Prospective 5-year Follow-up Study Research Articles

A prospective 10-year follow-up study after sublobar resection for ground-glass opacity-dominant lung cancer

This single-arm multi-institutional prospective study aimed to evaluate the 10-year outcomes of sublobar resection for small-sized ground-glass opacity-dominant lung cancer. Among 73 patients prospectively enrolled from 13 institutions between November 2006 and April 2012, 53 ground-glass opacity-dominant lung cancer patients underwent sublobar resection with wedge resection as the first choice. The inclusion criteria were maximum tumor size of 8–20 mm; ≥ 80% ground-glass opacity ratio on high-resolution computed tomography; lower 18F-fluorodeoxyglucose accumulation than the mediastinum; intraoperative pathological diagnosis of adenocarcinoma in situ; and no cancer cells on intraoperative cut margins. The primary endpoint was a 10-year disease-specific survival. The 53 eligible patients had a mean tumor size of 14 ± 3.4 mm and a mean ground-glass opacity ratio of 95.9 ± 7.2%. Wedge resection and segmentectomy were performed in 39 and 14 patients, respectively. The final pathological diagnoses were adenocarcinoma in situ in 47 patients (88.7%) and adenocarcinoma with mixed subtype in 6 patients (11.3%). The 10-year disease-specific survival and overall survival were 100% and 96.2%, respectively, during a median follow-up period of 120 months (range, 37–162 months). Ground-glass opacity-dominant small lung cancer is cured by sublobar resection when patients are strictly selected by the inclusion criteria of this study.

A holistic analysis of symptom profiles among people with long COVID-19 in India: A prospective 1-year follow-up study

ObjectivesExamining the health of COVID-19 patients after hospitalization, with a focus on monitoring common and incapacitating symptoms at four weeks and a year after discharge, is a seldom investigated topic that may yield important information about long-term consequences. MethodsPatients who had been admitted for treatment after exhibiting COVID-19 symptoms underwent multiple choice semi-structured interviews in April 2021, followed by a follow-up interview in May 2022. We intended to look into the levels of recovery, the effect on functional abilities, quality of life, fatigue scores, mental health, activity of daily living, and an overall spectrum of symptoms. ResultsOut of 350 participants, 148 respondents (42.3 %) recovered after 1 year of illness and 202 (57.7 %) were still experiencing symptoms at the time of survey completion. In our survey, fatigue (97.1 %), dyspnoea (86.6 %), dry cough (83.4 %), joint pain (83.4 %), tingling in limbs (74.6 %), myalgia (59.1 %) and were visible even after 1 year but with reduced severity. Statistically significant change was noticed in fatigue scores, quality of life, mental health and activity of daily living among long COVID survivors at baseline and after 1 year. ConclusionsThe frequency of symptoms in our study fits within this fairly broad range noted in literature. Nonetheless, our data do not appear to support the hypothesis that symptoms that linger following COVID-19 are self-limiting: the prevalence of persisting symptoms in our study did not decrease with time.

SAT-078-YI Prospective 5-year follow-up study of spleen stiffness measurement with a spleen-dedicated module (SSM@100 Hz) for predicting hepatic decompensation in cACLD: competitive risk analysis

SAT-078-YI Prospective 5-year follow-up study of spleen stiffness measurement with a spleen-dedicated module (SSM@100 Hz) for predicting hepatic decompensation in cACLD: competitive risk analysis

Association of NOTCH3 Variant Risk Category With 2-Year Clinical and Radiologic Small Vessel Disease Progression in Patients With CADASIL.

