When an organization, like a government agency, company, or nonprofit, considers a big change or launches a new initiative, it may ask for feedback from the public during a public comment period.
For example, the FDA posts proposed rule changes on regulations.gov, letting people read these proposals share their perspectives. Public comment periods are critical because they are one of the few opportunities for patients and advocates to influence decisions before they are finalized.
One way that Solve advocates for the ME/CFS and Long Covid community is by tracking public comment opportunities related to patient care or to research design, evaluation, and funding. By submitting comments on key initiatives, we help make sure that research and health innovation don’t happen to patients, but rather with patients.
This approach leads to better-designed studies, stronger standards of evidence, and medical tools that are more useful in real-world settings. Just this last quarter, Solve responded to three important calls for public comments.
Public comment #1: Updating guidelines for systematic reviews (NASEM)
The National Academies of Sciences, Engineering, and Medicine (NASEM) invited public comments on proposed updates to guidelines for how researchers prepare systematic reviews of the scientific literature. Systematic reviews aim to identify and evaluate relevant research on a given topic (e.g., “genetic drivers of ME/CFS” or “effectiveness of stellate ganglion block for treating people with Long Covid”) and to synthesize that evidence in a single publication.
In its comments, Solve emphasized that many systematic reviews focus on overly academic questions and produce broad conclusions that do not address the practical challenges facing patients and clinicians. For example, when making real-world treatment decisions, patients and clinicians must know how treatments may affect people with specific subgroups of patients with specific subtypes of disease, rather than reading about overly generalized conclusions with limited practical use.
To improve the relevance for systematic reviews for patients, Solve recommended the following updates:
• Encourage researchers to consult with patients early in the review process to identify high-priority, patient-generated questions and align reviews with these questions.
• Include a dedicated “Patient Experiences” section that explains in understandable terms how key findings relate to patients’ lived experiences.
• Encourage use of patient-developed tools to evaluate how well researchers engage patients in writing systematic reviews. One example would be the patient-engagement scorecards developed by the Patient-Led Research Collaborative.
• Support appropriate use of artificial intelligence for preparing systematic reviews (e.g., to prepare plain-language summaries to reach high-risk communities), while clearly documenting what parts of the review were handled by artificial intelligence and what parts handled by human experts.
Public comment #2: Improving a clinical trial on stellate ganglion block (NIH RECOVER-TLC)
The NIH RECOVER-TLC initiative called for input to improve a new clinical trial studying how stellate ganglion block may help people with Long Covid. In preparing these comments, Solve worked with Dr. Deborah Duricka (2022 Solve Ramsay Grant winner), an expert on using stellate ganglion block to help people with Long Covid or ME/CFS. Key recommendations included:
• Consider that people often feel better after getting a stellate ganglion block and thus “try to push their energy envelope.” To avoid harm, trial workers must explain that participants should avoid sudden increases in activity after treatments, regardless of how they feel. The trial should also include objective measures of physical activity and post-exertional malaise (e.g., step counts), instead of relying on subjective, self-reported surveys.
• Minimize burden for study participants, like those with post-exertional malaise or POTS, who may struggle with on-site visits to take neurocognition and OI tests and to give blood samples. Trial workers should be flexible in scheduling visits and should offer support (e.g., transportation, parking vouchers, monetary compensation, rest spaces).
• Do not unnecessarily exclude participants with common comorbidities (e.g., obesity, asthma, depression, anxiety). Because many people have these conditions alongside Long Covid, we must study treatment effects in real-world situations that include these cases.
Public comment #3: Improving patient-engagement resources (Milken Institute)
The Milken Institute called for suggestions on improving their “toolkit” of resources designed to help companies better engage patients when developing new medical devices and products.
This toolkit includes a library of case studies; examples where failure to listen to patients when developing products caused immense problems, and examples where listening to patients led to better outcomes.
Solve contributed three real-world examples from the ME/CFS and Long Covid community:
• The long delay in the medical establishment recognizing post-exertional malaise as a cardinal ME/CFS symptom, during which patients were often dismissed as having psychiatric problems or as being deconditioned because of laziness or physical inactivity.
• Research led by Dr. Shad Roundy (Solve Ramsay Grant winner) showing how posture contributes to post-exertional malaise in people with ME/CFS. Listening to patients, Dr. Roundy realized that ME/CFS and Long Covid symptoms (like light-headedness, nausea, weakness) often worsen when people are standing; and improve when they lie down.
This insight led to development of an ankle-worn device that automatically and objectively tracks posture and time spent upright, producing a low-cost, patient friendly tool that can distinguish people with ME/CFS or Long Covid and even track symptom severity in clinical trials.
• The Yale Listen to Immune, Symptom and Treatment Experiences Now (LISTEN) Study, led by Dr. Akiko Iwasaki (Solve Catalyst Award winner), in which patients regularly meet with Dr. Iwasaki and her team to discuss new findings and to guide the study’s direction. This partnership has already produced research papers about Long Covid–associated symptoms of internal tremors and vibrations and about symptoms sometimes experienced after receiving COVID-19 vaccines.
By taking advantage of these public comment opportunities, Solve is intervening upstream of these important processes, before guidelines are published, before trials launch, and before standards become locked in.
In this way, we are helping to turn the lived experiences of our patient communities into better research, better tools, and better outcomes.
