7-day Recall Period Research Articles

Qualitative and psychometric approaches to evaluate the PROMIS pain interference and sleep disturbance item banks for use in patients with rheumatoid arthritis

BackgroundPatients with rheumatoid arthritis (RA) commonly experience pain despite the availability of disease-modifying treatments. Sleep disturbances are frequently reported in RA, with pain often a contributing factor. The Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference and Sleep Disturbance item banks were initially developed to provide insights into the patient experience of pain and sleep, respectively, though they were not specifically intended for use in RA populations. This study evaluated the content validity of the PROMIS Pain Interference and Sleep Disturbance item banks in RA and identified relevant content for short forms for patients with RA that achieved high measurement precision across a broad range of health.MethodsA qualitative approach consisting of hybrid concept elicitation and cognitive debriefing interviews was used to evaluate the content validity of the item banks in RA. Interviews were semi-structured and open-ended, allowing a range of concepts and responses to be captured. Findings from the qualitative interviews were used to select the most relevant items for the short forms, and psychometric evaluation, using existing item-response theory (IRT) item parameters, was used to evaluate the marginal reliability and measurement precision of the short forms across the range of the latent variables (i.e. pain interference and sleep disturbance).ResultsThirty-two participants were interviewed. Participants reported that RA-related pain and sleep disturbances have substantial impacts on their daily lives, particularly with physical functioning. The PROMIS Pain Interference and Sleep Disturbance item banks were easy to understand and mostly relevant to their RA experiences, and the 7-day recall period was deemed appropriate. Qualitative and IRT-based approaches identified short forms for Pain Interference (11 items) and Sleep Disturbance (7 items) that had high relevance and measurement precision, with good coverage of the concepts identified by participants during concept elicitation.ConclusionPain and sleep disturbances affect many aspects of daily life in patients with RA and should be considered when novel treatments are developed. This study supports the use of the PROMIS Pain Interference and Sleep Disturbance item banks in RA, and the short forms developed herein have the potential to be used in clinical studies of RA.

Comparing Food Security Before and During the COVID-19 Pandemic: Considerations When Choosing Measures

Comparing Food Security Before and During the COVID-19 Pandemic: Considerations When Choosing Measures

P116 Development of a new patient-reported outcome measure for patients with complex cryptoglandular fistulas

Abstract Background Complex cryptoglandular fistulas (CCF) arise from infected anal glands and are often associated with substantial morbidity and healthcare utilization. Standarized patient-reported outcome measures (PROMs) for CCF are lacking. Thus, we aimed to develop a disease-specific PROM to assess the burden of symptoms and their impact on daily life in patients with CCF. Methods To develop a conceptual model, a targeted literature review was conducted to identify symptoms and impacts on daily life associated with CCF. Existing PROMs relating to anal fistulas were also sought. Semi-structured interviews with colorectal surgeons (n=5) assessed clinical perspectives on patient experience of CCF. A draft item pool was developed based on the refined conceptual model and using the Quality of Life in Patients with Anal Fistula Questionnaire as a reference. The tool was refined through concept elicitation interviews on the symptoms and impacts of CCF, and cognitive debriefing on the interpretation, understanding and response to each item. Interviews were conducted until concept saturation was achieved and patient feedback suggested no further refinements were required. Results The literature review identified discharge, pain, faecal incontinence and bleeding as the most prevalent symptoms, and embarrassment as the most prevalent impact on daily life. Results from surgeon interviews were then used to revise the initial conceptual model. Twenty US adults (60% female; mean age, 49 years) with clinically confirmed CCF participated in interviews (four waves of n=5). Patients identified 10 salient symptoms and 11 salient impacts on daily life (salient defined as mention by ≥50% of patients and mean disturbance rating ≥5 on a 10-point scale). The final conceptual model included the main symptoms and treatment-related effects, and impacts on daily life. The draft item pool was refined, resulting in a final PROM consisting of 14 items (covering frequency and severity) relating to symptom domains – discharge, incontinence, pain, irritation, odour, abscess – and 6 items relating to health-related quality of life domains – functional, physical, psychological, social health. The PROM features a 7-day recall period, with responses mostly given on a 5-point verbal rating scale. Cognitive debriefing confirmed that the PROM was clear, easy to understand and relevant to patients’ experiences. Conclusion The 20-item CCF questionnaire (CCFQ-20) is a new PROM that has been developed and tested for content validity, following expert guidance and regulatory best practices. It addresses a comprehensive set of salient symptoms and impacts experienced by patients with CCF. Psychometric testing is required to fully evaluate this PROM. Sponsor: Takeda Pharmaceuticals USA, Inc.

