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Objective: To determine whether paper tape prevents foot blisters in multistage ultramarathon runners. Design: Multisite prospective randomized trial. Setting: The 2014 250-km (155-mile) 6-stage RacingThePlanet ultramarathons in Jordan, Gobi, Madagascar, and Atacama Deserts. Participants: One hundred twenty-eight participants were enrolled: 19 (15%) from the Jordan, 35 (27%) from Gobi, 21 (16%) from Madagascar, and 53 (41%) from the Atacama Desert. The mean age was 39.3 years (22-63) and body mass index was 24.2 kg/m² (17.4-35.1), with 31 (22.5%) females. Interventions: Paper tape was applied to a randomly selected foot before the race, either to participants' blister-prone areas or randomly selected location if there was no blister history, with untaped areas of the same foot used as the control. Main Outcome Measures: Development of a blister anywhere on the study foot. Results: One hundred six (83%) participants developed 117 blisters, with treatment success in 98 (77%) runners. Paper tape reduced blisters by 40% (P< 0.01, 95% confidence interval, 28-52) with a number needed to treat of 1.31. Most of the study participants had 1 blister (78%), with most common locations on the toes (n = 58, 50%) and heel (n = 27, 23%), with 94 (80%) blisters occurring by the end of stage 2. Treatment success was associated with earlier stages [odds ratio (OR), 74.9, P < 0.01] and time spent running (OR, 0.66, P = 0.01). Conclusion: Paper tape was found to prevent both the incidence and frequency of foot blisters in runners. [ABSTRACT FROM AUTHOR]

Electronic diary assessment of pain and disability has become increasingly popular in adult chronic pain research but use of this methodology with children has received limited attention. The aim of this study was to compare two formats of a prospective daily diary (handheld computer=e-diary; paper diary=p-diary) on children''s compliance, accuracy, and acceptability ratings. Sixty children, ages 8–16 (M=12.3) with headaches or juvenile idiopathic arthritis, were randomized to receive either e-diaries administered via home visits (n=30) or p-diaries (n=30) handed out during clinic visits for return by mail. Results demonstrated significant mean differences in diary entries completed between groups, with children with e-diaries completing more days (M=6.6) compared to children with p-diaries (M=3.8), P<0.001. Diaries returned by children in the p-diary group contained significantly more errors and omissions compared to diaries returned by children in the e-diary group (which contained none), P<0.001. Children rated both diary formats as highly acceptable and easy to use. A significant gender×diary format interaction (P<0.01) was found for compliance where boys demonstrated greater compliance with the e-diary format. Findings demonstrated that the e-diary was feasible to use with children and showed significantly greater compliance and accuracy in diary recording compared to traditional paper diaries in a population of children with recurrent pain. [Copyright &y& Elsevier]

The article presents abstracts of papers on current clinical and basic investigation. They include "Randomized Double-Blind Prospective Trial of Active Management of the Third Stage of Labor", "Utility of Hybrid Capture 2 in Screening for Cervical Neoplasia", "17 Alpha-hydroxyprogesterone Caproate" and "Prevalence of Probable Overactive Bladder Among Black and Hispanic Women in a Group Practice."

A 0.09% pregnancy risk per cycle among combined oral contraceptive pill users reporting no missed pills likely approximates a true method-failure rate. OBJECTIVE: To assess the relationship of adherence and pregnancy in participants using an estetrol and drospirenone combined oral contraceptive. METHODS: We performed a secondary analysis for which we pooled data from two parallel, multicenter, phase 3 trials (United States and Canada, Europe and Russia) that enrolled participants 16–50 years of age to receive estetrol 15 mg and drospirenone 3 mg in a 24 hormone and four placebo pills regimen for up to 13 cycles. Participants reported pill intake, sexual intercourse, and other contraceptive use on paper diaries. We limited this efficacy analysis to at-risk cycles (one or more reported acts of intercourse and no other contraceptive use) in participants 16–35 years of age at screening. We excluded cycles with other contraceptive use unless pregnancy occurred in that cycle. We assessed primarily the relationship between number of pills not taken per cycle and pregnancies and, secondarily, when pregnancies occurred during product use with a test for trend and χ2 analyses as appropriate. RESULTS: Among 2,837 participants in this analysis, 31 on-treatment pregnancies occurred during 26,455 at-risk cycles. Pregnancies occurred in 0.09%, 0.25%, 0.83%, and 1.6% of cycles in which participants reported they took all hormone pills (n=25,613 cycles) or did not take one (n=405 cycles), two (n=121 cycles), and more than two (n=314 cycles) hormone-containing pills, respectively (P <.001). No pregnancies occurred in 2,216 cycles when one or more pills were missed and missed-pill instructions were followed. All pregnancies related to not taking pills occurred in the first three cycles. Pregnancy rates ranged from 0% to 0.21% per cycle with no significant trend by cycle (P =.45). CONCLUSION: Pregnancy occurs more frequently when combined oral contraceptive users report not taking all hormone-containing pills per 28-day cycle and exceeds 1% only when more than two pills are not taken. Pregnancies in participants who reported missed pills occurred only when missed-pill instructions were not followed. A 0.09% pregnancy risk per cycle among users of a 24 hormone and four placebo pills formulation who report taking all pills likely approximates a true method-failure rate. FUNDING SOURCE: Estetra SRL, an affiliate company of Mithra Pharmaceuticals. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02817828 and NCT02817841. [ABSTRACT FROM AUTHOR]

Background: Pain assessment and management are imperative parts of nursing care and considered as one of the most fundamental patient rights. The role of pain management education is well established in improving knowledge and attitude among nurses. Objectives: This study aims to evaluate the impact of pain management educational program on the knowledge and attitudes of intensive care unit (ICU) staff nurses toward pain assessment and management. The baseline score of pain assessment and management knowledge and attitude of ICU nurses has been identified in a previous research, and the result showed immense lack of knowledge and poor attitudes among ICU nurses toward pain assessment and management when dealing with ICU patients. Methods: This is a pretest-posttest experimental study, utilizing a self-reporting questionnaire tool to obtain information about nurses' knowledge and attitudes toward pain assessment and management after implementation of new pain management educational program for critical care nurses. Data were collected using the Knowledge and Attitudes Survey Regarding Pain tool that measures knowledge with 22 question items and measures attitude with 17 question items. Paper-based questionnaire was distributed to nurses for data collection. Results and Conclusion: The results showed significant improvement in knowledge and attitudes about pain assessment and management among ICU nurses; it was evident after delivering pain management education program. At baseline, 204 ICU nurses gave consent and completed the questionnaire and thus included in Background: Pain assessment and management are imperative parts of nursing care and considered as one of the most fundamental patient rights. The role of pain management education is well established in improving knowledge and attitude among nurses. Objectives: This study aims to evaluate the impact of pain management educational program on the knowledge and attitudes of intensive care unit (ICU) staff nurses toward pain assessment and management. The baseline score of pain assessment and management knowledge and attitude of ICU nurses has been identified in a previous research, and the result showed immense lack of knowledge and poor attitudes among ICU nurses toward pain assessment and management when dealing with ICU patients. Methods: This is a pretest-posttest experimental study, utilizing a self-reporting questionnaire tool to obtain information about nurses' knowledge and attitudes toward pain assessment and management after implementation of new pain management educational program for critical care nurses. Data were collected using the Knowledge and Attitudes Survey Regarding Pain tool that measures knowledge with 22 question items and measures attitude with 17 question items. Paper-based questionnaire was distributed to nurses for data collection. Results and Conclusion: The results showed significant improvement in knowledge and attitudes about pain assessment and management among ICU nurses; it was evident after delivering pain management education program. At baseline, 204 ICU nurses gave consent and completed the questionnaire and thus included in baseline measurement before implementing the intervention. In the postintervention measurement, the questionnaire was distributed to the same participants included in the baseline phase from which 181 participants completed the questionnaire for the second time, with a response rate of 89%; the deficits and preconception in pain assessment and management can be improved through implementing pain management educational programs. [ABSTRACT FROM AUTHOR]

