Research Protocol Critique

Cristal Ann Laquindanum-Tan, MD, MBA, DPPS

UP MS Health Informatics
MI 229
1. Research Question is not stated
● statement should at least broadly indicate to the reader what is to be studied (Coughlan,
et. al, 2007)
● PEO/PO (population, exposure, outcome/ population, outcome)
● Statement of the problem: low productivity, increase in cost of health services, poor
patient satisfaction
● QUANTI: Will an ambulatory surgery unit improve the health care services in a government hospital?
(increase productivity, decrease cost, improve patient satisfaction)
● QUALI: Among physicians and patients, what are the practices, perceived benefits, and barriers into
having an ambulatory surgery unit in a government hospital
2. Research Objectives are not SMART

● The purpose of the aims and objectives of a study, the research question and the research
hypothesis is to form a link between the initially stated purpose of the study or research problem
and how the study will be undertaken (Burns and Grove, 1999).
● The study aims or objectives emerge from the study questions/ hypothesis.
● Specific, Measurable, Attainable, Relevant, and Time-bound

“To determine the acceptability if an ambulatory surgery unit in a government hospital.”

3. One of the specific objectives is just a redundancy of the general objective

● The formulation of objectives helps to focus the study and to avoid the collection of
any unnecessary data and hence organize the study in clear and distinct stages. (Al-
jundi, 2016)
● Specific objectives should lead to the achievement of the general objective
○ GENERAL: To determine the acceptability if an ambulatory surgery unit in a government
hospital.
○ SPECIFIC: To determine if the alternative method of providing surgery will be accepted by
both the physician and the community.
4. Research Design is too broad (and inconsistent)

● Importance of acceptability studies: Physician and/or patient acceptability

is fundamental in the success of a product/service implementation
● Descriptive study → Qualitative Descriptive Study → Mixed-Methods
Research
○ RRL – talks about cost effectiveness
○ Statement of the problem – talks about low productivity, increase in cost of
health services, poor patient satisfaction
○ Matrix of objectives and research design – talks about both quanti and quali
data
5. Wrong sampling technique

● Quantitative = aim is generalizability

● Qualitative = aim is saturation
● In order to select a sample that is likely to be representative and thus identify
findings that are probably generalizable to the target population a probability sample
should be used (Parahoo, 2006).
● Purposeful sampling instead of random sampling for interviews
○ Purposeful sampling is a technique widely used in qualitative research for the identification
and selection of information-rich cases for the most effective use of limited resources
(Patton, 2002). This involves identifying and selecting individuals or groups of individuals
that are especially knowledgeable about or experienced with a phenomenon of interest
(Cresswell & Plano Clark, 2011)
6. Incomplete inclusion criteria (without exclusion criteria)

● Proper definition of eligibility, inclusion, exclusion and discontinuation criteria

of the study subjects should be stated.
● Inclusion criteria:
○ Patients 19 – 40 years of age → Surgery patients? Time frame? Old or new patients?
○ Medical and non-medical staff → criteria for choosing non-medical staff
(administrative, decision makers, ancillary staff)? Medical staff only those in the
surgery department?
7. Pre-testing the questionnaire/survey

● How do you measure acceptability? (criteria) → questions per category

● Survey questionnaire: Yes/No questions (close-ended questions) → how to analyze?
● Acceptability research asks: To what extent is a new idea, program, process or
measure judged as suitable, satisfying, or attractive to program deliverers? To
program recipients? (Bowel, et al. 2010)
● Possible outcomes for acceptability studies:
○ Satisfaction
○ Intent to continue use
○ Perceived appropriateness
○ Fit within organizational culture
8. Informed consent doesn’t sufficiently provide the required elements

● Information form should contain: Justification for research, outline of study, risks,
confidentiality, and voluntary participation should be told patients about the freedom to
withdraw from the study whenever they wish to. Confidentiality indicates how the
personal information obtained from the patient will be kept secret (Data safety). (Al-jundi,
2016)
● Sample protocol → only the justification for research was mentioned
9. Wrong data analysis for the methods

● The analysis plan and which statistical tests will be used to check the significance to the
research question/hypothesis should be described. Names of variables that will be used in
the analyses and the name of statistical analysis that will be performed to assess the
outcome should be listed (Al-jundi, 2016)
● Thematic analysis instead of frequency and percentage
10. No logical framework

● No logical consistency from question to methods to expected output

● Research question (none) → Objectives (acceptability of surgical unit) → Methods (Literature
review, logbook review, interview, FGD, survey) → expected output?
○ Research question: what are the practices, perceived benefits, and barriers into having an
ambulatory surgery unit in a government hospital
○ Objective: To determine the acceptability and feasibility of an ambulatory surgery unity in a
government hospital (specific: practices, perceived benefits, barriers)
○ Methods: Qualitative Descriptive Study (KII → FGD → Survey)
○ Analysis: Thematic analysis