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Mediating effect of coping style on the relationship between clinical leadership and quality of work life among nurses in tertiary-level hospitals in China: a cross-sectional study

Por: Li · H. · Chang · H. · Tao · Z. · Zhang · D. · Shi · Y. · Li · X.
Objective

To explore the association between clinical leadership and quality of work life, as well as the mediating role of coping style in this relationship.

Setting

Three tertiary-level hospitals in Liaoning Province, China.

Participants

A total of 1209 nurses were recruited for this study. Registered nurses who work full time with at least 1 year of work experience were eligible as subjects. Exclusion criteria were nurses who work indirectly with patients, such as in education, administration or research.

Primary and secondary outcome measures

Questionnaires consisting of the work-related Quality of Life Scale, the Nurse Leadership Scale and the Simplified Coping Style Questionnaire, as well as a demographic data sheet, were used to collect participant information. Pearson’s correlation analysis, hierarchical multiple regression analysis, and asymptotic and resampling strategies were used to analyse the data.

Results

The mean overall quality of work life score among Chinese nurses was 3.50±0.60. After adjusting for demographic characteristics, clinical leadership was positively associated with the score of quality of work life (β=0.55, p

Conclusions

Clinical leadership was positively associated with quality of work life and coping style partially mediated the relationship between clinical leadership and quality of work life among nurses in China. Implementing measures focusing on both clinical leadership and coping style may provide success in improving the quality of work life of nurses.

Population impact of different hypertension management guidelines based on the prospective population-based Heinz Nixdorf Recall study

Por: Gronewold · J. · Kropp · R. · Lehmann · N. · Stang · A. · Mahabadi · A. · Weimar · C. · Dichgans · M. · Moebus · S. · Kröger · K. · Hoffmann · B. · Jöckel · K.-H. · Erbel · R. · Hermann · D. · on behalf of the Heinz Nixdorf Recall Study Investigative Group
Objective

Hypertension guidelines strongly differ between societies. The current American College of Cardiology/American Heart Association (ACC/AHA) guideline recommends higher proportions of the general population for antihypertensive medication than the previous American and European guidelines. How cardiovascular risk differs between persons with and without antihypertensive medication recommendation has not been examined. Additionally, the population impact of American, European and international guidelines has not been compared systematically within the same study population.

Methods

We compared the prevalence of antihypertensive medication recommendation according to the American (Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure 7 (JNC7), ACC/AHA 2017), European (European Society of Hypertension (ESH)/European Society of Cardiology (ESC) 2013/2018), and international (WHO/International Society of Hypertension (ISH) 2003, ISH 2020) guidelines in 3092 participants of the population-based Heinz Nixdorf Recall study not taking antihypertensive medication at the baseline examination (58.1±7.5 years, 48.7% males). We furthermore compared incident cardiovascular events during the 5-year follow-up between participants with and without antihypertensive medication recommendation.

Results

The ACC/AHA 2017 guideline recommended the highest percentage of participants for antihypertensive medication (45.8%) compared with the JNC7 (37.2%), ESH/ESC 2013 (17.8%), ESC/ESH 2018 (26.7%), WHO/ISH 2003 (20.3%) or ISH 2020 (25.0%) guidelines. Participants with antihypertensive medication recommendation according to the ACC/AHA 2017 guideline had a significantly higher incidence of cardiovascular events during the 5-year follow-up compared with participants without this recommendation (2.5% vs 1.1%, p=0.003).

Conclusions

Our results call for randomised controlled trials to investigate whether applying the stricter ACC/AHA 2017 recommendation leads to a reduction in cardiovascular disease.

Identifying the competencies of Chinas paediatric residents: a modified Delphi method study

Por: Wang · Y. · Wang · T. · Wang · A. · Chen · S. · Jiao · L. · Shi · J. · Feng · X. · Meng · K.
Purpose

Standardised Training of Paediatric Resident (STPR) plays an essential role in training qualified paediatricians. Until now, China had no paediatric resident competency index system to effectively guide and evaluate the competence of paediatric residents. This study aimed to establish a competency index system for paediatric residents in China to provide a reference for improving the training system and quality of STPR.

Study design and setting

This study conducted two rounds of Delphi expert consultation survey among paediatric medical experts (n=16), followed by screening, revising and supplementing indicators using the boundary value method. Next, the analytic hierarchy process was used to determine the weight of indicators and finally establish a competency index system for paediatric residents.