We describe qualitative and quantitative development and preliminary validation of the Patient Assessment for Low Back Pain-Impacts (PAL-I), a patient-reported outcome measure for use in chronic low back pain (cLBP) clinical trials. Concept elicitation and cognitive interviews (qualitative methods) were used to identify and refine symptom concepts. Classical test theory and Rasch measurement theory (quantitative methods) were used to evaluate item-level and scale-level performance of the PAL-I using an iterative approach between qualitative and quantitative methods. Patients with cLBP participated in concept elicitation interviews (N = 43), cognitive interviews (N = 38), and assessment of paper-to-electronic format equivalence (N = 8). A web-based sample of self-reported patients with cLBP participated in quantitative studies to evaluate preliminary (N = 598) and revised (n = 401) drafts and patients with physician-diagnosed cLBP (N = 45) participated in preliminary validation of the PAL-I. The instrument contained 9 items describing cLBP impacts (walking, sitting, standing, lifting, sleep, social activities, travelling, climbing, and body movements). Item-level performance, scale structure, and scoring seemed to be appropriate. One-week test-retest reproducibility was acceptable (intraclass correlation coefficient 0.88 [95% confidence interval, 0.78-0.94]). Convergent validity was demonstrated with PAL-I total score and Roland-Morris Disability Questionnaire (Pearson correlation 0.82), MOS-36 Physical Functioning (-0.71), and MOS-36 Bodily Pain (-0.71). Individual item scores and total score discriminated between numeric rating scale tertile groups and painDETECT categories. Interpretation of paper and electronic administration modes was equivalent. The PAL-I demonstrated content validity and is potentially useful to assess treatment benefit in clinical trials of cLBP therapies. [ABSTRACT FROM AUTHOR]

This study sought to examine the effect of auricular acupressure therapy on the stress and sleep status of middle-aged women in South Korea. A quasi-experimental pretest/posttest control group design was employed. The study sample consisted of 67 middle-aged women (experimental: 35 samples; control: 32 samples) in Seoul, South Korea. Auricular acupressure therapy including the auricular acupressure needle on the skin paper tape was applied on an ear for 2 weeks, 2 times per week. The acupoints were Gyogam, Sinmun, Bushin, Naebunbi, and Pijilha. For the placebo control group, only the skin paper tape without the auricular acupressure needle was applied on the same acupoints. Measures were a stress scale, cortisol level in blood, and a sleep status scale. The findings showed that there were significant differences on stress (physical: t= 2.170, P< .033; psychological: t= 2.117, P< .037), cortisol level in blood ( t= 2.277, P< .025), and sleep status ( t= -3.127, P< .004). Health care providers should consider providing auricular acupressure therapy as an alternative method for reducing physical and psychological stress, cortisol level in blood, and sleep disturbance of middle-aged women in South Korea. [ABSTRACT FROM AUTHOR]

Background: Although tenotomy and tenodesis are frequently used for long head of the biceps tendon lesions, controversies remain as to which technique is superior regarding pain, functionality, complications, and cosmetic appearance.Questions/purposes: (1) For long head of biceps tendon lesions, does tenotomy or tenodesis result in greater improvements in VAS score for pain? (2) Which approach has superior results when evaluating function outcome (Constant) scores? (3) Does tenotomy or tenodesis have fewer complications? (4) Does tenotomy or tenodesis result in better cosmesis (Popeye sign)?Methods: A systematic review was performed in the Cochrane Library, Embase, PubMed, and Literatura Latino Americana e do Caribe em Ciências da Saúde (LILACS) using the keywords "long head of the biceps tendon," "biceps tenodesis," and "tenotomy." We completed the search in June 2020. The inclusion criteria were randomized controlled trials and quasirandomized controlled trials that investigated tenodesis and tenotomy with no language restriction and evaluation of adult patients who presented with a long head of the biceps tendon lesion, associated with other lesions or not, without previous shoulder surgeries and who had no response to nonoperative treatment. The initial search yielded 239 studies, 40 of which were duplicates. We assessed the titles and abstracts of 199 articles and excluded all studies that were not randomized controlled trials (literature reviews) or that compared different techniques. We assessed the full text of 14 articles and excluded the ones that were protocols and cohort studies. We evaluated the risk of bias using the Cochrane Collaboration tool. We included eight studies in this systematic review and meta-analysis, with a total of 615 participants, 306 of whom were treated with tenotomy and 309 with tenodesis. The median duration of follow-up was 2 years. Overall, the included studies had a low risk of bias. The complications evaluated were adhesive capsulitis, biceps brachii tear, cramps, and a subsequent second surgical procedure. We used a random model in this meta-analysis so that we could generalize the results beyond the included studies. In this study, we only reported differences between the groups if they were both statistically valid and larger than the minimum clinically important difference (MCID).Results: Comparing tenotomy and tenodesis, we observed no difference between the groups regarding pain in the long term (mean difference 0.25 [95% confidence interval -0.29 to 0.80]; p = 0.36). There was no difference in Constant score in the long-term (mean difference -1.45 [95% CI -2.96 to 0.06]; p = 0.06). There were no differences when evaluating for major complications (odds ratio 1.37 [95% CI 0.29 to 6.56]; p = 0.70). There were not enough papers evaluating adhesive capsulitis, cramping, and risk of revision surgery. Popeye sign was more frequent in the tenotomy group than in the tenodesis group (OR 4.70 [95% CI 2.71 to 8.17]; p < 0.001).Conclusion: This systematic review demonstrated that tenotomy and tenodesis offer satisfactory treatment for long head of the biceps tendon lesions. In terms of pain improvement and Constant score, there was no difference between the techniques, but patients undergoing tenotomy have worse cosmetic results. Therefore, surgeons should choose the technique based on their skills and the patient's expectations of surgery, such as cosmesis and time to recovery. More studies are needed to evaluate complications such as adhesive capsulitis and cramping, as well as to compare duration of surgery and recovery time for each technique.Level Of Evidence: Level I, therapeutic study. [ABSTRACT FROM AUTHOR]

The redefinition of neuropathic pain as "pain arising as a direct consequence of a lesion or disease affecting the somatosensory system," which was suggested by the International Association for the Study of Pain (IASP) Special Interest Group on Neuropathic Pain (NeuPSIG) in 2008, has been widely accepted. In contrast, the proposed grading system of possible, probable, and definite neuropathic pain from 2008 has been used to a lesser extent. Here, we report a citation analysis of the original NeuPSIG grading paper of 2008, followed by an analysis of its use by an expert panel and recommendations for an improved grading system. As of February, 2015, 608 eligible articles in Scopus cited the paper, 414 of which cited the neuropathic pain definition. Of 220 clinical studies citing the paper, 56 had used the grading system. The percentage using the grading system increased from 5% in 2009 to 30% in 2014. Obstacles to a wider use of the grading system were identified, including (1) questions about the relative significance of confirmatory tests, (2) the role of screening tools, and (3) uncertainties about what is considered a neuroanatomically plausible pain distribution. Here, we present a revised grading system with an adjusted order, better reflecting clinical practice, improvements in the specifications, and a word of caution that even the "definite" level of neuropathic pain does not always indicate causality. In addition, we add a table illustrating the area of pain and sensory abnormalities in common neuropathic pain conditions and propose areas for further research. [ABSTRACT FROM AUTHOR]

