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PubMed2001

National Institutes of Health Consensus Development Conference statement: adjuvant therapy for breast cancer, November 1-3, 2000.

OBJECTIVE: Our goal was to provide health-care providers, patients, and the general public with an assessment of currently available data regarding the use of adjuvant therapy for breast cancer. PARTICIPANTS: The participants included a non-Federal, non-advocate, 14-member panel representing the fields of oncology, radiology, surgery, pathology, statistics, public health, and health policy as well as patient representatives. In addition, 30 experts in medical oncology, radiation oncology, biostatistics, epidemiology, surgical oncology, and clinical trials presented data to the panel and to a conference audience of 1000. EVIDENCE: The literature was searched with the use of MEDLINE for January 1995 through July 2000, and an extensive bibliography of 2230 references was provided to the panel. Experts prepared abstracts for their conference presentations with relevant citations from the literature. Evidence from randomized clinical trials and evidence from prospective studies were given precedence over clinical anecdotal experience. CONSENSUS PROCESS: The panel, answering predefined questions, developed its conclusions based on the 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 after its release at the conference and was updated with the panel's final revisions. The statement is available at http://consensus.nih.gov. CONCLUSIONS: The panel concludes that decisions regarding adjuvant hormonal therapy should be based on the presence of hormone receptor protein in tumor tissues. Adjuvant hormonal therapy should be offered only to women whose tumors express hormone receptor protein. Because adjuvant polychemotherapy improves survival, it should be recommended to the majority of women with localized breast cancer regardless of lymph node, menopausal, or hormone receptor status. The inclusion of anthracyclines in adjuvant chemotherapy regimens produces a small but statistically significant improvement in survival over non-anthracycline-containing regimens. Available data are currently inconclusive regarding the use of taxanes in adjuvant treatment of lymph node-positive breast cancer. The use of adjuvant dose-intensive chemotherapy regimens in high-risk breast cancer and of taxanes in lymph node-negative breast cancer should be restricted to randomized trials. Ongoing studies evaluating these treatment strategies should be supported to determine if such strategies have a role in adjuvant treatment. Studies to date have included few patients older than 70 years. There is a critical need for trials to evaluate the role of adjuvant chemotherapy in these women. There is evidence that women with a high risk of locoregional tumor recurrence after mastectomy benefit from postoperative radiotherapy. This high-risk group includes women with four or more positive lymph nodes or an advanced primary cancer. Currently, the role of postmastectomy radiotherapy for patients with one to three positive lymph nodes remains uncertain and should be tested in a randomized controlled trial. Individual patients differ in the importance they place on the risks and benefits of adjuvant treatments. Quality of life needs to be evaluated in selected randomized clinical trials to examine the impact of the major acute and long-term side effects of adjuvant treatments, particularly premature menopause, weight gain, mild memory loss, and fatigue. Methods to support shared decision-making between patients and their physicians have been successful in trials; they need to be tailored for diverse populations and should be tested for broader dissemination.

Antineoplastic Agents↗
PubMed2001

National Institutes of Health Consensus Development Conference Statement: adjuvant therapy for breast cancer, November 1-3, 2000.

