Agreement of medical record abstraction and self-report of breast cancer treatment with an extended recall window.

BACKGROUND: Medical record abstraction (MRA) and self-report questionnaires are two methods frequently used to ascertain cancer treatment information. Prior studies have shown excellent agreement between MRA and self-report, but it is unknown how a recall window longer than 3 years may affect this agreement. METHODS: The Women's Environmental Cancer and Radiation Epidemiology (WECARE) Study is a multicenter, population-based case-control study of controls with unilateral breast cancer individually matched to cases with contralateral breast cancer. Participants who were diagnosed with a first primary breast cancer from 1985 to 2008 before the age of 55 years completed a questionnaire that included questions on treatment. First primary breast cancer treatment information was abstracted from the medical record from radiation oncology clinic notes for radiation treatment and from systemic adjuvant treatment reports for hormone therapy and chemotherapy. Agreement between MRA and self-reported treatment was assessed with the kappa statistic and corresponding 95% confidence intervals (CIs). RESULTS: A total of 2808 participants with MRA and self-reported chemotherapy treatment information, 2733 participants with MRA and self-reported hormone therapy information, and 2905 participants with MRA and self-reported radiation treatment information were identified. The median recall window was 12.5 years (range, 2.8-22.2 years). MRA and self-reported treatment agreement was excellent across treatment modalities (kappachemo, 98.5; 95% CI, 97.9-99.2; kappahorm, 87.7; 95% CI, 85.9-89.5; kapparad, 97.9; 95% CI, 97.0-98.7). There was no heterogeneity across recall windows (pchemo = .46; phorm = .40; prad = .61). CONCLUSIONS: Agreement between self-reported and MRA primary breast cancer treatment modality information was excellent for young women diagnosed with breast cancer and was maintained even among women whose recall window was more than 20 years after diagnosis.

Two models of mind blanking.

Mind blanking is a mental state in which attention does not bring any perceptual input into conscious awareness. As this state is still largely unexplored, we suggest that a comprehensive understanding of mind blanking can be achieved through a multifaceted approach combining self-assessment methods, neuroimaging and neuromodulation. In this article, we explain how electroencephalography and transcranial magnetic stimulation could be combined to help determine whether mind blanking is associated with a lack of mental content or a lack of linguistically or conceptually determinable mental content. We also question whether mind blanking occurs spontaneously or intentionally and whether these two forms are instantiated by the same or different neural correlates.

The assessment of emotion reactivity: The Italian validation of the Perth Emotional Reactivity Scale-Short Form (PERS-S).

Emotion reactivity refers to the activation, intensity and duration of emotional responses to internal or external stimuli. It can be differentiated from emotion regulation since the former is the very first response to an emotional trigger, and the latter can be defined as a tool for maintaining one's arousal in a window of tolerance. Since, to date, there are no Italian self-report measures able to evaluate individuals' emotional reactivity, this study aimed to contribute to the Italian validation of the Perth Emotional Reactivity Scale-Short Form (PERS-S). The PERS-S is an 18-item self-report measure answered on a 5-point Likert scale that generates six subscale scores and two composite scores, with higher scores indicating higher levels of reactivity. Data from 768 individuals showed that the PERS-S had good to excellent goodness of fit. The internal consistency was high, with an overall reliability coefficient (Cronbach's α) of .87 and .86 for the negative and positive general scales, respectively. The PERS-S also demonstrated appropriate convergent validity, showing significant correlations with conceptually related measures, and acceptable divergent validity, showing minimal correlations with unrelated constructs. Finally, we evaluated the Test-Retest Reliability by administering the PERS-S to the same sample twice, with a 2-week interval. The significant correlations between the two PERS-S administrations suggest temporal stability. The Italian version of the PERS-S will enrich the repertoire of self-report measures for investigating the development and risk factors of mental health disorders and may have practical applications in clinical settings.

Measures of Subjective Memory for People with Epilepsy: A Systematic Review of Measurement Properties.

