Patient-Reported Outcome Measure for Real-time Symptom Assessment in Women With Endometriosis: Focus Group Study.
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ABSTRACT: Background
Symptoms related to endometriosis have a significant impact on the quality of life, and symptoms often recur. The experience sampling method (ESM), a digital questioning method characterized by randomly repeated momentary assessments, has several advantages over traditionally used measurements, including the ability to assess the temporal relationship between variables such as physical, mental, and social factors.Objective
The aim of this study is to develop an ESM tool for patients with endometriosis to accurately measure symptoms and their course over time, allowing for personalized treatment and adequate monitoring of treatment efficacy in individual patients.Methods
On the basis of international guidelines, items from validated questionnaires were selected through a literature review and during focus groups and multidisciplinary expert meetings. Data analysis was conducted using ATLAS.ti (ATLAS.ti Scientific Software Development GmbH). The feasibility and usability of the newly developed momentary assessment tool were tested for 28 consecutive days in 5 patients with endometriosis-related pain symptoms.Results
Momentary assessment items contained questions concerning endometriosis symptoms, general somatic symptoms, psychological symptoms, contextual information, and the use of food and medication. A morning questionnaire on sleep and sexuality was included. In a pilot study, the patients considered the tool easy to use but time consuming. The average compliance rate of momentary assessments was 37.8% (106/280), with the highest completion rate during the first week (39/70, 56%). Therefore, it is advisable to use the ESM for a maximum of 7 days.Conclusions
A new digital tool for endometriosis symptom assessment was developed using the ESM, which may help overcome the limitations of current retrospective questionnaires. After validation and testing, future studies will be planned to evaluate the use of this tool in a clinical setting in order to propose a personalized treatment plan for women with endometriosis.
SUBMITTER: van Barneveld E
PROVIDER: S-EPMC8686475 | biostudies-literature |
REPOSITORIES: biostudies-literature
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| S-EPMC8585017 | biostudies-literature
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.
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Project description:ObjectivesThe Functional Dyspepsia Symptom Diary (FDSD) was developed to address the lack of symptom-focused, patient-reported outcome (PRO) measures designed for use in functional dyspepsia (FD) patients and meeting Food and Drug Administration recommendations for PRO instrument development.MethodsConcept elicitation interviews were conducted with FD participants to identify symptoms important and relevant to FD patients. A preliminary version of the FDSD was constructed, then completed by FD participants on an electronic device in cognitive interviews to evaluate the readability, comprehensibility, relevance, and comprehensiveness of the FDSD, and to preliminarily evaluate its measurement properties.ResultsDuring concept elicitation interviews, 45 participants spontaneously reported 19 symptom concepts. Of those, seven symptoms were selected for assessment by the eight-item FDSD. Cognitive interviews with 57 participants confirmed that participants were able to comprehend and provide meaningful responses to the FDSD, and that the handheld electronic FDSD format was suitable for use in the target population. Scores of the FDSD were well-distributed among response options, item discrimination indices suggested that the FDSD items differentiate among patients with varying degrees of FD severity, and inter-item correlations suggested that no items of the FDSD were capturing redundant information. Internal consistency estimates (0.87) and construct-related validity estimates using known-groups methods were within acceptable ranges.ConclusionsThe FDSD is a content-valid PRO measure, with preliminary psychometric evidence providing support for the FDSD's items and total score. Further psychometric evaluations are recommended to more fully test the FDSD's score performance and other measurement properties in the target patient population.
