Meta-epidemiological study of publication integrity, and quality of conduct and reporting of randomized trials included in a systematic review of low back pain.

OBJECTIVE: To comprehensively describe the quality of conduct, reporting, and publication integrity characteristics for all trials included in a large Cochrane review, comparing those published by presumed predatory publishers with those published by nonpredatory publishers. DESIGN: Cross-sectional meta-epidemiological study. STUDY SELECTION: Two hundred seventy-nine studies (25,704 participants) eligible for the recent update of the "Exercise therapy for chronic low back pain" Cochrane review were included. DATA EXTRACTION: Study and manuscript characteristics, including predatory publication status and other quality and integrity characteristics were extracted along with treatment effect. RESULTS: Nine percent of trials included were in presumed predatory publications; 12% in the period since 2010. We found frequency of other concerning characteristics to range from low (eg, plagiarism, 5%) to common (eg, lack of evidence of trial registration or protocol publication [75%]; insufficient sample size [84%]) in included studies. Studies published by presumed predatory publishers consistently had inferior conduct, reporting and publication integrity characteristics. Presumed predatory publication was associated with missing conflict of interest statement (OR 7.6, 95% CI 3.0-19.1), inadequate follow-up duration (OR 11.2, 95% CI 3.7-33.7), incomplete study methods (OR 12.1, 95% CI 2.8-52.2) and baseline reporting (OR 4.3, 95% CI 1.6-11.7), and high risk of bias (OR 2.7, 95% CI 1.2-6.3). All (100%) presumed predatory publications were missing trial registrations (vs. 72%) and had inadequate sample sizes (vs. 82%). Trials published in presumed predatory journals did not appear to have inflated effect sizes. CONCLUSIONS: Predatory publishers pose a distinct challenge to the consumption and synthesis of randomized controlled trials. More work is needed in other clinical areas to understand the potential impact of randomized controlled trials published in predatory publications, and as a result, the potential impact on evidence from systematic reviews that include these studies.

Identifying the supportive care needs of men and women affected by chemotherapy-induced alopecia? A systematic review.

PURPOSE: To systematically evaluate evidence regarding the unmet supportive care needs of men and women affected by chemotherapy-induced alopecia (CIA) to inform clinical practice guidelines. METHODS: We performed a review of CINAHL, MEDLINE, PsychINFO, Scopus, the Cochrane Library (CCRT and CDSR) controlled trial databases and clinicaltrials.gov from January 1990 to June 2019 according to the Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) statement. Twenty-seven publications were selected for inclusion in this analysis. RESULTS: Included reports used qualitative (ten) and quantitative (17) studies. Across these studies men and women reported the major impact that CIA had on their psychological well-being, quality of life and body image. Hair loss had a negative impact irrespective of gender, which resulted in feelings of vulnerability and visibility of being a "cancer patient". Men and women described negative feelings, often similar, related to CIA with a range of unmet supportive care needs. CONCLUSIONS: Some patients are not well-prepared for alopecia due to a lack of information and resources to reduce the psychological burden associated with CIA. Hair loss will affect each patient and their family differently, therefore, intervention and support must be tailored at an individual level of need to optimise psychological and physical well-being and recovery. IMPLICATIONS FOR CANCER SURVIVORS: People affected by CIA may experience a range of unmet supportive care needs, and oncology doctors and nurses are urged to use these findings in their everyday consultations to ensure effective, person-centred care and timely intervention to minimise the sequalae associated with CIA.

Over view of major traumatic injury in Australia--Implications for trauma system design.

