Further reductions in nonvertebral fracture rate with long-term denosumab treatment in the FREEDOM open-label extension and influence of hip bone mineral density after 3 years

Limited data exist on the efficacy of long-term therapies for osteoporosis. In osteoporotic postmenopausal women receiving denosumab for 7 years, nonvertebral fracture rates significantly decreased in years 4-7 versus years 1-3. This is the first demonstration of a further benefit on fracture outcomes with long-term therapy for osteoporosis. INTRODUCTION This study aimed to evaluate whether denosumab treatment continued beyond 3 years is associated with a further reduction in nonvertebral fracture rates. METHODS Participants who completed the 3-year placebo-controlled Fracture REduction Evaluation of Denosumab in Osteoporosis every 6 Months (FREEDOM) study were invited to participate in an open-label extension. The present analysis includes 4,074 postmenopausal women with osteoporosis (n = 2,343 long-term; n = 1,731 cross-over) who enrolled in the extension, missed ≤1 dose during their first 3 years of denosumab treatment, and continued into the fourth year of treatment. Comparison of nonvertebral fracture rates during years 1-3 of denosumab with that of the fourth year and with the rate during years 4-7 was evaluated. RESULTS For the combined group, the nonvertebral fracture rate per 100 participant-years was 2.15 for the first 3 years of denosumab treatment (referent) and 1.36 in the fourth year (rate ratio [RR] = 0.64; 95 % confidence interval (CI) = 0.48 to 0.85, p = 0.003). Comparable findings were observed in the groups separately and when nonvertebral fracture rates during years 1-3 were compared to years 4-7 in the long-term group (RR = 0.79; 95 % CI = 0.62 to 1.00, p = 0.046). Fracture rate reductions in year 4 were most prominent in subjects with persisting low hip bone mineral density (BMD). CONCLUSIONS Denosumab treatment beyond 3 years was associated with a further reduction in nonvertebral fracture rate that persisted through 7 years of continuous denosumab administration. The degree to which denosumab further reduces nonvertebral fracture risk appears influenced by the hip bone density achieved with initial therapy.

Does Full Wound Rupture following Median Pilonidal Closure Alter Long-Term Recurrence Rate?

OBJECTIVE The purpose of this study was to examine the recurrence rate of wound rupture in primary pilonidal sinus disease (PSD) after median closure. SUBJECTS AND METHODS A total of 583 patients from the German military cohort were interviewed. We compared the choice of surgical therapy, wound dehiscence (if present) and long-term recurrence-free survival for patients with primary open treatment, marsupialization and primary median treatment (closed vs. secondary open, respectively). Actuarial recurrence rate was determined using the Kaplan-Meier calculation with a follow-up of up to 20 years after primary PSD surgery. RESULTS Patients with excision followed by primary open wound treatment showed a significantly lower 5- than 10-year recurrence rate (8.3 vs. 11.2%) compared to the patients with primary midline closure (17.4 vs. 20.5%, p = 0.03). The 20-year recurrence rate was 28% in primary open wound treatment versus 44% in primary midline closure without wound rupture. In contrast to these findings, long-term recurrence rates following secondary open wound treatment (12.2% at 5 years vs. 17.1% at 10 years) tended to be higher (although not significantly, p = 0.57) compared to primary open treatment (8.3% at 5 years vs. 11.2% at 10 years). There was no statistical difference in long-term recurrence rates between secondary open and primary midline closure (p = 0.7). Hence, despite only a short wound closure time experienced before wound rupture, the patient does not fully benefit from an open wound treatment in terms of recurrence rate. CONCLUSION The postoperative pilonidal sinus wound rupture of primary midline closures did not significantly increase the 5- and 10-year long-term recurrence rates compared to uneventfully healing primary midline closures.

