Best Evidence For Effectiveness Research Articles

Étude exploratoire de la mise en place de l’Early Start Denver Model en France

BackgroundThe Early Start Denver model is one of the interventions recommended by the French High Authority on Health since 2012 for the very early care of children with Autism Spectrum Disorders. This program, developed in the United States, has shown the best evidence of effectiveness in an intensive form of delivery that is difficult to generalize to other culturally different contexts. Consequently, its implementation in the French health care system has required some adaptations that have not yet been evaluated. After a summary of the method's features and the results of studies of its effectiveness, this first retrospective descriptive observational study aims to characterize the implementation and practice of this intervention in France. In doing so, it also aims to better understand the potential obstacles to the implementation of early intervention and thus propose avenues for improvement. Material and methodA census of French units offering the Denver model was conducted from June to October 2020. A questionnaire sent to the participating units made it possible to explore different dimensions: first, the characteristics of these units, including their composition. Secondly, their integration into the care network and the children's care pathway. Practice and delivery modalities were also assessed. Finally, the objective was to highlight the difficulties that the teams may have faced when implementing the model. The data were collected in Microsoft Excel® software in order to perform a descriptive statistical analysis. ResultsIn total, 92% of the units surveyed participated in the study and returned the questionnaire. Our results highlight a significant heterogeneity in the deployment of the Denver method at the national level and underline the limit of resources available in the territory, particularly in its intensive delivery form. ConclusionFurther research is still needed to study the feasibility and effectiveness of ESDM interventions deployed in the specific context of the French healthcare system. In addition, significant work remains to be done to establish rapid and identifiable pathways for early intervention in young children with ASD.

Debate: Neurodiversity, autism and healthcare.

We are at a time of unparalleled flux in our understanding of what autism is and now to respond to it, including our understanding of the role of clinical services. For any clinician working in the context of child development and child mental health services, the majority experience is probably of overwhelming demand, and then perhaps confusion. Referrals for neurodevelopmental conditions, and particularly autism, have become an increasing proportion of UK CAMHS referrals in recent years-with the consequent lengthening of wait times extending to years, sometimes equivalent to the whole length of a child's life up until that point. Services are struggling to develop response strategies to meet user frustration, a task not helped by the fact that most interventions in current use have no good evidence of effectiveness. Consequently, a plethora of local approaches and initiatives have developed. In this article I address these clinical and related issues. I discuss current different uses of the term autism, the relation to intellectual disability, and introduce a conceptualisation of autism as emergent and transactional, which is consistent with current developmental and intervention science. This could bridge between neurodiversity and clinical perspectives and implies a framing of early intervention support that has strong clinical trials evidence and provides the basis for a rational and pre-emptive evidenced care pathway, which I describe.

EDITORIAL by Dean Alberto B. Roxas

This special issue of the Acta Medica Philippina is dedicated to the 25 years of existence of Clinical Epidemiology in the Philippines. The Rockefeller Foundation in the early 1980’s, issued a call to major medical schools in the world to participate in an initiative which would promote clinical practice based on the best evidence of effectiveness and the efficient use of resources. Thus, the first Clinical Epidemiology Unit (CEU) in the Philippines was established in 1984 at the University of the Philippines College of Medicine (UPCM) under the sponsorship of Dr. Ernesto Domingo, then Chairman of the Department of Medicine UPCM. This issue includes Dr. Domingo’s reflection of the early years of clinical epidemiology and its future directions during his talk at the anniversary conference last July 30, 2009. This issue also pays tribute to the late Dr. Renato Dantes, third Director of the UP-CEU and noted pulmonologist and clinical epidemiologist. His daughter Anna and colleague and friend Dr. Charles Yu reflect on his legacy.One of the milestones of Clinical Epidemiology in the Philippines is the establishment of the Master of Science in Epidemiology – Clinical Epidemiology (MSE-CE) at the UPCEU. Physicians from various specialties and institutions were trained through this program. The UPCEU eventually became the Department of Clinical Epidemiology (DCE) in 1998 under the leadership of Dean Ramon L. Arcadio. Graduates of the MSE-CE became leaders in promoting clinical epidemiology as a discipline in their respective institutions. New CEUs were established in De la Salle Health Sciences campus, University of Santo Tomas and the Cebu Institute of Medicine.For the past 25 years, Clinical Epidemiology has emphasized multi-disciplinary collaboration across various institutions. This form of collaboration is evident in the articles in this issue–clinical economists working with cardiologists and parasitologists in the two cost analysis studies; socialscientists working with clinical epidemiologists to introduce an effective intervention (Zinc in acute diarrhea management) and to develop and validate measurement instrument (Pictorial Pediatric Symptom checklist); and biostatisticians working with various clinical specialties (oncology, radiology, nursing, infectious diseases). Most of the findings in these researches were used for health policy formulation. DCE, in the pursuit of improving its graduate program, also collaborated with the National Teacher Training Center for the Health Professions to evaluate theMSE-CE program.
 I would like to congratulate the Department of Clinical Epidemiology and its partners and join them in celebrating their 25th anniversary. As you reached this milestone, I encourage you to pause, reflect and identify the lessons that will make your Department stronger in the yearsto come.
 ALBERTO B. ROXAS, MDProfessor & DeanUP College of Medicine