OBJECTIVE: Our goal was to provide health-care providers, patients, and the general public with an assessment of currently available data regarding the use of adjuvant therapy for breast cancer. PARTICIPANTS: The participants included a non-Federal, non-advocate, 14-member panel representing the fields of oncology, radiology, surgery, pathology, statistics, public health, and health policy as well as patient representatives. In addition, 30 experts in medical oncology, radiation oncology, biostatistics, epidemiology, surgical oncology, and clinical trials presented data to the panel and to a conference audience of 1000. EVIDENCE: The literature was searched with the use of MEDLINE(TM) for January 1995 through July 2000, and an extensive bibliography of 2230 references was provided to the panel. Experts prepared abstracts for their conference presentations with relevant citations from the literature. Evidence from randomized clinical trials and evidence from prospective studies were given precedence over clinical anecdotal experience. CONSENSUS PROCESS: The panel, answering predefined questions, developed its conclusions based on the 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 after its release at the conference and was updated with the panel's final revisions. The statement is available at http://consensus.nih.gov. CONCLUSIONS: The panel concludes that decisions regarding adjuvant hormonal therapy should be based on the presence of hormone receptor protein in tumor tissues. Adjuvant hormonal therapy should be offered only to women whose tumors express hormone receptor protein. Because adjuvant polychemotherapy improves survival, it should be recommended to the majority of women with localized breast cancer regardless of lymph node, menopausal, or hormone receptor status. The inclusion of anthracyclines in adjuvant chemotherapy regimens produces a small but statistically significant improvement in survival over non-anthracycline-containing regimens. Available data are currently inconclusive regarding the use of taxanes in adjuvant treatment of lymph node-positive breast cancer. The use of adjuvant dose-intensive chemotherapy regimens in high-risk breast cancer and of taxanes in lymph node-negative breast cancer should be restricted to randomized trials. Ongoing studies evaluating these treatment strategies should be supported to determine if such strategies have a role in adjuvant treatment. Studies to date have included few patients older than 70 years. There is a critical need for trials to evaluate the role of adjuvant chemotherapy in these women. There is evidence that women with a high risk of locoregional tumor recurrence after mastectomy benefit from postoperative radiotherapy. This high-risk group includes women with four or more positive lymph nodes or an advanced primary cancer. Currently, the role of postmastectomy radiotherapy for patients with one to three positive lymph nodes remains uncertain and should be tested in a randomized controlled trial. Individual patients differ in the importance they place on the risks and benefits of adjuvant treatments. Quality of life needs to be evaluated in selected randomized clinical trials to examine the impact of the major acute and long-term side effects of adjuvant treatments, particularly premature menopause, weight gain, mild memory loss, and fatigue. Methods to support shared decision-making between patients and their physicians have been successful in trials; they need to be tailored for diverse populations and should be tested for broader dissemination.

Adjuvants, Pharmaceutic↗
PubMed1982

Standardization of blood specimen collection procedure for reference values. International Committee for Standardization in Haematology (ICSH).

This document has been prepared by an ICSH Task Force as a proposed ICSH Standard for Blood Specimen Collection for Reference Values. The procedures described are a model for standardization of blood specimen collection either for people confined to bed, or for those who are ambulant; they are intended for obtaining reference values using the principles described in the ICSH paper on the Theory of Reference Values (Clin. lab. Haemat. 3, 369-373, 1981). The document is based on recommendations by the Committee on Reference Values of the Scandinavian Society for Clinical Chemistry and Clinical Physiology as published in Scand. J. clin. lab. Invest. (35, Suppl. 144, 39-43, 1975); it has been prepared in collaboration with the Panel on the Theory of Reference Values of the Scientific Committee of the International Federation of Clinical Chemistry (IFCC). The responsible authorities of ICSH and IFCC have proposed that it should be the basis for joint recommendations by both organizations.

Blood Preservation↗
PubMed1993

Deletion mapping and a highly reduced radiation hybrid in the Xp22.3-p22.2 region.

The human Xp22.3-p22.2 region contains several known disease genes as well as distinctive families of low copy repetitive sequences. In this study, we have developed new tools to more finely map this area. We have characterized a mapping panel of various cell lines and hybrids with different molecular breakpoints as defined by previously mapped reference markers from this region. The panel subdivides this area into nine distinct regions from DXS41 through the pseudoautosomal boundary. We have also identified a radiation-reduced somatic cell hybrid, Z4-7, that contains DXS31, DXS452, STS, DXS143, and DXS85, but not PABX, DXS16, or other single-copy probes from proximal Xp and Xq. A phage library was constructed from Z4-7 and over 80,000 plaques were screened with total human DNA. More than 100 positive clones were identified as potential new markers in this region. Nine of these have been mapped to the hybrid panel, and unique subclones have been isolated from three of these markers. The panel has also allowed us to map several other DNA markers, genes (AMG, OA1), and repetitive elements of the DXF22S and DXF30S sequence families relative to the various breakpoints.

Albinism, Ocular↗
PubMed1995

Changes in cytomorphology of childhood lymphoblastic leukaemia at the time of disease relapse. Childhood Leukaemia Working Party of the United Kingdom Medical Research Council.

