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Hoy — Septiembre 16th 2019Tus fuentes RSS

Barriers and enablers for the implementation of clinical practice guidelines in China: a mixed-method study

Por: Jin · Y. · Li · Z. · Han · F. · Huang · D. · Huang · Q. · Cao · Y. · Weng · H. · Zeng · X.-T. · Wang · X. · Shang · H.-C.
Objectives

The aim of this study was to explore perspectives and reasoning of medical staff from Class A tertiary hospitals about the factors hindering and facilitating the uptake and use of clinical practice guidelines (CPGs) during medical procedures.

Design

Mixed-method research study to collect and analyse both quantitative and qualitative data.

Setting

Class A tertiary hospitals in China.

Participants

The inclusion criteria for the questionnaire survey and qualitative research were (1) medical practitioners and (2) years of practice: above 5 years in a tertiary hospital.

Methods

Questionnaires were distributed to medical staff in 11 cities to collect quantitative data. Frequency and ranking of barriers and enablers were analysed. Spearman correlations were computed to explore the correlation between years of practice, professional title ranking and educational background with self-reported guideline adherence. Using a constructivist grounded theory method, qualitative data were generated via in-depth face-to-face interviews with Chinese medical practitioners.

Results

A total of 359 medical practitioners were surveyed and 32 medical practitioners interviewed in 11 cities. Higher frequency and higher ranking of barriers all converged on ‘lack of access’, ‘less convenient’, ‘lack of applicability’ and ‘lack of evidence from Chinese sample’. Higher frequency and higher ranking of enablers converged on ‘Short formats presentation’, ‘Utilisation of various media’, ‘Information visualisation’ and ‘Linking to patient electronic medical records’. There were no relationships between characteristics of respondents with self-reported adherence. This research produced a theoretical understanding of the experience of medical practitioners when using guidelines. Themes identified were as follows: existing intrinsic flaws in guidelines, deficient or incomplete system mechanism and being ambiguous.

Conclusion

Our findings provide a comprehensive and culturally sensitive perspective in understanding guideline implementation in China. Strategies addressing those barriers should be further discussed and researched in the future.

Patient and provider factors associated with enrolment in the pre-end-stage renal disease pay-for-performance programme in Taiwan: a cross-sectional study

Por: Hu · H.-Y. · Jian · F.-X. · Lai · Y.-j. · Yen · Y.-F. · Huang · N. · Hwang · S. J.
Objective

The incidence and prevalence of end-stage renal disease (ESRD) in Taiwan have been ranked the highest worldwide. Therefore, the National Health Insurance Administration has implemented the pre-ESRD pay-for-performance (P4P) programme since November 2006, which had significantly reduced the incidence of dialysis and all-cause mortality. This study aimed to identify the factors associated with the enrolment in the pre-ESRD P4P programme.

Design

Cross-sectional study.

Setting

The National Health Insurance research database 2007–2012 in Taiwan.

Participants

Patients with prevalent pre-ESRD aged more than 18 years between January 2007 and December 2012 were enrolled. Patient demographics and hospital characteristics between P4P and non-P4P groups were compared. A logistic regression model was used to analyse the factors associated with P4P enrolment, and a generalised estimating equation was used to verify the results.

Primary outcome measure

Enrolment in the pre-ESRD P4P programme.

Results

In total, 82 991 patients were enrolled in the programme, with a 45.6% participation rate. Patients who were males (adjusted OR (AOR)=0.89, 95% CI=0.86 to 0.91) and employed (AOR=0.95, 95% CI=0.92 to 0.97) had a significantly lower probability to be enrolled in the programme. Older patients (66–75 years old, AOR=1.23, 95% CI=1.14 to 1.33) and those with higher Charlson Comorbidities Index (CCI 5+, AOR=4.01, 95% CI=3.55 to 4.53) tended to be enrolled in the programme, while those in the 76+ years age group were not (AOR=1.03, 95% CI=0.95 to 1.13). Hospitals located in the central (AOR=1.48, 95% CI=1.05 to 2.08) and Kao-Ping regions (AOR=1.62, 95% CI=1.18 to 2.22) also tended to enrol patients in the pre-ESRD P4P programme. Enrolment rates increased over time.

Conclusion

Pre-ESRD patients of the female gender, greater age and more comorbidities were more likely to be enrolled in the pre-ESRD P4P programme. Healthcare providers and health authorities should focus attention on patients who are male, younger and with less comorbidities to improve the healthcare quality and equality for all pre-ESRD patients.

Sedation versus general anaesthesia in endovascular therapy for anterior circulation acute ischaemic stroke: the multicentre randomised controlled AMETIS trial study protocol

Por: Chabanne · R. · Fernandez-Canal · C. · Degos · V. · Lukaszewicz · A.-C. · Velly · L. · Mrozek · S. · Perrigault · P.-F. · Molliex · S. · Tavernier · B. · Dahyot-Fizelier · C. · Verdonk · F. · Caumon · E. · Masgrau · A. · Begard · M. · Chabert · E. · Ferrier · A. · Jaber · S. · Bazin · J.-
Introduction

Endovascular thrombectomy is the standard of care for anterior circulation acute ischaemic stroke (AIS) secondary to emergent large vessel occlusion in patients who qualify. General anaesthesia (GA) or conscious sedation (CS) is usually required to ensure patient comfort and avoid agitation and movement during thrombectomy. However, the question of whether the use of GA or CS might influence functional outcome remains debated. Indeed, conflicting results exist between observational studies with better outcomes associated with CS and small monocentric randomised controlled trials favouring GA. Therefore, we aim to evaluate the effect of CS versus GA on functional outcome and periprocedural complications in endovascular mechanical thrombectomy for anterior circulation AIS.

