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1.

Background

No study to date has examined the effectiveness of integrating clinical decision support tools, like electronic health record (EHR) alerts, into the clinical care of youth at-risk for suicide.

Objective

This study aimed to examine the feasibility and acceptability of using an EHR alert to increase clinicians’ use of safety planning with youth at-risk for suicide in an outpatient pediatric psychiatry clinic serving an urban low-income Latino community.

Methods

An alert intervention was developed to remind clinicians to complete a safety plan whenever they documented that their patient endorsed suicidal ideation, plan, or attempt during a visit in EHR notes. The alert appeared as a separate window containing a reminder message to complete a safety plan once a clinician finished visit documentation.

Results

There were 69 at-risk patients between the ages of 13–21 in the intervention period (M = 15.71; SD = 1.86; 66.7% female) and 64 (M = 15.38; SD = 1.93; 68.6% female) in the control period. Logistic regression analyses indicated that patients in the intervention period were significantly more likely than patients in the control period to receive a safety plan (p < .01). The pattern of results remained the same after adjusting for demographic variables (p = .01). Forty clinicians also completed a questionnaire assessing their satisfaction with the EHR alert, indicating moderate satisfaction (M = 3.01; SD = 0.63; range = 1.11–4.11).

Conclusions

EHR alerts are associated with changes in clinicians’ behavior and improved compliance with best clinical practices for at-risk youth.
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2.

Objectives

The purpose of this study was to explore whether two types of emotional labor, surface acting and deep acting, are related to hair cortisol concentration among kindergarten teachers.

Methods

Surface acting and deep acting over the last month were measured with the Chinese version of the emotional labor scale in 43 kindergarten teachers. Hair samples with 1 cm in length were cut from their posterior vertex region to represent cortisol excretion over one month. Cortisol concentrations were analyzed with high-performance liquid chromatography–tandem mass spectrometry.

Results

Positive association of emotion labor with hair cortisol concentration was significant for surface acting (r = 0.34, p < 0.05) and not significant for deep acting (r = 0.14, p > 0.05).

Conclusions

More surface acting showed to be associated stronger with stress responses or higher HPA axis activity.
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3.

Purpose

Cardiac cell therapy is a promising treatment for acute myocardial infarction (AMI), leading to cardiac function improvement. However, whether it translates into quality of life (QoL) improvement is unclear. We hypothesized that administration of bone marrow cells (BMC) to patients with AMI improves QoL.

Methods

In the multicenter BONAMI trial (NCT00200707), patients with reperfused AMI and decreased myocardial viability were randomized to intracoronary autologous BMC infusion (n = 52) or state-of-the-art therapy (n = 49). QoL data, derived from the Minnesota Living with Heart Failure questionnaire (MLHFQ), were obtained 1, 3, and 12 months after AMI and analyzed using a Rasch-family model.

Results

Using this model, QoL improved over time in the BMC group (p = 0.025) but not in the control group. Furthermore, the BMC-group patients displayed a better QoL than the control-group patients at 3 and 12 months post-AMI (p = 0.034 and p = 0.003, respectively). These findings were not detected when analyzing MLHFQ data using a standard method. Cardiac function, myocardial viability, mortality, and number of major adverse cardiac events did not differ between treatment groups.

Conclusion

Our results suggest that BMC therapy can improve QoL, stressing the need for confirmation trials and for systematic QoL assessment in cardiac cell therapy trials .
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4.

Purpose

Caffeine-containing energy drinks (EDs) are currently used as ergogenic aids to improve physical performance in a wide variety of sport disciplines. However, the outcomes of previous investigations on this topic are inconclusive due to methodological differences, especially, in the dosage of the active ingredients and the test used to assess performance.

Methods

We performed a systematic review and meta-analysis of published studies to evaluate the effects of acute ED intake on physical performance. The search for references was conducted in the databases PubMed, ISI Web of Knowledge and SPORTDiscus until December 2015.

