Overt hepatic encephalopathy: development of a novel clinician reported outcome tool and electronic caregiver diary.

Clinical management and clinical trials of patients with overt hepatic encephalopathy (OHE) are compromised by lack of standardized and reproducible tools for its clinical diagnosis or for caregiver (CG) identification of OHE manifestations which merit medical evaluation. Using an iterative Delphi method, Steering Committee and international hepatologist panel, the West Haven (WH) scale was modified to develop and operationalize a clinician tool for OHE identification and grading (HE Grading Instrument, HEGI™). Major diagnostic criteria included disorientation to time, place, and person, asterixis, lethargy, and coma. Minimum HEGI requirements for OHE diagnosis included: (1) disorientation, or (2) presence of both lethargy and asterixis, or (3) coma. Inter- and intra-rater HEGI reproducibility were 97 % and 98 %, respectively. When applied to a phase II clinical trial population of 178 patients with 388 OHE episodes, HEGI demonstrated excellent concordance with investigator judgement. Additionally, a multi-stage study was conducted to develop a daily CG e-diary, based on OHE manifestations recognizable by CG including speech difficulties, unusual behavior, forgetfulness, confusion, disorientation and level of consciousness. The e-diary was designed for use on smart phone, laptop or desktop, utilized branching logic and skip patterns, incorporated automatic daily completion reminders and real time alerts to clinical sites to facilitate daily standardized CG input and was found to be user friendly and understandable. The HEGI and e-diary, which were developed using methodology accepted by regulatory authorities, are designed to facilitate the design and interpretation of clinical trials for OHE and improve outcomes for OHE patients in clinical practice.

The impact of opioid-induced constipation among chronic pain patients with sufficient laxative use.

BACKGROUND: The impact of sufficient laxative use on opioid-induced constipation (OIC) is not known. AIM: To understand the experience and symptom burden over time among chronic non-cancer pain patients with OIC who are sufficient laxative users. METHODS: A prospective longitudinal study was conducted in United States, Canada, Germany and UK which included medical record abstraction, patient surveys and physician surveys. Patients on daily opioid therapy for ≥ 4 weeks for chronic non-cancer pain with OIC were recruited from physician offices and completed the survey at Baseline and Weeks 2, 4, 6, 8, 12, 16, 20 and 24. Sufficient laxative use was defined as at least one laxative remedy 4 or more times in the prior 2 weeks. RESULTS: Of the 489 patients who completed the Baseline survey and met OIC criteria, 234 (48%) were categorised as sufficient laxative users; 65% were female; 90% were white and 75 (32%) maintained sufficient laxative use for > 7 of the 8 follow-up periods. Patient Assessment of Constipation-Symptom (PAC-SYM) and Patient Assessment of Constipation-Quality of Life (PAC-QOL) scores indicated moderate symptom severity and impact. PAC-SYM and PAC-QOL scores remained relatively unchanged over time with a maximum score change of 0.5 points. Work productivity and activity impairment remained relatively constant. Mean per cent activity impairment because of constipation was 37% at Baseline and 34% at Week 24. CONCLUSIONS: These findings demonstrate constipation persists despite sufficient laxative use with little improvement in symptoms, HRQL or activity impairment. This ongoing burden emphasises the need to identify more efficacious constipation therapies for this chronic pain patient population.

Ex vivo validation of 45 MHz intravascular ultrasound backscatter tissue characterization.

AIMS: The objectives of the present study are to describe the algorithm for VH(®) IVUS using the 45-MHz rotational IVUS catheter and the associated ex vivo validation in comparison to the gold standard histology. METHODS AND RESULTS: The first phase of the present study was to construct the 45 MHz VH IVUS algorithm by using a total of 55 human coronary artery specimens [111 independent coronary lesions and 510 homogenous regions of interest (ROIs)], obtained at autopsy. Regions were selected from histology and matched with their corresponding IVUS data to build the plaque classification system using spectral analysis and statistical random forests. In the second phase, the ex vivo validation of the VH IVUS algorithm assessed a total of 1060 ROIs (120 lesions from 60 coronary arteries) in comparison with histology. In an independent manner, two interventional cardiologists also classified a randomly selected subset of the ROIs for assessment of inter- and intra-observer reproducibility of VH IVUS image interpretation.When including all ROIs, the predictive accuracies were 90.8% for fibrous tissue, 85.8% for fibro fatty tissue, 88.3% for necrotic core, and 88.0% for dense calcium. The exclusion of ROIs in the acoustically attenuated areas improved the predictive accuracies, ranging from 91.9 to 96.8%. The independent analysis of randomly selected 253 ROIs showed substantial agreement for inter-observer (k = 0.66) and intra-observer (k = 0.88) reproducibility. CONCLUSION: Tissue classification by 45 MHz VH IVUS technology, when not influenced by calcium-induced acoustic attenuation, provided combined tissue accuracy >88% to identify tissue types compared with the gold standard histologic assessment, with high inter- and intra-observer reproducibility.

