Observational research, randomised trials, and two views of medical science.
Ontology highlight
ABSTRACT:
SUBMITTER: Vandenbroucke JP
PROVIDER: S-EPMC2265762 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundSeveral reviews of published cluster randomised trials have reported that about half did not take clustering into account in the analysis, which was thus incorrect and potentially misleading. In this paper I ask whether cluster randomised trials are increasing in both number and quality of reporting.MethodsComputer search for papers on cluster randomised trials since 1980, hand search of trial reports published in selected volumes of the British Medical Journal over 20 years.ResultsThere has been a large increase in the numbers of methodological papers and of trial reports using the term 'cluster random' in recent years, with about equal numbers of each type of paper. The British Medical Journal contained more such reports than any other journal. In this journal there was a corresponding increase over time in the number of trials where subjects were randomised in clusters. In 2003 all reports showed awareness of the need to allow for clustering in the analysis. In 1993 and before clustering was ignored in most such trials.ConclusionCluster trials are becoming more frequent and reporting is of higher quality. Perhaps statistician pressure works.
| S-EPMC515302 | biostudies-literature
Project description:Since the latter part of the 1990's, the English-speaking medical education community has been engaged in a debate concerning the types of research that should have priority. To shed light on this debate and to better understand its implications for the practice of research, 23 semi-structured interviews were conducted with "influential figures" from the community. The results were analyzed using the concept of "field" developed by the sociologist Pierre Bourdieu. The results reveal that a large majority of these influential figures believe that research in medical education continues to be of insufficient quality despite the progress that has taken place over the past 2 decades. According to this group, studies tend to be both redundant and opportunistic, and researchers tend to have limited understanding of both theory and methodological practice from the social sciences. Three factors were identified by the participants to explain the current problems in research: the working conditions of researchers, budgetary restraints in financing research in medical education, and the conception of research in the medical environment. Two principal means for improving research are presented: intensifying collaboration between PhD's and clinicians, and encouraging the diversification of perspectives brought to bear on research in medical education.
| S-EPMC2779425 | biostudies-other
Project description:BACKGROUND:Despite efforts to improve the accuracy and transparency of the design, conduct, and reporting of randomised controlled trials (RCTs), deficiencies remain. Such deficiencies contribute to significant, avoidable waste of health research investment and impede reproducibility. This study aimed to synthesise and critically analyse changes over time in the conduct and reporting of internationally published evidence on patient and/or population health-oriented RCTs conducted in one country. METHODS:This observational study drew on systematic review methods. We searched six databases for published RCTs (database inception to December 2018) where ??80% of participants were recruited in the Republic of Ireland. RCTs of interventions targeted at patients, providers and/or policy makers intended to improve health, healthcare or health research were included. For each study, screening, data extraction and methodological quality appraisal were conducted by one member of the author team. RESULTS:From 17,560 titles and abstracts, 752 unique RCTs were published in 745 papers between 1968 and 2018, with a steady year-on-year increase since 1968. The number of participants was in the range of 2-8628. The majority were parallel design (86%) and classified as treatment evaluation. Of the 418 RCTs published since the introduction of mandatory clinical trial registration by the International Committee of Medical Journal Editors in 2005, 32% (n =?134) provided a trial registration number. This increased to 47% when taking studies published between 2013 and 2018 (n =?232). Since the 1996 publication of the CONSORT statement, 16% of included RCTs made specific reference to a standardised reporting guideline and this increased to 31% for more recent studies published between 2013 and 2018. Overall, 7% (n =?53) of studies referred to a published study protocol, increasing to 20% for studies published between 2013 and 2018. CONCLUSION:Evidence from this single-country study of RCTs published in the international literature suggests that both the number overall, the number registered and the number referencing reporting guidelines have increased steadily over time. Despite widespread endorsement of reporting standards, reporting of RCTs remains suboptimal in domains such as compliance with the CONSORT statement and prospective trial registration. Researchers, funders and journal editors, nationally and internationally, should continue to focus on improving reporting and examining avoidable waste of health research investment.
