Review Of Observational Studies Research Articles

Are the safety profiles of antipsychotic drugs used in dementia the same? An updated review of observational studies.

With an increase in the global prevalence of dementia, there is also an increase in behavioural and psychological symptoms of dementia (BPSD) for which antipsychotic drugs are often used. Despite several safety warnings on antipsychotic use in dementia, there is little evidence to support the efficacy of antipsychotics in individual BPSD symptoms or to evaluate the drug safety profile by individual antipsychotic drug. There is emerging but scarce evidence that suggests an inter-drug variability between antipsychotic safety outcomes in BPSD. The objective of this review was to examine the existing literature on antipsychotic drug use in dementia patients; in particular to see whether inter-drug differences regarding antipsychotic safety were reported. A literature search was conducted for observational studies published in the English language from 2004 to 2014 that reported the risk of all-cause mortality, cerebrovascular events, pneumonia and other outcomes such as hip/femur fracture, deep vein thrombosis (DVT) and hyperglycaemia. Six of 16 mortality studies (38%), 7 of 28 stroke studies (25%), 1 of 6 pneumonia (17%) studies and 2 of 6 fracture studies (33%) investigated inter-drug safety outcomes in elderly patients/dementia patients, while to our knowledge, there are no studies investigating the inter-drug variation of deep-vein thrombosis and hyperglycaemia risk. The results of the observational studies provide mixed results on the safety of antipsychotics in BPSD but it is clear that there are differences between the safety profiles of antipsychotic drugs. Robust evidence of such inter-drug variability could significantly improve patient safety as antipsychotics become more targeted to clinical risk factors.

Treatment of atherosclerotic renovascular hypertension: review of observational studies and a meta-analysis of randomized clinical trials.

Atherosclerotic renal artery stenosis can cause ischaemic nephropathy and arterial hypertension. We herein review the observational and randomized clinical trials (RCTs) comparing medical and endovascular treatment for control of hypertension and renal function preservation. Using the Population Intervention Comparison Outcome (PICO) strategy, we identified the relevant studies and performed a novel meta-analysis of all RCTs to determine the efficacy and safety of endovascular treatment when compared with medical therapy. The following outcomes were examined: baseline follow-up difference in mean systolic and diastolic blood pressure (BP), serum creatinine, number of drugs at follow-up, incident events (heart failure, stroke, and worsening renal function), mortality, cumulative relative risk of heart failure, stroke, and worsening renal function. Seven studies comprising a total of 2155 patients (1741 available at follow-up) were considered, including the recently reported CORAL Study. Compared with baseline, diastolic BP fell more at follow-up in patients in the endovascular than in the medical treatment arm (standard difference in means -0.21, 95% confidence interval (CI): -0.342 to -0.078, P = 0.002) despite a greater reduction in the mean number of antihypertensive drugs (standard difference in means -0.201, 95% CI: -0.302 to -0.1, P < 0.001). At variance, follow-up changes (from baseline) of systolic BP, serum creatinine, and incident cardiovascular event rates did not differ between treatment arms. Thus, patients with atherosclerotic renal artery stenosis receiving endovascular treatment required less anti-antihypertensive drugs at follow-up than those medically treated. Notwithstanding this, they evidenced a better control of diastolic BP.

Abstract P227: Diabetes Mellitus and Venous Thromboembolism: A Systematic Review and Meta-analysis

Introduction: Reported associations of diabetes with venous thromboembolism (VTE) are inconsistent. We conducted a systematic review and meta-analysis to quantify the association between diabetes mellitus (type 1 or 2) and VTE (deep vein thrombosis or pulmonary embolism). Methods: A systematic review of observational studies was conducted using PubMed, Web of Science, and CINAHL through Dec 31, 2012. Additional studies were identified by contacting experts and through manual review of reference lists of review articles and articles eligible for the present study. We abstracted information on relative risk (RR) estimates and pooled these data using a random-effects model. We queried authors of papers that did not adjust for important confounders to request controlled RR estimates. Results: We identified 10 studies (N participants: 240,940; 7 cohort, 3 case-control: Heit, Lidegaard, and Poulter) which provided RRs adjusted for age and BMI (Figure), and 8 additional studies which did not adjust for these confounders (N participants = 150,205). The pooled RR for the association of diabetes with VTE in the 10 studies was 1.18 (95% CI, 1.03-1.34). The test for heterogeneity was not significant (I 2 = 23.8%, p = 0.22). Amongst the 10 studies, smaller studies tended to have lower RR estimates: Both the Begg and Egger tests were significant (p = 0.02 and 0.01, respectively). The other 8 studies showed evidence of significant between-study heterogeneity (I 2 = 75.5%, p &lt;0.0001), making a pooled estimate inappropriate. Conclusions: Diabetes is associated with an 18% increased risk of VTE in observational studies after accounting for age and obesity. Possible explanations for the association of diabetes with VTE include increased hypercoagulability or vascular damage caused by the metabolic derangements of diabetes or increased exposure to VTE risk factors in individuals with diabetes. Further research is needed to elucidate the mechanisms of this association and whether improved control of diabetes is associated with reduced VTE risk.

