Development of standard computerised adaptive test (CAT) settings for the EORTC CAT Core.

AIMS: Computerised adaptive test (CAT) provides individualised patient reported outcome measurement while retaining direct comparability of scores across patients and studies. Optimal CAT measurement requires an appropriate CAT-setting, the set of criteria defining the CAT including start item, item selection criterion, and stop criterion. The European Organisation for Research and Treatment of Cancer (EORTC) CAT Core allows for assessing the 14 functional and symptom domains covered by the EORTC QLQ-C30 questionnaire. The aim was to present a general approach for selecting CAT-settings and to use this to develop a portfolio of standard settings for the EORTC CAT Core optimised for different purposes and populations. METHODS: Using simulations, the measurement properties of CATs of different length and precision were evaluated and compared allowing for identifying the most suitable settings. All CATs were initiated with the most informative QLQ-C30 item. For each domain two fixed-length and two fixed-precision standard CATs were selected focusing on efficiency (brief version) and precision (long), respectively. RESULTS: The brief fixed-length CATs included 3-5 items each while the long versions included 5-8 items. The fixed-precision CATs aimed for reliability of 0.65-0.95 (brief versions) and 0.85-0.98 (long versions), respectively. Median sample size savings using the CATs compared to the QLQ-C30 scales ranged 20%-31%, although savings varied considerably across the domains. CONCLUSION: The EORTC CAT Core standard settings simplify selection of relevant and appropriate CATs. The CATs prioritise either brevity and efficiency or precision, but all provide increased measurement precision and hence, reduced sample size requirements compared to the QLQ-C30 scales. The CATs may be used as they are or modified to accommodate specific requirements.

Development of a diverse set of standard short forms based on the EORTC CAT Core item banks.

PURPOSE: The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group has developed item banks covering the 14 domains of the EORTC QLQ-C30 quality of life questionnaire. These allow for dynamic assessment and for forming population/study specific static short forms. To simplify selection of relevant short forms, we here present a portfolio of standard short forms with measurement properties optimized for different populations. METHODS: For each domain, a brief and a long version were constructed for each of three populations having mild, moderate, and severe symptoms, respectively. The most informative items were prioritised while also taking content into consideration. All short forms included at least one QLQ-C30 item. The measurement precision/power of the short forms was compared to the corresponding QLQ-C30 scales using simulations. RESULTS: In total, 84 short forms were constructed. The brief versions included 3-5 items each, the long versions 5-9 items. Estimated sample size savings using the suggested short forms while maintaining the same power as with the QLQ-C30 ranged 3-50% across domains with median savings of 19% (brief versions) and 28% (long versions), respectively. CONCLUSION: The suggested short forms allow for simple selection of items particularly relevant for patients with mild, moderate, or severe symptoms, respectively. They facilitate the use of smaller samples without loss of power compared to the QLQ-C30 scales. The suggested short forms may be used as they are or adapted to the specific aims of individual studies/settings.

A mixed-method investigation into measurement reactivity to the experience sampling method: The role of sampling protocol and individual characteristics.

Since the introduction of the experience sampling method (ESM), there have been concerns that the repeated assessments typically related to this method may alter the behavior, thoughts, or feelings of participants. Previous studies have offered mixed results with some studies reporting reactive changes, while others failed to find such effects. Our aim was to investigate under which circumstances ESM induces reactive effects. Students (N = 151) were randomly assigned to receive a questionnaire containing 30 or 60 items three, six, or nine times per day for 14 days. A random sample of 50 participants took part in qualitative interviews after the end of the data collection. We investigated changes over time in the data, while taking into account the sampling protocol and characteristics of participants, and analyzed qualitative reports of measurement reactivity. Decreases in completion time, within-person variance of ratings and subjective reports of habituation point toward the existence of a habituation period. While participants reported increases in emotional awareness in interviews, ESM measures indicated a decrease in emotional awareness over time. Changes in behavior were rare in quantitative and qualitative reports. Positive affect was decreasing over time in the ESM data, and various changes in affect, emotion regulation, and thoughts were reported in interviews. Individual characteristics and sampling protocol had inconsistent effects on changes over time. The results suggest that ESM induces changes in within-person variability, completion times, affect, or emotional awareness over time. Further research is needed to explore whether observed changes affect the validity of ESM data. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

A randomised pilot trial of virtual reality-based relaxation for enhancement of perioperative well-being, mood and quality of life.

