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It is often claimed that Ecclesiastes constitutes an irremediable enigma which flies in the face of traditional Hebrew cosmology, making the author's intended meaning not much more than a bewildering speculative task. Biblical scholars disagree on just about every aspect of this ancient Hebraic work: authorship, date, structure, narrative framework, and even its connection to a Creator God. This essay utilizes Ballantine's strategic rhetorical perspective to introduce and wade through some of the central controversies and debates about the meaning of Ecclesiastes: Is earthly life meaningful or meaningless ? Is there eternal meaning to earthly life or not? Is the earthly life of human beings pointless and futile or not? If the simple pleasures of earthly life are gifts from God, then how can earthly life itself be 'hevel'? and more. Somewhat surprisingly, it concludes that Ecclesiastes is anything but an enigma when viewed rhetorically, and certainly not in contravention of basic Hebraic and Christian biblical principles about the sovereign importance of believing in God and obeying the Commandments, even despite all the trials and tribulations offered by earthly life. [ABSTRACT FROM AUTHOR]

Background: Quantitative futility is an appraisal of the risk of failure of a treatment. For those who do not survive, a laparotomy has provided negligible therapeutic benefit and may represent a missed opportunity for palliation. The aim of this study was to define a timeframe for quantitative futility in emergency laparotomy and investigate predictors of futility using the National Emergency Laparotomy Audit (NELA) database. Methods: A two-stage methodology was used; stage one defined a timeframe for futility using an online survey and steering group discussion; stage two applied this definition to patients enrolled in NELA December 2013–December 2020 for analysis. Futility was defined as all-cause mortality within 3 days of emergency laparotomy. Baseline characteristics of this group were compared to all others. Multilevel logistic regression was carried out with potentially clinically important predictors defined a priori. Results: Quantitative futility occurred in 4% of patients (7442/180,987). Median age was 74 years (range 65–81 years). Median NELA risk score was 32.4% vs. 3.8% in the surviving cohort (p < 0.001). Early mortality patients more frequently presented with sepsis (p < 0.001). Significant predictors of futility included age, arterial lactate and cardiorespiratory co-morbidity. Frailty was associated with a 38% increased risk of early mortality (95% CI 1.22–1.55). Surgery for intestinal ischaemia was associated with a two times greater chance of futile surgery (OR 2.67; 95% CI 2.50–2.85). Conclusions: Quantitative futility after emergency laparotomy is associated with quantifiable risk factors available to decision-makers preoperatively. These findings should be incorporated qualitatively by the multidisciplinary team into shared decision-making discussions with extremely high-risk patients. [ABSTRACT FROM AUTHOR]

Time is man's element as it flows ceaselessly to bring about changes in life. For Larkin, time is a double-edged weapon. It has destroying forces and devastating powers to bring changes in life against human wish. In time's flow, life, that starts with birth and traverses through childhood, youth, manhood, old age, and decrepitude to culminate in death, turns mortal on one side. It turns life futile or void and fills life with disappointments and frustrations by shattering dreams, expectations, hopes, wants etc in its flow. It has a dual goal as the double-edged weapon to turn life to mortality and futility. Man fails miserably as it conquers him by turning life into mortality and futility: so he concurs with it as a double-edged weapon. Life exists in linear time-dimension and time with invincible powers governs life. It is the mystery or the riddle of time. [ABSTRACT FROM AUTHOR]

The article discusses the issue of "futility" in therapy and sheds light on specific treatment situations at the end of life, with incapacitated adults and with a desire for maximal therapy. Ineffective measures have no effect in favor of the treatment goal, contraindicated measures harm the patient, and measures with an unfavorable benefit-risk ratio do not need to be included in the decision-making process unless the patient asks for them. Doctors must explain their assessments transparently and inform the patient unless there is no reasonable doubt about the evaluation. In end-of-life situations, life-sustaining measures should be replaced by palliative measures. In the case of incapacitated patients, a patient representative should be involved in the decision-making process. [Extracted from the article]

Objective: To scope the literature to ascertain the components of palliative care (PC) interventions for burn patients, models of integration, and outcomes. Methods: Arksey and O'Malley scoping review design with narrative synthesis was employed and reported following the PRISMA-ScR guidelines. Primary studies reporting PC interventions in the burn unit were considered for inclusion. CINAHL via EBSCO, PubMed, EMBASE via OVID, Web of Science, and gray literature sources were searched from inception to June 2021. Results: Fifteen studies emerging from high-income settings were retained. Data were organized around three concepts: components of palliative/ end of life care in the burn unit; models of integration; and outcomes. The components of interventions based on the Robert Wood Johnson Foundation Critical Care End-of Life Group domains include decision-making, communication, symptom management and comfort care, spiritual support, and emotional and practical support for families. Consultative and integrative models were noted to be the strategies for integrating PC in the burn unit. The outcomes were varied with only few studies reporting healthcare staff related outcomes. Conclusion: PC may have the potential of improving end-of-life care in the burn unit albeit the limited studies and lack of standardized outcomes makes it difficult to draw stronger conclusions regarding what is likely to work best in the burn unit. [ABSTRACT FROM AUTHOR]

