Implementation and feasibility of the stroke nursing guideline in the care of patients with stroke: a mixed methods study

Background

Nurses often have difficulties with using interdisciplinary stroke guidelines for patients with stroke as they do not focus sufficiently on nursing. Therefore, the Stroke Nursing Guideline (SNG) was developed and implemented. The aim of this study was to determine the implementation and feasibility of the SNG in terms of changes in documentation and use of the guideline in the care of stroke patients on Neurological and Rehabilitation wards, barriers and facilitators, and nurses’ and auxiliary nurses’ view of the implementation.

Methods

A sequential explorative mixed method design was used including pre-test post-test measures and post intervention focus groups interviews. For the quantitative part retrospective electronic record data of nursing care was collected from 78 patients and prospective measures with Barriers and Facilitators Assessment Instrument (BFAI) and Quality Indicator Tool (QIT) from 33 nursing staff including nurses and auxiliary nurses. In the qualitative part focus groups interviews were conducted with nursing staff on usefulness of the SNG and experiences with implementation.

Results

Improved nursing documentation was found for 23 items (N?=?37), which was significant for nine items focusing mobility (p?=?0.002, p?=?0.024, p?=?0.012), pain (p?=?0.012), patient teaching (p?=?0.001, p?=?0.000) and discharge planning (p?=?0.000, p?=?0.002, p?=?0.004). Improved guideline use was found for 20 QIT-items (N?=?30), with significant improvement on six items focusing on mobility (p?=?0.023), depression (p?=?0.033, p?=?0.025, p?=?0.046, p?=?0.046), discharge planning (p?=?0.012). Facilitating characteristics for change were significantly less for two of four BFAI-subscales, namely Innovation (p?=?0.019) and Context (p?=?0.001), whereas no change was found for Professional and Patient subscales. The findings of the focus group interviews showed the SNG to be useful, improving and providing consistency in care. The implementation process was found to be successful as essential components of nursing rehabilitation were defined and integrated into daily care.

Conclusion

Nursing staff found the SNG feasible and implementation successful. The SNG improved nursing care, with increased consistency and more rigorous functional exercises than before. The SNG provides nurses and auxiliary nurses with an important means for evidence based care for patients with stroke. Several challenges of implementing this complex nursing intervention surfaced which mandates ongoing attention.

     

Assessment of right ventricular longitudinal strain by 2D speckle tracking imaging compared with RV function and hemodynamics in pulmonary hypertension

The right ventricular longitudinal strain (RVLS) of pulmonary hypertension (PH) patients and its relationship with RV function parameters measured by echocardiography and hemodynamic parameters measured by right heart catheterization was investigated. According to the WHO functional class (FC), 66 PH patients were divided into FC I/II (group 1) and III/IV (group 2). RV function parameters were measured by echocardiographic examinations. Hemodynamic parameters were obtained by right heart catheterization. Patients in group 2 had higher systolic pulmonary artery pressure (sPAP; P?<?0.05) than patients in group (1) significant between-group differences were observed in global RVLS (RVLS_global), free wall RVLS (RVLS_FW; P?<?0.01), and RV conventional function parameters (all P?<?0.05). Moreover, mPAP and PVR increased remarkably and CI decreased significantly in group (2) RVLS_global had a positive correlation with 6-min walking distance (6MWD; r?=?0.492, P?<?0.001) and N-terminal pro-brain natriuretic peptide (NT-proBNP; r?=?0.632, P?<?0.001), while RVLS_FW had a positive correlation with 6MWD (r?=?0.483, P?<?0.001) and NT-proBNP (r?=?0.627, P?<?0.001). Hemodynamics analysis revealed that RVLS_global had a positive correlation with mPAP (r?=?0.594, P?<?0.001), PVR (r?=?0.573, P?<?0.001) and CI (r?=?0.366, P?=?0.003), while RVLS_FW had a positive correlation with mPAP (r?=?0.597, P?<?0.001), PVR (r?=?0.577, P?<?0.001) and CI (r?=?0.369, P?=?0.002). According to receiver operating characteristic curves, the optimal cut-off values of RVLS_global (–15.0%) and RVLS_FW (–15.3%) for prognosis detection with good sensitivity and specificity. Evidence has shown that RVLS measurement can provide the much-needed and reliable information on RV function and hemodynamics. Therefore, this qualifies as a patient-friendly approach for the clinical management of PH patients.     

