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AnteayerBMJ Open

Effects of different exercise interventions on chemotherapy-related cognitive impairment in patients with breast cancer: a study protocol for systematic review and network meta-analysis

Por: Dong · Y. · Huang · H. · Wang · A.
Introduction

Breast cancer stands as the most prevalent type of cancer affecting women globally, and chemotherapy plays a pivotal role in its treatment by diminishing tumour recurrence and enhancing the survival rates of patients. However, chemotherapy-related cognitive impairment (CRCI) often occurs in patients undergoing treatment. Although multiple clinical trials have indicated that exercise therapy can improve CRCI in patients with breast cancer, there are variations in the types of exercise interventions and their effectiveness. We aim to perform a pioneering network meta-analysis (NMA) to assess and prioritise the effectiveness of various exercise interventions in enhancing cognitive function in patients with breast cancer undergoing chemotherapy.

Methods and analysis

We will search multiple databases, including PubMed, Web of Science, Cochrane, Embase, China National Knowledge Infrastructure, VIP Database for Chinese Technical Periodicals, Wanfang and Sinomed databases, from their inception to May 2023. The main outcome is the cognitive function changes in patients with breast cancer, including subjective and objective results. We will specifically include randomised controlled trials reported in English and Chinese languages, whose primary outcome consists of an assessment of the cognitive function of patients with breast cancer using standardised and validated assessment tools, encompassing both subjective and objective outcomes. The quality of all the trials included will be evaluated based on ‘Version 2 of the Cochrane tool for assessing the risk of bias in randomized controlled trials (RoB2)’. We will conduct a Bayesian NMA to thoroughly evaluate and compare the effectiveness of different exercise interventions. We will use cumulative ranking probability plots to estimate the ranking of the best interventions for various exercises. Network plots and funnel plots will be employed to display the study sizes and participants of each exercise intervention, as well as potential publication biases.

Ethics and dissemination

The study findings will be shared via peer-reviewed journals to ensure the highest quality and credibility of the research. As the reporting will not include any private patient data, there are no ethical considerations associated with this protocol.

PROSPERO registration number

CRD42023406597.

Efficacy of electro-acupuncture versus sham acupuncture for diabetic peripheral neuropathy: study protocol for a three-armed randomised controlled trial

Por: Zhuang · R. · Xiong · Z. · Yan · S. · Zhang · H. · Dong · Q. · Liu · W. · Miao · J. · Zhuo · Y. · Fan · X. · Zhang · W. · Wang · X. · Liu · L. · Cao · J. · Zhang · T. · Hao · C. · Huang · X. · Jiang · L.
Introduction

Specific treatment for diabetic peripheral neuropathy (DPN) is still lacking, and acupuncture may relieve the symptoms. We intend to investigate the efficacy and safety of electro-acupuncture (EA) in alleviating symptoms associated with DPN in diabetes.

Methods and analysis

This multicentre, three-armed, participant- and assessor-blind, randomised, sham-controlled trial will recruit 240 eligible participants from four hospitals in China and will randomly assign (1:1:1) them to EA, sham acupuncture (SA) or usual care (UC) group. Participants in the EA and SA groups willl receive either 24-session EA or SA treatment over 8 weeks, followed by an 8-week follow-up period, while participants in the UC group will be followed up for 16 weeks. The primary outcome of this trial is the change in DPN symptoms from baseline to week 8, as rated by using the Total Symptom Score. The scale assesses four symptoms: pain, burning, paraesthesia and numbness, by evaluating the frequency and severity of each. All results will be analysed with the intention-to-treat population.

Ethics and dissemination

The protocol has been approved by the Ethics Committee of the Beijing University of Chinese Medicine (Identifier: 2022BZYLL0509). Every participant will be informed of detailed information about the study before signing informed consent. The results of this trial will be published in a peer-reviewed journal.

Trial registration number

ChiCTR2200061408.

Inhaled Nitric Oxide ReDuce postoperatIve pulmoNAry complicaTions in patiEnts with recent COVID-19 infection (INORDINATE): protocol for a randomised controlled trial

Por: Zheng · Z. · Wang · L. · Wang · S. · Fan · Q. · Zhang · H. · Luo · G. · Gao · B. · Yang · X. · Zhao · B. · Wang · X. · Dong · H. · Nie · H. · Lei · C.
Background

A history of SARS-CoV-2 infection has been reported to be associated with an increased risk of postoperative pulmonary complications (PPCs). Even mild PPCs can elevate the rates of early postoperative mortality, intensive care unit (ICU) admission and prolong the length of ICU and/or hospital stays. Consequently, it is crucial to develop perioperative management strategies that can mitigate these increased risks in surgical patients who have recently been infected with SARS-CoV-2. Accumulating evidence suggests that nitric oxide (NO) inhalation might be effective in treating COVID-19. NO functions in COVID-19 by promoting vasodilation, anticoagulation, anti-inflammatory and antiviral effects. Therefore, our study hypothesises that the perioperative use of NO can effectively reduce PPCs in patients with recent SARS-CoV-2 infection.

