Robust Randomized Controlled Trials Research Articles

Systematic review and meta-analysis of randomized controlled trials for the management of limited vertical height in the posterior region: short implants (5 to 8 mm) vs longer implants (> 8 mm) in vertically augmented sites.

The aim of this study was to undertake a systematic review with meta-analysis on randomized controlled trials (RCTs) to compare the rates of survival, success, and complications of short implants to those of longer implants in the posterior regions. Electronic literature searches were conducted through the MEDLINE (PubMed) and EMBASE databases to locate all relevant articles published between January 1, 1990, and April 30, 2013. Eligible studies were selected based on inclusion criteria, and quality assessments were conducted. After data extraction, meta-analyses were performed. In total, 539 dental implants (265 short implants [length 5 to 8 mm] and 274 control implants [length > 8 mm]) from four RCTs were included. The fixed prostheses of multiple short and control implants were all splinted. The mean follow-up period was 2.1 years. The 1-year and 5-year cumulative survival rates (CSR) were 98.7% (95% confidence interval [CI], 97.8% to 99.5%) and 93.6% (95% CI, 89.8% to 97.5%), respectively, for the short implant group and 98.0% (95% CI, 96.9% to 99.1%) and 90.3% (95% CI, 85.2% to 95.4%), respectively, for the control implant group. The CSRs of the two groups did not demonstrate a statistically significant difference. There were also no statistically significant differences in success rates, failure rates, or complications between the two groups. Placement of short dental implants could be a predictable alternative to longer implants to reduce surgical complications and patient morbidity in situations where vertical augmentation procedures are needed. However, only four studies with potential risk of bias were selected in this meta-analysis. Within the limitations of this meta-analysis, these results should be confirmed with robust methodology and RCTs with longer follow-up duration.

Efficacy and experiences of telephone counselling for informal carers of people with dementia.

Informal carers of people with dementia can suffer from depressive symptoms, emotional distress and other physiological, social and financial consequences. This review focuses on three main objectives:To:1) produce a quantitative review of the efficacy of telephone counselling for informal carers of people with dementia;2) synthesize qualitative studies to explore carers' experiences of receiving telephone counselling and counsellors' experiences of conducting telephone counselling; and3) integrate 1) and 2) to identify aspects of the intervention that are valued and work well, and those interventional components that should be improved or redesigned. The Cochrane Dementia and Cognitive Improvement Group's Specialized Register, The Cochrane Library, MEDLINE, MEDLINE in Process, EMBASE, CINAHL, PSYNDEX, PsycINFO, Web of Science, DIMDI databases, Springer database, Science direct and trial registers were searched on 3 May 2011 and updated on 25 February 2013. A Forward Citation search was conducted for included studies in Web of Science and Google Scholar. We used the Related Articles service of PubMed for included studies, contacted experts and hand-searched abstracts of five congresses. Randomised controlled trials (RCTs) or cross-over trials that compared telephone counselling for informal carers of people with dementia against no treatment, usual care or friendly calls for chatting were included evaluation of efficacy. Qualitative studies with qualitative methods of data collection and analysis were also included to address experiences with telephone counselling. Two authors independently screened articles for inclusion criteria, extracted data and assessed the quantitative trials with the Cochrane 'Risk of bias' tool and the qualitative studies with the Critical Appraisal Skills Program (CASP) tool. The authors conducted meta-analyses, but reported some results in narrative form due to clinical heterogeneity. The authors synthesised the qualitative data and integrated quantitative RCT data with the qualitative data. Nine RCTs and two qualitative studies were included. Six studies investigated telephone counselling without additional intervention, one study combined telephone counselling with video sessions, and two studies combined it with video sessions and a workbook. All quantitative studies had a high risk of bias in terms of blinding of participants and outcome assessment. Most studies provided no information about random sequence generation and allocation concealment. The quality of the qualitative studies ('thin descriptions') was assessed as moderate. Meta-analyses indicated a reduction of depressive symptoms for telephone counselling without additional intervention (three trials, 163 participants: standardised mean different (SMD) 0.32, 95% confidence interval (CI) 0.01 to 0.63, P value 0.04; moderate quality evidence). The estimated effects on other outcomes (burden, distress, anxiety, quality of life, self-efficacy, satisfaction and social support) were uncertain and differences could not be excluded (burden: four trials, 165 participants: SMD 0.45, 95% CI -0.01 to 0.90, P value 0.05; moderate quality evidence; support: two trials, 67 participants: SMD 0.25, 95% CI -0.24 to 0.73, P value 0.32; low quality evidence). None of the quantitative studies included reported adverse effects or harm due to telephone counselling. Three analytical themes (barriers and facilitators for successful implementation of telephone counselling, counsellor's emotional attitude and content of telephone counselling) and 16 descriptive themes that present the carers' needs for telephone counselling were identified in the thematic synthesis. Integration of quantitative and qualitative data shows potential for improvement. For example, no RCT reported that the counsellor provided 24-hour availability or that there was debriefing of the counsellor. Also, the qualitative studies covered a limited range of ways of performing telephone counselling. There is evidence that telephone counselling can reduce depressive symptoms for carers of people with dementia and that telephone counselling meets important needs of the carer. This result needs to be confirmed in future studies that evaluate efficacy through robust RCTs and the experience aspect through qualitative studies with rich data.

