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1.
Actas urol. esp ; 48(1): 25-41, Ene-Febr. 2024. tab, graf
Article in English, Spanish | IBECS | ID: ibc-229104

ABSTRACT

Introducción La litiasis renal (LR) es una enfermedad urológica común, que a menudo requiere de cuidados a largo plazo. Las tecnologías de salud móvil (m-Salud) y salud electrónica (e-Salud) tienen el potencial de mejorar el manejo de las enfermedades crónicas e impactar sobre los patrones de la conducta. Para evaluar la aplicabilidad de estas herramientas en la mejora del tratamiento y la prevención de la LR, nos propusimos evaluar los datos actuales sobre el uso, los beneficios y las limitaciones de la m-Salud y la e-Salud en la LR. Métodos Se realizó una revisión sistemática de los estudios de investigación primaria sobre m-Salud y e-Salud en la evaluación y tratamiento de la LR. Dos investigadores independientes examinaron las citas por título y resumen para determinar su pertinencia y, a continuación, se realizó una revisión del texto completo para obtener un resumen descriptivo de los estudios. Resultados Se incluyeron 37 artículos para el análisis. Las principales áreas de interés fueron: 1) botellas de agua «inteligentes» y aplicaciones de dispositivos móviles para el seguimiento del consumo de líquidos, que mostraron un aumento de la ingesta en la mayoría de los estudios; 2) plataformas de seguimiento de stent ureterales, que mejoraron la tasa de stent retenidos a largo plazo; 3) clínicas virtuales para el tratamiento de la LR, las cuales han mejorado el acceso, han reducido costes y han mostrado resultados satisfactorios; 4) plataformas de endoscopia para teléfonos inteligentes, que ofrecieron una buena calidad de imagen respecto a sus costes en entornos de recursos limitados, y 5) información sobre la LR en línea para pacientes, la cual generalmente se caracterizó por ser de mala calidad y/o precisión, particularmente en YouTube®. La mayoría de los estudios eran pruebas de concepto o estudios de intervención de un solo brazo, con una evaluación limitada de la eficacia o de los resultados clínicos a largo plazo. Conclusiones ... (AU)


Introduction Kidney stone disease (KSD) is a common urological condition that often requires long-term care. Mobile health (mHealth) and eHealth technologies have the potential to enhance chronic disease management and behavioral change. To assess opportunities to apply these tools to improve KSD treatment and prevention, we aimed to assess current evidence on the use, benefits, and limitations of mHealth and eHealth in KSD. Methods We performed a systematic review of primary research studies of mHealth and eHealth in the evaluation and management of KSD. Two independent researchers screened citations by title and abstract for relevance, then full-text review was performed for descriptive summary of the studies. Results A total of 37 articles were included for analysis. Primary domains of evidence included: 1) “smart” water bottles and mobile-device apps for tracking fluid consumption, which showed increased intake in most studies; 2) ureteral stent tracking platforms, which improved the rate of long-term retained stents; 3) virtual stone clinics, which have been suggested to increase access, lower costs, and have satisfactory outcomes; 4) smartphone-based endoscopy platforms, which offered cost-effective image quality in resource-limited settings; 5) patient information about KSD online, which was typically characterized as poor quality and/or accuracy, particularly on YouTube. Most studies were proof-of-concept or single-arm intervention designs, with limited assessment of effectiveness or long-term clinical outcomes. Conclusions Mobile and eHealth technologies have significant real-world applications to KSD prevention, intervention, and patient education. A lack of rigorous effectiveness studies currently limits evidence-based conclusions and incorporation in clinical guidelines. (AU)


Subject(s)
Medical Informatics Applications , Nephrolithiasis/prevention & control , Telemedicine/instrumentation , Telemedicine/trends
2.
Actas Urol Esp (Engl Ed) ; 48(1): 25-41, 2024.
Article in English, Spanish | MEDLINE | ID: mdl-37364768

ABSTRACT

INTRODUCTION: Kidney stone disease (KSD) is a common urological condition that often requires long-term care. Mobile health (mHealth) and eHealth technologies have the potential to enhance chronic disease management and behavioral change. To assess opportunities to apply these tools to improve KSD treatment and prevention, we aimed to assess current evidence on the use, benefits, and limitations of mHealth and eHealth in KSD. METHODS: We performed a systematic review of primary research studies of mHealth and eHealth in the evaluation and management of KSD. Two independent researchers screened citations by title and abstract for relevance, then full-text review was performed for descriptive summary of the studies. RESULTS: A total of 37 articles were included for analysis. Primary domains of evidence included: 1) "smart" water bottles and mobile-device apps for tracking fluid consumption, which showed increased intake in most studies; 2) ureteral stent tracking platforms, which improved the rate of long-term retained stents; 3) virtual stone clinics, which have been suggested to increase access, lower costs, and have satisfactory outcomes; 4) smartphone-based endoscopy platforms, which offered cost-effective image quality in resource-limited settings; 5) patient information about KSD online, which was typically characterized as poor quality and/or accuracy, particularly on YouTube. Most studies were proof-of-concept or single-arm intervention designs, with limited assessment of effectiveness or long-term clinical outcomes. CONCLUSIONS: Mobile and eHealth technologies have significant real-world applications to KSD prevention, intervention, and patient education. A lack of rigorous effectiveness studies currently limits evidence-based conclusions and incorporation in clinical guidelines.


