How informed is patients' consent to release of medical information to insurance companies?

A study was conducted to assess how informed the consent of patients is to the release of confidential information to insurance companies. Questionnaires were sent to 226 consecutive patients from four practices whose general practitioners had received requests to complete a personal medical attendant''s report for an insurance company. In total 195 patients returned the questionnaire, whose six questions required only a yes or no answer. More than half of the patients (102 (52%] could not recall having given their consent and 79 (40%) had one or more objections to the questions commonly asked by insurance companies. Questions about sexually transmitted diseases and AIDS led to the greatest proportion of objections (85% (67/79) and 80% (63/79) respectively). Over half (111 (57%) of the 195 respondents expected their doctor to withhold sensitive information. Of the 93 patients who gave their informed consent, 63 (68%) did not expect that their doctor would be asked to answer one or more of the common questions. In most cases the consent of patients to the release of confidential information to insurance companies is neither knowingly given nor informed.     

A multimedia tool for the informed consent of patients prior to gastric banding

Objective: Severe obesity is a clear indication for appropriate, effective weight loss therapy. One option is operative intervention, e.g., gastric banding. Risks of the operation and therapeutic alternatives need to be comprehensibly presented to the patient. The literature has shown that better informed consent is obtained using information presented in a multimedia/video‐based format. The current study developed and evaluated a multimedia program aimed at obtaining informed consent from obese patients before gastric banding. Research Methods and Procedure: An interactive multimedia program was developed with information about preoperative examinations, the operation itself, hospital stay, operative risks, alternative therapies, and the pathophysiology and health risks of obesity. Two groups (Group 1, n = 20, mean age 38 years, informed consent attained with conventional document information; Group 2, n = 20, mean age 37 years, informed consent attained with additional multimedia information) were interviewed regarding comprehensibility of the information presented, personal satisfaction, and anxiety levels during the informed consent process. Results: Group 2 showed significantly better (p < 0.05) understanding of the presented information and higher levels of satisfaction with the informed consent process. Anxiety levels did not significantly differ between the two groups. Discussion: Because patient satisfaction with the informed consent process and understanding of the presented information significantly improved, the multimedia program clearly benefits both surgeons and patients. Personal contact from the surgeon remains essential. High volumes of information presented in multimedia format do not alleviate patient anxiety, and personal contact may be beneficial.     

Longitudinal Study of Informed Consent in Innovative Therapy Research: Experience and Provisional Recommendations from a Multicenter Trial of Intracerebral Grafting

BackgroundThere is an urgent need to assess and improve the consent process in clinical trials of innovative therapies for neurodegenerative disorders.MethodsWe performed a longitudinal study of the consent of Huntington’s disease patients during the Multicenter Fetal Cell Intracerebral Grafting Trial in Huntington’s Disease (MIG-HD) in France and Belgium. Patients and their proxies completed a consent questionnaire at inclusion, before signing the consent form and after one year of follow-up, before randomization and transplantation. The questionnaire explored understanding of the protocol, satisfaction with the information delivered, reasons for participating in the trial and expectations regarding the transplant. Forty-six Huntington’s disease patients and 27 proxies completed the questionnaire at inclusion, and 27 Huntington’s disease patients and 16 proxies one year later.ResultsThe comprehension score was high and similar for Huntington’s disease patients and proxies at inclusion (72.6% vs 77.8%; P > 0.1) but only decreased in HD patients after one year. The information satisfaction score was high (73.5% vs 66.5%; P > 0.1) and correlated with understanding in both patients and proxies. The motivation and expectation profiles were similar in patients and proxies and remained unchanged after one year.ConclusionsCognitively impaired patients with Huntington’s disease were capable of consenting to participation in this trial. This consent procedure has presumably strengthened their understanding and should be proposed before signing the consent form in future gene or cell therapy trials for neurodegenerative disorders. Because of the potential cognitive decline, proxies should be designated as provisional surrogate decision-makers, even in competent patients.     

