A systematic review of self-report measures used in epidemiological studies to assess alcohol consumption among older adults

Background There is a lack of standardization regarding how to assess and categorize alcohol intake in older adults. The aim of this study was to systematically review methods used in epidemiological studies to define drinking patterns and measure alcohol consumption among older adults. Methods A systematic search was conducted in the MEDLINE, PubMed, PsycINFO, EMBASE, and CINAHL databases for studies published from January 2009 to April 2021. Studies were included if they were observational studies with a quantitative design; the mean age of the participants was ≥ 65 years; questionnaires, screening tools, or diagnostic tools were used to define alcohol consumption; and alcohol consumption was self-reported. Results Of 492 studies considered, 105 were included. Among the 105 studies, we detected 19 different drinking patterns, and each drinking pattern had a wide range of definitions. The drinking patterns abstaining from alcohol, current drinking, and risk drinking had seven, 12 and 21 diverse definitions, respectively. The most used questionnaire and screening tools were the quantity-frequency questionnaire, with a recall period of 12 months, and the full and short versions of the Alcohol Use Disorders Identification Test, respectively. Conclusion No consensus was found regarding methods used to assess, define, and measure alcohol consumption in older adults. Identical assessments and definitions must be developed to make valid comparisons of alcohol consumption in older adults. We recommend that alcohol surveys for older adults define the following drinking patterns: lifetime abstainers, former drinkers, current drinkers, risk drinking, and heavy episodic drinking. Standardized and valid definitions of risk drinking, and heavy episodic drinking should be developed. The expanded quantity-frequency questionnaire including three questions focused on drinking frequency, drinking volume, and heavy episodic drinking, with a recall period of 12 months, could be used.

Challenges in Using Recommended Quality of Life Measures to Assess Fluctuating Health: A Think-Aloud Study to Understand How Recall and Timing of Assessment Influence Patient Responses

Background It can be challenging to measure quality of life to calculate quality-adjusted life-years in recurrent fluctuating health states, as quality of life can constantly change. It is not clear how patients who experience fluctuations complete measures and how assessment timing and recall influence responses. Objective We aimed to understand how patients with fluctuating health complete widely recommended and commonly used measures (EQ-5D-5L, EORTC QLQ-C30 and SF-12) and the extent to which the recall period (‘health today’, ‘past week’ and ‘past 4 weeks’) and timing of assessment influence the way that patients complete these questionnaires. Methods Twenty-four adult patients undergoing chemotherapy for urological, gynaecological or bowel cancers in the UK participated in think-aloud interviews, while completing the measures, completed a pictorial task illustrating how quality of life changed during the chemotherapy cycle and took part in semi-structured interviews. Transcripts were analysed using constant comparison. Results Patients were consistent in describing their quality of life as changing considerably throughout a chemotherapy cycle. The shorter recall period of ‘health today’ does not adequately represent patients’ quality of life because of fluctuations, patients remarked they could give a different answer depending on the timing of assessment, and many struggled to combine the “ups and downs” to answer measures with longer recall (‘past week’ and ‘past 4 weeks’). Across all measures, patients attempted to provide averages, adopt the peak-end rule or focus on the best part of their experience. Patients commonly used more than one approach when completing a given questionnaire as well as across questionnaires. Conclusions Patients who experience recurrent fluctuations in health are unable to provide meaningful responses about their quality of life when completing quality-of-life measures due to the recall period and timing of assessment. The use of such responses to calculate health state values in economic evaluations to inform resource allocation decisions in fluctuating conditions must be questioned.

Development, psychometric evaluation and cognitive debriefing of the rheumatoid arthritis symptom and impact questionnaire (RASIQ)

