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Cynthia R Gross

Publications and source records attributed to Cynthia R Gross.

15 recordsLinked to original sources

Clinically important drug-disease interactions and their prevalence in older adults.

BACKGROUND: Older adults may have decreased homeostatic reserve, have multiple chronic diseases, and take multiple medications. Therefore, they are at risk for adverse outcomes after receiving a drug that exacerbates a chronic disease. OBJECTIVES: The aims of this study were to compile a list of clinically important drug-disease interactions in older adults, obtain the consensus of a multidisciplinary panel of geriatric health care professionals on these interactions, and determine the prevalence of these interactions in a sample of outpatients. METHODS: This analysis included a 2-round modified Delphi survey and cross-sectional study. Possible drug-disease interactions in patients aged > or =65 years were identified through a search of the English-language literature indexed on MEDLINE and International Pharmaceutical Abstracts (1966-July 2004) using terms that included drug-disease interaction, medication errors, and inappropriate prescribing. Nine health care professionals with expertise in geriatrics (2 geriatricians, 7 geriatric clinical pharmacist specialists) were selected based on specialty training and continuing clinical work in geriatrics, academic appointments, and geographic location. The panel rated the importance of the potential drug-disease interactions using a 5-point Likert scale (from 1 = definitely not serious to 5 = definitely serious). Consensus on a drug-disease interaction was defined as a lower bound of the 95% CI > or =4.0. The prevalence of drug-disease interactions was determined by applying the consensus criteria to a convenience sample of frail older veterans at hospital discharge who were enrolled in a health services intervention trial. RESULTS: The panel reached consensus on 28 individual drug-disease interactions involving 14 diseases or conditions. Overall, 205 (15.3%) of the 1340 veterans in the sample had > or =1 drug-disease interaction. The 2 most common drug-disease interactions were use of first-generation calcium channel blockers in patients with congestive heart failure and use of aspirin in patients with peptic ulcer disease (both, 3.7%). CONCLUSIONS: A survey of multidisciplinary geriatric health care professionals resulted in a concise consensus list of clinically important drug-disease interactions in older adults. Further research is needed to examine the impact of these drug-disease interactions on health outcomes and their applicability as national measures for the prevention of drug-related problems.

Aged↗

Addressing the issue of channeling bias in observational studies with propensity scores analysis.

Randomized Clinical Trials (RCTs) remain the gold standard for determining the utility of pharmaceuticals especially from a safety and efficacy standpoint. However, restrictive entry criteria and stringent protocols can be barriers to generalizing RCT findings to real world practices and outcomes. Observational studies overcome these limitations of RCTs since they are representative of real world populations and practices. Nonetheless, attributing causality remains a major limitation in observational studies, due to the non-random assignment of subjects to treatment. Non-random assignment can lead to imbalances in risk-factors between the groups being compared and thus bias the estimates of the treatment effect. Non-random assignment can be particularly problematic in observational studies comparing older versus newer pharmaceuticals from similar therapeutic classes due to the phenomenon of channeling. Channeling occurs when drug therapies with similar indications are preferentially prescribed to groups of patients with varying baseline prognoses. In this manuscript we discuss the phenomenon of channeling and the use of a statistical technique known an propensity scores analysis which potentially adjusts for the effects of channeling. During the course of this manuscript we discuss tests for determining the quality of the derived propensity score, various techniques for utilizing propensity scores, and also the potential limitations of this technique. With the increasing availability of high quality pharmaceutical and medical claims data for use in observational studies, increased attention must be given to analytic techniques that adjust optimally for non-random assignment and resulting channeling bias. For research studies using observational study designs, propensity score analysis offers a reasonable solution to address the limitation of non-random assignment, especially when RCTs are too costly, time-consuming or not ethically feasible.

Bias↗

Longitudinal impact of mindfulness meditation on illness burden in solid-organ transplant recipients.

BACKGROUND: In 2001, more than 24000 solid-organ transplant surgeries were performed in the United States. Although survival rates have steadily risen over the past 2 decades, transplant recipients commonly experience a myriad of symptoms after transplantation that compromise quality of life. Anxiety, depression, and insomnia frequently occur despite excellent function of the transplanted organ. Use of complementary and alternative medicine has risen sharply over the past 10 years, particularly among people with chronic illnesses. METHODS: Twenty solid-organ transplant recipients were enrolled in a clinical trial of mindfulness-based stress reduction. During the 8-week course, subjects learned various forms of meditation and gentle hatha yoga. Participants were given audiotapes for home practice and maintained practice diaries. Longitudinal analysis focused on the impact of mindfulness-based stress reduction on symptom management, illness intrusion, and transplant-related stressors. RESULTS: Significant improvements in the quality and duration of sleep continued for 6 months after completion of the mindfulness-based stress reduction course. Improvements after the completion of the course were also noted in self-report measures of anxiety and depression. CONCLUSIONS: Mindfulness-based stress reduction is an effective treatment in improving the quality and duration of sleep. Because sleep is highly correlated with positive mental health and overall well-being, these findings suggest that mindfulness-based stress reduction has the potential of being an effective, accessible and low-cost intervention that could significantly change transplant recipients' overall health and well-being.

