Effect of single versus multiple prophylactic antibiotic doses on prosthetic joint infections following primary total hip arthroplasty in patients with osteoarthritis at public and private hospitals in Denmark: protocol for a nationwide cross-over, cluster randomised, non-inferiority trial [The Pro-Hip-Quality Trial].

INTRODUCTION: A feared complication after total hip arthroplasty (THA) is prosthetic joint infection (PJI), associated with high morbidity and mortality. Prophylactic antibiotics can reduce the risk of PJI. However, there is no consensus on the dosages and current recommendations are based on a low evidence level. The objective is to compare the effect of a single versus multiple doses of prophylactic antibiotics administered within 24 hours on PJI. METHODS AND ANALYSIS: The study is designed as a cross-over, cluster randomised, non-inferiority trial. All clinical centres use both antibiotic practices (1 year of each intervention). All Danish orthopaedic surgery departments will be involved: Based on quality databases, 2-year cohorts of approximately 20 000 primary THAs conducted at 39 public and private hospitals, will be included. INCLUSION CRITERIA: age ≥18 years, all indications for THA except patients operated due to acute or sequelae from proximal femoral or pelvic fractures or bone tumour or metastasis. The primary outcome is PJI within 90 days after primary THA. Secondary outcomes include (1) serious adverse events, (2) potential PJI, (3) length of hospitalisation stay, (4) cardiovascular events, (5) hospital-treated infections, (6) community-based antibiotic use, (7) opioid use and (8) use of acetaminophen and non-steroidal anti-inflammatory drugs. All outcome measures will be extracted from national databases. Analyses will be based on the intention-to-treat population. Non-inferiority will be shown if the upper limit of the two-sided 95% CI for the OR is less than 1.32 for the single dose as compared with multiple doses. The results will establish best practice on antibiotic prophylaxis dosages in the future. ETHICS AND DISSEMINATION: This study has been approved by Committees on Health Research Ethics for The Capital Region of Denmark (21069108) and The Danish Medicines Agency (2021091723). All results will be presented in peer-reviewed medical journals and international conferences. TRIAL REGISTRATION NUMBER: NCT05530551.

Resilience as an Independent Predictor of Bowel Related Quality of Life After Spinal Cord Injury.

Bowel dysfunction remains a prominent priority in the rehabilitation of patients with spinal cord injuries (SCIs). However, our understanding of the factors that influence bowel-related quality of life (QoL) in this population remains limited. This study aimed to investigate the potential role of resilience, defined as an individual's capacity to cope with and adapt to adversity, as a predictor of bowel-related QoL among the patients with SCI. A cohort of adult patients with SCI who received bowel and bladder care at an outpatient clinic within a large rehabilitation hospital was identified through a prospectively collected database. Resilience was measured using the Spinal Cord Injury-Quality of Life (SCI-QOL) Resilience Short Form, whereas bowel QoL was assessed using the Irritable Bowel Syndrome-Quality of Life (IBS-QoL) questionnaire. Univariate and multivariate regression analyses were employed to identify predictors of bowel-related QoL. The examined variables included age, gender, level and completeness of injury, time since injury, hand function, resilience, and the severity of bowel dysfunction as measured using the Neurogenic Bowel Dysfunction Score (NBDS). A total of 73 patients participated in this study, with a mean age of 44.01 ± 13.43 years and comprising mostly men (n = 57, 78%). The results revealed a significant correlation between resilience scores and the total score of IBS-QoL (ρ = -0.47, p < 0.0001). The multivariate analysis demonstrated that both resilience and the severity of bowel dysfunction were significant independent predictors of bowel-related QoL, with resilience demonstrating a stronger association. Overall, this study elucidates the importance of resilience in shaping patients' perceptions of their bowel health within the SCI population. In addition to the more expected determinants of bowel-related QoL, such as the severity of bowel dysfunction, resilience emerged as a notable factor. Accordingly, integrating interventions that enhance resilience within bowel rehabilitation programs may yield improvements in patients' perceived bowel health beyond the benefits achievable through bowel function enhancement alone.

Content, face, and construct validity of the Irritable Bowel Syndrome Quality of Life (IBS-QOL) as a measure of bowel-related quality of life in spinal cord injury.

