Factor structure and psychometric properties of the german version chronic uncertainty scale (CU-20).

BACKGROUND: The experience of uncertainty is ubiquitous and universal across the globe. Many available tools measuring uncertainty are focused on one aspect of uncertainty, e.g., patients with life-threatening illnesses, hence a measure considering (chronic) uncertainty as an integral experience reflect ongoing uncertainties from a socio-cultural perspective is missing. Additionally, current tools do not account for an extended timeframe to measure chronic forms of uncertainty. The objective of this study is to validate a translated German version of the 20 item Chronic Uncertainty Scale (CU-20). METHODS: The full sample comprised N = 462 participants. Most of the participants were young German citizens and the sex distribution was relatively balanced (60% females; age in average: M = 24.56; SD = 4.78). Using equally split samples, an exploratory factor analysis (EFA) evaluated the CU-20 factor structure, followed by a confirmatory factor analysis (CFA) to test the established factor structure. Measurement invariance between male and female groups was evaluated. Internal consistency of the six-factor model was shown and scale discrimination was shown against chronic stress. RESULTS: The EFA results showed decent model fit for the five-factor structure, however based on the CFA results, the theoretically established six-factor model fits the data significantly better. Measurement invariance between male and female groups was shown to be clearly scalar invariant. Cronbach's alpha, omega and lambda all support internal consistency and reliability of CU-20. CONCLUSIONS: The CU-20 is a valid and reliable measure of one's state of chronic uncertainty reflecting the individuals' experiences of macrosocial forms of uncertainty, compared to the existing ones. This scale is especially useful in the context of migration, refugees or during global crises. Further psychometric testing is required in more diverse samples and a deeper look into measurement invariance is recommended.

Identifying Patterns of Self-Reported Nonadherence Using Network Analysis in a Mixed German Cohort.

Purpose: Nonadherence is a complex behaviour that contributes to poor health outcomes; therefore, it is necessary to understand its underlying structure. Network analysis is a novel approach to explore the relationship between multiple variables. Patients and Methods: Patients from four different studies (N = 1.746) using the self-reported Stendal Adherence to Medication Score (SAMS) were pooled. Network analysis using EBICglasso followed by confirmatory factor analysis were performed to understand how different types of nonadherence covered in the SAMS items are related to each other. Results: Network analysis revealed different categories of nonadherence: lack of knowledge about medication, forgetting to take medication, and intentional modification of medication. The intentional modification can further be sub-categorized into two groups, with one group modifying medication based on changes in health (improvement of health or adverse effects), whereas the second group adjusts medication based on overall medication beliefs and concerns. Adverse effects and taking too many medications were further identified as most influential variables in the network. Conclusion: The differentiation between modification due to health changes and modification due to overall medication beliefs is crucial for intervention studies. Network analysis is a promising tool for further exploratory studies of adherence.

A New Routine for Analyzing Brief Symptom Inventory Profiles in Chronic Pain Patients to Evaluate Psychological Comorbidity.

Question: Comorbidity, i.e., additional psychological distress in patients already suffering from chronic somatic diseases (e.g., orthopedic conditions) is of growing importance. The quality of analyzing and interpreting the often used Brief Symptom Inventory (BSI) used with orthopedic patients should improve by employing a new "case definition" of four groups (instead of two) of differentially psychologically distressed patients instead of two groups as before. Methods: Four groups with the different psychological distress definitions of "no," "mild," "remarkable," and "severe" were to be analyzed from a group of 639 orthopedic patients in inpatient rehabilitation clinics. The BSI is transformed into T values (M=50, SD=10). There is "no" distress if no T [two scales] is ≥60 and "mild" distress if T [two scales] and/or T [GSI] is ≥60 and <63. If T [two scales] and/or T [GSI] is ≥63 and <70, it is "remarkable," and if T [two scales] and/or T [GSI] ≥70, it speaks for "severe" psychological distress. Results: The new tool for analyzing psychological distress based on the T-scores of the BSI resulted in the following four groups: No psychological distress (41.9%): unspecific health-related information stands for a useful intervention. About 13.3% demonstrated low psychological distress: shorter diagnostic interviews and a few more diagnostic examinations led to a low-level outpatient group program to improve health and well-being in a preventive sense; one repeated measurement in 4weeks is advised. Remarkable psychological distress (26%): in-depth exploration using interviews, tests, and questionnaires to choose specific interventions in a single and/or group setting, outpatient or inpatient treatment; repeated measurements and process control. About 18.8% reported severe psychological distress: in-depth exploration led to specific interventions in a single and/or group setting, almost an inpatient setting; immediately crisis intervention and high-frequent process control. Conclusion: The new evaluation strategy of the BSI should improve practice and research; further investigation is necessary.