Early recurrences and deaths after a morbid procedure like pelvic exenteration are devastating events. The present study aimed at determining the incidence and predictors of futile pelvic exenterations. Consecutive pelvic exenterations for advanced and recurrent rectal adenocarcinomas operated between January 2013 and January 2021 were included with a minimum of six months follow-up. Futility of exenteration was defined as recurrence or death within six months of operation. Multivariate logistic regression was used to define predictors of futility. Two-hundred eighty-five patients were included and 61 patients (21.4%) had a futile resection. Poorly differentiated (or signet) histology, presence of lateral pelvic nodes, M1 disease, and the need for pelvic bone resections predicted a futile resection. The probability of futility was 10%, 20%, 35–40%, 55–60%, and >75% when none, one, two, three, and all four of the predictors were present. The model was able to correctly predict futility in 70% of the cases suggesting moderate discrimination, and showed good calibration. Futile pelvic exenterations were observed in one-fifth of patients. Four strong predictors of futility were identified. The risk of early failures was additive when combination of these adverse features was present, and can be used for patient selection and prognostication. [ABSTRACT FROM AUTHOR]

Background: The number of older patients with multiple comorbidities in the emergency service is increasingly frequent, which implies the risk of incurring in futile surgical interventions. Some interventions generate false expectations of survival or quality of life in patients and families and represent a negligible therapeutic benefit in patients whose chances of survival are minimal. In order to address this dilemma, we describe mortality in a cohort of patients undergoing emergency laparotomy with a risk ≥ 75% per the ACS NSQIP Surgical Risk Calculator. Methods: A retrospective observational study was designed to analyze postoperative mortality and factors associated with postoperative mortality in a cohort of patients undergoing emergency laparotomy between January 2018 and December 2021 in a high-complexity hospital who had a mortality risk ≥ 75% per the ACS NSQIP Surgical Risk Calculator. Results: A total of 890 emergency laparotomies were performed during the study period, and 50 patients were included for the analysis. Patient median age was 82.5 (IQR: 18.25) years old and 33 (66.00%) were male. The most frequent diagnoses were mesenteric ischemia 21 (42%) and secondary peritonitis 18 (36%). Mortality in the series was 92%. Twenty-four (54.34%) died within the first 24 h of the postoperative period; 11 (23.91%) within 72 h and 10 (21.73%) within 30 days. APACHE II and SOFA scores were statistically significantly higher in patients who died. Conclusions: All available tools should be used to make decisions, with the most reliable and objective information possible, and be particularly vigilant in patients at extreme risk (mortality risk greater than 75% according to ACS NSQIP Surgical Risk Calculator) to avoid futility and its consequences. The available information should be shared with the patient, the family, or their guardians through an assertive and empathetic communication strategy. It is necessary to insist on a culture of surgical ethics based on reflection and continuous improvement in patient care and to know how to accompany them in order to have a proper death. [ABSTRACT FROM AUTHOR]

Purpose: Adjusting therapeutic efforts is an evidence-based clinical decision that aims to avoid medical futility. Varied factors that can influence this decision-making have been pointed out, related to the patient, the medical professional who makes the decisions, system barriers, culture, and the economy, among others. The present study aims to identify those factors that help the specialists working in a cancer referral institution in Colombia to plan actions that improve the approach to decision-making regarding the adequacy of therapeutic efforts in cancer patients. Methodology: This qualitative design is based on 13 in-depth interviews with Colombia's National Cancer Institute specialists. Results: Three women and ten men participated, with an average age of 36 years; seven belonged to the specialty of adult oncology, two to pediatric oncohematology, one to adult intensive care, and three to pediatric intensive care. The factors found were grouped into four categories: 1) knowledge, 2) aspects related to decision-making, 3) the decision-maker, and 4) the type of decision made. These categories were clustered into themes that allude to the factors swaying specialists' decision-making to adjust therapeutic efforts. Conclusion: Adjusting therapeutic actions is vital to avoid futile medical procedures that prolong suffering. Some factors that influence the specialists' decision-making were noted: lack of preparation of health professionals on end-of-life decision-making, reduced use of scales to improve prognostic information, and ignorance about advance directives. These factors must be strengthened to improve the approach to this issue. [ABSTRACT FROM AUTHOR]

Background: A resurgence of research into phase II trial design in the mid-2000s led to the use of futility designs in a wide variety of disease areas. Phase II futility studies differ from efficacy studies in that their null hypothesis is that treatment, relative to control, does not meet or exceed the level of benefit required to justify additional study. A rejection of the null hypothesis indicates that the treatment should not proceed to a larger confirmatory trial.Methods: Bayesian approaches to the design of phase II futility clinical trials are presented and allow for the quantification of key probabilities, such as the predictive probability of current trial success or even the predictive probability of a future trial's success.Results: We provide an illustration of the design and interpretation of a phase II futility study constructed in a Bayesian framework. We focus on the operating characteristics of our motivating trial based on a simulation study, as well as the general interpretation of trial outcomes, type I, and type II errors in this framework.Conclusions: Phase II futility clinical trials, when designed under in a Bayesian framework, offer an alternative approach to the design of mid-phase studies which provide unique benefits relative to trials designed in a frequentist framework and designs which focus on treatment efficacy. [ABSTRACT FROM AUTHOR]

