Predicting walking function of patients one month poststroke using modified Rivermead mobility index on admission.

Being able to predict walking ability of patients with stroke at an early stage is useful in formulating realistic rehabilitation goals and facilitating early discharge planning, which are beneficial not only to the patients but their family members and health care providers. This study aimed to use the modified Rivermead mobility index (MRMI) of the stroke patients on day 3 of their admission to predict their independent walking ability on day 28 postadmission. A total of 232 patients with acute stroke who were admitted to the acute hospital were recruited. Fifty-three percent of them (n = 123) were able to achieve independent walking ability after 28 days of admission whereas 47.0% of them (n = 109) failed to do so. The receiver operating characteristics curve analysis was performed. The optimal cutoff score with the highest sum of sensitivity and specificity was found to be 18.5 (sensitivity, 85.0%; specificity, 75.0%) and the area under the curve was .880. In conclusion, MRMI on day 3 of admission maybe useful in predicting independent walking ability 1 month after stroke.

Chinese adaptation and validation of the patellofemoral pain severity scale.

OBJECTIVE: This study validated the Patellofemoral Pain Severity Scale translated into Chinese. DESIGN AND SETTING: The Chinese Patellofemoral Pain Severity Scale was translated from the original English version following standard forward and backward translation procedures recommended by the International Society for Pharmacoeconomics and Outcomes Research. The survey was then conducted in clinical settings by a questionnaire comprising the Chinese Patellofemoral Pain Severity Scale, Kujala Scale and Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index. SUBJECTS: Eighty-four Chinese reading patients with patellofemoral pain were recruited from physical therapy clinics. MAIN MEASURES: Internal consistency of the translated instrument was measured by Cronbach alpha. Convergent validity was examined by Spearman rank correlation coefficient (rho) tests by comparing its score with the validated Chinese version of the Kujala Scale and the WOMAC Osteoarthritis Index while the test-retest reliability was evaluated by administering the questionnaires twice. RESULTS: Cronbach alpha values of individual questions and their overall value were above 0.85. Strong association was found between the Chinese Patellofemoral Pain Severity Scale and the Kujala Scale (rho = -0.72, p < 0.001). Moderate correlation was also found between Chinese Patellofemoral Pain Severity Scale with the WOMAC Osteoarthritis Index (rho = 0.63, p < 0.001). Excellent test-retest reliability (Intraclass correlation coefficient = 0.98) was demonstrated. CONCLUSIONS: The Chinese translated version of the Patellofemoral Pain Severity Scale is a reliable and valid instrument for patients with patellofemoral pain.

Vaccination with ALVAC and AIDSVAX to prevent HIV-1 infection in Thailand.

BACKGROUND: The development of a safe and effective vaccine against the human immunodeficiency virus type 1 (HIV-1) is critical to pandemic control. METHODS: In a community-based, randomized, multicenter, double-blind, placebo-controlled efficacy trial, we evaluated four priming injections of a recombinant canarypox vector vaccine (ALVAC-HIV [vCP1521]) plus two booster injections of a recombinant glycoprotein 120 subunit vaccine (AIDSVAX B/E). The vaccine and placebo injections were administered to 16,402 healthy men and women between the ages of 18 and 30 years in Rayong and Chon Buri provinces in Thailand. The volunteers, primarily at heterosexual risk for HIV infection, were monitored for the coprimary end points: HIV-1 infection and early HIV-1 viremia, at the end of the 6-month vaccination series and every 6 months thereafter for 3 years. RESULTS: In the intention-to-treat analysis involving 16,402 subjects, there was a trend toward the prevention of HIV-1 infection among the vaccine recipients, with a vaccine efficacy of 26.4% (95% confidence interval [CI], -4.0 to 47.9; P=0.08). In the per-protocol analysis involving 12,542 subjects, the vaccine efficacy was 26.2% (95% CI, -13.3 to 51.9; P=0.16). In the modified intention-to-treat analysis involving 16,395 subjects (with the exclusion of 7 subjects who were found to have had HIV-1 infection at baseline), the vaccine efficacy was 31.2% (95% CI, 1.1 to 52.1; P=0.04). Vaccination did not affect the degree of viremia or the CD4+ T-cell count in subjects in whom HIV-1 infection was subsequently diagnosed. CONCLUSIONS: This ALVAC-HIV and AIDSVAX B/E vaccine regimen may reduce the risk of HIV infection in a community-based population with largely heterosexual risk. Vaccination did not affect the viral load or CD4+ count in subjects with HIV infection. Although the results show only a modest benefit, they offer insight for future research. (ClinicalTrials.gov number, NCT00223080.)

