National Council for Osteopathic Research

Gonadal hormones, particularly estrogens, have been suggested to influence memory and cognitive tasks that show sex differences. Previously, we reported that male-to-female (M-F) transsexuals undergoing estrogen treatment for sex re-assignment scored higher on verbal Paired Associate Learning (PAL) than a transsexual control group awaiting estrogen treatment. The present study used a more robust design to examine further associations between estrogen and cognition. We assessed additional aspects of memory, including visual, spatial, object and location memory, other cognitive abilities that show reliable sex differences, including verbal and visual-spatial abilities, and mood variables that could mediate associations between estrogen and cognition. In addition to comparing groups of individuals on and off estrogen, we used two repeated measures designs (AB and BA). The AB group was tested prior to hormone treatment and then again after treatment had begun; the BA group was tested while on estrogen treatment and then again when hormones had been withdrawn prior to surgery. Few changes in memory or cognition were observed, and changes that were observed were not consistent across study designs. The lack of significant effects did not relate to mood changes or to the sexual orientation of participants. These findings suggest that estrogen treatment associated with sex change for M-F transsexuals has little or no influence on sex-typed aspects of cognition or memory.

The association between administered estrogen and performance on verbal memory and other cognitive tasks was examined. Male-to-female transsexuals undergoing estrogen treatment for sex reassignment (n ‫؍‬ 29) scored higher on Paired Associate Learning (PAL) compared to a similar transsexual control group, awaiting estrogen treatment (n ‫؍‬ 30) (P < 0.05). No differences between groups receiving and not receiving estrogen were detected on a control memory task (Digit Span) or on other cognitive tasks including Mental Rotations and Controlled Associations. There were no group differences in age. Group differences in mood or in general intellectual ability also did not explain the findings. Results suggest a specific influence of estrogen in men on verbal memory tasks, similar to that seen in prior studies of women. They are discussed in terms of differential processing demands of the two memory tasks and possible differences between estrogenic influences on Mental Rotations and Controlled Associations in men versus women.

Background: It is likely that people with chronic pain who have low self-efficacy have a worse prognosis. A standard, high-quality measure of self-efficacy in such populations would improve evidence, by allowing meaningful comparisons amongst subgroups and between treatments, and by facilitating pooling across studies in systematic reviews.

Background Current methodological guidelines provide advice about the assessment of sub-group analysis within RCTs, but do not specify explicit criteria for assessment. Our objective was to provide researchers with a set of criteria that will facilitate the grading of evidence for moderators, in systematic reviews. Method We developed a set of criteria from methodological manuscripts (n = 18) using snowballing technique, and electronic database searches. Criteria were reviewed by an international Delphi panel (n = 21), comprising authors who have published methodological papers in this area, and researchers who have been active in the study of sub-group analysis in RCTs. We used the Research ANd Development/University of California Los Angeles appropriateness method to assess consensus on the quantitative data. Free responses were coded for consensus and disagreement. In a subsequent round additional criteria were extracted from the Cochrane Reviewers' Handbook, and the process was repeated. Results The recommendations are that meta-analysts report both confirmatory and exploratory findings for sub-groups analysis. Confirmatory findings must only come from studies in which a specific theory/evidence based a-priori statement is made. Exploratory findings may be used to inform future/subsequent trials. However, for inclusion in the meta-analysis of moderators, the following additional criteria should be applied to each study: Baseline factors should be measured prior to randomisation, measurement of baseline factors should be of adequate reliability and validity, and a specific test of the interaction between baseline factors and interventions must be presented. Conclusions There is consensus from a group of 21 international experts that methodological criteria to assess moderators within systematic reviews of RCTs is both timely and necessary. The consensus from the experts resulted in five criteria divided into two groups when synthesising evidence: confirmatory findings to support hypotheses about moderators and exploratory findings to inform future research. These recommendations are discussed in reference to previous recommendations for evaluating and reporting moderator studies.

