Feasibility of a home-based home videogaming intervention with a family-centered approach for children with cerebral palsy: a randomized multiple baseline single-case experimental design.

BACKGROUND: Worldwide, children with cerebral palsy (CP) living in underserved communities face barriers to accessing motor therapy services. This study assessed the implementation and effectiveness of an 8-week, upper limb (UL) home-based intervention with a movement-tracking videogame (Bootle Blast) in Costa Rican children with CP. METHODS: Children established a weekly playtime goal and two UL activities of daily living (ADLs) that they would like to improve on. A multiple-baseline, single-case experimental design, was used with the Performance Quality Rating Scale (PQRS) as the repeated measure to track changes in performance of the selected ADLs between the baseline (usual care) and intervention (Bootle Blast) phases. The Canadian Occupational Performance Measure (COPM), the Box and Blocks Test (BBT) and the Children's Hand-Use Experience Questionnaire (CHEQ) were collected before and after the intervention. Technical barriers were documented during weekly video calls with a monitoring therapist. Treatment effect size, slope changes and percentage of non-overlapping data were identified for the PQRS. Descriptive statistics summarized results for the BBT, CHEQ, videogame logs (e.g., playtime) and technical barriers. RESULTS: Fifteen children participated and 13 completed the intervention. Both participants who dropped out did so after completing baseline assessments, but before experiencing Bootle Blast. Children's mean active playtime (i.e., mini-games targeting the UL) across the 8-weeks was 377 min, while mean total time spent engaging with Bootle Blast (active + passive play time [e.g., time navigating menus, reviewing rewards]) was 728 min. In total, eight technical issues (from five children) were reported, and all but three were resolved within 48 h. Partial effectiveness was associated with the intervention. Specifically, 85% of participants improved on the PQRS and 69% achieved clinically important improvements ≥ 2 points in performance on the COPM. Children improved by 1.8 blocks on average on the BBT, while on the CHEQ, five children had a clinically important increase of 10% of the total number of UL activities performed with both hands. CONCLUSION: Bootle Blast is a feasible and effective option to facilitate access and engage children with cerebral palsy in UL home rehabilitation. Trial registration Trial registration number: NCT05403567.

The influence of procedural characteristics on within-case effect sizes for academic outcomes.

Single-case experimental designs (SCEDs) have been used with increasing frequency to identify evidence-based interventions in education. The purpose of this study was to explore how several procedural characteristics, including within-phase variability (i.e., measurement error), number of baseline observations, and number of intervention observations influenced the magnitude of four SCED effect sizes, including (a) non-overlap of all pairs (NAP), (b) baseline corrected tau (BC-Tau), (c) mean-phase difference (MPD), and (d) generalized least squares (GLS) when applied to hypothetical academic intervention SCED data. Higher levels of measurement error decreased the average magnitude of effect sizes, particularly NAP and BC-Tau. However, the number of intervention observations had minimal impact on the average magnitude of NAP and BC-Tau. Increasing the number of intervention observations dramatically increased the magnitude of GLS and MPD. Increasing the number of baseline observations also tended to increase the average magnitude of MPD. The ratio of baseline to intervention observations had a statistically but not practically significant influence on the average magnitude of NAP, BC-Tau, and GLS. Careful consideration is required when determining the length of time academic SCEDs are conducted and what effect sizes are used to summarize treatment outcomes. This article also highlights the value of using meaningful simulation conditions to understand the performance of SCED effect sizes.

Model selection of GLMMs in the analysis of count data in single-case studies: A Monte Carlo simulation.

Generalized linear mixed models (GLMMs) have great potential to deal with count data in single-case experimental designs (SCEDs). However, applied researchers have faced challenges in making various statistical decisions when using such advanced statistical techniques in their own research. This study focused on a critical issue by investigating the selection of an appropriate distribution to handle different types of count data in SCEDs due to overdispersion and/or zero-inflation. To achieve this, I proposed two model selection frameworks, one based on calculating information criteria (AIC and BIC) and another based on utilizing a multistage-model selection procedure. Four data scenarios were simulated including Poisson, negative binominal (NB), zero-inflated Poisson (ZIP), and zero-inflated negative binomial (ZINB). The same set of models (i.e., Poisson, NB, ZIP, and ZINB) were fitted for each scenario. In the simulation, I evaluated 10 model selection strategies within the two frameworks by assessing the model selection bias and its consequences on the accuracy of the treatment effect estimates and inferential statistics. Based on the simulation results and previous work, I provide recommendations regarding which model selection methods should be adopted in different scenarios. The implications, limitations, and future research directions are also discussed.