Background Rheumatoid arthritis (RA) is a chronic inflammatory disease often associated with persistent pain. There is a need for a patient-reported outcome measure (PROM) that is rooted in the patient experience and psychometrically validated. We describe the development of the Rheumatoid Arthritis Symptom and Impact Questionnaire (RASIQ), a novel PROM with potential to record key symptoms and impacts of RA with a 24-h recall period. Results A literature review identified RA concepts that patients considered most important to their disease experience, including pain, fatigue, joint swelling and stiffness. From this, an initial item pool (33 items; 27 related to symptoms, 6 related to impacts) was developed with a recall period of 24 h. Two rheumatologists evaluated each item’s relevance, and the second version of the RASIQ was refined (29 items; 21 related to symptoms, 8 related to impacts). Next, three rounds of cognitive debriefing interviews were conducted with patients with RA (n = 15 overall). The RASIQ was revised to remove items deemed irrelevant or redundant, leaving 16 items measuring symptoms (joint pain, energy/tiredness, joint stiffness) and impacts (rest, sleep). A parallel series of semi-structured concept elicitation interviews (n = 30) facilitated the design of a conceptual model of RA symptoms, impacts and treatment experiences. Post-hoc comparison of the model with RASIQ revealed that all items selected were among the most important and relevant symptoms and impacts for patients. A final round of cognitive debriefing interviews (n = 12) confirmed that the final 16-item RASIQ was relevant and easy to understand, with no further changes recommended. Psychometric evaluation using data from two Phase II RA clinical trials confirmed a 3-factor structure, as well as the reliability and validity of the scale scores, and the ability of RASIQ to detect changes in symptoms and impacts when administered at specific study timepoints, using a 24-h recall period. Conclusions RASIQ is a novel, 16-item PROM developed with substantial patient input. Results from concept elicitation, cognitive debriefing, and psychometric evaluation confirmed the validity of the instrument, which has the potential to measure symptoms and impacts through a 24-h recall period and complement existing disease activity instruments with longer recall periods.

One-week recall period gives a more accurate estimate of exclusive breastfeeding practice than 24-h recall among infants younger than six months of age

Background The World Health Organization recommends a 24-h recall period to estimate breastfeeding practice of mothers of infants aged younger than six-months. Though 24-h recall was preferred for its low recall bias and for practical reasons, it can overestimate exclusive breastfeeding practice (EBF). Validating this indicator will help account for the deviation from the true estimate. This prospective cohort study measured accuracy of the 24-h recall method and validates a week recall as an alternative approach for use in a small sample population. Method The study was conducted from March to April 2018 involving 408 mother-infant pairs living in Butajira Health and Demographic Surveillance Site (HDSS), Southern Ethiopia. Participants were prospectively followed for 14 consecutive days; where their breastfeeding practice in the past 24 h was measured daily. Exclusive breastfeeding prevalence estimate obtained using the 24-h recall method and recall periods spanning a varying number of days (short period recalls) was compared against the cumulative of the responses from a prospectively measured repeated 24-h recalls over the course of 14 days. McNemar statistics was used to assess statistical significance of the difference in the EBF prevalence estimates of the single 24-h recall and the reference standard. Sensitivity, specificity, positive predictive value and negative predictive values were calculated to determine the level of accuracy. Receiver Operating Characteristics curve was used to measure the difference in performance between the two methods. Result The highest prevalence (71.4%) of exclusive breastfeeding practice was estimated using the single 24-h recall method whereas the lowest breastfeeding practice (47.1%) was obtained from a cumulative of 14 repeated 24-h recalls. A week recall (a recall over 7 days’ period), resulted in the smallest discrepancy in estimate (7.1%) as compared to cumulative estimate of 14 repeated 24-h recalls. Comparing against our reference standard, a week recall had 96.7% sensitivity and 83.5% specificity in estimating exclusive breastfeeding practice. Conclusions Using single 24-h recall method overestimated exclusive breastfeeding prevalence. However, a week recall gave an estimate close to the estimate from the standard method. A week recall has a potential to balance the tradeoff between the accuracy of EBF estimates and the resource implication of using multiple prospective measurements that have a proven superior accuracy.

Long-term solid fuel use and risks of major eye diseases in China: A population-based cohort study of 486,532 adults

