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1.
Hip Int ; 34(5): 614-621, 2024 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-38556811

RESUMO

BACKGROUND: Recently, surgeons introduced a minimally invasive modification on the classic posterolateral approach (PLA) in total hip arthroplasty (THA): the direct superior approach (DSA). We investigated the association between surgeon's experience and the risk of early revision of the DSA in primary THA, using data from the Dutch Arthroplasty Register (LROI). METHODS: We retrieved all primary THAs performed using the DSA in 4 hospitals between 2016 and 2022 (n = 1551). Procedures were sorted in 5 groups using the date of operation and number of previous procedures per surgeon: 1-25; 26-50; 51-75; 76-100; >100. Subsequently, data from different surgeons were pooled together and the risk of revision was calculated via a multilevel time-to-event analysis. RESULTS: The overall revision rate was 1.5% after a mean follow-up of 2 years. Patients from the 1-25 group had comparable risks of revision compared to patients in the >100 group (hazard ratio [HR] 1.0 [CI, 0.3-3.2]). The risk for patients in groups 26-50, 51-75 and 75-100 was also not statistically different from the >100 group (resp. HR 1.5 [CI, 0.5-5.0], 1.8 [CI, 0.5-6.4] and 0.5 [CI, 0.1-4.0]). Main reasons of revision were dislocation (0.5%) and infection (0.4%). CONCLUSIONS: We did not identify an association between the surgeon's experience and the early risk of revision for the DSA in primary THA in the Netherlands. The DSA seems safe in the early adoption phases with a low risk of revision due to dislocation and revision for all other causes.


Assuntos
Artroplastia de Quadril , Falha de Prótese , Sistema de Registros , Reoperação , Humanos , Artroplastia de Quadril/métodos , Reoperação/estatística & dados numéricos , Países Baixos , Feminino , Masculino , Pessoa de Meia-Idade , Idoso , Estudos Retrospectivos
2.
Obes Surg ; 34(4): 1113-1121, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38400947

RESUMO

PURPOSE: Feedback on technical and procedural skills is essential during the training of residents and fellows. The aim of this study was to assess the performance of a newly created instrument for the assessment of operative skills using laparoscopic Roux-en-Y gastric bypass (LRYGB) video fragments. MATERIALS AND METHODS: A new procedure-based assessment (PBA) was created by combining LRYGB key steps with a 5-point independence scale. LRYGB performed by residents and surgeons with different levels of expertise were video recorded. Fragments of the pouch creation, gastro-jejunostomy and jejunojejunostomy, were review by 12 expert bariatric surgeons and the operative skills assessed with the PBA, Objective Structured Assessment of Technical Skill (OSATS), and the Bariatric OSATS (BOSATS). The PBA was compared to the OSATS and BOSATS. Mean scores for all items of the different assessments were summarized and compared using a T-test. RESULTS: The scores of the procedural steps were combined and compared for all levels. The mean scores for beginner, intermediate, and expert level were 2.71, 3.70, and 3.90 for the PBA; for the OSATS 1.84, 2.86, and 3.44; and for the BOSATS 2.78, 3.56, and 4.19. Each of these assessments differentiated between the three skill levels (all p < 0.05). CONCLUSION: The PBA discriminates well between different levels of operative skills. Similar patterns were found for the OSATS and BOSATS, showing that the randomly selected video fragments are representative samples for assessing skill level. Future research will demonstrate whether these results can be extrapolated to clinical training, and which scores allow for procedure certification.


Assuntos
Derivação Gástrica , Internato e Residência , Laparoscopia , Obesidade Mórbida , Cirurgiões , Humanos , Derivação Gástrica/educação , Obesidade Mórbida/cirurgia , Laparoscopia/educação , Competência Clínica
3.
Int J Colorectal Dis ; 38(1): 105, 2023 Apr 19.
Artigo em Inglês | MEDLINE | ID: mdl-37074421

RESUMO

BACKGROUND: Laparoscopic surgery has become the golden standard for many procedures, requiring new skills and training methods. The aim of this review is to appraise literature on assessment methods for laparoscopic colorectal procedures and quantify these methods for implementation in surgical training. MATERIALS AND METHODS: PubMed, Embase and Cochrane Central Register of Controlled Trials databases were searched in October 2022 for studies reporting learning and assessment methods for laparoscopic colorectal surgery. Quality was scored using the Downs and Black checklist. Included articles were categorized in procedure-based assessment methods and non-procedure-based assessment methods. A second distinction was made between capability for formative and/or summative assessment. RESULTS: In this systematic review, nineteen studies were included. These studies showed large heterogeneity despite categorization. Median quality score was 15 (range 0-26). Fourteen studies were categorized as procedure-based assessment methods (PBA), and five as non-procedure-based assessment methods. Three studies were applicable for summative assessment. CONCLUSIONS: The results show a considerable diversity in assessment methods with varying quality and suitability. To prevent a sprawl of assessment methods, we argue for selection and development of available high-quality assessment methods. A procedure-based structure combined with an objective assessment scale and possibility for summative assessment should be cornerstones.