A Systematic Quality Review of Single-Case Experimental Designs Using Acceptance and Commitment Therapy in Adult Clinical Populations.

Recent publications within Contextual Behavioral Science provided a rationale for the expansion of intervention efficacy research using methods that capture idiographic factors and processes. We conducted a systematic review of the use and quality of single-case experimental designs (SCED) within the Acceptance and Commitment Therapy (ACT) literature in adult clinical populations. The systematic review was conducted according to PRISMA guidelines and the databases CINAHL, MEDLINE, PsycINFO, PsycArticles and OpenGrey were searched for peer-reviewed articles. Further studies were sought through review of reference lists of all full text studies. Studies were assessed against What Works Clearinghouse (WWC) single-case design standards. Twenty-six studies met eligibility criteria and were conducted within research teams all implementing multiple-baseline designs. Twenty-four studies did not meet WWC standards with most failing to ensure a degree of concurrence across participants. The extent of randomisation methods was also captured. The review highlights the sparsity of SCEDs within ACT literature in clinical populations and current methodological practices. Limitations of the review and implications for future research are discussed.

Academic and behavior combined support: A single-case practice-based replication study.

The purpose of this research was to conduct a practice-based replication of Academic and Behavior Combined Support (ABC Support), a previously developed and experimentally evaluated supplemental intervention that merges a combined focus on reading fluency and academic engagement. In the present study, a school-based interventionist and data collector had access to implementation resources online and participated in virtual training and coaching. Four Grade 2 students received the ABC Support intervention for 6 weeks in their school. Students' oral fluency on training and non-training reading passages, as well as occurrence of engagement and disruptive behaviors during universal reading instruction, were measured repeatedly across baseline, intervention, and follow-up phases in a multiple-baseline design. In concert with prior empirical findings on ABC Support, analyses revealed improvement from baseline to intervention for both reading and behavior outcomes, as well as from baseline to follow-up assessments. Empirical contributions of the study are offered within the context of replication research and an implementation science perspective. We also emphasize the importance of telecommunication for practice-based research evaluation of interventions.

Neuromuscular electrical stimulation to combat cognitive aging in people with spinal cord injury: protocol for a single case experimental design study.

INTRODUCTION: Individuals with spinal cord injury (SCI) can experience accelerated cognitive aging. Myokines (factors released from muscle cells during contractions), such as brain-derived neurotrophic factor (BDNF), are thought to have beneficial effects on cognition. Neuromuscular electrical stimulation (NMES) was shown to elicit a large release of myokines. However, the effects of NMES on cognitive function have not been studied. OBJECTIVE: To present the study protocol for a clinical trial evaluating the effects of NMES aimed at improving cognition and BDNF. METHODS: A replicated randomized three-phases single-case experimental design (SCED) with sequential multiple baseline time series and a single-armed prospective trial will be conducted with 15 adults with chronic SCI (> 12 months after injury) above L1 neurological level undergoing 30-min quadriceps NMES, 3 days per week for 12 weeks. MAIN STUDY ENDPOINTS: Primary endpoint is cognitive performance (assessed by a smartphone test) conducted three times per week during the baseline phase with random duration of 3 to 8 weeks, the intervention phase of 12 weeks, and the follow-up phase of 3 weeks after a no measurement rest period of 12 weeks. Secondary endpoints are changes in BDNF levels and cognitive performance measured before the baseline period, before and after intervention and after a 12 weeks follow-up. CONCLUSION: This will be the first study investigating the effects of 12 weeks NMES on both cognition and BDNF levels in individuals with SCI. The SCED results provide information on individual treatment effect courses which may direct future research. TRIAL REGISTRATION: ClinicalTrials.gov (NCT05822297, 12/01/2023).

