Effectiveness and tolerability of brivaracetam in patients with epilepsy stratified by comorbidities and etiology in the real world: 12-month subgroup data from the international EXPERIENCE pooled analysis.

OBJECTIVE: To assess the effectiveness and tolerability of brivaracetam (BRV) in adults with epilepsy by specific comorbidities and epilepsy etiologies. METHODS: EXPERIENCE/EPD332 was a pooled analysis of individual patient records from several non-interventional studies of patients with epilepsy initiating BRV in clinical practice. Outcomes included ≥ 50% reduction from baseline in seizure frequency, seizure freedom (no seizures within prior 3 months), continuous seizure freedom (no seizures since baseline), BRV discontinuation, and treatment-emergent adverse events (TEAEs) at 3, 6, and 12 months. Analyses were performed for all adult patients (≥ 16 years of age) and stratified by comorbidity and by etiology at baseline (patients with cognitive/learning disability [CLD], psychiatric comorbidity, post-stroke epilepsy, brain tumor-related epilepsy [BTRE], and traumatic brain injury-related epilepsy [TBIE]). RESULTS: At 12 months, ≥ 50% seizure reduction was achieved in 35.6% (n = 264), 38.7% (n = 310), 41.7% (n = 24), 34.1% (n = 41), and 50.0% (n = 28) of patients with CLD, psychiatric comorbidity, post-stroke epilepsy, BTRE, and TBIE, respectively; and continuous seizure freedom was achieved in 5.7% (n = 318), 13.7% (n = 424), 29.4% (n = 34), 11.4% (n = 44), and 13.8% (n = 29), respectively. During the study follow-up, in patients with CLD, psychiatric comorbidity, post-stroke epilepsy, BTRE, and TBIE, 37.1% (n = 403), 30.7% (n = 605), 33.3% (n = 51), 39.7% (n = 68), and 27.1% (n = 49) of patients discontinued BRV, respectively; and TEAEs since prior visit at 12 months were reported in 11.3% (n = 283), 10.0% (n = 410), 16.7% (n = 36), 12.5% (n = 48), and 3.0% (n = 33), respectively. CONCLUSIONS: BRV as prescribed in the real world is effective and well tolerated among patients with CLD, psychiatric comorbidity, post-stroke epilepsy, BTRE, and TBIE.

Face-to-face and telephone appointments in the seizure clinic: A comparative analysis based on recorded interactions.

OBJECTIVE: Telephone appointments are now widely used in seizure treatment, but there is little understanding of how they compare to face-to-face appointments. Studies from other fields suggest that comparisons can be done on three levels: 1) Abstract level: duration of appointment. 2) Structural level: distribution of talk. 3) Detailed level: aspects of communication. This study aims to compare seizure clinic face-to-face and telephone appointments based on their duration, distribution of talk, and the number of questions asked by patients/companions. METHODS: Statistical comparison between recordings and transcripts of 34 telephone appointments (recorded in 2021) and 56 face-to-face appointments (recorded in 2013). RESULTS: There was no significant difference between the duration of face-to-face (median: 16.5 min) and telephone appointments (median: 16.2 min). There was no significant difference in the ratio of neurologist to patient/companion talk (face-to-face: 55% vs. 45%, telephone: 54% vs. 46%). Patients/companions asked significantly more questions per minute in face-to-face (median: 0.17) than telephone appointments (median: 0.06, p < 0.05). CONCLUSION: At a broad level, seizure clinic face-to-face and telephone appointments are similar. Examining the details of the interaction, however, reveals important differences in questioning. PRACTICE IMPLICATIONS: Practitioners could take steps to facilitate patient questioning in telephone appointments.

'Knowledge exchange' workshops to optimise development of a risk prediction tool to assist conveyance decisions for suspected seizures - Part of the Risk of ADverse Outcomes after a Suspected Seizure (RADOSS) project.

