scholarly journals Underrepresentation of Adults and Older Adults With Disabilities in Behavioral Clinical Trials: A Scoping Review

2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 644-644
Author(s):  
Susan Stark ◽  
Marian Keglovits ◽  
Sandra Espín Tello

Abstract A lack of evidence-based interventions for people aging with long-term physical disabilities exists. To examine the exclusion of people with disabilities in behavioral clinical trials, a scoping review was conducted. ClinicalTrials.gov was searched for interventional behavioral studies from the United States completed from 2008–2018, with results focused on adults (18–64) and older adults (65+). In total, 158 clinical trials were included. In 129 articles, health conditions were excluded 697 times. Seventy-one clinical trials excluded at least one health condition with strong justification, 11 with poor justification, and 115 without justification. There is strong evidence that people with disabilities are excluded from behavioral clinical trials, often without justification. To help close this gap, our presentation will discuss how translational research strategies, focused on adapting existing EB behavioral trials, can be used to increase the availability of interventions that address the needs of individuals aging with and into long-term disabilities. Part of a symposium sponsored by the Lifelong Disabilities Interest Group.

Author(s):  
Melissa A. Pierce

In countries other than the United States, the study and practice of speech-language pathology is little known or nonexistent. Recognition of professionals in the field is minimal. Speech-language pathologists in countries where speech-language pathology is a widely recognized and respected profession often seek to share their expertise in places where little support is available for individuals with communication disorders. The Peace Corps offers a unique, long-term volunteer opportunity to people with a variety of backgrounds, including speech-language pathologists. Though Peace Corps programs do not specifically focus on speech-language pathology, many are easily adapted to the profession because they support populations of people with disabilities. This article describes how the needs of local children with communication disorders are readily addressed by a Special Education Peace Corps volunteer.


2019 ◽  
Author(s):  
Allison Hirsch ◽  
Mahip Grewal ◽  
Anthony James Martorell ◽  
Brian Michael Iacoviello

BACKGROUND Digital Therapeutics (DTx) provide evidence based therapeutic health interventions that have been clinically validated to deliver therapeutic outcomes, such that the software is the treatment. Digital methodologies are increasingly adopted to conduct clinical trials due to advantages they provide including increases in efficiency and decreases in trial costs. Digital therapeutics are digital by design and can leverage the potential of digital and remote clinical trial methods. OBJECTIVE The principal purpose of this scoping review is to review the literature to determine whether digital technologies are being used in DTx clinical research, which type are being used and whether publications are noting any advantages to their use. As DTx development is an emerging field there are likely gaps in the knowledge base regarding DTx and clinical trials, and the purpose of this review is to illuminate those gaps. A secondary purpose is to consider questions which emerged during the review process including whether fully remote digital clinical research is appropriate for all health conditions and whether digital clinical trial methods are inline with the principles of Good Clinical Practice. METHODS 1,326 records were identified by searching research databases and 1,227 reviewed at the full-article level in order to determine if they were appropriate for inclusion. Confirmation of clinical trial status, use of digital clinical research methods and digital therapeutic status as well as inclusion and exclusion criteria were applied in order to determine relevant articles. Digital methods employed in DTx research were extracted from each article and these data were synthesized in order to determine which digital methods are currently used in clinical trial research. RESULTS After applying our criteria for scoping review inclusion, 11 articles were identified. All articles used at least one form of digital clinical research methodology enabling an element of remote research. The most commonly used digital methods are those related to recruitment, enrollment and the assessment of outcomes. A small number of articles reported using other methods such as online compensation (n = 3), or digital reminders for participants (n = 5). The majority of digital therapeutics clinical research using digital methods is conducted in the United States and increasing number of articles using digital methods are published each year. CONCLUSIONS Digital methods are used in clinical trial research evaluating DTx, though not frequently as evidenced by the low proportion of articles included in this review. Fully remote clinical trial research is not yet the standard, more frequently authors are using partially remote methods. Additionally, there is tremendous variability in the level of detail describing digital methods within the literature. As digital technologies continue to advance and the clinical research DTx literature matures, digital methods which facilitate remote research may be used more frequently.


2021 ◽  
pp. 002216782110236
Author(s):  
Julie B. Wang ◽  
Jessica Lin ◽  
Leah Bedrosian ◽  
Allison Coker ◽  
Ilsa Jerome ◽  
...  