Assuntos
Cirurgia Colorretal , Procedimentos Cirúrgicos do Sistema Digestório , Laparoscopia , Humanos , Cirurgia Colorretal/métodos , Laparoscopia/métodos
4.
Support Care Cancer ; 31(2): 138, 2023 Jan 26.
Artigo em Inglês | MEDLINE | ID: mdl-36701038

RESUMO

PURPOSE: Peripheral neuropathy (PN) is common in multiple myeloma (MM) patients. More insight has been gained concerning the role of vitamin D in preventing PN. However, studies evaluating the effects of vitamin D3 supplementation on PN are lacking. The aims of this study are to (1) evaluate the effectiveness of a vitamin D3 regimen on achieving adequate vitamin D levels in deficient MM patients and to (2) exploratively evaluate the effect of vitamin D3 supplementation on PN. METHODS: Thirty-nine MM patients with inadequate (< 75 nmol/L [= 30 ng/mL]) 25-hydroxyvitamin D (25(OH)D) levels were included in this multicenter, prospective, single-arm study, of whom 35 patients completed the study. They received oral vitamin D3 for 6 months according to a dose escalation regimen that consisted of one or two loading doses of 200,000 international units (IU), and maintenance doses of 800, 1600, or 3200 IU/day depending on the 25(OH)D level. A validated questionnaire was used to measure PN. RESULTS: Median 25(OH)D increased from 38 (IQR 32-52) nmol/L at baseline to 77 (IQR 72-87) nmol/L after 6 months (P < 0.001). Adequate 25(OH)D levels were achieved by 66% of the subjects, and 34% were within the range of 50-75 nmol/L. Furthermore, in 37% of the participants, PN severity decreased (P = 0.007). CONCLUSION: The use of substantially higher vitamin D3 doses than recommended in current guidelines resulted in a significant increase in vitamin D levels in MM patients. Furthermore, evaluation of PN showed a significant decrease in PN grading. However, this exploratory evaluation needs further confirmatory research.


Assuntos
Mieloma Múltiplo , Doenças do Sistema Nervoso Periférico , Deficiência de Vitamina D , Humanos , Estudos Prospectivos , Mieloma Múltiplo/complicações , Mieloma Múltiplo/tratamento farmacológico , Suplementos Nutricionais , Deficiência de Vitamina D/tratamento farmacológico , Vitamina D/uso terapêutico , Vitaminas , Colecalciferol/uso terapêutico , Colecalciferol/farmacologia , Doenças do Sistema Nervoso Periférico/tratamento farmacológico , Doenças do Sistema Nervoso Periférico/etiologia
5.
J Geriatr Oncol ; 14(2): 101418, 2023 03.
Artigo em Inglês | MEDLINE | ID: mdl-36657246

RESUMO

INTRODUCTION: Treatment for myelodysplastic syndromes (MDS) is complex, options are limited, and insight into consecutive treatments is lacking. We performed this study to assess the outcomes in a real-world cohort of patients with MDS. MATERIALS AND METHODS: An observational population-based study was performed using the HemoBase registry. Treatment patterns and overall survival (OS) were analyzed with Kaplan-Meier analyses. RESULTS: In 144 of 280 (51.4%) patients with MDS >50 years, first-line treatment was initiated. The median age was 75.1 years (range: 52.6-92.0); the majority were male (72.2%). Hypomethylating agents (HMA), intensive chemotherapy, lenalidomide, and erythropoiesis-stimulating agents (ESA) were given as first-line treatment to 31.1% (n = 45), 12.5% (n = 18), 2.8% (n = 4), and 53.5% (n = 77) of the population, respectively. The median treatment duration was 5.8 months (95% Confidence Interval [CI]: 1.1-10.4) for HMA, 1.7 months (95%CI: 0.9-2.6) for intensive chemotherapy, 10.8 months (95%CI: 4.7-17.0) for lenalidomide, and 14.8 months (95%CI: 11.4-18.1) for ESA. Consecutive treatments were given to 27.2% of patients. The main reasons for first-line treatment discontinuation were treatment failure (45.8%), toxicity (6.9%), or death (20.1%). Median OS after termination of the initial, second, and third treatment was 5.8 months (95%CI: 3.2-8.5), 9.3 months (95%CI: 0.0-19.6), and 1.0 months (95%CI: 0.0-5.1), respectively. DISCUSSION: This study shows the treatment outcomes in a real-world population of older patients with MDS. Treatment duration and median OS after treatment discontinuation were relatively limited. There is still an urgent need for new treatment options, strategies to further optimize duration of existing treatments, and communication of realistic treatment goals and expectations, especially for older, higher-risk patients with MDS with a poor prognosis.


