Designing for data sharing: Considerations for advancing health equity in data management and dissemination.

Data sharing, the act of making scientific research data available to others, can accelerate innovation and discoveries, and ultimately enhance public health. The National Cancer Institute Implementation Science Centers in Cancer Control convened a diverse group of research scientists, practitioners, and community partners in three interactive workshops (May-June 2022) to identify and discuss factors that must be considered when designing research for equitable data sharing with a specific emphasis on implementation science and social, behavioral, and population health research. This group identified and operationalized a set of seven key considerations for equitable data sharing-conceptualized as an inclusive process that fairly includes the perspectives and priorities of all partners involved in and impacted by data sharing, with consideration of ethics, history, and benefits-that were integrated into a framework. Key data-sharing components particularly important for health equity included: elevating data sharing into a core research activity, incorporating diverse perspectives, and meaningfully engaging partners in data-sharing decisions throughout the project lifecycle. As the process of data sharing grows in research, it is critical to continue considering the potential positive and adverse impact of data sharing on diverse beneficiaries of health data and research.

Data sharing is a key strategy for advancing our understanding of human health and healthcare. Three interactive workshops that included researcher scientists, physicians, and community members were held by the National Cancer Institute Implementation Science Centers in Cancer Control. The group discussed ways to incorporate health equity and equitable data sharing into implementation science and social, behavioral, and population health research. Equitable data sharing is an inclusive process that considers the points of view and priorities of all partners involved with data sharing and considers ethics, history, and benefits. Seven key components emerged from these discussions and were included in a framework. The components included elevating data sharing into a core research activity, incorporating diverse perspectives, and meaningfully engaging partners in data-sharing decisions throughout the project lifecycle. As the process of data sharing grows in research, it is critical to continue considering the potential positive and negative impacts of data sharing on diverse beneficiaries of health data and research.

Bridging clinical informatics and implementation science to improve cancer symptom management in ambulatory oncology practices: experiences from the IMPACT consortium.

Objectives: To report lessons from integrating the methods and perspectives of clinical informatics (CI) and implementation science (IS) in the context of Improving the Management of symPtoms during and following Cancer Treatment (IMPACT) Consortium pragmatic trials. Materials and Methods: IMPACT informaticists, trialists, and implementation scientists met to identify challenges and solutions by examining robust case examples from 3 Research Centers that are deploying systematic symptom assessment and management interventions via electronic health records (EHRs). Investigators discussed data collection and CI challenges, implementation strategies, and lessons learned. Results: CI implementation strategies and EHRs systems were utilized to collect and act upon symptoms and impairments in functioning via electronic patient-reported outcomes (ePRO) captured in ambulatory oncology settings. Limited EHR functionality and data collection capabilities constrained the ability to address IS questions. Collecting ePRO data required significant planning and organizational champions adept at navigating ambiguity. Discussion: Bringing together CI and IS perspectives offers critical opportunities for monitoring and managing cancer symptoms via ePROs. Discussions between CI and IS researchers identified and addressed gaps between applied informatics implementation and theory-based IS trial and evaluation methods. The use of common terminology may foster shared mental models between CI and IS communities to enhance EHR design to more effectively facilitate ePRO implementation and clinical responses. Conclusion: Implementation of ePROs in ambulatory oncology clinics benefits from common understanding of the concepts, lexicon, and incentives between CI implementers and IS researchers to facilitate and measure the results of implementation efforts.

Intraoperative fluid management in adult spinal deformity surgery: variation analysis and association with outcomes.

PURPOSE: To evaluate the variability in intraoperative fluid management during adult spinal deformity (ASD) surgery, and analyze the association with complications, intensive care unit (ICU) requirement, and length of hospital stay (LOS). METHODS: Multicenter comparative cohort study. Patients ≥ 18 years old and with ASD were included. Intraoperative intravenous (IV) fluid data were collected including: crystalloids, colloids, crystalloid/colloid ratio (C/C), total IV fluid (tIVF, ml), normalized total IV fluid (nIVF, ml/kg/h), input/output ratio (IOR), input-output difference (IOD), and normalized input-output difference (nIOD, ml/kg/h). Data from different centers were compared for variability analysis, and fluid parameters were analyzed for possible associations with the outcomes. RESULTS: Seven hundred ninety-eight patients with a median age of 65.2 were included. Among different surgical centers, tIVF, nIVF, and C/C showed significant variation (p < 0.001 for each) with differences of 4.8-fold, 3.7-fold, and 4.9-fold, respectively. Two hundred ninety-two (36.6%) patients experienced at least one in-hospital complication, and ninety-two (11.5%) were IV fluid related. Univariate analysis showed significant relations for: LOS and tIVF (ρ = 0.221, p < 0.001), IOD (ρ = 0.115, p = 0.001) and IOR (ρ = -0.138, p < 0.001); IV fluid-related complications and tIVF (p = 0.049); ICU stay and tIVF, nIVF, IOD and nIOD (p < 0.001 each); extended ICU stay and tIVF (p < 0.001), nIVF (p = 0.010) and IOD (p < 0.001). Multivariate analysis controlling for confounders showed significant relations for: LOS and tIVF (p < 0.001) and nIVF (p = 0.003); ICU stay and IOR (p = 0.002), extended ICU stay and tIVF (p = 0.004). CONCLUSION: Significant variability and lack of standardization in intraoperative IV fluid management exists between different surgical centers. Excessive fluid administration was found to be correlated with negative outcomes. LEVEL OF EVIDENCE: III.

