scholarly journals History of controlled trials in medicine: real priorities are little-known. Report 2. From early experiments to the present day: without alternation and randomization

2021 ◽  
Vol 14 (3) ◽  
pp. 423-444
Author(s):  
A. N. Koterov ◽  
O. A. Tikhonova ◽  
L. N. Ushenkova ◽  
A. P. Biryukov
Keyword(s):  
Controlled Trial ◽  
The United States ◽  
Controlled Trials ◽  
Social Significance ◽  
Randomized Controlled ◽  
The United Kingdom ◽  
Health Related ◽  
Pubmed Search ◽  
History Of ◽  
The Uk

The aim of the three-report review is the historical development of clinical trials, controlled trials (CT) and randomized controlled trials (RCT), and the inclusion of these approaches in health-related disciplines (Medicine and Epidemiology). Report 2 provides a description of the wellknown James Lind Library (JLL), as well as a formed database of sources on the theme. JLL was internationalized, although most of the papers belong to authors from the UK. Many studies on the history of CT and RCT are reflected in JLL publications, but remain unclaimed without changing on common milestones and priorities. Besides, the formed base of sources included 9 studies not reflected in the JLL, of which three are principled. Six of them are given in Report 2.Half of historical milestones on the theme (168 in total) belong to the United Kingdom, 23% to the United States, and 4% to the Italy. The remaining 19 countries, ancient, medieval and modern, contribute 0.6–4% (Russia – 1.2% by the 20th century). The earliest source on the history of CT is J.P. Bull’s dissertation (1951). The formed database as of July 2020 contained more than 260 publications, and only 9 of them were Russian (2005–2018). The base includes 7 western dissertations on the history of CT.The object of the Report 2 study was CT as such, without any attempts at randomization or even quasi-randomization by alternate allocation. The most comprehensive thematic table on non-randomized CTs has been compiled, including studies from the Chinese emperor Shen Nung (2373 BC) and the prophet Daniel (6th century BC), to BCG vaccination for children of Canadian Indians (1941–1949). PubMed search on ‘non-randomized controlled trial’ was made. For the period of 1990–2020 years, 303 publications were found (up to 32 papers in 2020). Compared to RCT, the number of such studies is small (estimated at 0.08%), but it is important to have an appropriate conjuncture in the modern period. Along with the fact that most of the drugs and therapies currently in use are developed without RCT, the revealed ‘immortality’ of CT, even without quasi-randomization, can have social significance, removing complexes and embarrassment in cases where neither RCT nor even quasi-RCT is possible, but social and public needs require the immediate receipt of at least an approximate answer to hot questions of public health (for example, in 2020).

Limitations of Nonscience in Surgical Epistemology: The Second-Look Laparotomy

1989 ◽  
Vol 5 (3) ◽  
pp. 381-388 ◽  
Author(s):  
Michael Baum
Keyword(s):  
United Kingdom ◽  
Randomized Controlled Trials ◽  
Controlled Trial ◽  
The United States ◽  
Point Of View ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
The United Kingdom ◽  
Second Look ◽  
Complex Process

Decision-making in medicine is a very complex process that demands input both from the doctor and from the client. From the doctor's point of view, the most important component for this decision concerns the quality of evidence available that the recommended intervention is the best available in terms of both cost and benefit. Good quality evidence demands good quality science. The randomized controlled trial is the expression of this scientific process at work within medical practice. This article reviews both the rationale and the ethics of randomized controlled trials in the epistemology of surgery. The ethical dilemma is accentuated because surgery by its very nature is invasive and often irreversible. As an illustration of the scientific and ethical dilemmas arising out of randomized controlled trials in surgery, a description of the CEA directed second-look laparotomy trial in the United Kingdom is provided. This trial may be judged essential because of the clash of attitudes between surgeons in the United States and the United Kingdom. It is unlikely that the truth lies entirely with one or other national groupings of surgeons, and this randomized trial will eventually resolve a conflict of ideas to the ultimate benefit of all patients with operable colorectal cancer.