Medication Adherence and Coping with Disease in Patients from a Neurological Clinic: An Observational Study.

PURPOSE: Medication non-adherence is a huge concern for the medical community. For chronic, especially neurological diseases, taking medication is a central pillar of treatment. To improve adherence to these oftentimes complex medication regimens, the construct needs to be understood in more depth. The aim of this study was to investigate associations between adherence with sociodemographics, clinical variables, and coping in neurological patients. PATIENTS AND METHODS: The sample consisted of 545 patients from a German neurological clinic. Adherence was assessed with the Stendal Adherence to Medication Score (SAMS). Patients were grouped as completely adherent (SAMS = 0), non-adherent (upper 25% of the sample), and moderately adherent. Associations with coping were assessed using the Essen Coping Questionnaire. RESULTS: Medication adherence was low compared to other non-neurological patient samples. Differences between adherence groups were found regarding gender and facets of coping, namely "trivialisation, wishful thinking and defence" and "finding of inner stability". CONCLUSION: Interventions to improve medication adherence should focus on facets of coping with disease, increasing acceptance of disease, willpower, and confidence in treatment.

Clusters of non-adherence to medication in neurological patients.

BACKGROUND: Non-adherence to medication is a common and serious problem in health care. To develop more effective interventions to improve adherence, there is a need for a better understanding of the individual types of non-adherence. OBJECTIVE: To determine clusters of non-adherence in neurological patients using a complex adherence questionnaire. METHODS: In this observational, monocentric study 500 neurological patients (consecutive sampling) were recruited in the Department of Neurology at the Jena University Hospital, Germany (outpatient clinic, wards) over a period of 5 months. Patients with severe dementia or delirium who were unable to complete the questionnaire were excluded. Due to missing adherence data, in total, 429 patients with common neurological disorders were analyzed. Different types and clusters of non-adherence using the German Stendal Adherence to Medication Score (SAMS) were determined. RESULTS: For the 429 patients, the mean age was 63 years (SD = 16), 189 were female. According to the SAMS total score 74 (17.2%) were fully adherent, 252 (58.7%) showed moderate non-adherence and 103 (24%) showed clinically significant non-adherence. Principal component analysis with Varimax rotation revealed three independent factors explaining 60.5% of the SAMS variance. The bulk of non-adherence was attributed to modifications of medication (41.7%) and forgetting to take the medication (33.2%) followed by lack of knowledge 25.1% about reasons, dosages and time of administration for the medication. CONCLUSIONS: Intentional non-adherence was the primary self-reported behavior identified among non-adherent neurological participants. Many patients modified their prescribed medication due to various reasons, such as side effects or lacking effect. Different clusters require different interventions. While for the cluster ´forgetfulness' the reduction of poly-medication and a behavioral approach with reminders seems reasonable, patients in cluster ´missing knowledge' and cluster ´modifications' may need an educational approach.

Comparison of anonymous versus nonanonymous responses to a medication adherence questionnaire in patients with Parkinson's disease.