Incremental Increase in Hospital Length of Stay Due to Complications of Surgery for Adult Spinal Deformity.

STUDY DESIGN: Retrospective Cohort Study. OBJECTIVES: Length of Stay (LOS) and resource utilization are of primary importance for hospital administration. This study aimed to understand the incremental effect of having a specific complication on LOS among ASD patients. METHODS: A retrospective examination of prospective multicenter data utilized patients without a complication prior to discharge to develop a patient-adjusted and surgery-adjusted predictive model of LOS among ASD patients. The model was later applied to patients with at least 1 complication prior to discharge to investigate incremental effect of each identified complication on LOS vs the expected LOS. RESULTS: 571/1494 (38.2%) patients experienced at least 1 complication before discharge with a median LOS of 7 [IQR 5 to 9]. Univariate analysis demonstrated that LOS was significantly affected by patients' demographics (age, CCI, sex, disability, deformity) and surgical strategy (invasiveness, fusion length, posterior MIS fusion, direct decompression, osteotomy severity, IBF use, EBL, ASA, ICU stay, day between stages, Date of Sx). Using patients with at least 1 complication prior discharge and compared to the patient-and-surgery adjusted prediction, having a minor complication increased the expected LOS by 0.9 day(s), a major complication by 3.9 days, and a major complication with reoperation by 6.3 days. CONCLUSION: Complications following surgery for ASD correction have different, but predictable impact on LOS. Some complications requiring minimal intervention are associated with significant and substantial increases in LOS, while complications with significant impact on patient quality of life may have no influence on LOS.

The T4-L1-Hip Axis: Sagittal Spinal Realignment Targets in Long-Construct Adult Spinal Deformity Surgery: Early Impact.

BACKGROUND: Our understanding of the relationship between sagittal alignment and mechanical complications is evolving. In normal spines, the L1-pelvic angle (L1PA) accounts for the magnitude and distribution of lordosis and is strongly associated with pelvic incidence (PI), and the T4-pelvic angle (T4PA) is within 4° of the L1PA. We aimed to examine the clinical implications of realignment to a normal L1PA and T4-L1PA mismatch. METHODS: A prospective multicenter adult spinal deformity registry was queried for patients who underwent fixation from the T1-T5 region to the sacrum and had 2-year radiographic follow-up. Normal sagittal alignment was defined as previously described for normal spines: L1PA = PI × 0.5 - 21°, and T4-L1PA mismatch = 0°. Mechanical failure was defined as severe proximal junctional kyphosis (PJK), displaced rod fracture, or reoperation for junctional failure, pseudarthrosis, or rod fracture within 2 years. Multivariable nonlinear logistic regression was used to define target ranges for L1PA and T4-L1PA mismatch that minimized the risk of mechanical failure. The relationship between changes in T4PA and changes in global sagittal alignment according to the C2-pelvic angle (C2PA) was determined using linear regression. Lastly, multivariable regression was used to assess associations between initial postoperative C2PA and patient-reported outcomes at 1 year, adjusting for preoperative scores and age. RESULTS: The median age of the 247 included patients was 64 years (interquartile range, 57 to 69 years), and 202 (82%) were female. Deviation from a normal L1PA or T4-L1PA mismatch in either direction was associated with a significantly higher risk of mechanical failure, independent of age. Risk was minimized with an L1PA of PI × 0.5 - (19° ± 2°) and T4-L1PA mismatch between -3° and +1°. Changes in T4PA and in C2PA at the time of final follow-up were strongly associated (r2 = 0.96). Higher postoperative C2PA was independently associated with more disability, more pain, and worse self-image at 1 year. CONCLUSIONS: We defined sagittal alignment targets using L1PA (relative to PI) and the T4-L1PA mismatch, which are both directly modifiable during surgery. In patients undergoing long fusion to the sacrum, realignment based on these targets may lead to fewer mechanical failures. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Necessity of posterior osteotomies for mild flexible cervical deformity correction.

