Recall Period Research Articles

Comparing estimates of psychological distress using 7-day and 30-day recall periods: Does it make a difference?

Self-report measures are widely used in mental health research and may use different recall periods depending on the purpose of the assessment. A range of studies aiming to monitor changes in mental health over the course of the COVID-19 pandemic opted to shorten recall periods to increase sensitivity to change over time compared to standard, longer recall periods. However, many of these studies lack pre-pandemic data using the same recall period and may rely on pre-existing data using standard recall periods as a reference point for assessing the impact of the pandemic on mental health. The aim of this study was to assess whether comparing scores on the same questionnaire with a different recall period is valid. A nationally representative sample of 327 participants in Australia completed a 7-day and 30-day version of the six-item Kessler Psychological Distress Scale (K6) and a single-item measure of psychological distress (TTPN item) developed for the Taking the Pulse of the Nation survey. Linear mixed models and mixed logistic regression models were used to assess whether altering the recall period systematically changed response patterns within subjects. No substantive recall period effects were found for the K6 or the TTPN, although there was a trend towards higher K6 scores when asked about the past 30 days compared to the past 7 days (b = 1.00, 95% CI: -0.18, 2.17). This may have been driven by the “feeling nervous” item which was rated higher using the 30-day compared to the 7-day recall period. Neither the K6 nor the TTPN item were significantly affected by the recall period when reduced to a binary variable of likely severe mental illness. The results indicate that altering the recall period of psychological distress measures does not substantively alter the score distribution in the general population of Australian adults.

Assessing the content validity of the Manchester–Oxford Foot Questionnaire in surgically treated ankle fracture patients: a qualitative study

BackgroundRoughly 10% of fractures in adults are ankle fractures. These injuries are found in both sexes and present with different fracture characteristics. The treatment varies with the patients’ biology and fracture type, and the goals are to restore stability, prevent pain and maintain ankle function. Clinicians generally use outcomes like assessment of radiography, pain level, or function. The use of patient-reported outcome measures is increasing, and the Manchester–Oxford Foot Questionnaire (MOXFQ) has been shown to have good measurement properties when validated in patients with foot and ankle disorders. However, the instrument has not been validated for ankle fracture patients. This study aims to assess the content validity of the items in MOXFQ in surgically treated ankle fracture patients.MethodsA qualitative deductive design was used to investigate patients’ response process of the MOXFQ. Individual interviews were conducted using cognitive interviewing based on the theoretical framework of the 4-step model by Tourangeau. Adult patients that were surgically treated for an ankle fracture between four weeks and 18 months were purposively sampled, and interviews followed a semi-structured interview guide. The predetermined categories were comprehension, retrieval, judgement, and response.ResultsSeventeen respondents (65% females) were interviewed. Respondents’ age ranged from 27 to 76 years. Some of the respondents in the early recovery phase were limited by post-operative restrictions and did not find the items in the walking/standing domain relevant. Respondents that were allowed weight-bearing as tolerated (WBAT) were able to recall relevant information for most items. Respondents with time since surgery more than 12 months had less pain and remembered fewer relevant episodes in the recall period. Items in the social interaction domain contained ambiguous questions and were generally considered less important by respondents. The summary index score lacked important concepts in measuring overall quality of life.ConclusionsPain was a central concept in the post-operative recovery of ankle fracture patients. The MOXFQ-subscales for pain and walking/standing had acceptable content validity in patients that were allowed WBAT. The social interaction-subscale and the summary index score had insufficient content validity for this patient population.

Impact of the withdrawal of macrotextured implant on reconstruction practices

On 22 November 2018, the French Society for Plastic, Reconstructive and Aesthetic Surgery recommended that Allergan® macrotextured breast implants be recalled, a decision endorsed by the French national health products safety agency (ANSM) on 2nd April 2019. At the Georges-François Leclerc Cancer Center (CGFL) in Dijon, we decided to stop using macrotextured implants as of November 2018 in favor of smooth implants. The purpose of this study is to evaluate the impact of the recall of macrotextured implants on breast reconstruction surgical practices and their complications. This is a single-centre, retrospective study performed at the CGFL in Dijon, France. Reconstruction techniques and complications were compared between two periods, i.e. before the recall of macrotextured breast implants (period 1: 1st September 2017-November 22, 2018) and after the recall (period 2: 23 November 2018-31st March 2020). All patients who underwent breast reconstruction for the first time were included. Data were collected from 168 reconstructions in period 2, and 159 in period 2. The rate of use of breast implants during reconstructions decreased significantly in period 2 (53.6% vs. 23.9%; P<0.001). The rate of autologous reconstructions increased significantly for muscle sparing latissimus dorsi (2.4% vs. 12.6%; P<0.001) and exclusive fat grafting (9.5% vs. 21.5%; P<0.01). Clavien-Dindo Stage IIIb complications decreased in period 2 (10% vs. 18.4%; P=0.04). Since the recall of macrotextured breast implants, the reconstruction rate has decreased in our centre in favor of autologous techniques with lower complication rates.