PURPOSE: Suspected seizures present challenges for ambulance services, with paramedics reporting uncertainty over whether or not to convey individuals to emergency departments. The Risk of ADverse Outcomes after a Suspected Seizure (RADOSS) project aims to address this by developing a risk assessment tool utilizing structured patient care record and dispatch data. It proposes a tool that would provide estimates of an individual's likelihood of death and/or recontact with emergency care within 3 days if conveyed compared to not conveyed, and the likelihood of an 'avoidable attendance' occurring if conveyed. Knowledge Exchange workshops engaged stakeholders to resolve key design uncertainties before model derivation. METHOD: Six workshops involved 26 service users and their significant others (epilepsy or nonepileptic attack disorder), and 25 urgent and emergency care clinicians from different English ambulance regions. Utilizing Nominal Group Techniques, participants shared views of the proposed tool, benefits and concerns, suggested predictors, critiqued outcome measures, and expressed functionality preferences. Data were analysed using Hamilton's Rapid Analysis. RESULTS: Stakeholders supported tool development, proposing 10 structured variables for predictive testing. Emphasis was placed on the tool supporting, not dictating, care decisions. Participants highlighted some reasons why RADOSS might struggle to derive a predictive model based on structured data alone and suggested some non-structured variables for future testing. Feedback on prediction timeframes for service recontact was received, along with advice on amending the 'avoidable attendance' definition to prevent the tool's predictions being undermined by potential overuse of certain investigations in hospital. CONCLUSION: Collaborative stakeholder engagement provided crucial insights that can guide RADOSS to develop a user-aligned, optimized tool.

An update on psychogenic nonepileptic seizures.

PURPOSE OF REVIEW: The understanding of psychogenic nonepileptic seizures (PNES) has advanced steadily over recent decades. This update summarizes new insights from the last three years. RECENT FINDINGS: The process of diagnosing PNES has shifted from the exclusion of epilepsy to one based on the recognition of typical clinical features. While the diagnosis cannot rely on any single feature in isolation, a range of semiological features characterising PNES are now recognised and a number of studies hint at the potential for machine learning and AI to improve the diagnostic process. Advances in data processing and analysis may also help to make sense of the heterogeneity of PNES populations demonstrated by recent studies focussing on aetiology and patient subgroups. It is now clear that PNES are associated with high rates of mental and physical comorbidities and premature death, highlighting that they are only one manifestation of a complex disorder extending beyond the nervous system and the seizures themselves. SUMMARY: PNES are now understood as a manifestation of dysfunction in interacting brain networks. This understanding provides an explanation for the psychopathological and semiological heterogeneity of PNES patient populations. New insights into medical comorbidities and increased rates of premature death call for more research into associated pathological processes outside the nervous system.

Predicting the cause of seizures using features extracted from interactions with a virtual agent.

OBJECTIVE: A clinical decision tool for Transient Loss of Consciousness (TLOC) could reduce currently high misdiagnosis rates and waiting times for specialist assessments. Most clinical decision tools based on patient-reported symptom inventories only distinguish between two of the three most common causes of TLOC (epilepsy, functional /dissociative seizures, and syncope) or struggle with the particularly challenging differentiation between epilepsy and FDS. Based on previous research describing differences in spoken accounts of epileptic seizures and FDS seizures, this study explored the feasibility of predicting the cause of TLOC by combining the automated analysis of patient-reported symptoms and spoken TLOC descriptions. METHOD: Participants completed an online web application that consisted of a 34-item medical history and symptom questionnaire (iPEP) and spoken interaction with a virtual agent (VA) that asked eight questions about the most recent experience of TLOC. Support Vector Machines (SVM) were trained using different combinations of features and nested leave-one-out cross validation. The iPEP provided a baseline performance. Inspired by previous qualitative research three spoken language based feature sets were designed to assess: (1) formulation effort, (2) the proportion of words from different semantic categories, and (3) verb, adverb, and adjective usage. RESULTS: 76 participants completed the application (Epilepsy = 24, FDS = 36, syncope = 16). Only 61 participants also completed the VA interaction (Epilepsy = 20, FDS = 29, syncope = 12). The iPEP model accurately predicted 65.8 % of all diagnoses, but the inclusion of the language features increased the accuracy to 85.5 % by improving the differential diagnosis between epilepsy and FDS. CONCLUSION: These findings suggest that an automated analysis of TLOC descriptions collected using an online web application and VA could improve the accuracy of current clinical decisions tools for TLOC and facilitate clinical stratification processes (such as ensuring appropriate referral to cardiological versus neurological investigation and management pathways).