Transfer of trauma patients whose injuries are deemed unsurvivable, often results in early death or transition to comfort care and could be considered misuse of health care resources. This is particularly true where tertiary care resources are limited. Identifying riskfactors for and predicting futile transfers could reduce this impact and help to optimize triage and management. A retrospective study of interfacility trauma transfers to a single rural Level I rauma center from 2014 to 2019. Futility was defined as death, hospice, or declaration of comfort measures within 48 h of transfer without procedural or radiographic intervention at the accepting center. Multiple logistic regressions identified independent predictors of futile transfers. The predictive power of Mechanism,Glasgow coma scale, Age, and Arterial pressure (MGAP), an injury severity score based on Mechanism, Glasgow coma scale, Age, and systolic blood Pressure, were evaluated. Of the 3368 trauma transfers, 37 (1.1%) met criteria as futile. Futile transfers occurred among patients who were significantly older with falls as the most common mechanism. Age, Glasgow coma scale, systolic blood Pressure and Injury Severity Score were significant (P < 0.05) independent predictors of futile transfer. MGAP had a high predictive power area under the receiver operating characteristic (AUROC 0.864, 95% confidence interval 0.803-0.925) for futility. A small proportion (1.1%) of transfers to a rural Level I trauma center met criteria for futility. Predictive tools, such as MGAP scoring, can provide objective criteria for evaluation of transfer necessity and prompt care pathways that involve pre-transfer communications, telemedicine, and/or patient centered goals of care discussions. Such tools could be used in conjunction with a more granular assessment regarding potential operational barriers to reduce futile transfers and to enhance optimization of resource utilization in low-resource service areas. • The rate of futile interfacility transfers to a rural Level I trauma center is 1.1%. • Age, GCS, SBP, and ISS were found to be significant predictors of futile transfer. • Predictive tools could be used to evaluate for futility and inform triage. [ABSTRACT FROM AUTHOR]

Objective: Frailty is a clinically recognizable state of increased vulnerability common in critical medicine. When underrecognized, it may lead to invasive treatments that do not serve the patients' best interest. Our aim was to evaluate the use of both palliative care consultation and invasive interventions in frail patients admitted to Intensive Care Units in Portugal. Methods: This was a prospective, observational study. All consecutive adult patients admitted for more than 24 h, over a 15-day period were enrolled. Twenty-three Portuguese Intensive Care Units were included. Informed consent was obtained from all patients or their surrogate. The doctor and nurse in charge calculated the Clinical Frailty Score as well as the reference family member Results: A total of 335 patients were included in the study (66% male). Mean age was 63.2 ± 16.8 and SAPS II score was 41.8 ± 17.4. Mean Clinical Frailty Score value was 3.5 ± 1.7. Frailty prevalence (mean score ≥ 5) was 20.9%. Frail patients were offered organ support therapy (64,3% invasive mechanical ventilation; 24,3% renal replacement therapy; 67,1% vasopressors) more often than non-frail patients. Nevertheless, limitation of therapeutic effort or a do not resuscitate order (p < 0.001) were more common in frail patients. Mortality rate by 6 months was higher among frail patients (50% vs. 32.3%, p < 0.001). Palliative Care was offered to only 15% of frail patients (3.9% overall). Conclusions: The authors suggest that palliative care should be universally consulted once frailty is identified in critical patients. [ABSTRACT FROM AUTHOR]

When is a fertility treatment futile? This question has great practical importance, given the role futility plays in ethical, legal and clinical discussions. Here, we outline a novel method of determining futility for IVF treatments. Our approach is distinctive for considering the economic value attached to the intended aim of IVF treatments, i.e. the birth of a child, rather than just the effects on prospective parents and the health system in general. We draw on the commonly used metric, quality-adjusted life years (QALYs), to attach a monetary value to new lives created through IVF. We then define futility as treatments in which the chance of achieving a live birth is so low that IVF is no longer a cost-effective intervention given the economic value of new births. This model indicates that IVF treatments in which the chance of a live birth are <0.3% are futile. This suggests IVF becomes futile when women are aged between 47 and 49 years of age. This is notable older than ages currently considered as futile in an Australian context (∼45). In the UK, government subsidized treatment with the couple's own gametes stops at the age of 42, while privately funded treatments are self-regulated by individual providers. In most European countries and the USA, the 'age of futility' is likewise managed by clinical consensus. [ABSTRACT FROM AUTHOR]

Copyright of Basic Education College Magazine For Educational & Humanities Sciences is the property of Republic of Iraq Ministry of Higher Education & Scientific Research (MOHESR) and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Massive transfusion protocols were developed to deliver blood for life-threatening haemorrhage; however, there are no guidelines to advise when massive transfusion protocols may be considered futile. Early recognition of clinical futility remains a challenge as studies have not identified variables that can accurately determine early mortality. As blood is a scarce resource, efforts to distribute it equitably to all patients who would benefit are of paramount importance. In this editorial we discuss recent data and various aspects important in developing and implementing tools that assist with determining futility in massive transfusion. [ABSTRACT FROM AUTHOR]

Larkin as man and poet finds time as man’s element. Time is not an abstract idea but a moving force. Life is rooted in time with “eroding agents”. Life initiating with birth looks into the future as seen from childhood. It traverses from the future to the present and finally to the past. Time is practical for him as fate to a fatalist, reason for a rationalist and the divine to a theist or spiritualist. Time has mysterious powers to turn life into mortality and futility. In life, birth initiates childhood to have all expectations about the future, proceed to manhood or womanhood to find them unfulfilled in the present that turns into the past. He treats the past as the uneventful experience. He considers childhood in his middle age “forgotten boredom” and “unspent”. His poetry reflects the past sans sentimentality. [ABSTRACT FROM AUTHOR]

Neurosurgeons commonly encounter futility of care decisions in their practice. Are these decisions being made with adequate consideration? What is the preparation of neurosurgical trainees for making these decisions? The advent of the COVID-19 pandemic with its extreme pressure on resources and, in particular, intensive care unit beds, has prompted many health care providers including neurosurgeons to consider more fully the potentially futile nature of some treatments and how we might better manage limited resources for the future. We review the concept of futility in neurosurgery and suggest potential solutions to the multiple challenges that arise. [ABSTRACT FROM AUTHOR]

