Interpreter proxy versus healthcare interpreter for administration of patient surveys following arthroplasty: a pilot study

Abstract Purpose: Clinical quality registries and other systems that conduct routine post-discharge surveillance of patient outcomes following surgery may have difficulty surveying patients who have limited proficiency in the language of the healthcare provider. Interpreter proxies (family and carers) are often used due to limited access to certified healthcare interpreters (due to cost or availability). The aim of this study was to assess the reliability of engaging interpreter proxies compared with certified healthcare interpreters for the administration of patient-reported health-related surveys for people with limited English proficiency (LEP). Methods: People with LEP and due for a routine 6-month telephone follow-up post knee or hip arthroplasty were invited to participate. Participants were randomly allocated to having their first interview with an interpreter proxy or a certified healthcare interpreter followed by the second (crossover) interview within 2 weeks (range: 4 to 12 days) after the first interview using the alternative method. Agreement between the two methods was assessed using quadratic weighted Cohen's kappa, intraclass correlation and concordance correlation co-efficient where appropriate for EQ-5D health domains, total Oxford hip and knee scores, patient satisfaction, operation success, readmission, reoperation, and post-surgical complication responses. The mean of the differences between the same data items collected by each of the two methods was also calculated. Results: 85 participants (96%) completed the study. There was substantial to excellent inter-rater agreement (kappa=0.69-0.87 and ICCs above 0.74) for all but one measure. The mean differences between family proxy and healthcare interpreter scores for each participant were small, ranging from 0.01 (score range of 1-5) to 0.72 (score range of 0-100). Conclusion: These results suggest that using interpreter proxies is a reliable alternative to certified healthcare interpreters in conducting patient-reported health surveys, potentially making this process easier and cost effective for researchers and registries.

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Interpreter proxy versus healthcare interpreter for administration of patient surveys following arthroplasty: a pilot study

10.21203/rs.2.12241/v1 ◽

2019 ◽

Author(s):

Daniel Xue ◽

Timothy Churches ◽

Elizabeth Armstrong ◽

Rajat Mittal ◽

Justine M. Naylor ◽

...

Keyword(s):

Limited English Proficiency ◽

Surgical Complication ◽

Intraclass Correlation ◽

Cost Effective ◽

Post Discharge ◽

Patient Reported ◽

Reported Health ◽

The Mean ◽

First Interview ◽

Score Range

Abstract Purpose: Clinical quality registries and other systems that conduct routine post-discharge surveillance of patient outcomes following surgery may have difficulty surveying patients who have limited proficiency in the language of the healthcare provider. Interpreter proxies (family and carers) are often used due to limited access to certified healthcare interpreters (due to cost or availability). The aim of this study was to assess the reliability of engaging interpreter proxies compared with certified healthcare interpreters for the administration of patient-reported health-related surveys for people with limited English proficiency (LEP). Methods: People with LEP and due for a routine 6-month telephone follow-up post knee or hip arthroplasty were invited to participate. Participants were randomly allocated to having their first interview with an interpreter proxy or a certified healthcare interpreter followed by the second (crossover) interview within 2 weeks (range: 4 to 12 days) after the first interview using the alternative method. Agreement between the two methods was assessed using quadratic weighted Cohen's kappa, intraclass correlation and concordance correlation co-efficient where appropriate for EQ-5D health domains, total Oxford hip and knee scores, patient satisfaction, operation success, readmission, reoperation, and post-surgical complication responses. The mean of the differences between the same data items collected by each of the two methods was also calculated. Results: 85 participants (96%) completed the study. There was substantial to excellent inter-rater agreement (kappa=0.69-0.87 and ICCs above 0.74) for all but one measure. The mean differences between family proxy and healthcare interpreter scores for each participant were small, ranging from 0.01 (score range of 1-5) to 0.72 (score range of 0-100). Conclusion: Using interpreter proxies is a reliable alternative to certified healthcare interpreters in conducting patient-reported health surveys, potentially making this process easier and cost effective for researchers and registries.

