Wim Marneffe

Barriers and facilitators related to the implementation of surgical safety checklists: a systematic review of the qualitative evidence

Objective The objective of this review is to obtain a better understanding of the user-related barriers against, and facilitators for, the implementation of surgical safety checklists. Methods We searched MEDLINE for articles describing stakeholders’ perspectives regarding, and experiences with, the implementation of surgical safety checklists. The quality of the papers was assessed by means of the Qualitative Assessment and Review Instrument. Thematic synthesis was used to integrate the emergent descriptive themes into overall analytical themes. Results The synthesis of 18 qualitative studies indicated that implementation requires change in the workflow of healthcare professionals as well as in their perception of the checklist and the perception of patient safety in general. The factors impeding or advancing the required change concentrated around the checklist, the implementation process and the local context. We found that the required safety checks disrupt operating theatre staffs’ routines. Furthermore, conflicting priorities and different perspectives and motives of stakeholders complicate checklist implementation. When approaching the checklist as a simple technical intervention, the expectation of cooperation between surgeons, anaesthetists and nurses is often not addressed, reducing the checklist to a tick-off exercise. Conclusions The complex reality in which the checklist needs to be implemented requires an approach that includes more than eliminating barriers and supporting facilitating factors. Implementation leaders must facilitate team learning to foster the mutual understanding of perspectives and motivations, and the realignment of routines. This paper provides a pragmatic overview of the user-related barriers and facilitators upon which theories, hypothesising potential change strategies and interactions, can be developed and tested empirically.

Does lean management improve patient safety culture? An extensive evaluation of safety culture in a radiotherapy institute

PURPOSE The importance of a safety culture to maximize safety is no longer questioned. However, achieving sustainable culture improvements are less evident. Evidence is growing for a multifaceted approach, where multiple safety interventions are combined. Lean management is such an integral approach to improve safety, quality and efficiency and therefore, could be expected to improve the safety culture. This paper presents the effects of lean management activities on the patient safety culture in a radiotherapy institute. METHODS Patient safety culture was evaluated over a three year period using triangulation of methodologies. Two surveys were distributed three times, workshops were performed twice, data from an incident reporting system (IRS) was monitored and results were explored using structured interviews with professionals. Averages, chi-square, logistical and multi-level regression were used for analysis. RESULTS The workshops showed no changes in safety culture, whereas the surveys showed improvements on six out of twelve dimensions of safety climate. The intention to report incidents not reaching patient-level decreased in accordance with the decreasing number of reports in the IRS. However, the intention to take action in order to prevent future incidents improved (factorial survey presented β: 1.19 with p: 0.01). CONCLUSIONS Due to increased problem solving and improvements in equipment, the number of incidents decreased. Although the intention to report incidents not reaching patient-level decreased, employees experienced sustained safety awareness and an increased intention to structurally improve. The patient safety culture improved due to the lean activities combined with an organizational restructure, and actual patient safety outcomes might have improved as well.

An Empirical Analysis of Case Disposition Time in Belgium

Abstract This paper analyzes the determinants of case disposition times in Belgian first instance courts by exploiting a unique dataset of 174 court cases. Unlike previous studies, our analysis focuses mainly on case-level determinants. Regression results show that the use of expert assessments on average prolongs overall disposition time by 902 days. Furthermore, the number of pleadings, as a proxy of case complexity, also significantly impacts the duration of trials. Additionally, results indicate that case outcomes, such as settlements or plaintiff wins, are significant determinants of case duration. In addition to case-level characteristics, our results indicate that two civil procedure reforms aimed at accelerating adjudication led to a major decrease of case duration in Belgian first instance courts.

