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AnteayerBMJ Open

Do patients with type 2 diabetes mellitus included in randomised clinical trials differ from general-practice patients? A cross-sectional comparative study

Por: Dugard · A. · Giraudeau · B. · Dibao-Dina · C.
Objectives

To compare the characteristics of patients with type 2 diabetes mellitus in general practice and those included in randomised controlled trials on which clinical practice guidelines are based.

Design

Cross-sectional comparative study.

Setting

We asked 45 general practitioners from three French Departments to identify the 15 patients with type 2 diabetes mellitus they most recently saw in consultation. In parallel, we selected randomised controlled trials included in the Cochrane systematic review on which the clinical practice guidelines for type 2 diabetes mellitus were based.

Participants

We included 675 patients with type 2 diabetes mellitus, and data were collected from 23 randomised controlled trials, corresponding to 36 059 patients.

Outcome measures

Characteristics of general-practice patients were extracted from medical records by a unique observer. The same baseline characteristics of patients included in randomised controlled trials from the Cochrane systematic review were extracted and meta-analysed. We assessed standardised differences between these two series of baseline characteristics. A difference greater than 0.10 in absolute value was considered meaningful.

Results

General-practice patients were older than randomised controlled trial patients (mean (SD) 68.8 (1.1) vs 59.9 years (standardised difference 0.8)) and had a higher body mass index (mean (SD) 31.5 (6.9) vs 28.2 kg/m2 (standardised difference 0.5)) but smoked less (11.0% vs 29.3% (standardised difference –0.6)). They more frequently used antihypertensive drugs (82.1% vs 37.5% (standardised difference 1.2)) but less frequently had a myocardial infarction (7.6% vs 23.1% (standardised difference –1.1)).

Conclusions

Patients with type 2 diabetes mellitus cared for in general practice differ in a number of important aspects from patients included in randomised controlled trials on which clinical practice guidelines are based. This situation hampers the applicability of these guidelines. Future randomised trials should include patients who better fit the ‘average’ general-practice patient with type 2 diabetes mellitus to help improve the translation of study findings in daily practice.

Supplements for cognitive ability in patients with mild cognitive impairment or Alzheimers disease: a protocol for systematic review and network meta-analysis of randomised controlled trials

Por: Zhang · X.-Y. · Li · Y.-Q. · Yin · Z.-H. · Bao · Q.-N. · Xia · M.-Z. · Chen · Z.-H. · Zhong · W.-Q. · Wu · K.-X. · Yao · J. · Liang · F.-R.
Introduction

Considering the increasing incidence of Alzheimer’s disease (AD) and mild cognitive impairment (MCI) worldwide, there is an urgent need to identify efficacious, safe and convenient treatments. Numerous investigations have been conducted on the use of supplements in this domain, with oral supplementation emerging as a viable therapeutic approach for AD or MCI. Nevertheless, given the multitude of available supplements, it becomes imperative to identify the optimal treatment regimen.

Methods and analysis

Eight academic databases and three clinical trial registries will be searched from their inception to 1 June 2023. To identify randomised controlled trials investigating the effects of supplements on patients with AD or MCI, two independent reviewers (X-YZ and Y-QL) will extract relevant information from eligible articles, while the risk of bias in the included studies will be assessed using the Rob 2.0 tool developed by the Cochrane Collaboration. The primary outcome of interest is the overall cognitive function. Pair-wise meta-analysis will be conducted using RevMan V.5.3, while network meta-analysis will be carried out using Stata 17.0 and ADDIS 1.16.8. Heterogeneity test, data synthesis and subgroup analysis will be performed if necessary. The GRADE system will be employed to assess the quality of evidence. This study is scheduled to commence on 1 June 2023 and conclude on 1 October 2023.

Ethics and dissemination

Ethics approval is not required for systematic review and network meta-analysis. The results will be submitted to a peer-reviewed journal or at a conference.

Trial registration number

PROSPERO (CRD42023414700).

Effects of opioid-free anaesthesia compared with balanced general anaesthesia on nausea and vomiting after video-assisted thoracoscopic surgery: a single-centre randomised controlled trial

Por: Bao · R. · Zhang · W.-s. · Zha · Y.-f. · Zhao · Z.-z. · Huang · J. · Li · J.-l. · Wang · T. · Guo · Y. · Bian · J.-j. · Wang · J.-f.
Objectives

Opioid-free anaesthesia (OFA) has emerged as a promising approach for mitigating the adverse effects associated with opioids. The objective of this study was to evaluate the impact of OFA on postoperative nausea and vomiting (PONV) following video-assisted thoracic surgery.

Design

Single-centre randomised controlled trial.

Setting

Tertiary hospital in Shanghai, China.

Participants

Patients undergoing video-assisted thoracic surgery were recruited from September 2021 to June 2022.

Intervention

Patients were randomly allocated to OFA or traditional general anaesthesia with a 1:1 allocation ratio.

Primary and secondary outcome measures

The primary outcome measure was the incidence of PONV within 48 hours post-surgery, and the secondary outcomes included PONV severity, postoperative pain, haemodynamic changes during anaesthesia, and length of stay (LOS) in the recovery ward and hospital.

