Various Methodological approaches in Medical research: Using exemplars to understand each method and its implications
Athira B1., Elsa Sanatombi Devi2, Viji P C3, Girish Thunga4
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences,
Manipal Academy of Higher Education, Manipal, India
2Department of Medical Surgical Nursing, Manipal College of Nursing, Manipal Academy of Higher Education, Manipal, India
3Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences,
Manipal Academy of Higher Education, Manipal, India
4Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences,
Manipal Academy of Higher Education, Manipal, India
*Corresponding Author E-mail: girishthunga77@gmail.com
ABSTRACT:
Mixed method of research involves both qualitative and quantitative data which helps to unravel complex research questions. This method has recently obtained popularity in medical research as it provides complete analysis of a research question. Although both quantitative and qualitative methods are different, one is not superior to the other. Both the methods have its own pros and cons. But the concurrent use of these methods would help to fill out, complete or extend the information. In this article, we have showcased how each of the method is appropriate to address a research question by using exemplars (Model case studies, prepared by authors.) and what more can done in the current scenario.
KEYWORDS: Mixed method, Qualitative research, Quantitative research, Case studies.
INTRODUCTION:
Quantitative research deals with the numerical representation of data analyzed statistically, while qualitative research deals with non-numerical data2. Many researchers and educators give different definitions for both.
Qualitative research:
Qualitative research is a type of scientific research, exploratory by nature and deals with non-numerical data in detail. The strength of qualitative research is its ability to accommodate complex textual descriptions of how people experience a given research issue. It provides cognizance about the “human” side of an issue like contradictory behaviors, beliefs, opinions, emotions, and relationships of individuals3. Qualitative research depends on its validity, skills, training, insights, and capabilities of the researcher at every stage. Observations, interviews and focus group discussions are the types of qualitative research methods more often used by researchers.
Though Qualitative research methods are widely using in market research, it has recently been categorized as an approach for conducting medical research.
Qualitative research methods in medical research help in:
· Seeking an answer to the question;
· Formulating a hypothesis for further testing and development of the concepts and theories;
· Developing a questionnaire; and
· Understand the feelings, values, and perceptions that underlie and influence behavior.
Methods of Data collection in qualitative research:
There are mainly two methods for data collection about a situation, person, problem or phenomenon. In most of the situation, we need to be collecting the required information or data. However, sometimes the data is already available and the information has to be extracted. Based upon the data collection, the data is classified into Primary data and Secondary data. Data which is collected from the primary source is Primary data. Examples of primary sources include observation, interviews, and questionnaire. Finding out perception of a community towards a new product in market, ascertain the needs of a community, evaluating customer satisfaction etc. are examples of qualitative research. Examples of secondary data include finding out prescription pattern of a medicine from hospital records, gender ratio from census, or collection of data from articles, journals, periodicals, and magazines.
Observation:
Observation is a purposeful and systemic way of collecting data on naturally occurring behaviors or on phenomenon as it takes place. Observation is classified into two that is, participant observation and non-participant observation. In the former, the observer engaged in the ongoing activities and record the observations; and in latter, the observer observes passively from a distance without participating in the group activities4.
Case study 1:
Non Participant observation:
Research question:
Do MDR tuberculosis (TB) patients receive proper care and support from health care settings?
Objective:
To study the care of dying patients suffered from MDR tuberculosis
Case scenario:
A 42-year-old man suffering from MDR TB (critically ill) was admitted in the pulmonology isolation unit. His blood pressure, breathing and heart rate kept on changing. He was responsive and showed breathlessness.
At 10 a.m.:
He was moved to the pulmonology isolation unit ICU. Two nurses attended him for 10 mts. They checked the chart at the foot of his bed and left the ICU by 10.13 a.m.
At 10.45 a.m.:
The patient sputum was blood stained and started high grade fever. He was unconscious and his breathing was loud and noisy. Junior Physician attended him for 3 mts.
At 10.55 a.m.:
The nurse re-entered and changed the infusion as instructed. She realized there was a difficulty for infusion. Death was certified as having occurred at 10.55 a.m5 .
