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Background Integrated occupational safety and health and patient safety management are essential for addressing the challenges faced by healthcare services today. Developing and evaluating tools that support this work is crucial. This project aims to assess the effectiveness of a structured method for systematic and integrated occupational safety and health and patient safety management systems (SIOHPS). Additionally, the project includes embedded economic and process evaluation. This article presents the overall design of the SIOHPS-project, with a specific focus on the design and evaluation of the (cost-)effectiveness study. Methods The project is guided by the Medical Research Council (MRC) framework for complex interventions and is coproduced with key stakeholders. The intervention is designed to support systematic occupational health and patient safety management systems, incorporating both Safety I and Safety II perspectives. It is grounded in safety culture theory and knowledge about team debriefing for learning. The intervention consists of several core components, including targeted education, end-of-shift team debriefings, and support for systematic management. The intervention is supported by a digital tool. A program theory guides the evaluation. A pragmatic stepped-wedge cluster-controlled design (p-SWD) is used, with hospital healthcare units as clusters. The p-SWD includes three steps, with at least four clusters transitioning from the control to the intervention group at each step. A minimum of twelve healthcare units from two different regions in Sweden will participate. The intervention effect will be evaluated using sick leave and quality of care as primary outcomes. Secondary outcomes include safety climate, work environment factors, healthcare worker health, performance, patient safety and quality of nursing care. Primary and secondary analyses are conducted based on intention-to-treat approach. Cost-effectiveness will be assessed using cost-benefit and cost-consequence analyses. Discussion The need of methods that integrate systematic occupational safety and health and patient safety management has been emphasized by different stakeholders worldwide. The SIOHPS study has strong potential for nationwide implementation in Sweden to help healthcare organizations address current challenges. Additionally, the project will contribute to existing safety culture theory by exploring the integration of these domains. Trial registration ClinicalTrials.gov Identifier: NCT06398860. Registration date: 2024-04-30.

Background Patient safety, defined by the WHO as the absence of preventable harm, is a critical component of healthcare quality and poses a significant challenge globally. This study aimed to evaluate the effectiveness of SinergiAPS, a patient-centred audit and feedback intervention, in improving patient safety in primary healthcare (PHC) centres. Methods We conducted a 12-month cluster randomized controlled, multicentre trial. Fifty-nine PHC centres (1053 PHC professionals) in Spain were recruited and randomly allocated (1:1) to usual care or SinergiAPS intervention. The SinergiAPS intervention comprised: a bespoke feedback report with results from audits of patient safety based on the Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC) questionnaire, administered to 75 patients/centre; a set of educational materials, and a structured template to record safety improvement plans. The primary outcome (at the PHC professional level) was patient safety culture (Medical Office Survey on Patient Safety Culture (MOSPSC) questionnaire). Secondary outcomes (at the centre level) were patient-reported safety (six PREOS-PC scales), and rate of avoidable hospital admissions. After a 12-month follow-up, we conducted 15 semi-structured interviews with PHC professionals to explore their perceptions of the intervention. Results During the 12-month follow-up, 10 of the 30 centres in the intervention group held action plan team meetings and eight registered 57 safety improvement action plans. The plans aimed to improve patient activation, address treatment-related incidents, enhance communication between patients and providers, and strengthen patient safety culture. At 12 months, no significant differences were observed in MOSPSC mean score (intervention: 3.60 [95% CI 3.55 to 3.64] vs. control: 3.64 [3.60 to 3.68]). Similarly, no differences were observed in the secondary outcomes, with both groups experiencing a decline in patient-reported safety and avoidable hospital admissions. The qualitative interviews evidenced that the onset of the COVID-19 pandemic 6–9 weeks after initiating the follow-up period severely limited PHC’s capacity of developing and implementing safety improvement action plans, despite high levels of acceptability and perceived utility of the SinergiAPS intervention. Conclusions In the context of the health emergency caused by the COVID-19 pandemic, SinergiAPS did not improve patient safety in Spanish PHC centres. Trial registration ClinicalTrials.gov (NCT03837912).

