Older adult participation in cancer clinical trials: A systematic review of barriers and interventions.
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ABSTRACT:
SUBMITTER: Sedrak MS
PROVIDER: S-EPMC7854940 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Importance:Randomized clinical trials (RCTs) of lipid-lowering therapies form the evidence base for national and international guidelines. However, concerns exist that women and older patients are underrepresented in RCTs. Objective:To determine the trends of representation of women and older patients (?65 years) in RCTs of lipid-lowering therapies from 1990 to 2018. Data Sources:The electronic databases of MEDLINE and ClinicalTrials.gov were searched from January 1990 through December 2018. Study Selection:RCTs of lipid-lowering therapies with sample sizes of at least 1000 patients and follow-up periods of at least 1 year were included. Data Extraction and Synthesis:Two independent investigators abstracted the data on a standard data collection form. Main Outcomes and Measures:Patterns of representation of women and older adults were examined overall in lipid-lowering RCTs and according to RCT-level specific characteristics. The participation-to-prevalence ratio (PPR) metric was used to estimate the representation of women compared with their share of disease burden. Results:A total of 60 RCTs with 485?409 participants were included. The median (interquartile range) number of participants per trial was 5264 (1062-27?564). Overall, representation of women was 28.5% (95% CI, 24.4%-32.4%). There was an increase in the enrollment of women from the period 1990 to 1994 (19.5%; 95% CI, 18.4%-20.5%) to the period 2015 to 2018 (33.6%; 95% CI, 33.4%-33.8%) (P for trend?=?.01). Among common limiting factors were inclusion of only postmenopausal women or surgically sterile women (28.3%; 95% CI, 18.5%-40.7%) or exclusion of pregnant (23.3%; 95% CI, 14.4%-35.4%) and lactating (16.6%; 95% CI, 9.3%-28.1%) women. Women were underrepresented compared with their disease burden in lipid RCTs of diabetes (PPR, 0.74), heart failure (PPR, 0.27), stable coronary heart disease (PPR, 0.48), and acute coronary syndrome (PPR, 0.51). Only 23 RCTs with 263?628 participants reported the proportion of older participants. Overall representation of older participants was 46.7% (95% CI, 46.5%-46.9%), which numerically increased from 31.6% (95% CI, 30.8%-32.3%) in the period 1995 to 1998 to 46.2% (95% CI, 46.0%-46.5%) in the period 2015 to 2018 (P for trend?=?.43). A total of 53.0% (95% CI, 41.8%-65.3%) and 36.6% (95% CI, 25.6% to 49.3%) trials reported outcomes according to sex and older participants, respectively, which did not improve over time. Conclusions and Relevance:In this systematic review of RCTs of lipid-lowering therapies, the enrollment of women and older participants increased over time, but women and older participants remained consistently underrepresented. This limits the evidence base for efficacy and safety in these subgroups.
| S-EPMC7243092 | biostudies-literature
Project description:BackgroundClinical trials for identification of efficient and effective new diagnostic and treatment modalities are needed to address disproportionately high burden of communicable (e.g., HIV/AIDS, tuberculosis, and malaria) and non-communicable diseases (e.g., diabetes) in developing countries. However, gross under-representation in global clinical trial platforms contributes to sustained health inequity in these countries. We reviewed the literature on barriers facing clinical researchers in developing countries for conducting clinical trials in their countries.MethodsLiterature indexed in PubMed, Embase, CINAHL and Web of Science, WHO Global Health Library were searched. Grey literature was also searched. Search key words included barriers, challenges, clinical trials and developing countries. Articles within the scope of this review were appraised by two reviewers.ResultsTen studies, which are reported in 15 papers, were included in this review. Following critical review we identified five unifying themes for barriers. Barriers for conducting clinical trials included lack of financial and human capacity, ethical and regulatory system obstacles, lack of research environment, operational barriers and competing demands.Conclusion and recommendationThere were substantial barriers at system, organization and individual level. We propose that to address this problem, instituting a system for wider implementation of local investigator-initiated trials is warranted. These trials are more applicable to local populations because they build on local healthcare knowledge. They are more demand-led, influence policy and responsive to a country's needs because they are driven by a local or national agenda.