PURPOSE: Adherence to medication can be assessed by various self-report questionnaires. One could hypothesize that survey respondents tend to answer questions in a manner that will be viewed favorably by others. We aimed to answer if anonymous and nonanonymous responses to a questionnaire on medication adherence differ. PATIENTS AND METHODS: Adherence was assessed with the German Stendal Adherence with Medication Score (SAMS), which includes 18 questions with responses based on a 5-point Likert scale. Anonymous data from 40 subjects were collected during a symposium for patients with Parkinson's disease (PD), and nonanonymous data were obtained from 40 outpatient-clinic PD patients at the Department of Neurology. RESULTS: The two groups (anonymous self-reported questionnaire and nonanonymous) did not differ in terms of demographical characteristics and the SAMS sum score. However, anonymously collected data showed significant higher scoring for the item 6 ("Do you forget your medications?") than the data collected nonanonymously (P=0.017). All other items of the SAMS did not significantly differ between both groups. CONCLUSION: Overall assessment of adherence does not depend on whether the patient remains anonymous or not. There seems to be no relevant social desirability bias in nonanonymous responses.

Norm values and psychometric properties of the brief symptom inventory-18 regarding individuals between the ages of 60 and 95.

OBJECTIVE: The SCL-90 and the SCL-90-R are the most applied measures regarding psychological distress. To reduce and prevent an overload to of the individuals, the Brief Symptom Inventory with 18 items (BSI-18) was developed based on the SCL-90. Since psychological disorders more frequently occur at an older age, there is a growing need for efficient instruments to measure distress in the elderly. However, the BSI-18's psychometric properties, norm values, and factorial structure have not yet been investigated in this age group. METHODS: The aim of this study was to evaluate the BSI-18 in a sample of elderly people and to establish norm values for this specific population. Subsequently, demographic information and BSI-18 results were collected from a sample totaling 884 (55% female, mean age of 70.75 years, SD = 7.08, age range = 60-95 years). The questionnaire contains three six-item scales: somatization (SOMA), anxiety (ANX), and depression (DEPR), which form a general symptom index (GSI). RESULTS: We found an acceptable to good model fit for a three-factor-model with a general GSI factor. The BSI-18's psychometric properties were satisfactory. Strict measurement invariance was shown for age and gender. Additionally, we found differences in psychological distress based on sociodemographic variables. CONCLUSIONS: These findings underline the growing need for preventive mechanisms for elderly people such as, e.g., (re)activating their social networks and strengthening their physical and psychological well-being.

Development of OSTQOL: A Measure of Quality of Life for Patients in Opioid Substitution Treatment.

BACKGROUND: Quality of life (QOL) of patients in opioid substitution treatment (OST) is increasingly being addressed in research. However, no disease- or treatment-specific instrument is available to assess the QOL of this target population. The purpose of this project was to develop the first QOL instrument for OST patients. METHODS: Focus groups with 60 OST patients were analyzed using thematic analysis to elicit key QOL themes as perceived by patients. Identified themes were developed into items and refined through pilot testing and cognitive debriefing. The resulting 82 items were tested in a large sample of OST patients (n = 577). Principal component analysis with varimax rotation was performed to explore a possible factor structure and reduce the number of items. Psychometric properties were assessed. RESULTS: Factor analysis revealed 6 subscales accounting for 46.1% of the variance: Personal Development, Mental Distress, Social Contacts, Material Well-being, Opioid Substitution Treatment, and Discrimination. The 38-item instrument demonstrated good to acceptable internal consistency reliability for all subscales (Cronbach's alpha = 0.75-0.88), and good convergent and discriminant validity. CONCLUSION: The Opioid Substitution Treatment Quality of Life scale (OSTQOL) is a multidimensional instrument with low respondent and administrator burden. A thorough validation is needed to assess its validity.

[Healthy Siblings of Children with Autism Spectrum Disorders. A Mixed-methods Pilot Study]. / Gesunde Geschwister von Kindern mit Autismus-Spektrum-Störungen ­ Eine Mixed-Methods-Pilotstudie.

