Informed Consent for Medical Research: Common Discrepancies and Readability

Objective: To identify common discrepancies and average reading grade levels for informed consent forms (ICFs) us submitted to institutional review boards (IRBs) by medical researchers.
Methods: A retrospective evaluation of ICFs as submitted to IRBs of 3 university-affiliated hospitals during a I-year period. ICF content was evaluated using a checklist of 23 requirements specified in the federal regulations governing human research. Documents then were computer-analyzed to determine the readability scores using 2 common indexes of comprehension. A discrepancy was defined as any instance in which an ICF did not address an applicable requirement in the Code of Federal Regulations.
Results: Eighty-two ICFs representing 16 medical specialties were evaluated; 8 (10%) were from emergency medicine. Eighteen ICFs (22%) were conspicuously incomplete, lacking 29 federal requirements. The mean number of discrepancies was 4.7 (95% CI, 3.9–5.5) Common omissions included: a statement about who is doing the research, number of subjects in the study, circumstances when a subject's participation may be terminated, disclosure of alternative procedures, and notice to subjects regarding new findings. The mean Flesch grade level required to read all ICFs was 13.8 (95% CI, 13.5–14.2), implying that the majority of the U.S. adult population would be unable to comprehend these forms.
Conclusion: Designing a consent form to meet all of the federal requirements while maintaining a level of reading comprehension suitable for the general population is a difficult task for investigators.     

A comparison of two microcomputer-based programs for bibliographic retrieval and formatting

We evaluated two representative microcomputer-based programs for organizing a biomedical literature filing system. With a bibliography of 100 anesthetic references, a series of benchmark tests was developed to measure the speed and accuracy of typical searching, sorting, and formatting tasks. Each program performed the searching tasks accurately and at about the same speed. One program performed sorting without errors, provided the field order of the template used to enter references was unchanged. Both programs used punctuation files, that is, templates for controlling author presentation; punctuation to suit style requirements of individual journals; and order of particular fields, such as publisher and year of publication. Each program was able to format journal, book, and chapter references correctly, but the resulting output required some refining in a word processor. Both require a major time commitment to learn and to create custom punctuation files for journals not included in the predesigned punctuation files. Once mastered, both programs are quite competent at organizing reprints and formatting journal references.     

Lack of efficacy of high-dose verapamil in preventing brain damage in baboons and pigs after prolonged partial cerebral ischemia

There has been mounting speculation that calcium antagonists may be useful in reducing or preventing brain damage after cardiopulmonary resuscitation. To test the clinical usefulness of these agents in averting such damage, high-dose verapamil was administered to baboons and pigs after partial cerebral ischemia for varying periods of time. In Group A baboons and pigs, the major aortic branches supplying the carotid and vertebral circulations were clamped for periods ranging from 15 to 150 minutes, and neurological recovery was observed. In Group B, verapamil hydrochloride 0.7 mg/kg was given by intravenous infusion after similar periods of arterial occlusion. The administration of verapamil did not lead to any clinically improved neurological outcome. The use of verapamil after prolonged periods of partial cerebral ischemia did not improve neurological recovery in baboons and pigs.     

Percutaneous biliary drainage in acute suppurative cholangitis

One hundred and sixteen percutaneous drainage procedures of the biliary system were performed in a 2-year period. Eight of 9 acutely ill patients with the diagnosis of acute suppurative cholangitis were successfully treated nonoperatively. They represented 26% of all patients with benign or postsurgical obstruction referred for biliary decompression. Conversely, acute suppurative cholangitis only occurred in 2.3% of patients with underlying malignant disease. These observations are considered most relevant in predicting the purulent nature of the disease, with further implications for patient management. Early recognition and prompt decompression of the biliary system are mandatory, along with the appropriate antibiotic coverage. Our experience compares favorably with surgical results and the procedure is proposed as the method of choice for the initial treatment of acute suppurative cholangitis.     

Movement disorders in women: A review

The field of women's health developed based on the recognition that there are important sex‐based differences regarding several aspects of medical illnesses. We performed a literature review to obtain information about differences between women and men for neurological movement disorders. We identified important differences in prevalence, genetics, clinical expression, course, and treatment responses. In addition, we found that female life events, including menstruation, pregnancy, breast feeding, menopause, and medications prescribed to women (such as oral contraceptives and hormone‐replacement therapy), have significant implications for women with movement disorders. Understanding this biological sex‐specific information can help improve the quality and individualization of care for women with movement disorders and may provide insights into neurobiological mechanisms. © 2013 International Parkinson and Movement Disorder Society