Years Of Prospective Follow-up Research Articles

Mandibular Implant-Supported Overdentures Using Telescopic Crowns and Immediate Loading Protocol: A 2-Year Prospective Follow-up Study.

Implant-supported overdentures have been an effective treatment method for edentulous mandibles. However, the loading time after implant placement is still controversial. The purpose of this study was to evaluate the outcome of implant-supported overdentures using telescopic crowns for the treatment of edentulous patients with immediate loading protocol. This study was conducted on 22 edentulous mandibular patients visiting the Department of High Technique, National Hospital of Odonto - Stomatology, Ho Chi Minh City, Vietnam for prosthodontic rehabilitation. Each patient received four interforaminal implants. Immediate loading protocol was applied, and Ankylos Syncone copings systems was used to connect the prosthesis and the implants. The survival rate of implants and prostheses, as the primary outcome, were evaluated at 6 months, 01 year, and 02 years post-surgery. Peri-implant tissue condition, peri-implant bone loss, and patient satisfaction were the secondary outcomes. The implant survival rate was 98.9% with 01 failed implant. The peri-implant bone loss changes after 6 months, 01 year, and 02 years were 0.07 ± 0.22 mm, 0.12 ± 0.3 mm, and 0.15 ± 0.2 mm, respectively. No gingival hyperplasia was recorded. The prosthesis survival rate was 86.4% with 1 fractured overdenture, 1 overdenture relining and 1 abutment fracture. Mandibular rehabilitation using implant-supported overdenture with telescopic crowns and immediate loading protocol showed high survival rates of both implant and prosthesis in 2-year follow-up.

Prospective Trial of Sacroiliac Joint Fusion Using 3D-Printed Triangular Titanium Implants: 5-Year Follow-Up.

Prospective, multicenter, single arm study with 5-year follow up. To report long-term (5-year) safety, effectiveness, and radiographic outcomes after sacroiliac (SI) joint fusion (SIJF) with 3D-printed triangular titanium implants (TTI) and compare them with solid titanium plasma spray coated implants. A large literature base supports minimally invasive SIJF with TTI for chronic SIJ dysfunction. SIJF with TTI was performed in 51 subjects and scheduled follow-up occurred at 3, 6, 12, 24 and 60 months. Postoperative visits included quality of life questionnaires and functional tests. A high-resolution CT scan was performed at either 6 or 12 months, and again at 60 months. All CT scans were interpreted by an independent musculoskeletal radiologist. 5-year follow-up was available in 36 of 51 subjects (71%). At 5 years, improvements in SI joint pain (58.1 points [0-100 scale]), SIJ-related disability (Oswestry Disability Index [ODI], 25.4 points) and quality of life (EuroQOL 5D, 0.24 points, and EuroQOL visual analog scale, 13.4 points) were sustained and showed no signs of diminution. The percentage of patients using opioids for SIJ pain decreased markedly from baseline (57%) to 5 years (17%). Physical function tests showed persistent improvements from baseline. There was no evidence of device breakage, migration or subsidence and few late adverse events occurred attributable to the device. Independent analysis of CT scans showed bone opposed to implants in all cases, and evidence of bone bridging in 90% of cases, and no evidence of radiolucency or other adverse bone reactions. Prospective 5-year follow-up showed that SIJ fusion using 3D-printed TTI resulted in immediate, marked, and persistent improvements in pain and quality of life, with improved physical function, reduced opioid use, and a low rate of revision surgery. Radiographic evidence showed implant integration and joint fusion. Level II.

