Transparent Reporting Of Evaluations With Nonrandomized Designs Research Articles

Physical therapy interventions for people experiencing homelessness to improve pain and self-perceived health status

BackgroundHomeless shelters have emerged as components of the social services network, playing an important role in providing health care to the homeless population. The aim of this study was to evaluate an individualized physical therapy intervention for people experiencing homelessness and to determine the relationship between self-perceived variables.MethodsPre and post study, setting at the “Santa y Real Hermandad de Nuestra Señora del Refugio y Piedad” homeless shelter in Zaragoza, Spain. Participants were people experiencing homelessness with musculoskeletal disorders who attended a physical therapy service at shelter facilities. A physical therapy program was implemented including health education, exercise and manual therapy, electrotherapy, thermotherapy and bandaging. Demographic variables (age and gender), nationality, employment situation, educational level, pain location, number of painful areas, feeling of loneliness (3-Item Loneliness Scale; values from 3 to 9), pain intensity (Numerical Pain Rating Scale [NPRS]; from 0 to 10) and self-perceived health (Clinical Global Impression [CGI]; from 1 to 7).ResultsSixty-four homeless people (age of 46.4 ± 10.9 years) participated in the study. Musculoskeletal pain was reported by 98.4% of subjects, with moderate pain intensities (6.1), and 48.4% presenting with pain at multiple sites. Perceptions of loneliness were low (3.7 ± 2.5) and self-perceived health status was moderately ill (3.5 ± 1.7). Positive significant correlations were identified between pain intensity and self-perceived health. The average number of sessions was 1.5 (± 0.8), with manual therapy (35.6%) followed by health education (23.5%) being the most frequently used techniques. Both pain and self-perceived health improved after treatment, even following a brief intervention.ConclusionsThis study demonstrates the potentially negative impact of untreated pain on the self-perceived health of homeless individuals with musculoskeletal disorders that should be targeted for consideration. The findings suggest that a paradigm shift in pain management, including a physical therapy service in shelters, is needed to address the rehabilitation demands of these individuals in a real-life context. This study was approved by the Aragon Ethics Committee (PI19/438) and performed according to the Transparent Reporting of Evaluations with Nonrandomized Designs (TREND) statement.

A Structured Skin Care Protocol for Preventing and Treating Incontinence-associated Dermatitis in Critically Ill Patients.

To examine the effectiveness of a structured skin care protocol for preventing and treating incontinence-associated dermatitis (IAD) in critically ill patients. Participants were drawn from the ICUs of three teaching hospitals between January 2016 and December 2017. Patients were eligible if they were ≥18 years old, had idiopathic fecal incontinence, had diarrhea but were unable to sense it, and were expected to stay in the ICU for at least 72 hours after developing incontinence. A total of 143 patients were enrolled: 79 in the experimental group and 64 in the control group. In the first phase of the study, routine skin care measures were used; in the second phase, three ICU caregivers were trained to provide a structured skin care protocol. Trained research team members conducted the data collection and analysis. The TREND (Transparent Reporting of Evaluations with Nonrandomized Designs) Statement Checklist was followed in reporting the study results. Application of the structured skin care protocol reduced the incidence of IAD from 35.9% in the control phase to 17.7% in the intervention phase (χ2 = 6.117, P < .05) and also decreased the severity of IAD (z = -2.023, P < .05). Further, IAD developed later (z = -2.116, P < .05) in the intervention group than in the control group. In addition, the nursing times to prevent or manage IAD did not differ significantly between the groups (t = -0.258, P > .05; t = -1.190, P > .05). Use of the developed structured skin care protocol for IAD in critically ill patients lowered the incidence and severity of IAD and delayed IAD development.

COMFORT communication in the ICU: Pilot test of a nurse-led communication intervention for surrogates.

