Informed consent in clinical practice and medical research

The present paper deals with the basic aspects, influences and elements that constitute Informed Consent seeing it as a process and not only as an administrative format. Both the patient-physician relationship, as well as the research subject-investigator relationship, should be seen in the same manner, in spite of recognizing specific objectives for each one. For this reason, Informed Consent should not be different regarding both clinical as well as research activities. The patient-physician relationship presents a disbalance of power within the relationship in favor of the physician; this adds to the moral considerations that take place within both participants. Informed Consent should be defined in a broad sense as all those actions that promote a process of communication and dialogue which facilitates a person in order to make decisions with respect of an action, practice or product that have an impact on his/her body, intimacy or other vital spaces. Informed Consent has influences that originate in basic bioethical principles (autonomy, beneficience, non-maleficence, justice), professional and international declarations (Hippocratic Oath, Declaration of Helsinki), as well as legal considerations pertinent to each country. In our country legality emmanates from the General Health Law which, unfortunately, only contemplates Informed Consent as part of the relation established in clinical research. However, the Official Medican Norm on the Clinical Record establishes the conditions where Informed Consent must be obtained during clinical as well as research activities. Primary components of Informed Consent (revelation, capacity to understand and voluntariness), can be better understood when divided into several elements: information, voluntariness, risks and benefits, confidentiality, return of information, utility of the process and management of fragility. Informed Consent should be legally instrumented in an explicit written manner (administrative formats). However, it is important to recognize the limitations of these formats when used outside the context of a continuous communication process with the patient. For this reason, ultimate instrumentation is through continuous dialogue between patient and physician. Finally, Informed Consent might help improve the patient-physician relationship which, in the end, might be the best way to counteract the influence of the establishment of health management services.     

Learning ethics through everyday problems: informed consent

The teaching of bioethics and its importance in clinical relationships is to a certain extent complicated when we address students of medicine, young people who are more used to dealing with and solving strictly clinical problems. Informed Consent is one of the aspects of professional practice that is generally and widely accepted in Western societies, although difficulties are still encountered in explaining it from a purely theoretical model. This situation led us to design an educational strategy to make the Informed Consent concept more understandable.     

Research and the (free and) informed consent

The aim of this article was to reflect about the Free and Informed Consent (IC) in qualitative researches in the health field. Coming from the experience of being part of a CER (Committee for Ethic in Research) in the health area the authoresses place in debate some important questions, exploring them and conducting suggestions. One of these questions and topic of analysis is the meaning of IC, as for the participant as for the researcher.     

Bioethics and research into mental health

This article discusses research in the field of mental health, examining the ethical is sues involved and the use of Informed Consent. In order to achieve these objectives two main approaches were used: (1) a brief history of the different treatments and research with patients with mental illness or disability; (2) theoretical and conceptual analysis of the main problems concerning the mental health field, namely the notion of vulnerability, responsibility and autonomy and the use of placebo control groups. Two main questions prompted the reflection on whether the patient with a mental disorder can sign an Informed Consent, and whether the use of a placebo is acceptable. The existence of antagonistic and contradictory positions indicates that mental health research is hampered by biases that are difficult to overcome. Ethical investigation that may contribute to the healing of mental disorders should not however be overlooked merely because of the difficulties involved in its implementation. It must be borne in mind that changes occurring in the context of Psychiatric Reform in Brazil are gradually altering archaic concepts about what constitutes mental illness and how this group should be understood and treated.     

A randomized controlled trial comparing quantitative informed consent formats

Informed consent has been indirectly studied only in settings that do not replicate the actual consent process. We designed a sham study and randomly allocated adult ambulatory patients to receive one of two consent forms: Consent A (n = 52) described a randomized trial of usual treatment vs a new medication that "may work twice as fast as the usual treatment"; or Consent B (n = 48) that described a randomized trial of a new medication that "may work half as fast as the usual treatment". Patients randomized to Consent A were more likely to consent than those randomized to Consent B (consent rate A = 67%, consent rate B = 42%, p less than 0.01). Among patients who cited quantitative information, the difference in consent rate was even more marked (95% vs 36%, p less than 0.001); patients who did not cite quantitative information had equivalent consent rates. Patients who perceived minimal or severe symptoms had lower consent rates than those with mid-range symptom scores (chi 2(2) = 8.35, p = 0.015). Patients who recognize quantitative information will use it to make informed consent decisions.     

