-Is the target population narrow or broad?
-Is the target population vulnerable?
-What are the eligibility criteria?
-What is the most appropriate recruitment strategy?
Occasionally, the intended population of the study needs to be modified, in order to overcome any potential ethical issues, and/or for the sake of convenience and feasibility of the project. Yet, the researcher must be aware that the external validity of the results may be compromised. As an illustration, in a randomised clinical trial, authors compared the ease of tracheal tube insertion between C-MAC video laryngoscope and direct laryngoscopy, in patients presenting to the emergency department with an indication of rapid sequence intubation. However, owing to the existence of ethical concerns, a substantial amount of patients requiring emergency tracheal intubation, including patients with major maxillofacial trauma and ongoing cardiopulmonary resuscitation, had to be excluded from the trial.[ 14 ] In fact, the design of prospective studies to explore this subset of patients can be challenging, not only because of ethical considerations, but because of the low incidence of these cases. In another study, Metterlein et al . compared the glottis visualisation among five different supraglottic airway devices, using fibreroptic-guided tracheal intubation in an adult population. Despite that the study was aimed to explore the ease of intubation in patients with anticipated difficult airway (thus requiring fibreoptic tracheal intubation), authors decided to enrol patients undergoing elective laser treatment for genital condylomas, as a strategy to hasten the recruitment process and optimise resources.[ 15 ]
Anaesthetic interventions can be classified into pharmacological (experimental treatment) and nonpharmacological. Among nonpharmacological interventions, the most common include anaesthetic techniques, monitoring instruments and airway devices. For example, it would be appropriate to examine the ease of insertion of Supreme™ LMA, when compared with ProSeal™ LMA. Notwithstanding, a common mistake is the tendency to be focused on the data aimed to be collected (the “stated” objective), rather than the question that needs to be answered (the “latent” objective).[ 1 , 4 ] In one clinical trial, authors stated: “we compared the Supreme™ and ProSeal™ LMAs in infants by measuring their performance characteristics, including insertion features, ventilation parameters, induced changes in haemodynamics, and rates of postoperative complications”.[ 10 ] Here, the research question has been centered on the measurements (insertion characteristics, haemodynamic variables, LMA insertion characteristics, ventilation parameters) rather than the clinical problem that needs to be addressed (is Supreme™ LMA easier to insert than ProSeal™ LMA?).
Comparators in clinical research can also be pharmacological (e.g., gold standard or placebo) or nonpharmacological. Typically, not more than two comparator groups are included in a clinical trial. Multiple comparisons should be generally avoided, unless there is enough statistical power to address the end points of interest, and statistical analyses have been adjusted for multiple testing. For instance, in the aforementioned study of Metterlein et al .,[ 15 ] authors compared five supraglottic airway devices by recruiting only 10--12 participants per group. In spite of the authors' recommendation of using two supraglottic devices based on the results of the study, there was no mention of statistical adjustments for multiple comparisons, and given the small sample size, larger clinical trials will undoubtedly be needed to confirm or refute these findings.[ 15 ]
A clear formulation of the primary outcome results of vital importance in clinical research, as the primary statistical analyses, including the sample size calculation (and therefore, the estimation of the effect size and statistical power), will be derived from the main outcome of interest. While it is clear that using more than one primary outcome would not be appropriate, it would be equally inadequate to include multiple point measurements of the same variable as the primary outcome (e.g., visual analogue scale for pain at 1, 2, 6, and 12 h postoperatively).
