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The Lancet. Oncology Feb 2006Enrolling participants onto clinical trials of cancer presents an important challenge. We aimed to identify the concerns of patients with cancer about, and the barriers... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Enrolling participants onto clinical trials of cancer presents an important challenge. We aimed to identify the concerns of patients with cancer about, and the barriers to, participation in clinical trials.
METHODS
We did a systematic review to assess studies of barriers to participation in experimental trials and randomised trials for validity and content. We estimated the frequency with which patients identified particular issues by pooling across studies that presented data for barriers to participation in clinical trials as proportions.
FINDINGS
We analysed 12 qualitative studies (n=722) and 21 quantitative studies (n=5452). Two qualitative studies inquired of patients who were currently enrolled onto clinical trials, and ten inquired of patients who were eligible for enrolment onto various clinical trials. Barriers to participation in clinical trials were protocol-related, patient-related, or physician-related. The most common reasons cited as barriers included: concerns with the trial setting; a dislike of randomisation; general discomfort with the research process; complexity and stringency of the protocol; presence of a placebo or no-treatment group; potential side-effects; being unaware of trial opportunities; the idea that clinical trials are not appropriate for serious diseases; fear that trial involvement would have a negative effect on the relationship with their physician; and their physician's attitudes towards the trial. Meta-analysis confirmed the findings of our systematic review.
INTERPRETATION
The identification of such barriers to the participation in clinical trials should help trialists to develop strategies that will keep to a maximum participation and cooperation in cancer trials, while informing and protecting prospective participants adequately.
Topics: Clinical Trials as Topic; Humans; Neoplasms; Refusal to Participate
PubMed: 16455478
DOI: 10.1016/S1470-2045(06)70576-9 -
Disability and Health Journal Jan 2022Sports participation has many physical and mental health benefits for individuals with a disability including improved functionality and reduced anxiety, yet a large... (Review)
Review
BACKGROUND
Sports participation has many physical and mental health benefits for individuals with a disability including improved functionality and reduced anxiety, yet a large proportion of individuals with a disability are inactive.
OBJECTIVE
To investigate the experiences and perceived health benefits of sport participation across four disability populations: children and adolescents, adults, elite athletes and veterans with a disability.
METHODS
A mixed-methods systematic review was conducted. Eligible studies had participants who were children, adults, elite athletes or veterans with a physical, visual or intellectual disability. Data were extracted using the Joanna Briggs Institute (JBI) tool and quality assessment involved the Quality Assessment Tool for Studies with Diverse Designs (QATSDD). Content, thematic and narrative synthesis techniques were used. Confidence in cumulative evidence was determined using GRADE-CERQual and Classes of Evidence.
RESULTS
Several positive aspects of sport participation were highlighted across all four populations, including socialisation opportunities, pure enjoyment, a sense of freedom and providing an arena to challenge stereotypes. The paucity of research within the 'veterans with a disability' group limited analysis of experiences and benefits of sport in this population.
CONCLUSIONS
This systematic review was the first to explore this phenomena, finding that overall sport is a beneficial experience for individuals with a disability. The positive aspects should be promoted when encouraging sport participation for children, adolescents, adults and elite athletes. More research is needed to explore these phenomena in veterans and to compare perceived benefits between populations to enable tailored promotion of sport.
Topics: Adolescent; Adult; Athletes; Child; Disabled Persons; Health Status; Humans; Mental Health; Sports
PubMed: 34238729
DOI: 10.1016/j.dhjo.2021.101164 -
JRSM Open Jun 2023Patient-centred trial design and delivery; improves recruitment and retention; increases participant satisfaction; encourages participation by a more representative...