医疗知情同意书的完善与应用

医疗知情同意书是医疗法律文书 ,是卫生部《病历书写基本规范》的新要求。在提高认识和加深理解的基础上 ,完善了知情同意的系列文书并应用于临床 ,收到了良好效果。     

CT性能/质量检测中文文献的初步分析(Ⅰ)

目的:为CT性能/质量检测提供参考。方法:对1998年～2002年8月有关CT性能/质量检测的中文文献进行研究。结果:公布结果的文献汇总约有1/4CT检测不合格;一手机合格率高于二手机;部分文献项目、数据不全。结论:CT性能/质量检测是质量控制系统工程中重要的一环,还须严格执行并完善相关的制度及规章,使医患双方受益。     

1080份知情同意书填写缺陷分析

目的探讨病案中知情同意书填写存在的问题,并采取有效的改进措施,提高病案质量。方法分析我院2011年1～11月出院病案,对1 080份知情同意书填写情况进行统计分析。结果 1 080份知情同意书中,缺陷最多的是一般项目填写不全350例,占32.4%;其次是多次操作或治疗只签一次知情同意书150例,占13.9%。结论正确填写好每份知情同意书,提高医务人员对知情同意书的重要认识,是减少医疗纠纷的重要途径。     

Readability of informed consent documents used in the hospitals of Asturias

OBJECTIVE: To evaluate the readability of the informed consent documents (ICD) used in the health centers of Asturias (Spain) with the aim of verifying whether the ICD are understandable and sufficient as a vehicle of information to empower patients to participate in decisions related to their diagnosis and treatment. METHOD: A total of 1114 ICD were gathered from the health centers in Asturias. A representative random sample from each hospital was selected and the following readability indexes were obtained: the Flesch index, the sentence complexity index, and the integrated legibility index. RESULTS: Of the ICD in the sample studied, legibility was acceptable in 77.3% (221 out of 286) according to the integrated legibility index, in 75.2% (215 out of 286) according to the sentence complexity index and in 3.5% (10 out of 286) according to the Flesch index. The mean values of the indexes differed among hospitals (p < 0.001, ANOVA test). CONCLUSIONS: ICD written in Spanish achieved low readability scores in the Flesch index and require corrective measures. Three quarters of the ICD were acceptable due to the use of simple sentences in the text. We believe that readability indexes should be used when drafting or improving informed consent documents.     

Experience with CT colonography (virtual colonoscopy) from the view of gastroenterologists

Colonoscopy is a golden standard in the diagnostics of intraluminal diseases of the large intestine. Its advantage is the possibility of histological sampling (biopsy) and therapeutical interventions. In case of technical difficulties (stenosis, severe inflammation, diverticulosis, anatomical alterations) or lack of informed consent of the patient double contrast colonography is the routine diagnostic tool for the examination of the entire large intestine. The spread of the use of colon capsule as a novelty is keeping us waiting. A very important criteria is the adjudication of the expansion of the intestinal disease to the surrounding and distant organs. The correct diagnostics are the base of therapy planning. CT colonography as a standardizable imaging method can give information at once about the intraluminal aberrations, the spread to the surroundings and the abdominal status. The rapid, minimal invasive technology without sedation using multidetector CTs makes the method widely applicable. AIMS: The authors search for the locus of CT colonography in the diagnostics of non-malignant diseases of the large intestine, in the screening of colorectal carcinoma and during tumor staging. METHOD: Data of 92 males (mean age: 61.2+/-12.3 years) and 146 females (mean age 61.4+/-12.5 years) were collected after CT colonography had been performed at Zala County Hospital between September 2002 and January 2007. Indications, protocols and results determining further business have been reviewed. RESULTS: The reason of CT colonography was the failure of colonoscopy in 29% of the 238 patients. In 45/238 patients (19%) stricture of the colon, in 23/238 cases (10%) pain, lack of compliance and technical difficulties were the reasons of failure. In 60% of the remaining 23 persons organic intestinal diseases were diagnosed. In 151 cases (63%) the lack of informed consent for colonoscopy was the reason of radiological examinations, pathological aberrations were found in every second patient. Aiming to learn the method, CT colonography was performed after total colonoscopy in 19/238 patients after informed consent. CONCLUSIONS: CT colonography is a useful tool in the algorithm of diagnostics of colorectal diseases in the case of lack of performing total colonoscopy.     

