Adherence to Daily Oral TDF/FTC for PrEP in Community Health Center Populations: The Sustainable Health Center Implementation PrEP Pilot (SHIPP) Study.

The prevention effectiveness of oral preexposure prophylaxis (PrEP) is highly dependent on medication adherence but no validated longer term PrEP adherence measures are readily available for use by primary care clinicians caring for diverse populations. We compared two self-report measures (number of doses missed in past 7 days and day-by-day past week pill taking) to results of tenofovir concentrations in dried blood spot (DBS) samples at quarterly visits over the first 12 months of PrEP use. 1420 men and women in five US community health centers enrolled in a medication adherence substudy. For 3, 6, 9 and 12 months, the respective percentages of persons with self-report vs DBS levels consistent having taken all 7 doses in the week prior were 71% (51%), 70% (47%), 71% (46%) and 69% (44%). Conversely, the percentage of participants reporting taking 0-1 doses in the week prior by self-report vs DBS drug levels at 3, 6, 9 and 12 months consistent with this level of nonadherence of 6% (9%), 5% (10%), 8% (9%), and 9% (15%). The estimated risk of low adherence (estimated 0-1 doses in the week prior) was higher for participants of Black (RR 1.60, CI 1.09-2.34) or "Other" race (RR 1.62, CI 0.99-2.65) compared with participants of White race; being a transgender female (RR 2.31, CI 1.33-4.02) compared to men who have sex with men; or enrollment at a study site with less experience in the provision of PrEP. The estimated risk of low adherence by DBS was lower for participants with a higher number of sex partners in the past 3 months and those having a bachelor's degree or higher. More work is needed to provide clinicians with measures to assess medication adherence in diverse US populations being prescribed PrEP to support its effective use in reducing HIV acquisition in individuals and at the community level.

Dynamic social support networks of younger black men who have sex with men with new HIV infection.

Rising rates of HIV infection among younger black men who have sex with men (YBMSM) in the USA have generated a public health emergency. Living with HIV requires deep and persistent social support often available only from close confidants. Enlisting endogenous support network members into the care of HIV-infected YBMSM may help shape sustainable supportive environments, leading to long-term improvements in mental and HIV-specific health outcomes. The present study examined trends in support network change over time after new HIV diagnoses among 14 YBMSM. Participants completed a social network survey that utilized sociograms to record support confidants (SCs) preceding HIV diagnosis and at one and nine months postdiagnosis. Reported SCs included family of origin, friends, sex partners, and other associates. Analysis revealed three distinct patterns of change: high gain, high turnover, and stable networks. These patterns offer valuable insights into the social support of YBMSM during the period following diagnosis. This research underscores a growing movement to embrace key support figures in the lives of YBMSM, who may be critical to promoting overall health and adherence to HIV-care.

Factors associated with publication following presentation at a transplantation meeting.

Full publication of abstracts presented at scientific meetings ranges from 25-74%. To determine the rate and factors associated with publication in organ transplantation, we examined abstracts presented at the American Transplant Congress in May 2000. Of 1147 abstracts, 607 (53%) achieved full publication at 4.5 years (mean 1.32 +/- 0.88 years). Fifty-nine percent (357/607) were published in three transplantation journals. For randomized trials, the proportion published was 61%. On multivariate analysis, industry sponsorship (OR 1.78; 95% CI 1.04-3.06), basic science research (OR 1.68; 95% CI 1.32-2.14), non-American center (OR 1.67; 95% CI 1.28-2.20) and oral presentation (OR 1.36; 95% CI 1.07-1.73) were independent predictors of full publication. Nearly half of all abstracts presented at a transplantation meeting remain unpublished. This finding needs to be considered when interpreting systematic reviews in the field of transplantation.

Risk factors for antibiotic-resistant infection and treatment outcomes among hospitalized patients transferred from long-term care facilities: does antimicrobial choice make a difference?

A prospective observational study of 153 patients transferred from long-term care facilities and admitted to acute-care hospitals who had microbiologically confirmed infections was undertaken to determine the risk factors, outcomes, and resource use associated with isolation of antibiotic-resistant bacteria (ARB). Eighty patients (52%) were infected with ARB. In multivariable logistic analysis, the presence of a feeding tube (odds ratio, 3.0) or polymicrobial infection (odds ratio, 4.6) was associated with isolation of ARB. Forty-nine percent of patients infected with ARB received an initial antibiotic regimen to which their isolate was not susceptible. Fifty-one percent of all patients had a change in their antibiotic regimen during their hospital course. For these patients, length of stay, number of days of antibiotic therapy, and cost of hospitalization were significantly higher. However, neither infection with ARB nor appropriateness of initial treatment regimen was significantly related to outcome or resource use.