Long-term evaluation of Class II subdivision treatment with unilateral maxillary first molar extraction

OBJECTIVE To evaluate the long-term effects of asymmetrical maxillary first molar (M1) extraction in Class II subdivision treatment. MATERIALS AND METHODS Records of 20 Class II subdivision whites (7 boys, 13 girls; mean age, 13.0 years; SD, 1.7 years) consecutively treated with the Begg technique and M1 extraction, and 15 untreated asymmetrical Class II adolescents (4 boys, 11 girls; mean age, 12.2 years; SD, 1.3 years) were examined in this study. Cephalometric analysis and PAR assessment were carried out before treatment (T1), after treatment (T2), and on average 2.5 years posttreatment (T3) for the treatment group, and at similar time points and average follow-up of 1.8 years for the controls. RESULTS The adjusted analysis indicated that the maxillary incisors were 2.3 mm more retracted in relation to A-Pog between T1 and T3 (β  =  2.31; 95% CI; 0.76, 3.87), whereas the mandibular incisors were 1.3 mm more protracted (β  =  1.34; 95% CI; 0.09, 2.59), and 5.9° more proclined to the mandibular plane (β  =  5.92; 95% CI; 1.43, 10.41) compared with controls. The lower lip appeared 1.4 mm more protrusive relative to the subnasale-soft tissue-Pog line throughout the observation period in the treated adolescents (β  =  1.43; 95% CI; 0.18, 2.67). There was a significant PAR score reduction over the entire follow-up period in the molar extraction group (β  =  -6.73; 95% CI; -10.7, -2.7). At T2, 65% of the subjects had maxillary midlines perfectly aligned with the face. CONCLUSIONS Unilateral M1 extraction in asymmetrical Class II cases may lead to favorable occlusal outcomes in the long term without harming the midline esthetics and soft tissue profile.

Long-term outcome of patients with newly diagnosed chronic myeloid leukemia: a randomized comparison of stem cell transplantation with drug treatment.

Tyrosine kinase inhibitors represent today's treatment of choice in chronic myeloid leukemia (CML). Allogeneic hematopoietic stem cell transplantation (HSCT) is regarded as salvage therapy. This prospective randomized CML-study IIIA recruited 669 patients with newly diagnosed CML between July 1997 and January 2004 from 143 centers. Of these, 427 patients were considered eligible for HSCT and were randomized by availability of a matched family donor between primary HSCT (group A; N=166 patients) and best available drug treatment (group B; N=261). Primary end point was long-term survival. Survival probabilities were not different between groups A and B (10-year survival: 0.76 (95% confidence interval (CI): 0.69-0.82) vs 0.69 (95% CI: 0.61-0.76)), but influenced by disease and transplant risk. Patients with a low transplant risk showed superior survival compared with patients with high- (P<0.001) and non-high-risk disease (P=0.047) in group B; after entering blast crisis, survival was not different with or without HSCT. Significantly more patients in group A were in molecular remission (56% vs 39%; P=0.005) and free of drug treatment (56% vs 6%; P<0.001). Differences in symptoms and Karnofsky score were not significant. In the era of tyrosine kinase inhibitors, HSCT remains a valid option when both disease and transplant risk are considered.Leukemia advance online publication, 20 November 2015; doi:10.1038/leu.2015.281.

Employment Situation of Parents of Long-Term Childhood Cancer Survivors.

BACKGROUND Taking care of children diagnosed with cancer affects parents' professional life. The impact in the long-term however, is not clear. We aimed to compare the employment situation of parents of long-term childhood cancer survivors with control parents of the general population, and to identify clinical and socio-demographic factors associated with parental employment. METHODS As part of the Swiss Childhood Cancer Survivor Study, we sent a questionnaire to parents of survivors aged 5-15 years, who survived ≥5 years after diagnosis. Information on control parents of the general population came from the Swiss Health Survey (restricted to men and women with ≥1 child aged 5-15 years). Employment was categorized as not employed, part-time, and full-time employed. We used generalized ordered logistic regression to determine associations with clinical and socio-demographic factors. Clinical data was available from the Swiss Childhood Cancer Registry. RESULTS We included 394 parent-couples of survivors and 3'341 control parents (1'731 mothers; 1'610 fathers). Mothers of survivors were more often not employed (29% versus 22%; ptrend = 0.007). However, no differences between mothers were found in multivariable analysis. Fathers of survivors were more often employed full-time (93% versus 87%; ptrend = 0.002), which remained significant in multivariable analysis. Among parents of survivors, mothers with tertiary education (OR = 2.40, CI:1.14-5.07) were more likely to be employed. Having a migration background (OR = 3.63, CI: 1.71-7.71) increased the likelihood of being full-time employed in mothers of survivors. Less likely to be employed were mothers of survivors diagnosed with lymphoma (OR = 0.31, CI:0.13-0.73) and >2 children (OR = 0.48, CI:0.30-0.75); and fathers of survivors who had had a relapse (OR = 0.13, CI:0.04-0.36). CONCLUSION Employment situation of parents of long-term survivors reflected the more traditional parenting roles. Specific support for parents with low education, additional children, and whose child had a more severe cancer disease could improve their long-term employment situation.

