Clinical Relevant Improvement Research Articles

Systematic Review of Vitamin D and Hypertensive Disorders of Pregnancy

This narrative systematic review evaluates growing evidence of an association between low maternal vitamin D status and increased risk of hypertensive disorders. The inclusion of interventional, observational, and dietary studies on vitamin D and all hypertensive disorders of pregnancy is a novel aspect of this review, providing a unique contribution to an intensively-researched area that still lacks a definitive conclusion. To date, trial evidence supports a protective effect of combined vitamin D and calcium supplementation against preeclampsia. Conflicting data for an association of vitamin D with gestational hypertensive disorders in observational studies arises from a number of sources, including large heterogeneity between study designs, lack of adherence to standardized perinatal outcome definitions, variable quality of analytical data for 25-hydroxyvitamin D (25(OH)D), and inconsistent data reporting of vitamin D status. While evidence does appear to lean towards an increased risk of gestational hypertensive disorders at 25(OH)D concentrations <50 nmol/L, caution should be exercised with dosing in trials, given the lack of data on long-term safety. The possibility that a fairly narrow target range for circulating 25(OH)D for achievement of clinically-relevant improvements requires further exploration. As hypertension alone, and not preeclampsia specifically, limits intrauterine growth, evaluation of the relationship between vitamin D status and all terms of hypertension in pregnancy is a clinically relevant area for research and should be prioritised in future randomised trials.

Melatonin Effects in REM Sleep Behavior Disorder Associated with Obstructive Sleep Apnea Syndrome: A Case Series.

REM sleep behavior disorder (RBD), with its main clinical symptoms of nightmares with dream-enacting behavior, is considered as a possible precursor of neurodegenerative disease. Obstructive Sleep Apnea Syndrome (OSAS) is known to be capable of provoking RBD-like symptoms by apneic event related arousals. The two sleep related pathologies must coincide in a relevant number of individuals because of overlapping prevalence in similar age groups. Until now RBD symptoms coexisting with OSAS are rarely described in scientific literature and in fact considered as OSAS mimicking RBD. We report four cases with a severe clinical RBD syndrome which were polysomnographically also diagnosed with concomitant OSAS (AHI range: 10.1 -53.2/h). Treatment with 2 mg prolonged release melatonin led to a relevant clinical improvement of RBD symptoms in all patients, so far untreated for the sleep related breathing disorder. Measure of REM sleep without atonia (RSWA) in polysomnography showed values ranging from 5.1 to 20.4% determined with the Montplaisir method. Surprisingly, RSWA values in PSG with melatonin were high, probably because of the still untreated OSAS. We presume that in patients with RBD and OSAS both pathologies contribute in varying degrees to the emergence of RBD symptoms by a destabilization of REM sleep. We suggest by consequence to consider a therapeutic strategy including the treatment of both disorders for an optimal therapeutic response.

Associations between changes in knee pain location and clinical symptoms in people with medial knee osteoarthritis using footwear for self-management: an exploratory study.

To examine whether change in pain location is associated with clinically-relevant improvements in walking pain severity and physical dysfunction in people with medial tibiofemoral osteoarthritis (OA) using footwear for self-management. We analysed a sub-set of 91 participants pooled from both arms of a 6-month randomised controlled trial of footwear for knee OA. The Photographic Knee Pain Map was self-administered to generate changes in the number of painful zones ('unchanged', 'increased', 'decreased') and anatomical patterns of pain ('unchanged', 'no longer diffuse', 'becoming diffuse', 'other pattern changes'). Improvement in symptoms was determined using the minimum clinically important differences (MCIDs) in pain severity on a numeric rating scale, and function with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Fisher's exact tests examined differences in symptom improvement across categories of change and odds ratios (ORs, 95% CI) were calculated (adjusted for treatment allocation). Seventy-four percent (n=67) of participants reported a change in pain location, and 46-50% (n=42-45) reported clinically-relevant improvements in pain and function respectively. Fewer participants 'becoming diffuse' reported improved pain (n=0, 0%) when compared to the other pattern change categories (P=0.012). Participants with 'no longer diffuse' (OR (95% CI)=0.3 (0.1-0.9) or 'becoming diffuse' (OR (95% CI)=0.0 (0.0-0.4) pain patterns had significantly lower odds of improved function than those with 'other pattern changes'. Participants either developing into, or changing from, diffuse pain patterns were less likely to experience improvement in pain and/or function when self-managing with footwear.

