Psychometric characteristics of the "General Oral Health Assessment Index (GOHAI) ¼ in a French representative sample of patients with schizophrenia.

BACKGROUND: The "General Oral Health Assessment Index" (GOHAI) was widely used in clinical or epidemiological studies worldwide, as it was available for use in different languages. Therefore, the aim of this study was to evaluate the psychometric characteristics of the GOHAI in a representative sample of patients with schizophrenia. METHODS: A total of 90 schizophrenic patients (in-patients and out-patients) were recruited from the participants of the "buccodor study" (NCT02167724) between March and September 2015. They were selected using a random stratified sampling method according to their age, sex, or residential area (urban/rural area). GOHAI validity (construct, predictive, concurrent and known group validity) and internal consistency (reliability) were tested. Test-retest reliability was evaluated in 32 subjects. RESULTS: The mean age was 47.34 (SD = 12.17). Internal consistency indicated excellent agreement, with a Cronbach's α value of 0.82 and average inter-item correlation of 0.65. Intraclass correlation coefficients for test-retest reliability with 95% confidence intervals were not significantly different (p > 0.05). Construct validity was supported by three factor that accounted for 60.94% of the variance observed. Predictive validity was corroborated as statistically significant differences were observed between a high GOHAI score, which was associated with self-perceived satisfaction with oral health, lower age and high frequency of toothbrushing. Concurrent validity was corroborated as statistically significant relationships were observed between the GOHAI scores and most objective measures of dental status. For known group validity, they was no significant difference of the mean GOHAI score between out or in-patients (p > 0.05). CONCLUSION: Acceptable psychometric characteristics of the GOHAI could help caregivers to develop ways to improve the Oral Health related Quality Of Life of schizophrenic patients. TRIAL REGISTRATION: Clinical Trials Gov NCT02167724 . Date registered 17 June, 2014.

Analgesic efficacy of an oral transmucosal spray formulation of meloxicam alone or in combination with tramadol in cats with naturally occurring osteoarthritis.

OBJECTIVE: To evaluate the analgesic efficacy of meloxicam oral transmucosal spray (OTMS) alone and with tramadol in cats with osteoarthritis (OA). STUDY DESIGN: Randomized, blinded study. ANIMALS: Fifteen geriatric cats weighing 4.5 ± 1.0 kg. METHODS: Healthy cats with OA were randomly administered a placebo (every 12 hours orally) and meloxicam OTMS (approximately 0.05 mg kg-1 every 24 hours) (group M, n = 7), or tramadol (3 mg kg-1 every 12 hours orally) and meloxicam OTMS (group TM, n = 8) for 25 days. Evaluations performed before treatment (D0) and at week 3 (W3) consisted of peak vertical force, motor activity and response to mechanical temporal summation of pain (RMTS). Data were analyzed with mixed models and Fisher's exact test. RESULTS: Mean ± standard deviation peak vertical force (percentage of body weight) increased significantly in both groups (p = 0.02), from 47.7 ± 6.5% to 60.5 ± 9.4% in group M, and from 51.8 ± 5.0% to 64.1 ± 6.5% in group TM, with no difference between groups. Motor activity increased in M (from 43 ± 12 to 56 ± 13; p = 0.02), but not in TM. The number of stimulations from RMTS increased in TM only. Cut-off values were reached in a larger number of cats (n = 5) in TM than M (n = 1) (p < 0.05). Gastrointestinal adverse effects were self-limiting in six cats, including five in TM. CONCLUSIONS AND CLINICAL RELEVANCE: Meloxicam OTMS had similar effects on peak vertical force, motor activity and pain sensitization as previously reported for oral meloxicam in OA cats. The tramadol-meloxicam combination provided no evident benefit over meloxicam alone, except for central hypersensitivity (assessed with RMTS). Further assessment of the potential toxicity of the combination is required prior to clinical use. Gingival administration was well accepted overall.

Peginterferon beta-1a in multiple sclerosis: 2-year results from ADVANCE.

