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Background Miscarriage, defined as the spontaneous loss of a pregnancy before 24 weeks' gestation, is common with approximately 25% of women experiencing a miscarriage in their lifetime. An estimated 15% of pregnancies end in miscarriage. Miscarriage can lead to serious morbidity, including haemorrhage, infection, and even death, particularly in settings without adequate healthcare provision. Early miscarriages occur during the first 14 weeks of pregnancy, and can be managed expectantly, medically or surgically. However, there is uncertainty about the relative effectiveness and risks of each option. Objectives To estimate the relative effectiveness and safety profiles for the different management methods for early miscarriage, and to provide rankings of the available methods according to their effectiveness, safety, and side-effect profile using a network meta-analysis. Search methods We searched the Cochrane Pregnancy and Childbirth's Trials Register (9 February 2021), ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) (12 February 2021), and reference lists of retrieved studies. Selection criteria We included all randomised controlled trials assessing the effectiveness or safety of methods for miscarriage management. Early miscarriage was defined as less than or equal to 14 weeks of gestation, and included missed and incomplete miscarriage. Management of late miscarriages after 14 weeks of gestation (often referred to as intrauterine fetal deaths) was not eligible for inclusion in the review. Cluster- and quasi-randomised trials were eligible for inclusion. Randomised trials published only as abstracts were eligible if sufficient information could be retrieved. We excluded non-randomised trials. Data collection and analysis At least three review authors independently assessed the trials for inclusion and risk of bias, extracted data and checked them for accuracy. We estimated the relative effects and rankings for the primary outcomes of complete miscarriage and composite outcome of death or serious complications. The certainty of evidence was assessed using GRADE. Relative effects for the primary outcomes are reported subgrouped by the type of miscarriage (incomplete and missed miscarriage). We also performed pairwise meta-analyses and network meta-analysis to determine the relative effects and rankings of all available methods. Main results Our network meta-analysis included 78 randomised trials involving 17,795 women from 37 countries. Most trials (71/78) were conducted in hospital settings and included women with missed or incomplete miscarriage. Across 158 trial arms, the following methods were used: 51 trial arms (33%) used misoprostol; 50 (32%) used suction aspiration; 26 (16%) used expectant management or placebo; 17 (11%) used dilatation and curettage; 11 (6%) used mifepristone plus misoprostol; and three (2%) used suction aspiration plus cervical preparation. Of these 78 studies, 71 (90%) contributed data in a usable form for meta-analysis. Complete miscarriage Based on the relative effects from the network meta-analysis of 59 trials (12,591 women), we found that five methods may be more effective than expectant management or placebo for achieving a complete miscarriage: · suction aspiration after cervical preparation (risk ratio (RR) 2.12, 95% confidence interval (CI) 1.41 to 3.20, low-certainty evidence), · dilatation and curettage (RR 1.49, 95% CI 1.26 to 1.75, low-certainty evidence), · suction aspiration (RR 1.44, 95% CI 1.29 to 1.62, low-certainty evidence), · mifepristone plus misoprostol (RR 1.42, 95% CI 1.22 to 1.66, moderate-certainty evidence), · misoprostol (RR 1.30, 95% CI 1.16 to 1.46, low-certainty evidence). The highest ranked surgical method was suction aspiration after cervical preparation. The highest ranked non-surgical treatment was mifepristone plus misoprostol. All surgical methods were ranked higher than medical methods, which in turn ranked above expectant management or placebo. Composite outcome of death and serious complications Based on the relative effects from the network meta-analysis of 35 trials (8161 women), we found that four methods with available data were compatible with a wide range of treatment effects compared with expectant management or placebo: · dilatation and curettage (RR 0.43, 95% CI 0.17 to 1.06, low-certainty evidence), · suction aspiration (RR 0.55, 95% CI 0.23 to 1.32, low-certainty evidence), · misoprostol (RR 0.50, 95% CI 0.22 to 1.15, low-certainty evidence), · mifepristone plus misoprostol (RR 0.76, 95% CI 0.31 to 1.84, low-certainty evidence). Importantly, no deaths were reported in these studies, thus this composite outcome was entirely composed of serious complications, including blood transfusions, uterine perforations, hysterectomies, and intensive care unit admissions. Expectant management and placebo ranked the lowest when compared with alternative treatment interventions. Subgroup analyses by type of miscarriage (missed or incomplete) agreed with the overall analysis in that surgical methods were the most effective treatment, followed by medical methods and then expectant management or placebo, but there are possible subgroup differences in the effectiveness of the available methods. AUTHORS' CONCLUSIONS: Based on relative effects from the network meta-analysis, all surgical and medical methods for managing a miscarriage may be more effective than expectant management or placebo. Surgical methods were ranked highest for managing a miscarriage, followed by medical methods, which in turn ranked above expectant management or placebo. Expectant management or placebo had the highest chance of serious complications, including the need for unplanned or emergency surgery. A subgroup analysis showed that surgical and medical methods may be more beneficial in women with missed miscarriage compared to women with incomplete miscarriage. Since type of miscarriage (missed and incomplete) appears to be a source of inconsistency and heterogeneity within these data, we acknowledge that the main network meta-analysis may be unreliable. However, we plan to explore this further in future updates and consider the primary analysis as separate networks for missed and incomplete miscarriage.

