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Development and evaluation of a measure of patient-reported symptoms of Blepharitis.

ABSTRACT: Blepharitis is an ocular surface disease and chronic ophthalmic condition. This paper reports on the development of psychometric evaluation of a patient-reported measure of blepharitis symptoms.Self-reports of 13 blepharitis symptoms collected in a Phase 3 multi-site, randomized, double-masked, 4-arm parallel group, clinical trial of 907 individuals with blepharitis (mean age?=?62, range: 19-93; 57% female) were analyzed. Symptoms asked about were: eyes that itch; eyes that burn; eyelids feel heavy or puffy; feel like something is in your eye; dry eyes; gritty eyes; irritated eyes; eyes that tear or water; crusty eyes; flaking from your eyelids; eyelids that are stuck together; red eyes or eyelids; and debris like pieces of skin or dandruff in your eyes.Categorical factor analyses provided support for two multi-item symptom scales: Irritation (9 items, alpha?=?0.88) and Debris (4 items, alpha?=?0.85). Spearman-rank order correlations of the Irritation and Debris scales with the Ocular Surface Disease total score were 0.63 and 0.41, respectively (p's??0.05), and irritation (r?=?0.47, p?

SUBMITTER: Hosseini K

PROVIDER: S-EPMC5765649 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature

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Development and evaluation of a measure of patient-reported symptoms of Blepharitis.

Hosseini Kamran K Bourque Linda B LB Hays Ron D RD

Health and quality of life outcomes 20180111 1

<h4>Background</h4>Blepharitis is an ocular surface disease and chronic ophthalmic condition. This paper reports on the development of psychometric evaluation of a patient-reported measure of blepharitis symptoms.<h4>Methods</h4>Self-reports of 13 blepharitis symptoms collected in a Phase 3 multi-site, randomized, double-masked, 4-arm parallel group, clinical trial of 907 individuals with blepharitis (mean age = 62, range: 19-93; 57% female) were analyzed. Symptoms asked about were: eyes that it ...[more]

PMID: 29325546

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Project description:OBJECTIVES: Despite a documented clinical need, no patient reported outcome (PRO) symptom measure meeting current regulatory requirements for clinically relevant end points is available for the evaluation of treatment benefit in diarrhea-predominant IBS (IBS-D). METHODS: Patients (N=113) with IBS-D participated in five study phases: (1) eight concept elicitation focus groups (N=34), from which a 17-item IBS-D Daily Symptom Diary and four-item IBS-D Symptom Event Log (Diary and Event Log) were developed; (2) one-on-one cognitive interviews (N=11) to assess the instrument's comprehensiveness, understandability, appropriateness, and readability; (3) four data triangulation focus groups (N=32) to confirm the concepts elicited; (4) two hybrid (concept elicitation and cognitive interview) focus groups (N=16); and (5) two iterative sets of one-on-one cognitive interviews (N=20) to further clarify the symptoms of IBS-D and debrief a revised seven-item Diary and four-item Event Log. RESULTS: Of thirty-six concepts initially identified, 22 were excluded because they were not saturated, not clinically relevant, not critical symptoms of IBS-D, considered upper GI symptoms, or too broad or vaguely defined. The remaining concepts were diarrhea, immediate need (urgency), bloating/pressure, frequency of bowel movements, cramps, abdominal/stomach pain, gas, completely emptied bowels/incomplete evacuation, accidents, bubbling in intestines (bowel sounds), rectal burning, stool consistency, rectal spasm, and pain while wiping. The final instrument included a daily diary with separate items for abdominal and stomach pain and an event log with four items completed after each bowel movement as follows: (1) a record of the bowel movement/event and an assessment of (2) severity of immediacy of need/bowel urgency, (3) incomplete evacuation, and (4) stool consistency (evaluated using the newly developed Astellas Stool Form Scale). Based on rounds of interviews and clinical input, items considered secondary or nonspecific to IBS-D (rectal burning, bubbling in intestines, spasms, and pain while wiping) were excluded. CONCLUSIONS: The IBS-D Symptom Diary and Event Log represent a rigorously developed PRO instrument for the measurement of the IBS-D symptom experience from the perspective of the patient. Its content validity has been supported, and future work should evaluate the instrument's psychometric properties.