BACKGROUND: Trauma registries are known to drive improvements and optimise trauma systems worldwide. This is the first reported comparison of the epidemiology and outcomes at major centres across Australia. METHODS: The Australian Trauma Registry was a collaboration of 26 major trauma centres across Australia at the time of this study and currently collects information on patients admitted to these centres who die after injury and/or sustain major trauma (Injury Severity Score (ISS) > 12). Data from 1 July 2016 to 30 June 2017 were analysed. Primary endpoints were risk adjusted length of stay and mortality (adjusted for age, cause of injury, arrival Glasgow coma scale (GCS), shock-index grouped in quartiles and ISS). RESULTS: There were 8423 patients from 24 centres included. The median age (IQR) was 48 (28-68) years. Median (IQR) ISS was 17 (14-25). There was a predominance of males (72%) apart from the extremes of age. Transport-related cases accounted for 45% of major trauma, followed by falls (35.1%). Patients took 1.42 (1.03-2.12) h to reach hospital and spent 7.10 (3.64-15.00) days in hospital. Risk adjusted length of stay and mortality did not differ significantly across sites. Primary endpoints across sites were also similar in paediatric and older adult (>65) age groups. CONCLUSION: Australia has the capability to identify national injury trends to target prevention and reduce the burden of injury. Quality of care following injury can now be benchmarked across Australia and with the planned enhancements to data collection and reporting, this will enable improved management of trauma victims.

Effect of cervicolumbar coupling on spinal reflexes during cycling after incomplete spinal cord injury.

Spinal networks in the cervical and lumbar cord are actively coupled during locomotion to coordinate arm and leg activity. The goals of this project were to investigate the intersegmental cervicolumbar connectivity during cycling after incomplete spinal cord injury (iSCI) and to assess the effect of rehabilitation training on improving reflex modulation mediated by cervicolumbar pathways. Two studies were conducted. In the first, 22 neurologically intact (NI) people and 10 people with chronic iSCI were recruited. The change in H-reflex amplitude in flexor carpi radialis (FCR) during leg cycling and H-reflex amplitude in soleus (SOL) during arm cycling were investigated. In the second study, two groups of participants with chronic iSCI underwent 12 wk of cycling training: one performed combined arm and leg cycling (A&L) and the other legs only cycling (Leg). The effect of training paradigm on the amplitude of the SOL H-reflex was assessed. Significant reduction in the amplitude of both FCR and SOL H-reflexes during dynamic cycling of the opposite limbs was found in NI participants but not in participants with iSCI. Nonetheless, there was a significant reduction in the SOL H-reflex during dynamic arm cycling in iSCI participants after training. Substantial improvements in SOL H-reflex properties were found in the A&L group after training. The results demonstrate that cervicolumbar modulation during rhythmic movements is disrupted in people with chronic iSCI; however, this modulation is restored after cycling training. Furthermore, involvement of the arms simultaneously with the legs during training may better regulate the leg spinal reflexes. NEW & NOTEWORTHY This work systematically demonstrates the disruptive effect of incomplete spinal cord injury on cervicolumbar coupling during rhythmic locomotor movements. It also shows that the impaired cervicolumbar coupling could be significantly restored after cycling training. Actively engaging the arms in rehabilitation paradigms for the improvement of walking substantially regulates the excitability of the lumbar spinal networks. The resulting regulation may be better than that obtained by interventions that focus on training of the legs only.

Evidence-based practice to improve outcomes of anterior cruciate ligament reconstruction.

Recent studies of anatomic anterior cruciate ligament (ACL) reconstruction have considered native knee anatomy and biomechanical function, and emphasized the long-term goals of protecting knee health and preventing the development of symptomatic ACL-deficient degenerative arthrosis. Validated and reproducible examination maneuvers are necessary for accurate diagnosis and appraisal of surgical interventions. Appropriately powered expertise-based trials should be emphasized to minimize bias, enhance validity, and reduce crossover. Best practice rehabilitation protocols can guide postoperative care while minimizing heterogeneity within studies. Functional outcome scores should be sensitive, responsive, and able to reliably detect small changes.

The experience of surviving life-threatening injury: a qualitative synthesis.