Adaptation, Psychological↗

Impact of inappropriate drug use on health services utilization among representative older community-dwelling residents.

BACKGROUND: There is limited objective information regarding the impact of drugs identified as inappropriate by drug utilization review (DUR) or the Beers drugs-to-avoid criteria on health service use. OBJECTIVE: The goal of this study was to examine the predictive validity of DUR and the Beers criteria employed to define inappropriate drug use in representative community residents, aged >or=68 years, as determined by the relationship of these criteria to health service use in older community residents. METHODS: Data came from participants in the Duke University Established Populations for Epidemiologic Studies of the Elderly seen in 1989/1990 and for whom information was also available 3 years later. Two sets of inappropriate drug use criteria were examined: (1) DUR regarding dosage, duration, duplication, and drug-drug and drug-disease interactions; and (2) the Beers criteria, applied to drug use reported in an in-home interview. Outpatient visits and nursing-home entry were determined by personal report; hospitalization information came from Medicare Part A files from the Centers for Medicare and Medicaid Services. RESULTS: A total of 3165 participants were available at the fourth interview in 1989/1990. The majority were aged >74 years (51.1%), white (64.8%), women (64.7%), had fair or poor health (77.0%), consistently saw the same physician (86.9%), and possessed supplemental health insurance (62.8%). Use of inappropriate drugs meeting DUR criteria, especially for drug-drug or drug-disease interaction problems, was associated with increased outpatient visits (P<0.05) but not with time to hospitalization or time to nursing home entry. The use of inappropriate drugs according to the Beers criteria was associated with reduced time to hospitalization (adjusted hazard ratio, 1.20; 95% CI, 1.04-1.39) but not to outpatient visits or nursing home entry. CONCLUSIONS: Our data suggest that in representative community residents aged >or=68 years, current criteria for inappropriate drug use should be used with caution in evaluating quality of care because they have minimal impact on use of health services. We found increases only in the use of outpatient services (with DUR) and more rapid use of hospitalization (with the Beers criteria).

Aged↗

Estimation and comparison of derived preference scores from the SF-36 in lung transplant patients.

The purpose of this study was to estimate and compare preference scores derived from MOS Short Form-36 (SF-36) data for a sample of lung transplant patients using three methodologies: Fryback et al. (Med Decis Making 1997; 17: 1-9), Nichol et al. (Med Decis Making 2001; 21: 105-112) and Brazier et al. (J Health Econ 2002: 21: 271-292). Data were gathered from 99 lung transplant recipients using a mail survey, which included the SF-36 and other health-related quality of life (HRQL) measures. The mean preference score for the sample was 0.643 (range 0.43-0.83), 0.765 (range 0.36-1.0), and 0.697 (range 0.33-1.00) for Fryback, Nichol and Brazier methods, respectively. Correlations between the derived scores and visual analogue ratings of health (0.58-0.68) and pulmonary symptoms (-0.59 to -0.62) were moderate to good and in the expected directions. The mean preferences of patients grouped by levels of dyspnea, depression symptoms, illness burden, and self-rated general health differed significantly with all methods and supported the construct validity of the derived scores as measures of preference. The Nichol and Brazier scores, both derived with standard gamble utilities, were generally higher than Fryback scores, which are not utility-based. Given the popularity of the SF-36, these three methods could be useful where direct elicitation of preferences is not feasible. Researchers must be cognizant of the derivation method used, as absolute preference levels, hence quality adjusted life years (QALYs), will differ by method.

Adolescent↗

Mindfulness meditation to reduce symptoms after organ transplant: a pilot study.