Methods and analysis

Anesthesia Management in Endovascular Therapy for Ischemic Stroke (AMETIS) trial is an investigator initiated, multicentre, prospective, randomised controlled, two-arm trial. AMETIS trial will randomise 270 patients with anterior circulation AIS in a 1:1 ratio, stratified by centre, National Institutes of Health Stroke Scale (≤15 or >15) and association of intravenous thrombolysis or not to receive either CS or GA. The primary outcome is a composite of functional independence at 3 months and absence of perioperative complication occurring by day 7 after endovascular therapy for anterior circulation AIS. Functional independence is defined as a modified Rankin Scale score of 0–2 by day 90. Perioperative complications are defined as intervention-associated arterial perforation or dissection, pneumonia or myocardial infarction or cardiogenic acute pulmonary oedema or malignant stroke evolution occurring by day 7.

Ethics and dissemination

The AMETIS trial was approved by an independent ethics committee. Study began in august 2017. Results will be published in an international peer-reviewed medical journal.

Trial registration number

NCT03229148.

Analgesic efficacy and safety of ketamine after total knee or hip arthroplasty: a meta-analysis of randomised placebo-controlled studies

Por: Xu · B. · Wang · Y. · Zeng · C. · Wei · J. · Li · J. · Wu · Z. · He · H. · Lei · G. · Xie · D. · Ding · X.
Objective

To examine the analgesic efficacy and safety of ketamine after total knee or hip arthroplasty.

Design

Systematic review and meta-analysis.

Data sources

PubMed, EMBASE and Cochrane Library from inception to 22 May 2019.

Eligibility criteria for selecting studies

Randomised controlled trials comparing the efficacy and safety of ketamine with placebo for postoperative pain relief in patients undergoing total knee or hip arthroplasty.

Data extraction and synthesis

Data (ie, pain intensity, morphine consumption, gastrointestinal and psychotic adverse effects) were extracted by two reviewers independently. The Cochrane Collaboration’s recommended tool was used to determine the methodological quality of included studies.

Results

A total of 10 studies were included. One of them was rated as low quality. Compared with placebo, intravenous ketamine was effective for pain relief during 0–8-hour (weighted mean difference (WMD) –1.21, 95% CI –1.45 to –0.98, p

Conclusions

Intravenous administration of ketamine is effective and safe for postoperative pain relief in patients undergoing total knee or hip arthroplasty. Nevertheless, the analgesic efficacy and safety of ketamine in such patients seem to vary by different administration routes and still warrant further studies to explore.

Perspective of asylum-seeking caregivers on the quality of care provided by a Swiss paediatric hospital: a qualitative study

Por: Brandenberger · J. · Sontag · K. · Duchene-Lacroix · C. · Jaeger · F. N. · Peterhans · B. · Ritz · N.
Objectives

This study investigated the perspective of asylum-seeking caregivers on the quality of healthcare delivered to their children in a qualitative in-depth interview study. The health of asylum-seeking children is of key interest for healthcare providers, yet knowledge of the perspective of asylum-seeking caregivers when accessing healthcare is limited.

Setting

The study took place in a paediatric tertiary care hospital in Basel, Switzerland.

Participants

Interviews were done with 13 asylum-seeking caregivers who had presented with their children at the paediatric tertiary care hospital. Nine female and four male caregivers from Tibet, Eritrea, Afghanistan, Syria, Iraq, Albania and Macedonia were included. A diverse sample was chosen regarding cultural and social background, years of residence in Switzerland and reasons for seeking care. A previously developed and pilot-tested interview guide was used for semistructured in-depth interviews between 36 and 92 min in duration. Data analysis and reporting was done according to Consolidated Criteria for Reporting Qualitative Research. The number of interviews was determined by saturation of data.

Results

The interviewees described a mismatch of personal competencies and external challenges. Communication barriers and unfamiliarity with new health concepts were reported as challenges. These were aggravated by isolation and concerns about their child’s health. The following factors were reported to strongly contribute to satisfaction of healthcare delivery: a respectful and trusting caregiver–provider relationship, the presence of interpreters and immediate availability of treatment.

Conclusions

A mismatch of personal competencies and external challenges importantly influences the caregiver–provider relationship. To overcome this mismatch establishment of confidence was identified as a key factor. This can be achieved by availability of interpreter services, sufficient consultation time and transcultural trainings for healthcare workers. Coordination between the family, the government’s asylum system and the medical system is required to facilitate this process.