'I just need to know what they are and if you can help me': Medicalization and the search for legitimacy in people diagnosed with non-epileptic attack disorder.

This paper focuses on the struggles for legitimacy expressed by people with non-epileptic attack disorder (NEAD), one of the most common manifestations of functional neurological disorder presenting to emergency and secondary care services. Nonepileptic attacks are episodes of altered experience, awareness, and reduced self-control that superficially resemble epileptic seizures or other paroxysmal disorders but are not associated with physiological abnormalities sufficient to explain the semiological features. "Organic" or medicalized explanations are frequently sought by patients as the only legitimate explanation for symptoms, and consequently, a diagnosis of NEAD is often contested. Drawing on narrative interviews with patients from a small exploratory study and using a sociological perspective, we propose that a psychological account of NEAD does not provide a sufficiently legitimate path into a socially sanctioned sick role. This is a reflection of the dominance of biomedicine and the associated processes of medicalization. These processes are, we argue, the sole route to achieving legitimacy. The stress-based or psychologically oriented explanations offered to patients in contemporary medical models of the etiology of NEAD engender an uncertain identity and social position and fail to provide many patients with an account of the nature or origin of their symptoms that they find satisfactory or convincing. These struggles for legitimacy (shared by others with functional or somatoform conditions) are sharpened by key features of the contemporary healthcare landscape, such as the increasing framing of health through a lens of 'responsibilization'.

Effectiveness and Tolerability of 12-Month Brivaracetam in the Real World: EXPERIENCE, an International Pooled Analysis of Individual Patient Records.

BACKGROUND AND OBJECTIVE: Real-world evidence studies of brivaracetam (BRV) have been restricted in scope, location, and patient numbers. The objective of this pooled analysis was to assess effectiveness and tolerability of brivaracetam (BRV) in routine practice in a large international population. METHODS: EXPERIENCE/EPD332 was a pooled analysis of individual patient records from multiple independent non-interventional studies of patients with epilepsy initiating BRV in Australia, Europe, and the United States. Eligible study cohorts were identified via a literature review and engagement with country lead investigators, clinical experts, and local UCB Pharma scientific/medical teams. Included patients initiated BRV no earlier than January 2016 and no later than December 2019, and had ≥ 6 months of follow-up data. The databases for each cohort were reformatted and standardised to ensure information collected was consistent. Outcomes included ≥ 50% reduction from baseline in seizure frequency, seizure freedom (no seizures within 3 months before timepoint), continuous seizure freedom (no seizures from baseline), BRV discontinuation, and treatment-emergent adverse events (TEAEs) at 3, 6, and 12 months. Patients with missing data after BRV discontinuation were considered non-responders/not seizure free. Analyses were performed for all adult patients (≥ 16 years), and for subgroups by seizure type recorded at baseline; by number of prior antiseizure medications (ASMs) at index; by use of BRV as monotherapy versus polytherapy at index; for patients who switched from levetiracetam to BRV versus patients who switched from other ASMs to BRV; and for patients with focal-onset seizures and a BRV dose of ≤ 200 mg/day used as add-on at index. Analysis populations included the full analysis set (FAS; all patients who received at least one BRV dose and had seizure type and age documented at baseline) and the modified FAS (all FAS patients who had at least one seizure recorded during baseline). The FAS was used for all outcomes other than ≥ 50% seizure reduction. All outcomes were summarised using descriptive statistics. RESULTS: Analyses included 1644 adults. At baseline, 72.0% were 16-49 years of age and 92.2% had focal-onset seizures. Patients had a median (Q1, Q3) of 5.0 (2.0, 8.0) prior antiseizure medications at index. At 3, 6, and 12 months, respectively, ≥ 50% seizure reduction was achieved by 32.1% (n = 619), 36.7% (n = 867), and 36.9% (n = 822) of patients; seizure freedom rates were 22.4% (n = 923), 17.9% (n = 1165), and 14.9% (n = 1111); and continuous seizure freedom rates were 22.4% (n = 923), 15.7% (n = 1165), and 11.7% (n = 1111). During the whole study follow-up, 551/1639 (33.6%) patients discontinued BRV. TEAEs since prior visit were reported in 25.6% (n = 1542), 14.2% (n = 1376), and 9.3% (n = 1232) of patients at 3, 6, and 12 months, respectively. CONCLUSIONS: This pooled analysis using data from a variety of real-world settings suggests BRV is effective and well tolerated in routine clinical practice in a highly drug-resistant patient population.