Combining cohorts of prospectively collected and linked data to improve health after release from prison

BackgroundWhile people who experience incarceration have remarkably poor health profiles, undertaking research to inform evidence-based responses is complicated by difficulties of recruiting people in prison; high rates of socioeconomic marginalisation, study attrition; and legislative and financial barriers to linked data research. There are many advantages to pooling data from multiple studies involving people who experience incarceration, including greater statistical power and geographic and participant heterogeneity. However, there are also challenges that need to be addressed. MethodsWe combined four prospective cohort studies of adults released from prisons in four Australian states. Pre-release interviews, and validated screening assessments, were linked to primary care, medicine dispensing, hospital, alcohol and other drug treatment services, ambulatory mental health, ambulance, corrective services, and death records. Data were harmonised by team members reviewing variable definitions and categories within subject domains. ResultsThe combined cohort consists of 4,232 adults, including 1,544 Indigenous people and 905 women, with a median age of 31 years. Data linkage will enable a median of 9.3 years of prospective follow-up after release from incarceration. Differences in data structures, coding systems between and within datasets, changes over time, and grouping of records belonging to the same event were also addressed. ConclusionThis combined multi-site cohort study is an example of a complex, policy-oriented data linkage project. It was developed to underpin evidence-based, culturally appropriate interventions, health policy and service development for people who were incarcerated. This presentation will discuss the processes and pitfalls experienced while building a multi-sectoral, multi-jurisdictional data linkage project.

Course and Prediction of Dissociation in Patients with Borderline Personality Disorder and Personality-Disordered Comparison Subjects: A 24-Year Follow-Up Study

ABSTRACT The first purpose of this study was to determine the course of dissociation among patients with borderline personality disorder (BPD) and personality-disordered comparison subjects (OPD) over 24 years of prospective follow-up. The second purpose was to determine clinically meaningful predictors of dissociation among patients with BPD. The Dissociative Experiences Scale (DES) was administered to 290 patients with BPD and 72 personality-disordered comparison subjects at baseline, and then once every two years over 24 years of prospective follow-up. Baseline predictors were assessed with the Revised Childhood Experiences Questionnaire (CEQ-R), the SCID-I, and the Shipley Institute of Living Scale. Time-varying predictors were assessed at baseline and every subsequent two years by means of the Abuse History Interview (AHI). Patients with BPD had higher baseline dissociation scores than personality-disordered comparison subjects. Whilst dissociation decreased significantly over time for both patient groups, the BPD group showed a steeper decline. Severity of childhood sexual abuse, adult history of rape, adult history of partner violence, and IQ were multivariate predictors of dissociation among patients with BPD. Taken together, the present findings suggest that a combination of interpersonal trauma exposure and cognitive abilities may contribute to the severity of dissociation in adult patients with BPD.

A Prospective 1-Year Follow-up of Glycemic Status and C-Peptide Levels of COVID-19 Survivors with Dysglycemia in Acute COVID-19 Infection.

We evaluated changes in glycemic status, over 1 year, of coronavirus disease 2019 (COVID-19) survivors with dysglycemia in acute COVID-19. COVID-19 survivors who had dysglycemia (defined by glycosylated hemoglobin [HbA1c] 5.7% to 6.4% or random glucose ≥10.0 mmol/L) in acute COVID-19 were recruited from a major COVID-19 treatment center from September to October 2020. Matched non-COVID controls were recruited from community. The 75-g oral glucose tolerance test (OGTT) were performed at baseline (6 weeks after acute COVID-19) and 1 year after acute COVID-19, with HbA1c, insulin and C-peptide measurements. Progression in glycemic status was defined by progression from normoglycemia to prediabetes/diabetes, or prediabetes to diabetes. Fifty-two COVID-19 survivors were recruited. Compared with non-COVID controls, they had higher C-peptide (P< 0.001) and trend towards higher homeostasis model assessment of insulin resistance (P=0.065). Forty-three COVID-19 survivors attended 1-year reassessment. HbA1c increased from 5.5%±0.3% to 5.7%±0.2% (P<0.001), with increases in glucose on OGTT at fasting (P=0.089), 30-minute (P=0.126), 1-hour (P=0.014), and 2-hour (P=0.165). At baseline, 19 subjects had normoglycemia, 23 had prediabetes, and one had diabetes. Over 1 year, 10 subjects (23.8%; of 42 non-diabetes subjects at baseline) had progression in glycemic status. C-peptide levels remained unchanged (P=0.835). Matsuda index decreased (P=0.007) and there was a trend of body mass index increase from 24.4±2.7 kg/m2 to 25.6±5.2 (P=0.083). Subjects with progression in glycemic status had more severe COVID-19 illness than non-progressors (P=0.030). Reassessment was not performed in the control group. Subjects who had dysglycemia in acute COVID-19 were characterized by insulin resistance. Over 1 year, a quarter had progression in glycemic status, especially those with more severe COVID-19. Importantly, there was no significant deterioration in insulin secretory capacity.

