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  1. Yahya N, Mohamad Salleh SA, Mohd Nasir NF, Abdul Manan H
    Asia Pac J Clin Oncol, 2024 Apr;20(2):240-250.
    PMID: 36683266 DOI: 10.1111/ajco.13915
    BACKGROUND: Proton and carbon-ion therapy may spare normal tissues in regions with many critical structures surrounding the target volume. As toxicity outcome data are emerging, we aimed to synthesize the published data for the toxicity outcomes of proton or carbon-ion therapy (together known as particle beam therapy [PBT]) for primary nasopharyngeal carcinoma (NPC).

    MATERIALS AND METHODS: We searched PubMed and Scopus electronic databases to identify original studies reporting toxicity outcomes following PBT of primary NPC. Quality assessment was performed using NIH's Quality Assessment Tool. Reports were extracted for information on demographics, main results, and clinical and dose factors correlates. Meta-analysis was performed using the random-effects model.

    RESULTS: Twelve studies were selected (six using mixed particle-photon beams, five performed comparisons to photon-based therapy). The pooled event rates for acute grade ≥2 toxicities mucositis, dermatitis, xerostomia weight loss are 46% (95% confidence interval [95% CI]-29%-64%, I2 = 87%), 47% (95% CI-28%-67%, I2 = 87%), 16% (95% CI-9%-29%, I2 = 76%), and 36% (95% CI-27%-47%, I2 = 45%), respectively. Only one late endpoint (xerostomia grade ≥2) has sufficient data for analysis with pooled event rate of 9% (95% CI-3%-29%, I2 = 77%), lower than intensity-modulated radiotherapy 27% (95% CI-10%-54%, I2 = 95%). For most endpoints with significant differences between the PBT and photon-based therapies, PBT resulted in better outcomes. In two studies where dose distribution was studied, doses to the organs at risk were independent risk factors for toxicities.

    CONCLUSION: PBT may reduce the risk of acute toxicities for patients treated for primary NPC, likely due to dose reduction to critical structures. The pooled event rate for toxicities derived in this study can be a guide for patient counseling.

    Matched MeSH terms: Follow-Up Studies
  2. Lo TS, Harun F, Chua S, Shen YH, Tan YL, Hsieh WC
    J Formos Med Assoc, 2024 Mar;123(3):331-339.
    PMID: 37996329 DOI: 10.1016/j.jfma.2023.11.003
    BACKGROUND AND PURPOSE: We present this current study to complement with mesh inlays plausible benefits (UPHOLD-LITE System) on available long-term study amidst FDA's concern on mesh complications. This study aims to assess the medium-term outcomes of UPHOLD-LITE system for treatment of advanced pelvic organ prolapse (POP) and its complications, and lower urinary tract symptoms.

    METHODS: This is a retrospective case series of 53 months follow-up of 123 consecutive patients who underwent UPHOLD-LITE system. Objective outcome measures the anatomical correction of prolapse with POP-Q ≤ Stage 1. Subjective outcome was patient's feedback to questions 2 and 3 of POPDI-6. Secondary outcome measures the quality of life, presence of lower urinary tract symptoms and complications. Quality of life is assessed by validated questionnaires on Urogenital Distress Inventory 6 (UDI-6), Incontinence Impact Questionnaire 7 (IIQ-7), Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6), and Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire 12 (PISQ-12) at 1 and 3 years post-operatively.

    RESULTS: Objective outcome at 1 and 3 years was at 96.7 % and 95.4 % respectively. The subjective cure was 95.1 % and 91.6 %. Five-year cumulative cure rate maintained at 87.2 %. Secondary outcomes observed improvement on UDI-6, IIQ-7, POPDI-6 and PISQ-12 postoperatively. Bladder outlet obstruction improved while de novo urodynamic stress incontinence (USI) increased slightly post surgically. Mesh erosion rate was 0.8 %.

    CONCLUSION: The UPHOLD-LITE system demonstrated good medium term anatomical correction of apical and anterior prolapse, with good subjective cure and improved quality of life. Whilst complication rate was low, slight increase in de novo USI was observed.

    Matched MeSH terms: Follow-Up Studies
  3. Leong MC, Hoo XY, Alwi M
    Cardiol Young, 2024 Jan;34(1):228-231.
    PMID: 38073568 DOI: 10.1017/S1047951123004055
    Amplatzer Vascular Plug IV (Abbott, USA) is usually used for the occlusion of abnormal tortuous vessels and has not been tried for the transcatheter closure of perimembranous ventricular septal defects with wind-sock morphology. Here, we report on three successful cases of perimembranous ventricular septal defect transcatheter closure using Amplatzer Vascular Plug IV. We did not observe residual shunting or new onset of complications during follow up. These preliminary positive results advocate the application and suitability of Amplatzer Vascular Plug IV for closing wind-sock-like perimembranous ventricular septal defects.
    Matched MeSH terms: Follow-Up Studies
  4. Wong LP, Tan SL, Alias H, Sia TE, Saw A
    Omega (Westport), 2023 Nov;88(1):157-170.
    PMID: 34490819 DOI: 10.1177/00302228211043613
    This study assessed death anxiety (Death Anxiety Questionnaire, DAQ) and psychophysical- (psychological and physical) symptom experience following cadaveric dissection among the Silent Mentor Program (SMP) participants before thawing (T1), after the suturing, dressing and coffining session (T2), and one month post-program (T3). There was a significant decline in the total DAQ score comparing T1 and T2 (t = 7.69, p 
    Matched MeSH terms: Follow-Up Studies
  5. Kim H, Kang DY, Ahn JM, Lee J, Choi Y, Hur SH, et al.
    JACC Cardiovasc Interv, 2023 Oct 09;16(19):2412-2422.
    PMID: 37821187 DOI: 10.1016/j.jcin.2023.07.028
    BACKGROUND: Diabetes mellitus is associated with more complex coronary artery diseases. Coronary artery bypass grafting (CABG) is a preferred revascularization strategy over percutaneous coronary intervention (PCI) in diabetics with multivessel coronary artery disease (MVD).

