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Informed Consent

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1. Induction of labour: information and consent still inadequate

Induction of labour: information and consent still inadequate Prescrire IN ENGLISH - Spotlight ''Induction of labour: information and consent still inadequate'', 1 December 2017 {1} {1} {1} | | > > > Induction of labour: information and consent still inadequate Spotlight Every month, the subjects in Prescrire’s Spotlight. 100 most recent :  |   |   |   |   |   |   |   |   |  Spotlight Induction of labour: information (...) and consent still inadequate In France, a survey revealed that women are given insufficient information prior to induction of labour, and their consent is often not sought. In France in 1980, labour was induced in 10% of deliveries. Between 1995 and 2003 this percentage rose to 20%, to reach almost 23% in 2010. The French group Ciane (Collectif interassociatif autour de la naissance, a coalition of associations dedicated to childbirth issues) emphasises the importance of improving women's experience

2017 Prescrire

2. Informed consent for clinical treatment in low-income setting: evaluating the relationship between satisfying consent and extent of recall of consent information (PubMed)

Informed consent for clinical treatment in low-income setting: evaluating the relationship between satisfying consent and extent of recall of consent information Treatment informed consent aims to preserve the autonomy of patients in the clinician - patient relationship so as to ensure valid consent. An acceptable method of evaluating understanding of consent information is by assessing the extent of recall by patients of the pieces information believed to have been passed across. When concerns (...) are not satisfactorily addressed from the patients' perspective, recall of consent information may be low.This study is a questionnaire - based cross - sectional interview of consecutive adult surgical patients who could give their respective medical histories and who were booked for elective major surgical procedures over a period of 7 months in a tertiary health institution in southeastern Nigeria. Four to five days after a formal consent session, during ward admission, extent of recall of information

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2017 BMC medical ethics

3. Building an Informed Consent Tool Starting with the Patient: The Patient-Centered Virtual Multimedia Interactive Informed Consent (VIC) (PubMed)

Building an Informed Consent Tool Starting with the Patient: The Patient-Centered Virtual Multimedia Interactive Informed Consent (VIC) Patient safety and quality of care are at risk if the informed consent process does not emphasize patient comprehension. In this paper, we describe how we designed, developed, and evaluated an mHealth tool for advancing the informed consent process. Our tool enables the informed consent process to be performed on tablets (e.g., iPads) utilizing virtual coaching (...) we conducted to evaluate the effectiveness, efficiency, and user satisfaction with our mHealth App to enhance the informed consent process. Using the UCD approach we were able to design, develop, and evaluate a highly interactive mHealth App to deliver the informed consent process.

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2018 AMIA Annual Symposium Proceedings

5. Informed consent for endoscopic procedures in Portugal - do we need a thoroughly detailed consent form? (PubMed)

Informed consent for endoscopic procedures in Portugal - do we need a thoroughly detailed consent form? © Georg Thieme Verlag KG Stuttgart · New York.

2019 Endoscopy

6. Informed consent in randomised controlled trials: development and preliminary evaluation of a measure of Participatory and Informed Consent (PIC) (PubMed)

Informed consent in randomised controlled trials: development and preliminary evaluation of a measure of Participatory and Informed Consent (PIC) Informed consent (IC) is an ethical and legal prerequisite for trial participation, yet current approaches evaluating participant understanding for IC during recruitment lack consistency. No validated measure has been identified that evaluates participant understanding for IC based on their contributions during consent interactions. This paper (...) outlines the development and formative evaluation of the Participatory and Informed Consent (PIC) measure for application to recorded recruitment appointments. The PIC allows the evaluation of recruiter information provision and evidence of participant understanding.Published guidelines for IC were reviewed to identify potential items for inclusion. Seventeen purposively sampled trial recruitment appointments from three diverse trials were reviewed to identify the presence of items relevant to IC

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2017 Trials

7. Informing Adults With Back Pain About Placebo Effects: Randomized Controlled Evaluation of a New Website With Potential to Improve Informed Consent in Clinical Research. (PubMed)

Informing Adults With Back Pain About Placebo Effects: Randomized Controlled Evaluation of a New Website With Potential to Improve Informed Consent in Clinical Research. Placebo effects and their underpinning mechanisms are increasingly well understood. However, this is poorly communicated to participants in placebo-controlled trials. For valid informed consent, participants should be informed about the potential benefits and risks of participating in placebo-controlled trials. Existing (...) in clinical trial settings, it could support informed consent in placebo-controlled trials.©Felicity L Bishop, Maddy Greville-Harris, Jennifer Bostock, Amy Din, Cynthia A Graham, George Lewith, Christina Liossi, Tim O'Riordan, Peter White, Lucy Yardley. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 17.01.2019.