Sediment mobilization deposits from episodic subsurface fluid flow—A new tool to reveal long-term earthquake records?

Subsurface fluid flow can be affected by earthquakes; increased spring activity, mud vol- cano eruptions, groundwater fluctuations, changes in geyser frequency, and other forms of altered subsurface fluid flow have been documented during, after, or even prior to seismic shaking. Recently discovered giant pockmarks on the bottom of Lake Neuchâtel, Switzerland, are the lake-floor expression of subsurface fluid flow. They discharge groundwater from the Jura Mountains karstic aquifers and experience episodically increased subsurface fluid flow documented by subsurface sediment mobilization deposits at the levees of the pockmarks. In this study, we present the spatio-temporal distribution of event deposits from these phases of sediment expulsion and of multiple time-correlative mass-transport deposits. We report five striking instances of concurrent multiple subsurface sediment deposits and multiple mass- transport deposits since late glacial times, for which we propose past earthquakes as a trigger. Comparison of this new event catalogue with historic earthquakes and other independent paleoseismic records suggests that initiation of sediment expulsion requires a minimum mac- roseismic intensity of VII. Thus, our study presents for the first time sedimentary deposits resulting from increased subsurface fluid flow as a paleoseismic proxy.

Long-term Outcome After Monosegmental L4/5 Stabilization for Degenerative Spondylolisthesis With the Dynesys Device.

STUDY DESIGN Retrospective analysis of prospectively collected clinical data. OBJECTIVE To assess the long-term outcome of patients with monosegmental L4/5 degenerative spondylolisthesis treated with the dynamic Dynesys device. SUMMARY OF BACKGROUND DATA The Dynesys system has been used as a semirigid, lumbar dorsal pedicular stabilization device since 1994. Good short-term results have been reported, but little is known about the long-term outcome after treatment for degenerative spondylolisthesis at the L4/5 level. METHODS A total of 39 consecutive patients with symptomatic degenerative lumbar spondylolisthesis at the L4/5 level were treated with bilateral decompression and Dynesys instrumentation. At a mean follow-up of 7.2 years (range, 5.0-11.2 y), they underwent clinical and radiographic evaluation and quality of life assessment. RESULTS At final follow-up, back pain improved in 89% and leg pain improved in 86% of patients compared with preoperative status. Eighty-three percent of patients reported global subjective improvement. Ninety-two percent would undergo the surgery again. Eight patients (21%) required further surgery because of symptomatic adjacent segment disease (6 cases), late-onset infection (1 case), and screw breakage (1 case). In 9 cases, radiologic progression of spondylolisthesis at the operated segment was found. Seventy-four percent of operated segments showed limited flexion-extension range of <4 degrees. Adjacent segment pathology, although without clinical correlation, was diagnosed at the L5/S1 (17.9%) and L3/4 (28.2%) segments. In 4 cases, asymptomatic screw loosening was observed. CONCLUSIONS Monosegmental Dynesys instrumentation of degenerative spondylolisthesis at L4/5 shows good long-term results. The rate of secondary surgeries is comparable to other dorsal instrumentation devices. Residual range of motion in the stabilized segment is reduced, and the rate of radiologic and symptomatic adjacent segment degeneration is low. Patient satisfaction is high. Dynesys stabilization of symptomatic L4/5 degenerative spondylolisthesis is a possible alternative to other stabilization devices.

