Optimal port placement and enhanced guidance in robotically assisted cardiac surgery.

BACKGROUND: Optimal port placement and enhanced guidance in robotically assisted cardiac surgery is required to improve preoperative planning and intraoperative navigation. METHODS: Offline optimal port placement is planned on a three-dimensional virtual reconstruction of the patient's computed tomography scan. Using this data, an accurate in vivo port placement can be performed, which is achieved by augmented reality techniques superimposing virtual models of the thorax and the teleoperator arms on top of the real worldview. RESULTS: A new system incorporating both port placement planning and intraoperative navigation in robotically assisted minimally invasive heart surgery was established to aid the operative workflow. A significant reduction of operation time by improved planning and intraoperative support is anticipated. CONCLUSIONS: The enhanced intraoperative orientation possibilities may lead to further decrease in operation time and have the continuing ability to improve quality.

The Cognitive Symptom Checklist-Work in cancer patients is related with work functioning, fatigue and depressive symptoms: a validation study.

PURPOSE: The study objectives are to translate the 21-item Cognitive Symptom Checklist-Work (CSC-W21) to Dutch (CSC-W DV) and to validate the CSC-W DV in working cancer patients. METHODS: The CSC-W21 was cross-culturally translated and adapted to a Dutch version. In this 19-item version, the dichotomous response option was changed to an ordinal five-point scale. A validation study of the CSC-W DV was conducted among cancer patients who had returned to work during or following cancer treatment. Internal consistency (Cronbach's α), structural validity (exploratory factor analysis) and construct validity (hypothesis testing) were evaluated. RESULTS: In a cohort of 364 cancer patients, 341 (94 %) completed the CSC-W DV (aged 50.6 ± 8.6 years, 60 % women). Exploratory factor analysis revealed two subscales 'working memory' and 'executive function'. The internal consistency of the total scale and subscales was high (Cronbach's α = 0.93-0.95). Hypothesis testing showed that self-reported cognitive limitations at work were related to work functioning (P < 0.001), fatigue (P = 0.001) and depressive symptoms (P < 0.001), but not to self-rated health (P = 0.14). CONCLUSIONS: The CSC-W DV showed high internal consistency and reasonable construct validity for measuring work-specific cognitive symptoms in cancer patients. The CSC-W DV was associated in expected ways with work functioning, fatigue and depressive symptoms. IMPLICATIONS FOR CANCER SURVIVORS: It is important to enhance knowledge about cognitive symptoms at work in cancer patients, to guide and support cancer patients as good as possible when they are back at work and to improve their work functioning over time.

Fear, alexithymia and cancer pain.

The purpose of this study was to examine the differential role of fear, anxiety, alexithymia, family factors and coping in cancer pain. Twenty-seven patients with pain related to cancer, 26 patients with chronic non-cancer pain, 26 patients with chronic illness but no pain (hypertensives) and 24 healthy controls completed a set of questionnaires during an initial interview and recorded severity and duration of pain, pain interference with activities, thoughts, behaviors and physiological responses associated with fear of pain, and coping strategies using a diary once daily for 7 days. In general, cancer patients reported lower pain levels than patients with chronic non-cancer pain. Contrary to anecdotal reports, cancer pain patients did not report fear of pain. Cancer patients and patients with chronic non-cancer pain reported similar levels of trait anxiety which was higher than non-pain patients. Alexithymia, as a measure of emotional expression, was associated with increased duration of pain in the cancer pain patients. Cancer pain patients also reported less use of coping strategies than patients with chronic non-cancer pain. Cancer patients did not report higher levels of family modeling of pain complaints or family use of medication. The perceived family environment of the cancer pain patient did not differ significantly from the 3 other groups. These results do not support anecdotal impressions that the level of reported pain and fear of pain is significantly greater in cancer pain in contrast to non-cancer pain. The results do indicate the importance of emotional expressivity in the modulation of cancer pain where the ability to assess and express emotions was associated with reduced pain.

ICD therapy in survivors of sudden cardiac death awaiting heart transplantation.

