Barriers to clinical trial enrollment of older adults with cancer: A systematic review.

e18130 Background: Despite the disproportionate impact of cancer on older adults, older patients are vastly underrepresented in clinical trials that set the standards for cancer treatment. To better understand the reasons for this disparity, we conducted a systematic review of studies that have specifically examined barriers and interventions to improve clinical trial enrollment of older adults with cancer. Methods: We conducted a comprehensive two-step search strategy. First, we consulted an information specialist to develop an electronic search for the following databases from inception to January 15, 2019: PubMed, Ovid/Medline, Embase, Scopus, PsycINFO, and Cochrane library. Second, references of retrieved key articles were screened for relevant studies. Two authors then independently reviewed all titles and abstracts (N = 10,985) and examined studies for full text eligibility (N = 221). Inclusion criteria were: 1) original research; 2) study assessed barriers and/or interventions to enrollment in oncology clinical trials; 3) included patients ≥ 60 years with cancer. Narrative reviews and abstracts without full text were excluded. Data was extracted by independent raters and summarized using a qualitative analysis software, NVivo v12. Results: 12 observational studies examining barriers and 1 randomized intervention were included. Barriers were assessed at the patient level (N = 5 studies), healthcare professional (HCP) level (N = 5), and both patient and HCP levels (N = 2). Stringent eligibility criteria (N = 7) and oncologists’ concerns for toxicity (N = 7) were the most common barriers cited. Patient barriers included transportation (N = 6), time/burden (N = 6), and awareness (N = 6). Although caregiver barriers (N = 4) were identified, none of the studies examined caregiver perceptions. One study evaluated a physician-directed educational intervention and found no significant impact on accrual of older adults. Conclusions: Although several studies have examined the barriers to accrual of older adults with cancer, only one intervention study has attempted to address these barriers. Given the aging of the cancer population, new strategies for including older adults in cancer clinical trials are critically needed.

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Biomarkers predictive of treatment response in psoriasis and psoriatic arthritis: a systematic review

Therapeutic Advances in Musculoskeletal Disease ◽

10.1177/1759720x211014010 ◽

2021 ◽

Vol 13 ◽

pp. 1759720X2110140

Author(s):

Conor Magee ◽

Hannah Jethwa ◽

Oliver M. FitzGerald ◽

Deepak R. Jadon

Keyword(s):

Systematic Review ◽

Psoriatic Arthritis ◽

Treatment Response ◽

Unmet Need ◽

Response To Treatment ◽

Cochrane Library ◽

Original Research ◽

Eligibility Criteria ◽

Psoriatic Disease ◽

Subsequent Response

Aims: The ability to predict response to treatment remains a key unmet need in psoriatic disease. We conducted a systematic review of studies relating to biomarkers associated with response to treatment in either psoriasis vulgaris (PsV) or psoriatic arthritis (PsA). Methods: A search was conducted in PubMed, Embase and the Cochrane library from their inception to 2 September 2020, and conference proceedings from four major rheumatology conferences. Original research articles studying pre-treatment biomarker levels associated with subsequent response to pharmacologic treatment in either PsV or PsA were included. Results: A total of 765 articles were retrieved and after review, 44 articles (22 relating to PsV and 22 to PsA) met the systematic review’s eligibility criteria. One study examined the response to methotrexate, one the response to tofacitinib and all the other studies to biologic disease-modifying antirheumatic drugs (DMARDs). Whilst several studies examined the HLA-C*06 allele in PsV, the results were conflicting. Interleukin (IL)-12 serum levels and polymorphisms in the IL-12B gene show promise as biomarkers of treatment response in PsV. Most, but not all, studies found that higher baseline levels of C-reactive protein (CRP) were associated with a better clinical response to treatment in patients with PsA. Conclusion: Several studies have identified biomarkers associated with subsequent response to treatment in psoriatic disease. However, due to the different types of biomarkers, treatments and outcome measures used, firm conclusions cannot be drawn. Further validation is needed before any of these biomarkers translate to clinical practice.