Acknowledgement: “This Protocol of a Cochrane Review was published in the Cochrane Database of Systematic Reviews 2020, Issue 9. Cochrane Protocols and Reviews are regularly updated as new evidence emerges and in response to feedback, and the Cochrane Database of Systematic Reviews should be consulted for the most recent version of the Protocol.'

Objective This systematic review aimed to evaluate the scientific evidence on the efficacy of desensitizing mouthwashes for the treatment of dentin hypersensitivity (DH) and root sensitivity (RS). Material and methods A thorough search in MEDLINE, PubMed and Cochrane Plus Library was conducted up to February 2015. Randomized clinical trials, parallel, double-blinded and placebo-controlled, with a follow-up of at least 6 weeks, reporting changes on response to tactile stimuli, thermal/evaporative stimuli or patients’ subjective assessment of the pain experienced during their daily life after the home use of desensitizing mouthwashes were considered for inclusion. Results The screening of titles and abstracts resulted in seven publications meeting the eligibility criteria. The desensitizing agents evaluated were potassium nitrate (n = 5), aluminium lactate (n = 1) and sodium fluoride (n = 1). A meta-analysis for each of the hypersensitivity stimuli was performed. Results demonstrated statistically significant reduction in sensitivity scores favouring test group when DH was assessed by means of patients’ self-reported pain experience (SMD at 8 weeks = 0.77; 95% CI [0.23; 1.31]; P = 0.005). No significant effects were detected in response to tactile or thermal/evaporative stimuli. Meta-regression analysis demonstrated a tendency towards an increased effect favouring test group for the patients’ subjective perception, whereas tactile and thermal/evaporative stimuli showed a slight tendency towards a reduction in the efficacy of the test mouthwash. Conclusions There exists a tendency towards a decrease in DH or RS scores with time in both treatment groups, with significant differences in favour of test group when sensitivity is evaluated in terms of patients’ self-reported sensitivity symptoms.

AIM The aim of this systematic review and network meta-analysis (NMA) was to compare the efficacy of different anti-plaque chemical agents, in 6-month, home-use, randomized clinical trials (RCTs), in terms of plaque index (PlI) changes. MATERIAL AND METHODS RCTs assessing PlI were identified, screened, and evaluated for inclusion. Relevant information was extracted, and quality and risk of bias were assessed. Mean differences between baseline-end were calculated to obtain weighted mean differences and 95% confidence intervals. NMA protocols were applied to assess direct and indirect comparisons among products using Turesky PlI. RESULTS Eighty-three papers were included: 49 examined dentifrices, 32 mouthrinses and 2 both. The NMA analysed 51 studies including data from 4242 and 4180 subjects for dentifrices and mouthrinses respectively. For dentifrices, triclosan-copolymer and chlorhexidine showed the greatest effect, with significant differences when compared with stannous fluoride. For mouthrinses, essential oils and chlorhexidine showed the greatest effect, with significant differences when compared with delmopinol, alexidine and cetylpyridinium chloride. CONCLUSION Within the limitations of this study (including the severe imbalance in the amount of evidence), dentifrices containing triclosan-copolymer or chlorhexidine and mouthrinses containing essential oils or chlorhexidine showed the greatest effect on PlI scores as assessed with NMA.

