Reported Outcome Variables Research Articles

Association Between Wearable Device Use and Levels of Physical Activity Among Older Adults in the US: Evidence From the 2019-2020 Health Information National Trends Survey.

Objective To examine the relationship between electronic wearable device (WD) use and physical activity (PA) levels among older adults in the US. Methods Data were pooled from 3310 older adults from the 2019 and 2020 Health Information National Trends Survey. The explanatory variable was WD use, and the outcomes were weekly PA levels, resistance training, and sedentary time. Logistic regression was conducted to investigate the association between WD use and the reported outcome variables. Separate logistic models were also fitted to explore the relationship between WD use and physical activity outcomes among a subgroup of older adults with chronic conditions. Results A total of 14.4% of older adults reported WD use. Older adults who use WD were more likely to meet national guidelines for weekly levels of PA (odds ratio(OR) 1.60, 95% confidence intervals (CI) (1.10, 2.32); p = 0.015) and resistance strength training (OR 1.54, 95% CI (1.14, 2.09); p = 0.005) when compared with their counterparts not using WD. After restricting the analysis to those with chronic conditions only, WD use was only associated with a higher level of weekly strength training (OR 1.68, 95% CI 1.19, 2.38; p = 0.004). Conclusion WD use may be associated with increased physical activity among older adults, including those with chronic health conditions. Further studies are needed to examine the factors influencing the adoption and sustained use of WD in older adults.

Cohort profile: the Swedish National Quality Register for bipolar disorder(BipoläR)

PurposeThe Swedish National Quality Register for bipolar affective disorder, BipoläR, was established in 2004 to provide nationwide indicators for quality assessment and development in the clinical care of individuals with...

POS0079 PATIENTS WITH JUVENILE SYSTEMIC SCLEROSIS HAVE A DISTINCT PATTERN OF ORGAN INVOLVEMENT.RESULTS FROM THE JUVENILE SYSTEMIC SCLEROSIS INCEPTION COHORT. WWW.JUVENILE-SCLERODERMA.COM

Background:Juvenile systemic sclerosis (jSSc) is a rare disease with a prevalence of around 3 in 1,000,000 children. To better capture the clinical manifestations of jSSc the juvenile systemic sclerosis inception cohort (jSScC) has been prospectively enrolling patients with predetermined clinical variables over the past 12 years. One of the goals is to study the demographic, clinical features, and physician and patient reported outcome differences between those with juvenile limited cutaneous (lc) compared to diffuse cutaneous (dc) disease subtypes, to determine if characteristics are similar or different between dc and lc jSSc.Objectives:Evaluation of the baseline clinical characteristics of jSSc patients in the jSScC. Compare clinical phenotype between diffuse (dcjSSc) and limited cutaneous (lcjSSc) subtypes.Methods:Demographic, physical examination, organ system evaluation, autoantibody profile, treatment, and patient and physician reported outcome variables were evaluated from the jSSc Inception cohort and summary statistics applied using chi-square test and Mann Whitney U-test comparing lcjSSc and dcjSSc subtypes.Results:At the time of data extraction, 175 jSSc patients were enrolled in the cohort, 81% were Caucasian and 81% female. Diffuse cutaneous jSSc subtype predominated (73%). Mean disease duration was 3.1 year (±2.7). Mean age at Raynaud´s was 10 years (+3.8) and mean age of first non-Raynaud´s was 10.2 years (±3.8). Significant differences were found between dcjSSc versus lcjSSc, regarding several clinical characteristics. Patients with diffuse cutaneous subtype had significantly higher modified Rodnan skin score (p=0.001), presence of sclerodactyly (p=0.02), presence of Gottron’s papules (p=0.003), presence of telangiectasia (p=0.001), history of digital tip ulceration (p=0.01), and frequency of elevated CK value (p=0.04). Cardiac involvement was significantly higher in limited cutaneous jSSc subtype (p=0.02). Diffuse cutaneous jSSc patients had significantly worse scores for Physician Global Assessment of disease activity (38 vs 25; p=0.002) and disease damage (34 vs 19; p=0.008).Table 1.Comparison of demographic data and significant differences between dcjSSc and lcjSSc at time of inclusionWhole CohortN=175Diffuse SubtypeN=128Limited SubtypeN=47P valueFemale to Male Ratio4.3:1 (142/33)4.1:1 (103/25)4.8:1 (39/8)0.829Cutaneous subtypeDiffuse subtype73% (128)1280Limited subtype27% (47)047Mean Disease duration (years)3.1 (± 2.7)3.3 (± 2.9)2.6 (± 2.2)0.135Mean age of onset of Raynaud´s (years)10.0 (± 3.8)17 non-Raynaud9.8 (± 3.6)10 non-Raynaud10.6 (± 4.3)7 non-Raynaud0.219Mean age of onset of non-Raynaud´s (years)10.2 (± 3.9)10.0 (± 3.7)10.9 (± 4.3)0.173Disease modifying drugs88% (154)89% (114)85% (40)0.446CutaneousMean modified Rodnan skin score14.3 (0-51)17.4 (0-51)6.1 (0-24)0.001Gottron Papules27% (46/171)33% (41/124)11% (5)0.003Sclerodactyly78% (126/162)82% (98/119)65% (28/43)0.020Laboratory valuesElevated CK25% (30/122)30% (26/88)12% (4/34)0.041VascularTelangiectasia36% (56/154)44% (49/111)16% (7/43)0.001History of ulceration53% (91/173)61% (77/127)30% (14/46)0.001CardiacCardiac Involvement6% (10)2% (3)15% (7)0.002Patient Related OutcomesPhysician global disease activity(0-100) min -max35(0-90) n=14138(0-90) n=10825(0-80) n=330.002Physician global disease damage(0-100) min -max31(0-85) n=14034(0-85) n=10819(0-60) n=320.008Conclusion:Results from this large international cohort of jSSc patients demonstrate significant differences between dcjSSc and lcjSSc patients. According to the general organ involvement and physician global scores, the dcjSSc patients had significantly more severe disease. These observations strengthen our previous findings of the unique organ pattern of pediatric patients.Supported by the “Joachim Herz Stiftung”Disclosure of Interests:None declared.

