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Journal articles on the topic 'Endpoints'

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Published: 4 June 2021

Last updated: 4 February 2022

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1

Banerjee, Buddhananda, and Atanu Biswas. "True endpoint reduction by surrogate endpoints." Communications in Statistics - Simulation and Computation 46, no. 8 (May 27, 2016): 6645–53. http://dx.doi.org/10.1080/03610918.2016.1171350.

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2

Ferreira-González, Ignacio, and Gaietà Permanyer-Miralda. "Are composite endpoints multilevel endpoints?" Journal of Clinical Epidemiology 61, no. 2 (February 2008): 199–201. http://dx.doi.org/10.1016/j.jclinepi.2007.10.002.

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3

Hahn, Andreas, Andreas Podbielski, Markus M. Heimesaat, Hagen Frickmann, and Philipp Warnke. "Binary surrogate endpoints in clinical trials from the perspective of case definitions." European Journal of Microbiology and Immunology 11, no. 1 (March 30, 2021): 18–22. http://dx.doi.org/10.1556/1886.2020.00031.

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AbstractIntroductionSurrogate endpoints are widely used in clinical trials, especially in situations where the endpoint of interest is not directly observable or to avoid long trial periods. A typical example for this case is frequently found in clinical trials in oncology, where overall survival (OS) as endpoint of interest and progression free survival (PFS) as surrogate endpoint are discriminated.MethodsBased on the perspective of case definitions on surrogate endpoints, we provide a formal definition of such endpoints followed by a description of the structure of surrogate endpoints.ResultsSurrogate endpoints can be considered as case definitions for the endpoint of interest. Therefore, the performance of surrogate endpoints can be described using the classical terminology of diagnostic tests including sensitivity and specificity. Since such endpoints always focus on sensitivity with necessarily reduced specificity, efficacy estimates based on such endpoints are in general biased.ConclusionThe abovementioned has to be taken into account while interpreting the results of clinical trials and should not be ignored while planning or conducting a study.

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4

BOAS, R. A. "ENDPOINTS." Regional Anesthesia and Pain Medicine 23, Sup 1 (May 1998): 116. http://dx.doi.org/10.1097/00115550-199823031-00116.

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5

Kuller, Lewis H. "Clinical trials: surrogate endpoints or hard endpoints?" American Journal of Cardiology 88, no. 2 (July 2001): 59–61. http://dx.doi.org/10.1016/s0002-9149(01)01786-6.

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6

Dowsett, M. "Molecular endpoints." European Journal of Cancer 38, no. 11 (March 2002): S129. http://dx.doi.org/10.1016/s0959-8049(02)80418-x.

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7

ZARET, B. "Soft endpoints." Journal of Nuclear Cardiology 5, no. 3 (June 1998): 243–44. http://dx.doi.org/10.1016/s1071-3581(98)90124-6.

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8

Conti, C. Richard. "Clinical endpoints." Clinical Cardiology 25, no. 7 (July 2002): 311–12. http://dx.doi.org/10.1002/clc.4950250702.

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9

Redmond, J. M. T., and M. J. McKenna. "Neuropathy endpoints." Neurology 46, no. 4 (April 1, 1996): 1193. http://dx.doi.org/10.1212/wnl.46.4.1193.

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10

Ellenberg, SS. "Surrogate endpoints." British Journal of Cancer 68, no. 3 (September 1993): 457–59. http://dx.doi.org/10.1038/bjc.1993.369.

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11

Johnson, C. A. "Psychophysical Endpoints." European Journal of Ophthalmology 9, no. 1_suppl (January 1999): S48—S51. http://dx.doi.org/10.1177/112067219900901s16.

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12

Palileo-Villanueva, Lia M., and Antonio L. Dans. "Composite endpoints." Journal of Clinical Epidemiology 128 (December 2020): 157–58. http://dx.doi.org/10.1016/j.jclinepi.2020.07.017.

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Buyse, M. E., K. J. Punt, C. H. Köhne, P. Hohenberger, R. Labianca, H. J. Schmoll, L. Pahlman, A. F. Sobrero, and J. Y. Douillard. "Endpoints in adjuvant trials: A systematic review of the literature in colon cancer and proposed definitions for future trials." Journal of Clinical Oncology 25, no. 18_suppl (June 20, 2007): 4018. http://dx.doi.org/10.1200/jco.2007.25.18_suppl.4018.

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4018 Background: Disease-free survival (DFS) is the primary endpoint of most trials testing adjuvant treatments. However many other endpoints are used. There is much confusion about these endpoints since different definitions were used among trials, or no definitions were provided at all. Moreover there is no consensus on either the definition of each endpoint or on the most relevant among these endpoints. This creates difficulties when comparing the results of various trials. Methods: Adjuvant trials in colon cancer were used as a model. A systematic review was performed on published adjuvant studies in colon cancer from 1997–2006, and the definitions of endpoints other than overall survival (OS) were recorded. A panel of medical oncologists, surgical oncologists, and a statistician, all with expertise in randomised trials in colorectal cancer, aimed to reach consensus on the definition of the various endpoints as well as to select the most relevant among these. Results: A total of 52 studies were identified. In addition to overall survival 8 other endpoints were used, and both the definition of these endpoints as well as the starting point differed considerably among these studies. No definition was provided for the endpoint in 19 (37%) studies and for the starting point in 30 (58%) studies. The panel reached consensus on the definition of each endpoint ( table ), and agreed that DFS, defined as the time from randomisation to any event irrespective of cause was considered to be the most relevant endpoint for adjuvant studies. The date of randomisation was considered to be the most appropriate starting point. Conclusions: The proposed guideline will help in the design of future adjuvant studies in colon cancer, and will achieve the uniformity required to facilitate cross-study comparisons. It may serve as a model for adjuvant studies in other solid tumors. [Table: see text] No significant financial relationships to disclose.

