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1.
Article in English | MEDLINE | ID: mdl-38795241

ABSTRACT

The error-related negativity (ERN) and error positivity (Pe) are components of the event-related potential following an error that are potential mechanistic biomarkers of obsessive-compulsive disorder (OCD). The study examined the ERN, Pe, flanker task accuracy, and clinical measures in 105 OCD cases and 105 matched healthy controls (HC) ages 8-18 years. Higher flanker task accuracy in all participants was associated with an increased ERN amplitude and increased difference between Pe and correct positivity amplitudes (ΔPe). Compared to HC, OCD cases had an increased ERN but decreased ΔPe and flanker task accuracy. Those differences were also significant in tic-related and non-tic-related OCD cases compared to HC. A lower ΔPe was associated in cases with an earlier age at OCD symptom onset. The results support the hypothesis that OCD involves defects in an error monitoring system and suggest a reduced ΔPe may compromise error signaling and cause uncertainty about the correctness of a response.

2.
Res Sq ; 2024 Feb 13.
Article in English | MEDLINE | ID: mdl-38410467

ABSTRACT

The error-related negativity (ERN) and error positivity (Pe) are components of the event-related potential following an error that are potential mechanistic biomarkers of obsessive-compulsive disorder (OCD). The study examined the ERN, Pe, flanker task accuracy, and clinical measures in 105 OCD cases and 105 matched healthy controls (HC), ages 8 to 18 years, with 21 cases having a tic disorder history. Higher flanker task accuracy in all participants was associated with an increased ERN amplitude and increased difference between Pe and correct positivity amplitudes (ΔPe). Compared to HC, OCD cases had an increased ERN but decreased flanker task accuracy and ΔPe. Those differences were also significant in tic-related and non-tic-related OCD cases compared to HC. A lower ΔPe was associated in OCD cases with an earlier age at OCD symptom onset. The results support the hypothesis that OCD involves defects in an error monitoring system and suggest a reduced ΔPe may compromise error signaling and cause uncertainty about the correctness of a response.

3.
Surg Neurol Int ; 14: 411, 2023.
Article in English | MEDLINE | ID: mdl-38213422

ABSTRACT

Background: The median nerve anatomy and its clinical presentation are crucial for surgeons to consider avoiding iatrogenic injury and performing effective surgical interventions. Case Description: An atypical presentation of median nerve anatomy proximal to the carpal tunnel was found during cadaveric dissection. The median nerve was located deep to a uniquely double-headed flexor carpi radialis and curved medially around the tendons of the forearm to enter the carpal tunnel superficially. Conclusion: The atypical presentation of median nerve anatomy can assist surgeons in adverse event reduction during surgeries such as carpal tunnel and pronator teres syndrome releases.

4.
Article in English | MEDLINE | ID: mdl-35162395

ABSTRACT

Analog space missions were created to study the human factor in extraordinary conditions that would occur in future space habitats. Isolation has been shown to cause stress and disrupt individuals' daily routine, which can also affect their oral hygiene and lead to an increased risk of dental caries and gingivitis. The astronauts' specific freeze-dried diet is associated with "lazy" chewing, potential dehydration and vitamin A deficiency, which may adversely affect their saliva. The aim of this study is to investigate the influence of the freeze-dried diet on selected oral hygiene indicators in analog astronauts (AA) enduring strict isolation conditions during six consecutive analog space missions at the LunAres Research Station. During the experiment the oral hygiene and gingival inflammation status measurements were conducted on the group of AAs at the beginning and at the end of each mission. Measurements included four oral hygiene indicators: API, sOHI, PI by Silness and Loe and GBI by Ainamo and Bay. Each AA's individual scores were noted and analyzed. Statistically significant reduction in the amount of plaque and intensity of gingival bleeding was observed over the course of the study, which could indicate positive results of applied oral hygiene procedures despite unfavorable dietary and stressful isolation conditions.


