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Psychiatry and Clinical Psychopharmacology | 2017

Adverse drug reactions and causality: the Turkish version of Naranjo Adverse Drug Reactions Probability Scale

Samet Kose; Ercan Akin; Mesut Cetin

To the Editor, Early recognition of adverse drug reactions is crucial in the medication management of psychiatric disorders. Several diagnostic assessment tools have been proposed to evaluate and manage adverse drug reactions and determine the likelihood of drug involvement. The qualities required for an objective diagnostic assessment tool are reproducibility and validity. Reproducibility implies different users reaching the same ratings despite differences in time and place of administration and is important when comparing results at baseline and during or after the experimental procedure. Validity, in this context, means that the method is able to distinguish between cases who are drug-induced or related and cases who are not. Use of clinical judgement in evaluating alternative etiological explanations is also crucial. To improve objectiveness, consistency, and accuracy for the causality assessment of adverse drug reactions, several different clinical instruments have been proposed [1]. The Naranjo Adverse Drug Reactions Probability Scale (NADRPS) was developed for the assessment of adverse drug reactions [2]. The principal advantages of the Naranjo Adverse Drug Reaction scale are simplicity, not being time-consuming, and a wide range of applicability. The Naranjo criteria classify the probability that an adverse event is related to drug treatment based on a list of weighted questions, which examine factors such as the temporal association of drug administration and event occurrence, alternative causes for the event, drug levels, dose–response relationships, and previous patient experience with the medication. The adverse drug reactions are assigned to a probability category from the total score as follows: definite if the overall score is 9 or greater, probable for a score of 5‒8, possible for 1‒4, and finally unlikely if the score is 0. The weightings of criteria might differ among different adverse reactions to take into account the singularities of each therapeutic problem. The Naranjo scale asks for a confirmation of the adverse drug reaction using objective evidence. The Naranjo criteria also do not take into account any drug–drug interactions. Drugs are evaluated individually for causality, and points deducted if another factor may have resulted in the adverse event, henceforth weakening the causal association. When we review the case reports submitted to medical journals, we came to realize that a case report would most likely be rejected by the reviewers when authors stated that they did not use any objective assessment tool for adverse drug reactions. While reporting a an adverse drug reaction, clinicians should identify and record data from the patients and present this information using a structured reporting form, which includes demographic data, a detailed clinical history including underlying diseases and treatment, the presence of risk factors such as alcohol or substance use or pregnancy, temporal relationship between the administration of the suspected drug and the onset of adverse reaction, and between the withdrawal of the drug and the course of the adverse reaction, exclusion of alternative causes, and finally the outcome of the reaction. To the best of our knowledge, while the Adverse Reaction Submission Form prepared by the Turkish Pharmacovigilance Center can provide a demographic data for adverse drug reactions for the clinicians, no instruments like the NADRPS is available in Turkish. Here, we provide a Turkish version of the NADRPS, following the Brislin’s established guidelines [3]. The NADRPS has been translated into Turkish by Samet Kose, and back-translated into English by Ercan Akin, who was blinded to the original items. After establishing semantic equivalence of the NADRPS items, the content equivalence of all items was examined, and no items were excluded as being irrelevant. We encourage the application of the NADRPS in the causality assessment of any suspected drug-induced adverse reactions for case reports submitted for publication from Turkey. The NADRPS appears to be reliable and reproducible and could be of considerable clinical value in assessing complex patients in clinical practice and also in research settings. Furthermore, the scale can be useful in routine clinical practice to recall the parameters that need to be systematically addressed in cases of suspected adverse reactions so that clinical evaluation and management can be improved and become more consistent. We conclude that systematic application of the NADRPS would improve the quality of the assessment


Psychiatry and Clinical Psychopharmacology | 2017

The relationship between impulsivity and attention-deficit/hyperactivity symptoms in female patients with borderline personality disorder

Filiz Kulacaoglu; Mustafa Solmaz; Hasan Belli; Ferhat Can Ardic; Ercan Akin; Samet Kose

