Perla Jacqueline Marang-Van de Mheen

Ten years ago, Safety-II was introduced as a new approach to safety and contrasted with the existing approach (Safety-I), which emphasized learning from work as done in practice and the adaptive capacity of professionals who manage to deliver safe care in challenging circumstances. While Safety-II was presented as a complementary view of safety, it remained unclear how the 2 approaches would complement each other in daily practice. The aim of this paper is to reexamine the Safety-I and II distinction, look beneath the 2 labels to understand what complementary safety approaches can be distilled and how and when each safety approach might be used in practice. The Safety-I and II labels do not clearly convey the critical distinction between safety approaches, which may be part of why implementation in practice has been challenging. We suggest that the critical distinction is between “designing hazards out of the system” versus “relying on adaptability and resilience of the system,” which does not equate to Safety-I and II. This distinction makes it clearer when each approach should be used in practice, that is, in normal circumstances or when dealing with unexpected disruptions, and how well-known safety strategies fit either approach. We should focus on designing systems that support human work while also enabling any necessary adaptations to enhance care. Resilience should not be a crutch for poor system design, but a deliberate response when systems are stretched.

Objectives: The functional resonance analysis method (FRAM) is increasingly used to analyse healthcare processes. FRAM uses four steps to analyse a process and its potential variability. We systematically reviewed studies using FRAM in healthcare on how the four steps in FRAM are reported, defined and supported by data. Design: Systematic review following the preferred reporting items for systematic reviews and meta-analyses 2020 guidelines. Data sources: Web of Science, PubMed, Embase, Scopus, PsycINFO, Dimensions and Lens were searched up to December 2025. Eligibility criteria for selecting studies: All peer-reviewed studies using FRAM in a healthcare context that presented a FRAM visualisation were included. The papers had to be written in English. Data extraction and synthesis: Two independent reviewers screened titles and abstracts, and subsequently the full text of selected papers. Data was extracted reporting on the steps of FRAM, how functions were supported by data, and the functions and couplings of the visualisations. Results: Sixty-eight papers were included, of which 20 (29%) reported at least one aspect of all four steps in FRAM. While most studies (85%) described how functions were supported by data, the methods used varied widely. Terminology was interpreted differently concerning variability, the output of variability and the effect of combined variability. Conclusion: Most FRAM studies in healthcare do not report all steps of FRAM, and interpretations of key terms differ. FRAM studies should more clearly describe which steps of the method are conducted, and how data is collected and analysed. Refinement of FRAM guidelines, particularly on data use and terminology, would enhance consistency and comparability across studies. PROSPERO registration number: CRD42024592858.

Introduction: Some patients undergoing metabolic bariatric surgery (MBS) may transfer to another hospital for subsequent procedures. Due to legal constraints imposed by privacy regulations on inter-hospital data sharing, limited research has examined the characteristics and outcomes of these patients. This study aimed to identify the frequency and factors associated with hospital transfer using a novel privacy-enhancing approach based on secure multi-party computation (MPC). Methods: All primary and secondary MBS procedures registered in the Dutch Audit for Treatment of Obesity between January 1, 2014, and December 31, 2022, were considered. MPC enabled privacy-preserving linkage of surgeries across different hospitals. Patients undergoing secondary surgery in the same or a different hospital were compared on patient and treatment characteristics and outcomes of primary MBS to investigate associations with hospital transfer. Results: Two thousand three hundred eighty-two patients with data on both primary and secondary MBS were identified. A minority ( n = 275; 11.5%) underwent their second procedure elsewhere. At baseline, these patients on average were younger (37.9 vs. 42.5, p < 0.001), less often had hypertension or GERD, and had similar BMI (43.9 vs 43.9, p = 0.89) compared with those who stayed. At secondary surgery, the BMI of patients transferring hospitals on average was lower (39.0 vs. 43.0, p < 0.001), and the indication was more often recurrent weight gain (49.0% vs. 23.0%, p < 0.001). Conclusion: A minority of patients (1 in 9) transferred to a different hospital for secondary MBS. These patients were generally younger and had fewer obesity-related diseases. Although they presented with a lower BMI at the time of secondary surgery, they more frequently sought surgery for recurrent weight gain.