BACKGROUND: To summarize and synthesize research that explored the experience of surviving life-threatening injury in adolescents, young persons and adults. METHODS: Informed by systematic literature review strategies, a description of the experience of individuals who survived life-threatening injury was sought by reviewing 13 studies with qualitative data on the phenomena. Data were managed using NVivo software and synthesized using thematic analysis to elicit meaning. RESULTS: The review synthesized a substantial number (n=273) of participant experiences of traumatic surviving life-threatening injury and revealed that during the initial 3 years following life-threatening injury, the individual goes through a shifting, iterative process in order to reconstruct various aspects of their injury and themselves, including mental, emotional, spiritual, physical and relational facets. Three major themes were illuminated: a time of chaos, negotiating injury and reconciling injury. In order to navigate through the experience of injury, family members were key sources of affirmation and support in anchoring the person to their life, in reconstructing themselves in the aftermath of injury and in coming to terms with the impacts of injury. CONCLUSION: This qualitative synthesis describes the iterative process individuals go through following life-threatening injury and the overwhelming need to reconstruct aspects of self as a way to create meaning. It demonstrates the need to gain further understanding of the influence of the family in recovery from injury and indicates that education is required to provide practical strategies to assist clinicians to develop appropriate and relevant patient goals and expectations.

How will area regeneration impact on health? Learning from the GoWell study.

OBJECTIVES: To establish the theoretical and perceived links between area regeneration and health in a Scottish context in order to inform a comprehensive evaluation of regeneration activity. The evaluation will include health outcomes. STUDY DESIGN: Mixed method combining and comparing key informant interviews with policy analysis. METHODS: Analysis of identified links between elements of regeneration activity and health was undertaken of published policies and strategies which described regeneration for Scotland and the city of Glasgow. Interviews with key informants explored their understanding of the inputs to regeneration, and the pathways between regeneration and better health outcomes. RESULTS: The policy analysis and interviews revealed a holistic approach to a complex problem. Both identified a need for action to improve housing, neighbourhoods and services, education, employment, community participation and social issues. Improved health was identified as an emergent property. Interviewees identified a need to augment the established structural components with a more person-centred approach, fostering confidence and higher aspirations, but were uncertain how to achieve this. The interviews revealed a lack of confidence that current practice would deliver all the components of the holistic model. CONCLUSIONS: A holistic model of regeneration appears to inform policy, but is proving difficult to deliver. Improved health and reduced health inequalities were not primary objectives but emergent properties. In light of this, the ability of regeneration to actively maximize positive health impacts, particularly if this requires focused planning or opportunity costs to other activities, is questioned.

Loss of heterozygosity associated with uniparental disomy in breast carcinoma.

Loss of heterozygosity is commonly assumed to be due to deletion of the appropriate genomic region in one chromosome within a neoplastic cell but may be due to other mechanisms such as mitotic non-disjunction or somatic recombination leading to uniparental heterodisomy. We chose to study the genomic regions surrounding the p53 and RB1 tumor suppressor genes in breast carcinoma to evaluate the different mechanisms that could mediate loss of heterozygosity. A microsatellite analysis of polymorphic markers in 50 breast cancer samples showed loss of heterozygosity for at least 1 of the 10 markers analyzed in 50% of the tumors studied, and an overall 8.47% of the informative loci showed loss of heterozygosity. All of the cases with loss of heterozygosity were further analyzed for gene copy number of the tumor suppressor genes RB1 and p53 by fluorescence in situ hybridization of either tumor touch preparations or microdissected tumor nuclei with specific genomic probes. Surprisingly, all samples showed the presence of both copies of tumor suppressor genes, including 4/50 cases showing loss of heterozygosity of tumor suppressor gene-spanning markers. One of the 4 cases showed loss of heterozygosity of markers spanning a distance of 6 cM over the RB1 gene, with normal copy numbers of the gene. Three other cases showed loss of heterozygosity of markers within the tumor suppressor gene (RBI or p53) and at least one other spanning marker. No cases showed a simultaneous reduction to homozygosity of markers both near the tumor suppressor gene and distal loci. We suggest that the presence of both copies of the tumor suppressor gene in the cases with loss of heterozygosity of spanning markers and internal markers for that tumor suppressor gene could be explained by somatic recombination resulting in uniparental disomy, but not mitotic nondisjunction or deletion. As the mechanism for physical deletion of a chromosome may be different from those mediating somatic recombination, study of this phenomenon may identify different pathways of genomic instability that may be of diagnostic or treatment significance in breast or other cancers, particularly in those treatments based upon DNA-altering agents.