INTRODUCTION: Neurogenic bowel dysfunction is commonly encountered after a spinal cord injury (SCI), leading to a tremendous impact on quality of life (QOL). The neurogenic bowel dysfunction score (NBDS) is commonly used to measure the severity of bowel dysfunction and predict QOL. However, there is no comprehensive instrument to assess bowel-specific QOL for SCI patients. Instead, the Irritable Bowel Syndrome-Quality of Life (IBS-QOL) questionnaire evaluates the impact of bowel dysfunction on several aspects of QOL, although this questionnaire has not been validated for the SCI population. Motivated by the compelling need of instruments to accurately evaluate the QOL in patients who develope NBD after SCI, we aimed to assess the construct, content, and face validity of IBS-QOL in this population. METHODS: Adult SCI patients with at least 3 months after their injury were recruited from the outpatient clinic of a national rehabilitation hospital. Patients completed the NBDS and IBS-QOL via telephone interview or paper survey in the clinic. Content and face validity were assessed via interviews with professionals with expertise in providing chronic care for SCI, as well as a subgroup of patients. Construct validity was assessed using the hypotheses testing method. Internal consistency was assessed using Cronbach's ⍺. Factor analysis was performed to assess the dimensionality of the IBS-QOL in the SCI population. RESULTS: A total of 106 patients with a median age of 45.5 years (interquartile range: 21-79) participated in the study. The majority of the sample were men (n = 82, 77%) and had endured thoracolumbar injuries (n = 74, 71.2%). Twelve patients (seven English- and five Spanish speakers) and six professionals took part in content/face validation interviews. The median IBS-QOL total score was 15.91/100 (interquartile range: 4.55-33.14). IBS-QOL differentiated the subgroups of patients with severe bowel symptoms in terms of uneasiness, sweating, or headaches during bowel emptying (p = 0.0003), time spent on bowel emptying (p = 0.0065), flatus incontinence (p = 0.0076), and overall satisfaction with bowel function (p < 0.001), demonstrating its adequate construct validity. Interviews with the patients and professionals supported the comprehensiveness, comprehensibility, and relevance of IBS-QOL for assessment of bowel-related QOL in the SCI population. Item-level analysis of professional responses showed that 97% of questions were relevant to the construct and population of interest. Internal consistency analysis yielded a Cronbach's ⍺ of 0.9684. Exploratory factor analysis yielded six underlying factors which cumulatively accounted for 72.21% of the total variance, reflecting the dimensionality of bowel-related QOL in SCI population. DISCUSSION: IBS-QOL questionnaire is a comprehensive measure of bowel-related QOL which encompasses the concerns of SCI patients. Our findings support the content, face and construct validity of IBS-QOL as a measure of bowel-related QOL in SCI. Further studies are warranted to assess the reliability and responsiveness of IBS-QOL, and to evaluate its performance across different patient populations.

Health Care Economic Burden of Treatment and Rehabilitation for Neurogenic Lower Urinary Tract Dysfunction: A Systematic Review.

PURPOSE: The clinical, social, and economic impacts of neurogenic lower urinary tract dysfunction (NLUTD) on individuals and health care systems are thought to be immense, yet the true costs of care are unknown. The aims of this study are to illuminate the global costs related to the current state of care for NLUTD. MATERIALS AND METHODS: A systematic review of the literature was performed using MEDLINE, the National Health Service Economic Evaluation Database, and the Cochrane Specialized Urology and Incontinence Registers. Studies reporting the health care costs of NLUTD were identified. All steps of the review were performed by 2 independent reviewers. Costs were converted to 2022 U.S. dollars and reported for different categories of services. RESULTS: A total of 13 studies were included in the final review (12 from high-income economy, and 1 from an upper-middle-income economy). Routine maintenance care varied notably across studies in terms of included services. Annual supportive costs ranged from $2,039.69 to $12,219.07 with 1 study estimating lifetime costs of $112,774 when complications were considered. There were limited data on the costs of care from the patient's perspective. However, catheters and absorbent aids were estimated to be among the costliest categories of expenditure during routine care. More invasive and reconstructive treatments were associated with significant costs, ranging between $18,057 and $55,873. CONCLUSIONS: NLUTD incurs a variety of health care expenditures ranging from incontinence supplies to hospitalizations for management of complications and leads to a significant burden for health care systems over the patient's lifetime. Approaches to NLUTD that focus on functional rehabilitation and restoration, rather than on management of complications, may prove to be a less costly and more effective alternative.

A Prognostic Model for Glioblastoma Patients Treated With Standard Therapy Based on a Prospective Cohort of Consecutive Non-Selected Patients From a Single Institution.