Subject(s)
Dental Caries , Gingivitis , Dental Caries/complications , Diet , Humans , Oral Hygiene
5.
J Anat ; 240(1): 172-181, 2022 01.
Article in English | MEDLINE | ID: mdl-34355792

ABSTRACT

Brachial plexus injury (BPI) occurs when the brachial plexus is compressed, stretched, or avulsed. Although rodents are commonly used to study BPI, these models poorly mimic human BPI due to the discrepancy in size. The objective of this study was to compare the brachial plexus between human and Wisconsin Miniature SwineTM (WMSTM ), which are approximately the weight of an average human (68-91 kg), to determine if swine would be a suitable model for studying BPI mechanisms and treatments. To analyze the gross anatomy, WMS brachial plexuses were dissected both anteriorly and posteriorly. For histological analysis, sections from various nerves of human and WMS brachial plexuses were fixed in 2.5% glutaraldehyde, and postfixed with 2% osmium tetroxide. Subsequently paraffin sections were counter-stained with Masson's Trichrome. Gross anatomy revealed that the separation into three trunks and three cords is significantly less developed in the swine than in human. In swine, it takes the form of upper, middle, and lower systems with ventral and dorsal components. Histological evaluation of selected nerves revealed differences in nerve trunk diameters and the number of myelinated axons in the two species. The WMS had significantly fewer myelinated axons than humans in median (p = 0.0049), ulnar (p = 0.0002), and musculocutaneous nerves (p = 0.0454). The higher number of myelinated axons in these nerves for humans is expected because there is a high demand of fine motor and sensory functions in the human hand. Due to the stronger shoulder girdle muscles in WMS, the WMS suprascapular and axillary nerves were larger than in human. Overall, the WMS brachial plexus is similar in size and origin to human making them a very good model to study BPI. Future studies analyzing the effects of BPI in WMS should be conducted.


Subject(s)
Brachial Plexus , Animals , Brachial Plexus/anatomy & histology , Hand , Humans , Shoulder , Swine , Swine, Miniature , Upper Extremity
6.
Int J Occup Saf Ergon ; 28(4): 2173-2182, 2022 Dec.
Article in English | MEDLINE | ID: mdl-34704533

ABSTRACT

Offshore industry has always been a risky working place, and therefore there has always been a strong focus on maintaining the highest safety standards. The present research aims to ascertain the effects of a new safety mindset from both individual employee and organizational angles, and is based on two surveys conducted in 2010 and 2014 on Danish oil production platforms in the North Sea and qualitative data from interviews, observations and documentary analysis. The participating offshore oil company introduced a new safety mindset at the beginning of 2010 to all of their employees and subcontractors. The results indicate that there were some significant, positive changes both in individual employee attitudes towards safety and in strong organizational commitment to work closely with employees to ensure the highest workplace safety status on oil platforms. However, the results also show that it is important to maintain a campaign to ensure these positive effects.


Subject(s)
Safety Management , Workplace , Humans , Follow-Up Studies , Surveys and Questionnaires , Denmark , Organizational Culture
7.
Front Cell Dev Biol ; 9: 737426, 2021.
Article in English | MEDLINE | ID: mdl-34722519

ABSTRACT

Adenosine receptors (AR) are widely expressed in a variety of tissues including the retina and brain. They are involved in adenosine-mediated immune responses underlying the onset and progression of neurodegenerative diseases. The expression of AR has been previously demonstrated in some retinal cells including endothelial cells and retinal pigment epithelial cells, but their expression in the choroid and choroidal cells remains unknown. Caffeine is a widely consumed AR antagonist that can influence inflammation and vascular cell function. It has established roles in the treatment of neonatal sleep apnea, acute migraine, and post lumbar puncture headache as well as the neurodegenerative diseases such as Parkinson and Alzheimer. More recently, AR antagonism with caffeine has been shown to protect preterm infants from ischemic retinopathy and retinal neovascularization. However, whether caffeine impacts the development and progression of ocular age-related diseases including neovascular age-related macular degermation remains unknown. Here, we examined the expression of AR in retinal and choroidal tissues and cells. We showed that antagonism of AR with caffeine or istradefylline decreased sprouting of thoracic aorta and choroid/retinal pigment epithelium explants in ex vivo cultures, consistent with caffeine's ability to inhibit endothelial cell migration in culture. In vivo studies also demonstrated the efficacy of caffeine in inhibition of choroidal neovascularization and mononuclear phagocyte recruitment to the laser lesion sites. Istradefylline, a specific AR 2A antagonist, also decreased choroidal neovascularization. Collectively, our studies demonstrate an important role for expression of AR in the choroid whose antagonism mitigate choroidal inflammatory and angiogenesis activities.

