What is research?
Alison Pooler in An Introduction to Evidence-based Practice in Nursing & Healthcare, 2014
Randomised controlled trials: these are a form of clinical trial and are used to determine the effectiveness of a treatment/ medicine or intervention; for example, if a certain drug has a positive effect on a certain disease process or if attending a specific clinic has an effect on the wellbeing of that patient. Randomised controlled trials are considered to be the highest quality in terms of producing valid results and often termed the ‘gold standard’. The methods used are very strict and stringent, such as participants being randomly allocated to treatment groups (called randomisation) and the use of placebos. Sometimes not even the researcher has any control over which participant goes into which group or, in the case of a drug trial, who will have the placebos. This is called blinding. Obviously, there are a lot of ethical considerations in randomised controlled trials, especially with the use of placebos. It is only ethical if, by not treating a group, they will not come to any harm. Informed consent also needs to be received from any participant involved in a clinical trial.
Quantitative approaches in sport-related concussion research
Gordon A. Bloom, Jeffrey G. Caron in Psychological Aspects of Sport-Related Concussions, 2019
Randomized controlled trials are preferred because, through randomization, they minimize the risk that confounding variables impact the conclusions of the study. The use of a control condition ensures that variations due to extraneous factors are accounted for within the study design. The prospective design also minimizes recall error and selection bias for participants, thus improving the fidelity of the results. Finally, the best advantage is that the study design allows for causal inferences. For instance, Swartz and colleagues (2015) conducted a randomized controlled trial in a concussion prevention setting to test a helmetless-tackling behavior intervention for collegiate football players. A sample of 50 players were randomized to either the intervention (25 players) or control (25 players) group. The intervention group participated in a five-minute tackling drill without their helmets or shoulder pads twice a week during the preseason and once per week throughout the season. During the same period, the control group performed noncontact football skills. Their frequency of head impacts was recorded with an impact sensor in all games. Differences between the two groups were examined, and the results supported that a helmetless-tackling training intervention reduced head impacts in collegiate football players within one football season.
Epidemiology and its uses
Liam J. Donaldson, Paul D. Rutter in Donaldsons' Essential Public Health, 2017
In order to justify carrying out a randomized controlled trial, which is both time-consuming and expensive, it is necessary to establish that it will answer a useful and valid question and that it is ethical. There are many dimensions to this, but a starting point is that there must be genuine equipoise, a real uncertainty about the effectiveness of an intervention that justifies exposing people to it or depriving them of it. In the conduct of a study involving human populations, a strict ethical code must be obeyed. A number of organizations have laid down codes of practice or guidelines for the conduct of research investigations involving people. Of particular importance are those that have been produced by the Helsinki Declaration (1964), the World Health Organization and the Royal College of Physicians of London.
Fibromyalgia and Nutrition: An Updated Review
Published in Journal of the American College of Nutrition, 2021
Laura Tomaino, Lluís Serra-Majem, Stefania Martini, Maria Rosaria Ingenito, Paola Rossi, Carlo La Vecchia, Fabrizia Bamonti, Luisella Vigna
However, little evidence suggests that nutrition and/or nutritional intervention play a significant role on FM severity or that these measures can exert a beneficial effect in ameliorating patients’ symptoms. Randomized controlled trials provide the best evidence of the efficacy of a treatment. Nevertheless, in the present review, the RCTs performed are weak, as the risk of bias is elevated. In fact, each trial investigated the effects of different interventions on FM symptoms (i.e. probiotic treatment (32), physiotherapy combined with lacto-vegetarian diet (34), antioxidant supplementation (38), gluten-free diet (40), or other nutritional supplementation (42)). There were also between-studies differences in the outcomes evaluated (i.e. cognition, emotional symptoms and functional status (32), low-back pain relief and body composition (34), FM symptoms (38), gluten-sensitivity symptoms (40), or physical fitness (42)).
Lack of Efficacy of the Neutropenic Diet in Decreasing Infections among Cancer Patients: A Systematic Review
Published in Nutrition and Cancer, 2020
Venkataraghavan Ramamoorthy, Muni Rubens, Sandeep Appunni, Anshul Saxena, Peter McGranaghan, Emir Veledar, Ana Viamonte-Ros, Nancy Shehadeh, Adeel Kaiser, Rupesh Kotecha
Studies that had outcome variable such as infection rates (e.g., bacteremia, pneumonia, or fungemia), infection-related mortality and mortality of any cause were included for the review. Two major types of studies that looked for the effectiveness of the neutropenic diet with above mentioned outcomes included: 1) meta-analyses (n = 3) which rigorously verify and ascertain the quality and methodology of individual studies; and 2) individual quantitative studies including randomized controlled trials (n = 5) and cohort studies (n = 3), such as prospective and retrospective studies. Randomized controlled trials generate superior evidences of efficacy, whereas observational studies need further investigation because they are correlational and do not establish the causal relationship. We have summarized the study characteristics such as source, year, design, settings, outcomes, results, and study rating following the directions by the Oxford Center for Evidence Based Medicine (22) in Table 1. Heterogeneity of study methods (meta-analysis, randomized controlled trials, and observational studies) and populations (adult and pediatric cancer patients) and differences in definitions of the neutropenic diet limited us from conducting a meta-analysis to calculate pooled estimates. Hence, we conducted a systematic review of different studies on the neutropenic diet.
Catatonia revived: a unique syndrome updated
Published in International Review of Psychiatry, 2020
Charles Mormando, Andrew Francis
Convulsive therapy has a historical tradition and modern support as a treatment for catatonia. In the 1930s, the use of both chemically induced and electroconvulsive seizures was described. Since then, clinical experience and case series have shown that ECT produces remission of catatonia even when other treatments (e.g. amobarbital or lorazepam) have failed (Bush et al., 1996b; Petrides et al., 2004). ECT can be considered first-line treatment in clinically severe and/or life-threatening cases (profound stupor or excitability leading to dehydration and exhaustion, autonomic instability, fever, etc.) However, a recent meta-analysis (Leroy et al., 2018) failed to demonstrate the usual statistical criteria for efficacy or effectiveness of ECT in the treatment of catatonia. This bespeaks to the difficulty in constructing quality randomized controlled trials rather than a true lack of effectiveness. An additional advantage of ECT is benefit for the associated affective or psychotic disorder. Clinical case reports suggest that ECT and lorazepam may be synergistic (Petrides, Divadeenam, Bush, & Francis, 1997).
Related Knowledge Centers
- Clinical Research
- Clinical Trial
- Selection Bias
- Experiment
- Medical Device
- Random Assignment
- Confounding
- Placebo
- Blinded Experiment
- Observer-Expectancy Effect