Significant Conflicts Of Interest Research Articles

Plastic Surgeon Familiarity with Female Genital Mutilation and Cutting in the United States.

Plastic Surgeon Familiarity with Female Genital Mutilation and Cutting in the United States.

Conflicts of interest for members of the US 2020 dietary guidelines advisory committee.

To measure incidence of conflicts of interest (COI) with food and pharmaceutical industry actors on the advisory committee for the 2020-2025 US Dietary Guidelines for Americans (DGA) and assess the adequacy of current mechanisms to disclose and manage COI among the committee's members. We compiled longitudinal data from archival sources on connections between members of the DGA's advisory committee and actors. We hypothesised that these committee members, who oversee the science for the most influential dietary policy in the USA, might have significant COI that would be relevant to their decision making. Disclosure of COI on this committee was recommended in 2017 by the National Academies of Sciences in order to increase transparency and manage bias, but public disclosure of the committee's COI does not appear to have taken place. The committee was composed of twenty experts. None. Our analysis found that 95 % of the committee members had COI with the food and/or pharmaceutical industries and that particular actors, including Kellogg, Abbott, Kraft, Mead Johnson, General Mills, Dannon and the International Life Sciences, had connections with multiple members. Research funding and membership of an advisory/executive board jointly accounted for more than 60 % of the total number of COI documented. Trustworthy dietary guidelines result from a transparent, objective and science-based, process. Our analysis has shown that the significant and widespread COI on the committee prevent the DGA from achieving the recommended standard for transparency without mechanisms in place to make this information publicly available.

An Evolutionary Multi-objective Approach for Coordinating Supplier–Producer Conflict in Lot Sizing

Context. This paper deals with bilateral joint decision making in supply chains, and more specifically focuses on coordinating the decisions taken by the supplier and the producer in lot sizing. Research gap. Previous existing works in lot sizing have modeled the coordination task as a bi-level optimization problem. Unfortunately, the bi-level model causes a hierarchy between the two actors by making the leader imposing the decisions that suits his/her interests to the follower. This induces a significant conflict of interest between the two stakeholders because the leaders benefit is always greater than the follower’s one. Objective. The main goal of this work is to attenuate the conflict of interest issue between both actors by proposing a multi-objective model that alleviates the hierarchy and creates a win–win situation. Method. We propose an effective multi-objective lot sizing model, called Supplier-Producer Multi-Objective Lot Sizing (SP-MOLS); that alleviates the hierarchy between the actors’ objectives by assigning them the same importance degree and hence optimizing them simultaneously. The resolution of our SP-MOLS model using the Non-dominated Sorting Genetic Algorithm II (NSGA-II), as an effective meta-heuristic search engine, provides a set of trade-off solutions, each expressing a compromise degree between the two actors: the supplier and the producer. Results. To validate our approach, we use five test problems each containing 100 instances with a planning horizon of 10 periods and we analyze the obtained trade-off solutions using the compromise degree and the gap between costs as main consensus metrics. The obtained results reveal that a small sacrifice in the leader’s benefit could produce a significant improvement in the follower’s one. For instance, a 10% increase of the producer’s cost may generate a 42% decrease in the supplier’s one. Reciprocally, a 0.4% increase of the supplier’s cost may generate a 49% decrease in the producer’s cost. Method algorithmic improvement. As solutions of interests for both stakeholders are usually located within the extreme regions of the Pareto front, we propose NSGA-II with Focus on Extreme Regions (NSGA-II-FER) as a new variant of NSGA-II that focuses the search in the extreme regions of the Pareto front thanks to a modified crowding measure that is adaptively managed during the evolution process. This variant has shown its ability to eliminate dominance-resistant solutions and thus to come up with better extreme regions. Based on the experimental results, NSGA-II-FER is shown to have the ability to provide the decision makers with more convergent and more diversified extreme non-dominated solutions, expressing better trade-off degrees between both actors’ costs. Managerial implications. The promising results obtained by our proposal encourage decision makers’ to adopt a multi-objective approach rather than a bi-level one. From our personal perspective, we recommend running the three models (the multi-objective model and the two bi-levels ones); then analyzing the solutions of all models in terms of compromise degrees and logistic costs. This would allow both actors to observe how the hierarchy incurred by the bi-level models increases conflicts, while the multi-objective one generates solutions with much improved consensus degrees. Such observations will convince the supply chain stakeholders to adopt our multi-objective approach, while keeping an eye on the bi-level models’ solutions and the consensus degrees. Finally, we also recommend focusing on the extreme regions of the Pareto front since they contain rich solutions in terms of consensus. Such solutions are more convincing in the negotiation process and thus could lead to better win–win situations.

