Do clinical guidelines introduced with practice based education improve care of asthmatic and diabetic patients? A randomised controlled trial in general practices in east London.

OBJECTIVE--To determine whether locally developed guidelines on asthma and diabetes disseminated through practice based education improve quality of care in non-training, inner city general practices. DESIGN--Randomised controlled trial with each practice receiving one set of guidelines but providing data on the management of both conditions. SUBJECTS--24 inner city, non-training general practices. SETTING--East London. MAIN OUTCOME MEASURES--Recording of key variables in patient records (asthma: peak flow rate, review of inhaler technique, review of asthma symptoms, prophylaxis, occupation, and smoking habit; diabetes: blood glucose concentration, glycaemic control, funduscopy, feet examination, weight, and smoking habit); size of practice disease registers; prescribing in asthma; and use of structured consultation "prompts." RESULTS--In practices receiving diabetes guidelines, significant improvements in recording were seen for all seven diabetes variables. Both groups of practices showed improved recording of review of inhaler technique, smoking habit, and review of asthma symptoms. In practices receiving asthma guidelines, further improvement was seen only in recording of review of inhaler technique and quality of prescribing in asthma. Sizes of disease registers were unchanged. The use of structured prompts was associated with improved recording of four of seven variables on diabetes and all six variables on asthma. CONCLUSIONS--Local guidelines disseminated via practice based education improve the management of diabetes and possibly of asthma in inner city, non-training practices. The use of simple prompts may enhance this improvement.     

Are fibre supplements really necessary in diverticular disease of the colon? A controlled clinical trial.

Fifty-eight patients with uncomplicated diverticular disease of the colon took bran crispbread, ispaghula drink, and placebo for four months each in a randomised, cross-over, double-blind controlled trial. Assessments were made subjectively, using a monthly self-administered questionnaire, and objectively, by examining a seven-day stool collection at the end of each treatment period. In terms of a pain score, lower bowel symptom score (the pain score and sensation of incomplete emptying, straining, stool consistency, flatus, and aperients taken), and total symptom score (belching, nausea, vomiting, dyspepsia, and abdominal distension) fibre supplementation conferred no benefit. Symptoms of constipation, however, when assessed alone, were significantly relieved. Both fibre regimens produced the expected changes in stool weight, consistency, and frequency. It is concluded that dietary fibre supplements in the commonly used doses do no more than relieve constipation. Perhaps the impression that fibre helps diverticular disease is simply a manifestation of Western civilisation''s obsession with the need for regular frequent defecation.     

Do physicians assess lifestyle health risks during general medical examinations? A survey of general practitioners and obstetrician-gynecologists in Quebec

BACKGROUND: In Canada several guidelines have been published for the screening of lifestyle health risks during general medical examinations. The authors sought to examine the extent to which such screening practices have been integrated into medical practice, to measure physicians'' perceived level of difficulty in assessing these risks and to document physicians'' evaluation of their formal medical training in lifestyle risk assessment. METHODS: An anonymous mail survey was conducted in 1995 in Quebec with a stratified random sample of 1086 general practitioners (GPs) and with all 241 obstetrician-gynecologists (Ob-Gyns). The authors evaluated the proportion of physicians who reported routine assessment (with 90% or more of their patients) of substance use, family violence and sexual history during general medical examinations of adult and adolescent patients; the proportion of those who find inquiring about these issues difficult; and the proportion of those who evaluated their medical training in lifestyle risk assessment as adequate or excellent. RESULTS: The overall response rate was 72.6%. Among adult patients, 82.2% of the GPs reported routinely assessing tobacco use, 67.2% alcohol consumption, 34.2% illicit drug use and 3.2% family violence; the corresponding proportions for assessment among adolescent patients were 77.1%, 61.8%, 52.9% and 5.6%. Comparatively fewer Ob-Gyns reported routinely assessing these issues (56.1%, 28.6%, 20.4% and 1.3% respectively among adults and 62.7%, 35.2%, 26.8% and 2.8% respectively among adolescents). In the area of sexual history, condom use was routinely assessed by more Ob-Gyns than GPs (47.0% v. 28.2%); however, the proportion of Ob-Gyns and GPs was equally low for assessing number of partners (24.8% and 23.1%), sexual orientation (18.8% and 16.9%) and STD risk (26.2% and 21.2%). The vast majority of GPs and Ob-Gyns reported finding it difficult to assess family violence (86.5% and 93.0%) and sexual abuse (92.7% and 92.4% respectively). Over 80% of the physicians felt that they had had adequate or excellent medical training in assessing risk behaviours for heart disease and STD risk. The proportion who felt this way about their training in screening for illicit drug use, family violence and sexual abuse ranged between 12.7% and 31.6%. INTERPRETATION: Although morbidity and mortality associated with smoking, alcohol consumption, illicit drug use, unsafe sexual practices, family violence and sexual abuse have been well documented, routine screening for these risk factors during general medical examinations has yet to be integrated into medical practice.     

