Determining an optimal dose of linaclotide for use in Japanese patients with irritable bowel syndrome with constipation: A phase II randomized,double‐blind,placebo‐controlled study

Background

Clinical testing to determine a suitable dose of linaclotide for Japanese patients with irritable bowel syndrome with constipation (IBS‐C) was needed.

Methods

This was a randomized, double‐blind, placebo‐controlled, dose‐finding trial. Japanese patients with IBS‐C diagnosed using Rome III criteria (n = 559, men/women: 49/510) were randomly assigned to 1 of 4 linaclotide doses (0.0625, 0.125, 0.25, or 0.5 mg) or placebo for the 12‐week treatment period. The primary endpoint was responder rate of global assessment of relief of IBS symptoms during 12 weeks. The secondary endpoints included responder rates of complete spontaneous bowel movement (CSBM), SBM and abdominal pain/discomfort relief and others.

Key Results

The primary endpoint was 23.2%, 36.2%, 38.7%, 34.8%, and 38.3% in placebo (n = 112), 0.0625 (n = 116), 0.125 (n = 111), 0.25 (n = 112), and 0.5 (n = 107) mg of linaclotide groups with the difference from the placebo group in each linaclotide group (13.0%, 15.5%, 11.6%, 15.1%, P > .05). Monthly responder rate of global assessment of relief of IBS symptoms at month 3 (48.6%), responder rate of CSBM during 12 weeks (45.8%), and responder rate of abdominal pain/discomfort relief during 12 weeks (32.7%) in the 0.5 mg were significantly higher than those in placebo group (29.5%, P < .01; 25.9%, P < .01; and 18.8%, P < .05 respectively). The most frequent adverse event in the linaclotide groups was diarrhea.

Conclusions & Inferences

This study suggests that a linaclotide dose of 0.5 mg may be appropriate in Japanese patients with IBS‐C.     

Clozapine as a first‐ or second‐line treatment in schizophrenia: a systematic review and meta‐analysis

Objective

No consensus exists on whether clozapine should be prescribed in early stages of psychosis. This systematic review and meta‐analysis therefore focus on the use of clozapine as first‐line or second‐line treatment in non‐treatment‐resistant patients.

Methods

Articles were eligible if they investigated clozapine compared to another antipsychotic as a first‐ or second‐line treatment in non‐treatment‐resistant schizophrenia spectrum disorders (SCZ) patients and provided data on treatment response. We performed random‐effects meta‐analyses.

Results

Fifteen articles were eligible for the systematic review (N = 314 subjects on clozapine and N = 800 on other antipsychotics). Our meta‐analysis comparing clozapine to a miscellaneous group of antipsychotics revealed a significant benefit of clozapine (Hedges’ g = 0.220, P = 0.026, 95% CI = 0.026–0.414), with no evidence of heterogeneity. In addition, a sensitivity analysis revealed a significant benefit of clozapine over risperidone (Hedges’ g = 0.274, P = 0.030, 95% CI = 0.027–0.521).

Conclusion

The few eligible trials on this topic suggest that clozapine may be more effective than other antipsychotics when used as first‐ or second‐line treatment. Only large clinical trials may comprehensively probe disease stage‐dependent superiority of clozapine and investigate overall tolerability.     

Abnormal small bowel motility in patients with hereditary transthyretin amyloidosis

Background

Gastrointestinal complications are common in hereditary transthyretin amyloid (ATTRm) amyloidosis. The underlying mechanisms have not been fully elucidated, and the patients’ small bowel function remains largely unexplored. The aim of the present study was to compare the small bowel motility in ATTRm amyloidosis patients with that in non‐amyloidosis patient controls.

Methods

ATTRm amyloidosis patients undergoing evaluation for liver transplantation were consecutively investigated with 24‐hour duodenojejunal manometry (n = 19). The somatostatin analogue octreotide was used to induce fasting motility. Patients with age at onset of ≥50 years were defined as late‐onset cases. For each patient, three age‐ and sex‐matched patient controls (n = 57) were selected from the total pool of investigated patients.