联合入路翻页式腹腔镜辅助右半结肠癌根治术与开腹根治术术后近期效果比较

摘要 目的：探讨联合入路翻页式腹腔镜辅助右半结肠癌根治术与开腹根治术术后近期效果比较。方法：选取2019年4月-2021年3月在南通大学附属肿瘤医院经CT和电子肠镜确诊的右伴结肠癌患者,所有患者均选择根治性右半结肠切除术（D2）。最后纳入研究对象77例,其中男性患者39例,女性患者38例,年龄37~75岁。根据手术方案将患者分为联合入路翻页式腹腔镜辅助手术40例,并命名为观察组,剩余37例行开放式根治术,为对照组。所有患者均提供了知情同意书。根据临床资料收集患者一般信息。记录围手术期结局为开腹手术或腹腔镜手术的手术时间,失血量,肛门排气时间,液体饮食时间,住院时间和30天之内的并发症和死亡率等。通过蛋白印迹分析患者术后7天血清内Polo样激酶（Polo-like Kinase 1,Plk1）、胸苷激酶1（Thymidine Kinase 1,TK1）、X连锁的凋亡蛋白抑制剂（X-linked inhibitor of apoptosis protein,XIAP）的活力。结果：两组患者一般资料比较无差异（P>0.05）。观察组较对照组的手术运行时间缩短,失血量减少,血管危险因素病发率降低（P<0.05）,淋巴结获得量两组比较无差异（P>0.05）。观察组较对照组的住院时间、第一次肛门排气时间、输液天数和胃肠功能恢复时间缩短（P<0.05）。观察组较对照组在吻合口漏、乳糜漏、术后腹腔出血和麻痹性肠梗阻等不良发生率比较无差异（P>0.05）,观察组较对照组的整体不良发生率升高（P<0.05）。观察组较对照组的Plk1、TK1、XIAP的蛋白表达降低（P<0.05）。结论：联合入路翻页式腹腔镜辅助右半结肠癌安全可行,且具有手术难度低,缩短手术时间,减少术中出血以及加快术后康复的优势。     

伴与不伴边缘性人格障碍的首发中青年抑郁症患者认知功能、临床症状的差异及其相关性分析

目的:比较伴与不伴有边缘性人格障碍(BPD)的首发中青年抑郁症患者认知功能及临床症状的差异,并分析相关性。方法:选取自2017年3月至2020年1月于我院就诊的首发中青年抑郁症患者167例,按照纳入标椎及排除标椎,剔除21例不符合者,最终入组146例。将伴有BPD的抑郁症患者归为研究组(72例),不伴有BPD的抑郁症患者归为对照组(74例)。采用韦氏记忆量表(WMS-RC)、韦氏智能量表(WAIS-RC)、威斯康星卡片分类测验(WCST)对两组患者进行认知功能的对照性评估,采用症状自评量表(SCL-90)评估患者临床症状,Pearson相关性分析患者认知功能与临床症状的关系。结果:研究组的人际关系敏感因子评分较对照组升高(P<0.05)。研究组即刻记忆、语言智商数、操作智商数评分均低于对照组,而持续错误数多于对照组(P<0.05)。经Pearson相关性分析可得:伴有BPD的首发中青年抑郁症患者人际关系敏感因子评分与即刻记忆、语言智商数、操作智商数均呈负相关关系(P<0.05),而与持续错误数呈正相关关系(P<0.05)。结论:伴有BPD的首发中青年抑郁症患者较不伴有BPD的抑郁症患者认知功能受损更为严重,人际关系敏感性更高,且患者的认知功能与临床症状存在一定的关联。     

Differentiating the Cognitive Profile of Schizophrenia from That of Alzheimer Disease and Depression in Late Life

Background

To compare the cognitive profile of older patients with schizophrenia to those with other neuropsychiatric disorders assessed in a hospital-based memory clinic.

Methods

Demographic, clinical, and cognitive data of all patients referred to the memory clinic at the Centre for Addiction and Mental Health between April 1, 2006 and August 15, 2008 were reviewed. We then identified four groups of older patients with: (1) late-life schizophrenia (LLS) and no dementia or depression (DEP); (2) Alzheimer''s disease (AD); (3) DEP and no dementia or LLS; (4) normal cognition (NC) and no DEP or LLS.

Results

The four groups did not differ in demographic data except that patients with AD were about 12 years older than those with LLS. However, they differed on cognitive tests even after controlling for age. Patients with LLS were impaired on most cognitive tests in comparison with patients with NC but not on recalling newly learned verbal information at a short delay. They experienced equivalent performance on learning new verbal information in comparison with patients with AD, but better performance on all other tests of memory, including the ability to recall newly learned verbal information. Finally, they were more impaired than patients with DEP in overall memory.

Conclusions

Patients with LLS have a different cognitive profile than patients with AD or DEP. Particularly, memory impairment in LLS seems to be more pronounced in learning than recall. These findings suggest that cognitive and psychosocial interventions designed to compensate for learning deficits may be beneficial in LLS.     

