nils-herrmann/clean_scirepeval huggingface dataset:
The cost-effectiveness of a family meetings intervention to prevent depression and anxiety in family caregivers of patients with dementia: a randomized trial

Dementia imposes a heavy burden on health and social care systems as well as on family caregivers who provide a substantial portion of the care. Interventions that effectively support caregivers may prevent or delay patient institutionalization and hence be cost-effective. However, evidence about the cost-effectiveness of such interventions is scarce. The aim of this study was to evaluate the cost-effectiveness of a family meetings intervention for family caregivers of dementia patients in comparison with usual care over a period of 12 months.



The economic evaluation was conducted from a societal perspective alongside a randomized trial of 192 primary caregivers with community-dwelling dementia patients. Outcome measures included the Quality Adjusted Life-Years (QALY) of caregivers and patients and the incidence of depression and anxiety disorders in caregivers. Missing cost and effect data were imputed using multiple imputations. Bootstrapping was used to estimate uncertainty around the cost-differences and the incremental cost-effectiveness ratio (ICER). The bootstrapped cost-effect pairs were plotted on a cost-effectiveness plane and used to estimate cost-effectiveness curves.



No significant differences in costs and effects between the groups were found. At 12 months, total costs per patient and primary caregiver dyad were substantial: €77,832 for the intervention group and €75,201 for the usual care group (adjusted mean difference per dyad €4,149, 95% CI -13,371 to 21,956, ICER 157,534). The main cost driver was informal care (66% of total costs), followed by patients' day treatment and costs of hospital and long-term care facility admissions (23%). Based on the cost-effectiveness acceptability curves, the maximum probability that the intervention was considered cost-effective in comparison with usual care reached 0.4 for the outcome QALY per patient-caregiver dyad and 0.6 for the caregivers' incidence of depression and/or anxiety disorders regardless of the willingness to pay.



The annual costs of caring for a person with dementia were substantial with informal care being by far the largest contributor to the total societal costs. Based on this study, family meetings cannot be considered a cost-effective intervention strategy in comparison with usual care.
Lack of absorption of didanosine after rectal administration in human immunodeficiency virus-infected patients.

The feasibility of rectal administration of didanosine (DDI) was studied in six human immunodeficiency virus-infected patients. After oral intake of a DDI solution (100 mg/m2 of body surface area) combined with an antacid (Maalox), pharmacokinetic parametric values were in accordance with previously published data; the mean +/- standard deviation for terminal half-life was 59.5 +/- 15.0 min, that for peak concentration was 5.2 +/- 3.9 mumol/liter, and that for the area under the time-concentration curve (AUC) was 494 +/- 412 min.mumol/liter. After rectal administration of a similarly prepared DDI solution (100 mg/m2 of body surface area), plasma DDI levels were below the detection limit (0.1 mumol/liter) at all time points in five of the six patients, and in the remaining patient the AUC after rectal application was only 5% of that after oral administration. We conclude that oral administration of DDI cannot be easily replaced by rectal application.
Effects of improved fat content of frankfurters and pâtés on lipid and lipoprotein profile of volunteers at increased cardiovascular risk: a placebo-controlled study.

To study the effect of modified frankfurters and pâtés: (a) reduced-fat products (RF) (15.3 and 15.2 % fat, respectively); (b) n-3-enriched reduced-fat products (n-3 RF) (15.1 and 15.5 % fat, respectively); and (c) normal-fat products (NF) (18 and 30.8 % fat, respectively) on lipids, lipoproteins, atherogenic ratios, oxidized LDL, and blood pressure of volunteers at high CVD risk.



Twenty-two volunteers were enrolled in a sequential study of 3 consecutive 4-week periods separated by 4-week washout periods.



