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1.
Pharmacoepidemiol Drug Saf ; 24(7): 693-700, 2015 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-25974710

RESUMO

PURPOSE: This study aimed to validate a predefined algorithm for osteonecrosis of the jaw (ONJ) among cancer patients in the Danish National Registry of Patients and to assess the nature of clinical information recorded in medical charts of ONJ patients. METHODS: We identified potential ONJ cases recorded in 2005-2010 among cancer patients at the hospital Departments of Oral and Maxillofacial Surgery (DOMS) in three Danish regions, using a set of codes from the International Classification of Diseases, 10th revision (ICD-10). We abstracted DOMS charts of the potential cases, had the ONJ status adjudicated by an expert ONJ adjudication committee (ONJAC), and computed positive predictive values. For patients with ONJAC-confirmed ONJ, we abstracted the charts for information on ONJ clinical course. Sensitivity of the algorithm was computed using a separate sample of 101 known ONJ cases accrued in 2005-2011. RESULTS: We identified 212 potential ONJ cases, of which 197 (93%) had charts available for abstraction. Eighty-three potential cases were confirmed by ONJAC, with a positive predictive value of 42% (95% confidence interval [CI] 35%-49%). DOMS charts of these 83 cases contained complete information on ONJ clinical course. Information about antiresorptive treatment was recorded for 84% of the patients. Among the 101 known ONJ cases, 74 had at least one prespecified ICD-10 code recorded in the Danish National Registry of Patients within ±90 days of the ONJ diagnosis (sensitivity 73%; 95%CI [64%-81%]). CONCLUSIONS: The predefined algorithm is not adequate for monitoring ONJ in pharmacovigilance studies. Additional case-finding approaches, coupled with adjudication, are necessary to estimate ONJ incidence accurately.


Assuntos
Osteonecrose da Arcada Osseodentária Associada a Difosfonatos/diagnóstico , Osteonecrose da Arcada Osseodentária Associada a Difosfonatos/epidemiologia , Conservadores da Densidade Óssea/efeitos adversos , Classificação Internacional de Doenças , Neoplasias/diagnóstico , Idoso , Algoritmos , Dinamarca/epidemiologia , Registros Eletrônicos de Saúde , Feminino , Humanos , Classificação Internacional de Doenças/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Neoplasias/epidemiologia , Farmacoepidemiologia , Sistema de Registros
2.
J Oral Maxillofac Res ; 5(3): e4, 2014 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-25386231

RESUMO

OBJECTIVES: To assess the short term dental and skeletal stability of the anterior maxillary segment after segmental Le Fort I osteotomy with postoperative skeletal elastic fixation with or without occlusal splint. MATERIAL AND METHODS: 29 consecutive patients underwent segmental Le Fort I osteotomy and elastic skeletal fixation was applied. Patients were divided into two groups according to whether a fixed occlusal splint was used for six weeks (group A) or dismounted perioperatively (group B). Changes in landmarks and reference planes between the two timepoints were estimated on lateral cephalometric radiographs. GROUP A: The upper incisor had a mean intrusion of -0.56 mm (SD 0.77; range -2.04 to 1.08 mm) and a mean posterior movement of -0.93 mm (SD 1.03; range -2.52 to 0.96 mm). The mean change in the axial inclination of the upper incisor was -0.33° (SD 2.56; range -6° to 4°) (95% CI: -1.75 to 1.08°). Group B: The upper incisor had a mean intrusion of -0.13 mm (SD 1.36; range -1.92 to 3.6 mm) and a mean anterior movement of 0.11 mm (SD 1.78; range -2.88 to 3.84 mm). The mean change in the axial inclination of the upper incisor was -0.07° (SD 3.05; range -5° to 5°) (95% CI: -1.83 to 1.69°). There was no statistically significant difference in stability between the two groups at the P value 0.05. CONCLUSIONS: The skeletal anterior fixation with postoperative elastics for eight weeks may not compromise the early postoperative dental and skeletal stability of the anterior segment in segmental Le Fort I osteotomy.

