Selective serotonin reuptake inhibitors (SSRIs) for stroke recovery.

BACKGROUND: Stroke is the major cause of adult disability. Selective serotonin reuptake inhibitors (SSRIs) have been used for many years to manage depression. Recently, small trials have demonstrated that SSRIs might improve recovery after stroke, even in people who are not depressed. Systematic reviews and meta-analyses are the least biased way to bring together data from several trials. Given the promising effect of SSRIs on stroke recovery seen in small trials, a systematic review and meta-analysis is needed. OBJECTIVES: To determine whether SSRIs improve recovery after stroke, and whether treatment with SSRIs was associated with adverse effects. SEARCH METHODS: We searched the Cochrane Stroke Group Trials Register (August 2011), Cochrane Depression Anxiety and Neurosis Group Trials Register (November 2011), Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 8), MEDLINE (from 1948 to August 2011), EMBASE (from 1980 to August 2011), CINAHL (from 1982 to August 2011), AMED (Allied and Complementary Medicine) (from 1985 to August 2011), PsycINFO (from 1967 to August 2011) and PsycBITE (Pyschological Database for Brain Impairment Treatment Efficacy) (March 2012). To identify further published, unpublished and ongoing trials we searched trials registers, pharmaceutical websites, reference lists, contacted experts and performed citation tracking of included studies. SELECTION CRITERIA: We included randomised controlled trials that recruited stroke survivors (ischaemic or haemorrhagic) at any time within the first year. The intervention was any SSRI, given at any dose, for any period. We excluded drugs with mixed pharmacological effects. The comparator was usual care or placebo. In order to be included, trials had to collect data on at least one of our primary (dependence and disability) or secondary (impairments, depression, anxiety, quality of life, fatigue, healthcare cost, death, adverse events and leaving the trial early) outcomes. DATA COLLECTION AND ANALYSIS: We extracted data on demographics, type of stroke, time since stroke, our primary and secondary outcomes, and sources of bias. For trials in English, two review authors independently extracted data. For Chinese papers, one review author extracted data. We used standardised mean differences (SMD) to estimate treatment effects for continuous variables, and risk ratios (RR) for dichotomous effects, with their 95% confidence intervals (CIs). MAIN RESULTS: We identified 56 completed trials of SSRI versus control, of which 52 trials (4059 participants) provided data for meta-analysis. There were statistically significant benefits of SSRI on both of the primary outcomes: RR for reducing dependency at the end of treatment was 0.81 (95% CI 0.68 to 0.97) based on one trial, and for disability score, the SMD was 0.91 (95% CI 0.60 to 1.22) (22 trials involving 1343 participants) with high heterogeneity between trials (I(2) = 87%; P < 0.0001). For neurological deficit, depression and anxiety, there were statistically significant benefits of SSRIs. For neurological deficit score, the SMD was -1.00 (95% CI -1.26 to -0.75) (29 trials involving 2011 participants) with high heterogeneity between trials (I(2) = 86%; P < 0.00001). For dichotomous depression scores, the RR was 0.43 (95% CI 0.24 to 0.77) (eight trials involving 771 participants) with high heterogeneity between trials (I(2) = 77%; P < 0.0001). For continuous depression scores, the SMD was -1.91 (95% CI -2.34 to -1.48) (39 trials involving 2728 participants) with high heterogeneity between trials (I(2) = 95%; P < 0.00001). For anxiety, the SMD was -0.77 (95% CI -1.52 to -0.02) (eight trials involving 413 participants) with high heterogeneity between trials (I(2) = 92%; P < 0.00001). There was no statistically significant benefit of SSRI on cognition, death, motor deficits and leaving the trial early. For cognition, the SMD was 0.32 (95% CI -0.23 to 0.86), (seven trials involving 425 participants) with high heterogeneity between trials (I(2) = 86%; P < 0.00001). The RR for death was 0.76 (95% CI 0.34 to 1.70) (46 trials involving 3344 participants) with no heterogeneity between trials (I(2) = 0%; P = 0.85). For motor deficits, the SMD was -0.33 (95% CI -1.22 to 0.56) (two trials involving 145 participants). The RR for leaving the trial early was 1.02 (95% CI 0.86 to 1.21) in favour of control, with no heterogeneity between trials. There was a non-significant excess of seizures (RR 2.67; 95% CI 0.61 to 11.63) (seven trials involving 444 participants), a non-significant excess of gastrointestinal side effects (RR 1.90; 95% CI 0.94 to 3.85) (14 trials involving 902 participants) and a non-significant excess of bleeding (RR 1.63; 95% CI 0.20 to 13.05) (two trials involving 249 participants) in those allocated SSRIs. Data were not available on quality of life, fatigue or healthcare costs.There was no clear evidence from subgroup analyses that one SSRI was consistently superior to another, or that time since stroke or depression at baseline had a major influence on effect sizes. Sensitivity analyses suggested that effect sizes were smaller when we excluded trials at high or unclear risk of bias.Only eight trials provided data on outcomes after treatment had been completed; the effect sizes were generally in favour of SSRIs but CIs were wide. AUTHORS' CONCLUSIONS: SSRIs appeared to improve dependence, disability, neurological impairment, anxiety and depression after stroke, but there was heterogeneity between trials and methodological limitations in a substantial proportion of the trials. Large, well-designed trials are now needed to determine whether SSRIs should be given routinely to patients with stroke

