|Year : 2021 | Volume
| Issue : 1 | Page : 21-27
A magical journey into knowledge creation in emergency difficult airway access - Planning your journey with ‘research genie’
Department of Otolaryngology Head and Neck Surgery, St. John's Medical College and Hospital, Bengaluru, Karnataka, India
|Date of Submission||22-Mar-2021|
|Date of Acceptance||08-Apr-2021|
|Date of Web Publication||29-Apr-2021|
Dr. Ramesh A
Department of Otolaryngology Head and Neck Surgery, St. John's Medical College and Hospital, Koramangala, Bengaluru - 560 034, Karnataka
Source of Support: None, Conflict of Interest: None
This article is the second of a 4-article series intended to ignite the minds of readers and empower them to create new knowledge in the context of ‘emergency difficult airway access'. The aim of this series is to empower readers to create product/process/paradigm/position innovations in emergency difficult airway access for better care of humanity. The reader is familiarised with an educational smart phone-based application - Research Genie. The application has been designed and created by St. John's Medical College Research Society. The reader will be trained in a stepwise manner to use this application. Study design for each domain-specific objective is described. The most appropriate guideline to ensure quality of the study is stated. Explaining study designs using a domain-specific objective imparts ability to choose the most appropriate study design in a particular domain. Nine domains of healthcare have been explored namely description, laboratory range estimation, incidence/prevalence estimation, evaluating therapies, measuring costs in healthcare, critically evaluating new tests, measuring risk, correlating variables and describing experiences, perceptions and beliefs. Principles of sampling strategy have been explained in a simple and lucid manner.
Keywords: Sample size, sampling strategy, study design
|How to cite this article:|
Ramesh A. A magical journey into knowledge creation in emergency difficult airway access - Planning your journey with ‘research genie’. Airway 2021;4:21-7
|How to cite this URL:|
Ramesh A. A magical journey into knowledge creation in emergency difficult airway access - Planning your journey with ‘research genie’. Airway [serial online] 2021 [cited 2021 Jun 20];4:21-7. Available from: https://www.arwy.org/text.asp?2021/4/1/21/315158
| Introduction|| |
This article is the second of a series of four intended to empower medical personnel in creating a pathway for knowledge creation in managing emergency situations where securing airway access is difficult. The process of knowledge creation involves sequential steps of well-defined actions. The first step is to define a challenging healthcare situation in a target population and ask questions in various domains of healthcare. This is followed by creating a conceptual framework, where the outcome (Dependent variable) and variables influencing the outcome (Independent variables) are concisely defined. This defines a path for action. In the first article of this series, this process has been explained in a clinical context of accessing airway in an emergency situation. The reader should understand this process from the first article titled ‘A Magical Journey into Knowledge Creation in Emergency Difficult Airway Access-Defining the Destination, Reserving your Seats on the Magic Carpet’ published in the September-December 2020 issue of the Airway journal. In this article, you will understand the entire process of creating knowledge with the assistance of an educational smart phone application (App)-'Research Genie'. This App has two components. The first schematically depicts the entire process of asking a research question and finding an answer which can be used to make a difference in the world. The second is an interactive section for the users to plan their journey in knowledge creation in emergency airway access.
The magical journey continues …….
| Inviting the “Research Genie” to Your Smart Phone|| |
The ‘Research Genie’ (RG) is a smart phone-based educational application. It will be referred to as RG from here onwards. RG was designed by a team at St. John's National Academy of Health Sciences, Bengaluru. The purpose of RG is to simplify understanding of research methodology for medical personnel. Further, it assists in designing studies to answer research questions arising in challenging healthcare situations. In the process, healthcare personnel get proficient in the skill of knowledge creation. RG can be installed from Playstore for android and App Store for i-phones (Apple). It occupies limited space on the phone memory storage and does not require internet connection once installed. In our experience, the installation gets stalled in certain users. In such situations, it has been observed that the reason is automatic updating of all Apps installed on the smart phone when it gets connected to the internet. This issue can be solved by turning ‘off’ automatic updates of Apps in the settings. RG was created with the primary intention of demystifying research methodology. There is no commercial benefit accruing to any individual or institution by your using it. You may install RG App on your smart phone at this point of time before we go further.
| Rubbing the Magic Lamp to Summon ‘Research Genie'|| |
'Aladdin and the magic lamp' is one of the tales in ‘One thousand and one nights'. The magic genie comes out of the lamp on rubbing it. The RG comes to your assistance by swiping the screen of your smart phone. Your smart phone is the magic lamp in your journey of knowledge creation.
