Evaluation of informed consent in health research: a questionnaire survey

Scand J Caring Sci; 2010; 24; 56–64
Evaluation of informed consent in health research: a questionnaire survey Objective: Informed consent is ethically and legally required for all biomedical and health research involving human participants. This study analyses the realization of informed consent in health research from the point of view of healthy, voluntary adult participants. Empirical studies from this point of view are still rare. Design: A population‐based questionnaire survey. Participants:  The study population consisted of 1410 men and women aged 57–78 years who are participants in a randomized controlled intervention trial on the effects of physical exercise and diet at Kuopio Research Institute of Exercise Medicine (eastern Finland). Methods:  The data were collected in 2005–2007 using a questionnaire. The questionnaire was given to all able and willing participants (n = 1324) who were still involved in the exercise and diet study at the 3‐month intervention visit. The response rate was 91%. Results: The defined key elements of informed consent were information, understanding, competence, voluntariness and decision‐making. A majority of the participants estimated that these key elements were successfully realized in the exercise and diet intervention study. Conclusions: Despite the general satisfaction with the informed consent process in the exercise and diet intervention study, a minority of the participants were dissatisfied with the information they had received or did not understand this information completely. These findings highlight the essential question: Did all of the participants truly give their genuine informed consent? This carefully executed study reveals objectively the difficulties in distribution of information to healthy adult volunteers.     

Impact of detailed informed consent on research subjects' participation: a prospective, randomized trial

This study was undertaken to measure potential research subjects' participation in a survey research design, based on level and type of informed consent required before enrollment. In this prospective, randomized trial, 300 eligible Emergency Department participants were randomized to one of three groups: verbal consent (n = 100), limited written consent (n = 100), and detailed written consent with signature (n = 100). The consent was related to a self-administered patient satisfaction survey. The primary outcome was level of participation, where participation was categorized as full, limited, or refusal. Ninety-five percent confidence intervals (CI) constructed about proportions were used to assess differences in participation rates between the three consent groups. Among 300 participants, no demographic differences were found between groups for age or gender. Participants who were randomized to complete the detailed written consent had a significantly lower rate of full participation (72%) when compared to those randomized to verbal consent (85%; mean difference between groups 13%, 95% CI 2% to 24%) and to those with limited written consent (84%; mean difference between groups 12%, 95% CI 1% to 23%). Participants randomized to detailed written consent also had a significantly higher refusal rate (23%) when compared to those in the limited written group (12%; mean difference between groups -11%, 95% CI -21% to -1%). The length and type of informed consent required affected potential research subject participation in a survey research design. Participants who were asked to sign a detailed written informed consent document had a lower rate of participation compared to those with verbal or limited written consent.     

Improvement of the comprehension of written information given to healthy volunteers in biomedical research: a single-blind randomized controlled study

Writing an informed consent form (ICF) for biomedical research is a difficult task. We conducted a multicenter single-blind randomized controlled trial to identify whether a working group or the systematic improvement in lexico-syntactic readability or an association of the two could increase the comprehension of the written information given to healthy volunteers enrolled in biomedical research. Participants were randomized to read one of four versions of the ICF: unchanged ICF (A), ICF with systematic lexico-syntactic readability improvement (B), ICF modified by a working group (C), and ICF modified by the working group followed by systematic lexico-syntactic improvement (D). The primary end-point was the objective comprehension score at day 0 for each study group. The scores of objective comprehension at day 0 were statistically different between the four study groups (anovaP = 0.020). The pairwise analysis showed an improvement in the working group vs. the unchanged group (P = 0.003), and a tendency to improvement in the group who read the ICF modified using lexico-syntactic readability and in the group who read the ICF modified using the two methods (P = 0.020 and 0.027 respectively). We conducted a two-way anova to identify some characteristics of the population which could explain this score. There was a significant interaction between the type of informed consent document (ICD) and the gender. Improving the ICD in phase I biomedical research leads to better comprehension, whether the method used is systematic lexico-syntactic improvement or a review by a working group. The improvement is specifically observed in men compared with women. Conversely, while both methods diverge in their effect on lexico-syntactic readability, their association is not mandatory. We suggest that in all phase I clinical trials, the ICF be improved by either method.     

