Research Costs Investigated: A Study Into the Budgets of Dutch Publicly Funded Drug-Related Research

Background: The costs of performing research are an important input in value of information (VOI) analyses but are difficult to assess. Objective: The aim of this study was to investigate the costs of research, serving two purposes: (1) estimating research costs for use in VOI analyses; and (2) developing a costing tool to support reviewers of grant proposals in assessing whether the proposed budget is realistic. Methods: For granted study proposals from the Netherlands Organization for Health Research and Development (ZonMw), type of study, potential cost drivers, proposed budget, and general characteristics were extracted. Regression analysis was conducted in an attempt to generate a ‘predicted budget’ for certain combinations of cost drivers, for implementation in the costing tool. Results: Of 133 drug-related research grant proposals, 74 were included for complete data extraction. Because an association between cost drivers and budgets was not confirmed, we could not generate a predicted budget based on regression analysis, but only historic reference budgets given certain study characteristics. The costing tool was designed accordingly, i.e. with given selection criteria the tool returns the range of budgets in comparable studies. This range can be used in VOI analysis to estimate whether the expected net benefit of sampling will be positive to decide upon the net value of future research. Conclusion: The absence of association between study characteristics and budgets may indicate inconsistencies in the budgeting or granting process. Nonetheless, the tool generates useful information on historical budgets, and the option to formally relate VOI to budgets. To our knowledge, this is the first attempt at creating such a tool, which can be complemented with new studies being granted, enlarging the underlying database and keeping estimates up to date

Study protocol for a randomised controlled multicentre study:the Foraminotomy ACDF Cost-Effectiveness Trial (FACET) in patients with cervical radiculopathy

INTRODUCTION: Cervical radiculopathy due to discogenic or spondylotic stenosis of the neuroforamen can be surgically treated by an anterior discectomy with fusion (ACDF) or a posterior foraminotomy (FOR). Most surgeons prefer ACDF, although there are indications that FOR is as effective as ACDF, has a lower complication rate and is less expensive. A head-to-head comparison of the 2 surgical techniques in a randomised controlled trial has not yet been performed. The study objectives of the Foraminotomy ACDF Cost-Effectiveness Trial (FACET) study are to compare clinical outcomes, complication rates and cost-effectiveness of FOR to ACDF. METHODS AND ANALYSIS: The FACET study is a prospective randomised controlled trial conducted in 7 medical centres in the Netherlands. The follow-up period is 2 years. The main inclusion criterion is a radiculopathy of the C4, C5, C6 or C7 nerve root, due to a single-level isolated cervical foraminal stenosis caused by a soft disc and/or osteophytic component, requiring operative decompression. A sample size of 308 patients is required to test the hypothesis of clinical non-inferiority of FOR versus ACDF. Primary outcomes are: 'operative success', the measured decrease in radiculopathy assessed by the visual analogue scale and 'patient success', assessed by the modified Odom's criteria. Secondary outcomes are: Work Ability Index (single-item WAI), quality of life (EuroQol 5 Dimensions 5 level Survey, EQ-5D-5L), Neck Disability Index (NDI) and complications. An economic evaluation will assess cost-effectiveness. In addition, a budget impact analysis will be performed. ETHICS AND DISSEMINATION: Ethical approval was obtained from the Institutional Ethics Committee of the University Medical Center Groningen. Results of this study will be disseminated through national and international papers. The participants and relevant patient support groups will be informed about the results of the study. TRIAL REGISTRATION NUMBER: NTR5536, pre-results

What keeps nurses from the sexual counseling of patients with heart failure?

OBJECTIVES: We sought to examine the current practice of discussing sexual health by heart failure (HF) nurses, and to explore which barriers prevent nurses from discussing sexuality. METHODS: The Nurses' Survey of Sexual Counseling of Myocardial Infarction Patients and a list of barriers were used to form a questionnaire, which was sent to all HF clinics (n = 122) in the Netherlands. RESULTS: The majority (75%) of nurses (n = 146) felt a certain responsibility to discuss patients' sexual health. However, in practice, 61% of the nurses rarely or never addressed sexuality. Barriers that prevented nurses from addressing sexuality and that differed between nurses who do (n = 58) and do not (n = 88) discuss sexuality include a lack of organizational policy (49% vs. 79%, respectively; P < .001) and lack of training (43% vs. 80%, respectively; P < .001), and not knowing how to initiate the subject (24% vs. 72%, respectively; P < .001). Nurses preferred to address sexuality during a follow-up visit or when discussing medication. CONCLUSIONS: Although HF nurses feel responsible for discussing sexuality, this topic is rarely addressed in clinics. Several barriers were identified, relating to personal, patient, and organizational factors

Quality of life is impaired similarly in heart failure patients with preserved and reduced ejection fraction