A Clinical Rule (Sex, Contralateral Occlusion, Age, and Restenosis) to Select Patients for Stenting Versus Carotid Endarterectomy: Systematic Review of Observational Studies With Validation in Randomized Trials

A Clinical Rule (Sex, Contralateral Occlusion, Age, and Restenosis) to Select Patients for Stenting Versus Carotid Endarterectomy: Systematic Review of Observational Studies With Validation in Randomized Trials

Missing women? The health inequalities impact of low control and gender discrimination: a theory-led systematic review of observational studies

Missing women? The health inequalities impact of low control and gender discrimination: a theory-led systematic review of observational studies

The Role of Calcium in the Prevention of Cardiovascular Disease—A Review of Observational Studies and Randomized Clinical Trials

Calcium is a mineral that is important for bone health and has also been suggested to play a role in the prevention of cardiovascular disease (CVD). Lately, the potential effects of both inadequate and excessive calcium intake have received growing attention. In this review, we summarize the evidence from experimental, epidemiologic, and clinical studies investigating the role of calcium intake, either from the diet or from supplements, as well as blood concentrations, in relation to the risk of CVD in adults. In vitro and in vivo laboratory studies suggest that calcium may be involved in CVD development through multiple pathways, including blood cholesterol, insulin secretion and sensitivity, vasodilation, inflammatory profile, thrombosis, obesity, and vascular calcification. Several prospective epidemiologic studies have examined how dietary or supplemental calcium intake is associated with CVD incidence or mortality in middle-aged and older adults, and the results are inconsistent. Prospective studies investigating blood concentrations of calcium have also reported mixed results. However, changes in blood calcium concentrations may reflect a disturbed calcium phosphate balance, which is associated with increased risk of CVD. To date there is no randomized clinical trial that has been designed specifically to test the effect of calcium supplementation on the risk of CVD as the primary end point. Existing trials have performed secondary analyses, and most of them have been conducted among postmenopausal women. These trials suggest that calcium supplementation has no effect on CVD development; however, they do not allow a definitive conclusion to be drawn. The average daily intake of calcium is low in many populations; however, the evidence for a potential role of dietary or supplemental calcium in the prevention of CVD remains insufficient and inconclusive. Only large-scale randomized trials designed to investigate the effects of calcium supplementation on CVD events as the primary end point, as well as short-term trials investigating the effect on coronary biomarkers, can provide a definitive answer.

Mammography for Older Women?

Mammography for Older Women?

Letter to the Editor concerning “Efficacy of exercise therapy for the treatment of adolescent idiopathic scoliosis: a review of the literature” by Mordecai SC and Dabke HV (2012) Eur Spine J 21:382–389

