Patient-reported outcome measures (PROMs) after elective hip, knee and shoulder arthroplasty: protocol for a prospective cohort study

Background The number of hip, knee and shoulder arthroplasties continues to rise worldwide. The Organization for Economic Cooperation and Development has launched an initiative (called PaRIS Initiative) for the systematic collection of Patient Reported Outcome Measures (PROMs) in patients undergoing elective hip and knee arthroplasty. The Rizzoli Orthopedic Institute (IOR) was selected as a pilot center for the launch of the Initiative in Italy given that IOR hosts the Registry of Orthopedic Prosthetic Implants (RIPO), a region-wide registry which collects joint implant data from all the hospitals in the Emilia-Romagna Region. In this specific geographic area information related to PROMs after joint replacement is unknown. This paper describes the protocol of a study (PaRIS-IOR) that aims to implement the collection of a set of PROMs within an existing implant registry in Italy. The study will also investigate the temporal trend of PROMs in relation to the type of prosthesis and the type of surgical intervention. Methods The PaRIS-IOR study is a prospective, single site, cohort study that consists of the administration of PROMs questionnaires to patients on the list for elective arthroplasty. The questionnaires will be administered to the study population within 30 days before surgery, and then at 6 and 12 months following surgery. The study population will consist of consecutive adult patients undergoing either hip, knee or shoulder arthroplasty. The collected data will be linked with those routinely collected by the RIPO in order to assess the temporal trend of PROMs in relation to the type of prosthesis and the type of surgical intervention. Discussion The PaRIS-IOR study could have important implications in targeting the factors influencing functional outcomes and quality of life reported by patients after hip, knee and shoulder arthroplasty, and will also represent the first systematic collection of PROMs related to arthroplasty in Italy

Promuovere il coinvolgimento dei pazienti per migliorare la sicurezza in chirurgia

Background: Patient safety has become essential with increasing complexity of health systems and the consequent increase in patient damage. Clinical risk management aims to prevent and reduce the risks, errors and damages that occur to patients during health care. The direct involvement of patients in care pathways can be both an important source of information on potential risks and a resource for improving safety.Objective: To improve patient safety in surgery by promoting the active involvement of patients admitted to an orthopedic department.Method: After check-in, a checklist was administered to the patients, consisting of 21 items that took into consideration the good practices to be applied in surgery. The checklists returned by the patients at the end of their stay were analyzed to identify any areas for improvement.Results: From July 2019 to September 2019, the checklists were administered to 76 patients who underwent hip or knee arthroplasty, admitted to an orthopedic ward. 63% of the delivered checklists were returned by the patients. The analysis made it possible to verify that good practices for safety in surgery are effectively applied by health personnel. However, some critical areas were identified on which to intervene with improvement actions.Conclusions: This work demonstrates that patient involvement can help improve the safety of the surgical path, in order to prevent potential adverse events. Further studies are needed with sufficient sample power to validate the findings of this work

La tecnica di analisi proattiva FMEA/FMECA per la gestione del rischio clinico in diagnostica di laboratorio

[FMEA/FMECA proactive analysis technique for clinical risk management in laboratory diagnostics]At the IRCCS Rizzoli Orthopaedic Institute of Bologna the FMEA/FMECA technique has been used for several years in the laboratory diagnostics setting for the analysis of processes, the proactive identification of possible mistakes and the implementation of improvement actions. In five laboratories of the Institute, current critical processes have been mapped to identify priority risks. Therefore, the intervention priorities have been defined, the improvement plans implemented and the efficacy in reducing the risks evaluated. The results were assessed by calculating the index of improvement (IM), as the ratio between the value of the Risk Priority Number (RPN) obtained by an evaluation before (ex-ante) and after (ex-post) the improvement actions. In all analyzed diagnostic processes initial values RPN were reduced and all IM showed values > 1. In addition, as result of risk analysis, 75 improvement actions were implemented, divided into: training/information (18,7%), organizational changes (53,3%), acquisition/maintenance of equipment and technologies (10,7%), revision and elaboration of procedures/protocols (16%), structural adjustments (1,3%).The technique FMEA/FMECA has proven to be useful to identify critical and high-risk processes proactively and to implement improvement actions according to priorities