| S-EPMC7278139 | biostudies-literature
Project description:BackgroundMedical students engage in curricular and extracurricular activities, including undergraduate research (UR). The advantages, difficulties and motivations for medical students pursuing research activities during their studies have rarely been addressed. In Brazil, some medical schools have included undergraduate research into their curriculum. The present study aimed to understand the reality of scientific practice among medical students at a well-established Brazilian medical school, analyzing this context from the students' viewpoint.MethodsA cross-sectional survey based on a questionnaire applied to students from years one to six enrolled in an established Brazilian medical school that currently has no curricular UR program.ResultsThe questionnaire was answered by 415 students, 47.2% of whom were involved in research activities, with greater participation in UR in the second half of the course. Independent of student involvement in research activities, time constraints were cited as the main obstacle to participation. Among students not involved in UR, 91.1% said they favored its inclusion in the curriculum, since this would facilitate the development of such activity. This approach could signify an approximation between the axes of teaching and research. Among students who had completed at least one UR project, 87.7% said they would recommend the activity to students entering the course.ConclusionEven without an undergraduate research program, students of this medical school report strong involvement in research activities, but discussion of the difficulties inherent in its practice is important to future developments.
| S-EPMC4021277 | biostudies-literature
Project description:ObjectivesTo explore stakeholders' perceptions of decision aids designed to support the informed consent decision-making process for randomised controlled trials.DesignQualitative semistructured interviews. Participants were provided with prototype trial decision aids in advance to stimulate discussion. Interviews were analysed using an established interpretive approach.Participants23 stakeholders: Trial Managers (n=5); Research Nurses (n=5); Ethics Committee Chairs (n=5); patients (n=4) and Clinical Principal Investigators (n=4).SettingEmbedded within two ongoing randomised controlled trials. All interviews conducted with UK-based participants.ResultsCertain key aspects (eg, values clarification exercises, presentation of probabilities, experiences of others and balance of options) in the prototype decision aids were perceived by all stakeholders as having a significant advantage (over existing patient information leaflets) in terms of supporting well informed appropriate decisions. However, there were some important differences between the stakeholder groups on specific content (eg, language used in the section on positive and negative features of taking part in a trial and the overall length of the trial decision aids). Generally the stakeholders believed trial decision aids have the potential to better engage potential participants in the decision-making process and allow them to make more personally relevant decisions about their participation.ConclusionsCompared to existing patient information leaflets, stakeholders perceived decision aids for trial participation to have the potential to promote a more 'informed' decision-making process. Further efforts to develop, refine and formally evaluate trial decision aids should be explored.
| S-EPMC4139633 | biostudies-literature
Project description:IntroductionThe American University of Beirut Medical Center (AUBMC) developed the Fellowship and Residency Research Program (FRRP) to provide residents and clinical fellows with a supervised and structured research experience. The objective of this study was to explore the views of FRRP participants about the training program and how to enhance it.MethodsIn 2018, we conducted a qualitative study targeting residents where we invited potential participants through email and via snowball sampling. We continued the data collection until we reached data saturation with 21 participants (N = 21) and used thematic analysis to identify emerging themes.ResultsThematic analysis generated four emerging themes: one related to the expectations of residents, while the remaining three themes related to how the program is working to meet those expectations, specifically: coordination, mentorship, and capacity building. For these three latter themes, we discussed the strengths and challenges related to each. In terms of coordination, few residents complained that the deadlines to submit deliverables are not evenly distributed across the years. In terms of mentorship, participants appreciated the flexibility in choosing the mentor. In terms of capacity building activities, participants found the lecture series, both real time and virtual, to be helpful. Finally, participants pointed out that the FRRP program should be mandatory.DiscussionTo provide residents and clinical fellows with a supervised and structured research experience, we have built on our findings to introduce several changes to our program such as ensuring the availability and commitment of faculty mentors, and providing capacity building activities to the program participants.
