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- Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS
2022) Statement: Updated Reporting Guidance for Health Economic
Evaluations-
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Abstract: Abstract Health economic evaluations are comparative analyses of alternative courses of action in terms of their costs and consequences. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement, published in 2013, was created to ensure health economic evaluations are identifiable, interpretable, and useful for decision making. It was intended as guidance to help authors report accurately which health interventions were being compared and in what context, how the evaluation was undertaken, what the findings were, and other details that may aid readers and reviewers in interpretation and use of the study. The new CHEERS 2022 statement replaces previous CHEERS reporting guidance. It reflects the need for guidance that can be more easily applied to all types of health economic evaluation, new methods and developments in the field, and the increased role of stakeholder involvement, including patients and the public. It is also broadly applicable to any form of intervention intended to improve the health of individuals or the population, whether simple or complex, and without regard to context (such as healthcare, public health, education, social care, etc.). This summary article presents the new CHEERS 2022 28-item checklist and recommendations for each item. The CHEERS 2022 statement is primarily intended for researchers reporting economic evaluations for peer-reviewed journals as well as the peer reviewers and editors assessing them for publication. However, we anticipate familiarity with reporting requirements will be useful for analysts when planning studies. It may also be useful for health technology assessment bodies seeking guidance on reporting, as there is an increasing emphasis on transparency in decision making.
PubDate: 2022-06-01
- Target Trial Emulation for Transparent and Robust Estimation of Treatment
Effects for Health Technology Assessment Using Real-World Data:
Opportunities and Challenges-
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Abstract: Abstract Evidence about the relative effects of new treatments is typically collected in randomised controlled trials (RCTs). In many instances, evidence from RCTs falls short of the needs of health technology assessment (HTA). For example, RCTs may not be able to capture longer-term treatment effects, or include all relevant comparators and outcomes required for HTA purposes. Information routinely collected about patients and the care they receive have been increasingly used to complement RCT evidence on treatment effects. However, such routine (or real-world) data are not collected for research purposes, so investigators have little control over the way patients are selected into the study or allocated to the different treatment groups, introducing biases for example due to selection or confounding. A promising approach to minimise common biases in non-randomised studies that use real-world data (RWD) is to apply design principles from RCTs. This approach, known as ‘target trial emulation’ (TTE), involves (1) developing the protocol with respect to core study design and analysis components of the hypothetical RCT that would answer the question of interest, and (2) applying this protocol to the RWD so that it mimics the data that would have been gathered for the RCT. By making the ‘target trial’ explicit, TTE helps avoid common design flaws and methodological pitfalls in the analysis of non-randomised studies, keeping each step transparent and accessible. It provides a coherent framework that embeds existing analytical methods to minimise confounding and helps identify potential limitations of RWD and the extent to which these affect the HTA decision. This paper provides a broad overview of TTE and discusses the opportunities and challenges of using this approach in HTA. We describe the basic principles of trial emulation, outline some areas where TTE using RWD can help complement RCT evidence in HTA, identify potential barriers to its adoption in the HTA setting and highlight some priorities for future work.
PubDate: 2022-06-01
- EQ-5D-Y Value Set for Germany
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Abstract: Background Demand is increasing for youth-specific preference-based health-related quality-of-life measures for inclusion in evaluations of healthcare interventions for children and adolescents. The EQ-5D-Youth (EQ-5D-Y) has the potential to become such a preference-based measure. Objective This study applied the recently published EQ-5D-Y valuation protocol to develop a German EQ-5D-Y value set and explored the differences between values given to youth health by parents and non-parents. Methods To elicit EQ-5D-Y health state preferences, a representative sample of 1030 adults of the general population completed a discrete choice experiment (DCE) online survey, and 215 adults participated in face-to-face interviews applying composite time trade-off (cTTO). Respondents were asked to consider a 10-year-old child living in the health states. DCE data were modelled using a mixed logit model. To derive the value set, DCE latent scale values were anchored onto adjusted mean cTTO values using a linear mapping approach. Results Adult respondents considered pain/discomfort and feeling worried/sad/unhappy as the two most important dimensions in terms of youth health. Adjusted mean cTTO values ranged from − 0.350 for health state 33333 to 0.970 for health state 21111. The EQ-5D-Y value set showed a logical order for all parameter estimates, and predicted values ranged from − 0.283 to 1. Differences in preferences by parental status were mainly observed for cTTO results, where mean values were larger for parents than for non-parents. Conclusions Applying the valuation protocol, a German EQ-5D-Y value set with internally consistent coefficients was developed. This enables the instrument to be used in economic evaluations of paediatric healthcare interventions.