People with epilepsy frequently express concern about the burden of memory problems in their everyday lives. Self-report memory questionnaires may provide valuable insight into individuals' perceptions of their everyday memory performance and changes over time. Yet, despite their potential utility, the measurement properties of self-report memory questionnaires have not been evaluated in epilepsy. This systematic review aimed to provide a critical appraisal of the measurement properties of self-report memory questionnaires for adults with epilepsy. Following protocol registration (PROSPERO CRD42020210967), a systematic search of PubMed, EMBASE, Web of Science, CINAHL, and PsychInfo from database inception until 27 May 2021 was conducted. Eligible studies were published in English-language peer-reviewed journals, recruited adults with epilepsy, and reported on the development or evaluation of the measurement properties of a self-report memory questionnaire. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology was used to evaluate each study of a measurement property, and results were qualitatively synthesised. In total, 80 articles and one test manual were located containing 153 studies of measurement properties pertinent to 23 self-report memory questionnaires. Overall, no scale could be recommended outright for the evaluation of subjective memory symptoms in adults with epilepsy. This was due to the near absence of dedicated content validation studies relevant to this population and shortcomings in the methodology and scientific reporting of available studies of structural validity. Recommendations to support the advancement and psychometric validation of self-report memory questionnaires for people with epilepsy are provided.

Undetected suicide attempts among U.S. soldiers: results from the Army Study to Assess Risk and Resilience in Servicemembers (Army STARRS).

BACKGROUND: While previous studies have reported high rates of documented suicide attempts (SAs) in the U.S. Army, the extent to which soldiers make SAs that are not identified in the healthcare system is unknown. Understanding undetected suicidal behavior is important in broadening prevention and intervention efforts. METHODS: Representative survey of U.S. Regular Army enlisted soldiers (n = 24 475). Reported SAs during service were compared with SAs documented in administrative medical records. Logistic regression analyses examined sociodemographic characteristics differentiating soldiers with an undetected SA v. documented SA. Among those with an undetected SA, chi-square tests examined characteristics associated with receiving a mental health diagnosis (MH-Dx) prior to SA. Discrete-time survival analysis estimated risk of undetected SA by time in service. RESULTS: Prevalence of undetected SA (unweighted n = 259) was 1.3%. Annual incidence was 255.6 per 100 000 soldiers, suggesting one in three SAs are undetected. In multivariable analysis, rank ⩾E5 (OR = 3.1[95%CI 1.6-5.7]) was associated with increased odds of undetected v. documented SA. Females were more likely to have a MH-Dx prior to their undetected SA (Rao-Scott χ21 = 6.1, p = .01). Over one-fifth of undetected SAs resulted in at least moderate injury. Risk of undetected SA was greater during the first four years of service. CONCLUSIONS: Findings suggest that substantially more soldiers make SAs than indicated by estimates based on documented attempts. A sizable minority of undetected SAs result in significant injury. Soldiers reporting an undetected SA tend to be higher ranking than those with documented SAs. Undetected SAs require additional approaches to identifying individuals at risk.

Posttraumatic stress disorder (PTSD) prevalence: an umbrella review.

Posttraumatic stress disorder (PTSD) is one of the most serious and incapacitating mental diseases that can result from trauma exposure. The exact prevalence of this disorder is not known as the literature provides very different results, ranging from 2.5% to 74%. The aim of this umbrella review is to provide an estimation of PTSD prevalence and to clarify whether the prevalence depends on the assessment methods applied (structured interview v. self-report questionnaire) and on the nature of the traumatic event (interpersonal v. not-interpersonal). A systematic search of major databases and additional sources (Google Scholar, EBSCO, Web of Science, PubMed, Galileo Discovery) was conducted. Fifty-nine reviews met the criteria of this umbrella review. Overall PTSD prevalence was 23.95% (95% confidence interval 95% CI 20.74-27.15), with no publication bias or significant small-study effects, but a high level of heterogeneity between meta-analyses. Sensitivities analyses revealed that these results do not change after removing meta-analysis also including data from underage participants (23.03%, 95% CI 18.58-27.48), nor after excluding meta-analysis of low quality (24.26%, 95% CI 20.46-28.06). Regarding the impact of diagnostic instruments on PTSD prevalence, the results revealed a lack of significant differences in PTSD prevalence when structured v. self-report instruments were applied (p = 0.0835). Finally, PTSD prevalence did not differ following event of intentional (25.42%, 95% CI 19.76-31.09) or not intentional (22.48%, 95% CI 17.22-27.73) nature (p = 0.4598). The present umbrella review establishes a robust foundation for future research and provides valuable insights on PTSD prevalence.

The Vaginal Penetration Skills Scale (VPSS): a paradigm shift in genito-pelvic pain/penetration disorder screening, assessment, and stratification.