Photodynamic therapy for central serous chorioretinopathy.

Central serous chorioretinopathy (CSCR) is an idiopathic disorder characterised by detachment of the neurosensory retina due to serous fluid accumulation between the photoreceptor outer segments and the retinal pigment epithelium. There are currently no set guidelines or protocols on its treatment. This study was undertaken to assess the current literature on the the efficacy and safety of photodynamic therapy (PDT) as a treatment option for CSCR. Seven databases (PubMed, CENTRAL, MEDLINE, Web of Science, Embase, Scopus, and The Cochrane Database of Systematic Reviews) were searched without restrictions on time or location. We followed PRISMA guidelines and evaluated quality according to STROBE criteria. In total, 117 citations were identified and 31 studies describing 787 eyes were included for review. Data on indications for PDT in CSCR, dosing regimens of verteprofin PDT (which includes treatment dose of vertoporfin, treatment time, fluence, and spot size), number of treatment sessions, response to treatment, mean length of follow-up, and complications were extracted and analysed. Since the introduction of PDT for the treatment of CSCR in 2003, there have been three randomised controlled trials (RCTs), one for acute and two chronic CSCR and 28 further studies that met the STROBE criteria that compared the use of PDT with other treatment options. All studies showed short-term efficacy of PDT in CSCR. The studies were of small sample size and lacked sufficient follow-up to draw conclusions on long-term efficacy and safety. There is sufficient scientific evidence to suggest that PDT may be a useful treatment option for chronic CSCR in the short-term. The review identifies a need for robust RCTs with longer follow-up to ascertain the role of PDT as a useful treatment option for CSCR.

Catgut implantation at acupoints for allergic rhinitis: a systematic review.

To assess the effectiveness and the possible adverse effects of catgut implantation at acupoints for allergic rhinitis (AR). This systematic review was carried out in accordance with the Cochrane Handbook version 5.1.0 and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Extensive literature searches were conducted in PubMed, Excerpta Medical Databases, the Cochrane Library, the China National Infrastructure, Wanfang Chinese Digital Periodical and Conference Database, and the Weipu Chinese Science and Technique Journals Database. The Chinese Clinical Trial Registry Center was also searched for ongoing trials up to September 2012. Randomized controlled trials (RCTs) or quasi-RCTs were included. Risk of bias assessment was performed using the Cochrane tool for assessing risk of bias. Five RCTs with 285 participants were found from 49 relevant studies, but there was just one RCT which met the inclusion criteria for this review. The study showed that treatment of catgut implantation at acupoints could lead to a better alleviation of the signs and symptoms of AR than the crude herb moxibustion. No adverse events were reported in this study. Because of the methodological shortcoming and the risk of bias of the included trial, catgut implantation was proved with only limited evidence for the treatment of AR. Robust RCTs with high quality and larger sample size in this field are hoped to be carried out in the future.

