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H1-antihistamines for the treatment of anaphylaxis: Cochrane systematic review.
BackgroundAnaphylaxis is an acute systemic allergic reaction, which can be life-threatening. H(1)-antihistamines are commonly used as an adjuvant therapy in the treatment of anaphylaxis. We sought to assess the benefits and harm of H(1)-antihistamines in the treatment of anaphylaxis.MethodsWe searched the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library); MEDLINE (1966 to June 2006); EMBASE (1966 to June 2006); CINAHL (1982 to June 2006) and ISI Web of Science (1945 to July 2006). We also contacted pharmaceutical companies and international experts in anaphylaxis in an attempt to locate unpublished material. Randomized and quasi-randomized-controlled trials comparing H(1)-antihistamines with placebo or no intervention were eligible for inclusion. Two authors independently assessed articles for inclusion.ResultsWe found no studies that satisfied the inclusion criteria.ConclusionsBased on this review, we are unable to make any recommendations for clinical practice. Randomized-controlled trials are needed, although these are likely to prove challenging to design and execute.
Action plans for the long-term management of anaphylaxis: systematic review of effectiveness.
BackgroundAnaphylaxis is a severe, potentially life-threatening allergic reaction. Most reactions occur in the absence of a healthcare professional and there is a considerable risk of recurrence in those with a past history of anaphylaxis. The concept of action plans has been developed to facilitate long-term self-management of chronic disorders with a view to promoting patient empowerment and improving health outcomes. Although increasingly advocated for use in anaphylaxis, the effectiveness of this approach in this context is unknown.ObjectivesTo assess the effectiveness of action plans as part of the long-term self-management of anaphylaxis in improving health outcomes.MethodsStandard systematic review techniques were used. We searched CENTRAL, Cochrane, Medline and Embase databases, contacted an international panel of anaphylaxis experts and relevant pharmaceutical companies and searched key web-based databases of trials (http://www.clinicaltrials.gov, http://www.controlledtrials.com and http://www.nrr.nhs.uk) for published, unpublished and on-going randomized or quasi-randomized controlled trials of action plans in anaphylaxis management. There was no restriction used with respect to the language of publication. Searches were completed in summer 2006.ResultsNone of the 1026 potentially relevant studies identified fulfilled the inclusion criteria for this review.ConclusionsAlthough there are potential major benefits of routinely issuing anaphylaxis action plans, there is currently no robust evidence to guide clinical practice. Pragmatic randomized-controlled trials of anaphylaxis action plans are urgently needed; in the meantime, national and international guidelines should make clear this major gap in the evidence base.
Is there any role for allergen avoidance in the primary prevention of childhood asthma?
In this article we discuss 3 hypotheses to attempt to understand why preventive measures thus far studied with the aim of preventing (or delaying) the development of asthma have shown such disappointing results. The most likely explanation is that the development of a multifactorial disease, such as asthma, is extremely difficult, if not impossible, to prevent by eliminating only one risk factor. In a meta-analysis we investigated the effect of a multifaceted and monofaceted intervention in 10 prospective birth cohorts of a total of 3473 children on a diagnosis of asthma. Multifaceted intervention studies had an odds ratio (OR) of 0.73 (95% CI, 0.55-0.97), whereas the monointervention studies had an OR of 1.22 (95% CI, 0.83-1.78) in patients younger than 5 years and an OR of 0.52 (95% CI, 0.32-0.84) versus 0.93 (95% CI, 0.66-1.31) in patients older than 5 years. We therefore hypothesize that studies with a multifaceted approach will have a much greater chance of being successful than studies using a monofaceted approach, with the latter being unlikely to yield a clinically relevant reduction of asthma.
The Department of Health's research governance framework remains an impediment to multi-centre studies: findings from a national descriptive study.