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Jang, Eun, Jae Suhr, and Ho Jung. "Lane Endpoint Detection and Position Accuracy Evaluation for Sensor Fusion-Based Vehicle Localization on Highways." Sensors 18, no. 12 (December 11, 2018): 4389. http://dx.doi.org/10.3390/s18124389.

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Landmark-based vehicle localization is a key component of both autonomous driving and advanced driver assistance systems (ADAS). Previously used landmarks in highways such as lane markings lack information on longitudinal positions. To address this problem, lane endpoints can be used as landmarks. This paper proposes two essential components when using lane endpoints as landmarks: lane endpoint detection and its accuracy evaluation. First, it proposes a method to efficiently detect lane endpoints using a monocular forward-looking camera, which is the most widely installed perception sensor. Lane endpoints are detected with a small amount of computation based on the following steps: lane detection, lane endpoint candidate generation, and lane endpoint candidate verification. Second, it proposes a method to reliably measure the position accuracy of the lane endpoints detected from images taken while the camera is moving at high speed. A camera is installed with a mobile mapping system (MMS) in a vehicle, and the position accuracy of the lane endpoints detected by the camera is measured by comparing their positions with ground truths obtained by the MMS. In the experiment, the proposed methods were evaluated and compared with previous methods based on a dataset acquired while driving on 80 km of highway in both daytime and nighttime.

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15

Stutchfield, Christopher, Anna Davies, and Amber Young. "Fluid resuscitation in paediatric burns: how do we get it right? A systematic review of the evidence." Archives of Disease in Childhood 104, no. 3 (September 27, 2018): 280–85. http://dx.doi.org/10.1136/archdischild-2017-314504.

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BackgroundOptimal fluid resuscitation in children with major burns is crucial to prevent or minimise burn shock and prevent complications of over-resuscitation.ObjectivesTo identify studies using endpoints to guide fluid resuscitation in children with burns, review the range of reported endpoint targets and assess whether there is evidence that targeted endpoints impact on outcome.DesignSystematic review.MethodsMedline, Embase, Cinahl and the Cochrane Central Register of Controlled Trials databases were searched with no restrictions on study design or date. Search terms combined burns, fluid resuscitation, endpoints, goal-directed therapy and related synonyms. Studies reporting primary data regarding children with burns (<16 years) and targeting fluid resuscitation endpoints were included. Data were extracted using a proforma and the results were narratively reviewed.ResultsFollowing screening of 777 unique references, 7 studies fulfilled the inclusion criteria. Four studies were exclusively paediatric. Six studies used urine output (UO) as the primary endpoint. Of these, one set a minimum UO threshold, while the remainder targeted a range from 0.5–1.0 mL/kg/hour to 2–3 mL/kg/hour. No studies compared different UO targets. Heterogeneous study protocols and outcomes precluded comparison between the UO targets. One study targeted invasive haemodynamic variables, but this did not significantly affect patient outcome.ConclusionsFew studies have researched resuscitation endpoints for children with burns. Those that have done so have investigated heterogeneous endpoints and endpoint targets. There is a need for future randomised controlled trials to identify optimal endpoints with which to target fluid resuscitation in children with burns.

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Tian, Yang, Yanan Wang, Hui Tian, and Qimei Cui. "The Comprehensive Contributions of Endpoint Degree and Coreness in Link Prediction." Complexity 2021 (August 11, 2021): 1–9. http://dx.doi.org/10.1155/2021/1544912.

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In past studies, researchers find that endpoint degree, H-index, and coreness can quantify the influence of endpoints in link prediction, especially the synthetical endpoint degree and H-index improve prediction performances compared with the traditional link prediction models. However, neither endpoint degree nor H-index can describe the aggregation degree of neighbors, which results in inaccurate expression of the endpoint influence intensity. Through abundant investigations, we find that researchers ignore the importance of coreness for the influence of endpoints. Meanwhile, we also find that the synthetical endpoint degree and coreness can not only describe the maximal connected subgraph of endpoints accurately but also express the endpoint influence intensity. In this paper, we propose the DCHI model by synthesizing endpoint degree and coreness and the HCHI model by synthesizing H-index and coreness on SRW-based models, respectively. Extensive simulations on twelve real benchmark datasets show that, in most cases, DCHI shows better prediction performances in link prediction than HCHI and other traditional models.

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Clemence, Dominic P. "Subordinacy Analysis and Absolutely Continuous Spectra for Sturm-Liouville Equations with Two Singular Endpoints." Canadian Mathematical Bulletin 41, no. 1 (March 1, 1998): 23–27. http://dx.doi.org/10.4153/cmb-1998-005-6.

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AbstractThe Gilbert-Pearson characterization of the spectrum is established for a generalized Sturm-Liouville equation with two singular endpoints. It is also shown that strong absolute continuity for the one singular endpoint problem guarantees absolute continuity for the two singular endpoint problem. As a consequence, we obtain the result that strong nonsubordinacy, at one singular endpoint, of a particular solution guarantees the nonexistence of subordinate solutions at both singular endpoints.