8.
J Neurosurg ; 136(3): 927-930, 2021 Oct 22.
Article in English | MEDLINE | ID: mdl-34678776
9.
Child Psychiatry Hum Dev ; 51(5): 827-838, 2020 10.
Article in English | MEDLINE | ID: mdl-32656660

ABSTRACT

The error-related negativity (ERN) is a negative deflection in the event-related potential following a mistake that is a putative biomarker of anxiety. The study assessed the ERN as a diagnostic biomarker using receiver operating characteristic (ROC) analyses in 96 cases with anxiety disorders (AD) and 96 matched healthy controls (HC) ages 8 to 18 years. Forty-one cases had generalized anxiety disorder (GAD); 55 cases had other anxiety disorders (OAD) without GAD. ERN amplitude was significantly increased in AD cases compared to HC. The area under the curve (AUC) in the ROC analysis was 0.64, indicating the ERN is an inadequate diagnostic test for AD altogether. The ERN was significantly increased in cases with either GAD or OAD compared to HC. The AUC in ROC analyses with GAD and OAD was 0.75 and 0.56, respectively, suggesting the ERN provides an adequate diagnostic test for GAD but not for OAD.


Subject(s)
Anxiety Disorders/diagnosis , Anxiety Disorders/physiopathology , Evoked Potentials/physiology , Adolescent , Biomarkers , Child , Electroencephalography , Female , Humans , Male
10.
J Brachial Plex Peripher Nerve Inj ; 15(1): e1-e4, 2020 Jan.
Article in English | MEDLINE | ID: mdl-32055253

ABSTRACT

Median nerve anatomy is of great interest to clinicians and scientists given the importance of this nerve and its association with diseases. A rare anatomical variant of the median nerve in the distal forearm and wrist was discovered during a cadaveric dissection. The median nerve was deep to the flexor digitorum superficialis (FDS) in the carpal tunnel. It underwent a 360-degree spin before emerging at the lateral edge of FDS. The recurrent motor branch moved from medial to lateral on the deep surface of the median nerve, as it approached the distal carpal tunnel. This variant doesn't fall into any of Lanz's four groups of median nerve anomalies. We propose a fifth group that involves variations in the course of the median nerve. This report underscores the importance of recognizing variants of the median nerve anatomy in the forearm and wrist during surgical interventions, such as for carpal tunnel syndrome.

11.
Brain Sci ; 10(2)2020 Feb 02.
Article in English | MEDLINE | ID: mdl-32024242

ABSTRACT

The pathophysiology of attention-deficit/hyperactivity disorder (ADHD) involves deficits in performance monitoring and adaptive adjustments. Yet, the developmental trajectory and underlying neural correlates of performance monitoring deficits in youth with ADHD remain poorly understood. To address the gap, this study recruited 77 children and adolescents with ADHD and 77 age- and gender-matched healthy controls (HC), ages 8-18 years, who performed an arrow flanker task during electroencephalogram recording. Compared to HC, participants with ADHD responded more slowly and showed larger reaction time variability (RTV) and reduced post-error slowing; they also exhibited reduced error-related negativity (ERN) and error positivity effects, and reduced N2 and P3 congruency effects. Age effects were observed across groups: with increasing age, participants responded faster, with less variability, and with increased post-error slowing. They also exhibited increased ERN effects and increased N2 and P3 congruency effects. Increased RTV and reduced P3 amplitude in incongruent trials were associated with increased ADHD Problems Scale scores on the Child Behavior Checklist across groups. The altered behavioral and ERP responses in ADHD are consistent with the pattern associated with younger age across groups. Further research with a longitudinal design may determine specific aspects of developmental alteration and deficits in ADHD during performance monitoring.