LDL-cholesterol (p < 0.01), oxidized LDL, LDL-cholesterol/HDL-cholesterol (both p < 0.05) were significantly affected by the overall intervention. Compared to baseline, LDL-cholesterol decreased significantly (p = 0.012) during the RF period; the LDL-cholesterol/HDL-cholesterol ratio (p = 0.08) and the diastolic blood pressure (p = 0.06) also decreased, although non-significantly, after RF consumption. LDL-cholesterol (p = 0.040) and oxidized LDL (p = 0.016) increased significantly after NF product consumption; systolic blood pressure did not show significant variations after this period. No significant differences, in absolute or relative changes, were observed between RF and n-3 RF consumption for any parameter tested. However, LDL-cholesterol, oxidized LDL, and the LDL-cholesterol/HDL-cholesterol ratio were lower (12, 15 and 10 %, respectively) after n-3 RF versus NF product consumption. Oxidized LDL was approximately 15 % lower after RF versus NF product consumption.



The regular consumption of RF meat products, enriched in n-3 fatty acids or not, positively affects the lipoprotein profile of volunteers, decreasing LDL-cholesterol and oxidized LDL levels and, thus, future risk of cardiovascular accident. On comparison with the effects of NF product intake, the responses to n-3 RF and RF products differ, and while n-3 RF intake induces a reduction in LDL-cholesterol, oxidized LDL-cholesterol, and LDL-cholesterol/HDL-cholesterol ratio, the intake of RF products modifies only the oxidized LDL level.
Palifermin reduces incidence and severity of oral mucositis in allogeneic stem-cell transplant recipients

In this multicenter study, 30 patients undergoing matched related or unrelated allogeneic stem-cell transplantation for leukemia were treated with palifermin, and retrospectively compared to a matched control group. Palifermin recipients transplanted with an unrelated donor showed a significant reduction of severity, incidence and duration of oral mucositis WHO grades 2–4. In addition, in the palifermin group the use of opioid analgesics and the duration of total parenteral nutrition decreased, whether stem cells were used from matched related or unrelated donors. No beneficial influence of palifermin on the incidence and severity of acute GVHD (aGVHD) was apparent. The incidence and duration of febrile neutropenia, documented infections, hematopoietic recovery or overall survival remained unchanged. The most common adverse effects included rash or erythema, generally mild and transient in appearance. Thus, the administration of palifermin was generally well tolerated and safe, and significantly reduced oral mucositis whereas—regardless of donor status—no effect on the incidence and severity of aGVHD was seen.
Diet-Related Colorectal Cancer Prevention Beliefs and Dietary Intakes in an Urban Minority Population

In the United States, colorectal cancer (CRC) is the third leading cause of cancer-related death and third most commonly diagnosed cancer among adults. This study is the first to examine the relationship between diet-related beliefs for colorectal cancer prevention and dietary intake among an urban, predominantly Black population (n = 169). More than two-thirds reported diet-related CRC prevention beliefs. Those with diet-related CRC prevention beliefs had healthier intakes for dietary fiber (p = .005), fruit, vegetable, bean (p = .027), red meat (p = .032), vitamin C (p = .039), and cholesterol (p = .045). Most people may already have diet-related CRC prevention beliefs and having them is associated with a more healthful dietary intake.
Long-term effects of negotiated treatment plans on self-management behaviors and satisfaction with care among women with asthma.

To examine characteristics of women with negotiated treatment plans, factors that contribute to newly forming a treatment plan, and the impact of plans on asthma management, and their satisfaction with care over 2 years.



Data came from telephone interviews with 324 women with asthma at baseline, 12 and 24 months. The effect of having a negotiated treatment plan on medication adherence, asking the physician questions about asthma, asthma management self-efficacy, and satisfaction with care was assessed over 24 months. Data were analyzed using mixed models. Analyses controlled for patient characteristics.



Thirty-eight percent of participants reported having a negotiated treatment plan at three time points. Seeing an asthma specialist (χ(2)(1) = 24.07, p < .001), was associated with having a plan. Women who did not have a negotiated treatment plan at baseline, but acquired one at 12 or 24 months, were more likely to report greater urgent office visits for asthma (odds ratio (OR) = 1.37, 95% confidence interval (CI) = 1.07-1.61). No associations were observed between having a plan and urgent healthcare use or symptom frequency. When adjusting for household income, level of asthma control, and specialty of the caregiving provider, women who did not have a negotiated treatment plan (OR = 0.28, 95% CI = 0.09-0.79) and those with a plan at fewer than three time points (OR = 0.30, 95% CI = 0.11-0.83) were less likely to report medication adherence and satisfaction with their care (regression coefficient (standard error) = -0.65 (0.17), p < .001). No differences in asthma management self-efficacy or asking the doctor questions about asthma were observed.