Results

A total of 86 and 88 patients were included in the OFA and control groups, respectively. Two patients were excluded because of severe adverse events including extreme bradycardia and epilepsy-like convulsion. The incidence and severity of PONV did not significantly differ between the two groups (29 patients (33.0%) in the control group and 22 patients (25.6%) in the OFA group; relative risk 0.78, 95% CI 0.49 to 1.23; p=0.285). Notably, the OFA approach used was associated with an increase in heart rate (89±17 vs 77±15 beats/min, t-test: p

Conclusions

Our study findings suggest that the implementation of OFA does not effectively reduce the incidence of PONV following thoracic surgery when compared with traditional total intravenous anaesthesia. The opioid-free strategy used in our study may be associated with severe adverse cardiovascular events.

Trial registration number

ChiCTR2100050738.

Assessing the impact of diverse mask types on COPD patients: a randomised controlled trial study protocol

Por: Chen · X. · Jiang · X. · Zhang · X. · Ren · D. · Wei · C. · Xu · A. · Yang · H. · Bai · R. · Li · C. · Yue · F. · Bao · S. · Shi · J. · Fan · J.
Introduction

Wearing masks has proven beneficial in preventing respiratory pathogen infections in individuals with chronic obstructive pulmonary disease (COPD). However, the impact of different mask types on physiological indicators and daily physical activity in COPD patients remains uncertain. This study aims to assess the immediate effects of various mask types on cardiopulmonary function indicators, subjective perceptions and the 6-minute walking distance (6MWD) in individuals with COPD.

Methods and analysis

This randomised controlled trial will enrol 129 stable COPD patients. Participants will be randomly divided into three groups: control, N95 mask and surgical mask groups. Each group will undergo both a 6-minute seated test and a 6-minute walk test (6MWT), without or with their respective masks. A 10-minute interval will be provided between the two phases. The primary indicators of the study include the 6MWD and blood oxygen saturation. Secondary outcomes encompass blood pressure, pulse rate, Borg score, Rate of Perceived Exertion (RPE) score and subjective perception score. Oxygen saturation, pulse rate and blood pressure will be recorded four times during the trial, while Borg and RPE scores will be compared before and after the 6MWT. Additionally, subjective perception scores will be collected after each mask-wearing stage.

Ethics and dissemination

This study has received approval from the Ethics Committee of the Affiliated Hospital of Gansu University of Chinese Medicine (approval number: 202335). We plan to disseminate research results through publication in a peer-reviewed journal or presentation at a conference.

Trial registration number

ChiCTR2300074554.

Association between the triglyceride glucose index and low skeletal muscle mass: a cross-sectional study

Por: Li · Z. · Tong · X. · Ma · Y. · Bao · T. · Yue · J.
Objectives

Triglyceride glucose (TyG) represents a consistent surrogate biomarker and index of insulin resistance (IR), IR has also been linked to skeletal muscle mass loss (SMM-L). Here, we evaluated the association between SMM-L and the TyG index (TyGi).

Design

An analytical cross-sectional study.

Setting

Tertiary care hospitals.

Participants

36 275 participants who underwent health checks between 1 January 2013 and 31 December 2020.

Primary and secondary outcome measures

A bioelectrical impedance analysis was used to assess the body composition, SMM-L was defined as low ASMI (total limb lean mass/height2) and TyGi was calculated as ln(triglycerides (mg/dL)xfasting blood glucose (mg/dL)/2).

Results

A total of 36 275 subjects were included in the study, of which 58.46% were male, with a mean age of 43.74±12.33 years. The prevalence of low skeletal muscle mass (SMM) was 17.7% and the mean TyGi was 8.56±0.64. TyGi was found to be significantly correlated with low SMM in all subjects (OR 1.87, 95% CI 1.75 to 2.00, p

Conclusions

These data demonstrated a significant independent interaction between TyGi and low SMM in all subjects regardless of sex and age subgroups in the general population.

Key factors for effective implementation of healthcare workers support interventions after patient safety incidents in health organisations: a scoping review

Por: Guerra-Paiva · S. · Lobao · M. J. · Simoes · D. G. · Fernandes · J. · Donato · H. · Carrillo · I. · Mira · J. J. · Sousa · P.
Objectives

This study aims to map and frame the main factors present in support interventions successfully implemented in health organisations in order to provide timely and adequate response to healthcare workers (HCWs) after patient safety incidents (PSIs).

Design

Scoping review guided by the six-stage approach proposed by Arksey and O’Malley and by PRISMA-ScR.

Data sources

CINAHL, Cochrane Library, Embase, Epistemonikos, PsycINFO, PubMed, SciELO Citation Index, Scopus, Web of Science Core Collection, reference lists of the eligible articles, websites and a consultation group.

Eligibility criteria for selecting studies

Empirical studies (original articles) were prioritised. We used the Mixed Methods Appraisal Tool Version 2018 to conduct a quality assessment of the eligible studies.