Effects of a self-managed home-based walking intervention on psychosocial health outcomes for breast cancer patients receiving chemotherapy: a randomised controlled trial

Purpose

This study evaluated the effectiveness of a self-managed home-based moderate intensity walking intervention on psychosocial health outcomes among breast cancer patients undergoing chemotherapy.

Methods

The randomised controlled trial compared a self-managed, home-based walking intervention to usual care alone among breast cancer patients receiving chemotherapy. Outcome measures included changes in self-report measures of anxiety, depression, fatigue, self-esteem, mood and physical activity. Fifty participants were randomised to either the intervention group (n?=?25), who received 12 weeks of moderate intensity walking, or the control group (n?=?25) mid-way through chemotherapy. Participants in the intervention group were provided with a pedometer and were asked to set goals and keep weekly diaries outlining the duration, intensity and exertion of their walking. Levels of psychosocial functioning and physical activity were assessed pre- and post-intervention in both groups.

Results

The intervention had positive effects on fatigue (F?=?5.77, p?=?0.02), self-esteem (F?=?8.93, p?≤?0.001), mood (F?=?4.73, p?=?0.03) and levels of physical activity (x ²?=?17.15, p?=?0.0011) but not anxiety (F?=?0.90, p?=?0.35) and depression (F?=?0.26, p?=?0.60) as assessed using the HADS. We found an 80 % adherence rate to completing the 12-week intervention and recording weekly logs.

Conclusion

This self-managed, home-based intervention was beneficial for improving psychosocial well-being and levels of physical activity among breast cancer patients treated with chemotherapy.

Trial registration

Current Controlled Trials ISRCTN50709297.

     

Implicit Measures of Actual Versus Ideal Body Image: Relations with Self-Reported Body Dissatisfaction and Dieting Behaviors

Body dissatisfaction refers to a negative appreciation of one’s own body stemming from a discrepancy between how one perceives his/her body (actual body image) and how he/she wants it to be (ideal body image). To circumvent the limitations of self-report measures of body image, measures were developed that allow for a distinction between actual and ideal body image at the implicit level. The first goal of the present study was to investigate whether self-reported body dissatisfaction is related to implicit measures of actual and ideal body image as captured by the Relational Responding Task (RRT). Secondly, we examined whether these RRT measures were related to several indices of dieting behavior. Women high in body dissatisfaction (n?=?30) were characterized by relatively strong implicit I-am-fat beliefs, whereas their implicit I-want-to-be-thinner beliefs were similar to individuals low in body dissatisfaction (n?=?37). Implicit body image beliefs showed no added value over explicit body image beliefs in predicting body dissatisfaction and dieting behavior. These findings support the idea that the interplay between ideal and actual body image drives (self-reported) body dissatisfaction. However, strong support for the view that it would be critical to differentiate between explicit and implicit body image beliefs is missing.     

Unrecognised myocardial infarction and its relationship to outcome in critically ill patients with cardiovascular disease

Purpose

To establish the incidence of myocardial infarction (MI) in ICU patients with co-existing cardiovascular disease (CVD), and explore its association with long-term survival.

Methods

In a multi-centre prospective cohort study in 11 UK ICUs, we enrolled 273 critically ill patients with co-existing CVD. We measured troponin I (cTnI) with a high sensitivity assay for 10 days; ECGs were carried out daily for 5 days and analysed by blinded cardiologists for dynamic changes. Data were combined to diagnose myocardial ‘infarction’, ‘injury’ or ‘no injury’ according to the third universal definition of MI. Patients were followed-up for 6 months. Regression and mediation analyses were used to explore relationships between acute physiological derangements, MI, and mortality.

Results

cTnI was detected in all patients, with a rise/fall pattern consistent with an acute hit. In 73% of patients, this peaked on days 1–3 [median 114 ng/l (first, third quartiles: 27, 393)]. Serial ECGs indicated 24.2% (n?=?66) of patients experienced MI, but?>?95% were unrecognized by clinical teams. Type 2 MI was the most likely aetiology in all cases. A further 46.1% (n?=?126) experienced injury (no ECG changes). Injury and MI were both associated with 6-month mortality (reference: no injury): OR injury 2.28 (95% CI 1.06–4.92, p?=?0.035), OR MI 2.70 (95% CI 1.11–6.55, p?=?0.028). Mediation analysis suggested MI partially mediated the relationship between acute physiological derangement and 6-month mortality (p?=?0.002), suggesting a possible causal association.