The concept of futility in medicine refers to the incapability of an intervention to achieve its goal. Futility determinations form the basis for withholding and withdrawing life-sustaining interventions. Criticisms of attempted futility definitions relate to inconstant probability and value judgements concerning the goal pursued. This variability frustrates efforts to define futility. Language modifications and procedural approaches, both important ancillary measures, inherently lack the ability to resolve this difficulty. Beneath the notion of futility lie foundational factors whose revised understanding is required to advance a definition. These factors include autonomy, death and the goals of medicine. Reconsidering the essence and influence of foundational factors is necessary to move beyond a seemingly irresolvable problem. In this essay, I assert that defining futility is not pointless but rather possible, necessary and unavoidable. With this assertion, I respond to the criticisms of futility. These responses together with a corrective understanding of foundational factors lead to a definition of futility. This definition balances respect for patients' autonomy whilst allowing for interventions that do not undermine the essence of medicine and integrity of those practising it. Defining futility is an exercise in necessity requiring renewed perceptual foundations. [ABSTRACT FROM AUTHOR]

Background: Massive transfusions are associated with a high mortality rate, but there is little evidence indicating when such efforts are futile. The purpose of this study was to identify clinical variables that could be used as futility indicators in massively transfused patients. Methods: We retrospectively analyzed 138 adult surgical patients at our institution receiving a massive transfusion (2016–2019). Peak lactate and nadir pH within 24 h of massive transfusion initiation, along with other clinical variables, were assessed as predictors of the primary outcome, in‐hospital mortality. Results: The overall rate of in‐hospital mortality among our patient population was 52.9% (n = 73). Increasing lactate and decreasing pH were associated with greater mortality among massively transfused patients. Mortality rates were ~2‐fold higher for patients in the highest lactate category (≥10.0 mmol/L: 25 of 37; 67.6%) compared to the lowest category (0.0–4.9 mmol/L: 17 of 48; 35.4%) (p =.005), and ~2.5‐fold higher for patients in the lowest pH category (<7.00: 8 of 9; 88.9%) compared to the highest category (≥7.40: 8 of 23; 34.7%) (p =.016). Increasing age was also associated with higher mortality (≥65 years: 24 of 33; 72.7%) when compared to younger patients (18–64 years: 49 of 105; 46.7%) (p =.010). Conclusions: Peak lactate ≥10.0 mmol/L, nadir pH <7.00, and age ≥65 years were significantly associated with higher rates of in‐hospital mortality among massively transfused patients. Incorporating these clinical parameters into a futility index for massive transfusions will be useful in situations where blood products are scarce and/or mortality may be unavoidable. [ABSTRACT FROM AUTHOR]

Copyright of L'Année Ronsardiennne is the property of Classiques Garnier and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Introduction: Intensive care units are contexts in which, due to the remarkable existence of particularly technological resources, interventions are promoted to extend the life of people who experience highly complex health situations. This ability can lead to a culture of death denial where the possibility of implementing futile care and treatment cannot be excluded. Objective: To describe nurses' perceptions of adult intensive care units regarding the therapeutic futility of interventions implemented to persons in critical health conditions. Method: Review of the literature following the Scoping Review protocol of the Joanna Briggs Institute. The Population, Concept, and Context mnemonic was used to elaborate the research question and the research was performed using the EBSCOHost search engine in the CINAHL Complete databases, MEDLINE Complete, Cochrane Central Register of Controlled Trials, and Cochrane Database of Systematic Reviews to identify studies published between 1990 and 2019. Seven studies were selected. Results: Nurses consider that therapeutic futility, a current problem in adult intensive care units, may have a negative impact on persons in critical health conditions and that contributes directly to resource expenditure and moral conflicts and consequently leads to emotional exhaustion. Conclusion: Due to the complexity of this concept, knowing and understanding people's and families' perceptions is crucial to the decision-making process, for which reason nurses can play a key role in managing these situations. [ABSTRACT FROM AUTHOR]

Despite the massification of higher education, social inequality in higher education outcomes still persists. It is known that secondary schools' socioeconomic composition is at least partly responsible for this social inequality. Nevertheless, the mechanisms by which socioeconomic composition affects higher education enrollment are still poorly understood. Based on the attribution theory, this study expects students' feelings of academic self-efficacy and sense of futility to act as underlying mechanisms. Additionally, given that individual self-efficacy beliefs and individual sense of futility are shared among students within schools — that is, schools have different self-efficacy and futility cultures — we investigate whether these cultures are consequential for higher education enrollment and program choice. Results of binomial logistic multilevel analyses on the data of the International Study of City Youth (www.iscy.org) in Ghent, consisting of 1214 Flemish students across 29 schools, indicated that students in low socioeconomic composition schools are less likely to enroll in higher education because these schools are characterized by high futility cultures. In contrast, high self-efficacy and self-efficacy cultures are positively associated with the choice for academic bachelor programs, but they did not explain socioeconomic composition effects. We conclude that educational policies should aim at increasing a sense of control over academic outcomes in order to improve social equality in higher education outcomes. [ABSTRACT FROM AUTHOR]