ObjectiveWe describe our experience of using the standard application form, designed to streamline applications for multi-centre research, to seek approval from all primary care organizations (PCOs) in England and Wales to undertake a single telephone interview with a health service manager.DesignWe sent applications (n=316), by email to each PCO, or consortium of PCOs, attaching a completed standard application form, the 15 required documents, and the approval we had been granted by the lead NHS organization. We maintained detailed records of the responses to our application, subsequent correspondence, additional paperwork requested, and time spent on the approval process.SettingThe UK Research Governance Framework, which regulates all research conducted in health and social care settings.ParticipantsAll PCOs in England and Wales.InterventionsNone.Main outcome measuresTime taken to obtain approval to undertake a telephone interview with a health service manager.ResultsWe were unable to establish contact with 13 (4%) PCOs. Six months after submitting our application we had received approval from 259/316 (82%) PCOs and were still awaiting a verdict from 41 (13%). The median time to approval was 56 days (IQR 42-72). Overall, an estimated 318 staff-hours were spent completing supplementary forms, providing additional information and chasing up dormant applications.ConclusionsRecent initiatives to 'streamline' research governance approval have failed to address the problems that face researchers undertaking multi-centre studies. There is an urgent need to develop a simpler process that allows low risk research to take place without threatening staff morale and endangering the quality of the research outputs. In the meantime, we advise researchers to allow far greater time than might reasonably be envisioned to obtain research governance approval.
Understanding the potential role of mobile phone-based monitoring on asthma self-management: qualitative study.
BackgroundNational and international healthcare policy increasingly seeks technological solutions to the challenge of providing care for people with long-term conditions. Novel technologies, however, have the potential to change the dynamics of disease monitoring and self-management. We aimed to explore the opinions and concerns of people with asthma and primary care clinicians on the potential role of mobile phone monitoring technology (transmitting symptoms and peak flows, with immediate feedback of control and reminder of appropriate actions) in supporting asthma self-management.MethodsThis qualitative study recruited 48 participants (34 adults and teenagers with asthma, 14 asthma nurses and doctors) from primary care in Lothian (Central Scotland) and Kent (South East England). Thirty-nine participated in six focus groups, which included a demonstration of the technology; nine gave in-depth interviews before and after a 4-week trial of the technology.ResultsParticipants considered that mobile phone-based monitoring systems can facilitate guided self-management although, paradoxically, may engender dependence on professional/technological support. In the early phases, as patients are learning to accept, understand and control their asthma, this support was seen as providing much-needed confidence. During the maintenance phase, when self-management predominates, patient and professionals were concerned that increased dependence may be unhelpful, although they appreciated that maintaining an on-going record could facilitate consultations.ConclusionMobile phone-based monitoring systems have the potential to support guided self-management by aiding transition from clinician-supported early phases to effective self-management during the maintenance phase. Continuing development, adoption and formal evaluation of these systems should take account of the insights provided by our data.
Seasonal allergic rhinitis in adolescents and adults.
IntroductionSeasonal allergic rhinitis is found throughout the world. Epidemiological evidence suggests that there is considerable geographical variation in its prevalence. Symptoms are caused by an IgE mediated type 1 hypersensitivity reaction to air-borne allergens such as pollen or fungal spores, and may also cause eye, respiratory, and systemic problems.Methods and outcomesWe conducted a systematic review and aimed to answer the following clinical question: What are the effects of treatments for seasonal allergic rhinitis in adolescents and adults? We searched: Medline, Embase, The Cochrane Library and other important databases up to September 2005 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).ResultsWe found 165 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.ConclusionsIn this systematic review we present information relating to the effectiveness and safety of the following interventions: astemizole, intranasal azelastine, intranasal corticosteroids, intranasal ipratropium bromide, intranasal levocabastine, oral antihistamines, oral decongestants, oral leukotriene receptor antagonists, pseudoephedrine, systemic corticosteroids, terfenadine.
Key challenges and ways forward in researching the "good death": qualitative in-depth interview and focus group study.
ObjectiveTo understand key challenges in researching end of life issues and identify ways of overcoming these.DesignQualitative study involving in-depth interviews with researchers and focus groups with people affected by cancer.ParticipantsAn international sample of 32 researchers; seven patients with experience of cancer; and four carers in south east Scotland.ResultsResearchers highlighted the difficulty of defining the end of life, overprotective gatekeeping by ethics committees and clinical staff, the need to factor in high attrition rates associated with deterioration or death, and managing the emotions of participants and research staff. People affected by cancer and researchers suggested that many people nearing the end of life do want to be offered the chance to participate in research, provided it is conducted sensitively. Although such research can be demanding, most researchers believed it to be no more problematic than many other areas of research and that the challenges identified can be overcome.ConclusionsThe continuing taboos around death and dying act as barriers to the commissioning and conduct of end of life research. Some people facing death, however, may want to participate in research and should be allowed to do so. Ethics committees and clinical staff must balance understandable concern about non-maleficence with the right of people with advanced illness to participate in research. Despite the inherent difficulties, end of life research can be conducted with ethical and methodological rigour. Adequate psychological support must be provided for participants, researchers, and transcribers.