Method and analysis

A prospective, double-blind, single-centre, randomised controlled trial is proposed. The trial aims to include participants who are planning to undergo surgery with general anaesthesia and have been recently infected with SARS-CoV-2 (within 7 weeks). Stratified allocation of eligible patients will be performed at a 1:1 ratio based on the predicted risk of PPCs using the Assess Respiratory Risk in Surgical Patients in Catalonia risk index and the time interval between infection and surgery.

The primary outcome of the study will be the presence of PPCs within the first 7 days following surgery, including respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm and aspiration pneumonitis. The primary outcome will be reported as counts (percentage) and will be compared using a two-proportion 2 test. The common effect across all primary components will be estimated using a multiple generalised linear model.

Ethics and dissemination

The trial is approved by the Institutional Review Board of Xijing Hospital (KY20232058-F1). The findings, including positive, negative and inconclusive results, will be published in scientific journals with peer-review processes.

Trial registration number

NCT05721144.

Differences in inpatient performance of public general hospitals following implementation of a points-counting payment based on diagnosis-related group: a robust multiple interrupted time series study in Wenzhou, China

Por: Zhu · T. · Chen · C. · Zhang · X. · Yang · Q. · Hu · Y. · Liu · R. · Zhang · X. · Dong · Y.
Objectives

This study measures the differences in inpatient performance after a points-counting payment policy based on diagnosis-related group (DRG) was implemented. The point value is dynamic; its change depends on the annual DRGs’ cost settlements and points of the current year, which are calculated at the beginning of the following year.

Design

A longitudinal study using a robust multiple interrupted time series model to evaluate service performance following policy implementation.

Setting

Twenty-two public general hospitals (8 tertiary institutions and 14 secondary institutions) in Wenzhou, China.

Intervention

The intervention was implemented in January 2020.

Outcome measures

The indicators were case mix index (CMI), cost per hospitalisation (CPH), average length of stay (ALOS), cost efficiency index (CEI) and time efficiency index (TEI). The study employed the means of these indicators.

Results

The impact of COVID-19, which reached Zhejiang Province at the end of January 2020, was temporary given rapid containment following strict control measures. After the intervention, except for the ALOS mean, the change-points for the other outcomes (p0.05), the uptrend of the CEI mean in tertiary institutions alleviated (p0.05).

Conclusions

This study showed a positive effect of the DRG policy in Wenzhou, even during COVID-19. The policy can motivate public general hospitals to improve their comprehensive capacity and mitigate discrepancies in treatment expenses efficiency for similar diseases. Policymakers are interested in whether the reform successfully motivates hospitals to strengthen their internal impetus and improve their performance, and this is supported by this study.

Nephrologists perspectives on communication and decision-making regarding technique survival in peritoneal dialysis: an international qualitative interview study

Por: Yudianto · B. · Jaure · A. · Shen · J. · Cho · Y. · Brown · E. · Dong · J. · Dunning · T. · Mehrotra · R. · Naicker · S. · Pecoits-Filho · R. · Perl · J. · Wang · A. Y.-M. · Wilkie · M. · Guha · C. · Scholes-Robertson · N. · Craig · J. · Johnson · D. · Manera · K.
Objectives

Peritoneal dialysis (PD) allows patients increased autonomy and flexibility; however, both infectious and non-infectious complications may lead to technique failure, which shortens treatment longevity. Maintaining patients on PD remains a major challenge for nephrologists. This study aims to describe nephrologists’ perspectives on technique survival in PD.

Design

Qualitative semistructured interview study. Transcripts were thematically analysed.

Setting and participants

30 nephrologists across 11 countries including Australia, the USA, the UK, Hong Kong, Canada, Singapore, Japan, New Zealand, Thailand, Colombia and Uruguay were interviewed from April 2017 to November 2019.

Results

We identified four themes: defining patient suitability (confidence in capacity for self-management, ensuring clinical stability and expected resilience), building endurance (facilitating access to practical support, improving mental well-being, optimising quality of care and training to reduce risk of complications), establishing rapport through effective communications (managing expectations to enhance trust, individualising care and harnessing a multidisciplinary approach) and confronting fear and acknowledging barriers to haemodialysis (preventing crash landing to haemodialysis, facing concerns of losing independence and positive framing of haemodialysis).