Subject(s)
Kidney Calculi , Mobile Applications , Telemedicine , Humans , Smartphone , Delivery of Health Care
3.
Int J Oral Maxillofac Surg ; 52(3): 283-290, 2023 Mar.
Article in English | MEDLINE | ID: mdl-35851181

ABSTRACT

Maxillary oral squamous cell carcinoma (OSCC) is uncommon. Surgical resection is challenging due to the anatomy, and the role of elective neck dissection (END) is not well-defined. A retrospective cohort study of patients with maxillary OSCC treated with primary surgery between 2007 and 2019 was conducted. Primary tumours of sinonasal origin with extension into the oral cavity were excluded. Survival analysis was performed using Kaplan-Meier and Cox proportional hazards models. Sixty-seven patients were included; mean follow-up was 55 months. On univariate analysis, clear (≥5 mm) margins were associated with higher disease-free (68% vs 36%, P = 0.019) and overall survival (75% vs 36%, P = 0.004) than close/involved (<5 mm) margins. In clinically node-negative patients, the risk of occult cervical metastasis in tumours with depth of invasion (DOI) ≥ 3 mm and T2-4 tumours was 22% and 25%, respectively. END in these groups was associated with a lower rate of loco-regional recurrence (DOI ≥3 mm subgroup: 5% vs 38%, P = 0.029; T2-4 subgroup: 6% vs 50%, P = 0.028) and longer time to recurrence (DOI ≥3 mm subgroup: 119 months vs 96 months, P = 0.042; T2-4 subgroup: 117 months vs 56 months, P = 0.031) than observation of the neck. On multivariate analysis, close/involved margins were associated with an increased risk of overall mortality (hazard ratio 3.4, 95% confidence interval 1.0-11.3, P = 0.043) and disease recurrence (hazard ratio 2.8, 95% confidence interval 1.1-7.1, P = 0.031). In maxillary OSCC, a ≥ 5 mm histological margin should remain the goal of ablative surgery. END should be considered in tumours with DOI ≥ 3 mm.


Subject(s)
Carcinoma, Squamous Cell , Head and Neck Neoplasms , Mouth Neoplasms , Humans , Squamous Cell Carcinoma of Head and Neck/surgery , Carcinoma, Squamous Cell/pathology , Mouth Neoplasms/surgery , Mouth Neoplasms/pathology , Neck Dissection , Retrospective Studies , Margins of Excision , Neoplasm Staging , Neoplasm Recurrence, Local/pathology , Head and Neck Neoplasms/surgery
4.
Acta Orthop Belg ; 89(4): 619-623, 2023 Dec.
Article in English | MEDLINE | ID: mdl-38205751

ABSTRACT

Intraoperative femoral fracture is a common complication during cementless total hip arthroplasty (THA). Cerclage wiring has been used for this type of fractures to attain intraoperative stability of the femoral stem. We designed a new technique to treat Mallory type 1 intraoperative femoral fractures. We excised fractured femoral neck fragment and without additional fixation and lightly tapped down the femoral stem to obtain a tight contact to the femoral cortex at the subtrochanteric level. In this case series, we described this technique and reported its outcomes. From January 2015 to December 2017, 600 cementless THAs (557 patients) were done with use of a proximally coated tapered stem design at our department. Among the 600 THAs, Mallory type 1 intraoperative femoral fracture occurred in 8 hips (8 patients), and all of them were treated with the excision of the fractured femoral neck. Mean age of the 8 patients was 58.1 years (range, 30.4 to 81.3 years) at the time of surgery. We report the results of this new technique at postoperative 2 to 5 years (mean, 3.4 years). All stems were placed in the neutral position. There was no revision and no stem showed any evidence of subsidence or loosening during the follow-up. The mean Harris hip score was 85.9 points at the latest follow-up. We recommend to use the femoral neck excision technique for the treatment of Mallory type 1 intraoperative femoral fractures.


Subject(s)
Arthroplasty, Replacement, Hip , Femoral Fractures , Humans , Adult , Middle Aged , Aged , Aged, 80 and over , Femur Neck , Arthroplasty, Replacement, Hip/adverse effects , Femur , Fracture Fixation, Internal
5.
Int J Oral Maxillofac Surg ; 50(5): 585-590, 2021 May.
Article in English | MEDLINE | ID: mdl-32917484

ABSTRACT

The contemporary literature is discordant regarding the role of delayed diagnosis in the prognosis of patients with oral cancer. This study examined data on a previously reported cohort of 101 patients with oral squamous cell carcinoma diagnosed at a single institution between 2008 and 2010. The time interval between symptom onset and initial histological diagnosis (diagnostic delay) was recorded for each patient, as were demographic data and cancer features such as T stage, nodal status, and smoking status. The mean follow-up period was 4 years 10 months. The mean diagnostic delay was 4 months, mean overall survival was 5years 6 months, and mean disease-specific survival was 4 years 9 months. No significant correlation was found between diagnostic delay and overall survival, disease-specific survival, or recurrence rates. Patients with node-positive disease were more likely to be diagnosed earlier, whereas women and non-smokers were more likely to have a delayed diagnosis. Inherent tumour biology is likely an important prognostic factor separate to diagnostic delay. Public education efforts should focus on symptom recognition and encourage early presentation for investigation of oral lesions, particularly for females and non-smokers, so that more aggressive tumours can be treated sooner to give the best chance at survival.


