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Exploring patient perceptions of repetitive transcranial magnetic stimulation as a treatment for chronic musculoskeletal pain: a qualitative study

Por: Stillianesis · G. · Cavaleri · R. · Summers · S. J. · Tang · C.
Objective

Repetitive transcranial magnetic stimulation (rTMS), a form of non-invasive brain stimulation, is a novel avenue for the management of chronic musculoskeletal pain. Despite evidence for the effectiveness of rTMS in chronic pain conditions, the clinical uptake of rTMS remains limited and little is known regarding patient perceptions of this therapeutic technique.

Design

Qualitative study using a phenomenological approach, reported in accordance with the Consolidated criteria for Reporting Qualitative research checklist.

Setting

Sydney, Australia.

Participants

Fifteen participants were recruited from the community and completed the study. All participants had a diagnosis of chronic musculoskeletal pain, a history of seeking treatment and no prior experience with rTMS.

Methods and analysis

All participants completed a semistructured interview to explore overall knowledge, preconceived concerns and attitudes regarding rTMS as a treatment for chronic musculoskeletal pain. The interviews were transcribed verbatim and analysed thematically.

Results

The key themes that influenced an individual’s hypothetical acceptance of rTMS for chronic pain management were (1) the individual’s initial impression of the equipment appearance, (2) the participant’s individual history and familiarity with technology, (3) the accessibility and availability of rTMS and (4) knowledge regarding pain physiology and rTMS.

Conclusions

This was the first qualitative study to explore the perception of rTMS as a treatment among people with chronic musculoskeletal pain. RTMS appears to be accepted as a treatment option among individuals with chronic musculoskeletal pain. Developing targeted strategies to address accessibility, funding support and medical endorsements may encourage use of rTMS in a clinical chronic pain setting.

Effects of subanaesthetic S-ketamine on postoperative delirium and cognitive function in elderly patients undergoing non-cardiac thoracic surgery: a protocol for a randomised, double-blinded, placebo-controlled and positive-controlled, non-inferiority tri

Por: Wei · W. · Zhang · A. · Liu · L. · Zheng · X. · Tang · C. · Zhou · M. · Gu · Y. · Yao · Y.
Introduction

Postoperative delirium (POD) is a common and distressing complication after thoracic surgery. S-ketamine has neuroprotective properties as a dissociative anaesthetic. Emerging literature has indicated that S-ketamine can reduce cognitive impairment in patients with depression. However, the role of S-ketamine in preventing POD remains unknown. Therefore, this study aims to evaluate the effect of intraoperative prophylactic S-ketamine compared with that of dexmedetomidine on the incidence of POD in elderly patients undergoing non-cardiac thoracic surgery.

Methods and analysis

This will be a randomised, double-blinded, placebo-controlled, positive-controlled, non-inferiority trial that enrolled patients aged 60–90 years undergoing thoracic surgery. The patients will be randomly allocated in a ratio of 1:1:1 to S-ketamine, dexmedetomidine or normal saline placebo groups using computer-generated randomisation with a block size of six. The primary outcome will be the incidence of POD within 4 days after surgery and this will be assessed using a 3-Minute Diagnostic Confusion Assessment Method two times per day. The severity and duration of POD, the incidence of emergence delirium, postoperative pain, quality of sleep, cognitive function, and the plasma concentrations of acetylcholine, brain-derived neurotrophic factor, tumour necrosis factor-α and incidence of adverse events will be evaluated as secondary outcomes.

Ethics and dissemination

Ethical approval has been obtained from the Institutional Review Board of the Cancer Hospital and the Institute of Guangzhou Medical University (ZN202119). At the end of the trial, we commit to making a public disclosure available, regardless of the outcome. The public disclosure will include a publication in an appropriate journal and an oral presentation at academic meetings.

Trial registration number

ChiCTR2100052750 (NCT05242692).

Changes in miroRNA‐103 expression in wound margin tissue are related to wound healing of diabetes foot ulcers

Abstract

To investigate the relationship between small noncoding microRNA-103 (miR-103) and wound healing of diabetic foot ulcers (DFU) and the underlying molecular mechanism, forty type 2 diabetes mellitus with DFU (DFU group), and 20 patients with a chronic skin ulcer of lower limbs and normal glucose tolerance (SUC group) were included. Quantitative real-time PCR method was used to determine miR-103 expression levels in the wound margin tissue of subjects, and to analyse the relationship between the expression of miR-103 and DFU wound healing. In vitro experiments were also performed to understand the effect of miR-103 on the high glucose-induced injury of normal human dermal fibroblasts (NHDFs) cells. The results showed that the miR-103 expression level in the DFU group was significantly higher than that in the SUC group [5.81 (2.25–9.36) vs 2.08 (1.15–5.72)] (P < 0.05). The expression level of miR-103 in the wound margin tissue of DFU was negatively correlated with the healing rate of foot ulcers after four weeks (P = 0.037). In vitro experiments revealed that miR-103 could inhibit the proliferation and migration of NHDF cells and promote the apoptosis of NHDF cells by targeted regulation of regulator of calcineurin 1 (RCAN1) gene expression in a high glucose environment. Down-regulation of miR-103 could alleviate high glucose-induced NHDF cell injury by promoting RCAN1 expression. Therefore, the increased expression of miR-103 is involved in the functional damage of NHDF cells induced by high-glucose conditions, which is related to poor wound healing of DFU. These research findings will provide potential targets for the diagnosis and treatment of chronic skin wounds in diabetes.