AIMS: Children in a United Kingdom national trial for relapsed non-B lymphoblastic leukaemia (ALL) had their diagnostic and relapse marrow cytomorphology compared to see what changes occur during the evolution of the disease. METHODS: Each relapse slide was assessed blindly for French American British (FAB) type and other morphological features by a panel of three independent microscopists without reference to each other or any diagnostic material. Diagnostic slides had been assessed by the same panel on an earlier occasion. RESULTS: A total of 134 consecutive children was studied. Six (5%) were classified as FAB type L2 at diagnosis, compared with 18 (13%) at relapse (a difference of 9%). Twenty two (16%) changed their FAB type, 17 (13%) from L1 to L2 and five (4%) from L2 to L1. The FAB score fell at relapse in 34 children and rose in 14, a difference of 14%. Cell size was the commonest feature to change (increasing in 22 and diminishing in nine) followed by prominent nucleoli (appearing in 21 and disappearing in six). Forty four (33%) children had vacuolated blasts at diagnosis, compared with 48 (36%) at relapse. Twenty five changed their vacuole score substantially, 14 gaining > 10% and 11 falling < 10%. CONCLUSIONS: These findings reflect the variability of lymphoblast cytomorphology, but also show a trend for cells to have more prominent nucleoli and greater size at relapse. Factors controlling these features of the FAB type are unknown, but they may simply be related to the growth fraction of a particular disease and not to any lineage specific biological feature.

Adolescent↗
PubMed2007

Comparative evaluation of Etest and sensititre yeastone panels against the Clinical and Laboratory Standards Institute M27-A2 reference broth microdilution method for testing Candida susceptibility to seven antifungal agents.

To assess their utility for antifungal susceptibility testing in our clinical laboratory, the Etest and Sensititre methods were compared with the Clinical and Laboratory Standards Institute (CLSI) M27-A2 reference broth microdilution method. Fluconazole (FL), itraconazole (I), voriconazole (V), posaconazole (P), flucytosine (FC), caspofungin (C), and amphotericin B (A) were tested with 212 Candida isolates. Reference MICs were determined after 48 h of incubation, and Etest and Sensititre MICs were determined after 24 h and 48 h of incubation. Overall, excellent essential agreement (EA) between the reference and test methods was observed for Etest (95%) and Sensititre (91%). Etest showed an >or=92% EA for MICs for all drugs tested; Sensititre showed a >or=92% EA for MICs for I, FC, A, and C but 82% for FL and 85% for V. The overall categorical agreement (CA) was 90% for Etest and 88% for Sensititre; minor errors accounted for the majority of all categorical errors for both systems. Categorical agreement was lowest for Candida glabrata and Candida tropicalis with both test systems. Etest and Sensititre provided better CA at 24 h compared to 48 h for C. glabrata; however, CA for C. glabrata was <80% for FL with both test systems despite MIC determination at 24 h. Agreement between technologists for both methods was >or=98% for each agent against all organisms tested. Overall, Etest and Sensititre methods compared favorably with the CLSI reference method for determining the susceptibility of Candida. However, further evaluation of their performance for determining the MICs of azoles, particularly for C. glabrata, is warranted.

Antifungal Agents↗
PubMed1992

Clinicians' quick reference guide to postoperative pain management in adults. Pain Management Guideline Panel. Agency for Health Care Policy and Research, US Department of Health and Human Services.

The management of pain is an important part of a health professional's role. The challenge for clinicians is to balance pain control with concern for patient safety and side effects of pain treatments. This is the first of two articles that summarize the highlights of the Agency for Health Care Policy and Research's Panel to develop clinical practice guidelines for the management of pain. This first article includes a summary of the methods used to develop the guidelines and the clinical highlights of pain assessment and management in adults.

Adult↗
PubMed1994

Methods of establishing criteria for purchasing coronary angiography in the investigation of chest pain.

BACKGROUND: Purchasers may now define how many clinical procedures they wish to buy. In the investigation of chest pain, coronary angiography provides a definitive diagnosis. In clinical practice, the use of coronary angiography varies, so purchasers may choose the sort of service they wish to buy. We reviewed the extent of variation in the investigation of patients in the Trent Region and present a system for establishing criteria for the purchase of coronary angiography. METHODS: Three studies are presented, based on patients referred to the three referral centres in the Trent Region. First, the appropriateness for investigation, defined as benefit outweighing risk, is determined by expert panel; second, an audit of patients referred for coronary angiography is presented; and third, the likelihood or probability of significant coronary disease is assessed by application of a logistic regression model. RESULTS: According to the panel criteria, 27 per cent of patients in one centre were judged inappropriate for coronary angiography, 28 per cent in the second centre and 10 per cent in the third. When referred for angiography, extent of anti-anginal medication, symptom severity, use of exercise testing, and result of and planned management after angiography varied widely among centres. The likelihood of significant coronary artery disease could be predicted in 86 per cent of patients. CONCLUSIONS: Variation in clinical practice does not make the purchasers' task easy. Based upon these studies and clinical trials of coronary artery bypass surgery and coronary angioplasty, we present potential performance indicators which may form the basis of contracts or be used as audit measures.

