Search

Background: The benefits of comprehensive geriatric assessment (CGA) are well established for hospital care but less so for primary care. Our primary objective was to assess the effect of two multifaceted interventions based on a CGA adapted for primary care on a composite criterion combining all-cause mortality, emergency department visits, unplanned hospital admissions, and institutionalisation. Methods: This open-label, pragmatic, three-arm, cluster-randomised controlled trial involved 39 general practices in France. It included 634 patients aged 70 years or over with chronic health conditions and/or an unplanned hospital admission in the past 3 months, between 05/2016 and 08/2018. Interventions were in arm 1: a systematic nurse-led CGA; arm 2: a GP-led CGA, at the GP's discretion; arm 3: standard care. The primary composite endpoint was assessed at 12 months. The secondary endpoints included: components of the composite endpoint, health-related quality of life (Duke Health Profile), functional status (Katz Activities of Daily Living Index) and medications (number) at 12 months. Pairwise comparisons between the experimental groups and the control were tested. The main analysis was performed on the intention-to-treat (ITT) population, after imputing missing information and adjusting for baseline imbalances by mixed effects regressions. Results: For the primary composite outcome, no statistically significant difference was found between arm 1 and the control (adjusted odds ratio [aOR] = 0.81 [95%CI 0.54–1.21], P = 0.31), whereas arm 2 and the control differed significantly (aOR = 0.60 [0.39–0.93], P = 0.022). A statistically lower risk of unplanned hospital admission in arm 2 vs control (aOR = 0.57 [0.36–0.92], P = 0.020)) was observed, while no statistically significant differences were found for the other components and between arm 1 and the control. None of the other secondary endpoints differed between arms. Conclusions: Our study led in community-dwelling older patients with chronic conditions found no significant effect of a CGA adapted for primary care on mortality, functional independence and quality of life, but suggests that a GP-led CGA may reduce the risk of unplanned hospital admission. Our study demonstrates the feasibility of incorporating CGA into clinical practice and highlights its potential benefits when applied on a case-by-case basis, guided by the GPs who develop the resulting PCP. Trial registration: NCT02664454. [ABSTRACT FROM AUTHOR]

Abstract Background The benefits of comprehensive geriatric assessment (CGA) are well established for hospital care but less so for primary care. Our primary objective was to assess the effect of two multifaceted interventions based on a CGA adapted for primary care on a composite criterion combining all-cause mortality, emergency department visits, unplanned hospital admissions, and institutionalisation. Methods This open-label, pragmatic, three-arm, cluster-randomised controlled trial involved 39 general practices in France. It included 634 patients aged 70 years or over with chronic health conditions and/or an unplanned hospital admission in the past 3 months, between 05/2016 and 08/2018. Interventions were in arm 1: a systematic nurse-led CGA; arm 2: a GP-led CGA, at the GP’s discretion; arm 3: standard care. The primary composite endpoint was assessed at 12 months. The secondary endpoints included: components of the composite endpoint, health-related quality of life (Duke Health Profile), functional status (Katz Activities of Daily Living Index) and medications (number) at 12 months. Pairwise comparisons between the experimental groups and the control were tested. The main analysis was performed on the intention-to-treat (ITT) population, after imputing missing information and adjusting for baseline imbalances by mixed effects regressions. Results For the primary composite outcome, no statistically significant difference was found between arm 1 and the control (adjusted odds ratio [aOR] = 0.81 [95%CI 0.54–1.21], P = 0.31), whereas arm 2 and the control differed significantly (aOR = 0.60 [0.39–0.93], P = 0.022). A statistically lower risk of unplanned hospital admission in arm 2 vs control (aOR = 0.57 [0.36–0.92], P = 0.020)) was observed, while no statistically significant differences were found for the other components and between arm 1 and the control. None of the other secondary endpoints differed between arms. Conclusions Our study led in community-dwelling older patients with chronic conditions found no significant effect of a CGA adapted for primary care on mortality, functional independence and quality of life, but suggests that a GP-led CGA may reduce the risk of unplanned hospital admission. Our study demonstrates the feasibility of incorporating CGA into clinical practice and highlights its potential benefits when applied on a case-by-case basis, guided by the GPs who develop the resulting PCP. Trial registration NCT02664454.

Background This study examines integrating physical and mental healthcare for disadvantaged persons with type 2 diabetes mellitus and mild-to-moderate depression in the community, using a mobile application within a public-private-academic partnership. Methods The Korean Diabetes Association has developed a mobile application combining behavioral activation for psychological well-being and diabetes self-management, with conventional medical therapy. Participants were randomly assigned to receive the application with usual care or only usual care. Primary outcomes measured changes in psychological status and diabetes self-management through questionnaires at week 12 from the baseline. Secondary outcomes assessed glycemic and lipid control, with psychological assessments at week 16. Results Thirty-nine of 73 participants completed the study (20 and 19 in the intervention and control groups, respectively) and were included in the analysis. At week 12, the intervention group showed significant reductions in depression severity and perceived stress compared to the control group. Additionally, they reported increased perceived social support and demonstrated improved diabetes self-care behavior. These positive effects persisted through week 16, with the added benefit of reduced anxiety. While fasting glucose levels in the intervention group tended to improve, no other significant differences were observed in laboratory assessments between the groups. Conclusion This study provides compelling evidence for the potential efficacy of a mobile application that integrates physical and mental health components to address depressive symptoms and enhance diabetes self-management in disadvantaged individuals with type 2 diabetes mellitus and depression. Further research involving larger and more diverse populations is warranted to validate these findings and solidify their implications.

Parkinson's disease (PD) is a chronic and complex neurodegenerative disorder. Conventional pharmacological or surgical therapies alone are often insufficient at adequately alleviating disability. Moreover, there is an increasing shift toward person-centered care, emphasizing the concept of "living well". In this context, arts-based interventions offer great promise, functioning as platforms for creative expression that could provide novel mechanisms to promote quality of life. Here we present a qualitative review of arts-based interventions for PD, including music, dance, drama, visual arts, and creative writing. For each, we discuss their applications to PD, proposed mechanisms, evidence from prior studies, and upcoming research. We also provide examples of community-based projects. Studies to date have had relatively small sample sizes, but their findings suggest that arts-based interventions have the potential to reduce motor and non-motor symptoms. They may also empower people with PD and thereby address issues of self-esteem, foster personal problem-solving, and augment holistic well-being. However, there is a paucity of research determining optimal dosage and symptom-specific benefits of these therapies. If art were a drug, we would have to perform appropriately powered studies to provide these data before incorporating it into routine patient care. We therefore call for further research with properly designed studies to offer more rigorous and evidence-based support for what we intuitively think is a highly promising approach to support individuals living with PD. Given the possible positive impact on people's lives, arts-based approaches merit further development and, if proven to be effective, systematic inclusion within integrated management plans. [ABSTRACT FROM AUTHOR]

