PHAR 628 Research Methods & Biostatistics Lecture 3 PDF

PHAR 628 Research Methods & Biostatistics Lecture 3: Research Methodology Lixian Zhong, Ph.D. Jan 22nd, 2025 1 Objectives ❖To understand the terminologies related to research methodolo...

PHAR 628 Research Methods & Biostatistics Lecture 3: Research Methodology Lixian Zhong, Ph.D. Jan 22nd, 2025 1 Objectives ❖To understand the terminologies related to research methodology ❖To discuss common research methodologies used in clinical research 2 Research Methodology Research methodology focuses on data collection and measurement techniques. After finalizing a suitable research design, data collection is a critical step in the research process. These techniques can be broadly classified into primary or secondary methods. 3 Research Methodology Primary methods collect data specifically for the research question under consideration. - Pros: collect data that fits the needs and design of the study - Cons: resource intensive Secondary methods for data collection involve the use of data that was collected for a different purpose. - Pros: data already exist - Cons: available data may be limited 4 Research Methodologies Primary Secondary methods methods Biological Medical Assessments Records Medical Observations Claims Research Self-reports Data 5 Research Methods Classification Biological Measures ◦ Biological assessments are made using biophysical, biochemical, and microbiological methods. ◦ Such clinical or laboratory tests require specialized instruments or devices such as electrocardiogram, glucometer, microscope, etc. ◦ Biological measures are objective markers of a disease or patient’s health, and thus play a critical role in clinical research. 6 Research Methods Classification Biological Measures ◦ Biophysical assessments measure physical characteristics such as bone density, blood pressure, and forced expiratory volume. ◦ Examples of biophysical devices include blood pressure monitors, x-ray, computed tomography (CT), electrocardiograph (ECG), ultrasound, and magnetic resonance imaging (MRI). 7 Biological Measures Biochemical methods measure chemical constituents in body fluids such as blood or urine. Blood glucose, urine creatinine, and serum drug levels are examples of biochemical measures. These clinical tests require chemical analysis or assays using instruments such chromatography systems. 8 Biological Measures Microbiological methods evaluate microorganisms such as bacteria or virus in body fluids such as blood or urine. These tests are based on growth of bacterial culture with evaluations involving microscopic examinations. 9 Observations o Researchers use observational techniques to gather data on participant activities, characteristics, communication, interaction, and time taken to complete a given task. ◦ In obtrusive observation, the participant is aware that he/she is being observed. - The participant may alter normal behavior in the presence of the observer ◦ In unobtrusive observation, the participant is unaware of the observer who may be either hidden or under disguise. - May have ethical and legal concerns. 10 Self-reports ◦ Self-reports involve data collection by direct questioning of research subjects. ◦ Using self-reports, data concerning patients’ thoughts and perceptions, attitudes, and behaviors can be collected. - Psych distress - Rx satisfaction - Pain/fatigue - Overall quality of life … 11 Self-reports There are two types of self-report data collection strategies: surveys and interviews. ◦ Surveys – A survey instrument includes a set of questions aimed at collecting data relevant to the purpose of the study. Questions included in the survey instrument could be either open-ended or close-ended. ◦ Interviews – Interviews provide an opportunity to researchers to communicate with the participants and listen to their responses. 12 Surveys Close-ended questions present respondents with specific set of response choices from which they have to choose an answer. E.g. Did you experience any side effects from the medication? [ ] Yes or [ ] No E.g. What side effect did you experience with the COVID vaccine? A. Injection site reaction B. Fatigue C. Fever D. Nausea - Since these questions provide patients with options, they are easier and take less time to answer. The disadvantage of these questions is that they limit the option choices. - Most of the research surveys involve close-ended question for ease of coding and analysis 13 Surveys Open-ended questions give flexibility to the patients (participants) to write responses in their own words. They lack answer choices that patients (participants) could select. E.g. What side effects of the medication are you experiencing? - These questions enable researchers to gather in-depth information on patient experiences and opinions. - The disadvantage of open-ended questions is that they can be challenging and time consuming for patients to answer as it requires patients to contemplate and provide a coherent response. - The open-ended format makes these questions unsuitable for statistical approaches to data analysis. 