The Dream Property Scale: an exploratory English version.

Our goal is to develop an English version of the Dream Property Scale (DPS-E) based on the original normed scale in Japan (DPS-J). Factor analyses extracted four factors (Emotionality, Rationality, Activity, and Impression) and its factor structure was apparently similar to the DPS-J. The DPS-E was also shown to be related to EEG power spectral values. These results indicate that the DPS-E may provide an exploratory basis for a reliable and valid tool for capturing and quantifying the properties of dream experiences that could reflect physiological activities without the intervention of experimenters. We suggest that the DPS-E will develop into a useful tool to help clarify dream production mechanisms by further investigation.

The effect of exercise on anterior-posterior translation of the normal knee and knees with deficient or reconstructed anterior cruciate ligaments.

Exercise may result in increased laxity in the knee. Anterior translation in 40 normal knees, 33 consecutive anterior cruciate ligament-deficient knees, and 30 randomly chosen anterior cruciate ligament-reconstructed knees was measured using the KT-1000 arthrometer before and after the participants ran for 15 minutes on a neutral-incline treadmill. A single observer blinded to the status of each knee tested all participants. There was a significant increase in anterior translation in the normal (mean, 0.75 mm), anterior cruciate ligament-deficient (mean, 0.62 mm), and anterior cruciate ligament-reconstructed knees (mean, 0.25 mm) after exercise. In addition, the amount of anterior translation after exercise was significantly different when these groups were compared with each other. Post hoc analysis using Tukey's procedure indicated that anterior translation in the anterior cruciate ligament-reconstructed knee was significantly less than in the normal and anterior cruciate ligament-deficient knees. Therefore, repetitive loading exercise contributes to an increase in anterior translation in normal, anterior cruciate ligament-deficient, and anterior cruciate ligament-reconstructed knees, and the anterior cruciate ligament-reconstructed knee does not respond to repetitive loading in the same manner as a normal knee.

Recognition of sleep paralysis among normal adults in Canada and in Japan.

There were no differences between Canada and Japan in the prevalence and symptoms of sleep paralysis (SP), but many more Canadians considered SP to be a dream. The difference was considered to be derived from the fact that there is a common expression for SP in Japan but there is not one in Canada. Then, we investigated why there are individuals who consider SP to be a dream and others who do not, and found that many Japanese who regarded it as a dream did not report the symptom of 'unable to move', while in Canada, self-evaluation of spirituality was different between the two groups.

Exercise stimulates neovascularization in occluded muscle without affecting bFGF content.

PURPOSE: This study was conducted to determine whether exercise-induced improvements in capillarity in muscle with peripheral arterial insufficiency (PAI) was accompanied by endothelial cell mitosis, and whether that response could be explained by changes in the expression of basic fibroblast growth factor (bFGF), a known mitogen. METHODS: After bilateral ligation of femoral arteries, Sprague-Dawley rats either remained sedentary or participated in a treadmill running protocol. Running time to exhaustion at each session was recorded. On days 1, 2, 3, 5, and 7 of the experimental period, trained-ligated and sedentary-ligated animals were euthanized, and segments of muscle from the gastrocnemius were obtained. Capillarity was determined with histochemistry, and endothelial cell mitotic activity (cell proliferation) was assayed via nuclear uptake of 5'-bromo-2'-deoxyuridine (BrdU), an analog of thymidine. Content of endogenous bFGF was assessed with immunoblotting techniques. RESULTS: Exercise training resulted in augmented function of PAI affected muscle as evidenced by a nearly threefold increase in running time until exhaustion. Trained-ligated muscle demonstrated significantly (P < 0.05) greater capillarity than sedentary-ligated muscle. Vascular remodeling elicited by exercise included the formation of new capillaries (angiogenesis) as indicated by enhanced endothelial cell proliferation at days 3, 5, and 7 of the study. However, exercise training did not alter the content of bFGF in occluded muscle. CONCLUSION: In muscle with PAI, exercise training improved functional capacity and capillarity. Angiogenesis was confirmed by the increased mitotic activity of endothelial cells. However, the content of bFGF, a potent angiogenic factor, was not altered. Thus, exercise-induced angiogenesis in PAI affected muscle is not dependent upon increased expression of endogenous bFGF.

