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Biomedical subjects

Jennifer J Anderson

Publications and source records attributed to Jennifer J Anderson.

16 recordsLinked to original sources
PubMed2004

Improvement in quality of life of patients with AL amyloidosis treated with high-dose melphalan and autologous stem cell transplantation.

Treatment of AL amyloidosis patients with high-dose melphalan chemotherapy followed by autologous peripheral blood stem cell transplantation (HDM/SCT) can produce hematologic complete responses (CRs) and improvement in organ function. To determine whether these responses are accompanied by improvement in quality of life (QOL), we employed the Medical Outcomes Study (MOS) 36-item Short Form General Health Survey (SF-36) questionnaire for 544 patients evaluated between 1994 and 2002. At baseline, the scores were significantly lower on all 8 SF-36 scales compared with age-matched population norms: the composite physical component summary (PCS) for the AL patients was 34.5 versus the population norm of 46.8, and the mental component summary (MCS) was 45.0 versus the norm of 51.5. All SF-36 scores improved at 1 year, with the MCS reaching the population norm. The PCS, though improved, was still lower than normal but was greater in the subgroup of patients who achieved a hematologic CR; the PCS normalized at 2 years in these patients. Thus, treatment of AL amyloidosis patients with HDM/SCT produces measurable and sustained improvements in quality of life, particularly in those patients who achieve hematologic CR.

Amyloidosis↗
PubMed2004

High-dose melphalan and autologous stem-cell transplantation in patients with AL amyloidosis: an 8-year study.

BACKGROUND: AL amyloidosis is a fatal disease resulting from tissue deposition of amyloid fibrils derived from monoclonal immunoglobulin light chains. Treatment with oral chemotherapy is minimally effective. OBJECTIVE: To test survival and organ response in a large sample of patients treated with high-dose intravenous melphalan (100 to 200 mg/m2) and autologous blood stem-cell transplantation. DESIGN: 8-year longitudinal analysis of clinical effectiveness. SETTING: University-affiliated specialty referral clinic. PATIENTS: 701 consecutive new patients with AL amyloidosis. INTERVENTION: High-dose chemotherapy and autologous stem-cell transplantation for patients who met eligibility requirements based on organ involvement and clinical status. MEASUREMENTS: Survival analysis of all patients evaluated and a detailed analysis of treatment outcome in the subgroup that received high-dose melphalan and stem-cell transplantation. RESULTS: Among 701 patients with AL amyloidosis, 394 (56%) were eligible for high-dose melphalan and stem-cell transplantation; 82 did not proceed with treatment because of patient choice or disease progression. Median survival of the 312 patients who initiated treatment was 4.6 years. A complete hematologic response, defined as no evidence of an underlying plasma cell dyscrasia 1 year after treatment, was achieved in 40% of patients and was associated with prolonged survival. Statistically significant improvements occurred in end-organ disease and were greater in patients with a complete hematologic response. Mortality rate within 100 days of treatment with high-dose melphalan and stem-cell transplantation was 13%; patients with cardiomyopathy had the highest mortality rates. CONCLUSIONS: Treatment of selected patients with AL amyloidosis by using high-dose melphalan and stem-cell transplantation resulted in hematologic remission, improved 5-year survival, and reversal of amyloid-related disease in a substantial proportion.

Aged↗
PubMed2004

Proactive and reactive aggression in referred children and adolescents.

Investigating different types of aggression is important to facilitate a better understanding of excessive maladaptive aggression in referred youth. Using regression analysis, the authors investigated demographic, historical, diagnostic, and treatment correlates of proactive aggression and reactive aggression in a heterogeneous population (N = 323) of psychiatrically referred youths. Ratings of proactive and reactive aggression significantly correlated with more established measures of aggression. Results suggest the importance of hyperactive/impulsive behavior, disruptive behavior disorders, and self-reported hostility in youths with both reactive and proactive aggression. Substance use disorders, a family history of substance abuse, and family violence were specifically associated with proactive aggression. Younger age and a history of abuse were correlated with reactive aggression. Implications for clinical interventions and future research are discussed.

Adolescent↗
PubMed2003

Comparison of rheumatoid arthritis clinical trial outcome measures: a simulation study.

