Lecture 1

1. Lecture 1 Understanding the Research Process Dr Salah AbuRuz

2. The first randomized controlled trial • Medical Research Council. Streptomycin in Tuberculous Trials Committee. Streptomycin treatment of pulmonary tuberculous. BMJ 1948;ii:769–82.

3. What Is Research? • Systematic study of one or more problems, usually posed as research questions • Research methods include experiments, surveys, correlational studies, and other methods such as meta-analysis

4. What Is Statistics? • Branch of applied mathematics that deals with collecting, organizing & interpreting data using well-defined procedures in order to make decisions.

5. Purpose of Statistics • Statistical Methods provide a logical bases for making decisions in variety of setting when incomplete information is available

6. Purpose of Statistics • To describe & summarize information, thereby reducing it to smaller, more meaningful sets of data • To make predictions or to generalize about occurrences based on observations • To identify associations, relationships or differences between sets of observations

7. How can researcher test the effectiveness of a vaccine against common cold? • How effective is a trial that that seeks to reduce the risk of CAD?

8. Major Classes of Research Experimental research Researchers actively introduce an intervention or treatment Nonexperimental research Researchers collect data without intervening or introducing treatments

9. Example of nonexperimental research: Wong and her co-researchers (2002) searched for factors that contributed to hospital readmission in a Hong Kong hospital. A readmitted group was compared with a nonreadmitted group of patients in terms of demographic characteristics and health conditions upon admission.

10. Experimental studies are explicitly designed to test causal relationships. • Sometimes nonexperimental studies also seek to elucidate or detect causal relationships, but doing so is tricky and usually is less conclusive. • Experimental studies offer the possibility of greater control over extraneous variables than nonexperimental studies.

11. Phases in a Quantitative Study • Phase 1: Conceptual Phase • Phase 2: Design and Planning Phase • Phase 3: Empirical Phase • Phase 4: Analytic Phase • Phase 5: Dissemination Phase

12. Major Steps in a Quantitative Study • Phase 1: Conceptual Phase • Formulating/delimiting the problem • One of the first things a researcher must do is develop a research problem and research questions. Good research depends to a great degree on good questions.

13. Research problem An perplexing, or troubling condition • The purpose of research is to “solve” the problem—or to contribute to its solution—by accumulating relevant information. • Examples of research topics are adolescent smoking, patient compliance, coping with disability, and pain management. Within each of these broad topics are many potential research problems.

14. Sources of Research Problems • Experience and clinical fieldwork • literature • Social issues • Theory • Ideas from external sources

15. In developing a research question to be studied, researchers must pay close attention to • substantive issues (Is this research question significant, given the existing base of knowledge?); • clinical issues (Could findings from this research be useful in clinical practice?); • And methodologic issues (How can this question best be studied to yield high-quality evidence?). • The identification of research questions must also take into consideration practical and ethical concerns.

16. 2. Reviewing related literature • To build on existing theory or research, quantitative researchers strive to understand what is already known about a research problem. • a literature review sometimes precedes the delineation of the research problem.

17. 3. Undertaking clinical fieldwork • It help researchers better understand affected clients and the settings in which care is provided.

18. 4. Formulating hypotheses • A hypothesis is a statement of the researcher’s expectations about relationships between the variables under investigation. • Hypotheses, in other words, are predictions of expected outcomes; they state the relationships researchers expect to find as a result of the study.

19. Major Steps in a Quantitative Study (cont’d) • Phase 2: Design and Planning Phase In the second major phase of a quantitative research project, researchers make decisions about the methods and procedures to be used to address the research question, and plan for the actual collection of data.

20. 5. Selecting a research design 6. Developing intervention protocols 7. Identifying the population 8. Designing the sampling plan • The design of a sampling plan includes the selection of a sampling method, the specification of the sample size (i.e., number of subjects), and the development of procedures for recruiting subjects.

21. Major Steps in a Quantitative Study (cont’d) • Phase 2: Design and Planning Phase (cont’d) 9. Specifying methods to measure variables and collect data 10 Developing methods to protect human/animals rights 11. Finalizing the research plan (pilot testing or pre testing)

22. Major Steps in a Quantitative Study (cont’d) • Phase 3: Empirical Phase 12. Collecting the data 13. Preparing data for analysis (data coding and entery)

23. Major Steps in a Quantitative Study (cont’d) • Phase 4: Analytic Phase 14. Analyzing the data 15. Interpreting results

24. Major Steps in a Quantitative Study (cont’d) • Phase 5: Dissemination Phase 16. Communicating the findings 17. Utilizing findings in practice

25. Problem Statements: • A statement articulating the research problem and indicating the need for a study • Should identify the nature, context, and significance of problem being addressed • Should be broad enough to include central concerns • Should be narrow enough to serve as a guide to study design

26. Problem Statements: example • Nausea and vomiting are common side effects among patients on chemotherapy, and interventions to date have been only moderately successful in reducing these effects. New interventions that can reduce or prevent these side effects need to be identified.

