Showing papers by "Cochrane Collaboration published in 2004"

Is the placebo powerless? Update of a systematic review with 52 new randomized trials comparing placebo with no treatment

Abstract: . Background. It is widely believed that placebo interventions induce powerful effects. We could not confirm this in a systematic review of 114 randomized trials that compared placebo-treated with untreated patients. Aim. To study whether a new sample of trials would reproduce our earlier findings, and to update the review. Methods. Systematic review of trials that were published since our last search (or not previously identified), and of all available trials. Results. Data was available in 42 out of 52 new trials (3212 patients). The results were similar to our previous findings. The updated review summarizes data from 156 trials (11 737 patients). We found no statistically significant pooled effect in 38 trials with binary outcomes, relative risk 0.95 (95% confidence interval 0.89–1.01). The effect on continuous outcomes decreased with increasing sample size, and there was considerable variation in effect also between large trials; the effect estimates should therefore be interpreted cautiously. If this bias is disregarded, the pooled standardized mean difference in 118 trials with continuous outcomes was −0.24 (−0.31 to −0.17). For trials with patient-reported outcomes the effect was −0.30 (−0.38 to −0.21), but only −0.10 (−0.20 to 0.01) for trials with observer-reported outcomes. Of 10 clinical conditions investigated in three trials or more, placebo had a statistically significant pooled effect only on pain or phobia on continuous scales. Conclusion. We found no evidence of a generally large effect of placebo interventions. A possible small effect on patient-reported continuous outcomes, especially pain, could not be clearly distinguished from bias.

Estimating grizzly bear distribution and abundance relative to habitat and human influence

Abstract: Understanding factors that influence and predict grizzly bear (Ursus arctos) distribution and abundance is fundamental to their conservation. In southeast British Columbia, Canada, we applied DNA hair-trap sampling (1) to evaluate relationships of grizzly bear detections with landscape variables of habitat and human activity, and (2) to model the spatial distribution and abundance of grizzly bears. During 1996–1998, we sampled grizzly bear occurrence across 5,496 km2 at sites distributed according to grid cells. We compared 244 combinations of sampling sites and sessions where grizzly bears were detected (determined by nDNA analyses) to 845 site–sessions where they were not. We tested for differences in 30 terrain, vegetation, land cover, and human influence variables at 3 spatial scales. Grizzly bears more often were detected in landscapes of relatively high elevation, steep slope, rugged terrain, and low human access and linear disturbance densities. These landscapes also were comprised of more...

Polyclonal Immunoglobulin for Treatment of Bacterial Sepsis: A Systematic Review

Abstract: Randomized trials of adjunctive treatment of bacterial sepsis with polyclonal immunoglobulin show conflicting results. We performed a systematic review and a meta-analysis of the results of randomized trials that compared reductions in mortality rates in patient groups treated with polyclonal immunoglobulin versus either placebo or no treatment in addition to conventional treatment. High-quality trials had adequate concealment of allocation, were double-blinded and placebo-controlled, and made data available for intention-to-treat analyses. Twenty trials were included. Meta-analysis of all trials showed a relative risk of death with immunoglobulin treatment of 0.77 (95% confidence interval [CI], 0.68-0.88). High-quality trials (involving a total of 763 patients, 255 of whom died) showed a relative risk of 1.02 (95% CI, 0.84-1.24), whereas other trials (involving a total of 948 patients, 292 of whom died) showed a relative risk of 0.61 (95% CI, 0.50-0.73). Because high-quality trials failed to demonstrate a reduction in mortality, polyclonal immunoglobulin should not be used for treatment of sepsis except in randomized clinical trials.

Artificial and bioartificial support systems for liver failure

Abstract: Background Artificial and bioartificial liver support systems may 'bridge' patients with acute or acute-on-chronic liver failure to liver transplantation or recovery. Objectives To evaluate beneficial and harmful effects of artificial and bioartificial support systems for acute and acute-on-chronic liver failure. Search strategy Trials were identified through The Cochrane Hepato-Biliary Group Controlled Trials Register (September 2002), The Cochrane Central Register of Controlled Trials on The Cochrane Library (Issue 3, 2002), MEDLINE (1966 - September 2002), EMBASE (1985 - September 2002), and The Chinese Biomedical Database (September 2002), manual searches of bibliographies and journals, authors of trials, and pharmaceutical companies. Selection criteria Randomised clinical trials on artificial or bioartificial support systems for acute or acute on-chronic liver failure were included irrespective of blinding, publication status, or language. Non-randomised studies were included in explorative analyses. Data collection and analysis Data were extracted independently by three reviewers. Results were presented as relative risks (RR) with 95% confidence intervals (CI). Sources of heterogeneity were explored through sensitivity analyses and meta-regression. The primary outcome was mortality. Main results Twelve trials on artificial or bioartificial support systems versus standard medical therapy (483 patients) and two trials comparing different artificial support systems (105 patients) were included. Most trials had unclear methodological quality. Compared to standard medical therapy, support systems had no significant effect on mortality (RR 0.86; 95% CI 0.65-1.12) or bridging to liver transplantation (RR 0.87; 95% CI 0.73-1.05), but a significant beneficial effect on hepatic encephalopathy (RR 0.67; 95% CI 0.52-0.86). Meta-regression indicated that the effect of support systems depended on the type of liver failure (P = 0.03). In subgroup analyses, artificial support systems appeared to reduce mortality by 33% in acute-on-chronic liver failure (RR 0.67; 95% CI 0.51-0.90), but not in acute liver failure (RR 0.95; 95% CI 0.71-1.29). Two trials comparing artificial support systems showed significant mortality reductions with intermittent versus continuous haemofiltration (RR 0.58; 95% CI 0.36-0.94) and no significant difference between five versus ten hours of charcoal haemoperfusion (RR 1.03; 95% CI 0.65-1.62). The incidence of adverse events was inconsistently reported. Reviewer's conclusions This Review indicates that artificial support systems may reduce mortality in acute-on-chronic liver failure. Artificial and bioartificial support systems did not appear to affect mortality in acute liver failure. However, considering the strength of the evidence additional randomised clinical trials are needed before any support system can be recommended for routine use.