Key Results

Manometry was judged as abnormal in 58% of the patients and in 26% of the patient controls (P = .01). Patients displayed significantly more daytime phase III migrating motor complexes than patient controls (median 4 vs 2, P < .01), and had a higher frequency of low‐amplitude complexes (16% vs 4%; however, this difference did not reach statistical significance, P = .10). Furthermore, late‐onset patients showed a delay in octreotide response (5.4 vs 3.8 minutes, P < .01), but this was not observed for early‐onset patients or within the control group.

Conclusions and Inferences

Patients with ATTRm amyloidosis displayed abnormalities in their small bowel motility more frequently than non‐amyloidosis patient controls, and the manometric pattern was probably best consistent with a combined neuromyopathic disorder. The delayed octreotide response in late‐onset patients warrants further investigation.     

Statins and cognition in late‐life bipolar disorder

Objectives

Recent data suggests that statins have positive effects on cognition in older adults. Studies in patients with mood disorders have found contradicting positive and negative effects of statins on mood and cognition, with limited data in bipolar disorder (BD). The objective of this study was to assess the association between statin use and cognition in older adults with BD.

Methods

In a cross‐sectional sample of 143 euthymic older adults with BD (age ≥ 50), statin users (n = 48) and nonusers (n = 95) were compared for cognitive outcomes: Global and cognitive domain z‐scores were calculated from detailed neuropsychological batteries using normative data from healthy comparators (n = 87).

Results

The sample had a mean age of 64.3 (±8.9) years, 65.0% were female, with an average of 15.1 (±2.79) years of education. Statin users did not differ from nonusers on global (?0.60 [±0.69] vs ?0.49 [±0.68], t[127] = 0.80, P = .42) or individual cognitive domains z‐score.

Conclusions

In older patients with BD, statin use is not independently associated with cognitive impairment. This suggests that in older BD patients, the cognitive dysfunction associated with BD trumps the potential cognitive benefit that is associated with statins in older adults without a psychiatric disorder. Further, statins do not seem to exacerbate this cognitive dysfunction. Future longitudinal studies are needed to confirm these findings.     

Prevalence,correlates and impact of pain and cramps in anti‐MAG neuropathy: a multicentre European study

Background and purpose

The frequency of pain and cramps is uncertain in anti‐myelin associated glycoprotein antibody (anti‐MAG) neuropathy. Whether these symptoms may affect function/quality of life is unknown.

Methods

A cross‐sectional study of the prevalence, correlates and impact of pain, pain subtypes and cramps, their severity, frequency and anatomical distribution was performed for 55 clinically stable patients with anti‐MAG neuropathy.

Results

Pain of any type was reported by 80% of subjects. The most common subtype was paraesthesiae and dysaesthesiae (70%). Cramps were reported by >60% of patients, with lower limb cramps in all and upper limb cramps in about 20%. Cramps affected daily activities in >30% of these subjects, sleep in 60%, ability to exercise in >30%. Total pain score correlated with several Short Form 36 health‐related quality of life (SF‐36 HR‐QoL) measures (P < 0.05), with Inflammatory Rasch‐built Overall Disability Scale (I‐RODS) (P = 0.006) and 10‐m timed walk (P = 0.019). An independent association was ascertained with I‐RODS (P = 0.002). Different pain subtypes showed multiple associations with SF‐36 HR‐QoL measures and/or functional scales. Upper limb cramps had multiple SF‐36 HR‐QoL functional correlates, with an independent association with the Overall Neuropathy Limitation Score (ONLS) (P = 0.004). Cramp severity correlated with ONLS (P = 0.04) and I‐RODS (P = 0.028) and inversely with level of physiotherapy input (P = 0.009). Cramp frequency was associated with tremor score (P = 0.004) and multiple SF‐36 HR‐QoL subsections.

