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PubMed2004

Perinatal pathology in the context of a clinical trial: attitudes of neonatologists and pathologists.

OBJECTIVE: To describe the attitudes of neonatologists to trial related perinatal postmortem examinations (PMs), in the light of declining perinatal PM rates and poor levels of participation in pathology studies. METHODS: A qualitative study was carried out, using semistructured interviews. Twenty six neonatologists from five UK neonatal units were interviewed; five UK perinatal pathologists also contributed to the study. The professionals involved were all linked to one or both of two neonatal trials. RESULTS: Pathologists expressed concern over the difficulties experienced in UK perinatal pathology and the impact on research of inadequate levels of samples. The interviews with neonatologists reveal discomfort over approaching bereaved parents for PMs, and a widespread concern that parents should not be further distressed or feel under pressure to consent. Although there was support for neonatal trials, the study highlights a view that PMs may be unnecessary if the cause of death seems apparent or when a baby was born prematurely, and a devaluation of PMs among some younger staff. Poor rates of participation in pathology studies may be accounted for by a notable sense of disconnection between trial interventions and pathology studies. CONCLUSIONS: Neonatologists were concerned to protect vulnerable parents and varied in whether they saw this as compatible with inclusion in trial related pathology studies. Dedicated research is needed to document and gain an understanding of the consent process and should examine the usefulness and impact of consent forms. It should assess whether professionals might benefit from training, to help parents to come to their decisions.

Adult↗
PubMed1999

[Methodological aspects of biostatistics and epidemiology in a clinical trial].

Various methodological issues in biostatistics and epidemiology which are relevant for the development of a clinical trial are discussed. A brief set of definitions regarding clinical trials and methods for the assignment of treatments is presented. In addition, methods to reduce the possibility of bias that may be introduced into a clinical trial are summarized. The different elements that must be included in the informed consent form are defined. General considerations for data analysis and for sample size required to obtain an adequate statistical power are illustrated. Finally, critical questions that can be used for the review of the literature on clinical trials are suggested.

Aged↗
PubMed2006

Responsiveness of the foot function index, AOFAS clinical rating systems, and SF-36 after foot and ankle surgery.

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 compared the responsiveness of the Foot Function Index (FFI), American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating Systems, and Medical Outcomes Study Short Form-36 (SF-36) in patients with foot and ankle surgery. METHODS: Twenty-five patients were recruited at a tertiary referral foot and ankle practice. The mean age of the patient sample was 40 years (range 21 to 69) and 19 were women (76%). Thirteen patients (52%) had conditions affecting the ankle, hindfoot, or midfoot, while 12 patients (48%) had conditions affecting the forefoot. Patients completed packets preoperatively and 6-months postoperatively which included informed consent forms, the FFI, the AOFAS, and the SF-36 questionnaires. Standardized response means (SRM) and effect sizes (ES) were used as the measures of responsiveness and were calculated for the AOFAS scores, the three domains of the FFI, the eight SF-36 sub-scales, and the two SF-36 summary scales. RESULTS: The standardized response mean (SRM) for the AOFAS scores was 1.10 and the effect size (ES) was 1.12. The SRM for the three FFI domains ranged from -0.39 to -0.83, while the ES ranged from -0.55 to -0.86. The SRM for the SF-36 ranged from 0.09 to 0.72 (ES ranged from 0.09 to 0.77) with the highest values occurring with the Bodily Pain sub-scale (SRM 0.72, ES 0.77) and Physical Component Summary scale (SRM 0.76, ES 0.68). CONCLUSIONS: This study demonstrated increased responsiveness of foot and ankle specific outcomes tools compared to the SF-36. However, the Bodily Pain sub-scale and Physical Component Summary scale of the SF-36 had levels of responsiveness approaching those of the FFI and AOFAS Systems after foot and ankle surgery. This suggests that the SF-36 may be used alone to monitor the outcomes in these patients without sacrificing adequate sensitivity to clinical change.