12.
Child Psychiatry Hum Dev ; 51(6): 888-899, 2020 12.
Article in English | MEDLINE | ID: mdl-32030629

ABSTRACT

The study assessed the ability of the Obsessive-Compulsive Inventory-Child Version (OCI-CV) to detect pediatric obsessive-compulsive disorder (OCD) using receiver operating characteristic analyses. The sample consisted of 114 cases with current OCD, 340 cases with other psychiatric disorders (OPD), and 301 healthy controls (HC) ages 7 to 18 years. All 755 participants were assessed with two semi-structured interviews and seven rating scales. In a comparison of current OCD cases and all other participants, the optimal OCI-CV cut-score was 11 with an area under the curve (AUC) of .88. In a comparison of current OCD cases and OPD cases, the optimal OCI-CV cut-score was 11 with an AUC of .82. In a comparison of current OCD cases and HC, the optimal OCI-CV cut-score was 10 with an AUC of .94. The results indicate that the OCI-CV provides an effective screen for pediatric OCD using empirically derived cut-scores.


Subject(s)
Mass Screening/statistics & numerical data , Obsessive-Compulsive Disorder/diagnosis , Personality Inventory/statistics & numerical data , Adolescent , Child , Diagnosis, Differential , Female , Humans , Male , Mental Disorders/diagnosis , Mental Disorders/psychology , Obsessive-Compulsive Disorder/psychology , Psychometrics/statistics & numerical data , ROC Curve , Reproducibility of Results
13.
Sci Rep ; 9(1): 9700, 2019 07 04.
Article in English | MEDLINE | ID: mdl-31273232

ABSTRACT

B-cell lymphoma 2 (Bcl-2) protein is the founding member of a group of proteins known to modulate apoptosis. Its discovery set the stage for identification of family members with either pro- or anti-apoptotic properties. Expression of Bcl-2 plays an important role during angiogenesis by influencing not only vascular cell survival, but also migration and adhesion. Although apoptosis and migration are postulated to have roles during vascular remodeling and regression, the contribution of Bcl-2 continues to emerge. We previously noted that the impaired retinal vascularization and an inability to undergo pathologic neovascularization observed in mice globally lacking Bcl-2 did not occur when mice lacked the expression of Bcl-2 only in endothelial cells. To further examine the effect of Bcl-2 expression during vascularization of the retina, we assessed its contribution in pericytes or astrocytes by generating mice with a conditional Bcl-2 allele (Bcl-2Flox/Flox) and Pdgfrb-cre (Bcl-2PC mice) or Gfap-cre (Bcl-2AC mice). Bcl-2PC and Bcl-2AC mice demonstrated increased retinal vascular cell apoptosis, reduced numbers of pericytes and endothelial cells and fewer arteries and veins in the retina. Bcl-2PC mice also demonstrated delayed advancement of the superficial retinal vascular layer and aberrant vascularization of the deep vascular plexus and central retina. Although pathologic neovascularization in oxygen-induced ischemic retinopathy (OIR) was not affected by lack of expression of Bcl-2 in either pericytes or astrocytes, laser-induced choroidal neovascularization (CNV) was significantly reduced in Bcl-2PC mice compared to littermate controls. Together these studies begin to reveal how cell autonomous modulation of apoptosis in vascular cells impacts development and homeostasis.


