Scholarly Articles
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Item Open Access Comparative Analysis of Biological Aging and Inflammatory Profiles in Adult Spinal Deformity Patients Between Japan and the United States: A Correlative Study.(Spine, 2025-04) Yagi, Mitsuru; Hosogane, Naobumi; Ames, Christopher P; Kelly, Michael P; Smith, Justin S; Shaffrey, Christopher I; Schwab, Frank J; Lafage, Virginie; Bess, Shay; International Spine Study Group (ISSG)Study design
Retrospective matched cohort study.Objective
Understanding biological aging in adult spinal deformity (ASD) across different populations offers insights into its impact on aging and potential interventions.Summary of background data
ASD significantly impacts physiological health and may accelerate biological aging. Understanding biological aging in ASDs across different populations offers insights into ASD's impact on aging and potential interventions.Materials and methods
ASDs and norms from Japan (JP) and the U.S. (US) were included. The US norm consisted of 8,751 adults from NHNES 2017-20; the JP norm comprised 10,205 adults from health check-ups between 2020-23. Age- and gender-matched norm cohorts of 6,584 pairs (JP vs. US) were established (age: 55±13 vs. 55±14 y; female: 49 vs. 50%). ASD were age-, race- and gender-matched to norm individuals in JP (159 pairs) and the US (132 pairs). Additionally, 81 pairs of ASDs from JP and US were selected for cross-country comparisons.Results
The JP was biologically younger than the US (PhenoAge: mean difference [MD] -6.5±0.3 y; P<0.01). When comparing JP and US Asians, the JP remained biologically younger (MD: -3.1±0.7 y; P<0.01), suggesting lifestyle differences. JP ASDs were biologically older than their norms (MD: 4.2±1.7 y; P=0.02), indicating accelerated aging. However, no significant difference was observed between ASDs and the norms in the US. No significant difference in PhenoAge was found between JP and US ASDs (57.9±18.4 vs. 59.6±17.6 y; P=0.56). ASDs in both countries exhibited higher systemic inflammation, with US ASDs showing particularly elevated CRP levels (US ASD vs. norm: 2.8±8.5 vs. 0.4±0.8 mg/dL; P<0.01; JP: 0.5±1.3 vs. 0.2±0.4 mg/dL; P<0.01).Conclusions
JP are biologically younger than their US counterparts, potentially due to lifestyle factors. JP ASDs exhibit accelerated biological aging compared to the norm cohort, highlighting the impact of ASD on aging. Elevated systemic inflammation in ASDs underscores the importance of managing inflammatory processes.Item Open Access Curvature homogeneous hypersurfaces in space forms(Advances in Mathematics) Bryant, Robert; Ziller, Wolfgang; Florit, LuisWe provide a classification of curvature homogeneous hypersurfaces in space forms by classifying the ones in and . In higher dimensions, besides the isoparametric and the constant curvature ones, there is a single one in . Besides the obvious examples, we show that there exists an isolated hypersurface with a circle of symmetries and a one parameter family admitting no continuous symmetries. Outside the set of minimal points, which only exists in the case of , every example is, locally and up to covers, of this form.Item Open Access Enhancing statistical validity and power in hybrid controlled trials: A randomization inference approach with conformal selective borrowing(Proceedings of the 42nd International Conference on Machine Learning (ICML), PMLR) Zhu, Ke; Yang, Shu; Wang, XiaofeiItem Open Access Recording dynamic facial micro-expressions with a multi-focus camera array.