ABSTRACT OBJECTIVES: In this present study, we aimed to examine the relationship between impulsivity and attention-deficit/hyperactivity symptoms in female patients with borderline personality disorder (BPD) and compare these symptoms with a healthy group. METHODS: The sample of this study was composed of randomly selected 90 female patients diagnosed with BPD according to Diagnostic and Statistical Manual of Mental Disorders–Fifth Edition (DSM-5) criteria and not receiving any medical treatment during the past six months since presented to the Bagcilar Training and Research Hospital and randomly selected 90 healthy controls who were free of any psychiatric disorders. Semi-structured sociodemographic data form, Adult ADHD Self-Report Scale (ASRS-v1.1), and Barratt Impulsiveness Scale (BIS-11) were administered. RESULTS: Total BIS scores were statistically significantly correlated with total ASRS (r = .557, p < .001) and its two subscales: Inattention (r = .593, p < .001) and Hyperactivity/Impulsivity (r = .399, p < .001). The results of Chi-square test revealed a statistically significant difference in terms of being diagnosed with attention-deficit/hyperactivity disorder (ADHD) or not between patient and healthy group (χ2 = 46.667, df = 1, p = .000). Furthermore, there was a statistically significant difference between the patients and the healthy controls in terms of total BIS-11 [t(178) = 10.444, p = .000] and total ASRS [t(178) = 9.697, p = .000]. The results of hierarchical multiple regression revealed that Motor subscale scores were significantly predictive of ASRS scores [R2 = .337, F(6,82) = 5.960, p = .00]. CONCLUSIONS: In this present study, patients with BPD had higher rates of comorbid ADHD and impulsivity scores than healthy controls. ASRS scores and BIS scores were positively correlated, and motor subscale scores were significantly predictive of ASRS scores.


Psychiatry and Clinical Psychopharmacology | 2017

Reliability, validity, and factorial structure of the Turkish version of the Weight Self-Stigma Questionnaire (Turkish WSSQ)

Güzin Mukaddes Sevinçer; Aysenur Kaya; Suleyman Bozkurt; Ercan Akin; Samet Kose

ABSTRACT OBJECTIVE: The Weight Self-Stigma Questionnaire (WSSQ) is a comprehensive instrument for the assessment of weight self-stigma in obesity and has been validated in several languages. The purpose of this study was to examine the psychometric properties and validate the Turkish version of the WSSQ in a sample of severely obese patients in Turkey. METHODS: A cross-cultural adaptation of the WSSQ into Turkish was carried out, strictly according to recommended methods. The questionnaires including the Sociodemographic data form, the WSSQ, Beck Depression Inventory, Beck Anxiety Inventory, Eating Disorder Examination-Questionnaire, Rosenberg Self-esteem Scale, Dutch Eating Behavior Questionnaire Emotional Eating Subscale, and Impact of Weight on Quality of Life Questionnaire were completed by 120 consecutive severely obese patients (96 female, 24 male) in the outpatient clinics of the Department of Bariatric and Metabolic Surgery in a university setting in Turkey. All statistical analyses were performed by using SPSS version 23 for Windows. RESULTS: The Cronbach’s α (internal reliability) for the two subscales of the WSSQ-self-devaluation and fear of enacted stigma, and for the whole questionnaire (WSSQ Total) were 0.74, 0.81, and 0.83, respectively. The self-devaluation subscale, the enacted stigma subscale and the total WSSQ have a good internal consistency. Construct validity also appeared adequate as the WSSQ correlates with other measures largely in the manner we expected. Principal component factor analyses revealed a two-factor structure with an almost identical factor structure to that reported in the original study. Kaiser–Meyer–Olkin Measure of Sampling Adequacy was found to be 0.81 and Barlett’s test of Sphericity χ2 was found as 457.068 (p < .01). CONCLUSIONS: Our results suggested that Turkish WSSQ was a valid and reliable tool with a robust factorial structure to use for measuring weight-related self-stigma in clinical population in Turkey.


Psychiatry and Clinical Psychopharmacology | 2017

The relationship between childhood traumas, dissociation, and impulsivity in patients with borderline personality disorder comorbid with ADHD