scholarly journals Effects of Side-Effect Risk Framing Strategies on COVID-19 Vaccine Intentions in the United States and the United Kingdom: A Randomized Controlled Trial

2021 ◽  
Author(s):  
Nikkil Sudharsanan ◽  
Caterina Favaretti ◽  
Violetta Hachaturyan ◽  
Till Baernighausen ◽  
Alain Vandormael
Keyword(s):  
United States ◽  
Randomized Controlled Trial ◽  
Side Effect ◽  
Motor Vehicle ◽  
Controlled Trial ◽  
The United States ◽  
Randomized Controlled ◽  
The United Kingdom ◽  
Percentage Points ◽  
Framing Strategies

Vaccination rates have stagnated in the United States and the United Kingdom leading to the continuing spread of COVID-19. Fear and concern over vaccine side-effects is one of the main drivers of hesitancy. Drawing from behavioral science and health communication theory, we conducted a randomized controlled trial among 8998 adults to determine whether the way COVID-19 vaccine side-effects are framed and presented to individuals can influence their willingness to take a vaccine. We presented participants information on a hypothetical future COVID-19 vaccine -- including information on its side-effect rate -- and then examined the effect of three side-effect framing strategies on individuals stated willingness to take this vaccine: adding a qualitative risk label next to the numerical risk, adding comparison risks, and for those presented with comparisons, framing the comparison in relative rather than absolute terms. Based on a pre-registered and published analysis plan, we found that adding a simple descriptive risk label (very low risk) next to the numerical side-effect increased participants' willingness to take the COVID-19 vaccine by 3.0 percentage points (p = 0.003). Providing a comparison to motor vehicle mortality increased COVID-19 vaccine willingness by 2.4 percentage points (p = 0.051). These effects were independent and additive: participants that received both a qualitative risk label and comparison to motor-vehicle mortality were 6.1 percentage points (p < 0.001) more likely to report willingness to take a vaccine compared to those who did not receive a label or comparison. Taken together, our results reveal that despite increasingly strong vaccination hesitancy and exposure to large amounts of vaccine misinformation, low-cost side-effect framing strategies can meaningfully affect vaccination intentions at a population level.

scholarly journals The randomised controlled trial in medical research: using bibliometric methods to identify core journals

2006 ◽  
Vol 1 (1) ◽  
pp. 104
Author(s):  
John Loy
Keyword(s):  
Growth Rate ◽  
Drug Therapy ◽  
Randomized Controlled Trials ◽  
Detailed Analysis ◽  
Medical Literature ◽  
Controlled Trial ◽  
The United States ◽  
Growth Patterns ◽  
Controlled Trials ◽  
Randomized Controlled

A review of: Tsay, Migh-yueh, and Yen-hsu Yang. “Bibliometric Analysis of the Literature of Randomized Controlled Trials.” Journal of the Medical Library Association 93.4 (October 2005): 450-58. Objective – To explore the characteristics and distribution of randomized controlled trials (RCTs) in the medical literature. The study aims to identify the growth patterns of the RCT, key subject matter, country and language of publication, and determine a list of core journals which contain a substantial proportion of the RCT literature. Design – Retrospective analysis of RCTs. Setting – Medical journal literature. Subjects – A total of 160,213 articles published between 1965-2001. Detailed analysis of a subset numbering 114,850 articles published from 1990-2001. Methods – The study seeks to identify all RCTs in MEDLINE from 1965-2001, and examines the growth rate of the RCT. The authors then do a more detailed analysis on a subset of data from 1990-2001, using Access database and Excel spreadsheet software, and PERL programming language. The references were analyzed by five fields within MEDLINE; publication type, source, language, country of publication, and descriptor (subject index). Main results – An exponential growth rate for the RCT is demonstrated, suggesting that in the medical literature development has not yet matured and that research using this method continues to grow. A growth rate for the RCT of 11.2% per annum is identified. The most common form of publication is the journal article, making up approximately 98% of the RCT literature. Approximately 75% of the RCTs are multicentre trials indicating that this is the design of choice adopted by researchers. The United States proves to be the greatest source of RCT literature, with 39.9% of journals and 50.6% of articles originating there. After the USA, the most productive countries are England (15.8% of journals and 21.7% articles) and Germany (6.5% journals and 6.1% articles). As might be expected, English is the predominant language providing 92.9% of the total publications. Of the remaining 7%, German is the most common language accounting for 2.2%. The top three areas being researched are: 1. Drug therapy for hypertension - 2291 citations 2. Anticancer drug combinations - 2140 citations 3. Drug therapy and asthma - 1397 citations Bradford’s law of scattering is successfully applied, identifying four zones of journals which each publish approximately 26,000 articles. Conclusion – The results indicate that bibliometric methods can be applied to the medical literature, and highlight those disciplines in which RCTs more often occur. A core list of 42 journal titles is presented, providing busy practitioners with invaluable guidance as to which journals are most likely to publish the greater number of RCTs.

