A global reference for caesarean section rates (C-Model): a multicountry cross-sectional study.

OBJECTIVE: To generate a global reference for caesarean section (CS) rates at health facilities. DESIGN: Cross-sectional study. SETTING: Health facilities from 43 countries. POPULATION/SAMPLE: Thirty eight thousand three hundred and twenty-four women giving birth from 22 countries for model building and 10,045,875 women giving birth from 43 countries for model testing. METHODS: We hypothesised that mathematical models could determine the relationship between clinical-obstetric characteristics and CS. These models generated probabilities of CS that could be compared with the observed CS rates. We devised a three-step approach to generate the global benchmark of CS rates at health facilities: creation of a multi-country reference population, building mathematical models, and testing these models. MAIN OUTCOME MEASURES: Area under the ROC curves, diagnostic odds ratio, expected CS rate, observed CS rate. RESULTS: According to the different versions of the model, areas under the ROC curves suggested a good discriminatory capacity of C-Model, with summary estimates ranging from 0.832 to 0.844. The C-Model was able to generate expected CS rates adjusted for the case-mix of the obstetric population. We have also prepared an e-calculator to facilitate use of C-Model (www.who.int/reproductivehealth/publications/maternal_perinatal_health/c-model/en/). CONCLUSIONS: This article describes the development of a global reference for CS rates. Based on maternal characteristics, this tool was able to generate an individualised expected CS rate for health facilities or groups of health facilities. With C-Model, obstetric teams, health system managers, health facilities, health insurance companies, and governments can produce a customised reference CS rate for assessing use (and overuse) of CS. TWEETABLE ABSTRACT: The C-Model provides a customized benchmark for caesarean section rates in health facilities and systems.

Indirect causes of severe adverse maternal outcomes: a secondary analysis of the WHO Multicountry Survey on Maternal and Newborn Health.

OBJECTIVE: To assess the proportion of severe maternal outcomes resulting from indirect causes, and to determine pregnancy outcomes of women with indirect causes. DESIGN: Secondary analysis of the WHO Multicountry Survey on Maternal and Newborn Health. SETTING: A total of 359 health facilities in 29 countries in Africa, Asia, Latin America, and the Middle East. SAMPLE: A total of 314 623 pregnant women admitted to the participating facilities. METHODS: We identified the percentage of women with severe maternal outcomes arising from indirect causes. We evaluated the risk of severe maternal and perinatal outcomes in women with, versus without, underlying indirect causes, using adjusted odds ratios and 95% confidence intervals, by a multilevel, multivariate logistic regression model, accounting for clustering effects within countries and health facilities. MAIN OUTCOME MEASURES: Severe maternal outcomes and preterm birth, fetal mortality, early neonatal mortality, perinatal mortality, low birthweight, and neonatal intensive care unit admission. RESULTS: Amongst 314 623 included women, 2822 were reported to suffer from severe maternal outcomes, out of which 20.9% (589/2822; 95% CI 20.1-21.6%) were associated with indirect causes. The most common indirect cause was anaemia (50%). Women with underlying indirect causes showed significantly higher risk of obstetric complications (adjusted odds ratio, aOR, 7.0; 95% CI 6.6-7.4), severe maternal outcomes (aOR 27.9; 95% CI 24.7-31.6), and perinatal mortality (aOR 3.8; 95% CI 3.5-4.1). CONCLUSIONS: Indirect causes were responsible for about one-fifth of severe maternal outcomes. Women with underlying indirect causes had significantly increased risks of severe maternal and perinatal outcomes.

Pregnancy and childbirth outcomes among adolescent mothers: a World Health Organization multicountry study.

OBJECTIVE: To investigate the risk of adverse pregnancy outcomes among adolescents in 29 countries. DESIGN: Secondary analysis using facility-based cross-sectional data of the World Health Organization Multicountry Survey on Maternal and Newborn Health. SETTING: Twenty-nine countries in Africa, Latin America, Asia and the Middle East. POPULATION: Women admitted for delivery in 359 health facilities during 2-4 months between 2010 and 2011. METHODS: Multilevel logistic regression models were used to estimate the association between young maternal age and adverse pregnancy outcomes. MAIN OUTCOME MEASURES: Risk of adverse pregnancy outcomes among adolescent mothers. RESULTS: A total of 124 446 mothers aged ≤24 years and their infants were analysed. Compared with mothers aged 20-24 years, adolescent mothers aged 10-19 years had higher risks of eclampsia, puerperal endometritis, systemic infections, low birthweight, preterm delivery and severe neonatal conditions. The increased risk of intra-hospital early neonatal death among infants born to adolescent mothers was reduced and statistically insignificant after adjustment for gestational age and birthweight, in addition to maternal characteristics, mode of delivery and congenital malformation. The coverage of prophylactic uterotonics, prophylactic antibiotics for caesarean section and antenatal corticosteroids for preterm delivery at 26-34 weeks was significantly lower among adolescent mothers. CONCLUSIONS: Adolescent pregnancy was associated with higher risks of adverse pregnancy outcomes. Pregnancy prevention strategies and the improvement of healthcare interventions are crucial to reduce adverse pregnancy outcomes among adolescent women in low- and middle-income countries.