    OBJECTIVES: This study sought to examine the different prognostic effects of revascularization strategies according to the diabetes status from the randomized BEST (Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease) trial.

    METHODS: Patients (n = 880) with MVD were randomly assigned to undergo PCI with an everolimus-eluting stent vs CABG stratified by diabetics (n = 363) and nondiabetics (n = 517). The primary endpoint was the composite of death, myocardial infarction, or target vessel revascularization during a median follow-up of 11.8 years (IQR: 10.6-12.5 years).

    RESULTS: In diabetics, the primary endpoint rate was significantly higher in the PCI group than in the CABG group (43% and 32%; HR: 1.53; 95% CI: 1.12-2.08; P = 0.008). However, in nondiabetics, no significant difference was found between the groups (PCI group, 29%; CABG group, 29%; HR: 0.97; 95% CI: 0.67-1.39; P = 0.86; Pinteraction= 0.009). Irrespective of the presence of diabetes, no significant between-group differences were found in the rate of a safety composite of death, myocardial infarction, or stroke and mortality rate. However, the rate of any repeat revascularization was significantly higher in the PCI group than in the CABG group.

    CONCLUSIONS: In diabetics with MVD, CABG was associated with better clinical outcomes than PCI. However, the mortality rate was similar between PCI and CABG irrespective of diabetes status during an extended follow-up. (Ten-Year Outcomes of Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease [BEST Extended], NCT05125367; Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease [BEST], NCT00997828).

    Matched MeSH terms: Follow-Up Studies
  6. Tay AK, Mohsin M, Foo CYS, Rees S, Silove D
    Psychol Med, 2023 Oct;53(13):6055-6067.
    PMID: 36330832 DOI: 10.1017/S0033291722003245
    BACKGROUND: Long-term efficacy of brief psychotherapies for refugees in low-resource settings is insufficiently understood. Integrative adapt therapy (IAT) is a scalable treatment addressing refugee-specific psychosocial challenges.

    METHODS: We report 12-month post-treatment data from a single-blind, active-controlled trial (October 2017-August 2019) where 327 Myanmar refugees in Malaysia were assigned to either six sessions of IAT (n = 164) or cognitive behavioral treatment (CBT) (n = 163). Primary outcomes were posttraumatic stress disorder (PTSD), depression, anxiety, and persistent complex bereavement disorder (PCBD) symptom scores at treatment end and 12-month post-treatment. Secondary outcome was functional impairment.

    RESULTS: 282 (86.2%) participants were retained at 12-month follow-up. For both groups, large treatment effects for common mental disorders (CMD) symptoms were maintained at 12-month post-treatment compared to baseline (d = 0.75-1.13). Although participants in IAT had greater symptom reductions and larger effect sizes than CBT participants for all CMDs at treatment end, there were no significant differences between treatment arms at 12-month post-treatment for PTSD [mean difference: -0.9, 95% CI (-2.5 to 0.6), p = 0.25], depression [mean difference: 0.1, 95% CI (-0.6 to 0.7), p = 0.89), anxiety [mean difference: -0.4, 95% CI (-1.4 to 0.6), p = 0.46], and PCBD [mean difference: -0.6, 95% CI (-3.1 to 1.9), p = 0.65]. CBT participants showed greater improvement in functioning than IAT participants at 12-month post-treatment [mean difference: -2.5, 95% CI (-4.7 to -0.3], p = 0.03]. No adverse effects were recorded for either therapy.

    CONCLUSIONS: Both IAT and CBT showed sustained treatment gains for CMD symptoms amongst refugees over the 12-month period.

    Matched MeSH terms: Follow-Up Studies
  7. Özgüroğlu M, Kilickap S, Sezer A, Gümüş M, Bondarenko I, Gogishvili M, et al.
    Lancet Oncol, 2023 Sep;24(9):989-1001.
    PMID: 37591293 DOI: 10.1016/S1470-2045(23)00329-7
    BACKGROUND: Cemiplimab provided significant survival benefit to patients with advanced non-small-cell lung cancer with PD-L1 tumour expression of at least 50% and no actionable biomarkers at 1-year follow-up. In this exploratory analysis, we provide outcomes after 35 months' follow-up and the effect of adding chemotherapy to cemiplimab at the time of disease progression.

