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Malaysian Family Physician, a peer-reviewed journal of family practice and primary care research.

Current Issue - 2006, Volume 1 Number 1

RESEARCH NOTES

WHAT STUDY DESIGN SHOULD I CHOOSE?

as observational studies7 (Box 2). In observational study, the researcher attempts to record events as they have occurred, there is no attempt to modify the frequency of their occurrence. Case-control study and cohort study are technically more complicated to perform but allow more sophisticated analysis.  Advice from experienced researchers or statistician is often needed before you embark on these studies. Furthermore, all the confounding variables need to be considered and taken into account. Of course, observational study may not be as complicated as we make it out to be. In fact, McWhinney and Glasziou have emphasized that observational study should be the mainstay of the research methods of family physicians.7-10

CLINICAL TRIAL
Your previous observational studies have verified that diabetic patients who frequently default their follow-up have high chance of being hospitalised for their diabetic complications. As hospitalisation is a costly health care burden, you think that reducing non-attendance (default) of diabetic follow-up will make a difference. Your previous cross-sectional study found that 50% of your diabetic patients did not turn up for their follow-up and the most important reason is forgetfulness! Therefore you wish to test the idea of sending out reminders to these patients a few days before their follow-up to see if those who receive the reminders are more likely to turn up. Clinical trial is an example of an experimental study whereby the researcher attempts to modify the outcome by introducing one or more interventions.11-12 The ideal clinical trial is called randomised controlled trial (RCTs) (Box 3). Conducting a clinical trial is a serious undertaking; one of the most important reasons is the potential harm that may befall the research subjects (depending on whether they are in the intervention or the control group). Lots of background data will have to be collected in the form of qualitative or observational studies before you can plan your RCT.

Box 3. Clinical trial

 Experimental studies involve attempt to change a variable in one or more groups of people. A randomised controlled trial (RCT) is commonly used to study a new preventive or therapeutic regiment. Subjects in the study population are randomly allocated to either the intervention or control groups. The results are assessed by comparing the outcome among the various groups. A good example would be to carry out a clinical intervention such as a drug trial. In this respect, detailed attention to ethical consideration is particularly important.

In a locally conducted RCT (personal communication, Leong KC), the researchers compared the effectiveness of three reminder methods (SMS, telephone, no reminder) in reducing default in general practice follow-up. Patients who required follow-up in general practice were assigned to receive any of the three interventions. Their attendance during the appointment date was track to determine whether they have defaulted.

CONCLUSION
In this article, we have illustrated a few research methods using a common clinical problem as an example. You can see that the choice of research design depends a great deal on the research questions you have identified (see Table 1). It is important to have a clear research question, so that you can plan your research properly. Only then your question can be answered.

Research questions Method
Why do patients on tuberculosis treatment default?
What is the prevalence of default among those on anti-TB treatment?
Is fear of side effects of TB drugs the cause of non-attendance?”
Does involvement of family members reduce non-attendance?” (RCT)

Qualitative – interview or FGD
Cross-sectional non-experimental study
Case-control,  cohort

Randomised controlled trial

Does reminder or patient education increase number of patients doing pap smear?
Why female patients do not do their regular pap smears?
What are their feelings towards pap smears?
What are the characteristics of patients that do not want to do pap smear?

Qualitative – interview or  FGD

Qualitative – interview or FGD
Cross-sectional

Randomised controlled trial

REFERENCE

  1. Waller J, Hodgkin P. Defaulters in general practice: who are they and what can be done about them? Fam Pract. 2000 Jun;17(3):252-3 [PubMed] [Full text]
  2. Weingarten N, Meyer DL, Schneid JA. Failed appointments in residency practices: who misses them and what providers are most affected? J Am Board Fam Pract. 1997 Nov-Dec;10(6):407-11 [PubMed]
  3. Hamilton W, Round A, Sharp D. Patient, hospital, and general practitioner characteristics associated with non-attendance: a cohort study. Br J Gen Pract. 2002 Apr;52(477):317-9 [PubMed]
  4. Bradley C. Qualitative vs quantitative research methods. In: Carter Y, Thomas C. Research Methods in Primary Care, Oxford and New York: Radcliffe Medical Press. 1999;31-37 [Link]
  5. Ross L. Qualitative research methods – data collection and analysis. In: Carter Y, Thomas C. Research Methods in Primary Care, Oxford and New York: Radcliffe Medical Press. 1999;39-47 [Link]
  6. Piterman L. Methodological/ethical issues and general practice research. Aust Fam Physician. 2000 Sep;29(9):890-1 [PubMed][Full text]
  7. Glasziou P. The importance of prognostic research. Aust Fam Physician. 2002 Nov;31(11):1035 [PubMed] [Full text]
  8. McWhinney IR. The value of case studies. Eur J Gen Pract. 2001;7:88-9 [Link]
  9. McWhinney IR. Why are we doing so little clinical research? Part 1: Clinical descriptive research. Can Fam Physician. 2001 Sep;47:1701-5. [PubMed] [Full text]
  10. McWhinney IR. Why are we doing so little clinical research? Part 2: Why clinical research is neglected. Can Fam Physician. 2001 Oct;47:1944-55 [PubMed] [Full text]
  11. Steven I. Intervention trials in general practice. Aust Fam Physician. 1998 Jul;27(7):605-7 [PubMed]
  12. Wilson S, Delaney BC, Roalfe A, et al. Randomised controlled trials in primary care: case study. BMJ. 2000 Jul 1;321(7252):24-7 [PubMed] [Full text]

Address for correspondence: Dr Zailinawati Abu Hassan, Klinik Keluarga, No 2-1, Jalan 1A/ 27A, Section 1, Wangsa Maju, 53000, Kuala Lumpur, Malaysia. Email address: zailina@nasioncom.net

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