Detection of subclinical enthesitis by ultrasonography in patients with psoriasis and controls.

Psoriasis is a widespread chronic inflammatory skin disease; enthesitis is inflammation of the tendon, ligament, and joint capsule insertion, prevalent in patients with psoriatic arthritis. The aim of study to evaluate the utility of the Madrid Sonography Enthesitis Index scoring system for accurate detection of subclinical enthesitis in patients with Psoriasis compared with healthy controls. Another objective was to assess increase in enthesis area and Psoriatic arthritis incidence, in a prospective 1-year follow-up. Patients aged ≥18 years who were diagnosed with Psoriasis, without musculoskeletal complaints, and who did not have any clinical sign and/or symptom of enthesitis and synovitis were included in the study. The patients and healthy controls were evaluated with ultrasonography. Ultrasonography evaluation consisted of the detection of gray-scale enthesitis and power Doppler signal in the enthesis areas. The Madrid Sonography Enthesitis Index scoring system was used to quantify the extent of the sonographic enthesis abnormalities. The mean MASEI score, structure, thickness, erosion, and calcification were significantly higher in the Psoriasis group than in the control group. The mean MASEI score, structure, erosion, and calcification measurements were significantly higher at the last examination when compared to the first examination. The triceps was the most commonly affected tendon in both groups. Ultrasonography is an important tool for diagnosis and follow-up of subclinical enthesitis in patients with psoriasis. Regardless of disease duration and severity, patients should be screened using ultrasonography at yearly intervals.

Prospective 5-Year Follow-up Study of Spleen Stiffness Measurement with a Spleen-Dedicated Module (SSM@100Hz) for Predicting Hepatic Decompensation in cACLD: Competitive Risk Analysis

Prospective 5-Year Follow-up Study of Spleen Stiffness Measurement with a Spleen-Dedicated Module (SSM@100Hz) for Predicting Hepatic Decompensation in cACLD: Competitive Risk Analysis

Competitive Risk Analysis of Spleen Stiffness Measurement with a Spleen-Dedicated Module (SSM@100Hz) for Predicting de-novo HCC Occurrence in cACLD Patients: A Prospective 5-Year Follow-up Study

Competitive Risk Analysis of Spleen Stiffness Measurement with a Spleen-Dedicated Module (SSM@100Hz) for Predicting de-novo HCC Occurrence in cACLD Patients: A Prospective 5-Year Follow-up Study

Prospective 5-year follow-up of L5-S1 versus L4-5 midline decompression and interspinous-interlaminar fixation as a stand-alone treatment for spinal stenosis compared with laminectomies.

Spinal stenosis treatment includes laminectomies with or without fusion or with interspinous distraction with or without fixation. Lack of published data on interspinous fixation devices (IFD) at L5-S1 is less considered as an option due to the smaller anatomical S1 spinous process and the higher stresses from the immobile sacrum. Our objective was to evaluate the outcomes of an IFD used as a stand-alone treatment for spinal stenosis at L5-S1 and L4-5 compared to historical data on open laminectomies. Prospective comparative cohort study (Level 2) looking at collected preoperatively and postoperatively Visual Analog Scores (VAS) and Oswestry Disability Index (ODI) data, complications, and revision rates on 100 consecutive patients with spinal stenosis treated with midline decompression and InSpan (InSpan LLC, Malden, MA, USA) IFD, at L5-S1 and L4-5, up to five-year follow-up. All patients were treated by a single surgeon in an academic private practice. Historical published outcome data for open laminectomies were compared. Among the 100 patients, 45 underwent surgery at L5-S1 with a mean VAS pain score that decreased by 75% and ODI improved by 63% (P<0.001). Fifty-five patients had surgery at L4-5 with mean VAS and ODI scores improved by 80% and 66% (P<0.001) respectively. Preoperative and postoperative ODI and preoperative VAS scores were similar at L5-S1 and L4-5, however, postoperative VAS scores were significantly less for L4-5 versus L5-S1 (P<0.01). All surgeries were completed in less than one hour. There was a total of one L4-5 revision (1.8%) and two L5-S1 revisions (4.4%). Comparable laminectomy data showed decrease in VAS and ODI scores by 51% and 62% (P<0.05). The reoperation rate for laminectomies at five to ten years varied up to 24%. Spinal stenosis patients treated with midline decompression and InSpan IFD, used as a stand-alone treatment for interspinous-interlaminar fixation, at L4-5 and L5-S1, showed improved outcome scores and low complication and revision rates at five years and were comparable to historical open laminectomy data. InSpan is a successful substitute for laminectomies in selected patients and was performed in less than 60 minutes. We recommend choosing the appropriately sized implant to achieve adequate distraction decompression to avoid recurrent symptoms.

