Impact of the COVID‐19 pandemic on recruitment to clinical research studies in rheumatology

Mirza, Mehboob; Siebert, Stefan; Pratt, Arthur G.; Insch, Elspeth; McIntosh, Frances; Paton, John; Wright, Claire; Buckley, Christopher D.; Isaacs, John D.; McInnes, Iain B.; Raza, Karim; Falahee, Marie

doi:10.1002/msc.1561

Cited by 30 publications

(27 citation statements)

References 18 publications

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“…We also note the relatively low proportions of CARE participants who self‐reported ADRD (9.4%) or are caregivers (11.0%, including caregivers for someone with ADRD). The COVID‐19 pandemic likely exacerbated existing barriers to research recruitment 47,48 . On the ground, the pandemic has resulted in fewer in‐person outreach and recruitment activities where we can interact directly in real time with individuals interested in CARE.…”

Section: Discussionmentioning

confidence: 99%

The Collaborative Approach for Asian Americans and Pacific Islanders Research and Education (CARE): A recruitment registry for Alzheimer's disease and related dementias, aging, and caregiver‐related research

Park

Meyer

Tsoh

et al. 2022

Alzheimer's & Dementia

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Introduction Clinical research focused on aging, Alzheimer's disease and related dementias (ADRD), and caregiving often does not recruit Asian Americans and Pacific Islanders (AAPIs). Methods With funding from the National Institute on Aging, we designed and launched the Collaborative Approach for AAPIs Research and Education (CARE), a research recruitment registry to increase AAPIs’ participation in ADRD, aging, and caregiving research. We present the design of this novel recruitment program. Results CARE uses community‐based participatory research methods that are culturally and linguistically appropriate. Since CARE's launch, it has enrolled >7000 AAPIs in a 1‐year period. The majority enrolled in CARE via community organizations and reported never having participated in any kind of research before. CARE also engages researchers by establishing a recruitment referral request protocol. Discussion CARE provides a promising venue to foster meaningful inclusion of AAPIs who are under‐represented in aging and dementia‐related research.

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Section: Discussionmentioning

confidence: 99%

The Collaborative Approach for Asian Americans and Pacific Islanders Research and Education (CARE): A recruitment registry for Alzheimer's disease and related dementias, aging, and caregiver‐related research

Park

Meyer

Tsoh

et al. 2022

Alzheimer's & Dementia

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“…We believe the low recruitment rate resulted from the effects of the COVID-19 pandemic on patient participation in the clinic. Previous studies [17][18][19] have examined the difficulties resulting from the pandemic on clinic trial recruitment. In addition, there appears to be a Hawthorne effect for our study cohort.…”

Section: Discussionmentioning

confidence: 99%

A Randomized Controlled Trial Comparing Telemedicine Versus In-Person Office Visits for the Follow-Up of Overactive Bladder

Mossack

Inoyatov

Fonseca

et al. 2022

Female Pelvic Med Reconstr Surg

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IMPORTANCEOveractive bladder is a condition that may be ideally suited for the use of telemedicine because initial treatment options are behavioral modification and pharmacotherapy.OBJECTIVEWe sought to evaluate if there was an overall difference in patient follow-up rates between telemedicine and in-person visits.STUDY DESIGNNew patients presenting with overactive bladder from July 2020 to March 2021 were randomized into telemedicine and in-person visits groups. A prospective database was maintained to compare follow-up rates, satisfaction rates, and time commitment.RESULTSForty-eight patients were randomized, 23 to the telemedicine group and 25 to the in-person visits group. There was no significant difference in follow-up rates between the telemedicine and in-person follow-up groups at 30 days (39% vs 28%, P = 0.41), 60-days (65% vs 56% P = 0.51) or 90 days (78% vs 60%, P = 0.17). There was no significant difference in satisfaction rates between the 2 groups. There was a significant difference between the average telemedicine visit time and in-person visit time (12.1 ± 6.9 minutes vs 22.8 ± 17.1 minutes; P = 0.02). For in-person visits, the average travel time was 49 minutes (interquartile range, 10–90 minutes) and average miles traveled was 22.1 miles (interquartile range, 10–70 miles).CONCLUSIONSThere was no significant difference in follow-up or satisfaction rates between telemedicine and in-person visits. Telemedicine visits took half the length of time compared with in-person visits. On average, patients in the telemedicine group saved approximately 1 hour per follow-up visit. Telemedicine visits save both the health care provider and patient significant amounts of time without sacrificing patient satisfaction and follow-up rates.