Becoming a peer reviewer

Becoming a peer reviewer

Conflicts of Interest in Human Subject Research: The Insufficiency of U.S. and International Standards.

Researchers, as well as individuals and institutions that oversee their conduct, sometimes have conflicts of interest that weaken or render ineffective efforts to protect human research subjects. This article analyzes United States and international standards used to address conflicts of interest and reviews evidence regarding compliance. It finds current standards are insufficient and recommends that the federal government and international organizations adopt stronger legal standards that require resolving most significant conflicts of interest and specifying how to manage conflicts of interest not resolved.

Conflict of interest explains the size of student evaluation of teaching and learning correlations in multisection studies: a meta-analysis.

We examined the associations between the size of student evaluation of teaching and learning (SET/learning) correlations and presence of several conflicts of interest (COIs) including corporate, administrative, evaluation unit, SET author, and funder interests. Our meta-analyses of SET/learning correlations reported by multisection studies show that researchers with a vested interest in finding large positive SET/learning correlations found, on average, large positive SET/learning correlations. In contrast, researchers with no identifiable COIs found that SET/learning correlations were zero or nearly zero. The largest SET/learning correlations were reported by authors with ties to SET selling corporations. Smaller but still substantial SET/learning correlations were reported by researchers with administrative assignments and by researchers in evaluation units/departments responsible for the administration of SET. Moreover, authors with the most significant COIs were publishing their studies primarily prior to 1981 whereas authors with no or less significant COIs were publishing their studies in 1981 or afterwards. Studies published prior to 1981 reported small but significant (r = .31) SET/learning correlations whereas studies published in 1981 and after reported near zero, non-significant SET/learning correlations (r = .06). The presence of COIs was associated with earlier publication date but also with smaller samples. Finally, whereas corporate, administrative, and evaluation unit authors nearly ceased publishing multisection studies on SET/learning correlations, authors from business and economics departments are now responsible for the substantial portion of newer, larger, and higher quality studies published in 1981 and after.

Scope and Prevalence of Conflicts of Interest Among Highly Cited Peripheral Artery Disease Research Studies