Development of a Core Outcome Set for Therapeutic Studies in Eosinophilic Esophagitis (COREOS): An International Multidisciplinary Consensus

Development of a Core Outcome Set for Therapeutic Studies in Eosinophilic Esophagitis (COREOS): An International Multidisciplinary Consensus

Qualitative study: burden of menopause-associated vasomotor symptoms (VMS) and validation of PROMIS Sleep Disturbance and Sleep-Related Impairment measures for assessment of VMS impact on sleep

PurposeWe evaluated the impact of menopause-associated vasomotor symptoms (VMS) on sleep. We also sought to establish the content validity of Patient-Reported Outcomes Measurement Information System (PROMIS) short form Sleep-Related Impairment and Sleep Disturbance measures in postmenopausal women with moderate to severe VMS.MethodsCross-sectional, in-person, qualitative interviews were conducted in the United States (Texas, Illinois) and European Union (UK, France) with women aged 40–64 years experiencing moderate to severe VMS (≥35/wk). Main outcomes were impact of VMS on sleep based on concept elicitation and content validity of PROMIS Sleep-Related Impairment and Sleep Disturbance short forms via cognitive debriefing.ResultsThirty-two women (US: n = 16; EU: n = 16) participated. A majority (US: 93.8%; EU: 93.8%) said VMS affected sleep; specifically, they had sleep interrupted by sweating or overheating and had difficulty returning to sleep. Sleep disturbance was the most bothersome aspect of VMS (US: 75%; EU: 50%). VMS-associated sleep disturbance affected next-day work productivity, mood, relationships, daily activities, concentration, social activities, and physical health. Participants found both PROMIS sleep measures relevant and easy to answer; the Sleep Disturbance measure was considered the most relevant. Participants had no difficulty remembering their experiences over the 7-day recall period and found the response options to be distinct.ConclusionVMS associated with menopause significantly interferes with sleep and next-day functioning (e.g., work productivity), supporting assessment of sleep outcomes in studies evaluating treatment of VMS. Women with moderate to severe VMS found that the PROMIS Sleep-Related Impairment and Sleep Disturbance short forms assessed constructs important to understanding sleep in the context of menopause-associated VMS.

Coping or adapting? Experiences of food and nutrition insecurity in specialised fishing households in Komodo District, eastern Indonesia

BackgroundThere is growing recognition of the need for fish to be better integrated into nutrition-sensitive strategies for addressing malnutrition. Fish are overwhelmingly produced by the small-scale sector, which supports food and nutrition security directly through the provision of fish and indirectly through the generation of income which can be used to purchase other desired foods. However, there has been relatively little research on the extent of food and nutrition security in specialised fishing communities. This study assessed food and nutrition security among households in specialised fishing communities in Komodo District, eastern Indonesia.MethodsWe assessed the seasonal nutrition quality of household diets using the Food Consumption Score for nutritional analysis and food insecurity using the Household Food Insecurity Access Scale in 66 households across three communities, using a modified cluster sampling strategy. We calculated and generated descriptive statistics for these indicators with Microsoft Excel and ran a logistic generalized linear mixed model to determine factors associated with severe food insecurity using SPSS. We used semi-structured interviews and focus group discussions to understand perceptions of, change over time, and strategies for dealing with food shortfalls.ResultsWhile most households have acceptable access to nutritious foods, especially protein and heme iron-rich foods, nearly one half of households consumed vitamin A rich foods on less than 3 days of the 7-day recall period in either season. More than half of households reported experiencing a moderate or severe level of food insecurity, with higher food insecurity in the wet season. Low maternal education (OR: 3.8, 95%CI 1.5–9.9) and lower household wealth (OR: 0.5, 95%CI 0.3–0.9) were found to be associated with a severe level of food insecurity. Household’s consumptive and non-consumptive response strategies reflect adaptation to chronic food insecurity but are nutritionally and economically unsustainable.ConclusionHouseholds in specialised fishing communities in Komodo District consumed diets with low diversity and experienced high levels of food insecurity. There is a need for culturally-appropriate nutrition-sensitive strategies to enhance food and nutrition security in vulnerable fishing communities.

