Wishful Extrapolation from Research to Patient Care

Author(s):  
Charles F. Manski

This chapter critiques how evidence from randomized trials has been used to inform medical decision making. Trials have long enjoyed a favored status within medical research on treatment response and are often called the “gold standard” for such research. The U.S. Food and Drug Administration (FDA) ordinarily considers only trial data when making decisions on drug approval. The well-known appeal of trials is that, given sufficient sample size and complete observation of outcomes, they deliver credible findings about treatment response within the study population. However, it is also well-known that extrapolation of findings from trials to clinical practice can be difficult. Researchers and guideline developers often use untenable assumptions to extrapolate. The chapter refers to this practice as wishful extrapolation. It discusses multiple reasons why extrapolation of research findings to clinical practice may be suspect.

2020 ◽  
Vol 29 (2) ◽  
pp. 688-704
Author(s):  
Katrina Fulcher-Rood ◽  
Anny Castilla-Earls ◽  
Jeff Higginbotham

Purpose The current investigation is a follow-up from a previous study examining child language diagnostic decision making in school-based speech-language pathologists (SLPs). The purpose of this study was to examine the SLPs' perspectives regarding the use of evidence-based practice (EBP) in their clinical work. Method Semistructured phone interviews were conducted with 25 school-based SLPs who previously participated in an earlier study by Fulcher-Rood et al. 2018). SLPs were asked questions regarding their definition of EBP, the value of research evidence, contexts in which they implement scientific literature in clinical practice, and the barriers to implementing EBP. Results SLPs' definitions of EBP differed from current definitions, in that SLPs only included the use of research findings. SLPs seem to discuss EBP as it relates to treatment and not assessment. Reported barriers to EBP implementation were insufficient time, limited funding, and restrictions from their employment setting. SLPs found it difficult to translate research findings to clinical practice. SLPs implemented external research evidence when they did not have enough clinical expertise regarding a specific client or when they needed scientific evidence to support a strategy they used. Conclusions SLPs appear to use EBP for specific reasons and not for every clinical decision they make. In addition, SLPs rely on EBP for treatment decisions and not for assessment decisions. Educational systems potentially present other challenges that need to be considered for EBP implementation. Considerations for implementation science and the research-to-practice gap are discussed.


2019 ◽  
Vol 10 (12) ◽  
pp. 1183-1199
Author(s):  
Mohammed Alrouili ◽  

This study attempted to identify the impact of internal work environment on the retention of healthcare providers at Turaif General Hospital in the Kingdom of Saudi Arabia. In particular, the study aimed to identify the dimensions of work circumstances, compensation, and relationship with colleagues, professional growth, and the level of healthcare providers’ retention. In order to achieve the study goals, the researcher used the descriptive analytical approach. The researcher used the questionnaire as the study tool. The study population comprised all the healthcare providers at Turaif General Hospital. Questionnaires were distributed to the entire study sample that consisted of 220 individuals. The number of questionnaires valid for study was 183 questionnaires. The research findings were as follows: the participants’ estimate of the work circumstances dimension was high (3.64), the participants’ estimate of the compensation dimension was moderate (3.32), the participants’ estimate of the relationship with colleagues dimension was high (3.62), the participants’ estimate of the professional growth dimension was weak (2.39), and the participants’ estimate of healthcare providers’ retention level was intermediate (2.75). Accordingly, the researcher’s major recommendations are: the need to create the right atmosphere for personnel in hospitals, the interest of the hospital to provide the appropriate conditions for the staff in terms of the physical and moral aspects for building the work adjustment in the staff, and conducting training courses and educational lectures for personnel in hospitals on how to cope with the work pressures.