PubDate: 2022-05-23
- Disease-Related Costs Published in The Middle East and North Africa
Region: Systematic Review and Analysis of Transferability-
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Abstract: Background In the Middle East and North Africa (MENA) the scarcity of local cost data is a key barrier to conducting health economic evaluations. We systematically reviewed reports of disease-related costs from MENA and analysed their transferability within the region. Methods We searched PubMed and included full text English papers that reported disease-related costs from the local populations of Algeria, Bahrain, Egypt, Iraq, Jordan, Saudi Arabia, Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Qatar, Syria, Tunisia, United Arab Emirates and Yemen between 1995 and 2019. Screening, study selection and data extraction were done in duplicate. Study-related variables, costing methods, all costs and their characteristics were extracted and analysed via descriptive methods. From multi-country studies of MENA employing homogenous costing methods, we estimated the ratio (cost transfer coefficient) between the relative differences in direct medical costs and macroeconomic indicators via robust regression. We predicted each cost via the estimated cost transfer formula and evaluated prediction error between true and predicted (transferred) costs. Results The search yielded 1646 records, 206 full text papers and 3525 costs from 84 diagnoses. Transferability was analysed involving 144 direct medical costs from eight multi-country studies. Adjusting the average of available foreign costs by 0.28 times the relative difference in GDP per capita provided the most accurate estimates. The correlation between true and predicted costs was 0.96; 68% of predicted costs fell in the true ± 50% range. Predictions were more accurate for costs from studies that involved the largest number of countries, for countries outside the Gulf region and for drug costs versus unit or disease costs. Conclusion The estimated cost transfer formula allows the prediction of missing costs in MENA if only GDP per capita is available for adjustment to the local setting. Input costs for the formula should be collected from multiple sources and match the decision situation.
PubDate: 2022-05-17
- Evaluating the Individual Healthcare Costs and Burden of Disease
Associated with RSV Across Age Groups-
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Abstract: Background Respiratory syncytial virus (RSV) is a major cause of acute respiratory infection (ARI), with high morbidity and mortality worldwide. RSV costing and burden estimates can highlight the potential benefits of future vaccination programs and are essential for economic evaluations. Objective We aimed to determine RSV healthcare costs across age groups and the overall disease burden of medically attended RSV in Canada. Methods We conducted a retrospective case–control study to estimate the attributable healthcare costs per RSV case in Alberta. We used two case definitions to capture diversity in case severity: laboratory-confirmed RSV and ARI attributable to RSV. Matching occurred on five criteria: (1) age, (2) urban/rural status, (3) sex, (4) prematurity and (5) Charlson Comorbidity Index score. We calculated the age-specific burden of medically attended RSV in Canada from 2010 to 2019 by multiplying the weekly age-specific incidence of medically attended ARI with the RSV positivity rate. Results Costs per laboratory-confirmed RSV case were (in Canadian dollars [CAD], year 2020 values) $CAD12,713 and 40,028 in the first 30 and 365 days following diagnosis, respectively, whereas a case of ARI potentially attributable to RSV cost $CAD316 and 915, in 30 and 365 days, respectively. Older (aged ≥ 65 years) and younger (aged < 90 days) age groups had the highest case costs. The average medically attended RSV incidence rate across nine seasons was 1743 cases per 100,000 people per year. Conclusions RSV is a common and expensive infection at the extremes of life, and the development of immunization programs targeting older and younger ages may be important for the reduction of RSV burden and cost.
