Multicenter Longitudinal Cohort Study Research Articles

Incidence and Predictors of Subsequent Surgery following ACL Reconstruction: A 6-Year Cohort Follow-up Study

Objectives:Subsequent surgeries after ACL reconstruction are known to negatively affect patient satisfaction and outcomes. Previous studies have identified risk factors for subsequent operations after ACL reconstruction, but few studies have identified factors which increase the risk for subsequent specific procedures related to meniscus and articular cartilage.The purpose of this study was two-fold: 1) to report the incidence and types of subsequent surgeries which occur in a cohort of ACL reconstructed patients 6 years following their index ACL reconstruction; and, 2) to predict which variables (i.e. patient demographic and surgical) may influence the incidence of a patient having a subsequent meniscus or articular cartilage related surgery following their index ACL reconstruction.Methods:This was a multicenter longitudinal prospective cohort study design. Each participant completed a questionnaire that included baseline demographics, injury descriptors, sports participation level, comorbidities, knee surgical history, and validated patient-reported outcome measures, and were followed up at 2 and 6 years. In addition, patients were also contacted to determine whether any underwent additional surgical knee procedures since baseline. Operative reports were obtained and independently read by two orthopaedic surgeons, and all procedures were categorized and recorded, along with the surgical date. If multiple procedures were done during an operation, all were recorded. Two separate logistical regression models were constructed to predict which independent variables (i.e. patient demographic and surgical) potentially influenced the incidence of a patient having a subsequent surgery following their index ACL reconstruction: model #1 examined subsequent meniscus-related surgeries on the ipsilateral knee and model #2 examined subsequent articular cartilage-related surgeries.Results:The cohort consisted of 3,276 subjects (56% male) with a median age of 23 years at the time of enrollment. Primary ACL reconstructions comprised 93% of the group, while 7% were enrolled as revision ACL reconstructions. The majority of subjects underwent bone-patellar tendon-bone (BTB) autograft reconstructions (43%), while 34% underwent hamstring autograft and 23% had allograft reconstructions. We obtained 92% (2999/3276) follow-up with regards to information on incidence and frequency of subsequent surgeries on the cohort. The remaining 8% (277/3276) were lost to follow-up. Overall, 20% (612/2999) of the cohort was documented to have had at least one subsequent surgery on the ipsilateral knee 6 years following their index ACL reconstruction. These 612 subjects encompassed 1,272 categorical procedures. The most common subsequent procedures on the ipsilateral knee were meniscus-related (n=357 procedures;11.9% of follow-up cohort), revision ACL reconstruction (226 procedures; 7.5% of cohort), arthrofibrosis-related (235 procedures; 7.8% of cohort), or articular cartilage-related (201 procedures; 6.7% of cohort). Collectively, subsequent procedures involving the medial meniscus (repairs and/or meniscectomies) occurred almost twice as frequently as the lateral meniscus (7.4% vs. 4.2%). Surprisingly, only 19 total knee arthroplasties (0.6% of cohort) were performed during this follow-up time period, at a median time of 45 months following the patient’s index ACL reconstruction. The variables that were found to be significant predictors of having a subsequent meniscal surgery on the ipsilateral knee were patients with lower age, higher baseline Marx activity level, patients who had quit smoking (compared to non-smokers), having a autograft hamstring or allograft (compared to an autograft BTB), or having a medial meniscus repair or a medial meniscus tear that was not treated at the time of index surgery. After adjusting for all other covariates, patients with an index medial meniscus repair were 4.4 times more likely to undergo a subsequent surgery related to the meniscus than patients with no initial medial meniscal pathology. The variables that were found to be significant predictors of having a subsequent surgery involving the articular cartilage (AC) were patients with higher BMI, higher baseline Marx activity level, having an autograft hamstring or allograft (compared to an autograft BTB), having a meniscus repair at the time of index surgery, or having Grade 3 or 4 AC pathology in any compartment. Specifically, if a patient has grade 4 changes in any compartment at the time of their index reconstruction, they are over 3 times more likely to have a subsequent AC-related surgery by 6 years, after controlling for all covariates (p<0.001).Conclusion:This study identified the incidence of subsequent surgeries and risk factors for having subsequent meniscus or articular cartilage related procedures over a 6-year follow up period. Identifying and understanding these risk factors is a critical step in helping to mitigate the risks to improve patient outcomes.

Rates and Predictors of Patient Underreporting of Hospitalizations During Follow-Up After Acute Myocardial Infarction: An Assessment From the TRIUMPH Study.

