Designed delays versus rigorous pragmatic trials: lower carat gold standards can produce relevant drug evaluations

Med Care. 2007 Oct;45(10 Supl 2):S44-9. doi: 10.1097/MLR.0b013e318068932a.


Background: Centralized administrative databases enable low-cost pragmatic randomized trials (PRTs) of drug effectiveness and safety. We simplified the PRT strategy by using designed delays (DD) to evaluate drug policies.

Objectives: To reassess our DD trial of a cost-saving nebulizer-to-inhaler conversion policy and a proposed DD trial of reduced restrictions on Cox-2 inhibitors.

Research design: We randomized 52 pairs of communities and clusters of physician practices to the policy either on time or after a 6-month delay. Our 2-stage qualitative reassessment comprised: (1) applying criteria for reporting PRTs and (2) assessing DD trials in 3 domains of responsibility: policymakers' decisions, researchers' decisions, and joint decisions involving negotiation.

Measures: A draft checklist of 22 Consolidated Standards of Reporting Trials (CONSORT). Researchers' recollections of their degree of influence on decisions.

Results: DD trials deviated from ideal PRTs in the policymakers' domain: the policies affected mixtures of drugs, users, and illnesses, and implementation was not by strict protocol. Aspects negotiated by researchers and policymakers also deviated from ideal: length of delay; size and location of control group; unit of randomization; additional data collection; and communications to physicians. The DD trials complied better with CONSORT in the researchers' domain of analysis and interpretation.

Conclusions: DD trials can be negotiated with policymakers. Low cost and simplicity of DD trials partly compensate for some limitations for evaluating drug safety and effectiveness. The ethics question of whether a DD is routine evaluation or research depends on its purpose and generalizability.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • British Columbia
  • Cost-Benefit Analysis
  • Cyclooxygenase 2 Inhibitors / administration & dosage
  • Cyclooxygenase 2 Inhibitors / economics
  • Decision Making, Organizational
  • Drug Costs
  • Drug Evaluation / economics
  • Drug Evaluation / ethics
  • Drug Evaluation / methods*
  • Humans
  • Insurance, Pharmaceutical Services* / economics
  • Insurance, Pharmaceutical Services* / statistics & numerical data
  • Interprofessional Relations
  • National Health Programs / economics
  • National Health Programs / organization & administration
  • National Health Programs / statistics & numerical data
  • Nebulizers and Vaporizers / economics
  • Policy Making*
  • Randomized Controlled Trials as Topic / economics
  • Randomized Controlled Trials as Topic / ethics
  • Randomized Controlled Trials as Topic / methods*
  • Research Design*


  • Cyclooxygenase 2 Inhibitors