Subject(s)
Carcinoma, Squamous Cell , Mouth Neoplasms , Carcinoma, Squamous Cell/diagnosis , Carcinoma, Squamous Cell/pathology , Cohort Studies , Delayed Diagnosis , Female , Humans , Mouth Neoplasms/diagnosis , Mouth Neoplasms/pathology , Neoplasm Recurrence, Local , Neoplasm Staging , Prognosis , Retrospective Studies
6.
Osteoporos Int ; 31(2): 267-275, 2020 Feb.
Article in English | MEDLINE | ID: mdl-31776636

ABSTRACT

Bone mineral density (BMD) is significantly decreased after gastrectomy in patients with gastric cancer. Calcium malabsorption, secondary hyperparathyroidism, and dominant bone resorption appear to contribute to bone loss in these patients. Patients should undergo early surveillance and nutritional or pharmacologic intensive interventions for bone health. PURPOSE: Survivorship care, including bone health, has become an important issue in gastric cancer. We performed a meta-analysis of the available observational studies to determine whether and how osteoporosis risk is increased after gastrectomy in patients with gastric cancer. METHODS: A total of 1204 patients (802 men) from 19 cohort studies were included. We evaluated the prevalence of osteoporosis in postgastrectomy patients, comparing the incidence according to the type of gastrectomy and sex. Additionally, we evaluated changes in bone mineral density (BMD) and bone metabolism-related markers pre- to postoperatively and between patients who underwent gastrectomy and matched controls. Proportion meta-analysis was performed and pooled odds ratios (ORs) were calculated. RESULTS: The pooled incidence estimate was 36% [95% confidence interval (CI), 32-40]. The incidence of osteoporosis was significantly higher in women than in men (OR = 1.90, p < 0.001) but was similar between partial and total gastrectomy groups (OR = 0.983, p = 0.939). BMD was significantly decreased, and calcium, phosphorous, and parathyroid hormone levels were significantly increased in patients after gastrectomy compared to those before gastrectomy. BMD and calcium and 25OH-vitamin D levels were significantly decreased, and parathyroid hormone and 1,25OH-vitamin D levels were significantly increased in the gastrectomy group compared to that in the control group. CONCLUSION: We found that BMD is significantly decreased after gastrectomy in patients with gastric cancer. Vitamin D deficiency and secondary hyperparathyroidism are suggested to be common mechanism underlying BMD impairment. After resection, patients should undergo long-term nutritional and bone health surveillance, in addition to their oncological follow-up.


Subject(s)
Bone Density , Gastrectomy , Osteoporosis , Stomach Neoplasms , Calcium , Female , Gastrectomy/adverse effects , Humans , Male , Osteoporosis/epidemiology , Osteoporosis/etiology , Parathyroid Hormone , Stomach Neoplasms/surgery , Vitamin D
7.
Bone Joint J ; 101-B(8): 897-901, 2019 08.
Article in English | MEDLINE | ID: mdl-31362553

ABSTRACT

Ceramic bearings have several desirable properties, such as resistance to wear, hardness, and biocompatibility, that favour it as an articulating surface in hip arthroplasty. However, ceramic fracture remains a concern. We have reviewed the contemporary literature, addressing the factors that can influence the incidence of ceramic bearing surface fracture. Cite this article: Bone Joint J 2019;101-B:897-901.


Subject(s)
Arthroplasty, Replacement, Hip/instrumentation , Ceramics , Hip Prosthesis , Prosthesis Design , Prosthesis Failure , Ceramics/adverse effects , Hip Prosthesis/adverse effects , Humans , Prosthesis Failure/adverse effects , Prosthesis Failure/etiology
8.
Oral Oncol ; 96: 113-120, 2019 09.
Article in English | MEDLINE | ID: mdl-31422202