PUB093 A Prospective Study on Quality of Life among Persons with Lung Cancer, before and after the Chemotherapy Treatment - Evidence from South India

Lung cancer is usually diagnosed at an advanced stage and survival has not improved in spite of several therapeutic advancements. Since most patients depend on palliative care, it is imperative to evaluate and maintain a satisfactory quality of life in them. This prospective study aimed to assess the quality of life related to health (QLRH) of patients attending a tertiary care hospital with lung cancer after chemotherapy treatment. The QLRH was assessed using the questionnaires Quality-of-Life Questionnaire-Core 30 (QLQ-C30) and Lung Cancer Module (LC13), version 3.0 among the patients attending a Tertiary care hospital in mangalore. The sample was made up of 11 women and 19 men, with an average age of 68 years (51-87 years). After the chemotherapy treatment, the authors observed a clinically-relevant improvement in general quality of life, as well as in the symptoms of dyspnoea, insomnia, haemoptysis, cough, thoracic pain, pain in the arm/shoulder, and financial difficulty. There was a worsening on the functional scale which assesses role performance and symptoms of fatigue, nausea and vomiting, sensory neuropathy, pain in other parts, constipation, loss of appetite and alopecia. Although the patients have an improvement of their QLRH and symptoms related to the lung cancer after the chemotherapy treatment, there was a worsening of the symptoms which resulted from the toxicity of the chemotherapy medications.

Clinical and radiological outcome following pneumothorax after endoscopic lung volume reduction with valves.

IntroductionValve implantation has evolved as a therapy for patients with advanced emphysema. Although it is a minimally invasive treatment, it is associated with complications, the most common being pneumothorax. Pneumothorax occurs due to the rapid target lobe volume reduction and may be a predictor of clinical benefit despite this complication.ObjectiveThe objective of this study was to conduct an exploratory data analysis of patients who developed a pneumothorax following endoscopic valve therapy for emphysema.Materials and methodsThis study performed a retrospective evaluation of pneumothorax management and the impact of pneumothorax on clinical outcomes in 70 patients following valve therapy in 381 consecutive patients.ResultsPneumothorax rate following valve therapy was 18%. Pneumothorax management consisted of chest tube insertion, valve removal, and surgical intervention in 87% (61/70), 44% (31/70), and 19% (13/70) of the patients, respectively. Despite pneumothorax, patients experienced modest but significant improvements in lung function parameters (forced expiratory volume in 1 second: 55±148 mL, residual volume: −390±964 mL, total lung capacity: −348±876; all P<0.05). Persistent lobar atelectasis 3 months after recovering from pneumothorax, which was associated with relevant clinical improvement, was observed in only 21% (15/70) of the patients.ConclusionPneumothorax is a frequent severe complication following valve therapy that requires further intervention. Nevertheless, the pneumothorax does not impair the clinical status in the majority of patients. Patients with lobar atelectasis benefit after recovering from pneumothorax in terms of lung function parameters.

The effect of renal transplantation on quality of sleep in former dialysis patients.

Data on sleep quality in renal transplanted (RTX) patients are scarce, and longitudinal studies are lacking. The purpose of this study was to assess the prevalence of sleep complaints in RTX patients and identify variables associated with improvement in sleep quality. In a longitudinal study, 301 dialysis patients were followed for up to 5.5 years, during which time 142 were transplanted. Out of the transplanted patients, a total of 110 were eligible for inclusion. Sleep quality and depression were assessed with the validated questionnaires Pittsburgh Sleep Quality Index (PSQI) and Beck Depression Inventory (BDI), and data were collected during dialysis and after RTX. Based on PSQI scores, 59% were characterized as poor sleepers after RTX compared to 75% when in dialysis (P = 0.016). A total of 46% experienced a clinical relevant improvement in overall sleep quality, while 21% experienced a clinical relevant deterioration. In multivariable analyses, clinical meaningful change in sleep quality was not associated with either depressive symptoms assessed with BDI or other clinical variables. Sleep quality improved after RTX in nearly half of the patients, but poor sleep quality was prevalent in RTX patients. Therefore, sleep quality should routinely be assessed in RTX patients.

