Sample Excerpt: Due Diligence

Sample Paper Excerpt

The study objective of a collaborative behavioral intervention was to increase compliance to a medical regimen among tuberculosis patients. There were three educational interventions and a control group. The protocol specified using a 'systematic' sampling procedure to recruit patients being treated for tuberculosis in a public health clinic. Systematic sampling is the sampling procedure wherein the kth element of the population under study is selected for the sample, with the starting point randomly determined from the first k elements (Sampling Theory, 2006).

Following completion of the intervention, the principal investigator/lead author assigns herself the task of writing the Introduction, Literature Review, and Discussion sections. The co-principal investigator is assigned to work on the Methods and Analysis sections. This co-principal investigator had been responsible for developing, implementing, and monitoring the sampling procedure for subject recruitment and other data collection activities.

In the Conclusion portion of the manuscript, the lead author describes the relative efficacy of the different interventions, making inferences about applying them to similar patient populations:

"The combination educational intervention and incentives had the highest level of patient compliance compared to the other interventions or the control group."

However, prior to submitting the manuscript, the principal investigator discovers that the research staff did not follow the designated systematic sampling procedure, relying instead on a 'convenience' sample. The failure of the co-principal investigator to monitor recruitment activities lead to a violation of the study protocol.

Are the study results still valid?

No statistical test produces valid results if the sampling was done incorrectly.
Since all of the patients were recruited in the same manner (all through a convenience sample) the inferences are still valid.
The results are still valid it the data is analyzed with an alternative analytic tool.
Since the lead author was not responsible for monitoring data collection activities, the inferences remain valid.

Proceed to the

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