Perspective transformation: Women in long-term recovery from alcohol abuse

Objective. The purpose of this study was to determine the meaning of personal transformation for twenty women in long term, stable recovery from alcohol abuse; to identify themes or patterns of this recovery, and; to determine the extent to which they experienced the phenomenon of perspective transformation. ^ Method. Volunteers were recruited by advertisement, word of mouth, and through a closed circuit web based broadcast. A descriptive, exploratory study, which analyzed perspective transformation from the standpoint of five action phases, was conducted. Data was collected using in-depth personal interviews and questionnaires. Subjects' responses were analyzed by qualitative methods. Triangulation was performed on the grouped data comparing the interviews to the data produced by the questionnaires. Quantitative analysis of questionnaire items explored behavioral changes experienced before and after alcoholism recovery. ^ Results. Five phases of recovery were identified. Phase I which involved recognition that alcohol was a problem and change might be possible took several years during which 3 major transitions occurred: (1) from often being alienated to having relationships with family and friends; (2) from daily upheavals to eventually a more peaceful existence, and; (3) from denial that alcohol was a problem to acceptance and willingness to change. Recovery was often seen in a spiritual context, which also required ongoing support. During Phase II there was an assessment of self, others, and the environment which revealed a pattern of intense unhappiness and negative feelings toward self and others with a disregard for cultural norms. Phase III revealed a period of desperation as life became unmanageable, but gradual willingness to accept support and guidance and a desire to improve self and help others. This led to improvement of existing role performance and the willingness to try out new roles. In Phase IV there was a pattern of personal growth which included: the establishment of boundaries, setting priorities, a willingness to place others' needs above their own, acceptance of responsibility, and learning to cope without alcohol, often with the use of tools learned in AA. During Phase V, many experienced knowledge of frailties but growing respect for self and others, with an improved ability to function in giving relationships. Implications for Prevention and Recovery: Early education concerning addiction and recovery may play a crucial role in prevention and early recovery, as it did for children of women in this study. Recovery requires persistent effort and organized support. ^

Long-term central venous catheter-related candidemia: A new approach towards diagnosis and management

A case-series analysis of approximately 811 cancer patients who developed Candidemia between 1989 and 1998 and seen at M. D. Anderson Cancer Center, was studied to assess the impact and timing of central venous catheter (CVC) removal on the outcome of fungal bloodstream infections in cancer patients with primary catheter-related Candidemia as well as secondary infections. ^ This study explored the diagnosis and the management of vascular catheter-associated fungemia in patients with cancer. The microbiologic and clinical factors were determined to predict catheter-related Candidemia. Those factors included, in addition to basic demographics, the underlying malignancy, chemotherapy, neutropenia, and other salient data. Statistical analyses included univariate and multivariate logistic regression to determine the outcome of Candidemia in relation to the timing of catheter removal, type of species, and to identify predictors of catheter-related infections. ^ The conclusions of the study aim at enhancing our mastery of issues involving CVC removal and potentially will have an impact on the management of nosocomial bloodstream infections related to timing of CVC removal and the optimal duration of treatment of catheter-related Candidemia. ^

Financial impact of the Medicare prospective payment system on long term acute care hospitals