Dynamic nature of nonculprit coronary artery lesion morphology in STEMI: a serial IVUS analysis from the HORIZONS-AMI trial.

OBJECTIVES: The authors sought to report the temporal stability of an untreated, nonculprit lesion phenotype in patients presenting with ST-segment elevation myocardial infarction (STEMI). BACKGROUND: The temporal stability of the untreated, nonculprit lesion phenotype has been studied using intravascular ultrasound-virtual histology (IVUS) in patients with stable ischemic heart disease, but not in STEMI patients. METHODS: As part of a formal substudy of the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) trial, baseline and 13-month follow-up IVUS was performed in 99 untreated nonculprit lesions in 63 STEMI patients. Lesions were classified as pathological intimal thickening (PIT), IVUS-derived thin-cap fibroatheroma (TCFA), thick-cap fibroatheroma (ThCFA), fibrotic plaque, or fibrocalcific plaque. RESULTS: The frequency of TCFA increased from 41% at baseline to 54% at follow-up, whereas ThCFAs decreased from 41% to 34% and PIT decreased from 16% to 8%. Among the 41 lesions classified at baseline as TCFA, at follow-up, 32 (78%) were still classified as TCFA, whereas 9 (22%) were classified as ThCFAs or fibrotic plaques. An additional 21 lesions at follow-up were newly classified as TCFA, developing from either PIT or ThCFA. TCFA at baseline that evolved into non-TCFAs trended toward a more distal location than TCFA that did not change (p = 0.12). In lesions classified as TCFA, the minimum lumen area (MLA) decreased from 8.1 (interquartile range [IQR]: 7.4 to 8.8) mm(2) at baseline to 7.8 (IQR: 7.2 to 8.4) mm(2) at follow-up, p < 0.05; this was associated with an increase in percent necrotic core at the MLA site (14% [IQR: 12 to 16] to 19% [IQR: 17 to 22], p < 0.0001) and over the entire length of the lesion (14% [IQR: 12 to 16] to 18% [IQR: 17 to 20], p < 0.0001). CONCLUSIONS: Untreated nonculprit lesions in STEMI patients frequently have TCFA morphology that does not change during 13-month follow-up and is accompanied by a decrease in MLA and an increase in necrotic core. (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction [HORIZONS-AMI]; NCT00433966).

Relation between angiographic lesion severity, vulnerable plaque morphology and future adverse cardiac events (from the Providing Regional Observations to Study Predictors of Events in the Coronary Tree study).

Previous angiographic studies have suggested that the future risk for major adverse cardiovascular events (MACEs) is related to coronary stenosis severity. The aim of this study was to use the grayscale and virtual histology (VH)-intravascular ultrasound (IVUS) data from the Providing Regional Observations to Study Predictors of Events in the Coronary Tree (PROSPECT) study to identify underlying lesion morphologic characteristics that might explain these findings. In PROSPECT, patients presenting with acute coronary syndromes in whom percutaneous coronary intervention was successful underwent 3-vessel grayscale and VH-IVUS and were followed for a median of 3.4 years for the incidence of MACEs. Overall, 3,115 nonculprit lesions detected by IVUS were divided into quartiles according to baseline angiographic diameter stenosis. From the first to fourth quartiles, there were increases in the prevalence of lesions with IVUS minimum luminal areas ≤ 4 mm(2), IVUS plaque burden ≥ 70%, and VH-IVUS thin-cap fibroatheroma (13.4%, 22.0%, 24.2%, and 30.3%, respectively, p <0.001), along with an increased frequency of plaque ruptures and greater necrotic core volumes. The incidence of lesions with plaque burden ≥ 70%, minimum luminal area ≤ 4 mm(2), and VH thin-cap fibroatheroma was highest in the fourth quartile (0%, 0.4%, 0.4%, and 2.8% in the first through fourth quartiles, respectively, p <0.001). Three-year MACE rates were also highest in the fourth quartile (0.3%, 0.7%, 1.3%, and 5.1%, respectively, p <0.001). In conclusion, increasing angiographic diameter stenosis was associated with an increased frequency of grayscale and VH-IVUS lesion morphologic features that have been associated with adverse events and that may, in part, explain why future MACEs were related to baseline lesion severity.

