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Background Despite widespread use of learning collaboratives in health care, few randomized trials have evaluated their effectiveness. The primary aim of this cluster randomized implementation trial is to evaluate the effectiveness of a virtual learning collaborative (VLC) in the implementation of a lifestyle intervention for persons with serious mental illness (SMI) in routine mental health settings, compared to standard individual technical assistance. Methods Forty-eight mental health provider organizations from across the United States will be recruited to participate in the trial. The evidence-based practice to be implemented is the InSHAPE health promotion intervention for persons with SMI. Sites will be stratified by size and randomized to receive an 18-month intensive group-based VLC with monthly learning sessions or individual technical assistance with four scheduled conference calls over 18 months. Sites will be enrolled in three blocks of 16 sites each. The primary outcomes are InSHAPE program participation and fidelity, and participant weight loss; secondary outcomes are program operation, program uptake, participant health behaviors of physical activity and nutrition, organizational change, and program sustainment. Implementation outcomes are measured at 3, 6, 12, 18, and 24 months after the program start-up. Participant-level outcomes are measured at fixed intervals every 3 months after each participant enrolls in the study. Discussion This study will determine whether VLCs are an effective implementation strategy among resource-limited providers when the new practice necessitates a shift in mission, scope of practice, type of services delivered, and new financing. Trial registration ClinicalTrials.gov identifier: NCT03891368 Registered 25 March 2019, retrospectively registered. https://clinicaltrials.gov/ct2/show/NCT03891368?term=NCT03891368&rank=1

This manuscript represents the perspective of the Dissolution Working Group of the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) and of two focus groups of the American Association of Pharmaceutical Scientists (AAPS): Process Analytical Technology (PAT) and In Vitro Release and Dissolution Testing (IVRDT). The intent of this manuscript is to show recent progress in the field of in vitro predictive dissolution modeling and to provide recommended general approaches to developing in vitro predictive dissolution models for both early- and late-stage formulation/process development and batch release. Different modeling approaches should be used at different stages of drug development based on product and process understanding available at those stages. Two industry case studies of current approaches used for modeling tablet dissolution are presented. These include examples of predictive model use for product development within the space explored during formulation and process optimization, as well as of dissolution models as surrogate tests in a regulatory filing. A review of an industry example of developing a dissolution model for real-time release testing (RTRt) and of academic case studies of enabling dissolution RTRt by near-infrared spectroscopy (NIRS) is also provided. These demonstrate multiple approaches for developing data-rich empirical models in the context of science- and risk-based process development to predict in vitro dissolution. Recommendations of modeling best practices are made, focused primarily on immediate-release (IR) oral delivery products for new drug applications. A general roadmap is presented for implementation of dissolution modeling for enhanced product understanding, robust control strategy, batch release testing, and flexibility toward post-approval changes.

This publication summarizes the proceedings of day 3 of a 3-day workshop on "Dissolution and Translational Modeling Strategies Enabling Patient-Centric Product Development." Specifically, this publication discusses the current approaches in building clinical relevance into drug product development for solid oral dosage forms, along with challenges that both industry and regulatory agencies are facing in setting clinically relevant drug product specifications (CRDPS) as presented at the workshop. The concept of clinical relevance is a multidisciplinary effort which implies an understanding of the relationship between the critical quality attributes (CQAs) and their impact on predetermined clinical outcomes. Developing this level of understanding, in many cases, requires introducing deliberate but meaningful variations into the critical material attributes (CMAs) and critical process parameters (CPPs) to establish a relationship between the resulting in vitro dissolution/release profiles and in vivo PK performance, a surrogate for clinical outcomes. Alternatively, with the intention of improving the efficiency of the drug product development process by limiting the burden of conducting in vivo studies, this understanding can be either built, or at least enhanced, through in silico efforts, such as IVIVC and physiologically based pharmacokinetic (PBPK) absorption modeling and simulation (M&S). These approaches enable dissolution testing to establish safe boundaries and reject drug product batches falling outside of the established safe range (e.g., due to inadequate in vivo performance) enabling the method to become clinically relevant. Ultimately, these efforts contribute towards patient-centric drug product development and allow regulatory flexibility throughout the lifecycle of the drug product.