A Prospective, Observational, Multi-Center Study of Rurioctocog Alfa Pegol Pharmacokinetic-Guided Prophylaxis Using Mypkfit in Severe Hemophilia a Patients in Taiwan (ATTRACT-HA Study): An Interim Analysis

Background Rurioctocog alfa pegol is a polyethylene glycol (PEG)-ylated recombinant antihemophilic factor VIII (FVIII) with an extended half-life, which allows prolonged dosing intervals. Using myPKFiT, the first and only FDA-cleared PK dosing software, healthcare professionals can simulate dosing regimens using patients' pharmacokinetic profiles. According to 2020 WFH Guidelines for the Management of Hemophilia, the trough level is suggested to be increased from &amp;gt;1% to 3-5% or higher to improve patient care (Srivastava et al. Haemophilia 2020). The Phase 3b Continuationstudy demonstrated that maintaining trough levels ≥3% with PK-guided prophylaxis in patients with severe haemophilia A reduced spontaneous annual bleeding rate (sABR), and thus led to the resolution of target joints (Chowdary et al. Haemophilia 2020). The ATTRACT-HA study will provide the first multi-center real-world evidence in Taiwan whether maintaining a predicted trough level of ≥3% using rurioctocog alfa pegol PK-guided prophylaxis using myPKFiT in severe hemophilia A patients can result in improved clinical outcomes as well as a better quality of life.This interim analysis will focus on the hemophilia-related characterization of the enrolled patients. Methods We enrolled patients, ≥12 years old with body weights of ≥30 kg and ≤140 kg, diagnosed with severe hemophilia A (FVIII clotting activity &amp;lt;1%). The enrolled patients were required to be on prophylaxis with rurioctocog alfa pegol for more than a month before the baseline visit and their historical bleeding data, 6 months prior to the screening visit, was also collected. Patients with a stable dosing regimen at the baseline underwent a myPKFiT PK assessment to determine if a patient was in the trough level &amp;lt;3% or ≥3% group (Figure 1). The primary endpoint of this study was to evaluate the clinical outcomes based on ABR and AJBR. Secondary endpoints included the scores of clinical outcomes with haemophilia early arthropathy detection with ultrasound (HEAD-US), the Haemophilia Quality of Life Questionnaire, and the international physical activity questionnaire (IPAQ) assessing patients' daily activity level performed at the baseline visit and in month 12. The date of data cut-off for this interim analysis was 5 th of January 2023. Results A total of 16 patients with severe hemophilia A were enrolled and stratified by myPKFiT PK assessment into two groups, with a trough level either &amp;lt;3% or ≥3%. There were 7 patients (median age: 23.0 y/o; Q1-Q3 15-29) in the trough level &amp;lt;3% group and 9 patients (median age: 43.0 y/o; Q1-Q3 35-55) in the trough level ≥3% group. Within 6 months prior to enrollment, 71.43% of the patients in the trough level &amp;lt;3% group experienced episodic bleeding, while only 44.44% of the patients experienced episodic bleeding in the trough level ≥3% group (Table 1). The median baseline HEAD-US score was numerically lower in the trough level &amp;lt;3% compared to the trough level ≥3% group (4.29 vs 24.11). The median score of Haem-A-QoL was 25.93 (Q1-Q3; 16.67-47.28) in the trough level &amp;lt;3% group and 42.93 (Q1-Q3; 28.89-48.37) in the trough level ≥3% group. Prospective 1-year follow-up assessments will be performed thereafter. Conclusion The ATTRACT-HA study is the first prospective, multi-center, observational study currently ongoing in Taiwan to provide real-world evidence of the effectiveness of rurioctocog alfa pegol PK-guided prophylaxis using myPKFiT app in patients with severe hemophilia A. In this interim report, we described the clinical features and factors of the study participants at the beginning of this real-world study. Between the two trough levels, we observed a higher percentage of patients experiencing episodic bleeding prior to PK-guided prophylaxis and lower baseline HEAD-US scores in the &amp;lt;3% trough level group, which may be in part due to the younger median age in this group. Acknowledgments The authors thank Dr. Brenden Chen for his contribution of clinical insight and editorial support during the abstract development. This study was funded by Takeda Pharmaceuticals Taiwan, Ltd. Disclosures Yi-Rou Lei, Chieh-Min Chen, Melody Cheng, Brenden Chen are employees of Takeda Pharmaceuticals Taiwan, Ltd. All the other authors disclose no relevant conflicts of interest.