Coronary Angiography↗
PubMed2006

External quality assurance of HER2 fluorescence in situ hybridisation testing: results of a UK NEQAS pilot scheme.

BACKGROUND AND AIMS: Trastuzumab provides clinical benefit for advanced and early breast cancer patients whose tumours over-express or have gene amplification of the HER2 oncogene. The UK National External Quality Assessment Scheme (NEQAS) for immunohistochemical testing was established to assess and improve the quality of HER2 immunohistochemical testing. However, until recently, no provision was available for HER2 fluorescence in situ hybridisation (FISH) testing. A pilot scheme was set up to review the performance of FISH testing in clinical diagnostic laboratories. METHODS: FISH was performed in 6 reference and 31 participating laboratories using a cell line panel with known HER2 status. RESULTS: Using results from reference laboratories as a criterion for acceptable performance, 60% of all results returned by participants were appropriate and 78% either appropriate or acceptable. However, 22.4% of results returned were deemed inappropriate, including 13 cases (4.2%) where a misdiagnosis would have been made had these been clinical specimens. CONCLUSIONS: The results of three consecutive runs show that both reference laboratories and a proportion of routine clinical diagnostic (about 25%) centres can consistently achieve acceptable quality control of HER2 testing. Data from a significant proportion of participating laboratories show that further steps are required, including those taken via review of performance under schemes such as NEQAS, to improve quality of HER2 testing by FISH in the "real world".

Biomarkers, Tumor↗
PubMed2005

Gene expression studies in prostate cancer tissue: which reference gene should be selected for normalization?

Using quantitative reverse transcription-polymerase chain reaction (RT-PCR), reference genes are utilized as endogenous controls for relative quantification of target genes in gene profiling studies. The suitability of housekeeping genes for that purpose in prostate cancer tissue has not been sufficiently investigated so far. The objective of this study was to select from a panel of 16 potential candidate reference genes the most stable genes for gene normalization. Expression of mRNA encoding ACTB, ALAS1, ALB, B2M, G6PD, GAPD, HMBS, HPRT1, K-ALPHA-1, POLR2A, PPIA, RPL13A, SDHA, TBP, UBC, and YWHAZ was examined in matched, microdissected malignant and nonmalignant tissue specimens obtained from 17 nontreated prostate carcinomas after radical prostatectomy by real-time RT-PCR. The genes studied displayed a wide expression range with cycle threshold values between 16 and 37. The expression was not different between samples from pT2 and pT3 tumors or between samples with Gleason scores <7 and >or=7 (P>0.05). ACTB, RPL13A, and HMBS showed significant differences (P<0.02 at least) in expressions between malignant and nonmalignant pairs. All other genes did not differ between the matched pairs, and the software programs geNorm and NormFinder were used to ascertain the most suitable reference genes from these candidates. HPRT1, ALAS1, and K-ALPHA-1 were calculated by both programs to be the most stable genes covering a broad range of expression. The expression of the target gene RECK normalized with HRPT1 alone and with the normalization factors generated by the combination of these three reference genes as well as with the unstable genes ACTB or RPL13A is given. That example shows the significance of using suitable reference genes to avoid erroneous normalizations in gene profiling studies for prostate cancer. The use of HPRT1 alone as a reference gene shown in our study was sufficient, but the normalization factors generated from two (HRPT1, ALAS1) or all three genes (HRPT1, ALAS1, K-ALPHA-1) should be considered for an improved reliability of normalization in gene profiling studies of prostate cancer.

Aged↗
PubMed1998

Effective medical treatment of opiate addiction. National Consensus Development Panel on Effective Medical Treatment of Opiate Addiction.