Rehabilitation is crucial for postoperative patients with low back pain (LBP). However, the implementation of traditional clinic-based programs is limited in developing countries, such as China, because of the maldistribution of medical resources. Mobile phone-based programs may be a potential substitute for those who have no access to traditional rehabilitation. The aim of this study was to examine the efficacy of mobile phone-based rehabilitation systems in patients who underwent lumbar spinal surgery. Patients who accepted spinal surgeries were recruited and randomized into 2 groups of rehabilitation treatments: (1) a mobile phone-based eHealth (electronic health) program (EH) or (2) usual care treatment (UC). The primary outcomes were (1) function and pain status assessed by the Oswestry Disability Index (ODI) and (2) the visual analog scale (VAS). Secondary outcomes were (1) general mental health and (2) quality of life (Likert scales, EuroQol-5 Dimension health questionnaire, and 36-item Short-Form Health Survey). All the patients were assessed preoperatively and then at 3, 6, 12, and 24 months postoperatively. A total of 168 of the 863 eligible patients were included and randomized in this study. Our analysis showed that the improvement of primary outcomes in the EH group was superior to the UC group at 24 months postoperatively (ODI mean 7.02, SD 3.10, P<.05; VAS mean 7.59, SD 3.42, P<.05). No significant difference of primary outcomes was found at other time points. A subgroup analysis showed that the improvements of the primary outcomes were more significant in those who completed 6 or more training sessions each week throughout the trial (the highest compliance group) compared with the UC group at 6 months (ODI mean 17.94, SD 5.24, P<.05; VAS mean 19.56, SD 5.27, P<.05), 12 months (ODI mean 13.39, SD 5.32, P<.05; VAS mean 14.35, SD 5.23, P<.05), and 24 months (ODI mean 18.80, SD 5.22, P<.05; VAS mean 21.56, SD 5.28, P<.05). This research demonstrated that a mobile phone-based telerehabilitation system is effective in self-managed rehabilitation for postoperative patients with LBP. The effectiveness of eHealth was more evident in participants with higher compliance. Future research should focus on improving patients' compliance. Chinese Clinical Trial Registry ChiCTR-TRC-13003314; http://www.chictr.org.cn/showproj.aspx?proj=6245 (Archived by WebCite at http://www.webcitation.org/766RAIDNc).

Background Patient safety is a key target in public health, health services and medicine. Communication between all parties involved in gynecology and obstetrics (clinical staff/professionals, expectant mothers/patients and their partners, close relatives or friends providing social support) should be improved to ensure patient safety, including the avoidance of preventable adverse events (pAEs). Therefore, interventions including an app will be developed in this project through a participatory approach integrating two theoretical models. The interventions will be designed to support participants in their communication with each other and to overcome difficulties in everyday hospital life. The aim is to foster effective communication in order to reduce the frequency of pAEs. If communication is improved, clinical staff should show an increase in work satisfaction and patients should show an increase in patient satisfaction. Methods The study will take place in two maternity clinics in Germany. In line with previous studies of complex interventions, it is divided into three interdependent phases. Each phase provides its own methods and data. Phase 1: Needs assessment and a training for staff ( n  = 140) tested in a pre-experimental study with a pre/post-design. Phase 2: Assessment of communication training for patients and their social support providers ( n  = 423) in a randomized controlled study. Phase 3: Assessment of an app supporting the communication between staff, patients, and their social support providers ( n  = 423) in a case-control study. The primary outcome is improvement of communication competencies. A range of other implementation outcomes will also be assessed (i.e. pAEs, patient/treatment satisfaction, work satisfaction, safety culture, training-related outcomes). Discussion This is the first large intervention study on communication and patient safety in gynecology and obstetrics integrating two theoretical models that have not been applied to this setting. It is expected that the interventions, including the app, will improve communication practice which is linked to a lower probability of pAEs. The app will offer an effective and inexpensive way to promote effective communication independent of users’ motivation. Insights gained from this study can inform other patient safety interventions and health policy developments. Trial registration ClinicalTrials.gov Identifier: NCT03855735 ; date of registration: February 27, 2019.

ImportanceCompliance with the surgical safety checklist during operative procedures has been shown to reduce inhospital mortality and complications but proper execution by the surgical team remains elusive.ObjectiveWe evaluated the impact of remote video auditing with real-time provider feedback on checklist compliance during sign-in, time-out and sign-out and case turnover times.Design, settingProspective, cluster randomised study in a 23-operating room (OR) suite.ParticipantsSurgeons, anaesthesia providers, nurses and support staff.ExposureORs were randomised to receive, or not receive, real-time feedback on safety checklist compliance and efficiency metrics via display boards and text messages, followed by a period during which all ORs received feedback.Main outcome(s) and measure(s)Checklist compliance (Pass/Fail) during sign-in, time-out and sign-out demonstrated by (1) use of checklist, (2) team attentiveness, (3) required duration, (4) proper sequence and duration of case turnover times.ResultsSign-in, time-out and sign-out PASS rates increased from 25%, 16% and 32% during baseline phase (n=1886) to 64%, 84% and 68% for feedback ORs versus 40%, 77% and 51% for no-feedback ORs (p<0.004) during the intervention phase (n=2693). Pass rates were 91%, 95% and 84% during the all-feedback phase (n=2001). For scheduled cases (n=1406, 71%), feedback reduced mean turnover times by 14% (41.4 min vs 48.1 min, p<0.004), and the improvement was sustained during the all-feedback period. Feedback had no effect on turnover time for unscheduled cases (n=587, 29%).Conclusions and relevanceOur data indicate that remote video auditing with feedback improves surgical safety checklist compliance for all cases, and turnover time for scheduled cases, but not for unscheduled cases.