Reading instruction for students with intellectual disabilities who require augmentative and alternative communication: A multiple single case study with baseline, posttest, follow-up, and maintenance.

The purpose of the current study was to examine whether seven children, aged 6-10 years, with intellectual disabilities who require augmentative and alternative communication, could acquire phonological awareness and reading skills by using a reading material that is based on research on the evidence-based reading program Accessible literacy learning. The effect of the measures has been examined using a multiple single-case design with baseline, posttest, follow-up, and maintenance. All the teachers were trained to deliver the reading intervention in the students' familiar place at school. The results indicated that students with intellectual disabilities who require augmentative and alternative communication could acquire phonological awareness and decoding by working systematically with reading material based on evidence-based strategies.

The effect of an online acceptance and commitment intervention on the meaning-making process in cancer patients following hematopoietic cell transplantation: study protocol for a randomized controlled trial enhanced with single-case experimental design.

BACKGROUND: Hematopoietic cell transplantation (HCT) is a highly invasive and life-threatening treatment for hematological neoplasms and some types of cancer that can challenge the patient's meaning structures. Restoring meaning (i.e., building more flexible and significant explanations of the disease and treatment burden) can be aided by strengthening psychological flexibility by means of an Acceptance and Commitment Therapy (ACT) intervention. Thus, this trial aims to examine the effect of the ACT intervention on the meaning-making process and the underlying mechanisms of change in patients following HCT compared to a minimally enhanced usual care (mEUC) control group. The trial will be enhanced with a single-case experimental design (SCED), where ACT interventions will be compared between individuals with various pre-intervention intervals. METHODS: In total, 192 patients who qualify for the first autologous or allogeneic HCT will be recruited for a two-armed parallel randomized controlled trial comparing an online self-help 14-day ACT training to education sessions (recommendations following HCT). In both conditions, participants will receive once a day a short survey and intervention proposal (about 5-10 min a day) in the outpatient period. Double-blinded assessment will be conducted at baseline, during the intervention, immediately, 1 month, and 3 months after the intervention. In addition, 6-9 participants will be invited to SCED and randomly assigned to pre-intervention measurement length (1-3 weeks) before completing ACT intervention, followed by 7-day observations at the 2nd and 3rd post-intervention measure. The primary outcome is meaning-related distress. Secondary outcomes include psychological flexibility, meaning-making coping, meanings made, and well-being as well as global and situational meaning. DISCUSSION: This trial represents the first study that integrates the ACT and meaning-making frameworks to reduce meaning-related distress, stimulate the meaning-making process, and enhance the well-being of HCT recipients. Testing of an intervention to address existential concerns unique to patients undergoing HCT will be reinforced by a statistically rigorous idiographic approach to see what works for whom and when. Since access to interventions in the HCT population is limited, the web-based ACT self-help program could potentially fill this gap. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT06266182. Registered on February 20, 2024.

Effect of digital game intervention on cognitive functions in older adults: a multiple baseline single case experimental design study.

BACKGROUND: Residents in nursing homes are prone to cognitive decline affecting memory, visuospatial cognition, and executive functions. Cognitive decline can lead to dementia, necessitating prioritized intervention. METHODS: The current study aimed to investigate whether an intervention using a digital game was effective for preserving and improving the cognitive function of residents in nursing homes. An intervention study was conducted using a single-case AB design with multiple baselines. The participants in the study were five older adults aged 65 and over who do not play digital games regularly. The study ran for 15 weeks, including a baseline (phase A) and an intervention phase (phase B). Phase A had five baselines (5 to 9 weeks) with random participant assignment. In phase B, participants engaged in a digital game (Space Invaders) individually. Cognitive function was assessed as the outcome, measured using the Brain Assessment (performed on a tablet through the Internet) at 16 measurement points. Four of five participants (two female and two male) were included in the analysis, using visual inspection and Bayesian statistics with multi-level modeling. RESULTS: Visual inspection of the graphs revealed cognitive function score improvements after the intervention for most layers in terms of memory of numbers, memory of words, mental rotation test (visuospatial ability), and total scores in the Brain Assessment. These effects were also significant in the analysis by multi-level modeling. CONCLUSIONS: The results suggest that the use of digital games may be effective for preserving and improving cognitive function among residents of nursing home. TRIAL REGISTRATION: This study was registered in the University Hospital Medical Information Network Clinical Trials Registry (UMIN000048677; public title: Effect of a Digital Game Intervention for Cognitive Functions in Older People; registration date: August 30, 2022).

