User login
WASHINGTON –
With dry eye found in over 85% of Sjogren’s patients, pinpointing important outcomes accurately can help researchers and physicians focus their efforts and be more cost effective when developing clinical trials, systematic reviews , practice guidelines, and evidence-based health care, according to presenter Ian J. Saldanha, MBBS, MPH, PhD, of the department of epidemiology at Johns Hopkins, Baltimore.
“When designing clinical trials, if you are trying to incorporate the views of patients, this can help more accurately depict what you should be measuring and in what time frame,“ Dr. Saldanha said to attendees. This can be important as agencies such as the Food and Drug Administration have absolved to be more committed to bringing the patient perspective to drug development, according to Dr. Saldanha.
Investigators surveyed 420 subscribers to KeratoScoop, a news source that specifically reports on dry eye, using a two-round survey process with participants ranking outcomes from 0 to 10, 0 being the least important and 10 being the most.
The majority of the patients were white American women, aged 50 years and older.
To start, Dr. Saldanha and his fellow investigators identified 109 outcomes commonly found in existing research. Of these, 28 were identified as important to survey takers.
The investigators noted that 39% of the outcomes identified were symptoms, compared with 25% for clinical testing, 14% related to quality of life, and the remainder split evenly between lab measures, safety, and others.
When ranked, the top 10 outcomes chosen were ocular burning, ocular discomfort, ocular pain, ocular dryness, visual acuity, overall assessment of surface symptoms, ocular foreign body sensation, tear film stability, artificial tear use, and adverse events.
Of the 28 outcomes deemed “important” by the surveyed population, 10 were found to be uncommon in current research.
When asked when patients would like these outcomes to be measured if they were to participate in a clinical trial, over 75% preferred a 3-month period for ocular burning, discomfort, pain, and foreign body sensations, as well as impact of dry eye in daily life, tear film stability, and costs of treatment. In comparison, a majority of patients agreed that outcomes such as satisfaction of treatment, ocular fatigue, and vision-related quality of life should be measured between 3 and 6 months.
With these data, according to Dr. Saldanha, researchers can maximize consistency across trials as well as contribute to better evidence-based medicine.
“This is useful for the next step, which would be to develop core outcome sets, which are an agreed upon minimum set of outcomes that should be examined in a given disease area,” Dr. Saldanha explained.
Dr. Saldanha reported no relevant financial disclosures. The meeting was sponsored by Johns Hopkins University and the National Institutes of Health.
SOURCE: Saldanha I et al. International Symposium on Sjogren’s Syndrome.
WASHINGTON –
With dry eye found in over 85% of Sjogren’s patients, pinpointing important outcomes accurately can help researchers and physicians focus their efforts and be more cost effective when developing clinical trials, systematic reviews , practice guidelines, and evidence-based health care, according to presenter Ian J. Saldanha, MBBS, MPH, PhD, of the department of epidemiology at Johns Hopkins, Baltimore.
“When designing clinical trials, if you are trying to incorporate the views of patients, this can help more accurately depict what you should be measuring and in what time frame,“ Dr. Saldanha said to attendees. This can be important as agencies such as the Food and Drug Administration have absolved to be more committed to bringing the patient perspective to drug development, according to Dr. Saldanha.
Investigators surveyed 420 subscribers to KeratoScoop, a news source that specifically reports on dry eye, using a two-round survey process with participants ranking outcomes from 0 to 10, 0 being the least important and 10 being the most.
The majority of the patients were white American women, aged 50 years and older.
To start, Dr. Saldanha and his fellow investigators identified 109 outcomes commonly found in existing research. Of these, 28 were identified as important to survey takers.
The investigators noted that 39% of the outcomes identified were symptoms, compared with 25% for clinical testing, 14% related to quality of life, and the remainder split evenly between lab measures, safety, and others.
When ranked, the top 10 outcomes chosen were ocular burning, ocular discomfort, ocular pain, ocular dryness, visual acuity, overall assessment of surface symptoms, ocular foreign body sensation, tear film stability, artificial tear use, and adverse events.
