Cost-effectiveness Recommendations Research Articles

Assessing the impact of grief on quality of life, work productivity, and health outcomes for parents bereaved from SMA: A study protocol

BackgroundU.S. cost-effectiveness recommendations suggest that analyses should include all costs and effects relevant to the decision problem [1]. However, in many diseases, including spinal muscular atrophy (SMA), few studies have evaluated bereaved family outcomes after a child has died, neglecting potential impacts on their health-related quality of life (HRQoL), work productivity, and mental health. Additionally, grief-related outcomes are rarely included in economic evaluations. This manuscript outlines the protocol of a study that will estimate the HRQoL, work functioning, and mental health of bereaved parents of children with SMA type 1 to determine how outcomes vary based on parent’s sex and the time since a child’s death.MethodsThis study will involve two phases. In Phase 1, we will conduct a literature review to identify prior research that has measured how parental grief impacts HRQoL, work productivity, and mental health. We will also interview four bereaved parents of children with SMA type 1, stratified by parent sex and time since their child’s death, and analyze findings using a thematic analysis. In Phase 2, we will develop a survey draft based on Phase 1 findings. Parents bereaved from SMA type 1 will review our survey draft and we will revise the survey based on their feedback. We will send a cross-sectional survey to approximately 880 parents bereaved from SMA type 1. We will analyze findings from the survey to investigate whether the severity of grief symptoms is correlated with HRQoL, productivity, depression and anxiety symptom severity. We will also evaluate whether the mean scores of grief and each of the outcomes vary significantly when stratified by parent sex and the time since the child’s death.DiscussionOur results will provide preliminary information on how parental grief can impact HRQoL, productivity, and mental health outcomes over time. Increasing the availability of family outcomes data will potentially assist organizations performing health economic evaluations, such as the Institute of Clinical and Economic Review (ICER) in the U.S. This research will also help to inform the development of future economic guidelines on this topic.

The economic case for hospital discharge services for people experiencing homelessness in England: An in-depth analysis with different service configurations providing specialist care.

There are long-standing concerns that people experiencing homelessness may not recover well if left unsupported after a hospital stay. This study reports on a study investigating the cost-effectiveness of three different 'in patient care coordination and discharge planning' configurations for adults experiencing homelessness who are discharged from hospitals in England. The first configuration provided a clinical and housing in-reach service during acute care and discharge coordination but with no 'step-down' care. The second configuration provided clinical and housing in-reach, discharge coordination and 'step-down' intermediate care. The third configuration consisted of housing support workers providing in-reach and discharge coordination as well as step-down care. These three configurations were each compared with 'standard care' (control, defined as one visit by the homelessness health nurse before discharge during which patients received an information leaflet on local services). Multiple sources of data and multi-outcome measures were adopted to assess the cost utility of hospital discharge service delivery for the NHS and broader public perspective. Details of 354 participants were collated on service delivery costs (salary, on-costs, capital, overheads and 'hotel' costs, advertising and other indirect costs), the economic consequences for different public services (e.g. NHS, social care, criminal justice, housing, etc.) and health utilities (quality-adjusted-life-years, QALYs). Findings were complex across the configurations, but, on the whole, there was promising evidence suggesting that, with delivery costs similar to those reported for bed-based intermediate care, step-down care secured better health outcomes and improved cost-effectiveness (compared with usual care) within NICE cost-effectiveness recommendations.