Electronic health records to facilitate clinical research

Electronic health records (EHRs) provide opportunities to enhance patient care, embed performance measures in clinical practice, and facilitate clinical research. Concerns have been raised about the increasing recruitment challenges in trials, burdensome and obtrusive data collection, and uncertain generalizability of the results. Leveraging electronic health records to counterbalance these trends is an area of intense interest. The initial applications of electronic health records, as the primary data source is envisioned for observational studies, embedded pragmatic or post-marketing registry-based randomized studies, or comparative effectiveness studies. Advancing this approach to randomized clinical trials, electronic health records may potentially be used to assess study feasibility, to facilitate patient recruitment, and streamline data collection at baseline and follow-up. Ensuring data security and privacy, overcoming the challenges associated with linking diverse systems and maintaining infrastructure for repeat use of high quality data, are some of the challenges associated with using electronic health records in clinical research. Collaboration between academia, industry, regulatory bodies, policy makers, patients, and electronic health record vendors is critical for the greater use of electronic health records in clinical research. This manuscript identifies the key steps required to advance the role of electronic health records in cardiovascular clinical research

Interventions for treating anxiety after stroke

Background: Approximately 20% of stroke patients experience anxiety at some point after stroke. Objectives: To determine if any treatment for anxiety after stroke decreases the proportion of patients with anxiety disorders or symptoms, and to determine the effect of treatment on quality of life, disability, depression, social participation, risk of death or caregiver burden. Search methods: We searched the trials register of the Cochrane Stroke Group (October 2010), CENTRAL (The Cochrane Library 2010, Issue 4), MEDLINE (1950 to October 2010), EMBASE (1947 to October 2010), PsycINFO (1806 to October 2010), Allied and Complementary Medicine database (AMED) (1985 to October 2010), Cumulative Index to Nursing and Allied Health (CINAHL) (1982 to October 2010), Proquest Digital Dissertations (1861 to October 2010), and Psychological Database for Brain Impairment Treatment Efficacy (PsycBITE) (2004 to October 2010). In an effort to identify further published, unpublished and ongoing trials, we searched trial registries and major international stroke conference proceedings, scanned reference lists, and contacted select individuals known to the review team who are actively involved in psychological aspects of stroke research, and the Association of the British Pharmaceutical Industry. Selection criteria: Two review authors independently screened and selected titles and abstracts for inclusion in the review. Randomised trials of any intervention in patients with stroke where the treatment of anxiety was an outcome were eligible. Data collection and analysis: Two review authors independently extracted data for analysis. We performed a narrative review. A meta-analysis was planned but not carried out as studies were not of sufficient quality to warrant doing so. Main results: We included two trials (three interventions) involving 175 participants with co-morbid anxiety and depression in the review. Both trials used the Hamilton Anxiety Scale (HAM-A) to assess anxiety, and neither included a placebo control group. One trial randomised 81 patients to paroxetine, paroxetine plus psychotherapy or standard care. Mean level of anxiety severity scores were 58% and 71% lower in the paroxetine, and paroxetine plus psychotherapy groups respectively compared with those in standard care at follow-up (P < 0.01). The second trial randomised 94 stroke patients, also with co-morbid anxiety and depression, to receive buspirone hydrochloride or standard care. At follow-up, the mean level of anxiety was significantly lower for those receiving buspirone relative to controls (P < 0.01). Half of the participants receiving paroxetine experienced adverse events that included nausea, vomiting or dizziness; however, only 14% of those receiving buspirone experienced nausea or palpitations. No information was provided about the duration of symptoms associated with adverse events. Authors' conclusions: There is insufficient evidence to guide the treatment of anxiety after stroke. The data available suggest that pharmaceutical therapy (paroxetine and buspirone) may be effective in reducing anxiety symptoms in stroke patients with co-morbid anxiety and depression. No information was available for stroke patients with anxiety only. Randomised placebo controlled trials are needed