(Biomedical optics express, 2025-02) Kreiss, Lucas; Tang, Weiheng; Balla, Ramana; Yang, Xi; Chaware, Amey; Kim, Kanghyun; Cook, Clare B; Begue, Aurelien; Dugo, Clay; Harfouche, Mark; Zhou, Kevin C; Horstmeyer, RoarkeWe present a multi-camera array for capturing dynamic high-resolution videos of the human face. Compared to traditional single-camera configurations, our array of 54 individual cameras allows stitching of high-resolution composite video frames (709 megapixels total). In our novel multi-focus strategy, each camera in the array focuses on a unique object plane to resolve non-planar surfaces at a higher resolution than a standard single-lens camera design. By overcoming the standard resolution and depth-of-field (DOF) tradeoffs, we use our array design to capture video of macroscopically curved surfaces such as the human face at a lateral resolution of 26.14 ± 5.8 µm across a composite DOF of ∼43 mm that covers the entire face (85 cm2+ FOV). Compared to a single-focus configuration, this is almost a 10-fold increase in effective DOF. We demonstrate how our multi-focus camera array can capture dynamic facial expressions at microscopic resolution with relevance in several biomedical applications.Item Open Access Beneath the surface: revealing deep-tissue blood flow in human subjects with massively parallelized diffuse correlation spectroscopy.(Neurophotonics, 2025-04) Kreiss, Lucas; Wu, Melissa; Wayne, Michael; Xu, Shiqi; McKee, Paul; Dwamena, Derrick; Kim, Kanghyun; Lee, Kyung Chul; Cowdrick, Kyle R; Liu, Wenhui; Ülkü, Arin; Harfouche, Mark; Yang, Xi; Cook, Clare; Lee, Seung Ah; Buckley, Erin; Bruschini, Claudio; Charbon, Edoardo; Huettel, Scott; Horstmeyer, RoarkeSignificance
Diffuse correlation spectroscopy (DCS) allows label-free, non-invasive investigation of microvascular dynamics deep within tissue, such as cerebral blood flow (CBF). However, the signal-to-noise ratio (SNR) in DCS limits its effective cerebral sensitivity in adults, in which the depth to the brain, through the scalp and skull, is substantially larger than in infants.Aim
Therefore, we aim to increase its SNR and, ultimately, its sensitivity to CBF through new DCS techniques.Approach
We present an in vivo demonstration of parallelized DCS (PDCS) to measure cerebral and muscular blood flow in healthy adults. Our setup employs an innovative array with hundreds of thousands single photon avalanche diodes (SPAD) in a 500×500 grid to boost SNR by averaging all independent pixel measurements. We tested this device on different total pixel counts and frame rates. A secondary, smaller array was used for reference measurements from shallower tissue at lower source-detector-separation (SDS).Results
The new system can measure pulsatile blood flow in cerebral and muscular tissue, at up to 4 cm SDS, while maintaining a similar measurement noise as compared with a previously published 32×32 PDCS system at 1.5 cm SDS. Data from a cohort of 15 adults provide strong experimental evidence for functional CBF activity during a cognitive memory task and allowed analysis of pulse markers. Additional control experiments on muscular blood flow in the forearm with a different technical configuration provide converging evidence for the efficacy of this technique.Conclusions
Our results outline successful PDCS measurements with large SPAD arrays to enable detect CBF in human adults. The ongoing development of SPAD camera technology is expected to result in larger and faster detectors in the future. In combination with new data processing techniques, tailored for the sparse signal of binary photon detection events in SPADs, this could lead to even greater SNR increase and ultimately greater depth sensitivity of PDCS.Item Open Access Torsion-Induced Traumatic Optic Neuropathy (TITON): A physiologically relevant animal model of traumatic optic neuropathy.(PloS one, 2025-01) Ryan, Annie K; Asemota, Brooke I; Heisler-Taylor, Tyler; Mello, Claire; Rodriguez, Luis; Sponsel, William E; Racine, Julie; Rex, Tonia S; Glickman, Randolph D; Reilly, Matthew ATraumatic optic neuropathy (TON) is a common cause of irreversible blindness following head injury. TON is characterized by axon damage in the optic nerve followed by retinal ganglion cell death in the days and weeks following injury. At present, no therapeutic or surgical approach has been found to offer any benefit beyond observation alone. This is due in part to the lack of translational animal models suitable for understanding mechanisms and evaluating candidate treatments. In this study, we