Large spontaneous HBV DNA fluctuations and potential usefulness of a single-point measurement of combined HBV DNA and quantitative HBsAg for the exclusion of HBeAg-negative chronic hepatitis B: A prospective Tunisian cohort study

Background and study aimDuring the natural course of HBeAg-negative chronic hepatitis B (CHB), fluctuations in hepatitis B virus (HBV) DNA and alanine aminotransferase (ALT) levels are often observed, making the classification of patients difficult. We aimed to describe spontaneous short-term HBV DNA level fluctuations and to assess the usefulness of qHBsAg in Tunisian patients with HBeAg-negative chronic HBV infection. Patients and methodsWe included 174 treatment-naive Tunisian patients with HBeAg-negative chronic HBeAg-negative HBV infection. A prospective 1-year follow-up was conducted with serial determinations of HBV DNA, ALT levels, and qHBsAg. The patients were classified into three groups: inactive carriers (G1), patients with negative HBeAg CHB (G2), and patients with an “indeterminate state” (G3). For the latter group, a liver biopsy was indicated. ResultsOnly genotype D was detected. During follow-up, 21.6% and 19.5% of patients with a low initial (<2,000 IU/ml) and intermediate viral load (2,000–20,000 IU/ml) experienced a subsequent increase in their HBV DNA levels above 2,000 and 20,000 IU/ml, respectively. Significant variations in viral load were observed in 61.1% of patients at 6-month intervals. Among the 174 patients, 89 (51.1%) belonged to G1, 33 (19%) to G2, and 52 (29.9%) to G3. Fourteen patients have undergone a liver biopsy, of whom seven showed moderate to severe liver disease. Combination of HBV DNA < 2,000 IU/ml and qHBsAg < 832 IU/ml excluded CHB in 98.4% of cases. A cutoff point for qHBsAg < 100 IU/ml associated with an annual decline of > 0.5 log 10 IU/ml is a good predictor marker of functional cure for hepatitis B. ConclusionsThis study highlights the large short-term fluctuations in HBV DNA in patients with HBeAg-negative chronic HBeAg-negative HBV infection with genotype D. Thus, using the cutoff value of 832 for qHBsAg combined with that of 2,000 for HBV DNA makes it possible to exclude CHB for most patients.

