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In this article, we’re going to cover:
- General Scientific Research Publication Format
- Types Of Research
- Gold Standard
- Literature, Systematic Reviews, Meta-Analysis
- P. Value, Publication, Bias, and Other Factors
From Part 1, we explored the difference between mainstream westernized medical views and indigenous/traditional viewpoints. In Part 2, we dive into the different types of scientific research that we have today.
4. GENERAL SCIENTIFIC RESEARCH PUBLICATION FORMAT
The majority of research papers follow a very general format for presenting their findings. Knowing what each of these sections contains can help us locate the most pertinent information and findings and make reading through them less daunting.
The abstract of each research paper is at the beginning. There is a short summary of the research that was conducted, the results, and the team's conclusion. It provides a clear understanding of which articles are relevant to our clients without having to read the whole article.
Introducing the research and situating it in context with what is already known, including information on traditional use and its goals. The authors might also describe the type of study they conducted.
Throughout this section, the research team will describe how it was conducted. It includes data on the subjects (age, sex, ethnicity, etc. ), any selection criteria, the type of research (see below for more information on the different types of research), the herb(s), constituent, form (capsule, alcohol or water extract, standardized or not, etc.), dose applied, and how the data was analyzed.
In this section, the study's data analysis results are presented. Typically, they are presented in a concise format without interpretation. Some may find this section intimidating as it contains a lot of statistics and charts that may seem confusing to the untrained eye. Do not spend too much time on this section if you aren't used to reading research papers. Let's jump ahead to the discussion and conclusions, where the authors explain their findings and their assessment. To verify their interpretations, the results section can be used as a reference point.
In this section, the authors explain their results in detail and provide additional information. It is common for them to present other similar research and discuss how it compares to theirs. Researchers should list the limitations of their research here, but not all do so, so be prepared to evaluate for yourself what the weak points are.
In general, this section summarizes the authors' conclusions from their research. Conclusions often repeat in a more concise way what was already discussed in the discussion section and suggest further research.
A Big But!
It is helpful to know what critical points to think when reading scientific research. These questions will also help you read research critically instead of simply taking it at face value. Research on herbs and traditional medicines often fails to take into account how they are used in practice without herbalists and other traditional medicine practitioners involved. Not only can this affect results and accuracy, but how relevant the research is to you and your client. Let's explore some key points.
1. The goal of ressearch
2. The context
3. How the study is designed
5. Preparation and methods/dosages used
6. Traditional or modern practice/method
7. The limitations of the research
8. Who funded the research and who makes up the research team
9. Is there a clinical application? If so, what?
5. TYPES OF RESEARCH
Each type of study has its own strengths and weaknesses when it comes to research. This section will run over the basics of all the unfamiliar terms. It might be more helpful to use it more as a reference. The more you read current research the more familiar you will be with the different types of studies and what to look out for.
Vivo vs. Vitro
No matter what the overarching study design, be sure to note whether a study is in vivo or in vitro.
The term in vitro (which means "in glass") refers to research conducted outside of the normal biological setting, such as in a petri dish or test tube. Tests are performed on isolated biological aspects, such as proteins or cells. The benefit of this kind of study is that it simplifies the testing environment from the hugely complex system that is the human body. This allows scientists to gain a deeper understanding of what is really going on in the body. These findings are often difficult to extrapolate back to the complete and complex biology of an individual.
Studies that take place in vivo (which means "in life/living" in Latin) are studies that are performed on whole, living organisms, including humans, animals, and plants. Animals or humans are often used in clinical trials in vivo. Studies in vivo can be expensive but are preferred to in vitro to gain an accurate understanding of how the focus of a study (substance, procedure, etc.) will perform in practice (Vignais & Vignais, 2010).
An observational study involves observing subjects without changing the study environment. Researchers observe effects rather than trying to control them with outside "treatment or intervention".
Observational research is the most basic type of study with limited input from the research team. The emphasis is placed on the collection of data and analysis.
There are also different types of observational studies:
- Case Control Study – a study where two groups are selected by outcome, and researchers look to correlate specific criteria with those outcomes. These types of studies require fewer resources but provide less concrete evidence. They are sometimes used as preliminary studies to find initial connections to provide a case for longer and more in-depth studies.
- Cross-Sectional Study – a descriptive study in which data is collected from a population at one specific point in time. This type of study allows researchers to look at several variables simultaneously.
- Longitudinal Study – a study where researchers conduct several observations on the same subjects over a long period of time, often years to decades. Researchers can use this to identify changes and developments over time at the individual and group level. A longitudinal study is more likely to point to cause and effect relationships than a cross-sectional study.
- Cohort Study – a type of longitudinal study that observes a population with a shared characteristic, such as a birth year, type of disease, specific behavior (coffee drinkers, for instance). We compare this group with a control population that does not share these characteristics. Many cohort studies last years rather than only weeks. Like cross-sectional studies, these also allow researchers to examine multiple variables at the same time, but they are often large and time-consuming, which makes them expensive.