Undergraduate allergy teaching in a UK medical school: comparison of the described and delivered curriculum.
BackgroundConcerns have been raised about the adequacy of allergy teaching in UK undergraduate medical curricula. Our previous work, which involved undertaking a systematic analysis of the documented curricular learning objectives relating to allergy teaching in a UK medical school, found references to allergy teaching in each of the five years of study but also identified some apparent omissions in allergy teaching. These may represent actual gaps in relation to allergy training, or alternatively may reflect dissonance between the described and delivered curricula.ObjectiveTo compare the described and delivered undergraduate curricula on allergy and allergy-related topics in a UK medical school.MethodsWe identified and e-mailed the individuals responsible for each of the 43 modules in the five-year undergraduate medical programme at the University of Edinburgh, enquiring about the delivery of allergy-related teaching within their modules. We then compared these responses with the results of the previous study mapping allergy-related teaching across the undergraduate curriculum.ResultsFifty-one individuals were identified as being responsible for leading the 43 modules in the curriculum. Forty-nine (96%) of these module organisers responded to our enquiry; these individuals represented 41 of the 43 modules (95%). Module organisers reported that allergy-related teaching and learning was delivered in 14 modules (33%), was absent in 13 (30%) modules, and may occur to varying degrees within a further 10 (23%) modules. Module organisers' responses about the delivered curriculum on allergy were consistent with the findings from documented learning objectives in 21 (49%) modules. They also reported allergy teaching and learning in modules which had not been identified by examination of the learning objectives; however, there were still important gaps in the allergy-related curriculum.ConclusionsInformation gathered from teaching staff confirms that specific teaching and learning on allergic disorders is currently being delivered in all five years of the undergraduate curriculum. However, comparison between the described and delivered curricula on allergy revealed discrepancies highlighting the complex nature of the undergraduate curriculum and the difficulties involved in mapping specific teaching themes within them. This assessment has revealed gaps in allergy training which need to be addressed.
Improving general practice computer systems for patient safety: qualitative study of key stakeholders.
ObjectiveThe authors sought to identify ways in which the use of general practice computer systems could be improved to enhance safety in primary care.DesignQualitative study using semistructured interviews.ParticipantsThirty one participants, representing a broad range of relevant disciplines and interest groups. Participants included clinicians, computer system and drug database suppliers, academics with interests in health informatics and members of governmental, professional and patient representative bodies.SettingUK.ResultsParticipants identified deficiencies in current systems that pose serious threats to patient safety. To bring about improvements, providers need to supply clinicians with safe, accurate and accessible information for decision support; be aware of the importance of human ergonomics in the design of hazard alerts; consider the value of audit trails and develop mechanisms to allow for the accurate transfer of information between clinical computer systems. These improvements in computer systems will be most likely to occur if mandated through regulations. Individual practices are in need of improved education and training which focuses, in particular, on providing support with recording data accurately and using call, recall and reminders effectively.ConclusionThere are significant opportunities for improving the safety of general practice computer systems. Priorities include improving the knowledge base for clinical decision support, paying greater attention to human ergonomics in system design, improved staff training and the introduction of new regulations mandating system suppliers to satisfy essential safety requirements.
Neuraminidase inhibitors for preventing and treating influenza in children.
BackgroundDuring epidemic years, influenza attack rates in children exceed 40%. Options for prevention and treatment include the neuraminidase inhibitors: zanamivir and oseltamivir.ObjectivesTo assess the efficacy, safety and tolerability of neuraminidase inhibitors in the treatment and prevention of influenza infection in children.Search strategyWe searched the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 1, 2005); MEDLINE (1966 to April 2005); EMBASE (January 1980 to December 2004); the on-line GlaxoSmithKline Clinical Trials Register; the on-line Roche Clinical Trial Protocol Registry and Clinical Trial Results Database (August 2005); and reference lists of articles. We also scrutinised web sites of European and US regulatory bodies and contacted manufacturers and authors.Selection criteriaDouble-blind, randomised, controlled trials comparing neuraminidase inhibitors with placebo or other antiviral drugs in children less than 12 years of age. Additional safety and tolerability data from other sources were also included.Data collection and analysisFour authors applied the inclusion criteria to the retrieved studies, assessed trial quality and extracted data. Data were analysed separately for oseltamivir and zanamivir.Main resultsThree trials involving 1500 children with a clinical case definition of influenza were included, of whom 977 had laboratory-confirmed influenza. Overall, trial quality was good. Oseltamivir reduced the median duration of illness by 26% (36 hours) in healthy children with laboratory-confirmed influenza (P value less than 0.0001). The reduction was only 7.7% (10 hours) in 'at risk' (asthmatic) children, and this did not reach statistical significance (P value = 0.54). Zanamivir reduced the median duration of illness by 24% (1.25 days) in healthy children with laboratory-confirmed influenza (P value less than 0.001). No data in 'at risk' children were available. Only oseltamivir produced a significant reduction in the complications of influenza (particularly otitis media), although there was a trend to benefit for zanamivir. We identified one randomised, controlled trial of oseltamivir for the prevention of influenza transmission in households, reporting data from 222 paediatric contacts. Where index cases had laboratory-confirmed influenza, a protective efficacy of 55% was observed, but this did not reach statistical significance (P value = 0.089). The adverse events profile of zanamivir was no worse than placebo, but vomiting was more common in children treated with oseltamivir.Authors' conclusionsNeuraminidase inhibitors are effective in shortening illness duration in healthy children with influenza, but efficacy in 'at risk' children remains to be proven. Oseltamivir is also effective in reducing the incidence of secondary complications, and may be effective for influenza prophylaxis.