developed a rat model of TON in which the eye is rapidly rotated, inflicting mechanical stress on the optic nerve and leading to significant visual deficits. These functional deficits were thoroughly characterized up to one week after injury using electrophysiology and immunohistochemistry. The photopic negative response (PhNR) of the light adapted full field electroretinogram (LA ffERG) was significantly altered following injury. This correlated with increased biomarkers of retinal stress, axon disruption, and cell death. Together, this evidence suggests the utility of our model for mimicking clinically relevant TON and that the PhNR may be an early diagnostic for TON. Future studies will utilize this animal model for evaluation of candidate treatments.Item Open Access Comparative Analysis of Gene Regulation in Single Cells Using CompassWan, Changxin; Qu, Yilong; Ye, Zhiyou; Zhang, Tianbei; Ma, Huifang; Chen, Ming; Hou, Wenpin; Ji, ZhichengItem Open Access Robotic radiosurgery for the treatment of pediatric arteriovenous malformations.(Journal of neurosurgery. Pediatrics, 2025-04) Kim, Lily H; Treechairusame, Teeradon; Chiang, Jennifer; White, Zachary; Jackson, Scott; Quon, Jennifer L; Appelboom, Geoffrey; Chang, Steven D; Soltys, Scott G; Guzman, Raphael; Cheshier, Samuel; Dodd, Robert L; Grant, Gerald A; Edwards, Michael SB; Gibbs, Iris CObjective
Pediatric intracranial arteriovenous malformations (AVMs) have a greater cumulative lifetime risk of rupture than those in adults. Although obliteration after radiation occurs in a dose-dependent manner, increasing radiation doses must be balanced against the risk of adverse radiation effects (AREs). The authors aimed to assess the efficacy of robotic radiosurgery for pediatric AVMs.Methods
The authors performed a retrospective review of pediatric patients with AVMs at a single institution who underwent robotic radiosurgery between 2005 and 2021 with one of 3 radiosurgery dosing schedules: 1) single-stage unfractionated (SSU), 2) single-stage fractionated (SSF), and 3) volumetrically multistaged (VMS) treatment. Cox proportional hazards regression was performed to identify predictors of AREs and obliteration.Results
Ninety-five patients with 100 intracranial AVMs were identified. Median (range) follow-up time was 4.5 (1.8-15.2) years. Forty-four (46.3%) presented with ruptured AVMs. The mean ± SD AVM volume was 10.0 ± 11.88 cm3. A plurality of AVMs were Spetzler-Martin grade III (36.2%). The overall rate of total obliteration was 52.6% (78.8% of SSU-treated, 24.2% of SSF-treated, 10% of VMS-treated patients) with a median (range) obliteration time of 3.25 (2.8-4.1) years. Partial obliteration was achieved in 23.2% of patients. In the univariate analysis, the higher obliteration rate was associated with small volume (HR 0.876, 95% CI 0.812-0.945) (p = 0.001), no prior embolization (HR 0.472, 95% CI 0.254-0.876) (p = 0.017), lower Spetzler-Martin grade (HR 0.437, 95% CI 0.320-0.597) (p ≤ 0.001), and higher single-fraction equivalent dose (HR 1.160, 95% CI 1.020-1.198) (p = 0.015). Pretreatment hemorrhage was found in 51 patients (59.6% of SSU-treated, 45.5% of SSF-treated, and 50% of VMS-treated patients). Thirteen patients experienced posttreatment hemorrhage (3.8% of SSU-treated, 12% of SSF-treated, and 60% of VMS-treated patients). AREs were found afterward in 31.6% of patients. The correlations of male sex (HR 0.447, 95% CI 0.199-1.004) (p = 0.051) and volume of brain tissue that received a single-fraction equivalent dose of 12 Gy or greater (HR 1.020, 95% CI 1.000-1.041) (p = 0.053) with AREs did not reach significance.Conclusions
