Prospective validation of a seizure diary forecasting falls short.

OBJECTIVE: Recently, a deep learning artificial intelligence (AI) model forecasted seizure risk using retrospective seizure diaries with higher accuracy than random forecasts. The present study sought to prospectively evaluate the same algorithm. METHODS: We recruited a prospective cohort of 46 people with epilepsy; 25 completed sufficient data entry for analysis (median = 5 months). We used the same AI method as in our prior study. Group-level and individual-level Brier Skill Scores (BSSs) compared random forecasts and simple moving average forecasts to the AI. RESULTS: The AI had an area under the receiver operating characteristic curve of .82. At the group level, the AI outperformed random forecasting (BSS = .53). At the individual level, AI outperformed random in 28% of cases. At the group and individual level, the moving average outperformed the AI. If pre-enrollment (nonverified) diaries (with presumed underreporting) were included, the AI significantly outperformed both comparators. Surveys showed most did not mind poor-quality LOW-RISK or HIGH-RISK forecasts, yet 91% wanted access to these forecasts. SIGNIFICANCE: The previously developed AI forecasting tool did not outperform a very simple moving average forecasting in this prospective cohort, suggesting that the AI model should be replaced.

Physical impairment during and between migraine attacks: A daily diary study of patients with chronic migraine.

OBJECTIVE: While a substantial body of research describes the disabling impacts of migraine attacks, less research has described the impacts of migraine on physical functioning between migraine attacks. The objective of this study is to describe physical impairment during and between migraine attacks as a dimension of burden experienced by people living with chronic migraine. METHODS: The physical impairment domain of the Migraine Physical Function Impact Diary was recorded in headache diaries from the Medication Overuse Treatment Strategy trial. Days with moderate to severe headache were used to approximate migraine attacks. Factor analysis and regression analysis were used to describe associations between migraine and physical impairment. RESULTS: 77,662 headache diary entries from 720 participants were analyzed, including 25,414 days with moderate to severe headache, 19,149 days with mild headache, and 33,099 days with no headache. Mean physical impairment score was 41.5 (SD = 26.1) on days with moderate to severe headache, 12.8 (SD = 15.0) on days with mild headache, and 5.2 (SD = 13.1) on days with no headache. Physical impairment on days with mild headache and days with no headache was significantly associated with days since last moderate to severe headache, physical impairment with last moderate to severe headache, mild headache (compared to no headache), depression, hypersensitivities and cranial autonomic symptoms. CONCLUSIONS: Physical impairment occurs on migraine and non-migraine days. Study participants with frequent headaches, symptoms of depression, hypersensitivities and cranial autonomic symptoms experience physical impairment at a higher rate on days with no headache and days with mild headache.Clinical Trial Registration: ClinicalTrials.gov (NCT02764320).

Psychometric Evaluation of the Diary for Irritable Bowel Syndrome Symptoms-Constipation in a Prospective Observational Study.

OBJECTIVES: To evaluate the psychometric properties of the Diary for Irritable Bowel Syndrome Symptoms-Constipation (DIBSS-C), which was developed to support primary and secondary endpoints in irritable bowel syndrome (IBS) with predominant constipation (IBS-C) clinical trials. METHODS: Observational data were collected from 108 adults with IBS-C using a smartphone-type device for 17 days. DIBSS-C data regarding bowel movements (BMs) were collected for each event (along with the Bristol Stool Form Scale); abdominal symptoms were rated each evening. Global status items and the Gastrointestinal Symptom Rating Scale-IBS were completed on day 10 and day 17 and the IBS-Symptom Severity Scale on day 17. Item-level performance, internal consistency reliability, test-retest reliability, and construct validity were evaluated. RESULTS: The Abdominal Symptoms Domain score demonstrated high internal consistency reliability (Cronbach's alpha week 1 = 0.98; week 2 = 0.96) and test-retest reliability (intraclass correlation coefficient [ICC] = 0.93). Test-retest reliability was stronger for abdominal symptoms (ICC = 0.91-0.94) than for the frequency-based BM-related outcomes (ICC = 0.54-0.66). Key construct validity hypotheses were supported by moderate to strong correlations with the corresponding Gastrointestinal Symptom Rating Scale-IBS, IBS-Symptom Severity Scale, and Bristol Stool Form Scale items. All known-groups comparisons were statistically significant for the abdominal symptom items and domain score; evidence for known-groups validity of BM-related outcomes was supportive when based on constipation severity. CONCLUSIONS: The results of this study provided key psychometric evidence for the DIBSS-C, ultimately contributing to its qualification by the US Food and Drug Administration for use in IBS-C clinical trials.

