Changes in Drug Utilization After Publication of Clinical Trials and Drug-Related Scandals in Japan: An Interrupted Time Series Analysis, 2005-2017.

BACKGROUND: Breaches of ethics undermine the practice of medicine. In Japan, two major scandals involving clinical research and drug marketing occurred after the publication of clinical trials. To study the effects of those scandals, we evaluated changes in the use of first-generation angiotensin II receptor blockers (ARBs) after publication of relevant clinical trials and also after the subsequent scandals. METHODS: We conducted a quasi-experimental design of an interrupted time series analysis (ITSA) on nationwide monthly drug-market data covering 12 years (2005 to 2017) in Japan. The main outcome was the use of first-generation ARBs (valsartan, candesartan, and losartan). The two exposures were the publication of ARB-related clinical-trial results (October 2006) and subsequent ARB-related scandals involving research and marketing (February 2013). A generalized estimating equation model was fitted for ITSA with a log link, Poisson distribution, robust variance estimators, and seasonality adjustment. RESULTS: The publication of clinical trials was associated with 12% increase in the use of first-generation ARBs in Japan, and the subsequent ARB-related scandals was associated with 19% decrease. The decrease in the use of first-generation ARBs after the scandals was greater than the increase in their use after the publication of clinical-trial results. The net effect of the two exposures was a 9% decrease in the use of first-generation ARBs. CONCLUSIONS: The scandals were associated with decrease in the use of first-generation ARBs, and that decrease was greater than the increase associated with the publication of "successful" clinical trials, making the net effect not zero but negative.

Association between health-related hope and adherence to prescribed treatment in CKD patients: multicenter cross-sectional study.

BACKGROUND: In chronic kidney disease (CKD), patients' adherence to prescriptions for diet and for medications might depend on the degree to which they have hope that they will enjoy life, and that hope could vary with the stage of CKD. The aims of this study were to quantify both the association of CKD stage with health-related hope (HR-Hope), and the association of that hope with psychological and physiological manifestations of adherence. METHODS: This was a cross-sectional study involving 461 adult CKD patients, some of whom were receiving dialysis. The main exposure was HR-Hope, measured using a recently-developed 18-item scale. The outcomes were perceived burden of fluid restriction and of diet restriction, measured using the KDQOL, and physiological manifestations of adherence (systolic and diastolic blood pressure [BP], and serum phosphorus and potassium levels). General linear models and generalized ordered logit models were fit. RESULTS: Participants at non-dialysis stage 4 and those at stage 5 had lower HR-Hope scores than did those at stage 2 or 3 (combined). Those at non-dialysis stage 5 had the lowest scores. HR-Hope scores of participants at stage 5D were similar to those of participants at stage 4, but they were lower than the scores of participants at stage 2 or 3 (combined). Higher HR-Hope scores were associated with lower perceived burdens of fluid restriction and of diet restriction (adjusted ORs per ten-point difference were 0.82 and 0.84, respectively). Higher HR-Hope scores were associated with lower systolic BP (adjusted mean difference in systolic BP per ten-point difference in HR-Hope scores was - 1.87 mmHg). In contrast, HR-Hope scores were not associated with diastolic BP, serum phosphorus levels, or serum potassium levels. CONCLUSIONS: Among CKD patients, HR-Hope is associated with disease stage, with psychological burden, and with some physiological manifestations of adherence.

Consumption of Lake Ontario sport fish and the incidence of colorectal cancer in the New York State Angler Cohort Study (NYSACS).

