Mabel Crescioni - Academia.edu (original) (raw)

Papers by Mabel Crescioni

Value in Health, May 1, 2020

Journal of Patient-Reported Outcomes

Background There is interest in participants using their own smartphones or tablets (“bring your ... more Background There is interest in participants using their own smartphones or tablets (“bring your own device”; BYOD) to complete patient-reported outcome (PRO) measures in clinical studies. Our study aimed to qualitatively evaluate participants’ experience using a provisioned device (PD) versus their own smartphone (BYOD) for this purpose. Methods Participants with chronic obstructive pulmonary disease (COPD) were recruited for this observational, cross-over study and completed PRO measures daily on one device type for 15 days, then switched to the other device type to complete the same measures for another 15 days. After each 15-day period, semi-structured interviews were conducted about their experience with the device. Results Of 64 participants enrolled, the final qualitative analysis populations comprised those who participated in an interview without protocol violations. Thus, the qualitative longitudinal population (LP) included n = 57 (89%), while the qualitative cross-sectio...

Therapeutic Innovation & Regulatory Science, 2022

Implementing clinical outcome assessments electronically in clinical studies requires the sponsor... more Implementing clinical outcome assessments electronically in clinical studies requires the sponsor and electronic clinical outcome assessment (eCOA) provider to work closely together to implement study-specific requirements and ensure consensus-defined best practices are followed. One of the most important steps is for sponsors to conduct user acceptance testing (UAT) using an eCOA system developed by the eCOA provider. UAT provides the clinical study team including sponsor or designee an opportunity to evaluate actual software performance and ensure that the sponsor’s intended requirements were communicated clearly and accurately translated into the system design, and that the system conforms to a sponsor-approved requirements document based on the study protocol. The components of an eCOA system, such as the study-specific application, customization features, study portal, and custom data transfers should be tested during UAT. While the provider will perform their own system valida...

Value in Health, 2017

A679 detail for evidence of SARs. A SAR was any unfavourable/unintended observation including sid... more A679 detail for evidence of SARs. A SAR was any unfavourable/unintended observation including side effects recorded in the EPR whether or not considered to be product-related and that occurred within 31 days of first glucocorticoid treatment. Results: Overall, 28,472 dogs received at least one systemic glucocorticoid during 2013 (6.2% of study dogs, 95%CI 6.2-6.3) with 30,570 oral (60.0% of total) and 20,606 injectable (40% of total) glucocorticoid events. Prednisolone represented the most frequently used oral preparation (27,362 events (90.0%)) and dexamethasone preparations were the most common injectable therapeutic (19,671 events (96.4%)). After detailed review of the EPR from the random selection of 2,110 dogs receiving systemic glucocorticoids, 106 dogs (5.0%, 95% CI 4.1-6.0%) had a total of 169 SARs recorded. The most frequent of these were polydipsia (38 events, 22.5%), polyuria (27, 16.0%), vomiting (19, 11.2%), diarrhoea (16, 9.5%) and polyphagia (15, 8.9%). In 34 (20.1%) of these events the dose of the glucocorticoid was subsequently reduced whilst in 15 (8.9%) the therapy was discontinued. ConClusions: Systemic glucocorticoid therapy was a frequent treatment in dogs attending primary-care practice, with a clinically relevant minority experiencing at least one SAR. This is a conservative quantification as only the SARS that were reported or identified by the veterinarian were included in the study.