Conclusions

Undiagnosed MI occurs in around a quarter of critically ill patients with co-existing CVD and is associated with lower long-term survival.

     

Selecting Tumor-Specific Molecular Targets in Pancreatic Adenocarcinoma: Paving the Way for Image-Guided Pancreatic Surgery

Purpose

The purpose of this study was to identify suitable molecular targets for tumor-specific imaging of pancreatic adenocarcinoma.

Procedures

The expression of eight potential imaging targets was assessed by the target selection criteria (TASC)—score and immunohistochemical analysis in normal pancreatic tissue (n?=?9), pancreatic (n?=?137), and periampullary (n?=?28) adenocarcinoma.

Results

Integrin α_vβ₆, carcinoembryonic antigen (CEA), epithelial growth factor receptor (EGFR), and urokinase plasminogen activator receptor (uPAR) showed a significantly higher (all p?<?0.001) expression in pancreatic adenocarcinoma compared to normal pancreatic tissue and were confirmed by the TASC score as promising imaging targets. Furthermore, these biomarkers were expressed in respectively 88 %, 71 %, 69 %, and 67 % of the pancreatic adenocarcinoma patients.

Conclusions

The results of this study show that integrin α_vβ₆, CEA, EGFR, and uPAR are suitable targets for tumor-specific imaging of pancreatic adenocarcinoma.

     

On the use of approximate entropy and sample entropy with centre of pressure time-series

Background

Approximate entropy (ApEn) and sample entropy (SampEn) have been previously used to quantify the regularity in centre of pressure (COP) time-series in different experimental groups and/or conditions. ApEn and SampEn are very sensitive to their input parameters: m (subseries length), r (tolerance) and N (data length). Yet, the effects of changing those parameters have been scarcely investigated in the analysis of COP time-series. This study aimed to investigate the effects of changing parameters m, r and N on ApEn and SampEn values in COP time-series, as well as the ability of these entropy measures to discriminate between groups.

Methods

A public dataset of COP time-series was used. ApEn and SampEn were calculated for m?=?{2, 3, 4, 5}, r?=?{0.1, 0.15, 0.2, 0.25, 0.3, 0.35, 0.4, 0.45, 0.5} and N?=?{600, 1200} (30 and 60?s, respectively). Subjects were stratified in young adults (age?<?60, n?=?85), and older adults (age?≥?60) with (n?=?18) and without (n?=?56) falls in the last year. The effects of changing parameters m, r and N on ApEn and SampEn were investigated with a three-way ANOVA. The ability of ApEn and SampEn to discriminate between groups was investigated with a mixed ANOVA (within-subject factors: m, r and N; between-subject factor: group). Specific combinations of m, r and N producing significant differences between groups were identified using the Tukey’s honest significant difference procedure.

Results

A significant three-way interaction between m, r and N confirmed the sensitivity of ApEn and SampEn to the input parameters. SampEn showed a higher consistency and ability to discriminate between groups than ApEn. Significant differences between groups were mostly observed in longer (N?=?1200) COP time-series in the anterior-posterior direction. Those differences were observed for specific combinations of m and r, highlighting the importance of an adequate selection of input parameters.

Conclusions

Future studies should favour SampEn over ApEn and longer time-series (≥ 60?s) over shorter ones (e.g. 30?s). The use of parameter combinations such as SampEn (m?=?{4, 5}, r?=?{0.25, 0.3, 0.35}) is recommended.

     

The Hopelessness Theory of Depression: Clinical Utility and Generalizability

To date, “basic” research has dominated the empirical literature on hopelessness theory. The next logical step in this area of research is to determine if the theory can be used to help people. We conducted three studies to determine if the cognitive vulnerability factor featured in hopelessness theory could be reliably measured in diverse samples in a treatment context and if it could predict depressive therapeutic outcomes. Study 1 used a sample of male juvenile detainees (n?=?296; 70% from underrepresented groups) and found that cognitive vulnerability moderated the effectiveness of a social problem solving training intervention. Study 2 used a clinical sample of U.S. Veterans (n?=?16; 56% from underrepresented groups) enrolled in a cognitive behavioral therapy group for depression and found that cognitive vulnerability predicted post-therapy depressive outcomes. In both Study 1 and Study 2, higher levels of cognitive vulnerability resulted in poorer treatment outcomes (i.e., greater post-treatment levels of depressive symptoms). Study 3 used a clinical sample of U.S. Veterans (n?=?76; 67% from underrepresented groups) enrolled in a behavior activation group and found no effect of cognitive vulnerability on post-therapy depressive outcomes. The results of the three studies indicate that hopelessness theory’s cognitive vulnerability construct can be reliably measured in diverse samples in real world clinical contexts and that it has the potential to be a useful predictor of clinical outcomes in the context of cognitively focused treatments.     