Objective To estimate the incidence of caesarean scar pregnancy (CSP) and to describe the management outcomes associated with this condition. Design A national cohort study using the UK Early Pregnancy Surveillance Service (UKEPSS). Setting 86 participating Early Pregnancy Units. Population All women diagnosed in the participating units with CSP between November 2013 and January 2015. Methods Cohort study of women identified through the UKEPSS monthly mailing system. Main outcome measures Incidence, clinical outcomes and complications. Results 102 cases of CSP were reported, with an estimated incidence of 1.5 per 10 000 (95% CI 1.1-1.9) maternities. Full outcome data were available for 92 women. Management was expectant in 21/92 (23%), medical in 15/92 (16%) and surgical in 56/92 (61%). The success rates of expectant, medical and surgical management were 43% (9/21), 46% (7/15) and 96% (54/56), respectively. The complication rates were 15/21 (71%) with expectant, 9/15 (60%) with medical and 20/56 (36%) with surgical management. Discharge from care (median number of days) was 82 (range 37-174) with expectant, 21 (range 10-31) with medical and 11 (range 4-49) with surgical management. Conclusions Surgical management appears to be associated with a high success rate, low complication rate and short post-treatment follow up. Tweetable abstract Surgery for CSP appears to be successful, with low complication rates and short post-treatment follow up.

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: The objectives of this review are: to estimate the relative effectiveness and safety profiles for methods of management of miscarriage; to provide a ranking of the available methods according to their effectiveness and safety profile.

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: We aim to assess the clinical effectiveness and safety profile of currently applied controlled ovarian stimulation (COS) protocols, and to generate a clinically-useful ranking of these protocols.

Purpose Atomoxetine is a non-stimulant drug that could be an alternative to methylphenidate, whose benefit:risk balance for the treatment of adults with attention deficit hyperactivity disorder (ADHD) has recently been shown to be unclear. This study aimed to compare all-cause discontinuation rate between atomoxetine and placebo in adults with ADHD. Secondarily, efficacy and safety were investigated. Methods Systematic review and meta-analysis of randomized controlled trials comparing atomoxetine with placebo in adults with ADHD were performed. All-cause treatment discontinuation was the primary endpoint. Efficacy in reducing ADHD symptoms and safety were the secondary endpoints. Odds ratio (OR) and the standardized mean difference (SMD) were calculated for dichotomous and continuous outcomes, respectively. Data were pooled using the fixed and random effects model. The influence of study design-related, intervention-related and patient-related co-variables over the primary endpoint was investigated by means of meta-regression. This study is registered with the international prospective register of systematic reviews (PROSPERO): CRD 42012002042. Results Twelve studies (3375 patients) were included. Treatment discontinuation was larger with atomoxetine than with placebo (OR= 1.39). No co-variable was found to modify the effect of atomoxetine over treatment discontinuation. Atomoxetine showed modest efficacy in reducing ADHD symptoms irrespective of the assessor: patient (SMD=0.33); clinician (SMD=0.40). The rate of adverse events-induced discontinuation was higher with atomoxetine than with placebo (OR=2.57). Conclusion This study suggests that atomoxetine has a poor benefit–risk balance for the treatment of adults with ADHD. The recommendation of atomoxetine use in this population is weak. Copyright © 2013 John Wiley & Sons, Ltd. key words—attention deficit hyperactivity disorder; atomoxetine; discontinuation; efficacy; safety; meta-analysis; meta-regression; pharmacoepidemiology

Background Psychological illness occurring in association with hyperemesis gravidarum (HG) has been widely reported. Objective To determine if there is a higher incidence of psychological morbidity in women with HG compared with women without significant nausea and vomiting in pregnancy. Search strategy PubMed, MEDLINE, Embase and PsychINFO were searched up to September 2015. Selection criteria Articles referring to psychological morbidity in relation to HG. For meta-analysis case–control studies using numerical scales to compare psychological symptoms. Data collection and analysis Articles were independently assessed for inclusion by two reviewers and methodology was appraised using the Newcastle Ottawa Scale. Comparison was made using the standard mean difference (SMD) in symptom scale scores. Main results In all, 59 articles were included in the systematic review, 12 of these were used in the meta-analysis. Meta-analysis of depression scale scores demonstrated a very large effect with statistically significantly higher depression scale scores in women with HG (SMD 1.22; 95% CI 0.80–1.64; P ≤ 0.01) compared with controls. Meta-analysis of anxiety scores demonstrated a large effect with statistically significantly higher anxiety disorder scale scores in women with HG (SMD 0.86; 95% CI 0.53–1.19; P ≤ 0.01). In both analyses significant heterogeneity was identified (depression and HG I2 = 94%, P ≤ 0.01; anxiety and HG I2 = 84%, P = 0.02). Conclusions Our systematic review and meta-analysis have shown a significantly increased frequency of depression and anxiety in women with HG. The findings should prompt service development for women with HG that includes provision of psychological care and support. Tweetable abstract Meta-analysis demonstrates an increase in #PsychologicalMorbidity in women with #HyperemesisGravidarum