Fish consumption is hypothesized to reduce the risk of colorectal cancer. Nonetheless, consuming sport fish from the Great Lakes increases exposure to certain persistent organic pollutants, namely polychlorinated biphenyls (PCBs) and organochlorine insecticides, which may increase the risk of cancer. Evidence that exposure to persistent organic pollutants is associated with colorectal cancer is sparse. We examined colorectal cancer incidence in the New York State Angler Cohort Study (NYSACS), a prospective cohort of 17,110 anglers and spouses age 18-40 years at enrollment. In 1991, participants completed a mailed self-administered questionnaire that ascertained the number of years that fish from Lake Ontario were consumed, as well as potential confounders. Forty-one histologically confirmed first primary incident colorectal cancers diagnosed as of December 31, 2008 were identified via the New York State Cancer Registry. Vital status was ascertained by linkage with the Social Security Administration Death File. Rate ratios (RR) and 95% confidence intervals (CI) were calculated with Poisson regression, adjusting for age, pack-years of smoking, and sex. Compared with never consumers, colorectal cancer incidence was statistically non-significantly lower among consumers of Lake Ontario sport fish (RR=0.66; 95% CI: 0.35; 1.24). Incidence of colon cancer was lower among Lake Ontario sport fish consumers (RR=0.45, 95%CI: 0.20; 1.00). We did not observe any evidence of effect measure modification by sex or age. Although consumption of Lake Ontario sport fish may have an inverse association with colorectal cancer risk, inferences are complicated by a small number of cases and a lack of information regarding potential confounders including other dietary factors. However, our results do not provide support for the hypothesis that consumption of contaminated sport fish increases the risk of colorectal cancer.

Food-choice motives of adolescents in Jakarta, Indonesia: the roles of gender and family income.

OBJECTIVE: The aims of the present study were to assess the reliability and validity of the Food Choice Questionnaire (FCQ) and to determine the factors associated with food-choice motives in public junior-high-school students in Jakarta, Indonesia. DESIGN: Cross-sectional study with self-administered questionnaires. Trained research assistants measured height and weight of the participants on the day of the data collection. Settings Fourteen randomly selected public junior-high schools in East Jakarta, Indonesia. SUBJECTS: Public junior-high-school students (n 681) in grades 7 and 8, aged 13-14 years (377 girls and 304 boys). RESULTS: Three food-choice motives (subscales) were obtained from factor analysis and reliability testing: (i) comfort; (ii) convenience and price; and (iii) health. The subscale with the greatest mean value was health. Family affluence was inversely associated with the convenience and price subscale (ß=-0·05, P=0·01) and with the health subscale (ß=-0·04; P=0·02). Females were less likely than males to consider health when choosing foods (ß=-0·16; P=0·03). CONCLUSIONS: While its factor structure differed from those found in previous studies of adults, the FCQ can provide reliable measures of food-choice motives among these adolescents. Students from less affluent families placed more importance on food's convenience and price, but more affluent students did not necessarily make healthier choices. Compared with females, males were more likely to choose healthy foods. Future interventions should be tailored based on the socio-economic status of the target group.

A cross sectional study on fertility knowledge in Japan, measured with the Japanese version of Cardiff Fertility Knowledge Scale (CFKS-J).

BACKGROUND: A recent survey of 79 countries showed that fertility knowledge was lower in Japan than in any other developed country. Given the fertility decline in Japan and the importance of fertility knowledge, we conducted an online survey to examine fertility knowledge and the related factors for effective public education. METHODS: We studied people aged 18-59 years old, n = 4,328 (the "General" group), and also people who had been trying to conceive for at least six months, 18-50 years old, n = 618 (the "Triers" group). Fertility knowledge was assessed using the Japanese version of the 13-item Cardiff Fertility Knowledge Scale (CFKS-J). All participants provided socio-demographic and fertility information. Participants also completed a 14-item health literacy scale and an 11-item health numeracy scale. We asked participants who were aware of age-related decline in fertility when and where they first acquired that knowledge. RESULTS: The average percentages of CFKS-J items answered correctly were 53.1% in the Triers group and 44.4% in the General group (p < 0.001). Multivariate linear regression models showed in the Triers group greater fertility knowledge was associated with greater health literacy and prior medical consultation regarding their fertility. In the General group greater fertility knowledge was associated with being female, younger, university educated, currently trying to conceive, non-smoking, having higher household income, having higher health literacy and having higher health numeracy. Of those who were aware of the age-related decline in fertility, around 3% first learned the fact "at school", and around 65% first learned it "through mass media" or "via the Internet". More than 30% of the respondents first learned it "less than 5 years before" the survey. CONCLUSIONS: Although fertility knowledge had improved since a previous study, possibly due to recent media coverage of age-related infertility, it was still low. Educational interventions, both in schools and in the community, may be needed to increase fertility knowledge in the general population because most people obtain fertility knowledge from mass media, which has been shown to often present distorted and inaccurate fertility information.

International Collaboration and Commercial Involvement in Randomized Controlled Trials From 10 Leading Countries, 1997 Through 2019.

