P57 Global recruitment for the RESECT study (transurethral REsection and Single-instillation intravesical chemotherapy Evaluation in bladder Cancer Treatment) - an international observational cohort study aiming to improve the quality of surgery for non-muscle invasive bladder cancer
Chon Meng LamKristalyn K. GallagherNikita BhattKieran ClementE. ZimmermannTaimur T. ShahSinan KhadhouriMeghana KulkarniChen GaoAlexander LightKeerthana JayaraajanAqua AsifT AnbarasanVinson Wai‐Shun ChanVeeru Kasivisvanathan
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Abstract Introduction Non-muscle invasive bladder cancer (NMIBC) is one of the most expensive cancers to treat, driven by high recurrence rates and disease progression. Mortality rates in the UK for all bladder cancers have remained relatively stable over the past decade. NMIBC can be curatively treated with transurethral resection of the bladder tumour (TURBT). Despite international evidence-based guidelines on the TURBT procedure and postoperative single instillation of mitomycin-C, TURBT quality continues to vary widely. RESECT will be the first ever international study of TURBT surgery evaluating the achievement of TURBT quality indicators globally and assessing if audit and performance feedback can improve surgical outcomes. Methods RESECT is a prospective, multicentre international observational cohort study. Collaborators at each site will collect data using REDCap about local TURBT practice, early recurrence rates and the experience of local TURBT surgeons. The primary outcome is the rate of achievement of key TURBT quality indicators. Advertisement for the study launched in 2020. Results As of October 1st, 2020, 524 collaborators have registered to participate. Collaborators represent 334 centres from 54 countries, with the highest number of centres from the United Kingdom (133), Spain (17), and India (16). 50.8% are trainees, 30.3% consultants, and 17.2% medical students. Based on current registrations, patient recruitment will far exceed initial projections and considerably improve statistical power. Conclusion RESECT has attracted many collaborators internationally from consultants and trainees at all stages. RESECT has significant potential to positively impact TURBT practice, health economics and ultimately improve outcomes for patients with NMIBC globally.Many questions in human health research can only be answered with observational studies. In contrast to controlled experiments or well-planned, experimental randomized clinical trials, observational studies are subject to a number of potential problems that may bias their results.Some of the more important problems affecting observational studies are described and illustrated by examples. Additional information is provided with reference to a selection of the literature.Factors that may bias the results of observational studies can be broadly categorized as: selection bias resulting from the way study subjects are recruited or from differing rates of study participation depending on the subjects' cultural background, age, or socioeconomic status, information bias, measurement error, confounders, and further factors.Observational studies make an important contribution to medical knowledge. The main methodological problems can be avoided by careful study planning. An understanding of the potential pitfalls is important in order to critically assess relevant publications.
Information bias
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72 preschoolers and 72 school children observed the original discrimination of nonreversal shift (NRS) followed by 14 NRS trials by themselves. The observational trials were 10 or 30 in each age group. The correct (_??_) or incorrect (×) responses on the 1st (unchanged pair) and the 2nd (changed pair) trials of NRS were mainly measured. In preschoolers, both dependent observational-learning mode (_??_-× responses: DOL) and independent observational-learning mode (_??_-_??_ and ×-×: IOL) were found, but no observational-trial effects on the modes were found. In school children, DOL occurred significantly more than IOL in both groups, and the observational-trial effect was also found. Subproblem analyses suggested that the _??_-× responses were indeed the “dependent” mode rather than the “independent” one.
Observational learning
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Background: Observational methodology is one of the most suitable research designs for evaluating fi delity of implementation, especially in complex interventions.However, the conduct and reporting of observational studies is hampered by the absence of specifi c guidelines, such as those that exist for other evaluation designs.This lack of specifi c guidance poses a threat to the quality and transparency of these studies and also constitutes a considerable publication hurdle.The aim of this study thus was to draw up a set of proposed guidelines for reporting evaluations based on observational methodology.Method: The guidelines were developed by triangulating three sources of information: observational studies performed in different fi elds by experts in observational methodology, reporting guidelines for general studies and studies with similar designs to observational studies, and proposals from experts in observational methodology at scientifi c meetings.Results: We produced a list of guidelines grouped into three domains: intervention and expected outcomes, methods, and results. Conclusions:The result is a useful, carefully crafted set of simple guidelines for conducting and reporting observational studies in the fi eld of program evaluation.
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Ethics committee
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The purposes of this study were to develop and implement an observational training program and to assess the effects of a video observational training program on video and live observational proficiency. Physical education majors took a pretest in both a video and a live environment to assess observational proficiency. The task was observing children batting and answering questions regarding the critical features of the movement. The students were then placed into either a treatment ( n = 12) or a control ( n = 11) group. There were no differences between groups on either assessment ( p > .05). The treatment group then participated in a video observational training program. After the training, all subjects took a posttest in each environment to assess observational proficiency. The training was found to be effective in improving video observational proficiency ( p < .05) but not live observational proficiency ( p > .05). These results provide support for the effectiveness of video observational training in developing video observational proficiency but not live observational proficiency.
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Observational methods such as OW AS. RULA. and REBA have been widely used to identify posture-related risks of musculoskeletal disorders in industry, since they are useful and efficient in evaluating postural stresses. However. there are few studies comparing the methods and providing guidelines for selecting and using the methods. They have been developed based on different backgrounds and with different application areas. Each method has its own characteristics. which must be considered in selecting and using them. In this study. 17 male subjects evaluated 42 different working postures that frequently assumed in the automobile assembly line using a psychophysical method. The postures were then evaluated by different observational methods. The results of the observational methods were compared with psychophysically evaluated stresses. The observational methods resulted in different values of stresses for certain postures. For some postures showing high values of perceived discomfort. the observational methods showed different values of stresses. These results showed that the observational methods should be used differently according to application area and they have some weak points to be improved.
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Studies can be observational or experimental. With an observational study, the investigator does not determine the assignment of subjects, and there might not be a control group. If there is a control group, assignment of the independent variable (exposure or intervention) is not under the control of the investigator. Observational studies can be rigorously conducted, but the lack of random assignment of the exposure/intervention introduces confounding and bias. Thus, the quality of evidence resulting from observational studies is lower than that of experimental randomized controlled trials (RCTs). An observational study might be performed if an RCT is unethical, impractical, or outside the control of the investigator. There are many types of prospective and retrospective observational study designs. However, an observational study design should be avoided if an experimental study is possible. Sophisticated statistical approaches can be used, but this does not elevate an observational study to the level of an RCT. Regardless of quality, an observational study cannot establish causality.
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The article describes the basic rules for conducting observational studies, in particular, registers. The principles of the assessment of its quality and impact on the results are discussed. The potential for evaluating therapeutic effect and side effects in randomized controlled trials (RCTs) and observational studies is compared. Effects of one drug identified in RCTs and observational studies are compared.
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