As a result of the coronavirus 2019 (Covid-19) pandemic, clinical research for substance use disorders (SUDs) has been impeded due to widespread stay-at-home mandates limiting the operations of "non-essential" work. Although appropriate to proceed with an abundance of caution to prevent viral spread, there will be detrimental consequences for patients with SUDs if clinical trials research cannot adapt and continue uninterrupted. The field of digital health has strong evidence for its feasibility and effectiveness and offers tools that can facilitate the continuation of SUD clinical trials research remotely in accordance with Covid-19 precautions. Some digital tools have been used as components of SUD research in the past; however, no published clinical trial in SUDs to-date has been entirely virtual. This has important implications for disrupted clinical care, as providers seek guidelines for best digital practices. This paper provides a roadmap for integrating the fields of digital health and SUD clinical trials by proposing methods to complete recruitment, screening, informed consent, other study procedures, and internal lab operations digitally. The immediate future of SUD research depends on the ability to comply with social distancing. Investment in research of digital clinical trials for SUDs provides an opportunity to cultivate benefits for research and clinical care long-term as we can (1) define regulatory requirements for the implementation of digital systems, (2) develop consensus on system-wide standards and protocols in the appropriate use of technology, and (3) gain experience that can translate to the treatment of patients with SUDs through telehealth in the community. [ABSTRACT FROM AUTHOR]

Study Design: Meta-analysis.Objective: To evaluate the efficacy and safety of total disc replacement (TDR) and anterior cervical discectomy and fusion for treating cervical degenerative diseases.Summary Of Background Data: Anterior cervical discectomy and fusion (ACDF) has been the traditional gold standard surgery for cervical degenerative diseases.Methods: Clinical databases including PubMed, MEDLINE, Cochrane and Clinical Trials.gov were searched. Review Manager 5.1 software and Stata 11.1 were used to analyze clinical data. Dichotomous pooled results were reported as relative risk (RR) and its 95% confidence interval (CI). Endpoints included clinical success rate, NDI success rate, neurological success rate, incidence of adverse event, reoperation rate and patient satisfaction.Results: Eight clinical trials and fifteen papers with 1440 TDR patients and 1237 ACDF patients were included in this meta-analysis. The TDR group had a higher clinical success rate (RR, 1.26; 95% CI, 1.13-1.41; P < 0.001; I = 79%), NDI success rate (RR, 1.16; 95% CI, 1.06-1.26; P = 0.001; I = 77%), neurological success rate (RR, 1.06; 95% CI, 1.03-1.10; P = 0.0004; I = 58%), and secondary surgery rate p (RR, 1.06; 95% CI, 1.03-1.09; P < 0.001; I = 0%) but lower secondary surgery rate (RR, 0.44; 95% CI, 0.31-0.63; P < 0.00001; I = 43%) compared with the ACDF group. There was no significant difference in the adverse event rate between the TDR group and Athe CDF group (RR, 0.44; 95% CI, 0.31-0.63; P < 0.001; I = 43%).Conclusion: From the meta-analysis, we conclude that the efficacy and safety of TDA are equivalent or superior to ACDF. TDR is associated with a higher overall success rate, NDI success rate, neurological success rate, reoperation rate and satisfaction rate compared with ACDF group. No differences exist in the risk of adverse event between the two groups.Level Of Evidence: 3. [ABSTRACT FROM AUTHOR]

While there is broad consensus about the need for interventions to help psychologically distressed, war ajfectedyouth, there is also limited research and even less agreement on which interventions work best. Therefore, this paper presents a randomised trial of trauma focused, and non trauma focused, interventions with war affected Congolese youth. Fifty war affected Congolese youth, who had been exposed to multiple adverse life events, were randomly assigned to either a Trauma Focused Cognitive Behavioural Therapy group or a non trauma based psychosocial intervention ( Child Friendly Spaces). Non clinically trained, Congolese facilitators ran both groups. A convenience sample, waiting list group was also formed. Using blind assessors, participants were individually interviewed at pre intervention, post intervention and a 6-month follow-up using self-report post-traumatic stress and internalising symptoms, conduct problems and pro social behaviour. Both treatment groups made statistically significant improvements, compared to the control group. Large, within subject, effect sizes were reported at both post intervention and follow-up. At the 6-month follow-up, only the Child Friendly Spaces group showed a significant decrease in pro social behaviour. The paper concludes that both trauma focused and non trauma focused interventions led to reductions in psychological distress in war affected youth. [ABSTRACT FROM AUTHOR]

Background: Displaced mid-third clavicle fractures are common, and their management remains unclear. Although several meta-analyses have compared specific operative techniques with nonoperative management, it is not possible to compare different operative constructs with one another using a standard meta-analysis. Conversely, a network meta-analysis allows comparisons among more than two treatment arms, using both direct and indirect comparisons between interventions across many trials. To our knowledge, no network meta-analysis has been performed to compare the multiple treatment options for displaced clavicle fractures.Questions/purposes: We performed a network meta-analysis of randomized, controlled trials (RCTs) to determine from among the approaches used to treat displaced midshaft clavicle fractures: (1) the intervention with the highest chance of union at 1 year, (2) the intervention with the lowest risk of revision surgery, and (3) the intervention with the highest functional outcome scores. Secondarily, we also (4) compared the surgical subtypes in the available RCTs on the same above endpoints.Methods: MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials were reviewed for relevant randomized controlled trials published up to July 25, 2018. Two hundred and eighty four papers were reviewed, with 22 meeting inclusion criteria of RCTs with appropriate randomization techniques, adult population, minimum of 1 year follow-up and including at least one operative treatment arm. In total, 1002 patients were treated with a plate construct, 378 with an intramedullary device, and 585 patients were managed nonoperatively. Treatment subtypes included locked intramedullary devices (56), unlocked intramedullary devices (322), anterior plating (89), anterosuperior plating (150), superior plating (449) or plating not otherwise specified (314). We performed a network meta-analysis to compare and rank the treatments for displaced clavicle fractures. We considered the following outcomes: union achievement, revision surgery risk and functional outcomes (DASH and Constant Scores). The minimal clinically important difference (MCID) was considered for both Constant and DASH scores to be at 8 points, representing the average of MCID scores reported for both DASH and Constant in the evidence, respectively.Results: Union achievement was lower in patients treated nonoperatively (88.9%), and higher in patients treated operatively (96.7%, relative risk [RR] 1.128 [95% CI 1.1 to 1.17]; p < 0.001), Number needed to treat (NNT) = 10). Union achievement increased with any plate construct (97.8%, RR 1.13 [95% CI 1.1 to 1.7]; p < 0.0001, NNT = 9) and with anterior or anterosuperior plates (99.3%, RR 1.14 [95% CI 1.1 to 1.8]; p < 0.0001, NNT = 8). Risk of reoperation, when considering planned removal of hardware, was similar across all treatment arms. Lastly, operative treatment outperformed nonoperative treatment with minor improvements in DASH and Constant scores, though not approaching the MCID. At the subtype level, anterosuperior plating ranked highest in DASH and Constant functional scores with mean differences reaching 10-point improvement for Constant scores (95% CI 4.4 to 2.5) and 7.6 point improvement for DASH (95% CI 5.2 to 20).Conclusions: We found that surgical treatment led to a greater likelihood of union at 1 year of follow-up among adult patients with displaced mid-third clavicle fractures. In aggregate, surgical treatment did not increase functional scores by amounts that patients were likely to consider clinically important. Use of specific subtypes of plating (anterior, anterosuperior) resulted in improvements in the Constant score that were slightly above the MCID but did not reach the MCID for the DASH score, suggesting that any outcomes-score benefits favoring surgery were likely to be imperceptible or small. In light of these findings, we believe patients can be informed that surgery for this injury can increase the likelihood of union incrementally (about 10 patients would need to undergo surgery to avoid one nonunion), but they should not expect better function than they would achieve without surgery; most patients can avoid surgery altogether with little absolute risk of nonunion. Patients who opt for surgery must be told that the decision should be weighed against complications and the possibility of undergoing a second procedure for hardware removal. Patients opting not to have surgery for acute midshaft clavicle fractures can be told that nonunion occurs in slightly more than 10% of patients, and that these can be more difficult to manage than acute fractures.Level Of Evidence: Level I, therapeutic study. [ABSTRACT FROM AUTHOR]