| Research Genie to Assist in Concisely Defining Target Population|| |
To understand this section, install RG on your smartphone and follow each instruction. When you tap on the RG icon, the first page opens. You swipe it from right to left and the ‘Home page’ comes in view. The Genie is awake and at your service to take you on the magical journey of knowledge creation. The header of the home page is ‘The Group of People I want to make a Difference by Research'. Below that is a box mentioning ‘Define your target population……..’ as a watermark. Watermark is a faded type of writing on an area to inform the viewer about what needs to be typed there. On tapping this box, another window opens with the same heading with two blank boxes separated by the word ‘WITH’. The first box has ;(Group of...)’ mentioned as a watermark. In this box, you enter the age category. In the box after ‘WITH’ with a watermark ‘(Disability...)’ you type the medical issue faced by this age category. In our case it can be ‘Patients in emergency’ WITH ‘Difficult airway access'. Each box can accommodate 15 characters, so you need to abbreviate the terms. One way is ‘People in Emerg’ WITH ‘Diff airway acc’. The bottom left corner has a circle with query symbol. On tapping this, examples of target population appear. This may further assist you in filling these two boxes. Tap on ‘Got it’ to go back to previous page. After typing in the two boxes, tap on the right bottom corner circle with tick mark to reach the home page. These two boxes facilitate in concisely defining the target population. The population defined by you appears in all the windows of the interactive section of RG. It keeps you in perspective lest you meander off the dark and dangerous alleyways of research methodology and statistics. A clear perspective gives a meaning to the work of knowledge creation. You can pledge and renew your pledges for making a difference in the lives of people presenting to the emergency with difficult airway by finding solutions to challenging healthcare issues in that context. In the first part of this series, you will get a glimpse of the difference in various domains that can be made by knowledge creation. After defining the target population, you list the various challenges and categorise them as one of the nine domains namely Description, Lab range, Incidence or Prevalence, Therapy, Cost, New test, Risk measurement, Correlation and Belief/Perception/Experience. All these domains have been described in the first part of this series. On the home page, tapping on ‘Domain’ opens a page with nine boxes displaying these nine domain names. This is the interactive section of RG. We will learn about it after a few sections. You can tap on the circle with a back arrow to return to the home page.
| A Glimpse into the Shining and Shimmering World of Knowledge Creation|| |
RG gives you a quick, simplified and schematic glimpse to the world of knowledge creation. The ‘Intentions’ box opens to the main purposes of research methodology. It starts with identifying challenging healthcare situations, performing a review of literature to find if previous researchers have answered this question and finally design a research study to create knowledge to answer the question. It is also emphasised that understanding of the process of knowledge creation is important for healthcare personnel to critically evaluate existing knowledge base and utilise them in the best interest of people seeking medical care. You can navigate back to the home page by clicking the home icon. ‘PICOT’ box in the home page pictorially describes all the components of a research question. In the first part of this series all the components of a research question were described in the context of an emergency room scenario. You can navigate back to the home page by clicking the home icon. The ‘Distill’ box depicts distilling objectives from a challenging healthcare situation. The entire process of framing specific objectives for each domain is explained in the first part of this series. You can navigate back to the home page by clicking the home icon.
The key box is ‘Design'. On tapping this box, a schematic diagram showing the design of research methodology (knowledge creation) comes into view. This diagram simplifies the entire process for easy assimilation. The following section details this key diagram.
| Design of Knowledge Creation (Research Methodology)|| |
[Figure 1] is an innovative depiction of the design of research methodology. An understanding of this empowers you to unravel all the mysteries regarding research. The first step is to ask a question in the universe. This has been explained in the first article on the series. The next step is to choose the study design. RG has a limitation; it cannot assist you in choosing the study design because unfortunately RG cannot think. You have to do the thinking. The next few sections will empower you to think and identify the most appropriate design to answer various objectives that were defined in part 1 of this series.
| Description Objective|| |
To estimate the proportion of emergency situations with difficult airway access (Outcome/Event) in people presenting to emergency rooms of district level hospitals of India (Population).
The study design best suited to answer this type of objective is Cross sectional study (Observational design). It can be prospective where you start counting the emergency situations with difficult airway access (Outcome/Event) in people presenting to emergency rooms of district level hospitals of India (Population). If the quality of data recording is optimal in emergency rooms of district level hospitals, then a retrospective study is also appropriate. The quality of these types of studies is evaluated using the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines which is available in the ‘Equator guidelines’ website.
| Lab Range Objective|| |
To estimate the time taken to secure a stable airway (Outcome/Event) using a supraglottic airway device in unstable patients with open mandibular fractures (Population) presenting to emergency room.
Here again the most appropriate design is Cross sectional study (Observational design).
| Incidence or Prevalence Objective|| |
To estimate the prevalence of death/irreversible brain hypoxia (Outcome/Event) in patients presenting to emergency rooms of district hospitals (Population) manned by inadequately trained airway managers.