H1-antihistamines for the treatment of anaphylaxis with and without shock.
BackgroundAnaphylaxis is an acute systemic allergic reaction, which can be life-threatening. H1-antihistamines are commonly used as an adjuvant therapy in the treatment of anaphylaxis.ObjectivesTo assess the benefits and harm of H1-antihistamines in the treatment of anaphylaxis.Search strategyWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), (The Cochrane Library), MEDLINE (1966 to June 2006);EMBASE (1966 to June 2006); CINAHL (1982 to June 2006) and ISI Web of Science (1945 to July 2006). We also contacted pharmaceutical companies and international experts in anaphylaxis in an attempt to locate unpublished material.Selection criteriaRandomized and quasi-randomized controlled trials comparing H1-antihistamines with placebo or no intervention.Data collection and analysisTwo authors independently assessed articles for inclusion.Main resultsWe found no studies that satisfied the inclusion criteria.Authors' conclusionsBased on this review, we are unable to make any recommendations for clinical practice. Randomized controlled trials are needed, although these are likely to prove challenging to design and execute.
House dust mite avoidance measures for perennial allergic rhinitis.
BackgroundIn developed countries, it is estimated that approximately 30% of the general population suffer from one or more allergic disorders, of which allergic rhinitis is the most common. Perennial rhinitis is most often due to allergy to the house dust mite. In such patients, house dust mite avoidance is logical, but there is considerable uncertainty regarding the efficacy and effectiveness of interventions designed to reduce dust mite exposure.ObjectivesTo assess the benefit (and harm) of measures designed to reduce house dust mite exposure in the management of house dust mite sensitive allergic rhinitis.Search strategyOur search included the Cochrane Ear, Nose and Throat Disorders Group Trials Register, the Cochrane Central Register of Controlled Trials Register (CENTRAL) (The Cochrane Library, Issue 2, 2005), MEDLINE (1951 to 2005) and EMBASE (1974 to 2005). No restrictions on the language of publication were employed. The bibliography of each paper and other published reviews were checked for further references. The date of the last search was May 2005.Selection criteriaRandomised controlled trials (with or without blinding), in which house dust mite control measures have been evaluated in comparison with placebo or other dust mite avoidance measures, in patients with clinician diagnosed allergic rhinitis and confirmed allergy to dust mite.Data collection and analysisTwo authors independently checked titles and abstracts identified by the searches and full text copies of all papers of potential relevance were considered. Trials were graded for methodological quality using the Cochrane approach. Data extraction was performed in a standardised manner. Meta-analysis was neither possible nor appropriate, because of the heterogeneity of the patient groups studied; a narrative overview of the results is therefore presented.Main resultsSeven trials satisfied the inclusion criteria. Of these, only two studies investigating the effectiveness of mite impermeable bedding covers were of good quality; the remaining five studies were small and of poor quality. Two trials investigated the efficacy of acaricides, another two trials investigated the role of high-efficiency particulate air filters; the remaining three trials investigated the efficacy of bedroom environmental control programmes involving use of house dust mite impermeable bedding covers. Six of the seven trials showed that the interventions result in significant reductions in house dust mite load when compared with control. Of the house dust mite interventions studied to date, acaricides appear to be the most promising type of intervention, although the findings from the two studies which employed these interventions need to be interpreted with care because of their methodological limitations. Use of house dust mite impermeable bedding as an isolated intervention is unlikely to offer clinical benefit. No serious adverse effects were reported from any of the interventions.Authors' conclusionsTrials to date have on the whole been small and of poor methodological quality, making it difficult to offer any definitive recommendations on the role, if any, of house dust mite avoidance measures in the management of house dust mite sensitive perennial allergic rhinitis. The results of these studies suggest that use of acaricides and extensive bedroom based environmental control programmes may be of some benefit in reducing rhinitis symptoms and, if considered appropriate, these should be the interventions of choice. Isolated use of house dust mite impermeable bedding is unlikely to prove effective.