Objective. Long Term Acute Care Hospitals (LTACs) are subject to Medicare rules because they accept Medicare and Medicaid patients. In October 2002, Medicare changed the LTAC reimbursement formulas, from a cost basis system to a Prospective Payment System (PPS). This study examines whether the PPS has negatively affected the financial performance of the LTAC hospitals in the period following the reimbursement change (2003-2006), as compared to the period prior to the change (1999-2003), and if so, to what extent. This study will also examine whether the PPS has resulted in a decreased average patient length of stay (LOS) in the LTAC hospitals for the period of 2003-2006 as compared to the prior period of 1999-2003, and if so, to what extent. ^ Methods. The study group consists of two large LTAC hospital systems, Kindred Healthcare Inc. and Select Specialty Hospitals of Select Medical Corporation. Financial data and operational indicators were reviewed, tabulated and dichotomized into two groups, covering the two periods: 1999-2002 and 2003-2006. The financial data included net annual revenues, net income, revenue per patient per day and profit margins. It was hypothesized that the profit margins for the LTAC hospitals were reduced because of the new PPS. Operational indicators, such as annual admissions, annual patient days, and average LOS were analyzed. It was hypothesized that LOS for the LTAC hospitals would have decreased. Case mix index, defined as the weighted average of patients’ DRGs for each hospital system, was not available to cast more light on the direction of LOS. ^ Results. This assessment found that the negative financial impacts did not materialize; instead, financial performance improved during the PPS period (2003-2006). The income margin percentage under the PPS increased for Kindred by 24%, and for Select by 77%. Thus, the study’s working hypothesis of reduced income margins for the LTACs under the PPS was contradicted. As to the average patient length of stay, LOS decreased from 34.7 days to 29.4 days for Kindred, and from 30.5 days to 25.3 days for Select. Thus, on the issue of LTAC shorter length of stay, the study’s working hypothesis was confirmed. ^ Conclusion. Overall, there was no negative financial effect on the LTAC hospitals during the period of 2003-2006 following Medicare implementation of the PPS in October 2002. On the contrary, the income margins improved significantly. ^ During the same period, LOS decreased following the implementation of the PPS. This was consistent with the LTAC hospitals’ pursuit of financial incentives.^

Financial impact of the Medicare prospective payment system on long term acute care hospitals

Objective. Long Term Acute Care Hospitals (LTACs) are subject to Medicare rules because they accept Medicare and Medicaid patients. In October 2002, Medicare changed the LTAC reimbursement formulas, from a cost basis system to a Prospective Payment System (PPS). This study examines whether the PPS has negatively affected the financial performance of the LTAC hospitals in the period following the reimbursement change (2003–2006), as compared to the period prior to the change (1999–2003), and if so, to what extent. This study will also examine whether the PPS has resulted in a decreased average patient length of stay (LOS) in the LTAC hospitals for the period of 2003–2006 as compared to the prior period of 1999-2003, and if so, to what extent. ^ Methods. The study group consists of two large LTAC hospital systems, Kindred Healthcare Inc. and Select Specialty Hospitals of Select Medical Corporation. Financial data and operational indicators were reviewed, tabulated and dichotomized into two groups, covering the two periods: 1999–2002 and 2003–2006. The financial data included net annual revenues, net income, revenue per patient per day and profit margins. It was hypothesized that the profit margins for the LTAC hospitals were reduced because of the new PPS. Operational indicators, such as annual admissions, annual patient days, and average LOS were analyzed. It was hypothesized that LOS for the LTAC hospitals would have decreased. Case mix index, defined as the weighted average of patients’ DRGs for each hospital system, was not available to cast more light on the direction of LOS. ^ Results. This assessment found that the negative financial impacts did not materialize; instead, financial performance improved during the PPS period (2003–2006). The income margin percentage under the PPS increased for Kindred by 24%, and for Select by 77%. Thus, the study’s working hypothesis of reduced income margins for the LTACs under the PPS was contradicted. As to the average patient length of stay, LOS decreased from 34.7 days to 29.4 days for Kindred, and from 30.5 days to 25.3 days for Select. Thus, on the issue of LTAC shorter length of stay, the study’s working hypothesis was confirmed. ^ Conclusion. Overall, there was no negative financial effect on the LTAC hospitals during the period of 2003–2006 following Medicare implementation of the PPS in October 2002. On the contrary, the income margins improved significantly. ^ During the same period, LOS decreased following the implementation of the PPS. This was consistent with the LTAC hospitals’ pursuit of financial incentives. ^

Long-term gastrointestinal complications of Clostridium difficile associated diarrhea (CDAD)