Quantitative Analysis of [<Superscript>18</Superscript>F]FMISO PET for Tumor Hypoxia: Correlation of Modeling Results with Immunohistochemistry

Purpose

Quantitative evaluation of tumor hypoxia based on H-1-(3-[¹⁸F]fluoro-2-hydroxypropyl)-2-nitroimidazole ([¹⁸F]FMISO) positron emission tomography (PET) can deliver important information for treatment planning in radiotherapy. However, the merits and limitations of different analysis methods in revealing the underlying physiological feature are not clear. This study aimed to assess these quantitative analysis methods with the support of immunohistological data.

Procedures

Sixteen nude mice bearing xenografted human squamous cell carcinomas (FaDu or CAL-33) were scanned using 2-h dynamic [¹⁸F]FMISO PET. Tumors were resected and sliced, and the hypoxia marker pimonidazole was immunostained followed by H&E staining. The pimonidazole signal was segmented using a k-means clustering algorithm, and the hypoxic fraction (HF) was calculated as the hypoxic area/viable tumor-tissue-area ratio pooled over three tissue slices from the apical, center, and basal layers. PET images were analyzed using various methods including static analysis [standard uptake value (SUV), tumor-to-blood ratio (T/B), tumor-to-muscle ratio (T/M)] and kinetic modeling (Casciari αk _A , irreversible and reversible two-tissue compartment k ₃, Thorwarth w _A k ₃, Patlak K _i , Logan V _d , Cho K), and correlated with HF.

Results

No significant correlation was found for static analysis. A significant correlation between k ₃ of the irreversible two-tissue compartment model and HF was observed (r?=?0.61, p?=?0.01). The correlation between HF and αk _A of the Casciari model could be improved through reducing local minima by testing more sets of initial values (r?=?0.59, p?=?0.02) or by reducing the model complexity by fixing three parameters (r?=?0.63, p?=?0.0008).

Conclusions

With support of immunohistochemistry data, this study shows that various analysis methods for [¹⁸F]FMISO PET perform differently for assessment of tumor hypoxia. A better fitting quality does not necessarily mean a higher physiological correlation. Hypoxia PET analysis needs to consider both the mathematical stability and physiological fidelity. Based on the results of this study, preference should be given to the irreversible two-tissue compartment model as well as the Casciari model with reduced parameters.

     

Estimation of weight in adults from height: a novel option for a quick bedside technique

Purpose

In critical care situations, there are often neither the means nor the time to weigh each patient before administering strict weight-based drugs/procedures. A convenient, quick and accurate method is a priority in such circumstances for safety and effectiveness in emergent interventions as none exists in adults while those available are complex and yet to be validated. We aimed to study the correlation and accuracy of a quick bedside method of weight estimation in adults using height.

Method

The technique is estimated body weight—eBW(kg)?=?(N ??1)100, where ‘N’ is the measured height in metres.Adult undergraduates were enrolled 10/09/2015. Their heights and weights were measured while the formula was used to obtain the estimated weight. The SPSS version 21.0, Chicago, IL, USA was utilised for data analysis.

Results

We analysed 122 participants aged 21–38?years with height?=?1.55?m–1.95?m. The actual body weight range?=?48.0?kg–91.0 kg, mean?=?65.3?kg?±?9.7?kg and S.E.?=?2.0 while eBW?=?55 kg–95 kg, mean?=?69.1?kg?±?8.4?kg and S.E.?=?1.5. On BMI classes, a positive predictive value of 94.7% for the ‘normal’ category and 95.5% for ‘overweight’.Correlation coefficient at 99% confidence interval yielded (r)?=?+?1, (P?=?0.000) while the linear regression coefficient (r²)?=?+?1 at 95% confidence interval (P?=?0.000).The strength of agreement/precision was established by the Bland-Altman plot at 95%?±?2?s (P?=?0.000) and kappa statistic with value?=?0. 618.

