%0 Journal Article %1 Maclure2007 %A Maclure, Malcolm %A Carleton, Bruce %A Schneeweiss, Sebastian %D 2007 %J Medical care %K BritishColumbia Cost-BenefitAnalysis Cyclooxygenase2Inhibitors Cyclooxygenase2Inhibitors:administration&dosa Cyclooxygenase2Inhibitors:economics DecisionMaking DrugCosts DrugEvaluation DrugEvaluation:economics DrugEvaluation:ethics DrugEvaluation:methods Humans Insurance InterprofessionalRelations NationalHealthPrograms NationalHealthPrograms:economics NationalHealthPrograms:organization&administr NationalHealthPrograms:statistics&numericald NebulizersandVaporizers NebulizersandVaporizers:economics Organizational PharmaceuticalServices PharmaceuticalServices:economics PharmaceuticalServices:statistics&numericalda PolicyMaking RandomizedControlledTrialsasTopic:economics RandomizedControlledTrialsasTopic:ethics ResearchDesign RCT %N 10 Supl 2 %P S44-9 %R 10.1097/MLR.0b013e318068932a %T Designed delays versus rigorous pragmatic trials: lower carat gold standards can produce relevant drug evaluations. %U http://www.ncbi.nlm.nih.gov/pubmed/17909382 %V 45 %X 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. %@ 0025-7079; 0025-7079

@article{Maclure2007, abstract = {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.}, added-at = {2023-02-03T11:44:35.000+0100}, author = {Maclure, Malcolm and Carleton, Bruce and Schneeweiss, Sebastian}, biburl = {https://www.bibsonomy.org/bibtex/26a5bd80918196ab866b7624a6c7ba1a6/jepcastel}, city = {School of Health Information Science, University of Victoria, Victoria, British Columbia, Canada. malcolmmaclure@shaw.ca}, doi = {10.1097/MLR.0b013e318068932a}, interhash = {3bd20ef1cfe828aa2890644e1d407911}, intrahash = {6a5bd80918196ab866b7624a6c7ba1a6}, isbn = {0025-7079; 0025-7079}, issn = {0025-7079}, journal = {Medical care}, keywords = {BritishColumbia Cost-BenefitAnalysis Cyclooxygenase2Inhibitors Cyclooxygenase2Inhibitors:administration&dosa Cyclooxygenase2Inhibitors:economics DecisionMaking DrugCosts DrugEvaluation DrugEvaluation:economics DrugEvaluation:ethics DrugEvaluation:methods Humans Insurance InterprofessionalRelations NationalHealthPrograms NationalHealthPrograms:economics NationalHealthPrograms:organization&administr NationalHealthPrograms:statistics&numericald NebulizersandVaporizers NebulizersandVaporizers:economics Organizational PharmaceuticalServices PharmaceuticalServices:economics PharmaceuticalServices:statistics&numericalda PolicyMaking RandomizedControlledTrialsasTopic:economics RandomizedControlledTrialsasTopic:ethics ResearchDesign RCT}, month = {10}, note = {6352<m:linebreak></m:linebreak>GR: AG19463/AG/NIA NIH HHS/United States; JID: 0230027; 0 (Cyclooxygenase 2 Inhibitors); ppublish;<m:linebreak></m:linebreak>CER}, number = {10 Supl 2}, pages = {S44-9}, pmid = {17909382}, timestamp = {2023-05-04T09:00:45.000+0200}, title = {Designed delays versus rigorous pragmatic trials: lower carat gold standards can produce relevant drug evaluations.}, url = {http://www.ncbi.nlm.nih.gov/pubmed/17909382}, volume = 45, year = 2007 }