| S-EPMC5770596 | biostudies-literature
Project description:Background Chronic kidney disease (CKD) and kidney failure in childhood are associated with significant and life-altering morbidities and lower quality of life. Emerging evidence suggests that management should be guided in part by symptom burden; however, there is currently no standardized assessment tool for quantifying symptom burden in this pediatric population. This study aimed to develop and refine a patient-reported symptom assessment tool for children with CKD/kidney failure (PRO-Kid), to evaluate the frequency and impact of symptoms. Methods This was a prospective observational study of children and caregivers of children with CKD/kidney failure at two Canadian pediatric care centers. Building on previously published patient-reported outcome measures (PROs) for the assessment of symptom burden in other populations, we drafted a 13-item questionnaire. Cognitive interviews were performed with children and caregivers of children with CKD/kidney failure to iteratively refine the questionnaire. Results Twenty-four participants completed cognitive interviewing (11 children, 13 caregivers). The most common symptoms endorsed were feeling left out, feeling sad/depressed, inability to focus, tiredness, nausea, vomiting, not wanting to eat, and changes in the taste of food. Feeling left out was added to the questionnaire as almost all participants voiced this as a frequent and impactful symptom, resulting in a 14-item questionnaire. Conclusions PRO-Kid is the first pediatric CKD/kidney failure-specific PRO tool to assess symptom burden. Future work should validate this tool in a larger cohort so that it may be used to improve the care of children living with CKD/kidney failure. Graphical abstract A higher resolution version of the Graphical abstract is available as Supplementary information Supplementary Information The online version contains supplementary material available at 10.1007/s00467-021-05269-4.
| S-EPMC8579900 | biostudies-literature
Project description:Background Validity is the ability of an instrument to measure what it claims to measure. It means the degree to which the empirical evidence supports the trustworthiness of interpretations based on the calculated scores. The hematological malignancy (HM) specific patient reported outcome measure (HM-PRO), is a newly developed instrument for use in daily clinical practice as well as in research. This study, provides the evidence for construct validity of the HM-PRO, specifically focusing on the convergent and divergent validity compared to the other established instruments used in hematology. Methods This validation study adopted a prospective cross-sectional design where a heterogeneous group of patients diagnosed with different HMs and different disease state were recruited. A total of 905 patients were recruited from seven secondary care hospitals in the UK and online through five patient organizations. Patients were asked to complete the HM-PRO and other cancer specific PRO’s, FACT-G and EORTC QLQ C-30. Data analysis was performed using IBM SPSS 23 statistical software. Results A total of 486 males (53.7%) and 419 females (46.3%), with a mean age of 64.3 (± 12.4) years and mean time since diagnosis of 4.6 ( ± 5.2) were recruited. The total score of Part A of the HM-PRO highly correlated with the five functional scales of the EORTC QLQ-C30 (Physical = ?0.71, Role = ?0.72, Emotional = ?0.64, Cognitive = ?0.58, Social = ?0.74—p < 0.001). With respect to correlation with FACT-G, the total score of Part A of the HM-PRO highly correlated with Physical (?0.74), Emotional (?0.57), Functional (?0.66) domains and overall score of FACT-G (?0.74). Similarly, the total score of Part B of the HM-PRO highly correlated with three symptoms scales of EORTC QLQ-C30 (Fatigue scale = ?0.74, Nausea and Vomiting = ?0.52, Pain = ?0.59—p < 0.001) and individual symptom items (Dyspnea = 0.51, Insomnia= 0.43, Appetite loss = 0.54—p < 0.001). Conclusion The construct validity evidence presented in this research is a testimony to the HM-PRO’s ability to measure HRQoL issues which it intends to measure. This is of utmost importance when a PRO is used in routine clinical practice so that the interpretation of the scores or response to an individual item is understood by the clinicians/nurses as intended by the patients.