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Interpreter proxy versus healthcare interpreter for administration of patient surveys following arthroplasty: a pilot study

BMC Medical Research Methodology ◽

10.1186/s12874-019-0854-1 ◽

2019 ◽

Vol 19 (1) ◽

Author(s):

Daniel Xue ◽

Timothy Churches ◽

Elizabeth Armstrong ◽

Rajat Mittal ◽

Justine Maree Naylor ◽

...

Keyword(s):

Limited English Proficiency ◽

Surgical Complication ◽

Intraclass Correlation ◽

Cost Effective ◽

Post Discharge ◽

Patient Reported ◽

Reported Health ◽

The Mean ◽

First Interview ◽

Score Range

Abstract Background Clinical quality registries and other systems that conduct routine post-discharge surveillance of patient outcomes following surgery may have difficulty surveying patients who have limited proficiency in the language of the healthcare provider. Interpreter proxies (family and carers) are often used due to limited access to certified healthcare interpreters (due to cost or availability). The aim of this study was to assess the reliability of engaging interpreter proxies compared with certified healthcare interpreters for the administration of patient-reported health-related surveys for people with limited English proficiency (LEP). Methods People with LEP and due for a routine 6-month telephone follow-up post knee or hip arthroplasty were invited to participate. Participants were randomly allocated to having their first interview with an interpreter proxy or a certified healthcare interpreter followed by the second (crossover) interview within 2 weeks (range: 4 to 12 days) after the first interview using the alternative method. Agreement between the two methods was assessed using quadratic weighted Cohen’s kappa, intraclass correlation and concordance correlation co-efficient where appropriate for EQ-5D health domains, total Oxford hip and knee scores, patient satisfaction, operation success, readmission, reoperation, and post-surgical complication responses. The mean of the differences between the same data items collected by each of the two methods was also calculated. Results Eighty five participants (96%) completed the study. There was substantial to excellent inter-rater agreement (kappa = 0.69–0.87 and ICCs above 0.74) for all but one measure. The mean differences between family proxy and healthcare interpreter scores for each participant were small, ranging from 0.01 (score range of 1–5) to 0.72 (score range of 0–100). Conclusion These results suggest that using interpreter proxies is a reliable alternative to certified healthcare interpreters in conducting patient-reported health surveys, potentially making this process easier and cost effective for researchers and registries.

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Interpreter proxy versus healthcare interpreter for administration of patient surveys following arthroplasty: a pilot study.

10.21203/rs.2.12241/v3 ◽

2019 ◽

Author(s):

Daniel Xue ◽

Timothy Churches ◽

Elizabeth Armstrong ◽

Rajat Mittal ◽

Justine M. Naylor ◽

...

Keyword(s):

Limited English Proficiency ◽

Surgical Complication ◽

Intraclass Correlation ◽

Cost Effective ◽

Post Discharge ◽

Patient Reported ◽

Reported Health ◽

The Mean ◽

First Interview ◽

Score Range

Abstract Background: Clinical quality registries and other systems that conduct routine post-discharge surveillance of patient outcomes following surgery may have difficulty surveying patients who have limited proficiency in the language of the healthcare provider. Interpreter proxies (family and carers) are often used due to limited access to certified healthcare interpreters (due to cost or availability). The aim of this study was to assess the reliability of engaging interpreter proxies compared with certified healthcare interpreters for the administration of patient-reported health-related surveys for people with limited English proficiency (LEP). Methods: People with LEP and due for a routine 6-month telephone follow-up post knee or hip arthroplasty were invited to participate. Participants were randomly allocated to having their first interview with an interpreter proxy or a certified healthcare interpreter followed by the second (crossover) interview within 2 weeks (range: 4 to 12 days) after the first interview using the alternative method. Agreement between the two methods was assessed using quadratic weighted Cohen's kappa, intraclass correlation and concordance correlation co-efficient where appropriate for EQ-5D health domains, total Oxford hip and knee scores, patient satisfaction, operation success, readmission, reoperation, and post-surgical complication responses. The mean of the differences between the same data items collected by each of the two methods was also calculated. Results: 85 participants (96%) completed the study. There was substantial to excellent inter-rater agreement (kappa=0.69-0.87 and ICCs above 0.74) for all but one measure. The mean differences between family proxy and healthcare interpreter scores for each participant were small, ranging from 0.01 (score range of 1-5) to 0.72 (score range of 0-100). Conclusion: These results suggest that using interpreter proxies is a reliable alternative to certified healthcare interpreters in conducting patient-reported health surveys, potentially making this process easier and cost effective for researchers and registries.