Animated-simulation modeling facilitates clinical-process costing.

Traditionally, the finance department has assumed responsibility for assessing process costs in healthcare organizations. To enhance process-improvement efforts, however, many healthcare providers need to include clinical staff in process cost analysis. Although clinical staff often use electronic spreadsheets to model the cost of specific processes, PC-based animated-simulation tools offer two major advantages over spreadsheets: they allow clinicians to interact more easily with the costing model so that it more closely represents the process being modeled, and they represent cost output as a cost range rather than as a single cost estimate, thereby providing more useful information for decision making.

Resource cost analysis of cervical spine trauma radiography.

PURPOSE: To determine the resource costs of the technical component of cervical spine radiography in patients with trauma and the factors that drive resource costs, to provide a model for resource cost estimation, and to compare resource costs with other methods of cost estimation. MATERIALS AND METHODS: Direct measurement was made of technologist labor and supply costs of a cohort of 409 consecutive patients with trauma who underwent cervical spine radiography. Probability of cervical spine injury was determined by reviewing emergency department medical records. An animated simulation model was used to combine cost and injury probability estimates to determine resource costs. Sensitivity analysis explored factors that determined costs and estimated uncertainty in model estimations. Comparison was made with other cost estimates. RESULTS: The average technical resource cost for cervical spine radiography was $49.60. Both direct labor ($19.60 vs $13.33; P <.005) and film ($8.39 vs $6.76; P <.005) costs were greater in patients with high probability of injury than in those with low probability of injury. Overall costs in patients with high probability of injury exceeded those in patients with low probability of injury by 33%. Resource costs exceeded Medicare resource-based relative value unit reimbursements for all patients with trauma. CONCLUSION: Resource costs of the technical components of cervical spine radiography varied with patient probability of injury and were higher than Medicare reimbursements.

The influence of nutrition on IGF-1 in tube-fed profoundly retarded adults.

OBJECTIVE: This study was conducted to determine whether IGF-I concentrations are low in nonambulant profoundly retarded adults and to identify associated nutritional factors. METHODS: Serum IGF-I, albumin, pre-albumin, creatinine, zinc (Zn) and plasma amino acids were measured before and after a four-week 25% increase in formula in 25 individuals, divided into those fed by day (Group A) or by night (Group B). RESULTS: Circulating IGF-I was low in nine of the 22 subjects (40.9%) included in the analysis. Mean IGF-I increased 10.4% (p=0.004). Despite high intakes of essential amino acids and Zn, initial mean plasma tryptophan and phenylalanine were low, and serum Zn was low in 40.9% of subjects. Plasma tryptophan was low at both samplings and correlated with circulating IGF-I concentrations (p=0.02) at the beginning of the study. Serum IGF-I and Zn also correlated (p=0.02) initially. CONCLUSIONS: IGF-I is commonly low in this population and is associated with low plasma amino acid and Zn concentrations, despite high intakes of these nutrients. The causes and clinical implications of these abnormalities need further study.

Extending simulation modeling to activity-based costing for clinical procedures.

A simulation model was developed to measure costs in an Emergency Department setting for patients presenting with possible cervical-spine injury who needed radiological imaging. Simulation, a tool widely used to account for process variability but typically focused on utilization and throughput analysis, is being introduced here as a realistic means to perform an activity-based-costing (ABC) analysis, because traditional ABC methods have difficulty coping with process variation in healthcare. Though the study model has a very specific application, it can be generalized to other settings simply by changing the input parameters. In essence, simulation was found to be an accurate and viable means to conduct an ABC analysis; in fact, the output provides more complete information than could be achieved through other conventional analyses, which gives management more leverage with which to negotiate contractual reimbursements.

Age, gender, dentures and oral mucosal disorders.

The numbers of participants over 75 years of age in previous studies of oral health have not been sufficient to permit a full investigation of the influence of age on the mouth. In this study a disproportionate stratified random sample of 255 independent elders was selected from a list of urban voters to provide similar numbers of men and women in three age groups. The subjects were interviewed and examined, and nearly half of them had mucosal disorders. There was a significant (P < 0.05) association between mucosal lesions and the use of dentures and tobacco, whereas stomatitis, denture-related hyperplasia and angular cheilitis in particular were associated significantly with men and with the use of defective dentures. Logistic regression revealed that neither age alone nor the quality of dentures predispose to mucosal lesions, but that the odds of finding stomatitis, denture-related hyperplasia and angular cheilitis in particular increased about three-fold in denture-users, and almost doubled in men.