OBJECTIVE: To evaluate the efficacy and safety of subcutaneous peginterferon beta-1a over 2 years in patients with relapsing-remitting multiple sclerosis in the ADVANCE study. METHODS: Patients were randomized to placebo or 125 µg peginterferon beta-1a every 2 or 4 weeks. For Year 2 (Y2), patients originally randomized to placebo were re-randomized to peginterferon beta-1a every 2 weeks or every 4 weeks. Patients randomized to peginterferon beta-1a in Year 1 (Y1) remained on the same dosing regimen in Y2. RESULTS: Compared with Y1, annualized relapse rate (ARR) was further reduced in Y2 with every 2 week dosing (Y1: 0.230 [95% CI 0.183-0.291], Y2: 0.178 [0.136-0.233]) and maintained with every 4 week dosing (Y1: 0.286 [0.231-0.355], Y2: 0.291 [0.231-0.368]). Patients starting peginterferon beta-1a from Y1 displayed improved efficacy versus patients initially assigned placebo, with reductions in ARR (every 2 weeks: 37%, p<0.0001; every 4 weeks: 17%, p=0.0906), risk of relapse (every 2 weeks: 39%, p<0.0001; every 4 weeks: 19%, p=0.0465), 12-week disability progression (every 2 weeks: 33%, p=0.0257; every 4 weeks: 25%, p=0.0960), and 24-week disability progression (every 2 weeks: 41%, p=0.0137; every 4 weeks: 9%, p=0.6243). Over 2 years, greater reductions were observed with every 2 week versus every 4 week dosing for all endpoints and peginterferon beta-1a was well tolerated. CONCLUSIONS: Peginterferon beta-1a efficacy is maintained beyond 1 year, with greater effects observed with every 2 week versus every 4 week dosing, and a similar safety profile to Y1.Clinicaltrials.gov REGISTRATION NUMBER: NCT00906399.

MFI-11 Predicts Post-Operative Serious Complications in Patients Undergoing Surgery for Odontoid Fractures.

STUDY DESIGN: Retrospective Cohort. OBJECTIVES: The objective of this study was to analyze postoperative complications in different mFI-11 groups after surgery for odontoid fractures in a geriatric population. METHODS: A single center retrospective review of odontoid fractures surgery (between 2013 and 2022) in patients aged 65 years and older was conducted. The primary outcome was the occurrence of a major complication (Calvien-Dindo ≥4) within 30 days post-surgery. The secondary outcome was the occurrence of a major complication within 3 months after surgery, and death within 1-month post-surgery. Survival curve, multi-variate analysis was performed and adjusted receiver operating characteristic curves were generated. RESULTS: There were 92 patients included in this study, with a mean age of 80.5 years. Serious complication occurred for 16 patients (17%) during hospitalization. Multivariate analysis demonstrated an mFI 11 >.27 was strongly and independently associated with serious complications within 1-month post-surgery (OR = 16.7, 95% CI = 4.50-83), as well as serious complications within 3 months post-surgery (OR = 11.8, 95% CI = 3.48-49.1) and death within 1 month post-surgery (OR = 11.7; 95% CI = 3.02-60.4). The Receiver Operator Characteristics (ROC) curves for the three models all have an Area Under the Curve (AUC) value greater than 0.7. CONCLUSIONS: The mFI-11 is a straightforward and validated tool that can be used during the preoperative period to identify the patient's level of frailty and assess their risk of postoperative complications. Patients with mFI-11 ≥.27 are at greater risk of serious complications within 1 and 3 months' post-surgery and death within 1 month post-surgery.

Conservative versus Surgical Treatment for Odontoid Fracture: Is the Surgical Treatment Harmful? Systematic Review and Meta-Analysis.