Assuntos
Síndromes Mielodisplásicas , Humanos , Masculino , Feminino , Idoso , Lenalidomida , Síndromes Mielodisplásicas/terapia , Resultado do Tratamento , Falha de Tratamento , Estimativa de Kaplan-Meier
6.
EJHaem ; 3(3): 775-784, 2022 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-36051088

RESUMO

The a priori risk for infections in patients with myelodysplastic syndromes (MDS) is unknown. This study examines prescription rates of anti-infective agents in MDS patients before and after diagnosis, in both in- and outpatient settings, to provide information on infection management in clinical practice. We performed a population-based study using the HemoBase registry, containing data of all MDS patients diagnosed since 2005 in Friesland, the Netherlands. Community and hospital pharmacies provided prescription data from 1995 to 2020. Data were obtained for 203 of 292 patients (70%). Patients received significantly more anti-infective agents, predominantly antibacterials (70%), after diagnosis compared to before: 148.7 defined daily dose/1000 days (DID) (95% CI: 146.9-150.5) and 55.1 DID (95% CI: 54.5-55.8, p < 0.01), respectively, corresponding to median 23.5 and 7.6 treatment days/year. Higher-risk (449.9 DID) and lower-risk patients (129.1 DID) both received significantly more anti-infective agents after diagnosis; comorbidities, neutropenia, and age did not show significant differences relative to prescription rates. Before diagnosis, 10% of patients had infection-related hospital admissions versus 38% after diagnosis. In conclusion, MDS patients received significantly more anti-infective agents compared to before diagnosis. This is the first study that has quantified the prescription rate of anti-infective agents within and beyond the clinical setting in MDS.

7.
Eur J Haematol ; 109(6): 772-778, 2022 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-36130872

RESUMO

OBJECTIVES: In patients with myelodysplastic syndromes (MDS) with >20 transfusions and ferritin levels >1000 µg/L, international guidelines recommend iron chelation therapy (ICT). The study's objective was to determine guideline adherence and the intensity of ferritin monitoring in clinical practice. METHODS: We performed an observational population-based study using the HemoBase Registry, which contains data of all MDS patients diagnosed since 2005 in Friesland, the Netherlands. Clinical information on transfusions, ferritin measurements, ICT, and clinical performance as defined by age ≤ 80 years, Charlson Comorbidity Index <2 and lower-risk MDS was collected from health records. RESULTS: Two hundred and thirty seven of 292 patients (81.1%) received ≥1 transfusion, and 121 (41.4%) received >20 transfusions. In 57 of these 121 patients (47.1%), ferritin measurements were performed at least once. Clinical performance was significantly associated with monitoring ferritin around the 20th transfusion (RR: 2.49, p = .016). Clinical performance was also associated with initiating ICT (RR: 5.99, p < .001). ICT was offered to 22.3% (n = 25) of eligible patients. CONCLUSIONS: In this population-based study, ferritin levels were measured in <50% of MDS patients who received >20 transfusions, and clinical performance was significantly associated with measuring ferritin. Our study suggests that in heavily transfused MDS patients, ferritin monitoring is primarily based on patients' clinical performance rather than guideline recommendations.


Assuntos
Sobrecarga de Ferro , Síndromes Mielodisplásicas , Idoso de 80 Anos ou mais , Humanos , Terapia por Quelação , Ferritinas , Fidelidade a Diretrizes , Ferro , Quelantes de Ferro/uso terapêutico , Sobrecarga de Ferro/diagnóstico , Sobrecarga de Ferro/tratamento farmacológico , Sobrecarga de Ferro/etiologia , Síndromes Mielodisplásicas/diagnóstico , Síndromes Mielodisplásicas/tratamento farmacológico
8.
Eur J Haematol ; 109(4): 381-387, 2022 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-35753043

RESUMO

OBJECTIVES: Infections are a major cause of morbidity and mortality in patients with myelodysplastic syndromes (MDS). The objective of the MINDSET study was to evaluate haematologists' management of infection prevention in MDS patients using a case vignette study and to assess the availability of guidelines. METHODS: We conducted a web-based, nationwide survey amongst haematologists in the Netherlands between September and December 2021. The survey included a set of case vignettes. In addition, the availability of protocols was evaluated. RESULTS: Sixty responses were obtained (23.6%). These responses were well distributed across hospital types as well as level of experience. No protocols regarding infection prophylaxis specifically for MDS patients were received. In the case vignette of a 75-year-old MDS patient, respondents would primarily prescribe infection prophylaxis in case of recurrent infections (96.7%) and neutropenia (75.0% for absolute neutrophil count [ANC] < 0.2 × 109 /L and 53.3% for ANC < 0.5 × 109 /L), especially in combination with hypomethylating agents (80.0%), lenalidomide (66.7%) or chemotherapy (51.7%). Respondents would predominantly choose antibacterial agents (85.0%), followed by antifungal agents (71.7%). CONCLUSIONS: This study showed diverse reasons and considerations of haematologists regarding whether to prescribe infection prophylaxis in MDS patients. Given the seriousness of infections in MDS patients, patient-tailored recommendations might be valuable in clinical decision-making.