Advanced maternal age and pregnancy outcomes: a multicountry assessment.

OBJECTIVE: To assess the association between advanced maternal age (AMA) and adverse pregnancy outcomes. DESIGN: Secondary analysis of the facility-based, cross-sectional data of the WHO Multicountry Survey on Maternal and Newborn Health. SETTINGS: A total of 359 health facilities in 29 countries in Africa, Asia, Latin America, and the Middle East. SAMPLE: A total of 308 149 singleton pregnant women admitted to the participating health facilities. METHODS: We estimated the prevalence of pregnant women with advanced age (35 years or older). We calculated adjusted odds ratios of individual severe maternal and perinatal outcomes in these women, compared with women aged 20-34 years, using a multilevel, multivariate logistic regression model, accounting for clustering effects within countries and health facilities. The confounding factors included facility and individual characteristics, as well as country (classified by maternal mortality ratio level). MAIN OUTCOME MEASURES: Severe maternal adverse outcomes, including maternal near miss (MNM), maternal death (MD), and severe maternal outcome (SMO), and perinatal outcomes, including preterm birth (<37 weeks of gestation), stillbirths, early neonatal mortality, perinatal mortality, low birthweight (<2500 g), and neonatal intensive care unit (NICU) admission. RESULTS: The prevalence of pregnant women with AMA was 12.3% (37 787/308 149). Advanced maternal age significantly increased the risk of maternal adverse outcomes, including MNM, MD, and SMO, as well as the risk of stillbirths and perinatal mortalities. CONCLUSIONS: Advanced maternal age predisposes women to adverse pregnancy outcomes. The findings of this study would facilitate antenatal counselling and management of women in this age category.

Maternal complications and perinatal mortality: findings of the World Health Organization Multicountry Survey on Maternal and Newborn Health.

OBJECTIVE: We aimed to determine the prevalence and risks of late fetal deaths (LFDs) and early neonatal deaths (ENDs) in women with medical and obstetric complications. DESIGN: Secondary analysis of the WHO Multicountry Survey on Maternal and Newborn Health (WHOMCS). SETTING: A total of 359 participating facilities in 29 countries. POPULATION: A total of 308 392 singleton deliveries. METHODS: We reported on perinatal indicators and determined risks of perinatal death in the presence of severe maternal complications (haemorrhagic, infectious, and hypertensive disorders, and other medical conditions). MAIN OUTCOME MEASURES: Fresh and macerated LFDs (defined as stillbirths ≥ 1000 g and/or ≥28 weeks of gestation) and ENDs. RESULTS: The LFD rate was 17.7 per 1000 births; 64.8% were fresh stillbirths. The END rate was 8.4 per 1000 liveborns; 67.1% occurred by day 3 of life. Maternal complications were present in 22.9, 27.7, and 21.2% [corrected] of macerated LFDs, fresh LFDs, and ENDs, respectively. The risks of all three perinatal mortality outcomes were significantly increased with placental abruption, ruptured uterus, systemic infections/sepsis, pre-eclampsia, eclampsia, and severe anaemia. CONCLUSIONS: Preventing intrapartum-related perinatal deaths requires a comprehensive approach to quality intrapartum care, beyond the provision of caesarean section. Early identification and management of women with complications could improve maternal and perinatal outcomes.

Impact of increasing capacity for generating and using research on maternal and perinatal health practices in South East Asia (SEA-ORCHID Project).