A Qualitative Study to Explore the Nurses' Experience of Writing Caring Notes in Diaries for Extracorporeal Oxygenation Membrane (ECMO) Patients: Explore the nurse's experience.

The use of diaries is known to reduce post-intensive care syndrome in the intensive care unit (ICU) for survivors and families. Studies are needed to explore nurses' experience with diaries. Although the diaries are written for the patient, the diary entries may be helpful for the nurse as well. Research has shown that ICU diaries fill in significant memory gaps and aid in the resolution of delusional memories. However, there is a shortage of knowledge about the nurses' experience of writing caring notes in diaries. The purpose of this research was to explore the extracorporeal membrane oxygenation (ECMO) nurses' experience of writing caring notes in diaries during the patients' ICU stay. This is a descriptive phenomenological qualitative research study using semi-structured interviews. A one-on-one interview was performed, audiotaped, and transcribed. Three investigators analyzed the data for themes, subcategories, and indicators. A purposive sample of 15 specialty-trained ECMO nurses participated in the study. Three themes emerged from the study relating to the nurse, family, and patient, including positive and negative aspects of writing in the diary and barriers. The vast majority (88%) of 340 comments answered during the interviews were positive. Overall, nurses found the diaries to be beneficial to the nurse, family, and patient. Diary writing may help nurses get back to the core of why we do what they do. Understanding the nurses' experience may help to improve communication and family satisfaction while optimizing dairy programs.

A Daily Diary Study of the Relation between Stress and Nonsuicidal Self-Injury and the Moderating Role of Emotion Dysregulation in Emerging Adulthood.

Research on exposure to stressors and nonsuicidal self-injury (NSSI) in daily life has been lacking, particularly among emerging adults (aged 18-25 years). The aim of this study was to determine whether daily stressors predicted same-day and next-day NSSI thoughts and engagement, and whether emotion dysregulation moderated this relation. Participants included 160 emerging adults (83% female, Mage = 19.75, SD = 1.8, 44% White, 22% East Asian, 11% South Asian, and 23% other) who completed a baseline assessment and 14 days of daily diary entries which resulted in 1982 daily assessments (median compliance = 86%; IQR = 12-14). It was found that daily stressors significantly predicted same-day, but not next-day, NSSI thoughts and engagement and this relation was more pronounced for individuals with greater emotion dysregulation. The present study provides new insight into when individuals may be most at risk for NSSI, as well as which individuals may be most vulnerable.

Family's preferences for and experiences of writing practices in adult intensive care and its use in early bereavement: A descriptive qualitative study.

BACKGROUND: Family partaking in writing practices, such as writing intensive care unit (ICU) patient diaries, personal diaries/journaling, social media, or instant messaging services, during ICU admission may allow the family to unintentionally participate in a form of expressive writing. These writing practices could provide structure for the family authors to explore emotions and manage significant life events, including death of a loved one. Limited studies have explored the family's postmortem experiences and perceived value of writing practices maintained during an ICU admission. OBJECTIVES: The objective of this study was to explore the family member's preferences for and experiences of writing practices in the adult ICU and its use in early bereavement. METHODS: descriptive qualitative design using inductive reflexive thematic analysis from a purposeful, convenience sample of 16 bereaved participants from a tertiary referral, adult ICU in Australia who discussed their experiences of and preferences in writing practices. Reporting adheres to the consolidated criteria for reporting qualitative research checklist. FINDINGS: Six participants maintained writing practices during the ICU admission and 10 did not. Three themes were generated from the data: the decision to maintain writing practices was shaped by past behaviours and perceived utility; moments captured were influenced by the loved ones' clinical status and their ability to access the writing medium; and writing practices have limited utility as a memory making object in early bereavement. CONCLUSIONS: Based on the generated findings, participants who did not maintain writing practices did not later regret this decision during early bereavement. Participants who did maintain writing practices predominately used a personal diary/journal that they carried with them. As the loved one approached death, the written entries became shorter, then ceased. Most of the written entries were not read during early bereavement, suggesting the writing practices' psychological value might have been predominately gained at the time of writing, rather than during early bereavement.