Effect of 50?000 IU vitamin A given with BCG vaccine on mortality in infants in Guinea-Bissau: randomised placebo controlled trial

Objective To investigate the effect of high dose vitamin A supplementation given with BCG vaccine at birth in an African setting with high infant mortality.Design Randomised placebo controlled trial.Setting Bandim Health Project’s demographic surveillance system in Guinea-Bissau, covering approximately 90 000 inhabitants. Participants 4345 infants due to receive BCG.Intervention Infants were randomised to 50 000 IU vitamin A or placebo and followed until age 12 months.Main outcome measure Mortality rate ratios.Results 174 children died during follow-up (mortality=47/1000 person-years). Vitamin A supplementation was not significantly associated with mortality; the mortality rate ratio was 1.07 (95% confidence interval 0.79 to 1.44). The effect was 1.00 (0.65 to 1.56) during the first four months and 1.13 (0.75 to 1.68) from 4 to 12 months of age. The mortality rate ratio in boys was 0.84 (0.55 to 1.27) compared with 1.39 (0.90 to 2.14) in girls (P for interaction=0.10). An explorative analysis revealed a strong interaction between vitamin A and season of administration.Conclusions Vitamin A supplementation given with BCG vaccine at birth had no significant benefit in this African setting. Although little doubt exists that vitamin A supplementation reduces mortality in older children, a global recommendation of supplementation for all newborn infants may not contribute to better survival.Trial registration Clinical trials {"type":"clinical-trial","attrs":{"text":"NCT00168597","term_id":"NCT00168597"}}NCT00168597.     

Extended role for general practitioners in obstetrics? A medical audit.

A study was designed to evaluate provision of services, process of medical care, and outcome in four general-practitioner obstetric units in isolated areas (Berwick, Whitby, Guernsey, and Brecon). All units were equipped to induce labour; to perform instrumental vaginal delivery and selected breech deliveries; and to remove placentas manually. All had some fetal monitoring equipment. Caesarean sections could not be performed at Berwick and Whitby. Proportions of normal deliveries during 1976-7 varied from 75% to 93%. Perinatal mortality was acceptably low, as were transfer rates for neonates and mothers in labour. With specialist help and particular attention to training and broadening local doctors'' experience of abnormal obstetrics, such units should be able to provide an excellent obstetric service.     

Triple touch sperm immobilization vs. single touch sperm immobilization in ICSI? - a randomised trial

ABSTRACT: BACKGROUND: Although different techniques for sperm immobilization have been described, their value has not been assessed in an adequately powered randomized study. The aim of this study was to compare two types of sperm immobilization methods prior to ICSI and to test the hypothesis that triple touch immobilization (TTIm) would lead to a higher (5% -65% up to 70%) fertilization rate (FR) than single touch immobilization (STIm). METHODS: A total of 3056 metaphase II (MII) oocytes, from 290 patients, were randomly assigned to the STIm group (n = 1528 oocytes; 145 cycles) or to the TTIm group (n = 1528 oocytes (TTIm group, 138 cycles). A total of 1478 oocytes (STIm group) and 1476 oocytes (TTIm group) were used in the statistical analysis. The primary outcome variable was FR. Secondary outcome variables included: number of good quality embryos (GQE) on day 2 and day 3, implantation rate (IR) and implantation with foetal heart beat rate (FHB). Statistical analysis was done using the Fisher Exact test with a significance level of 0.05. RESULTS: The results showed no differences in FR between both groups. The proportion of good quality embryos on day 3, was significantly higher in the STIm group (37.5%) compared to the TTIm group (31.8%; p = 0.02). CONCLUSIONS: In this RCT, the hypothesis that the post-ICSI FR would be higher after TTIm than after STIm was not confirmed and the number of good quality embryos on day 3 was significantly lower in the TTIm group than in the STIm group. These data suggest that more 'aggressive' TTIm technique has no advantages compared to the STIm technique.     

Can cognitive enhancers reduce the risk of falls in older people with Mild Cognitive Impairment? A protocol for a randomised controlled double blind trial

Background  

Older adults with cognitive problems have a higher risk of falls, at least twice that of cognitively normal older adults. The consequences of falls in this population are very serious: fallers with cognitive problems suffer more injuries due to falls and are approximately five times more likely to be admitted to institutional care. Although the mechanisms of increased fall risk in cognitively impaired people are not completely understood, it is known that impaired cognitive abilities can reduce attentional resource allocation while walking. Since cognitive enhancers, such as cholinesterase inhibitors, improve attention and executive function, we hypothesise that cognitive enhancers may reduce fall risk in elderly people in the early stages of cognitive decline by improving their gait and balance performance due to an enhancement in attention and executive function.     

