Development and preliminary evaluation of the psychometric properties of the psychological flexibility in epilepsy questionnaire (PFEQ).

The present study describes the development and preliminary psychometric evaluation of the Psychological Flexibility in Epilepsy Questionnaire (PFEQ), which was developed to measure the construct referred to as Psychological Flexibility (PF) in epilepsy. Results from 81 participants with epilepsy support a one-factor solution, consisting of 12 items, indicating a satisfactory structure and reliability with an alpha coefficient of 0.92. Criterion validity of the instrument was supported by moderate correlations with outcomes predicting quality of life, PF in the general population, depressive symptoms, and anxiety symptoms. Number of seizures in the past three and 12 months was positively correlated with scores on the PFEQ. These findings are consistent with the instrument's underlying theory. Further development and investigation of the PFEQ is recommended, as the preliminary results of the questionnaire suggest that the scale has the potential to be a valuable contribution to the future exploration of the role of PF in epilepsy.

Efficacy and safety of sequential versus quadruple therapy as second-line treatment for helicobacter pylori infection-A randomized controlled trial.

BACKGROUND AND AIMS: Quadruple therapy is recommended as second-line treatment for Helicobacter pylori eradication failure. However, high cost, multiple side effects, and low adherence rates are major drawbacks to its routine use. Our aim was to compare the efficacy and safety of sequential versus quadruple regimens as second line treatment for persistent Helicobacter pylori infection. METHODS: Prospective, randomized, open label trial was conducted at a large academic, tertiary care center in Israel. Patients who previously failed a standard triple treatment eradication course were randomly assigned (1:1) to receive a 10-day sequential therapy course, or a 14-day quadruple regimen. Compliance and adverse events were evaluated by telephone questionnaires. The primary endpoint for analysis was the rate of Helicobacter pylori eradication as defined by either a negative 13C-urea breath-test, or stool antigen test, 4-16 weeks after treatment assessed under the non-inferiority hypothesis. The trial was terminated prematurely due to low recruitment rates. See S1 Checklist for CONSORT checklist. RESULTS: One hundred and one patients were randomized. Per modified intention-to-treat analysis, eradication rate was 49% in the sequential versus 42.5% in the quadruple regimen group (p-value for non-inferiority 0.02). Forty-two (84.0%) versus 33 (64.7%) patients completed treatment in the sequential and quadruple groups respectively (p 0.027). Gastrointestinal side effects were more common in the quadruple regimen group. CONCLUSION: Sequential treatment when used as a second line regimen, was non-inferior to the standard of care quadruple regimen in achieving Helicobacter pylori eradication, and was associated with better compliance and fewer adverse effects. Both treatment protocols failed to show an adequate eradication rate in the population of Southern Israel. TRIAL REGISTRATION: ClinicalTrials.gov NCT01481844.