    METHODS: EMPOWER-Lung 1 was a multicentre, open-label, randomised, phase 3 trial. We enrolled patients (aged ≥18 years) with histologically confirmed squamous or non-squamous advanced non-small-cell lung cancer with PD-L1 tumour expression of 50% or more. We randomly assigned (1:1) patients to intravenous cemiplimab 350 mg every 3 weeks for up to 108 weeks, or until disease progression, or investigator's choice of chemotherapy. Central randomisation scheme generated by an interactive web response system governed the randomisation process that was stratified by histology and geographical region. Primary endpoints were overall survival and progression free survival, as assessed by a blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumours version 1.1. Patients with disease progression on cemiplimab could continue cemiplimab with the addition of up to four cycles of chemotherapy. We assessed response in these patients by BICR against a new baseline, defined as the last scan before chemotherapy initiation. The primary endpoints were assessed in all randomly assigned participants (ie, intention-to-treat population) and in those with a PD-L1 expression of at least 50%. We assessed adverse events in all patients who received at least one dose of their assigned treatment. This trial is registered with ClinicalTrials.gov, NCT03088540.

    FINDINGS: Between May 29, 2017, and March 4, 2020, we recruited 712 patients (607 [85%] were male and 105 [15%] were female). We randomly assigned 357 (50%) to cemiplimab and 355 (50%) to chemotherapy. 284 (50%) patients assigned to cemiplimab and 281 (50%) assigned to chemotherapy had verified PD-L1 expression of at least 50%. At 35 months' follow-up, among those with a verified PD-L1 expression of at least 50% median overall survival in the cemiplimab group was 26·1 months (95% CI 22·1-31·8; 149 [52%] of 284 died) versus 13·3 months (10·5-16·2; 188 [67%] of 281 died) in the chemotherapy group (hazard ratio [HR] 0·57, 95% CI 0·46-0·71; p<0·0001), median progression-free survival was 8·1 months (95% CI 6·2-8·8; 214 events occurred) in the cemiplimab group versus 5·3 months (4·3-6·1; 236 events occurred) in the chemotherapy group (HR 0·51, 95% CI 0·42-0·62; p<0·0001). Continued cemiplimab plus chemotherapy as second-line therapy (n=64) resulted in a median progression-free survival of 6·6 months (6·1-9·3) and overall survival of 15·1 months (11·3-18·7). The most common grade 3-4 treatment-emergent adverse events were anaemia (15 [4%] of 356 patients in the cemiplimab group vs 60 [17%] of 343 in the control group), neutropenia (three [1%] vs 35 [10%]), and pneumonia (18 [5%] vs 13 [4%]). Treatment-related deaths occurred in ten (3%) of 356 patients treated with cemiplimab (due to autoimmune myocarditis, cardiac failure, cardio-respiratory arrest, cardiopulmonary failure, septic shock, tumour hyperprogression, nephritis, respiratory failure, [n=1 each] and general disorders or unknown [n=2]) and in seven (2%) of 343 patients treated with chemotherapy (due to pneumonia and pulmonary embolism [n=2 each], and cardiac arrest, lung abscess, and myocardial infarction [n=1 each]). The safety profile of cemiplimab at 35 months, and of continued cemiplimab plus chemotherapy, was generally consistent with that previously observed for these treatments, with no new safety signals INTERPRETATION: At 35 months' follow-up, the survival benefit of cemiplimab for patients with advanced non-small-cell lung cancer was at least as pronounced as at 1 year, affirming its use as first-line monotherapy for this population. Adding chemotherapy to cemiplimab at progression might provide a new second-line treatment for patients with advanced non-small-cell lung cancer.

    FUNDING: Regeneron Pharmaceuticals and Sanofi.

    Matched MeSH terms: Follow-Up Studies
  8. Rambli R, Aznida FAA, Azimatun Noor A
    Med J Malaysia, 2023 Jul;78(4):449-457.
    PMID: 37518911
    INTRODUCTION: Teleconsultation gained popularity to provide safe medical care during the pandemic. However, literature on the sustainability of teleconsultation service at primary care beyond pandemic situations is scarce. This study aimed to determine the use of teleconsultation services for non-communicable disease (NCD) follow-up and explore the benefits and challenges of the service implementation during and beyond COVID-19 pandemic in Malaysia.

    MATERIALS AND METHODS: An exploratory qualitative study was conducted using videoconferencing. Fourteen medical officers working in public primary healthcare clinics from various regions of Malaysia were chosen using purposive sampling process, and participants underwent a total of seven paired in-depth interview (IDI) sessions. IDIs were video recorded, transcribed and subjected to interpretive thematic analysis.

    RESULTS: The two main themes which emerged were the benefits and challenges of NCD teleconsultation service. Various categories relating to benefits of teleconsultation for NCD care are as follows: (1) Improved efficiency for patient care delivery (improved effectiveness, convenient, improved safety, better disease monitoring, patient empowerment) and (2) Benefits for Health Care Providers (improved healthcare and service delivery). Main challenges identified were as follows: (1) Challenges for Delivery of Care (Patients' adaptation in using teleconsultation service, Patients abusing the system, Poor digital literacy, No proper disease monitoring record), (2) Challenges for Health Care Providers (Lack of dedicated team and training, Higher workload and time-consuming) and (3) Challenges for Health Care System (Institutional policy, legal and regulatory weakness, Medical record documentation and prescription updates).