Pathogenic variants in NOTCH3 are the main cause of hereditary cerebral small vessel disease (SVD). SVD-associated NOTCH3 variants have recently been categorized into high risk (HR), moderate risk (MR), or low risk (LR) for developing early-onset severe SVD. The most severe NOTCH3-associated SVD phenotype is also known as cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL). We aimed to investigate whether NOTCH3 variant risk category is associated with 2-year progression rate of SVD clinical and neuroimaging outcomes in CADASIL. A single-center prospective 2-year follow-up study was performed of patients with CADASIL. Clinical outcomes were incident stroke, disability (modified Rankin Scale), and executive function (Trail Making Test B given A t-scores). Neuroimaging outcomes were mean skeletonized mean diffusivity (MSMD), normalized white matter hyperintensity volume (nWMHv), normalized lacune volume (nLV), and brain parenchymal fraction (BPF). Cox regression and mixed-effect models, adjusted for age, sex, and cardiovascular risk factors, were used to study 2-year changes in outcomes and differences in disease progression between patients with HR-NOTCH3 and MR-NOTCH3 variants. One hundred sixty-two patients with HR (n = 90), MR (n = 67), and LR (n = 5) NOTCH3 variants were included. For the entire cohort, there was 2-year mean progression for MSMD (β = 0.20, 95% CI 0.17-0.23, p = 7.0 × 10-24), nLV (β = 0.13, 95% CI 0.080-0.19, p = 2.1 × 10-6), nWMHv (β = 0.092, 95% CI 0.075-0.11, p = 8.8 × 10-20), and BPF (β = -0.22, 95% CI -0.26 to -0.19, p = 3.2 × 10-22), as well as an increase in disability (p = 0.002) and decline of executive function (β = -0.15, 95% CI -0.30 to -3.4 × 10-5, p = 0.05). The HR-NOTCH3 group had a higher probability of 2-year incident stroke (hazard ratio 4.3, 95% CI 1.4-13.5, p = 0.011), and a higher increase in MSMD (β = 0.074, 95% CI 0.013-0.14, p = 0.017) and nLV (β = 0.14, 95% CI 0.034-0.24, p = 0.0089) than the MR-NOTCH3 group. Subgroup analyses showed significant 2-year progression of MSMD in young (n = 17, β = 0.014, 95% CI 0.0093-0.019, p = 1.4 × 10-5) and premanifest (n = 24, β = 0.012, 95% CI 0.0082-0.016, p = 1.1 × 10-6) individuals. In a trial-sensitive time span of 2 years, we found that patients with HR-NOTCH3 variants have a significantly faster progression of major clinical and neuroimaging outcomes, compared with patients with MR-NOTCH3 variants. This has important implications for clinical trial design and disease prediction and monitoring in the clinic. Moreover, we show that MSMD is a promising outcome measure for trials enrolling premanifest individuals.

Pulmonary Function at Minimum 10 Years After Segmental Pedicle Screw Instrumentation for Thoracic Adolescent Idiopathic Scoliosis.

A prospective multi-center cohort study. This study evaluates the 10-year pulmonary function outcomes for patients with structural thoracic adolescent idiopathic scoliosis (Lenke curve types 1-4, 6) after segmental pedicle screw instrumentation. Adolescent idiopathic scoliosis with thoracic curves is associated with reduced pulmonary function preoperatively. It remains unclear how much pulmonary improvement can be obtained using pedicle screw instrumentation at long-term follow-up. Out of 64 consecutively surgically treated patients with thoracic AIS (Lenke 1-4, 6) using pedicle screw instrumentation, 50 (mean age at final FU 14.7 ± 1.9, 44 females) participated in a prospective 10-year follow-up study. They were evaluated using clinical examination, spinal radiographs, and spirometry preoperatively and at 10-year follow-up. The preoperative percentage predicted values were adjusted for the height loss caused by the scoliosis according to curve size. Preoperatively 49% (20/41) had forced vital capacity (FVC) or forced expiratory volume in one second (FEV1) below 80% of the predicted normal values representing pulmonary function impairment. Major curve correction averaged 76% (SD 9%). FVC improved from preoperative 3.29 L (SD 0.78L) to 3.87 L (0.79L) at 10-year follow-up (P<0.001). This improvement averaged 510mL (SD 560mL) in patients having both preoperative and 10-year follow-up measurements available. The percentage predicted values for FVC showed an improvement from 83% preoperatively to 86% at 10-year follow-up (P=0.048). At 10-year follow-up 38% (19/50) of the patients had FVC or FEV1 below 80% of the predicted values. FVC improved by a mean of 510ml from preoperative to 10-year follow-up in patients undergoing pedicle screw instrumentation for thoracic AIS. Despite 76% scoliosis correction and significant improvement of absolute lung volume values, more than one-third of these surgically treated otherwise healthy young adults fulfilled the criteria for pulmonary function impairment at 10-year follow-up. II.