Patient-centred trial design and delivery; improves recruitment and retention; increases participant satisfaction; encourages participation by a more representative cohort; and allows researchers to better meet participants' needs. Research in this area mostly focusses on narrow facets of trial participation. We aimed to systematically identify the breadth of patient-centred factors influencing participation and engagement in trials, and collate them into a framework. Through this we hoped to assist researchers to identify factors that could improve patient-centred trial design and delivery. Robust qualitative and mixed methods systematic reviews are becoming increasingly common in health research. The protocol for this review was prospectively registered on PROSPERO, CRD42020184886. We used the SPIDER (Sample, Phenomenon of Interest, Design, Evaluation, Research Type) framework as a standardised systematic search strategy tool. 3 databases were searched as well as references checking, and thematic synthesis was conducted. Screening agreement was performed and code and theme checking were conducted by 2 independent researchers. Data were drawn from 285 peer-reviewed articles. 300 discrete factors were identified, and sorted into 13 themes and subthemes. The full catalogue of factors is included in the Supplementary Material. A summary framework is included in the body of the article. This paper focusses on outlining common ground that themes share, highlighting critical features, and exploring interesting points from the data. Through this, we hope researchers from multiple specialities may be better able to meet patients' needs, protect patients' psychosocial wellbeing, and optimise trial recruitment and retention, with direct positive impact on research time and cost efficiency.
PubMed: 37325779
DOI: 10.1177/20542704231166621 -
Diabetes & Metabolic Syndrome Jul 2022Our aim in this meta-analysis was to determine the effect of soy and soy product supplementation on serum adiponectin levels. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND AND AIMS
Our aim in this meta-analysis was to determine the effect of soy and soy product supplementation on serum adiponectin levels.
METHOD
A systematic search was conducted using Medline (PubMed and Web of Science), Scopus, and Cochrane Library for eligible trials up to August 2020. A random-effects model was used to pool calculated effect sizes.
RESULTS
Seven trials were included in the overall analysis. Our analysis showed that soy and soy product supplementation did not significantly affect adiponectin concentrations (WMD = -0.77 μg/ml, 95% CI: -0.61, 2.15, P = 0.27) in comparison with a placebo. The between-study heterogeneity was high (I: 68.2%, P = 0.004). Subgroup analysis, based on participants' health status and duration of the supplementation, could not detect the potential source of the observed heterogeneity. In addition, subgroup analysis showed that the effect was not statistically significant in all subgroups.
CONCLUSION
Overall, soy and soy product supplementation did not change the circulatory adiponectin levels. In addition, the results were not affected by the participant's health status and duration of supplementation. However, further studies are needed to confirm the present results.
Topics: Adiponectin; Dietary Supplements; Humans; Nutrients; Randomized Controlled Trials as Topic; Glycine max
PubMed: 35803164
DOI: 10.1016/j.dsx.2022.102558 -
Prevention Science : the Official... May 2022Strength training (ST) or resistance training is important in the development and maintenance of musculoskeletal and cardiovascular health in women of all ages; however,... (Review)
Review
Strength training (ST) or resistance training is important in the development and maintenance of musculoskeletal and cardiovascular health in women of all ages; however, uptake of ST amongst women is low. To improve female musculoskeletal health, it is vital that more women are encouraged to participate in ST to maintain musculoskeletal integrity. This systematic review aimed to identify motivators and barriers to women initiating and maintaining ST. Following protocol registration and systematic search, studies were included if they were primary qualitative or mixed-method studies reporting participant verbatim quotes, included adult women, and focused on motivators and barriers for ST. Searches generated 2534 articles from 3 databases, with 20 studies (N = 402 participants) meeting eligibility criteria. Participant quotes and authors' interpretations were analysed using thematic synthesis. The most frequently observed barriers were gender-based stigmas, discouragement, and negative comments, particularly in women currently engaging in ST. Other factors associated with poor adherence included boredom, poor knowledge of ST, poor gym accessibility, lack of supervision or routine, and difficulty in balancing work and family life. Social support from friends and family, words of affirmation, and accompaniment facilitated ST, particularly in older women. Women who saw expected results such as weight loss were motivated to continue ST. Interventions aimed at increasing participation in ST amongst women should focus on the specific benefits valued by women and the dissemination of accurate information to counter misconceptions and increase knowledge. The adaptation of gym environments to make them more welcoming to women, and reduce gender-focused criticism, is especially important.