Observational studies are easier to design and less costly. It is also the only ethical way to explore certain issues. As an example, you would not want to expose subjects to a potentially harmful situation or substance in a randomized controlled trial. However, the results can be easily challenged because they often do not consider all variables.
Unlike observational studies, experimental studies often introduce an intervention/treatment and study its effects. Experimentation falls into two categories:
- Randomized Controlled Study – in these studies subjects are assigned to two or more groups by chance. One group receives the intervention and the other group receives nothing or a placebo. Researchers study what occurs in each group and can draw conclusions based on the use of the “intervention.”
- Clinical Controlled Study – this is similar to the randomized controlled study, except that subjects are not randomly assigned to groups. This can introduce a significant bias that can influence results.
Participants in the control group either received nothing or a placebo that looked and tasted the same. Data would be collected and analyzed. Experimental studies differ from observational studies, where researchers simply observe those with existing experiences vs. those without, because they introduce certain subjects consumption to randomly selected participants and analyze the results.
The benefit of experimental studies is that they eliminate bias, especially if they are randomized, controlled, and double-blind.
It is most useful to understand the difference between observational and experimental studies, but you will also come across other terms when reviewing research. Here's a quick summary of what they mean (Kestenbaum, 2009):
- Descriptive study – any study conducted without changing the environment. These can be observational or correlational.
- Correlational study - any study that determines if two variables are correlated, in that as one variable increases or decreases it corresponds to an increase or decrease in the other variable. Researchers gather original data in a primary study. These can be descriptive or experimental.
- Secondary study – usually a summary or synthesis of existing research.
- Prospective study – a study that looks for outcomes, such as the development or alleviation of a disease or symptoms during the study period. These usually take place over a long period of time.
- Retrospective study – a study that looks backwards, often at exposure to risks or protection factors. These studies are more open to bias and errors.
6. GOLD STANDARD
The gold standard for all scientific research is a study that is randomized, controlled, and double-blind (also known as RCDB). Researchers believe that this study design will provide the most accurate information and will demonstrate an association with as little bias as possible. Research is conducted in RCDB, and subjects are randomly assigned to groups (treatments/interventions and placebos). In comparison with other randomized studies, a placebo group is always used. This allows researchers to isolate the true effectiveness of a treatment, such as an herb or herb formula, rather than what is due to the placebo effect, where an inert treatment still has effects based on the belief that it is working.
Additionally, RCDB studies are double-blind, which means neither the researchers nor the subjects know whether they are receiving the treatment or a placebo. Researchers are also subject to bias and may look for expected signs of effectiveness when they know who is receiving treatment.
RCDB studies may also be conducted in phases:
- Pilot trials: used to give researchers bare-bones data to investigate whether a full clinical trial is worth conducting.
- Phase I: usually consists of a small sample size of subjects with a short duration.
- Phase II: is more involved, with a larger sample size of subjects and often a longer duration. Occasionally different researchers conduct it in order to compare notes.
- Multi-centered trials: this provides another layer of depth of study between Phase II and a full clinical trial and occurs at several sites.
An RCDB study is considered the most optimal because it most clearly demonstrates a cause and effect relationship, but other studies can still provide valuable information. To get a bigger picture, we don't want to dismiss studies based solely on what type of study they are.
7. LITERATURE, SYSTEMIC REVIEWS, META-ANALYSIS
Literature reviews and meta-analyses are common secondary studies. These studies are often undertaken to gain an in-depth understanding of existing research and identify patterns and consensus.
An assessment of the existing literature on a topic is done by reviewing studies that have already been conducted. In addition, it identifies any research gaps. These studies are also often used to provide a case for further research, whether on an herb, a disease/condition, or even more broadly within a field of study.
A systematic review examines all high-quality evidence relevant to a particular research question (Cooper, 2009). For this reason, additional criteria are often set for selecting studies. Studies in systematic reviews are typically randomized, controlled, and double-blinded, but reviewers may set additional parameters. The goal of this type of review is to provide an extensive summary of all research relevant to the research question. They often, but not always, use some statistical analysis to assist in the assessment of the research to date.
Meta-Analyses are systematic reviews that use statistical analysis to compare and contrast the data from all the research included in the literature reviews. They are statistical snapshots of a systematic review. They help identify patterns, areas of disagreement, and other relevant relationships between the studies included.
8. P.VALUE, PUBLICATION, BIAS, OTHER FACTORS
Here comes the publication after all the studies, observations, testing, and reviews. Despite this, not all publications are straight forward and not all of them are done correctly. Here is an explanation from the science communicator, Derek Muller, of Veritasium.
We’ll continue in Part 3
Research & Resource :
- Herbal Academy Advanced Herbalism Unit 2
- Standford EDU