Outcome Measures Reported in Published Clinical Research Studies in Craniosynostosis: A Systematic Review.

CONTEXT: The fair comparison of treatment interventions for craniosynostosis across different studies is expected to be impaired by incomplete reporting and the use of inconsistent outcomes. OBJECTIVE: This review assessed the outcomes currently reported in studies of craniosynostosis, and whether these outcomes are formally defined and prespecified in the study methods. DATA SOURCES, SEARCH TERMS, AND STUDY SELECTION: Studies were sourced via an electronic, multi-database literature search for "craniosynostosis." All primary, interventional research studies published from 2011 to 2015 were reviewed. DATA EXTRACTION: Two independent researchers assessed each study for inclusion and performed the data extraction. For each study, data were extracted on the individual outcomes reported, and whether these outcomes were defined and prespecified in the methods. DATA SYNTHESIS AND RESULTS: Of 1027 studies screened, 240 were included and proceeded to data extraction. These studies included 18,365 patients.2192 separate outcomes were reported. Of these, 851 outcomes (38.8%) were clearly defined, 1394 (63.6%) were prespecified in the study methods."Clinical and functional" was the most commonly reported outcome theme (900 outcomes, 41.1%), and "patient-reported" outcomes the least (7 outcomes, 0.3%)."Duration of surgery" was the most commonly reported single outcome (reported 80 times). "Cranial index" was the most variably defined outcome (18 different definitions used). CONCLUSION: The outcomes reported following treatment interventions for craniosynostosis are incompletely and variably defined. Improving definitions for these outcomes may aid comparison of different management strategies and improve craniosynostosis care. Suboptimal prespecification of these outcomes in the study methods implied that outcome reporting bias cannot be excluded.

A risk management approach to the design of contraceptive implants.

This article assesses the risks associated with the insertion and removal of contraceptive implants. Risks to patient safety relate to the way the insertion device is designed and used, rather than to the pharmacological properties of the implant itself. Risks associated with removal are not amenable to thoughtful design. A systems approach is taken, the assumption being that human errors are symptoms of underlying systems deficiencies rather than causes of adverse events. The insertion procedure is broken down into five key steps. Errors in these steps contribute to non-insertion and deep insertion of implants. The design of the Implanon(®) applicator is critically examined and suggestions made as to how it could be improved in such a way as to reduce errors in its use. The exercise undertaken has coincided with the imminent launch of the redesigned applicator of the new contraceptive implant, Nexplanon(®). Preliminary comments are made about the new features of Nexplanon.

Hassle in the dispensary: pilot study of a proactive risk monitoring tool for organisational learning based on narratives and staff perceptions.

AIM To prototype a system for identifying and monitoring those organisational processes that give rise to latent conditions that can contribute to failures in a dispensary environment. METHODS A proactive risk-monitoring system was prototyped during a 9-month period within the dispensary at Hereford Hospital. The system is used to identify empirically a preliminary set of Basic Problem Factors through qualitative analysis of narratives submitted by pharmacy staff about problems they encountered during their daily work. These factors are monitored and rated based on staff perceptions elicited through a questionnaire. At the concept stage, the system idea was discussed at two stakeholder workshops to ensure plausibility. A Plan-Do-Study-Act approach was used to prototype the system and to evaluate the perceived usability and perceived completeness of the system. RESULTS After four Plan-Do-Study-Act cycles, staff were satisfied with the usability of the questionnaire and the choice of factors being monitored. In total, 11 Basic Problem Factors were identified from the narratives, 10 of which have been monitored over a period of 6 months using a questionnaire. The differences in staff perceptions were statistically not significant. The qualitative and quantitative results led to improvements that included a review of all IT equipment in the department and the clean-up of the work environment. CONCLUSION A system for identifying and monitoring organisational processes that give rise to latent conditions that may contribute to failures was prototyped at the dispensary at Hereford Hospital. This contributes to the organisation's efforts towards creating a proactive safety culture.