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Patterns of missing data in the use of the endometriosis symptom diary.

ABSTRACT: BACKGROUND:Endometriosis is a common, chronic condition in women of reproductive age that is characterized by the presence of functional endometriotic lesions outside the uterus. The Endometriosis Symptom Diary (ESD) is an electronic patient-reported outcome (ePRO) instrument that assesses women's experience of endometriosis symptoms, with pain scored using a 0-10 numeric rating scale. This study investigated patterns of data missing from the ESD in the VALEPRO study. METHODS:Post hoc analyses of missing data were conducted. RESULTS:Of 272 participants using the ESD, 26.5% had no missing diary entries, 46.7% had >?0-5% of entries missing, 13.2% had >?5-10% of entries missing and 13.6% had >?10% of entries missing over the entire study period. The duration of missing episodes (defined as ?1 consecutive days with missing diary entries) was generally short; most (81.4%) were 1 day. The difference in mean worst pain scores between missing and complete episodes per participant was -?0.1, suggesting that missing episodes were not related to severity of pain. Entries were significantly more likely to be missing on Fridays (18.5%) and Saturdays (22.9%) compared with other days of the week (p?

SUBMITTER: Seitz C

PROVIDER: S-EPMC5994094 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

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Patterns of missing data in the use of the endometriosis symptom diary.

Seitz Christian C Lanius Vivian V Lippert Susanne S Gerlinger Christoph C Haberland Claudia C Oehmke Frank F Tinneberg Hans-Rudolf HR

BMC women's health 20180608 1

<h4>Background</h4>Endometriosis is a common, chronic condition in women of reproductive age that is characterized by the presence of functional endometriotic lesions outside the uterus. The Endometriosis Symptom Diary (ESD) is an electronic patient-reported outcome (ePRO) instrument that assesses women's experience of endometriosis symptoms, with pain scored using a 0-10 numeric rating scale. This study investigated patterns of data missing from the ESD in the VALEPRO study.<h4>Methods</h4>Post ...[more]

PMID: 29884234

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Project description:BackgroundThe Endometriosis Symptom Diary (ESD) and Endometriosis Impact Scale (EIS) are patient-reported outcome measures developed to evaluate efficacy in clinical trials and clinical practice. The ESD is a daily electronic diary assessing symptom severity; the EIS is a weekly electronic diary assessing symptom impact. This study explored the importance of symptoms (ESD items) and impacts (EIS domains), perspectives on scoring algorithms, and clinically important difference (CID) thresholds to inform clinical trial score interpretation.MethodsEndometriosis patients in Germany (n?=?8) and the US (n?=?17), and expert clinicians (n?=?4) in Germany, the US, Spain, and Finland participated in semi-structured qualitative interviews comprising structured tasks. Interview transcripts were analyzed using thematic analysis techniques.ResultsQuality and severity of endometriosis-associated pelvic pain varied considerably among patients; some experienced pelvic pain daily, others during menstrual bleeding (dysmenorrhea) only. Patients and clinicians ranked "worst pelvic pain" as the most meaningful pain concept assessed by the ESD, followed by constant and short-term pelvic pain. Preferences for summarizing daily pain scores over the 28-day menstrual cycle depended on individuals' experience of pain: patients experiencing pain daily preferred scores summarizing data for all 28 days; patients primarily experiencing pain during selected days, and their treating clinicians preferred scores based on the most severe pain days. Initial CID exploration for the "worst pelvic pain" 0-10 numerical rating scale (0-10 NRS) revealed that, for most patients, a 2- or 3-point reduction was considered meaningful, depending on baseline severity. Patients and clinicians ranked "emotional well-being" and "limitations in physical activities" as the most important EIS domains.ConclusionsThis study informs the use of the ESD and EIS as clinically relevant measures of endometriosis symptoms and their impact. Findings from the ESD highlight the importance of individual-patient assessment of pain experience and identify "worst pelvic pain" as the most meaningful symptom assessed. Aggregating scores over the 28-day menstrual cycle may inform meaningful endpoints for clinical trials. Diverse EIS concepts (e.g. impact on emotional well-being and physical activities) are meaningful to patients and clinicians, emphasizing the importance of evaluating the impact on both to comprehensively assess treatment efficacy and decisions.Trial registrationNot applicable. Qualitative, non-interventional study; registration not required.