The feasibility of daily monitoring in adolescents and young adults with mild intellectual disability or borderline intellectual functioning.

BACKGROUND: It is unclear whether the limitations of young persons with a mild intellectual disability or borderline intellectual functioning preclude feasibility of the daily diary method. METHOD: For 60 consecutive days, 50 participants (Mage = 21.4, 56% male) who receive care in an ambulatory, residential, or juvenile detention setting, self-rated both standardised and personalised diary questions through an app. Diary entries were used for feedback in treatment. Interviews were used to explore acceptability. RESULTS: Average compliance was 70.4%, while 26% of participants dropped out. Compliance was good in ambulatory (88.9%) and residential care (75.6%), but not in the juvenile detention setting (19.4%). The content of self-selected diary items varied widely. Participants deemed the method acceptable. CONCLUSIONS: Daily monitoring is feasible for individuals with a mild intellectual disability or borderline intellectual functioning receiving ambulatory or residential care, and can provide scientists and practitioners with important insights into day-to-day behavioural patterns.

Exploring Patients' Perceptions on ICU Diaries: A Systematic Review and Qualitative Data Synthesis.

OBJECTIVES: This study aims to summarize the current qualitative evidence on patients' experiences of reading the ICU diaries. DATA SOURCES: We searched the online databases PubMed, Ovid, EMBASE, and EBSCO host from inception to July 2020. STUDY SELECTION: All studies that presented any qualitative findings regarding patients' experiences of reading an ICU diary were included. DATA EXTRACTION: Study design, location, publication year, data collection method, and mode, all qualitative themes identified and reported, and participant quotations, when appropriate. We also extracted data regarding the diary structure, when available. A thematic synthesis approach was used to analyze and synthesize qualitative data. DATA SYNTHESIS: Seventeen studies were analyzed. Most patients reported positive experiences with the ICU diary, such as understanding what they survived during critical illness, better understanding the process of recovery, gaining coherence of nightmares and delusional memories, realizing the importance of the presence of family and loved ones during ICU stay, and humanizing healthcare professionals that helped them survive critical illness. Patients also reported which components of the diary were important for their recovery, such as the presence of photographs and reading the diary with a healthcare professional, allowing the improvement of the concept of the ICU diary. CONCLUSION: This qualitative synthesis shows that patients recommend having an ICU diary, enlightening benefits such as better coping with the slow recovery from critical illness, strengthening family ties, and humanizing the ICU staff. It also identifies characteristics of the diary valued by the patients, in order to standardize the ICU diary according to their perspectives, and allowing future comparability between randomized controlled trials.

The Cycle of Daily Stress and Sleep: Sleep Measurement Matters.

BACKGROUND: Disturbed sleep can be a cause and a consequence of elevated stress. Yet intensive longitudinal studies have revealed that sleep assessed via diaries and actigraphy is inconsistently associated with daily stress. PURPOSE: We expanded this research by examining daily associations between sleep and stress using a threefold approach to assess sleep: sleep diaries, actigraphy, and ambulatory single-channel electroencephalography (EEG). METHODS: Participants were 80 adults (mean age = 32.65 years, 63% female) who completed 7 days of stressor and sleep assessments. Multilevel models were used to examine bidirectional associations between occurrence and severity of daily stress with diary-, actigraphy-, and EEG-determined sleep parameters (e.g., total sleep time [TST], sleep efficiency, and sleep onset latency, and wake after sleep onset [WASO]). RESULTS: Participants reported at least one stressor 37% of days. Days with a stressor were associated with a 14.4-min reduction in actigraphy-determined TST (ß = -0.24, p = 0.030), but not with other actigraphy, diary, or EEG sleep measures. Nights with greater sleep diary-determined WASO were associated with greater next-day stressor severity (ß = 0.01, p = 0.026); no other diary, actigraphy, or EEG sleep measures were associated with next-day stressor occurrence or severity. CONCLUSIONS: Daily stress and sleep disturbances occurred in a bidirectional fashion, though specific results varied by sleep measurement technique and sleep parameter. Together, our results highlight that the type of sleep measurement matters for examining associations with daily stress. We urge future researchers to treat sleep diaries, actigraphy, and EEG as complementary-not redundant-sleep measurement approaches.