Myopia progression patterns among paediatric patients in a clinical setting.

This retrospective analysis of electronic medical record (EMR) data investigated the natural history of myopic progression in children from optometric practices in Ireland. The analysis was of myopic patients aged 7-17 with multiple visits and not prescribed myopia control treatment. Sex- and age-specific population centiles for annual myopic progression were derived by fitting a weighted cubic spline to empirical quantiles. These were compared to progression rates derived from control group data obtained from 17 randomised clinical trials (RCTs) for myopia. Linear mixed models (LMMs) were used to allow comparison of myopia progression rates against outputs from a predictive online calculator. Survival analysis was performed to determine the intervals at which a significant level of myopic progression was predicted to occur. Myopia progression was highest in children aged 7 years (median: -0.67 D/year) and progressively slowed with increasing age (median: -0.18 D/year at age 17). Female sex (p < 0.001), a more myopic SER at baseline (p < 0.001) and younger age (p < 0.001) were all found to be predictive of faster myopic progression. Every RCT exhibited a mean progression higher than the median centile observed in the EMR data, while clinic-based studies more closely matched the median progression rates. The LMM predicted faster myopia progression for patients with higher baseline myopia levels, in keeping with previous studies, which was in contrast to an online calculator that predicted slower myopia progression for patients with higher baseline myopia. Survival analysis indicated that at a recall period of 12 months, myopia will have progressed in between 10% and 70% of children, depending upon age. This study produced progression centiles of untreated myopic children, helping to define the natural history of untreated myopia. This will enable clinicians to better predict both refractive outcomes without treatment and monitor treatment efficacy, particularly in the absence of axial length data.

Evaluating the agreement between different substance use recall periods in multiple HIV cohorts

BackgroundThis study aims to evaluate the agreement in substance use on both binary and ordinal scales between 3-month and 6-month recall periods with samples from different communities, demographic backgrounds, and HIV status. MethodsWe administered the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) to 799 participants from three different North American cohorts focused on substance use and HIV. We conducted a within-person agreement analysis by calculating the agreement levels and Kappa statistic between data collected using the 3-month recall ASSIST and 6-month custom substance use surveys as well as different terminology for each substance in multiple cohorts. ResultsFor all drugs studied, the agreement on the binary use or ordinal frequency of use metrics showed a high agreement level between 80.4% and 97.9% and an adequate adjusted kappa value between 0.61 and 0.96, suggesting substantial agreement. According to the agreement criteria we proposed, substance use data collected using different recall periods and with variation in drug names can be harmonized across cohorts. ConclusionsThis study is the first to evaluate the feasibility of data harmonization of substance use by demonstrating high level of agreement between different recall periods in different cohorts. The results can inform data harmonization efforts in consortia where data are collected from cohorts using different questions and recall periods.

A Snapshot Audit of Symptom Burden in Patients with Indolent Systemic Mastocytosis Utilising the ISM-SAF © within a UK Centre of Excellence: Guy's and St Thomas' NHS Foundation Trust