Presentation on websites of possible benefits and harms from screening for breast cancer: cross sectional study

Abstract: Objective To investigate whether information on mammographic screening presented on websites by interest groups is balanced, is independent of source of funding, and reflects recent findings. Design Cross sectional study using a checklist with 17 information items. Setting 27 websites in Scandinavian and English speaking countries. Results The 13 sites from advocacy groups and the 11 from governmental institutions all recommended mammographic screening, whereas the three from consumer organisations questioned screening (P = 0.0007). All the advocacy groups accepted industry funding, apparently without restrictions. In contrast the three consumer organisations acknowledged the risk of bias related to industry funding, and two of them did not accept such funding at all. Advocacy groups and governmental organisations favoured information items that shed positive light on screening. The major harms of screening, overdiagnosis and overtreatment, were mentioned by only four of these groups, but by all three sites from consumer organisations (P = 0.02). In addition, the chosen information was often misleading or erroneous. The selection of information items for websites did not reflect recent findings, apart from the consumer sites, which were much more balanced and comprehensive than other sites (median of 9 information items v3 items, P = 0.03). Conclusions The information material provided by professional advocacy groups and governmental organisations is information poor and severely biased in favour of screening. Few websites live up to accepted standards for informed consent such as those stated in the General Medical Council9s guidelines.

Interaction of St John's wort with conventional drugs: systematic review of clinical trials

Abstract: Objective To determine the methodological quality of clinical trials that examined possible interactions of St John9s wort with conventional drugs, and to examine the results of these trials. Design Systematic review. Data sources Electronic databases from inception to April 2004, reference lists from published reports, and experts in the field. Study selection Eligible studies were prospective clinical trials evaluating the pharmacokinetic effect of St John9s wort on the metabolism of conventional drugs. Data extraction Two reviewers selected studies for inclusion and independently extracted data. Data synthesis 22 pharmacokinetic trials studied an average of 12 (SD 5) participants; 17 trials studied healthy volunteers and five studied patients. Most (17) studies used a “before and after” design; four studies used control groups other than the active group. Three studies randomised the sequence of administration or the participants to study arms or periods; three studies blinded participants or investigators. In 15 trials, investigators independently assayed the herb. Of 19 trials with available plasma data, three found no important interaction (change in area under the curve Conclusion Clinicians and patients should beware of possible decreases in the systemic bioavailability of conventional drugs when taken concomitantly with St John9s wort.

Adverse events after immunisation with aluminium-containing DTP vaccines: systematic review of the evidence

Abstract: Summary We have reviewed evidence of adverse events after exposure to aluminium-containing vaccines against diphtheria, tetanus, and pertussis (DTP), alone or in combination, compared with identical vaccines, either without aluminium or containing aluminium in different concentrations. The study is a systematic review with meta-analysis. We searched the Cochrane Vaccines Field Register, the Cochrane Library, Medline, Embase, Biological Abstracts, Science Citation Index, and the Vaccine Adverse Event Reporting System website for relevant studies. Reference lists of retrieved articles were scanned for further studies. We included randomised and semi-randomised trials and comparative cohort studies if the report gave sufficient information for us to extract aluminium concentration, vaccine composition, and safety outcomes. Two reviewers extracted data in a standard way from all included studies and assessed the methodological quality of the studies. We identified 35 reports of studies and included three randomised trials, four semi-randomised trials, and one cohort study. We did a meta-analysis of data from five studies around two main comparisons (vaccines containing aluminium hydroxide vs no adjuvant in children aged up to 18 months and vaccines containing different types of aluminium vs no adjuvants in children aged 10–16 years). In young children, vaccines with aluminium hydroxide caused significantly more erythema and induration than plain vaccines (odds ratio 1·87 [95% Cl 1·57–2·24]) and significantly fewer reactions of all types (0·21 [0·15–0·28]). The frequencies of local reactions of all types, collapse or convulsions, and persistent crying or screaming did not differ between the two cohorts of the trials. In older children, there was no association between exposure to aluminium-containing vaccines and onset of (local) induration, swelling, or a raised temperature, but there was an association with local pain lasting up to 14 days (2·05 [1·25–3·38]). We found no evidence that aluminium salts in vaccines cause any serious or long-lasting adverse events. Despite a lack of good-quality evidence we do not recommend that any further research on this topic is undertaken.