The most appropriate design in this situation is Cross sectional study (Observational design).
| Therapy Objective|| |
To compare the efficacy of securing the airway (outcome) in patients presenting to emergency rooms of district hospitals with restricted mouth opening (Population) using supraglottic airway device (Intervention 1) versus fibreoptic-guided intubation (Intervention 2).
This category of objective is best answered by randomised controlled trials (RCTs). The main intention of randomisation is to eliminate selection bias and achieve balance of prognosis. Human beings by design are biased either intentionally or unintentionally. By randomisation, we eliminate control of the researcher over allotting cases to supraglottic airway device group or fibreoptic-guided intubation group. Randomisation limits both known and unknown confounding factors (refer to first article for understanding of ‘confounding factors'). This ensures a valid outcome. The Consolidated Standards of Reporting Trials is the most appropriate guideline to ensure quality of RCTs.
| Cost Objective|| |
To compare the cost (Outcome/Event) of using supraglottic airway devices (Intervention 1) and fibreoptic-guided intubation (Intervention 2) in patients presenting to emergency rooms of district hospitals with restricted mouth opening (Population).
Measuring costs in healthcare comes under the purview of health economics. Health and economics are mutually opposing domains. Health is emotional and personal whereas economics is concise and clinical. There are primarily three types of economic analysis-namely cost effectiveness analysis (CEA), cost utility analysis and cost benefit analysis.
CEA measures cost incurred per unit change of a clinical parameter (e.g., rupees spent to reduce one death due to asphyxia in patients with difficult airways). The results of CEA assist the clinician in choosing the most effective intervention.
Cost utility analysis estimates cost to change health utility measures in a given context. Disability adjusted life years (DALYs) is an example of a utility measure. It is a measure of individual burden of disability derived from large scale population studies. These measures are available from the Global Burden of Disease study. Many countries have developed nation-specific utility measures. Suboptimal management of difficult airways can lead to asphyxia with long term disability. So, cost to reduce one DALY by various interventions in difficult airway is an example of cost utility analysis. As utility measures are standardised across populations, cost utility analysis can be used to compare various interventions across different contexts. These comparisons are tabulated as Stochastic League Tables. Forgive me if this was too much to comprehend. Nevertheless, health economic analysis is the key determinant for policy and a clinician managing difficult airway can use these tools to convince hospital managers to invest in advanced facilities for airway management.
Cost benefit analysis measures the economic benefit that individual gains by his earning in terms of cash income for the amount spent for the health condition. In our context, it will be the earning capacity in terms of rupees a person benefits when we prevent disabling brain injury due to asphyxia by optimally managing the difficult airway. In simple terms, it is money earned for money spent.
Clinicians must be familiar with these designs as it can give them the ability to make prudent choices, understand the economic benefits to individuals by medical interventions and assist in conveying their views to hospital management. The Consolidated Health Economic Evaluation Reporting Standards guideline is the most comprehensive method to ensure the quality of health economic studies.
| New Test Objective|| |
To compare the accuracy of decision-making smart phone-based application (new test) to predict probability of securing the airway using a supraglottic airway device (outcome/event) among patients presenting to emergency rooms of district hospitals with restricted mouth opening (population).
Validation design is the most appropriate study design to answer this category of objective. Here various characteristics of the new tool are estimated based on the reference test. In this objective, smart phone-based application is the new test and securing the airway is the reference for validating the accuracy of smart phone-based application. Various characteristics of the new test are described in terms of validity, reliability, sensitivity, specificity, positive predictive value, negative predictive value, accuracy, precision, efficiency and likelihood ratio.
Validity is a measure of whether the instrument measures what it is supposed to measure. In our objective, this is derived by comparing the prediction by the smart phone App and real-time access of the airway in the situation. Reliability is a measure of the consistency with which a research instrument yields results. Expressed in simple terms, a reliable instrument is one which yields the same results every time it is applied to the same subject by different testers (Inter-tester consistency) or different subjects by same tester (Intra-tester consistency). Sensitivity is a measure of how well the test detects the condition. If the disease being screened is a potentially life-threatening condition, then we need high sensitivity and can compromise on specificity. Specificity is a measure of how well the test excludes people without the disease. Positive predictive value is a measure of the probability of the disease being present if the test is positive. Negative predictive value is a measure of the probability of disease not being present if the test is negative. Accuracy and efficiency is a measure of what proportion of tests will give the correct result. Hence, it is a combination of sensitivity and specificity. Likelihood ratio of positive test is a measure of how much more likely the test will be positive in a person with disease compared to those without the disease. We recommend you learn these concepts in detail if you plan to conduct validation studies.,, Once you understand the concepts, calculation of these values can be performed using online calculators. The recommended guideline to ensure quality of validation studies is Standards for the Reporting of Diagnostic Accuracy Studies.
| Risk Measurement Objective|| |
To estimate the risk (outcome/event) of having death/irreversible brain injury (outcome) in emergency airway management by residents trained using conventional observation training (at-risk group) in comparison to those trained using advanced simulators with embedded training algorithms for optimal positioning and transport (not at-risk group).
