Reconsidering assent for randomised control trials in education: Ethical and procedural concerns

A capacity model of mindfulness is adopted to differentiate the cognitive faculty of mindfulness from the metacognitive processes required to cultivate this faculty in mindfulness training. The model provides an explanatory framework incorporating both the developmental progression from focussed attention to open monitoring styles of mindfulness practice, along with the development of equanimity and insight. A standardised technique for activating these processes without the addition of secondary components is then introduced. Mindfulness-based interventions currently available for use in randomised control trials introduce components ancillary to the cognitive processes of mindfulness, limiting their ability to draw clear causative inferences. The standardised technique presented here does not introduce such ancillary factors, rendering it a valuable tool with which to investigate the processes activated in this practice.

Efficacy of NSAIDs versus radiotherapy for heterotopic ossification prophylaxis following total hip arthroplasty in high-risk patients: a systematic review and meta-analysis

Hip International ◽

10.1177/1120700021991115 ◽

2021 ◽

pp. 112070002199111

Author(s):

Jacob Shapira ◽

Mitchell J Yelton ◽

Jeffery W Chen ◽

Philip J Rosinsky ◽

David R Maldonado ◽

...

Keyword(s):

Systematic Review ◽

High Risk ◽

Total Hip Arthroplasty ◽

Hip Arthroplasty ◽

Meta Analysis ◽

Comparable Efficacy ◽

Total Hip ◽

High Risk Patients ◽

Randomised Control Trials ◽

Risk Patients

Background: The aims of this systematic review were: (1) to investigate the prophylactic effect of radiotherapy (RT) and NSAIDs in high-risk patients following total hip arthroplasty (THA); and (2) to compare the efficacy of non-selective and COX-II selective NSAIDs in preventing post-THA HO, utilising a meta-analysis of randomised control studies. Methods: The PubMed, Embase, and Cochrane Databases were searched for articles regarding HO following THA in March 2019. Studies were included if they contained data regarding HO incidence after THA or contained data regarding HO prophylaxis comparison of NSAIDs and/or RT in terms of dosage or duration. Results: 24 studies reported on populations that were not at high-risk for HO. These studies reported between 47.3% and 90.4% of their patient populations had no HO formation; between 2.8% and 52.7% had mild formation; and between 0.0% and 10.4% had severe formation. A total of 13 studies reported on populations at high-risk for HO. Studies analysing RT in high-risk patients reported between 28.6% and 97.4% of patients developed no HO formation; between 1.9% and 66.7% developed mild HO formation; and between 0.0% and 11.9% developed severe HO formation. Studies analysing NSAID treatment among high-risk populations reported between 76.6% and 88.9% had no HO formation; between 11.1% and 23.4% had mild HO formation, and between 0.0% and 1.8% had severe HO formation. 9 studies were identified as randomised control trials and subsequently used for meta-analysis. The relative risk for COX-II in developing any HO after THA was not significantly different compared to non-selective NSAIDs (RR 1.00; CI, 0.801–1.256; p = 0.489). Conclusions: NSAIDs prophylaxis for HO may have better efficacy than RT in high-risk patients following THA. Non-selective and COX-II selective NSAIDs have comparable efficacy in preventing HO. Factors such as medical comorbidities and side-effect profile should dictate the prophylaxis recommendation.

The effect of exercise on quality of life and activities of daily life in frail older adults: A systematic review of randomised control trials

Experimental Gerontology ◽

10.1016/j.exger.2021.111287 ◽

2021 ◽

Vol 147 ◽

pp. 111287

Author(s):

Evan Campbell ◽

Fanny Petermann-Rocha ◽

Paul Welsh ◽

Carlos Celis-Morales ◽

Jill P. Pell ◽

...

Keyword(s):

Quality Of Life ◽

Systematic Review ◽

Older Adults ◽

Daily Life ◽

Frail Older Adults ◽

Activities Of Daily Life ◽

Randomised Control Trials

Modelling the Reallocation of Time Spent Sitting into Physical Activity: Isotemporal Substitution vs. Compositional Isotemporal Substitution

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18126210 ◽

2021 ◽

Vol 18 (12) ◽

pp. 6210

Author(s):

Gregory J. H. Biddle ◽

Joseph Henson ◽

Stuart J. H. Biddle ◽

Melanie J. Davies ◽

Kamlesh Khunti ◽

...

