Effectiveness of oncogenetics training on general practitioners’ consultation skills: a randomized controlled trial

PurposeGeneral practitioners are increasingly called upon to deliver genetic services and could play a key role in translating potentially life-saving advancements in oncogenetic technologies to patient care. If general practitioners are to make an effective contribution in this area, their genetics competencies need to be upgraded. The aim of this study was to investigate whether oncogenetics training for general practitioners improves their genetic consultation skills.MethodsIn this pragmatic, blinded, randomized controlled trial, the intervention consisted of a 4-h training (December 2011 and April 2012), covering oncogenetic consultation skills (family history, familial risk assessment, and efficient referral), attitude (medical ethical issues), and clinical knowledge required in primary-care consultations. Outcomes were measured using observation checklists by unannounced standardized patients and self-reported questionnaires.ResultsOf 88 randomized general practitioners who initially agreed to participate, 56 completed all measurements. Key consultation skills significantly and substantially improved; regression coefficients after intervention were equivalent to 0.34 and 0.28 at 3-month follow-up, indicating a moderate effect size. Satisfaction and perceived applicability of newly learned skills were highly scored.ConclusionThe general practitioner–specific training proved to be a feasible, satisfactory, and clinically applicable method to improve oncogenetics consultation skills and could be used as an educational framework to inform future training activities with the ultimate aim of improving medical care.Genet Med16 1, 45–52.     

Longitudinal study: Impact of communication skills training and a traineeship on medical students’ attitudes toward communication skills

ObjectivesTo study longitudinally students’ attitudes towards communication skills (CS) in order to examine whether CS training (CST) has an enduring impact on medical students’ attitudes toward being a lifelong learner of CS.Methods105 students completed the Communication Skills Attitude Scale at 4 times: before CST, after CST and before and after a traineeship.ResultsOur final sample size is 105 students. CST improved the attitudes of our students toward CS, and the traineeship stabilised those attitudes. However, while the improvement in positive attitudes was sustained over time, negative attitudes increased 6 months after CST.ConclusionCST using experiential methods in a safe environment has the potential to improve students’ attitudes towards CS. A short traineeship in general medicine allows students to quickly integrate CST into clinical practice, without deteriorating their attitudes toward CS. However, 6 months of medical lessons without CST reinforces students’ negative attitudes.Practice implicationsTo avoid the deterioration of attitudes over time, CST should be continuous or at least spaced at intervals less than 6 months and supported by the institutional authorities. In addition, placing the CST close to an observation traineeship in general practice seems an interesting way to prevent further deterioration of attitudes.     

The learning effects of different presentations of worked examples on medical students’ breaking-bad-news skills: A randomized and blinded field trial

Objectives

Effective instructional approaches are needed to enable undergraduates to optimally prepare for the limited training time they receive with simulated patients (SPs). This study examines the learning effects of different presentation formats of a worked example on student SP communication.

The effect of a scalable online training module for shared decision making based on flawed video examples – a randomized controlled trial

ObjectiveShared Decision Making (SDM) is considered the gold standard of medical decision making as it provides a method to systematically integrate the patient’s preferences, evidence-based medicine and the experience of health care professionals. Therefore, evidence-based training methods for a broad implementation into healthcare are needed. A new online training was designed, based on the concept of flawed/flawless video examples and additional educational concepts.MethodsIn a single-blind randomized-controlled trial, medical students were randomly assigned to intervention group receiving the online training (n = 82) or waiting control group (n = 105). SDM-related knowledge and the ability to judge distinct levels of SDM were compared between both groups. Additionally, feedback regarding the intervention was collected.ResultsSDM-related knowledge and judging ability increased significantly in the intervention group compared to controls (SDM knowledge: mean difference: 12 %; 95 % CI: 7.3–18.5; p < 0.001; SDM judging ability (inter-rater concordance displayed by weighted t): mean difference: 0.07; 95 %CI: 0.03?0.11; p = 0.001). Feedback was positive.ConclusionThe online training with its distinctive methodology prove effective. As it shares the theoretical and didactical background with an already existing face-to-face training, both approaches may also be used complementarily.Practice ImplicationsSDM can be trained effectively and efficiently with this easily scalable online training.     

