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Shaffer, BrianW. The blinding torch: Modern British fiction and the discourse of civilization. Amherst: University of Massachusetts Press, 1993.
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Shaffer, Brian W. The blinding torch: Modern British fiction and the discourse of civilization. Amherst: University of Massachusetts Press, 1993.
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Degenhardt, Sven. Computereinsatz bei blinden und sehbehinderten Schülern. Potsdam: Universität Potsdam, Institut für Sonderpädagogik, 1994.
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Pittioni, Richard. Über das Kupfererzbergbaugebiet Blindis-Tögisch bei St.Jakob i.Defr. Osttirol. Wien: Verlag der Österreichischen Akademie der Wissenschaften, 1986.
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Merkle, Harry. Die künstlichen Blinden: Blinde Figuren in Texten sehender Autoren. Würzburg: Königshausen & Neumann, 2000.
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Staupendahl, Frauke. Musik mit Blinden: Eine Einführung in die Musik- und Instrumentalpädagogik. Münster: Waxmann, 1998.
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Wurzel, Bettina. Sportunterricht mit Nichtbehinderten und Behinderten: Untersucht am Beispiel von Sehenden und Blinden. Schorndorf: Hofmann, 1991.
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Wie ein dunkler Sprung durch eine helle Tasse: Rainer Maria Rilkes Poetik des Blinden : eine ukrainische Spur. Würzborg: Königshausen & Neumann, 2007.
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L, Emiliani P., and Commission of the European Communities. Committee on Medical and Public Health Research., eds. Development of electronic aids for the visually impaired: Proceedings of a Workshop on the Rehabilitation of the Visually Impaired, held at the Institute for Research on Electromagnetic Waves of the National Research Council, Florence, Italy. Dordrect: Nijhoff/Junk Publishers, 1986.
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Ghattas, Michael. Die Christologie Didymos' des Blinden von Alexandria in den Schriften von Tura: Zur Entwicklung der alexandrinischen Theologie des 4. Jahrhunderts. Münster: Lit, 2002.
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Harrison, Mark. Blinding. Oxford University Press, 2017. http://dx.doi.org/10.1093/med/9780198765875.003.0060.
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This chapter describes blinding as applied to Emergency Medicine, and in particular the Primary FRCEM examination. The chapter outlines the key details and methods involved with blinding trials. This chapter is laid out exactly following the RCEM syllabus, to allow easy reference and consolidation of learning.
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Catanzaro, Michael P. Internal Mammary Artery Ligation versus Sham Sternotomy for Angina Pectoris. Edited by Rachel J. Kwon. Oxford University Press, 2017. http://dx.doi.org/10.1093/med/9780199384075.003.0044.
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This chapter provides a summary of a landmark historical study in cardiac surgery related to internal mammary artery ligation versus sham sternotomy for angina pectoris. It describes the history of the procedure and a summary of the study including study design and results, and relates the study to a modern-day principle of evidence-based medicine: blinding and sham surgery. Whether or not sham surgery is ethical remains under debate. Proponents for sham surgery agree that it should be used only when a question cannot be answered adequately by other methods. Cobb and his colleagues were among the first to demonstrate the value of sham studies in addressing important clinical questions.
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Steinberg, Jonny. Policing During and After Apartheid. Oxford University Press, 2017. http://dx.doi.org/10.1093/oso/9780190676636.003.0005.
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This chapter addresses the question of historical continuity and change within the South African Police Service after the end of apartheid. The prevalent interest in continuity between apartheid and post-apartheid policing risks blinding scholarship to what has changed. At the heart of this change lies the relationship between policing and political order, between politics and state coercion. Whereas during apartheid the police was primarily driven by the fight against insurgency, the police in democratic South Africa is primarily tasked with managing the conflicts of the ruling ANC. This chapter argues that instruments, institutions and mentalities from the past survive insofar as they are useful to agents in the present.
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Wiffen, Philip, Marc Mitchell, Melanie Snelling, and Nicola Stoner. Clinical trials. Oxford University Press, 2012. http://dx.doi.org/10.1093/med/9780199603640.003.0005.