ABSTRACT

INTRODUCTION: We have previously shown that oral swirls are a robust source of microRNA protected by extracellular vesicles, potentially useful to detect oral squamous cell carcinoma (OSCC)-associated molecular aberration. OBJECTIVES: To study a developed dysregulation score and risk classification algorithm based upon a panel of OSCC-associated microRNA in oral swirls from individuals with OSCC and oral potentially malignant disorders (OPMDs). MATERIALS AND METHODS: An OSCC-associated panel of 5 microRNAs (miR-24; miR-21; miR-99a; let-7c; miR-100;) was quantified by qPCR in 190 individuals with and without mucosal abnormalities, including OSCC (n = 53) and OPMDs (n = 74). Each sample was analyzed using a developed dysregulation score (dSCORE) and risk classification algorithm, allocating a LOW- or HIGH-RISK score. The influence of demographic, systemic, oral health and mucosal disease factors on the developed test was analyzed. RESULTS: MicroRNA for analysis can be predictably isolated from oral swirls sourced from individuals with a range of demographic, systemic and oral health findings. Utilizing the presence of HIGH-RISK identified OSCC patients with 86.8% sensitivity and 81.5% specificity. Older age and female gender were associated with higher dSCOREs and higher proportions of HIGH-RISK classification amongst individuals with no mucosal abnormalities. The dSCOREs for all subgroups of OPMDs were significantly different from the OSCC group. CONCLUSION: This is the first comparison of microRNA sourced from oral swirls from individuals with OPMDs with individuals with and without OSCC. A HIGH-RISK dysregulation signature was found to be accurate in indicating the presence of OSCC and exampled to parallel malignant transformation.


Subject(s)
Biomarkers, Tumor/metabolism , Carcinoma, Squamous Cell/genetics , MicroRNAs/genetics , Mouth Neoplasms/genetics , Carcinoma, Squamous Cell/pathology , Early Detection of Cancer , Female , Humans , Male , Middle Aged , Mouth Neoplasms/pathology
9.
Eur Cell Mater ; 38: 1-13, 2019 07 23.
Article in English | MEDLINE | ID: mdl-31332770

ABSTRACT

In the current study, a method is proposed to supply culture medium into a two-layered cell-laden tubular scaffold in order to enhance cell proliferation, confluence, and viability. The two-layered cell-laden tubular scaffold was made of calcium-alginate mixed with fibroblast cells (NIH/3T3) using a lab-made double- coaxial laminar-flow generator. Afterwards, the tubular scaffold was connected to a syringe pump system using a polydimethylsiloxane (PDMS) micro-connector for long-term cell culture. Three medium pumping conditions were applied and compared: a heart-beat-mimicking pumping (20 µL/s, 1 s period, and 50 % pulse width), a continuous pumping (20 µL/s) and a non-pumping. Non-leaky connections between the tubular scaffolds and the micro-connector outlet were sustained for 13.5 ± 0.83 d in heartbeat-mimicking pumping and 11.8 ± 0.33 d in continuous pumping condition, due to the elasticity of the tubular scaffolds. Importantly, the two pumping conditions resulted in more cell proliferation, confluence, and viability than the non-pumping condition. Furthermore, analysis of newly-produced type-I collagen matrix indicated that the cells under the two pumping conditions formed a tissue-like structure. The proposed technique could further be applied to vascular co-culturing for vascular engineered tissue.


Subject(s)
Cell Culture Techniques/methods , Infusion Pumps , Tissue Engineering/methods , Tissue Scaffolds/chemistry , 3T3 Cells , Alginates/chemistry , Animals , Cell Culture Techniques/instrumentation , Collagen/metabolism , Culture Media/chemistry , Dimethylpolysiloxanes/chemistry , Fibroblasts/cytology , Fibroblasts/metabolism , Fibroblasts/physiology , Mice , Tissue Engineering/instrumentation
10.
RSC Adv ; 9(61): 35878-35886, 2019 Oct 31.
Article in English | MEDLINE | ID: mdl-35528087

ABSTRACT

Monitoring the oil movement using a non-contact optical fiber probe during enhanced oil recovery is a novel technique to increase the efficiency of the process by distinguishing the oil position in the reservoir. A partially unclad fiber Bragg grating (FBG) coated with Fe3O4 nanoparticles as a magnetic field sensor is experimentally demonstrated. A series of six FBGs reflecting different wavelengths are fixed on the surface of sandstone. Nanofluids containing magnetite nanoparticles and alkaline-surfactant-polymer are injected continuously in two separate steps into the sandstone, which is saturated with 20% oil and 80% brine. The chamber is equipped with a solenoid that acts as a magnetic field generator. The changes in the magnetic field strength depended on the FBG-solenoid distance and the density of localized injected nanoparticles near the FBGs leads to a shift of the reflected wavelength of each single FBG accordingly. The shift is caused by the interference of different propagating modes reflected from the core-cladding and cladding-magnetite layer interfaces. The intensity of the FBG spectra decreases by injecting the nanofluid and vice versa for surfactant injection. The sensor response time of ∼21 s confirms the high reliability and repeatability of the sensing scheme. Movement of oil along the sandstone alters the wavelength shift in the FBG spectra.

