Search PubMed⌕ Search

SEARCH · Search PubMed

Results for “Consent Forms”

Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 991 records · Page 55Linked to original sources
PubMed2006

Chart documentation of informed consent for operative vaginal delivery: is it adequate?

OBJECTIVES: To determine the documentation frequency of informed consent for women undergoing a trial of nonemergent instrumental delivery. STUDY DESIGN: A retrospective chart review of instrumented vaginal deliveries from 1992 to 2005 was performed. Cases were identified from a Labor and Delivery database and hospital records were reviewed for documentation of associated risks, general consent for the procedure, indication, and option of cesarean delivery (CD). RESULTS: Three hundred forty six charts were reviewed: 246 were excluded for an emergency delivery (19%), misclassification (25%), or lost notes (27%). In the remaining 100 cases, 61% had a general consent for instrumented vaginal delivery. Documentation of any maternal or neonatal risks was found in 3% and 0%, respectively. The option of a cesarean delivery was documented in 22% of the cases. When comparing 5-year time intervals before and after 2000, there was no increased frequency in documentation of maternal or neonatal risks. CONCLUSIONS: Documentation of informed consent for instrumented vaginal delivery is inconsistent and should be improved.

Consent Forms↗
PubMed1993

Who's afraid of informed consent?

OBJECTIVE: To test the assumption that patients will become unduly anxious if they are given detailed information about the risks of surgery in an attempt to obtain fully informed consent. DESIGN: Preoperative anxiety assessed before and after patients were randomly allocated an information sheet containing either simple or detailed descriptions of possible postoperative complications. SETTING: Four surgical wards at two Sheffield hospitals. SUBJECTS: 96 men undergoing elective inguinal hernia repair under general anaesthesia. MAIN OUTCOME MEASURE: Change in anxiety level observed after receiving information about potential complications. RESULTS: Detailed information did not increase patient anxiety (mean Spielberger score at baseline 33.7 (95% confidence interval 31.3 to 36.2), after information 34.8 (32.1 to 37.5); p = 0.20, paired t test). A simple explanation of the facts provided a statistically significant degree of reassurance (mean score at baseline 34.6 (31.5 to 37.6), after information 32.3 (29.8 to 34.9); p = 0.012), although this small effect is likely to be clinically important only in those whose baseline anxiety was high (r = 0.27, p = 0.05). CONCLUSIONS: In men undergoing elective inguinal hernia repair a very detailed account of what might go wrong does not increase patient anxiety significantly and has the advantage of allowing patients a fully informed choice before they consent to surgery, thus reducing the potential for subsequent litigation.

Anxiety↗
PubMed1992

Use of informed consent for ionic and nonionic contrast media.

The use of informed consent before intravenous administration of contrast material remains a controversial issue. It involves explaining the risks of intravenous contrast material and obtaining the patient's permission for its use. All physician groups who had billed Pennsylvania Blue Shield for at least three intravenous contrast material-enhanced procedures performed in 1989 were surveyed. Informed consent was obtained from at least some patients by about two-thirds of physician groups before using intravenous contrast material, regardless of whether it was ionic or nonionic. Nonradiologists were more likely to obtain informed consent before the use of ionic contrast material than radiologists. Regardless of specialty, practices associated with larger hospitals (greater than 250 beds), larger physician groups (greater than 10), or a university used informed consent less often than smaller physician groups or those associated with a smaller hospital or a private practice. Though results may be affected by regional variation or increased usage since previous surveys, the use of informed consent before the intravenous injection of contrast material is a common practice; it is obtained in the majority of patients.

Attitude of Health Personnel↗
PubMed2004

Passive versus active parental permission in school-based survey research: does the type of permission affect prevalence estimates of risk behaviors?

This study investigates whether the type of parental permission affects prevalence estimates for risk behaviors from the national 2001 Youth Risk Behavior Survey. Participants were 13,195 students from 143 schools, of which 65% used passive permission and 35% active permission. Student participation rates were 86.7% in passive permission schools and 77.3% in active permission schools. For 24 of 26 behaviors tested, no significant differences were seen in the prevalence of risk behavior by type of parental permission. As long as high response rates are obtained, type of parental permission does not affect prevalence estimates for risk behaviors that are based on self-report.

Adolescent↗
PubMed2003

Recall of the risks of forefoot surgery after informed consent.

PURPOSE: To determine the number of risks a patient can recall from the informed consent process prior to surgery and if recall can be improved with a visual aid and to assess patient satisfaction with the informed consent process utilized. METHODS: Randomly selected patients, from all patients requiring forefoot surgery, were randomly assigned into two groups from August 2001 through October 2001. All patients were asked to recall the risks of surgery and to rate their satisfaction with the informed consent process at their final routine postoperative visit. RESULTS: There were 19 patients in each group. All patients uniformly expressed their satisfaction with the preoperative informed consent discussion at their final visit. The mean number of the 11 risks recalled per patient was 1.0 for group A (range, 0-3) and 0.94 for group B (range, 0-4). CONCLUSION: At the final routine postoperative visit, patients in both groups had poor or no recall of the risks of surgery. The visual aid had no effect on improving recall.

Audiovisual Aids↗
PubMed2003

Randomized, controlled trial of an easy-to-read informed consent statement for clinical trial participation: a study of the Eastern Cooperative Oncology Group.

PURPOSE: Studies have documented that the majority of consent documents for medical diagnosis and treatment are written at a reading level above that of the majority of the U.S. population. This study hypothesized that use of an easy-to-read consent statement, when compared with a standard consent statement, will result in higher patient comprehension of the clinical treatment protocol, lower patient anxiety, higher patient satisfaction, and higher patient accrual. METHODS: A randomized controlled trial was conducted in 44 institutions that were members or affiliates of three cooperative oncology groups. Institutions were randomly assigned to administer either an easy-to-read consent statement or the standard consent statement to patients being recruited to participate in selected cancer treatment trials. Telephone interviews were conducted with a total of 207 patients to assess study outcomes. RESULTS: Patients in the intervention arm demonstrated significantly lower consent anxiety and higher satisfaction compared with patients in the control arm. Patient comprehension and state anxiety were not affected by the intervention. Accrual rates into the parent studies also did not differ significantly between the two study groups. CONCLUSION: Clinical trial informed consent statements can be modified to be easier to read without omitting critical information. Patient anxiety and satisfaction can be affected by the consent document. The generalizability of these study results is limited by the characteristics of the patient sample. Ninety percent of the sample were white women, and the mean Rapid Estimate of Adult Literacy in Medicine score was approximately 64, indicating a literacy level at or above the ninth grade.

Clinical Protocols↗
PubMed1986

Procedures requiring signed consent. A survey of practice.

Despite extensive discussion of informed consent within the medical and legal literature, those diagnostic or therapeutic procedures which may specifically require written consent remain poorly identified. Survey results from 105 JCAH-approved hospitals show that 56 percent set forth a general policy statement regarding when and for which procedures consent is needed. The remaining hospitals specify individual procedures for which signed authorization is required by the hospital or medical staff guidelines. The potential liability, advantages and disadvantages of a general versus specific consent practice are discussed. A listing of those procedures itemized by responding hospitals from this national survey is also presented.

Consent Forms↗