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Clinical trial regulations 108Licensing of a clinical trial 109Clinical trial development phases 110Trial design, randomization, and blinding 111European Clinical Trials Directive 112Clinical trials: hospital pharmacy guidance 114Ethical committees 116Clinical trials form a fundamental part in the research, development, and licensing of new medicines. Research of how the drug interacts in humans is essential to ensure safe and effective medicines are licensed as new treatments. It is an exciting and varied role at the cutting edge of modern research with trials ranging across all therapeutic specialities. Clinical Trial pharmacists are therefore required to have a broad clinical knowledge and a specialist knowledge of the regulations that clinical trials have to follow....
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Schug, Stephan. Epidural block and phantom limb pain. Edited by Paul Farquhar-Smith, Pierre Beaulieu, and Sian Jagger. Oxford University Press, 2018. http://dx.doi.org/10.1093/med/9780198834359.003.0053.
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The landmark paper discussed in this chapter, published by Bach et al. in 1988 is a Danish paper that describes a study where patients who were to undergo lower-limb amputation received either preventive, preoperative epidural analgesia for 72 hours before the amputation, or systemic analgesia. At 6 and 12 months post-operatively, all patients in the epidural group were pain free, while 38% and 27%, respectively, in the control group had phantom limb pain. The study has been criticized for a number of points including the pseudorandomization by year of birth, the lack of any blinding, and the small number of patients used in the study (only 25 patients overall).
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Elwood, Mark. Selection of subjects for study. Oxford University Press, 2017. http://dx.doi.org/10.1093/med/9780199682898.003.0005.
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This chapter discussed principles of subject selection and defines target, source, eligible, entrant and participant populations. Selection issues and selection bias may affect internal validity, external validity, and modify the hypothesis being tested. It shows methods to reduce selection biases and to define participation rate and response rate. Principles for the selection of the exposed or test group and the comparison groups are shown for all studies. In randomised trials, intention-to-treat analysis, contamination, blinding, data monitoring, stopping rules, the CONSORT format, and trial registration are discussed. For observational studies, it shows the purpose of control groups, issues of definition and choice of controls, institutional and community controls, and frequency and individual matching. Many examples are given.
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Clark, Heather L., and Eric Pearlman. Fungal eye infections. Edited by Christopher C. Kibbler, Richard Barton, Neil A. R. Gow, Susan Howell, Donna M. MacCallum, and Rohini J. Manuel. Oxford University Press, 2017. http://dx.doi.org/10.1093/med/9780198755388.003.0028.
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Mycotic keratitis is a fungal infection of the cornea that leads to severe, painful ulceration and loss of vision, and is a major cause of blindness worldwide, particularly in the developing world. Major risk factors for mycotic keratitis include ocular trauma and contact lens use. Both yeasts and moulds can cause mycotic keratitis, with the filamentous moulds of the Fusarium and Aspergillus genera the most common aetiological agents worldwide. Fungi, particularly Candida spp. yeasts, can also cause endophthalmitis—a painful, blinding infection of the posterior eye. Treatment of these infections is challenging owing to a limited arsenal of antifungal agents and highly variable susceptibility among causative fungi. Furthermore, associated inflammation contributes greatly to tissue damage and permanent blindness. Studies using experimental models of mycotic keratitis have revealed new targets for novel antifungal agents and anti-inflammatory therapies that have the potential to reduce the impact of these devastating infections.
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Joshi, Mahesh K., and J. R. Klein. Is Globalization Killing Local Business? Oxford University Press, 2018. http://dx.doi.org/10.1093/oso/9780198827481.003.0002.
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The fact that the influence of globalization has been driven by dramatic changes is not one of those “blinding flashes of the obvious” that seems to sneak up on us. It is very evident and even predictable. Advances in technology, markets, and environments were precursors to the big changes we are now talking about. Advances in technology have led to the current global grid driven by information. The primary mission of business is to provide solutions, and this technology explosion has provided opportunities and market applications for those solutions. Local businesses now have an opportunity to move beyond their restricted geography of the past into the global arena with the use of technology. A local store in a remote village in Kentucky has the same opportunity as a large store in London to access global customers. These could be exciting times for local businesses if they use technology to their advantage.