A main gap in the delivery of mental health and psychosocial (MHPSS) services to Rohingya refugees in Cox's Bazar district in Bangladesh is the limited coverage of psychotherapeutic interventions. There is a shortage of mental health professionals who can provide culturally adapted and linguistically appropriate psychotherapeutic interventions that are congruent with the refugee experience. This article describes preliminary work on training Bangladeshi psychologists and para-professionals in applying a novel group-based psychological intervention for refugees, Group Integrative Adapt Therapy (IAT-G). This is a pragmatic, eclectic and transdiagnostic approach, based on the Adaptation and Development After Persecution and Trauma (ADAPT) model. It aims to help refugees to develop resilience and capacities for managing maladaptive reactions to trauma and post-migration living difficulties. This paper describes the key strategies and challenges during the first phase of the project. Activities included an extensive desk review, a one-week training workshop with competency assessments, cultural adaptation of the treatment manual and assessment measures, training on digital literacy and electronic data collection and a blended supervisory model (involving onsite and online sessions). It proved to be generally feasible but not easy to introduce IAT-G in this population. [ABSTRACT FROM AUTHOR]

The current debate over the efficacy of lumbar fusion for low back pain has not been settled. Fritzell et al published a landmark paper entitled “Lumbar fusion versus nonsurgical treatment for chronic low back pain: a multicenter randomized controlled trial from the Swedish lumbar spine study group.” Their goal was to provide objective evidence supporting lumbar fusion. While it was well designed and important to our knowledge base, it has limitations. We set out to review their work in an unbiased yet critical manner. Our goals are to summarize the strengths and weaknesses of the paper, place it in the context of current knowledge, and highlight its significance for present-day practice and research. From technical and study design perspectives, Fritzell et al were able to validate the use of lumbar fusion for the treatment of low back pain. However, their use of “usual nonoperative” care and nonspecific definition of low back pain precluded a truly genuine comparison of operative and nonoperative groups. We commend the Swedish lumbar spine study group and their remarkable efforts; they elevated the sophistication of spine research and spawned many more excellent works to help settle the ongoing controversy on the ideal treatment of low back pain. [ABSTRACT FROM AUTHOR]

A systematic review and subset meta-analysis of published randomised controlled trials of psychological therapies for children and adolescents with chronic pain is reported. A search of four computerised abstracting services recovered 123 papers from which 28 potential trials were identified. Eighteen met the criteria for inclusion in the review. The majority of these papers reported brief behavioural and cognitive behavioural interventions for children with headache and many were conducted in community (i.e. school) settings. Meta-analysis was applicable for 12 headache trials and one trial of recurrent abdominal pain using the Pain Index. The odds-ratio for a 50% reduction in pain was 9.62 and the number needed to treat was 2.32, indicating that the psychological treatments examined are effective in reducing the pain of headache. The quality of the 18 trials retrieved is narratively reviewed and suggestions for the development of trials in this field are made. [Copyright &y& Elsevier]

Knowing when to use diagnostic testing and sur gery in the management of low back pain is often a dilemma for practitioners. This paper reviews the effectiveness of clinical practice guidelines in man aging 1,796 cases of low back pain or herniated lum bar disk reviewed by Health Risk Management, Inc. between November 1990 and October 1991. In all cases (except cauda equina syndrome or other rapidly progressing neurological deficit) a trial of conserva tive treatment, always including physical therapy, was requested prior to recommendation for diagnos tic testing or surgery. Ninety-one percent (1,628 cases) had completed an adequate trial of conserva tive therapy or had a lesion requiring immediate in tervention. These cases were recommended for the requested procedure or hospitalization. Of the 168 cases that were not recommended immediately for imaging, surgery, or hospitalization, 84.5% improved with conservative management and neither imaging nor surgery was necessary over a period of at least 12 months following the time of review. Efficacy of conservative management was independent of age, sex, part of the country in which the treatment took place, and primary diagnosis. Net savings realized after subtracting employer costs for the reviews were well over a third of a million dollars in this small group of patients. [ABSTRACT FROM PUBLISHER]

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Objective: To review the literature systematically to determine whether noninvasive or invasive risk stratification, such as with an electrophysiological study of patients with asymptomatic pre-excitation, reduces the risk of arrhythmic events and improves patient outcomes.Methods: PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials (all January 1, 1970, through August 31, 2014) were searched for randomized controlled trials and cohort studies examining noninvasive or invasive risk stratification in patients with asymptomatic pre-excitation. Studies were rejected for low-quality design or the lack of an outcome, population, intervention, or comparator of interest or if they were written in a language other than English.Results: Of 778 citations found, 9 studies met all the eligibility criteria and were included in this paper. Of the 9 studies, 1 had a dual design-a randomized controlled trial of ablation versus no ablation in 76 patients and an uncontrolled prospective cohort of 148 additional patients-and 8 were uncontrolled prospective cohort studies (n=1594). In studies reporting a mean age, the range was 32 to 50 years, and in studies reporting a median age, the range was 19 to 36 years. The majority of patients were male (range, 50% to 74%), and <10% had structural heart disease. In the randomized controlled trial component of the dual-design study, the 5-year Kaplan-Meier estimates of the incidence of arrhythmic events were 7% among patients who underwent ablation and 77% among patients who did not undergo ablation (relative risk reduction: 0.08; 95% confidence interval: 0.02 to 0.33; P<0.001). In the observational cohorts of asymptomatic patients who did not undergo catheter ablation (n=883, with follow-up ranging from 8 to 96 months), regular supraventricular tachycardia or benign atrial fibrillation (shortest RR interval >250 ms) developed in 0% to 16%, malignant atrial fibrillation (shortest RR interval ≤250 ms) in 0% to 9%, and ventricular fibrillation in 0% to 2%, most of whom were children in the last case.Conclusions: The existing evidence suggests risk stratification with an electrophysiological study of patients with asymptomatic pre-excitation may be beneficial, along with consideration of accessory-pathway ablation in those deemed to be at high risk of future arrhythmias. Given the limitations of the existing data, well-designed and well-conducted studies are needed. [ABSTRACT FROM AUTHOR]

Keiner, M, Kadlubowski, B, Sander, A, Hartmann, H, and Wirth, K. Effects of 10 months of speed, functional, and traditional strength training on strength, linear sprint, change of direction, and jump performance in trained adolescent soccer players. J Strength Cond Res 36(8): 2236–2246, 2022—The current study aimed to compare the effects of plyometric and sprint vs. functional vs. strength training on linear sprint (LS 20 m), change of direction (COD; i.e., turning right and left), jump (squat jump [SJ]), and maximum strength (1 repetition maximum [1RM] for a squat) performance in elite adolescent soccer players. A longitudinal design was chosen, and 48 elite male youth were recruited. The athletes were divided into 4 groups (a traditional strength training group [STG], a plyometric and sprint training group [PSTG], a functional training group [FTG], and a control group [CG]). The intervention groups trained for 10 months with additional sessions added to their regular soccer training (4–5 sessions per week); the additional training (2 sessions a week [each about 60 minutes]) consisted of plyometric and sprint training, functional training, and traditional strength training for the PSTG, FTG, and STG, respectively. Data were analyzed using analysis of variance with repeated measurements. The effect sizes were calculated using Hedges g. This study showed significantly superior performance increases with traditional strength training compared with sprint and jump training and functional training for maximum strength (compared with all other groups g = 0.98–1.61), SJ (g = 0.52–0.87 compared with FGT and CG; not significantly different from PSTG), COD (direction of rotation right: compared with all other groups g = 1.58–2.12; direction of rotation left: no significant differences), and 20-m LS (compared with all other groups g = 0.86–1.39) performance over time. Traditional strength training is recommended to increase strength and speed-strength variables and should therefore be given high priority in athletic training programs for elite youth soccer players. [ABSTRACT FROM AUTHOR]