Mean Levels and Variability in Psychological Well-Being and Associations With Sleep in Midlife and Older Women.

BACKGROUND: Disturbed sleep is prevalent in older adulthood and particularly among women. Greater psychological well-being (PWB) is associated with better sleep, but intraindividual variability in PWB has not been examined. PURPOSE: The current study examined whether mean levels and variability in PWB were associated with sleep disturbances in midlife and older women. METHODS: Participants (N = 189) completed up to seven daily diaries and an end of the week assessment every 3 months for nine waves. Participants answered questions about their nightly sleep disturbances and reported their PWB using Ryff's six dimensions of PWB. RESULTS: Regression models indicated that greater variability in one aspect of PWB, positive relations with others, was related to greater sleep disturbance even after adjusting for mean levels of well-being. Greater variability in environmental mastery, purpose in life, and self-acceptance were also associated with sleep disturbance, but these associations were no longer significant after adjusting for mean levels of well-being. CONCLUSIONS: Results suggest that fluctuations in positive relations with others are related to sleep in adult women above and beyond mean levels of well-being. Results highlight the importance of considering variability in addition to mean levels of PWB.

Development and Validation of the Parenting Skill Use Diary (PSUD) in a Nationally Representative Sample.

Objective: We describe the development and psychometric properties of an instrument designed to assess the use of effective parenting skills reported with a daily diary. The Parenting Skill Use Diary (PSUD) was developed iteratively relying on a "common elements" approach to quantify the use of evidence-based parenting techniques for responding to child misbehaviors and positive behaviors.Method: The PSUD was administered online daily for seven days to parents/guardians of children aged 5-12. The nationally representative sample (N = 1,570) was selected to match the US population of such parents/guardians on key demographic variables.Results: The instrument demonstrated the ability to capture significant between person variability in the appropriate use of parent management skills. A weekly summary score discriminated between parents/guardians whose children screened positive versus negative for Conduct Disorder (AUC = .72) and Oppositional Defiant Disorder (AUC = .70).Conclusions: The results supported the reliability of validity of the diary as a research tool for examining mean differences.

[Investigation of the reproducibility and validity of a questionnaire on usual bowel movement patterns and stool characteristics compared to an evacuation diary].

Objective　Stool reflect our dietary and nutritional status as well as the characteristics of gut microbiota; thus, stool can be a convenient, noninvasive index for the evaluation of physical health and nutritional intake. However, there are few studies on appropriate tools for comprehensive and easy-to-perform objective assessments of stool. Therefore, there is a need for an effective questionnaire to accurately ascertain daily bowel movement patterns ("usual evacuation") and stool characteristics. Herein, we have created an assessment tool to determine stool characteristics (volume, color, form, etc.). To investigate the validity of this tool, we compared the results with evacuation diary data wherein the participants were asked to record the number of evacuations and stool characteristics.Methods　This study included 35 adult men and women, aged 22-78 years (45.2±17.1years). A questionnaire was administered to the subjects on usual stool characteristics for the most recent month, including the average number of evacuations, stool volume per evacuation, stool color and form, stool float, and abdominal bloating. To confirm the reproducibility of each item of this questionnaire, the survey was performed twice. Thereafter, an evacuation diary was used, wherein the subjects recorded the daily number of evacuations and stool characteristics for one week. Using the evacuation diary as the valid criterion for the number of evacuations and stool characteristics, we compared responses between the diary and the usual stool questionnaire. Additionally, the questionnaire had two types of responses for the number of evacuations, namely, multiple choice for categories indicating the number of evacuations and open answers using numerical values.Results　Assessment of the reproducibility of the questionnaire on usual stool by Spearman rank correlation coefficients showed a significant correlation (ρ=0.431-0.911) for all items. The weighted κ coefficient also showed high coincidence (weighted κ=0.348-0.841). Validity was assessed by comparing the number of evacuations per one-week period between the evacuation diary and the usual stool questionnaire. A higher correlation (ρ=0.855) was observed in the open responses for the number of evacuations per one-week period. Assessment of the correlations between median values for responses to stool characteristics in the one-week evacuation diary and the usual stool questionnaire showed significant correlation (ρ=0.429-0.800) for all items except for "stool float".Conclusion　We confirmed the high reproducibility and validity of the questionnaire created in this study for the assessment of usual bowel movement patterns and stool characteristics.