Does informed consent influence therapeutic outcome? A clinical trial of the hypnotic activity of placebo in patients admitted to hospital.

To examine whether written informed consent might influence the results of clinical trials the effect of placebo when given with or without informed consent to patients suffering from insomnia was studied. The study was a single blind observer blinded trial, and patients were paired according to sex, age, and hospital environment. Randomisation assigned the first patient of each pair to the control group (without informed consent) or the group to give informed consent. Of the 56 patients, 26 refused to give informed consent, and the age and sex distribution of these differed significantly (p less than 0.02) from the 30 pairs of patients ultimately enrolled into the study. In this "biased" sample, the hypnotic activity of placebo was significantly higher in the control group (p less than 0.05). It is concluded that the informed consent procedure biases the results of clinical trials and might affect their general applicability.     

Procurement,commissioning and QA of AI based solutions: An MPE’s perspective on introducing AI in clinical practice

PurposeIn this study, we propose a framework to help the MPE take up a unique and important role at the introduction of AI solutions in clinical practice, and more in particular at procurement, acceptance, commissioning and QA.Material and methodsThe steps for the introduction of Medical Radiological Equipment in a hospital setting were extrapolated to AI tools. Literature review and in-house experience was added to prepare similar, yet dedicated test methods.ResultsProcurement starts from the clinical cases to be solved and is usually a complex process with many stakeholders and possibly many candidate AI solutions. Specific KPIs and metrics need to be defined. Acceptance testing follows, to verify the installation and test for critical exams. Commissioning should test the suitability of the AI tool for the intended use in the local institution. Results may be predicted from peer reviewed papers that treat representative populations. If not available, local data sets can be prepared to assess the KPIs, or ‘virtual clinical trials’ could be used to create large, simulated test data sets. Quality assurance must be performed periodically to verify if KPIs are stable, especially if the software is upscaled or upgraded, and as soon as self-learning AI tools would enter the medical practice.DiscussionMPEs are well placed to bridge between manufacturer and medical team and help from procurement up to reporting to the management board. More work is needed to establish consolidated test protocols.     

Can testing clinical significance reduce false positive rates in randomized controlled trials? A snap review

Objective

The use of minimum clinically important difference in the hypothesis formulation for superiority trials is similar in principle to the concept of non-inferiority or equivalence trial. However, most clinical trials are analysed testing zero clinical difference. Since the minimum clinically important difference is pre-defined for power calculation, it is important to incorporate it in both the hypothesis testing and the interpretation of findings from clinical trials.

Results

We reviewed a set of 50 publications (25 with binary outcome, and 25 with survival time outcome). 20% of the 50 published trials that were statistically significant, were also clinically significant based on the minimum clinically important risk differences (or hazard ratio) used for their power calculations. This snap review seems to suggest that most published trials with statistically significant results were less likely to be clinically significant, which may partly explain the high false positive findings associated with findings from superiority trials. Furthermore, none of the reviewed publications explicitly used minimum clinically important difference in the interpretation of their findings. However, a systematic review is needed to critically appraise the impact of the current practice on false positive rate in published trials with significant findings.

     

Can China achieve its 2020 carbon intensity target? A scenario analysis based on system dynamics approach

Since Chinese government put a target to decrease carbon intensity 40–45% in 2020 than that of 2005, a series of emission mitigation measures has been implemented. Against this backdrop, we established a system dynamics model to investigate the energy consumption, CO₂ emission and mitigation options in China. The results show that the carbon intensity will reduce by 22.68%, 26.84%, 43.77%, and 46.65% in BaU (Business as usual), NEP (New energy policy), CTP (Carbon tax policy) and IP (Integrated policy) scenarios in 2020 compared with 2005. Obviously, Chinese government can accomplish the target under CTP and IP scenarios. Moreover, the “inflection point” in CTP and IP scenarios reveals the decision-making process between tax burden and emission reduction behavior. A brief analysis of interactive effect is accomplished by equilibrium theory and simulation results. It shows that the interactive effect of two policies, which act on the same object with same action direction, is weaker than the aggregation of two separated effects, whereas it is larger than any individual effect. In a nutshell, these findings are helpful for policymakers to optimize their policy decision-making to cut CO₂ emissions.     

When does a clone deserve a name? A perspective on bacterial species based on population genetics.