OBJECTIVE: Correction of mild flexible cervical deformity (CD) via the posterior approach has been described with and without the use of posterior osteotomies (POs), despite a lack of clarity regarding their necessity or risks. The purpose of this study was to determine whether the use of POs when correcting mild flexible CD leads to improved clinical or radiographic outcomes, as well as defining the relative risks in utilizing them. METHODS: A prospective multicenter registry of operative CD patients was analyzed. Inclusion criteria were cervical kyphosis > 10°, cervical scoliosis > 10°, cervical sagittal vertical axis (cSVA) > 4 cm, or chin-brow vertical angle > 25°. Mild deformity was defined by a cSVA of 3-5 cm and/or kyphosis < 15°. Flexibility was defined by a C2-7 angular change > 5° on preoperative flexion/extension radiographs. Patients who received a posterior column osteotomy (PCO) (Ames grades 1 and 2) were compared with patients who did not undergo a PCO (noPCO) as well as those who underwent a three-column osteotomy (3CO) (Ames grades 3-6). RESULTS: Ninety-five patients (33 PCO, 49 noPCO, 13 3CO) met the inclusion criteria. Both the number of levels fused (9.2 vs 7.7, p = 0.001) and the estimated blood loss (EBL) (1027 vs 486 mL, p = 0.012) were higher in the PCO cohort. Patients in the noPCO group were more likely to have a cervical apex of kyphosis (71.1%, p = 0.046), while those undergoing 3COs were more likely to have a thoracic apex (58.3%, p = 0.005). Preoperative cSVA (PCO vs noPCO: 45.4 vs 37.9 cm, p = 0.084), T1 slope (32.5° vs 29.6°, p = 0.376), C2-7 lordosis (-8.9° vs -9.2°, p = 0.942), and modified Japanese Orthopaedic Association (mJOA) score (13.4 vs 13.5, p = 0.854) were similar; however, both Neck Disability Index (NDI) (55.6 vs 42, p = 0.002) and numeric rating scale (NRS) neck (7.2 vs 5.8, p = 0.028) scores were higher in the PCO group before surgery. When adjusting for the use of an anterior approach, there was no significant difference in 1-year postoperative cSVA (35.7 and 35.6 cm, respectively; p = 0.969), C2-7 lordosis (13.7° and 10.1°, respectively; p = 0.393), and patient-reported outcome measures (NRS, NDI, and mJOA) between the PCO and noPCO groups. Two-year radiographic outcomes were largely similar, except for C2 slope, which was higher in the PCO group (29.1° vs 18°, p = 0.026). The overall complication rates progressively increased with more complex osteotomy use (noPCO 68.8% vs PCO 71.9% vs 3CO 75%) but did not reach significance (p = 0.063). CONCLUSIONS: The use of POs for mild flexible adult CD may not be necessary to achieve desirable radiographic correction. They are associated with greater EBL and fusion burden. Further studies are needed to fully delineate the risks of adverse events for various types of osteotomies.

The Conceptualization and Derivation of the Cervical Lordosis Distribution Index.

SUMMARY OF BACKGROUND DATA: Yilgor et al developed the lumbar Lordosis Distribution Index to individualize the pelvic mismatch to each patient's pelvic incidence. The cervical lordosis distribution in relation to its apex has not been characterized. OBJECTIVE: Tailor correction of cervical deformity by incorporating the cervical apex into a distribution index(CLDI) to maximize clinical outcomes while lowering rates of junctional failure. STUDY DESIGN/SETTING: Retrospective cohort. METHODS: CD patients with complete 2Y data were included. Optimal outcome is defined by no DJF, and meeting Virk et al Good Clinical Outcome Criteria:[Meeting 2 of 3: 1)an NDI<20 or meeting MCID, 2)mJOA>=14, 3)an NRS-Neck<=5 or improved by 2 or more points]. C2-T2 lordosis was divided into cranial (C2 to apex) and caudal (apex to T2) arches postoperatively. A cervical lordosis distribution index(CLDI) was developed by dividing the cranial lordotic arch(C2 to apex) by the total segment(C2-T2) and multiplying by 100. Cross-tabulations developed categories for CLDI producing the highest chi-square values for achieving Optimal Outcome at two years and outcomes were assessed by multivariable analysis controlling for significant confounders. RESULTS: 84 CD patients were included. Cervical apex distribution postoperatively was: 1% C3, 42% C4, 30% C5, 27% C6. Mean cervical LDI was 117±138. Mean cranial lordosis was 23.2±12.5°. Using cross-tabulations, a CLDI between 70 and 90 was defined as 'Aligned'. Chi-square test revealed significant differences among CLDI categories for DJK, DJF, Good Clinical Outcome, and Optimal Outcome(all P<0.05). Patients aligned in CLDI were less likely to develop DJK(OR: 0.1, [0.01-0.88]), more like to achieve GCO (OR: 3.9, [1.2-13.2]) and Optimal Outcome (OR: 7.9, [2.1-29.3] at two years. Patients aligned in CLDI developed DJF at a rate of 0%. CONCLUSION: The cervical lordosis distribution index, classified through the cranial segment, takes each unique cervical apex into account and tailors correction to the patient in order to better achieve good clinical outcomes and minimize catastrophic complications following cervical deformity surgery. LEVEL OF EVIDENCE: III.