Inter-observer reproducibility of measurements of range of motion in patients with shoulder pain using a digital inclinometer

Abstract: Reproducible measurements of the range of motion are an important prerequisite for the interpretation of study results. The digital inclinometer is considered to be a useful instrument because it is inexpensive and easy to use. No previous study assessed inter-observer reproducibility of range of motion measurements with a digital inclinometer by physical therapists in a large sample of patients. Two physical therapists independently measured the passive range of motion of the glenohumeral abduction and the external rotation in 155 patients with shoulder pain. Agreement was quantified by calculation of the mean differences between the observers and the standard deviation (SD) of this difference and the limits of agreement, defined as the mean difference ± 1.96*SD of this difference. Reliability was quantified by means of the intraclass correlation coefficient (ICC). The limits of agreement were 0.8 ± 19.6 for glenohumeral abduction and -4.6 ± 18.8 for external rotation (affected side) and quite similar for the contralateral side and the differences between sides. The percentage agreement within 10° for these measurements were 72% and 70% respectively. The ICC ranged from 0.28 to 0.90 (0.83 and 0.90 for the affected side). The inter-observer agreement was found to be poor. If individual patients are assessed by two different observers, differences in range of motion of less than 20–25 degrees can not be distuinguished from measurement error. In contrast, acceptable reliability was found for the inclinometric measurements of the affected side and the differences between the sides, indicating that the inclimeter can be used in studies in which groups are compared.

Anticholinergic agents for chronic asthma in adults

Abstract: BACKGROUND Anticholinergic agents such as ipratropium bromide are sometimes used in the treatment of chronic asthma. They effect bronchodilation and have also been used in combination with beta2-agonists in the management of chronic asthma. OBJECTIVES To examine the effectiveness of anticholinergic agents versus placebo and in comparison with beta2-agonists or as adjunctive therapy to beta2-agonists. SEARCH STRATEGY The Cochrane Airways Group asthma and wheeze database was searched with a pre-defined search strategy. Searches were current as of August 2003. Reference lists of articles were also examined. SELECTION CRITERIA Randomised trials or quasi-randomised trials were considered for inclusion. Studies assessing an anticholinergic agent versus placebo or in combination/comparison with beta2-agonists were included. In practice, all beta2-agonists were short acting. Short-term (less than 24 hours duration) and longer-term studies were separated; the latter are reported in this review and the former in the review, "Anticholinergic agents for chronic asthma in adults short term". DATA COLLECTION AND ANALYSIS Two reviewers independently assessed abstracts for retrieval of full text articles. Papers were then assessed for suitability for inclusion in the review. Data from included studies were extracted by two reviewers and entered into the software package (RevMan 4.2). We contacted authors for missing data and some responded. Adverse effect data were analysed if reported in the included studies. MAIN RESULTS The studies analysed were in two groups: those comparing anticholinergics with placebo and those comparing the combination of anticholinergics with short acting beta2-agonists versus short acting beta2-agonists alone. The former group had 13 studies involving 205 participants included in this review, and the latter 9 studies involving 440 patients. Generally methodological quality was poorly reported, and there were some reservations with respect to the quality of the studies. Despite the limited number of studies that could be combined, anticholinergic agents in comparison with placebo resulted in more favourable symptom scores particularly in respect of daytime dyspnoea (WMD -0.09 (95%CI -0.14, -0.04, 3 studies, 59 patients). Daily peak flow measurements also showed a statistically significant improvement for the anticholinergic (e.g. morning PEF: WMD =14.38 litres/min (95%CI 7.69, 21.08; 3 studies, 59 patients). However the clinical significance is small and in terms of peak flow measurements equates to approximately a 7% increase over placebo. The more clinically relevant comparison of a combination of anticholinergic plus short acting beta2-agonist versus short acting beta2-agonist alone gave no evidence in respect of symptom scores or peak flow rates of any significant differences between the two regimes. Again there are reservations with respect to the quality of the information from which these conclusions are drawn. REVIEWERS' CONCLUSIONS Overall this review provides no justification for routinely introducing anticholinergics as part of add-on treatment for patients whose asthma is not well controlled on standard therapies. This does not exclude the possibility that there may be a sub-group of patients who derive some benefit and a trial of treatment in individual patients may still be justified. The role of long term anticholinergics such as tiotropium bromide has yet to be established in patients with asthma and any future trials might draw on the messages derived from this review.