Women with asthma who had a negotiated treatment plan were more likely to see an asthma specialist. In the long-term, not having a treatment plan that is developed in partnership with a clinician may have an adverse impact on medication use and patient views of clinical services.
Protocol for the RT Prepare Trial: a multiple-baseline study of radiation therapists delivering education and support to women with breast cancer who are referred for radiotherapy

There is limited evidence to guide the preparation of patients for radiotherapy. This paper describes the protocol for an evaluation of a radiation therapist led education intervention delivered to patients with breast cancer in order to reduce psychological distress.



A multiple-baseline study is being used. Usual care data is being collected prior to the start of the intervention at each of three sites. The intervention is delivered by radiation therapists consulting with patients prior to their treatment planning and on the first day of treatment. The intervention focuses on providing sensory and procedural information to patients and reducing pretreatment anxiety. Recruitment is occurring in three states in Australia. Eligible participants are patients who have been referred for radiotherapy to treat breast cancer. 200 patients will be recruited during a usual care phase and, thereafter, 200 patients in the intervention phase. Measures will be collected on four occasions-after meeting with their radiation oncologist, prior to treatment planning, on the first day of treatment and after treatment completion. The primary hypothesis is that patients who receive the radiotherapy preparatory intervention will report a significantly greater decrease in psychological distress from baseline to prior to radiotherapy treatment planning in comparison with the usual care group. Secondary outcome measures include concerns about radiotherapy, patient knowledge of radiotherapy, patient preparedness and quality of life. Patient health system usage and costs will also be measured. Multilevel mixed effects regression models will be applied to test for intervention effects.


ETHICS
Ethics approval has been gained from Curtin University and the three recruiting sites.



Results will be reported in international peer reviewed journals.
LITEWORP: a lightweight countermeasure for the wormhole attack in multihop wireless networks

In multihop wireless systems, such as ad-hoc and sensor networks, the need for cooperation among nodes to relay each other's packets exposes them to a wide range of security attacks. A particularly devastating attack is known as the wormhole attack, where a malicious node records control and data traffic at one location and tunnels it to a colluding node, which replays it locally. This can have an adverse effect in route establishment by preventing nodes from discovering routes that are more than two hops away. In this paper, we present a lightweight countermeasure for the wormhole attack, called LITEWORP, which does not require specialized hardware. LITEWORP is particularly suitable for resource-constrained multihop wireless networks, such as sensor networks. Our solution allows detection of the wormhole, followed by isolation of the malicious nodes. Simulation results show that every wormhole is detected and isolated within a very short period of time over a large range of scenarios. The results also show that the fraction of packets lost due to the wormhole when LITEWORP is applied is negligible compared to the loss encountered when the method is not applied.
Tandem measurement of D-dimer and myeloperoxidase or C-reactive protein to effectively screen for pulmonary embolism in the emergency department.

The hypothesis was that the tandem measurement of D-dimer and myeloperoxidase (MPO) or C-reactive protein (CRP) could significantly decrease unnecessary pulmonary vascular imaging in emergency department (ED) patients evaluated for pulmonary embolism (PE) compared to D-dimer alone.



The authors measured the sequential combinations of D-dimer and MPO and D-dimer and CRP in a prospective sample of ED patients evaluated for PE at two centers. Patients were followed for 90 days for venous thromboembolism (VTE, either PE or deep venous thrombosis [DVT]), which required the consensus of two of three blinded physician reviewers.