Informatizzazione della checklist per la sicurezza in sala operatoria e i risultati raggiunti presso l'Istituto Ortopedico Rizzoli di Bologna

[Computerization of the checklist in the operating room safety and the results achieved at the Rizzoli Orthopaedic Institute in Bologna] Since 2010, the Rizzoli Orthopaedic Institute in Bologna has joined the project of the Emilia-Romagna «Project SOS.net: Network operating theaters safe», adopting the surgical safety checklist regional in hard copy from three surgical units.Over the years, the adoption of the checklist has been extended to all surgical units, thanks to the computerization of the same: at the Institute had in fact been initiated a process of computerization of operating rooms, which also included the introduction/editing tools for the management of clinical risk in the operating room. This change has allowed not only to integrate computationally the moment of verification, by means of the surgical safety checklist regional, with the detection of deviations from the expected standard but also to be able to have specific reporting in real time.These implementations have been accompanied by appropriate training and organizational interventions, bringing the level of adherence to the instrument until it reaches almost 100%.

Applicazione di un sistema di mappatura dei rischi nella Diagnostica per Immagini

[Applying a system of risk mapping in Diagnostic Imaging]Six hospitals in Emilia-Romagna have developed a system of detection and classification of adverse events in Diagnostic Imaging, according to a mapping of hazards, in order to assess and ensure greater patient’s safety. A seventeen-month trial was carried out using this system and involving 19 operational units in several Diagnostic Imaging-related branches (Diagnostic and Interventional Radiology, Nuclear Medicine, Neuroradiology, Ultrasound). The project is a multi-center spin-off of the broader program of the Agenzia Sanitaria e Sociale Regionale – Regione Emilia-Romagna (ASSR-RER) of clinical risk management in healthcare organizations. This experience has demonstrated the importance of the classification of adverse events and near misses in radiology and the preparation of a specific incident reporting form that will facilitate the voluntary reporting of events by medical personnel. The data analysis has provided reassuring data concerning the overall safety of the Radiology Departments examined

Impact of rehabilitation on mortality and readmissions after surgery for hip fracture

Abstract Background Hip fracture in elderly patients is a rising global public health concern because of population ageing, and increasing frailty. Long-term morbidity related to poor management of hip fracture is associated with decreased quality of life, survival, and increase in healthcare costs. Receiving postoperative rehabilitation is associated with better outcomes and a higher likelihood of returning to pre-existing level of functioning. However little is known about which postoperative rehabilitation pathways are more effective to optimize patient outcomes. Few studies have analyzed postoperative rehabilitation pathways in a universal healthcare system. The aim of this study is to analyze the impact of post-acute rehabilitation pathways on mortality and readmission in elderly patients undergoing surgery for hip fracture in a large metropolitan area in Italy. Methods In this retrospective cohort study, we analyzed 6-month mortality from admission and 6-month readmission after hospital discharge in patients who underwent surgical repair for hip fracture in the hospitals of the Bologna metropolitan area between 1.1.2013 and 30.6.2014. Data were drawn from the regional hospital discharge records database. Kaplan-Meier estimates and multiple Cox regression were used to analyze mortality as a function of rehabilitation pathways. Multiple logistic regression determined predictors of readmission. Results The study population includes 2208 patients, mostly women (n = 1677, 76%), with a median age of 83.8 years. Hospital rehabilitation was provided to 519 patients (23.5%), 907 (41.1%) received rehabilitation in private inpatient rehabilitation facilities (IRF) accredited by the National Health System, and 782 (35.4%) received no post-acute rehabilitation. Compared with patient receiving hospital rehabilitation, the other groups showed significantly higher mortality risks (no rehabilitation, Hazard Ratio (HR) = 2.19, 95%CI = 1.54–3.12, p < 0.001; IRF rehabilitation, HR = 1.66, 95%CI = 1.54–1.79, p < 0.001). The risk of readmission did not differ significantly among rehabilitation pathways. Conclusions Intensive hospital rehabilitation was significantly associated with a lower risk of mortality compared to IRF rehabilitation and no rehabilitation. Our results may help in the development of evidence-based recommendations aimed to improve resource utilization and quality of care in hip fracture patients. Further research is warranted to investigate the impact of the rehabilitation pathway on other outcomes, such as patients’ functional status and quality of life