Dear Editor, I have read with great interest and attention the review article by Mordecai and Dabke “Efficacy of exercise therapy for the treatment of adolescent idiopathic scoliosis: a review of the literature” [1]. The report adds a new insight into this controversial subject. However, I would like to express my concern regarding some aspects of this important paper. As stated by the authors, they were motivated by a need to produce an unbiased review of current evidence, in opposition to previous systematic reviews published by authors engaged in rehabilitation centres specializing in treatment of patients with scoliosis. The paper covers a structure of a systematic review, and taking into account the design of included reports, I assume that this is a systematic review of observational studies. Unfortunately, Mordecai and Dabke have not followed the MOOSE methodology for reporting this type of studies [2]. I am aware that the authors did not conduct a quantitative analysis of data retrieved from reports included in their review, but most MOOSE items are credible for systematic reviews without a meta-analysis. Also, the authors have provided a wide analysis of included papers in the text, but again, it would be much easier for a reader to draw firm conclusions if an appraisal tool, e.g., STROBE [2] or the Nottingham–Ottawa Scale (NOS) had been applied. Additionally, systematic reviews considered by Mordecai and Dabke could have been appraised with the AMSTAR, a measurement tool designed to assess methodological quality of systematic reviews [2]. An example from a very corresponding field of how systematic reviews, reports intended to support clinical decision making, may differ in methodology and conclusions, and how much confusion may follow, are the two secondary analyses regarding bracing for patients with scoliosis. In 1997, Rowe et al. [3] published a meta-analysis of the efficacy of non-operative treatments for idiopathic scoliosis, including data extracted from 14 reports on bracing, selected from two unpublished studies and 37 reports identified in a single textbook. The paper confirmed the efficacy of bracing, especially when braces are worn for 23 h a day. On the other hand, a recent Cochrane review informs, based on two studies meeting inclusion criteria (with a single RCT), selected from 1,285 identified titles, that bracing is controversial, and its effectiveness remains questionable [4]. The subject of scoliosis-specific exercises brings another illustration. A pilot report regarding the effectiveness of physical exercise therapy as a single intervention for patients with scoliosis, “most often cited in support of claims that exercise cannot be used to treat scoliosis” [5], had been excluded from the systematic review by Lenssinck et al. referred also by Mordecai and Dabke due to its low scientific rigour [6]. Thus, I found a lot of interesting points and plenty of discussion from independent specialists in this significant review, but uncertainities have remained unresolved. Perhaps the subject still awaits a more quantitative analysis of both primary and secondary reports, in accordance with recognised reporting guidelines and appraisal tools.

Psychological Differences Between Smokers Who Spontaneously Quit During Pregnancy and Those Who Do Not: A Review of Observational Studies and Directions for Future Research

Although remarkable interindividual differences among pregnant smokers' decision/ability to quit have been documented, the psychological factors that may account for these differences have received less attention and comprised the primary aim of this review. We searched the medical and behavioral sciences literature from 1996 to November 2011 using PubMed and PsycINFO(®). Fifty-one articles were identified based on titles or abstracts. These articles were reviewed in full and searched for quantitative observational studies of population-based or clinical samples, with the main topic of comparing smokers who quit spontaneously during pregnancy with those who did not, utilizing multivariable analyses. The eight pertinent studies reviewed herein included four longitudinal studies and four cross-sectional analyses. Amidst significant variability among measures used, social support, depressive symptoms, and anxiety appeared unrelated to smoking cessation during pregnancy. Furthermore, when severity of nicotine dependence was controlled, maternal history of attention-deficit/hyperactivity disorder, depression, bipolar disorder, and schizophrenia all showed no independent relationship with smoking cessation during pregnancy, whereas maternal history of conduct disorder did. Secure attachment, prosocial personality, self-esteem, and perceived parenting competence were additional predictors of cessation during pregnancy. A greater understanding of psychological factors that differentiate smokers who spontaneously quit during pregnancy from those who do not is crucial to the design of more effective prenatal smoking cessation interventions and also may elucidate causal mechanisms that underlie the well-established link between maternal smoking during pregnancy and offspring behavioral problems. Directions for future research and public health and policy implications are discussed.

The Impact of Mammographic Screening on Breast Cancer Mortality in Europe: A Review of Observational Studies

To assess the impact of population-based mammographic screening on breast cancer mortality in Europe, considering different methodologies and limitations of the data. We conducted a systematic literature review of European trend studies (n = 17), incidence-based mortality (IBM) studies (n = 20) and case-control (CC) studies (n = 8). Estimates of the reduction in breast cancer mortality for women invited versus not invited and/or for women screened versus not screened were obtained. The results of IBM studies and CC studies were each pooled using a random effects meta-analysis. Twelve of the 17 trend studies quantified the impact of population-based screening on breast cancer mortality. The estimated breast cancer mortality reductions ranged from 1% to 9% per year in studies reporting an annual percentage change, and from 28% to 36% in those comparing post- and prescreening periods. In the IBM studies, the pooled mortality reduction was 25% (relative risk [RR] 0.75, 95% confidence interval [CI] 0.69-0.81) among invited women and 38% (RR 0.62, 95% CI 0.56-0.69) among those actually screened. The corresponding pooled estimates from the CC studies were 31% (odds ratio [OR] 0.69, 95% CI 0.57-0.83), and 48% (OR 0.52, 95% CI 0.42-0.65) adjusted for self-selection. Valid observational designs are those where sufficient longitudinal individual data are available, directly linking a woman's screening history to her cause of death. From such studies, the best 'European' estimate of breast cancer mortality reduction is 25-31% for women invited for screening, and 38-48% for women actually screened. Much of the current controversy on breast cancer screening is due to the use of inappropriate methodological approaches that are unable to capture the true effect of mammographic screening.