Healthy Siblings of Children with Autism Spectrum Disorders. A Mixed-methods Pilot Study Healthy siblings of chronically ill and/or disabled children may have an increased risk of developing behavioral problems; this is particularly given for siblings of children with Autism Spectrum Disorders (ASD). Quality of life and distress of five siblings (12-15 years) of children with ASD were examined using self- and parent-proxy-reports. Guideline-based interviews were conducted with the siblings and their parents and analyzed according to Mayring. Quality of life described by the children resembled the KINDLR´s standardized range of scores, but parents described a decreased quality of life. Both siblings and parents reported low to medium distress. Interviews revealed healthy children are asked by their parents to take responsibility for their siblings with ASD. Parents assumed their healthy children are less affected by the ASD of the sibling. The healthy siblings described being "annoyed" by ASD-associated behavior and partly feeling "treated unfairly". They wished their sibling no longer "suffered" from ASD or behaved "normally". The results of this pilot study, albeit with a small sample, show siblings do experience low to medium burden. This burden is often caused by the sibling relationship or the ASD-associated behavior. Suggestions for supporting the healthy siblings are given.

Psychometric analysis of the brief symptom inventory 18 (BSI-18) in a representative German sample.

BACKGROUND: The BSI-18 contains the three six-item scales somatization, depression, and anxiety as well as the Global Severity Index (GSI), including all 18 items. The BSI-18 is the latest and shortest of the multidimensional versions of the Symptom-Checklist 90-R, but its psychometric properties have not been sufficiently clarified yet. METHODS: Based on a representative sample of N = 2516 participants (aged 14-94 years), detailed psychometric analyses were carried out. RESULTS: The internal consistency was good: Somatization α = .82, Depression α = .87, Anxiety α = .84 and GSI α = .93. Confirmatory factor analysis supported the three scales as second-order and GSI as first-order factors. The model fit based on RMSEA is good but that model fit based on CFI and TLI are too low. CONCLUSIONS: Therefore, it is a very short, reliable instrument for the assessment of psychological distress. The BSI-18 can be used to reliably assess psychological distress in the general population. However, further studies need to evaluate the usefulness of standardization in clinical samples.

Mental distress in patients with cerebral visual injury assessed with the german brief symptom inventory.

BACKGROUND: While there are reports on vision-related quality of life in patients with vision impairment caused by both ophthalmic and brain diseases, little is known about mental distress. In fact, mental distress after cerebral visual injury has been widely ignored. METHODS: Mental health symptoms were assessed in 122 participants with visual field defects after brain damage (72 male, mean age 58.1 ± 15.6 years), who completed the German Brief Symptom Inventory (BSI) at their homes after they had been asked by phone for their participation. RESULTS: Clinically relevant mental distress was present in 25.4% of participants with cerebral visual injury. In case of multisensory impairment, an increased amount and intensity of mental distress symptoms was observed compared to the subsample with only visual impairment. CONCLUSION: Assessment of comorbid mental health symptoms appears to be clinically meaningful in brain-damaged patients with visual sensory impairment. In case of clinically relevant mental distress, psychological supportive therapies are advisable especially in subjects with cerebral visual injury and comorbidities affecting other sensory modalities as well.

[Review Model for the Assessment of Psychometric Instruments--Recommendations of the German College of Psychosomatic Medicine (DKPM)]. / Kriterienkatalog zur Beurteilung psychodiagnostischer Selbstbeurteilungsinstrumente--Empfehlung des Deutschen Kollegiums für Psychosomatische Medizin (DKPM).