Study protocol for a single-blind randomised controlled trial to evaluate the clinical effects of an Integrated Qigong exercise intervention on freezing of gait in Parkinsons disease

Por: Li · Z. · Zhuang · J. · Jiang · Y. · Xiao · G. · Jie · K. · Wang · T. · Yin · W. · Zhang · Y. · Wang · Z.
Introduction

Qigong exercise offers a potentially safe, low-cost and effective mind–body rehabilitative intervention for mitigating the problem of gait interruption among patients with Parkinson’s disease (PD) who have frequent freezing of gait (FOG) episodes. However, its clinical effects have not been established. This paper describes the trial protocol of evaluating the clinical efficacy of a newly developed Integrated Qigong in improving gait among patients with PD who have FOG.

Methods and analysis

A single-blind randomised controlled trial is designed to compare Integrated Qigong and balance training with an attention control. Participants will be patients with mild to moderate PD who experience FOG and are recruited from local communities in Shanghai, China. Participants will be randomly allocated to one of the three groups: Integrated Qigong group, a balance exercise intervention group, or control group. The total number of participants will be 126, and masked assessments will be made at baseline, 12 weeks (end of intervention) and 12-week follow-up. Both Integrated Qigong group and balance training group will receive a group-based exercise intervention that meets three times per week, 60 min in duration, for 12 weeks. The control group will receive a 60 min weekly group session and monthly health education. The primary outcomes are gait parameters (stride length, gait velocity, stride time variability) and occurrence of FOG. The secondary outcomes are postural instability, walking disability, falling, fear of falling and quality of life.

Ethics and dissemination

This study has been approved by the Ethics Committee of Shanghai University of Sport and registered at China Clinical Trial Registry. Participants will sign informed consent prior to the participation of the trial. The findings of the study will be published in peer-reviewed academic journals and disseminated to PD support groups, medical community and media.

Trial registration number

ChiCTR1800016570.

Burden of visual impairment associated with eye diseases: exploratory survey of 298 Chinese patients

Por: Guan · X. · Fu · M. · Lin · F. · Zhu · D. · Vuillermin · D. · Shi · L.
Objectives

To explore the economic burden, prevalence of catastrophic healthcare expenditure (CHE) and the quality of life (QoL) of Chinese patients with visual impairment (VI) associated with eye diseases.

Design

A questionnaire survey from March to May 2016 by structured face-to-face interviews of patients with VI.

Participants

302 patients who were diagnosed with moderate VI or worse in both eyes (visual acuity

Outcome measures

The economic burden was estimated by calculating participants’ direct costs covered in 2015 and the definition of CHE was out-of-pocket (OOP) costs exceeding 30% of annual household income. QoL was weighed by health utility value using time-trade-off valuation techniques.

Results

Annual average direct costs per patient caused by VI were US$6988.6±US$10 834.3, and 70.3% were direct medical costs of which only 26.9% were reimbursable by medical insurance. 32.2% of households that suffered from CHE, in particular, were less wealthy patients with VI living in rural areas and without medical insurance. The health utility value was rated at 0.65 on average, and patients with VI aged 51–57, living alone and insured by commercial medical insurance had relatively less QoL.

Conclusion

Our study explored the economic burden and QoL of VI associated with patients with eye diseases in China, indicating a substantial economic burden and poor QoL. Preferential medical insurance policies should be designed in relation to people with VI to further reduce the health inequalities, avoid CHE and promote QoL.

Simple risk score based on the China Acute Myocardial Infarction registry for predicting in-hospital mortality among patients with non-ST-segment elevation myocardial infarction: results of a prospective observational cohort study

Por: Song · C. · Fu · R. · Li · S. · Yang · J. · Wang · Y. · Xu · H. · Gao · X. · Liu · J. · Liu · Q. · Wang · C. · Dou · K. · Yang · Y.
Objectives

To simplify our previous risk score for predicting the in-hospital mortality risk in patients with non-ST-segment elevation myocardial infarction (NSTEMI) by dropping laboratory data.

Design

Prospective cohort.

Setting

Multicentre, 108 hospitals across three levels in China.

Participants

A total of 5775 patients with NSTEMI enrolled in the China Acute Myocardial Infarction (CAMI) registry.

Primary outcome measures

In-hospital mortality.

Results

The simplified CAMI-NSTEMI (SCAMI-NSTEMI) score includes the following nine variables: age, body mass index, systolic blood pressure, Killip classification, cardiac arrest, ST-segment depression on ECG, smoking status, previous angina and previous percutaneous coronary intervention. Within both the derivation and validation cohorts, the SCAMI-NSTEMI score showed a good discrimination ability (C-statistics: 0.76 and 0.83, respectively); further, the SCAMI-NSTEMI score had a diagnostic performance superior to that of the Global Registry of Acute Coronary Events risk score (C-statistics: 0.78 and 0.73, respectively; p

Conclusions

The SCAMI-NSTEMI score can serve as a useful tool facilitating rapid risk assessment among a broader spectrum of patients admitted owing to NSTEMI.

Trial registration number

NCT01874691.