Adult↗
PubMed1985

Use of influenza vaccine in nursing homes.

The organization and outcome of influenza immunization programs were studied in 67 randomly or systematically selected nursing homes (8354 residents) in six states during the autumn of 1982 and/or 1983. In each home, influenza vaccine was usually offered to all residents on a voluntary basis, independent of their age, level of required nursing care, or underlying medical conditions. However, the proportion of residents who were vaccinated ranged from 8 to 98% (mean, 62% overall), with significantly lower rates in homes that also required consent from relatives (usually by return mail) than in homes that did not (P less than .00001; median, 57 versus 90%, respectively). These observations suggest that distribution of educational materials about the risks and benefits of influenza vaccine and systematic follow-up of relatives who fail to return the consent form may be useful strategies to further increase the number of nursing home residents who are immunized.

Aged↗
PubMed2006

[Problems in hospital preparation of acute poisoning antagonist (methylene blue injection)].

Since some antagonists or antidotes in cases of acute poisoning are not commercially available in Japan, in many hospitals they are prepared on their premises for clinical use. However, no specific legislation for the procedures of quality assurance and informed consent of these hospital-prepared products as yet exists. Further, the standard procedures for clinical use of the hospital-prepared products have yet to be established. For the treatment of patients with methemoglobinemia, we prepared methylene blue for injectable use in our hospital. In this paper, we describe our procedures ranging from its preparation to clinical use of this product. Methylene blue injection was prepared by using reagent-grade chemicals. The quality of hospital-prepared methylene blue injection was examined in accordance with the United States Pharmacopoeia. The contents of methylene blue injection remained constant at room temperature during storage for 12-month. The sterility testing also gave negative results during the same period. In order to obtain approval for its clinical use by the in-hospital ethical committee, relevant documents such as instructions for the preparation method, product information on safety usage and consent form were created. After these procedures, clinical applications of methylene blue injection were finally initiated.

Acute Disease↗
PubMedDate not supplied

'What have I done?': the issue of informed consent.

Patients are presented with informed consent forms at a time of stress and indecision. The patient should be treated with respect and not encouraged to sign a form that is not fully understood. Rehabilitation nurses whose patients face surgery are in a unique position to explore the implications of surgery with the patient. The nurse's role in assessing whether the patient is alert, knowledgeable of, and agreeable to all aspects regarding the surgery is vital.

Humans↗
PubMed2006

Patient acceptance of medical student participation in an outpatient obstetric/gynecologic clinic.

OBJECTIVE: To determine which patients, based on selected patient, physician and visit information, were more likely to accept medical student participation in an outpatient visit. STUDY DESIGN: A cross-sectional study conducted at a university-based private practice, evaluated 560 patients presenting for routine outpatient obstetric or gynecologic care. Participants completed a consent form regarding medical student participation in their visit. Patient, visit and physician demographic variables were abstracted. Comparison groups were those patients who accepted vs. those who refused medical student involvement. RESULTS: The majority of patients (75.8%) accepted student participation in their care. Patients who were black, were new to the office, were scheduled to see junior faculty and were evaluated for a vaginal discharge were more likely to refuse student participation. Patients seen for urinary incontinence were more likely to agree to medical student participation. CONCLUSION: The majority of patients consented to medical student involvement. Using a brief survey, we identified patients who are more likely to allow medical students to participate in their visit. We will continue to query all patients regarding medical student teaching but will assign medical students accordingly to maximize their learning experience. We will also educate patients on the benefits of including medical students in the outpatient visit.

Adult↗
PubMed2003

The medical responsibility: current view from the Council of Physicians side.