11.
Foot Ankle Surg ; 25(4): 523-528, 2019 Aug.
Article in English | MEDLINE | ID: mdl-30321952

ABSTRACT

BACKGROUND: Modern designs of total ankle arthroplasty (TAA) have the potential to treat symptomatic ankle OA without adversely affecting ankle biomechanics. We present the mid-term results of a modern, mobile-bearing TAA design. METHODS: TAA was performed in 50 consecutive patients (55 ankles) in an independent, prospective, single-centre series. Implant survival, patient-reported outcome measures (PROMs) and radiographic outcomes are presented at a mean of five years (range 2-10.5years). RESULTS: A total of three patients (four ankles) died and two (two ankles) were lost to follow-up. Three TAAs were revised for aseptic loosening (in two cases) or infection. Two further patients underwent reoperations, one for arthroscopic debridement of anterolateral synovitis and one for grafting of an asymptomatic tibial cyst. With all-cause revision as an endpoint, implant survival was 93.3% at five to ten years (95% CI 80.5%-97.8%). If reoperations are included this falls to 90.2% (95% CI 75.6%-96.3%) at five years. No other patient demonstrated radiographic evidence of loosening or subsidence. PROMs and satisfaction were excellent at latest follow-up. CONCLUSION: At five years, the outcomes for this design of TAA in this series were excellent, and were similar to those of previously published series from the designer centre.


Subject(s)
Arthritis, Rheumatoid/surgery , Arthroplasty, Replacement, Ankle , Joint Prosthesis , Osteoarthritis/surgery , Aged , Aged, 80 and over , Arthritis, Rheumatoid/diagnostic imaging , Arthritis, Rheumatoid/physiopathology , Female , Follow-Up Studies , Humans , Male , Middle Aged , Osteoarthritis/diagnostic imaging , Osteoarthritis/physiopathology , Patient Reported Outcome Measures , Prospective Studies , Prosthesis Design , Prosthesis Failure , Radiography , Reoperation , Time Factors , Treatment Outcome
12.
Orthop Traumatol Surg Res ; 104(3): 341-346, 2018 05.
Article in English | MEDLINE | ID: mdl-29458202

ABSTRACT

BACKGROUND: Intra-operative estimation of stem anteversion in total hip arthroplasty (THA) using postero-lateral approach is made by the surgeon's visual assessment, using the tibia as a guide, with the assumption that tibial axis is vertical to the trans-epicondylar axis. However, the accuracy of the intra-operative estimation has rarely been verified with postoperative CT-scans, with controversies regarding these measurements particularly in case of knee osteoarthritis. Therefore we performed a prospective study to: (1) determine the accuracy of the intra-operative measurement and (2) investigate factors affecting the discrepancy between the surgeon's estimation and the real stem anteversion. HYPOTHESIS: Intra-operative estimation of stem anteversion correlated with the real stem anteversion on CT-scan. PATIENTS AND METHODS: Sixty-seven THAs using cementless straight stems (65 patients) without ipsilateral total knee arthroplasty were prospectively evaluated to compare the intra-operative measurement of stem anteversion with the real stem anteversion on computed tomography (CT) scans. There were 33 men and 34 women with a mean age of 59.7years (range, 27-84years) at the time of surgery. Age, tibia plateau angle, native femoral anteversion, femoro-tibial angle, body mass index, operative site, gender, coronal and sagittal tilt of the stem, stem type, ipsilateral knee osteoarthritis, and preoperative diagnosis were analyzed to evaluate the factors affecting the discrepancy between the intra-operative and CT measurements. RESULTS: The intra-operative estimation (mean, 21.5°±8.5°; range, 5.0°-39.0°) was greater than the CT measurement (mean, 19.5°±8.7°; range, 4.5°-38.5°) by 2.0°. The mean absolute value of discrepancy was 4.5°. The correlation coefficient between intra-operative and CT measurements was 0.837. The femoro-tibial angle was associated with the discrepancy between the two measurements. In the presence of genu varum deformity, the intra-operative measurement underestimated the stem anteversion. DISCUSSION: Although intra-operative estimation of stem anteversion was slightly greater than the real stem anteversion, there was an excellent correlation between the two. The femoro-tibial angle should be considered to optimize the stem anteversion during cementless THA using postero-lateral approach. LEVEL OF EVIDENCE: Level III, prospective case control study.


Subject(s)
Arthroplasty, Replacement, Hip/methods , Hip Joint/diagnostic imaging , Tomography, X-Ray Computed , Adult , Aged , Aged, 80 and over , Bone Conduction , Case-Control Studies , Female , Femur/diagnostic imaging , Hip Prosthesis , Humans , Intraoperative Period , Male , Middle Aged , Postoperative Period , Prospective Studies , Tibia/diagnostic imaging
13.
BMC Med Res Methodol ; 17(1): 106, 2017 Jul 17.
Article in English | MEDLINE | ID: mdl-28716047

