Assessing the Quality and Performance of Institutional Review Boards: Levels of Initial Reviews.

How well institutional review boards (IRBs) follow Common Rule criteria for levels of initial protocol review has not been systematically evaluated. We compared levels of review as determined using the Office for Human Research Protections (OHRP) human subject regulations decision charts of 313 protocols that had been approved by IRBs. There was a 97.8% agreement between 140 protocols that were reviewed by full board and the levels of review according to OHRP criteria. Likewise, there was a 93.8% agreement between 113 protocols that were reviewed using an expedited review procedure and OHRP criteria. However, there was only 75% agreement for exempt protocols. Specifically, 10 (16.7%) of the 60 exempt protocols were found to require IRB review, that is, six protocols requiring expedited review and four protocols requiring full board review. Conducting non-exempt research without prior IRB approval constitutes serious noncompliance. Our data suggest that exempt protocols need more scrutiny.

Time required to review research protocols at 10 Veterans Affairs Institutional Review Boards.

BACKGROUND: Despite perceptions that institutional review boards (IRBs) delay research, little is known about how long it takes to secure IRB approval. We retrospectively quantified IRB review times at 10 large Veterans Affairs (VA) IRBs. METHODS: We collected IRB records pertaining to a stratified random sample of research protocols drawn from 10 of the 26 largest VA IRBs. Two independent analysts abstracted dates from the IRB records, from which we calculated overall and incremental review times. We used multivariable linear regression to assess variation in total and incremental review times by IRB and review level (i.e., exempt, expedited, or full board) and to identify potential targets for efforts to improve the efficiency and uniformity of the IRB review process. RESULTS: In a sample of 277 protocols, the mean review time was 112 d (95% confidence interval [CI]: 105-120). Compared with full-board reviews at IRB 1, average review times at IRBs 3, 8, 9, and 10 were 27 (95% CI: 6-48), 37 (95% CI: 11-63), 45 (95% CI: 20-69), and 24 (95% CI: 2-45) d shorter, and at IRB 6, times were 56 (95% CI: 28-84) d longer. Across all IRBs, expedited reviews were 44 (95% CI: 30-58) d shorter on average than were full-board reviews, with no significant difference between exempt and full-board reviews. However, after subtracting the time required for Research and Development Committee review, exempt reviews were 21 (95% CI: 1-41) d shorter on average than were full-board reviews. CONCLUSIONS: IRB review times differ significantly by IRB and review level. Few VA IRBs approach a consensus panel goal of 60 d for IRB review. The unexpectedly longer review times for exempt protocols in the VA can be attributed to time required for Research and Development Committee review. Prospective, routine collection of key time points in the IRB review process could inform IRB-specific initiatives for reducing VA IRB review times.

Prioritizing Initiatives for Institutional Review Board (IRB) Quality Improvement.

BACKGROUND: Institutional Review Boards (IRBs) have been criticized for inconsistency, delay, and bias, suggesting an opportunity for quality improvement. To aid such quality improvement, this study aimed at determining IRB members' and investigators' priorities regarding IRB review at 10 Veterans Affairs (VA) IRBs. METHODS: 680 anonymous internet surveys were sent to 252 IRB members and staff, and 428 principal investigators and project coordinators at 9 VA Medical Centers and the VA Central IRB. Surveys included 27 statements adapted from Koocher and Kieth-Spiegel's IRB-RAT describing IRB activities or functions (e.g., "An IRB that is open to reversing its earlier decisions"). Respondents indicated how each statement described both their "ideal" and "actual" IRBs. The difference between the ratings of the actual and ideal IRBs was calculated for each item along with estimated 95% confidence intervals. Ratings outside those intervals indicated activities or functions with relatively good or poor performance compared to the ideal IRB. RESULTS: 390 (57.4%) responses from 165 IRB members and staff (65.5%) and 225 investigators and project coordinators (52.6%) demonstrated that these IRBs were closest to the ideal when protecting human subjects, treating investigators with respect, and taking appropriate action for alleged scientific misconduct. The IRBs were furthest from the ideal regarding duplicative forms, timeliness of review, and provision of complete rationales for decisions. Although IRB members reported near-ideal willingness to reverse earlier decisions, investigators rated this capacity far from ideal. Investigators rated IRB members' knowledge about procedures and policy as nearly ideal, but IRB members themselves rated this aspect far from ideal. Noteworthy site-level differences in the ratings of IRB functions and activities were also identified. CONCLUSIONS: Although these VA IRBs perform well in some areas, these data support the need for ongoing quality improvement. The described method of administering and analyzing the IRB-RAT may help identify and monitor site- and activity- specific initiatives for quality improvement.