Topics: Adult; Aged; Female; Humans; Motivation; Resistance Training; Social Support
PubMed: 34800250
DOI: 10.1007/s11121-021-01328-2 -
Alzheimer's & Dementia (New York, N. Y.) 2019Alzheimer's disease and related dementias (ADRD) disproportionately impact racial and ethnic minority and socioeconomically disadvantaged adults. Yet, these populations... (Review)
Review
INTRODUCTION
Alzheimer's disease and related dementias (ADRD) disproportionately impact racial and ethnic minority and socioeconomically disadvantaged adults. Yet, these populations are significantly underrepresented in research.
METHODS
We systematically reviewed the literature for published reports describing recruitment and retention of individuals from underrepresented backgrounds in ADRD research or underrepresented participants' perspectives regarding ADRD research participation. Relevant evidence was synthesized and evaluated for quality.
RESULTS
We identified 22 eligible studies. Seven studies focused on recruitment/retention approaches, all of which included multifaceted efforts and at least one community outreach component. There was considerable heterogeneity in approaches used, specific activities and strategies, outcome measurement, and conclusions regarding effectiveness. Despite limited use of prospective evaluation strategies, most authors reported improvements in diverse representation in ADRD cohorts. Studies evaluating participant views focused largely on predetermined explanations of participation including attitudes, barriers/facilitators, education, trust, and religiosity. Across all studies, the strength of evidence was low.
DISCUSSION
Overall, the quantity and quality of available evidence to inform best practices in recruitment, retention, and inclusion of underrepresented populations in ADRD research are low. Further efforts to systematically evaluate the success of existing and emergent approaches will require improved methodological standards and uniform measures for evaluating recruitment, participation, and inclusivity.
PubMed: 31921966
DOI: 10.1016/j.trci.2019.09.018 -
BMJ Open May 2023This systematic review aims to derive practical lessons from publications on patient involvement and engagement in the organisation of organ transplantation services.
OBJECTIVES
This systematic review aims to derive practical lessons from publications on patient involvement and engagement in the organisation of organ transplantation services.
DESIGN
This systematic review was conducted according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses. Inclusion criteria for the analysis of publications in English cited in the databases PubMed and Web of Science until 6 December 2022 required that patients participated as advisers in the organisation of organ transplantation services. Quality assessment was performed using the Guidance for Reporting Involvement of Patients and the Public (GRIPP) 2 small form and the Critical Appraisal Skills Programme (CASP) tool for the assessment of the risks of bias.
RESULTS
Deployed search strings identified 2263 records resulting in a total of 11 articles. The aims and strategies, deployed methods, observed effects, observed barriers and proposed improvements for the future varied vastly. All reported that well-developed programmes involving and engaging patients at an organisational level provide additional benefits for patients and foster patient-centred care. Lessons learnt include: (1) to empower patients, the information provided to them should be individualised to prioritise their needs; (2) financial as well as organisational resources are important to successfully implement patient involvement and engagement; (3) systematic feedback from patients in organisational structures to health providers is required to improve clinical workflows and (4) the consideration of ethical issues and the relationship between investigators and participating patients should be clarified and reported.
CONCLUSIONS
Actionable management recommendations could be derived. The quantitative impact on clinical outcome and economic clinical process improvements remains to be investigated. Study quality can be improved using the GRIPP 2 guidance and the CASP tool.
PROSPERO REGISTRATION NUMBER
CRD42022186467.
Topics: Humans; Patient Participation; Patients; Patient-Centered Care; Organ Transplantation
PubMed: 37164468
DOI: 10.1136/bmjopen-2023-072091 -
Journal of Medical Internet Research Sep 2023Providing informed consent means agreeing to participate in a clinical trial and having understood what is involved. Flawed informed consent processes, including missing... (Review)
Review
BACKGROUND
Providing informed consent means agreeing to participate in a clinical trial and having understood what is involved. Flawed informed consent processes, including missing dates and signatures, are common regulatory audit findings. Electronic consent (eConsent) uses digital technologies to enable the consenting process. It aims to improve participant comprehension and engagement with study information and to address data quality concerns.