OBJECTIVE: To provide clinicians, patients, and the general public with a responsible assessment of the effective approaches to treat opiate dependence. PARTICIPANTS: A nonfederal, nonadvocate, 12-member panel representing the fields of psychology, psychiatry, behavioral medicine, family medicine, drug abuse, epidemiology, and the public. In addition, 25 experts from these same fields presented data to the panel and a conference audience of 600. Presentations and discussions were divided into 3 phases over 2 1/2 days: (1) presentations by investigators working in the areas relevant to the consensus questions during a 2-day public session; (2) questions and statements from conference attendees during open discussion periods that are part of the public session; and (3) closed deliberations by the panel during the remainder of the second day and morning of a third day. The conference was organized and supported by the Office of Medical Applications of Research, National Institutes of Health. EVIDENCE: The literature was searched through MEDLINE and other National Library of Medicine and online databases from January 1994 through September 1997 and an extensive bibliography of 941 references was provided to the panel and the conference audience. Experts prepared abstracts for their presentations as speakers at the conference with relevant citations from the literature. Scientific evidence was given precedence over clinical anecdotal experience. CONSENSUS PROCESS: The panel, answering predefined questions, developed its 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: Opiate dependence is a brain-related medical disorder that can be effectively treated with significant benefits for the patient and society, and society must make a commitment to offer effective treatment for opiate dependence to all who need it. All persons dependent on opiates should have access to methadone hydrochloride maintenance therapy under legal supervision, and the US Office of National Drug Control Policy and the US Department of Justice should take the necessary steps to implement this recommendation. There is a need for improved training for physicians and other health care professionals. Training to determine diagnosis and treatment of opiate dependence should also be improved in medical schools. The unnecessary regulations of methadone maintenance therapy and other long-acting opiate agonist treatment programs should be reduced, and coverage for these programs should be a required benefit in public and private insurance programs.

Cost of Illness↗
PubMed1999

Consensus conference. Rehabilitation of persons with traumatic brain injury. NIH Consensus Development Panel on Rehabilitation of Persons With Traumatic Brain Injury.

OBJECTIVE: To provide biomedical researchers and clinicians with information regarding and recommendations for effective rehabilitation measures for persons who have experienced a traumatic brain injury (TBI). PARTICIPANTS: A nonfederal, 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, 31 experts from these same fields presented data to the panel and a conference audience of 883 members of the public. The conference consisted of (1) presentations by investigators working in areas relevant to the consensus questions during a 2-day public session; (2) questions and statements from conference attendees during open discussions that were part of the public session; and (3) closed deliberations by the panel during the remainder of the second day and part of the third. Primary sponsors of the conference were the National Institute of Child Health and Human Development and the National Institutes of Health Office of Medical Applications of Research. EVIDENCE: The literature was searched through MEDLINE for articles from January 1988 through August 1998 and an extensive bibliography of 2563 references was provided to the panel and the conference audience. Experts prepared abstracts for their conference presentations with relevant citations from the literature. The panel prepared a compendium of evidence, including a patient contribution and reports from federal agencies. 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 during the open forum (October 26-28, 1998) and in 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 Internet immediately following its release at the conference and was updated with the panel's final revisions. CONCLUSIONS: Traumatic brain injury results principally from vehicular incidents, falls, acts of violence, and sports injuries and is more than twice as likely to occur in men as in women. The estimated incidence rate is 100 per 100000 persons, with 52000 annual deaths. The highest incidence is among persons aged 15 to 24 years and 75 years or older, with a less striking peak in incidence in children aged 5 years or younger. Since TBI may result in lifelong impairment of physical, cognitive, and psychosocial functioning and prevalence is estimated at 2.5 million to 6.5 million individuals, TBI is a disorder of major public health significance. Mild TBI is significantly underdiagnosed and the likely societal burden is 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 for the cognitive and behavioral consequences of TBI. 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 and, thus, funding for research on TBI needs to be increased.

Adolescent↗
PubMed1999

Minicircle variable region probes for characterization of Leishmania (Viannia) species.