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Increasing underrepresented minority cancer patient enrollment into cancer clinical trials: A systematic review.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.e18574 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. e18574-e18574

Author(s):

Rosa Nouvini ◽

Patricia A. Parker ◽

Charlotte Malling ◽

Kendra Godwin ◽

Rosario Costas-Muñiz

Keyword(s):

Systematic Review ◽

Clinical Trial ◽

Clinical Trials ◽

Minority Groups ◽

Relationship Building ◽

Institutional Research ◽

Underrepresented Minority ◽

Randomized Controlled ◽

Clinical Trial Enrollment ◽

Recruitment Model

e18574 Background: Minorities continue to be underrepresented in clinical trials despite the National Institute of Health’s Revitalization Act, passed in 1993, mandating the representation of women and underrepresented minority groups in clinical trials. Studies have shown that although Blacks represent 15% and Hispanics 13% of the cancer population, their clinical trial enrollment rates in are disproportionately low at 4-6% and 3-6% respectively. We conducted a systematic review exploring interventions aimed at improving clinical trial enrollment for racial and ethnic minorities. Methods: A systematic search of PubMed, Cochrane CENTRAL, and Ovid PsycINFO was conducted for English-language studies of humans since 1993. Inclusion criteria included peer-reviewed, U.S.-based studies with interventions aimed to recruit underrepresented minority adult cancer patients into cancer clinical trials. We defined underrepresented minority groups as Black, Hispanic/Latino, Asian, American Indian/Alaska Native and Native Hawaiian/other Pacific Islander. Results: A total of 2471 titles and abstracts were identified and 2324 were excluded based on the eligibility criteria. A full text review was conducted of the remaining 147 articles, of which only 9 met criteria for our review. The interventions included patient navigation/coaching (n = 4), a clinical trial educational video (n = 2), institutional research infrastructure changes (n = 1), a relationship building and social marketing recruitment model (n = 1) and cultural competency training for providers (n = 1). Studies were conducted in a variety of practice settings including national cancer institutes and community practices. The quality of evidence was limited by the heterogeneity of study methods, patient representation and bias. Several studies had a homogeneous population of Black patients. Most studies (n = 7) were single arm trials that compared results to either historical controls or those cited in the existing literature; two studies were randomized controlled trials. A statistically significant improvement in accrual was shown in three of the patient navigation interventions, one of the clinical trial educational videos, the institutional research infrastructure change and the relationship building and social marketing recruitment model. The common threads to many of these successful interventions were support through the cancer care continuum, cultural congruency of research staff and culturally catered clinical trial educational materials. Conclusions: This systematic review illustrates several mechanisms by which to increase cancer clinical trial recruitment for cancer patients of underrepresented minority backgrounds in a variety of clinical settings. Randomized controlled trials with representation of multiple races/ethnicities are needed to further explore the benefits of these interventions.

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Sarcopenic is associated with hypertension in older adults: a systematic review and meta-analysis

10.21203/rs.2.20678/v1 ◽

2020 ◽

Author(s):

Tingting Bai ◽

Fang Fang ◽

Feika Li ◽

Yan Ren ◽

Jiaan Hu ◽

...

Keyword(s):

Systematic Review ◽

Older Adults ◽

Confidence Interval ◽

Handgrip Strength ◽

Meta Analysis ◽

Cochrane Library ◽

Original Research ◽

Inclusion Criteria ◽

Asian Group ◽

Research Studies

Abstract BackgroundBoth sarcopenia and handgrip strength have been observed association with hypertension. However, the results in different studies were inconsistent. In the current study, we conducted a systematic review and meta-analysis to reveal the association between sarcopenia, handgrip strength, and hypertension in older adults.MethodsPubMed, MEDLINE, Cochrane Library, and EMBASE databases were searched from inception to 15 November, 2019for original research studies. The studies that addressed the association between sarcopenia, handgrip strength, and hypertension were included and summarized.Results19 studies met the inclusion criteria and a total of 21301 were included in the meta-analysis. Eight eligible studiesreported the odd ratios (ORs) of hypertension and the ORs ranged from 0.41 to 4.38. When pooled the ORs together, the summarized ORs was 1.29 [95% confidence interval (CI) =1.00-1.67]. The summarized ORs for the Asian group 1.50 (95% CI=1.35-1.67) was significantly higher than that of Caucasian group 1.08 (95% CI=0.39-2.97). Eleven studies provided the data on association between handgrip strength and hypertension. The overall ORs and 95% CI was 0.99 (95% CI=0.80-1.23), showing no association.ConclusionSarcopenia was associated with hypertension but no correlation was found between handgrip strength and hypertension in older adults.

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Risk factors for delirium among older adults in the emergency department: a systematic review protocol

BMJ Open ◽

10.1136/bmjopen-2020-039175 ◽

2020 ◽

Vol 10 (7) ◽

pp. e039175

Author(s):

Lucas Oliveira J e Silva ◽

Michelle J Berning ◽

Jessica A Stanich ◽

Danielle J Gerberi ◽

Jin Han ◽

...

