Pharmaceutical interventions for emotionalism after stroke [update]

Copyright © 2019 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Background Antidepressants may be useful in the treatment of abnormal crying associated with stroke. This is an update of a Cochrane Review first published in 2004 and last updated in 2010. Objectives To determine whether pharmaceutical treatment reduces the frequency of emotional displays in people with emotionalism after stroke. Search methods We searched the trial register of Cochrane Stroke (last searchedMay 2018). In addition, we searched the Cochrane Central Register of Controlled Trials (CENTRAL; to May 2018), MEDLINE (1966 to 14 May 2018), Embase (1980 to 14 May 2018), CINAHL (1982 to 14 May 2018), PsycINFO (1967 to 14 May 2018), BIOSIS Previews (2002 to 14 May 2018), Web of Science (2002 to 14 May 2018), WHO ICTRP (to 14 May 2018), ClinicalTrials.gov (to 14 May 2018), and ProQuest Dissertations and Theses Database (to 14 May 2018). Selection criteria Randomised controlled trials (RCTs) and quasi-RCTs comparing psychotropic medication to placebo in people with stroke and emotionalism (also known as emotional lability, pathological crying or laughing, emotional incontinence, involuntary emotional expression disorder, and pseudobulbar affect). Data collection and analysis Two review authors independently selected studies, assessed risk of bias, extracted data from all included studies, and used GRADE to assess the quality of the body of evidence.We calculated mean difference (MD) or standardised mean difference (SMD) for continuous data and risk ratio (RR) for dichotomous data with 95% confidence intervals (CIs). We assessed heterogeneity using the I2 statistic. The primary emotionalism measures were the proportion of participants achieving at least a 50% reduction in abnormal emotional behaviour at the end of treatment, improved score on Center for Neurologic Study-Lability Scale (CNS-LS), Clinician Interview-Based Impression of Change (CIBIC) or diminished tearfulness. Main results We included seven trials with a total of 239 participants. Two trials were of cross-over design, and outcome data were not available from the first phase (precross-over) in an appropriate format for inclusion as a parallel randomised controlled trial (RCT). Thus, the results of the review are based on five trials with 213 participants. Treatment effects were observed on the following primary endpoints of emotionalism: There is very low quality of evidence from one small RCT that antidepressants increased the number of people who had 50% reduction in emotionalism (RR 16.50, 95% CI 1.07 to 253.40; 19 participants) and low quality evidence from one RCT of improved scores on Center for Neurologic Study-Lability Scale (CNS-LS) and Clinician Interview-Based Impression of Change (CIBIC) with antidepressants (RR 1.44, 95% CI 0.95 to 2.19; 28 participants). There was moderate quality evidence from three RCTS that they increased the number of people who had a reduction in tearfulness (RR 2.18, 95% CI 1.29 to 3.71; 164 participants); and low quality evidence from one RCT of improved scores on the Pathological Laughter and Crying Scale (PLCS) (MD 8.40, 95% CI 11.56 to 5.24; 28 participants). Six trials reported adverse events (death) and found no difference between the groups in death (RR 0.59, 95%CI 0.08 to 4.50; 6 RCTs, 172 participants, moderate-quality evidence). Authors' conclusions Antidepressantsmay reduce the frequency and severity of crying or laughing episodes based on very lowquality evidence.Our conclusions must be qualified by several methodological deficiencies in the studies and interpreted with caution despite the effect being very large. The effect does not seem specific to one drug or class of drugs. More reliable data are required before appropriate conclusions can be made about the treatment of post-stroke emotionalism. Future trialists investigating the effect of antidepressants in people with emotionalism after stroke should consider developing and using a standardised method to diagnose emotionalism, determine severity and assess change over time; provide treatment for a sufficient duration and follow-up to better assess rates of relapse or maintenance and include careful assessment and complete reporting of adverse events

