An Exploratory Study of Alternative Time Frames and Descriptors for EQ-5D-5L in Obstructive Airway Diseases Using Mixed Methods.

OBJECTIVES: EQ-5D-5L with its recall time of "today" may limit its ability to capture episodic symptoms and exacerbations in chronic obstructive airway diseases (OAD). We examined whether longer time frames and changing the intensity response scales to frequency scales could improve the measurement properties of EQ-5D-5L. METHODS: We used a mixed-method design starting with in-depth interviews with 20 patients and clinicians to elicit preferred time frames using concept elicitation techniques and content analyses. We then administered the top 4 preferred variants using 1- and 4-weeks' time frames with the original intensity or an alternative frequency response scale alongside EQ-5D-5L and St George Respiratory Questionnaire to OAD patients during 2 different visits. We compared the ceiling effects and construct validity by testing a priori hypotheses in relation to St George Respiratory Questionnaire and clinical outcomes via correlation and receiver operating characteristic (ROC) analyses, respectively. Follow-up patients were categorized into "better," "stable," and "worse" groups to assess reliability using intraclass correlation coefficient (ICC) or Cohen's Kappa (k) and responsiveness using ROC analysis. RESULTS: A total of 184 patients (mean [SD] age: 54[18]; female: 37.0%) completed baseline assessments. A total of 120 patients also completed follow-up assessments (mean [SD] interval: 2.8 [1.7] months). The ceilings were lower in the variants compared with EQ-5D-5L (P < .001). Reliability of the variants were comparable to or higher than EQ-5D-5L. The c-statistic values derived from ROC analyses of the variants were consistently higher than EQ-5D-5L. CONCLUSIONS: Use of longer time frames with the original intensity or the frequency response scales may improve EQ-5D-5L's psychometric properties in OAD patients.

Testing the Impact of Variations in Administration on the Kessler Psychological Distress Scale (K10).

Self-report measures are useful in psychological research and practice, but scores may be impacted by administration methods. This study investigated whether changing the recall period (from 30 to 7 days) and response option order (from ascending to descending) alters the score distribution of the Kessler Psychological Distress Scale (K10). Participants were presented with the K10 with either different recall periods or different response option orders. There was weak evidence of lower mean K10 scores when using a 7-day recall period than when using the 30-day recall period (B = 1.96, 95% CI [0.04-3.90]) but no evidence of a change in the estimated prevalence of very high psychological distress. Presenting the response options in ascending order did not affect mean scores, but there was weak evidence of reduced prevalence of very high distress relative to the descending order (incidence rate ratio [IRR] = 0.60, 95% CI [0.36-0.98]). These findings suggest that varying the administration method may result in minor differences in population estimates of very high psychological distress when using the K10.

Undergoing Lung Surgery (PSA-Lung) was appropriate for symptom assessment after discharge.

PURPOSE: To examine whether a 7-day or 24-h recall period of Perioperative Symptom Assessment for Patients Undergoing Lung Surgery (PSA-Lung) was appropriate for symptom assessment after discharge. METHODS: A total of 377 patients were recruited in a cohort study of patients who underwent lung surgery. We measured patient symptoms daily and weekly using the two recall period versions of the PSA-Lung scale, respectively. The psychometric properties of both versions were calculated. Spearman rank correlation coefficients and kappa (k) coefficients were used to measure the association between items score measured by the two version scales each week. Cohen's d effect size and mixed linear model were used to measure responsiveness to change over time. RESULTS: Spearman rank correlation coefficients between the symptom scores generated by the 7-day and 24-h versions (range 0.48-0.77; all P < 0.05). The correlations increased in patients in stable condition (weekly symptom change < 2). Cronbach's α coefficients for both ratings were > 0.87 and both had good test-retest reliability. The longitudinal analysis and Cohen's d effect sizes showed that both ratings had good ability to detect changes in all items. CONCLUSION: The 7-day retrospective scale was as effective as the 24-h retrospective scale in terms of psychometric performance. In the stage where the patient's symptoms change rapidly, it is recommended to use the 24-h retrospective scale for symptom monitoring. On the contrary, in a stable state, it can be considered to use the 7-day retrospective scale for monitoring to reduce the patient's burden.

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

BACKGROUND: This 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. METHODS: We 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. RESULTS: For 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. CONCLUSIONS: This 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.