Keyword(s):

Risk Factors ◽

Systematic Review ◽

Older Adults ◽

Emergency Department ◽

Risk Factor ◽

Random Effect ◽

Quantitative Relationship ◽

Original Research ◽

Eligibility Criteria ◽

Screening Process

IntroductionDelirium is commonly missed in older adults presenting to the emergency department (ED). Although current recommendations for active screening of delirium in the ED, this might not be feasible or practical. Identifying patients at high risk for prevalent and incident delirium in the ED will help to improve the screening process and to build interventions. There is currently scattered synthesis of evidence on risk factors associated with delirium in the ED. To address this gap, we are conducting a systematic review to describe the risk factors (patient vulnerability factors and precipitating factors) for delirium in the ED.Methods and analysisA literature search was performed from inception to March 2020 in Ovid EBM Reviews, Ovid EMBASE, Ovid MEDLINE, Scopus and Web of Science. We will include original research studies that report a quantitative relationship between at least one risk factor and delirium in the ED setting. Two investigators will use eligibility criteria from this protocol to independently screen titles and abstracts, and select studies based on full-text review of potentially eligible studies. After arriving at a final set of included studies, two investigators will extract data using a standardised data collection form. If appropriate, data regarding each risk factor will be pooled through a random-effect meta-analysis. The Grading of Recommendations Assessment, Development and Evaluation approach will be used to evaluate the overall quality of evidence.Ethics and disseminationTo our knowledge, this will be the first systematic review evaluating risk factors for prevalent and incident delirium specifically related to the ED setting. Results of this study will aid in the identification of older adults at risk for delirium in the ED. We aim to publish the results of this systematic review in a peer-reviewed journal with good visibility for the fields of emergency medicine and geriatrics.PROSPERO registration numberCDR42020175261

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Transforming Clinical Trial Eligibility Criteria to Reflect Practical Clinical Application

American Society of Clinical Oncology Educational Book ◽

10.1200/edbk_155880 ◽

2016 ◽

pp. 83-90 ◽

Cited By ~ 4

Author(s):

Edward S. Kim ◽

Jennifer Atlas ◽

Gwynn Ison ◽

Jennifer L. Ersek

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Diagnostic Testing ◽

Standard Of Care ◽

Trial Participation ◽

Eligibility Criteria ◽

Number Of Patients ◽

Oncology Clinical Trials ◽

Clinical Trial Accrual ◽

Clinical Trial Results

Historically, oncology clinical trials have focused on comparing a new drug’s efficacy to the standard of care. However, as our understanding of molecular pathways in oncology has evolved, so has our ability to predict how patients will respond to a particular drug, and thus comparison with a standard therapy has become less important. Biomarkers and corresponding diagnostic testing are becoming more and more important to drug development but also limit the type of patient who may benefit from the therapy. Newer clinical trial designs have been developed to assess clinically meaningful endpoints in biomarker-enriched populations, and the number of modern, molecularly driven clinical trials are steadily increasing. At the same time, barriers to clinical trial enrollment have also grown. Many barriers contribute to nonenrollment in clinical trials, including patient, physician, institution, protocol, and regulatory barriers. At the protocol level, eligibility criteria have become a large roadblock to clinical trial accrual. Over time, eligibility criteria have become more and more restrictive. To accrue an adequate number of patients to molecularly driven trials, we should consider eligibility criteria carefully and attempt to reduce restrictive criteria. Reducing restrictive eligibility criteria will allow more patients to be eligible for clinical trial participation, will likely increase the speed of drug approvals, and will result in clinical trial results that more accurately reflect treatment of the population in the clinical setting.

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Sarcopenia is associated with hypertension in older adults: a systematic review and meta-analysis

10.21203/rs.2.20678/v2 ◽

2020 ◽

Author(s):

Tingting Bai ◽

Fang Fang ◽

Feika Li ◽

Yan Ren ◽

Jiaan Hu ◽

...

Keyword(s):