OBJECTIVES: Psychometric instruments are commonly applied in psychotherapeutic research and care for the baseline assessment of symptoms, the planning of therapeutic interventions, the assessment of the longitudinal course of symptoms and outcomes of therapeutic interventions as well as quality management of care. Psychometric properties as well as economic aspects should be considered in the selection of specific instruments. It is assumed that users of psychometric instruments face a great variety of instruments and related information. For that reason, it seems challenging to absorb the current knowledge and to integrate it into clinical practice and research. Thus, it is likely that well-known, established and easily accessible instruments are commonly used, while new developed instruments might not be disseminated in research and healthcare. METHODS: Based on available international review models, the working group "Psychometrics and Psychodiagnostics" of the German College of Psychosomatic Medicine (DKPM) has developed and tested a review model specifically tailored for psychotherapeutic research and care. RESULTS: The different steps of development, as well as the final review model based on the consensus of the working group are presented. The review model contains 6 generic terms (reliability, validity, objectivity, reference groups and aspects of application) with 21 different criteria to be assessed with 0-3 asterisks (*). The criteria are clearly operationalized and the practical use of the review model is explained and discussed. CONCLUSIONS: With the review model for the assessment of psychometric instruments a well-defined evaluation system is made available for research and clinical practice which has been developed by an expert group. The review model facilitates systematic, transparent and comparative evaluation of psychometric instruments along clearly defined criteria. It also supports the selection of psychometric instruments in research and care. Next, the working group aims at disseminating and implementing the review model as well as the application and publication of reviews for different psychometric instruments based on the review model.

[The usefulness of the Brief Symptom Inventory 18 (BSI-18) in psychotherapeutic patients]. / Der Einsatz des Brief Symptom Inventory 18 (BSI-18) bei Psychotherapiepatienten.

The BSI-18, an abridged version of the Brief Symptom Inventory of Derogatis, contains the 3 six items scales Somatization, Depression, Anxiety, and the Global Score (GSI). In a sample of N=638 psychotherapeutic patients, reliability and validity were proven. Reliability of the 3 scales was good: Somatization α=0.79, Depression α=0.84, Anxiety α=0.84, and GSI α=0.91. The postulated three-factor structure was proven sufficiently using confirmatory and explorative factor analyses. The questionnaire separated different patients groups. Judgments of the therapists corresponded well with the self-rating behavior of the patients. In conclusion, the psychometric evaluation of the BSI-18 resulted in persuasive evidence for its reliability and validity. The loss of information, as a result of item reduction, is acceptable analyzing large samples; in cases of individual analyses, the SCL-90-R is advised.

From symptom relief to interpersonal change: Treatment outcome and effectiveness in inpatient psychotherapy.

This study evaluated the impact of psychodynamic inpatient psychotherapy on patients' psychological distress and interpersonal problems during the course of treatment and 1 year later. A total of 156 patients were assessed with the Symptom Checklist-90-Revised and the Inventory of Interpersonal Problems at intake, 4 weeks later, and at the end of therapy. The follow-up assessment was conducted 1 year later. Results support psychodynamic approaches as well as the phase model, which stresses that the goals to be achieved by psychotherapeutic interventions are not only improvement of well-being and symptoms but also changes in interpersonal behavior. Consequently, on a long-term basis, the first 4 weeks of therapy seem to be insufficient, especially for adequate changes on the interpersonal level.

Alexithymia and outcome in psychotherapy.

BACKGROUND: About 25% of all patients seeking psychotherapeutic treatment are considered to be alexithymic. Alexithymia has been assumed to be negatively associated with therapeutic outcome. On the other hand, it is unclear to which extent alexithymia itself may be modified by psychotherapeutic interventions. METHODS: From 414 consecutively admitted inpatients, 297 were followed up after 4 weeks (t1) and after 8-12 weeks (t2) upon discharge. Patients were treated with psychodynamic group therapy in a naturalistic setting. The Toronto Alexithymia Scale (TAS-20) and the Symptom Checklist-90 were administered. RESULTS: Twenty-seven percent of the patients were alexithymic (TAS-20 >/=61) at baseline. Multivariate models with repeated measurements indicated significant changes in Global Severity Index of the Symptom Checklist-90 in both alexithymic and nonalexithymic subjects. However, alexithymic subjects had significantly higher Global Severity Index scores than nonalexithymic subjects at t0, t1 and t2 (p < 0.001). The TAS-20 scores demonstrated a high relative stability in the total sample. However, in the alexithymic group, the TAS-20 scores changed considerably from baseline to discharge [66.3 (SD = 4.7) to 55.9 (SD = 9.9); t = 8.69; d.f. = 79; p < 0.001]. CONCLUSION: The inpatient treatment program including psychodynamic group therapy significantly reduced psychopathological distress and alexithymic features in alexithymic patients. Still, these patients suffered from higher psychopathological distress at discharge than nonalexithymics. Therefore, alexithymic features may negatively affect the long-term outcome.