Systematic Review and Meta-Analysis of Psychosocial Risk Factors for Stroke

Background Several studies have assessed the link between psychosocial risk factors and stroke; however, the results are inconsistent. We have conducted a systemic review and meta-analysis of cohort or case-control studies to ascertain the association between psychosocial risk factors (psychological, vocational, behavioral, interpersonal and neuropsychological) and the risk of stroke. Methods Systematic searches were undertaken in MEDLINE, EMBASE, CINAHL, PsycInfo and the Cochrane Database of Systematic Reviews between 2000 and January 2017. Two reviewers independently screened titles, abstracts and full texts. One reviewer assessed quality and extracted data, which was checked by a second reviewer. For studies that reported risk estimates, a meta-analysis was performed. Results We identified 41 cohort studies and five case-control studies. No neuropsychological papers were found. Overall pooled adjusted estimates showed that all other psychosocial risk factors were independent risk factors for stroke. Psychological factors increased the risk of stroke by 39% (HR 1.39 95% CI:1.27;1.51), vocational by 35% (HR 1.35 95% CI: 1.20;1.51), and interpersonal by 16% (HR 1.16 95% CI:1.03;1.31). and the effects of behavioral factors were equivocal (HR 0.94 95% CI: 0.20;4.31). The meta-analyses were affected by heterogeneity. Conclusions Psychosocial risk factors are associated with an increased risk of strok

Motivational Interviewing Post-Stroke: An Analysis of Stroke Survivors' Concerns and Adjustment

Our earlier research demonstrated that participation in four sessions of motivational interviewing (MI) early post-stroke has a positive impact on stroke survivors' mood. However, the theoretical underpinnings of MI in supporting adjustment (rather than its traditional use in supporting behavior change) require clarification. This article describes a content analysis of MI transcripts for 10 participants in our previous study, to identify the focus of discussions (patient "concerns") and potential effective components of our MI approach. Patients' post-stroke concerns were shown in 16 categories, including frustration, family impact, and getting well. There was a pattern of change discourse across sessions: "Sustain talk" (reasons for not changing) reduced from Session 1 onward, "change talk" (intent to change) increased then reduced, and "change expressed" (changes achieved) increased from Sessions 1 to 4. MI facilitates healthy adjustment post-stroke in some patients, in turn affecting mood, but clarification of how this effect is achieved requires further exploration

Delivering motivational interviewing early post stroke: standardisation of the intervention

Background We applied Motivational Interviewing (MI) techniques, early after stroke, to facilitate psychological adjustment to life post-stroke. In our trial, MI-plus-usual-care increased the likelihood of normal mood at 3-months post-stroke, compared to usual-care alone. Whilst appropriate training, manuals, and supervision may increase adherence to core principles of this complex intervention, unintended variability in implementation inevitably remains. We aimed to explore the impact of variability on participant outcome. Methods Using our trial data (411 participants), we explored variation in MI delivery, examining: therapist characteristics (stroke care expertise/knowledge, psychology training); MI content (fidelity to MI techniques assessed with Motivational Interviewing Treatment Integrity code, describing therapist behaviours as MI-consistent, MI-neutral or MI-inconsistent); and MI dose (number/duration of sessions). Results The four MI therapists (two nurses/two psychologists) had varying expertise and MI delivery. Across therapists, mean average session duration ranged 29.5–47.8 min. The percentage of participants completing the per-protocol four sessions ranged 47%–74%. These variations were not related to participant outcome. There were uniformly high frequencies (>99%) of MI-consistent and MI-neutral interactions, and low frequencies (<1%) of MI-inconsistent interactions. Conclusions Variation in therapist characteristics and MI dose did not affect participant outcome. These may have been tolerated due to high fidelity to MI principles

Stroke in India: a systematic review of the incidence, prevalence and case fatality