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2019 Journal of medical Internet research

8. What information and the extent of information research participants need in informed consent forms: a multi-country survey (PubMed)

What information and the extent of information research participants need in informed consent forms: a multi-country survey The use of lengthy, detailed, and complex informed consent forms (ICFs) is of paramount concern in biomedical research as it may not truly promote the rights and interests of research participants. The extent of information in ICFs has been the subject of debates for decades; however, no clear guidance is given. Thus, the objective of this study was to determine (...) the perspectives of research participants about the type and extent of information they need when they are invited to participate in biomedical research.This multi-center, cross-sectional, descriptive survey was conducted at 54 study sites in seven Asia-Pacific countries. A modified Likert-scale questionnaire was used to determine the importance of each element in the ICF among research participants of a biomedical study, with an anchored rating scale from 1 (not important) to 5 (very important).Of the 2484

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2018 BMC medical ethics

9. Effect of a Multimedia Patient Decision Aid to Supplement the Informed Consent Process of a Peripherally Inserted Central Venous Catheter Procedure: Pre-Post Quasi-Experimental Study. (PubMed)

Effect of a Multimedia Patient Decision Aid to Supplement the Informed Consent Process of a Peripherally Inserted Central Venous Catheter Procedure: Pre-Post Quasi-Experimental Study. Informed consent is a complex process to help patients engage in care processes and reach the best treatment decisions. There are many limitations to the conventional consent process that is based on oral discussion of information related to treatment procedures by the health care provider. A conclusive body (...) of research supports the effectiveness of multimedia patient decision aids (PtDAs) in the consent process in terms of patient satisfaction, increased knowledge about the procedure, reduced anxiety level, and higher engagement in the decision making. Little information is available about the effectiveness of multimedia PtDAs in the consent process of invasive therapeutic procedures such as the peripherally inserted central venous catheter (PICC).The objective of this study was to examine the effectiveness

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2018 JMIR medical informatics

10. Challenges in informed consent decision-making in Korean clinical research: A participant perspective. (PubMed)

Challenges in informed consent decision-making in Korean clinical research: A participant perspective. This study investigated how the essential elements of informed consent are realised during the consent process and examined the challenges in obtaining genuine informed consent in Korea.Through purposive sampling, we recruited 21 subjects from those participating in anticancer drug research since 2013. We undertook 1:1 in-depth interviews and analysed the data by framework analysis.Themes (...) difficulties through communication with trial researchers. Doubts were raised about whether participants had sufficient capacity and free will to provide informed consent.There is a concern that informed consent can fall short of genuine in Korea. To ensure informed consent meets the international standard, greater efforts should be made to establish an explicit standard operational protocol for obtaining informed consent.

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2019 PLoS ONE

11. Just-in-time consent: The ethical case for an alternative to traditional informed consent in randomized trials comparing an experimental intervention with usual care. (PubMed)

Just-in-time consent: The ethical case for an alternative to traditional informed consent in randomized trials comparing an experimental intervention with usual care. Informed consent for randomized trials often causes significant and persistent anxiety, distress and confusion to patients. Where an experimental treatment is compared to a standard care control, much of this burden is potentially avoidable in the control group. We propose a "just-in-time" consent in which consent discussions take (...) place in two stages: an initial consent to research from all participants and a later specific consent to randomized treatment only from those assigned to the experimental intervention. All patients are first approached and informed about research procedures, such as questionnaires or tests. They are also informed that they might be randomly selected to receive an experimental treatment and that, if selected, they can learn more about the treatment and decide whether or not to accept it at that time

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2018 Clinical trials (London, England)

12. Improved participants' understanding of research information in real settings using the SIDCER informed consent form: a randomized-controlled informed consent study nested with eight clinical trials. (PubMed)

Improved participants' understanding of research information in real settings using the SIDCER informed consent form: a randomized-controlled informed consent study nested with eight clinical trials. This study aimed to test the applicability and effectiveness of the principles and informed consent form (ICF) template proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) across multiple clinical trials involving Thai research participants with various (...) conditions.A single-center, randomized-controlled study nested with eight clinical trials was conducted at Thammasat University Hospital, Thailand. A total of 258 participants from any of the eight clinical trials were enrolled and randomly assigned to read either the SIDCER ICF (n = 130) or the conventional ICF (n = 128) of the respective trial. Their understanding of necessary information was assessed using the post-test questionnaire; they were allowed to consult a given ICF while completing

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2016 European journal of clinical pharmacology

13. Communicating Risks and Benefits in Informed Consent for Research: A Qualitative Study (PubMed)

Communicating Risks and Benefits in Informed Consent for Research: A Qualitative Study Multiple studies have documented major limitations in the informed consent process for the recruitment of clinical research participants. One challenging aspect of this process is successful communication of risks and benefits to potential research participants. This study explored the opinions and attitudes of informed consent experts about conveying risks and benefits to inform the development of a survey (...) about the perspectives of research nurses who are responsible for obtaining informed consent for clinical trials. The major themes identified were strategies for risks and benefits communication, ensuring comprehension, and preparation for the role of the consent administrator. From the experts' perspective, inadequate education and training of the research staff responsible for informed consent process contribute to deficiencies in the informed consent process and risks and benefits communication

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2017 Global qualitative nursing research

