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PubMedDate not supplied

Acupuncture.

OBJECTIVE: The objective of this NIH Consensus Statement is to inform the biomedical research and clinical practice communities of the results of the NIH Consensus Development Conference on Acupuncture. The statement provides state-of-the-art information regarding the appropriate use of acupuncture, and presents the conclusions and recommendations of the consensus panel regarding these issues. In addition, the statement identifies those areas of study that deserve further investigation. Upon completion, the reader should possess a clear working clinical knowledge of the state-of-the-art regarding this topic. The target audience of physicians for this statement includes, but is not limited to, family practitioners, medical acupuncturists, psychiatrists, and specialists in pain medicine. PARTICIPANTS: A non-Federal, nonadvocate, 12-member panel representing the fields of acupuncture, pain, psychology, psychiatry, physical medicine and rehabilitation, drug abuse, family practice, internal medicine, health policy, epidemiology, statistics, physiology, biophysics, and the public. In addition, 25 experts from these same fields presented data to the panel and a conference audience of 1,200. EVIDENCE: The literature was searched through Medline, and an extensive bibliography of references was provided to the panel and the conference audience. Experts prepared abstracts with relevant citations from the literature. Scientific evidence was given precedence over clinical anecdotal experience. CONSENSUS PROCESS: The panel, answering predefined questions, developed their conclusions based on the scientific evidence presented in open forum and the scientific literature. The panel composed a draft statement, which was read in its entirety and circulated to the experts and the audience for comment. Thereafter, the panel resolved conflicting recommendations and released a revised statement at the end of the conference. The panel finalized the revisions within a few weeks after the conference. The draft statement was made available on the World Wide Web immediately following its release at the conference and was updated with the panel's final revisions. CONCLUSIONS: Acupuncture as a therapeutic intervention is widely practiced in the United States. While there have been many studies of its potential usefulness, many of these studies provide equivocal results because of design, sample size, and other factors. The issue is further complicated by inherent difficulties in the use of appropriate controls, such as placebos and sham acupuncture groups. However, promising results have emerged, for example, showing efficacy of acupuncture in adult postoperative and chemotherapy nausea and vomiting and in postoperative dental pain. There are other situations such as addiction, stroke rehabilitation, headache, menstrual cramps, tennis elbow, fibromyalgia, myofascial pain, osteoarthritis, low back pain, carpal tunnel syndrome, and asthma, in which acupuncture may be useful as an adjunct treatment or an acceptable alternative or be included in a comprehensive management program. Further research is likely to uncover additional areas where acupuncture interventions will be useful.

Acupuncture Analgesia↗
PubMed2005

National Institutes of Health Consensus Development Conference Statement on Celiac Disease, June 28-30, 2004.

NIH consensus and state-of-the-science statements are prepared by independent panels of health professionals and public representatives on the basis of (1) the results of a systematic literature review prepared under contract with the Agency for Healthcare Research and Quality (AHRQ); (2) presentations by investigators working in areas relevant to the conference questions during a 2-day public session; (3) questions and statements from conference attendees during open discussion periods that are part of the public session; and (4) closed deliberations by the panel during the remainder of the second day and morning of the third. This statement is an independent report of the panel and is not a policy statement of the NIH or the Federal Government. The statement reflects the panel's assessment of medical knowledge available at the time the statement was written. Thus, it provides a "snapshot in time" of the state of knowledge on the conference topic. When reading the statement, keep in mind that new knowledge is inevitably accumulating through medical research.

Biomedical Research↗
PubMed1994

National Institutes of Health Consensus Development Conference Statement. Ovarian cancer: screening, treatment, and follow-up.

