TAILR (Nursing-Sensitive Events and Their Association With Individual Nurse Staffing Levels) Project: Protocol for an International Longitudinal Multicenter Study.

BACKGROUND: Nursing-sensitive events (NSEs) are common, accounting for up to 77% of adverse events in hospitalized patients (eg, fall-related harm, pressure ulcers, and health care-associated infections). NSEs lead to adverse patient outcomes and impose an economic burden on hospitals due to increased medical costs through a prolonged hospital stay and additional medical procedures. To reduce NSEs and ensure high-quality nursing care, appropriate nurse staffing levels are needed. Although the link between nurse staffing and NSEs has been described in many studies, appropriate nurse staffing levels are lacking. Existing studies describe constant staffing exposure at the unit or hospital level without assessing patient-level exposure to nurse staffing during the hospital stay. Few studies have assessed nurse staffing and patient outcomes using a single-center longitudinal design, with limited generalizability. There is a need for multicenter longitudinal studies with improved potential for generalizing the association between individual nurse staffing levels and NSEs. OBJECTIVE: This study aimed (1) to determine the prevalence, preventability, type, and severity of NSEs; (2) to describe individual patient-level nurse staffing exposure across hospitals; (3) to assess the effect of nurse staffing on NSEs in patients; and (4) to identify thresholds of safe nurse staffing levels and test them against NSEs in hospitalized patients. METHODS: This international multicenter study uses a longitudinal and observational research design; it involves 4 countries (Switzerland, Sweden, Germany, and Iran), with participation from 14 hospitals and 61 medical, surgery, and mixed units. The 16-week observation period will collect NSEs using systematic retrospective record reviews. A total of 3680 patient admissions will be reviewed, with 60 randomly selected admissions per unit. To be included, patients must have been hospitalized for at least 48 hours. Nurse staffing data (ie, the number of nurses and their education level) will be collected daily for each shift to assess the association between NSEs and individual nurse staffing levels. Additionally, hospital data (ie, type, teaching status, and ownership) and unit data (ie, service line and number of beds) will be collected. RESULTS: As of January 2024, the verification process for the plausibility and comprehensibility of patients' and nurse staffing data is underway across all 4 countries. Data analyses are planned to be completed by spring 2024, with the first results expected to be published in late 2024. CONCLUSIONS: This study will provide comprehensive information on NSEs, including their prevalence, preventability, type, and severity, across countries. Moreover, it seeks to enhance understanding of NSE mechanisms and the potential impact of nurse staffing on these events. We will evaluate within- and between-hospital variability to identify productive strategies to ensure safe nurse staffing levels, thereby reducing NSEs in hospitalized patients. The TAILR (Nursing-Sensitive Events and Their Association With Individual Nurse Staffing Levels) study will focus on the optimization of scarce staffing resources. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/56262.

Timing of adverse events in patients undergoing acute and elective hip arthroplasty surgery: a multicentre cohort study using the Global Trigger Tool.

OBJECTIVE: To explore timing in relation to all types of adverse events (AEs), severity and preventability for patients undergoing acute and elective hip arthroplasty. DESIGN: A multicentre cohort study using retrospective record review with Global Trigger Tool methodology in combination with data from several registers. SETTING: 24 hospitals in 4 major regions of Sweden. PARTICIPANTS: Patients ≥18 years, undergoing acute or elective total or hemiarthroplasty of the hip, were eligible for inclusion. Reviews of weighted samples of 1998 randomly selected patient records were carried out using Global Trigger Tool methodology. The patients were followed for readmissions up to 90 days postoperatively throughout the whole country. RESULTS: The cohort consisted of 667 acute and 1331 elective patients. Most AEs occurred perioperatively and postoperatively (n=2093, 99.1%) and after discharge (n=1142, 54.1%). The median time from the day of surgery to the occurrence of AE was 8 days. The median days for different AE types ranged from 0 to 24.5 for acute and 0 to 71 for elective patients and peaked during different time periods. 40.2% of the AEs, both major and minor, occurred within postoperative days 0-5 and 86.9% of the AEs occurred within 30 days. Most of the AEs were deemed to be of major severity (n=1370, 65.5%) or preventable (n=1591, 76%). CONCLUSIONS: A wide variability was found regarding the timing of different AEs with the majority occurring within 30 days. The timing and preventability varied regarding the severity. Most of the AEs were deemed to be preventable and/or of major severity. To increase patient safety for patients undergoing hip arthroplasty surgery, a better understanding of the multifaceted nature of the timing of AEs in relation to the occurrence of differing AEs is needed.