Efficacy of “Worm-X” Herbal Formulation against Naturally Infected Gastrointestinal Nematodes in Goats of Banaskantha District, Gujarat

Background: Gastrointestinal nematodosis is a major constraint in economic livestock production. Mostly synthetic anthelmintics are being used to overcome this problem. Besides synthetic anthelmintics, some plants have shown variable anthelmintic properties. Methods: Sixty goats infected with GI nematodes having 1500 EPG were selected and animals were divided into four groups T1 to T4 of 15 animals in each group. Group T1 was given two doses of fenbendazole @ 10 mg/kg BW per os at 15 days interval. In group T2, T3 and T4 herbal formulation “Worm-X” was given @ 0.5, 1.0 and 2.0 ml/kg BW orally respectively, at 15 days interval. Efficacy was assessed on the basis of percentage reduction in EPG count and the FECRT was conducted as per guidelines of WAAVP. Result: When FECR was compared 15 days post treatment, maximum reduction (77.25%) was observed in group T1 followed by group T2 (47.27%), T3 (70.19%), and T4 (72.01%). The reduction in FEC in groupT3 (70.19%) and T4 (72.01%) at 15 days post treatment and at 30 days post treatment were 87.75 and 89.32%, respectively were almost equal. Considering the cost effectiveness and WAAVP recommendations, it will be optimum to administer the drug at the rate of 1.0 ml/kg body weight in two dosages at 15-day interval. However, it is well known that now a day’s modern anthelmintic drug efficacy has been reduced in many cases due to the development of anthelmintic resistance. Therefore, complementary or alternative solutions to the conventional chemical treatments have been implied offering novel approaches to the sustainable control of gastrointestinal nematodes in goats.

Understanding and Identifying Key Issues with the Involvement of Clinicians in the Development of Decision-Analytic Model Structures: A Qualitative Study.

Decision-analytic models play an essential role in informing healthcare resource allocation decisions; however, their value to decision makers will depend on model structures being clinically valid to determine cost-effectiveness recommendations. Clinician involvement can help modellers to develop clinically valid but straightforward structures; however, there is little guidance available on methods for clinician input to model structure. This study aims to provide an in-depth exploration of clinician involvement in structural development, highlighting key issues and generating recommendations to optimise practices. A qualitative study was undertaken with a range of modellers and clinicians working in different modelling contexts. In-depth interviews and case studies using observations were carried out to understand how clinicians are involved in model structural development and to identify problems and optimal approaches from informants' perspectives. Twenty-four interviews and two case studies were undertaken with modellers and modelling teams. Key issues included the number and diversity of clinicians contributing to structural development, potentially impacting the generalisability of structures, and problems with clinician understanding of important information to contribute to model pathways. Modellers and clinicians suggested that clinician training in modelling could enhance structural processes. Recommendations to optimise current practices include recruiting clinicians from a variety of backgrounds and using discussions between experts to develop valid and generalisable structures. Future research should focus on developing training materials for clinicians and finding ways to help modellers recruit clinicians from different settings.

Cost-effectiveness of prostate cancer screening: a systematic review of decision-analytical models

BackgroundThere is ongoing debate about the harms and benefits of a national prostate cancer screening programme. Several model-based cost-effectiveness analyses have been developed to determine whether the benefits of prostate cancer screening outweigh the costs and harms caused by over-detection and over-treatment, and the different approaches may impact results.MethodsTo identify models of prostate cancer used to assess the cost-effectiveness of prostate cancer screening strategies, a systematic review of articles published since 2006 was conducted using the NHS Economic Evaluation Database, Medline, EMBASE and HTA databases. The NICE website, UK National Screening website, reference lists from relevant studies were also searched and experts contacted. Key model features, inputs, and cost-effectiveness recommendations were extracted.ResultsTen studies were included. Four of the studies identified some screening strategies to be potentially cost-effective at a PSA threshold of 3.0 ng/ml, including single screen at 55 years, annual or two yearly screens starting at 55 years old, and delayed radical treatment. Prostate cancer screening was modelled using both individual and cohort level models. Model pathways to reflect cancer progression varied widely, Gleason grade was not always considered and clinical verification was rarely outlined. Where quality of life was considered, the methods used did not follow recommended practice and key issues of overdiagnosis and overtreatment were not addressed by all studies.ConclusionThe cost-effectiveness of prostate cancer screening is unclear. There was no consensus on the optimal model type or approach to model prostate cancer progression. Due to limited data availability, individual patient-level modelling is unlikely to increase the accuracy of cost-effectiveness results compared with cohort-level modelling, but is more suitable when assessing adaptive screening strategies. Modelling prostate cancer is challenging and the justification for the data used and the approach to modelling natural disease progression was lacking. Country-specific data are required and recommended methods used to incorporate quality of life. Influence of data inputs on cost-effectiveness results need to be comprehensively assessed and the model structure and assumptions verified by clinical experts.