Background: Many studies have demonstrated a positive association between air pollutants and emergency visits for asthma. However, few studies have included pollen when analysing this relationship in mild–moderate asthmatic patients. Objective: To determine the importance of the pollutants such as ozone (O3), particles (PM10), nitrogen dioxide (NO2) and sulphur dioxide (SO2) in the clinical course of mild–moderate pollen-allergic asthmatic patients from two Spanish towns in La Mancha: Puertollano (high pollution levels) and Ciudad Real (low pollution levels). Methods: We used a Poisson regression model to study a cohort of 137 patients from Puertollano and Ciudad Real during two pollen seasons (2000–2001) and analysed the relationship between air pollutant and pollen levels and daily symptoms, the medication used and peak-flow measurements. Results: The number of asthma symptoms and the mean values of the PM10, SO2 and NO2 levels were higher in Puertollano than in Ciudad Real. In Puertollano, the risk of asthma increased by 6% with a 3-day lag for PM10, by 8% with a 3-day lag for O3, by 4% with a 1-day lag for SO2 and by 15% with a 3-day lag for O3 when its values exceeded the health threshold (P

Summary Background Allergic diseases have increased in industrialized countries and this increase is associated not only with genetic factors but also with lifestyle and environmental factors such as air pollution. Our hypothesis was that asthma in pollen-allergic patients from two towns with very different pollution levels in La Mancha (Spain) could be affected to a very different degree. Objective Our objectives were to assess the risk factors associated with decompensation of pollen-induced asthma in the two towns and to perform a comparison between the patients from Puertollano (high pollution level) and Ciudad Real (low pollution level) with respect to daily symptoms, medication used and peak-flow measurements. Methods We designed a cohort study with 137 patients (66 from Puertollano and 71 from Ciudad Real), conducted over 3 years (1999–2001) and including two pollen seasons. The two populations presented similar demographic and clinical characteristics. The variables studied included: area of residence, sex, age, smoking status, asthma symptoms and positive prick tests. Clinical decompensation was monitored by symptoms recorded on diary cards, twice daily peak-flow measurements and the use of protocolized medication. Results There was a clinically relevant relationship between the place of residence and clinical decompensation. The risk of clinical decompensation in patients from Puertollano was up to three times higher than that of patients in Ciudad Real (P=0.034). Furthermore, patients from Puertollano and patients with moderate asthma presented more rapid decompensation compared with patients from Ciudad Real (P=0.020) and patients with mild asthma (P=0.049). Conclusion In conclusion, pollen-allergic asthmatics in Puertollano present a poorer clinical course and become decompensated earlier than those from Ciudad Real and it could be due to air pollution.

The Parkinson's Disease Sleep Scale (PDSS) is the first published bedside clinical tool to specifically measure sleep disturbances in Parkinson's disease (PD). The objective of the present study was to carry out a metric analysis of a Spanish version (PDSS-SV) using a cross-sectional study of 100 PD patients who participated in the study. Usual measures for PD and mental status were applied by neurologists. Patients completed the Epworth Sleepiness Scale, Parkinson's Disease Questionnaire-39 Items (PDQ-39), and PDSS-SV. PDSS internal consistency (Cronbach's alpha, 0.77; significant item-total correlation for 11 items) was satisfactory. PDSS showed high test-retest reliability (intraclass correlation coefficient for items, 0.79-0.99; for total score, 0.94). Standard error of measurement was 9.80 (crossover) and 5.01 (longitudinal). Scores were distributed uniformly, with low floor and ceiling effect (1%). PDSS scores were correlated significantly with depression (Hamilton Depression Rating Scale, r(S) = -0.55; P < 0.0001) and quality of life (PDQ-39 Summary Index, r(S) = -0.26; P = 0.007), but not with clinical variables. Self-perception of mood disorder, pain, or hallucinations correlated individually with PDSS scores, and a factor explaining 65% of the variance was found. The assessment of PD sleep disorders with the PDSS met some basic standards required for health status measures.

