Development of a Patient Reported Measure of Experimental Transplants with HIV and Ethics in the United States (PROMETHEUS)

Seaman, Shanti; Brown, Diane; Eno, Ann; Yu, Sile; Massie, Allan B.; Tobian, Aaron A. R.; Durand, Christine M.; Segev, Dorry L.; Wu, Albert W.; Sugarman, Jeremy

doi:10.1186/s41687-021-00297-y

Journal of Patient-Reported Outcomes

Table 1 PROMETHEUS literature review summary

From: Development of a Patient Reported Measure of Experimental Transplants with HIV and Ethics in the United States (PROMETHEUS)

Concept	Tool(s) Used	Quantitative or Qualitative	Clinical Context	Key Points	Reference
Consent Process	Spielberger STAI^a, Questionnaire	Quantitative	Cardiac Electrophysiology	Patients prefer to be made aware of possible risks. No significant difference between oral, written, and video consent formats.	Goldberger et al. 2011 [35]
	EDICT^a	Quantitative	Liver Transplantation	Development of “Evaluation of Donor Informed Consent Tool” to assess consent comprehension.	Gordon et al. 2015 [29]
	Narrative interviews	Qualitative	Bone-marrow Transplantation	Patients’ views toward consent process change after reporting disappointment with procedure.	Little et al. 2008 [17]
	Telephone questionnaire	Qualitative	Open Inguinal Hernia Repairs	Patients have better recall of benefits than of complications, intraoperative details, or post-operative instructions.	Uzzaman et al. 2012 [36]
	QuIC^a	Quantitative	Oncology	Therapeutic misconceptions held by participants and investigators need to be directly addressed to improve the quality of informed consent.	Joffe et al. 2001 [38]
	Deliberative Engagement Sessions	Qualitative	General Medical Research	Patients want to be told about research and have a choice but are open to streamlining those disclosures.	Kass et al. 2016 [39]
	BICEP^a	Qualitative	General Medical Research	Independent telephone evaluations of the quality of informed consent are feasible. More focus needed on voluntariness of continued participation and that participation has purpose aside from personal benefit.	Sugarman et al. 2005 [40]
Decision Making	EORTC QLQ-C30^a, DRS^a	Quantitative	Oncology	3 types of medical decision-making roles: passive, collaborative, and active. Time since treatment may have greatest effect on decisional regret.	Davison et al. 2003 [28]
	CARE^a, SDM-Q-9^a, CPS/PPS^a, DRS^a	Quantitative	Oncology	A patient’s desired role in the decision-making process must be assessed.	Nicolai et al. 2016 [33]
	Systematic review	Quantitative	Health Decisions	Less decisional conflict, greater satisfaction with information provided and more involvement in the decision-making process were associated with less regret.	Becerra Perez et al. 2016 [32]
	Qualitative data review	Qualitative	High-Risk Surgery in Older Adults	Discussion of treatment options, clarification of goals, and preparation for expected and unexpected outcomes are important for informed decision-making.	Steffens et al. 2016 [31]
	DRS^a	Quantitative	Major Thoracic and Abdominal Surgery	Clinicians need to emphasize that the patient has a real choice. Correlation between depression and decisional regret.	Wilson et al. 2017 [34]
Trust	Systematic review, thematic synthesis	Qualitative	Renal Transplantation	Tenuous eligibility causes patients to feel unfairly dismissed and suspicious of discrimination.	Tong et al. 2015 [20]
Trust	Questionnaire	Quantitative	General Medical Research	Components of trust (fidelity, honesty, safety, etc.) did not emerge as distinct factors. Patients did not differentiate trust in physician researchers from trust in medical researchers generally.	Hall et al. 2006 [37]
Emotions	EQ-5D QoL Instrument^a	Quantitative	Renal Transplantation	Clinicians have more accurate perceptions of post-transplant quality of life than patients do. Patients may not fully understand what post-transplant treatment will look like.	Cleemput et al. 2003 [15]
	Cantril’s ladder^a, VAS^a	Quantitative	Renal Transplantation	Patients overestimate post-transplant quality of life. Low optimism found to be a risk factor for early distress.	Schulz et al. 2014 [18]
	Semi-structured interviews	Qualitative	Islet Cell Transplantation	Patients need to be prepared for the risks involved in transplant and need to develop coping strategies for disappointment at any stage.	Speight et al. 2016 [19]
	Systematic review, thematic synthesis	Qualitative	Renal Transplantation	Balancing concerns for their living donor along with their own health creates tension for patients. Major themes in patient attitudes towards living donor transplantion.	Hanson et al. 2015 [30]
Impact of Transplant	Self-report surveys, Diary, Medication Monitoring	Qualitative	Renal Transplantation	Patients had unrealistic expectations of return to normalcy and were not prepared for the challenges of living after transplantation.	Crawford et al. 2017 [16]

