FcRn Expression on Placenta and Fetal Jejunum during Early, Mid-, and Late Gestation in Minipigs.

Developmental toxicity testing of therapeutic antibodies is most often conducted in nonhuman primates owing to lack of cross-reactivity in other species. Minipigs may show cross-reactivity for some humanized antibodies but have not been used for developmental toxicity testing due to an assumed lack of embryo-fetal exposure. Unlike in humans, maternal IgGs do not cross the porcine placenta to reach the fetus. Some humanized IgGs, however, have a higher affinity for the neonatal Fc receptor (FcRn) and are more likely than endogenous antibodies to cross the placenta of animals. The major site of prenatal IgG transfer is the placenta, though FcRn in fetal intestine could also uptake maternal IgGs from swallowed amniotic fluid. Using immunohistochemistry andin situhybridization in this experiment, FcRn was found in minipig placenta and fetal intestine during early, mid-, and late gestation. To date, however, fetal exposure to maternally administered IgGs has never been demonstrated in the minipig.

Fortified breakfast cereal consumed daily for 12 wk leads to a significant improvement in micronutrient intake and micronutrient status in adolescent girls: a randomised controlled trial.

BACKGROUND: Poor micronutrient status is reported among adolescents across Europe and USA. This may be related to the well-documented decline in the regular consumption of breakfast by this group. The regular consumption of a breakfast cereal offers a possible means to improve micronutrient status; fortified cereal is likely to have enhanced benefit. A study was conducted to determine the efficacy of the regular consumption of a fortified cereal with milk, compared with unfortified cereal, consumed either as a breakfast or a supper, in improving micronutrient intake and micronutrient status of adolescent girls. METHODS: A randomised, double-blind, placebo-controlled intervention trial was conducted in girls recruited at ages 16-19 years, from schools and colleges in Sheffield, UK. Girls were randomised to receive 50 g fortified or unfortified cereal, with 150 ml semi-skimmed milk, daily, for 12 weeks, as a breakfast or as a supper. Dietary intake was estimated using a 4-d food diary and blood collected for the assessment of nutritional status. Within-group changes were tested using a paired sample t test; two-way ANOVA was used to analyse effects of the intervention, with cereal type and time of consumption as factors, correcting for baseline values. The analysis was conducted on 71 girls who completed the study. RESULTS: Consumption of unfortified cereal elicited an increase in the intake of vitamins B1, B2 and B6; consumption of fortified cereal elicited increases in vitamins B1, B2, B6, B12, folate and iron (P < 0.001) and of vitamin D (P = 0.007), all increases were significantly greater than for unfortified cereal. Consumption of the fortified cereal also led to a significant improvement in biomarkers of status for vitamins B2, B12, folate and of iron, compared with girls receiving the unfortified cereal, and maintained vitamin D status, in contrast with the girls receiving the unfortified cereal (P < 0.001). CONCLUSIONS: The daily consumption of cereal with milk for 12 weeks by adolescent girls, increased intakes of micronutrients. The consumption of fortified cereal elicited greater increases than for unfortified cereal and improved biomarkers of micronutrient status. The findings justify strategies to encourage the consumption of fortified cereal with milk by adolescents, either as a breakfast or a supper. TRIAL REGISTRATION: Registered with Current Controlled Trials (Registration: ISRCTN55141306 ).

Recommendations from a global cross-company data sharing initiative on the incorporation of recovery phase animals in safety assessment studies to support first-in-human clinical trials.

An international expert group which includes 30 organisations (pharmaceutical companies, contract research organisations, academic institutions and regulatory bodies) has shared data on the use of recovery animals in the assessment of pharmaceutical safety for early development. These data have been used as an evidence-base to make recommendations on the inclusion of recovery animals in toxicology studies to achieve scientific objectives, while reducing animal use. Recovery animals are used in pharmaceutical development to provide information on the potential for a toxic effect to translate into long-term human risk. They are included on toxicology studies to assess whether effects observed during dosing persist or reverse once treatment ends. The group devised a questionnaire to collect information on the use of recovery animals in general regulatory toxicology studies to support first-in-human studies. Questions focused on study design, the rationale behind inclusion or exclusion and the impact this had on internal and regulatory decisions. Data on 137 compounds (including 53 biologicals and 78 small molecules) from 259 studies showed wide variation in where, when and why recovery animals were included. An analysis of individual study and programme design shows that there are opportunities to reduce the use of recovery animals without impacting drug development.