The effects of person-centred active rehabilitation on symptoms of suspected Chronic Traumatic Encephalopathy: A mixed-methods single case design.

OBJECTIVE: The objective was to investigate the effectiveness of a person-centred active rehabilitation programme on symptoms associated with suspected Chronic Traumatic Encephalopathy (CTE). This was accomplished by (1) assessing the effect that a person-centred active rehabilitation programme had on participant symptoms, and (2) exploring how temporal contextual factors affected the participants' experience with, and perceived effectiveness of, the active rehabilitation programme. METHODS: A twelve-month mixed-methods single case experimental research design was used with six cases (participants). Individual cases were involved in a 51-week study period including an initial interview and three-week baseline phase. Cases were then randomly allocated to one of two n-of-1 study designs (i.e., A-B, B-A, B-A, A-B or B-A, A-B, A-B, B-A) where A and B represent a non-intervention and intervention phase, respectively. Interviews were conducted regularly throughout the study whilst outcome measures were assessed at each follow-up. Analysis of the data included visual, statistical, and qualitative analysis. RESULTS: Visual and statistical analysis of cognitive and executive function, and mindful attention, demonstrated trivial-to-large effects with the summary reflecting positive or unclear results. A mixed picture was observed for mood and behaviour with effects considered trivial-to-large, and the summary demonstrating positive, unclear and negative effects. Qualitative analysis indicated a perceived improvement in outcome measures such as memory, attention, anxiety, and emotional control despite mixed quantitative findings whilst a clear impact of contextual factors, such as COVID-19, the political atmosphere, exercise tolerance, programme progression, and motivation were evident during the intervention. CONCLUSIONS: This study has provided primary-level evidence to suggest active rehabilitation as a potential intervention for the management of suspected CTE symptoms. This study has also demonstrated the benefit of a person-centred approach to both clinical research and practice, particularly by considering contextual factors for a better understanding of an intervention effect.

Highly sensitive serum volatolomic biomarkers for pancreatic cancer diagnosis.

The discovery of new diagnostic tools for the early detection of diseases with poor prognosis such as pancreatic adenocarcinoma (PAC) is of high importance. The results from a control-case study (20 PAC patients, 19 healthy controls) for the search of new biomarkers of pancreatic cancer based in differences in the serum volatolome are presented in this work. Volatolomics were performed following a non-targeted HS-SPME-GC/MS approach, and a total of 433 volatile organic compounds (VOCs) was detected in the human serum samples. Of these, 125 VOC indexes showed a significant variation when controls and patients were compared (p-value < 0.05). Bonferroni corrected p-values < 0.05 were found for 40 features. PCA analysis showed the control-PAC discrimination capability of VOCs in serum, and PLS-DA was performed to select the best candidate biomarkers for the diagnosis of PAC. For the 40 selected VOCs, calculated areas under the curve (AUC) ranged from 0.98 to 0.85, and 11 of them were successfully validated using an independent set of samples (5 PAC patients, 5 healthy controls). Four of the proposed PAC biomarkers were identified as toluene, 2-ethyl-1-hexanol, pentylbenzene, and butoxymethylbenzene. Combinations of the identified PAC biomarkers were tested and showed AUC > 0.90, with the more promising candidate being butoxymethylbenzene (AUC = 0.98).

Efficacy of an Intensive Exposure Intervention for Individuals With Persistent Concussion Symptoms Following Concussion: A Concurrent Multiple Baseline Single-Case Experimental Design (SCED) Study.