Background: Indolent systemic mastocytosis (ISM) is a rare, clonal haematological neoplasm driven by the KIT D816V mutation in up to 95% of cases. It is characterized by a debilitating, heterogenous and unpredictable symptom burden due to mast cell mediator release among patients. Treatment is limited to symptom management with no approved targeted therapies in the UK. The Indolent Systemic Mastocytosis Symptom Assessment Form (ISM-SAF ©) (Taylor et al. [2021]) is a validated symptom-assessment tool developed specifically for ISM patients focusing on 11 symptoms over a 24-hour recall period: bone pain, abdominal pain, nausea, skin spots, itch, flushing, fatigue, dizziness, brain fog, headache and diarrhoea. Each symptom is scored on a scale from 0-10. To date, there has not been any published UK data examining symptom burden in ISM patients. Subsequently we assessed symptom burden utilising the ISM-SAF © in our patient cohort at Guy's and St Thomas' Hospital. Method: All adult ISM patients who had a routine outpatient appointment between May 2022 and May 2023 were identified retrospectively. Over a four-week period, patients were invited to complete the ISM-SAF © by telephone or in person. Additionally we collected demographic data, clinical data, anti-mediator therapy, anaphylaxis history and the impact of SM on their work and quality of life. All consultations were conducted by a clinical member of the mastocytosis team. Results: 95 adult patients with ISM were identified within our database, of which 76 consented to take part in this study. There was a slight female predominance (41% male; 59% female) and the median age at diagnosis was 46 years (range 21 - 78). Median time to ISM diagnosis was 4.6 years (range 0.5-18.5). Median serum tryptase was 35 mcg/L (range 9-632). 66 patients (88%) were noted to have the KIT D816V mutation (6% D816V-negative, 6% not available). The median Total Symptom Score (TSS) was 24 (range 0-110). The highest scoring symptoms were fatigue (mean score 4.66), skin spots (3.97), brain fog (3.43) and itch (2.83). 33 patients (43%) had a TSS ≥28 which is the threshold determined by psychometric analysis to identify patients with moderate to severe symptoms, and is used for screening in clinical trials (Shields et al. [2023]). 46 patients (61%) were prescribed ≥2 anti-mediator therapies; at the time of the study, current therapies included H1 antihistamines (n=64), H2 antihistamines (n=28), proton pump inhibitors (n=20), sodium cromoglycate (n=18), montelukast (n=12), corticosteroid (n=5) and omalizumab (n=1). 12 patients (16%) were on a bisphosphonate. The number of patients with both a TSS ≥28 and on ≥2 anti-mediator therapies was 27 (36%). 30 patients (39%) reported a history of anaphylaxis at least once in their lifetime while 12% (n=9) reported using an adrenaline autoinjector within the last 12 months. There was no statistically significant correlation between TSS and serum tryptase (Pearson correlation coefficient r= -0.08, p=0.48). Some patients reported having to reduce their working hours, needing adjustments or retiring early due to symptoms attributed to their ISM diagnosis. Conclusions: Our data demonstrate a significant real-world symptom burden among the ISM patient cohort within the UK Mastocytosis Centre of Excellence and reflect the findings of other centres, in particular fatigue being the most severe symptom (van Anrooij et al. [2016]; Mesa et al. [2022]). The ISM-SAF © is an effective tool for capturing a snapshot of symptom severity and has utility in the outpatient setting. Importantly, we found over one third of patients in our centre had a TSS ≥28 and were on ≥2 anti-mediator therapies, meaning they could potentially be eligible to access tyrosine kinase inhibitors within the clinical trial setting.

Qualitative and psychometric evaluation of the PROMIS®-Fatigue SF-7a scale to assess fatigue in patients with moderately to severely active inflammatory bowel disease

BackgroundThis study evaluated the content validity and psychometric properties of the Patient-Reported Outcomes Measurement Information System® (PROMIS)-Fatigue Short Form 7a (SF-7a) v1.0 scale to determine its suitability in clinical trials to assess fatigue in patients with moderately to severely active Crohn’s disease (CD) and ulcerative colitis (UC).MethodsA qualitative interview assessed patients’ experience living with CD (N = 20) and UC (N = 19). The contents of the SF-7a scale were cognitively debriefed to evaluate content validity. A psychometric evaluation was performed using data from clinical trials of patients with CD (N = 360) and UC (N = 214). Correlations with Inflammatory Bowel Disease Questionnaire (IBDQ), Crohn’s Disease Activity Index (CDAI; CD only), and Mayo score (UC only) determined validity. The Patient Global Impression of Change (PGIC) was used to evaluate reliability and responsiveness to change. Using PGIC as an anchor, a preliminary threshold for clinically meaningful change was identified to define fatigue response in both CD and UC patients.ResultsAll patients reported fatigue as a common symptom. Patients confirmed SF-7a items were relevant to assessing fatigue, instructions and response options were clear, and its 7-day recall period was appropriate. Higher SF-7a scores were associated with higher disease activity (CDAI and Mayo score) and lower health-related quality of life (IBDQ), confirming known groups validity. The correlation of the SF-7a scale was higher with fatigue-related items. (rs ≥ -0.70) than with items not directly associated with fatigue. Test-retest reliability was moderate to good (0.54–0.89) among patients with stable disease, and responsiveness to change in disease severity was demonstrated from baseline to Week 12. A ≥7point decrease was identified as a reasonable threshold to define clinically meaningful improvement.ConclusionThe SF-7a scale is a valid, reliable, and sensitive measure of fatigue in patients with moderately to severely active IBD and can be used to evaluate treatment response.