PubDate: 2022-05-13
- Addressing Challenges to Alternative Payment Models for New Alzheimer’s
Disease Therapies for US Commercial Payers-
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Abstract: Abstract Commercial payers that ultimately decide to cover aducanumab or other Alzheimer’s disease therapies may require innovative payment tools to minimize their financial risk given the uncertain benefits and high cost of such treatments. Drawing on the published evidence, we propose two different types of payment models applicable to disease-modifying therapies in Alzheimer’s disease, and suggest four strategies to overcome challenges in their implementation. Such strategies range from developing best practices for outcome measurement in Alzheimer’s disease, investing in infrastructure to collect real-world data, increasing representativeness of registry data in Alzheimer’s disease, and integrating the diagnostic, treatment, and payment landscape. These important steps could make access to emerging therapies in Alzheimer’s disease more sustainable in the long term, and could serve as a blueprint for better access to novel therapies in other indications in the future.
PubDate: 2022-05-13
- Modeling the Ex Ante Clinical Real Option Value in an Innovative
Therapeutic Area: ALK-Positive Non-Small-Cell Lung Cancer-
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Abstract: Objectives A drug that improves survival and/or disease progression can create real option value (ROV)—the additional health gain from future innovations enabled by a longer survival. ROV can be a relevant consideration for both clinical and payer decision-makers. We aimed to estimate the ex ante ROV for first-line (1L) alectinib in anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC). Methods We developed a Markov model to estimate life-years (LYs) and quality-adjusted life-years (QALYs) gained with 1L alectinib versus 1L crizotinib due to potential future second-line (2L) drugs. Transition probabilities were derived from the phase 3 trial of 1L alectinib and phase 2 trial of 2L brigatinib. We identified drugs being studied in phase 2 and 3 trials in ALK-positive NSCLC at the time of alectinib’s 1L approval and projected the likelihood and timing of their arrival and their potential efficacy based on publicly available data. Results The discounted incremental LYs and QALYs for alectinib increased by 12.9% (95% CR − 2.96%, 34.82%; 1.25 vs. 1.11) and 11.2% (95% CR − 2.14%, 29.29%; 1.03 vs. 0.92), respectively, after accounting for ROV. The incremental ROV of alectinib was sensitive to the projected efficacy of future drugs, uptake level, and the hazard ratio of progression-free survival of alectinib (vs. crizotinib). Conclusions Ex ante ROV can be a significant value consideration in therapeutic areas with high levels of expected innovation. The potential efficacy of future drugs and incremental survival with alectinib at the projected time of arrival are important considerations in assessing ROV.
PubDate: 2022-05-09
- Exploring the Issues of Valuing Child and Adolescent Health States Using a
Mixed Sample of Adolescents and Adults-
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Abstract: Abstract Preferences for child and adolescent health states used to generate health state utility values can be elicited from adults, young adults, adolescents, or combinations of these. This commentary paper provides a critical overview of issues and implications arising from valuing child and adolescent health states using a novel approach of a mixed sample of adolescents and adults. The commentary is informed by critical analysis of normative, ethical, practical and theoretical arguments in the health state valuation literature. Discussion focusses upon adolescent empowerment, understanding and psychosocial maturity; ethical concerns; elicitation tasks; perspective; and selection of sample proportions across adolescents and adults. It is argued that valuation of child and adolescent health states by both adolescents and adults could involve all participants completing the same preference elicitation task using the same perspective (e.g. time trade-off imagining they are living in the health state), and all preferences being modelled to generate a combined value set that reflects both adolescent and adult preferences. It is concluded that the valuation of child and adolescent health states by a mixed adolescent and adult sample appears feasible and has the advantage that it includes some of the population who can potentially experience the health states, thus enabling adolescents to express their views around matters that may affect them, and the population that are taxpayers and voters. However, both the relative proportion of adults and adolescents to include in a valuation sample and the elicitation technique require careful consideration.