Assuntos
Síndromes Mielodisplásicas , Idoso , Antifúngicos/uso terapêutico , Humanos , Internet , Lenalidomida/uso terapêutico , Síndromes Mielodisplásicas/tratamento farmacológico , Síndromes Mielodisplásicas/terapia , Inquéritos e Questionários
9.
Blood Transfus ; 20(1): 18-26, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-33370223

RESUMO

BACKGROUND: Alloimmunisation against blood products is an adverse event, causing time-consuming compatibility testing. Current literature has not yet identified the influence of treatment on the risk of alloimmunisation in patients with myelodysplastic syndromes (MDS). MATERIALS AND METHODS: An observational, population-based study, using the HemoBase registry, was performed including all transfused patients who were diagnosed with MDS between 2005 and 2017 in Friesland, a province in the Netherlands. Information about transfusion dates, types, and treatment regimens was collected from the health records. Blood products were matched for ABO and Rhesus D. The effect of disease-modifying treatment was estimated with incidence rates and a Cox time-dependent analysis. RESULTS: 233 patients were included in this study, with a median follow-up of 13.0 months. Alloimmunisation occurred in 21 patients (9.0%) and predominantly occurred early in follow-up. Three (5%) and 18 (11%) alloimmunisation events occurred in patients with and without disease-modifying treatment, respectively. The hazard ratio for alloimmunisation without treatment compared to during treatment was 2.7 (95% CI: 0.35-20.0), with incidence rates of 7.18 and 2.41 per 100 patient-years, respectively. DISCUSSION: In a non-selected real-world population of MDS patients receiving blood transfusions, the percentage of patients with alloimmunisation was below 10%. The results of this study support the hypothesis that disease-modifying treatment affects the ability of the immune system to mount an antibody response to non-self blood group antigens.


Assuntos
Anemia Hemolítica Autoimune , Antígenos de Grupos Sanguíneos , Síndromes Mielodisplásicas , Transfusão de Sangue , Humanos , Incidência , Síndromes Mielodisplásicas/epidemiologia , Síndromes Mielodisplásicas/terapia
10.
Obes Surg ; 32(3): 742-748, 2022 03.
Artigo em Inglês | MEDLINE | ID: mdl-34855136

RESUMO

BACKGROUND: The aim of this study was to evaluate the effect of bariatric surgery on the defined daily dose of levothyroxine (DDD LT4), thyroid-stimulating hormone (TSH), and free thyroxine (fT4) in female patients with hypothyroidism until 48 months after surgery. METHODS: A retrospective observational study of hypothyroid patients who underwent bariatric surgery. Changes in DDD LT4, TSH, and fT4 over a 48 month period after surgery were analyzed. RESULTS: Thirty-seven patients were included: 27 Roux-en-Y gastric bypass (RYGB), 6 sleeve gastrectomy (SG), 3 adjustable gastric band, and 1 one anastomosis gastric bypass. The median DDD LT4 decreased from 125 µg at baseline to 100 µg 12 months after surgery. From 24 to 48 months after surgery, the median DDD LT4 was stable at 125 µg. Most dose adjustments occurred during the first 24 months after surgery. In the time period of 24-48 months after surgery, the dose remained stable in 73.1% of the RYGB patients and in 60.0% of the SG patients. After 48 months in the RYGB group, no significant change in TSH and fT4 levels was observed. CONCLUSIONS: Bariatric surgery led to frequent dose adjustments during the first 2 years after surgery. However, 24-48 months after surgery in the majority of patients, the dosage remained stable. No significant change in TSH and fT4 was observed 48 months after RYGB. In the first 2 years after surgery, clinicians should frequently monitor TSH and fT4 for individual dose adjustment of levothyroxine. Thereafter, the frequency of monitoring may be decreased.


Assuntos
Cirurgia Bariátrica , Derivação Gástrica , Hipotireoidismo , Obesidade Mórbida , Feminino , Gastrectomia , Humanos , Hipotireoidismo/tratamento farmacológico , Hipotireoidismo/cirurgia , Obesidade Mórbida/cirurgia , Estudos Retrospectivos , Tireotropina , Tiroxina/uso terapêutico
11.
Transfusion ; 61(10): 2877-2884, 2021 10.
Artigo em Inglês | MEDLINE | ID: mdl-34480360

RESUMO

BACKGROUND: Ineffective hematopoiesis in patients with myelodysplastic syndromes (MDS) often results in transfusion dependence. The burden of frequent transfusions in the real-world MDS population is largely unknown. STUDY DESIGN AND METHODS: An observational, retrospective, population-based study, using the HemoBase registry, was performed including all patients diagnosed with MDS between 2005 and 2017 in Friesland, a province in the Netherlands with approximately 650,000 inhabitants. Detailed clinical information was collected from the electronic health records. Transfusion burden was classified according to the International Working Group 2018 criteria: not transfusion dependent, low (LTB), or high transfusion burden (HTB). Univariate and multivariable regression analyses were performed. RESULTS: Of 292 patients, 136 (46.6%) had a HTB of ≥8 units/16 weeks and 17 (5.8%) had a LTB of 3-7 units/16 weeks. This was present in all types of MDS patients, but patients aged 75-84 years (odds ratio [OR] 4.02, 95% confidence interval [CI]: 1.84-8.82), high-risk MDS patients (OR 2.88, 95% CI: 1.08-7.68) and MDS-EB-2 patients (OR 7.07, 95% CI: 2.17-22.90) were particularly at risk for a HTB. DISCUSSION: This study provides a reliable estimate of the transfusion burden in real-world MDS patients, with almost half of the patients having a HTB. A HTB was observed in all MDS subtypes and both low- and high-risk MDS. Therefore, we conclude that the entire MDS population might benefit from novel agents that reduce the transfusion need and that might have beneficial effects on patient outcomes and healthcare utilization outcomes.