BACKGROUND: Maternal and neonatal mortality and morbidity remain unacceptably high in many low and middle income countries. SEA-ORCHID was a five year international collaborative project in South East Asia which aimed to determine whether health care and health outcomes for mothers and babies could be improved by developing capacity for research generation, synthesis and use. METHODS: Nine hospitals in Indonesia, Malaysia, the Philippines and Thailand participated in SEA-ORCHID. These hospitals were supported by researchers from three Australian centres. Health care practices and outcomes were assessed for 1000 women at each hospital both before and after the intervention. The capacity development intervention was tailored to the needs and context of each hospital and delivered over an 18 month period. Main outcomes included adherence to forms of care likely to be beneficial and avoidance of forms of care likely to be ineffective or harmful. RESULTS: We observed substantial variation in clinical practice change between sites. The capacity development intervention had a positive impact on some care practices across all countries, including increased family support during labour and decreased perineal shaving before birth, but in some areas there was no significant change in practice and a few beneficial practices were followed less often. CONCLUSION: The results of SEA-ORCHID demonstrate that investing in developing capacity for research use, synthesis and generation can lead to improvements in maternal and neonatal health practice and highlight the difficulty of implementing evidence-based practice change.

Rapid versus stepwise application of negative pressure in vacuum extraction-assisted vaginal delivery: a multicentre randomised controlled non-inferiority trial.

OBJECTIVE: To evaluate whether the application of rapid negative pressure for vacuum-assisted delivery is as effective and safe as the stepwise method. DESIGN: Randomised controlled trial. SETTING: Six centres, including university, secondary and tertiary hospitals, in Thailand. SAMPLE: In total, 662 women were randomised to rapid and stepwise groups, with 331 women in each group. METHODS: Vacuum extraction was performed by applying a metal cup (Malmstrom) connected to an electric pump to the fetal head. The stepwise method consisted of four incremental steps of 0.2 kg/cm² every 2 minutes to obtain a final negative pressure of 0.8 kg/cm². In the rapid method the negative pressure of 0.8 kg/cm² was applied in one step in < 2 minutes. MAIN OUTCOME MEASURES: Success rate of vacuum extraction, vacuum cup detachment rate, duration of vacuum extraction, and maternal and neonatal complications. RESULTS: There were no significant differences in detachment rates (RD 0.3%, 95% CI -3.1 to 2.4). The overall success rates were identical, at 98.2%. There were significant reductions in the time between applying the vacuum cup and attaining maximum negative pressure (MD -4.6 minutes; 95% CI -4.4 to -4.8 minutes), and in the time between applying the cup and delivery (MD -4.4 minutes; 95% CI -4.8 to -4.0 minutes). There was a significantly higher rate of perineal suture in the rapid method group (RD 4.5%; 95% CI 1.1-8.2). There were no significant differences in maternal and fetal morbidities. CONCLUSIONS: Rapid negative pressure vacuum extraction could be performed as effectively and safely as the stepwise method, in a shorter period of time.

Caesarean section without medical indications is associated with an increased risk of adverse short-term maternal outcomes: the 2004-2008 WHO Global Survey on Maternal and Perinatal Health.

BACKGROUND: There is worldwide debate about the appropriateness of caesarean sections performed without medical indications. In this analysis, we aim to further investigate the relationship between caesarean section without medical indication and severe maternal outcomes. METHODS: This is a multicountry, facility-based survey that used a stratified multistage cluster sampling design to obtain a sample of countries and health institutions worldwide. A total of 24 countries and 373 health facilities participated in this study. Data collection took place during 2004 and 2005 in Africa and the Americas and during 2007 and 2008 in Asia. All women giving birth at the facility during the study period were included and had their medical records reviewed before discharge from the hospital. Univariate and multilevel analysis were performed to study the association between each group's mode of delivery and the severe maternal and perinatal outcome. RESULTS: A total of 286,565 deliveries were analysed. The overall caesarean section rate was 25.7% and a total of 1.0 percent of all deliveries were caesarean sections without medical indications, either due to maternal request or in the absence of other recorded indications. Compared to spontaneous vaginal delivery, all other modes of delivery presented an association with the increased risk of death, admission to ICU, blood transfusion and hysterectomy, including antepartum caesarean section without medical indications (Adjusted Odds Ratio (Adj OR), 5.93, 95% Confidence Interval (95% CI), 3.88 to 9.05) and intrapartum caesarean section without medical indications (Adj OR, 14.29, 95% CI, 10.91 to 18.72). In addition, this association is stronger in Africa, compared to Asia and Latin America. CONCLUSIONS: Caesarean sections were associated with an intrinsic risk of increased severe maternal outcomes. We conclude that caesarean sections should be performed when a clear benefit is anticipated, a benefit that might compensate for the higher costs and additional risks associated with this operation.

Use of evidence-based practices in pregnancy and childbirth: South East Asia Optimising Reproductive and Child Health in Developing Countries project.