| S-EPMC5863824 | biostudies-literature
Project description:ObjectiveTo assess the relative effectiveness of interventions to prevent falls in older adults to either a usual care group or control group.DesignSystematic review and meta-analyses.Data sourcesMedline, HealthSTAR, Embase, the Cochrane Library, other health related databases, and the reference lists from review articles and systematic reviews.Data extractionComponents of falls intervention: multifactorial falls risk assessment with management programme, exercise, environmental modifications, or education.Results40 trials were identified. A random effects analysis combining trials with risk ratio data showed a reduction in the risk of falling (risk ratio 0.88, 95% confidence interval 0.82 to 0.95), whereas combining trials with incidence rate data showed a reduction in the monthly rate of falling (incidence rate ratio 0.80, 0.72 to 0.88). The effect of individual components was assessed by meta-regression. A multifactorial falls risk assessment and management programme was the most effective component on risk of falling (0.82, 0.72 to 0.94, number needed to treat 11) and monthly fall rate (0.63, 0.49 to 0.83; 11.8 fewer falls in treatment group per 100 patients per month). Exercise interventions also had a beneficial effect on the risk of falling (0.86, 0.75 to 0.99, number needed to treat 16) and monthly fall rate (0.86, 0.73 to 1.01; 2.7).ConclusionsInterventions to prevent falls in older adults are effective in reducing both the risk of falling and the monthly rate of falling. The most effective intervention was a multifactorial falls risk assessment and management programme. Exercise programmes were also effective in reducing the risk of falling.
| S-EPMC381224 | biostudies-literature
Project description:BackgroundBarriers to cancer clinical trial participation have been the subject of frequent study, but the rate of trial participation has not changed substantially over time. Studies often emphasize patient-related barriers, but other types of barriers may have greater impact on trial participation. Our goal was to examine the magnitude of different domains of trial barriers by synthesizing prior research.MethodsWe conducted a systematic review and meta-analysis of studies that examined the trial decision-making pathway using a uniform framework to characterize and quantify structural (trial availability), clinical (eligibility), and patient/physician barrier domains. The systematic review utilized the PubMed, Google Scholar, Web of Science, and Ovid Medline search engines. We used random effects to estimate rates of different domains across studies, adjusting for academic vs community care settings.ResultsWe identified 13 studies (nine in academic and four in community settings) with 8883 patients. A trial was unavailable for patients at their institution 55.6% of the time (95% confidence interval [CI] = 43.7% to 67.3%). Further, 21.5% (95% CI = 10.9% to 34.6%) of patients were ineligible for an available trial, 14.8% (95% CI = 9.0% to 21.7%) did not enroll, and 8.1% (95% CI = 6.3% to 10.0%) enrolled. Rates of trial enrollment in academic (15.9% [95% CI = 13.8% to 18.2%]) vs community (7.0% [95% CI = 5.1% to 9.1%]) settings differed, but not rates of trial unavailability, ineligibility, or non-enrollment.ConclusionsThese findings emphasize the enormous need to address structural and clinical barriers to trial participation, which combined make trial participation unachievable for more than three of four cancer patients.
| S-EPMC6410951 | biostudies-literature
Project description:BackgroundCachexia is a multisystem syndrome characterized by weight loss, anorexia, loss of muscle mass, systemic inflammation, insulin resistance, and functional decline. Management of cachexia involves addressing multiple underlying biological mechanisms. Previous review on pharmacological management of cancer cachexia identified progestins and corticosteroids as effective agents for treatment of cachexia. However, to date no consensus exists on a single effective or standard treatment for management of cachexia. The aim of this systematic review is to determine the effectiveness of pharmacological treatments used to manage cachexia among adult cancer patients.MethodsWe performed literature searches of PubMed (NLM), Embase (Ovid), and Medline(Ovid) to identify clinical trials focused on pharmacological management of cancer cachexia among adult cancer patients from 2004 to 2018. Three reviewers screened a random selection of abstracts to measure for interrater reliability. After this step, each screener screened two-thirds of all abstracts and 177 studies were identified for full text review. The primary outcome was impact of pharmacological management on change in either weight or lean body mass in cancer patients.ResultsWe identified 19 articles (representing 20 RCTs) that focused on pharmacological management of cancer cachexia. Agents showing promising results included Anamorelin and Enobosarm. Anamorelin at 50 or 100?mg per day for 12?weeks showed a consistent benefit across all studies and resulted in significant improvement in weight as compared to baseline among cancer patients. Enobosarm at 1 and 3?mg per day was also effective in improving lean body mass and QOL symptoms among advancer stage cancer patients. Finally, use of combination agents provide evidence for targeting multiple pathways underlying cachexia mechanism to achieve maximum benefit. No agents showed functional improvement in cancer patients.ConclusionAnamorelin as a single agent shows promising results in improving cachexia related weight loss among cancer patients. Further research on combination therapies may be helpful to address critical gaps in cachexia management.