Background: There are now several systematic reviews of RCTs testing self-management for those with chronic musculoskeletal pain. Evidence for the effectiveness of self-management interventions in chronic musculoskeletal pain is equivocal and it is not clear for which sub-groups of patients SM is optimally effective. Aims: To systematically review randomized controlled trials of self-management for chronic musculoskeletal pain that reported predictors, i.e., 'baseline factors that predict outcome independent of any treatment effect'; moderators, i.e., 'baseline factors which predict benefit from a particular treatment'; or mediators i.e., 'factors measured during treatment that impact on outcome' of outcome. Method: We searched relevant electronic databases. We assessed the evidence according to the methodological strengths of the studies. We did meta-regression analyses for age and gender, as potential moderators. Results: Although the methodological quality of primary trials was good, there were few relevant studies; most were compromised by lack of power for moderator and mediator analyses. We found strong evidence that self-efficacy and depression at baseline predict outcome and strong evidence that pain catastrophizing and physical activity can mediate outcome from self-management. There was insufficient data on moderators of treatment. Conclusions: The current evidence suggests four factors that relate to outcome as predictors/mediators, but there is no evidence for effect moderators. Future studies of mediation and moderation should be designed with 'a priori' hypotheses and adequate statistical power.

Background: It is likely that people with chronic pain who have low self-efficacy have a worse prognosis. A standard, high-quality measure of self-efficacy in such populations would improve evidence, by allowing meaningful comparisons amongst subgroups and between treatments, and by facilitating pooling across studies in systematic reviews.

Background Current methodological guidelines provide advice about the assessment of sub-group analysis within RCTs, but do not specify explicit criteria for assessment. Our objective was to provide researchers with a set of criteria that will facilitate the grading of evidence for moderators, in systematic reviews. Method We developed a set of criteria from methodological manuscripts (n = 18) using snowballing technique, and electronic database searches. Criteria were reviewed by an international Delphi panel (n = 21), comprising authors who have published methodological papers in this area, and researchers who have been active in the study of sub-group analysis in RCTs. We used the Research ANd Development/University of California Los Angeles appropriateness method to assess consensus on the quantitative data. Free responses were coded for consensus and disagreement. In a subsequent round additional criteria were extracted from the Cochrane Reviewers' Handbook, and the process was repeated. Results The recommendations are that meta-analysts report both confirmatory and exploratory findings for sub-groups analysis. Confirmatory findings must only come from studies in which a specific theory/evidence based a-priori statement is made. Exploratory findings may be used to inform future/subsequent trials. However, for inclusion in the meta-analysis of moderators, the following additional criteria should be applied to each study: Baseline factors should be measured prior to randomisation, measurement of baseline factors should be of adequate reliability and validity, and a specific test of the interaction between baseline factors and interventions must be presented. Conclusions There is consensus from a group of 21 international experts that methodological criteria to assess moderators within systematic reviews of RCTs is both timely and necessary. The consensus from the experts resulted in five criteria divided into two groups when synthesising evidence: confirmatory findings to support hypotheses about moderators and exploratory findings to inform future research. These recommendations are discussed in reference to previous recommendations for evaluating and reporting moderator studies.

Background: There are now several systematic reviews of RCTs testing self-management for those with chronic musculoskeletal pain. Evidence for the effectiveness of self-management interventions in chronic musculoskeletal pain is equivocal and it is not clear for which sub-groups of patients SM is optimally effective. Aims: To systematically review randomized controlled trials of self-management for chronic musculoskeletal pain that reported predictors, i.e., 'baseline factors that predict outcome independent of any treatment effect'; moderators, i.e., 'baseline factors which predict benefit from a particular treatment'; or mediators i.e., 'factors measured during treatment that impact on outcome' of outcome. Method: We searched relevant electronic databases. We assessed the evidence according to the methodological strengths of the studies. We did meta-regression analyses for age and gender, as potential moderators. Results: Although the methodological quality of primary trials was good, there were few relevant studies; most were compromised by lack of power for moderator and mediator analyses. We found strong evidence that self-efficacy and depression at baseline predict outcome and strong evidence that pain catastrophizing and physical activity can mediate outcome from self-management. There was insufficient data on moderators of treatment. Conclusions: The current evidence suggests four factors that relate to outcome as predictors/mediators, but there is no evidence for effect moderators. Future studies of mediation and moderation should be designed with 'a priori' hypotheses and adequate statistical power.

To conduct a systematic review and meta-analyses to assess the effect of manual therapy interventions for healthy but unsettled, distressed and excessively crying infants and to provide information to help clinicians and parents inform decisions about care. We reviewed published peer-reviewed primary research articles in the last 26 years from nine databases (Medline Ovid, Embase, Web of Science, Physiotherapy Evidence Database, Osteopathic Medicine Digital Repository , Cochrane (all databases), Index of Chiropractic Literature, Open Access Theses and Dissertations and Cumulative Index to Nursing and Allied Health Literature). Our inclusion criteria were: manual therapy (by regulated or registered professionals) of unsettled, distressed and excessively crying infants who were otherwise healthy and treated in a primary care setting. Outcomes of interest were: crying, feeding, sleep, parent-child relations, parent experience/satisfaction and parent-reported global change. Nineteen stu...