Content validity index for the readiness for hospital discharge scale in the skilled nursing facility setting.

OBJECTIVES: The purpose of this study was to determine the appropriateness of using the Readiness for Hospital Discharge Scale (RHDS) in the skilled nursing facility (SNF) setting as a discharge outcome measure. METHODS: Six experts consisting of nurses and physical therapists from two different SNFs in the Midwest were selected to participate in the study. The content validity of the scale was determined by using item and scale content validity index scores to determine the appropriateness of the scale in the SNF setting. RESULTS: The scale content validity index score for the RHDS was 0.96 with an item content validity index score range of 0.83 to 1.0. Kendall's Coefficient of Concordance was 0.278 and the statistical significance had a p-value of 0.031. CONCLUSIONS: The results of this study indicate that the RHDS has good content validity and is an appropriate measure to determine patient discharge readiness in the SNF setting.

Thoracolumbar fusions for adult lumbar deformity show superior QALY gain and lower costs compared with upper thoracic fusions.

PURPOSE: Adult spinal deformity (ASD) patients with sagittal plane deformity (N) or structural lumbar/thoraco-lumbar (TL) curves can be treated with fusions stopping at the TL junction or extending to the upper thoracic (UT) spine. This study evaluates the impact on cost/cumulative quality-adjusted life year (QALY) in patients treated with TL vs UT fusion. METHODS: ASD patients with > 4-level fusion and 2-year follow-up were included. Index and total episode-of-care costs were estimated using average itemized direct costs obtained from hospital records. Cumulative QALY gained were calculated from preoperative to 2-year postoperative change in Short Form Six-Dimension (SF-6D) scores. The TL and UT groups comprised patients with upper instrumented vertebrae (UIV) at T9-T12 and T2-T5, respectively. RESULTS: Of 566 patients with type N or L curves, mean age was 63.2 ± 12.1 years, 72% were female and 93% Caucasians. Patients in the TL group had better sagittal vertical axis (7.3 ± 6.9 vs. 9.2 ± 8.1 cm, p = 0.01), lower surgical invasiveness (- 30; p < 0.001), and shorter OR time (- 35 min; p = 0.01). Index and total costs were 20% lower in the TL than in the UT group (p < 0.001). Cost/QALY was 65% lower (492,174.6 vs. 963,391.4), and 2-year QALY gain was 40% higher, in the TL than UT group (0.15 vs. 0.10; p = 0.02). Multivariate model showed TL fusions had lower total cost (p = 0.001) and higher QALY gain (p = 0.03) than UT fusions. CONCLUSION: In Schwab type N or L curves, TL fusions showed lower 2-year cost and improved QALY gain without increased reoperation rates or length of stay than UT fusions. LEVEL OF EVIDENCE: III.

Ultrasound- and fluoroscopy-guided percutaneous transhepatic shunt attenuation using a vascular plug in a complex canine intrahepatic portosystemic shunt.

A 5-month-old Pembroke Welsh corgi dog was presented with a 3-month history of lethargy, inappetence, polyuria/polydipsia, and neurological signs. A diagnosis of a complex multiple intrahepatic portosystemic shunt (IHPSS) configuration was obtained by computed tomography angiogram, abdominal ultrasonography, and perioperative fluoroscopic angiography. The IHPSS was successfully attenuated by shunt embolization with a vascular plug, using a direct percutaneous hepatic approach under ultrasonographic and fluoroscopic guidance. Long-term (4 y) follow-up revealed resolution of all clinical signs. The owner elected to continue dietary modification and lactulose treatment indefinitely and the outcome was considered good. Key clinical message: Direct percutaneous hepatic approach could be considered for IHPSS attenuation in select cases where traditional transvenous approach access is considered challenging.

