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Lori Davis

Publications and source records attributed to Lori Davis.

15 recordsLinked to original sources

Effect of multivitamin and mineral supplementation on episodes of infection in nursing home residents: a randomized, placebo-controlled study.

OBJECTIVES: To evaluate the effect of vitamin and mineral supplementation on infections in an elderly institutionalized population. DESIGN: Eighteen-month, randomized, placebo-controlled trial. SETTING: Twenty-one long-term care facilities. PARTICIPANTS: Seven hundred sixty-three subjects from 21 long-term care facilities. INTERVENTION: Participants were randomized to receive one multivitamin and mineral supplementation daily or placebo. MEASUREMENTS: The primary outcome was number of infections per subject. Secondary outcomes were antibiotic use and hospitalization rates. Infection control surveillance was conducted over 18 months using standardized criteria. RESULTS: Outcome data from 748 subjects, mean age 85, were included in the intention-to-treat analysis. Using univariate analyses, there was no difference in infectious episodes between the supplemented and placebo groups (3.5 infections per 1,000 resident-days vs 3.8 infections per 1,000 resident-days, odds ratio (OR)=0.92, 95% confidence interval (CI)=0.82-1.03, P=.12). There was a reduction in antibiotic usage in the supplementation group, but this was not significant in the multivariate model. There was no difference in the number of hospital visits. In the multivariate analysis, the effect of multivitamin use on total number of infections was not significant (OR=0.77, 95% CI=0.54-1.1). Subjects without dementia had a greater rate of infections than those with dementia (OR=1.44, 95% CI=1.19-1.76). In post hoc subgroup analysis, subjects without dementia who received supplementation had a significantly lower rate of infections than those who received placebo (relative risk=0.81, 95% CI=0.66-0.99). CONCLUSION: Overall, multivitamin and mineral supplementation does not have a significant effect on the incidence of infections in institutionalized seniors, although the subgroup of residents in long-term care without dementia may benefit from supplementation. Further research is needed to determine its effect in high-risk subgroups within the nursing home population.

Aged↗

Enrolling research subjects from clinical practice: ethical and procedural issues in the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial.

The Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial is a multi-site effectiveness study funded by the National Institute of Mental Health (NIMH) with the aim of identifying successful, acceptable and cost-effective treatment strategies for outpatients with unremitted depression. With enrollment of 4,041 adults with major depressive disorder (MDD), it is the largest controlled psychiatric treatment study ever undertaken. In the course of developing procedures to ensure that ambitious enrollment goals were met, a number of ethical and practical issues became apparent that underscore the conflicts between effectiveness research and human subject protections. These are delineated as they relate to study design; eligibility criteria; incentives to subjects; investigators and clinical sites; the complementary roles of clinical research coordinators (CRCs) and study clinicians; and recruitment and consent procedures. The STAR*D trial exemplifies the interplay and tension between those strategies that integrate research and clinical aims and roles in the service of enhancing external validity, site participation, and recruitment and retention versus those strategies that differentiate research and clinical treatment in the service of research integrity and human subject protections. We hope that a discussion of these key challenges and dilemmas and how they have been addressed will help inform future discussions concerning design and conduct of ethical effectiveness trials designed to optimize care in real world clinical settings.

Adolescent↗

Tranylcypromine versus venlafaxine plus mirtazapine following three failed antidepressant medication trials for depression: a STAR*D report.