PubDate: 2022-05-01
- Cost‑Effectiveness Risk‑Aversion Curves: Comparison of Risk-Adjusted
Performance Measures and Expected-Utility Approaches-
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Abstract: Abstract Accounting for risk attitudes in medical decision making under uncertainty has attracted little research. A recent proposal recommended using the results of a cost-effectiveness analysis to construct a cost-effectiveness risk-aversion curve (CERAC) to inform risk-averse decision makers choosing among healthcare programs with uncertain costs and effects. The CERAC is based on a risk-adjusted performance measure widely used in financial economics called the Sortino ratio. This paper evaluates the CERAC based on the Sortino ratio, derives its various properties, discusses the implications of using it to inform decision making under uncertainty, and compares it with the expected-utility approach. Analytic formulae for the CERAC, relating it to the means and standard deviations of costs and effects of a healthcare program, are derived for both approaches. Compared with the expected-utility approach, the CERAC based on the Sortino ratio implicitly assumes that the decision maker is highly risk averse.
PubDate: 2022-05-01
- Mogamulizumab for Previously Treated Mycosis Fungoides and Sézary
Syndrome: An Evidence Review Group Perspective of a NICE Single Technology
Appraisal-
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Abstract: Abstract The National Institute for Health and Care Excellence (NICE) invited the manufacturer (Kyowa Kirin) of mogamulizumab (Poteligeo®), as part of the single technology appraisal process, to submit evidence for its clinical and cost-effectiveness for previously treated mycosis fungoides (MF) and Sézary syndrome (SS). Kleijnen Systematic Reviews Ltd, in collaboration with Maastricht University Medical Centre, was commissioned to act as the independent evidence review group (ERG). This paper summarises the company submission (CS), presents the ERG’s critical review of the clinical and cost-effectiveness evidence in the CS, highlights the key methodological considerations and describes the development of the NICE guidance by the Appraisal Committee. Based on a systematic literature review, one randomised controlled trial, MAVORIC, was identified showing favourable results in patients with MF and SS. However, MAVORIC compared mogamulizumab to vorinostat, which is not standard care in the NHS, and there is uncertainty due to the study design, specifically crossover of patients. Based on a “naïve comparison of results from the vorinostat arm of the MAVORIC study and the physician’s choice arm (methotrexate or bexarotene i.e. United Kingdom [UK] standard treatments) of the ALCANZA study as well as comparison to Phase II bexarotene data”, the company considered vorinostat to be “a reasonable proxy for current standard of care in the NHS”. The ERG considered, based on the limited data available, that the comparability of vorinostat (MAVORIC) and physician’s choice (ALCANZA) could not be established. In response to the Appraisal Consultation Document, the company provided an unanchored matched adjusted indirect comparison (MAIC) of mogamulizumab with UK standard care by analysing Hospital Episode Statistics (HES) data. However, given the high risk of bias of an unanchored MAIC, these results needed to be regarded with a considerable degree of caution. The economic analysis suffered from uncertainty because there was no trial evidence on the comparator in the England and Wales National Health Service (NHS), and it was unclear to what extent the trial (MAVORIC) comparator (vorinostat) was comparable to standard care, referred to as established clinical management (ECM) in the NHS. The evidence for overall survival had not reached maturity and was confounded by treatment switching, for which different crossover adjustment methods produced large variations in life years. Caregiver utilities were applied in the analysis, but there was a lack of guidance on their application and whether these were indicated in this appraisal. After consultation, the company updated the economic analysis with the MAIC. Incremental cost-effectiveness ratios comparing mogamulizumab against ECM were (depending on whether the HES or MAVORIC comparison were used) £31,030 or £32,634 per quality-adjusted life years (QALYs) gained according to the company’s base case and £38,274 or £80,555 per QALY gained according to the ERG’s base case. NICE did not recommend mogamulizumab for treating MF or SS in adults who have had at least one previous systemic treatment. This decision was subsequently appealed, and an appeal decision has been reached.