Students' attitudes towards computer testing in a basic science course.

OBJECTIVES: The introduction of computerized testing offers several advantages for test administration, however, little research has examined students' attitudes toward computerized testing. This paper, reports the attitudes of 202 students in a first year cell biology and histology course toward computerized testing and its influence on their study habits over a three year period. DESIGN AND METHODS: Multiple choice and image-based extra credit examinations and summative image-based examinations have been successfully administered in the course. The results indicate that students readily accept computer exams and that their study habits were influenced in a positive manner by the computer administered extra-credit examinations. RESULTS: Our results provide further evidence that medical students like the use of computer administered examinations and that the examinations may actually accentuate the learning experience.

Lifestyle modifications to prevent and control hypertension. 2. Recommendations on obesity and weight loss. Canadian Hypertension Society, Canadian Coalition for High Blood Pressure Prevention and Control, Laboratory Centre for Disease Control at Health Canada, Heart and Stroke Foundation of Canada.

OBJECTIVE: To provide updated, evidence-based recommendations concerning the effects of weight loss and maintenance of healthy weight on the prevention and control of hypertension in otherwise healthy adults (except pregnant women). OPTIONS: The main options are to attain and maintain a healthy body weight (body mass index [BMI] 20-25 kg/m2) or not to do so. For those at risk for hypertension, weight loss and maintenance of healthy weight may prevent the condition. For those who have hypertension, weight loss and maintenance of healthy weight may reduce or obviate the need for antihypertensive medications. OUTCOMES: The health outcome considered was change in blood pressure. Because of insufficient evidence, no economic outcomes were considered. EVIDENCE: A MEDLINE search was conducted for the years 1992-1996 with the terms hypertension and obesity in combination and antihypertensive therapy and obesity in combination. Other relevant evidence was obtained from the reference lists of the articles identified, from the personal files of the authors and through contacts with experts. The articles were reviewed, classified according to study design and graded according to level of evidence. VALUES: A high value was placed on the avoidance of cardiovascular morbidity and premature death caused by untreated hypertension. BENEFITS, HARMS AND COSTS: Weight loss and the maintenance of healthy body weight reduces the blood pressure of both hypertensive and normotensive people. The indirect benefits of a health body weight are well known. The negative effects of weight loss are primarily the frustrations associated with attaining and maintaining a healthy weight. The costs associated with weight loss programs were not measured in the studies reviewed. RECOMMENDATIONS: (1) It is recommended that health care professionals determine weight (in kilograms), height (in metres) and BMI for all adults. (2) To reduce blood pressure in the population at large, it is recommended that Canadians attain and maintain a healthy BMI (20-25). (3) All overweight hypertensive patients (BMI greater than 25) should be advised to reduce their weight. VALIDATION: These recommendations are similar to those of the World Hypertension League, the National High Blood Pressure Education Program Working Group on Primary Prevention of Hypertension, the Canadian Hypertension Society and the Canadian Coalition for High Blood Pressure Prevention and Control. They have not been clinically tested. SPONSORS: The Canadian Hypertension Society, the Canadian Coalition for High Blood Pressure Prevention and Control, the Laboratory Centre for Disease Control at Health Canada, and the Heart and Stroke Foundation of Canada.