CONTEXT: Solid organ transplant patients require life-long immune suppression that can produce distressing side effects and complications. OBJECTIVE: To evaluate the potential of Mindfulness-Based Stress Reduction (MBSR) to reduce symptoms of depression, anxiety, and sleep disturbance and improve quality of life after solid organ transplantation. DESIGN: Longitudinal with evaluations at baseline, postcourse and 3-month follow-up. PARTICIPANTS AND SETTING: Kidney, lung, or pancreas transplant recipients (N=20), aged 35 to 59 years, living in the community. INTERVENTION: An MBSR class (2.5 hours weekly, for 8 weeks), modeled after the program of Jon Kabat-Zinn. Home practice (goal: 45 minutes, 5 days weekly) was monitored. MAIN OUTCOME MEASURES: Self-report scales for depression (CES-D), anxiety (STAI-Y1), and sleep dysfunction (PSQI). RESULTS: Nineteen participants completed the course. Findings suggest improvement from baseline symptom scores for depression (P=.006) and sleep (P=.011) at the completion of the MBSR program. At 3 months, improvement in sleep continued (P=.002), and a significant improvement in anxiety scores was seen (P=.043); scores for both symptoms demonstrated a linear trend and dose-response relationship with practice time. In contrast, depression scores showed a quadratic trend, and at 3 months were no longer different from baseline. A composite symptom measure was significantly improved at 3-month follow-up (P=.007). Global and health-related quality of life ratings were not improved. Effects of group support and instructor attention were not controlled, and sample size and follow-up time were limited. A randomized trial to overcome these shortcomings should be done, as symptom distress in transplant recipients appears responsive to MBSR.

Adult↗

Impact of randomized trial results on acute lung injury ventilator therapy in teaching hospitals.

Reducing tidal volumes administered to patients with acute lung injury is the only intervention reported to decrease mortality resulting from this life-threatening condition. Whereas many medical advances are slowly brought into practice, clinicians in teaching hospitals are often assumed to be early adopters of new medical advances. Our objective was to examine trends in the ventilatory prescription for 398 patients with acute lung injury treated in three teaching hospitals from 1994 to 2001. There was no change in tidal volumes until mid to late 1998, when volumes started to slowly decline at the rate of 48.0 (95% confidence interval, 21.0 to 74.4) ml/year. In the 2 years after the results were released from a large trial that demonstrated the superiority of 6 ml/kg tidal volume therapy over 12 ml/kg, clinicians prescribed tidal volumes of 651 +/- 128 ml or 10.1 +/- 1.9 ml/kg. Tidal volumes after intubation were minimally reduced over the subsequent 2 days of mechanical ventilation (mean reduction, 33 ml). Hospital category, male sex, and disease onset before May 1999 were associated with higher volumes whereas lung injury severity was inversely associated. We conclude that clinicians practicing at these teaching hospitals have not rapidly adopted low tidal volume ventilation that may reduce mortality.

Acute Disease↗

Antiepileptic drug use in nursing home admissions.

Although 1 of 10 nursing home residents is taking an antiepileptic drug (AED), no study to our knowledge has determined whether most residents are already receiving AED treatment when they are admitted or are given these drugs afterward. That differentiation was the focus of this study. The study group consisted of 10,318 residents, 65 years and older, admitted to 510 nursing homes located throughout the United States during the first quarter of 1999. AED prevalence at admission was 7.7%; three fifths had an epilepsy/seizure indication. In a multivariate analysis, factors associated with AED use at admission included epilepsy/seizure, bipolar depression, age group, and cognitive performance. In the follow-up cohort (N = 9,516), postadmission initiation of AEDs was 2.7%; one fifth had an epilepsy/seizure indication. In the multivariate analysis, factors associated with postadmission AED initiation included epilepsy/seizure indication, bipolar depression, age group, peripheral vascular disease, and cognitive performance. This rate of AED postadmission initiation within the first 3 months of admission was much higher than expected, suggesting that new symptoms may develop after admission. Results also show that the rate of AED use in nursing homes is not static.

Aged↗

Concentration-controlled compared with conventional antiretroviral therapy for HIV infection.

OBJECTIVES: To demonstrate the feasibility of a concentration-controlled approach to combination antiretroviral therapy, and to compare the virological responses and safety of this strategy versus conventional fixed-dose therapy. DESIGN: A prospective, randomized, 52 week, open-label trial of concentration-controlled compared with conventional dose zidovudine, lamivudine, and indinavir therapy conduced in a university-based general clinical research center in the United States. PATIENTS: Forty antiretroviral-naive individuals with plasma HIV-RNA levels > 5000 copies/ml. INTERVENTIONS: Zidovudine, lamivudine, and indinavir plasma concentrations were measured in all participants. Doses were adjusted in those assigned to concentration-controlled therapy to achieve levels equal to or greater than target values. MAIN OUTCOME MEASURES: The proportion of patients who achieved the desired drug concentrations, the proportion of patients with HIV-RNA levels < 50 copies/ml at week 52, and safety and tolerance in the concentration-controlled versus conventional therapy arms. RESULTS: Significantly more concentration-controlled recipients achieved the desired concentration targets for all three drugs: 15 of 16 concentration-controlled recipients compared with nine of 17 conventional recipients (P = 0.017) had HIV-RNA levels < 50 copies/ml at week 52. No difference was observed in the occurrence of drug-related clinical events or laboratory abnormalities between the two treatment arms. CONCLUSION: Concentration-controlled therapy implemented simultaneously for three antiretroviral agents was feasible, as well tolerated as conventional therapy, and resulted in a greater proportion of recipients with HIV-RNA levels < 50 copies/ml after 52 weeks. These findings provide a scientific basis to challenge the accepted practice of administering the same dose of antiretroviral agents to all adults, ignoring the concentrations actually achieved.