Keyword(s):

Low Density Lipoprotein ◽

Density Lipoprotein ◽

Lipoprotein Cholesterol ◽

Future Research ◽

Cardiometabolic Health ◽

Low Density Lipoprotein Cholesterol ◽

Cross Sectional ◽

Randomised Control Trials ◽

Data Driven Decisions

Isotemporal substitution modelling (ISM) and compositional isotemporal modelling (CISM) are statistical approaches used in epidemiology to model the associations of replacing time in one physical behaviour with time in another. This study’s aim was to use both ISM and CISM to examine and compare associations of reallocating 60 min of sitting into standing or stepping with markers of cardiometabolic health. Cross-sectional data collected during three randomised control trials (RCTs) were utilised. All participants (n = 1554) were identified as being at high risk of developing type 2 diabetes. Reallocating 60 min from sitting to standing and to stepping was associated with a lower BMI, waist circumference, and triglycerides and higher high-density lipoprotein cholesterol using both ISM and CISM (p < 0.05). The direction and magnitude of significant associations were consistent across methods. No associations were observed for hemoglobin A1c, total cholesterol, or low-density lipoprotein cholesterol for either method. Results of both ISM and CISM were broadly similar, allowing for the interpretation of previous research, and should enable future research in order to make informed methodological, data-driven decisions.

Mendelian randomisation for psychiatry: how does it work, and what can it tell us?

Molecular Psychiatry ◽

10.1038/s41380-021-01173-3 ◽

2021 ◽

Author(s):

Robyn E. Wootton ◽

Hannah J. Jones ◽

Hannah M. Sallis

Keyword(s):

Risk Factors ◽

Mental Illness ◽

Risk Factor ◽

Low Cost ◽

Sensitivity Analyses ◽

Mendelian Randomisation ◽

Naturally Occurring ◽

Complementary Approach ◽

Randomised Control Trials ◽

Successful Prevention

AbstractThe successful prevention of mental illness relies upon the identification of causal, modifiable risk factors. However, observational evidence exploring such risk factors often produces contradictory results and randomised control trials are often expensive, time-consuming or unethical to conduct. Mendelian randomisation (MR) is a complementary approach that uses naturally occurring genetic variation to identify possible causal effects between a risk factor and an outcome in a time-efficient and low-cost manner. MR utilises genetic variants as instrumental variables for the risk factor of interest. MR studies are becoming more frequent in the field of psychiatry, warranting a reflection upon both the possibilities and the pitfalls. In this Perspective, we consider several limitations of the MR method that are of particular relevance to psychiatry. We also present new MR methods that have exciting applications to questions of mental illness. While we believe that MR can make an important contribution to the field of psychiatry, we also wish to emphasise the importance of clear causal questions, thorough sensitivity analyses, and triangulation with other forms of evidence.

Sertraline as a treatment for PTSD: a systematic review and meta-analysis

Irish Journal of Psychological Medicine ◽

10.1017/s0790966700008478 ◽

2004 ◽

Vol 21 (3) ◽

pp. 100-103 ◽

Cited By ~ 7

Author(s):

Paul Mooney ◽

Janette Oakley ◽

Michael Ferriter ◽

Raymond Travers

Keyword(s):

Systematic Review ◽

Post Traumatic Stress Disorder ◽

Traumatic Stress ◽

Meta Analysis ◽

Case Series ◽

Group Differences ◽

Post Traumatic Stress ◽

Relevant Research ◽

Randomised Control Trials ◽

Post Traumatic

AbstractObjective: Post-traumatic stress disorder (PTSD) is one of the most prevalent psychological disorders. Methods to alleviate its symptoms range from ‘talking therapies’ to pharmaceutical interventions. Our objective was to carry out a systematic review of the effectiveness of sertraline, an SSRI, as a treatment for PTSD.Method: Databases were searched to identify relevant research on sertraline as a treatment for PTSD.Results: Five randomised control trials were identified, along with seven open trials and case series studies.Conclusions: The review and meta-analysis supported the use of sertraline for PTSD though further research on sub-group differences (eg. gender) is required.

