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Women and Birth : Journal of the... Oct 2018Although there is consensus among many that exclusion of pregnant women from clinical research should be justified, there is uncertainty as to whether and why pregnant... (Review)
Review
BACKGROUND
Although there is consensus among many that exclusion of pregnant women from clinical research should be justified, there is uncertainty as to whether and why pregnant women themselves would be willing to participate even if they were found to be eligible. The objective was to identify the reasons why pregnant women participate in clinical research and thereby to distinguish between facilitators and barriers.
METHODS
We conducted a systematic review of articles regarding pregnant women's reasons for participation in clinical research. We used the PubMed/MEDLINE, EMBASE, PsycINFO and CINAHL databases and retrieved additional articles through manually searching the reference lists. We included all articles that reported on pregnant women's reasons for participation in clinical research. We accumulated all reasons that were mentioned in the total of articles and collated them to themes, classifying these themes as a facilitator or a barrier.
RESULTS
The search identified thirty articles that met the inclusion criteria. Themes classified as facilitators: aspirational benefits, collateral benefits, direct benefits, third party influence and lack of inconvenience. Themes classified as barriers: inconveniences, risks, randomisation, lack of trust in research enterprise, medical reasons and third party influence.
CONCLUSIONS
Pregnant women report mostly altruistic and personal reasons for their willingness to participate in clinical research, while barriers primarily relate to inconveniences. It appears that pregnant women's described reasoning is similar to the described reasoning of non-pregnant research subjects. Enhancing the facilitators and overcoming the barriers is the next step to increase the evidence-base underlying maternal and foetal health.
Topics: Clinical Studies as Topic; Female; Humans; Motivation; Patient Selection; Pregnancy; Pregnant Women; Prenatal Care; Research Subjects; Trust
PubMed: 29373261
DOI: 10.1016/j.wombi.2017.12.009 -
Dermatology (Basel, Switzerland) 2023Hidradenitis suppurativa (HS) is a chronic inflammatory disease that disproportionally affects women, as well as Black and biracial individuals. While adalimumab remains...
BACKGROUND
Hidradenitis suppurativa (HS) is a chronic inflammatory disease that disproportionally affects women, as well as Black and biracial individuals. While adalimumab remains the only therapy approved by the Food and Drug Administration for HS, many HS clinical trials for novel and re-tasked therapies are ongoing or upcoming. To optimize treatment equity, reflect the patient population, and facilitate trial participation, it is important to elucidate aspects of clinical trial protocols that may systematically exclude specific patient groups or impose hardships.
OBJECTIVE
The study aimed to systematically review inclusion and exclusion criteria as well as participant demographics in HS clinical trials.
METHODS
A literature search of PubMed, Embase, Cochrane Central, and Web of Science databases was conducted. Peer-reviewed publications of randomized controlled trials that were written in English and had at least 10 participants were included. Title and abstract screening and data extraction were completed by two independent reviewers, with disagreements resolved by a third.
RESULTS
Twenty-three studies totaling 1,496 adult participants met the inclusion criteria. Race and ethnicity were not reported in 473/1,496 (31.6%) and 1,420/1,496 (94.9%) trial participants, respectively. Trial participants were predominantly white (811/1,023, 79.3%) and female (1,057/1,457, 72.5%). The median of each study's average age was 35.7 years (IQR 33.5-38.0), and 17/23 (73.9%) trials excluded pediatric patients. Nearly all participants had Hurley Stage II (499/958, 52.0%) or Hurley Stage III (385/958, 40.2%) disease. Many trials excluded patients who were pregnant (19/23, 82.6%) and breastfeeding (13/23, 56.5%), or who had HS that was "too severe" (8/23, 34.8%) or "too mild" (16/23, 70.0%). Frequently, trial protocols required prolonged washout periods from HS therapies, relatively long duration in the study's placebo arm, and prohibited concurrent analgesic use.
CONCLUSIONS
This systematic review of 23 HS clinical trials totaling 1,496 participants identified substantial hardships imposed by trial participation, high rates of missing race and ethnicity data, and low representation of key patient groups, including those who identify as Black. Future trials with pragmatic study designs, broader inclusion criteria, and study sites in diverse communities may alleviate burdens of trial participation and improve enrollment of diverse patient groups.
Topics: Adult; Humans; Female; Hidradenitis Suppurativa; Clinical Trials as Topic; Adalimumab; Demography; Randomized Controlled Trials as Topic
PubMed: 36108592
DOI: 10.1159/000526069 -
Journal of Science and Medicine in Sport Feb 2020Systematic review of randomized controlled trials.
