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The Oncologist May 2021Drug development in oncology has broadened from mainly considering randomized clinical trials to also including single-arm trials tailored for very specific subtypes of...
Drug development in oncology has broadened from mainly considering randomized clinical trials to also including single-arm trials tailored for very specific subtypes of cancer. They often use historical controls, and this article discusses benefits and risks of this paradigm and provide various regulatory and statistical considerations. While leveraging the information brought by historical controls could potentially shorten development time and reduce the number of patients enrolled, a careful selection of the past studies, a prespecified statistical analysis accounting for the heterogeneity between studies, and early engagement with regulators will be key to success. Although both the European Medicines Agency and the U.S. Food and Drug Administration have already approved medicines based on nonrandomized experiments, the evidentiary package can be perceived as less comprehensive than randomized experiments. Use of historical controls, therefore, is better suited for cases of high unmet clinical need, where the disease course is well characterized and the primary endpoint is objective. IMPLICATIONS FOR PRACTICE: Incorporating historical data in single-arm oncology trials has the potential to accelerate drug development and to reduce the number of patients enrolled, compared with standard randomized controlled clinical trials. Given the lack of blinding and randomization, such an approach is better suited for cases of high unmet clinical need and/or difficult experimental situations, in which the trajectory of the disease is well characterized and the endpoint can be measured objectively. Careful pre-specification and selection of the historical data, matching of the patient characteristics with the concurrent trial data, and innovative statistical methodologies accounting for between-study variation will be needed. Early engagement with regulators (e.g., via Scientific Advice) is highly recommended.
Topics: Humans; Medical Oncology; Neoplasms; Research Design
PubMed: 33523511
DOI: 10.1002/onco.13696 -
Qualitative Health Research Apr 2022Photovoice has gained acceptance as a viable visual method to engage community members as partners in research. However, as methods associated with photovoice have...
Photovoice has gained acceptance as a viable visual method to engage community members as partners in research. However, as methods associated with photovoice have developed and evolved over time, concerns have also been raised with regard to how this impacts the methodological underpinnings on which photovoice rests. The aim of this article is to explore the meaning of dialogue and action as methodologically pivotal for the relevance of photovoice as community-based participatory research; further, using an empirical case and narrative theory, we attempt to contribute to an understanding of the processes that facilitate the viability and relevance of photovoice. By unpacking the contributions of dialogue and action towards a participatory methodology, in this case photovoice, the authors illustrate and argue for aspects critical in photovoice. Drawing on these aspects provides an arena for storytelling and story making, which have not previously had an explicit part in photovoice.
Topics: Communication; Community-Based Participatory Research; Humans; Narration; Photography; Research Design
PubMed: 35245157
DOI: 10.1177/10497323221077300 -
Human Brain Mapping Jun 2023Transcranial magnetic stimulation (TMS) with electroencephalography (EEG), that is TMS-EEG, may assist in managing epilepsy. We systematically reviewed the quality of... (Review)
Review
Transcranial magnetic stimulation (TMS) with electroencephalography (EEG), that is TMS-EEG, may assist in managing epilepsy. We systematically reviewed the quality of reporting and findings in TMS-EEG studies on people with epilepsy and healthy controls, and on healthy individuals taking anti-seizure medication. We searched the Cochrane Library, Embase, PubMed and Web of Science databases for original TMS-EEG studies comparing people with epilepsy and healthy controls, and healthy subjects before and after taking anti-seizure medication. Studies should involve quantitative analyses of TMS-evoked EEG responses. We evaluated the reporting of study population characteristics and TMS-EEG protocols (TMS sessions and equipment, TMS trials and EEG protocol), assessed the variation between protocols, and recorded the main TMS-EEG findings. We identified 20 articles reporting 14 unique study populations and TMS methodologies. The median reporting rate for the group of people with epilepsy parameters was 3.5/7 studies and for the TMS parameters was 13/14 studies. TMS protocols varied between studies. Fifteen out of 28 anti-seizure medication trials in total were evaluated with time-domain analyses of single-pulse TMS-EEG data. Anti-seizure medication significantly increased N45, and decreased N100 and P180 component amplitudes but in marginal numbers (N45: 8/15, N100: 7/15, P180: 6/15). Eight articles compared people with epilepsy and controls using different analyses, thus limiting comparability. The reporting quality and methodological uniformity between studies evaluating TMS-EEG as an epilepsy biomarker is poor. The inconsistent findings question the validity of TMS-EEG as an epilepsy biomarker. To demonstrate TMS-EEG clinical applicability, methodology and reporting standards are required.
Topics: Humans; Transcranial Magnetic Stimulation; Electroencephalography; Epilepsy; Research Design; Biomarkers
PubMed: 36896753
DOI: 10.1002/hbm.26260 -
Journal of the American Board of Family... 2019This issue of the evidences the wide variety of research methods that can effectively answer questions important to the practice of family medicine. For example, this...