Cut-Offs and Response Criteria for the Hospital Universitario La Princesa Index (HUPI) and Their Comparison to Widely-Used Indices of Disease Activity in Rheumatoid Arthritis.

ObjectiveTo estimate cut-off points and to establish response criteria for the Hospital Universitario La Princesa Index (HUPI) in patients with chronic polyarthritis.MethodsTwo cohorts, one of early arthritis (Princesa Early Arthritis Register Longitudinal [PEARL] study) and other of long-term rheumatoid arthritis (Estudio de la Morbilidad y Expresión Clínica de la Artritis Reumatoide [EMECAR]) including altogether 1200 patients were used to determine cut-off values for remission, and for low, moderate and high activity through receiver operating curve (ROC) analysis. The areas under ROC (AUC) were compared to those of validated indexes (SDAI, CDAI, DAS28). ROC analysis was also applied to establish minimal and relevant clinical improvement for HUPI.ResultsThe best cut-off points for HUPI are 2, 5 and 9, classifying RA activity as remission if ≤2, low disease activity if >2 and ≤5), moderate if >5 and <9 and high if ≥9. HUPI’s AUC to discriminate between low-moderate activity was 0.909 and between moderate-high activity 0.887. DAS28’s AUCs were 0.887 and 0.846, respectively; both indices had higher accuracy than SDAI (AUCs: 0.832 and 0.756) and CDAI (AUCs: 0.789 and 0.728). HUPI discriminates remission better than DAS28-ESR in early arthritis, but similarly to SDAI. The HUPI cut-off for minimal clinical improvement was established at 2 and for relevant clinical improvement at 4. Response criteria were established based on these cut-off values.ConclusionsThe cut-offs proposed for HUPI perform adequately in patients with either early or long term arthritis.

Implementing intelligent physical exercise training at the workplace: health effects among office workers-a randomized controlled trial.

The aim was to assess 1-year cardiovascular health effects of Intelligent Physical Exercise Training, IPET. Office workers from six companies were randomized 1:1 to a training group, TG (N=194) or a control group, CG (N=195). TG received 1-h supervised high intensity IPET every week within working hours for 1year, and was recommended to perform 30-min of moderate intensity physical activity 6days a week during leisure. The training program was based on baseline health check measures of cardiorespiratory fitness (CRF), body composition, blood pressure, blood profile, and musculoskeletal health. There were no baseline differences between groups. CRF assessed as VO2max in absolute values and relative to body weight was (mean±SD): 3.0±0.8l/min and 35.4±10.9ml/min/kg for females, 3.9±1.0l/min and 37.9±11.79ml/min/kg for males. Intention to treat analysis demonstrated a significant almost 5% increase in VO2max in TG compared with CG. A per protocol analysis of those with an adherence of≥70% demonstrated a significant increase in CRF of more than 10% compared with CG, and a significant reduction in systolic blood pressure (-5.3±13.7mm Hg) compared with CG. High intensity IPET combined with the recommendations of moderate intensity physical activity demonstrated significant clinical relevant improvements in CRF and systolic blood pressure. This underlines the effectiveness of health promotion by implementing physical exercise training at the workplace.

Prospects of immune checkpoint modulators in the treatment of glioblastoma.

Glioblastoma is the most common primary brain tumour in adults. Prognosis is poor: even with the current gold-standard first-line treatment—maximal safe resection and combination of radiotherapy with temozolomide chemotherapy—the median overall survival time is only approximately 15-17 months, because the tumour recurs in virtually all patients, and no commonly accepted standard treatment for recurrent disease exists. Several targeted agents have failed to improve patient outcomes in glioblastoma. Immunotherapy with immune checkpoint inhibitors such as ipilimumab, nivolumab, and pembrolizumab has provided relevant clinical improvements in other advanced tumours for which conventional therapies have had limited success, making immunotherapy an appealing strategy in glioblastoma. This Review summarizes current knowledge on immune checkpoint modulators and evaluates their potential role in glioblastoma on the basis of preclinical studies and emerging clinical data. Furthermore, we discuss challenges that need to be considered in the clinical development of drugs that target immune checkpoint pathways in glioblastoma, such as specific properties of the immune system in the CNS, issues with radiological response assessment, and potential interactions with established and emerging treatment strategies.