Conclusion

Nephrologists reported that technique survival in PD is influenced by patients’ medical circumstances, psychological motivation and positively influenced by the education and support provided by treating clinicians and families. Strategies to enhance patients’ knowledge on PD and communication with patients about technique survival in PD are needed to build trust, set patient expectations of treatment and improve the process of transition off PD.

Immunosuppressant medication behaviours in solid organ transplant recipients: a cross-sectional study from south-central China during COVID-19 reopening period

Por: Zhao · Q. · Dong · L. · Wang · L. · Zhao · H. · Zhu · X. · Zhang · Z. · Liu · J.
Objective

Medication non-adherence to immunosuppressants threatens allograft survival and function maintenance among solid organ transplant (SOT) recipients. This study aimed to investigate the prevalence of immunosuppressant medication non-adherence and associated factors during the COVID-19 reopening period among Chinese SOT recipients.

Design

Cross-sectional study.

Setting

South-central China.

Population

Adult patients who received SOT with functioning graft.

Methods

Sociodemographic questionnaire and scales to measure physical activity, depression and medication non-adherence were used to collect data. Logistic regression analysis was conducted to identify factors associated with medication non-adherence. Mediation and moderated mediation analyses were performed to examine the potential mechanisms influencing medication behaviour during the pandemic reopening period using SPSS PROCESS macro 4.3 software.

Results

A total of 1121 participants were recruited and the prevalence of medication non-adherence was 36.3% in this study. Recipients who were men, had a higher monthly income, lived alone, had received transplantation for a minimum of 3 years, had received COVID-19 vaccination and experienced depressive symptoms exhibited an increased risk of non-adherence. Contrarily, those who engaged in high-intensity physical activity exhibited a decreased risk. Physical activity was negatively associated with medication non-adherence (r=–0.124, p

Conclusion

This study investigated the prevalence of medication non-adherence among SOT recipients during the COVID-19 reopening period in China, its associated factors and a potential mechanism. Depression fully mediated the association between physical activity and medication non-adherence, and COVID-19 vaccination moderated the relationship between physical activity and depression. These findings provide some insights for managing medication behaviour when confronting public health emergencies. However, relationships displayed in the moderated mediation model should be tracked after returning to normal life and other potential relationships should be explored to deeply understand medication non-adherent behaviour.

Combined MRI-TRUS fusion targeted and systematic biopsy versus systematic biopsy alone for the detection of prostate cancer: protocol for a prospective single-centre trial

Por: Liu · W. · Kadier · A. · Shen · D. · He · Y. · Dong · S. · Zhu · K. · Xu · G. · Zhao · B. · Mao · S. · Guo · C. · Yao · X. · Wei · Q. · Han · D. · Yang · B.
Introduction

The classic way of diagnosing prostate cancer (PCa) is by conducting the 12-core systematic biopsy (SB). However, it has a low detection rate for clinically significant PCa (csPCa) and can lead to the detection of clinically insignificant PCa (cisPCa). Although MRI-transrectal ultrasound (MRI-TRUS) fusion targeted biopsy (TB) can effectively improve the detection rate of csPCa, it may still miss some cases. Therefore, we propose using a combination of TB and SB methods to enhance the detection rate of csPCa while minimising the detection rate of cisPCa.

Methods and analysis

This study is a prospective, single-centre investigation that aims to assess and compare the detection rate of csPCa using MRI-TRUS fusion TB combined with SB versus TRUS 12-core SB alone. Biopsy-naïve men with suspected PCa will be subjected to multiparametric MRI. Patients with Prostate Imaging Reporting and Data System (V.2.1) score ≥3 will be enrolled in the TB-SB combination group. The sample size is established as 660 participants, considering a 10% drop-out rate. The primary outcome is the detection rate of csPCa in men without prior biopsy using MRI-TRUS fusion TB combined with the standard TRUS-guided 12-core SB method. CsPCa will be defined as International Society of Urological Pathology Grade ≥2.

Ethics and dissemination

This study has been approved by the Ethics Committee at the Shanghai Tenth People’s Hospital, an affiliated hospital of Tongji University School of Medicine. The research results will be published in a peer-reviewed international journal.

Trial registration number

ChiCTR2000036089.

Role of HDL cholesterol in anthracycline-induced subclinical cardiotoxicity: a prospective observational study in patients with diffuse large B-cell lymphoma treated with R-CHOP

Por: Ou · W. · Jiang · T. · Zhang · N. · Lu · K. · Weng · Y. · Zhou · X. · Wang · D. · Dong · Q. · Tang · X.
Objectives

Anthracycline-induced cardiotoxicity is a debilitating cardiac dysfunction for which there are no effective treatments, making early prevention of anthracycline-induced subclinical cardiotoxicity (AISC) crucial. High-density lipoprotein cholesterol (HDL-C) plays a role in cardioprotection, but its impact on AISC remains unclear. Our study aims to elucidate the protective capacity of HDL-C in AISC in patients with diffuse large B-cell lymphoma (DLBCL) treated with R-CHOP (cyclophosphamide, vincristine, doxorubicin, prednisone and rituximab).