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Alden, Maureen. The Cyclops. Oxford University Press, 2017. http://dx.doi.org/10.1093/oso/9780199291069.003.0008.
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Odysseus’ blinding of the Cyclops by a combination of μῆτις and βίη continues the debate on the qualities needed for success initiated in the songs of Demodocus. The uncultivated Cyclopes reflect a reversed image of their relatives, the super-civilized Phaeacians. The mirror of the Cyclopeia simultaneously reflects the suitors (Model A) and Odysseus himself (Model B). In Model A, the suitors parallel the Cyclops as Odysseus’ adversary. No One is the false name by which Odysseus tricks the Cyclops: the suitors fear no one. Their consumption of Odysseus’ flocks and herds corresponds to the Cyclops’ consumption of Odysseus’ companions. Both they and the Cyclops are killed while under the influence of wine. In Model B, Odysseus returns, like the Cyclops, to find intruders consuming his resources. Odysseus confronts the suitors from the doorway of his hall in a near theophany parodied by the blinded Cyclops in his cave doorway.
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Strand, Vibeke, Jeremy Sokolove, and Alvina D. Chu. Design of clinical trials in rheumatology. Oxford University Press, 2013. http://dx.doi.org/10.1093/med/9780199642489.003.0030.
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Development of new therapies for rheumatic diseases requires a series of randomized controlled trials (RCTs) progressing from phase 1, 'first-in-human' to generate initial safety, pharmacokinetic (PK) and pharmacodynamic (PD) data; to phase 2, proof of concept for efficacy with safety and PK/PD data; and phase 3, designed to demonstrate definitive efficacy and safety to support regulatory approval. Important aspects of RCT designs include sample size estimations, treatment allocation, rescue, blinding, and statistical analyses of prespecified endpoints to preserve trial integrity. Over the past 15 years, significant progress has been made in the design of RCTs in rheumatoid arthritis (RA). Similarly, development and validation of composite outcome measures in psoriatic arthritis, ankylosing spondylitis, gout, and osteoarthritis have furthered trial design and treatment approvals. RCTs in systemic lupus erythematosus and other multisystem, heterogeneous diseases pose more challenges. Trial design will continue to evolve as promising therapies are introduced into the clinic.
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Strand, Vibeke, Jeremy Sokolove, and Alvina D. Chu. Design of clinical trials in rheumatology. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780199642489.003.0030_update_001.
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Development of new therapies for rheumatic diseases requires a series of randomized controlled trials (RCTs) progressing from phase 1, ’first-in-human’ to generate initial safety, pharmacokinetic (PK) and pharmacodynamic (PD) data; to phase 2, proof of concept for efficacy with safety and PK/PD data; and phase 3, designed to demonstrate definitive efficacy and safety to support regulatory approval. Important aspects of RCT designs include sample size estimations, treatment allocation, rescue, blinding, and statistical analyses of prespecified endpoints to preserve trial integrity. Over the past 15 years, significant progress has been made in the design of RCTs in rheumatoid arthritis (RA). Similarly, development and validation of composite outcome measures in psoriatic arthritis, ankylosing spondylitis, gout, and osteoarthritis have furthered trial design and treatment approvals. RCTs in systemic lupus erythematosus and other multisystem, heterogeneous diseases pose more challenges. Trial design will continue to evolve as promising therapies are introduced into the clinic.
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Strand, Vibeke, Jeremy Sokolove, and Alvina D. Chu. Design of clinical trials in rheumatology. Oxford University Press, 2018. http://dx.doi.org/10.1093/med/9780199642489.003.0030_update_002.