OBJECTIVE: Isolated studies have suggested that continuous measures of response may be better than predefined, dichotomous definitions (e.g., the American College of Rheumatology 20% improvement criteria [ACR20]) for discriminating between rheumatoid arthritis (RA) treatments. Our goal was to determine the statistical power of predefined dichotomous outcome measures (termed "a priori"), compared with that of continuous measures derived from trial data in which there was no predefined response threshold (termed "data driven"), and to evaluate the sensitivity to change of these measures in the context of different treatments and early versus later-stage disease. In order to generalize beyond results from a single trial, we performed simulation studies. METHODS: We obtained summary data from trials comparing disease-modifying antirheumatic drugs (DMARDs) and from comparative coxib-placebo trials to test the power of 2 a priori outcomes, the ACR20 and improvement of the Disease Activity Score (DDAS), as well as 2 data-driven outcomes. We studied patients with early RA and those with later-stage RA (duration of <4 years and 4-9 years, respectively). We performed simulation studies, using the interrelationship of ACR core set measures in the trials to generate multiple trial data sets consistent with the original data. RESULTS: The data-driven outcomes had greater power than did the a priori measures. The DMARD comparison was more powerful in early disease than in later-stage disease (the sample sizes needed to achieve 80% power for the most powerful test were 64 for early disease versus 100 for later disease), but the coxib-versus-placebo comparison was less powerful in early disease than in later disease (the sample sizes needed to achieve 80% power were 200 and 100, respectively). When the effects of treatment on core set items were small and/or inconsistent, power was reduced, particularly for a less broadly based outcome (e.g., DDAS) compared with the ACR20. CONCLUSION: The simulation studies demonstrate that data-driven outcome definitions can provide better sensitivity to change than does the ACR20 or DDAS. Using such methods would improve power, but at the expense of trial standardization. The studies also show how patient population and treatment characteristics affect the power of specific outcome measures in RA clinical trials, and provide quantification of those effects.

Antirheumatic Agents↗
PubMed2003

Gender differences in reactive and proactive aggression.

The purpose of our investigation was to study gender differences in proactive and reactive aggression in a sample of 323 clinically referred children and adolescents (68 females and 255 males). Proactive aggression and reactive aggression were assessed using the Proactive/Reactive Aggression Scale. Demographic, historical, family, diagnostic, and treatment variables were entered into stepwise regression analyses to determine correlates of proactive and reactive aggression in males and females. Results reveal high rates of aggression in both males and females in the sample. Self reported drug use, expressed hostility, and experiences of maladaptive parenting were correlated with proactive aggression for both genders. Hyperactive/impulsive behaviors were correlated with male reactive aggression. An early age of traumatic stress and a low verbal IQ were correlated with female proactive aggression. Gender differences in correlates of proactive and reactive aggression may provide possible targets for research, prevention, and treatment efforts focused on reducing maladaptive aggression in clinically referred youth.

Adolescent↗
PubMed2003

Applying diagnostic cost groups to examine the disease burden of VA facilities: comparing the six "Evaluating VA Costs" study sites with other VA sites and Medicare.

OBJECTIVES: To compare the disease burden of Veterans Health Administration (VA) patients at six study sites with all other VA patients and the Medicare population. DESIGN: A 60% random sample of all VA veteran patients during federal fiscal year 1997 was obtained from administrative databases. A split-sample technique provided a 40% sample (n = 1,046,803) for development and a 20% sample (n = 524,461) for validation. We selected the six study sites from the 40% sample, yielding a total of 50,080 patients in those sites. METHODS: We used Diagnostic Cost Groups to classify patients into clinical groupings based on age, gender, and International Classification of Diseases, Ninth Revision, Clinical Modification diagnoses. The Diagnostic Cost Group model produces relative risk scores that describe patients' expected resource use normalized to the Medicare population. We compared the severity of the six sites with each other and with all other VA facilities and the severity of VA patients with that of Medicare beneficiaries. RESULTS: There were minor statistically significant differences between the study sites and all other VA facilities. Compared with the Medicare population, VA's population was younger and had lower expected resource use (relative risk scores were 1.0 and 0.76, respectively). CONCLUSIONS: Disease burden of the six study sites is representative of all other VA facilities. Although lower relative risk scores suggest that VA patients are healthier than Medicare beneficiaries, when age is taken into account, scores are more comparable. Interpreting the expected resource utilization of the VA population against other benchmarks should be performed carefully.

Adolescent↗
PubMed2003

Quality improvement implementation in the nursing home.