Results

The results of the statistical analysis revealed a positive coefficient of 100% for both rounds of expert consultation. The expert authority coefficient values were 0.82 and 0.83, and the expert coordination coefficient test was p

Conclusions

In this study, a competency index system for paediatric residents was constructed following the characteristics and quality requirements for paediatric residents in China and is expected to significantly improve the overall level of paediatricians’ medical service quality and supply.

Impact of temperature and relative humidity on the transmission of COVID-19: a modelling study in China and the United States

Por: Wang · J. · Tang · K. · Feng · K. · Lin · X. · Lv · W. · Chen · K. · Wang · F.
Objectives

We aim to assess the impact of temperature and relative humidity on the transmission of COVID-19 across communities after accounting for community-level factors such as demographics, socioeconomic status and human mobility status.

Design

A retrospective cross-sectional regression analysis via the Fama-MacBeth procedure is adopted.

Setting

We use the data for COVID-19 daily symptom-onset cases for 100 Chinese cities and COVID-19 daily confirmed cases for 1005 US counties.

Participants

A total of 69 498 cases in China and 740 843 cases in the USA are used for calculating the effective reproductive numbers.

Primary outcome measures

Regression analysis of the impact of temperature and relative humidity on the effective reproductive number (R value).

Results

Statistically significant negative correlations are found between temperature/relative humidity and the effective reproductive number (R value) in both China and the USA.

Conclusions

Higher temperature and higher relative humidity potentially suppress the transmission of COVID-19. Specifically, an increase in temperature by 1°C is associated with a reduction in the R value of COVID-19 by 0.026 (95% CI (–0.0395 to –0.0125)) in China and by 0.020 (95% CI (–0.0311 to –0.0096)) in the USA; an increase in relative humidity by 1% is associated with a reduction in the R value by 0.0076 (95% CI (–0.0108 to –0.0045)) in China and by 0.0080 (95% CI (–0.0150 to –0.0010)) in the USA. Therefore, the potential impact of temperature/relative humidity on the effective reproductive number alone is not strong enough to stop the pandemic.

Impact of parental socioeconomic status on offsprings mental health: protocol for a longitudinal community-based study

Por: Li · M. · O'Donnell · K. J. · Caron · J. · D'Arcy · C. · Meng · X.
Introduction

Socioeconomic status (SES) affects physical and mental health and cognitive functioning. The association between SES changes (SES mobility) and health has ethical and political implications in that the pernicious effects of inequality and the differential impact on social classes of economic and social policies. There is a lack of research conducted to explore the intergenerational transmission of parental SES changes on the offspring’s mental health and cognitive functioning. We aim to fill this gap and identify roles of parental SES changes in offspring’s mental health and cognitive outcomes.

Methods and analysis

This study will be based on a longitudinal cohort from the most populous municipality in the Canadian province of Quebec. Participants and their biological offspring will be invited to this study. For those with informed consent, we will collect their information on mental health, psychiatric disorders, cognitive functioning and early life experiences for offspring. Latent class growth analysis will be used to identify parental SES mobility groups. Multivariate regression analyses will be used to explore the roles of early life stress, parental SES mobility and their interactions in psychiatric disorders and cognitive functioning. Subgroup analyses (males and females) are also planned.

Ethics and dissemination

This study has been given ethical approval by the Research Ethics Board of the Douglas Mental Health University Institute (IUSMD-18/17). Each participant will provide informed consent on participation. We will disseminate research findings through publication in peer-reviewed academic journals and presentations at conferences. Lay summaries of major research findings will also be shared annually with our partners in the health system and community agencies located in the catchment area.

Protocol for a gallbladder cancer registry study in China: the Chinese Research Group of Gallbladder Cancer (CRGGC) study

Por: Ren · T. · Li · Y. · Zhang · X. · Geng · Y. · Shao · Z. · Li · M. · Wu · X. · Wang · X.-A. · Liu · F. · Wu · W. · Shu · Y. · Bao · R. · Gong · W. · Dong · P. · Dang · X. · Liu · C. · Liu · C. · Sun · B. · Liu · J. · Wang · L. · Hong · D. · Qin · R. · Jiang · X. · Zhang · X. · Xu · J. · Jia · J. · Yang · B.
Introduction

Gallbladder cancer (GBC), the sixth most common gastrointestinal tract cancer, poses a significant disease burden in China. However, no national representative data are available on the clinical characteristics, treatment and prognosis of GBC in the Chinese population.