Informed health choices intervention to teach primary school children in low-income countries to assess claims about treatment effects: process evaluation

Por: Nsangi · A. · Semakula · D. · Glenton · C. · Lewin · S. · Oxman · A. D. · Oxman · M. · Rosenbaum · S. · Dahlgren · A. · Nyirazinyoye · L. · Kaseje · M. · Rose · C. J. · Fretheim · A. · Sewankambo · N. K.
Background

We developed the informed health choices (IHC) primary school resources to teach children how to assess the trustworthiness of claims about the effects of treatments. We evaluated these resources in a randomised trial in Uganda. This paper describes the process evaluation that we conducted alongside this trial.

Objectives

To identify factors affecting the implementation, impact and scaling up of the intervention; and potential adverse and beneficial effects of the intervention.

Methods

All 85 teachers in the 60 schools in the intervention arm of the trial completed a questionnaire after each lesson and at the end of the term. We conducted structured classroom observations at all 60 schools. For interviews and focus groups, we purposively selected six schools. We interviewed district education officers, teachers, head teachers, children and their parents. We used a framework analysis approach to analyse the data.

Results

Most of the participants liked the IHC resources and felt that the content was important. This motivated the teachers and contributed to positive attitudes. Although some teachers started out lacking confidence, many found that the children’s enthusiasm for the lessons made them more confident. Nearly everyone interviewed thought that the children learnt something important and many thought that it improved their decision-making. The main barrier to scaling up use of the IHC resources that participants identified was the need to incorporate the lessons into the national curriculum.

Conclusion

The mostly positive findings reflect the trial results, which showed large effects on the children’s and the teachers’ critical appraisal skills. The main limitations of this evaluation are that the investigators were responsible for both developing and evaluating the intervention.

Acceptability and feasibility of weight management programmes for adults with severe obesity: a qualitative systematic review

Por: Skea · Z. C. · Aceves-Martins · M. · Robertson · C. · De Bruin · M. · Avenell · A. · on behalf of the REBALANCE team · Jacobsen · Boyers · Cooper · Retat · Aveyard · Stewart · MacLennan · Webber · Corbould · Xu · Jaccard · Boyle · Duncan · Shimonovich · Fraser · Kemp · Watson · Lie
Objectives

To improve our understanding of the acceptability of behavioural weight management programmes (WMPs) for adults with severe obesity.

Design

A systematic review of qualitative evidence.

Data sources

Medline, Embase, PsycINFO, CINAHL, SCI, SSCI and CAB abstracts were searched from 1964 to May 2017.

Eligibility criteria

Papers that contained qualitative data from adults with body mass index (BMI) ≥35 kg/m2 (and/or the views of providers involved in their care) and considered issues about weight management.

Data extraction and synthesis

Two reviewers read and systematically extracted data from the included papers which were compared, and contrasted according to emerging issues and themes. Papers were appraised for methodological rigour and theoretical relevance using Toye’s proposed criteria for quality in relation to meta-ethnography.

Results

33 papers met our inclusion criteria from seven countries published 2007–2017. Findings were presented from a total of 644 participants and 153 programme providers. Participants described being attracted to programmes that were perceived to be novel or exciting, as well as being endorsed by their healthcare provider. The sense of belonging to a group who shared similar issues, and who had similar physiques and personalities, was particularly important and seemed to foster a strong group identity and related accountability. Group-based activities were enjoyed by many and participants preferred WMPs with more intensive support. However, some described struggling with physical activities (due to a range of physical comorbidities) and not everyone enjoyed group interaction with others (sometimes due to various mental health comorbidities). Although the mean BMI reported across the papers ranged from 36.8 to 44.7 kg/m2, no quotes from participants in any of the included papers were linked to specific detail regarding BMI status.

Conclusions

Although group-based interventions were favoured, people with severe obesity might be especially vulnerable to physical and mental comorbidities which could inhibit engagement with certain intervention components.

Comparative efficacy of 13 immunosuppressive agents for idiopathic membranous nephropathy in adults with nephrotic syndrome: a systematic review and network meta-analysis

Por: Zheng · Q. · Yang · H. · Liu · W. · Sun · W. · Zhao · Q. · Zhang · X. · Jin · H. · Sun · L.
Objectives

This study aimed to compare the effectiveness of 13 types of immunosuppressive agents used to treat idiopathic membranous nephropathy (IMN) in adults with nephrotic syndrome.

Design

Systematic review and network meta-analysis.

Data sources

PubMed, EMbase, Cochrane Library, Web of Science, Clinical trials, SinoMed, Chinese Biomedicine, CNKI, WanFang and Chongqing VIP Information databases were comprehensively searched until February 2018.

Eligibility criteria

Randomised clinical trials (RCTs) comparing the effects of different immunosuppressive treatments in adult patients with IMN and nephrotic syndrome were included, and all included RCTs had a study-duration of at least 6 months.

Data extraction and synthesis

Two reviewers independently screened articles, extracted data and assessed study quality. Standard pairwise meta-analysis was performed using DerSimonian-Laird random-effects model.