On May 15th–17th, 2017, the US FDA and the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) held a workshop at the University of Maryland’s Center of Excellence in Regulatory Science and Innovation (M-CERSI), to discuss the role of dissolution testing and translational modeling and simulation in enabling patient-centric solid oral drug product development. This 3-day event was attended by scientists from regulatory agencies, pharmaceutical companies, and academia. The workshop included podium presentations followed by breakout session discussions. The first day of the meeting focused on the challenges in dissolution method development and the role of dissolution testing throughout drug product development. On the second day, approaches to establish a link between in vitro testing and in vivo drug product performance (e.g., systemic exposure) were presented. Overall success rates and challenges in establishing IVIVCs via traditional and modern physiologically based pharmacokinetic (PBPK) modeling and simulation approaches were discussed. Day 3 provided an opportunity to discuss the expectations for establishing clinically relevant drug product specifications (CRDPS). It was recognized that understanding the impact of formulation and process variations on dissolution and in vivo performance is critical for most drug products formulated with poorly soluble drugs to ensure consistent product performance. The breakout sessions served as platforms for discussing controversial topics such as the clarification of dissolution terminology, PBPK model development and validation expectations, and approaches to set CRDPS. The meeting concluded with a commitment to continue the dialog between regulators, industry, and academia to advance overall product quality understanding.

This article intends to summarize the current views of the IQ Consortium Dissolution Working Group, which comprises various industry companies, on the roles of dissolution testing throughout pharmaceutical product development, registration, commercialization, and beyond. Over the past 3 decades, dissolution testing has evolved from a routine and straightforward test as a component of end-product release into a comprehensive set of tools that the developer can deploy at various stages of the product life cycle. The definitions of commonly used dissolution approaches, how they relate to one another and how they may be applied in modern drug development, and life cycle management is described in this article. Specifically, this article discusses the purpose, advantages, and limitations of quality control, biorelevant, and clinically relevant dissolution methods.

This manuscript represents the perspective of the Dissolution Analytical Working Group of the IQ Consortium. The intent of this manuscript is to highlight the challenges of, and to provide a recommendation on, the development of clinically relevant dissolution specifications (CRS) for immediate release (IR) solid oral dosage forms. A roadmap toward the development of CRS for IR products containing active ingredients with a non-narrow therapeutic window is discussed, within the context of mechanistic dissolution understanding, supported by in-human pharmacokinetic (PK) data. Two case studies present potential outcomes of following the CRS roadmap and setting dissolution specifications. These cases reveal some benefits and challenges of pursuing CRS with additional PK data, in light of current regulatory positions, including that of the US Food and Drug Administration (FDA), who generally favor this approach, but with the understanding that both industry and regulatory agency perspectives are still evolving in this relatively new field. The CRS roadmap discussed in this manuscript also describes a way to develop clinically relevant dissolution specifications based primarily on dissolution data for batches used in pivotal clinical studies, acknowledging that not all IR product development efforts need to be supported by additional PK studies, albeit with the associated risk of potentially unnecessarily tight manufacturing controls. Recommendations are provided on what stages during the life cycle investment into in vivo studies may be valuable. Finally, the opportunities for CRS within the context of post-approval changes, Modeling and Simulation (M&S), and the application of biowaivers, are briefly discussed.

This report analyses trends in agriculture for the US Southwest region, one of the most water stressed and productive agricultural regions in the world expected to face further water shortages in the future due to climate change and continued growth. It examines projected water risks by mid-century without additional policy action, and discusses the expected implications for the agriculture sector, based on a review of existing data and available publications. The region will likely continue to be a major agricultural producer by mid-century but will be affected by more variable and uncertain water supplies and increased water demand. Irrigated area is likely to decline, with lower value, water-intensive field and forage crops experiencing the greatest losses. Livestock and dairy are also especially vulnerable to water shortages and climate change. Trade and employment may be affected, although projections remain uncertain. Policy options can help mitigate these projected water risks, such as agricultural and urban water efficiency improvements, refined groundwater management, investment in water banks and recycled wastewater systems, and well-defined water transfers.

Britain honored its international commitment under the Balfour Declaration for the duration of the 1920s in order to retain control of Palestine – a strategic buffer to the Suez Canal. The import of Jewish capital and revenues from Zionist enterprise and commerce in Palestine enabled it to do so. Not only was Britain able to administer Palestine at a minimal cost to the British taxpayer, but it also used Zionist-generated capital to finance its own imperial projects in the region: the construction of Haifa harbor, and an oil pipeline and road from Baghdad to Haifa.

Carotid angioplasty and stenting (CAS) has been touted as a reasonable alternative to carotid endarterectomy (CEA) for high-risk surgical candidates. Several published CAS series, primarily from academic centers, show immediate results approaching those of CEA. However, very little is known about long-term results with CAS, particularly in the community hospital setting. Therefore, we retrospectively reviewed our CAS experience. From February 1999 to July 2003, 44 consecutive patients underwent placement of 46 stents. The mean patient age was 73 years, and 57 per cent were men. Most patients were asymptomatic (74%). High-risk categories included prior CEA (71%), other anatomic risks (13%), and/or significant medical comorbidities (16%). Technical success was achieved in all 46 cases. At 30 days, there were no deaths and one stroke, giving a combined stroke/mortality of 2 per cent. Clinical follow-up was obtained on all 44 patients at a mean follow-up of 42 months. Duplex scans performed on 44 stents (96%), at a mean follow-up of 40 months, demonstrated four 60 per cent to 79 per cent recurrent stenoses. CAS in a community hospital can have a 30-day stroke/mortality equivalent to CEA. The procedure is durable, with no critical (80%–99%) carotid restenoses and no stroke or transient ischemic attacks referable to a stented carotid artery in long-term follow-up.

