Review Of Methodological Considerations Research Articles

Ex vivo therapeutic screening of metastatic cSCC: A review of methodological considerations for clinical implementation.

Cutaneous squamous cell carcinoma (cSCC) is the second most common malignancy worldwide, with most deaths caused by locally advanced and metastatic disease. Treatment of resectable metastases is typically limited to invasive surgery with adjuvant radiotherapy; however, many patients fail to respond and there is minimal data to predict response or propose effective alternatives. Precision medicine could improve this, though genomic biomarkers remain elusive in the high mutational background and genomic complexity of cSCC. A phenotypic approach to precision medicine using patient-derived exvivo tumour models is gaining favour for its capacity to directly assess biological responses to therapeutics as a functional, predictive biomarker. However, the use of exvivo models for guiding therapeutic selection has yet to be employed for metastatic cSCC. This review will therefore evaluate the existing experimental models of metastatic cSCC and discuss how exvivo methods could overcome the shortcomings of these existing models. Disease-specific considerations for a prospective methodological pipeline will also be discussed in the context of precision medicine.

A Narrative Review of Methodological Considerations in Magnetic Resonance Imaging of Offspring Brain Development and the Influence of Parenting.

Parenting has been robustly associated with offspring psychosocial development, and these effects are likely reflected in brain development. This hypothesis is being tested with increasingly rigorous methods and the use of magnetic resonance imaging, a powerful tool for characterizing human brain structure and function. The objective of this narrative review was to examine methodological issues in this field that impact the conclusions that can be drawn and to identify future directions in this field. Studies included were those that examined associations between parenting and offspring brain structure or function. Results show four thematic features in this literature that impact the hypotheses that can be tested, and the conclusions drawn. The first theme is a limited body of studies including repeated sampling of offspring brain structure and function, and therefore an over-reliance on cross-sectional or retrospective associations. The second involves a focus on extremes in early life caregiving, limiting generalizability. The third involves the nature of parenting assessment, predominantly parent- or child-report instead of observational measures which may be more ecologically valid measures of parenting. A closely related fourth consideration is the examination of detrimental versus positive parenting behaviors. While studies with one or more of these thematic limitations provide valuable information, future study design should consider addressing these limitations to determine how parenting shapes offspring brain development.

Steady-State Visually Evoked Potentials and Feature-based Attention: Preregistered Null Results and a Focused Review of Methodological Considerations.

Feature-based attention is the ability to selectively attend to a particular feature (e.g., attend to red but not green items while looking for the ketchup bottle in your refrigerator), and steady-state visually evoked potentials (SSVEPs) measured from the human EEG signal have been used to track the neural deployment of feature-based attention. Although many published studies suggest that we can use trial-by-trial cues to enhance relevant feature information (i.e., greater SSVEP response to the cued color), there is ongoing debate about whether participants may likewise use trial-by-trial cues to voluntarily ignore a particular feature. Here, we report the results of a preregistered study in which participants either were cued to attend or to ignore a color. Counter to prior work, we found no attention-related modulation of the SSVEP response in either cue condition. However, positive control analyses revealed that participants paid some degree of attention to the cued color (i.e., we observed a greater P300 component to targets in the attended vs. the unattended color). In light of these unexpected null results, we conducted a focused review of methodological considerations for studies of feature-based attention using SSVEPs. In the review, we quantify potentially important stimulus parameters that have been used in the past (e.g., stimulation frequency, trial counts) and we discuss the potential importance of these and other task factors (e.g., feature-based priming) for SSVEP studies.

A Review of Methodological Considerations for Economic Evaluations of Gene Therapies and Their Application in Literature.

To identify methodological considerations discussed in literature addressing economic evaluations (EEs) of gene therapies (GTs). Additionally, we assessed if these considerations are applied in published GT EEs to increase understanding and explore impact. First a peer-reviewed literature review was performed to identify research addressing methodological considerations of GT EEs until August 2019. Identified considerations were grouped in themes using thematic content analysis. A second literature search was conducted in which we identified published evaluations. The EE quality of reporting was assessed using Consolidated Health Economic Evaluation Reporting Standards. The first literature search yielded 13 articles discussing methodological considerations. The second search provided 12 EEs. Considerations identified were payment models, definition of perspectives, addressing uncertainty, data extrapolation, discount rates, novel value elements, and use of indirect and surrogate endpoints. All EEs scored satisfactory to good according to Consolidated Health Economic Evaluation Reporting Standards. Regarding methodological application, we found 1 methodological element (payment models) was applied in 2 base cases. Scenarios explored alternative perspectives, survival assumptions, and extrapolation methods in 10 EEs. Although EE quality of reporting was considered good, their informativeness for health technology assessment and decision makers seemed limited owing to many uncertainties. We suggest accepted EE methods can broadly be applied to GTs, but few elements may need adjustment. Further research and multi-stakeholder consensus is needed to determine appropriateness and application of individual methodological considerations. For now, we recommend including scenario analyses to explore impact of methodological choices and (clinical) uncertainties. This study contributes to better understanding of perceived appropriate evaluation of GTs and informs best modeling practices.

Identifying People With Intellectual and Developmental Disabilities in National Population Surveys.

Public health and policy planning for adults with intellectual and developmental disabilities (IDD) is imperiled by the lack of ongoing national surveillance data on prevalence and health status. In 2018, the Administration on Intellectual and Developmental Disabilities appointed a workgroup of representatives from key federal agencies and national experts to recommend strategies to improve prevalence estimates and health surveillance for people with IDD. This article presents the workgroup findings on the availability of prevalence and health surveillance data for adults with IDD and suggested items that could identify respondents with IDD on national surveys with special attention to modifications in the National Health Interview Survey. We identify core constructs that must be measured to identify sample members with IDD in population surveys, and additional constructs which, if measured, would support more comprehensive identification of sample members and enhance ongoing surveillance of the health status, outcomes, and unmet needs of this population. We conclude with a brief review of methodological considerations to improve IDD national surveillance including cultural and linguistic sensitivity and the inclusion of U.S. territories in national surveillance protocols.

