The linguistic validation of Russian version of Dutch four-dimensional symptoms questionnaire (4DSQ) for assessing distress, depression, anxiety and somatization in patients with borderline psychosomatic disorders.

BACKGROUND: The four-dimensional symptom questionnaire (4DSQ) is an originally Dutch self-report questionnaire that has been developed in primary care to distinguish non-specific general distress from depression, anxiety and somatization. In order to produce the appropriate translated Russian version the process of linguistic validation has been initiated. This process has been done according to the "Linguistic Validation Manual for Health Outcome Assessments" developed by MAPI institute. OBJECTIVE: To produce the appropriate Russian version of the 4DSQ that is conceptually and linguistically equivalent to the original questionnaire. METHODS: The original Dutch version of the 4DSQ was translated by one translator into Russian. The validated English version of the 4DSQ was translated by another translator into Russian without mutual consultation. The consensus version was created based on two translated versions. After that the back translation was performed to Dutch, some changes were implemented to the consensus Russian version and the second target version was developed based on these results. The second target version was sent to an appropriate group of reviewers. Based on their comments, the second target version was updated. After wards this version was tested in patients during cognitive interview. The study protocol was approved by the Independent Interdisciplinary Ethics Committee on Ethical Review for Clinical Studies, and in compliance with the Helsinki Declaration and ICH-GCP guidelines and local regulations. Enrolled patients provided written informed consent. RESULTS: After the process of forward and backward translation, consultant and developer's comments, clinicians and cognitive review the final version of Russian 4DSQ was developed for assessment of distress, depression, anxiety and somatization. CONCLUSION: The Russian 4DSQ as a result of translation procedures and cognitive interviews linguistically corresponds to the original Dutch 4DSQ and could be assessed in psychometric validation for the further using in general practice.

The association between somatization and disability in primary care patients.

BACKGROUND: Patient encounters for medically unexplained physical symptoms are common in primary health care. Somatization ('experiencing and reporting unexplained somatic symptoms') may indicate concurrent or future disability but this may also partly be caused by psychiatric disorders. The aim of this study was to examine the cross-sectional and longitudinal association between somatization and disability in primary care patients with and without anxiety or depressive disorder. METHODS: Data were obtained from 1545 primary care patients, participating in the longitudinal Netherlands Study of Depression and Anxiety (NESDA). Somatization was assessed using the somatization scale of the Four-Dimensional Symptom Questionnaire (4DSQ). Disability was determined by the WHO Disability Assessment Schedule 2.0 (WHO-DAS II). The relationships between somatization and both the total and subdomain scores of the WHO-DAS II were measured cross-sectionally and longitudinally after one year of follow-up using linear regression analysis. We examined whether anxiety or depressive disorder exerted a modifying effect on the somatization-disability association. RESULTS: Cross-sectionally and longitudinally, somatization was significantly associated with disability. Somatization accounted cross-sectionally for 41.8% of the variance in WHO-DAS disability and, longitudinally, for 31.7% of the variance in disability after one year of follow-up. The unique contribution of somatization to disability decreased to 16.7% cross-sectionally and 15.7% longitudinally, when anxiety and/or depressive disorder was added to the model. CONCLUSION: Somatization contributes to the presence of disability in primary care patients, even when the effects of baseline demographic and health characteristics and anxiety or depressive disorder are taken into account.

[The primary screening of patients with autonomic disorders in outpatient clinics in Russia (START1) using the Russian version of The Four-Dimensional Symptom Questionnaire (4DSQ)].