ABSTRACT

BACKGROUND: The standard definition for protocol adherence is the proportion of all scheduled doses that are delivered. In clinical research, this definition has several limitations when evaluating protocol adherence in trials that study interventions requiring continuous titration. DISCUSSION: Building upon a specific case study, we analyzed a recent trial of a continuously titrated intervention to assess the impact of different definitions of protocol deviations on the interpretation of protocol adherence. The OVATION pilot trial was an open-label randomized controlled trial of higher (75-80 mmHg) versus lower (60-65 mmHg) mean arterial pressure (MAP) targets for vasopressor therapy in shock. In this trial, potential protocol deviations were defined as MAP values outside the targeted range for >4 consecutive hours during vasopressor therapy without synchronous and consistent adjustments of vasopressor doses. An adjudication committee reviewed each potential deviation to determine if it was clinically-justified or not. There are four reasons for this contextual measurement and reporting of protocol adherence. First, between-arm separation is a robust measure of adherence to complex protocols. Second, adherence assessed by protocol deviations varies in function of the definition of deviations and the frequency of measurements. Third, distinguishing clinically-justified vs. not clinically-justified protocol deviations acknowledges clinically sensible bedside decision-making and offers a clear terminology before the trial begins. Finally, multiple metrics exist to report protocol deviations, which provides different information but complementary information on protocol adherence. CONCLUSIONS: In trials of interventions requiring continuous titration, metrics used for defining protocol deviations have a considerable impact on the interpretation of protocol adherence. Definitions for protocol deviations should be prespecified and correlated with between-arm separation, if it can be measured.


Subject(s)
Clinical Protocols , Patient Compliance , Randomized Controlled Trials as Topic/standards , Research Design/standards , Arterial Pressure/drug effects , Humans , Hypotension/drug therapy , Hypotension/etiology , Pilot Projects , Randomized Controlled Trials as Topic/methods , Shock/complications , Vasoconstrictor Agents/therapeutic use
14.
Osteoporos Int ; 28(10): 2853-2858, 2017 10.
Article in English | MEDLINE | ID: mdl-28612307

ABSTRACT

In Korean, atypical subtrochanteric fractures (ASF) were rare. Higher BMI and use of bisphosphonate were significant risk factors of ASF. INTRODUCTION: Recently, ASF have been reported to increase among patients on bisphosphonate. However, the incidence of ASF and the association between ASF and bisphosphonate use have not been well defined in Asian population. Our purposes are (1) to estimate the proportion of ASF among Korean patients with proximal femur fracture and (2) to determine the associated risk factors of ASF in the Korean patients. METHODS: We conducted a multicenter (16 academic hospitals), prospective Korean hip fracture study on hip fracture in a cohort of patients aged 50 years or older from South Korea between July 2014 and May 2016. As a part of Korean hip fracture study, primary analysis examined the proportion of ASF among proximal femur fracture. To identify ASF, according to the definition by ASBMR task force, all radiographs of subtrochanteric fracture were reviewed. Associated risk factors for occurrence of ASF were also evaluated by using multivariable logistic regression analysis. RESULTS: Among 1361 patients with proximal femoral fractures due to low-energy trauma, 17 fractures (1.2%) were identified as ASF. Higher BMI and use of bisphosphonate before injury were independent risk factors of ASF. CONCLUSION: In Korean, ASF were rare. Higher BMI and use of bisphosphonate were significant risk factors of ASF.


Subject(s)
Bone Density Conservation Agents/adverse effects , Diphosphonates/adverse effects , Fractures, Spontaneous/chemically induced , Hip Fractures/chemically induced , Absorptiometry, Photon , Aged , Aged, 80 and over , Body Mass Index , Drug Utilization/statistics & numerical data , Female , Fractures, Spontaneous/epidemiology , Hip Fractures/epidemiology , Humans , Incidence , Male , Middle Aged , Prospective Studies , Republic of Korea/epidemiology , Risk Factors
15.
Bone Joint J ; 99-B(6): 741-748, 2017 Jun.
Article in English | MEDLINE | ID: mdl-28566392

ABSTRACT

AIMS: We conducted a prospective study of a delta ceramic total hip arthroplasty (THA) to determine the rate of ceramic fracture, to characterise post-operative noise, and to evaluate the mid-term results and survivorship. PATIENTS AND METHODS: Between March 2009 and March 2011, 274 patients (310 hips) underwent cementless THA using a delta ceramic femoral head and liner. At each follow-up, clinical and radiological outcomes were recorded. A Kaplan-Meier analysis was undertaken to estimate survival. RESULTS: Four patients (four hips) died and 18 patients (20 hips) were lost to follow-up within five years. The remaining 252 patients (286 hips) were followed for a mean of 66.5 months (60 to 84). There were 144 men (166 hips) and 108 women (120 hips) with a mean age of 49.7 years (16 to 83) at surgery. The mean pre-operative Harris Hip Score of 47.1 points improved to 93.8 points at final follow-up. Six patients reported squeaking in seven hips; however, none were audible. Radiolucent lines involving Gruen zones one and/or seven were seen in 52 hips (18.2%). No hip had detectable wear, focal osteolysis or signs of loosening. One hip was revised because of fracture of the ceramic liner, which occurred due to an undetected malseating of the ceramic liner at the time of surgery. One hip was revised for a periprosthetic fracture of the femur, and one hip was treated for periprosthetic joint infection. The six-year survivorship with re-operation for any reason as the endpoint was 99.0% (95% confidence interval 97.8% to 100%). DISCUSSION: The rate of delta ceramic fracture was 0.3% (one of 286). While ceramic head fracture was dominant in previous ceramic-on-ceramic THA, fracture of the delta ceramic liner due to malseating is a concern. Cite this article: Bone Joint J 2017;99-B:741-8.