27. Problem Statements: example • Aburuz et al: Identifying, preventing and resolving drug-related problems are probably the most important functions of pharmaceutical care. Classifying drug-related problems, therefore, is essential for the development of pharmaceutical care practice and important for pharmaceutical care research. Several drug-related problem classification systems can be found in the literature, however, it is generally agreed that a comprehensive, well constructed and validated instrument is currently lacking.

28. Basic Terminology (cont’d) Statement of purpose The researcher’s summary of the overall study goal Research aims or objectives The specific accomplishments to be achieved by conducting the study

29. Statements of Purpose—Quantitative Studies: • Suggest, through use of verbs, the nature of the inquiry (e.g., to test…, to compare…, to evaluate…) • Identify key study variables • Identify possible relationships among variables • Indicate the population of interest

30. Statement of purpose: The purpose of the study is to test an intervention to reduce chemotherapy-induced side effects—specifically, to compare the effectiveness of patient-controlled and pharmacist administered antiemetic therapy for controlling nausea and vomiting in patients on chemotherapy.

31. Aims/objectives This study has as its aim the following objectives: • to develop and implement two alternative procedures for administering antiemetic therapy for patients receiving moderate emetogenic chemotherapy (patient controlled versus pharmacist controlled); (2) to test three hypotheses concerning the relative effectiveness of the alternative procedures on medication consumption and control of side effects; and (3) to use the findings to develop recommendations for possible changes to therapeutic procedures.

32. The aim of this study is the development and validation of a comprehensive treatment-related problems assessment and classification tool for use in teaching, practicing and researching pharmaceutical care

33. Basic Terminology (cont’d) Research questions The specific queries the researcher wants to answer in addressing the research problem Hypotheses The researcher’s predictions about relationships among variables

34. Research Questions: • Are sometimes direct rewordings of statements of purpose, worded as questions • Are sometimes used to clarify or lend specificity to the purpose statement • In quantitative studies, pose queries about the relationships among variables

35. Research question: What is the relative effectiveness of patient-controlled antiemetic therapy versus pharmacist controlled antiemetic therapy with regard to (a) medication consumption and (b) control of nausea and vomiting in patients on chemotherapy?

36. A Hypothesis: • States a prediction • Must always involve at least 2 variables • Must suggest a predicted relationship between the independent variable and the dependent variable • Must contain terms that indicate a relationship (e.g., more than, different from, associated with)

37. The research question identifies the concepts under investigation and asks how the concepts might be related; a hypothesis is the predicted answer. • For example, the initial research question might be phrased as follows: Is preeclamptic toxemia in pregnant women associated with stress factors present during pregnancy? • This might be translated into the following hypothesis: Pregnant women with a higher incidence of stressful events during pregnancy will be more likely than women with a lower incidence of stress to experience preeclamptic toxemia. Most quantitative studies are designed to test hypotheses through statistical analysis.

38. Hypotheses (1) Subjects receiving antiemetic therapy by a patient-controlled pump will report less nausea than subjects receiving the therapy by pharmacist administration; (2) subjects receiving antiemetic therapy by a patient-controlled pump will vomit less than subjects receiving the therapy by pharmacist administration; (3) Subjects receiving antiemetic therapy by a patient-controlled pump will consume less medication than subjects receiving the therapy by pharmacist administration.

39. Function of Hypothesis • The development of predictions in and of itself forces researchers to think logically, to exercise critical judgment, and to tie together earlier research findings. • The use of hypotheses in quantitative studies tends to induce critical thinking and to facilitate understanding and interpretation of the data. • The failure of data to support a prediction forces researchers to analyze theory or previous research critically, to carefully review the limitations of the study’s methods, and to explore alternative explanations for the findings.

40. To illustrate further the utility of hypotheses, suppose we conducted the study guided only by the research question. The investigator without a hypothesis is, apparently, prepared to accept any results. The problem is that it is almost always possible to explain something superficially after the fact, no matter what the findings are. Hypotheses guard against superficiality and minimize the possibility that spurious results will be misconstrued.

41. Example • Statement of Purpose: The purpose of this study was to explore the relationship between method of pain management during labor and specific labor and birth outcomes.

42. Example Research Questions: (1) Are nonepidural and epidural methods of pain relief associated with augmentation during the first stage of labor? (2) Is the length of second stage labor associated with epidural and nonepidural methods of pain relief? (3) Are newborn Apgar scores at 1 minute and 5 minutes associated with method of pain relief? (4) Does epidural anesthesia affect maternal temperature? (Walker & O’Brien, 1999)

43. Example • The homeless in the United States continue to increase in • numbers and in diversity.... An estimated 760,000 people • experience homelessness at some time during a one-year • period.... Women and families make up the fastest-growing • segment of the homeless population, and women head an estimated • 90% of homeless families. The purpose of this study • was to compare the characteristics of families of origin of • homeless women with the families of origin of neverhomeless • women whose childhood experiences placed them • at risk for homelessness (Anderson & Imle, 2001, p. 394)

44. Home work 1 • Identify from the literature: • Research problem • Statement of purpose • Research question • Research hypothesis • Write your own