Adult↗

Use of inappropriate prescription drugs by older people.

OBJECTIVES: To determine the prevalence and predictors of inappropriate drug prescribing defined by expert national consensus panel drug utilization review criteria for community-dwelling older people. DESIGN: Survey. SETTING: Five adjacent urban and rural counties in the Piedmont area of North Carolina. PARTICIPANTS: A stratified random sample of participants from the fourth (n = 3,234) and seventh (n = 2,508) waves of the Duke Established Populations for Epidemiological Studies of the Elderly. MEASUREMENTS: The prescribing appropriateness for digoxin, calcium channel blockers, angiotensin-converting enzyme inhibitors, histamine(2) receptor antagonists, nonsteroidal antiinflammatory drugs (NSAIDs), benzodiazepines, antipsychotics, and antidepressants as determined by explicit criteria (through Health Care Financing Administration expert consensus panel drug utilization review criteria for dosage, duplication, drug-drug interactions and duration, and U.S. and Canadian expert consensus panel criteria for drug-disease interactions). Multivariable analyses, using weighted data adjusted for sampling design, were conducted to assess the association between inappropriate prescribing and demographic, health-status, and access-to-healthcare factors cross-sectionally and longitudinally. RESULTS: We found that 21.0 of the fourth wave and 19.2 of the seventh wave participants who used one or more agents from the eight drug classes had one or more elements identified as inappropriate. The therapeutic classes with the most problems were benzodiazepines and NSAIDs. The most common problems were with drug-disease interactions and duration of use. Longitudinal multivariable analyses found that participants who were white (adjusted odds ratio (AOR) = 1.67, 95 confidence interval (CI) = 1.28-2.17), were married (AOR = 1.40, 95% CI = 1.01-1.93), had arthritis (AOR = 1.74, 95% CI = 1.27-2.38), had one or more physical function disabilities (AOR = 1.42, 95% CI = 1.02-1.96), and had inappropriate drugs prescribed at wave 4 (AOR = 6.87, 95% CI = 5.11-9.22) were more likely to have inappropriate prescribing at wave 7. CONCLUSION: These results indicate that inappropriate prescribing is common among community-dwelling older people and persists over time. Longitudinal studies in older people are needed to examine the impact of inappropriate drug prescribing on health-related outcomes.

Aged↗

Beyond the mean.

Explore the source record for details and available documents.

Health Status↗

Impact of inappropriate drug use on mortality and functional status in representative community dwelling elders.

BACKGROUND: The predictive validity of Drug Utilization Review (DUR) and drugs-to-avoid criteria in elders is unknown. OBJECTIVES: To evaluate the relationship between use of inappropriate drugs as determined by these explicit criteria and mortality and decline in functional status in community dwelling elders. RESEARCH DESIGN: Cohort study. SUBJECTS: The fourth wave (3234 participants) of the Duke Established Populations for Epidemiologic Studies of the Elderly. MEASURES: Two sets of inappropriate drug-use criteria: (1) DUR with respect to dosage, duplication, drug-drug interactions, duration, and drug-disease interactions; and (2) Beers-modified criteria regarding drugs-to-avoid were applied to drug use reported in an in-home interview. Death was identified from the National Death Index; change in four functional status measures (basic self-care, intermediate self-care, complex self-management, physical function) was determined during the following 3 years. RESULTS: Use of inappropriate drugs identified by either set of criteria was not significantly associated with mortality. The drugs-to-avoid criteria identified no significant associations between use of these drugs and decline in functional status. With DUR criteria, however, the association between use of inappropriate drugs and basic self-care was significant and pronounced among those with drug-drug or drug-disease interaction problems (Adj. OR 2.04; 95% CI 1.32-3.16). CONCLUSIONS: Identifying the impact of inappropriate drug use may depend on the criteria applied. Further studies are needed that measure additional outcomes and use alternate measures of inappropriate drug use.