Primary hemiarthroplasty for the elderly patient with cognitive dysfunction and a displaced femoral neck fracture: a prospective, observational cohort study.

BACKGROUND: At least one-third of hip fracture patients have some degree of impaired cognitive status, which may complicate their postoperative rehabilitation. AIM: We aimed to describe the outcome for elderly patients with cognitive dysfunction operated with hemiarthroplasty (HA) for a femoral neck fracture and to study the impact postoperative geriatric rehabilitation has on functional outcome up to 1 year after surgery. METHODS: 98 patients with a displaced femoral neck fracture with a mean age of 86 years were included and followed up to 1 year. The outcomes were hip-related complications and reoperations, the capacity to return to previous walking ability, health-related quality of life, hip function and mortality. RESULTS: The prevalence of hip complications leading to a major reoperation was 6% and the 1-year mortality rate was 31%. The lack of geriatric rehabilitation was correlated with poorer outcomes overall and those who receive geriatric rehabilitation were less likely to be confined to a wheelchair or bedridden at the 1-year follow-up. CONCLUSIONS: Hemiarthroplasty is an acceptable option for elderly patients with a displaced femoral neck fracture and cognitive dysfunction. A lack of structured rehabilitation is associated with a significant deterioration in walking ability despite a well-functioning hip. However, the causality of this could be due to selection bias of healthier patients being sent to geriatric rehabilitation.

Endoplasmic reticulum stress in human chronic wound healing: Rescue by 4-phenylbutyrate.

During wound healing, cells have a high rate of protein synthesis and many proteins need to be folded post-translationally to function, which occurs in the endoplasmic reticulum (ER). In addition to proliferation, several cellular stress conditions, such as hypoxia, in the wound micro-environment lead to the accumulation of unfolded or misfolded proteins in the ER, causing ER stress. Eukaryotic cells have a signalling system to manage ER stress called the unfolded protein response (UPR). Mild UPR activation has a beneficial homeostatic effect; however, excessive UPR induces cell death. Herein, we examined venous leg ulcer biopsies versus normal acute incisional wounds in age-matched elderly subjects and found a large increase in ER stress markers. To study the underlying mechanism, we established several cell cultures from amputated legs from the elderly that showed inherent ER stress. While both keratinocytes and fibroblasts migration was impaired by ER stress, migration of elderly leg skin keratinocytes was markedly improved after treatment with the chemical chaperone and clinically established drug 4-phenylbutyrate (4-PBA) and demonstrated a reduction in ER stress markers. In a full-thickness human skin wound healing model, 4-PBA improved the reepithelialisation rate, which suggests it as a promising drug repurposing candidate for wound healing.

The influence of depression on patient-reported outcomes for hip-fracture patients 1 year after surgery: a prospective cohort study.

BACKGROUND: Depression is common in elderly hip-fracture patients and together with cognitive impairment is associated with increased risk of mortality. AIM: We aimed to examine the influence depression has on patient-reported outcome up to 1 year after acute hip fracture. METHODS: 162 hip-fracture patients participated in the prospective observational cohort study and were followed up at baseline, and 3 and 12 months using patient-reported outcome scores. Patients with cognitive impairment were excluded. Depression was defined as a score ≥ 8 on the depression subscale of the Hospital Anxiety Depression Scale (HADS D), having a diagnosis of depression or being treated with anti-depressant medication. Hip function was assessed using Harris Hip Score (HHS), EQ-5D was used to assess health status and Quality of life, and the Pain Numerical Rating Scale (PRNS) was used to assess pain levels. A linear regression model adjusted for group, age, sex, and ASA class was used to identify risk factors for functional outcome 12 months after fracture. RESULTS: 35 patients were included in the depression group versus 127 in the control group. No statistical differences were found in the demographic data (age, sex, ASA class, fracture type, operation method, living situation, activities of daily living ADL and clinical pathway) between the groups. In the regression model, we found no correlation between depression and the patient-reported outcome. CONCLUSION: In young elderly hip fracture patients without cognitive dysfunction, depression may not be of major importance for the rehabilitation of hip function in the short term.

External Validity of the HOPE-Trial: Hemiarthroplasty Compared with Total Hip Arthroplasty for Displaced Femoral Neck Fractures in Octogenarians.