Methods and analysis

The Chinese Research Group of Gallbladder Cancer (CRGGC) study is a multicentre retrospective registry cohort study. Clinically diagnosed patient with GBC will be identified from 1 January 2008 to December, 2019, by reviewing the electronic medical records from 76 tertiary and secondary hospitals across 28 provinces in China. Patients with pathological and radiological diagnoses of malignancy, including cancer in situ, from the gallbladder and cystic duct are eligible, according to the National Comprehensive Cancer Network 2019 guidelines. Patients will be excluded if GBC is the secondary diagnosis in the discharge summary. The demographic characteristics, medical history, physical examination results, surgery information, pathological data, laboratory examination results and radiology reports will be collected in a standardised case report form. By May 2021, approximately 6000 patient with GBC will be included. The clinical follow-up data will be updated until 5 years after the last admission for GBC of each patient. The study aimed (1) to depict the clinical characteristics, including demographics, pathology, treatment and prognosis of patient with GBC in China; (2) to evaluate the adherence to clinical guidelines of GBC and (3) to improve clinical practice for diagnosing and treating GBC and provide references for policy-makers.

Ethics and dissemination

The protocol of the CRGGC has been approved by the Committee for Ethics of Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (SHEC-C-2019–085). All results of this study will be published in peer-reviewed journals and presented at relevant conferences.

Trial registration number

NCT04140552, Pre-results.

How can the uptake of preventive behaviour during the COVID-19 outbreak be improved? An online survey of 4827 Chinese residents

Por: Mao · Y. · Chen · H. · Wang · Y. · Chen · S. · Gao · J. · Dai · J. · Jia · Y. · Xiao · Q. · Zheng · P. · Fu · H.
Objectives

The aims of this study were to assess the uptake of preventive behaviour during the COVID-19 outbreak and to investigate the factors influencing the uptake of preventive behaviour based on the theory of planned behaviour (TPB).

Design, setting and participants

A cross-sectional online survey was conducted among Chinese residents aged ≥18 years and 4827 participants from 31 provinces and autonomous regions were included in the current study. Uptake of preventive behaviour, attitude towards the spread of COVID-19 and preventive behaviour, subjective norms, perceived behavioural control, demographic characteristics and the information attention and processing mode were measured. Multivariate logistic regressions were used to identify associations between the potential influencing factors and uptake of preventive behaviour.

Results

There were 2393 (52.8%) respondents reported high uptake of preventive behaviour. Multivariate analyses demonstrated that attitude towards the behaviour, subjective norms and perceived behavioural control were significantly correlated with uptake of preventive behaviour, and perceived behavioural control was the strongest influencing factor (OR=4.09, 95% CI 3.57 to 4.69). Furthermore, systematic information processing mode was positively associated with high uptake of preventive behaviour compared with heuristic information processing mode (OR=2.16, 95% CI 1.67 to 2.81).

Conclusions

These findings are helpful for developing education and interventions to promote high uptake of preventive behaviour and enhance public health outcomes during pandemic.

Characteristics and practices of school-based cluster randomised controlled trials for improving health outcomes in pupils in the UK: a systematic review protocol

Por: Parker · K. · Nunns · M. P. · Xiao · Z. · Ford · T. · Ukoumunne · O. C.
Introduction

Cluster randomised trials (CRTs) are studies in which groups (clusters) of participants rather than the individuals themselves are randomised to trial arms. CRTs are becoming increasingly relevant for evaluating interventions delivered in school settings for improving the health of children. Schools are a convenient setting for health interventions targeted at children and the CRT design respects the clustered structure in schools (ie, pupils within classrooms/teachers within schools). Some of the methodological challenges of CRTs, such as ethical considerations for enrolment of children into trials and how best to handle the analysis of data from participants (pupils) that change clusters (schools), may be more salient for the school setting. A better understanding of the characteristics and methodological considerations of school-based CRTs of health interventions would inform the design of future similar studies. To our knowledge, this is the only systematic review to focus specifically on the characteristics and methodological practices of CRTs delivered in schools to evaluate interventions for improving health outcomes in pupils in the UK.