This study was designed to investigate the feasibility, acceptability, and preliminary efficacy of a nurse-led communication intervention among surrogates in the intensive care unit (ICU) guided by the COMFORT (Connect; Options; Making meaning; Family caregivers; Openings; Relating; Team) communication model. As frontline communicators, nurses experience communication difficulties with surrogates who face complex informational and emotional barriers when making decisions for critically ill patients in the ICU. However, research on effective nurse communication focusing on both curative and end-of-life (EOL) care is lacking in the literature. A single-centre two-group pretest-posttest quasi-experiment. The total sample included 41surrogates of adult ventilated patients. Twenty participants were allocated to the intervention group who received a daily 20-min telephone call with content based on the COMFORT communication model. Twenty-one participants comprised the control group who received usual care. Participants completed a questionnaire before and after the study measuring satisfaction, anxiety and depression, decisional conflict, and quality of communication. The Transparent Reporting of Evaluations with Nonrandomized Designs (TREND) checklist was followed for nonrandomised controlled trials. The intervention was feasible, with 19 of 20surrogates completing the follow-up surveys, and 48 telephone conversations completed (48% of the planned phone calls). Surrogates' satisfaction was higher in the intervention group than in the control group after adjusting for the selected covariates (25.43 and 24.15, respectively; p=.512). Preliminary efficacy outcomes favouring the intervention included quality of communication with healthcare providers, but not surrogates' perceived depression/anxiety and decisional conflicts. Implementation of the intervention is feasible, acceptable, and favourable among surrogates to improve quality of communication with healthcare providers in the ICU. Further research is needed to determine whether the intervention could be implemented by nurses to improve surrogates' outcomes in other ICUs.

Effect of an evidence-based poster on the knowledge of delirium and its prevention in student nurses: A quasi-experimental study

Background A major barrier to nurses adopting evidence-based practice (EBP) has been the limited awareness of evidence underpinning clinical practice, often due to poor access and understanding of the literature base. To address this, we piloted the development of educational posters summarizing the evidence base around clinical practices to see if they help nurses better understand the rationale behind their care. Our first poster focused on the evidence supporting the management of delirium in older persons, specifically delirium identification and its prevention. Objective To examine the effect of an evidence-based poster education on the delirium knowledge of student nurses. Design A prospective two-armed quasi-experimental study. Methods 188 student nurses were recruited in December 2017. Participants were alternated to receive either an evidence-based poster education session or a reflective education session as a control. Both groups were assessed on their general knowledge on delirium, knowledge on delirium detection and knowledge on delirium prevention. This was conducted both before exposure to either the intervention or control, and one week after exposure. Unpaired t-tests with 95% confidence intervals (CI) were applied to compare the mean change in pre-test and post-test delirium knowledge. We used the Transparent Reporting of Evaluations with Nonrandomized Designs (TREND) checklist to report our methods and findings. Results Students in the poster education group reported greater improvements in mean scores of delirium identification (Mean increase = 1.0, p = 0.007, 95% CI: 0.3-1.6), delirium prevention (Mean increase = 1.6, p < 0.001, 9% CI: 1.0-2.2) and overall delirium knowledge (Mean increase = 2.7, p < 0.001, 95% CI: 1.5-3.8) than students in the control. Conclusion Summarised research evidence within a poster format can increase student nurses’ access to the evidence base. This has shown to increase their knowledge to guide their clinical practice. Impact statement Exposure to poster summaries of research evidence underpinning delirium care increases student nurses’ clinical knowledge of delirium identification and prevention.

Effectiveness of a musical fitness programme for older adults with cognitive impairment in long-term care facilities: A quasi-experimental study.