Accelerating the development of an AIDS vaccine: the AIDS vaccine for Asia Network (Avan).

HIV/AIDS is a major public health problem worldwide, especially in developing countries. The development of a safe and effective HIV vaccine is central to stopping the epidemic and would be a great public health tool. The AIDS Vaccine for Asia Network (AVAN) is a group of concerned investigators committed to assisting regional and global HIV vaccine efforts. AVAN's focus on improving the coordination and harmonization of research, ethical reviews, clinical trial capacity, regulatory frameworks, vaccine manufacturing, community participation, and government advocacy could help accelerate HIV vaccine efforts in the region. At a meeting in November 2010, researchers from various countries in Asia presented their progress in HIV vaccine research and development. Six working groups discussed the current status, gaps and methods to strengthen capacity and infrastructure in various areas related to AIDS vaccine research and development. These discussions led to the development of prioritized action plans for the next 5 years. This report describes the gaps and challenges HIV vaccine research faces in the region and recommends improvement and standardization of facilities, and coordination and harmonization of all activities related to AIDS vaccine research and development, including possible technology transfer when a vaccine becomes available.

Intensity-modulated radiation therapy (IMRT) for meningioma.

PURPOSE: To assess the safety and efficacy of intensity-modulated radiation therapy (IMRT) in the treatment of intracranial meningioma. METHODS AND MATERIALS: Forty patients with intracranial meningioma (excluding optic nerve sheath meningiomas) were treated using IMRT with the NOMOS Peacock system between 1994 and 1999. Twenty-five patients received IMRT after surgery either as adjuvant therapy for incomplete resection or for recurrence, and 15 patients received definitive IMRT after presumptive diagnosis based on imaging. Thirty-two patients had skull base lesions, and 8 had nonskull base lesions. The prescribed dose ranged from 40 to 56 Gy (median 50.4 Gy) at 1.71 to 2 Gy per fraction, and the volume of the primary target ranged from 1.55 to 324.57 cc (median 20.22 cc). The mean dose to the target ranged from 44 to 60 Gy (median 53 Gy). Follow-up ranged from 6 to 71 months (median 30 months). Acute and chronic toxicity were assessed using Radiation Therapy Oncology Group (RTOG) morbidity criteria and tumor response was assessed by patient report, examination, and imaging. Overall survival, progression-free survival, and local control were calculated using the Kaplan-Meier method. RESULTS: Cumulative 5-year local control, progression-free survival, and overall survival were 93%, 88%, and 89%, respectively. Two patients progressed after IMRT, one locally and one distantly. Each was treated with IMRT after multiple recurrences of benign meningioma over many years. Both were found to have malignant meningioma at the time of relapse after IMRT, and it is likely their tumors had already undergone malignant change by the time IMRT was given. Defined normal structures generally received a significantly lower dose than the target. The most common acute central nervous system (CNS) toxicity was mild headache, usually relieved with steroids. One patient experienced RTOG Grade 3 acute CNS toxicity, and 2 experienced Grade 3 or higher late CNS toxicity, with one possible treatment-related death. No toxicity was observed with mean doses to the optic nerve/chiasm up to 47 Gy and maximum doses up to 55 Gy. CONCLUSION: IMRT is a promising new technology that is safe and efficacious in the primary and adjuvant treatment of intracranial meningiomas. A history of local aggression may indicate malignant degeneration and predict a poorer outcome. Toxicity data are encouraging, but the potential for serious side effects exists, as demonstrated by one possible treatment-related death. Larger cohort and longer follow-up are needed to better define efficacy and late toxicity of IMRT.

Chinese translation and validation of the Kujala scale for patients with patellofemoral pain.

PURPOSE: This study translated and validated the Kujala scale, a well-documented questionnaire for patients with patellofemoral pain, into Chinese version. METHOD: Chinese Kujala scale was translated from the original English version following the recommendations of the International Society for Pharmacoeconomics and Outcomes Research. Sixty four Chinese reading patients who are diagnosed of patellofemoral pain were recruited from multiple hospitals and physiotherapy clinics. Psychometric property was evaluated in terms of test-retest reliability and internal consistency. Convergent validity was examined by Spearman rank correlation coefficient tests by comparing its score with the validated Chinese version of WOMAC Osteoarthritis Index and SF-36. RESULTS: Chinese Kujala scale demonstrated excellent reliability (ICC = 0.968, p < 0.001). Cronbach's α of individual questions and its overall value were above 0.7. Strong correlation was found between the Chinese Kujala scale and the WOMAC Osteoarthritis Index (rho = -0.708, p < 0.001). Fairly weak correlations were also found between Chinese Kujala scale with the "physical" (rho = 0.413-0.498, p < 0.001) and "energy vitality" (rho = 0.290, p = 0.02) domains of SF-36. However, the relationship between the "bodily pain" was not significant (rho = 0.136, p = 0.284). CONCLUSION: The Chinese translated version of Kujala scale is a reliable and valid instrument for assessing the patellofemoral pain associated functional disturbances among the patient cohort.