Background Over 3.5 billion individuals worldwide are exposed to household air pollution from solid fuel use. There is limited evidence from cohort studies on associations of solid fuel use with risks of major eye diseases, which cause substantial disease and economic burden globally. Methods and findings The China Kadoorie Biobank recruited 512,715 adults aged 30 to 79 years from 10 areas across China during 2004 to 2008. Cooking frequency and primary fuel types in the 3 most recent residences were assessed by a questionnaire. During median (IQR) 10.1 (9.2 to 11.1) years of follow-up, electronic linkages to national health insurance databases identified 4,877 incident conjunctiva disorders, 13,408 cataracts, 1,583 disorders of sclera, cornea, iris, and ciliary body (DSCIC), and 1,534 cases of glaucoma. Logistic regression yielded odds ratios (ORs) for each disease associated with long-term use of solid fuels (i.e., coal or wood) compared to clean fuels (i.e., gas or electricity) for cooking, with adjustment for age at baseline, birth cohort, sex, study area, education, occupation, alcohol intake, smoking, environmental tobacco smoke, cookstove ventilation, heating fuel exposure, body mass index, prevalent diabetes, self-reported general health, and length of recall period. After excluding participants with missing or unreliable exposure data, 486,532 participants (mean baseline age 52.0 [SD 10.7] years; 59.1% women) were analysed. Overall, 71% of participants cooked regularly throughout the recall period, of whom 48% used solid fuels consistently. Compared with clean fuel users, solid fuel users had adjusted ORs of 1.32 (1.07 to 1.37, p < 0.001) for conjunctiva disorders, 1.17 (1.08 to 1.26, p < 0.001) for cataracts, 1.35 (1.10 to 1.66, p = 0.0046) for DSCIC, and 0.95 (0.76 to 1.18, p = 0.62) for glaucoma. Switching from solid to clean fuels was associated with smaller elevated risks (over long-term clean fuel users) than nonswitching, with adjusted ORs of 1.21 (1.07 to 1.37, p < 0.001), 1.05 (0.98 to 1.12, p = 0.17), and 1.21 (0.97 to 1.50, p = 0.088) for conjunctiva disorders, cataracts, and DSCIC, respectively. The adjusted ORs for the eye diseases were broadly similar in solid fuel users regardless of ventilation status. The main limitations of this study include the lack of baseline eye disease assessment, the use of self-reported cooking frequency and fuel types for exposure assessment, the risk of bias from delayed diagnosis (particularly for cataracts), and potential residual confounding from unmeasured factors (e.g., sunlight exposure). Conclusions Among Chinese adults, long-term solid fuel use for cooking was associated with higher risks of not only conjunctiva disorders but also cataracts and other more severe eye diseases. Switching to clean fuels appeared to mitigate the risks, underscoring the global health importance of promoting universal access to clean fuels.

Self-paced part-list cuing

Ironically, the presentation of a subset of studied material as retrieval cues at test often impairs recall of the remaining (target) material—an effect known as part-list cuing impairment. Part-list cues are typically provided at the beginning of the recall period, a time when nearly all individuals would be able to recall at least some studied items on their own. Across two experiments, we examined the effects of part-list cuing when student participants could decide on their own when the cues were presented during the recall period. Results showed that participants activated the cues relatively late in the recall period, when recall was already close to asymptote. Critically, such delayed cuing no longer impaired recall performance. The detrimental effect of part-list cuing, as it has been demonstrated numerous times in the memory literature, thus seems to depend on presentating the cue items (too) early in the recall period.

Development and Content Validation of the Symptoms Evolution of COVID-19: A Patient-Reported Electronic Daily Diary in Clinical and Real-World Studies

Importance: At the onset of the COVID-19 pandemic, there was limited understanding of symptom experience and disease progression. Objective: We developed and validated a fit-for-purpose, disease-specific instrument to assess symptoms in patients with COVID-19 to inform endpoints in an interventional trial for non-hospitalized patients. Design: The initial drafting of the 23-item Symptoms Evolution of COVID-19 (SE-C19) Instrument was developed based on the Centers for Disease Control and Prevention symptom list and available published literature specific to patients with COVID-19 as of Spring 2020. The measurement principles in the Food and Drug Administration patient-reported outcomes guidance and the four methodological Patient-Focused Drug Development Guidances were also considered. Setting: Interviews were conducted virtually with patients recruited through a healthcare research firm. Participants: Semi-structured qualitative interviews were conducted with a purposive sample of 30 non-hospitalized patients with COVID-19 Intervention: Interviews involved two stages: (1) concept elicitation, to obtain information about the symptoms experienced as a result of COVID-19 in patients' own words, and (2) cognitive debriefing, for patients to describe their understanding of the SE-C19 instructions, specific symptoms, response options, and recall period to ensure the content of the SE-C19 is relevant and comprehensive. Five clinicians treating COVID-19 outpatients were interviewed to obtain their insights on symptoms experienced by patients and provide input on the SE-C19. Main Outcome and Measure: Patients reported no issues regarding the relevance or appropriateness of the SE-C19 instructions, including the recall period. The comprehensiveness of the SE-C19 was confirmed against the conceptual model developed in the qualitative research. Minor conceptual gaps were revealed to capture nuances in the experience of nasal and gustatory symptoms, and systemic manifestations of sickness. Almost all items were endorsed by patients as being appropriate and well understood. The clinicians largely approved all items, response options, and recall period. Conclusions and Relevance: The qualitative research provided supportive evidence of the content validity of the SE-C19 instrument to assess the symptoms of outpatients with COVID-19 and its use in clinical trials to evaluate the benefit of treatment. Minor changes may be considered to improve conceptual clarity and ease of responding. Trial Registration: R10933-10987-COV-2067 (https://clinicaltrials.gov/ct2/show/NCT04425629)