Methodological quality of systematic reviews on Chinese herbal medicine: a methodological survey

BackgroundSystematic reviews (SRs) synthesise the best evidence of effectiveness and safety on Chinese herbal medicine (CHM). Decision-making should be supported by the high-quality evidence of prudently conducted SRs, but the trustworthiness of conclusions may be limited by poor methodological rigour.MethodsThis survey aimed to examine the methodological quality of a representative sample of SRs on CHM published during January 2018 to March 2020. We conducted literature search in Cochrane Database of Systematic Reviews, MEDLINE via Ovid, and EMBASE via Ovid. Eligible SRs must be in Chinese or English with at least one meta-analysis on the treatment effect of any CHM documented in the 2015 Chinese Pharmacopoeia. Two reviewers extracted the bibliographical characteristics of SRs and appraised their methodological quality using AMSTAR 2 (Assessing the Methodological Quality of Systematic Reviews 2). The associations between bibliographical characteristics and methodological quality were investigated using Kruskal-Wallis tests and Spearman’s rank correlation coefficients.ResultsWe sampled and appraised one hundred forty-eight SRs. Overall, one (0.7%) was of high methodological quality; zero (0%), four (2.7%), and one-hundred forty-three (96.6%) SRs were of moderate, low, and critically-low quality. Only thirteen SRs (8.8%) provided a pre-defined protocol; none (0%) provided justifications for including particular primary study designs; six (4.1%) conducted a comprehensive literature search; two (1.4%) provided a list of excluded studies; nine (6.1%) undertook meta-analysis with appropriate methods; and seven (4.7%) reported funding sources of included primary studies. Cochrane reviews had higher overall quality than non-Cochrane reviews (P < 0.001). SRs with European funding support were less likely to have critically-low quality when compared with their counterparts (P = 0.020). SRs conducted by more authors (rs = 0.23; P = 0.006) and published in higher impact factor journals (rs = 0.20; P = 0.044) were associated with higher methodological quality.ConclusionsOur results indicated that the methodological quality of SRs on CHM is low. Future authors should enhance the methodological quality through registering a priori protocols, justifying selection of study designs, conducting comprehensive literature search, providing a list of excluded studies with rationales, using appropriate method for meta-analyses, and reporting funding sources among primary studies.

Evaluation of an alcohol policy measure employing a randomised controlled trial design: Why was it possible?

Some of the best evidence of effects of control policies on alcohol availability stems from controlled experimental studies in the Nordic state-owned alcohol monopolies. Publications from these studies do not, however, explain the process leading up to the implementation of changes in policy measures under controlled experimental conditions. In September 2020, the Norwegian state alcohol monopoly started the implementation of extended trading hours, employing a randomised controlled trial design. In this commentary, we give an account of the process leading up to this implementation and how the monopoly considered various pro- and contra-arguments in this regard. This case illustrates that willingness to contribute to strengthened scientific evidence on alcohol control policies can be embedded in the social responsibility of a state alcohol monopoly.

Involvement of informal carers in discharge planning and transition between hospital and community mental health care: A systematic review.