Results

Thirty-four studies published between 1998 and 2015 were included in the analysis. Using a random-effects model, effect sizes (ES) were calculated as the standardized mean difference. Overall, ED ingestion improved physical performance in muscle strength and endurance (ES = 0.49; p < 0.001), endurance exercise tests (ES = 0.53; p < 0.001), jumping (ES = 0.29; p = 0.01) and sport-specific actions (ES = 0.51; p < 0.001), but not in sprinting (ES = 0.14; p = 0.06). The meta-regression demonstrated a significant association between taurine dosage (mg) and performance (slope = 0.0001; p = 0.04), but not between caffeine dosage (mg) and performance (slope = 0.0009; p = 0.21).

Conclusion

ED ingestion improved performance in muscle strength and endurance, endurance exercise tests, jumping and sport-specific actions. However, the improvement in performance was associated with taurine dosage.
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5.

Purpose

The validity of the life satisfaction measures commonly used among adults has been rarely examined in adolescent samples. The present research had two main goals: (1) to evaluate the structural validity of the Satisfaction with Life Scale (SWLS) among adolescents and to test measurement invariance across gender; (2) to compare the criterion and convergent validity of the SWLS and single-item life satisfaction measures among adolescents.

Methods

Three samples of Serbian adolescents were recruited for the present research. Study 1 (N = 481, M age = 17.01 years) examined the structure of the SWLS via confirmatory factor analysis (CFA) and evaluated measurement invariance of the SWLS across gender by a multi-group CFA. Study 2 (N = 283, M age = 17.34 years) and Study 3 (N = 220, M age = 16.73 years) compared the convergent validity of the SWLS and single-item life satisfaction measures.

Results

The results of Study 1 supported the original one-factor model of the SWLS among adolescents and provided evidence for strong measurement invariance of the SWLS across gender. The findings of Study 2 and Study 3 showed that the SWLS and single-item measures were equally valid and strongly associated (r = .734 in Study 2 and r = .668 in Study 3). No substantial differences in correlations with school success and well-being indicators were found between the SWLS and single-item measures.

Conclusions

Our findings support the use of the SWLS among adolescents and indicate that single-item life satisfaction measures perform as well as the SWLS in adolescent samples.
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6.

Background

It is well known that the antipsychotic drugs impact the health-related quality of life (HRQoL) of the bipolar patients. The side effects had been assessed only from the doctors’ perspective and neglected the patients’ subjective feeling. The aim of the study is to validate the specific instrument “tolerability and quality of life” (TOOL) into Chinese to describe and grade the impact of antipsychotic drugs on HRQoL from patients’ view.

Methods

A psychometric study was conducted with euthymic bipolar disorder patients (N = 105) under antipsychotic treatment. The psychometric properties of the TOOL, including internal consistency, retest reliability, concurrent validity, content validity, discriminative validity, item analysis, confirmatory factor analysis and feasibility, were analyzed.

Results

The internal consistency and intraclass correlation coefficient (ICC) were adequate (Cronbach’s alpha = 0.80 and ICC = 0.81). A confirmatory factor analysis (CFA) validated the one-factor model. Significant Spearman’s rank correlations between the TOOL and both Bref QoL.BD (Brief version of Quality of Life in Bipolar Disorder) (r = ?0.33, P < 0.01) and UKU (Udvalg for Kliniske Undersogelser side effects scale) (r = 0.13, P < 0.05) were found.

Limitations

Small sample size and no specific self-report instrument in Chinese to evaluate the criterion validity.

Conclusions

TOOL appears to be a reliable and valid measure to assess the impact of adverse events of antipsychotic drugs on HRQoL from the patients’ perspective.
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7.

Purpose

Alcoholic liver disease or non-alcoholic fatty liver disease/non-alcoholic steatohepatitis are well-known risk factors for liver fibrosis or cirrhosis and hepatocellular carcinoma; it is a major global health concern, but there are few effective and safe management options. Therefore, we aimed to investigate the effects of fermented garlic extracts (FGEs) on hepatic function in adults with mild hepatic dysfunction without underlying hepatic disease.

Methods

In this double-blind, randomized, placebo-controlled study, seventy-five adults with elevated serum gamma-glutamyl transpeptidase (GGT) levels were included in a FGE-administered group (n = 36) or a placebo group (n = 39), and received either two sachets/day containing FGEs or placebo over a 12-week period. Primary endpoint was the change in serum GGT levels. Data were analysed using a generalized linear mixed effects model.