To investigate the effectiveness of a musical fitness programme (MFP) intervention in improving neuropsychiatric symptoms, depression, upper-limb muscle strength and cognition of older adults with cognitive impairment in long-term care (LTC) facilities. Because of population ageing, the number of older adults with cognitive impairment has been increasing. The effectiveness of medications in treating cognitive impairment is limited; therefore, the global trend has been for non-pharmacological treatments. However, intervention studies of MFPs on older LTC residents with cognitive impairment are scant. This study adopted a quasi-experimental design in accordance with the Transparent Reporting of Evaluations with Nonrandomized Designs (TREND) checklist. In total, 84 older adults with cognitive impairment were recruited from seven LTC facilities. The MFP was implemented from July-November 2019. The intervention group received the MFP, which was 50min per session, twice a week for 12weeks, whereas the comparison group received usual care. Neuropsychiatric inventory nursing home version, the Cornell scale for depression in dementia Chinese version, 30-s arm curl test and Mini-Mental State Examination were the outcome measures. Data were analysed using Chi-square test, t test and repeated measure analysis of variance. After the intervention, the scores of neuropsychiatric inventory and the Cornell depression exhibited significant differences over time between two groups (F=3.6, p=.029; F=5.96, p=.003, respectively). Nevertheless, 30-s arm curl test and Mini-Mental State Examination demonstrated non-significant between-group differences. The MFP can effectively reduce neuropsychiatric symptoms and depression in older adults with cognitive impairment in LTC facilities. To ensure a more robust evidence base, more research is warranted. The MFP is a non-pharmacological treatment that can be implemented to promote psychological well-being among older adults with cognitive impairment in LTC facilities, and to indirectly reduce nursing staff burden. To assist nursing staff in providing this intervention, on-the-job training is needed.

The Effect of Whole-Body Vibration Training on Biomarkers and Health Beliefs of Prefrail Older Adults

Frailty poses a considerable risk to the performance of daily living activities, affecting the quality of life of older adults and increasing their risks of falling, disability, hospitalization, and mortality. Frailty is related to pathology with a state of negative energy balance, sarcopenia, diminished muscle strength, and low tolerance for exertion. Few intervention studies have been conducted on prefrail community-dwelling older adults. This study investigated the effects of whole-body vibration training on the biomarkers and health beliefs of prefrail community-dwelling older adults. We conducted a quasi-experimental research. Ninety participants were allocated to either an experimental or control group. This study followed the Transparent Reporting of Evaluations with Nonrandomized Designs (TREND) guidelines for quasi-experimental research design. The experimental group participated in a 12-week whole-body vibration training conducted three times per week, with 5-min continuous vibration at 12-Hz frequency and 3-mm amplitude each time. DVDs on resistance training and manuals were provided to the control group. The data were analysed through descriptive analysis, a chi-square test, an independent t test, a paired t test, and analysis of covariance. There were 42 people in the experimental group and 48 people in the control group. After the 12-week training and intervention, ANCOVA is used to analyze the experimental and control group’s results. Experimental results in 30s chair stand test (F = 98.85, p &lt; 0.05), open-eye stand on dominant foot test (F = 26.15, p &lt; 0.05), two–minute-step test (F = 25.89, p &lt; 0.05), left-leg bone mineral density (F = 14.71, p &lt; 0.05), barriers of perceived frailty (F = 39.81, p &lt; 0.05) and cues to action (F = 92.96, p &lt; 0.05) in health beliefs are statistically significant compared to the control group’s results. The 12-week whole-body vibration program employed in this study partly improved the biomarkers and health beliefs of prefrail community-dwelling older adults. We recommend whole-body vibration training as an exercise strategy, thereby improving community-dwelling older adults’ biomarkers and health beliefs.

Quality of life among frail older persons (65+ years) in nursing homes: A cross-sectional study.

AimTo assess the quality of life in frail older persons (65+ years) living in nursing homes and to examine differences between quality of life perceptions among different gender and age groups.DesignCross‐sectional.MethodsData were collected during 2015‐2017 based on two questionnaires (WHOQOL‐OLD and WHOQOL‐BREF). Seventy‐eight older persons living in nursing homes in southern Sweden answered the questionnaires in structured interviews. Descriptive and comparative statistics were used to analyse the data. The study was guided by Transparent Reporting of Evaluations with Nonrandomized Designs (TREND) guidelines.ResultsThe frail older persons reported low autonomy related to few opportunities to engage in everyday activities and were unable to do the things they liked to do and not feeling in control of their future. Another important result was that frail older persons seemed to have no or little fear of death and dying. No significant differences between gender or age on quality of life were revealed.

