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Designing and Delivering a DTx Clinical Research Program: No Need to Re-invent the Wheel
Published in Oleksandr Sverdlov, Joris van Dam, Digital Therapeutics, 2023
Colin A. Espie, Alasdair L. Henry
A simplified version of the Oxford Centre for Evidence-Based Medicine (CEBM) hierarchy (Figure 4.2) serves to illustrate that contemporary methods for assessing the strength of evidence continue to prioritize the randomized controlled trial (RCT). The levels of evidence approach can be used as a heuristic “rule of thumb” that clinicians and patients can use to answer clinical questions and make clinical decisions quickly and without resorting to pre-appraised sources. While they are simple and easy to use, hierarchies that place randomized trials above observational studies have also been criticized for being too simplistic, and there is recognition that even case-series and single-case designs may provide more definitive evidence. Of course, rather than a single trial, a body of evidence provides more robust validation of a treatment's effectiveness. This is why the systematic review and meta-analysis (Schäfer and Schwarz, 2019) typically sit at the top of the evidence hierarchy.
Basic Research Design:
Published in Lynne M. Bianchi, Research during Medical Residency, 2022
Lynne M. Bianchi, Luke J. Rosielle, Justin Puller, Kristin Juhasz
Limitations: Case reports and case series provide information about a single patient or small group of patients and therefore have limited generalizability. Because observations from one or a few patients are not enough to sway clinical practice, these studies are ranked near the bottom of the evidence-based pyramid, a system for ranking the value of study designs in clinical decision making (Box 4.1). Furthermore, the quality of these studies is often inconsistent. Some authors view case reports as an “easy” publication and put little thought into the content, purpose, or value of adding the case to the medical literature.
Retinoblastoma
Published in Dongyou Liu, Handbook of Tumor Syndromes, 2020
Claire Hartnett, Mandeep S. Sagoo, M. Ashwin Reddy
The treatment of retinoblastoma is multidisciplinary and aims, in order of priorities, at saving life, saving the eye, and preserving vision. Just over 50 years ago the treatment for retinoblastoma involved removal of the eye (enucleation); the prognosis was poor and survival rates were low. Today, there is a wide range of treatments available and retinoblastoma has one of the best cure rates of all childhood cancers [4]. However, the evidence base for clinical management is comprised of case series and cohort studies. Rigorous controlled clinical trials in retinoblastoma are lacking for a number of reasons: complex presentations (two eyes with different disease severity), too few patients in countries where resources are available to conduct clinical trials, and a high societal value on eyes and vision that imposes considerations beyond curing the cancer. The goal of using multicenter, randomized, controlled clinical trials to optimize and standardize treatments is laudable, but in reality is difficult to attain.
E-cigarette or vaping-associated lung injury (EVALI): a review of international case reports from outside the United States of America
Published in Clinical Toxicology, 2023
Lachlan J. Sund, Paul I. Dargan, John R. H. Archer, David M. Wood
This research was subject to a number of limitations. Obviously, the non-US case numbers were small, thus preventing a more substantive statistical analysis. An element of underrecognition of EVALI by international physicians likely contributed to these low case numbers. In addition, the US case series were chosen on the basis of having the comparative characteristics of patient demographics, exposure, symptomatology, clinical course, and management, limiting the number of US cases included. It is possible that the 125 US cases included were not representative of the 2,807 EVALI cases reported to the CDC in regard to these comparative factors. It should also be noted that of the non-US cases, one case was from Canada (close proximity to the US), one was from Guam (a US territory), and the case from Spain was described as “imported” from the US, although the arrival date in Spain was not reported [23,26,30].
Hamstrings injury incidence, risk factors, and prevention in Rugby Union players: a systematic review
Published in The Physician and Sportsmedicine, 2023
Christian Chavarro-Nieto, Martyn Beaven, Nicholas Gill, Kim Hébert-Losier
The tool uses a ‘star system,’ wherein more stars indicate a superior methodological quality and lower risk of bias. The NOS awards a maximum of 10 stars: five stars for selection (representativeness of the sample, sample size, non-respondents, and ascertainment of the exposure), two stars for comparability, and three stars for outcome (assessment of outcome and statistical test). Reviewers agreed that for the statistical test item, the highest star rating would be allocated for the reporting of confidence intervals, quartiles, or limits of agreement. The methodological quality of studies was divided into three groups based on the number of stars awarded: weak (0 to 3 stars), moderate (4 to 6 stars), and strong (7 to 10 stars) [25]. The design of each study was classified as cohort studies, case series, cases and controls, or randomized controlled trial.
Systematic review – alopecia areata and tofacitinib in paediatric patients
Published in Cutaneous and Ocular Toxicology, 2022
António Bandeira, António Albino-Teixeira, Sofia Magina
The presented scientific background raises the question whether Tofacitinib can improve outcomes on AA in paediatric patients. Moreover, it is important to assess the therapeutic safety in paediatric patients. To address this clinical questions, we developed our literature search strategy based on the following PICOS strategy:Participants – All paediatric patients suffering from AA.Interventions – Treated with Tofacitinib, topically or systemically.Comparisons – Either with no treatment, standard glucocorticoid treatment or with any other treatment that the patient has tried.Outcomes – Effectiveness in reduce SALT Score and associated adverse effects.Study design – Case Reports, Case series or other types of descriptive studies (where we were able to individualise each patient).