Risk factors for foot ulcer recurrence in patients with comorbid diabetic foot osteomyelitis and diabetic nephropathy: A 3‐year follow‐up study

Abstract

This study aimed to explore the risk factors for foot ulcer recurrence in patients with comorbid diabetic foot osteomyelitis (DFO) and diabetic nephropathy (DN). This is a prospective cohort study. Between May 2018 and May 2021, we selected 120 inpatients with comorbid severe diabetic foot infection (PEDIS Grade 3 or above) and DN for inclusion in our study. All cases were followed up for 36 months. The study outcomes were whether foot ulcer recurred and the time to recurrence. The risk factors of ulcer recurrence were analysed by comparing the data of the three groups. According to the recurrence of foot ulcer, the participants were divided into three groups: Group A (no foot ulcer recurrence, n = 89), Group B (foot ulcer recurrence within 12-36 months, n = 19) and Group C (foot ulcer recurrence within 6-12 months, n = 12). The multivariate Cox regression analysis showed that urine albumin-creatinine ratio (UACR) (HR: 1.008, 95% CI: 1.005-1.011, P < .001) and vibration perception threshold (VPT) (HR: 1.064, 95% CI: 1.032-1.096, P < .001) were identified as independent risk factors. Kaplan-Meier curves showed a significant positive association between UACR or VPT and the risk of foot ulcer recurrence (log rank, all P < .05). Areas under the ROC curves for UACR, VPT and the combination of UACR and VPT were 0.802, 0.799 and 0.842, respectively. The best cut-off values of UACR and VPT were 281.51 mg/g and 25.12 V, respectively. In summary, elevated UACR and VPT were independent risk factors. The best clinical cut-off values of UACR and VPT for prediction of foot ulcer recurrence were 281.51 mg/g and 25.12 V, respectively. Besides, our results suggested that microcirculation disorders rather than macrovascular complications play a major role in the recurrence of foot ulcer in patients with comorbid DFO and DN.

Association between vitamin D deficiency and diabetic foot ulcer wound in diabetic subjects: A meta‐analysis

Abstract

A meta-analysis was performed to evaluate the association between vitamin D deficiency and diabetic foot ulcer wounds in diabetic subjects. A systematic literature search up to March 2022 incorporated 7586 subjects with diabetes mellitus at the beginning of the study; 1565 were using diabetic subjects with foot ulcer wounds, and 6021 were non-ulcerated diabetic subjects. Statistical tools like the dichotomous and contentious method were used within a random or fixed-influence model to establish the odds ratio (OR) and mean difference (MD) with 95% confidence intervals (CIs) to evaluate the influence of vitamin D deficiency in managing diabetic foot ulcer wound. Diabetic subjects with foot ulcer wounds had significantly lower vitamin D levels (MD, −6.48; 95% CI, −10.84 to −2.11, P < .004), higher prevalence of vitamin D deficiency (<50 nmoL/L) (OR, 1.82; 95% CI, 1.32-2.52, P < .001), and higher prevalence of severe vitamin D deficiency (OR, 2.53; 95% CI, 1.65-3.89, P < .001) compared with non-ulcerated diabetic subjects. Diabetic subjects with foot ulcer wounds had significantly lower vitamin D levels, higher prevalence of vitamin D deficiency, and higher prevalence of severe vitamin D deficiency compared with non-ulcerated diabetic subjects. Further studies are required to validate these findings.

Evidence mapping and overview of systematic reviews of the effects of acupuncture therapies

Por: Lu · L. · Zhang · Y. · Ge · S. · Wen · H. · Tang · X. · Zeng · J. c. · Wang · L. · Zeng · Z. · Rada · G. · Avila · C. · Vergara · C. · Chen · R. · Dong · Y. · Wei · X. · Luo · W. · Wang · L. · Guyatt · G. · Tang · C.-Z. · Xu · N.-G.
Objective

To provide a route map regarding systematic reviews (SRs) of acupuncture therapies that will meet two goals: (1) to identify areas in which more or better evidence is required and (2) to identify acupuncture applications that, although proven effective, remain underused in practice, and thus warrant more effective knowledge dissemination.