Subject(s)
Astrocytes/pathology , Choroidal Neovascularization/pathology , Endothelium, Vascular/pathology , Neovascularization, Pathologic/pathology , Pericytes/pathology , Proto-Oncogene Proteins c-bcl-2/physiology , Retinal Diseases/pathology , Animals , Apoptosis , Cell Proliferation , Choroidal Neovascularization/etiology , Choroidal Neovascularization/metabolism , Female , Ischemia/etiology , Ischemia/metabolism , Ischemia/pathology , Male , Mice , Mice, Knockout , Neovascularization, Pathologic/etiology , Neovascularization, Pathologic/metabolism , Oxygen/toxicity , Retinal Diseases/etiology , Retinal Diseases/metabolism , Retinal Vessels/pathology
15.
JAMA Intern Med ; 176(3): 310-8, 2016 Mar.
Article in English | MEDLINE | ID: mdl-26857383

ABSTRACT

IMPORTANCE: It remains unclear whether telemonitoring approaches provide benefits for patients with heart failure (HF) after hospitalization. OBJECTIVE: To evaluate the effectiveness of a care transition intervention using remote patient monitoring in reducing 180-day all-cause readmissions among a broad population of older adults hospitalized with HF. DESIGN, SETTING, AND PARTICIPANTS: We randomized 1437 patients hospitalized for HF between October 12, 2011, and September 30, 2013, to the intervention arm (715 patients) or to the usual care arm (722 patients) of the Better Effectiveness After Transition-Heart Failure (BEAT-HF) study and observed them for 180 days. The dates of our study analysis were March 30, 2014, to October 1, 2015. The setting was 6 academic medical centers in California. Participants were hospitalized individuals 50 years or older who received active treatment for decompensated HF. INTERVENTIONS: The intervention combined health coaching telephone calls and telemonitoring. Telemonitoring used electronic equipment that collected daily information about blood pressure, heart rate, symptoms, and weight. Centralized registered nurses conducted telemonitoring reviews, protocolized actions, and telephone calls. MAIN OUTCOMES AND MEASURES: The primary outcome was readmission for any cause within 180 days after discharge. Secondary outcomes were all-cause readmission within 30 days, all-cause mortality at 30 and 180 days, and quality of life at 30 and 180 days. RESULTS: Among 1437 participants, the median age was 73 years. Overall, 46.2% (664 of 1437) were female, and 22.0% (316 of 1437) were African American. The intervention and usual care groups did not differ significantly in readmissions for any cause 180 days after discharge, which occurred in 50.8% (363 of 715) and 49.2% (355 of 722) of patients, respectively (adjusted hazard ratio, 1.03; 95% CI, 0.88-1.20; P = .74). In secondary analyses, there were no significant differences in 30-day readmission or 180-day mortality, but there was a significant difference in 180-day quality of life between the intervention and usual care groups. No adverse events were reported. CONCLUSIONS AND RELEVANCE: Among patients hospitalized for HF, combined health coaching telephone calls and telemonitoring did not reduce 180-day readmissions. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01360203.


Subject(s)
Heart Failure , Monitoring, Physiologic , Patient Discharge , Patient Readmission/statistics & numerical data , Quality of Life , Telemetry , Telephone , Aged , Aged, 80 and over , Confounding Factors, Epidemiologic , Female , Humans , Male , Middle Aged , Monitoring, Physiologic/methods , Odds Ratio , Proportional Hazards Models , Prospective Studies , Research Design , United States/epidemiology
16.
J Occup Med Toxicol ; 9(1): 35, 2014.
Article in English | MEDLINE | ID: mdl-25349623

ABSTRACT

BACKGROUND: The aim of the study was to examine occupational accidents reported from non-passenger merchant ships registered in the Danish International Ship Register in 2010-2012, with a focus on analysing nationality differences in the risk of getting injured in an accident. METHODS: Data about notified occupational accidents were collected from notifications sent to the Danish Maritime Authority and from records of contact with Danish Radio Medical. Events were matched by personal identification and accident data to create a unified database. Stratified cumulative time spent on board by seafarers was used to calculate accident rates. Incidence rates of different nationalities were compared by Poisson regression. RESULTS: Western European seafarers had an overall accident rate of 17.5 per 100000 person-days, which proved to be significantly higher than that of Eastern European, South East Asian and Indian seaman (adjusted incidence rate ratio 0.53, 0.51 and 0.74, respectively), although differences decreased over the investigated period. Smaller but in most cases still significant discrepancies were observed for serious injuries. The back injury rate of Western European employees was found especially high, while eye injuries seem to be more frequent among South East Asian workers. CONCLUSIONS: The study identified substantial differences between nationalities in the rate of various accidents reported from merchant ships sailing under the Danish flag. The differences may be attributed to various factors such as safety behaviour. Investigation of special injury types and characterisation of effective elements of safety culture can contribute to the improvement of workplace safety in the maritime sector.