Background: Posttraumatic stress disorder (PTSD) is a debilitating mental health condition associated with serious adverse health outcomes and functional impairment. Previous MDMA–assisted therapy (MDMA-AT) studies have shown promising results in single site studies. Two open-label studies tested this modality in multisite clinical trials to assess the feasibility of scaling this manualized therapy across 14 North American sites. Method: Cotherapist dyads were trained in the manualized MDMA-AT protocol and administered three experimental sessions 3 to 5 weeks apart among participants with severe PTSD. Cotherapist dyads were provided clinical supervision and evaluated for protocol adherence by centralized raters. Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) assessed change in symptoms severity. Results: Adherence rating scores were high across cotherapist dyads ( M = 95.08%, SD = 3.70%) and sites ( M = 95.23%, SD = 2.20%). CAPS-5 scores decreased following 3 MDMA-AT sessions at 18 weeks post baseline (Δ M = −29.99, Δ SD = 13.45, p < .0001, n = 37, Cohen’s d = 2.2, confidence interval [1.97, 2.47]). MDMA was well tolerated. Conclusions: These findings corroborate previous results that MDMA-AT can achieve significant improvements in PTSD symptom severity and demonstrate scalability of manualized therapy across clinic sites in the United States and Canada.


2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 704-704
Author(s):  
Yuchi Young ◽  
Barbara Resnick

Abstract The world population is aging. The proportion of the population over 60 will nearly double from 12% in 2015 to 22% in 2050. Global life expectancy has more than doubled from 31 years in 1900 to 72.6 years in 2019. The need for long-term care (LTC) services is expanding with the same rapidity. A comprehensive response is needed to address the needs of older adults. Learning from health systems in other countries enables health systems to incorporate best long-term care practices to fit each country and its culture. This symposium aims to compare long-term care policies and services in Taiwan, Singapore, and the USA where significant growth in aging populations is evidenced. In 2025, the aging population will be 20% in Taiwan, 20% in Singapore and 18 % in the USA. In the case of Taiwan, it has moved from aging society status to aged society, and to super-aged society in 27 years. Such accelerated rate of aging in Taiwan is unparalleled when compared to European countries and the United States. In response to this dramatic change, Taiwan has passed long-term care legislation that expands services to care for older adults, and developed person-centered health care that integrates acute and long-term care services. Some preliminary results related to access, care and patterns of utilization will be shared in the symposium. International Comparisons of Healthy Aging Interest Group Sponsored Symposium.


2021 ◽  
Vol 22 (5) ◽  
pp. 589-590
Author(s):  
Kushang Patel ◽  
Zachary Marcum ◽  
Elizabeth Phelan ◽  
Bobby Jones ◽  
Sean Rundell

2020 ◽  
Vol 1;24 (1;1) ◽  
pp. 31-40

BACKGROUND: Long-term opioid therapy was prescribed with increasing frequency over the past decade. However, factors surrounding long-term use of opioids in older adults remains poorly understood, probably because older people are not at the center stage of the national opioid crisis. OBJECTIVES: To estimate the annual utilization and trends in long-term opioid use among older adults in the United States. STUDY DESIGN: Retrospective cohort study. SETTING: Data from Medicare-enrolled older adults. METHODS: This study utilized a nationally representative sample of Medicare administrative claims data from the years 2012 to 2016 containing records of health care services for more than 2.3 million Medicare beneficiaries each year. Medicare beneficiaries who were 65 years of age or older and who were enrolled in Medicare Parts A, B, and D, but not Part C, for at least 10 months in a year were included in the study. We measured annual utilization and trends in new long-term opioid use episodes over 4 years (2013–2016). We examined claims records for the demographic characteristics of the eligible individuals and for the presence of chronic non-cancer pain (CNCP), cancer, and other comorbidities. RESULTS: From 2013 to 2016, administrative claims of approximately 2.3 million elderly Medicare beneficiaries were analyzed in each year with a majority of them being women (~56%) and white (~82%) with a mean age of approximately 75 years. The proportion of all eligible beneficiaries with at least one new opioid prescription increased from 6.64% in 2013, peaked at 10.32% in 2015, and then decreased to 8.14% in 2016. The proportion of individuals with long-term opioid use among those with a new opioid prescription was 12.40% in 2013 and 10.20% in 2016. Among new long-term opioid users, the proportion of beneficiaries with a cancer diagnosis during the study years increased from 13.30% in 2013 to 15.67% in 2016, and the proportion with CNCP decreased from 30.25% in 2013 to 27.36% in 2016. Across all years, long-term opioid use was consistently high in the Southern states followed by the Midwest region. LIMITATIONS: This study used Medicare fee-for-service administrative claims data to capture prescription fill patterns, which do not allow for the capture of individuals enrolled in Medicare Advantage plans, cash prescriptions, or for the evaluation of appropriateness of prescribing, or the actual use of medication. This study only examined long-term use episodes among patients who were defined as opioid-naive. Finally, estimates captured for 2016 could only utilize data from 9 months of the year to capture 90-day long-term-use episodes. CONCLUSIONS: Using a national sample of elderly Medicare beneficiaries, we observed that from 2013 to 2016 the use of new prescription opioids increased from 2013 to 2014 and peaked in 2015. The use of new long-term prescription opioids peaked in 2014 and started to decrease from 2015 and 2016. Future research needs to evaluate the impact of the changes in new and long-term prescription opioid use on population health outcomes. KEY WORDS: Long-term, opioids, older adults, trends, Medicare, chronic non-cancer pain, cancer, cohort study


2021 ◽  
pp. 1-24
Author(s):  
Fiona Höbler ◽  
Katherine S. McGilton ◽  
Walter Wittich ◽  
Kate Dupuis ◽  
Marilyn Reed ◽  
...  