Eligibility criteria

We included SRs that conducted meta-analyses (MAs) of randomised controlled trials (RCTs) for this overview.

Information sources

We searched for SRs without language restrictions from January 2015 to November 2020 in four Chinese electronic databases and Epistemonikos database. And we also searched for newly published RCTs that were eligible for selected best SRs in PubMed, Medline, Cochrane Central Register of Controlled Trials, Embase and four Chinese electronic databases from its lasted search dates to November 2020.

Synthesis of results

We reanalysed the selected MAs if new primary studies were added. We used random-effect model to calculate the overall effect.

Results

Our search identified 120 SRs published in the last 5 years addressing acupuncture therapies across 12 therapeutic areas and 77 diseases and conditions. The SRs included 205 outcomes and involved 138 995 participants from 1402 RCTs. We constructed 77 evidence matrices, including 120 SRs and their included RCTs in the Epistemonikos database. Seventy-seven SRs represented the effect estimate of acupuncture therapies. Finally, we system summarised the areas of possible underutilisation of acupuncture therapies (high or moderate certainty evidence of large or moderate effects), and the areas of warranting additional investigation of acupuncture therapies (low or very low certainty evidence of moderate or large effects).

Conclusion

The evidence maps and overview of SRs on acupuncture therapies identified both therapies with substantial benefits that may require more assertive evidence dissemination and promising acupuncture therapies that require further investigation.

Weight loss for overweight and obese patients with prostate cancer: a study protocol of a randomised trial comparing clinic-based versus Telehealth delivered EXercise and nutrition intervention (the TelEX trial)

Por: Galvao · D. A. · Taaffe · D. R. · Hayne · D. · Lopez · P. · Lyons-Wall · P. · Tang · C. I. · Chambers · S. K. · Devine · A. · Spry · N. · Jeffery · E. · Kudiarasu · C. · Joseph · D. · Newton · R. U.
Introduction

Obese men with prostate cancer have an increased risk of biochemical recurrence, metastatic disease and mortality. For those undergoing androgen deprivation therapy (ADT), substantial increases in fat mass are observed in the first year of treatment. Recently, we showed that a targeted supervised clinic-based exercise and nutrition intervention can result in a substantial reduction in fat mass with muscle mass preserved in ADT-treated patients. However, the intervention needs to be accessible to all patients and not just those who can access a supervised clinic-based programme. The purpose of this study was to evaluate the efficacy of telehealth delivered compared with supervised clinic-based delivered exercise and nutrition intervention in overweight/obese patients with prostate cancer.

Methods and analysis

A single-blinded, two-arm parallel group, non-inferiority randomised trial will be undertaken with 104 overweight/obese men with prostate cancer (body fat percentage ≥25%) randomly allocated in a ratio of 1:1 to a telehealth-delivered, virtually supervised exercise and nutrition programme or a clinic-based, face-to-face supervised exercise and nutrition programme. Exercise will consist of supervised resistance and aerobic exercise performed three times a week plus additional self-directed aerobic exercise performed 4 days/week for the first 6 months. Thereafter, for months 7–12, the programmes will be self-managed. The primary endpoint will be fat mass. Secondary endpoints include lean mass and abdominal aortic calcification, anthropometric measures and blood pressure assessment, objective measures of physical function and physical activity levels, patient-reported outcomes and blood markers. Measurements will be undertaken at baseline, 6 months (post intervention), and at 12 months of follow-up. Data will be analysed using intention-to-treat and per protocol approaches.

Ethics and dissemination

Ethics approval has been obtained from the Edith Cowan University Human Research Ethics Committee (ID: 2021–02157-GALVAO). Outcomes from the study will be published in academic journals and presented in scientific and consumer meetings.

Trial registration number

ACTRN12621001312831.

Development and validation of a social vulnerabilities survey for medical inpatients

Por: Tang · K. L. · Sajobi · T. · Santana · M.-J. · Lawal · O. · Tesorero · L. · Ghali · W. A.
Objectives

Our objective was to validate a Social Vulnerabilities Survey that was developed to identify patient barriers in the following domains: (1) salience or priority of health; (2) social support; (3) transportation; and (4) finances.

Design

Cross-sectional psychometric study.

Questions for one domain (health salience) were developed de novo while questions for the other domains were derived from national surveys and/or previously validated questionnaires. We tested construct (ie, convergent and discriminative) validity for these new questions through hypothesis testing of correlations between question responses and patient characteristics. Exploratory factor analysis was conducted to determine structural validity of the survey as a whole.

Setting

Patients admitted to the inpatient internal medicine service at a tertiary care hospital in Calgary, Canada.

Participants

A total of 406 patients were included in the study.