    CONCLUSION: Optimisation of NCD patient healthcare delivery via teleconsultation is beneficial during and after pandemic. Targeted improvements to address current challenges are crucial to optimise its use beyond the pandemic period in the Malaysian public healthcare system.

    Matched MeSH terms: Follow-Up Studies
  9. Yoshino T, Cervantes A, Bando H, Martinelli E, Oki E, Xu RH, et al.
    ESMO Open, 2023 Jun;8(3):101558.
    PMID: 37236086 DOI: 10.1016/j.esmoop.2023.101558
    The European Society for Medical Oncology (ESMO) Clinical Practice Guidelines for the diagnosis, treatment and follow-up of patients with metastatic colorectal cancer (mCRC), published in late 2022, were adapted in December 2022, according to previously established standard methodology, to produce the Pan-Asian adapted (PAGA) ESMO consensus guidelines for the management of Asian patients with mCRC. The adapted guidelines presented in this manuscript represent the consensus opinions reached by a panel of Asian experts in the treatment of patients with mCRC representing the oncological societies of China (CSCO), Indonesia (ISHMO), India (ISMPO), Japan (JSMO), Korea (KSMO), Malaysia (MOS), the Philippines (PSMO), Singapore (SSO), Taiwan (TOS) and Thailand (TSCO), co-ordinated by ESMO and the Japanese Society of Medical Oncology (JSMO). The voting was based on scientific evidence and was independent of the current treatment practices, drug access restrictions and reimbursement decisions in the different Asian countries. The latter are discussed separately in the manuscript. The aim is to provide guidance for the optimisation and harmonisation of the management of patients with mCRC across the different countries of Asia, drawing on the evidence provided by both Western and Asian trials, whilst respecting the differences in screening practices, molecular profiling and age and stage at presentation, coupled with a disparity in the drug approvals and reimbursement strategies, between the different countries.
    Matched MeSH terms: Follow-Up Studies
  10. Pivot X, Cortés J, Lüftner D, Lyman GH, Curigliano G, Bondarenko IM, et al.
    JAMA Netw Open, 2023 Apr 03;6(4):e235822.
    PMID: 37022687 DOI: 10.1001/jamanetworkopen.2023.5822
    IMPORTANCE: Trastuzumab has been the standard of care for the treatment of patients with ERBB2-positive breast cancer; however, cardiac events have been reported. This long-term follow-up study provides clinical evidence supporting the similarity of a trastuzumab biosimilar (SB3) to reference trastuzumab (TRZ).

    OBJECTIVE: To compare cardiac safety and efficacy between SB3 and TRZ for patients with ERBB2-positive early or locally advanced breast cancer after up to 6 years of follow-up.

    DESIGN, SETTING, AND PARTICIPANTS: This prespecified secondary analysis of a randomized clinical trial, conducted from April 2016 to January 2021, included patients with ERBB2-positive early or locally advanced breast cancer from a multicenter double-blind, parallel-group, equivalence phase 3 randomized clinical trial of SB3 vs TRZ with concomitant neoadjuvant chemotherapy who completed neoadjuvant and adjuvant treatment.

    INTERVENTIONS: In the original trial, patients were randomized to either SB3 or TRZ with concomitant neoadjuvant chemotherapy for 8 cycles (4 cycles of docetaxel followed by 4 cycles of fluorouracil, epirubicin, and cyclophosphamide). After surgery, patients continued SB3 or TRZ monotherapy for 10 cycles of adjuvant treatment per previous treatment allocation. Following neoadjuvant and adjuvant treatment, patients were monitored for up to 5 years.

    MAIN OUTCOMES AND MEASURES: The primary outcomes were the incidence of symptomatic congestive heart failure and asymptomatic, significant decrease in left ventricular ejection fraction (LVEF). The secondary outcomes were event-free survival (EFS) and overall survival (OS).

    RESULTS: A total of 538 female patients were included (median age, 51 years [range, 22-65 years]). Baseline characteristics were comparable between the SB3 and TRZ groups. Cardiac safety was monitored for 367 patients (SB3, n = 186; TRZ, n = 181). Median follow-up was 68 months (range, 8.5-78.1 months). Asymptomatic, clinically significant LVEF decreases were rarely reported (SB3, 1 patient [0.4%]; TRZ, 2 [0.7%]). No patient experienced symptomatic cardiac failure or death due to a cardiovascular event. Survival was evaluated for the 367 patients in the cardiac safety cohort and an additional 171 patients enrolled after a protocol amendment (538 patients [SB3, n = 267; TRZ, n = 271]). No difference was observed in EFS or OS between treatment groups (EFS: hazard ratio [HR], 0.84; 95% CI, 0.58-1.20; P = .34; OS: HR, 0.61; 95% CI, 0.36-1.05; P = .07). Five-year EFS rates were 79.8% (95% CI, 74.8%-84.9%) in the SB3 group and 75.0% (95% CI, 69.7%-80.3%) in the TRZ group, and OS rates were 92.5% (95% CI, 89.2%-95.7%) in the SB3 group and 85.4% (95% CI, 81.0%-89.7%) in the TRZ group.

    CONCLUSIONS AND RELEVANCE: In this secondary analysis of a randomized clinical trial, SB3 demonstrated cardiac safety and survival comparable to those of TRZ after up to 6 years of follow-up in patients with ERBB2-positive early or locally advanced breast cancer.

    TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02771795.