Interbody Fusion Device in the Treatment of Cervicobrachial Syndrome: A Prospective 5-Year Follow-Up Extension Study of Porous Titanium Cervical Cages

Background: To assess long-term clinical and radiological data of porous titanium cervical interbody cages. Methods: We recruited 34 out of 49 patients previously enrolled in the EFFECT trial on 3D printed titanium cages, for 5 years follow-up. Objectives were the evaluation of Neck Disability Index, Visual Analog Scale of arm pain and neck pain, Likert self-reported perceived recovery, EQ-5D, fusion status and subsidence. Fusion was defined as rotation ≤ 4° and ≤ 1.25 mm translation at the index level, using flexion-extension radiograph. Results: All patients had good outcomes in terms of NDI (12.5±15.4), VAS neck pain (23.5±24.1), VAS arm pain (18.7±20.2) and EuroQol (0.77±0.24). 88.6% of the patients experienced complete or nearly complete recovery. NDI improved significantly at 5 years compared to 1 year, all other outcome measures did not significantly differ from the 12 months results. The fusion rate at the index level increased from 91.5% at 12 months to 100% at 5 years. Conclusion: 3D printed stand-alone porous titanium cervical implants are effective in terms of clinical and radiological outcome with 88.6% complete or nearly complete recovery and fusion rate of 100% at 5 years follow-up. Moreover, solid single level anterior cervical fusion can be achieved without additional plating. Trial Registration: The study has been registered in The Netherlands Trial Register (NTR 1289) and approved by the Medical Ethical Committee (NL76079.058.20).

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 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

Mortality in Patients with Acute Coronary Syndrome-A Prospective 5-Year Follow-Up Study.

Our objective was to compare long-term outcomes in patients with non-ST-elevation myocardial infarction (NSTEMI) and ST-elevation myocardial infarction (STEMI) between two time periods in Southern Norway. There are limited contemporary data comparing long-term follow-up after revascularization in the last decades. This prospective follow-up study consecutively included both NSTEMI and STEMI patients during two time periods, 2014-2015 and 2004-2009. Patients were followed up for a period of 5 years. The primary outcome was all-cause mortality after 1 and 5 years. A total of 539 patients with acute myocardial infarction (AMI), 316 with NSTEMI (234 included in 2014 and 82 included in 2007) and 223 with STEMI (160 included in 2014 and 63 included in 2004). Mortality after NSTEMI was high and remained unchanged during the two time periods (mortality rate at 1 year: 3.5% versus 4.9%, p = 0.50; and 5 years: 11.4% versus 14.6%, p = 0.40). Among STEMI patients, all-cause mortality at 1 year was reduced in 2014 compared to 2004 (1.3% versus 11.1%, p < 0.001; and 5 years: 7.0% versus 22.2%, p = 0.004, respectively). Time to coronary angiography in NSTEMI patients remained unchanged between 2014 and 2007 (28.2 h [IQR 18.1-46.3] versus 30.3 h [IQR 18.0-48.3], p = 0.20), while time to coronary angiography in STEMI patients was improved in 2014 compared with 2004 (2.8 h [IQR 2.0-4.8] versus 21.7 h [IQR 5.4-27.1], p < 0.001), respectively. During one decade of AMI treatment, mortality in patients with NSTEMI remained unchanged while mortality in STEMI patients decreased, both at 1 and 5 years.