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1464.2-1465
Author(s):  
S. Mendly ◽  
G. Boutsalis

Background:AAV (ANCA-associated vasculitis) is a group of progressive, rare, severe autoimmune diseases1,2. AAV can affect blood vessels in different parts of the body resulting in damage to vital organs such as the lungs, kidneys, nervous system, gastrointestinal system, skin, eyes, and heart.2 There are currently no approved therapies for remission-induction in patients with AAV. The current treatment armamentarium for AAV is comprised of various immunosuppressive therapies in combination with steroid treatment. Understanding clinical practice gaps in the management of AAV, can inform development of tools to improve physician practices.Objectives:This medical education activity aims to assess physicians’ knowledge on the various manifestations of antineutrophil cytoplasmic antibody-associated vasculitis (AAV), current guideline-recommended treatment strategies for remission induction in patients with AAV, as well as recent clinical trial data for combination therapies used for remission induction.Methods:A 24-question survey consisting of multiple-choice knowledge and case-based questions was made available to nephrologists and rheumatologists without monetary compensation or charge. The questions were designed to evaluate knowledge regarding the various manifestations of AAV and the results from clinical trials that have compared the efficacy of combination therapies used for remission induction in patients with AAV. As well as application of guideline-recommended therapies and clinical trial data for remission induction in patients with AAV within clinical practice. The survey launched online on a website dedicated to continuous professional development. (www.medscape.org/viewarticle/920320) on July 15, 2020. Data were collected until October 1, 2020.Results:363 nephrologists and 190 rheumatologists completed the survey. Physicians demonstrated gaps in the following areas:TopicIncorrect Responses to Knowledge and Clinical Decision-Making Questions (%)NephrologistsRheumatologistsSystemic diseases associated with AAV59%45%How to confirm diagnosis of AAV42%25%Therapy selection to induce remission that would be consistent with guidelines recommendations71%51%Guideline-recommended therapy for patients that do not respond to the induction regimen32%34%Definition of refractory disease95%94%Most effective maintenance strategy for a patient once remission is achieved80%64%Where would an emerging therapy such as a C5a receptor inhibitor fit into the therapeutic armamentarium of AAV?62%47%What are the guideline-recommended therapies to reduce remission in patients without organ-threatening disease?71%51%Most effective maintenance strategy for a patient once remission is achieved80%64%Guideline-recommendations on length of time to continue maintenance therapy31%35%Conclusion:This educational research on assessment of physicians’ (nephrologists and rheumatologists) clinical practices yielded important insights into clinical gaps related to understanding of the disease pathophysiology and progression of AAV, guideline recommendations on diagnosing and managing AAV with guideline-directed medical therapies (GDMTs), strategies for the management of relapsing and refractory disease in AAV and positioning of emerging therapies in the treatment paradigm.References:[1]www.medscape.org/viewarticle/920320.[2]Hutton HL, et al. Semin Nephrol 2017;37(5):418–35.[3]Al-Hussain T, et al. Adv Anat Pathol 2017;24(4):226–34.Disclosure of Interests:Sarah Mendly Grant/research support from: Supported by an independent educational grant from Vifor Pharma, George Boutsalis Grant/research support from: Supported by an independent educational grant from Vifor Pharma


2021 ◽  
Vol 21 (S1) ◽  
Author(s):  
Dávid Paár ◽  
Antal Kovács ◽  
Miklós Stocker ◽  
Márk Hoffbauer ◽  
Attila Fazekas ◽  
...  

Abstract Background The so-called sports consumption models are looking for the factors that influence the sports spending of households. This paper aims to examine the Hungarian, Polish and German households’ sports expenditures which can be an important indicator of physical activity and sporty lifestyle. Methods Surveying of households in three countries (Hungary, Poland and Germany) has been conducted with a self-designed questionnaire. We have used descriptive and bivariate non-parametric and parametric statistical methods: (1) χ2 test, Mann-Whitney test and Kruskal-Wallis test for checking the relationship between sociodemographic and physical activity variables and (2) independent sample t-test and ANOVA for checking the differences in sports expenditures. Results Our research concluded that men, especially previous athletes, exercise more than women and those who have no history as registered athletes. The choice of sports venues is obviously different between the countries in the sample. Members of the study population spend the most on sports services while they spend the least on sports equipment. German households have the highest spending rates compared to the other two countries. Conclusions Results are in line with our previous research findings and with other literatures. The difference in preferences of sports venues could have the reason of different supply of sports clubs or the different living standards too. It needs further researches to clear it. Material wealth, income level and sport socialisation can be a determining factor regarding the level of sports spending.