Background. The incidence of Clostridium difficile -associated diarrhea (CDAD) is increasing worldwide likely because of increased use of broad spectrum antibiotics and the introduction of a clonal hyper-virulent strain called the BI strain. Short-term complications of CDAD include recurrent disease, requirement for colectomy, and persistent disease. However, data on the long-term consequences of CDAD are scarce. Among other infectious diseases (Shigella, Salmonella, and Campylobacter), long-term consequences such as irritable bowel syndrome (IBS), chronic dyspepsia/diarrhea, and other GI effects have been noted. Since the mechanism of action of these agents is similar to C.difficile, we hypothesized that patients with CDAD have greater likelihood of developing IBS and other functional gastrointestinal disorders (FGIDs) in the long-term as compared to a general sample of recently hospitalized patients. ^ Objective. To evaluate the long-term gastrointestinal complications of CDAD, (IBS, functional diarrhea, functional abdominal bloating, functional constipation and functional abdominal pain syndrome). ^ Methods. The current study was a secondary analysis of a previously completed observational case-control outcome study. Adult CDAD patients at St. Luke's Episcopal Hospital, Houston (SLEH) were followed up and interviewed by telephone six months after the initial diagnosis thereafter evaluated for the development of IBS and other FGIDs. A total of 46 patients with CDAD infection were recruited at SLEH between May-November 2007. The comparators were patients hospitalized in SLEH within one month before or after the admission of the reference case, hospital length of stay within one week longer or shorter than reference case, and age within 10 years more or less than the reference case. Cases and comparators were compared using Fisher's exact test. A p<0.05 was considered significant. ^ Results. Thirty CDAD patients responded to the questionnaires and were compared to 40 comparators. No comparator developed a FGID, while 3 (10%) CDAD patients developed new onset IBS (p=0.07), 4 (13.3%) developed new onset Functional Diarrhea (p=0.03), and 3 (10%) developed new onset Functional Constipation (p=0.07). No patient developed Functional Abdominal Bloating and Functional Abdominal Pain Syndrome. ^ Conclusion. In this study, new onset functional diarrhea was significantly more common in patients CDAD within six months after initial infection compared to matched controls.^

The impact of Medicare, Medicaid and Schip Extension Act of 2007 (MMSEA) on the long term acute care hospitals

The Long Term Acute Care Hospitals (LTACH), which serve medically complex patients, have grown tremendously in recent years, by expanding the number of Medicare patient admissions and thus increasing Medicare expenditures (Stark 2004). In an attempt to mitigate the rapid growth of the LTACHs and reduce related Medicare expenditures, Congress enacted Section 114 of P.L. 110-173 (§114) of the Medicare, Medicaid and SCHIP Extension Act (MMSEA) in December 29, 2007 to regulate the LTCAHs industry. MMSEA increased the medical necessity reviews for Medicare admissions, imposed a moratorium on new LTCAHs, and allowed the Centers for Medicare and Medicaid Services (CMS) to recoup Medicare overpayments for unnecessary admissions. ^ This study examines whether MMSEA impacted LTACH admissions, operating margins and efficiency. These objectives were analyzed by comparing LTACH data for 2008 (post MMSEA) and data for 2006-2007 (pre-MMSEA). Secondary data were utilized from the American Hospital Association (AHA) database and the American Hospital Directory (AHD).^ This is a longitudinal retrospective study with a total sample of 55 LTACHs, selected from 396 LTACHs facilities that were fully operational during the study period of 2006-2008. The results of the research found no statistically significant change in total Medicare admissions; instead there was a small but not statistically significant reduction of 5% in Medicare admissions for 2008 in comparison to those for 2006. A statistically significant decrease in mean operating margins was confirmed between the years 2006 and 2008. The LTACHs' Technical Efficiency (TE), as computed by Data Envelopment Analysis (DEA), showed significant decrease in efficiency over the same period. Thirteen of the 55 LTACHs in the sample (24%) in 2006 were calculated as “efficient” utilizing the DEA analysis. This dropped to 13% (7/55) in 2008. Longitudinally, the decrease in efficiency using the DEA extension technique (Malmquist Index or MI) indicated a deterioration of 10% in efficiency over the same period. Interestingly, however, when the sample was stratified into high efficient versus low efficient subgroups (approximately 25% in each group), a comparison of the MIs suggested a significant improvement in Efficiency Change (EC) for the least efficient (MI 0.92022) and reduction in efficiency for the most efficient LTACHs (MI = 1.38761) over same period. While a reduction in efficiency for the most efficient is unexpected, it is not particularly surprising, since efficiency measure can vary over time. An improvement in efficiency, however, for the least efficient should be expected as those LTACHs begin to manage expenses (and controllable resources) more carefully to offset the payment/reimbursement pressures on their margins from MMSEA.^

