Τρίτη 8 Δεκεμβρίου 2020

Study protocol for resolution of organ injury in acute pancreatitis (RESORP): an observational prospective cohort study

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Introduction

Survivors of acute pancreatitis (AP) have shorter overall survival and increased incidence of new-onset cardiovascular, respiratory, liver and renal disease, diabetes mellitus and cancer compared with the general population, but the mechanisms that explain this are yet to be elucidated. Our aim is to characterise the precise nature and extent of organ dysfunction following an episode of AP.

Methods and analysis

This is an observational prospective cohort study in a single centre comprising a University hospital with an acute and emergency receiving unit and clinical research facility. Participants will be adult patient admitted with AP. Participants will undergo assessment at recruitment, 3 months and 3 years. At each time point, multiple biochemical and/or physiological assessments to measure cardiovascular, respiratory, liver, renal and cognitive function, diabetes mellitus and quality of life. Recruitment was from 30 November 2017 to 31 May 2020; last follow-up measurements is due on 31 May 2023. The primary outcome measure is the incidence of new-onset type 3c diabetes mellitus during follow-up. Secondary outcome measures include: quality of life analyses (SF-36, Gastrointestinal Quality of Life Index); montreal cognitive assessment; organ system physiological performance; multiomics predictors of AP severity, detection of premature cellular senescence. In a nested cohort within the main cohort, individuals may also consent to multiparameter MRI scan, echocardiography, pulmonary function testing, cardiopulmonary exercise testing and pulse-wave analysis.

Ethics and dissemination

This study has received the following approvals: UK IRAS Number 178615; South-east Scotland Research Ethics Committee number 16/SS/0065. Results will be made available to AP survivors, caregivers, funders and other researchers. Publications will be open-access.

Trial registration numbers

ClinicalTrials.gov Registry (NCT03342716) and ISRCTN50581876; Pre-results.

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Adults experiences of living with pulmonary hypertension: a thematic synthesis of qualitative studies

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Objectives

Pulmonary hypertension is a life-shortening disease that has a considerable impact on quality of life. Improving our understanding of how individuals are affected and cope with the disease will help to improve services and outcomes. This review synthesises the published qualitative research that has listened to adults discuss their experiences of living with the disease.

Design

A comprehensive systematic search of four databases was conducted in May 2020: Web of Science, PubMed, PsycINFO and Cochrane Library. Suitable studies were evaluated using the Critical Appraisal Skills programme. Findings from the studies were extracted and subjected to a thematic synthesis.

Results

Nineteen articles were identified reflecting the experiences of over 1900 individuals impacted by pulmonary hypertension from Europe, North and South America and Asia. Ten studies did not report participant's WHO functional class of pulmonary hypertension, which resulted in comparing experiences between different severity difficult. All studies met the majority of the quality assessment items. Six descriptive themes emerged discussing participant's experiences of diagnosis, treatment, prognosis, healthcare professionals, impact and coping with pulmonary hypertension. Four higher order analytical themes were developed from the descriptive themes, reflecting: (i) uncertainties and anxiety that participants encountered related to pulmonary hypertension; (ii) lack of recognition of the impact of the condition; (iii) frustration at the paucity of awareness of pulmonary hypertension in society and healthcare settings and (iv) participant's accounts of transitioning through differe nt stages of living with the disease.

Conclusions

These findings form the first synthesis of experiences of life in individuals impacted by pulmonary hypertension and illustrate the multifaceted impact of the condition. The voices of numerous groups are missing from the literature highlighting the need for additional research. The results have implications for clinical practice emphasising the role of educational and psychological therapies to support those with the disease.

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Is hard physical work in the early working life associated with back pain later in life?

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Objectives

Physically demanding work increases the risk of developing musculoskeletal disorders during working life, with low back pain (LBP) as the most prevalent and debilitating musculoskeletal disorder worldwide. However, a lack of knowledge exists about the role of early working years on musculoskeletal health later in life. This study investigated whether an exposure–response association exists between physical demands in early working life and risk of LBP in later working life.

Design

Cross-sectional study.