Systematic Review ◽

Older Adults ◽

Confidence Interval ◽

Old Age ◽

Handgrip Strength ◽

Meta Analysis ◽

Cochrane Library ◽

Original Research ◽

Inclusion Criteria ◽

Asian Group

Abstract Background: Sarcopenia and handgrip strength have been observed and correlated in association with hypertension among the old-age people. However, the results reported in different studies were inconsistent. In the current study, we conducted a systematic review and meta-analysis to reveal the significant association between sarcopenia, handgrip strength, and hypertension in older adults. Methods: PubMed, MEDLINE, Cochrane Library, and EMBASE databases were searched from inception to 15 November, 2019 to retrieve the original research studies that addressed the association between sarcopenia, handgrip strength, and hypertension. All the relevant data were retrieved, analyzed, and summarized. Results: 19 studies met the inclusion criteria and a total of 21301 participants were included in the meta-analysis. Eight eligible studies have reported the odd ratios (ORs) of hypertension and the ORs ranged from 0.41 to 4.38. When pooled the ORs together, the summarized ORs was 1.29 [95% confidence interval (CI) =1.00-1.67]. The summarized ORs for the Asian group 1.50 (95% CI=1.35-1.67) was significantly higher than that of Caucasian group 1.08 (95% CI=0.39-2.97). Eleven studies have provided the data on association between handgrip strength and hypertension. The overall ORs and 95% CI was 0.99 (95% CI=0.80-1.23), showing no significant association. Conclusion: Sarcopenia was associated with hypertension, but no correlation was found between handgrip strength and hypertension in older adults.

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Intervention Therapies to Reduce Pain-Related Fear in Fibromyalgia Syndrome: A Systematic Review of Randomized Clinical Trials

Pain Medicine ◽

10.1093/pm/pnaa331 ◽

2020 ◽

Author(s):

Javier Martinez-Calderon ◽

Mar Flores-Cortes ◽

Jose Miguel Morales-Asencio ◽

Alejandro Luque-Suarez

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Randomized Clinical Trials ◽

Risk Of Bias ◽

Cochrane Library ◽

Secondary Outcome ◽

Full Detail ◽

Eligibility Criteria ◽

Fear Avoidance Beliefs

Abstract Objective This systematic review aimed to evaluate the effectiveness of different interventions at reducing pain-related fear in people with fibromyalgia and to analyze whether the included trials reported their interventions in full detail. Design Systematic review. Setting No restrictions. Methods The Cochrane Library, CINAHL, EMBASE, PsycINFO, PubMed, and Scopus were searched from their inception to April 2020, along with manual searches and a gray literature search. Randomized clinical trials were included if they assessed pain-related fear constructs as the primary or secondary outcome in adults with fibromyalgia. Two reviewers independently performed the study selection, data extraction, risk-of-bias assessment, Template for Intervention Description and Replication (TIDieR) checklist assessment, and grading the quality of evidence. Results Twelve randomized clinical trials satisfied the eligibility criteria, including 11 cohorts with a total sample of 1,441 participants. Exercise, multicomponent, and psychological interventions were more effective than controls were in reducing kinesiophobia. However, there were no differences in decreasing kinesiophobia when self-management and electrotherapy were used. There were also no differences between groups with regard to the rest of the interventions and pain-related constructs (fear-avoidance beliefs, fear of pain, and pain-related anxiety). However, a serious risk of bias and a very serious risk of imprecision were detected across the included trials. This caused the overall certainty of the judged evidence to be low and very low. Additionally, the included trials reported insufficient details to allow the full replication of their interventions. Conclusions This systematic review shows that there are promising interventions, such as exercise, multicomponent, and psychological therapies, that may decrease one specific type of fear in people with fibromyalgia, i.e., kinesiophobia. However, because of the low–very low certainty of the evidence found, a call for action is needed to improve the quality of randomized clinical trials, which will lead to more definitive information about the clinical efficacy of interventions in this field.

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Re-Evaluating Eligibility Criteria for Oncology Clinical Trials: Analysis of Investigational New Drug Applications in 2015

Journal of Clinical Oncology ◽

10.1200/jco.2017.73.4186 ◽

2017 ◽

Vol 35 (33) ◽

pp. 3745-3752 ◽

Cited By ~ 42

Author(s):

Susan Jin ◽

Richard Pazdur ◽

Rajeshwari Sridhara

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Patient Population ◽

Trial Participation ◽

Cancer Clinical Trials ◽

Eligibility Criteria ◽

New Drug ◽

Drug Clinical Trial ◽

Oncology Clinical Trials ◽

Eligibility Requirements

Clinical trial eligibility criteria are necessary to define the patient population under study and improve trial safety. However, there are concerns that eligibility criteria for cancer clinical trials are too restrictive and limit patient enrollment in clinical trials. Recently, there have been initiatives to re-examine and modernize eligibility criteria for oncology clinical trials. To assess current eligibility requirements for cancer clinical trials, we have conducted a comprehensive review of eligibility criteria for commercial investigational new drug clinical trial applications submitted to the US Food and Drug Administration Office of Hematology and Oncology Products in 2015. Our findings suggest that eligibility criteria for current cancer clinical trials tend to narrowly define the study population and limit the study to lower-risk patients, which may not be reflective of the greater patient population outside of the study. We discuss potential areas for expanding eligibility criteria to include more patients in clinical trials and design options for clinical trials incorporating expanded eligibility criteria. The broadening of clinical trial eligibility criteria can be considered to better reflect the real-world patient population, improve clinical trial participation, and increase patient access to new investigational treatments.