Liraglutide treatment is associated with progression of coronary artery fibrous plaque: a prospective 1-year follow-up study in asymptomatic patients with type 2 diabetes

ObjectiveThe objective of this study was to assess the association between clinically indicated liraglutide treatment and coronary artery plaque progression during 1-year follow-up in asymptomatic diabetes.MethodsPatients were divided into a group receiving liraglutide (Lira+) and a group not receiving liraglutide (Lira-). Coronary computed tomography angiography (CCTA) was performed to assess total atheroma volume (TAV) and subtypes of plaque volumes (dense calcium, fibrous, fibrous-fatty, and necrotic core plaque) and the plaque progression during one year follow-up.ResultsFifty-five patients (27%) receiving liraglutide and 149 (73%) how did not were included. Changes in TAV during 1-year of follow-up were similar in the two groups (38 ± 180 (Lira+) vs. -1 ± 160 mm3 (Lira-), P = 0.13). A greater increase in fibrous plaque volume was seen in the Lira + vs. the Lira- group (34 ± 129 vs. -2 ± 101 mm3, P = 0.04). Changes over 1-year in the other plaque subtypes were similar in the two groups. Treatment duration of liraglutide was not associated with changes in TAV.ConclusionIn patients with T2D without known prior coronary artery disease, liraglutide treatment was associated with a significant increase in coronary artery fibrous plaque volume during 1-year follow-up.

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

Oral function and cumulative long-term care costs among older Japanese adults: a prospective 6-year follow-up study of long care receipt data

ObjectivesThis study evaluated the relationship between status of oral function and related long-term care service costs.DesignThis was a prospective 6-year follow-up study of previous survey data.SettingThe data were obtained from...

Primary constrained condylar knee arthroplasty in severe varus deformity: a prospective 5-year functional follow-up study in Iraqi patients.

The outcomes of the constrained condylar knee (CCK) implant used during primary total knee arthroplasty (TKA) in knees with severe varus in patients from low- and middle-income countries (LMICs) such as Iraq are not known. Hence, this study aimed to analyze and report the functional outcome of CCK TKA in patients with severe varus deformities at the end of 5 years in Iraqi patients. In this prospective study, pre- and post-operative (at the end of 5years) clinical outcome using Knee Society Score (KSS) and radiological deformity using hip-knee-ankle (HKA) angle was analyzed in 76 CCK TKAs (20 bilateral and 36 unilateral TKAs) performed in 56 patients with severe varus deformity (> 15°). At a mean follow-up of 60.3months (range 60-68months), the mean preoperative KSS knee score of 6.6 ± 4.5 improved significantly (p < 0.0001) to 87.2 ± 6.6 and the mean preoperative KSS function score of 7.1 ± 6.4 improved significantly (p < 0.0001) to 70.4 ± 7.8. The function score was good to excellent in 64.3% (36 patients), fair in 28.5% (16 patients), and poor in 7.1% (4 patients) at the end of 5years. The mean preoperative HKA angle significantly improved (p < 0.001) from 25.5° ± 6° varus (range 17°-37°) to 3° ± 2.5° varus (range 0°-7.5°) at final follow-up. The CCK implant significantly improved pain and function in patients with severe varus deformity at the end of 5years. The CCK implant is a good option during primary TKA in severe varus knees in patients from LMICs and can help achieve clinical outcomes similar to patients from high-income countries.

Impact of previous lumbar spine surgery on the outcome of lumbar total disc replacement: analysis of prospective 5-year follow-up study data.