Randomized controlled trials (RCTs) affect clinical decisions and their number is increasing. However, trends in international collaboration on RCTs and involvement of healthcare-related industries, the latter of which may contribute to bias, are not known. The objectives were to identify concerns surrounding RCTs, and to quantify changes in (1) the numbers of RCT articles in journals of high clinical importance, (2) international collaboration, and (3) commercial involvement in RCTs by authors in countries that contribute the most to the scientific literature. This was not a systematic review of the medical literature. It is a descriptive study of trends during the past two decades. We extracted RCT articles from MEDLINE data (1997-2019). When grouped by authors' country, the analyses were limited to the 10 leading countries in the natural sciences, as defined by the Nature Index 2019 Annual Tables. The Core Clinical Journals (CCJ) filter in PubMed was used to identify journals that were likely to be highly relevant to clinical practice. RCT articles that included authors from multiple countries were used as examples of international collaboration, and RCTs in which at least one author's affiliation was corporate were considered to have commercial involvement. The annual number of RCT articles more than doubled (from 10,360 to 22,384), but the number published in the CCJ was essentially unchanged (from 2,245 to 2,346). The vast majority of RCT articles had US-based authors. International collaboration increased in nine of the 10 countries studied, and it was particularly common among researchers in Europe, Canada, and Australia. In contrast, international collaboration decreased in China. Regarding commercial involvement, between 1997 and 2019 the proportion of single-country RCTs with commercial involvement decreased (from 12.4% to 3.8% for the United States, and from 2.5% to 0.0% for Europe-Canada-Australia). In contrast, the proportion of international-collaborative RCTs with commercial involvement increased (from 9.2% to 17.6% for the United States, and from 17.9% to 21.3% for Europe-Canada-Australia). The largest change in commercial involvement was the 12-fold increase in Japan: from 3% to 36% (1997-2019). Japan was also noteworthy for its 28-percentage-point decrease in first-authorship of RCT articles from 2012 to 2019. In conclusion, recent increases in the number of RCT articles have occurred almost exclusively outside the CCJ. Thus, many newer RCT articles might have relatively low clinical relevance or impact. International collaboration has generally increased, along with commercial involvement. The latter has become particularly common in Japan, increasing the potential for sponsorship bias. The effects of ongoing attempts to reverse that trend should be evaluated.

Reliability tests and validation tests of the client satisfaction questionnaire (CSQ-8) as an index of satisfaction with childbirth-related care among Filipino women.

BACKGROUND: Satisfaction is an important indicator of the quality of care during childbirth. Previous research found that a good environment at a health facility can increase the number of deliveries at that facility. In contrast, an unsatisfying childbirth experience could cause postpartum mental disorder. Therefore it is important to measure mothers' satisfaction with their childbirth experiences. We tested whether the eight-item Client Satisfaction Questionnaire (CSQ-8) provided useful information about satisfaction with childbirth-related care. The government of the Philippines promotes childbirth at health facilities, so we tested the CSQ-8 in the Philippine cities of Ormoc and Palo. METHODS: This was a cross-sectional study. We targeted multigravid mothers whose last baby had been delivered at a hospital (without complications) and whose 2nd-to-last baby had been delivered at a hospital or at home (without complications). We developed versions of the CSQ-8 in Cebuano and Waray, which are two of the six major Filipino languages. Reliability tests and validation tests were done with data from 100 Cebuano-speaking mothers and 106 Waray-speaking mothers. RESULTS: Both the Cebuano and Waray versions of the CSQ-8 had high coefficients of internal-consistency reliability (greater than 0.80). Both versions were also unidimensional, which is generally consistent with the English CSQ-8 in a mental-health setting. As hypothesized, the scores for data regarding the second-to-last delivery were higher for mothers who had both their second-to-last and their last delivery in a hospital, than for mothers who had their second-to-last delivery at home and their last delivery in a hospital (Cebuano: p < 0.001, rho = 0.51, Waray: p < 0.001, rho = 0.55). CONCLUSIONS: Scores on the CSQ-8 can be used as indices of general satisfaction with childbirth-related services in clinical settings. This study also exemplifies a convenient method for developing versions of the CSQ-8 in more than one language. These versions of the CSQ-8 can now be used to assess mothers' satisfaction, so that mothers' opinions can be taken into account in efforts to improve childbirth-related services, which could increase the proportion of deliveries in medical facilities and thus reduce maternal mortality.