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Regenerative endodontic treatment performed with platelet-rich plasma presents better periapical healing than only induced blot clot: a systematic review

Research Society and Development ◽

10.33448/rsd-v10i13.21219 ◽

2021 ◽

Vol 10 (13) ◽

pp. e147101321219

Author(s):

Christine Men Martins ◽

Milena Filippini Knecht ◽

Larissa dos Santos de Moraes ◽

Victor Eduardo de Souza Batista

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Primary Outcome ◽

Randomized Clinical Trials ◽

Platelet Rich Plasma ◽

Permanent Teeth ◽

Cochrane Library ◽

Eligibility Criteria ◽

Periapical Healing ◽

Regenerative Endodontic Treatment

This study comprehensively reviewed two different treatments for regenerative endodontic: platelet-rich plasma and induced blot clot, in regarding to periapical healing. Two investigators performed a systematic review. MEDLINE/PubMed, Cochrane Library and Scopus supplied relevant data from studies published until December 2020 to answer the PICO question. Primary outcome was periapical healing. Eight randomized clinical trials fulfilled eligibility criteria. Primary outcome indicated that platelet-rich plasma results in similar or better periapical healing compared to blot clot group. The reported failures were related to blot clot group due to incomplete radiographic parameters, pain and reinfection; however, few cases of unsuccess were reported to platelet-rich plasma group. Only two studies observed better results to blot clot group in relation to increase of radiographic area and partial pulp canal obliteration. This review showed that procedures using platelet-rich plasma were successful in treating permanent teeth with root development.

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Probiotic Strains and Intervention Total Doses for Modulating Obesity-Related Microbiota Dysbiosis: A Systematic Review and Meta-analysis

Nutrients ◽

10.3390/nu12071921 ◽

2020 ◽

Vol 12 (7) ◽

pp. 1921 ◽

Cited By ~ 1

Author(s):

Ana López-Moreno ◽

Antonio Suárez ◽

Camila Avanzi ◽

Mercedes Monteoliva-Sánchez ◽

Margarita Aguilera

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Full Text ◽

Clinical Studies ◽

Meta Analysis ◽

Plasma Lipid ◽

Gut Hormones ◽

Positive Association ◽

Cochrane Library ◽

Probiotic Strains

Obesity is a growing health threat worldwide. Administration of probiotics in obesity has also parallelly increased but without any protocolization. We conducted a systematic review exploring the administration pattern of probiotic strains and effective doses for obesity-related disorders according to their capacity of positively modulating key biomarkers and microbiota dysbiosis. Manuscripts targeting probiotic strains and doses administered for obesity-related disorders in clinical studies were sought. MEDLINE, Scopus, Web of Science, and Cochrane Library databases were searched using keywords during the last fifteen years up to April 2020. Two independent reviewers screened titles, abstracts, and then full-text papers against inclusion criteria according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. From 549 interventional reports identified, we filtered 171 eligible studies, from which 24 full-text assays were used for calculating intervention total doses (ITD) of specific species and strains administered. Nine of these reports were excluded in the second-step because no specific data on gut microbiota modulation was found. Six clinical trials (CT) and 9 animal clinical studies were retained for analysis of complete outcome prioritized (body mass index (BMI), adiposity parameters, glucose, and plasma lipid biomarkers, and gut hormones). Lactobacillus spp. administered were double compared to Bifidobacterium spp.; Lactobacillus as single or multispecies formulations whereas most Bifidobacteria only through multispecies supplementations. Differential factors were estimated from obese populations’ vs. obesity-induced animals: ITD ratio of 2 × 106 CFU and patterns of administrations of 11.3 weeks to 5.5 weeks, respectively. Estimation of overall probiotics impact from selected CT was performed through a random-effects model to pool effect sizes. Comparisons showed a positive association between the probiotics group vs. placebo on the reduction of BMI, total cholesterol, leptin, and adiponectin. Moreover, negative estimation appeared for glucose (FPG) and CRP. While clinical trials including data for positive modulatory microbiota capacities suggested that high doses of common single and multispecies of Lactobacillus and Bifidobacterium ameliorated key obesity-related parameters, the major limitation was the high variability between studies and lack of standardized protocols. Efforts in solving this problem and searching for next-generation probiotics for obesity-related diseases would highly improve the rational use of probiotics.

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