SSU treatment was effective for treating smaller AVMs with an obliteration rate of 79%. Although SSF treatment was less effective in achieving total obliteration (24%), this approach significantly reduced the posttreatment hemorrhage rate by nearly 75% (46% of patients had pretreatment hemorrhage vs 12% with posttreatment hemorrhage). Unfortunately, only 10% of AVMs in the VMS cohort were obliterated and posttreatment hemorrhage rates were not reduced.Item Open Access Heiress of Fiction: Marfisa and the Macabre Legacy of Chivalric Ferrara(Renaissance Quarterly, 2024) Driscoll, KateThis essay traces parallel developments in the myths and legends associated with the historical noblewoman Marfisa d’Este (1554–1608) and her literary counterpart Marfisa, the warrior knight from chivalric romance epic poetry. Through the Este princess’s embrace of her cross-dressing fictional double in courtly performance, alongside the evolution of the figure “Marfisa bizzarra” in Italian mock epic, the intermedial afterlives of these two figures reinterpreted the women’s brazen, autonomous agency as nefarious, destructive desire. Fantasies of decadent-turned-grim Ferrara, Marfisa’s native city in poetic and historical terms, guided overlapping acts of reception and transmission between the fifteenth and twenty-first centuries.Item Open Access Style shifts in Japanese video game commentary monologues(Proceedings of the Linguistic Society of America) Christensen, Soren; Chen, YunchuanHonorific markers play an integral role in many languages, but their purpose and meaning are still widely debated. Ide (1989) claims a one-to-one relationship between social rank difference and linguistic form, but Cook (1997, 2011) proposes that honorifics are used to display a ‘disciplined self,’ which further indexes a variety of social meanings. This study examined style shifts between the honorific and plain form in Japanese video game commentary monologues. We found that instances of honorific form can be grouped into four categories regarding their contextual functions: to make an announcement, to indicate seriousness, conventionalized formulae, and to quote others. This conclusion supports Cook’s proposal.Item Open Access Simplified grammar in both languages? On scope assignment in Q-Neg sentences in English-dominant heritage Chinese speakers(Proceedings of the Linguistic Society of America) Shen, Jennifer; Chen, YunchuanQuantifier-negation (Q-Neg) sentences are sentences like ‘All teachers did not use Donald’s car,’ where a negation word and universal quantifier occur in the subject position. There are both surface scope (all>not) and inverse scope (not>all) readings in English, but only the surface scope (all>not) reading is allowed in Chinese. This study conducted a picture-matching truth value judgment experiment to examine whether English-dominant heritage Chinese speakers know the difference between English and Chinese regarding the interpretation of Q-Neg sentences. The data reveals three different groups of participants: a. participants who accepted the inverse scope reading in both languages; b. participants who rejected the inverse scope reading in both languages; c. participants who accepted the inverse scope reading in English but rejected it in Chinese. Implications regarding heritage language research will be discussed.Item Open Access Scope assignment in quantifier-negation sentences in early Korean-Chinese bilinguals’ grammars(Proceedings of the Linguistic Society of America) Chen, Yunchuan; Hester, MacQuantifier-negation sentences allow an inverse scope reading in many languages, but this phenomenon is not observed in Chinese. Building on the work of Chen and Huan (2023), this study investigates whether early Korean-Chinese bilinguals can make a distinction between Korean and Chinese in terms of the inverse scope. Employing the sentence-picture matching truth value judgment experiment from Chen and Huan (2023), we recruited a group of 23 early Korean-Chinese bilinguals and 15 monolingual Korean speakers. The experimental results aligned with those of Chen and Huan (2023), which identified three distinct groups of bilinguals. The first group permits an inverse scope reading in both Korean and Chinese, the second group prohibits it in both languages, and the third group successfully distinguishes between Korean and Chinese regarding inverse scope. These findings suggest that early bilinguals may experience long-lasting crosslinguistic