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At least 487 records · Page 27Linked to original sources
PubMed2006

Consent for genetics studies among clinical trial participants: findings from Action for Health in Diabetes (Look AHEAD).

BACKGROUND: Increasingly, genetic specimens are collected to expand the value of clinical trials through study of genetic effects on disease incidence, progression or response to interventions. PURPOSE: and methods We describe the experience obtaining IRB-approved DNA consent forms across the 19 institutions in the Action for Health in Diabetes (Look AHEAD), a clinical trial examining the effect of a lifestyle intervention for weight loss on the risk of serious cardiovascular events among individuals with type 2 diabetes. We document the rates participants provided consent for DNA research, identify participant characteristics associated with consent, and discuss implications for genetics research. RESULTS: IRB approval to participate was obtained from 17 of 19 institutions. The overall rate of consent was 89.6% among the 15 institutions that had completed consenting at the time of our analysis, which was higher than reported for other types of cohort studies. Consent rates were associated with factors expected to be associated with weight loss and cardiovascular disease and to affect the distribution of candidate genes. Non-consent occurred more frequently among participants grouped as African-American, Hispanic, female, more highly educated or not dyslipidemic. LIMITATIONS: The generalizabilty of results is limited by the inclusion/exclusion criteria of the trial. CONCLUSIONS: Barriers to obtaining consent to participate in genetic studies may differ from other recruitment settings. Because of the potentially complex associations between personal characteristics related to adherence, outcomes and gene distributions, differential rates of consent may introduce biases in estimates of genetic relationships.

Aged↗
PubMed2004

[Informed consent: a pragmatic view].

The author highlights some pragmatic aspects of informed consent that could help to bridge the gap between the currently valid legal requirements and the practical realities of providing medical information in Hungarian health-care settings. One of the crucial point of informed consent is whether the patient properly understood the provided medical information. Consequently, effective communication becomes an inevitable condition of providing informed consent. The results and insights coming from psychological research--concerning lay understanding of medical information, of the readability of consent forms, and especially of the lay understanding of statistical information, and risk communication--could help to create a better practice of medical communication that could satisfy both ethical and legal requirements. The author argues as well for creating more concrete and practically oriented guidelines concerning informed consent that would also help to increase the quality of medical information giving. These might help us approach the medical ideal that was conceptualised in the doctrine of informed consent.

Communication↗
PubMedDate not supplied

Obtaining family consent for participation in Alzheimer's research in a Cuban-American population: strategies to overcome the barriers.

Cultural values and beliefs affect family attitudes toward participation in research. Significant resistance to allowing their elders with dementia to participate in clinical research was encountered in Cuban-American families. These families expressed concern about disturbing the elder's comfort (tranquilidad) and solitude (soledad). Furthermore, most believed that intervention would be futile. Feelings of guilt associated with nursing home placement may have been exacerbated by the suggestion that active intervention could be effective. Strategies to overcome these barriers included reduced emphasis on the potential superiority of the intervention to be tested, reassurance that contact with research staff was usually appreciated by participants, arrangements to talk with the family as a group about the study, and increased use of Spanish-language consent forms.

Aged↗
PubMed1986

Communication and informed consent in clinical geriatrics.

Obtaining a valid informed consent from an elderly person, especially with possible senile dementia of the Alzheimer's type (SDAT), first may involve solving the practical problems of effective communication. Perceptual constraints that frequently occur in the elderly and that may interfere with communication, i.e., the sharing of information, are auditory and/or visual. The most common auditory obstacle, presbycusis (the hearing loss for pure tones due to normal aging) and other hearing impairments, may make the communication of any information about a proposed research project difficult, if not impossible, when not suspected and successfully overcome. Speech and language impediments, whether as a result of stroke or SDAT, are also common and need to be addressed if the person is to communicate his or her concerns and questions effectively with the researcher. Included in such constraints are the misunderstandings that arise from the use of confusing vocabulary, especially "medicalese." Presbyopia, cataract, and glaucoma are some of the visual constraints that may play an important role in making it difficult for the person to read the informed consent form. This article discusses these and other impediments to effective communication with SDAT elderly and makes suggestions how to obviate them.

Aged↗
PubMed1992

Avoiding malpractice claims for lack of informed consent.

While malpractice claims alleging lack of informed consent are proliferating, the courts are requiring more detailed information regarding the risks of proposed treatment. Increased use of consent forms and brochures designed to provide comprehensive, objective information for specific procedures could help physicians avoid most of these types of claims.