| S-EPMC7506039 | biostudies-literature
Project description:BACKGROUND:In the past years, a mobile health (mHealth) app called the Dutch Talking Touch Screen Questionnaire (DTTSQ) was developed in The Netherlands. The aim of development was to enable Dutch physical therapy patients to autonomously complete a health-related questionnaire regardless of their level of literacy and digital skills. OBJECTIVE:The aim of this study was to evaluate the usability (defined as the effectiveness, efficiency, and satisfaction) of the prototype of the DTTSQ for Dutch physical therapy patients with diverse levels of experience in using mobile technology. METHODS:The qualitative Three-Step Test-Interview method, including both think-aloud and retrospective probing techniques, was used to gain insight into the usability of the DTTSQ. A total of 24 physical therapy patients were included. The interview data were analyzed using a thematic content analysis approach aimed at analyzing the accuracy and completeness with which participants completed the questionnaire (effectiveness), the time it took the participants to complete the questionnaire (efficiency), and the extent to which the participants were satisfied with the ease of use of the questionnaire (satisfaction). The problems encountered by the participants in this study were given a severity rating that was used to provide a rough estimate of the need for additional usability efforts. RESULTS:All participants within this study were very satisfied with the ease of use of the DTTSQ. Overall, 9 participants stated that the usability of the app exceeded their expectations. The group of 4 average-/high-experienced participants encountered only 1 problem in total, whereas the 11 little-experienced participants encountered an average of 2 problems per person and the 9 inexperienced participants an average of 3 problems per person. A total of 13 different kind of problems were found during this study. Of these problems, 4 need to be addressed before the DTTSQ will be released because they have the potential to negatively influence future usage of the tool. The other 9 problems were less likely to influence future usage of the tool substantially. CONCLUSIONS:The usability of the DTTSQ needs to be improved before it can be released. No problems were found with satisfaction or efficiency during the usability test. The effectiveness needs to be improved by (1) making it easier to navigate through screens without the possibility of accidentally skipping one, (2) enabling the possibility to insert an answer by tapping on the text underneath a photograph instead of just touching the photograph itself, and (3) making it easier to correct wrong answers. This study shows the importance of including less skilled participants in a usability study when striving for inclusive design and the importance of measuring not just satisfaction but also efficiency and effectiveness during such studies.
| S-EPMC6789421 | biostudies-literature
Project description:BackgroundDegenerative cervical myelopathy (DCM) arises when arthritic changes of the cervical spine cause compression and a progressive injury to the spinal cord. It is common and potentially disabling. People with DCM have among the lowest quality of life scores (Short Form Health Survey-36 item [SF-36]) of chronic disease, although the drivers of the imapact of DCM are not entirely understood. DCM research faces a number of challenges, including the heterogeneous reporting of study data. The AO Spine Research Objectives and Common Data Elements for Degenerative Cervical Myelopathy (RECODE-DCM) project is an international consensus process that aims to improve research efficiency through formation of a core outcome set (COS). A key part of COS development process is organizing outcomes into domains that represent key aspects of the disease. To facilitate this, we sought to qualitatively explore the context and impact of patient-reported outcomes in DCM on study participants.ObjectiveThe goal of the research was to qualitatively explore the patient-reported outcomes in DCM to improve understanding of patient perspective and assist the organization of outcomes into domains for the consensus process.MethodsFocus group sessions were hosted in collaboration with Myelopathy.org, a charity and support group for people with DCM. A 40-minute session was audiorecorded and transcribed verbatim. Two authors familiarized themselves with the data and then performed data coding independently. Codes were grouped into themes and a thematic analysis was performed guided by Braun and Clarke's 6-phase approach. The themes were subsequently reviewed with an independent stakeholder with DCM, assisting in the process of capturing the true context and importance of themes.ResultsFive people with DCM (3 men and 2 women) participated in the focus group session. The median age was 53 years, and the median score on the modified Japanese Orthopaedic Association scale was 11 (interquartile range 9.5-11.5), indicating the participants had moderate to severe DCM. A total of 54 codes were reviewed and grouped into 10 potential themes that captured the impact of the disability on people with DCM: acceptance of symptoms, anticipatory anxiety, coping mechanisms/resilience, feelings of helplessness, financial consequences, lack of recognition, mental health impact, loss of life control, social reclusiveness and isolation, and social stigma.ConclusionsThis qualitative analysis of the perspectives of people with DCM has highlighted a number of prevailing themes currently unmeasured in clinical research or care. The determinants of low quality of life in DCM are currently unknown, and these findings provide a novel and so far, unique perspective. Continued inclusion of online communities and use of targeted digital software will be important in establishing a consensus-based COS for patients with DCM that is inclusive of all relevant stakeholders including people with DCM.