Course and predictors of social security disability insurance in patients with borderline personality disorder over 24 years of prospective follow-up

BackgroundThe utilization of Social Security Disability Insurance (SSDI) is frequent in patients with borderline personality disorder (BPD) and may represent a meaningful marker of a patient’s symptom severity, poor psychosocial functioning, and/or inner suffering. Over 24 years of prospective follow-up, the present study aims to describe the course of SSDI and assess the role of clinically relevant predictors.MethodsA total of 290 inpatients with BPD were interviewed at baseline and 12 consecutive follow-up waves, each separated by two years, after index hospitalization. Included were also 72 inpatients with other personality disorders. Surviving patients were reinterviewed. A series of interviews and self-report measures were used to assess psychosocial functioning and treatment history, axis I and II disorders, and childhood/adult adversity.ResultsResults show that rates of SSDI utilization were relatively stable over 24 years of follow-up (on average, 47.2% of the patients with BPD were on SSDI). Patients with BPD were three times more likely to be on SSDI than patients with other PDs. Patients with BPD displayed flexibility in their usage of SSDI. By 24 years, 46% of patients remitted, out of which 85% experienced recurrence and 50% of the patients had a new onset over time. In multivariate analyses, four variables were found to predict SSDI status in patients with BPD over time. These variables were: age 26 or older, lower IQ, severity of non-sexual childhood abuse, and presence of PTSD.ConclusionsThe results of this study suggest that a combination of a demographic factors, childhood adversity, natural endowment, and comorbidity are significant predictors of receiving SSDI over time. On a group level, there is a relative stability of SSDI usage over time, but on the individual level, the present study found a high fluctuation in receiving SSDI over 24 months of prospective follow-up.

Pathways to Health Reported by Patients With Borderline Personality Disorder With a Good Overall Outcome Versus a Fair-Poor Outcome Over 24 Years of Prospective Follow-Up.

Our objective was to determine pathways to health reported by patients with borderline personality disorder (BPD) who had and had not attained a good overall outcome over 24 years of prospective follow-up. Overall outcome symptomatically and psychosocially and 11 pathways to health related to vocation, relationships, activities, and psychiatric treatment that patients reported were helpful to their functioning or feeling better about themselves were assessed at 12 contiguous 2-year follow-up periods using a semistructured interview. Good outcome patients reported significantly higher rates of pathways related to work performance, relationships with friends, relationship with a partner/spouse, and athletic activities. In contrast, patients with a fair-poor outcome reported significantly higher rates of psychotherapy and psychotropic medication as pathways. Taken together, the results of this study suggest that a good overall outcome is significantly associated with reported vocational, interpersonal, and activity pathways, while a fair-poor outcome is significantly associated with reported treatment-related pathways.

Combinations of Sarcopenia Diagnostic Criteria by Asian Working Group of Sarcopenia (AWGS) 2019 Guideline and Incident Adverse Health Outcomes in Community-Dwelling Older Adults.

This study aimed to investigate the association between combinations of sarcopenia criteria by the Asian Working Group of Sarcopenia (AWGS) 2019 guideline and incident adverse health outcomes. Longitudinal analyses of a cohort study. We conducted prospective 2-year follow-up analyses (N= 1959) among community-dwelling older adults enrolled in the nationwide Korean Frailty and Aging Cohort Study (KFACS). From the KFACS, 1959 older adults (52.8% women; mean age= 75.9 ± 3.9years) who underwent assessments for appendicular skeletal mass using dual-energy X-ray absorptiometry, handgrip strength, usual gait speed, 5-times sit-to-stand test, and Short Physical Performance Battery (SPPB) at baseline were included. Participants with each adverse health outcome [mobility disability, falls, and instrumental activities of daily living (IADL) disabilities] at baseline were excluded for each corresponding analysis. Multivariable logistic regression was performed to examine whether sarcopenia defined by different diagnostic criteria was associated with incident adverse health outcomes after 2 years. A total of 444 participants (22.7%) were diagnosed with sarcopenia as defined by AWGS 2019. In the multivariable analysis, sarcopenia defined as both low muscle mass and low physical performance increased the risk of mobility disability (OR 2.14, 95% CI 1.35-3.38) and falls (1.74, 95% CI 1.21-2.49). Only the criterion defined as both low muscle mass and physical performance using the SPPB increased the risk of falls with fracture (2.53, 95% CI 1.01-6.35) and IADL disabilities (2.77, 95% CI 1.21-6.33). However, sarcopenia defined as both low muscle mass and low hand grip strength showed no associations with the incidence of any of the adverse health outcomes. Our study suggests that the predictive value of adverse health outcomes for community-dwelling older adults is better when diagnosed with sarcopenia based on low muscle mass and physical performance. Furthermore, using the SPPB as a diagnostic tool for low physical performance may improve the predictive validity for falls with fracture and IADL disability. Our findings may be helpful for the early detection of individuals with sarcopenia who have a higher risk of adverse health outcomes.