Many clinical investigations depend on participant self-report as a principal method of identifying health care events. If self-report is used as the trigger to collect and adjudicate medical records, any event that is not reported by the patient will be missed by the investigators, reducing the power of the study and misrepresenting the risk of its participants. We sought to determine the rates and predictors of underreporting hospitalization events during the follow-up period of a prospective study of patients hospitalized with an acute myocardial infarction. The TRIUMPH (Translational Research Investigating Underlying Disparities in Acute Myocardial Infarction Patients' Health Status) registry, a longitudinal multicenter cohort study of people with acute myocardial infarction in the United States, queried patients for hospitalization events during interviews at 1, 6, and 12 months. To validate these self-reports, medical records for all events at every hospital where the patient reported receiving care were acquired for adjudication, not just those for the reported events. Of the 4340 participants in TRIUMPH, 1209 (28%) reported at least one hospitalization. After medical records abstraction and adjudication, we identified 1086 hospitalizations from 639 participants (60.2±12 years of age, 38.2% women). Of these hospitalizations, 346 (31.9%) were underreported by the participants. Rates of underreporting ranged from 22.5% to 55.6% based on different patient characteristics. The odds of underreporting were highest for those not currently working (adjusted odds ratio, 1.66 [95% CI, 1.04-2.63]), lowest for those married (adjusted odds ratio, 0.50 [95% CI, 0.33-0.76]), and increased the longer the elapsed time between the admission and the patient's follow-up interview (adjusted odds ratio per month, 1.16 [95% CI, 1.08-1.24]). There was a substantial within-individual variation on the accuracy of reporting. Hospitalizations after acute myocardial infarction are commonly underreported in interviews and should not be used alone to determine event rates in clinical studies.

Clinical implications of serum neurofilament in newly diagnosed MS patients: A longitudinal multicentre cohort study.

BackgroundWe aim to evaluate serum neurofilament light chain (sNfL), indicating neuroaxonal damage, as a biomarker at diagnosis in a large cohort of early multiple sclerosis (MS) patients.MethodsIn a multicentre prospective longitudinal observational cohort, patients with newly diagnosed relapsing-remitting MS (RRMS) or clinically isolated syndrome (CIS) were recruited between August 2010 and November 2015 in 22 centers. Clinical parameters, MRI, and sNfL levels (measured by single molecule array) were assessed at baseline and up to four-year follow-up.FindingsOf 814 patients, 54.7% (445) were diagnosed with RRMS and 45.3% (369) with CIS when applying 2010 McDonald criteria (RRMS[2010] and CIS[2010]). After reclassification of CIS[2010] patients with existing CSF analysis, according to 2017 criteria, sNfL levels were lower in CIS[2017] than RRMS[2017] patients (9.1 pg/ml, IQR 6.2–13.7 pg/ml, n = 45; 10.8 pg/ml, IQR 7.4–20.1 pg/ml, n = 213; p = 0.036). sNfL levels correlated with number of T2 and Gd+ lesions at baseline and future clinical relapses. Patients receiving disease-modifying therapy (DMT) during the first four years had higher baseline sNfL levels than DMT-naïve patients (11.8 pg/ml, IQR 7.5-20.7 pg/ml, n = 726; 9.7 pg/ml, IQR 6.4–15.3 pg/ml, n = 88). Therapy escalation decisions within this period were reflected by longitudinal changes in sNfL levels.InterpretationAssessment of sNfL increases diagnostic accuracy, is associated with disease course prognosis and may, particularly when measured longitudinally, facilitate therapeutic decisions.FundingSupported the German Federal Ministry for Education and Research, the German Research Council, and Hertie-Stiftung.

Sputum microbiome profiles identify severe asthma phenotypes of relative stability at 12 to 18 months