Occupational Attainment as a Marker of Cognitive Reserve in Multiple Sclerosis

Cognitive dysfunction affects half of MS patients. Although brain atrophy generally yields the most robust MRI correlations with cognition, significant variance in cognition between individual MS patients remains unexplained. Recently, markers of cognitive reserve such as premorbid intelligence have emerged as important predictors of neuropsychological performance in MS. In the present study, we aimed to extend the cognitive reserve construct by examining the potential contribution of occupational attainment to cognitive decline in MS patients. Brain atrophy, estimated premorbid IQ, and occupational attainment were assessed in 72 MS patients. The Minimal Assessment of Cognitive Functioning in MS was used to evaluate indices of information processing speed, memory, and executive function. Results showed that occupational attainment was a significant predictor of information processing speed, memory, and executive function in hierarchical linear regressions after accounting for brain atrophy and premorbid IQ. These data suggest that MS patients with low occupational attainment fare worse cognitively than those with high occupational attainment after controlling for brain atrophy and premorbid IQ. Occupation, like premorbid IQ, therefore may make an independent contribution to cognitive outcome in MS. Information regarding an individual''s occupation is easily acquired and may serve as a useful proxy for cognitive reserve in clinical settings.     

Bioethics for clinicians: 7. Truth telling

The standard of professional candour with patients has undergone a significant change over the past 30 years. Independent of their obligation to disclose information necessary for informed consent, physicians are increasingly expected to communicate important information to patients that is not immediately related to treatment decisions. The purpose of truth telling is not simply to enable patients to make informed choices about health care and other aspects of their lives but also to inform them about their situation. Truth telling fosters trust in the medical profession and rests on the respect owed to patients as persons. It also prevents harm, as patients who are uninformed about their situation may fail to get medical help when they should.     

Legal obligation of physicians to disclose information to patients.

Obtaining a patient''s consent is a routine daily process for physicians, although many are unaware of the scope of this legal obligation. In 1980 the Supreme Court of Canada changed the law relating to informed consent; promotion of patient autonomy shifted the focus from a standard of professional disclosure to one of a "reasonable patient." Physicians have a legal obligation to disclose to patients specific information, the scope of which is determined by a court on the basis of a reasonable patient''s expectation and the circumstances of the case. This gives rise to many controversies in the practice of clinical medicine. It is difficult for physicians to know which treatment risks require disclosure, since this is decided by a court in a retrospective analysis of the evidence. Will the court recognize exceptions to the duty of disclosing information? If several health care professionals are involved in a patient''s care who has the duty to disclose information? Can this duty be delegated? This paper provides physicians with guidelines that are consistent with the promotion of patient autonomy and comply with the doctrine of informed consent. In addition, it suggests ways of improving awareness of the doctrine and procedures to ease its application.     

Does informed consent influence therapeutic outcome? A clinical trial of the hypnotic activity of placebo in patients admitted to hospital.

To examine whether written informed consent might influence the results of clinical trials the effect of placebo when given with or without informed consent to patients suffering from insomnia was studied. The study was a single blind observer blinded trial, and patients were paired according to sex, age, and hospital environment. Randomisation assigned the first patient of each pair to the control group (without informed consent) or the group to give informed consent. Of the 56 patients, 26 refused to give informed consent, and the age and sex distribution of these differed significantly (p less than 0.02) from the 30 pairs of patients ultimately enrolled into the study. In this "biased" sample, the hypnotic activity of placebo was significantly higher in the control group (p less than 0.05). It is concluded that the informed consent procedure biases the results of clinical trials and might affect their general applicability.     

Communication of results of necropsies in north east Thames region.

OBJECTIVE--To evaluate the adequacy of reporting of results of necropsy to referring clinicians and to general practitioners. DESIGN--Questionnaire survey of referring clinicians and general practitioners of deceased patients in four districts in North East Thames region. Patients were selected by retrospective systematic sampling of 50 or more necropsy reports in each district. SETTING--One teaching hospital, one inner London district general hospital, and two outer London district general hospitals. PARTICIPANTS--70 consultants and 146 general practitioners who were asked about 214 necropsy reports; coroners'' reports were excluded. MAIN OUTCOME MEASURES--Time taken for dispatch of final reports after necropsy, consultants'' recognition of the reports, general practitioners'' recognition of the reports or of their findings, and consultants'' recall of having discussed the findings with relatives. RESULTS--Only two hospitals dispatched final reports including histological findings (mean time to dispatch 144 days and 22 days respectively). 42 (60%) consultants and 83 (57%) general practitioners responded to the survey. The percentage of reports seen by consultants varied from 37% (n = 13) to 87% (n = 36); in all, only 47% (39/83) of general practitioners had been informed of the findings by any method. Consultants could recall having discussed findings with only 42% (47/112) of relatives. CONCLUSIONS--Communication of results of necropsies to hospital clinicians, general practitioners, and relatives is currently inadequate in these hospitals. IMPLICATIONS AND ACTION--A report of the macroscopic findings should be dispatched immediately after necropsy to clinicians and general practitioners; relatives should routinely be invited to discuss the necroscopic findings. One department has already altered its practice.     