Speech patterns in responses to questions asked by an intelligent virtual agent can help to distinguish between people with early stage neurodegenerative disorders and healthy controls.

Previous research has provided strong evidence that speech patterns can help to distinguish between people with early stage neurodegenerative disorders (ND) and healthy controls. This study examined speech patterns in responses to questions asked by an intelligent virtual agent (IVA): a talking head on a computer which asks pre-recorded questions. The study investigated whether measures of response length, speech rate and pausing in responses to questions asked by an IVA help to distinguish between healthy control participants and people diagnosed with Mild Cognitive Impairment (MCI) or Alzheimer's disease (AD). The study also considered whether those measures can further help to distinguish between people with MCI, people with AD, and healthy control participants (HC). There were 38 people with ND (31 people with MCI, 7 people with AD) and 26 HC. All interactions took place in English. People with MCI spoke fewer words compared to HC, and people with AD and people with MCI spoke for less time than HC. People with AD spoke at a slower rate than people with MCI and HC. There were significant differences across all three groups for the proportion of time spent pausing and the average pause duration: silent pauses make up the greatest proportion of responses from people with AD, who also have the longest average silent pause duration, followed by people with MCI then HC. Therefore, the study demonstrates the potential of an IVA as a method for collecting data showing patterns which can help to distinguish between diagnostic groups.

Anomalies in the review process and interpretation of the evidence in the NICE guideline for chronic fatigue syndrome and myalgic encephalomyelitis.

Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) is a disabling long-term condition of unknown cause. The National Institute for Health and Care Excellence (NICE) published a guideline in 2021 that highlighted the seriousness of the condition, but also recommended that graded exercise therapy (GET) should not be used and cognitive-behavioural therapy should only be used to manage symptoms and reduce distress, not to aid recovery. This U-turn in recommendations from the previous 2007 guideline is controversial.We suggest that the controversy stems from anomalies in both processing and interpretation of the evidence by the NICE committee. The committee: (1) created a new definition of CFS/ME, which 'downgraded' the certainty of trial evidence; (2) omitted data from standard trial end points used to assess efficacy; (3) discounted trial data when assessing treatment harm in favour of lower quality surveys and qualitative studies; (4) minimised the importance of fatigue as an outcome; (5) did not use accepted practices to synthesise trial evidence adequately using GRADE (Grading of Recommendations, Assessment, Development and Evaluations trial evidence); (6) interpreted GET as mandating fixed increments of change when trials defined it as collaborative, negotiated and symptom dependent; (7) deviated from NICE recommendations of rehabilitation for related conditions, such as chronic primary pain and (8) recommended an energy management approach in the absence of supportive research evidence.We conclude that the dissonance between this and the previous guideline was the result of deviating from usual scientific standards of the NICE process. The consequences of this are that patients may be denied helpful treatments and therefore risk persistent ill health and disability.