Asthma is a heterogeneous disease characterized by distinct phenotypes with associated microbial dysbiosis. Our aim was to identify severe asthma phenotypes based on sputum microbiome profiles and assess their stability after 12 to 18 months. Afurther aim was to evaluate clusters' robustness after inclusion of an independent cohort of patients with mild-to-moderate asthma. In this longitudinal multicenter cohort study, sputum samples were collected for microbiome profiling from a subset of the Unbiased Biomarkers in Prediction of Respiratory Disease Outcomes adult patient cohort at baseline and after 12 to 18 months of follow-up. Unsupervised hierarchical clustering was performed by using the Bray-Curtis β-diversity measure of microbial profiles. For internal validation, partitioning around medoids, consensus cluster distribution, bootstrapping, and topological data analysis were applied. Follow-up samples were studied to evaluate within-patient clustering stability in patients with severe asthma. Cluster robustness was evaluated by using an independent cohort of patients with mild-to-moderate asthma. Data were available for 100 subjects with severe asthma (median age 55 years; 42% males). Two microbiome-driven clusters were identified; they were characterized by differences in asthma onset, smoking status, residential locations, percentage of blood and/or sputum neutrophils and macrophages, lung spirometry results, and concurrent asthma medications (all P values< .05). The cluster 2 patients displayed a commensal-deficient bacterial profile that was associated with worse asthma outcomes than those of the cluster 1 patients. Longitudinal clusters revealed high relative stability after 12 to 18 months in those with severe asthma. Further inclusion of an independent cohort of 24 patients with mild-to-moderate asthma was consistent with the clustering assignments. Unbiased microbiome-driven clustering revealed 2 distinct robust phenotypes of severe asthma that exhibited relative overtime stability. This suggests that the sputum microbiome may serve as a biomarker for better characterizing asthma phenotypes.

Long-term benefits in sleep, breathing and growth and changes in adherence and complications in children using noninvasive ventilation

RATIONALE: Long-term noninvasive ventilation (NIV) is a standard therapy for children with impaired sleep breathing and chronic respiratory insufficiency. Evidence of longitudinal benefits, however, is lacking. OBJECTIVES: The aim of this study is to determine the long-term NIV efficacy, its impact on growth and changes in adherence and complication rates over time. METHODS: This multicenter retrospective longitudinal cohort study examines children started on long-term NIV, both continuous and bi-level positive airway pressure, over a 10-year period. Data were collected at NIV initiation, initial follow-up and most recent visit including: 1) polysomnography parameters; 2) body mass index (BMI); 3) adherence; and 4) NIV-related complications. Mixed effects models were used for longitudinal analysis. MEASUREMENTS AND MAIN RESULTS: Sufficient data were available for 429 children. Sleep parameters, apnea-hypopnea index and gas exchange improved after NIV initiation with sustained benefits over time. Changes in BMI differed by BMI at NIV initiation; z-score in normal-weight children increased by 0.11 per year of therapy, 0.44 per year in underweight children with no change for overweight children and a drop of 0.15 per year in obese children. The number of complications remained low and unchanged (1.32, 95%CI 1.00–1.68) while adherence improved by 4% in percentage of days with use >4 hours per month and 19 extra minutes per night for each year of therapy. CONCLUSIONS: Long-term NIV is efficacious in correcting sleep and breathing parameters and demonstrated benefits in growth for underweight and obese children. Improvement in adherence and complication rates over time suggests the burden of NIV use decreases over time.

Functional Outcome Trajectories Following Inpatient Rehabilitation for TBI in the United States: A NIDILRR TBIMS and CDC Interagency Collaboration.

To describe trajectories of functioning up to 5 years after traumatic brain injury (TBI) that required inpatient rehabilitation in the United States using individual growth curve models conditioned on factors associated with variability in functioning and independence over time. Secondary analysis of population-weighted data from a multicenter longitudinal cohort study. Acute inpatient rehabilitation facilities. A total of 4624 individuals 16 years and older with a primary diagnosis of TBI. Ratings of global disability and supervision needs as reported by participants or proxy during follow-up telephone interviews at 1, 2, and 5 years postinjury. Many TBI survivors experience functional improvement through 1 and 2 years postinjury, followed by a decline in functioning and decreased independence by 5 years. However, there was considerable heterogeneity in outcomes across individuals. Factors such as older age, non-White race, lower preinjury productivity, public payer source, longer length of inpatient rehabilitation stay, and lower discharge functional status were found to negatively impact trajectories of change over time. These findings can inform the content, timing, and target recipients of interventions designed to maximize functional independence after TBI.

Unexpected Race and Ethnicity Differences in the US National Veterans Affairs Kidney Transplant Program.