Case analysis:
Here, the third-party observation (between dying patient and nurse, ward rounds, between doctors and nurses) was used as a data collection method as it allowed us to see directly what other people did. The observer had a checklist of data that he needed to collect. The observer recorded all the activities in a timely manner and analyzed. Other Method would not reveal the poor patient care received. Here, the researcher took part in the study with their knowledge but without taking an active part in the situation. It helped to understand how people enact their roles and behaved in particular situations.
Future implications:
Here, we can ensure whether the dying patient received the adequate care required as per guidelines5. The optimal end of life care is not available for all patients who die in hospitals6. What is most important for patients with palliative care and their families could be revealed by qualitative research as it measured the perception of people by different methods. Physical care, Psychological care and social care for the dying patient and their families has to be ensured by health care professionals.
Case Study 2:
Participant Observation:
Objective:
To explore the TB patients’ perceptions on Anti tubercular therapy (ATT) (ATT and reasons for non-adherence)
Case scenario:
A study was conducted in a 30-bed inpatient ward of a pulmonology department to explore the TB patients’ perceptions on ATT and the reasons for its non-adherence. The research method used was participant observation with a passive level of observer at the inpatient-inpatient interaction, the inpatient-physician interaction and the inpatient-nurse interaction. The handwritten field notes and audio taping were collected.
Case analysis:
The observation from the conversation with the natural patients revealed common issues that might not have been revealed in the other method. The observer was able to assess the experience of the TB patients with ATT regarding health problems, high dose of medications, adverse drug reactions, care and support they received from society, etc. These narratives weaved together emotions, physical symptoms, spiritual concerns, and stress they experienced from family life as well as from their professional life and personal challenges. It captured the diversity in people and in their aspirations and ideals as well.
Future implications:
Direct observation therapy is a method endorsed by World Health Organization (WHO) to promote the adherence of medication by health care providers, community workers or, family members to observe and record patient taking each dose. But do we really DO (Direct Observation)? A study by Stella Benbab et al7revealed that “Strict DO” was rarely followed and the reason for not implementing DO was due to lack of availability of directly-observed therapy (DOT) provider, time, stigma, and treatment adverse events. WHO endorsed end TB strategy by combining biomedical and social interventions to tackle TB, as the treatment of TB is more challenging than the disease, not everyone diagnosed with TB start the TB treatment and many a lives have been lost to due to lack of follow-up cases. Qualitative studies would have a greater impact on the TB case findings and practices where human perceptions are involved and can contribute significantly in the End TB Strategy8.
Interviews:
The interviews were conducted for collecting data on the individual person’s experiences and perceptions. Unstructured interview and Structured interview were the types of interviews used. There was no order of questions in the unstructured interview and the researcher had the complete freedom to ask questions and pause issues impulsively depending upon what occurred in the context of discussion. But in the structured interview, there was a predetermined set of questions.
Case Study 3:
Interviews:
Objective:
To explore the knowledge of TB patients about their rights and responsibilities at the Chest Disease Unit of a tertiary care hospital.
Case scenario:
A 59-years-old patient with pulmonary TB was admitted in the pulmonology department. A researcher approached him to find out his perceptions about the rights and responsibilities of TB patients. The researcher made pilot tested interview protocol which contained questions to maintain the consistency. Before the Interview, the researcher explained the purpose of the study and that the participation to the study would not affect their treatment plan. They asked in detail about the behavior of the health care professionals, their assess to medicines, moral support and stigmatization, dignity and complaints.
Case analysis:
Here, the data collection method was structured interview. The Interviews were useful for getting the story behind the patients’ experiences. The patients were usually reluctant to reveal information regarding the behavior of the health care professionals, their assess to medicines and their complaints as they thought it would affect their treatment plan. The interviews would particularly be helpful in such situation as provided privacy and confidentiality. It helped the researcher to get a complete picture about the situation the patient was going through or, about the complaint the patient had or, about what the patient expected from the treatment. Managing a chronic disease is quite difficult as the treatment is more challenging than the disease. So, without considering the patient’s perception we cannot control or manage chronic diseases.
Future Implications:
Managing chronic disease especially in older patients is very challenging and providing adequate information and support to them is critical. Most of the chronically ill patient wishes to hide their illness, but have a strong desire to manage and be socially involved9. Thus, there is a strong need for improving the accountability in between health care providers and the patients, active policy for sociocultural and psychological improvements that can reduce patient stigma as well as strengthen social support. Qualitative studies are helpful in this scenario as it can assess feasibility, barriers, and facilitators for implementing patient-centered plan.