Agreement between self-reports and statutory health insurance claims data on healthcare utilization in patients with mental disorders

BackgroundData on resource use are frequently required for healthcare assessments. Studies on healthcare utilization (HCU) in individuals with mental disorders have analyzed both self-reports and administrative data. Source of data may affect the quality of analysis and compromise the accuracy of results. We sought to ascertain the degree of agreement between self-reports and statutory health insurance (SHI) fund claims data from patients with mental disorders.MethodsClaims data from six German SHI and self-reports were obtained along with a cost-effectiveness analysis performed as a part of a controlled prospective multicenter cohort study conducted in 18 psychiatric hospitals in Germany (PsychCare), including patients with pre-defined psychiatric disorders. Self-reports were collected using the German adaption of the Client Sociodemographic and Service Receipt Inventory (CSSRI) questionnaire with a 6-month recall period. Data linkage was performed using a unique pseudonymized identifier. Missing responses were coded as non-use for all analyses. HCU was calculated for inpatient and outpatient care, day-care services, home treatment, and pharmaceuticals. Concordance was measured using Cohen’s Kappa (κ) and intraclass correlation coefficient (ICC). Regression approaches were used to investigate the effect of independent variables on the agreements.ResultsIn total 274 participants (mean age 47.8 [SD = 14.2] years; 47.08% women) were included in the analysis. No significant differences were observed between the linked and unlinked patients in terms of baseline characteristics. Total agreements values were 63.9% (κ = 0.03; PABAK = 0.28) for outpatient contacts, 69.3% (κ = 0.25; PABAK = 0.39) for medication use, 81.0% (κ = 0.56; PABAK = 0.62) for inpatient days and 86.1% (κ = 0.67; PABAK = 0.72) for day-care services. There was varied quantitative agreement between data sources, with the poorest agreement for outpatient care (ICC [95% CI] = 0.22 [0.10–0.33]) and the best for psychiatric day-care services (ICC [95% CI] = 0.72 [0.66–0.78]). Marital status and time since first treatment positively affected the chance of agreement on utilization of outpatient services.ConclusionsAlthough there were high levels of absolute agreement, the measures of concordance between administrative records and self-reports were generally minimal to moderate. Healthcare investigations should consider using linked or at least different data sources to estimate HCU for specific utilization areas, where unbiased information can be expected.Trial registrationThis study was part of the multi-center controlled PsychCare trial (German Clinical Trials Register No. DRKS00022535; Date of registration: 2020–10-02).

Dietary patterns in relation with nutritional outcomes and associated factors among adolescents: implications for context-specific dietary intervention for the Agrarian Community, Northwest Ethiopia.

Dietary pattern analysis allows us to characterize the dietary intakes of individuals rather than nutrient intake data and strongly predicts disease risks. The relationship between food intake and adolescents' nutritional health is not well understood yet. Therefore, this study aimed to generate evidence for context-specific dietary intervention for adolescents. This study aimed to determine dietary patterns and their relationship with nutritional outcomes and identify the contributing factors among adolescents in the Agrarian Community of Northwest Ethiopia. A cross-sectional survey was conducted among 622 randomly selected adolescents. Dietary data were collected over a 1-week recall period using the Food Frequency Questionnaire (FFQ). After testing the basic assumptions, an exploratory factor analysis was conducted to determine the dietary patterns. Anthropometric data on weight and height were collected to determine the nutritional status using WHO Anthroplus 2010 software. A chi-square test was conducted to evaluate the effect of different dietary patterns on nutritional outcomes. A multivariable binary logistic regression model was used to identify factors affecting the dietary patterns of adolescents. Three types of dietary patterns, namely, traditional, mixed, and animal-source foods with traditional alcoholic beverage consumption were identified. These dietary patterns explain 58.64% of the variance in adolescent diet in the study setting. The burden of stunting was 15.12% vs. 11.21, 19.40% vs. 6.94, and 8.36% vs.17.97% among adolescents with lower traditional, mixed, and higher animal sources with alcoholic dietary pattern consumption habits, respectively (value of p <0.05). Adolescents who resided in low-land agroecology (AOR = 2.44; 95% CL: 1.24, 4.81) and had access to animal-source foods (AOR = 1.64; 95% CI: 1.04, 2.60) were associated with lower consumption of traditional dietary patterns. Similarly, adolescents who resided in low-land (AOR = 1.80; 95% CI: 1.18, 2.74) had formal education (AOR = 2.38; 95% CI: 1.35, 4.19) and had poor nutrition knowledge (AOR = 2.83; 95% CL: 1.55, 5.19) were associated with lower consumption of mixed dietary patterns. Moreover, adolescents residing in the high-land (AOR = 2.50; 95% CI: 1.37, 4.56) and being female (AOR =1.87; 95% CI: 1.27, 2.74) were significant factors associated with lower consumption of animal-sourced foods with traditional alcoholic beverage consumption patterns. Multidimensional modifiable factors were explored that could be targeted for public health interventions for the identified dietary patterns. Integrated and multifaceted dietary intervention approaches are needed to promote healthy diets and discourage the consumption of unhealthy diets to reduce undernutrition in the study area and similar settings.