Racial/ethnic minorities have lower rates of deceased kidney transplantation (DDKT) and living donor kidney transplantation (LDKT) in the United States. We examined whether social determinants of health (eg, demographics, cultural, psychosocial, knowledge factors) could account for differences in the Veterans Affairs (VA) Kidney Transplantation (KT) Program. We conducted a multicenter longitudinal cohort study of 611 Veterans undergoing evaluation for KT at all National VA KT Centers (2010-2012) using an interview after KT evaluation and tracking participants via medical records through 2017. Hispanics were more likely to get any KT (subdistribution hazard ratios [SHR] [95% confidence interval (CI)]: 1.8 [1.2-2.8]) or DDKT (SHR [95% CI]: 2.0 [1.3-3.2]) than non-Hispanic white in univariable analysis. Social determinants of health, including marital status (SHR [95% CI]: 0.6 [0.4-0.9]), religious objection to LDKT (SHR [95% CI]: 0.6 [0.4-1.0]), and donor preference (SHR [95% CI]: 2.5 [1.2-5.1]), accounted for some racial differences, and changes to Kidney Allocation System policy (SHR [95% CI]: 0.3 [0.2-0.5]) mitigated race differences in DDKT in multivariable analysis. For LDKT, non-Hispanic African American Veterans were less likely to receive an LDKT than non-Hispanic white (SHR [95% CI]: 0.2 [0.0-0.7]), but accounting for age (SHR [95% CI]: 1.0 [0.9-1.0]), insurance (SHR [95% CI]: 5.9 [1.1-33.7]), presenting with a living donor (SHR [95% CI]: 4.1 [1.4-12.3]), dialysis duration (SHR [95% CI]: 0.3 [0.2-0.6]), network of potential donors (SHR [95% CI]: 1.0 [1.0-1.1]), self-esteem (SHR [95% CI]: 0.4 [0.2-0.8]), transplant knowledge (SHR [95% CI]: 1.3 [1.0-1.7]), and changes to Kidney Allocation System policy (SHR [95% CI]: 10.3 [2.5-42.1]) in multivariable analysis eliminated those disparities. The VA KT Program does not exhibit the same pattern of disparities in KT receipt as non-VA centers. Transplant centers can use identified risk factors to target patients who may need more support to ensure they receive a transplant.

Determinants of Cross-Sectional and Longitudinal Health-Related Quality of Life in Memory Clinic Patients Without Dementia.

Objective:To identify determinants within 3 different domains (ie, somatic comorbidities, cognitive functioning, and neuropsychiatric symptoms [NPS]) of health-related quality of life (HRQoL) over time in memory clinic patients without dementia.Methods:This longitudinal multicenter cohort study with a 3-year observation period recruited 315 individuals (age: 69.8 ± 8.6, 64.4% males, Mini-Mental State Examination score 26.9 ± 2.6). A multivariable explanatory model was built using linear mixed effects models (forward selection per domain) to select determinants for self-perceived HRQoL over time, as measured by the EuroQoL-5D visual analogue scale (EQ VAS).Results:Mean HRQoL at study entry was 69.4 ± 15.6. The presence of agitation, appetite and eating abnormalities, and eyes/ears/nose (ie, sensory impairment) comorbidities were associated with a change in HRQoL over time. Agitation was most strongly associated with HRQoL over time.Conclusions:The association of somatic comorbidities and NPS in memory clinic patients with course of HRQoL shows that these should receive more awareness, detection, and monitoring by clinicians.

Factors associated with the remission of insomnia after traumatic brain injury: a traumatic brain injury model systems study

ABSTRACTObjective: To examine the factors associated with the remission of insomnia by examining a sample of individuals who had insomnia within the first two years after traumatic brain injury (TBI) and assessing their status at a secondary time point.Design and Methods: Secondary data analysis from a multicenter longitudinal cohort study. A sample of 40 individuals meeting inclusion criteria completed a number of self-report scales measuring sleep/wake characteristics (Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale, Insomnia Severity Index, Sleep Hygiene Index), fatigue and depression (Multidimensional Assessment of Fatigue, Patient Health Questionnaire-9), and community participation (Participation Assessment with Recombined Tools-Objective). One cohort was followed at 1 and 2 years post-injury (n = 19) while a second cohort was followed at 2 and 5 years post-injury (n = 21).Results: Remission of insomnia was noted in 60% of the sample. Those with persistent insomnia had significantly higher levels of fatigue and depression at their final follow-up and poorer sleep hygiene across both follow-up time-points. A trend toward reduced community participation among those with persistent insomnia was also found.Conclusion: Individuals with persistent post-TBI insomnia had poorer psychosocial outcomes. The chronicity of post-TBI insomnia may be associated with sleep-related behaviors that serve as perpetuating factors.