BACKGROUND: Randomized controlled trials (RCTs) are the most reliable way of evaluating the effect of new treatments by comparing them with previously accepted treatment regimens. The results obtained from an RCT are extrapolated from the study environment to the general health care system. The ability to do so is called external validity. We sought to evaluate the external validity of an RCT comparing the results of total hip arthroplasty with those of hemiarthroplasty for the treatment of displaced femoral neck fractures in patients ≥80 years of age. METHODS: This prospective, single-center cohort study included 183 patients ≥80 years of age who had a displaced femoral neck fracture. All patients were screened according to the inclusion and exclusion criteria for an RCT comparing total hip arthroplasty and hemiarthroplasty. The population for this study consisted of patients who gave their informed consent and were randomized into the RCT (consenting group, 120 patients) as well as those who declined to give their consent to participate (non-consenting group, 63 patients). The outcome measurements were mortality, complications, and patient-reported outcome measures. Follow-up was carried out postoperatively with use of a mailed survey that included patient-reported outcome questionnaires. RESULTS: We found a statistically significant and clinically relevant difference between the groups, with the non-consenting group having a higher risk of death compared with the consenting group. (hazard ratio, 4.6; 95% confidence interval, 1.9 to 11.1). No differences were found between the groups in terms of patient-reported outcome measures or surgical complications. CONCLUSIONS: This cohort study indicates a higher mortality rate but comparable hip function and quality of life among eligible non-consenters as compared with eligible consenters when evaluating the external validity of an RCT in patients ≥80 years of age with femoral neck fracture. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

HOPE-Trial: Hemiarthroplasty Compared with Total Hip Arthroplasty for Displaced Femoral Neck Fractures in Octogenarians: A Randomized Controlled Trial.

BACKGROUND: The choice of primary hemiarthroplasty or total hip arthroplasty in patients ≥80 years of age with a displaced femoral neck fracture has not been adequately studied. As the number of healthy, elderly patients ≥80 years of age is continually increasing, optimizing treatments for improving outcomes and reducing the need for secondary surgery is an important consideration. The aim of the present study was to compare the results of hemiarthroplasty with those of total hip arthroplasty in patients ≥80 years of age. METHODS: This prospective, randomized, single-blinded trial included 120 patients with a mean age of 86 years (range, 80 to 94 years) who had sustained an acute displaced femoral neck fracture <36 hours previously. The patients were randomized to treatment with hemiarthroplasty (n = 60) or total hip arthroplasty (n = 60). The primary end points were hip function and health-related quality of life at 2 years. Secondary end points included hip-related complications and reoperations, mortality, pain in the involved hip, activities of daily living, surgical time, blood loss, and general complications. The patients were reviewed at 3 months and 1 and 2 years. RESULTS: We found no differences between the groups in terms of hip function, health-related quality of life, hip-related complications and reoperations, activities of daily living, or pain in the involved hip. Hip function, activities of daily living, and pain in the involved hip deteriorated in both groups compared with pre-fracture values. The ability to regain previous walking function was similar in both groups. CONCLUSIONS: We found no difference in outcomes after treatment with either hemiarthroplasty or total hip arthroplasty in active octogenarians and nonagenarians with a displaced femoral neck fracture up to 2 years after surgery. Hemiarthroplasty is a suitable procedure in the short term for this group of patients. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Patient-reported outcomes after surgical and non-surgical treatment of proximal hamstring avulsions in middle-aged patients.

OBJECTIVES: In the literature on proximal hamstring avulsions, only two studies report the outcomes of non-surgically treated patients. Our objective was to compare subjective recovery after surgical and non-surgical treatment of proximal hamstring avulsions in a middle-aged cohort. METHODS: We included 47 patients (33 surgically and 14 non-surgically treated) with a mean (SD) age of 51 (±9) years in a retrospective cohort study. Follow-up time mean (SD) of 3.9 (±1.4) years. The outcome variables were the Lower Extremity Functional Scale (LEFS) and questions from the Proximal Hamstring Injury Questionnaire. Outcome variables were adjusted in regression models for gender, age, American Society of Anestesiologits (ASA) classification and MRI findings at diagnosis. RESULTS: The baseline characteristics showed no differences except for the MRI result, in which the surgically treated group had a larger proportion of tendons retracted ≥ 2 cm. The mean LEFS score was 74 (SD±12) in the surgically treated cohort and 72 (SD±16) in the non-surgically treated cohort. This was also true after adjusting for confounders. The only difference in outcome at follow-up was the total hours performing physical activity per week, p=0.02; surgically treated patients reported 2.5 hours or more (5.2 vs 2.7). CONCLUSION: This study on middle-aged patients with proximal hamstring avulsions was unable to identify any difference in patient-reported outcome measures between surgically and non-surgically treated patients. The vast majority of patients treated surgically had complete proximal hamstring avulsions with ≥ 2 cm of retraction. We conclude that to obtain an evidence-based treatment algorithm for proximal hamstring avulsions studies of higher scientific level are needed.