OBJECTIVE: The purpose of this study was to compare the effectiveness and tolerability of tranylcypromine and combination treatment with extended-release venlafaxine and mirtazapine in patients with treatment-resistant major depression whose current depressive episode had not responded adequately to treatment in three prior prospective medication trials. METHOD: Adult outpatients with nonpsychotic major depressive disorder who had not achieved remission or had withdrawn from treatment because of intolerance in three previous prospective medication trials were randomly assigned to receive open-label treatment with either tranylcypromine (N=58) or extended-release venlafaxine plus mirtazapine (N=51). The primary outcome measure was whether patients achieved remission, which was defined as a score < or =7 at exit on the 17-item Hamilton Depression Rating Scale (HAM-D). The HAM-D was administered by telephone by raters to whom treatment was masked. RESULTS: Remission rates were not significantly different between the two treatment groups (6.9% for the tranylcypromine group and 13.7% for the venlafaxine plus mirtazapine group). The mean daily dose at exit for tranylcypromine was 36.9 mg (SD=18.5); for venlafaxine, 210.3 mg (SD=95.2); and for mirtazapine, 35.7 mg (SD=17.6). Tranylcypromine was associated with significantly less symptom reduction and greater attrition due to intolerance. CONCLUSIONS: Remission rates were modest for both the tranylcypromine group and the extended-release venlafaxine plus mirtazapine group, and the rates were not statistically different between groups. The lower side effect burden, lack of dietary restrictions, and ease of use of venlafaxine and mirtazapine suggest that this combination may be preferred over tranylcypromine for patients with highly treatment-resistant depression who have not benefited adequately from several prior treatments.

Adult↗

Pain flare following external beam radiotherapy and meaningful change in pain scores in the treatment of bone metastases.

BACKGROUND AND PURPOSE: To examine the incidence of pain flare following external beam radiotherapy and to determine what constitutes a meaningful change in pain scores in the treatment of bone metastases. PATIENTS AND METHODS: Patients with bone metastases treated with external beam radiotherapy were asked to score their pain on a scale of 0-10 before the treatment (baseline), daily during the treatment and for 10 days after completion of external beam radiation. Pain flare was defined as a two-point increase from baseline pain in the pain scale of 0-10 with no decrease in analgesic intake or a 25% increase in analgesic intake employing daily oral morphine equivalent with no decrease in pain score. To distinguish pain flare from progression of pain, we required the pain score and analgesic intake to return back to baseline levels after the increase/flare. They were also asked to indicate if their pain changed during that time compared to pre-treatment level. The change in pain score was compared with patient perception. RESULTS: Eighty-eight patients were evaluated in this study. There were 49 male and 39 female patients with the median age of 70 years. Twelve of 88 patients (14%) had pain flare on day 1. The overall incidence of pain flare during the study period ranged from 2 to 16%. A total of 797 pain scorings were obtained. Patients perceived an improvement in pain when their self-reported pain score decreased by at least two points. CONCLUSIONS: Our study confirms the occurrence of pain flare following the external beam radiotherapy in the treatment of bone metastases. Further studies are required to predict who are at risk for flare. Appropriate measures can be taken to alleviate the pain flare. The finding in the meaningful change in pain scores supports the investigator-defined partial response used in some clinical trials.

Adult↗

Accuracy of survival prediction by palliative radiation oncologists.

PURPOSE: To examine the accuracy of survival prediction by palliative radiation oncologists. METHODS AND MATERIALS: After consultation of cancer patients with metastatic disease for referral of palliative radiotherapy, radiation oncologists estimated the survival of the patients. These were compared with the actual dates of death obtained from the Cancer Death Registry. The time to death from all causes was the outcome. The survival times were measured from the date of the first consultation at the palliative radiotherapy clinics. RESULTS: Six radiation oncologists provided estimates for 739 patients. Of the 739 patients, 396 were men and 343 were women (median age, 69 years). The median survival of all patients was 15.9 weeks. The mean difference between the actual survival (AS) and the clinician predicted survival (i.e., actual survival minus clinician predicted survival) was -12.3 weeks (95% confidence interval, -15.0 to -9.5) for the entire population. The mean difference was -21.9 weeks when the actual survival was < or =12 weeks, -19.2 weeks when the AS was 13-26 weeks, -9.7 weeks when the AS was 27-52 weeks, and +23.0 weeks when the AS was >52 weeks. CONCLUSION: In this study, the prediction of survival by radiation oncologists was inaccurate and tended to be overly optimistic.

Adult↗

Effectiveness of computer-based dysphagia training for direct patient care staff.