Acquired Immunodeficiency Syndrome↗
PubMed1995

Vasectomy counseling.

The following recommendations for counseling patients about vasectomy may help to minimize the risk of litigation for family physicians who provide vasectomy services: (1) conduct a personal consultation with the patient; (2) discuss the impact of vasectomy on sexual function; (3) explain the procedure using diagrams during the office visit for the physical examination; (4) explain possible minor complications and risks, including the possibility of failure; (5) explain the need for a postoperative semen analysis and the need to use another contraceptive method for a while after vasectomy; (6) emphasize the permanence of the procedure; (7) have the patient read and sign an informed consent form; (8) provide preoperative and postoperative instructions; (9) answer questions and respond to concerns, and (10) telephone the patient the day after the surgery.

Humans↗
PubMed1994

The duty to exclude: excluding people at undue risk from research.

The clinical trial is the major investigational tool of clinical medicine. Two recent reports highlight the fact that the most often quoted mechanisms for the protection of research subjects, viz., research ethics board review and eligibility criteria, are insufficient to achieve this end. In this paper, we argue that the prime mechanism for the protection of persons in clinical trials should be the clinical judgement of the physician-investigator. The clinical investigator has a duty to protect subjects from both harm and undue risk. It is argued that the clinical investigator has a duty to screen for, and exclude, potential research subjects who may be unduly vulnerable to the risks of a particular clinical trial. In order to fulfill this obligation, the investigator should personally screen each potential research subject at the time of accrual. In larger trials in which this is not feasible, this task could be delegated to another appropriately qualified health care professional, with the principal investigator retaining personal responsibility. To reinforce and make explicit this legal and moral duty, we propose that the investigator sign a statement, appended to each subject's consent form, to attest that this duty has been responsibly discharged.

Adult↗
PubMed1995

Parental perceptions and attitudes about informed consent in clinical research involving children.

We interviewed 64 parents by questionnaire after completion of a clinical trial involving their children for their perceptions and attitudes about informed consent. The results show that only a small minority realised that drug trials are designed to assess not only efficacy but safety as well. More worrisome was the majority of parents who felt that drug trials conducted by hospitals are of no or low risks. Moreover, a significant minority offered the view that the strict informed consent procedures we followed were unnecessary because they would do what the doctor advised. Even more worrisome was the small percentage of parents who realised that a signed consent form was primarily meant to protect their rights, and only one-third of the parents knew of their right to withdraw their child unconditionally from the trial at any time. These findings suggest that there may be significant attitudinal barriers to parental understanding of the informed consent process.

Adult↗
PubMed1995

Parental perceptions and attitudes about informed consent in clinical research involving children.

We interviewed 64 parents by questionnaire after completion of a clinical trial involving their children for their perceptions and attitudes about informed consent. The results show that only a small minority realized that drug trials are designed to assess not only efficacy but safety as well. More worrisome was the majority of parents who felt that drug trials conducted by hospitals are of no or low risks. Moreover, a significant minority offered the view that the strict informed consent procedures we followed were unnecessary because they would do what the doctor advised. Even more worrisome was the small percentage of parents who realized that a signed consent form was primarily meant to protect their rights, and only one-third of the parents knew of their right to withdraw their child unconditionally from the trial at any time. These findings suggest that there may be significant attitudinal barriers to parental understanding of the informed consent process.

Administration, Oral↗
PubMed2004

Medical litigation in cosmetic plastic surgery.

AIM: This article aims to highlight issues related to malpractice in plastic surgery and to point out the importance of good understanding of the law and the value of a patient's written informed consent as measures of professional protection. METHODS AND MATERIAL: Search of relevant literature from PubMed. RESULTS: The demand for cosmetic plastic surgery increases despite the increasing cost, in contrast to other traditional goods for which demand typically declines as price increases. Cosmetic plastic surgery has moved beyond the stage of being an exclusive privilege of the rich and famous. Nevertheless, cosmetic plastic surgery is one of the medical specialties exposed to a substantially high risk of malpractice claims. Most malpractice claims in cosmetic plastic surgery are not consequences of technical faults but because of inadequate patient selection criteria and lack of adequate communication between patient and surgeon. Proven efficient training, careful utilization of computer imaging techniques in association with the adoption of simple precautions and guidelines and adequate communication along with a completed patient's consent form are important essentials in case of medical litigation. CONCLUSIONS: In today's litigious society, maintenance of high standards in daily practice with continuous training and appropriate documentation of every procedure are all a sufficient defense of the plastic surgeon in case of medical litigation. Written patient's informed consent remains an integral part of the communication between physicians and patients, and importantly is facilitating professional protection.