BACKGROUND: Receptive vaginal penetration skills have been implicated in the etiology, explanatory models, and treatment of genito-pelvic pain penetration disorder (GPPPD). However, there are no psychometric skills measures designed to screen, assess, and stratify GPPPD. AIM: We aimed to develop and psychometrically evaluate a new scale-the Vaginal Penetration Skills Scale (VPSS)-to screen, assess, and stratify GPPPD. METHODS: This study included 148 Brazilian females with GPPPD symptoms (113 lifelong and 35 acquired) and 251 Brazilian females without sexual complaints. We conducted factor analyses considering all participants (n = 399). Then, we conducted latent class analysis within the GPPPD group to identify clusters of individuals with similar VPSS profiles. We assessed convergent validity through intercorrelation with the Brazilian versions of the Female Genital Self-Image Scale (FGSIS) and the 6-item Female Sexual Function Index (FSFI-6). OUTCOMES: We developed complete and short-form versions of the VPSS (VPSS-29 and VPSS-SF11, respectively), each with 3 dimensions, to screen, assess, and stratify GPPPD. RESULTS: Factor analysis yielded a 3-factor VPSS model with the "Nonsexual Genital Self-Exploration," "Nonsexual Vaginal Penetration Skills," and "Sexual Vaginal Penetration Skills" dimensions for both VPSS versions. The reliability was excellent for the VPSS-29 (ω = 0.981, α = 0.981) and the VPSS-SF11 (ω = 0.959, α = 0.961). All 3 dimensions could detect significant differences between patients with GPPPD and healthy females. They also differentiated the patients with GPPPD, distinguishing gradient levels. For convergent validity, we found moderate to strong correlations (rho = 0.715-0.745) between the VPSS, FGSIS, and FSFI-6. CLINICAL IMPLICATIONS: The VPSS can be applied easily in both clinical and research settings. STRENGTHS AND LIMITATIONS: The VPSS provides a concise and thorough evaluation of receptive vaginal penetration skills in both sexual and nonsexual contexts among patients with GPPPD. The sample had limited diversity regarding gender and sexual orientation; therefore, it is important to validate the use of this scale in populations beyond the cisgender heterosexual female population to ensure its applicability in diverse settings. CONCLUSION: These results support the reliability and psychometric validity of the VPSS as a self-report measure to screen, assess, and stratify GPPPD symptoms.

Sleep characteristics and parameters of bone turnover and strength in the adult population: results from the Study of Health in Pomerania-TREND.

Poor sleep quality or sleep deprivation may be related to decreased bone mineral density. We aimed to assess whether associations of sleep characteristics and bone turnover or strength are present in adults from the general population and whether these are independent of common risk factors such as sex, age, and obesity. A total of 1037 participants from the Study of Health in Pomerania-TREND underwent laboratory-based polysomnography and quantitative ultrasound measurements at the heel. Of these participants, 804 completed standardised questionnaires to assess daytime sleepiness, insomnia, and sleep quality. Serum concentrations of two bone turnover markers, intact amino-terminal propeptide of type 1 procollagen (P1NP) and carboxy-terminal telopeptide of type 1 collagen (CTX) were measured. Cross-sectional associations of polysomnography variables (total sleep time, sleep efficiency, time spent wake after sleep onset, oxygen desaturation index, apnea-hypopnea index, and obstructive sleep apnea [OSA]), as well as sleep questionnaire scores with the bone turnover markers and the ultrasound-based stiffness index were assessed in linear regression models. In adjusted models, higher insomnia scores and lower sleep quality scores were related to a higher bone turnover in women but not in men. However, associations between polysomnography variables or questionnaire scores and the stiffness index were absent. Our study provides limited evidence for relationships between sleep characteristics and bone turnover and strength independent of common risk factors for OSA and osteoporosis. Nevertheless, women reporting poor sleep or insomnia in combination with risk factors for osteoporosis might benefit from an evaluation of bone health.

Network analysis of sleep bruxism in the EPISONO adult general population.

