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Informed Consent

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1. Oxford Video Informed Consent Tool (OxVIC): a pilot study of informed video consent in spinal surgery and preoperative patient satisfaction. (PubMed)

Oxford Video Informed Consent Tool (OxVIC): a pilot study of informed video consent in spinal surgery and preoperative patient satisfaction. The British Association of Spinal Surgeons recently called for updates in consenting practice. This study investigates the utility and acceptability of a personalised video consent tool to enhance patient satisfaction in the preoperative consent giving process.A single-centre, prospective pilot study using questionnaires to assess acceptability of video (...) consent tool was found to be a positive adjunct to traditional consenting methods. Patient-clinician consent dialogue can now be documented. A randomised controlled study to further evaluate the effects of video consent on patients' retention of information, preoperative and postoperative anxiety, patient reported outcome measures as well as length of stay may be beneficial.© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions

2019 BMJ open

2. 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

3. 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

4. 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

6. 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

7. 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

8. 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 Controlled trial quality: predicted high

9. 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

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. 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 Controlled trial quality: uncertain

12. Impact of informed consent content and length on recruitment of older adults into a community based primary prevention trial (PubMed)

Impact of informed consent content and length on recruitment of older adults into a community based primary prevention trial To compare recruitment, refusal and randomisation rates of older adults into a general practice-based clinical trial with two versions (varied format, content and language) of the Participant Information and Consent Form (PICF).This prospective PICF study was conducted within the STAREE (STAtins in Reducing Events in the Elderly) clinical trial. Participants phone (...) screened between October 2015 to February 2016 formed Group 1 and were mailed the extended PICF version and participants phone screened between October 2016 to February 2017 formed Group 2 and were mailed the shortened PICF version. Participants who attended a subsequent baseline screening visit were guided through a comprehensive informed consent process.During the screening phase of the trial, the likelihood of refusing trial participation was lower in Group 2 compared to Group 1 equating

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2018 Contemporary clinical trials communications Controlled trial quality: uncertain

13. 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)

14. 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 Controlled trial quality: uncertain

15. 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

16. 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

17. A systematic review of public perception and attitudes toward informed consent in biobanking.

A systematic review of public perception and attitudes toward informed consent in biobanking. 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

2019 PROSPERO

18. Informed Consent and the Oncologist: Legal Duties to Discuss Costs of Treatment

Informed Consent and the Oncologist: Legal Duties to Discuss Costs of Treatment I not a bot. Resume. Are you not a robot? Click on the button to continue: I not a bot. Resume.

2017 MedicalVideos

19. 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

20. 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

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