The National Institutes of Health Consensus Development Conference on Ovarian Cancer-Screening, Treatment, and Follow-up brought together epidemiologists; obstetrician/gynecologists; gynecologic, medical, and radiation oncologists; and the public to address the following questions: (1) What is the current status of screening and prevention in ovarian cancer? (2) What is the appropriate management of early-stage ovarian cancer? (3) What is the appropriate management of advanced epithelial ovarian cancer? (4) What is the appropriate follow-up after primary therapy? and (5) What are the directions for future research? The consensus panel concluded that there is no evidence available as yet that the current screening modalities of CA 125 and transvaginal ultrasonography can be effectively used for widespread screening to reduce mortality from ovarian cancer nor that their use will result in decreased rather than increased morbidity and mortality. They recommended that further prospective research be done to evaluate this very important issue. Women with stage IA grade 1 and most IB grade 1 ovarian cancer do not require postoperative adjuvant therapy. Many remaining stage I patients do require chemotherapy. Subsets of stage I must be fully defined and ideal treatment must be determined. Women with stages II, III, and IV epithelial ovarian cancer (other than low malignant potential tumors) should receive postoperative chemotherapy. Physicians should be encouraged to discuss clinical trial participation with women, and women should be encouraged to participate. All women should have access to accurate and complete information regarding ovarian cancer. Furthermore, there must be no barriers to women's access to qualified specialists, optimal therapy, and protocols. The full text of the consensus panel's statement follows.

Combined Modality Therapy↗
PubMed2001

[Radiation therapy after mastectomy--interdisciplinary consensus puts and end to a controversy. German Society of Senology].

BACKGROUND: Recent publications of the Danish Breast Cancer Cooperative Group together with data from the British Columbia Trial have stirred major discussions concerning the role of radiation therapy after mastectomy. Different treatment approaches are to be found even within the same cancer center. The German Society of Senology, a cooperative group of all medical disciplines involved in the treatment of breast cancer, has therefore worked out a consensus statement. MATERIAL AND METHOD: The recently published literature and experts opinions, in particular randomized studies since 1997, meta-analyses from the Early Breast Cancer Trialists' Collaborative Group, epidemiological investigations with regard to the time course of distant metastases in breast cancer as well as the current consensus of the American Society for Therapeutic Radiology and Oncology served as the basis for discussion and consulting. RESULTS OF THE CONSENSUS: (1) An optimally performed mastectomy is a major prerequisite for tumor cure. Radical (R0) resection of the tumor as well as dissection of at least 10 lymph nodes from the axillary level I and II should be accomplished. If axillary lymph nodes are involved, the surgical removal of these lymph nodes is not only of diagnostic, but also of therapeutic value, as it reduces the risk for locoregional relapses. (2) Most probably, locoregional relapses do not only indicate, but are also a source for distant metastases. (3) Radiation therapy of the chest wall and the regional lymph nodes increases the overall survival in risk patients and reduces the risk of locoregional relapses. Moreover, radiation therapy improves the prognosis in case of residual tumor or an incomplete axillary dissection. Unequivocal and reasonable indications for radiation therapy after mastectomy include T3/T4-carcinoma, T2-carcinoma > 3 cm, multicentric tumor growth, lymphangiosis carcinomatosa or vessel involvement, involvement of the pectoralis fascia or a safety margin < 5 mm, R1- or R2 resection and more than 3 axillary lymph node metastases. Further reasonable indications, albeit not yet evaluated in clinical trials, include multifocality, extensive intraductal component, negative hormone receptor status, G3-differentiation grade, diffuse micro-calcifications, 1 to 3 axillary lymph node metastases, multiple, non-complete biopsies and age < 35 years. (4) An endocrine therapy with tamoxifen concurrent to radiation therapy is also reasonable--despite some contradictory in-vitro data--as it enhances the apoptotic cell death. The CMF-regimen is usually performed as sandwich procedure, but can also be applied concurrently to radiation therapy, if indicated. Conversely, an anthracycline-containing chemotherapy should be finished prior to postoperative radiation therapy. CONCLUSIONS: Adjuvant radiation therapy after mastectomy improves the 10-year-survival probability up to 10%, at least for risk patients. The hypotheses of Halsted and Fisher do not exclude each other. There are patients, in which the one, and there are patients, in which the other hypothesis applies.

Breast Neoplasms↗
PubMed2001

Report of the NASPE policy conference on arrhythmias and the athlete.

