Balancing benefits and harms: the example of non-steroidal anti-inflammatory drugs

Disease modification in osteoarthritis: Are drugs the answer?

“…Trials of drugs for OA (including doxycycline) are undertaken in relatively young, relatively fit people who are not representative of those with OA in the community (23). The reality of OA is that it is a disease of older people, most of whom have other health problems in addition to their joint failure.…”

Generating Evidence From Computerized Healthcare Utilization Databases

“…The advantage is made even greater by the fact that benefits and harms of a given medicament or therapeutic strategy can be assessed on a comparable scale, thereby providing regulatory agencies and caregivers with material for a balanced decision on the net beneficial effect of a therapeutic approach when applied to the general population. 1 An example is offered by the examination, via the HCU database, of the long-term benefit and harm of statin administration in the Lombardy population, the benefit consisting of the reduction of coronary events and the harm of the reported greater risk of new onset type 2 diabetes mellitus. Over a 6-year follow-up patients with high adherence to the prescribed statin therapy showed an increased risk of developing diabetes mellitus than patients with low adherence.…”

“…[1][2][3][4] For example, in RCTs, treatments are delivered according to preselected plans that make management more rigid than the one adopted in real-life. Two, treatments are delivered in a highly controlled environment by operators with specific competence, which results into a much lower chance of mistreatment or errors.…”

Evaluating Medical Effectiveness for the California Health Benefits Review Program

“…For example, a RCT of a new nonsteroidal antiinflammatory agent conducted solely on younger populations does not provide us with the information we need about potential adverse drug events in elderly populations that have elevated incidences of comorbidities (D'Agostino and Kwan 1995; Dieppe et al 2004). Unless a health care mandate is directed solely at services for a particular subgroup, such as the childhood asthma mandate (AB 1549) or the maternity services mandates (SB 897 and SB 1555), the CHBRP medical effectiveness team must consider the impact of a proposed health care mandate on all Californians regardless of age, ethnicity, or socioeconomic status.…”

“…Furthermore, the costs of a trial skyrocket as the interventions become less standardized--a key aspect of effectiveness trials, the presence of confounding factors more common, and the length of time to assess outcomes greater. Even when RCTs focus on drugs or interventions in community settings, the patient population is often carefully selected for those most likely to benefit, avoiding both unnecessary risk and ''statistical noise'' associated with patients having potential confounding risk factors (D'Agostino and Kwan 1995; Dieppe et al 2004). Well-done RCTs thus may provide data with a high degree of internal validity, but such studies often do not have the desired high external validity or generalizability (D'Agostino and Kwan 1995;Black 1996;Victora, Habicht, and Bryce 2004).…”