Development and content validation of the Pediatric Oral Medicines Acceptability Questionnaires (P-OMAQ): patient-reported and caregiver-reported outcome measures

BackgroundEvolving regulatory guidelines recommend routine assessment of the acceptability of pediatric oral medicines throughout clinical development processes. However, such assessment is problematic owing to a lack of standard methods or criteria that define acceptability for children and their caregivers. This research aimed to identify the attributes of acceptability for targeted oral formulation types that are important to children, and to develop content-valid patient- and caregiver-reported outcome acceptability measures for use in the context of clinical drug development.MethodsA concept-focused literature review and two advisory panel meetings involving researchers, clinicians, and measurement scientists were conducted to identify acceptability attributes that may be relevant to children taking targeted oral medicine formulations. The Pediatric Oral Medicines Acceptability Questionnaires (P-OMAQs), including patient (P-OMAQ-P) and caregiver (P-OMAQ-C) versions, were drafted to assess these attributes. Qualitative concept elicitation (CE) and cognitive debriefing (CD) patient and caregiver interviews were conducted to confirm key acceptability attribute concepts for measurement and to evaluate patient and caregiver ability to understand and respond to the questions.ResultsA full-text review of 40 articles identified 24 acceptability attributes that were categorized into 10 overarching domains and organized into a preliminary conceptual model. Feedback from the advisory panel refined the preliminary model. In total, 14 attributes were reported during the CE phase of the interviews (n = 23 pediatric patients, n = 13 caregivers); six attributes were included in the final model. The draft P-OMAQ was refined over four waves of CD interviews (n = 31 pediatric patients, n = 48 caregivers). The final version of the P-OMAQ-P is a 12-item questionnaire designed for young people aged 8–17 years. The P-OMAQ-C is a 19-item questionnaire designed for adult caregivers of young people aged 6 months to 17 years. There are two versions of each questionnaire: one with a 24-h recall period and one with a 7-day recall period. All items are answered on a 5-point numerical rating scale.ConclusionsThis research supports the content validity of the patient and caregiver versions of the P-OMAQ. Both questionnaires appropriately assess the acceptability of oral medicine formulations from the perspective of pediatric patients and their caregivers.

Methodological considerations when measuring oral health-related quality of life.

Dental patient-reported outcomes (dPROs) and their measures, dPROMs, are fundamental for evidence-based dentistry. However when selecting, applying and evaluating an instrument with a focus on OHRQoL assessment for adults, several methodological considerations are essential to derive valid and meaningful results. In this review article, criteria for selecting the appropriate OHRQoL instrument, aspects of administering the instrument and how to evaluate resulting scores of single and multiple assessments are presented and critically assessed. Oral disease-generic and dimension-generic instruments capturing the entire construct OHRQoL allow for best comparability of findings across different diseases, settings and populations, with the Oral Health Impact Profile (OHIP) being the most often used and methodologically best investigated one. It is available in several versions with the 5-item version being the one with the lowest burden for the patient. Responses are given on a 5-point ordinal rating scale, the recommended response scale for dPROMs. A 7-day recall period allows for assessment of short-term effects. Clinically relevant effects of item or instrument order or administration method on OHIP scores do not seem to be likely. OHIP summary and dimension scores can be compared to norms from general population or different patient populations. Change scores should be set into context with the minimal important difference of the instrument. OHIP-5 has greatest potential to be used across all settings for assessment and evaluation of OHRQoL in adults. It allows a comprehensive characterising of patients suffering from oral diseases and of this impact using OHRQoL dimensions.