Learning curves of open and endoscopic fetal spina bifida closure: systematic review and meta-analysis.

The Management of Myelomeningocele Study (MOMS) trial demonstrated the safety and efficacy of open fetal surgery for spina bifida aperta (SBA). Recently developed alternative techniques may reduce maternal risks without compromising the fetal neuroprotective effects. The aim of this systematic review was to assess the learning curve (LC) of different fetal SBA closure techniques. MEDLINE, Web of Science, EMBASE, Scopus and Cochrane databases and the gray literature were searched to identify relevant articles on fetal surgery for SBA, without language restriction, published between January 1980 and October 2018. Identified studies were reviewed systematically and those reporting all consecutive procedures and with postnatal follow-up ≥ 12 months were selected. Studies were included only if they reported outcome variables necessary to measure the LC, as defined by fetal safety and efficacy. Two authors independently retrieved data, assessed the quality of the studies and categorized observations into blocks of 30 patients. For meta-analysis, data were pooled using a random-effects model when heterogeneous. To measure the LC, we used two complementary methods. In the group-splitting method, competency was defined when the procedure provided results comparable to those in the MOMS trial for 12 outcome variables representing the immediate surgical outcome, short-term neonatal neuroprotection and long-term neuroprotection at ≥ 12 months of age. Then, when raw patient data were available, we performed cumulative sum analysis based on a composite binary outcome defining successful surgery. The composite outcome combined four clinically relevant variables for safety (absence of extreme preterm delivery < 30 weeks, absence of fetal death ≤ 7 days after surgery) and efficacy (reversal of hindbrain herniation and absence of any neonatal treatment of dehiscence or cerebrospinal fluid leakage at the closure site). Of 6024 search results, 17 (0.3%) studies were included, all of which had low, moderate or unclear risk of bias. Fetal SBA closure was performed using standard hysterotomy (11 studies), mini-hysterotomy (one study) or fetoscopy by either exteriorized-uterus single-layer closure (one study), percutaneous single-layer closure (three studies) or percutaneous two-layer closure (one study). Only outcomes for standard hysterotomy could be meta-analyzed. Overall, outcomes improved significantly with experience. Competency was reached after 35 consecutive cases for standard hysterotomy and was predicted to be achieved after ≥ 57 cases for mini-hysterotomy and ≥ 56 for percutaneous two-layer fetoscopy. For percutaneous and exteriorized-uterus single-layer fetoscopy, competency was not reached in the 81 and 28 cases available for analysis, respectively, and LC prediction analysis could not be performed. The number of cases operated is correlated with the outcome of fetal SBA closure, and the number of operated cases required to reach competency ranges from 35 for standard hysterotomy to ≥ 56-57 for minimally invasive modifications. Our observations provide important information for institutions looking to establish a new fetal center, develop a new fetal surgery technique or train their team, and inform referring clinicians, potential patients and third parties. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd.