It is sometimes anticipated that patients with prior spine surgery will have a compromised outcome from future procedures. The purpose of this study was to compare TDR outcomes in patients with prior lumbar spine surgery to those with no previous surgery. Post hoc analysis was performed on 5-year follow-up data collected prospectively in the multi-centre FDA-regulated trial for the activL® Artificial Disc which involved 376 patients treated for single-level symptomatic disc degeneration. Clinical outcome measures included the Oswestry Disability Index (ODI), visual analog scales (VAS) assessing back and leg pain, SF-36, adverse events, and re-operations. Radiographic outcomes included flexion/extension range of motion (ROM) and translation of the operated segment. Patients were divided into two groups: Prior Lumbar Surgery (PLS, n = 92) and No Prior Lumbar Surgery (NPLS, n = 284). Baseline demographics were similar in the two groups. ODI, VAS, and SF-36 Physical Component Scale scores improved significantly (p < 0.05) from baseline in both groups with improvements maintained through 5-year post-TDR with no significant differences between groups. There were no statistically significant differences in rates of serious device-related events, procedure-related events, or re-operations. While ROM was significantly less prior to TDR surgery in the PLS group, there was no significant difference in ROM at post-operative points. Prior lumbar spine surgery was not associated with compromised outcomes following TDR. These results are in line with reports from earlier studies with shorter follow-up, finding that non-destabilizing prior surgery is not a contra-indication for TDR provided that selection criteria are met. Diagnostic: individual cross-sectional studies with the consistently applied reference standard and blinding.

Is it really necessary to perform venous anastomosis in vascularized corticoperiosteal bone flap? A randomized prospective 4-year follow-up study

Is it really necessary to perform venous anastomosis in vascularized corticoperiosteal bone flap? A randomized prospective 4-year follow-up study

Surgical procedures in infants with early diagnoses of developmental dysplasia of the hip. A prospective 4-year follow-up study

BackgroundDysplastic hips infants may normalize spontaneously without any intervention due to the natural growth. However, some infants need one or more surgical interventions to achieve stable and non-dysplastic hips. The purpose of this study is to determine the proportion of infants diagnosed with DDH before the age of 6 months undergoing surgical procedures of the hip(s) before the age of four years and to determine the number and types of surgical procedures in each infant. MethodsA prospective and consecutive study of all infants aged 0–6 months diagnosed with dysplasia of the hips in the combined paediatric orthopaedic and radiologic examination in the Region of Southern Denmark 2013–2017. From medical records, we obtained information about all surgical procedures in the hips including open or closed reductions, arthrographies, tenotomies, and pelvic osteotomies before the age of 4 years. ResultsOverall, 281 infants with hip dysplasia were included. The median age at first examination was 48 days. In 254 (90%) of the infants, the hips resolved spontaneously, and 27 (10%) needed one or more surgical interventions. Overall, the 27 infants had 47 surgical intervention as 12 infants had more than one intervention. One infants had five surgical interventions. The most frequent surgical procedures were closed reduction and arthrography with or without adductor tenotomy (58%) and pelvic osteotomy (27%). Among infants with surgical interventions, 23 (8.2%) had unstable hips, and four (1.4%) had stable hips. All four infants with stable hips had an arthrography and none required a pelvic osteotomy. DiscussionThis study supports the propensity for spontaneous normalization early dysplasia of the hips in infants. Only a small proportion of the infants needed surgical interventions to achieve stable and non-dysplastic hips.

Bone mass and biomarkers in young women with anorexia nervosa: a prospective 3-year follow-up study

Anorexia nervosa (AN) increases the risk of impaired bone health, low areal bone mineral density (aBMD), and subsequent fractures. This prospective study investigated the long-term effects of bone and mineral metabolism on bone and biomarkers in 22 women with AN. Body composition and aBMD were measured by dual-energy X-ray absorptiometry (DXA) and peripheral quantitative computed tomography. Total and free 25-hydroxyvitamin D (25OHD), C-terminal collagen cross-links (CTX), osteocalcin, bone-specific alkaline phosphatase (BALP), leptin, sclerostin, and oxidized/non-oxidized parathyroid hormone (PTH) were analyzed before and after 12weeks of intensive nutrition therapy and again 3years later. An age-matched comparison group of 17 healthy women was recruited for the 3-year follow-up. Body mass index (BMI) and fat mass increased from baseline to 3years in women with AN. Sclerostin decreased during nutrition therapy and further over 3years, indicating reduced bone loss. CTX was elevated at baseline and after 12weeks but decreased over 3years. BALP increased during nutrition therapy and stabilized over 3years. Free 25OHD was stable during treatment but decreased over 3years. Non-oxidized PTH was stable during treatment but increased over 3years. Trabecular volumetric BMD in AN patients decreased during the first 12weeks and over 3years despite stable BMI and bone biomarkers implying increased BMD. Our findings highlight the importance of early detection and organized long-term follow-up of bone health in young women with a history of AN.