Purpose: To characterize perceptions of palliative versus futile care in interventional radiology (IR) as a roadmap for quality improvement. Methods: Interventional radiologists (IRs) and referring physicians were recruited for anonymous interviews and/or focus groups to discuss their perceptions and experiences related to palliative verse futile care in IR. Sessions were recorded, transcribed, and systematically analyzed using dedicated software, content analysis, and grounded theory. Data collection and analysis continued simultaneously until additional interviews stopped revealing new themes: 24 IRs (21 males, 3 females, 1–39 years of experience) and 7 referring physicians (3 males, 4 females, 6–14 years of experience) were analyzed. Results: Many IRs (75%) perceived futility as an important issue. Years of experience (r = 0.60, p = 0.03) and being in academics (r = 0.62, p = 0.04) correlated with greater perceived importance. Perceptions of futility and whether a potentially inappropriate procedure was performed involved a balance between four sets of factors (patient, clinician, procedural, and cultural). These assessments tended to be qualitative in nature and are challenged by a lack of data, education, and consistent workflows. Referring clinicians were unaware of this issue and assumed IR had guidelines for differentiating between palliation and futility. Conclusion: This study characterized the complexity and qualitative nature of assessments of palliative verses futile care in IR while highlighting potential means of improving current practices. This is important given the number of critically ill patients referred to IR and costs of potentially inappropriate interventions. [ABSTRACT FROM AUTHOR]

Futility denotes failure to achieve the projected outcome. We investigated the prevalence, predictors, and clinical risk model of transcatheter aortic valve implantation (TAVI)-related futility. We included 464 consecutive patients undergoing TAVI from 2010 to 2017. Futility was defined as death and/or hospitalization for heart failure (HFH) within 1 year after TAVI. Of 464 patients (mean age: 84.4 years), 69% were females (EuroSCOREII: 6.3%; Society of Thoracic Surgeons [STS] score: 6.9%). Forty-six patients (9.9%) experienced TAVI-related futility, and 36 of 46 patients (69.6%) died within 1 year due to cardiac (37.5%) and non-cardiac (62.5%) causes. Previous HFH (hazard ratio [HR], 2.20; 95% confidence interval [CI]: 1.13–4.35, p = 0.020), chronic obstructive pulmonary disease (COPD) (HR, 3.39; 95% CI: 1.12–8.42, p = 0.033), and moderate/severe mitral or tricuspid regurgitation (HR, 2.98; 95% CI: 1.32–6.27, p = 0.010) were independent predictors of futility. With 1 point assigned to each predictor (total 0 point, futility low-risk; total 1 point, futility intermediate-risk; total 2–3 points, futility high-risk), the futility risk model clearly stratified individual futility risk into three groups (the freedom from futility at 1 year: 96.2%, 82.1%, and 67.9% each). Our futility risk model presented better discrimination than EuroSCOREII, and STS score (c-statistic: 0.73 vs. 0.68 vs. 0.67). Medical futility was recognized in 9.9% of patients undergoing TAVI. Previous HFH, COPD, and concomitant atrioventricular regurgitation were associated with futility. The risk model derived from three predictors showed good performance in predicting futility risk. [ABSTRACT FROM AUTHOR]

Sequential monitoring of efficacy and safety is an important part of clinical trials. A Group Sequential design allows researchers to perform interim monitoring after groups of patients have completed the study. Statistical literature is well developed for continuous and binary outcomes and relies on asymptotic normality of the test statistic. However, in the case of time-to-event data, existing methods of sample size calculation are done either assuming proportional hazards or assuming exponentially distributed lifetimes. In scenarios where these assumptions are not true, as evidenced from historical data, these traditional methods are restrictive and cannot always be used. As interim monitoring is driven by ethical, financial, and administrative considerations, it is imperative that sample size calculations be done in an efficient manner keeping in mind the specific needs of a clinical trial with a time-to-event outcome. To address these issues, a novel group sequential design is proposed using the concept of Proportional Time. This method utilizes the generalized gamma ratio distribution to calculate the efficacy and safety boundaries and can be used for all distributions that are members of the generalized gamma family using an error spending approach. The design incorporates features specific to survival data such as loss to follow-up, administrative censoring, varying accrual times and patterns, binding or non-binding futility rules with or without skips, and flexible alpha and beta spending mechanisms. Three practical examples are discussed, followed by discussion of the important aspects of the proposed design. [ABSTRACT FROM AUTHOR]

Copyright of Journal of College of Languages is the property of Republic of Iraq Ministry of Higher Education & Scientific Research (MOHESR) and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Annali di Igiene, Medicina Preventiva e di Comunità is the property of Societa Editrice Universo s.r.l. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Interim analyses are routinely used to monitor accumulating data in clinical trials. When the objective of the interim analysis is to stop the trial if the trial is deemed futile, it must ideally be conducted as early as possible. In trials where the clinical endpoint of interest is only observed after a long follow-up, many enrolled patients may therefore have no information on the primary endpoint available at the time of the interim analysis. To facilitate earlier decision-making, one may incorporate early response data that are predictive for the primary endpoint (eg, an assessment of the primary endpoint at an earlier time) in the interim analysis. Most attention so far has been given to the development of interim test statistics that include such short-term endpoints, but not to decision procedures. Existing tests moreover perform poorly when the information is scarce, eg, due to rare events, when the cohort of patients with observed primary endpoint data is small, or when the short-term endpoint is a strong but imperfect predictor. In view of this, we develop an interim decision procedure based on the conditional power approach that utilizes the short-term and long-term binary endpoints in a framework that is expected to provide reliable inferences, even when the primary endpoint is only available for a few patients, and has the added advantage that it allows the use of historical information. The operational characteristics of the proposed procedure are evaluated for the phase III clinical trial that motivated this approach, using simulation studies. [ABSTRACT FROM AUTHOR]