Erythropoietin for patients with malignant disease

Abstract: Background Anaemia associated with cancer and cancer therapy is an important clinical factor in the treatment of malignant diseases. Therapeutic alternatives are recombinant human erythropoietin (EPO) and red blood cell transfusions. Objectives The aim of this systematic review was to assess the effect of erythropoietin to either prevent or treat anaemia in cancer patients. Search strategy We searched the Central Register of Controlled Trials, MEDLINE (01/1985 to 12/2001), EMBASE (01/1985 to 12/2001), other databases and reference lists of articles. We also contacted experts in the field and pharmaceutical companies. Selection criteria Randomised controlled trials comparing the use of recombinant human erythropoietin (plus transfusion if needed) with red blood cell transfusions alone for the treatment or prevention of anaemia in cancer patients. Data collection and analysis Two reviewers independently assessed trial quality and extracted data. All authors from included studies were contacted for additional information. Main results Twenty seven trials with 3,287 adults were included. Use of erythropoietin significantly reduced the relative risk of red blood cell transfusions (RR 0.67; 95% CI 0.62 to 0.73, 25 trials, n = 3,069). On average participants in the erythropoietin group received one unit of blood less than the control group (WMD -1.00; 95% CI-1.31 to -0.70, 13 trials, n = 2,056). For participants with baseline haemoglobin below 10 g/dL haematological response was observed more often in participants receiving EPO (RR 3.60; 95% CI 3.07 to 4.23, 14 trials, n = 2,347). There was inconclusive evidence whether EPO improves tumour response (fixed effect RR 1.36; 95% CI 1.07 to 1.72, seven trials, n = 1,150; random effects: RR 1.21; 95% CI 0.92 to 1.59) and overall survival (adjusted data: HR 0.81; 95% CI 0.67 to 0.99; unadjusted data: HR 0.84; 95% CI 0.69 to 1.02, 19 trials, n = 2,865). There were no statistically significant adverse effects. Evidence was inconclusive with respect to quality of life and fatigue. Reviewers' conclusions There is consistent evidence that the administration of erythropoietin reduces the risk for blood transfusions and the number of units transfused in cancer patients. For patients with baseline haemoglobin below 10 g/dL there is strong evidence that erythropoietin improves haematological response. There is inconclusive evidence whether erythropoietin improves tumour response and overall survival. Research on side effects is inconclusive.

Amantadine and rimantadine for preventing and treating influenza A in adults.

Abstract: BACKGROUND Amantadine hydrochloride and rimantadine hydrochloride have antiviral properties, but these drugs are not widely used due to a lack of knowledge of their potential value and concerns about possible adverse effects. OBJECTIVES The objective of this review was to assess the effectiveness and safety ("effects") of amantadine and rimantadine in healthy adults. SEARCH STRATEGY We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 4, 2003), MEDLINE (January 1966 to November week 2, 2003), EMBASE (January 1990 to September 2003) and the reference lists of articles. We also contacted manufacturers, researchers and authors. SELECTION CRITERIA Randomised and quasi-randomised studies comparing amantadine and/or rimantadine with placebo, control antivirals or no intervention, or comparing doses or schedules of amantadine and/or rimantadine in healthy adults. DATA COLLECTION AND ANALYSIS For prevention trials the numbers of participants with clinical influenza (influenza-like-illness or ILI), i.e. confirmed influenza A, and adverse effects were analysed. Analysis for treatment trials included the mean duration of fever and length of hospital stay, and the number of adverse effects. MAIN RESULTS Amantadine prevented 25% of ILI cases (95% confidence interval (CI) 13% to 36%), and 61% of influenza A cases (95% CI 35% to 76%). Amantadine reduced duration of fever by one day (95% CI 0.7 to 1.3). Rimantadine demonstrated comparable effectiveness, but there were fewer trials and the results for prevention were not statistically significant. Both amantadine and rimantadine induced significant gastrointestinal adverse effects. Adverse effects of the central nervous system and study withdrawals were significantly more common with amantadine than rimantadine. REVIEWERS' CONCLUSIONS Amantadine and rimantadine have comparable effectiveness in the prevention and treatment of influenza A in healthy adults, although rimantadine causes fewer adverse effects than amantadine.

Applying Emotional Intelligence: Exploring the Promoting Alternative Thinking Strategies curriculum

Abstract: This paper describes a collaborative action research project in one primary school that arose from a mutual interest in applying the concept of “Emotional Intelligence”. It involves an exploratory qualitative study of the Promoting Alternative Thinking Strategies (PATHS) curriculum. This is an approach aimed at promoting emotional competence in children and young people. The PATHS curriculum was chosen because of its clear conceptualisation of emotion, its emphasis upon cognitive and developmental aspects and its research history. One class of 9 and 10 year olds took part in the project. Target children were selected from within this group for closer monitoring. The outcomes suggest that PATHS was rated very positively by class teachers, pupils and other staff involved in the project. Positive emotional, social and behavioural changes at a class and individual level were attributed to the effects of PATHS. Finally, the importance of developing a positive school ethos was highlighted as promoting these eff...

Does the architecture of hospital facilities influence nosocomial infection rates? A systematic review

Abstract: Objective To review the evidence regarding the effects of interventions to improve hospital design and construction on the occurrence of nosocomial infections. Methods Systematic review of experimental and non-experimental, architectural intervention studies in intensive care units (ICUs), surgical departments, isolation units, and hospitals in general. The studies dated from 1975, and were in English, French, German, Italian, and Spanish. Regardless of format, the studies were identified through seven medical databases, reference lists, and expert consultation. Results One hundred seventy-eight scientific articles were identified; however, none of these described a meta-analysis, systematic review, or randomized, controlled trial. Most of the articles were categorized at the lowest level of evidence (expert judgment or consensus statements). Only 17 described completed concurrent or historical cohort studies matching the inclusion criteria (ICUs, 9; surgical departments, 4; isolation units, 2; hospitals in general, 2). The interventions generally included a move to other premises or renovation. However, in many studies, the staff-to-patient ratio was also improved. Some studies showed lower infection rates after intervention, but this finding cannot be generalized because of confounding and frequently small study populations. Conclusions The lack of stringent evidence linking hospital design and construction with the prevention of nosocomial infection is partly attributable to the multifactorial nature of these infections, and some improvement will be seen if basic conditions such as the availability of sufficient space, isolation capacity, and facilities for handwashing are met. However, to our knowledge, other factors, especially the improper hand hygiene of medical staff, have greater impact.