OBJECTIVE
This systematic literature review aimed to assess the effectiveness of eConsent in terms of patient comprehension, acceptability, usability, and study enrollment and retention rates, as well as the effects of eConsent on the time patients took to perform the consenting process ("cycle time") and on-site workload in comparison with traditional paper-based consenting.
METHODS
The systematic review was conducted and reported in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Ovid Embase and Ovid MEDLINE were systematically searched for publications reporting original, comparative data on the effectiveness of eConsent in terms of patient comprehension, acceptability, usability, enrollment and retention rates, cycle time, and site workload. The methodological validity of the studies that compared outcomes for comprehension, acceptability, and usability across paper consent and eConsent was assessed. Study methodologies were categorized as having "high" validity if comprehensive assessments were performed using established instruments.
RESULTS
Overall, 37 publications describing 35 studies (13,281 participants) were included. All studies comparing eConsenting and paper-based consenting for comprehension (20/35, 57% of the studies; 10 with "high" validity), acceptability (8/35, 23% of the studies; 1 with "high" validity), and usability (5/35, 14% of the studies; 1 with "high" validity) reported significantly better results with eConsent, better results but without significance testing, or no significant differences in overall results. None of the studies reported better results with paper than with eConsent. Among the "high" validity studies, 6 studies on comprehension reported significantly better understanding of at least some concepts, the study on acceptability reported statistically significant higher satisfaction scores, and the study on usability reported statistically significant higher usability scores with eConsent than with paper (P<.05 for all). Cycle times were increased with eConsent, potentially reflecting greater patient engagement with the content. Data on enrollment and retention were limited. Comparative data from site staff and other study researchers indicated the potential for reduced workload and lower administrative burden with eConsent.
CONCLUSIONS
This systematic review showed that compared with patients using paper-based consenting, patients using eConsent had a better understanding of the clinical trial information, showed greater engagement with content, and rated the consenting process as more acceptable and usable. eConsent solutions thus have the potential to enhance understanding, acceptability, and usability of the consenting process while inherently being able to address data quality concerns, including those related to flawed consenting processes.
Topics: Humans; Data Accuracy; Digital Technology; Electronics; Informed Consent; Patient Participation
PubMed: 37656499
DOI: 10.2196/43883 -
Quality of Life Research : An... Apr 2012The aim of this systematic review was to document evidence of the association between leisure participation and quality of life (QoL) in children with neurodevelopmental... (Review)
Review
PURPOSE
The aim of this systematic review was to document evidence of the association between leisure participation and quality of life (QoL) in children with neurodevelopmental disabilities, and to identify the main factors that further clarify this relationship.
METHODS
An electronic search of the literature was conducted using Medline, Embase, PsycInfo, CINAHL, ERIC, OT Seeker, and the Cochrane library using relevant MESH heading and key words. An inductive thematic analysis was used to synthesize main findings from the studies. The mixed methods appraisal tool (MMAT) was used to assess the methodological quality of the included studies.
RESULTS
Nineteen studies were included in this systematic review. All 19 studies fulfilled most of the criteria outlined by the MMAT for each study design (quantitative, qualitative, and mixed methods). Mixed methods studies had the lowest MMAT scores. Seven themes were identified that further elucidate the important relationships between leisure participation and QoL: active physical leisure participation and physical well-being; leisure participation and self; leisure participation and emotional well-being; leisure participation and social well-being; leisure participation and cognition; leisure preferences and well-being; and negative aspects of leisure participation.
CONCLUSIONS
The use of thematic analysis enabled the synthesis of findings from quantitative, qualitative, and mixed methods study designs. Participating in both naturally occurring, spontaneous forms of leisure activities and participating in more structured types of leisure and therapeutic programs that focus on leisure contribute to improving the QoL of children with neurodevelopmental disabilities. A key aspect to consider is the child's ability to participate in his/her preferred leisure activities. Environmental adaptations may be required to ensure that the leisure opportunities meet the children's capabilities and contribute positively to their QoL.