The association between administered estrogen and performance on verbal memory and other cognitive tasks was examined. Male-to-female transsexuals undergoing estrogen treatment for sex reassignment (n ‫؍‬ 29) scored higher on Paired Associate Learning (PAL) compared to a similar transsexual control group, awaiting estrogen treatment (n ‫؍‬ 30) (P < 0.05). No differences between groups receiving and not receiving estrogen were detected on a control memory task (Digit Span) or on other cognitive tasks including Mental Rotations and Controlled Associations. There were no group differences in age. Group differences in mood or in general intellectual ability also did not explain the findings. Results suggest a specific influence of estrogen in men on verbal memory tasks, similar to that seen in prior studies of women. They are discussed in terms of differential processing demands of the two memory tasks and possible differences between estrogenic influences on Mental Rotations and Controlled Associations in men versus women.

Self-management is an established, effective approach to controlling asthma, recommended in guidelines. However, promotion, uptake and use among patients and health-care professionals remain low. Many barriers and facilitators to effective self-management have been reported, and views and beliefs of patients and health care professionals have been explored in qualitative studies. We conducted a systematic review and thematic synthesis of qualitative research into self-management in patients, carers and health care professionals regarding self-management of asthma, to identify perceived barriers and facilitators associated with reduced effectiveness of asthma self-management interventions. Electronic databases and guidelines were searched systematically for qualitative literature that explored factors relevant to facilitators and barriers to uptake, adherence, or outcomes of self-management in patients with asthma. Thematic synthesis of the 56 included studies identified 11 themes: (...

To conduct a systematic review and meta-analyses to assess the effect of manual therapy interventions for healthy but unsettled, distressed and excessively crying infants and to provide information to help clinicians and parents inform decisions about care. We reviewed published peer-reviewed primary research articles in the last 26 years from nine databases (Medline Ovid, Embase, Web of Science, Physiotherapy Evidence Database, Osteopathic Medicine Digital Repository , Cochrane (all databases), Index of Chiropractic Literature, Open Access Theses and Dissertations and Cumulative Index to Nursing and Allied Health Literature). Our inclusion criteria were: manual therapy (by regulated or registered professionals) of unsettled, distressed and excessively crying infants who were otherwise healthy and treated in a primary care setting. Outcomes of interest were: crying, feeding, sleep, parent-child relations, parent experience/satisfaction and parent-reported global change. Nineteen stu...

To provide the best possible evidence base for guiding driving decisions in Parkinson disease (PD), we performed a meta-analysis comparing patients with PD to healthy controls (HCs) on naturalistic, on-the-road, and simulator driving outcomes. Seven major databases were systematically searched (to January 2018) for studies comparing patients with PD to HCs on overall driving performance, with data analyzed using random-effects meta-analysis. Fifty studies comprising 5,410 participants (PD = 1,955, HC = 3,455) met eligibility criteria. Analysis found the odds of on-the-road test failure were 6.16 (95% confidence interval [CI] 3.79-10.03) times higher and the odds of simulator crashes 2.63 (95% CI 1.64-4.22) times higher for people with PD, with poorer overall driving ratings also observed (standardized mean differences from 0.50 to 0.67). However, self-reported real-life crash involvement did not differ between people with PD and HCs (odds ratio = 0.84, 95% CI 0.57-1.23, = 0.38). Fin...

Research has demonstrated that gonadal hormones, including oestrogen, can influence memory and cognitive tasks that show sex differences in animals and humans. Beneficial effects of oestrogen on mood have also been reported in postmenopausal women in association with Oestrogen Replacement Therapy (ERT). Male-to-Female (M-F) transsexuals offer one of the few opportunities for studying the effect of oestrogen and other cross-sex hormones on human cognitive function. The present research examined the effect of gonadal hormones on memory, cognition and mood in a transsexual population. The aim was to determine whether treatment with oestrogen and other cross-sex hormones would influence memory and cognitive abilities that show sex differences, such that males treated with oestrogen and other cross-sex hormones would perform more like females. We also examined the effect of such hormone treatment on mood. In an initial study (Chapter 2), M-F transsexuals undergoing oestrogen treatment fo...

but a high specificity of 93% and could be useful to exclude rather than identify the presence of sputum eosinophilia. Conclusion Combined testing using ACQ and BEos only identifies eosinophilia in 37% and can't replace induced sputum, but may be useful to exclude sputum eosinophilia and prospective study is warranted.