17.
Womens Health Issues ; 22(1): e9-18, 2012.
Article in English | MEDLINE | ID: mdl-21784659

ABSTRACT

PURPOSE: We examined sexual risk behaviors and unrecognized HIV infection among heterosexually active African-American and Hispanic women. METHODS: Women not previously diagnosed with HIV infection were recruited in rural counties in North Carolina (African American) and Alabama (African American), and an urban county in southern Florida (Hispanic) using multiple methods. They completed a computer-administered questionnaire and were tested for HIV infection. RESULTS: Between October 2008 and September 2009, 1,527 women (1,013 African American and 514 Hispanic) enrolled in the study. Median age was 35 years (range, 18-59), 33% were married or living as married, 50% had an annual household income of $12,000 or less, and 56% were employed full or part time. Two women (0.13%) tested positive for HIV. In the past 12 months, 19% had been diagnosed with a sexually transmitted infection (other than HIV), 87% engaged in unprotected vaginal intercourse (UVI), and 26% engaged in unprotected anal intercourse (UAI). In multivariate analysis, UAI was significantly (p < .05) more likely among those who reported ever being pregnant, binge drinking in the past 30 days, ever exchanging sex for things needed or wanted, engaging in UVI, or being of Hispanic ethnicity. UAI was also more likely to occur with partners with whom women had a current or past relationship as opposed to casual partners. CONCLUSION: A high percentage of our sample of heterosexually active women of color had recently engaged in sexual risk behaviors, particularly UAI. More research is needed to elucidate the interpersonal dynamics that may promote this high-risk behavior. Educational messages that explicitly address the risks of heterosexual anal intercourse need to be developed for heterosexually active women and their male partners.


Subject(s)
Black or African American/psychology , HIV Infections/ethnology , Hispanic or Latino/psychology , Risk-Taking , Sexually Transmitted Diseases/ethnology , Unsafe Sex/ethnology , Adolescent , Adult , Female , HIV Infections/etiology , HIV Infections/transmission , Heterosexuality , Humans , Middle Aged , Sexual Behavior/ethnology , Sexual Partners , Sexually Transmitted Diseases/etiology , Sexually Transmitted Diseases/transmission , Southeastern United States , Young Adult
18.
J Am Med Inform Assoc ; 18 Suppl 1: i24-7, 2011 Dec.
Article in English | MEDLINE | ID: mdl-21976028

ABSTRACT

The patient portal is a web service which allows patients to view their electronic health record, communicate online with their care teams, and manage healthcare appointments and medications. Despite advantages of the patient portal, registrations for portal use have often been slow. Using a secure video system on our existing exam room electronic health record displays during regular office visits, the authors showed patients a video which promoted use of the patient portal. The authors compared portal registrations and portal use following the video to providing a paper instruction sheet and to a control (no additional portal promotion). From the 12,050 office appointments examined, portal registrations within 45 days of the appointment were 11.7%, 7.1%, and 2.5% for video, paper instructions, and control respectively (p<0.0001). Within 6 months following the interventions, 3.5% in the video cohort, 1.2% in the paper, and 0.75% of the control patients demonstrated portal use by initiating portal messages to their providers (p<0.0001).


