A family based tailored counselling to increase non-exercise physical activity in adults with a sedentary job and physical activity in their young children: design and methods of a year-long randomized controlled trial

Background. Epidemiological evidence suggests that decrease in sedentary behaviour is beneficial for health. This family based randomized controlled trial examines whether face-to-face delivered counselling is effective in reducing sedentary time and improving health in adults and increasing moderate-to-vigorous activities in children. Methods. The families are randomized after balancing socioeconomic and environmental factors in the Jyväskylä region, Finland. Inclusion criteria are: healthy men and women with children 3-8 years old, and having an occupation where they self-reportedly sit more than 50% of their work time and children in all-day day-care in kindergarten or in the first grade in primary school. Exclusion criteria are: body mass index > 35 kg/m2, self-reported chronic, long-term diseases, families with pregnant mother at baseline and children with disorders delaying motor development. From both adults and children accelerometer data is collected five times a year in one week periods. In addition, fasting blood samples for whole blood count and serum metabonomics, and diurnal heart rate variability for 3 days are assessed at baseline, 3, 6, 9, and 12 months follow-up from adults. Quadriceps and hamstring muscle activities providing detailed information on muscle inactivity will be used to realize the maximum potential effect of the intervention. Fundamental motor skills from children and body composition from adults will be measured at baseline, and at 6 and 12 months follow-up. Questionnaires of family-influence-model, health and physical activity, and dietary records are assessed. After the baseline measurements the intervention group will receive tailored counselling targeted to decrease sitting time by focusing on commute and work time. The counselling regarding leisure time is especially targeted to encourage toward family physical activities such as visiting playgrounds and non-built environments, where children can get diversified stimulation for play and practice fundamental of motor skills. The counselling will be reinforced during the first 6 months followed by a 6-month maintenance period. Discussion. If shown to be effective, this unique family based intervention to improve lifestyle behaviours in both adults and children can provide translational model for community use. This study can also provide knowledge whether the lifestyle changes are transformed into relevant biomarkers and self-reported health. Trial registration number. ISRCTN: ISRCTN28668090peerReviewe

Detection of partial-thickness supraspinatus tendon tears: is a single direct MR arthrography series in ABER position as accurate as conventional MR arthrography?

The purpose of this study was to retrospectively evaluate sensitivity and specificity of a single magnetic resonance (MR) arthrography series in abduction external rotation (ABER) position compared with conventional MR arthrography for detection of supraspinatus tendon tears, with arthroscopy as gold standard, and to assess interobserver variability. Institutional review board approval was obtained; informed consent was waived. MR arthrograms of 250 patients (170 men and 80 women; mean age, 36 years) were retrospectively and independently evaluated by three observers. Oblique coronal T1-weighted fat-suppressed images, proton density, and T2-weighted images and axial T1-weighted images and oblique sagittal T1-weighted fat-suppressed images were analyzed to detect supraspinatus tendon tears. Separately, a single T1-weighted fat-suppressed oblique axial series in ABER position was evaluated. Both protocols were scored randomly without knowledge of patients' clinical history and arthroscopy results. Tears were subclassified, based on articular surface integrity and extension (Lee classification). Interobserver agreement was assessed by kappa statistics for all patients. Ninety-two of 250 patients underwent arthroscopy; sensitivity and specificity of ABER and conventional MR arthrography were calculated and compared using paired McNemar test. Weighted kappa values of ABER and conventional MR arthrography were 0.48-0.65 and 0.60-0.67, respectively. According to arthroscopy, 69 of 92 patients had an intact cuff, and 23 patients had a cuff tear (16 partial thickness and seven full thickness). There were no statistically significant differences between ABER and conventional MR arthrography regarding sensitivity (48-61% and 52-70%, respectively) and specificity (80-94% and 91-95%). Sensitivity and specificity of a single T1-weighted series in ABER position and conventional MR arthrography are comparable for assessment of rotator cuff tear

Phase II study of two eribulin regimens in combination with erlotinib in patients (PTS) with previously treated advanced non-small cell lung cancer (NSCLC)