The impact of implantable cardioverter defibrillator (ICD) therapy on survival of heart transplant candidates is of major socioeconomic and ethical interest. However, efficacy is even uncertain for patients at highest risk of tachyarrhythmic death on the waiting list. We studied 60 selected heart transplant candidates (mean age, 55.8 years; mean left ventricular ejection fraction, 0.15; functional class III and IV) with a history of successful resuscitation by external electric defibrillation for spontaneous, syncopal ventricular tachyarrhythmia during the study period from March 1992 through September 1994. At the time of registration for transplantation, 30 patients had ICD devices implanted, whereas 30 patients lacked ICD therapy for various nonmedical reasons. Both therapy groups were comparable in clinical and hemodynamic characteristics as well as in intention to transplant (median waiting time to transplantation, 5.7 and 6 months, respectively; not significant by log-rank method). Survival on the waiting list was significantly improved by ICD therapy; only 1 of the 30 ICD patients (19 transplanted) but 7 of the 30 non-ICD patients (14 transplanted) died on the waiting list (p < 0.05 by log-rank method). Implantable cardioverter defibrillator therapy did not affect survival after transplantation as compared with non-ICD patients (not significant by log-rank method). During the waiting time, 26 of the ICD patients (87%) experienced adequate ICD discharges, and 12 of the non-ICD patients were treated successfully by external electric defibrillation (40%).(ABSTRACT TRUNCATED AT 250 WORDS)

A controlled evaluation of paraspinal EMG biofeedback in the treatment of chronic low back pain.

Sixty-six chronic low back pain sufferers were randomly divided into three groups. Following individual assessments consisting of psychological questionnaires, pain monitoring, and measurement of paraspinal electromyogram (EMG), one group received paraspinal EMG biofeedback and another a placebo treatment. The third group received no intervention. Two further assessments were carried out on all groups immediately after treatment and at a 3-month follow-up. All groups showed significant reduction in pain, anxiety, depression, and paraspinal EMG following treatment and at follow-up, but there were no differences between groups. A regression analysis failed to identify subjects' characteristics that predicted positive outcome in the biofeedback group. However, high scores on the Evaluative scale of the McGill Pain Questionnaire and high hypnotizability were significant predictors of positive outcome for the placebo group. It is concluded that paraspinal EMG biofeedback is not a specific treatment for chronic low back pain in a nonhospitalized population.

Pain expectancies, pain, and functional self-efficacy expectancies as determinants of disability in patients with chronic low back disorders.

This study tested the relative predictive power of self-efficacy expectations of physical capabilities (functional self-efficacy [FSE]), expectations of pain, and expectations of reinjury on physical function in chronic back patients. Before behavioral assessment of function, 85 patients rated their abilities to perform essential job tasks (FSE) and the likelihood that their performances would be accompanied by pain and reinjury. Partial correlations revealed that FSE was significantly related to function when reinjury and pain were partialed out. Neither reinjury nor pain expectancies correlated significantly with function when FSE was partialed out. Further support for an FSE approach came from regression analyses that found pain intensity, gender, and FSE--not expected pain or reinjury--related consistently with physical performance. Thus, performance-specific cognitions may have greater explanatory power over disability than pain-specific ones.

Stress and chronic headache: a psychophysiological analysis of mechanisms.

This study investigated the effects of three types of laboratory stressors (stressful imagery, mental arithmetic, pain) on temporal artery, skeletal muscle, general autonomic [digital blood volume pulse (DBVP), spontaneous resistance responses (SRR's)] and self-report measures of distress in chronic migraine, mixed, muscle contraction and non-headache controls. All subjects were female, free of medication at time of testing and equated for age. Headache subjects reported a 19 year history of headache. Results revealed a pattern of digital BVP (constriction), SSR's (increase) and frontal EMG (increase) indicative of a general autonomic-skeletal muscle arousal response to all three stressors in all groups, while the temporal artery response to the pain stimulus was vasodilation. Distress ratings were elevated during the stress periods for all four group. Pain threshold and tolerance and the tendency to utilize cognitive coping strategies during exposure to pain did not differ across the four groups. The results do not support the general autonomic dysfunction theory of migraine or the specificity hypothesis implicating an overreactive temporal artery or skeletal muscle response to stress in migraine and muscle contraction headache, respectively. Despite epidemiological research supporting the stress-headache relationship, the present results indicate that the psychophysiological mechanism underlying this relationship does not appear to involve abnormal tonic levels or phasic response to stress. It is argued that the temporal artery dilation response to pain questions the role of stress in triggering the two stage vasoconstriction-dilation mechanism of migraine and suggests the need to evaluate a four stage model as a potential psychophysiological mechanism underlying the stress-headache relationship.