Value in Health, 2017

Objectives: Medication adherence has been shown to be associated with the nature of the disease b... more Objectives: Medication adherence has been shown to be associated with the nature of the disease being treated and characteristics of the prescribed treatment. Non-adherence typically ranges between 30-50% of all patients. In addition, patients' beliefs about health and illness and their behavioral expressions of their personality types may be important contributors to medication adherence. The objective of this study was to describe the associations between disease type, financial hardship and four personality temperaments (Traditionalists, Experiencers, Idealists, Conceptualizers) with self-reported medication adherence. MethOds: Data were collected from the 2015 National Consumer Survey of the Medication Experience and Pharmacists' Roles, via an on-line, self-administered survey coordinated by Qualtrics Panels in the United State of America, between April 28, 2015, and June 22, 2015. Data were analyzed using IMB/SPSS version 24.0 software. Logistic regression analysis and descriptive statistics were used. Results: Out of 26,173 responses, 12,195 were taking at least one prescription medication and were not a licensed health professional, making them eligible for this study. Of these, the highest proportion of non-adherence among those without financial hardship was shown in breathing problems disease (37%), and least was in cancer (19%). Among those with financial hardship, non-adherence increased significantly (listed from the highest increase to lowest) to 41% for cancer, 40% for heart disease, 48% for diabetes, 45% for arthritis, 50% for obesity, and 44% for stroke. Of the four personality types, Experiencers had the highest rate of non-adherence and Traditionalists were the lowest in all disease types regardless of financial hardship. Logistic regression models showed that disease type, financial hardship, and personality type all affected the likelihood of non-adherence. cOnclusiOns: In addition to acknowledging disease and treatment characteristics, financial hardship and personality type are important considerations for improving adherence to medications.

Investigative Ophthalmology & Visual Science, 2014

Investigative Ophthalmology & Visual Science, 2013

Investigative Ophthalmology & Visual Science, 2012

Depaul Law Review, 2020

Clinical trials are increasingly using sensors embedded in wearable devices due to their capabili... more Clinical trials are increasingly using sensors embedded in wearable devices due to their capabilities to generate real-world data. These devices are able to continuously monitor, record, and store physiological metrics in response to a given therapy, which is contributing to a redesign of clinical trials around the world. Traditional clinical trials are immensely expensive and limited in testing options, as they typically entail research participants coming to designated sites for measuring responses to an investigational treatment. This process creates a costly, time-intensive pathway from discovery to market and may not produce results that future patients wish to know, particularly around improvements in activities of daily living and overall quality of life. While wearable devices present potential benefits, including a reduction in expense

Investigative Ophthalmology & Visual Science, 2015

Investigative Ophthalmology & Visual Science, 2015

Investigative Ophthalmology & Visual Science, 2012

Investigative Ophthalmology & Visual Science, 2013

Studies in Health Technology and Informatics, 2021

Hemophilia is a rare inherited bleeding disorder characterized by the blood’s inability to clot a... more Hemophilia is a rare inherited bleeding disorder characterized by the blood’s inability to clot and could result in potentially life-threatening spontaneous bleeding into joints, organs, and tissues. Moreover, long-term management of this chronic disease is complex and costly. Current scientific evidence demonstrates that personalized digital health technologies could promote and facilitate the self-management of chronic diseases. This study introduces HemPHL a Personal Health Library and mHealth Recommender platform to gather, manage, and exchange tailored health information and recommendations to facilitate self-management and home therapy among individuals with hemophilia. The proposed digital health solution will adopt novel data science, artificial intelligence tools and techniques to manage and use information, as well as promote best practices for health education to enable patients to make informed decisions about their health. To accomplish this, an array of complex health ...

Optometry and Vision Science, 2021

SIGNIFICANCE Multiple vision-related quality of life (VRQoL) instruments exist, but questionnaire... more SIGNIFICANCE Multiple vision-related quality of life (VRQoL) instruments exist, but questionnaires designed specifically for myopic children that are appropriate for assessing the impact of refractive error are rare. PURPOSE To assess the validity and reliability of the Student Refractive Error and Eyeglasses Questionnaire - Revised (SREEQ-R) in school-aged children with myopia in United Kingdom, UK. METHODS Community optometrists in UK invited children up to the age of 18 years presenting for an eye examination with current or previous reported use of eyeglasses for myopia to complete the SREEQ-R, which consists of 20 specific items divided into two sections each with 3 response categories. The "Without Glasses" section relates to perceptions of uncorrected vision/not wearing glasses and the "With Glasses" with corrected vision/wearing glasses. Rasch analysis was used to explore the psychometric performance (Content, construct validity and reliability) of the questionnaire items and scale using WINSTEPS software. RESULTS A total of 125 eligible children with a mean age of 12.7 ± 2.9 years completed the SREEQ-R. All items fit the Rasch model and were retained and the scale was found to be unidimensional. All children and item Infit and Outfit MNSQs fell within recommended fit criteria. As per the Rasch analysis, the person reliability coefficient was 0.84 and 0.91, while item reliability was 0.99 and 0.80 for the Without Glasses and With Glasses sections, respectively. The internal consistency for the SREEQ-R was good; Cronbach alpha for the Without glasses-0.84 and With Glasses- 0.91. CONCLUSIONS The SREEQ-R had satisfactory validity and reliability evidence. Construct validity of the scale was supported to measure the impact of uncorrected and corrected refractive error on VRQoL in myopic school-aged children in United Kingdom. The SREEQ-R could be used in future studies to evaluate VRQoL in children with myopia."