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Kelly, Lauren E., Yashwant Sinha, Charlotte I. S. Barker, Joseph F. Standing, and Martin Offringa. "Useful pharmacodynamic endpoints in children: selection, measurement, and next steps." Pediatric Research 83, no. 6 (April 18, 2018): 1095–103. http://dx.doi.org/10.1038/pr.2018.38.

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Abstract Pharmacodynamic (PD) endpoints are essential for establishing the benefit-to-risk ratio for therapeutic interventions in children and neonates. This article discusses the selection of an appropriate measure of response, the PD endpoint, which is a critical methodological step in designing pediatric efficacy and safety studies. We provide an overview of existing guidance on the choice of PD endpoints in pediatric clinical research. We identified several considerations relevant to the selection and measurement of PD endpoints in pediatric clinical trials, including the use of biomarkers, modeling, compliance, scoring systems, and validated measurement tools. To be useful, PD endpoints in children need to be clinically relevant, responsive to both treatment and/or disease progression, reproducible, and reliable. In most pediatric disease areas, this requires significant validation efforts. We propose a minimal set of criteria for useful PD endpoint selection and measurement. We conclude that, given the current heterogeneity of pediatric PD endpoint definitions and measurements, both across and within defined disease areas, there is an acute need for internationally agreed, validated, and condition-specific pediatric PD endpoints that consider the needs of all stakeholders, including healthcare providers, policy makers, patients, and families.

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Pavlovic, Mira, Conor Teljeur, Beate Wieseler, Marianne Klemp, Irina Cleemput, and Mattias Neyt. "ENDPOINTS FOR RELATIVE EFFECTIVENESS ASSESSMENT (REA) OF PHARMACEUTICALS." International Journal of Technology Assessment in Health Care 30, no. 5 (November 2014): 508–13. http://dx.doi.org/10.1017/s0266462314000592.

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Objectives: Clinical endpoints are defined as valid measures of clinical benefit or harm due to treatment, that describe the impact of treatment on how a patient feels, functions, and survives. The choice of endpoints and the manner in which they are reported have a major impact on the relative effectiveness assessment (REA) of pharmaceuticals. The aim of this article is to describe the guideline development process and the key findings that set a framework for appropriate use of endpoints in REAs in Europe.Methods: A multi-health technology assessment (HTA)-agency collaborative process in EUnetHTA JA1 was used to scope, draft, and finalize methodological guidelines for REA in Europe.Results: Patient-relevant clinical endpoints can be broadly categorized into: mortality, morbidity and health-related quality of life. A clinical endpoint is a main symptom or sign of a disease that is clinically relevant, valid, reproducible and responsive to change. Preference is for long-term or final endpoints whenever possible. Surrogate endpoints may be used when there is compelling evidence of a clear and consistent correlation of treatment effects on the surrogate and final outcome of interest.Conclusions: The relevance and hierarchy of the different types of clinical endpoints depend on the research question, disease, and the treatment investigated. Not only the primary endpoint, but also other relevant endpoints are assessed in comparison to adequate comparator(s). This simultaneous assessment of all relevant endpoints is a hallmark of REA.

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20

Waliszewski, Matthias, Mark Rosenberg, Harald Rittger, Viktor Breul, and Florian Krackhardt. "Endpoint selection for noninferiority percutaneous coronary intervention trials: a methodological description." Therapeutic Advances in Cardiovascular Disease 14 (January 2020): 175394472091132. http://dx.doi.org/10.1177/1753944720911329.

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Background: The objective of this review is to provide a practical update on endpoint selection for noninferiority (NI) studies in percutaneous coronary intervention studies. Methods: A PubMed search was conducted for predefined terms to explore the use of NI designs and intrapatient comparisons to determine their current importance. Sample size calculations for the most frequently used endpoints with NI hypotheses were done to increase statistical awareness. Results: Reported NI trials, with the most frequently chosen clinical endpoint of major adverse cardiac events (MACE), had NI margins ranging from 1.66% to 5.00%, resulting in patient populations of 400–1500 per treatment group. Clinical study endpoints comprising of MACE complemented with rates of bleeding complications and stent thrombosis (ST) are suggested to conduct a statistically and clinically meaningful NI trial. Study designs with surrogate endpoints amenable to intrapatient randomizations, are a very attractive option to reduce the number of necessary patients by about half. Comparative clinical endpoint studies with MACE and ST/bleeding rates to study a shortened dual antiplatelet therapy (DAPT) in coronary stent trials are feasible, whereas ST as the sole primary endpoint is not useful. Conclusions: Expanded composite clinical endpoints (MACE complemented by ST and bleeding rates and intrapatient randomization for selected surrogate endpoints) may be suitable tools to meet future needs in device approval, recertification and reimbursement.

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Heller, Glenn, Robert Thomas Mccormack, Thian Kheoh, Matthew Raymond Smith, Robert Dreicer, Fred Saad, Ronald De Wit, et al. "Circulating tumor cell (CTC) number as a response endpoint in metastatic castration resistant (mCRPC) compared with PSA across five randomized phase 3 trials." Journal of Clinical Oncology 35, no. 15_suppl (May 20, 2017): 5007. http://dx.doi.org/10.1200/jco.2017.35.15_suppl.5007.

