Computer-assisted versus oral-and-written dietary history taking for diabetes mellitus

Background: Diabetes is a chronic illness characterised by insulin resistance or deficiency, resulting in elevated glycosylated haemoglobin A1c (HbA1c) levels. Diet and adherence to dietary advice is associated with lower HbA1c levels and control of disease. Dietary history may be an effective clinical tool for diabetes management and has traditionally been taken by oral-and-written methods, although it can also be collected using computer-assisted history taking systems (CAHTS). Although CAHTS were first described in the 1960s, there remains uncertainty about the impact of these methods on dietary history collection, clinical care and patient outcomes such as quality of life. Objectives: To assess the effects of computer-assisted versus oral-and-written dietary history taking on patient outcomes for diabetes mellitus. Search methods: We searched The Cochrane Library (issue 6, 2011), MEDLINE (January 1985 to June 2011), EMBASE (January 1980 to June 2011) and CINAHL (January 1981 to June 2011). Reference lists of obtained articles were also pursued further and no limits were imposed on languages and publication status. Selection criteria: Randomised controlled trials of computer-assisted versus oral-and-written history taking in patients with diabetes mellitus. Data collection and analysis: Two authors independently scanned the title and abstract of retrieved articles. Potentially relevant articles were investigated as full text. Studies that met the inclusion criteria were abstracted for relevant population and intervention characteristics with any disagreements resolved by discussion, or by a third party. Risk of bias was similarly assessed independently. Main results: Of the 2991 studies retrieved, only one study with 38 study participants compared the two methods of history taking over a total of eight weeks. The authors found that as patients became increasingly familiar with using CAHTS, the correlation between patients' food records and computer assessments improved. Reported fat intake decreased in the control group and increased when queried by the computer. The effect of the intervention on the management of diabetes mellitus and blood glucose levels was not reported. Risk of bias was considered moderate for this study. Authors' conclusions: Based on one small study judged to be of moderate risk of bias, we tentatively conclude that CAHTS may be well received by study participants and potentially offer time saving in practice. However, more robust studies with larger sample sizes are needed to confirm these. We cannot draw on any conclusions in relation to any other clinical outcomes at this stage

The Master Observational Trial: A New Class of Master Protocol to Advance Precision Medicine.

This commentary introduces a new clinical trial construct, the Master Observational Trial (MOT), which hybridizes the power of molecularly based master interventional protocols with the breadth of real-world data. The MOT provides a clinical venue to allow molecular medicine to rapidly advance, answers questions that traditional interventional trials generally do not address, and seamlessly integrates with interventional trials in both diagnostic and therapeutic arenas. The result is a more comprehensive data collection ecosystem in precision medicine

Spinal manipulation or mobilization for lumbar disc herniation with radiculopathy : a protocol for a systematic review and meta-analysis

Introduction: The purpose of this study is to conduct a systematic review and meta-analysis into the effects of spinal manipulation or mobilization for Lumbar Disc Herniation with Radiculopathy (LDHR). Methods: An electronic database search of titles and abstracts of articles published in English will be conducted in the following databases: PEDro (Physiotherapy Evidence Database), CINAHL (Cumulative Index to Nursing and Allied Health Literature), PubMed, Science Direct, Google Scholar, and The Cochrane Library. The specific search strategies will be dependent on the particular database being searched and hand searches of the reference lists of the included articles will also be performed. Studies will be included if they reported an acceptable comparison group, and also reported at least one of the main clinically relevant outcome measures for LDHR. Two independent reviewers will screen the identified records, and all disagreements will be resolved. The internal and external validities of the included studies will be assessed using the PEDro scale and the External Validity Assessment Tool (EVAT) respectively. The clinical relevance and risk of bias of the studies will be determined using the 5-Criteria developed by the Cochrane Back Review Group and the Cochrane Risk of Bias Assessment Tool respectively. Studies will be pooled into meta-analysis where appropriate using RevMan software and the outcomes will be reported using the PRISMA guidelines. Discussion: This review will summarize the current evidence about the effects of spinal manipulation or mobilization compared with other interventions in the management of individuals with Lumbar Disc Herniation with Radiculopathy (LDHR). A meta-analysis will also be conducted where appropriate in this review to compare the effects of spinal manipulation or mobilization with other interventions with a view to finding out which technique is better in the management of individuals with LDHR. Review Registration: This review has been registered with the International Prospective Register of Systematic Reviews (PROSPERO; registration number: CRD42019131292). Keywords: Spinal manipulation; spinal mobilization; lumbar disc herniation; systematic review; meta-analysi

The effectiveness of Atraumatic Restorative Treatment versus conventional restorative treatment for permanent molars and premolars A critical assessment of existing systematic reviews and report of a new systematic review