Between Erich Auerbach and Walter Benjamin, there existed a remarkable friendship, which on the one hand manifested itself as an unobtrusive disputation, and yet which on the other hand could be considered an unintended collaboration toward an old-new ideal of philology. Auerbach claims that with the Divine Comedy of Dante Alighieri, Western European literature reached the climax of the figuralism that Auerbach, if belatedly, wants to bring to the fore. Benjamin, in contrast, finds energy for the revolution in the surrealistic love that traces back not to Dante, but to the Provençal poetry which Auerbach regards merely as preliminary to Danteʼs literary achievement. In his The Origin of German Tragic Drama, Benjamin highlights the concept of creatureliness, whose significance for his philosophy of history is no less than that of justice. Auerbach, for his part, does not find its expression in the Germany of the 17th century, but in the France of the 16th century, namely in the work of Michel de Montaigne. However, Montaigneʼs creatureliness is rooted in sermo humilis, which is best embodied in the story of Peter who denied his Lord Jesus Christ three times. By contrast, German creatureliness detects its dissolution in the idea of natural theatre that Benjamin locates in the work of Franz Kafka. Sermo humilis is the perfection of figuralism, whereas the idea of natural theatre means reversal of allegory. The perfected figuralism and the reversed allegory cooperate in the idea of the philology of instead (Philologie des Stattdessen), whose task it is to make bygone the futility of worldly things. [ABSTRACT FROM AUTHOR]

Beci Carver identifies the heir of literary naturalism in the 'granular' modernism of Joseph Conrad, Evelyn Waugh, William Gerhardie, Henry Green, W.H. Auden, T.S. Eliot and Samuel Beckett. Characterized by the performance of plotlessness, arbitrariness, miscellaneousness, and futility, 'granular' modernism is seen to make a virtue of naturalism's tendency towards amorphousness and irrelevance. Finding cognates in early twentieth-century photography, Carver discloses a modernist literary tradition which - unlike the modernism of James Joyce, Ezra Pound, Virginia Woolf, and others - refuses to generate meaning from inconsequent detail. Incipient in the work of Conrad, this tradition is seen to reach its zenith in the midcentury fiction of Beckett. [ABSTRACT FROM AUTHOR]

The concept of futility has been debated for many years, and a precise definition remains elusive. This is not entirely unsurprising given the increasingly complex and evolving nature of modern medicine. Progressively more complex decisions are required when considering increasingly sophisticated diagnostic and therapeutic interventions. Allocating resources appropriately amongst a population whose expectations continue to increase raises a number of ethical issues not least of which are the difficulties encountered when consideration is being given to withholding 'life-preserving' treatment. In this discussion we have used decompressive craniectomy for severe traumatic brain injury as a clinical example with which to frame an approach to the concept. We have defined those issues that initially lead us to consider futility and thereafter actually provoke a significant discussion. We contend that these issues are uncertainty, conflict and consent. We then examine recent scientific advances in outcome prediction that may address some of the uncertainty and perhaps help achieve consensus amongst stakeholders. Whilst we do not anticipate that this re-framing of the idea of futility is applicable to all medical situations, the approach to specify patient-centred benefit may assist those making such decisions when patients are incompetent to participate. [ABSTRACT FROM AUTHOR]

Background: Despite long-standing problems in decisions to stop clinical trials, stopping guidelines are often vague or unspecified in the trial protocol. Clear, well-conceived guidelines are especially important to assist the data monitoring committees for effectiveness trials.Main Text: To specify better stopping guidelines in the protocol for such trials, the clinical investigators and trial statistician should carefully consider the following kinds of questions: 1. How should the relative importance of the treatment benefits and hazards be assessed? 2. For decisions to stop a trial for benefit: (a) What would be the minimum clinically important difference for the study population? (b) How should the probability that the benefit exceeds that difference be assessed? (c) When should the interim analyses include data from other trials? (d) Would the evidence meet state-of-the-art standards for treatment recommendations and practice guidelines? 3. Should less evidence be required to stop the trial for harm than for benefit? 4. When should conventional stopping guidelines for futility be used for comparative effectiveness trials?Conclusion: Both clinical and statistical expertise are required to address such challenging questions for effectiveness trials. Their joint consideration by clinical investigators and statisticians is needed to define better stopping guidelines before starting the trial. [ABSTRACT FROM AUTHOR]

William Lane Craig argues that both God and immortality are required for life to have meaning; life is futile without either of the two. I argue that combining William Lane Craig's arguments for the futility of life without God or immortality, together with a plausible amendment to his working definition of 'futility', entails the counterintuitive conclusion that life is futile if God does exist. Craig says that God must exist as a guarantor of ultimate justice, and that this ultimate 'fairness' is necessary for life to have meaning. I will argue that this ultimate 'fairness' entails that our lives are futile, since, given the existence of God, our actions are causally irrelevant to the achievement of the satisfaction of the 'Good'. This discussion serves to pinpoint a major flaw in Craig's reasoning: the claim that events of merely 'relative' significance do not have the potential to counter the futility of life. [ABSTRACT FROM AUTHOR]