Full textAbstract:
Development of new therapies for rheumatic diseases requires a series of randomized controlled trials (RCTs) progressing from phase 1, ’first-in-human’ to generate initial safety, pharmacokinetic (PK) and pharmacodynamic (PD) data; to phase 2, proof of concept for efficacy with safety and PK/PD data; and phase 3, designed to demonstrate definitive efficacy and safety to support regulatory approval. Important aspects of RCT designs include sample size estimations, treatment allocation, rescue, blinding, and statistical analyses of prespecified endpoints to preserve trial integrity. Over the past 15 years, significant progress has been made in the design of RCTs in rheumatoid arthritis (RA). Similarly, development and validation of composite outcome measures in psoriatic arthritis, ankylosing spondylitis, gout, and osteoarthritis have furthered trial design and treatment approvals. RCTs in systemic lupus erythematosus and other multisystem, heterogeneous diseases pose more challenges. Trial design will continue to evolve as promising therapies are introduced into the clinic.
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Burns, Tom, and Mike Firn. Research and development. Edited by Tom Burns and Mike Firn. Oxford University Press, 2017. http://dx.doi.org/10.1093/med/9780198754237.003.0029.
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This chapter covers the spectrum of routine monitoring, audit, service evaluation, and formal research. Routine monitoring is an essential task for all mental health professionals, and techniques to make it more palatable are explored, including using routine data for clinical supervision and monitoring team targets. Regular audit is described as an essential tool for logical service development and quality improvement. In the discussion of research, the importance of choosing the correct methodology and of paying attention to detail are stressed. In community psychiatry, sampling bias, regression to the mean, and the Hawthorne effect pose important risks. The hierarchy of research methods is outlined with randomized controlled trials (RCTs) at the top, preferably with either single- or double-blinding. Careful statistics and systematic reviews support evidence-based practice. In addition to experimental quantitative trials, there is a place for cohort and case control trials, as well as for qualitative trials to generate hypotheses.
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Farrar, John T. Understanding clinical trials in palliative care research. Oxford University Press, 2015. http://dx.doi.org/10.1093/med/9780199656097.003.0193.
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Advances in basic science, translational, and clinical research have led to rapid improvements in our understanding of many disease processes. The randomized clinical trial (RCT) has played an important role in validating the benefits and harms of therapies thought to be potentially useful based on scientific theory or clinical observation, and has become the ‘gold standard’ for the demonstration of efficacy. As in all clinical study designs, the RCT has strengths and weaknesses that must be understood to appropriately interpret the study results. While randomization of the intended study population is the primary strength of such trials, choice of the study population, control condition, outcome measures, analysis procedure, and procedures for blinding the study participants can all affect the results. Understanding the requirements of a valid RCT and what can potentially go wrong will improve the conduct of palliative care research and the usefulness of published information in the care of patients.
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Ray, Sumantra (Shumone), Sue Fitzpatrick, Rajna Golubic, Susan Fisher, and Sarah Gibbings, eds. Clinical trial design. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780199608478.003.0014.
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This chapter outlines the various study designs and their uses. The phases of drug development are described and the appropriate study design employed at each phase of development is identified Elimination of bias is critical to the study design and methods of eliminating bias are discussed, defining the population, randomisation and blinding. A summary of the elements to be considered when designing a study are presented including the types of control, placebo or active, and their uses, Non comparative and comparative designs are presented. In the comparative design both within and between patient designs are discussed including crossover, parallel, sequential, factorial and left right comparisons. Patient outcomes measures as well as efficacy measurement are required for new treatments. There is a brief review of pharmaeconomic study designs. Other types of study design, dose escalation and dose response studies are also discussed. As well as reducing bias in studies another critical element is the recording of the primary assessment methods. The choice of methods will affect other aspects of the study such as the statistical considerations. The methodology must be standardised and validated.
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Kulkarni, Kunal, James Harrison, Mohamed Baguneid, and Bernard Prendergast, eds. The history of evidence-based medicine. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780198729426.003.0001.
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The pursuit of tests for therapeutic interventions has been a characteristic of Western medicine since ancient times. Historical accounts of the clinical trial are usually expressed through the lens of presentism: how the various components of the first modern randomized controlled trial-the comparison, blinding, and randomization-culminated in Austin Bradford Hill’s 1946 trial of streptomycin for tuberculosis. The factual context of the development of the randomized controlled trial is important if only to emphasize the historicity of contemporary research methodology. However, the adoption of the various components of the trial at any one time has as much to do with changing the socio-political and ethical contexts as the ‘objective’ scientific standards of evidence. Evidence is not just scientific data floating in some ethereal medium, but is also linked to facts and beliefs of the various members of diverse medical communities who interpret evidence and deploy it to legitimize various strategies. This introductory chapter aims to present the background and context through which evidence-based medicine has emerged.