Setting, participants and outcome measure

In the SeniorWorkingLife study, 5909 wage earners aged ≥50 years with currently sedentary work replied to a questionnaire survey in 2018 about physical work demands during their first working years (exposure) and current LBP (outcome). Associations between physical work demands in the early working years and current LBP were modelled using general linear models controlling for various confounders, combined with model-assisted weights based on national registers.

Results

Hard physical work during early working life was associated with more intense LBP later in life among senior workers with currently sedentary jobs. In the fully adjusted model, workers with 'standing/walking work with lifting/carrying' and 'heavy or fast work that is physically strenuous' during the first years of working life reported higher LBP intensity than those with sedentary work during their first working years (0.2 (95% CI, 0.0 to 0.4) and 0.6 (95% CI, 0.4 to 0.9), respectively).

Conclusion

Work involving lifting/carrying or work that is physically strenuous in early life is associated with higher intensity of LBP among older workers with currently sedentary employment. These findings suggest that early working life may have an impact on later working years and underscore the necessity for careful introduction and instruction to the working environment for retaining musculoskeletal health and prolonging working life.

Trial registration number

NCT03634410.

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Clinical and metabolic characteristics of the Diabetes Intervention Accentuating Diet and Enhancing Metabolism (DIADEM-I) randomised clinical trial cohort

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Objectives

Diabetes Intervention Accentuating Diet and Enhancing Metabolism-I (DIADEM-I) is the first randomised controlled trial (RCT) in the Middle East and North Africa (MENA) region testing the effectiveness of an intensive lifestyle intervention (ILI) for weight loss and diabetes remission. We report on the recruitment process and baseline characteristics of the DIADEM-I cohort based on origin (Middle East vs North Africa), and waist circumference.

Design

DIADEM-I is an open-label randomised, controlled, parallel group RCT recruiting young individuals (18–50 years) with early type 2 diabetes (≤3 years since diagnosis) originating from MENA. Individuals from primary care were randomised to usual medical care or ILI (total dietary replacement phase using meal replacement products, followed by staged food reintroduction and physical activity support). The primary outcome is weight loss at 12 months. Other outcomes are glycaemic control and diabetes remission.

Setting

Primary care, Qatar.

Participants

147 (73% men) randomised within DIADEM-I who were included in the final trial data analysis.

Outcome measures

Recruitment metrics, and baseline clinical and metabolic characteristics.

Results

Of 1498 people prescreened, 267 (18%) were invited for screening and 209 (78%) consented. 173 (83%) were eligible. 15 (7%) withdrew before randomisation and the remaining 158 were randomised. Mean age was 42.1 (SD 5.6) years and mean body mass index was: 36.3 (5.5) kg/m2 (women) and 34.4 (5.4) kg/m2 (men). Mean diabetes duration was 1.8 (1.0) years and mean glycosylated haemoglobin (HbA1c) was 7.0% (1.30) (52.5 mmol/mol (SD 14.3)). Participants originated from 13 countries. Those from North Africa reported greater physical activity and had lower family history of diabetes. 90% of subjects were taking diabetes medications and 31% antihypertensives. Those with greater waist circumference had significantly higher insulin resistance and lower quality of life.

Conclusion

Recruitment of participants originating from the MENA region into the RCT was successful, and study participation was readily accepted. While DIADEM-I participants originated from 13 countries, there were few baseline differences amongst participants from Middle East versus North Africa, supporting generalisability of RCT results.

Trial registration number

ISRCTN20754766; NCT03225339

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Protocol for a scoping review of outcomes in clinical studies of interventions for venous thromboembolism in adults

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Introduction

Venous thromboembolism (VTE) is a common, potentially fatal yet treatable disease. Several advances in treatment of VTE have been made over the past decades, but definition and reporting of outcomes across those studies are inconsistent. Development of an international core outcome set for clinical studies of interventions for VTE addresses this lack of standardisation. The first step in the development of a core outcome set is to conduct a scoping review which aims to generate an inclusive list of unique outcomes that have been reported in previous studies.