Danish policymakers and research evidence in public health policy process

Abstract Background Evidence-informed policymaking in public health, understood as interaction of the best available research evidence and “other types of evidence”, is known to have sound influence on population well-being. However, lack of using and producing research evidence by public health policymakers has been well documented. The aim of this study was to assess policymakers’ research involvement in the research process as well as motivators and barriers for the use and production of research evidence. Methods A cross-sectional online survey was carried out in the period of Dec 2018 - Jan 2019 using a pre-tested, self-administrated questionnaire. Participants were Danish policymakers’ members of the Danish Society of Public Health (DSPH) and with practical experience being involved in a health policy-making process. The questionnaire was distributed through the DSPH members email list. Reported outcome variables; for this abstract are parts of the larger study: health policymakers’ research involvement in the last 12Mo; policymakers’ motivators and barriers to use and produce research in policy-making. Results Response rate: 100/480 (15%). 78% were involved in critical evaluation of research for policy-making; 77% were able to identify relevant research literature; 41% did not use research evidence; 40% did not conduct any surveys; 57% did not write research reports; 65% never used reference systems; 46% did not analyze any research data. The three motivators reported to use and produce research in the last 12Mo were: identification of the problem that needs to be addressed; development of research skills; and job satisfaction. The three main barriers were: other job-related priorities; lack of time for research; lack of research funding. Conclusions This study reinforced that public health policymakers need more practical knowledge and skills as well as organizational support and management to use and produce research evidence for evidence-informed policy-making. Key messages Successful evidence-informed policymaking requires capacity-building interventions targeting policymakers, supported, implemented and evaluated by their organizations. Policymakers do not dismiss evidence-informed policy practice, but their “positions” and conditions at a work place sometimes do not allow them to fully follow it.

Systematic review and meta-analysis of gait mechanics in young and older adults

BackgroundAge-related gait changes may play a critical role in functional limitations of older adults. Despite sizable interest in determining how age alters walking mechanics, small sample sizes and varied outcome measures have precluded a comprehensive understanding of the impact of age on lower extremity joint kinematics and kinetics. ObjectiveThe aim of this study was to perform a systematic review and meta-analysis of the aging gait mechanics literature. MethodsThe overall standardized effect of age on walking mechanics was computed for 29 studies (200 standardized effects). To account for variation in reported outcome variables, analyses were carried out for comparisons between young and older adult results using all discrete kinematic or kinetic variables reported for the ankle, knee, or hip. Different variables reported for a given joint were then analyzed as separate categorical moderators. ResultsThe overall standardized effect of age was large for ground reaction forces, moderate for ankle and small for knee and hip kinematics and ankle and hip kinetics. When the analysis was restricted to studies with similar or matched walking speed, the standardized effects of age remained similar except for hip power generation and knee kinematic variables. ConclusionsThe results of this meta-analysis provide evidence to support moderate standardized effects, with and without consideration of walking speeds, for changes in lower extremity kinematics, joint moments and powers at the ankle, and ground reaction forces. The standardized effects of age for knee mechanics are less conclusive and would benefit from further research.

Variation in population levels of physical activity in European adults according to cross-European studies: a systematic literature review within DEDIPAC.