The medical responsibility has been clearly defined in the Royal Decree no. 78 dated November 11, 1967 concerning the medical practice. Moreover, several articles from the Ethical Code (Code de Déontologie) have clarified some social and economical responsibilities in the medical practice (articles 99 to 103) and the quality of patient care (article 36). The National Council has also published at least 31 advises facing the daily reality and the growing insecurity. That atmosphere is coming from the jurisprudence, the increasing responsibility insurance fees, the obligation of results instead of means, and the project of patient rights law. That project is currently dissociated from other projects such as an update on the medical responsibility and/or the no fault indemnity. Therefore, there is a current need for developing written patient information and using informed consent forms for risky surgical procedures. Before recognizing the no fault concept with indemnity, it is necessary to review the coverage of the responsibility insurance, educate the medical doctors in the no fault concept, study the mode of compensation for therapeutic hazards and differentiate the objective and subjective parts of the patient's chart.

Belgium↗
PubMed2004

Understanding of informed consent in a low-income setting: three case studies from the Kenyan Coast.

In our research unit on the Kenyan Coast, parents sign consent for over 4000 children to be involved in research activities every year. Children are recruited into studies ranging from purely observational research to the testing of new procedures and drugs. Thousands more community members consent verbally or in writing to the interviews and sometimes invasive procedures required in community-based research. Although every study and consent form is reviewed in advance by independent national and international committees, the views and understanding of the 'subjects' of these activities had not been documented before this study. In this paper, we focus on participant understanding of one field-based and two hospital-based studies, all of which involve blood sampling. The findings highlight a range of inter-related issues for consideration in the study setting and beyond, including conceptual and linguistic barriers to communicating effectively about research, the critical and complex role of communicators (fieldworkers and nurses) in consent procedures, features of research unit-community relations which impact on these processes, and the special sensitivity of certain issues such as blood sampling. These themes and emerging recommendations are expected to be relevant to, and would benefit from, experiences and insights of researchers working elsewhere.

Adult↗
PubMed1987

Abnormal findings in "normal" research volunteers.

We report three cases in which medical students who participated in clinical studies as normal volunteers were discovered, during the course of the research, to have potentially serious abnormalities. Their previously unsuspected conditions included chronic persistent hepatitis, a lesion in the cerebral cortex, and seropositivity for hepatitis B and HIV antibodies. These findings were surprising and distressing to both subject and investigator, and raised questions of the need for institutional guidelines, and the potential legal liability of the investigator. We discuss how improvements in Informed Consent Forms might aid in reducing these problems, by alerting the researcher and the subject to the possibility that unsuspected disease might be discovered during the course of a clinical research study.

Adult↗
PubMedDate not supplied

Behavior management conference panel III report-Legal issues associated with managing children's behavior in the dental office.

Panel III reviewed the legal issues associated with managing child behavior in the dental setting. The first issue addressed was a review of the recent changes in informed consent for behavior management techniques in pediatric dentistry. Discussions focused on: (1) who should obtain informed consent; (2) who can give informed consent; and (3) what constitutes appropriate documentation. Recent legal actions related to poor outcomes and poor communication using behavior management techniques were identified and discussed. Addressed was the current movement by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) towards empowering the child-patient to be a co-decision maker at all appointments and its impact on decisions in the dental office about approaches to behavior management. Finally, liability issues accompanying increased use of sedation in the dental office were identified and discussed. The recommendations of the panel were: (1) consideration should be given to changing the language in the current American Academy of Pediatric Dentistry (AAPD) guidelines, so written consent is not required for any procedure; (2) the AAPD should create language for use in creating sample consent forms (suggestive, not prescriptive); (3) guidelines recommending the possibility of treatment deferral, when appropriate, should be strengthened; and (4) the AAPD should work with advanced education program directors to standardize the quality and number of educational experiences in the use of conscious sedation.

Anesthesia, Dental↗
PubMedDate not supplied

Vocal ligametry. Update.