A vitamin B-12 supplement of 500 µg/d for eight weeks does not normalize urinary methylmalonic acid or other biomarkers of vitamin B-12 status in elderly people with moderately poor vitamin B-12 status.

Plasma vitamin B-12 is the most commonly used biomarker of vitamin B-12 status, but the predictive value for low vitamin B-12 status is poor. The urinary methylmalonic acid (uMMA) concentration has potential as a functional biomarker of vitamin B-12 status, but the response to supplemental vitamin B-12 is uncertain. A study was conducted to investigate the responsiveness of uMMA to supplemental vitamin B-12 in comparison with other biomarkers of vitamin B-12 status [plasma vitamin B-12, serum holotranscobalamin (holoTC), plasma MMA] in elderly people with moderately poor vitamin B-12 status. A double-blind, placebo-controlled, randomized 8-wk intervention study was carried out using vitamin B-12 supplements (500 µg/d, 100 µg/d, and 10 µg/d cyanocobalamin) in 100 elderly people with a combined plasma vitamin B-12 <250 pmol/L and uMMA ratio (µmol MMA/mmol creatinine) >1.5. All biomarkers had a dose response to supplemental vitamin B-12. Improvements in plasma vitamin B-12 and serum holoTC were achieved at cobalamin supplements of 10 µg/d, but even 500 µg/d for 8 wk did not normalize plasma vitamin B-12 in 8% and serum holoTC in 12% of people. The response in uMMA was comparable with plasma MMA; 15-25% of people still showed evidence of metabolic deficiency after 500 µg/d cobalamin for 8 wk. There was a differential response in urinary and plasma MMA according to smoking behavior; the response was enhanced in ex-smokers compared with never-smokers. uMMA offers an alternative marker of metabolic vitamin-B12 status, obviating the need for blood sampling.

Systemic folate status, rectal mucosal folate concentration and dietary intake in patients at differential risk of bowel cancer (The FAB2 Study).

BACKGROUND/OBJECTIVES: Folate has been strongly implicated in the aetiology of colorectal cancer. However, the relationship between dietary folate intake, rectal mucosal folate status and colorectal cancer risk is uncertain. The study aimed to estimate nutrient intakes and measure systemic folate status and rectal mucosal folate concentration in people at differential risk of developing colorectal cancer. METHODS: Two hundred and twenty-eight individuals were recruited from gastroenterology clinics and subdivided into three patient groups: untreated colorectal cancer (n = 43), adenomatous polyps (n = 90) or normal bowel (n = 95). Biopsies from macroscopically normal rectal mucosa and blood were collected and used for the measurement of rectal mucosal 5-methyltetrahydrofolate (5-MeTHF) and systemic markers of folate status, respectively. Nutrient intake was estimated using a validated food frequency questionnaire. RESULTS: Dietary intake variables, plasma 5-MeTHF and red cell folate and plasma homocysteine concentrations were similar in all three subject groups and 95% CI fell within normal range for each variable. Rectal mucosal 5-MeTHF concentration was higher in the normal mucosa of adenomatous polyp patients than in normal subjects (P = 0.055). Rectal mucosal 5-MeTHF was associated significantly with plasma folate (P < 0.001, r = 0.294), red cell folate (P = 0.014, r = 0.305), plasma homocysteine (P = 0.017, r = -0.163) and dietary folate intake (P = 0.036, r = 0.152). CONCLUSIONS: This study demonstrates adequate folate status of patients attending gastroenterology clinics for the investigation of bowel symptoms, with no significant difference in dietary intakes or systemic folate status indices according to diagnosis. Rectal mucosal 5-MeTHF concentrations were elevated in adenomatous polyp patients, but failed to reach significance. Further studies are required to determine the biological significance of this observation.