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2020 Roger A. Mann Award Winner: Application of Computerized Adaptive Testing to the Foot and Ankle Ability Measure

Foot & Ankle Orthopaedics ◽

10.1177/2473011420s00067 ◽

2020 ◽

Vol 5 (4) ◽

pp. 2473011420S0006

Author(s):

Joseph T. O’Neil ◽

Otho R. Plummer ◽

Steven M. Raikin

Keyword(s):

Computerized Adaptive Testing ◽

Wide Spectrum ◽

Intraclass Correlation ◽

Adaptive Testing ◽

Mean Difference ◽

Foot And Ankle ◽

Patient Reported ◽

The Mean ◽

Ability Measure ◽

The Impact

Category: Other Introduction/Purpose: Patient-reported outcome measures (PROMs) are an increasingly important tool for assessing the impact of treatments orthopaedic surgeons render to patients. They provide information directly reported by the patient pertaining to the perception of their own outcome, functional status, and quality of life. Despite their importance, they can present a burden for patients as well as for a busy outpatient clinic. The Foot and Ankle Ability Measure (FAAM) is a freely available validated anatomy-specific outcome measure consisting of 32 questions, and has been found to be reliable for patients with a wide spectrum of foot and ankle conditions. We examined the validity and utility of a computerized adaptive testing (CAT) method to reduce the number of questions on the Foot and Ankle Ability Measure. Methods: A previously developed FAAM CAT system was applied to the responses of patients undergoing foot and ankle evaluation and treatment at a busy tertiary referral orthopaedic practice over a 3-year period (2017-2019). A total of 15,902 responses for the Activities of Daily Living (ADL) subscale and a total of 14,344 responses for the Sports subscale were analyzed. The accuracy of the CAT to replicate the full-form score was assessed using the mean and standard deviation of scores for both groups (FAAM versus CAT), frequency distributions of the scores and score differences for both groups, Pearson and intraclass correlation coefficients, and Bland-Altman assessments of patterns in score differences. Results: The CAT system required 11 questions to be answered for the ADL subscale in 85.1% of cases (compared to 22 questions for the FAAM) and 12 in 14.9% of cases. The number of questions answered on the Sports subscale was 6 in 66.4% of cases (compared to 10 for the FAAM) and 5 in 33.6% of cases. The mean difference between the full FAAM ADL subscale (out of 100 points) and CAT was 0.6266 of a point and scores were within 7.5 points in greater than 95% of cases. The mean difference between the FAAM Sports subscale (out of 100 points) and CAT was 0.5967 of a point and scores were within the minimal clinically important difference of 9 in greater than 95% of cases. Conclusion: The FAAM CAT was able to reduce the number of responses a patient would need to answer by nearly 50%, while still providing a valid outcome score. This measure can therefore be directly correlated with previously obtained full FAAM scores in addition to providing a foot/ankle-specific measure, which previously reported CAT systems are not able to do.