Background: The burden of stroke is increasing in India; stroke is now the fourth leading cause of death and the fifth leading cause of disability. Previous research suggests that the incidence of stroke in India ranges between 105 and 152/100,000 people per year. However, there is a paucity of available data and a lack of uniform methods across published studies. Aim: To identify high-quality prospective studies reporting the epidemiology of stroke in India. Summary of review: A search strategy was modified from the Cochrane Stroke Strategy and adapted for a range of bibliographic databases from January 1997 to August 2020. From 7,717 identified records, nine studies were selected for inclusion; three population-based registries, a further three population-based registries also using community-based ascertainment and three community-based door-to-door surveys. Studies represented the four cities of Mumbai, Trivandrum, Ludhiana, Kolkata, the state of Punjab and 12 villages of Baruipur in the state of West Bengal. The total population denominator was 22,479,509 and 11,654 (mean 1,294 SD 1,710) people were identified with incident stroke. Crude incidence of stroke ranged from 108 to 172/100,000 people per year, crude prevalence from 26 to 757/100,000 people per year and one-month case fatality rates from 18% to 42%. Conclusions: Further high-quality evidence is needed across India to guide stroke policy and inform the development and organisation of stroke services. Future researchers should consider the World Health Organisation STEPwise approach to Surveillance (STEPS) framework, including longitudinal data collection, the inclusion of census population data and a combination of hospital-registry and comprehensive community ascertainment strategies to ensure complete stroke identification

Parallel-Serial Memoing: A Novel Approach to Analyzing Qualitative Data

The mechanisms by which talking therapies exert their beneficial effects are largely unknown. In exploring the process of a talking therapy, motivational interviewing (MI), when used to treat and prevent low mood in stroke survivors, we developed, what we believe to be, a novel approach to analyzing transcripts. We illustrate the method using qualitative data from MI sessions with 10 stroke survivors. The approach, drawing on grounded theory, incorporated processes of parallel and serial memoing among a team of researchers to allow a process of validation. This enabled us to describe session content and to develop theoretical interpretations of what was occurring in and across MI sessions. We found that this process can be used to integrate different perspectives in theory building, allowing for a richer description and more robust theoretical interpretation. Others can use and adapt this approach to develop insights into their own inquiry

A mixed methods study exploring inter-professional roles in the provision of UK outpatient TIA Services

Background: Suspected transient ischaemic attack (TIA) is a diagnostic challenge yet requires timely diagnosis for secondary stroke prevention. Aims: To understand variability of organisational processes, roles, education, and clinical decision-making in UK TIA services. Methods: Healthcare professionals were surveyed online in 2021 with descriptive data analysis. We conducted interviews (2021-2022) with a purposive sample. Three researchers thematically analysed interview data. Findings: Survey responses were received from 43 TIA services. 70% conducted remote consultations, 28% face-to-face, and 2% mixed. Different physician and roles, skills and experience provided TIA services. All services involved a consultant physician with experience in stroke. Ten interviews confirmed the survey results and highlighted variability regarding: clinical decision-making; service composition; resources; learning opportunities; and mode of consultation. Conclusion: Variability in TIA service workforce and service organisation influenced diagnostic decisions. The possible impact of such variability on clinical outcomes, and approaches to reducing it, require further research

(Review) Pharmacological, psychological, and non-invasive brain stimulation interventions for treating depression after stroke