    Matched MeSH terms: Follow-Up Studies
  11. Lazaro B, Sardi JP, Smith JS, Kelly MP, Yanik EL, Dial B, et al.
    J Neurosurg Spine, 2023 Mar 01;38(3):319-330.
    PMID: 36334285 DOI: 10.3171/2022.9.SPINE22549
    OBJECTIVE: Proximal junctional failure (PJF) is a severe form of proximal junctional kyphosis. Previous reports on PJF have been limited by heterogeneous cohorts and relatively short follow-ups. The authors' objectives herein were to identify risk factors for PJF and to assess its long-term incidence and revision rates in a homogeneous cohort.

    METHODS: The authors reviewed data from the Adult Symptomatic Lumbar Scoliosis 1 trial (ASLS-1), a National Institutes of Health-sponsored prospective multicenter study. Inclusion criteria were an age ≥ 40 years, ASLS (Cobb angle ≥ 30° and Oswestry Disability Index [ODI] ≥ 20 or Scoliosis Research Society revised 22-item questionnaire [SRS-22r] score ≤ 4.0 in pain, function, or self-image domains), and primary thoracolumbar fusion/fixation to the sacrum/pelvis of ≥ 7 levels. PJF was defined as a postoperative proximal junctional angle (PJA) change > 20°, fracture of the uppermost instrumented vertebra (UIV) or UIV+1 with > 20% vertebral height loss, spondylolisthesis of UIV/UIV+1 > 3 mm, or UIV screw dislodgment.

    RESULTS: One hundred sixty patients (141 women) were included in this analysis and had a median age of 62 years and a mean follow-up of 4.3 years (range 0.1-6.1 years). Forty-six patients (28.8%) had PJF at a median of 0.92 years (IQR 0.14, 1.23 years) following surgery. Based on Kaplan-Meier analyses, PJF rates at 1, 2, 3, and 4 years were 14.4%, 21.9%, 25.9%, and 27.4%, respectively. On univariate analysis, PJF was associated with greater age (p = 0.0316), greater body mass index (BMI; p = 0.0319), worse baseline patient-reported outcome measures (PROMs; ODI, SRS-22r, and SF-12 Physical Component Summary [PCS]; all p < 0.04), the use of posterior column osteotomies (PCOs; p = 0.0039), and greater postoperative thoracic kyphosis (TK; p = 0.0031) and PJA (p < 0.001). The use of UIV hooks was protective against PJF (p = 0.0340). On regression analysis (without postoperative measures), PJF was associated with greater BMI (HR 1.077, 95% CI 1.007-1.153, p = 0.0317), lower preoperative PJA (HR 0.607, 95% CI 0.407-0.906, p = 0.0146), and greater preoperative TK (HR 1.362, 95% CI 1.082-1.715, p = 0.0085). Patients with PJF had worse PROMs at the last follow-up (ODI, SRS-22r subscore and self-image, and SF-12 PCS; p < 0.04). Sixteen PJF patients (34.8%) underwent revision, and PJF recurred in 3 (18.8%).

    CONCLUSIONS: Among 160 primary ASLS patients with a median age of 62 years and predominant coronal deformity, the PJF rate was 28.8% at a mean 4.3-year follow-up, with a revision rate of 34.8%. On univariate analysis, PJF was associated with a greater age and BMI, worse baseline PROMs, the use of PCOs, and greater postoperative TK and PJA. The use of UIV hooks was protective against PJF. On multivariate analysis (without postoperative measures), a higher risk of PJF was associated with greater BMI and preoperative TK and lower preoperative PJA.

    Matched MeSH terms: Follow-Up Studies
  12. Sardi JP, Lazaro B, Smith JS, Kelly MP, Dial B, Hills J, et al.
    J Neurosurg Spine, 2023 Feb 01;38(2):217-229.
    PMID: 36461845 DOI: 10.3171/2022.8.SPINE22423
    OBJECTIVE: Previous reports of rod fracture (RF) in adult spinal deformity are limited by heterogeneous cohorts, low follow-up rates, and relatively short follow-up durations. Since the majority of RFs present > 2 years after surgery, true occurrence and revision rates remain unclear. The objectives of this study were to better understand the risk factors for RF and assess its occurrence and revision rates following primary thoracolumbar fusions to the sacrum/pelvis for adult symptomatic lumbar scoliosis (ASLS) in a prospective series with long-term follow-up.

    METHODS: Patient records were obtained from the Adult Symptomatic Lumbar Scoliosis-1 (ASLS-1) database, an NIH-sponsored multicenter, prospective study. Inclusion criteria were as follows: patients aged 40-80 years undergoing primary surgeries for ASLS (Cobb angle ≥ 30° and Oswestry Disability Index ≥ 20 or Scoliosis Research Society-22r ≤ 4.0 in pain, function, and/or self-image) with instrumented fusion of ≥ 7 levels that included the sacrum/pelvis. Patients with and without RF were compared to assess risk factors for RF and revision surgery.