The impact of living-related kidney transplantation on the donor's life.

BACKGROUND: Living-donation kidney transplantation (LDKT) is increasingly performed for treatment of chronic renal failure. Recently, risks for the donor and problems in decision-making have been stressed. This study was conducted to illuminate the decision making-process and consequences of LDKT on family life, the financial and occupational situation. Moreover, quality of life (QOL) and mental distress were explored. METHODS: All German residents at Essen University, who donated their kidney between 1999 and 2003, were included in the study. Donors filled out the questionnaire of the European Multicenter Study of Transplantation Using Living Donors, the Short Form 36-Health Survey, and the Brief Symptom Inventory. RESULTS: Out of a total of 65 donors, 47 replied (72%) at an average 2.5 years postdonation. No fatalities occurred in the whole sample (n=65), medical complications were experienced by 28%. Most donors decided voluntarily (94%) and spontaneously (66%) to donate, after donation 96% stated that they would decide in the same way again. QOL was within the norm. On the other hand, 10% experienced family conflicts, every eighth donor suffered from clinically relevant distress, financial disadvantages were experienced by every fourth donor, with 25% not answering this question. CONCLUSION: Seen from the donor's perspective, LDKT is a relatively safe procedure. However, increased rates of donors with mental distress and intra-familial conflicts emphasize the need for a careful selection process. Regular postdonation psychosocial screening and provision of specific interventions to those in need are recommended. Donors should not suffer from financial and occupational disadvantages resulting from donation.

[Rehabilitation-psychological aspects of uveitis]. / Psychosomatik der Uveitis -- eine Pilotstudie.

Until today little is known about the psychosomatic aspects of uveitis. The hypothesis that stressful life events are associated with the onset of diseases and that uveitis led to poor quality of life are discussed in the actual literature. Life events (Schedule of Recent Experiences), coping strategies (Coping Questionnaire; Essen Coping Questionnaire), psychological distress (Brief Symptom Inventory), and vision-specific quality of life (National Eye Institute Visual Functioning Questionnaire) of 51 patients with uveitis and 51 strict parallel controls were compared with another. The patients scored higher on the Schedule of Recent Experiences, lower regarding different coping strategies, and they demonstrated higher psychological distress (low effects), and they demonstrated lower disease-specific quality of life (high effect). In summary an unspecific stress hypothesis was supported; future directions of investigation were discussed.

[Does improvement of symptoms four weeks after the begin of psychodynamic inpatient psychotherapy correspond to long term outcome?]. / Entspricht die Symptombesserung vier Wochen nach Behandlungsbeginn dem Erfolg in der Ein-Jahres-Katamnese?