This journal suppl. entitled: Abstract Book of the 37th ESMO Congress ... 2012BACKGROUND: Eribulin, a microtubule dynamics inhibitor, is approved for pts with locally advanced/metastatic breast cancer that progressed after ≥2 chemotherapeutic regimens for advanced disease. Prior therapy should have included an anthracycline and taxane unless not suitable. This randomized, multicenter study compared efficacy and tolerability of two eribulin regimens administered sequentially with erlotinib in pts with advanced NSCLC to establish an optimal dosing schedule. METHODS: Pts (ECOG ≤2; ≥1 prior anti-cancer therapy for advanced NSCLC including ≥1 platinum-based therapy) received 2.0 mg/m2 eribulin mesilate (2-5 min IV) on Day (D) 1 and 150 mg oral erlotinib on D2-16 (21D cycle), or 1.4 mg/m2 eribulin mesilate on D1 and D8 and 150 mg erlotinib on D15-28 (28D cycle). Primary endpoint was objective response rate (ORR); secondary endpoints were progression-free survival (PFS), overall survival (OS), disease control rate (DCR), safety, pharmacokinetics and biomarker (BM) assessment. RESULTS: 123 pts were treated (63 pts 21D cycle, 60 pts 28D cycle). Median age was 63 years (range 35-87), 53.7% male, 75.6% smokers, 65.9% stage IV disease and 91.1% ≥2 prior therapy for advanced NSCLC. ORR was 12.7% (21D) and 16.7% (28D); other efficacy parameters were also greater with the 28D cycle. Concomitant administration of erlotinib did not affect eribulin exposure and was well tolerated with no unexpected toxicities. BM analysis supported overall results. CONCLUSIONS: Both regimens were associated with moderate activity in this heavily pre-treated population. The 28D regimen appears to have greater activity and less toxicity than the 21D. Disclosure: S. Thongprasert: The author declares the following conflicts of interest: consultant/advisory role (Novartis/Pfizer/Eli Lilly), honoraria (AstraZeneca/Roche), and research funding (Novartis/Pfizer/Roche). D. Smith: The author declares the following conflicts of interest: research funding (Eisai). P. Gopalakrishna: The author declares the following conflicts of interest: employee (Eisai Ltd. C. Reynolds: The author declares the following conflicts of interest: honoraria/speakers bureau (Eisai). T.S.K. Mok: Consultant/advisory role (AstraZeneca /Pfizer/Eli Lilly/Roche/Merck Serono/Eisai/BMS/BeiGene/AVEO/Taiho/BI), honoraria (AstraZeneca/Roche Pfizer/Eli Lilly/ Merck Serono/Eisai/BMS/BeiGene/AVEO /Taiho/BI), research funding (AstraZeneca). All other authors have declared no conflicts of interest

Deltoid, triceps, or both responses improve the success rate of the interscalene catheter surgical block compared with the biceps response

BACKGROUND: The influence of the muscular response elicited by neurostimulation on the success rate of interscalene block using a catheter (ISC) is unknown. In this investigation, we compared the success rate of ISC placement as indicated by biceps or deltoid, triceps, or both twitches. METHODS: Three hundred (ASA I-II) patients presenting for elective arthroscopic rotator cuff repair were prospectively randomized to assessment by biceps (Group B) or deltoid, triceps, or both twitches (Group DT). All ISCs were placed with the aid of neurostimulation. The tip of the stimulating needle was placed after disappearance of either biceps or deltoid, triceps, or both twitches at 0.3 mA. The catheter was advanced 2-3 cm past the tip of the needle and the block was performed using 40 ml ropivacaine 0.5%. Successful block was defined as sensory block of the supraclavicular nerve and sensory and motor block involving the axillary, radial, median, and musculocutaneous nerves within 30 min. RESULTS: Success rate was 98.6% in Group DT compared with 92.5% in Group B (95% confidence interval 0.01-0.11; P<0.02). Supplemental analgesics during handling of the posterior part of the shoulder capsule were needed in two patients in Group DT and seven patients in Group B. Three patients in Group B had an incomplete radial nerve distribution anaesthesia necessitating general anaesthesia. One patient in Group B had an incomplete posterior block extension of the supraclavicular nerve. No acute or late complications were observed. CONCLUSIONS: Eliciting deltoid, triceps, or both twitches was associated with a higher success rate compared with eliciting biceps twitches during continuous interscalene block