CBT for adolescent pathological gambling – lessons from adult research

Irish Journal of Psychological Medicine ◽

10.1017/s0790966700000458 ◽

2009 ◽

Vol 26 (3) ◽

pp. 140-146 ◽

Cited By ~ 2

Author(s):

Ciaran Clarke ◽

Norbertas Skokauskas

Keyword(s):

Pathological Gambling ◽

Cognitive Behavioural Therapy ◽

Case Series ◽

Behavioural Therapy ◽

Addictive Behaviors ◽

Hand Search ◽

Intention To Treat ◽

Cognitive Behavioural ◽

Long Term Follow Up ◽

Randomised Control Trials

AbstractObjectives:Features of gambling, particularly among young people have changed over the past decade and, while there are no data from Ireland, there are suggestions from those working in the field that pathological gambling is increasing among adolescents. Relatively little is known about the effective treatment of pathological gambling in adolescents. This paper aims to review research in cognitive behavioural treatments with a view to their application in adolescents. Research among adolescence is given prominence when this is available.Methods:The methodology comprised a literature search of Medline, Psycinfo, and EMBASE databases, using the search terms: ‘cognitive behavioural therapy’; ‘gambling; ‘psychology’; ‘epidemiology’; ‘adolescent’; ‘motivation’; ‘effectiveness’; ‘outcome’; ‘relapse’; and ‘internet’. In addition, a hand search ofClinical Psychological Reviews, Journal of Gambling Studies, Addiction, Psychology of Addictive Behaviors, and International Gambling Studies(1997-2007) was performed.Results:A total of 23 studies comprising various cognitive and behavioural approaches were identified, all but three of them confined to adult subjects. Study methodology and quality varied greatly, with many case studies or small case series, and only three randomised control trials. None used an intention-to-treat analysis, and there was little long-term follow-up. Almost ail indicated, with more or less evidence, that cognitive behavioural strategies might be beneficial.Conclusions:Many varieties and modifications of cognitive behavioural therapy have been applied to pathological gambling, though there are few studies of any psychological treatments for adolescent gamblers. Methodological problems surround much of the research. Notwithstanding these reservations cognitive behavioural approaches seem to offer promise in managing this serious problem.

Choice, voice and collaboration: using preference accommodation and feedback in trauma therapy

Mental Health and Social Inclusion ◽

10.1108/mhsi-06-2021-0032 ◽

2021 ◽

Vol ahead-of-print (ahead-of-print) ◽

Author(s):

Daryl Mahon

Keyword(s):

Empirical Studies ◽

Relative Effectiveness ◽

Case Vignette ◽

Trauma Therapy ◽

Content Type ◽

Choice Preference ◽

Randomised Control Trials ◽

Trauma Informed ◽

Informed Treatment ◽

Meta Analyses

Purpose Organisations are increasingly understanding the need to be trauma informed. However, how trauma therapies in such organisations apply the principles of choice and collaboration is less understood. The present paper applies two trans-theoretical methods for involving clients in their therapy through preference accommodation and feedback-informed treatment (FIT). A case vignette is provided demonstrating how to involve clients in trauma therapy by listening to their preferences, needs and by providing them with a voice on their experience of the process and outcome of care. Design/methodology/approach A focused review of the literature was conducted, with relevant randomised control trials, systematic reviews and meta-analyses sourced. The resulting information informed the design and this model for working with those in trauma therapy. Findings The research regarding trauma-specific therapies being more effective is far from conclusive. At the same time, early attrition and negative outcomes make up a large percentage of those seeking therapy. Using preference accommodation and FIT is one possibly way to mitigate against these experiences in therapy and to provide choice, preference and collaboration consisting with the principles of trauma-informed approaches. Research limitations/implications Methods to improve the experiences of those seeking trauma therapy have been identified and discussed. According to the author’s knowledge, this is the first known paper aligning trauma therapy and trauma-informed approaches with preference accommodation and FIT. Future empirical studies may wish to examine the relative effectiveness of this approach. Practical implications Methods to improve outcomes for those seeking trauma therapy are at the disposal of practitioners. Improving outcomes, while also providing choice, voice and collaboration is a clinical setting. Originality/value This is a novel paper adding to value and extending how practitioners can use principles of trauma-informed approaches within trauma therapy.