Conclusions

Neuropathic pain and cramps may affect function and quality of life in anti‐MAG neuropathy. Optimizing treatments of these symptoms, including by adequate levels of physiotherapy, may be beneficial in affected patients and requires further research.     

4D-CT angiography differentiating arteriovenous fistula subtypes

Objective and methods

In the diagnostic work-up of patients suspected of a dural arteriovenous fistula (dAVF), imaging has a key role in order to diagnose the dAVF, assess its bleeding risk and choose optimal treatment strategy. Digital subtraction angiography (DSA) is the gold standard for the most detailed image of a dAVF. Nowadays four-dimensional CT angiography (4D-CTA) could possibly be an additional first-line tool in the work-up of a patient suspected of a dAVF. We describe three cases clinically suspected of a dAVF which had a diagnostic work-up with 4D-CTA as well as DSA. We evaluated the angioarchitecture of the dAVF both on 4D-CTA and DSA, with emphasis on the patterns of venous drainage as this is important in assessing the bleeding risk of a dAVF.

Results and conclusion

4D-CTA identified the dAVF, revealed its angioarchitecture and correctly differentiated different patterns of venous drainage (Borden type I, II and III) as confirmed on DSA. Although DSA has the advantage of higher spatial and temporal resolution, 4D-CTA seems to be a new useful non-invasive tool in the diagnostic work-up of a patient suspected of a dAVF.     

Mitochondrial DNA m.13514G>A heteroplasmy is associated with depressive symptoms in the elderly

Objectives

Mitochondrial DNA (mtDNA) heteroplasmy is a mixture of normal and mutated mtDNA molecules in a cell. High levels of heteroplasmy at several mtDNA sites in complex I lead to inherited neurological neurologic diseases and brain magnetic resonance imaging (MRI) abnormalities. Here, we test the hypothesis that mtDNA heteroplasmy at these complex I sites is associated with depressive symptoms in the elderly.

Methods

We examined platelet mtDNA heteroplasmy for associations with depressive symptoms among 137 participants over age 70 from the community‐based Health, Aging and Body Composition Study. Depressive symptoms were assessed using the 10‐point version of the Center for Epidemiologic Studies Depression Scale (CES‐D 10). Complete mtDNA sequencing was performed and heteroplasmy derived for 5 mtDNA sites associated with neurologic mitochondrial diseases and tested for associations with depressive symptoms.

Results

Of 5 candidate complex I mtDNA mutations examined for effects on depressive symptoms, increased heteroplasmy at m.13514A>G, ND5, was significantly associated with higher CES‐D score (P = .01). A statistically significant interaction between m.13514A > G heteroplasmy and sex was detected (P = .04); in sex‐stratified analyses, the impact of m.13514A>G heteroplasmy was stronger in male (P = .003) than in female (P = .98) participants. Men in highest tertile of mtDNA heteroplasmy exhibited significantly higher (P = .0001) mean ± SE CES‐D 10 scores, 5.37 ± 0.58, when compared with those in the middle, 2.13 ± 0.52, and lowest tertiles, 2.47 ± 0.58. No associations between the 4 other candidate sites and depressive symptoms were observed.

Conclusions

Increased mtDNA heteroplasmy at m.13514A>G is associated with depressive symptoms in older men. Heteroplasmy may represent a novel biological risk factor for depression.     

Brivaracetam as add‐on treatment in focal epilepsy: A real‐world time‐based analysis