Background Depression is an important morbidity associated with stroke that impacts on recovery yet is often undetected or inadequately treated. Objectives To evaluate the benefits and harms of pharmacological intervention, non-invasive brain stimulation, psychological therapy, or combinations of these to treat depression after stroke. Search methods This is a living systematic review. We search for new evidence every two months and update the review when we identify relevant new evidence. Please refer to the Cochrane Database of Systematic Reviews for the current status of this review. We searched the Specialised Registers of Cochrane Stroke, and Cochrane Depression Anxiety and Neurosis, CENTRAL, MEDLINE, Embase, five other databases, two clinical trials registers, reference lists and conference proceedings (February 2022). We contacted study authors. Selection criteria Randomised controlled trials comparing (1) pharmacological interventions with placebo; (2) non-invasive brain stimulation with sham stimulation or usual care; (3) psychological therapy with usual care or attention control; (4) pharmacological intervention and psychological therapy with pharmacological intervention and usual care or attention control; (5) pharmacological intervention and noninvasive brain stimulation with pharmacological intervention and sham stimulation or usual care; (6) pharmacological intervention and psychological therapy with placebo and psychological therapy; (7) pharmacological intervention and non-invasive brain stimulation with placebo plus non-invasive brain stimulation; (8) non-invasive brain stimulation and psychological therapy versus non-invasive brain stimulation plus usual care or attention control; and (9) non-invasive brain stimulation and psychological therapy versus sham brain stimulation or usual care plus psychological therapy, with the intention of treating depression after stroke. Data collection and analysis Two authors independently selected studies, assessed risk of bias, and extracted data from included studies. We calculated mean difference (MD) or standardised mean difference (SMD) for continuous data, and risk ratio (RR) for dichotomous data, with 95% confidence intervals (CIs). We assessed heterogeneity using the I² statistic and certainty of the evidence according to GRADE. Main results We included 65 trials (72 comparisons) with 5831 participants. Data were available for (1) 20 comparisons; (2) 9 comparisons; (3) 25 comparisons; (4) 3 comparisons; (5) 14 comparisons; and (6) 1 comparison. We found no trials for comparisons 7 to 9. Comparison 1- Pharmacological interventions: Very low-certainty evidence from eight trials suggest pharmacological interventions decreased the number of people meeting the study criteria for depression (RR 0.70, 95% CI 0.55 to 0.88; p= 0.002; 8 RCTs; 1025 participants) at end of treatment and very low-certainty evidence from six trials suggest that pharmacological interventions decreased the number of people with inadequate response to treatment(RR 0.47, 95% CI 0.32 to 0.70; p= 0.0002; 6 RCTs; 511 participants) compared to placebo. More adverse events related to the central nervous system (CNS; RR 1.55, 95% CI 1.12 to 2.15; p=0.008; 5 RCTs; 488 participants; very low-certainty evidence) and gastrointestinal system (RR 1.62, 95% CI 1.19 to 2.19; p= 0.002; 4 RCTs; 473 participants; very low-certainty evidence) were noted in the pharmacological intervention than in the placebo group. Comparison 2- Non-invasive brain stimulation: Very-low certainty evidence from two trials show that non-invasive brain stimulation had little to no effect on the number of people meeting the study criteria for depression (RR 0.67, 95% CI 0.39 to 1.14; p= 0.14; 2 RCTs; 130 participants) and the number of people with inadequate response to treatment (RR 0.84, 95% CI 0.52, 1.37; p= 0.49; 2 RCTs; 130 participants) compared to sham stimulation. Non-invasive brain stimulation resulted in no deaths. Comparison 3- Psychological therapy: Very low-certainty evidence from six trials suggest that psychological therapy decreased the number of people meeting the study criteria for depression at end of treatment (RR 0.77, 95% CI 0.62 to 0.95; p= 0.01; 521 participants) compared to usual care/attention control. No trials of psychological therapy reported on the outcome inadequate response to treatment. No differences in the number of deaths or adverse events were found in the psychological therapy group compared to the usual care/attention control group. Comparison 4- Pharmacological interventions with psychological therapy: No trials of this combination reported on the primary outcomes. Combination therapy resulted in no deaths. Comparison 5- Pharmacological interventions with non-invasive brain stimulation: Non-invasive brain stimulation with pharmacological intervention reduced the number of people meeting study criteria for depression at end of treatment (RR 0.77, 95% CI 0.64 to 0.91; p= 0.002; 3 RCTs; 392 participants; low certainty evidence) but not the number of people with inadequate response to treatment (RR 0.95, 95% CI 0.69 to 1.30; p= 0.75; 3 RCTs; 392 participants; very-low certainty evidence) compared to pharmacological therapy alone. Very-low certainty evidence from five trials suggest no difference in deaths between this combination therapy (RR 1.06, 95% CI 0.27 to 4.16; p= 0.93; 487 participants) compared to pharmacological therapy intervention and sham stimulation or usual care. Comparison 6- Non-invasive brain stimulation with psychological therapy: No trials of this combination reported on the primary outcomes