This issue of the evidences the wide variety of research methods that can effectively answer questions important to the practice of family medicine. For example, this issue includes 4 highly informative reports from qualitative or mix-methods research, plus surveys, a meta-analysis, a case report, and more. Mixed-methods were used to look at practice changes and to compare advance directive tools. Surveys were used to identify practical, but addressable, issues for mailed colon cancer screening tests, and the prevalence of atopic dermatitis, and emollient use in young children. Secondary analyses of national surveys were used to identify low-value patient requests, and how diabetes and prediabetes are being treated. Retrospective chart analysis of patients with frequent hospital admissions identified important characteristics of the patients and their problems. Meta-analysis methodology was used to stratify risks for pneumonia. And, a randomized trial was used to compare ways to train patients to use medical record patient portals.
Topics: Family Practice; Humans; Research Design
PubMed: 30850447
DOI: 10.3122/jabfm.2019.02.190005 -
BMC Medical Ethics Mar 2015Despite the increased prevalence of bioethics research that seeks to use empirical data to answer normative research questions, there is no consensus as to what an... (Review)
Review
BACKGROUND
Despite the increased prevalence of bioethics research that seeks to use empirical data to answer normative research questions, there is no consensus as to what an appropriate methodology for this would be. This review aims to search the literature, present and critically discuss published Empirical Bioethics methodologies.
METHODS
MedLine, Web of Science and Google Scholar were searched between 15/02/12 and 16/06/13 to find relevant papers. These were abstract reviewed independently by two reviewers with papers meeting the inclusion criteria subjected to data extraction.
RESULTS
33 publications (32 papers and one book chapter) were included which contained 32 distinct methodologies. The majority of these methodologies (n = 22) can be classed as either dialogical or consultative, and these represent two extreme 'poles' of methodological orientation. Consideration of these results provoked three central questions that are central to the planning of an empirical bioethics study, and revolve around how a normative conclusion can be justified, the analytic process through which that conclusion is reached, and the kind of conclusion that is sought.
CONCLUSION
When considering which methodology or research methods to adopt in any particular study, researchers need to think carefully about the nature of the claims they wish to generate through their analyses, and how these claims align with the aims of the research. Whilst there are superficial similarities in the ways that identical research methods are made use of, the different meta-ethical and epistemological commitments that undergird the range of methodological approaches adopted rehearse many of the central foundational disagreements that play out within moral philosophy and bioethical analysis more broadly. There is little common ground that transcends these disagreements, and we argue that this is likely to present a challenge for the legitimacy of the bioethical enterprise. We conclude, however, that this heterogeneity ought to be welcomed, but urge those involved in the field to engage meaningfully and explicitly with questions concerning what kinds of moral claim they want to be able to make, about normative justification and the methodological process, and about the coherence of these components within their work.
Topics: Bioethical Issues; Bioethics; Empirical Research; Ethical Analysis; Ethical Theory; Humans; Morals; Research Design
PubMed: 25885575
DOI: 10.1186/s12910-015-0010-3 -
Complementary Therapies in Medicine May 2022Hypnotherapy is increasingly used in general medicine in France to manage health problems such as insomnia. There is some evidence to support the efficacy of hypnosis in... (Review)
Review
INTRODUCTION
Hypnotherapy is increasingly used in general medicine in France to manage health problems such as insomnia. There is some evidence to support the efficacy of hypnosis in treating insomnia but this evidence is based on methodologies of various strengths. This review aims to explore the methodological elements employed in hypnotherapy research to manage insomnia.
METHOD
We performed a narrative review of the literature using systematic review methods focusing on treating insomnia with hypnosis. PubMed, Psycinfo, BASE and Cochrane databases and Google scholar were searched.
RESULTS
Overall, 25 studies were included consisting of 10 case studies, 11 randomised, controlled trials and 4 pre and post intervention studies. The study designs, intervention, control and comparators were heterogeneous, as were the hypnosis definitions and techniques. Also, detailed descriptions of the hypnosis techniques were lacking. Most studies used non-quantifiable measurement criteria and sample numbers were too small to show significance or be representative. No double-blind study was found.
CONCLUSION
Our results indicate that the current research concerning the efficacy of hypnosis to relieve insomnia is lacking in key methodological elements. The evaluation research process requires robust methodology. We propose applying the IDEAL framework, which recommends research steps to evaluate non-pharmacological and other complex therapies to evaluate the efficacy of hypnosis to manage insomnia.