Idiographic analyses of motivation and related processes in participants with schizophrenia following a therapeutic intervention for negative symptoms

BackgroundMotivational negative symptoms hinder quality of life and daily functioning of individuals with schizophrenia spectrum disorders. A recently developed intervention, Switch, has shown promising effects on negative symptoms and functional outcomes. Switch targets multiple cognitive, emotional and behavioural processes associated with motivation and goal directed behaviours. We aimed to investigate its effects on motivation and associated processes in a naturalistic setting, and to explore the dynamics between the processes.MethodsWe used a single case approach (n = 3), with a pre-post and follow-up assessment design, which also included ambulatory assessments (experience sampling method, ESM; and step count). We computed autoregressive lag 1 models to evaluate the effects of the intervention on daily motivation levels and related processes, descriptive pie-charts, and vector autoregressive modelling to reveal the dynamics of the processes over time.ResultsThe intervention was beneficial for each participant according to traditional evaluations of motivational negative symptoms, apathy, daily functioning and quality of life. The effects on the ESM variables revealed distinct outcomes for each individual. The dynamics between the various processes differed between participants, and fluctuated within participants (when comparing baseline, intervention phase, and follow-up).ConclusionsThis study used an innovative approach to look at the effectiveness of an intervention. The intervention seems to lead to meaningful improvements in motivational negative symptoms and functional outcomes. The mechanisms of change need to be further investigated.Trial registration numberClinicalTrials.gov, NCT04325100. Registered 27 March 27, 2020 -retrospectively registered.ReportingGuidelines from the Transparent Reporting of Evaluations with Non-randomized Designs (TREND) statement were followed.

Effectiveness of acupoint pressure on older people with constipation in nursing homes: a double-blind quasi-experimental study

Aims: To compare the differences between acupoint pressure, abdominal massage and laxatives in treatment of constipation for residents in two nursing homes. Background: There is lack of evidence on the utility of complementary therapies in the management of constipation among older adults. Design: Quasi-experimental. Methods: A total of 90 participants from two nursing homes in Taiwan were assigned to three groups: the control group (with laxatives only), group I (with laxatives and abdominal massage) and group II (with laxatives, acupoint pressure therapy [APT] and abdominal massage). The intervention was performed over 10 days. A double-blind technique was applied in both participants and the outcome assessors. Constipation as main outcome was evaluated and recorded for 10 days. Observation of the frequency of defecation and the consistency, particularly firmness of faeces over each 24 h’ period was recorded. The Transparent Reporting of Evaluations with Nonrandomized Designs (TREND) checklist was utilised in reporting methods and findings. Results: Three variations were revealed as interface factors and showed significant differences in each group. The results showed a statistically significant decrease in constipation in the experimental groups I and II. The scores of defecation frequency, difficulty degree and time of defecation, stool quality and awareness of defecation were obviously improved after treatment. Conclusions: We concluded APT could be used in conjunction with laxatives and must be considered as a long-term intervention. The combination of APT, abdominal massage and laxatives is superior to both abdominal massage with laxatives and laxatives alone. Relevance to clinical practice: Acupoint pressure as an effective complementary therapy of constipation among older adults living in nursing home provides a non-pharmacological, independent nursing intervention that nurses could use. This is relevant to nursing home settings where nurses make autonomous decision on important clinical assessments and interventions.

Efficacy of the Closed Suction Applied To Patients In Intensive Care Units with Different Techniques: A Nonrandomized Controlled Trial

Objective: The present study was conducted to investigate the effects of the closed suction system and different suction techniques in which oxygen and saline instillation were administered individually or in combination on the efficacy of suction, cardiopulmonary indicators, feelings and pain experienced by patients after suction. Method: This study was planned as an experimental and cross-sectional one. The study had a single group, and a pre- and post-test design (n=43). This study was planned as a single blind in line with the Transparent Reporting of Evaluations with Nonrandomized Designs (TREND). The study data were collected using the Data Collection Form aiming to assess hemodynamics, cardiopulmonary indicators and comfort and the Visual Analog Scale for Pain to assess pain. Parameters were measured before, during and at the 1st,3rd,5th,7th and 10th minutes after suction using different techniques, and the patients were asked how they felt during the suction. Although the processes were implemented by the researcher, data were recorded not by the researcher but by the other two nurses who voluntarily worked at the clinic. Results: It was found that the standard suction technique could be better tolerated. The administration of oxygen and saline instillation before suction individually or in combination caused anxiety in patients and affected study parameters statistically significantly. Conclusions: There was a statistically significant difference between aspiration with SI and other aspiration methods, but this difference was still within normal limits. The patients drew attention to relaxation after suction despite the discomfort they experienced during suction, it can be said that tracheal suction has a vital importance in ensuring the maintenance of airway patency and oxygenation, even though it is a discomforting and painful procedure.