Family members and friends (informal carers) are very important for providing support to people with mental health difficulties. When these carers are included to care planning patients seem to benefit, as they are less likely to relapse. There are three types of interventions including carers in the patients'transition 1) programmes that offer education in hospital; 2) programmes that involve carers in planning the patients discharge; and 3) programmes that involve carers in hospital care, discharge planning and also follow-up in the community. Interventions including carers that take place both in the hospital and the community have the clearest evidence for benefit on relapse reduction. Comprehensive interventions have the best evidence for effectiveness but challenges in their implementation and resourcing should be considered. It might worth trying to identify and test simpler interventions focusing on discharge planning that can be used in busy services and require more limited resources whilst providing opportunities for the participation of carers. INTRODUCTION: Involving informal carers (family and friends of patients) in mental health interventions can lead to positive clinical and psychosocial outcomes such as relapse prevention or treatment adherence. To explore the evidence on the effectiveness of different models that involve carers in the transition between hospital and community mental health care. Five electronic databases (PsycINFO, CINAHL, MEDLINE, Embase and Scopus) and Grey literature (Open Grey and Grey Literature report) were systematically searched. The results were analysed using a narrative synthesis. Fourteen papers were identified. They described twelve interventions that were categorized into three groups: 1) purely educational programmes in preparation of discharge; 2) programmes that involved carers in planning the transition from the mental health inpatient treatment to community mental health services; and 3) programmes that bridged into the aftercare involving carers in community follow-up. The most comprehensive interventions, i.e. those including psychoeducation, care planning and aftercare follow-up were better evaluated and showed a clearer benefit in improving long-term outcomes and, in particular, reduce re-hospitalization. Comprehensive interventions showed the clearest benefit in improving long-term clinical outcomes of patients. Future research should explore implementation, costs and cost-effectiveness, as comprehensive interventions delivered across different settings are likely to require wide-ranging organizational changes and significant resources.

Pharmacological Management of Neuropsychiatric Symptoms of Dementia.

Neuropsychiatric symptoms are universal across all stages and types of dementia and can cause significant challenges for patients and caregivers. While there are currently no approved medications for treatment of neuropsychiatric symptoms of dementia, a variety of psychotropic medications such as antipsychotics, benzodiazepines, anticonvulsants, and antidepressants are used off-label to treat these symptoms. This systematic review evaluated the available evidence for effectiveness and tolerability of pharmacologic treatments in addressing behavioral disturbances in dementia. Inclusion criteria were placebo-controlled, randomized controlled clinical trials (RCTs) or meta-analyses; a total of 38 studies and 3 meta-analyses representing an additional 27 RCTs met the inclusion criteria. Of the medication classes evaluated, atypical antipsychotics had the greatest available evidence for use, however, the treatment effect size was modest. Nine trials of antidepressants were included; 3 trials supported use in dementia. Eight trials of anticonvulsants were included; only one showed benefit. For benzodiazepines, 2 RCTs were included; only one trial of lorazepam showed improvement. Six trials of melatonin agonists were included; none showed efficacy outside of improved sleep measures. Evidence for effectiveness of pimavanserin and dextromethorphan-quinidine was limited to one study each, both of which showed benefit. Despite the widespread off-label use of psychotropic medications for treatment of neuropsychiatric symptoms in dementia, there are relatively few RCTs to evaluate their use with treatment effect sizes absent or modest for most medication classes. Of the medication classes reviewed, atypical antipsychotics have the best evidence for effectiveness, however, the overall magnitude of treatment effect is modest and must be balanced with risk of serious adverse events including death.

Elaboración, aplicación y evaluación de pesticidas orgánicos en jardín ornamental

El presente artículo tuvo como objetivo principal de elaborar, aplicar y evaluar pesticidas orgánicos en el jardín ornamental de la facultad de Ciencias Zootécnicas de la Universidad Técnica de Manabí. Para lo cual se tuvo como muestra poblacional ocho insectos que fueron observados en cuatro mediciones, así como la generación de 12 pesticidas orgánicos que fueron aplicados para el control de los insectos, así como la prevención implícita de plagas, hongos, que podrían estar presentes. En promedio de porcentaje se evidencia que los insecticidas que han presentados mejor evidencia de efectividad se encuentran: Ajo, Cebolla, Helecho, Neem, Tabaco. Lo cual conlleva a deducir sobre las propiedades que presentan en relación a la acción protectora en favorecer la erradicación de insectos en espacios de jardinería ornamental. La investigación permite corroborar que el uso de insecticidas biológicos, pueden ser concomitantes en la erradicación de plagas y de insectos.

Does explicit teaching of critical thinking improve critical thinking skills of English language learners in higher education? A critical review of causal evidence

This paper presents the results of a systematic review of international studies to establish whether explicit teaching of critical thinking is effective in enhancing the critical thinking skills of English language learners in higher education and to identify the most promising approaches. A search of 12 electronic databases supplemented by other sources yielded more than 1794 studies. Only 36 met the pre-defined inclusion and exclusion criteria. A range of approaches were tested and almost all claimed to be effective, but only explicit instruction in general critical thinking skills was found to have the best evidence of effectiveness. However, because most of the studies were small-scale and/or methodologically flawed, the evidence is not strong enough to be conclusive. Evidence for the other approaches was even weaker. These findings suggest that research in this field is still rather immature and more large-scale, replicable robust studies are needed to advance the field.