Results

Significant group × time interactions for serum levels of GGT (F = 3.98, P = 0.022) and alanine aminotransferase (ALT; F = 3.28, P = 0.043) were observed with an improvement in levels of GGT (P = 0.066) and ALT (P = 0.014) in the FGE group compared to that reported for the placebo group at the 12-week visits. There was no intergroup difference in the prevalence of adverse events.

Conclusions

Intake of FGEs improved serum GGT and ALT levels in adults with mildly elevated serum GGT level without reported adverse side effects. FGEs might be effective and safe management options for mild hepatic dysfunction.
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8.

Objective

The present study investigated the reinforcing value of healthy and unhealthy snack food in adolescents (n = 108, aged 14–16 years). Moderation by access to different foods, sex and the personality trait reward sensitivity is tested.

Methods

In a computerized Food Reinforcement Task, adolescents could earn portions of a healthy and an unhealthy snack following an identical progressive reinforcement schedule for both food types. Reinforcing value of food was indexed by the number of button presses for each food type. Participants were allocated randomly to two-order condition: fruit–snack versus snack–fruit. Reward sensitivity was assessed with the Dutch age-downward version of Carver and White’s BIS/BAS scale.

Results

Results showed that the reinforcing value of an unhealthy snack is higher than that of fruit, with participants making more button presses for unhealthy snacks, M = 1280.40, SD = 1203.53, than for fruit, M = 488.04, SD = 401.45, F(1,48) = 25.37, p < 0.001. This effect is stronger in boys (β = ?1367.67) than in girls (β = ?548.61). The effect is only present in the snack–fruit condition, not in the fruit–snack condition, indicating that access to food moderates the effect of food type. There is no evidence for moderation by reward sensitivity.

Conclusions

Results point to the importance of simultaneously increasing barriers to obtain unhealthy food and promoting access to healthy food in order to facilitate healthy food choices.
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9.

Purpose

This cross-sectional study assesses the relationship between consumption frequencies of food items and high-sensitivity C-reactive protein (hs-CRP) in European children.

Methods

Out of the baseline sample (N = 16.228) of the IDEFICS study, 6.403 children (1.315 boys aged 2 to <6, 1.908 boys aged 6 to <10, 1.204 girls aged 2 to <6 and 1.976 girls aged 6 to <10 years) had hs-CRP measured and the Children’s Eating Habits Questionnaire filled, including a food frequency questionnaire. Logistic regression adjusted for body mass index z-score, education of the mother, breast-feeding and self-reported hours of physical activity in a sport club per week was conducted.

Results

Mean frequency intake of raw vegetable was lower in boys (p = 0.022 in young and p = 0.020 in old) and older girls (p = 0.026) with high hs-CRP concentration, while in younger girls (p = 0.008) the same occurred with the cooked vegetables. The probability of having higher hs-CRP concentration was significantly associated with having low consumption frequency of vegetables (p = 0.004 in older boys, raw vegetables; and p = 0.0032 in younger girls, cooked vegetables). Also, honey/jam intake decreased the probability of having higher concentration of hs-CRP, whereas soft drinks with sugar, mayonnaise and cereals milled increased this probability.

Conclusions

Out of all food items associated with hs-CRP, frequency intake of vegetables presented more associations across all the analysis. Findings suggest that a high-frequency intake of vegetables is inversely related to an inflammatory status in children. More studies are needed to assess the association between diet and inflammation.
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10.

Purpose

This study aimed (1) to examine the role of potential correlates of HRQoL in a large representative sample of older adults, and (2) to investigate whether the relationships between HRQoL and potential factors differ as a function of HRQoL component (physical vs. mental) and/or age cohort (young-old vs. old–old).

Methods

This cross-sectional study included 802 older adults aged 60–79 years old. HRQoL was assessed using the SF-36 questionnaire. Functional fitness was assessed using the Senior Fitness Test. Physical activity was measured via the Baecke questionnaire. Demographic information, mental and health features were obtained through questionnaires.