Methods and analysis

We will search for CRTs published from inception to 30 June 2020 inclusively indexed in MEDLINE (Ovid). We will identify relevant articles through title and abstract screening, and subsequent full-text screening for eligibility against predefined inclusion criteria. Disagreements will be resolved through discussion. Two independent reviewers will extract data for each study using a prepiloted data extraction form. Findings will be summarised using descriptive statistics and graphs.

Ethics and dissemination

This methodological systematic review does not require ethical approval as only secondary data extracted from papers will be analysed and the data are not linked to individual participants. After completion of the systematic review, the data will be analysed, and the findings disseminated through peer-reviewed publications and scientific meetings.

PROSPERO registration number

CRD42020201792.

Different doses of prucalopride in treating chronic idiopathic constipation: a meta-analysis and Bayesian analysis

Por: Yang · T. · Wang · K. · Cao · Y. · Wen · J. · Wei · S. · Li · H. · Yang · X. · Xiao · T.
Objective

This study aims to explore the incremental benefit of different doses of prucalopride in treating chronic idiopathic constipation (CIC).

Methods

PubMed, EMBASE, MEDLINE, Cochrane Library, Chinese Biomedical Database, China National Knowledge Infrastructure, VIP medicine information and Wanfang databases were comprehensively searched up to March 2020. Prospective trials with different doses of prucalopride versus placebo were selected. The frequency of spontaneous bowel movements (SBMs) per week and the treatment-emergent adverse events (TEAEs), such as headache, arrhythmia, diarrhoea, dizziness, nausea and vomiting, were first synthesised in a meta-analysis. The probability of optimal dose of prucalopride was then ranked by random-effects within Bayesian analysis.

Results

14 high-quality randomised controlled trials with 4328 patients were ultimately included. SBMs per week increased significantly after using 1 mg (OR: 2.40, 95% CI 1.32 to 4.37), 2 mg (OR: 2.55, 95% CI 1.93 to 3.36) and 4 mg (OR: 2.51, 95% CI 1.92 to 3.28) prucalopride. Bayesian analysis demonstrated 1 mg dose obtained the maximum SBMs per week (OR: 3.31, 95% credible interval 1.72 to 6.16, probability rank=0.70) indirectly compared with 2 mg and 4 mg doses. TEAEs were higher significantly in 2 mg (risk ratio (RR): 1.20, 95% CI 1.09 to 1.33) and 4 mg (RR: 1.14, 95% CI 1.07 to 1.22) prucalopride. The 1 mg dose did not reach statistical significance (RR: 1.17, 95% CI 0.94 to 1.44).

Conclusions

The study concludes that 1 mg dose at commencement could be safer in treating CIC and that 2 mg prucalopride could be more efficacious in terms of SBMs per week outcome receiving.

PROSPERO registration number

CRD42019136679.

Comparative efficacy and side-effect profile of ketamine and esketamine in the treatment of unipolar and bipolar depression: protocol for a systematic review and network meta-analysis

Por: Zhan · Z. · Wang · X. · Chen · Q. · Xiao · Z. · Zhang · B.
Introduction

Despite a range of antidepressant drugs and therapies, approximately one-third of patients fail to achieve meaningful recovery, prompting the urgent need for more effective treatment for depression. Several open-label studies randomised controlled trials (RCTs) and meta-analyses have been conducted to confirm the therapeutic efficacy and side effects of ketamine and esketamine. Esketamine is (S)- enantiomer of ketamine; however, there is limited evidence comparing esketamine and ketamine in treating unipolar and bipolar depression have been published so far.

Methods and analysis

We will include all double-blind RCTs comparing efficacy and side-effect profile of ketamine and esketamine in the treatment of unipolar and bipolar depression. Our primary outcomes will be study-defined response at endpoint assessment; dropouts due to adverse events and other adverse drug reactions. Published studies will be retrieved through relevant database searches. Reference selection and data extraction will be independently completed by two investigators, resolving inconsistencies by consensus or a discussion with the third investigator. For each outcome, we will undertake a network meta-analysis to synthesise all evidence. Local and global methods will be used to evaluate consistency. We will assess the quality of evidence contributing to network estimates with the Confidence in Network Meta-Analysis web application.