Subject(s)
Electronic Health Records , Health Records, Personal , Patient Access to Records , Patient Education as Topic , Humans , Internet , Office Visits , Video Recording
19.
Depress Anxiety ; 28(6): 501-8, 2011 Jun.
Article in English | MEDLINE | ID: mdl-21538726

ABSTRACT

OBJECTIVE: This study examined the comorbidity of obsessive-compulsive disorder (OCD) with major depressive disorder (MDD) in a family study of OCD with pediatric probands. METHOD: This study assessed the lifetime prevalence of MDD in 141 first-degree relatives (FDR) and 452 second-degree relatives (SDR) of pediatric probands with OCD and healthy controls, and identified variables associated with MDD in case FDR. All available FDR were directly interviewed blind to proband status; parents were also interviewed to assess the family psychiatric history of FDR and SDR. Best-estimate diagnoses were made using all sources of information. Data were analyzed with logistic regression and robust Cox regression models. RESULTS: Lifetime MDD prevalence was significantly higher in case than in control FDR (30.4 versus 15.4%). Lifetime MDD prevalence was significantly higher in FDR of case probands with MDD than in FDR of case probands without MDD or control FDR (46.3 versus 19.7 versus 15.4%, respectively). MDD in case FDR was significantly associated with MDD in case probands and with age and OCD in those relatives. Lifetime MDD prevalence was similar in case and control SDR. However, lifetime MDD prevalence was significantly higher in SDR of case probands with MDD than in SDR of case probands without MDD or control SDR (31.9 versus 16.8 versus 15.4%, respectively). CONCLUSIONS: MDD prevalence was significantly higher in both FDR and SDR of case probands with MDD than in relatives of case probands without MDD or control relatives, suggesting that pediatric OCD comorbid with MDD is a complex familial syndrome.


Subject(s)
Depressive Disorder, Major/genetics , Genetic Predisposition to Disease/genetics , Obsessive-Compulsive Disorder/genetics , Adolescent , Case-Control Studies , Child , Comorbidity , Cross-Sectional Studies , Depressive Disorder, Major/diagnosis , Depressive Disorder, Major/epidemiology , Depressive Disorder, Major/psychology , Female , Genetic Predisposition to Disease/psychology , Humans , Male , Obsessive-Compulsive Disorder/diagnosis , Obsessive-Compulsive Disorder/epidemiology , Obsessive-Compulsive Disorder/psychology , Personality Assessment/statistics & numerical data , Proportional Hazards Models , Psychometrics , Risk Factors
20.
J Clin Psychiatry ; 72(7): 909-13, 2011 Jul.
Article in English | MEDLINE | ID: mdl-20868637

ABSTRACT

OBJECTIVE: The pharmacokinetic profile of a drug often gives little indication of its potential therapeutic application, with many therapeutic uses of drugs being discovered serendipitously while being studied for different indications. As hypothesis-driven, quantitative research methodology is exclusively used in early-phase trials, unexpected but important phenomena may escape detection. In this context, this study aimed to examine the potential for integrating qualitative research methods with quantitative methods in early-phase drug trials. To our knowledge, this mixed methodology has not previously been applied to blinded psychopharmacologic trials. METHOD: We undertook qualitative data analysis of clinical observations on the dataset of a randomized, double-blind, placebo-controlled trial of N-acetylcysteine (NAC) in patients with DSM-IV-TR-diagnosed schizophrenia (N = 140). Textual data on all participants, deliberately collected for this purpose, were coded using NVivo 2, and emergent themes were analyzed in a blinded manner in the NAC and placebo groups. The trial was conducted from November 2002 to July 2005. RESULTS: The principal findings of the published trial could be replicated using a qualitative methodology. In addition, significant differences between NAC- and placebo-treated participants emerged for positive and affective symptoms, which had not been captured by the rating scales utilized in the quantitative trial. Qualitative data in this study subsequently led to a positive trial of NAC in bipolar disorder. CONCLUSIONS: The use of qualitative methods may yield broader data and has the potential to complement traditional quantitative methods and detect unexpected efficacy and safety signals, thereby maximizing the findings of early-phase clinical trial research. TRIAL REGISTRATION: www.anzctr.org.au Identifier: ACTRN12605000363684.


Subject(s)
Acetylcysteine/therapeutic use , Data Collection/methods , Data Collection/statistics & numerical data , Free Radical Scavengers/therapeutic use , Schizophrenia/drug therapy , Schizophrenic Psychology , Adult , Double-Blind Method , Female , Humans , Male , Middle Aged , Psychiatric Status Rating Scales , Schizophrenia/diagnosis
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