14. Informed consent for invasive procedures in the emergency department: a qualitative systematic review

Informed consent for invasive procedures in the emergency department: a qualitative systematic review Print | PDF PROSPERO This information has been provided by the named contact for this review. CRD has accepted this information in good faith and registered the review in PROSPERO. The registrant confirms that the information supplied for this submission is accurate and complete. CRD bears no responsibility or liability for the content of this registration record, any associated files

2019 PROSPERO

15. Communication of informed consent between clinicians and patients

Communication of informed consent between clinicians and patients Print | PDF PROSPERO This information has been provided by the named contact for this review. CRD has accepted this information in good faith and registered the review in PROSPERO. The registrant confirms that the information supplied for this submission is accurate and complete. CRD bears no responsibility or liability for the content of this registration record, any associated files or external websites. Email salutation (e.g

2019 PROSPERO

16. Comparing two methods for delivering clinical trial informed consent information to older adults: singular versus stepped approach. (PubMed)

Comparing two methods for delivering clinical trial informed consent information to older adults: singular versus stepped approach. Adapting the informed consent process to the needs of older adults may enhance engagement and willingness to participate in a clinical trial. A key aspect of the process is being provided with written clinical trial information and consent documents and having an opportunity to discuss the information with the researcher. However, there are no guidelines (...) on the most appropriate method for delivering this information to older adults and it is not known whether the delivery method is a facilitator or barrier towards clinical trial participation.To compare two delivery methods of informed consent on recruitment, refusal to continue and randomisation rates in a general practice-based clinical trial involving older adults.In a matched cohort sub-study as part of the STAtins in Reducing Events in the Elderly clinical trial, 520 participants were allocated

2018 Clinical trials (London, England)

17. Informed Consent Formats by Information Preference and Priority

Informed Consent Formats by Information Preference and Priority Informed Consent Formats by Information Preference and Priority - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Informed Consent Formats (...) Mellon University Study Details Study Description Go to Brief Summary: This study will test whether different formats of medical informed consent documents can help improve understanding and confidence in decision-making for clinical trials. The study will be primarily run through an online survey. Condition or disease Intervention/treatment Phase Consent Forms Asthma Behavioral: Original consent form Behavioral: Shortened consent form Behavioral: Reordered, shortened consent form Behavioral

2018 Clinical Trials

18. Informed consent for strabismus surgery: the importance of patient information sheets. (PubMed)

Informed consent for strabismus surgery: the importance of patient information sheets. To analyze the additive effect of supplementing verbal consent with written patient information sheets in optimizing patients' and families' understanding of strabismus surgery.A prospective randomized study was conducted with 28 patients for strabismus surgery randomized into two groups: group 1 with standardized oral informed consent, and group 2 with standardized oral consent and a written information (...) sheet. A confidential questionnaire with 13 questions was completed by patients and families before surgery.A total of 7 adults and 21 children were included in the study. The mean score (number of correct answers) for group 1 was 4.14 ± 1.99; for group 2, 5.79 ± 2.12 (P = 0.044), indicating that patients and families in group 2 understood their strabismus surgery better than those in group 1. Areas needing more emphasis during the consent process were identified, including risk of under

2018 JAAPOS - Journal of the American Association for Pediatric Ophthalmology and Strabismus

19. Information needs of patients in spine surgery: development of a question prompt list to guide informed consent consultations. (PubMed)

Information needs of patients in spine surgery: development of a question prompt list to guide informed consent consultations. Informed consent is mandatory before surgery and fundamental in the physician-patient interaction. However, communication is sometimes suboptimal.The objective was to develop a question prompt list (QPL) for patients undergoing spine surgery (spinal neurosurgery-QPL, "SN-QPL") to encourage them to acquire information during the informed consent consultation (ICC (...) ) and assess patients' information needs.We conducted a prospective uncontrolled single center study in order to develop a QPL for patients undergoing spine surgery.Patients inclusion criteria were as follows: (1) planned spinal surgery, (2) age 18 to 80 years, (3) legal capacity, (4) ability to understand and respond to questionnaires, and (5) informed consent.We applied the following self-report measures: the developed preliminary QPL with regard to surgery topics and assessment of patients' information

2018 The Spine Journal

20. Insight in Information Provision Prior to Obtaining Surgical Informed Consent-by Audiotaping Outpatient Consultations. (PubMed)

Insight in Information Provision Prior to Obtaining Surgical Informed Consent-by Audiotaping Outpatient Consultations. Literature suggests that patient-informing process prior to obtaining surgical informed consent (SIC) does not function well. This study aimed to provide insight into the current practice of SIC in the Netherlands.This is a prospective, observational, and multicenter study, conducted in one academic and two non-academic teaching hospitals in the Netherlands. Audio recordings (...) were made during outpatient consultations with patients presenting with Dupuytren Disease. The recorded informing process was scored according to a checklist. Written documentation of the SIC process in the patient's chart was compared to these scored checklists. Time spent on SIC during the consultations was also recorded.A total of 41 outpatient consultations were included in the study. Consultations were conducted by 25 plastic surgeons and their residents. Average time spent on SIC was 55.6

2018 World Journal of Surgery

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