BACKGROUND: The burden of mortality and morbidity related to pregnancy and childbirth remains concentrated in developing countries. SEA-ORCHID (South East Asia Optimising Reproductive and Child Health In Developing countries) is evaluating whether a multifaceted intervention to strengthen capacity for research synthesis, evidence-based care and knowledge implementation improves adoption of best clinical practice recommendations leading to better health for mothers and babies. In this study we assessed current practices in perinatal health care in four South East Asian countries and determined whether they were aligned with best practice recommendations. METHODOLOGY/PRINCIPAL FINDINGS: We completed an audit of 9550 medical records of women and their 9665 infants at nine hospitals; two in each of Indonesia, Malaysia and The Philippines, and three in Thailand between January-December 2005. We compared actual clinical practices with best practice recommendations selected from the Cochrane Library and the World Health Organization Reproductive Health Library. Evidence-based components of the active management of the third stage of labour and appropriately treating eclampsia with magnesium sulphate were universally practiced in all hospitals. Appropriate antibiotic prophylaxis for caesarean section, a beneficial form of care, was practiced in less than 5% of cases in most hospitals. Use of the unnecessary practices of enema in labour ranged from 1% to 61% and rates of episiotomy for vaginal birth ranged from 31% to 95%. Other appropriate practices were commonly performed to varying degrees between countries and also between hospitals within the same country. CONCLUSIONS/SIGNIFICANCE: Whilst some perinatal health care practices audited were consistent with best available evidence, several were not. We conclude that recording of clinical practices should be an essential step to improve quality of care. Based on these findings, the SEA-ORCHID project team has been developing and implementing interventions aimed at increasing compliance with evidence-based clinical practice recommendations to improve perinatal practice in South East Asia.

Azithromycin for acute lower respiratory tract infections.

BACKGROUND: Acute lower respiratory tract infections (LRTI) range from acute bronchitis and acute exacerbations of chronic bronchitis to pneumonia. Approximately five million people die of acute respiratory tract infections annually. Among these, pneumonia represents the most frequent cause of mortality, hospitalization and medical consultation. Azithromycin is a new macrolide antibiotic, structurally modified from erythromycin and noted for its activity against some gram-negative organisms associated with respiratory tract infections, particularly Haemophilus influenzae (H. influenzae). OBJECTIVES: To compare the effectiveness of azithromycin to amoxycillin or amoxycillin/clavulanic acid (amoxyclav) in the treatment of LRTI, in terms of clinical failure, incidence of adverse events and microbial eradication. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2007 Issue 2), MEDLINE (January 1966 to July 2007), and EMBASE (January 1974 to July 2007). SELECTION CRITERIA: Randomized and quasi-randomized controlled trials, comparing azithromycin to amoxycillin or amoxycillin/clavulanic acid in participants with clinical evidence of acute LRTI: acute bronchitis, pneumonia, and acute exacerbation of chronic bronchitis were studied. DATA COLLECTION AND ANALYSIS: The criteria for assessing study quality were generation of allocation sequence, concealment of treatment allocation, blinding, and completeness of the trial. All types of acute LRTI were initially pooled in the meta-analyses. The heterogeneity of results was investigated by the forest plot and Chi-square test. Index of I-square (I(2)) was also used to measure inconsistent results among trials. Subgroup and sensitivity analyses were conducted. MAIN RESULTS: Fifteen trials were analysed. The pooled analysis of all trials showed that there was no significant difference in the incidence of clinical failure on about day 10 to 14 between the two groups (relative risk (RR), random-effects 1.09; 95% confidence interval (CI) 0.64 to 1.85). Sensitivity analysis showed a reduction of clinical failure in azithromycin-treated participants (RR 0.55; 95% CI 0.25 to 1.21) in three adequately concealed studies, compared to RR 1.32; 95% CI 0.70 to 2.49 in 12 studies with inadequate concealment. Twelve trials reported the incidence of microbial eradication and there was no significant difference between the two groups (RR 0.95; 95% CI 0.87 to 1.03). The reduction of adverse events in the azithromycin group was RR 0.76 (95% CI 0.57 to 1.00). AUTHORS' CONCLUSIONS: There is unclear evidence that azithromycin is superior to amoxicillin or amoxyclav in treating acute LRTI. In patients with acute bronchitis of a suspected bacterial cause, azithromycin tends to be more effective in terms of lower incidence of treatment failure and adverse events than amoxicillin or amoxyclav. Future trials of high methodological quality are needed.

Arthroscopic debridement for knee osteoarthritis.