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5007 Background: Radiographic progression and overall survival (OS) are the traditional clinical benefit measures for mCRPC trials. Reliable indicators of response that occur early are a critical unmet need in practice and clinical research. We explored a week 13 CTC and prostate-specific antigen (PSA) endpoint relative to baseline in 5 prospective randomized phase 3 registration trials that enrolled 5912 pts. OS was the primary endpoint. Methods: CTC number (CellSearch) and PSA values in patients who survived at least 13 weeks were evaluated as response endpoints in COU-AA-301, AFFIRM, ELM-PC-5, ELM-PC-4 and COMET-1. Pts with missing values at week 13 were considered non-responders. The endpoints considered are shown in Table 1. Results: The discriminatory strength of the response endpoints with respect to OS was estimated using the weighted c-index. To summarize discrimination results for each measure, the mean and the standard deviation based on the weighted c-indices from the 5 studies were computed. Conclusions: CTC0 and CTC conversion endpoints had the highest discriminatory power for OS relative to the % decline in CTC or PSA endpoints. The percent of pts eligible and evaluable for the CTC0 endpoint was significantly higher than the conversion endpoint, 75% vs. 51%, respectively. These two absolute measures of CTC can be considered meaningful response indicators in mCRPC clinical trials. [Table: see text] [Table: see text]

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Drexel, Heinz, Giuseppe M. C. Rosano, Basil S. Lewis, Kurt Huber, Alexander Vonbank, Jörn F. Dopheide, Arthur Mader, et al. "The age of randomized clinical trials: three important aspects of randomized clinical trials in cardiovascular pharmacotherapy with examples from lipid and diabetes trials." European Heart Journal - Cardiovascular Pharmacotherapy 6, no. 2 (August 29, 2019): 97–103. http://dx.doi.org/10.1093/ehjcvp/pvz029.

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Abstract Randomized clinical trials (RCTs) are important and the Gold Standard for drugs in modern cardiovascular (CV) therapy. The cornerstone of RCTs is the recording of hard clinical endpoints instead of surrogates. It is important to select an appropriate endpoint. Efficacy endpoints must be clinically relevant and can be hierarchically divided. A very interesting innovation in endpoint acquisition is the total event paradigm.

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Hasnain, Ali, Qaiser Mehmood, Syeda Sana e Zainab, and Aidan Hogan. "SPORTAL." International Journal on Semantic Web and Information Systems 12, no. 3 (July 2016): 134–63. http://dx.doi.org/10.4018/ijswis.2016070105.

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Access to hundreds of knowledge bases has been made available on the Web through public SPARQL endpoints. Unfortunately, few endpoints publish descriptions of their content (e.g., using VoID). It is thus unclear how agents can learn about the content of a given SPARQL endpoint or, relatedly, find SPARQL endpoints with content relevant to their needs. In this paper, the authors investigate the feasibility of a system that gathers information about public SPARQL endpoints by querying them directly about their own content. With the advent of SPARQL 1.1 and features such as aggregates, it is now possible to specify queries whose results would form a detailed profile of the content of the endpoint, comparable with a large subset of VoID. In theory it would thus be feasible to build a rich centralised catalogue describing the content indexed by individual endpoints by issuing them SPARQL (1.1) queries; this catalogue could then be searched and queried by agents looking for endpoints with content they are interested in. In practice, however, the coverage of the catalogue is bounded by the limitations of public endpoints themselves: some may not support SPARQL 1.1, some may return partial responses, some may throw exceptions for expensive aggregate queries, etc. The authors' goal in this paper is thus twofold: (i) using VoID as a bar, to empirically investigate the extent to which public endpoints can describe their own content, and (ii) to build and analyse the capabilities of a best-effort online catalogue of current endpoints based on the (partial) results collected.

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Revankar, Sanjay G., William R. Kirkpatrick, Robert K. McAtee, Annette W. Fothergill, Spencer W. Redding, Michael G. Rinaldi, and Thomas F. Patterson. "Interpretation of Trailing Endpoints in Antifungal Susceptibility Testing by the National Committee for Clinical Laboratory Standards Method." Journal of Clinical Microbiology 36, no. 1 (1998): 153–56. http://dx.doi.org/10.1128/jcm.36.1.153-156.1998.

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Trailing endpoints remain a problem in antifungal susceptibility testing using the National Committee for Clinical Laboratory Standards (NCCLS) method. For isolates for which trailing endpoints are found, MICs of ≤1 μg/ml at 24 h and of >64 μg/ml at 48 h are usually observed. In a study of human immunodeficiency virus (HIV)-infected patients with oropharyngeal candidiasis, we identified three patients with multiple serial isolates for which trailing endpoints were observed with fluconazole. At 24 h, MICs were generally ≤1 μg/ml by both broth macro- and microdilution methods. However, at 48 h, MICs were >64 μg/ml, while the organism remained susceptible by agar dilution testing with fluconazole. Most episodes of oropharyngeal candidiasis with trailing-endpoint isolates responded to doses of fluconazole as low as 100 mg/day. Two patients had both susceptible and trailing-endpoint isolates by NCCLS broth macro- and microdilution testing; these isolates were found to be the same strain by pulsed-field gel electrophoresis using restriction fragment length polymorphisms. Another patient had two different strains, one for which trailing endpoints were observed and one which was susceptible at 48 h. Trailing endpoints may be seen with selected isolates of a strain or may be a characteristic finding for most or all isolates of a strain. In addition, with isolates for which trailing endpoints are observed, reading the endpoint for the NCCLS method at 24 h may be more appropriate.