The effects of quadriceps strengthening on pain, function, and patellofemoral joint contact area in persons with patellofemoral pain.

OBJECTIVE: Patellar malalignment is a major cause of patellofemoral pain syndrome (PFPS), but the relationship between clinical symptoms and changes in patellar position and knee muscle strength has not been confirmed. This study examined the effect of weight training on hip and knee muscle strength, patellofemoral joint contact area, and patellar tilt on subjects with and without PFPS, hoping to develop an optimal rehabilitation protocol for subjects with PFPS. DESIGN: The study uses a prospective independent group comparison. Fifteen subjects with and without PFPS were assessed for knee strength, patellofemoral joint contact area, and patellar tilt angle using magnetic resonance imaging. The subjects with PFPS were also examined and given a numeric pain rating score and a Kujala patellofemoral score. The subjects performed lower-limb weight training 3 times/wk for 8 wks, and the outcomes were assessed both before and after training. RESULTS: Subjects with PFPS have increased their patellofemoral joint contact area after weight training (P < 0.001). No statistical significant change was found on the patellar tilt angle. The isometric and isokinetic knee strength in subjects with and without PFPS have increased after weight training (P value increased from 0.007 to 0.05). Both numeric pain rating and Kujala patellofemoral score in the PFPS group improved after training (P < 0.001). CONCLUSIONS: Weight-training exercise increased knee muscle strength and the patellofemoral joint contact area, which could reduce mechanical stress in the joint, improving pain and function in subjects with PFPS.

Validation and reliability of the Physical Activity Scale for the Elderly in Chinese population.

OBJECTIVES: Physical Activity Scale for the Elderly (PASE) is a widely used questionnaire in epidemiological studies for assessing the physical activity level of elderly. This study aims to translate and validate PASE in Chinese population. DESIGN: Cross-sectional study. SUBJECTS: Chinese elderly aged 65 or above. METHODS: The original English version of PASE was translated into Chinese (PASE-C) following standardized translation procedures. Ninety Chinese elderly aged 65 or above were recruited in the community. Test-retest reliability was determined by comparing the scores obtained from two separate administrations by the intraclass correlation coefficient. Validity was evaluated by Spearman's rank correlation coefficients between PASE and Medical Outcome Survey 36-Item Short Form Health Survey (SF-36), grip strength, single-leg-stance, 5 times sit-to-stand and 10-m walk. RESULTS: PASE-C demonstrated good test-retest reliability (intraclass correlation coefficient = 0.81). Fair to moderate association were found between PASE-C and most of the subscales of SF-36 (rs = 0.285 to 0.578, p < 0.01), grip strength (rs = 0.405 to 0.426, p < 0.001), single-leg-stance (rs = 0.470 to 0.548, p < 0.001), 5 times sit-to-stand (rs = -0.33, p = 0.001) and 10-m walk (rs = -0.281, p = 0.007). CONCLUSION: PASE-C is a reliable and valid instrument for assessing the physical activity level of elderly in Chinese population.

Risk behaviour and time as covariates for efficacy of the HIV vaccine regimen ALVAC-HIV (vCP1521) and AIDSVAX B/E: a post-hoc analysis of the Thai phase 3 efficacy trial RV 144.