A prospective study of heart rate response following trauma and the subsequent development of posttraumatic stress disorder.

BACKGROUND: Physiological arousal during traumatic events may trigger the neurobiological processes that lead to posttraumatic stress disorder (PTSD). This study prospectively examined the relationship between heart rate and blood pressure recorded immediately following a traumatic event and the subsequent development of PTSD. METHODS: Eighty-six trauma survivors who presented at the emergency department of a general hospital were followed up for 4 months. Heart rate and blood pressure were recorded on arrival at the emergency department. Heart rate, anxiety, depression, and PTSD symptoms were assessed 1 week, 1 month, and 4 months later. The clinician-administered PTSD scale defined PTSD status at 4 months. RESULTS: twenty subjects (23%) met PTSD diagnostic criteria at the 4-month assessment (PTSD group), and 66 (77%) did not (non-PTSD group). Subjects who developed PTSD had higher heart rates at the emergency department (95.5+/-13.9 vs 83.3+/-10.9 beats per minute, t=4.4, P<.001) and 1 week later (77.8+/-11.9 vs 72.0+/-9.5 beats per minute, t=2.25, P<.03), but not after 1 and 4 months. The groups did not differ in initial blood pressure measurement. Repeated-measures analysis of variance (ANOVA) for heart rate showed a significant group effect (P<.02), time effect (P<.001), and group x time interaction (P<.001). The time effect and group x time interaction remained significant when adjusted for sex, age, trauma severity, immediate response, and dissociation during the traumatic event. CONCLUSION: Elevated heart rate shortly after trauma is associated with the later development of PTSD.

A potent activator of HIV-1 replication is present in the genital tract of a subset of HIV-1-infected and uninfected women.

OBJECTIVE AND DESIGN: To determine whether the female genital tract contains factors that affect HIV-1 replication. Cervicovaginal lavage (CVL) samples were collected from HIV-1-seropositive and seronegative women and added to cell cultures. METHODS: HIV p24 production was used to measure the effects of CVL on replication of HIVMN in a T-cell line, of a primary isolate in peripheral blood mononuclear cells, or on HIV expression by the latently-infected monocytic U1 cell line. The effects of CVL on the HIV long terminal repeat (LTR) were determined in 1G5 T cells by measuring luciferase activity. RESULTS: Increased replication of HIVMN and a primary isolate were observed in T cells cultured with CVL samples from three out of 38 HIV-infected women, one out of four uninfected high-risk women, and none of 12 low-risk women. The CVL factor increased replication by enhancing virus expression via activation of the HIV LTR. The HIV-inducing activity was highly stable to heat but was sensitive to proteases, indicating that the activity was distinct from heat-labile cytokines including tumour necrosis factor-alpha. CONCLUSIONS: This is the first study to show that a factor which can stimulate HIV-1 replication is present at biologically active levels in the reproductive tract of women. This factor could potentially affect sexual or vertical transmission of HIV-1 by altering genital tract virus load or virus expression.

An outcomes assessment of a hybrid-PBL course in treatment planning.

As part of an ongoing process of curriculum development, a new course was developed at the University of British Columbia (UBC) to address problems such as lack of student enjoyment of the learning process, poor student preparedness for clinical treatment planning, and underdeveloped critical thinking skills in students beginning their clinical experience. The new course utilized a hybrid problem-based learning (PBL) format that provided students with an overview in lecture format while encouraging active learning in small group tutorials and seminars. Half the second-year class was randomly selected to participate in the new course, while the other half received the standard lectures on the subject. An outcomes assessment examined whether the aforementioned problems had been addressed in the new course. Course participants completed a post-course evaluation, and all students completed a self-assessment of their preparedness and progress in treatment planning and diagnostic. Clinical instructors, who were blind to the identity of the new course participants, were asked to independently assess each student using the same criteria. Results indicate that students who participated in the hybrid-PBL course enjoyed the learning process and later rated themselves as being better prepared and improving more in the areas of treatment planning and diagnostic records than their counterparts, although the latter results were not routinely statistically significant (p < 0.1). Instructor evaluations supported these differences between the two groups.

Apical root strain as a function of post extension into a composite resin core.