Conflicts of interest (COI) potentially influence interpretation of study results for both authors and journal readers. Scientific journals often require author disclosure of relevant conflicts, but this is usually by self-report and seldom includes detailed quantification of reimbursement. The purpose of this analysis was to characterize COI among highly cited research studies related to peripheral artery disease (PAD) in terms of prevalence, quantity of reimbursement, and associations with manuscript characteristics. Highly cited PAD publications from 2012 to 2017 were identified through a Web of Science search using “peripheral artery disease.” Results were then sorted by number of times cited from highest to lowest. Review articles and non-English language publications were excluded. The top 100 most-cited publications were then abstracted for disclosed COI by author. Articles were characterized as basic science or clinical, and clinical publications were subcategorized as observational, medical interventions, or procedural interventions. Disclosures by US authors were queried using the ProPublica Dollars for Docs search tool (linked to the Centers for Medicare and Medicaid Services Open Payments data) based on provider name, specialty, and geographic location. Statistical analysis included descriptive statistics and categorical tests, including the χ2 test. Included publications were cited a mean of 124 ± 200.5 times and had a total of 1137 named authors. A mean of 1.6 ± 4.8 disclosed COI per author were identified. The prevalence of disclosed COI was significantly higher for clinical versus basic science studies (32.1% vs 4.2%; P < .0001). Among the top 10 articles by highest mean number of disclosures per author, the median open payment amount among authors reporting COI was $121,500 (range, $22-$2,630,000), and a total of $1,584,727 in nondisclosed open payments were identified from authors reporting no COI (median, $24,573; range, $12-$457,000). Disclosed COI sorted by journal are shown in the Table. Significant COI were identified among highly cited PAD studies, although the majority of authors reported none. Disclosed COI are significantly more prevalent among clinical versus basic science studies. Authors may have substantial nondisclosed compensation from industry that may be relevant to study results and interpretation. These results suggest that author self-reported COI may be conservatively biased. Readers should consider potential COI, including quantity of author compensation, when interpreting study results.TableMean number of disclosed conflicts of interest (COI) per author among highly cited peripheral artery disease (PAD) studies sorted by journalaJournalJournal Impact Factor (JCR 2017)Total no. of authorsMean COI per authorStandard deviationRangeStroke6.239109.75.50-17New England Journal of Medicine79.258805.990-41Journal of the American College of Cardiology16.8341303.57.10-44American Journal of Medicine5.117234.66.90-21Journal of Endovascular Therapy2.732262.23.50-18Arteriosclerosis Thrombosis and Vascular Biology6.086153.24.50-14JACC Cardiovascular Interventions9.88192.84.40-14Lancet Diabetes and Endocrinology19.313102.53.40-11European Heart Journal23.425462.46.20-30JACC-Cardiovascular Interventions9.881751.94.40-32Circulation18.881311.84.70-37Leukemia10.023161.630-11Annals of Neurology10.244241.14.20-20Journal of the American Medical Association10.244490.82.10-9Catheterization and Cardiovascular Interventions2.60260.50.80-2Journal of the American Society of Nephrology8.655180.51.50-5Journal of Thoracic and Cardiovascular Surgery4.8860.51.20-3Hypertension6.823180.41.40-6Journal of Cardiovascular Surgery1.19550.40.50-1Lancet53.254480.31.60-11Cardiovascular Drugs and Therapy2.77190.20.40-1Journal of Vascular Surgery3.294140.20.60-2Pharmacological Research4.897110.20.40-1Journal of the American Heart Association4.45400.10.20-1aJournals with highly cited studies but zero COI were excluded. Open table in a new tab

Alpha-defensin and the Synovasure lateral flow device for the diagnosis of prosthetic joint infection: a systematic review and meta-analysis.

The aim of this review was to evaluate the available literature and to calculate the pooled sensitivity and specificity for the different alpha-defensin test systems that may be used to diagnose prosthetic joint infection (PJI). Studies using alpha-defensin or Synovasure (Zimmer Biomet, Warsaw, Indiana) to diagnose PJI were identified from systematic searches of electronic databases. The quality of the studies was evaluated using the Quality Assessment of Studies of Diagnostic Accuracy (QUADAS) tool. Meta-analysis was completed using a bivariate model. A total of 11 eligible studies were included. The median QUADAS score was 13 (interquartile range 13 to 13) out of 14. Significant conflicts of interest were identified in five studies. The pooled sensitivity for the laboratory alpha-defensin test was 0.95 (95% confidence interval (CI) 0.91 to 0.98) and the pooled specificity was 0.97 (95% CI 0.95 to 0.98) for four studies with a threshold level of 5.2 mgl-1 The pooled sensitivity for the lateral flow cassette test was 0.85 (95% CI 0.74 to 0.92) and the pooled specificity was 0.90 (95% CI 0.91 to 0.98). There was a statistically significant difference in sensitivity (p = 0.019), but not specificity (p = 0.47). Laboratory-based alpha-defensin testing remains a promising tool for diagnosing PJI. The lateral flow cassette has a significantly lower performance and pooled results are comparable to the leucocyte esterase test. Further studies are required before the widespread adoption of the lateral flow cassette alpha-defensin test. Cite this article: Bone Joint J 2018;100-B:703-11.