influence that extends into adulthood. They may adopt either of two opposite strategies when constructing sentences, both of which can potentially minimize syntactic differences between their two languages.Item Open Access The Response(JOURNAL OF NEUROSURGERY-SPINE, 2024) Mullin, Jeffrey P; Soliman, Mohamed AR; Quiceno, Esteban; Smith, Justin S; Kelly, Michael P; Buell, Thomas J; Diebo, Bassel; Scheer, Justin K; Line, Breton; Lafage, Virginie; Lafage, Renaud; Klineberg, Eric; Kim, Han Jo; Passias, Peter G; Gum, Jeffrey L; Kebaish, Khaled; Eastlack, Robert K; Daniels, Alan H; Soroceanu, Alex; Mundis Jr, Gregory; Hostin, Richard; Protopsaltis, Themistocles S; Hamilton, D Kojo; Gupta, Munish C; Lewis, Stephen J; Schwab, Frank J; Lenke, Lawrence G; Shaffrey, Christopher I; Bess, Shay; Ames, Christopher P; Burton, DouglasItem Open Access Single-Position Prone Lateral Interbody Fusion Is Associated With Improved Radiographic and Clinical Outcomes at One Year Compared With Single-Position Lateral Interbody Fusion: A Single Institution Experience.(Spine, 2025-05) Yung, Anthony; Onafowokan, Oluwatobi O; Fisher, Max R; Cottrill, Ethan J; Prado, Isabel P; Ivasyk, Iryna; Wu, Caroline M; Parsons, Alexander W; Williamson, Tyler K; Eck, Andrew; Mir, Jamshaid; Das, Ankita; Gilsilvetti, Mateo; Tretiakov, Peter S; Shaffrey, Christopher I; Passias, Peter GItem Open Access Effect of a disposable automated suturing device on cost and operating room time in benign total laparoscopic hysterectomy procedures.(JSLS : Journal of the Society of Laparoendoscopic Surgeons, 2013-10) Hart, Stuart; Hashemi, Lobat; Sobolewski, Craig JBackground and objectives
To determine the effect of a disposable automated laparoscopic suturing device, the Endo Stitch (ES) (Covidien, Mansfield, MA, USA), on hospital cost and surgical time in patients undergoing a benign total laparoscopic hysterectomy procedure compared with the use of the da Vinci surgical system (Intuitive Surgical, Sunnyvale, CA, USA) or traditional laparoscopic suturing technique.Methods
The Premier Perspective Database (Premier, Charlotte, NC, USA) was used to identify all inpatient hospital discharges with the primary procedure of a total laparoscopic hysterectomy (International Classification of Diseases, Ninth Revision, Clinical Modification code 68.41) for benign conditions between January 1, 2009, and June 30, 2011. Patients were further categorized into 3 groups: (1) those for whom the ES was used during the laparoscopic hysterectomy procedure, (2) those for whom robotic assistance (RA) was used, and (3) those for whom neither ES nor RA (NER) was used. Multivariate analysis was performed to examine the association among the ES, RA, and NER groups with respect to hospital cost, length of stay, and surgery time. The multivariate analysis controlled for the patient's age, race, severity of illness, and comorbid conditions, as well as hospital characteristics, such as bed size, region, and teaching status.Results
A total of 9308 patients undergoing an inpatient total laparoscopic hysterectomy procedure between January 1, 2009, and June 30, 2011, were eligible for the study. The ES was used in 974 of the patients (10%), RA was used in 3971 (43%), and neither technique was used in 4363 (47%). After adjusting for confounding variables, the mean hospital cost was $1769 (P = .0332) lower, with a 42-minute (P < .001) surgery time savings, for the ES group compared with the RA group. The mean hospitalization cost for the ES group was also $634 (P < .0879) less expensive, with a 21-minute (P = .0131) surgery time savings, compared with the NER group.Conclusion