181 Geriatric Sepsis Remains a Rapidly Rising Source of Health Care Utilization and Admissions

Sepsis remains a major challenge in modern medicine. Despite significant attention and substantial research to improve patient care, outcomes are frequently poor, particularly in the geriatric population. Importantly, the incidence of sepsis continues to rise across the United States. Better characterization of increasingly susceptible groups is indicated to identify patients at risk of poor incomes, particularly in the emergency department (ED), where the majority of septic patients initially present. We sought to use California-wide population characteristics to describe changes in incidence and mortality specifically as they relate to age between 2008 and 2015 and better characterize high-risk populations. Multi-center retrospective longitudinal cohort study derived from data from the Office of Statewide Health Planning and Development (OSHPD) database in California. Institutional review board approval was obtained prior to investigation. The OSHPD database is a state-funded registry that receives data regarding ED visits, inpatient stays and discharge data. Inclusion criteria: adult patients (age ≥ 18 years), with a primary or secondary diagnosis of sepsis, severe sepsis or septic shock based on previously validated methodology. Incidence was calculated as the number of cases of sepsis per 1000 admissions whereas mortality was calculated as the proportion of admission. Age categories were defined as: 18 - 44, 45 - 64, 65 - 74, 75 - 84, and 85+. Microsoft Excel and SPSS, version 25, were used to analyze data. Descriptive statistics were used as indicated. A total of 1,566,283 patients with sepsis were identified between 2008 and 2015 from the OSHPD database. Patients older than 65 made up 60.3% of admissions for sepsis, despite representing approximately 12% of the population during this time period. Figure 1 shows a significant increase in the incidence of sepsis in all age groups with a decrease in mortality during this time period. The largest increase in incidence per 1000 admissions occurred in patients 75 - 84 years old and those 85+, from 83.3 to 111.8 and 100.2 to 133.3 over the 7-year time period, respectively. Other major associations with admission included multiple comorbidities, defined as a Charlson comorbidity score ≥ 3, particularly in the older age groups and nursing home status. Of patients 85+ years old, 18.5% were nursing home residents prior to admission whereas 37.3% were discharged to a nursing home. Geriatric sepsis remains a significant driver of health care utilization, resources and mortality despite increased sepsis awareness. Additional investigations into optimal care of the geriatric patient in the ED with sepsis are indicated.

227A novel risk prediction model for sudden cardiac death in childhood hypertrophic cardiomyopathy (HCM Risk-Kids)

Abstract Background Sudden cardiac death (SCD) is the most common mode of death in childhood hypertrophic cardiomyopathy (HCM) but there is no validated algorithm to identify those at highest risk. This study sought to develop and validate a SCD risk prediction model that provides individualized risk estimates. Methods A prognostic model was derived from an international, retrospective, multi-center longitudinal cohort study of 1024 consecutively evaluated patients aged ≤16 years. The model was developed using pre-selected predictor variables [unexplained syncope, maximal left ventricular (LV) wall thickness (MWT), left atrial diameter (LAD), LV outflow tract (LVOT) gradient and non-sustained ventricular tachycardia (NSVT)] identified from the literature and internally validated using bootstrapping. Results Over a median follow up of 5.3 years (IQR 2.6, 8.2, total patient years 5984), 89 (8.7%) patients died suddenly or had an equivalent event [annual event rate 1.49 (95% CI 1.15–1.92)]. The pediatric model was developed using pre-selected variables to predict the risk of SCD. The model's ability to predict risk at 5 years was validated; C-statistic was 0.69 (95% CI 0.66–0.72) and the calibration slope was 0.98 (95% CI 0.58–1.38). For every 10 ICDs implanted in patients with ≥6% 5-year SCD risk, potentially 1 patient will be saved from SCD at 5 years. Conclusions This new validated risk stratification model for SCD in childhood HCM provides accurate individualized estimates of risk at 5 years using readily obtained clinical risk factors. Acknowledgement/Funding British Heart Foundation

Distinct impact of antibiotics on the gut microbiome and resistome: a longitudinal multicenter cohort study

BackgroundThe selection pressure exercised by antibiotic drugs is an important consideration for the wise stewardship of antimicrobial treatment programs. Treatment decisions are currently based on crude assumptions, and there is an urgent need to develop a more quantitative knowledge base that can enable predictions of the impact of individual antibiotics on the human gut microbiome and resistome.ResultsUsing shotgun metagenomics, we quantified changes in the gut microbiome in two cohorts of hematological patients receiving prophylactic antibiotics; one cohort was treated with ciprofloxacin in a hospital in Tübingen and the other with cotrimoxazole in a hospital in Cologne. Analyzing this rich longitudinal dataset, we found that gut microbiome diversity was reduced in both treatment cohorts to a similar extent, while effects on the gut resistome differed. We observed a sharp increase in the relative abundance of sulfonamide antibiotic resistance genes (ARGs) by 148.1% per cumulative defined daily dose of cotrimoxazole in the Cologne cohort, but not in the Tübingen cohort treated with ciprofloxacin. Through multivariate modeling, we found that factors such as individual baseline microbiome, resistome, and plasmid diversity; liver/kidney function; and concurrent medication, especially virostatic agents, influence resistome alterations. Strikingly, we observed different effects on the plasmidome in the two treatment groups. There was a substantial increase in the abundance of ARG-carrying plasmids in the cohort treated with cotrimoxazole, but not in the cohort treated with ciprofloxacin, indicating that cotrimoxazole might contribute more efficiently to the spread of resistance.ConclusionsOur study represents a step forward in developing the capability to predict the effect of individual antimicrobials on the human microbiome and resistome. Our results indicate that to achieve this, integration of the individual baseline microbiome, resistome, and mobilome status as well as additional individual patient factors will be required. Such personalized predictions may in the future increase patient safety and reduce the spread of resistance.Trial registrationClinicalTrials.gov, NCT02058888. Registered February 10 2014

