Biopsychosocial complexity in functional neurological disorder.

BACKGROUND: Functional Neurological Disorder (FND) is considered a biopsychosocial disorder nowadays, with chronicity in >50% of cases. The INTERMED Self-Assessment Questionnaire (IMSA) assesses the various domains and indicates biopsychosocial complexity. OBJECTIVE: FND patients were compared with a sample of psychosomatic (PSM) patients as well as post-stroke patients. METHODS: The three samples (N = 287 altogether) were largely in inpatient and day clinic psychotherapeutic treatment or inpatient neurological rehabilitation. The IMSA covers all three biopsychosocial domains as well as health care utilisation in the time frame of the past, the present and the future. In addition, affective burden (GAD-7, PHQ-9), somatoform symptoms (PHQ-15), dissociation (FDS) and quality of life (SF-12) were evaluated. RESULTS: FND and PSM patients scored highly in the IMSA, with ≥70% regarded as complex, compared to 15% of post-stroke patients. Affective, somatoform and dissociation scores were high in FND and PSM patients. Mental and somatic quality of life were lower in these groups compared to post-stroke patients. DISCUSSION: FND patients showed high biopsychosocial strain, similar to a typical sample of inpatient and day clinic, i.e. severely affected, PSM patients, and they were more affected than post-stroke patients. These data emphasize that FND should be evaluated with a biopsychosocial perspective. The IMSA likely represents a valuable tool, which has to be assessed by further longitudinal studies.

Mandible handling in the surgical treatment of oral squamous cell carcinoma: lessons from clinical results after marginal and segmental mandibulectomy.

OBJECTIVE: The aim of this retrospective, single-center study was to analyze long-term results after marginal and segmental mandibulectomies in patients with oral squamous cell carcinoma (OSCC). STUDY DESIGN: The study included 259 patients treated for OSCC with mandibulectomy between 1996 and 2010. Data acquisition consisted of analysis of operation reports, re-evaluation of histologic bone specimens, and collection of clinical follow-up data. RESULTS: Of the included patients, 86.5% had received segmental and 13.5% marginal mandibulectomies. Patients who received segmental mandibulectomy generally displayed a higher TNM (tumor-node-metastasis) stage; 47% of patients who received segmental mandibulectomy and 14% of those receiving marginal mandibulectomy showed bone infiltration (pT4 a). Of all patients with bone infiltration, 49% showed an invasive histologic infiltration pattern, and 35% showed an erosive histologic infiltration pattern. We found healthy residual crestal bone height in 43% of all segmental mandibulectomies. Only 8% of all patients were prosthodontically rehabilitated. With regard to prognostic parameters, there was no significant difference between patients receiving marginal mandibulectomy and those receiving segmental mandibulectomy. CONCLUSIONS: Because healthy residual crestal bone height was found in 43% of all patients who had received segmental mandibulectomies, it is conceivable that a significant number of patients would profit from marginal mandibulectomy, at least in cases of absent or erosive bone infiltration pattern, because the residual crestal bone is functionally stable.

CT-scan is a valuable tool to detect mandibular involvement in oral cancer patients.

In patients with oral squamous cell carcinomas (OSSC) it is desirable to avoid unnecessary bone resection without neglecting the overall surgical treatment goal of tumor-free margins. Whereas computed tomography (CT) is most commonly used to detect mandibular invasion, there are conflicting reports regarding the accuracy of CT. Therefore, the aim of this study was to reinvestigate the accuracy of CT in predicting mandibular involvement by OSSC. One hundred and seven patients with OSSC who received a mandibulectomy were included. Before treatment all patients underwent a contrast-enhanced multi-detector CT. Axial 3 or 1.25 mm thick images were reconstructed for evaluation in overlapping technique and displayed in a bone (1400/400 HU) and a soft tissue window (350/50 HU). CT scans were examined by three investigators and compared with the histological findings. The radiological examination showed a high interrater reliability (Cronbachs alpha 0.982). Comparing the radiological findings with the histological results the CT showed 8 false-positive results and 8 false-negative patients. The quality criteria for detecting bone involvement of OSSC by CT were calculated as follows: sensitivity 82.6%; specificity 86.9%; positive predictive value 82.6%; negative predictive value 86.9%. However, in all false-positive patients a sagittal bone defect of 15.1mm could be found presumably caused by pressure of the tumor, but no histologically detectable bone infiltration. Modern CT (1-2 mm sections) is a valuable tool for surgical treatment planning. If bone invasion is detected, a mandibulectomy seems always reasonable. In radiologically negative cases histological assessment is necessary to detect mandibular involvement.

Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis.

BACKGROUND: A single infusion of intravenous zoledronic acid decreases bone turnover and improves bone density at 12 months in postmenopausal women with osteoporosis. We assessed the effects of annual infusions of zoledronic acid on fracture risk during a 3-year period. METHODS: In this double-blind, placebo-controlled trial, 3889 patients (mean age, 73 years) were randomly assigned to receive a single 15-minute infusion of zoledronic acid (5 mg) and 3876 were assigned to receive placebo at baseline, at 12 months, and at 24 months; the patients were followed until 36 months. Primary end points were new vertebral fracture (in patients not taking concomitant osteoporosis medications) and hip fracture (in all patients). Secondary end points included bone mineral density, bone turnover markers, and safety outcomes. RESULTS: Treatment with zoledronic acid reduced the risk of morphometric vertebral fracture by 70% during a 3-year period, as compared with placebo (3.3% in the zoledronic-acid group vs. 10.9% in the placebo group; relative risk, 0.30; 95% confidence interval [CI], 0.24 to 0.38) and reduced the risk of hip fracture by 41% (1.4% in the zoledronic-acid group vs. 2.5% in the placebo group; hazard ratio, 0.59; 95% CI, 0.42 to 0.83). Nonvertebral fractures, clinical fractures, and clinical vertebral fractures were reduced by 25%, 33%, and 77%, respectively (P<0.001 for all comparisons). Zoledronic acid was also associated with a significant improvement in bone mineral density and bone metabolism markers. Adverse events, including change in renal function, were similar in the two study groups. However, serious atrial fibrillation occurred more frequently in the zoledronic acid group (in 50 vs. 20 patients, P<0.001). CONCLUSIONS: A once-yearly infusion of zoledronic acid during a 3-year period significantly reduced the risk of vertebral, hip, and other fractures. (ClinicalTrials.gov number, NCT00049829.)

The HORIZON Recurrent Fracture Trial: design of a clinical trial in the prevention of subsequent fractures after low trauma hip fracture repair.

OBJECTIVE: To present the novel design of a trial testing the safety and efficacy of a yearly bisphosponate, zoledronic acid, in preventing new clinical fractures in patients with recent low trauma hip fracture repair. RESEARCH DESIGN AND METHODS: Randomized, placebo-controlled, triple-blind study. One hundred and fifteen clinical centers worldwide are recruiting approximately 1714 subjects aged 50 years and over (no upper age limit, median age of enrolled subjects to date 79 years) who have undergone surgical repair of a low trauma hip fracture in the preceding 90 days. Patients will be assigned at random to an intervention group (5 mg zoledronic acid intravenously yearly) or a control group (placebo infusion yearly). Both groups receive a loading dose of Vitamin D2 or D3 IM or orally, followed by 800-1200 IU Vitamin D and 1000-1500 mg elemental calcium orally on a daily basis. Concomitant therapy with calcitonin, hormone replacement therapy, selective estrogen receptor modulators, tibolone, and external hip protectors are allowed. MAIN OUTCOME MEASURES: The primary endpoint is subsequent skeletal fractures as adjudicated by a clinical endpoints committee blinded to intervention status. Secondary outcomes include delayed hip fracture healing, changes in bone mineral density, and health resource utilization. Subjects will be recruited over a 3-4 year period and will be followed until 211 primary endpoints are accrued and adjudicated. CONCLUSIONS: This randomized clinical trial is novel among osteoporosis therapies as it (1). targets hip fracture patients, a previously understudied group, and (2). uses only clinically evident fractures as the primary outcome. Ethical and practical considerations in studying this frail population are discussed.