The overall impact of testing on medical student learning: quantitative estimation of consequential validity.

Given medical education's longstanding emphasis on assessment, it seems prudent to evaluate whether our current research and development focus on testing makes sense. Since any intervention within medical education must ultimately be evaluated based upon its impact on student learning, this report seeks to provide a quantitative accounting of the learning gains attained through educational assessments. To approach this question, we estimate achieved learning within a medical school environment that optimally utilizes educational assessments. We compare this estimate to learning that might be expected in a medical school that employs no educational assessments. Effect sizes are used to estimate testing's total impact on learning by summarizing three effects; the direct effect, the indirect effect, and the selection effect. The literature is far from complete, but the available evidence strongly suggests that each of these effects is large and the net cumulative impact on learning in medical education is over two standard deviations. While additional evidence is required, the current literature shows that testing within medical education makes a strong positive contribution to learning.

The response set theory of hypnosis reconsidered: toward an integrative model.

Irving Kirsch is a leading figure in the field of psychological science who has advanced our understanding of hypnosis in key respects that have withstood the tests of time and replication. We honor his prodigious contributions over his distinguished career and extend his response expectancy theory in an integrative model that encompasses predictive coding. We review the construct of expectancies that he articulated and championed for decades and extended in response set theory. We propose novel hypotheses to align his innovative contributions with the most current findings in psychological science and to acknowledge the heuristic value of his work. We especially focus on (I) how the response set theory can be conceptualized in terms of the predictive coding model and (II) psycho-social constructs that need to be considered to better understand the effects of expectancies on hypnotic phenomena in an open and evidence-based integrative model of hypnosis.

Challenging the utility of 24-hour recall of exclusive breast feeding in Japan.

INTRODUCTION: WHO recommends exclusive breast feeding from birth to 6 months. However, to monitor populations, it recommends using the proportion of infants under 6 months who were exclusively breastfed during the previous 24 hours. To assess the usefulness of 24-hour recall, we (1) compared the prevalence of exclusive breast feeding measured by since-birth recall to the prevalence measured by 24-hour recall and (2) quantified each indicator's association with WHO-recommended, well-established methods for in-hospital breastfeeding support. METHODS: We conducted two online surveys of mothers in Japan (total n=4247) who had a healthy singleton delivery in the previous 25 months. They reported on their breast feeding (a) from birth to 5 months; or (b) during the previous 24 hours, for those with infants under 5 months; or (c) both, for those who participated in the initial survey and also in the follow-up survey. All mothers also reported on their in-hospital support. The strength of each indicator's association with provision of in-hospital support was quantified as the area under the curve (AUC). RESULTS: The prevalences of exclusive breast feeding by since-birth recall were 4.4% (first survey) and 2.5% (second survey). By 24-hour recall, the prevalence appeared to be 29.8%. More in-hospital support was moderately well associated with more exclusive breast feeding measured by since-birth recall: AUC 0.72 (95%CI 0.66 to 0.78). That association is consistent with the known benefits of in-hospital support. In contrast, when exclusive breast feeding was measured by 24-hour recall, its association with in-hospital support appeared to be extremely weak: AUC 0.59 (95% CI 0.54 to 0.65). CONCLUSION: Using 24-hour recall substantially overestimates the prevalence of exclusive breast feeding since birth, and it conceals the benefits of in-hospital breastfeeding support. To monitor population achievement of exclusive breast feeding for the first 6 months, or to evaluate breastfeeding interventions, 24-hour recall of exclusive breast feeding should not be used alone.

Performance of alert transmissions from cardiac implantable electronic devices to the CareLink network: A retrospective analysis.