STUDY DESIGN
Systematic review of randomized controlled trials.
OBJECTIVES
To determine the most effective non-surgical treatment interventions for reducing pain and improving function for patients with patellar tendinopathy.
METHODS
Studies considered for this systematic review were from peer-reviewed journals published between January 2012 and September 2017. All included studies used a visual analogue scale (VAS) to evaluate the participant's pain. The majority of the included studies also used the Victorian Institute of Sport Assessment Patellar Tendinopathy (VISA-P questionnaire) to assess participant's symptoms and function.
RESULTS
Nine randomized controlled trials fit the inclusion criteria and were analyzed. The results of three studies supported the use of isometric exercise to reduce pain immediately. One study found patellar strapping and sports taping to be effective for reduction in pain during sport and immediately after. Eccentric exercise, Dry Needling (DN) (2 studies), injections with Platelet Rich Plasma (PRP), Autologous Blood Injection (ABI), and saline were found to have a more sustained effect on reducing pain and improving knee function.
CONCLUSION
Isometric exercise, patellar strapping, sports taping, eccentric exercise, injections with PRP, ABI, and saline and DN demonstrated a short-term pain relieving and functional improvement effect in subjects with patellar tendinopathy. Longer term follow up on interventions involving eccentric exercise, DN, and injections with PRP, ABI and saline showed sustained pain reduction and improvement in knee function.
LEVEL OF EVIDENCE
Level 1.
Topics: Athletic Tape; Dry Needling; Exercise Therapy; Humans; Pain Measurement; Patellar Ligament; Platelet-Rich Plasma; Randomized Controlled Trials as Topic; Surveys and Questionnaires; Tendinopathy
PubMed: 31606317
DOI: 10.1016/j.jsams.2019.09.008 -
Health Policy (Amsterdam, Netherlands) Dec 2023Collective patient participation, such as patient participation in policy making, has become increasingly important to achieve high-quality care. However, there is... (Review)
Review
INTRODUCTION
Collective patient participation, such as patient participation in policy making, has become increasingly important to achieve high-quality care. However, there is little knowledge on how to let patients participate in a meaningful manner at this level. The aim of this systematic literature review was to provide an overview of barriers, facilitators, and associated impact of collective patient participation.
METHODS
PubMed and EMBASE were searched until May 2023 for studies that evaluated collective patient participation. Study characteristics, methods for patient participation, barriers and facilitators, and impact (if measured) of patient participation were extracted from the articles.
RESULTS
We included 59 articles. Identified barriers and facilitators of collective patient participation were grouped into five categories: (1) preconditions for patient participation, (2) strategy for patient participation, (3) preparation of patients and staff for patient participation, (4) support for patients and staff during patient participation, and (5) evaluation of patient participation. Impact of patient participation was reported in 34 included studies at three levels: quality of care and research, the team and organization, and the participants themselves. Only three studies reported quantitative outcomes.
CONCLUSION
Interestingly, similar challenges were experienced during a period of twenty years, indicating that little progress has been made in structuring patient participation. Our overview of barriers and facilitators will therefore help to improve and structure collective patient participation.
Topics: Humans; Patient Participation; Quality of Health Care; Policy Making
PubMed: 38000333
DOI: 10.1016/j.healthpol.2023.104946 -
Scandinavian Journal of Medicine &... Dec 2014Most people with physical disabilities do not participate in sports regularly, which could increase the chances of developing secondary health conditions. Therefore,... (Review)
Review
Most people with physical disabilities do not participate in sports regularly, which could increase the chances of developing secondary health conditions. Therefore, knowledge about barriers to and facilitators of sports participation is needed. Barriers and facilitators for people with physical disabilities other than amputation or spinal cord injuries (SCI) are unknown. The aim of this study was to provide an overview of the literature focusing on barriers to and facilitators of sports participation for all people with various physical disabilities. Four databases were searched using MeSH terms and free texts up to April 2012. The inclusion criteria were articles focusing on people with physical disabilities, sports and barriers and/or facilitators. The exclusion criteria were articles solely focusing on people with cognitive disabilities, sensory impairments or disabilities related to a recent organ transplant or similar condition. Fifty-two articles were included in this review, with 27 focusing on people with SCI. Personal barriers were disability and health; environmental barriers were lack of facilities, transport and difficulties with accessibility. Personal facilitators were fun and health, and the environmental facilitator was social contacts. Experiencing barriers to and facilitators of sports participation depends on age and type of disability and should be considered when advising people about sports. The extent of sports participation for people with physical disabilities also increases with the selection of the most appropriate sport.
