Longitudinal observational studies to study the efficacy-effectiveness gap in drug therapy: application to mild and moderate dementia.
If well-designed, longitudinal observational studies (LOSs) can provide insights to the linkages between real-world outcomes and their multilevel determinants. In this article, some of the scientific and methodologic issues related to LOSs in pharmacotherapeutic evaluations are discussed. A case of such a study in the treatment of mild to moderate dementia is provided-a case in which a pharmaceutic sponsor addressing a medical question (long-term effectiveness) realized that caring for patients who have Alzheimer's disease involves the clinical community of caregivers, physicians, families, nurses, psychologists, and pharmacists, among others, and partnered with nurse researchers to design their inquiry. The authors conclude by presenting an argument for nurses to take the lead in effectiveness research.
MacDonald
Karen M
KM
Matrix45, LLC 620 Frays Ridge Road, Earlysville, VA 22936, USA. kmacdonald@matrix45.com
Vancayzeele
Stefaan
S
Deblander
Anne
A
Abraham
Ivo L
IL
D000368:Aged; D001294:Attitude to Health; D001530:Belgium / Q000453:epidemiology; D017028:Caregivers / Q000523:psychology; D002800:Cholinesterase Inhibitors / Q000494:pharmacology / Q000627:therapeutic use*; D017281:Cost of Illness; D003704:Dementia / Q000145:classification / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D004363:Drug Utilization / Q000706:statistics & numerical data; D019317:Evidence-Based Medicine / Q000458:organization & administration; D005190:Family / Q000523:psychology; D015577:Geriatric Assessment; D005851:Geriatric Nursing / Q000458:organization & administration; D006801:Humans; D008137:Longitudinal Studies; D024802:Nurse's Role; D019370:Observation; D017063:Outcome Assessment, Health Care; D017891:Pharmacoepidemiology / Q000458:organization & administration*; D048448:Phenylcarbamates / Q000494:pharmacology / Q000627:therapeutic use*; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D012107:Research Design; D000068836:Rivastigmine; D012720:Severity of Illness Index
D002800:Cholinesterase Inhibitors; D048448:Phenylcarbamates; D000068836:Rivastigmine