    RESULTS: Inclusion criteria were met by 160 patients (median age 62 years, IQR 55.7-67.9 years). At a median follow-up of 5.1 years (IQR 3.8-6.6 years), there were 92 RFs in 62 patients (38.8%). The median time to RF was 3.0 years (IQR 1.9-4.54 years), and 73% occurred > 2 years following surgery. Based on Kaplan-Meier analyses, estimated RF rates at 2, 4, 5, and 8 years after surgery were 11%, 24%, 35%, and 49%, respectively. Baseline radiographic, clinical, and demographic characteristics were similar between patients with and without RF. In Cox regression models, greater postoperative pelvic tilt (HR 1.895, 95% CI 1.196-3.002, p = 0.0065) and greater estimated blood loss (HR 1.02, 95% CI 1.005-1.036, p = 0.0088) were associated with increased risk of RF. Thirty-eight patients (61% of all RFs) underwent revision surgery. Bilateral RF was predictive of revision surgery (HR 3.52, 95% CI 1.8-6.9, p = 0.0002), while patients with unilateral nondisplaced RFs were less likely to require revision (HR 0.39, 95% CI 0.18-0.84, p = 0.016).

    CONCLUSIONS: This study provides what is to the authors' knowledge the highest-quality data to date on RF rates following ASLS surgery. At a median follow-up of 5.1 years, 38.8% of patients had at least one RF. Estimated RF rates at 2, 4, 5, and 8 years after surgery were 11%, 24%, 35%, and 49%, respectively. Greater estimated blood loss and postoperative pelvic tilt were significant risk factors for RF. These findings emphasize the importance of long-term follow-up to realize the true prevalence and cumulative incidence of RF.

    Matched MeSH terms: Follow-Up Studies
  13. Su X, Lin Y, Liu L, Mei H, Xu A, Zeng C, et al.
    J Pediatr Endocrinol Metab, 2023 Jan 27;36(1):74-80.
    PMID: 36433712 DOI: 10.1515/jpem-2022-0372
    OBJECTIVES: Congenital generalized lipodystrophy (CGL) is a group of rare autosomal inherited diseases characterized by a widespread loss of adipose tissue. The main purpose of this study was to evaluate the features of Chinese patients with CGL2.

    METHODS: Three patients diagnosed with CGL2 from our center were reviewed. Data on clinical features, results of laboratory analyses, and previous treatments were retrospectively collected. This study also reviewed studies that reported patients diagnosed with CGL2 in the last 30 years.

    RESULTS: All patients presented a lack of subcutaneous fat, hypertriglyceridemia, reversed triangular faces, acanthosis nigricans, and hepatomegaly within the first six months of life. All three patients developed splenomegaly, and mental retardation in later life. Dietary control dramatically lowered triglyceride levels in all patients. One patient presented with diabetes mellitus at 1 year-old. Although combined therapy with low fat diet and metformin maintained normal levels of blood lipid and glucose, this patient developed hypertrophic cardiomyopathy at the age of three. By a literature review on all Chinese cases with CGL2, it is known that classic manifestations such as hypertriglyceridemia, hepatomegaly and diabetes mellitus can occur shortly after birth, and early diagnosis and treatment can improve quality of life. In this cohort, the most frequent variations are c.782dupG and c.974dup in the BSCL2 gene. However, the same genotype may have different clinical phenotypes in patients with CGL2.

    CONCLUSIONS: This study not only described the clinical and genetic features of three patients with CGL2 in China, but also reviewed literature about CGL2 around the world.

    Matched MeSH terms: Follow-Up Studies
  14. Nguyen TN, Qureshi MM, Klein P, Yamagami H, Mikulik R, Czlonkowska A, et al.
    Neurology, 2023 Jan 24;100(4):e408-e421.
    PMID: 36257718 DOI: 10.1212/WNL.0000000000201426
    BACKGROUND AND OBJECTIVES: Declines in stroke admission, IV thrombolysis (IVT), and mechanical thrombectomy volumes were reported during the first wave of the COVID-19 pandemic. There is a paucity of data on the longer-term effect of the pandemic on stroke volumes over the course of a year and through the second wave of the pandemic. We sought to measure the effect of the COVID-19 pandemic on the volumes of stroke admissions, intracranial hemorrhage (ICH), IVT, and mechanical thrombectomy over a 1-year period at the onset of the pandemic (March 1, 2020, to February 28, 2021) compared with the immediately preceding year (March 1, 2019, to February 29, 2020).

    METHODS: We conducted a longitudinal retrospective study across 6 continents, 56 countries, and 275 stroke centers. We collected volume data for COVID-19 admissions and 4 stroke metrics: ischemic stroke admissions, ICH admissions, IVT treatments, and mechanical thrombectomy procedures. Diagnoses were identified by their ICD-10 codes or classifications in stroke databases.

    RESULTS: There were 148,895 stroke admissions in the 1 year immediately before compared with 138,453 admissions during the 1-year pandemic, representing a 7% decline (95% CI [95% CI 7.1-6.9]; p < 0.0001). ICH volumes declined from 29,585 to 28,156 (4.8% [5.1-4.6]; p < 0.0001) and IVT volume from 24,584 to 23,077 (6.1% [6.4-5.8]; p < 0.0001). Larger declines were observed at high-volume compared with low-volume centers (all p < 0.0001). There was no significant change in mechanical thrombectomy volumes (0.7% [0.6-0.9]; p = 0.49). Stroke was diagnosed in 1.3% [1.31-1.38] of 406,792 COVID-19 hospitalizations. SARS-CoV-2 infection was present in 2.9% ([2.82-2.97], 5,656/195,539) of all stroke hospitalizations.