Validation of a 3-item OAB awareness tool.

AIM: The purpose of this study was to validate a short awareness tool to assist patients in identifying if they have bothersome overactive bladder (OAB) symptoms. METHODS: This secondary analysis study utilised data from a cross-sectional study of adult patients presenting for primary care visits. Patients completed an 8-item OAB screener. The clinician probed for urinary frequency, urgency, nocturia and urgency urinary incontinence. If the patient screened positive or reported the presence of at least one OAB symptom, additional questions were asked regarding lifestyle and coping issues. The clinician then diagnosed the patient as having No OAB, Possible OAB, or Probable OAB. Multivariate logistic regressions were performed to assess the feasibility of deriving a shorter screener to raise awareness of OAB among primary care patients. RESULTS: The 1,260 patients in this study were 51.6±17.0 years old; 62% were women; and most (89%) were Caucasian. Clinicians diagnosed 12.1% of patients with Probable OAB, 19.7% with Possible OAB and 68.3% with No OAB. The logistic regression models were performed with OAB clinical diagnosis as the dependent variable comparing No OAB versus Probable OAB. Three items which included the symptoms of urinary frequency, urinary urgency and urine loss associated with a strong desire to urinate performed well as an awareness tool. A cut-point of four provided the most appropriate sensitivity (82%) and specificity (91%) when identifying Probable OAB and yielded adequate model fit. The final 3-item OAB Awareness Tool (OAB-V3) is gender neutral. CONCLUSION: The 3-item OAB Awareness Tool (OAB-V3) correctly identified patients with symptoms of OAB with high sensitivity and specificity and can be used as a conversation starter for patients with symptoms of OAB.

The dynamic nature of coronary artery lesion morphology assessed by serial virtual histology intravascular ultrasound tissue characterization.

OBJECTIVES: We used virtual histology intravascular ultrasound (VH-IVUS) to investigate the natural history of coronary artery lesion morphology. BACKGROUND: Plaque stability is related to its histological composition. METHODS: We performed serial (baseline and 12-month follow-up) VH-IVUS studies and examined 216 nonculprit lesions (plaque burden >or=40%) in 99 patients. Lesions were classified into pathological intimal thickening (PIT), VH-IVUS-derived thin-capped fibroatheroma (VH-TCFA), thick-capped fibroatheroma (ThCFA), fibrotic plaque, and fibrocalcific plaque. RESULTS: At baseline, 20 lesions were VH-TCFAs; during follow-up, 15 (75%) VH-TCFAs "healed," 13 became ThCFAs, 2 became fibrotic plaque, and 5 (25%) VH-TCFAs remained unchanged. Compared with VH-TCFAs that healed, VH-TCFAs that remained VH-TCFAs located more proximally (values are median [interquartile range]) (16 mm [15 to 18 mm] vs. 31 mm [22 to 47 mm], p = 0.013) and had larger lumen (9.1 mm(2) [8.2 to 10.7 mm(2)] vs. 6.9 mm(2) [6.0 to 8.2 mm(2)], p = 0.021), vessel (18.7 mm(2) [17.3 to 28.6 mm(2)] vs. 15.5 mm(2) [13.3 to 16.6 mm(2)]; p = 0.010), and plaque (9.7 mm(2) [9.6 to 15.7 mm(2)] vs. 8.4 mm(2) [7 to 9.7 mm(2)], p = 0.027) areas; however, baseline VH-IVUS plaque composition did not differ between VH-TCFAs that healed and VH-TCFAs that remained VH-TCFAs. Conversely, 12 new VH-TCFAs developed; 6 late-developing VH-TCFAs were PITs, and 6 were ThCFAs at baseline. In addition, plaque area at minimum lumen sites increased significantly in PITs (7.8 mm(2) [6.2 to 10.0 mm(2)] to 9.0 mm(2) [6.5 to 12.0 mm(2)], p < 0.001), VH-TCFAs (8.6 mm(2) [7.3 to 9.9 mm(2)] to 9.5 mm(2) [7.8 to 10.8 mm(2)], p = 0.024), and ThCFAs (8.6 mm(2) [6.8 to 10.2 mm(2)] to 8.8 mm(2) [7.1 to 11.4 mm(2)], p < 0.001) with a corresponding decrease lumen areas, but not in fibrous or fibrocalcific plaque. CONCLUSIONS: Most VH-TCFAs healed during 12-month follow-up, whereas new VH-TCFAs also developed. PITs, VH-TCFAs, and ThCFAs showed significant plaque progression compared with fibrous and fibrocalcific plaque.