Gastric bypass in morbid obese patients is associated with reduction in adipose tissue inflammation via N-oleoylethanolamide (OEA)-mediated pathways.

Paradoxically, morbid obesity was suggested to protect from cardiovascular co-morbidities as compared to overweight/obese patients. We hypothesise that this paradox could be inferred to modulation of the "endocannabinoid" system on systemic and subcutaneous adipose tissue (SAT) inflammation. We designed a translational project including clinical and in vitro studies at Geneva University Hospital. Morbid obese subjects (n=11) were submitted to gastric bypass surgery (GBS) and followed up for one year (post-GBS). Insulin resistance and circulating and SAT levels of endocannabinoids, adipocytokines and CC chemokines were assessed pre- and post-GBS and compared to a control group of normal and overweight subjects (CTL) (n=20). In vitro cultures with 3T3-L1 adipocytes were used to validate findings from clinical results. Morbid obese subjects had baseline lower insulin sensitivity and higher hs-CRP, leptin, CCL5 and anandamide (AEA) levels as compared to CTL. GBS induced a massive weight and fat mass loss, improved insulin sensitivity and lipid profile, decreased C-reactive protein, leptin, and CCL2 levels. In SAT, increased expression of resistin, CCL2, CCL5 and tumour necrosis factor and reduced MGLL were shown in morbid obese patients pre-GBS when compared to CTL. GBS increased all endocannabinoids and reduced adipocytokines and CC chemokines. In morbid obese SAT, inverse correlations independent of body mass index were shown between palmitoylethanolamide (PEA) and N-oleoylethanolamide (OEA) levels and inflammatory molecules. In vitro, OEA inhibited CCL2 secretion from adipocytes via ERK1/2 activation. In conclusion, GBS was associated with relevant clinical, metabolic and inflammatory improvements, increasing endocannabinoid levels in SAT. OEA directly reduced CCL2 secretion via ERK1/2 activation in adipocytes.

Anti-vgkc Antibody-associated Limbic Encephalitis Presenting with Recurrent Catatonia

Limbic encephalitis is an inflammatory disorder, commonly characterized by psychiatric features and cognitive impairment. It used to be considered a rare disease, usually paraneoplastic, with poor prognosis. Recent findings of membrane-surface directed antibodies, including anti-VGKC (Voltage-Gated Potassium Channels) antibodies, showed a substantial proportion of cases with no association with any malignancy and better prognosis. A 56-year-old woman was admitted to the psychiatric ward in Nov/2007, with an acute onset of psychomotor retardation and agitation periods, apathy and nihilistic symptoms. She improved very slowly with lorazepam, clomipramine and quetiapine. In Jun/2014, she was admitted again to the psychiatric ward with acute onset of intense headache, confusion, insomnia, agitation and prejudice ideas. There was a clinical deterioration with mnesic deficits, catatonic stupor, autonomic dysfunction and seizures. Complementary exams revealed: ESR>120mm; hyponatraemia; acelular CSF with slightly elevated protein; EEG with slow base activity; Brain MRI with diffuse cortical atrophy and multiples subcortical hyperintensities of frontoparietal regions on FLAIR and T2 sequences; and positive anti-VGKC antibodies. Initially there was a poor transitory improvement with high-dose steroids and intravenous immunoglobulins. After 5 months, she did plasmapheresis with relevant clinical improvement. About 80% of anti-VGKC encephalitis patients have clinical improvement following prompt treatment. In this case, there was not as good improvement as initially expected probably because of the prolonged duration of disease prior to effective treatment. Given the good prognostic outcome with prompt initiation of immunotherapy, early recognition and diagnosis of this rare neuropsychiatric syndrome is crucial.