Measuring Care-Related Quality of Life of Caregivers for Use in Economic Evaluations: CarerQol Tariffs for Australia, Germany, Sweden, UK, and US.

BackgroundInformal care is often not included in economic evaluations in healthcare, while the impact of caregiving can be relevant for cost-effectiveness recommendations from a societal perspective. The impact of informal care can be measured and valued with the CarerQol instrument, which measures the impact of informal care on seven important burden dimensions (CarerQol-7D) and values this in terms of general quality of life (CarerQol-VAS). The CarerQol can be included at the effect side of multi-criteria analyses of patient interventions or in cost-effectiveness or utility analysis of interventions targeted at caregivers.ObjectiveAt present, utility scores based on relative utility weights for the CarerQol-7D are only available for the Netherlands. This study calculates CarerQol-7D tariffs for Australia, Germany, Sweden, UK, and US.MethodsData were collected among the general population in Australia, Germany, Sweden, UK, and US by an Internet survey. Utility weights were collected with a discrete choice experiment with two unlabeled alternatives described in terms of the seven CarerQol-7D dimensions. An efficient experimental design with priors obtained from the Netherlands was used to create the choice sets. Data was analyzed with a panel mixed multinomial logit model with random parameters.ResultsIn all five countries, the CarerQol-7D dimensions were significantly associated with the utility of informal care situations. Physical health problems were most strongly associated with the utility for informal care situations. The tariff was constructed by adding up the relative utility weights per category of all CarerQol-7D dimensions for each country separately.ConclusionThe CarerQol tariffs for Australia, Germany, Sweden, UK, and US facilitate the inclusion of informal care in economic evaluations.

Departures from Cost-Effectiveness Recommendations: The Impact of Health System Constraints on Priority Setting

—The methods and application of cost-effectiveness analysis have reached an advanced stage of development. Many decision makers consider cost-effectiveness analysis (CEA) to be a valid and feasible approach toward setting health priorities, and it has been extensively applied in evaluating interventions and developing evidence-based clinical guidelines. However, the recommendations arising from cost-effectiveness analysis are often not implemented as intended. A fundamental reason for the failure to implement is that CEA assumes a single constraint, in the form of the budget constraint, whereas in reality decision makers may be faced with numerous other constraints. The objective of this article is to develop a typology of constraints that may act as barriers to implementation of cost-effectiveness recommendations. Six categories of constraints are considered: the design of the health system; costs of implementing change; system interactions between interventions; uncertainty in estimates of costs and benefits; weak governance; and political constraints. Where possible—and if applicable—for each class of constraint, the article discusses ways in which these constraints can be taken into account by a decision maker wishing to pursue the principles of cost-effectiveness.

The influence of waiting times on cost-effectiveness: a case study of colorectal cancer mass screening

When a cost-effectiveness analysis is implemented, the health-care system is usually assumed to adjust smoothly to the proposed new strategy. However, technological innovations in health care may often induce friction in the organization of care supply, implying the congestion of services and subsequent waiting times. Our objective here is to measure how these short run rigidities can challenge cost-effectiveness recommendations favorable to an innovative mass screening test for colorectal cancer. Using Markov modeling, we compare the standard Guaiac fecal occult blood test (gFOBT) with an innovative screening test for colorectal cancer, namely the immunological fecal occult blood test (iFOBT). Waiting time can occur between a positive screening test and the subsequent confirmation colonoscopy. Five scenarios are considered for iFOBT: no further waiting time compared with gFOBT, twice as much waiting time for a period of 5 or 10 years, and twice as much waiting time for a period of 5 or 10 years combined with a 25% decrease in participation to confirmation colonoscopies. According to our modeling, compared with gFOBT, iFOBT would approximately double colonoscopy demand. Probabilistic sensitivity analysis enables concluding that the waiting time significantly increases the uncertainty surrounding recommendations favorable to iFOBT if it induces a decrease in the adherence rate for confirmation colonoscopy.