Conclusion

This unprecedented statistical characterisation of the two weight estimate measures to have a good agreement scientifically proposes the utility of our method with the formula eBW(kg)?=?100(N?1) in critical care and ATLS protocol.

     

Relationships between markers of neurologic and endothelial injury during critical illness and long-term cognitive impairment and disability

Purpose

Neurologic and endothelial injury biomarkers are associated with prolonged delirium during critical illness and may reflect injury pathways that lead to poor long-term outcomes. We hypothesized that blood–brain barrier (BBB), neuronal, and endothelial injury biomarkers measured during critical illness are associated with cognitive impairment and disability after discharge.

Methods

We enrolled adults with respiratory failure and/or shock and measured plasma concentrations of BBB (S100B), neuronal (UCHL1, BDNF), and endothelial (E-selectin, PAI-1) injury markers within 72 h of ICU admission. At 3 and 12 months post-discharge, we assessed participants’ global cognition, executive function, and activities of daily living (ADL). We used multivariable regression to determine whether biomarkers were associated with outcomes after adjusting for relevant demographic and acute illness covariates.

Results

Our study included 419 survivors of critical illness with median age 59 years and APACHE II score 25. Higher S100B was associated with worse global cognition at 3 and 12 months (P?=?0.008; P?=?0.01). UCHL1 was nonlinearly associated with global cognition at 3 months (P?=?0.02). Higher E-selectin was associated with worse global cognition (P?=?0.006 at 3 months; P?=?0.06 at 12 months). BDNF and PAI-1 were not associated with global cognition. No biomarkers were associated with executive function. Higher S100B (P?=?0.05) and E-selectin (P?=?0.02) were associated with increased disability in ADLs at 3 months.

Conclusions

S100B, a marker of BBB and/or astrocyte injury, and E-selectin, an adhesion molecule and marker of endothelial injury, are associated with long-term cognitive impairment after critical illness, findings that may reflect mechanisms of critical illness brain injury.

     

Monocausal Attributions Along Cross-Sections of Psychosis Development and Links with Psychopathology and Data Gathering Style

Several attributional biases have been discussed as putative causal factors in psychosis formation and maintenance. The monocausality bias in particular describes the excessive tendency to disregard multifactorial explanations and to instead attribute events to a single cause. To elucidate the role of monocausality in psychosis development, this study compared patients with an at-risk mental state of psychosis (ARMS, n?=?49), first-episode patients (FEP, n?=?35), chronic schizophrenia patients (SZ, n?=?32) and healthy controls (HC, n?=?39) on the Internal Personal and Situational Attributions Questionnaire—Revised. FEP patients made significantly more monocausal attributions than HC to the external-personal locus for positive events. Moreover, monocausality was linked with psychotic as well as depressive symptoms and tentatively also with a hasty data gathering style. Future studies should explore associations with other metacognitive deficits and the potential to prevent or correct the monocausality bias through psychological interventions.     

Effects of Tiotropium Combined with Theophylline on Stable COPD Patients of Group B,D and its Impact on Small Airway Function: A Randomized Controlled Trial

Introduction

Tiotropium bromide has been widely used in clinical practice, while theophylline is another treatment option for chronic obstructive pulmonary disease (COPD). However, only a few relevant studies have investigated the long-term outcomes and efficacy of both in patients with COPD. We evaluated the effects of tiotropium and low-dose theophylline on stable COPD patients of groups B and D.

Methods

Eligible participants (n?=?170) were randomized and received either tiotropium 18 µg once daily with theophylline 100 mg twice daily (Group I) or tiotropium 18 µg once daily (Group II) for 6 months. COPD assessment test (CAT), modified Medical Research Council (mMRC) dyspnea scores and pulmonary function tests were measured before randomization and during the treatment.

Results

After 6 months of treatment, the CAT scores in both groups decreased significantly (11.41?±?3.56 and 11.08?±?3.05, p?<?0.0001). The changes of CAT (p?=?0.028) and mMRC scores (p?=?0.049) between the two groups differed after 1 month of treatment. In Group I, forced expiratory flow after 25% of the FVC% predicted (MEF₂₅% pred) was significantly improved after 3 months (4.84?±?8.73%, p?<?0.0001) and 6 months (6.21?±?8.65%, p?<?0.0001). There was a significant difference in small airway function tests (MEF₅₀% pred, MEF₂₅% pred, and MMEF% pred) between the two groups after 6 month of treatment (p?=?0.003, p?<?0.0001, and p?=?0.021, respectively).