Results

This study ultimately included 48 RCTs with 2736 patients and 13 immunosuppressive agents. The network meta-analysis results showed that most regimens, except for leflunomide (LEF), mizoribine (MZB) and steroids (STE), showed significantly higher probabilities of total remission (TR) when compared with non-immunosuppressive therapies (the control group),with risk ratios (RRs) of 2.71 (95% CI) 1.81 to 4.06)for tacrolimus+tripterygium wilfordii (TAC+TW), 2.16 (1.27 to 3.69) foradrenocorticotropic hormone, 2.02 (1.64 to 2.49) for TAC, 2.03 (1.13 to3.64) for azathioprine (AZA), 1.91 (1.46 to 2.50) for cyclosporine (CsA), 1.86 (1.44 to2.42) for mycophenolate mofetil (MMF), 1.85 (1.52 to 2.25) for cyclophosphamide (CTX),1.81 (1.10 to 2.98) for rituximab (RIT), 1.80 (1.38 to 2.33) for TW, 1.72 (1.35 to 2.19) for chlorambucil. As for 24 hours UTP, the direct andindirect comparisons showed that AZA (standard mean difference (SMD), –1.02(95% CI –1.90 to –0.15)), CsA (SMD, –0.70 (95% CI –1.33 to –0.08)),CTX (SMD, –1.01 (95% CI –1.44 to -0.58)), MMF (SMD, –0.98 (95% CI –1.64 to –0.32)), MZB (SMD, –0.97 (95% CI –1.90 to–0.04]), TAC (SMD, –1.16 (95% CI –1.72 to –0.60)) and TAC+TW(SMD, –2.03 (95% CI –2.94 to –1.12)) could significantly superior thancontrol, except for chlorambucil, LEF, RIT and STE. Thechanges of serum creatinine (Scr) was not significantly different between eachtreatments of immunosuppressive agents and the control, except for STE whichhas the possibility of increasing Scr (SMD, 1.00 (95% CI 0.36 to 1.64)).Comparisons among all treatments of immunosuppressive agents showed nostatistical significance in the outcome of relapse. A drenocorticotropichormone (85.1%) showed the lowest probability of relapse under the cumulativeranking curve values among all immunosuppressants. Infection,gastrointestinal symptoms, and bone marrow suppression were the common adverseevents associated with most of the immunosuppressive therapies.

Conclusions

This study demonstrates that TAC+TW, TAC and CTX are superior to other immunosuppressive agents in terms of TR and 24 hours UTP. Moreover, they are all at risk of infection, gastrointestinal symptoms, and myelosuppression. Furthermore, TAC could increase the risk of glucose intolerance or new-onset diabetes mellitus. Conversely, STE alone, LEF and MZB seem to have little advantage in clinical treatment of IMN.

PROSPERO registration number

CRD42018094228.

Tolerogenic dendritic cell-based treatment for multiple sclerosis (MS): a harmonised study protocol for two phase I clinical trials comparing intradermal and intranodal cell administration

Por: Willekens · B. · Presas-Rodriguez · S. · Mansilla · M. · Derdelinckx · J. · Lee · W.-P. · Nijs · G. · De Laere · M. · Wens · I. · Cras · P. · Parizel · P. · Van Hecke · W. · Ribbens · A. · Billiet · T. · Adams · G. · Couttenye · M.-M. · Navarro-Barriuso · J. · Teniente-Serra · A. · Quira
Introduction

Based on the advances in the treatment of multiple sclerosis (MS), currently available disease-modifying treatments (DMT) have positively influenced the disease course of MS. However, the efficacy of DMT is highly variable and increasing treatment efficacy comes with a more severe risk profile. Hence, the unmet need for safer and more selective treatments remains. Specifically restoring immune tolerance towards myelin antigens may provide an attractive alternative. In this respect, antigen-specific tolerisation with autologous tolerogenic dendritic cells (tolDC) is a promising approach.

Methods and analysis

Here, we will evaluate the clinical use of tolDC in a well-defined population of MS patients in two phase I clinical trials. In doing so, we aim to compare two ways of tolDC administration, namely intradermal and intranodal. The cells will be injected at consecutive intervals in three cohorts receiving incremental doses of tolDC, according to a best-of-five design. The primary objective is to assess the safety and feasibility of tolDC administration. For safety, the number of adverse events including MRI and clinical outcomes will be assessed. For feasibility, successful production of tolDC will be determined. Secondary endpoints include clinical and MRI outcome measures. The patients’ immune profile will be assessed to find presumptive evidence for a tolerogenic effect in vivo.

Ethics and dissemination

Ethics approval was obtained for the two phase I clinical trials. The results of the trials will be disseminated in a peer-reviewed journal, at scientific conferences and to patient associations.

Trial registration numbers

NCT02618902 and NCT02903537; EudraCT numbers: 2015-002975-16 and 2015-003541-26.

Effects of health status on work exit and absenteeism among the older working population in China: a secondary analysis of a cohort sample

Por: Li · X. · Zhang · W. · Sun · H. · Anis · A. H.
Objectives

To analyse the effects of health status on work exit and absenteeism among the older working population in China.

Design

Secondary analysis of a cohort sample.

Setting and participants

Community samples who engaged in either agricultural or non-agriculture work or both in the 2011 wave of the China Health and Retirement Longitudinal Study (CHARLS) and whose age was 45–55 years for women or 45–60 years for men in the 2013 wave.