Project description:BackgroundEcological momentary assessment (EMA) is a set of research methods that capture events, feelings, and behaviors as they unfold in their real-world setting. Capturing data in the moment reduces important sources of measurement error but also generates challenges for noncompliance (ie, missing data). To date, EMA research has only examined the overall rates of noncompliance.ObjectiveIn this study, we identify four types of noncompliance among people who use drugs and aim to examine the factors associated with the most common types.MethodsData were obtained from a recent pilot study of 28 Nebraskan people who use drugs who answered EMA questions for 2 weeks. We examined questions that were not answered because they were skipped, they expired, the phone was switched off, or the phone died after receiving them.ResultsWe found that the phone being switched off and questions expiring comprised 93.34% (1739/1863 missing question-instances) of our missing data. Generalized structural equation model results show that participant-level factors, including age (relative risk ratio [RRR]=0.93; P=.005), gender (RRR=0.08; P=.006), homelessness (RRR=3.80; P=.04), personal device ownership (RRR=0.14; P=.008), and network size (RRR=0.57; P=.001), are important for predicting off missingness, whereas only question-level factors, including time of day (ie, morning compared with afternoon, RRR=0.55; P<.001) and day of week (ie, Tuesday-Saturday compared with Sunday, RRR=0.70, P=.02; RRR=0.64, P=.005; RRR=0.58, P=.001; RRR=0.55, P<.001; and RRR=0.66, P=.008, respectively) are important for predicting expired missingness. The week of study is important for both (ie, week 2 compared with week 1, RRR=1.21, P=.03, for off missingness and RRR=1.98, P<.001, for expired missingness).ConclusionsWe suggest a three-pronged strategy to preempt missing EMA data with high-risk populations: first, provide additional resources for participants likely to experience phone charging problems (eg, people experiencing homelessness); second, ask questions when participants are not likely to experience competing demands (eg, morning); and third, incentivize continued compliance as the study progresses. Attending to these issues can help researchers ensure maximal data quality.

Project description:Endometriosis is a common gynecological disorder that causes inflammation and pelvic pain. Endometriosis-related pain is best captured with patient-reported outcome (PRO) measures, however, assessment of endometriosis-related pain in clinical trials has been difficult in the absence of a reliable and valid PRO instrument. We describe the development of the Endometriosis Pain Daily Diary (EPDD), an electronic PRO developed as a survey instrument to assess endometriosis-related pain and its impact on patients' lives.The EPDD was initially developed on the basis of an existing Endometriosis Pain and Bleeding Diary, a targeted review of relevant literature, clinical expert interviews, and open-ended (concept elicitation) patient interviews in the United States (US) and Japan which captured patients' experience with endometriosis. Cognitive interviews of patients with endometriosis were conducted to evaluate patient comprehension of the EPDD items. A conceptual model of endometriosis was developed, and meetings with US and European regulatory authorities provided feedback for validating the EPDD in the context of clinical trials. Translatability assessments of the EPDD were conducted to confirm its appropriate interpretation and ease of completion across 17 languages.The iterative development progressed through three versions of the instrument. The EPDDv1 included 18 items relating to dysmenorrhea/pelvic pain, dyspareunia and sexual activity, bleeding, hot flashes, daily activities, and use of rescue medication. The EPDDv2 was a larger 43-item survey tested in cognitive interviews and subsequently revised to yield the current 11-item EPDDv3, consisting of five core items relating to dysmenorrhea, non-menstrual pelvic pain, and dyspareunia, and six extension items relating to sexual activity, daily activities, and use of rescue medication.The EPDD is a PRO for the evaluation of endometriosis-related pain and its associated impacts on patients' lives. The EPDD represents an important step in providing a PRO that is relevant to patients with endometriosis-related pain in the context of a clinical study setting (ie, fit-for-purpose), designed to evaluate pain associated with endometriosis, including regulatory agency support for its further exploration in clinical trials.

Dataset Information

Patterns of missing data in the use of the endometriosis symptom diary.

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Patterns of missing data in the use of the endometriosis symptom diary.

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