This study tested the hypothesis that there is no difference in the amount of strain measured in the root of an extracted tooth at the apical end of a prefabricated post, whether a composite resin core completely covers the head of the post or the post is exposed at the occlusal surface of the core. Twenty extracted teeth were measured (1) after endodontic treatment (baseline), (2) after a composite resin core was fabricated over a prefabricated post, and (3) after a cast crown was cemented. The teeth were randomly divided into two groups after baseline testing. In group 1, the post was buried within the core, and in group 2, the head of the post was exposed on the occlusal surface of the core. Analysis of results indicated a statistically significant decrease in strain from the baseline to the crown when 1 mm of composite resin covered the head of the post. However, based on the small strain values measured, the difference may not be clinically significant.

Midazolam following open heart surgery in children: haemodynamic effects of a loading dose.

Our objective was to establish the safety and effectiveness of a loading dose of midazolam for postoperative sedation of children recovering from open heart surgery; a prospective randomized placebo-controlled double-blind study was done with subjects randomized to three groups according to loading dose. I = 0.08 mg.kg-1; II = 0.04 mg.kg-1; and III = 0.00 mg.kg-1 (placebo). An open label continuous midazolam infusion protocol followed. Haemodynamic parameters were monitored. The study was discontinued following an adverse event involving the 23rd subject. When data for all 23 subjects were combined, there was a mean decrease of 10% in blood pressure (BP) 30 min after the loading dose (P < 0.001). Heart rate change was less significant. Clinicians identified four hypotensive episodes as temporally associated with the midazolam load, two each in Groups I (0.08 mg.kg-1) and III (placebo). One subject in Group I (the 23rd) became hypotensive within five min of receiving the loading dose, had a difficult clinical course and died four weeks postoperatively. We cannot conclude that the loading dose of midazolam had any systematic haemodynamic effect in our study population. Although the clinical course of the 23rd subject suggests a subset of more susceptible children (those who receive opioid analgesia with midazolam, are volume-restricted, and/or undergo more complex forms of surgical correction), many critical care patients are inherently physiologically unstable, and concluding clinically that blood pressure fluctuation is drug related may be erroneous.

The Vancouver sedative recovery scale for children: validation and reliability of scoring based on videotaped instruction.

We originally developed and tested the Vancouver Sedative Recovery Scale (VSRS) to measure recovery from sedation following paediatric open heart surgery and reported excellent clinical inter-observer reliability. We now report a new study using videotape instruction of novice raters and videotaped case examples to determine whether the instruction produces adequate skill with the VSRS. Inter-rater reliability was assessed using videotapes of 16 children across a range of ages (six months to six years), and all levels of sedation (unresponsive to fully awake). Variably randomized subsets of six of the 16 test cases were randomly assigned to be rated by each of 16 video-instructed ICU staff volunteers, according to a balanced incomplete block design, such that every pair of raters assessed two children in common. The validity of the ratings from the video-instructed raters was assessed by comparison with "gold standard" scores from two experts who rated all 16 children clinically as the test cases were videotaped. The experts were in agreement themselves (intraclass correlation of 0.976). The correlation between the novice scores (average of six ratings per video) and the live clinical scores (average of two expert ratings) was 0.977 over the 16 test cases. On average, the mean expert rating was slightly higher, but the difference was negligible. (The differences between the mean ratings of the experts and novices for 13 of the 16 videos are very close to zero, while the other three differences, from technically less good videos, are two standard deviations away from zero). The VSRS, video instruction method and incomplete block design may be of use to other clinicians and investigators.

Predictors of caries in old age.

This study measured the incidence of dental caries for one year and identified factors associated with the risk of caries in a sample of 156 elderly subjects. The subjects were examined at baseline and after one year to record the number of missing, filled and decayed teeth, to measure oral hygiene and flow of saliva, and to estimate the numbers of Streptococcus mutans and Lactobacilli cultured from samples of saliva. All subjects were interviewed on both occasions for information on their use of medications and dental services and on their ingestion of sugar. At baseline the elders had a mean of 19 natural teeth with 5 decayed surfaces (DS), 38 filled surfaces and a mean Plaque Index (PI) of 1. The independent group, on average, had more teeth and fillings but a lower PI and less caries. At the end of the year more than two-thirds (71%) of the 98 institutionalised subjects and over half (59%) of the 58 independent subjects had at least one new decayed/filled surface (DFS). The mean net DFS increment per subject was 4.6 and 2.0 respectively. Regression analyses on multivariate models identified caries at baseline, residence in long term care facilities, high numbers of Lactobacilli, poor oral hygiene and frequent sugar consumption as the variables contributing most significantly to the risk of caries in old age.

A comparison of regularly dosed oral morphine and on-demand intramuscular morphine in the treatment of postsurgical pain.