The Oxford Elbow Score demonstrated good measurement properties when used with a shortened 7-day recall period.

Background: The Oxford Elbow Score (OES) is a well-validated, elbow-specific, patient-reported outcome measure (PROM), originally assigned a 4-week recall period. For PROMs, short recall periods could have some advantages, such as optimizing validity by minimizing the negative effects of inaccurate recollection and temporal trends (increase or decrease) in symptoms over the course of the recall period. Temporal trends in elbow function can, for example, be expected to occur over 4 weeks in patients recovering from an injury or surgery. The purpose of this study was to evaluate the measurement properties of the OES using a shortened, 7-day, recall period (OES-7d). Methods: The inclusion criteria were fracture, tendon rupture or dislocation affecting the elbow, and age ≥18 years. Patients with Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) scores of ≥10 points preinjury (pre-existing upper extremity condition) or concurrent upper extremity injuries were excluded. Patients completed the OES-7d, QuickDASH, and Single Assessment Numeric Evaluation-Function for the last 7 days preinjury (T1), the first 7 days postinjury (T2) and a 7-day period 3-5 months postinjury (T3). Correlations were assessed with Spearman's rho. Analyses of construct validity (correlation between scores) and internal consistency (Cronbach's alpha) were based on T3 data. Responsiveness was assessed by correlating changes in scores (change scores) between time points. Intra-rater reliability was assessed by calculating intraclass correlation coefficients based on 2 administrations (1- to 3-week interval) of PROMs in a separate group of patients who had sustained an elbow injury 1-2 years previously. Results: Seventy-five patients (45 women) were included between May 2020 and July 2021. Their mean age was 51.7 years. At T3, Spearman's rho was -0.91 for the correlation between OES total and QuickDASH scores and 0.76 for the correlation between OES total scores and Single Assessment Numeric Evaluation-Function values (construct validity). Spearman's rho for correlation between OES total and QuickDASH change scores from T2 to T3 (T3 minus T2) was -0.85 (responsiveness for improvement) and -0.88 for change scores from T1 to T2 (T2 minus T1, responsiveness for deterioration). For the OES domains, Cronbach's alpha was 0.83 for elbow function, 0.91 for pain and 0.90 for social-psychological domains. The intraclass correlation coefficient for the OES total score was 0.96. Conclusion: The OES demonstrated good measurement properties when used with a 7-day recall period (OES-7d). These results further establish the OES as a well-validated, elbow-specific PROM and support using a 7-day recall period.

The 7-day recall period version of the Urticaria Control Test-UCT7.

BACKGROUND: The Urticaria Control Test (UCT) is a well-established, very easy to use and calculate 4-item patient-reported outcome measure to assess chronic urticaria disease control during the previous 4 weeks. Clinical trials and practice may benefit from the use of a UCT version with a shorter recall period, but this does not exist. OBJECTIVES: We sought to develop and validate a UCT version with a 7-day recall period, the UCT7. METHODS: The UCT7 was developed, based on the UCT, and tested, in 152 patients with chronic urticaria (spontaneous: n = 101, inducible: n = 51) for its reliability, validity and screening accuracy, and clinimetric properties, in other words, the cutoff for well-controlled disease and the minimal clinically important difference. RESULTS: The UCT7 showed excellent internal consistency reliability with a Cronbach αvalue of 0.91 and test-retest reliability with an intraclass correlation coefficient of 0.83. Convergent validity was high and strongly correlated with anchors of disease control, wheal and angioedema frequency, and urticaria-related quality of life impairment. The UCT7 showed excellent sensitivity to change; however, changes in angioedema activity and impact did not correlate well with changes in UCT7. Based on receiver-operating characteristic curve analysis, the proportion of correctly classified patients, and patients' assessment of treatment efficacy, we recommend a cutoff value of 12 points for identifying patients with well-controlled disease. The UCT7 minimal clinically important difference for improvement was estimated to be 2 points. CONCLUSIONS: The UCT7 is a validated 7-day recall period version of the UCT. It is ideal for the assessment of disease control at short intervals in patients with chronic urticaria in clinical studies and practice.

Heterogeneity of definitions and measurements of binge drinking in research on adolescents and young adults.

