Safety outcomes

Eikelboom, J.W., Mehta, S.R., Pogue, J. and Yusuf, S. (2001). Safety Outcomes in Metaanalyses of Phase II versus Phase III Randomized Trials. JAMA 285 444-450. 

A DMC will generally review data related to the conduct of the study (that is, the quality of the study and its ultimate ability to address the scientific questions of interest), in addition to data on effectiveness and safety outcomes. These data may include, among other items ... 

Test products were well tolerated with infrequent and minor adverse events. With regard to safety outcomes, hematologies and serum chemistries tracked throughout the intervention within two standard deviations of baseline values. 

A process safety program must be relevant to the company and its operations. The program must also be relevant to employees personal safety and success. The link between safety actions and safety outcomes is most obvious in operations that directly handle highly hazardous materials. Unfortunately, that nexus may not be as obvious in the systems that support and are otherwise indirectly associated with hazardous materials. Appropriately developed, implemented, and communicated process safety metrics can help educate personnel on the importance of different aspects of the process safety system. 

Percentage of Duration Above a Certain Predefined Grade of an Adverse Event A New Metric for Characterizing a Safety Outcome... 

Are there any covariates that influence the pharmacodynamics (i.e., the safety) outcome ... 

Based on the positive efficacy and safety outcomes of the pre-clinical studies (see Section 6.4), a clinical program was initiated in 1998 to determine whether the improvement in cardiac perfusion and function (without any product-related adverse effects) detected in animals translates into clinical therapeutic benefit in patients with chronic stable angina. Two studies, the Angiogenic Gene Therapy (AGENT) trial and AGENT 2, involving a total of 131 patients followed for 12 months, have been completed [13, 14]. 

Lynch TJ et al. Preliminary treatment patterns and safety outcomes for non-small cell lung cancer (NSCLQ from ARIES, a bevadzumab treatment observational cohort study (OCS). Journal of Clinical Oncology (Meeting Abstracts) 2008 26 8077. 

Trust plays a central role in safety (Conchie et al. 2006). Studies have shown links between positive safety outcomes, and tmst in management (e.g., DePasquale and Geller 1999 Kath et al. 2010 Luria 2010), and tmst in co-workers (e.g., Tharaldsen et al. 2010). Tmst is also a key aspect of a positive safety culture (Bums et al. 2006), influences safety attitudes (Walker 2013), and influences the effectiveness of risk communication (Conchie and Bums 2008 Twyman et al. 2008). While there are clear safety benefits associated with tmst, safety benefits can also come from distmst (Conchie and Donald 2008), and this is likely to particularly be the case in relation to new employees in their initial period of employment. Tmst can reduce an... 

Another psychological benefit for w orkers of having meaningful involvement in planning the firm s safety policy is that they begin to take ownership of safety outcomes, increasing their commitment to the program s successful implementation. This would also be expected to improve safety. 

We measure this participation effect both through a numerical count of the t5 es of decision-making activities the firm allows its workers to participate in (the extensive participation margin) and the degree of participation in those activities (the intensive participation margin). We expect greater involvement in either dimension will improve safety outcomes. 

While Eaton and Nocerino (2000) find the existence of safety committees associated with higher injury claim rates, they also find that greater worker involvement in safety committees leads to better safety outcomes. This is consistent with our expectations concerning employee decision making, including both the number of dimensions (decision making, financial returns, and safety process) that woikers participate in and the degree of that participation. 

Involving workers in the firm s financial returns also increases workers willingness to provide information concerning effective changes in HRM policy and practice. To the extent that this increases the returns to safety investments, or lowers the costs of safety investments, accidents will fall. The demand for safety outcomes may also increase if participation in financial returns increases workers wealth and thus lowers their willingness to bear workplace risk. 

Finally, participation in financial returns may be ineffective in lowering workplace safety costs because of the free rider problem if each worker perceives that his contribution to firm safety is negligible and if safety maintenance is costly, he will let others take care while he does not. But to the extent that others feel this way, no one takes care, and the effects of employee participation on safety outcomes will be muted. Employees will ride for free by benefiting from the system without contributing to it. For example, workers with lower back pain might not file a claim if they thought they would bear the full costs of the claim. But if they were to realize that they would gain the full benefits but share (indirectly) in only a fraction of the costs, they would file. So if the extent of ownership is too small to overcome the free rider problem, moral... 

An increase in management safety culture should have the same impact on safety outcomes as an increase in worker participation in safety decision making, for similar reasons as more management resources are employed toward integrating safety within overall corporate strategy—and as more ways are foimd to minimize post-injury retum-to-work hurdles—accident costs will be reduced. To the extent this happens, the returns to safety investments increase, the level of job safety rises, and time away from work because of injuries falls. Higher values... 

Biomarkers Some products may have identified biomarkers that impact the response to treatment. If biomarkers are being considered for safety assessment, methods to investigate the relationship among treatments, biomarkers, and safety outcomes could be described. 

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