Syndromic surveillance at a long term shelter for persons displaced by hurricanes Katrina and Rita conducted by the San Antonio Metropolitan Health District

Background. Beginning September 2, 2005, San Antonio area shelters received approximately 12,700 evacuees from Hurricane Katrina. Two weeks later, another 12,000 evacuees from Hurricane Rita arrived. By mid-October, 2005, the in-shelter population was 1,000 people. There was concern regarding the potential for spread of infectious diseases in the shelter. San Antonio Metropolitan Health District (SAMHD) established a syndromic surveillance system with Comprehensive Health Services (CHS) who provided on-site health care. CHS was in daily contact with SAMHD to report symptoms of concern until the shelter closed December 23, 2005. ^ Study type. The objective of this study was to assess the methods used and describe the practical considerations involved in establishing and managing a syndromic surveillance system, as established by the SAMHD in the long-term shelter clinic maintained by CHS for the hurricane evacuees. ^ Methods. Information and descriptive data used in this study was collected from multiple sources, primarily from the San Antonio Metropolitan Health District’s 2006 Report on Syndromic Surveillance of a Long-Term Shelter by Hausler & Rohr-Allegrini. SAMHD and CHS staff ensured that each clinic visit was recorded by date, demographic information, chief complaint and medical disposition. Logs were obtained daily and subsequently entered into a Microsoft Access database and analyzed in Excel. ^ Results. During a nine week period, 4,913 clinic visits were recorded, reviewed and later analyzed. Repeat visits comprised 93.0% of encounters. Chronic illnesses contributed to 21.7% of the visits. Approximately 54.0% were acute care encounters. Of all encounters, 17.3% had infectious disease potential as primarily gastrointestinal and respiratory syndromes. Evacuees accounted for 86% and staff 14% of all visits to the shelter clinic. There were 782 unduplicated individuals who sought services at the clinic, comprised of 63% (496) evacuees and 36% (278) staff members. Staff were more likely to frequent the clinic but for fewer visits each. ^ Conclusion. The presence of health care services and syndromic surveillance provided the opportunity to recognize, document and intervene in any disease outbreak at this long-term shelter. Constant vigilance allowed SAMHD to inform and reassure concerned people living and working in the shelter and living outside the shelter.^

Design of long-term animal bioassay for low-dose extrapolation using a multistage model

Conventional designs of animal bioassays allocate the same number of animals into control and dose groups to explore the spontaneous and induced tumor incidence rates, respectively. The purpose of such bioassays are (a) to determine whether or not the substance exhibits carcinogenic properties, and (b) if so, to estimate the human response at relatively low doses. In this study, it has been found that the optimal allocation to the experimental groups which, in some sense, minimize the error of the estimated response for low dose extrapolation is associated with the dose level and tumor risk. The number of dose levels has been investigated at the affordable experimental cost. The pattern of the administered dose, 1 MTD, 1/2 MTD, 1/4 MTD,....., etc. plus control, gives the most reasonable arrangement for the low dose extrapolation purpose. The arrangement of five dose groups may make the highest dose trivial. A four-dose design can circumvent this problem and has also one degree of freedom for testing the goodness-of-fit of the response model.^ An example using the data on liver tumors induced in mice in a lifetime study of feeding dieldrin (Walker et al., 1973) is implemented with the methodology. The results are compared with conclusions drawn from other studies. ^