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Ray, Sumantra (Shumone), Sue Fitzpatrick, Rajna Golubic, Susan Fisher, and Sarah Gibbings, eds. Clinical trial supplies: investigational medicinal products (IMPs). Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780199608478.003.0017.
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This chapter describes the procedures and records associated with accountability of investigational and non-investigational medicinal products (IMP and NIMP) used in clinical trials, to show that the drug has been labelled according to the regulations, stored in conditions to keep it stable, prepared and administered to the correct subjects in accordance with the protocol, has been fully accounted for and destroyed if unused. Manufacture of IMP is discussed together with methods of blinding. The role of the Qualified person (QP) is reviewed. The need for study drug accountability is discussed in context with the regulatory requirements (Clinical Trial Directive 2001/20/EC and in particular, GMP Directive 2003/94/EC Annex 13). The chapter explains what needs to be accounted for and describes the types of records including: labelling records, delivery and transportation, receipt, storage, preparation, dispensing and administration, unblinding records, reconciliation, returns and destruction. Discussions are included on protocol compliance, management of excursions resulting from incorrect storage conditions, management of dosing errors and documentation errors, expiry date re-labelling, drug recall and re-supply. Sections are included on considerations for non-commercial studies, GMP requirements for UK Phase I clinics and sites requiring a MIA (IMP) license.
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Howell, Simon J. Clinical trial designs in anaesthesia. Edited by Jonathan G. Hardman. Oxford University Press, 2017. http://dx.doi.org/10.1093/med/9780199642045.003.0030.
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A clinical trial is a research study that assigns people or groups to different interventions and compares the impact of these on health outcomes. This chapter examines the design and delivery of clinical trials in anaesthesia and perioperative medicine covering the issues outlined below. The features of a high-quality clinical trial include well-defined inclusion and exclusion criteria, a control group, randomization, and blinding. Outcome measures may be broadly divided into counting the number of people who experience an outcome and taking measurements on people. The outcome measures selected for a clinical trial reflect the purpose of the study and may include ‘true’ clinical measures such as major postoperative complications or surrogate measures such as the results of a biochemical test. Outcome measures may be combined in a composite outcome. Assessment of health-related quality of life using a tool such as the SF-36 questionnaire is an important aspect of many clinical trials in its own right and also informs the economic analyses that may be embedded in a trial. Determining the number for recruits needed for a clinical trial requires both clinical and statistical insight and judgement. The analysis of a clinical trial requires a similarly sophisticated approach that takes into account the objectives of the study and balances the need for appropriate subgroup analyses with the risk of false-positive results. The safe and effective management of a clinical trial requires rigorous organizational discipline and an understanding of the ethical and regulatory structures that govern clinical research.
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Yurdakul, Sebahattin, Emire Seyahi, and Hasan Yazici. Behçet’s syndrome. Oxford University Press, 2013. http://dx.doi.org/10.1093/med/9780199642489.003.0135.
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Behçet's syndrome is a systemic inflammatory panvasculitis (affecting all sizes of vessels) of unknown aetiology. It is in vogue to include it among the systemic autoinflammatory conditions. Behçet's syndrome is more frequent along the ancient 'Silk Route' across Asia than it is in Western countries. The usual onset is the second or third decade, equally affecting either gender. However, young patients and male patients have more severe disease. Almost all patients have recurrent oral ulceration. Scar-forming genital ulcers, a variety of skin lesions including acneiform, erythema nodosum-like lesions, arthritis, potentially blinding panuveitis, thrombophlebitis, gastrointestinal disease, central nervous system (CNS) involvement, and life-threatening bleeding pulmonary artery aneurysms are seen. The pathergy phenomenon is a heightened tissue inflammatory response. The strongest genetic association is with HLA B51. There are immunological aberrations but not prominent enough to call it an autoimmune disease. Similarly, Behçet's syndrome does not fit easily into the broad concept of autoinflammatory diseases. The histopathology is also non-specific and the diagnosis is mainly clinical. Differentiation from Crohn's disease is very difficult. In more than one-half of the patients the disease burns out in time, thus only symptomatic therapy is indicated in some patients. However, eye involvement, pulmonary vascular disease, thrombophilic complications, CNS involvement, and gastrointestinal disease need prompt recognition and treatment. Brief courses of glucocorticosteroids along with immunosuppressives including the newer biologicals, interferon, and colchicine are commonly used. However, controlled clinical trials are not available for some of these medications especially when thrombophilia, CNS, and gastrointestinal disease are present.