539 Validation of the PROMIS Itch Questionnaire – itch severity assessments in adults with atopic dermatitis

Little is known about the validity of numeric and verbal rating scales (NRS and VRS) for itch and itch frequency for assessing itch severity in atopic dermatitis (AD). We evaluated the Patient-Reported Outcomes Information System (PROMIS®) Itch Questionnaire (PIQ) – itch severity assessment, including multiple NRS, VRS and frequency of itch assessments assessing a 7-day recall period, in adults with AD and compared their performance. Self-administered questionnaires and skin-examination were performed in 410 AD patients (age 18-90 years) in a dermatology practice setting. PIQ NRS, VRS and frequency of itch had good content validity; strong correlations with each other (Spearman correlations, P<0.0001) and weak-moderate correlations with POEM, EASI, objective-SCORAD, and DLQI (P<0.0001); and very good discriminant validity. Changes from baseline in NRS, VRS and frequency of itch were moderately to strongly correlated with each other, weakly to moderately correlated with other patient-reported (POEM, SCORAD-itch, DLQI) and clinical-reported outcomes (EASI, objective-SCORAD).There were no floor or ceiling effects for NRS or VRS itch, but there were ceiling effects for itch frequency. Each assessments was completed in <1 minute by all patients. In conclusion, NRS, VRS and frequency of itch from PIQ – itch severity showed good content and construct validity, and/or responsiveness in adults with AD, and were feasible for use in clinical trials and practice.

Market Access, Production Diversity, and Diet Diversity: Evidence From India.

Recent literature, largely from Africa, shows mixed effects of own-production on diet diversity. However, the role of own-production, relative to markets, in influencing food consumption becomes more pronounced as market integration increases. This paper investigates the relative importance of two factors - production diversity and household market integration - for the intake of a nutritious diet by women and households in rural India. Data analysis is based on primary data from an extensive agriculture-nutrition survey of 3600 Indian households that was collected in 2017. Dietary diversity scores are constructed for women and households is based on 24-hour and 7-day recall periods. Household market integration is measured as monthly household expenditure on key non-staple food groups. We measure production diversity in two ways - field-level and on-farm production diversity - in order to account for the cereal centric rice-wheat cropping system found in our study locations. The analysis is based on Ordinary Least Squares regressions where we control for a variety of village, household, and individual level covariates that affect food consumption, and village fixed effects. Robustness checks are done by way of using a Poisson regression specifications and 7-day recall period. Conventional measures of field-level production diversity, like the number of crops or food groups grown, have no significant association with diet diversity. In contrast, it is on-farm production diversity (the field-level cultivation of pulses and on-farm livestock management, and kitchen gardens in the longer run) that is significantly associated with improved dietary diversity scores, thus suggesting the importance of non-staples in improving both individual and household dietary diversity. Furthermore, market purchases of non-staples like pulses and dairy products are associated with a significantly higher dietary diversity. Other significant determinants of dietary diversity include women's literacy and awareness of nutrition. These results mostly remain robust to changes in the recall period of the diet diversity measure and the nature of the empirical specification. This study contributes to the scarce empirical evidence related to diets in India. Additionally, our results indicate some key intervention areas - promoting livestock rearing, strengthening households' market integration (for purchase of non-staples) and increasing women's awareness about nutrition. These are more impactful than raising production diversity.

Development of the PROMIS Pediatric Physical Activity Item Banks.