Filiz Kulacaoglu; Mustafa Solmaz; Ferhat Can Ardic; Ercan Akin; Samet Kose

ABSTRACT Objective: Previous studies reported that there were significant associations between Attention-deficit/hyperactivity disorder (ADHD) and borderline personality disorder (BPD). In this study, we aimed to examine complex relationship between childhood trauma, impulsivity, dissociative symptoms, and the impact of ADHD on this relationship in a sample of patients with BPD. Methods: Our samples consisted of 165 BPD patients (128 female, 37 male) and 165 healthy subjects (128 female, 37 male) of similar age and gender. We administered the semi-structured socio-demographic data form, Adult Self-Report Scale, Barratt Impulsivity Scale (BIS-11), Childhood Trauma Questionnaire, and Dissociation Questionnaire. Results: The BPD group exhibited greater ADHD symptoms, impulsivity, childhood trauma, and dissociation compared to the healthy group. A statistically significant association was found between adult ADHD symptoms and impulsivity, childhood trauma, and dissociation scores. The logistic regression analysis indicated that gender, attentional and motor impulsiveness were the predictors of ADHD in BPD patients. Among these, gender and emotional neglect were the predictors of dissociation in BPD patients. Conclusion: Our results suggested a strong association between impulsivity, childhood trauma, dissociation, and ADHD symptoms in patients with BPD. The findings are mostly consistent with the literature. Clinicians should be aware of these symptoms among these populations to develop treatment strategies.


Psychiatry and Clinical Psychopharmacology | 2018

Relationship between temperament and character dimensions of personality and burnout and management in healthcare organization workers

Nevzat Devebakan; Onur Doğan; Vedat Ceylan; Ercan Akin; Samet Kose

ABSTRACT Objective: Although most burnout research has focused on environmental job-related correlates, it is possible that personality factors also play an important role in the development of burnout. The aim of present study is to examine the relationship between personality and burnout in healthcare workers by using Cloninger’s psychobiological model and Maslach’s three-dimensional burnout model in a healthcare worker sample in Turkey. Methods: Our samples consisted of 66 male, 14 female and totally 80 healthcare organization workers. Sociodemographic form for all the participants was completed during the interviews. The Maslach Burnout Inventory and Turkish TCI were completed by the participants. Multiple hierarchical regression analyses that determine best predictor of independent variables were performed to examine the association between the independent and dependent variables. Results: The hierarchical regression analysis has indicated that Self-Directedness was a significant predictor of depersonalization (β = −.347, R2 = .233, F = 1.878, p = .013) and Self-Transcendence and Self-Directedness were significant predictors of Personal Accomplishment (β = −.317, R2 = .176, F = 1.319, p = .029; β = −.328, R2 = .176, F = 1.319, p = .022; respectively), and Empathy and Self-Forgetfulness subscales were significant predictors of Personal Accomplishment (β = −.426, R2 = .106, F = 1.323, p = .013; β = −.400, R2 = .106, F = 1.323, p = .030; respectively). Conclusions: Our findings have shown that Self-Directedness, Empathy subscale of Cooperativeness and Self-Transcendence with its Self-Forgetfulness subscale were significant predictors of personal accomplishment dimension of burnout. Our results suggested a strong association between temperament and character dimensions of personality and burnout in healthcare workers.


Psychiatry and Clinical Psychopharmacology | 2018

Reliability, validity, and factorial structure of the Turkish version of the Empathy Quotient (Turkish EQ)

Samet Kose; Feryal Cam Celikel; Filiz Kulacaoglu; Ercan Akin; Mehmet Yalçın; Vedat Ceylan

ABSTRACT OBJECTIVES Empathy is an essential ability that allows us to tune into how others are feeling or thinking. Empathy makes it possible to resonate with others’ positive and negative feelings alike so that we can thus feel happy when we vicariously share the joy of others and we can share the experience of suffering when we empathize with someone in pain. Empathy training not only promotes prosocial behaviour, but also augments positive affect and resilience, which in turn fosters better coping with stressful situations. The Empathy Quotient (EQ) is a self-report questionnaire that was developed to measure the cognitive, affective, and behavioural aspects of empathy. Here, we aimed to examine the validity, reliability, and factor structure of the EQ in a Turkish sample. METHODS Participants were 436 mostly college students and civil servants (195 female, 241 male). Sociodemographic information, the Turkish version of the EQ, Marlowe-Crowne Social Desirability Scale (MC-SDS) 33-item full version and MC-SDS 13-item shorter versions were administered. All statistical analyses were performed by using SPSS version 23 for Windows. RESULTS EQ scores were significantly higher in female participants ( Female = 46.45, SDFemale = 0.62) compared to the male participants ( Male = 43.68, SD Male = 0.56). The Cronbach’s alpha coefficient for the scale was 0.76, Guttman’s split-half reliability coefficient was 0.61, and test–retest reliability coefficient was 0.95. A positive and statistically significant correlation was found between the Turkish EQ and MC-SDS Full version (r = 0.299, p < .01) and short form of MC-SDS (r = 0.273, p < .01). A three-factor solution that accounted for 25.28% of the variance observed. CONCLUSIONS The Turkish version of the EQ has satisfactory validity, good internal and test–retest reliability with a robust factorial structure to use in a clinical population in Turkey. Moreover, as predicted, women scores were statistically significantly higher on the EQ than men. This result was consistent with a series of earlier studies reporting gender differences (female superiority) on questionnaires that measure empathy. A better knowledge of empathy will have important implications for the examination and understanding of certain neurological and psychiatric disorders, including autism, narcissistic and antisocial personality disorders, and may also provide important clues about the relevant brain circuitry underlying empathy.