INTRODUCTION: Binge drinking is a widespread health compromising behaviour among adolescents and young adults and is one of the leading causes of mortality and injuries among this population. The definitions and measurement methods of binge drinking are heterogeneous but constitute a crucial component in the literature on associated factors related to binge drinking. This study focused on how binge drinking is defined and measured in the literature exploring its associated risk factors among adolescents and young adults. METHODS: The databases PubMed, Embase, PsycINFO and Social Care were searched for articles published between 1 January 2006 and 30 April 2020 using 3 concepts: binge drinking; risk or protective factors; and adolescents/young adults with respective key words. Data were extracted on the main characteristics of studies and the parameters of binge drinking measurements. RESULTS: 173 studies were included, mostly cross-sectional (61 %) and longitudinal (38 %). Only 23 % of the studies explicitly referred to a standardised definition of binge drinking even though 76 % of the studies used a consensual threshold of 5 drinks or more for men. A lower threshold for women was applied in 26 % of the studies. Recall periods ranged between 2 weeks and 1 year in 85 % of the studies and only 16 % presented binge drinking in terms of frequency and/or quantity of drinks. CONCLUSION: Our results highlight the heterogeneity in the definitions and measurements of binge drinking, raising concerns for meaningful comparisons between studies focused on factors associated with the behaviour. The scientific community needs to be aware of these variations and address the gap of poor stratification and inconsistencies in binge drinking reporting.

Do You Recall?: Results From a Within-Person Recall Study of the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v2.0 - Physical Function 8c.

OBJECTIVES: This study aimed to determine whether responses to Patient-Reported Outcomes Measurement Information System Short Form v2.0 - Physical Function 8c (PROMIS PF8c) items differed when the use of a 7-day recall period was compared with no specified recall period. METHODS: Using a within-subject design, we surveyed 1810 individuals from the US general population, administering PROMIS PF8c at survey beginning and end. The order of measure presentation was randomly assigned. We calculated recall difference scores (RDSs) as no recall score minus 7-day recall score using both item response theory-based T scores and raw summed scores. We examined the distribution and created Bland-Altman plots for both RDSTscore and RDSRaw. We also calculated correlations between no recall versus 7-day recall T score and raw scores. Finally, we determined whether differences in no recall versus 7-day recall scores were associated with patient-reported PF. RESULTS: RDSTscore and RDSRaw had means (root mean square differences) of 0.00 (5.43) and -0.04 (3.79), respectively. The vast majority (%) of RDSTscore and RDSRaw values fell between the Bland-Altman limits of agreement (-10.65 to 10.66 and -7.46 to 7.38, respectively). Pearson's correlations between no recall and 7-day recall for T scores and raw scores were 0.88 and 0.87, respectively. Effect sizes for mean RDSTscore and RDSRaw compared across level of Eastern Oncology Cooperative Group performance status, patient global impression of PF severity, and single PF items were near 0. CONCLUSIONS: We did not find any significant recall period effect on PF8c responses. Therefore, we recommend the use of the PROMIS physical function standard, with no specified recall time period.

Patient perspectives on recall period and response options in patient-reported outcome measures for chronic rhinosinusitis symptomatology: A pilot study.

OBJECTIVE: Patient-reported outcome measures (PROMs) for assessment of chronic rhinosinusitis (CRS) employ a variety of recall periods and response scales for reporting CRS symptom burden. CRS patient perspective is unknown with respect to recall periods and response scales in PROMs. DESIGN: Cross-sectional study. SETTING: Tertiary rhinology clinic. PARTICIPANTS: Sixty three adults with CRS. MAIN OUTCOME MEASURES: Participants were asked to choose which CRS symptom recall period-1 day, 2 weeks, 1 month or greater than 1 month-was most reflective of their current disease state and best to base treatment recommendations (including surgery) upon. Participants were also asked to report which of six response scales (one visual analogue scale [VAS] and five Likert scales ranging from four to eight items) were easiest to use and understand, and most preferred. RESULTS: A majority of participants felt the current state of their CRS symptoms was best reflected by a recall period of 2 weeks to 1 month; however, patients preferred that recommendations about treatments, including endoscopic sinus surgery, be determined by symptoms experienced over at least a one-month period. Participants generally found the VAS and seven-item Likert scale to be the easiest to use and understand, and their most preferred scales. No patient characteristics associated with preferences for recall periods or response scales. CONCLUSION: Future PROMs for CRS symptoms should consider assessment of symptoms over a one-month time frame and use either a VAS or seven-item Likert response scale to optimally balance reflection of current disease state, need for intervention and patient preference.