Self-control and chronic headache.

The relationship between self-control and headache pain was studied in a sample of 42 female subjects with migraine or mixed migraine-muscle contraction headaches. Subjects completed questionnaires evaluating self-control tendencies and social desirability. The McGill Pain Questionnaire was also completed during a single representative migraine headache and daily ratings of headache severity (duration, intensity, disability due to pain) and medication intake were collected over a seven-week period. A significant discriminant function which resulted in 71% correct classification of High and Low Self-Control subjects was obtained. The pattern of responses associated with the high self-control group was characterized by lower ratings of pain intensity, less focus on sensory dimensions of pain and more frequent use of certain medications. A correlation between self-control and social desirability was also observed. These findings suggest that the trait self-control may be associated with a particular pattern of pain, although the influence of social desirability cannot be ruled out as an alternative explanation.

Musculoskeletal-related disability in US Army personnel: prevalence, gender, and military occupational specialties.

Research on military populations indicates that musculoskeletal-related disorders represent a prevalent source of outpatient visits, lost work time, hospitalization, and disability. Despite the increasing role of women in the military, little is known regarding the association among military occupations, gender, and disability. The study presented here analyzed 41,750 disability cases to determine: (1) prevalence of work-related musculoskeletal disability, (2) specific jobs associated with greater risk of musculoskeletal disability, and (3) association among gender, job-type, and disability. Results indicate: (1) back-related disorders represent the most prevalent sources of disability, (2) certain occupations were associated with higher disability risk, (3) women experienced higher overall, and musculoskeletal, disability risk, and (4) specific jobs were identified in which women experienced higher rates of musculoskeletal disability. These findings highlight the need to consider the interaction between workplace factors and gender on disability in the military work force.

Computer keyboard force and upper extremity symptoms.

This case-control study assessed whether office workers who report more severe levels of musculoskeletal symptoms of the upper extremities demonstrate higher levels of keyforce in comparison to controls with less severe symptoms. Office workers reporting working on computer keyboards for four hours per day were classified as cases or controls based upon a median split on a Composite Symptom Severity score (cases = 23, controls = 25). Keyboard force and keying rate were measured during a 15-minute keyboarding task. Measures of task-related discomfort, muscular fatigue, pain, upper extremity symptoms, psychological distress and force were collected at baseline, post-keyboard task, and recovery. Ratings of perceived effort and task credibility were also obtained. Measures of work demands, perceived job stress, and upper extremity strength and flexibility were also collected. The results indicated group equivalence on reported work demands and upper extremity strength. Cases were more likely to receive a medical diagnosis of upper extremity cumulative trauma disorder, awaken from sleep due to symptoms, report higher levels of pain during work, experience greater impact of pain on function, and report higher workload pressure and lower support. Cases generated significantly higher keyboarding forces than controls, although both groups produced forces well above that required to operate the keyboard (4-5 times activation force). Cases reported higher levels of upper extremity symptoms and discomfort than controls, and these measures were highest after the keyboarding task for both groups. No significant correlation between keyforce and key rate was observed in either group. Results suggest that generation of excessive force while working on a computer keyboard may contribute to the severity of upper extremity symptoms. Clinically, the findings suggest that evaluating how an individual worker performs keyboarding tasks, or his or her workstyle, may be helpful in the management of these symptoms and disorders.

Predictors of occupational low back disability: implications for secondary prevention.

Over the past decade, studies have identified a combination of demographic, physical/medical, ergonomic, and psychosocial factors in the development of work disability related to occupational low back pain. Using such data on disability risk factors, investigators have begun to develop risk identification and disability prevention programs. As part of an ongoing effort to develop a secondary prevention program, the present case-control study identified the relative contribution of demographic, physical demand, physical fitness, as well as occupational and individual psychosocial variables to back-related work disability in the US Army. Soldiers (n = 174) diagnosed with a lumbosacral strain and medically discharged from the Army were compared with non-disabled controls (n = 173). Dependent measures were obtained from the US Army Health Risk Appraisal (HRA). For cases, these data pre-dated disability determination by 1 to 3 years. For controls, the HRA was completed during the same time period. Significant predictors of low back disability were: age (odds ratio [OR] = 1.13 per year), lower rank (E2/E3) (OR = 4.08/OR = 3.02), infrequent aerobic exercise (OR = 2.2), higher work stress (OR = 2.71), worries (OR = 2.17), and lower social support (OR = 5.07). The model correctly classified 73.13% of all subjects. These results highlight the importance of considering age, status level in the organization, frequency of aerobic exercise, occupational stress, general worries, and social support for the early detection of soldiers at increased risk for back-related disability. Additionally, the findings support past research indicating the multivariate nature of work disability and emphasize the importance of considering such factors in future secondary prevention efforts.