A randomized, placebo-controlled, double-blind clinical trial was conducted to compare the use of regularly dosed po morphine and on-demand in morphine in 47 patients undergoing total hip arthroplasty. Patients were randomized to receive either 20 mg (initial dose) of regularly dosed morphine (every four hours po) plus breakthrough pain medication on-demand consisting of both 10 mg morphine po and placebo im, or an equivalent regularly dosed oral placebo (every four hours) with breakthrough pain medication consisting of oral placebo and 5-10 mg morphine im. Subsequent to each request for breakthrough pain medication, the next regularly dosed oral solution was increased by 5 mg (or equivalent volume of placebo) to a maximum of 40 mg po Q4H. Time-averaged pain scores were lower on both postoperative day 1 and 2 in the group receiving regularly dosed morphine po (P < 0.05). Fewer patients requested breakthrough pain medication on both days in the oral morphine group. The incidence of nausea and vomiting, and of decreased respiratory rates were similar in both groups. Regularly dosed oral morphine is inexpensive and should be compared to other methods of opioid delivery.

Influence of age and gender on oral health and related behaviour in an independent elderly population.

Previous studies have been unable to determine the influence of advanced age on oral health because they included relatively few subjects, particularly men, over 75 yr of age. In this study a disproportionate and stratified random sample of subjects over 70 yr and living independently was selected from a list of voters in Vancouver, B.C. The sample of 521 elders was structured to provide similar numbers of men and women in three 5-yr age-groups. All of the subjects were interviewed, and 255 of them, representing a similar distribution of age and gender, were examined to investigate the influence of aging on oral health and related behaviour. In bivariate analyses neither age nor gender was associated significantly with oral health or complaints. The use of dental services during the preceding year was associated with female and younger subjects, while men and older subjects usually went to dentists only to relieve pain. Logistic regression in a multivariate model confirmed the importance of natural teeth in predicting the use of dental services (by improving the prediction from 60% to 73%). Other models offered less useful improvements in predicting complaints (64% to 70%) or oral health (56% to 60%). Overall the study demonstrates that the age and gender of independent elders have very little direct influence on the oral health or related behaviour established early in life.

A research tool for measurement of recovery from sedation: the Vancouver Sedative Recovery Scale.

The need for a research tool to measure recovery from sedation was identified during the design phase of a study investigating sedative protocols following open heart surgery in children. A thorough review of the literature failed to show any scales that measure degree of sedation in children at various times after initial awakening. The Vancouver Sedative Recovery Scale (VSRS) was developed through an iterative process during which we identified numerous indicators of levels of alertness among sedated children, and then determined the applicability and face validity of these indicators. The VSRS evaluated in this study consists of 12 distinct items that encompass three categories of indicators (response; eye appearance and function; and body movement). Total possible VSRS scoring ranges from 0 to 22 (higher score indicating more alert) because some of the 12 items have more than two rating levels. The VSRS was administered to 82 pediatric intensive care unit and postanesthesia recovery patients, with each patient assessed simultaneously by at least two observers. Internal consistency as measured by Cronbach's alpha was excellent: 0.85. Interobserver agreement or reliability as measured by intraclass correlation was also very high: 0.90; and for individual items Cohen's kappa ranged from 0.65 to 0.89. We consider the VSRS to be a good beginning in our effort to quantify level of alertness after sedation in the pediatric patient population.

Predicting concerns for the mouth among institutionalized elders.

There is a widespread belief that old people do not have healthy mouths, although the reason for this neglect is not clear. A random sample of 41 long-term care facilities in Vancouver was selected--653 residents were examined and about three-quarters of them were interviewed--to find associations between variables that might influence a concern for oral health and to assess the effectiveness of multivariate models for predicting this concern. A bivariate analysis of the data, using chi-square tests, assessed any significant associations between the variables, and three classification techniques--discriminant analysis, logistic regression, and CART (classification and regression trees)--were used to assess the usefulness of the multivariate models. Complaints of oral problems were heard from half (53%) of the sample. Most (85%) of the participants expressed a desire for treatment, while fewer than half (44%) of the participants had used a dental service since entering the facility or in the previous year. The complaints were associated significantly with the subjects who had been to a dentist recently, with those dissatisfied with the cost or quality of previous treatment, and with women. The desire for treatment was associated significantly with the recent use of dental services, and with a lack of concern for the cost of dental treatment, while the use of services was associated significantly with subjects who were younger, dentate, or from the higher socioeconomic groups.(ABSTRACT TRUNCATED AT 250 WORDS)