The study assessed the clinical response to add‐on brivaracetam (BRV) in real‐world practice by means of time‐to‐baseline seizure count methodology. Patients with focal epilepsy who were prescribed add‐on BRV were identified. Primary endpoint was the time‐to‐baseline seizure count defined as the number of days until each patient experienced the number of focal seizures that occurred in the 90 days before BRV initiation. Subgroup analysis was performed according to levetiracetam (LEV) status (naive vs prior use). Three‐hundred eighty‐seven patients were included. The overall median time‐to‐baseline seizure count was 150 (95% confidence interval [CI] = 130‐175) days. The median time‐to‐baseline seizure count was 198 (lower limit of 95% CI = 168) days for LEV‐naive patients, 126 (95% CI = 105‐150) days for patients with prior LEV use and withdrawal due to insufficient efficacy, and 170 (95% CI = 128‐291) days for patients who discontinued LEV due to adverse events (P = .002). The number of prior antiseizure medications (adjusted hazard ratio [_adjHR] = 1.07, 95% CI = 1.02‐1.13, P = .009) and baseline monthly seizure frequency (_adjHR = 1.004, 95% CI = 1.001‐1.008, P = .028) were independently associated with the primary endpoint. Add‐on BRV improved seizure control in LEV‐naive and LEV‐prior patients. The time‐to‐baseline seizure count represents an informative endpoint alongside traditional study outcomes and designs.     

Orthostatic hypotension in patients with late‐life depression: Prevalence and validation of a new screening tool

Objectives

The objective of this study was to assess the prevalence of orthostatic hypotension (OH) in a sample of late life depression (LLD) patients and to determine the validity of a standardized questionnaire, the Orthostatic Hypotension Questionnaire (OHQ). Secondarily, we wished to assess variables associated with OH.

Methods

We conducted a cross‐sectional study on 82 consecutive geriatric outpatients presenting with LLD. OH was defined as a fall in systolic blood pressure of greater than 20 mm Hg and/or 10 mm Hg on diastolic blood pressure on an orthostatic stress test from sitting to standing. Logistic regressions were used to identify factors associated with OH.

Results

The prevalence of OH as measured on the orthostatic stress test and on the OHQ was 28% and 57%, respectively. The sensitivity, specificity, accuracy, positive predictive value, and negative predictive value of the OHQ were 69.6% (95% CI 47%‐87%), 47.5% (95%CI 34%‐61%), 0.54 (95% CI: 0.43‐0.64), 34% (95%CI 21%‐49%), and 80% (95%CI 63%‐92%), respectively. Females were more likely to have OH (OR: 3.96, 95%CI 1.06‐14.89, P = .041), and those married or in a common‐law relationship were less likely to have OH (OR: 0.25, 95% CI 0.08‐0.72, P = .011).

Conclusions

OH is common in patients with LLD conferring them a risk of gait instability and falls. Females had a higher risk of having OH while participants who were married or in a common‐law relationship were less likely to have OH. Although the OHQ is a quick to administer paper‐based screening test, it did not show adequate diagnostic accuracy in patients with LLD seen in a routine psychiatry clinic.     

Stress and coping mechanisms among adolescents living in orphanages: An experience from Klang Valley,Malaysia

Introduction

Health issues often differ from one population to another. Assessing different aspects of the health condition is a vital step toward developing and designing appropriate prevention and treatment programs to reduce health problems in any group or population. This study aimed to assess both the prevalence of stress and the coping mechanisms as well as identify the predictors of stress levels among adolescents in Malaysian orphanages.

Methods

Overall, 307 male and female adolescents (aged 13‐18 y old) living in 9 private orphanages located in Klang Valley, Malaysia, participated in this cross‐sectional study. Brief COPE scale and Depression, Anxiety and Stress Scale‐21 were used as the main instruments in the current study.

Results

The results of the current study showed female adolescents and participants with a higher level of education were more likely to experience stress. The results also showed significant differences between boys and girls in using of coping mechanisms in self‐distraction (t = ?2.39, P = .01), substance use (t = 2.12, P = .03), use of emotional support (t = ?2.70, P = .001), humor (t = 2.28, P = .02), and religion (t = ?2.19, P = .02). Denial, venting, religion, humor, planning, and active coping were identified as predictors of stress among participants.

Discussion

The results showed a high prevalence of stress and a negative coping pattern among participants. The finding of the current study also showed the urgency of taking immediate action to reduce stress and improve coping methods among Malaysian institutional adolescents.     