Ethics and dissemination

This work does not require ethics approval as it will be based on published studies. This review will be published in peer-reviewed journals.

PROSPERO registration number

CRD42020201559.

Effects of general versus regional anaesthesia on circadian melatonin rhythm and its association with postoperative delirium in elderly patients undergoing hip fracture surgery: study protocol for a prospective cohort clinical trial

Por: Yuan · Y. · Song · Y. · Wang · G. · Jia · Y. · Zhou · Y. · Mi · X. · Jia · X. · Wang · X. · Liu · C. · Li · Y. · Shi · C. · Han · Y. · Guo · X. · Zhang · W. · Li · Z.
Introduction

Postoperative delirium (POD) is a common neurological complication after hip fracture surgery and is associated with high morbidity and mortality in elderly patients. Although the specific mechanism of POD remains unclear, circadian rhythm disruptions have recently drawn increased attention. To date, only limited postoperative time points of plasma melatonin level measurements were recorded in previous studies, and such data cannot represent a comprehensive melatonin rhythm. The process of anaesthesia (either general anaesthesia (GA) or regional anaesthesia (RA)) is known to influence the melatonin rhythm. However, how these two anaesthesia methods differently affect the postoperative melatonin rhythm is still unknown. Therefore, we hypothesise that RA may attenuate the disruption of the melatonin rhythm, which might decrease the incidence of POD in elderly patients undergoing hip surgery.

Methods and analysis

In this prospective cohort clinical trial, 138 patients scheduled for hip fracture surgery will be divided into two groups to receive either GA or RA. The primary aim is to compare the circadian rhythm of melatonin secretion between the two groups and explore its association with the incidence of POD.

Ethics and dissemination

The study has been approved by the Medical Science Research Ethics Committees of Beijing Jishuitan Hospital (JLKS201901-04). The results of the study will be published in peer-reviewed international journals.

Trial registration number

ChiCTR1900027393.

Development and evaluation of a decision aid for family surrogate decision-makers for patients with acute kidney injury requiring renal replacement therapy (RRT) in ICUs: a study protocol

Por: Zheng · M. · Yin · C. · Cao · Y. · Zhang · Y. · Zhang · K. · Zhang · X. · Bian · W. · Wang · L.
Introduction

Shared decision making is endorsed by guidelines for both acute kidney injury and critical care medicine. However, there is still a huge need for effective interventions, especially those focusing on decisions about renal replacement therapy for intensive care unit (ICU) patients with acute kidney injury. The decision aids provide evidence-based support for shared decision making, to achieve better decisions through enhanced knowledge of treatment options and treatment aligns with patients’ preferences and values. Therefore, our objectives are to develop and evaluate a decision aid systematically and rigorously for family surrogate decision makers of ICU patients with acute kidney injury who need renal replacement therapy.

Methods and analysis

We will use a systematic development process that focuses on user-centred design to develop and evaluate the decision aid in three phases: (1) development of a draft prototype for the decision aid based on extensive literature reviews, interviews with key stakeholders and evidence synthesis; (2) alpha testing (‘near live’ usability) the decision aid during simulated clinical encounters to test its comprehensibility, acceptability and usability and (3) beta testing (‘live’ usability) to examine the aid’s clinical feasibility. User testing will be conducted using mixed-methods approach to support iterative revision of the decision aid. The IPDASi (V.4.0) will be used for following qualitative assessment. All interviews will be analysed by Colaizzi’s seven-step approach to qualitative analysis. The coding scheme will use to analyse user interactions. Questionnaire surveys will be analysed using paired sample t-tests when related to the before-and-after survey, otherwise using one-sample t-test.

Ethics and dissemination

Ethical approval for this research was obtained from the Ethics Committee of the First Affiliated Hospital of Army Medical University, PLA (Ref: KY2020104). All participants will sign a formal informed consent form. The findings will be published in peer-reviewed journals and reported in appropriate meetings.

Trial registration number

ChiCTR2000031613.

Scoping review protocol on the use of social media for health research purposes

Por: Bour · C. · Schmitz · S. · Ahne · A. · Perchoux · C. · Dessenne · C. · Fagherazzi · G.
Introduction

More than one-third of the world population uses at least one form of social media. Since their advent in 2005, health-oriented research based on social media data has largely increased as discussions about health issues are broadly shared online and generate a large amount of health-related data. The objective of this scoping review is to provide an evidence map of the various uses of social media for health research purposes, their fields of applications and their analysis methods.