Evaluation of the “On the level” psychoeducational group programme for Bipolar Affective Disorder in a rural context

Introduction: The delivery of psychoeducational group programmes is a National Institute for Clinical Excellence recommended treatment for Bipolar Affective Disorder for which there is good evidence for effectiveness, acceptability, and cost-effectiveness. “On the level” is a group-CBT based psychoeducational intervention for adults experiencing BPAD developed by the North Lee Adult Mental Health Service. The present study aims to evaluate the “On the level” group as implemented by the North Cork Adult Mental Health Service at Mallow Primary Healthcare Centre. Methods: The study will employ a mixed methods approach with a quantitative and qualitative arm. The quantitative arm will employ a repeated measures design using outcome measures assessing depressive and manic symptomatology at three time points: pre-intervention, post-intervention, and 3-month follow-up. For the qualitative arm, participants will be invited to participate in a focus group which will probe for pertinent issues with regard to access, positive and negative experience of the group, and perceived effectiveness of the group. Results: Scores on outcome measures will be transformed into standard scores and clinically meaningful changed assessed on the basis that a Discussions/conclusions: Results will be discussed in relation to the overall effectiveness of the group and in relation to issues revealed surrounding access, experiences of the group, and perceived usefulness. Lessons learned: This is the first evaluation of “On the Level” which has been implemented in a rural context and so it is anticipated that this study will reveal a number of unique aspects of this context which will inform future offerings. Limitations: The sample size used in the study will be small which will prevent the use of inferential statistics, and the creation of a control group will not be possible. Suggestions for future research: Future studies should be prospective in nature, group allocation should be randomised, and an active control group included.

Identification of factors that support successful implementation of care bundles in the acute medical setting: a qualitative study

BackgroundClinical guidelines offer an accessible synthesis of the best evidence of effectiveness of interventions, providing recommendations and standards for clinical practice. Many guidelines are relevant to the diagnosis and management of the acutely unwell patient during the first 24–48 h of admission. Care bundles are comprised of a small number of evidence-based interventions that when implemented together aim to achieve better outcomes than when implemented individually. Care bundles that are explicitly developed from guidelines to provide a set of related evidence-based actions have been shown to improve the care of many conditions in emergency, acute and critical care settings. This study aimed to review the implementation of two distinct care bundles in the acute medical setting and identify the factors that supported successful implementation.MethodsTwo initiatives that had used a systematic approach to quality improvement to successfully implement care bundles within the acute medical setting were selected as case studies. Contemporaneous data generated during the initiatives included the review reports, review minutes and audio recordings of the review meetings at different time points. Data were subject to deductive analysis using three domains of the Consolidated Framework for Implementation Research to identify factors that were important in the implementation of the care bundles.ResultsSeveral factors were identified that directly influenced the implementation of the care bundles. Firstly, the availability of resources to support initiatives, which included training to develop quality improvement skills within the team and building capacity within the organisation more generally. Secondly, the perceived sustainability of changes by stakeholders influenced the embedding new care processes into existing clinical systems, maximising their chance of being sustained. Thirdly, senior leadership support was seen as critical not just in supporting implementation but also in sustaining longer-term changes brought about by the initiative. Lastly, practitioner incentives were identified as potential levers to engage junior doctors, a crucial part of the acute medical work force and essential to the initiatives, as there is currently little recognition or reward for involvementConclusionsThe factors identified have been shown to be supportive in the successful implementation of care bundles as a mechanism for implementing clinical guidelines. Addressing these factors at a practitioner and organisational level, alongside the use of a systematic quality improvement approach, should increase the likelihood that care bundles will be implemented successfully to deliver evidence based changes in the acute medical setting.

A Systematic Review of School-Based Alcohol and other Drug Prevention Programs.