In this type of study, we can use two types of designs. A case-control and matched cohort designs are the most appropriate study designs to answer these objectives. In case-control design, the event has occurred and for each case an age and gender matched control is chosen. In matched cohort designs, two cohorts, one with exposure and another without, is followed up to observe occurrence of the event. In our context, we will follow up residents trained using conventional observation training (At-risk group) and those trained using advanced simulators with embedded training algorithms for optimal positioning and transport (Not at-risk group). The occurrence of death/irreversible brain injury (Outcome) in emergency airway management by each group will be compared. If we design it as a case-control study, then we will select cases with death/irreversible brain injury (Outcome) in emergency airway management and have age and gender matched controls without the outcome during emergency management of airway. Then in each group we will examine the number of cases managed by residents trained using conventional observation training (At-risk group) and those trained using advanced simulators with embedded training algorithms for optimal positioning and transport (Not at-risk group). Case control and cohort designs are classified as observational analytical studies, so the quality of these types of studies are evaluated using the STROBE guidelines.
| Correlation Objective|| |
To estimate the strength of correlation (outcome/event) between time spent on accessing the difficult airway by training using advanced simulation systems measured as hours of training (Quantitative parameter 1) and time to secure airway (measured in seconds) in an emergency situation with restricted mouth opening (Quantitative parameter 2).
The data for parameters that are correlated are collected from observational studies. So, the design in these types of objectives is observational analytical. It is analytical because two variables are correlated. Here again, STROBE guidelines are most appropriate to evaluate the quality.
| Beliefs/Perception/Experience Objective|| |
To describe the perceptions of hospital managers and finance authorities about investing in advanced airway access training simulators.
These types of objectives explore an entirely different domain in comparison to all the previous objectives. In these situations, in-depth interviews, focus group discussions and ethnographic observations are employed to describe beliefs, perceptions and lived experiences of people in various contexts. In our context, hospital managers will be interviewed using an interview guide. The guide will have various probes to elicit their perceptions about expensive gadgets to manage difficult airway in emergency situations and also the simulators to train residents and faculty in difficult airway situations. The interviews are recorded and transcripted. Themes are derived from the written transcripts. In another approach, theories grounded in the data can be conceptualised. All these designs are called qualitative study designs., Adequate training is required for conducting these types of studies. Though the data may appear abstract, specific guidelines have been developed to evaluate the quality of these study designs. A Standard for Reporting Qualitative Research is a comprehensive checklist for ensuring the quality of this type of design.
The study design is determined by the objective. So once again, it is emphasised that you frame the study objective precisely.
| Research Genie for Accurately Defining Objectives|| |
RG can assist you with accurately defining the objectives. While on the home page, selecting the ‘Domain’ box will open up nine domains. Each domain relates to the category of objectives we have defined. As a researcher, you have to choose the area that is relevant to your research question. On selecting a specific domain, the window that opens has a sample research question, an objective consistent with the question. In the lowermost line a blank template is available for populating the blanks with Population, Intervention, Comparator and Outcome (PICO) relevant to your research question. RG channels your thoughts towards the destination. Beside the objectives, you can see pictorial representation of the data that fits the objective. You should be clear regarding the data pattern to be grounded in choosing the correct objective. The data patterns are self-explanatory.
| Research Genie for Sampling and Sample Size Calculation|| |
The sample must be representative of the universe (target population). Correct sampling ensures generalisabilty of results. Put simply, results of the study are generalisable if they can be applied on individuals from the community. There are two components to select a sample. One is the sampling strategy and the other is sample size calculation. The objective determines sampling strategy. If universe of the study is hospital-based and the objective is answered by observational design, then convenience sampling is most appropriate. Here you select cases as they come to attend the service. In community-based objectives, usually a random sampling is employed. It may be simple, systematic or cluster random sampling. For clinical trials involving therapy-based objectives, there is randomisation to two or more groups. RG cannot choose the sampling strategy. It requires you to think and choose the most appropriate sampling strategy. After you have decided on the most appropriate sampling strategy, then the RG can assist you with the data required to calculate sample size.
The next article in this series will be on using the RG to derive data required to calculate sample size and also deal with statistics. The word statistics sends shivers down the spine of seasoned physicians. We will demystify sample size calculation and biostatistics with the assistance of RG. As recommended in the first article, choose a research question relevant to your specialty and utilise this series of articles to get proficient in the science of knowledge creation. Till then, have an interesting time getting familiar with ‘RG-At your service in the journey of knowledge creation'. The Genie will answer queries at ‘[email protected]'
Dr. George D'Souza, Dean, St John's Medical College for administrative support.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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