OBJECTIVE: To examine quality improvement (QI) implementation in nursing homes, its association with organizational culture, and its effects on pressure ulcer care. DATA SOURCES/STUDY SETTING: Primary data were collected from staff at 35 nursing homes maintained by the Department of Veterans Affairs (VA) on measures related to QI implementation and organizational culture. These data were combined with information obtained from abstractions of medical records and analyses of an existing database. STUDY DESIGN: A cross-sectional analysis of the association among the different measures was performed. DATA COLLECTION/EXTRACTION METHODS: Completed surveys containing information on QI implementation, organizational culture, employee satisfaction, and perceived adoption of guidelines were obtained from 1,065 nursing home staff. Adherence to best practices related to pressure ulcer prevention was abstracted from medical records. Risk-adjusted rates of pressure ulcer development were calculated from an administrative database. PRINCIPAL FINDINGS: Nursing homes differed significantly (p<.001) in their extent of QI implementation with scores on this 1 to 5 scale ranging from 2.98 to 4.08. Quality improvement implementation was greater in those nursing homes with an organizational culture that emphasizes innovation and teamwork. Employees of nursing homes with a greater degree of QI implementation were more satisfied with their jobs (a 1-point increase in QI score was associated with a 0.83 increase on the 5-point satisfaction scale, p<.001) and were more likely to report adoption of pressure ulcer clinical guidelines (a 1-point increase in QI score was associated with a 28 percent increase in number of staff reporting adoption, p<.001). No significant association was found, though, between QI implementation and either adherence to guideline recommendations as abstracted from records or the rate of pressure ulcer development. CONCLUSIONS: Quality improvement implementation is most likely to be successful in those VA nursing homes with an underlying culture that promotes innovation. While QI implementation may result in staff who are more satisfied with their jobs and who believe they are providing better care, associations with improved care are uncertain.

Aged↗
PubMed2003

Deriving an operational definition of low disease activity state in rheumatoid arthritis.

This article summarizes the process proposed to come to a definition of low disease activity in rheumatoid arthritis (RA). The purpose of this definition is to aid the interpretation of trial and longitudinal study results. A conceptual proposal is "a disease activity state that is deemed a useful treatment target by both physicians and patients." An operant definition can be derived by judgmental (opinion-based) or statistical (data-based) approaches, but the first seems more appropriate. Once a few candidate definitions have been selected, their usefulness and prognostic validity can be tested in longitudinal datasets.

Arthritis, Rheumatoid↗
PubMed2003

Outcome variables for osteoarthritis clinical trials: The OMERACT-OARSI set of responder criteria.

Improvement in analysis and reporting results of osteoarthritis (OA) clinical trials has been recently obtained because of harmonization and standardization of the selection of outcome variables (OMERACT 3 and OARSI). Moreover, OARSI has recently proposed the OARSI responder criteria. This composite index permits presentation of results of symptom modifying clinical trials in OA based on individual patient responses (responder yes/no). The 2 organizations (OMERACT and OARSI) established a task force aimed at evaluating: (1) the variability of observed placebo and active treatment effects using the OARSI responder criteria; and (2) the possibility of proposing a simplified set of criteria. The conclusions of the task force were presented and discussed during the OMERACT 6 conference, where a simplified set of responder criteria (OMERACT-OARSI set of criteria) was proposed.

Clinical Trials, Phase III as Topic↗
PubMed2002

Measuring disease activity and functional status in patients with scleroderma and Raynaud's phenomenon.

OBJECTIVE: To document disease activity and functional status in patients with scleroderma (systemic sclerosis [SSc]) and Raynaud's phenomenon (RP) and to determine the sensitivity to change, reliability, ease of use, and validity of various outcome measures in these patients. METHODS: Patients with SSc and moderate-to-severe RP participating in a multicenter RP treatment trial completed daily diaries documenting the frequency and duration of RP attacks and recorded a daily Raynaud's Condition Score (RCS). Mean scores for the 2-week periods prior to baseline (week 0), end of trial (week 6), and posttrial followup (week 12) were calculated. At weeks 0, 6, and 12, physicians completed 3 global assessment scales and performed clinical assessments of digital ulcers and infarcts; patients completed the Health Assessment Questionnaire (HAQ), the Arthritis Impact Measurement Scales 2 (AIMS2) mood and tension subscales, 5 specific SSc/RP-related visual analog scales (VAS), and 3 other VAS global assessments. We used these measures to document baseline disease activity and to assess their construct validity, sensitivity to change, and reliability in trial data. RESULTS: Two hundred eighty-one patients (248 women, 33 men; mean age 50.4 years [range 18-82 years]) from 14 centers participated. Forty-eight percent had limited cutaneous SSc; 52% had diffuse cutaneous SSc. Fifty-nine patients (21%) had digital ulcers at baseline. Patients had 3.89 +/- 2.33 (mean +/- SD) daily RP attacks (range 0.8-14.6), with a duration of 82.1 +/- 91.6 minutes/attack. RCS for RP activity (possible range 0-10) was 4.30 +/- 1.92. HAQ scores (0-3 scale) indicated substantial disability at baseline (total disability 0.86, pain 1.19), especially among the subscales pertaining to hand function (grip, eating, dressing). AIMS2 mood and tension scores were fairly high, as were many of the VAS scores. Patients with digital ulcers had worse RCS, pain, HAQ disability (overall, grip, eating, and dressing), physician's global assessment, and tension, but no significant difference in the frequency of RP, duration of RP, patient's global assessment, or mood, compared with patients without digital ulcers. VAS scores for digital ulcers as rated by the patients were not consistent with the physician's ratings. Factor analysis of the 18 measures showed strong associations among variables in 4 distinct domains: disease activity, RP measures, digital ulcer measures, and mood/tension. Reliability of the RCS, HAQ pain and disability scales, and AIMS2 mood and tension subscales was high. The RP measures demonstrated good sensitivity to change (effect sizes 0.33-0.76). CONCLUSION: Our findings demonstrate that the significant activity, disability, pain, and psychological impact of RP and digital ulcers in SSc can be measured by a small set of valid and reliable outcome measures. These outcome measures provide information beyond the quantitative metrics of RP attacks. We propose a core set of measures for use in clinical trials of RP in SSc patients that includes the RCS, patient and physician VAS ratings of RP activity, a digital ulcer/infarct measure, measures of disability and pain (HAQ), and measures of psychological function (AIMS2).