INTRODUCTION: This consensus statement summarizes the proceedings of The Expert Consensus Conference on Arrhythmias in the Athlete of the North American Society of Pacing and Electrophysiology (NASPE) on detecting, evaluating, and treating athletes with cardiovascular disorders that predispose to cardiac arrhythmias. METHODS AND RESULTS: The participants in the open policy conference were selected by the codirectors (Drs. Estes and Olshansky) based on expertise and contributions to the literature. All participants provided a referenced summary of their presentation. The writing group used the information from all published scientific studies, clinical trials, registries, clinical experience, and expert opinion to make recommendations regarding screening, evaluation, management, eligibility for competition, and a range of other medical, social, and legal issues regarding the recreational and competitive athlete. The codirectors of the symposium synthesized the participants' reports for this and made revisions according to suggestions of all members of the writing committee. The manuscript was reviewed by four independent reviewers assigned by the NASPE Committee for the Development of Position Statements and NASPE Board of Trustees. CONCLUSION: Despite considerable advances in knowledge regarding the diagnosis, therapy, and mechanisms of arrhythmias in the athlete, much remains unknown. Continued basic, clinical, and epidemiologic research is needed. Current screening techniques to detect athletes lack sensitivity and specificity. Evaluation of standardized screening programs with tracking of long-term outcomes is needed. Officials from athletic, academic, medical, and legal institutions need to form strategic partnerships to develop policy related to assessment of risk and assumption of responsibility for athletic activities.

Arrhythmias, Cardiac↗
PubMedDate not supplied

Diagnosis and treatment of attention deficit hyperactivity disorder (ADHD).

OBJECTIVE: The objective of this NIH Consensus Statement is to inform the biomedical research and clinical practice communities of the results of the NIH Consensus Development Conference on Diagnosis and Treatment of Attention Deficit Hyperactivity Disorder (ADHD). The statement provides state-of-the-art information regarding effective treatments for ADHD and presents the conclusions and recommendations of the consensus panel regarding these issues. In addition, the statement identifies those areas of study that deserve further investigation. Upon completion of this educational activity, the reader should possess a clear working clinical knowledge of the state of the art regarding this topic. The target audience of clinicians for this statement includes, but is not limited to, psychiatrists, family practitioners, pediatricians, internists, neurologists psychologists, and behavioral medicine specialists. PARTICIPANTS: Participants were a non-Federal, nonadvocate, 13-member panel representing the fields of psychology, psychiatry, neurology, pediatrics, epidemiology, biostatistics, education and the public. In addition, 31 experts from these same fields presented data to the panel and a conference audience of 1215. EVIDENCE: The literature was searched through Medline and an extensive bibliography of references was provided to the panel and the conference audience. Experts prepared abstracts with relevant citations from the literature. Scientific evidence was given precedence over clinical anecdotal experience. CONSENSUS PROCESS: The panel, answering predefined questions, developed their conclusions based on the scientific evidence presented in open forum and the scientific literature. The panel composed a draft statement that was read in its entirety and circulated to the experts and the audience for comment. Thereafter, the panel resolved conflicting recommendations and released a revised statement at the end of the conference. The panel finalized the revisions within a few weeks after the conference. The draft statement was made available on the World Wide Web immediately following its release at the conference and was updated with the panel's final revisions. CONCLUSIONS: Attention deficit hyperactivity disorder or ADHD is a commonly diagnosed behavioral disorder of childhood that represents a costly major public health problem. Children with ADHD have pronounced impairments and can experience long-term adverse effects on academic performance, vocational success, and social-emotional development which have a profound impact on individuals, families, schools, and society. Despite progress in the assessment, diagnosis, and treatment of ADHD, this disorder and its treatment have remained controversial, especially the use of psychostimulants for both short and long-term treatment. Although an independent diagnostic test for ADHD does not exist, there is evidence supporting the validity of the disorder. Further research is needed on the dimensional aspects of ADHD, as well as the comorbid (coexisting) conditions present in both childhood and adult forms. Studies, (primarily short term, approximately three months) including randomized clinical trials, have established the efficacy of stimulants and psychosocial treatments for alleviating the symptoms of ADHD and associated aggressiveness and have indicated that stimulants are more effective than psychosocial therapies in treating these symptoms. Because of the lack of consistent improvement beyond the core symptoms and the paucity of long-term studies (beyond 14 months), there is a need for longer term studies with drugs and behavioral modalities and their combination. Although trials are underway, conclusive recommendations concerning treatment for the long term cannot be made presently. There are wide variations in the use of psychostimulants across communities and physicians, suggesting no consensus regarding which ADHD patients should be treated with psychostimulants. (ABSTRACT

Adult↗
PubMed2003

Methodological issues and controversies in clinical trials with child and adolescent patients with bipolar disorder: report of a consensus conference.