TOPIC A majority of people with serious mental illnesses want to return to work as part of their recovery, but access to effective employment services is limited. This report highlights the role that families can take to advocate for access to high-quality services for their relatives with mental illnesses. PURPOSE This report summarizes major accomplishments of the family advocacy for the Individual Placement and Support (IPS) supported employment project, which is part of the Johnson & Johnson-Dartmouth Community Mental Health Program. SOURCES USED This description draws on published literature related to the role of families on behalf of individuals living with serious mental health conditions and supported employment services. The experiences of family members as advocates for change are also included. CONCLUSIONS AND IMPLICATIONS FOR PRACTICE Family teams can play a key role in changing public policy to increase access to evidence-based employment services and in promoting high-quality services at the local level in partnership with state mental health and vocational rehabilitation agency leaders responsible for employment services. In addition, family teams can educate their peers to better understand the role of work in recovery.

This study evaluated the effectiveness of a guided assessment and service planning intervention in improving the clinical practices of non-physician community mental health providers caring for older persons. Thirteen agencies, 44 clinicians, and 100 consumers (age 60 and older) were assigned to the intervention or a comparison group receiving usual care. Baseline interviews of clinicians and chart reviews found that clinicians' routine evaluation and service planning practices showed inattention to key domains such as substance abuse (over 33% of clinicians), suicide risk and dangerous behaviors (over 40%), and caregiver burden and risk of neglect or abuse (over 75%). At 1-year follow-up, the intervention was associated with increased rates of routine assessments of major symptom, functioning, and support domains. There was also significant improvement in the specificity of treatment planning within the intervention condition. Implications for quality improvement are discussed.

The first, long-awaited deliveries of Colorado River water to Tucson, Arizona, in the early 1990s resulted in millions of dollars worth of damage to homes and generated thousands of claims and complaints. In 1995, voters decisively rejected decades of planning by local and state water agencies and approved a citizen-sponsored initiative that prohibited the city from delivering Colorado River water for 5 years. A challenge was defeated in 1997, but voters reversed themselves in 1999. Support for the prohibition of Central Arizona Project (CAP) water in 1995 was strongly correlated with those areas that received initial delivery of Colorado River water, which is particularly notable since close to 40 percent of those affected were ineligible to vote. The response of voters near a groundwater Superfund site, however, showed support for CAP.

A cadaveric and radiographic study was undertaken to demonstrate the change in intersesamoidal crista architecture after an osteotomy that corrects the proximal articular set angle (PASA). Three cadaveric first metatarsals with hallux valgus deformity were utilized. Separate Kirschner wires representing the longitudinal axis bisection, PASA, and the long axis of the crista were placed into each specimen. After osteotomy, the metatarsal heads were translated laterally, rotated parallel to the transverse plane to correct PASA, and impacted. The relationship between the crista and the long axis of the metatarsal was determined. A deviation in the alignment between the intersesamoidal crista and the long axis of the metatarsal following the osteotomy was observed. The radiographic portion of this study correlated intermetatarsal angle, PASA, and tibial sesamoid position with intersesamoidal crista appearance on sesamoidal axial radiographs. Radiographic parameters in 19 patients (34 feet) were compared and two distinct patterns were evident: 1) A proximal articular set angle greater than 15 degrees was associated with complete crista erosion in 10 feet (91% of this subgroup); 2) a tibial sesamoid position greater than three was associated with partial or complete erosion in 17 feet (100% of this subgroup). A higher deviation of PASA and increased displacement of the sesamoidal apparatus correlated with crista erosion. These findings suggest that the crista fails to adapt with PASA as hallux valgus progresses and undergoes erosion instead. This study suggests that when correcting the PASA, misalignment of the sesamoid apparatus may lead to sub-first metatarsal arthrosis.

Carotid angioplasty and stenting (CAS) is being promoted for patients with carotid artery stenosis who have received neck irradiation. We reviewed our experience with carotid endarterectomy (CEA) following neck irradiation to determine if indeed postoperative and long-term problems were an issue in these patients. Over the past 13 years, 10 patients with a history of neck irradiation underwent 11 procedures. The average time interval between radiation treatment and surgery was 14 years (range 1-44). All carotid arteries were repaired with a standard endarterectomy, eight of which were patched. Three patients had undergone a radical neck dissection on the side ipsilateral to the carotid lesion. They received a pectoral myocutaneous flap (PMF) to protect the carotid artery and optimize wound healing. The lack of perioperative complications and of morbidity indicate that carotid reconstruction for patients with previous neck irradiation is safe and durable. Until long-term favorable results with CAS are available for these patients, operative intervention should remain the standard treatment.