Results

The mean age of respondents was 55.5 (SD 18.6) years, with the majority being men (55.4%). In feasibility testing of the first 107 patients, the Social Vulnerabilities Survey was felt to be acceptable, comprehensive and met face validity. Hypothesis testing of the health salience questions revealed that the majority of observed correlations were exactly as predicted. Exploratory factor analysis of the global survey revealed the presence of five factors (eigenvalue >1): social support, health salience, drug insurance, transportation barriers and drug costs. All but four questions loaded to these five factors.

Conclusions

The Social Vulnerabilities Survey has face, construct and structural validity. It can be used to measure modifiable social vulnerabilities, such that their effects on health outcomes can be explored and understood.

Health systems analysis and evaluation of the barriers to availability, utilisation and readiness of sexual and reproductive health services in COVID-19-affected areas: a WHO mixed-methods study protocol

Por: Kouanda · S. · Nahyuha Chomi · E. · Kim · C. · Jen · S. · Bahamondes · L. · Cecatti · J. G. · Lumbiganon · P. · Emefa · M. · Brizuela · V. · Kuganantham · H. · Seuc · A. H. · Ali · M. · WHO HRP Social Science Research Team · Bahamondes · Cecatti · Chomi · Kouanda · Tang · Zhang · Zhu
Introduction

COVID-19 has led to an unprecedented increase in demand on health systems to care for people infected, necessitating the allocation of significant resources, especially medical resources, towards the response. This, compounded by the restrictions on movement instituted may have led to disruptions in the provision of essential services, including sexual and reproductive health (SRH) services. This study aims to assess the availability of contraception, comprehensive abortion care, sexually transmitted infection prevention and treatment and sexual and gender-based violence care and support services in local health facilities during COVID-19 pandemic. This is a standardised generic protocol designed for use across different global settings.

Methods and analysis

This study adopts both quantitative and qualitative methods to assess health facilities’ SRH service availability and readiness, and clients’ and providers’ perceptions of the availability and readiness of these services in COVID-19-affected areas. The study has two levels: (1) perceptions of clients (and the partners) and healthcare providers, using qualitative methods, and (2) assessment of infrastructure availability and readiness to provide SRH services through reviews, facility service statistics for clients and a qualitative survey for healthcare provider perspectives. The health system assessment will use a cross-sectional panel survey design with two data collection points to capture changes in SRH services availability as a result of the COVID-19 epidemic. Data will be collected using focus group discussions, in-depth interviews and a health facility assessment survey.

Ethics and dissemination

Ethical approval for this study was obtained from the WHO Scientific and Ethics Review Committee (protocol ID CERC.0103). Each study site is required to obtain the necessary ethical and regulatory approvals that are required in each specific country.

Maintenance of physical activity after cardiac rehabilitation (FAIR): study protocol for a feasibility trial

Por: Andersen · R. M. · Skou · S. T. · Clausen · M. B. · Jäger · M. · Zangger · G. · Grontved · A. · Brond · J. C. · Soja · A. M. B. · Tang · L. H.
Introduction

To enhance health and prevent secondary consequences for patients with cardiovascular disease (CVD), maintenance of an active lifestyle following participation in cardiac rehabilitation (CR) is important. However, levels of physical activity often decrease after completion of a structured CR programme. Models that support long-term behaviour change with a sustained level of physical activity are imperative. The aim of this study is to evaluate the feasibility of a mobile health intervention based on the Health Action Process Approach theoretical model of behaviour change in patients with CVD for 3 months after completion of a CR programme.

Methods and analysis

In a feasibility trial design, we will recruit 40 participants from CR programmes at Slagelse Hospital, the City of Slagelse (municipality), or Holbæk Hospital. After completing the standard structured CR programme, each participant will create an action plan for physical activity together with a physiotherapist. Following that, participants are sent 2 weekly text messages for 3 months. The first text message prompts physical activity, and the second will check if the action plan has been followed. If requested by participants, a coordinator will call and guide the physical activities behaviour. The feasibility of this maintenance intervention is evaluated based on predefined progression criteria. Physical activity is measured with accelerometers at baseline and at 3 months follow-up.

Ethics and dissemination

Study approval was waived (EMN-2021-00020) by the Research Ethics Committee of Region Zealand, Denmark. Study results will be made public and findings disseminated to patients, health professionals, decision-makers, researchers and the public.

Trial registration number

NCT05011994.

Safety and efficacy of human umbilical cord mesenchymal stem cells for the treatment of sepsis induced by pneumonia: study protocol for a single-centre, randomised single-blind parallel group trial

Por: Wang · C. · Zhao · D. · Zheng · L. · Bao · X. · Yang · Q. · Jiang · S. · Zhou · X. · Tang · L. · Liu · Z.
Introduction

Sepsis is a life-threatening organ disorder caused by a dysregulated inflammatory response to infection with no effective treatment options exist thus far. Therefore, novel therapeutic methods are urgently advocated for decreasing the high mortality rate. Recently, preclinical studies supported the efficacy of mesenchymal stem cells (MSCs) in the treatment of sepsis. In this study, we aim to test the safety, tolerability and efficacy of human umbilical cord MSCs (HUC-MSCs) for the treatment of pneumonia induced sepsis.