New Developments in the Use of Patient-Reported Outcomes in Cancer Patients Undergoing Immunotherapies.

In a previous chapter, how best to measure symptoms was discussed, the desirable properties of a psychometrically valid symptom assessment tool were listed, available symptom assessment tools were reviewed, methods to assist in the interpretation of patient-reported outcomes (PRO) data were provided, and the current use of PROs in immunotherapy was described. Two areas for further research were also identified. These two areas were (1) deciding on the frequency of administration of symptom assessment and (2) determining the adequacy of the chosen symptom list to cover both known and unknown effects of immunotherapy. This brief update provides new developments on these two critical issues that are of significant concerns to researchers and clinicians who are investigating the use of immunotherapies either singly or in combination in cancer patients.

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

PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Evaluation of the 3-day recall period for the Functional Life Index-Emesis (FLIE).

BACKGROUND: Nausea and vomiting are commonly experienced by cancer patients, and can be assessed by the Functional Life Index-Emesis (FLIE) instrument which employs a three-day recall period. However, it is unknown whether patients' responses to the FLIE better correlate with the average or the worst symptom severity of the recall period, or the severity of an individual day. METHODS: Patients receiving emetogenic radiotherapy for painful bone metastases who were enrolled in one of three trials for anti-emetic medications (ondansetron, aprepitant/granisetron, or palonosetron) completed the FLIE at baseline, and days 3, 5, 7, or 10 during treatment and follow-up. The concordance correlation coefficient (rc) was calculated between FLIE overall nausea and vomiting and daily nausea, vomiting, and quality of life (QoL) using the average responses of the 3-day recall period and with each of the three days' responses. RESULTS: Responses from eighty-nine patients who experienced nausea or vomiting were analysed. The highest concordance for FLIE nausea was with the 3-day average [during treatment: rc =0.698, 95% confidence interval (CI): 0.495, 0.829; follow-up: rc =0.821, 95% CI: 0.711, 0.892]. FLIE vomiting had the highest concordance with worst day vomiting (during treatment, rc =0.310, 95% CI: 0.194, 0.417) or two day-prior vomiting (follow-up, rc =0.902, 95% CI: 0.832, 0.944). FLIE nausea and vomiting had inconsistent concordances with daily assessments of QoL. CONCLUSIONS: Responses to the FLIE questionnaire are most representative of average nausea severity. Larger cohorts to validate these findings are warranted to address the lack of power in this present study and to confirm the wording and justification of a three-day recall period for the FLIE.

Assessing health status over time: impact of recall period and anchor question on the minimal clinically important difference of copd health status tools.

BACKGROUND: The Minimal Clinically Important Difference (MCID) assesses what change on a measurement tool can be considered minimal clinically relevant. Although the recall period can influence questionnaire scores, it is unclear if it influences the MCID. This study is the first to examine longitudinally the impact of the recall period of an anchor question and its design on the MCID of COPD health status tools using the COPD Assessment Test (CAT), Clinical COPD Questionnaire (CCQ) and the St. George's Respiratory Questionnaire (SGRQ). METHODS: Moderate to very severe COPD patients without respiratory co-morbidities were recruited during 3-week Pulmonary Rehabilitation (PR). CAT, CCQ and SGRQ were completed at baseline, discharge, 3, 6, 9 and 12 months. A 15-point Global Rating of Change scale (GRC) was completed at each follow-up. A five-point GRC was used as second anchor at 12 months. Mean change scores of a subset of patients indicating a minimal improvement on each of the anchor questions were considered the MCID. The MCID estimates over different time periods were compared with one another by evaluating the degree of overlap of Confidence Intervals (CI) adjusted for dependency. RESULTS: In total 451 patients were included (57.9 ± 6.6 years, 65% male, 50/39/11% GOLD II/III/IV), of which 309 completed follow-up. Baseline health status scores were 20.2 ± 7.3 (CAT), 2.9 ± 1.2 (CCQ) and 50.7 ± 17.3 (SGRQ). MCID estimates for improvement ranged - 3.1 to - 1.4 for CAT, - 0.6 to - 0.3 for CCQ, and - 10.3 to - 7.6 for SGRQ. Absolute higher - though not significant - MCIDs were observed for CAT and CCQ directly after PR. Significantly absolute lower MCID estimates were observed for CAT (difference - 1.4: CI -2.3 to - 0.5) and CCQ (difference - 0.2: CI -0.3 to -0.1) using a five-point GRC. CONCLUSIONS: The recall period of a 15-point anchor question seemed to have limited impact on the MCID for improvement of CAT, CCQ and SGRQ during PR; although a 3-week MCID estimate directly after PR might lead to absolute higher values. However, the design of the anchor question was likely to influence the MCID of CAT and CCQ. TRIAL REGISTRATION: RIMTCORE trial # DRKS00004609 and #12107 (Ethik-Kommission der Bayerischen Landesärztekammer).