Phenomenology of borderline personality disorder: the role of race and socioeconomic status.

Little is known about racial differences in borderline personality disorder (BPD) that may influence etiology, phenomenology, and treatment of women with BPD. A total of 83 women with BPD participated in this cross-sectional study: n = 41 white and n = 42 African-American women. Structured interviews were used to assess Axis I and II disorders, and a series of interviews and questionnaires captured internalizing and externalizing symptoms. The white women with BPD reported more severe internalizing symptoms, whereas the African-American women reported more severe externalizing symptoms. Except for the association between race and number of suicide attempts, the relationship between race and internalizing/externalizing symptoms was mediated by socioeconomic status. In conclusion, African-American women with BPD may present with more severe symptoms of lack of anger control and fewer suicidal behaviors than those of white women with BPD, raising the possibility that they are misdiagnosed and receive treatments that are not optimal for BPD.

Pregnancies, abortions, and births among women with and without borderline personality disorder.

BACKGROUND: The purpose of this study was to examine history of pregnancies among women with and without borderline personality disorder (BPD), to determine whether BPD symptoms are associated with teenage pregnancies, unplanned pregnancies, elective and spontaneous abortions, and live births. METHODS: Three hundred seventy-nine women completed the Structured Clinical Interview for DSM-IV Axis I diagnoses, Structured Interview for DSM-IV Personality for Axis II diagnoses, and a reproductive health interview. African-American (AA) women were oversampled, because little is known about BPD in AA women and they are at greater risk of teenage pregnancy, unplanned pregnancies, and spontaneous abortions. RESULTS: BPD symptom severity was associated with a teenage pregnancy, even after controlling for race and socioeconomic status. Symptom severity was also associated with unplanned pregnancies and live births, but only for women without a history of a substance use disorder. BPD symptom severity was not associated with abortion. CONCLUSION: Women with BPD become pregnant and have children, often during the period when BPD symptoms emerge and intensify. They are at increased risk of teenage pregnancies and unintended pregnancies compared with women with Axis I disorders. Treatment planning for this population should include attention to their reproductive health and better integration of physical and mental health services.

Race and sexually transmitted diseases in women with and without borderline personality disorder.

BACKGROUND: The purpose of this study was to examine the history of sexually transmitted diseases (STDs) among women with borderline personality disorder (BPD) with and without a lifetime substance use disorder (SUD) and to compare their histories to those of a group of women with a current nonpsychotic axis I disorder. METHODS: Two-hundred fifteen women completed the Structured Clinical Interview for DSM-IV Axis I diagnoses (SCID-I), Structured Interview for DSM-IV Personality for Axis II diagnoses (SIDP-IV), and a sexual health interview. African American women were oversampled because little is known about BPD in African American women and because they are at greater risk for STDs than non-African American women. RESULTS: Women with a lifetime SUD (especially cannabis use disorder) reported more STD risk factors and STDs than women without a lifetime SUD. BPD dimensional scores and African American race were predictors of STD, even after controlling for age, socioeconomic status (SES), SUDs, and participation in the sex trade. CONCLUSIONS: Determining predictors of STDs within at-risk subpopulations may help reduce the spread of STDs and prevent HIV infection within these groups by helping providers identify women at the highest risk of infection.

Interpersonal and emotional experiences of social interactions in borderline personality disorder.

UNLABELLED: GENERAL AIM: We examined interpersonal experiences of patients with borderline personality disorder (BPD) using a time-contingent diary procedure to collect information about social interactions for 7 days. METHOD: We examined the (1) quantity of social interactions and (2) interpersonal and emotional experiences during social interactions for patients with BPD (BPD; N = 42) compared with those with another personality disorder (OPD; N = 46) and those without significant personality pathology (NOPD; N = 23). RESULTS: Results suggested that BPD patients have fewer social contacts compared with those in the NOPD group. Additionally, the BPD patients characterized their social interactions as more disagreeable, ambivalent, angry, empty, and sad compared with the OPD and NOPD groups. BPD patients reported experiencing more anxiety and less positive affect compared with the NOPD but not the OPD group. CONCLUSION: These findings highlight aspects of day-to-day interpersonal functioning that are specific to BPD.

Anger, preoccupied attachment, and domain disorganization in borderline personality disorder.