Prisoner’s insomnia prevalence, insomnia associated factors and interventions with sleep as an outcome: a review and narrative analysis

International Journal of Prisoner Health ◽

10.1108/ijph-01-2021-0014 ◽

2021 ◽

Vol ahead-of-print (ahead-of-print) ◽

Author(s):

Chris Griffiths ◽

Farah Hina

Keyword(s):

Narrative Analysis ◽

Associated Factors ◽

Behavioural Therapy ◽

Post Traumatic Stress ◽

Content Type ◽

Cognitive Behavioural ◽

High Prevalence ◽

Randomised Control Trials ◽

Post Traumatic ◽

Anxiety Depression

Purpose Insomnia is highly prevalent in prisoners. The purpose of this paper is a review of research evidence on interventions with sleep as an outcome (2000 to 2020) and rates of insomnia prevalence and associated factors in prisons (2015 to 2020). Design/methodology/approach An internet-based search used Medline, PubMed, PsycINFO (EBSCOhost), Embase, Web of Science and Scopus. Seven interventions and eight sleep prevalence or sleep-associated factor papers were identified. Findings Intervention research was very limited and the quality of the research design was generally poor. Interventions such as cognitive behavioural therapy for insomnia (CBT-I), yoga and mindfulness can be beneficial in a prison setting. This review identified a high prevalence of insomnia in prisons across the world, which was supported by recent evidence. Factors associated with insomnia include anxiety, depression, post-traumatic stress disorder, personality disorder and pain. Research limitations/implications There is a need for appropriately powered randomised control trials of CBT-I in prisons and a need to use objective measures of sleep quality. Originality/value Due to a lack of an up-to-date review, this paper fulfils the need for a review of the evidence on interventions in prison settings with sleep as an outcome, rates of insomnia prevalence and associated factors in prisons.

Management of hypertensive disorders in pregnancy in Black women: a systematic review

10.21203/rs.3.rs-191253/v1 ◽

2021 ◽

Author(s):

Jeeva John ◽

Gwenetta Curry

Keyword(s):

Systematic Review ◽

Black Women ◽

Randomised Control Trial ◽

Free Text ◽

Hypertensive Disorders ◽

Black Patients ◽

Study Results ◽

Hypertensive Disorders In Pregnancy ◽

Randomised Control Trials ◽

In Pregnancy

Abstract Background: Black women are four times more likely to die than White women due to complications during pregnancy or childbirth in the U.K. This cohort are also more prone to Hypertensive Disorders in Pregnancy (HDP). Outside of pregnancy, there are race based differences in the management of hypertension as Calcium-Channel Blockers (CCB) 9 are more effective in reducing blood pressure in Black patients. It is unclear whether these differences in anti-hypertensive management extend to the management of hypertension in pregnancy. The primary objective was to address this gap in evidence by undertaking a systematic review of all randomised control trials investigating pharmacological management of HDP to assess whether CCBs are the most effective anti-hypertensive agent in Black pregnant women. Methods: The following electronic databases were searched: PubMed, MEDLINE and Embase. We used MeSH and free text terms in conjunction to increase sensitivity to potentially relevant studies. Inclusion criteria included: (1) study involved treatment of HDP; (2) study was of a randomised control trial design; (3) one of the treatment arms involved CCBs and (4) English full-text. Information regarding baseline participant data, type of anti-hypertensive, and clinical outcomes was extracted from each study. Results: This review highlighted four randomised control trials, which published race or ethnicity demographics, with only one trial that stratified HDP outcomes by ethnicity. Conclusions: There is a lack of evidence to draw definite conclusions as to whether CCBs are the most effective anti-hypertensive agent for Black patients with HDP, highlighting the need for further research in this area. However, this review demonstrates some evidence to support the hypothesis that CCBs could be more effective in the management of HDP in Black patients and that Labetalol, which is the current first-line management of HDP, may not represent the gold standard of treatment in this cohort.