Outcome measures

Work exit and number of absent workdays due to health problems in 2013. To address the problems of measurement error of self-rated health status, we used disability condition, number of chronic diseases and functional limitation to construct an index of health. We divided the sample into four groups according to gender and work types (farmers who conducted any agricultural work in 2011 vs non-farmers who conducted non-agricultural work only) and conducted analyses separately.

Results

Farmers (11.0% for women and 4.9% for men) were less likely to exit from work than non-farmers (18.5% and 12.0%, respectively) but took more absent workdays (16.6 days for women and 15.0 days for men) than non-farmers (5.6 and 4.9). Poor health status in 2011 was significantly associated with the work exit in 2013 of female and male farmers but not non-farmers. Older workers (except female non-farmers) with persistently poor health or recent health deterioration over time were significantly more likely to stop working or missed more workdays than those with persistently good health.

Conclusions

Poor 2-year lagged health predicts work exit for both male and female farmers, and increases the absent work days in all older working population. Persistently poor health or recent health deterioration over time has detrimental impact on labour market in terms of work exit and absenteeism among all older Chinese workers except for female non-farmers.

Association between mid-upper arm circumference and cardiometabolic risk in Chinese population: a cross-sectional study

Por: Hou · Y. · Jia · X. · Xuan · L. · Zhu · W. · Deng · C. · Wang · L. · Zhao · Z. · Li · M. · Lu · J. · Xu · Y. · Chen · Y. · Wang · W. · Bi · Y. · Xu · M. · Wang · T.
Objectives

Upper body fat has been associated with an unfavourable cardiometabolic risk. We aimed to investigate the associations between mid-upper arm circumference (MUAC), a novel indicator of upper body fat, and a wide spectrum of cardiometabolic risk profiles in Chinese population.

Design and setting

Cross-sectional analyses were performed using data from a well-defined community in 2014, Shanghai, China.

Participants

A total of 6287 Chinese adults (2310 men and 3977 women) aged 40 years or older.

Outcome measures

Multivariable logistic regression model was used to examine the associations of MUAC with cardiometabolic disorders including central obesity, diabetes, hypertension, hypertriglyceridaemia, low high-density lipoprotein (HDL) cholesterol and subclinical atherosclerosis.

Results

In the overall participants, after multivariable adjustment, each 1 SD (3.13 cm) increment in MUAC was positively associated with central obesity (OR 2.05; 95% CI 1.85 to 2.28), hypertension (OR 1.10; 95% CI 1.03 to 1.19) and low HDL cholesterol (OR 1.10; 95% CI 1.01 to 1.22). Multivariable-adjusted ORs for subclinical atherosclerosis were gradually increased across increasing quartiles of MUAC with the lowest quartile as reference (quartile 2: OR 1.31; 95% CI 1.09 to 1.58; quartile 3: OR 1.33; 95% CI 1.10 to 1.62; quartile 4: OR 1.45; 95% CI 1.16 to 1.80; p for trend=0.005). Similar but more prominent associations were observed among women than men. In addition, MUAC was significantly interacted with diabetes (p for interaction=0.04) and insulin resistance (p for interaction=0.01) on subclinical atherosclerosis.

Conclusion

A greater MUAC was positively associated with higher risks of several cardiometabolic disorders and subclinical atherosclerosis in Chinese adults.

The accuracy of diagnostic Imaging techniques in patients with a suspected Fracture-related Infection (IFI) trial: study protocol for a prospective multicenter cohort study.

Por: Govaert · G. · Hobbelink · M. · Reininga · I. · Bosch · P. · Kwee · T. · de Jong · P. · Jutte · P. · Vogely · H. · Dierckx · R. · Leenen · L. · Glaudemans · A. · IJpma · F.
Introduction

The optimal diagnostic imaging strategy for fracture-related infection (FRI) remains to be established. In this prospective study, the three commonly used advanced imaging techniques for diagnosing FRI will be compared. Primary endpoints are (1) determining the overall diagnostic performances of white blood cell (WBC) scintigraphy, fluorodeoxyglucose positron emission tomography (FDG-PET) and magnetic resonance imaging (MRI) in patients with suspected FRI and (2) establishing the most accurate imaging strategy for diagnosing FRI.

Methods and analysis

This study is a non-randomised, partially blinded, prospective cohort study involving two level 1 trauma centres in The Netherlands. All adult patients who require advanced medical imaging for suspected FRI are eligible for inclusion. Patients will undergo all three investigational imaging procedures (WBC scintigraphy, FDG-PET and MRI) within a time frame of 14 days after inclusion. The reference standard will be the result of at least five intraoperative sampled microbiology cultures, or, in case of no surgery, the clinical presence or absence of infection at 1 year follow-up. Initially, the results of all three imaging modalities will be available to the treating team as per local protocol. At a later time point, all scans will be centrally reassessed by nuclear medicine physicians and radiologists who are blinded for the identity of the patients and their clinical outcome. The discriminative ability of the imaging modalities will be quantified by several measures of diagnostic accuracy.

Ethics and dissemination

Approval of the study by the Institutional Review Board has been obtained prior to the start of this study. The results of this trial will be disseminated by publication of peer-reviewed manuscripts, presentation in abstract form at scientific meetings and data sharing with other investigators through academically established means.