BackgroundPhysical inactivity is a well-known public health risk that should be monitored at the population level. Physical activity levels are often surveyed across Europe. This systematic literature review aims to provide an overview of all existing cross-European studies that assess physical activity in European adults, describe the variation in population levels according to these studies, and discuss the impact of the assessment methods.MethodsSix literature databases (PubMed, EMBASE, CINAHL, PsycINFO, SportDiscus and OpenGrey) were searched, supplemented with backward- and forward tracking and searching authors’ and experts’ literature databases. Articles were included if they reported on observational studies measuring total physical activity and/or physical activity in leisure time in the general population in two or more European countries. Each record was reviewed, extracted and assessed by two independent researchers and disagreements were resolved by a third researcher. The review protocol of this review is registered in the PROSPERO database under registration number CRD42014010334.ResultsOf the 9,756 unique identified articles, twenty-five were included in this review, reporting on sixteen different studies, including 2 to 35 countries and 321 to 274,740 participants. All but two of the studies used questionnaires to assess physical activity, with the majority of studies using the IPAQ-short questionnaire. The remaining studies used accelerometers. The percentage of participants who either were or were not meeting the physical activity recommendations was the most commonly reported outcome variable, with the percentage of participants meeting the recommendations ranging from 7 % to 96 % across studies and countries.ConclusionsThe included studies showed substantial variation in the assessment methods, reported outcome variables and, consequently, the presented physical activity levels. Because of this, absolute population levels of physical activity in European adults are currently unknown. However, when ranking countries, Ireland, Italy, Malta, Portugal, and Spain generally appear to be among the less active countries. Objective data of adults across Europe is currently limited. These findings highlight the need for standardisation of the measurement methods, as well as cross-European monitoring of physical activity levels.Electronic supplementary materialThe online version of this article (doi:10.1186/s12966-016-0398-2) contains supplementary material, which is available to authorized users.

Statistically Non-significant Papers in Environmental Health Studies included more Outcome Variables

ObjectiveThe number of analyzed outcome variables is important in the statistical analysis and interpretation of research findings. This study investigated published papers in the field of environmental health studies. We aimed to examine whether differences in the number of reported outcome variables exist between papers with non-significant findings compared to those with significant findings. Articles on the maternal exposure to mercury and child development were used as examples. MethodsArticles published between 1995 and 2013 focusing on the relationships between maternal exposure to mercury and child development were collected from Medline and Scopus. ResultsOf 87 extracted papers, 73 used statistical significance testing and 38 (43.7%) of these reported ‘non-significant’ (P>0.05) findings. The median number of child development outcome variables in papers reporting ‘significant’ (n=35) and ‘non-significant’ (n=38) results was 4 versus 7, respectively (Mann-Whitney test P-value=0.014). An elevated number of outcome variables was especially found in papers reporting non-significant associations between maternal mercury and outcomes when mercury was the only analyzed exposure variable. ConclusionAuthors often report analyzed health outcome variables based on their P-values rather than on stated primary research questions. Such a practice probably skews the research evidence.

What is the current optimal fat grafting processing technique? A systematic review.

With the advents of new processing techniques and new graft survival theories in fat grafting, the question is: Which processing technique is of preference? This study systematically reviewed literature regarding current techniques for processing fat grafts. PubMed, Embase, Cinahl, and Cochrane databases were searched until August 2015. Studies comparing different fat grafting processing techniques were included. Outcomes were viability of adipocytes, number of adipose-derived stromal/stem cells (ASC) and growth factors in vitro, volume and quality of the graft in animal studies, and satisfaction and volume retention in human studies. Thirty-five studies were included. Adipocyte viability and ASC numbers were the best using the gauze/towel technique (permeability principle) compared to centrifugation. With regard to centrifugation, the pellet contained more ASCs compared to the middle layer. The animal studies' and patients' satisfaction results were not distinctive. The only study assessing volume retention in humans showed that a wash filter device performed significantly better than centrifugation. In this study, processing techniques using permeability principles proved superior to centrifugation (reinforced gravity principle) regarding viability and ASC number. Due to the variety in study characteristics and reported outcome variables, however, none of the processing techniques in this study demonstrated clinical evidence of superiority.

THU0258 The RAID Questionnaire and Other Patient Reported Outcome Variables Are Highly Influenced by the Degree of Pain Catastrophizing, in Contrast to Ultrasound, Clinical and Laboratory Variables; Results from A Follow-Up Study of Patients with Established RA

BackgroundThe Rheumatoid Arthritis (RA) Impact of Disease (RAID) score is a patient developed questionnaire including 7 questions (pain, functional capacity, fatigue, physical and emotional wellbeing, quality of sleep and coping)...