Assuntos
Transfusão de Sangue , Síndromes Mielodisplásicas/terapia , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Síndromes Mielodisplásicas/epidemiologia , Países Baixos/epidemiologia , Sistema de Registros , Estudos Retrospectivos
12.
Surg Obes Relat Dis ; 17(11): 1912-1918, 2021 11.
Artigo em Inglês | MEDLINE | ID: mdl-34144916

RESUMO

BACKGROUND: Dumping syndrome (DS) and postbariatric hypoglycemia (PBH) are frequent complications of bariatric surgery. Previously known as "early and late dumping," these complications have been separated due to differences in their onset and behaviors. OBJECTIVES: To investigate a potentially common etiology of DS and PBH using an analysis of a mixed meal test (MMT) study. SETTING: A large teaching hospital in the Netherlands. METHODS: From all patients who underwent bariatric surgery in 2008-2011, a random selection completed an MMT (n = 47). Patients scored complaints related to DS and PBH with a standardized questionnaire at several time intervals. The groups were divided into patients with (DS+; n = 22) and without (DS-; n = 25) an increase in DS symptoms after the start of the MMT. Glucose and gut hormone levels were compared. Hypoglycemia was defined as a blood glucose level below 3.3 mmol/L. RESULTS: The DS+ group had lower blood glucose values compared to the DS- group, which reached significance at 90 and 120 minutes (P < .05). For the DS+ group, glucagon-like peptide-1 (GLP-1), peptide YY (PYY), and satiety were higher at various time intervals (P < .05) compared to the DS- group. No differences were found for insulin and hunger score. GLP-1 and PYY were correlated with symptoms of DS. CONCLUSION: Patients with DS complaints had lower postprandial glucose values. GLP-1 and PYY values were elevated in the DS+ group early and late during the test. These hormones also correlated with DS. These findings support the hypothesis of a common etiology of DS and PBH and a role of GLP-1 and PYY in both complications.


Assuntos
Cirurgia Bariátrica , Derivação Gástrica , Hipoglicemia , Obesidade Mórbida , Cirurgia Bariátrica/efeitos adversos , Glicemia , Síndrome de Esvaziamento Rápido/etiologia , Humanos , Hipoglicemia/etiologia , Obesidade Mórbida/cirurgia , Peptídeo YY
13.
Blood Adv ; 5(5): 1344-1351, 2021 03 09.
Artigo em Inglês | MEDLINE | ID: mdl-33656535

RESUMO

Population-based studies that contain detailed clinical data on patients with myelodysplastic syndrome (MDS) are scarce. This study focused on the real-world overall survival (OS) of MDS patients in association with comorbidities, specifically malignancies. An observational population-based study using the HemoBase registry was performed, including all patients with MDS diagnosed between 2005 and 2017 in Friesland, a Dutch province. Detailed information about diagnosis, patient characteristics, previous treatment of malignancies, and comorbidities according to the Charlson Comorbidity Index (CCI) was collected from electronic health records. Patients were followed up until June 2019. Kaplan-Meier plots and Cox regression analyses were used to study survival differences. In the 291 patients diagnosed with MDS, the median OS was 25.3 months (95% confidence interval [CI], 20.3-30.2). OS was significantly better for patients with CCI score <4, age <65 years, female sex, and low-risk MDS. Fifty-seven patients (20%) had encountered a prior malignancy (excluding nonmelanoma skin cancer), and a majority (38 patients; 67%) were therapy related. Both therapy-related and secondary MDSs were associated with worse OS (hazard ratio, 1.51; 95% CI, 1.02-2.23 and 1.58; 95% CI, 0.95-2.65, respectively), as compared with de novo MDS patients (P = .04). Patients in remission at time of MDS diagnosis had a similar median OS compared with patients with de novo MDS (25.5 vs 28.3 months). This population-based study involving all newly diagnosed MDS patients over a 13-year period in Friesland showed that multiple comorbidities, including previous malignancies, are associated with shorter OS. OS was not related to the use of radiotherapy or chemotherapy.


Assuntos
Síndromes Mielodisplásicas , Segunda Neoplasia Primária , Neoplasias , Idoso , Comorbidade , Feminino , Humanos , Síndromes Mielodisplásicas/diagnóstico , Síndromes Mielodisplásicas/epidemiologia , Síndromes Mielodisplásicas/terapia , Segunda Neoplasia Primária/diagnóstico , Segunda Neoplasia Primária/epidemiologia , Modelos de Riscos Proporcionais
14.
BMJ Open ; 11(1): e040336, 2021 01 18.
Artigo em Inglês | MEDLINE | ID: mdl-33462096