Doing new research? Don't forget the old.

Abstract: Nobody should do a new research study, says Clarke, without first systematically reviewing the literature. And journal editors should insist that all research papers are accompanied by an up-to-date systematic review.

Penicillins for the prophylaxis of bacterial endocarditis in dentistry

Abstract: BACKGROUND Many dental procedures cause bacteraemia and it is believed that this may lead to bacterial endocarditis (BE) in a few people. Guidelines in many countries recommend that prior to invasive dental procedures antibiotics are administered to people at high risk of endocarditis. However, it is unclear whether the potential risks of this prophylaxis outweigh the potential benefits. OBJECTIVES To determine whether prophylactic penicillin administration compared to no such administration or placebo before invasive dental procedures in people at increased risk of BE influences mortality, serious illness or endocarditis incidence. SEARCH STRATEGY The search strategy was developed on MEDLINE and adapted for use on the Cochrane Oral Health, Heart and Infectious Diseases Groups' Trials Registers (to October 2003), as well as the following databases: Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 2, 2002), OLDMEDLINE (1966 to June 2002); EMBASE (1980 to June 2002); SIGLE (to June 2002); and the Meta-register of current controlled trials. SELECTION CRITERIA Due to the low incidence of BE it was anticipated that few if any trials would be located. For this reason, cohort and case controlled studies were included where suitably matched control or comparison groups had been studied. The intervention was the administration of penicillin compared to no such administration before a dental procedure in people with an increased risk of BE. Cohort studies would need to follow those at increased risk and assess outcomes following any invasive dental procedures, grouping by whether prophylaxis was received. Included case control studies would need to match people who had developed endocarditis (and who were known to be at increased risk before undergoing an invasive dental procedure preceding the onset of endocarditis) with those at similar risk but who had not developed endocarditis. Outcomes of interest were: mortality or serious adverse event requiring hospital admission; development of endocarditis following any dental procedure in a defined time period; development of endocarditis due to other non-dental causes; any recorded adverse events to the antibiotics; and cost implications of the antibiotic provision for the care of those patients who develop endocarditis. DATA COLLECTION AND ANALYSIS Two reviewers independently selected studies for inclusion, then assessed quality and extracted data from the included study. MAIN RESULTS No RCTs, CCTs or cohort studies were included. One case-control study met the inclusion criteria. It collected all the cases of endocarditis in the Netherlands over 2 years, finding a total of 24 people who developed endocarditis within 180 days of an invasive dental procedure, definitely requiring prophylaxis according to current guidelines and who were at increased risk of endocarditis due to a pre-existing cardiac problem. This study included participants who died because of the endocarditis (using proxys). Controls attended local cardiology outpatient clinics for similar cardiac problems, had undergone an invasive dental procedure within the past 180 days and were matched by age with the cases. No significant effect of penicillin prophylaxis on the incidence of endocarditis could be seen. No data were found on other outcomes. REVIEWERS' CONCLUSIONS There is no evidence about whether penicillin prophylaxis is effective or ineffective against bacterial endocarditis in people at risk who are about to undergo an invasive dental procedure. There is a lack of evidence to support published guidelines in this area. It is not clear whether the potential harms and costs of penicillin administration outweigh any beneficial effect. Ethically practitioners need to discuss the potential benefits and harms of antibiotic prophylaxis with their patients before a decision is made about administration.

Antibody response to Pseudomonas aeruginosa in cystic fibrosis patients: a marker of therapeutic success?--A 30-year cohort study of survival in Danish CF patients after onset of chronic P. aeruginosa lung infection.

Abstract: We studied the effects of increasingly intensive treatment regimens on anti-pseudomonal antibody response and survival in five successive cohorts of a total of 157 Danish cystic fibrosis patients after they had acquired chronic P. aeruginosa lung infection. The time periods were 1971–1975 (N = 21), 1976–1980 (N = 64), 1981–1986 (N = 27), 1987–1993 (N = 26), and 1994–2000 (N = 19). During this 30-year period, we introduced elective 2-week courses of chemotherapy every third month in all chronically infected patients, early aggressive treatment with inhalation of colistin and oral ciprofloxacin for 3 months whenever P. aeruginosa was cultured in sputum from noncolonized patients, and inhalation of recombinant human dornase alfa. There was a significant correlation between the calendar year when chronic P. aeruginosa infection was acquired and the subsequent increase in the level of precipitins (P < 0.00001). The median number of precipitins increased by 5 per year in the oldest calendar year cohort, and 1 per year in the youngest. The median age of onset of chronic P. aeruginosa increased from 9.3 years from 1981–1986 to 13.8 years from 1987–2000. Survival after acquisition of chronic P. aeruginosa lung infection improved with time (P = 0.008). Our study shows that CF patients who are treated intensively have lower antibody responses and longer survival after acquisition of chronic P. aeruginosa lung infection. Pediatr Pulmonol. 2004; 37:427–432. © 2004 Wiely-Liss, Inc.

