Implementation of an infection prevention bundle is associated with reduced surgical site infections in cranial neurosurgery.

OBJECTIVE: The objective of this study was to quantify surgical site infection (SSI) rates after cranial neurosurgery in a tertiary care hospital, identify risk factors for SSI, and evaluate the impact of standardized surveillance and an infection prevention bundle (IPB). METHODS: The authors compared SSI rates during 7 months before and after the intervention. The IPB included standardized patient preparation, perioperative antibiotic/antiseptic use, barrier precautions, coaching of surgeons, and the implementation of a specialized technical operation assistant team. RESULTS: Three hundred twenty-two unselected consecutive patients were evaluated before the IPB, and 296 were evaluated after implementation. Infection rates after 1 year decreased from 7.8% (25/322) to 3.7% (11/296, p = 0.03) with similar mortality rates (14.7% vs 13.8%, p = 0.8). The isolated bacteria included Staphylococcus aureus (42%), Cutibacterium acnes (22%), and coagulase-negative staphylococci (14%). Organ/space infections dominated with 67%, and mostly consisted of subdural empyema and meningitis/ventriculitis. Among the 36 SSIs, 13 (36%) occurred during hospitalization, and 29 (81%) within the first 3 months of follow-up. In multivariable analysis including established risk factors described in the literature, non-CNS neoplasia (odds ratio [OR] 3.82, 95% confidence interval [CI] 1.39-10.53), postoperative bleeding (OR 4.09, 1.44-11.62), operations performed by or under supervision of a senior faculty surgeon (OR 0.38, 0.17-0.84), and operations performed after the implementation of standardized surveillance and an IPB (OR 0.38, 0.17-0.85) significantly influenced the infection rate. CONCLUSIONS: The introduction of an IPB combined with routine surveillance and personal feedback was associated with a 53% reduced infection rate. The lower infection rates of senior faculty and the strong association between postoperative bleeding and infection underline the importance of both surgical experience as well as thorough supervision and coaching of younger surgeons.

Use of the FallAkte Plus System as an IT Infrastructure for the North Rhine-Westphalian General Practice Research Network: Mixed Methods Usability Study.

BACKGROUND: Primary care research networks can generate important information in the setting where most patients are seen and treated. However, this requires a suitable IT infrastructure (ITI), which the North Rhine-Westphalian general practice research network is looking to implement. OBJECTIVE: This mixed methods research study aims to evaluate (study 1) requirements for an ITI and (study 2) the usability of an IT solution already available on the market, the FallAkte Plus (FA+) system for the North Rhine-Westphalian general practice research network, which comprises 8 primary care university institutes in Germany's largest state. METHODS: In study 1, a survey was conducted among researchers from the institutes to identify the requirements for a suitable ITI. The questionnaire consisted of standardized questions with open-ended responses. In study 2, a mixed method approach combining a think-aloud approach and a quantitative survey was used to evaluate the usability and acceptance of the FA+ system among 3 user groups: researchers, general practitioners, and practice assistants. Respondents were asked to assess the usability with the validated system usability scale and to test a short questionnaire on vaccination management through FA+. RESULTS: In study 1, five of 8 institutes participated in the requirements survey. A total of 32 user requirements related primarily to study management were identified, including data entry, data storage, and user access management. In study 2, a total of 36 participants (24 researchers and 12 general practitioners or practice assistants) were surveyed in the mixed methods study of an already existing IT solution. The tutorial video and handouts explaining how to use the FA+ system were well received. Researchers, unlike practice personnel, were concerned about data security and data protection regarding the system's emergency feature, which enables access to all patient data. The median overall system usability scale rating was 60 (IQR 33.0-85.0), whereby practice personnel (median 82, IQR 58.0-94.0) assigned higher ratings than researchers (median 44, IQR 14.0-61.5). Users appreciated the option to integrate data from practices and other health care facilities. However, they voted against the use of the FA+ system due to a lack of support for various study formats. CONCLUSIONS: Usability assessments vary markedly by professional group and role. In its current stage of development, the FA+ system does not fully meet the requirements for a suitable ITI. Improvements in the user interface, performance, interoperability, security, and advanced features are necessary to make it more effective and user-friendly. Collaborating with end users and incorporating their feedback are crucial for the successful development of any practice network research ITI.