Background: Various treatment modalities have been employed for mechanical low back pain (MLBP), but evidence of their efficacy varies greatly. Objectıve: This randomized controlled trial aimed to assess the outcomes of Mulligan concept applications, including sustained natural apophyseal glides (SNAGS) and natural apophyseal glides (NAGS), in obese patients with MLBP. Methods: The study, conducted between January 2021 and June 2022 at a tertiary hospital, involved randomizing patients into two groups. Both groups underwent six sessions of stretching and strengthening exercises every other day. The Mulligan group received additional intervention with SNAG and NAGS techniques. Measurements were made regarding the Visual Analog Scale (VAS) score, Oswestry Disability Index (ODI) score and range of motion (ROM) for the patients' MLBP level. Results: Post-interventions, both groups exhibited positive changes in flexion ROM, extension ROM, right and left rotation ROM, right and left lateral flexion ROM, VAS score, and ODI score compared to pre-intervention (p < 0.001 for both groups and variables). The Mulligan group showed a higher increase in ROM and a more significant decrease in VAS and ODI scores. Conclusıons: Mulligan mobilization techniques prove significantly beneficial for enhancing ROM in all directions, reducing pain levels, and alleviating disability in obese individuals with MLBP. [ABSTRACT FROM AUTHOR]

BACKGROUND: Elastic taping that applies shear force affects joint movement. However, it remains uncertain whether elastic taping or stretching is more effective in improving flexibility. OBJECTIVE: We investigated whether elastic taping for flexibility improvement is comparable to traditional stretching. METHODS: In this randomized controlled trial, 64 university students were randomly allocated to two groups: elastic taping on the sole or 30 s of static stretching. The primary outcome measures were the straight leg raising angle, tested with an equivalence margin (± 9.61∘ on changes), and the fingertip-to-floor distance. Secondary outcomes were the hip flexor and knee extensor strength, two-step distance, adverse events, and pain intensity during the intervention, which were compared using conventional statistical methods. RESULTS: The mean differences in straight leg raising between the two groups after the interventions were not greater than the equivalence margin (mean [95% CI]: 1.4 [ - 6.9, 9.5]; equivalence margin, - 9.61∘ to 9.61∘). There were no consistent differences between groups in terms of secondary outcomes except for pain intensity during the intervention (p > 0.05). Elastic taping did not induce pain. CONCLUSION: Elastic taping augments the flexibility-improving effect comparable to static stretching, based on an equivalence margin. Elastic taping of the sole appears to be an alternative method of improving flexibility. [ABSTRACT FROM AUTHOR]

Background: Intervention fidelity is a critical element of randomized controlled trials, yet reporting of intervention fidelity among attention control arms is limited. Lack of fidelity to attention control procedures can affect study outcomes by either overestimating or underestimating the efficacy of the intervention under examination. Objectives: This brief report describes the approach researchers took to promote fidelity to the attention control arm of a pediatric palliative care randomized controlled trial funded by the National Institutes of Health. Methods: The Informational Meetings for Planning and Coordinating Treatment trial aims to determine the efficacy of a communication intervention that uses care team dyads (i.e., physicians partnered with nurses or advanced practice providers) to engage parents of children with cancer who have a poor prognosis in structured conversations about prognostic information, goals of care, and care planning. The intervention is compared with an attention control arm, which provides parents with structured conversations on common pediatric cancer education topics, such as talking to their child about their cancer, clinical trials, cancer treatment, side effects, and so forth. National Institutes of Health guidelines for assessing and implementing strategies to promote intervention fidelity were used to design (a) the attention control arm of a randomized controlled trial, (b) related attention control arm training, and (c) quality assurance monitoring. Results: Attention control study procedures were designed to mirror that of the intervention arm (i.e., same number, frequency, and time spent in study visits). Cluster randomization was used to allocate care team dyads to one arm of the randomized controlled trial. Care team dyads assigned to the attention control arm participated in online training sessions to learn attention control procedures, the different roles of research team members, and quality assurance methods. Fidelity to attention control procedures is assessed by both the interveners themselves and a quality assurance team. Discussion: Study design, training, and delivery are all critical to attention control fidelity. Baseline training often needs to be supplemented with booster training when time gaps occur between study start-up and implementation. Quality assurance procedures are essential to determine whether interveners consistently deliver attention control procedures correctly. [ABSTRACT FROM AUTHOR]

More than a decade after the Consolidated Standards of Reporting Trials group released a reporting items checklist for non-inferiority randomized controlled trials, the infectious diseases literature continues to underreport these items. Trialists, journals, and peer reviewers should redouble their efforts to ensure infectious diseases studies meet these minimum reporting standards. [ABSTRACT FROM AUTHOR]

Purpose: Harms are often overlooked, but important, outcomes of randomized controlled trial reporting. Our goal was to determine if harms reporting has improved in high-impact urology journals. Materials and Methods: Randomized controlled trials published in The Journal of UrologyÂ, Urology, European Urology, and BJU International in 2012 and 2020 were analyzed. Each randomized controlled trial was evaluated by 2 authors in a masked-duplicate fashion to evaluate for adherence to harms reporting guidelines recommended by the Consolidated Standards of Reporting Trials (CONSORT) group. Results: One hundred and thirty-two published studies met inclusion criteria. Between 2012 and 2020, there was a statistically significant increase in the median number of harms criteria reported between 2012 and 2020 (5.3 vs 7.2; P = .01). Methods criteria demonstrating the greatest improvements included item #3 "which harms were assessed," item #4a "when harm information was collected," and item#4b "methods to attribute harm to intervention." Results sections with the most improvement in reporting include item #6 "reasons for patient withdrawal," item #8a "effect size for harms," and item #8b "stratified serious D minor harms.". Conclusions: Reporting of adverse events in randomized trials published in several top urology journals has demonstrated marked improvement. Studies published in 2020 reported approximately 70% of CONSORT-Harms criteriadan increase of nearly 40% since 2004. While these improvements mark significant change, deficits remain present and should be addressed to provide clinicians with the most complete perspective possible. [ABSTRACT FROM AUTHOR]

ABSTRACT Objectives: To provide an overview of low-intensity extracorporeal shockwave therapy (LIEST) for erectile dysfunction (ED), pointing out which concepts are already consolidated and which paths we still need to advance. Materials and Methods: We performed a narrative review of the literature on the role of shockwave therapies in erectile dysfunction, selecting publications in PUBMED, including only relevant clinical trials, systematic reviews and meta-analyses. Results: We found 11 studies (7 clinical trials, 3 systematic review and 1 meta-analysis) that evaluated the use of LIEST for the treatment of erectile dysfunction. One clinical trial evaluated the applicability in Peyronie’s Disease and one other clinical trial evaluated the applicability after radical prostatectomy. Conclusions: The literature presents little scientific evidence but suggests good results with the use of LIEST for ED. Despite a real optimism since it is a treatment modality capable of acting on the pathophysiology of ED, we must remain cautious, until a larger volume of higher quality studies allows us to establish which patient profile, type of energy and application protocol will achieve clinically satisfactory results.