Effects of Supervised Multimodal Exercise Interventions on Cancer-Related Fatigue: Systematic Review and Meta-Analysis of Randomized Controlled Trials

Objective. Cancer-related fatigue (CRF) is the most common and devastating problem in cancer patients even after successful treatment. This study aimed to determine the effects of supervised multimodal exercise interventions on cancer-related fatigue through a systematic review and meta-analysis. Design. A systematic review was conducted to determine the effectiveness of multimodal exercise interventions on CRF. Databases of PubMed, CENTRAL, EMBASE, and OVID were searched between January and March 2014 to retrieve randomized controlled trials. Risk of bias was evaluated using the PEDro scale. Results. Nine studies (n=772) were included in both systematic review and meta-analysis. Multimodal interventions including aerobic exercise, resistance training, and stretching improved CRF symptoms (SMD=-0,23; 95% CI: −0.37 to −0.09; P=0,001). These effects were also significant in patients undergoing chemotherapy (P<0,0001). Nonsignificant differences were found for resistance training interventions (P=0,30). Slight evidence of publication bias was observed (P=0,04). The studies had a low risk of bias (PEDro scale mean score of 6.4 (standard deviation (SD) ± 1.0)). Conclusion. Supervised multimodal exercise interventions including aerobic, resistance, and stretching exercises are effective in controlling CRF. These findings suggest that these exercise protocols should be included as a crucial part of the rehabilitation programs for cancer survivors and patients during anticancer treatments.This paper and own authors data described in this paper were supported by the grant from Vicerrectoría de Investigaciones, Universidad de Santo Tomás (Contract no. 617-3-2013)

Content comparison of patient-reported outcome instruments used to measure burnout

The aim of this article is to compare the content of patient-reported outcome (PRO) burnout measures and to examine the degree of overlap between them and psychosocial difficulties (PSD) experienced by persons with burnout. The most frequently used PRO and qualitative studies were identified in two systematic literature reviews. Psychosocial difficulties identified in both sources were standardized and a qualitative content comparison was performed. Seven PROs and seven qualitative studies were selected. Energy and drive, emotional functions and work were key themes of both sources. Disparities were observed for problems in areas such as sleep, attention or family relationships, which were reported in several qualitative studies, but are seldom addressed in PROs. Several areas important to persons with burnout, such as family relationships, are seldom measured by currently used PROs. From a biopsychosocial perspective, these instruments cannot therefore be considered comprehensive enough to capture the whole experience of burnout and should be improved.<br/

Lateral Alveolar Ridge Augmentation with Autogenous Tooth Block Graft Compared with Autogenous Bone Block Graft:a Systematic Review

OBJECTIVES: The objective of the present systematic review was to evaluate the current knowledge of implant treatment outcome following lateral alveolar ridge augmentation with autogenous tooth block graft compared with autogenous bone block graft prior to implant placement. MATERIAL AND METHODS: MEDLINE (PubMed), Embase and Cochrane Library search in combination with hand-search of relevant journals was conducted including human studies published in English through December 20, 2021. Comparative and non-comparative studies assessing lateral alveolar ridge augmentation with autogenous tooth block graft were included. Quality and risk-of-bias assessment were evaluated by Cochrane risk of bias tool, Newcastle-Ottawa Scale and GRADE system. RESULTS: One comparative study characterized by low grade and two non-comparative studies fulfilled the inclusion criteria. No significant difference in short-term implant survival, health status of the peri-implant tissue or frequency of complications between the two treatment modalities was observed. Postoperative dimensional changes of the alveolar ridge width were significant diminished with tooth block compared with bone block (P = 0.0029). Consequently, the gain in alveolar ridge width was significantly higher with tooth block, after 26 weeks (P = 0.014). However, a higher frequency of short-term peri-implant mucositis was observed with tooth block. CONCLUSIONS: Lateral alveolar ridge augmentation with tooth block seems to be a suitable alternative to bone block. However, results of the present systematic review are based on short-term studies involving small patient samples. Further long-term randomized controlled trials are therefore needed before definite conclusions can be provided about the beneficial use of tooth block compared with bone block