Occupational upper extremity disorders in the federal workforce. Prevalence, health care expenditures, and patterns of work disability.

Upper extremity disorders (UEDs) account for a significant number of work-related illnesses in the US workforce. Little information exists on the distribution of UEDs, their associated health care and indemnity costs, or patterns of work disability. The study presented is an analysis of upper extremity claims within the federal workforce. In this study, the universe consisted of all claims accepted by the US Department of Labor, Office of Workers' Compensation Programs (OWCP), from October 1, 1993, through September 30, 1994. A total of 185,927 claims of notices of injury were processed during the study period, and of these, 8,147 or 4.4% had an UED diagnosis coded according to the International Classification of Diseases, Clinical Modification (ICD-9-CM). 5,844 claims involved a single UED diagnosis and were the only claims field by these employees between October 1, 1990, and September 30, 1994. These single claims with single diagnoses comprised the sample for further analysis. Mononeuritis and enthesopathies of the upper limb were the most common diagnoses, accounting for 43% and 31% of the claims, respectively. Women had a higher proportion of carpal tunnel syndrome, "unspecified" mononeuritis, and "unspecified" enthesopathies. The majority of claimants for both the mononeuritis- and enthesopathy-related diagnoses were between 31 and 50 years of age, received only health care benefits, and did not incur wage loss. Health care costs for mononeuritis and enthesopathy claims were $12,228,755 (M = $2,849). Carpal tunnel syndrome (CTS) and enthesopathy of the elbow were the most costly diagnoses, accounting for 57% and 16% of the total, respectively. Surgical services represented the highest expenditures in CTS claims. Physical therapy accounted for the majority of health care costs for enthesopathy cases. The mean number of workdays lost for CTS and enthesopathy claims were 84 and 79, and the average indemnity costs were $4,941 and $4,477, respectively. These findings indicate that while UEDs represent a relatively small percentage of all workers' compensation cases, the health care and indemnity costs are considerable. Also mean duration and pattern of work disability revealed that these disorders can result in chronic work disability similar to that observed in low back pain. The results highlight the need to determine whether interventions that account for the majority of costs significantly impact long-term outcomes. There is also a need to identify risk factors for prolonged disability in those who experience problems with delayed recovery.

Development of a screen for predicting clinical outcomes in patients with work-related upper extremity disorders.

This study prospectively examined the extent to which a set of medical, physical, ergonomic, occupational psychosocial, and individual psychosocial variables would predict clinical outcome associated with a diverse set of work-related upper extremity disorders in recently diagnosed individuals. This investigation was designed to develop a tool for use in a clinical setting to assist in identifying patients at risk for poorer outcome. Outcome was measured at 1, 3, and 12 months after completing a baseline questionnaire. Outcome status was based on a median split of a standardized composite index (symptoms, function, workdays lost, and mental health). Logistic regression indicated that predictors of poorer outcome at 1 month were: upper extremity comorbidity (risk ratio [RR], 1.58), pain severity (RR, 1.45), ergonomic risk exposure (RR, 1.07), low job support (RR, 1.03), and pain coping style (RR, 1.54). At 3 months, poorer outcome was predicted by: symptom severity (RR, 10.46), job stress (RR, 1.20), and pain coping style (RR, 1.98). The number of prior treatments/providers (RR, 1.77), past recommendation for surgery (RR, 6.43), and pain coping style were found to predict poorer outcome at 12 months. Sensitivity and specificity, respectively, for the models were 77.4% and 71.8% at 1 month, 80.6% and 82.4% at 3 months, and 80.6% and 83.3% at 12 months. The results indicate that baseline measures of ergonomic and psychosocial stress, pain severity, and pain coping style predict clinical outcome at shorter intervals, whereas number of past treatments/providers, recommendation for surgery and pain coping style predict longer-term outcome. The resulting prognostic screen provides a simple tool that assesses the multidimensional nature of work-related upper extremity disorders and predicts clinical outcome. Furthermore, the findings suggest the importance of early intervention that addresses both physical and psychosocial stressors at work. Specific recommendations to reduce the impact of observed risk factors are discussed.