'Informed consent' in public health activities: based on the universal declaration on bioethics and human rights, UNESCO

OBJECTIVES: The objective of this paper is to discuss the importance of obtaining informed consent for conducting epidemiological studies and public health activities, based on the Report of the UNESCO's Working Group on Informed Consent. METHODS: The Report of the UNESCO's Working Group on Informed Consent was reviewed and discussed in connection with the ethical considerations of public health activities and epidemiological research. RESULTS: It was at the Nuremberg Trial for the German war criminals of the Second World War that the principle of 'consent' was first stated as a consequence of the medical abuses carried out during the War. As a result of the Trial, the Nuremberg Code came out in 1947. Since then, various international declarations or ethical principles on 'informed consent' have been developed and published. These ethical principles on 'informed consent' have mostly to do with the clinical research that involves human subjects, and not with epidemiological studies and public health activities. However, UNESCO recently issued a comprehensive Report on Informed Consent based on the Universal Declaration on Bioethics and Human Rights adopted in 2005, and this included detailed guidelines on informed consent in epidemiological studies and public health activities. CONCLUSIONS: Universal Declaration on Bioethics and Human Rights emphasizes the principle of autonomy to protect the human rights of the human subjects involved in any public health activities and epidemiological research. As a practical guideline, obtaining informed consent is strongly recommended.     

The Ethics of Informed Consent

SUMMARY

Informed consent is a critical variable in the self-determination of consumers receiving health and mental health services. Consent has become a more stringent requirement in recent years. However, providers emphasize legal requirements rather than the true participation of consumers-the “spirit” of informed consent. This article discusses the elements of informed consent, the issues that reflect the “spirit” of consent, and recommendations for actions that foster self-determination in practice.     

Painting a truer picture of US socioeconomic and racial/ethnic health inequalities: the Public Health Disparities Geocoding Project

OBJECTIVES: We describe a method to facilitate routine monitoring of socioeconomic health disparities in the United States. METHODS: We analyzed geocoded public health surveillance data including events from birth to death (c. 1990) linked to 1990 census tract (CT) poverty data for Massachusetts and Rhode Island. RESULTS: For virtually all outcomes, risk increased with CT poverty, and when we adjusted for CT poverty racial/ethnic disparities were substantially reduced. For half the outcomes, more than 50% of cases would not have occurred if population rates equaled those of persons in the least impoverished CTs. In the early 1990s, persons in the least impoverished CT were the only group meeting Healthy People 2000 objectives a decade ahead. CONCLUSIONS: Geocoding and use of the CT poverty measure permit routine monitoring of US socioeconomic inequalities in health, using a common and accessible metric.     

Discordance between reported intention-to-treat and per protocol analyses

OBJECTIVE: To quantify the degree of disagreement between the two most popular methods for dealing with missing data: intention to treat (ITT) and per protocol (PP). STUDY DESIGN AND SETTING: We performed a systematic review of randomized two-armed clinical trials (CTs) published between 2001 and 2003, abstracted in PubMed and reporting both the ITT and PP analyses on a primary binary endpoint, out of which 74 papers were finally selected. The treatment effect of each CT was measured by the odds ratio, and the disagreement between them was quantified by the Bland-Altman method. RESULTS: On average, the PP estimator provides greater values Log(e)ORPP=1 x 25.Log(e)ORITT, (95% CI: 1.15, 1.35) than the corresponding ITT estimator, although the limits of concordance showed that the ratio between the two estimators varies greatly from 0.39 up to 2.53. CONCLUSION: These results confirm that missing values may cause both systematic and unpredictable bias in CTs. Further efforts should be made to minimize protocol deviations and to use better statistical methods to highlight the drawbacks of missing information. In the presence of protocol deviations, the conclusion of a CT cannot rest on the single reporting of either the ITT or the PP approach alone.     