Rehabilitation for improving automobile driving after stroke

Publisher version made available in accordance with the publisher's policy. This item is under embargo for a period of 12 months from the date of publication, in accordance with the publisher's policy. 'This review is published as a Cochrane Review in the Cochrane Database of Systematic Reviews 2014, Issue 2. Cochrane Reviews are regularly updated as new evidence emerges and in response to comments and criticisms, and the Cochrane Database of Systematic Reviews should be consulted for the most recent version of the Review.’Background Interventions to improve driving ability after stroke, incl uding driving simulation and retraining visual skills, hav e limited evaluation of their effectiveness to guide policy and practice. Objectives To determine whether any intervention, with the specific aim o f maximising driving skills, improves the driving performa nce of people after stroke. Search methods WesearchedtheCochrane Stroke GroupTrialsregister(August 2 013), theCochrane Central Registerof ControlledTrials( The Cochrane Library 2012, Issue 3), MEDLINE (1950 to October 2013), EMBASE (1980 to Octo ber 2013), and six additional databases. To identify further published, unpublished and ongoing trial s, we handsearched relevant journals and conference proceeding s, searched trials and research registers, checked reference lists and conta cted key researchers in the area. Selection criteria Randomised controlled trials (RCTs), quasi-randomised trials and cluster studies of rehabilitation interventions, with t he specific aim of maximising driving skills or with an outcome of assessing d riving skills in adults after stroke. The primary outcome of i nterest was the performance in an on-road assessment after training. Secon dary outcomes included assessments of vision, cognition and dr iving behaviour. Data collection and analysis Two review authors independently selected trials based on pr e-defined inclusion criteria, extracted the data and assessed ri sk of bias. A third review author moderated disagreements as required. T he review authors contacted all investigators to obtain missi ng information. Main results We included four trials involving 245 participants in the revi ew. Study sample sizes were generally small, and interventi ons, controls and outcome measures varied, and thus it was inappropriate to pool studies. Included studies were at a low risk of bias for th e majority of domains, with a high/unclear risk of bias identified in the a reas of: performance (participants not blinded to allocation), a nd attrition (incomplete outcome data due to withdrawal) bias. Interventio n approaches included the contextual approach of driving simula tion and underlying skill development approach, including the ret raining of speed of visual processing and visual motor skills . The studies were conducted with people who were relatively young and the ti ming after stroke was varied. Primary outcome: there was no cle ar evidence of improved on-road scores immediately after trainin g in any of the four studies, or at six months (mean difference 15 points on the Test Ride for Investigating Practical Fitness to Drive - Belgian version, 95% confidence intervals (CI) 4.56 to 34.56, P v alue = 0.15, one study, 83 participants). Secondary outcomes: road sig n recognition was better in people who underwent training comp ared with control (mean difference 1.69 points on the Road Sign Recogn ition Task of the Stroke Driver Screening Assessment, 95% CI 0 .51 to 2.87, P value = 0.007, one study, 73 participants). Significan t findings were in favour of a simulator-based driving rehabil itation programme (based on one study with 73 participants) but these r esults should be interpreted with caution as they were based o n a single study. Adverse effects were not reported. There was insufficie nt evidence to draw conclusions on the effects on vision, other me asures of cognition, motor and functional activities, and driving beh aviour with the intervention. Authors’ conclusions There was insufficient evidence to reach conclusions about the use of rehabilitation to improve on-road driving skills after st roke. We found limited evidence that the use of a driving simulator m ay be beneficial in improving visuocognitive abilities, such as road sign recognition that are related to driving. Moreover, we we re unable to find any RCTs that evaluated on-road driving lesso ns as an intervention. At present, it is unclear which impairments tha t influence driving ability after stroke are amenable to rehab ilitation, and whether the contextual or remedial approaches, or a combinatio n of both, are more efficacious