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An evaluation of the Acromegaly Treatment Satisfaction Questionnaire (Acro-TSQ) in adult patients with acromegaly, including correlations with other patient-reported outcome measures: data from two large multicenter international studies.

ABSTRACT: PURPOSE:The Acromegaly Treatment Satisfaction Questionnaire (Acro-TSQ) is a new patient-reported outcome (PRO) measure for patients with acromegaly receiving injectable somatostatin analogs (SSAs) to assess clinical symptoms and adverse drug reaction interference, treatment satisfaction, and convenience. We evaluated its scale structure, reliability, validity, responsiveness, and what constitutes clinically meaningful change. METHODS:Data from two longitudinal studies (N?=?79 and 82) of patients receiving a stable injectable SSA dose for???6 months who completed the Acro-TSQ and other collateral measures (e.g., AcroQoL, AIS, WPAI:SHP, EQ-5D-5L) were analyzed. RESULTS:The first study demonstrated internal consistency of the Acro-TSQ. However, several items had high ceiling effects, responsiveness could not be established, and the minimally important difference (MID) was not estimable. In the second study, factor analysis revealed six scales: Symptom Interference, Treatment Convenience, Injection Site Interference, GI Interference, Treatment Satisfaction, and Emotional Reaction. Internal consistency and test-retest reliability were confirmed; most scales demonstrated significant differences in mean scores by disease severity. Correlations between Acro-TSQ scales and other collateral measures exceeded 0.30 in absolute value, confirming convergent validity. Responsiveness in Acro-TSQ scale scores reflected improved disease control. The MID was estimated for Symptom Interference (10-12 points), Treatment Convenience (9-11) and GI Interference (8-10). CONCLUSIONS:The Acro-TSQ is a brief, yet comprehensive tool to monitor important outcomes associated with injectable acromegaly SSA treatments. Its content reflects both disease and treatment burden as well as patient satisfaction, and its relevant for use in clinical studies.

SUBMITTER: Fleseriu M

PROVIDER: S-EPMC7316852 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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An evaluation of the Acromegaly Treatment Satisfaction Questionnaire (Acro-TSQ) in adult patients with acromegaly, including correlations with other patient-reported outcome measures: data from two large multicenter international studies.

Fleseriu Maria M Fogelfeld Leon L Gordon Murray B MB Sisco Jill J Crosby Ross D RD Ludlam William H WH Haviv Asi A Mathias Susan D SD

Pituitary 20200801 4

<h4>Purpose</h4>The Acromegaly Treatment Satisfaction Questionnaire (Acro-TSQ) is a new patient-reported outcome (PRO) measure for patients with acromegaly receiving injectable somatostatin analogs (SSAs) to assess clinical symptoms and adverse drug reaction interference, treatment satisfaction, and convenience. We evaluated its scale structure, reliability, validity, responsiveness, and what constitutes clinically meaningful change.<h4>Methods</h4>Data from two longitudinal studies (N = 79 and ...[more]

PMID: 32221764

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Project description:PURPOSE:Acromegaly is characterized by a broad range of manifestations. Early diagnosis is key to treatment success, but is often delayed as symptomatology overlaps with common disorders. We investigated sign-and-symptom associations, demographics, and clinical characteristics at acromegaly diagnosis. METHODS:Observational, cross-sectional, multicenter non-interventional study conducted at 25 hospital departments in France that treat acromegaly (ClinicalTrials.gov: NCT02012127). Adults diagnosed with acromegaly?<?5 years were enrolled. Demographic and clinical data were obtained from medical reports and patient questionnaires. Sign-and-symptom associations were assessed by multiple correspondence analysis (MCA). RESULTS:Overall, 472 patients were included in the analyses. MCA was unsuccessful in identifying sign-and-symptom associations at diagnosis. Endocrinologists (29.5% patients) and other clinical specialists (37.2% patients) were commonly first to suspect acromegaly. Morphologic manifestations (83.7-87.9% patients), snoring syndrome (81.4% patients), and asthenia (79.2% patients) were frequently present at diagnosis; differences were found between sexes for specific manifestations. Rates of discrepancy between patient- and physician-reported manifestations were highest for functional signs. Earliest manifestations prior to diagnosis, according to how they were detected, were enlarged hands and feet (6.4?±?6.8 and 6.2?±?6.9 years, functional signs), hypertension (6.6?±?7.5 years, complementary examination) and carpal/cubital tunnel syndrome (5.7?±?6.7 years, functional signs with complementary examination). CONCLUSIONS:Results confirm the broad range of manifestations at diagnosis and delay in recognizing the disease. We identified early manifestations and sex differences that may aid physicians in diagnosing acromegaly. Discrepancy rates suggest physicians should obtain the patient's perspective and seek functional signs during diagnosis.