Topics: Child; Disabled Children; Female; Humans; Leisure Activities; Male; Quality of Life; Research Design
PubMed: 22101860
DOI: 10.1007/s11136-011-0063-9 -
JBI Evidence Synthesis Jul 2022The objective of the review was to describe the incidence and prevalence of injuries among female cricket players of all ages, participating in all levels of play. (Meta-Analysis)
Meta-Analysis
OBJECTIVE
The objective of the review was to describe the incidence and prevalence of injuries among female cricket players of all ages, participating in all levels of play.
INTRODUCTION
Cricket, a bat-and-ball sport, is becoming popular among women of all ages and abilities worldwide. However, cricket participation carries a risk of injury. Injuries negatively affect sport participation, performance, and short- and long-term health and well-being. Injury prevention, therefore, is the key to safe, long-term cricket participation as a physical activity goal. Epidemiological data are needed to underpin evidence-based injury-prevention strategies.
INCLUSION CRITERIA
Studies reporting incidence and prevalence of injuries in female cricket players of all ages, participating in all levels of play, were included in this review, including studies that report data by sex or by sport. Studies were excluded if they did not have enough data to calculate prevalence or incidence, did not distinguish female injury data from male injury data, focused on athletes participating in other sports, or focused on case studies.
METHODS
A systematic review and meta-analyses were conducted according to the JBI and PRISMA 2020 guidelines. MEDLINE, SPORTDiscus, Physiotherapy Evidence Database (PEDro), EBSCO MasterFILE Premier, EBSCO CINAHL Complete, ProQuest Health and Medical Complete, Scopus, and ScienceDirect were systematically searched from inception to August 2021. Additionally, Cochrane Central Register of Controlled Trials and ClinicalTrials.gov were searched. EBSCO MegaFile Premier, OpenGrey (SIGLE), WorldCat, Grey Matters, Grey Literature, and Google Scholar were searched for gray literature. Full-text articles that met the inclusion criteria were critically appraised using tools from JBI, and were extracted and synthesized in narrative summary and tabular format. Three meta-analyses were conducted: injury incidence rates, injury prevalence proportions, and injury incidence proportions. Heterogeneity was assessed using the I2 statistic and the random-effects model.
RESULTS
Of the 7057 studies identified, 4256 were screened after duplicates were removed. A total of 23 studies met the inclusion criteria. Risk of bias was low for 21 studies. The injury incidence rate for elite cricket was 71.9 (SE 21.3, 95% CI 30.2-113.6) injuries per 1000 player hours, time-loss injury incidence rate was 13.3 (SE 4.4, 95% CI 4.6-22.0) injuries per 1000 player hours, and non-time-loss injury incidence rate was 58.5 (SE 16.9, 95% CI 25.6-91.7) injuries per 1000 player hours. The injury prevalence proportion for community to elite cricket was 65.2% (SE 9.3, 95% CI 45.7-82.3) and the injury prevalence proportion for community cricket was 60% (SE 4.5, 95% CI 51.1-68.6). The injury incidence proportion for community cricket was 5.6 (SE 4.4, 95% CI 0.1-18.3) injuries per 10,000 participants. Elite cricket players were more frequently injured than community cricket players. The most prevalent body regions injured were the shoulder and knee, and most were sustained by fast bowlers. Injuries to the hand, wrist, and fingers had the highest incidence and were most sustained by fielders.
CONCLUSIONS
The study's findings can help stakeholders (including players, coaches, clinicians, and policymakers) make informed decisions about cricket participation by informing and implementing strategies to promote cricket as a vehicle for positive public health outcomes. This review also identified gaps in the available evidence base, and addressing these through future research would enhance women's cricket as a professional sport.
SYSTEMATIC REVIEW REGISTRATION NUMBER
PROSPERO CRD42020166052.
Topics: Athletes; Athletic Injuries; Female; Humans; Incidence; Male; Prevalence; Sports
PubMed: 34954723
DOI: 10.11124/JBIES-21-00120