RESUMO

OBJECTIVES: For the non-vitamin-K oral anticoagulants, data on bleeding when used for 42 days as thromboprophylaxis after total knee arthroplasty (TKA) are scarce. This pilot study assessed feasibility of a multicentre randomised clinical trial to evaluate major and clinically relevant non-major bleeding during 42-day use of dabigatran, nadroparin and rivaroxaban after TKA. PATIENTS AND METHODS: In 70 weeks, between July 2012 and November 2013, 198 TKA patients were screened for eligibility in the Martini Hospital (Groningen, the Netherlands). Patients were randomly assigned to dabigatran (n=45), nadroparin (n=45) or rivaroxaban (n=48). The primary outcome was the combined endpoint of major bleeding and clinically relevant non-major bleeding. Secondary endpoints of this study were the occurrence of clinical venous thromboembolism (VTE) (pulmonary embolism or deep venous thrombosis), compliance, duration of hospital stay, rehospitalisation, adverse events and Knee Injury and Osteoarthritis Outcome Score (KOOS). RESULTS: The primary outcome was observed in 33.3% (95% CI 20.0% to 49.0%), 24.4% (95% CI 12.9% to 39.5%) and 27.1% (95% CI 15.3% to 41.8%) of patients who received dabigatran, nadroparin or rivaroxaban, respectively (p=0.67). Major bleeding was found in two patients who received nadroparin (p=0.21). Clinically relevant non-major bleeding was observed in 33.3% (95% CI 20.0% to 49.0%), 22.2% (95% CI 11.2% to 37.1%) and 27.1% (95% CI 15.3% to 41.8%) for dabigatran, nadroparin and rivaroxaban, respectively (p=0.51). Wound haematoma was the most observed bleeding event. VTE was found in one patient who received dabigatran (p=0.65). The presurgery and postsurgery KOOS qQuestionnaires were available for 32 (71%), 35 (77%) and 35 (73%) patients for dabigatran, nadroparin and rivaroxaban, respectively. KOOS was highly variable, and no significant difference between treatment groups in mean improvement was observed. CONCLUSIONS: A multicentre clinical trial may be feasible. However, investments will be substantial. No differences in major and clinically relevant non-major bleeding events were found between dabigatran, nadroparin and rivaroxaban during 42 days after TKA. KOOS may not be suitable to detect functional loss due to bleeding. TRIAL REGISTRATION NUMBER: NCT01431456.


Assuntos
Anticoagulantes/uso terapêutico , Artroplastia do Joelho/efeitos adversos , Dabigatrana/uso terapêutico , Nadroparina/uso terapêutico , Rivaroxabana/uso terapêutico , Tromboembolia Venosa/prevenção & controle , Atividades Cotidianas , Anticoagulantes/efeitos adversos , Dabigatrana/efeitos adversos , Feminino , Humanos , Nadroparina/efeitos adversos , Países Baixos , Projetos Piloto , Cuidados Pós-Operatórios , Complicações Pós-Operatórias/prevenção & controle , Qualidade de Vida , Rivaroxabana/efeitos adversos , Resultado do Tratamento , Tromboembolia Venosa/etiologia
15.
Bone ; 134: 115299, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32097762

RESUMO

RATIONALE: While treatment strategies for multiple myeloma have evolved radically over the last decades, little is known about the risk of fractures for symptomatic multiple myeloma patients over time. OBJECTIVE: To determine the effect of different treatment periods (1996-2000, 2001-2006 and 2007-2011) on the risk of fractures in patients with multiple myeloma. METHODS: This retrospective case-control study included patients with multiple myeloma in Denmark, using the Danish National Health Service. Cases were defined as patients who had sustained a fracture between 1996 and 2011, and controls were those without a fracture. Exposure was defined as an ICD code for multiple myeloma. Vertebral fractures, gender, and age were considered in secondary analyses. Conditional logistic regression was used to estimate odd ratios (ORs) of fracture risk, and the analyses were adjusted for comorbidities and recent drug use. RESULTS: The study population consisted of 925,341 cases, and the same number of matched controls, of whom 1334 patients with multiple myeloma. Among cases, the risk of any fracture was higher in multiple myeloma patients compared to patients without multiple myeloma (any fracture: ORadj[95% CI] 1996-2000: 1.7[1.3-2.3]; 2001-2006: 1.3[1.1-1.6]; 2007-2011: 1.7[1.4-2.2]). Although fractures were mainly non-vertebral, the risk of vertebral fractures in particular was higher in multiple myeloma patients (vertebral fracture: ORadj[95% CI] 1996-2000: 3.5[1.4-8.6]; 2001-2006: 4.0[1.9-8.2]; 2007-2011: 3.0[1.6-5.7]). CONCLUSIONS: Despite new treatment strategies and improved supportive care, this study showed no decreased fracture risk for multiple myeloma patients over time. New treatment strategies, even if they have a positive impact on overall survival, offer no guarantee for a corresponding reduction in bone lesions.


Assuntos
Mieloma Múltiplo , Fraturas da Coluna Vertebral , Estudos de Casos e Controles , Dinamarca/epidemiologia , Humanos , Mieloma Múltiplo/complicações , Mieloma Múltiplo/epidemiologia , Estudos Retrospectivos , Fatores de Risco , Fraturas da Coluna Vertebral/complicações , Fraturas da Coluna Vertebral/epidemiologia , Medicina Estatal
16.
World J Pediatr Congenit Heart Surg ; 10(6): 686-693, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31701828