Atténuation percutanée trans-hépatique guidée par échographie et fluoroscopie d'un shunt porto-systémique intrahépatique canin complexe à l'aide d'un bouchon vasculaireUn chien Pembroke Welsh corgi âgé de 5 mois a été présenté avec des antécédents de léthargie, d'inappétence, de polyurie/polydipsie et de signes neurologiques depuis 3 mois. Un diagnostic de configuration complexe de shunt porto-systémique intrahépatique multiple (IHPSS) a été obtenu par angiographie par tomodensitométrie, échographie abdominale et angiographie fluoroscopique périopératoire. L'IHPSS a été atténué avec succès par embolisation du shunt avec un bouchon vasculaire, en utilisant une approche hépatique percutanée directe sous guidage échographique et fluoroscopique. Un suivi à long terme (4 ans) a révélé une résolution de tous les signes cliniques. Le propriétaire a choisi de poursuivre indéfiniment la modification du régime alimentaire et le traitement au lactulose et le résultat a été considéré comme bon.Message clinique clé :Une approche hépatique percutanée directe pourrait être envisagée pour l'atténuation de l'IHPSS dans certains cas où l'accès par voie trans-veineuse traditionnelle est considéré comme difficile.(Traduit par Dr Serge Messier).

Use of Hybrid Stage I to Stratify Between Single Ventricle Palliation and Biventricular Repair.

Background: Hybrid stage I palliation (HS1P) has been utilized for patients with single ventricle (SV) congenital heart disease (CHD). To date, reports on the use of HS1P for other indications including biventricular (BiV) CHD have been limited. Methods: We performed a single-center retrospective cohort study of patients who underwent HS1P with an anticipated physiologic outcome of BiV repair, or with an undetermined SV versus BiV outcome. Patient characteristics and outcomes from birth through definitive repair or palliation were collected and reported with descriptive statistics. Results: Nineteen patients underwent HS1P with anticipated BiV repair. Extracardiac and intracardiac risk factors (ICRF) were common. Ultimately, 13 (68%) patients underwent BiV repair, 1 (5%) underwent SV palliation, and 5 (26%) died prior to further palliation or repair. Resolution of ICRF tracked with BiV outcome (6/6, 100%), persistence of ICRF tracked with SV outcome or death (3/3, 100%). Twenty patients underwent HS1P with an undetermined outcome. Ultimately, 13 (65%) underwent BiV repair, 6 (30%) underwent SV palliation, and 1 (5%) underwent transplant. There were no deaths. Intracardiac risk factors were present in 15 of 20 patients (75%); BiV repair only occurred when all ICRF resolved (67%). Post-HS1P complications and reinterventions occurred frequently in both groups, through all phases of care. Conclusions: Hybrid stage 1 palliation can be used to defer BiV repair and to delay decision between SV palliation and BiV repair. Resolution of ICRF was associated with ultimate outcome. In this high-risk group, complications are common, and mortality especially in the marginal BiV patient is high.

Impact of Prior Cervical Fusion on Patients Undergoing Thoracolumbar Deformity Correction.

STUDY DESIGN: Retrospective analysis of prospectively collected data. OBJECTIVE: Evaluate the impact of prior cervical constructs on upper instrumented vertebrae (UIV) selection and postoperative outcomes among patients undergoing thoracolumbar deformity correction. BACKGROUND: Surgical planning for adult spinal deformity (ASD) patients involves consideration of spinal alignment and existing fusion constructs. METHODS: ASD patients with (ANTERIOR or POSTERIOR) and without (NONE) prior cervical fusion who underwent thoracolumbar fusion were included. Demographics, radiographic alignment, patient-reported outcome measures (PROMs), and complications were compared. Univariate and multivariate analyses were performed on POSTERIOR patients to identify parameters predictive of UIV choice and to evaluate postoperative outcomes impacted by UIV selection. RESULTS: Among 542 patients, with 446 NONE, 72 ANTERIOR, and 24 POSTERIOR patients, mean age was 64.4 years and 432 (80%) were female. Cervical fusion patients had worse preoperative cervical and lumbosacral deformity, and PROMs (P<0.05). In the POSTERIOR cohort, preoperative LIV was frequently below the cervicothoracic junction (54%) and uncommonly (13%) connected to the thoracolumbar UIV. Multivariate analyses revealed that higher preoperative cervical SVA (coeff=-0.22, 95%CI=-0.43--0.01, P=0.038) and C2SPi (coeff=-0.72, 95%CI=-1.36--0.07, P=0.031), and lower preoperative thoracic kyphosis (coeff=0.14, 95%CI=0.01-0.28, P=0.040) and thoracolumbar lordosis (coeff=0.22, 95%CI=0.10-0.33, P=0.001) were predictive of cranial UIV. Two-year postoperatively, cervical patients continued to have worse cervical deformity and PROMs (P<0.05) but had comparable postoperative complications. Choice of thoracolumbar UIV below or above T6, as well as the number of unfused levels between constructs, did not affect patient outcomes. CONCLUSIONS: Among patients who underwent thoracolumbar deformity correction, prior cervical fusion was associated with more severe spinopelvic deformity and PROMs preoperatively. The choice of thoracolumbar UIV was strongly predicted by their baseline cervical and thoracolumbar alignment. Despite their poor preoperative condition, these patients still experienced significant improvements in their thoracolumbar alignment and PROMs after surgery, irrespective of UIV selection. LEVEL OF EVIDENCE: IV.

