Improved pregnant women's understanding of research information by an enhanced informed consent form: a randomised controlled study nested in neonatal research.

OBJECTIVE: This study aimed to test the applicability and effectiveness of the enhanced informed consent form (ICF) methodology, proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER), in neonatal research requiring maternal consent. DESIGN: A single-centre open-label randomised controlled study. SETTING: Antenatal care clinics at Phramongkutklao Hospital, Thailand. PATIENTS: 234 pregnant women who were at risk of preterm labour were enrolled; 232 individuals completed the study. INTERVENTIONS: The participants were randomly assigned to read either the SIDCER ICF or the conventional ICF. MAIN OUTCOME MEASURES: The participants' understanding of essential trial-related information was assessed using 25 closed-ended questions. The primary endpoint was the proportion of the participants who obtained the satisfactory level of understanding at 80% (score of ≥20/25). RESULTS: 72.5% (87/120) of the participants in the SIDCER ICF group and 59.8% (67/112) of the conventional ICF group achieved the primary endpoint (relative risk (RR)=1.212, 95% CI 1.005 to 1.462, p=0.041). The superiority of the SIDCER ICF over the conventional ICF was significant, particularly among the participants whose education was at the high school level or below (63.5% vs 44.1%, RR=1.441, 95% CI 1.022 to 2.030, p=0.031). CONCLUSIONS: The SIDCER ICF methodology is applicable to neonatal research requiring maternal consent. The SIDCER ICF significantly improved the understanding of pregnant women, particularly among those with lower levels of education. The present study confirms the value of the SIDCER ICF methodology in research involving individuals with a limited academic background.

Informed consent and the readability of the written consent form.

Introduction The aim of this study was to objectively ascertain the level of readability of standardised consent forms for orthopaedic procedures. Methods Standardised consent forms (both in summary and detailed formats) endorsed by the British Orthopaedic Association (BOA) were retrieved from orthoconsent.com and assessed for readability. This involved using an online tool to calculate the validated Flesch reading ease score (FRES). This was compared with the FRES for the National Health Service (NHS) Consent Form 1. Data were analysed and interpreted according to the FRES grading table. Results The FRES for Consent Form 1 was 55.6, relating to the literacy expected of an A level student. The mean FRES for the BOA summary consent forms (n=27) was 63.6 (95% confidence interval [CI]: 61.2-66.0) while for the detailed consent forms (n=32), it was 68.9 (95% CI: 67.7-70.0). All BOA detailed forms scored >60, correlating to the literacy expected of a 13-15-year-old. The detailed forms had a higher FRES than the summary forms (p<0.001). Conclusions This study demonstrates that the BOA endorsed standardised consent forms are much easier to read and understand than the NHS Consent Form 1, with the detailed BOA forms being the easiest to read. Despite this, owing to varying literacy levels, a significant proportion of patients may struggle to give informed consent based on the written information provided to them.

[Informative Texts for Rehabilitation Patients are Difficult to Understand]. / Informationstexte für Rehabilitanden sind schwer verständlich.

OBJECTIVE: To check the intelligibility of informational texts written for rehabilitation patients. METHOD: Most investigated texts came from rehabilitation providers, patient organizations and health portals (8 texts), and from 50 rehabilitation facilities for musculoskeletal conditions (145 texts). We added a self-written booklet in plain language. All texts dealt with the goals and substance of rehabilitation. Readability formulas were computed for each text, and the Hamburg approach to intelligibility was applied. RESULTS: Only highly educated people will find the documents easily to understand, except for our self-written booklet, which is also comprehensible to lower secondary school leavers. CONCLUSION: The informational texts are of little help for people who are undecided whether or not to participate in rehabilitative measures and for rehab patients in preparatory stages. Issuing organizations are overburdened with the task of wording in a comprehensible manner, and should consider seeking assistance by professional writers or providing training for their staff.

Electronic processing of informed consents in a global pharmaceutical company environment.

We present an electronic capture tool to process informed consents, which are mandatory recorded when running a clinical trial. This tool aims at the extraction of information expressing the duration of the consent given by the patient to authorize the exploitation of biomarker-related information collected during clinical trials. The system integrates a language detection module (LDM) to route a document into the appropriate information extraction module (IEM). The IEM is based on language-specific sets of linguistic rules for the identification of relevant textual facts. The achieved accuracy of both the LDM and IEM is 99%. The architecture of the system is described in detail.

The contents and readability of informed consent forms for oncology clinical trials.

OBJECTIVES: To compare the quality of informed consent forms (ICF) for different trial phases, funding sources, oncology subspecialties, disease settings, and intervention modalities. METHODS: ICF for prospectively conducted clinical trials were examined for their descriptions of benefits and risks, study alternatives, voluntary participation, and confidentiality. Readability was assessed with Flesch Reading Ease (FRE) score and Flesch-Kincaid Reading Grade Level. RESULTS: Among 262 evaluable trials, ICF contained an average of 3982 words, 379 sentences, and 10.5 pages. The mean FRE score and Reading Grade Level were 61.2 and 7.4, respectively. All ICF explicitly stated that the intervention was investigational. Only 2 (1%) promised direct personal benefits, 16 (6%) suggested the chance of cure or prolonged survival, and 89 (34%) indicated a potential for tumor response. Conversely, 239 (91%) mentioned the risk of serious harms, 217 (83%) admitted that some side effects could be unknown or unpredictable, and 126 (48%) reported hospitalization or death as a possibility. Alternatives to participation, right to withdraw from study, and data confidentiality were addressed in 242 (92%), 254 (97%), and 260 (99%) ICF, respectively. Hematology, industry-funded, metastatic, and systemic therapy trials were most likely to highlight major risks (P < 0.05). Readability was better in phase I trials and in studies, which were performed by medical oncologists, sponsored by governmental agencies, conducted in the metastatic setting, and involved systemic therapy (P < 0.05). CONCLUSIONS: ICF had acceptable readability and provided a realistic overview of the benefits and risks of clinical trials, but the potential for hospitalization or fatality was underreported.

Orthognathic surgery: a new preoperative informed consent model.

The authors of this study propose a new informed consent form for orthognathic surgery. In a previous study from 2004, a careful review of the international literature and clinical practice suggested the feasibility of dividing the informed consent form into 2 parts, one describing diagnostic procedures and therapeutic/surgical times, and another describing possible problems. During these 4 years, we noticed that this model has 2 setbacks. We replaced point 2, "temporomandibular joint disorders," with "postoperative temporomandibular joint derangement," so that the surgeon is now supposed to inform the patient on the possibility of condylar dislocations, condylar sag, and clockwise/anticlockwise rotations of occlusal surface after surgery. We also changed point 5, "tooth and periodontal disease," in "tooth damage, avulsion, and periodontal disease" because we believe patients should be informed better on the risk of injuries to the dental elements such as fractures, luxations, or avulsions, especially to incisors. In the opinion of the authors, this new informed consent form allows the patient to know the risks related to the orthodontic/surgical therapy better, thus preserving the surgeons from the civil risk and penalties of omission.