Regulating Campaign Finance through Legislative Recusal Rules

Regulating Campaign Finance through Legislative Recusal Rules

Parliamentary Disqualification for Financial Conflicts

When should holding a pecuniary interest bar someone from election to or service in parliament? In ousting Senator Day for breaching s 44(v) of the Constitution, the High Court overruled a long-standing narrow interpretation of that potentially unruly provision. This article seeks to situate the law involved in both its litigational history and in the broader policy question of managing MPs’ financial interests. Hovering behind all this is the problem of the inflexibility of constitutionalising barriers to election and parliamentary service (a problem which engulfed the Australian Parliament in 2017). Section 44(v) bars, from being elected or sitting in the Australian Parliament, anyone who: has any direct or indirect pecuniary interest in any agreement with the Public Service of the Commonwealth [otherwise than as a member of a company of 25 or more people]. The article is structured chronologically. It moves from the narrow reading of s 44(v) by Barwick CJ in Re Webster (1975), on to the broader reading of the High Court in Re Day (No 2) (2017) and the procedurally strangled claim in Alley v Gillespie. It concludes with reflections on the value of a hard but fuzzy constitutional disqualification like s 44(v). Given the rise of pecuniary interest registers and the unfairness of applying disqualification rules to mere candidates, a better, more flexible approach is advocated here. Such an approach would see Parliament set and audit rules about the dealings of serving MPs with the Commonwealth of Australia. That process would involve the assistance of an independent agency such as an Integrity Commissioner. MPs would be suspended, not disqualified, whilst they dealt with any significant conflicts of interest.

Challenges facing the veterinary profession in Ireland: 3. emergency and casualty slaughter certification

BackgroundVeterinarians are faced with significant conflicts of interest when issuing certificates for the transport and slaughter of acutely injured and casualty livestock. In a recent Policy Delphi study, emergency and casualty slaughter certification was a key concern identified by veterinary professionals in Ireland. In this case study (the third in a series of three resulting from a research workshop exploring challenges facing the veterinary profession in Ireland; the other two case studies investigate clinical veterinary services and the on-farm use of veterinary antimicrobials), we aim to provide a value-based reflection on the constraints and opportunities for best practice in emergency and casualty slaughter certification in Ireland.ResultsUsing a qualitative focus group approach, this study gathered evidence from relevant stakeholders, namely a representative from the regulatory body, local authority veterinarians with research experience in emergency slaughter, an animal welfare research scientist, official veterinarians from the competent authority, a private veterinary practitioner, and a member of a farming organisation. Results revealed a conflict between the responsibility of private veterinary practitioners (PVPs) to safeguard the welfare of acutely injured bovines on-farm and the client’s commercial concerns. As a consequence, some PVPs may feel under pressure to certify, for example, an acutely injured animal for casualty slaughter instead of recommending either on-farm emergency slaughter or disposal by the knackery service. Among Official Veterinarians, there are concerns about the pressure within processing plants to accept acutely injured livestock as casualty animals. Confusion pertaining to legislation and definition of fitness to travel also contribute to these dilemmas.ConclusionsConflicts of interest arise due to the gap between governance and provision to facilitate on-farm emergency slaughter of livestock. Increased availability and acceptance of on-farm emergency slaughter by Food Business Operators (FBOs) would mitigate the need to certify acutely injured animals fit for transport and slaughter and thereby safeguard animal welfare. In the absence of nationwide availability and acceptance of on-farm emergency slaughter by FBOs, consideration should be given to methods to encourage all those involved in the food chain to prioritise animal welfare when in conflict with the commercial value of the animal. Training and guidelines for PVPs on the regulatory landscape and ethical decision-making should become available. The reintroduction of the fallen animal scheme should be considered to support farm animal welfare.