Design

Prospective observational study.

Setting

Conducted in China from September 2020 to September 2022.

Participants

70 chemotherapy-naïve patients newly diagnosed with DLBCL who were scheduled to receive the standard dose of R-CHOP; 60 participants included in a case–control study (DOI: 10.1186/s12885-022-10085-6).

Primary outcome measures

Serum biomarkers, 2D speckle tracking echocardiography and conventional echocardiography were measured at baseline, at the end of the third and sixth cycles of R-CHOP and 6 and 12 months after chemotherapy.

Results

24 patients experienced AISC, while 10 did not. 36 patients were lost to follow-up and death. Cox regression analysis showed that higher levels of HDL-C were associated with a significantly lower risk of AISC (unadjusted HR=0.24, 95% CI 0.09 to 0.67, p=0.006; adjusted HR=0.27, 95% CI 0.09 to 0.79, p=0.017). Patients without AISC had a more stable and higher HDL-C level during the follow-up period. HDL-C levels significantly decreased from the end of the third cycle of chemotherapy to the end of the sixth cycle of chemotherapy in all patients (p=0.034), and particularly in the AISC group (p=0.003). The highest level of HDL-C was significantly higher in patients without AISC than in those with AISC (1.52±0.49 vs 1.22±0.29, p=0.034).

Conclusions

Our study suggests that higher HDL-C levels may associate with lower AISC risk in patients with DLBCL treated with R-CHOP. HDL-C could be a cardioprotective target, but further research is needed to confirm its benefits and limitations.

Study registration number

Study registration number: ChiCTR2100054721

Can an integrated intervention package including peer support increase the proportion of health facility births? A cluster randomised controlled trial in Northern Uganda

Por: Nankabirwa · V. · Mukunya · D. · Ndeezi · G. · Odongkara · B. · Arach · A. A. · Achora · V. · Mugenyi · L. · Sebit · M. B. · Wandabwa · J. N. · Waako · P. · Tylleskär · T. · Tumwine · J. K.
Objective

To assess the effect of an integrated intervention package compared with routine government health services on the frequency of health facility births.

Setting

Three subcounties of Lira district in Northern Uganda.

Design

A cluster randomised controlled trial where a total of 30 clusters were randomised in a ratio of 1:1 to intervention or standard of care.

Participants

Pregnant women at ≥28 weeks of gestation.

Interventions

Participants in the intervention arm received an integrated intervention package of peer support, mobile phone messaging and birthing kits during pregnancy while those in the control arm received routine government health services (‘standard of care’).

Primary and secondary outcome measures

The primary outcome was the proportion of women giving birth at a health facility in the intervention arm compared with the control arm. Secondary outcomes were perinatal and neonatal deaths.

Results

In 2018–2019, 995 pregnant women were included in 15 intervention clusters and 882 in 15 control clusters. The primary outcome was ascertained for all except one participant who died before childbirth. In the intervention arm, 754/994 participants (76%) gave birth at a health facility compared with 500/882 (57%) in the control arm. Participants in the intervention arm were 35% more likely to give birth at a health facility compared with participants in the control arm, (risk ratio 1.35 (95% CI 1.20 to 1.51)) and (risk difference 0.20 (95% CI 0.13 to 0.27)). Adjusting for baseline differences generated similar results. There was no difference in secondary outcomes (perinatal or neonatal mortality or number of postnatal visits) between arms.

Conclusion

The intervention was successful in increasing the proportion of facility-based births but did not reduce perinatal or neonatal mortality.

Trial registration number

NCT02605369

Quantitative assessments of retinal macular structure among rural-dwelling older adults in China: a population-based, cross-sectional, optical coherence tomography study

Por: Zhang · Q. · Zhang · C. · Wang · Y. · Cong · L. · Liu · K. · Xu · Z. · Jiang · C. · Zhou · W. · Zhang · C. · Dong · Y. · Feng · J. · Qiu · C. · Du · Y.
Objectives

To quantitatively assess and compare retinal macular structures of rural-dwelling older adults in China using two different optical coherence tomography (OCT) scanners and to examine their associations with demographic, lifestyle, clinical and ocular factors.

Design, setting and participants

This population-based, cross-sectional study included 971 participants (age ≥60 years) derived from the Multimodal Interventions to Delay Dementia and Disability in Rural China study. We collected data on demographics, lifestyle factors, clinical conditions (eg, cardiovascular disease (CVD)) and ocular factors (eg, visual acuity and spherical equivalent). We used two models of spectral-domain OCT to measure macular parameters in nine Early Treatment Diabetic Retinopathy Study subfields. Data were analysed using the multiple general linear models.