Lessons learned in implementing the Low Birthweight Infant Feeding Exploration study: A large, multi-site observational study.

Globally, early and optimal feeding practices and strategies for small and vulnerable infants are limited. We aim to share the challenges faced and implementation lessons learned from a complex, mixed methods research study on infant feeding. A formative, multi-site, observational cohort study using convergent parallel, mixed-methods design. Twelve tertiary/secondary, public/private hospitals in India, Malawi and Tanzania. Moderately low birthweight infants (MLBW; 1.50-2.49 kg). We assessed infant feeding and care practices through: (1) assessment of in-facility documentation of 603 MLBW patient charts; (2) intensive observation of 148 MLBW infants during facility admission; and (3) prospective 1-year follow-up of 1114 MLBW infants. Focus group discussions and in-depth interviews gathered perspectives on infant feeding among clinicians, families, and key stakeholders. The outcomes of the primary study were: (1) To understand the current practices and standard of care for feeding LBW infants; (2) To define and document the key outcomes (including growth, morbidity, and lack of success on mother's own milk) for LBW infants under current practices; (3) To assess the acceptability and feasibility of a system-level Infant and Young Child Feeding (IYCF) intervention and the proposed infant feeding options for LBW infants. Hospital-level guidelines and provision of care for MLBW infants varied across and within countries. In all, 89% of charts had missing data on time to first feed and 56% lacked discharge weights. Among 148 infants observed in-facility, 18.5% were discharged prior to meeting stated weight goals. Despite challenges during COVID, 90% of the prospective cohort was followed until 12 months of age. Enrolment and follow-up of this vulnerable population required additional effort from researchers and the community. Using a mixed-methods exploratory study allowed for a comprehensive understanding of MLBW health and evidence-based planning of targeted large-scale interventions. Multi-site partnerships in global health research, which require active and equal engagement, are instrumental in avoiding duplication and building a stronger, generalisable evidence base.

#5650 METABOLIC BLOOD BIOMARKER PROFILING FOR CHRONIC KIDNEY DISEASE PREDICTION – EVIDENCE FROM 275,000 INDIVIDUALS IN THE UK BIOBANK

Abstract Background and Aims Early identification of individuals at high risk of developing chronic kidney disease and other chronic conditions is essential for targeted prevention. Here, we assess the utility of metabolic blood biomarkers in predicting the onset of chronic kidney disease in over 250,000 individuals from UK Biobank, beyond established risk factors and polygenic risk scores. Method Circulating blood biomarkers, including lipids, fatty acids, amino acids, glycolysis metabolites and inflammation markers were measured by a low-cost nuclear magnetic resonance (NMR) metabolomics assay in around 275,000 plasma samples from the UK Biobank. During a prospective 10-year follow-up, over 6000 incident chronic kidney disease events were obtained from national health registries. Using multivariable regression modelling, we derived a 10-year risk score for chronic kidney disease onset. We assessed the predictive performance of the biomarker risk score in comparison to standard risk factors (age, sex, prevalent diabetes, body mass index, systolic and diastolic blood pressure, smoking status and use of cholesterol lowering medication), clinical chemistry measurements (HbA1c, LDL and HDL cholesterol, total cholesterol and eGFR) and polygenic risk scores. We evaluated the performance of the risk score in two practical scenarios: in a general population screening setting and in a clinical use case of stratifying kidney disease risk among prevalent type 2 diabetics. We further illustrate applications of the biomarker risk scores in predicting the risk of other chronic diseases, such as cardiovascular outcomes, in general population settings. Results In the general population screening setting, adding the metabolic biomarkers to a simple model of standard risk factors substantially improved the predictive performance, with area under the receiver operating characteristic curve (AUC) increasing from 0.74 to 0.82. When compared to more comprehensive model including also clinical chemistry measurements and polygenic risk scores, the improvements were also significant, albeit more modest, with the AUC increasing from 0.81 to 0.83. Even more substantial gains were observed in a clinical use case scenario of stratifying risk of chronic kidney disease onset among prevalent type 2 diabetics. Among diabetics with mildly to moderately decreased kidney function at the time of blood sampling (eGFR 60-90), adding the metabolic biomarkers in a comprehensive model including standard risk factors, clinical chemistry measurements and polygenic risk scores increased the AUC from 0.60 to 0.70. Conclusion Circulating metabolic biomarkers enhanced the prediction of chronic kidney disease onset beyond standard risk factors and polygenic risk scores. From a translational perspective, this may complement the identification of high-risk individuals in both general population and clinical settings beyond current risk factor assessment, while simultaneously informing on the risk of other chronic diseases.