Affect↗
PubMed2002

Barriers, facilitators, and access for wheelchair users: substantive and methodologic lessons from a pilot study of environmental effects.

We undertook a month-long intensive pilot study of a sample of adult wheelchair-users in Boston, Massachusetts and Durham, North Carolina, USA. The study had four objectives; to: (1) measure experiences of reaching and failing to reach specific destinations; (2) measure encounters with environmental facilitators and barriers, including both those overcome and not overcome; (3) determine the frequencies of destinations, facilitators, and barriers, and (4) test for consistency between daily reports and retrospective reports. Full participation entailed baseline and exit telephone interviews, and 28 daily telephone contacts. Participants reported reaching a wide range of destinations, most notably, banks, stores and shops, friends' and relatives' homes and health professionals' offices. There was a smaller range of destinations that they could not reach, despite trying; most notably, religious buildings, friends' and relatives' homes and work-places. They encountered an array of barriers, some of which they were able to overcome and others they could not overcome. Reported barriers included personal, interpersonal, and environmental barriers. The 25 subjects completing the study reported a wide range of human, environmental, and technologic support. In general, the consistency among daily, baseline, and exit interviews was high. This study has both substantive and methodologic implications. It suggests that efforts to facilitate social participation by wheelchair-users should focus not only on the built environment, but also on interventions in personal assistance and assistive technology, health promotion and fitness, and programs that improve civility. Methodologically, the data suggest that it is possible to make reliable measures of environmental encounters without the administrative and respondent burden associated with daily interviews.

Activities of Daily Living↗
PubMed2002

Diagnostic cost groups (DCGs) and concurrent utilization among patients with substance abuse disorders.

OBJECTIVE: To assess the performance of Diagnostic Cost Groups (DCGs) in explaining variation in concurrent utilization for a defined subgroup, patients with substance abuse (SA) disorders, within the Department of Veterans Affairs (VA). DATA SOURCES: A 60 percent random sample of veterans who used health care services during Fiscal Year (FY) 1997 was obtained from VA administrative databases. Patients with SA disorders (13.3 percent) were identified from primary and secondary ICD-9-CM diagnosis codes. STUDY DESIGN: Concurrent risk adjustment models were fitted and tested using the DCG/HCC model. Three outcome measures were defined: (1) "service days" (the sum of a patient's inpatient and outpatient visit days), (2) mental health/substance abuse (MH/SA) service days, and (3) ambulatory provider encounters. To improve model performance, we ran three DCG/HCC models with additional indicators for patients with SA disorders. DATA COLLECTION: To create a single file of veterans who used health care services in FY 1997, we merged records from all VA inpatient and outpatient files. PRINCIPAL FINDINGS: Adding indicators for patients with mild/moderate SA disorders did not appreciably improve the R-squares for any of the outcome measures. When indicators were added for patients with severe SA who were in the most costly category, the explanatory ability of the models was modestly improved for all three outcomes. CONCLUSIONS: Modifying the DCG/HCC model with additional markers for SA modestly improved homogeneity and model prediction. Because considerable variation still remained after modeling, we conclude that health care systems should evaluate "off-the-shelf" risk adjustment systems before applying them to their own populations.

Adult↗
PubMed2002

Beta 2 microglobulin serum levels and prediction of survival in AL amyloidosis.