Background: Various treatment modalities have been employed for mechanical low back pain (MLBP), but evidence of their efficacy varies greatly. Objectıve: This randomized controlled trial aimed to assess the outcomes of Mulligan concept applications, including sustained natural apophyseal glides (SNAGS) and natural apophyseal glides (NAGS), in obese patients with MLBP. Methods: The study, conducted between January 2021 and June 2022 at a tertiary hospital, involved randomizing patients into two groups. Both groups underwent six sessions of stretching and strengthening exercises every other day. The Mulligan group received additional intervention with SNAG and NAGS techniques. Measurements were made regarding the Visual Analog Scale (VAS) score, Oswestry Disability Index (ODI) score and range of motion (ROM) for the patients’ MLBP level. Results: Post-interventions, both groups exhibited positive changes in flexion ROM, extension ROM, right and left rotation ROM, right and left lateral flexion ROM, VAS score, and ODI score compared to pre-intervention (p < 0.001 for both groups and variables). The Mulligan group showed a higher increase in ROM and a more significant decrease in VAS and ODI scores. Conclusıons: Mulligan mobilization techniques prove significantly beneficial for enhancing ROM in all directions, reducing pain levels, and alleviating disability in obese individuals with MLBP.

Objective: We wish to update existing meta-analyses to assess the effectiveness of pharmacological agents against ureteral stent-related symptoms with better design of RCTs, as well as more valid and reliable measurement methods. Material & Methods: Relevant published articles up to February 2022 were obtained from PubMed, CENTRAL, Google Scholar, Science Direct, and DOAJ. All single-blind or double-blind RCTs with various comparisons using pharmacological agents and/or placebo in patients with ureteral stent-related symptoms, with outcome assessment using USSQ at week 1 and week 4 during stent placement was included in the study. Statistical parameter Mean Difference (MD) with 95% CI was used to measure effect size. The p value less than 0.05 indicates statistical significance. Results: Alpha blockers (2 studies, 85 samples) significantly reduced fourth week UIS compared to placebo (MD: – 5.46, 95% CI: – 7.47 to -3.46, I2 = 0%, P = < 0.001), and alpha blockers (2 studies, 42 samples) significantly reduced first week SIS compared to combination therapy (MD: – 0.82, 95% CI: – 1.56 to – 0.08, I2 = 0%, P = 0.03). The results of the meta-analysis of USSQ scores in other domains have no significant differences. Conclusion: Alpha blockers were better than placebo in reducing UIS due to ureteral stent in the fourth week of stent placement, and better than combination therapy in reducing SIS due to ureteral stent in the first-week post stenting. However, more RCTs are needed with larger samples and better designs to reach valid conclusions. Keywords: Stents, Randomized Controlled Trials as Topic, Single-Blind Method.

BackgroundHypothermia is common and active warming is recommended in major surgery. The potential effect on hospitals and payer costs of aggressive warming to a core temperature target of 37°C is poorly understood.MethodsIn this sub-analysis of the PROTECT trial (clinicaltrials.gov, NCT03111875), we included patients who underwent radical procedures of colorectal cancer and were randomly assigned to aggressive warming or routine warming. Perioperative outcomes, operation room (OR) scheduling process, internal cost accounting data from the China Statistical yearbook (2022), and price lists of medical and health institutions in Beijing were examined. A discrete event simulation (DES) model was established to compare OR efficiency using aggressive warming or routine warming in 3 months. We report base-case net costs and sensitivity analyses of intraoperative aggressive warming compared with routine warming. Costs were calculated in 2022 using US dollars (USD).ResultsData from 309 patients were analyzed. The aggressive warming group comprised 161 patients and the routine warming group comprised 148 patients. Compared to routine warming, there were no differences in the incidence of postoperative complications and total hospitalization costs of patients with aggressive warming. The potential benefit of aggressive warming was in the reduced extubation time (7.96 ± 4.33 min vs. 10.33 ± 5.87 min, p

A time-to-first-event composite endpoint analysis has well-known shortcomings in evaluating a treatment effect in cardiovascular clinical trials. It does not fully describe the clinical benefit of therapy because the severity of the events, events repeated over time, and clinically relevant nonsurvival outcomes cannot be considered. The generalized pairwise comparisons (GPC) method adds flexibility in defining the primary endpoint by including any number and type of outcomes that best capture the clinical benefit of a therapy as compared with standard of care. Clinically important outcomes, including bleeding severity, number of interventions, and quality of life, can easily be integrated in a single analysis. The treatment effect in GPC can be expressed by the net treatment benefit, the success odds, or the win ratio. This review provides guidance on the use of GPC and the choice of treatment effect measures for the analysis and reporting of cardiovascular trials. [Display omitted] • GPC is a statistical method that overcomes shortcomings of time-to-first-event analyses. • GPC can assess treatment effects as NTB, SO, and WR. • This review provides guidance on the use of GPC and choice of treatment effect measures. [ABSTRACT FROM AUTHOR]

Copyright of Arquivos Brasileiros de Oftalmologia is the property of Arquivos Brasileiros de Oftalmologia and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

ABSTRACT Objectives: Describe the frequency and types of outcomes in randomized clinical trials (RCT) of intervention for distal radius fractures, analyze how confusing outcome presentations can lead to misinterpretations, and suggest strategies to improve the reader's understanding of the decision-making process. Methods: A retrospective study was conducted through a systematized search on the PubMed® database in the last 10 years, in which only intervention RCT was included for distal radius fractures, and outcomes were analyzed. Results: Of the primary outcomes analyzed in the 75 selected articles, 46.6% were classified as clinical outcomes, 20% as surrogate, 30.6% as composite, 1.3% as complex scales, and 1.3% as safety outcomes. 34.7% of the articles did not report adverse events. Conclusion: The presentation of outcomes with little clinical relevance represented more than half of the sample (53.4%) - such studies can harm the reader since they confuse the interpretation of scientific evidence; the Core Outcome Measures in Effectiveness Trials (COMET) initiative could help health professionals in understanding and selecting the most appropriate therapeutic interventions for patients. Level of Evidence III; Retrospective comparative study .

Purpose: "Spin" refers to a form of language manipulation that positively reflects negative findings or downplays potential harms. Spin has been reported in randomized controlled trials of other surgical specialties, which can lead to the recommendation of subpar or ineffective treatments. The goal of this study was to characterize spin strategies and severity in statistically nonsignificant urology randomized controlled trials. Materials and Methods: A comprehensive search of MEDLINE and Embase for the top 5 urology journals, major urology subspecialty journals, and high-impact nonurology journals from 2019 to 2021 was conducted. Statistically nonsignificant randomized controlled trials with a defined primary outcome were included. Screening, data extraction, and spin assessment were performed in duplicate by 2 independent reviewers. Results: From the database search of 4,339 studies, 46 trials were included for analysis. Spin was identified in 35 studies (76%), with the majority of abstracts (n = 26, 57%) and main texts (n = 35, 76%) containing some level of spin. "Obscuring the statistical nonsignificance of the primary outcome and focusing on statistically significant secondary results" was the most frequently used strategy in abstracts, while "other" strategies not previously defined were the most commonly used strategies in main texts. Moderate or high spin severity was identified in 21 (46%) abstract and 22 (48%) main text conclusions. Conclusions: Overall, our results suggest that 76% of statistically nonsignificant urology randomized controlled trials contained some level of spin. Readers and writers should be aware of common spin strategies when interpreting nonsignificant results and critically appraise the significance of results when making decisions for clinical practice. [ABSTRACT FROM AUTHOR]