Topics: Databases, Factual; France; Humans; Hypnosis; Research Design; Sleep Initiation and Maintenance Disorders
PubMed: 35074550
DOI: 10.1016/j.ctim.2022.102805 -
Developmental Medicine and Child... May 2023
Topics: Humans; Disabled Persons; Research Design
PubMed: 37005555
DOI: 10.1111/dmcn.15534 -
Journal of Comparative Effectiveness... Mar 2014Health disparities are an important and continuing problem of considerable research importance. Comparative effectiveness research (CER) is an excellent vehicle to... (Review)
Review
Health disparities are an important and continuing problem of considerable research importance. Comparative effectiveness research (CER) is an excellent vehicle to evaluate interventions to remedy disparities. We classify CER for disparities at three levels of science: basic biology, care and systems, and social and cultural context. In basic biology, genomics will delineate treatments for specific individuals and populations. Care and systems interventions are most important research areas to improve process and quality measures. However, there is evidence that correction of healthcare processes disparities will not be sufficient to improve health and that social and cultural research may be key in this regard. The methodology of CER for disparities is the same as that of other research with randomized controlled trials the gold standard and database analysis, and other observational and quasi-experimental methods important and effective. In addition, mixed methods and multilevel modeling offer promise. Community involvement in research and patient preferences among high-quality choices need to be included in planning of CER.
Topics: Comparative Effectiveness Research; Healthcare Disparities; Humans; Research Design
PubMed: 24645691
DOI: 10.2217/cer.14.1 -
BMJ Open Jun 2022There is growing emphasis on the importance of both the cognitive and behavioural phenomenon of attention for clinicians engaged in patient care. Aspects of attention...
INTRODUCTION
There is growing emphasis on the importance of both the cognitive and behavioural phenomenon of attention for clinicians engaged in patient care. Aspects of attention such as cognitive load, distraction and task switching have been studied in various settings with different methodologies. Using the protocol described here, we aim to systematically review the medical literature in order to map the concept of attention and to synthesise diverse concepts and methods under the broader category of research focused on 'attention'.
METHODS AND ANALYSIS
Following the methodology described by the Joanna Briggs Institute and Arksey and O'Malley, our scoping review conducts an iterative search of Cumulative Index of Nursing and Allied Health Literature (CINAHL), Medline (PubMed) and EMBASE (Ovid). An initial limited search based on key concepts and terminology will generate relevant articles which in turn will be mined for additional keywords and index terms to guide a formal literature search. Our multidisciplinary team will extract data into a matrix, including a small random sample of the same studies (to ensure concordance), and present the results in a descriptive narrative format.
ETHICS AND DISSEMINATION
As a secondary analysis, our study does not require ethics approval, and we will ensure that included studies have appropriate approval. We anticipate results will identify diverse ways of conceptualising clinician attention and will provide a foundation for developing additional metrics and study methods to optimise attention in the clinical environment. We will disseminate results through journals and conferences and coordinate with colleagues doing work in adjacent fields.
Topics: Attention; Benchmarking; Humans; Research Design; Review Literature as Topic
PubMed: 35697461
DOI: 10.1136/bmjopen-2021-052334 -
The Cochrane Database of Systematic... Jan 2008Systematic reviews are most helpful if they are up-to-date. We did a systematic review of strategies and methods describing when and how to update systematic reviews. (Review)
Review
BACKGROUND
Systematic reviews are most helpful if they are up-to-date. We did a systematic review of strategies and methods describing when and how to update systematic reviews.
OBJECTIVES
To identify, describe and assess strategies and methods addressing: 1) when to update systematic reviews and 2) how to update systematic reviews.
SEARCH STRATEGY
We searched MEDLINE (1966 to December 2005), PsycINFO, the Cochrane Methodology Register (Issue 1, 2006), and hand searched the 2005 Cochrane Colloquium proceedings.
SELECTION CRITERIA
We included methodology reports, updated systematic reviews, commentaries, editorials, or other short reports describing the development, use, or comparison of strategies and methods for determining the need for updating or updating systematic reviews in healthcare.
DATA COLLECTION AND ANALYSIS
We abstracted information from each included report using a 15-item questionnaire. The strategies and methods for updating systematic reviews were assessed and compared descriptively with respect to their usefulness, comprehensiveness, advantages, and disadvantages.
MAIN RESULTS
Four updating strategies, one technique, and two statistical methods were identified. Three strategies addressed steps for updating and one strategy presented a model for assessing the need to update. One technique discussed the use of the "entry date" field in bibliographic searching. Statistical methods were cumulative meta-analysis and predicting when meta-analyses are outdated.
AUTHORS' CONCLUSIONS
Little research has been conducted on when and how to update systematic reviews and the feasibility and efficiency of the identified approaches is uncertain. These shortcomings should be addressed in future research.
Topics: Meta-Analysis as Topic; Practice Guidelines as Topic; Review Literature as Topic; Time Factors
PubMed: 18254126
DOI: 10.1002/14651858.MR000023.pub3