Subjective seizure symptom reporting in functional/dissociative seizures and epilepsy: Effects of sampling technique and patient characteristics.

BACKGROUND: Differences in subjectively reportable ictal experiences between epilepsy and functional/dissociative seizures (FDS) have received less attention than visible manifestations. Patients with FDS (pwFDS) tend to report seizure symptoms differently than patients with epilepsy (pwE). The effects of symptom elicitation method and mediation by psychopathological traits have not been examined and may aid in differentiating the disorders. METHOD: Analysis of responses of 24 pwE and 28 pwFDS in interviews exploring ictal experiences through open questioning followed by structured closed questioning using possible symptom prompts (74-item modified Psychosensory-Psychomotor Phenomena Interview, PPPI); self-report of psychological profile (HADS-A, HADS-D, PHQ-15, DES-T, THQ, PCL-C). RESULTS: Symptom prompting with PPPI elicited three times more seizure symptoms than open questions in pwE (median 34 vs. 11.5, p = 0.005) and over four times more in pwFDS (42.5 vs. 11, p = 0.001). Intra-ictal symptoms were reported freely more frequently by pwE (median 6.5 vs. 4, p = 0.005), while pwFDS reported more pre-ictal symptoms after prompts (median 6 vs 14.5, p = 0.004). The difference between freely reported and PPPI-elicited symptoms correlated with different psychopathological traits in pwE and pwFDS. Symptoms of anxiety (HADS-A) correlated more strongly with prompted symptoms among pwE than pwFDS (z = 2.731, p = 0.006). CONCLUSION: Prompting generates more detailed ictal symptom profiles than simply encouraging patients to narrate their subjective seizure experiences. While pwFDS freely reported fewer symptoms related to the intra-ictal period compared to pwE, pwFDS reported more pre-ictal symptoms than pwE when prompted. Differences in the psychopathological traits associated with the number of peri-ictal symptoms captured by symptom prompting in pwE and pwFDS possibly reflect etiological or psychological differences between these patient groups.

Comparing Companion Involvement in Clinical Telephone and Face-To-Face Consultations About Seizures.

Companions (i.e., friends, family members, and other accompanying persons) play an important role in seizure clinic consultations, providing information that patients cannot. The COVID-19 pandemic has seen an increase in these consultations being conducted via telephone. Little is known, however, about how this shift might affect companion participation. Using conversation analysis applied to a set of recorded telephone neurologist-patient-companion consultations (n = 9) and comparable moments drawn from a set of face-to-face consultations (n = 37) (both collected in the UK), we aimed to explore this impact and to identify communication methods that clinicians can use to manage companion participation during telephone consultations. We identified four ways in which participation was observably affected by the telephone. Telephone consultations could make it unclear whether a companion was present and make it difficult for the companion to communicate directly with the neurologist. Passing the floor from one speaker to another was more complex remotely, which could also restrict the patient's own participation once the companion had the floor. These issues are rooted in the limitations of the telephone as a communication medium. Based on the issues identified, we conclude our analysis by highlighting some of the ways in which neurologists and other health professionals can manage companion participation in telephone consultations. These include encouraging the use of speakerphone, checking whether a companion is present throughout the call, keeping track of who can hear what throughout the call, and directing questions using given names to avoid ambiguity.

A meta-analytic review of the effectiveness of psychological treatment of functional/dissociative seizures on non-seizure outcomes in adults.

Psychological therapies are considered the treatment of choice for functional/dissociative seizures (FDSs). Although most previous studies have focused on seizure persistence or frequency, it has been argued that well-being or health-related quality of life outcomes may actually be more meaningful. This study contributes by summarizing and meta-analyzing non-seizure outcomes to quantify the effectiveness of psychological treatment in this patient group. A pre-registered systematic search identified treatment studies (e.g., cohort studies, controlled trials) in FDSs. Data from these studies were synthesized using multi-variate random-effects meta-analysis. Moderators of treatment effect were examined using treatment characteristics, sample characteristics, and risk of bias. A total of 171 non-seizure outcomes across 32 studies with a pooled sample size of N = 898 yielded a pooled effect-size of d = .51 (moderate effect size). The outcome domain assessed and the type of psychological treatment were significant moderators of reported outcomes. Greater rates of improvement were demonstrated for outcomes assessing general functioning. Behavioral treatments emerged as particularly effective interventions. Psychological interventions are associated with clinical improvements across a broad array of non-seizure outcomes, over and above seizure frequency, in adults with FDSs.