There are an increasing number of published single-method systematic reviews that focus on different types of evidence related to a particular topic. As policy makers and practitioners seek clear directions for decision-making from systematic reviews, it is likely that it will be increasingly difficult for them to identify 'what to do' if they are required to find and understand a plethora of syntheses related to a particular topic. Mixed-methods systematic reviews are designed to address this issue and have the potential to produce systematic reviews of direct relevance to policy makers and practitioners. On the basis of the recommendations of the Joanna Briggs Institute International Mixed Methods Reviews Methodology Group in 2012, the Institute adopted a segregated approach to mixed-methods synthesis as described by Sandelowski et al., which consists of separate syntheses of each component method of the review. Joanna Briggs Institute's mixed-methods synthesis of the findings of the separate syntheses uses a Bayesian approach to translate the findings of the initial quantitative synthesis into qualitative themes and pooling these with the findings of the initial qualitative synthesis. [ABSTRACT FROM AUTHOR]

Eliminating publication bias requires ensuring public awareness of studies and access to results. Clinical trial registries provide basic trial information, but access to unbiased trial results is inadequate. Nearly all studies of trial registration and results reporting have been limited to the ClinicalTrials.gov registry. We analyzed trial registration, registry functionality, cross-registry harmonization, and results reporting on all 15 primary registries in the World Health Organization International Clinical Trials Registry Platform (ICTRP) for postherpetic neuralgia, painful diabetic neuropathy, and fibromyalgia. A total of 447 unique trials were identified, with 86 trials listed on more than one registry. A comprehensive search algorithm was used to find trial results in the peer-reviewed literature and the grey literature. Creating a global database of registered trials and trial results proved surprisingly difficult for several reasons: (1) ICTRP does not reliably identify trials listed on multiple registries, manual searches are necessary; (2) Searching ICTRP yields different results than searching individual registries; (3) Outcome measure descriptions for multiply registered trials vary between registries; (4) Registry-publication pairings are often inaccurate or incomplete; (5) Grey literature results are not permanent. Overall, only 46% of all trials had results available. Trials registered on ClinicalTrials.gov were significantly more likely to have results (52% vs. 18%, P<0.001), partly due to the ability to post results directly to the registry. In addition to the simple remedy of including trial registration numbers on all meeting abstracts and peer-reviewed papers, specific strategies are offered to facilitate identifying multiply registered studies and ensuring accurate pairing of results and publications. [ABSTRACT FROM AUTHOR]

Background The use of botulinum toxin A (Bo NT- A) for aesthetic treatments is growing steadily, and new safety data have been reported in recently published studies. Objective To investigate the safety data on the use of the three Bo NT- A formulations approved for facial aesthetics from recent studies and to confirm their safety profiles. Methods The literature search was conducted using three online databases restricted to the timeframe from January 2000 to June 2012. Only clinical trials, randomized or open label, with safety as the primary or secondary endpoint, were included. Results Thirty-five papers were selected, with a total of subjects 8,787 studied. OnabotulinumtoxinA was used in 60.0% of the studies, abobotulinumtoxinA in 37.1%, and incobotulinumtoxinA in 2.8%. The glabella was the most investigated area (51.4%), followed by the upper face (25.7%), crow's feet (11.4%), and lower face (11.4%). Treatment-related adverse events were blepharoptosis (2.5%), brow ptosis (3.1%), and eye sensory disorders (3%) in the upper face and lip asymmetries and imbalances in the lower face (6.9%). All of these events resolved spontaneously. Conclusion The short-term safety profile of Bo NT- A in cosmetic nonsurgical procedures was confirmed for all the three commercial formulations. [ABSTRACT FROM AUTHOR]

Randomized controlled trials (RCTs) represent the gold standard of evidence-based medicine. However, over the last several decades, the cost associated with conducting RCTs has increased dramatically. Several factors contribute to higher costs associated with clinical trials. This paper describes important barriers to conducting surgical RCTs, identifies funding sources available to finance RCTs, and suggests strategies to maintain cost-efficient study practices as we move into the next decade. [ABSTRACT FROM AUTHOR]

The superiority of the evidence generated in randomized controlled trials over observational data is not only conditional to randomization. Randomized controlled trials require proper design and implementation to provide a reliable effect estimate. Adequate random sequence generation, allocation implementation, analyses based on the intention-to-treat principle, and sufficient power are crucial to the quality of a randomized controlled trial. Power, or the probability of the trial to detect a difference when a real difference between treatments exists, strongly depends on sample size. The quality of orthopaedic randomized controlled trials is frequently threatened by a limited sample size. This paper reviews basic concepts and pitfalls in sample-size estimation and focuses on the importance of large trials in the generation of valid evidence. [ABSTRACT FROM AUTHOR]

Background and Purpose--The guidelines presented in this consensus statement are intended to serve researchers, clinicians, reviewers, and regulators in the selection of the most appropriate primary outcome for a clinical trial of cardiac arrest therapies. The American Heart Association guidelines for the treatment of cardiac arrest depend on high-quality clinical trials, which depend on the selection of a meaningful primary outcome. Because this selection process has been the subject of much controversy, a consensus conference was convened with national and international experts, the National Institutes of Health, and the US Food and Drug Administration. Methods--The Research Working Group of the American Heart Association Emergency Cardiovascular Care Committee nominated subject leaders, conference attendees, and writing group members on the basis of their expertise in clinical trials and a diverse perspective of cardiovascular and neurological outcomes (see the online-only Data Supplement). Approval was obtained from the Emergency Cardiovascular Care Committee and the American Heart Association Manuscript Oversight Committee. Preconference position papers were circulated for review; the conference was held; and postconference consensus documents were circulated for review and comments were invited from experts, conference attendees, and writing group members. Discussions focused on (1) when after cardiac arrest the measurement time point should occur; (2) what cardiovascular, neurological, and other physiology should be assessed; and (3) the costs associated with various end points. The final document underwent extensive revision and peer review by the Emergency Cardiovascular Care Committee, the American Heart Association Science Advisory and Coordinating Committee, and oversight committees. Results--There was consensus that no single primary outcome is appropriate for all studies of cardiac arrest. The best outcome measure is the pairing of a time point and physiological condition that will best answer the question under study. Conference participants were asked to assign an outcome to each of 4 hypothetical cases: however, there was not complete agreement on an ideal outcome measure even after extensive discussion and debate. There was general consensus that it is appropriate for earlier studies to enroll fewer patients and to use earlier time points such as return of spontaneous circulation, simple "alive versus dead," hospital mortality, or a hemodynamic parameter. For larger studies, a longer time point after arrest should be considered because neurological assessments fluctuate for at least 90 days after arrest. For large trials designed to have a major impact on public health policy, longer-term end points such as 90 days coupled with neurocognitive and quality-of-life assessments should be considered, as should the additional costs of this approach. For studies that will require regulatory oversight, early discussions with regulatory agencies are strongly advised. For neurological assessment of post-cardiac arrest patients, researchers may wish to use the Cerebral Performance Categories or modified Rankin Scale for global outcomes. Conclusions--Although there is no single recommended outcome measure for trials of cardiac arrest care, the simple Cerebral Performance Categories or modified Rankin Scale after 90 days provides a reasonable outcome parameter for many trials. The lack of an easy-to-administer neurological functional outcome measure that is well validated in post-cardiac arrest patients is a major limitation to the field and should be a high priority for future development. [ABSTRACT FROM AUTHOR]

Ill-defined causal questions present serious problems for observational studies-problems that are largely unappreciated. This paper extends the usual counterfactual framework to consider causal questions about compound treatments for which there are many possible implementations (for example, "prevention of obesity"). We describe the causal effect of compound treatments and their identifiability conditions, with a special emphasis on the consistency condition. We then discuss the challenges of using the estimated effect of a compound treatment in one study population to inform decisions in the same population and in other populations. These challenges arise because the causal effect of compound treatments depends on the distribution of the versions of treatment in the population. Such causal effects can be unpredictable when the versions of treatment are unknown. We discuss how such issues of "transportability" are related to the consistency condition in causal inference. With more carefully framed questions, the results of epidemiologic studies can be of greater value to decision-makers. [ABSTRACT FROM AUTHOR]