| S-EPMC6260745 | biostudies-literature
Project description:Numerous studies have detailed the physical health benefits of children's participation in sport and a growing body of research also highlights the benefits for mental health. Children who participate in sport have also been shown to be advantaged academically. However, despite the benefits there is evidence that children are leading increasingly sedentary lifestyles and are at greater risk of chronic disease than those with active lifestyles. Sport provides an important means for children to achieve their recommended amount of daily physical activity. This systematic review asks 'what are those barriers to children's participation in sport?'Literature searches were carried out in June 2015 using; EMBASE, Medline, CINAHL and SportDiscus using the search terms barrier*, stop*, prevent*, participat*, taking part, Sports/, sport*, "physical education", PE, child*, young person*, adolescen*. These were supplemented with hand searches. A total of 3434 records were identified of which 22 were suitable for inclusion in the review, two additional studies were identified from Google Scholar in November 2016. Both qualitative and quantitative studies were included. Study's included in the review assessed children up to 18 years of age. Study quality was assessed using Critical Appraisal Skills Programme (CASP) tools.Studies took place in the school environment (n = 14), sports club (n = 1), community setting (n = 8) and adolescent care setting (n = 1). Frequently reported barriers across quantitative studies were 'time' (n = 4), 'cost' (n = 3), 'opportunity/accessibility' (n = 3) and 'friends' (n = 2). Frequently reported barriers across qualitative studies were 'time' (n = 6), 'cost' (n = 5), 'not being good at sport' (n = 6) and 'fear of being judged/embarrassed' (n = 6).Policy makers, parents and teachers should all be aware that 'cost' and 'time' are key barriers to participation in sport. More local sports opportunities are needed where costs are reduced. Schools and local clubs could better work together to provide more affordable local opportunities to increase children's participation in sport.
| S-EPMC5810190 | biostudies-other
Project description:BackgroundRacial and ethnic minorities (REMs) continue to be underrepresented in clinical trials despite the 1993 National Institutes of Health's Revitalization Act mandating the representation of women and underrepresented minority groups in clinical trials. Although Blacks represent 15% and Hispanics 13% of the cancer population, their clinical trial enrollment rates are disproportionately low at 4% to 6% and 3% to 6%, respectively. A systematic review exploring interventions aimed at improving cancer clinical trial (CCT) enrollment for REMs was conducted.MethodsA systematic search of PubMed, Cochrane CENTRAL, and Ovid PsycINFO was conducted for English-language studies since 1993. Inclusion criteria included peer-reviewed, US-based studies with interventions aimed to recruit underrepresented minority adult patients into cancer clinical trials. REM groups were defined as Black, Hispanic, Asian, American Indian, and Native Hawaiian/other Pacific Islander.ResultsThe systematic search identified 3123 studies, of which nine met inclusion criteria. 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). A statistically significant improvement in accrual was shown in three of the patient navigation interventions, one of the clinical trial educational videos and an institutional research infrastructure change.ConclusionsThis systematic review illustrates several potential mechanisms by which to increase CCT recruitment for patients of REM backgrounds in various clinical settings. More randomized controlled trials are needed to further explore the benefits of these interventions for REMs.
