Articles: prospective-studies.
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J. Korean Med. Sci. · Sep 2012
Multicenter Study Clinical TrialAntihypertensive treatment of acute intracerebral hemorrhage by intravenous nicardipine hydrochloride: prospective multi-center study.
The authors performed a multicenter prospective study to evaluate the feasibility and safety of intravenous nicardipine hydrochloride for acute hypertension in patients with intracerebral hemorrhage (ICH). This study included 88 patients (mean age: 58.3 yr, range 26-87 yr) with ICH and acute hypertension in 5 medical centers between August 2008 and November 2010, who were treated using intravenous nicardipine. ⋯ Neurological deterioration (defined as a decrease in initial Glasgow coma scale ≥ 2) was observed in 2 (2.2%) of 88 patients during the treatment. Aggressive nicardipine treatment of acute hypertension in patients with ICH can be safe and effective with a low rate of neurological deterioration and hematoma expansion.
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The data on incidence of hypopituitarism after SAH are conflicting. Furthermore, it is still not known whether there is any difference in hormonal deficiencies between SAH due to anterior communicating artery (A-com) and middle cerebral artery (MCA) aneurysms. ⋯ Hormonal deficiencies are not uncommon in patients with SAH. There is no difference in hormonal deficiencies and severity of hypopituitarism in patients with SAH due to A-com and MCA bleed.
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In both the United States and Europe there has been an increased interest in using comparative effectiveness research of interventions to inform health policy decisions. Prospective observational studies will undoubtedly be conducted with increased frequency to assess the comparative effectiveness of different treatments, including as a tool for "coverage with evidence development," "risk-sharing contracting," or key element in a "learning health-care system." The principle alternatives for comparative effectiveness research include retrospective observational studies, prospective observational studies, randomized clinical trials, and naturalistic ("pragmatic") randomized clinical trials. ⋯ The task force emphasizes the need for precision and clarity in specifying the key policy questions to be addressed and that studies should be designed with a goal of drawing causal inferences whenever possible. If a study is being performed to support a policy decision, then it should be designed as hypothesis testing-this requires drafting a protocol as if subjects were to be randomized and that investigators clearly state the purpose or main hypotheses, define the treatment groups and outcomes, identify all measured and unmeasured confounders, and specify the primary analyses and required sample size. Separate from analytic and statistical approaches, study design choices may strengthen the ability to address potential biases and confounding in prospective observational studies. The use of inception cohorts, new user designs, multiple comparator groups, matching designs, and assessment of outcomes thought not to be impacted by the therapies being compared are several strategies that should be given strong consideration recognizing that there may be feasibility constraints. The reasoning behind all study design and analytic choices should be transparent and explained in study protocol. Execution of prospective observational studies is as important as their design and analysis in ensuring that results are valuable and relevant, especially capturing the target population of interest, having reasonably complete and nondifferential follow-up. Similar to the concept of the importance of declaring a prespecified hypothesis, we believe that the credibility of many prospective observational studies would be enhanced by their registration on appropriate publicly accessible sites (e.g., clinicaltrials.gov and encepp.eu) in advance of their execution.
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The majority of patients seeking medical treatment for snakebites do not suffer from severe envenomation. However, no guidelines exist for ordering coagulation markers in patients with minimal or moderate envenomation, nor in those who do not receive antivenom. In this study, we sought to determine whether it was possible to limit the practice of ordering coagulation studies to those patients suffering severe envenomation, rattlesnake envenomation, or both. ⋯ Our study failed to identify a subset of patients that could be defined as low risk or for whom coagulation marker testing could be foregone. This study suggests that coagulation tests should be routinely performed on all patients presenting to the ED with complaints of envenomation by copperheads, moccasins, or rattlesnakes. Further clarification of when coagulation markers are indicated may require a prospective study that standardizes snake identification and the timing of coagulation marker testing.
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GMS Health Technol Assess · Jan 2012
Bone graft substitutes for the treatment of traumatic fractures of the extremities.
HEALTH POLITICAL AND SCIENTIFIC BACKGROUND: Bone graft substitutes are increasingly being used as supplements to standard care or as alternative to bone grafts in the treatment of traumatic fractures. ⋯ The current evidence is insufficient to evaluate entirely the use of different bone graft substitutes for fracture treatment. From a medical point of view, BMP-2 is a viable alternative for treatment of open fractures of the tibia, especially in cases where bone grafting is not possible. Autologous bone grafting is preferable comparing to the use of OP-1. Possible advantages of CaP cements and composites containing bone marrow over autogenous bone grafting should be taken into account in clinical decision making. The use of the hydroxyapatite material and allograft bone chips compared to autologous bone grafts cannot be recommended. From a health economic perspective, the use of BMP-2 in addition to standard care without bone grafting is recommended as cost-saving in patients with high-grade open fractures (Gustilo-Anderson grade IIIB). Based on the current evidence no further recommendations can be made regarding the use of bone graft substitutes for the treatment of fractures. To avoid legal implications, use of bone graft substitutes outside their approved indications should be avoided.