Durability of substantial clinical benefit leading to optimal outcomes in adult spinal deformity corrective surgery: a minimum 5-year analysis.

OBJECTIVE: The objective was to evaluate factors associated with the long-term durability of outcomes in adult spinal deformity (ASD) patients. METHODS: Operative ASD patients fused from at least L1 to the sacrum with baseline (BL) to 5-year (5Y) follow-up were included. Substantial clinical benefit (SCB) in Oswestry Disability Index (ODI), numeric rating scale (NRS)-back, NRS-leg, and Scoliosis Research Society (SRS)-22r scores and physical component score were assessed on the basis of previously published values. Factors were evaluated on the basis of meeting optimal outcomes (OO) at 2 years (2+) and 5 years (5+). Furthermore, 2+ patients were isolated and evaluated on the basis of meeting OO at 5 years (2+5+) or not at 5 years (2+5-). OO were defined as follows: no reoperation, major mechanical failure, proximal junctional failure, and meeting either 1) SCB in terms of ODI score (decrease > 18.8) or 2) ODI < 15 and SRS-22r total > 4.5. RESULTS: In total, 330 ASD patients met the inclusion criteria, with 45.5% meeting SCB for ODI at 2 years, while 46.0% met SCB at 5 years; 79% of those who achieved 2-year (2Y) SCB went on to achieve 5Y SCB. This rate was lower for OO, with 41% achieving 2Y OO (2+), while 37% met 5Y OO (5+) and 80% of 2+ patients had durable outcomes until 5+ (32% of the total cohort). Of the patient factors, frailty was significantly different among groups at 2 years, while comorbidity burden was significantly different at 5 years and the combination thereof differed in those with durable outcomes. Those who regained their level of activity postoperatively had 4 times higher odds of maintaining OO from 2 years to 5 years (p < 0.05). Osteoporosis rates, although equivocal at BL, were higher at the last follow-up in those who met 2Y OO but failed to meet 5Y OO. The odds of achieving OO at 5 years in 2+ patients decreased by 47% for each additional comorbidity and decreased by 74% in those who had lower-extremity paresthesias at BL (both p < 0.05). Controlling for patient factors and BL disability found fewer levels fused, decreased correction of sagittal vertical axis, and increased correction of pelvic incidence-lumbar lordosis mismatch to be predictive of maintaining 2Y OO until 5 years (p < 0.05). CONCLUSIONS: SCB was met in 46% of ASD patients at 5 years. The durability of OO was seen in a third of patients until 5 years postoperatively. Higher rates of medical complications were seen in those who failed to achieve and maintain OO until 5 years. Frailty and comorbidity burden were significant factors associated with the achievement and durability of OO until 5 years.

Community-Based Participatory Research and System Dynamics Modeling for Improving Retention in Hypertension Care.

Importance: The high prevalence of hypertension calls for broad, multisector responses that foster prevention and care services, with the goal of leveraging high-quality treatment as a means of reducing hypertension incidence. Health care system improvements require stakeholder input from across the care continuum to identify gaps and inform interventions that improve hypertension care service, delivery, and retention; system dynamics modeling offers a participatory research approach through which stakeholders learn about system complexity and ways to model sustainable system-level improvements. Objective: To assess the association of simulated interventions with hypertension care retention rates in the Nigerian primary health care system using system dynamics modeling. Design, Setting, and Participants: This decision analytical model used a participatory research approach involving stakeholder workshops conducted in July and October 2022 to gather insights and inform the development of a system dynamics model designed to simulate the association of various interventions with retention in hypertension care. The study focused on the primary health care system in Nigeria, engaging stakeholders from various sectors involved in hypertension care, including patients, community health extension workers, nurses, pharmacists, researchers, administrators, policymakers, and physicians. Exposure: Simulated intervention packages. Main Outcomes and Measures: Retention rate in hypertension care at 12, 24, and 36 months, modeled to estimate the effectiveness of the interventions. Results: A total of 16 stakeholders participated in the workshops (mean [SD] age, 46.5 [8.6] years; 9 [56.3%] male). Training of health care workers was estimated to be the most effective single implementation strategy for improving retention in hypertension care in Nigeria, with estimated retention rates of 29.7% (95% CI, 27.8%-31.2%) at 12 months and 27.1% (95% CI, 26.0%-28.3%) at 24 months. Integrated intervention packages were associated with the greatest improvements in hypertension care retention overall, with modeled retention rates of 72.4% (95% CI, 68.4%-76.4%), 68.1% (95% CI, 64.5%-71.7%), and 67.1% (95% CI, 64.5%-71.1%) at 12, 24, and 36 months, respectively. Conclusions and Relevance: This decision analytical model study showed that community-based participatory research could be used to estimate the potential effectiveness of interventions for improving retention in hypertension care. Integrated intervention packages may be the most promising strategies.