The purpose of this study was to develop self-report and parent-proxy measures of children's physical activity for clinical research and practice and to demonstrate a valid and reliable instrument of children's lived experience of physical activity as reported by the children themselves or their parent proxies. This study involved qualitative development of item pools followed by 2 cross-sectional validity and reliability studies. The National Institutes of Health Patient Reported Outcome Measurement Information System (PROMIS) instrument development standards were applied to create child self-report and parent-proxy physical activity instruments from previously developed, content-valid pools of physical activity items. Each item used a 7-day recall period and had 5 response options. Item bank calibration was based on national samples totaling 3033 children aged 8 to 17years and 2336 parents of children aged 5 to 17years. Quantitative analyses included reliability assessments, factor analyses, item response theory calibration, differential item functioning, and construct validation. The final item banks comprised 10 items each. The items were selected based on content and psychometric properties. The item banks appeared to be unidimensional and free from differential item functioning. They showed excellent reliability and a high degree of precision across the range of the latent variable. Child-report and parent-proxy 4- and 8-item fixed-length instruments were specified. The instruments showed moderate correlation with existing self-report measures of physical activity. The PROMIS Pediatric Physical Activity instruments provide precise and valid measurement of children's lived experiences of physical activity. The availability of the PROMIS Pediatric Physical Activity instruments will support advances in clinical practice and research that require measurement of pediatric physical activity by self- and parent-proxy report.

Using consumer-friendly wearables to correlate patient and technology-reported physical activity in healthy seniors

Abstract A leading risk factor for chronic disease is physical inactivity. In efforts to assess physical activity and inform designs for prevention, health professionals currently use inexpensive, but subjective validated scales, or objective, but expensive research-grade wearables. In the meanwhile, individuals increasingly use affordable consumer-friendly wearable devices that can objectively monitor behaviours while daily life unfolds. However, the relationships between their outcomes and the validated scales are yet to be calibrated. We report our results from a study on 31 seniors from Hungary and Spain (mean age 70.6 +/- 3.2). Our study quantified the relations between physical activity outcomes, as patient-reported through 53 answers (1.71 +/- 0.96 / person) on the International Physical Activity Questionnaire (IPAQ) with a 7-day recall period, and 5615 days (mean 181.1 +/- 179.2 days collected / person) technology-reported by Fitbit Charge 2. The wearables monitored daily life behaviours of physical activity and sleep for long durations (7 to 120 days). We found strong Spearman correlations between light and moderate IPAQ physical activity in the domestic activity domain, and light-fair intensity Fitbit physical activity (e.g., rS = 0.88, p

Burden of illness in not adequately controlled chronic hypoparathyroidism: Findings from a 13-country patient and caregiver survey.

ObjectiveTo address knowledge gaps regarding burdens associated with not adequately controlled chronic hypoparathyroidism.DesignGlobal patient and caregiver survey.Study PopulationsPatients with chronic hypoparathyroidism not adequately controlled on conventional therapy and their caregivers.MeasurementsHealth‐related quality of life (HRQoL) and health status were evaluated using the 36‐item Short Form version 2 (SF‐36 v2.0) and Five‐Level EuroQoL 5 Dimensions (EQ‐5D‐5L) instruments, respectively. Hypoparathyroidism‐associated symptoms were assessed by a disease‐specific Hypoparathyroidism Symptom Diary and caregiver burden via the Modified Caregiver Strain Index (MCSI).ResultsData were obtained from 398 patients and 207 caregivers. Patients' self‐rated hypoparathyroidism‐related symptom severity was none (3%), mild (32%), moderate (53%) or severe (12%). Per the Hypoparathyroidism Symptom Diary, patients reported moderate, severe or very severe symptoms of physical fatigue (73%), muscle cramps (55%), heaviness in limbs (55%) and tingling (51%) over a 7‐day recall period. Impacts (rated ‘somewhat’ or ‘very much’) were reported by 84% of patients for ability to exercise, 78% for sleep, 75% for ability to work and 63% for family relationships. Inverse relationships were observed between patient self‐rated overall symptom severity and HRQoL and health status assessment scores—the greater the symptom severity, the lower the SF‐36 and EQ‐5D‐5L scores. Caregiver burden increased with patient self‐rated symptom severity: none, 1.7 MCSI; mild, 5.4 MCSI; moderate, 9.5 MCSI; and severe, 12.5 MCSI.ConclusionPatients with not adequately controlled hypoparathyroidism reported substantial symptoms and impacts. Greater patient symptom severity was associated with decreased patient HRQoL and health status assessments and increased caregiver burden.