Methods and analysis

This scoping review will follow the Arksey and O’Malley methodological framework (2005) as well as the Joanna Briggs Institute Reviewer’s manual. Relevant publications will be first searched on the PudMed/MEDLINE database and then on Web of Science. We will focus on literature published between January 2005 and April 2020. All articles related to the use of social media or networks for health-oriented research purposes will be included. A first search will be conducted with some keywords in order to identify relevant articles. After identifying the research strategy, a two-part study selection process will be systematically applied by two reviewers. The first part consists of screening titles and abstracts found, thanks to the search strategy, to define the eligibility of each article. In the second part, the full texts will be screened and only relevant articles will be kept. Data will finally be extracted, collated and charted to summarise all the relevant methods, outcomes and key findings in the articles.

Ethics and dissemination

This scoping review will provide an extensive overview of the use of social media for health research purposes. Opportunities as well as future ethical, methodological and technical challenges will also be discussed based on our findings to define a new research agenda. Results will be disseminated through a peer-reviewed publication.

Understanding the complexity of socioeconomic disparities in smoking prevalence in Sweden: a cross-sectional study applying intersectionality theory

Por: Axelsson Fisk · S. · Lindström · M. · Perez-Vicente · R. · Merlo · J.
Objectives

Socioeconomic disparities in smoking prevalence remain a challenge to public health. The objective of this study was to present a simple methodology that displays intersectional patterns of smoking and quantify heterogeneities within groups to avoid inappropriate and potentially stigmatising conclusions exclusively based on group averages.

Setting

This is a cross-sectional observational study based on data from the National Health Surveys for Sweden (2004–2016 and 2018) including 136 301 individuals. We excluded people under 30 years of age, or missing information on education, household composition or smoking habits. The final sample consisted on 110 044 individuals or 80.7% of the original sample.

Outcome

Applying intersectional analysis of individual heterogeneity and discriminatory accuracy (AIHDA), we investigated the risk of self-reported smoking across 72 intersectional strata defined by age, gender, educational achievement, migration status and household composition.

Results

The distribution of smoking habit risk in the population was very heterogeneous. For instance, immigrant men aged 30–44 with low educational achievement that lived alone had a prevalence of smoking of 54% (95% CI 44% to 64%), around nine times higher than native women aged 65–84 with high educational achievement and living with other(s) that had a prevalence of 6% (95% CI 5% to 7%). The discriminatory accuracy of the information was moderate.

Conclusion

A more detailed, intersectional mapping of the socioeconomic and demographic disparities of smoking can assist in public health management aiming to eliminate this unhealthy habit from the community. Intersectionality theory together with AIHDA provides information that can guide resource allocation according to the concept proportionate universalism.

What are the barriers to the completion of a home-based rehabilitation programme for patients awaiting surgery for lung cancer: a prospective observational study

Por: Catho · H. · Guigard · S. · Toffart · A.-C. · Frey · G. · Chollier · T. · Brichon · P.-Y. · Roux · J.-F. · Sakhri · L. · Bertrand · D. · Aguirre · C. · Gorain · S. · Wuyam · B. · Arbib · F. · Borel · J. C.
Objectives

Home-based rehabilitation programmes (H-RPs) could facilitate the implementation of pulmonary rehabilitation prior to resection for non-small cell lung cancer (NSCLC), but their feasibility has not been evaluated. The aim of this study was to identify determinants of non-completion of an H-RP and the factors associated with medical events occurring 30 days after hospital discharge.

Design

A prospective observational study.

Intervention

All patients with confirmed or suspected NSCLC were enrolled in a four-component H-RP prior to surgery: (i) smoking cessation, (ii) nutritional support, (iii) physiotherapy (at least one session/week) and (iv) home cycle-ergometry (at least three times/week).

Outcomes

The H-RP was defined as ‘completed’ if the four components were performed before surgery.