Background: Alcohol use in adolescents constitutes a major public health concern. Europe is the heaviest drinking region of the world. Several school-based alcohol prevention programs have been developed but it is not clear whether they are really effective. The present study was aimed at identifying the typology with the best evidence of effectiveness in European studies. Methods: A systematic search of meta-analyses and/or randomized controlled trials (RCTs) on interventions school-based prevention programs aimed at preventing alcohol consumption or changing the attitudes to consume alcohol. Results: A meta-analysis published in 2011 and 12 RCTs more recently published were identified. The meta-analysis evaluated 53 RCTs but only 11.3% of them were conducted in Europe. Globally, 23 RCTs (43.4%) showed some evidence of effectiveness, and 30 RCTs (56.6%) did not find significant difference between the groups. According to the conclusions of the meta-analysis, the Unplugged program should be considered as a practice option in Europe. Among the other 12 RCTs, 42% were conducted in Europe. Globally, 7 studies (58.3%) achieved positive results, and 5 studies (41.7%) did not find significant differences or produced a mixed pattern of results. Three of the 5 European trials (60%) used the Unplugged program with positive results. Conclusion: Even if further studies should be conducted to confirm these results, Unplugged appears to be the prevention project with the best evidence of effectiveness in European studies.

Managing caries in primary teeth

N. P. T. Innes and D. J. P. Evans compare the different modern approaches to managing dental caries in primary teeth to those used for the carious permanent dentition. When prevention of dental caries fails, and a child is exposed to the risk of pain and infection, the disease must be managed to reduce this risk. There is growing evidence supporting more ‘biological’ and fewer ‘surgical’ approaches to managing dental caries in primary teeth. These biological methods include partial and stepwise caries removal procedures, as well as techniques where no caries is removed. An overview of clinical trials comparing these biological methods to complete caries removal shows that they perform as well as traditional methods and have the advantage of reducing the incidence of iatrogenic pulpal exposures. The Hall Technique is one biological approach to managing caries in primary molars which involves sealing caries beneath preformed metal (stainless steel) crowns. The crown is cemented over the tooth without caries removal, tooth preparation or use of local anaesthesia. The clinical steps for the Hall Technique are straightforward but, as with all dental care provision, appropriate treatment planning for the procedure requires skill. The Hall Technique offers another method of managing early to moderately advanced, active carious lesions in primary molars, with good evidence of effectiveness and acceptability. This evidence aligns with the positive findings of other studies on biological strategies for managing caries in primary teeth.

Self-management support interventions to reduce health care utilisation without compromising outcomes: a systematic review and meta-analysis.

BackgroundThere is increasing interest in the role of ‘self-management’ interventions to support the management of long-term conditions in health service settings. Self-management may include patient education, support for decision-making, self-monitoring and psychological and social support. Self-management support has potential to improve the efficiency of health services by reducing other forms of utilisation (such as primary care or hospital use), but a shift to self-management may lead to negative outcomes, such as patients who feel more anxious about their health, are less able to cope, or who receive worse quality of care, all of which may impact on their health and quality of life. We sought to determine which models of self-management support are associated with significant reductions in health services utilisation without compromising outcomes among patients with long-term conditions.MethodsWe used systematic review with meta-analysis. We included randomised controlled trials in patients with long-term conditions which included self-management support interventions and reported measures of service utilisation or costs, as well as measures of health outcomes (standardized disease specific quality of life, generic quality of life, or depression/anxiety).We searched multiple databases (CENTRAL, CINAHL, Econlit, EMBASE, HEED, MEDLINE, NHS EED and PsycINFO) and the reference lists of published reviews. We calculated effects sizes for both outcomes and costs, and presented the results in permutation plots, as well as conventional meta-analyses.ResultsWe included 184 studies. Self-management support was associated with small but significant improvements in health outcomes, with the best evidence of effectiveness in patients with diabetic, respiratory, cardiovascular and mental health conditions. Only a minority of self-management support interventions reported reductions in health care utilisation in association with decrements in health. Evidence for reductions in utilisation associated with self-management support was strongest in respiratory and cardiovascular problems. Studies at higher risk of bias were more likely to report benefits.ConclusionsSelf-management support interventions can reduce health service utilization without compromising patient health outcomes, although effects were generally small, and the evidence was strongest in respiratory and cardiovascular disorders. Further work is needed to determine which components of self-management support are most effective.Electronic supplementary materialThe online version of this article (doi:10.1186/1472-6963-14-356) contains supplementary material, which is available to authorized users.

International experience in controlling pharmaceutical expenditure: influencing patients and providers and regulating industry - a systematic review.