Trajectories of prescription drug misuse during the transition from late adolescence into adulthood in the USA: a national longitudinal multicohort study

Prescription drug misuse is most prevalent during young adulthood (ages 18-25 years). We aimed to identify prescription drug misuse trajectories for three drug classes (opioids, stimulants, and sedatives or tranquilisers) from adolescence into adulthood, assess the extent to which different trajectories are associated with symptoms of substance use disorder, and identity factors associated with high-risk prescription drug misuse trajectories. For this longitudinal multicohort study, nationally representative probability samples of 51 223 adolescents in the USA were followed up across eight waves from age 18 years (cohorts 1976-96) to age 35 years. Data were collected via self-administered paper questionnaires. Five prescription drug misuse trajectories were identified and the defining characteristic that differentiated the five trajectories was the age when past-year prescription drug misuse high frequency peaked: rare or no misuse at any age, peak at age 18 years, peak at ages 19-20 years, peak at age 23-24 years, and peak at ages 27-28 years. Similar prescription drug misuse trajectories were identified for each prescription drug class. The later peak misuse trajectory for sedatives and tranquilisers crested at an older age (35 years) than that for the other drug classes. Prescription drug misuse trajectories were all associated with significantly greater odds of having two or more substance use disorder symptoms at age 35 years, especially the later peak trajectories. In controlled analyses, risk factors associated with the high-risk latest peak prescription drug misuse trajectory included high school heavy drinking, cigarette smoking, marijuana use, poly-prescription drug misuse, white race, and not completing a 4-year university degree. Prescription drug misuse trajectories are heterogeneous, and any high-frequency prescription drug misuse is a strong risk factor for development of substance use disorders during adulthood, especially later-peak prescription drug misuse trajectories. These findings might help practitioners identify individuals at greatest risk for substance use disorders and target intervention strategies. National Institute on Drug Abuse, National Institutes of Health.

215. Outcomes of decompression without fusion in patients with lumbar spinal stenosis with back pain

BACKGROUND CONTEXT Some surgeons believe that the presence of substantial back pain in patients with lumbar spinal stenosis (LSS) is an indication for fusion; and that decompression alone may lead to worsening of the back pain from destabilization associated with facet resection. PURPOSE The purpose of this study is to determine if LSS patients with clinically significant back pain can obtain substantial improvements in back pain after a decompression alone without fusion. STUDY DESIGN/SETTING Multicenter longitudinal cohort study. PATIENT SAMPLE The DaneSpine database was used to identify 2737 patients with LSS without segmental instability and a baseline back pain VAS ≥ 50 who underwent a decompression procedure alone without fusion. OUTCOME MEASURES Back and leg pain VAS (0 to 100), Oswestry Disability Index (ODI) and EuroQOL-5D (EQ-5D) METHODS The DaneSpine database was used to identify 2737 patients with LSS without segmental instability and a baseline back pain VAS ≥ 50 who underwent a decompression procedure alone without fusion. Standard demographic and surgical variables and patient outcomes, including back and leg pain VAS (0 to 100), ODI and EQ-5D at baseline and 12 months postoperative were collected RESULTS A total of 1891 (69%) patients had 12 month follow-up data available for analysis; mean age of 66.4 years; 860 (46%) were male; mean BMI was 27.8kg/m2; 508 (27%) were current smokers. At 12 months postoperative, there were statistically significant improvements (p CONCLUSIONS Patients with LSS and clinically substantial back pain can obtain improvement in back pain after decompression only surgery and may not need a concomitant fusion. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

Advancing interdisciplinary research in head and neck cancer through a multicenter longitudinal prospective cohort study: the NETherlands QUality of life and BIomedical Cohort (NET-QUBIC) data warehouse and biobank