Genitourinary pathogens and preterm birth

The aim is to describe and quantify the association between genitourinary tract infections and preterm birth. Recent studies confirm the importance of identifying and treating both asymptomatic and symptomatic bacteriuria in pregnancy, which is reflected in current antenatal screening guidelines. These guidelines do not recommend routine screening for other asymptomatic lower genital infections (bacterial vaginosis, trichomonas and gonorrhoea) reflecting inconsistent study results, which may reflect differences in study design, size, diagnostics and the timing of screening in pregnancy. Screening for group B Streptococcus (GBS) late in pregnancy is recognized to reduce neonatal disease, but there is a striking lack of robust studies, specifically randomized controlled trials (RCTs), considering the effect of GBS screening earlier in pregnancy on adverse pregnancy outcomes. The potential for screening and treatment of genitourinary tract infections in pregnancy to reduce preterm birth rates has been demonstrated in some RCTs. Current guidelines do not reflect these data because of inconsistencies across the body of evidence. There is a need for robust RCTs to confirm or refute earlier data, to inform the optimal timing for screening in pregnancy and to better quantify the contribution of individual infections to the burden of preterm birth.

Exercise training in breast cancer survivors: a review of trials examining anthropometric and obesity-related biomarkers of breast cancer risk

Background: Substantial observational evidence exists which supports a role for physical activity in improving breast cancer prognosis. Biological pathways linking physical activity to prognosis include alterations in obesity-related biomarkers involving chronic low-grade inflammation, adipokines, and markers of insulin resistance. Exercise interventions, with these biomarkers as end-points, may be beneficial for improving breast cancer outcomes.Objective: To conduct a systematic literature review, investigating the effect of exercise interventions on anthropometric variables and related biomarkers of cancer risk in breast cancer survivors.Methods: The preferred reporting for systematic review and meta-analysis (PRISMA) guidelines were followed. A comprehensive literatures search was conducted using the databases PubMed, Embase, SciVerse, the Cochrane Library, AMED, and PEDro, for articles published in English up to June 2012. Exercise interventions, both randomized and non-randomized, examining a range of biomarkers of cancer risk were included.Results: Thirteen articles, representing nine exercise interventions were included — seven randomized controlled trials (RCT) and two non-randomized trials. A number of trials reported improvements in anthropometrics (percentage body fat, body mass index, and waist / hip circumference). Three trials reported changes in insulin-like growth factor (IGF)-I and IGF-II, and insulin-like growth factor binding protein (IGFBP)-3. There were no reported changes in insulin, glucose, insulin resistance, adipokines or inflammatory markers.Conclusions: More robust RCTs are required to fully elucidate the effect of exercise training on biomarkers of breast cancer risk and determine the role of physical activity as an adjunct to breast cancer treatment as a means of reducing breast cancer recurrence and improving mortality.

Examination of Data, Analytical Issues and Proposed Methods for Conducting Comparative Effectiveness Research Using "Real-World Data"

Examination of Data, Analytical Issues and Proposed Methods for Conducting Comparative Effectiveness Research Using "Real-World Data"

Labor Admission Test

ABSTRACT Labor admission test (LAT) is performed at the onset of labor to establish fetal well-being in low-risk pregnancies and identify those fetuses who either may be hypoxic, needing delivery or at risk of developing hypoxia during labor so that additional measures of fetal surveillance can be instituted to prevent adverse outcomes. We searched the literature in Medline, Cochrane Library and PubMed using the words— cardiotocograph, cardiotocogram, nonstress test, vibroacoustic stimulus (VAS), amniotic fluid index (AFI), Doppler, labor admission test, labor admission cardiotocography (CTG) and reviewed four randomized controlled trials (RCTs) and three systematic reviews to summarize the current evidence regarding use of LAT. Although the existing RCTs and systematic reviews do not favor admission testing, we have critically reviewed the methodology used in some of these major studies. There is a need for robust RCTs with adequate sample size to evaluate the effectiveness of LAT. In clinical practice, while a normal admission CTG reassures the mother and the clinician about the health of the baby, an admission CTG with nonreassuring FHR pattern leads to careful review which may reveal a growth restricted or compromised fetus before onset of active labor when the risk of fetal hypoxia is higher with increasing frequency and duration of uterine contractions. Like in other obstetric interventions, the woman should be offered the choice of LAT after providing appropriate information and her informed decision should be respected.

