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Does teaching scald burn prevention to families of young children make a difference? A pilot study.

This article reports a pilot project designed to ascertain what scald burn prevention practices parents of young children used and whether teaching would lead to implementation of burn-related home-safety practices. The sample (n = 49) was followed up longitudinally, and participants completed a survey during two home interviews conducted at 4-week intervals. There was a statistically significant change in the number of scald burn prevention measures (p <.001) implemented by parents after public health nurses provided teaching. Changes in parental behavior were correlated with ethnicity (p <.05). The results have implications for teaching families effective scald burn prevention strategies.

Accidents, Home↗

Phase I trial of intramuscular injection of a recombinant adeno-associated virus alpha 1-antitrypsin (rAAV2-CB-hAAT) gene vector to AAT-deficient adults.

A recombinant virus vector constructed from adeno-associated virus (AAV) that has been altered to carry the human alpha1-antitrypsin (hAAT) gene expressed from a hybrid chicken beta-actin promoter with a cytomegalovirus enhancer has been developed. The construct has been shown to initiate the production of hAAT in animal models closely matching the proposed human trial. The proposed clinical trial is an open-label, phase I study administering recombinant adeno-associated virus alpha1-antitrypsin (rAAV2-CB-hAAT) gene vector intramuscularly to AAT-deficient human subjects where gene expression can be measured directly in blood samples to assess safety. Safety parameters will be measurement of changes in serum chemistries and hematology, urinalysis, pulmonary function testing, semen assay for vector genomes, immunologic response to AAT, and AAV, as well as reported subject history of any symptoms.

Adult↗

Accidental iatrogenic pneumothorax in hospitalized patients.

OBJECTIVE: Iatrogenic pneumothorax (IP) is an inherent risk to patients who undergo procedures that involve the intentional puncturing of the lung. IP also could occur accidentally to patients who do not undergo such procedures; such accidental IP (AIP) is suggestive of lapses in safe care. This study assessed the risk for AIP in patients hospitalized with specific diagnoses who underwent specific procedures. RESEARCH DESIGN: We analyzed 7.5 million discharge abstracts from 994 short-term acute care hospitals across 28 states in 2000 in the Agency for Healthcare Research and Quality (AHRQ), Healthcare Cost and Utilization Project Nationwide Inpatient Sample. AHRQ Patient Safety Indicators (PSIs) were used to identify AIP. AIP incidences and associated diagnoses and procedures were explored. RESULTS: Patients who were admitted for pleurisy, cancer of the kidney and renal pelvis, or conduction disorders and complications of cardiac devices had the highest rates of developing AIP during hospitalization, with AIP rates at 2.24%, 1.14%, and 0.83% respectively. The procedure-specific rates for AIP varied from 2.68% for patients who underwent thoracentesis to 1.30% for those who underwent nephrectomy, to 0.06% for those who underwent gastrostomy. Thoracentesis appeared to be a high-risk procedure for patients who were admitted for secondary malignancies, pleurisy, or pneumonia, with AIP rates at 3.76%, 3.13%, and 2.28%, respectively. CONCLUSIONS: Although AIP is most common after thoracentesis, it is a substantial threat to patients undergoing a wide range of procedures.

Hospitals↗

The use of child safety restraints with nursery furniture.

In Australia, nursery furniture is associated with just over 6% of all injuries to children between birth and 3 years of age and 19% (or almost one in five) of all injuries in the first year of life. In the case of injury associated with prams or strollers and high chairs, the vast majority of injuries occur as the result of falls (75 and 83% respectively). Interviews with parents whose children suffered an injury as a result of a fall from a pram or stroller or from a high chair indicate that only a small proportion of the children (28 and 25% respectively) were wearing any form of safety restraint prior to their injury despite the fact that, in both samples, the percentage of safety restraints fitted was about 80%. The potential for serious injury from such falls is great as most injuries in both groups (96 and 75% respectively) were to the head. One death associated with a stroller and one death as a result of a fall from a high chair have been recorded for Victoria between 1985 and 1988. In the absence of mandatory requirements for the design and manufacture of nursery furniture, there is a need to provide information about nursery furniture safety to parents and care-givers through nursery furniture retailers and through maternity hospitals and child health centres. In particular, the promotion of the correct use of an appropriate and effective child restraint is a relatively simple and inexpensive measure that could prevent up to 80% of all injuries associated with the three items of nursery furniture most often related to injury: strollers or prams, high chairs and change tables.