Communication↗
PubMed2001

Thalidomide usage in Wales: the need to follow guidelines.

BACKGROUND: Thalidomide is a potentially useful drug for several dermatological disorders. OBJECTIVES: To assess prescribing and monitoring practices for this drug in Wales. METHODS: A questionnaire was completed by 17 of 19 consultant dermatologists concerning thalidomide usage in Wales (population 2.93 million). RESULTS: Eleven of the 17 respondents had used thalidomide in 40 patients. Only two consultants gave information leaflets and only five obtained written consent. Four obtained baseline nerve conduction studies and nine obtained these during therapy. Of seven women of child-bearing age currently taking thalidomide, none had had baseline pregnancy tests. CONCLUSIONS: We describe variability in prescribing practices for thalidomide. Published guidelines are reviewed and suggestions made concerning consent forms, pregnancy testing, nerve conduction studies and patient information.

Dermatologic Agents↗
PubMedDate not supplied

[Patient's consent to central venous catheterization].

The need to obtain a patient's consent for his health care is a principle set out in the Italian Constitution, which safeguards a person's right to health. Articles 13 and 32.2 confirm a person's freedom and the right to make free decisions about one's medical treatment. Nobody must be obliged to any medical procedure, unless as by law enacted. The obligation to inform patients is important during the contractual phase: consent is an essential element in the professional contract governing the relationship between a physician and a patient. The former is obligated to inform the latter about his medical intervention clearly and precisely, to enable the patient to decide freely whether to undergo a medical procedure. At this point, it is also essential to obtain a patient's consent for those treatments that although they are carried out in a correct and careful way, could damage a person's physical integrity. The failure to obtain consent could give rise to a burden of responsibility on behalf of the clinician. A central venous catheterization in hemodialysis (HD) is a common procedure performed during routine nephrological treatments. Our signed informed consent form prior to introducing a central venous catheter is thought to satisfy requirements provided for in current regulations to give correct information.

Catheterization, Central Venous↗
PubMed1998

[Preoperative information and informed consent in surgically treated patients].

OBJECTIVE: Providing information is an important part of the doctor-patient relationship. In hospital practice today, patients and/or their families are sometimes given seriously inadequate information. Our aim was to analyze the quality of information received by patients before anesthesia and surgery. PATIENTS AND METHODS: The opinion of 300 patients (141 men and 159 women) at Hospital Universitario "Virgen de la Arrixaca" (Murcia, Spain) was studied from 1993 to 1995. The sample was a stratified random one with sex and age as the classifying variables. Surgery was scheduled in 150 cases and emergency in 150. Mean age was 42.88 +/- 1.20 years (SD = 20.84; range 3-90 years). RESULTS: Patients were unfamiliar with risks of surgery and anesthesia in 19% and 18.3% of the cases, respectively. No information was received by 69.3% of patients regarding surgical risks and an even higher 75% of patients received no information on risks of anesthesia. In 3.6% of scheduled operations, neither patient nor family members were required to sign a consent from, though these cases involved patients under 18 years of age. For emergency surgery this percentage was 5.4%. Lack-of-information percentages are higher in operations requiring local or regional anesthesia. CONCLUSIONS: We must underline the poor quality of patient knowledge about medical procedures and the scarce information provided. Even fewer patients known about the risks of anesthesia. A patient's signing of an informed consent form does not correspond to real knowledge of the risks involved in the procedure.

Aged↗
PubMed2006

Evaluation of the validity of the Foot Function Index in measuring outcomes in patients with foot and ankle disorders.