Effects of Cholinesterase Inhibitors in Cognition on Parkinson’s Disease Dementia: A Systematic Review and Meta-Analysis

Introduction: Dementia is frequently associated with Parkinson’s disease, especially in later stages. Efficacy of cholinesterase inhibitors (ChI) in Alzheimer’s dementia is well established. However, treatment with ChI in Parkinson’s disease dementia (PDD) remains controversial. The objective of this systematic review and meta-analysis was to assess the effects of ChI in PDD. Methods: A comprehensive literature search was performed in MEDLINE, EMBASE and Cochrane library up to March 2014 using the descriptors “Parkinson’s disease”, “dementia in Parkinson’s disease”, “cognition”, “acetylcholinesterase inhibitors”, “cholinesterase inhibitors”, “anticholinesterase agents”, “rivastigmine”, “donepezil” and “galantamine” (Pubmed search strategy). All randomized, doubleblinded, placebo-controlled trials that met the eligibility criteria and assessed the effects of ChI in PDD were considered for analysis. There were no restrictions regarding paper language. Summary effect-sizes were presented as standardized mean differences (SMD) and the pooled analysis was performed with a fixed-effects model. Outcomes considered for analysis were the Mini Mental Status Exam (MMSE) score and the cognition scale for evaluation of dementia ADAS-Cog. The degree of heterogeneity between included studies was assessed through the I2 test. Results: After a comprehensive search, 175 references were retrieved. From these, five randomized trials involving 946PDD subjects were included in the review. Four studies used donepezil and only one study used rivastigmine. The pooled analysis of five studies that assessed the effects of ChI in MMSE total score showed a SMD of 0.24 (CI 95% 0.11 - 0.38). Three studies considered the effects of ChI on Adas-Cog and the pooled results showed a SMD of 0.21 (CI 95% 0.07 - 0.35). There was no significant heterogeneity between the studies. Conclusions: The results of this systematic review and meta- analysis suggest that ChI improves cognitive impairment in PDD subjects. Despite statistically significant, the translation of these results into relevant clinical improvement should be taken with caution, as the studies did not address what would be considered a clinically significant result.

Superior Restoration of Health with Siltuximab Among Multicentric Castleman’s Disease Patients When Measured By SF-36

INTRODUCTIONSiltuximab (SylvantTM), a monoclonal antibody against interleukin-6, was recently approved in both US and EU for treatment of adult patients with Multicentric Castleman’s Disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. Information on MCD symptoms, functioning and well-being was gathered in a pivotal global registration study (MCD2001, Van Rhee 2014) with a general patient reported outcome (PRO) questionnaire: the Short Form-36 (SF-36, acute version 2), and other PRO measures.OBJECTIVESEvaluate the longitudinal impact of siltuximab on symptoms, functioning and well-being as measured by SF-36 when compared to placebo.METHODSMCD2001 was a randomized (2:1), double-blind, placebo-controlled, multicenter study to determine the safety and efficacy of siltuximab in patients with symptomatic MCD. Patients received siltuximab 11 mg/kg or placebo by intravenous infusion every 3 weeks in combination with best supportive care (BSC). Subjects (N = 79) completed the SF-36 at baseline and every three weeks throughout the treatment period; 1998 scoring weights were applied. Patients, whose baseline SF-36 domain scores were below the general population norm for their age group (n = 46) were included in an analysis to compare by treatment arm the proportion of patients achieving an SF-36 domain score equal to, or greater than, the population norm at final visit. This analysis, hereafter referred to as a return to general population health norms (RTN), was conducted separately for each SF-36 domain. It is regarded as clinically-relevant improvement (CRI) since disease control is the current treatment goal. Referent norms were based on the US general population SF-36 cohort from the Medical Outcomes Study (Ware et al 1998). An intent-to-treat analysis was applied where missing data were not imputed; data were censored at treatment discontinuation, including crossover. Odds ratio was calculated between the two treatment arms and statistically compared with the Fisher’s Exact test.RESULTSAt baseline the population demonstrated inferior health compared to general population across all SF-36 domains (Figure 1). The odds of siltuximab-treated patients for reaching RTN vs. placebo patients in the Vitality, Role-emotional and Social functioning domains are significant, with odds ratios of 5.3 (p=0.049), 5.5 (p=0.011) and 11.4 (p=0.014), respectively. A positive health trend was observed for patients who received siltuximab compared with placebo across all other domains, particularly Role-physical (5.5, p=0.067; Figure 2). Sensitivity analysis using a literature-based CRI supported the robustness of the results.CONCLUSIONOverall MCD patients reported notably inferior health compared to the general population at baseline; siltuximab significantly improved the odds for RTN versus placebo in the Role-emotional, Vitality and Social function domains, as well as demonstrated a trend to improve health across all other SF-36 domains among MCD patients who were below the norms at baseline. A clinically-relevant PRO benefit for physical and mental health was observed with siltuximab therapy, as measured with the SF-36, which supports the “disease control” treatment goal.ReferencesVan Rhee et al. Siltuximab for multicentric Castleman’s disease:a randomised, double-blind, placebo-controlled trial, Lancet Oncol, 2014, 15(9):966-74Teschendorf B et al. Development and Content Validation of a Multicentric Castleman’s Disease Symptom Scale; Value in Health, 2010, 13(7): A470Ware et al. SF-36v2 health survey: manual and interpretation guide. 1998 [Display omitted] [Display omitted] Disclosuresvan Rhee:Janssen: Membership on an entity’s Board of Directors or advisory committees; Celgene: Membership on an entity’s Board of Directors or advisory committees; Millenium: Membership on an entity’s Board of Directors or advisory committees; Sanofi: Membership on an entity’s Board of Directors or advisory committees. Casper:Janssen: Consultancy, Research Funding. Robinson:Johnson & Johnson: Employment, Stocks Other. He:Janssen: Employment, Equity Ownership. Vermeulen:Janssen Biologics: Employment, Equity Ownership, Honoraria. van de Velde:Janssen Research & Development: Employment, Equity Ownership. Wong:Johnson & Johnson: Honoraria, Membership on an entity’s Board of Directors or advisory committees, Research Funding; GlaxoSmithKline: Honoraria, Membership on an entity’s Board of Directors or advisory committees, Research Funding, Speakers Bureau; Pfizer: Research Funding; Biogen-Idec: Honoraria, Membership on an entity’s Board of Directors or advisory committees, Research Funding; Novartis: Honoraria, Membership on an entity’s Board of Directors or advisory committees, Research Funding, Speakers Bureau; Bayer: Honoraria, Membership on an entity’s Board of Directors or advisory committees, Research Funding.