As a result of advances in microcomputer technology over the past several decades, a number of new and improved intraoperative and ICU monitors have emerged for safer anesthetic, surgical, and postoperative management of patients. In particular, those developed for neuromonitoring are some of the most recent and potentially most important. One of the most common applications of intraoperative neuromonitoring is for the detection of cerebral ischemia and embolism during carotid endarterectomy surgery. By examining the period following crossclamping of the carotid arteries for plaque removal, thresholds for cerebral ischemia have been determined for a host of neuromonitoring techniques: electrical brainwaves, cerebral perfusion, and cerebral oxygenation. Information provided by these various techniques can be used to influence the surgeon's decision for selective shunting. With the introduction of continuous transcranial Doppler, the detection of emboli is now possible, also providing the surgeon w...

Literature is sparse concerning the topic of Charcot foot reconstruction incorporating various types of bone grafts and internal fixation. No concrete, methodical approach has yet been established to dictate under what conditions bone grafting would be applicable in Charcot joints. It is the intent of the authors to convey, through limited experience, an approach to the surgical reconstruction of the diabetic Charcot foot using bone grafting and internal fixation as it applies to the Sanders and Mrdjenovich patterns 2 and 3. Three case studies are presented, with emphasis on the biomechanical examination, computerized tomography, radiographic appearance, patterns of bone and joint destruction, and types of bone grafts using internal fixation.

Previous studies have demonstrated that significant changes in action or behaviour (function) and morphology occur in the deafferentated and the adjacent somatosensory cortex after amputation or experimental spinal cord injury. These studies have shown changes in somatotopic mappings and somatosensory perception as well as altered evoked responses. The purpose of the present study was to examine the potential effect of these changes on cognitive processes using the tactile P300 event-related potential (ERP) in a spinal cord injured (SCI) population. The P300 ERP has been associated with more complex cognitive functioning such as selective attention, memory, and stimulus evaluation rather than earlier sensory processing of stimuli. Three groups consisting of healthy control, paraplegic, and tetraplegic subjects participated in a transcutaneous electrical stimulation 'oddball' task. Results indicate that all groups were successful in maintaining target counts and produced significantly larger P300 amplitudes with longer latencies to target trials compared to non-target trials. The SCI groups, however, produced P300 ERPs for both targets and non-targets that were significantly reduced in amplitude compared to the control group. In the case of the tetraplegia patients, the P300 was almost abolished. No differences in latency of the P300 was observed between any of the groups.

Recovery from spinal cord injury (SCI) requires substantial coping by the patient. The coping process reflects both physical adjustment to permanent biological changes and psychological acceptance of these changes and their limitations to function. A history of family alcoholism appears as one prominent factor in persons with SCI. This factor is associated with several personality characteristics that could directly influence adjustment to the injury. As an initial exploration of this premise, the present study examined the relationship between family history of alcoholism and coping processes in SCI patients. Ninety volunteer subjects were selected from inpatient and outpatient populations of a Veterans Affairs spinal cord injury service. Based on structured interviews and responses to a standardized questionnaire, one group of 45 subjects, designated Family History Positive (FHP), were from families in which the father and at least one other second generation relative were alcoholics. The 45 Family History Negative (FHN) subjects were from families with no alcoholism subjects were from families with no alcoholism history. Once assigned to a group, subjects completed the Ways of Coping Questionnaire. Compared to subjects with no family alcoholism history, FHP subjects reported significantly more use of constructive coping strategies as measured by the Ways of Coping Questionnaire, but their alcohol use and anti-social behaviors indicated that they were less effective in actual coping behaviors. Persons with SCI and a family history of alcoholism reported utilization of coping methods that differ from those used by patients with SCI and no family alcoholism history. From the perspective of treatment and rehabilitation, this finding suggests the need to consider different therapeutic approaches for these groups.

Of the many factors that affect the occurrence of and rehabilitation from spinal cord injury, alcohol use and abuse are particularly prominent. Persons with a family history of alcoholism are at greater risk for alcohol abuse and alcoholism. Preliminary data show a much higher than normal proportion of these persons in the spinal cord injured population. If these data are reliable, they may show that family history of alcoholism is a premorbid or comorbid factor to the occurrence of accidents that results in catastrophic injuries. Our investigation represented an evaluation of this premise.Male volunteer subjects (N = 100) were selected from inpatient and outpatient populations of a Veterans Affairs spinal cord injury service. Subjects received a comprehensive interview and completed two standardized questionnaires and a general information form designed to evaluate their past and present use of alcohol and the use of alcohol by their parents and relatives.The incidence (45%) of spinal cord injured patients with a family history of alcoholism was over four times that found in the general population. Spinal cord injured subjects with a family history of alcoholism reported significantly more problems with alcohol before, at the time of, and after their injury.The data suggest a relationship between the predisposition to alcoholism and accidents that result in catastrophic injury.