Recruitment to a prospective breast conservation trial: why are so few patients randomised?

OBJECTIVE--To investigate the rate of recruitment to early breast cancer trials and elucidate the reasons for ineligibility and refusal to participate among patients otherwise suitable for these trials. DESIGN--Prospective study of one year''s cohort of patients referred to a breast unit with special reference to the subgroup suitable for conservation management and to the proportion eligible for and (after informed consent) ultimately randomised within the Scottish early breast cancer trials. SETTING--The breast unit, Longmore Hospital, Edinburgh, during 1988. PATIENTS--All 3054 patients referred to the breast unit during the year. 324 Found to have invasive breast cancer and 147 initially thought suitable for conservation management. RESULTS--63 Patients were treated by mastectomy, 19 of whom requested mastectomy rather than conservation management. 84 Patients were excluded from trials, and of the 63 eligible patients, 40 gave informed consent. Most of the 23 patients who refused the trials requested a specific adjuvant treatment after discussion of their management and the trials. CONCLUSIONS--Recruitment to prospective trials in which informed consent is required before randomisation may be slower than predicted because of a high proportion of exclusions and also refusal by patients. Trials may therefore take longer to complete and give distorted results by virtue of the unpredictable nature of the selection of patients.     

Informed consent and nudging

In order to avoid patient abuse, under normal situations before performing a medical intervention on a patient, a physician must obtain informed consent from that patient, where to give genuine informed consent a patient must be competent, understand her condition, her options and their expected risks and benefits, and must expressly consent to one of those options. However, many patients refrain from the option that their physician believes to be best, and many physicians worry that their patients make irrational healthcare decisions, hindering their ability to provide efficient healthcare for their patients. Some philosophers have proposed a solution to this problem: they advocate that physicians nudge their patients to steer them towards their physician's preferred option. A nudge is any influence designed to predictably alter a person's behavior without limiting their options or giving them reasons to act. Proponents of nudging contend that nudges are consistent with obtaining informed consent. Here I argue that nudging is incompatible with genuine informed consent, as it violates a physician's obligation to tell their patients the truth, the whole truth, and nothing but the truth during adequate disclosure.     

Ownership and uses of human tissue: does the Nuffield bioethics report accord with opinion of surgical inpatients?

OBJECTIVE: To compare opinion of surgical inpatients with the conclusions of the report of the Nuffield Council on Bioethics regarding the ownership and uses of human tissue. DESIGN: Survey of results of questionnaires completed by patients. SETTING: Large teaching hospital. SUBJECTS: 384 postoperative adult surgical patients. RESULTS: There was strong support among patients for the use of tissues in medical education, research, and science with the exception of those tissues which may transmit disease to others. Few patients (39; 10%) believed that they retained ownership of tissue removed at surgery. Most believed that the tissue belonged to the hospital (103; 27%), to nobody (103; 27%), or to the laboratory (77; 20%). Most patients had not been given any information about the possible uses of their tissues after removal. CONCLUSIONS: Surgical inpatients seem to endorse the conclusions of the Nuffield report regarding the ownership and uses of human tissue. The recommendations regarding patient information and consent procedures should be implemented at the earliest opportunity.     

Randomised comparison of procedures for obtaining informed consent in clinical trials of treatment for cancer.

Methods of obtaining informed consent have evolved differently in Western countries without substantive information on the impact of these different practices on the patients. A randomised study was performed to compare two commonly adopted methods of seeking consent to randomised treatment: an individual approach at the discretion of each doctor and a uniform policy of total disclosure of all relevant information. The impact of both consent procedures on the patient''s understanding and anxiety levels and on the doctor-patient relationship was assessed by means of a questionnaire given soon after the consent interview. Fifty seven patients were assigned at random to two groups: to 29 patients an individual approach to seeking consent was adopted and to 28 patients all relevant information was given. Seven patients refused consent to randomised treatment, with slightly more refusals by patients in the total disclosure group (5 v 2, p = 0.25). The main effects of total disclosure of all information compared with an individual approach to seeking consent were: a better understanding of treatment and side effects and of research aspects of the treatments; less willingness to agree to randomised treatment; and increased anxiety. No significant differences were found in patients'' perceptions of the doctor-patient relationship. A repeat questionnaire given three to four weeks later no longer showed significant differences between the two groups.     

Informed Consent Prior to Coronary Angiography in a Real World Scenario: What Do Patients Remember?