Value in Health, Oct 1, 2017

A773 and may differ in surgical site infection (SSI) risk. This study aims to explore the use of ... more A773 and may differ in surgical site infection (SSI) risk. This study aims to explore the use of value of information methods to assess if a new RCT is a cost-effective use of resources, to compare the value of different study designs, and compare results with standard sample size calculations. Methods: We develop a simple decision tree model to compare the costs and quality of life resulting from different wound dressing types, which may differ in SSI risk. We use results from a network metaanalysis to inform the relative efficacy of the different dressing types. Expected Value of Sample Information (EVSI) is computed to evaluate the value of reducing uncertainty by running an RCT for various included interventions and sample size. Population EVSI is presented for 1.208m wounds over a 5-year time horizon. We compare the results with those from standard sample size calculations. Results: There was considerable uncertainty as to which dressing type is the most costeffective. Population EVSI indicates that an RCT comparing dressings is likely to be of value and that designs that compare Simple Dressings vs Glue have much higher value than designs that do not make this comparison. Balanced designs comparing Simple Dressings vs Glue vs Exposed have population EVSI of £1515m, £2057m, and £2150m for total sample sizes of 500, 2500, 5000 resp. Standard sample size calculations suggest a much larger sample (around 25000). ConClusions: We discuss possible reasons for obtaining a smaller sample size with the value of information approach compared to standard sample size calculations and implications for trial design.

Value in Health, May 1, 2020

Journal of Patient-Reported Outcomes

Background There is interest in participants using their own smartphones or tablets (“bring your ... more Background There is interest in participants using their own smartphones or tablets (“bring your own device”; BYOD) to complete patient-reported outcome (PRO) measures in clinical studies. Our study aimed to qualitatively evaluate participants’ experience using a provisioned device (PD) versus their own smartphone (BYOD) for this purpose. Methods Participants with chronic obstructive pulmonary disease (COPD) were recruited for this observational, cross-over study and completed PRO measures daily on one device type for 15 days, then switched to the other device type to complete the same measures for another 15 days. After each 15-day period, semi-structured interviews were conducted about their experience with the device. Results Of 64 participants enrolled, the final qualitative analysis populations comprised those who participated in an interview without protocol violations. Thus, the qualitative longitudinal population (LP) included n = 57 (89%), while the qualitative cross-sectio...

Therapeutic Innovation & Regulatory Science, 2022

Implementing clinical outcome assessments electronically in clinical studies requires the sponsor... more Implementing clinical outcome assessments electronically in clinical studies requires the sponsor and electronic clinical outcome assessment (eCOA) provider to work closely together to implement study-specific requirements and ensure consensus-defined best practices are followed. One of the most important steps is for sponsors to conduct user acceptance testing (UAT) using an eCOA system developed by the eCOA provider. UAT provides the clinical study team including sponsor or designee an opportunity to evaluate actual software performance and ensure that the sponsor’s intended requirements were communicated clearly and accurately translated into the system design, and that the system conforms to a sponsor-approved requirements document based on the study protocol. The components of an eCOA system, such as the study-specific application, customization features, study portal, and custom data transfers should be tested during UAT. While the provider will perform their own system valida...