Does Compliance to Patient Safety Tasks Improve and Sustain when Radiotherapy Treatment Processes are Standardized

PURPOSE To realize safe radiotherapy treatment, processes must be stabilized. Standard operating procedures (SOPs) were expected to stabilize the treatment process and perceived task importance would increase sustainability in compliance. This paper presents the effects on compliance to safety related tasks of a process redesign based on lean principles. METHOD Compliance to patient safety tasks was measured by video recording of actual radiation treatment, before (T0), directly after (T1) and 1.5 years after (T2) a process redesign. Additionally, technologists were surveyed on perceived task importance and reported incidents were collected for three half-year periods between 2007 and 2009. RESULTS Compliance to four out of eleven tasks increased at T1, of which improvements on three sustained (T2). Perceived importance of tasks strongly correlated (0.82) to compliance rates at T2. The two tasks, perceived as least important, presented low base-line compliance, improved (T1), but relapsed at T2. The reported near misses (patient-level not reached) on accelerators increased (P < 0.001) from 144 (2007) to 535 (2009), while the reported misses (patient-level reached) remained constant. CONCLUSIONS Compliance to specific tasks increased after introducing SOPs and improvements sustained after 1.5 years, indicating increased stability. Perceived importance of tasks correlated positively to compliance and sustainability. Raising the perception of task importance is thus crucial to increase compliance. The redesign resulted in increased willingness to report incidents, creating opportunities for patient safety improvement in radiotherapy treatment.

Cost–effectiveness of gemcitabine versus PEGylated liposomal doxorubicin for recurrent or progressive ovarian cancer: comparing chemotherapy with nanotherapy

This article examines the cost-effectiveness of chemotherapy (gemcitabine) versus nanotherapy (PEGylated liposomal doxorubicin) in the treatment of ovarian cancer. Significant differences in costs were mainly due to the initial drug costs, which were €1285.28 in favor of chemotherapy. These costs were more than offset by hospitalization costs, which were €2670.21 in favor of the nanotherapy. The cost per quality-adjusted life week (QALW) for the nanotherapy was estimated to be €220.92/QALW for the base case and ranged from €170-318/QALW based on model assumptions. The clinical benefit associated with nanotherapy was achieved, yielding not only positive cost-effectiveness results, but also, surprisingly, financial savings. Although more studies are necessary, this first comprehensive analysis supports the further use of nanotherapy for ovarian cancer.

Assessing the need for quality-adjusted cost–effectiveness studies of nanotechnological cancer therapies

New therapies, such as nanotechnology-based cancer treatments, typically entail high acquisition costs. Their use can be justified, however, by their superior cost-effectiveness. This article assesses the quality of cost-effectiveness analyses of nanotechnological cancer therapies by screening nine major studies. They conclude that nanotherapies are cost effective for the treatment of ovarian and breast cancer, as well as multiple myeloma, but not for other types of cancer. However, these studies have some serious methodological flaws. Typically, the results are not quality adjusted, although both length and quality of life are affected. Moreover, only fragmented direct medical costs are included, neglecting indirect costs that impose a significant economic burden on patients and society. Finally, cost definitions differ widely making any comparison between studies virtually impossible. This article concludes that economic research of nanotechnology-based therapeutics is still in its infancy. It warns that incomplete economic analysis may lead to inefficient policy recommendations.

The effects of a lean transition on process times, patients and employees.

Purpose Treatment delays must be avoided, especially in oncology, to assure sustainable high-quality health care and increase the odds of survival. The purpose of this paper is to hypothesize that waiting times would decrease and patients and employees would benefit, when specific lean interventions are incorporated in an organizational improvement approach. Design/methodology/approach In 2013, 15 lean interventions were initiated to improve flow in a single radiotherapy institute. Process/waiting times, patient satisfaction, safety, employee satisfaction, and absenteeism were evaluated using a mixed methods methodology (2010-2014). Data from databases, surveys, and interviews were analyzed by time series analysis, χ2, multi-level regression, and t-tests. Findings Median waiting/process times improved from 20.2 days in 2012 to 16.3 days in 2014 ( p<0.001). The percentage of palliative patients for which waiting times had exceeded Dutch national norms (ten days) improved from 35 (six months in 2012: pre-intervention) to 16 percent (six months in 2013-2014: post-intervention; p<0.01), and the percentage exceeding national objectives (seven days) from 22 to 17 percent ( p=0.44). For curative patients, exceeding of norms (28 days) improved from 17 (2012) to 8 percent (2013-2014: p=0.05), and for the objectives (21 days) from 18 to 10 percent ( p<0.01). Reported safety incidents decreased 47 percent from 2009 to 2014, whereas safety culture, awareness, and intention to solve problems improved. Employee satisfaction improved slightly, and absenteeism decreased from 4.6 (2010) to 2.7 percent (2014; p<0.001). Originality/value Combining specific lean interventions with an organizational improvement approach improved waiting times, patient safety, employee satisfaction, and absenteeism on the short term. Continuing evaluation of effects should study the improvements sustainability.