Reliability and Validity of the Modified 7-Day Lee Chronic Graft-versus-Host Disease Symptom Scale.

Chronic graft-versus-host disease (cGVHD) adversely affects patient quality of life, functional status, and survival after allogenic hematopoietic cell transplantation. The Lee Symptom Scale is a 30-item scale developed to measure the symptoms of cGVHD. Although the original 30-item scale uses a 1-month recall period, we tested the reliability and validity of a 28-item scale (deleting 2 items based on supportive care needs rather than symptoms) with a 7-day recall period, a format that is more appropriate for use in clinical trials. Results show the modified 7-day scale is reliable and valid in the modern era and may be used to assess the symptom burden of cGVHD in clinical trials. Using the distribution method, a 5- to 6-point difference (half a standard deviation) is considered clinically meaningful.

Does recall period matter? Comparing PROMIS® physical function with no recall, 24-hr recall, and 7-day recall.

To evaluate the influence of recall periods on the assessment of physical function, we compared, in cancer and general population samples, the standard administration of PROMIS Physical Function items without a recall period to administrations with 24-hour and 7-day recall periods. We administered 31 items from the PROMIS Physical Function v2.0 item bank to 2400 respondents (n = 1001 with cancer; n = 1399 from the general population). Respondents were randomly assigned to one of three recall conditions (no recall, 24-hours, or 7-days) and one of two "reminder" conditions (with recall periods presented only at the start of the survey or with every item). We assessed items for potential differential item functioning (DIF) by recall time period. We then tested recall and reminder effects with analysis of variance controlling for demographics, English fluency, and co-morbidities. Based on conservative pre-set criteria, no items were flagged for recall time period-related DIF. Using analysis of variance, each condition was compared to the standard PROMIS administration for Physical Function (no recall period). There was no evidence of significant differences among groups in the cancer sample. In the general population sample, only the 24-hour recall condition with reminders was significantly different from the "no recall" PROMIS standard. At the item level, for both samples, the number of items with non-trivial effect size differences across conditions was minimal. Compared to no recall, the use of a recall period has little to no effect upon PROMIS physical function responses or scores. We recommend that PROMIS Physical Function be administered with the standard PROMIS "no recall" period.

Dietary Diversity Measures Derived from Food Frequency Methods Are Weak Proxies for Anthropometric Indicators of Child Nutrition in East Africa (P11-111-19)