新生儿科知情谈话记录单的设计与应用

目的应用知情谈话记录单,降低医患纠纷的发生率并提供法律依据。方法将患儿住院期间的病情、治疗护理方案、治疗费用、检查结果等真实情况告知患儿父母并在知情谈话记录单上签名。结果患儿父母对医护工作满意度由95．07％上升至99．13％,投诉率由2．61％下降至0．58％。结论知情谈话记录单的应用有利于提高患儿父母的满意度,减少医患纠纷。     

The subjective incremental cost of informed consent and documentation in hospital care: a multicentre questionnaire survey in Japan

Objective  To reveal the amount of time and financial cost required to obtain informed consent and to preserve documentation.
Methods  The questionnaire was delivered to all staff in six acute care public hospitals in Japan. We examined health care staff perceptions of the time they spent obtaining informed consent and documenting information. All data were collected in 2006 and estimates in the past week in 2006 were compared to estimates of time spent in a week in 1999. We also calculated the economic costs of incremental amounts of time spent in these procedures.
Results  In 2006, health care staff took about 3.89 hours [95% Confidence Interval (CI) 3.71–4.07] per week to obtain informed consent and 6.64 hours (95% CI 6.40–6.88) per week to write documentation on average. Between 1999 and 2006, the average amount of time for conducting informed consent was increased to 0.67 ( P  < 0.001) hours per person-week, and the average amount of time for documentation was increased to 0.70 ( P  < 0.001) hours per person-week. The annual economic cost of activities for informed consent and documentation in a 100-bed hospital increased from 117 755 to 449 402 US dollars.
Conclusions  We found a considerable increase in time spent on informed consent and documentation, and associated cost over a 7-year time period. Although greater attention to the informed consent process should be paid to ensure the notions of patient autonomy and self-determination, the increased resources devoted to these practices must be considered in light of current cost containment policies.     

知情同意在护理实践中存在的问题与对策

为减少和避免知情同意在护理实践中的矛盾，笔者分析了知情同意在护理实践过程中出现的问题：知情同意与医疗保护的矛盾；与医患双方医疗知识不平等的矛盾；与正常医疗护理行为不一致的矛盾；告知病人知情权时医与医、医与护不一致。并针对问题提出相应对策：增强法律知识学习；处理好知情权与医疗保护；与患者沟通的过程中用简洁明了、浅显易懂的语言描述问题；尊重病人的自主权；维护病人知情权中的医护一致性。     

Construction of a medication dependence questionnaire in headache patients (MDQ-H) validation of the French version

OBJECTIVES: To construct and validate a questionnaire measuring dependence on analgesics and on migraine attack treatments in headache patients. METHOD: The items were obtained using the Diagnostic and Statistic Manual of Mental Disorders (4th ed.) (DSM-IV) diagnostic criteria for dependence. The construct validity of the scale was investigated by confirmatory analysis in a sample of 156 patients. Regression analysis was used to explore predictive validity. RESULTS: The 21 items of the scale were grouped into seven first-order factors corresponding to seven dependence items described in the DSM-IV. There was a second-order factor that may be considered as a general dependence factor. The global questionnaire score predicted the number of units of treatment taken per week, the number of days of headache, the number of days medications were taken, and emotional distress. Patients with headache associated with chronic substance use had a significantly higher score (P < .000) than migraine and tension headache patients. CONCLUSION: It is a practical and valid tool for measuring medication dependence, including the behavioral dimension of dependence, in patients with headache associated with chronic substance use. It can prevent patients and clinicians from only focusing on pharmacological dependence.     

Communication and informed consent in phase 1 trials: a review of the literature

Phase 1 (P1) trials are vital to the development of cancer treatments; however, the patients involved in these trials are unlikely to receive any therapeutic benefit, and there are significant possibilities that they will experience serious side effects. Ethical requirements stipulate that patients must be adequately informed before they consent to participate in P1 trials. This review focuses on studies that have measured patient comprehension of information given during the informed consent process of P1 cancer trials. Patients consenting to participate in P1 trials currently have a limited understanding of trial purpose, an unrealistic expectation of the benefits and risks associated with trial participation and a questionable appreciation of their right to abstain or withdraw. Health care professionals recruiting to P1 trials need clear and practical guidelines and training packages designed to ensure that all details of P1 trials are communicated effectively to eligible patients.     