Available for download at: http://mahara.qmul.ac.uk/view/view.php?id=16447Available for download at: http://mahara.qmul.ac.uk/view/view.php?id=16447Available for download at: http://mahara.qmul.ac.uk/view/view.php?id=16447Available for download at: http://mahara.qmul.ac.uk/view/view.php?id=16447Available for download at: http://mahara.qmul.ac.uk/view/view.php?id=16447Available for download at: http://mahara.qmul.ac.uk/view/view.php?id=16447Available for download at: http://mahara.qmul.ac.uk/view/view.php?id=16447Background: Atraumatic Restorative Treatment (ART) is the removal of caries using hand instruments and restoration of the resulting cavity using an adhesive restorative material. It was designed to restore teeth in communities without access to conventional dental clinics in poorer countries but has come to be used by dentists in the developed world too, as an alternative to conventional restorative treatment. Objectives: 1) to assess the scope and the methodological and reporting quality of existing systematic reviews of the effectiveness of ART compared to conventional restorative treatment; 2) to evaluate the effectiveness of ART compared to conventional treatment in permanent teeth with class I and II cavities. Methods: Searches: 1) for the assessment of existing systematic reviews: Electronic searches were conducted of OVID Medline, OVID Embase, The Cochrane Database of Systematic Reviews (CDSR), the Centre for Reviews and Dissemination (CRD) databases (DARE, NHSEED and HTA), Google Scholar, and the CNKI and CAOD Chinese databases; 2) for the systematic reviews of ART in permanent teeth: the above searches were supplemented by searches of the Cochrane Central Register of Controlled Trials (CENTRAL), LILAC, BBO, IMEAR (WHO Index Medicus for South East Region), WPRIM (WHO Western Pacific Region Index Medicus) and IndMed, Current Controlled Trials, Clinical Trials, OpenSIGLE, IADR conference abstracts and NLM Gateway. Hand searches were conducted of six dental journals known to have reported ART studies. References from retrieved systematic reviews, trials and other related papers were searched for additional reports. Authors were contacted. There were no language restrictions. Selection criteria: 1) for the assessment of existing systematic reviews: systematic reviews that compared ART to conventional treatment for the restoration of dental cavities; 2) for the systematic reviews of ART in permanent teeth: randomised controlled trials that compared ART using any adhesive material to conventional treatment using amalgam or any adhesive material Data collection: 1) for the assessment of existing systematic reviews: Reviews were selected and data was extracted by a single reviewer using a custom made data extraction sheet. Scope was assessed in terms of materials used, teeth and cavity type. Methodological quality was assessed using AMSTAR. Reporting quality was assessed using the PRISMA guidelines; 2) for the systematic reviews of ART in permanent teeth: reports of trials were screened and selected independently by two reviewers and data would have been extracted on a custom made data extraction sheet had there been eligible trials. Results: 1) for the assessment of existing systematic reviews: three systematic reviews were identified. Two of these were restricted to comparing ART with glass-ionomer to conventional treatment with amalgam; two allowed for inclusion of all cavity types in both deciduous and permanent teeth. None was of high methodological quality and reporting quality was good in one of the reviews only; 2) for the systematic reviews of ART in permanent teeth: no eligible trials were identified. Author’s conclusions: 1) existing systematic reviews do not have sufficient scope to allow for the inclusion of potentially eligible trials that would assess ARTs effectiveness and they have been of high to medium risk of bias; 2) it is disappointing that there are no properly conducted randomised controlled trials comparing ART to conventional treatment in class I and II cavities in the permanent dentition

Email for communicating results of diagnostic medical investigations to patients

<p>Background: As medical care becomes more complex and the ability to test for conditions grows, pressure on healthcare providers to convey increasing volumes of test results to patients is driving investigation of alternative technological solutions for their delivery. This review addresses the use of email for communicating results of diagnostic medical investigations to patients.</p> <p>Objectives: To assess the effects of using email for communicating results of diagnostic medical investigations to patients, compared to SMS/ text messaging, telephone communication or usual care, on outcomes, including harms, for health professionals, patients and caregivers, and health services.</p> <p>Search methods: We searched: the Cochrane Consumers and Communication Review Group Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 1 2010), MEDLINE (OvidSP) (1950 to January 2010), EMBASE (OvidSP) (1980 to January 2010), PsycINFO (OvidSP) (1967 to January 2010), CINAHL (EbscoHOST) (1982 to February 2010), and ERIC (CSA) (1965 to January 2010). We searched grey literature: theses/dissertation repositories, trials registers and Google Scholar (searched July 2010). We used additional search methods: examining reference lists and contacting authors.</p> <p>Selection criteria: Randomised controlled trials, quasi-randomised trials, controlled before and after studies and interrupted time series studies of interventions using email for communicating results of any diagnostic medical investigations to patients, and taking the form of 1) unsecured email 2) secure email or 3) web messaging. All healthcare professionals, patients and caregivers in all settings were considered.</p> <p>Data collection and analysis: Two review authors independently assessed the titles and abstracts of retrieved citations. No studies were identified for inclusion. Consequently, no data collection or analysis was possible.</p> <p>Main results: No studies met the inclusion criteria, therefore there are no results to report on the use of email for communicating results of diagnostic medical investigations to patients.</p> <p>Authors' conclusions: In the absence of included studies, we can draw no conclusions on the effects of using email for communicating results of diagnostic medical investigations to patients, and thus no recommendations for practice can be stipulated. Further well-designed research should be conducted to inform practice and policy for communicating patient results via email, as this is a developing area.</p&gt