Methods and analysis

This study is a single-centre, randomised single-blind parallel group, placebo-controlled trial. Forty eligible participants with pneumonia-induced sepsis will be randomly assigned to the observational cohort and the interventional cohort in a 1:1 ratio. In addition to the standard treatments recommended by the Sepsis 3.0 guidelines, HUC-MSCs will be administered intravenously as adjunctive therapy on day 0 at a dose of 1x106 cells/kg with a total volume of 100 mL diluted with normal saline through 120 mL/hour intravenous central line infusion in the interventional cohort. Placebo (normal saline) will also be administered through 120 mL/hour intravenous central line infusion at the same quantity (total volume of 100 mL) in the observational cohort. The study is approved by Research Ethics Board of East Hospital/Tongji University, which has been registered on Chinese clinical trial registry (chictr.org.cn) and initiated from October 2021. All the participants will be followed at regular intervals for 1 year. Funding is from the ‘National Natural Science Foundation, China and top-level clinical discipline project of Shanghai Pudong’. This study is the first trial to assess the safety and efficacy of HUC-MSCs for the treatment of sepsis induced by pneumonia. The results will advance our understanding of the mode of action of HUC-MSCs and will also be critical for the design of future investigation in larger randomised controlled trials in multicentre. These data will offer insight into defining endpoints, key biomarkers and sample size determination.

Ethics and dissemination

This study has been approved by the Research Ethics Board of East Hospital, Tongji University (Shanghai, China), which has accepted responsibility for supervising all aspects of the study (DFSC-2021(CR-04). The results of this study will be presented at both national and international conferences and be considered for publication in a peer-reviewed scientific journal. All the results presented in this study will be of group data, therefore, individual participants will not be identifiable.

Trial registration number

ChiCTR2100050544, the trial is now at the stage of pre-results.

Association of self-reported snoring and hyperuricaemia: a large cross-sectional study in Chongqing, China

Por: Chen · T. · Ding · X. · Tang · W. · Chen · L. · Mao · D. · Song · L. · Lian · X.
Objective

To examine the relationship between self-reported snoring and hyperuricaemia in a large-scale population in Chongqing, China.

Setting

Face-to-face electronic questionnaire survey, physical examination and biological sample testing were conducted in 13 districts of Chongqing. Chongqing is a municipality in southwest China.

Participants

In this study, 23 308 Han ethnicity permanent residents aged 30–79 years were recruited. Individuals missing data were excluded, 22 389 subjects were included in final analysis.

Primary and secondary outcome measures

Serum uric acid (UA) was measured using an oxidase method. Hyperuricaemia was defined as serum UA >420 µmol/L in men and >360 µmol/L in women. Information about self-reported snoring was obtained by questionnaire survey. All participants were divided into ‘no snoring’ ‘snoring occasionally’ and ‘snoring frequently’. Multivariable logistic regression analysis was performed to assess the relationship between self-reported snoring and hyperuricaemia.

Results

The prevalence of hyperuricaemia was 14.43%, and snorers were more likely to have hyperuricaemia than non-snorer in different age and gender groups. For the total population, those who snore occasionally or frequently were more likely to be hyperuricaemia (OR 1.19, 95% CI 1.07 to 1.31; OR 1.33, 95% CI 1.19 to 1.47) compared with no snoring people. Stratification by age, gender and body mass index (BMI), we found that the positive association between snoring frequently and hyperuricaemia was insisted in different age, gender and high BMI groups, and the strength of association varied with different age, gender and BMI category.

Conclusion

Snoring frequency was positively associated with higher risk of hyperuricaemia. Snoring frequently may be a signal for hyperuricaemia, especially for women, those over 59 years of age, or those who are overweight or obese.

Randomised parallel trial on the effectiveness and cost-effectiveness in screening gait disorder of silent cerebrovascular disease assisted by artificial intelligent system versus clinical doctors (ACCURATE-1): study protocol

Por: Fei · B. · Zhao · J. · Li · X. · Tang · Y. · Qin · G. · Zhang · W. · Ding · J. · Hu · M. · Wang · X.
Introduction

Silent cerebrovascular disease (SCD), which is a common disease in the elderly, leads to cognitive decline, gait disorders, depression and urination dysfunction, and increases the risk of cerebrovascular events. Our study aims to compare the accuracy of the diagnosis of SCD-related gait disorders between the intelligent system and the clinician. Our team have developed an intelligent evaluation system for gait. This study will evaluate whether the intelligent system can help doctors make clinical decisions and predictions, which aids the early prevention and treatment of SCD.