Emotional dysregulation and attachment insecurity have been reported in borderline personality disorder (BPD). Domain disorganization, evidenced in poor regulation of emotions and behaviors in relation to the demands of different social domains, may be a distinguishing feature of BPD. Understanding the interplay between these factors may be critical for identifying interacting processes in BPD and potential subtypes of BPD. Therefore, we examined the joint and interactive effects of anger, preoccupied attachment, and domain disorganization on BPD traits in a clinical sample of 128 psychiatric patients. The results suggest that these factors contribute to BPD both independently and in interaction, even when controlling for other personality disorder traits and Axis I symptoms. In regression analyses, the interaction between anger and domain disorganization predicted BPD traits. In recursive partitioning analyses, two possible paths to BPD were identified: high anger combined with high domain disorganization and low anger combined with preoccupied attachment. These results may suggest possible subtypes of BPD or possible mechanisms by which BPD traits are established and maintained.

Mediators of the relationship between childhood sexual abuse and suicidal behavior in borderline personality disorder.

A history of childhood sexual abuse (CSA) increases the risk of suicidal behavior and the lifetime number of suicide attempts in adults with BPD. Despite a strong association, specific variables mediating the relationship between CSA and adult suicidal behavior in BPD have not been identified. This study examined risk factors for suicidal behavior as potential mediators of the relationship between CSA and suicide attempts in 151 men and women with BPD. Diagnostic, clinical, and psychosocial risk factors, as well as CSA, and suicidal behaviors, were assessed by standardized interviews or self-rated measures. Psychotic and schizotypal symptoms, and poor social adjustment, were associated with both CSA and suicidal behavior, and partially mediated the relationship between CSA and attempter status. Psychotic and schizotypal symptoms in BPD define a vulnerability to cognitive and perceptual distortions under stress. They increase the likelihood of suicidal behavior in BPD, especially in the absence of mitigating social support. A theoretical model for suicidal behavior in BPD is presented which integrates direct, mediated, and moderated pathways between childhood sexual abuse and temperament, adolescent and adult risk factors, and suicidal behavior.

Peer environment mediates parental history and individual risk in the etiology of cannabis use disorder in boys: a 10-year prospective study.

Previous research has shown that a trait termed neurobehavior disinhibition (ND) measured in childhood predicts substance use disorder by young adulthood. The present investigation extends these findings by determining the degree to which peer environment mediates the association between ND and development of cannabis use disorder (CUD). ND was measured in a sample of 216 boys 10-12 years of age. The peer environment was assessed at age 16. Current CUD was determined at age 22. Paternal and maternal SUD predicted son's ND which, in turn, predicted son's peer environment and, subsequently, son's cannabis use frequency and CUD. Peer environment mediated the association between ND and cannabis use and ND and CUD. Maternal and paternal SUD predicted the peer environment. Parental SUD, son's ND, and son's peer environment predicted CUD at age 22 with 84% accuracy.

Treating low-income and minority women with posttraumatic stress disorder: a pilot study comparing prolonged exposure and treatment as usual conducted by community therapists.

Twenty-one female psychiatric outpatients with chronic posttraumatic stress disorder (PTSD) are randomly assigned to prolonged exposure (PE; n = 9) for PTSD or treatment as usual (TAU; n = 12). Participants are predominantly low income and African American with complex trauma and psychiatric histories. Treatment is delivered by community therapists with no prior training in behavior therapy for anxiety disorders. Clients who completed PE show a greater improvement in PTSD symptoms, general anxiety, and depression than clients who completed TAU. These findings provide preliminary evidence suggesting that PE is an effective treatment for core PTSD symptoms, even when delivered by community therapists in a front-line services clinic.

Assessment of risk for substance use disorder consequent to consumption of illegal drugs: psychometric validation of the neurobehavior disinhibition trait.

Previous research has shown that the trait neurobehavior disinhibition (ND), which consists of affect, behavior, and cognitive indicators of self-regulation, is a significant predictor of substance use disorder (SUD) between childhood and young adulthood. The authors evaluated the psychometric properties of the ND trait in 278 boys evaluated at ages 10-12 and 16 years. ND score significantly predicted SUD and outcomes that commonly manifest in tandem with SUD by age 19, such as violence, arrests, committing crime while intoxicated, and concussion injury. In addition to predictive validity, the ND trait was found to have good construct, discriminative, and concurrent validity, as well as good test-retest and internal reliability. The ND trait may be useful for detecting youths at high risk for developing SUD and related outcomes.

Reciprocal influence of parent discipline and child's behavior on risk for substance use disorder: a nine-year prospective study.