2021 ◽  
Vol 23 (1) ◽  
Author(s):  
Lucie Nekvindová ◽  
Jiří Vencovský ◽  
Karel Pavelka ◽  
Pavel Horák ◽  
Zlatuše Křístková ◽  
...  

Abstract Background Treat-to-target (T2T) is a widely accepted strategy for patients with rheumatoid arthritis (RA). It recommends attaining a goal of at least low disease activity (LDA) within 6 months; otherwise, the current therapy should be modified. We aimed to investigate whether switching a first-line targeted therapy (TT) in patients not reaching LDA within 6 months leads to a higher probability of meeting LDA at the 12-month visit in daily clinical practice using data from Czech registry ATTRA. Methods We included patients with RA starting the first-line TT from 1 January 2012 to 31 January 2017 with at least 1-year follow-up. We created four mutually exclusive cohorts based on (1) switching to another TT within the first year and (2) reaching a treatment target (DAS28-ESR ≤ 3.2) at the 6-month visit. The primary outcome was the comparison of odds for reaching remission (REM) or LDA at the 12-month visit between patients switching and not switching TT after not reaching treatment target at 6 months. Before using logistic regression to estimate the odds ratio, we employed the propensity score to match patients at the 6-month visit. Results A total of 1275 patients were eligible for the analysis. Sixty-two patients switched within the first 5 months of the treatment before evaluating treatment response at the 6-month visit (C1); 598 patients reached the treatment target within 6 months of therapy (C2); 124 patients did not reach treatment response at 6-month visit and switched to another therapy (C3), and 491 patients continued with the same treatment despite not reaching LDA at the 6-month visit (C4). We matched 75 patients from cohort C3 and 75 patients from C4 using the propensity score. Patients following the T2T principle (C3) showed 2.8 (95% CI 1.4–5.8; p = 0.005) times increased likelihood of achieving REM/LDA at the 12-month visit compared to patients not following the T2T strategy (C4). Conclusions In daily clinical practice, the application of the T2T strategy is underused. Switching TT after not reaching REM/LDA within the first 6 months leads to a higher probability of achieving REM/LDA in RA patients at the 12-month visit.


1997 ◽  
Vol 111 (7) ◽  
pp. 611-613 ◽  
Author(s):  
K. W. Ah-See ◽  
N. C. Molony ◽  
A. G. D. Maran

AbstractThere is a growth in the demand for clinical practice to be evidence based. Recent years have seen a rise in the number of randomized controlled clinical trials (RCTS). Such trials while acknowledged as the gold standard for evidence can be difficult to perform in surgical specialities. We have recently identified a low proportion of RCTS in the otolaryngology literature. Our aim was to identify any trend in the number of published RCTS within the ENT literature over a 30-year period and to identify which areas of our speciality lend themselves to this form of study design. A Medline search of 10 prominent journals published between 1966 and 1995 was performed. Two hundred and ninety-six RCTS were identified. Only five were published before 1980. Two hundred (71 per cent) of RCTS were in the areas of otology and rhinology. An encouraging trend is seen in RCTS within ENT literature.


Contexts ◽  
2021 ◽  
Vol 20 (3) ◽  
pp. 57-59
Author(s):  
Ashley C. Rondini

This article highlights that the standardization of medical care in the U.S. relies on clinical practice guidelines (CPGs), which indicate institutionalized norms about when and under what circumstances it is appropriate to administer specific medical tests and courses of treatment. However, when CPGs in medicine derive from medical research that was informed by since-debunked ideas about race, they may also facilitate structural racism.