Target of rapamycin inhibitors (TOR-I; sirolimus and everolimus) for primary immunosuppression in kidney transplant recipients

Target of rapamycin inhibitors (TOR-I) (sirolimus, everolimus) are immunosuppressive agents with a novel mode of action but an uncertain clinical role. To investigate the benefits and harms of immunosuppressive regimens containing TOR-I when compared to other regimens as initial therapy for kidney transplant recipients. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (in The Cochrane Library, issue 2, 2005), MEDLINE (1966-June 2005), EMBASE (1980-June 2005), the specialised register of the Cochrane Renal Group (June 2005)., and contacted authors and pharmaceutical companies to identify relevant studies. All randomised controlled trials (RCTs) and quasi-RCTs where drug regimens containing TOR-I were compared to alternative drug regimens in the immediate post-transplant period were included, without age restriction, dosage or language of report. Two reviewers independently assessed trials for eligibility and quality, and extracted data. Results are expressed as relative risk (RR) or weight mean difference (MD) with 95% confidence intervals (CI). Thirty three trials (142 reports) were included (sirolimus (27), everolimus (5), head-to-head (1)). When TOR-I replaced CNI there was no difference in acute rejection, but serum creatinine was lower (MD -18.31 micromol/L, -30.96 to -5.67), and bone marrow more suppressed (leucopenia: RR 2.02 1.12 to 3.66; thrombocytopenia: RR 6.97 2.97 to 16.36; anaemia: RR 1.67, 1.27 to 2.20). When TOR-I replaced antimetabolites, acute rejection (RR 0.84, 0.71 to 0.99) and cytomegalovirus infection (CMV) (RR 0.49; 0.37 to 0.65) were reduced, but hypercholesterolaemia was increased (RR 1.65, 1.32 to 2.06). For low versus high-dose TOR-I, with equal CNI dose, rejection was increased (RR 1.23, 1.06 to 1.43) but calculated GFR higher (MD 4.27 mL/min, 1.12 to 7.41), and for low-dose TOR-I/standard-dose CNI versus higher-dose TOR-I/reduced CNI, acute rejection (RR 0.67, 0.52 to 0.88) and calculated GFR (MD -9.46 mL/min, -12.16 to -6.76) were reduced. There was no significant difference in mortality, graft loss or malignancy risk for TOR-I in any comparison. TOR-I have been evaluated in four different primary immunosuppressive algorithms; as replacement for CNI and for antimetabolites, in combination with CNI at low and high dose and with variable dose of CNI. Generally, surrogate endpoints for graft survival favour TOR-I (lower risk of acute rejection and higher GFR) and surrogate endpoints for patient outcomes are worsened by TOR-I (bone marrow suppression, lipid disturbance). Long-term hard-endpoint data from methodologically robust RCTs are still needed.

Enteral nutritional support in prevention and treatment of pressure ulcers: A systematic review and meta-analysis

Background: There have been few systematic reviews and no meta-analyses of the clinical benefits of nutritional support in patients with, or at risk of developing, pressure ulcers. Therefore, this systematic review and meta-analysis was undertaken to address the impact of enteral nutritional support on pressure ulcer incidence and healing and a range of other clinically relevant outcome measures in this group. Methods: Fifteen studies (including eight randomised controlled trials (RCTs)) of oral nutritional supplements (ONS) or enteral tube feeding (ETF), identified using electronic databases (including Pub Med and Cochrane) and bibliography searches, were included in the systematic review. Outcomes including pressure ulcer incidence, pressure ulcer healing, quality of life, complications, mortality, anthropometry and dietary intake were recorded, with the aim of comparing nutritional support versus routine care (e.g. usual diet and pressure ulcer care) and nutritional formulas of different composition. Of these 15 studies, 5 RCTs comparing ONS (4 RCTs) and ETF (1 RCT) with routine care could be included in a meta-analysis of pressure ulcer incidence. Results: Meta-analysis showed that ONS (250–500 kcal, 2–26 weeks) were associated with a significantly lower incidence of pressure ulcer development in at-risk patients compared to routine care (odds ratio 0.75, 95% CI 0.62–0.89, 4 RCTs, n = 1224, elderly, post-surgical, chronically hospitalised patients). Similar results were obtained when a combined meta-analysis of ONS (4 RCT) and ETF (1 RCT) trials was performed (OR 0.74, 95% CI 0.62–0.88, 5 RCTs, n = 1325). Individual studies showed a trend towards improved healing of existing pressure ulcers with disease-specific (including high protein) versus standard formulas, although robust RCTs are required to confirm this. Although some studies indicate that total nutritional intake is improved, data on other outcome measures (quality of life) are lacking. Conclusions: This systematic review shows enteral nutritional support, particularly high protein ONS, can significantly reduce the risk of developing pressure ulcers (by 25%). Although studies suggest ONS and ETF may improve healing of PU, further research to confirm this trend is required.