OBJECTIVE: To achieve consensus among researchers, pharmaceutical industry representatives, federal regulatory agency staff, and family advocates on a template for clinical trials of acute mania/bipolar disorder in children and adolescents. METHOD: The American Academy of Child and Adolescent Psychiatry, in collaboration with Best Practice, convened a group of experts from the key stakeholder communities (including adult psychiatrists with expertise in bipolar disorder) and assigned them to workgroups to examine core methodological issues surrounding the design of clinical trials and, ultimately, to generate a consensus statement encompassing: (1) inclusion/exclusion criteria, (2) investigator training needs and site selection, (3) assessment and outcome measures, (4) protocol design and ethical issues unique to trials involving children/adolescents, and (5) regulatory agency perspectives on these deliberations. RESULTS: Conference participants reached agreement on 18 broad methodological questions. Key points of consensus were to assign priority to placebo-controlled studies of acute manic episodes in children and adolescents aged 10-17 years, who may or may not be hospitalized, and who may or may not suffer from common comorbid psychiatric disorders; to require that specialist diagnostic "gatekeepers" screen youths' eligibility to participate in trials; to monitor interviewer and rater competency over the course of the trial using agreed upon standards; and to develop new tools for assessment, including scales to measure aggression/rage and cognitive function, while using the best available instruments (e.g., Young Mania Rating Scale) in the interim. CONCLUSIONS: Methodologically rigorous, large-scale clinical trials of treatment of acute mania are urgently needed to provide information regarding the safety and efficacy, in youth, of diverse agents with potential mood-stabilizing properties.

Adolescent↗
PubMed2006

Contrast-Induced Nephropathy (CIN) Consensus Working Panel: executive summary.

With the advances made in radiology and cardiology, greater numbers of patients are expected to undergo exposure to iodinated contrast media in the years to come. Contrast-induced nephropathy (CIN) accounts for a significant number of cases of hospital-acquired renal failure, with adverse effects on prognosis and healthcare costs. The CIN Consensus Working Panel is an international multidisciplinary group convened to address the challenges of CIN. The group reviewed 865 published papers, chosen for potential relevance from a comprehensive literature search that identified over 4000 references. The results were used to compile reviews covering the epidemiology and pathogenesis of CIN, baseline renal function measurement, risk assessment, identification of high-risk patients, contrast medium use, and preventive strategies. In this executive summary, consensus statements and an algorithm for the risk stratification and management of CIN are presented.

Contrast Media↗
PubMedDate not supplied

Rehabilitation of persons with traumatic brain injury.

OBJECTIVE: The objective of this NIH Consensus Statement is to inform the biomedical research and clinical practice communities of the results of the NIH Consensus Development Conference on Rehabilitation of Persons with Traumatic Brain Injury. The statement provides state-of-the-art information regarding effective rehabilitation measures for persons who have suffered a traumatic brain injury (TBI) and presents the conclusions and recommendations of the consensus panel regarding these issues. In addition, the statement identifies those areas that deserve further investigation. Upon completion of this educational activity, the reader should possess a clear working clinical knowledge of the state of the art regarding this topic. The target audience for this statement includes, but is not limited to, pediatricians, family practitioners, internists, neurologists, physiatrists, psychologists, and behavioral medicine specialists. PARTICIPANTS: Participants were a non-Federal, nonadvocate, 16-member panel representing the fields of neuropsychology, neurology, psychiatry, behavioral medicine, family medicine, pediatrics, physical medicine and rehabilitation, speech and hearing, occupational therapy, nursing, epidemiology, biostatistics and the public. In addition, 23 experts from these same fields presented data to the panel and a conference audience of 883. EVIDENCE: The literature was searched through Medline and an extensive bibliography of references was provided to the panel and the conference audience. Experts prepared abstracts with relevant citations from the literature. A compendium of evidence was prepared by the panel which included a contribution from a patient with TBI, a report from an Evidence Based Practice Center of the Agency for Health Care Policy and Research, and a report from the National Center for Injury Prevention and Control at the Centers for Disease Control and Prevention. Scientific evidence was given precedence over clinical anecdotal experience. CONSENSUS PROCESS: The panel, answering predefined questions, developed their conclusions based on the scientific evidence presented in open forum and the scientific literature. The panel composed a draft statement that was read in its entirety and circulated to the experts and the audience for comment. Thereafter, the panel resolved conflicting recommendations and released a revised statement at the end of the conference. The panel finalized the revisions within a few weeks after the conference. The draft statement was made available on the World Wide Web immediately following its release at the conference and was updated with the panel's final revisions. CONCLUSIONS: Traumatic Brain Injury (TBI) results principally from vehicular incidents, falls, acts of violence, and sports injuries, and is more than twice as likely in males as in females. The estimated incidence rate is 100 per 100,000 persons with 52,000 annual deaths. The highest incidence is among persons 15 to 24 years of age and 75 years and older, with an additional less striking peak in incidence in children ages 5 and younger. Since TBI may result in lifelong impairment of an individual's physical, cognitive, and psychosocial functioning and prevalence is estimated to be 2.5 million to 6.5 million individuals, TBI is a disorder of major public health significance. Furthermore, mild TBI is significantly under diagnosed and the likely societal burden therefore even greater. Given the large toll of TBI and absence of a cure, prevention is of paramount importance. However, the focus of this conference was the evaluation of rehabilitative measures available for the cognitive and behavioral consequences of TBI. Although studies are relatively limited, available evidence supports the use of certain cognitive and behavioral rehabilitation strategies for individuals with TBI. This research needs to be replicated in larger, more definitive clinical trials. (ABSTRACT TRUNCATED)