Results

A multiple regression analysis showed that BMI (β = ?0.15, p?=?0.001), body strength (β =?0.21, p?<?0.001), aerobic endurance (β =?0.29, p?<?0.001), physical activity (β =?0.11, p?=?0.007), depressive symptoms (β = ?0.19, p?<?0.001), falls (β = ?0.19, p?<?0.001), and living alone (β = ?0.16, p?<?0.001) were all significantly related to HRQoL-SF-36 total score. The positive relation with aerobic endurance was significantly higher for the physical component of HRQoL, while the negative relation with living alone was significantly higher for the mental component. The positive relation of HRQoL with physical activity was significantly higher in old–old compared to young-old adults.

Conclusion

This data suggest that body composition, functional fitness, psycho-social factors, and falls are important correlates of HRQoL in old age. There are HRQoL-component and age-cohort differences regarding these correlates, underlying the need for specific strategies at the community level to promote HRQoL in older adults.
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11.

Purpose

In Malaysia, hip fracture incidence is higher in Chinese women than other ethnic groups. This study compared the effects of a high-calcium vitamin D fortified milk with added FOS-inulin versus regular milk over 1 year on aspects of bone health in Chinese postmenopausal women in Malaysia.

Methods

One-hundred and twenty-one women (mean age 59 (± 4) years) were randomized into two groups: control (n = 60; regular milk, 428 mg calcium per day) or intervention (n = 61; fortified milk at 1200 mg calcium, 96 mg magnesium, 2.4 mg zinc, 15 μg vitamin D and 4 g FOS-inulin per day). At baseline, weeks 12, 24, 36 and 52, parathyroid hormone (PTH), C-Telopeptide of Type I Collagen (CTx-1), Procollagen I Intact N-Terminal propeptide (PINP) and vitamin D levels were assessed. Bone density (BMD) was measured at baseline and week 52 using a GE Lunar iDXA.

Results

Body mass index, lumbar spine and femoral neck BMD did not differ between groups at baseline. Over 52 weeks, mean plasma 25 (OH) D3 levels increased to 74.8 nmol/L (intervention group) or remained at 63.1 nmol/L (control group) (p < 0.001 between groups). PTH levels increased in the control group (p = 0.001). The intervention resulted in a significant suppression of CTx-1 and PINP at p = 0.018 and p = 0.004. Femoral neck BMD remained stable in the intervention group but decreased significantly in the controls, with a borderline treatment effect (p = 0.07).

Conclusion

Compared with regular milk, the fortified milk suppressed bone turnover markers and tended to increase femoral neck BMD.
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12.

Purpose

The aim of this 10-year follow-up study was to determine changes in health-related quality of life (HRQoL) over time among ambulatory persons with MS (PwMS) at the baseline using generic and disease-specific instruments.

Methods

Of 109 independently walking PwMS included in a population-based study in 2002, 77 (70.6 %) were re-assessed in 2012. HRQoL was captured using the 36-Item Short Form Survey Instrument (RAND-36), 15D instrument (15D), and the Multiple Sclerosis Quality of Life-54 (MSQOL-54). Repeated-measures ANOVA and effect size (ES) calculations (Cohen’s d) were used in the statistical analysis.

Results

The RAND-36 physical health composite score (p = 0.003, ES = 0.26) and 15D total score (p = 0.012, ES = 0.25) declined from the baseline levels. In particular, lower scores were observed on the RAND-36 scales of physical functioning (p = 0.001, ES = 0.27), pain (p = 0.020, ES = 0.25), and general health perceptions (p = 0.002, ES = 0.36), on the MSQOL-54 scales of physical functioning (p = 0.001, ES = 0.27), pain (p = 0.040, ES = 0.21), sexual functioning (p = 0.003, ES = 0.43), and satisfaction with sexual functioning (p = 0.012, ES = 0.38), and in the 15D dimensions of mobility (p = 0.004, ES = 0.31) and sexual functioning (p ≤ 0.001, ES = 0.59). Improvement was observed on the RAND-36 scale of social functioning (p = 0.049, ES = 0.25). The other composite scores, scales, and dimensions remained unchanged.

