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PubMedDate not supplied

Methodologic issues in the conduct and interpretation of pediatric effectiveness research.

Effectiveness research represents a number of methodologic challenges not shared with randomized, controlled clinical trials. This practice-based research attempts to translate clinical practices to a wide variety of different practice settings and situations and to diverse patient subgroups. However, because study designs most often used in the conduct of effectiveness research limit the ability to establish firm causal links between medical care and outcomes, it is important to address key methodologic features to generate sound, useable findings. Such features include selection of appropriate outcome measures (with a priori hypotheses linking care to the outcomes chosen), specification of appropriate primary sampling unit, specification of unit of analysis, establishment of appropriate comparison groups, and case-mix adjustment. Conduct of this type of research in pediatrics presents a number of unique methodologic concerns that either do not apply in adult medicine or are particularly acute in pediatrics. To alert policy makers and funders to the unique aspects of pediatric health services research and to provide guidance for the conduct and interpretation of pediatric effectiveness studies, we have organized and described the methodologic issues associated with the specific type of pediatric care under study (eg, specific disease-prevention, "bundled" care for chronic disease, care for problems with social etiologies, etc). We conclude with a summary of the methodologic steps that are critical to the conduct of sound effectiveness research in pediatrics.

Child↗
PubMed2003

The STARD statement for reporting studies of diagnostic accuracy: explanation and elaboration.

The quality of reporting of studies of diagnostic accuracy is less than optimal. Complete and accurate reporting is necessary to enable readers to assess the potential for bias in the study and to evaluate the generalisability of the results. A group of scientists and editors has developed the STARD (Standards for Reporting of Diagnostic Accuracy) statement to improve the reporting the quality of reporting of studies of diagnostic accuracy. The statement consists of a checklist of 25 items and flow diagram that authors can use to ensure that all relevant information is present. This explanatory document aims to facilitate the use, understanding and dissemination of the checklist. The document contains a clarification of the meaning, rationale and optimal use of each item on the checklist, as well as a short summary of the available evidence on bias and applicability. The STARD statement, checklist, flowchart and this explanation and elaboration document should be useful resources to improve reporting of diagnostic accuracy studies. Complete and informative reporting can only lead to better decisions in healthcare.

Algorithms↗
PubMedDate not supplied

Public health response to urgent case reports.

We evaluated the ability of local public health agencies (LPHAs) to meet a preparedness standard set by the U.S. Centers for Disease Control and Prevention (CDC): to receive and respond to urgent case reports of communicable diseases twenty-four hours a day, seven days a week. We found substantial variability in performance and in the systems in place to respond to such reports. Development and implementation of measures of public health agencies' performance are crucial to improving public health preparedness and, ultimately, to assuring the agencies.

Centers for Disease Control and Prevention, U.S.↗
PubMed2003

Treatment of stage IIIA non-small cell lung cancer.

Stage IIIA non-small cell lung cancer represents a relatively heterogeneous group of patients with metastatic disease to the ipsilateral mediastinal (N2) lymph nodes and also includes T3N1 patients. Presentations of disease range from apparently resectable tumors with occult microscopic nodal metastases to unresectable, bulky multistation nodal disease. Controversy abounds as to the optimal treatment of the various stage IIIA subsets, which is fueled by a lack of meaningful, large randomized trials. Multimodality therapy of some type appears to be preferable in stage IIIA patients.

Carcinoma, Non-Small-Cell Lung↗
PubMed2005

Protection of human subjects in clinical research: the pitfalls in clinical research.

Clinical trials are an important part of medical research and must be done with good conduct and intention. Using a suitable approach is part of research practice, which favors protection of research subjects. Good Clinical Practice is being promulgated as a universal ethical approach toward protection of the human subject's rights. Appropriate scientific design, good performance, better analyses, informed consent, and credible scientific data with the confidentiality of the research subject all contribute to Good Clinical Practices. The first and possibly the most important step toward protection of the research subject is to appropriately obtain an informed consent, which identifies respect, beneficence, and justice for the enrolled research subjects.

Clinical Trials as Topic↗
PubMed2001

Intravesical valrubicin in the treatment of carcinoma in situ of the bladder.

The propensity of patients with carcinoma in situ (CIS) of the bladder to progress to invasive and metastatic disease is clearly established. Today, the standard therapy in treating patients with CIS of the bladder is intravesical bacillus Calmette-Guerin (BCG). Nevertheless, patients who fail intravesical BCG have few viable options except to undergo a radical cystectomy. Valrubicin (N-trifluoroacetyladriamycin-14-valerate) is a new semisynthetic derivative of the anthracycline antibiotic doxorubicin that has been shown to benefit patients with BCG-refractory CIS of the bladder. Intravesical instillation of valrubicin is well-tolerated, safe and can be durable. Early non-randomised studies show promise and the current utilisation of this drug is limited to patients with BCG-refractory CIS of the bladder who are not good surgical candidates. Randomised studies of intravesical valrubicin for the treatment of superficial bladder cancer are ongoing.

Administration, Intravesical↗
PubMed2006

Neurocardiogenic syncope: latest pharmacological therapies.

Neurocardiogenic syncope is a neurally mediated disorder and is a common cause of syncope. The goal of treatment is to prevent recurrences with the aim of improving quality of life and reducing morbidity. Reassurance, in some cases, may suffice. In others, augmenting central blood volume by increasing fluid and/or salt intake is effective. The role of non-pharmacological physical manoeuvres is increasingly recognised, given the increasing clinical trial data supporting their efficacy. This review summarises the clinical evidence for a variety of pharmacological agents. Of these, midodrine appears to have yielded the most consistent favourable outcome. Its use, however, should be reserved for patients with recurrent and refractory syncope.

Adrenergic alpha-Agonists↗
PubMed1998

The relationship between low back discomfort ratings and the NIOSH lifting index.

An epidemiological study was performed to evaluate the relation between low-back discomfort ratings and use of the revised NIOSH lifting guide to assess the risk of manual material handling (MMH) tasks. We surveyed 97 MMH workers on site in 15 factories and designed a questionnaire to systematically collect job-related information. Approximately 90% of the workers had suffered various degrees of lower back discomfort, and 80% had sought medical treatment. The survey showed that 42 of the 97 jobs analyzed had a recommended weight limit of 0, which was attributed to either a horizontal distance or a lifting frequency that exceeded the bounds of the NIOSH lifting index. Apparently, the limits for horizontal distance and maximum allowable frequency are too stringent to accommodate many existing MMH jobs. For the remaining 55 jobs, the significant positive correlation obtained between the lifting index and the severity of low-back discomfort suggests that the lifting index is reliable in assessing the potential risk of low-back injury in MMH. These findings provide useful information on the application of the NIOSH lifting guide to the assessment of low-back pain.

Adolescent↗