The authors enrolled 304 patients, 22 with VTE (7%; 95% confidence interval [CI] = 5% to 10%). The sensitivity and specificity of a D-dimer alone (cutoff > or = 500 ng/mL) were 100% (95% CI = 85% to 100%) and 59% (95% CI = 53% to 65%), respectively, and was followed by pulmonary vascular imaging negative for PE in 38% (115/304; 95% CI = 32% to 44%). The combination of either a negative D-dimer, or MPO < 22 mg/dL, had a sensitivity of 100% and specificity of 73% (95% CI = 67% to 78%). Thus, tandem measurement of D-dimer and MPO would have decreased the frequency of subsequent negative pulmonary vascular imaging from 38% to 25% (95% CI of the difference of -13% = -5% to -20%). The combination of CRP and D-dimer would not have significantly improved the rate of negative imaging.



The tandem measurement of D-dimer and MPO would have significantly decreased negative pulmonary vascular imaging compared with D-dimer alone and should be validated prospectively.
Approaches for classifying the indications for colonoscopy using detailed clinical data

Accurate indication classification is critical for obtaining unbiased estimates of colonoscopy effectiveness and quality improvement efforts, but there is a dearth of published systematic classification approaches. The objective of this study was to evaluate the effects of data-source and adjudication on indication classification and on estimates of the effectiveness of screening colonoscopy on late-stage colorectal cancer diagnosis risk. This was an observational study in members of four U.S. health plans. Eligible persons (n = 1039) were age 55–85 and had been enrolled for 5 years or longer in their health plans during 2006–2008. Patients were selected based on late-stage colorectal cancer diagnosis in a case–control design; each case patient was matched to 1–2 controls by study site, age, sex, and health plan enrollment duration. Reasons for colonoscopies received in the 10-year period before the reference date were collected from three medical records sources (progress notes; referral notes; procedure reports) and categorized using an algorithm, with committee adjudication of some tests. We evaluated indication classification concordance before and after adjudication and used logistic regressions with the Wald Chi-square test to compare estimates of the effects of screening colonoscopy on late-stage colorectal cancer diagnosis risk for each of our data sources to the adjudicated indication. Classification agreement between each data-source and adjudication was 78.8-94.0% (weighted kappa = 0.53-0.72); the highest agreement (weighted kappa = 0.86-0.88) was when information from all data sources was considered together. The choice of data-source influenced the association between screening colonoscopy and late-stage colorectal cancer diagnosis; estimates based on progress notes were closest to those based on the adjudicated indication (% difference in regression coefficients = 2.4%, p-value = 0.98), as compared to estimates from only referral notes (% difference in coefficients = 34.9%, p-value = 0.12) or procedure reports (% difference in coefficients = 27.4%, p-value = 0.23). There was no single gold-standard source of information in medical records. The estimates of colonoscopy effectiveness from progress notes alone were the closest to estimates using adjudicated indications. Thus, the details in the medical records are necessary for accurate indication classification.
Long-term results of the fludarabine, cyclophosphamide, and rituximab regimen as initial therapy of chronic lymphocytic leukemia.

Early results of the fludarabine, cyclophosphamide, and rituximab (FCR) regimen in 224 patients showed that it was highly active as initial therapy of chronic lymphocytic leukemia. In this report, we present the final results of all 300 study patients at a median follow up of 6 years. The overall response rate was 95%, with complete remission in 72%, nodular partial remission in 10%, partial remission due to cytopenia in 7%, and partial remission due to residual disease in 6%. Two patients (< 1%) died within 3 months of starting therapy. Six-year overall and failure-free survival were 77% and 51%, respectively. Median time to progression was 80 months. Pretreatment characteristics independently associated with inferior response were age 70 years or older, beta2-microglobulin twice the upper limit of normal (2N) or more, white cell count 150 x 10(9)/L or more, abnormal chromosome 17, and lactate dehydrogenase 2N or more. No pretreatment characteristic was independently associated with decreased complete remission duration. The risk of late infection was 10% and 4% for the first and second years of remission, respectively, and less than 1.5% per year for the third year onward. In a multivariate analysis of patients receiving fludarabine-based therapy at our center, FCR therapy emerged as the strongest independent determinant of survival.
Early Changes of Mannose-Binding Lectin, H-Ficolin, and Procalcitonin in Patients with Febrile Neutropenia: A Prospective Observational Study

The significance of mannose-binding lectin (MBL) and H-ficolin deficiency in febrile neutropenic (FN) patients and the correlation of these markers along with consecutive C-reactive protein (CRP) and procalcitonin (PCT) levels during the infectious process are investigated.