Sleep bruxism (SB) has been associated with biological and psychosocial factors. The assessment of SB includes self-report, clinical evaluation, and polysomnography. This study aimed to investigate the associations of self-reported SB with other sleep disorders and demographic, psychological, and lifestyle factors in the adult general population, and to investigate whether self-reported SB and polysomnographically (PSG) confirmed SB provide similar outcomes in terms of their associated factors. We recruited 915 adults from the general population in Sao Paulo, Brazil. All participants underwent a one-night PSG recording and answered questions about sex, age, BMI, insomnia, OSA risk, anxiety, depression, average caffeine consumption, smoking frequency, and alcohol consumption frequency. We investigated the link between SB and the other variables in univariate, multivariate, and network models, and we repeated each model once with self-reported SB and once with PSG-confirmed SB. Self-reported SB was only significantly associated with sex (p = 0.042), anxiety (p = 0.002), and depression (p = 0.03) in the univariate analysis, and was associated with insomnia in the univariate (p < 0.001) and multivariate (ß = 1.054, 95%CI 1.018-1.092, p = 0.003) analyses. Network analysis showed that self-reported SB had a direct positive edge to insomnia, while PSG-confirmed SB was not significantly associated with any of the other variables. Thus, sleep bruxism was positively associated with insomnia only when self-reported, while PSG-confirmed SB was not associated with any of the included factors.

The PompeQoL questionnaire: Development and validation of a new measure for children and adolescents with Pompe disease.

Genetic disorders pose great challenges for affected individuals and their families, as they must cope with the irreversible nature of the disease and a life-long dependence on medical assistance and treatment. Children and adolescents dealing with Pompe disease (PD) often struggle to keep up with their peers in physical activities. To gain valuable insights into their subjective experiences and better understand their perception and coping related to daily challenges linked to their condition and treatment, the use of standardized questionnaires is crucial. This study introduces the novel PompeQoL 1.0 questionnaire for children and adolescents with PD, designed for comprehensive assessment of both disease-specific FDH and HRQoL through self- and proxy reports. Content validity was ensured through patients' and parents' involvement at the initial stages of development and in subsequent cognitive debriefing process. Participants found the questionnaire easy to understand, answerable, relevant, and comprehensive. Adjustments based on feedback from patients and their parents improved its utility as a patient- and observer-reported outcome measure. After careful item examination, 52 items were selected, demonstrating moderate to excellent test-retest reliability for most scales and initial evidence for satisfactory construct validity. The PompeQoL questionnaire stands as a valuable screening instrument for both clinical and research purposes. Future research should prioritize additional revisions and larger validation studies, focusing on testing the questionnaire in clinical practice and trials. Nevertheless, the PompeQoL 1.0 stands out as the first standardized measure providing insights into disease-specific FDH and HRQoL among children and adolescents with various forms of PD.

Reliability and validity of rapid assessment tools for measuring 24-hour movement behaviours in children aged 0-5 years: the Movement Behaviour Questionnaire Baby (MBQ-B) and child (MBQ-C).

BACKGROUND: The development of validated "fit-for-purpose" rapid assessment tools to measure 24-hour movement behaviours in children aged 0-5 years is a research priority. This study evaluated the test-retest reliability and concurrent validity of the open-ended and closed-ended versions of the Movement Behaviour Questionnaire for baby (MBQ-B) and child (MBQ-C). METHODS: 300 parent-child dyads completed the 10-day study protocol (MBQ-B: N = 85; MBQ-C: N = 215). To assess validity, children wore an accelerometer on the non-dominant wrist (ActiGraph GT3X+) for 7 days and parents completed 2 × 24-hour time use diaries (TUDs) recording screen time and sleep on two separate days. For babies (i.e., not yet walking), parents completed 2 × 24-hour TUDs recording tummy time, active play, restrained time, screen time, and sleep on days 2 and 5 of the 7-day monitoring period. To assess test-retest reliability, parents were randomised to complete either the open- or closed-ended versions of the MBQ on day 7 and on day 10. Test-retest intraclass correlation coefficients (ICC's) were calculated using generalized linear mixed models and validity was assessed via Spearman correlations. RESULTS: Test-retest reliability for the MBQ-B was good to excellent with ICC's ranging from 0.80 to 0.94 and 0.71-0.93 for the open- and closed-ended versions, respectively. For both versions, significant positive correlations were observed between 24-hour diary and MBQ-B reported tummy time, active play, restrained time, screen time, and sleep (rho = 0.39-0.87). Test-retest reliability for the MBQ-C was moderate to excellent with ICC's ranging from 0.68 to 0.98 and 0.44-0.97 for the open- and closed-ended versions, respectively. For both the open- and closed-ended versions, significant positive correlations were observed between 24-hour diary and MBQ-C reported screen time and sleep (rho = 0.44-0.86); and between MBQ-C reported and device-measured time in total activity and energetic play (rho = 0.27-0.42). CONCLUSIONS: The MBQ-B and MBQ-C are valid and reliable rapid assessment tools for assessing 24-hour movement behaviours in infants, toddlers, and pre-schoolers. Both the open- and closed-ended versions of the MBQ are suitable for research conducted for policy and practice purposes, including the evaluation of scaled-up early obesity prevention programs.