Background: The Functional Resonance Analysis Method (FRAM) analyses discrepancies between written protocols (Work-as-Imagined) and real-world practice (Work-as-Done) in healthcare. Work-as-Done is created based on multiple stakeholders, leading to variability in reported functions. No guidance exists how to manage this variability. This study examines between-stakeholder variation in Work-as-Done and its impact on differences from Work-as-Imagined in FRAM visualisations. Methods: Two FRAM studies were analysed: delirium diagnosis and treatment (1) and perioperative anticoagulant management in two hospitals (2). Heatmaps visualised between-stakeholder variability of reported functions in Work-as-Done. We assessed the impact of including only functions shared by multiple stakeholders on Work-as-Imagined versus Work-as-Done comparisons. Results: In study 1, 23 of 33 functions were shared among at least two stakeholders. In study 2, stakeholders shared 30 of 33 functions in Hospital 1 and 29 of 32 functions in Hospital 2. Including or excluding functions, e.g., only mentioned by one stakeholder, influenced the observed differences between Work-as-Imagined and Work-as-Done. Conclusions: Between-stakeholder variability in both studies influenced differences between Work-as-Imagined and Work-as-Done, which often is the starting point improving the process. Showing between-stakeholder variability in FRAM studies enhances transparency in researcher decision-making. This supports more informed analysis and discussion in process improvement efforts.

Background: Quality of metabolic bariatric surgery (MBS) care is often monitored by national registries using quality indicators (QIs), but data collection takes up considerable time and costs. QIs are mostly introduced merely based on expert opinion. Therefore, the study’s aim was to systematically evaluate whether all QIs from the Dutch Audit for Treatment of Obesity (DATO) are still relevant and useful to initiate quality improvement initiatives. Methods: Twenty-four QIs were evaluated using hospital data from 2022 to 2023. To test whether QIs measured the same quality of care aspect (parsimony and relevance), correlations of QI pairs were examined using Pearson correlation coefficients. Usefulness to identify improvement opportunities was considered limited when variance is ≤ 0.001 without any outliers identified, indicating that the QI could be retired. Actionability was assessed through line graphs of hospital performance over the years. Results: Eleven QIs were highly correlated to other QIs, particularly the follow-up and weight loss indicators at 2 and 4 years, and therefore lacked added value. The weight loss QIs showed minimal variance and were adjusted by increasing the threshold to achieving ≥ 25% total weight loss. Multiple QIs showed improving trends and thereby their actionability, most pronounced for postoperative complications. The final QI set measured three constructs with good validity: Cronbach’s alpha values 0.53 (safety), 0.70 (treatment effectiveness), and 0.43 (follow-up process). Conclusion: Through a systematic evaluation of the DATO QI set, a smaller set of 13 QIs was shown to capture the same relevant information to improve MBS care.

Background: The ring-augmented Roux-en-Y gastric bypass (raRYGB) has been reported to result in higher long-term weight loss compared to regular Roux-en-Y gastric bypass (RYGB). However, the type of ring used varied within studies, leading to heterogeneity in reported results. Therefore, this study compares the 5-year results of RYGB with and without ring augmentation using a specific prefabricated gastric ring. Methods: All consecutive patients from a single center who received primary raRYGB between June 1, 2016, and May 31, 2018, with complete 5-year follow-up data were included and compared to a propensity score matched cohort receiving RYGB in the same period from the Dutch Audit for Treatment of Obesity. To ensure fair effect estimation of placing a ring, only RYGB procedures with alimentary and biliopancreatic limb lengths similar to those of the raRYGB were considered eligible. The primary outcome was percentage total weight loss (%TWL). Secondary outcomes included recurrent weight gain (RWG), obesity complication improvement, and complications. Results: In total, 592 matched patients were analyzed. raRYGB was associated with higher %TWL at 5 years (31.5% versus 28.0%, β = 3.59, 95% CI [2.09–5.09], p < 0.01) and lower odds on RWG (odds ratio = 0.56, 95% CI [0.38–0.83], p < 0.01). Improvement of obesity complications and short-term complication rates were comparable in both groups. After 5 years, 13 patients (4%) had experienced ring-related complications needing reoperation. Conclusions: At 5 years, raRYGB was associated with higher %TWL and lower odds on RWG. The occurrence of ring-related complications was limited.