14 Surveys A survey can be administered through different modes including mail, Internet, telephone, or face-to-face interview (discussed under ‘Interview’). ◦ For mail surveys, researcher typically selects a sample from the list of population of interest and mails them the questionnaire along with a cover letter and postage paid return envelope ◦ To conduct an online or internet surveys, researchers typically use web-based survey solution systems such as SurveyMonkey (www.surveymonkey.com) and Qualtrics (www.qualtrics.com). 15 Survey Example - SF-12 Health Survey https://www.rand.org/health/surveys_tools/mos/12-item-short-form.html 16 Survey Example- Multiple Sclerosis Impact Scale 17  Research Methodologies The decision to use a particular data collection technique is guided by three factors: -Reliability -Validity -Practicality 18 Reliability of Survey Instrument Reliability refers to consistency and reproducibility of results. Results obtained from a measurement instrument should be consistent when measured repeatedly over different time periods. ◦ Test-retest reliability: the extent to which answers to the same instrument correlate when measured in the same sample over different time periods. ◦ Inter-rater reliability: the extent to which results are consistent when the same measurement instrument is used by multiple investigators (reproducibility). 19 Validity of Survey Instrument Validity refers to the extent to which an instrument measures what it is intended to measure. Much of the research in health care involves quantifying attributes that are abstract concepts and cannot be measured directly E.g. Disease severity, drug efficacy/safety, burden of illness, patient satisfaction, quality of life… Measurement of an abstract concept requires that the concept be translated into more concrete indicators. 20 Interviews Face-to-face interviews can be structured, semi-structured, or unstructured. ◦ Structured (or standardized) interviews are those wherein the same set of questions are presented in the same order to all the participants. ◦ Unstructured interviews are non-standardized and flexible; the question-and-answer categories are not predetermined. ◦ Semi-structured interviews include structured questions but often have follow-up and/or clarification questions. Telephone interviews are solely dependent on verbal communication. Most research interviews are structured for ease of coding and analysis 22 23 Research Methodologies Primary Secondary methods methods Biological Medical Assessments Records Medical Observations Claims Research Self-reports Data 24 Medical Records A medical record is a confidential record that is kept for each patient by a healthcare professional or organization. It typically contains - The patient’s demographic information - A summary of the patient’s medical history - Documentation of each event, including symptoms, diagnosis, treatment and outcome - Other relevant document and correspondence 25 Medical Records The main purpose of the medical records: -To provide a summary of a person’s contact with a healthcare provider and the treatment provided in order to ensure appropriate healthcare. -Provides the essential data for monitoring patient care -Provide data for conducting clinical audits -Provide data for assessing pattern of care and service delivery 26 Traditional Paper-based Medical Records 27  Electronic Medical Records (EMR) EMR is a generic name used to describe computer-based patient medical records – digital version of a patient’s paper medical records 28  Electronic Medical Record (EMR) Many different types of patient data can be included in an EMR: -Medical history -Physical examination -Diagnoses -Clinical activities -Lab results -Radiology imaging and results -Electronic prescribing data 29 30 EMR for Clinical Research - Harbors a wealth of health-related information - EMR provides access to a broader and more diverse patient population - EMR systems have integrated data and could speed up data acquisition and searching - EMR systems allow mass sampling and computing 32 Example of Using EMR for Clinical Research: Childhood Obesity and Maternal imprinting 33 Health insurance claims data for Clinical Research - Claims data are designed for billing purposes, not for research - Claims data have detailed information on clinical encounters and costs - They also have data on diagnosis, admission/discharge, pharmacy dispensing - These makes claims data very useful for clinical research as well 34 Example of Health Research Databases National Health Interview Survey (NHIS) https://www.cdc.gov/nchs/nhis/index.htm Medical Expenditure Panel Survey (MEPS) - A set of large-scale surveys of families and individuals, their medical providers and employers across the United States. Data since 1996, funded by AHRQ https://meps.ahrq.gov/mepsweb/ National Health and Nutrition Examination Survey - A database designed to assess the health and nutritional status of adults and children in the US. Data since 1999. Funded by CDC. https://www.cdc.gov/nchs/nhanes/index.htm Surveillance, Epidemiology, and End Results Program (SEER) - Maintains computerized data on cancer incidence, mortality and survival for approximately 28% of the US population in several defined geographic areas. Information gathered from hospital medical records and pathology reports of cancer cases. Data since 1973. Funded by NCI. https://seer.cancer.gov/resources/ 35 Which research methodology is used for this study? A. Primary method B. Secondary method 36 Which research methodology is used for this study? A. Primary method B. Secondary method 37