| S-EPMC8782500 | biostudies-literature
Project description:BackgroundRecruitment of patients is one of the main challenges when designing and conducting randomised controlled trials (RCTs). Trials of rare injuries or those that include surgical interventions pose added challenges due to the small number of potentially eligible patients and issues with patient preferences and surgeon equipoise. We explore key issues to consider when recruiting to orthopaedic surgical trials from the perspective of staff and patients with the aim of informing the development of strategies to improve recruitment in future research.DesignTwo qualitative process evaluations of a UK-wide orthopaedic surgical RCT (ACTIVE) and mixed methods randomised feasibility study (PRESTO). Qualitative semi-structured interviews were conducted and data was analysed thematically.SettingNHS secondary care organisations throughout the UK. Interviews were undertaken via telephone.ParticipantsThirty-seven health professionals including UK-based spinal and orthopaedic surgeons and individuals involved in recruitment to the ACTIVE and PRESTO studies (e.g. research nurses, surgeons, physiotherapists). Twenty-two patients including patients who agreed to participate in the ACTIVE and PRESTO studies (n=15) and patients that declined participation in the ACTIVE study (n=7) were interviewed.ResultsWe used a mixed methods systematic review of recruiting patients to randomised controlled trials as a framework for reporting and analysing our findings. Our findings mapped onto those identified in the systematic review and highlighted the importance of equipoise, randomisation, communication, patient's circumstances, altruism and trust in clinical and research teams. Our findings also emphasised the importance of considering how eligibility criteria are operationalised and the impact of complex patient pathways when recruiting to surgical trials. In particular, the influence of health professionals, who are not involved in trial recruitment, on patients' treatment preferences by suggesting they would receive a certain treatment ahead of recruitment consultations should not be underestimated.ConclusionsA wealth of evidence exploring factors affecting recruitment to randomised controlled trials exists. A methodological shift is now required to ensure that this evidence is used by all those involved in recruitment and to ensure that existing knowledge is translated into methods for optimising recruitment to future trials.Trial registrationACTIVE: ( ISRCTN98152560 ). Registered on 06/03/2018. PRESTO: ( ISRCTN12094890 ). Registered on 22/02/2018.
| S-EPMC8285860 | biostudies-literature
Project description:BackgroundConsenting for retrospective medical records-based research (MR) and leftover tissue-based research (TR) continues to be controversial. Our objective was to survey Saudis attending outpatient clinics at a tertiary care hospital on their personal preference and perceptions of norm and current practice in relation to consenting for MR and TR.MethodsWe surveyed 528 Saudis attending clinics at a tertiary care hospital in Saudi Arabia to explore their preferences and perceptions of norm and current practice. The respondents selected one of 7 options from each of 6 questionnaires.ResultsRespondents' mean (SD) age was 33 (11) years, 42% were males, 56% were patients, 84% had ? secondary school education, and 10% had previously volunteered for research. Respectively, 40% and 49% perceived that the norm is to conduct MR and TR without consent and 38% and 37% with general or proposal-specific consent; the rest objected to such research. There was significant difference in the distribution of choices according to health status (patients vs. companions) for MR (adjusted Kruskal-Wallis test P = 0.03) but not to age group, gender, education level, or previous participation in research (unadjusted P = 0.02 - 0.59). The distributions of perceptions of current practice and norm were similar (unadjusted Marginal Homogeneity test P = 0.44 for MR and P = 0.89 for TR), whereas the distributions of preferences and perceptions of norm were different (adjusted P = 0.09 for MR and P = 0.02 for TR). The distributions of perceptions of norm, preferences, and perceptions of current practice for MR were significantly different from those of TR (adjusted P < 0.009 for all).ConclusionsWe conclude that: 1) there is a considerable diversity among Saudi views regarding consenting for retrospective research which may be related to health status, 2) the distribution of perceptions of norm was similar to the distribution of perceptions of current practice but different from that of preferences, and 3) MR and TR are perceived differently in regard to consenting.
| S-EPMC2974743 | biostudies-literature
Project description:We established patient-derived organoids and monolayer culture cells from the salivary gland cancer cases. To compare the RNA profiles of primary culture cells (Organoids and monolayer culture cells) and their parental tumors, we isolated total RNA from 2 cases of the salivary gland cancer and performed transcriptome sequencing for the organoids, monolayer culture cells, and their parental tumors of both cases. Case 6 is a case of adenoid cystic carcinoma and Case 11 is a case of salivary duct carcinoma.
2023-04-27 | GSE223554 | GEO
Project description:In the United States, the wide ideological divergence in public confidence in science poses a potentially significant problem for the scientific enterprise. We examine the behavioral consequences of this ideological divide for Americans' contributions to medical research. Based on a mass survey of American adults, we find that engagement in a wide range of medical research activities is a function of a latent propensity to participate. The propensity is systematically higher among liberals than among conservatives. A substantial part of this ideological divide is due to conservative Americans' lower confidence in science. These findings raise important issues for the recruitment of subjects for medical studies and the generalizability of results from such studies.
| S-EPMC7862386 | biostudies-literature