Evaluating patient safety indicators in orthopedic surgery between Italy and the USA

Objective: To compare patient safety in major orthopedic procedures between an orthopedic hospital in Italy, and 26 US hospitals of similar size.Design: Retrospective analysis of administrative data from hospital discharge records in Italy and Florida, USA, 2011-13. Patient Safety Indicators (PSIs) developed by the Agency for Healthcare Quality and Research were used to identify inpatient adverse events (AEs). We examined the factors associated with the development of each different PSI, taking into account known confounders, using logistic regression.Setting: One Italian orthopedic hospital and 26 hospitals in Florida with 65 1000 major orthopedic procedures per year.Participants: Patients 65 18 years who underwent 1 of the 17 major orthopedic procedures, and with a length of stay (LOS) > 1 day.Intervention: Patient Safety management between Italy and the USA.Main Outcome Measure: Patient Safety Indicators.Results: A total of 14 393 patients in Italy (mean age = 59.8 years) and 131 371 in the USA (mean age = 65.4 years) were included. US patients had lower adjusted odds of developing a PSI compared to Italy for pressure ulcers (odds ratio [OR]: 0.21; 95% confidence interval [CI]: 0.10-0.45), hemorrhage or hematoma (OR: 0.42; CI 0.23-0.78), physiologic and metabolic derangement (OR: 0.08; CI 0.02-0.37). Italian patients had lower odds of pulmonary embolism/deep vein thrombosis (OR: 3.17; CI 2.16-4.67) compared to US patients.Conclusions: Important differences in patient safety events were identified across countries using US developed PSIs. Though caution about potential coding differences is wise when comparing PSIs internationally, other differences may explain AEs, and offer opportunities for cross-country learning about safe practices

The incidence and risk factors of selected drug prescriptions and outpatient care after SARS-CoV-2 infection in low-risk subjects: a multicenter population-based cohort study

Background: Knowledge about the dynamics of transmission of SARS-CoV-2 and the clinical aspects of COVID-19 has steadily increased over time, although evidence of the determinants of disease severity and duration is still limited and mainly focused on older adult and fragile populations. Methods: The present study was conceived and carried out in the Emilia-Romagna (E-R) and Veneto Regions, Italy, within the context of the EU's Horizon 2020 research project called ORCHESTRA (Connecting European Cohorts to increase common and effective response to SARS-CoV-2 pandemic) (www.orchestra-cohort.eu). The study has a multicenter retrospective population-based cohort design and aimed to investigate the incidence and risk factors of access to specific healthcare services (outpatient visits and diagnostics, drug prescriptions) during the post-acute phase from day-31 to day-365 after SARS-CoV-2 infection, in a healthy population at low risk of severe acute COVID-19. The study made use of previously recorded large-scale healthcare data available in the administrative databases of the two Italian Regions. The statistical analysis made use of methods for competing risks. Risk factors were assessed separately in the two Regions and results were pooled using random effects meta-analysis. Results: There were 35,128 subjects in E-R and 88,881 in Veneto who were included in the data analysis. The outcome (access to selected health services) occurred in a high percentage of subjects in the post-acute phase (25% in E-R and 21% in Veneto). Outpatient care was observed more frequently than drug prescriptions (18% vs. 12% in E-R and 15% vs. 10% in Veneto). Risk factors associated with the outcome were female sex, age greater than 40 years, baseline risk of hospitalization and death, moderate to severe acute COVID-19, and acute extrapulmonary complications. Conclusion: The outcome of interest may be considered as a proxy for long-term effects of COVID-19 needing clinical attention. Our data suggest that this outcome occurs in a substantial percentage of cases, even among a previously healthy population with low or mild severity of acute COVID-19. The study results provide useful insights into planning COVID-19-related services