Techniques to preserve data constraints and referential integrity in asynchronous transactional replication of relational tables

Abstract: An improved method and system for preserving data constraints during parallel apply in asynchronous transaction replication in a database system have been disclosed. The method and system preserves secondary unique constraints and referential integrity constraints, while also allowing a high degree of parallelism in the application of asynchronous replication transactions. The method and system also detects and resolves ordering problems introduced by referential integrity cascade deletes, and allows the parallel initial loading of parent and child tables of a referential integrity constraint.

Occlusal adjustment for treating and preventing temporomandibular joint disorders

Abstract: The Cochrane Collaboration is an international organization that aims to help people make well-informed decisions about healthcare by preparing, maintaining and promoting the accessibility of systematic reviews on the effects of healthcare interventions. The Cochrane Oral Health Group aims to produce systematic reviews which primarily include all randomized control trials (RCTs) of oral health, including prevention, treatment and rehabilitation of oral, dental and craniofacial diseases and disorders. The abstracts of these reviews can be accessd electronically at http:www.cochrane-oral.man.ac.uk. Full copies of the review papers can also be purchased via this website. TheAustralian Dental Journal publishes selected abstracts in each issue for our readers' interest. A detailed description of the activities of the Cochrane Oral Health Group, written by the Review Group Co-ordinator, Dr Emma Tavender, was published in the June 2004 issue of the Journal (Aust Dent J 2004;49:58–59). Also, for explanations of abbreviations and terminology please see Appendix 1 on page 59 of the aforementioned article. EDITOR

The challenges of systematically reviewing public health interventions.

Abstract: Evidence-based public health concerns the development and implementation of effective programmes and policies. For policy makers and practitioners to implement effective programmes they must have considered the information that is available on which interventions have been shown to work, or not to work (or caused harm). One form of high quality evidence-based information available to decision makers is a systematic review of research of effectiveness. A systematic review is defined as ‘a review of a clearly formulated question that uses systematic and explicit methods to identify, select and critically appraise relevant research, and to collect and analyse data from the studies included in the review’. Many of the tools of research synthesis were developed by American social scientists in the 1960s. However, today’s focus on evidence in health has been largely driven by the evidencebased medicine movement. Some authors have argued that there are concerns that in cost-conscious environments only those interventions for which there is sufficient evidence to complete a review would be supported. In public health the infrastructure that supports and enables the conduct of a review lags behind that of evidence-based medicine and extends beyond the employment of randomized controlled trials. This increased complexity has resulted in an unfortunate focus on the appropriateness (or not) of randomized controlled trials as the priority study design rather than what constitutes evidence in public health and how this should be evaluated. However, after diverging views, the focus has now moved towards ensuring that reviews in public health meet the needs of public health practitioners. Conducting systematic reviews of complex public health interventions is methodologically challenging. The following section outlines many of the issues faced when reviewing evidence of public health intervention effectiveness.

Paracetamol versus nonsteroidal anti-inflammatory drugs for rheumatoid arthritis.

Abstract: Background Nonsteroidal anti-inflammatory drugs (NSAIDs) are usually preferred for simple analgesics such as paracetamol for rheumatoid arthritis. It is not clear, however, whether the trade-offs between benefits and harms of NSAIDs are preferable to those of paracetamol (paracetamol is also called acetaminophen). Objectives To compare the benefits and harms of paracetamol with NSAIDs in patients with rheumatoid arthritis. Search methods PubMed and EMBASE databases were searched up until August 2007. Reference lists of identified articles were also searched. Selection criteria Randomised double-blind studies comparing paracetamol with an NSAID. Data collection and analysis Decisions on inclusion of trials and data extraction were performed by the two authors independently. Main results Four cross-over studies, published between 1968 and 1982, involving 121 patients, and four different NSAIDs were included. The generation of the allocation sequence and the use of methods to conceal the allocation were not described in any of the studies. The studies were double-blind but it was not clear whether the blinding was effective. Methods for collecting adverse effects were not described. The NSAIDs were preferred more often than paracetamol by the patients or the investigator. In the largest trial, 20 out of 54 patients (37%) preferred ibuprofen and 7 out of 54 (13%) paracetamol. Investigators preference (as established by joint tenderness, grip strength and joint circumference) was 17 out of 35 for diclofenac versus 5 out of 35 for paracetamol in another trial. However, because of the weaknesses in the trials, no firm conclusion can be drawn. Authors' conclusions When considering the trade off between the benefits and harms of non-steroidal anti-inflammatory drugs and paracetamol/acetaminophen, it is not known whether one is better than the other for rheumatoid arthritis. But people with rheumatoid arthritis and the researchers in the study did prefer non-steroidal anti-inflammatory drugs more than acetaminophen/paracetamol. There is a need for a large trial, with appropriate randomisation, double-blinding, test of the success of the blinding, and with explicit methods to measure and analyse pain and adverse effects.

On the benefits and harms of screening for breast cancer.