| S-EPMC10456972 | biostudies-literature
Project description:BackgroundTo investigate the efficacy and safety of interventions for early stage pericoronitis.MethodsWe searched for randomized controlled trials (RCTs) in databases from inception to July 2020, without language restriction. RCTs assessing adolescents and adults were included.ResultsSeven RCT with clinical diversity were included, so, it was not possible to conduct meta-analyses. Individual study data showed an improvement in oral health quality of life in favor of topical benzydamine versus diclofenac capsule (Mean difference (MD) -1.10, 95% Confidence interval (CI) -1.85 to -0.35), and no difference between topical benzydamine and flurbiprofen capsule (MD -0.55 95% CI -1.18 to 0.0). There was no difference between diclofenac and flurbiprofen capsules (MD 0.55, 95% CI -0.29 to 1.39). An imprecise estimate of effects was found for all outcomes, considering (i) oral versus topic pharmacological treatment, (ii) different oral pharmacological treatments, (iii) pharmacological treatment associated with laser versus placebo laser, (iv) pharmacological treatment associated with different mouthwashes, and (v) conventional treatment associated to antimicrobial photodynamic therapy versus conventional treatment, with low to very low certainty of evidence.ConclusionsUntil future well-designed studies can be conducted, the clinical decision for early stage pericoronitis should be guided by individual characteristics, settings and financial aspects.
| S-EPMC8772688 | biostudies-literature
Project description:BackgroundThere are many barriers to patient participation in randomised controlled trials of cancer treatments. To increase participation in trials, strategies need to be identified to overcome these barriers. Our aim was to assess the effectiveness of interventions to overcome barriers to patient participation in randomised controlled trials (RCTs) of cancer treatments.MethodsA systematic review was conducted. Published and unpublished studies in any language were searched for in fifteen electronic databases, including MEDLINE, EMBASE, CINAHL and PsycINFO, from inception to the end of 2004. Studies of any interventions to improve cancer patient participation in RCTs, which reported the change in recruitment rates, were eligible for inclusion. RCTs and non-randomised controlled trials as well as before and after studies reporting baseline rates specific to the population being investigated were included. Data were extracted by one reviewer into structured summary tables and checked for accuracy by a second reviewer. Each included study was assessed against a checklist for methodological quality by one reviewer and checked by a second reviewer. A narrative synthesis was conducted.ResultsEight studies were identified that met the inclusion criteria: three RCTs, two non-randomised controlled trials and three observational studies. Six of the studies had an intervention that had some relevance to the UK. There was no robust evidence that any of the interventions investigated led to an increase in cancer patient participation in RCTs, though one good quality RCT found that urologists and nurses were equally effective at recruiting participants to a treatment trial for prostate cancer. Although there was no evidence of an effect in any of the studies, the evidence was not of sufficient quality to be able to conclude that these interventions therefore do not work.ConclusionThere is not a strong evidence-base for interventions that increase cancer patient participation in randomised trials. Further research is required to evaluate the effectiveness of strategies to increase participation in cancer treatment trials.
| S-EPMC1489947 | biostudies-literature
Project description:BackgroundIn recent years, there has been a global trend toward an increase in life expectancy and the proportion of elderly people among the population. In this regard, it becomes important to promote active and healthy aging. Physical inactivity and social isolation are both risk factors of many chronic illnesses and highly prevalent in older adults. This challenges communities to develop interventions that reduce these risk factors among elderly populations. The main aims of this study were to summarize community-based interventions that aim to simultaneously promote social participation and physical activity in older adults and to examine their effects.MethodsWe performed a systematic review based on the PRISMA standards. Literature searches were conducted in six scientific databases in July 2021. Articles were included if they had an interventional design, focused on older adults living in the community and measured social participation and physical activity as an outcome. The data were summarized narratively due to the heterogeneity of studies and the variety of outcome measures.ResultsOverall, 46 articles published in English were included. The studies were grouped in (1) interventions with main focus on physical activity promotion; (2) social activities that included a physical activity component; (3) health behavior interventions/ health education interventions; (4) multicomponent interventions; (5) environmental interventions. The majority of the reviewed studies reported positive effects of interventions on physical activity and/or social participation. No study reported negative effects. Analysis of quantitative studies showed that multicomponent interventions have great positive effects on both outcomes. In qualitative studies positive effects were found regardless of intervention type.ConclusionThis review summarizes the evidence about the effects of community-based interventions that aim to promote social participation and physical activity in older adults. Multicomponent interventions seem to be most suitable for simultaneous promotion of physical activity and social participation. However, high variability in measurement methods used to assess both social participation and physical activity in the included studies made it difficult to compare studies and to indicate the most effective.Systematic review registrationwww.crd.york.ac.uk, identifier: PROSPERO [CRD42021268270].
| S-EPMC9768837 | biostudies-literature