Project description:Background:The quality of life of patients at all stages of hematological malignancy is greatly affected by the disease and its treatment. There is a wide range of health-related quality of life (HRQoL) issues important to these patients. Any new instrument developed to measure HRQoL of such patients should be content valid, i.e., the items should be comprehensively relevant to the patients and their health condition. The aim of the present study was to examine content validity of a hematological malignancy specific patient reported outcome measure (HM-PRO) developed for use in routine clinical practice. Methods:Following literature review and semi-structured interviews, the generated themes and sub-themes were discussed to develop the prototype version of the HM-PRO. A 4-step approach was used for content validation: initial testing and cognitive interviewing; item rating; content validity panel meeting; final field testing and cognitive interviewing. Additional questions related to patients' perception of recall period and preferred sentence structure (i.e., question or statement) of the items were also asked during cognitive interviews. Results:The content analysis of 129 transcribed semi-structured interviews resulted in the prototype version of the instrument consisting of 58 items grouped into two parts: Part A (impact/HRQoL - 34 items) and Part B (signs and symptoms - 24 items). The initial testing showed intra-class correlation coefficient (ICC) of >0.8 for both Part A and Part B. Item rating for language clarity, completeness, relevance, and response scale by experts and patients showed content validity index for scales average >0.8 for both Part A and Part B, except 0.64 for relevance for Part A by the patient panel. The final testing of the revised version of the instrument showed the Cronbach's alpha value of 0.91 for Part A and 0.76 for Part B, suggesting high internal consistency, and ICC of 0.91 for Part A and 0.76 for Part B. The recall period of "today" for Part-A and "last 3 days" for Part-B were the patients' preferred "recall period." Furthermore, the patients expressed preference to the HM-PRO items as statements. Conclusion:The findings of this study confirm that the HM-PRO possesses a strong content validity, includes all the issues important to patients and is easy to read, understand and respond to spontaneously.

Project description:BackgroundPatient-reported outcome (PRO) measures developed and validated on patients with the currently defined phenotypes of chronic rhinosinusitis (CRS) are needed to support clinical trials in CRS.ObjectiveThis study developed and examined the initial reliability and validity of the CRS-PRO, a new PRO measure of CRS.MethodsInstrument development was performed through structured interviews and focus groups with clinical experts and 45 patients with CRS meeting current definitions of disease, 21 patients with CRS without nasal polyps (CRSsNP), and 24 patients with CRS with nasal polyps (CRSwNP) to identify items important to patients. Then another 50 patients (32 with CRSsNP and 18 with CRSwNP) with stable CRS symptoms were enrolled to evaluate the reliability of the instrument. Each patient completed the CRS-PRO, Sinonasal Outcome Test-22 (SNOT-22), and 4 Patient-Reported Outcome Measurement Information System short forms at the baseline visit and then at least 7 days later.ResultsAfter the development process, 21 items were identified from the conceptual domains of physical symptoms, sensory impairment, psychosocial effects, and life impact. Using the responses of the 50 patients with CRS, 21 draft items were further refined to 12 items by eliminating conceptually similar or highly correlated items or those with low mean symptom severity. The 12-item questionnaire was shown to have excellent internal consistency (Cronbach α, 0.86) and test-retest reliability with a high intraclass correlation coefficient (0.89) and Pearson's correlation (r = 0.82, P < .0001). The 12-item CRS-PRO correlated highly with the longer SNOT-22 (r = 0.83, P < .0001) demonstrating its concurrent validity. We also demonstrated validity and reliability in a separate analysis for patients with CRSsNP and CRSwNP.ConclusionThe CRS-PRO is a concise, valid, and reliable measure that was developed with extensive input from patients with CRS with current disease definitions.

Project description:OBJECTIVE:Measuring the quality of care as experienced by patients is increasingly recognised as a way of improving healthcare services. However, disease-specific measures that take the patient journey into account are needed. This paper presents the development of such a measure for patients with heart disease and details the psychometric evaluation. DESIGN:The questionnaire was developed based on a literature review, qualitative interviews and a pilot-test. The psychometric evaluation of the measure was assessed using exploratory factor analysis (EFA) and confirmatory factor analysis (CFA), Cronbach's alpha coefficient and differential item functioning analysis with data from a population-based survey. SETTING:Denmark in 2013-2014. STUDY PARTICIPANTS:Nineteen heart patients, four relatives and eight health professionals participated in qualitative interviews in the development phase, and 15 patients participated in the pilot-test. The questionnaire was subsequently sent to a random sample of 5000 heart patients who were diagnosed in 2013. RESULTS:The comprehensive development phase and pilot-testing contributed to high content validity of the questionnaire. Eligible questionnaire responses were received from 2496 patients. EFA indicated a nine-factor model: communication at the hospital, communication with the general practitioner, information on disease and treatment, information on psychosocial aspects, rehabilitation/support, organisation, medication, involvement of relatives and consideration of comorbidity. CFA confirmed the proposed factor structure (eg, goodness-of-fit index=0.88, adjusted goodness-of-fit index=0.86, root mean square error of approximation=0.05), and Cronbach's alpha coefficient revealed good internal consistency of the factors (range: 0.69-0.93). CONCLUSIONS:The results suggest that this disease-specific patient-reported experience measure is of good quality when measuring the quality of care among heart patients. The inclusion of patients in the development phase contributed to high content validity, and subsequent psychometric evaluation found high construct validity and internal consistency. This measure may be especially relevant when seeking information about which aspects of care require improvement and the impact on health outcomes.

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Development and evaluation of a measure of patient-reported symptoms of Blepharitis.

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Development and evaluation of a measure of patient-reported symptoms of Blepharitis.

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