Safer radiation therapy treatment resulting from an equipment transition: A mixed-methods study.

PURPOSE To realize individualized safe radiation therapy, reliable treatment equipment is essential in combination with a system-level improvement approach. We hypothesized that implementation of a system that integrated all required treatment equipment would result in improved safety and stability of the irradiation treatment process. METHODS AND MATERIALS Seven accelerators, portal imaging, and the treatment planning software were replaced by an integrated system that included 6 accelerators. The number of reported safety incidents and root causes were recorded between 2010 and 2014. Time series analysis was performed, and quantitative results were explored by structured interviews. Additionally, downtime was recorded. RESULTS From January 2010 to July 2014, 5085 incidents were reported. Reports related to the accelerators decreased from 33% (2010) to 20% (2013-2014) of total reports, whereas the number of delivered fractions per accelerator increased by 20% (2010: 643 per month; 2013: 795 per month). Reports related to portal imaging decreased from 16.5 reports per month (2010) to 3.1 (2013-2014). Of these portal imaging reports, 316 had at least 1 technical cause in 2010, which decreased to 13 in 2013-2014. Interviewees attributed the decreased reporting to the equipment transition, not to decreased safety awareness. Downtime decreased by 46%, from 5.4% in 2010 to 2.9% in 2013. CONCLUSIONS The number of reported accelerator- and portal imaging-related incidents decreased significantly, whereas safety awareness remained stable. In addition, accelerator downtime decreased, possibly resulting in less rescheduling of patients and fewer disruptions of work processes. Therefore, we conclude that the risk for serious safety incidents and patient harm decreased after implementation of the new integrated system.

Has Lean improved organizational decision making

Purpose - Sustainable improvement is likely to be hampered by ambiguous objectives and uncertain cause-effect relations in care processes (the organizations decision-making context). Lean management can improve implementation results because it decreases ambiguity and uncertainties. But does it succeed? Many quality improvement (QI) initiatives are appropriate improvement strategies in organizational contexts characterized by low ambiguity and uncertainty. However, most care settings do not fit this context. The purpose of this paper is to investigate whether a Lean-inspired change program changed the organizations decision-making context, making it more amenable for QI initiatives. Design/methodology/approach - In 2014, 12 professionals from a Dutch radiotherapy institute were interviewed regarding their perceptions of a Lean program in their organization and the perceived ambiguous objectives and uncertain cause-effect relations in their clinical processes. A survey (25 questions), addressing the same concepts, was conducted among the interviewees in 2011 and 2014. The structured interviews were analyzed using a deductive approach. Quantitative data were analyzed using appropriate statistics. Findings - Interviewees experienced improved shared visions and the number of uncertain cause-effect relations decreased. Overall, more positive (99) than negative Lean effects (18) were expressed. The surveys revealed enhanced process predictability and standardization, and improved shared visions. Practical implications - Lean implementation has shown to lead to greater transparency and increased shared visions. Originality/value - Lean management decreased ambiguous objectives and reduced uncertainties in clinical process cause-effect relations. Therefore, decision making benefitted from Lean increasing QIs sustainability.

A Conceptual Framework on the Impact of Regulatory Quality on Litigation

Abstract In the research fields of both law and economics, literature on the quality of regulation has gained importance in recent years. Particularly, the economic effect of sound business regulation has been examined. However, almost no research exists on the effect of regulatory quality on litigation and court delay. Therefore, this article examines the latter relationship by developing a conceptual framework, which states that lower regulatory quality: (i) stimulates the recourse to justice and (ii) increases case disposition time by impeding the judges and lawyers’ work. Both effects in turn increase backlogs in the courts. Furthermore, this article provides empirical evidence that confirms the hypothesized inverse relationship between litigation and regulatory quality.