Recommendations on self-management interventions for adults living with obesity: COMPAR-EU project.

Self-management interventions (SMIs) may improve disease management in adults living with obesity. We formulated evidence-based recommendations for SMIs within the context of the COMPAR-EU project. The multidisciplinary panel selected critical outcomes based on the COMPAR-EU core outcome set and established decision thresholds for each outcome. Recommendations were informed by systematic reviews of effects, cost-effectiveness, and a contextual assessment. To assess the certainty of the evidence and formulate the recommendations, we used the GRADE approach guidance. Overall, SMIs were deemed to have a small impact, but the absence of harmful effects and potential cumulative benefits indicated a favourable balance of effects, despite low certainty. SMIs showed variations in structure, intensity, and resource utilisation, but overall are likely to be cost-effective. Adapting SMIs to local contexts would enhance equity, acceptability, and feasibility, considering patients' values, and availability of resources and teamwork. Consequently, the panel made conditional recommendations favouring SMIs over usual care. The rigorous and explicit recommendations demonstrated the effectiveness of SMIs for adults living with obesity. However, the gaps in the literature influenced the panel to make only conditional recommendations in favour of SMIs. Further research is needed to strengthen the evidence base and improve recommendations' certainty and applicability.

COMPAR-EU Recommendations on Self-Management Interventions in Type 2 Diabetes Mellitus.

Self-management interventions (SMIs) offer a promising approach to actively engage patients in the management of their chronic diseases. Within the scope of the COMPAR-EU project, our goal is to provide evidence-based recommendations for the utilisation and implementation of SMIs in the care of adult individuals with type 2 diabetes mellitus (T2DM). A multidisciplinary panel of experts, utilising a core outcome set (COS), identified critical outcomes and established effect thresholds for each outcome. The panel formulated recommendations using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach, a transparent and rigorous framework for developing and presenting the best available evidence for the formulation of recommendations. All recommendations are based on systematic reviews (SR) of the effects and of values and preferences, a contextual analysis, and a cost-effectiveness analysis. The COMPAR-EU panel is in favour of using SMIs rather than usual care (UC) alone (conditional, very low certainty of the evidence). Furthermore, the panel specifically is in favour of using ten selected SMIs, rather than UC alone (conditional, low certainty of the evidence), mostly encompassing education, self-monitoring, and behavioural techniques. The panel acknowledges that, for most SMIs, moderate resource requirements exist, and cost-effectiveness analyses do not distinctly favour either the SMI or UC. Additionally, it recognises that SMIs are likely to enhance equity, deeming them acceptable and feasible for implementation.

Effectiveness and safety of a long-acting, once-daily, two-phase release formulation of methylphenidate (Ritalin ® LA) in school children under daily practice conditions.

Long-acting (LA) preparations of methylphenidate allow for once-daily dosing; however, pharmacokinetics may vary and depend on food intake. The objective was to evaluate effectiveness of a two-phase release formulation (Ritalin(®) LA) under daily practice conditions. This was a prospective, multicenter, observational study in Germany. Eligibility and dosing were determined by the physician based on the drug label. Outcomes included changes over 3 months of treatment in assessments of effect duration, clinical global impression (CGI), and quality of life (ILK). In 101 sites, 262 patients (197 boys, 63 girls, and two unknown) with a mean age of 10.9 years were enrolled; 50 were treated for the first time; 212 switched medication to Ritalin(®) LA. After 3 months, CGI improved in 59.4 % of patients, and well-being overall was rated as good by 61.0 % of parents and 63.7 % of children. Based on parents' assessment, the proportion of children suffering from strong disease burden decreased from 40.7 to 15.1 %. In 123 insufficient responders to previous ADHD medications, benefit from Ritalin(®) LA was above average and effect duration was significantly prolonged as compared to pretreatment. Overall, 28 patients (10.7 %) had treatment-related adverse events with one case being serious; 23 patients (8.8 %) discontinued therapy, 7 (2.7 %) due to poor treatment response; and 212 patients (81 %) continued treatment beyond the study. In line with clinical trial data, Ritalin(®) LA provides significant benefit also under routine practice conditions.