BACKGROUND: There is uncertainty regarding which outcomes tools should be used to report the results of treatment for patients with foot and ankle disorders. This study evaluates the validity of the Foot Function Index (FFI) by examining its level of correlation to the Medical Outcomes Study Short Form-36 (SF-36). The SF-36 is an extensively validated outcomes tool that has been used as a benchmark in examining the validity of several orthopaedic outcomes tools. METHODS: Seventy-three patients were recruited at a tertiary referral foot and ankle practice. Patients completed packets which included informed consent forms, the FFI, and the SF-36 questionnaires. The questionnaires were scored and Pearson correlation coefficients were determined between the three domains of the FFI and the eight SF-36 sub-scales, as well as the two SF-36 summary scales. RESULTS: Sixty-nine patients completed an adequate number of items to be included in the study. The mean age of the patient sample was 46 (range 16 to 82) years and 44 were women (64%). Twenty-one patients (30%) had conditions affecting the forefoot, while 48 patients (70%) had conditions affecting the ankle or hindfoot. All three FFI domains had moderate to high levels of correlation to many of the SF-36 scales. The Disability domain of the FFI had the most consistent level of correlation to the SF-36 with Pearson coefficients in the range of -0.23 to -0.69. The Activity Limitation (r=-0.28 to -0.64) and Pain domains (r=-0.10 to -0.61) also demonstrated moderate levels of correlation to several of the SF-36 scales. CONCLUSIONS: The consistently moderate to high levels of correlation of the FFI to the SF-36 seen in this study support the FFI as a valid measure of health status. This suggests that the FFI is a reasonable method to monitor patient outcomes. Future studies should focus on determining if the FFI improves responsiveness to clinical change when used in combination with generic instruments like the SF-36.

Adolescent↗
PubMed2004

Treatment of in-stent restenosis for saphenous vein grafts using intravascular brachytherapy: regulatory challenges and clinical application.

Treatment of in-stent restenosis using intravascular brachytherapy (IVBT) has been demonstrated to be successful and has become the standard of care for native coronary artery disease. Based on the current Food and Drug Administration (FDA) indications for use and the clinical demand to increase the scope of this form of therapy to include saphenous vein grafts for the Beta-Cath System (Novoste Corporation, Norcross, Georgia), we set out to obtain institutional approval for off-label use. Identification of institutional regulatory bodies and related procedures for obtaining off-label device use was performed. Additionally, the IVBT written directive proscription and patient informed consent forms were revised to accurately administer radiation dose and to disclose the regulatory status of using IVBT for this anatomic site. While the specifics are outlined in this report, this process and the resources needed to obtain institutional approval for off-label use are indicative of that to be expected at similar institutions.

Blood Vessel Prosthesis Implantation↗
PubMed1995

Ethical considerations in the use of neuromuscular blockades.

The long-term use of neuromuscular blocking agents in the adult intensive care unit is clinically and ethically challenging. These drugs can be dramatically lifesaving; they also have the potential of causing the patient great emotional, spiritual, and physical harm. Traditional ethical analysis is important but may not be adequate. Rigorous attention should be given to risk-benefit ratios, informed consent, and quality of life. It is suggested that institutions develop written consent forms and information sheets, use adapted values history forms in assessing treatment decisions and quality of life, and fully utilize ethics committees and patient care conferences in caring for these catastrophically ill patients.

Critical Care↗
PubMed1997

Recruitment issues in school-based research: lessons learned from the High 5 Alabama Project.

School-based research requires a multi-level recruitment process to ensure an adequate sample. This article describes the High 5 Alabama recruitment experience at four levels; district, school, classroom and individual. One hundred percent of 28 schools across three districts and 108 classroom teachers contacted agreed to participate. Moderate success (69%) at the individual level, which required active parental consent for the student and parent to participate, resulted in 1,698 student/parent participants. An examination of differences between participants and nonparticipants revealed under-representation of a subsample of the population in the project sample. Suggestions obtained from project staff and teachers intended to enhance future school-based recruitment strategies include enlistment of a district advocate; meeting with teachers to solicit support; using incentives with students and teachers; direct contact with parents; having teachers keep rosters of students returning consent forms; and tailoring recruitment strategies for specific subpopulations.

Adolescent↗
PubMed1999

Use and abuse of bite splints.

Bite splints are often used in the treatment of patients with oral parafunctions, temporomandibular joint (TMJ) dysfunction, or temporomandibular disorders. The most common reasons for prescribing a bite splint are to protect the teeth in patients with bruxism, to improve jaw-muscle and TMJ function, and to relieve related pain. The risk for negative side effects is small in conservative bite splint treatment. Complications from long-term use of splints, however, can be severe and irreversible. The risks are especially high when mandibular advancement splints, or splints that make contact only with parts of the opposing dentition, are used for more than 4 to 6 weeks without appropriate supervision. As a general rule, a dentist should not encourage a patient to use any type of splint for more than a few months except for cases in which the teeth need to be protected because of persistent oral parafunctions. Appropriate record keeping, including signed consent forms, is necessary; when neglected, it becomes difficult for the dentist to defend himself from false accusations of malpractice.

Bruxism↗