早产儿颅内出血的头颅CT特点与临床表现分析

目的: 通过分析 337例早产儿头颅CT检查结果, 了解早产儿颅内出血 (intracranialhemorrhage, ICH) 的发病情况、头颅CT与临床表现特点。方法: 337例早产儿于生后 3~7d行头颅CT检查, 其中 98例存在ICH, 收集其临床资料, 分析出生体重、胎龄与ICH类型的关系, 分析ICH患儿临床表现特点与转归情况。结果: 98例ICH早产儿 (检出率 29 .1% ) 中有围产期因素者 69例 (70 .4% ); 出血类型: 蛛网膜下腔出血 (subarachnoidhemorrhage, SAH) 62例 (63 .3% ), 室管膜下-脑室内出血 (subependymal/intraventricularhemorrhage, SEH/IVH) 28例 (28. 6% ), 脑实质出血 (intraparenchymalhemorrhage, IPH)8例 (8. 2% ), 出生体重>1 500g、胎龄≥34周者多发生SAH, 出生体重<1. 000g、胎龄<32周者发生SHE/IVH较多; 临床表现: 有症状者 72例 (73. 5% ), 其中以兴奋症状为主者 16例, 以抑制状态为主者 48例, 先短暂兴奋后转为抑制状态者 8例; 转归: 治愈及好转 68例, 死亡 28例, 自动出院 2例, 病死率 28. 6%。结论: 早产儿ICH多数有围产期因素, 出血类型与出生体重、胎龄存在一定关系, 临床表现多样, 易漏诊, 病死率高, 故早产儿常规进行头颅CT检查是必要的。     

Cooling Towers contribute to the high seroprevalence of Legionella pneumophila antibody among hotel workers

Objectives

Regular disinfection work of the cooling towers (CTs) were carried out according to schedule, nevertheless 89.6% of the CTs were still found to be colonized by Legionella pneumophila in our survey in Changzhou city, China. The aim of the study was to observe the effect of L. pneumophila on workers exposed to contaminated cooling towers (CT).

Methods

A total of 364 subjects were randomly selected for the serum testing and the questionnaire survey. They were either from the hotel with contaminated CTs or without CTs (used as control). heir serum anti-L. pneumophila antibodies were tested using commercial IFA kits.

Results

The results showed that the prevalence of anti-L. pneumophila group 1 antibodies in the exposed population was significantly higher than control subjects (OR?=?2.845, P?=?0.019). The possible confounding factors were analyzed. Questionnaires results analysis found that the frequency of flu-like symptoms in the exposed group was also significantly higher; and the indoor air quality was related to the serum anti-L. pneumophila group 1.

Conclusions

The L. pneumophila contaminated CTs contribute to the high seroprevalence of anti-L. pneumophila antibodies; tap water and shower water are also possible contamination resources.     

A brief measure of perceived understanding of informed consent in a clinical trial was validated

BACKGROUND AND OBJECTIVE: To develop and evaluate an Informed Consent Questionnaire (ICQ) for measuring self-reported perceived understanding of informed consent in a randomized clinical trial. METHODS: The study was embedded in a Department of Veterans Affairs randomized clinical trial of Gulf War veterans' illnesses (CSP#470). The trial was initiated in May 1999 at 20 hospitals and concluded in September 2001; 1,092 participants were enrolled and followed for 12 months. The reliability and validity sample included 1,086 participants evaluated at baseline, 906 at 3 months, 929 at 6 months, and 910 at 12 months. The psychometric evaluations included tests of acceptability (based on missing data, endorsement frequencies, and floor/ceiling effects), item reduction, internal consistency, and construct validity (based on Cronbach's alpha coefficients, item-total correlations, and principal components analysis). RESULTS: The ICQ had >5% missing information on some questions at baseline, indicating poor acceptability prior to the initiation of the trial; however, the scale had good acceptability at each of the follow-up visits. Psychometric evaluation following standard item reduction techniques confirmed the reliability and validity of a four-item subscale of the ICQ (ICQ-4). CONCLUSIONS: The ICQ-4 is a simple and psychometrically sound self-report measure of perceived understanding of informed consent.