Article type
Year
Abstract
Background:
Lack of patient-centered outcomes limits the usefulness of clinical trial evidence to inform healthcare decisions.
Objectives:
1) To investigate outcomes about which patients with coronary heart disease (CHD) are most concerned.
2) To make recommendations for selecting outcome measures in clinical trials and clinical practice.
Methods:
We reviewed outcome measures used in systematic reviews and clinical trials. Referring to our review results, the OMERACT framework and widely used quality of life scales, we designed a questionnaire about outcomes that concern people with CHD. The questionnaire was designed to have five main domains: death (DE), adverse events (AE), life impact (LI), resource use (RU), and pathophysiological manifestation (PM), with a total of 52 questions. The LI domain also contained four sub-domains including activity and participation (LIA), medical activity (LIM), physiology (LIP), and psychology (LIY). The PM domain contained four sub-domains including function (PMF), irreversible manifestation (PMI), reversible manifestation (PMR), and surrogate outcome (PMS). The reliability and validity of this questionnaire was proved to be good through presurvey. We conducted a survey of inpatients and outpatients with CHD in the Affiliated Hospital of Liaoning University of Traditional Chinese Medicine. We ranked outcomes according to total score of degrees of patient concern. We performed logistic regression to analyze the factors that influence patient concern.
Results:
According to degree of patient concern, the outcome domains ordered as follows: PMI, LIP, AE, PMF, PMR, PMS, DE, LIM, RU, LIA, LIY. The top five outcomes that concerned patients were: degree of infarction or heart injury (rank 1), major adverse cardiovascular events (rank 2 and rank 3), body aches (rank 4), digestive function and endocrine function (rank 5), and heart function (rank 5). There was no significant correlation between degrees of patient concern for outcomes and factors such as age and diagnosis.
Conclusions:
People with CHD care more about outcome domains such as PMI, LIP, AE, and PMF. Outcome measures in these domains should be considered more in further clinical trials and clinical practice.
Patient or healthcare consumer involvement:
Patients with CHD participated in this survey.
Lack of patient-centered outcomes limits the usefulness of clinical trial evidence to inform healthcare decisions.
Objectives:
1) To investigate outcomes about which patients with coronary heart disease (CHD) are most concerned.
2) To make recommendations for selecting outcome measures in clinical trials and clinical practice.
Methods:
We reviewed outcome measures used in systematic reviews and clinical trials. Referring to our review results, the OMERACT framework and widely used quality of life scales, we designed a questionnaire about outcomes that concern people with CHD. The questionnaire was designed to have five main domains: death (DE), adverse events (AE), life impact (LI), resource use (RU), and pathophysiological manifestation (PM), with a total of 52 questions. The LI domain also contained four sub-domains including activity and participation (LIA), medical activity (LIM), physiology (LIP), and psychology (LIY). The PM domain contained four sub-domains including function (PMF), irreversible manifestation (PMI), reversible manifestation (PMR), and surrogate outcome (PMS). The reliability and validity of this questionnaire was proved to be good through presurvey. We conducted a survey of inpatients and outpatients with CHD in the Affiliated Hospital of Liaoning University of Traditional Chinese Medicine. We ranked outcomes according to total score of degrees of patient concern. We performed logistic regression to analyze the factors that influence patient concern.
Results:
According to degree of patient concern, the outcome domains ordered as follows: PMI, LIP, AE, PMF, PMR, PMS, DE, LIM, RU, LIA, LIY. The top five outcomes that concerned patients were: degree of infarction or heart injury (rank 1), major adverse cardiovascular events (rank 2 and rank 3), body aches (rank 4), digestive function and endocrine function (rank 5), and heart function (rank 5). There was no significant correlation between degrees of patient concern for outcomes and factors such as age and diagnosis.
Conclusions:
People with CHD care more about outcome domains such as PMI, LIP, AE, and PMF. Outcome measures in these domains should be considered more in further clinical trials and clinical practice.
Patient or healthcare consumer involvement:
Patients with CHD participated in this survey.