scholarly journals A Crossover Randomized Controlled Trial of Priming Interventions to Increase Hand Hygiene at Ward Entrances

2022 ◽  
Vol 9 ◽  
Author(s):  
Kelly Ann Schmidtke ◽  
Navneet Aujla ◽  
Tom Marshall ◽  
Abid Hussain ◽  
Gerard P. Hodgkinson ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Hand Hygiene ◽  
Hand Hygiene Compliance ◽  
Controlled Trial ◽  
The United States ◽  
Future Research ◽  
Randomized Controlled ◽  
The United Kingdom ◽  
Visual Priming ◽  
Hygiene Compliance

BackgroundResearch conducted in the United States suggests that two primes (citrus smells and pictures of a person's eyes) can increase hand gel dispenser use on the day they are introduced in hospital. The current study, conducted at a hospital in the United Kingdom, evaluated the effectiveness of these primes, both in isolation and in combination, at the entry way to four separate wards, over a longer duration than the previous work.MethodsA crossover randomized controlled trial was conducted. Four wards were allocated for 6 weeks of observation to each of four conditions, including “control,” “olfactory,” “visual,” or “both” (i.e., “olfactory” and “visual” combined). It was hypothesized that hand hygiene compliance would be greater in all priming conditions relative to the control condition. The primary outcome was whether people used the gel dispenser when they entered the wards. After the trial, a follow up survey of staff at the same hospital assessed the barriers to, and facilitators of, hand hygiene compliance. The trial data were analyzed using regression techniques and the survey data were analyzed using descriptive statistics.ResultsThe total number of individuals observed in the trial was 9,811 (female = 61%), with similar numbers across conditions, including “control” N = 2,582, “olfactory” N = 2,700, “visual” N = 2,488, and “both” N = 2,141. None of the priming conditions consistently increased hand hygiene. The lowest percentage compliance was observed in the “both” condition (7.8%), and the highest was observed in the “visual” condition (12.7%). The survey was completed by 97 staff (female = 81%). “Environmental resources” and “social influences” were the greatest barriers to staff cleaning their hands.ConclusionsTaken together, the current findings suggest that the olfactory and visual priming interventions investigated do not influence hand hygiene consistently. To increase the likelihood of such interventions succeeding, future research should focus on prospectively determined mechanisms of action.

Science, Politics, and the Pandemic

2020 ◽  
Vol 119 (820) ◽  
pp. 303-309
Author(s):  
J. Nicholas Ziegler
Keyword(s):  
United States ◽  
Biomedical Research ◽  
Scale Up ◽  
Political Leadership ◽  
The United States ◽  
Scientific Advice ◽  
The United Kingdom ◽  
Effective Policy ◽  
Scientific Expertise ◽  
The Uk

Comparing the virus responses in Germany, the United Kingdom, and the United States shows that in order for scientific expertise to result in effective policy, rational political leadership is required. Each of these three countries is known for advanced biomedical research, yet their experiences in the COVID-19 pandemic diverged widely. Germany’s political leadership carefully followed scientific advice and organized public–private partnerships to scale up testing, resulting in relatively low infection levels. The UK and US political responses were far more erratic and less informed by scientific advice—and proved much less effective.

Sign in / Sign up

Export Citation Format

Share Document