BackgroundWorldwide, over 500,000 people are diagnosed with head and neck cancer each year, a disease with major impact on life expectancy and quality of life. The purpose of the Netherlands Quality of life and Biomedical Cohort study (NET-QUBIC) is to advance interdisciplinary research that aims to optimize diagnosis, treatment, and supportive care for head and neck cancer patients and their informal caregivers.MethodsUsing an extensive assessment protocol (electronic clinical record form, patient reported outcome measures and fieldwork (interviews and physical tests)), clinical data and data on quality of life, demographic and personal factors, psychosocial (depression, anxiety, fatigue, pain, sleep, mental adjustment to cancer, posttraumatic stress), physical (speech, swallowing, oral function, malnutrition, physical fitness, neurocognitive function, sexual function), lifestyle (physical activity, nutrition, smoking, alcohol, drugs), and social factors (social function, social support, work, health care use, and costs) are collected and stored in the data warehouse. A longitudinal biobank is built with tumor tissue, blood and blood components, saliva samples, and oral rinses. An infrastructure for fieldwork and laboratory protocols is established at all participating centers. All patients fill out patient reported outcome measures before treatment and at 3, 6, 12, 24, 36, 48, and 60 months follow-up. The interviews, physical tests and biological sample collection are at baseline and 6, 12, and 24 months follow-up. The protocol for caregivers includes blood sampling and oral rinses at baseline and a tailored list of questionnaires, administered at the same time points as the patients. In total, 739 HNC patients and 262 informal caregivers have been included in 5 out of the 8 HNC centers in the Netherlands.DiscussionBy granting access to researchers to the NET-QUBIC data warehouse and biobank, we enable new research lines in clinical (e.g. treatment optimization in elderly patients), biological (e.g. liquid biopsy analysis for relapse detection), health related quality of life (e.g. the impact of toxicity on quality of life), and interrelated research (e.g. health related quality of life in relation to biomarkers and survival).

Differential Effects of Work-Related Task Training on Upper-Extremity Health in OT and Dental Hygiene Students

Abstract Date Presented 04/05/19 A longitudinal multicohort study was conducted to evaluate the impact of task training on upper-extremity musculoskeletal discomfort in health professional students. Differential effects on pain and grip strength were noted in dental hygiene students as compared to OT students. This study validates that repetitive task training has a negative impact on health and illuminates a need for development and implementation of preventive interventions for dental hygiene students. Primary Author and Speaker: Shawn Roll Contributing Authors: Naoko Kono, Jane Forrest, Wendy Mack

A Multicenter Observational Prospective Cohort Study of Association of the Prehospital National Early Warning Score 2 and Hospital Triage with Early Mortality

Aim of the Study To evaluate the ability of the prehospital National Early Warning Score 2 scale (NEWS2) to predict early mortality (within 48 hours) after the index event based on the triage priority assigned for any cause in the emergency department. Methods This is a multicenter longitudinal observational cohort study on patients attending Advanced Life Support units and transferred to the emergency department of their reference hospital. We collected demographic, physiological, and clinical variables, main diagnosis, and hospital triage level as well as mortality. The main outcome variable was mortality from any cause within two days of the index event. Results Between April 1 and November 30, 2018, a total of 1054 patients were included in our study. Early mortality within the first 48 hours after the index event affected 55 patients (5.2%), of which 23 cases (41.8%) had causes of cardiovascular origin. In the stratification by triage levels, the AUC of the NEWS2 obtained for short-term mortality varied between 0.77 (95% CI: 0.65-0.89) for level I and 0.94 (95% CI: 0.79-1) for level III. Conclusions The Prehospital Emergency Medical Services should evaluate the implementation of the NEWS2 as a routine evaluation, which, together with the structured hospital triage system, effectively serves to predict early mortality and detect high-risk patients.

Comparison of 24-hour and Office Pulse Wave Velocity for Prediction of Mortality in Hemodialysis Patients