The minicircle molecules present in the kinetoplast DNA (kDNA) network constitute a particularly useful molecular tool because they are a multicopy target and present a variable region that differs among minicircle classes in the same network. Using the polymerase chain reaction (PCR) and a set of primers directed outwardly from the minicircle conserved region, it is possible to prepare molecular probes representing the pool of variable regions from the different minicircle classes in the kDNA. In order to examine the specificity of the minicircle variable region as hybridization probes in Leishmania (Viannia) species, such fragments were amplified from reference strains and from a panel of isolates representing the zymodeme diversity of Leishmania (Viannia) in Colombia. The size of the amplified products was conserved in Leishmania (Viannia) braziliensis, Leishmania (Viannia) guyanensis, and Leishmania (Viannia) panamensis (650 bp) and diverged in Leishmania (Viannia) equatorensis and Leishmania (Viannia) colombiensis (850 bp). The amplified products were further hybridized to variable region pools of Leishmania braziliensis, Leishmania panamensis, Leishmania guyanensis, and Leishmania equatorensis reference strains. The results obtained from the hybridization experiments support this approach as a means of defining relationships among strains. Hybridization allowed homologies to be perceived, whereas restriction fragment length analysis of the amplified products yielded strain-specific profiles. Apparently, L. (V.) equatorensis and L. (V.) colombiensis minicircle variable regions have no or only low homology with those of other Leishmania (Viannia) species, showing the divergence of those species within the subgenus.

Animals↗
PubMedDate not supplied

Salvage radiotherapy for biochemical and clinical failures following radical prostatectomy.

PURPOSE: The proportion of prostate cancer patients undergoing radical prostatectomy has increased over the past 10 to 15 years. It is conceivable that a corresponding increase in local tumor recurrences after prostatectomies will be observed. The role of salvage radiotherapy is presently unclear. In this study, the results of salvage radiotherapy for patients with biochemical evidence of local recurrence, as evidenced from rising prostate-specific antigen (PSA) levels, after radical prostatectomy at UCLA Medical Center and the West Los Angeles Veterans Administration Medical Center are described. PATIENTS AND METHODS: Between 1990 and 1997, 69 patients were diagnosed with presumed local tumor recurrence after radical prostatectomy. Of these patients, 60 patients were referred to radiotherapy for salvage treatments. Tumor recurrence was detected biochemically, with or without a palpable nodule on digital rectal examination, and a metastatic workup revealing no evidence of extrapelvic disease. Biochemical failure after salvage radiotherapy was defined as two consecutive rises in serum PSA level after a PSA nadir or an absence of a PSA nadir after radiation treatments, as was earlier defined at the ASTRO Consensus Panel on PSA Guidelines. Patients referred for adjuvant postoperative radiation treatment and patients with metastatic disease at presentation were excluded from the study. Patients were treated with a four-field approach (anteroposterior/posteroanterior and opposing laterals) to a median dose of 64.8 Gy in 1.8-Gy fractions. Follow-up evaluations included serum PSA level and digital rectal examination every 3 to 6 months. RESULTS: At last follow-up (mean follow-up, 36 months after salvage radiotherapy), 40 of 60 patients (67%) were biochemically free of disease. Thirty of 60 patients (50%) had undetectable PSA levels, and 55 of 60 (92%) had achieved some initial decrease after salvage radiation treatments. Three-year and 5-year actuarial biochemical disease-free survival was 63% and 55%, respectively. Of the 20 patients with biochemical failure after salvage radiation therapy, 10 patients (50%) developed distant metastases, and two (10%) patients were found to have persistent local disease. The mean time to biochemical relapse after salvage radiotherapy was 10 months, and the mean time to distant metastasis after salvage radiotherapy was 20 months. Evaluation of the remaining eight biochemical failures (43%) revealed no evidence of local disease progression or distant metastasis to date. Univariate and multivariate analyses revealed that both PSA > 1.0 ng/mL at the time of salvage radiotherapy and perineural invasion significant prognosticators for biochemical relapse after salvage radiotherapy. Likewise, both univariate and multivariate analyses revealed that prognosticators for distant metastasis included seminal vesicle invasion and perineural invasion. DISCUSSION: Salvage radiation therapy is a viable option for post prostatectomy local tumor recurrences. Of the patients who fail biochemically after salvage radiotherapy, 50% were eventually found to have distant metastases. In addition, biopsy-proven local recurrence after-prostatectomy was found not to confer an adverse outcome after salvage radiotherapy.

Analysis of Variance↗
PubMed1998

NIH Consensus Conference. Acupuncture.