Use of a disposable automated laparoscopic suturing device, the ES, is significantly more cost-effective than the use of the da Vinci surgical system or traditional laparoscopic suturing techniques for the performance of a total laparoscopic hysterectomy procedure for benign conditions.Item Open Access A Modern Approach to Minimally Invasive Surgery and Laparoscopic Sterilization in a Chimpanzee.(Case reports in veterinary medicine, 2019-01) Newcomb, Laura K; Kruse, Meghan A; Minter, Larry J; Sobolewski, Craig JWe present the case of Ruby, a 21-year-old hand-reared chimpanzee (Pan troglodytes) who had an obstetric history significant for a premature stillborn infant that was conceived while on oral contraceptive pills, followed by a full term healthy delivery complicated by neonatal demise attributed to inappropriate maternal care. She was recommended for permanent sterilization due to her history of conception while on oral contraceptives. She underwent uncomplicated laparoscopic bilateral tubal ligation. Due to the similar anatomy to humans, human OB/GYN surgical consultants were used. The objective of this case report is to describe a modern technique for approaching and employing laparoscopic surgery in primates. Minimally invasive surgery allows for faster recovery and fewer complications, and has become the preferred approach for surgical intervention in many animals. The information presented in this case report can be expanded to benefit not only Chimpanzees but other large primate species as well. However, subtle anatomical differences among species must be recognized in order to be carried out safely.Item Open Access The impact of race on utilization of durable left ventricular assist device therapy in patients with advanced heart failure.(Journal of cardiac surgery, 2022-11) Jones, Mandisa-Maia; McElroy, Lisa M; Mirreh, Manal; Fuller, Matthew; Schroeder, Rebecca; Ghadimi, Kamrouz; DeVore, Adam; Patel, Chetan B; Black-Maier, Eric; Bartz, Raquel; Thomas, KevinBackground
Heart failure affects >6 million people in the United States alone and is most prevalent in Black patients who suffer the highest mortality risk. Yet prior studies have suggested that Black patients are less likely to receive advanced heart failure therapy. We hypothesized that Black patients would have decreased rates of durable left ventricular assist device (LVAD) implantation within our expansive heart failure program.Methods
A retrospective single-center cohort study was conducted at a single high-volume academic medical center. Patients between 18 and 85 years admitted with a diagnosis of cardiogenic shock or congestive heart failure between 1, 2013 and 12, 2017 with a left ventricular ejection fraction < 30% and inotropic dependence or need for mechanical circulatory support were included. Patients with contraindications to durable LVAD were excluded. An adjusted logistic regression model for durable LVAD implantation within 90 days of the index admission was used to determine the effect of race on durable LVAD implantation.Results
Among the 702 study patients (60.9% White, 34.1% Black), durable LVAD implantation was performed within 90 days of the index admission in 183 (26%) of the cohort. After multivariate analysis, Black patients were not found to have a statistically significant difference in durable LVAD implantation rates compared to White patients in our study (OR: 0.68 [95% confidence interval: 0.45-1.04; p: .074]).Conclusions
Black patients in our study did not have a statistically significant difference in the rate of durable LVAD implantation compared with White patients after adjustments were made for age, sex, socioeconomic, and clinical covariates. Larger prospective studies are needed to validate these findings.Item Open Access Addendum: Multi-scale predictions of massive conifer mortality due to chronic temperature rise(Nature Climate Change, 2016-11) McDowell, NG; Williams, AP; Xu, C; Pockman, WT; Dickman, LT; Sevanto, S; Pangle, R; Limousin, J; Plaut, J; Mackay, DS; Ogee, J; Domec, JC; Allen, CD; Fisher, RA; Jiang, X; Muss, JD; Breshears, DD; Rauscher, SA; Koven, CItem Open Access Risk Factors for Invasive Surgical Site Infections Among Adult Single Liver Transplant Recipients at Duke University Hospital in the Period 2015-2020.(Transplantation direct, 2024-12) Carugati, Manuela; Arif, Sana; Yarrington, Michael E; King, Lindsay Y; Harris, Matt; Evans, Kyla; Barbas, Andrew S; Sudan, Debra L; Miller, Rachel A; Alexander, Barbara DBackground