Objective: To determine live-birth rates (LBRs) at various ages in very poor prognosis patients, who are defined as poor responders under the Bologna criteria.Design: Retrospective cohort study.Setting: Academically affiliated private fertility center.Patient(s): Among 483 patients, who under the Bologna criteria (three or fewer oocytes, >40 years of age, and/or antimüllerian hormone [AMH] <1.1 ng/mL [2/3 criteria minimum]) were poor responders, 278 (381 fresh IVF cycles) qualified for the study because they had at least one embryo on day 3 for transfer.Intervention(s): IVF cycles in women with low functional ovarian reserve, involving androgen and CoQ10 supplementation and ovarian stimulation with daily gonadotropin dosages of 300-450 IU of FSH and 150 IU of hMG in microdose agonist cycles.Main Outcome Measure(s): Age-specific LBRs per ET.Result(s): Ages did not differ between nonelective (ne) single ET (SET), ne2-ET, and ne ≥ 3-ET cycles (41.3 ± 3.9, 41.7 ± 3.1, and 42.4 ± 2.1 years, respectively). Patients with neSETs demonstrated significantly lower AMH and higher FSH levels and required higher gonadotropin dosages than ne2-ET and ne ≥ 3-ET patients. LBRs declined with age. Above age 42, three or more embryos are required to achieve reasonable LBRs and two or more to avoid futility under American Society for Reproductive Medicine (ASRM) guidelines.Conclusion(s): Very poor prognosis patients can still achieve acceptable pregnancy rates at least till their mid-40s if they reach ET. The degree to which egg donation is emphasized as the only treatment option in such patients, therefore, requires reconsideration. Above age 42, at least two, and preferably three embryos, are however required to exceed futility, as defined by ASRM. [ABSTRACT FROM AUTHOR]

Background Publicly funded trials regularly fail to recruit their target sample size or find a significant positive result. Adaptive clinical trials which may partly mediate against the problems are not often applied. In this paper we investigate the potential of a form of adaption in a clinical trial - a futility analysis - to see if it has potential to improve publicly funded trials. Methods Outcome data from trials funded by two UK bodies, the Health Technology Assessment (HTA) programme and the UK Medical Research Council (MRC), were collected. These data were then used to simulate each trial with a single futility analysis using conditional power, undertaken after 50% to 90% of the patients had been recruited. Thirty-three trials recruiting between 2002 and 2008 met the inclusion criteria. Stopping boundaries of conditional powers of 20%, 30% and 40% were considered and outcomes included the number of trials successfully stopped and number of patients saved. Results Inclusion of a futility analysis after 75% of the patients had been recruited would have potentially resulted in 10 trials, which went on to have negative results, correctly stopping for futility using a stopping boundary of 30%. A total of 807 patients across all the trials would potentially have been saved using these futility parameters. The proportion of studies successfully recruiting would also have increased from 45% to 64%. Conclusions A futility assessment has the potential to increase efficiency, save patients and decrease costs in publicly funded trials. While there are logistical issues in undertaking futility assessments we recommend that investigators should aim to include a futility analysis in their trial design wherever possible. [ABSTRACT FROM AUTHOR]

Since its inception in the 1980s 'futility' has been a controversial concept. The history of this concept, its definition and application to burns care are discussed from the perspective of a burn surgeon. Although introduced as an objective (value-free) criterion, futility proves impossible to objectivate and judgements about the value of human life always play a role. The roles of the patient, the doctor, the 'politician' and society at large in futility-decisions are discussed. [ABSTRACT FROM AUTHOR]

Abstract: Having the potential to stop a clinical trial early for futility during an interim analysis is an important feature of sequential clinical trials. Conditional power and predictive power methods are widely used to analyze interim data in determining whether a trial is likely to eventually demonstrate both statistically significant and clinically meaningful results. Herein we introduce a new approach to early stopping in clinical trial designs, which can be viewed as a hybridization of the conditional and predictive power methods and has both methods as its special cases. The proposed hybridization, along with a novel resampling method, can be used together to assess futility in sequential trials with time-to-event outcomes. The proposed approach to futility assessment applies to sequential clinical trials with interim analyses planned at either fixed calendar times or number of events. In addition, it does not resort to asymptotics and applies to general test statistics of either single or multiple dimensions. [Copyright &y& Elsevier]

In surgical practice we are often confronted with ethically challenging situations when treating patients not capable of expressing their own wishes. Issues of futile treatment by indicating operations arise particularly with regard to severe dementia. The concept of futility describes forms of therapy which are not appropriate to improve the patient’s condition, but for application in clinical practice the concept is insufficiently defined. In ethically challenging situations, e.g. in the treatment of severely demented patients, we need to balance the medical condition and prognosis with the documented or assumed wishes of the patients. Involving the relatives competently is essential. The indication for surgery in patients with severe dementia, for example, needs to be individualized striving for optimal care, a clear communication about treatment goals with the relatives and preventing distress and burnout for staff. Co-operation with specialists in medical ethics is recommended. [ABSTRACT FROM AUTHOR]

Most discussions of medical futility try to answer the Futility Question: when is a medical procedure futile? No answer enjoys universal support. Some futility policies say that the health care provider will answer this question when the provider and patient (or surrogate decisionmaker) cannot agree. This raises the Decision Question: who has the moral authority to decide what to do in cases where futility is disputed? I look for a procedural answer to this question, an answer that does not turn on whether a given party happens to answer the Futility Question correctly. I argue that these policies get it right; the provider should decide because providers have a right of conscientious refusal that extends to refusing procedures on grounds of futility. This is a procedural answer because providers have this right even if they are sincerely mistaken about whether a procedure is futile. [ABSTRACT FROM AUTHOR]