Primer in Genetics and Genomics, Article 2-Advancing Nursing Research With Genomic Approaches.

Nurses investigate reasons for variable patient symptoms and responses to treatments to inform how best to improve outcomes. Genomics has the potential to guide nursing research exploring contributions to individual variability. This article is meant to serve as an introduction to the novel methods available through genomics for addressing this critical issue and includes a review of methodological considerations for selected genomic approaches. This review presents essential concepts in genetics and genomics that will allow readers to identify upcoming trends in genomics nursing research and improve research practice. It introduces general principles of genomic research and provides an overview of the research process. It also highlights selected nursing studies that serve as clinical examples of the use of genomic technologies. Finally, the authors provide suggestions about how to apply genomic technology in nursing research along with directions for future research. Using genomic approaches in nursing research can advance the understanding of the complex pathophysiology of disease susceptibility and different patient responses to interventions. Nurses should be incorporating genomics into education, clinical practice, and research as the influence of genomics in health-care research and practice continues to grow. Nurses are also well placed to translate genomic discoveries into improved methods for patient assessment and intervention.

Internet ethnography: A review of methodological considerations for studying online illness blogs

BackgroundIn recent history, the Internet has emerged as a wealth of archived, ongoing, interactive, and socially mediated data. Conducting Internet ethnography is a fairly new methodological approach, however, it has been previously described as a valid form of inquiry. Illness blogs, in particular, have great implications for nurse researchers, as they are able to study the experience of illness in a naturalistic and longitudinal manner, often with greater detail than data relying solely on participant recall. Participants are able to produce online illness blogs as a way to share their own illness narratives and connect with others going through similar processes. ObjectivesThe purpose of this paper is to discuss methodological considerations in studying online illness blogs through Internet ethnography. MethodsThis article provides an overview of Internet ethnography as an emerging qualitative method and an introduction to research using illness blogs. Through use of this method in an exemplar study of young women with cancer, key decision points are highlighted along with the study team's field experiences. ConclusionIssues pertaining to method applicability, active vs. passive involvement as a researcher, ethical considerations, what constitutes data, sampling approach, procedural and analytic decisions, and thoughts regarding reflexivity and voice of the research participants’ are addressed. Strengths and limitations of the study of online illness blogs through Internet ethnography in nursing science are also discussed.

Secondary use of randomized controlled trials to evaluate drug safety: a review of methodological considerations

Randomized clinical trials (RCTs) are often positioned at the top of evidence hierarchies. Meta-analyses of RCTs aim to integrate the state of knowledge on a given scientific question, particularly for rare drug-related outcomes. However, although RCTs are valuable tools in our armamentarium, they are rarely designed to evaluate drug safety and are thus susceptible to limitations that may hamper the ability of both RCTs and meta-analyses to fully characterize the safety profiles of drugs. Their potential limitations might be exacerbated in the study of rare outcomes, often encountered in drug safety assessment, when even minor deviations from the intended randomization could impact the stability of the risk estimates. This article considers the methodological caveats of both RCTs and meta-analyses of RCTs pertinent to the study of drug-related harms. It is intended to stimulate discussion about the impact of these caveats on interpreting findings of RCTs and meta-analyses for drug safety, which would foster more robust, critical evaluations, and thus enhance clinical and regulatory decision-making. Pertinent issues that can influence the interpretation of drug-related harms discussed in this article were based on authors' expertise and review of the literature. Investigators and clinicians should be cognizant of the potential limitations of the secondary use of RCTs and meta-analyses in the assessment of drug-related harms and, when applicable, should consider potential remedies to overcome these limitations. Only few practical examples are included in the article due to the fact that many of the discussed caveats are not examined and/or reported in many publications. In addition, the confidential nature of data reviewed at a regulatory agency forestalls an in depth discussion of examples pertaining to specific drugs. Furthermore, our ability to quantify the extent of encountering, or the actual impact of, the caveats addressed in this review on the RCTs findings is limited. It is worth noting that the mere encounter of a given caveat does not mean that it will obviate the utility of drug safety information from a given trial. The extent of its impact is expected to vary based on the specifics of the trial, the drugs studied, the indications, and the nature of the adverse events. Although some of the limitations described are inherent in RCTs, some of the sources of bias highlighted in this article could be minimized by careful RCT design, planned follow-up, and improved collection of information on adverse events. As future research sheds more light on pertinent knowledge gaps and issues, the ability to maximize the use of RCTs and meta-analyses of RCTs to address drug safety questions of interest will be greatly enhanced.

The Cost of Cochlear Implantation: A Review of Methodological Considerations

Objectives. Cost studies can provide useful guidance, so long as they adhere to accepted methodology. Cochlear implants (CIs) are electronic devices introduced surgically into the inner ear. It is a relevant example to review cost study analyses because of its costliness. The aim of this study was to review relevant published cost studies of CI to analyze the method used. Methods. First, we described the key points of cost study methodology. Cost studies relating to CI were systematically reviewed, focussing on an analysis of the different methods used. Results. The methods, data sources, and estimated cost categories in each study varied widely. The paper showed that cost studies adopted significantly different approaches to estimate costs of CI, reflecting a lack of consensus on the methodology of cost studies. Conclusion. To increase its credibility, closer agreement among researchers on the methodological principles of cost studies would be desirable.

The Self-Concept: A Review of Methodological Considerations and Measuring Instruments, Vol 1.

The Self-Concept: A Review of Methodological Considerations and Measuring Instruments, Vol 1.