RESUMO

BACKGROUND: To compare the incidence of arrhythmias and the overall survival at long-term follow-up of the right auricular baffle technique (RA) versus Gore-Tex® (GT) baffle as intra-atrial cavopulmonary lateral tunnel, as well as the Nakata index and tunnel dimensions on cardiac magnetic resonance. METHODS: Data were retrospectively collected. Serial 24-hour Holter recordings and cardiac magnetic resonance findings of the two groups were compared. RESULTS: There was no significant difference in the estimated freedom from arrhythmias (87% at 10 years and 78% at 15 years vs 80% at 10 years and 70% at 15 years in RA and GT, respectively; P = .44) nor cumulative survival (86% at 10 years and 84% at 15 years vs 97% at 10 years and 81% at 15 years in RA and GT, respectively; P = .8). Also, no difference between the groups was observed in the Nakata index. The tunnel dimensions on cardiac magnetic resonance were significantly wider in the RA group. In reference to other potential risk indicators, using Cox proportional hazard regression analysis, only age (5 years or older at the time of total cavopulmonary connection) was associated with an increased risk for both arrhythmia and mortality. CONCLUSIONS: This study demonstrated that there was no difference in freedom from arrhythmias, Nakata index, or survival between the two groups. This study confirmed the growth potential of the right auricular tunnel. However, the growth of the tunnel did not influence the incidence of arrhythmias.


Assuntos
Arritmias Cardíacas/etiologia , Técnica de Fontan/métodos , Átrios do Coração/cirurgia , Cardiopatias Congênitas/cirurgia , Politetrafluoretileno , Adolescente , Arritmias Cardíacas/fisiopatologia , Criança , Pré-Escolar , Feminino , Átrios do Coração/anormalidades , Átrios do Coração/diagnóstico por imagem , Cardiopatias Congênitas/diagnóstico , Humanos , Imagem Cinética por Ressonância Magnética , Masculino , Artéria Pulmonar/diagnóstico por imagem , Artéria Pulmonar/cirurgia , Estudos Retrospectivos
17.
Mayo Clin Proc ; 94(10): 2040-2052, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31515105

RESUMO

OBJECTIVES: To assess the diagnostic accuracy of unenhanced computed tomography (CT) attenuation values to exclude a pheochromocytoma in the diagnostic work-up of patients with an adrenal incidentaloma and to model the associated difference in diagnostic costs. METHODS: The MEDLINE and Embase databases were searched from indexing to September 27, 2018, and studies reporting the proportion of pheochromocytomas on either side of the 10-Hounsfield unit (HU) threshold on unenhanced CT were included. The pooled proportion of pheochromocytomas with an attenuation value greater than 10 HU was determined, as were the modeled financial costs of the current and alternative diagnostic approaches. RESULTS: Of 2957 studies identified, 31 were included (N=1167 pheochromocytomas). Overall risk of bias was low. Heterogeneity was not observed between studies (Q=11.5, P=.99, I2=0%). The pooled proportion of patients with attenuation values greater than 10 HU was 0.990 (95% CI, 0.984-0.995). The modeled financial costs using the new diagnostic approach were €55 (∼$63) lower per patient. CONCLUSION: Pheochromocytomas can be reliably ruled out in the case of an adrenal lesion with an unenhanced CT attenuation value of 10 HU or less. Therefore, determination of metanephrine levels can be restricted to adrenal tumors with an unenhanced CT attenuation value greater than 10 HU. Implementing this novel diagnostic strategy is cost-saving.


Assuntos
Neoplasias das Glândulas Suprarrenais/diagnóstico por imagem , Custos e Análise de Custo , Feocromocitoma/diagnóstico por imagem , Tomografia Computadorizada por Raios X/economia , Diagnóstico Diferencial , Humanos , Achados Incidentais , Reprodutibilidade dos Testes
18.
Surg J (N Y) ; 4(4): e220-e225, 2018 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-30402546

RESUMO

Introduction In the Netherlands, clopidogrel monotherapy increasingly replaces acetylsalicylic acid and extended release dipyridamole as the first-choice antiplatelet therapy after ischemic stroke. It is unknown whether the risk of peri- and postoperative hemorrhage in carotid artery surgery is higher in patients using clopidogrel monotherapy compared with acetylsalicylic acid and extended release dipyridamole. We therefore retrospectively compared occurrence of perioperative major and (clinical relevant) minor bleedings during and after carotid endarterectomy of two groups using different types of platelet aggregation inhibition after changing our daily practice protocol in our center. Material and Methods A consecutive series of the most recent 80 carotid endarterectomy patients (November 2015-August 2017) treated with the new regime (clopidogrel monotherapy) were compared with the last 80 (January 2012-November 2015) consecutive patients treated according to the old protocol (acetylsalicylic acid and dipyridamole). The primary endpoint was any major bleeding during surgery or in the first 24 to 72 hours postoperatively. Secondary outcomes within 30 days after surgery included minor (re)bleeding postoperative stroke with persistent or transient neurological deficit, persisting or transient neuropraxia, asymptomatic restenosis or occlusion, (transient) headache. Reporting of this study is in line with the 'Strengthening the Reporting of Observational Studies in Epidemiology' statement. Results Although statistical differences were observed, from a clinical perspective both patients groups were comparable. Postoperative hemorrhage requiring reexploration for hemostasis occurred in none of the 80 patients in the group of the clopidogrel monotherapy (new protocol) and it occurred in one of the 80 patients (1%) who was using acetylsalicylic acid and dipyridamole (old protocol). In three patients (4%) in the clopidogrel monotherapy and one patient (1%) in the acetylsalicylic acid and extended release dipyridamole protocol an ipsilateral stroke was diagnosed. Conclusion In this retrospective consecutive series the incidence of postoperative ischemic complications and perioperative hemorrhage after carotid endarterectomy (CEA) seemed to be comparable in patients using clopidogrel monotherapy versus acetylsalicylic acid and extended release dipyridamole for secondary prevention after a cerebrovascular event. This study fuels the hypothesis that short- and midterm complications of clopidogrel and the combination acetylsalicylic acid and extended release dipyridamole are comparable.