Background: Remote monitoring of cardiac implantable electric devices improves patient outcomes and experiences. Alert-based systems notify physicians of clinical or device issues in near real-time, but their effectiveness is contingent upon device connectivity. Objective: To assess patient connectivity by analyzing alert transmission times from patient transceivers to the CareLink network. Methods: Alert transmissions were retrospectively gathered from a query of the United States de-identified Medtronic CareLink database. Alert transmission time was defined as the duration from alert occurrence to arrival at the CareLink network and was analyzed by device type, alert event, and alert type. Using data from previous studies, we computed the benefit of daily connectivity checks. Results: The mean alert transmission time was 14.8 hours (median = 6 hours), with 90.9% of alert transmissions received within 24 hours. Implantable pulse generators (17.0 ± 40.2 hours) and cardiac resynchronization therapy-pacemakers (17.2 ± 42.5 hours) had longer alert transmission times than implantable cardioverter-defibrillators (13.7 ± 29.5 hours) and cardiac resynchronization therapy-defibrillators (13.5 ± 30.2 hours), but the median time was 6 hours for all 4 device types. There were differences in alert times between specific alert events. Based on our data and previous studies, daily connectivity checks could improve daily alert transmission success by 8.5% but would require up to nearly 800 additional hours of staff time on any given day. Conclusion: Alert transmission performance from Medtronic devices was satisfactory, with some delays likely underscored by patient connectivity issues. Daily connectivity checks could provide some improvement in transmission success at the expense of increased clinic burden.

At-home dried blood spot (DBS) collection to increase population heterogeneity representation in pediatric research: An ECHO study.

Self-collection of dried blood samples (DBS) in the participant's home provides an alternative to university/hospital visits for research and has the potential to improve the representation of population heterogeneity in research. This study aimed to assess the feasibility of guardian and/or self-DBS collection in healthy youth in the lab and home. Guardians/youth [N = 140; females = 63; M age = 8.73, SD age = 3.56] who enrolled in a longitudinal study of typical development were asked during a lab visit to provide a DBS. Upon providing a sample, the participants were asked if they would be willing to self-collect in the home and return the sample via the post office. Of those asked to provide a sample in the lab, 82% consented and 18% declined, with a significant difference in age but no significant difference in sex, ethnicity, race, or family income. Of those who provided a sample in the lab, 75% were willing to self-collect DBS in the home, with no significant difference in demographic variables between them. We report a quality assessment and DNA extraction results from a subset of samples. The results demonstrate a high feasibility of DBS collection from healthy youth for research purposes both in the laboratory and in the home across different demographic variables. Developmental researchers should consider including this approach in their studies to increase population heterogeneity representation.

Translation and Validation Testing of the Constipation-Related Quality of Life Scale for Use in Japan.

Introduction Establishing a scale that can easily be used to appropriately measure the impact of constipation on the quality of life in Japan is a first step toward addressing this important health issue. We developed a Japanese language version of the Constipation-Related Quality of Life scale, which has 18 items and four subscales, and then subjected it to validation testing. Methods After translation according to a standardized and commonly used procedure, the Japanese version of the Constipation-Related Quality of Life scale was administered to people in an internet-based panel, in March 2023. The participants included 1,276 adults who had constipation (median age: 60 years, 690 {54.1%} males). The outcome measures included the Constipation-Related Quality of Life scale, the Constipation Scoring System (an index of constipation severity), and the Medical Outcomes Study (MOS) eight-item short form (a measure of generic health-related quality of life). Results Confirmatory factor analysis (four-factor model) indicated that all 18 Constipation-Related Quality of Life items had sufficiently high factor loadings (0.686-0.926). Internal consistency reliability was high (Cronbach's alpha: 0.86-0.94). Scores on the social impairment subscale and on the distress subscale of the Constipation-Related Quality of Life scale were significantly worse in the participants who had worse scores on the social functioning and mental health domains, respectively, of the MOS eight-item short form, which indicates good concurrent validity. Regarding criterion-based validity, the four subscale scores differed significantly among the four constipation-severity groups. The four subscale scores were also 1.16-4.53 times more sensitive than the MOS eight-item short form's mental component score to differences among the four constipation-severity groups (relative validity: 1.16-4.53), which indicates good discriminant validity. Conclusion The Japanese version of the Constipation-Related Quality of Life scale can be used with confidence in its factor structure, its concurrent, criterion-based, and discriminant validity, and its internal consistency reliability.

Poor Social Functioning: A Potentially Modifiable Risk Factor for Pneumonia in the Elderly.