OBJECTIVE: To provide clinicians, patients, and the general public with a responsible assessment of the use and effectiveness of acupuncture to treat a variety of conditions. PARTICIPANTS: A nonfederal, 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 representatives of the public. In addition, 25 experts from these same fields presented data to the panel and a conference audience of 1200. Presentations and discussions were divided into 3 phases over 2 1/2 days: (1) presentations by investigators working in areas relevant to the consensus questions during a 2-day public session; (2) questions and statements from conference attendees during open discussion periods that were part of the public session; and (3) closed deliberations by the panel during the remainder of the second day and morning of the third. The conference was organized and supported by the Office of Alternative Medicine and the Office of Medical Applications of Research, National Institutes of Health, Bethesda, Md. EVIDENCE: The literature, produced from January 1970 to October 1997, was searched through MEDLINE, Allied and Alternative Medicine, EMBASE, and MANTIS, as well as through a hand search of 9 journals that were not indexed by the National Library of Medicine. An extensive bibliography of 2302 references was provided to the panel and the conference audience. Expert speakers prepared abstracts of their own conference presentations 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 the open forum and 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 within a few weeks of the conference. The statement is available at http://consensus.nih.gov. CONCLUSIONS: Acupuncture as a therapeutic intervention is widely practiced in the United States. Although 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 Therapy↗
PubMed2025

Rapid and accurate sepsis diagnostics via a novel probe-based multiplex real-time PCR system.

Sepsis is a critical clinical emergency that requires prompt diagnosis and intervention. Its prevalence has increased due to the aging population and increased antibiotic resistance. Early identification and the use of innovative technologies are crucial for improving patient outcomes. Modern methodologies are needed to minimize the turnaround time for diagnosis and improve outcomes. Rapid diagnostic tests and multiplex PCR are effective but have limitations in identifying a range of pathogens and target genes. Our study evaluated two novel probe-based multiplex real-time PCR systems: the SEPSI ID and SEPSI DR panels. These systems can quickly identify bacterial and fungal pathogens, alongside antibiotic resistance genes. The assays cover 29 microorganisms (gram-negative bacteria, gram-positive bacteria, yeast, and mold species), alongside 23 resistance genes and four virulence factors. A streamlined workflow uses 2 &#xb5;L of broth from positive blood cultures (BCs) without nucleic acid extraction and provides results in approximately 1 h. We present the results from an evaluation of 228 BCs and 22 isolates previously characterized by whole-genome sequencing. In comparison to the reference methods, the SEPSI ID panel demonstrated a sensitivity of 96.88%, a specificity of 100%, and a PPV of 100%, whereas the SEPSI DR panel showed a sensitivity of 97.8%, a PPV of 89.7%, and a specificity of 96.7%. Both panels also identified additional pathogens and resistance-related targets not detected by conventional methods. This assay shows promise for rapidly and accurately diagnosing sepsis. Future studies should validate its performance in various clinical settings to enhance sepsis management and improve patient outcomes.IMPORTANCEWe present a new diagnostic method that enables the quick and precise identification of pathogens and resistance genes from positive blood cultures, eliminating the need for nucleic acid extraction. This technique can also be used on fresh pathogen cultures. It has the potential to greatly improve treatment protocols, leading to better patient outcomes, more responsible antibiotic use, and more efficient management of healthcare resources.

Humans↗
PubMed1988

Reliability of ratings of perceived effort regulation of exercise intensity.

This study assessed the reliability of ratings of perceived exertion (RPE) for the prescription of exercise intensity during cycling. Ten healthy men (21 to 62 years) and six women (25 to 50 years) attended the laboratory four times, 5 to 7 days apart. On the first visit each subject's maximal oxygen uptake was measured and, subsequently, they cycled at constant work rates based on their perception of ratings 9, 13 and 17 of the Borg 6-20 scale by regulating the resistance of the ergometer without reference to the instrument display panel. Analysis of variance revealed no significant between-trial differences with regard to oxygen uptake (VO2) or heart rate for men or women. The relative exercise intensities corresponding to the 3 ratings of exertion did not differ between men and women. Between-trial correlations for VO2 were highest for visits two and three at RPE levels 9 and 13 (r = 0.83 and r = 0.94) and consistently high (r = 0.92 or greater) for the three trials at RPE17. These data suggest that RPE is a useful frame of reference for the regulation of high levels of exercise intensity in healthy men and women. Small amounts of practice with the scale improve its applicability at lower exercise levels.

Adolescent↗