Activities of Daily Living↗

False-positive cancer screens and health-related quality of life.

By design, screening tests are imperfect-unresponsive to some cancers (false negatives) while occasionally raising suspicion of cancer where none exists (false positives). This pilot study describes patients' responses to having a false-positive screening test for cancer, and identifies screening effects on health-related quality of life (HRQoL). The pilot findings suggest issues important for incorporation in future evaluations of the impact of screening for prostate, lung, colon, or ovarian (PLCO) cancers. Seven focus groups were conducted to identify the nature and meaning of all phases of PLCO screening. Minnesota participants in the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial who had completed screening, with at least 1 false-positive screen, participated (N = 47). Participants' reactions to abnormal screens and diagnostic work-ups were primarily emotional (eg, anxiety and distress), not physical, and ultimately positive for the majority. Health distress and fear of cancer and death were the major negative aspects of HRQoL identified. These concepts are not typically included in generic HRQoL questionnaires like the SF-36, but are highly relevant to PLCO screening. Clinicians were regarded as underestimating the discomfort of follow-up diagnostic testing. However, relief and assurance appeared to eventually outweigh the negative emotions for most participants. Implications for oncology nurses include the need to consider the emotional consequences of screening in association with screen reliability and validity.

Aftercare↗

Postpartum health of employed mothers 5 weeks after childbirth.

PURPOSE: Most new mothers return to work soon after childbirth. A need exists to reexamine the definition of postpartum health and evaluate employed women's recovery from childbirth in association with such factors as delivery type and breastfeeding. METHODS: Using a prospective cohort design, we recruited Minnesota women into the study while they were hospitalized for childbirth in 2001. Telephone interviews were conducted 5 weeks postpartum. Eligible women were 18 years or older, employed, and spoke English. Multivariate models using 2-stage least squares were used to estimate factors associated with physical and mental health and postpartum symptoms. RESULTS: A total of 817 women were enrolled (71% response) in the study; 716 women completed interviews at 5 weeks postpartum. On average, women reported 6 postpartum symptoms, most frequently fatigue (64%), breast discomfort (60%), and decreased desire for sex (52%). Findings showed that cesarean (vs vaginal) deliveries were associated with significantly worse physical function, role limitations, and vitality. Multivariate findings showed that the effect of delivery type on physical health was moderately large (beta = -5.96; P = or <.01), and breastfeeding was associated with an increased frequency of postpartum symptoms (beta = 4.63; P = .01). CONCLUSIONS: These mothers experienced several childbirth-related symptoms at 5 weeks postpartum, indicating a need for ongoing rest and recovery. Health concerns were greater for women who were breastfeeding and for those whose babies were delivered by cesarean section, suggesting a need for greater support for these women and a reassessment by the medical community of the progressively growing practice of cesarean deliveries.

Adult↗

Mindfulness meditation to reduce symptoms after organ transplant: a pilot study.

CONTEXT: Solid organ transplant patients require life-long immune suppression that can produce distressing side effects and complications. OBJECTIVE: To evaluate the potential of Mindfulness-Based Stress Reduction (MBSR) to reduce symptoms of depression, anxiety, and sleep disturbance and improve quality of life after solid organ transplantation. DESIGN: Longitudinal with evaluations at baseline, postcourse and 3-month follow-up. PARTICIPANTS AND SETTING: Kidney, lung, or pancreas transplant recipients (N = 20), aged 35 to 59 years, living in the community. INTERVENTION: An MBSR class (2.5 hours weekly, for 8 weeks), modeled after the program of Jon Kabat-Zinn. Home practice (goal: 45 minutes, 5 days weekly) was monitored. MAIN OUTCOME MEASURES: Self-report scales for depression (CES-D), anxiety (STAI-Y1), and sleep dysfunction (PSQI). RESULTS: Nineteen participants completed the course. Findings suggest improvement from baseline symptom scores for depression (P = .006) and sleep (P = .011) at the completion of the MBSR program. At 3 months, improvement in sleep continued (P = .002), and a significant improvement in anxiety scores was seen (P = .043); scores for both symptoms demonstrated a linear trend and dose-response relationship with practice time. In contrast, depression scores showed a quadratic trend, and at 3 months were no longer different from baseline. A composite symptom measure was significantly improved at 3-month follow-up (P = .007). Global and health-related quality of life ratings were not improved. Effects of group support and instructor attention were not controlled, and sample size and follow-up time were limited. A randomized trial to overcome these shortcomings should be done, as symptom distress in transplant recipients appears responsive to MBSR.

Adult↗