This multicenter study sought to analyze the validity and reliability of the Unified Parkinson's Disease Rating Scale (UPDRS)-section 2 (Activities of Daily Living, ADL) as applied by patients and caregivers. Sixty pairs of PD patients-caregivers were enrolled for study purposes. Neurologists used a set of scales to determine disease severity and patients' functional state. Patients and caregivers used adapted versions of the UPDRS-section 2 in tandem with other measures. Wilcoxon and Mann-Whitney tests, weighted kappa, intraclass and Spearman's correlation coefficients, as well as multivariate linear regression models were applied. On the whole, PD patient self-assessment and caregiver evaluation of patients' disability showed close concordance with neurologists' ratings. Correlation between caregiver ratings and clinical evaluation tended to be slightly lower than that for patient-based self-assessment. Depression showed a positive correlation with disability and had a nonsystematic influence on UPDRS-section 2 (ADL) scores. As expected, there was a significant correlation between perceived disability and health-related quality of life measures. Caregiver burden did not reduce the level of agreement with neurologists as to the overall rating of any given patient's disability. In PD, UPDRS-section 2-based assessment of disability by patients themselves and caregivers is a valid and reliable outcome.

Background: Over a 10-year period (1984–1996) a child guidance clinic developed a service in the community for parents with young children with mental health problems. This included support for primary care staff and training courses. The clinical input to the young children developed from a clinic within the child guidance clinic (1984–87), to a specialist clinic for under fives (1990–91) to a service run by a nurse in the community (1994–95), with nurses referring to colleagues only the more complicated cases. Method: The work in 1990–91 was compared with the work in 1994–95. The family and clinic scored the outcome of the work, by recording the severity of the problem, separately, on unanchored 5-point Likert scales before and after treatment. For the evaluation in 1994–95 a satisfaction questionnaire was also developed. The cost of running the two different clinics was calculated. Results: The results indicated that there was a slight fall in the effect size for the clinical work in 1994–95, but this method of working was two-thirds of the cost of the previous clinic. The parents were satisfied with both services. The post-contact parental satisfaction questionnaire had face validity, construct validity and internal consistency. Conclusions: Nurses working on their own in the community can be a cost effective method for working with families with young children. Some families will need to be referred on to specialist teams and more work needs to be done to establish which families and when referral is appropriate. The questionnaire was shown to be a valid and reliable way of assessing family satisfaction.

Several studies have assessed the association between air pollution and hospital admissions or emergency room visits for asthma. Because of both the presence of missing data and the small number of observations, the relationship between air pollution and mortality for respiratory causes has been rarely analysed, and when it has, the results are very inconclusive or even inconsistent. The objective of this study is to assess the relation between levels of air pollutants (black smoke, sulphur dioxide, nitrogen dioxide and ozone), meteorological variables (24th average temperature and relative humidity) and daily mortality for asthma (ICD-9 493, 2 to 45 years old) in Barcelona, Spain, during the period 1986}1989. Since the range of daily mortality for asthma (2 to 45 years old) during the period 1986}1989 was 0}1), we have preferred to consider this variable as dichotomous. First, the relationship between air pollutants, meteorological variables and daily mortality (controlled for the occurrence of asthma epidemics) was estimated using logistic regression models. As was expected, the residuals from this regression were autocorrelated, showing a complex moving average (MA) structure. If covariates were not time dependent the so-called generalized linear mixed models, could be applied. In our case the covariates vary. As a consequence the likelihood is numerically intractable because it involves the evaluation of n-fold integral. An alternative method that avoids these numerical problems is the generalized estimating equations method(GEE). It is a multivariate analogue of quasilikelihood estimation. In the absence of a likelihood function the parameters can be estimated by solving a multivariate analogue of the quasi score function. We have modi"ed the GEE method in this paper, allowing for a di!erent structure in the error covariance matrix (MA). Both air pollutants and meteorological variables are related with the occurrence of a death for asthma. In this sense, nitrogen dioxide, NO2 (β=0·037, p

We investigated daily deaths from sudden infant death syndrome (SIDS) in Cook County, Chicago, from 1 January 1986 to 31 December 1990. The daily SIDS rate was 0.54 deaths/day. Mean daily atmospheric pressure ranged from 952 to 1007 mb. We found a weak link with barometric pressure, whereby an increase of 10 mb was associated with an increased risk of 12% [95% CI 0.1%, 24%]. Cross-tabulation revealed that the highest SIDS rates were associated with a drop from high to low pressure. Possible reasons for this are discussed.