Translation, Cross-cultural Adaptation and Validation of the Farsi Version of NIH Task Force's Recommended Multidimensional Minimal Dataset for Research on Chronic Low Back Pain.

STUDY DESIGN: Translation and cultural adaptation of the National Institutes of Health (NIH) Task Force's minimal dataset. OBJECTIVE: The purpose of this study was to evaluate validity and reliability of the Farsi version of NIH Task Force's recommended multidimensional minimal dataset for research on chronic low back pain (CLBP). SUMMARY OF BACKGROUND DATA: Considering the high treatment cost of CLBP and its increasing prevalence, NIH Pain Consortium developed research standards (including recommendations for definitions, a minimum dataset, and outcomes' report) for studies regarding CLBP. Application of these recommendations could standardize research and improve comparability of different studies in CLBP. METHODS: This study has three phases: translation of dataset into Farsi and its cultural adaptation, assessment of pre-final version of dataset's comprehensibility via a pilot study, and investigation of the reliability and validity of final version of translated dataset. Subjects were 250 patients with CLBP. Test-retest reliability, content validity, and convergent validity (correlations among different dimensions of dataset and Farsi versions of Oswestry Disability Index, Roland Morris Disability Questionnaire, Fear-Avoidance Belief Questionnaire, and Beck Depression Inventory-II) were assessed. RESULTS: The Farsi version demonstrated good/excellent convergent validity (the correlation coefficient between impact dimension and ODI was r = 0.75 [P < 0.001], between impact dimension and Roland-Morris Disability Questionnaire was r = 0.80 [P < 0.001], and between psychological dimension and BDI was r = 0.62 [P < 0.001]). The test-retest reliability was also strong (intraclass correlation coefficient value ranged between 0.70 and 0.95) and the internal consistency was good/excellent (Chronbach's alpha coefficients' value for two main dimensions including impact dimension and psychological dimension were 0.91 and 0.82 [P < 0.001], respectively). In addition, its face validity and content validity were acceptable. CONCLUSION: The Farsi version of minimal dataset for research on CLBP is a reliable and valid instrument for data gathering in patients with CLBP. This minimum dataset can be a step toward standardization of research regarding CLBP. LEVEL OF EVIDENCE: 3.

Drug adherence of patients with epilepsy in Iran: the effects of the international economic sanctions.

Drug adherence of patients with epilepsy was investigated to determine the reasons behind poor adherence. In this retrospective chart review study, all patients with a clinical diagnosis of epilepsy were recruited at the outpatient epilepsy clinic at Shiraz University of Medical Sciences. We routinely asked about the patient's drug adherence and reasons behind poor drug adherence in every office visit. We defined drug adherence adequate if the patient reported less than or equal to one missed dose per month. Patients' drug adherences were investigated during two time periods: March 2010-2011 (before intensification of the international economic sanctions against Iran), and September 2012-2013 (during intensified international economic sanctions). One hundred and ninety-nine patients were studied. Drug adherence was satisfactory in 139 patients (69.8 %) during the first time period. Drug adherence was satisfactory in 146 patients (73.4 %) during the second time period. The most common reasons for poor drug adherence was carelessness, followed by cost and lack of drug availability (1.5 % in the first time period and 4 % in the second time period; P = 0.07). About one-third of patients with epilepsy had poor drug adherence. To overcome the problem, it is important to find the reasons behind poor drug adherence in each patient and try to overcome the cause. Purely from a clinical and patient care perspective, it seems necessary that politicians should facilitate decisions that make the health and well-being of ordinary people more affordable and without hardship.

Factors related to biopsy willingness in patients with advanced cancer in a phase 1 clinic for molecularly targeted therapy.

PURPOSE: Tumor biopsies are critical for delineating pharmacodynamic effects of drugs and for optimal patient selection during oncology clinical trials of molecular targeted therapies. The purpose of this study was to identify factors related to patients' willingness to provide study-related tumor biopsies in phase 1 clinical trials of molecularly targeted therapy. METHODS: An investigator-designed survey, that assessed biopsy willingness, demographic and clinical factors, was completed anonymously by patients with advanced cancer in a phase 1 clinic for targeted therapy. Data were analyzed using multivariate logistic regression models with odds ratios (OR) and 95 % confidence intervals (CI). RESULTS: Three hundred and sixty-two patients with advanced cancer (50 % male, 56 % aged ≤ 60 years) participated. In univariate analyses, willingness to provide study-related biopsy was associated with male gender, white race, higher income, using the Internet for cancer-related information, and having had a biopsy previously (p < 0.05). In multivariate analyses, male gender (OR 2.41, 95 % CI 1.54, 3.78) and having had a biopsy (OR 3.71, 95 % CI 1.68, 8.15) were associated with willingness to have one biopsy; male gender (OR 1.97, 95 % CI 1.30, 3.00) and relying on the Internet as a source of information (OR 1.87, 95 % CI 1.21, 2.89) were associated with willingness to have more than one biopsy. CONCLUSIONS: The results suggest that male gender is associated with greater stated willingness to undergo biopsy. Also, the Internet is an important source of information for patients with cancer and may strongly influence their decisions about whether to consent to biopsies in early clinical trials.

Targeting the molecular chaperone heat shock protein 90 (HSP90): lessons learned and future directions.

Due to the critical role of heat shock protein 90 (HSP90) in regulating the stability, activity and intracellular sorting of its client proteins involved in multiple oncogenic processes, HSP90 inhibitors are promising therapeutic agents for cancer treatment. In cancer cells, HSP90 client proteins play a major role in oncogenic signal transduction (i.e., mutant epidermal growth factor receptor), angiogenesis (i.e., vascular endothelial growth factor), anti-apoptosis (i.e., AKT), and metastasis (i.e., matrix metalloproteinase 2 and CD91), processes central to maintaining the cancer phenotype. Thus, HSP90 has emerged as a viable target for antitumor drug development, and several HSP90 inhibitors have transitioned to clinical trials. HSP90 inhibitors include geldanamycin and its derivatives (i.e., tanespimycin, alvespimycin, IPI-504), synthetic and small molecule inhibitors (i.e., AUY922, AT13387, STA9090, MPC3100), other inhibitors of HSP90 and its isoforms (i.e., shepherdin and 5'-N-ethylcarboxamideadenosine). With more than 200 "client" proteins, many of them meta-stable and oncogenic, HSP90 inhibition can affect an array of tumors. Here we review the molecular structure of HSP90, structural features of HSP90 inhibition, pharmacodynamic effects and tumor responses in clinical trials of HSP90 inhibitors. We also discuss lessons learned from completed clinical trials of HSP90 inhibitors, and future directions for these promising therapeutic agents.