Tax Court Dismisses Valuation Expert's Report Due to Conflict of Interest

The US Tax Court, on February 22, issued an opinion valuing two paintings for estate tax purposes (Estate of Kollsman v. Commissioner). We reviewed this opinion because the same valuation process would take place in the nonprofit law context (e.g., valuation of property to determine a charitable contribution deduction). The Tax Court found the analysis of the estate's valuation expert “unreliable and unpersuasive” (along with undervaluing the property by $1.77 million) because, in part, he had a “significant conflict of interest that could cause a reasonable person to question his objectivity.”

Convergence to consensus in heterogeneous groups and the emergence of informal leadership.

When group cohesion is essential, groups must have efficient strategies in place for consensus decision-making. Recent theoretical work suggests that shared decision-making is often the most efficient way for dealing with both information uncertainty and individual variation in preferences. However, some animal and most human groups make collective decisions through particular individuals, leaders, that have a disproportionate influence on group decision-making. To address this discrepancy between theory and data, we study a simple, but general, model that explicitly focuses on the dynamics of consensus building in groups composed by individuals who are heterogeneous in preferences, certain personality traits (agreeability and persuasiveness), reputation, and social networks. We show that within-group heterogeneity can significantly delay democratic consensus building as well as give rise to the emergence of informal leaders, i.e. individuals with a disproportionately large impact on group decisions. Our results thus imply strong benefits of leadership particularly when groups experience time pressure and significant conflict of interest between members (due to various between-individual differences). Overall, our models shed light on why leadership and decision-making hierarchies are widespread, especially in human groups.

Participation in Corporate Governance

Over the last thirty years there has been a remarkable functional convergence in the way companies are run. Behind directors, asset managers and banks usually participate the most in setting the ultimate direction of corporations, as they have assumed the role of stewardship over shareholder voting rights. At the same time, an increasing number of people’s livelihoods and old age now depend on the stock market, but these ultimate contributors to equity have barely any voice. Why has there been such a separation of contribution and participation? Two positive theses explain this convergence in corporate governance, one political, one economic. The first positive thesis is that laws which guarantee participation rights in investment chains (either for shareholders against directors, or for the ultimate contributors against institutional shareholders) were driven by a progressive democratic movement, but very incompletely compared to its social ideals. The second positive thesis is that when there have been no specific rights in law, the relative bargaining power of different groups determined the patterns of participation, whether the outcomes were reasonable or entirely arbitrary. In practice, the separation has grown between those who contribute to equity capital and those who participate in governance. These theses are preferable to existing narratives in political literature, and law and economics, which entail predictions of different forms of rational interest-driven institutional evolution. On the contrary, participation in corporate governance is largely unprincipled. The evidence is found in the historical development of participation rights in the UK, Germany and the US. Does the separation of contribution and participation matter? One normative thesis is derived from the historical evidence. It proposes that the separation of contribution and participation is a pressing concern, precisely because participation in corporate governance, as it stands, manifests no coherent principles. Asset managers and banks have gathered shareholder voting rights through no better reason than their peculiar market position as investment intermediaries. They have significant conflicts of interest when they exercise voting rights with other people’s money. They are able to use votes like any other selfperpetuating interest group would, because they are not effectively accountable to their natural beneficiaries: the ultimate investors. To ensure that the successes of modern corporate law are not unravelled, corporate governance should protect the principle of a symmetry between contribution and participation. This will mean that in the future, corporate governance becomes more economically efficient, sustainable, and just.