BACKGROUND: Knee osteoarthritis (OA) is a progressive disease that initially affects the articular cartilage. Observational studies have shown benefits for arthroscopic debridement (AD) on the osteoarthritic knee, but other recent studies have yielded conflicting results that suggest AD may not be effective. OBJECTIVES: To identify the effectiveness of AD in knee OA on pain and function. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 2, 2006); MEDLINE (1966 to August, 2006); CINAHL (1982 to 2006); EMBASE (1988 to 2006) and Web of Science (1900 to 2006) and screened the bibliographies, reference lists and cited web sites of papers. SELECTION CRITERIA: We included randomised controlled trials (RCT) or controlled clinical trials (CCT) assessing effectiveness of AD compared to another surgical procedure, including sham or placebo surgery and other non-surgical interventions, in patients with a diagnosis of primary or secondary OA of the knees, who did not have other joint involvement or conditions requiring long term use of non-steroidal anti-inflammatory drugs (NSAIDs). The main outcomes were pain relief and improved function of the knee. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials for inclusion, assessed trial quality and extracted the data. Results are presented using weighted mean difference (WMD) for continuous data and relative risk (RR) for dichotomous data, and the number needed to treat to benefit (NNTB) or harm (NNTH). MAIN RESULTS: Three RCTs were included with a total of 271 patients. They had different comparison groups and a moderate risk of bias. One study compared AD with lavage and with sham surgery. Compared to lavage the study found no significant difference. Compared to sham surgery placebo, the study found worse outcomes for AD at two weeks (WMD for pain 8.7, 95% CI 1.7 to 15.8, and function 7.7, 95% CI 1.1 to 14.3; NNTH=5) and no significant difference at two years. The second trial, at higher risk of bias, compared AD and arthroscopic washout, and found that AD significantly reduced knee pain compared to washout at five years (RR 5.5, 95% CI 1.7 to 15.5; NNTB=3). The third trial, also at higher risk of bias, compared AD to closed-needle lavage, and found no significant difference. AUTHORS' CONCLUSIONS: There is 'gold' level evidence that AD has no benefit for undiscriminated OA (mechanical or inflammatory causes).

Prophylactic antibiotics for transcervical intrauterine procedures.

BACKGROUND: The transcervical intrauterine route is commonly used for operative gynecological procedures in women. The vagina is an area of the body that is abundant with normal bacterial flora. An operative procedure through the vagina may, therefore, be considered to have added potential for resulting in post-procedure infection. Prophylactic antibiotics may play a role in the prevention of post-procedure transcervical intrauterine infections. OBJECTIVES: To assess the effectiveness and safety of antibiotic prophylaxis compared to placebo or no treatment in women undergoing transcervical intrauterine procedures. SEARCH STRATEGY: The search strategy was based on the Menstrual Disorders and Subfertility Group's search strategy. The following databases were searched:Menstrual Disorders and Subfertility Group Specialized Register;Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library 2006, Issue 4;MEDLINE (1966 to November 2006);EMBASE (1966 to November 2006);Biological Abstracts (1966 to October 2006);AMED (1966 to November 2006). Key words were prepared, in consultation with the Trials Search Coordinator, according to the terms related to our objective: antibiotic, antibiotics, prophylaxis, transvaginal, transcervical intrauterine, endometrial sample, endometrium sampling, endometrial biopsy, hysterosalpingography, hysteroscope, hysteroscopy, hysteroscopic surgery, endometrial ablation, and endometrial resection. SELECTION CRITERIA: The review authors planned to include only truly randomized controlled trials that compared antibiotic prophylaxis with placebo or no treatment in order to prevent infectious complications after transcervical intrauterine procedures. Controlled clinical trials without randomization and pseudo-randomized trial were excluded. DATA COLLECTION AND ANALYSIS: No data collection or analysis was done because no trials were eligible for inclusion in the review. MAIN RESULTS: The search did not identify any randomized controlled trials investigating the effect of antibiotic prophylaxis compared to placebo or no treatment in women undergoing transcervical intrauterine procedures. AUTHORS' CONCLUSIONS: At this time, there are no published randomized controlled trials that assess prophylactic antibiotics effects on infectious complications following transcervical intrauterine procedures. It is, therefore, not possible to draw any conclusions regarding the use of prophylactic antibiotics for the prevention of post-procedure transcervical intrauterine infections.

Prophylactic antibiotics for manual removal of retained placenta in vaginal birth.

