Can daily self-assessment induce a learning effect mitigating pain evaluation error in clinical trials?

2021 ◽  
Vol 29 ◽  
pp. S262-S263
Author(s):  
A. Ooghe ◽  
S. Branders ◽  
A. Pereira
2012 ◽  
Vol 2012 ◽  
pp. 1-15 ◽  
Author(s):  
Kathleen W. Wyrwich ◽  
Ariane K. Kawata ◽  
Christine Thompson ◽  
Stefan Holmstrom ◽  
Malcolm Stoker ◽  
...  

Introduction. A five-item Self-Assessment of Treatment (SAT) was developed to assess improvement and satisfaction with treatment associated with the application of a novel high concentration 8% capsaicin topical patch in clinical trials in patients with postherpetic neuralgia (PHN). This study evaluated the item performance and psychometric properties of the SAT. Methods. The SAT, Brief Pain Inventory, SF-36v2, Short-Form McGill Pain Questionnaire, and Patient and Clinician Global Impression of Change (PGIC; CGIC) scores were measured in two 12-week Phase 3 clinical trials. Factor analysis assessed the underlying factor structure, followed by examination of the reliability and validity of the multi-item domain. Results. Pooled data from 698 patients completing SAT after 12 weeks of treatment were analyzed. A one-factor model combining three of the five items emerged as the optimal solution. Internal consistency reliability of this treatment efficacy factor was high (Cronbach's alpha = 0.89). Construct validity was demonstrated by moderate to high correlations with change in other study endpoints. SAT mean scores consistently discriminated between patient change groups defined by PGIC and CGIC. Conclusions. The measurement properties of the three-item version of SAT are valid and reliable for assessment of treatment with a high concentration capsaicin patch among patients with PHN.


Neurology ◽  
2021 ◽  
pp. 10.1212/WNL.0000000000012424
Author(s):  
Heather L. Thompson ◽  
Ann Blanton ◽  
Barbara Franklin ◽  
Vanessa L. Merker ◽  
Kevin H. Franck ◽  
...  

Objective:To systematically evaluate published patient-reported outcome measures for the assessment of hearing function and hearing-related quality of life, and subsequently recommend measures selected by the Response Evaluation in Neurofibromatosis and Schwannomatosis International Collaboration (REiNS) as endpoints for clinical trials in Neurofibromatosis Type 2.Methods:The REiNS patient-reported outcomes working group systematically evaluated published patient-reported outcome measures of (1) hearing function and (2) hearing-related quality of life for individuals with hearing loss of various etiologies using previously published REiNS rating procedures. Ten measures of hearing functioning and 11 measures of hearing-related quality of life were reviewed. Measures were numerically scored and compared primarily on their participant characteristics (including participant age range and availability of normative data), item content, psychometric properties, and feasibility for use in clinical trials.Results:The Self-Assessment of Communication and the Self-Assessment of Communication-Adolescent were identified as most useful for adult and pediatric populations with NF2, respectively, for the measurement of both hearing function and hearing-related quality of life. Measures were selected for their strengths in participant characteristics, item content, psychometric properties, and feasibility for use in clinical trials.Conclusions:Currently, REiNS recommends the Self-Assessment of Communication adult and adolescent forms for the assessment of patient-reported hearing function and hearing-related quality of life for clinical trials for neurofibromatosis type 2. Further work is needed to demonstrate the utility of these measures in evaluating pharmacological and/or behavioral interventions.


2015 ◽  
Vol 28 (1) ◽  
pp. 16 ◽  
Author(s):  
ShubhoSubrata Biswas ◽  
Vaishali Jain ◽  
Vandana Agrawal ◽  
Maninder Bindra

2021 ◽  
Vol 10 (11) ◽  
pp. 2328
Author(s):  
Marcello De Angelis ◽  
Luigi Lavorgna ◽  
Antonio Carotenuto ◽  
Martina Petruzzo ◽  
Roberta Lanzillo ◽  
...  