Selective outcome reporting (SOR) is a type of bias that can compromise the validity of results and affect evidence-based practice. SOR can overestimate the effect of an intervention and lead to conclusions that a treatment is effective when it is not. This study aimed to investigate the prevalence of SOR in publications of RCTs on non-surgical periodontal therapy (NSPT) and to verify associated factors. The protocols were searched and selected on the www.clinicaltrials.gov platform up to January 16, 2022. Corresponding publications were identified, and data extraction and discrepancy analysis were performed. The risk of bias was assessed according to the RoB2 tool. One hundred forty-five studies (174 publications) were included. The prevalence of SOR was 49.7% and was unclear in nearly one third of studies (27.6%). Only 31.7% of the primary outcomes were completely described in the publications. The overall risk of bias was high in 60% of the included studies. SOR was associated with statistical significance (p < .001), and multiple publications of the same study (p = .005). Our study demonstrated the high prevalence of SOR, highlighting the need to improve the quality of reporting of RCTs on NSPT studies. [ABSTRACT FROM AUTHOR]

ABSTRACT BACKGROUND: Although the concept of an “ongoing study” seems self-explanatory, it is difficult to determine whether a trial is underway. OBJECTIVE: To analyze the definitions of “ongoing clinical trial” across different clinical trial registries, methodological guidelines, and other sources. DESIGN AND SETTING: This meta-research study was conducted at the Universidade Federal de São Paulo (UNIFESP), Brazil. METHODS: We performed a cross-sectional analysis of relevant clinical trial registry databases, methodological guidelines for conducting systematic reviews, and other sources that would define or regulate clinical trials. RESULTS: We identified various heterogeneous definitions used by eligible sources at both the start and end of a clinical trial. The starting criteria used were as follows: when the team is planning the protocol, when permission is given to conduct the study, or when the first participant is enrolled. Some sources used the time at which the last outcome data was collected as a criterion to determine the end of the trial. The International Committee of Medical Journal Editors stated that a study is still “ongoing” during the analysis process. Several sources use a vague definition or present no clear criteria for defining the start or end of a study. CONCLUSION: The concept of “ongoing clinical trials” lacks a transparent and homogeneous definition across relevant sources. A consensus on this concept is important to facilitate the evaluation of available evidence and conduct research synthesis. Further efforts are necessary to determine the best definition for the start and end of a clinical trial.

Background/Aims L-carnitine is potentially beneficial in patients with hepatic encephalopathy (HE). We aimed to evaluate the impact of L-carnitine on the quality of life and liver function in patients with liver cirrhosis and covert HE. Methods We conducted an investigator-initiated, prospective, multi-center, double-blind, randomized phase III trial in patients with covert HE. A total of 150 patients were randomized 1:1 to L-carnitine (2 g/day) or placebo for 24 weeks. Changes in quality of life and liver function were assessed at 6 months. The model for end-stage liver disease (MELD), the 36-Item Short Form Survey (SF-36), the psychometric hepatic encephalopathy score (PHES), and the Stroop Test were evaluated in all patients. Results The total SF-36 score significantly improved in the L-carnitine group after 24 weeks (difference: median, 2; interquartile range, 0 to 11; p < 0.001); however, these values were comparable between the two groups. Furthermore, there was a significant ordinal improvement in PHES scores among patients with minimal HE who were in the L-carnitine group (p = 0.007). Changes in the total carnitine level also positively correlated with improvements in the Stroop test in the L-carnitine group (color test, r = 0.3; word test, r = 0.4; inhibition test, r = 0.5; inhibition/switching test, r = 0.3; all p < 0.05). Nevertheless, the MELD scores at week 24 did not differ between the groups. Conclusions Twenty-four weeks of L-carnitine supplementation was safe but ineffective in improving quality of life and liver function.

The incidence of delirium in intensive care patients remains high, and its consequences have a high negative impact on patients, their families, health care teams, and society in general. Because delirium can lead to increased hospital stay, increased days on mechanical ventilation, increased risk of adverse events, increased memory loss and even increased mortality. However, some factors that precipitate delirium can be modified to reduce its presence and duration through non-pharmacological measures. Thus, the present protocol seeks to establish the theoretical and methodological background to develop and test nursing interventions to reduce delirium in adult patients hospitalized in the intensive care unit. For this reason, it is based on the theoretical elements of delirium and a nursing theory, called the Dynamic Symptoms Model (DSM), to understand the phenomenon and how nursing knowledge can be used to intervene. Thus, a nursing intervention proposal is proposed based on the DSM and scientific evidence, and a methodological design of a randomized controlled clinical trial type with parallel groups, which allows measuring the effectiveness of the designed interventions, following methodological and ethical rigor and with adequate control of biases.

Aim: to evaluate the clinical efficacy of an acetaminophen analgesic by comparing its prescription in fixed versus on-demand schedules after periodontal surgery. The hypothesis of the study was that the fixed regimen would be more effective than the on-demand regimen for postoperative analgesics following periodontal surgery. Methods: An open randomized clinical trial was conducted. The 68 patients who needed total flap surgery to restore supracrestal tissue attachment or surgical treatment of periodontitis were randomized". Visual Analogue Scale was used to assess pain. The fixed group (n = 34) received 500 mg of acetaminophen every 4 hours for 2 days. The on-demand group (n = 34) was instructed to use the acetaminophen "as needed," at intervals of no less than 4 hours between doses. Ibuprofen was the rescue medication for both groups. Pain scores and medication use were recorded 2, 6, 12, 24 and 48 hours after the surgical procedure. The study was registered at the Brazilian Registry of Clinical Trials under RBR-7wv259. Results: The two groups did not differ in relation to the frequency or the intensity of pain in a 48-hour period (n=20 in the fixed group, and n=22 in the on-demand group), or even in the intention-to-treat (n=34 in each group). Individuals who experienced moderate to severe pain used rescue medication more frequently in both groups. No adverse events were reported. Conclusion: Both regimens were effective in controlling postoperative pain after periodontal surgery. [ABSTRACT FROM AUTHOR]

In an equivalence trial, researchers aim to show that a new intervention is more or less similar to an existing standard of care, i.e., the two are “equivalent”. In this article, we discuss some aspects of the design, analysis, interpretation and reporting of equivalence trials.

Studies sometimes aim to show that a new intervention is not substantially worse than the existing standard of care while offering some benefits, for example, lower cost, decreased toxicity, or easier administration. Such studies are called non-inferiority (NI) trials. In this article, we look at some aspects of NI trials.