Conclusions

Tiotropium combined with low-dose theophylline significantly improved the symptoms and general health of patients with stable COPD of groups B and D after 6 months of follow-up. Additionally, this therapy also improved the indicators of small airway function.

Trial Registration

Chinese Clinical Trial Registry (Registry ID: ChiCTR1800019027).

     

Measuring cognitive complaints in breast cancer survivors: psychometric properties of the patient’s assessment of own functioning inventory

Purpose

Cognitive complaints are a concern for breast cancer survivors. Among various published measures for cognitive complaints, the Patient’s Assessment of Own Functioning Inventory (PAOFI) is one of the few assessing a spectrum of cognitive abilities, including those most commonly reported by breast cancer survivors. This study aimed to examine the psychometric properties of the PAOFI in breast cancer survivors.

Methods

An exploratory factor analysis was conducted with a sample of breast cancer survivors (n?=?189) who had completed all primary cancer treatments. Construct validity was examined by correlating factor scores with valid measures of cognitive complaints, fatigue, and quality of life. Reliability was measured by internal consistency of the items in each factor within this sample, a separate sample of breast cancer survivors with high persistent cognitive complaints (n?=?72), and healthy controls (n?=?63). Factor scores were compared across the three samples.

Results

A five-factor structure similar to the PAOFI standardization study was found, with factors related to executive functioning (accounting for most of the variance), two aspects of memory functioning, language, and motor/sensory-perceptual abilities. Factor scores highly correlated with measures of cognitive complaints, fatigue, and quality of life. Executive functioning and memory-related factors achieved adequate reliability across samples. Scores were significantly different across the three samples as expected.

Conclusions

The PAOFI is a reliable and valid tool for measuring cognitive complaints in breast cancer survivors.

     

The Processes of Cognitive Behavioral Therapy: A Review of Meta-Analyses

Cognitive Behavioral Therapy (CBT) refers to a treatment approach with strong empirical support for its efficacy for various disorders and populations. The goal of the present review was to provide a comprehensive survey of meta-analyses examining the processes of CBT, namely: treatment processes (cognitive reappraisal, behavioral strategies, emotional regulation, motivation strategies, and psychoeducation) and in-session processes (alliance, goal consensus and collaboration, feedback, group cohesion, and homework). We identified 558 meta-analyses of CBT, and 30 meta-analyses met our inclusion criteria as reviews of process-outcome relations. For treatment processes, the strongest support currently exists for cognitive (n?=?8 meta-analyses) and behavioral strategies (n?=?3 meta-analyses) as change processes in CBT for anxiety disorders and depression. For in-session processes, the strongest support currently exists for the role of the alliance (n?=?8 meta-analyses) and homework assignments (n?=?6 meta-analyses) as predictors of outcome. Overall, the evidence base for process-outcome relations in CBT is just emerging. Additional research is needed to examine the range of treatment processes in various clinical contexts. Moreover, except for a meta-analysis on collaboration, no meta-analytic studies have been reported on CBT-specific elements of the therapeutic relationship, such as collaborative empiricism and Socratic dialogue.     

Cannabinoide in der palliativen Versorgung

Background

Cannabinoids have multiple medical indications in palliative care, such as relief of pain or nausea or increase of appetite and weight stabilisation. The value of cannabinoids for these indications is not resolved sufficiently for palliative patients. A systematic review with meta-analysis of the efficacy, tolerability and safety on the basis of randomised controlled studies (RCT) or randomised open label or crossover studies has not yet been conducted.

Materials and methods

An extensive search for RCTs, randomised open label or crossover studies dealing with the underlying question was performed in the databases of Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, PsycINFO, PubMed, Scopus and Clinicaltrials.gov up to April 2015. Studies with a duration of ≥?2 weeks and ≥?10 participants per treatment group were included into analysis. Using a random effects model, pooled estimates of event rates for categorical data and standardized mean differences (SMD) for continuous variables and risk differences (RD) for dichotomous variables were calculated.