Methods and analysis

This study is a multi-centred, prospective, randomised and controlled trial.

SCD subjects aged 60–85 years in Shanghai and Guizhou will be recruited continuously. All subjects will randomly be divided into a doctor with intelligence assistance group or a doctor group, at a 1:1 ratio. The doctor and intelligent assistant group will accept the intelligent system evaluation. The intelligent system obtains gait parameters by an Red-Green-Blue-depth camera and computer vision algorithm. The doctor group will accept the clinicians’ routine treatment procedures. Meanwhile, all subjects will accept the panel’s gait assessment and recognition rating scale as the gold standard. The primary outcome is the sensitivity of the intelligent system and clinicians to screen for gait disorders. The secondary outcomes include the healthcare costs and the incremental cost effectiveness ratio of intelligent systems and clinicians to screen for gait disorders.

Ethics and dissemination

Approval was granted by the Ethics Committee of Zhongshan Hospital affiliated with Fudan University on 26 November 2019. The approval number is B2019-027(2) R. All subjects will sign an informed consent form before enrolment. Serious adverse events will be reported to the main researchers and ethics committees. The subjects’ data will be kept strictly confidential. The results will be disseminated in peer-reviewed journals.

Trial registration number

NCT04457908

Big Data Reality Check (BDRC) for public health: to what extent the environmental health and health services research did meet the 'V criteria for big data? A study protocol

Por: Tang · P. P. · Tam · I. L. · Jia · Y. · Leung · S.-w.
Introduction

Big data technologies have been talked up in the fields of science and medicine. The V-criteria (volume, variety, velocity and veracity, etc) for defining big data have been well-known and even quoted in most research articles; however, big data research into public health is often misrepresented due to certain common misconceptions. Such misrepresentations and misconceptions would mislead study designs, research findings and healthcare decision-making. This study aims to identify the V-eligibility of big data studies and their technologies applied to environmental health and health services research that explicitly claim to be big data studies.

Methods and analysis

Our protocol follows Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P). Scoping review and/or systematic review will be conducted. The results will be reported using PRISMA for Scoping Reviews (PRISMA-ScR), or PRISMA 2020 and Synthesis Without Meta-analysis guideline. Web of Science, PubMed, Medline and ProQuest Central will be searched for the articles from the database inception to 2021. Two reviewers will independently select eligible studies and extract specified data. The numeric data will be analysed with R statistical software. The text data will be analysed with NVivo wherever applicable.

Ethics and dissemination

This study will review the literature of big data research related to both environmental health and health services. Ethics approval is not required as all data are publicly available and involves confidential personal data. We will disseminate our findings in a peer-reviewed journal.

PROSPERO registration number

CRD42021202306.

Psychometric properties of the Chinese version of the attitude towards pressure ulcer prevention instrument: A cross‐sectional survey

Abstract

To carry out the translation and cultural adaptation of the attitude towards pressure ulcer prevention instrument for use in Chinese and to analyse the validity and reliability of the adapted version of the questionnaire. In this quantitative, descriptive, cross-sectional study, after translation of the questionnaire from English to Chinese, back-translation, and assessment of equivalence between the original and back-translated version by an expert panel, the Chinese version instrument was assessed by a convenience sample of registered nurses in several hospitals in cities of China. The internal consistency and content validity of the instrument was tested, and a confirmatory factor analysis was also performed. Confirmatory factor analysis showed that the goodness of fit of the five-factor model after the scale localization was not ideal. Therefore, confirmatory factor analysis is performed to obtain the three-factor solution of comparative fit index, goodness-of-fit index, and adjusted goodness-of-fit index reaching the acceptable standard. The instrument score of nurses with wound care certification was significantly higher than that of nurses without wound care special certification. The adapted version of the instrument for Chinese nurses can be used as a tool to measure attitudes towards pressure injury prevention.

Associations among professional quality of life dimensions, burnout, nursing practice environment, and turnover intention in newly graduated nurses

Abstract

Background

Professional quality of life affects nurses’ well-being and the quality of care. However, little attention is paid to the relationships among professional quality of life dimensions, burnout, nursing practice environment, and intention to leave this job in newly graduated nurses.

Aims

To assess the levels of professional quality of life dimensions and turnover intention, to examine the predictors for turnover intention, and to explore the mediating roles of professional quality of life dimensions on the associations between these predictors and turnover intention in Chinese newly graduated nurses.

Methods

This was a cross-sectional study with 315 newly graduated nurses selected from five tertiary hospitals and five secondary hospitals in Sichuan province, China. Multiple regression analysis was used to examine the effects of demographic characteristics and work-related factors on intention to leave this job. Structural equation modeling technique was performed to explore the mediating effect of each domain of professional quality of life on the relationships between the predictors and turnover intention.