Impact of Long-Term Antibiotic Use for Acne on Bacterial Ecology and Health Outcomes: A Review of Observational Studies

Acne is among the most common cutaneous disorder affecting most individuals by the time they reach adulthood. Management of acne can be quite a challenge and includes medications with significant side effects. We discuss the potential side effects of long-term antibiotic use. These side effects should be carefully weighed and monitored when designing a treatment plan.

Normal ranges of heart rate and respiratory rate in children from birth to 18years of age: a systematic review of observational studies

Normal ranges of heart rate and respiratory rate in children from birth to 18years of age: a systematic review of observational studies

The effects of exenatide bid on metabolic control, medication use and hospitalization in patients with type 2 diabetes mellitus in clinical practice: a systematic review

The objective of this systematic review was to assess the published literature on the effectiveness of exenatide twice daily (exenatide) in clinical practice, specifically its effects on haemoglobin A1c (A1C), fasting glucose (FG), weight, systolic blood pressure (SBP), medication use, hospitalization and cardiovascular disease (CVD) outcomes. A systematic literature search using the MEDLINE database of English language literature published between January 2005 and May 2011 was performed. The review included retrospective or prospective observational studies that included 100 or more patients per treatment group. A total of 15 studies meeting the inclusion criteria were identified. The studies revealed significant reductions of -0.4 to -0.9% in A1C, -10 mg/dl in FG, -2 to -11 kg in body weight and -2 to -11 mmHg in SBP. Statistically significant reductions in the use or dosage of either oral glucose-lowering medications or insulin after initiating exenatide treatment were found in every observational study that assessed medication changes, including reductions in dosage of up to 75% in sulphonylureas dosages, 22% in metformin, 66% in thiazolidinediones (TZD) or TZD combination therapy and 75% in prandial insulin. Exenatide-treated patients experienced significantly lower rates of all-cause and CVD-related hospitalization and CVD events than patients treated with other therapies overall. In this review of observational studies, exenatide initiation was associated with significant reductions in clinically relevant outcomes. Improvements in A1C, FG, weight and SBP in the observational studies in this review were consistent with improvements observed in controlled clinical trials.

Current status of the treatment of acute colonic diverticulitis: a systematic review

This paper addresses the current status of the treatment of acute colonic diverticulitis by an evidence-based review. A systematic search in PUBMED, MEDLINE, EMBASE and Google scholar on colonic diverticulitis was performed. Diagnostic tools, randomized controlled trials, non-randomized comparative studies, observational epidemiological studies, national and international guidelines, reviews of observational studies on elective and emergency surgical treatment of diverticulitis, and studies of prognostic significance were reviewed. Criteria for eligibility of the studies were diagnosis and classification, medical treatment, inpatients and outpatients, diverticulitis in young patients, immunosuppression, recurrence, elective resection, emergency surgery, and predictive factors. Some 92 publications were selected for comprehensive review. The review highlighted that computed tomography is the most effective test in the diagnosis and staging of acute diverticulitis; outpatient treatment can be performed for uncomplicated diverticulitis in patients without associated comorbidities; conservative treatment is aimed at those patients with uncomplicated acute diverticulitis; elective surgery must be done on an individual basis; laparoscopic approach for elective treatment of diverticulitis is appropriate but may be technically complex; in perforated diverticulitis, resection with primary anastomosis is a safe procedure that requires experience and should take into account strict exclusion criteria. The heterogeneity of patients with colonic diverticular disease means that both elective and urgent treatment should be tailored on an individual basis.

Dietary Habits and Prostate Cancer Prevention: A Review of Observational Studies by Focusing on South America

There exist several works considering the association between diet and prostate cancer (PC) risk, but the issue is largely unsettled. This article systematically reviews the epidemiological studies on diet and risk of PC focusing on those carried out in countries of South America. There is some suggestion that dairy products, red meat, processed meat, α-linolenic fatty acids, as well as dietary patterns characterized by higher intakes of red and processed meat, eggs, and grains may play some role in the development of PC. There is no clear association with the intake of vegetables and fruits, lycopene, fats, and different types of fatty acids. The evidence on diet and PC is therefore inconclusive in general and specifically in South America. Particular attention must be paid to the study of cancer risk in some countries of South America because of the singularly risky dietary pattern consumed by its population.