The safety and immunogenicity of a cell-derived adjuvanted H5N1 vaccine – A phase I randomized clinical trial

BackgroundDevelopment of an efficacious egg-free mock-up H5N1 vaccine is key to our preparedness against pandemic avian flu.MethodsThis is a single-center, randomized, observer-blinded phase I clinical trial evaluating the safety and immunogenicity of an alum-adjuvanted Madin–Darby canine kidney (MDCK)-derived inactivated whole-virion H5N1 influenza vaccine in healthy adults. Hemagglutination inhibition (HAI) and neutralizing antibody titers were measured using horse and turkey red blood cells (RBCs).ResultsThirty-six adult subjects were randomized to receive two doses of 0.5 mL of the MDCK-derived H5N1 alum-adjuvanted vaccine containing 7.5, 15, or 30 μg of hemagglutinin (HA) 21 days apart. The candidate vaccine was well tolerated and safe across the three dosing groups. The most frequent adverse event was injection site pain (46.5%). Both HAI and neutralizing antibody titers increased after each vaccination in all three dosing groups. The best HAI responses, namely a seroconversion rate of 91.7% and a geometric mean ratio of 9.51 were achieved with the HA dose of 30 μg assayed using horse RBCs at day 42. HAI titers against H5N1 avian influenza virus was significantly higher when measured using horse RBCs compared with turkey RBCs.ConclusionsThis Phase I trial showed the MDCK-derived H5N1 candidate vaccine is safe and immunogenic. The source of RBCs has a significant impact on the measurement of HAI titers (ClinicalTrials.gov number: NCT01675284.).     

Efficacy of Papacarie® in reduction of residual bacteria in deciduous teeth: a randomized,controlled clinical trial

OBJECTIVES:

The aim of the present study was to analyze the efficacy of Papacarie® gel compared with the traditional method (low-speed bur) in reducing the counts of total bacteria, Lactobacillus, total Streptococcus and Streptococcus mutans group.

METHODS:

A randomized, controlled clinical trial with a split-mouth design was performed. The sample comprised 40 deciduous teeth in 20 children (10 males and 10 females) aged four to seven years. The teeth were randomly allocated to two groups: G1, or chemomechanical caries removal with Papacarie Duo®, and G2, or the removal of carious dentin tissue with a low-speed bur. Infected dentin was collected prior to the procedure, and the remaining dentin was collected immediately following the removal of the carious tissue. Initial and final counts of bacterial colonies were performed to determine whether there was a reduction in the number of colony-forming units (CFUs) of each microorganism studied. ClinicalTrials.gov: {"type":"clinical-trial","attrs":{"text":"NCT01811420","term_id":"NCT01811420"}}NCT01811420.

RESULTS:

Reductions were found in the numbers of total bacteria, total Streptococcus and Streptococcus mutans group following either of the caries removal methods (p<0.05). A reduction was also noted in the number of Lactobacillus CFUs; however, this difference did not achieve statistical significance (p>0.05).

CONCLUSION:

Papacarie® is an excellent option for the minimally invasive removal of carious tissue, achieving significant reductions in total bacteria, total Streptococcus and S. mutans with the same effectiveness as the traditional caries removal method.     

The impact of the sequence of pulmonary vessel ligation during anatomic resection for lung cancer on long-term survival – a prospective randomized trial

PurposeThe aim of this prospective randomized trial was to assess the influence of the sequence of pulmonary vessel ligation, during anatomic resection, on long term survival in patients with NSCLC.Material/MethodsThis prospective randomized study included 385 patients treated surgically with lobectomy or pneumonectomy and standard lymphadenectomy between 1999 and 2003. Patients were randomly assigned to either primary ligation of the pulmonary artery or arteries (group A – 215 patients) or of the pulmonary vein or veins (group V – 170 patients). Patients were excluded if the sequence of vessel ligation was affected by technical difficulties or anatomic limitations. Univariate and multivariate analyses included: the sequence of vessel ligation, age, gender, tumor histology, stage (TNM), and cause of death (cancer related or non-cancer related).ResultsMedian follow-up was 63 months. The groups were comparable regarding gender, histology, type of resection, and T, N, and overall stage. Overall, 5-year survival reached 50% in group A and 54% in group V (p = 0.82) and did not differ significantly in cancer related and non-cancer related deaths (p = 0.67 and p = 0.26, respectively). Univariate analysis identified higher T and N factors, advanced stage, pneumonectomy, male sex, and older age as negative prognostic factors. Multivariate analysis demonstrated that age, T3–4 disease, and nodal involvement were associated with inferior survival.ConclusionsThe sequence of pulmonary vessel ligation during anatomic resection for non-small cell lung cancer does not significantly affect long-term survival.     