Selective serotonin reuptake inhibitors (SSRIs) for stroke recovery.

BACKGROUND: Stroke is the major cause of adult disability. Selective serotonin reuptake inhibitors (SSRIs) have been used for many years to manage depression. Recently, small trials have demonstrated that SSRIs might improve recovery after stroke, even in people who are not depressed. Systematic reviews and meta-analyses are the least biased way to bring together data from several trials. Given the promising effect of SSRIs on stroke recovery seen in small trials, a systematic review and meta-analysis is needed. OBJECTIVES: To determine whether SSRIs improve recovery after stroke, and whether treatment with SSRIs was associated with adverse effects. SEARCH METHODS: We searched the Cochrane Stroke Group Trials Register (August 2011), Cochrane Depression Anxiety and Neurosis Group Trials Register (November 2011), Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 8), MEDLINE (from 1948 to August 2011), EMBASE (from 1980 to August 2011), CINAHL (from 1982 to August 2011), AMED (Allied and Complementary Medicine) (from 1985 to August 2011), PsycINFO (from 1967 to August 2011) and PsycBITE (Pyschological Database for Brain Impairment Treatment Efficacy) (March 2012). To identify further published, unpublished and ongoing trials we searched trials registers, pharmaceutical websites, reference lists, contacted experts and performed citation tracking of included studies. SELECTION CRITERIA: We included randomised controlled trials that recruited stroke survivors (ischaemic or haemorrhagic) at any time within the first year. The intervention was any SSRI, given at any dose, for any period. We excluded drugs with mixed pharmacological effects. The comparator was usual care or placebo. In order to be included, trials had to collect data on at least one of our primary (dependence and disability) or secondary (impairments, depression, anxiety, quality of life, fatigue, healthcare cost, death, adverse events and leaving the trial early) outcomes. DATA COLLECTION AND ANALYSIS: We extracted data on demographics, type of stroke, time since stroke, our primary and secondary outcomes, and sources of bias. For trials in English, two review authors independently extracted data. For Chinese papers, one review author extracted data. We used standardised mean differences (SMD) to estimate treatment effects for continuous variables, and risk ratios (RR) for dichotomous effects, with their 95% confidence intervals (CIs). MAIN RESULTS: We identified 56 completed trials of SSRI versus control, of which 52 trials (4059 participants) provided data for meta-analysis. There were statistically significant benefits of SSRI on both of the primary outcomes: RR for reducing dependency at the end of treatment was 0.81 (95% CI 0.68 to 0.97) based on one trial, and for disability score, the SMD was 0.91 (95% CI 0.60 to 1.22) (22 trials involving 1343 participants) with high heterogeneity between trials (I(2) = 87%; P < 0.0001). For neurological deficit, depression and anxiety, there were statistically significant benefits of SSRIs. For neurological deficit score, the SMD was -1.00 (95% CI -1.26 to -0.75) (29 trials involving 2011 participants) with high heterogeneity between trials (I(2) = 86%; P < 0.00001). For dichotomous depression scores, the RR was 0.43 (95% CI 0.24 to 0.77) (eight trials involving 771 participants) with high heterogeneity between trials (I(2) = 77%; P < 0.0001). For continuous depression scores, the SMD was -1.91 (95% CI -2.34 to -1.48) (39 trials involving 2728 participants) with high heterogeneity between trials (I(2) = 95%; P < 0.00001). For anxiety, the SMD was -0.77 (95% CI -1.52 to -0.02) (eight trials involving 413 participants) with high heterogeneity between trials (I(2) = 92%; P < 0.00001). There was no statistically significant benefit of SSRI on cognition, death, motor deficits and leaving the trial early. For cognition, the SMD was 0.32 (95% CI -0.23 to 0.86), (seven trials involving 425 participants) with high heterogeneity between trials (I(2) = 86%; P < 0.00001). The RR for death was 0.76 (95% CI 0.34 to 1.70) (46 trials involving 3344 participants) with no heterogeneity between trials (I(2) = 0%; P = 0.85). For motor deficits, the SMD was -0.33 (95% CI -1.22 to 0.56) (two trials involving 145 participants). The RR for leaving the trial early was 1.02 (95% CI 0.86 to 1.21) in favour of control, with no heterogeneity between trials. There was a non-significant excess of seizures (RR 2.67; 95% CI 0.61 to 11.63) (seven trials involving 444 participants), a non-significant excess of gastrointestinal side effects (RR 1.90; 95% CI 0.94 to 3.85) (14 trials involving 902 participants) and a non-significant excess of bleeding (RR 1.63; 95% CI 0.20 to 13.05) (two trials involving 249 participants) in those allocated SSRIs. Data were not available on quality of life, fatigue or healthcare costs.There was no clear evidence from subgroup analyses that one SSRI was consistently superior to another, or that time since stroke or depression at baseline had a major influence on effect sizes. Sensitivity analyses suggested that effect sizes were smaller when we excluded trials at high or unclear risk of bias.Only eight trials provided data on outcomes after treatment had been completed; the effect sizes were generally in favour of SSRIs but CIs were wide. AUTHORS' CONCLUSIONS: SSRIs appeared to improve dependence, disability, neurological impairment, anxiety and depression after stroke, but there was heterogeneity between trials and methodological limitations in a substantial proportion of the trials. Large, well-designed trials are now needed to determine whether SSRIs should be given routinely to patients with stroke