Conclusion

The results of this study suggest that ambulatory PwMS at baseline reported reduced HRQoL in physical functioning after a 10-year follow-up period, while emotional well-being was maintained and social functioning improved. The scores in the other HRQoL dimensions and scales remained unchanged. More long-term population-based studies are needed to precisely determine the development of HRQoL among PwMS.
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13.

Purpose

People with Parkinson’s disease (PD) may experience stigma due to their visible features of movement and communication difficulties. This paper aimed to examine the role of experienced stigma in health-related quality of life (QOL), after controlling for personal and clinical characteristics.

Methods

This is a preliminary analysis of a subset of baseline data from the Social Self-Management of Parkinson’s Disease Study (SocM-PD), an ongoing 3-year prospective cohort study. Seventy-three people with PD (M age = 65.72, 29 women) participated in this study. Hierarchical multiple regression analyses were used to determine the role of stigma in QOL, after controlling for gender, disease severity, depression, and motor difficulties of daily living.

Results

Significant correlations were found between QOL with gender (r = .26), disease severity (r = .38), depression (r = .65), motor difficulties of daily living (r = .71), and stigma (r = .83). After controlling for the significant covariates, stigma made a significant and unique contribution to the explanation of QOL by 13.7 % (p < 0.001). A final hierarchical multiple regression with stigma and the 4 covariates revealed an overall model that explained 77.8 % of the total variance of QOL (F [5, 63] = 48.79, p < 0.001).

Conclusions

Experienced stigma appears to be a key determinant of QOL in people with PD. The results suggest the importance of further understanding stigma in PD to develop possible intervention strategies. Future work is also needed to verify the results with a larger and longitudinal dataset of the SocM-PD.
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14.

Objective

The aim of this study was to explore the relations between toe pinch force and other muscle strength parameters in male patients with type 2 diabetes mellitus.

Methods

A total of 40 men with type 2 diabetes (age: 53.4 ± 13.1 years, duration of diabetes: 8.5 ± 8.1 years) who needed exercise training were enrolled in this cross-sectional study. We evaluated the clinical parameters and 4 muscle strength parameters, which were toe pinch force, handgrip strength, isometric knee extension force, and isometric ankle dorsiflexion force.

Results

The HbA1c, toe pinch force, handgrip strength, isometric knee extension force, and isometric ankle dorsiflexion force were 10.1 ± 2.4 %, 3.2 ± 1.2 kg, 37.3 ± 7.0 kg, 39.6 ± 11.4 kgf, and 17.0 ± 6.3 kgf, respectively. Toe pinch force was significantly correlated with handgrip strength (r = 0.365, p = 0.0206), isometric knee extension force (r = 0.668, p < 0.0001), and isometric ankle dorsiflexion force (r = 0.514, p = 0.0007). All muscle strength parameters were significantly lower in patients with diabetic polyneuropathy than in those without polyneuropathy.

Conclusion

Although toe pinch force was significantly correlated with the other muscle strength parameters, the correlation was not so strong. However, evaluation of toe pinch force might be recommended for assessment of distal limb muscle strength in patients with type 2 diabetes.
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15.

Purpose

The Warwick–Edinburgh Mental Well-being Scale (WEMWBS), 14 positively worded statements, is a validated instrument to measure mental wellbeing on a population level. Less is known about the population distribution of the shorter seven-item version (SWEMWBS) or its performance as an instrument to measure wellbeing.

Methods

Using the Health Survey for England 2010–2013 (n = 27,169 adults aged 16+, nationally representative of the population), age- and sex-specific norms were estimated using means and percentiles. Criterion validity was examined using: (1) Spearman correlations (ρ) for SWEMWBS with General Health Questionnaire (GHQ-12), happiness index, EQ-VAS (2) a multinomial logit model with SWEMWBS (low, medium and high wellbeing) as the outcome and demographic, social and health behaviours as explanatory variables. Relative validity was examined by comparing SWEMWBS with WEMWBS using: (1) Spearman correlations (continuous data), and (2) the weighted kappa statistic (categorical), within population subgroups.