ObjectiveTo review international policies to control expenditure on pharmaceuticals by influencing the behaviour of patients and providers and regulating the pharmaceutical industry.MethodSystematic review of experimental and quasi-experimental studies. Published studies were identified with an electronic search strategy using MEDLINE and EMBASE from 1980 to May 2012. Studies were eligible if they assessed the effect of policies aimed at influencing the behaviour of patients and providers, and regulating the pharmaceutical industry. Outcome measures included pharmaceutical expenditure, prices or utilization; other resource use relating to pharmaceuticals; and health outcomes and patients’ or providers’ behaviour relating to pharmaceutical use. Quality assessment criteria for each study design were developed based on the standard criteria recommended by the Cochrane Effective Practice and Organisation of Care (EPOC) group.The review includes studies based on randomized controlled trials and rigorous quasi-experimental designs (interrupted time-series and controlled before-and-after studies). Studies were excluded if they were conducted within a single hospital or practice; related to pharmaceutical care services or disease management; had less than 6 months of follow-up period (or less than 12 months overall for interrupted time series); if data in controlled before-and-after studies were not collected contemporaneously or if no rationale was stated for the choice of control group; or if relevant and interpretable data were not presented.ResultsA total of 255 studies met the inclusion criteria for this review. The majority of the studies relating to patients evaluated cost sharing interventions such as user charges (52 studies). User charges do reduce utilization of pharmaceuticals, and reduce public expenditure by shifting costs to patients. But they reduce the use of essential as well as non-essential drugs, and without adequate exemptions they affect vulnerable groups disproportionately.The majority of studies relating to doctors evaluated the effects of educational approaches (78 studies), reimbursement restrictions (48 studies) and incentive systems (22 studies). Evidence on these policies is of mixed quality. It appears possible to influence prescribing modestly, through various means, but it is essential that messages to prescribers are based on good evidence of effectiveness and cost-effectiveness.Twenty-nine studies related to industry regulation, and they were of mixed quality. Evidence from studies of reference pricing suggests that this may result in cost savings. These are, however, achieved not by companies reducing or restraining prices, or by reductions in the overall volume of prescriptions, but by some shifts in use and shifting costs to patients, with consequent adverse effects on the equity of access to medicines. Other price and profit controls remain almost completely lacking in evaluative evidence.ConclusionsIt may be that the undesirable consequences of policies influencing patients, particularly user charges, can outweigh the benefits. To influence demand for pharmaceuticals, it is more appropriate to influence prescribing doctors and although interventions to improve prescribing practice have been developed, they often achieve relatively modest benefits and sometimes at high cost. Good evaluative evidence related to industry regulation is scarce despite its policy importance.

Routine vaginal examinations for assessing progress of labour to improve outcomes for women and babies at term

Vaginal examinations have become a routine intervention in labour as a means of assessing labour progress. Used at regular intervals, either alone or as a component of the partogram (a pre-printed form providing a pictorial overview of the progress of labour), the aim is to assess if labour is progressing physiologically, and to provide an early warning of slow progress. Abnormally slow progress can be a sign of labour dystocia, which is associated with maternal and fetal morbidity and mortality, particularly in low-income countries where appropriate interventions cannot easily be accessed. However, over-diagnosis of dystocia can lead to iatrogenic morbidity from unnecessary intervention (e.g. operative vaginal birth or caesarean section). It is, therefore, important to establish whether or not the routine use of vaginal examinations is an effective intervention, both as a diagnostic tool for true labour dystocia, and as an accurate measure of physiological labour progress.To compare the effectiveness, acceptability and consequences of digital vaginal examination(s) (alone or within the context of the partogram) with other strategies, or different timings, to assess progress during labour at term.We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (28 February 2013) and reference lists of identified studies.We included randomised controlled trials (RCTs) of vaginal examinations (including digital assessment of the consistency of the cervix, and the degree of dilation and position of the opening of the uterus (cervical os); and position and station of the fetal presenting part, with or without abdominal palpation) compared with other ways of assessing progress of labour. We also included studies assessing different timings of vaginal examinations. We excluded quasi-RCTs and cross-over trials. We also excluded trials with a primary focus on assessing progress of labour using the partogram (of which vaginal examinations is one component) as this is covered by another Cochrane review. However, studies where vaginal examinations were used within the context of the partogram were included if the studies were randomised according to the vaginal examination component.Three review authors assessed the studies for inclusion in the review. Two authors undertook independent data extraction and assessed the risk of bias of each included study. A third review author also checked data extraction and risk of bias. Data entry was checked.We found two studies that met our inclusion criteria but they were of unclear quality. One study, involving 307 women, compared vaginal examinations with rectal examinations, and the other study, involving 150 women, compared two-hourly with four-hourly vaginal examinations. Both studies were of unclear quality in terms of risk of selection bias, and the study comparing the timing of the vaginal examinations excluded 27% (two hourly) to 28% (four hourly) of women after randomisation because they no longer met the inclusion criteria.When comparing routine vaginal examinations with routine rectal examinations to assess the progress of labour, we identified no difference in neonatal infections requiring antibiotics (risk ratio (RR) 0.33, 95% confidence interval (CI) 0.01 to 8.07, one study, 307 infants). There were no data on the other primary outcomes of length of labour, maternal infections requiring antibiotics and women's overall views of labour. The study did show that significantly fewer women reported that vaginal examination was very uncomfortable compared with rectal examinations (RR 0.42, 95% CI 0.25 to 0.70, one study, 303 women). We identified no difference in the secondary outcomes of augmentation, caesarean section, spontaneous vaginal birth, operative vaginal birth, perinatal mortality and admission to neonatal intensive care.Comparing two-hourly vaginal examinations with four-hourly vaginal examinations in labour, we found no difference in length of labour (mean difference in minutes (MD) -6.00, 95% CI -88.70 to 76.70, one study, 109 women). There were no data on the other primary outcomes of maternal or neonatal infections requiring antibiotics, and women's overall views of labour. We identified no difference in the secondary outcomes of augmentation, epidural for pain relief, caesarean section, spontaneous vaginal birth and operative vaginal birth.On the basis of women's preferences, vaginal examination seems to be preferred to rectal examination. For all other outcomes, we found no evidence to support or reject the use of routine vaginal examinations in labour to improve outcomes for women and babies. The two studies included in the review were both small, and carried out in high-income countries in the 1990s. It is surprising that there is such a widespread use of this intervention without good evidence of effectiveness, particularly considering the sensitivity of the procedure for the women receiving it, and the potential for adverse consequences in some settings.The effectiveness of the use and timing of routine vaginal examinations in labour, and other ways of assessing progress in labour, including maternal behavioural cues, should be the focus of new research as a matter of urgency. Women's views of ways of assessing labour progress should be given high priority in any future research in this area.