Molecular population-genetic analysis has revealed that for several human diseases, including tuberculosis, plague and shigellosis, the generally accepted taxonomic status of the organisms involved does not fit the usually accepted genus or species criteria. This raises the question of what species concept to apply to bacteria. We suggest that the species definition in bacteria should be based on analysis of sequence variation in housekeeping genes, and also that the "clone" be given official status in bacterial nomenclature. This will allow demotion of the species or genus status of several traditionally recognized human pathogens, but retention of current names of anomalous species and genera as clone names.     

Are general practitioners doing enough to promote healthy lifestyle? Findings of the Medical Research Council's general practice research framework study on lifestyle and health.

The health survey questionnaire was used to collect information about cigarette smoking, alcohol consumption, physical exercise, and dieting and weight. Completed questionnaires were received from 25,496 men and 36,657 women registered with 47 group practices in England and Scotland. The proportions of respondents who stated that they had a problem ranged from 1% (women and drinking, n = 406) to 34% (women and weight, n = 12,526). Between 49% (women and drinking, n = 18,048) and 67% (men (n = 17,095) and women (n = 24,550) and weight) thought that their general practitioners should be interested in their lifestyle. The proportions who could recall having received relevant advice ranged from 2% (women and drinking, n = 591) to 24% (women and weight, n = 8946). Advice about smoking had been given to 4055 (40%) of the women and 2941 (39%) of the men who smoked. Only 96 (10%) of the 989 women and 331 (17%) of the 1948 men who drank excessively could recall having received advice about alcohol consumption. These results suggest that patients are concerned about their lifestyle, that most would welcome relevant counselling, and that doctors should become more concerned with prevention of this kind.     

Are the recommendations being met in the general practice year of vocational training? Trainees' views in the West Midlands region.

Vocational trainees in the West Midlands who were in their general practice year were sent a postal questionnaire to find out whether there were important differences between the criteria for training of the 1986 West Midland postgraduate education committee (based on national recommendations) and the perceptions of the trainees of their current trainers and practices. The response rate was 86.2% (75 out of 87). Sixty four per cent (48) of trainees reported that they received on average less than the recommended minimum of three hours of teaching time a week. They felt that experience was inadequate in paediatric surveillance (62.7%) and preventive medical care (37.3%). Most trainers gave topic teaching (90.7%), and few used role play (5%). Most of the trainees (52%) had not signed a contract, a third did not get help with recommended allowances, and 37% thought that their progress had not been reviewed. Several trainees commented on the excellence of their training practices, and most of the practices appeared to be keeping to the spirit of the recommendations. There are, however, discrepancies between what some trainees feel they receive and what is recommended.     

Determination of CO₂ sensitivity of micro-organisms in shaken bioreactors. I. Novel method based on the resistance of sterile closure

Influence of carbon dioxide on growth and product kinetics of industrially important micro-organisms is essential for the interpretation of a bioprocess. In this research, the CO? effects on productivity and growth rate of micro-organisms have been studied by using a variety of kplug. The applied method is based on a different concentration of CO? in the headspace of ventilation flasks. The presented method is simple, inexpensive and shows similar results compared to large-scale fermentation regarding the evolution of CO? in a batch system. For the investigation of the proposed method, experiments employing Arxula adeninivorans LS3, Corynebacterium glutamicum (DM1730 and ATCC WT13032) and Hansenula polymorpha DSM70277 as model organisms in the ventilation flasks are performed. The fermentations in the RAMOS (respiratory activity monitoring system) device were carried out with a normal aeration rate (1 vvm) and under the same operating conditions as the ventilation flask f1. The modified unsteady-state model was used to predict the operation conditions of a biological system in the ventilation flasks. In the present study, a novel and easy method for the quantification of CO? sensitivity of micro-organisms in shaken bioreactors (called ventilation flask) was achieved.     

A search method for homologs of small proteins. Ubiquitin-like proteins in prokaryotic cells?

The question of protein homology versus analogy arises when proteins share a common function or a common structural fold without any statistically significant amino acid sequence similarity. Even though two or more proteins do not have similar sequences but share a common fold and the same or closely related function, they are assumed to be homologs, descendant from a common ancestor. The problem of homolog identification is compounded in the case of proteins of 100 or less amino acids. This is due to a limited number of basic single domain folds and to a likelihood of identifying by chance sequence similarity. The latter arises from two conditions: first, any search of the currently very large protein database is likely to identify short regions of chance match; secondly, a direct sequence comparison among a small set of short proteins sharing a similar fold can detect many similar patterns of hydrophobicity even if proteins do not descend from a common ancestor. In an effort to identify distant homologs of the many ubiquitin proteins, we have developed a combined structure and sequence similarity approach that attempts to overcome the above limitations of homolog identification. This approach results in the identification of 90 probable ubiquitin-related proteins, including examples from the two prokaryotic domains of life, Archaea and Bacteria.