P485 Development and implementation of a remote monitoring tool for real-world assessment of mild, moderate and severe infectious complications in Inflammatory Bowel Disease patients

Background Immunomodulators and biologicals are cornerstones in the current management of Inflammatory Bowel Disease (IBD), but are associated with increased risk of infections. Post-marketing surveillance studies are important to assess the risk for infectious side effects in real-world populations, yet mainly focus on severe infections. Data on mild and moderate infections in IBD patients are scarce, primarily since self-limiting infections and infections treated by the general practitioner are not systematically captured in surveillance registries. Mild and moderate infections take longer to clear in immunosuppressed patients, have a large impact on (work) disability and quality of life, and potentially precede severe infections. In the current study, we aimed to develop and implement a remote monitoring tool for real-world assessment of infections in IBD patients. Methods Through a structured iterative process with input from IBD specialists, nurse practitioners, and a comprehensive literature review, a 7-item Questionnaire comprising 15 different types of infections (covering e.g. upper/lower respiratory tract; urinary tract; eye; and skin infections) was developed to measure Patient-Reported Infections (PRIQ) with a recall period of 3 months. Infection severity was defined as either mild (self-limiting or requiring topical/local treatment), moderate (requiring oral antibiotic, antiviral or antifungal drugs) or severe (requiring hospitalization and/or IV treatment). To ascertain comprehensiveness and comprehensibility in the intended study population prior to implementation, in three rounds a total of 36 randomly selected IBD patients visiting the outpatient clinic were interviewed individually until saturation was reached. Results Overall, patient understanding of the PRIQ was good and cognitive interviews did not result in reduction of questionnaire-items. Analysis of feedback from interviews resulted in addition of definitions to certain response options (e.g. definition for antivirals) and minor linguistic adjustments to further improve patient understanding. A total of three patients (8.3%) raised concerns on the recall period of 3 months, which after expert consensus, did not result in alteration of the recall period. Next, the PRIQ was digitized and implemented in myIBDcoach, an established telemedicine platform for management of IBD. Conclusion We developed a remote monitoring tool (PRIQ) to assess patient-reported infections in IBD and ascertained patient understanding through cognitive interviewing. A prospective multicentre study using the myIBDcoach platform is ongoing to validate the PRIQ and subsequently report the risk of mild and moderate infections across different treatment regimens in IBD patients (NCT04151420).

Enhancing validity, reliability and participation in self-reported health outcome measurement for children and young people: a systematic review of recall period, response scale format, and administration modality

Introduction Self-report is the gold standard for measuring children’s health-related outcomes. Design of such measures is complex and challenging. This review aims to systematically appraise the evidence on recall period, response scale format, mode of administration and approaches needed to enable children and young people < 19 years to participate in valid and reliable self-reporting of their health outcomes. Method PsycInfo, Medline, CINAHL and Embase were searched from 1 January 1990 to 15 March 2020, and citation searching undertaken in Scopus. Articles were included if they were primary research or case reports of ≥ 3 participants reporting the following: recall period, response scale selection, administration modality. Quality was assessed using QualSyst, and results synthesised narratively. This review was conducted and reported according to PRISMA guidelines. Results 81 of 13,215 retrieved articles met the inclusion criteria. Children < 5 years old cannot validly and reliably self-report health outcomes. Face scales demonstrate better psychometric properties than visual analogue or Likert scales. Computerised and paper scales generally show equivalent construct validity. Children prefer computerised measures. Children ≤ 7 years old think dichotomously so need two response options. Those > 8 years old can reliably use a 3-point scale. Conclusion The results of this review have both clinical and research implications. They can be used to inform appropriate choice of PROM for use with CYP in the clinical setting. We also give eight recommendations for future development of self-reported outcome measures for children and young people.