How to start and develop a multicenter, prospective, randomized, controlled trial

Our main goal is to describe how to start and develop a multicenter, prospective, randomized, controlled trial.The first step is to have an idea that will become the hypothesis and a main objective. A bibliographic search should be done to check for clinical interest and originality. Moreover, the study must be feasible and should be finished within 4 years.In order to start the multicenter study, a protocol should be written (in accordance with the SPIRIT guidelines Standard Protocol items: Recommendations for Interventional Trials), including the design type, sample size and participating hospitals. Randomization is key to the design and, therefore, the CONSORT (Consolidated Standards of Reporting Trials) guidelines must be followed. However, if the study cannot be randomized, the TREND (Transparent Reporting of Evaluations with Non-Randomized Designs) guidelines are recommended.When the protocol is approved by the Ethics Committee for Clinical Investigation of the hospital, we ought to create visibility. It is suggested to register the trial on ClincalTrials.gov and submit its publication to indexed magazines.Financial resources are necessary to execute the study and maintain an online database. This allows the registry to be updated and accessible to all the participants in the study. What is more, randomization can be done immediately.And last, but not least, is motivation. Multicentricity equals to participation of all the chosen medical centers. Updating and motivating them by sending a newsletter every 1–3 months keeps participants engaged in the study.

Cómo poner en marcha y desarrollar un estudio multicéntrico prospectivo, controlado y aleatorizado

Our main goal is to describe how to start and develop a multicenter, prospective, randomized, controlled trial.The first step is to have an idea that will become the hypothesis and a main objective. A bibliographic search should be done to check for clinical interest and originality. Moreover, the study must be feasible and should be finished within 4 years.In order to start the multicenter study, a protocol should be written (in accordance with the SPIRIT guidelines Standard Protocol items: Recommendations for Interventional Trials), including the design type, sample size and participating hospitals. Randomization is key to the design and, therefore, the CONSORT (Consolidated Standards of Reporting Trials) guidelines must be followed. However, if the study cannot be randomized, the TREND (Transparent Reporting of Evaluations with Non-Randomized Designs) guidelines are recommended.When the protocol is approved by the Ethics Committee for Clinical Investigation of the hospital, we ought to create visibility. It is suggested to register the trial on ClincalTrials.gov and submit its publication to indexed magazines.Financial resources are necessary to execute the study and maintain an online database. This allows the registry to be updated and accessible to all the participants in the study. What is more, randomization can be done immediately.And last, but not least, is motivation. Multicentricity equals to participation of all the chosen medical centers. Updating and motivating them by sending a newsletter every 1-3 months keeps participants engaged in the study.

A Systematic Review of the Safety and Efficacy of Ayurveda Interventions for Hepatitis

Introduction: A systematic review is planned to investigate the safety and efficacy of Ayurveda interventions for hepatitis through analyzing published clinical research work. Materials and methods: We shall conduct a systematic review published clinical work for Ayurveda interventions for hepatitis. Electronic search of following databases will be performed: PubMed, AYUSH Research Portal, Digital Helpline for Ayurveda Research Articles (DHARA), Google Scholar, the Cochrane Library (the Cochrane Database of Systematic Reviews, the Cochrane Central Register of Controlled Trials (CENTRAL), and the Cochrane Methodology Register) without any restriction of publication year. Hand search, snowballing of studies will also be performed to fetch complete available literature. The selection of the studies, data abstraction, and validations will be performed independently by two teams of researchers. A conclusion will be derived from the consensus of the complete review team. Study selection will follow the preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines and study quality will be assessed by the CONSORT checklist for randomized controlled trials (RCTs), transparent reporting of evaluations with nonrandomized designs (TREND) checklist for nonrandomized controlled trials (NRCTs), and CONSORT extension for pilot and feasibility studies for pilot studies. Risk of bias assessment will be performed with the help of the Cochrane risk-of-bias tool for randomized trials (RoB2) tool for RCTs and risk of bias in nonrandomised studies of interventions (ROBINS-I) tool for NRCTs. If sufficient and appropriate data are available, a meta-analysis will be conducted. Subgroup analysis and sensitivity analysis will be performed if found to be necessary and feasible. Dissemination: The systematic review will be published in a peer-reviewed journal. The review will also be disseminated electronically and in print. The review will be updated to inform and guide healthcare practice and policy. Trial registration number: PROSPERO 2019: CRD42019103115.

