Nursing - Research Publications
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ItemInterventions to improve patient understanding of cancer clinical trial participation: a systematic review(WILEY, 2017-03)Patient misunderstanding of cancer clinical trial participation is identified as a critical issue and researchers have developed and tested a variety of interventions to improve patient understanding. This systematic review identified nine papers published between 2000 and 2013, to evaluate the effects of interventions to improve patient understanding of cancer clinical trial participation. Types of interventions included audio-visual information, revised written information and a communication training workshop. Interventions were conducted alone or in combination with other forms of information provision. The nine papers, all with methodological limitations, reported mixed effects on a small range of outcomes regarding improved patient understanding of cancer clinical trial participation. The methodological limitations included: (1) the intervention development process was poorly described; (2) only a small element of the communication process was addressed; (3) studies lacked evidence regarding what information is essential and critical to enable informed consent; (4) studies lacked reliable and valid outcome measures to show that patients are sufficiently informed to provide consent; and (5) the intervention development process lacked a theoretical framework. Future research needs to consider these factors when developing interventions to improve communication and patient understanding during the informed consent process.
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ItemIdentifying essential information to support patient decision-making regarding participation in cancer clinical trials: A Delphi study(WILEY, 2018-11)PURPOSES: This research set out to contribute to ongoing efforts to improve the quality of informed consent information provided to patients by specifically focusing on establishing consensus with regard to essential information to enhance the informed consent process. DESIGN AND METHODS: A Delphi consensus method was used to conduct three rounds of online surveys. Five groups of experts directly or indirectly involved in the informed consent process were invited to participate: patients, family members/friends, physicians, other health professionals and other key informants, including ethicists, contract research staff and pharmaceutical company staff. FINDINGS: Of 156 eligible participants, 101 participants (64.7%) completed all three rounds. In round 1, 994 information items were reported and generated into 74 statements. These were grouped under eight headings essential to the informed consent process. In rounds 2 and 3, the list was reduced to 15 statements representing consensus on essential information to be included in a summarised patient information document to support decision-making regarding trial participation. Risks and discomforts, participation requirements and trial governance were identified as important considerations. CONCLUSIONS: The 15 essential statements identified in this study could be used as components of a summarised information sheet given to potential cancer clinical trial participants, as an adjunct to the informed consent process. A robust evaluation of the impact of these statements on the quality of the informed consent process is needed.
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ItemDevelopment and testing of a guideline document to provide essential information for patient decision making regarding cancer clinical trials(WILEY, 2020-09)OBJECTIVE: To develop and test a guideline document to advise the content of a summarised patient information form (SPIF) regarding cancer clinical trials. METHODS: A two-phase study was undertaken to inform the development of the guideline document. In phase 1, 15 statements drawn from an international Delphi study and participant commentary were used to draft content for the guideline document. In phase 2, Delphi participants were invited to contribute to a five-step process via an online survey, to feedback on the guideline document, including the process for guideline formulation, testing application, revision, utility and clarity assessment, and completion. RESULTS: Over 73% of respondents to the online survey agreed that a sample SPIF generated by the draft guideline could support patient decision making. After the draft guideline revision, the researcher and four health professionals used the guideline to independently create a SPIF. The Flesch-Kincaid reading ease scores of the sample SPIFs were between 61.3 and 66.5, with reading levels between 7.8 and 8.8, indicating that the guideline document can assist health professionals with the generation of an understandable SPIF. The reference group members provided positive feedback on the guideline document, and an expert on plain language in healthcare information proofread the guideline document. CONCLUSION: The approach used in the study ensured the potential of the guideline document developed to enable generation of SPIFs that provide patients considering participation in a cancer clinical trial with essential and understandable information to support their decision making.