to deal with essential problems such as selection bias and confounding. Otherwise, the fi ndings may not be valid and of limited usefulness ... See full document
9
Patient-reported outcomes in randomised controlled trials of gynaecological cancers: Investigating methodological quality and impact on clinical decision-making
... a patient reported outcome (PRO) assessment to fully capture patients’ percep tions of symptoms, functioning, and general ...controlled clinical trials (RCTs) as it can potentially generate ... See full document
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The impact of patient-reported outcome (PRO) data from clinical trials: a systematic review and critical analysis
... oncology clinical trials [88]; CONSORT-PRO Extension to facili- tate optimal reporting guidance of trials that include PROs as primary or secondary outcome [46] and; the work carried out by Snyder et ... See full document
19
Patient-reported outcomes in randomised clinical trials of bladder cancer: an updated systematic review
... In the context of bladder cancer, a systematic review encompassing the years 2004–2014 examined the quality of PRO reporting and methodological strengths and weaknesses of RCTs. It concluded that few RCTs report PRO as ... See full document
11
Interpreting patient-reported outcomes from clinical trials in COPD: a discussion
... of patient-reported outcomes (PROs) in clinical trials and the relevance of such data to their ...the patient perspective, many clinical trials now include ... See full document
10
Imaging endpoints for clinical trials in Alzheimer’s disease
... Imaging endpoints provide at least three possible bene- fits to clinical trials in ...assessing potential disease-modifying effects and differentiating these from symptomatic benefits that do ... See full document
10
Can patient-reported outcomes be used instead of clinician-reported outcomes and photographs as primary endpoints of late normal tissue effects in breast radiotherapy trials? Results from the IMPORT LOW trial.
... with patient-reported symptoms from the Quality-of-Life Questionnaire ...of clinical oncology : official journal of the American Society of Clinical ...Self- reported quality of life of ... See full document
15
<p>Patient-Reported Outcomes (PROs) in COPD Clinical Trials: Trends and Gaps</p>
... coping. Patient-reported outcomes (PROs) are essential to evaluate symptoms, impact of symptoms on activities of daily living, and treatment ...PRO endpoints from rando- mized controlled ... See full document
12
Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials: a start in setting international standards
... other patient-reported outcomes (PRO) generate important data in cancer randomized controlled trials (RCTs) to assist in evaluating the risks and benefits of cancer therapies, and fostering ... See full document
19
A systematic evaluation of compliance and reporting of patient-reported outcome endpoints in ovarian cancer randomised controlled trials: implications for generalisability and clinical practice
... HRQOL outcomes; “in- formative” missing PRO ...RCTs reported incomplete compliance in- formation, meaning that despite the authors’ attempts to report information about missing data, it was unclear whether ... See full document
10
Validity and reliability of patient reported outcomes used in Psoriasis: results from two randomized clinical trials
... assessed clinical endpoints and dermatology-specific patient-reported HRQL and limitations of functional abil- ity to obtain a more comprehensive view of the impacts of the disease and its ... See full document
9
The CONSORT Patient-Reported Outcome (PRO) extension: implications for clinical trials and practice
... in clinical trials ...the potential to foster greater consideration of a PRO measure’s psychometric properties at the time of protocol design, thereby promoting greater use of measures with demon- ... See full document
7
Challenges in translating end points from trials to observational cohort studies in oncology
... Abstract: Clinical trials are considered the gold standard for examining drug efficacy and for approval of new ...translating endpoints from oncology trials to observational ...rare ... See full document
6
Patient-reported outcomes in neurofibromatosis and schwannomatosis clinical trials
... NF clinical trials, especially for assessing changes in symp- toms such as pain (personal communication, ...important endpoints in clinical trials for NF-related ...in trials for ... See full document
11
Patient-reported outcomes of pain and physical functioning in neurofibromatosis clinical trials
... as endpoints across trials to assess clinical benefit of treatments to reduce tumors or other disease manifestations in indi- viduals with NF1, NF2, and ...NF clinical trials will be ... See full document
11
The importance of patient-reported outcomes in clinical trials and strategies for future optimization
... Abstract: Patient-reported outcomes (PROs) can be included in clinical trials as primary or secondary endpoints and are increasingly recognized by regulators, clinicians, and ... See full document
15
Individualizing endpoints in randomized clinical trials to better inform individual patient care: the TARGET proposal
... same endpoints, both primary and secondary, for all study ...to endpoints for RCTs offers the advantage of simplicity and ...several trials before being adopted as a primary endpoint for any ... See full document
8
Measuring what matters to rare disease patients – reflections on the work by the IRDiRC taskforce on patient-centered outcome measures
... main potential outcomes at the end of this process: the instrument is deemed fit for purpose in the specific context of use; the instrument is broadly acceptable but requires adaptation [Table 5]; a new ... See full document
13
Patient-reported outcomes in randomised controlled trials of gynaecological cancers: Investigating methodological quality and impact on clinical decision-making
... Medical Outcomes Study Short Form 36-Item Health Survey; SAQ: the Sexual Activity Questionnaire; BIS: Body Image Scale; MOS-SF36 PF: The Physical Functioning Subscale of the Medical Outcome Study Short Form; AP: ... See full document
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