EEG spectral analysis of the sleep-onset period in narcoleptics and normal sleepers.

The sleep-onset period of 10 drug-free patients with narcolepsy-cataplexy and 10 normals matched for age and gender was investigated using the multiple sleep latency test to elicit episodes of intentional sleep onset. Spectral analyses were calculated for delta, theta, alpha, sigma, and beta frequencies using 5-second epochs beginning at lights-out and continuing until the first 2 minutes of stage 2 or REM sleep were reached, or until 20 minutes had elapsed. The sleep-onset period was divided into quartiles, and mean root mean square (RMS) amplitude within each quartile was calculated. Mean delta amplitude was significantly higher across the sleep-onset period of narcoleptic REM naps and narcoleptic stage 2 naps compared to the sleep-onset period of normal stage 2 naps or normal stage 1 naps. Mean theta amplitude was significantly higher for narcoleptic REM naps compared to normal stage 1 naps, and tended to be higher for narcoleptic stage 2 naps compared to normal stage 1 naps. Mean alpha amplitude was significantly lower for narcoleptic REM naps and narcoleptic stage 2 naps compared to normal naps containing just stage 1. Mean sigma amplitude was significantly lower for narcoleptic REM naps compared to normal stage 1 naps, and tended to be lower for narcoleptic REM naps compared to normal stage 2 naps. Mean beta amplitude did not differ between the narcoleptic and normal sleep-onset process. These findings support the existence of electrophysiologic differences within the microstructure of the process of sleep entry in narcoleptics and normals.

Determinants of left ventricular mass in early hypertension.

One hundred seventy-six unmedicated mildly hypertensive subjects (113 men, 63 women) underwent M-mode echocardiography to determine left ventricular mass (LVM) and relative wall thickness (RWT), 24-h ambulatory blood pressure monitoring, and completed standardized questionnaires measuring marital and job stress. Subjects were aged 46 +/- 9 years old; 45.4% had daytime diastolic blood pressure < 90 mm Hg; 96.1% of LVM results were in the normal range. We found that neither marital distress nor job strain was a determinant of LVM. However, a segmental regression approach revealed inflection points of 131 mm Hg systolic daytime blood pressure and 83 and 87 mm Hg nighttime diastolic blood pressure in the relation between LVM and RWT, respectively, and ambulatory BP. In addition, we found that the variability of LVM was best explained by indexing LVM by height, rather than body surface area.

Captopril and angiotensin II receptor antagonist therapy in a pacing model of heart failure.

Twenty-four splenectomized dogs were subjected to rapid right ventricular pacing (RRVP) at 250 beats/min for five weeks. During the final three weeks, four groups six dogs were untreated or treated with captopril alone, with the angiotensin II type 1 (AT1) receptor antagonist L158,809 alone or with the two drugs combined by constant intravenous infusion. Hemodynamic studies were carried out during light anesthesia at baseline, and after two and five weeks of pacing. Total vascular capacitance and stressed blood volume were calculated from the mean circulatory filling pressure during transient circulatory arrest after acetylcholine administration at three different circulating volumes. Central blood volume and cardiac output were measured by thermodilution. Severe heart failure was present in the untreated group after five weeks of RRVP, characterized by low cardiac output and total vascular capacitance, high right atrial and pulmonary capillary wedge and mean circulatory filling pressure, plus increased stressed and central blood volumes. While L158,809 had not effect, captopril alone or combined with L158,809 ameliorated the reduction in total vascular capacitance, and reduced right atrial and mean circulatory pressure and stressed blood volumes. Combined therapy reduced pulmonary capillary wedge pressure. Thus, angiotensin-converting enzyme inhibition with captopril was effective in this model of chronic low output heart failure, whereas AT1 receptor antagonism was not.