OBJECTIVE: To develop an effective diagnostic algorithm for detection of a mental component in the state of patients diagnosed with autonomic nervous system disorder. MATERIAL AND METHODS: In the frames of START1 epidemiological study, we examined 6633 patients with autonomic nervous system disorders (ICD-10 G.90.8 and G90.9) and somatoform disorders (F45) including 18,8% patients who got a referral to a psychiatrist. A linguistically validated Russian version of The Dutch Four-Dimensional Symptoms Questionnaire (4DSQ) was tested in domain subpopulations. RESULTS: In subpopulations of anxiety and depression, more than 26% of the patients got a referral to a psychiatrist that indirectly supported the assumption on the conformity of 4DSQ to the purposes of primary screening of four-dimensional disorders in the general population of patients with autonomic nervous system disorders. CONCLUSION: The linguistically validated Russian version of 4DSQ enabled to formalize the description of clinical profile of these patients. Cluster analysis of the results allowed to single out two superdomains by the pairwise combination somatization with distress (SDis) and anxiety with depression (ADep). The detection of superdomain SDis appears to be a population specific characteristic of autonomic nervous system disorders in the Russian Federation.

[The Four-Dimensional Symptom Questionnaire (4DSQ) to assess distress, depression, anxiety and somatization in autonomic and borderline psychosomatic disorders].

OBJECTIVE: Autonomic nervous system disorders are a frequent reason that makes patients to seek medical advice from general physicians and neurologists in outpatient clinics. The Dutch Four-Dimensional Symptoms Questionnaire (4DSQ) used for measuring distress, depression, anxiety and somatization is an adequate tool for identifying psychogenic factors for the development of autonomic disorders. An aim of the study was to localize the questionnaire to the Russian population. MATERIAL AND METHODS: The questionnaire was translated and the Russian version was subsequently psychometrically validated. The statistical analysis conducted for the verification of compatibility of the Russian version with the Dutch version was based on the survey of 243 patients. RESULTS: All elements of the Russian version measured the same parameters of the Dutch 4DSQ. Some differences were identified. CONCLUSION: The analysis has confirmed the possibility of using the questionnaire in the Russian-speaking population using higher threshold values: +2 points for distress and anxiety, +4 points for somatization.

Validation study of a distress screener.

OBJECTIVES: A 3-item screening instrument called the Distress Screener was developed for early identification of distress among employees on sick leave. The Distress Screener consists of three items obtained from the distress subscale of the four-dimensional symptom questionnaire (4DSQ). This study assessed an optimal cut-off point and validated the Distress Screener by relating it to the 4DSQ and to medical diagnoses. METHODS: 171 sick-listed employees filled in the Distress Screener and the 4DSQ (containing four subscales: distress, depression, anxiety and somatisation) and medical diagnoses were obtained from occupational physicians (OPs). The optimal cut-off point was assessed by computing sensitivity and specificity values. Validity was assessed by relating the Distress Screener score to the scores on 4DSQ subscales. In addition scores were compared to mental health medical diagnoses and the degree of similarity between two repeated measurements was obtained. RESULTS: Using the 4DSQ distress score >10 as reference standard, the optimal cut-off point of the Distress Screener was > or =4. Regarding validity, a high correlation (0.82) existed between the Distress Screener and the 4DSQ distress subscale and it was significantly different from the correlations with the other 4DSQ subscales. Also a high correlation existed for the test-retest reliability (0.83). Furthermore, a high score on the Distress Screener seemed to be related to the medical diagnosis 'Stress-related complaints'. All low scores seemed to be related to the medical diagnosis 'Other complaints'. Sensitivity (0.85) and specificity (0.78) values, and positive and negative predictive values of the screener were comparable to those of the 4DSQ distress subscale. CONCLUSIONS: The Distress Screener is a valid instrument for use by the OP during consulting time as a quick scan for early identification of distress in employees on sick leave. The cut-off point > or =4 is useful for early identification of distress in employees on sick leave.

[Summary of the practice guideline 'Anxiety disorders' (first revision) from the Dutch College of General Practitioners]. / Samenvatting van de standaard 'Angststoornissen' (eerste herziening) van het Nederlands Huisartsen Genootschap.