Persistence of depressive symptoms and gait speed recovery in older adults after hip fracture

Objective

Depression after hip fracture in older adults is associated with worse physical performance; however, depressive symptoms are dynamic, fluctuating during the recovery period. The study aim was to determine how the persistence of depressive symptoms over time cumulatively affects the recovery of physical performance.

Methods

Marginal structural models estimated the cumulative effect of persistence of depressive symptoms on gait speed during hip fracture recovery among older adults (n = 284) enrolled in the Baltimore Hip Studies 7th cohort. Depressive symptoms at baseline and at 2‐month and 6‐month postadmission for hip fracture were evaluated by using the Center for Epidemiological Studies Depression Scale, and persistence of symptoms was assessed as a time‐averaged severity lagged to standardized 3 m gait speed at 2, 6, and 12 months.

Results

A 1‐unit increase in time‐averaged Center for Epidemiological Studies Depression score was associated with a mean difference in gait speed of ?0.0076 standard deviations (95% confidence interval [CI]: ?0.0184, 0.0032; P = .166). The association was largest in magnitude from baseline to 6 months: ?0.0144 standard deviations (95% CI: ?0.0303, 0.0015; P = 0.076). Associations for the other time intervals were smaller: ?0.0028 standard deviations (95% CI: ?0.0138, 0.0083; P = .621) at 2 months and ?0.0121 standard deviations (95% CI: ?0.0324, 0.0082; P = .238) at 12 months.

Conclusion

Although not statistically significant, the magnitude of the numerical estimates suggests that expressing more depressive symptoms during the first 6 months after hip fracture has a meaningful impact on functional recovery.     

Effects of pain treatment on sleep in nursing home patients with dementia and depression: A multicenter placebo‐controlled randomized clinical trial

Objective

To investigate the effects of pain treatment on sleep in nursing home (NH) patients with dementia and depression.

Methods

A multicenter, 2‐armed, double‐blinded, placebo‐controlled, randomized clinical trial conducted between August 2014 and September 2016. One hundred six long‐term patients from 47 NHs in Norway with dementia and depression according to the Mini‐Mental State Examination and the Cornell Scale for Depression in Dementia were included. Patients received stepwise pain treatment in which those who did not use analgesics were randomized to receive either paracetamol (3 g/day) or placebo tablets; those who already used pain treatment were allocated to buprenorphine transdermal system (max. 10 μg/h/7 days) or placebo transdermal patches. Sleep was assessed continuously for 14 days by actigraphy, 1 week of baseline measurement, and 1 week of ongoing treatment. The following sleep parameters were evaluated: total sleep time, sleep efficiency (SE), sleep onset latency (SOL), wake after sleep onset, early morning awakening (EMA), and number of wake bouts.

Results

In the intervention group (paracetamol/buprenorphine), SE (70%‐72%), SOL (32‐24 min), and EMA (50‐40 min) improved compared with the control group (SE, 70%‐67%; SOL, 47‐60 min; EMA, 31‐35 min). Treatment effects were significant (P < .01, P < .05, and P < .05, respectively).

Conclusion

Compared with placebo, pain treatment improved sleep as measured with actigraphy. This implies that sleep, pain, and depression in NH patients should be critically evaluated and that pain treatment should be considered to be a potentially beneficial treatment.     

Measuring change in perceived well‐being of family caregivers: validation of the Spanish version of the Perceived Change Index (PCI‐S) in Chilean dementia caregivers

Objective

Few instruments evaluate family caregiver perceptions of challenges caring for persons with dementia and improvement or worsening in these areas. To address this measurement gap, we examine psychometric properties of a Spanish version of the 13‐item Perceived Change Index (PCI‐S), originally validated with English‐speaking caregivers.

Methods

Cross‐sectional study with 94 caregivers of persons with mild to moderate dementia in Chile. Interviews included caregiver demographics, burden, health perception, distress with behaviours, dementia severity, behavioural symptoms and functionality.