BACKGROUND: The Thai phase 3 HIV vaccine trial RV 144 showed modest efficacy of a vaccine against HIV acquisition. Baseline variables of age, sex, marital status, and risk did not modify vaccine efficacy. We did a post-hoc analysis of the trial's data to investigate behavioural risk and efficacy every 6 months after vaccination. METHODS: RV 144 was a randomised, multicentre, double-blind, placebo-controlled efficacy trial testing the combination of the HIV vaccines ALVAC-HIV (vCP1521) and AIDSVAX B/E to prevent HIV infection or reduce setpoint viral load. Male and female volunteers aged 18-30 years were recruited from the community. In this post-hoc analysis of the modified intention-to-treat population (16,395 participants), HIV risk behaviour was assessed with a self-administered questionnaire at the time of initial vaccination in the trial and every 6 months thereafter for 3 years. We classified participants' behaviour as low, medium, or high risk. Both the acquisition endpoint and the early viral-load endpoint were examined for interactions with risk status over time and temporal effects after vaccination. Multiple proportional hazards regression models with treatment and time-varying risk covariates were analysed. FINDINGS: Risk of acquisition of HIV was low in each risk group, but 9187 (58·2%) participants reported higher-risk behaviour at least once during the study. Participants classified as high or increasing risk at least once during follow-up were compared with those who maintained low-risk or medium-risk behaviour as a time-varying covariate, and the interaction of risk status and acquisition efficacy was significant (p=0·01), with greater benefit in low-risk individuals. Vaccine efficacy seemed to peak early--cumulative vaccine efficacy was estimated to be 60·5% (95% CI 22-80) through the 12 months after initial vaccination--and declined quickly. Vaccination did not seem to affect viral load in either early or late infections. INTERPRETATION: Future HIV vaccine trials should recognise potential interactions between challenge intensity and risk heterogeneity in both population and treatment effects. The regimen tested in the RV 144 phase 3 trial might benefit from extended immunisation schedules. FUNDING: US Army Medical Research and Materiel Command and Division of AIDS, National Institute of Allergy and Infectious Disease, National Institutes of Health.

Safety and reactogenicity of canarypox ALVAC-HIV (vCP1521) and HIV-1 gp120 AIDSVAX B/E vaccination in an efficacy trial in Thailand.

BACKGROUND: A prime-boost vaccination regimen with ALVAC-HIV (vCP1521) administered intramuscularly at 0, 4, 12, and 24 weeks and gp120 AIDSVAX B/E at 12 and 24 weeks demonstrated modest efficacy of 31.2% for prevention of HIV acquisition in HIV-uninfected adults participating in a community-based efficacy trial in Thailand. METHODOLOGY/PRINCIPAL FINDINGS: Reactogenicity was recorded for 3 days following vaccination. Adverse events were monitored every 6 months for 3.5 years, during which pregnancy outcomes were recorded. Of the 16,402 volunteers, 69% of the participants reported an adverse event any time after the first dose. Only 32.9% experienced an AE within 30 days following any vaccination. Overall adverse event rates and attribution of relatedness did not differ between groups. The frequency of serious adverse events was similar in vaccine (14.3%) and placebo (14.9%) recipients (p = 0.33). None of the 160 deaths (85 in vaccine and 75 in placebo recipients, p = 0.43) was assessed as related to vaccine. The most common cause of death was trauma or traffic accident. Approximately 30% of female participants reported a pregnancy during the study. Abnormal pregnancy outcomes were experienced in 17.1% of vaccine and 14.6% (p = 0.13) of placebo recipients. When the conception occurred within 3 months (estimated) of a vaccination, the majority of these abnormal outcomes were spontaneous or elective abortions among 22.2% and 15.3% of vaccine and placebo pregnant recipients, respectively (p = 0.08). Local reactions occurred in 88.0% of vaccine and 61.0% of placebo recipients (p<0.001) and were more frequent after ALVAC-HIV than AIDSVAX B/E vaccination. Systemic reactions were more frequent in vaccine than placebo recipients (77.2% vs. 59.8%, p<0.001). Local and systemic reactions were mostly mild to moderate, resolving within 3 days. CONCLUSIONS/SIGNIFICANCE: The ALVAC-HIV and AIDSVAX B/E vaccine regimen was found to be safe, well tolerated and suitable for potential large-scale use in Thailand. TRIAL REGISTRATION: ClinicalTrials.govNCT00223080.

Testing of Bob Calf Fecal Swabs for the Presence of Escherichia coli O157:H7.

Rectal swabs were collected from 304 Bob calves (calves under 10 d old) brought to slaughter in the States of Washington (77 swabs), California (127 swabs), and Wisconsin (100 swabs). The swab samples were tested for the presence of Escherichia coli O157:H7 by the use of a direct smear method, enrichment method, and the use of the Petrifilm™ Test Kit-HEC-for hemorrhagic E. coli O157:H7 (3M Company, St. Paul, MN). The organism was not isolated from any of the samples by any method, though the 3M test kit did give 21 positive signals. Of these positive signals, three were shown to be caused by sorbitol-positive, O157-positive, H7-negative E. coli . The cause of the other 18 signals was not determined.

Recovery of Campylobacter jejuni from Fresh and Frozen Meat and Poultry Collected at Slaughter.