Why Public Comments Matter: How Solve Protects Patients Before Policies and Trials are Set in Stone
When an organization, like a government agency, company, or nonprofit, considers a big change or launches a new initiative, it may ask for feedback from the public during a public comment period.
For example, the FDA posts proposed rule changes on regulations.gov, letting people read these proposals share their perspectives. Public comment periods are critical because they are one of the few opportunities for patients and advocates to influence decisions before they are finalized.
One way that Solve advocates for the ME/CFS and Long Covid community is by tracking public comment opportunities related to patient care or to research design, evaluation, and funding. By submitting comments on key initiatives, we help make sure that research and health innovation don’t happen to patients, but rather with patients.
This approach leads to better-designed studies, stronger standards of evidence, and medical tools that are more useful in real-world settings. Just this last quarter, Solve responded to three important calls for public comments.
Public comment #1: Updating guidelines for systematic reviews (NASEM)
The National Academies of Sciences, Engineering, and Medicine (NASEM) invited public comments on proposed updates to guidelines for how researchers prepare systematic reviews of the scientific literature. Systematic reviews aim to identify and evaluate relevant research on a given topic (e.g., “genetic drivers of ME/CFS” or “effectiveness of stellate ganglion block for treating people with Long Covid”) and to synthesize that evidence in a single publication.
In its comments, Solve emphasized that many systematic reviews focus on overly academic questions and produce broad conclusions that do not address the practical challenges facing patients and clinicians. For example, when making real-world treatment decisions, patients and clinicians must know how treatments may affect people with specific subgroups of patients with specific subtypes of disease, rather than reading about overly generalized conclusions with limited practical use.
To improve the relevance for systematic reviews for patients, Solve recommended the following updates:
• Encourage researchers to consult with patients early in the review process to identify high-priority, patient-generated questions and align reviews with these questions.
• Include a dedicated “Patient Experiences” section that explains in understandable terms how key findings relate to patients’ lived experiences.
• Encourage use of patient-developed tools to evaluate how well researchers engage patients in writing systematic reviews. One example would be the patient-engagement scorecards developed by the Patient-Led Research Collaborative.
• Support appropriate use of artificial intelligence for preparing systematic reviews (e.g., to prepare plain-language summaries to reach high-risk communities), while clearly documenting what parts of the review were handled by artificial intelligence and what parts handled by human experts.
Public comment #2: Improving a clinical trial on stellate ganglion block (NIH RECOVER-TLC)
The NIH RECOVER-TLC initiative called for input to improve a new clinical trial studying how stellate ganglion block may help people with Long Covid. In preparing these comments, Solve worked with Dr. Deborah Duricka (2022 Solve Ramsay Grant winner), an expert on using stellate ganglion block to help people with Long Covid or ME/CFS. Key recommendations included:
• Consider that people often feel better after getting a stellate ganglion block and thus “try to push their energy envelope.” To avoid harm, trial workers must explain that participants should avoid sudden increases in activity after treatments, regardless of how they feel. The trial should also include objective measures of physical activity and post-exertional malaise (e.g., step counts), instead of relying on subjective, self-reported surveys.
• Minimize burden for study participants, like those with post-exertional malaise or POTS, who may struggle with on-site visits to take neurocognition and OI tests and to give blood samples. Trial workers should be flexible in scheduling visits and should offer support (e.g., transportation, parking vouchers, monetary compensation, rest spaces).
• Do not unnecessarily exclude participants with common comorbidities (e.g., obesity, asthma, depression, anxiety). Because many people have these conditions alongside Long Covid, we must study treatment effects in real-world situations that include these cases.
Public comment #3: Improving patient-engagement resources (Milken Institute)
The Milken Institute called for suggestions on improving their “toolkit” of resources designed to help companies better engage patients when developing new medical devices and products.
This toolkit includes a library of case studies; examples where failure to listen to patients when developing products caused immense problems, and examples where listening to patients led to better outcomes.
Solve contributed three real-world examples from the ME/CFS and Long Covid community:
• The long delay in the medical establishment recognizing post-exertional malaise as a cardinal ME/CFS symptom, during which patients were often dismissed as having psychiatric problems or as being deconditioned because of laziness or physical inactivity.
• Research led by Dr. Shad Roundy (Solve Ramsay Grant winner) showing how posture contributes to post-exertional malaise in people with ME/CFS. Listening to patients, Dr. Roundy realized that ME/CFS and Long Covid symptoms (like light-headedness, nausea, weakness) often worsen when people are standing; and improve when they lie down.
This insight led to development of an ankle-worn device that automatically and objectively tracks posture and time spent upright, producing a low-cost, patient friendly tool that can distinguish people with ME/CFS or Long Covid and even track symptom severity in clinical trials.
• The Yale Listen to Immune, Symptom and Treatment Experiences Now (LISTEN) Study, led by Dr. Akiko Iwasaki (Solve Catalyst Award winner), in which patients regularly meet with Dr. Iwasaki and her team to discuss new findings and to guide the study’s direction. This partnership has already produced research papers about Long Covid–associated symptoms of internal tremors and vibrations and about symptoms sometimes experienced after receiving COVID-19 vaccines.
By taking advantage of these public comment opportunities, Solve is intervening upstream of these important processes, before guidelines are published, before trials launch, and before standards become locked in.
In this way, we are helping to turn the lived experiences of our patient communities into better research, better tools, and better outcomes.