Accidental Falls↗

The incidence of complications associated with retrobulbar injection of anaesthetic for ophthalmic surgery.

A retrospective study of the incidence of complications associated with the use of retrobulbar injections was carried out on a sample of 1083 consecutive patients. The overall incidence of retrobulbar haemorrhage (1.3%) compared favourably with previous reports, but was found to be related to the experience of the surgeon. None of the more serious ocular complications of retrobulbar injection occurred in this sample. The relative safety of this technique is discussed.

Aged↗

Rapid and specific detection of Salmonella spp. in animal feed samples by PCR after culture enrichment.

A PCR procedure has been developed for routine analysis of viable Salmonella spp. in feed samples. The objective was to develop a simple PCR-compatible enrichment procedure to enable DNA amplification without any sample pretreatment such as DNA extraction or cell lysis. PCR inhibition by 14 different feed samples and natural background flora was circumvented by the use of the DNA polymerase Tth. This DNA polymerase was found to exhibit a high level of resistance to PCR inhibitors present in these feed samples compared to DyNAzyme II, FastStart Taq, Platinum Taq, Pwo, rTth, Taq, and Tfl. The specificity of the Tth assay was confirmed by testing 101 Salmonella and 43 non-Salmonella strains isolated from feed and food samples. A sample preparation method based on culture enrichment in buffered peptone water and DNA amplification with Tth DNA polymerase was developed. The probability of detecting small numbers of salmonellae in feed, in the presence of natural background flora, was accurately determined and found to follow a logistic regression model. From this model, the probability of detecting 1 CFU per 25 g of feed in artificially contaminated soy samples was calculated and found to be 0.81. The PCR protocol was evaluated on 155 naturally contaminated feed samples and compared to an established culture-based method, NMKL-71. Eight percent of the samples were positive by PCR, compared with 3% with the conventional method. The reasons for the differences in sensitivity are discussed. Use of this method in the routine analysis of animal feed samples would improve safety in the food chain.

Animal Feed↗

Lost working days, productivity, and restraint use among occupants of motor vehicles that crashed in the United States.

BACKGROUND: In 2001, 6.3 million passengers were involved in motor vehicle crashes. This study aimed to determine the number of work days lost as a result of motor vehicle crashes and factors that influenced people's return to work. METHODS: This was a retrospective, population based cohort study of occupants in motor vehicles involved in crashes from the 1993-2001 Crashworthiness Data System produced by the National Highway Traffic Safety Administration. The sample population of people aged 18-65 years included two groups: occupants who survived and were working before the crash and occupants who were injured fatally and were estimated to have been working before the crash. Multivariate linear regression was used to analyze the impact of restraint use and injury type on return to work. RESULTS: Overall, 30.1% of occupants of vehicles that crashed missed one or more days of work. A crash resulted in a mean 28.0 (95% confidence interval 15.8 to 40.1) days lost from work, including losses associated with fatalities. The 2.1 million working occupants of vehicles that crashed in 2001 lost a total of 60 million days of work, resulting in annual productivity losses of over $7.5 billion (2964 to 12 075). Unrestrained vehicle occupants accounted for $5.6 billion in lost productivity. CONCLUSIONS: Motor vehicle crashes result in large and potentially preventable productive losses that are mostly attributable to fatal injuries.

Accidents, Traffic↗

"Any other comments?" Open questions on questionnaires - a bane or a bonus to research?

BACKGROUND: The habitual "any other comments" general open question at the end of structured questionnaires has the potential to increase response rates, elaborate responses to closed questions, and allow respondents to identify new issues not captured in the closed questions. However, we believe that many researchers have collected such data and failed to analyse or present it. DISCUSSION: General open questions at the end of structured questionnaires can present a problem because of their uncomfortable status of being strictly neither qualitative nor quantitative data, the consequent lack of clarity around how to analyse and report them, and the time and expertise needed to do so. We suggest that the value of these questions can be optimised if researchers start with a clear understanding of the type of data they wish to generate from such a question, and employ an appropriate strategy when designing the study. The intention can be to generate depth data or 'stories' from purposively defined groups of respondents for qualitative analysis, or to produce quantifiable data, representative of the population sampled, as a 'safety net' to identify issues which might complement the closed questions. SUMMARY: We encourage researchers to consider developing a more strategic use of general open questions at the end of structured questionnaires. This may optimise the quality of the data and the analysis, reduce dilemmas regarding whether and how to analyse such data, and result in a more ethical approach to making best use of the data which respondents kindly provide.