The effect of a supplementary (‘gist-based’) information leaflet on colorectal cancer knowledge and screening intention: a randomized controlled trial

Guided by Fuzzy Trace Theory, this study examined the impact of a ‘Gist-based’ leaflet on colorectal cancer screening knowledge and intentions; and tested the interaction with participants’ numerical ability. Adults aged 45–59 years from four UK general practices were randomly assigned to receive standard information (‘The Facts’, n = 2,216) versus standard information plus ‘The Gist’ leaflet (Gist + Facts, n = 2,236). Questionnaires were returned by 964/4,452 individuals (22 %). 82 % of respondents reported having read the information, but those with poor numeracy were less likely (74 vs. 88 %, p < .001). The ‘Gist + Facts’ group were more likely to reach the criterion for adequate knowledge (95 vs. 91 %; p < .01), but this was not moderated by numeracy. Most respondents (98 %) intended to participate in screening, with no group differences and no interaction with numeracy. The improved levels of knowledge and self-reported reading suggest ‘The Gist’ leaflet may increase engagement with colorectal cancer screening, but ceiling effects reduced the likelihood that screening intentions would be affected.     

The effect of Neuragen PN<Superscript>®</Superscript> on Neuropathic pain: A randomized,double blind,placebo controlled clinical trial

Background

A double blind, randomized, placebo controlled study to evaluate the safety and efficacy of the naturally derived topical oil, "Neuragen PN^®" for the treatment of neuropathic pain.

Methods

Sixty participants with plantar cutaneous (foot sole) pain due to all cause peripheral neuropathy were recruited from the community. Each subject was randomly assigned to receive one of two treatments (Neuragen PN^® or placebo) per week in a crossover design. The primary outcome measure was acute spontaneous pain level as reported on a visual analog scale.

Results

There was an overall pain reduction for both treatments from pre to post application. As compared to the placebo, Neuragen PN^® led to significantly (p < .05) greater pain reduction. Fifty six of sixty subjects (93.3%) receiving Neuragen PN^® reported pain reduction within 30 minutes. This reduction within 30 minutes occurred in only twenty one of sixty (35.0%) subjects receiving the placebo. In a break out analysis of the diabetic only subgroup, 94% of subjects in the Neuragen PN^® group achieved pain reduction within 30 minutes vs 11.0% of the placebo group. No adverse events were observed.

Conclusions

This randomized, placebo controlled, clinical trial with crossover design revealed that the naturally derived oil, Neuragen PN^®, provided significant relief from neuropathic pain in an all cause neuropathy group. Participants with diabetes within this group experienced similar pain relief.

Trial registration

ISRCTN registered: ISRCTN13226601

     

How pragmatic or explanatory is the randomized, controlled trial? The application and enhancement of the PRECIS tool to the evaluation of a smoking cessation trial

ABSTRACT: BACKGROUND: Numerous explanatory randomized trials support the efficacy of chronic disease interventions, including smoking cessation treatments. However, there is often inadequate adoption of these interventions for various reasons, one being the limitation of generalizability of the explanatory studies in real-world settings. Randomized controlled trials can be rated as more explanatory versus pragmatic along 10 dimensions. Pragmatic randomized clinical trials generate more realistic estimates of effectiveness with greater relevance to clinical practice and for health resource allocation decisions. However, there is no clear method to scale each dimension during the trial design phase to ensure that the design matches the intended purpose of the study. METHODS: We designed a pragmatic, randomized, controlled study to maximize external validity by addressing several barriers to smoking cessation therapy in ambulatory care. We analyzed our design and methods using the recently published 'Pragmatic-Explanatory Continuum Indicatory Summary (PRECIS)' tool, a qualitative method to assess trial design across 10 domains. We added a 20-point numerical rating scale and a modified Delphi process to improve consensus in rating these domains. RESULTS: After two rounds of review, there was consensus on all 10 domains of study design. No single domain was scored as either fully pragmatic or fully explanatory; but overall, the study scored high on pragmatism. CONCLUSIONS: This addition to the PRECIS tool may assist other trial designers working with interdisciplinary co-investigators to rate their study design while building consensus.     

Vitamin D supplementation to persistent carriers of MRSA—a randomized and placebo-controlled clinical trial