^aExplanation of Tools:
Spielberger STAI: Spielberger State-Trait Anxiety Inventory – 20 questions that assess anxiety at one particular moment in time (state) and another 20 questions that assess general anxiety level (trait)
EDICT: Evaluation of Donor Informed Consent Tool – 49 true/false/unsure questions designed to assess living donors' comprehension of the living donation process.
QuIC: Quality of Informed Consent – 34 item questionnaire to assess the informed consent process for clinical research of cancer therapies. Responses to individual questions are combined to create a knowledge score ranging from 0 (least) to 100.
BICEP: Brief Informed Consent Evaluation Protocol – short telephone interview to evaluate the informed consent process used to create an Informed Consent Aggregate Score (ICAS) and Therapeutic Misconception Aggregate Score (TMAS). Each item is scored 1 for Yes and 0 for No and the aggregate score is the sum.
EORTC QLQ-C30: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (version 3) – a 30-item questionnaire grouped into five functional domains (physical, role, cognitive, emotional, social), three symptom domains (fatigue, pain, nausea and vomiting), five single-symptom items (dyspnea, insomnia, anorexia, diarrhea, constipation), a financial concerns item, an overall health domain, and an overall quality of life domain.
DRS: Five-item self-reported Likert Scale (4, strongly disagree; 3, disagree; 2, neither agree nor disagree; 1, agree; and 0, strongly agree) including: 1, it was the right decision; 2, I regret the decision that was made; 3, I would make the same decision if I had to do it again; 4, the decision did me a lot of harm; and 5, the decision was a wise one.
CARE: Consultation and Relational Empathy measure – 10 items that are rated on a five-point Likert scale to assess patients’ views of physicians’ empathic communication skills.
SDM-Q-9: Nine-item Shared Decision-Making Questionnaire that asks patients to rate items on a six-point Likert scale. Items cover: 1, disclosure that a decision must be made; 2, formulation of the partners’ equality; 3, presentation of treatment options; 5, investigation of the patient’s understanding and expectations; 6, identification of both parties’ preferences; 7, negotiation; 8, arriving at a shared decision; and 9, arranging follow-up.
CPS: Control Preferences Scale – asks the patient which of five options best describes their preferred role in decision-making.
PPS: Patient Perception Scale – asks the patient which of five options best describes how the decision was made.
EQ-5D QoL Instrument: Measures health-related quality of life using descriptive and valuation parts. The descriptive part is made up of five items that represent different dimensions of health (mobility, self-care, usual activities, pain and discomfort, and anxiety and depression) along with three levels of severity (no problems, some problems, and severe problems). The valuation part consists of a Visual Analogue Scale (VAS) where respondents rank their quality of life for each health state described in the descriptive part from 0 (worst imaginable health state) to 100 (best imaginable health state).
Cantril’s ladder: Single-item measure of quality of life that is easy to understand and easy to administer.
VAS: A 10-point visual analogue scale ranging from 1 (worst imaginable quality of life) to 10 (best imaginable quality of life)

Back to article page