PubDate: 2022-05-01
- Assessments of the Value of New Interventions Should Include Health Equity
Impact-
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Abstract: Abstract A formal evaluation of the health equity impact of a new intervention is hardly ever performed as part of a health technology assessment to understand its value. This should change, in our view. An evidence-based quantitative assessment of the health equity impact can help decision makers develop coverage policies, programme designs, and quality initiatives focused on optimizing both total health and health equity given the treatment options available. We outline the conceptual basis of how a new intervention can impact health equity and adopt distributional cost-effectiveness analysis based on decision-analytic models to assess this quantitatively, using a newly US FDA-approved drug for Alzheimer’s disease (aducanumab) as an example. We argue that gaps in the evidence base for the new intervention, for example, due to limited clinical research participation among racial and ethnic minority groups, do not preclude such an evaluation. Understanding these uncertainties has implications for fair pricing, decision making, and future research. If we are serious about population-level decision making that not only is focused on improving total health but also aims to improve health equity, we should consider routinely assessing the health equity impact of new interventions.
PubDate: 2022-05-01
- Economic and Humanistic Burden of Triple-Negative Breast Cancer: A
Systematic Literature Review-
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Abstract: Background Triple-negative breast cancer (TNBC) accounts for 10–20% of all breast cancers (BCs). It is more commonly diagnosed in younger women and often has a less favorable prognosis compared with other BC subtypes. Objective The objective of this study was to provide a literature-based extensive overview of the economic and humanistic burden of TNBC to assist medical decisions for healthcare payers, providers, and patients. Methods A systematic literature review was performed using multiple databases, including EMBASE, MEDLINE, Econlit, the Cochrane Central Register of Controlled Trials, and the Cochrane Database of Systematic Reviews, from database inception to 16 May 2021. In addition, a targeted search was performed in the Northern Light Life Sciences Conference s database from 2016 through June 2021. The bibliographies of included articles were reviewed to identify other potentially relevant publications. Quality assessment of the included studies was conducted. Results The review identified 19 studies assessing the economic burden and 10 studies assessing the humanistic burden of TNBC. Studies varied widely in study design, settings, patient populations, and time horizons. The estimates of mean per-patient annual direct medical costs ranged from around $20,000 to over $100,000 in stage I–III TNBC and from $100,000 to $300,000 in stage IV TNBC. Healthcare costs and resource utilization increased significantly with disease recurrence, progression, and increased cancer stage or line of therapy. Compared with the costs of systemic anticancer therapy, cancer management costs comprised a larger portion of total direct costs. The estimates of indirect costs due to productivity loss ranged from $207 to $1573 per patient per month (all costs presented above were adjusted to 2021 US dollars). Cancer recurrence led to significantly reduced productivity and greater rates of leaving the workforce. A rapid deterioration of health utility associated with disease progression was observed in TNBC patients. Treatment with pembrolizumab or talazoparib showed significantly greater improvements in health-related quality of life (HRQoL) compared with chemotherapy, as measured by EORTC QLQ-C30, QLQ-BR23, and FACT-B. Conclusion TNBC is associated with a substantial economic burden on healthcare systems and societies and considerably reduced productivity and HRQoL for patients. This study synthesized the published literature on the economic and humanistic burden of TNBC and highlighted the need for continued research due to the rapidly changing landscape of TNBC care.