Value in Health, 2017

A679 detail for evidence of SARs. A SAR was any unfavourable/unintended observation including sid... more A679 detail for evidence of SARs. A SAR was any unfavourable/unintended observation including side effects recorded in the EPR whether or not considered to be product-related and that occurred within 31 days of first glucocorticoid treatment. Results: Overall, 28,472 dogs received at least one systemic glucocorticoid during 2013 (6.2% of study dogs, 95%CI 6.2-6.3) with 30,570 oral (60.0% of total) and 20,606 injectable (40% of total) glucocorticoid events. Prednisolone represented the most frequently used oral preparation (27,362 events (90.0%)) and dexamethasone preparations were the most common injectable therapeutic (19,671 events (96.4%)). After detailed review of the EPR from the random selection of 2,110 dogs receiving systemic glucocorticoids, 106 dogs (5.0%, 95% CI 4.1-6.0%) had a total of 169 SARs recorded. The most frequent of these were polydipsia (38 events, 22.5%), polyuria (27, 16.0%), vomiting (19, 11.2%), diarrhoea (16, 9.5%) and polyphagia (15, 8.9%). In 34 (20.1%) of these events the dose of the glucocorticoid was subsequently reduced whilst in 15 (8.9%) the therapy was discontinued. ConClusions: Systemic glucocorticoid therapy was a frequent treatment in dogs attending primary-care practice, with a clinically relevant minority experiencing at least one SAR. This is a conservative quantification as only the SARS that were reported or identified by the veterinarian were included in the study.

Value in Health, 2017

Objectives: Medication adherence has been shown to be associated with the nature of the disease b... more Objectives: Medication adherence has been shown to be associated with the nature of the disease being treated and characteristics of the prescribed treatment. Non-adherence typically ranges between 30-50% of all patients. In addition, patients' beliefs about health and illness and their behavioral expressions of their personality types may be important contributors to medication adherence. The objective of this study was to describe the associations between disease type, financial hardship and four personality temperaments (Traditionalists, Experiencers, Idealists, Conceptualizers) with self-reported medication adherence. MethOds: Data were collected from the 2015 National Consumer Survey of the Medication Experience and Pharmacists' Roles, via an on-line, self-administered survey coordinated by Qualtrics Panels in the United State of America, between April 28, 2015, and June 22, 2015. Data were analyzed using IMB/SPSS version 24.0 software. Logistic regression analysis and descriptive statistics were used. Results: Out of 26,173 responses, 12,195 were taking at least one prescription medication and were not a licensed health professional, making them eligible for this study. Of these, the highest proportion of non-adherence among those without financial hardship was shown in breathing problems disease (37%), and least was in cancer (19%). Among those with financial hardship, non-adherence increased significantly (listed from the highest increase to lowest) to 41% for cancer, 40% for heart disease, 48% for diabetes, 45% for arthritis, 50% for obesity, and 44% for stroke. Of the four personality types, Experiencers had the highest rate of non-adherence and Traditionalists were the lowest in all disease types regardless of financial hardship. Logistic regression models showed that disease type, financial hardship, and personality type all affected the likelihood of non-adherence. cOnclusiOns: In addition to acknowledging disease and treatment characteristics, financial hardship and personality type are important considerations for improving adherence to medications.

Investigative Ophthalmology & Visual Science, 2014

Investigative Ophthalmology & Visual Science, 2013

Investigative Ophthalmology & Visual Science, 2012

Depaul Law Review, 2020

Clinical trials are increasingly using sensors embedded in wearable devices due to their capabili... more Clinical trials are increasingly using sensors embedded in wearable devices due to their capabilities to generate real-world data. These devices are able to continuously monitor, record, and store physiological metrics in response to a given therapy, which is contributing to a redesign of clinical trials around the world. Traditional clinical trials are immensely expensive and limited in testing options, as they typically entail research participants coming to designated sites for measuring responses to an investigational treatment. This process creates a costly, time-intensive pathway from discovery to market and may not produce results that future patients wish to know, particularly around improvements in activities of daily living and overall quality of life. While wearable devices present potential benefits, including a reduction in expense