Results

Mean (median) SWEMWBS was 23.7 (23.2) for men and 23.2 (23.2) for women (p = 0.100). Spearman correlations were moderately sized for the happiness index (ρ = 0.53, P < 0.001), GHQ-12 (ρ = ?0.52, p < 0.001) and EQ-VAS (ρ = 0.40, p < 0.001). Participants consuming <1 portion of fruit and vegetables a day versus ≥5 (odds ratio = 1.43 95% Confidence Interval = (1.22–1.66)) and current smokers versus non-smokers (1.28 (1.15–1.41)) were more likely to have low vs medium wellbeing. Participants who binge drank versus non-drinkers were less likely to have high versus medium wellbeing (0.81 (0.71–0.92)). Spearman correlations between SWEMWBS and WEMWBS were above 0.95; weighted kappa statistics showed almost perfect agreement (0.79–0.85).

Conclusion

SWEMWBS distinguishes mental wellbeing between subgroups, similarly to WEMWBS, but is less sensitive to gender differences.
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16.

Purpose

The University of Washington Self-Efficacy Scale (UW-SES) was originally developed for people with multiple sclerosis (MS) and spinal cord injury (SCI). This study evaluates the measurement invariance of the 6-item short form of the UW-SES across four disability subgroups. Evidence of measurement invariance would extend the UW-SES for use in two additional diagnostic groups: muscular dystrophy (MD) and post-polio syndrome (PPS).

Methods

Multi-group confirmatory factor analysis was used to evaluate successive levels of measurement invariance of the 6-item short form, the UW-SES: (a) configural invariance, i.e., equivalent item-factor structures between groups; (b) metric invariance, i.e., equivalent unstandardized factor loadings between groups; and (c) scalar invariance, i.e., equivalent item intercepts between groups. Responses from the four groups with different diagnostic disorders were compared: MD (n = 172), MS (n = 868), PPS (n = 225), and SCI (n = 242).

Results

The results of this study support that the most rigorous form of invariance (i.e., scalar) holds for the 6-item short form of the UW-SES across the four diagnostic subgroups.

Conclusions

The current study suggests that the 6-item short form of the UW-SES has the same meaning across the four diagnostic subgroups. Thus, the 6-item short form is validated for people with MD, MS, PPS, and SCI.
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17.

Objective

The objective of the present investigation was to examine the association of mindful creativity with the trajectory of recovery (emotional, interpersonal, cognitive, and total functioning) of patients with severe TBI.

Methods

This was drawn from a subsample of an adult prospective cohort study on severe TBI in Switzerland; patients and their relatives were assessed at 3, 6, and 12 months (patients N = 176, relatives N = 176). Predictor measures were assessed using Mindful Creativity Scale—short form and time (trajectory of functioning of the patient over time). Outcome measures were assessed using Patient Competency Rating Scale for Neuro-rehabilitation (PCRS-NR; measuring emotional, interpersonal, cognitive, and total functioning post-injury). All measures were assessed at each time point. Mixed linear models were run separately for ages >50 and ≤50 (i.e., bimodal distribution).

Results

Patients’ mindful creativity showed no significant association with patients’ functioning across time in any of the models. In all age groups, interpersonal functioning decreased across time (slope>50 = ?4.66, p = .037; slope≤50 = ?7.19, p = .007). Interestingly, in age group ≤50, interpersonal functioning increased when looking at relative mindful creativity by time (slope = 1.69, p = .005). Additionally, relatives mindful creativity was significantly associated with patients’ functioning in age group ≤50: (a) patients’ total functioning (slope = 0.18, p = .03) and (b) cognitive functioning (slope = 0.72, p = .020).

Conclusions

Relatives’ mindful creativity was significantly associated with patients’ functioning after severe TBI. Implications for treatment and future research are discussed.
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18.

Purpose

The present placebo-controlled, double-blind, randomized trial aimed to investigate whether a natural mineral water rich in magnesium sulphate and sodium sulphate (Donat Mg) may help to improve bowel function.

Methods

A total of 106 otherwise healthy subjects with functional constipation were randomly assigned to consume 300 or 500 mL of a natural mineral water as compared to placebo water, over a course of 6 weeks. The 300-mL arms were terminated due to the results of a planned interim analysis. Subjects documented the complete spontaneous bowel movements, spontaneous and overall bowel movements/week, stool consistency, gastrointestinal symptoms and general well-being in a diary. Change in the number of complete spontaneous bowel movements was defined as the primary outcome.