Methods and analysis

MEDLINE, Embase and the Cochrane Central Register of Controlled Trials will be searched with no language restriction for prospective studies reporting on interventions for treatment of VTE in patients who are adult and non-pregnant. Records will be sorted in reverse chronological order. Study screening and data extraction will be independently performed by two authors in blocks based on date of publication, starting with 2015 to 2020 and subsequent 1-year periods, until no new outcome measures are identified from the set of included studies. After homogenising spelling and combining outcomes with the same meaning, a list of unique outcomes will be determined. Those outcomes will be grouped into outcome domains. Qualitative analysis and descriptive statistics will be used to report results.

Ethics and dissemination

Ethical approval is not required for this study. The results of this scoping review will be presented at scientific conferences, published in a peer-reviewed journal, and they will provide candidate outcome domains to be considered in subsequent steps in the development of a core outcome set for clinical studies of interventions for VTE.

Protocol registration details

http://hdl.handle.net/10393/40459

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Patient-reported outcome measures (PROMs) following knee arthroplasty: a prospective cohort study protocol

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Introduction

To evaluate the quality of clinical practice, patient-reported outcome measures (PROMs) are important as certain questions could only be answered by the patient himself. PROMs help to get a better understanding what is meaningful to a patient and directly affects daily functioning. To move beyond traditional measures, we are interested in what matters to patients and developed this project. The aim of this article is to provide the protocol for our study collecting PROMs in daily medical practice from patients who undergo knee arthroplasty.

Methods and analysis

This study is a single-site, observational, prospective cohort study. We will recruit patients scheduled for a knee arthroplasty in our medical office, situated in a private clinic. After signed informed consent, patients complete self-reported questionnaires before the surgery, after 4 months, 1 year, 2 years, 3 years, 4 years and 5 years. We will use the following PROMs: Knee injury and Osteoarthritis Outcome Score, Forgotten Joint Score, EuroQol five dimensions and satisfaction. Additionally, the surgeon will complete the objective Knee Society Score. Administration of the questionnaires will be electronically or paper-based. We will assess differences between preoperative and postoperative data with paired t-test for continuous variables and Wilcoxon signed-rank test for categorical variables. To assess subgroup differences, we will use unpaired t-test for continuous variables and Mann-Whitney U test for categorical variables. To assess possible presence of bias, we will condu ct sensitivity analyses.

Ethics and dissemination

The study has been reviewed and approved by the local ethics committee in Basel, Switzerland. Written informed consent will be obtained from all patients. We will disseminate the results of the study through peer-reviewed journals, national and international conference presentations and presentations to relevant stakeholders through appropriate channels.

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Comparison of ARIMA model and XGBoost model for prediction of human brucellosis

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Objectives

Human brucellosis is a public health problem endangering health and property in China. Predicting the trend and the seasonality of human brucellosis is of great significance for its prevention. In this study, a comparison between the autoregressive integrated moving average (ARIMA) model and the eXtreme Gradient Boosting (XGBoost) model was conducted to determine which was more suitable for predicting the occurrence of brucellosis in mainland China.

Design

Time-series study.

Setting

Mainland China.

Methods

Data on human brucellosis in mainland China were provided by the National Health and Family Planning Commission of China. The data were divided into a training set and a test set. The training set was composed of the monthly incidence of human brucellosis in mainland China from January 2008 to June 2018, and the test set was composed of the monthly incidence from July 2018 to June 2019. The mean absolute error (MAE), root mean square error (RMSE) and mean absolute percentage error (MAPE) were used to evaluate the effects of model fitting and prediction.

Results

The number of human brucellosis patients in mainland China increased from 30 002 in 2008 to 40 328 in 2018. There was an increasing trend and obvious seasonal distribution in the original time series. For the training set, the MAE, RSME and MAPE of the ARIMA(0,1,1)x(0,1,1)12 model were 338.867, 450.223 and 10.323, respectively, and the MAE, RSME and MAPE of the XGBoost model were 189.332, 262.458 and 4.475, respectively. For the test set, the MAE, RSME and MAPE of the ARIMA(0,1,1)x(0,1,1)12 model were 529.406, 586.059 and 17.676, respectively, and the MAE, RSME and MAPE of the XGBoost model were 249.307, 280.645 and 7.643, respectively.

Conclusions

The performance of the XGBoost model was better than that of the ARIMA model. The XGBoost model is more suitable for prediction cases of human brucellosis in mainland China.

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