AIM: This study aimed at determining the association of father's and mother's (parental) substance use disorder (SUD) and discipline styles and son's neurobehavior disinhibition (ND) with son's SUD from childhood (age 10-12) to young adulthood (age 19). It was hypothesized that (1) parental discipline styles and son's ND mediate the association between parental SUD and son's SUD, (2) son's ND mediates the association between parental discipline styles and son's SUD, and (3) parental discipline styles mediate the association between ND and SUD in the son. METHODS: Two-hundred-sixty-three families including a 10-12 year-old son and both parents participated in the study. RESULTS: (1) mother's discipline styles predicted father's discipline styles, (2) son's ND predicted mother's instilling guilt positively and father's punishment negatively, (3) son's ND mediated the association between father's SUD and punishment and son's SUD, and (4) mother's SUD predicted son's ND and SUD. CONCLUSIONS: The reciprocal prediction between son's ND and father's punishment and prediction of father's punishment by mother's punishment point to the need for family-based interventions that take into account the quality of specific dyadic interactions pertaining to discipline behaviors that amplify the risk for SUD in male children.

An application of item response theory to the DSM-III-R criteria for borderline personality disorder.

This paper summarizes results from analyses of the DSM criteria for borderline personality disorder (BPD) using models from item response theory (IRT). The study sample consisted of 353 participants, the majority of whom were psychiatric patients. Confirmatory factor analysis showed that a one-factor model provided the best fit to the data. All the DSM BPD criteria had moderate or higher item discrimination parameters, indicating that all items contributed meaningful information in assessing BPD. Item information functions revealed that the BPD criteria as a whole were useful for capturing BPD traits in the moderately severe to severe range, but that they performed less well in the less severe range. The general conclusion is that the criteria do represent a coherent syndrome and that further research on the informational value of the individual criteria would be useful.

Modeling the pathways linking childhood hyperactivity and substance use disorder in young adulthood.

This study modeled direct and mediated pathways linking childhood hyperactivity and substance use disorder (SUD). Boys (n = 112) were administered the revised Drug Use Screening Inventory at age 12-14 years and the Structured Clinical Interview for DSM-IV at age 22 years. Six newly derived scales having established heritability were conceptually organized into internalizing and externalizing pathways to SUD emanating from childhood hyperactivity. Hyperactivity directly predicts SUD. Neuroticism, conduct problems, and their respective manifestations of social withdrawal and school problems mediated the association between hyperactivity and SUD. Hyperactivity also predicted neuroticism that, in turn, predicted low self-esteem leading to social withdrawal and SUD. These results indicate that hyperactivity is a diathesis for both internalizing and externalizing disturbances that, in turn, portend differential expression of psychosocial maladjustment presaging SUD.

Borderline personality and substance use in women.

The association between borderline personality disorder (BPD) and substance use disorder (SUD) was examined in a predominantly psychiatric (77.6%) sample of 232 women. BPD proved to be a significant predictor of a lifetime diagnosis of SUD across four different categories: any SUD (including alcohol); alcohol use; drug use; and heroin, cocaine, or poly-substance use. BPD continued to be a predictor of SUD even when the effects of other cluster B and all cluster C PDs were controlled statistically. Antisocial personality disorder generally yielded larger odds ratios than BPD and emerged as a partial mediator of the relation between BPD and SUD. Histrionic PD was the only other PD that showed meaningful relations with SUD.

Clinical outcome of ECT in patients with major depression and comorbid borderline personality disorder.

OBJECTIVE: Previous research suggests that the comorbidity of major depression with a personality disorder, especially borderline personality disorder, is associated with a poorer response to ECT. The authors compared the acute outcome of ECT in depressed patients with borderline personality disorder, with personality disorders other than borderline personality disorder, and with no personality disorder. METHOD: The study subjects were 139 patients with a primary diagnosis of unipolar major depression and scores of at least 20 on the 24-item Hamilton Depression Rating Scale. Patients were treated with suprathreshold right unilateral or bilateral ECT in a standardized manner and were assessed with the Hamilton depression scale within 3 days and 4-8 days after completing ECT. RESULTS: Compared to patients with personality disorders other than borderline personality disorder (N=42) and those with no personality disorder (N=77), patients with borderline personality disorder (N=20) had less symptomatic improvement assessed up to 8 days after ECT. Patients with personality disorders other than borderline personality disorder responded as well to ECT as those with no personality disorder. Borderline personality disorder patients were more likely to be female and to have medication-resistant depression than the patients in the two comparison groups; they were also younger. However, none of these differences accounted for the borderline personality disorder patients' poorer response to ECT. CONCLUSIONS: Patients with borderline personality disorder have a poorer acute response to ECT, but explanations for this finding remain elusive.