Modern approaches to caries management of the primary dentition

When prevention of dental caries fails, and a child is exposed to the risk of pain and infection, the disease must be managed to reduce this risk. There is growing evidence supporting more 'biological' and fewer 'surgical' approaches to managing dental caries in primary teeth. These biological methods include partial and stepwise caries removal procedures, as well as techniques where no caries is removed. An overview of clinical trials comparing these biological methods to complete caries removal shows that they perform as well as traditional methods and have the advantage of reducing the incidence of iatrogenic pulpal exposures. The Hall Technique is one biological approach to managing caries in primary molars which involves sealing caries beneath preformed metal (stainless steel) crowns. The crown is cemented over the tooth without caries removal, tooth preparation or use of local anaesthesia. The clinical steps for the Hall Technique are straightforward but, as with all dental care provision, appropriate treatment planning for the procedure requires skill. The Hall Technique offers another method of managing early to moderately advanced, active carious lesions in primary molars, with good evidence of effectiveness and acceptability. This evidence aligns with the positive findings of other studies on biological strategies for managing caries in primary teeth.

Psychological therapies for the treatment of post‐traumatic stress disorder in children and adolescents (Review)

Post-traumatic stress disorder (PTSD) is highly prevalent in children and adolescents who have experienced trauma and has high personal and health costs. Although a wide range of psychological therapies have been used in the treatment of PTSD there are no systematic reviews of these therapies in children and adolescents. To examine the effectiveness of psychological therapies in treating children and adolescents who have been diagnosed with PTSD. We searched the Cochrane Depression, Anxiety and Neurosis Review Group's Specialised Register (CCDANCTR) to December 2011. The CCDANCTR includes relevant randomised controlled trials from the following bibliographic databases: CENTRAL (the Cochrane Central Register of Controlled Trials) (all years), EMBASE (1974 -), MEDLINE (1950 -) and PsycINFO (1967 -). We also checked reference lists of relevant studies and reviews. We applied no date or language restrictions. All randomised controlled trials of psychological therapies compared to a control, pharmacological therapy or other treatments in children or adolescents exposed to a traumatic event or diagnosed with PTSD. Two members of the review group independently extracted data. If differences were identified, they were resolved by consensus, or referral to the review team. We calculated the odds ratio (OR) for binary outcomes, the standardised mean difference (SMD) for continuous outcomes, and 95% confidence intervals (CI) for both, using a fixed-effect model. If heterogeneity was found we used a random-effects model. Fourteen studies including 758 participants were included in this review. The types of trauma participants had been exposed to included sexual abuse, civil violence, natural disaster, domestic violence and motor vehicle accidents. Most participants were clients of a trauma-related support service. The psychological therapies used in these studies were cognitive behavioural therapy (CBT), exposure-based, psychodynamic, narrative, supportive counselling, and eye movement desensitisation and reprocessing (EMDR). Most compared a psychological therapy to a control group. No study compared psychological therapies to pharmacological therapies alone or as an adjunct to a psychological therapy. Across all psychological therapies, improvement was significantly better (three studies, n = 80, OR 4.21, 95% CI 1.12 to 15.85) and symptoms of PTSD (seven studies, n = 271, SMD -0.90, 95% CI -1.24 to -0.42), anxiety (three studies, n = 91, SMD -0.57, 95% CI -1.00 to -0.13) and depression (five studies, n = 156, SMD -0.74, 95% CI -1.11 to -0.36) were significantly lower within a month of completing psychological therapy compared to a control group. The psychological therapy for which there was the best evidence of effectiveness was CBT. Improvement was significantly better for up to a year following treatment (up to one month: two studies, n = 49, OR 8.64, 95% CI 2.01 to 37.14; up to one