Project description:Hospital-level measures of patient satisfaction and quality are now reported publically by the Centers for Medicare and Medicaid Services. There are limited metrics specific to cancer patients. We examined whether publically reported hospital satisfaction and quality data were associated with surgical oncologic outcomes. The Nationwide Inpatient Sample was utilized to identify patients with solid tumors who underwent surgical resection in 2009 and 2010. The hospitals were linked to Hospital Compare, which collects data on patient satisfaction, perioperative quality, and 30-day mortality for medical conditions (pneumonia, myocardial infarction [MI], and congestive heart failure [CHF]). The risk-adjusted hospital-level rates of morbidity and mortality were calculated for each hospital and the means compared between the highest and lowest performing hospital quartiles and reported as absolute reduction in risk (ARR), the difference in risk of the outcome between the two groups. All statistical tests were two-sided. A total of 63197 patients treated at 448 hospitals were identified. For patients at high vs low performing hospitals based on Hospital Consumer Assessment of Healthcare Providers and Systems scores, the ARR in perioperative morbidity was 3.1% (95% confidence interval [CI] = 0.4% to 5.7%, P = .02). Similarly, the ARR for mortality based on the same measure was -0.4% (95% CI = -1.5% to 0.6%, P = .40). High performance on perioperative quality measures resulted in an ARR of 0% to 2.2% for perioperative morbidity (P > .05 for all). Similarly, there was no statistically significant association between hospital-level mortality rates for MI (ARR = 0.7%, 95% CI = -1.0% to 2.5%), heart failure (ARR = 1.0%, 95% CI = -0.6% to 2.7%), or pneumonia (ARR = 1.6%, 95% CI = -0.3% to 3.5%) and complications for oncologic surgery patients. Currently available measures of patient satisfaction and quality are poor predictors of outcomes for cancer patients undergoing surgery. Specific metrics for long-term oncologic outcomes and quality are needed.

Project description:BackgroundIn Neonatal Intensive Care Units (NICUs), parent satisfaction and their experiences are fundamental to assess clinical practice and improve the quality of care delivered to infants and parents. Recently, a specific instrument, the EMpowerment of PArents in THe Intensive Care-Neonatology (EMPATHIC-N), has been developed in the Netherlands. This instrument investigated different domains of care in NICUs from a family-centered care perspective. In Italy, no rigorous instruments are available to evaluate parent satisfaction and experiences in NICU with family-centered care. The aim of this study was to translate and validate the EMPATHIC-N instrument into Italian language measuring parent satisfaction.MethodsA psychometric study was conducted in nine Italian NICUs. The hospitals were allocated across Italy: four in the North, four in Central region, one in the South. Parents whose infants were discharged from the Units were enrolled. Parents whose infants died were excluded.ResultsBack-forward translation was conducted. Twelve parents reviewed the instrument to assess the cultural adaptation; none of the items fell below the cut-off of 80% agreement. A total of 186 parents of infants who were discharged from nine NICUs were invited to participate and 162 parents responded and returned the questionnaire (87%). The mean scores of the individual items varied between 4.3 and 5.9. Confirmatory factor analysis was performed and all factor loadings were statistically significant with the exception of item 'Our cultural background was taken into account'. The items related to overall satisfaction showed a higher trend with mean values of 5.8 and 5.9. The Cronbach's alpha's (at domain level 0.73-0.92) and corrected item-total scale correlations revealed high reliability estimates.ConclusionsThe Italian EMPATHIC-N showed to be a valid and reliable instrument measuring parent satisfaction in NICUs from a family-centered care perspective. Indeed, it had good psychometric properties, validity, and reliability. Furthermore, this instrument is fundamental for further research and internationally benchmarking.

Project description:BackgroundOncology has been facing increasing outpatient activity associated with higher cancer incidence, better survival rates, and more treatment options. Innovative technological solutions could help deal with this increasing demand. Using digital patient-reported outcome measures (PROMs) to identify patients who need a face-to-face (FTF) appointment is a potential approach.ObjectiveThis study aims to assess the feasibility of digital PROM questionnaires to enable remote symptom monitoring for patients undergoing cancer treatment and their ability to highlight the requirement for an FTF appointment.MethodsThis study was performed at a tertiary oncology center between December 2018 and February 2019. The Common Terminology Criteria for Adverse Events were adapted into patient-friendly language to form the basis of treatment-specific digital questionnaires covering specific cancer drugs and radiotherapy treatments. These treatment-specific digital PROM questionnaires were scored by both patients and their clinicians during FTF appointments. Patients and clinicians did not see each other's scored PROMs. Agreement between patients and clinicians was assessed using descriptive statistics. Patient and staff feedback was also obtained.ResultsIn total, 90 patients participated in the study across 10 different treatment pathways. By comparing paired patient and clinician responses, the sensitivity of the patient-completed questionnaires in correctly highlighting the need for FTF review was 94% (44/47), and all patients with severe or grade 3+ symptoms were identified (6/6, 100%). Patient-completed PROMs appropriately revealed that 29% (26/90) of the participating patients did not need FTF review based on their symptoms alone. Certain oncological treatment pathways, such as immunotherapy, were found to have a larger proportion of patients with minimal symptoms than others, such as conventional chemotherapy. Patient and staff feedback showed high approval of digital PROMs and their potential for use in remote monitoring.ConclusionsDigital PROM questionnaires can feasibly highlight the need for FTF review in oncology clinics for treatment. Their use with specific treatments could safely reduce the requirement for FTF care, and future work should evaluate their application in the remote monitoring of patients.

Dataset Information

An evaluation of the Acromegaly Treatment Satisfaction Questionnaire (Acro-TSQ) in adult patients with acromegaly, including correlations with other patient-reported outcome measures: data from two large multicenter international studies.

Publications

An evaluation of the Acromegaly Treatment Satisfaction Questionnaire (Acro-TSQ) in adult patients with acromegaly, including correlations with other patient-reported outcome measures: data from two large multicenter international studies.

Similar Datasets

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