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The Impact of an Acute Vaso-Occlusive Crisis on Patient Reported Outcomes: The Magic Study

Blood ◽

10.1182/blood.v124.21.441.441 ◽

2014 ◽

Vol 124 (21) ◽

pp. 441-441 ◽

Cited By ~ 2

Author(s):

Julie A. Panepinto ◽

Lauren M Beverung ◽

T Charles Casper ◽

Larry J. Cook ◽

David C Brousseau

Keyword(s):

Multivariate Analysis ◽

Steady State ◽

Disease Severity ◽

Post Discharge ◽

Hrql Score ◽

Hospital Site ◽

Patient Reported ◽

The Mean ◽

The Impact ◽

Over Time

Abstract Acute vaso-occlusive crises (VOC) are the most common complication in sickle cell disease (SCD) and frequently result in hospitalization. The impact of an acute VOC on patient reported outcomes (PROs) over time is not known. It is necessary to describe the patterns of change over time of these outcomes for future interventions that aim to optimize PROs. The objective of this study was to determine the impact over time of an acute VOC on the health-related quality of life (HRQL-a specific type of PRO) of children with SCD. A multi-center prospective trial was conducted within the setting of a randomized controlled trial (the Magnesium in Crisis or MAGiC trial) that recruited from eight United States Children’s hospitals. Eligibility criteria included children ages 5 to 21 years with hemoglobin SS disease or β0thalassemia who were admitted to the hospital for a VOC and required intravenous administration of opioids. The children were asked to complete the PedsQL SCD and Fatigue HRQL modules at four time points (T0= at time of admission to hospital, T1= 48 hours from admission, T2= approximately 7 days post discharge, T3= steady state – complete resolution of the acute event, one month or more from discharge). The primary outcomes were the SCD and Fatigue Total HRQL scores. Secondary analyses examined specific HRQL domain scores. HRQL scores range from 0-100 with higher scores representing better HRQL. HRQL scores of 60-80 represent intermediate functioning. Descriptive statistics including t-tests for paired differences in scores were performed and a multivariate analysis using a linear mixed effects model was used to determine significant differences. The following covariates were included in the model: hospital site, age, gender, hydroxyurea use, disease severity (ever had acute chest syndrome and/or hospitalized for 3 or more VOC in the prior 3 years), and steady state HRQL score. A total of 204 children participated in the trial. The mean age was 13.6 years and 51% were female. The mean SCD total HRQL scores over time were as follows: T0=48.5, T1=48.5, T2=59.5, and T3=60. The mean Fatigue HRQL total scores over time were as follows: T0=53.9, T1=50.8, T2=61.3, and T3=62.0. In the multivariate analysis, there was no significant change from T0 to T1 for the Total SCD HRQL score. There was a significant increase of 11.8 points (p<0.01) in the Total SCD HRQL score at T2. The same pattern was seen for the Total Fatigue HRQL scores with no significant change from T0 to T1 and an increase of 7.9 points (p<0.01) in the score at T2. Those with higher steady state (T3) HRQL scores had higher HRQL scores during crisis. None of the remaining covariates, hospital site, age ,gender hydroxyurea use, and disease severity were associated with significant differences in HRQL scores over time. In the multivariate analysis of the specific HRQL SCD domain scores, there was significant improvement in 8 of the 9 HRQL domains. The greatest improvement in scores (parameter estimates) were noted in the pain and hurt (16.9), pain impact (15.3), and pain management (13.4) domains, p<0.01. The only domain where significant improvement was not noted was the Communication I domain (3.4). There was significant improvement in scores in all of the specific Fatigue HRQL domains, the General Fatigue (9.3) and Sleep/Rest Fatigue (9.6), and Cognitive Fatigue domains (5.0), p<0.01. This prospective study demonstrates that children with SCD have significantly lower HRQL at presentation of an acute VOC that improves by nearly 12 points one week post discharge. This is maintained at the steady state visit. The rate of change is not affected by hospital site, age, gender, hydroxyurea use, and disease severity. These findings provide the necessary data to tailor future interventions that aim to optimize HRQL for these patients. Disclosures No relevant conflicts of interest to declare.