Operational strategies to manage non-elective orthopaedic surgical flows: a simulation modelling study.

OBJECTIVES: To explore the value of simulation modelling in evaluating the effects of strategies to plan and schedule operating room (OR) resources aimed at reducing time to surgery for non-elective orthopaedic inpatients at a Swedish hospital. METHODS: We applied discrete-event simulation modelling. The model was populated with real world data from a university hospital with a strong focus on reducing waiting time to surgery for patients with hip fracture. The system modelled concerned two patient groups that share the same OR resources: hip-fracture and other non-elective orthopaedic patients in need of surgical treatment. We simulated three scenarios based on the literature and interaction with staff and managers: (1) baseline; (2) reduced turnover time between surgeries by 20 min and (3) one extra OR during the day, Monday to Friday. The outcome variables were waiting time to surgery and the percentage of patients who waited longer than 24 hours for surgery. RESULTS: The mean waiting time in hours was significantly reduced from 16.2 hours in scenario 1 (baseline) to 13.3 hours in scenario 2 and 13.6 hours in scenario 3 for hip-fracture surgery and from 26.0 hours in baseline to 18.9 hours in scenario 2 and 18.5 hours in scenario 3 for other non-elective patients. The percentage of patients who were treated within 24 hours significantly increased from 86.4% (baseline) to 96.1% (scenario 2) and 95.1% (scenario 3) for hip-fracture patients and from 60.2% (baseline) to 79.8% (scenario 2) and 79.8% (scenario 3) for patients with other non-elective patients. CONCLUSIONS: Healthcare managers who strive to improve the timelines of non-elective orthopaedic surgeries may benefit from using simulation modelling to analyse different strategies to support their decisions. In this specific case, the simulation results showed that the reduction of surgery turnover times could yield the same results as an extra OR.

Waiting time to surgery is correlated with an increased risk of serious adverse events during hospital stay in patients with hip-fracture: A cohort study.

BACKGROUND: Hip fractures are common in the elderly and are associated with a high adverse event and mortality rate. Time to surgery is one of the major modifiable risk factors influencing adverse outcomes in hip-fracture patients. National guidelines and recommendations have been introduced which advocate specific time frames in which surgery should be performed i.e. within 24-48h. These time constraints have been arbitrarily set without being modelled on the linear assumption i.e. that risk increases continually over time and not within specific cut-off times. OBJECTIVES: To investigate how waiting time to surgery influenced the risk of serious adverse events in hip-fracture patients during the hospital stay and to examine how the risk increased over time. DESIGN: An observational single cohort study Participants 576 patients (72.4% females, mean [SD] age 82 [10]) years, with a hip fracture were included in the cohort study. METHODS: The outcomes of the study were the occurrence of serious adverse events during hospital stay, length of stay and one-year mortality. A structured medical record review was carried out to identify outcomes and mortality data was obtained from the Swedish National Death Registry. Waiting time to surgery was used as the exposure variable and age, sex, type of fracture, comorbidities using the American Society of Anaesthesiologists classification score and the presence of cognitive dysfunction were identified as confounders. A logistic regression analysis was performed to identify risk factors influencing outcomes. RESULTS: A total of 119 patients (20.6%) suffered 397 (range 1-5) serious adverse events during hospital stay. Every 10h of waiting time to surgery increased the risk of serious adverse events by 12% (odds ratio 1.12 [95% confidence interval 1.02-1.23]). We found no optimal cut-off times for waiting time to surgery. For every 24h of waiting time, the length of stay from surgery was increased by 0.6days (95% CI 0.1-1.1). We found no correlation between waiting time to surgery and one-year mortality. CONCLUSIONS: A large proportion of patients suffered from at least one serious adverse event after hip-fracture surgery and there are no safe limits for waiting time to surgery for hip-fracture patients. As the risk increases with every hour of waiting time, patients with higher American Society of Anesthesiologists classification scores, males and those with subtrochanteric fractures should be prioritized for surgery.

More complications with uncemented than cemented femoral stems in total hip replacement for displaced femoral neck fractures in the elderly.