Commonalities and differences in set-up and data collection across European spondyloarthritis registries — results from the EuroSpA collaboration

BackgroundIn European axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA) clinical registries, we aimed to investigate commonalities and differences in (1) set-up, clinical data collection; (2) data availability and completeness; and (3) wording, recall period, and scale used for selected patient-reported outcome measures (PROMs).MethodsData was obtained as part of the EuroSpA Research Collaboration Network and consisted of (1) an online survey and follow-up interview, (2) upload of real-world data, and (3) selected PROMs included in the online survey.ResultsFifteen registries participated, contributing 33,948 patients (axSpA: 21,330 (63%), PsA: 12,618 (37%)). The reported coverage of eligible patients ranged from 0.5 to 100%. Information on age, sex, biological/targeted synthetic disease-modifying anti-rheumatic drug treatment, disease duration, and C-reactive protein was available in all registries with data completeness between 85% and 100%. All PROMs (Bath Ankylosing Spondylitis Disease Activity and Functional Indices, Health Assessment Questionnaire, and patient global, pain and fatigue assessments) were more complete after 2015 (68–86%) compared to prior (50–79%). Patient global, pain and fatigue assessments showed heterogeneity between registries in terms of wording, recall periods, and scale.ConclusionImportant heterogeneity in registry design and data collection across fifteen European axSpA and PsA registries was observed. Several core measures were widely available, and an increase in data completeness of PROMs in recent years was identified. This study might serve as a basis for examining how differences in data collection across registries may impact the results of collaborative research in the future.

Clinical indicators for diabetic eyecare delivered by optometrists in Australia: a Delphi study

ABSTRACT Clinical relevance Valid and updated clinical indicators can serve as important tools in assessing and improving eyecare delivery. Background Indicators for diabetic eyecare in Australia were previously developed from guidelines published before 2013 and then used to assess the appropriateness of care delivery through a nationwide patient record card audit (the iCareTrack study). To reflect emerging evidence and contemporary practice, this study aimed to update clinical indicators for optometric care for people with type 2 diabetes in Australia. Methods Forty-five candidate indicators, including existing iCareTrack and new indicators derived from nine high-quality evidence-based guidelines, were generated. A two-round modified Delphi process where expert panel members rated the impact, acceptability, and feasibility of the indicators on a 9-point scale and voted for inclusion or exclusion of the candidate indicators was used. Consensus on inclusion was reached when the median scores for impact, acceptability, and feasibility were ≥7 and >75% of experts voted for inclusion. Results Thirty-two clinical indicators with high acceptability, impact and feasibility ratings (all median scores: 9) were developed. The final indicators were related to history taking (n = 12), physical examination (n = 8), recall period (n = 5), referral (n = 5), and patient education/communication (n = 2). Most (14 of 15) iCareTrack indicators were retained either in the original format or with modifications. New indicators included documenting the type of diabetes, serum lipid level, pregnancy, systemic medications, nephropathy, Indigenous status, general practitioner details, pupil examination, intraocular pressure, optical coherence tomography, diabetic retinopathy grading, recall period for high-risk diabetic patients without retinopathy, referral of high-risk proliferative retinopathy, communication with the general practitioner, and patient education. Conclusion A set of 32 updated diabetic eyecare clinical indicators was developed based on contemporary evidence and expert consensus. These updated indicators inform the development of programs to assess and enhance the eyecare delivery for people with diabetes in Australia.

Development and Validation of a Canine Health-Related Quality of Life Questionnaire and a Human-Canine Bond Questionnaire for Use in Veterinary Practice.