Results

Out of 50 patients included, 42 underwent surgery (80% men; median age: 69 (IQR 25%–75%; 60–74) years; 64% Chronic Obstructive Pulmonary Disease (COPD); 29% type 2 diabetes). Twenty patients (48%) completed 100% of the programme. The median (IQR) duration of the H-RP was 32 (19; 46) days. Multivariate analysis showed polypharmacy (n=24) OR=12.2 (95% CI 2.0 to 74.2), living alone (n=8) (single vs couple) OR=21.5 (95% CI 1.4 to >100) and a long delay before starting the H-RP (n=18) OR=6.24 (95% CI 1.1 to 36.6) were independently associated with a risk of non-completion. In univariate analyses, factors associated with medical events at 30 days were H-RP non-completion, diabetes, polypharmacy, social precariousness and female sex.

Conclusion

Facing multiple comorbidities, living alone and a long delay before starting the rehabilitation increase the risk of not completing preoperative H-RP.

Trial registration number

NCT03530059.

Second opinion programmes in Germany: a mixed-methods study protocol

Por: Bruch · D. · May · S. · Prediger · B. · Könsgen · N. · Alexandrov · A. · Mählmann · S. · Voss · K. · Liersch · S. · Loh · J.-C. · Christensen · B. · Franzen · A. · von Peter · S. · Pieper · D. · Ronckers · C. · Neugebauer · E.
Introduction

Second opinion programmes aim to support the patients’ decision-making process and to avoid treatments that are unnecessary from a medical perspective. The German second opinion directive, introduced in December 2018, constitutes a new legal framework in statutory health insurance for seeking second opinions for elective procedures and so far includes tonsillectomy, tonsillotomy, hysterectomy and shoulder arthroscopy. The directive mandates physicians who recommend one of the above-mentioned surgeries to inform their patients of their legal right to visit a certified second opinion provider. Since second opinion programmes are a fairly recent phenomenon in Germany, no comprehensive data are yet available on the degree of implementation, users, potential barriers and their effectiveness. We aim to examine the characteristics and the use of second opinion programmes as well as the needs and wishes from the perspective of (potential) users in Germany, with focus on the decision-making process, the patient–physician relationship and the motivation to seek a second opinion, as well as the role of health literacy.

Methods and analysis

Six substudies will include the following stakeholders: (1 and 2) patients with one of the four surgery-indications covered by the directive, (3) patients who electively sought an online-based second opinion, (4) patients with oncological diseases, (5) the general population and (6) medical specialists. A mixed-methods approach will be used, including questionnaires, interviews and focus groups. The data will be evaluated using quantitative descriptive analysis and qualitative content analysis. The integration of the results will take place in the form of a triangulation protocol.

Ethics and dissemination

The study protocol was approved by the Ethics Committee of the Brandenburg Medical School. The findings will be published in peer-reviewed journals and presented at scientific conferences.

Refractive outcomes after intravitreal injection of antivascular endothelial growth factor versus laser photocoagulation for retinopathy of prematurity: a meta-analysis

Por: Kong · Q. · Ming · W.-k. · Mi · X.-S.
Objective

To determine the effects of the intraocular injection of antivascular endothelial growth factor (anti-VEGF) drugs on the refractive status of infants with retinopathy of prematurity (ROP).

Design

Systematic review and meta-analysis of the refractive status of infants with ROP who receive anti-VEGF drugs.

Data sources

The PubMed, Web of Science and Embase databases and the ClinicalTrials.gov website were searched up to June 2020.

Eligibility criteria when selecting studies

We included randomised controlled trials (RCTs) and observational studies that compared refractive errors between anti-VEGF drug and laser therapies.

Data extraction and synthesis

Data extraction and risk-of-bias assessments were conducted by two independent reviewers. We used a random-effect model to pool outcomes. The outcome measures were the spherical equivalents, axial length (AL), anterior chamber depth (ACD) and lens thickness (LT).

Results

Thirteen studies involving 1850 eyes were assessed: 914 in the anti-VEGF drug group, and 936 in the control (laser) group. Children who received anti-VEGF drug treatment had less myopia than those who received laser therapy (mean difference=1.80 D, 95% CI 0.97 to 2.63, p2=78%). The AL, ACD and LT did not reach statistical significance difference between the two groups. The current evidence indicates that the refractive safety in children with ROP is better for anti-VEGF drug treatment than for laser therapy.

Conclusions

This meta-analysis indicates that anti-VEGF drug therapy results in less myopia compared with laser therapy. However, there are relatively few published articles on refractive errors in ROP, and so high-quality and powerful RCTs are needed in the future.

PROSPERO registration number

CRD42020160673.

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