OBJECTIVE: After a concussion, 1 in 3 patients report persistent symptoms and experience long-term consequences interfering with daily functioning, known as persistent concussion symptoms (PCS). Evidence suggests PCS is (partly) maintained by anxious thoughts about brain functioning, recovery, and experienced symptoms, leading to avoidance behaviors, which may prevent patients from meeting life demands. We aimed to investigate the efficacy of a newly developed intensive exposure intervention for individuals with PCS after concussion aimed to tackle avoidance behavior. SETTING: Participants took part in the intervention at the Maastricht University faculty. PARTICIPANTS: Four participants who experienced PCS after concussion partook in the exploratory study. Participants' age ranged between 20 and 32 (mean = 26.5, SD = 5.9) years, with an average length of time after the concussion of 9.8 months. DESIGN: A concurrent multiple-baseline single-case design was conducted. The baseline period (A phase) length was randomly determined across participants (3, 4, 5, or 6 weeks). The exposure intervention (B phase) was conducted by psychologists over a 4-week period and consisted of 3 stages: exploration (2 sessions), active exposure (12 sessions conducted over 1 week), and 2 booster sessions. MAIN MEASURES: Participants answered daily questions on a visual analog scale related to symptom experience, satisfaction with daily functioning, and degree of avoidance of feared activities. Additional outcomes included symptom severity, catastrophizing, fear of mental activity, anxiety, depression, and societal participation. RESULTS: Tau-U yielded significant effects ( P < .05) for all participants on all measures when comparing baseline and intervention phases. The pooled standardized mean difference was high for all measures (symptom experience = 0.93, satisfaction of daily functioning = 1.86, and activity avoidance = -2.05). CONCLUSIONS: The results show efficacy of the newly developed intensive exposure treatment for PCS after concussion, which is based on the fear avoidance model. Replication in a larger heterogeneous sample is warranted and needed.

Leveraging Single-Case Experimental Designs to Promote Personalized Psychological Treatment: Step-by-Step Implementation Protocol with Stakeholder Involvement of an Outpatient Clinic for Personalized Psychotherapy.

Our objective is to implement a single-case experimental design (SCED) infrastructure in combination with experience-sampling methods (ESM) into the standard diagnostic procedure of a German outpatient research and training clinic. Building on the idea of routine outcome monitoring, the SCED infrastructure introduces intensive longitudinal data collection, individual effectiveness measures, and the opportunity for systematic manipulation to push personalization efforts further. It aims to empower psychotherapists and patients to evaluate their own treatment (idiographic perspective) and to enable researchers to analyze open questions of personalized psychotherapy (nomothetic perspective). Organized around the principles of agile research, we plan to develop, implement, and evaluate the SCED infrastructure in six successive studies with continuous stakeholder involvement: In the project development phase, the business model for the SCED infrastructure is developed that describes its vision in consideration of the context (Study 1). Also, the infrastructure's prototype is specified, encompassing the SCED procedure, ESM protocol, and ESM survey (Study 2 and 3). During the optimization phase, feasibility and acceptability are tested and the infrastructure is adapted accordingly (Study 4). The evaluation phase includes a pilot implementation study to assess implementation outcomes (Study 5), followed by actual implementation using a within-institution A-B design (Study 6). The sustainability phase involves continuous monitoring and improvement. We discuss to what extent the generated data could be used to address current questions of personalized psychotherapy research. Anticipated barriers and limitations during the implementation processes are outlined.

Multilevel modeling in single-case studies with zero-inflated and overdispersed count data.

Count outcomes are frequently encountered in single-case experimental designs (SCEDs). Generalized linear mixed models (GLMMs) have shown promise in handling overdispersed count data. However, the presence of excessive zeros in the baseline phase of SCEDs introduces a more complex issue known as zero-inflation, often overlooked by researchers. This study aimed to deal with zero-inflated and overdispersed count data within a multiple-baseline design (MBD) in single-case studies. It examined the performance of various GLMMs (Poisson, negative binomial [NB], zero-inflated Poisson [ZIP], and zero-inflated negative binomial [ZINB] models) in estimating treatment effects and generating inferential statistics. Additionally, a real example was used to demonstrate the analysis of zero-inflated and overdispersed count data. The simulation results indicated that the ZINB model provided accurate estimates for treatment effects, while the other three models yielded biased estimates. The inferential statistics obtained from the ZINB model were reliable when the baseline rate was low. However, when the data were overdispersed but not zero-inflated, both the ZINB and ZIP models exhibited poor performance in accurately estimating treatment effects. These findings contribute to our understanding of using GLMMs to handle zero-inflated and overdispersed count data in SCEDs. The implications, limitations, and future research directions are also discussed.