Allergen injection immunotherapy for seasonal allergic rhinitis.
BackgroundAllergic rhinitis is the most common of the allergic diseases. Despite improved understanding of the pathophysiology of allergic rhinitis and advances in its pharmacological treatment, its prevalence has increased worldwide. For patients whose symptoms remain uncontrolled despite medical treatment, allergen injection immunotherapy is advised. An allergen-based treatment may reduce symptoms, the need for medication and modify the natural course of this disease.ObjectivesTo evaluate the efficacy and safety of subcutaneous specific allergen immunotherapy, compared with placebo, for reducing symptoms and medication requirements in seasonal allergic rhinitis patients.Search strategyWe searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 1 2006), MEDLINE (1950 to 2006), EMBASE (1974 to 2006), Pre-MEDLINE, KOREAMED, INDMED, LILACS, PAKMEDINET, Scisearch, mRCT and the National Research Register. The date of the last search was February 2006.Selection criteriaAll studies identified by the searches were assessed to identify randomised controlled trials involving participants with symptoms of seasonal allergic rhinitis and proven allergen sensitivity, treated with subcutaneous allergen specific immunotherapy or corresponding placebo.Data collection and analysisTwo independent authors identified all studies reporting double-blind, placebo controlled randomised trials of specific immunotherapy in patients with seasonal allergic rhinitis due to tree, grass or weed pollens. Two authors independently performed quality assessment of studies. Data from identified studies were abstracted onto a standard extraction sheet and subsequently entered into RevMan 4.2.8. Analysis was performed using the Standardised Mean Difference (SMD) method and a random-effects model; P values < 0.05 were considered statistically significant. The primary outcome measures were symptom scores, medication use, quality of life and adverse events.Main resultsWe retrieved 1111 publications of which 51 satisfied our inclusion criteria. In total there were 2871 participants (1645 active, 1226 placebo), each receiving on average 18 injections. Duration of immunotherapy varied from three days to three years. Symptom score data from 15 trials were suitable for meta-analysis and showed an overall reduction in the immunotherapy group (SMD -0.73 (95% CI -0.97 to -0.50, P < 0.00001)). Medication score data from 13 trials showed an overall reduction in the immunotherapy group (SMD of -0.57 (95% CI -0.82 to -0.33, p<0.00001)). Clinical interpretation of the effect size is difficult. Adrenaline was given in 0.13% (19 of 14085 injections) of those on active treatment and in 0.01% (1 of 8278 injections) of the placebo group for treatment of adverse events. There were no fatalities.Authors' conclusionsThis review has shown that specific allergen injection immunotherapy in suitably selected patients with seasonal allergic rhinitis results in a significant reduction in symptom scores and medication use. Injection immunotherapy has a known and relatively low risk of severe adverse events. We found no long-term consequences from adverse events.
Lineages of language and the diagnosis of asthma.
Asthma, wheeze and cough are words with profoundly differing histories, etymologies and meanings. Yet their medical usage today is clustered around the diagnosis and management of a single disease. Hitherto, asthma has been a clinical diagnosis but wheeze, cough and asthma now are key terms in cross-cultural questionnaire surveys which seek information on asthma prevalence. In this essay, we examine differences in the linguistic properties of terms likely to be relevant to interpreting large-scale variations in asthma prevalence uncovered by questionnaires. We show how etymologically distinct each term is: while asthma and cough each share semantic congruencies across six European languages, albeit for different reasons, there is less congruence across these languages for the term wheeze. The medical meanings of all three terms contrast with meanings revealed by the non-medical usage of all three terms, which are highly figurative. Linguistic considerations indicate that interpretation of international questionnaires that phrase questions in terms of cough, asthma and their derivatives are likely to be more reliable for the purposes of comparing prevalence than those which deploy questions phrased in terms of wheeze.