    DISCUSSION: There was a global decline and shift to lower-volume centers of stroke admission volumes, ICH volumes, and IVT volumes during the 1st year of the COVID-19 pandemic compared with the prior year. Mechanical thrombectomy volumes were preserved. These results suggest preservation in the stroke care of higher severity of disease through the first pandemic year.

    TRIAL REGISTRATION INFORMATION: This study is registered under NCT04934020.

    Matched MeSH terms: Follow-Up Studies
  15. Wai YZ, Pee XK, Lai YP, Alias R
    Med J Malaysia, 2023 Jan;78(1):74-78.
    PMID: 36715195
    INTRODUCTION: This study aims to compare the 2-year graft survival and outcomes of descemet stripping endothelial keratoplasty (DSEK) and penetrating keratoplasty (PK) for the treatment of bullous keratopathy (BK) among multiethnic Malaysia populations treated at a Tertiary Eye Centre in Kuala Lumpur, Malaysia.

    MATERIALS AND METHODS: This was a retrospective study of BK or Fuchs endothelial dystrophy (FED) patients who underwent DSEK or PK from 2015 to 2019 in Kuala Lumpur Hospital with a minimal post-operative follow-up of 2 years. Outcome measures included best-corrected visual acuity (BCVA), graft survival and complications. A total of 26 DSEK cases and 32 PK cases were included.

    RESULTS: At 2 years, graft survival rates were quite similar in two groups (DSEK 80.8% vs PK 75%, p=0.765). The mean follow-up period was 35.2 months in DSEK and 31.4 months for PK (p=0.465). The cumulative survival rates were slightly higher in the DSEK group (DSEK 73.1% vs PK 53.1%, p=0.119), but the result was not statistically significant. Postoperative complications were associated with higher graft failure in both groups (p=0.019). DSEK group has better post-operative BCVA (LogMAR DSEK 0.42 vs PK 0.83, p=0.003).

    CONCLUSION: Similar graft survival rates were observed with both corneal transplant techniques for 2 years among Malaysian patients with BK. Post-operative complications can cause a higher risk of graft failure. DSEK produced better post-operative BCVA compared to PK.

    Matched MeSH terms: Follow-Up Studies
  16. Looi MC, Idris Z, Kumaran T, Thyagarajan D, Abdullah JM, Ghani ARI, et al.
    J Neurotrauma, 2023 Jan;40(1-2):94-101.
    PMID: 36017631 DOI: 10.1089/neu.2022.0031
    Traumatic brain injury (TBI) is one the major causes of death and morbidity in developing countries, where depression is a common psychiatric condition among individuals with TBI. The objectives were to investigate the occurrence and severity of depression one-year post-TBI; the association between radiological findings and depression; and the risk factors. We report a cross-sectional study among adult patients who were hospitalized because of TBI in the past one year. A structured data collection form was used to collect patients' demographic data during TBI, while the Patient Health Questionnaire (PHQ)-9 questionnaire was administered to assess the level of depression at one-year post-TBI. Of the 309 patients in this study; 46.6%, 26.2%, and 27.2% had mild, moderate, and severe TBI, respectively. The overall rate of depression was 33.7%, where 22.3%, 8.7%, and 2.6% had mild, moderate, and moderately severe depression, respectively. There was a significant, positive correlation between severity of TBI and level of depression; rs (0.427), p 
    Matched MeSH terms: Follow-Up Studies
  17. Sharani ZZ, Ismail N, Yasin SM, Isa MR, Razali A, Sherzkawee MA, et al.
    PLoS One, 2023;18(6):e0287374.
    PMID: 37319310 DOI: 10.1371/journal.pone.0287374
    INTRODUCTION: Loss to follow-up (LTFU) and smoking during TB treatment are major challenges for TB control programs. Smoking increases the severity and prolongs TB treatment duration, which lead to a higher rate of LTFU. We aim to develop a prognostic scoring tool to predict LTFU among TB patients who smoke to improve successful TB treatment outcomes.

    MATERIALS AND METHODS: The development of the prognostic model utilized prospectively collected longitudinal data of adult TB patients who smoked in the state of Selangor between 2013 until 2017, which were obtained from the Malaysian Tuberculosis Information System (MyTB) database. Data were randomly split into development and internal validation cohorts. A simple prognostic score (T-BACCO SCORE) was constructed based on the regression coefficients of predictors in the final logistic model of the development cohort. Estimated missing data was 2.8% from the development cohort and was completely at random. Model discrimination was determined using c-statistics (AUCs), and calibration was based on the Hosmer and Lemeshow goodness of fit test and calibration plot.

    RESULTS: The model highlights several variables with different T-BACCO SCORE values as predictors for LTFU among TB patients who smoke (e.g., age group, ethnicity, locality, nationality, educational level, monthly income level, employment status, TB case category, TB detection methods, X-ray categories, HIV status, and sputum status). The prognostic scores were categorized into three groups that predict the risk for LTFU: low-risk (<15 points), medium-risk (15 to 25 points) and high-risk (> 25 points). The model exhibited fair discrimination with a c-statistic of 0.681 (95% CI 0.627-0.710) and good calibration with a nonsignificant chi-square Hosmer‒Lemeshow's goodness of fit test χ2 = 4.893 and accompanying p value of 0.769.