A mixed-methods approach to assessing implementers' readiness to adopt digital health interventions (RADHI).

BACKGROUND: Despite being the primary setting for HIV prevention among men who have sex with men (MSM) since the start of the epidemic, community-based organizations (CBOs) struggle to reach this historically stigmatized and largely hidden population with face-to-face interventions. HIV researchers have readily turned to the internet to deliver critical HIV education to this group, with evidence of high effectiveness and acceptability across studies. However, implementation outside of research contexts has been limited and not well studied. We aimed to assess HIV CBOs' readiness to adopt digital health interventions and identify contextual factors that may contribute to differing levels of readiness. METHODS: We recruited 22 CBOs across the US through a pragmatic request-for-proposals process to deliver Keep It Up! (KIU!), an evidence-based eHealth HIV prevention program. We used mixed methods to examine CBO readiness to adopt digital health interventions (RADHI). Before implementation, CBO staff completed a 5-item RADHI scale (scored 0-4) that demonstrated concurrent and predictive validity. We interviewed CBO staff using semi-structured questions guided by the Consolidated Framework for Implementation Research and compared RADHI score groups on determinants identified from the interviews. RESULTS: Eighty-five staff (range = 1-10 per CBO) completed the RADHI. On average, CBOs reported moderate-to-great readiness (2.74) to adopt KIU!. High RADHI CBOs thought KIU! was a top priority and an innovative program complementary to their existing approaches for their clients. Low RADHI CBOs expressed concerns that KIU! could be a cultural mismatch for their clients, was lower priority than existing programs and services, relied on clients' own motivation, and might not be suitable for clients with disabilities. Value, appeal, and limitations did not differ by RADHI group. CONCLUSIONS: While HIV CBOs are excited for the opportunities and advantages of digital interventions, additional pre-implementation and implementation support may be needed to increase perceived value and usability for different client populations. Addressing these limitations is critical to effective digital prevention interventions for HIV and other domains such as mental health, chronic disease management, and transitions in care. Future research can utilize our novel, validated measure of CBOs' readiness to adopt digital health interventions. TRIAL REGISTRATION: NCT03896776, clinicaltrials.gov, 1 April 2019.

Radiographic Alignment in Deformity Patients Treated With Personalized Interbody Devices: Early Experience From the COMPASS Registry.

BACKGROUND: Literature supports the need for improved techniques to achieve spinopelvic alignment and reduce complication rates in patients with adult spinal deformity (ASD). Personalized interbody devices were developed to address this need and are under evaluation in the multicenter Clinical Outcome Measures in Personalized aprevo (circle R superscript) Spine Surgery (COMPASS (TM suprascript) registry. This report presents interim COMPASS pre- and postoperative sagittal alignment results and complication rates for a subcohort of COMPASS patients diagnosed and surgically treated for spinal deformity. METHODS: COMPASS is a postmarket observational registry of patients enrolled either before or after index surgery and then followed prospectively for 24 months. Sagittal alignment was assessed with SRS-Schwab modifiers for pelvic incidence minus lumbar lordosis, pelvic tilt, and T1 pelvic angle. Summed SRS-Schwab modifiers were utilized to assign overall deformity status as mild, moderate, or severe. Complications were extracted from patient medical records. RESULTS: The study included 67 patients from 9 centers. Preoperative severe deformity was observed in 66% of patients. Index surgeries included implantation of a median of 2 personalized interbody devices by anterior, lateral, or transforaminal approaches and with a median of 8 posteriorly instrumented levels. Overall postoperative sagittal alignment improved with a significant decrease in the mean sum of SRS-Schwab modifiers that correlated strongly to improvements in pelvic incidence minus lumbar lordosis. Among 44 patients with preoperative severe overall deformity, 16 improved to moderate and 9 to mild deformity. Complications occurred for 13 patients (19.4%), including 1 mechanical complication requiring revision 9 months after surgery and none related to personalized interbody devices. CONCLUSIONS: This study demonstrates that ASD patients whose treatment included personalized interbody devices can obtain favorable postoperative alignment status comparable to published results and with no complications related to the personalized interbody devices. CLINICAL RELEVANCE: This study contributes to growing evidence that personalized interbody devices contribute to improved sagittal alignment in ASD patients by directly adjusting the orientation of adjacent vertebra.