Efficacy of Ayurvedic Interventions in Rheumatoid Arthritis

Introduction: Rheumatoid arthritis (RA) has been treated in Ayurveda, and substantial work has been done in studying the role of Ayurveda interventions in its management. A systematic review is planned to investigate the safety and efficacy of Ayurveda interventions for RA through analyzing published clinical research work. Materials and methods: This study is intended to systematically review the existing published clinical work including randomized controlled trials (RCTs), controlled clinical trials, parallel-group trials, and single-group clinical studies for Ayurveda interventions for RA. Electronic search of the following databases will be performed: PubMed, AYUSH research portal, digital helpline for Ayurveda research articles (DHARA), Google Scholar, the Cochrane Library (the Cochrane Database of systematic reviews, the Cochrane Central Register of Controlled Trials (CENTRAL), and the Cochrane Methodology Register), Ayurveda college/Universities websites, databases for dissertation works without any restriction of publication year. Hand search and snowballing of studies will also be performed to fetch complete available literature. The selection of the studies, data abstraction, and validations will be performed independently by two teams of researchers. Conclusion will be derived with consensus of complete review team. Study selection will follow the preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines, and study quality will be assessed by CONSORT checklist for RCTs, Transparent Reporting of Evaluations with Nonrandomized Designs (TREND) checklist for nonrandomized controlled trial (NRCTs), and CONSORT extension for Pilot and feasibility studies for pilot studies. Risk of bias assessment will be performed with the help of Cochrane RoB2 tool for RCTs and Risk of Bias in Non-randomized Studies of Interventions (ROBINS-I) tool for NRCTs. If sufficient and appropriate data are available, a meta-analysis will be conducted. Subgroup and sensitivity analyses will be performed if found to be necessary and feasible. Ethics and dissemination: Formal ethical approval is not required as primary data will not be collected. The results will be disseminated through a peer-reviewed publication. The review will be updated to inform and guide healthcare practice and policy. Trial Registration Number: International Prospective Register for Systematic Reviews (PROSPERO) number 2019 CRD42019133722.

The impact of the tax on sweetened beverages: a systematic review

Obesity has a serious impact on public health. Sugar-sweetened beverages (SSBs) are implicated in the obesity epidemic. Regulation has been suggested as one approach to limit consumption. The aim of this study was to synthesize existing evidence related to the impact of taxes on the consumption, purchase, or sales of SSBs. A systematic review was conducted by using MEDLINE through PubMed (https://www.ncbi.nlm.nih.gov/pubmed), the Cochrane Library (http://www.cochranelibrary.com/), the Web of Science (https://login.webofknowledge.com/error/Error?PathInfo=%2F&Error=IPError), and Scopus (https://www.scopus.com/search/form.uri?display=basic) in the period 2011-2017 for studies that analyzed the impact of fiscal regulatory measures on the consumption, purchase, or sales of SSBs. The quality of evidence was assessed according to the CONSORT (Consolidated Standards of Reporting Trials) and the TREND (Transparent Reporting of Evaluations with Nonrandomized Designs) statements. Of the 17 studies, 5 (29.4%) evaluated the impact of a tax on SSBs in naturalistic experiments by county or city in the United States and in Mexico. Findings indicated that purchases or sales of SSBs decreased significantly with taxation amounts of 8% (Berkeley, CA) and 10% (Mexico). One study found no effect on sales of SSBs in 2 states that enacted a 5.5% tax on sodas. Twelve (70.6%) studies were based on virtual or experimental conditions evaluating either purchasing behavior or sales (6 studies; 50.0%) or behavioral intent (6 studies; 50.0%), resulting in a decrease in either purchasing behavior or sales or intent behavior with heterogeneity according to the tax rate. Taxation significantly influences planned purchases and increases the probability of the purchase of healthy beverages. SSB taxes have the potential to reduce calorie and sugar intake, but further research is needed to evaluate effects on diet quality.