Intrathecal magnesium delivery for Mg++-insensitive NMDA receptor activity due to GRIN1 mutation.

BACKGROUND: Mutations in the NMDA receptor are known to disrupt glutamatergic signaling crucial for early neurodevelopment, often leading to severe global developmental delay/intellectual disability, epileptic encephalopathy, and cerebral palsy phenotypes. Both seizures and movement disorders can be highly treatment-refractory. RESULTS: We describe a targeted ABA n-of-1 treatment trial with intrathecal MgSO4, rationally designed based on the electrophysiologic properties of this gain of function mutation in the GRIN1 NMDA subunit. CONCLUSION: Although the invasive nature of the trial necessitated a short-term, non-randomized, unblinded intervention, quantitative longitudinal neurophysiologic monitoring indicated benefit, providing class II evidence in support of intrathecal MgSO4 for select forms of GRIN disorders.

Comentario acerca del caso Belcebú / Commentary on the Beelzebub case / Commentaire sur le cas clinique de Belzébuth / Comentário sobre o caso Belzebu

A partir de la presentación del caso clínico de un niño de 10 años llamado Belcebú, atendido durante la pandemia de forma virtual a lo largo de un año y cuatro meses, se realiza un comentario teórico-clínico puntualizando los aspectos vinculados a:los enunciados identificatorios; el niño en la estructura familiar y, como aspecto más relevante, el lugar del juego producido en las sesiones, el que sostenido por la mirada posibilitadora de la analista, le permitió alniño elaborar y rescribir marcas identitarias,en pos de una subjetivación menos tanática AU

Based on the presentation of the clinical case of a 10-year-old boy named Belcebú, treated virtually during the pandemic for a yearand four months, a theoretical-clinical comment is made, pointing out the aspects related to: the identifying statements; the child in the family structure and, as a most relevant aspect, the place of the play produced in the sessions, which, supported by the analyst's enabling gaze, allowed the child to elaborate and rewrite identity marks, in pursuit of a less thanatic subjectivation AU

Sur la base de la présentation du cas clinique d'un garçon de 10 ans nommé Belcebú, traité virtuellement pendant la pandémie durant un an et quatre mois, un commentaire théorico-clinique est fait, soulignant les aspects liés:aux énoncés identifiants; l'enfant dans la structure familiale et, comme aspect le plus pertinent, la place du jeu produit dans les séances, qui, soutenu par le regard habilitant de l'analyste, a permis à l'enfant d'élaborer et de réécrire des marques identitaires, à la poursuite d'une subjectivation moins thanatique AU

A partir da apresentação do caso clínico de um menino de 10 anos chamado Belcebú, tratado virtualmente durante a pandemia por um ano e quatro meses, é feito um comentário teórico-clínico, apontando os aspectos relacionados: a os depoimentos identificadores; a criança na estrutura familiar e, como aspecto mais relevante, o lugar da brincadeira produzida nas sessões, que, amparada pelo olhar capacitador do analista, permitiu à criança elaborar e reescrever marcas identitárias, em busca de uma subjetivação menos tanática AU

Individualized Studies of Triggers of Paroxysmal Atrial Fibrillation: The I-STOP-AFib Randomized Clinical Trial.