Topics: Disabled Persons; Fatigue; Health Status; Humans; Motivation; Relaxation; Self Efficacy; Social Participation; Sports; Time Factors; Transportation
PubMed: 24730752
DOI: 10.1111/sms.12218 -
Psychology of Sport and Exercise May 2024Despite the well-documented health, social and economic benefits of sports participation, adults' participation in organised sport declines as age increases. To date, no... (Review)
Review
Despite the well-documented health, social and economic benefits of sports participation, adults' participation in organised sport declines as age increases. To date, no review has summarised the multi-level factors that influence adults' decisions to participate in sport. Therefore, this systematic literature review aimed to: 1) determine the facilitators, constraints and negotiated constraints to adults' (25-64 years) sport participation, and 2) summarise these factors according to the multiple levels of the social-ecological model. A total of 91 articles were identified following an extensive literature search conducted according to the PRISMA guidelines. Studies were published over four decades (1983-2023), predominantly located in North America (n = 45; 49.5%), ranged from 5 to 10,646 participants, examined mainly middle-aged adults (M = 35-44 years; n = 52; 48.6%), included more males (61.6%) than females (38.1%), and were conducted in primarily single sport contexts (n = 63; 69.2%). Overall, more unique facilitators (55 items) were identified than constraints (35 items) and negotiated constraints (13 items). The desire for improved health and enjoyment were the most frequently reported facilitators, and the main constraints were injury or illness and family commitments. Constraint negotiation strategies largely included individual (e.g., implementing financial strategies) and interpersonal factors (e.g., encouraging others to participate). This review highlighted the expansive multi-level factors that influence adults' sports participation, reiterated the complexity of developing appropriate sport offerings, and identified a lack of studies examining non-sport participants. Strategies to support adult sport participation should focus on enjoyment, consider co-designed sport modifications to alleviate perceived constraints and integrate behaviour change theory to foster positive sport participation habits.
Topics: Adult; Male; Middle Aged; Female; Humans; Sports; Health Behavior; Habits; North America
PubMed: 38360078
DOI: 10.1016/j.psychsport.2024.102609 -
Medicine Aug 2022Successful recruitment of participants into clinical research has always been challenging and is affected by many factors. This systematic review aimed to explore the...
INTRODUCTION
Successful recruitment of participants into clinical research has always been challenging and is affected by many factors. This systematic review aimed to explore the perceptions and attitudes as well as identify the factors affecting the participation in clinical research among the Eastern Mediterranean Regional Office countries' population.
METHODS
A systematic search of the literature was conducted to explore attitudes or perceptions of the general public or patients towards participation in clinical research. PubMed, Pro-Quest Central, World Health Organizations Index Medicus for the Eastern Mediterranean Region, and Google Scholar were searched. Studies were considered eligible for inclusion if they presented primary data and were conducted in one of the Eastern Mediterranean Regional Office countries. A data extraction sheet was used to record the following: year, country, aim, population, sample size, study design, data collection, and setting. The identified factors from the included studies were categorized into motivators and barriers.
RESULTS
In total, 23 original research articles were identified that addressed perceptions or attitudes towards clinical research participation. Six main motivators and barriers of research participation among patients, the general public, and patient family members were identified. The most common cited motivators included personal benefits to the individual, altruism and the desire to help others, the research process, the influence of the physician, family encouragement, and religion. Concerns regarding safety, confidentiality, and other factors in addition to the research process, lack of trust in healthcare providers or healthcare system, lack of interest in research and no perceived personal benefit, religious concerns, and family/cultural concerns were the most cited barriers to participation.
CONCLUSION
The identified motivators and barriers are essential to tackle during clinical research planning among the population of Eastern Mediterranean Regional Office countries. Further research is needed to assess the attitudes and perceptions of individuals approached to participate in trials.
Topics: Health Knowledge, Attitudes, Practice; Humans; Physicians; Religion; Sample Size; Trust
PubMed: 35984206
DOI: 10.1097/MD.0000000000029959 -
International Journal of Sports Medicine Jun 2023Urinary incontinence (UI) in female athletes can impair their quality-of-life (QoL) and reduce their participation in sports. This review aims to evaluate the effect of...