The use of valid questionnaires to assess dogs' health-related quality of life (HRQoL) in veterinary practice can improve canine health outcomes and communications between veterinarians and caretakers of dogs. The Canine HRQoL Questionnaire (Canine HRQoL-Q) and the Human-Canine Bond Questionnaire (HCBQ) were developed and validated to fulfill this need. A literature review, interviews with veterinarians, and focus groups with caretakers were conducted to generate questionnaire items and develop draft questionnaires, which were piloted with caretakers to establish their content validity. Measurement properties were evaluated using data from a prospective survey study (N = 327). Draft Canine HRQoL-Q and HCBQ measures were developed, including a domain structure, items, recall period, and scale/response options. Refinements were made via iterative cognitive interviews with caretakers. When no additional revisions were indicated and content validity was established, the questionnaires were psychometrically tested. Ceiling effects were observed for all items, and factor analyses indicated that the pre-specified domains are appropriate. Internal consistency was demonstrated for the HCBQ (α = 0.79-0.86) and all but the social functioning domain of the Canine HRQoL-Q (α = 0.60). Test-retest reliability for the Canine HRQoL-Q was generally moderate-to-good (with intraclass correlation coefficients (ICCs) > 0.79). Test-retest reliability for the HCBQ was moderate (ICCs: 0.70-0.79) except for the trust domain (ICC: 0.58). Known-groups validity was demonstrated via significant differences (p < 0.05) in scores for health/bonding groups. Convergent validity was supported (r > 0.40) between all domains and the total scores for both questionnaires. The Canine HRQoL-Q and the HCBQ are valid, reliable measures of canine HRQoL for use in veterinary clinics and appear to measure related but distinct concepts that contribute to canine health and wellness.

Testing a Model of Care for Patients on Immune Checkpoint Inhibitors Based on Electronic Patient-Reported Outcomes: Protocol for a Randomized Phase II Controlled Trial.

Management of severe symptomatic immune-related adverse events (IrAEs) related to immune checkpoint inhibitors (ICIs) can be facilitated by timely detection. As patients face a heterogeneous set of symptoms outside the clinical setting, remotely monitoring and assessing symptoms by using patient-reported outcomes (PROs) may result in shorter delays between symptom onset and clinician detection. We assess the effect of a model of care for remote patient monitoring and symptom management based on PRO data on the time to detection of symptomatic IrAEs from symptom onset. The secondary objectives are to assess its effects on the time between symptomatic IrAE detection and intervention, IrAE grade (severity), health-related quality of life, self-efficacy, and overall survival at 6 months. For this study, 198 patients with cancer receiving systemic treatment comprising ICIs exclusively will be recruited from 2 Swiss university hospitals. Patients are randomized (1:1) to a digital model of care (intervention) or usual care (control group). Patients are enrolled for 6 months, and they use an electronic app to complete weekly Functional Assessment of Cancer Therapy-General questionnaire and PROMIS (PROs Measurement Information System) Self-Efficacy to Manage Symptoms questionnaires. The intervention patient group completes a standard set of 37 items in a weekly PROs version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) questionnaire, and active symptoms are reassessed daily for the first 3 months by using a modified 24-hour recall period. Patients can add items from the full PRO-CTCAE item library to their questionnaire. Nurses call patients in the event of new or worsening symptoms and manage them by using a standardized triage algorithm based on the United Kingdom Oncology Nursing Society 24-hour triage tool. This algorithm provides guidance on deciding if patients should receive in-person care, if monitoring should be increased, or if self-management education should be reinforced. The Institut Suisse de Recherche Expérimentale sur le Cancer Foundation and Kaiku Health Ltd funded this study. Active recruitment began since November 2021 and is projected to conclude in November 2023. Trial results are expected to be published in the first quarter of 2024 and will be disseminated through publications submitted at international scientific conferences. This trial is among the first trials to use PRO data to directly influence routine care of patients treated with ICIs and addresses some limitations in previous studies. This trial collects a wider spectrum of self-reported symptom data daily. There are some methodological limitations brought by changes in evolving treatment standards for patients with cancer. This trial's results could entail further academic discussions on the challenges of diagnosing and managing symptoms associated with treatment remotely by providing further insights into the burden symptoms represent to patients and highlight the complexity of care procedures involved in managing symptomatic IrAEs. ClinicalTrials.gov NCT05530187; https://www.clinicaltrials.gov/study/NCT05530187. DERR1-10.2196/48386.

Electronic Patient-Reported Outcomes in Hidradenitis Suppurativa: Content Validity and Usability of the Electronic Hidradenitis Suppurativa Symptom Daily Diary, Hidradenitis Suppurativa Symptom Questionnaire, and Hidradenitis Suppurativa Quality of Life Questionnaire