Speech-language pathologists (SLPs) in medical settings are responsible for evaluating patients' feeding and swallowing. Once an evaluation is completed, nursing staff typically provides hands-on care and supervision of meals. SLPs seek to improve outcomes for individuals with dysphagia by educating direct-care staff. This project sought to determine whether a computer-based swallowing safety module could produce changes in knowledge levels of nursing staff. This module was designed to replace inservices conducted by staff SLPs. Nursing staff would be required to complete the training when hired and as an annual assessment. The training module was designed and pilot-tested along with a pre- and posttest to assess changes in knowledge. Participants in the experimental group took the pretest, completed the computer training module, and then took the posttest. Participants in the control group took the pre- and posttest with no intervening training. Statistically significant differences were found between the two groups on posttest scores. Participants in the experimental group demonstrated increased test scores, while the scores of the control group did not change significantly. This study indicates that computer-based training for nursing staff related to swallowing safety and dysphagia is effective.

Computer-Assisted Instruction↗

Prospective assessment of patient-rated symptoms following whole brain radiotherapy for brain metastases.

To prospectively assess patient-rated symptoms in patients with brain metastases treated with whole brain radiotherapy, these patients were asked to rate their symptoms on the Edmonton Symptom Assessment Scale (ESAS) before, and 1, 2, 4, 8, and 12 weeks following the radiation treatment. ESAS evaluates pain, fatigue, nausea, depression, anxiety, drowsiness, appetite, sense of well-being, and shortness of breath on a scale of 0-10 (0=absence of symptom and 10=worst possible symptom). Patients with a language barrier or significant cognitive impairment were excluded. The mean difference of ESAS symptoms at each follow up were compared with baseline and P < 0.01 was considered statistically significant. One hundred seventy patients (102 female and 68 male) were included between January 1999 and January 2002. Their median age was 66 years (range 33-84) and the median Karnofsky performance score (KPS) at baseline was 60 (range 20-90). The most common primary cancer sites were lung (99; 58%), breast (32; 19%), gastrointestinal (16; 9%), unknown (14; 8%) and others (9; 6%). One-third had significant weight loss (> or =10% over the last 6 months). All patients were prescribed dexamethasone at varying doses during radiotherapy. The dose fractionations were 20 Gy in 5 fractions, 138 (81%); 30 Gy in 10 fractions, 7 (4%); and others, 25 (15%). The baseline mean +/- SD for ESAS scores were: pain 2.4 +/- 2.8, fatigue 5.3 +/- 2.8, nausea 1.3 +/- 2.2, depression 2.8 +/- 2.7, anxiety 3.6 +/- 3.0, drowsiness 3.5 +/- 2.9, appetite 3.0 +/- 3.2, sense of well-being 3.8 +/- 2.7, and shortness of breath 2.3 +/- 2.5. For the entire cohort, after the delivery of palliative radiotherapy for brain metastases, there were statistically significant deteriorations in the mean differences from the baseline for the following ESAS domains: fatigue 1.0 to 1.8; drowsiness 1.2 to 1.8; and appetite 2.2 to 2.4. The data demonstrate that certain parameters of quality of life worsen after whole brain radiotherapy.

Adult↗

Symptom distress in patients attending an outpatient palliative radiotherapy clinic.

Patients with advanced cancer are often polysymptomatic. Different symptoms occur with varying frequency, intensity, and impact. Despite the high prevalence of symptoms in this population, reports of symptomatology in palliative outpatients have been limited. We report the symptom distress in metastatic cancer patients attending an outpatient palliative radiotherapy clinic. Patients referred for palliative radiotherapy for symptom control to the Rapid Response Radiotherapy Program (RRRP) were asked to rate symptom distress using the Edmonton Symptom Assessment Scale (ESAS) at the time of initial consultation. Patient demographics, cancer history, disease status, and analgesic consumption during the previous 24 hours were recorded. Between January 1999 and January 2002, 1,296 patients were seen at the RRRP and consented to participate in the study. Mean symptom distress rates ranged from 1.41 to 5.04. Fatigue, poor sense of well-being, pain, and poor appetite were the highest scored symptoms consecutively. Patients with poorer performance status (KPS < or = 60) had significantly higher symptom distress scores for all nine symptoms (P < 0.001). We conclude that the symptoms of metastatic cancer, including pain, fatigue, depression, anxiety, drowsiness, poor appetite, and sense of well-being, are common among patients attending outpatient palliative clinics. Symptom assessment tools, such as the ESAS, allow for the identification of symptoms and their severity. The appropriate regimen for management of pain and symptoms in metastatic cancer patients can then be planned.