Effects of Posteroanterior Lumbar Spine Mobilizations on Pain, Rom and Functional Disability in Female Subjects with Chronic Nonspecific

Background : Chronic nonspecific low back pain (CNSLBP) i.e., low back pain of at least 12 weeks duration with out a specific cause is a major cause of activity limitation, absenteeism , and high health care expenses. The prevalence of CNSLBP is estimated approximately 23% and activity limitation due to LBP have been found to be 11% to 12% of the population. Previous studies comparing the efficacy of postero-anterior mobilisation and prone-press ups were done and revealed statistically significant improvements in extension ranges but not clinical relevant improvements. This is possibly attributable to single session of interventions. So long term gains in pain reduction and lumbar extension cannot be assumed. Hence this study would be intending to prove the effect of postero-anterior mobilisation and prone press ups on chronic non-specific low back pain after 6 weeks and their clinical application. Method : 30 subjects who met the inclusion criteria were selected randomly from the department of physiotherapy, SVIMS and BIRRD, Tirupati. The study conducted for a period of 6 weeks.2 groups were formed with 15 in each group. PA lumbar glide and prone press up's was given to group I and only prone press up's was given to group II. Subjects were evaluated pre and post treatment for VAS, extension ROM of lumbar spine and functional disability. Result : Results showed that there exists a statistical significance between the groups in all the 3 parameters. Present randomized clinical trial provided evidence to support the use of postero-anterior mobilisation and prone press-ups in relieving pain, improving ROM and reducing disability in subjects with non-specific low back pain. In addition, results supported that postero-anterior mobilisation was more effective than prone press-ups.

Clinical outcome after reconstruction of the medial patellofemoral ligament in paediatric patients with recurrent patella instability.