BACKGROUND: Odontoid fracture is a common injury especially in elderly people. Despite some recent studies arguing in favor of surgery, the best treatment is still being debated. OBJECTIVE: We systematically review and analyze the comparative literature between surgical and conservative treatments of odontoid fractures. METHODS: We systematically searched Medline and the Cochrane Library for studies reported from January 1990 to May 2019 in English. Comparative studies evaluating the results of surgical and conservative treatments for odontoid fractures were eligible for inclusion. Combined relative risks (RRs) for mortality at last follow-up, union or nonunion rates, and complications were calculated. Methodological quality was assessed using the Newcastle-Ottawa Scale. Influence of age and year of publication on treatment effect was explored using a meta-regression analysis. RESULTS: A total of 1438 articles were identified, of which 30 articles with 2463 patients were eligible for inclusion. There was a trend toward lower mortality in the surgical group (RR, 0.80; 95% confidence interval [CI], 0.63-1.02). Nonunion rates (RR, 0.41; 95% CI, 0.28-0.6) were lower in the surgical group. Union rates were higher in the surgical group (RR, 1.26; 95% CI, 1.11-1.45). No significant influence of age or year of publication on treatment effect was found. CONCLUSIONS: Based on this meta-analysis of nonrandomized comparative studies, surgical treatment seems not to be inferior to conservative treatments. The conclusions of this study remain limited by the low quality of the evidence available. Randomized controlled studies are required.

Coping Strategies for Oral Health Problems by People with Schizophrenia.

BACKGROUND: Persons with schizophrenia are particularity susceptible to poor oral health. Symptoms of schizophrenia often affect oral health behaviors and lifestyle. The aim was to explore coping strategies used by people with schizophrenia in oral health in order to understand and to best involve them in the management of their own oral health in daily life. MATERIALS AND METHODS: This is systematic review reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statements. We included cross-sectional and longitudinal quantitative and qualitative studies that 1) examined coping strategies regarding oral health in persons with schizophrenia or 2) examined coping strategies were used in dental care. We included studies conducted with at least one PWS aged 18 years old more and without restriction on sex, socioeconomic status, or language. RESULTS: The 8 studies included suggest that coping strategies depends on complex translation processes that can be either personal (e.g., psychological symptomatology, neuropsychological functioning to adversely affect hope, self-esteem, self-stigma, self-determination, sense of coherence, and resilience) and/or environmental factors (e.g., peer support and efficacy of rehabilitations programs). We further identified that the main factor influencing coping strategies was dental stress situation. CONCLUSIONS: This review suggests that coping strategies play a crucial role in the recovery process for oral health of PWS. Translation processes in oral health should be more explored in the future to clarify the capacity of PWS to cope with essential self-care in oral health on daily life.

A Therapeutic Educational Program in Oral Health for Persons with Schizophrenia: A Qualitative Feasibility Study.

OBJECTIVE: The aim of this study was to test the feasibility of a therapeutic educational program in oral health (TEPOH) for persons with schizophrenia (PWS). DESIGN: In a qualitative study, we explored the representation of oral health before and after a TEPOH. Clinical Setting: PWS are at greater risk of decayed and missing teeth and periodontal diseases. In a previous publication, we described the different steps in building a TEPOH by taking into account the experiences of PWS concerning oral health quality of life. This TEPOH aimed at promoting a global health approach. Participants: Voluntary PWS and their caregivers were recruited during face-to-face interviews at "Les Boisseaux" (a psychiatric outpatient centre) in Auxerre (France) and were included in the study between November and December 2016. Intervention: We explored the experiences of participants and their perceptions of oral health before and after the TEPOH with focus group meetings. RESULTS: Four females and three males participated in the study, and the mean age was 29.4 ± 5. Before the TEPOH, the PWS produced 28 ideas about oral health perception and 37 after the TEPOH. After the TEPOH, elements relating to the determinants of oral health (smoking and poor diet) emerged. CONCLUSIONS: These results show an evolution in oral health representation, and after some adjustments to the TEPOH, the second step will be to test this program in a large sample to generate a high level of evidence of the impact of TEPOH in the long term.

On the Potential of Bulk Metallic Glasses for Dental Implantology: Case Study on Ti40Zr10Cu36Pd14.