Trial registration number

The IFI trial is registered in the Netherlands Trial Register (NTR7490).

Risk factors for progression of carotid intima-media thickness in patients with systemic lupus erythematosus: protocol for an observational cohort study in China

Por: Pang · H. · Ye · Y. · Ding · F. · Li · M. · Yang · X. · Yang · X. · Wang · Q. · Xu · D. · Fei · Y. · Kang · L. · Zeng · X. · Zhang · S.
Introduction

Accelerated atherosclerosis is a major complication of systemic lupus erythematosus (SLE), and it leads to increased cardiovascular morbidity and mortality in patients with SLE. This study aimed to investigate the natural progression of carotid intima-media thickness (CIMT), and to examine the risk factors for progression of CIMT and atherosclerotic plaques based on a Chinese SLE cohort.

Methods and analysis

Participants were continuously enrolled as outpatients of the Department of Rheumatology in Peking Union Medical College Hospital (PUMCH) from October 2013 to December 2016. Inclusion criteria were as follows: (1) age ≥18 years, (2) fulfilment of clinical classification criteria of SLE and (3) provision of signed written informed consent. Patients with clinically overt coronary artery disease, a history of cardiovascular disease (previous stroke, heart failure, myocardial infarction, angina or symptomatic peripheral artery disease) and malignancy, and pregnant/lactating women were excluded. The primary outcome is progression of CIMT from baseline. A total of 440 patients with SLE will be enrolled. Participants will receive follow-up surveys ~5 years after their baseline visit. A standard structural survey form, including demographic data, medical history, clinical and laboratory assessments and CIMT measurement, is planned for data collection at baseline and follow-up. The risk prediction model for progression of CIMT will be created by using a mixed effect model.

Ethics and dissemination

The study protocol was approved by the institutional review board of PUMCH (S-599). Informed consent was obtained from all participants according to the Declaration of Helsinki on Biomedical Research Involving Human Studies. All data will be managed confidentially according to guidelines and legislation. Dissemination will include publication of scientific papers and/or presentations of the study findings at international conferences.

Assessment of dialysis initiation by a fuzzy mathematics equation (ADIFE): a study protocol for a randomised controlled trial

Por: Chen · J. · Liu · Y. · Chen · X. · Sun · X. · Li · W. · Yang · W. · Li · P. · Sun · X. · Wang · D. · Jiang · H. · Shi · W. · Liu · W. · Fu · P. · Ding · X. · Chang · M. · Liu · S. · Yang · X. · Cao · N. · Chen · M. · Ni · Z. · Chen · J. · Sun · S. · Liang · X. · Wang · H. · He · Y. · Gao · B. · Wang · J.
Introduction

Starting dialysis early or late both result in a low quality of life and a poor prognosis in patients undergoing haemodialysis. However, there remains no consensus on the optimal timing of dialysis initiation, mainly because of a lack of suitable methods to assess variations in dialysis initiation time. We have established a novel equation named DIFE (Dialysis Initiation based on Fuzzy-mathematics Equation) through a retrospective, multicentre clinical cohort study in China to determine the most suitable timing of dialysis initiation. The predictors of the DIFE include nine biochemical markers and clinical variables that together influence dialysis initiation. To externally validate the clinical accuracy of DIFE, we designed the assessment of DIFE (ADIFE) study as a prospective, open-label, multicentre, randomised controlled trial to assess the clinical outcomes among patients who initiate dialysis in an optimal start dialysis group and a late-start dialysis group, based on DIFE.

Methods and analysis

A total of 388 enrolled patients with end-stage renal disease will be randomised 1:1 to the optimal start dialysis group, with a DIFE value between 30 and 35, or the late-start dialysis group, with a DIFE value less than 30, using the Randomization and Trial Supply Management system. Participants will be assessed for changes in signs and symptoms, dialysis mode and parameters, biochemical and inflammatory markers, Subjective Global Assessment, Kidney Disease Quality of Life Short Form, Cognitive Assessment, medical costs, adverse events and concomitant medication at baseline, predialysis visiting stage and postdialysis visiting stage, every 12–24 weeks. The following data will be recorded on standardised online electronic case report forms. The primary endpoint is 3-year all-cause mortality. The secondary endpoints include non-fatal cerebrocardiovascular events, annual hospitalisation rate, quality of life, medical costs and haemodialysis related complications.

Ethics and dissemination

Ethical approval was obtained from the Ethics Committee of the First Affiliated Hospital of Dalian Medical University China (registration no: YJ-KY-2017–119) and the ethics committees of all participating centres. The final results of the ADIFE trial will be presented to the study sponsor, clinical researchers and the patient and public involvement reference group. Findings will be disseminated through peer-reviewed journals, Clinical Practice Guidelines and at scientific meetings.

Trial registration number

ClinicalTrial.gov. Registry (NCT03385902); pre-results.

Intended place of residence in old age of internal migrants aged 15-64 years: a citywide cross-sectional study in Shanghai, China

Por: Zhao · J. · Su · Y. · Mao · Y. · Chen · A.-n. · Zhou · X.-p. · Zhou · W.-j. · Zhu · Q.-x.
Objectives

To explore the intentions of working-age internal migrants concerning their place of residence in old age and the relevant influencing factors.