ObjectivesThe 7-item child dietary diversity score (DDS) is used widely as a metric of dietary diversity (DD) for infant and young child feeding (IYCF) in low-middle income countries. Validation of the DDS was based on mean micronutrient density adequacy and not other measures of child nutrition. We aimed to develop a measure of DD more strongly associated with anthropometric indicators of child nutrition. MethodsWe used data from two Tanzanian surveys, IMMANA (n = 88; ages 6–23 mo.) and the Demographic and Health Survey (DHS) (n = 9,156; ages 6–59 mo.), and two Kenyan surveys, MAMA SASHA (n = 384; age 6–12 mo.) and DHS (n = 17,509; ages 6–59 mo.). For each survey, we calculated the DDS, minimum DD, a score using all 15 items found in the standard DHS, and a yes/no indicator of animal source food (ASF) consumption. In IMMANA and MAMA SASHA, we also used a count of all unique food items consumed and based each measure on both 24-hr and 7-day recall periods. Outcome indicators were stunting, wasting, and underweight as defined by WHO. We evaluated the performance of each DD measure in identifying child undernutrition by comparing the area under the ROC curve (AUC), and estimating odds ratios using logistic regression methods. AUC = 50% is no better than random assignment. Complex survey procedures were used in all analyses and alpha was set at 0.05. ResultsIn the DHS and MAMA SASHA data, all measures of DD had similar AUC values that did not exceed 61% when compared to the anthropometric indicators. In the IMMANA data, no measure exceeded 70% AUC for wasting, 64% for underweight, or 58% for stunting. For most DD measures, increasing the recall period to 7 days marginally improved its AUC (< 3%), while it decreased the AUC for wasting in the IMMANA data. The ASF indicator had a similar AUC to the DDS. In the Tanzania DHS, a higher DD, by all four measures, was associated with decreased odds of stunting, wasting, and underweight. In contrast, no measure of DD was associated with growth indicators for Kenya. The DD indicators based on the 15-item list and the count of unique foods were negatively associated with odds of wasting in the IMMANA data. ConclusionsIn two east African settings, measures of DD derived from existing food frequency questionnaires were weak proxies for measures of child undernutrition based on anthropometry. Funding SourcesInnovative Methods and Metrics for Agriculture and Nutrition Actions.

Development and adaptation of patient-reported outcome measures for patients who experience itch associated with primary biliary cholangitis

PurposeTo conduct qualitative interviews to evaluate and refine the Itch Diary (ID) and weekly version of the PBC-40 in patients with itching associated with primary biliary cholangitis (PBC).MethodsTwenty adults with self-reported PBC diagnoses and recent/ongoing itching of at least moderate intensity participated in face-to-face qualitative combined concept elicitation (CE) interviews and cognitive interviews after completing the morning and evening versions of the ID and weekly version of the PBC-40. These questionnaires were evaluated to confirm saturation of concepts of interest and cognitively test the English language versions of the measures in patients with PBC in the US and Canada. Transcripts were organized into descriptions of PBC-related symptoms and symptom-related impacts using a structured coding framework. Two waves of interviews were conducted; revisions made after wave 1 were further tested in wave 2.ResultsInterview results confirmed the relevance of concepts presented in the PBC-40 and ID to patients’ experiences. Saturation of concept was achieved. Itching-related signs and symptoms (46%) were the most commonly expressed symptom concept in the CE interviews followed by energy-related (14%) and additional signs/symptoms (13%). Several changes to the ID were made in response to cognitive interview results. Changes to the PBC-40 included adaptations from British to North American English, and the appropriateness of a 7-day recall period was confirmed.ConclusionsRelevance of the symptom and impact concepts in the ID to measure PBC-related itch were confirmed. Adaptation of the PBC-40 to a weekly recall period and for North American English was successful.

Comparison of 3-day and 7-day recall periods for food consumption reference values in foodborne disease outbreak investigations.

Investigations into an outbreak of foodborne disease attempt to identify the source of illness as quickly as possible. Population-based reference values for food consumption can assist in investigation by providing comparison data for hypothesis generation and also strengthening the evidence associated with a food product through hypothesis testing. In 2014-2015 a national phone survey was conducted in Canada to collect data on food consumption patterns using a 3- or 7-day recall period. The resulting food consumption values over the two recall periods were compared. The majority of food products did not show a significant difference in the consumption over 3 days and 7 days. However, comparison of reference values from the 3-day recall period to data from an investigation into a Salmonella Infantis outbreak was shown to support the conclusion that chicken was the source of the outbreak whereas the reference values from a 7-day recall did not support this finding. Reference values from multiple recall periods can assist in the hypothesis generation and hypothesis testing phase of foodborne outbreak investigations.