Screening for migraine in the general population: validation of a simple questionnaire

We present validation of a simple questionnaire designed to screen the general population for migraine. It comprises four questions: (1) "Have you ever had migraine?" (2) "Have you ever had severe headache accompanied by nausea?" (3) "Have you ever had severe headache accompanied by hypersensitivity to sound and light?" (4) "Have you ever had visual disturbances lasting 5-60 min followed by headache?" A telephone interview carried out by a physician was used as an index of validity. The study population was 5,360 twins from the population-based Danish Twin Registry. All twin pairs where at least one twin had answered "yes" to at least one of our questions were eligible for the telephone interview ( n =2,272 twins). The response rate to the questionnaire was 87%; the participation rate in the telephone interview was 90%. The questionnaire ascertained 85% of all migraineurs (sensitivity). A combination of two questions (questions 1 and 4) extracted 93% of the twins with migraine with aura and 74% of the twins with migraine without aura, yet only 26% of the sample needed to be interviewed. We conclude that in the Danish population two simple questions are sufficient to screen for migraine in selecting participants for a diagnostic clinical interview. Our questionnaire clearly merits further study to document its universal applicability.     

Development and validation of a questionnaire to self-assess the quality of interprofessional team meetings in primary and community healthcare

ABSTRACT

In the context of a quality assurance policy, a regional network initiated a project to measure the quality of interprofessional consultation meetings. A questionnaire was evaluated on content validity by 48 stakeholders: healthcare professionals, representatives from healthcare organizations, interprofessional consultation meeting coordinators, and representatives from patient organizations. A revision resulted in two subscales (each consisting of 16 items) for assessing process and outcome aspects of interprofessional consultation meetings. After validating the instrument, it was used in a hands-on test by individuals and in a pilot series of team-based self-assessments. Responses were used to analyse reliability and consistency of the subscales and the items, and to reveal first indications of relative weaknesses and strengths in interprofessional consultation meetings. Results point out that the subscales, now part of the Interprofessional Practice and Education Quality Scales (IPEQS), can be useful for self-assessment of the quality of such meetings in primary and community healthcare, but maybe also in other areas of interprofessional collaboration.     

Validation of a questionnaire to evaluate the quality of life of nonprofessional caregivers of dependent persons

AIM OF THE STUDY: To determine the acceptance, validity and reliability of the questionnaire for assessing the type of informal care that caregivers of dependent people give and the effects this care might have on the health of the carer. BACKGROUND: In Spain, the formal health care system provides 12% of the total time dedicated to health care, the remaining 88% is carried out by the informal system within the home environment. The act of caring has effects on various areas of the life of the carer and on family functioning. This makes clear the existing risk when the principal carer becomes a secondary nurse. METHODS: This research was a cross-sectional design, carried out in municipalities in the province of Barcelona (Spain) from January to December 1997. The subjects of the study were 240 caregivers of dependent people. The questionnaire (ICUB97Copyright ) is based on the Virginia Henderson's 14 Needs nursing model. The validity of the content was assessed through the consensus of a group of experts, validity of design by means of comparison with the hypotheses. RESULTS: Test-retest reliability was completed for the three parts of the questionnaire and the kappa index values was 0.89, 0.80 and 0.75 for each part. The higher the level of dependency of the person cared for, the more care tasks the carer had to perform. A correlation coefficient of 0.58 was obtained for the Barthel Index (P < 0.001) and 0.53 on the Philadelphia Index (P < 0.001). The care tasks performed by the carer showing greatest correlation with dependency level were; help with elimination (r=0.73, P < 0.001), help with feeding (r=0.55, P < 0.001) and help in personal development (r=0.55, P=0.001). CONCLUSIONS: This questionnaire provides a reliable and valid instrument for measuring the care given by caregivers to dependent people, to meet their basic needs as well as for assessing the needs of the carers who experience problems by the act of caring. It is therefore important for nursing practice, to have a validated instrument available for identifying the tasks performed by family carers and the effects on their health.     