Background Improving medication safety implies patient-centred multidisciplinary cooperation. During the hospital stay for an acute care episode, the patient needs a comprehensive management to guarantee the best possible outcome. Methods The study was designed as a non-blinded, multicentre stepped-wedge cluster randomised clinical trial, taking place in six French University Hospitals. Each cluster began with the control period in which standard care did not include pharmaceutical intervention. Every 14-day period, one hospital unit was electronically randomised to switch to the intervention period until all cluster groups received the intervention, which consisted of collaborative pharmaceutical care (CPC) associating medication reconciliation at hospital admission, pharmaceutical analysis of the medication order, medication review and collaborative meeting. The primary outcome was assessing the intervention through the rate of patients with at least one medication error (ME) on the admission medication order (such as omission, wrong dose or wrong route of administration), comparing the two periods. Results CPC decreased the rate of patients with at least one ME from 88.9% (n = 243) to 29.2% (n = 267) ( p  < 0.0001). A total of 1817 MEs were discovered, of which 1121 (61.7%) were in the control period and 696 (38.3%) in the intervention period before resolution by the CPC. After resolving 567 of them, 129 medication errors still remained after CPC. So, a median of 3 MEs [IQR = 1;6] per patient were detected in the control period vs 0 [IQR = 0;1] after CPC in the intervention period ( p  < 0.0001). Patients were 21-times more likely to avoid a ME with CPC (OR: 20.8 [8.3;52.2], p  < 0.0001). The rate of patients with a 2–3 critical ME level decreased from 70.8% to 12.0% in the control vs intervention periods respectively (OR: 18.4 [7.7;43.9], p  < 0.0001). Conclusions CPC can prevent the occurrence of MEs and thus can improve inpatients’ medication management and safety. Pharmacists play a key role in combating medication-related harm in healthcare settings. Trial registration This study is registered on ClinicalTrials.gov with the reference number NCT02598115 (2015–11–04).

Introduction Patient safety is vital to health care delivery and service quality. Therefore, it should be a priority in every healthcare system worldwide. As the importance of patient safety is increasingly recognized, the emphasis on training and its impact on safety competencies and quality of care has also grown. Innovation in education is essential to keep pace with the growing need to enhance patient safety through an effective education program. Therefore, this study was conducted to compare the effectiveness of the patient safety education program in Case-based Learning (CBL), lectures, and reflection on the knowledge, attitude, and performance of patient safety in the nurses of the Intensive care unit (ICU) and emergency department of Shahid Rahnemoon Hospital, Yazd. Method The quasi-experimental study was conducted by the nurses of the intensive care unit and emergency departments of Shahid Rahnamoon Teaching Hospital, Yazd, Iran, from November 2023 to the end of April 2024, using a three-group quasi-experimental intervention design with a pre and post-test. Nurses were randomly divided into three teaching groups: lecture, case-based learning, and reflection. The knowledge, attitude, and patient safety performance questionnaires were used before and three months after the intervention. Results In this study, 113 nurses were analyzed across three groups: Case-Based Learning (CBL) with 38 participants, reflection with 38 participants, and lecture with 37 participants. The mean scores for knowledge pre- and post-study in the three groups were as follows: CBL (4.81 ± 1.24 vs. 8.07 ± 1.36), reflection (4.94 ± 1.39 vs. 8.18 ± 1.44), and lecture (5.16 ± 1.42 vs. 7.75 ± 1.40). Similarly, the average scores for attitude pre- and post-study were recorded as: CBL (41.50 ± 4.89 vs. 54.68 ± 4.64), reflection (41.23 ± 6.22 vs. 49.94 ± 6.42), and lecture (41.37 ± 6.75 vs. 48.62 ± 5.64). For practice, the average scores pre- and post-study were CBL (3.44 ± 1.05 vs. 6.26 ± 1.22), reflection (3.55 ± 1.08 vs. 5.76 ± 1.58), and lecture (3.59 ± 1.06 vs. 5.13 ± 1.53). These results indicate overall knowledge, attitude, and practice improvement across all groups following the study. Before the study, there were no significant differences in knowledge (F = 0.621, p  = 0.539), attitude (F = 0.018, p  = 0.982), and practice (F = 0.19, p  = 0.828) among the three groups. After the study, no significant difference was found in knowledge (F = 0.938, p  = 0.394); however, a significant difference was observed in attitude (F = 12.13, p  < 0.0001) and practice (F = 506, p  = 0.005). Conclusion According to the study's findings, all three groups of nurses demonstrated significantly higher scores in knowledge, attitudes, and performance after the intervention compared to before. However, no significant difference was observed among the three groups in the area of knowledge. Nonetheless, case-based learning significantly improved the average scores for attitudes and performance. These results indicate that patient safety training programs effectively enhance nurses' knowledge.