A cancer diagnosis and subsequent treatment can trigger distress, negatively impact coping resources, and affect well-being as well as quality of life. The aim of this pilot study was to investigate feasibility and clinical effects of a VR intervention on quality of life, well-being and mood in cancer patients undergoing surgery compared to a non-VR intervention and a control group. 54 patients with colorectal cancer or liver metastases from colorectal cancer undergoing elective curatively intended surgery were recruited and randomised to one of two intervention groups or a control group receiving standard treatment. Participants assigned to one of the intervention groups either received a VR-based intervention twice daily or listened to music twice daily. Adherence to the intervention was 64.6% in the music group and 81.6% in the VR group. The VR intervention significantly reduced heart rate (- 1.2 bpm; 95% CI - 2.24 to - 0.22; p = 0.02) and respiratory rate (- 0.7 brpm; 95% CI - 1.08 to - 0.25; p = 0.01). Self-reported overall mood improved in both groups (VR: + 0.79 pts; 95% CI 0.37-1.21; p = 0.001; music: + 0.59 pts; 95% CI 0.22-0.97; p = 0.004). There was no difference in quality of life between the three groups. Both interventions groups reported changes in feelings. Adherence rates favoured the VR intervention over the music group. Observed clinical outcomes showed stronger intragroup effects on mood, feelings, and vital signs in the VR group. The study demonstrated feasibility of a VR intervention in cancer patients undergoing surgery and should encourage further research investigating the potential of VR interventions to positively influence well-being and mood in cancer patients.

The Effects of Sampling Frequency and Questionnaire Length on Perceived Burden, Compliance, and Careless Responding in Experience Sampling Data in a Student Population.

Currently, little is known about the association between assessment intensity, burden, data quantity, and data quality in experience sampling method (ESM) studies. Researchers therefore have insufficient information to make informed decisions about the design of their ESM study. Our aim was to investigate the effects of different sampling frequencies and questionnaire lengths on burden, compliance, and careless responding. Students (n = 163) received either a 30- or 60-item questionnaire three, six, or nine times per day for 14 days. Preregistered multilevel regression analyses and analyses of variance were used to analyze the effect of design condition on momentary outcomes, changes in those outcomes over time, and retrospective outcomes. Our findings offer support for increased burden and compromised data quantity and quality with longer questionnaires, but not with increased sampling frequency. We therefore advise against the use of long ESM questionnaires, while high-sampling frequencies do not seem to be associated with negative consequences.

Virtual reality-based relaxation for enhancement of perioperative well-being and quality of life: protocol for a randomised pilot trial.

INTRODUCTION: Patients with cancer undergoing surgery often suffer from reduced quality of life and various forms of distress. Untreated distress can negatively affect coping resources as well as surgical and oncological outcomes. A virtual reality-based stress reduction intervention may increase quality of life and well-being and reduce distress in the perioperative phase for patients with cancer. This pilot trial aims to explore the feasibility of the proposed intervention, assess patient acceptability and obtain estimates of effect to provide data for sample size calculations. METHODS AND ANALYSIS: Patients with colorectal cancer and liver metastasis undergoing elective surgery will be recruited for this single-centre, randomised pilot trial with a three-arm design. A total of 54 participants will be randomised at 1:1:1 ratio to one of two intervention groups or a control receiving standard treatment. Those randomised to an intervention group will either receive perioperative virtual reality-based stress reduction exercises twice daily or listen to classical music twice daily. Primary feasibility outcomes are number and proportions of participants recruited, screened, consented and randomised. Furthermore, adherence to the intervention, compliance with the completion of the quality of life questionnaires and feasibility of implementing the trial procedures will be assessed. Secondary clinical outcomes are measurements of the effectiveness of the interventions to inform sample size calculations. ETHICS AND DISSEMINATION: The study protocol, the patient information and the informed consent form have been approved by the ethics committee of the Ludwigs-Maximilians-University, Munich, Germany (Reference Number: 19-915). Study findings will be submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: DRKS00020909.

Reported Affect Changes as a Function of Response Delay: Findings From a Pooled Dataset of Nine Experience Sampling Studies.

Delayed responses are a common phenomenon in experience sampling studies. Yet no consensus exists on whether they should be excluded from the analysis or what the threshold for exclusion should be. Delayed responses could introduce bias, but previous investigations of systematic differences between delayed and timely responses have offered unclear results. To investigate differences as a function of delay, we conducted secondary analyses of nine paper and pencil based experience sampling studies including 1,528 individuals with different clinical statuses. In all participants, there were significant decreases in positive and increases in negative affect as a function of delay. In addition, delayed answers of participants without depression showed higher within-person variability and an initial strengthening in the relationships between contextual stress and affect. Participants with depression mostly showed the opposite pattern. Delayed responses seem qualitatively different from timely responses. Further research is needed to understand the mechanisms underlying these differences.

