Once you have selected the topic of your question and focused it with a research question, decided on the numbers of patients that you need, selected an outcomes instrument, set the time parameters of your study, and appointed a project coordinator, you should consider and formalize the logistics of the study so that it will interfere as little as possible with normal office routine. This would include:
Explore This IssueApril 2008
- When will the data be collected (before and after a treatment, prior to an encounter)?
- How often will be data be collected (every office visit, every three months, once a year)?
- Where will the data be collected (in the office, sent out by mail or e-mailed)?
- Who will analyze the data collected from the patient questionnaires (the physician, the project coordinator, etc.)?3
Any time data are collected from or about patients for research purposes, they must give informed consent to participate in that research and the investigator must obtain institutional review board (IRB) consent for the research. All procedures and consent forms must adhere to HIPAA privacy regulations. If you are not affiliated with a university, IRB review can be obtained through a hospital or an independent board such as the Western IRB (WIRB). For a superb reference, including sample patient consent forms and procedures for IRB applications, see Stone’s Conducting Clinical Research.4 It is a refreshingly pragmatic handbook/guide to every step of the process by an experienced physician researcher.
Conducting the Study
Once collected, the data should be entered to a database for easy analysis. The most familiar and commonly available is Excel™, although others such as Access™ and Paradox™ or others could be used, depending on the investigator’s preference. Data must be checked periodically for accuracy, completeness, and logic-if possible, the database should be programmed to check for values that are missing, out of the measurement range (e.g., entering 100, for an actual range of 1-10), or illogical.
Be sure to check the clinic schedule periodically to assure that all eligible patients have been included in the project. Providing office personnel with a laminated, pocket-size card printed with eligibility criteria may help. A good eye for quality control is essential to ensure the integrity of the data set.
Most database programs have the ability to conduct simple analyses of the data: means, medians, standard deviations, simple t-tests, correlations, and analysis of variance (ANOVA). Data analysis may be aggregate or patient-specific, and you would need to consider whether the data are normally distributed before determining which statistical treatment would be appropriate.