BACKGROUND: Glioblastoma patients administered standard therapies, comprising maximal surgical resection, radiation therapy with concomitant and adjuvant temozolomide, have a variable prognosis with a median overall survival of 15-16 months and a 2-year overall survival of 30%. The aim of this study was to develop a prognostic nomogram for overall survival for glioblastoma patients treated with standard therapy outside clinical trials. METHODS: The study included 680 consecutive, non-selected glioblastoma patients administered standard therapy as primary treatment between the years 2005 and 2016 at Rigshospitalet, Copenhagen, Denmark. The prognostic model was generated employing multivariate Cox regression analysis modeling overall survival. RESULTS: The following poor prognostic factors were included in the final prognostic model for overall survival: Age (10-year increase: HR = 1.18, 95% CI: 1.08-1.28, p < 0.001), ECOG performance status (PS) 1 vs. 0 (HR = 1.30, 95% CI: 1.07-1.57, p = 0.007), PS 2 vs. 0 (HR = 2.99, 95% CI: 1.99-4.50, p < 0.001), corticosteroid use (HR = 1.42, 95% CI: 1.18-1.70, p < 0.001), multifocal disease (HR = 1.63, 95% CI: 1.25-2.13, p < 0.001), biopsy vs. resection (HR = 1.35, 95% CI: 1.04-1.72, p = 0.02), un-methylated promoter of the MGMT (O6-methylguanine-DNA methyltransferase) gene (HR = 1.71, 95% CI: 1.42-2.04, p < 0.001). The model was validated internally and had a concordance index of 0.65. CONCLUSION: A nomogram for overall survival was established. This model can be used for risk stratification and treatment planning, as well as improve enrollment criteria for clinical trials.

DNA sequencing of cytopathologically inconclusive EUS-FNA from solid pancreatic lesions suspicious for malignancy confirms EUS diagnosis.

BACKGROUND AND OBJECTIVES: EUS-FNA is inconclusive in up to 10%-15% of patients with solid pancreatic lesions (SPLs). We aimed to investigate whether supplementary genetic analyses with whole-exome sequencing add diagnostic value in patients with SPLs suspicious of malignancy but inconclusive EUS-FNA. PATIENTS AND METHODS: Thirty-nine patients, who underwent EUS-FNA of an SPL were retrospectively included. Three groups were defined: 16 (41.0%) had suspected malignancy on EUS confirmed by cytology (malignant), 13 (33.3%) had suspected malignancy on EUS but benign cytology (inconclusive), and 10 (25.6%) had benign EUS imaging and cytology (benign). Areas with the highest epithelial cell concentrations were macro-dissected from the FNA smears from each patient, and extracted DNA was used for whole-exome sequencing by next-generation sequencing of a selected gene panel including 19 genes commonly mutated in cancer. RESULTS: Pathogenic mutations in K-RAS, TP53, and PIK3CA differed significantly between the three groups (P < 0.001, P = 0.018, and P = 0.026, respectively). Pathogenic mutations in KRAS and TP53 were predominant in the inconclusive (54% and 31%, respectively) and malignant groups (81.3% and 50%, respectively) compared to the benign group (0%). Malignant and inconclusive diagnoses correlated strongly with poor overall survival (P < 0.001). CONCLUSION: Whole-exome sequencing of genes commonly mutated in pancreatic cancer may be an important adjunct in patients with SPLs suspicious for malignancy on EUS but with uncertain cytological diagnosis.

G-EYE colonoscopy is superior to standard colonoscopy for increasing adenoma detection rate: an international randomized controlled trial (with videos).

BACKGROUND AND AIMS: Colorectal cancer (CRC) is largely preventable with routine screening and surveillance colonoscopy; however, interval cancers arising from precancerous lesions missed by standard colonoscopy still occur. An increased adenoma detection rate (ADR) has been found to be inversely associated with interval cancers. The G-EYE device includes a reusable balloon integrated at the distal tip of a standard colonoscope, which flattens haustral folds, centralizes the colonoscope's optics, and reduces bowel slippage. The insufflated balloon also aims to enhance visualization of the colon during withdrawal, thereby increasing the ADR. METHODS: In this randomized, controlled, international, multicenter study (11 centers), patients (aged ≥50 years) referred to colonoscopy for screening, surveillance, or changes in bowel habits were randomized to undergo either balloon-assisted colonoscopy by using an insufflated balloon during withdrawal or standard high-definition colonoscopy. The primary endpoint was the ADR. RESULTS: One thousand patients were enrolled between May 2014 and September 2016 to undergo colonoscopy by experienced endoscopists; 803 were finally analyzed (standard colonoscopy n = 396; balloon-assisted colonoscopy n = 407). Baseline parameters were similar in both groups. Balloon-assisted colonoscopy provided a 48.0% ADR compared with 37.5% in the standard colonoscopy group (28% increase; P = .0027). Additionally, balloon-assisted colonoscopy provided for a significant increase in detection of advanced (P = .0033) flat adenomas (P < .0001) and sessile serrated adenomas/polyps (P = .0026). CONCLUSION: Balloon-assisted colonoscopy yielded a higher ADR and increased the detection of advanced, flat, and sessile serrated adenomas/polyps when compared with standard colonoscopy. Improved detection by the G-EYE device could impact the quality of CRC screening by reducing miss rates and consequently reducing interval cancer incidence. (Clinical trial registration number: NCT01917513.).