    CONCLUSION: Predicting LTFU among TB patients who smoke in the early phase of TB treatment is achievable using this simple T-BACCO SCORE. The applicability of the tool in clinical settings helps health care professionals manage TB smokers based on their risk scores. Further external validation should be carried out prior to use.

    Matched MeSH terms: Follow-Up Studies
  18. Md MY, Md CG, Md CW, MSc YC, MSc HJ, Md IH, et al.
    Int J Med Sci, 2023;20(8):1115-1122.
    PMID: 37484806 DOI: 10.7150/ijms.85777
    Purpose: Intradiscal biacuplasty (IDB) has been proven to be effective for treating lumbar degenerative disc disease (DDD). However, there has not been a reported prognostic factor for IDB. The present study meticulously evaluates the general and radiographic features that may serve as markers for predicting the therapeutic outcome of IDB. Methods: A prospective case series study was conducted, following time-series analysis moving averages models, with forty-one patients suffering from chronic discogenic lower back pain for more than six months. These patients subsequently received lumbar cool radiofrequency IDB and were enrolled in the study. Thirty-seven patients completed follow-up questionnaires at 1, 3, 6, and 12 months. The surgical outcomes were reported using visual analogue scale (VAS), Oswestry disability index (ODI), and the consumption of nonsteroidal anti-inflammatory drugs (NSAID). Furthermore, a univariate analysis was performed to identify prognostic factors associated with pain relief from age, gender, body mass index (BMI), and pre-operative lumbar magnetic resonance imaging reading. Results: Significant reductions were found in estimated VAS and ODI at the post-operative period at 1, 3, 6, and 12 months (P < 0.001). The NSAID dosage was significantly decreased at 3-month and 1-year follow-up (P < 0.05). No procedure-related complications were detected. The prognosis of IDB was not related to disc height, Pfirrmann grading or Modic endplate change. However, disc extrusions were associated with promising outcomes (VAS improvement ≥ 50%) on pain relief (P < 0.05). Conclusion: IDB is a good alternative choice for treating lumbar DDD. Patients with a painful extrusion lumbar disc may gain some benefits after receiving IDB following a period of failed conservative treatment. These findings may also add some references for physicians in the decision making when treating lumbar DDD.
    Matched MeSH terms: Follow-Up Studies
  19. Khor LA, A Wahid UNI, Ling LL, Liansim SMS, Oon J, Balakrishnan MN, et al.
    PLoS One, 2023;18(3):e0282733.
    PMID: 36877714 DOI: 10.1371/journal.pone.0282733
    INTRODUCTION: Tuberculosis remains a major health problem globally and in Malaysia, particularly in the state of Sabah. Delayed sputum conversion is associated with treatment failure, drug-resistant tuberculosis and mortality. We aimed to determine the prevalence of delayed sputum conversion among smear positive pulmonary tuberculosis (PTB) patients and its associated factors in Sabah, Malaysia.

    METHODS: A retrospective follow up study on all patients newly diagnosed with smear positive pulmonary tuberculosis from 2017 to 2019 was conducted at three government health clinics in Sabah, utilizing data from a national electronic tuberculosis database and medical records. Descriptive statistics and binary logistic regression were applied for data analysis. The outcome of the study was the sputum conversion status at the end of the two-month intensive treatment phase with either successful conversion to smear negative or non-conversion.

    RESULTS: 374 patients were included in the analysis. Our patients were generally younger than 60 years old with no medical illness and varying proportions of tuberculosis severity as judged by radiographic appearance and sputum bacillary load upon diagnosis. Foreigners constituted 27.8% of our sample. 8.8% (confidence interval: 6.2-12.2) did not convert to smear negative at the end of the intensive phase. Binary logistic regression showed that older patients ≥60 years old (adjusted odds ratio, AOR = 4.303), foreigners (AOR = 3.184) and patients with higher sputum bacillary load at diagnosis [2+ (AOR = 5.061) and 3+ (AOR = 4.992)] were more likely to have delayed sputum smear conversion.

    CONCLUSION: The prevalence of delayed sputum conversion in our study was considerably low at 8.8% with age ≥60 years old, foreigners and higher pre-treatment sputum bacillary load associated with delayed conversion. Healthcare providers should take note of these factors and ensure the patients receive proper follow up treatment.

    Matched MeSH terms: Follow-Up Studies
  20. Aladily TN, Khader M, Bustami N, Bazzeh F
    Malays J Pathol, 2022 Dec;44(3):517-521.
    PMID: 36591719
    Anaplastic large cell lymphoma, ALK-positive is a mature T-cell neoplasm that accounts for 10- 20% of paediatric non-Hodgkin lymphoma. Its frequency in infants and very young children is exceedingly rare and was rarely documented in the literature. The disease prognosis in this agegroup is unknown. We report two male patients who were diagnosed with ALCL-ALK(+) at the ages of 12 and 14 months, both presented with fever and leukemoid reaction, one was in stage I and the other in stage IV diseases. They were treated with APO-based chemotherapy and remained in complete remission for more than 7 years. To our knowledge, this is the first report that describes the long-term survival of ALCL-ALK(+) at very young age.
    Matched MeSH terms: Follow-Up Studies
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