PCN366 - QUALITATIVE PATIENT INTERVIEWS TO SUPPORT THE FACT HEPATOBILIARY SYMPTOM INDEX-8 AMONG PATIENTS WITH HEPATOCELLULAR CARCINOMA AND ELEVATED BASELINE ALPHA-FETOPROTEIN

The FACT Hepatobiliary Symptom Index 8 (FHSI-8) is a patient-reported questionnaire that assesses priority symptoms identified by patients with hepatobiliary cancers (HCC). In this study, qualitative interviews were conducted to assess the content validity of the FHSI-8 among HCC patients with severe disease, as indicated by elevated alpha-fetoprotein (AFP). Utilizing a semi-structured interview guide, mixed concept elicitation and cognitive debriefing interviews were conducted via telephone with 7 adults with HCC and physician-confirmed elevated AFP (> 400 ng/mL). Recruitment was challenging due to the severity and poor prognosis of HCC, therefore multiple recruitment methods (clinical sites, advocacy groups and qualitative research firms) were employed. Field notes and interview transcriptions were used for thematic data analysis. All 7 participants reported pain, fatigue, lack of energy, and weight loss; 6 reported nausea, and 5 reported back pain, jaundice, and appetite loss. In addition, fatigue (n = 6), abdominal pain (n=5), back pain (n=3) and weight loss (n=3) were most frequently reported among the three most important symptoms to treat. Participants indicated that all items were relevant and important to retain, and no participant spontaneously identified any omitted symptoms. Participants easily answered and consistently interpreted all FHSI-8 items as intended, noted that the 7-day recall period was appropriate, and indicated that the response options were distinct. Most participants (n ≥ 5 per item) noted that a 1-point shift constituted a meaningful improvement. The results of this study are consistent with those of a targeted literature review of 32 publications, and confirm the content validity of the FHSI-8 in HCC patients with elevated AFP. Most importantly, the FHSI-8 assesses the symptoms study participants reported most frequently and identified as important to treat, supporting the use of the FSHI-8 in HCC clinical trials.

Is substance use associated with HIV cascade outcomes in Latin America?

BackgroundThe HIV care cascade has improved in Latin America over the last decade. However, the influence of alcohol and noninjected drug use (NIDU) on cascade outcomes is mostly unknown. This study estimated the association of alcohol and NIDU with retention in care, loss to follow up (LTFU), and virologic failure (VF).MethodsIndividuals ≥18 years attending routine HIV clinic visits and completing the Rapid Screening Tool (RST; evaluating NIDU and ART adherence in 7-day recall period) during 2012–13 were followed up to 2015 in the Caribbean, Central and South America network for HIV epidemiology. Adjusted odds ratios (aOR) were calculated for the association of alcohol consumption and NIDU with retention in care by logistic regression; adjusted hazard ratios (aHR) were estimated for the associations with LTFU and VF by Cox regression.ResultsAmong 3604 individuals, the proportions retained in care for one year were 84%, 79%, 72%, and 69% for patients reporting non-use, alcohol use, NIDU, and both alcohol and NIDU, respectively. For the same patient groups, the proportions LTFU over 18 months were 6%, 8%, 12%, and 13%, respectively. There were 1901 patients (53%) with HIV RNA results; VF proportions were similar between users and nonusers (ranging from 14–16%). After controlling for age, sex, study site, HIV transmission mode, time on ART, AIDS status, and CD4 count, neither alcohol use (aOR = 1.1, CI = 0.9–1.4; aHR = 1.0, CI = 0.8–1.3) nor NIDU (aOR = 1.3, CI = 0.9–1.8; aHR = 1.4, CI = 0.9–2.1) were significantly associated with retention or VF, respectively. However, both alcohol use (aHR = 1.2, CI = 1.02–1.4) and NIDU (aHR = 1.3, CI = 1.00–1.8) were associated with increased LTFU.ConclusionAlcohol use and NIDU in a 7-day recall period increased the risk of being LTFU during the next 18 months, highlighting the need for routine screening and targeted interventions to keep these individuals in care and on ART.