Urinary incontinence (UI) in female athletes can impair their quality-of-life (QoL) and reduce their participation in sports. This review aims to evaluate the effect of pelvic floor muscle training (PFMT) in treating UI in women participating in high-impact sports. Furthermore, to assess the influence of PFMT on pelvic floor muscles (PFM) function and the UI impact on their QoL. For this purpose, a systematic review of randomized controlled trials (RCTs) and non-RCTs was performed. An electronic search was conducted on PubMed, EMBASE, SciELO, and Scopus. The quality of evidence was assessed using the PEDro and ROBINS-I scales. The Consensus on Exercise Reporting Template (CERT) was used to assess the quality of PFMT protocols. All studies were available in full-text including incontinent female participants who are practitioners of high-impact sports, investigating PFMT vs control groups(inactive) or undergoing other treatments. Three RCTs and two non-RCTs (104 participants) were analyzed. PFMT provided a significant improvement in UI symptoms with a reduction in the frequency (n=3) and the amount of UI (n=5). PFM function was assessed in three studies, and two found improvement in maximal contraction and one in vaginal resting pressure in favor of PFMT. None of the two studies that assessed QoL found a difference after PFMT intervention.
Topics: Female; Humans; Pelvic Floor; Exercise Therapy; Urinary Incontinence; Sports; Exercise; Treatment Outcome; Urinary Incontinence, Stress
PubMed: 36075371
DOI: 10.1055/a-1939-4798 -
Ciencia & Saude Coletiva Feb 2014The process of democratization of Brazil contributed to the emergence of management councils and thematic conferences in the context of public health policies. The scope... (Review)
Review
The process of democratization of Brazil contributed to the emergence of management councils and thematic conferences in the context of public health policies. The scope of this article was to conduct a systematic review of the literature in order to establish the factors associated with the process of institutionalization of these democratic areas. The following databases were researched: LILACS, IBECS, MEDLINE, SciELO, PAHO, PsycINFO, Web of Science, Social Science and EBSCO. For the composition of the sample of 25 articles, the following key words were used: Social Control, Social Participation, Consumer Participation, Community Participation, Public Participation, Citizen Participation, Political Participation, Participative Management, Participative Democracy, Deliberative Democracy with Health Councils and Health Conferences. The results found synthesize a set of categories that has impacted the participatory public spaces: political representation and qualification, relationships among the social actors, institutional design, political culture, discourses about health/disease and the debate about democracy. The findings help to move forward in the understanding of such institutions, fostering the construction of alternatives committed to the strengthening of democracy in Brazil.
Topics: Brazil; Community Participation; Delivery of Health Care; Humans; Social Participation
PubMed: 24863826
DOI: 10.1590/1413-81232014192.10542012 -
Journal of Global Health Jan 2023A growing global shortage of health workers is limiting access to health care, especially in resource-limited countries. Family participation in hospital care could...
BACKGROUND
A growing global shortage of health workers is limiting access to health care, especially in resource-limited countries. Family participation in hospital care could enhance care while tackling health worker shortages. With the same resources, it might deliver additional and more personalised care. This review assessed the effect and safety of family participation interventions in the care of hospitalised adults in resource-limited settings and, ultimately, if it is a viable strategy to tackle health worker shortages.
METHODS
For this systematic review, Medline, Embase, CINAHL and the Global Health Library were searched from inception till April 7, 2022. Clinical studies were included if they described a family participation intervention for hospitalised adults, were performed in a low- or middle-income country and reported on a patient-related outcome. Data were collected on patient, family, staff and health service-related outcomes. Risk of bias was assessed with the ROB2 and ROBINS-I tool.
RESULTS
From 4444 studies, six were included for narrative synthesis, with a total of 1794 participants. Four studies were performed in Asia and two in Africa; all were published between 2017 and 2022. In-hospital family participation interventions aimed at medication administration and adherence, delirium prevention, and palliative cancer care were successful in significantly improving patient outcomes. Involving family in post-stroke rehabilitation interventions showed no significant effect on mortality and long-term disability. Few data were reported on participating family members' outcomes or hospital staffing issues. None of the included studies showed harm from family participation.
CONCLUSIONS
The limited data suggest that family participation can be effective and safe in specific contexts. However, more research is needed to determine the effect of family participation and justify further implementation. Family participation research for enhancing care while tackling health worker shortages should be a collaborative priority of researchers, health care professionals, funding agencies and policymakers.
REGISTRATION
PROSPERO registration No. CRD42020205878.
Topics: Adult; Humans; Delivery of Health Care; Family; Hospitals; Developing Countries; Personnel, Hospital
PubMed: 36655879
DOI: 10.7189/13.04005