3.
Clin Epidemiol ; 5: 263-7, 2013.
Artigo em Inglês | MEDLINE | ID: mdl-23946670

RESUMO

BACKGROUND: Osteonecrosis of the jaw (ONJ) is an adverse effect of drugs that suppress bone turnover - for example, drugs used for the treatment of postmenopausal osteoporosis. The Danish National Registry of Patients (DNRP) is potentially valuable for monitoring ONJ and its prognosis; however, no specific code for ONJ exists in the International Classification of Diseases 10th revision (ICD-10), which is currently used in Denmark. Our aim was to estimate the positive predictive value (PPV) of an algorithm to capture ONJ cases in the DNRP among women with postmenopausal osteoporosis. METHODS: We conducted this cross-sectional validation study in the Central and North Denmark Regions, with approximately 1.8 million inhabitants. In total, 54,956 women with postmenopausal osteoporosis were identified from June 1, 2005 through May 31, 2010. To identify women potentially suffering from ONJ, we applied an algorithm based on ICD-10 codes in the DNRP originating from hospital-based departments of oral and maxillofacial surgery (DOMS). ONJ was adjudicated by chart review and defined by the presence of exposed maxillofacial bone for 8 weeks or more, in the absence of recorded history of craniofacial radiation therapy. We estimated the PPV for the overall algorithm and for each separate ICD-10 code used in the algorithm. RESULTS: Charts were obtained and reviewed for all 60 women with an ICD-10 code potentially representing ONJ. Nineteen potential ONJ cases were confirmed, corresponding to an overall PPV of 32% (95% confidence interval: 20%-45%). CONCLUSION: Among women with postmenopausal osteoporosis, only about one-third of the potential ONJ cases identified by our ICD-10 based algorithm were confirmed by medical chart review, despite the restriction to patients treated at DOMS. To capture true ONJ cases among women with postmenopausal osteoporosis, alternative approaches are needed.

4.
Cancer Epidemiol ; 36(4): 381-3, 2012 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-22534488

RESUMO

BACKGROUND: Osteonecrosis of the jaw (ONJ) is an important adverse event associated with therapies suppressing bone turnover, especially in patients with high-dose regimens of antiresorptive therapy, such as cancer patients. Danish health registries are an important resource for monitoring side effects of drugs. The International Classification of Diseases, 10th revision (ICD-10), currently used in Denmark, does not have a specific code for ONJ, making it difficult to monitor its occurrence. OBJECTIVES: To estimate the positive predictive value (PPV) for ONJ of currently used ICD-10 codes, suggested by Danish oral and maxillofacial surgeons, in order to assess feasibility of identification of ONJ cases among cancer patients in the Danish National Registry of Patients (DNRP). METHODS: This study was conducted in northern Denmark (1.8 million inhabitants) among patients with a history of cancer. In Denmark ONJ cases are referred to hospital-based departments of oral and maxillofacial surgery (DOMS). In the DNRP, we identified patients with potential ONJ diagnosed at DOMS (as suggested by a series of ICD-10 codes) from 1 January 2005 to 31 December 2009. To confirm or rule out ONJ, we reviewed hospital records of these patients originating from DOMS. A confirmed ONJ case was defined by the presence of exposed maxillofacial bone for 8 weeks or more, in the absence of previous craniofacial radiation therapy. The PPV was the proportion of confirmed cases among all potential cases. RESULTS: Among 85,910 eligible cancer patients, we identified 91 (0.11%) potential cases of ONJ, of which 18 were confirmed. The overall PPV was 20% (95% CI: 12-29%), ranging from 0% to50% for individual ICD-10 codes. CONCLUSIONS: A majority of cases identified by the suggested ICD-10 codes did not fulfill the criteria for ONJ, even though the potential cases were identified at DOMS. Therefore, reliance on ICD-10 codes, without hospital chart review, will lead to an overestimation of the occurrence of ONJ among cancer patients.


Assuntos
Classificação Internacional de Doenças/normas , Doenças Maxilomandibulares/diagnóstico , Doenças Maxilomandibulares/epidemiologia , Neoplasias/epidemiologia , Osteonecrose/diagnóstico , Osteonecrose/epidemiologia , Idoso , Dinamarca/epidemiologia , Difosfonatos/efeitos adversos , Difosfonatos/uso terapêutico , Feminino , Humanos , Doenças Maxilomandibulares/etiologia , Masculino , Pessoa de Meia-Idade , Neoplasias/complicações , Neoplasias/tratamento farmacológico , Osteonecrose/etiologia , Valor Preditivo dos Testes
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