Composite outcomes, in which multiple primary endpoints are combined, may make it difficult to draw any conclusions based on the study findings. For example, in a clinical trial, 200 children undergoing ophthalmic surgery were recruited to explore the incidence of respiratory adverse events, when comparing desflurane with sevoflurane, following the removal of flexible LMA during the emergence of the anaesthesia. The primary outcome was the number of respiratory events, including breath holding, coughing, secretions requiring suction, laryngospasm, bronchospasm, and mild desaturation.[ 16 ] Should authors had claimed a significant difference between these anaesthetic volatiles, it would have been important to elucidate whether those differences were due to serious adverse events, like laryngospasm or bronchospasm, or the results were explained by any of the other events (e.g., secretions requiring suction). While it is true that clinical trials evaluating the occurrence of adverse events like laryngospasm/bronchospasm,[ 16 , 17 ] or life-threating complications following a tracheal intubation (e.g., inadvertent oesophageal placement, dental damage or injury of the larynx/pharynx)[ 14 ] are almost invariably underpowered, because the incidence of such events is expected to be low, subjective outcomes like coughing or secretions requiring suction should be avoided, as they are highly dependent on the examiner's criteria.[ 16 ]
Secondary outcomes are useful to document potential side effects (e.g., gastric insufflation after placing a supraglottic device), and evaluate the adherence (say, airway leak pressure) and safety of the intervention (for instance, occurrence, or laryngospasm/bronchospasm).[ 17 ] Nevertheless, the problem of addressing multiple secondary outcomes without the adequate statistical power is habitual in medical literature. A good illustration of this issue can be found in a study evaluating the performance of two supraglottic devices in 50 anaesthetised infants and neonates, whereby authors could not draw any conclusions in regard to potential differences in the occurrence of complications, because the sample size calculated made the study underpowered to explore those differences.[ 17 ]
Among PICOT components, the time frame is the most likely to be omitted or inappropriate.[ 1 , 12 ] There are two key aspects of the time component that need to be clearly specified in the research question: the time of measuring the outcome variables (e.g. visual analogue scale for pain at 1, 2, 6, and 12 h postoperatively), and the duration of each measurement (when indicated). The omission of these details in the study protocol might lead to substantial differences in the methodology used. For instance, if a study is designed to compare the insertion times of three different supraglottic devices, and researchers do not specify the exact moment of LMA insertion in the clinical trial protocol (i.e., at the anaesthetic induction after reaching a BIS index < 60), placing an LMA with insufficient depth of anaesthesia would have compromised the internal validity of the results, because inserting a supraglottic device in those patients would have resulted in failed attempts and longer insertion times.[ 10 ]
A well-elaborated research question may not necessarily be a good question. The proposed study also requires being achievable from both ethical and realistic perspectives, interesting and useful to the clinical practice, and capable to formulate new hypotheses, that may contribute to the generation of knowledge. Researchers have developed an effective way to convey the message of how to build a good research question, that is usually recalled under the acronym of FINER (feasible, interesting, novel, ethical and relevant).[ 5 , 6 , 7 ] Table 2 highlights the main characteristics of FINER criteria.[ 7 ]
Main features of FINER criteria (Feasibility, interest, novelty, ethics, and relevance) to formulate a good research question. Adapted from Cummings et al .[ 7 ]
Component | Criteria |
---|---|
Feasible | -Ensures adequacy of research design -Guarantees adequate funding -Recruits target population strategically -Aims an achievable sample size -Prioritises measurable outcomes -Optimises human and technical resources -Accounts for clinicians commitment -Procures high adherence to the treatment and low rate of dropouts -Opts for appropriate and affordable frame time |
Interesting | -Engages the interest of principal investigators -Attracts the attention of readers -Presents a different perspective of the problem |
Novel | -Provides different findings -Generates new hypotheses -Improves methodological flaws of existing studies -Resolves a gap in the existing literature |
Ethical | -Complies with local ethical committees -Safeguards the main principles of ethical research -Guarantees safety and reversibility of side effects |
Relevant | -Generates new knowledge -Contributes to improve clinical practice -Stimulates further research -Provides an accurate answer to a specific research question |
Although it is clear that any research project should commence with an accurate literature interpretation, in many instances it represents the start and the end of the research: the reader will soon realise that the answer to several questions can be easily found in the published literature.[ 5 ] When the question overcomes the test of a thorough literature review, the project may become novel (there is a gap in the knowledge, and therefore, there is a need for new evidence on the topic) and relevant (the paper may contribute to change the clinical practice). In this context, it is important to distinguish the difference between statistical significance and clinical relevance: in the aforementioned study of Oba et al .,[ 10 ] despite the means of insertion times were reported as significant for the Supreme™ LMA, as compared with ProSeal™ LMA, the difference found in the insertion times (528 vs. 486 sec, respectively), although reported as significant, had little or no clinical relevance.[ 10 ] Conversely, a statistically significant difference of 12 sec might be of clinical relevance in neonates weighing <5 kg.[ 17 ] Thus, statistical tests must be interpreted in the context of a clinically meaningful effect size, which should be previously defined by the researcher.
Among FINER criteria, there are two potential barriers that may prevent the successful conduct of the project and publication of the manuscript: feasibility and ethical aspects. These obstacles are usually related to the target population, as discussed above. Feasibility refers not only to the budget but also to the complexity of the design, recruitment strategy, blinding, adequacy of the sample size, measurement of the outcome, time of follow-up of participants, and commitment of clinicians, among others.[ 3 , 7 ] Funding, as a component of feasibility, may also be implicated in the ethical principles of clinical research, because the choice of the primary study question may be markedly influenced by the specific criteria demanded in the interest of potential funders.