Nursing unit teams matter: Impact of unit-level nurse practice environment, nurse work characteristics, and burnout on nurse reported job outcomes, and quality of care, and patient adverse events—A cross-sectional survey

AimTo investigate the impact of nurse practice environment factors, nurse work characteristics, and burnout on nurse reported job outcomes, quality of care, and patient adverse events variables at the nursing unit level. BackgroundNurse practice environment studies show growing insights and knowledge about determining factors for nurse workforce stability, quality of care, and patient safety. Until now, international studies have primarily focused on variability at the hospital level; however, insights at the nursing unit level can reveal key factors in the nurse practice environment. DesignA cross-sectional design with a survey. MethodIn a cross-sectional survey, a sample of 1108 nurses assigned to 96 nursing units completed a structured questionnaire composed of various validated instruments measuring nurse practice environment factors, nurse work characteristics, burnout, nurse reported job outcomes, quality of care, and patient adverse events. Associations between the variables were examined using multilevel modelling techniques. ResultsVarious unit-level associations (simple models) were identified between nurse practice environment factors, nurse work characteristics, burnout dimensions, and nurse reported outcome variables. Multiple multilevel models showed various independent variables such as nursing management at the unit level, social capital, emotional exhaustion, and depersonalization as important predictors of nurse reported outcome variables such job satisfaction, turnover intentions, quality of care (at the unit, the last shift, and in the hospital within the last year), patient and family complaints, patient and family verbal abuse, patient falls, nosocomial infections, and medications errors. ConclusionResults suggested a stable nurse work force, with the capability to achieve superior quality and patient safety outcomes, is associated with unit-level favourable perceptions of nurse work environment factors, workload, decision latitude, and social capital, as well low levels of burnout. Nurses, physicians, nursing leaders, and executives share responsibility to create an environment supportive of interdisciplinary team development.

Pulse Pamidronate therapy in NSAID refractory ankylosing spondylitis. Is it effective?–An open label study

Objective To assess the efficacy of pulse Pamidronate therapy in NSAID refractory ankylosing spondylitis (AS). Patients Fifty two patients of ankylosing spondylitis (fulfilling modified New York criteria), refractory to NSAID and having active disease were enrolled. Active disease was defined as BASDAI = 4 and/or early morning stiffness = 45 minutes despite NSAID therapy. Intervention Monthly intravenous Pamidronate infusions (60 mg) for a period of 6 months along with current NSAID. Primary outcome measure was improvement in BASDAI at the end of therapy. Secondary outcome measures included improvement in BASDAI = 25%, BASFI, metrology parameters, visual analogue scales for pain and global assessment of disease, ESR, CRP, MMP-3 and quality of life domains. Results Out of 52 patients enrolled [47 men; mean age 36.2 years (range 22-53 years) and mean disease duration 7.2 years (3-25 years)], 47 patients completed the study. At 6 months, there were significant improvement in BASDAI ( P < 0.005), BASFI ( P < 0.005), pain ( P < 0.005) and patient global assessment of disease ( P < 0.005) and lateral flexion (P<0.05). However, BASDAI >25% reduction was seen in 29.6% patients only. In addition, quality of life, HAQ and serological markers MMP-3, ESR and CRP were not significantly altered. Most common adverse effects included arthralgias and myalgias, 22.5% each, following initial infusions. There were five withdrawals; two defaults and one for hip joint replacement and two for asymptomatic rise in serum creatinine. Conclusion Pamidronate has modest efficacy in improving the patient reported outcome variables in NSAID refractory AS.

Retrospective Study: The association of blood lactate concentration with outcome in dogs with idiopathic immune‐mediated hemolytic anemia: 173 cases (2003–2006)