Freshwater is a fundamental resource, integral to all ecological and societal activities, including food and energy production, transportation, waste disposal, industrial development, habitat for fish species, and human health. Yet freshwater resources are unevenly and irregularly distributed, with some regions of the world extremely short of water. Political borders and boundaries rarely coincide with borders of watersheds, ensuring that politics inevitably intrude on water policy. Indeed, over 260 river basins are shared by two or more nations. Just as oil creates disputes between states, water also plays a role in international conflicts. Inequities in the distribution, use, and consequences of water management have been a source of tension and dispute. In addition, as previous volumes of The World’s Water have explored (see, for example, Gleick 1998), water resources have been used to achieve military and political goals, and water systems and infrastructure, such as dams and supply canals, have long been military targets.

Fossil fuels are essential to the global economy—for electricity production, transportation, plastics and chemicals manufacturing, heating, and many other purposes. However, the extraction and processing of fossil fuels, in addition to their use, have profound impacts on the environment and natural resources, including water. Large oil spills— such as the recent Deepwater Horizon drilling rig spill, which leaked over 4.9 million barrels (780,000 cubic meters) of crude oil into the Gulf of Mexico—have focused attention on the potential for disasters associated with oil drilling to cause contamination of the natural environment (Lubchenco et al. 2010). The growing recognition of the serious risks to surface-water and groundwater quality from natural gas fracking operations also raises new questions. And even normal fossil-fuel extraction and refining processes pollute the environment.

Over the last decade, there have been competing explanations for the contextual interference effect in motor learning. One notion (Lee and Magill 1983) describes the effect in terms of the movement-plan reconstruction processes acquired with practice, while an alternative (Shea and Zimny 1983, 1988) emphasizes that the types of multiple processing strategies developed with practice are responsible for the effect. In this project, we examined how the various processes, as proposed by both of these explanations, influence the acquisition and retention of a simple aiming task. The methodology employed to address this problem supplemented practice schedules with various interpolated activities in the post-KR delay interval. In experiment 1, exemplar modals about the same-trial, next, or other (randomly determined) movement goal were provided to random practice conditions. Results indicated that there were detrimental and slight beneficial effects for retention when these types of models were provided, relative to a control condition. Experiment 2 further examined the post-KR delay activities that could enhance the cognitive processing associated with effective retention in both blocked and random practice. Findings from this experiment indicate that different types of interpolated activities presented in the post-KR delay interval facilitate retention for blocked practice conditions. Together, results from both experiments suggest that both elaboration and reconstruction processes can be beneficial for long-term retention.

We questioned whether deafferentation following SCI would result in an increase in somatic sensitivity possibly due to cortical reorganization. Dysesthetic pain syndrome (DPS) below the level of a spinal cord injury (SCI) is a common complication. We hypothesized that DPS patients would show increased cortical reorganization because of high levels of sensory stimulation following injury. Sixteen dysesthetic pain SCI patients, 15 SCI patients without pain, and 16 control subjects were examined for two-point discrimination thresholds (2PDT) of the forearm, neck, and spine. The SCI pain group had significantly smaller 2PDTs than either SCI no pain or control groups, particularly over the neck and spine. The SCI pain group had a significant inverse correlation between perceived degree of pain (visual analogue scale) and 2PDT in the spinal skin area. The findings indicate that SCI patients with severe DPS have a higher sensitivity to somatosensory stimuli, particularly in skin areas with projections to primary somatosensory cortex areas adjacent to the deafferentated region. The increase in 2PDT may be due to an increase in the size of the somatosensory cortical areas allotted to the corresponding skin areas.

In intact humans, deprivation of somatosensory and kinesthetic sensations result in significant alterations in perception and information processing. There have been very few studies to discover if the loss of sensation with spinal cord injury (SCI) in humans affects perceptual operations. We hypothesized that the SCI participant would either exhibit arousal, perceptual, and information processing alterations similar to experimentally sensory deprived subjects (who provide the closest human analogue), or that the somatosensory cortex would show reorganization for the processing of other modalities of stimulation. The subjects consisted of 16 paraplegic, 13 quadriplegic, and 22 non SCI controls. Subjects received an auditory orienting task consisting of a 500 Hz tone presented 20 times each at 66, 75, 88, and 101 db and a visual orienting task incorporating light flashes of 115, 123, 131, and 140 lux presented 20 times each. EEG information processing data were recorded from C3 and C4 for 100 msec prior to and 500 msec post stimulation. Information processing variables, analyzed as event-related potentials, indicated that the somatosensory cortex of SCI groups had a flattened response to auditory stimulation. The control group had a significantly larger P2 component. We concluded that these data signified that the somatosensory cortex did not reorganize function in response to chronic deafferentation nor was the SCI subject hyperresponsive to stimulation.