Psychiatry and Clinical Psychopharmacology | 2018

The role of affective temperaments and chronotype in pharmacotherapy response in patients with obsessive-compulsive disorder

Ayşe Sakallı Kani; Cana Aksoy Poyraz; B. Cağrı Poyraz; M. Reha Bayar; Ercan Akin; Samet Kose

ABSTRACT BACKGROUND: Comorbid mood disorders affect the prognosis of obsessive-compulsive disorder (OCD) negatively. Affective temperaments are assumed to be subsyndromal symptoms and precursors of mood disorders, but its effects on OCD outcome still remain unclear. There is a body of evidence, which supports the association between circadian rhythm disturbances and mood disorders in the literature. In contrast, there is limited data concerning the effects of chronobiological differences among the patients with OCD and OCD comorbid mood disorders. The main objective of this present study was to examine the clinical effects of affective temperaments and chronotype differences in patients with OCD. METHODS: The study participants were 76 patients with OCD, who have been under treatment at least for 12 weeks, and 55 healthy controls. The participants were administered the Yale-Brown Obsessive Compulsive Scale, Temperament Evaluation of Memphis, Pisa, Paris, and San Diego Auto-questionnaire, Morningness and Eveningness Questionnaire, Hamilton Depression Rating Scale, and Hamilton Anxiety Scale. RESULTS: OCD patients scored higher in depressive, cyclothymic, irritable, and anxious temperament scores compared to the healthy controls. There were significant differences between patients with remission and not remission in depressive, cyclothymic, irritable, and anxious temperaments. Eveningness chronotype was more frequent in OCD patients; however, the difference was not statistically significant. CONCLUSIONS: Understanding the effects of affective temperaments and chronotype differences on the outcome of patients with OCD might provide valuable insights in developing new treatment approaches especially in treatment-resistant OCD cases.


Psychiatry and Clinical Psychopharmacology | 2017

Reliability, validity, and factorial structure of the Turkish version of the Bradford Somatic Inventory (Turkish BSI-44) in a university student sample

Samet Kose; Nilufer Subasi Tekintas; Fatma Benk Durmus; Ercan Akin; Kemal Sayar

ABSTRACT Objective: Mumford and colleagues developed the Bradford Somatic Inventory (BSI) that examines the somatic symptoms of anxiety and depression, which has transcultural applications. The objective of the current study was to establish the psychometric properties and factorial validity of the Turkish version of the BSI-44 in a healthy Turkish population and obtain normative data. Methods: The study was conducted at the Marmara University School of Medicine with a sample of 201 healthy students (18–30 years old). In order to estimate the test–retest reliability of the Turkish BSI, 53 participants from the original sample were asked to fill in the questionnaire one month after the initial testing. Socio-demographic data of the participants were collected and the Turkish BSI, Somatosensory Amplification Scale (SSAS), Whiteley Index (WI-7), and somatization subscale of the Symptom Check List (SCL-90-R) scales were administered. All statistical analysis were performed by using SPSS version 23 for Windows. Results: The mean age of the study participants was 22.9 ± 1.95 years; 57.7% (n = 116) of participants were female; 42.3% (n = 85) were male. BSI scores were normally distributed. The scores of the BSI were categorized as high (>40), middle (26–40), and low (0–25); no statistically significant differences were found between males and females. The Cronbach’s alpha coefficient for the scale was 0.90 and the test–retest correlation coefficient was found to be 0.75. A positive and statistically significant correlation was found between the Turkish BSI and the WI (r = 0.38, p < .01), the SSAS (r = 0.48, p < .01) and the SCL-90-R (r = 0.79, p < .01) scales. A principal components analysis was performed on the BSI responses of the participants, which yielded 14 factors with an eigenvalue greater than one, representing 65.2% of the total variance. Conclusions: Our results suggested that the Turkish BSI was a valid and reliable tool with a robust factorial structure to use in clinical populations in Turkey.