Joint distraction using a purpose-built device for knee osteoarthritis: a prospective 2-year follow-up

ObjectiveKnee distraction treatment for end-stage osteoarthritis successfully postpones arthroplasty for years. Studies performed thus far used general intended use, patient-personalised or custom-made devices. In this study, for the first time,...

Sex-based differences in risk factors for incident myocardial infarction and stroke in the UK Biobank.

This study examined sex-based differences in associations of vascular risk factors with incident cardiovascular events in the UK Biobank. Baseline participant demographic, clinical, laboratory, anthropometric, and imaging characteristics were collected. Multivariable Cox regression was used to estimate independent associations of vascular risk factors with incident myocardial infarction (MI) and ischaemic stroke for men and women. Women-to-men ratios of hazard ratios (RHRs), and related 95% confidence intervals, represent the relative effect-size magnitude by sex. Among the 363313 participants (53.5% women), 8470 experienced MI (29.9% women) and 7705 experienced stroke (40.1% women) over 12.66 [11.93, 13.38] years of prospective follow-up. Men had greater risk factor burden and higher arterial stiffness index at baseline. Women had greater age-related decline in aortic distensibility. Older age [RHR: 1.02 (1.01-1.03)], greater deprivation [RHR: 1.02 (1.00-1.03)], hypertension [RHR: 1.14 (1.02-1.27)], and current smoking [RHR: 1.45 (1.27-1.66)] were associated with a greater excess risk of MI in women than men. Low-density lipoprotein cholesterol was associated with excess MI risk in men [RHR: 0.90 (0.84-0.95)] and apolipoprotein A (ApoA) was less protective for MI in women [RHR: 1.65 (1.01-2.71)]. Older age was associated with excess risk of stroke [RHR: 1.01 (1.00-1.02)] and ApoA was less protective for stroke in women [RHR: 2.55 (1.58-4.14)]. Older age, hypertension, and smoking appeared stronger drivers of cardiovascular disease in women, whereas lipid metrics appeared stronger risk determinants for men. These findings highlight the importance of sex-specific preventive strategies and suggest priority targets for intervention in men and women.

Incident cardiovascular events and imaging phenotypes in UK Biobank participants with past cancer

ObjectivesTo evaluate incident cardiovascular outcomes and imaging phenotypes in UK Biobank participants with previous cancer.MethodsCancer and cardiovascular disease (CVD) diagnoses were ascertained using health record linkage. Participants with cancer history...

Subtalar Arthroereisis as a Surgical Option in the Reconstruction of Progressive Collapsing Foot Deformity: A Prospective 3-year Follow-up Study on Patient Satisfaction and Causes for Implant Removal in 40 Cases Treated with the HyProCure Implant

Subtalar Arthroereisis as a Surgical Option in the Reconstruction of Progressive Collapsing Foot Deformity: A Prospective 3-year Follow-up Study on Patient Satisfaction and Causes for Implant Removal in 40 Cases Treated with the HyProCure Implant