Beyond brain injury: Examining the neuropsychological and psychosocial sequelae of post-traumatic epilepsy.

OBJECTIVE: This study investigates neuropsychological and psychosocial outcomes in patients with traumatic brain injury (TBI) and post-traumatic epilepsy (PTE) compared to a healthy control group. METHOD: Utilizing a quasi-experimental cross-sectional design, the research involved patients with TBI and PTE referred from a Taiwanese medical center. An age- and education-matched control group of healthy adults without traumatic injuries was also recruited. The study involved analyzing retrospective medical records and applying a comprehensive suite of neuropsychological tests and psychosocial questionnaires. RESULTS: Executive function measures revealed significantly reduced performance in both the TBI and PTE groups compared to controls. Specifically, the MoCA scores were lowest in the PTE group, followed by the TBI group, and highest in the controls. Measures of subjective symptomatology showed comparably elevated levels in both the TBI and PTE groups relative to controls. CONCLUSION: The research suggests that PTE may intensify the difficulties faced by individuals with TBI, but its impact on overall recovery might not be significant, considering the trajectory of the brain injury itself. Notably, the MoCA results indicate that cognitive deficits are more pronounced in PTE patients compared to those with TBI, underscoring the necessity for targeted neuropsychological assessments. Further investigation is essential to explore PTE's broader neuropsychological and psychosocial impacts. These findings advocate for tailored care strategies that address both neuropsychological and psychosocial needs, ensuring comprehensive management of TBI and PTE.

Inconsistencies in self-reported diabetes in a large panel study: the Survey of Health, Ageing and Retirement in Europe (SHARE).

BACKGROUND: The validity of self-reported chronic conditions has been assessed by comparing them with medical records or register data in several studies. However, the reliability of self-reports of chronic diseases has less often been examined. Our aim was to assess the proportion and determinants of inconsistent self-reports of diabetes in a long panel study. METHODS: SHARE (Survey of Health, Ageing and Retirement in Europe) includes 140,000 persons aged ≥ 50 years from 28 European countries and Israel. We used data from waves 1 to 7 (except wave 3) collected between 2004 and 2017. Diabetes was assessed by self-report. An inconsistent report for diabetes was defined as reporting the condition in one wave, but denying it in at least one later wave. The analysis data set included 13,179 persons who reported diabetes, and answered the question about diabetes in at least one later wave. Log-binomial regression models were fitted to estimate crude and adjusted relative risks (RR) with 95% confidence intervals (CI) for the associations between various exposure variables and inconsistent report of diabetes. RESULTS: The proportion of persons with inconsistent self-reports of diabetes was 33.0% (95% CI: 32.2%-33.8%). Inconsistencies occurred less often in persons taking antidiabetic drugs (RR = 0.53 (0.53-0.56)), persons with BMI ≥ 35 kg/m2 versus BMI < 25 kg/m2 (RR = 0.70, (0.64-0.77)), and poor versus excellent subjective health (RR = 0.87 (0.75-1.01)). Inconsistencies occurred more often in older persons (RR = 1.15 (1.12-1.18) per 10 years increase of age), and persons not reporting their age at diabetes onset (RR = 1.38 (1.31-1.45)). CONCLUSION: In SHARE, inconsistent self-report of diabetes is frequent. Consistent reports are more likely for persons whose characteristics make diabetes more salient, like intake of antidiabetic medication, obesity, and poor subjective health. However, lack of attention in answering the questions, and poor wording of the items may also play a role.

Response is increased using postal rather than electronic questionnaires - new results from an updated Cochrane Systematic Review.