Effectiveness of a 16 week gymnastics curriculum at developing movement competence in children

Internationally, children's movement competence levels are low. This study's aim was to evaluate the effectiveness of a 16 week gymnastics curriculum on stability, locomotive and object control skills and general body coordination. It was hypothesised that the gymnastics intervention group would demonstrate significant improvements beyond a PE comparison group. This study used a non-randomised control design. The intervention and comparison groups were drawn from three primary schools. The study followed the transparent reporting of evaluations with nonrandomized designs (TREND) statement for reporting. A total of 333 children (51% girls, 41% intervention) with a mean age of 8.1 years (SD=1.1) participated. Intervention children (16 weeks×2h of gymnastics) were compared to children who received (16×2h) standard PE curriculum. Children's movement competence was assessed using the Test of Gross Motor Development-2, Stability Skills Assessment and the Körper-Koordinationstest für Kinder. Multilevel linear mixed models, accounting for variation at the class level and adjusted for age and sex, were used to assess intervention relative to comparison differences in all aspects of movement competence. Stability and object control skills showed a significant (p<0.05) intervention×time interaction effect. No difference was found in locomotor skills or general coordination. Gymnastics is effective at developing stability skills and object control skills without hindering the development of locomotor skills or general coordination. Accelerated learning of stability skills may support the development of more complex movement skills.

Comparative Analysis of External Validity Reporting in Non-randomized Intervention Studies.

This article describes a comparative analysis of external validity reporting in non-randomized behavioural and public health intervention studies that used and did not use the TREND (Transparent Reporting of Evaluations with Non-randomized Designs) statement. The search resulted in 14 non-randomized intervention studies that were rated based on Green and Glasgow's criteria for external validity reporting. Studies that used the TREND statement demonstrated improved external validity reporting when compared with studies that did not use the TREND statement. The implication is that the TREND statement and Green and Glasgow's criteria can improve external validity reporting of non-randomized behavioural and public health interventions.

Impact of the transparent reporting of evaluations with nonrandomized designs reporting guideline: ten years on.

We assessed how the Transparent Reporting of Evaluations with Nonrandomized Designs (TREND) reporting guideline was used by authors and journal editors in journals' instructions to authors. We also evaluated its impact on reporting completeness and study quality. We extracted data from publications that cited TREND on how TREND was used in those reports; we also extracted information on journals' instructions to authors. We then undertook a case-control study of relevant publications to evaluate the impact of using TREND. Between 2004 and 2013, TREND was cited 412 times, but it was only evidently applied to study reports 47 times. TREND was specifically mentioned 14 times in the sample of 61 instructions to authors. Some evidence suggested that use of TREND was associated with more comprehensive reporting and higher study quality ratings. TREND appeared to be underutilized by authors and journal editors despite its potential application and benefits. We found evidence that suggested that using TREND could contribute to more transparent and complete study reports. Even when authors reported using TREND, reporting completeness was still suboptimal.