Asthma and suicide-related adverse events: a review of observational studies

Suicide is a major public health concern. There are several risk factors associated with suicide. Chronic illnesses, such as asthma, have been linked to an increased risk of suicide-related events. This study reviews the evidence of an association between asthma and suicide using published epidemiological observational studies. An electronic search using PubMed and EMBASE was performed. Studies that investigated the association of asthma with suicide-related behaviour were selected. Studies were examined to form a descriptive analysis. Six observational studies met the selection criteria, of which at least one suicide-related adverse event was studied. Three studies investigated completed suicide, two suicide attempts and four suicide ideation. Two of the studies focused on individuals aged <18 yrs. Evidence from observational data support the hypothesis of an association between asthma and suicide-related behaviour (ideation, attempts and completion); however, epidemiological studies, with more objective measures and larger sample sizes, adjusting for a wider scope of suicide-related confounding factors (e.g. comorbidities), and with a longitudinal design, are needed for a more conclusive answer.

Treatment of fecal incontinence – review of observational studies (OS) and randomized controlled trials (RCT) related to injection of bulking agent into peri-anal tissue

Treatment of fecal incontinence – review of observational studies (OS) and randomized controlled trials (RCT) related to injection of bulking agent into peri-anal tissue

Treatment of fecal incontinence - review of observational studies (OS) and randomized controlled trials (RCT) related to injection of bulking agent into peri-anal tissue.

PURPOSE: Novel treatments are needed to augment medical therapy for fecal incontinence. METHODS: Medline and Google search (fecal incontinence and injection treatment), English publications. RESULTS: Twenty-two observational studies and 4 randomized controlled trials were identified. OS mostly with limited sample sizes reported promising results. Repeated injection was necessary in some patients. Effect on anal sphincter pressures was highly variable. Significant improvements in the length of anal high-pressure zone, asymmetry index and maximum tolerable rectal volume were suggested. Four randomized controlled trials (n=176) revealed: 1. Short-term benefits from injection of Bioplastique under ultrasound guidance compared with digital guidance; 2. Silicone biomaterial (PTQ) provided some advantages and was safer than carbon-coated beads (Durasphere); 3. PTQ did not demonstrate clinical benefit compared to control injection of saline; 4. There was significant improvement at 6 weeks post injection, but no difference between Bulkamid and Permacol. A 2010 Cochrane review, however, noted that these data were inconclusive due to limited number and methodological weaknesses. CONCLUSION: Further studies are warranted to assess patient-centered outcomes (e.g. adequate relief) in addition to the attenuation of severity of incontinence symptoms in ambulatory patients. In nursing home residents, cost-effectiveness studies combining injection treatment and prompted voiding (to mitigate constraints of immobility and dementia) in preventing peri-anal skin complications deserves to be considered.

Tea Consumption and Epithelial Ovarian Cancer Risk: A Systematic Review of Observational Studies

Ovarian cancer is the seventh most common type of cancer in the United States and is often not diagnosed until late stages. Thus, identifying potential risk factors and prevention strategies is particularly important. This systematic review analyzes existing evidence on the association between tea consumption and epithelial ovarian cancer risk in human observational studies. PubMed was searched through September 30, 2010 for eligible articles; 16 articles met the inclusion criteria for this systematic review. Five studies found overall tea intake to be associated with a decreased epithelial ovarian cancer risk, 1 found a borderline decreased risk, 9 found no association, and 1 found a borderline increased risk. Overall, it does not appear that tea consumption increases risk of ovarian cancer, but there is insufficient evidence at this point to conclude that it is protective against ovarian cancer. Many of the studies included in this review had important limitations, especially related to the lack of detailed data collected on tea consumption. Further research is needed and should focus on more detailed assessment of type of tea consumed, frequency, and duration of tea intake. Future studies should also explore potential differences in the association between tea intake and ovarian cancer risk among subpopulations.

Normal Ranges of Heart Rate and Respiratory Rate in Children from Birth to 18 Years of Age: A Systemic Review of Observational Studies

Normal Ranges of Heart Rate and Respiratory Rate in Children from Birth to 18 Years of Age: A Systemic Review of Observational Studies