Adult↗

Review of telephone follow-up experience at the Rapid Response Radiotherapy Program.

PURPOSE: To review the feasibility of telephone follow-up following a 3-year experience from 1999 to 2001 at the Rapid Response Radiotherapy Program as a prospective radiotherapy outcome assessment of symptom palliation. METHODS AND MATERIALS: Patients referred for palliative radiotherapy for symptom control from 1999 to 2001 were asked to rate symptom distress using the Edmonton Symptom Assessment System (ESAS) at initial consultation. Patient demographics and analgesic consumption were recorded. Telephone follow-up interviews were conducted with all patients who received radiotherapy during weeks 1, 2, 4, 8, and 12 after radiotherapy using the ESAS and an analgesic diary. Clinic follow-up visits were conducted only if necessary. RESULTS: Between January 1999 and December 2001, 830 patients received palliative radiotherapy. Of these patients, 260 (31.3%) died during the 12-week follow-up period. The percentage of surviving patients responding to the telephone interview ranged from 48.2% (week 12) to 56.6% (week 4) during the 12-week study. CONCLUSION: Telephone follow-up is a feasible tool for prospective outcome assessment of symptom palliation in metastatic cancer patients. Telephone follow-up is recommended for outcome assessment of symptom relief when it can achieve the same purpose as clinic follow-up. Data collection remains a challenge in the palliative patient population. Further studies are required to determine how well other methods of maximizing data collection, such as through the use of caregivers, can provide reliable and accurate information.

Adult↗

Effectiveness and cost of olanzapine and haloperidol in the treatment of schizophrenia: a randomized controlled trial.

CONTEXT: Although olanzapine has been widely adopted as a treatment of choice for schizophrenia, its long-term effectiveness and costs have not been evaluated in a controlled trial in comparison with a standard antipsychotic drug. OBJECTIVE: To evaluate the effectiveness and cost impact of olanzapine compared with haloperidol in the treatment of schizophrenia. DESIGN AND SETTING: Double-blind, randomized controlled trial with randomization conducted between June 1998 and June 2000 at 17 US Department of Veterans Affairs medical centers. PARTICIPANTS: Three hundred nine patients with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition diagnosis of schizophrenia or schizoaffective disorder, serious symptoms, and serious dysfunction for the previous 2 years. Fifty-nine percent fully completed and 36% partially completed follow-up assessments. INTERVENTIONS: Patients were randomly assigned to receive flexibly dosed olanzapine, 5 to 20 mg/d, with prophylactic benztropine, 1 to 4 mg/d (n = 159); or haloperidol, 5 to 20 mg/d (n = 150), for 12 months. MAIN OUTCOME MEASURES: Standardized measures of symptoms, quality of life, neurocognitive status, and adverse effects of medication. Veterans Affairs administrative data and interviews concerning non-VA service use were used to estimate costs from the perspective of the VA health care system and society as a whole (ie, consumption of all resources on behalf of these patients). RESULTS: There were no significant differences between groups in study retention; positive, negative, or total symptoms of schizophrenia; quality of life; or extrapyramidal symptoms. Olanzapine was associated with reduced akathisia in the intention-to-treat analysis (P<.001) and with lower symptoms of tardive dyskinesia in a secondary analysis including only observations during blinded treatment with study drug. Small but significant advantages were also observed on measures of memory and motor function. Olanzapine was also associated with more frequent reports of weight gain and significantly greater VA costs, ranging from 3000 dollars to 9000 dollars annually. Differences in societal costs were somewhat smaller and were not significant. CONCLUSION: Olanzapine does not demonstrate advantages compared with haloperidol (in combination with prophylactic benztropine) in compliance, symptoms, extrapyramidal symptoms, or overall quality of life, and its benefits in reducing akathisia and improving cognition must be balanced with the problems of weight gain and higher cost.