In 1983, a report was made concerning experience with a technique of vocal ligament tightening in certain cases of dysphonia due to the ligament's stretching or lengthening. Since that time, efforts to measure the relative slackness or loss of tension of the vocal ligament have been partially successful. This report addresses the topics of consent forms; review of the local board of human procedures; and technical problems of instrument design, fabrication, and calibration. A large data base will be needed before true usefulness can be derived from these efforts. The author hopes to stimulate other workers in the field of phonosurgery to parallel these efforts and explore a field that is still relatively uncharted.

Equipment Design↗
PubMedDate not supplied

Ongoing consent to care for older people in care homes.

Obtaining informed consent is a fundamental part of the care-giving process. Current policy documents emphasise the importance of including patients in planning their care. This article explores the concept of consent and the challenges to this concept for older people in long-term care, where consent is not a one-off event requiring a 'consent form', but just one stage in the continuum of involvement for service users. At one end of the spectrum, service users may be unaware that they have a service user plan (care plan), while at the other end they may be enabled to complete an advance statement of their wishes, thus demonstrating significant involvement in planning their care.

Advance Directives↗
PubMed1994

The effect of informed consent on the level of anxiety in patients given i.v. contrast material.

OBJECTIVE: A common reason given for not obtaining informed consent before the use of IV contrast material is that the anxiety created by informing patients of potential reactions will increase the possibility of their occurring. However, the idea that this is possible is debatable, and no study of this subject has used a standardized anxiety index. Accordingly, using the State-Trait Anxiety Inventory, we assessed the anxiety level among patients about to have an IV contrast procedure and measured the effect of informing them of the risks associated with the use of contrast material. SUBJECTS AND METHODS: Approximately 2050 adult outpatients at three separate medical centers were solicited for participation in this study. Each of the 1251 patients who volunteered to participate was placed into one of six groups. The majority were patients who were awaiting the injection of either ionic or nonionic contrast material and who were or were not informed of the risks associated with the use of IV contrast material. The last two groups were generally healthy outpatients reporting for routine X-rays who were not awaiting IV contrast administration but who were informed of the risks associated with the use of ionic and nonionic contrast material. Each patient informed of the risks was asked to read a standardized consent form, and all patients completed a standardized anxiety index. RESULTS: Patients who were informed of the risks associated with IV contrast material did not have measurably increased anxiety, and they did not have an increased prevalence of adverse reactions. Indeed, the only patients who had statistically significant increased anxiety compared with the other groups were among those awaiting the injection of ionic contrast material who were not informed of the risks (p = .04). The majority (51-78%) of patients in all six groups had measurable elevated anxiety scores. CONCLUSION: We conclude that it is not justified to fail to obtain informed consent in order to avoid anxiety-induced adverse reactions to IV contrast material. The majority of patients awaiting injection of IV contrast material have measurable increased anxiety levels regardless of whether they are informed of its risks.

Anxiety↗
PubMed2004

Implanon and medical indemnity: a case study of risk management using the Australian standard.

The contraceptive implant Implanon (Organon) was introduced in Australia in May 2001, and in the next 18 months was associated with an unprecedented number of adverse incident reports to medical indemnity insurers, including almost 100 unintended pregnancies. The medical indemnity insurer, MDA National, responded to this by applying the Australian and New Zealand Standard for Risk Management (AS/NZS 4360: 1999) in two stages. The first stage was to contain potential costs by moving the treatment into the general practice procedural category, resulting in a one-year moratorium on its use for most general practitioner members (prudential risk management). The second stage was to manage the clinical risk by developing strategies to reduce identified risks associated with the procedure. The Royal Australian College of General Practitioners (RACGP) was enlisted to develop guidelines for use of Implanon, with a consent form and checklists for doctors and patients, enabling MDA National to reinstate the treatment to the general practice non-procedural category. This case demonstrates the need for early risk assessment and development of risk-management tools for new treatments and devices, a role that is appropriate for the RACGP.

Australia↗
PubMed2000

Impact of technology choice on service provision for universal newborn hearing screening within a busy district hospital.