Results

The prevalence of average levels of burnout, secondary traumatic stress, and compassion satisfaction was 43.2%, 57.1%, and 81.3%, respectively. Moreover, 43.8% and 0.6% of the participants reported high and exceptionally high intention to leave this job. Nursing practice environment, social support, and empathy indirectly and significantly affected turnover intention via the mediating roles of burnout and compassion satisfaction, respectively. However, no significant mediating effect of secondary traumatic stress was found between these predictors and turnover intention.

Linking Evidence to Action

Perceptions of greater nursing practice environment, social support, and empathy result in lower turnover intention via reducing burnout and facilitating compassion satisfaction. Strategies such as developing a supportive work and family environment, and cultivating empathic capacity can be effective methods to mitigate against intention to leave this job in newly graduated nurses.

Development and testing of an opioid tapering self-management intervention for chronic pain: I-WOTCH

Por: Sandhu · H. K. · Shaw · J. · Carnes · D. · Furlan · A. D. · Tysall · C. · Adjei · H. · Muthiah · C. · Noyes · J. · Tang · N. K. Y. · Taylor · S. J. · Underwood · M. · Willis · A. · Eldabe · S. · On behalf of the I-WOTCH Team · Alleyne · Abraham · Balasubramanian · Betteley · Booth · Ha
Objectives

To describe the design, development and pilot of a multicomponent intervention aimed at supporting withdrawal of opioids for people with chronic non-malignant pain for future evaluation in the Improving the Wellbeing of people with Opioid Treated CHronic pain (I-WOTCH) randomised controlled trial.

Design

The I-WOTCH intervention draws on previous literature and collaboration with stakeholders (patient and public involvement). Intervention mapping and development activities of Behaviour Change Taxonomy are described.

Setting

The intervention development was conducted by a multidisciplinary team with clinical, academic and service user perspectives. The team had expertise in the development and testing of complex health behaviour interventions, opioid tapering and pain management in primary and secondary care, I.T programming, and software development—to develop an opioid tapering App.

Participants

The I-WOTCH trial participants are adults (18 years and over) with chronic non-malignant pain using strong opioids for at least 3 months and on most days in the preceding month.

Outcomes

A multicomponent self-management support package to help people using opioids for chronic non-malignant pain reduce opioid use.

Interventions and results

Receiving information on the impact of long-term opioid use, and potential adverse effects were highlighted as important facilitators in making the decision to reduce opioids. Case studies of those who have successfully stopped taking opioids were also favoured as a facilitator to reduce opioid use. Barriers included the need for a ‘trade-off to fill the deficit of the effect of the drug’. The final I-WOTCH intervention consists of an 8–10 week programme incorporating: education; problem-solving; motivation; group and one to one tailored planning; reflection and monitoring. A detailed facilitator manual was developed to promote consistent delivery of the intervention across the UK.

Conclusions

We describe the development of an opioid reduction intervention package suitable for testing in the I-WOTCH randomised controlled trial.

Trial registration number

ISRCTN49470934.

Burden of whooping cough in China (PertussisChina): study protocol of a prospective, population-based case-control study

Por: Yu · J. · He · H. · Zhang · Y. · Gao · Y. · Chen · C. · Xu · J. · Xu · L. · Zhang · X. · Zhou · Q. · Zhu · Y. · Tang · X. · Guo · Y. · Chen · Z. · Shao · Z.
Introduction

Pertussis is one of the top 10 diseases of children under 10 years of age, and the few vaccine-preventable diseases who is on a rise in China in recent years; however, the true burden of pertussis, including age-stratified incidence and risk factors of severe sequelae, are under-recognised. We aim to estimate the health burden of laboratory-confirmed pertussis by age groups, considering the setting of illness onset (ie, in community, outpatient and inpatient), in a Chinese population (~2.23 million in total) at two sites.

Methods and analysis

This paper describes the study design of a 1-year, prospective, age-stratified and population-based case–control study, including site selection, study population, case registry, ascertainment and enrolment, control recruitment, follow-up of case, microbiological methods, data collection, quality control activities and statistical methods used to generate incidence estimates. During June 2021 through May 2022, registry of suspected pertussis cases (namely chronic/persistent cough) will be conducted in several participating hospitals (SHs) at the two sites, which are selected based on Healthcare Utilisation and Attitudes Surveys (HUAS) carried out before study initiation. A case–control study will be conducted in the SHs and we aim to enrol a total of 1000 suspected pertussis cases (ie, all hospital admissions and the first 1–3 outpatient visits each week each hospital) and 2000 frequency matched healthy controls in community. Our primary study outcome, the laboratory-confirmed Bordetella pertussis infection, will be determined by a comprehensive laboratory methods and procedures (ie, culture, PCR and serological tests) in both cases and controls at enrolment and during 60-day’s follow-up visits. Finally, data from HUAS (ie, population size), case registry (ie, the total number of suspected pertussis cases) and case–control study (ie, the prevalence or population attributable fraction of Bordetella pertussis) will be combined to calculate incidence and its 95% CI through bootstrap method. Epidemiological analyses will be conducted to determine the risk factors associated with severe sequelae of pertussis.