Focus group discussions (FGD):
Focus group discussion is a method of qualitative research, intended to gather information from a homogenous group of people having similar background or having some common characteristics. It has been widely used in market research as an exploratory tool for many years, but nowadays its popularity has increased in other areas such as medical research, education and decision-making10.
Why FGD:
FGD provides an in-depth information and helps to resolve conflicting information. The participants were allowed to interact freely and encouraged to share their perception, experiences, and attitudes. The groups need to be large enough to produce rich discussion but not so large to avoid conflict11.
Online FGD - new method to explore:
Boom in Internet users, high-speed broadband, and new technology platforms have made it easy to extend a range of FGD to online setting.12 One of the key limitations of FGD is to identify, recruit and gather people in a single place for discussion13. People all over the world may not be mobile for physical or economic reasons, busy or unavailable at times, but the use of Internet have made them reachable. Technology have lessened these flaws and have eliminated the shortcomings if not entirely and have made participation of a broad range of people a possibility14,15.
Steps for online FGD:
1. Identify the participants for the FGD;
2. Write a mail to them enquiring their willingness to participate, and briefly describe the purpose of focus group discussion;
3. Get their consent for participation;
4. Inform the date and the time to carry out the FGD;
5. Ensure all of them have high-quality network connection;
6. The team conducting FGD includes the researcher, who is the facilitator and a recorder;
7. The participants are welcomed and asked a set of pre-determined questions;
8. Let the participants discuss freely to the open-ended questions;
9. Record the session; and
10. The FGD will be culminated by appreciating the participants for their participation.
Case scenario:
The FGD was conducted in different hospitals to find out the major causes of treatment default in TB. The study participants were the TB diagnosed patients comprised of both the genders. The participants were informed in prior about the objectives of the study and had taken their consent. Based on their convenience, the FGD was arranged in a private place. They were assured that the confidentiality would be maintained and it would never affect their treatment plan. The moderator asked the pre-determined questions and allowed the patients to interact freely. The entire session was audio recorded. The session ended by appreciating the participants for their active participation.
Case Analysis:
The FGD provided an in-depth knowledge about an issue as it allowed free interaction between the participants. It would help to get detailed information about the personnel and the group feelings, perceptions and opinions. It could save money and time too.
Future implication:
The FGDs required careful and tedious planning, followed by an intricate analysis. Also, it could produce high quality data if used appropriately and judiciously. The FGDs can be included at any stage of research as it offered opportunity to explore issues that are not well understood or on issues where there were a little research on the topic16. Though the interactive element has made focus groups ideally suited to explore issues related to medical and health research, it still remains an invaluable tool to medical and health care research.
Quantitative methods:
Quantitative methods typically comprise methods to quantify phenomena, associations or relationships between variables as well as for proving or disproving a hypothesis. Examples of quantitative research in medical science are association between smoking and lung cancer, patient education and compliance and prescription pattern of a drug. Common approaches to quantitative research are surveys, exploratory research, descriptive research and experimental research17.
Types of surveys:
Surveys as an approach to quantitative research are common in medical research. They are useful for non-experimental descriptive designs that seek to depict reality and can be used to collect information on perception, attitude, behavior, knowledge, and belief of the respondents using a Questionnaire. Questionnaire is an instrument or tool that contains series of questions or statements to collect the information, which can be turned into variables under investigation.
Surveys are classified mainly into three types: oral, written and electronic. Written surveys are further classified into: mail surveys, self-administered or group-administered questionnaires, interviewer-administered questionnaires, and drop-off surveys. The factors affecting a successful survey will be cost, time to complete and access to potential respondents.
There are two types of self-administered questionnaires: supervised and unsupervised. In the former, the involved respondents answer the questionnaire in the presence of the surveyor and in the latter, it is done without the presence of the surveyor. Compared to other methods, the self-administered surveys are much easier, economical and cover wider geographical areas18.