Dental implant restoration is a predictable treatment option for replacing missing or damaged teeth. Conventional loading requires a prolonged treatment period and second surgical interventions. The aim of this study was to compare the clinical outcomes between immediate and non-immediate (early or conventional) loading in single-implant restorations. A literature search of the PubMed, Embase, Cochrane Library, Web of Science, and ClinicalTrials.gov databases was performed in January 2020. Only randomized clinical trials (RCTs) were included. The overall risk ratios (RRs), mean differences (MDs), and 95% confidence intervals (CIs) were used in the analyses. A total of 10 RCTs reporting on 423 patients were included. There was no significant difference in any of the outcomes of interest between the immediate and non-immediate loading cases: implant failure at the patient level (RR 1.29, 95% CI 0.35 to 4.78, P = 0.71), implant failure at the implant level (RR 1.19, 95% CI 0.40 to 3.51, P = 0.75), marginal bone loss (MD −0.04, 95% CI −0.16 to 0.08, P = 0.54). Subgroup analyses showed similar results. Immediate loading had predictable long-term clinical outcomes if the indicated patients were carefully selected. The influences of several technical factors need to be confirmed in additional clinical trials. [ABSTRACT FROM AUTHOR]

Aim: This study aimed to assess the effects of telenursing on patients' activities of daily living and instrumental activities of daily living (ADLs and IADLs) following a myocardial infarction (MI). Methods: This randomized, parallel‐group, controlled trial was conducted on 95 patients post‐MI from 2018 to 2019. Patients were randomly assigned to the intervention (telenursing) and control groups using permuted block randomization. Through telephone calls, telenursing was performed twice a week during the first six consecutive weeks, then once a week until week 12. ADL and IADL questionnaires were completed by both groups before intervention and 12 weeks later. The CONSORT 2010 checklist was used to report the study protocol. Results: The mean age of patients was 56.8 ± 11.07 and 54.2 ± 9.8 years in the telenursing and control group, respectively. The mean ADL and IADL scores in the telenursing group were substantially greater than in the control group [4.57 (3.18, 5.97); P < 0.001 and 4.40 (3.06, 5.75); P < 0.001, respectively]. The odds of a higher degree of independence (no disabilities vs. mild disabilities and disability as well as no disabilities and mild disabilities vs. disability) regarding ADLs and IADLs were significantly greater in the telenursing group as compared with the control group (P < 0.001 and P < 0.001, respectively). Conclusions: Our findings suggest that the use of telenursing intervention may increase patients' ADLs and IADLs after an MI and may enhance their independence. Geriatr Gerontol Int 2022; 22: 616–622. [ABSTRACT FROM AUTHOR]

Background: In primary care (PC) many patients suffer from multimorbidity involving depression and/or anxiety. Collaborative care (CC) has shown promising results for patients with depression, anxiety, and multimorbidity involving depression. However, specific content in CC for patients with multimorbidity involving depression and/or anxiety is unknown.Objective: (i) To examine the effect of CC interventions in patients with multimorbidity involving depression and/or anxiety compared with usual care; (ii) to identify specific content of CC.Methods: We conducted a systematic literature review of randomized controlled trial studies evaluating CC models for adults with multimorbidity involving depression and/or anxiety in PC settings. PubMed, CINAHL, Web of Science, and PsycInfo were searched in December 2019. We conducted a qualitative synthesis using an existing framework and developed a new framework to map the content for each studied intervention.Results: We identified 1,447 studies. Twelve publications were included. Eleven had medium-to-high quality of CC for patients with multimorbidity involving depression. Specific content of CC in these studies is: A stepped care model, involving medication and psychotherapy delivered by a nurse or psychologist Care Manager (CM) focusing on problem-solving techniques; follow-up including monitoring of symptoms and function, and relapse prevention strategies; scheduled CM supervision.Conclusions: Specific content for CC for patients with multimorbidity involving depression is identified from current research. Research gaps were found regarding CC for patients with multimorbidity and anxiety, depression and anxiety, and depression and/or anxiety and more than 2 diseases. [ABSTRACT FROM AUTHOR]

Abstract Background Healthcare decisions are ideally based on clinical trial results, published in study registries, as journal articles or summarized in secondary research articles. In this research project, we investigated the impact of academically and commercially sponsored clinical trials on medical practice by measuring the proportion of trials published and cited by systematic reviews and clinical guidelines. Methods We examined 691 multicenter, randomized controlled trials that started in 2005 or later and were completed by the end of 2016. To determine whether sponsorship/funding and place of conduct influence a trial’s impact, we created four sub-cohorts of investigator initiated trials (IITs) and industry sponsored trials (ISTs): 120 IITs and 171 ISTs with German contribution compared to 200 IITs and 200 ISTs without German contribution. We balanced the groups for study phase and place of conduct. German IITs were funded by the German Research Foundation (DFG), the Federal Ministry of Education and Research (BMBF), or by another non-commercial research organization. All other trials were drawn from the German Clinical Trials Register or ClinicalTrials.gov. We investigated, to what extent study characteristics were associated with publication and impact using multivariable logistic regressions. Results For 80% of the 691 trials, results were published as result articles in a medical journal and/or study registry, 52% were cited by a systematic review, and 26% reached impact in a clinical guideline. Drug trials and larger trials were associated with a higher probability to be published and to have an impact than non-drug trials and smaller trials. Results of IITs were more often published as a journal article while results of ISTs were more often published in study registries. International ISTs less often gained impact by inclusion in systematic reviews or guidelines than IITs. Conclusion An encouraging high proportion of the clinical trials were published, and a considerable proportion gained impact on clinical practice. However, there is still room for improvement. For publishing study results, study registries have become an alternative or complement to journal articles, especially for ISTs. IITs funded by governmental bodies in Germany reached an impact that is comparable to international IITs and ISTs.

Early into COVID, human challenge trials were considered, but usually as alternatives to conventional randomized controlled trials. Instead, assessment of authorized COVID vaccines, of further COVID vaccines, and of vaccines against future pandemics should combine both designs, in five different ways, including a wholly novel one that we elaborate, Viz., combining data from both designs to answer a single question. [ABSTRACT FROM AUTHOR]

In 2014–2015, we conducted a randomized controlled trial (RCT) assessing the effect of an advertising campaign for influenza vaccination using posters and pamphlets in general practitioner (GP) waiting rooms. No effect of the intervention could be demonstrated, but the immunization uptake increased in both arms of the study. In 2019, we deepened the investigations explaining the increased uptake conducting a registry-based 4/2/1 cluster RCT designed by Zelen with two extra years of follow-up of the study cohort. The study population included 23,024 patients eligible to be vaccinated who were registered with 175 GPs. The main outcome remained the number of vaccination units delivered per study group. Data were extracted from the SNIIRAM warehouse claim database for the Lille-Douai district (northern France). No difference in vaccination uptake was found in the Zelen versus the control group of the initial RCT. Overall, the proportion of vaccinated patients increased in the cohort from 51.4% to 70.4% over the three years. Being vaccinated the previous year was a strong predictor of being vaccinated in a subsequent year. The increase in vaccination uptake, especially among people older than 65, can be explained by a cohort effect. Health promotion and the promotion of primary health care may play an important role in this increase. [ABSTRACT FROM AUTHOR]