Methicillin-resistant Staphylococcus aureus (MRSA) is resistant to all beta-lactam antibiotics and can cause severe infections that are difficult to treat. Eradication strategies with conventional antibiotics are not always effective and alternative approaches are warranted. Here, we tested the hypothesis that daily supplementation with vitamin D for 12 months would reduce MRSA carriage rates among a group of persistent carriers. This was a double-blind, placebo-controlled randomized trial with n?=?65 persistent MRSA carriers with 25-hydroxy vitamin D₃ (25OHD) <?75 nmol/L, who were followed up with bacterial cultures at baseline and every 3 months for 1 year. The primary endpoint was the decline in MRSA positivity during the study period. The study was conducted in two MRSA outpatient clinics at the Karolinska University Hospital, Stockholm, Sweden. In total, n?=?65 persistent MRSA carriers were randomized and n?=?3 were lost to follow-up. Only patients deficient in vitamin D (<?75 nmol/L) were included. Vitamin D (4000 IU) or placebo/day was administered for 12 months. The decline in MRSA positivity was equal in the vitamin D and placebo group during the study period (OR, 1.00; 95% CI, 0.97–1.03; p?=?0.928) and approximately 40% in both groups were MRSA-negative after 12 months. The vitamin D group produced 103 positive cultures out of 318 cultures (32.4%) from nose, throat, and perineum over the study period, whereas the placebo group produced 135/393 positive cultures (34.0%) (Fisher’s exact test, p?=?0.94). Vitamin D supplementation did not influence MRSA carriage. Thus, available data does not support vitamin D supplementation to persistent MRSA carriers.Trial registration: www.clinicaltrials.gov; NCT02178488.     

Effect of raloxifene and low-dose percutaneous 17β-estradiol on menopause symptoms and endometrium—A randomized controlled trial

Objective

To investigate the effects on climacteric symptoms and endometrium of percutaneous low-dose 17β-estradiol associated with raloxifene in postmenopausal women.

Design

randomized placebo-controlled study.

Method

Fifty-two postmenopausal women with moderate to severe hot flushes were randomized to receive either 60 mg raloxifene (RLX; n = 20), 0.5 mg percutaneous 17β-estradiol associated to 60 mg raloxifene (RLX + E₂; n = 16) or placebo (PLC; n = 16). Climacteric symptoms (Kupperman index) and vaginal bleeding were evaluated. At baseline and at the end of the study endometrial thickness was measured and endometrial samples were collected for histological study.

Results

At baseline, the mean Kupperman index was 23.7 ± 1.8 in RLX group, 22.9 ± 1.9 in RLX + E₂ group and 22.6 ± 1.9 in the placebo group (NS). After 3 months, there was a significant reduction in Kupperman index mean values in both groups, but no statistical difference was observed between groups. However, RLX + E₂ and placebo were significantly superior to RLX in reducing hot flush severity (p < 0.05). Endometrial thickness did not change in both groups. The association of percutaneous low-dose 17β-estradiol to raloxifene was not associated with proliferation of endometrium neither in hysteroscopies nor in endometrial biopsies at the third month of treatment. No vaginal bleeding was reported during the study.

Conclusions

The association of percutaneous low dose of 17β-estradiol with raloxifene exerted favorable effects on hot flushes severity of postmenopausal women, providing a safe profile in endometrium at least in short-term therapy.     

The impact of HLA-G 3′ UTR variants and sHLA-G on risk and clinical correlates of schizophrenia

The Major Histocompatibility Complex (MHC)/Human Leukocyte Antigen (HLA) is known to influence the pathogenesis of several complex human diseases resulting from gene-environmental interactions. Recently, it has emerged as one of the risk determinants of schizophrenia. The HLA-G protein (a non-classical MHC class I molecule), encoded by the HLA-G gene, is shown to play important role in embryonic development. Importantly, its genetic variations and aberrant expression have been implicated in pregnancy complications like preeclampsia, inflammation, and autoimmunity. Converging evidence implicates these phenomena as risk mechanisms of schizophrenia. However, the functional implications of HLA-G in schizophrenia are yet to be empirically examined. The impact of two functional polymorphisms [14 bp Insertion/Deletion (INDEL) and +3187 A > G] and soluble HLA-G (sHLA-G) levels on schizophrenia risk was evaluated. In this exploratory study, the Ins/Ins genotype of 14 bp INDEL was found to confer a strong risk for schizophrenia. Further, low levels of sHLA-G were shown to have a significant impact on Clinical Global Impression (CGI) severity in people with schizophrenia.     

Effectiveness of low-dose doxycycline (LDD) on clinical symptoms of Sjögren's Syndrome: a randomized,double-blind,placebo controlled cross-over study

Background

Matrix metalloproteinases (MMPs) are proteolytic enzymes that may contribute to tissue destruction in Sjögren's syndrome (SS). Low-dose doxycycline (LDD) inhibits MMPs. We evaluated the efficacy of LDD for the subjective symptoms in primary SS patients.This was a randomized, double blind, placebo controlled cross-over study. 22 patients were randomly assigned to receive either 20 mg LDD or matching placebo twice a day for 10 weeks. The first medication period was followed by 10-week washout period, after which the patient received either LDD or placebo, depending on the first drug received, followed by the second washout period. Stimulated saliva flow rates and pH were measured before and after one and ten weeks of each medication and after washout periods. VAS scale was used to assess the effect of LDD and placebo on following six subjective symptoms: xerostomia; xerophtalmia; difficulty of swallowing; myalgia; arthralgia; and fatigue. The effect was evaluated for each medication and washout period separately.