BACKGROUND This paper presents interim results of a 5-year Food and Drug Administration postapproval study to evaluate the long-term safety and patient satisfaction of an advanced polymethylmethacrylate (PMMA)-based filler for the correction of nasolabial folds (NLFs). OBJECTIVE To report the incidence of adverse events, including granuloma formation, and subject satisfaction. MATERIALS AND METHODS Safety data were evaluated for 1,008 subjects treated. Treatment was administered at day 1 plus one or two additional touch-ups, as required, through day 60. Potential adverse events, subject satisfaction, and any additional cosmetic treatments received in the treatment area were evaluated over an 18-month follow-up period. RESULTS Approximately 6% (63/1,008) of patients reported 82 device-related adverse events. Overall, 19% (187/1,008) of subjects experienced adverse events, the majority of which were mild; none were unanticipated. There were 14 serious adverse events reported; none of which were device related. One granuloma was reported, which resolved completely with a single medical treatment. Subject satisfaction with treatment remained high (∼80% very satisfied or satisfied) throughout the follow-up period. CONCLUSION Results confirm and further support the long-term safety and efficacy of this PMMA filler for the correction of NLFs. Suneva Medical, Inc. sponsored this Food and Drug Administration clinical trial and provided editorial support. [ABSTRACT FROM AUTHOR]

Information about several papers discussed at the inaugural International Symposium in Placebo, which was held in Sao Paulo, Brazil in February 2009, on placebo-controlled trials in the field of physical and rehabilitation medicine (PRM) is presented. Topics include the condition of randomized clinical trials in PRM, issues regarding the use of placebo in the field, and the utilization of placebo in acupuncture trials. The event also discussed several recommendations for placebo controls in PRM.

This article focuses on items to consider when selecting outcome measures for a clinical study. The choice of outcome measures depends largely on the research question and the study design. Sample-size requirements can vary greatly, depending on the type and the number of outcome measures selected. In this paper, we review the differences between categorical and continuous outcomes as well as the differences between primary and secondary outcomes and we discuss the concept of minimally important differences and the problems associated with composite outcomes. We also provide instruction on how to conduct and present a sample-size calculation. [ABSTRACT FROM AUTHOR]

The article compares the effectiveness of tension-free vaginal tape with the effectiveness of transobturator tape (TVT) in 164 women with stress urinary incontinence and intrinsic sphincter deficiency. The researchers found that retropubic TVT is more effective than TVT sling in women with urodynamic stress incontinence.

Background: The optimal treatment for cartilage lesions has not yet been established. The objective of this randomized trial was to compare autologous chondrocyte implantation with microfracture. This paper represents an update, with presentation of the clinical results at five years. Methods: Eighty patients who had a single chronic symptomatic cartilage defect on the femoral condyle in a stable knee without general osteoarthritis were included in the study. Forty patients were treated with autologous chondrocyte implantation, and forty were treated with microfracture. We used the International Cartilage Repair Society, Lysholm, Short Form-36, and Tegner forms to collect clinical data, and radiographs were evaluated with use of the Kellgren and Lawrence grading system. Results: At two and five years, both groups had significant clinical improvement compared with the preoperative status. At the five-year follow-up interval, there were nine failures (23%) in both groups compared with two failures of the autologous chondrocyte implantation and one failure of the microfracture treatment at two years. Younger patients did better in both groups. We did not find a correlation between histological quality and clinical outcome. However, none of the patients with the best-quality cartilage (predominantly hyaline) at the two-year mark had a later failure. One-third of the patients in both groups had radiographic evidence of early osteoarthritis at five years. Conclusions: Both methods provided satisfactory results in 77% of the patients at five years. There was no significant difference in the clinical and radiographic results between the two treatment groups and no correlation between the histological findings and the clinical outcome. One-third of the patients had early radiographic signs of osteoarthritis five years after the surgery. Further long-term follow-up is needed to determine if one method is better than the other and to study the progression of osteoarthritis. Level of Evidence: Therapeutic Level I. See Instructions to Authors for a complete description of levels of evidence. [ABSTRACT FROM AUTHOR]

The article discusses the bilateral asymmetries in clinical measures of lower-extremity anatomic characteristics. The paper aims to quantify side-to-side differences in lower-extremity anatomic characteristics, and to compare the magnitude of left-right differences with the measurement error for each variable. It measures the total leg length, pelvic ankle, hip anteversion, standing and supine quadriceps angle, tibiofemoral angle, knee laxity, genu recurvatum, femur and tibia length, tibial torsion, rearfoot angle and navicular drop.

Information about several papers discussed at the 119th Annual Meeting of the American Orthopedic Association in San Antonio, Texas is presented. It highlights randomized clinical trials as the most scientifically valid design for clinical research and widely recognized by orthopedic surgeons. Disciplines depicting on randomized clinical trials were also discussed.

Published clinical trials support the use of 0.2 to 0.4 percent nitroglycerin ointment for the treatment of an anal fissure, although no product is yet available in the United States. In 2004, 84,000 prescriptions were written for compounded nitroglycerin ointment. This study was designed to evaluate the quality of extemporaneously compounded nitroglycerin ointment. Prescriptions for 0.3 percent nitroglycerin ointment were filled at retail pharmacies and shipped to analytical laboratory for analysis by their validated method. Five of 24 (20.8 percent) samples did not meet the United States Pharmacopoeia requirement for content uniformity of 90 to 110 percent and< 6 percent relative standard deviation. Seven of 24 samples (29.2 percent) were subpotent based on the United States Pharmacopoeia requirement of 90 to 115 percent of label claim, and 1 sample was suprapotent. When considered for potency and/or content uniformity, 11 of 24 (45.8 percent) were misbranded and poor quality. Forty-six percent of the nitroglycerin ointment products compounded by 24 pharmacies did not meet the United States Pharmacopoeia specifications for potency and/or content uniformity when filling a prescription for 0.3 percent nitroglycerin ointment. These results raise significant issues regarding whether patients are put at undue risk relative to the relief of anal fissure pain. The pain associated with chronic anal fissure is severe, often debilitating, and may affect the patient’s ability to work. [ABSTRACT FROM AUTHOR]

Intra-articular viscosupplementation with hyaluronic acid has become an increasingly accepted therapeutic alternative in the symptomatic management of osteoarthritis. Basic science research has documented numerous potential actions of exogenous hyaluronic acid upon the diseased joint. A substantial aggregate of clinical data suggests that viscosupplementation is clinically safe and suggests some therapeutic efficacy with regard to pain relief. However, a robust placebo effect and industry bias have obscured these outcomes considerably. Although recent attention has focused on the disease-modifying potential of this treatment option, definitive evidence is lacking. This paper will review the development, experience, indications, and clinical outcomes of viscosupplementation therapy in patients with osteoarthritis. [ABSTRACT FROM AUTHOR]

The article focuses on the meta-analytic review of interventions to reduce HIV-infected individuals' sexual risk in a research synthesis of randomized controlled trials from 1993-2004. Significantly, reports were gathered from computer databases, relevant journals and conference proceedings, and reference sections of obtained papers. The results of the study have indicated that intervention participants exhibited lowered sexual risk relative to control participants on condom use but not for number of sexual partners. Finally, behavioral interventions reduced sexual risk if they included motivational and skills components.