Conflicts of Interest in the Publishing Process

Conflicts of Interest in the Publishing Process

Fools’ Gold

Fools’ Gold

An exciting time for Hepatology

An exciting time for Hepatology

Investment Banks and Their Affiliated Mutual Funds: International Evidence from IPO Allocations

We examine the way investment banks allocate IPOs to their affiliated mutual funds worldwide. An underwriter may allocate hot IPOs to its affiliated funds to improve fund performance and increase asset management fees. Alternatively, a bank may allocate to its affiliated mutual funds poorly-performing IPOs that would otherwise be undersubscribed, using affiliates as a “dumping ground” to preserve investment banking fees. We analyze IPO allocations to affiliates globally and find significant cross-country differences in the first-day returns of these IPOs. Although IPOs allocated to affiliated funds outside the U.S have significantly lower first-day returns, IPO allocations to all mutual funds — both affiliated and unaffiliated — in countries with strong investor protection tend to have higher first-day returns, benefiting fund investors. Furthermore, strong investor protection appears to discourage underwriters from allocating IPOs with negative first-day returns to their affiliates. Overall, the evidence suggests the presence of an economically significant conflict of interest within financial conglomerates for which prior literature has not found robust empirical support. Results also highlight the importance of effective investor protection in mitigating this conflict.

When will we ever learn?

Continuous sedation and analgesia are deemed necessary in most intensive care units (ICUs) worldwide, although there is a large variation in clinical practice. The choice of agents and dosing regimes differs. In particular, the patients on mechanical ventilation are considered an important group within the ICU where sedation and analgesia play an important role. The last decades have continuously given us evidence about various unwanted effects of continuous sedation and analgesia: prolonged length of stay in the ICU, prolonged time on mechanical ventilation, difficult weaning, adverse drug effects, drug tolerance and addiction, and long-term adverse effects as increased post-traumatic stress disorders. A study in this issue of Acta Anaesthesiologica Scandinavica reveals common practice about the administration of sedation and analgesia in Norwegian ICUs. This is in many respects disappointing documentation: most respondents (ICU physicians and nurses in charge of the unit) report that in general, the ICUs to a small extent use written protocols for sedation and analgesia, withdrawal protocols or practice daily sedation stop. This is not unique for Norway and probably reflects the attitude in many ICUs worldwide. Why is evidence regarding sedation and analgesia so hard to transform into daily routines in our ICUs? My response to such a question is that this is not a specific problem with sedation and analgesia. ICUs have problems using low tidal volumes in Adult Respiratory Distress Syndrome (ARDS), to give our patients enough nutrition, in particular using the enteral route, and to prevent nosocomial ICU infections, to mention some other important areas. The long and winding road from finding evidence to its use in individual patient care is complex. The message may be lost at several steps along this way. Often evidence from several sources is forged into clinical guidelines. Such guidelines may be produced by hospitals, by national bodies or by professional societies. Often several ‘competing’ guidelines exist. In the prevention and treatment of ventilator-associated pneumonia, there are several recent guidelines at the moment. This complicates the picture, and the quest for the ‘best’ guideline may be difficult. The validity of guidelines is also questioned in various ways. Guidelines may be corrupted, they may be sponsored by the industry or the authors have significant conflicts of interest. In an analysis of guidelines and consensus reports regarding mechanical ventilation, adherence to methodological standards was found to be low. More than half of the reports were either sponsored by industry funding, or the authors declared conflict of interest. Guidelines are also rapidly outdated. In a study from 2007 of 100 published meta-analysis, the median ‘survival’ (time to new evidence that significantly altered the conclusions) was 2.9 years within cardiovascular guidelines and 6.6 years in noncardiovascular guidelines. The next step is the implementation of clinical guidelines into local treatment protocols. Not all guidelines may directly be transferred into the specific clinical setting of individual ICUs and must at least be translated and adopted in various ways. As an example, a suggested drug may not be available in that country, or case mix of the ICU differs considerably form the original population behind the guidelines. To what extent our ICUs really include good and updated clinical guidelines into local routines are largely unknown. The study in this issue of our journal indicates that in most Norwegian ICUs, this is at least not done with regard to sedation and analgesia. Acta Anaesthesiol Scand 2012; 56: 1–2 Printed in Singapore. All rights reserved © 2012 The Author Acta Anaesthesiologica Scandinavica © 2012 The Acta Anaesthesiologica Scandinavica Foundation

Surviving Sepsis Guidelines and Scientific Evidence?