"Simulect" as a model compound for assessing placental transfer of monoclonal antibodies in minipigs.

The aim of this study was to directly test and measure in vivo, if placental transfer of monoclonal antibodies takes place in pregnant Göttingen Minipigs to assess their suitability for reproductive assessment of therapeutic monoclonal antibodies. Simulect®, an approved anti CD25 (anti IL-2 receptor alpha) chimeric monoclonal IgG1 antibody, was used as a model monoclonal antibody. Maternal systemic exposure and potential placental transfer of Simulect® to fetuses were investigated following 4 weekly bolus intravenous administration of 5.0 mg/kg from gestation day (GD) 79 or 80 (e.g GD 79, 86, 93 and 100) and with terminal Caesarean section on GD 108 or GD 109 respectively. Results clearly showed exposure in maternal animals, detectable compound in the amniotic fluid from one out of 9 maternal animals, but no exposure in fetuses confirming absence of placental transfer of the selected model antibody Simulect® in minipigs. The absence of Simulect® in the fetuses further supports that the presence of Simulect® in the amniotic fluid in one maternal animal was likely due to contamination with maternal blood during sampling. The demonstrated absence of fetal exposure clearly indicates that, the minipig is not a suitable species for conduct of reproductive toxicity studies with monoclonal antibodies.

Effects of methodological variation on assessment of riboflavin status using the erythrocyte glutathione reductase activation coefficient assay.

Riboflavin status is usually measured as the in vitro stimulation with flavin adenine dinucleotide of the erythrocyte enzyme glutathione reductase, and expressed as an erythrocyte glutathione reductase activation coefficient (EGRAC). This method is used for the National Diet and Nutrition Surveys (NDNS) of the UK. In the period between the 1990 and 2003 surveys of UK adults, the estimated prevalence of riboflavin deficiency, expressed as an EGRAC value > or = 1.30, increased from 2 to 46 % in males and from 1 to 34 % in females. We hypothesised that subtle but important differences in the detail of the methodology between the two NDNS accounted for this difference. We carried out an evaluation of the performance of the methods used in the two NDNS and compared against an 'in-house' method, using blood samples collected from a riboflavin intervention study. Results indicated that the method used for the 1990 NDNS gave a significantly lower mean EGRAC value than both the 2003 NDNS method and the 'in-house' method (P < 0.0001). The key differences between the methods relate to the concentration of FAD used in the assay and the duration of the period of incubation of FAD with enzyme. The details of the EGRAC method should be standardised for use in different laboratories and over time. Additionally, it is proposed that consideration be given to re-evaluating the basis of the EGRAC threshold for riboflavin deficiency.

Study Protocol: randomised controlled trial to investigate the functional significance of marginal riboflavin status in young women in the UK (RIBOFEM).

BACKGROUND: The functional significance of moderate riboflavin deficiency as it is currently assessed is not well understood. Animal and human studies have suggested a role for riboflavin in the absorption and mobilisation of iron and as such may be important in maintaining haematological status. Recent National Diet and Nutrition Surveys in the United Kingdom have shown that young women in particular are at risk of moderate riboflavin deficiency and low iron status. METHODS/DESIGN: A randomised placebo controlled intervention trial was conducted to investigate the effect of riboflavin supplementation on various measures of haematological status in a group of moderately riboflavin deficient young women aged 19 to 25 years. Women who were low milk consumers were initially screened for riboflavin status as assessed by the erythrocyte glutathione reductase activation coefficient assay (EGRAC). One hundred and twenty three women with EGRAC values >1.40 were randomised to receive 2 mg, 4 mg riboflavin or placebo for 8 weeks. In addition 36 of these women were randomly allocated to an iron bioavailability study to investigate the effect of the intervention on the absorption or utilisation of iron using an established red cell incorporation technique. DISCUSSION: One hundred and nineteen women completed the intervention study, of whom 36 completed the bioavailability arm. Compliance was 96 +/- 6% (mean +/- SD). The most effective recruitment strategy for this gender and age group was e-communication (e-mail and website). The results of this study will clarify the functional significance of the current biochemical deficiency threshold for riboflavin status and will inform a re-evaluation of this biochemical threshold. TRIAL REGISTRATION: Current Controlled Trials Registration No. ISRCTN35811298.