手术知情同意签字对胆囊切除患者术前焦虑和术后康复的影响

背景知情同意签字是中国在外科手术前严格执行的一项制度,但其对患者心理和生理的影响目前尚不清楚.目的探讨手术知情同意签字对胆囊切除患者术前焦虑及术后恢复的影响.设计分组对照试验.地点和对象实验对象共68例,均为深圳市第二人民医院普外科住院行择期胆囊切除的患者,年龄32～58岁.干预68例胆囊切除手术患者随机分实验组35例和对照组33例.实验组由患者参加术前谈话并亲自签署手术同意书,对照组患者不参加术前谈话,由家属参加并签署手术同意书.主要观察指标测定手术知情同意签字前后患者的血压、心率、焦虑程度以及术后身体恢复的有关各项指标.结果实验组在手术同意签字后患者的收缩血压、心率、焦虑程度和术后疼痛均高于对照组(P＜0 05),术后首次下床活动时间和首次肛门排气时间推迟(P＜0.05).结论手术知情同意签字能使胆囊切除患者的焦虑程度增加,不利于术后身体的恢复.应重视知情同意签字对患者造成的心理压力,加强围手术期患者的心理干预和宣传教育.     

The Portuguese version of the musculoskeletal pain intensity and interference questionnaire for musicians (MPIIQM-Pt): Translation,cultural adaptation,and multicenter validation study in professional orchestra musicians

Objectives

We aim to assess the validity and reliability of the Musculoskeletal Pain Intensity and Interference Questionnaire for Musicians (MPIIQM) and to add to its cross-cultural adaptation process by translating, culturally adapting, and validating the MPIIQM into European Portuguese language in the population of Portuguese musicians.

Methods

A Portuguese version of the MPIIQM (MPIIQM-Pt) was created through a process of forward and back translation, pilot testing, and cultural adaptation by expert panel evaluation. The psychometric evaluation was performed in a validation sample of 134 musicians, at baseline and after 7 days.

Results

The high degree of internal consistency and the substantial test–retest reliability coefficients were demonstrated for each subscale (α = 0.896 and ICC = 0.997 for “pain intensity,” and α = 0.879 and ICC = 0.999 for “pain interference,” respectively). Exploratory factor analysis indicated two-factor structure (pain intensity and interference) that explained 75.5% of the variance. Both convergent and divergent validity are well demonstrated, confirming more than 90% of the previously defined hypotheses regarding correlations with other measures.

Discussion

MPIIQM-Pt is the first validated questionnaire to evaluate pain among Portuguese musicians. It showed excellent psychometric properties, both in terms of internal consistency, test–retest reliability, factor analysis, and construct validity. Therefore, it is a valid and reliable tool suitable for both research and clinical practice purposes. MPIIQM-Pt will allow the development of more robust studies on pain among musicians and the improved assessment and monitoring of pain in this population, filling an important gap in this field of Pain Medicine.     

Description and validation of an Italian ICHD-II-based questionnaire for use in epidemiological research

Background.— In the absence of biological markers, the diagnosis of primary headache in epidemiological studies rests on clinical findings, as reported through ad‐hoc interviews. Objectives.— The aim of this study was to validate a specially designed headache questionnaire to be administered by a physician for the diagnosis of primary headaches or of probable medication overuse headache in the general population according to the 2004 International Classification of Headache Disorders, 2nd edition (ICHD‐II). Methods.— The questionnaire comprises 76 questions based on the ICHD‐II diagnostic criteria for migraine (codes 1.1, 1.2.1, 1.2.2, 1.2.3, 1.5.1, and 1.6), tension‐type headache (codes 2.1, 2.2, 2.3, and 2.4), primary stabbing headache (code 4.1), and probable medication‐overuse headache (code 8.2.7), as well as on other clinical features (eg, age at onset, relation between headache and pregnancy, etc). The answers to each question could be of the following types: (1) numbers (ie, age at onset); (2) “Yes” or “No” (eg, as in reply to “Do you have nausea during headache?”); and (3) predefined answers (eg, quality of pain). We assessed the validity and reliability of the questionnaire and its sensitivity and specificity for migraine and tension‐type headache. Results.— The study population consisted of 50 patients (37 women and 13 men) aged 18‐76 years (mean, 40.7) seen for the first time on a consecutive basis at the University of Parma Headache Centre. The questionnaire was administered independently by 2 trained physicians (E1 and E2) prior to the visit performed by a headache specialist taken as the gold standard (GS). GS, E1, and E2 were blind to the diagnosis made by each others. If appropriate, more than 1 headache type were considered. When present, we defined the 2 different headache types in the same subject as Diagnosis 1 and Diagnosis 2. Questionnaire‐based diagnosis was compared with the diagnosis established by GS. For Diagnosis 1 (n = 50), we found an agreement rate of 98% (K‐value: 0.96; 95% confidence interval [CI]: 0.88‐1.00) between E1 and GS and between E2 and GS, and of 96% (K‐value: 0.91; 95% CI: 0.80‐1.00) between E1 and E2. For Diagnosis 2 (n = 24), we found an agreement rate of 83.3% (K‐value: 0.80; 95% CI: 0.63‐0.98) between E1 and GS, of 62.5% (K‐value: 0.62; 95% CI: 0.41‐0.82) between E2 and GS, and of 70.8% (K‐value: 0.66; 95% CI: 0.45‐0.87) between E1 and E2. Sensitivity and specificity were 100% and 93.3%, respectively, for migraine without aura (code 1.1) and 100% for frequent episodic tension‐type headache (code 2.2). Conclusion.— Our findings support the use of this questionnaire as a valid and reliable tool for diagnosis of headaches in epidemiological studies.     