Analysis of the long-term effects of drug-eluting stents on coronary arterial wall morphology as assessed by virtual histology intravascular ultrasound.

BACKGROUND: Animal models show impairment of arterial healing after drug-eluting stents (DES) compared with bare-metal stents (BMS). Virtual histology intravascular ultrasound (VH-IVUS) offers an opportunity to assess lesion morphology in vivo. METHODS: We used VH-IVUS in 80 patients to assess long-term (median = 10 months) native artery vascular responses after 76 implantations of DES compared with 32 BMS. The presence of "necrotic core abutting the lumen" was evaluated at baseline and follow-up. RESULTS: At baseline, necrotic core abutting the lumen through the stent struts was observed in 76% of DES and 75% of BMS. Although the percentage of necrotic core within the plaque behind the stents did not change during follow-up in DES (23% [18%, 28%] to 22% [17%, 27%], P = .57) or BMS (22% [19%, 27%] to 20% [12%, 26%], P = .29), necrotic core abutting the lumen through the stent struts decreased more in BMS (75% to 19%, P < .001) than DES (76% to 61%, P = .036) because of the lack of an overlying, protective neointima in DES-treated lesions. Furthermore, within the adjacent reference segments, the incidence of necrotic core abutting the lumen decreased in BMS-treated lesions (proximal 23% to 0%, P = .023; distal 21% to 0%, P = .023), but not in DES (proximal 22% to 17%, P = .48; distal 23% to 21%, P = .82). CONCLUSIONS: Serial VH-IVUS analysis of DES-treated lesions showed a greater frequency of unstable lesion morphometry at follow-up compared with BMS. The apparent mechanism was a suppression of the protective neointimal hyperplasia layer coupled with a lack of vulnerable plaque resolution at reference segments in DES compared with BMS.

Relation between individual plaque components and overall plaque burden in the prospective, multicenter virtual histology intravascular ultrasound registry.

The impact of total plaque burden on absolute and relative amounts of each virtual histologic (VH) intravascular ultrasound (IVUS) plaque component has yet to be studied. We analyzed gray-scale and VH-IVUS findings in the first 990 patients enrolled in the 3,000+ patient global VH-IVUS registry. Whole pullback plaque burden and absolute and relative cross-sectional areas of fibrous tissue, fibrofatty plaque, dense calcium, and necrotic core were analyzed using a linear regression statistical model. Overall, absolute cross-sectional areas of each of the 4 plaque components correlated with total plaque cross-sectional area; however, the correlation between fibrous tissue and total plaque cross-sectional area was stronger than the correlation between fibrofatty plaque, dense calcium, or necrotic core and total plaque cross-sectional area. This was also true overall for each of the subgroups analyzed (gender, age, and presence/absence of acute coronary syndromes). Slope of the regression line relating each plaque component to overall plaque mass showed that 50% of the plaque cross-sectional area increase was because of fibrous tissue with a more gradual increase in fibrofatty plaque, dense calcium, and necrotic core. However, when comparing relative amounts of each plaque component with total plaque cross-sectional area, there was no significant relation between the increase in fibrous tissue, fibrofatty plaque, dense calcium, and necrotic core and the increase in total plaque cross-sectional area. In conclusion, only the absolute area of each plaque component correlated to overall plaque area, not the relative amount of each plaque; therefore, VH-IVUS plaque component increases must be analyzed by controlling for increases in plaque mass.

Impact of gender and age on in vivo virtual histology-intravascular ultrasound imaging plaque characterization (from the global Virtual Histology Intravascular Ultrasound [VH-IVUS] registry).

Virtual histology intravascular ultrasound (VH-IVUS) analyses were performed in the first 990 patients enrolled in the 3,000+ patient global VH-IVUS Registry to assess the impact of gender and age on in vivo VH-IVUS plaque characterization. The 990 patients were divided into 3 age group terciles (<58, 58 to 68, and >68 years) and again divided according to gender. In conclusion, (1) both women and men had an increase in plaque with increasing age; (2) at any age, men had more plaque than women; (3) percentages of dense calcium and necrotic core increased with increasing patient age in both men and women; and (4) gender differences were lowest in the oldest tercile (>68 years).