Adolescent↗
PubMed2006

Proposed quality measures for palliative care in the critically ill: a consensus from the Robert Wood Johnson Foundation Critical Care Workgroup.

For critically ill patients and their loved ones, high-quality health care includes the provision of excellent palliative care. To achieve this goal, the healthcare system needs to identify, measure, and report specific targets for quality palliative care for critically ill or injured patients. Our objective was to use a consensus process to develop a preliminary set of quality measures to assess palliative care in the critically ill. We built on earlier and ongoing efforts of the Robert Wood Johnson Foundation Critical Care End-of-Life Peer Workgroup to propose specific measures of the structure and process of palliative care. We used an informal iterative consensus process to identify and refine a set of candidate quality measures. These candidate measures were developed by reviewing previous literature reviews, supplementing the evidence base with recently published systematic reviews and consensus statements, identifying existing indicators and measures, and adapting indicators from related fields for our objective. Among our primary sources, we identified existing measures from the Voluntary Hospital Association's Transformation of the ICU program and a government-sponsored systematic review performed by RAND Health to identify palliative care quality measures for cancer care. Our consensus group proposes 18 quality measures to assess the quality of palliative care for the critically ill and injured. A total of 14 of the proposed measures assess processes of care at the patient level, and four measures explore structural aspects of critical care delivery. Future research is needed to assess the relationship of these measures to desired health outcomes. Subsequent measure sets should also attempt to include outcome measures, such as patient or surrogate satisfaction, as the field develops the means to rigorously measure such outcomes. The proposed measures are intended to stimulate further discussion, testing, and refinement for quality of care measurement and enhancement.

Continuity of Patient Care↗
PubMed1989

Statement on outpatient percutaneous liver biopsy.

This document represents a consensus statement dealing with optimum patient care in a significant clinical area. The statement has been prepared by the Patient Care Committee of the American Gastroenterological Association with the advice of other experts and with peer review. As with all such guidelines, this should be interpreted in a nondogmatic manner, so as not to exclude other therapies or opinions in any particular situation. Based on present knowledge, limited at times, future modifications or other changes in this statement may be necessary.

Ambulatory Care↗
PubMed2006

Diabetes mellitus screening in pediatric primary care.