Results

Caregiver mean age was 55.9 (SD ± 14.14) years and mean years caregiving was 3 (SD ± 2.60). The scale had strong internal consistency (Cronbach α = 0.94), and inter‐observer consistency (CCI = 0.99; 95% CI = 0.95–0.99). Two factors were identified: Management skills (α = 0.89), and somatic well‐being and affects (α = 0.92), explaining 63% of scale variance. Significant associations supporting convergent validity were observed for PCI‐S and subscales with caregiver burden (p < 0.01), health perceptions (p < 0.01), depressive symptoms (p < 0.01) and distress with behaviours (p < 0.01); and in persons with dementia, functionality (p < 0.05), dementia severity (p < 0.05) and behavioural symptoms (p < 0.01) in expected directions. In logistic regression models, perceived worsening (PCI‐S and subscale scores) was associated with more behavioural symptoms (OR = 1.07; 95% CI = 1.03–1.15) and caregiver burden (OR = 1.48; 95% CI = 1.18–1.86); whereas perceived improvement was associated with higher physical functioning (OR = 0.95; 95% CI = 0.91–0.99) in persons with dementia. PCI‐S scores were not associated with socio‐demographic characteristics reflecting divergent validity.

Conclusions

Spanish version of the 13‐item Perceived Change Index and its two‐factor solution is a valid and reliable measure with clinical utility to detect improvement or worsening in caregivers concerning daily care challenges. Copyright © 2017 John Wiley & Sons, Ltd.     

Complication Burden Index—A tool for comprehensive evaluation of the effect of complications on functional outcome after status epilepticus

Systemic complications are common in status epilepticus. We have no tools to evaluate total burden of complications and its effect on the outcome of status epilepticus. For Complication Burden Index (CBI) a patient is assessed for 13 complication categories: respiratory, cardiovascular, nervous, renal, hepatic, coagulation, gastrointestinal and musculoskeletal systems, electrolyte/acid‐base balance, infection, hypo‐/hyperglycemia, skin/allergic reactions, and mental condition. Maximum CBI is 13. CBI was internally validated in a retrospective cohort of 70 consecutive adult patients with generalized convulsive status epilepticus (GCSE) treated in a tertiary hospital over a period of 2 years. Functional outcome at discharge was defined Poor for Glascow Outcome Scale (GOS) 1‐3 or worse‐than‐baseline condition and Good for GOS >3 or return to baseline condition. Relative risks (RRs) and receiver‐operating characteristic (ROC) ‐curves were calculated to obtain optimal cutoff. Functional outcome was poor in 40% and worse‐than‐baseline in 59%. In‐hospital mortality was 7%. Average CBI was 3.8 (range 0‐10, median 3). Cutoff value predicting poor functional outcome was a CBI >3 (GOS 1‐3 RR 1.84, P = .045, 95% confidence interval [CI 1.01‐3.33; ROC‐AUC [area under the curve] 0.687, P = .008, sensitivity 64%, specificity 61%; worse‐than‐baseline condition RR 1.52, P = .04, 95% CI 1.02‐2.26; ROC‐AUC 0.662, P = .022, sensitivity 56%, specificity 69%). CBI with cutoff >3 and as a continuous variable was associated with GOS1‐3 (P = .046, P = .002) and with worse‐than‐baseline condition (P = .041, P = .004). CBI is a novel tool for comprehensive assessment of status epilepticus complications predicting poor/worse‐than‐baseline functional outcome with cutoff >3.     