BACKGROUND: Retained placenta is a potentially life-threatening condition because of its association with postpartum haemorrhage. Manual removal of placenta increases the likelihood of bacterial contamination in the uterine cavity. OBJECTIVES: To compare the effectiveness and side-effects of routine antibiotic use for manual removal of placenta in vaginal birth in women who received antibiotic prophylaxis and those who did not and to identify the appropriate regimen of antibiotic prophylaxis for this procedure. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group Trials Register (30 November 2005), CENTRAL (The Cochrane Library, Issue 4, 2005), MEDLINE (from 1966 to January 2005), EMBASE (from 1980 to January 2005), CINAHL (from 1982 to January 2005) and LILACS (from 1982 to January 2005). SELECTION CRITERIA: All randomized controlled trials comparing antibiotic prophylaxis and placebo or non antibiotic use to prevent endometritis after manual removal of placenta in vaginal birth. DATA COLLECTION AND ANALYSIS: If eligible trials were to be identified, trial quality would be assessed and data would be extracted, unblinded by two review authors independently. MAIN RESULTS: No studies that met the inclusion criteria were identified. AUTHORS' CONCLUSIONS: There are no randomized controlled trials to evaluate the effectiveness of antibiotic prophylaxis to prevent endometritis after manual removal of placenta in vaginal birth.

Meditation therapy for anxiety disorders.

BACKGROUND: Anxiety disorders are characterised by long term worry, tension, nervousness, fidgeting and symptoms of autonomic system hyperactivity. Meditation is an age-old self regulatory strategy which is gaining more interest in mental health and psychiatry. Meditation can reduce arousal state and may ameliorate anxiety symptoms in various anxiety conditions. OBJECTIVES: To investigate the effectiveness of meditation therapy in treating anxiety disorders SEARCH STRATEGY: Electronic databases searched include CCDANCTR-Studies and CCDANCTR-References, complementary and alternative medicine specific databases, Science Citation Index, Health Services/Technology Assessment Text database, and grey literature databases. Conference proceedings, book chapters and references were checked. Study authors and experts from religious/spiritual organisations were contacted. SELECTION CRITERIA: Types of studies: Randomised controlled trials. TYPES OF PARTICIPANTS: patients with a diagnosis of anxiety disorders, with or without another comorbid psychiatric condition. Types of interventions: concentrative meditation or mindfulness meditation. Comparison conditions: one or combination of 1) pharmacological therapy 2) other psychological treatment 3) other methods of meditation 4) no intervention or waiting list. Types of outcome: 1) improvement in clinical anxiety scale 2) improvement in anxiety level specified by triallists, or global improvement 3) acceptability of treatment, adverse effects 4) dropout. DATA COLLECTION AND ANALYSIS: Data were independently extracted by two reviewers using a pre-designed data collection form. Any disagreements were discussed with a third reviewer, and the authors of the studies were contacted for further information. MAIN RESULTS: Two randomised controlled studies were eligible for inclusion in the review. Both studies were of moderate quality and used active control comparisons (another type of meditation, relaxation, biofeedback). Anti-anxiety drugs were used as standard treatment. The duration of trials ranged from 3 months (12 weeks) to 18 weeks. In one study transcendental meditation showed a reduction in anxiety symptoms and electromyography score comparable with electromyography-biofeedback and relaxation therapy. Another study compared Kundalini Yoga (KY), with Relaxation/Mindfulness Meditation. The Yale-Brown Obsessive Compulsive Scale showed no statistically significant difference between groups. The overall dropout rate in both studies was high (33-44%). Neither study reported on adverse effects of meditation. AUTHORS' CONCLUSIONS: The small number of studies included in this review do not permit any conclusions to be drawn on the effectiveness of meditation therapy for anxiety disorders. Transcendental meditation is comparable with other kinds of relaxation therapies in reducing anxiety, and Kundalini Yoga did not show significant effectiveness in treating obsessive-compulsive disorders compared with Relaxation/Meditation. Drop out rates appear to be high, and adverse effects of meditation have not been reported. More trials are needed.

Efficacy of pilocarpine lozenge for post-radiation xerostomia in patients with head and neck cancer.

BACKGROUND: Patients with radiation-induced xerostomia produce little or no saliva. Several studies have demonstrated the efficacy of systemic administration of pilocarpine hydrochloride in individuals with post-radiation xerostomia. However, analysis of pilocarpine lozenges for treatment of post-radiation xerostomia in patients with head and neck cancer has not been reported. METHODS: The aim of this study was to quantify improvement in clinical symptoms and salivary function after treatment of post-radiation xerostomia with pilocarpine lozenges. In a double-blinded, placebo-controlled trial, 33 head and neck cancer patients were assigned randomly to receive Salagen tablet, pilocarpine hydrochloride lozenge (3 or 5 mg) or placebo lozenge every 10 days. At each visit, a subjective evaluation was undertaken through the use of visual analog scales before and at 180 minutes after treatment. Whole resting saliva was collected before and at 0, 30, 60, 90, 120, 150 and 180 minutes after treatment. RESULTS: The percentage of patients with decreased feeling of oral dryness, sore mouth or speaking difficulties after taking 5-mg pilocarpine lozenge was greater than Salagen or placebo. There were statistically significant increases in salivary production in pilocarpine treatment groups vs. placebo (P < 0.05). CONCLUSION: The 5-mg pilocarpine lozenge produced the best clinical results, but further investigation with a larger group of patients is required.