Background

Patients'' informed consent is legally essential before elective invasive cardiac angiography (CA) and successive intervention can be done. It is unknown to what extent patients can remember previous detailed information given by a specially trained doctor in an optimal scenario as compared to standard care.

Methodology/Principal Findings

In this prospective cohort study 150 consecutive in-patients and 50 out-patients were included before elective CA was initiated. The informed consent was provided and documented in in-patients by trained and instructed physicians the day before CA. In contrast, out-patients received standard information by different not trained physicians, who did not know about this investigation. All patients had to sign a form stating that enough information had been given and all questions had been answered sufficiently. One hour before CA an assessment of the patients'' knowledge about CA was performed using a standard point-by-point questionnaire by another independent physician. The supplied information was composed of 12 potential complications, 3 general, 4 periprocedural and 4 procedural aspects.95% of the patients felt that they had been well and sufficiently informed. Less than half of the potential complications could be remembered by the patients and more patients could remember less serious than life-threatening complications (27.9±8.8% vs. 47.1±11.0%; p<0.001). Even obvious complications like local bleeding could not be remembered by 35% of in-patients and 36% of out-patients (p = 0.87). Surprisingly, there were only a few knowledge differences between in- and out-patients.

Conclusions

The knowledge about CA of patients is vague when they give their informed consent. Even structured information given by a specially trained physician did not increase this knowledge.     

How Are the Interests of Incapacitated Research Participants Protected through Legislation? An Italian Study on Legal Agency for Dementia Patients

Background

Patients with dementia may have limited capacity to give informed consent to participate in clinical research. One possible way to safeguard the patients'' interests in research is the involvement of a proxy in the recruitment process. In Italy, the system of proxy is determined by the courts. In this study we evaluate the timing for appointment of a legal proxy in Italy and identify predictive variables of appointment.

Methodology/Principal Findings

Subjects were recruited among the outpatients seeking medical advice for cognitive complaints at the Centre for Research and Treatment of Cognitive Dysfunctions, University of Milan, “Luigi Sacco” Hospital.The Centre was participating to the AdCare Study, a no-profit randomised clinical trial coordinated by the Italian National Institute of Health. The requirement that informed consent be given by a legal representative dramatically slowed down the recruitment process in AdCare, which was prematurely interrupted. The Centre for Research and Treatment of Cognitive Dysfunctions collected data on the timing required to appoint the legal representatives. Patients diagnosed with dementia and their caregivers were provided information on the Italian law on legal agency (law 6/2004). At each scheduled check-up the caregiver was asked whether she/he had applied to appoint a legal proxy for the patient and the time interval between the presentation of the law, the registration of the application at the law court chancellery and the sentence of appointment was registered. The study involved 169 demented patients. Seventy-eight patients (46.2%) applied to appoint a legal proxy. These subjects were usually younger, had been suffering from dementia for a longer time, had less than two children and made more use of memantine. The mean interval time between the presentation of the law and the patients'' application to the law court chancellery was two months. The mean interval time between the patient''s application to the law court chancellery and the sentence of appointment was four months.

Conclusions/Significance

In Italy the requirement that legal representatives be appointed by the courts slows down subjects'' participation in research. Other procedures for legal agency of the incapacitated patients may be adopted, taking as examples other EU countries'' systems.     

针灸联合多奈哌齐和美金刚对重度老年痴呆患者行为能力和认知功能的影响

目的:研究针灸联合多奈哌齐和美金刚对重度老年痴呆患者行为能力和认知功能的影响。方法:选择2015年1月～2018年12月在我院精神科进行诊治的50例重度老年痴呆患者,采用随机数字表法将其平均分为两组,每组25例。对照组患者口服多奈哌齐以及美金刚治疗,初始给药剂量均为每天口服5 mg,逐渐将给药剂量升高至每天口服20 mg,每次1片,每天2次。观察组患者采取针灸联合多奈哌齐和美金刚治疗,每天针灸治疗1次,每治疗6 d后休息1 d。两组患者均连续治疗4周。记录和比较两组患者治疗前后的日常生活能力与认知功能的变化情况。结果:观察组患者治疗4w后的治疗有效率为92.00%(23/25),明显高于对照组[68.00%(17/25)](P0.05);两组治疗4w后的MMSE和BI评分均显著高于治疗前(P0.05),且观察组以上指标均显著高于对照组(P0.05)。结论:针灸联合多奈哌齐和美金刚对重度老年痴呆患者的治疗效果明显优于单纯使用多奈哌齐和美金刚治疗,其可更有效改善患者的行为能力和认知功能。