AbstractObjective –To determine the association of blood lactate with outcome and response to transfusion therapy in dogs with idiopathic immune‐mediated hemolytic anemia (IMHA).Design –Retrospective study.Setting –Urban veterinary small animal emergency hospital.Animals –One hundred and seventy‐three client‐owned dogs with IMHA.Interventions –None.Measurements and Main Results –Serial blood lactate concentration, therapeutic interventions, and outcome were recorded. Nonsurvivors were defined as those that died or were euthanized. One hundred and thirty‐three dogs (77%) survived, 35 (20%) were euthanized, and 5 (3%) died. One hundred forty‐five dogs (84%; 145/173) had a lactate concentration above the laboratory reference interval [0.46–2.31 mmol/L] on presentation. Blood lactate at presentation was higher in the nonsurvivors (median 4.8 mmol/L; 0.5–13.6) compared with survivors (median 2.9 mmol/L; 0.3–13.2) (P&lt;0.01). All dogs presenting with hyperlactatemia that normalized (&lt;2.0 mmol/L) within 6 hours of admission survived, whereas, 71% of dogs that had a persistent hyperlactatemia at 6 hours survived (P=0.034). Lactate was positively correlated with age, BUN, and alkaline phosphatase, and inversely correlated with PCV. Receiver operating curve analysis for lactate concentration at admission as a test for outcome had an area under the curve of 0.69 with an optimal lactate cutoff concentration of 4.4 mmol/L correctly predicting outcome 73% of the time (sensitivity 60%, specificity 77%).Conclusions –Lactate concentration at presentation was significantly higher in nonsurvivors than survivors. Lactate was significantly correlated with previously reported outcome variables but lactate concentration at admission, as a predictor for outcome was less than optimal. However, serial lactate concentration measurements may be more predictive as patients with persistent hyperlactatemia 6 hours after admission were less likely to survive. Prospective studies evaluating serial lactate concentration while controlling for other variables may provide further insight into lactate measurement as a prognostic indicator in animals with IMHA.

Dynamics of Improvement Following Total Lumbar Disc Replacement

Prospective clinical study of total lumbar disc replacement (TDR) with ProDisc II (Synthes, Paoli, PA). To examine whether baseline variables VAS (Visual Analogue Scale) and ODI (Oswestry Disability Index) correspond with late and final postoperative outcome parameters and to identify early predictors of late outcome following total lumbar disc replacement (TDR). Previously published TDR studies reported on the pooled data averages collected from various cohort sizes. The individual patient's prognosis as well as prognostic factors of postoperative improvement remain unestablished. Data were accumulated prospectively and included VAS and ODI scores. The subjective outcome evaluation was based on a 3-scale grading system ("highly satisfied," "satisfied," "not satisfied"). An analysis was performed to ascertain whether the late and final outcome following TDR can be predicted based on preoperative and early postoperative data from the 3 and 6 month follow-up (FU). The overall results from 161 patients with an average FU of 4 years (mean: 45.5 months, range: 24.1-94.4 months) revealed a significant and maintained improvement of VAS and ODI scores (P < 0.0001). The most pronounced changes occurred within the early postoperative period (P < 0.0001) with no significant changes thereafter (P > 0.05).Baseline ODI levels were significantly correlated with VAS/ODI scores and patient satisfaction rates at the final FU (P < 0.0001).After surgery, early and late ODI levels were highly significantly correlated with each other (r = 0.84, P < 0.0001). Similar associations were observed between early and late VAS scores and patient satisfaction rates (P < 0.006).The individual patient's subjective outcome evaluation revealed stable postoperative results. An improvement or a deterioration by 2 classes on a 3-scale grading system was only observed in 3.1% (n = 5/161) of all cases overall. Patients with an early "highly satisfactory" result (n = 83) maintained either a satisfactory (15.7%, n = 13/83) or a highly satisfactory outcome (79.5%, n = 66/83) in 95.2% of all cases (n = 79/83).Conversely, the probability that patients with an "unsatisfactory" outcome would still achieve a "highly satisfactory" result after the early postoperative period was 5.0%. Baseline ODI and early postoperative outcome parameters (< or =6 months) revealed significant and strong associations with the final results following TDR. While the vast majority of patients with an early highly satisfactory outcome maintained satisfactory results at later FU stages, any significant improvement considered as "highly satisfied" is unlikely in a group of patients which reported early unsatisfactory results. In summary, any clinically relevant changes are unlikely to occur after the early postoperative period.The current findings offer a foundation for weighing both the patients and the spine surgeons expectations against possible realistic achievements. Although the data show that the midterm outcome at a FU of 4 years (mean: 45.5 months, range: 24.1-94.4 months) is predictable following TDR, the long-term results of lumbar disc replacements still need to be established.