For example, a researcher might be interested in accessing the acceptance, perception, and attitude of an online education program among graduates. The following are the steps for conducting a survey:
1) Design a questionnaire by referring textbook, journals, periodicals and informal discussion with experts;
2) Validate the questionnaire with the help of experts (To find out whether the contents are adequate, appropriate, and relevant);
3) Based on the content validity index, modify the questionnaire;
4) Conduct a pilot study;
5) Administer the questionnaire to target population; and
6) Tabulate the responses and highlight the need for development of an online education program.
Case study:
A questionnaire survey research was conducted to assess the knowledge of TB among students who have not received any clinical curriculum. A validated questionnaire as per the guidelines was used to get the information. The target population and the sample size was determined at the beginning of the study. The researcher visited the universities and conducted the survey.
Case analysis:
Surveys are most frequently employed study design in healthcare research as it is easy to undertake and are less costly. Design, development and validation of the questionnaire is important in a survey research. The target population and sampling is also cardinal. And so, in this study, the case scenario research question, target population, and sample size were well-defined at the beginning of the study.
Mixed method of research:
There is always precedence to develop methodologies to improve quality and scientific power of data in health care research which will also pave the way to methodological diversities. This diversity signals various issues that are faced such as population disparities, age groups, ethnicities, culture, poor treatment adherence and many more. Contributing to this, the mixed method of research has attained acceptance and its popularity among researchers and the science funders is increasing as it helps to provide complete analysis to unravel the complex research questions.
Research methodology in mixed method can be applied based on two classes namely the concurrent and the sequential designs, depending on purpose of employing the mixed method. In the concurrent design, the qualitative and the quantitative methods are used concurrently or simultaneously to analyze and validate the data. For example, Sharkey et al19 conducted a study on “An exploration of factors affecting the implementation of a randomized controlled trial of a transitional discharge model for people with serious mental illness” in which they conducted a qualitative study of factors affecting the implementation of randomized controlled trial parallel to the trial’s quantitative assessment of the effectiveness of a transitional discharge model for people with a serious mental illness. A study on “Implementation of evidence-based practice in child welfare: Service provider perspectives” by Pralinkas etal20 simultaneously collected qualitative data through annual interviews and focus groups and quantitative data through semi-annual web-based surveys to assess the process of implementation of Safe Care.
In sequential design, qualitative and quantitative methods are used sequentially, for example the researcher can use interviews and focus groups for the development of the content of the questionnaire. Elkami et al 21conducted a study on the knowledge and perceptions about pharmacovigilance of the students of Pharmacy in Malaysian public universities. Quanjel T et al22 conducted a mixed method research involving qualitative evaluation and quantitative observation in cardiology primary care plus intervention.
Mixed method of research is the use and integration of both the qualitative and the quantitative research methodologies in one research study to address one omnibus research question. In this method, the qualitative method is used to explore and procure a deeper understanding of the study, while the quantitative method is used to test and confirm the hypothesis. The method is important for understanding complex patient behaviors in chronic diseases such as diabetes, hypertension, and cardiovascular disease and for the design and implementation of strategies to promote the implementation of evidence-based medicine23.
CONCLUSION:
As per the study, it can be concluded that although both the methods are different, one is not superior to the other. Both the methods have its own recognized strengths and weaknesses. But the concurrent use of these methods will help to fill out, complete or extend the information. Research by using mixed method provides broader perspective of a particular research question and an in-depth insight and cognizance about facts.
ACKNOWLEDGEMENT:
We would like to thank Manipal Academy of Higher Education, Manipal, Karnataka, India.
AUTHOR CONTRIBUTIONS:
Contributor 1 is responsible for the conception or design of the work, literature review, data acquisition, and manuscript writing. Contributor 2 made significant contribution to the literature review, manuscript writing and editing. Contributor 3 is responsible for literature review, data acquisition and manuscript editing. Contributor 4 is the corresponding author of this article. His contributions included concept of the paper, study design, manuscript review and feedback on the final presentation of the paper. All authors of this paper have complete access of all study data and agreed to be personally accountable for the author’s own contributions.
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Received on 21.06.2019 Modified on 27.07.2019
Accepted on 30.08.2019 © RJPT All right reserved
Research J. Pharm. and Tech. 2020; 13(1): 485-490.
DOI: 10.5958/0974-360X.2020.00094.3