Results

Spectralis OCT demonstrated higher macular thickness but a lower macular volume than Primus 200 OCT (p

Conclusions

Macular thickness and volume assessed by Spectralis and Primus 200 OCT scanners differ. Older age and female sex are associated with lower macular thickness and volume. Macular parameters are associated with education, CVD and spherical equivalent.

Trial registeration number

MIND-China study (ChiCTR1800017758).

Microbial interactions among Gardnerella, Prevotella and Fannyhessea prior to incident bacterial vaginosis: protocol for a prospective, observational study

Por: Muzny · C. A. · Elnaggar · J. H. · Sousa · L. G. V. · Lima · A. · Aaron · K. J. · Eastlund · I. C. · Graves · K. J. · Dong · C. · Van Gerwen · O. T. · Luo · M. · Tamhane · A. · Long · D. · Cerca · N. · Taylor · C. M.
Introduction

The aetiology of bacterial vaginosis (BV), a biofilm-associated vaginal infection, remains unknown. Epidemiologic data suggest that it is sexually transmitted. BV is characterised by loss of lactic acid-producing lactobacilli and an increase in facultative and strict anaerobic bacteria. Gardnerella spp are present in 95%–100% of cases; Gardnerella vaginalis has been found to be more virulent than other BV-associated bacteria (BVAB) in vitro. However, G. vaginalis is found in women with normal vaginal microbiota and colonisation is not sufficient for BV development. We hypothesise that Gardnerella spp initiate BV biofilm formation, but incident BV (iBV) requires incorporation of other key BVAB (ie, Prevotella bivia, Fannyhessea vaginae) into the biofilm that alter the transcriptome of the polymicrobial consortium. This study will investigate the sequence of microbiologic events preceding iBV.

Methods and analysis

This study will enrol 150 women aged 18–45 years with normal vaginal microbiota and no sexually transmitted infections at a sexual health research clinic in Birmingham, Alabama. Women will self-collect twice daily vaginal specimens up to 60 days. A combination of 16S rRNA gene sequencing, qPCR for Gardnerella spp, P. bivia and F. vaginae, and broad range 16S rRNA gene qPCR will be performed on twice daily vaginal specimens from women with iBV (Nugent score 7–10 on at least 2 consecutive days) and controls (with comparable age, race, contraceptive method and menstrual cycle days) maintaining normal vaginal microbiota to investigate changes in the vaginal microbiota over time for women with iBV. Participants will complete daily diaries on multiple factors including sexual activity.

Ethics and dissemination

This protocol is approved by the University of Alabama at Birmingham Institutional Review Board (IRB-300004547) and written informed consent will be obtained from all participants. Findings will be presented at scientific conferences and published in peer-reviewed journals as well as disseminated to providers and patients in communities of interest.

Barriers to uptake of cataract surgery among elderly patients in rural China: a cross-sectional study

Por: Ma · X. · Hao · J. · Jan · C. · Wan · Y. · Xie · Y. · Liu · C. · Shi · Y. · Hu · A. · Cao · K. · Congdon · N. · Rozelle · S. · Dong · Z. · Wang · N.
Objective

To investigate factors that differentiate elderly adults in rural China who accept free vision screening and cataract surgery from those who could benefit from vision care but refuse it when offered.

Design

We conducted a population-based, cross-sectional study between October and December 2016. Logistic regression models were used to examine the predictors of accepting free vision screening and cataract surgery.

Setting

Rural communities in Handan, China.

Participants

Adults aged 50 years or older, with presenting visual acuity ≤6/18 in the better seeing eye, suspected by examining ophthalmologist to be due to cataract.

Results

Among 613 persons with cataract identified on a population basis, 596 (97.2%) completed the household survey (mean (SD) age, 71.5 (10.0) years; 79.8% female). A total of 214 persons (35.9%) refused participation, while 382 (64.1%) took part in the vision screening. A total of 193 (50.5%) participants were found eligible for surgery, while 189 (49.5%) were not. Among 99 randomly selected participants who were offered immediate free surgery, surgery was accepted by 77 participants (77.8%) and refused by 22 (22.2%). In the multivariate model, being engaged in income-generating activities (p

Conclusion

Our results suggest that refusal of basic eye examinations may be at least as important a determinant of low surgical rates in rural China as lack of acceptance of surgery itself.