Reference values for the EORTC QLQ-C30 in patients with advanced stage Hodgkin lymphoma and in Hodgkin lymphoma survivors.

OBJECTIVES: To provide reference values for the European Organisation for Treatment and Research of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) in advanced-stage Hodgkin lymphoma (HL) patients and 5-year HL survivors. The QLQ-C30 is the most widely used cancer-specific questionnaire to assess Health-Related Quality of Life (HRQoL). METHODS: The EORTC database was searched to identify HL RCTs in which patients' and survivors' HRQoL was assessed by the QLQ-C30. HRQoL mean scores were calculated and stratified by age and gender. Minimal important differences were used to assess the clinical relevance of the findings. Data from one RCT with HRQoL scores available at baseline (n = 343) and four RCTs with HRQoL scores available at follow-up (n = 1665) were analyzed. RESULTS: Patients reported worse HRQoL scores than survivors across most functioning scales and symptoms' scales. These scores varied as a function of gender but not age. Survivors' HRQoL reports were comparable to the ones of the general population. CONCLUSIONS: These values provide an assessment framework for the comparison and interpretation of QLQ-C30 scores in advanced-stage HL. Our findings suggest that although HL patients' HRQoL scores are worse than the general population, HRQoL scores may normalize over long-term survival.

Compliance and Retention With the Experience Sampling Method Over the Continuum of Severe Mental Disorders: Meta-Analysis and Recommendations.

BACKGROUND: Despite the growing interest in the experience sampling method (ESM) as a data collection tool for mental health research, the absence of methodological guidelines related to its use has resulted in a large heterogeneity of designs. Concomitantly, the potential effects of the design on the response behavior of the participants remain largely unknown. OBJECTIVE: The objective of this meta-analysis was to investigate the associations between various sample and design characteristics and the compliance and retention rates of studies using ESM in mental health research. METHODS: ESM studies investigating major depressive disorder, bipolar disorder, and psychotic disorder were considered for inclusion. Besides the compliance and retention rates, a number of sample and design characteristics of the selected studies were collected to assess their potential relationships with the compliance and retention rates. Multilevel random/mixed effects models were used for the analyses. RESULTS: Compliance and retention rates were lower for studies with a higher proportion of male participants (P<.001) and individuals with a psychotic disorder (P<.001). Compliance was positively associated with the use of a fixed sampling scheme (P=.02), higher incentives (P=.03), higher time intervals between successive evaluations (P=.02), and fewer evaluations per day (P=.008), while no significant associations were observed with regard to the mean age of the sample, the study duration, or other design characteristics. CONCLUSIONS: The findings demonstrate that ESM studies can be carried out in mental health research, but the quality of the data collection depends upon a number of factors related to the design of ESM studies and the samples under study that need to be considered when designing such protocols.

Experience sampling methodology in mental health research: new insights and technical developments.

In the mental health field, there is a growing awareness that the study of psychiatric symptoms in the context of everyday life, using experience sampling methodology (ESM), may provide a powerful and necessary addition to more conventional research approaches. ESM, a structured self-report diary technique, allows the investigation of experiences within, and in interaction with, the real-world context. This paper provides an overview of how zooming in on the micro-level of experience and behaviour using ESM adds new insights and additional perspectives to standard approaches. More specifically, it discusses how ESM: a) contributes to a deeper understanding of psychopathological phenomena, b) allows to capture variability over time, c) aids in identifying internal and situational determinants of variability in symptomatology, and d) enables a thorough investigation of the interaction between the person and his/her environment and of real-life social interactions. Next to improving assessment of psychopathology and its underlying mechanisms, ESM contributes to advancing and changing clinical practice by allowing a more fine-grained evaluation of treatment effects as well as by providing the opportunity for extending treatment beyond the clinical setting into real life with the development of ecological momentary interventions. Furthermore, this paper provides an overview of the technical details of setting up an ESM study in terms of design, questionnaire development and statistical approaches. Overall, although a number of considerations and challenges remain, ESM offers one of the best opportunities for personalized medicine in psychiatry, from both a research and a clinical perspective.

Data quality and feasibility of the Experience Sampling Method across the spectrum of severe psychiatric disorders: a protocol for a systematic review and meta-analysis.