Azithromycin for acute lower respiratory tract infections.

BACKGROUND: The spectrum of acute lower respiratory tract infection ranges from acute bronchitis and acute exacerbations of chronic bronchitis to pneumonia. Annually approximately five million people die of acute respiratory tract infections. Among these, pneumonia represents the most frequent cause of mortality, hospitalization and medical consultation. Azithromycin is a new macrolide antibiotic, structurally modified from erythromycin and is noted for its activity against some gram-negative organisms associated with respiratory tract infections, particularly Haemophilus influenzae (H. influenzae). OBJECTIVES: To compare the effectiveness of azithromycin to amoxycillin or amoxycillin/clavulanic acid (amoxyclav) in the treatment of LRTI, in terms of clinical failure, incidence of adverse events and microbial eradication. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 4, 2003), MEDLINE (January 1966 to January Week 3, 2004), and EMBASE (January 1988 to 2003). SELECTION CRITERIA: Randomised and quasi-randomised controlled trials, which compared azithromycin to amoxycillin or amoxycillin/clavulanic acid in patients with clinical evidence of acute LRTI: acute bronchitis, pneumonia, and acute exacerbation of chronic bronchitis were studied. DATA COLLECTION AND ANALYSIS: The criteria for assessing study quality were generation of allocation sequence, concealment of treatment allocation, blinding, and completeness of the trial. All types of acute lower respiratory tract infections were initially pooled in the meta-analyses. Funnel plot was used to examine publication bias. The heterogeneity of results was investigated by the forest plot and Chi-square test. Index of I(2) was also used to measure inconsistency results among trials. Subgroup analysis was conducted for age, types of respiratory tract infection and types of antibiotic in control groups. Sensitivity analysis was conducted under the condition of trial size and concealment of treatment allocation. MAIN RESULTS: Fourteen trials with 2,521 enrolled patients used 2,416 patients in the analysis. A total of 1,350 patients received azithromycin and 1,066 received amoxicillin or amoxicillin-clavulanic acid. The pooled analysis of all trials showed that there was no significant difference in the incidence of clinical failure on about day 10 to 14 after therapy started between the two groups (relative risk (RR) (random effects) 0.96; 95% CI 0.58 to 1.57). Sensitivity analysis showed that a reduction of clinical failure in azithromycin-treated patients (RR 0.52; 95% CI 0.24 to 1.12) in three adequately concealed studies, compared to RR 1.14 (95% CI 0.62 to 2.08) in eleven studies with inadequate concealment. Eleven trials reported the incidence of microbial eradication and there was no significant difference between the two groups (RR 0.98; 95% CI 0.91 to 1.07). The reduction of adverse events in azithromycin group was RR 0.75 (95% CI 0.56 to 1.00). REVIEWERS' CONCLUSIONS: There is unclear evidence that azithromycin is superior to amoxicillin or amoxicillin-clavulanic acid in treating acute LRTI. Future trials with high methodological quality are needed.

Meta-analyses involving cluster randomization trials: a review of published literature in health care.

Throughout the 1980s and 1990s cluster randomization trials have been increasingly used to evaluate effectiveness of health care intervention. Such trials have raised several methodologic challenges in analysis. Meta-analyses involving cluster randomization trials are becoming common in the area of health care intervention. However, as yet there has been no empirical evidence of current practice in the meta-analyses. Thus a review was performed to identify and examine synthesis approaches of meta-analyses involving cluster randomization trials in the published literature. Electronic databases were searched for meta-analyses involving cluster randomization trials from the earliest date available to 2000. Once a meta-analysis was identified, papers on the relevant cluster randomization trials included were also requested. Each of the original papers of cluster randomization trials included was examined for its randomized design and unit, and adjustment for clustering effect in analysis. Each of the selected meta-analyses was then evaluated as to its synthesis concerning clustering effect. In total, 25 eligible meta-analyses were reviewed. Of these, 15 meta-analyses reported simple conventional methods of the fixed-effect model as method of analysis, while six did not incorporate the cluster randomization trial results in the synthesis methods but described the trial results individually. Three meta-analyses attempted to account for the clustering effect in the synthesis methods but approaches were in arbitrary. Fifteen meta-analyses included more than one cluster randomization trial, each of which included cluster randomization trials with a mixture of randomized designs and units, and units of analysis. These mixture situations might increase heterogeneity, but have not been considered in any meta-analysis. Some methods dealing with a binary outcome for some specific situations have been discussed. In conclusion, some difficulties in the quantitative synthesis procedures were found in the meta-analyses involving cluster randomization trials. Recommendations in the applications of approaches to some specific situations in a binary outcome variable have also been provided. There are still, however, several methodologic issues of the meta-analyses involving cluster randomization trials that need to be investigated further.