Discussing ethical issues with local committees is compulsory, as rules applied might vary among countries.[ 18 ] Potential risks and benefits need to be carefully weighed, based upon the four principles of respect for autonomy, beneficence, non-maleficence, and justice.[ 19 ] Although many of these issues may be related to the population target (e.g., conducting a clinical trial in patients with ongoing cardiopulmonary resuscitation would be inappropriate, as would be anaesthetising patients undergoing elective LASER treatment for condylomas, to examine the performance of supraglottic airway devices),[ 14 , 15 ] ethical conflicts may also arise from the intervention (particularly those involving the occurrence of side effects or complications, and their potential for reversibility), comparison (e.g., use of placebo or sham procedures),[ 19 ] outcome (surrogate outcomes should be considered in lieu of long term outcomes), or time frame (e.g., unnecessary longer exposition to an intervention). Thus, FINER criteria should not be conceived without a concomitant examination of the PICOT checklist, and consequently, PICOT framework and FINER criteria should not be seen as separated components, but rather complementary ingredients of a good research question.
Undoubtedly, no research project can be conducted if it is deemed unfeasible, and most institutional review boards would not be in a position to approve a work with major ethical problems. Nonetheless, whether or not the findings are interesting, is a subjective matter. Engaging the attention of readers also depends upon a number of factors, including the manner of presenting the problem, the background of the topic, the intended audience, and the reader's expectations. Furthermore, the interest is usually linked to the novelty and relevance of the topic, and it is worth nothing that editors and peer reviewers of high-impact medical journals are usually reluctant to accept any publication, if there is no novelty inherent to the research hypothesis, or there is a lack of relevance in the results.[ 11 ] Nevertheless, a considerable number of papers have been published without any novelty or relevance in the topic addressed. This is probably reflected in a recent survey, according to which only a third of respondents declared to have read thoroughly the most recent papers downloaded, and at least half of those manuscripts remained unread.[ 20 ] The same study reported that up to one-third of papers examined remained uncited after 5 years of publication, and only 20% of papers accounted for 80% of the citations.[ 20 ]
Formulating a good research question can be fascinating, albeit challenging, even for experienced investigators. While it is clear that clinical experience in combination with the accurate interpretation of literature and teamwork are essential to develop new ideas, the formulation of a clinical problem usually requires the compliance with PICOT framework in conjunction with FINER criteria, in order to translate a clinical dilemma into a researchable question. Working in the right environment with the adequate support of experienced researchers, will certainly make a difference in the generation of knowledge. By doing this, a lot of time will be saved in the search of the primary study question, and undoubtedly, there will be more chances to become a successful researcher.
Conflicts of interest.
There are no conflicts of interest.
European network on digital academic history.
L’europa delle università: contesti comuni e peculiarità locali attraverso l’esame delle fonti (origini – xx secolo), universities in europe: common contexts and local peculiarities through source analysis (origins – 20th century).
OpenEdition vi suggerisce di citare questo post nel modo seguente: Kaspar Gubler (26 Gennaio 2020). X. Heloise Workshop 29 – 30 March 2021, Bologna. Atelier Héloïse . Recuperato il 24 Settembre 2024 da https://doi.org/10.58079/phk7
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A hypothesis is a statement you can approve or disapprove. You develop a hypothesis from a research question by changing the question into a statement. Primarily applied in deductive research, it involves the use of scientific, mathematical, and sociological findings to agree to or write off an assumption. Researchers use the null approach for ...
A Hypothesis is a statement that predicts the relationship between two or more variables in a research study. Hypotheses are used in studies that aim to test cause-and-effect relationships between variables. A hypothesis is a tentative explanation for an observed phenomenon, and it is often derived from existing theory or previous research.
Developing a hypothesis (with example) Step 1. Ask a question. Writing a hypothesis begins with a research question that you want to answer. The question should be focused, specific, and researchable within the constraints of your project. Example: Research question.
INTRODUCTION. Scientific research is usually initiated by posing evidenced-based research questions which are then explicitly restated as hypotheses.1,2 The hypotheses provide directions to guide the study, solutions, explanations, and expected results.3,4 Both research questions and hypotheses are essentially formulated based on conventional theories and real-world processes, which allow the ...
The primary research question should originate from the hypothesis, not the data, and be established before starting the study. Formulating the research question and hypothesis from existing data (e.g., a database) can lead to multiple statistical comparisons and potentially spurious findings due to chance.
The first question asks for a ready-made solution, and is not focused or researchable. The second question is a clearer comparative question, but note that it may not be practically feasible. For a smaller research project or thesis, it could be narrowed down further to focus on the effectiveness of drunk driving laws in just one or two countries.
Simple hypothesis. A simple hypothesis is a statement made to reflect the relation between exactly two variables. One independent and one dependent. Consider the example, "Smoking is a prominent cause of lung cancer." The dependent variable, lung cancer, is dependent on the independent variable, smoking. 4.
Creating a research hypothesis to answer a research problem is an iterative process. (Image by rawpixel.com on Freepik) Any research begins with a research question and a research hypothesis.A research question alone may not suffice to design the experiment(s) needed to answer it. A hypothesis is central to the scientific method. But what is a hypothesis?