BACKGROUND: A decade ago paper questionnaires were more common in epidemiology than those administered online, but increasing Internet access may have changed this. Researchers planning to use a self-administered questionnaire should know whether response rates to questionnaires administered electronically differ to those of questionnaires administered by post. We analysed trials included in a recently updated Cochrane Review to answer this question. METHODS: We exported data of randomised controlled trials included in three comparisons in the Cochrane Review that had evaluated hypotheses relevant to our research objective and imported them into Stata for a series of meta-analyses not conducted in the Cochrane review. We pooled odds ratios for response using random effects meta-analyses. We explored causes of heterogeneity among study results using subgroups. We assessed evidence for reporting bias using Harbord's modified test for small-study effects. RESULTS: Twenty-seven trials (66,118 participants) evaluated the effect on response of an electronic questionnaire compared with postal. Results were heterogeneous (I-squared = 98%). There was evidence for biased (greater) effect estimates in studies at high risk of bias; A synthesis of studies at low risk of bias indicates that response was increased (OR = 1.43; 95% CI 1.08-1.89) using postal questionnaires. Ten trials (39,523 participants) evaluated the effect of providing a choice of mode (postal or electronic) compared to an electronic questionnaire only. Response was increased with a choice of mode (OR = 1.63; 95% CI 1.18-2.26). Eight trials (20,909 participants) evaluated the effect of a choice of mode (electronic or postal) compared to a postal questionnaire only. There was no evidence for an effect on response of a choice of mode compared with postal only (OR = 0.94; 95% CI 0.86-1.02). CONCLUSIONS: Postal questionnaires should be used in preference to, or offered in addition to, electronic modes.

Examining Concordance Between Self-Report and Biomedical HIV Viral Load Data: A Scoping Review.

Assessment of HIV viral load based on laboratory results is the gold standard in HIV care and research. However, blood assay or accessing medical records is not always possible due to research or service contexts and constraints. Self-report of viral load test results expands data resources, is a convenient method of collecting data in both research and service settings, and is useful for HIV surveillance. The purpose of this scoping review was to identify existing literature on the validity of self-reported viral load data compared to blood assay or medical record review. We found that the existing literature is limited, with varied data collection methods, self-report measures, and study designs, as well as predictors of accuracy. Concordance between self-reported viral load and biomedical data varied across studies but appeared to be more consistent among samples recruited from clinical populations that reported engagement in HIV care. While it is difficult to draw definitive conclusions about the validity of self-reported viral load across existing studies, there is a need for a standardized measure and method of collection that can be utilized across diverse populations living with HIV.

RESUMEN: La evaluación de la carga viral del VIH basada en resultados de laboratorio es el patrón-oro en la atención e investigación del VIH. Sin embargo, el análisis de sangre o el acceso a los registros médicos no siempre es posible debido a los contextos y limitaciones de la investigación o los servicios. El autoinforme de los resultados de las pruebas de carga viral aumenta los recursos de datos, es un método conveniente de recopilación de datos tanto en contextos de investigación como de servicios, y es útil para la vigilancia de VIH. El propósito de esta revisión de alcance fue identificar la literatura existente sobre la validez de los datos de carga viral autoinformados en comparación con análisis de sangre o revisión de registros médicos. Encontramos que la literatura existente es limitada, con variados métodos de recopilación de datos, medidas de autoinforme y diseños de estudio, así como predictores de exactitud. La concordancia entre la carga viral autoinformada y los datos biomédicos varió entre los estudios, pero pareció ser más consistente entre las muestras reclutadas de poblaciones clínicas que indicaron participación en la atención del VIH. Aunque es difícil extraer conclusiones definitivas sobre la validez de la carga viral autoinformada en los estudios existentes, existe la necesidad de una medida y un método de recopilación estandarizados que puedan utilizarse en diversas poblaciones que viven con el VIH.

Validity and reliability of the Pain Assessment in Impaired Cognition 15 (PAIC15) observation scale in persons with aphasia.