OBJECTIVE: To investigate the implications of technology choice between automated auditory brainstem response (AABR) and transiently evoked otoacoustic emissions (TEOAE) on service provision for a universal newborn hearing screening (UNHS) program. METHOD: Over a 4-day period, we offered to perform AABR hearing screening on a cohort of 48 well babies in the maternity unit and outpatient department of our busy district hospital. Those parents that consented were asked to sign a consent form and their babies were then screened using the Natus ALGO Model 2e color newborn hearing screener supplied on loan from Neonatal Perspectives Ltd, Manchester, UK. We recorded the patient age at testing, test duration, results obtained (as a pass/refer) and any problems that we experienced with the screening progress, together with parent or user perceived differences between this technology and the current TEOAE screen. A single user carried out all screening. Having collected the AABR data, we then analyzed the implications of the results in relation to service provision in our hospital, utilizing historical data on TEOAE screening. RESULTS: Forty-four mothers, from 48, consented to having their baby screened by AABR and we were able to achieve a result in all 44 babies that we screened. At the standard test criteria of 35 dBnHL, a total 42 babies passed the initial screen in both ears and 2 referred in a single ear only. The test duration was less than 5 minutes for 36 of 44 babies. Applying these results to a model of UNHS generated a per screen cost of 15.98 Pounds for a two-stage OAE/AABR program and 14.25 Pounds for an AABR-only program. Parents found the AABR test acceptable and we found that being able to discuss the screen and hearing with the parents while the screen was taking place both time-efficient and reassuring to parents. In our experience and using our screening model, the OAE/AABR two-stage approach would have generated 509 infants for second-stage screening (AABR stage) before full audiological follow up and the AABR-only approach would have generated 72 infants for second stage. CONCLUSIONS: Testing with the Natus ALGO Model 2e color newborn hearing screener proved to be practical, time-, and cost-efficient. The low initial referral rate would not only save money within our hospital, but serves to keep parental anxiety at a minimum. The high tolerance of ambient noise allowed flexibility in our screening location and timing, improving our ability to screen before discharge. In our setting, the adoption of AABR as our primary screen is more practical and less expensive than TEOAE.

Adult↗
PubMed1989

Interpretation and communication of the results of medical field investigations.

Since the controversy over cytogenetic test results at the Love Canal in New York State, there has been increasing concern about the communication of medical test results to participants in field studies. To identify the range of issues that arise and to present examples of practices that might be useful for consideration, we have drawn from 15 years of experience in interpreting and communicating the results of medical field investigations by the National Institute for Occupational Safety and Health. The investigations were qualitatively characterized according to study type and design, substances involved, language used in the notification of results, and the nature of the efforts to put results in perspective. Based on this evaluation, the following recommendations are made: (1) provide a comprehensible consent form, (2) interpret results for study participants, (3) use clear language, (4) be explicit about uncertainty of findings, (5) where appropriate, indicate the need for medical follow-up, (6) provide results promptly, (7) provide overall study results, (8) evaluate the impact of the notification, (9) train investigators in the practice of communicating results.

Environmental Exposure↗
PubMed2000

Adapting informed consent to contemporary managed care.

Patients' autonomy and rights have become inalienable values in most western countries. The instrument by which de facto patient autonomy in the healthcare system is practiced is the "informed consent" form. Despite the unquestionable importance of this tool, there are numerous inadequacies in this practice. One of the reasons is due to the fact that the physicians' autonomy to offer their patients the best care available has undergone considerable diminution due to financial considerations in the managed care environment. The healthcare system is a multifaceted one, made up of many agents and interested parties who lay down the laws and make the rules of the game. A physician-patient encounter does not take place in a void, and physicians are far less free to act than they have ever been before. This diminished independence is particularly felt in the milieu of managed care and has led to informed consent taking on a new and much greater significance when there are patient-"unfriendly" agendas.

Ethics, Medical↗