Evaluation of different recall periods for the US National Cancer Institute's PRO-CTCAE.

AIMS: The US National Cancer Institute recently developed the PRO-CTCAE (Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events). PRO-CTCAE is a library of questions for clinical trial participants to self-report symptomatic adverse events (e.g. nausea). The objective of this study is to inform evidence-based selection of a recall period when PRO-CTCAE is included in a trial. We evaluated differences between 1-, 2-, 3-, and 4-week recall periods, using daily reporting as the reference. METHODS: English-speaking patients with cancer receiving chemotherapy and/or radiotherapy were enrolled at four US cancer centers and affiliated community clinics. Participants completed 27 PRO-CTCAE items electronically daily for 28 days, and then weekly over 4 weeks, using 1-, 2-, 3-, and 4-week recall periods. For each recall period, mean differences, effect sizes, and intraclass correlation coefficients were calculated to evaluate agreement between the maximum of daily ratings and the corresponding ratings obtained using longer recall periods (e.g. maximum of daily scores over 7 days vs 1-week recall). Analyses were repeated using the average of daily scores within each recall period rather than the maximum of daily scores. RESULTS: A total of 127 subjects completed questionnaires (57% male; median age: 57). The median of the 27 mean differences in scores on the PRO-CTCAE 5-point response scale comparing the maximum daily versus the longer recall period (and corresponding effect size) was -0.20 (-0.20) for 1-week recall, -0.36 (-0.31) for 2-week recall, -0.45 (-0.39) for 3-week recall, and -0.47 (-0.40) for 4-week recall. The median intraclass correlation across 27 items between the maximum of daily ratings and the corresponding longer recall ratings for 1-week recall was 0.70 (range: 0.54-0.82), for 2-week recall was 0.74 (range: 0.58-0.83), for 3-week recall was 0.72 (range: 0.61-0.84), and for 4-week recall was 0.72 (range: 0.64-0.86). Similar results were observed for all analyses using the average of daily scores rather than the maximum of daily scores. CONCLUSION: A 1-week recall corresponds best to daily reporting. Although intraclass correlations remain stable over time, there are small but progressively larger differences between daily and longer recall periods at 2, 3, and 4 weeks, respectively. The preferred recall period for the PRO-CTCAE is the past 7 days, although investigators may opt for recall periods of 2, 3, or 4 weeks with an understanding that there may be some information loss.

Predicting Productivity Losses from Health-Related Quality of Life Using Patient Data.

OBJECTIVE: This paper estimates productivity loss using the health of the patient in order to allow indirect estimation of these costs for inclusion in economic evaluation. METHODS: Data from two surveys of inpatients [Health outcomes data repository (HODaR) sample (n = 42,442) and health improvement and patient outcomes (HIPO) sample (n = 6046)] were used. The number of days off paid employment or normal activities (excluding paid employment) was modelled using the health of the patients measured by the EQ-5D, international classification of diseases (ICD) chapters, and other health and sociodemographic data. Two-part models (TPMs) and zero-inflated negative binomial (ZINB) models were identified as the most appropriate specifications, given large spikes at the minimum and maximum days for the dependent variable. Analysis was undertaken separately for the two datasets to account for differences in recall period and identification of those who were employed. RESULTS: Models were able to reflect the large spike at the minimum (zero days) but not the maximum, with TPMs doing slightly better than the ZINB model. The EQ-5D was negatively associated with days off employment and normal activities in both datasets, but ICD chapters only had statistically significant coefficients for some chapters in the HODaR. CONCLUSIONS: TPMs can be used to predict productivity loss associated with the health of the patient to inform economic evaluation. Limitations include recall and response bias and identification of who is employed in the HODaR, while the HIPO suffers from a small sample size. Both samples exclude some patient groups.

Validation of the 4 week recall version of the Uterine Fibroid Symptom and Health-related Quality of Life (UFS-QOL) Questionnaire.