Responses of biomarkers of folate and riboflavin status to folate and riboflavin supplementation in healthy and colorectal polyp patients (the FAB2 Study).

Epidemiologic data suggest that increasing folate intake may protect against colorectal cancer. Riboflavin may interact with folate to modulate the effect. A double-blind randomized placebo-controlled intervention study (the FAB2 Study) was carried out in healthy controls and patients with colorectal polyps (adenomatous and hyperplastic) to examine effects of folic acid and riboflavin supplements on biomarkers of nutrient status and on putative biomarkers of colorectal cancer risk (DNA methylation and DNA damage; to be reported elsewhere). Ninety-eight healthy controls and 106 patients with colorectal polyps were stratified for the thermolabile variant of methylene tetrahydrofolate reductase, MTHFR C677T, and were randomized to receive 400 microg of folic acid, 1,200 microg of folic acid, or 400 microg of folic acid plus 5 mg of riboflavin or placebo for 6 to 8 weeks. Blood samples and colon biopsy samples were collected for the measurement of biomarkers of folate and riboflavin status. Supplementation with folic acid elicited a significant increase in mucosal 5-methyl tetrahydrofolate, and a marked increase in RBC and plasma, with a dose-response. Measures of riboflavin status improved in response to riboflavin supplementation. Riboflavin supplement enhanced the response to low-dose folate in people carrying at least one T allele and having polyps. The magnitude of the response in mucosal folate was positively related to the increase in plasma 5-methyl tetrahydrofolate but was not different between the healthy group and polyp patients. Colorectal mucosal folate concentration responds to folic acid supplementation to an extent comparable to that seen in plasma, but with a suggestion of an upper limit.

Feasibility of intravitreal injections and ophthalmic safety assessment in marmoset (Callithrix jacchus) monkeys.

To safeguard patients, regulatory authorities require that new drugs that are to be given by the intravitreal (IVT) route are assessed for their safety in a laboratory species using the same route of administration. Due to the high similarity of ocular morphology and physiology between humans and nonhuman primates (NHPs) and due to the species specificity of many biotherapeutics, the monkey is often the only appropriate model. To this end, intravitreal administration and assessment of ocular toxicity are well established in cynomolgus monkeys (Macaca fascicularis). In contrast, the common marmoset monkey (Callithrix jacchus) is not a standard model for ocular toxicity studies due to its general sensitivity to laboratory investigations and small eye size. It was the purpose of the present work to study whether the marmoset is a useful alternative to the cynomolgus monkey for use in intravitreal toxicological studies. Six marmoset monkeys received repeated (every 2 weeks for a total of four doses) intravitreal injections of 10 or 20  µ L of a placebo. The animals were assessed for measurements of intraocular pressure (IOP), standard ophthalmological investigations and electroretinography (ERG). At the end of the dosing period, the animals were sacrificed and the eyes were evaluated histologically. ERG revealed similar results when comparing predose to end-of-study data, and there was no difference between the two dose volumes. A transient increase in the IOP was seen immediately after dosing, which was more pronounced after dosing of 20  µ L compared to 10  µ L. Ophthalmologic and microscopic observations did not show any significant changes. Therefore, it can be concluded that 10  µ L as well as 20  µ L intravitreal injections of a placebo are well tolerated in the marmoset. These results demonstrate that the common marmoset is an alternative to the cynomolgus monkey for intravitreal toxicity testing.