Incidence of childhood type 1 (insulin dependent) diabetes mellitus in northeastern Thailand.

The incidence of type 1 (insulin dependent) diabetes mellitus in children under 15 years from northeastern Thailand was reported. Data of new cases from 1991 to 1995 were collected retrospectively by a mail survey from 257 government hospitals in the northeastern part of Thailand. The incidence rate of type 1 (insulin dependent) diabetes mellitus was 0.3/100,000 (95% confidence interval [CI] = 0.24-0.38). The incidence rate in girls was 2 fold that of boys. More than half of the cases were diagnosed between the ages of 10 and 14. These data indicated that incidence of childhood type 1 diabetes mellitus in Thailand is one of the lowest in the world.

Long term results of botulinum toxin type A (Dysport) in the treatment of hemifacial spasm: a report of 175 cases.

OBJECTIVE: To describe the long term efficacy and side effects of the treatment of hemifacial spasm with Dysport and to evaluate two different sites of injection to hopefully reduce side effects. METHODS: This study was designed as a prospective descriptive study. Injections were made subcutaneously around the eye. Peak improvement was subjectively assessed by using a visual analogue scale and reported in percentages (0-100%). Duration of improvement was assessed subjectively and reported in months. RESULTS: Of 175 cases, 17 were lost to follow up and were excluded. 855 treatments were injected in the remaining 158 patients with a median of 4 treatments. The response rate was 97%. Of 855 treatments, the adjusted mean peak and duration of improvement was 77.2 (95% confidence interval (95%CI) 74.7-79.4)% and 3.4 (95%CI 3.2-3.6) months respectively. In 158 patients (complete group), the long term results from the first to the 12th treatment showed that the mean peak improvement ranged from 72.70 to 80.10% and the duration of improvement was 2.60 to 3.71 months. It remained constant throughout (p=0.40, p=0.87 respectively). The most common side effect was ptosis. Of the 158 patients, 21 completed 12 treatments (subgroup). A separate analysis of this group disclosed a mean peak and duration of improvement from the first to 12th treatments ranging from 70.00 to 78.10% and 2.65 to 4.31 months respectively. Analysis of variance with repeated measures showed no significant variation of peak and duration of improvement over the first to the 12th treatments (p=0.38, p=0.38 respectively). Only 3% of the treatments were unsuccessful but responded to subsequent treatments. The incidence of ptosis was reduced from 27.17% to 9.68% by moving the injection site to the lateral part of orbital orbicularis oculi without any loss of efficacy. The yearly cost of Dysport is considerably less than Botox. CONCLUSION: This study is the first to show, in detail, the long term results of treatments of hemifacial spasm with Dysport. The efficacy is constant throughout orbicularis oculi. The efficacy of Dysport is comparable with Botox in long term follow up.

Doctors' statistical literacy: a survey at Srinagarind Hospital, Khon Kaen University.

Medical doctors need to keep abreast of new developments in medicine. This is often done by reading medical journals and carrying out research activities that require an understanding of statistical methods. This study was designed to assess the knowledge of statistics among doctors in Thailand. A pretested, self-administered questionnaire with nine multiple-choice questions on basic statistical issues was used. In a survey of university hospital staff, there were 365 doctors, including 156 specialists, 152 residents and 57 final year medical students (externs). The overall response rate was 40.0 per cent. The overall median number of correct answers was 4.0 (95% CI 3.0, 4.0). Specialists had a significantly higher median score, 4.0 than residents, and externs, 3.0's, (p = 0.02). Respondents who had previously attended statistical workshops had a significantly higher median score (5.0) than those who had not (3.0) (p < 0.01). These results indicate that doctors in our hospital have insufficient knowledge of the basic statistical concepts that are commonly used in medical journals. Continuing education in statistics for doctors during residency and post doctoral training must be given serious consideration.