2011 ◽  
Vol 11 ◽  
pp. 454-457 ◽  
Author(s):  
Tamas Bartfai ◽  
Graham Vaughan Lees

Within days of each other, Pfizer, Merck, and GlaxoSmithKline announced that they will focus on a few therapeutic areas only and abandon others entirely. Pfizer alone will close well over a hundred drug development projects that have reached two-thirds of the way to launch. The programs are deemed to be too risky and not lucrative enough for Big Pharma in the current climate. Society has a real need for the drugs that are no longer going to be developed for, among others, drug-resistant epilepsy, neuropathic and cancer pain, type-2 diabetes, obesity, and schizophrenia. The authors propose a radical response by the U.S. government and the National Institutes of Health to rescue these abandoned projects, and to continue selected programs for drug approval by the U.S. Food and Drug Administration and the European Medicines Agency. The investment required is small compared to the Troubled Asset Relief Program bank bail out, but the return on investment in financial terms and in satisfying societal needs makes this proposal attractive.


2019 ◽  
Author(s):  
Renaud Hage ◽  
Christine Detrembleur ◽  
Frédéric Dierick ◽  
Laurent Pitance ◽  
Laurent Jojczyk ◽  
...  

Various noninvasive measurement devices can be used to assess cervical motion. Size, complexity and cost of gold-standard systems make them not suited in clinical practice, and actually difficult to use outside dedicated laboratory. Nowadays, ultra-low-cost inertial measurement units are available but without any packaging nor user-friendly interface. DYSKIMOT is a home- designed, small-sized, motion sensor based on the latter technology, aiming at being used by clinicians in “real-life situations”. In the present study. DYSKIMOT was compared with a gold- standard optoelectronic system (Elite). Our goal was to evaluate the accuracy of DYSKIMOT in assessing the kinematics in fast head rotations. Kinematics was simultaneously recorded by the DYSKIMOT and Elite systems during the execution of the DidRen Laser test and performed by 15 participants and 9 patients. Kinematic variables were computed from the position, speed and acceleration time series. Two-way ANOVA, Passing-Bablok regressions and Dynamic Time Warping analysis showed good to excellent agreement between Elite and DYSKIMOT, both at the qualitative level of the time series shape and at the quantitative level of peculiar kinematical events’ measured values. In conclusion, DYSKIMOT sensor is as relevant as a gold-standard system to assess kinematical features during fast head rotations in participants and patients, demonstrating its usefulness in clinical practice or research in ecological environment.


10.32698/0992 ◽  
2020 ◽  
Vol 3 (1) ◽  
pp. 75
Author(s):  
Muhammad Riswan Rais ◽  
Marjohan Marjohan

This research is motivated by the low ability of the students of MAN 1 Mandailing Natal in communicating well interpersonal. Self-confidence and peer conformity are factors that are thought to affect interpersonal communication. This study aims to describe: (1) self-confidence, peer conformity, and interpersonal communication, (2) the contribution of self-confidence to interpersonal communication, (3) the contribution of peer conformity to interpersonal communication, (4) the contribution of confidence and peer conformity. peers together on interpersonal communication. This research uses a descriptive correlational quantitative method. The study population was all students of MAN 1 Mandailing Natal, amounting to 1130 people, a sample of 295 people, who were selected by proportional random sampling technique. The instrument used was a Likert scale model. The data were analyzed using descriptive statistics, simple regression, and multiple regression. The research findings show that: (1) on average, students 'self-confidence is in the high category, (2) peer conformity is in the high category, (3) students' interpersonal communication is in the good category, (4) self-confidence contributes 47.8 % towards interpersonal communication, (5) peer conformity contributes to interpersonal communication by 19.2%, and (6) peer confidence and conformity together contribute to interpersonal communication by 49.5%


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