Methyl Donor Status Influences DNMT Expression and Global DNA Methylation in Cervical Cancer Cells.

BACKGROUND: Methyl donor status influences DNA stability and DNA methylation although little is known about effects on DNA methyltransferases. The aim of this study was to determine whether methyldonor status influences DNA methyltransferase (Dnmt) gene expression in cervical cancer cells, and if so, whether there are associated effects on global DNA methylation. MATERIALS AND METHODS: The human cervical cancer cell line, C4 II, was grown in complete medium and medium depleted of folate (FM+) and folate and methionine (FM). Growth rate, intracellular folate, intracellular methionine and homocysteine in the extracellular medium were measured to validate the cancer cell model of methyl donor depletion. Dnmt expression was measured by qRT PCR using relative quantification and global DNA methylation was measured using a flow cytometric method. RESULTS: Intracellular folate and methionine concentrations were significantly reduced after growth in depleted media. Growth rate was also reduced in response to methyl donor depletion. Extracellular homocysteine was raised compared with controls, indicating disturbance to the methyl cycle. Combined folate and methionine depletion led to a significant downregulation of Dnmt3a and Dnmt3b; this was associated with an 18% reduction in global DNA methylation compared with controls. Effects of folate and methionine depletion on Dnmt3a and 3b expression were reversed by transferring depleted cells to complete medium. CONCLUSIONS: Methyl donor status can evidently influence expression of Dnmts in cervical cancer cells, which is associated with DNA global hypomethylation. Effects on Dnmt expression are reversible, suggesting reversible modulating effects of dietary methyl donor intake on gene expression, which may be relevant for cancer progression.

Effect of folic Acid supplementation on the folate status of buccal mucosa and lymphocytes.

Folate deficiency may be associated with an increased risk of cancer at certain sites. There is a need to measure folate status and putative biomarkers of cancer risk in the same target tissue, or in surrogate tissues. A study was carried out to develop a method for the rapid measurement of folate in human buccal mucosa and lymphocytes and to evaluate the responsiveness of this measurement in both tissues to folic acid supplementation in healthy subjects, relative to conventional markers of folate status. Three hundred and twenty-three adults, ages between 20 and 60 years, were screened for RBC folate concentrations. Sixty-five subjects with red cell folate between 200 and 650 nmol/L participated in a randomized, double blind, placebo-controlled, folic acid (1.2 mg) intervention trial, lasting 12 weeks. As anticipated, a significant baseline correlation (r = 0.36, P < 0.01) was observed between red cell folate and plasma 5-methyltetrahydrofolate (5-MeTHF). Lymphocyte total folate was significantly associated with plasma 5-MeTHF (r = 0.28, P < 0.05) and plasma total homocysteine concentration (r = -0.34, P < 0.05). Buccal mucosa total folate showed no correlation with either red cell folate or 5-MeTHF, but was significantly associated with lymphocyte total folate (r = 0.35, P < 0.01). Supplementation elicited a significant increase in lymphocyte total folate (P < 0.01), and this was strongly associated with the increase in RBC total folate (P < 0.01) and plasma 5-MeTHF (P < 0.01). Buccal mucosa total folate was not influenced by folate supplementation. Methods have been developed for the rapid measurement of lymphocyte and buccal mucosal total folate. Lymphocyte folate is sensitive to folate intake and is reflected by plasma 5-MeTHF.

Detecting deception in pain expressions: the structure of genuine and deceptive facial displays.