Can men with lower urinary tract symptoms (LUTs) predict voided volumes?

PURPOSE: To determine if patients can accurately estimate volumes voided in a bladder diary, and to determine the patient characteristics that are most predictive of accuracy in volume estimation in the workup of lower urinary tract symptoms (LUTs). METHODS: We prospectively collected data on 180 consecutive patients undergoing a workup for LUTs at a tertiary care facility. Data collected include American Urological Association Symptom Scores (AUASS), flow time and rate, and one time measurement of voided volume into a blinded uroflow. Baseline characteristics and demographics were recorded. Descriptive statistics and linear regression analysis were performed to examine predictors of estimated voiding volume (mL) in SAS Version 9.4 (SAS Institute, Inc., Cary, NC, USA). RESULTS: Median age and BMI were 64 years (SD = 15.4) and 26.9 kg/m2 (SD = 4.6), respectively. The median estimated voided volume and actual voided volume were 120 mL (range 1-480) and 101.5 mL (range 6.5-622.0), respectively. On linear regression analysis, 47.1% of patients estimated volume voided with a 20% margin of error, and 63.2% of patients estimated with a 30% margin of error. Each 1-year increase in age correlated with a 2% decrease in the odds of estimating voided volume within 20% of actual volume (p < 0.05). For each 1 unit increase in flow rate, there was an 8% (p < 0.005) increase in the odds of estimating voided volume within 20% of actual volume. CONCLUSIONS: Just under half of patients can accurately estimate volume voided with a margin of error of 20%.

Nurse-Guided Internet-Delivered Cognitive Behavioral Therapy for Insomnia in General Practice: Results from a Pragmatic Randomized Clinical Trial.

INTRODUCTION: Guidelines recommend cognitive behavioral therapy for insomnia (CBT-I) as the first line of treatment for insomnia in general practice, but CBT-I is rarely available. Nurse-guided Internet-delivered CBT-I might be a solution to improve access to care. OBJECTIVE: We aimed to determine the effectiveness of nurse-guided Internet-delivered CBT-I (I-CBT-I) on insomnia severity experienced by patients in general practice. METHODS: Nurse-guided I-CBT-I ("i-Sleep") was compared to care-as-usual (and I-CBT-I after 6 months) in 15 participating general practices among 134 patients (≥18 years old) with clinical insomnia symptoms. Assessments took place at 8, 26 and 52 weeks. Primary outcome was self-reported insomnia severity (Insomnia Severity Index) at 8 weeks. Secondary outcomes were sleep diary indices, depression and anxiety symptoms (Hospital Anxiety and Depression Scale), fatigue, daytime consequences of insomnia, sleep medication and adverse events. RESULTS: Two thirds of the 69 intervention patients (n = 47; 68%) completed the whole intervention. At the posttest examination, there were large significant effects for insomnia severity (Cohen's d =1.66), several sleep diary variables (wake after sleep onset, number of awakenings, terminal wakefulness, sleep efficiency, sleep quality) and depression. At 26 weeks there were still significant effects on insomnia severity (d = 1.02) and on total sleep time and sleep efficiency. No significant effects were observed for anxiety, fatigue, daily functioning or sleep medication. No adverse events were reported. CONCLUSIONS: Nurse-guided I-CBT-I effectively reduces insomnia severity among general practice patients. I-CBT-I enables general practitioners to offer effective insomnia care in accordance with the clinical guidelines.

Development and Internal Validation of a Multivariable Prediction Model for Individual Episodic Migraine Attacks Based on Daily Trigger Exposures.