Research hypothesis. The primary research question should be driven by the hypothesis rather than the data. 1, 2 That is, the research question and hypothesis should be developed before the start of the study. This sounds intuitive; however, if we take, for example, a database of information, it is potentially possible to perform multiple ...
A research hypothesis is your proposed answer to your research question. The research hypothesis usually includes an explanation ("x affects y because …"). A statistical hypothesis, on the other hand, is a mathematical statement about a population parameter. Statistical hypotheses always come in pairs: the null and alternative hypotheses.
A research question has been described as "the uncertainty that the investigator wants to resolve by performing her study ... The hypothesis is a tentative prediction of the nature and direction of relationships between sets of data, phrased as a declarative statement. Therefore, hypotheses are really only required for studies that address ...
A research question is a broad inquiry that aims to explore a specific topic or problem. It is often open-ended and seeks to gather information and generate knowledge. On the other hand, a hypothesis is a specific statement that predicts the relationship between variables or the outcome of a study. It is based on existing knowledge or theories ...
A hypothesis is a testable statement that predicts an outcome, while a research question is a query that you're trying to answer through your study. Naturally, there can be linkages between a study's research questions and hypothesis, but they serve different functions.
The Importance of Research Questions and Hypotheses in Guiding Research. Defining the Research Focus: Research questions serve as the cornerstone of any study, clearly outlining the specific issue or phenomenon that the research aims to explore. They help narrow down the broad area of interest into a focused inquiry that can be systematically investigated.
In research, a research question is a clear and specific inquiry that the researcher wants to answer, while a research hypothesis is a tentative statement or prediction about the relationship between variables or the expected outcome of the study.
Research Questions and Hypotheses I nvestigators place signposts to carry the reader through a plan for a study. The first signpost is the purpose statement, which establishes the ... Designing Research Example 7.3 A Null Hypothesis An investigator might examine three types of reinforcement for children with autism: verbal cues, a reward, and ...
The research question and hypothesis mark your own disciplinary territory and drive your research. Whether you have both a research question and a hypothesis, and whether they are broken down into several sub-areas, will depend on your discipline and topic; but however they appear, it is important that they are clearly formulated. ...
A research question is the question the research study sets out to answer. Hypothesis is the statement the research study sets out to prove or disprove. The main difference between hypothesis and research question is that hypothesis is predictive in nature whereas research question is inquisitive in nature. In this article, we'll discuss,
A hypothesis is defined as an educated guess, while a research question is simply the researcher wondering about the world. Hypothesis are part of the scientific research method. They are employed in research in science, sociology, mathematics and more. Research questions are part of heuristic research methods, and are also used in many fields ...
This entry was posted in Research and tagged research on December 14, 2014. Four key components to a research project are the purpose statement, research questions, hypotheses, and research objectives. In this post, we will define each of these. Definitions The purpose statement provides the reader with the overall focus and direction of a study.
Research Methods by Nicholas Walliman Research Methods: The Basics is an accessible, user-friendly introduction to the different aspects of research theory, methods and practice. Structured in two parts, the first covering the nature of knowledge and the reasons for research, and the second the specific methods used to carry out effective research, this book covers: Structuring and planning a ...
A good research question (RQ) forms backbone of a good research, which in turn is vital in unraveling mysteries of nature and giving insight into a problem.[1,2,3,4] RQ identifies the problem to be studied and guides to the methodology. It leads to building up of an appropriate hypothesis (Hs).
The Null hypothesis \(\left(H_{O}\right)\) is a statement about the comparisons, e.g., between a sample statistic and the population, or between two treatment groups. The former is referred to as a one-tailed test whereas the latter is called a two-tailed test. The null hypothesis is typically "no statistical difference" between the ...
1 M5; Evaluating research questions, hypothesis, & designs Original Post by Annette Spellman It was a pleasure for me to read the article by Hogneses et al. (2015). The article research study was on the effects where music composition is used in a classroom and how that effects academic differences on engagement for music education. The conclusion that was made was that it was useful, at least ...
It is highly unusual for a funding opportunity to allow links in Specific Aims, Research Strategy, and other page-limited attachments. Hyperlinks and URLs may not be used to provide information necessary to application review. Applications must be self-contained and reflect the information available at time of review.
Hence, a comprehensive review of the topic is imperative, as it allows the researcher to identify this gap in the literature, formulate a hypothesis and develop a research question. To this end, it is crucial to be attentive to new ideas, keep the imagination roaming with reflective attitude, and remain sceptical to the new-gained information ...
L'Europa delle Università: contesti comuni e peculiarità locali attraverso l'esame delle fonti (origini - XX secolo) Universities in Europe: common contexts and local peculiarities through source analysis (origins - 20th century) Virtual Conference on Microsoft Teams. To participate in the event, you must register by 15 March at the following email address: [email protected] ...