To study the relation between beta 2 microglobulin (beta 2M) and survival in AL amyloidosis, we measured the serum level of beta 2M in 80 patients with AL amyloidosis diagnosed within 1 year of evaluation, who had received no therapy. Patients had a median age of 61 years and 52% were male. Major clinical manifestations were renal disease in 25 patients (31%), cardiomyopathy in 23 patients (29%), and neuropathy or other organ involvement in 32 patients (41%). The beta 2M level, measured by an ELISA assay in serum samples collected at the time of evaluation, ranged from 1.69 to 10 mg/ml (mean = 4.57); in 56% of the patients beta 2M > 4 mg/ml. The patients with a beta 2M < or = 4 mg/ml had serum creatinine levels lower than those with beta 2M > 4 (1.43 vs 2.67 mg/dl; p = 0.02). Survival from study entry was analyzed overall by the level of beta 2M, adjusting for creatinine level and clinical stratum. We found the beta 2M level to be predictive of survival (median survival 16.1 months for beta 2M < or = 4 mg/ml vs 8.0 months for beta 2M > 4 mg/ml, p = 0.044). Thus a beta 2M level less than 4 mg/ml indicated a longer time of survival.

Adult↗
PubMed2002

Relative costs and effectiveness of specialist and general internist ambulatory care for patients with 2 chronic musculoskeletal conditions.

OBJECTIVE: To evaluate costs and effectiveness of ambulatory care provided by specialists, nonspecialists (general internists), and both specialists and nonspecialists (co-care) to patients with knee osteoarthritis (OA) and/or chronic low back pain (LBP). METHODS: We studied Veterans Health Administration (VHA) outpatients from the Veterans Health Study with LBP and/or OA followed for at least 6 months between August 1993 and December 1995, who completed the Medical Outcomes Study Short Form 36-item (SF-36) functional status questionnaires at both baseline and followup. We obtained costs of VHA outpatient utilization and medications for these patients during the followup period. We compared costs and effectiveness of the ambulatory care provided by specialists, nonspecialists, and co-care. We also compared specialty care with nonspecialty care using an incremental cost effectiveness ratio (ICER) of annualized cost difference divided by annualized SF-36 based Physical Component Summary (PCS) improvement difference. ICER stability was assessed using bootstrap sampling. RESULTS: Among 398 patients, followed an average of 14 months, 155 received only nonspecialty care, 49 specialty-only care, and 192 co-care. After regression analysis, adjusted for age, disease characteristics, and baseline health status, PCS improvements per year were 1.66 (SD 8.22) for nonspecialty care, 3.48 (SD 7.91) for specialty care, and 0.65 (SD 8.08) for co-care; while costs of care per year were $1099 (SD $1681), $1376 (SD $1503), and $2517 (SD $1644), respectively (all data US dollars). A standardized ICER of $152 per PCS unit indicated specialty care to be cost effective compared with nonspecialty care. CONCLUSION: Specialist-only ambulatory care for OA or LBP was associated with improvement in functional status at slightly higher costs compared with nonspecialty care. Co-care, however, was substantially more costly and was associated with little improvement in functional status.

Adult↗
PubMed2002

Profiling resource use: do different outcomes affect assessments of provider efficiency?

OBJECTIVES: To examine whether 2 outcome measures result in different assessments of efficiency across 22 service networks within the Department of Veterans Affairs (VA). STUDY DESIGN: A retrospective analysis using VA inpatient and outpatient administrative databases. METHODS: A 60% random sample of veterans who used healthcare services during fiscal year 1997 was split into a 40% sample (n = 1,046,803) for development and a 20% sample (n = 524,461) for validation. Weighted concurrent case-mix models using adjusted clinical groups were developed to explain variation in 2 outcomes: "days of care"--the sum of a patient's inpatient and outpatient annual visit days, and "average accounting costs"--the sum of the average service costs multiplied by the units of service for each patient. Two profiling indicators were calculated for each outcome: an unadjusted efficiency index and an adjusted efficiency index. These indices were compared to examine network efficiency. RESULTS: Although about half the networks were identified as "efficient" before and after case-mix adjustment, assessments of individual network efficiency were affected by the adjustment. The 2 outcomes differed on which networks were efficient. For example, 4 networks that appeared as efficient based on days of care appeared as inefficient based on average costs. CONCLUSIONS: Assessments of provider efficiency across the 22 networks depended on the outcome measure used. Knowledge about the extent to which assessments of provider efficiency depend on the outcome measure used is an important step toward improved and more equitable comparisons across providers.

Adult↗