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Gao, Tianrun, and Xuzhen Zhu. "Link prediction based on the powerful combination of endpoints and neighbors." International Journal of Modern Physics B 34, no. 28 (August 4, 2020): 2050269. http://dx.doi.org/10.1142/s0217979220502690.

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Performance improvement of topological similarity-based link prediction models becomes an important research in complex networks. In the models based on node influence, researchers mainly consider the roles of endpoints or neighbors. Through investigations, we find that an endpoint with large influence has many neighbors. Meanwhile, the neighbors connect with more nodes besides endpoint, meaning that the endpoint can transmit extensive influence by the powerful combination of itself and neighbors. In addition, we evaluate the node influence by degree because the degree represents the number of neighbors accurately. In this paper, through focusing on the degree of endpoints and neighbors, we propose the powerful combination of endpoints and neighbors (PCEN) model. Experiments on twelve real network datasets demonstrate that the proposed model has better prediction performances than the traditional models.

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Banerjee, Amitava, Laurent Fauchier, Anne Bernard-Brunet, Nicolas Clementy, and Gregory Y. H. Lip. "Composite risk scores and composite endpoints in the risk prediction of outcomes in anticoagulated patients with atrial fibrillation." Thrombosis and Haemostasis 111, no. 03 (2014): 549–56. http://dx.doi.org/10.1160/th13-12-1033.

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SummarySeveral validated risk stratification schemes for prediction of ischaemic stroke (IS)/thromboembolism (TE) and major bleeding are available for patients with non-valvular atrial fibrillation (NVAF). On the basis for multiple common risk factors for IS/TE and bleeding, it has been suggested that composite risk prediction scores may be more practical and user-friendly than separate scores for bleeding and IS/TE. In a long-term prospective hospital registry of anticoagulated patients with newly diagnosed AF, we compared the predictive value of existing risk prediction scores as well as composite risk scores, and also compared these risk scoring systems using composite endpoints. Endpoint 1 was the simple composite of IS and major bleeds. Endpoint 2 was based on a composite of IS plus intracerebral haemorrhage (ICH). Endpoint 3 was based on weighted coefficients for IS/TE and ICH. Endpoint 4 was a composite of stroke, cardiovascular death, TE and major bleeding. The incremental predictive value of these scores over CHADS2 (as reference) for composite endpoints was assessed using c-statistic, net reclassification improvement (NRI) and integrated discrimination improvement (IDI). Of 8,962 eligible individuals, 3,607 (40.2%) had NVAF and were on OAC at baseline. There were no statistically significant differences between the c-statistics of the various risk scores, compared with the CHADS2 score, regardless of the endpoint. For the various risk scores and various endpoints, NRI and IDI did not show significant improvement (≥1%), compared with the CHADS2 score. In conclusion, composite risk scores did not significantly improve risk prediction of endpoints in patients with NVAF, regardless of how endpoints were defined. This would support individualised prediction of IS/TE and bleeding separately using different separate risk prediction tools, and not the use of composite scores or endpoints for everyday ‘real world’ clinical practice, to guide decisions on thromboprophylaxis.Note: The review process for this paper was fully handled by Christian Weber, Editor in Chief.

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Goodrich, Cindy. "Endpoints of Resuscitation." AACN Advanced Critical Care 17, no. 3 (July 1, 2006): 306–16. http://dx.doi.org/10.4037/15597768-2006-3008.

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Major resuscitation goals in the management of shock include restoration of adequate tissue perfusion and oxygen balance and normalization of cellular metabolism. Identification of the most appropriate endpoints of resuscitation is difficult and often debated in the literature. Traditional endpoints, such as heart rate, blood pressure, mental status, and urine output are useful in the initial identification of inadequate perfusion, but are limited in their ability to identify ongoing, compensated shock. Many clinicians continue to use these parameters as indicators that systemic oxygenation imbalances have resolved, even though they have been found to be poor indicators of ongoing tissue hypoxia. Additional resuscitation endpoints that more closely evaluate the adequacy of perfusion and oxygenation at the tissue level should also be used when managing the critically ill. Selected endpoints should include a variety of global and regional indicators to guide and evaluate the effectiveness of treatment.

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Mattson, Richard H. "Monotherapy trials: endpoints." Epilepsy Research 45, no. 1-3 (May 2001): 109–17. http://dx.doi.org/10.1016/s0920-1211(01)00232-7.

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Chadwick, David. "Monotherapy trials: endpoints." Epilepsy Research 45, no. 1-3 (May 2001): 119. http://dx.doi.org/10.1016/s0920-1211(01)00233-9.

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Whitehead, John. "Monotherapy trials: endpoints." Epilepsy Research 45, no. 1-3 (May 2001): 121–22. http://dx.doi.org/10.1016/s0920-1211(01)00234-0.

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31

Cestero, Ramon F., and Daniel L. Dent. "Endpoints of Resuscitation." Surgical Clinics of North America 95, no. 2 (April 2015): 319–36. http://dx.doi.org/10.1016/j.suc.2014.10.004.

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32

Hughes, Michael D. "Evaluating surrogate endpoints." Controlled Clinical Trials 23, no. 6 (December 2002): 703–7. http://dx.doi.org/10.1016/s0197-2456(02)00264-7.

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Goodrich, Cindy. "Endpoints of Resuscitation." AACN Advanced Critical Care 17, no. 3 (July 2006): 306–16. http://dx.doi.org/10.1097/01256961-200607000-00010.