Clinicians tend to assign greater weight to non-verbal expression than to patients' self-report when judging the location and severity of pain. Judgments can misrepresent the actual experience because patients can successfully alter their pain expressions. The present research provides a basis for discriminating genuine and deceptive pain expressions by expanding detailed accounts of facial expressions to include previously unexamined variables, including study of temporal patterns and contiguity of facial actions as well as the occurrence of specific deception cues. Low back patients' facial expressions (n=40) were videotaped at rest and while undergoing a painful straight leg raise with instructions to: (1) genuinely express their pain, or (2) pretend that it did not hurt. As well, they were asked to fake pain without moving. The Facial Action Coding System was used to describe and quantify facial activity. The different types of expression were compared on the frequency, type, intensity, temporal pattern and contiguity of facial actions, as well as on the frequency of specific deception cues. Findings confirmed the difficulty of discriminating the facial expressions, but indicated that faked pain expressions show a greater number of pain-related and non-pain-related actions, have a longer peak intensity and overall duration, and the facial actions observed tend to be less temporally contiguous than are those in genuine pain expressions. The differences between masked pain and neutral expressions were subtle, with a greater frequency of mouth opening and residual eyebrow movement in masked pain expressions. Thus, there is an empirical basis for discriminating genuine and deceptive facial displays.

Changes in readiness to self-manage pain are associated with improvement in multidisciplinary pain treatment and pain coping.

A patient's readiness to adopt a self-management approach to pain has been hypothesized to increase during multidisciplinary pain treatment and to impact pain coping responses. The Pain Stages of Change Questionnaire (PSOCQ; [J Pain (1997) 227]) was designed to assess four components of readiness to self-manage pain: pre-contemplation, contemplation, action, and maintenance. We tested three hypotheses concerning this construct in two different samples of patients with chronic pain: (1) readiness to self-manage pain, as assessed by the PSOCQ, would increase from pre-multidisciplinary pain treatment to post-treatment and follow-up; (2) changes in readiness to self-manage pain measured pre-treatment to post-treatment and follow-up would be associated with changes in the use of pain coping strategies; and (3) increases in readiness to self-manage pain would be associated with improvement in multidisciplinary pain treatment. The findings supported all three hypotheses. We discuss the implications of the findings for understanding motivational issues in the self-management of pain.

Readiness to self-manage pain is associated with coping and with psychological and physical functioning among patients with chronic pain.

A patient's readiness to adopt a self-management approach to pain has been suggested as a construct that may explain differences among patients in coping, adjustment, and response to multidisciplinary pain treatment. The pain stages of change questionnaire (PSOCQ; Pain, 72 (1997) 227) was designed to assess four components of this construct. The current study tested the following two hypotheses in two different samples of persons with chronic pain. PSOCQ scales are associated with (1) coping strategies used to manage pain and (2) patient disability and depression. The findings supported the first hypothesis and provided mixed support for the second. The implications of the findings for understanding the readiness to self-manage pain construct and the validity of the PSOCQ for assessing this construct are discussed.

Further evaluation of the pain stages of change questionnaire: is the transtheoretical model of change useful for patients with chronic pain?

Patient readiness to adopt new beliefs and coping responses to pain may predict response to multidisciplinary or cognitive-behavioral pain treatments that emphasize changes in beliefs and coping behaviors. According to the transtheoretical model of change, individuals go through specific stages in the process of changing maladaptive behaviors. Based on this model, Kerns et al. (1997) (Kerns RD, Rosenberg R, Jamison RN, Caudill MA, Haythornthwaite J. Readiness to adopt a self-management approach to chronic pain: the Pain Stages of Change Questionnaire (PSOCQ). Pain 1997;72:227-234) developed a measure of readiness to adopt a self-management approach to pain problems (the Pain Stages of Change Questionnaire; PSOCQ) and provided preliminary data supporting the validity of the measure. The current study sought to further evaluate the PSOCQ by determining the generalizability of these preliminary findings and the ability of the PSOCQ to classify persons with chronic pain into specific stages of readiness to self-manage pain. One hundred ten patients with diverse chronic pain problems, and 119 patients with fibromyalgia completed the PSOCQ and two measures of pain-related beliefs and coping prior to entry into two separate multidisciplinary pain programs. The internal consistency and concurrent validity of the PSOCQ subscales were largely replicated, supporting the validity of the subscales as measures of readiness to self-manage pain. However, the PSOCQ demonstrated less utility as a tool for classifying individuals into one of four specific stages of readiness to adopt a self-management approach. This result may be due to the classification procedure used in the current study, the characteristics of the samples in the study, specific limitations of the measure, and/or limitations in the applicability of the transtheoretical model of change to patients with chronic pain.