Results

Out of initially 108 studies 9, with a total of 1561 participants suffering from advanced or end stage diseases, were included. The median study duration of the cancer research was 8 weeks (16 days–11 weeks), of the HIV research 6 weeks (3–12 weeks) and of the study concentrating on Alzheimer?s 2?×?6 weeks. The outcome results for cannabis/cannabinoids vs. placebo in patients with cancer were not significant for the 30?% decrease in pain (RD: 0.07; 95?% confidence interval (CI): ??0.01 to 0.16; p?=?0.07), caloric intake (SMD: 0.2; 95?% CI: ??0.66 to 1.06; p?=?0.65) or sleep problems (SMD: ??0.09; 95?% CI: ??0.62 to 0.43; p?=?0.72). In the treatment of HIV cannabinoids were superior to placebo for the outcome of weight change (SMD: 0.57; 95?% CI: 0.22–0.92; p?=?0.001). Change in appetite was significant for the treatment of HIV (SMD: 0.57; 95?% CI: 0.11–1.03; p?=?0.02), but not for treatment of cancer (SMD: 0.81; 95?% CI: ??1.14 to 2.75; p?=?0.42). Nausea/vomiting (SMD: 0.20; 95?% CI: ??0.03 to 0.44; p?=?0.09) and health-related quality of life (HRQoL; SMD: 0.00; 95?% CI: ??0.19 to 0.18; p?=?0.98) did not show significant differences in the therapy of the two diseases. For the outcomes of tolerability the results were not significant for occurrence of dizziness (RD: 0.03; 95?% CI: ??0.02 to 0.08; p?=?0.23) or psychiatric diseases, such as hallucinations or psychosis (RD: ??0.01; 95?% CI: ??0.04 to 0.03; p?=?0.69) in the therapy of cancer. The outcome of psychiatric diseases in the treatment of HIV was significant (RD: 0.05; 95?% CI: 0.00–0.11; p?=?0.05). The number of withdrawals due to adverse events, as a marker for tolerability, and the reports of serious adverse events as a measure of safety was not significantly different (RD: 1.20; 95?% CI: 0.85–1.71; p?=?0.30 and RD: 1.15; 95?% CI: 0.88–1.49; p?=?0.30, respectively). Dronabinol vs. megestrol acetate showed a superiority of megestrol in the therapy of cancer-associated anorexia for the endpoints change of appetite (49 vs. 75?%; p?=?0.0001), weight gain (3 vs. 11?%; p?=?0.02), HRQoL (p?=?0.003) and tolerability (p?=?0.03). There was no difference in the safety of the therapies (p?=?0.12). In the treatment of HIV-associated wasting syndrome megestrol acetate was better than dronabinol for the endpoint of weight gain (p?=?0.0001), whereas tolerability and safety did not differ. In the therapy of Alzheimer’s dronabinol was better than placebo in the endpoint of weight gain according to one study (n?=?15). A difference between herbal cannabis and synthetic cannabinoids, analysed by one study (n?=?62) could not be found.

Conclusion

Cannabinoids can lead to an increase in appetite in patients with HIV wasting syndrome but the therapy with megestrol acetate is superior to treatment with cannabinoids. The included studies were not of sufficient duration to answer questions concerning the long-term efficacy, tolerability and safety of therapy with cannabis or cannabinoids. Due to the sparse amount of data it is not possible to recommend a favoured use of cannabis or cannabinoids at this point.

     

Clinical Efficacy and Safety of Current Interventions for Choroidal Neovascularization Associated with Rare Diseases: A Systematic Literature Review

Introduction

The aim of this systematic literature review was to evaluate the efficacy and safety of interventions for the treatment of choroidal neovascularization (CNV) secondary to etiologies other than age-related macular degeneration and pathologic myopia.

Methods

Relevant randomized controlled trials (RCTs) and prospective observational studies were identified by searching MEDLINE, MEDLINE In-Process, EMBASE, and CENTRAL.

Results

The search identified 5 RCTs; no relevant observational studies were identified. The studies differed in terms of underlying cause of CNV, patient numbers (n?=?9–178), follow-up time (2–36 months) and quality assessment. In the largest RCT (n?=?178 across a range of rare CNV etiologies), intravitreal ranibizumab showed superior efficacy versus sham from baseline to month 2 [mean best-corrected visual acuity (BCVA): +?9.5 vs. ??0.4 letters; p?<?0.001]; the gain was maintained up to month 12. In the treatment of CNV secondary to presumed ocular histoplasmosis syndrome (POHS), both intravitreal ranibizumab and photodynamic therapy (PDT) showed significant improvement from baseline BCVA over the 12-month period (n?=?9); however, all patients in the PDT group required rescue ranibizumab therapy. Unlicensed intravitreal bevacizumab was associated with a statistically significant improvement in BCVA compared to PDT at 12 months (p?<?0.001) in patients with CNV secondary to multifocal choroiditis (n?=?27). The use of steroids before PDT showed better BCVA outcomes than PDT alone (p?<?0.05) in patients with idiopathic CNV (n?=?20). Argon green laser therapy showed limited efficacy in patients with CNV secondary to OHS (n?=?134).