| S-EPMC7889422 | biostudies-literature
Project description:PurposeEndometriosis is a chronic disorder of the female reproductive system characterized by debilitating symptoms, particularly endometriosis-related pain (ERP). Patient-reported outcome (PRO) measures of symptoms and impacts are required to assess disease severity in ERP clinical studies and clinical practice. A content-valid instrument was developed by modifying the Dysmenorrhea Daily Diary (DysDD) to form the Endometriosis Daily Diary (EDD), an electronic PRO administered via handheld device.MethodsQualitative research with US females with ERP was conducted in three stages: (1) Development of an endometriosis conceptual model based on qualitative literature and conduct of concept elicitation (CE) interviews (N = 30). (2) Cognitive debriefing (CD) interviews (N = 30) conducted across two rounds to assess relevance and understanding of the EDD, with modifications between interview rounds. (3) Pilot testing to assess usability/feasibility of administrating the EDD daily on an electronic handheld device (N = 15). Clinical experts provided guidance throughout the study.ResultsThe conceptual model provided a comprehensive summary of endometriosis to inform modifications to the DysDD, forming the EDD. CD results demonstrated that EDD items were relevant for most participants. Instructions, items, response scales, and recall period were well-understood. The resulting daily diary assesses severity of cyclic and non-cyclic pelvic pain, dyspareunia, impact of ERP on functioning and daily life, symptoms associated with ERP, and bowel symptoms. Participants were able to complete the diary daily and found the device easy to use.ConclusionThe EDD demonstrated good content validity in females experiencing ERP. The next step is to perform psychometric validation in an ERP sample.
| S-EPMC8761214 | biostudies-literature
Project description:ObjectiveTo develop and validate a patient report outcome measure (PROM) for clinical practice that can monitor health status of patients with a range of musculoskeletal (MSK) disorders.MethodsConstructs for inclusion in the MSK-PROM were identified from a consensus process involving patients with musculoskeletal conditions, clinicians, purchasers of healthcare services, and primary care researchers. Psychometric properties of the brief tool, including face and construct validity, repeatability and responsiveness were assessed in a sample of patients with musculoskeletal pain consulting physiotherapy services in the United Kingdom (n=425).ResultsThe consensus process identified 10 prioritised domains for monitoring musculoskeletal health status: pain intensity, quality of life, physical capacity, interference with social/leisure activities, emotional well-being, severity of most difficult thing, activities and roles, understanding independence, and overall impact. As the EuroQol (EQ-5D-5L) is a widely adopted PROMs tool and covers the first four domains listed, to reduce patient burden to a minimum the MSK-PROM was designed to capture the remaining six prioritised domains which are not measured by the EQ-5D-5L. The tool demonstrated excellent reliability, construct validity, responsiveness and acceptability to patients and clinicians for use in clinical practice.ConclusionWe have validated a brief patient reported outcome measure (MSK-PROM) for use in clinical practice to measure musculoskeletal health status and monitor outcomes over time using domains that are meaningful to patients and sensitive to change. Further work will establish whether the MSK-PROM is useful in other musculoskeletal healthcare settings.
| S-EPMC4415910 | biostudies-literature
Project description:PurposePatient-reported outcome measures (PROMs) vary in their psycholinguistic complexity. This study examined whether response time to PROM items is related to psycholinguistic attributes of the item and/or the self-reported cognitive ability of the respondent.MethodsBaseline data from Wave 2 of the Quality of Life in Neurological Disorders (Neuro-QoL) development study were reanalyzed. That sample contained 581 adults with neurological disorders and whose self-reported cognitive abilities were quantified by the Neuro-QoL v2.0 Cognitive Function Item Bank. 185 Neuro-QoL items were coded for several psycholinguistic variables and design attributes: number of words and syllables, mean imageability of words, mean word frequency, mean age of word acquisition, and response format (e.g., about symptom frequency or task difficulty). Data were analyzed with linear and generalized linear mixed models.ResultsMain effects models revealed that slower response times were associated with respondents with lower self-reported cognitive abilities and with PROM items that contained more syllables, less imageable (e.g., more abstract) words, and that asked about task difficulty rather than symptom frequency. Interaction effects were found between self-reported cognition and those same PROM attributes such that people with worse self-reported cognitive abilities were disproportionately slow when responding to items that were longer (more syllables), contained less imageable words, and asked about task difficulty.ConclusionCompleting a PROM requires multiple cognitive skills (e.g., memory, executive functioning) and appraisal processes. Response time is a means of operationalizing the amount or difficulty of cognitive processing, and this report indicates several aspects of PROM design that relate to a measure's cognitive burden. However, future research with better experimental control is needed.
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