Patients with any hematological malignancies who were defined to have "microbiologically confirmed infection", "clinically documented infection", or "fever of unknown origin" were included in this single-center prospective observational study. Serum levels of CRP, PCT, MBL, and H-ficolin were determined on 3 separate occasions: at baseline (between hospital admission and chemotherapy), at the onset of fever, and at the 72nd hour of fever.



Forty-six patients (54% male, mean age 41.7 years) with 61 separate episodes of FN were evaluated. Eleven patients (23.9%) had "microbiologically confirmed infection", 17 (37%) had "clinically documented infection", and 18 (39.1%) had "fever of unknown origin". Fourteen (30.4%) patients had low (<500 ng/mL) initial MBL levels and 7 (15.21%) had low (<12,000 ng/mL) H-ficolin levels. Baseline MBL and H-ficolin levels did not significantly change on the first and third days of fever (p=0.076). Gram-negative bacteremia more frequently occurred in those with low initial MBL levels (p=0.006). PCT levels were significantly higher in those with microbiologically documented infections. Mean and median PCT levels were significantly higher in cases with bacteremia. There was no significant difference between hemoculture-positive and-negative patients in terms of CRP levels.



Monitoring serum H-ficolin levels was shown to be of no benefit in terms of predicting severe infection. Low baseline MBL levels were correlated with high risk of gram-negative bacteremia; however, no significant correlation was shown in the follow-up. Close monitoring of PCT levels is warranted to provide more accurate and specific data while monitoring cases of bacteremia.
Successful coordination and execution of nontherapeutic studies in a cooperative group setting: lessons learned from Children's Oncology Group studies.

The immense progress made in childhood cancer survival has been due to the systematic and efficient conduct of large multicenter therapeutic trials, using the infrastructure developed by national cooperative groups. These therapeutic trials have been successful, in part due to the high participation rates by the participating member institutions. However, participation in nontherapeutic trials in the cooperative group setting has lagged behind that of therapeutic trials for a variety of reasons, such as lack of institutional resources, leading to low priority given to such activities. The purpose of this report is to share some of the methods developed and successfully implemented by a coordinating center (City of Hope National Medical Center) to maximize institutional participation and patient enrollment and to standardize data collection and quality control, in order to ensure the successful execution of two large, extramurally funded, cooperative group nontherapeutic studies. To date, over 175 institutions have obtained regulatory approval for the protocols showcased here, accrual has been on target, and completeness and quality of the collected data have been excellent. The successful execution of these nontherapeutic studies shows the advantages of diverse study publicity techniques, detailed standardized operating procedures, and effective utilization of technological resources.
Role of pill-taking, expectation and therapeutic alliance in the placebo response in clinical trials for major depression.

Pill-taking, expectations and therapeutic alliance may account for much of the benefit of medication and placebo treatment for major depressive disorder (MDD).  To examine the effects of medication, placebo and supportive care on treatment outcome, and the relationships of expectations and therapeutic alliance to improvement.



A total of 88 participants were randomised to 8 weeks of treatment with supportive care alone or combined with double-blind treatment with placebo or antidepressant medication. Expectations of medication effectiveness, general treatment effectiveness and therapeutic alliance were measured (trial registration at ClinicalTrials.gov: NCT00200902).



Medication or placebo plus supportive care were not significantly different but had significantly better outcome than supportive care alone. Therapeutic alliance predicted response to medication and placebo; expectations of medication effectiveness at enrolment predicted only placebo response.



Pill treatment yielded better outcome than supportive care alone. Medication expectations uniquely predicted placebo treatment outcome and were formed by time of enrolment, suggesting that they were shaped by prior experiences outside the clinical trial.