OBJECTIVE: To assess the psychometric performance of the 4 week recall version of the Uterine Fibroid Symptom and Health-related Quality of Life Questionnaire (UFS-QoL), a patient measure of the severity of uterine fibroid (UF) symptoms and their impact on health-related quality of life (HRQL). METHODS: This was a retrospective analysis of phase 2a data from pre-menopausal women with heavy menstrual bleeding associated with UF. Participants completed the UFS-QoL at Baseline, Treatment Month 3, and Follow-up Month 3 and a daily diary with a Menstrual Bleeding Scale and the UF Daily Symptom Scale throughout the study duration. Descriptive statistics were performed on patient demographic characteristics; analyses were conducted to assess the internal consistency reliability, validity, and responsiveness of the UFS-QoL 4 week recall version. RESULTS: A total of 271 women were enrolled with a mean age of 41.8 years; 74% were black. The UFS-QoL demonstrated excellent internal consistency reliability, with Cronbach's alpha coefficient values >0.70 for each subscale at each study visit. Results indicated good concurrent validity with the UF Daily Symptom Scale items. The women with amenorrhea at Treatment Month 3 had significantly better scores on all UFS-QoL subscales and HRQL Total than women with menstrual bleeding, indicating acceptable discriminant validity. Mean subscale change scores from Baseline to Treatment Month 3 were 19.2 to 39.8. Effect sizes were moderate to large (0.53 to 1.86), demonstrating responsiveness to change. LIMITATIONS: As this study is a post hoc validation of the 4 week recall UFS-QOL, it is limited to the clinical trial data available and does not include a direct comparison to the 3 month recall version of UFS-QOL. CONCLUSIONS: The 4 week recall version of the UFS-QoL demonstrated good internal consistency reliability, concurrent validity, and responsiveness and is psychometrically comparable to the original 3 month recall UFS-QoL. CLINICAL TRIAL REGISTRATION: Data from a phase 2a, cohort design proof of concept study (trial M12-663); ClinicalTrials.gov identifier NCT01441635. Date of Registration: 6 September 2011.

What is the optimal recall period for verbal autopsies? Validation study based on repeat interviews in three populations.

BACKGROUND: One key contextual feature in Verbal Autopsy (VA) is the time between death and survey administration, or recall period. This study quantified the effect of recall period on VA performance by using a paired dataset in which two VAs were administered for a single decedent. METHODS: This study used information from the Population Health Metrics Research Consortium (PHMRC) Study, which collected VAs for "gold standard" cases where cause of death (COD) was supported by clinical criteria. This study repeated VA interviews within 3-52 months of death in PHMRC study sites in Andhra Pradesh, India, and Bohol and Manila, Philippines. The final dataset included 2113 deaths interviewed twice and with recall periods ranging from 0 to 52 months. COD was assigned by the Tariff method and its accuracy determined by comparison with the gold standard COD. RESULTS: The probability of a correct diagnosis of COD decreased by 0.55 % per month in the period after death. Site of data collection and survey module also affected the probability of Tariff Method correctly assigning a COD. The probability of a correct diagnosis in VAs collected 3-11 months after death will, on average, be 95.9 % of that in VAs collected within 3 months of death. CONCLUSIONS: These findings suggest that collecting VAs within 3 months of death may improve the quality of the information collected, taking the need for a period of mourning into account. This study substantiates the WHO recommendation that it is reasonable to collect VAs up to 1 year after death providing it is accepted that probability of a correct diagnosis is likely to decline month by month during this period.

Proctitis 1 Week after Stereotactic Body Radiation Therapy for Prostate Cancer: Implications for Clinical Trial Design.