Abstract: claim that our critique of the randomized screening trials has little merit; that there is no reason to believe that the Canadian study was of better quality than the New York Health Insurance Plan (HIP) study or the Two-County study; and that the prior consensus on mammography was correct. However, their review suffers from erroneous assumptions and biased statistical analyses, and their quotations are often selective and misleading. In my discussion of the issues, I will follow when possible the sequence of arguments used by FPR. FPR claim in their abstract that early detection leads to less invasive therapy. This could have been true, if the only effect of screening had been to detect the same tumours earlier that are detected later if women are not screened. FPR naively believe that screening does just that, i.e. does not lead to overdiagnosis. They note, for example, that the incidence of breast cancers in the New York HIP study is the same in the control group as in the screening group 5–7 years after screening started (their table 2), as they expected. I will explain under the HIP study below why this argument is faulty. The level of overdiagnosis can be studied reliably in the trials from Canada and Malmö which did not differentially exclude women with prior breast cancer after randomization and did not introduce early, systematic screening of the whole control group. 2–4 There was an overdiagnosis of 30% 5,6 which corresponds closely to the 31% excess surgery we have previously described 2,3 (Table 1). A similar result was seen for the trials that screened the whole control group when only cancers before this screen were included 7–9 (Table 2). The excess surgery rate was 20% for mastectomies. 2,3 We have discussed in detail why it is likely that even today, there would be about 20% more mastectomies when women are screened than if they are not screened. 3 In Southeast Netherlands, for example, when screening was introduced from 1990 to 1998, the number of women who underwent breast-conserving surgery increased by 71%, and the number of women who underwent mastectomy increased by 84%. 10 If the study had included carcinoma in situ there would have been even more mastectomies. 3,11 A study from Italy claimed that screening had not led to an increase in mastectomies, 12 but this study had no control group and the premises for the study …

The use of a spatial information system in the management of HIV/AIDS in South Africa

Abstract: South Africa is experiencing an HIV/AIDS pandemic of shattering dimensions The availability and provision of antiretroviral (ARV) drugs could bring relief to the situation, but the treatment is unfortunately complex with each patient being assigned a different antiretroviral therapy varying in diet-medication regiment The context of South Africa, its variety of urban and rural settings adds to the challenge of administering and monitoring the HIV+ person throughout the treatment, which will last for the rest of their lives The lack of physical infrastructure, reliable statistics and adequate resources hinder the efficient management of HIV/AIDS The collection of reliable data will be a first step to assess the status of HIV/AIDS in communities A number of hospitals have started this process using the conventional approach to collect information about their patients using a paper-based system Since time is of essence in the fight against the pandemic, data exchange between various hospitals, municipalities and decision-making bodies is becoming more and more important The logical response to such a need is a computerised system, which will collect and administer HIV/AIDS related information within the local context and allow a monitored access to the data from a number of stakeholders The purpose of this study was to design and develop an HIV/AIDS database, which is embedded in a Spatial Information Management System The pilot study area is the Gugulethu township in Cape Town where more than 27% of the 325 000 residents are HIV+ It is shown that the implementation of the HIV/AIDS database and the Spatial Information Management System can play a critical role in determining where and when to intervene, improving the quality of care for HIV+ patients, increasing accessibility of service and delivering a cost-effective mode of information

Transurethral microwave thermotherapy vs transurethral resection for treating benign prostatic hyperplasia: A systematic review

Abstract: Technology has been used in the management of BPH, sometimes without much evidence to support its use. The first manuscript is a systematic review of the literature comparing transurethral microwave therapy to TURP. This shows that although microwave therapy is safe and effective in the short term, it is not as effective as TURP. Authors from London report on their long-term (up to 12-years of follow-up) results when using the Urolume wallstent for urethral stricture. They describe the results in detail, and conclude that the stent should only be used in patients who are unfit for or who refuse urethroplasty. OBJECTIVE To conduct a systematic review of randomized controlled trials evaluating the efficacy and safety of transurethral microwave thermotherapy (TUMT) compared with transurethral resection of the prostate (TURP) in treating men with symptomatic benign prostatic hyperplasia (BPH). METHODS We searched Medline, the Cochrane Library and reference lists of retrieved studies to identify randomized trials of ≥ 6 months duration with ≥ 10 patients in each treatment arm. Data were extracted on study design, patient and treatment characteristics, urinary symptoms, urinary flow, adverse events and repeat treatment for BPH. RESULTS Six studies were evaluated, involving 540 patients. The mean age (67.8 years), baseline symptom score (19.5), and peak urinary flow (PUF, 8.6 mL/s) did not differ by treatment group. The pooled mean urinary symptom score decreased by 65% with TUMT and 77% with TURP. The weighted mean (95% confidence interval) difference for the symptom score at the follow-up was −1.83 (−3.09 to −0.58) points, favouring TURP. The pooled mean PUF increased by 70% with TUMT and 119% with TURP. The weighted mean difference for the PUF at the follow-up was 5.37 (4.22–6.51) mL/s, favouring TURP. Retrograde ejaculation (57.6% vs 22.2%), transfusions (5.7% vs 0%) and re-treatment for strictures (relative hazard 9.76) were all significantly more common after TURP, but re-treatment for BPH was significantly more common after TUMT (relative hazard 10.0). CONCLUSIONS TUMT techniques are effective and safe short-term alternatives to TURP for treating BPH. However, TURP provided greater symptom and urinary flow improvements and fewer subsequent BPH treatments than TUMT.