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Verschuur, Gerrit L. Impact! Oxford University Press, 1996. http://dx.doi.org/10.1093/oso/9780195101058.001.0001.
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Most scientists now agree that some sixty-five million years ago, an immense comet slammed into the Yucatan, detonating a blast twenty million times more powerful than the largest hydrogen bomb, punching a hole ten miles deep in the earth. Trillions of tons of rock were vaporized and launched into the atmosphere. For a thousand miles in all directions, vegetation burst into flames. There were tremendous blast waves, searing winds, showers of molten matter from the sky, earthquakes, and a terrible darkness that cut out sunlight for a year, enveloping the planet in freezing cold. Thousands of species of plants and animals were obliterated, including the dinosaurs, some of which may have become extinct in a matter of hours. In Impact, Gerrit L. Verschuur offers an eye-opening look at such catastrophic collisions with our planet. Perhaps more important, he paints an unsettling portrait of the possibility of new collisions with earth, exploring potential threats to our planet and describing what scientists are doing right now to prepare for this awful possibility. Every day something from space hits our planet, Verschuur reveals. In fact, about 10,000 tons of space debris fall to earth every year, mostly in meteoric form. The author recounts spectacular recent sightings, such as over Allende, Mexico, in 1969, when a fireball showered the region with four tons of fragments, and the twenty-six pound meteor that went through the trunk of a red Chevy Malibu in Peekskill, New York, in 1992 (the meteor was subsequently sold for $69,000 and the car itself fetched $10,000). But meteors are not the greatest threat to life on earth, the author points out. The major threats are asteroids and comets. The reader discovers that astronomers have located some 350 NEAs ("Near Earth Asteroids"), objects whose orbits cross the orbit of the earth, the largest of which are 1627 Ivar (6 kilometers wide) and 1580 Betula (8 kilometers). Indeed, we learn that in 1989, a bus-sized asteroid called Asclepius missed our planet by 650,000 kilometers (a mere six hours), and that in 1994 a sixty-foot object passed within 180,000 kilometers, half the distance to the moon. Comets, of course, are even more deadly. Verschuur provides a gripping description of the small comet that exploded in the atmosphere above the Tunguska River valley in Siberia, in 1908, in a blinding flash visible for several thousand miles (every tree within sixty miles of ground zero was flattened). He discusses Comet Swift-Tuttle--"the most dangerous object in the solar system"--a comet far larger than the one that killed off the dinosaurs, due to pass through earth's orbit in the year 2126. And he recounts the collision of Comet Shoemaker-Levy 9 with Jupiter in 1994, as some twenty cometary fragments struck the giant planet over the course of several days, casting titanic plumes out into space (when Fragment G hit, it outshone the planet on the infrared band, and left a dark area at the impact site larger than the Great Red Spot). In addition, the author describes the efforts of Spacewatch and other groups to locate NEAs, and evaluates the idea that comet and asteroid impacts have been an underrated factor in the evolution of life on earth. Astronomer Herbert Howe observed in 1897: "While there are not definite data to reason from, it is believed that an encounter with the nucleus of one of the largest comets is not to be desired." As Verschuur shows in Impact, we now have substantial data with which to support Howe's tongue-in-cheek remark. Whether discussing monumental tsunamis or the innumerable comets in the Solar System, this book will enthrall anyone curious about outer space, remarkable natural phenomenon, or the future of the planet earth.