Evidence-based medicine is defined as the conscientious, explicit, and judicious use of the best current scientific evidence in making decisions about the care of individual patients. The practice of evidence-based medicine means integrating clinical acumen with the best available external evidence from systematic research. With MEDLINE adding more than 600 000 new articles a year and ‘‘medical knowledge’’ doubling every 4 years it is nearly impossible for any physician to keep abreast of all the relevant evidence from the existing literature. Clinical practice guidelines aim to bridge the gap between research and practice. Clinical practice guidelines embrace evidence-based medicine by rigorously distilling the highest level of evidence from the literature in an effort to help physicians provide the best possible care to their patients. The principle construct of the guideline development process is that they should be evidence-based and not opinion based, be fully transparent, and that the developers and sponsoring organization/organizations should be free of significant conflict of interest. Unfortunately the methodological quality of clinical practice guidelines developed by different organizations varies considerably, thereby impacting the confidence that we can place in their recommendations. In this issue of the Journal, Stoneking and coauthors using the ‘‘Surviving Sepsis Campaign International Guidelines for Management of Severe Sepsis and Septic Shock’’ as a model, explore physician adherence to guidelines and propose strategies to improve guideline compliance. It is regrettable that the authors used the Surviving Sepsis Campaign Guidelines to explore this topic, as these guidelines fail the most basic test of guideline validity. The major elements of the ‘‘6-hour resuscitation bundle’’ of the Surviving Sepsis Campaign Guidelines include fluid resuscitation to achieve a central venous pressure (CVP) of greater than 8 cm H2O and a central venous oxygen saturation (ScvO2) above 70%, with the use of blood and inotropic agents. While the concept of early resuscitation (as compared to delayed resuscitation) is a scientifically sound concept, there is now increasing recognition that the major elements of the ‘‘6-hour resuscitation bundle’’ are not supported by scientific evidence. Remarkably, the major elements of the 6-hour resuscitation bundle are based on a small (n 1⁄4 263), nonblinded, single-center study (the River’s Early GoalDirected Therapy [EGDT] study), in which the lead author had significant undisclosed conflicts of interest and where the validly of the data has come into question. Barochia and colleagues performed a systemic review of the association between the component therapies of the 6-hour resuscitation bundle and outcome. These authors concluded that the ‘‘current sepsis bundles may force physicians to provide unproven or even harmful care. As administered and studied to date, only antibiotics meet the stated criteria of proof for bundle inclusion.’’ Furthermore, it is noteworthy that the reported hospital mortality of the standard therapy group in the River’s EGDT study was 46%; this compares to 17% in a recent randomized controlled study which evaluated the outcomes of the 6-hour resuscitation bundle. Of significant concern is the fact that these flawed guidelines have been turned into performance measures. The Joint Commission and the Institute of Healthcare Improvement have used adherence to these guidelines (using checklists) as an indicator of quality of care delivered. Checklists are fine if you are a pilot, however, they can become dangerous when providing bed-side care to complex critically ill patients. While aggressive early fluid resuscitation followed by vasoactive agents (in those with persistent hypotension) remains the cornerstone of the management of patients with severe sepsis and septic shock, the end points of resuscitation should be based on validated physiologic variables that are individualized based on each patients’ comorbidities and unique clinical circumstances. The optimal approach to the management of patients with septic shock remains to be determined. It is unlikely that a ‘‘one-size fits all’’ approach will be appropriate for all patients. A number of multicenter, randomized controlled studies (ProCESS, ARISE) are currently