QUALITY OF RESEARCH

As noted in the Orientation, research already done and published in the literature was found seriously deficient in terms of adherence to conventional standards of research in clinical studies, epidemiologic studies and projects from other relevant disciplines. The most common deficiencies of published research reports on WAD found by the Task Force were:

a. Lack of clarity in statement of study purpose, research question or hypothesis.

b. Inappropriate study design to test research questions or form conclusions.

c. Lack of appropriate denominator.

d. Lack of controls or suitable reference group for comparisons.

e. Absent or unclear statement of inclusion/exclusion criteria.

f. Sources of subjects that introduce intrinsic selection biases.

g. Substantial losses to follow up resulting in potential for biased estimate of outcome frequencies and determinants.

h. Ascertainment of outcomes subject to investigator and patient reporting biases.

i. Measurement methods whose reliability and validity are not established.

j. Absent or unclear statement of interval between collision and study entry, or wide variability of interval.

k. Inappropriate statistical analysis.

l. Inadequate statistical power (small sample sizes).

The Task Force stresses that future research must avoid these and other shortcomings. The scarce resources available should be protected by subjecting research protocols to the highest rigor of peer review, preferably with international panels of scientists.