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34

Connelly, Christopher R., and Martin A. Schreiber. "Endpoints in resuscitation." Current Opinion in Critical Care 21, no. 6 (December 2015): 512–19. http://dx.doi.org/10.1097/mcc.0000000000000248.

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Tseng, George S., and Michael H. Wall. "Endpoints of Resuscitation." Seminars in Cardiothoracic and Vascular Anesthesia 18, no. 4 (February 3, 2014): 352–62. http://dx.doi.org/10.1177/1089253213520348.

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Aldridge, Susan. "New Alzheimer's endpoints?" Nature Biotechnology 26, no. 5 (May 2008): 482. http://dx.doi.org/10.1038/nbt0508-482a.

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Vaduganathan, Muthiah, Stephen J. Greene, Javed Butler, and Mihai Gheorghiade. "Endpoints for Diuresis." Journal of the American College of Cardiology 63, no. 8 (March 2014): 838–39. http://dx.doi.org/10.1016/j.jacc.2013.04.108.

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Alhabib, Nada, and Lasse Rempe-Gillen. "Escaping Endpoints Explode." Computational Methods and Function Theory 17, no. 1 (July 5, 2016): 65–100. http://dx.doi.org/10.1007/s40315-016-0169-8.

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Niehaus, Ines, and Charalabos-Markos Dintsios. "OP135 Confirmatory Versus Explorative Endpoints In Drug Approval Versus Health Technology Assessment." International Journal of Technology Assessment in Health Care 33, S1 (2017): 63–64. http://dx.doi.org/10.1017/s0266462317001945.

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INTRODUCTION:The early benefit assessment of drugs in Germany and their preceded market authorization pursue different objectives, resulting in divergent decision-making strategies. This is reflected inter alia by the diverse inclusion of confirmatory endpoints within the assessments of oncological drugs. The pharmaceutical manufacturers are facing the challenge of meeting the requirements for both evaluation processes by the available evidence and avoiding hereby negative early benefit assessments. This is mainly due to the concept of mutually relevant clinical trials.METHODS:Identification and gathering of the endpoints is based on a specifically developed guide. The extracted data from the documents of completed assessments up to July 2015 are used to estimate both separately and together the impact of explorative in relation to confirmatory endpoints on the drug approval and early benefit assessment, by contrasting the European Medicines Agency's risk-benefit-ratio and the benefit-harm-balancing of the national Health Technology Assessment (HTA) jurisdiction.RESULTS:Twenty-one of fourty-one studies’ oncological assessments could be included in the endpoint analysis. From a procedural point of view both the drug approval and the early benefit assessment seem to be not confirmatory since they include explorative endpoints as well. Yet, drug approval is in terms of quality of endpoints more confirmatory than early benefit assessment since it contains a higher proportion of primary endpoints. The latter implies only in 67 percent of the assessments a primary endpoint to be relevant for the benefit-harm-balancing. Moreover, explorative mortality endpoints reached the highest agreement and explorative endpoints capturing health-related quality of life no agreement, referring to the mutual relevance of endpoints for the risk-benefit-ratio and the benefit-harm-balancing.CONCLUSIONS:The missing information transparency of the assessment reports compared to the information offered within the early benefit assessment makes an assignment of endpoints with respect to the mutually relevant clinical trial sometimes troublesome. To warrant, in the long run, a broader confirmatory basis for decisions in health care supported by HTA, a closer inter-institutional cooperation of approval authorities and German HTA jurisdictions seems favorable.

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Ying, Jian, Andrew Redd, and Tom Greene. "2091." Journal of Clinical and Translational Science 1, S1 (September 2017): 22–23. http://dx.doi.org/10.1017/cts.2017.92.

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OBJECTIVES/SPECIFIC AIMS: The objective of this research is to determine under what conditions endpoints based on estimated glomerular filtration rate (eGFR) slope or on relatively small declines in eGFR provide valid and useful surrogate endpoints for pivotal clinical trials in chronic kidney disease (CKD) patients. METHODS/STUDY POPULATION: We consider 2 classes of surrogate endpoints. The first class includes endpoints defined by the average rate of change in eGFR during defined portions of the follow-up period of the trial, following initiation of the randomized treatment interventions. The second class includes composite endpoints defined by the time from randomization until the occurrence of a designated decline in eGFR or kidney failure. The true clinical endpoint is considered to be the time from randomization until kidney failure, irrespective of the trajectory in eGFR measurements prior to kidney failure. We apply statistical simulation to determine conditions under which alternative endpoints within the 2 classes are (1) valid surrogate endpoints, in the sense of preserving a low probability of rejecting the null hypothesis of no treatment effect on the surrogate endpoint when there is no treatment effect on the clinical endpoints and are also (2) useful surrogate endpoints, in the sense of providing increased statistical power that allows significant reductions in sample size and/or duration of follow-up. Input parameters for the simulations include (a) characteristics of the joint distribution of the longitudinal eGFR measurements and the time to occurrence of renal failure, (b) characteristics of the short-term and long-term effects of the treatment, and (c) design parameters, including the duration of accrual and follow-up and the spacing of eGFR measurements during the follow-up period. We use joint analyses of 19 treatment comparisons across 13 previous clinical trials of CKD patients to guide the selection of input parameters for the simulations. We apply longitudinal mixed effects models for analysis of endpoints based on eGFR slope, and Cox regression for analyses of the composite time-to-event endpoints. RESULTS/ANTICIPATED RESULTS: We have previously shown that surrogate endpoints defined by eGFR declines of 30% or 40% can provide valid and useful alternative endpoints in CKD clinical trials for interventions that do not produce short-term effects on eGFR which differ from the longer-term effects of the interventions. Other factors influencing the validity and utility of these endpoints include the average baseline eGFR, the mean rate of change in eGFR, and the extent to which the size of the treatment effect depends on the patient’s underling rate of eGFR decline. We will extend these results by presenting preliminary results describing conditions under which outcomes based on eGFR slope provide valid and useful alternatives to the clinical endpoint of time until occurrence of kidney failure. DISCUSSION/SIGNIFICANCE OF IMPACT: The statistical simulation strategy described in this research can be used during the design of clinical trials of chronic kidney disease to assist in the selection of endpoints that maximize savings in sample size and duration of follow-up while retaining a low risk of producing a false positive conclusion in the absence of a true effect of the treatment on the time until kidney failure.