BACKGROUND: The use of self-report pain scales in persons with aphasia can be challenging due to communication and cognitive problems, while for assessing pain self-report pain is considered the gold standard (Harrison RA, Field TS. Post stroke pain: identification, assessment, and therapy. Cerebrovasc Dis. 2015;39(3-4):190-201.). An observational scale may be used as an alternative. This study examines the validity and reliability of the observational Pain Assessment in Impaired Cognition (PAIC15) scale in persons with aphasia. METHODS: Persons with aphasia were observed during rest and transfer by two observers using the PAIC15. The PAIC15 comprises 15 items covering the three domains of facial expressions, body movements, and vocalizations. When able, the participant completed four self-report pain scales after each observation. The observations were repeated within one week. For criterion validity, correlations between the PAIC15 and self-report pain scales were calculated and for construct validity, three hypotheses were tested. Reliability was determined by assessing internal consistency, and intra- and interobserver agreement. RESULTS: PAIC15 observations were obtained for 71 persons (mean age 75.5 years) with aphasia. Fair positive correlations (rest: 0.35-0.50; transfer: 0.38-0.43) were reported between PAIC15 and almost all self-report pain scales. Results show that significantly more pain was observed in persons with aphasia during transfer than during rest. No differences were found for observed pain between persons with aphasia who use pain medication and those without, or persons who have joint diseases compared to those without. Results showed acceptable internal consistency. Intra- and interobserver agreement was high for most PAIC15 items, particularly for the domains body movements and vocalizations during rest and transfer. CONCLUSIONS: Recognition of pain in persons aphasia using the PAIC15 showed mixed yet promising results.

Overreporting of adherence to hepatitis C direct-acting antiviral therapy and sustained virologic response among people who inject drugs in the HERO study.

BACKGROUND: Self-reported adherence to direct-acting antivirals (DAAs) to treat hepatitis C virus (HCV) among persons who inject drugs (PWID) is often an overreport of objectively measured adherence. The association of such overreporting with sustained virologic response (SVR) is understudied. This study among PWID aimed to determine a threshold of overreporting adherence that optimally predicts lower SVR rates, and to explore correlates of the optimal overreporting threshold. METHODS: This study analyzed per-protocol data of participants with adherence data (N = 493) from the HERO (Hepatitis C Real Options) study. Self-reported and objective adherence to a 12-week DAA regimen were measured using visual analogue scales and electronic blister packs, respectively. The difference (Δ) between self-reported and objectively measured adherence was calculated. We used the Youden index based on receiver operating characteristic (ROC) curve analysis to identify an optimal threshold of overreporting for predicting lower SVR rates. Factors associated with the optimal threshold of overreporting were identified by comparing baseline characteristics between participants at/above versus those below the threshold. RESULTS: The self-reported, objective, and Δ adherence averages were 95.1% (SD = 8.9), 75.9% (SD = 16.3), and 19.2% (SD = 15.2), respectively. The ≥ 25% overreporting threshold was determined to be optimal. The SVR rate was lower for ≥ 25% vs. < 25% overreporting (86.7% vs. 95.8%, p <.001). The factors associated with ≥ 25% Δ adherence were unemployment; higher number of days and times/day of injecting drugs; higher proportion of positive urine drug screening for amphetamine, methamphetamine, and oxycodone, and negative urine screening for THC (tetrahydrocannabinol)/cannabis. CONCLUSIONS: Self-reported DAA adherence was significantly greater than objectively measured adherence among PWID by 19.2%. Having ≥ 25% overreported adherence was associated with optimal prediction of lower SVR rates. PWID with risk factors for high overreporting may need to be more intensively managed to promote actual adherence.

A Position Modification Device for the Prevention of Supine Sleep During Pregnancy: A Randomised Crossover Trial.

OBJECTIVE: To assess the effectiveness and acceptability of a pillow-like position modification device to reduce supine sleep during late pregnancy, and to determine the impacts on the severity of sleep-disordered breathing (SDB) and foetal well-being. DESIGN: Randomised cross-over study. SETTING AND POPULATION: Individuals in the third trimester of pregnancy receiving antenatal care at a tertiary maternity hospital in Australia. METHODS: Participants used their own pillow for a control week and an intervention pillow for a week overnight, in randomised order. Sleep position and total sleep time for each night of both weeks were objectively monitored, with a sleep study and foetal heart rate monitoring performed on the last night of each week. MAIN OUTCOME MEASURES: Primary outcome = percentage of sleep time in the supine position; secondary outcomes = apnoea-hypopnoea index, foetal heart rate decelerations and birthweight centile. RESULTS: Forty-one individuals were randomised with data collected on 35 participants over 469 nights. There was no difference in percentage of total sleep time in the supine position overnight between the control or intervention pillow week (13.0% [6.1, 25.5] vs. 16.0% [5.6, 27.2], p = 0.81 with a mean difference of 2.5% [95% CI] = -0.7, 5.6, p = 0.12), and no difference in the severity of SDB or foetal heart rate decelerations across weeks. However, increased supine sleep was significantly related to a higher apnoea-hypopnoea index (rs = 0.37, p = 0.003), lower birthweight (rs = -0.45, p = 0.007) and lower birthweight centile (rs = -0.45, p = 0.006). The proportion of supine sleep each night of the week varied widely both within and across participants, despite awareness of side-sleeping recommendations. CONCLUSIONS: We found no evidence to suggest that the adoption of a pillow designed to discourage supine sleep was effective in late pregnancy, with women spending an average of 1 h per night supine. Alternative devices should be investigated, incorporating lessons learnt from this study to inform trials of supine sleep minimisation in pregnancy. TRIAL REGISTRATION: Clinical Trial: (Australia New Zealand Clinical Trials Registry): ACTRN12620000371998.