Conclusion

There is evidence from a relatively large, good-quality study to support the use of intravitreal ranibizumab for the treatment of CNV secondary to rare diseases. However, the limited number of RCTs for this indication and differences in study characteristics between RCTs mean that there is uncertainty regarding comparative clinical effectiveness of interventions. RCTs with an active comparator are required to fully establish the comparative effectiveness of treatments for CNV secondary to rare diseases.

Funding

Novartis Pharmaceuticals UK Ltd, Surrey, UK.

     

Cerebrolysin for the Treatment of Aneurysmal Subarachnoid Hemorrhage in Adults: A Retrospective Chart Review

Introduction

Cerebrolysin is a neuroprotective drug used in the treatment of acute ischemic stroke. To our knowledge, this drug has never been evaluated in patients with aneurysmal subarachnoid hemorrhage (SAH). The aim of this study was to evaluate the effect of Cerebrolysin in patients with aneurysmal SAH.

Methods

Aneurysmal SAH patients who had their aneurysm obliterated at our institution from 2007 to 2016 were retrospectively studied. Patients received Cerebrolysin treatment or standard care only (control group). Subgroup analyses were performed according to Hunt and Hess grade (good grade?≤?2, N?=?216; poor grade?≥?3, N?=?246) and treatment procedure (clip or coil).

Results

In good-grade patients (N?=?216), clinical outcomes and mortality did not differ significantly between the control and Cerebrolysin groups. In poor-grade patients (N?=?246), the mortality rate was significantly lower in the Cerebrolysin group (8.7%) than in the control group (25.4%, p?=?0.006). In patients who received microsurgical clipping (N?=?328), the mortality rate was significantly lower in the Cerebrolysin group (7.3%) than in the control group (18.5%, p?=?0.016).

Conclusion

Cerebrolysin injection during the acute period of SAH appeared to reduce the mortality rate, especially in poor-grade patients. This study suggests the potential of Cerebrolysin for treating aneurysmal SAH. Further studies are needed to confirm our results.

     

Positive and Negative Affective Forecasting in Remitted Individuals with Bipolar I Disorder,and Major Depressive Disorder,and Healthy Controls

Although emotional disturbances characterize mood disorders, little is known about the affective forecasts of these individuals. We examined forecasted intensity and accuracy for negative affect (NA) and positive affect (PA) among two remitted clinical groups: individuals with Bipolar I (BD; n?=?31) and Major Depressive Disorder (MDD; n?=?21), and healthy controls (CTL; n?=?32). We also examined whether each group’s forecasting accuracy varied by valence. At the lab, participants forecasted their short-term (next day) and long-term (next week) NA and PA; then they completed a week of experience sampling. The MDD group forecasted lower PA and higher NA than the CTL group; the BD group’s forecasts varied across time frames. There were no group differences in forecasting accuracies. Regarding within group forecasting accuracy, the CTL group was more accurate in PA than NA; the BD group was similarly accurate across valence, and the MDD group’s accuracy varied based on the time frame.     

Mothers’ Scaffolding Techniques Used During Play in Toddlers with Autism Spectrum Disorder

Play allows toddlers to appropriately engage with others, and an important facilitator of play is scaffolding. Researchers demonstrate that parents of toddlers with typical development scaffold their play beginning at 12 months. However, this pattern is unknown in parents of toddlers with autism spectrum disorder (ASD). This study (n?=?3; M _age?=?26.5 months) examined mothers’ scaffolding techniques used during a social-communication intervention for toddlers with ASD while also assessing the toddlers’ play. Mothers’ scaffolding techniques (comments, requests, prompts) were explored during mother-toddler play samples. Results showed that mothers’ scaffolding techniques increased, and all toddlers exhibited pretend play by the end of intervention. Thus, scaffolding during play is an important contribution in spurring toddlers with ASD to reach their potential.