Efficacy and safety of perampanel in generalized and focal to bilateral tonic‐clonic seizures: A comparative study of Asian and non‐Asian populations

Perampanel is an approved adjunctive treatment for focal seizures with or without focal to bilateral tonic‐clonic (FBTC) seizures and generalized tonic‐clonic (GTC) seizures. We compared efficacy and safety of perampanel vs placebo in Asian and non‐Asian populations in a post hoc analysis of pooled data from 5 randomized phase 3 studies. Patients (≥12 years old) with focal + FBTC seizures received perampanel 2, 4, 8, or 12 mg or placebo; patients with GTC seizures received perampanel 8 mg or placebo (titration: 4‐6 weeks; maintenance: 13 weeks). Efficacy endpoints included median percentage change in FBTC or GTC seizure frequency per 28 days and 50% responder rate relative to baseline. Median percentage change in FBTC seizure frequency was significantly greater for perampanel 8 and 12 mg than placebo in the Asian population (median difference from placebo: ?30.32%, P = 0.0017; ?30.06%, P = 0.0008, respectively) and perampanel 4, 8, and 12 mg in the non‐Asian population (?35.07%, P = 0.0001; ?37.78%, P < 0.0001; ?34.53%, P < 0.0001, respectively). In both populations, median percentage change in GTC seizure frequency was significantly greater for perampanel 8 mg than placebo (median difference from placebo: Asian, ?37.37%, P = 0.0139; non‐Asian, ?27.04%, P = 0.0006). The 50% responder rates were significantly greater than placebo for perampanel 8 and 12 mg for FBTC seizures (Asian: 58.0%, P = 0.0017 and 58.6%, P = 0.0013, respectively; non‐Asian: 59.3%, P < 0.0001 and 54.3%, P = 0.0050, respectively) and perampanel 8 mg for GTC seizures (Asian: 57.6%, P = 0.0209; non‐Asian: 68.8%, P = 0.0329). Pooled FBTC/GTC seizure data showed generally similar patterns of response to perampanel in both populations. The most frequent treatment‐related adverse events were fatigue, irritability, dizziness, somnolence, and headache. Perampanel was effective, well tolerated, and can be considered a therapeutic option for FBTC/GTC seizures in Asian populations.     

Criterion validity of the GMFM‐66 item set and the GMFM‐66 basal and ceiling approaches for estimating GMFM‐66 scores

Aim

The aim of this study was to compare the accuracy of two abbreviated approaches for estimating Gross Motor Function Measure 66 (GMFM‐66) scores against the full GMFM‐66 and to explore their strengths and limitations.

Method

An existing dataset (n=224) comprising children aged 1 to 13 years (mean age 6y 11mo, SD 4y 6mo; 132 males, 92 females) with cerebral palsy (CP) of all Gross Motor Function Classification System (GMFCS) levels was used to compare the validity of the item set version (GMFM‐66‐IS) and the basal and ceiling version (GMFM‐66‐B&C) with the full GMFM‐66 scores. Follow‐up assessment at 1 year (n=109) allowed evaluation of change scores and accuracy at a single point in time.

Results

The cross‐sectional agreement was excellent for both abbreviated measures (all intraclass correlation coefficients [ICCs] >0.98). When measuring change over time, both the GMFM‐66‐IS and the GMFM‐66‐B&C showed good agreement for children with bilateral CP (ICCs >0.9). However, the GMFM‐66‐IS assessed change over 1 year more accurately than the GMFM‐66‐B&C in children with unilateral CP (ICC=0.89 vs ICC=0.58; 95% confidence intervals do not overlap).

Interpretation

Both approaches for estimating GMFM‐66 scores are accurate at a single point in time. If the primary goal of assessment is to measure change, the full GMFM‐66 should still be regarded as the criterion standard. The GMFM‐66‐IS should be the preferred shortened measure for children with unilateral CP.     

Cerebral venous sinus thrombosis complicated with acute development of dural arteriovenous fistula: A case report

Development of dural arteriovenous fistula (dAVF) after cerebral venous sinus thrombosis (CVST) was very uncommon and for all these reported cases, the dAVF was a chronic complication. We present a case of acute development of dAVF after CVST. A 40-year-old female was admitted into our department with 2 day’s headache and vomiting for 9 h. Head computed tomography (CT) scan showed only scattered minor hematomas over the right frontal lobe. Blood test indicated an elevated D-dimer. The patient experienced transient paralysis (Todd’s paralysis) after intermittent focal epilepsy from day 3, which progressed into sustained epilepsy on day 6. Magnetic resonance imaging (MRI) on day 7 confirmed the thrombosis of the superior sagittal sinus and a large area of infarction and edema in the left frontal and parietal lobe. She was then treated with heparin and warfarin. Cerebral angiography on day 9 demonstrated a dAVF which was classified as Borden Type II and fed by the left occipital artery. Subsequently, endovascular occlusion of the fistula was conducted and the patient recovered well with only slight right limbs weakness at 1 year follow up.     