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Le Tourneau, C., S. Michiels, H. Gan, and L. Siu. "Reporting of endpoints and tracking of failures in randomized trials of radiotherapy or concurrent chemoradiotherapy for locally advanced head and neck squamous cell cancer (LA-HNSCC)." Journal of Clinical Oncology 27, no. 15_suppl (May 20, 2009): 6072. http://dx.doi.org/10.1200/jco.2009.27.15_suppl.6072.

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6072 Background: Due to their anatomical complexity, the interactive effects of multiple treatment modalities, the difficulties in differentiating scar tissues versus residual disease and second cancers versus tumor recurrence, LA-HNSCC represent a challenging disease for the reporting of endpoints and the tracking of failures. Methods: We retrieved all randomized trials that began accrual on or after 1978, and enrolled previously untreated nonmetastatic HNSCC patients receiving primary (chemo)radiotherapy. The reporting of endpoints and the tracking of failures in these trials were analyzed. Failures were defined as events meeting a pre-specified endpoint definition. Results: Forty trials involving 13,892 patients fulfilled our inclusion criteria. A total of 125 endpoints were identified: primary versus secondary = 34:91, survival-based (e.g., overall survival [OS]) versus surrogate (e.g. locoregional control [LRC]) = 47:78. In 6 trials, no primary endpoint was identified. LRC and OS accounted for 70% of primary endpoints. All but one trial reported at least one secondary endpoint, with a median of 2 per trial (range: 0–5), and as many as 17 different types of secondary endpoints were reported. Among 72 endpoints tracking locoregional failures, 21/72 (29%) did not define locoregional failure, while 46/72 (64%) specified the absence of complete response as a failure. Whether salvage surgery or elective node dissection was performed or not was reported in less than half of the trials. Furthermore, it was usually not specified if residual disease found during these procedures would account for failure or not. The means (i.e. clinical and/or radiological examinations) to ascertain failures and the protocol-specified timing to track failures were reported in 41% and 67% of surrogate endpoints, respectively. The tracking of other types of failure beyond the first failure is not reported by any of the trials. The reporting of second cancers was found in 15/40 (38%) trials, whereas the duration of follow-up was quantified in 31/40 (78%) trials. Conclusions: These results demonstrate the vast heterogeneity in endpoint reporting and tracking of failures in clinical trials of LA-HNSCC. No significant financial relationships to disclose.

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Neyedli, Heather F., and Timothy N. Welsh. "People are better at maximizing expected gain in a manual aiming task with rapidly changing probabilities than with rapidly changing payoffs." Journal of Neurophysiology 111, no. 5 (March 1, 2014): 1016–26. http://dx.doi.org/10.1152/jn.00163.2013.

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Previous research has shown that humans can select movements that achieve their goals, while avoiding negative outcomes, by selecting an “optimal movement endpoint.” This optimal endpoint is modeled based on the participants' endpoint variability and the payoffs associated with the target and penalty regions within the environment. Although the values associated with our goals vary on a moment-to-moment basis in our daily interactions, the adaptation of endpoint selection to changing payoffs in laboratory-based tasks has been examined by varying contexts between blocks of trials. The present study was designed to determine whether participants adjust endpoints and aim to optimal endpoints and whether performance differs when probability or payoff parameters change from trial to trial. Participants aimed to a target circle that was partially overlapped by a penalty circle. They received 100 points for hitting the target and lost points for hitting the penalty area. The magnitude of the penalty value or the distance between the centers of the circles (related to the probability of target and penalty contact) was changed randomly from trial to trial in separate blocks. Results revealed that participants shifted their endpoint and generally aimed optimally when the distance between the circles was varied but did not optimally shift their endpoints when the penalty value was varied. The results suggest that participants rapidly adapted endpoints when the probabilities associated with the task change, because the spatial parameters are an intrinsic property of the visual stimuli that are tightly linked with the motor system, whereas consistent feedback may be necessary to adjust to value parameters effectively.

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Iwahashi, H., K. Fujita, and Y. Takahashi. "Bioasay for chemical toxicity using yeast Saccharomyces cerevisiae." Water Science and Technology 42, no. 7-8 (October 1, 2000): 269–76. http://dx.doi.org/10.2166/wst.2000.0578.