Cerebral control of foot movements has received limited study. Functional MRI compared slow with rapid foot movement, and right (dominant) with left foot movement. Brain activation during right, as compared with left, foot movement was larger, with higher amplitude task-related motor cortex signal change, and higher laterality index. Brain activation during fast, as compared with slow, foot movement was larger in cortical and cerebellar areas but smaller in deep gray areas. Some principles of cerebral control of hand movement extend to foot, but exceptions found include that dominant foot movement showed greater activation than did nondominant, and faster foot movements activated bilateral deep gray matter structures less than did slower. Results might have utility in trials of restorative therapies.

Background: This study compares central venous catheters (CVC) and peripherally inserted central catheters (PICC) for indications for insertion, complications, and economic impact. Methods: A retrospective review of 838 (283 CVC, 555 PICC) consecutively placed venous catheters reflected 49,365 CVC and 11,814 PICC days. Results: There were 57 (20%) complications in the CVC group, 197 (35%) complications in the PICC group. PICC were associated with a statistically significant increase in the incidence of catheter malfunction (P = 0.0005), arm vein phlebitis (P = 0.0004), and overall complications (P = 0.00001). A higher complication rate was noted in PICC inserted for chemotherapy (P = 0.00001) and parenteral hyperalimentation administration (P = 0.04). Charges for inpatient insertion of PICC and CVC were $500 and $2,500, respectively. Conclusions: PICC have a significantly higher complication rate than CVC. PICC provide cost-effective central access of 2 to 3 weeks’ duration, reserving operatively placed CVC for longer access requirements.

During the period of October 1985 through March 1995, 25 patients presented to the Veterans Affairs Medical Center, Miami with a chief complaint of chronic pain status post calcaneal joint depression fracture. Their acute injury was treated conservatively at this and various other institutions. Nine patients were managed conservatively with orthotics, University of California Biomechanics Laboratory braces (UCBLs), shoe modification, or prosthetics. Sixteen patients underwent hindfoot fusions. Good to excellent results were obtained in 15 of the 16 fusions. The remaining patient, having an isolated subtalar fusion, was later diagnosed with multiple sclerosis. Proper evaluation of the chronic pain patient is critical when mapping out an appropriate treatment plan. Hindfoot arthrodesis with soft tissue decompression is a successful tool in eliminating chronic pain due to malunited depression fractures.

In an effort to understand the mechanisms involved in dysesthetic pain syndrome (DPS) in spinal cord injury (SCI) patients, four groups of 13 subjects each--SCI subjects with DPS, SCI subjects without pain, chronic low back pain subjects, and control subjects--were examined for sensory detection and pain thresholds at forearm, neck, and rostral trunk areas. Results indicated that the SCI pain group had significantly lower pain thresholds at all skin sites, compared to the SCI no-pain and chronic low back pain groups, and at the rostral trunk skin site, compared to the control group. The SCI pain group also showed a lower sensory detection threshold at the rostral trunk skin site than did the SCI no-pain group. Equally important, the SCI no-pain group had detection and pain thresholds significantly higher than those of the control group. The results suggest fundamental differences in somatosensory processing when DPS is or is not a consequence of SCI.

Previous studies have observed altered somatotopic sensory fields after experimental deafferentation in animals as well as enhanced somatosensory evoked potentials and altered cortical motor pathways following spinal cord injury (SCI) in humans. These observations indicate that cortical reorganization may occur subsequent to SCI. In earlier work, we have observed attenuated amplitudes for both tactile P3 and auditory N1/P2 orienting event-related potentials (ERP) in spinal cord injured groups. These results suggest that the reorganization process may have functional perceptual and cognitive consequences. In an effort to determine if deafferentation affects the P3 ERP using stimuli other than somatosensory, we measured brain activity from central recording sites during an auditory "oddball" task. Additionally, we obtained brainstem auditory evoked responses (BAER) in order to assess subcortical primary auditory pathways as well. Results show that the SCI groups produced significantly attenuated N1/P2 complexes and P3 when compared to controls. Also, the quadriplegic group exhibited increased latencies of the P3 at frontal and central sites. There were no differences between groups in BAER results. These findings suggest that primary subcortical auditory information processing stages remain intact after SCI although later stages may be significantly altered.