Clinical trials in multiple sclerosis (MS) have been including digital technology tools to overcome limitations in treatment delivery and disease monitoring. In March 2020, we conducted a systematic search on pubmed.gov and clinicaltrials.gov databases (with no restrictions) to identify all relevant published and unpublished clinical trials, in English language, including MS patients, in which digital technology was applied. We used “multiple sclerosis” and “clinical trial” as the main search words, and “app”, “digital”, “electronic”, “internet” and “mobile” as additional search words, separately. Digital technology is part of clinical trial interventions to deliver psychotherapy and motor rehabilitation, with exergames, e-training, and robot-assisted exercises. Digital technology has been used to standardise previously existing outcome measures, with automatic acquisitions, reduced inconsistencies, and improved detection of symptoms (e.g., electronic recording of motor performance). Other clinical trials have been using digital technology for monitoring symptoms that would be otherwise difficult to detect (e.g., fatigue, balance), for measuring treatment adherence and side effects, and for self-assessment purposes. Collection of outcome measures is progressively shifting from paper-based on site, to internet-based on site, and, in the future, to internet-based at home, with the detection of clinical and treatment features that would have remained otherwise invisible. Similarly, remote interventions provide new possibilities of motor and cognitive rehabilitation.


2021 ◽  
Vol 4 ◽  
pp. 35
Author(s):  
Anne Cody ◽  
Maura Hiney ◽  
Patricia Clarke ◽  
Mairead O'Driscoll

As a public funder of health research, the Health Research Board (HRB) Ireland has an obligation to manage its funds well and to maximise the value of the research that it funds. Ways in which research funding can be wasted have been examined by researchers over the years, and a seminal series on research waste was published in the Lancet in 2014. The series systematically analysed every step of the funding lifecycle in five major stages and made recommendations to various actors including research funders. Prompted by its participation in the Ensuring Value in Research Funders’ Forum, between June and October 2019 the HRB undertook a self-audit against the 17 recommendations identified in the Lancet series. Key HRB staff collated relevant policies and practices regarding each recommendation and sub-recommendation and assessed the HRB’s performance under each heading. The self-assessment reflects the state of HRB policies and practices in October 2019.  Of the 17 recommendations, five were found to be areas of strength and six were found to be areas of partial strength. Areas of strength reflect work over many years such as support for evidence synthesis, strong processes around award selection, driving research integrity and open data including an HRB-funded open publishing platform. Four recommendations were found to be areas for growth. These mostly revolve around real time reporting of study protocols and of ongoing funded research outside of clinical trials. Work is progressing to address some of these areas. Two were found not to apply to the HRB.


2020 ◽  
Vol 7 (7) ◽  
pp. 1148-1157 ◽  
Author(s):  
Seward B. Rutkove ◽  
Pushpa Narayanaswami ◽  
Visar Berisha ◽  
Julie Liss ◽  
Shira Hahn ◽  
...  

2020 ◽  
Vol 7 ◽  
Author(s):  
Diana Foster

Background: The purpose of this study was to evaluate the reliability and construct validity of the Diversity Site Assessment Tool (DSAT), a self-assessment instrument designed to self-report the extent to which best practices related to recruitment of diverse patient populations during clinical trials are used. Methods: A cross-sectional design was used. The convenience sample consisted of site representatives who are members of the Society for Clinical Research Sites and network site representatives that were approached via social media sites such as LinkedIn. A link to the survey was shared with approximately 17,000 aforementioned site representatives over a period of three months. The survey consisted of one section each for the indicators of best practice for the recruitment of diverse patient populations during clinical trials: 1) Site Overview (10 items), 2) Site Recruitment and Outreach (9 items) and 3) Patient Focused Services (6 items). These three indicators and the total of 25 items make up the DSAT. Each of the total 25 items on DSAT required participants to self-report on a 6-point scale. The fourth section collected background information about the participant and their site. After the survey was closed, two types of summative scores were compiled, one for each of the indicators and an overall summative DSAT score (range from 25-150). Higher summative scores on each indicator and the overall DSAT are reflective of increased use of best practices for the recruitment of diverse patient population during clinical trials. Internal consistency reliability (Cronbach’s alpha) and construct validity for the entire sample were evaluated and are reported. Bivariate and multivariate statistics were conducted to examine the relationship between site characteristics and their summative indicator and DSAT overall scores. Results: The instrument was deemed to have exceptional reliability. Cronbach's alpha coefficient for internal consistency reliability for the entire sample was 0.929. Construct validity established using the exploratory factor analysis indicated a three component solution accounting for 49% of the explained variance. There was no statistically relationship between site characteristics and their summative indicator and DSAT overall scores.   Conclusion: The DSAT has exceptional reliability and good construct validity. When paired with the findings that site characteristics have no statistical relationship with the DSAT indicators and overall summative scores, it is contended that this instrument could be used by different site backgrounds as a self-assessment measure to evaluate the extent of the use of best practices related to recruitment of diverse patient populations during clinical trials. The rigorous development of the instrument and exceptional statistical results make the tool easily the highest standard of measurement available related to this construct.


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