Data extraction and synthesis

A total of 9766 records were retrieved (last update in November 2022). We assessed 156 articles for eligibility in the full-text screening. Of these, 29 earticles met the eligibility criteria. The articles were independently screened by two authors. In the case of disagreement, a third author was involved. The collected data were organised according to the Organisational factors, People, Environment, Recommendations from other Audies, Attributes of the support interventions. We used EndNote to import articles from the databases and Rayyan to support the screening of titles and abstracts.

Results

The existence of an organisational culture based on principles of trust and non-judgement, multidisciplinary action, leadership engagement and strong dissemination of the support programmes’ were crucial factors for their effective implementation. Training should be provided for peer supporters and leaders to facilitate the response to HCWs’ needs. Regular communication among the implementation team, allocation of protected time, funding and continuous monitoring are useful elements to the sustainability of the programmes.

Conclusion

HCWs’ well-being depends on an adequate implementation of a complex group of interrelated factors to support them after PSIs.

Multimodality local consolidative treatment versus conventional care of advanced lung cancer after first-line systemic anti-cancer treatment: study protocol for the RAMON multicentre randomised controlled trial with an internal pilot

Por: Beard · C. · Rogers · C. A. · Fleming · L. · Conibear · J. · Evison · M. · Newsom-Davis · T. · Barwick · T. · Mills · N. · Stokes · E. A. · De Sousa · P. · Batchelor · T. · Rawlinson · J. · Baos · S. · Harris · R. · Lim · E.
Introduction

Lung cancer is the most common cause of cancer death worldwide and most patients present with extensive disease. One-year survival is improving but remains low (37%) despite novel systemic anti-cancer treatments forming the current standard of care. Although new therapies improve survival, most patients have residual disease after treatment, and little is known on how best to manage it. Therefore, residual disease management varies across the UK, with some patients receiving only maintenance systemic anti-cancer treatment while others receive local consolidative treatment (LCT), alongside maintenance systemic anti-cancer treatment. LCT can be a combination of surgery, radiotherapy and/or ablation to remove all remaining cancer within the lung and throughout the body. This is intensive, expensive and impacts quality of life, but we do not know if it results in better survival, nor the extent of impact on quality of life and what the cost might be for healthcare providers. The RAMON study (RAdical Management Of Advanced Non-small cell lung cancer) will evaluate the acceptability, effectiveness and cost-effectiveness of LCT versus no LCT after first-line systemic treatment for advanced lung cancer.

Methods and analysis

RAMON is a pragmatic open multicentre, parallel group, superiority randomised controlled trial. We aim to recruit 244 patients aged 18 years and over with advanced non-small-cell lung cancer from 40 UK NHS hospitals. Participants will be randomised in a 1:1 ratio to receive LCT alongside maintenance treatment, or maintenance treatment alone. LCT will be tailored to each patient’s specific disease sites. Participants will be followed up for a minimum of 2 years. The primary outcome is overall survival from randomisation.

Ethics and dissemination

The West of Scotland Research Ethics Committee (22/WS/0121) gave ethical approval in August 2022 and the Health Research Authority in September 2022. Participants will provide written informed consent before participating in the study. Findings will be presented at international meetings, in peer-reviewed publications, through patient organisations and notifications to patients.

Trial registration number

ISRCTN11613852.

Predictive value of machine learning on fracture risk in osteoporosis: a systematic review and meta-analysis

Por: Wu · Y. · Chao · J. · Bao · M. · Zhang · N.
Objectives

Early identification of fracture risk in patients with osteoporosis is essential. Machine learning (ML) has emerged as a promising technique to predict the risk, whereas its predictive performance remains controversial. Therefore, we conducted this systematic review and meta-analysis to explore the predictive efficiency of ML for the risk of fracture in patients with osteoporosis.

Methods

Relevant studies were retrieved from four databases (PubMed, Embase, Cochrane Library and Web of Science) until 31 May 2023. A meta-analysis of the C-index was performed using a random-effects model, while a bivariate mixed-effects model was used for the meta-analysis of sensitivity and specificity. In addition, subgroup analysis was performed according to the types of ML models and fracture sites.

Results

Fifty-three studies were included in our meta-analysis, involving 15 209 268 patients, 86 prediction models specifically developed for the osteoporosis population and 41 validation sets. The most commonly used predictors in these models encompassed age, BMI, past fracture history, bone mineral density T-score, history of falls, BMD, radiomics data, weight, height, gender and other chronic diseases. Overall, the pooled C-index of ML was 0.75 (95% CI: 0.72, 0.78) and 0.75 (95% CI: 0.71, 0.78) in the training set and validation set, respectively; the pooled sensitivity was 0.79 (95% CI: 0.72, 0.84) and 0.76 (95% CI: 0.80, 0.81) in the training set and validation set, respectively; and the pooled specificity was 0.81 (95% CI: 0.75, 0.86) and 0.83 (95% CI: 0.72, 0.90) in the training set and validation set, respectively.

Conclusions

ML has a favourable predictive performance for fracture risk in patients with osteoporosis. However, most current studies lack external validation. Thus, external validation is required to verify the reliability of ML models.

PROSPERO registration number

CRD42022346896.

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