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Patients Undergoing Shoulder Stabilization Procedures Do Not Accurately Recall Their Preoperative Symptoms at Short- to Midterm Follow-up

Orthopaedic Journal of Sports Medicine ◽

10.1177/2325967119851084 ◽

2019 ◽

Vol 7 (6) ◽

pp. 232596711985108

Author(s):

Danielle Hope ◽

Jacqui French ◽

Tania Pizzari ◽

Greg Hoy ◽

Shane Barwood

Keyword(s):

Shoulder Instability ◽

Intraclass Correlation ◽

Absolute Difference ◽

Minimal Detectable Change ◽

Shoulder Stabilization ◽

Specific Patient ◽

Younger Patients ◽

Significant Difference ◽

Patient Reported ◽

The Mean

Background: A patient’s ability to recall symptoms is poor in some elderly populations, but we considered that the recall of younger patients may be more accurate. The accuracy of recall in younger patients after surgery has not been reported to date. Purpose: To assess younger patients’ abilities to recall their preoperative symptoms after having undergone shoulder stabilization surgery. We used 2 disease-specific, patient-reported outcome measures (PROMs)—the Western Ontario Shoulder Instability Index (WOSI) and the Melbourne Instability Shoulder Score (MISS)—at a period of up to 2 years postoperatively. Study Design: Cohort study (diagnosis); Level of evidence, 2. Methods: Participants (N = 119) were stratified into 2 groups: early recall (at 6-8 months postoperatively; n = 58) and late recall (at 9-24 months postoperatively; n = 61). All patients completed the PROMs with instructions to recall preoperative function. The mean and absolute differences between the preoperative scores and recalled scores for each PROM were compared using paired t tests. Correlations between the actual and recalled scores of the subsections for each PROM were calculated using an intraclass correlation coefficient (ICC). The number of individuals who recalled within the minimal detectable change (MDC) of each PROM was calculated. Results: Comparison between the means of the actual and recalled preoperative scores for both groups did not demonstrate significant differences (early recall differences, MISS 1.05 and WOSI –38.64; late recall differences, MISS –0.25 and WOSI –24.02). Evaluation of the absolute difference, however, revealed a significant difference between actual and recalled scores for both the late and early groups (early recall absolute differences, MISS 12.26 and WOSI 216.71; late recall absolute differences, MISS 12.84 and WOSI 290.08). Average absolute differences were above the MDC scores of both PROMs at both time points. Subsections of each PROM demonstrated weak to moderate correlations between actual and recalled scores (ICC range, 0.17-0.61). Total scores for the PROMs reached moderate agreement between actual and recalled scores. Conclusion: Individual recall after shoulder instability surgery was not accurate. However, the mean recalled PROM scores of each group were not significantly different from the actual scores collected preoperatively, and recall did not deteriorate significantly over 2 years. This suggests that recall of the individual, even in this younger group, cannot be considered accurate for research purposes.

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Disparities After Discharge: The Association of Limited English Proficiency and Post-Discharge Patient Reported Issues

10.1101/2021.02.05.21251236 ◽

2021 ◽

Author(s):

Lev Malevanchik ◽

Margaret Wheeler ◽

Kristin Gagliardi ◽

Leah Karliner ◽

Sachin J. Shah

Keyword(s):