Medial patellofemoral ligament (MPFL) reconstruction has recently been broadly accepted as primary surgical treatment in adults. Reconstruction techniques with osseous fixation in femur cannot be used for patients with open growth plates. Operative treatment of patella instability in children therefore is a challenge and requires alternative MPFL reconstruction techniques. Limited knowledge exists concerning outcome after MPFL reconstruction in children and adolescents. This study present clinical outcome in a consecutive single clinic series of children treated with paediatric MPFL reconstruction using a soft tissue femoral fixation technique. Twenty-four MPFL reconstructions in 20 operated children aged 8-16 were included in the study. Indication for surgery was two or more patella dislocations. MPFL reconstruction was performed by looping the released gracilis tendon around the adductor magnus tendon insertion and through drill holes in the proximal medial patella edge. Clinical outcome was evaluated by Kujala score and NRS pain score preoperatively, at 1-year follow-up and final follow-up at 39 months. Outcome was compared with a cohort of 179 adult patients with recurrent patella instability operated with an adult MPFL reconstruction technique. Kujala score improved from 61 (13) to 81 (16). NRS pain score improved from 3.0 (3.1) to 1.5 (1.3) in activity. Four patients (20%) experienced redislocation within the first postoperative year compared with 5% in an adult patient population. Five patients (25%) experienced subluxations. One patient with a redislocation was re-operated with adult MPFL reconstruction technique. Cartilage injury was seen in six patients. There are clinical relevant improvements in knee function and pain after MPFL reconstruction in paediatric patients. Patella stability after MPFL reconstruction using femoral soft tissue graft fixation in paediatric patients was inferior to MPFL reconstruction using bony femoral fixation in adult patients. Case-Control study, Level III.

P.8.b.022 Antiepileptic drugs and SSRIs in therapy of not being stopped pain syndrome in patients with gynecologic cancer

The experimental group was treated with autogenic therapy and the control group with supportive group psychotherapy. The respiratory function parameters Forced Vital Capacity (FVC), Forced Expiratory Volume in the first second (FEV1), Forced Expiratory Flow between 25% and 75% of the FVC (FEF25−75%), and Mesoexpiratory Flow (MEF50%) were conveniently measured. Comparisons between group scores were carried out by applying Student’s t-test. Results: The group under Autogenic Therapy obtained a relevant clinical improvement (>15% of pre-treatment values) in respiratory function parameters with a statistical significant improvement in nearly all of the respiratory parameters. Only MEF50 parameters didn’t reach a statistical difference. No significant statistical changes were observed in the control group. Conclusions: Autogenic therapy manifests effectiveness as an adjunctive treatment in bronchial asthma, achieving an important improvement in respiratory function, as evidenced in this study whereas supportive group psychotherapy does not achieve this improvement. The likely important changes induced by autogenic therapy in neurovegetative function may account for this relevant improvement as seen in these chronic asthmatic patients. The results suggest that autogenic therapy could be an effective adjunctive treatment in bronchial asthma.

Effect of Two Contrasting Interventions on Upper Limb Chronic Pain and Disability: A Randomized Controlled Trial

Background: Chronic pain and disability of the arm, shoulder, and hand severely affect labor market participation. Ergonomic training and education is the default strategy to reduce physical exposure and thereby prevent aggravation of pain. An alternative strategy could be to increase physical capacity of the worker by physical conditioning. Objectives: To investigate the effect of 2 contrasting interventions, conventional ergonomic training (usual care) versus resistance training, on pain and disability in individuals with upper limb chronic pain exposed to highly repetitive and forceful manual work. Study Design: Examiner-blinded, parallel-group randomized controlled trial with allocation concealment. Setting: Slaughterhouses located in Denmark, Europe. Methods: Sixty-six adults with chronic pain in the shoulder, elbow/forearm, or hand/wrist and work disability were randomly allocated to 10 weeks of specific resistance training for the shoulder, arm, and hand muscles for 3 x 10 minutes per week, or ergonomic training and education (usual care control group). Pain intensity (average of shoulder, arm, and hand, scale 0 – 10) was the primary outcome, and disability (Work module of DASH questionnaire) as well as isometric shoulder and wrist muscle strength were secondary outcomes. Results: Pain intensity, disability, and muscle strength improved more following resistance training than usual care (P &lt; 0.001, P = 0.05, P &lt; 0.0001, respectively). Pain intensity decreased by 1.5 points (95% confidence interval -2.0 to -0.9) following resistance training compared with usual care, corresponding to an effect size of 0.91 (Cohen’s d). Limitations: Blinding of participants is not possible in behavioral interventions. However, at baseline outcome expectations of the 2 interventions were similar. Conclusion: Resistance training at the workplace results in clinical relevant improvements in pain, disability, and muscle strength in adults with upper limb chronic pain exposed to highly repetitive and forceful manual work. Trial registration: NCT01671267. Key words: Musculoskeletal pain, workability, shoulder pain, elbow pain, tennis elbow, wrist pain