The relationship between cognitive appraisal, affect, and catastrophizing in patients with chronic pain.

A study was conducted to clarify the nature of catastrophizing, a construct that is frequently referred to in the chronic pain literature. Information regarding 3 affective experience and 3 affect regulation dimensions was gathered from a heterogeneous sample of 104 chronic pain patients by using a semistructured clinical interview and the Affect Regulation and Experience Q-Sort (AREQ). Self-report questionnaires included visual analog pain scales, the Coping Strategies Questionnaire (CSQ), Multidimensional Pain Inventory (MPI), McGill Pain Questionnaire (MPQ), and Center for Epidemiological Studies Depression scale (CES-D). Hierarchical multiple regression was used to demonstrate the relative contributions of affective and cognitive appraisal components of catastrophizing. Thirty-one percent of the variance in CSQ-Catastrophizing scores was explained by a combination of cognitive appraisal variables (perceived ability to control pain; MPI Life Control) and AREQ scores, even after adjusting for pain severity and chronicity, age, and sex of participants. Results of the study strongly suggest that, rather than thinking of catastrophizing primarily as a cognitive coping construct, it should be described as an elaborate construct made up of both cognitive appraisal and affective components. Implications for tailoring interventions to match individual styles of affect regulation are discussed.

Detecting deception in facial expressions of pain: accuracy and training.

Clinicians tend to assign greater weight to nonverbal expression than to patient self-report when judging the location and severity of pain. However, patients can be successful at dissimulating facial expressions of pain, as posed expressions resemble genuine expressions in the frequency and intensity of pain-related facial actions. The present research examined individual differences in the ability to discriminate genuine and deceptive facial pain displays and whether different models of training in cues to deception would improve detection skills. Judges (60 male, 60 female) were randomly assigned to 1 of 4 experimental groups: 1) control; 2) corrective feedback; 3) deception training; and 4) deception training plus feedback. Judges were shown 4 videotaped facial expressions for each chronic pain patient: neutral expressions, genuine pain instigated by physiotherapy range of motion assessment, masked pain, and faked pain. For each condition, the participants rated pain intensity and unpleasantness, decided which category each of the 4 video clips represented, and described cues they used to arrive at decisions. There were significant individual differences in accuracy, with females more accurate than males, but accuracy was unrelated to past pain experience, empathy, or the number or type of facial cues used. Immediate corrective feedback led to significant improvements in participants' detection accuracy, whereas there was no support for the use of an information-based training program.

Effective Tobacco Cessation via Health Coaching: An Institutional Case Report.

BACKGROUND: Tobacco abuse is a well-recognized scourge on health and healthcare costs. Attempts to facilitate tobacco cessation are rarely better than marginally effective. PRIMARY OBJECTIVE: To describe an observational trial of an existing and highly successful tobacco cessation program featuring health coaching as the primary intervention. Core components of program design and data are presented and may serve as a model for other public health settings. METHODS: Health coaching and three complementary program components (auriculotherapy, alpha-electrical stimulation, and relaxation techniques) are presented. Quit rates at 6 months for 161 patients over 3 years are provided featuring 30-day point prevalence smoke free and intent-to-treat values. Comparisons for telephonic vs in-clinic health coaching, free choice vs mandated participation, and program costs are provided. RESULTS: Point prevalence quit rate was 88.7% while the more conservative intent-to-treat quit rate was 51.6%. Telephonic and in-clinic health coaching were not significantly different at any time point. Smoke-free rates at 6 and 12 months were 76.9% and 63.2%, respectively. CONCLUSIONS: Two cost-effective smoking cessation models featuring health coaching are presented. Point prevalence (30-day) above 80% and an enduring effect was seen. Personal and societal burdens (health and financial) of tobacco use might be greatly impacted if such programs were successfully implemented on a larger scale.