Tissue characterisation using intravascular radiofrequency data analysis: recommendations for acquisition, analysis, interpretation and reporting.

This document suggests standards for the acquisition, measurement, and reporting of radiofrequency data analysis (virtual histology - VH) intravascular ultrasound (IVUS) studies. Readers should view this document as the authors' best attempt in an area of rapidly evolving investigation, an area where rigorous evidence is not yet available or widely accepted. Nevertheless, this document is based on known pathologic data as well as previously reported imaging data; where practical, this data is summarised in the current document, a document which will also include recommendations for future evolution of the technology.

Technology insight: in vivo coronary plaque classification by intravascular ultrasonography radiofrequency analysis.

Acute coronary syndromes or sudden coronary death are often the first manifestations of coronary artery disease. In the majority of patients, acute coronary syndrome events are caused by plaque rupture in flow-limiting and non-flow-limiting angiographically intermediate stenoses. Histopathologic analyses have shown that plaque composition is related to the occurrence of acute clinical events and, therefore, to the vulnerability of the plaque. The emerging importance of adaptive coronary remodeling processes, such as the compensatory enlargement of the coronary artery in response to initial lesion development, has focused our interest on the nonstenotic lesions of the coronary tree. In vivo intravascular ultrasonography can demonstrate the discrepancies between the actual extent of coronary atherosclerosis and that seen by angiographic imaging. The spectral analysis of intravascular ultrasonography derived radiofrequency data enables more precise analysis of plaque composition and type than grayscale intravascular ultrasonography.

Virtual histology intravascular ultrasound assessment of carotid artery disease: the Carotid Artery Plaque Virtual Histology Evaluation (CAPITAL) study.

PURPOSE: To determine the diagnostic accuracy of virtual histology intravascular ultrasound imaging (VH IVUS) of carotid plaque and to assess the feasibility of VH IVUS to identify plaque with embolic potential in patients undergoing carotid artery stenting (CAS). METHODS: Thirty patients (17 men; mean age 74+/-7 years) were entered nonrandomly into a single-center, prospective, 2-arm study following FDA and Institutional Review Board approval. In one arm, 15 patients underwent VH IVUS examination of carotid plaque with a cerebral protection device immediately followed by carotid endarterectomy (CEA). A comparison of "virtual" with true histology was then performed, classifying plaque type by VH IVUS and histopathology in a blinded study. In the second arm, 15 patients undergoing CAS had a preliminary VH IVUS scan performed with cerebral protection. Debris collected from the filter following stenting was examined histologically and compared with the VH IVUS data. RESULTS: The diagnostic accuracy of VH IVUS to agree with true histology in different carotid plaque types was 99.4% in thin-cap fibroatheroma, 96.1% for calcified thin-cap fibroatheroma, 85.9% in fibroatheroma, 85.5% for fibrocalcific, 83.4% in pathological intimal thickening, and 72.4% for calcified fibroatheroma. Filter debris was captured in 2 patients prior to CEA and in 4 patients undergoing CAS for restenosis; VH IVUS classification of plaque composition was consistent with the histological evaluation of filter fragments. Calcified nodules projecting into the carotid artery lumen were associated with a higher incidence of previous neurological symptoms (66.7% versus 33.3%, p<0.05), while patients on aspirin has significantly less necrotic lipid core plaque detected by VH IVUS than patients not taking aspirin (6.4%+/-4.7% versus 9.7%+/-2.8%, p<0.05). CONCLUSION: This study showed a strong correlation between VH IVUS plaque characterization and the true histological examination of the plaque following endarterectomy, particularly in "vulnerable" plaque types. The feasibility study to examine VH IVUS data and the filter debris histology in CAS patients supports a larger prospective study.

Automated coronary plaque characterisation with intravascular ultrasound backscatter: ex vivo validation.