A systematic scoping review of adherence to reporting guidelines in health care literature

BackgroundReporting guidelines have been available for the past 17 years since the inception of the Consolidated Standards of Reporting Trials statement in 1996. These guidelines were developed to improve the quality of reporting of studies in medical literature. Despite the widespread availability of these guidelines, the quality of reporting of medical literature remained suboptimal. In this study, we assess the current adherence practice to reporting guidelines; determine key factors associated with better adherence to these guidelines; and provide recommendations to enhance adherence to reporting guidelines for future studies.MethodsWe undertook a systematic scoping review of systematic reviews of adherence to reporting guidelines across different clinical areas and study designs. We searched four electronic databases (Cumulative Index to Nursing and Allied Health Literature, Web of Science, Embase, and Medline) from January 1996 to September 2012. Studies were included if they addressed adherence to one of the following guidelines: Consolidated Standards of Reporting Trials (CONSORT), Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), Quality of Reporting of Meta-analysis (QUOROM), Transparent Reporting of Evaluations with Nonrandomized Designs (TREND), Meta-analysis Of Observational Studies in Epidemiology (MOOSE) and Strengthening the Reporting of Observational Studies in Epidemiology (STROBE). A protocol for this study was devised. A literature search, data extraction, and quality assessment were performed independently by two authors in duplicate. This study reporting follows the PRISMA guidelines.ResultsOur search retrieved 5159 titles, of which 50 were eligible. Overall, 86.0% of studies reported suboptimal levels of adherence to reporting guidelines. Factors associated with better adherence included journal impact factor and endorsement of guidelines, publication date, funding source, multisite studies, pharmacological interventions and larger studies.ConclusionReporting guidelines in the clinical literature are important to improve the standards of reporting of clinical studies; however, adherence to these guidelines remains suboptimal. Action is therefore needed to enhance the adherence to these standards. Strategies to enhance adherence include journal editorial policies endorsing these guidelines.

Methods reporting in human laboratory studies

There is growing concern in the behavioural and biomedical sciences regarding the replicability of much published research 1, 2. In response to this, initiatives such as the Reproducibility Project are emerging. This project is attempting the replication of findings reported in three major psychology journals in 2008, with the hope of improving understanding of the rate and predictors of replication 3. However, for replication to be possible, accurate and complete reporting of scientific methods is essential. To ensure this, a number of journals now require authors to use checklists prior to manuscript submission. The Consolidated Standards of Reporting Trials (CONSORT) checklist 4 was created in the early 1990s through a realization that the reporting of randomized controlled trials was suboptimal. Similar checklists are now commonplace for reporting meta-analyses and systematic reviews [Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)] 5, observational studies in epidemiology [STrengthening the Reporting of OBservational studies in Epidemiology (STROBE)] 6, evaluations with non-randomized designs [Transparent Reporting of Evaluations with Nonrandomized Designs (TREND)] 7 and in-vivo animal studies [Animal Research: Reporting In Vivo Experiments (ARRIVE)] 8. These checklists assist in both the reporting of the work and in replicating it, by ensuring that all the necessary information is available. A recent paper, published in Addiction 9, drew our attention to the need for a similar checklist when reporting human laboratory studies. In the paper, a visual probe task was used to investigate visual attention to cigarette package health warnings, with and without text-captions. Health warnings and neutral stimuli were presented simultaneously on either side of a screen, followed by a probe replacing the position occupied previously by one of the stimuli. Participants pressed one of two buttons as quickly as possible in response to the probe location. Faster reaction times to respond to probes replacing health warnings with text-captions among smokers were taken to represent an attentional bias to these stimuli. However, this conclusion can be made only when presentation times of visual stimuli are short, allowing time for a single orientating eye movement. Longer presentation times make results difficult to interpret as multiple eye movements are possible, allowing the disengagement of attention as well as refixations before probe onset. Knowing the presentation time of stimuli in this task is therefore vital. However, this detail was unreported in this paper, rendering the results impossible to interpret for the reader and the study impossible to replicate without contacting the authors for further information. Oversights and omissions such as these are not uncommon in scientific reporting, and noticing them should not be the sole responsibility of authors, but of reviewers and journal editors as well. While we recognize that human laboratory studies are extremely diverse, and creating a one-size-fits-all checklist might be complex, this is something that should be considered seriously. Nature Neuroscience has recently announced the introduction of its own methods reporting checklist 10, to be completed by authors prior to submission, describing the study design, procedure, data analysis and results in detail. Preliminary data indicate that reviewers using the checklist described their methods and statistics more thoroughly than reviewers not using the checklist. We feel that a similar model at Addiction would pave the way for more transparent, accurate and easily replicable studies. None.