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“…It is reported by several authors that the willingness to participate in clinical trials during COVID-19 pandemic decreased up to 10–20%; some were closed because of insufficient sample sizes. 35 36 Nevertheless, further investigations of the remaining families of our cohort are to be implemented. An additional limitation of our study is that we have not yet been able to reclassify novel genetic variants; therefore, we need future functional experiments of candidate genes in vitro.…”

Section: Discussionmentioning

confidence: 99%

Co-segregation analysis and functional trial in vivo of candidate genes for monogenic diabetes

Stankutė

Kazlauskiene

Blouin

et al. 2022

BMJ Open Diab Res Care

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IntroductionThe aim of this study was to perform familial co-segregation analysis and functional trial in vivo during mixed meal tolerance test (MMTT) of novel variants in diabetes candidate genes.Research design and methodsIt is a continuation of the project “Genetic diabetes in Lithuania” with the cohort of 1209 patients with diabetes. Prior screening for autoimmune markers confirmed type 1 diabetes (T1D) diagnosis in 88.1% (n=1065) of patients, and targeted next-generation sequencing identified 3.5% (n=42) pathogenic variants in MODY genes. Subsequently, 102 patients were classified as having diabetes of unknown etiology. 12/102 were found to have novel variants in potential diabetes genes (RFX2,RREB1,SLC5A1(3 patients with variants in this gene),GCKR,MC4R,CASP10,TMPRSS6,HGFAC,DACH1,ZBED3). Co-segregation analysis and MMTT were carried out in order to study beta-cell function in subjects with specific variants.ResultsMMTT analysis showed that probands with variants inMC4R,CASP10,TMPRSS6,HGFAC, andSLC5A1(c.1415T>C) had sufficient residual beta-cell function with stimulated C-peptide (CP) >200 pmol/L. Seven individuals with variants inRFX2,RREB1,GCKR,DACH1,ZBED3andSLC5A1(c.1415T>C, and c.932A>T) presented with complete beta-cell failure. No statistical differences were found between patients with sufficient CP production and those with complete beta-cell failure when comparing age at the onset and duration of diabetes. Nineteen family members were included in co-segregation analysis; no diabetes cases were reported among them. Only in patient with the variant c.1894G>A inRFX2gene, none of the family members were affected by proband’s variant.ConclusionsFunctional beta-cell study in vivo allowed to select five most probable genes for monogenic diabetes. Familial co-segregation analysis showed that novel variant inRFX2gene could be a possible cause of diabetes. Future functional analysis in vitro is necessary to support or rule out the genetic background as a cause of diabetes.

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Impact of the COVID‐19 pandemic on recruitment to clinical research studies in rheumatology

Cited by 30 publications

References 18 publications

The Collaborative Approach for Asian Americans and Pacific Islanders Research and Education (CARE): A recruitment registry for Alzheimer's disease and related dementias, aging, and caregiver‐related research

The Collaborative Approach for Asian Americans and Pacific Islanders Research and Education (CARE): A recruitment registry for Alzheimer's disease and related dementias, aging, and caregiver‐related research

A Randomized Controlled Trial Comparing Telemedicine Versus In-Person Office Visits for the Follow-Up of Overactive Bladder

Co-segregation analysis and functional trial in vivo of candidate genes for monogenic diabetes

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