Ultrasound and contrast enhanced ultrasound sonography evaluation of intestinal acute graft-vs-host disease

SUMMARY Intestinal acute graft-vs-host disease (I-GVHD) is a life-threatening complication after allografting. Non-invasive bedside procedures to evaluate extension and treatment response are still lacking. Standard ultrasound sonography (US) detects bowel wall thickening (BWT) in I-GVHD and helps to identify its extension (single or multiple sites at once). Color doppler US detects blood flow at arterioles level. Contrast-enhanced ultrasound sonography (CEUS) can detect microcirculation changes (MVC) of the bowel wall at capillary level, real time, and even bedside. CEUS allows evaluating, with dedicated software, quantitatively wash-in and washout curves of blood flowing through the thickened bowel wall, giving time intensity curves, which help to monitor treatment response as for Chron’s disease. Patients with I-GVHD with clinical relevant improvement may still have quiescent active disease. CEUS allows identifying, qualitatively and quantitatively, patients with I-GVHD with clinical improvement but with still active disease.

Positive predictive factors and subgroup analysis of clinically relevant improvement after anterior cervical decompression and fusion for cervical disc disease: a 10- to 13-year follow-up of a prospective randomized study

The main purpose of this 10- to 13-year follow-up of a prospective randomized study was to identify preoperative factors that predicted good long-term outcome after anterior cervical decompression and fusion (ACDF) with the Cloward procedure or the cervical intervertebral fusion cage. A second purpose was to investigate subgroup differences at the 10-year follow-up between patients with and without clinically relevant improvement (CRI) and between men and women. To evaluate clinically meaningful outcomes, good outcome was defined as CRI in neck-related pain intensity (≥ 30-mm improvement on a visual analog scale), and CRI in neck-specific disability (≥ 20% improvement in the neck disability index [NDI]) from preoperative measurements to the 10-year follow-up. A total of 73 patients (77% of the original study sample) completed questionnaires at least 10 years after ACDF. High preoperative neck-related pain intensity and preoperative nonsmoking status were predictors of CRI in neck-related pain intensity, and male sex was a predictor of CRI in neck-specific disability; however, no additional predictive factors were identified for good outcome after ACDF. The surgical procedure, number of operated levels, and radiological factors such as healing status did not influence the prediction models. Individuals without CRI in neck-specific disability (75%) and pain intensity (43%) reported a worse outcome for several psychosocial outcome variables compared with those with CRI. At the 10-year follow-up, women reported significantly greater neck- and arm-related pain intensity than men, and women also reported more disability and worse psychosocial status. Women reported CRI on the NDI less frequently than men (p = 0.01). Preoperative predictive factors of good outcome 10-13 years after ACDF included initial high neck-related pain intensity, nonsmoking status at the time of surgery, and male sex. There were greater improvements in pain intensity than in neck-specific disability, and the latter showed a greater association with psychosocial factors. These results suggest the need for multimodal postoperative rehabilitation for patients who do not have a satisfactory outcome after ACDF.

Comparison of the quality of life among persons with lung cancer, before and after the chemotherapy treatment

this prospective study aimed to assess the quality of life related to health (QLRH) of patients with lung cancer after chemotherapy treatment. The QLRH was assessed using the questionnaires Quality-of-Life Questionnaire-Core 30 (QLQ-C30) and Lung Cancer Module (LC13), version 3.0. the sample was made up of 11 women and 19 men, with an average age of 68 years (51-87 years). After the chemotherapy treatment, the authors observed a clinically-relevant improvement in general quality of life, as well as in the symptoms of dyspnea, insomnia, hemoptysis, cough, thoracic pain, pain in the arm/shoulder, and financial difficulty. There was a worsening on the functional scale which assesses role performance and symptoms of fatigue, nausea and vomiting, sensory neuropathy, pain in other parts, constipation, loss of appetite and alopecia. although the patients have an improvement of their QLRH and symptoms related to the lung cancer after the chemotherapy treatment, there was a worsening of the symptoms which resulted from the toxicity of the chemotherapy medications.