Importance: Atrial fibrillation (AF) is the most common arrhythmia. Although patients have reported that various exposures determine when and if an AF event will occur, a prospective evaluation of patient-selected triggers has not been conducted, and the utility of characterizing presumed AF-related triggers for individual patients remains unknown. Objective: To test the hypothesis that n-of-1 trials of self-selected AF triggers would enhance AF-related quality of life. Design, Setting, and Participants: A randomized clinical trial lasting a minimum of 10 weeks tested a smartphone mobile application used by symptomatic patients with paroxysmal AF who owned a smartphone and were interested in testing a presumed AF trigger. Participants were screened between December 22, 2018, and March 29, 2020. Interventions: n-of-1 Participants received instructions to expose or avoid self-selected triggers in random 1-week blocks for 6 weeks, and the probability their trigger influenced AF risk was then communicated. Controls monitored their AF over the same time period. Main Outcomes and Measures: AF was assessed daily by self-report and using a smartphone-based electrocardiogram recording device. The primary outcome comparing n-of-1 and control groups was the Atrial Fibrillation Effect on Quality-of-Life (AFEQT) score at 10 weeks. All participants could subsequently opt for additional trigger testing. Results: Of 446 participants who initiated (mean [SD] age, 58 [14] years; 289 men [58%]; 461 White [92%]), 320 (72%) completed all study activities. Self-selected triggers included caffeine (n = 53), alcohol (n = 43), reduced sleep (n = 31), exercise (n = 30), lying on left side (n = 17), dehydration (n = 10), large meals (n = 7), cold food or drink (n = 5), specific diets (n = 6), and other customized triggers (n = 4). No significant differences in AFEQT scores were observed between the n-of-1 vs AF monitoring-only groups. In the 4-week postintervention follow-up period, significantly fewer daily AF episodes were reported after trigger testing compared with controls over the same time period (adjusted relative risk, 0.60; 95% CI, 0.43- 0.83; P < .001). In a meta-analysis of the individualized trials, only exposure to alcohol was associated with significantly heightened risks of AF events. Conclusions and Relevance: n-of-1 Testing of AF triggers did not improve AF-associated quality of life but was associated with a reduction in AF events. Acute exposure to alcohol increased AF risk, with no evidence that other exposures, including caffeine, more commonly triggered AF. Trial Registration: ClinicalTrials.gov Identifier: NCT03323099.

Adaptive single case design (ASCD): a model for education, training, and assessment / Estudo de caso único adaptado (ASCD): um modelo para educação, treinamento e avaliação

Aims: single case designs (SCDs) can help us understand change in learning-related variables, such as knowledge and skill, at the level of an individual learner, at the level of a team or group of learners, or at the level of a situation or system. Adaptive single case design (ASCD) is a new model that integrates (i.) elements of methods of education, training, and assessment that, through research methods other than SCDs, have received solid empirical evidence in the research literature and (ii.) principles of SCDs that can facilitate the integration of research in everyday practice. The rationale behind ASCD is to allow rapid evidence-based decision making in the practice of education, training, and assessment, at the unit of analysis ­ individual, group, team, situation, or system ­ that is considered appropriate in the context at hand. Method: an ASCD algorithm is introduced and discussed in the context of change at the level of the individual, change in a group or team, and change in a situation or system. Results: ASCD can be used to understand change at each of the previously mentioned units of analysis at any number of units including a single unit (one individual, one team, or one situation or system), and this change can be used for research purposes as well. Conclusion: ASCD enables both evidence-based practical decision making and research without stringent demands on the number of learners, groups, teams, situations, or systems.

Objetivos: estudos de caso único podem nos ajudar a entender a mudança nas variáveis relacionadas ao aprendizado, como conhecimento e habilidade, no nível de um aluno individual, no nível de uma equipe ou grupo de alunos, ou no nível de uma situação ou sistema. O Estudo adaptativo de caso único (ASCD) é um novo modelo que integra (i.) elementos de métodos de educação, treinamento e avaliação que, por meio de métodos de pesquisa que não sejam estudos de caso único, receberam evidências empíricas sólidas na literatura de pesquisa e (ii.) princípios de estudos de caso único, que podem facilitar a integração da pesquisa na prática cotidiana. A lógica por trás do ASCD é permitir a rápida tomada de decisão baseada em evidências na prática da educação, treinamento e avaliação, na unidade de análise ­ individual, grupo, equipe, situação ou sistema ­ que é considerada apropriada no contexto em questão. Método: um algoritmo ASCD é introduzido e discutido no contexto de mudança no nível do indivíduo, mudança em um grupo ou equipe e mudança em uma situação ou sistema. Resultados: o ASCD pode ser usado para entender a mudança em cada uma das unidades de análise mencionadas anteriormente em qualquer número de unidades, incluindo uma única unidade (um indivíduo, uma equipe ou uma situação ou sistema), e para fins de pesquisa. Conclusão: o ASCD permite a a pesquisa e a tomada de decisão prática baseada em evidências, sem demandas rigorosas sobre o número de alunos, grupos, equipes, situações ou sistemas.