Predictability in Achieving Target Intervertebral Lordosis Using Personalized Interbody Implants.

BACKGROUND: Lumbar lordosis distribution has become a pivotal factor in re-establishing the foundational alignment of the lumbar spine. This can directly influence overall sagittal alignment, leading to improved long-term outcomes for patients. Despite the wide availability of hyperlordotic stock cages intended to achieve optimal postoperative alignment, there is a lack of correlation between the lordotic shape of a cage and the resultant intervertebral alignment. Recently, personalized spine surgery has witnessed significant advancements, including 3D-printed personalized interbody implants, which are customized to the surgeon's treatment and alignment goals. This study evaluates the reliability of 3D-printed patient-specific interbody implants to achieve the planned postoperative intervertebral alignment. METHODS: This is a retrospective study of 217 patients with spinal deformity or degenerative conditions. Patients were included if they received 3D-printed personalized interbody implants. The desired intervertebral lordosis (IVL) angle was prescribed into the device design for each personalized interbody (IVL goal). Standing postoperative radiographs were measured, and the IVL offset was calculated as IVL achieved minus IVL goal. RESULTS: In this patient population, 365 personalized interbodies were implanted, including 145 anterior lumbar interbody fusions (ALIFs), 99 lateral lumbar interbody fusions (LLIFs), and 121 transforaminal lumbar interbody fusions. Among the 365 treated levels, IVL offset was 1.1° ± 4.4° (mean ± SD). IVL was achieved within 5° of the plan in 299 levels (81.9%). IVL offset depended on the approach of the lumbar interbody fusion and was achieved within 5° for 85.9% of LLIF, 82.6% of transforaminal lumbar interbody fusions and 78.6% of ALIFs. Ten levels (2.7%) missed the planned IVL by >10°. ALIF and LLIF levels in which the plan was missed by more than 5° tended to be overcorrected. CONCLUSIONS: This study supports the use of 3D-printed personalized interbody implants to achieve planned sagittal intervertebral alignment. CLINICAL RELEVANCE: Personalized interbody implants can consistently achieve IVL goals and potentially impact foundational lumbar alignment.

Mismatch Between Pelvic Incidence and Lumbar Lordosis After Personalized Interbody Fusion: The Importance of Preoperative Planning and Alignment in Degenerative Spine Diseases.

BACKGROUND: Emerging data have highlighted the significance of planning and aligning total and segmental lumbar lordosis with pelvic morphology when performing short-segment fusion with the goal of reducing the risk of adjacent segment disease while also decreasing spine-related disability. This study evaluates the impact of personalized interbody implants in restoring pelvic incidence-lumbar lordosis (PI-LL) mismatch compared with a similar study using stock interbody implants. METHODS: This multicenter retrospective analysis assessed radiographic pre- and postoperative spinopelvic alignment (PI-LL) in patients who underwent 1- or 2-level lumbar fusions with personalized interbody implants for degenerative (nondeformity) indications. The aim was to assess the incidence of malalignment (PI-LL ≥ 10°) both before and after fusion surgery and to determine the rate of alignment preservation and/or correction in this population. RESULTS: There were 135 patients included in this study. Of 83 patients who were aligned preoperatively, alignment was preserved in 76 (91.6%) and worsened in 7 (8.4%). Among the 52 preoperatively malaligned patients, alignment was restored in 23 (44.2%), and 29 (55.8%) were not fully corrected. Among patients who were preoperatively aligned, there was no statistically significant difference in either the "preserved" or "worsened" groups between stock devices and personalized interbody devices. In contrast, among patients who were preoperatively malaligned, there was a statistically significant increase in the "restored" group (P = 0.046) and a statistically significant decrease in the "worsened" groups in patients with personalized interbodies compared with historical stock device data (P < 0.05). CONCLUSIONS: Compared with a historical cohort with stock implants, personalized interbody implants in short-segment fusions have shown a statistically significant improvement in restoring patients to normative PI-LL. Using 3-dimensional preoperative planning combined with personalized implants provides an important tool for planning and achieving improvement in spinopelvic parameters.