Objective To assess the efficacy and safety of sitagliptin in youth with type 2 diabetes (T2D) inadequately controlled with metformin ± insulin. Study Design Data were pooled from two 54‐week, double‐blind, randomized, placebo‐controlled studies of sitagliptin 100 mg daily or placebo added onto treatment of 10‐ to 17‐year‐old youth with T2D and inadequate glycemic control on metformin ± insulin. Participants (N = 220 randomized and treated) had HbA1c 6.5%–10% (7.0%–10% if on insulin), were overweight/obese at screening or diagnosis and negative for pancreatic autoantibodies. The primary endpoint was change from baseline in HbA1c at Week 20. Results Treatment groups were well balanced at baseline (mean HbA1c = 8.0%, BMI = 30.9 kg/m2, age = 14.4 years [44.5% <15], 65.9% female). The dose of background metformin was >1500 mg/day for 71.8% of participants; 15.0% of participants were on insulin therapy. At Week 20, LS mean changes from baseline (95% CI) in HbA1c for sitagliptin/metformin and placebo/metformin were −0.58% (−0.94, −0.22) and −0.09% (−0.43, 0.26), respectively; difference = −0.49% (−0.90, −0.09), p = 0.018; at Week 54 the LS mean (95% CI) changes were 0.35% (−0.48, 1.19) and 0.73% (−0.08, 1.54), respectively. No meaningful differences between the adverse event profiles of the treatment groups emerged through Week 54. Conclusions These results do not suggest that addition of sitagliptin to metformin provides durable improvement in glycemic control in youth with T2D. In this study, sitagliptin was generally well tolerated with a safety profile similar to that reported in adults. (ClinicalTrials.gov: NCT01472367, NCT01760447; EudraCT: 2011‐002529‐23/2014‐003583‐20, 2012‐004035‐23).

Objective To assess the efficacy and safety of DPP‐4 inhibition with sitagliptin in youth with type 2 diabetes (T2D). Study Design This was a 54‐week, double‐blind, randomized, controlled clinical trial evaluating the safety and efficacy of DPP‐4 inhibition with sitagliptin 100 mg once daily as initial oral therapy in youth with T2D. The 190 participants, aged 10–17 years, had HbA1c 6.5%–10% (7.0%–10% if on insulin). All were negative for pancreatic autoantibodies and overweight/obese at screening or diagnosis. The trial was placebo controlled for the first 20 weeks, after which metformin replaced placebo. The primary efficacy endpoint was change from baseline in HbA1c at Week 20. Results Treatment groups were well balanced at baseline (mean ± SD HbA1c = 7.5% ± 1.0, BMI percentile = 97.1% ± 6.8, age = 14.0 years ± 2.0 [57.4% <15], 60.5% female). At Week 20, least squares mean changes from baseline in HbA1c were −0.01% (sitagliptin) and 0.18% (placebo); between‐group difference (95% CI) = −0.19% (−0.68, 0.30), p = 0.448. At Week 54, the changes in HbA1c were 0.45% (sitagliptin) and −0.11 (placebo/metformin). There were no notable between‐group differences in the adverse event profiles through Week 54. Conclusions DPP‐4 inhibition with sitagliptin did not provide significant improvement in glycemic control. In this study, sitagliptin was generally well tolerated with a safety profile similar to that reported in adults. (ClinicalTrials.gov: NCT01485614; EudraCT: 2011‐002528‐42)