Abstract Background Randomized controlled trials in orthopaedics are powered to mainly find large effect sizes. A possible discrepancy between the estimated and the real mean difference is a challenge for statistical inference based on p-values. We explored the justifications of the mean difference estimates used in power calculations. The assessment of distribution of observations in the primary outcome and the possibility of ceiling effects were also assessed. Methods Systematic review of the randomized controlled trials with power calculations in eight clinical orthopaedic journals published between 2016 and 2019. Trials with one continuous primary outcome and 1:1 allocation were eligible. Rationales and references for the mean difference estimate were recorded from the Methods sections. The possibility of ceiling effect was addressed by the assessment of the weighted mean and standard deviation of the primary outcome and its elaboration in the Discussion section of each RCT where available. Results 264 trials were included in this study. Of these, 108 (41 %) trials provided some rationale or reference for the mean difference estimate. The most common rationales or references for the estimate of mean difference were minimal clinical important difference (16 %), observational studies on the same subject (8 %) and the ‘clinical relevance’ of the authors (6 %). In a third of the trials, the weighted mean plus 1 standard deviation of the primary outcome reached over the best value in the patient-reported outcome measure scale, indicating the possibility of ceiling effect in the outcome. Conclusions The chosen mean difference estimates in power calculations are rarely properly justified in orthopaedic trials. In general, trials with a patient-reported outcome measure as the primary outcome do not assess or report the possibility of the ceiling effect in the primary outcome or elaborate further in the Discussion section.

In an equivalence trial, researchers aim to show that a new intervention is more or less similar to an existing standard of care, i.e., the two are "equivalent". In this article, we discuss some aspects of the design, analysis, interpretation and reporting of equivalence trials. [ABSTRACT FROM AUTHOR]

Objective: The Recruitment Innovation Center (RIC), partnering with the Trial Innovation Network and institutions in the National Institutes of Health-sponsored Clinical and Translational Science Awards (CTSA) Program, aimed to develop a service line to retrieve study population estimates from electronic health record (EHR) systems for use in selecting enrollment sites for multicenter clinical trials. Our goal was to create and field-test a low burden, low tech, and high-yield method.Materials and Methods: In building this service line, the RIC strove to complement, rather than replace, CTSA hubs' existing cohort assessment tools. For each new EHR cohort request, we work with the investigator to develop a computable phenotype algorithm that targets the desired population. CTSA hubs run the phenotype query and return results using a standardized survey. We provide a comprehensive report to the investigator to assist in study site selection.Results: From 2017 to 2020, the RIC developed and socialized 36 phenotype-dependent cohort requests on behalf of investigators. The average response rate to these requests was 73%.Discussion: Achieving enrollment goals in a multicenter clinical trial requires that researchers identify study sites that will provide sufficient enrollment. The fast and flexible method the RIC has developed, with CTSA feedback, allows hubs to query their EHR using a generalizable, vetted phenotype algorithm to produce reliable counts of potentially eligible study participants.Conclusion: The RIC's EHR cohort assessment process for evaluating sites for multicenter trials has been shown to be efficient and helpful. The model may be replicated for use by other programs. [ABSTRACT FROM AUTHOR]

The objective of clinical trials is to answer about intervention in the real-world, for which they must be properly designed and executed by presenting the results reliably with the findings and in a clear way. OBJECTIVES: To identify the risk of bias in clinical trials about interventions for diabetic retinopathy and/or diabetic macular edema from Cochrane systematic reviews. METHODS: A sensitive search strategy was designed to search Cochrane systematic reviews of interventions in diabetic retinopathy and diabetic macular edema. The assessment of the risk of bias was captured as presented by the author. FINDINGS: We found eight SR and one meta-analysis network totaling 116 randomized clinical trials. Our sample revealed that among the domains randomization, allocation secret, masking of participants and personnel, incomplete outcomes, selective outcomes and others, the risk of bias assessed as low ranged from 30.4 to 49.1%; unclear risk between 22 to 56% and high risk from 1 to 21.7%. CONCLUSIONS: The risk of bias in diabetic retinopathy randomized clinical trials exists in high frequency and the reader must be aware of it.

Objective: To describe and evaluate the xylitol products’ applicability and its effects in the health area worldwide utilizing a bibliometric analysis from randomized controlled trials (RCT) with humans. Material and Methods: Electronic searches were carried out in Medline/PubMed, Scopus, Cochrane Library, Web of Science, and VHL databases. The main data extracted were: year, area of applicability, type of treatment, country, journal, xylitol posology and concentration, presentation form, outcomes, and effects. Results: From 1476 studies, 257 were included. These studies were published between 1973-2021. The majority was carried out in dentistry (73.9%) and under preventive treatment (67.4%). These studies were developed in the USA (15.4%) and published in Caries Research (6.6%). The posology and concentration ranged between 0.004-67 g/day and 0.002-100%, respectively. The xylitol is usually used in the chewing gum form (44.0%), and for antimicrobial activity evaluation (38.5%). A positive effect was observed in 204 studies (79.3%) and was associated with xylitol concentration ≥ 15% (p=0.007). Side effects were reported in 8.2% and were associated with posology ≥ 5 g/day (p=0.03). Conclusion: Most studies with xylitol were conducted to prevent diseases in the dentistry field. The chewing gum form and antimicrobial activity evaluation were more frequent. Most xylitol products have a positive effect, and few studies report side effects.

In cancer randomized controlled trials, surrogate endpoints are frequently time‐to‐event endpoints, subject to the competing risk from the time‐to‐event clinical outcome. In this context, we introduce a counterfactual‐based mediation analysis for a causal assessment of surrogacy. We use a multistate model for risk prediction to account for both direct transitions towards the clinical outcome and indirect transitions through the surrogate outcome. Within the counterfactual framework, we define natural direct and indirect effects with a causal interpretation. Based on these measures, we define the proportion of the treatment effect on the clinical outcome mediated by the surrogate outcome. We estimate the proportion for both the cumulative risk and restricted mean time lost. We illustrate our approach by using 18‐year follow‐up data from the SPCG‐4 randomized trial of radical prostatectomy for prostate cancer. We assess time to metastasis as a surrogate outcome for prostate cancer‐specific mortality. [ABSTRACT FROM AUTHOR]

Studies sometimes aim to show that a new intervention is not substantially worse than the existing standard of care while offering some benefits, for example, lower cost, decreased toxicity, or easier administration. Such studies are called non-inferiority (NI) trials. In this article, we look at some aspects of NI trials. [ABSTRACT FROM AUTHOR]