Results

For the 75 subjects in the 500-mL arms, the change in the number of complete spontaneous bowel movements per week tended to be higher in the active group when compared to placebo after 6 weeks (T2 = 1.8; p value = 0.036; one-sided). The mean number of spontaneous bowel movements significantly increased over the course of the study, with significant differences between study arms considering the whole study time (F test = 4.743; p time × group = 0.010, 2-sided). Stool consistency of spontaneous bowel movements (p < 0.001) and the subjectively perceived symptoms concerning constipation (p = 0.005) improved significantly with the natural mineral water as compared to placebo.

Conclusions

The daily consumption of a natural mineral water rich in magnesium sulphate and sodium sulphate improved bowel movement frequency and stool consistency in subjects with functional constipation. Moreover, the subjects’ health-related quality of life improved.

Clinical Trial Registration

EudraCT No 2012-005130-11.
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19.

Objective

Adolescent vaccination coverage under a system of non school-based vaccination is likely to be suboptimal, but might be increased by targeted encouragement campaigns. We analysed the effect on human papillomavirus (HPV) vaccination initiation by girls aged 12–18 of two campaigns set up in Flanders (Belgium) in 2007 and 2009: a personal information campaign and a combined personal information and financial incentive campaign.

Methods

We analysed (objective) data on HPV vaccination behaviour from the National Alliance of Christian Mutualities (NACM), Flanders’ largest sickness fund. We used z-scores to compare the monthly proportion of girls initiating HPV vaccination over time between carefully selected intervention and control groups. Separate analyses were done for older and younger girls. Total sample sizes of the intervention (control) groups were 221 (243) for the personal information campaign and 629 (5,322) for the combined personal information and financial incentive campaign.

Results

The personal information campaign significantly increased vaccination initiation, with older girls reacting faster. One year after the campaign the percentages of vaccination initiation for the oldest girls were 64.6 and 42.8 % in the intervention and control group, respectively (z = 3.35, p = 0.0008); for the youngest girls the percentages were 78.4 and 68.1 % (z = 1.71, p = 0.09). The combined personal information and financial incentive campaign increased vaccination initiation among certain age groups. One year after the campaign the difference in percentage points for HPV vaccination initiation between intervention and control groups varied between 18.5 % (z = 3.65, p = 0.0002) and 5.1 % (z = 1.12, p = 0.26).

Conclusion

Under a non school-based vaccination system, personal information and removing out-of-pocket costs had a significant positive effect on HPV vaccination initiation, although the effect substantially varied in magnitude. Overall, the obtained vaccination rates remained far below those realised under school-based HPV vaccination.
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20.

Purpose

Epidemiologic data on whether consumption of fruit and vegetables (FVs) decreases the risk of gallstone disease are sparse. Therefore, we examined the association between FV consumption and the 14-year risk of symptomatic gallstone disease (defined as occurrence of cholecystectomy) in a large group of middle-aged and elderly persons.

Methods

Data from two population-based cohorts were used, which included 74,554 men and women (born 1914–1952). Participants filled in a food frequency questionnaire in the late fall of 1997 and were followed up for cholecystectomy between 1998 and 2011 via linkage to the Swedish Patient Register. Cox regression models were used to obtain hazard ratios (HRs).

Results

During 939,715 person-years of follow-up, 2120 participants underwent a cholecystectomy (1120 women and 1000 men). An inverse association between FV consumption and risk of cholecystectomy was observed in age- and sex-adjusted analyses (P trend = .036) but not in confounder-adjusted analyses (P trend = .43). The multivariable-adjusted HR was 0.95 (95 % CI 0.83–1.08) for the highest compared with the lowest sex-specific quartile of FV consumption. There was no evidence of interactions with age (P = .25) or sex (P = .72) in analyses pooled by sex. However, an age-by-FV consumption interaction was observed in separate analyses of women (P = .010), with decreased HRs of cholecystectomy for ages up to 60 years.

Conclusions

This study supports an inverse association between FV consumption and risk cholecystectomy in women, although the association was restricted to women aged 48–60 years. In contrast, the study does not support an association in men.
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