Results

Overall, the effects of medications on subjective symptoms were minor. Wilcoxon test demonstrated increased fatigue with LDD during medication (p < 0.05). The differences may, however, reflect normal fluctuation of symptoms in SS patients.

Conclusion

LDD may not be useful in reducing the primary SS symptoms.

     

Evaluation of a spirituality informed e-mental health tool as an intervention for major depressive disorder in adolescents and young adults – a randomized controlled pilot trial

Background

Depression in adolescents and young adults is a major mental health condition that requires attention. Research suggests that approaches that include spiritual concepts and are delivered through an online platform are a potentially beneficial approach to treating/managing depression in this population. The purpose of this study was to evaluate the effectiveness of an 8-week online spirituality informed e-mental health intervention (the LEAP Project) on depression severity, and secondary outcomes of spiritual well-being and self-concept, in adolescents and young adults with major depressive disorder of mild to moderate severity.

Methods

A parallel group, randomized, waitlist controlled, assessor-blinded clinical pilot trial was conducted in Calgary, Alberta, Canada. The sample of 62 participants with major depressive disorder (DSM-IV-TR) was defined by two age subgroups: adolescents (ages 13 to 18 years; n?=?31) and young adults (ages 19 to 24 years; n?=?31). Participants in each age subgroup were randomized into the study arm (intervention initiated upon enrolment) or the waitlist control arm (intervention initiated after an 8-week wait period). Comparisons were made between the study and waitlist control arms at week 8 (the point where study arm had completed the intervention and the waitlist control arm had not) and within each arm at four time points over 24-week follow-up period.

Results

At baseline, there was no statistical difference between study and waitlist participants for both age subgroups for all three outcomes of interest. After the intervention, depression severity was significantly reduced; comparison across arms at week 8 and over time within each arm and both age subgroups. Spiritual well-being changes were not significant, with the exception of an improvement over time for the younger participants in the study arm (p?=?0.01 at week 16 and p?=?0.0305 at week 24). Self-concept improved significantly for younger participants immediately after the intervention (p?=?0.045 comparison across arms at week 8; p?=?0.0175 in the waitlist control arm) and over time in the study arm (p?=?0.0025 at week 16). In the older participants, change was minimal, with the exception of a significant improvement in one of six factors (vulnerability) in study arm over time (p?=?0.025 at week 24).

Conclusions

The results of the LEAP Project pilot trial suggest that it is an effective, online intervention for youth ages 13 to 24 with mild to moderate major depressive disorder with various life situations and in a limited way on spiritual well-being and self-concept.

Trial registration

ClinicalTrials.gov NCT00985686. Registered 24 September 2009.

     

Chronic low-back pain: what does cognitive coping skills training add to operant behavioral treatment? Results of a randomized clinical trial

This study examined the supplemental value of a cognitive coping skills training when added to an operant-behavioral treatment for chronic low-back pain patients. The complete treatment package (OPCO) was compared with an operant program + group discussion (OPDI) and a waiting-list control (WLC). After the WL period, the WLC patients received a less protocolized operant program usually provided in Dutch rehabilitation centers (OPUS). Regression analyses showed that, compared with WLC, both OPCO and OPDI led to less negative affect, higher activity tolerance, less pain behavior, and higher pain coping and pain control. At posttreatment, OPCO led to better pain coping and pain control than OPDI. Calculation of improvement rates revealed that OPCO and OPDI had significantly more improved patients than OPUS on all the dependent variables. The discussion includes findings regarding treatment credibility, compliance, and contamination bias.     

The eye as a model of ageing in translational research – Molecular,epigenetic and clinical aspects

The eye and visual system are valuable in many areas of translational research such as stem cell therapy, transplantation research and gene therapy. Changes in many ocular tissues can be measured directly, easily and objectively in vivo (e.g. lens transparency; retinal blood vessel calibre; corneal endothelial cell counts) and so the eye may also be a uniquely useful site as a model of ageing. This review details cellular, molecular and epigenetic mechanisms related to ageing within the eye, and describes ocular parameters that can be directly measured clinically and which might be of value in ageing research as the translational “window to the rest of the body”. The eye is likely to provide a valuable model for validating biomarkers of ageing at molecular, epigenetic, cellular and clinical levels. A research agenda to definitively establish the relationship between biomarkers of ageing and ocular parameters is proposed.