BACKGROUND: Due to a number of methodological advantages and theoretical considerations, more and more studies in clinical psychology research employ the Experience Sampling Method (ESM) as a data collection technique. Despite this growing interest, the absence of methodological guidelines related to the use of ESM has resulted in a large heterogeneity of designs while the potential effects of the design itself on the response behavior of the participants remain unknown. The objectives of this systematic review are to investigate the associations between the design characteristics and the data quality and feasibility of studies relying on ESM in severe psychiatric disorders. METHODS: We will search for all published studies using ambulatory assessment with patients suffering from major depressive disorder, bipolar disorder, and psychotic disorder or individuals at high risk for these disorders. Electronic database searches will be performed in PubMed and Web of Science with no restriction on the publication date. Two reviewers will independently screen original studies in a title/abstract phase and a full-text phase based on the inclusion criteria. The information related to the design and sample characteristics, data quality, and feasibility will be extracted. We will provide results in terms of a descriptive synthesis, and when applicable, a meta-analysis of the findings will be conducted. DISCUSSION: Our results will attempt to highlight how the feasibility and data quality of ambulatory assessment might be related to the methodological characteristics of the study designs in severe psychiatric disorders. We will discuss these associations in different subsamples if sufficient data are available and will examine limitations in the reporting of the methods of ambulatory studies in the current literature. SYSTEMATIC REVIEW REGISTRATION: The protocol for this systematic review was registered on PROSPERO (PROSPERO 2017: CRD42017060322 ) and is available in full on the University of York website ( http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42017060322 ).

Repeated self-evaluations may involve familiarization: An exploratory study related to Ecological Momentary Assessment designs in patients with major depressive disorder.

A growing body of research in clinical psychology is now relying on Ecological Momentary Assessment (EMA). EMA is fitted to investigate fluctuating processes and as such, it is of particular interest in a clinical context in which patients are often characterized by fluctuating behaviors and affective states or symptoms. EMA typically involves frequent self-evaluations over long periods, which may influence patient response. The present study aimed to determine whether EMA follow-ups could influence the participants' self-evaluations over time. The sample comprised 24 outpatients suffering from a Major Depressive Disorder (15 women, age = 51.4 ± 9.6). This study relied on an EMA protocol involving self-evaluations of seven depressive symptoms twice a day over 5 months. Patients did not show any clinical improvement following the clinical screening and the level of depressive symptoms during the follow-up. As a novel finding, significant moderate to large effects were observed for decreased variability and instability of psychological states over time. The main difference in temporal properties of psychological states was found after the first two weeks of the follow-up. This study characterized early changes in patients' self-evaluations, suggesting the idea of a valuable familiarization period during the first two weeks of an EMA follow-up.

Effect of Repetitive Transcranial Magnetic Stimulation on Psychomotor Retardation in Major Depression: A Pilot Feasibility Study.

This pilot study investigated the feasibility of a comprehensive battery of tests assessing psychomotor retardation after a 3-week protocol of repetitive transcranial magnetic stimulation for depression. In addition to the beneficial effect of this treatment on depression, the results showed positive changes in psychomotor retardation.

Balance characteristics in patients with major depression after a two-month walking exercise program: A pilot study.

UNLABELLED: Recent studies have demonstrated impaired balance performance in patients with major depressive disorder (MDD) in comparison to healthy controls (HC), which is likely to be related to deficits in integration of visual and proprioceptive inputs necessary for efficient postural control. In parallel, considerable literature supports the positive effects of a walking program on depressive symptoms. Thus this study aimed to determine the effects of a two-month walking program on implicit postural control strategies in MDD. Compared with twelve age- and body mass index-matched non-psychiatric HC (mean age 50.41 ± 6.93 years; five women), nine MDD (mean age 51.88 ± 10.01 years; five women) performed two sessions of standing postural control assessment, separated by eight weeks of the walking program, while the HC were only assessed at t0. The walking program included one-hour supervised walking sessions, three times a week over a two-month period. Postural performance was assessed by various center of pressure (COP) parameters, in particular those that bound the COP velocity of postural sway. The primary findings were that MDD patients exhibited positive physical activity-related changes in postural performance, with a decrease in body sway in the most difficult condition (with a foam surface). The real impact of the walking program on COP velocity-based variables suggests that MDD patients improved their ability to make more efficient postural corrections, which is useful for daily activities and autonomy. A balance assessment in the clinical screening routine might be used as a new index of the effectiveness of walking programs recommended for people with depression. TRIAL REGISTRATION: This study is registered at http://clinicaltrials.gov/: NCT01995422.