Investigative Ophthalmology & Visual Science, 2015

Investigative Ophthalmology & Visual Science, 2015

Investigative Ophthalmology & Visual Science, 2012

Investigative Ophthalmology & Visual Science, 2013

Studies in Health Technology and Informatics, 2021

Hemophilia is a rare inherited bleeding disorder characterized by the blood’s inability to clot a... more Hemophilia is a rare inherited bleeding disorder characterized by the blood’s inability to clot and could result in potentially life-threatening spontaneous bleeding into joints, organs, and tissues. Moreover, long-term management of this chronic disease is complex and costly. Current scientific evidence demonstrates that personalized digital health technologies could promote and facilitate the self-management of chronic diseases. This study introduces HemPHL a Personal Health Library and mHealth Recommender platform to gather, manage, and exchange tailored health information and recommendations to facilitate self-management and home therapy among individuals with hemophilia. The proposed digital health solution will adopt novel data science, artificial intelligence tools and techniques to manage and use information, as well as promote best practices for health education to enable patients to make informed decisions about their health. To accomplish this, an array of complex health ...

Optometry and Vision Science, 2021

SIGNIFICANCE Multiple vision-related quality of life (VRQoL) instruments exist, but questionnaire... more SIGNIFICANCE Multiple vision-related quality of life (VRQoL) instruments exist, but questionnaires designed specifically for myopic children that are appropriate for assessing the impact of refractive error are rare. PURPOSE To assess the validity and reliability of the Student Refractive Error and Eyeglasses Questionnaire - Revised (SREEQ-R) in school-aged children with myopia in United Kingdom, UK. METHODS Community optometrists in UK invited children up to the age of 18 years presenting for an eye examination with current or previous reported use of eyeglasses for myopia to complete the SREEQ-R, which consists of 20 specific items divided into two sections each with 3 response categories. The "Without Glasses" section relates to perceptions of uncorrected vision/not wearing glasses and the "With Glasses" with corrected vision/wearing glasses. Rasch analysis was used to explore the psychometric performance (Content, construct validity and reliability) of the questionnaire items and scale using WINSTEPS software. RESULTS A total of 125 eligible children with a mean age of 12.7 ± 2.9 years completed the SREEQ-R. All items fit the Rasch model and were retained and the scale was found to be unidimensional. All children and item Infit and Outfit MNSQs fell within recommended fit criteria. As per the Rasch analysis, the person reliability coefficient was 0.84 and 0.91, while item reliability was 0.99 and 0.80 for the Without Glasses and With Glasses sections, respectively. The internal consistency for the SREEQ-R was good; Cronbach alpha for the Without glasses-0.84 and With Glasses- 0.91. CONCLUSIONS The SREEQ-R had satisfactory validity and reliability evidence. Construct validity of the scale was supported to measure the impact of uncorrected and corrected refractive error on VRQoL in myopic school-aged children in United Kingdom. The SREEQ-R could be used in future studies to evaluate VRQoL in children with myopia."

Value in Health, Oct 1, 2017

A773 and may differ in surgical site infection (SSI) risk. This study aims to explore the use of ... more A773 and may differ in surgical site infection (SSI) risk. This study aims to explore the use of value of information methods to assess if a new RCT is a cost-effective use of resources, to compare the value of different study designs, and compare results with standard sample size calculations. Methods: We develop a simple decision tree model to compare the costs and quality of life resulting from different wound dressing types, which may differ in SSI risk. We use results from a network metaanalysis to inform the relative efficacy of the different dressing types. Expected Value of Sample Information (EVSI) is computed to evaluate the value of reducing uncertainty by running an RCT for various included interventions and sample size. Population EVSI is presented for 1.208m wounds over a 5-year time horizon. We compare the results with those from standard sample size calculations. Results: There was considerable uncertainty as to which dressing type is the most costeffective. Population EVSI indicates that an RCT comparing dressings is likely to be of value and that designs that compare Simple Dressings vs Glue have much higher value than designs that do not make this comparison. Balanced designs comparing Simple Dressings vs Glue vs Exposed have population EVSI of £1515m, £2057m, and £2150m for total sample sizes of 500, 2500, 5000 resp. Standard sample size calculations suggest a much larger sample (around 25000). ConClusions: We discuss possible reasons for obtaining a smaller sample size with the value of information approach compared to standard sample size calculations and implications for trial design.