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Multi-endpoint bioassay is a system for gathering information relative to the effects of newly synthesized chemicals and pollutants in the environment. To develop the multi-endpoint bioassay system, we estimated the effects of chemicals on growth ability (IC50), viability (LD50), stress protein induction, prion mutation, mitochondrial mutation, and chromosomal mutation using the yeast Saccharomyces cerevisiae as a model organism. These endpoints showed characteristic values to 32 kinds of reference chemicals, and we classified the chemicals into seven groups according to the endpoints. We concluded that the yeast system has the potential to be a multi-endpoint bioassay relative to human health and the ecosystem in general.

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Kapustka, Lawrence A. "Microbial Endpoints: The Rationale for their Exclusion as Ecological Assessment Endpoints." Human and Ecological Risk Assessment: An International Journal 5, no. 4 (August 1999): 691–96. http://dx.doi.org/10.1080/10807039.1999.9657733.

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Dobler, Claudia C., Rebecca L. Morgan, Yngve Falck-Ytter, Victor M. Montori, and M. Hassan Murad. "Assessing the validity of surrogate endpoints in the context of a controversy about the measurement of effectiveness of hepatitis C virus treatment." BMJ Evidence-Based Medicine 23, no. 2 (February 26, 2018): 50–53. http://dx.doi.org/10.1136/bmjebm-2017-110852.

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Surrogate endpoints are often used in clinical trials, as they allow for indirect measures of outcomes (eg, shorter trials with less participants). Improvements in surrogate endpoints (eg, reduction in low density lipoprotein cholesterol, normalisation of glycated haemoglobin) achieved with an intervention are, however, not always associated with improvements in patient-important outcomes. The common tendency in evidence-based medicine is to view results based on surrogate endpoints as less certain than results based on long term, final patient-important outcomes and rate them as ‘lower quality evidence’. However, careful appraisal of the validity of a surrogate endpoint as a measure of the final, patient-important outcome is more useful than an automatic judgement. In this guide, we use a contemporary and currently highly debated example of the surrogate endpoint ‘sustained viral response’ (ie, viral eradication considered to represent successful treatment) in patients treated for chronic hepatitis C virus. We demonstrate how the validity of a surrogate endpoint can be critically appraised to assess the quality of the evidence (ie, the certainty in estimates) and the implications for decision-making.

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Bar-Zohar, D., F. Agosta, D. Goldstaub, and M. Filippi. "Magnetic resonance imaging metrics and their correlation with clinical outcomes in multiple sclerosis: a review of the literature and future perspectives." Multiple Sclerosis Journal 14, no. 6 (July 2008): 719–27. http://dx.doi.org/10.1177/1352458507088102.

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Magnetic resonance imaging (MRI) has revolutionized the diagnosis and management of patients with multiple sclerosis (MS). Conventional MRI metrics are employed as primary endpoints in proof-of-concept clinical trials evaluating new drugs for MS and as secondary endpoints in definitive phase III trials. Metrics derived from non-conventional MRI techniques are now emerging and hold significant promise since they appear to be more correlated with the most disabling features of MS. However, none of these has been approved for use as a surrogate endpoint for accumulation of physical disability, which is the most important clinical endpoint of this disease. Taking into account the large numbers of patients needed, the extensive exposure to placebo, and the relatively long duration required for phase III clinical trials to show a meaningful effect on progression of disability, the need for a valid, reliable, and objective paraclinical marker of disease evolution cannot be overemphasized. This paper reviews the most up-to-date data regarding MRI techniques, their relationship with central nervous system pathology, as well as with clinical endpoints, and proposes future insights into the use of MRI metrics as surrogate endpoints in clinical trials of MS.

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Tian, Yang, Han Li, Xuzhen Zhu, and Hui Tian. "Link prediction based on combined influence and effective path." International Journal of Modern Physics B 33, no. 22 (September 10, 2019): 1950249. http://dx.doi.org/10.1142/s0217979219502497.

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Link prediction based on topological similarity in complex networks obtains more and more attention both in academia and industry. Most researchers believe that two unconnected endpoints can possibly make a link when they have large influence, respectively. Through profound investigations, we find that at least one endpoint possessing large influence can easily attract other endpoints. The combined influence of two unconnected endpoints affects their mutual attractions. We consider that the greater the combined influence of endpoints is, the more the possibility of them producing a link. Therefore, we explore the contribution of combined influence for similarity-based link prediction. Furthermore, we find that the transmission capability of path determines the communication possibility between endpoints. Meanwhile, compared to the local and global path, the quasi-local path balances high accuracy and low complexity more effectually in link prediction. Therefore, we focus on the transmission capabilities of quasi-local paths between two unconnected endpoints, which is called effective paths. In this paper, we propose a link prediction index based on combined influence and effective path (CIEP). A large number of experiments on 12 real benchmark datasets show that in most cases CIEP is capable of improving the prediction performance.

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Bryan-Brown, CW, and K. Dracup. "Outcomes, endpoints, and expectations." American Journal of Critical Care 5, no. 2 (March 1, 1996): 87–89. http://dx.doi.org/10.4037/ajcc1996.5.2.87.

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Lozes, Étienne, and Jules Villard. "Shared Contract-Obedient Endpoints." Electronic Proceedings in Theoretical Computer Science 104 (December 14, 2012): 17–31. http://dx.doi.org/10.4204/eptcs.104.3.

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Gallagher, E. John. "Metaanalytic Revision of Endpoints." Annals of Emergency Medicine 34, no. 1 (July 1999): 91–95. http://dx.doi.org/10.1016/s0196-0644(99)70277-5.

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