Outcome Measures ◽

Limited English Proficiency ◽

English Proficiency ◽

Care Transition ◽

Marginal Effect ◽

Post Discharge ◽

Clinical Issues ◽

Process Measures ◽

Patient Reported

AbstractBackgroundPatients with limited English proficiency (LEP) experience worse outcomes following hospital discharge. Care transition programs are common, yet little is known about the disparities in quality (process and outcome measures) experienced by patients with LEP.MethodsWe conducted a retrospective cohort study to determine the association of LEP and care transition quality at an urban, US academic hospital. We examined all adults discharge home from the hospital from May 2018 through April 2019. All patients received a multilingual, automated telephone call three days after discharge to assess and address patient-reported issues. We determined care transition quality using process measures (reach rate, time to resolve reported issue) and outcome measures (discharge instructions questions, difficulty obtaining prescriptions, medication concerns, follow up care questions, new or worsening symptoms, any other clinical issues). All results were adjusted for measured confounders; we used predicted probabilities and average marginal effect (AME) to describe associations.Results13,860 patients were included in the study; 11% had LEP. The program reached most patients regardless of LEP status but was less likely to reach patients with LEP (AME 3.3%; 95% CI, 1.4% to 5.1%). After adjustment, patients with LEP reported high rates of all measured patient-reported outcomes: discharge instruction (AME 4.8%; 95% CI, 2.7% to 6.9%), obtaining prescriptions (AME 2.9%; 95% CI, 0.6% to 5.1%), medications concerns (AME 2.3%; 95% CI, 0.0% to 4.6%), follow up questions (AME 2.8%; 95% CI, 0.3% to 5.3%), new or worsening symptoms (AME 3.2%; 95% CI, 0.7% to 5.8%), and any other clinical issues (AME 3.6%; 95% CI, 1.1% to 6.1%). When issues were identified, the association between LEP and time to resolution of an issue was statistically, but not clinically, significant.Conclusion and RelevanceAmong patients with LEP, substantial disparities exist in patient-reported post-discharge outcome measures indicating a need for better discharge processes that focus on quality and health equity. Following discharge, relatively minor disparities were observed in the processes of a care transitions program that supports non-English languages.

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Adaptation of the Connected Speech Test: Rerecording and Passage Equivalency

American Journal of Audiology ◽

10.1044/2019_aja-19-00052 ◽

2020 ◽

Vol 29 (2) ◽

pp. 259-264 ◽

Cited By ~ 2

Author(s):

Hasan K. Saleh ◽

Paula Folkeard ◽

Ewan Macpherson ◽

Susan Scollie

Keyword(s):

Speech Perception ◽

North American ◽

First Language ◽

Intraclass Correlation ◽

Normal Hearing ◽

Connected Speech ◽

Internal Reliability ◽

Speech Test ◽

The Mean ◽

Unit Standard

Purpose The original Connected Speech Test (CST; Cox et al., 1987) is a well-regarded and often utilized speech perception test. The aim of this study was to develop a new version of the CST using a neutral North American accent and to assess the use of this updated CST on participants with normal hearing. Method A female English speaker was recruited to read the original CST passages, which were recorded as the new CST stimuli. A study was designed to assess the newly recorded CST passages' equivalence and conduct normalization. The study included 19 Western University students (11 females and eight males) with normal hearing and with English as a first language. Results Raw scores for the 48 tested passages were converted to rationalized arcsine units, and average passage scores more than 1 rationalized arcsine unit standard deviation from the mean were excluded. The internal reliability of the 32 remaining passages was assessed, and the two-way random effects intraclass correlation was .944. Conclusion The aim of our study was to create new CST stimuli with a more general North American accent in order to minimize accent effects on the speech perception scores. The study resulted in 32 passages of equivalent difficulty for listeners with normal hearing.

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Anxiety, depression, fatigue, and headache burden in the pediatric hydrocephalus population

Journal of Neurosurgery Pediatrics ◽

10.3171/2020.4.peds19697 ◽

2020 ◽

Vol 26 (5) ◽

pp. 483-489 ◽

Cited By ~ 1

Author(s):

Kathrin Zimmerman ◽

Bobby May ◽

Katherine Barnes ◽

Anastasia Arynchyna ◽

Elizabeth N. Alford ◽

...

Keyword(s):