Adult↗

Early intervention with traumatized children.

With the events of September 11th, childhood trauma has come to the forefront of national attention. One of the common psychiatric outcomes of trauma is Posttraumatic Stress Disorder (PTSD). Despite the fact that certain vulnerabilities may contribute to the development of PTSD in traumatized youth, the existence of an identifiable stressor provides a unique opportunity for early intervention. Cognitive Behavioral Treatment (CBT) interventions are considered by many to be the mainstay of treatment of children and adolescents with PTSD. More severe cases of PTSD are often treated with medications in the community. In this article we present a CBT program--developed by our site--STAIR--and provide useful guides and rationales for clinicians to work with when treating this population. We will also briefly review the available literature on the psychopharmacologic interventions to help guide the physician when confronted with such treatment decisions.

Adaptation, Psychological↗

Evaluation of the effectiveness of two clinical training procedures to elicit yes/no responses from patients with a severe acquired brain injury: a randomized single-subject design.

PRIMARY OBJECTIVE: Thirteen (10 males) participants with severe acquired brain injuries (ABI) were randomly assigned to two treatments, A or B (ABAB, BABA) in a crossover study to determine which treatment approach elicited more consistent and reliable yes/no responses. RESEARCH DESIGN: Treatment A consisted of an enriched stimulus environment, collaborative multidisciplinary interventions and additional yes/no response training, while Treatment B consisted of the standard hospital environment and interventions. MAIN OUTCOMES: An ANOVA showed no order effect (AB vs BA; p=0.60), but a trend (A vs B;p=0.07) towards statistical significance for increased responsiveness with treatment A. Inter-raterreliability (n=10) ranged from fair-to-good, intra class correlation (ICC) 0.51; 95% confidence interval (CI) (0.29-0.93). Post-hoc analyses showed statistically significant increased responsiveness for four participants with treatment A (p<0.001). CONCLUSION: Evidence is provided that enhanced communication strategies can improve responsiveness in a sub-group of participants with severe acquired brain injuries.

Adolescent↗

Prevalence of posttraumatic stress disorder in Veterans Affairs primary care clinics.

Although posttraumatic stress disorder (PTSD) is relatively common in community epidemiologic surveys (5-6% for men, 10-12% for women), and psychiatric patients with PTSD are known to have poor functioning and high levels of psychiatric comorbidity, there are no studies that address PTSD prevalence, functioning, and burden in primary care settings. This article reports on (1) the prevalence of PTSD using Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition diagnostic criteria in Veterans Affairs (VA) primary care settings, (2) associated sociodemographic characteristics and comorbidities, (3) functional status related to PTSD, (4) the extent to which PTSD was recognized by providers and (5) health services use patterns (including specialty mental health) of PTSD patients. Patients were randomly selected from those who had an outpatient visit in FY 1999 at one of four VA hospitals; 888 patients consented (74.1% of 1198 contacted); 746 patients (84.0% of consenting patients; 62.3% of contacted patients) were reached for telephone diagnostic interviews. Diagnostic interviews with the Clinician Administered PTSD Scale yielded estimates of current PTSD prevalence of 11.5%. At statistically significant levels, PTSD was positively associated with a variety of comorbid psychiatric disorders, war zone service, age <65 years, not working, less formal education and decreased functioning. Of patients diagnosed with PTSD by study procedures, 12-month medical record review indicated that providers identified only 46.5% and only 47.7% had used mental health specialty services. PTSD-positive [PTSD(+)] patients who used mental health care in the past 12 months were more apt to be identified as having PTSD than nonmental health service users (78.0% vs. 17.8%). Although PTSD(+) patients had more medical record diagnoses than PTSD-negative [PTSD(-)] patients (6.28 vs. 4.95), their use of primary care, urgent care and inpatient care was not different from PTSD(-) patients.

Adolescent↗