Invasive primary surgical site infections (IP-SSI) are a severe complication of liver transplant surgery. Identification of risk factors for IP-SSI is critical to IP-SSI prevention.Methods
All adult single liver transplants performed at Duke University Hospital in the period 2015-2020 were reviewed for IP-SSI occurring within 90 d of transplant. Risks for IP-SSI were identified using least absolute shrinkage and selection operator variable selection procedure. A 2-sided P value of <0.05 was considered statistically significant.Results
IP-SSI were identified in 34/470 (7.2%) adult single liver transplants. Repeat transplantation, spilt liver, Roux-en-Y biliary anastomosis, anastomotic leak, and post-transplant renal replacement therapy were positively associated with IP-SSI. IP-SSI were associated with increased length of index transplant hospitalization (24.5 versus 10.0 d, P < 0.01) and 1-y all-cause mortality (14.7% versus 4.1%, P = 0.02). Gram positive bacteria were the main pathogens (51.7%), followed by Gram negative bacteria (24.1%) and Candida (24.1%). Multidrug resistance bacteria increased over time (27.3% in 2015 versus 66.7% in 2020, P = 0.17).Conclusions
In the setting of routine antimicrobial prophylaxis and an overall low rate of IP-SSI, surgical factors were the main determinants of IP-SSI among adult liver transplant recipients. IP-SSI had a negative impact on the length of index transplant hospitalization and 1-y mortality. While the surgical factors associated with an increased risk of IP-SSI are not easily modifiable, their impact may be best contained by close clinical monitoring and tailored antimicrobial therapy.Item Open Access Bacillus Calmette-Guerin (BCG) infections following intravesical BCG immunotherapy: a systematic review protocol.(Systematic reviews, 2025-01) Monardo, Roberta; Arif, Sana; Rege, Aparna; Simon, Erin; Ledbetter, Leila; Baker, Arthur W; Stout, Jason; Carugati, ManuelaBackground
Although intravesical Bacillus Calmette-Guerin (BCG) immunotherapy usually exhibits a favorable safety profile, it can lead to the development of BCG infections, both localized and disseminated. Understanding of BCG infections following intravesical BCG immunotherapy is limited because of the lack of consensus definitions of BCG infections and limited post-instillation follow-up. We aim to perform a systematic review of the literature of BCG infections following intravesical BCG immunotherapy to elucidate the epidemiology, risk factors, and outcomes of BCG infections.Methods
Systematic review of peer-reviewed published articles that describe the treatment of one or more persons with intravesical BCG and the occurrence of BCG infections among these patients. No temporal, geographic, or demographic limitations will be applied. Animal studies will be excluded. Gray literature, editorials, and comments will be excluded. Information sources will include the following databases: MEDLINE, Embase, and Web of Science. A search concept representing BCG and intravesical administration will be applied after validation against a set of pre-selected articles. Screening and data extraction will be performed in duplicate by two independent reviewers. Disagreements will be resolved by a third independent reviewer. The methodological quality of studies will be assessed using the Mixed Methods Appraisal Tool. A narrative synthesis of the extracted data will be provided in line with the guidance from the Centre for Reviews and Dissemination. The quality of evidence for all outcomes will be judged using the Grading of Recommendations Assessment, Development, and Evaluation working group methodology.Discussion
The data generated by this review will assist clinicians in managing BCG-infected patients and inform future research efforts.Systematic review registration
In accordance with international guidelines, our systematic review protocol was submitted for registration with the International Prospective Register of Systematic Reviews (PROSPERO) on February 26, 2024.