Data Interpretation, Statistical↗

[Preliminary studies on process and ultramicro-pulverization on pharmacodynamics of Leech].

OBJECTIVE: To compare pharmacodynamics of decoction and powder of Leech; To identify effect of pharmacodynamics of Leech with new methods of process and ultrmicro-pulverization. METHOD: The size of ultramicor-powder of Leech and new method processed Leech is determined by BT-1500 size distributive instrument. It is compared that the pharmacodynamics of Leech decoction and powder as well as ultramicro-powder with new method processed of 1/2 decoction dose by anticoagulation and antithrombus action of mice. The safety of different samples is identified. RESULT: The pharmacodynamics of samples is as ultramicro-powder of Leech with new method processed > ultrmicro-powder of Leech > powder of Leech > decoction of Leech. CONCLUSION: The ultramicro-powder of Leech with new method processed has better pharmacodynamic effect and the smell of Leech is improved.

Animals↗

[Analysis of paralytic shellfish poisoning and diarrhetic shellfish poisoning of bivalves in seafood market of Guangzhou].

OBJECTIVE: Paralytic shellfish poisoning (PSP) and diarrhetic shellfish poisoning (DSP) in 7 species of economical shellfishes were analyzed for 1 year, which collected from Huangsha seafood market of Guangzhou from Apr, 2004 to Mar, 2005. METHODS: The levels of PSP and DSP in bivalves were determined with mouse bioassay of AOAC. The risk assessment of PSP and DSP in bivalves was conducted according to FAO and Chinese Administration Organization of Fish Culture and Seaport. RESULTS: PSP was detected in 2 species of the shellfishes assayed and DSP was found out in 6 species. The content of PSP was lower than 4MU/g tissue, whereas the level of PSP in glands was higher than in muscles. DSP toxin was detected in 36 samples of 6 species, what is more, DSP level in 10 samples exceeded the safety threshold. The levels in PSP and DSP of bivalves were all higher in spring and winter with some characteristic of season. CONCLUSION: The results suggested that PSP in economical shellfish in Guangzhou market was lower, and shellfish was safe to eat in term of the PSP level if glands were discarded, but DSP contamination in bivalves was severe. It is essential to detect and assess the risk of DSP and PSP in bivalves from seafood market in the future.

Animals↗

[Creation of an experimental cell culture vaccine against distemper using cell line 4647].

Experiment in susceptible animals demonstrated the effectiveness and safety of several samples of a distemper vaccine prepared in cell line 4647. Preparations of the vaccine virus variants generated in line 4647 after 10 passages at 34 degrees C, 37 degrees C and 40 degrees C and 20 passages of rapidly multiplying virus (34 degrees C) possessed the protective activity when used for immunization in a dose of 1000 PFU/animal. The results obtained in observations of the animals and examinations of sera for antibodies did not differ from those of control tests of "Vakchum".

Animals↗

Percutaneous ultrasound-guided fetal blood sampling: experience in the first 100 cases.

Percutaneous ultrasound-guided fetal blood sampling was performed on 100 pregnancies with various fetal problems. Our technique involved the use of a 45 degree needle guide attached to a sector probe. Their gestational ages ranged from 17-38 weeks, mostly over 20-35 weeks. Seventy percent of cases were successful at the first sampling and 33% of cases had bleeding from the punctured cord. In 43 cases, a positive diagnosis was established after ultrasound-guided fetal blood sampling, including 25 Hemoglobin Bart's hydrops fetalis, 2 beta-thalassemia major, 1 hemophilia, 1 rubella infection, 1 syphilis and 13 chromosome aberrations. There were 33 survivors in this series. Seven anomalous fetuses ended in intrauterine deaths. Sixty cases resulted in neonatal deaths after spontaneous or induced labors. No fetal loss occurred in 25 normal fetuses. One fetal loss was probably related to the procedure (fetal loss rate 1/100). No immediate fetal death after sampling procedure was noted. In conclusion, ultrasound-guided fetal blood sampling had reasonable safety and technical feasibility. More common use of this technique in fetal investigations is justified and expected.