BACKGROUND: Proctitis following prostate cancer radiation therapy is a primary determinant of quality of life (QOL). While previous studies have assessed acute rectal morbidity at 1 month after stereotactic body radiotherapy (SBRT), little data exist on the prevalence and severity of rectal morbidity within the first week following treatment. This study reports the acute bowel morbidity 1 week following prostate SBRT. MATERIALS AND METHODS: Between May 2013 and August 2014, 103 patients with clinically localized prostate cancer were treated with 35-36.25 Gy in five fractions using robotic SBRT delivered on a prospective clinical trial. Bowel toxicity was graded using the Common Terminology Criteria for Adverse Events version 4.0 (CTCAEv.4). Bowel QOL was assessed using the EPIC-26 questionnaire bowel domain at baseline, 1 week, 1 month, and 3 months. Time-dependent changes in bowel symptoms were statistically compared using the Wilcoxon signed-rank test. Clinically significant change was assessed by the minimally important difference (MID) in EPIC score. This was defined as a change of 1/2 standard deviation (SD) from the baseline score. RESULTS: One-hundred and three patients with a minimum of 3 months of follow-up were analyzed. The cumulative incidence of acute grade 2 gastrointestinal (GI) toxicity was 23%. There were no acute ≥ grade 3 bowel toxicities. EPIC bowel summary scores maximally declined at 1 week after SBRT (-13.9, p < 0.0001) before returning to baseline at 3 months after SBRT (+0.03, p = 0.94). Prior to treatment, 4.9% of men reported that their bowel bother was a moderate to big problem. This increased to 28.4% (p < 0.0001) 1 week after SBRT and returned to baseline at 3 months after SBRT (0.0%, p = 0.66). Only the bowel summary and bowel bother score declines at 1 week met the MID threshold for clinically significant change. CONCLUSION: The rate and severity of acute proctitis following prostate SBRT peaked at 1 week after treatment and returned to baseline by 3 months. Toxicity assessment at 1 week can therefore minimize recall bias and should aid in the design of future clinical trials focused on accurately capturing and minimizing acute morbidity following SBRT.

Validity of self-reported hospital admissions in clinical trials depends on recall period length and individual characteristics.

RATIONALE, AIMS AND OBJECTIVES: We investigated the validity of self-reported admission data compared to administrative records in a clinical trial. METHOD: In the randomized KORINNA study (ISRCTN02893746), hospital admission data were collected in telephone interviews with 273 elderly patients quarterly over a 1-year period and thereafter annually over a 2-year period. Data were compared with administrative records and discharge letters. Mixed models were used to investigate if recall period and individual characteristics influence validity. RESULTS: Specificity (>99%) and sensitivity (94%) of self-reported data did not differ for different recall periods (3 months vs. 12 months). The differences between self-reported and registered inpatient days were not statistically significant. Having regard to all the admissions within the time period of last interview and dropping out, the bias was up to 40% underestimation. The chance of disagreement was significantly smaller [odds ratio (OR) of misremember an admission = 0.596, P = 0.049, confidence interval (CI) = 0.355 to 1.00; OR of misremember length of stay = 0.521, P = 0.002, CI = 0.344 to 0.789] for 3-month periods, but this was primarily driven by number of admissions within the recall period. Individuals with better health and longer stays had a significantly smaller chance of disagreement. CONCLUSIONS: The bias within one year was not influenced by applying various recall periods, although the probability of correctly self-reported single hospital admission was higher using a recall period of three months. It can be recommended that lengthened recall periods of 12 months are appropriate for gathering self-reported hospital admission data in elderly people with myocardial infarction.

Unique Challenges in Development, Psychometric Evaluation, and Interpretation of Daily and Event Diaries as Endpoints in Clinical Trials.

By bringing data collection closer to real time and minimizing recall bias, patient diaries or event-driven logs offer substantial benefits over retrospective questionnaires for many patient-reported disease concepts. Such assessments are increasingly used to support primary and secondary endpoints in randomized controlled trials. These diaries have the potential to provide more reliable and valid assessment of patients' subjective experiences of symptoms and disease events. However, use of such diaries presents significant and unique challenges depending on the context of use. Of note, while symptom-related label claims are those most frequently granted by regulatory authorities, no guidance specific to support the development, psychometric evaluation, and interpretation of endpoints derived from patient diaries exists. This article provides an overview of key methodological, statistical, and clinical considerations for implementation of patient diaries with a regulatory perspective in mind. Approaches and solutions covered in this article include (1) techniques to establish content validity based on obtaining qualitative insights in naturalistic settings and real-life experience of diary completion, (2) demonstration of psychometric properties with respect to day-to-day variability, and (3) aggregation of data from multiple days/events to move from items to endpoints. The importance of the patients' engagement is highlighted in order to help overcome these challenges throughout all stages of diary and endpoint development and evaluation. This article can inform researchers who are developing or implementing patient diaries as clinical trial endpoints to ensure that the nuances of this mode of data collection are considered in the development of endpoints and prior to regulatory interactions.