Vitamin D shows significant potential as a therapy for prostate cancer. However, its use in clinical trials has been hampered by its induction of hypercalcemia at serum concentrations required to suppress cancer cell proliferation. This has spurred the development of less calcemic analogs of vitamin D. In this article, we review the clinical trials and consider the future directions of the use of vitamin D and its analogs in the treatment or chemoprevention of prostate cancer. First, we summarize the epidemiological evidence leading to the hypothesis that vitamin D has anticancer activity. We then review the clinical trials using vitamin D analogs that involve patients with prostate cancer and conclude with a brief overview of our planned study with vitamin D5, [1αOH)D5], which will begin shortly. Data for this review were identified by searches of PubMed, the Cochrane Library, Biosis, and references from relevant articles, using the search terms ‘vitamin D,’ ‘prostate cancer,’ ‘chemoprevention’ and ‘vitamin D analog.’ Abstracts from recent international meetings were also reviewed but were only included when they were the only known reference to the clinical trial or the research mentioned. Only papers published in English were included. [ABSTRACT FROM AUTHOR]

STUDY DESIGN.: Systematic review. OBJECTIVES.: To assess efficacy and safety of spinal cord stimulation in patients with chronic leg and back pain and failed back surgery syndrome and to examine prognostic factors that predict spinal cord stimulation outcome. SUMMARY OF BACKGROUND DATA.: A previous systematic review of spinal cord stimulation in patients with chronic back and leg pain and failed back surgery syndrome by Turner et al in 1995 identified 39 case studies and no controlled studies. METHODS.: A number of electronic databases were searched through January 2002. Citation searching of included papers was undertaken, and gray literature was sought through contact with clinical experts. No language restrictions were applied. All controlled and noncontrolled study designs were included. Study selection was carried out independently by two reviewers. Prognostic factors (age, sex, duration of pain, time post surgery, follow-up duration, publication year, data collection year, indication, data collection country, study setting, and quality score) responsible for pain relief outcome across case series were examined using univariate and multivariate metaregression. RESULTS.: One randomized controlled trial, one cohort study, and 72 case studies were included. The randomized controlled trial reported a significant benefit (P = 0.047) in the proportion of patients with failed back surgery syndrome reporting 50% or more pain relief with spinal cord stimulation (37.5%) compared with patients undergoing back reoperation (11.5%). There was evidence of substantial statistical heterogeneity (P < 0.0001) in the level of pain relief following spinal cord stimulation reported across case series studies. The four principal prognostic factors found to be predictive of increased level of pain relief with spinal cord stimulation were poor study quality score, short follow-up duration, multicenter (versus single center) studies, and the inclusion of patients with failed back surgery syndrome (versus chronic back and leg pain). Overall, 43% of patients with chronic back and leg pain/failed back surgery syndrome experienced one or more complications following a spinal cord stimulation implant, although no major adverse events were reported. CONCLUSIONS.: Despite an increase in the number of studies over the last 10 years, the level of evidence for the efficacy of spinal cord stimulation in chronic back and leg pain/failed back surgery syndrome remains moderate. Prognostic factors found to be predictive of the level of pain relief following spinal cord stimulation were study quality, follow-up duration, study setting, and patient indication. [ABSTRACT FROM AUTHOR]

Whyte J, Hart T, Vaccaro M, Grieb-Neff P, Risser A, Polansky M, Coslett HB: Effects of methylphenidate on attention deficits after traumatic brain injury: A multidimensional, randomized, controlled trial. Am J Phys Med Rehabil 2004;83:401'''420. OBJECTIVE:: To evaluate the effects of methylphenidate on a variety of aspects of attention, ranging from laboratory-based impairment measures to caregiver ratings and work productivity, in individuals after traumatic brain injury. DESIGN:: A total of 34 adults with moderate to severe traumatic brain injury and attention complaints in the postacute phase of recovery were enrolled in a 6-wk, double-blind, placebo-controlled, repeated crossover study of methylphenidate, administered in a dose of 0.3 mg/kg/dose, twice a day. A wide range of attentional measures was gathered weekly, including computerized and paper-and-pencil tests of attention, videotaped records of individual work in a distracting environment, real-time observational scoring of attentiveness in a classroom environment, and caregiver and clinician rating scales of attentiveness. Participants also attempted to guess their drug condition each week. Data from the first ten participants were used for pilot purposes, to develop attentional factors for composite scoring, and to identify attentional dimensions suggestive of a treatment effect for independent replication. The remaining 24 participants'' results were used to confirm potential treatment effects seen in the pilot sample, using Wilcoxon''s signed-ranks test on composite factor scores and individual variables. RESULTS:: A total of 54 dependent variables were reduced to 13 composite factors and 13 remaining individual variables. Of the 13 attentional factors, five showed suggestive treatment effects in the pilot sample. Of these, three showed statistically significant treatment effects in the replication sample: speed of information processing (effect sizes, &minus;0.06 to 0.48; P < 0.001), attentiveness during individual work tasks (effect sizes, 0.15'''0.62; P = 0.01), and caregiver ratings of attention (effect sizes, 0.44'''0.50; P = 0.01). Of the individual variables, four showed suggestive treatment effects in the pilot sample, but only one showed significant treatment effects in the replication sample: reaction time before errors in the Sustained Attention to Response Task (effect size, 0.20; P = 0.03). No treatment-related improvement was seen in divided attention, sustained attention, or susceptibility to distraction. None of the variables showed suggestive or definite negative treatment effects. Effect sizes for those performance measures positively affected by methylphenidate were in the small to medium range and included both impairment and activity level measures. Improvements in processing speed did not seem to come at the expense of accuracy. CONCLUSIONS:: Methylphenidate, at 0.3 mg/kg/dose, given twice a day to individuals with attentional complaints after traumatic brain injury, seems to have clinically significant positive effects on speed of processing, caregiver ratings of attention, and some aspects of on-task behavior in naturalistic tasks. Further research is needed to identify the optimal dose and to extend these findings to less carefully selected individuals. [ABSTRACT FROM AUTHOR]

This paper reports an experimental investigation of attentional engagement to and disengagement from pain. Thirty-seven pain-free volunteers performed a cueing task in which they were instructed to respond to visual target stimuli, i.e. the words ‘pain’ and ‘tone’. Targets were preceded by pain stimuli or tone stimuli as cues. Participants were characterized as high or low pain catastrophizers, using self-reports. We found that the effect of cueing upon target detection was differential for high and low pain catastrophizers. Analyses revealed a similar amount of attentional engagement to pain in both groups. However, we also found that participants high in pain catastrophizing had difficulty disengaging from pain, whereas participants low in pain catastrophizing showed no retarded disengagement from pain. Our results provide further evidence that catastrophic thinking enhances the attentional demand of pain, particularly resulting in difficulty disengaging from pain. The clinical implications of these findings are discussed. [Copyright &y& Elsevier]

Recent data suggest that single-joint exercises are unnecessary to maximize the resistance training (RT) results in novice to advanced individuals. However, the present literature is still inconsistent on this topic and controversy arises. The aim of this study was to compare the effects of the unilateral dumbbell row (DR) (multiple-joint) vs. unilateral biceps curl (BC) (single-joint) exercises on strength and elbow flexors muscle thickness (MT). Ten untrained men were assigned to an 8-week RT program for elbow flexors, one arm performing DR and the other performing BC in a within-subject design. After a familiarization, pretraining MT was measured using an ultrasound (US) technique, and strength was tested using 10 repetition maximum (10RM) tests. After pretesting, 8 weeks of RT (4–6 sets, 8–12 repetitions to concentric failure, 2 sessions per week) was performed. Post-testing was conducted in the same order as pretesting 48 and 72 hours after the last session. Single-joint BC exercise resulted in higher hypertrophy of elbow flexors (11.06%) than the DR (5.16%) multijoint exercise after 8 weeks of RT (p50.009). The 10RM improvement was higher for DR in DR-trained arm, whereas 10RM for BC was higher in BC-trained arm. The single-joint exercise resulted in higher hypertrophy of the elbow flexors than multijoint exercise after 8 weeks of RT, whereas strength improvements were greater in accordance with specificity of RT exercise. Therefore, in RT prescription for elbow flexors hypertrophy, single-joint exercises such as BC should be emphasized. [ABSTRACT FROM AUTHOR]