Background and purpose - Total hip replacement (THR) is the preferred method for the active and lucid elderly patient with a displaced femoral neck fracture (FNF). Controversy still exists regarding the use of cemented or uncemented stems in these patients. We compared the effectiveness and safety between a modern cemented, and a modern uncemented hydroxyapatite-coated femoral stem in patients 65-79 years of age who were treated with THR for displaced FNF. Patients and methods - In a single-center, single-blinded randomized controlled trial, we included 69 patients, mean age 75 (65-79) and with a displaced FNF (Garden III-IV). 35 patients were randomized to a cemented THR and 34 to a reverse-hybrid THR with an uncemented stem. Primary endpoints were: prevalence of all hip-related complications and health-related quality of life, evaluated with EuroQol-5D (EQ-5D) index up to 2 years after surgery. Secondary outcomes included: overall mortality, general medical complications, and hip function. The patients were followed up at 3, 12, and 24 months. Results - According to the calculation of sample size, 140 patients would be required for the primary endpoints, but the study was stopped when only half of the sample size was included (n = 69). An interim analysis at that time showed that the total number of early hip-related complications was substantially higher in the uncemented group, 9 (among them, 3 dislocations and 4 periprosthetic fractures) as compared to 1 in the cemented group. The mortality and functional outcome scores were similar in the 2 groups. Interpretation - We do not recommend uncemented femoral stems for the treatment of elderly patients with displaced FNFs.

Good stability but high periprosthetic bone mineral loss and late-occurring periprosthetic fractures with use of uncemented tapered femoral stems in patients with a femoral neck fracture.

BACKGROUND AND PURPOSE: We previously evaluated a new uncemented femoral stem designed for elderly patients with a femoral neck fracture and found stable implant fixation and good clinical results up to 2 years postoperatively, despite substantial periprosthetic bone mineral loss. We now present the medium-term follow-up results from this study. PATIENTS AND METHODS: In this observational prospective cohort study, we included 50 patients (mean age 81 (70-92) years) with a femoral neck fracture. All patients underwent surgery with a cemented cup and an uncemented stem specifically designed for fracture treatment. Outcome variables were migration of the stem measured with radiostereometry (RSA) and periprosthetic change in bone mineral density (BMD), measured with dual-energy X-ray absorptiometry (DXA). Hip function and health-related quality of life were assessed using the Harris hip score (HHS) and the EuroQol-5D (EQ-5D). DXA and RSA data were collected at regular intervals up to 4 years, and data concerning reoperations and hip-related complications were collected during a mean follow-up time of 5 (0.2-7.5) years. RESULTS: At 5 years, 19 patients had either passed away or were unavailable for further participation and 31 could be followed up. Of the original 50 patients, 6 patients had suffered a periprosthetic fracture, all of them sustained after the 2-year follow-up. In 19 patients, we obtained complete RSA and DXA data and no component had migrated after the 2-year follow-up. We also found a continuous total periprosthetic bone loss amounting to a median of -19% (-39 to 2). No changes in HHS or EQ-5D were observed during the follow-up period. INTERPRETATION: In this medium-term follow-up, the stem remained firmly fixed in bone despite considerable periprosthetic bone mineral loss. However, this bone loss might explain the high number of late-occurring periprosthetic fractures. Based on these results, we would not recommend uncemented femoral stems for the treatment of femoral neck fractures in the elderly.

'Straight to bed' for hip-fracture patients: a prospective observational cohort study of two fast-track systems in 415 hips.

Delayed time to surgery is associated with an increase in medical complications and delayed rehabilitation for hip-fracture patients. The aim of this study was to evaluate whether an improved fast-tracking system for hip-fracture patients can reduce waiting time to surgery. We included a consecutive series of 415 hip-fracture patients in a prospective cohort study and followed up after 3 months. The control group (n=335) fast-tracked patients from the Accident & Emergency ward (A&E) to the orthopaedic ward and then surgery. The intervention group (n=80) fast-tracked patients directly to the orthopaedic ward and surgery, bypassing the A&E. The time to surgery was mean 3 (95% confidence interval (CI) 1-5) h shorter in the intervention group and 70 patients (88%) underwent surgery within 24h compared to 250 (75%) in the control group (P=0.015). The probability for surgery ≤ 24 h remained in favour of the intervention group after adjustments for several possible confounders. We found no difference in mortality or length of stay between the groups. The incidence of adverse events was lower in the intervention group at 3 months, 28% versus 38%, but did not reach statistical significance (P=0.08). By fast-tracking hip-fracture patients straight to the orthopaedic ward, our clinic was able to decrease the mean time from arrival to start of surgery and the majority of these patients underwent surgery within 24h. We believe that this fast-track system could be used in other hospitals, in both Sweden and abroad.