Foot Care

Foot Care

Post-operative nausea and vomiting prevention with perphenazine: long overdue

Editor, With great interest, we read Schnabel et al.1 who presented a quantitative systematic review addressing perphenazine and the prevention of post-operative nausea and vomiting (PONV). Our group began using intravenous perphenazine in 1997; we were forced to switch to oral perphenazine in 2002, as an injectable form was no longer available in the United States. We would like to complement their report with relevant citations that may be valuable, despite our outcomes having occurred outside of typical reports involving randomised trials.2 When we first reported (after knee surgery) routine bypass of the post-anaesthesia care unit (PACU bypass) in 2000,3 and in follow-up knee surgery studies,4–6 perphenazine (2 mg intravenously) and dexamethasone (4 mg intravenously) were the recommended anti-emetics in our clinical pathway. In a separate analysis of n = 449 shoulder surgery out-patients from our institution (94% of whom bypassed PACU), perphenazine–dexamethasone prophylaxis (versus 1 or fewer anti-emetics) was associated with a 50% reduction in the need for in-hospital PONV rescue and faster discharge time to home.7 In our experiences with oral perphenazine (8 mg before surgery), combined with intravenous ondansetron (4 mg) and intravenous dexamethasone (4 mg) during surgery, we reported a 4% PONV incidence after out-patient anterior cruciate ligament construction (n = 233) under spinal anaesthesia.8 In a separate retrospective population study at our institution, orthopaedic patients received the same doses of dexamethasone–ondansetron with (n = 6605) or without (n = 2853) pre-operative oral perphenazine (8 mg). The need for ondansetron rescue in patients not receiving perphenazine was 18%, but only 13% in patients who received perphenazine.9 This 27% reduction matches the classical study by Apfel et al.10 with respect to the anticipated 25% risk reduction achieved with droperidol administration; we are not aware of perphenazine being non-efficacious in men as Apfel et al.10 reported droperidol to be. When perphenazine doses were not repeated, we never encountered an adverse event to our knowledge. This was true, specifically when the intravenous dose was less than or equal to 2 mg, or when the single pre-operative oral dose did not exceed 8 mg. Our criteria for dosing 8 mg orally before surgery includes ages 14–70, patient weight no less than 45 kg, no history of extra-pyramidal reactions to medications (e.g. prochlorperazine), no history of Parkinson's disease, no history of cerebral palsy and no class III anti-dysrhythmic being co-administered for co-existing disease. For patients less than 14 years old, and/or less than 45 kg, we commonly use a 4 mg oral dose (assuming the patient is old enough to swallow pills without chewing). Any low-rate occurrences of extra-pyramidal symptoms after perphenazine dosing (i.e. outside of these guidelines) were immediately treated with diphenhydramine. Our hospital pharmacy archives did not indicate that any of our patients were prescribed benztropin treatment for extra-pyramidal symptoms after any perphenazine dosing for PONV prophylaxis on the day of surgery.9 Finally, owing to the non-sedating characteristics of single-dose perphenazine (when compared with such agents as droperidol, dimenhydrinate, promethazine, prochlorperazine and trans-dermal scopolamine), it should be acknowledged that PACU bypass has not been a traditional end point in most anti-emetic outcome studies, especially those involving multi-modal anti-emetic prophylaxis. Incorporating PACU bypass as a hospital-centred cost–benefit outcome forces all previous PONV-related recommendations to be re-evaluated. The 2007 Society for Ambulatory Anesthesia Consensus Guidelines for PONV11 do not acknowledge PACU bypass as an end point, and calibrated its cost-effectiveness recommendations based on the acquisition costs of still patent-protected ondansetron. In fact, the accompanying editorial by Glass and White12 plainly declared ‘given the high efficacy, low cost, and excellent safety profiles of the most commonly used anti-emetic drugs (e.g., droperidol, dexamethasone, and ondansetron), in our view these drugs should be routinely administered for anti-emetic prophylaxis of all patients receiving general anaesthesia irrespective of their risk classification.’ Following the logic of Glass and White, our reported clinical experience, and now the quantitative systematic review of Schnabel et al.,1 there is little justification not to routinely administer perphenazine, dexamethasone and ondansetron to all patients receiving anaesthesia irrespective of baseline PONV risk (given the aforementioned cautions/exceptions). All future studies of PONV should be required to consider PACU bypass as a secondary outcome in cost-effectiveness analysis, owing to the renaissance of a non-sedating anti-dopaminergic anti-emetic, that being perphenazine.