year: one study, n = 25, OR 8.00, 95% CI 1.21 to 52.69). PTSD symptom scores were also significantly lower for up to one year (up to one month: three studies, n = 98, SMD -1.34, 95% CI -1.79 to -0.89; up to one year: one study, n = 36, SMD -0.73, 95% CI -1.44 to -0.01), and depression scores were lower for up to a month (three studies, n = 98, SMD -0.80, 95% CI -1.47 to -0.13) in the CBT group compared to a control. No adverse effects were identified. No study was rated as a high risk for selection or detection bias but a minority were rated as a high risk for attrition, reporting and other bias. Most included studies were rated as an unclear risk for selection, detection and attrition bias. There is evidence for the effectiveness of psychological therapies, particularly CBT, for treating PTSD in children and adolescents for up to a month following treatment. At this stage, there is no clear evidence for the effectiveness of one psychological therapy compared to others. There is also not enough evidence to conclude that children and adolescents with particular types of trauma are more or less likely to respond to psychological therapies than others. The findings of this review are limited by the potential for methodological biases, and the small number and generally small size of identified studies. In addition, there was evidence of substantial heterogeneity in some analyses which could not be explained by subgroup or sensitivity analyses. More evidence is required for the effectiveness of all psychological therapies more than one month after treatment. Much more evidence is needed to demonstrate the relative effectiveness of different psychological therapies or the effectiveness of psychological therapies compared to other treatments. More details are required in future trials in regards to the types of trauma that preceded the diagnosis of PTSD and whether the traumas are single event or ongoing. Future studies should also aim to identify the most valid and reliable measures of PTSD symptoms and ensure that all scores, total and sub-scores, are consistently reported.

Effects of a Data-Driven District Reform Model on State Assessment Outcomes

A district-level reform model created by the Center for Data-Driven Reform in Education (CDDRE) provided consultation with district leaders on strategic use of data and selection of proven programs. Fifty-nine districts in seven states were randomly assigned to CDDRE or control conditions. A total of 397 elementary and 225 middle schools were followed over a period of up to 4 years. In a district-level hierarchical linear modeling (HLM) analysis controlling for pretests, few important differences on state tests were found 1 and 2 years after CDDRE services began. Positive effects were found on reading outcomes in elementary schools by Year 4. An exploratory analysis found that reading effects were larger for schools that selected reading programs with good evidence of effectiveness than for those that did not.

Pharmacotherapy Options for the Management of Cluster Headache

Cluster headache is a primary headache syndrome characterized by attacks of severe unilateral headache typically lasting 30 to 180 minutes without treatment and prominent autonomic symptoms on the affected side. Often attacks occur in cycles lasting weeks to months with up to 8 attacks per day, and a minority of individuals continue to experience attacks throughout the year. Persons with cluster headache usually require both acute medication for attacks and preventive treatment to keep the headaches from occurring. Subcutaneous sumatriptan is the most effective medication for acute cluster attacks, but other triptans such as zolmitriptan nasal spray are also effective. inhaling 100% oxygen is also effective and is a useful treatment for those with frequent attacks or contraindications to triptans. Corticosteroids are among the most effective transitional treatments, typically used at the start of a cycle. Dihydroergotamine is an effective treatment for refractory or severe cluster headache with multiple attacks requiring large triptan doses. Verapamil and lithium are among the most effective preventive medications with good evidence of effectiveness, but other studies support the use of gabapentin, topiramate, diavalproex sodium, and methysergide, to name a few. Each of these medications requires monitoring for adverse events and can be discontinued within a few weeks of a cluster headache cycle.