Integrated psychological care services within seizure settings: Key components and implementation factors among example services in four ILAE regions: A report by the ILAE Psychiatry Commission.

Mental health comorbidities are prevalent and problematic in patients with seizures but often suboptimally managed. To address common gaps in care, the Integrated Mental Health Care Pathways Task Force of the International League Against Epilepsy (ILAE) Psychiatry Commission was tasked with providing education and guidance on the integration of mental health management (e.g., screening, referral, treatment) into routine seizure care. This report aims to describe a variety of established services in this area, with a specific focus on psychological care models. Services were identified by members of the ILAE Psychiatry Commission and authors of psychological intervention trials in epilepsy. A total of eight services met inclusion criteria and agreed to be showcased. They include three pediatric and five adult services located across four distinct ILAE regions (Europe, North America, Africa, Asia Oceania). The report describes the core operations, known outcomes, and implementation factors (i.e., barriers and facilitators) of these services. The report concludes with a set of practical tips for building successful psychological care services within seizure settings, including the importance of having local champions, clearly defining the scope of the service, and establishing sustainable funding models. The breadth of exemplars demonstrates how models tailored to the local environment and resources can be implemented. This report is an initial step to disseminate information regarding integrated mental health care within seizure care settings. Future work is needed to systematically examine both psychological and pharmacological care models and to further establish the evidence base in this area, especially around clinical impact, and cost-effectiveness.

Differentiating between epileptic and functional/dissociative seizures using semantic content analysis of transcripts of routine clinic consultations.

The common causes of Transient Loss of Consciousness (TLOC) are syncope, epilepsy, and functional/dissociative seizures (FDS). Simple, questionnaire-based decision-making tools for non-specialists who may have to deal with TLOC (such as clinicians working in primary or emergency care) reliably differentiate between patients who have experienced syncope and those who have had one or more seizures but are more limited in their ability to differentiate between epileptic seizures and FDS. Previous conversation analysis research has demonstrated that qualitative expert analysis of how people talk to clinicians about their seizures can help distinguish between these two TLOC causes. This paper investigates whether automated language analysis - using semantic categories measured by the Linguistic Inquiry and Word Count (LIWC) toolkit - can contribute to the distinction between epilepsy and FDS. Using patient-only talk manually transcribed from recordings of 58 routine doctor-patient clinic interactions, we compared the word frequencies for 21 semantic categories and explored the predictive performance of these categories using 5 different machine learning algorithms. Machine learning algorithms trained using the chosen semantic categories and leave-one-out cross-validation were able to predict the diagnosis with an accuracy of up to 81%. The results of this proof of principle study suggest that the analysis of semantic variables in seizure descriptions could improve clinical decision tools for patients presenting with TLOC.

Changes in Posttraumatic Stress Disorder Symptoms With Integrative Psychotherapy for Functional Neurological Symptom Disorder.