OBJECTIVE: To develop and internally validate a multivariable predictive model for days with new-onset migraine headaches based on patient self-prediction and exposure to common trigger factors. BACKGROUND: Accurate real-time forecasting of one's daily risk of migraine attack could help episodic migraine patients to target preventive medications for susceptible time periods and help decrease the burden of disease. Little is known about the predictive utility of common migraine trigger factors. METHODS: We recruited adults with episodic migraine through online forums to participate in a 90-day prospective daily-diary cohort study conducted through a custom research application for iPhone. Every evening, participants answered questions about migraine occurrence and potential predictors including stress, sleep, caffeine and alcohol consumption, menstruation, and self-prediction. We developed and estimated multivariable multilevel logistic regression models for the risk of a new-onset migraine day vs a healthy day and internally validated the models using repeated cross-validation. RESULTS: We had 178 participants complete the study and qualify for the primary analysis which included 1870 migraine events. We found that a decrease in caffeine consumption, higher self-predicted probability of headache, a higher level of stress, and times within 2 days of the onset of menstruation were positively associated with next-day migraine risk. The multivariable model predicted migraine risk only slightly better than chance (within-person C-statistic: 0.56, 95% CI: 0.54, 0.58). CONCLUSIONS: In this study, episodic migraine attacks were not predictable based on self-prediction or on self-reported exposure to common trigger factors. Improvements in accuracy and breadth of data collection are needed to build clinically useful migraine prediction models.

Wear-Off of OnabotulinumtoxinA Effect Over the Treatment Interval in Chronic Migraine: A Retrospective Chart Review With Analysis of Headache Diaries.

OBJECTIVE: To quantify wear-off of the response to OnabotulinumtoxinA (OnabotA) treatment over the treatment cycle in chronic migraine at group and individual level. BACKGROUND: OnabotA administered quarterly is an effective treatment for chronic migraine. However, some patients report that headache recurs before the scheduled follow-up injection. METHODS: In this retrospective chart review performed in 6 university outpatient centers or private practices specialized in headache treatment, 112 patients with a ≥30% response to OnabotA who completed headache diaries over 13 weeks after OnabotA treatment were included (age [mean ± SD] 45 ± 12 years, 82% female, headache days/month at baseline 24 ± 6). RESULTS: Compared to weeks 5 to 8 after injection, headache days/week increased significantly in weeks 12 (+0.52 ± 1.96, 95% CI [0.15, 0.88], P < .009) and 13 (+1.15 ± 1.95, CI[0.79, 1.52], P < .001), demonstrating significant wear-off of the OnabotA effect. Similarly, acute medication days/week significantly increased in weeks 12 (0.38±1.67, CI [0.06, 0.69], P ≤ .027) and 13 (+0.83 ± 1.76, CI [0.49, 1.16], P < .001). At an individual level, 57 patients (51%) showed ≥30% wear-off by weeks 12 and 13, and 28 patients (25%) showed ≥30% wear-off already by weeks 10 and 11. Age, gender, OnabotA dose or cycle number, or headache center did not predict individual wear-off. CONCLUSIONS: These data show that in clinical practice, on average the response of chronic migraine patients to OnabotA injection shows a clinically significant wear-off from week 12 after treatment. About 25% of the patients experience wear-off even by weeks 10 and 11. It must be noted that wear-off detected in a real-world study on OnabotA responders can be due to wear-off of a pharmacological OnabotA effect or a placebo effect, or to regression to the mean effects. This wear-off phenomenon may negatively affect quality of life of chronic migraine patients under OnabotA treatment. The best way to counteract wear-off remains to be determined.

Effect of an ICU diary on psychiatric disorders, quality of life, and sleep quality among adult cardiac surgical ICU survivors: a randomized controlled trial.

BACKGROUND: Although studies on the effectiveness of the use of ICU diaries on psychiatric disorders and quality of life have been published, the results still seem to be controversial. The study aimed to determine the effects of using an ICU diary on psychiatric disorders, sleep quality, and quality of life (QoL) in adult ICU survivors in China. METHODS: One hundred and twenty-six patients who underwent a scheduled cardiac surgery and were expected to stay ≥ 24 h in ICU were randomized to two groups (63 in each group). The patients in the intervention group received the use of ICU diaries during the period of post-ICU follow-up, while the patients in the control group received usual care without ICU diaries. The primary outcome was significant PTSD symptoms (Chinese version of Impact of Event Scale-Revised, IES-R; total score ≥ 35 was defined as significant PTSD symptoms) and its severity in patients 3 months post-ICU. The secondary outcomes included memories of the ICU at 1 month, QoL (Medical Outcomes Study 36-item Short-Form, SF-36), sleep quality (Pittsburgh Sleep Quality Index Questionnaire, PSQI), anxiety, and depression symptoms (Hospital Anxiety and Depression Scale, HADS) at 3 months. RESULTS: Eighty-five and 83 patients completed the follow-up interviews at 1 month and 3 months post-ICU, respectively. Significant PTSD symptoms were reported by 6 of 41 (14.63%) in the intervention group vs 9 of 42 (21.43%) in the control group (risk difference, - 9% [95% CI, - 2% to 21%], P = 0.10). There was no significant differences between groups in IES-R score, symptoms of intrusion, symptoms of avoidance, numbers of memories of feeling and delusional memories, SF-36 score and anxiety score (P > 0.05), while significant differences were found in symptom of hyperarousal score, numbers of factual memories and PSQI score (P < 0.05). No adverse effect was reported. CONCLUSIONS: Using an ICU diary is not useful for preventing PTSD symptoms and anxiety symptoms and preserving the quality of life of the patients at 3 months post-ICU, while it significantly improves the survivor's factual memory of ICU and sleep quality, and prevents the hyperarousal symptom. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR-IOR-16009109, registered on 28 August 2016.