Development and Testing of the Spinal Cord Injury Bladder and Bowel Control Questionnaire (SCI-BBC-Q).

INTRODUCTION: Recovery of lower urinary tract (LUT) and lower gastrointestinal tract (LGIT) is a high priority for people with lived experience following spinal cord injury (SCI). A universally accepted validated patient-reported outcome (PRO) measure of the individual sensory and motor components of LGIT and LUT function, which allows tracking of recovery is lacking. To address this literature gap, the SCI Bladder and Bowel Control Questionnaire (SCI-BBC-Q) was developed. METHODS: The SCI-BBC-Q was developed as a direct assessment of the micturition and defecation experiences of an individual with SCI with possible neurogenic LUT and LGIT dysfunction. The SCI-BBC-Q development process consisted of two phases, measure development and evaluation. Measure development was guided by a conceptual framework, review of existing instruments and literature, and an iterative process of item incorporation, review, feedback, and consensus revision. Evaluation included cognitive interviewing, and assessments of feasibility, reliability, and content validity. RESULTS: The final 6-item SCI-BBC-Q is a PRO, which assesses motor and sensory function related to micturition and defecation, requiring ~5 min to complete. Assessments of clarity of the instrument components with regard to understanding of what is being asked in the questionnaire, feasibility of administration, reliability, internal consistency, and agreement with proxy measures have demonstrated that the SCI-BBC-Q provides consistent, stable, and reproducible data. Significant correlations were found between SCI-BBC-Q scores and the anorectal motor and sensory components of the International Standards for the Neurological Classification of SCI. CONCLUSION: The SCI-BBC-Q is a practical and reliable method for baseline and ongoing evaluation of patients with neurogenic LUT and LGIT dysfunction, especially in the acute and subacute period when function is changing due to neurological plasticity. It is also appropriate for use in monitoring response to treatments related to neurological recovery.

Exploring older people's understanding of the QOL-ACC, a new preference-based quality-of-life measure, for quality assessment and economic evaluation in aged care: the impact of cognitive impairment and dementia.

BACKGROUND: Quality-of-life is an essential outcome for quality assessment and economic evaluation in health and social care. The-Quality-of-Life - Aged Care Consumers (QOL-ACC) is a new preference-based quality-of-life measure, psychometrically validated with older people in aged care. More evidence is needed to inform the self-report reliability of the QOL-ACC in older people with varying levels of cognitive impairment and dementia. METHODS: A think-aloud protocol was developed and applied with older residents. The Mini Mental State Examination (MMSE) was applied to assign participants to no cognitive impairment (NCI - MMSE score ≥ 27) and cognitive impairment (MMCI - MMSE score < 27) subgroups. Three independent raters utilised a Tourangeau survey response model-based framework to identify response issues. Data were compared across cognition subgroups and synthesized using a 'traffic light' grading to classify frequency and type of response issues. Gradings were utilised to assess self-report reliability according to different levels of cognitive impairment. RESULTS: Qualitative data from 44 participants (NCI = 20, MMCI = 24) were included for analysis. Response issues were more evident in the cognitive impairment subgroup than the no cognitive impairment subgroup. All participants who received a 'red' grade had an MMSE score of < 20 and 66% of 'amber' grades occurred in the cognitive impairment subgroup. CONCLUSIONS: The QOL-ACC is able to be completed reliably by older residents with an MMSE score > 17. Future research is needed to assess the generalisability of these findings to other preference-based quality of life instruments and for older people in other care settings including health systems.