Development and validation of a model to predict mortality risk among extremely preterm infants during the early postnatal period: a multicentre prospective cohort study

Por: Zhang · W.-w. · Wang · S. · Li · Y. · Dong · X. · Zhao · L. · Li · Z. · Liu · Q. · Liu · M. · Zhang · F. · Yao · G. · Zhang · J. · Liu · X. · Liu · G. · Zhang · X. · Reddy · S. · Yu · Y.-h.
Background

Recently, with the rapid development of the perinatal medical system and related life-saving techniques, both the short-term and long-term prognoses of extremely preterm infants (EPIs) have improved significantly. In rapidly industrialising countries like China, the survival rates of EPIs have notably increased due to the swift socioeconomic development. However, there is still a reasonably lower positive response towards the treatment of EPIs than we expected, and the current situation of withdrawing care is an urgent task for perinatal medical practitioners.

Objective

To develop and validate a model that is practicable for EPIs as soon as possible after birth by regression analysis, to assess the risk of mortality and chance of survival.

Methods

This multicentre prospective cohort study used datasets from the Sino-Northern Neonatal Network, including 46 neonatal intensive care units (NICUs). Risk factors including maternal and neonatal variables were collected within 1 hour post-childbirth. The training set consisted of data from 41 NICUs located within the Shandong Province of China, while the validation set included data from 5 NICUs outside Shandong Province. A total of 1363 neonates were included in the study.

Results

Gestational age, birth weight, pH and lactic acid in blood gas analysis within the first hour of birth, moderate-to-severe hypothermia on admission and adequate antenatal corticosteroids were influencing factors for EPIs’ mortality with important predictive ability. The area under the curve values for internal validation of our prediction model and Clinical Risk Index for Babies-II scores were 0.81 and 0.76, and for external validation, 0.80 and 0.51, respectively. Moreover, the Hosmer-Lemeshow test showed that our model has a constant degree of calibration.

Conclusions

There was good predictive accuracy for mortality of EPIs based on influencing factors prenatally and within 1 hour after delivery. Predicting the risk of mortality of EPIs as soon as possible after birth can effectively guide parents to be proactive in treating more EPIs with life-saving value.

Trial registration number

ChiCTR1900025234.

Effects of repetitive transcranial magnetic stimulation over the contralesional dorsal premotor cortex on upper limb function in severe ischaemic stroke: study protocol for a randomised controlled trial

Por: Dai · W. · Yang · X. · Liu · C. · Ding · H. · Guo · C. · Zhu · Y. · Dong · M. · Qian · Y. · Fang · L. · Wang · T. · Shen · Y.
Introduction

Repetitive transcranial magnetic stimulation (rTMS) is an evidence-based treatment widely recommended to promote hand motor recovery after ischaemic stroke. However, the therapeutic efficacy of rTMS over the motor cortex in stroke patients is currently restricted and heterogeneous. This study aimed to determine whether excitatory rTMS over the contralesional dorsal premotor cortex (cPMd) facilitates the functional recovery of the upper limbs during the postacute stage of severe ischaemic stroke.

Methods and analysis

This study will be conducted as a single-blind, controlled, randomised study, in which 44 patients with poststroke hemiplegia with a course of disease ranging from 1 week to 3 months and Fugl-Meyer upper limb score ≤22 will be enrolled. The study participants will be randomly assigned to groups A (n=22) and B (n=22). The two groups are based on routine rehabilitation training and drug treatment; group A will be treated with low-frequency (1 Hz) rTMS over the contralesional primary motor cortex (cM1), and group B will be treated with high-frequency (10 Hz) rTMS over cPMd. For 2 weeks, rTMS will be administered once a day, 5 days a week. The primary outcome is the Fugl-Meyer assessment of the upper limb. The secondary outcomes include the Arm Subscore of the Motricity Index, Hong Kong edition of Functional Test for the Hemiplegic Upper Extremity, Modified Barthel Index and Modified Ashworth Scale score of the paralysed pectoralis major and biceps brachii. Furthermore, data of diffusion tensor imaging and functional MRI will be collected. These outcomes will be assessed before and after the completion of the intervention.

Ethics and dissemination

This study has been approved by the Ethics Committee of the First Affiliated Hospital of Nanjing Medical University (2020 SR-266). The findings of this study will be spread through networks of scientists, professionals and the general public as well as peer-reviewed scientific papers and presentations at pertinent conferences.

Trial registration number

ChiCTR2000038049

Experiences and perspectives of healthcare professionals, patients and caregivers toward the serious illness conversation guide: protocol for a qualitative meta-synthesis

Por: Yang · L. · Zhu · N. · Wang · X. · Tan · J. · Chen · L. · Su · C. · Dong · T. · Long · B. · Qiu · Y. · Deng · R.
Introduction

Exploring the experiences and perspectives of healthcare professionals, patients and caregivers toward serious illness conversations based on the Serious Illness Care Program is vital for improving communication with patients who are seriously ill, as has been shown in previous studies. However, few studies have carried out a systematic review to examine common themes, strengthen conclusions and identify gaps in the literature, the findings of which could help steer further research, policies and practice to improve more timely and person-centred conversations about the values and priorities of patients with serious illnesses. The objective of this qualitative meta-synthesis is to explore how healthcare professionals, patients and caregivers described their own experiences of the processes of serious illness communication through a secondary analysis of published qualitative data.