Subject(s)
Arthroplasty, Replacement, Hip/instrumentation , Ceramics , Hip Prosthesis , Adolescent , Adult , Aged , Aged, 80 and over , Arthroplasty, Replacement, Hip/adverse effects , Arthroplasty, Replacement, Hip/methods , Ceramics/adverse effects , Female , Femur Head Necrosis/diagnostic imaging , Femur Head Necrosis/surgery , Hip Joint/diagnostic imaging , Hip Prosthesis/adverse effects , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Noise , Prospective Studies , Prosthesis Design , Prosthesis Failure/etiology , Radiography , Reoperation , Treatment Outcome , Young Adult
16.
Bone Joint J ; 99-B(4): 440-444, 2017 Apr.
Article in English | MEDLINE | ID: mdl-28385931

ABSTRACT

AIMS: Modular or custom-made femoral components have been preferred for total hip arthroplasty (THA) in patients with a history of Perthes' disease because of the distortion in the anatomy of the proximal femur. However, it has not been established whether a monobloc cementless stem will fit the distorted proximal femur or whether the results of the procedure are satisfactory in this group of patients. PATIENTS AND METHODS: We reviewed 68 consecutive patients who had undergone THA for childhood Perthes' disease between June 2003 and December 2008. There were 35 men and 33 women with a mean age of 48 years (16 to 73) at the time of index arthroplasty. Their mean body mass index was 24.4 (18.3 to 32.9). Of the 68 hips, 32 were classified as Stulberg class III and 36 as class IV. The mean pre-operative shortening of the affected leg was 17.2 mm (5 to 34). The minimum follow-up was five years (mean 8.5 years; 5.2 to 10). RESULTS: An intra-operative calcar fracture occurred in eight hips (11.8%) and was successfully treated by cerclage wiring. The mean stem version was 14.6° (-2.3 to 30; standard deviation (sd) 7.3). The mean acetabular component abduction was 40.2° (23.7 to 56.0; sd 6.5) and the mean anteversion 28.3° (6.4 to 43.0; sd 7.6), respectively. The mean follow-up was 8.5 years (5.2 to 10). No dislocations occurred and no hips were revised during the course of the study. At final follow-up, the mean Harris Hip Score was 91 points (59 to 100) and the mean University of California, Los Angeles activity score was 3.2 (2 to 8). CONCLUSION: Monobloc cementless stems reliably restore the anatomy in Perthes' disease at THA without the need for custom-made or modular implants. Cite this article: Bone Joint J 2017;99-B:440-444.


Subject(s)
Arthroplasty, Replacement, Hip/methods , Hip Prosthesis , Legg-Calve-Perthes Disease/surgery , Osteoarthritis, Hip/surgery , Adolescent , Adult , Aged , Cementation , Female , Femur/surgery , Hip Joint/diagnostic imaging , Humans , Legg-Calve-Perthes Disease/complications , Legg-Calve-Perthes Disease/diagnostic imaging , Male , Middle Aged , Osteoarthritis, Hip/diagnostic imaging , Osteoarthritis, Hip/etiology , Prosthesis Design , Radiography , Retrospective Studies , Treatment Outcome , Young Adult
18.
Anaesthesia ; 71(1): 67-75, 2016 Jan.
Article in English | MEDLINE | ID: mdl-26559015

ABSTRACT

We evaluated changes in rotational thromboelastometry (ROTEM(®) ) parameters and clinical outcomes in patients undergoing total hip replacement arthroplasty, with concomitant infusions of tranexamic acid and of 6% hydroxyethyl starch 130/0.4. Fifty-five patients were randomly assigned to either the tranexamic acid (n = 29) or the control (n = 26) group. Hydroxyethyl starch was administered in the range of 10-15 ml.kg(-1) during the operation in both groups. In the control group, the clot formation time and maximum clot firmness of APTEM showed significant differences when compared with those of EXTEM at one hour postoperatively, suggestive of fibrinolysis. In the tranexamic acid group, there was no significant difference between each postoperative EXTEM and APTEM parameter. In the tranexamic acid and control group, postoperative blood loss was 308 ml (210-420 [106-745]) and 488 ml (375-620 [170-910], p = 0.002), respectively, and total blood loss was 1168 ml (922-1470 [663-2107]) and 1563 ml (1276-1708 [887-1494], p = 0.003). Haemoglobin concentration was higher in the tranexamic acid group on the second postoperative day (10.5 (9.4-12.1 [7.9-14.0]) vs. 9.6 (8.9-10.5[7.3-16.0]) g.dl(-1) , p = 0.027). In patients undergoing total hip replacement arthroplasty, postoperative fibrinolysis aggravated by hydroxyethyl starch was attenuated by co-administration of 10 mg.kg(-1) tranexamic acid, which may have led to less postoperative blood loss.


