We have located links that may give you full text access.
PROs in the wild: Assessing the validity of patient reported outcomes in an electronic registry.
Computer Methods and Programs in Biomedicine 2019 January 18
BACKGROUND AND OBJECTIVES: Collecting Patient-Reported Outcomes (PROs) is an important way to get first-hand information by patients on the outcome of treatments and surgical procedure they have undergone, and hence about the quality of the care provided. However, the quality of PRO data cannot be given for granted and cannot be traced back to the dimensions of timeliness and completeness only. While the reliability of these data can be guaranteed by adopting standard and validated questionnaires that are used across different health care facilities all over the world, these facilities must take responsibility to assess, monitor and ensure the validity of PROs that are collected from their patients. Validity is affected by biases that are hidden in the data collected. This contribution is then aimed at measuring bias in PRO data, for the impact that these data can have on clinical research and post-marketing surveillance.
METHODS: We considered the main biases that can affect PRO validity: Response bias, in terms of Acquiescence bias and Fatigue bias; and Non-Response bias. To assess Acquiescence bias, phone interviews and online surveys were compared, adjusted by age. To assess Fatigue bias, we proposed a specific item about session length and compared PROs scores stratifying according to the responses to this item. We also calculated the intra-patient agreement by conceiving an intra-interview test-retest. To assess Non-Response bias, we considered patients who participated after the saturation of the response-rate curve as proxy of potential non respondents and compared the outcomes in these two strata. All methods encompassed common statistical techniques and are cost-effective at any facility collecting PRO data.
RESULTS: Acquiescence bias resulted in significantly different scores between patients reached by either phone or email. In regard to Fatigue bias, stratification by perceived fatigue resulted in contrasting results. A relevant difference was found in intra-patient agreement and an increasing difference in average scores as a function of interview length (or completion time). In regard to Non-Response bias, we found non-significant differences both in scores and variance.
CONCLUSIONS: In this paper, we present a set of cost-effective techniques to assess the validity of retrospective PROs data and share some lessons learnt from their application at a large teaching hospital specialized in musculoskeletal disorders that collects PRO data in the follow-up phase of surgery performed therein. The main finding suggests that response bias can affect the PRO validity. Further research on the effectiveness of simple and cost-effective solutions is necessary to mitigate these biases and improve the validity of PRO data.
METHODS: We considered the main biases that can affect PRO validity: Response bias, in terms of Acquiescence bias and Fatigue bias; and Non-Response bias. To assess Acquiescence bias, phone interviews and online surveys were compared, adjusted by age. To assess Fatigue bias, we proposed a specific item about session length and compared PROs scores stratifying according to the responses to this item. We also calculated the intra-patient agreement by conceiving an intra-interview test-retest. To assess Non-Response bias, we considered patients who participated after the saturation of the response-rate curve as proxy of potential non respondents and compared the outcomes in these two strata. All methods encompassed common statistical techniques and are cost-effective at any facility collecting PRO data.
RESULTS: Acquiescence bias resulted in significantly different scores between patients reached by either phone or email. In regard to Fatigue bias, stratification by perceived fatigue resulted in contrasting results. A relevant difference was found in intra-patient agreement and an increasing difference in average scores as a function of interview length (or completion time). In regard to Non-Response bias, we found non-significant differences both in scores and variance.
CONCLUSIONS: In this paper, we present a set of cost-effective techniques to assess the validity of retrospective PROs data and share some lessons learnt from their application at a large teaching hospital specialized in musculoskeletal disorders that collects PRO data in the follow-up phase of surgery performed therein. The main finding suggests that response bias can affect the PRO validity. Further research on the effectiveness of simple and cost-effective solutions is necessary to mitigate these biases and improve the validity of PRO data.
Full text links
Related Resources
Trending Papers
Heart failure with preserved ejection fraction: diagnosis, risk assessment, and treatment.Clinical Research in Cardiology : Official Journal of the German Cardiac Society 2024 April 12
Proximal versus distal diuretics in congestive heart failure.Nephrology, Dialysis, Transplantation 2024 Februrary 30
Efficacy and safety of pharmacotherapy in chronic insomnia: A review of clinical guidelines and case reports.Mental Health Clinician 2023 October
World Health Organization and International Consensus Classification of eosinophilic disorders: 2024 update on diagnosis, risk stratification, and management.American Journal of Hematology 2024 March 30
Get seemless 1-tap access through your institution/university
For the best experience, use the Read mobile app
All material on this website is protected by copyright, Copyright © 1994-2024 by WebMD LLC.
This website also contains material copyrighted by 3rd parties.
By using this service, you agree to our terms of use and privacy policy.
Your Privacy Choices
You can now claim free CME credits for this literature searchClaim now
Get seemless 1-tap access through your institution/university
For the best experience, use the Read mobile app