Purpose: to evaluate the effect of dentifrice pH and fluoride concentration ([F]) on fluoride uptake on the biofilm and nails of children from a non-fluoridated area. Methods: two hundred and twenty-eight twoto four-year-old children were randomly allocated into 3 groups according to the type of dentifrice: G1: 1100 µg F/g, pH 4.5 (n = 76); G2: 750 µg F/g, pH 4.5 (n = 74); and G3: 1100 µg F/g, pH 7.0 (n = 78). Nails were collected at 4, 8, and 12 months after starting dentifrice use and biofilm was collected 5 and 60 minutes after toothbrushing. The concentrations of F in nails and biofilm were analyzed by HMDS facilitated diffusion. Data were analyzed by Kruskal-Wallis/Mann-Whitney's test and the comparison between biofilm collection times was done using Wilcoxon test (p £ 0.05). Results: a significant reduction of [F] in biofilm was observed 60 minutes after toothbrushing, regardless of the dentifrice used. However, 5 minutes after toothbrushing, G1 had a significantly higher [F] compared to G2 and G3, and 60 minutes after toothbrushing, [F] was significantly higher for G1 and G2 compared to G3. G1 and G3 had significantly higher [F] in the nails compared to G2. Conclusion: a lower dentifrice concentration is a relevant factor for the reduction of excessive fluoride intake. The use of a low-F acidified dentifrice combines the reduction of fluoride uptake with caries prevention by leading to greater incorporation of F into the biofilm over time. [ABSTRACT FROM AUTHOR]

Objective: To describe and evaluate the xylitol products’ applicability and its effects in the health area worldwide utilizing a bibliometric analysis from randomized controlled trials (RCT) with humans. Material and Methods: Electronic searches were carried out in Medline/PubMed, Scopus, Cochrane Library, Web of Science, and VHL databases. The main data extracted were: year, area of applicability, type of treatment, country, journal, xylitol posology and concentration, presentation form, outcomes, and effects. Results: From 1476 studies, 257 were included. These studies were published between 1973-2021. The majority was carried out in dentistry (73.9%) and under preventive treatment (67.4%). These studies were developed in the USA (15.4%) and published in Caries Research (6.6%). The posology and concentration ranged between 0.004-67 g/day and 0.002-100%, respectively. The xylitol is usually used in the chewing gum form (44.0%), and for antimicrobial activity evaluation (38.5%). A positive effect was observed in 204 studies (79.3%) and was associated with xylitol concentration ≥ 15% (p=0.007). Side effects were reported in 8.2% and were associated with posology ≥ 5 g/day (p=0.03). Conclusion: Most studies with xylitol were conducted to prevent diseases in the dentistry field. The chewing gum form and antimicrobial activity evaluation were more frequent. Most xylitol products have a positive effect, and few studies report side effects. [ABSTRACT FROM AUTHOR]

Copyright of Journal of Evidence-based Healthcare is the property of Journal of Evidence-based Healthcare and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background: Definitions of dichotomous outcome terms, such as "response," "remission," and "recovery" are central to the design, interpretation, and clinical application of randomized controlled trials of adolescent depression interventions. Accordingly, this scoping review was conducted to document how these terms have been defined and justified in clinical trials.Method: Bibliographic databases MEDLINE, Embase, APA PsycInfo, and CINAHL were searched from inception to February 2020 for randomized controlled trials evaluating treatments for adolescent depression. Ninety-eight trials were included for data extraction and analysis.Results: Assessment of outcome measurement instruments, metric strategies, methods of aggregation, and measurement timing, yielded 53 unique outcome definitions of "response" across 45 trials that assessed response, 47 unique definitions of "remission" in 29 trials that assessed remission, and 19 unique definitions of "recovery" across 11 trials that assessed recovery. A minority of trials (N = 35) provided a rationale for dichotomous outcomes definitions, often by citing other studies that used a similar definition (N = 11). No rationale included input from youth or families with lived experience.Conclusion: Our review revealed that definitions of "response," "remission," "recovery," and related terms are highly variable, lack clear rationales, and are not informed by key stakeholder input. These limitations impair pooling of trial results and the incorporation of trial findings into pragmatic treatment decisions in clinical practice. Systematic approaches to establishing outcome definitions are needed to enhance the impact of trials examining adolescent depression treatment. [ABSTRACT FROM AUTHOR]

Background: Healthcare decisions are ideally based on clinical trial results, published in study registries, as journal articles or summarized in secondary research articles. In this research project, we investigated the impact of academically and commercially sponsored clinical trials on medical practice by measuring the proportion of trials published and cited by systematic reviews and clinical guidelines.Methods: We examined 691 multicenter, randomized controlled trials that started in 2005 or later and were completed by the end of 2016. To determine whether sponsorship/funding and place of conduct influence a trial's impact, we created four sub-cohorts of investigator initiated trials (IITs) and industry sponsored trials (ISTs): 120 IITs and 171 ISTs with German contribution compared to 200 IITs and 200 ISTs without German contribution. We balanced the groups for study phase and place of conduct. German IITs were funded by the German Research Foundation (DFG), the Federal Ministry of Education and Research (BMBF), or by another non-commercial research organization. All other trials were drawn from the German Clinical Trials Register or ClinicalTrials.gov. We investigated, to what extent study characteristics were associated with publication and impact using multivariable logistic regressions.Results: For 80% of the 691 trials, results were published as result articles in a medical journal and/or study registry, 52% were cited by a systematic review, and 26% reached impact in a clinical guideline. Drug trials and larger trials were associated with a higher probability to be published and to have an impact than non-drug trials and smaller trials. Results of IITs were more often published as a journal article while results of ISTs were more often published in study registries. International ISTs less often gained impact by inclusion in systematic reviews or guidelines than IITs.Conclusion: An encouraging high proportion of the clinical trials were published, and a considerable proportion gained impact on clinical practice. However, there is still room for improvement. For publishing study results, study registries have become an alternative or complement to journal articles, especially for ISTs. IITs funded by governmental bodies in Germany reached an impact that is comparable to international IITs and ISTs. [ABSTRACT FROM AUTHOR]

To determine the: 1) quality of articles cited in systematic reviews (SRs); 2) methodological quality of the SRs; and 3) impact of quality on level 1A evidence. SRs related to musculoskeletal physical therapy interventions were identified. The methodological quality of the SRs and articles cited by the SRs were assessed by two blinded reviewers. Data analysis was performed by a third blinded researcher. Additional comparisons were made based on the Journal Impact Factor, spin, financial bias, and conflict of interest. Twenty-four SRs were identified; 21/24 SRs had 'critically low' quality on the AMSTAR 2. Thirty-four percent of included studies were 'low quality,' and 58% of SRs included studies that had unreported external validity. One-half of the SRs represented 'spin,' and one-third of the SRs generated conclusions based on low-quality clinical trials. The 'critically low' SRs methodological quality was exacerbated by low-quality research inclusion. Most SRs failed to follow best practices, including prospective registration and integration of professional librarians in the search process. Based on the high proportion of SRs that include low-quality trials and overall low methodological quality, further discussion regarding practice recommendations on level vs. quality of evidence is warranted. 1a [ABSTRACT FROM AUTHOR]