Ethics and dissemination

This study has been approved by Chinese Centre for Disease Control and Prevention’s Institutional Review Board (no. ICDC-202110). Results will be disseminated via academic presentations and publication in peer-reviewed journals, and will provide valuable scientific data and some new insights into the incidence, aetiology and risk factors for severe sequelae of pertussis to academic societies and the public health authorities who is currently struggling and fighting against this burdensome disease worldwide.

Telerehabilitation for lower extremity recovery poststroke: a systematic review and meta-analysis protocol

Por: Park · S. · Tang · A. · Pollock · C. · Sakakibara · B. M.
Introduction

Approximately 30% of individuals with stroke report unmet lower extremity recovery needs after formal hospital-based rehabilitation programmes have ended. Telerehabilitation can mitigate issues surrounding accessibility of rehabilitation services by providing ongoing support to promote recovery, however, no review exists that is specific to telerehabilitation for lower extremity recovery. This paper describes the protocol of a systematic review and meta-analysis that aims to describe and evaluate the effectiveness of lower extremity-focused telerehabilitation interventions on clinical outcomes poststroke.

Methods and analysis

A systematic review of relevant electronic databases (MEDLINE, Embase, CINAHL, PsycINFO, Web of Science, Google Scholar, PEDro, PubMed and Cochrane Library) between inception and February 2022 will be undertaken to identify eligible interventional studies published in English that compared telerehabilitation focusing on lower extremity recovery to another intervention or usual care for individuals living in the community with stroke. Clinical outcomes examined will include those related to physical function and impairment, activities and participation that are typically assessed in clinical practice and research. Two reviewers will independently screen results, identify studies to be included for review, extract data and assess risk of bias. Meta-analyses will be performed if sufficient data exist. Sensitivity analyses will be performed by removing studies with low methodological quality, and subgroup analyses will be performed if data allow by stratifying papers based on salient demographic or stroke factors and comparing results. The reporting of the review will follow the recommendations of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. The quality of evidence regarding various outcomes for telerehabilitation for lower extremity recovery poststroke will be assessed according to the Grading of Recommendation, Assessment, Development and Evaluation approach.

Ethics and dissemination

No ethical approval or informed consent is needed for this systematic review. The findings of this review will be disseminated via peer-reviewed publications and conference presentations.

PROSPERO registration number

CRD42021246886.

Effect of acetazolamide on obstructive sleep apnoea in highlanders: protocol for a randomised, placebo-controlled, double-blinded crossover trial

Por: Tan · L. · Furian · M. · Li · T. · Tang · X.
Introduction

Obstructive sleep apnoea (OSA) is a highly prevalent disease that causing systemic hypertension. Furthermore, altitude-dependent hypobaric hypoxic condition and Tibetan ethnicity have been associated with systemic hypertension independent of OSA, therefore patients with OSA living at high altitude might be at profound risk to develop systemic hypertension. Acetazolamide has been shown to decrease blood pressure, improve arterial oxygenation and prevent high altitude periodic breathing in healthy volunteers ascending to high altitude and decrease blood pressure in patients with systemic hypertension at low altitude. However, the effect of acetazolamide on 24-hour blood pressure, sleep-disordered disturbance and daytime cognitive performance in patients with OSA permanently living at high altitude has not been studied.

Methods and analysis

This study protocol describes a randomised, placebo-controlled, double-blinded crossover trial. Highland residents of both sexes, aged 30–60 years, Tibetan ethnicity, living at an elevation of 3650 m and apnoea–hypopnoea index over 15/hour will be included. Participants will be randomly assigned to a 2x2 week treatment period starting with 750 mg/day acetazolamide followed by placebo treatment or vice versa, separated by a 1-week wash-out phase. Clinical assessments, 24-hour ambulatory blood pressure monitoring (ABPM), polysomnography (PSG), near-infrared spectroscopy, nocturnal fluid shift and cognitive performance will be assessed before and at the end of each treatment period. The primary outcome will be the difference in 24-hour mean blood pressure between acetazolamide therapy and placebo; secondary outcomes will be the difference in other 24-hour ABPM-derived parameters, PSG-derived parameters, cognitive performance and overnight change in different segments of fluid volume between acetazolamide therapy and placebo. Accounting for potential dropouts, 40 participants will be recruited.

Ethics and dissemination

The protocol was approved by the West China Hospital of Sichuan University Biomedical Research Ethics Committee. Recruitment will start in spring 2022. Dissemination of the results include presentations at conferences and publications in peer-reviewed journals.

Trial registration number

ChiCTR2100049304.

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