Background Most risk factors for developing community-acquired pneumonia (CAP) are age-related and chronic medical conditions; modifying these factors can be challenging, especially in the elderly. Poor social functioning, however, has a negative impact on medical conditions but can be improved through interventions. Therefore, the social functioning domain of health-related quality of life (HRQOL) may be a modifiable risk factor for the development of CAP. This study investigated the association between poor social functioning and the incidence of CAP in elderly individuals. Methodology We conducted a retrospective cohort study using a dataset from 2018 to 2021, derived from an annual questionnaire-based survey of a cohort of community-dwelling people aged 75 years or older (the Sukagawa Study). The dataset included social functioning subscale scores of HRQOL obtained from the Eight-Item Short Form (SF-8) questionnaire. Health insurance claims data were matched with these HRQOL data. For each participant, the exposure (HRQOL) was measured, and outcomes (incidence of CAP) were observed yearly from 2018 through 2021. Results The four observation years had a total of 17,016 observation periods among 6,513 participants. The annual incidence rate of CAP was 0.90-1.77%. Lower social functioning was associated with a higher risk of CAP. Specifically, for each standard deviation difference in social functioning score, the adjusted rate ratio for CAP incidence was 1.26 (95% confidence interval (CI) = 1.08-1.48). In a subgroup analysis, the association between social functioning and CAP differed by sex (p = 0.037). Specifically, the adjusted rate ratio for CAP incidence was 1.41 (95% CI = 1.17-1.70) in men and 1.00 (95% CI = 0.76-1.35) in women. Conclusions Poor social functioning is an important risk factor for CAP in the elderly, especially in men. Interventions that improve social functioning may help to prevent CAP.

Pilot study suggests DNA methylation of the glucocorticoid receptor gene (NR3C1) is associated with MDMA-assisted therapy treatment response for severe PTSD.

Background: Previous research has demonstrated that epigenetic changes in specific hypothalamic-pituitary-adrenal (HPA) genes may predict successful psychotherapy in post-traumatic stress disorder (PTSD). A recent Phase 3 clinical trial reported high efficacy of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy for treating patients with severe PTSD compared to a therapy with placebo group (NCT03537014). This raises important questions regarding potential mechanisms of MDMA-assisted therapy. In the present study, we examined epigenetic changes in three key HPA axis genes before and after MDMA and placebo with therapy. As a pilot sub-study to the parent clinical trial, we assessed potential HPA epigenetic predictors for treatment response with genomic DNA derived from saliva (MDMA, n = 16; placebo, n = 7). Methylation levels at all 259 CpG sites annotated to three HPA genes (CRHR1, FKBP5, and NR3C1) were assessed in relation to treatment response as measured by the Clinician-Administered PTSD Scale (CAPS-5; Total Severity Score). Second, group (MDMA vs. placebo) differences in methylation change were assessed for sites that predicted treatment response. Results: Methylation change across groups significantly predicted symptom reduction on 37 of 259 CpG sites tested, with two sites surviving false discovery rate (FDR) correction. Further, the MDMA-treatment group showed more methylation change compared to placebo on one site of the NR3C1 gene. Conclusion: The findings of this study suggest that therapy-related PTSD symptom improvements may be related to DNA methylation changes in HPA genes and such changes may be greater in those receiving MDMA-assisted therapy. These findings can be used to generate hypothesis driven analyses for future studies with larger cohorts.

Attitudes about hypnosis: factor analyzing the VSABTH-C with an American sample.

In the present study, the authors factor-analyzed responses from 1,141 American undergraduate students to the Valencia Scale of Attitudes and Beliefs Toward Hypnosis-Client Version. They obtained an 8-factor solution accounting for 66% of the total variance in responses. A confirmatory factor analysis indicated acceptable fit of their model and those reported earlier by Carvalho et al. (2007) and Capafons, Mendoza, et al. (2008) using Portuguese and international samples, respectively. Unlike previous factor analyses of the scale, the authors obtained an independent clusters solution. Distinctions between the authors' model and those reported previously are discussed.

God Locus of Health Control, Paranormal Beliefs, and Hypnotizability.