Anxiety disorders are characterised by excessive fears leading to distress or social disability. Anxiety disorders are difficult to recognise. General practitioners (GPs) should consider the possibility more often, especially in patients who make frequent visits with unexplained physical symptoms. The cornerstone of treatment is patient education, which can be supported by information leaflets provided by the Dutch College of General Practitioners. Cognitive behavioural therapy and antidepressants are equally effective therapies in most anxiety disorders. The choice should be made in collaboration with the patient. Pharmacological treatment is the first choice when a comorbid depression is involved. Cognitive behavioural therapy by the GP is optional considering the limitations of skills and time in general practice. Tricyclic antidepressants and selective serotonin re-uptake inhibitors are equally effective with most anxiety disorders. The choice must be made on the basis of side effects, comorbidity, and co-medication. Antidepressant therapy should be given for at least 6-12 months. The GP's choice oftreatment should lead to improvement within 8-12 weeks. Otherwise, consultation of or referral to a specialist in mental health care is mandatory.

[The importance of equivalence trials in showing the usefulness of treatments]. / Het belang van equivalentieonderzoek om de waarde van behandelingen aan te tonen.

There are different kinds of randomised controlled trials: trials in which the superiority of a treatment can be demonstrated (superiority trials) and trials in which the equal efficacy of two treatments can be shown (equivalence trials). The main reason for performing an equivalence trial is that for many diseases and disorders an effective treatment already exists. Equivalence trials are appropriate when a new treatment offers some advantages over an existing treatment (less cost, greater safety, improved convenience or freedom of choice for the patient), in addition to the expected equal therapeutic effectiveness. The design of equivalence trials is to a large extent comparable to that of superiority trials, but there are some methodological differences. In equivalence trials, the null hypothesis and alternative hypothesis are interchanged, compared to superiority trials. In equivalence trials, an equivalence margin is defined for the different treatments. Clinical professionals decide on the equivalence margin beforehand on the basis of the clinical relevance. To demonstrate equivalence, the confidence interval of the difference between two treatments must lie completely within the equivalence margin. In equivalence trials, there are usually more patients needed: the smaller the equivalence margin, the more patients are needed. In equivalence trials, both per-protocol analyses and intention-to-treat analyses should be used to prove the equal therapeutic effectiveness of the treatments under study.

[Characteristics of patients with the diagnosis 'mental strain' in family practice]. / Kenmerken van patiënten met de diagnose 'psychische surmenage' in de huisartspraktijk.

OBJECTIVE: To investigate the characteristics of general practitioners' patients given the diagnosis of 'surmenage' (French for 'nervous breakdown'). DESIGN: Descriptive. SETTING: General practices in Almere, the Netherlands. METHOD: Four groups of general practice attenders were selected based on the general practitioners' diagnosis: a group of surmenage patients (n = 106), a group of somatic patients without apparent psychological problems (n = 159), a group of patients with a psychosocial diagnosis (n = 136) and a group of patients with a psychiatric diagnosis (n = 57). Symptoms, social functioning, background data, life events and problems were collected by questionnaires. RESULTS: Most surmenage patients were employed young adults. They experienced more work or study related problems than the other patients. They also experienced more other problems than the somatic patients but not more than the patients with a psychosocial or psychiatric diagnosis. More than half of the surmenage patients were on sick leave. The most important symptoms in surmenage patients were nervousness, brooding, fatigue and insomnia. On the basis of their symptoms the surmenage patients could be distinguished well from the somatic and psychosocial patients, but not from the patients with a psychiatric diagnosis. The surmenage patients had a shorter duration of symptoms than the patients with a psychosocial or a psychiatric diagnosis. The group of surmenage patients was very heterogeneous. CONCLUSION: The diagnosis of surmenage is associated with nonspecific psychological symptoms, a relatively recent onset, being employed, experiencing problems related to work or study, and being on sick leave. Patients diagnosed as suffering from surmenage by their general practitioner, form a heterogeneous group.