OBJECTIVE: Patients with functional neurological symptom disorder (FNSD) report high rates of traumatization and have high levels of posttraumatic stress disorder (PTSD) symptoms. Psychotherapy is a mainstay of treatment for persons with FNSD. In this study, the investigators explored changes in PTSD symptoms and health-related quality of life after psychotherapy among persons with FNSD and examined factors contributing to these changes. METHODS: Data were prospectively collected for patients with FNSD attending a specialist outpatient psychotherapy service in the United Kingdom (N=210) as part of an ongoing routine service evaluation. Pre- and posttherapy questionnaires included self-report measures of PTSD symptoms (Posttraumatic Stress Disorder Checklist-Civilian version), depressive symptoms (Patient Health Questionnaire-9), anxiety symptoms (General Anxiety Disorder-7 scale), somatic symptoms (Patient Health Questionnaire-15), health-related quality of life (Short-Form Health Survey-36), and social functioning (Work and Social Adjustment Scale). Independent contributions to psychotherapy-related changes in PTSD symptoms and health-related quality of life were explored through multivariate analyses. RESULTS: All outcome measures revealed improvements after psychotherapy (p<0.001). Psychotherapy-related changes in depression and somatic symptoms and employment status at baseline explained 51% of the variance in PTSD symptom changes. Changes in PTSD symptoms, depressive symptoms, and somatic symptoms made independent contributions to improvements in health-related quality of life (R2=0.54). Improvements were unrelated to FNSD subtype (dissociative seizures or other FNSD), age, marital status, or number of sessions attended. CONCLUSIONS: Reductions in self-reported PTSD, depressive, anxiety, and somatic symptoms, as well as improved health-related quality of life, were observed among patients who received one or more sessions of psychotherapy. Randomized controlled trials of psychotherapy for patients with FNSD are warranted.

COVID-19 and the Physio4FMD trial: Impact, mitigating strategies and analysis plans.

Introduction: Functional motor disorder (FMD) is a common cause of disabling neurological symptoms such as weakness and tremor. Physio4FMD is a pragmatic, multicentre single blind randomised controlled trial to evaluate effectiveness and cost effectiveness of specialist physiotherapy for FMD. Like many other studies this trial was affected by the COVID-19 pandemic. Methods: The planned statistical and health economics analyses for this trial are described, as well as the sensitivity analyses designed to assess the disruption caused by COVID-19. The trial treatment of at least 89 participants (33%) was disrupted due to the pandemic. To account for this, we have extended the trial to increase the sample size. We have identified four groups based on how participants' involvement in Physio4FMD was affected; A: 25 were unaffected; B: 134 received their trial treatment before the start of the COVID-19 pandemic and were followed up during the pandemic; C: 89 were recruited in early 2020 and had not received any randomised treatment before clinical services closed because of COVID-19; D: 88 participants were recruited after the trial was restarted in July 2021. The primary analysis will involve groups A, B and D. Regression analysis will be used to assess treatment effectiveness. We will conduct descriptive analyses for each of the groups identified and sensitivity regression analyses with participants from all groups, including group C, separately. Discussion: The COVID-19 mitigation strategy and analysis plans are designed to maintain the integrity of the trial while providing meaningful results. Trial registration: ISRCTN56136713.

Comparisons of Communication in Medical Face-To-Face and Teleconsultations: A Systematic Review and Narrative Synthesis.

The COVID-19 pandemic has brought telemedicine into mainstream medical practice (although questions remain over its role in a post-pandemic world). Research suggests that most patients and providers are satisfied with the flexibility and convenience of teleconsultations. However, there is continuing uncertainty about whether this shift has a clinically relevant impact on the quality of doctor-patient interaction. We conducted a systematic search of studies comparing communication in medical face-to-face consultations and teleconsultations. We included only studies which examined communication directly using recordings, excluding studies which used questionnaires or interviews. Studies were appraised using modified versions of the Critical Appraisal Skills Programme (CASP) checklists. Our search yielded 25,348 records, of which 22 were included in the final review. These studies were conducted in various medical specialties. Methodologies included approaches based on quantified communication behaviors using coding systems and qualitative studies using microanalytic methods. Except for duration (where there was evidence of face-to-face consultations being longer), no differences between the two modes of communication were consistently identified. In the aggregate, however, statistically significant differences were more prominent in primary care and more likely to favor face-to-face consultations. Qualitative studies also highlighted differences in how communication behaviors were manifested in each modality. Because much of the examined research was conducted in selected or non-routine settings, its applicability to the less selective use of telemedicine during and after the pandemic is limited.