抑郁症发作期患者就诊与住院知情同意状况的调查与分析

目的探讨抑郁症发作期患者就诊与住院知情同意状况,寻找既方便患者就诊和住院,又可避免因患者知情同意问题引起医疗纠纷的方法。方法对符合CCMD-3的抑郁发作期患者进行知情同意状况调查。结果患者对就诊知情者87例(52.41%),不知情者79例(47.59%);同意就诊者70例(42.17%),不同意就诊者96例(57.83%)。患者对住院知情者65例(39.16%),不知情者101例(60.84%);同意住院者53例(31.93%),不同意住院者113例(68.07%)。结论保证监护人对患者就诊和住院治疗的知情同意权是减少医疗纠纷的关键。     

Healthy participants in phase I clinical trials: the quality of their decision to take part

Aims and objective. This study was set out to test the quality of the decision‐making process of healthy volunteers in clinical trials. Background. Researchers fear that the decision to volunteer for clinical trials is taken inadequately and that the signature on the consent forms, meant to affirm that consent was ‘informed’, is actually insubstantial. Design. The study design was quasi‐experimental, using a convenience quota sample. Methods. Over a period of a year, candidates were approached during their screening process for a proposed clinical trial, after concluding the required ‘Informed Consent’ procedure. In all, 100 participants in phase I trials filled out questionnaires based ultimately on the Janis and Mann model of vigilant information processing, during their stay in the research centre. Results. Only 35% of the participants reached a ‘quality decision’. There is a definite correlation between information processing and quality decision‐making. However, many of the healthy research volunteers (58%) do not seek out information nor check alternatives before making a decision. Conclusions. Full disclosure is essential to a valid informed consent procedure but not sufficient; emphasis must be put on having the information understood and assimilated. Research nurses play a central role in achieving this objective.     

Chinese cross-cultural adaptation and validation of the Foot Function Index as tool to measure patients with foot and ankle functional limitations

Purpose: To perform a cross-cultural adaptation and validation of the Foot Function Index (FFI) questionnaire to develop the Chinese version.

Materials and methods: Three hundred and six patients with foot and ankle neuromusculoskeletal diseases participated in this observational study. Construct validity, internal consistency and criterion validity were calculated for the FFI Chinese version after the translation and transcultural adaptation process.

Results: Internal consistency ranged from 0.996 to 0.998. Test–retest analysis ranged from 0.985 to 0.994; minimal detectable change 90: 2.270; standard error of measurement: 0.973. Load distribution of the three factors had an eigenvalue greater than 1. Chi-square value was 9738.14 (p?r?=??0.634 (Factor 2) and r?=??0.191 (Factor 1). Foot Function Index (Taiwan Version), Short-Form 12 (Version 2) and EuroQol-5D were used for criterion validity. Factors 1 and 2 showed significant correlation with 15/16 and 14/16 scales and subscales, respectively.

Conclusions: Foot Function Index Chinese version psychometric characteristics were good to excellent. Chinese researchers and clinicians may use this tool for foot and ankle assessment and monitoring.

• Implications for rehabilitation

• A cross-cultural adaptation of the FFI has been done from original version to Chinese.

• Consistent results and satisfactory psychometric properties of the Foot Function Index Chinese version have been reported.

• For Chinese speaking researcher and clinician FFI-Ch could be used as a tool to assess patients with foot disease.