Methods and analysis

Meta-aggregation will be used to conduct a systematic review of qualitative studies. We conducted an initial search on 10 October 2023; papers published in English will be searched using electronic databases, including PubMed (MEDLINE), Web of Science, Embase, Ovid and CINAHL. Studies that satisfy the eligibility criteria will be evaluated for methodological quality using the Joanna Briggs Institute (JBI) Critical Appraisal Checklist for Qualitative Research. The meta-aggregative review will consist of the following: (1) extraction of findings of all included studies; (2) categorisation of the findings, with at least two findings per category; and (3) synthesis of one or more findings from at least two categories. Study eligibility screening, data extraction, analysis and JBI Critical Appraisal Checklist and Grading of Recommendations Assessment, Development and Evaluation-Confidence in the Evidence from Reviews of Qualitative research assessments will be undertaken independently by two authors.

Ethics and dissemination

Secondary data analysis of published literature does not require ethical approval. The results will be disseminated in peer-reviewed journals and presented in conference papers and elsewhere.

PROSPERO registration number

CRD42022330859.

Protocol for SNOTOB study: radical prostatectomy without prostate biopsy following 18F-PSMA-1007 PET/CT based on a diagnostic model: a single-centre, single-arm, open-label study

Por: Wang · C. · Dong · Q. · Liu · X. · Ni · M. · Xie · Q. · Xiao · J. · Tao · T.
Introduction

Nowadays, invasive prostate biopsy is the standard diagnostic test for patients with suspected prostate cancer (PCa). However, it has some shortcomings such as perioperative complications, economic and psychological burden on patients, and some patients may undergo repeated prostate biopsy. In this study protocol, our aim is to provide a non-invasive diagnostic strategy we call the ‘prostate-specific membrane antigen (PSMA) combined model’ for the diagnosis of PCa. If patients are diagnosed with PCa using PSMA combined model, we want to prove these patients can receive radical prostatectomy directly without prior prostate biopsies.

Methods

The SNOTOB trial adopts a prospective, single-centre, single-arm, open-label study design. The PSMA combined model consists of a diagnostic model based on what we previously reported and 18F-PSMA-1007 positron emission tomography/CT (18F-PSMA-1007 PET/CT) examinations in series. First, patients use the diagnostic model (online address: https://ustcprostatecancerprediction.shinyapps.io/dynnomapp/) to calculate the risk probability of clinically significant PCa (csPCa). When the risk probability of csPCa is equal or greater than 0.60, 18F-PSMA-1007 PET/CT will be applied for further diagnosis. If patients are still considered as csPCa after 18F-PSMA-1007 PET/CT examinations, we define this condition as positive results of PSMA combined model. Subsequently, we will recommend these patients to accept radical prostatectomy without prostate biopsy directly. Finally, the diagnostic performance of PSMA combined model will be verified with the pathological results. Totally, 57 patients need to be enrolled in this clinical trial.

Ethics and dissemination

This study was approved by the ethics committee of The First Affiliated Hospital of USTC (No. 2022KY-142). The results of this study will be published in peer-reviewed journals and reported at academic conferences.

Trial registration number

NCT05587192.

Sinus node dysfunction and stroke risk: a systematic review and meta-analysis

Por: Dong · H. · Chen · H. · Hidru · T. H. · Xia · Y. · Yang · X.
Objectives

The role of cardiac arrhythmia in ischaemic stroke is widely studied, but the size of the stroke risk in patients with sinus node dysfunction (SND) with and without atrial fibrillation (AF) is unclear. This systematic review and meta-analysis aimed to compare the risk of stroke and its associated factors in patients with SND with and without AF.

Design

A systematic review and meta-analysis was conducted based on the Grading of Recommendations, Assessment, Development and Evaluation approach.

Data sources

PubMed, EMBASE and Cochrane Database were searched until December 2022.

Eligibility criteria for selecting studies

Studies that investigate stroke in patients with SND diagnosed with or without AF/atrial flutter.

Data extraction and synthesis

Two independent authors screened studies for inclusion and extracted data. Literature quality assessment was performed using the Newcastle-Ottawa Scale and the Cochrane Collaboration Tool. The overall risk of stroke was estimated using the random-effects model. The generic inverse variance method was used to calculate the pooled estimates of stroke-associated factors. We performed a sensitivity analysis using a fixed-effects model.