Subject(s)
Antifibrinolytic Agents/pharmacology , Arthroplasty, Replacement, Hip , Blood Coagulation/drug effects , Thrombelastography/methods , Tranexamic Acid/pharmacology , Adult , Aged , Aged, 80 and over , Blood Loss, Surgical/prevention & control , Female , Humans , Male , Middle Aged , Tranexamic Acid/adverse effects
19.
J Dent Res ; 94(7): 921-7, 2015 Jul.
Article in English | MEDLINE | ID: mdl-25904141

ABSTRACT

Subgingival microorganisms are potentially associated with periodontal diseases. However, changes in the subgingival microbiota during the progress of periodontal diseases are poorly understood. In this study, we analyzed bacterial communities in the subgingival paper point samples from 32 Korean individuals with no sign of disease, gingivitis, or periodontitis using 454 FLX Titanium pyrosequencing. A total of 256,113 reads representing 26 phyla, 433 genera, and 1,016 species were detected. Bacteroidetes, Fusobacteria, Synergistetes, and Spirochaetes were the abundant phyla in periodontitis subjects, whereas Firmicutes and Proteobacteria were identified as the dominant phyla in the gingivitis and healthy subjects, respectively. Although high levels of Porphyromonas, Fusobacterium, Fretibacterium, Rothia, Filifactor, and Treponema genera were observed in the periodontitis subjects, Streptococcus, Capnocytophaga, Leptotrichia, and Haemophilus genera were found at high frequency in the gingivitis subjects. Species including Porphyromonas gingivalis, Fusobacterium nucleatum, and Fretibacterium fastidiosum were significantly increased in periodontitis subjects. On the other hand, Streptococcus pseudopneumoniae, Haemophilus parainfluenzae, and Leptotrichia hongkongensis were preferentially observed in the gingivitis subjects. Intriguingly, the halophile Halomonas hamiltonii was revealed as a predominant species in the healthy subjects. Based on Fast UniFrac analysis, distinctive bacterial clusters were classified for the healthy, gingivitis, and periodontitis state. The current findings might be useful for understanding the pathogenesis, diagnosis, and treatment of periodontal diseases.


Subject(s)
Bacteria/classification , Gingivitis/microbiology , Periodontitis/microbiology , Periodontium/microbiology , Actinomycetaceae/classification , Adolescent , Adult , Aged , Aged, 80 and over , Bacteroidetes/isolation & purification , Capnocytophaga/isolation & purification , Fusobacteria/isolation & purification , Fusobacterium/classification , Fusobacterium nucleatum/isolation & purification , Gram-Negative Anaerobic Straight, Curved, and Helical Rods/classification , Gram-Negative Bacteria/classification , Haemophilus/classification , Haemophilus parainfluenzae/isolation & purification , Halomonas/isolation & purification , Humans , Leptotrichia/isolation & purification , Middle Aged , Porphyromonas/classification , Porphyromonas gingivalis/isolation & purification , Proteobacteria/isolation & purification , Sequence Analysis, DNA , Spirochaetales/isolation & purification , Streptococcus/classification , Treponema/isolation & purification , Young Adult
20.
J Laryngol Otol ; 129 Suppl 1: S27-31, 2015 Jan.
Article in English | MEDLINE | ID: mdl-25656280

ABSTRACT

BACKGROUND: Panendoscopy is routinely used for the identification of occult second primary tumours in head and neck squamous cell carcinoma. However, its role in low risk subgroups, particularly non-smoking, non-drinking patients and patients presenting with early stage oral cavity lesions, is debatable. METHODS: The records of 112 patients with T1 or T2 oral tongue squamous cell carcinoma were retrospectively reviewed. Demographic, disease characteristics and survival data were collected. RESULTS: Average follow-up duration was 71.7 months (range, 3.6-238.3 months). Thirty-five patients died within this period. Thirteen second primary events were identified in 11 patients, with all but 2 tumours in the oral cavity or oropharynx. There was a single synchronous primary - a lung adenocarcinoma; all other events were metachronous. No non-smoking, non-drinking patients re-presented with a second primary tumour; tobacco and alcohol use are clearly risk factors for development of a second primary tumour. CONCLUSION: The role of panendoscopy for identifying synchronous primary tumours in patients with early stage oral tongue squamous cell carcinoma should be re-evaluated, particularly in non-smoking, non-drinking patients who are at low risk of second primary development. Close follow up with regular clinical examination including flexible fibre-optic endoscopy may be sufficient in this subgroup.


Subject(s)
Carcinoma, Squamous Cell/diagnosis , Endoscopy/methods , Head and Neck Neoplasms/diagnosis , Mouth Neoplasms/diagnosis , Neoplasms, Second Primary/diagnosis , Tongue Neoplasms/diagnosis , Aged , Alcohol Drinking/pathology , Carcinoma, Squamous Cell/pathology , Female , Head and Neck Neoplasms/pathology , Humans , Incidence , Male , Middle Aged , Mouth Neoplasms/pathology , Neoplasm Invasiveness , Neoplasm Staging , Neoplasms, Second Primary/pathology , Prevalence , Retrospective Studies , Smoking/pathology , Squamous Cell Carcinoma of Head and Neck , Tongue Neoplasms/pathology
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