Background: Hearing loss is highly prevalent in older adults, particularly among those living with dementia and residing in long-term care homes (LTCHs). Sensory declines can have deleterious effects on functioning and contribute to frailty, but the hearing needs of residents are often unrecognized or unaddressed. Objective: To identify valid and reliable screening measures that are effective for the identification of hearing loss and are suitable for use by nursing staff providing care to residents with dementia in LTCHs. Methods: Electronic databases (Embase, Medline, PsycINFO, CENTRAL, and CINAHL) were searched using comprehensive search strategies, and a stepwise approach based on Arksey & O’Malley’s scoping review and appraisal process was followed. Results: There were 193 scientific papers included in the review. Pure-tone audiometry was the most frequently reported measure to test hearing in older adults living with dementia. However, measures including self- or other-reports and questionnaires, review of medical records, otoscopy, and the whisper test were found to be most suitable for use by nurses working with older adults living with dementia in LTCHs. Conclusion: Although frequently used, the suitability of pure-tone audiometry for use by nursing staff in LTCHs is limited, as standardized audiometry presents challenges for many residents, and specific training is needed to successfully adapt test administration procedures and interpret results. The whisper test was considered to be more suitable for use by staff in LTCH; however, it yields a limited characterization of hearing loss. There remains an urgent need to develop new approaches to screen hearing in LTCHs.


2018 ◽  
Vol 20 (3) ◽  
pp. 401-408
Author(s):  
Anamica Batra ◽  
Richard C. Palmer ◽  
Elena Bastida ◽  
H. Virginia McCoy ◽  
Hafiz M. R. Khan

Objective. In 2015, only half (48%) of older adults in the United States (≥60 years) reported engaging in any kind of physical activity. Few studies examine the impact of evidence-based programs when adopted in community-based settings. The purpose of this study is to assess the effectiveness of EnhanceFitness (EF) upto 12-months. Method. EF was offered to older adults in South Florida. A total of 222 EF classes were offered between October 2008 and December 2014. Program consisted of a 1-hour session held three times a week. Even though participation was required for 4 months, 1,295 participants continued the program for at least 1 year. Results. All participants showed significant improvement in outcome measures. A mean change of 1.5, 1.7, and 1.9 was seen in number of chair stands at 4, 8, and 12 months (p < .001), respectively. The number of arm curls performed improved from 16.8 at baseline to 18.8, 18.8, and 19.2 at 4-, 8-, and 12-months, respectively. Participants improved their up-and-go time by decreasing from 9.1 (baseline) to 8.7 (4 months) to 8.6 (12 months; p = .001). Discussion. Randomized controlled trials are commonly used to determine the efficacy of an intervention. These interventions when disseminated at the population level have the potential to benefit large masses. EF is currently offered at more than 700 locations. This tremendous success of EF brings attention to an important question of continuous monitoring of these programs to ensure program consistency and intended outcomes. The model used by the Healthy Aging Regional Collaborative could be replicated by other communities.


BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e024212 ◽  
Author(s):  
Emiko Kamitani ◽  
Adebukola H Johnson ◽  
Megan Wichser ◽  
Yuko Mizuno ◽  
Julia B DeLuca ◽  
...  

IntroductionThe research literature addressing pre-exposure prophylaxis (PrEP) has increased considerably over the last decade. To better understand the research areas and explore research gaps, we will conduct a scoping review to map study topics and describe study characteristics and populations in publications focused on PrEP. The purpose of this protocol is to describe planned methods for the scoping review.Methods and analysisWe will implement a comprehensive systematic literature search to identify PrEP citations in the United States Centres for Disease Control and Prevention HIV/AIDS Prevention Research Synthesis Project database that is unique and extensively focuses on HIV/sexually transmitted infections/hepatitis. We will screen and include studies that are (1) focused on HIV PrEP, (2) primary research with human participants and (3) published in English. Two reviewers will independently abstract data on authors’ names, study years, countries, population characteristics and design. To describe and summarise study topics, we will use 19 codes and five categories that were developed from a preliminary study. The five categories arecategory 1: potential PrEP user/prescriber(behaviours/issues for potential PrEP takers/healthcare professionals),category 2: considerations while on PrEP(experiences of and problems related to staying on or prescribing PrEP),category 3: PrEP efficacy and safety(biomedical aspects and medication efficacy),category 4: methods of and experiences with PrEP clinical trials(possesses/experiences of clinical trials) andcategory 5: cost-effectiveness or economic evaluation(cost studies). Data will be analysed with descriptive statistics.Ethics and disseminationThe findings will be presented at HIV-related conferences and published in peer-review journals.


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