Ti40Zr10Cu36Pd14 Bulk Metallic Glass (BMG) appears very attractive for future biomedical applications thanks to its high glass forming ability, the absence of toxic elements such as Ni, Al or Be and its good mechanical properties. For the first time, a complete and exhaustive characterization of a unique batch of this glassy alloy was performed, together with ISO standard mechanical tests on machined implant-abutment assemblies. The results were compared to the benchmark Ti-6Al-4V ELI (Extra-Low-Interstitial) to assess its potential in dental implantology. The thermal stability, corrosion and sterilization resistance, cytocompatibility and mechanical properties were measured on samples with a simple geometry, but also on implant-abutment assemblies' prototypes. Results show that the glassy alloy exhibits a quite high thermal stability, with a temperature range of 38 °C between the glass transition and crystallization, a compressive strength of 2 GPa, a certain plastic deformation (0.7%), a hardness of 5.5 GPa and a toughness of 56 MPa.√m. Moreover, the alloy shows a relatively lower Young's modulus (96 GPa) than the Ti-6Al-4V alloy (110-115 GPa), which is beneficial to limit bone stress shielding. The BMG shows a satisfactory cytocompatibility, a high resistance to sterilization and a good corrosion resistance (corrosion potential of -0.07 V/SCE and corrosion current density of 6.0 nA/cm²), which may ensure its use as a biomaterial. Tests on dental implants reveal a load to failure 1.5-times higher than that of Ti-6Al-4V and a comparable fatigue limit. Moreover, implants could be machined and sandblasted by methods usually conducted for titanium implants, without significant degradation of their amorphous nature. All these properties place this metallic glass among a promising class of materials for mechanically-challenging applications such as dental implants.

Pegylated interferon ß-1a for relapsing-remitting multiple sclerosis (ADVANCE): a randomised, phase 3, double-blind study.

BACKGROUND: Subcutaneous pegylated interferon (peginterferon) beta-1a is being developed for treatment of relapsing multiple sclerosis, with less frequent dosing than currently available first-line injectable treatments. We assessed the safety and efficacy of peginterferon beta-1a after 48 weeks of treatment in the placebo-controlled phase of the ADVANCE trial, a study of patients with relapsing-remitting multiple sclerosis. METHODS: We did this 2-year, double-blind, parallel group, phase 3 study, with a placebo-controlled design for the first 48 weeks, at 183 sites in 26 countries. Patients with relapsing-remitting multiple sclerosis (age 18-65 years, with Expanded Disability Status Scale score ≤5) were randomly assigned (1:1:1) via an interactive voice response or web system, and stratified by site, to placebo or subcutaneous peginterferon beta-1a 125 µg once every 2 weeks or every 4 weeks. The primary endpoint was annualised relapse rate at 48 weeks. This trial is registered with ClinicalTrials.gov, number NCT00906399. FINDINGS: We screened 1936 patients and enrolled 1516, of whom 1512 were randomly assigned (500 to placebo, 512 to peginterferon every 2 weeks, 500 to peginterferon every 4 weeks); 1332 (88%) patients completed 48 weeks of treatment. Adjusted annualised relapse rates were 0·397 (95% CI 0·328-0·481) in the placebo group versus 0·256 (0·206-0·318) in the every 2 weeks group and 0·288 (0·234-0·355) in the every 4 weeks group (rate ratio for every 2 weeks group 0·644, 95% CI 0·500-0·831, p=0·0007; rate ratio for the every 4 weeks group 0·725, 95% CI 0·565-0·930, p=0·0114). 417 (83%) patients taking placebo, 481 (94%) patients taking peginterferon every 2 weeks, and 472 (94%) patients taking peginterferon every 4 weeks reported adverse events including relapses. The most common adverse events associated with peginterferon beta-1a were injection site reactions, influenza-like symptoms, pyrexia, and headache. 76 (15%) patients taking placebo, 55 (11%) patients taking study drug every 2 weeks, and 71 (14%) patients taking study drug every 4 weeks reported serious adverse events; relapse, pneumonia, and urinary tract infection were the most common. INTERPRETATION: After 48 weeks, peginterferon beta-1a significantly reduced relapse rate compared with placebo. The drug might be an effective treatment for relapsing-remitting multiple sclerosis with less frequent administration than available treatments. FUNDING: Biogen Idec.