Method

A cross-sectional survey was conducted in the 17 districts of Shanghai, China in 2013. Through multi-stage stratified sampling with probability proportional to size, 7968 internal migrants (aged 15–64 years) were selected and interviewed individually face to face. The primary outcome concerned the intended place of residence in old age of internal migrants living in Shanghai. Information was collected on demographic characteristics, health insurance, economic condition and participation in social activities. Multinomial logistic regression was performed to analyse the factors influencing migrants’ intentions concerning their place of residence in old age.

Results

A total of 7927 working-age migrants with complete data were analysed. Of these, 57.0% intended to live in their hometown in old age, 17.7% planned to remain in Shanghai and 25.3% were undecided. Those respondents who were male, less educated, from rural areas or Western China, living in rental houses or who had left family members behind in their hometowns were more likely to choose their hometown as their intended residence in old age (p

Conclusions

Most of the migrants expressed an intention to remigrate to their hometowns in old age. Education, economic capacity and social insurance influenced internal migrants in their decision. Relevant authorities should monitor the remigration pattern of ageing migrants, strengthen the senior care system and prepare health service resources that are more adequate, especially in the provinces or cities whence the migrants came.

Sickness absence and disability pension before and after first childbirth and in nulliparous women: longitudinal analyses of three cohorts in Sweden

Por: Björkenstam · C. · Orellana · C. · Laszlo · K. D. · Svedberg · P. · Voss · M. · Lidwall · U. · Lindfors · P. · Alexanderson · K.
Objective

Childbirth is suggested to be associated with elevated levels of sickness absence (SA) and disability pension (DP). However, detailed knowledge about SA/DP patterns around childbirth is lacking. We aimed to compare SA/DP across different time periods among women according to their childbirth status.

Design

Register-based longitudinal cohort study.

Setting

Sweden.

Participants

Three population-based cohorts of nulliparous women aged 18–39 years, living in Sweden 31 December 1994, 1999 or 2004 (nearly 500 000/cohort).

Primary and secondary outcome measures

Sum of SA >14 and DP net days/year.

Methods

We compared crude and standardised mean SA and DP days/year during the 3 years preceding and the 3 years after first childbirth date (Y–3 to Y+3), among women having (1) their first and only birth during the subsequent 3 years (B1), (2) their first birth and at least another delivery (B1+), and (3) no childbirths during follow-up (B0).

Results

Despite an increase in SA in the year preceding the first childbirth, women in the B1 group, and especially in B1+, tended to have fewer SA/DP days throughout the years than women in the B0 group. For cohort 2005, the mean SA/DP days/year (95% CIs) in the B0, B1 and B1+ groups were for Y–3: 25.3 (24.9–25.7), 14.5 (13.6–15.5) and 8.5 (7.9–9.2); Y–2: 27.5 (27.1–27.9), 16.6 (15.5–17.6) and 9.6 (8.9–10.4); Y–1: 29.2 (28.8–29.6), 31.4 (30.2–32.6) and 22.0 (21.2–22.9); Y+1: 30.2 (29.8–30.7), 11.2 (10.4–12.1) and 5.5 (5.0–6.1); Y+2: 31.7 (31.3–32.1), 15.3 (14.2–16.3) and 10.9 (10.3–11.6); Y+3: 32.3 (31.9–32.7), 18.1 (17.0–19.3) and 12.4 (11.7–13.0), respectively. These patterns were the same in all three cohorts.

Conclusions

Women with more than one childbirth had fewer SA/DP days/year compared with women with one childbirth or with no births. Women who did not give birth had markedly more DP days than those giving birth, suggesting a health selection into childbirth.

Association of diabetic retinopathy and diabetic macular oedema with renal function in southern Chinese patients with type 2 diabetes mellitus: a single-centre observational study

Por: Zhuang · X. · Cao · D. · Yang · D. · Zeng · Y. · Yu · H. · Wang · J. · Kuang · J. · Xie · J. · Zhang · S. · Zhang · L.
Background and objectives

The association of diabetic retinopathy (DR) and diabetic macular oedema (DME) with renal function in southern Chinese patients with diabetes is poorly understood. So we aimed to study the correlation between stage of DR and DME with stage of estimated glomerular filtration rate (eGFR) and stage of urine albumin-to-creatinine ratio (UACR), and to explore the systemic risk factors for DR and DME.

Design and setting

This single-centre retrospective observational study was conducted from December 2017 to November 2018.

Participants

413 southern Chinese patients with type 2 diabetes mellitus.

Outcome measures

The correlations between stage of DR and DME with stage of eGFR/UACR were assessed by Spearman’s or ² analyses and represented with histograms. Risk factors associated with the occurrence of DR and DME were performed by logistic regression and represented with nomograms.

Results

Stage of DR had a positive correlation with stage of eGFR (r=0.264, p

Conclusions

Among southern Chinese patients, stage of DR and DME were positively correlated with renal function, while stage of UACR performed a better relevance than stage of eGFR.

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