The merits of blastocyst versus cleavage stage embryo transfer: a Cochrane review

Abstract: The merits of blastocyst versus cleavage stage embryotransfer: a Cochrane reviewD.A.Blake, M.Proctor and N.P.JohnsonHum. Reprod., 19, 795–807, 2004The authors wish to point out the following about their paperpublished in Human Reproduction 19/4:We have been contacted by a trial author concerning theabove review. The randomised controlled trial (RCT) pub-lished by Frattarelli et al 2003 entitled “Blastocyst transferdecreases multiple pregnancy rates in in-vitro fertilizationcycles: a randomized controlled trial” (2), has been incor-rectly listed in the excluded trials category Table 1. ThisRCT is indeed a high quality trial reporting valuable livebirth rate data per couple and fits the inclusion criteria formeta-analysis. The trial by Frattarelli et al (2) will beincluded in an update of the Cochrane library version that iscurrently under way and due to be published by the end of2004 (3).Results of the updated meta-analysis including thisadditional trial (2) are as follows:Day 2/3 versus Day 5/6:. Live birth rate per couple: 36.6% vs 44.4% (Peto OR0.72, 95% CI 0.44- 1.17). Pregnancy rate per couple: 39.8% vs 43.2% (Peto OR0.88, 95% CI 0.69- 1.12). Pregnancy rate per couple where fewer blastocysts thancleavage stage embryos were transferred: 39.3% vs 42.0%(Peto OR 0.93 95% CI 0.45- 1.94). Pregnancy rate per couple (good prognosis patients):46.0% vs 47.4% (Peto OR 0.94, 95% CI 0.71-1.24). Multiple pregnancy rate per couple: 14.4% vs 17.1%(Peto OR 0.82, 95% CI 0.57- 1.19). Multiple pregnancy rate per couple where fewer blasto-cysts than cleavage stage embryos were transferred: 15% vs18.8% (Peto OR 0.77, 95% CI 0.49 -1.22). There are no major differences between published dataand this re-analysed data.Inclusion of the data from Frattarelli et al (2) in our meta-analysis reinforces the conclusions stated in our paper: thatthe current evidence does not support a widespread change ofpractice from cleavage stage to blastocyst transfer to improvepregnancy rates (1,3). Although not confirmed by our meta-analysis, this study does highlight, however, the importantpossibility of reducing multiple births, yet maintaining acomparable pregnancy rate, by a policy of transferring fewerblastocysts than cleavage stage embryos (2), depending uponthe success of blastocyst culture at any given clinic. We wishto thank Dr Frattarelli and his group for their prompt corres-pondence and understanding regarding this omission.References

Iodine supplementation for preventing iodine deficiency disorders in children

Abstract: Iodine deficiency is the main cause of potentially preventable mental retardation in childhood, as well as causing goitre and hypothyroidism in people of all ages. It is still prevalent in large parts of the world. The objective of this review is to assess the effects of iodine supplementation overall, and of different forms and dosages of iodine supplementation separately, in the prevention of iodine deficiency disorders in children

Antidepressants and adverse effects in young patients: uncovering the evidence.

Abstract: Family physicians are repeatedly told that depression is underrecognized in patients of all ages and that lack of treatment can lead to serious harm. Selective serotonin reuptake inhibitors (SSRIs) and other, newer, antidepressants have been regarded as the treatment of choice in primary care, and

Rotavirus vaccine for preventing diarrhoea

Abstract: Background Rotaviruses cause viral gastroenteritis and result in more deaths from diarrhoea in children under 5 years of age than any other single agent, particularly in low- and middle-income countries. Objectives To assess rotavirus vaccines in relation to preventing rotavirus diarrhoea, death, and adverse events. Search strategy We searched the Cochrane Infectious Diseases Group's trial register (October 2003), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 3, 2003), MEDLINE (1966 to October 2003), EMBASE (January 1980 to October 2003), LILACS (1982 to October 2003), Biological Abstracts (January 1982 to October 2003), reference lists of articles, and contacted researchers and rotavirus vaccine manufacturers. Selection criteria Randomized controlled trials comparing rotavirus vaccines to placebo, no intervention, or other rotavirus vaccines in children and adults. Data collection and analysis Two reviewers independently extracted data and assessed trial methodological quality, and contacted trial authors for additional information. Main results Sixty-four trials provided information on efficacy and safety of three main types of rotavirus vaccine (bovine, human, and rhesus) for 21,070 children. Different levels of efficacy were demonstrated with different vaccines varying from 22 to 89% to prevent one episode of rotavirus diarrhoea, 11 to 44% to prevent one episode of all-cause diarrhoea, and 43 to 90% to prevent one episode of severe rotavirus diarrhoea. Rhesus vaccine demonstrated a similar efficacy against one episode of rotavirus diarrhoea (37 and 44% respectively), and one episode of all-cause diarrhoea (around 15%) for trials performed in high and middle-income countries. Results on mortality and safety of the vaccines were scarce and incomplete. We noticed important heterogeneity among the pooled studies and were unable to discard a biased estimation of effect. Reviewer's conclusions Current evidence shows that rhesus rotavirus vaccines (particularly RRV-TV) and the human rotavirus vaccine 89-12 are efficacious in preventing diarrhoea caused by rotavirus and all-cause diarrhoea. Evidence about safety, and about mortality or prevention of severe outcomes, is scarce and inconclusive. Bovine rotavirus vaccines were also efficacious, but safety data are not available. Trials of new rotavirus vaccines will hopefully improve the evidence base. Randomized controlled trials should be performed simultaneously in high-, middle-, and low-income countries.