Background: Hidradenitis suppurativa (HS), a chronic skin condition that causes pain and physical dysfunction, can impact significantly on quality of life. Disease-specific tools have been designed to assess the impact of HS on patients, including the HS Symptom Daily Diary (HSSDD), the HS Symptom Questionnaire (HSSQ), and the HS Quality of Life (HiSQOL^©) questionnaire, which have been developed into electronic instruments (eHSSDD, eHSSQ, and eHiSQOL^©). Objectives: The objective of this study was to establish the content validity of the electronic version of the HSSDD and HSSQ, and the acceptability and usability of the HSSDD, HSSQ, and HiSQOL^©, using concept elicitation and cognitive debriefing interviews. Methods: This was a non-interventional qualitative video interview study involving participants aged ≥18 years with moderate to severe HS recruited from a single clinical site in the USA. Interviews gathered feedback on participants’ symptom experience, followed by training and completion of the eHSSDD, eHSSQ, and eHiSQOL^© questionnaires on electronic handheld devices. Participants were then interviewed on the content of the eHSSDD and eHSSQ and the acceptability and usability of all three instruments. Interviews were transcribed and qualitatively analysed. Results: Twenty participants with moderate to severe HS (median age: 41.5 [range: 20.0–64.0]; n = 16/20 female) were included. All participants found the eHSSDD, eHSSQ, and eHiSQOL^© instructions clear and described the instruments as “easy”, “simple” and “self-explanatory”. Overall understanding of individual items within the eHSSDD and eHSSQ was high; however, 6/20 participants had difficulty in understanding the average skin pain item in the eHSSDD. All participants were able to accurately recall their symptoms within the recall periods of the eHSSDD and eHSSQ, although 4/20 participants found the 24-h recall period of the eHSSDD limiting. Completion time was quick across all instruments, and usability was high, with the majority of participants reporting no difficulty in completing questionnaires on electronic devices. Conclusion: The concepts covered in the eHSSDD and eHSSQ are relevant and important to patients, supporting their content validity. The findings also provide evidence of acceptability and usability of the eHSSDD, eHSSQ, and eHiSQOL^©. A limitation was that all participants were recruited from a single site, which may have introduced selection bias and thus limited the generalisability of results.

Face Validity of Four Preference-Weighted Quality-of-Life Measures in Residential Aged Care: A Think-Aloud Study.

There is an increased use of preference-weighted quality-of-life measures in residential aged care to guide resource allocation decisions or for quality-of-care assessments. However, little is known about their face validity (i.e., how understandable, appropriate and relevant the measures are 'on their face' when respondents complete them). The aim of this study was to assess the face validity of four preference-weighted measures (i.e., EQ-5D-5L, EQ-HWB, ASCOT, QOL-ACC) in older people living in residential aged care. Qualitative cognitive think-aloud interviews were conducted using both concurrent and retrospective think-aloud techniques. To reduce burden, each resident completed two measures, with the four measures randomised across participants. Audio recordings were transcribed and framework analysis was used for data analysis, based on an existing framework derived from the Tourangeau four-stage response model. In total, 24 interviews were conducted with residents living across three residential aged care facilities in Melbourne, Australia. Response issues were identified across all four measures, often related to comprehension and difficulty selecting a response level due to double-barrelled and ambiguous items that have different meanings in the residential aged care context. We also identified issues related to understanding instructions, non-adherence to the recall period, and noted positive responding that requires attention when interpreting the data. Our findings provide further evidence on the appropriateness of existing measures, indicating numerous response issues that require further research to guide the selection process for research and practice.

Patient perspectives on recall period and response options in patient-reported outcome measures for chronic rhinosinusitis symptomatology: An international multi-centered study.

Existing patient-reported outcome measures (PROMs) for chronic rhinosinusitis (CRS) use a variety of recall periods and response scales to assess CRS symptom burden. Global perspectives of CRS patients regarding optimal recall periods and response scales for CRS PROMs are unknown. This was a multi-center, cross-sectional study recruiting 461 CRS patients from sites across the United States, Saudi Arabia, New Zealand, and Austria. Participants chose which CRS symptom recall period (1 day, 2weeks, 1 month,>1 month) was most reflective of their current disease state and upon which to best base treatment recommendations (including surgery). Participants also chose which of six response scales (one visual analogue scale and five Likert scales ranging from four to eight items) was easiest to use, understand, and preferred. A plurality of participants (40.0%) felt their CRS symptoms' current state was best reflected by a 1-month recall period. However, most patients (56.9%) preferred treatment recommendations to be determined by symptoms experienced over a>1 month period. The four- and five-item Likert scales were the easiest to understand (26.0% and 25.4%, respectively) and use (23.4% and 26.7%, respectively). The five-item (26.4% rating it most preferred and 70.9% rating it preferred) and four-item Likert (22.3% rating it most preferred and 56.4% rating it preferred) response scales were most preferred. Future PROMs for CRS should consider assessment of symptoms over a 1-month period and use a four- or five-item Likert response scale to reflect global patient preferences. These findings also inform interpretation of current CRS PROMs.

Content validity of the EQ-5D-5L with skin irritation and self-confidence bolt-ons in patients with atopic dermatitis: a qualitative think-aloud study.