Blood Specimen Collection↗

[Autoimmune thrombopenia and pregnancy. Value of counting scalp platelets].

Fetuses of mothers who have auto-immune thrombocytopenia are at risk in utero of having transitory thrombocytopenia. There is no maternal biological test that can predict the numbers of platelets in the fetus. This count of platelet numbers can be estimated from taking fetal blood from the scalp at the onset of labour, and if the count is less than 50 X 10(9) per litre a caesarean operation is indicated. The authors report a series of 23 pregnancies where the mother had auto-immune thrombocytopenia and where fetal scalp blood sampling was indicated. This series has been compared with a previous series of 14 pregnancies where scalp sampling was not carried out. There was no case of severe fetal thrombocytopenia after scalp sampling was carried out and where the best way of delivery could be predicted early enough in each case. The ease of taking the sample and the safety and reliability of it for estimating the degree of thrombocytopenia in the fetus and thus deciding the method of delivery makes us believe that this method should be used more frequently in cases of maternal thrombocytopenia that appear late in pregnancy.

Autoimmune Diseases↗

[Multicenter double-blind comparison of auranofin and Tauredon].

A multicenter double-blind comparative study with auranofin (Ridaura) and Na-auro-thiomalate (Tauredon) was carried out in order to investigate under controlled conditions whether the new oral gold compound may be an alternative to injections of gold salts. 121 patients were included in the study, data of 86 patients treated for at least one year could be analysed. The following parameters were examined at regular intervals: number of painful and swollen joints, grip strength, morning stiffness, pain and general health on the visual analogue scale, ESR; from these data the articular index and activity index (according to Lansbury, with slight modifications) were calculated. Blood samples for routine safety monitoring and serum gold levels as well as urine tests were obtained regularly. Both treatment groups showed similar improvement in the values for efficacy measurements after one year, starting within 8 to 12 weeks. Patients in the auranofin group with a disease duration of less than 2 years showed greater improvement in the values for efficacy assessment with the exception of grip strength and the number of tender joints than patients with a disease duration of 2 years or more. No such trend was seen in the Tauredon-subgroups. Numerous side effects were recorded in both groups: 89.7% of the patients on Tauredon and 68.8% of the patients on auranofin had observed one symptom during the course of one year. There was a clear distinction concerning the nature of side effects: mucocutaneous symptoms, especially rash and pruritus, were approximately twice as common with Tauredon, whereas diarrhoea was much more frequent in patients treated with auranofin.(ABSTRACT TRUNCATED AT 250 WORDS)

Anti-Inflammatory Agents↗

Amitriptyline-perphenazine and doxepin in depressed outpatients: a controlled double-blind study.

Amitriptyline-perphenazine (100/8-150/12 mg/day) and doxepin (100-150 mg/day) were compared for clinical efficacy and safety in a sample of 130 nonpsychotic depressed outpatients. Maximum study duration was 4 weeks; 19 amitriptyline-perphenazine and 29 doxepin patients completed less than or equal to 3 weeks of treatment and 45 amitriptyline-perphenazine and 37 doxepin patients completed 4 weeks of treatment. Patients in both groups showed significant improvement in depression, but amitriptyline-perphenazine produced greater improvement than doxepin on several measures of depressive symptomatology. The incidence of anticholinergic and sedative side effects was higher in the amitriptyline-perphenazine treated group.

Adult↗

Pharmacokinetic development of quinolone antibiotics.