Background: Mortality in hemodialysis patients still remains unacceptably high. Enhanced arterial stiffness is a known cardiovascular risk factor, and pulse wave velocity (PWV) has proven to be a valid parameter to quantify risk. Recent studies showed controversial results regarding the prognostic significance of PWV for mortality in hemodialysis patients, which may be due to methodological issues, such as assessment of PWV in the office setting (Office-PWV). Method: This study cohort contains patients from the “Risk stratification in end-stage renal disease – the ISAR study,” a multicenter prospective longitudinal observatory cohort study. We examined and compared the predictive value of ambulatory 24-hour PWV (24 h-PWV) and Office-PWV on mortality in a total of 344 hemodialysis patients. The endpoints of the study were all-cause and cardiovascular mortality. Survival analysis included Kaplan-Meier estimates and Cox regression analysis. Results: During a follow-up of 36 months, a total of 89 patients died, 35 patients due to cardiovascular cause. Kaplan-Meier estimates for tertiles of 24 h-PWV and Office-PWV were similarly associated with mortality. In univariate Cox regression analysis, 24 h-PWV and Office-PWV were equivalent predictors for all-cause and cardiovascular mortality. After adjustment for common risk factors, only 24 h-PWV remained solely predictive for all-cause mortality (hazard ratio 2.51 [95% CI 1.31–4.81]; p = 0.004). Conclusions: Comparing both measurements, 24 h-PWV is an independent predictor for all-cause-mortality in hemodialysis patients beyond Office-PWV.

Identification of Nonaggressive Pulmonary Nodules Using an Optimized Scoring System.

The purpose of this study was to define the optimal scoring method for identifying benign intrapulmonary lymph nodes. Subjects for this study were selected from the COPDGene study, a large multicenter longitudinal observational cohort study. A retrospective case-control analysis was performed using identified nodules on a subset of 377 patients who demonstrated 765 pulmonary nodules on their baseline computed tomography (CT) study. Nodule characteristics of 636 benign nodules (which resolved or showed <20% growth rate at 5 y follow-up) were compared with 51 nodules that occurred in the same lobe as a reported malignancy. Two radiologists scored each pulmonary nodule on the basis of intrapulmonary lymph node characteristics. A simple scoring strategy weighing all characteristics equally was compared with an optimized scoring strategy that weighed characteristics on the basis of their relative importance in identifying benign pulmonary nodules. A total of 479 of 636 benign pulmonary nodules had the majority of lymph node characteristics, whereas only 1 subpleural nodule with the majority of lymph node characteristics appeared to be malignant. Only 279 of 479 (58%) of benign pulmonary nodules with the majority of lymph node characteristics were intrafissural or subpleural. The optimized scoring strategy showed improved performance compared with the simple scoring strategy with average area under the curve of 0.80 versus 0.55. Optimized cutoff scores showed negative likelihood values for both readers of <0.2. A simulation showed a potential reduction in CT utilization of up to 36% for Fleischner criteria and up to 5% for LUNG-RADS. Nodules with the majority of lymph node characteristics, regardless of location, are likely benign, and weighing certain lymph node characteristics greater than others can improve overall performance. Given the potential to reduce CT utilization, lymph node characteristics should be considered when recommending appropriate follow-up.

Unraveling the Biopsychosocial Factors of Fatigue and Sleep Problems After Traumatic Brain Injury: Protocol for a Multicenter Longitudinal Cohort Study.

BackgroundFatigue and sleep problems are common after a traumatic brain injury (TBI) and are experienced as highly distressing symptoms, playing a significant role in the recovery trajectory, and they can drastically impact the quality of life and societal participation of the patient and their family and friends. However, the etiology and development of these symptoms are still uncertain.ObjectiveThe aim of this study is to examine the development of fatigue and sleep problems following moderate to severe TBI and to explore the changes in underlying biological (pain, brain damage), psychological (emotional state), and social (support family, participation) factors across time.MethodsThis study is a longitudinal multicenter observational cohort study with 4 measurement points (3, 6, 12, and 18 months postinjury) including subjective questionnaires and cognitive tasks, preceded by 7 nights of actigraphy combined with a sleep diary. Recruitment of 137 moderate to severe TBI patients presenting at emergency and neurology departments or rehabilitation centers across the Netherlands is anticipated. The evolution of fatigue and sleep problems following TBI and their association with possible underlying biological (pain, brain damage), psychological (emotional state), and social (support family, participation) factors will be examined. ResultsRecruitment of participants for this longitudinal cohort study started in October 2017, and the enrollment of participants is ongoing. The first results are expected at the end of 2020.ConclusionsTo the authors’ knowledge, this is the first study that examines the development of both post-TBI fatigue and sleep longitudinally within a biopsychosocial model in moderate to severe TBI using both subjective and objective measures. Identification of modifiable factors such as mood and psychosocial stressors may give direction to the development of interventions for fatigue and sleep problems post-TBI.Trial RegistrationNetherlands Trial Register NTR7162; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=7162 (Archived by WebCite at http://www.webcitation.org/6z3mvNLuy)International Registered Report Identifier (IRRID)RR1-10.2196/11295