Measuring functional outcomes in work-related upper extremity disorders. Development and validation of the Upper Extremity Function Scale.

Questionnaire-based measures of function have been validated extensively in studies of chronic illness and work-related low back pain. These measures have only recently been developed for upper extremity disorders (UEDs), and there is little information on their utility in evaluation of injured workers. We developed the Upper Extremity Function Scale (UEFS), an eight-item, self-administered questionnaire, to measure the impacts of UEDs on function. This instrument was tested in a cohort of 108 patients with work-related UEDs and 165 patients with the carpal tunnel syndrome (CTS); both groups were enrolled in prospective follow-up studies. The UEFS demonstrated excellent psychometric properties, including good internal consistency (Cronbach's alpha > 0.83), relative absence of floor effects, and excellent convergent and discriminant validity, compared with measures of symptom severity and clinical findings. In the CTS group, the UEFS was more responsive to significant improvements over time than clinical measures such as grip and pinch strength. These data support the use of a self-reported functional scale as a measure of outcome in studies of work-related UEDs. Further investigations in working populations are needed to substantiate its utility in workers with UEDs who have not yet sought medical care.

Work-related upper-extremity disorders and work disability: clinical and psychosocial presentation.

Work-related upper-extremity disorders (WRUEDs) are an increasingly common cause of work-related symptoms and disability. Although most upper-extremity disorders are acute and self-limited, a small percentage of workers with symptoms go on to permanent disability and account for the majority of costs associated with these conditions. Little is known, however, about this progression from symptoms to disability and how it might be prevented. In this study, we evaluate the demographic, vocational, medical, and psychosocial characteristics of patients with WRUEDs and examine several hypotheses regarding the differences between working and work-disabled patients. One hundred twenty-four consecutive patients were evaluated in a clinic specializing in occupational upper-extremity disorders. Patients currently working (n = 55) and work-disabled patients (n = 59) were similar with regard to age, gender, and reported job demands. The work-disabled group reported less time on the job, more surgeries, a higher frequency of acute antecedent trauma, and more commonly had "indeterminate" musculoskeletal diagnoses. They also reported higher pain levels, more anger with their employer, and a greater psychological response or reactivity to pain. These findings, though cross-sectional in nature, suggest that, in addition to medical management, more aggressive approaches to pain control, prevention of unnecessary surgery, directed efforts to improve patients' abilities to manage residual pain and distress, and attention to employer-employee conflicts may be important in preventing the development of prolonged work disability in this population.

Work-related upper-extremity disorders: prospective evaluation of clinical and functional outcomes.

The purpose of this study was to describe the demographic, vocational, medical, workplace, and psychosocial characteristics of patients treated for work-related upper-extremity disorders, to document treatment patterns in a community-practice setting, and to determine which of these factors predicts subsequent employment and functional status outcomes. A questionnaire was administered by mail or telephone to 112 patients seen at the University of Massachusetts Occupational Upper Extremities Disorders Clinic and included measures of disease-specific functional status, pain, reactions to pain, employer-employee relations, and number and type of interventions used to treat the disorder. Results were compared with baseline data obtained, on average, 16 months prior to follow-up. Of the original cohort (n = 124), 112 participated in the prospective study. Although most patients reported improvement in pain severity, fear of pain, life situation, and functional status, there was little change in employment status. Patients' self-reported intentions of return to work at baseline did not predict work status at follow-up. In general, those who were employed at baseline remained employed, had a greater reduction in symptom severity over time, and were significantly more likely to report improvement in their problem than those who were unemployed. The efficacy of various interventions was examined by type, mix, and intensity (number of different interventions undergone by the patient). No positive relationship was found between these measures and employment status, self-reported change in the problem, or self-reported improvement in functional status. Significant negative relationships were found between surgery, psychotherapeutic interventions, and outcomes. This was likely to have occurred because of a selection bias toward the more chronic and severely disabled patients for these treatments. However, the relative ineffectiveness of such intensive interventions as surgery in improving the work and health status of chronically symptomatic work-related upper-extremity patients cannot be overlooked. The findings suggest that more emphasis be placed on interventions aimed at resolving differences between employers and injured employees. More careful selection of patients for expensive and invasive procedures is recommended.