OBJECTIVES: This study was conducted to explore differentiated aspects of outcome throughout and one year after psychodynamic inpatient psychotherapy with special regard to symptomatic distress and interpersonal behaviour. METHODS: Sixty-four patients of the Department of Psychotherapeutic Medicine of the Jerichow Hospital (Saxonia-Anhaltina) were investigated with the SCL-90-R and the IIP-D four times: at the beginning of inpatient psychotherapy (t0), four weeks after (t1), at the end (t2), and one year after discharge (t3). RESULTS: The improvement of symptoms four weeks after the beginning of psychodynamic inpatient psychotherapy is equivalent with long term outcome. The Global Severity Index of SCL-90-R demonstrated a statistically significant change from markedly psychological distress to lack of distress after four weeks psychodynamic inpatient psychotherapy (effect-size d(GSI) = 0.82). At the end of psychotherapy, three weeks later, the effect-size was d = 1.11, and one year after discharge the effect-size decreased again to d = 0.85. Major improvements demonstrated the SCL-90-R subscales Depression, Anxiety, and Obsessive/Compulsive. Regarding interpersonal problems, the subscales Dominance, and Competitive demonstrated statistically significant changes from low Stanine-scores at t0 to higher scores one year after discharge. The subscales Socially avoidant, Nonassertive, and Exploitable demonstrated statistical significant changes from high levels at t0 to lower scores after one year. DISCUSSION: In conclusion the first four weeks of psychodynamic psychotherapy are not sufficient to demonstrate an optimum level of low psychological distress as well as an optimum change in interpersonal problems. Regarding stability of the effects of psychodynamic inpatient psychotherapy it was demonstrated that the first four weeks initiated changes which improved at the end of psychotherapy until one year after discharge.

[Symptoms and personality traits of East and West German psychotherapy patients with anxiety and depressive disorders]. / Psychometrische Merkmalsprofile von Angstpatienten und depressiven Patienten im Ost-West-Vergleich.

The aim of this study is to explore symptoms and personality traits of patients from two Psychosomatic University Departments, one in Düsseldorf (West Germany) and the other in Magdeburg (East Germany), suffering from anxiety disorders and depression. 560 unselected outpatients with anxiety disorders and depression were examined with the Symptom-Checklist (SCL-90-R) and the Inventory of Interpersonal Problems (IIP-D). The ratio of these two diagnostic groups in relation to the total number of outpatients in both clinics was analysed. The results show a higher rate of Anxiety disorders in the East German group and a higher rate of depressed patients in the West German group. Both diagnostic groups differ in certain scales of SCL-90-R and IIP-D. These profiles are mainly stable against cultural (East-West) influences. The SCL-90-R and IIP-D should be used to develop diagnostic profiles of the discussed syndromes. Social and cultural influences of patients' self ratings should be taken into account.

Clorazepate dipotassium versus midazolam for premedication in clear corneal cataract surgery.

PURPOSE: To evaluate and compare the efficacy of oral clorazepate dipotassium (Tranxilium) and intravenous midazolam (Dormicum) as premedication agents in retrobulbar anesthesia and clear corneal phacoemulsification with intraocular lens (IOL) implantation. SETTING: Department of Ophthalmology, University of Essen, Essen, Germany. METHODS: In a prospective clinical trial, 97 consecutive patients (97 eyes) having phacoemulsification with implantation of a foldable IOL were randomized to 2 groups. The first group received 10 mg oral clorazepate dipotassium and the second group, 1 mg intravenous midazolam. The surgeon's subjective experience of patients' cooperation during retrobulbar anesthesia and after surgery was measured on a 5-point Likert scale. The duration of surgery and rate of complications were documented. One day after surgery, the patients' subjective comfort during cataract surgery was evaluated using a 5-point Likert scale and the best corrected visual acuity was determined. RESULTS: The level of anterograde amnesia tended to be higher in the midazolam group than in the clorazepate dipotassium group (4% versus 0% for anesthesia administration; 14% versus 4% for surgery), but the difference between groups was not significant. There were no significant differences in patient cooperation or complications during surgery. Patient satisfaction scores were not significantly different between the groups (P<.14); however, patients in the midazolam group expected to have significantly less pain during surgery (P<.04). The rate of potential visual acuity recovery was similar between groups. CONCLUSIONS: Anterograde amnesia occurred more frequently and patients expected less pain before surgery with midazolam. Both anesthetic agents provided safe and effective premedication for retrobulbar anesthesia in clear corneal cataract surgery.