OBJECTIVENeutrophils are an important component of the inflammatory response that characterizes acute lung injury (ALI). This discussion aims to review the contribution of neutrophils to the development and progression of ALI and to highlight the major intracellular signaling pathways that are involved in neutrophil activation in the setting of ALI.DATA SOURCESMEDLINE, original research papers, and review papers.STUDY SELECTIONRelevant laboratory and clinical studies.DATA EXTRACTIONSystemic review.DATA SYNTHESISActivated neutrophils appear to play a central role in the development of most cases of ALI. In experimental models, the elimination of neutrophils markedly decreases the severity of ALI. Furthermore, in neutropenic patients with lung injury, deterioration of pulmonary function as neutropenia resolves has been well described. The neutrophils that accumulate in the lungs in models of ALI demonstrate increased activation of the kinases Akt and p38; increased nuclear accumulation of the transcriptional regulatory factor, nuclear factor-κB; and increased production of proinflammatory cytokines, particularly those whose transcription is dependent on nuclear factor-κB. Decreased apoptosis among neutrophils in the lungs is also characteristic. Inhibiting p38, Akt, or nuclear factor-κB activation diminishes the severity of endotoxin- or hemorrhage-induced ALI.CONCLUSIONSThe accumulation of activated neutrophils in the lungs is an early step in the pulmonary inflammatory process that leads to ALI. Although experimental models indicate that the activation of p38, Akt, and nuclear factor-κB in neutrophils contributes to ALI, the relative importance of these pathways in critically ill patients remains to be determined. Nevertheless, modulation of the activation of p38, Akt, and nuclear factor-κB in neutrophils appears to be an appropriate therapeutic target in severely ill patients with ALI. [ABSTRACT FROM AUTHOR]

The Memory and Medical Care Study (MMCS) is a community-based, longitudinal study of elders at risk for dementia. This paper describes the study methods for identifying subjects with dementia or mild cognitive impairment (MCI) and the validation of these methods. The MMCS cohort was established by identifying subjects at risk for dementia in three previous studies of randomly ascertained samples. Neuropsychologic test score criteria were established to identify MMCS subjects with dementia or MCI. These criteria were validated using a fourth community-based sample of at-risk elders in which dementia was identified by a clinical adjudication panel. Of the 498 MMCS subjects, 70% had dementia and 27% had MCI by the MMCS criteria. In the validation sample, the MMCS dementia classification method was in agreement with the clinical adjudication panel for 81% of cases (kappa = 0.62, 95% confidence interval = 0.45-0.78). The methods used in the MMCS are efficient and reasonably valid for establishing a cohort of subjects to investigate how dementia is assessed, diagnosed, and treated in the community. [ABSTRACT FROM AUTHOR]

PURPOSE: While dysfunctional daily symptoms due to stress, anxiety, headache, fatigue and/or poor sleep pattern, the associated quality of life issues are particularly distressing. In addition, commonly employed drug therapies have not always provided satisfactory relief. Medium chain triglyceride (MCT) oil has demonstrated clinical benefits in multiple domains, notably brain function. This pilot study investigated if an MCT-containing blend could influence a spectrum of disturbing symptoms not often measured, such as light or sound sensitivity with an on-line survey tool for a 30-day period. METHODS: In an open-label trial of this patented complex, fourteen (n=14) chronic symptom sufferers, mostly related to headache, were prospectively selected to participate in the study. Instructions to participants included maintaining a consistent lifestyle, health factors, and medications while consuming the study compound. With awareness of the current Corona virus pandemic, the original paper version of the quality-of-life survey developed was converted to an electronic response form to allow subjects increased safety in assessing their clinical status. RESULTS: As measured by the online-survey tool, a combined measure of ten specific symptoms (including light and sound sensitivity, vertigo, etc.) decreased according to subject rating, by an average of 32%. In global symptom rating, the subjects reduced the number of disrupting episodes by 39% from the baseline period compared to after 30 days of using the supplement. The average duration of the inciting cause decreased from 388 minutes to 152 minutes, a 61% reduction. Days/events missed due to symptom severity or complications were reduced from five per month to two per month, a decrease of 60%. CONCLUSION: In this initial study, life quality symptom surveys can be converted to electronic record keeping, a benefit for both the patient and the clinician. Consumption of a high concentration MCT complex produced significant improvements in the spectrum of symptoms across a broad domain of the measured variables. [ABSTRACT FROM AUTHOR]

Resisted sprinting (RS) is a popular training method used to enhance sprinting performance in youth. However, research has only explored the effects of forward RS (FRS) training. We examined the effects of FRS and backward RS (BRS) and compared these with a traditional physical education curriculum (CON). One hundred fifteen boys (age 13-15 years) were matched for maturity and allocated to either an FRS (n = 34), BRS (n = 46), or CON (n = 35) group. Training groups towed progressively overloaded sleds (20-55% body mass) 2 d⋅wk-1 for 8 weeks. Pre-training and post-training data were collected for sprinting times over 10 and 20 m, countermovement jump (CMJ) height, and leg stiffness (KN). Performance remained unchanged for the CON group (all p > 0.05), whereas all variables significantly improved (p < 0.05) after BRS, and all but 10-m performance improved after FRS. Compared with the CON, BRS and FRS significantly (p > 0.05) improved CMJ (Effect size [ES] = 0.67 and 0.38) and KN (ES = 0.94 and 0.69), respectively. No differences were found between training groups. The probabilities of improving sprinting performance after BRS (~70%) were on average ~10 and ~8% better than the FRS and CON groups, respectively. The BRS and FRS showed similar probabilities of improving CMJ (75 and 79%) and KN (80 and 81%), respectively, over the CON group. It seems that BRS may be a means to improve sprint performance, and regardless of direction, RS seems to be a beneficial method for improving jumping height and leg stiffness in youth male athletes. [ABSTRACT FROM AUTHOR]

The article comments on the paper "PDZ domain-binding motif regulates cardiomyocyte compartment-specific Nav1.5 channel expression and function" by D. Shy and colleagues. Topics discussed include characteristics of voltage-gated sodium channel complexes at the intercalated disk and lateral membrane, possible existence of voltage-gated channel complexes in the myocyte, and lessons learned after the publication of the Cardiac Arrhythmia Suppression Trial (CAST) findings.

The article presents an abstract of the paper "Physical Activity to Prevent Obesity in Young Children: Cluster Randomised Controlled Trial," by J. J. Reilly, L. Kelly, C. Montgomery and colleagues. A commentary for this paper was also provided. Here, the author commends the researchers for identifying ways to enhance physical activity skills of preschool children. According to her, the results of this study can be used in creating future strategies which can help prevent obesity in early childhood.

The authors comment on the article "Systematic Review of Reviews Including Animal Studies Addressing Therapeutic Interventions for Sepsis," by F. Lamontagne and colleagues, published within the issue. According to the authors, there are a number of unanswered questions in the study. There was some disagreement on whether to include certain papers and the method for deciding was not indicated. They add that there is only circumstantial evidence on the role of such reviews on how clinical trials are conducted.

Purpose: Mobility deficits and cognitive decline have been associated with cardiovascular disease (CVD) in older adults. Computerized cognitive training (CCT) interventions have reported the transfer of improvements in cognitive function to gait and mobility. The purpose of this study was to examine the effects of a 6-week CCT program on mobility in older adults with CVD. Methods: A quasi-experimental design was used. Noninstitutionalized older adults with CVD who could speak and understand English and were computer users were recruited. Participants were divided into a control group (n 5 11) and an intervention group (n5 16) that received a progressively challenging CCT program. Testing was performed at baseline and after intervention. Baseline differences were examined using Mann-Whitney U and chisquare tests. Changes in outcomes after intervention were assessed using the Wilcoxon signed-rank test. Results: Statistically significant improvements in gait speed (0.23 min/s) were found in the intervention group after intervention. No significant differences were noted in other mobility/cognitive measures. Conclusions: A transference of the effects of CCT on mobility was found in older adults with CVD with clinically meaningful improvement in gait speed after 18 CCT sessions. These results indicate the positive impact of CCT in facilitating improvements in mobility. [ABSTRACT FROM AUTHOR]