Aims To compare quality of life (QoL) in heart failure (HF) patients with preserved ejection fraction (HF-PEF) and HF patients with reduced ejection fraction (HF-REF) in a well-defined HF population. Methods and results Patients with HF-PEF [left ventricular ejection fraction (LVEF) >= 40%] were matched by age and gender to patients with HF-REF (LVEF,40%). In the current study, we only included HF patients with a B-type natriuretic peptide level (BNP) > 100 pg/mL. Quality of life was assessed by Cantril's Ladder of Life, RAND-36, and the Minnesota Living with Heart Failure questionnaire, and impairment of QoL was adjusted for by BNP as a marker for severity of HF. We examined a total of 290 HF patients, of whom 145 had HF-PEF (41% female; age 72 +/- 10; LVEF 51 +/- 8%) and 145 had HF-REF (41% female; age 73 +/- 10, LVEF 26 +/- 7%). All HF patients reported markedly low scores of QoL, both on the general and disease-specific QoL questionnaires. Quality of life between patients with HF-PEF and HF-REF did not differ significantly. When adjusting the QoL scores for BNP, an association between QoL and LVEF was not found, i.e. patients with HF-PEF and HF-REF with similar BNP levels had the same impairment in QoL. Conclusion Quality of life is similarly impaired in patients with HF-PEF as in HF-REF. These findings further support the need for more pharmacological and non-pharmacological studies in patients with HF-PEF

Depressive symptoms are prominent among elderly hospitalised heart failure patients

Background: There are limited data on the prevalence of depressive symptoms in hospitalised elderly HF patients and demographic and clinical characteristics associated with depressive symptoms are not known. Methods: A sample of 572 HF patients (61% male; age 71 +/- 12 years; LVEF 34%+/- 15) was recruited from 17 Dutch hospitals during HF admission. Depressive symptoms were assessed by the CES-D. Demographic, clinical variables and HF symptoms were collected from patient chart and interview. Results: Forty one percent of the patients had symptoms of depression with women significantly more often reporting depressive symptoms than men 48% vs. 36% (chi(2)=8.1, p < 0.005). HF patients with depressive symptoms reported more clinical HF symptoms than patients without depressive symptoms. Even after deleting HF related symptoms (sleep disturbances and loss of appetite) from the CES-D scale, 36% of patients were still found to have symptoms of depression. Multivariable logistic regression analyses revealed that depressive symptoms were associated with female gender (odds 1.68, 95% CI 1.14-2.48), COPD (odds 2.11, 95% CI 1.35-3.30), sleep disturbance (odds 3.45, 95% CI 2.03-5.85) and loss of appetite (odds 2.61, 95% CI 1.58-4.33). Conclusions: Depressive symptoms are prominent in elderly hospitalised HF patients especially in women. Depressive symptoms are associated with more pronounced symptomatology, despite the fact that other indices of severity of left ventricular dysfunction are similar. 0 2005 European Society of Cardiology. Published by Elsevier B.V. All rights reserved

Perceived sexual difficulties and associated factors in patients with heart failure

Background Sexual dysfunction is a common problem of increasing incidence in patients with heart failure (HF). However, there is no knowledge on which demographic, clinical, and quality of life (QoL) aspects are related to difficulties in sexual activity nor on the course of sexual difficulties in patients with HF. less thanbrgreater than less thanbrgreater thanMethods Data on sexual difficulties were collected at 1 and 18 months after an HF hospitalization (n = 792, mean age 69 +/- 12 years, 35% female, mean left ventricular ejection fraction 33% +/- 14%) by the question on sexuality of the Minnesota living with HF questionnaire. Demographic and clinical factors were assessed from medical records and QoL by Minnesota living with HF questionnaire, Medical Outcome Study 36-item General Health Survey, and Ladder of Life. less thanbrgreater than less thanbrgreater thanResults In total, 48% (n = 380) of the patients perceive difficulties in sexual activity at 1 month after discharge, and 70% continued to perceive this at 18 months. Furthermore, 27% of the patients without difficulties at 1 month developed them during follow-up. Living with a partner (OR 3.76, 95% CI 2.58-5.48), younger age (OR 0.96, 95% CI 0.94-0.97)), male gender (OR 3.08, 95% CI 2.10-4.43), overall well-being (OR 1.13, 95% CI 1.00-1.27), and physical (OR 1.06, 95% CI 1.06-1.08) and emotional (OR 1.07, 95% CI 1.03-1.10) QoL were independently associated with perceived difficulties in sexual activity. less thanbrgreater than less thanbrgreater thanConclusions Perceived difficulties in sexual activity are common in patients with HF, particularly in younger and male patients and continue over time. Patients who perceive difficulties in sexual activity report a significant lower QoL and overall well-being than those who do not.Funding Agencies|Netherlands Heart Foundation|2000Z003D97.017|Biosite Europe, France||Roche Diagnostics, The Netherlands||Novartis Pharma BV, The Netherlands|