Of the 28 outcomes deemed “important” by the surveyed population, 10 were found to be uncommon in current research.
When asked when patients would like these outcomes to be measured if they were to participate in a clinical trial, over 75% preferred a 3-month period for ocular burning, discomfort, pain, and foreign body sensations, as well as impact of dry eye in daily life, tear film stability, and costs of treatment. In comparison, a majority of patients agreed that outcomes such as satisfaction of treatment, ocular fatigue, and vision-related quality of life should be measured between 3 and 6 months.
With these data, according to Dr. Saldanha, researchers can maximize consistency across trials as well as contribute to better evidence-based medicine.
“This is useful for the next step, which would be to develop core outcome sets, which are an agreed upon minimum set of outcomes that should be examined in a given disease area,” Dr. Saldanha explained.
Dr. Saldanha reported no relevant financial disclosures. The meeting was sponsored by Johns Hopkins University and the National Institutes of Health.
SOURCE: Saldanha I et al. International Symposium on Sjogren’s Syndrome.
WASHINGTON –
With dry eye found in over 85% of Sjogren’s patients, pinpointing important outcomes accurately can help researchers and physicians focus their efforts and be more cost effective when developing clinical trials, systematic reviews , practice guidelines, and evidence-based health care, according to presenter Ian J. Saldanha, MBBS, MPH, PhD, of the department of epidemiology at Johns Hopkins, Baltimore.
“When designing clinical trials, if you are trying to incorporate the views of patients, this can help more accurately depict what you should be measuring and in what time frame,“ Dr. Saldanha said to attendees. This can be important as agencies such as the Food and Drug Administration have absolved to be more committed to bringing the patient perspective to drug development, according to Dr. Saldanha.
Investigators surveyed 420 subscribers to KeratoScoop, a news source that specifically reports on dry eye, using a two-round survey process with participants ranking outcomes from 0 to 10, 0 being the least important and 10 being the most.
The majority of the patients were white American women, aged 50 years and older.
To start, Dr. Saldanha and his fellow investigators identified 109 outcomes commonly found in existing research. Of these, 28 were identified as important to survey takers.
The investigators noted that 39% of the outcomes identified were symptoms, compared with 25% for clinical testing, 14% related to quality of life, and the remainder split evenly between lab measures, safety, and others.
When ranked, the top 10 outcomes chosen were ocular burning, ocular discomfort, ocular pain, ocular dryness, visual acuity, overall assessment of surface symptoms, ocular foreign body sensation, tear film stability, artificial tear use, and adverse events.
Of the 28 outcomes deemed “important” by the surveyed population, 10 were found to be uncommon in current research.
When asked when patients would like these outcomes to be measured if they were to participate in a clinical trial, over 75% preferred a 3-month period for ocular burning, discomfort, pain, and foreign body sensations, as well as impact of dry eye in daily life, tear film stability, and costs of treatment. In comparison, a majority of patients agreed that outcomes such as satisfaction of treatment, ocular fatigue, and vision-related quality of life should be measured between 3 and 6 months.
With these data, according to Dr. Saldanha, researchers can maximize consistency across trials as well as contribute to better evidence-based medicine.
“This is useful for the next step, which would be to develop core outcome sets, which are an agreed upon minimum set of outcomes that should be examined in a given disease area,” Dr. Saldanha explained.
Dr. Saldanha reported no relevant financial disclosures. The meeting was sponsored by Johns Hopkins University and the National Institutes of Health.
SOURCE: Saldanha I et al. International Symposium on Sjogren’s Syndrome.
REPORTING FROM ISSS
Key clinical point: Investigators have identified core outcomes important to Sjogren’s patients with dry eye.
Major finding: Out of 28 outcomes identified, 39% were symptoms and 36% have not been commonly included in existing research.
Study details: An anonymous, two-round Delphi survey of 420 subscribers to KeratoScoop between November and December, 2017.
Disclosures: The presenter reported no relevant financial disclosures.
Source: Saldanha I et al. International Symposium on Sjogren’s Syndrome.