PubDate: 2022-05-01
- The Cost Effectiveness of Levodopa-Carbidopa Intestinal Gel in the
Treatment of Advanced Parkinson’s Disease in England-
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Abstract: Background Parkinson’s disease is a progressive neurodegenerative disease, which significantly impacts patients’ quality of life and is associated with high treatment and direct healthcare costs. In England, levodopa/carbidopa intestinal gel (LCIG) is indicated for the treatment of levodopa-responsive advanced Parkinson’s disease with troublesome motor fluctuations when available combinations of medicinal products are unsatisfactory. Objective We aimed to determine the cost effectiveness of LCIG compared to the standard of care for patients with advanced Parkinson’s disease in England, using real-world data. Methods A Markov model was adapted from previous published studies, using the perspective of the English National Health System and Personal and Social Services to evaluate the cost effectiveness of LCIG compared to standard of care in patients with advanced Parkinson’s disease over a 20-year time horizon. The model comprised 25 health states, defined by a combination of the Hoehn and Yahr scale, and waking time spent in OFF-time. The base case considered an initial cohort of patients with an Hoehn and Yahr score of ≥ 3, and > 4 h OFF-time. Standard of care comprised standard oral therapies, and a proportion of patients were assumed to be treated with subcutaneous apomorphine infusion or injection in addition to oral therapies. Efficacy inputs were based on LCIG clinical trials where possible. Resource use and utility values were based on results of a large-scale observational study, and costs were derived from the latest published UK data, valued at 2017 prices. The EuroQol five-dimensions-3-level (EQ-5D-3L) instrument was used to measure utilities. Costs and quality-adjusted life-years were discounted at 3.5%. Both deterministic and probabilistic sensitivity analyses were conducted. Results Total costs and quality-adjusted life-years gained for LCIG vs standard of care were £586,832 vs £554,022, and 2.82 vs 1.43, respectively. The incremental cost-effectiveness ratio for LCIG compared to standard of care was £23,649/quality-adjusted life-year. Results were sensitive to the healthcare resource utilisation based on real-world data, and long-term efficacy of LCIG. Conclusions The base-case incremental cost-effectiveness ratio was estimated to be within the acceptable thresholds for cost effectiveness considered for England.
PubDate: 2022-05-01
- A Comparison of Methods for Identifying Informal Carers: Self-Declaration
Versus a Time Diary-
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Abstract: Objectives Two main methods for identifying whether an individual is an informal carer are self-declaration and the use of a time diary. We analysed the level and predictors of agreement between these two methods among co-residential informal carers of adult recipients. Methods We used the 2014/15 UK Time Use Survey, which is a large-scale household survey for those aged 8 years old and over. It contains an individual questionnaire for self-declaration and a time diary for activity-based identification that records all activity in 10-min slots for two 24-h periods. Our analysis: (i) assesses the degree of overlap across approaches; (ii) explores the differences in characteristics between carers identified via one approach relative to non-carers using a bivariate probit estimator; and (iii) shows what factors are associated with being identified by both approaches using two independent probit estimators. Results Out of 6301 individuals, we identified 545 carers (8.6%) by at least one method and only 104 (19.1% of 545 carers) by both methods. We found similar factors predicted caregiving using either method but the magnitudes of the effects of these factors were larger for self-declared carers. Activity-based carers who provided more activities to a dependent adult and spent more time caregiving were more likely to also self-declare. Conclusions Our results show low levels of agreement between the two main methods used to identify informal carers. Any assessment of current caregiving research or future means to collect caregiving information should pay particular attention to the identification method as it may only relate to certain carer groups.
PubDate: 2022-04-08
- Correction to: Systematic Review of Conceptual, Age, Measurement and
Valuation Considerations for Generic Multidimensional Childhood
Patient-Reported Outcome Measures-
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PubDate: 2022-04-01
- Dramatic Innovations in the Treatment of Spinal Muscular Atrophy, But Many
Unknowns Remain-
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PubDate: 2022-04-01
- Correction to: Mogamulizumab for Previously Treated Mycosis Fungoides and
Sézary Syndrome: An Evidence Review Group Perspective of a NICE Single
Technology Appraisal-
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PubDate: 2022-04-01
- PharmacoEconomics
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PubDate: 2022-03-28
- Correction to: Systematic Literature Review to Assess Economic Evaluations
in Spinal Muscular Atrophy (SMA)-
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PubDate: 2022-02-26
- Correction to: Dramatic Innovations in the Treatment of Spinal Muscular
Atrophy, But Many Unknowns Remain-
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PubDate: 2022-02-25
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