Reporting ethics committee approval and patient consent by study design in five general medical journals.

BACKGROUND: Authors are required to describe in their manuscripts ethical approval from an appropriate committee and how consent was obtained from participants when research involves human participants. OBJECTIVE: To assess the reporting of these protections for several study designs in general medical journals. DESIGN: A consecutive series of research papers published in the Annals of Internal Medicine, BMJ, JAMA, Lancet and The New England Journal of Medicine between February and May 2003 were reviewed for the reporting of ethical approval and patient consent. Ethical approval, name of approving committee, type of consent, data source and whether the study used data collected as part of a study reported elsewhere were recorded. Differences in failure to report approval and consent by study design, journal and vulnerable study population were evaluated using multivariable logistic regression. RESULTS: Ethical approval and consent were not mentioned in 31% and 47% of manuscripts, respectively. 88 (27%) papers failed to report both approval and consent. Failure to mention ethical approval or consent was significantly more likely in all study designs (except case-control and qualitative studies) than in randomised controlled trials (RCTs). Failure to mention approval was most common in the BMJ and was significantly more likely than in The New England Journal of Medicine. Failure to mention consent was most common in the BMJ and was significantly more likely than in all other journals. No significant differences in approval or consent were found when comparing studies of vulnerable and non-vulnerable participants. CONCLUSION: The reporting of ethical approval and consent in RCTs has improved, but journals are less good at reporting this information for other study designs. Journals should publish this information for all research on human participants

A meta-analysis of transdiagnostic cognitive behavioural therapy in the treatment of child and young person anxiety disorders

Background: Previous meta-analyses of cognitive-behavioural therapy (CBT) for children and young people with anxiety disorders have not considered the efficacy of transdiagnostic CBT for the remission of childhood anxiety. Aim: To provide a meta-analysis on the efficacy of transdiagnostic CBT for children and young people with anxiety disorders. Methods: The analysis included randomized controlled trials using transdiagnostic CBT for children and young people formally diagnosed with an anxiety disorder. An electronic search was conducted using the following databases: ASSIA, Cochrane Controlled Trials Register, Current Controlled Trials, Medline, PsycArticles, PsychInfo, and Web of Knowledge. The search terms included “anxiety disorder(s)”, “anxi∗”, “cognitive behavio∗, “CBT”, “child∗”, “children”, “paediatric”, “adolescent(s)”, “adolescence”, “youth” and “young pe∗”. The studies identified from this search were screened against the inclusion and exclusion criteria, and 20 studies were identified as appropriate for inclusion in the current meta-analysis. Pre- and posttreatment (or control period) data were used for analysis. Results: Findings indicated significantly greater odds of anxiety remission from pre- to posttreatment for those engaged in the transdiagnostic CBT intervention compared with those in the control group, with children in the treatment condition 9.15 times more likely to recover from their anxiety diagnosis than children in the control group. Risk of bias was not correlated with study effect sizes. Conclusions: Transdiagnostic CBT seems effective in reducing symptoms of anxiety in children and young people. Further research is required to investigate the efficacy of CBT for children under the age of 6