Mobile e-diary application facilitates the monitoring of patient-reported outcomes and a high treatment adherence for clinical trials in dermatology.

BACKGROUND: Assessment of treatment effects in clinical trials requires valid information on treatment adherence, adverse events and symptoms. Paper-based diaries are often inconvenient and have limited reliability, particularly for outpatient trials. OBJECTIVES: To investigate the utility of an electronic diary (e-diary) application for patients with skin diseases in outpatient clinical trials. METHODS: An e-diary application was developed and technically validated. Treatment adherence was defined as topical administration by the patient, and patient-reported outcomes, i.e. pain and itch, were evaluated by the e-diary in six clinical trials on newly tested topical drugs. Additionally, the proportion of patients capturing the applied topical drug by camera and filling in the pain and itch scores was defined as e-diary adherence, and patients' perception of usefulness and acceptability of the e-diary were evaluated. RESULTS: Treatment adherence rates of the included 256 patients were high (median 98%, range 97-99%). E-diary adherence was also high with a median of 93% (range 87-97%) for capturing the applied drug by camera, and 89% (range 87-96%) and 94% (range 87-96%) for entering respectively the itch and pain score. Daily symptom scores provided good insights into the disease burden, and patients rated the e-diary as good to excellent with respect to user acceptability. CONCLUSIONS: The results suggest that the e-diary is an excellent way to ensure proper treatment administration, indicated by both the high user acceptability scores and high treatment adherence. Moreover, the e-diary may also be valuable for frequent and reliable monitoring of patient-reported outcomes in daily clinical practice.

Involuntary autobiographical memories and future projections in social anxiety.

Intrusive involuntary memories and images are a cardinal phenomenon in a range of psychological disorders, but not systematically examined in social anxiety. We examined potential biases upon generating involuntary versus voluntary memories and future projections in individuals with high and low levels of social anxiety. Participants recorded involuntary and voluntary autobiographical events, and their associated emotional response in a structured mental time travel diary. High social anxiety was associated with more intense anxiety and embarrassment and greater use of a range of emotion regulation strategies upon generating all types of autobiographical events. Involuntary (versus voluntary) memories and future events were associated with a heightened emotional response independent of social anxiety, and memories were associated with more embarrassment than imagined future events. The effects of high versus low social anxiety and involuntary versus voluntary generation process were independent from each other. The findings have implications for affective and cognitive models of involuntary memories and future projections in emotional disorders.

Prospective memory errors in everyday life: does instruction matter?

Previous research on prospective memory (PM, the ability to remember executing an intention in the future) suggests that PM errors constitute the majority of all everyday memory errors in younger adults. However, no study so far has investigated this ratio from an ageing perspective, nor examined whether different instructions may influence PM error reporting. In the present study, 64 younger and 64 older adults completed a 5-day diary on PM, memory and cognition errors following different reporting instructions: participants had to either focus on (1) PM errors only, (2) any daily memory errors (prospective or retrospective) or (3) any kind of cognitive error. Error descriptions were coded into subcategories and analysed both quantitatively and qualitatively. Independently of given instructions, PM was the most frequent everyday error for both age groups. Overall, results confirm age differences for everyday PM (but not for retrospective memory and cognition), suggesting that everyday PM might be spared from age-related decline. From a qualitative point of view, there seem to be differences in the type of missed intentions, which correspond with existent theories of ageing. In conclusion, the present study allowed for a deeper insight into everyday PM functioning in younger and older adults.