A prerequisite for the pharmacokinetic development of quinolone antibiotics is a sensitive and accurate method for the quantification of the drug in biological fluids. Both, a drug specific (e.g. HPLC) and a drug non-specific but effect related assay (e.g. bioassay) should be used during early clinical development to detect major active metabolites. The basic pharmacokinetic behavior of the drug is investigated as part of the early phase I program, where single and multiple ascending dose studies are performed to characterize the safety and tolerability of the quinolone in healthy volunteers. Further pharmacokinetic studies are performed to describe the absolute bioavailability, dose proportionality, pharmacokinetics in young and elderly, male and female volunteers. The suitability of the clinical dosage from must be evaluated in comparison to an oral solution and by quantification of the effect of food on bioavailability. The characterization of the absorption in different parts of the gastrointestinal tract may be valuable for dosage form optimization. In order to start phase IIb clinical trials, the potential of possible drug-drug interactions with antacids, cimetidine, theophylline and warfarin has to be evaluated. This can be done by in vitro and in vivo preclinical experiments, before formal clinical-pharmacology studies are performed. Further pharmacokinetic characterization (e.g. studies in special subpopulation, extended interaction studies, total recovery using 14C-labelled compound, blister fluid penetration) will be done parallel to the phase II/III development program. During these efficacy and safety trials blood samples should be obtained and PK-parameters can be calculated using sparse data analysis methods like non-linear mixed effect modeling (NONMEM) or Bayesian methods to characterize the pharmacokinetics in the target population.

4-Quinolones↗

Treatment of HIV-related fluconazole-resistant oral candidosis with D0870, a new triazole antifungal.

OBJECTIVES: To evaluate the efficacy and tolerance of D0870 in the treatment of HIV-related fluconazole-resistant oro-oesophageal candidosis. DESIGN: Multicentre open study. PATIENTS: HIV-seropositive patients with oro-oesophageal candidosis despite at least 7 days of treatment with fluconazole at doses of 100 mg per day or more. METHODS: Patients received an initial dose of D0870 (150 mg), then 25 mg per day for 6 days. Symptoms and signs of candidosis were compared at entry and on days 3 and 7 of treatment. At each visit, samples were taken for safety monitoring and for in vitro susceptibility testing of Candida isolates. Limited pharmacokinetic samples were taken on days 1 and 7. RESULTS: Of 26 evaluable patients, 16 showed partial improvement, nine showed no improvement, and only one had full clearance of thrush by day 7. In vitro testing of the cleared patient's isolate suggested that it was susceptible to fluconazole. Symptoms of dysphagia cleared in 14 and improved in five of the 22 patients with presumptive oesophageal involvement at entry. Pharmacokinetic measurement showed wide variability in maximum D0870 levels recorded on day 1 (range, 0.07-0.34 mg/l) and susceptibility testing of isolates also showed a range of minimal inhibitory concentration values to D0870 (range, < 0.06-8 mg/l; median, 0.25 mg/l). When these data were combined with clinical response there was a strong suggestion that lack of symptomatic improvement was related to low plasma D0870 levels or to the presence of less D0870-susceptible isolates. Six patients were noted to have a fall in haemoglobin, three of whom were receiving concomitant therapy known to suppress bone marrow. Three patients reported headaches as adverse events that were attributed to study medication, but D0870 was well tolerated overall. CONCLUSIONS: D0870 shows promise in the treatment of fluconazole-resistant oro-oesophageal candidosis and was well tolerated, although efficacy in this difficult-to-treat patient group was probably limited due to the inadequate plasma levels achieved in this pilot study with the low doses of D0870 administered.

AIDS-Related Opportunistic Infections↗

Can mothers safely prepare labon-gur salt-sugar solution after demonstration in a diarrhoeal hospital?

Home-based salt-sugar solution (SSS) prepared with labon (locally produced sea salt) and gur (unrefined brown sugar) has been recommended as a cheap, locally available and a simple tool to prevent and treat diarrhoeal dehydration. Preparation of labon-gur SSS is demonstrated to the patients and the attendants at ICDDR, Bangladesh. To evaluate performances, 150 mothers were asked to measure labon and gur by finger pinch and first method and 100 mothers measured half a seer of water to prepare labon-gur SSS, shortly after the demonstration sessions. 4.0% of the samples exceeded the upper safety limit while 1.3% exceeded the upper danger limit for salt and 98.7% samples of gur were within safe and effective range. Mothers' performances were not different with regard to their educational status and prior practice at home. 80% knew about the solution before coming to the hospital and 45% had utilized this knowledge. Our study suggests that demonstration of home-based SSS in a diarrhoeal hospital may positively affect health education and that health personnel should actively participate in increasing health awareness.

Bangladesh↗