OBJECTIVE: The goal was to determine the rates of diabetes screening and the prevalence of screening abnormalities in overweight and nonoverweight individuals in an urban primary care clinic. METHODS: This study was a retrospective chart review conducted in a hospital-based urban primary care setting. Deidentified data for patients who were 10 to 19 years of age and had > or = 1 BMI measurement between September 1, 2002, and September 1, 2004, were extracted from the hospital electronic health record. RESULTS: A total of 7710 patients met the study criteria. Patients were 73.0% black or Hispanic and 47.0% female; 42.0% of children exceeded normal weight, with 18.2% at risk for overweight and 23.8% overweight. On the basis of BMI, family history, and race, 8.7% of patients met American Diabetes Association criteria for type 2 diabetes mellitus screening, and 2452 screening tests were performed for 1642 patients. Female gender, older age group, and family history of diabetes were associated with screening. Increasing BMI percentile was associated with screening, exhibiting a dose-response relationship. Screening rates were significantly higher (45.4% vs 19.0%) for patients who met the American Diabetes Association criteria; however, less than one half of adolescents who should have been screened were screened. Abnormal glucose metabolism was seen for 9.2% of patients screened. CONCLUSIONS: This study shows that, although pediatricians are screening for diabetes mellitus, screening is not being conducted according to the American Diabetes Association consensus statement. Point-of-care delivery of consensus recommendations could increase provider awareness of current recommendations, possibly improving rates of systematic screening and subsequent identification of children with laboratory evidence of abnormal glucose metabolism.

Adolescent↗
PubMedDate not supplied

Acupuncture in the treatment of asthma: a critical review.

BACKGROUND: Increasingly, patients are turning to treatments and drugs that are considered "alternative" or "complementary" as part of their healthcare. In response, the National Institutes of Health (NIH) established an Office of Alternative Medicine (OAM) in 1992 to facilitate identification and evaluation of alternative and complementary therapies. Acupuncture, a therapy that has been used to treat disease in China for approximately 2,500 years has attracted considerable attention. NIH in a consensus statement derived from a Fall of 1997 consensus conference to assess acupuncture has indicated that acupuncture was useful in pain control and maybe a useful adjunct treatment for the management of asthma. Further, the US Food and Drug Administration has removed acupuncture from the "experimental medical devices" category. METHODS: We have extensively searched the literature for reports addressing the use of acupuncture in asthma treatment. We sought these using the National Library of Medicine, the Office of Alternative Medicine's database as well as other databases both English language based as well as other languages that catalog literature pertaining to alternative and complementary therapies. We then reviewed these reports and weighted the validity of the conclusions reached in the reports based on assessment of study design, number of subjects studied, duration of studies, types and number of controls, and statistical analyses used. RESULTS: Data presently in the literature do not provide sufficient support for a useful role for acupuncture in asthma management. CONCLUSIONS: Further properly designed clinical studies examining the use of acupuncture in asthma are extremely important and urgently needed.

Acupuncture Therapy↗
PubMed2005

Evaluation and management of apparent life-threatening events in children.

Apparent life-threatening event syndrome predominantly affects children younger than one year. This syndrome is characterized by a frightening constellation of symptoms in which the child exhibits some combination of apnea, change in color, change in muscle tone, coughing, or gagging. Approximately 50 percent of these children are diagnosed with an underlying condition that explains the apparent life-threatening event. Commonly, the problems are digestive (up to 50 percent), neurologic (30 percent), respiratory (20 percent), cardiac (5 percent), and endocrine or metabolic (less than 5 percent). Fifty percent of these events are idiopathic, which causes great concern to parents and physicians. The evaluation of an affected infant involves a thorough description of the event as well as prenatal, birth, medical, social, and family history. The physical examination, including careful neurologic examination and notation of any apparent anatomic abnormalities, helps diagnose congenital problems, infection, and conditions contributing to respiratory compromise. The laboratory evaluation is driven by historical and physical findings. Inpatient evaluation and monitoring are recommended in virtually all cases unless investigations are normal. Should the history reflect a severe episode, or should the child require major interventions such as cardiopulmonary resuscitation, inpatient observation and monitoring are recommended, even if physical examination and laboratory findings are normal. Once a presumptive diagnosis is made, events should cease after appropriate intervention. If not, reviewing the history, performing another physical examination, and reassessing the need for laboratory and imaging studies are the next steps. Although consensus statements by the National Institutes of Health and the American Academy of Pediatrics support home monitoring, the relationship of apparent life-threatening event syndrome to sudden infant death syndrome is controversial.

Apnea↗
PubMed1991

[Consensus Development Conference. Prevention and treatment of osteoporosis].

A consensus development conference sponsored by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the European Foundation for Osteoporosis and Bone Disease and the American National Osteoporosis Foundation was held in Copenhagen in October 1990. The consensus statement is presented (also published in Am J Med 1991; 90:107-10).

Absorptiometry, Photon↗