Approximately 800 fresh and frozen meat and poultry samples collected at the point of slaughter were analyzed for Campylobacter jejuni . C. jejuni and C. coli isolates were never discriminated. Isolation levels of C. jejuni from fresh tissues were 5-fold higher (12.1%) than those from frozen tissues (2.3%). The prevalence of C. jejuni in fresh tissues was also higher when results were compared by animal species rather than by individual tissues.

The natural history of HIV-1 infection in young Thai men after seroconversion.

The natural history and progression of HIV-1 infection in Thailand and other developing countries in Asia and Africa have not been well defined. Nevertheless, valid data are needed to evaluate the effects of interventions, which are designed to delay progression. We evaluated the progression to AIDS and death in 235 men who seroconverted during their 2 years of service in the Royal Thai Army. The men were conscripted at age 21 and seroconverted within a 6-month window during follow-up while in the military. The seroconverters were matched with men who were seronegative when discharged. Of the HIV-positive men, 156 (66.4%) were alive, 77 (32.8%) had died, and 2 (0.8%) could not be located 5-7 years after their seroconversion and discharge from the military. The 5-year survival rate was 82.3%; the median times to clinical AIDS and a CD4 cell count of <200/microL was 7.4 years and 6.9 years, respectively. The mortality rate was 56.3 deaths per 1000 patient-years for HIV-positive men and 6.1 deaths per 1000 patient-years for HIV-negative men. Our data suggest a more rapid progression to AIDS and death after HIV-1 infection in young men in Thailand than has been reported for similarly aged cohorts in developed countries.

Long-term memory B-cell responses in recipients of candidate human immunodeficiency virus type 1 vaccines.

The efficacy and practical application of human immunodeficiency virus type 1 (HIV-1) vaccines may depend in part on the longevity of the immune responses generated, particularly those in the memory compartment. Candidate vaccines based on the HIV-1 envelope glycoproteins generate binding and neutralizing antibodies in humans but there have been no prior studies on the long-term persistence and recall of those responses. We evaluated six healthy, HIV non-infected adults who had received a combination of recombinant canarypox HIV-1 vaccines boosted by gp120 and who had achieved a high serum titer of neutralizing antibody to HIV-1 MN. These individuals were administered a gp160 boost 4-5 years after their last vaccination. Four volunteers had detectable binding and neutralizing antibodies at the time of boosting and all six volunteers exhibited a recall binding and neutralizing antibody response. The antibodies neutralized multiple T cell line-adapted (TCLA) strains of virus, including the vaccine strain, but not primary isolates. These results demonstrate that memory B-cell responses can last for many years following HIV-1 envelope glycoprotein immunization. In principle, similar long-term memory may be possible with improved immunogens that generate broadly cross-reactive neutralizing antibodies.

Safety and immunogenicity of combinations of recombinant subtype E and B human immunodeficiency virus type 1 envelope glycoprotein 120 vaccines in healthy Thai adults.

Safety and immunogenicity of 2 recombinant human immunodeficiency virus (HIV) type 1 envelope glycoprotein (gp) 120 vaccines derived from SF2 (subtype B) and CM235 (CRF01_AE, Thai E) were evaluated in 370 Thai adults at low risk of HIV infection. Various doses of CM235 (25, 50, or 100 microg) and SF2 (0, 25, or 50 microg) gp120 were used. Eighty volunteers received placebo. There were no serious adverse events related to vaccination. Binding antibody developed in all vaccine recipients. There was no dose response to CM235 gp120, but a dose response to gp120 SF2 was present. Neutralizing antibodies to subtype E HIV-1 NPO3 and subtype B HIV-1 SF2 developed in 84% and 82% of vaccine recipients, respectively. Lymphoproliferative responses were detected in >95% of vaccine recipients. There was no evidence of antigenic interference in HIV-specific humoral or cellular responses. The gp120 Thai E and SF2 vaccines were safe and immunogenic in combination and could be advanced into phase 3 testing.

Recruiting volunteers for a multisite phase I/II HIV preventive vaccine trial in Thailand.

Factors believed to be predictive of retention through the recruitment and screening processes for preventive HIV trials were investigated in a large multisite phase I/II HIV vaccine trial in Thailand. Retention through recruitment was equal to or greater than in previous smaller trials with similar populations. The data suggested that recruitment proceeded in a stepwise manner with different influences at each step. Demographic and motivational variables were most important in predicting retention in making and keeping screening appointments. Altruistic or mixed altruistic and nonaltruistic motives were associated with greater retention. Laboratory/medical variables appeared to be the main influence on retention during screening, although some volunteers withdrew for different reasons. The frequent presence of mixed (altruistic and nonaltruistic) motives at initial contact suggests that motivation for trials is more complex than has been previously acknowledged.