General Population ◽

Emotional Health ◽

Chronic Medical Condition ◽

Measurement Information ◽

Burden Of Headache ◽

Pediatric Hydrocephalus ◽

Patient Reported ◽

The Mean ◽

Moderate Range ◽

Anxiety Depression

OBJECTIVEChildhood hydrocephalus is a common chronic medical condition. However, little is known about the burden of headache and psychological comorbidities in children living with hydrocephalus. The purpose of this study was to determine the prevalence and severity of these conditions among the pediatric hydrocephalus population.METHODSDuring routine neurosurgery clinic visits from July 2017 to February 2018, the authors administered four surveys to children ages 7 years and older: Pediatric Migraine Disability Assessment (PedMIDAS), Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety, PROMIS Depression, and PROMIS Fatigue. The PedMIDAS is an assessment of headache disability in pediatric and adolescent patients. The PROMIS measures are pediatric self-reported instruments to assess social and emotional health. PROMIS measures utilize T-scores (mean 50, SD 10) to compare anxiety, depression, and fatigue in specific populations to those in the US general population. Clinical and demographic data were collected from the medical record (hydrocephalus etiology, shunt infection, race, etc.) and tested for associations with survey measure scores.RESULTSForty children completed the PedMIDAS. Ten percent of them were in the severe headache range, 5% were in the moderate range, and 5% were in the mild range. There was a statistically significant association between undergoing a cluster of shunt operations and headache burden (p = 0.003).Forty children completed all three PROMIS measures. The mean anxiety score was 45.8 (SD 11.7), and 2.5% of children scored in the severe anxiety range, 17.5% in the moderate range, and 20% in the mild range. The mean depression score was 42.7 (SD 10.0), with 2.5% of children scoring in the severe depression range, 5% in the moderate range, and 12.5% in the mild range. The mean fatigue score was 45.1 (SD 16.4), with 15% percent of children scoring in the severe fatigue range, 10% in the moderate range, and 7.5% in the mild range. There were no statistically significant associations between child anxiety, depression, or fatigue and clinical or demographic variables.CONCLUSIONSChildren with hydrocephalus have an average burden of headache, anxiety, depression, and fatigue as compared to the general population overall. Having a cluster of shunt operations correlates with a higher headache burden, but no clinical or demographic variable is associated with anxiety, depression, or fatigue.

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Validation of a menstrual pictogram and a daily bleeding diary for assessment of uterine fibroid treatment efficacy in clinical studies

Journal of Patient-Reported Outcomes ◽

10.1186/s41687-020-00263-0 ◽

2020 ◽

Vol 4 (1) ◽

Author(s):

Claudia Haberland ◽

Anna Filonenko ◽

Christian Seitz ◽

Matthias Börner ◽

Christoph Gerlinger ◽

...

Keyword(s):

Uterine Fibroid ◽

Full Range ◽

Intraclass Correlation ◽

Phase Iii ◽

Measurement Properties ◽

Retest Reliability ◽

Response Options ◽

Patient Global Impression ◽

Patient Reported ◽

Test Retest Reliability

Abstract Background To evaluate the psychometric and measurement properties of two patient-reported outcome instruments, the menstrual pictogram superabsorbent polymer-containing version 3 (MP SAP-c v3) and Uterine Fibroid Daily Bleeding Diary (UF-DBD). Test-retest reliability, criterion, construct validity, responsiveness, missingness and comparability of the MP SAP-c v3 and UF-DBD versus the alkaline hematin (AH) method and a patient global impression of severity (PGI-S) were analyzed in post hoc trial analyses. Results Analyses were based on data from up to 756 patients. The full range of MP SAP-c v3 and UF-DBD response options were used, with score distributions reflecting the cyclic character of the disease. Test-retest reliability of MP SAP-c v3 and UF-DBD scores was supported by acceptable intraclass correlation coefficients when stability was defined by the AH method and Patient Global Impression of Severity (PGI-S) scores (0.80–0.96 and 0.42–0.94, respectively). MP SAP-c v3 and UF-DBD scores demonstrated strong and moderate-to-strong correlations with menstrual blood loss assessed by the AH method. Scores increased in monotonic fashion, with greater disease severities, defined by the AH method and PGI-S scores; differences between groups were mostly statistically significant (P < 0.05). MP SAP-c v3 and UF-DBD were sensitive to changes in disease severity, defined by the AH method and PGI-S. MP SAP-c v3 and UF-DBD showed a lower frequency of missing patient data versus the AH method, and good agreement with the AH method. Conclusions This evidence supports the use of the MP SAP-c v3 and UF-DBD to assess clinical efficacy endpoints in UF phase III studies replacing the AH method.

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