Loneliness and cardiovascular disease and the role of late‐life depression

Objective

Loneliness and depression have a strong reciprocal influence, and both predict adverse health outcomes at old age. Therefore, this study examines whether loneliness is associated with the presence of cardiovascular diseases taking into account the role of late‐life depression.

Methods

Cross‐sectional data of 477 older adults in the Netherlands Study of Depressed Older Persons were used. Logistic regression analysis was performed to examine the relation between loneliness and cardiovascular disease. Depression was added to the regression model to examine whether depression is an explanatory factor in the association between loneliness and cardiovascular disease. Interaction terms between loneliness and depression and between loneliness and sex were introduced in the regression model to investigate whether depressed and non‐depressed participants, and men and women differed in their association between loneliness and cardiovascular disease.

Results

Of the overall group, 61% were lonely, 28% had a history of cardiovascular disease and 74% were depressed. Loneliness and cardiovascular disease were not associated in the overall group after adjustment for confounders (continuous: odds ratio [OR] = 1.04, 95% confidence interval [CI] = 0.98–1.10), p = 0.25; dichotomous: OR = 1.27, 95% CI = 0.80–2.03, p = 0.32). For women, there was an association between loneliness and cardiovascular diseases (continuous: OR = 1.13, 95% CI = 1.06–1.21, p < 0.001; dichotomous: OR = 2.64, 95% CI = 1.50–4.65, p = 0.001), but this association was not present in men (OR = 0.96, 95% CI = 0.88–1.05, p = 0.38). This association remained significant after adjustment for confounders, but it lost significance after adding depression to the model.

Conclusion

For women only, there was an association between loneliness and cardiovascular disease. However, this association was explained by depression, indicating that loneliness in its own right seems not related with cardiovascular disease. Copyright © 2017 John Wiley & Sons, Ltd.     

Evaluation of the implementation of the Meeting Centres Support Program in Italy,Poland, and the UK; exploration of the effects on people with dementia

Objectives

MEETINGDEM investigated whether the Dutch Meeting Centres Support Programme (MCSP) could be implemented in Italy, Poland, and the UK with comparable benefits. This paper reports on the impact on people living with dementia attending pilot Meeting Centres in the 3 countries.

Methods

Nine pilot Meeting Centres (MCs) participated (Italy—5, Poland—2, UK—2). Effectiveness of MCSP was compared with Usual Care (UC) on outcomes measuring behavioural and psychological symptoms (NPI), depression (CSDD), and quality of life (DQoL, QOL‐AD), analysed by ANCOVAs in a 6‐month pre‐test/post‐test controlled trial.

Results

Pre/post data were collected for 85 people with dementia and 93 carers (MCSP) and 74 people with dementia /carer dyads' receiving UC. MCSP showed significant positive effects for DQoL [Self‐esteem (F = 4.8, P = 0.03); Positive Affect (F = 14.93, P < 0.00); Feelings of Belonging (F = 7.77, P = 0.01)] with medium and large effect sizes. Higher attendance levels correlated with greater neuropsychiatric symptom reduction (rho = 0.24, P = 0.03) and a greater increase in feelings of support (rho = 0.36, P = 0.001).

Conclusions

MCSPs showed significant wellbeing and health benefits compared with UC, building on the evidence of effectiveness from the Netherlands. In addition to the previously reported successful implementation of MCSP in Italy, Poland, and the UK, these findings suggest that further international dissemination of MCSP is recommended.