Results

Of the 929 records retrieved, 6 papers (106 163 patients) met the inclusion criteria. The average yearly stroke incidence in patients with SND was 1.542% (95% CI: 1.334% to 1.749%). The stroke incidence was similar between the isolated SND (1.587%; 95% CI: 1.510% to 1.664%) and non-isolated (SND+AF) (1.660%; 95% CI: 0.705% to 2.615%) groups. AF (HR, 95% CI: 1.53 (1.01 to 2.33)), stroke/transient ischaemia attack/other thrombotic events (HR, 95% CI: 2.54 (1.14 to 5.69)), hypertension (HR, 95% CI: 1.51 (1.11 to 2.07)) and heart failure (HR, 95% CI: 1.41 (1.01 to 1.97)) were associated with stroke in the SND population.

Conclusion

Our findings suggest that patients with SND carry a similar risk of stroke to those with combined SND and AF. Future studies are needed to investigate whether interventions targeting stroke prevention, such as anticoagulation therapy, can help to prevent stroke in patients with SND.

PROSPERO registration number

CRD42023408436.

Relationship between diabetic knowledge, attitudes and practices among patients with diabetes in China: a structural equation model

Por: Zhu · W. · Liang · D. · Petersen · J. D. · Zhang · W. · Huang · J. · Dong · Y.
Objectives

Whether the routine delivery of diabetes-related knowledge can change patients’ attitudes and hence influence their self-management activities remains unknown in primary healthcare settings in China. Thus, this study aims to explore the complex transformation process between knowledge, attitude and practice (KAP) among patients with diabetes in a city in China.

Design

A cross-sectional study.

Setting

Yuhuan City, Zhejiang Province, China.

Participants

A total of 803 patients with diabetes were invited to attend a questionnaire survey and 782 patients with type 2 diabetes completed the survey. The average age of participants was 58.47 years old, 48.21% of whom only attended primary school or below.

Primary and secondary outcome measures

A questionnaire based on existing scales and expert consultation was applied to assess patients’ socio-demographic information (SI), disease progression risk and diabetes-related KAP. A structural equation model was built to analyse the relationships between patients’ characteristics and KAP.

Results

No significant association was found between patients’ knowledge and attitude (β=0.01, p=0.43). Better knowledge and attitude were both found to be associated with better diet and physical activities (β=0.58, p

Conclusions

While successful KAP transformation has been achieved in practice for diet and physical activities, there is a need to improve foot care practice. Health education should also prioritise the prevention, detection and care of diabetic foot. Also, appropriate methods should be adopted to deliver health education to vulnerable patients, such as the elderly, those living in rural areas, those with minimal education, the unemployed and low-income patients.

Design and rationale of the ATTRACTIVE trial: a randomised trial of intrAThrombus Thrombolysis versus aspiRAtion thrombeCTomy during prImary percutaneous coronary interVEntion in ST-segment elevation myocardial infarction patients with high thrombus burde

Por: Zhang · Z. · Sheng · Z. · Che · W. · An · S. · Sun · D. · Zhai · Z. · Zhao · X. · Yang · Y. · Meng · Z. · Ye · Z. · Xie · E. · Li · P. · Yu · C. · Gao · Y. · Xiao · Z. · Wu · Y. · Dong · F. · Ren · J. · Zheng · J.
Introduction

ST-segment elevation myocardial infarction (STEMI) with high thrombus burden is associated with a poor prognosis. Manual aspiration thrombectomy reduces coronary vessel distal embolisation, improves microvascular perfusion and reduces cardiovascular deaths, but it promotes more strokes and transient ischaemic attacks in the subgroup with high thrombus burden. Intrathrombus thrombolysis (ie, the local delivery of thrombolytics into the coronary thrombus) is a recently proposed treatment approach that theoretically reduces thrombus volume and the risk of microvascular dysfunction. However, the safety and efficacy of intrathrombus thrombolysis lack sufficient clinical evidence.

Methods and analysis

The intrAThrombus Thrombolysis versus aspiRAtion thrombeCTomy during prImary percutaneous coronary interVEntion trial is a multicentre, prospective, open-label, randomised controlled trial with the blinded assessment of outcomes. A total of 2500 STEMI patients with high thrombus burden who undergo primary percutaneous coronary intervention will be randomised 1:1 to intrathrombus thrombolysis with a pierced balloon or upfront routine manual aspiration thrombectomy. The primary outcome will be the composite of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, heart failure readmission, stent thrombosis and target-vessel revascularisation up to 180 days.

Ethics and dissemination

The trial was approved by Ethics Committees of China-Japan Friendship Hospital (2022-KY-013) and all other participating study centres. The results of this trial will be published in peer-reviewed journals.

Trial registration number

NCT05554588.

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