Belief in the paranormal (e.g., spirits, extrasensory perception, fortune telling, extraterrestrials) is common. Extraordinary and magical beliefs have been linked with hypnotizability. A total of 167 undergraduates completed measures of paranormal and magical beliefs, locus of control, absorption, fantasy proneness, expectancy about being hypnotized, and the God Locus of Health Control scale (GLHC) and were hypnotized with the HGSHS:A. High and medium hypnotizable participants more strongly agreed with statements reflecting paranormal and magical beliefs and the assertion that God directly controls their health, relative to those less responsive to hypnosis. Using stepwise regression, we found that expectations about hypnosis along with scores on the GLHC scale accounted for 26% and 30% of the variance in behavioral and subjective scores on the HGSHS:A, respectively. The authors discuss paranormal beliefs and the link between the GLHC and hypnotizability.

Relapse and Outcome of Lupus Nephritis After Renal Transplantation in the Modern Immunosuppressive Era.

Background Recurrence of lupus nephritis in the graft is a concern in lupus patients with end-stage renal disease undergoing renal transplantation. The recurrence of lupus nephritis has been variable among different studies depending on the patient characteristics, immunosuppressive regimen, and indications of renal biopsy. Therefore, we investigated the recurrence of lupus nephritis among our patients to see if the new post-transplant regimen has impacted the recurrence. Methods We collected data on all recipients with end-stage renal disease secondary to lupus nephritis, who received renal transplants between 2006-2017 in our center. Patient demographics, transplant, and dialysis-related information have been recorded including kidney biopsy, graft loss, and survival were recorded. An association between recurrent lupus nephritis with survival and/or graft loss was examined using survival models. Results The overall mean±SD age at baseline was 42±13 years; 89% were female; 89% were African American; the previous time on dialysis was a median of 4 years (IQR: 2-8 years), 81% received hemodialysis and 31% received living donor transplantation in the cohort. Our patients received the standard immunosuppressive regimen consisting of prednisone, tacrolimus, and mycophenolate mofetil. Four (10.5%) of the 38 patients had biopsy-proven lupus nephritis recurrence. A total of 10 patients (26%) had graft loss or died during the median follow-up time of 1,230 days (IQR: 460-2,227 days). Recurrence of lupus nephritis showed a trend for increased risk of graft loss or patient death (Hazard Ratio: 3.14, 95%Confidence Interval: 0.65-15.24) compared to the recipient without recurrence in our unadjusted proportional Cox regression model. Conclusion The recurrence rate of lupus nephritis in our patient population is much lower compared to past studies from different immunosuppressive eras. Patients with recurrent lupus nephritis showed an increased risk of graft loss or death.

Predicting complete loss to follow-up after a health-education program: number of absences and face-to-face contact with a researcher.

BACKGROUND: Research on health-education programs requires longitudinal data. Loss to follow-up can lead to imprecision and bias, and complete loss to follow-up is particularly damaging. If that loss is predictable, then efforts to prevent it can be focused on those program participants who are at the highest risk. We identified predictors of complete loss to follow-up in a longitudinal cohort study. METHODS: Data were collected over 1 year in a study of adults with chronic illnesses who were in a program to learn self-management skills. Following baseline measurements, the program had one group-discussion session each week for six weeks. Follow-up questionnaires were sent 3, 6, and 12 months after the baseline measurement. A person was classified as completely lost to follow-up if none of those three follow-up questionnaires had been returned by two months after the last one was sent.We tested two hypotheses: that complete loss to follow-up was directly associated with the number of absences from the program sessions, and that it was less common among people who had had face-to-face contact with one of the researchers. We also tested predictors of data loss identified previously and examined associations with specific diagnoses.Using the unpaired t-test, the U test, Fisher's exact test, and logistic regression, we identified good predictors of complete loss to follow-up. RESULTS: The prevalence of complete loss to follow-up was 12.2% (50/409). Complete loss to follow-up was directly related to the number of absences (odds ratio; 95% confidence interval: 1.78; 1.49-2.12), and it was inversely related to age (0.97; 0.95-0.99). Complete loss to follow-up was less common among people who had met one of the researchers (0.51; 0.28-0.95) and among those with connective tissue disease (0.29; 0.09-0.98). For the multivariate logistic model the area under the ROC curve was 0.77. CONCLUSIONS: Complete loss to follow-up after this health-education program can be predicted to some extent from data that are easy to collect (age, number of absences, and diagnosis). Also, face-to-face contact with a researcher deserves further study as a way of increasing participation in follow-up, and health-education programs should include it.