Two bolt-on dimensions (skin irritation, self-confidence) have been developed for the EQ-5D-5L to improve its content validity and responsiveness in psoriasis. However, the two bolt-ons are not strictly psoriasis-specific and are potentially relevant in other skin conditions. This study aims to explore the content validity of the EQ-5D-5L with two bolt-ons in patients with atopic dermatitis (AD). In 2021-2022, qualitative, semi-structured interviews were conducted with 20 adult AD patients at a university dermatology clinic in Hungary. We aimed for a heterogeneous sample in terms of age, gender, education and disease severity. Patients completed the EQ-5D-5L with two bolt-ons using a think-aloud protocol. Probing questions were posed to investigate item relevance, potential conceptual overlaps, missing concepts and the appropriateness of the recall period. Interview transcripts were subjected to thematic analysis. The EQ-5D-5L with the two bolt-ons covered the most important aspects of health-related quality of life in AD patients. Most patients found both the skin irritation and self-confidence bolt-ons relevant. Fifteen potential missing concepts were identified, but only two (social relationships, judgement by others) were identified by more than one patient. A smaller conceptual overlap was found between the skin irritation and pain/discomfort dimensions in 7 patients (35%). Half the patients expressed a preference for a recall period of 1week rather than of 'today'. The EQ-5D-5L with skin irritation and self-confidence bolt-ons showed good relevance, comprehensiveness and comprehensibility in patients with AD. However, in terms of comprehensiveness, social relationships and judgement by others (stigma) may be missing from the questionnaire.

Measuring the Economic Burden of Health Conditions among White-Collar Employees: A Cross-Sectional Study from Delhi-NCR.

In the past few decades, there has been a significant increase in healthcare expenditure due to the prevalence of health issues across the globe. This is primarily seen among white-collar employees due to the sedentary nature of their jobs, which affects their current earnings (Purchasing Power) directly due to the reallocation of their real income towards healthcare expenditure (Economic Burden) and indirectly by impacting work productivity through sick leaves. To measure the economic burden of disease(s) among white-collar employees, and to study the same across different socio-demographic variables. A cross-sectional study has been conducted in the region of Delhi-NCR among 357 white-collar employees. A random sampling method was adopted using a structured questionnaire. The questionnaire collected information regarding the direct and indirect costs of health conditions with a recall period of one month. The cumulative score of these monthly costs was converted to annual data to estimate the economic burden of the health conditions among the employees over a year. As compared to Communicable diseases (16.24%), Non-communicable diseases (27.17%) were more prevalent among the respondents. Compared to other diseases, the employees suffering from Heart diseases (INR 7,62,237.50), Spinal health issues (INR 1,73,625.00), and Diabetes (INR 1,64,535.71) incurred more economic burden. At a 5% significance level, no significant difference was observed in economic burden for Gender and BMI. However, the economic burden was significantly different across the categories of Age and Monthly income. A positive association can be observed in economic burden with the increasing categories of age and monthly income. With the nature of sedentary work (desk jobs), white-collar employees are at a greater risk of exposure to various NCDs than CDs and incur a significant amount of out-of-pocket expenditure to manage their health status.

Dietary diversity and associated factors among school-aged children and adolescents in Lokossa district of southern Benin: a cross-sectional study

ObjectiveThe main objective of this study was to assess the prevalence of dietary diversity and associated factors.DesignCross-sectional study.SettingLokossa district, southern Benin.ParticipantsA survey conducted in a probabilistic sample of 612 students...

Household food insecurity in South Africa from 1999 to 2021: a metrics perspective.

To review and synthesize studies on household food security in South Africa. Systematic mapping review of metrics (methodological review). Electronic databases, including EBSCOHost, Scopus and Web of Science, were searched for studies and reports on household food security in South Africa, reporting household food security published between 1999 and 2021. Searching, selecting and reporting were performed according to the PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) statement. South African households. Forty-eight articles reporting on six national surveys (one repeated annually since 2002) and forty sub-national studies meeting the inclusion criteria were selected. Various metrics, with different recall periods and ways of categorizing food security levels, were identified. Surveys that used similar metrics showed that the percentage of South African households that have experienced food insecurity and hunger has decreased over the review period yet remains concerning. However, the multitude of metrics used to assess the different components and levels of food security limits the comparability of the results to evaluate the scope and scale of the problem. There is growing support for developing multi-variable approaches for food security research in sub-Saharan Africa. Future research should focus on finding the most appropriate combination of complementary metrics that would allow comparable data while holistically capturing food security and providing insight into the causes and consequences.