Background: Diabetes mellitus is a chronic, degenerative disease, requiring a multi-dimensional, multi-professional care by healthcare providers and substantial self-care by the patients, to achieve treatment goals. Objective: To evaluate the impact of pharmacist-led care on glycaemic control in patients with uncontrolled Type 2 Diabetes Methods: In a parallel group, single-blind randomised controlled study; type 2 diabetic patients, with greater than 7% glycated haemoglobin (A1C) were randomised into intervention and usual care groups and followed for six months. Glycated haemoglobin analyzer, lipid analyzer and blood pressure monitor/apparatus were used to measure patients' laboratory parameters at baseline and six months. Intervention group patients received pharmacist-structured care, made up of patient education and phone calls, in addition to usual care. In an intention to treat analysis, Mann-Whitney U test was used to compare median change at six months in the primary (A1C) and secondary outcome measures. Effect size was computed and proportion of patients that reached target laboratory parameters were compared in both arms. Results: All enrolled participants (108) completed the study, 54 in each arm. Mean age was 51 (SD 11.75) and majority were females (68.5%). Participants in the intervention group had significant reduction in A1C of -0.75%, compared with an increase of 0.15% in the usual care group (p<0.001; eta-square= 0.144). The proportion of those that achieved target A1C of <7% at 6 months in the intervention and usual care group was 42.6% vs 20.8% (p=0.02). Furthermore, intervention patients were about 3 times more likely to have better glucose control; A1C<7% (aOR 2.72, 95%CI: 1.14-6.46) compared to usual care group, adjusted for sex, age, and duration of diabetes. Conclusions: Pharmacist-led care significantly improved glycaemic control in patients with uncontrolled T2DM. [ABSTRACT FROM AUTHOR]

Background: Successful diabetes treatment requires commitment and understanding of disease management by the patients. Objective: This trial aimed to evaluate the programme effectiveness of home medication review by community pharmacists (HMR-CP) in optimising diabetes care and reducing medication wastage. Methods: A randomised controlled trial was conducted on 166 patients with Type 2 Diabetes Mellitus (T2DM) who were randomly assigned to the intervention or control groups. The intervention group received HMR-CP at 0-month, 3-month, and 6-month. The primary outcome was haemoglobin A1c (HbA1c) while clinical outcomes, anthropometric data, and humanistic outcomes were the secondary outcomes. For the intervention group, drug-related problems (DRP) were classified according to the Pharmaceutical Care Network Europe Foundation (PCNE). Medication adherence was determined based on the Pill Counting Adherence Ratio (PCAR). The cost of medication wastage was calculated based on the total missed dose by the T2DM patients multiplied by the cost of medication. General linear model and generalised estimating equations were used to compare data across the different time-points within and between the groups, respectively. Results: No significant difference was observed in the demographic and anthropometric data at baseline between the two groups except for fasting blood glucose (FBG). There was a significant reduction in the HbA1c (-0.91%) and FBG (-1.62mmol/L) over the study period (p<0.05). A similar observation was noted in diastolic blood pressure (DBP) and total cholesterol (TC) but not in high-density lipoprotein (HDL), and anthropometric parameters. Both utility value and Michigan Diabetes Knowledge Test (MDKT) scores increased significantly over time. As for the intervention group, significant changes in PCAR (p<0.001) and the number of DRP (p<0.001) were noted. Conclusions: HMR-CP significantly improved the glycaemic control, QoL, medication adherence, and knowledge of T2DM patients as well as reduced the number of DRP and cost of medication wastage. However, the impact of HMR-CP on certain clinical and anthropometric parameters remains inconclusive and further investigation is warranted. [ABSTRACT FROM AUTHOR]

Background: Outcome discrepancies between protocols and respective publications represent a concerning bias. The purpose of this study was to assess the prevalence of selective outcome reporting (SOR) in root coverage randomized clinical trials (RCTs). Methods: Published root coverage RCTs (July 2005 to March 2020) were included if a corresponding protocol could be identified in a public registry. Discrepancies between protocol and its correspondent publication(s) were compared regarding primary and secondary outcomes and other study characteristics. Associations between trial characteristics and SOR were evaluated. Results: Forty four studies (54 publications) were included. The majority of studies (77.3%) were retrospectively registered. SOR was frequent (40.9% of trials) and consisted of primary outcome downgrade (22.7%); secondary outcome upgrade (11.4%); new primary outcome introduced in publication (25%); protocol primary outcome omitted from publication (13.6%) and discrepancy in primary outcome timing (18.2%). SOR was unclear in 20.5% of studies and favoured statistical significance in 12 studies (27.3%). SOR was significantly associated with study significance (p < 0.001) and unclear outcome definition in the publication (p < 0.001). Only a third (32.8%) of primary outcomes were completely defined. Conclusions: The present study identified high prevalence of SOR in root coverage RCTs. [ABSTRACT FROM AUTHOR]

Study Design Randomized controlled single-blinded clinical trial. Purpose To evaluate the efficacy of Schroth therapy on thoracic curve angle, pain, and self-perceived body image (SPBI) of the back in Scheuermann’s patients in comparison with the efficacy of classic anti-gravitation exercises. Overview of Literature Scheuermann disease is the most common cause of hyperkyphosis of the thoracic and thoracolumbar spine during adolescence. However, very few studies evaluated the effect of exercises on the progression of kyphosis in Scheuermann patients. Schroth three-dimensional exercise therapy was found in several studies to be effective in the treatment of adolescent scoliosis; however, we found no randomized controlled trials that evaluated the efficacy of this method in Scheuermann patients. Methods A total of 50 young adults (males and females) with Scheuermann’s disease were randomly divided into either the experimental group (Schroth therapy treatment, n=25) or the control group (classic anti-gravitation exercises, n=25). Participants in both the groups were provided a course of individual treatment sessions during few weeks, with one appointment per week. They were required to perform the exercises daily throughout the study period (12 months) and fill their performance in a research log. We evaluated the thoracic Cobb angle (main outcome measure), pain, SPBI, flexion of the shoulder (supine), flexion of the shoulder (standing), kyphotic deformity measured using inclinometer, and L5 kyphosis apex line (L5-KAL) as well as administered the Scoliosis Research Society-22 Questionnaire for the participants before the treatment, after 6 months, and 1 year postoperatively. These results were then compared. Results In the mixed analysis of variance, the main effect of time was significant in the thoracic kyphosis (F [1]=5.72, p=0.02), and in the L5-KAL (F [1]=5.76, p=0.02). The main effect of time on the kyphotic deformity, measured using an inclinometer, did not reach the significance level; however, it showed the tendency (F [1]=2.80, p=0.07). In the group-by-time interaction, a significant difference was found in the thoracic kyphosis (F [1]=4.91, p=0.03) and in the kyphotic deformity, measured using an inclinometer (F [1]=4.05, p=0.02). Thus, the Schroth therapy group showed significantly greater improvement than the classic anti-gravitation exercises group. Conclusions The present findings indicate that back exercises in general, and Schroth therapy in particular, is an effective treatment for preventing and significantly improving the thoracic Cobb angle and symptomatic representation in Scheuermann’s patients.

This publication is the Russian translation of the Plain Language Summary (PLS) of the Cochrane Systematic Review: Desborough MJR, Hadjinicolaou AV, Chaimani A, Trivella M, Vyas P, Doree C, Hopewell S, Stanworth SJ, Estcourt LJ. Alternative agents to prophylactic platelet transfusion for preventing bleeding in people with thrombocytopenia due to chronic bone marrow failure: a meta-analysis and systematic review. Cochrane Database of Systematic Reviews 2016, Issue 10. Art. No.: CD012055. DOI: 10.1002/14651858.CD012055.pub2