Regulatory and Clinical Expert Perspective of the 2022 FDA Draft Guidance “Celiac Disease: Developing Drugs for Adjunctive Treatment to a Gluten-Free Diet”

Regulatory and Clinical Expert Perspective of the 2022 FDA Draft Guidance “Celiac Disease: Developing Drugs for Adjunctive Treatment to a Gluten-Free Diet”

Is it really necessary to perform venous anastomosis in vascularized corticoperiosteal bone flap? A randomized prospective 4-year follow-up study

BackgroundThis study aims to investigate the treatment results of atrophic nonunion of the lower and upper limb with vascularized bone flaps performed with only arterial anastomosis versus the execution of flaps performed with arterial and venous anastomosis, comparing the surgical time and the healing rate of these two techniques. Methods49 patients were enrolled in this study and were randomly divided into two groups: group A, the control group, consisted of 27 patients, who underwent vascularized corticoperiosteal bone flap with both arterial and venous anastomosis; group B, consisted of 22 patients, who underwent vascularized corticoperiosteal bone flap with only arterial anastomosis. The surgical time, the time to harvest the graft and the microsurgical time were evaluated. Radiological and clinical follow-ups were performed with one independent and blinded investigator to avoid bias. ResultsA significant reduction in the duration of the intervention in group B was found: a 13.63% reduction of the total surgical time and a 41.75% reduction of the microsurgical time. A significant difference was not found between groups A and B in bone healing time. All the patients of both groups were able to return to their daily life activities. ConclusionsOur investigation suggests that it isn't necessary to perform the venous anastomosis between the flap pedicle and the recipient area. Presumably, the venous blood flow reaches the systemic circulation through the vascular bone marrow network. Our procedure avoids venous trauma during the dissection and execution of the anastomosis and, therefore, can minimize complications such as venous thrombosis.

Classification and Treatment for Cervical Spine Fracture with Ankylosing Spondylitis: A Clinical Nomogram Prediction Study.

Objective Through the follow-up analysis of cervical spine fracture cases with ankylosing spondylitis (AS), a treatment-oriented fracture classification method is introduced to evaluate the clinical efficacy guided by this classification method. Method A retrospective analysis was performed on 128 AS patients who underwent comprehensive treatment in the Spine Surgery Department of Qingdao University Hospital from January 2009 to May 2018. Statistics of patient demographic data, distribution of different fractures corresponding to surgical methods, 3-year follow-up outcomes, and summary of objective fracture classification methods were analyzed. A prospective 5-year follow-up study of 90 patients with AS cervical spine fractures from June 2015 to August 2020 was also included. Statistical differences on the distribution of factors such as case information, cervical spine sagittal sequence parameters, and fracture classification were assessed. Correlations between surgical information, American Spinal Injuries Association grade (ASIA), modified Japanese Orthopaedic Association scores (mJOA), and other factors were analyzed to establish a nomogram predictive model for curative effect outcomes. Overall, three major types and the four subtypes of AS cervical spine fractures were evaluated based on the clinical efficacy of the classification and the selection of surgical treatment methods. Result The most common type of fracture was type II (30 cases, 33.33%), most of the subtypes were A (37 cases), followed by B (36 cases) and C (17 cases). Twenty-four of 28 patients with type I underwent anterior surgery, and 47 of 62 patients with type II and III underwent posterior surgery. The average follow-up time was 25.76 ± 11.80 months. The results of predicting clinical variables are different but include factors such as fracture type and subtype, type of operation, and age. The predictor variables include the above-mentioned similar variables, but survival is more affected by the fracture type of the patient. Conclusion This predictive model based on follow-up information delineation points out the impact of ankylosing spondylitis cervical spine fracture classification on surgical selection and clinical efficacy.