Health care and indemnity costs across the natural history of disability in occupational low back pain.

STUDY DESIGN: The administrative database maintained by the National Council on Compensation Insurance (United States) was used to compare health care use and indemnity costs within the natural history of work-related low back pain disability. OBJECTIVES: To determine the relative costs of health care services and indemnity at different phases of work disability. SUMMARY OF BACKGROUND DATA: Existing studies have compared total costs along the work disability continuum. This study replicates and extends these earlier studies by providing detailed evaluations of costs by service categories along this continuum. METHODS: Total health care and indemnity costs accrued along the disability curve were examined. Based on the number of days workers were absent from work and receiving indemnity payments (disability days), detailed mean health care costs by type of medial service were computed and compared across four time intervals for the sample. RESULTS: Health care costs were disproportionately distributed along the disability curve, with 20% of claimants disabled 4 months or more, accounting for 60% of health care costs. The most costly service category was diagnostic procedures (25% of total medical costs), with surgical costs (21%) and physical therapy (20%) representing the next two most costly categories. Mental health and chiropractic care represented a small percentage of overall costs (0.4% and 2.9%, respectively). CONCLUSIONS: These data provide policy-makers, program development, and health care industry groups with cost information from which to establish benchmarks for future decisions that facilitate the allocation of resources for more cost-effective management and prevention of work disability.

Reflex sympathetic imbalance. Response to epidural blockade.

Eleven patients (two male, nine female) were treated with epidural sympathetic blockade for reflex sympathetic imbalance, an incomplete manifestation of reflex sympathetic dystrophy. Each had developed severe pain, sensitivity, and disability disproportionate to associated trauma. One patient injured an ankle, and the remaining 10 patients one or both knees (12 knees). Seven patients had undergone previous surgery. All but one had a favorable response to initial blockade. This individual eventually failed treatment despite surgical sympathectomy. Seven have required readministration of a block for clinical relapse. Mean followup was 22 months (range, 10 to 41 months). Five underwent extensive psychological testing. All have required adjunctive forms of therapy including physical therapy, transcutaneous electrical nerve stimulation (TENS), antiinflammatory or other nonnarcotic agents. Recovery is typically prolonged, particularly if the diagnosis is delayed. Close attention to, and therefore prevention of, situations that trigger its recurrence is essential for successful rehabilitation.

Biobehavioral factors affecting pain and disability in low back pain: mechanisms and assessment.

Patients with recurrent or persistent low back pain (LBP) and disability represent a formidable challenge to physical therapists. Classic models of disease and pain mechanisms do not adequately explain the commonly observed discrepancies between the extent of pathology and reported pain, or the level of pain and disability. Research over the past decade that considers the interactive role of biological, environmental, and psychological processes in pain and disability has supported the involvement of a number of biobehavioral factors in these conditions. Physical therapists and other health care providers have become more aware of these factors and their impact on the evaluation, treatment, and management of LBP. Despite this recognition, little information is available that translates the implications of this research to direct care within physical therapy practice. The purposes of this article are (1) to provide an operational definition of biobehavioral factors; (2) to review the role of these factors in the clinical presentation of LBP, functional limitation, and disability; (3) to identify commonly used approaches for their recognition and quantification; (4) to illustrate how an understanding of biobehavioral factors can assist the physical therapist in evaluation and treatment of patients with LBP; and (5) to identify certain gaps in current knowledge of the role of biobehavioral factors and their application in physical therapy. Given the central role assumed by many physical therapists in the management of LBP, acknowledging and addressing these factors in clinical practice should assist in the prevention of chronic LBP and disability, as well as potentially improve physical therapy interventions and management.

Development of a multidisciplinary research clinic for patients with work-related upper extremity disorders.

The health care reform debate has focused attention on the need for outcomes research performed in ambulatory care settings. In this article, the authors describe the development of a research clinic focusing on symptomatic, functional, and vocational outcomes of patients with work-related upper extremity disorders. The authors describe the programmatic and research challenges associated with performing such research and emphasize the need for balancing the research and clinical agendas. Research efforts in this setting require careful consideration of the patient selection process and allocation of sufficient time for the clinical staff to collect and record essential research data.