This study was carried out to determine the subsequent fate of the greater saphenous vein and the efficacy of its high ligation along with surgical excision or sclerotherapy of varicosities. From 1988 to 1990, 22 patients underwent high ligation and sclerotherapy, 22 underwent high ligation and varicose vein excision, and four underwent high ligation alone. There were 36 women and 12 men patients. The average patient age was 48. Sixty limbs were scanned by duplex ultrasound pre- and postoperatively to determine the status of the greater saphenous vein. Average follow-up time was 10 months. Patients and surgeons rated the results of therapy for ablation of varicosities and alleviation of symptoms. Surgical complications were evaluated. At postoperative scan, 47 greater saphenous veins (78%) were found to be completely patent, nine (15%) were thrombosed for a short segment (less than 10 cm) and four (7%) were more significantly thrombosed. Those limbs in which high ligation and sclerotherapy were performed had the highest complete patency rate (96%). Patient and surgeon satisfaction was good to excellent in every case. The only complications were three symptomatic greater saphenous vein thromboses. Although follow-up is relatively brief, complete patency of the ligated greater saphenous vein was found in most cases. High ligation allows preservation of a patent greater saphenous vein, which can be used as an arterial conduit at a later date and gives therapeutic results comparable to stripping without the additional morbidity.

Acknowledged as a serious complaint of spinal cord injured (SCI) patients, chronic pain in this population is neither well studied nor well understood. To assess the quality and intensity of pain, a group of 49 SCI patients seeking treatment for chronic pain was compared to a general group of 95 patients from the Comprehensive Pain Clinic (CPC) on selected demographic variables, the McGill Pain Questionnaire (MPQ) and the Minnesota Multiphasic Personality Inventory (MMPI). The SCI patients were categorized as functionally incomplete SCI (SCI-I) or complete SCI (SCI-C). Multivariate analyses revealed differences among groups on the MPQ for Number of Words Checked, Rank Sum and the Affective dimension. In all cases the CPC group scored higher than the SCI-C group. The MMPI profiles were elevated and typical for the CPC and SCI-C groups and substantially less elevated for the SCI-I group. We suggest in cases where chronic pain is secondary to a chronic medical catastrophe, aspects of the MPQ and the MMPI assess the person's total medical disability and not just the meaning and impact of pain.

A treatment-outcome study was conducted to study the impact of behavior and physical therapy on components of the chronic low back pain syndrome. Eighteen patients received behavior therapy and 15 patients received physical therapy. All patients had at least a 6-month history of seeking treatment for chronic low back pain. Prior to treatment patients were assessed in four principal areas of functioning: (1) physical abilities; (2) current physical functioning; (3) psychological and psychosocial functioning; and (4) pain intensity and pain perception. Treatments were conducted in a group (five to eight patients) outpatient setting. Both behavior therapy and physical therapy groups met for 10-weekly sessions, each lasting 2 hr. Behavior therapy was designed to address the environmental, social, and emotional components of the low back pain syndrome as well as the depression and decreased activity that result from chronic low back pain. Physical therapy was based upon traditional rehabilitation theory and was designed to improve low back function. Patients were reevaluated at posttreatment, 6 months, and 1 year. The results showed a general improvement for patients in both groups and a few treatment-specific differences in outcome measures.

SYNOPSIS Descriptions of migraine and muscle tension headaches have been based primarily on retrospective medical histories. To obtain a more accurate picture of symptoms patients use to classify these headaches, a sample of 10,000 headaches was gathered from daily diaries. Patients experiencing both migraine and tension headaches are able to differentiate these disorders consistently, using moderate ratings of intensity, low ratings of disability, and short length for tension headaches, and ratings of relatively high intensity and disability, moderately long duration, and occasional gastrointestinal upset for migraine headaches. These configurations confirm the general view obtained from medical histories.

Conducted a treatment-outcome study to investigate the effectiveness of behavioral (BT) or physical therapy (PT) for treating chronic low back pain (CLBP). Thirteen patients received BT; 12 patients received PT. All patients had at least a 6-month history of seeking treatment of CLBP. Prior to treatment patients were assessed in four principal areas of functioning: (1) physical abilities; (2) current physical functioning; (3) psychological and psychosocial functioning; and (4) pain intensity and pain perception. Treatments were conducted in a group (5-8 patients) outpatient setting. Both BT and PT met for 10 weekly 2-hour sessions. BT was designed to address the environmental, social, and emotional influences of the pain experience, depression, and decreased activity from CLBP. PT was based upon traditional rehabilitation theory and was designed to improve low back function. The posttreatment results showed general improvement for patients in both groups, but few treatment-specific differences in outcome measures.

Forty-two migraine headache patients participated in an appraisal of biofeedback for differential finger warming--forehead cooling, frontalis EMG relaxation, alpha enhancement and vasoconstriction of the temporal scalp arteries. All patients provided 8 weeks of baseline charting of headache and then received 24 training sessions in one of the above conditions. Headache charting continued throughout training and for 8 months posttraining. During the training period measures were made of each biofeedback variable plus forehead temperature, heart rate, skin conductance, and finger pulse amplitude. Analyses revealed that all groups had a significant reduction in number of headaches per week with no change in intensity, disability or length of headache. Physiological changes were consistently small and unrelated to headache outcome. A nonspecific effect for biofeedback is suggested with the likely candidates being a relaxation phenomenon or a cognitive explanation based upon perceived control.