19.
Drugs Aging ; 35(12): 1079-1087, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30345478

RESUMO

BACKGROUND: The prevalence of vitamin D deficiency in nursing home residents ranges from 79% to 98%. OBJECTIVES: The aim of this cross-sectional observational study in somatic and psychogeriatric nursing home residents was to determine the efficacy of a standardized oral vitamin D dosing regimen (VDDR) consisting of a loading dose (LD) of cholecalciferol 200,000 IU followed by a maintenance dose (MD) of 100,000 IU every 13 weeks in obtaining and maintaining an adequate and safe vitamin D trough level (VDTL), defined as 75-220 nmol/L (reference range). METHODS: Blood samples of nursing home residents who had received the LD followed by at least one MD were analyzed for VDTL, calcium, parathyroid hormone, and creatinine. Data on age, sex, race, body weight and height, co-morbidity, co-medication, number of MDs, calcium supplementation, smoking, and use of alcohol were obtained from patient charts. The primary outcome for the efficacy of the VDDR was the percentage of nursing home residents with a VDTL 75-220 nmol/L, with a target percentage of 85% for the dosing regimen to be considered efficacious. RESULTS: In 91 (58%; 95% confidence interval [CI] 50-66) of 156 included nursing home residents, a VDTL within the reference range was measured (mean [standard deviation] 81 [28] nmol/L, range 13-150 nmol/L). The only variable that was identified as a significant risk indicator for obtaining a VDTL ≥ 75 nmol/L was the number of MDs being four or more (≥ 4 vs. < 4; odds ratio 2.7; 95% CI 1.4-5.3). CONCLUSION: This standardized VDDR was not efficacious in obtaining and maintaining an adequate VDTL in this nursing home resident population. CLINICAL TRIALS REGISTRATION NUMBER: NTR6029 (The Netherlands National Trial Register).


Assuntos
Colecalciferol/administração & dosagem , Casas de Saúde , Vitaminas/administração & dosagem , Idoso , Idoso de 80 Anos ou mais , Peso Corporal , Cálcio/sangue , Creatinina/sangue , Estudos Transversais , Relação Dose-Resposta a Droga , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Países Baixos , Hormônio Paratireóideo/sangue , Prevalência , Deficiência de Vitamina D/sangue , Vitaminas/uso terapêutico
20.
Surg Obes Relat Dis ; 14(8): 1106-1117, 2018 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-29937240

RESUMO

BACKGROUND: Circulating amino acids have been associated with both appetite and the secretion of anorexigenic hormones in healthy and obese populations. This effect has not been investigated in subjects having undergone Roux-en-Y gastric bypass surgery (RYGB). OBJECTIVE: To investigate the association between postprandial plasma concentrations of amino acids and the anorexigenic hormones glucagon-like peptide-1 (GLP-1) and peptide tyrosine tyrosine (PYY), the orexigenic hormone ghrelin, and satiety and hunger in post-RYGB subjects. SETTING: A Dutch surgical department. METHODS: Participants after primary RYGB were studied during a Mixed Meal Tolerance Test (MMTT). Satiety and hunger were assessed every 30 minutes on visual analogue scales. Blood samples were collected at baseline, every 10 minutes during the first half hour and every 30 minutes until 210 minutes after the start. The samples were assessed for 24 amino acids and 3 gastrointestinal hormones. Incremental areas under the curve (iAUCs) were calculated. Exploratory analyses were performed in which subjects were divided into high and low responders depending on the median iAUC. RESULTS: 42 subjects, aged 48 ± 11 (mean ± SD) years, 31 to 76 months post-RYGB and with total weight loss of 30 ± 9% completed the MMTT. Subjects with high satiety scores had more than a 25% higher net iAUC of PYY and GLP-1 and at least a 10% higher net iAUC of 10 amino acids compared to subjects with low scores (P < 0.05). The net iAUC of five of these amino acids (i.e. arginine, asparagine, histidine, serine and threonine) was more than 10% higher in subjects with high responses on GLP-1 and/or PYY (P < 0.05). CONCLUSIONS: Certain postprandial amino acids were associated with satiety and anorexigenic hormones and could therefore play a role in appetite regulation after RYGB; either by a direct effect on satiety, indirectly through gastrointestinal hormones, or both.


Assuntos
Aminoácidos/sangue , Apetite/fisiologia , Derivação Gástrica/estatística & dados numéricos , Hormônios Gastrointestinais/sangue , Período Pós-Prandial/fisiologia , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Saciação/fisiologia
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