Enforcing Correct TDD Dosage in Trials

Although most of the trials did not measure or control the amount of the TDD pill taken (which in software parlance translates into a lack of attention to process conformance), we believe that the dosage ended up being variable across trials and subjects. Trials with poor or unknown constructs may not have strictly enforced TDD usage, and we believe it is highly likely that the trial participants customized the pill with a selection of ingredients rather than following the strict textbook definition of TDD. This issue poses a serious threat to drawing generalized conclusions. In the medical context, not enforcing or measuring TDD usage is analogous to failing to ensure that the patients took a pill for some treatment or not knowing which dosage the patient took. Thus, the observed effects of the TDD pill may be due to process conformance or other factors that are not adequately described or controlled. In future trials, conformance to the treatment and the control should be carefully monitored.

Regardless of the reporting quality of the TDD trials, a related question is raised: “Should the textbook definition of TDD be followed in all real-life cases?” Sometimes patients get better even with a half-sized or quarter-sized pill modified for their specific work context and personal style. Micro-level logging tools for development activity are available and can be used to investigate these issues. Such logging tools can be helpful both for controlling ...

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