Psychiatry and Clinical Psychopharmacology | 2017

Normative data and factorial structure of the Turkish version of the Junior Temperament and Character Inventory-Revised

Samet Kose; Feryal Cam Celikel; Ercan Akin; Cahit Kaya; Birgul Elbozan Cumurcu; Ilker Etikan; C. Robert Cloninger

ABSTRACT Objective: Junior Temperament and Character Inventory (J-TCI) was developed by Luby, Svrakic, McCallum, Przybeck, and Cloninger based on Cloninger’s biopsychosocial model to assess temperament and character dimensions in children and adolescents. Methods: The Turkish version of J-TCI-Revised (J-TCI-R) was administered to 1129 elementary and middle-school (male/female, 546/583) students. Internal consistency reliabilities were measured by Cronbach’s alpha; test–retest was assessed across one month. Results: Cronbach’s alphas for the subscales of J-TCI-R ranged from 0.60 to 0.75 for temperament and character subscales, which were comparable to US and other populations. The correlations between baseline and one month after administration of J-TCI-R were highly and statistically significant (r = 0.578–0.674 for scales and 0.366–0.582 for subscales) (n = 795). Factor analysis results using Eigenvalue greater than one rule indicated three out of four factors for temperament scales and one out of two factors for character subscales which were similar to findings from the other countries. When all of the subscales were subjected to factor analysis, four out of six factors were retained. To our knowledge, this is the first study analysing psychometric properties and factorial construct of the J-TCI-R. Conclusions: The internal reliability coefficients and test–retest indicated a good stability of scores over time and the factorial structure was consistent with Cloninger’s model of personality. The reliability and validity of the Turkish version of the TCI is therefore supported.


Psychiatry and Clinical Psychopharmacology | 2017

Normative data and factorial structure of the Turkish version of the Borderline Evaluation of Severity over Time (BEST)

Ercan Akin; Samet Kose; Vedat Ceylan; Gulizer Temel; Mehmet Hakan Turkcapar

ABSTRACT Objective: Borderline Personality Disorder is a psychiatric condition, which is characterized by unstable interpersonal relationships, fear of abandonment, difficulties in regulating emotions, feeling of emptiness, chronic dysphoria and depression, and impulsivity and increased risk-taking behaviors. In this study, we aimed to translate and establish psychometric properties and factorial validity of the Borderline Evaluation of Severity over Time (BEST) in a representative Turkish university students sample and obtain normative data for future epidemiological and clinical studies in Turkey. Methods: Participants were 306 (201 females, 105 males) college students at the Hasan Kalyoncu University in Gaziantep, Turkey. The study protocol was approved by the Ethics Committee of Hasan Kalyoncu University. Sociodemographic information of the participants was collected and Turkish version of the BEST, the Turkish version of the Borderline Personality Questionnaire (BPQ), Beck Depression Inventory (BDI), Personality Belief Questionnaire (PBQ), and State–Trait Anxiety scales were administered. All statistical analysis were performed by using SPSS version 23 for Windows. Results: The Cronbach’s alpha coefficients for the Thoughts and Feelings, Negative Behaviors and Positive Behaviors subscales were 0.80, 0.65, and 0.67, respectively. For the whole scale, Cronbach’s alpha coefficient was 0.75. The test–retest correlation coefficients for Thoughts and Feelings, Negative Behaviors and Positive Behaviors were 0.61, 0.50, and 0.51, respectively. A positive and statistically significant correlation was found between the Turkish BEST and BPQ (r = 0.337, p < .01), BDI (r = 0.460, p < .01), PBQ (r = 0.337, p < .01), State Anxiety (r = 0.351, p < .01), and Trait Anxiety (r = 0.387, p < .01) scales. A two-factor solution that accounted for 87.81% of the variance observed. The first two subscales of the BEST formed factor 1 and the last subscale formed factor 2. Conclusions: Our results suggested that Turkish BEST was a valid and reliable tool with a robust factorial structure to use in clinical population in Turkey.

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Samet Kose

Medical University of South Carolina

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Ilker Etikan

Gaziosmanpaşa University

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C. Robert Cloninger

Washington University in St. Louis

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Cahit Kaya

Southern University and A

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Mesut Cetin

Military Medical Academy

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