Youth workers often pride themselves on the degree to which they share power with clients, encounter clients on their own terms, and allow young people to set the tone for and direct the helping relationship. In their descriptions of not-knowing, however, many youth workers mention acute discomfort at the feeling of control having been stripped away from them rather than willingly surrendered or shared. This chapter describes the second of five themes associated with youth workers' experiences of not knowing what to do: the loss of control and features of despair. In addition to presenting the dominant theme of helplessness and loss of control, this chapter discusses the three variations on the theme, as described by youth worker participants: (a) There was nothing there to protect me, (b) Something else just took control of everything, and (c) What does he have to do, kill someone?! [ABSTRACT FROM AUTHOR]

Trauma has been perceived by the public as occurring as an isolated event, always resulting in favorable outcomes. There has therefore been a lack of discussion of futility of care and termination of care when dealing with the sick trauma patient. Several stages exist where issues of futility and early termination of care must be considered. These include the prehospital set- ting and involve the emergency medical service system in recognizing those patients who are nonsurvivors. Next is in the emergency room, where heroic measures may not benefit the very sick patient. In the operating room, the surgeon must always reassess and recognize when massive resuscitation will not benefit a particular trauma patient. Lastly, the intensivist must recognize those patients who may or may not benefit from continued efforts to sustain life. [ABSTRACT FROM AUTHOR]

Neonatologists and parents usually agree when intensive treatment should be stopped. We describe the management of two babies where there was disagreement between the parents and hospital staff, and discuss the medical, legal and ethical implications of the two cases. [ABSTRACT FROM AUTHOR]

Despite substantial controversy, the use of futility judgments in medicine is quite common, and has been backed by the implementation of hospital policies and professional guidelines on medical futility. The controversy arises when health care professionals (HCPs) consider a treatment futile which patients or families believe to be worthwhile: should HCPs be free to refuse treatments in such a case, or be required to provide them? Most physicians seem convinced that professional autonomy protects them from being forced to provide treatments they judge medically futile, given the lack of patient benefit as well as the waste of medical resources involved. The argument from professional autonomy has been presented in a number of articles, but it has not been subjected to much critical scrutiny. In this paper I distinguish three versions of the argument: 1) that each physician should be free to exercise his or her own medical judgment; 2) that the medical profession as a whole may provide futility standards to govern the practice of its members; and 3) that the moral integrity of each physician serves as a limit to treatment demands. I maintain that none of these versions succeeds in overcoming the standard objection that futility determinations involve value judgments best left to the patients, their designated surrogates, or their families. Nor do resource considerations change this fact, since they should not influence the properly patient-centered judgment about futility. [ABSTRACT FROM AUTHOR]

Life saving or life sustaining treatment may not be instigated in the clinical setting when such treatment is deemed to be futile and therefore not in the patient's best interests. The concept of futility, however, is related to many assumptions about quality and quantity of life, and may be relied upon in a manner that is ethically unjustifiable. It is argued that the concept of futility will remain of limited practical use in making decisions based on the best interests principle because it places such high demands on the individual responsible for decision making. This article provides a critical analysis of futility (in the context of the best interests decision-making principle), and proposes an ethically defensible notion of futility. [ABSTRACT FROM AUTHOR]

Futility monitoring of randomized clinical trials is becoming widely used. In this paper we discuss several concerns associated with aggressive monitoring for lack of activity in studies comparing experimental and control treatment arms: (1) stopping for futility when the experimental arm is doing better than the control arm, (2) conditional power not being low at the time of stopping, (3) potential loss of power to detect clinically interesting differences that are smaller than the design alternative, and (4) sensitivity of the power to the departure from the proportional hazards assumption. Our investigation suggests that aggressive futility rules do not generally reduce power (relative to less aggressive rules) under incorrect design assumptions such as overstatement of the target treatment effect or mild violations of the proportional hazards assumption. On the other hand, aggressive monitoring rules may result in an early termination for futility when the experimental arm is doing better than the control arm (in some cases nontrivially better, especially when trials are designed for unrealistically large effects). Thus, aggressive monitoring rules may fail to provide sufficiently convincing evidence to influence clinical practice or to establish a standard of treatment. [Copyright &y& Elsevier]

This paper offers a narrative approach to understanding the process of clinical reasoning in complex cases involving medical uncertainty, moral ambiguity, and futility. We describe a clinical encounter in which the pediatric health care team experienced a great deal of conflict and distrust as a result of an ineffective process of interpretation and communication. We propose a systematic method for analyzing the technical, ethical, behavioral, and existential dimensions of the clinical reasoning process, and introduce the Clinical Reasoning Discussion Tool—a dialogical and interpretive device aimed at improving communication, understanding, empathy, and moral deliberation in the clinical setting. [ABSTRACT FROM AUTHOR]

The treatment for patients with alcoholic hepatitis (AH) who have a discriminant function (DF) score greater than 32 has been steroids. A prior study reported that mortality approaches 100% when the DF score is greater than 54, despite the use of prednisolone. Our aim was to determine if a DF score greater than 54 is associated with high mortality despite steroids. We conducted a retrospective study of 531 first-time inpatient encounters of AH. We compared 30-day mortality between patients with DF 54 or less to those greater than 54 treated with steroids, as well as a matched group not treated with steroids. A total of 531 inpatients diagnosed with AH were identified, of which 124 had a DF greater than 32 and 52 were treated with steroids. Among patients treated with steroids, 30-day mortality for patients with DF greater than 54 (n = 27) and 54 or below (n = 25) was 22% and 12%, respectively (p = 0.47). Among patients with DF greater than 54, the 30-day mortality for those who did (n = 27) and did not (n = 29) receive steroids was 22% and 24%, respectively (p = 0.87). In our study population, steroids were not futile in patients with a DF score of greater than 54. [ABSTRACT FROM AUTHOR]