Transportability of Comparative Effectiveness and Cost-Effectiveness between Countries

the results for registration in more than one country. At the same time, this design poses a number of challenges for interpreting the resulting cost-effectiveness ratio(s). One of these challenges is whether the data required for cost-effectiveness analysis—and thus the cost-effectiveness recommendations—can be assumed to be equivalent across the different countries. In this article, a brief overview of the literature on economic analysis of multinational studies is presented. The first section relates to the background on the transferability of economic data and the second section discusses the results of a consensus conference on economic analysis of multinational trials. The third section considers the two main statistical approaches that have been advocated for handling the analysis of multinational data—fixed effect and random effect modeling methods—plus a third approach that has only recently been employed in the literature based on modeling the components of the costeffectiveness calculus. This approach is then illustrated using the results of the recently published cost-effectiveness analysis of the TOwards a Revolution in COPD Health (TORCH) trial [1]. A final section offers some conclusions for the use of such methods in comparative effectiveness and cost-effectiveness studies.

Reducing MRSA Infections in College Student Athletes: Implementation of a Prevention Program

An interventional prevention program, Training CAMP Program, was implemented with college football players (n = 98) in a Midwestern NCAA Division II college during the 2008 college football season. The program goal was a 50% reduction in community-acquired Methicillin-resistant Staphylococcus aureus (CA-MRSA) cases, as compared to the previous 3 seasons' average number of cases (12.6). Results showed a greater than 75% reduction in CA-MRSA in the target population, with only 3 cases recorded for the entire 2008 college football season. A 1-group pretest-posttest design paired t-test revealed increased knowledge and knowledge retention. Program description, implementation, evaluation, cost-effectiveness, and future recommendations are described.

Pneumococcal polysaccharide vaccine: cost–effectiveness recommendations in adults

Pneumococcal vaccination is an effective intervention to prevent pneumococcal infections. Earlier randomized clinical trials and most case-control studies have shown a significant protection against invasive pneumococcal diseases and pneumococcal pneumonia in the elderly and chronic patients with a higher risk of pneumococcal infections. However, more recent randomized clinical trials have only detected a significant protection in immunocompetent individuals. A review of the studies assessing the cost–effectiveness of the 23-valent polysaccharide vaccine has shown that pneumococcal vaccination should be recommended in all individuals aged over 64 years, and in chronic patients with a higher risk of pneumocccal infections. In these population groups, vaccination costs are lower than healthcare costs reduced with the intervention. In individuals aged over 64 years, cost savings could be obtained when the vaccine effectiveness is higher than 30%. Recent cost–effectiveness studies have shown that pneumococcal vaccination could also be recommended in individuals aged between 45 and 64 years without risk factors, since the cost–effectiveness ratio is lower than €30,000 per life-year gained. In individuals aged between 45 and 64 years, cost savings could be obtained when the vaccine effectiveness is higher than 90%, and when the percentage of pneumonias caused by Streptococcus pneumoniae are 40%.