Several biological theories of psychosomatic disorders predict that susceptible individuals will have stereotypic physiological responses to stress. This hypothesis was tested in a sample of 13 migraine headache subjects by observing their head and hand temperature, frontal electromyography (EMG), heart rate, skin conductance level, and finger pulse amplitude under the conditions of rest, orienting to a tone, time estimation, reaction time, and mental arithmetic. Thirteen nonheadache cohorts served as a control group. For the migraine group, analyses of variance revealed significantly warmer head and hand temperatures and lower frontal EMG. Range-corrected data, which allow comparisons among the physiological measures, showed the migraine group to have a more stereotypic response pattern across tasks. Discriminant analyses, using both untransformed and range-corrected data made excellent post-dictions of group membership.

The classic skin and internal organ system manifestations of systemic sclerosis developed in 4 individuals, each with an erosive, destructive chronic polyarthritis characteristic of rheumatoid arthritis. All had serum rheumatoid factors, anti-nuclear antibodies, hypergammaglobulinemia and circulating immune complexes. Each of the 4 has been resistant to treatment. The features of these patients, together with an analysis of this unusual coexistence of two connective tissue disorders, are presented.

The influence of motor responding and typical psychophysiological tasks on heart rate was tested by manipulating motor requirements of reaction time (RT) and time estimation (TE) tasks. Thirty-four volunteers were assigned randomly to four groups. Two groups squeezed a hand dynamometer at the start of a trial and the other two groups squeezed at the finish of the trial. The force of the squeeze was also manipulated: either 3 kg (3) or 7 kg (7). The four groups were Start 3, Start 7, Finish 3, and Finish 7. All subjects participated in the TE and RT tasks. The dependent variables were measurements of forearm flexor muscle tension, heart rate and skin conductance. It was found that the manipulations of when and with what force a person squeezed the dynamometer resulted in reliable group differences in muscle tension. The magnitude of acceleratory components of the triphasic (acceleration-deceleration-acceleration) cardiac response was amplified by tension. The magnitude of the deceleratory component seemed to depend on both muscle tension and stimulus processing. Except for the magnitude of the response-bound deceleration, RT and TE produced very similar heart rate responses, and skin conductance did not differ among groups. The data were interpreted as providing evidence that motor response acts as an amplifier for the phasic HR produced by common psychological paradigms.

Appraisal of chronic low back pain (CLBP) treatment outcome is incomplete unless results can be shown to be stable over an extended follow-up period. This paper concentrates on methods by which the long-term trends of objective outcome assessments can be studied and predictions developed given incomplete data. Employment and litigation status, self-rating of pain, activities, medications, and hospitalizations related to pain were periodically assessed in up to 210 graduates of a CLBP treatment program, over a period of 6 months to 5 years following treatment. Favorable outcomes were achieved by many of the respondents, and a good degree of stability in outcomes was observed in several of the measures. Few indicators were found which adequately predict long-term outcomes, however. Attrition in the sample and other possible systematic sources of bias are discussed.

Eight non-insulin dependent diabetic subjects and eight controls were studied during physical and psychological stress. Physiological measures of heart rate, finger pulse amplitude and blood pressure, as well as metabolic measures of blood glucose, insulin, catecholamines and glucagon were sampled during the experiment. Results indicate substantial physiological arousal during the tasks for both groups, but no changes in blood glucose. Despite signs of mild autonomic neuropathy, the diabetic subjects showed responses similar to the controls on the stress tasks. Overall, this study suggests that diabetic instability does not necessarily follow from physiological activity and stress hormone elevations.

To examine the interaction of marijuana and an induced state of stress, on both subjective and physiological measures, two groups of 15 subjects each were given a mental arithmetic task to perform. The sequence of events was 10 min each of pre-stress, stress, post-stress, intoxication (about 20 min), pre-stress, stress, post-stress. In the intoxication phase, one group smoked marijuana containing 14 mg Δ9-THC while the other group smoked a placebo. The dependent variables were forearm blood flow (FBF), heart rate (HR). and skin conductance (SC), and a subjective measure of stress–the Multiple Affect Adjective Checklist (MAACL). The results revealed all physiological variables to be reactive to the stress task. In addition, marijuana intoxication produced reliable increases in both pre-stress HR and FBF, and yet the physiological response to the post-intoxication stress period showed no significant decrement when compared In the placebo group. Discussion of these results centered around marijuana's effects on tonic and phasic reactivity.