AIMS: Atherosclerosis is considered both a systemic and focal disease. Current diagnostic tools do not allow adequate in vivo identification and characterisation of lesions. Advanced spectral analysis of IVUS backscatter has displayed the potential for real-time plaque characterisation. The aim of this study is to determine the ex vivo accuracy of automated plaque characterisation by spectral analysis of intravascular ultrasound (IVUS) backscatter. METHODS AND RESULTS: Plaques (n=184) from 51 coronary arteries were imaged by IVUS. The arteries were then pressure fixed and matching histology collected. Regions were selected from histology and corresponding IVUS data were used to build the plaque classification system using spectral analysis and classi-fication trees. Tissue-maps were validated ex vivo by comparison with histology via 899 selected regions (n=94 plaques) that comprised 471 fibrous tissue (FT), 130 fibro-fatty (FF), 132 necrotic-core (NC) and 156 dense-calcium (DC) regions. The overall predictive accuracies were 93.5% for FT, 94.1% for FF, 95.8% for NC, and 96.7% for DC with sensitivities and specificities ranging from 72% to 99%. The Kappa statistic was calculated to be 0.845 indicating very high agreement with histology. CONCLUSIONS: Automated spectral analysis of IVUS backscatter provides accurate ex vivo information on plaque composition, with considerable potential for assessment of plaque vulnerability in real-time.

Biliary web--a rare cause of extrahepatic biliary obstruction.

A case of an isolated mucosal web of the common hepatic duct is presented. Such extrahepatic biliary webs are extremely rare causes of biliary obstruction, likely congenital in nature, but presenting in later life due to the initial patency of these webs in allowing bile drainage from the liver. The relevant literature is reviewed; diagnostic and therapeutic aspects are discussed.

Predicting mastery level on a large-scale standardized patient test: a comparison of case and instrument score-based models using discriminant function analysis.

Clinical skills assessments have traditionally been scored via experts' ratings of examinee performance. However, this approach to scoring may be impractical in a large-scale context due to logistical and cost considerations as well as the increased probability of rater error. The purpose of this investigation was therefore to identify, using discriminant analysis, weighted score-based models that maximize the accuracy with which mastery level can be estimated for examinees taking a nationally administered standardized patient test. Additionally, the accuracy with which the resulting classification functions can be applied to predict mastery level for a cross-validation sample of examinees was also examined. Results suggest that it might be feasible to implement an automated scoring procedure in a cost-effective manner while still retaining the important facets of the decision-making process of expert raters. Cost-benefit, test development and psychometric implications of these results are important and discussed in the full paper.

Closure of the abdominal midline fascia: meta-analysis delineates the optimal technique.

The current surgical literature has not clearly demonstrated an optimal technique for abdominal closure. Prospective randomized studies published between 1980 and 1998 were analyzed and the relevant data derived from those studies were pooled for statistical evaluation. The outcome variables of dehiscence, infection, hernia formation, suture sinus formation, and pain were studied and the probability of their occurrence in association with different techniques was calculated. In relation to the outcome features of dehiscence and infection no statistically significant difference was seen when absorbable suture material was compared with nonabsorbable material. In regard to the probability of hernia formation no statistically significant difference was seen when monofilament absorbable material was compared with nonabsorbable material. There was, however, a higher incidence of hernia formation when braided absorbable suture material was used. In addition there was a higher incidence of incision pain and suture sinus formation when nonabsorbable suture material was used. Absorbable monofilament suture material is superior to both absorbable braided and nonabsorbable suture for abdominal fascial closure. A continuous mass (all-layer) closure with absorbable monofilament suture material is the optimal technique for fascial closure after laparotomy.

The American Psychoanalytic Association: a decade of change.

The American Psychoanalytic Association in the last decade has undergone the most extensive organizational changes in its history. Efforts at inclusion, outreach, and democratization have halted a decline in candidates, active members, and cultural influence and led to a vibrant, growing organization, as new professional groups have gradually been included in the association's training programs. The goal of increasing training opportunities for minority candidates has only partially been achieved. A recent effort to offer affiliate status to psychotherapists and students has begun, though with modest results. Alliances with otherpsychoanalytic groups have led to creation of the Psychoanalytic Consortium and steady progress toward external accreditation of institutes and licensure of psychoanalysts. In the interest of unification there is a need to develop pathways of affiliation and membership for independent institutes and societies that desire to join the association. Democracy has in large measure already been enhanced at the national level. Deliberations are now transparent, and an invigorated Executive Committee willingly shares power with the Executive Council. Candidates now are deeply involved in the governance of Board and Council and their committees. But only when all members and candidates enjoy full voting rights and all members are able to serve as officers and Executive Councilors will the decades-long effort to democratize the association be concluded.